| Page Range | 4769-5329 | |
| FR Document |
| Page and Subject | |
|---|---|
| 82 FR 5325 - Exclusions From the Federal Labor-Management Relations Program | |
| 82 FR 5323 - Designating the World Organisation for Animal Health as a Public International Organization Entitled To Enjoy Certain Privileges, Exemptions, and Immunities | |
| 82 FR 5321 - Amending Executive Order 11016 To Update Eligibility Criteria for Award of the Purple Heart | |
| 82 FR 4925 - Sunshine Act Meeting | |
| 82 FR 4880 - Sunshine Act Meeting | |
| 82 FR 4866 - Proposed Consent Decree, Clean Air Act Citizen Suit | |
| 82 FR 4864 - Denial of Reconsideration and Administrative Stay of the Emission Guidelines for Greenhouse Gas Emissions and Compliance Times for Electric Utility Generating Units | |
| 82 FR 4867 - California State Motor Vehicle Pollution Control Standards; Amendments to On-Highway Heavy-Duty Vehicle In-Use Compliance Program, Amendments to 2007 and Subsequent Model Year On-Highway Heavy-Duty Engines and Vehicles, and Amendments to Truck Requirements; Notice of Decision | |
| 82 FR 4769 - Eliminating Exception to Expedited Removal Authority for Cuban Nationals Arriving by Air | |
| 82 FR 4902 - Eliminating Exception To Expedited Removal Authority for Cuban Nationals Encountered in the United States or Arriving by Sea | |
| 82 FR 4915 - Indian Entities Recognized and Eligible To Receive Services From the United States Bureau of Indian Affairs | |
| 82 FR 4926 - Biweekly Notice: Applications and Amendments to Facility Operating Licenses and Combined Licenses Involving No Significant Hazards Considerations | |
| 82 FR 4925 - Program-Specific Guidance About Possession Licenses for Production of Radioactive Material Using an Accelerator | |
| 82 FR 4771 - Eliminating Exception to Expedited Removal Authority for Cuban Nationals Arriving by Air | |
| 82 FR 4842 - Order Relating To Berty Tyloo | |
| 82 FR 4923 - Notice Pursuant to the National Cooperative Research and Production Act of 1993-UHD Alliance, Inc. | |
| 82 FR 4856 - North Pacific Fishery Management Council; Public Meeting | |
| 82 FR 4877 - Information Collections Being Reviewed by the Federal Communications Commission | |
| 82 FR 4874 - Information Collection Being Reviewed by the Federal Communications Commission Under Delegated Authority | |
| 82 FR 4846 - Certain Corrosion-Resistant Steel Flat Products From the Republic of Korea: Notice of Court Decision Not in Harmony With Final Results and Notice of Amended Final Results | |
| 82 FR 4889 - Proposed Information Collection Activity; Submission for OMB Review; Comment Request; Protection and Advocacy Annual Program Performance Report and Statement of Goals and Priorities | |
| 82 FR 4888 - Agency Information Collection Activities: Proposed Collection; Public Comment Request; Protection and Advocacy for Traumatic Brain Injury (PATBI) Program Performance Report | |
| 82 FR 4913 - Order of Succession for the Office of Strategic Planning and Management | |
| 82 FR 4963 - Notice of Request for Revision of a Currently Approved Information Collection | |
| 82 FR 4959 - Buy America Handbook-Conducting Pre-Award and Post-Delivery Audits for Rolling Stock Procurements | |
| 82 FR 4915 - Land Acquisitions; Craig Tribal Association, Craig, Alaska | |
| 82 FR 4841 - Foreign-Trade Zone 124-Gramercy, Louisiana, Application for Reorganization, (Expansion of Service Area) Under Alternative Site Framework | |
| 82 FR 4848 - Certain New Pneumatic Off-the-Road Tires From India: Final Negative Determination of Sales at Less Than Fair Value and Final Determination of Critical Circumstances | |
| 82 FR 4863 - Termination of Department of Defense Federal Advisory Committees | |
| 82 FR 4842 - Foreign-Trade Zone (FTZ) 277-Western Maricopa County, Arizona Notification of Proposed Production Activity; IRIS USA, Inc. (Plastic Household Storage/Organizational Containers), Surprise, Arizona | |
| 82 FR 4921 - Off-road Vehicle Management Plan, Final Environmental Impact Statement, Glen Canyon National Recreation Area, Arizona and Utah | |
| 82 FR 4864 - Nuclear Energy Advisory Committee | |
| 82 FR 4887 - Agency Information Collection Activities: Submission for OMB Review; Comment Request | |
| 82 FR 4862 - Charter Amendment of Department of Defense Federal Advisory Committees | |
| 82 FR 4887 - Agency Information Collection Activities: Proposed Collection; Comment Request | |
| 82 FR 4957 - 30-Day Notice of Proposed Information Collection: Application to Determination Returning Resident Status | |
| 82 FR 4892 - Compliance Policy for Required Warning Statements on Small-Packaged Cigars; Draft Guidance for Industry; Availability | |
| 82 FR 4900 - Delay of Effective Date for the Automated Commercial Environment (ACE) Becoming the Sole CBP-Authorized Electronic Data Interchange (EDI) System for Processing Electronic Drawback and Duty Deferral Entry and Entry Summary Filings | |
| 82 FR 4879 - Information Collection Being Submitted for Review and Approval to the Office of Management and Budget | |
| 82 FR 4874 - Information Collection Being Submitted for Review and Approval to the Office of Management and Budget | |
| 82 FR 4873 - Information Collection Being Reviewed by the Federal Communications Commission Under Delegated Authority | |
| 82 FR 4837 - Petition for Reconsideration of Action in Rulemaking Proceeding | |
| 82 FR 4875 - Information Collections Being Submitted for Review and Approval to the Office of Management and Budget | |
| 82 FR 4883 - Formations of, Acquisitions by, and Mergers of Bank Holding Companies | |
| 82 FR 4793 - Sudanese Sanctions Regulations | |
| 82 FR 4850 - Ammonium Sulfate From the People's Republic of China: Final Affirmative Countervailing Duty Determination | |
| 82 FR 4883 - Agency Information Collection Activities: Announcement of Board Approval Under Delegated Authority and Submission to OMB | |
| 82 FR 4880 - Agency Information Collection Activities: Announcement of Board Approval Under Delegated Authority and Submission to OMB | |
| 82 FR 4901 - Delayed Effective Date for Modifications of the National Customs Automation Program Tests Regarding Reconciliation, Post-Summary Corrections, and Periodic Monthly Statements | |
| 82 FR 4781 - Revisions to Sudan Licensing Policy | |
| 82 FR 4920 - Public Land Order No. 7860; Partial Revocation of a Secretarial Order and a Bureau of Reclamation Order; Montana | |
| 82 FR 4885 - Proposed Data Collection Submitted for Public Comment and Recommendations | |
| 82 FR 4838 - Announcement of Application Deadlines and Requirements for Section 313A Guarantees for Bonds and Notes Issued for Electrification or Telephone Purposes Loan Program for Fiscal Year (FY) 2017 | |
| 82 FR 4863 - Submission for OMB Review; Comment Request | |
| 82 FR 4965 - Hazardous Materials: Information Collection Activities | |
| 82 FR 4844 - Tapered Roller Bearings and Parts Thereof, Finished and Unfinished, From the People's Republic of China: Final Results of Antidumping Duty Administrative Review, and Rescission of New Shipper Review; 2014-2015 | |
| 82 FR 4853 - Tapered Roller Bearings and Parts Thereof, Finished and Unfinished, From the People's Republic of China: Final Results of Changed Circumstances Review and Reinstatement of Shanghai General Bearing Co., Ltd. in the Antidumping Duty Order | |
| 82 FR 4852 - Chlorinated Isocyanurates From the People's Republic of China: Final Results of Antidumping Duty Administrative Review; 2014-2015 | |
| 82 FR 4965 - Solicitation of Proposals for Designation of Beyond Traffic Innovation Centers | |
| 82 FR 4938 - Category 3 Source Security and Accountability; Correction | |
| 82 FR 4896 - Public Hearing: Strategic Partnerships To Enhance the Safety of Imported Foods: Capacity Building, Risk-Based Decisionmaking, Recognition of Commodity Food Control Programs, and Systems Recognition; Request for Comments | |
| 82 FR 4894 - Referencing Approved Drug Products in Abbreviated New Drug Application Submissions; Draft Guidance for Industry; Availability | |
| 82 FR 4803 - Control of Listeria monocytogenes in Ready-To-Eat Foods: Revised Draft Guidance for Industry; Availability | |
| 82 FR 4861 - Mid-Atlantic Fishery Management Council (MAFMC); Public Meeting | |
| 82 FR 4861 - Multistakeholder Process on Internet of Things Security Upgradability and Patching | |
| 82 FR 4859 - Proposed Information Collection; Comment Request; Atlantic Sea Scallops Amendment 10 Data Collection | |
| 82 FR 4884 - Agency Forms Undergoing Paperwork Reduction Act Review | |
| 82 FR 4957 - Release of Waybill Data | |
| 82 FR 4864 - Notice of Availability of Government-Owned Inventions; Available for Licensing | |
| 82 FR 4863 - Meeting of the Ocean Research Advisory Panel | |
| 82 FR 4855 - Endangered Species; File No. 19508 | |
| 82 FR 4958 - Supplemental Environmental Impact Statement: Hillsborough County, Florida | |
| 82 FR 4860 - Marine Mammals; File Nos. 19703 and 20993 | |
| 82 FR 4924 - Agency Information Collection Activities; Submission for OMB Review; Comment Request; Notice of Law Enforcement Officer's Injury or Occupational Disease and Notice of Law Enforcement Officer's Death | |
| 82 FR 4858 - Marine Mammals; File No. 20043 | |
| 82 FR 4859 - Pacific Fishery Management Council; Public Meetings and Hearings | |
| 82 FR 4842 - Submission for OMB Review; Comment Request; Voluntary Self-Disclosure of Antiboycott Violations | |
| 82 FR 4967 - Loan Guaranty: Specially Adapted Housing Assistive Technology Grant Program | |
| 82 FR 4890 - Comparative Analyses and Related Comparative Use Human Factors Studies for a Drug-Device Combination Product Submitted in an Abbreviated New Drug Application; Draft Guidance for Industry; Availability | |
| 82 FR 4923 - Agency Information Collection Activities; Proposed eCollection eComments Requested; Revision of a Currently Approved Collection: Office for Victims of Crime Training and Technical Assistance Center-Trafficking Information Management System (TIMS) | |
| 82 FR 4964 - Proposed General Directive 17-1; Stop Signal Overruns on Rail Fixed Guideway Public Transportation Systems | |
| 82 FR 4899 - Agency Information Collection Activities: Submission to OMB for Review and Approval; Public Comment Request; National Hospital Organ Donation Campaign's Activity Scorecard | |
| 82 FR 4856 - Atlantic Highly Migratory Species; Exempted Fishing Permits | |
| 82 FR 4938 - National Nanotechnology Initiative Meetings | |
| 82 FR 4902 - National Infrastructure Advisory Council | |
| 82 FR 4922 - Certain Industrial Control System Software, Systems Using Same and Components Thereof; Commission Determination Not To Review an Initial Determination Terminating the Investigation Based on a Settlement Agreement; Termination of the Investigation | |
| 82 FR 4947 - Self-Regulatory Organizations; The NASDAQ Stock Market LLC; Notice of Filing and Immediate Effectiveness of Proposed Rule Change To Reduce the All-Inclusive Annual Listing Fee for Limited Partnerships Listed on Nasdaq | |
| 82 FR 4941 - Self-Regulatory Organizations; Bats EDGX Exchange, Inc.; Notice of Filing and Immediate Effectiveness of a Proposed Rule Change To Modify the Fee Schedule of the Exchange's Options Platform To Adopt Fees for its Recently Adopted Bats Auction Mechanism | |
| 82 FR 4956 - Self-Regulatory Organizations; BOX Options Exchange LLC; Notice of Designation of Longer Period for Commission Action on a Proposed Rule Change To Adopt Rules for an Open-Outcry Trading Floor | |
| 82 FR 4950 - Self-Regulatory Organizations; NYSEArca, Inc.; Order Granting Approval of Proposed Rule Change, as Modified by Amendment No. 1 Thereto, Relating to a Change to the Underlying Index for the PowerShares Build America Bond Portfolio | |
| 82 FR 4954 - Self-Regulatory Organizations; Bats BZX Exchange, Inc.; Notice of Filing and Immediate Effectiveness of a Proposed Rule Change Amending Fees To Adopt a New Cross-Asset Step-Up Tier | |
| 82 FR 4938 - Brown Advisory LLC; Notice of Application | |
| 82 FR 4893 - Interpretation of and Compliance Policy for Certain Label Requirement; Applicability of Certain Federal Food, Drug, and Cosmetic Act Requirements to Vape Shops; Draft Guidance for Industry; Availability | |
| 82 FR 4956 - Notice of Determinations; Culturally Significant Objects Imported for Exhibition Determinations: “Enlightened Princesses: Caroline, Augusta, Charlotte, and the Shaping of the Modern World” Exhibition | |
| 82 FR 4841 - Agenda and Notice of Public Meeting of the Delaware Advisory Committee; Correction | |
| 82 FR 4880 - Notice to All Interested Parties of the Termination of the Receivership of 10359-Community Central Bank, Mount Clemens, Michigan | |
| 82 FR 4967 - Sanctions Actions Pursuant to Executive Order 13224 | |
| 82 FR 4855 - Visiting Committee on Advanced Technology | |
| 82 FR 4914 - Endangered Species; Receipt of Applications for Permit | |
| 82 FR 4957 - Public Notice for Waiver of Aeronautical Land-Use Assurance | |
| 82 FR 4956 - Notice of Determinations; Culturally Significant Objects Imported for Exhibition Determinations: “Alexei Jawlensky” Exhibition | |
| 82 FR 4805 - Use of Lead Free Pipes, Fittings, Fixtures, Solder and Flux for Drinking Water | |
| 82 FR 4783 - Juvenile Justice and Delinquency Prevention Act Formula Grant Program | |
| 82 FR 4911 - Waiver of Requirements for the State of New York: CDBG Disaster Recovery Grants for Recovery of Lower Manhattan | |
| 82 FR 4796 - Civil Monetary Penalties-2017 Adjustment | |
| 82 FR 4798 - Importation of Hass Avocados From Colombia | |
| 82 FR 4800 - Donations of Technology and Support Services To Enforce Intellectual Property Rights | |
| 82 FR 5238 - International Entrepreneur Rule | |
| 82 FR 4794 - Security Zones; Annual Events in the Captain of the Port Detroit Zone-North American International Auto Show, Detroit River, Detroit MI | |
| 82 FR 4798 - Proposed Amendment of Class E Airspace, Atlantic City, NJ | |
| 82 FR 4795 - Repayment by VA of Educational Loans for Certain Psychiatrists; Correction | |
| 82 FR 4778 - Airworthiness Directives; The Boeing Company Airplanes | |
| 82 FR 4825 - Procedures for Prioritization of Chemicals for Risk Evaluation Under the Toxic Substances Control Act | |
| 82 FR 4974 - Medicare Program: Changes to the Medicare Claims and Entitlement, Medicare Advantage Organization Determination, and Medicare Prescription Drug Coverage Determination Appeals Procedures | |
| 82 FR 4773 - Airworthiness Directives; Airbus Airplanes | |
| 82 FR 4775 - Airworthiness Directives; The Boeing Company Airplanes | |
| 82 FR 4905 - Extension of the Designation of Somalia for Temporary Protected Status | |
| 82 FR 5182 - Revisions to the Guideline on Air Quality Models: Enhancements to the AERMOD Dispersion Modeling System and Incorporation of Approaches To Address Ozone and Fine Particulate Matter | |
| 82 FR 5292 - Unified Registration System; Suspension of Effectiveness | |
| 82 FR 5142 - Revisions to National Emission Standards for Radon Emissions From Operating Mill Tailings |
Animal and Plant Health Inspection Service
Rural Utilities Service
Foreign-Trade Zones Board
Industry and Security Bureau
International Trade Administration
National Institute of Standards and Technology
National Oceanic and Atmospheric Administration
National Telecommunications and Information Administration
Navy Department
Centers for Disease Control and Prevention
Centers for Medicare & Medicaid Services
Community Living Administration
Food and Drug Administration
Health Resources and Services Administration
Coast Guard
U.S. Citizenship and Immigration Services
U.S. Customs and Border Protection
Fish and Wildlife Service
Indian Affairs Bureau
Land Management Bureau
National Park Service
Antitrust Division
Executive Office for Immigration Review
Federal Aviation Administration
Federal Highway Administration
Federal Motor Carrier Safety Administration
Federal Transit Administration
Pipeline and Hazardous Materials Safety Administration
Foreign Assets Control Office
Consult the Reader Aids section at the end of this issue for phone numbers, online resources, finding aids, and notice of recently enacted public laws.
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Office of the Secretary, Department of Homeland Security.
Final rule; request for comments.
This final rule revises Department of Homeland Security (DHS) regulations to eliminate the categorical exception from expedited removal proceedings for Cuban nationals who arrive in the United States at a port of entry by aircraft. As a result of these changes, Cuban nationals who arrive in the United States at a port of entry by aircraft will be subject to expedited removal proceedings commensurate with nationals of other countries.
This final rule is effective January 13, 2017. Interested persons are invited to submit written comments on this final rule on or before March 20, 2017.
You may submit comments, identified by Regulatory Information Number (RIN) 1601-AA81 and DHS Docket Number DHS-2017-0003, by any one of the following methods:
•
•
Please submit your comments by only one method. Comments received by means other than those listed above or received after the comment period has closed will not be reviewed. All comments received will be posted without change on
Postal delivery in Washington, DC, may be delayed due to security concerns. Therefore, DHS encourages the public to submit comments through the
Amanda Baran, Principal Director for Immigration Policy, 202-282-8805,
Section 302 of the Illegal Immigration Reform and Immigrant Responsibility Act of 1996 (IIRIRA), Public Law 104-208, Div. C, 110 Stat. 3009-546, amended section 235(b) of the Immigration and Nationality Act (“Act”), 8 U.S.C. 1225(b), to authorize what are known as “expedited removal proceedings.” Specifically, section 235(b) was amended to authorize the Attorney General (now the Secretary of Homeland Security
Expedited removal proceedings under section 235(b) of the Act, 8 U.S.C. 1225(b), may be applied to two categories of aliens. First, expedited removal proceedings may be used for aliens who are “arriving in the United States.” Section 235(b)(1)(A)(i) of the Act, 8 U.S.C. 1225(b)(1)(A)(i). Second, the Secretary, in his or her sole and unreviewable discretion, may designate certain other aliens to whom the expedited removal provisions may be applied. Section 235(b)(1)(A)(iii), 8 U.S.C. 1225(b)(1)(A)(iii);
When it created the expedited removal process, Congress also created a limited exception for certain aliens who arrived at a U.S. port of entry by aircraft. Under section 235(b)(1)(F) of the Act, 8 U.S.C. 1225(b)(1)(F), expedited removal “shall not apply to an alien who is a native or citizen of a country in the Western Hemisphere with whose government the United States does not have full diplomatic relations and who arrives by aircraft at a port of entry.” For many years, this exception applied to Cuban nationals due to the lack of full diplomatic relations between the United States and Cuba. DHS regulations implementing section 235(b)(1) of the Act, 8 U.S.C. 1225(b)(1), thus expressly stated that the expedited removal provisions apply to “[a]rriving aliens, as defined in 8 CFR 1.2, except for citizens of Cuba arriving at a United States port-of-entry by aircraft.” 8 CFR 235.3(b)(1)(i);
Since that regulation was promulgated, significant changes in the relationship between the United States and Cuba have occurred. In December 2014, President Obama announced a historic opening between the United States and Cuba, as well as an approach for reestablishing diplomatic relations and adjusting regulations to facilitate greater travel, commerce, people-to-people ties, and the free flow of information to, from, and within Cuba. On July 20, 2015, the United States and Cuba formally reestablished full diplomatic relations and opened embassies in each other's countries. In the time following the reestablishment of full diplomatic relations, the United States and Cuba have taken concrete steps towards enhancing security, building bridges between our peoples, and promoting economic prosperity for citizens of both countries. And recent migration discussions have yielded important changes that will dramatically affect travel and migration between our two countries. Among other things, Cuba has agreed to accept and facilitate the repatriation of its nationals who are ordered removed from the United States. This arrangement and other changes remain the focus of ongoing diplomatic discussions between the two countries. DHS, in consultation with the Department of State, has determined that the limitation at section 235(b)(1)(F) of the Act, 8 U.S.C. 1225(b)(1)(F) no longer applies with respect to Cuba.
Moreover, DHS has recently seen a significant increase in attempts by Cuban nationals to illegally enter the United States. Many of those Cuban nationals have taken a dangerous journey through Central America and Mexico; others have taken to the high seas in the dangerous attempt to cross the Straits of Florida. DHS believes this increase in attempted migration has been driven in part by the perception that there is a limited window before the United States will eliminate favorable immigration policies for Cuban nationals.
The application of the expedited removal authorities to Cuban nationals must reflect these new realities. Accordingly, DHS is eliminating provisions in its regulations that categorically exempt Cuban nationals who arrive at a U.S. port of entry by aircraft from expedited removal proceedings under 8 CFR 235.3. Importantly, the statutory provision categorically barring the use of expedited removal for certain aliens who arrive by air no longer applies to Cuban nationals, as the United States and Cuba have reestablished full diplomatic relations. Moreover, previous U.S. policy justifications for exempting Cuban nationals from expedited removal—including Cuba's general refusal to accept the repatriation of its nationals—are no longer valid in many respects. Finally, a categorical exception severely impairs the Government's ability to remove unauthorized aliens encountered within the United States. For these reasons, DHS, in consultation with the Department of State, has determined that a categorical exception from expedited removal for Cuban nationals is no longer in the interests of the United States. Accordingly, as a result of this final rule, Cuban nationals will be subject to expedited removal proceedings under section 235(b) of the INA and 8 CFR 235.3 like nationals of other countries. For the same reasons, DHS is also publishing a notice in this issue of the
The implementation of this rule as a final rule, with provisions for post-promulgation public comments, is based on the good cause exception found in section 553 of the Administrative Procedure Act (APA) (5 U.S.C. 553(b)(B)). Delaying the implementation of the change announced in this rule to allow pre-promulgation notice and comment would be impracticable and contrary to the public interest. Congress explicitly authorized the Secretary of Homeland Security to designate categories of aliens to whom expedited removal proceedings may be applied, and made clear that “[s]uch designation shall be in the sole and unreviewable discretion of the Secretary and may be modified at any time.” Section 235(b)(1)(A)(iii)(I) of the Act, 8 U.S.C. 1225(b)(1)(A)(iii)(I). And this rule is necessary to remove quickly from the United States certain Cuban nationals who arrive by air at U.S. ports of entry. The ability to detain such aliens while admissibility and identity are determined and protection claims are adjudicated, as well as to quickly remove those without protection claims or claims to lawful status, is a necessity for national security and public safety.
Pre-promulgation notice and comment would undermine these interests, while endangering human life and having a potential destabilizing effect in the region. Specifically, DHS is concerned that publication of the rule as a proposed rule, which would signal a significant change in policy while permitting continuation of the exception for Cuban nationals, could lead to a surge in migration of Cuban nationals seeking to travel to and enter the United States during the period between the publication of a proposed and a final rule. Such a surge would threaten national security and public safety by diverting valuable Government resources from counterterrorism and homeland security responsibilities. A surge could also have a destabilizing effect on the region, thus weakening the security of the United States and threatening its international relations. Additionally, a surge could result in significant loss of human life. Accordingly, DHS finds that it would be impracticable and contrary to the public interest to accept pre-promulgation comments on this rule. For the same reasons, DHS also finds good cause to issue this rule without a 30-day delayed effective date requirement of the APA,
In addition, the change implemented by this rule is part of a major foreign policy initiative announced by the President, and is central to ongoing diplomatic discussions between the United States and Cuba with respect to travel and migration between the two countries. DHS, in consultation with the Department of State, has determined that eliminating the exception from expedited removal proceedings for Cuban nationals involves a foreign affairs function of the United States, 5 U.S.C. 553(a)(1), and is also exempt from the notice and comment and 30-day delayed effective date requirements of the APA on that basis. DHS is
Executive Orders 13563 and 12866 direct agencies to assess the costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, distributive impacts, and equity). Executive Order 13563 emphasizes the importance of quantifying both costs and benefits, of reducing costs, of harmonizing rules, and of promoting flexibility.
The Office of Management and Budget has not designated this rule as a significant regulatory action under section 3(f) of Executive Order 12866. Accordingly, the Office of Management and Budget has not reviewed this rule.
The Regulatory Flexibility Act (5 U.S.C. 601
Administrative practice and procedure, Aliens, Immigration, Reporting and recordkeeping requirements.
For the reasons stated in the preamble, part 235 of title 8 of the Code of Federal Regulations is amended as set forth below:
8 U.S.C. 1101 and note, 1103, 1183, 1185 (pursuant to E.O. 13323, 69 FR 241, 3 CFR, 2004 Comp., p. 278), 1201, 1224, 1225, 1226, 1228, 1365a note, 1365b, 1379, 1731-32; Title VII of Public Law 110-229; 8 U.S.C. 1185 note (section 7209 of Pub. L. 108-458); Pub. L. 112-54.
(b) * * *
(1) * * *
(i) Arriving aliens, as defined in 8 CFR 1.2;
Executive Office for Immigration Review, Department of Justice.
Final rule; request for comments.
This final rule revises Executive Office for Immigration Review (EOIR) regulations to eliminate the categorical exception from expedited removal proceedings for Cuban nationals who arrive in the United States at a port of entry by aircraft. This final rule conforms with a parallel Department of Homeland Security (DHS) regulation. As a result of these changes, Cuban nationals who arrive in the United States at a port of entry by aircraft will be subject to expedited removal proceedings commensurate with nationals of other countries.
This final rule is effective January 13, 2017. Interested persons are invited to submit written comments on this final rule on or before March 20, 2017. Comments received by mail will be considered timely if they are postmarked on or before that date. The electronic Federal Docket Management System (FDMS) will accept comments until midnight Eastern Time at the end of that day.
Please submit written comments to Jean King, General Counsel, Executive Office for Immigration Review, 5107 Leesburg Pike, Suite 2600, Falls Church, Virginia 22041. To ensure proper handling, please reference RIN No. 1125-AA80 or EOIR Docket No. 401 on your correspondence. You may submit comments electronically or view an electronic version of this proposed rule at
Jean King, General Counsel, Executive Office for Immigration Review, 5107 Leesburg Pike, Suite 2600, Falls Church, Virginia 22041; telephone (703) 605-1744 (not a toll-free call).
Interested persons are invited to participate in this rulemaking by submitting written data, views, or arguments on all aspects of this rule. EOIR also invites comments that relate to the economic, environmental, or federalism effects that might result from this rule. To provide the most assistance to EOIR, comments should explain the reason for any recommended change, and should include data, information, or authority that supports such recommended change.
All comments submitted for this rulemaking should include the agency name and RIN 1125-AA80 or EOIR Docket No. 401. Please note that all comments received are considered part of the public record and will be made available for public inspection at
If you want to submit personally identifiable information as part of your comment, but do not want it to be posted online, you must include the phrase “PERSONALLY IDENTIFIABLE INFORMATION” in the first paragraph of your comment and identify what information you want redacted.
If you want to submit confidential business information as part of your comment, but do not want it to be posted online, you must include the phrase “CONFIDENTIAL BUSINESS INFORMATION” in the first paragraph of your comment. You also must prominently identify confidential
Personally identifiable information and confidential business information provided as set forth above will be placed in the agency's public docket file, but not posted online. To inspect the agency's public docket file in person, you must make an appointment with agency counsel. Please see the
This rule conforms to the rule published by DHS in this issue of the
The implementation of this rule as a final rule, with provisions for post-promulgation public comments, is based on the good cause exception found in section 553 of the Administrative Procedure Act (APA) (5 U.S.C. 553(b)(B)). Delaying the implementation of the change announced in this rule to allow pre-promulgation notice and comment would be impracticable and contrary to the public interest. Section 235(b)(1)(A)(iii)(I) of the Immigration and Nationality Act explicitly authorizes the Secretary of Homeland Security to designate categories of aliens to whom expedited removal proceedings may be applied, and makes clear that “[s]uch designation shall be in the sole and unreviewable discretion of the Secretary and may be modified at any time.” 8 U.S.C. 1225(b)(1)(A)(iii)(I). This conforming rule is necessary to conform to the DHS rulemaking, which will allow DHS to remove quickly from the United States certain Cuban nationals who arrive by air at U.S. ports of entry. The ability to detain such aliens while admissibility and identity are determined and protection claims are adjudicated, as well as to quickly remove those without protection claims or claims to lawful status, is a necessity for national security and public safety.
Pre-promulgation notice and comment would undermine these interests, while endangering human life and having a potential destabilizing effect in the region. Specifically, the Department is concerned that publication of the rule as a proposed rule, which would signal a significant change in policy while permitting continuation of the exception for Cuban nationals, could lead to a surge in migration of Cuban nationals seeking to travel to and enter the United States during the period between the publication of a proposed and a final rule. Such a surge would threaten national security and public safety by diverting valuable Government resources from counterterrorism and homeland security responsibilities. A surge could also have a destabilizing effect on the region, thus weakening the security of the United States and threatening its international relations. Additionally, a surge could result in significant loss of human life.
Accordingly, DOJ finds that it would be impracticable and contrary to the public interest to accept pre-promulgation comments on this rule. For the same reasons, DOJ also finds good cause to issue this rule without a 30-day delayed effective date requirement of the APA,
In addition, the change implemented by this rule is part of a major foreign policy initiative announced by the President, and is central to ongoing diplomatic discussions between the United States and Cuba with respect to travel and migration between the two countries. DOJ, in consultation with the Department of State, has determined that eliminating the exception from expedited removal proceedings for Cuban nationals involves a foreign affairs function of the United States, 5 U.S.C. 553(a)(1), and is also exempt from the notice and comment and 30-day delayed effective date requirements of the APA on that basis. DOJ is nevertheless providing the opportunity for the public to provide comments.
Executive Orders 13563 and 12866 direct agencies to assess the costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, distributive impacts, and equity). Executive Order 13563 emphasizes the importance of quantifying both costs and benefits, of reducing costs, of harmonizing rules, and of promoting flexibility.
The Office of Management and Budget has not designated this rule as a significant regulatory action under section 3(f) of Executive Order 12866. Accordingly, the Office of Management and Budget has not reviewed this rule.
The Regulatory Flexibility Act (5 U.S.C. 601
This rule will not result in the expenditure by State, local, and tribal governments, in the aggregate, or by the private sector, of $100 million or more in any one year, and it will not significantly or uniquely affect small governments. Therefore, no actions were deemed necessary under the provisions
This rule is not a major rule as defined by section 251 of the Small Business Regulatory Enforcement Fairness Act of 1996.
This rule will not have substantial direct effects on the States, on the relationship between the National Government and the States, or on the distribution of power and responsibilities among the various levels of government. Therefore, in accordance with section 6 of Executive Order 13132, it is determined that this rule does not have sufficient federalism implications to warrant the preparation of a federalism summary impact statement.
This rule meets the applicable standards set forth in sections 3(a) and 3(b)(2) of Executive Order 12988.
The provisions of the Paperwork Reduction Act of 1995, Public Law 104-13, 44 U.S.C. chapter 35, and its implementing regulations, 5 CFR part 1320, do not apply to this rule because there are no new or revised recordkeeping or reporting requirements.
Administrative practice and procedure, Aliens, Immigration, Reporting and recordkeeping requirements.
Accordingly, for the reasons stated in the preamble, part 1235 of title 8 of the Code of Federal Regulations is amended as follows:
8 U.S.C. 1101 and note, 1103, 1183, 1185 (pursuant to E.O. 13323, 69 FR 241, 3 CFR, 2003 Comp., p. 278), 1201, 1224, 1225, 1226, 1228, 1365a note, 1379, 1731-32; Title VII of Public Law 110-229; 8 U.S.C. 1185 note (section 7209 of Pub. L. 108-458).
(b) * * *
(1) * * *
(i) Arriving aliens, as defined in § 1001.1(q) of this chapter;
Federal Aviation Administration (FAA), Department of Transportation (DOT).
Final rule.
We are adopting a new airworthiness directive (AD) for certain Airbus Model A319-115, A319-132, A320-214, A320-232, A321-211, A321-213, and A321-231 airplanes. This AD was prompted by a report of certain tie rod assemblies installed on the hinged fairing assembly of the main landing gear (MLG) with no cadmium plating on the rod end threads. This AD requires inspection and replacement of certain tie rod assemblies installed on the hinged fairing assembly of the MLG. We are issuing this AD to address the unsafe condition on these products.
This AD is effective February 21, 2017.
The Director of the Federal Register approved the incorporation by reference of a certain publication listed in this AD as of February 21, 2017.
For service information identified in this final rule, contact Airbus, Airworthiness Office—EIAS, 1 Rond Point Maurice Bellonte, 31707 Blagnac Cedex, France; telephone +33 5 61 93 36 96; fax +33 5 61 93 44 51; email
You may examine the AD docket on the Internet at
Sanjay Ralhan, Aerospace Engineer, International Branch, ANM-116, Transport Airplane Directorate, FAA, 1601 Lind Avenue SW., Renton, WA 98057-3356; telephone 425-227-1405; fax 425-227-1149.
We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR part 39 by adding an AD that would apply to certain Airbus Model A319-115, A319-132, A320-214, A320-232, A321-211, A321-213, and A321-231 airplanes. The NPRM published in the
The European Aviation Safety Agency (EASA), which is the Technical Agent for the Member States of the European Union, has issued EASA Airworthiness Directive 2015-0234, dated December 8, 2015 (referred to after this as the Mandatory Continuing Airworthiness Information, or “the MCAI”), to correct an unsafe condition for certain Airbus Model A319-115, A319-132, A320-214, A320-232, A321-211, A321-213, and A321-231 airplanes. The MCAI states:
A production quality issue was identified concerning tie rod assemblies, having Part Number (P/N) starting with D52840212000 or D52840212002, which are installed on the main landing gear (MLG) hinged fairing assembly. This quality issue affects the cadmium plating surface treatment which
This condition, if not detected and corrected, could lead to galvanic corrosion of the tie rod end threads, possibly resulting in rod end failure, loss of a MLG door, and consequent injury to persons on ground.
To address this unsafe condition, Airbus identified the affected [manufacturer serial number] MSN and issued [service bulletin] SB A320-52-1167 to provide inspection instructions.
For the reason described above, this [EASA] AD requires a one-time inspection of the affected MLG hinged fairing tie rod assemblies [for the presence of cadmium plating], and, depending on findings, replacement of the affected tie rod assembly.
You may examine the MCAI in the AD docket on the Internet at
We gave the public the opportunity to participate in developing this AD. We received no comments on the NPRM or on the determination of the cost to the public.
We reviewed the relevant data and determined that air safety and the public interest require adopting this AD as proposed except for minor editorial changes. We have determined that these minor changes:
• Are consistent with the intent that was proposed in the NPRM for correcting the unsafe condition; and
• Do not add any additional burden upon the public than was already proposed in the NPRM.
Airbus has issued Service Bulletin A320-52-1167, dated August 6, 2015. The service information describes procedures for a detailed inspection for the presence of cadmium plating on tie rod assemblies having certain part numbers, and procedures for replacement of tie rod assemblies with no cadmium plating on the rod end threads. This service information is reasonably available because the interested parties have access to it through their normal course of business or by the means identified in the
We estimate that this AD affects 20 airplanes of U.S. registry.
We estimate the following costs to comply with this AD:
We estimate the following costs to do any necessary replacements that will be required based on the results of the inspection. We have no way of determining the number of airplanes that might need these replacements:
According to the manufacturer, some of the costs of this AD may be covered under warranty, thereby reducing the cost impact on affected individuals. We do not control warranty coverage for affected individuals. As a result, we have included all available costs in our cost estimate.
Title 49 of the United States Code specifies the FAA's authority to issue rules on aviation safety. Subtitle I, section 106, describes the authority of the FAA Administrator. “Subtitle VII: Aviation Programs,” describes in more detail the scope of the Agency's authority.
We are issuing this rulemaking under the authority described in “Subtitle VII, Part A, Subpart III, Section 44701: General requirements.” Under that section, Congress charges the FAA with promoting safe flight of civil aircraft in air commerce by prescribing regulations for practices, methods, and procedures the Administrator finds necessary for safety in air commerce. This regulation is within the scope of that authority because it addresses an unsafe condition that is likely to exist or develop on products identified in this rulemaking action.
We determined that this AD will not have federalism implications under Executive Order 13132. This AD will not have a substantial direct effect on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government.
For the reasons discussed above, I certify that this AD:
1. Is not a “significant regulatory action” under Executive Order 12866;
2. Is not a “significant rule” under the DOT Regulatory Policies and Procedures (44 FR 11034, February 26, 1979);
3. Will not affect intrastate aviation in Alaska; and
4. Will not have a significant economic impact, positive or negative, on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.
Air transportation, Aircraft, Aviation safety, Incorporation by reference, Safety.
Accordingly, under the authority delegated to me by the Administrator, the FAA amends 14 CFR part 39 as follows:
49 U.S.C. 106(g), 40113, 44701.
This AD is effective February 21, 2017.
None.
This AD applies to Airbus Model A319-115, A319-132, A320-214, A320-232, A321-211, A321-213, and A321-231 airplanes, certificated in any category, as identified in Airbus Service Bulletin A320-52-1167, dated August 6, 2015.
Air Transport Association (ATA) of America Code 52, Doors.
This AD was prompted by a report of certain tie rod assemblies installed on the hinged fairing assembly of the main landing gear (MLG) with no cadmium plating on the rod end threads. We are issuing this AD to detect and correct the absence of cadmium plating on the rod end threads of the tie rod assemblies. The absence of cadmium plating could lead to galvanic corrosion of the tie rod end threads, resulting in rod end failure, loss of a MLG door, and consequent damage to the airplane.
Comply with this AD within the compliance times specified, unless already done.
Within 80 months after the airplane's first flight, do a detailed inspection of each tie rod assembly having a part number (P/N) D52840212000 or D52840212002 at the MLG hinged fairing for the presence of cadmium plating (gold colored threads), in accordance with the Accomplishment Instructions of Airbus Service Bulletin A320-52-1167, dated August 6, 2015. If during the inspection any tie rod assembly is found that does not have cadmium plating, before further flight, replace the tie rod assembly with a serviceable part having the same part number and cadmium plating, in accordance with the Accomplishment Instructions of Airbus Service Bulletin A320-52-1167, dated August 6, 2015.
The following provisions also apply to this AD:
(1)
(2)
(3)
Refer to Mandatory Continuing Airworthiness Information (MCAI) EASA Airworthiness Directive 2015-0234, dated December 8, 2015, for related information. This MCAI may be found in the AD docket on the Internet at
(1) The Director of the Federal Register approved the incorporation by reference (IBR) of the service information listed in this paragraph under 5 U.S.C. 552(a) and 1 CFR part 51.
(2) You must use this service information as applicable to do the actions required by this AD, unless this AD specifies otherwise.
(i) Airbus Service Bulletin A320-52-1167, dated August 6, 2015.
(ii) Reserved.
(3) For service information identified in this AD, contact Airbus, Airworthiness Office—EIAS, 1 Rond Point Maurice Bellonte, 31707 Blagnac Cedex, France; telephone +33 5 61 93 36 96; fax +33 5 61 93 44 51; email
(4) You may view this service information at the FAA, Transport Airplane Directorate, 1601 Lind Avenue SW., Renton, WA. For information on the availability of this material at the FAA, call 425-227-1221.
(5) You may view this service information that is incorporated by reference at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to:
Federal Aviation Administration (FAA), DOT.
Final rule.
We are adopting a new airworthiness directive (AD) for certain The Boeing Company Model 787-8 and 787-9 airplanes. This AD was prompted by a report that some inboard and outboard trailing edge flap rotary actuators may have been assembled with an incorrect no-back brake rotor-stator stack sequence during manufacturing. This AD requires inspecting the trailing edge flap rotary actuator, and replacing the rotary actuator or doing related investigative and corrective actions if necessary. We are issuing this AD to address the unsafe condition on these products.
This AD is effective February 21, 2017.
The Director of the Federal Register approved the incorporation by reference of a certain publication listed in this AD as of February 21, 2017.
For service information identified in this final rule, contact Boeing Commercial Airplanes, Attention: Contractual & Data Services (C&DS), 2600 Westminster Blvd., MC
You may examine the AD docket on the Internet at
Fnu Winarto, Aerospace Engineer, Systems and Equipment Branch, ANM-130S, FAA, Seattle Aircraft Certification Office (ACO), 1601 Lind Avenue SW., Renton, WA 98057-3356; phone: 425-917-6659; fax: 425-917-6590; email:
We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR part 39 by adding an AD that would apply to certain The Boeing Company Model 787-8 and 787-9 airplanes. The NPRM published in the
We gave the public the opportunity to participate in developing this AD. The following presents the comments received on the NPRM and the FAA's response. Boeing stated that it supported the NPRM. United Airlines (UAL) stated that it supported the compliance time in the NPRM.
UAL requested that Boeing re-evaluate its warranty policy. UAL stated that an incorrect stack sequence occurred during the manufacturing process and that operators should not be penalized for having to perform the test and replacement of the rotary actuators.
We partially agree with the request. We agree that this is a manufacturing issue. However, we have not revised this final rule in this regard because we do not regulate Boeing's warranty policy.
We reviewed the relevant data, considered the comments received, and determined that air safety and the public interest require adopting this AD as proposed, except for minor editorial changes. We have determined that these minor changes:
• Are consistent with the intent that was proposed in the NPRM for correcting the unsafe condition; and
• Do not add any additional burden upon the public than was already proposed in the NPRM.
We reviewed Boeing Alert Service Bulletin B787-81205-SB270032-00, Issue 001, dated November 3, 2015. The service information describes procedures for an inspection of the inboard and outboard flap rotary actuator for any discrepant rotary actuator, and procedures for replacing the rotary actuator, or determining the flight cycles on the rotary actuator and doing applicable related investigative and corrective actions. This service information is reasonably available because the interested parties have access to it through their normal course of business or by the means identified in the
We estimate that this AD affects 5 airplanes of U.S. registry.
We estimate the following costs to comply with this AD:
We estimate the following costs to do any necessary on-condition actions that will be required based on the results of the inspection. We have no way of determining the number of aircraft that might need this replacement:
Title 49 of the United States Code specifies the FAA's authority to issue rules on aviation safety. Subtitle I, section 106, describes the authority of the FAA Administrator. Subtitle VII: Aviation Programs, describes in more detail the scope of the Agency's authority.
We are issuing this rulemaking under the authority described in Subtitle VII, Part A, Subpart III, Section 44701: “General requirements.” Under that section, Congress charges the FAA with promoting safe flight of civil aircraft in air commerce by prescribing regulations for practices, methods, and procedures the Administrator finds necessary for safety in air commerce. This regulation is within the scope of that authority because it addresses an unsafe condition that is likely to exist or develop on products identified in this rulemaking action.
This AD will not have federalism implications under Executive Order 13132. This AD will not have a substantial direct effect on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government.
For the reasons discussed above, I certify that this AD:
(1) Is not a “significant regulatory action” under Executive Order 12866,
(2) Is not a “significant rule” under DOT Regulatory Policies and Procedures (44 FR 11034, February 26, 1979),
(3) Will not affect intrastate aviation in Alaska, and
(4) Will not have a significant economic impact, positive or negative, on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.
Air transportation, Aircraft, Aviation safety, Incorporation by reference, Safety.
Accordingly, under the authority delegated to me by the Administrator, the FAA amends 14 CFR part 39 as follows:
49 U.S.C. 106(g), 40113, 44701.
This AD is effective February 21, 2017.
None.
This AD applies to The Boeing Company Model 787-8 and 787-9 airplanes, certificated in any category, as identified in Boeing Alert Service Bulletin B787-81205-SB270032-00, Issue 001, dated November 3, 2015.
Air Transport Association (ATA) of America Code 27, Flight Control Systems.
This AD was prompted by a report that some inboard and outboard trailing edge flap rotary actuators may have been assembled with an incorrect no-back brake rotor-stator stack sequence during manufacturing. We are issuing this AD to detect and replace rotary actuators having incorrect assembly, which could cause accelerated unit wear that will eventually reduce braking performance. This degradation could lead to loss of no-back brake function and reduced controllability of the airplane.
Comply with this AD within the compliance times specified, unless already done.
Within 60 months after the effective date of this AD, do an inspection of the inboard and outboard trailing edge flap rotary actuator for any discrepant rotary actuator, in accordance with the Accomplishment Instructions of Boeing Alert Service Bulletin B787-81205-SB270032-00, Issue 001, dated November 3, 2015. If any discrepant rotary actuator is found, within 60 months after the effective date of this AD, do the actions specified in paragraph (g)(1) or (g)(2) of this AD, in accordance with the Accomplishment Instructions of Boeing Alert Service Bulletin B787-81205-SB270032-00, Issue 001, dated November 3, 2015.
(1) Replace the discrepant rotary actuator.
(2) Check the maintenance records to determine the flight cycles of each discrepant rotary actuator and, within 60 months after the effective date of this AD, do all applicable related investigative and corrective actions.
(1) The Manager, Seattle Aircraft Certification Office (ACO), FAA, has the authority to approve AMOCs for this AD, if requested using the procedures found in 14 CFR 39.19. In accordance with 14 CFR 39.19, send your request to your principal inspector or local Flight Standards District Office, as appropriate. If sending information directly to the manager of the ACO, send it to the attention of the person identified in paragraph (i) of this AD. Information may be emailed to:
(2) Before using any approved AMOC, notify your appropriate principal inspector, or lacking a principal inspector, the manager of the local flight standards district office/certificate holding district office.
(3) An AMOC that provides an acceptable level of safety may be used for any repair required by this AD if it is approved by the Boeing Commercial Airplanes Organization Designation Authorization (ODA) that has been authorized by the Manager, Seattle ACO to make those findings. To be approved, the repair method, modification deviation, or alteration deviation must meet the certification basis of the airplane, and the approval must specifically refer to this AD.
(4) For service information that contains steps that are labeled as Required for Compliance (RC), the provisions of paragraphs (h)(4)(i) and (h)(4)(ii) of this AD apply.
(i) The steps labeled as RC, including substeps under an RC step and any figures identified in an RC step, must be done to comply with the AD. If a step or substep is labeled “RC Exempt,” then the RC requirement is removed from that step or substep. An AMOC is required for any deviations to RC steps, including substeps and identified figures.
(ii) Steps not labeled as RC may be deviated from using accepted methods in accordance with the operator's maintenance or inspection program without obtaining approval of an AMOC, provided the RC steps, including substeps and identified figures, can still be done as specified, and the airplane can be put back in an airworthy condition.
For more information about this AD, contact Fnu Winarto, Aerospace Engineer, Systems and Equipment Branch, ANM-130S, FAA, Seattle ACO, 1601 Lind Avenue SW., Renton, WA 98057-3356; phone: 425-917-6659; fax: 425-917-6590; email:
(1) The Director of the Federal Register approved the incorporation by reference (IBR) of the service information listed in this paragraph under 5 U.S.C. 552(a) and 1 CFR part 51.
(2) You must use this service information as applicable to do the actions required by this AD, unless the AD specifies otherwise.
(i) Boeing Alert Service Bulletin B787-81205-SB270032-00, Issue 001, dated November 3, 2015.
(ii) Reserved.
(3) For service information identified in this AD, contact Boeing Commercial Airplanes, Attention: Contractual & Data Services (C&DS), 2600 Westminster Blvd., MC 110-SK57, Seal Beach, CA 90740-5600; telephone 562-797-1717; Internet
(4) You may view this referenced service information at the FAA, Transport Airplane Directorate, 1601 Lind Avenue SW., Renton, WA. For information on the availability of this material at the FAA, call 425 227-1221.
(5) You may view this service information that is incorporated by reference at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to:
Federal Aviation Administration (FAA), DOT.
Final rule.
We are adopting a new airworthiness directive (AD) for certain The Boeing Company Model 767-300 and 767-300F series airplanes. This AD was prompted by reports of malfunctions in the flight deck display units, which resulted in blanking, blurring, or loss of color on the display. This AD requires modification and installation of components in the main equipment center. For certain other airplanes this AD requires modification, replacement, and installation of flight deck air relief system (FDARS) components. We are issuing this AD to address the unsafe condition on these products.
This AD is effective February 21, 2017.
The Director of the Federal Register approved the incorporation by reference of certain publications listed in this AD as of February 21, 2017.
For service information identified in this final rule, contact Boeing Commercial Airplanes, Attention: Contractual & Data Services (C&DS), 2600 Westminster Blvd., MC 110-SK57, Seal Beach, CA 90740-5600; telephone: 562-797-1717; Internet:
You may examine the AD docket on the Internet at
Francis Smith, Aerospace Engineer, Cabin Safety and Environmental Controls Branch, ANM-150S, FAA, Seattle Aircraft Certification Office (ACO), 1601 Lind Avenue SW., Renton, WA 98057-3356; phone: 425-917-6596; fax: 425-917-6590; email:
We issued a supplemental notice of proposed rulemaking (SNPRM) to amend 14 CFR part 39 by adding an AD that would apply to certain The Boeing Company Model 767-300 and 767-300F series airplanes. The SNPRM published in the
We gave the public the opportunity to participate in developing this AD. The following presents the comments received on the SNPRM and the FAA's response to each comment.
The Air Line Pilots Association, International supported the intent of the SNPRM.
Aviation Partners Boeing stated that the installation of winglets per Supplemental Type Certificate (STC) ST01920SE does not affect the accomplishment of the manufacturer's service instructions.
We agree with the commenter that STC ST01920SE does not affect the accomplishment of the manufacturer's service instructions. Therefore, the installation of STC ST01920SE does not affect the ability to accomplish the actions required by this AD. We have not changed this final rule in this regard.
We reviewed the relevant data, considered the comments received, and determined that air safety and the public interest require adopting this AD as proposed, except for minor editorial changes. We have determined that these minor changes:
• Are consistent with the intent that was proposed in the SNPRM for correcting the unsafe condition; and
• Do not add any additional burden upon the public than was already proposed in the SNPRM.
We reviewed the following service information.
• Boeing Service Bulletin 767-21-0235, dated October 8, 2009; and Revision 1, dated July 29, 2011 (“SB 767-21-0235, R1”). The service information describes procedures for a relay installation and related wiring changes (which change (modify) the 3-way valve control logic for the cooling system for the flight deck display equipment on freighter airplanes).
• Boeing Service Bulletin 767-21-0244, Revision 1, dated March 8, 2010 (“SB 767-27-0244, R1”). The service information describes procedures for changing (modifying) the 3-way valve control logic and installing a cooling system for the flight deck display equipment.
• Boeing Alert Service Bulletin 767-21A0245, Revision 2, dated September 27, 2013 (“ASB 767-21A0245, R2”); and Boeing Alert Service Bulletin 767-21A0247, Revision 1, dated April 9, 2013 (“ASB 767-21A0247, R1”). The service information describes procedures for changing (modifying) the 3-way valve control logic and main cargo air distribution system (MCADS), and installing an FDARS. These documents are distinct since they apply to different airplane models.
• Boeing Alert Service Bulletin 767-21A0253, dated October 12, 2012. The service information describes procedures for replacing the existing duct, installing an FDARS, changing (modifying) the 3-way valve control logic, and installing a new altitude switch and pitot tube.
• Boeing Alert Service Bulletin 767-21A0254, dated June 7, 2013. The service information describes procedures for replacing the duct with a new duct; installing an FDARS (including the installation of mounting brackets, ducts, orifice, outlet valve, and screen); and activating the 3-way valve logic (including modification of the associated wiring and related actions).
• Boeing Service Bulletin 767-31-0073, dated October 12, 1995. The service information describes procedures for installing a maintenance data selection system for the engine indication and crew alerting system.
This service information is reasonably available because the interested parties have access to it through their normal course of business or by the means identified in the
We estimate that this AD affects 52 airplanes of U.S. registry.
We estimate the following costs to comply with this AD:
According to the manufacturer, some of the costs of this AD may be covered under warranty, thereby reducing the cost impact on affected individuals. We do not control warranty coverage for affected individuals. As a result, we have included all costs in our cost estimate.
Title 49 of the United States Code specifies the FAA's authority to issue rules on aviation safety. Subtitle I, section 106, describes the authority of the FAA Administrator. Subtitle VII: Aviation Programs, describes in more detail the scope of the Agency's authority.
We are issuing this rulemaking under the authority described in Subtitle VII, Part A, Subpart III, Section 44701: “General requirements.” Under that section, Congress charges the FAA with promoting safe flight of civil aircraft in air commerce by prescribing regulations for practices, methods, and procedures the Administrator finds necessary for safety in air commerce. This regulation is within the scope of that authority because it addresses an unsafe condition that is likely to exist or develop on products identified in this rulemaking action.
This AD will not have federalism implications under Executive Order 13132. This AD will not have a substantial direct effect on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government.
For the reasons discussed above, I certify that this AD:
(1) Is not a “significant regulatory action” under Executive Order 12866,
(2) Is not a “significant rule” under DOT Regulatory Policies and Procedures (44 FR 11034, February 26, 1979),
(3) Will not affect intrastate aviation in Alaska, and
(4) Will not have a significant economic impact, positive or negative, on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.
Air transportation, Aircraft, Aviation safety, Incorporation by reference, Safety.
Accordingly, under the authority delegated to me by the Administrator, the FAA amends 14 CFR part 39 as follows:
49 U.S.C. 106(g), 40113, 44701.
This AD is effective February 21, 2017.
None.
This AD applies to The Boeing Company Model 767-300 and 767-300F series airplanes, certificated in any category; as identified in the service information specified in paragraphs (c)(1) through (c)(5) of this AD. This AD does not apply to The Boeing Company Model 767-300 (passenger) series airplanes.
(1) Boeing Service Bulletin 767-21-0244, Revision 1, dated March 8, 2010 (“SB 767-27-0244, R1”).
(2) Boeing Alert Service Bulletin 767-21A0245, Revision 2, dated September 27, 2013 (“ASB 767-21A0245, R2”).
(3) Boeing Alert Service Bulletin 767-21A0247, Revision 1, dated April 9, 2013 (“ASB 767-21A0247, R1”).
(4) Boeing Alert Service Bulletin 767-21A0253, dated October 12, 2012.
(5) Boeing Alert Service Bulletin 767-21A0254, dated June 7, 2013.
Air Transport Association (ATA) of America Code 21, Air Conditioning.
This AD was prompted by reports of malfunctions in the flight deck display units, which resulted in blanking, blurring, or loss of color on the display. We are issuing this AD to prevent malfunctions of the flight deck display units, which could affect the ability of the flight crew to read the displays for airplane attitude, altitude, or airspeed, and consequently reduce the ability of the flight crew to maintain control of the airplane.
Comply with this AD within the compliance times specified, unless already done.
(1) For Model 767-300F series airplanes, as identified in Boeing Alert Service Bulletin 767-21A0253, dated October 12, 2012: Within 72 months after the effective date of this AD, in the main equipment center and the area under the left and right sides of the flight deck floor, replace the existing duct with a new duct; install an FDARS (including the installation of mounting brackets, ducts, orifice, outlet valve, and screen); change the 3-way valve logic (including modification of the associated wiring and related actions); and install a new altitude switch and pitot tube; in accordance with the Accomplishment Instructions of Boeing Alert Service Bulletin 767-21A0253, dated October 12, 2012.
(2) For Model 767-300F series airplanes, as identified in Boeing Alert Service Bulletin 767-21A0254, dated June 7, 2013: Within 72 months after the effective date of this AD, in the main equipment center and the area under the left and right sides of the flight deck floor, replace the duct with a new duct; install an FDARS (including the installation of mounting brackets, ducts, orifice, outlet valve, and screen); and activate the 3-way valve logic (including modification of the associated wiring and related actions); in accordance with the Accomplishment Instructions of Boeing Alert Service Bulletin 767-21A0254, dated June 7, 2013.
(1) For Model 767-300F series airplanes, as identified in ASB 767-21A0245, R2: Within 72 months after the effective date of this AD, in the main equipment center and the area under the left and right sides of the flight deck floor, change (modify) the 3-way valve control logic and main cargo air distribution system (MCADS), and install an FDARS, in accordance with the Accomplishment Instruction of ASB 767-21A0245, R2, except as provided by paragraph (j) of this AD.
(2) For Model 767-300F series airplanes, as identified in ASB 767-21A0247, R1: Within 72 months after the effective date of this AD, change (modify) the 3-way valve control logic and MCADS, and install an FDARS, in accordance with the Accomplishment Instructions of ASB 767-21A0247, R1.
For Model 767-300 series airplanes that have been converted by Boeing to Model 767-300BCF (Boeing Converted Freighter) airplanes, as identified in SB 767-27-0244, R1: Within 72 months after the effective date of this AD, change (modify) the 3-way valve control logic and install a flight deck display equipment cooling system, in accordance with the Accomplishment Instructions of SB 767-27-0244, R1.
For Model 767-300F series airplanes, as identified in ASB 767-21A0245, R2: If the 3 way valve control logic change (modification) specified in Boeing Service Bulletin 767-21-0235, dated October 8, 2009; or Revision 1, dated July 29, 2011 (“SB 767-21-0235, R1”); is done prior to or concurrent with the actions required by paragraph (h)(1) of this AD, operators need to do only the functional test, FDARS installation, and flex duct change, in accordance with the Accomplishment Instructions of ASB 767-21A0245, R2. Operators do not need to do the other actions specified in the Accomplishment Instructions of ASB 767-21A0245, R2, if the actions in the Accomplishment Instructions of Boeing Service Bulletin 767-21-0235, dated October 8, 2009; or SB 767-21-0235, R1; are done concurrently. If the functional test fails, before further flight, do corrective actions that are approved in accordance with the procedures specified in paragraph (l) of this AD.
(1) For Groups 1 and 3 airplanes, as identified in ASB 767-21A0245, R2: Prior to or concurrently with accomplishing the requirements of paragraph (h)(1) of this AD, do the relay installation and related wiring changes specified in, and in accordance with, the Accomplishment Instructions of Boeing Service Bulletin 767-21-0235, dated October 8, 2009; or SB 767-21-0235, R1.
(2) For Group 1 airplanes, as identified in ASB 767-21A0247, R1: Prior to or concurrently with accomplishing the requirements of paragraph (h)(2) of this AD, do the relay installation and related wiring changes specified in the Accomplishment Instructions of Boeing Service Bulletin 767-21-0235, dated October 8, 2009; or SB 767-21-0235, R1.
(3) For Model 767-300 series airplanes that have been converted by Boeing to Model 767-300BCF airplanes, as identified in SB 767-27-0244, R1: Prior to or concurrently with accomplishing the requirements of paragraph (i) of this AD, do all the actions (installation) specified in the Accomplishment Instructions of Boeing Service Bulletin 767-31-0073, dated October 12, 1995.
(1) The Manager, Seattle Aircraft Certification Office (ACO), FAA, has the authority to approve AMOCs for this AD, if requested using the procedures found in 14 CFR 39.19. In accordance with 14 CFR 39.19, send your request to your principal inspector or local Flight Standards District Office, as appropriate. If sending information directly to the manager of the ACO, send it to the attention of the person identified in paragraph (m) of this AD. Information may be
(2) Before using any approved AMOC, notify your appropriate principal inspector, or lacking a principal inspector, the manager of the local flight standards district office/certificate holding district office.
(3) An AMOC that provides an acceptable level of safety may be used for any repair, modification, or alteration required by this AD if it is approved by the Boeing Commercial Airplanes Organization Designation Authorization (ODA) that has been authorized by the Manager, Seattle ACO, to make those findings. To be approved, the repair method, modification deviation, or alteration deviation must meet the certification basis of the airplane and the approval must specifically refer to this AD.
For more information about this AD, contact Francis Smith, Aerospace Engineer, Cabin Safety and Environmental Controls Branch, ANM-150S, FAA, Seattle ACO, 1601 Lind Avenue SW., Renton, WA 98057-3356; phone: 425-917-6596; fax: 425-917-6590; email:
(1) The Director of the Federal Register approved the incorporation by reference (IBR) of the service information listed in this paragraph under 5 U.S.C. 552(a) and 1 CFR part 51.
(2) You must use this service information as applicable to do the actions required by this AD, unless the AD specifies otherwise.
(i) Boeing Service Bulletin 767-21-0235, dated October 8, 2009.
(ii) Boeing Service Bulletin 767-21-0235, Revision 1, dated July 29, 2011.
(iii) Boeing Service Bulletin 767-21-0244, Revision 1, dated March 8, 2010.
(iv) Boeing Alert Service Bulletin 767-21A0245, Revision 2, dated September 27, 2013.
(v) Boeing Alert Service Bulletin 767-21A0247, Revision 1, dated April 9, 2013.
(vi) Boeing Alert Service Bulletin 767-21A0253, dated October 12, 2012.
(vii) Boeing Alert Service Bulletin 767-21A0254, dated June 7, 2013.
(viii) Boeing Service Bulletin 767-31-0073, dated October 12, 1995.
(3) For service information identified in this AD, contact Boeing Commercial Airplanes, Attention: Contractual & Data Services (C&DS), 2600 Westminster Blvd., MC 110-SK57, Seal Beach, CA 90740-5600; telephone: 562-797-1717; Internet:
(4) You may view this service information at the FAA, Transport Airplane Directorate, 1601 Lind Avenue SW., Renton, WA. For information on the availability of this material at the FAA, call 425-227-1221.
(5) You may view this service information that is incorporated by reference at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to:
Bureau of Industry and Security, Commerce.
Final rule.
This rule revises the policy of review for applications for licenses to export or reexport to Sudan certain items that are intended to ensure the safety of civil aviation or the safe operation of fixed-wing, commercial passenger aircraft. Such applications will now be reviewed under a general policy of approval rather than a general policy of denial.
This rule also revises the review policy from a general policy of denial to a general policy of approval for applications for licenses to export or reexport to Sudan certain items for use to inspect, design, construct, operate, improve, maintain, repair, overhaul or refurbish railroads in Sudan. This rule does not create any new license requirements or remove any existing license requirements for exports or reexports to Sudan. BIS is making these licensing policy changes in connection with ongoing U.S.-Sudan bilateral engagement, and with the aim of enhancing the safety of Sudan's civil aviation and improving the country's railroads. This action takes into account the United States' goals to improve regional peace and security.
This rule also removes two instances of “contract sanctity dates” pertaining to the export and reexport of certain items to Sudan from the EAR that currently serve no practical purpose.
BIS is taking these actions in coordination with the Department of the Treasury's Office of Foreign Assets Control (OFAC), which is amending the Sudanese Sanctions Regulations.
Foreign Policy Division, Bureau of Industry and Security, Phone: (202) 482-4252.
Pursuant to § 742.10 of the Export Administration Regulations (EAR), in keeping with Sudan's designation as a state sponsor of terrorism, persons must obtain a license to export or reexport to Sudan all aircraft controlled on the Commerce Control List (Supp. No. 1 to part 774 of the EAR) (CCL) and to export related parts and components that are controlled on the CCL. Prior to the publication of this rule, the EAR imposed a general policy of denial on license applications for such exports or reexports to all end-users and for all end uses in Sudan. This rule revises the licensing policy to a general policy of approval for parts, components, materials, equipment, and technology that are controlled on the CCL only for anti-terrorism reasons and that are intended to ensure the safety of civil aviation or the safe operation of fixed-wing, commercial passenger aircraft.
Applications to export or reexport to Sudan complete aircraft and applications to export or reexport to Sudan aircraft-related items that are controlled for anti-terrorism reasons and one or more additional reasons (for example, missile technology reasons) will continue to be reviewed under a general policy of denial to all end users.
This rule also revises the general policy of denial to a general policy of approval for license applications to export or reexport to Sudan items controlled on the CCL only for anti-terrorism reasons that will be used to inspect, design, construct, operate, improve, maintain, repair, overhaul or refurbish railroads in Sudan.
With respect to both aircraft related-items and railroad-related items, the general policies of approval set forth in this rule apply only to exports and reexports to Sudan for civil uses by non-sensitive end-users within Sudan. Sensitive end users, who are not eligible for these policies, include Sudan's military, police, and/or intelligence services and persons that are owned by or are part of or are operated or controlled by those services. Additionally, license applications for the export or reexport of items that would substantially benefit such sensitive end users will generally be denied. To implement these policies, this rule revises § 742.10(b)(3) of the EAR, which sets forth exceptions to the general policies of denial that apply to most license applications to export or reexport to Sudan.
In conjunction with this rule, the Department of the Treasury's Office of Foreign Assets Control (OFAC) is
BIS will continue to evaluate license applications in light of section 6(j) of the Export Administration Act of 1979 (EAA), as continued in effect under the International Emergency Economic Powers Act, and any other relevant legal requirements.
This rule also removes and reserves paragraphs (c)(6)(iii) and (c)(10)(iii) of Supplement No. 2 to part 742, which state licensing policy and contract sanctity dates for aircraft, and cryptographic and cryptologic equipment, respectively. The licensing policies for these commodities are stated in paragraphs (b)(1)(iv) and (b)(1)(v) of § 742.10 and need not be repeated in Supplement No. 2. Moreover, as a consequence of this rule, which revises licensing policy for certain aircraft-related items and railroad-related items, the latter category potentially including cryptographic and cryptologic equipment, paragraphs (c)(6)(iii) and (c)(10)(iii)'s statements of a general policy of denial for all end-users in Sudan is no longer accurate. Additionally, the recitation of contract sanctity dates in Supplement No. 2 does not serve a practical purpose. The term “contract sanctity date” draws on section 6(p) of the EAA. That section constrains BIS's ability to limit exports and reexports in performance of contracts entered into prior to the date of imposition of export controls. The references to the contract sanctity dates in the supplement do not limit or otherwise affect the right of any license applicant to assert that the provisions of section 6(p) of the EAA apply to the license application that it is submitting. The identified dates are also long outdated, with March 21, 2003, the most recent contract sanctity date that this rule removes from Supplement No. 2 to part 742.
Although the Export Administration Act of 1979 expired on August 20, 2001, the President, through Executive Order 13222 of August 17, 2001, 3 CFR, 2001 Comp., p. 783 (2002), as amended by Executive Order 13637 of March 8, 2013, 78 FR 16129 (March 13, 2013), and as extended by the Notice of August 4, 2016, 81 FR 52587 (August 8, 2016), has continued the Export Administration Regulations in effect under the International Emergency Economic Powers Act. BIS continues to carry out the provisions of the Export Administration Act, as appropriate and to the extent permitted by law, pursuant to Executive Order 13222 as amended by Executive Order 13637.
1. Executive Orders 13563 and 12866 direct agencies to assess all costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, distributive impacts, and equity). Executive Order 13563 emphasizes the importance of quantifying both costs and benefits, of reducing costs, of harmonizing rules, and of promoting flexibility. This rule has been determined not to be significant for purposes of Executive Order 12866.
2. Notwithstanding any other provision of law, no person is required to respond to, nor shall any person be subject to a penalty for failure to comply with, a collection of information subject to the requirements of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501
3. This rule does not contain policies with Federalism implications as that term is defined under Executive Order 13132.
4. The provisions of the Administrative Procedure Act (5 U.S.C. 553) requiring notice of proposed rulemaking and the opportunity for public participation, and a delay in effective date, are inapplicable because this regulation involves a military or foreign affairs function of the United States (
Further, no other law requires that a notice of proposed rulemaking and an opportunity for public comment be given for this rule. Because a notice of proposed rulemaking and an opportunity for public comment are not required to be given for this rule under 5 U.S.C. 553, or by any other law, the requirements of the Regulatory Flexibility Act (5 U.S.C. 601
Exports, Terrorism.
For the reasons set forth in the preamble, part 742 of the Export Administration Regulations (15 CFR parts 730-774) is amended as follows:
50 U.S.C. 4601
The additions and revisions read as follows:
(b) * * *
(1)
(iv) Except as provided in paragraph (b)(3)(ii) of this section, all aircraft (powered and unpowered), helicopters, engines and related spare parts and components. * * *
(2)
(3)
(i)
(A) The transaction involves the reexport to Sudan of items where Sudan was not the intended ultimate destination at the time of original export from the United States, provided that the export from the United States occurred prior to the applicable contract sanctity date.
(B) The U.S. content of foreign-produced commodities is 20% or less by value.
(C) The commodities are medical items.
(D) The items are telecommunications equipment and associated computers, software and technology for civil end use, including items useful for the development of civil telecommunications network infrastructure.
(ii)
(A) Parts, components, materials, equipment, and technology that are controlled on the Commerce Control List (Supp. No. 1 to part 774 of the EAR) only for anti-terrorism reasons that are intended to ensure the safety of civil aviation or the safe operation of fixed-wing commercial passenger aircraft.
(B) Items controlled on the Commerce Control List (Supp. No. 1 to part 774 of the EAR) only for anti-terrorism reasons that will be used to inspect, design, construct, operate, improve, maintain, repair, overhaul or refurbish railroads in Sudan.
Office of Justice Programs, Department of Justice.
Final rule.
The Office of Juvenile Justice and Delinquency Prevention (“OJJDP”) of the U.S. Department of Justice's Office of Justice Programs (“OJP”), publishes this partial final rule to amend portions of the formula grant program (“Formula Grant Program”) regulation to reflect changes in OJJDP policy.
Gregory Thompson, Senior Advisor, Office of Juvenile Justice and Delinquency Prevention, at 202-307-5911.
The OJJDP Formula Grant Program is authorized by the Juvenile Justice and Delinquency Prevention Act (“JJDPA”). The JJDPA authorizes OJJDP to provide an annual grant to each State to improve its juvenile justice system and to support juvenile delinquency prevention programs. OJJDP published a notice of proposed rulemaking on August 8, 2016, 81 FR 52377, that proposed to revise the entirety of the Formula Grant Program regulation.
OJJDP is finalizing some, but not all, aspects of the proposed rule here. For several provisions, OJJDP has addressed the comments received and is amending the current Formula Grant Program regulation through this partial final rule. For other provisions included in the proposed rule, OJJDP received voluminous comments that will require additional time for OJJDP to consider them thoughtfully. OJJDP anticipates publishing a final rule in the future addressing the remainder of the proposed changes that are not addressed in this partial final rule.
The JJDPA authorizes annual formula grants to be made to States to improve their juvenile justice systems and to support juvenile delinquency prevention programs.
This rule amends the Formula Grant Program regulation in the following respects: (1) It replaces 28 CFR 31.303(f)(6), which provides standards for determining compliance with the
As noted in the preamble to the Notice of Proposed Rulemaking, it is difficult to quantify the financial costs to States of the increased monitoring and reporting requirements, and OJJDP did not receive any comments from States indicating what those increased costs might be. OJJDP expects, however, that those costs will be considerably lower under this partial final rule than they would have been under the proposed rule. For example, under the compliance standards in this partial final rule, only eight States would be out of compliance based on the fiscal year 2013 data, rather than the forty-eight States that would have been out of compliance under the standards in the proposed rule. In addition, in this partial final rule the revised definition of “detain or confine” clarifies, per the statute, that the term does not apply to situations where juveniles are being held solely pending their return to a parent or guardian or pending transfer to the custody of a child welfare or social services agency. Nor (in keeping with the statute) does it apply to situations where juveniles are held in a non-secure area of a building that also houses an adult jail or lockup. OJJDP expects that this clarification, along with the revised definition, will greatly reduce the amount of data that States will have to collect, compared to what they would have had to collect under the proposed definition. Finally, although the proposed rule would have required that 100% of facilities annually report compliance data, this partial final rule provides that States must submit annual compliance data from only 85% of those facilities.
This rule amends the regulation implementing the JJDPA Formula Grant Program at 28 CFR part 31, authorized by 42 U.S.C. 5631(a). This section of the JJDPA authorizes OJJDP to provide an annual grant to each State to improve its juvenile justice system and to support juvenile delinquency prevention programs.
On August 8, 2016, OJP published a Notice of Proposed Rulemaking at 81 FR 52377, seeking comments on a rule that would have superseded the current Formula Grant Program regulation at 28 CFR part 31 in its entirety. The period for commenting on the proposed rule closed on October 7, 2016. During that period, OJJDP received 72 written comments, from a diverse array of respondents, representing State entities that administer the JJDPA, child advocacy organizations, public interest groups, and individuals.
Based on the volume and complexity of the comments received, OJP has decided to publish a partial final rule to implement only some of the provisions included in the proposed rule as amendments to the current regulations. Many of the provisions included in the proposed rule, and responses to comments regarding those provisions, will be addressed in a future final rule, after further consideration.
1. The compliance standards included in section 31.9 of the proposed rule for the DSO, separation, and jail removal requirements have been significantly revised. This rule incorporates the revised language by amending section 31.303(f)(6) of the current regulation, through the adoption of a new methodology for determining the compliance standards on an annual basis.
2. The requirement in section 31.7(d)(1) of the proposed rule that States must annually submit compliance monitoring data from 100% of all facilities that are required to report such data has been modified. This rule amends section 31.303(f)(5) of the current regulations, such that States will be required to report data for 85% of facilities and demonstrate how they would extrapolate and report, in a statistically valid manner, data for the remaining 15% of facilities.
3. Consistent with the requirement in section 31.8(a) of the proposed rule, this rule amends section 31.303(f)(5) of the current regulations to change the compliance data reporting period to the federal fiscal year as required by the Act, at 42 U.S.C. 5633(c).
4. Instead of the proposed annual deadline of January 31st included in section 31.8(b) of the proposed rule for States to submit their compliance monitoring reports, this rule amends section 31.303(f)(5) of the current regulations to change the deadline to February 28th, with a provision allowing the Administrator to grant a one-month extension to March 31st upon a State's showing of good cause.
5. This rule modifies the definition for “detain or confine” included in section 31.2 of the proposed rule. This rule adds this definition in subsection 31.304(q) of the current regulations, and clarifies that it does not apply to juveniles who are being held by law enforcement solely pending their reunification with a parent or guardian or pending transfer to the custody of a child welfare or social services agency.
1. Proposed changes to the Disproportionate Minority Contact (DMC) requirement;
2. Providing definitions for the following terms: “Administrator”, “alien”, “annual performance report”, “assessment”, “authorized representative”, “compliance monitoring report”, “construction fixtures”, “contact between juveniles and adult inmates”, “convicted”, “core requirements”, “designated state agency”, “DMC requirements”, “DSO requirements”, “extended juvenile court jurisdiction”, “full due process rights guaranteed to a status offender by the Constitution of the United States”, “jail removal requirements”, “juvenile”, “juveniles alleged to be or found to be delinquent”, “juveniles who are accused of nonstatus offenses”, “minority groups”, “monitoring universe”, “non-secure facility”, “placed or placement”, “public holidays”, “residential”, “responsible agency official”, “separation requirements”, “status offender”, “status offense”, “twenty-four hours”;
3. Proposed deletion of text in the current regulation that is repetitive of statutory provisions;
4. Proposed deletion of the Federal wards provision in the current regulation;
5. Proposed deletion of provisions in the current regulation rendered obsolete by the 2002 JJDPA reauthorization;
6. Proposed deletion of requirements in the current regulation not specific to the formula grant program and are found elsewhere such as in the Uniform Administrative Requirements, Cost Principles and Audit Requirements for Federal Awards, at 2 CFR part 200;
7. Proposed deletion of provisions that describe recommendations rather than requirements;
8. Proposed deletion of provisions that are unnecessary or duplicative of the formula grant program solicitation;
9. Prohibited discrimination provision (§ 31.4 in the proposed rule) (
10. Proposed formula allocation (§ 31.5 in the proposed rule) (which would not alter the formula described in the Act at 42 U.S.C. 5632, but would simply require that a State's annual allocation be based on data available from the U.S. Census Bureau);
The proposed provision (§ 31.8(c) in the NPRM) requiring that a designated State official certify that the information in the State's compliance monitoring report is correct and complete is not being codified in this partial final rule, but this certification is already required under OJJDP's current policy on “Monitoring of State Compliance with the Juvenile Justice and Delinquency Prevention Act.”
Based heavily on feedback from commenters, and in conjunction with statisticians in OJP's Bureau of Justice Statistics, OJJDP has developed new compliance standards using the distribution of compliance rates reported in States' compliance monitoring reports. The compliance standards included in section 31.303(f)(6) of this rule are significantly different from the standards contained in section 31.303(f)(6) of the current formula grant program regulations, as well as from those in the proposed rule. OJJDP believes that the methodology for establishing new compliance standards included in this partial final rule fully addresses the concerns raised by commenters, which are discussed more fully below.
In determining the compliance standards, the distribution of each set of compliance rates (
As provided in the final rule, section 31.303(f)(6) provides that, based on this information, a compliance rate that is not less than one standard deviation above the mean rate will be set as the compliance standard. Once established, the standards will be posted annually (in numerical form) on OJJDP's Web site by August 31 of each year. Any State that reports a compliance rate above this compliance standard will be determined to be out of compliance. This methodology will not be applied, however, to States' FY 2016 and FY 2017 compliance monitoring reports, in order to allow for a transition period.
Under the revised methodology described above, only data from Calendar Year (CY) 2013 will be used to establish standards for making compliance determinations based on States' FY 2016 annual monitoring reports (affecting the FY 2017 awards). After removing one negative outlier from the DSO distribution (with a rate of 70.16 per 100,000 juvenile population), one negative outlier from the separation distribution (with a rate of 2.82 per 100,000 juvenile population), and one negative outlier in the jail removal distribution (with a rate of 82.8 per 100,000 juvenile population), the means without the negative outliers, the standard deviations, and what the compliance standards would be, based on two standard deviations above the means, is presented in the table below:
After removing the negative outlier from data for each of the three core requirements, the average rate, per 100,000 juvenile population, would be 2.85 for DSO, 0.04 for separation, and 2.38 for jail removal. Applying a standard deviation factor of 2 to each of these averages results in a final rate, per 100,000 juvenile population, of 9.89 for DSO, 0.28 for separation, and 8.94 for jail removal. States would need to be at, or below, these rates for OJJDP to find them in compliance with the DSO, separation, and jail removal core requirements.
As provided in this rule, amending section 31.303(f)(6) of the current regulation, OJJDP will employ the methodology described above in establishing annual compliance standards for DSO, separation, and jail removal core requirements for determinations based on States' FY 2016 data. Immediately following the publication of this partial final rule, OJJDP will post the standards for determining compliance with the DSO, separation and jail removal requirements, which will be derived from CY 2013 data and will be used in making compliance determinations based on States' FY 2016 compliance monitoring reports. These determinations will serve as the basis for establishing whether States will receive their full FY 2017 formula grant
As provided in this rule, amending section 31.303(f)(6), in establishing compliance standards to apply to the FY 2017 compliance data (affecting the FY 2018 awards), OJJDP will take the average of the combined CY 2013 and FY 2016 compliance data (removing, when appropriate/applicable, one negative outlier in each data collection period for DSO, separation, and jail removal) and apply a standard deviation factor of not less than one to establish the compliance standards to be applied to the FY 2017 compliance monitoring reports.
This methodology, which may result in compliance standards' being adjusted from one year to the next, recognizes the difficulty that States' face in preventing all instances of non-compliance with each core requirement and allows a State that reports a minimal number of such instances to be found in compliance and to continue to receive its full formula grant allocation.
OJJDP received numerous comments on the methodology for establishing the compliance standards in the proposed rule, and on the resulting standards published in the proposed rule. Commenters questioned the data used, the methodology employed to establish the standards, and the lack of opportunity to provide supporting documentation to address compliance deficiencies; they also raised the possibility of withdrawing from participation in the Formula Grant Program. Based on these comments, OJJDP has revised the compliance standards in the partial final rule, as discussed below, following a summary of the comments received.
A number of commenters raised concern with using data from only three States with the lowest rates of compliance, from each of the four Census Bureau regions. Several commenters also made the point that the data used in calculating the proposed compliance standards (CY 2013), did not include data based on the new guidance for “detain or confine,” rendering the calculation unfair, arbitrary, rigid, and extreme. In addition, several States suggested that in calculating a rate for the compliance standards, OJP should use the average of two or three years of data from all States, and those data should include data based on the “detain or confine” guidance.
A number of commenters stated that it would be unfair not to allow States to provide additional documentation demonstrating how they would address violations as they occur, in order to demonstrate compliance. For example, under the current compliance standards for DSO and jail removal, a State whose rate puts it out of compliance in principle could nevertheless demonstrate compliance with the
Additionally, many commenters stated that if their State incurred just one DSO, separation, or jail removal violation, the State would be out of compliance under the proposed standards, resulting in a reduction of their formula grant allocation by 20% for each requirement with which the State is out of compliance. In addition, the State would be required to expend 50% of its remaining allocation to achieve compliance.
In response, although the current regulation permits States with a certain number of instances of non-compliance nevertheless to be found in compliance with the
OJJDP appreciates the thoughtful and detailed comments regarding the methodology used to establish the proposed compliance standards for the DSO, separation, and jail removal core requirements. OJJDP agrees that using data from all States, not just three States with the lowest violation rates, from each of the four Census Bureau regions, would provide for a more representative and balanced approach for establishing compliance standards.
Several States questioned whether they would continue to participate in the Formula Grant Program, should the proposed compliance standards be implemented. It has never been OJJDP's intention to implement compliance standards that would discourage States' participation in the Formula Grant Program. OJJDP believes that the methodology described in this partial final rule to establish annual compliance standards is responsive to comments received and will encourage States' continued participation in the Formula Grant Program.
The partial final rule contains a definition for the term “detain or confine” in section 31.304(q) that differs in some respects from what was in the proposed rule. In response to the many comments received, OJJDP has revised the definition in two key respects: To clarify that (1) a juvenile who was not actually free to leave was “detained,” regardless of whether he believed he was free to leave; and (2) juveniles who are being held by law enforcement personnel for their own safety, and pending their reunification with a parent or guardian or pending transfer to the custody of a child welfare or social service agency, are not “detained or confined” within the meaning of the JJDPA.
OJJDP recognizes that the definition in the proposed rule may not have made sufficiently clear that the primary question in determining whether a juvenile was detained is whether he was, in fact, free to leave. If law
This revised definition also allows law enforcement to hold juveniles who (for example) are runaways, abandoned, endangered due to mental illness, homelessness, or drug addiction, or are victims of sex trafficking or other crimes, held pending their return to their parent or guardian or while law enforcement locates a safe environment in which to place them. In such instances, juveniles would not be considered to be “detained or confined” at all.
Before addressing the specific comments regarding the definition of “detain or confine” that was included in the proposed rule, OJJDP offers additional clarification of the impact of the definition of “detain or confine,” as used in the separation and jail removal requirements at 42 U.S.C. 5633(a)(12) and (13), respectively. First, those core requirements are applicable only in specific types of facilities. In determining whether there has been an instance of non-compliance with either of these core requirements, it is critical to note that the threshold inquiry must be “In what type of facility was the juvenile held?” An instance of non-compliance with the separation requirement can occur only in secure facilities in which juveniles have sight and sound contact with adult inmates.
OJP received many questions regarding whether specific scenarios would constitute a juvenile's being detained or confined, under the definition in the proposed rule. Because these were questions, rather than comments on the proposed rule, OJJDP will address them through guidance on OJJDP's Web site. OJJDP also encourages States to submit any additional questions about specific fact patterns, which will be posted along with answers on OJJDP's Web site.
Several commenters objected to OJJDP's adherence to Fourth Amendment jurisprudence in determining an appropriate definition of the phrase “detain or confine.”
In response, despite these commenters' opinions to the contrary, Fourth Amendment jurisprudence is applicable in the context of defining “detain or confine” for the purposes of the JJDPA, as the plain language of that phrase references the restraining of an individual's (in this context, a juvenile's) liberty, which, as the U.S. Supreme Court noted in
Moreover, while OJJDP recognizes that
One commenter questioned the reason for the proposed definition, stating that there has been either no research or at least no broadly published research that a significantly widespread problem exists that supports the implementation of the new definition.
In response, OJJDP notes that the purpose of including the definition of “detain or confine” in the proposed rule, and in the partial final rule, is to clarify that the separation and jail removal requirements are implicated when a juvenile is detained in certain settings, regardless of whether he is “securely” detained. As noted above, the word “detain” has a plain meaning in 4th Amendment jurisprudence. Under that jurisprudence, one can be detained without being “securely” detained such as by a show of authority.
Several commenters contended that the proposed definition of “detain or confine” is contrary to the intent of the drafters of the JJDPA, which was to protect juveniles held in secure custody. Because the term “detain or confine” is itself unambiguous, there is neither room for interpretation of the term nor warrant to attempt to determine—beyond what the plain text of the statute itself indicates—the “intent” of the drafters. Thus, OJJDP has not changed the definition to mean only secure detention.
One commenter suggested that OJJDP is proposing a new definition of “detain or confine,” in order to address problems in select jurisdictions, and that research should be conducted to determine the extent of the problem of “youth languishing in law enforcement custody in a non-secure environment.” In response, OJJDP believes that the commenter misunderstood the purpose for the inclusion of this definition, which is not to address concerns within specific jurisdictions, but to conform more closely to the JJDPA and to clarify for all jurisdictions the plain meaning of the term used in the statute.
Many commenters recommended that OJJDP maintain the current definition of “detain or confine,” which requires the physical restraint of a juvenile in a holding cell or locked interview room or by cuffing to a stationary object, because that would allow law enforcement to continue to detain a juvenile non-securely in a law enforcement facility for his own safety, and pending his return to his parent or guardian, without its resulting in an instance of non-compliance. Several commenters also stated that the proposed definition would give law enforcement the incentive to charge juveniles with a delinquent offense, or to charge them as adults because States could then detain them securely without a resulting instance of non-compliance.
In response, as explained above, OJJDP's revised definition in this rule clarifies that when law enforcement personnel are holding a juvenile only pending his return to his parent or guardian or pending his transfer to the custody of a child welfare or social service agency, he is not detained. OJJDP believes that the revised definition will allay the concerns raised by many commenters that under the proposed definition of “detain or confine,” law enforcement would have a disincentive to bring status offenders or non-offenders (such as runaways) to a law enforcement facility to hold them until a parent or guardian could pick them up.
One commenter requested that OJJDP clearly specify who qualifies as a parent or guardian, but that is a determination that should be made according to the law of the relevant State.
Several commenters questioned whether liability would attach if law enforcement personnel were to tell a juvenile that he was free to leave a law enforcement facility, the juvenile did leave the law enforcement facility, and as a result the juvenile suffered some harm. OJP believes it would not be appropriate for OJP to provide legal advice to States as to whether law enforcement personnel or a law enforcement agency could be held liable in such a situation.
Many commenters stated that the proposed definition of “detain or confine” is vague, ambiguous, or confusing in that it is difficult to know whether a juvenile in a particular situation would have understood that he was free to leave. Several commenters also stated that the proposed definition is too subjective and will make it extremely difficult for law enforcement to know when a juvenile is being “detained” for purposes of the Formula Grant Program.
OJJDP disagrees that the definition is vague, ambiguous or confusing. As noted above, the key question is whether the juvenile was, in fact, free to leave the law enforcement facility, because the juvenile's state of mind is irrelevant if he was not free to leave. Under the revised definition in this partial final rule, it is only in instances where law enforcement personnel assert that the juvenile actually was free to leave that the inquiry next proceeds to whether the juvenile understood that he was free to leave. Contrary to the commenters' assertions, however, this second inquiry does not necessitate that law enforcement “read the minds of juveniles” or determine whether a “reasonable juvenile” would have felt free to leave. Rather, in keeping with applicable Fourth Amendment jurisprudence, this second determination requires an objective examination of the circumstances surrounding the juvenile's interaction with law enforcement, including any circumstance that would have affected how a reasonable person in the juvenile's position would perceive his or her freedom to leave. Because a juvenile's age may affect how a reasonable person in his position would perceive his freedom to leave, consistent with U.S. Supreme Court precedent, where the juvenile's age is known to law enforcement, it must be a factor that is taken into consideration in making the determination.
One commenter stated that whether a juvenile believes he is free to leave is irrelevant to whether he is protected from potential harm by being in contact with an adult inmate. The same commenter stated that law enforcement personnel have the ability “simply by their presence . . . [to] limit conversation or other interaction between the juvenile and any adult inmate, thus limiting potential for harm.” In response, OJJDP believes that the commenter's quarrel is with the JJDPA itself. By its express terms, the statute's separation requirement is implicated when a juvenile is detained or confined in any institution in which he has contact with an adult inmate, regardless of whether law enforcement
At least one commenter noted that the proposed definition of “detain or confine” would cause a burden to law enforcement and complicate compliance monitoring activity, noting it will be cumbersome for law enforcement officers to collect relevant information every time a juvenile is brought to their departments. Additionally, several commenters questioned how law enforcement would document whether a juvenile knew that he was free to leave. In the preamble to the proposed rule, OJJDP gave as an example that law enforcement could produce a video recording of the juvenile indicating that he understood that he was free to leave. Commenters stated that requiring law enforcement personnel to make such a video recording is impractical and cost-prohibitive. OJJDP understands the additional burden that would create for a law enforcement agency. A more practical method of indicating that a juvenile understood that he was free to leave would be for law enforcement personnel to have the juvenile sign a form indicating that he understood he was free to leave, or for a law enforcement official to sign a form certifying that the juvenile was advised that he was free to leave.
One commenter expressed concern that juveniles who would not otherwise have their information put into a law enforcement database might now be entered into the system. We note that States could use paper forms that would be made available to the State's compliance monitor but need not be entered into any law enforcement computer system.
Several commenters questioned the use of the term “detain or confine” within the context of the DSO requirement. The commenter is correct that, unlike the separation and jail removal requirements, in which the term “detain or confine” is used, the DSO requirement is implicated when a juvenile is “placed” in a secure detention or secure correctional facility. The commenter asserted that the use of a different term—“placed”—for the DSO requirement—thus indicates that the term means something other than simply “detained or confined.”
In response, OJJDP notes that the “placement” of a juvenile in a secure detention or secure correctional facility means, at a minimum, that he is not free to leave and is, therefore detained (and confined). Therefore, a juvenile who has been “placed” has
In the proposed rule, for the purposes of determining whether the DSO requirement would be applicable, OJJDP had included a proposed definition of the term “placed or placement” to clarify that it would refer, not to
A commenter questioned whether, under the proposed rule, a juvenile under public authority could be required to participate in a “Scared Straight” or “shock incarceration” program in which he is brought into contact with an adult within an adult jail or lockup or in a secure correctional facility for adults, as a means of modifying his behavior. The commenter asked whether such participation would result in an instance of non-compliance with the jail removal and/or separation requirements when a parent has consented to the child's participation in the program, or in an instance in which the juvenile who is participating in the program as a form of diversion fails to complete the program and the original charge is reinstated. The commenter is apparently questioning whether the voluntariness of a juvenile's participation, and whether there would be consequences for not participating, in such a program would determine whether or not he was “detained” within sight or sight or sound contact of an adult inmate, resulting in an instance of non-compliance.
In response, OJJDP notes that whether such programs may result in instances of non-compliance with the separation and/or jail removal requirements will depend on the specific manner in which the program operates and the circumstances of the juveniles' participation in the program. A key factor in determining whether instances of non-compliance have occurred is whether juveniles participating in the program were free to leave the program while in sight or sound contact with adult inmates, regardless of whether the juvenile's initial participation was voluntary. If a parent or guardian has consented to his child's participation and may withdraw that consent at any time, the juvenile is not detained. States are encouraged to contact OJJDP for guidance about whether a particular program is resulting in—or has resulted in—instances of non-compliance. Generally speaking, if a juvenile participates in a program as a condition of diversion from the juvenile justice system, and does so with a parent's or guardian's consent, he is not detained, regardless of whether his failure to complete the program would result in the reinstatement of a charge against him.
Several commenters questioned how the proposed definition would apply to the provision allowing States to detain an accused delinquent offender for up to six hours for processing or release, while awaiting transfer to a juvenile facility, or in which period such juveniles make a court appearance, without a resulting instance of non-compliance. In response, OJJDP believes that no change in the final definition is needed in response to this comment. The definition in this rule would not alter the JJDPA exception at 42 U.S.C. 5633(a)(13)(A) that allows States to detain an accused delinquent offender for up to 6 hours for those purposes.
One commenter stated that there should be an exception to the application of the proposed definition of “detain or confine” for juveniles waived or transferred to a criminal court. In response, OJJDP believes that no change in the final definition is needed in response to this comment. The core requirements do not apply to juveniles who are under criminal court jurisdiction.
Another commenter recommended that if OJJDP decides to alter the current definition of “detain or confine”, it should create a “rural exception” to the rule that would allow non-metropolitan areas to continue to use the current
One commenter recommended that OJJDP remove the word “detain” from the definition and focus only on the confinement of juveniles, which the commenter asserts would be consistent with guidance provided in a memo from the OJJDP Administrator dated February 13, 2008. The Administrator's memorandum discusses the definition of an adult lockup, relevant to determining the facilities in which an instance of non-compliance with the jail removal requirement can occur. In response, OJJDP believes that no change in the definition is needed in response to this comment. The instances of non-compliance with the jail removal requirement addressed in the Administrator's memorandum can occur only in facilities that meet the definition of a “jail or lockup for adults” as defined in the JJDPA at 42 U.S.C. 5603(22). That definition requires that the facility must be a “locked facility.” Thus, instances of non-compliance with the jail removal requirement cannot occur in non-secure facilities. Nor, as discussed above, would a juvenile's detention in the non-secure portion of a law enforcement facility implicate the jail removal requirement.
Many commenters expressed concerns about whether the proposed rule would expand the types of facilities that must be included in the monitoring universe. In response, OJJDP has concluded that the definition of “detain or confine” in this final rule does not expand the current monitoring universe and that no change in the definition in the final rule is needed in response to this comment. Under OJJDP's current guidance, the following facilities must be monitored: Adult jails and lockups, secure detention facilities, secure correctional facilities, court holding facilities, and collocated facilities (which includes facilities previously listed). Non-secure facilities must be monitored periodically to ensure that they have not changed characteristics such that they have become secure facilities. OJJDP will respond to all comments regarding the scope of the monitoring universe in greater detail in the subsequent final rule that will be published in the future with respect to matters not covered in this partial final rule.
Many commenters questioned what additional data would be required under the proposed definition of “detain or confine,” and how those data should be collected. Under the proposed rule, as well as under the revised definition in this rule, law enforcement personnel in adult jails and lockups and other secure facilities in which both juveniles and adult inmates are detained, would be required to keep logs regarding juveniles who are detained securely
Several commenters expressed concern that OJJDP has not provided any training on the implementation of the “detain or confine” guidance, stating that it is unrealistic to expect States to apply this new guidance until appropriate training and technical assistance has been provided. Other commenters stated that it would be cost-prohibitive for States to provide such training to law enforcement personnel. Another commenter suggested that OJJDP should highlight successful models both for determining in what common situations a juvenile would likely believe he is not free to leave as well as examples of best practices for States with rural and/or diffuse populations.
In response, OJJDP intends to provide additional guidance materials regarding implementation of the proposed definition of “detain or confine” and is also planning to provide States with training in 2017 on how to monitor for, and collect and report data on compliance in accordance with that definition.
Many commenters expressed concern about the proposed requirement that 100% of facilities in their States be required to report annual compliance data.
In response, OJJDP believes that many of the commenters' concerns may have arisen from the belief that the proposed rule would have expanded the monitoring universe to include additional facilities with respect to which States are not currently collecting data. As discussed above, under the proposed rule and, more importantly, under this partial final rule, the monitoring universe does not change, and States will continue to be required to monitor adult jails and lockups, secure detention facilities, secure correctional facilities, and any other institutions (secure facilities) in which juveniles might have contact with adult inmates. (States must also continue to monitor non-secure facilities to ensure that they have not changed physical characteristics such that they have become secure facilities.)
A few commenters suggested that the number of facilities that must report be reduced. (Various commenters respectively suggested 85%, 90%, or 95% as being a more practical requirement than the 100% level in the proposed rule.) In response, OJJDP acknowledges and understands the challenges described by the States in their comments, and this partial final rule has revised the proposal, so that States will be required to collect and report compliance data for 85% of facilities and to demonstrate how they would extrapolate and report, in a statistically valid manner, data for the remaining 15% of facilities.
Under the JJDPA at 42 U.S.C. 5633(a)(14), the state plan that each
A few commenters indicated concern with the “good cause” standard in the proposed rule allowing for waiver of the proposed requirement for States to report data from 100% of facilities. In response, OJJDP notes that the reduction from 100% to 85% of the number of facilities required to report eliminates the need for a waiver exception to the reporting requirement, and that proposal is not included in this final rule.
Many commenters objected to the language in the proposed rule requiring that States provide compliance data on a fiscal-year basis, because of the shortened period States will have for submitting compliance data from the time the reporting period ends on September 30th of each year and the proposed deadline of January 31st for submitting their data. A few commenters noted that the period in which States will be collecting and verifying their data includes several holidays during which staff often take leave and also occurs during a period in which weather conditions make travel difficult within many States.
Additionally, commenters expressed concern that this shortened timeframe would present significant challenges to submission of accurate data (especially in light of the requirement to collect data from 100% of facilities) and would require additional resources to do so. A few commenters recommended extending the deadline, for instance, to March 15th or March 31st.
OJJDP has carefully considered these comments. The JJDPA itself requires reporting data on a fiscal-year basis, which was the reason for conforming the regulatory reporting period to the statutory requirement.
In response to the concerns raised and balancing them with OJJDP's need for sufficient time to complete compliance determinations that will inform that year's awards, OJJDP has extended the deadline in this partial final rule to February 28th, with the possibility of an extension to March 31st if a State were to demonstrate good cause.
One commenter questioned whether the proposed requirement that 100% of facilities report compliance data annually would affect the requirement in section 31.303(f)(5) of the current regulation that States may submit a minimum of six months' of data for a reporting period. The proposed rule indicated that States' compliance monitoring reports must contain data for “one full federal fiscal year.”
In response, OJJDP has clarified the applicability of this language. This partial final rule amends section 31.303(f)(5) to delete the language allowing States to report “not less than six months of data,” thus making it clear that States are required to provide compliance data for the full twelve-month reporting period. (And, as noted above, this partial final rule provides that States must submit data from 85% of facilities that are required to report compliance data.)
In accordance with the Regulatory Flexibility Act (5 U.S.C. 605(b)), the Office of Juvenile Justice and Delinquency Prevention has reviewed this regulation and, by approving it, certifies that it will not have a significant economic impact on a substantial number of small entities. The Formula Grant Program provides funding to States pursuant to a statutory provision, which is not affected by this regulation. Because States have complete discretion as to which local governments and other entities will receive formula grant funds through subgrants, as well as the amount of any subgrants, this rule will have no direct effect on any particular local governments or entities.
OJJDP received more than one comment disagreeing with OJJDP's assessment that the proposed regulation will not have a significant economic impact on a substantial number of small entities. OJJDP's basis for so certifying is that the rule regulates only States and territories, which are the recipients of funding under the Formula Grant Program. Commenters argued that the proposed rule, if made final as proposed, potentially would result in as many as 48 States being out of compliance with one or more of the core requirements. One commenter notes that because the States are required by statute to pass through 66
OJJDP disagrees with these comments because, as noted above, only grants to States and territories are regulated by the rule. Nonetheless, in this partial final rule, OJJDP has revised significantly the compliance standards, and expects that under the revised standards only eight States are likely to be out of compliance with one or more of the core requirements under the Act, and to receive a reduction in funding as a result.
This rule has been drafted and reviewed in accordance with Executive Order 12866, “Regulatory Planning and Review” section 1(b), Principles of Regulation, and in accordance with Executive Order 13563 “Improving Regulation and Regulatory Review” section 1(b), General Principles of Regulation.
The Office of Justice Programs has determined that this rule is a “significant regulatory action” under Executive Order 12866, section 3(f), Regulatory Planning and Review, and accordingly this rule has been reviewed by the Office of Management and Budget. This partial final rule makes important improvements in the setting of annual compliance standards for the States, clarifies the definition of “detain or confine,” and makes other
Executive Order 13563 directs agencies to propose or adopt a regulation only upon a reasoned determination that its benefits justify its costs; tailor the regulation to impose the least burden on society, consistent with obtaining the regulatory objectives; and, in choosing among alternative regulatory approaches, select those approaches that maximize net benefits. Executive Order 13563 recognizes that some benefits and costs are difficult to quantify and provides that, where appropriate and permitted by law, agencies may consider and discuss qualitative values that are difficult or impossible to quantify, including equity, human dignity, fairness, and distributive impacts.
This most significant provision of this rule updates the standards for determining compliance with the DSO, separation, and jail removal requirements, which have not been updated since 1981 for DSO, 1994 for separation, and 1988 for jail removal. The new compliance standards in this rule were carefully considered in light of the potential costs and benefits that would result and are narrowly tailored to recognize the significant progress that States have made over the last 35 years while ensuring that States continue to strive to protect juveniles within the juvenile justice system.
One commenter stated that in the Regulatory Certifications section of the preamble to the proposed rule (section V.), “the classical argument between state rights vers[u]s federal powers is mentioned in great detail and so we feel should be addressed.” OJJDP does not agree that that section includes any discussion of States' rights in relation to the federal government, or that any such discussion would be relevant. The Formula Grant Program does not impose any mandates on States; nor does it interfere with States' sovereignty, authorities, or rights. States, rather, participate in the program voluntarily and, as a condition of receipt of funding to improve their juvenile justice systems and to operate juvenile delinquency prevention programs, agree to comply with the program's requirements.
This rule will not have substantial direct effects on the States, on the relationship between the national government and the States, or on distribution of power and responsibilities among the various levels of government, as the rule only affects the eligibility for, and use of, federal funding under this program. The rule will not impose substantial direct compliance costs on State and local governments, or preempt any State laws. Therefore, in accordance with Executive Order No. 13132, it is determined that this rule does not have sufficient federalism implications to warrant the preparation of a Federalism Assessment.
This rule meets the applicable standards set forth in sections 3(a) & (b)(2) of Executive Order No. 12988. Pursuant to section 3(b)(1)(I) of the Executive Order, nothing in this or any previous rule (or in any administrative policy, directive, ruling, notice, guideline, guidance, or writing) directly relating to the Program that is the subject of this rule is intended to create any legal or procedural rights enforceable against the United States, except as the same may be contained within subpart B of part 94 of title 28 of the Code of Federal Regulations.
This rule will not result in the expenditure by State, local and tribal governments, in the aggregate, or by the private sector, of $100,000,000 or more in any one year, and it will not significantly or uniquely affect small governments. The Formula Grant Program provides funds to States to improve their juvenile justice systems and to support juvenile delinquency prevention programs. As a condition of funding, States agree to comply with the Formula Grant Program requirements. Therefore, no actions are necessary under the provisions of the Unfunded Mandates Reform Act of 1995.
This rule is not a major rule as defined by 5 U.S.C. 804. This rule will not result in an annual effect on the economy of $100,000,000 or more; a major increase in costs or prices; or significant adverse effects on competition, employment, investment, productivity, innovation, or on the ability of United States-based companies to compete with foreign- based companies in domestic and export markets.
This rule does not propose any new, or changes to existing, “collection[s] of information” as defined by the Paperwork Reduction Act of 1995 (44 U.S.C. 3501,
Administrative practice and procedure, Formula Grant Program, Juvenile delinquency prevention, Juvenile justice, Juvenile Justice and Delinquency Prevention Act (JJDPA).
Accordingly, for the reasons set forth in the preamble, part 31 of chapter I of Title 28 of the Code of Federal Regulations is amended as follows:
42 U.S.C 5611(b); 42 U.S.C. 5631-5633.
The revisions read as follows:
(f) * * *
(5)
(6)
(i) In determining the compliance standards to be applied to States' FY 2016 compliance monitoring data, the Administrator shall collect all of the data from each of the States' CY 2013 compliance reports, remove one negative outlier in each data collection period for DSO, separation, and jail removal, and apply a standard deviation factor of two to establish the compliance standards to be applied, which shall be posted on OJJDP's Web site no later than March 3, 2017.
(ii) In determining the compliance standards to be applied to States' FY 2017 compliance monitoring data, the Administrator shall collect all of the data from each of the States' CY 2013 and FY 2016 compliance reports (removing, when appropriate or applicable, one negative outlier in each data collection period for DSO, separation, and jail removal) and apply a standard deviation factor of not less than one to establish the compliance standards to be applied, which shall be posted on OJJDP's Web site by August 31, 2017.
(iii) In determining the compliance standards to be applied to States' FY 2018 and subsequent years' compliance monitoring data, the Administrator shall take the average of the States' compliance monitoring data from not less than two years prior to the compliance reporting period with respect to which the compliance determination will be made (removing, when applicable, one negative outlier in each data collection period for DSO, separation, and jail removal) and apply a standard deviation of not less than one to establish the compliance standards to be applied, except that the Administrator may make adjustments to the methodology described in this paragraph as he deems necessary and shall post the compliance standards on OJJDP's Web site by August 31st of each year.
(q)
Office of Foreign Assets Control, Treasury.
Final rule.
The Department of the Treasury's Office of Foreign Assets Control (OFAC) is amending the Sudanese Sanctions Regulations to authorize all prohibited transactions, including transactions involving property in which the Government of Sudan has an interest. OFAC is issuing this general license in connection with ongoing U.S.-Sudan bilateral engagement and in response to positive developments in the country over the past six months related to bilateral cooperation, the ending of internal hostilities, regional cooperation, and improvements to humanitarian access.
The Department of the Treasury's Office of Foreign Assets Control: Assistant Director for Licensing, tel.: 202-622-2480, Assistant Director for Regulatory Affairs, tel.: 202-622-4855, Assistant Director for Sanctions Compliance & Evaluation, tel.: 202-622-2490; or the Department of the Treasury's Office of the Chief Counsel (Foreign Assets Control), Office of the General Counsel, tel.: 202-622-2410.
This document and additional information concerning OFAC are available from OFAC's Web site (
OFAC is amending the Sudanese Sanctions Regulations (the “Regulations”) to add section 538.540, authorizing all transactions prohibited by the Regulations and by Executive Orders 13067 and 13412, effective as of January 17, 2017. Newly authorized transactions include the processing of transactions involving persons in Sudan; the importation of goods and services from Sudan; the exportation of goods, technology, and services to Sudan; and transactions involving property in which the Government of Sudan has an interest.
OFAC is issuing this rule in connection with ongoing U.S.-Sudan bilateral engagement and in order to support and sustain positive developments in the country over the past six months. In conjunction with this engagement, the U.S. government has supported the Sudanese government's ongoing efforts, including its cessation of military offensives in Darfur and the Two Areas, its cooperative efforts to resolve the ongoing conflict in South Sudan and cease any activity to undermine stability there, to improve access for humanitarian assistance by reducing government obstruction and streamlining governing regulations, and to enhance bilateral counterterrorism and security cooperation, including efforts to counter the Lord's Resistance Army.
Notwithstanding these positive developments in Sudan and the decision to amend the Regulations today to authorize all transactions prohibited by the Regulations, section 906 of the Trade Sanctions Reform and Export Enhancement Act of 2000, as amended (22 U.S.C. 7201
This new general license does not eliminate the need to comply with other provisions of 31 CFR chapter V including those parts related to terrorism, the proliferation of weapons of mass destruction, or narcotics trafficking, or other applicable provisions of law, including any requirements of agencies other than OFAC. Such requirements include, for example, the Export Administration Regulations (15 CFR parts 730 through 774) administered by the Bureau of Industry and Security of the Department of Commerce. This general license does not affect past, present, or future enforcement actions or investigations with respect to any violations, including apparent or alleged violations, of the Regulations that occurred prior to the effective date of this final rule.
Because the amendment of the Regulations involves a foreign affairs function, the provisions of Executive Order 12866 and the Administrative Procedure Act (5 U.S.C. 553) requiring notice of proposed rulemaking, opportunity for public participation, and delay in effective date are inapplicable. Because no notice of proposed rulemaking is required for this rule, the Regulatory Flexibility Act (5 U.S.C. 601-612) does not apply.
The collections of information related to the Regulations are contained in the RPPR. Pursuant to the Paperwork Reduction Act of 1995 (44 U.S.C. 3507), those collections of information have been approved by the Office of Management and Budget under control number 1505-0164. An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless the collection of information displays a valid control number.
Administrative practice and procedure, Banks, Banking, Foreign trade, Sanctions, Services, Sudan.
For the reasons set forth in the preamble, the Department of the Treasury's Office of Foreign Assets Control amends 31 CFR part 538 to read as follows:
3 U.S.C. 301; 18 U.S.C. 2339B, 2332d; 31 U.S.C. 321(b); 50 U.S.C. 1601-1651, 1701-1706; Pub. L. 101-410, 104 Stat. 890 (28 U.S.C. 2461 note); 22 U.S.C. 7201-7211; Pub. L. 109-344, 120 Stat. 1869; Pub. L. 110-96, 121 Stat. 1011 (50 U.S.C. 1705 note); E.O. 13067, 62 FR 59989, 3 CFR, 1997 Comp., p. 230; E.O. 13412, 71 FR 61369, 3 CFR, 2006 Comp., p. 244.
(a) All transactions prohibited by this part and Executive Orders 13067 and 13412, including all transactions that involve property in which the Government of Sudan has an interest, are authorized.
(b) Pursuant to section 906(a)(1) of the Trade Sanctions Reform and Export Enhancement Act of 2000 (22 U.S.C. 7205), any exports or reexports of agricultural commodities, medicine, or medical devices to the Government of Sudan, to any individual or entity in Sudan, or to any person in a third country purchasing specifically for resale to any of the foregoing must be shipped within the 12-month period beginning on the date of the signing of the contract for export or reexport.
Section 538.540 authorizes all transactions necessary to unblock any property or interests in property that were blocked pursuant to 31 CFR 538.201 prior to January 17, 2017, including the return or processing of funds.
This authorization is effective on January 17, 2017 and does not eliminate the need to comply with other provisions of 31 CFR chapter V or other applicable provisions of law, including any requirements of agencies other than the Department of the Treasury's Office of Foreign Assets Control. Such requirements include the Export Administration Regulations (15 CFR parts 730 through 774) administered by the Bureau of Industry and Security of the Department of Commerce and the International Traffic in Arms Regulations (22 CFR parts 120 through 130) administered by the Department of State.
Consistent with section 906(a)(1) of the Trade Sanctions Reform and Export Enhancement Act of 2000 (22 U.S.C. 7205), each year OFAC will determine whether to revoke this general license. Unless revoked, the general license will remain in effect.
Coast Guard, DHS.
Notice of enforcement of regulation.
The Coast Guard will enforce a security zone associated with the North American International Auto Show, Detroit River, Detroit, MI. This security zone is intended to restrict vessels from a portion of the Detroit River in order to ensure the safety and security of participants, visitors, and public officials at the North American International Auto Show (NAIAS), which is being held at Cobo Hall in downtown Detroit, MI. Vessels in close proximity to the security zone will be subject to increased monitoring and boarding during the enforcement of the security zone. No person or vessel may enter the security zone while it is being enforced without permission of the Captain of the Port Detroit.
The security zone regulation described in 33 CFR 165.915(a)(3) will be enforced from 8 a.m. on January 9, 2017 through 11:59 p.m. on January 22, 2017.
If you have questions on this document, call or email Tracy Girard, Prevention, U.S. Coast Guard Sector Detroit, 110 Mount Elliot Ave., Detroit, MI 48207; telephone (313) 568-9564; email
The Coast Guard will enforce the North American International Auto Show, Detroit River, Detroit, MI security zone listed in 33 CFR 165.915(a)(3). This security zone includes all waters of the Detroit River encompassed by a line beginning at a point of origin on land adjacent to the west end of Joe Lewis Arena at 42°19.44′ N., 083°03.11′ W.; then extending offshore approximately 150 yards to 42°19.39′ N., 083°03.07′ W.; then proceeding upriver approximately 2000 yards to a point at 42°19.72′ N., 083°01.88′ W.; then proceeding onshore to a point on land adjacent the Tercentennial State Park at 42°19.79′ N., 083°01.90′ W.; then proceeding downriver along the shoreline to connect back to the point of origin. All coordinates are North American Datum 1983.
All persons and vessels shall comply with the instructions of the Captain of the Port Detroit or his designated on-scene representative, who may be contacted via VHF Channel 16.
Under the provisions of 33 CFR 165.33, no person or vessel may enter or remain in this security zone without the permission of the Captain of the Port Detroit. Each person and vessel in this security zone shall obey any direction or order of the Captain of the Port Detroit. The Captain of the Port Detroit may take possession and control of any vessel in this security zone. The Captain of the Port Detroit may remove any person, vessel, article, or thing from this security zone. No person may board, or take or place any article or thing on board any vessel in this security zone without the permission of the Captain of Port Detroit. No person may take or place any article or thing upon any waterfront facility in this security zone without the permission of the Captain of the Port Detroit.
Vessels that wish to transit through this security zone shall request permission from the Captain of the Port Detroit or his designated representative. Requests must be made in advance and approved by the Captain of Port before transits will be authorized. Approvals may be granted on a case by case basis. The Captain of the Port may be contacted via U.S. Coast Guard Sector Detroit on channel 16, VHF-FM. The Coast Guard will give notice to the public via Local Notice to Mariners and VHF radio broadcasts that the regulation is in effect.
This document is issued under authority of 33 CFR 165.915 and 5 U.S.C. 552 (a). If the Captain of the Port determines that this security zone need not be enforced for the full duration stated in this document; he may suspend such enforcement and notify the public of the suspension via a Broadcast Notice to Mariners.
Department of Veterans Affairs.
Final rule; correcting amendment.
The Department of Veterans Affairs published in the
Crystal Cruz, Deputy Director, Healthcare Talent Management (10A2A4), Veterans Health Administration, Department of Veterans Affairs, 810 Vermont Ave. NW., Washington, DC 20420; (405) 552-4346. (This is not a toll-free number.)
VA published a final rule in the
Administrative practice and procedure, Alcohol abuse, Alcoholism, Claims, Day care, Dental health, Drug abuse, Government contracts, Grant programs—health, Grant programs—veterans, Health care, Health facilities, Health professions, Health records, Homeless, Medical and Dental schools, Medical devices, Medical research, Mental health programs, Nursing homes, Reporting and recordkeeping requirements, Travel and transportation expenses, Veterans.
In the final rule document published on September 29, 2016, at 81 FR 66815, make the following correction:
1. On page 66815, in the first column, in the
For the reasons set out in the preamble, VA is correcting 38 CFR part 17 by making the following correcting amendments:
38 U.S.C. 501, and as noted in specific sections. Sections 17.640 and 17.647 also issued under Pub. L. 114-2, sec. 4.
Sections 17.641 through 17.646 also issued under 38 U.S.C. 501(a) and Pub. L. 114-2, sec. 4.
Surface Transportation Board.
Final rule.
The Surface Transportation Board (Board) is issuing a final rule to implement the annual inflationary adjustment to its civil monetary penalties, pursuant to the Federal Civil Penalties Inflation Adjustment Act Improvements Act of 2015.
This final rule is effective January 17, 2017, and is applicable beginning January 13, 2017.
Sarah Fancher: (202) 245-0355. Federal Information Relay Service (FIRS) for the hearing impaired: 1-800-877-8339.
The Federal Civil Penalties Inflation Adjustment Act Improvements Act of 2015 (2015 Act), passed as part of the Bipartisan Budget Act of 2015, Public Law 114-74, 129 Stat. 599, requires agencies to adjust their civil penalties for inflation annually, beginning on January 15, 2017, and no later than January 15 of every year thereafter. In accordance with the 2015 Act, annual inflation adjustments will be based on the percent change between the Consumer Price Index for all Urban Consumers (CPI-U) for October of the previous year and the October CPI-U of the year before that. Penalty level adjustments should be rounded to the nearest dollar.
The statutory definition of civil monetary penalty covers various civil penalty provisions under the Rail (Part A), Motor Carriers, Water Carriers, Brokers, and Freight Forwarders (Part B), and Pipeline Carriers (Part C) provisions of the Interstate Commerce Act, as amended by the ICC Termination Act of 1995. The Board's civil (and criminal) penalty authority related to rail transportation appears at 49 U.S.C. 11901-11908. The Board's penalty authority related to motor carriers, water carriers, brokers, and freight forwarders appears at 49 U.S.C. 14901-14915. The Board's penalty authority related to pipeline carriers appears at 49 U.S.C. 16101-16106.
As set forth in this final rule, the Board is amending 49 CFR pt. 1022 so that its regulations and civil monetary penalties conform to the requirements of the 2015 Act. The adjusted penalties set forth in the rule will apply only to violations which occur after the effective date of this regulation.
In accordance with the 2015 Act, the annual adjustment adopted here is calculated by multiplying each current penalty by the cost-of-living adjustment factor of 1.01636, which reflects the percentage change between the October 2016 CPI-U (724.113) and the October 2015 CPI-U (712.458). The table at the end of this decision shows the relevant statutory provision of each civil penalty and a description, the current baseline statutory civil penalty level, and the adjusted statutory civil penalty level for 2017.
The final rule is set forth at the end of this decision. This final rule is issued without prior public notice or opportunity for public comment. The Administrative Procedure Act (APA), 5 U.S.C. 553(b)(B), does not require that process “when the agency for good cause finds” that public notice and comment are “unnecessary.” Here, Congress has mandated that the agency make the inflation adjustment to its civil monetary penalties. The Board has no discretion to set alternative levels of adjusted civil monetary penalties, because the amount of the inflation adjustment must be calculated in accordance with the statutory formula. The Board simply determines the amount of inflation adjustments by performing technical, ministerial computations. Because the Board has no discretion to do anything except promulgate the rule and perform ministerial computations to apply it, the Board has determined that there is good cause to promulgate this rule without soliciting public comment and to make this regulation effective immediately upon publication.
The Regulatory Flexibility Act (RFA), as amended by the Small Business Regulatory Enforcement Fairness Act of 1996, 5 U.S.C. 801
This final rule does not contain a new or amended information collection requirement subject to the Paperwork Reduction Act of 1995, 44 U.S.C. 3501
Administrative practice and procedures, Brokers, Civil penalties, Freight forwarders, Motor carriers, Pipeline carriers, Rail carriers, Water carriers.
1. The Board amends its rules as set forth in this decision. Notice of the final rule will be published in the
2. This decision is effective on its date of service.
By the Board, Chairman Elliott, Vice Chairman Miller, and Commissioner Begeman.
For the reasons set forth in the preamble, part 1022 of title 49, chapter X, of the Code of Federal Regulations is amended as follows:
5 U.S.C. 551-557; 28 U.S.C. 2461 note; 49 U.S.C. 11901, 14901, 14903, 14904, 14905, 14906, 14907, 14908, 14910, 14915, 16101, 16103.
(b) The cost-of-living adjustment required by the statute results in the following adjustments to the civil monetary penalties within the jurisdiction of the Board:
Animal and Plant Health Inspection Service, USDA.
Proposed rule; reopening of comment period.
We are reopening the comment period for a proposed rule to allow the importation of Hass avocados from Colombia into the continental United States. We are also notifying the public of the availability of a revised pest risk assessment and risk management document associated with the proposed rule. This action will allow interested persons additional time to prepare and submit comments.
The comment period for the proposed rule published on October 27, 2016 (81 FR 74722) is reopened. We will consider all comments that we receive on or before February 16, 2017.
You may submit comments by either of the following methods:
•
•
Supporting documents and any comments we receive on this docket may be viewed at
Mr. David B. Lamb, Senior Regulatory Policy Specialist, USDA/APHIS/PPQ, 4700 River Road, Unit 133, Riverdale, MD 20737-1236; (301) 851-2103;
On October 27, 2016, we published in the
The pest risk assessment (PRA) that we used in order to draft the risk management document (RMD) associated with the rule, as well as the rule itself, considered
We are making the more recent version of the PRA available for public review and comment, as well as a revised version of the RMD that reflects this change. Because there were no pink hibiscus mealybug-specific provisions in the proposed rule, however, we do not consider it necessary to modify the provisions of the proposed rule.
Comments on the proposed rule were required to be received on or before December 27, 2016. We are reopening the comment period on Docket No. APHIS-2016-0022 for an additional 30 days. We will also consider all comments received between December 28, 2016, and the date of this notice. This action will allow interested persons additional time to review the new PRA and RMD, and prepare and submit comments.
7 U.S.C. 450, 7701-7772, and 7781-7786; 21 U.S.C. 136 and 136a; 7 CFR 2.22, 2.80, and 371.3.
Federal Aviation Administration (FAA), DOT.
Notice of proposed rulemaking (NPRM).
This action proposes to amend Class E airspace at Atlantic City, NJ, as Atlantic City Municipal/Bader Field has closed, requiring airspace reconfiguration at Atlantic City International Airport. Controlled airspace is necessary for the safety and management of instrument flight rules (IFR) operations Atlantic City International Airport.
Comments must be received on or before March 3, 2017.
Send comments on this proposal to: U.S. Department of Transportation, Docket Operations, 1200 New Jersey Avenue SE., West Bldg. Ground Floor, Rm. W12-140, Washington, DC 20590; Telephone: 1-800-647-5527, or 202-366-9826. You must identify the Docket No. FAA-2016-9344; Airspace Docket No. 16-AEA-7, at the beginning of your comments. You may also submit and review received comments through the Internet at
FAA Order 7400.11A, Airspace Designations and Reporting Points, and subsequent amendments can be viewed
FAA Order 7400.11, Airspace Designations and Reporting Points, is published yearly and effective on September 15.
John Fornito, Operations Support Group, Eastern Service Center, Federal Aviation Administration, P.O. Box 20636, Atlanta, Georgia 30320; telephone (404) 305-6364.
The FAA's authority to issue rules regarding aviation safety is found in Title 49 of the United States Code. Subtitle I, Section 106 describes the authority of the FAA Administrator. Subtitle VII, Aviation Programs, describes in more detail the scope of the agency's authority. This rulemaking is promulgated under the authority described in Subtitle VII, Part A, Subpart I, Section 40103. Under that section, the FAA is charged with prescribing regulations to assign the use of airspace necessary to ensure the safety of aircraft and the efficient use of airspace. This regulation is within the scope of that authority as it would amend Class E airspace at Atlantic City International Airport, Atlantic City, NJ.
Interested persons are invited to comment on this rule by submitting such written data, views, or arguments, as they may desire. Comments that provide the factual basis supporting the views and suggestions presented are particularly helpful in developing reasoned regulatory decisions on the proposal. Comments are specifically invited on the overall regulatory, aeronautical, economic, environmental, and energy-related aspects of the proposal.
Communications should identify both docket numbers and be submitted in triplicate to the address listed above. You may also submit comments through the Internet at
Persons wishing the FAA to acknowledge receipt of their comments on this action must submit with those comments a self-addressed stamped postcard on which the following statement is made: “Comments to Docket No. FAA-2016-9344; Airspace Docket No. 16-AEA-7.” The postcard will be date/time stamped and returned to the commenter.
All communications received before the specified closing date for comments will be considered before taking action on the proposed rule. The proposal contained in this notice may be changed in light of the comments received. A report summarizing each substantive public contact with FAA personnel concerned with this rulemaking will be filed in the docket.
An electronic copy of this document may be downloaded from and comments submitted through
You may review the public docket containing the proposal, any comments received, and any final disposition in person in the Dockets Office (see the
This document proposes to amend FAA Order 7400.11A, Airspace Designations and Reporting Points, dated August 3, 2016, and effective September 15, 2016. FAA Order 7400.11A is publicly available as listed in the
The FAA is considering an amendment to Title 14, Code of Federal Regulations (14 CFR) Part 71 to amend Class E airspace designated as an extension to Class C surface area, and Class E airspace extending upward from 700 feet or more above the surface at Atlantic City International Airport, due to the closing of Atlantic City Municipal/Bader Field from the airspace description as the airport has closed, no longer requiring controlled airspace.
Class E airspace designations are published in Paragraph 6003 and 6005, respectively, of FAA Order 7400.11A, dated August 3, 2016, and effective September 15, 2016, which is incorporated by reference in 14 CFR 71.1. The Class E airspace designation listed in this document will be published subsequently in the Order.
The FAA has determined that this proposed regulation only involves an established body of technical regulations for which frequent and routine amendments are necessary to keep them operationally current. It, therefore: (1) Is not a “significant regulatory action” under Executive Order 12866; (2) is not a “significant rule” under DOT Regulatory Policies and Procedures (44 FR 11034; February 26, 1979); and (3) does not warrant preparation of a Regulatory Evaluation as the anticipated impact is so minimal. Since this is a routine matter that will only affect air traffic procedures and air navigation, it is certified that this proposed rule, when promulgated, will not have a significant economic impact on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.
This proposal would be subject to an environmental analysis in accordance with FAA Order 1050.1F, “Environmental Impacts: Policies and Procedures” prior to any FAA final regulatory action.
Airspace, Incorporation by reference, Navigation (air).
In consideration of the foregoing, the Federal Aviation Administration proposes to amend 14 CFR part 71 as follows:
49 U.S.C. 106(f), 106(g); 40103, 40113, 40120; E.O. 10854, 24 FR 9565, 3 CFR, 1959-1963 Comp., p. 389.
That airspace extending upward from the surface within 2.7 miles either side of the Atlantic City VORTAC 303° radial extending from the 5-mile radius to 7.4 miles northwest of Atlantic City International Airport.
That airspace extending upward from 700 feet above the surface within a 7.2-mile radius of Atlantic City International Airport.
U.S. Customs and Border Protection, Department of Homeland Security; Department of the Treasury.
Notice of proposed rulemaking.
This document proposes amendments to the U.S. Customs and Border Protection (CBP) regulations pertaining to the enforcement of intellectual property rights. Specifically, CBP is proposing amendments to implement a section of the Trade Facilitation and Trade Enforcement Act of 2015 which requires CBP to prescribe regulatory procedures for the donation of technologies, training, or other support services for the purpose of assisting CBP in intellectual property enforcement. The proposed regulations would enhance CBP's intellectual property rights enforcement capabilities.
Comments must be received on or before March 3, 2017.
You may submit comments, identified by
• Federal eRulemaking Portal at
•
Garrett D. Wright, Chief, Donations Acceptance Program, Office of Field Operations, U.S. Customs and Border Protection, telephone (202) 344-2344.
Interested persons are invited to participate in this rulemaking by submitting written data, views, or arguments on all aspects of the proposed rule. U.S. Customs and Border Protection (CBP) also invites comments that relate to the economic, environmental, or federalism effects that might result from this proposed rulemaking. Comments that will provide the most assistance to CBP will reference a specific portion of the proposed rulemaking, explain the reason for any recommended change, and include data, information, or authority that supports such recommended change.
The Trade Facilitation and Trade Enforcement Act of 2015 (TFTEA), Public Law 114-125, 130 Stat. 122 (19 U.S.C. 4301 note), enacted February 24, 2016, includes an assortment of trade facilitation and trade enforcement provisions, including several that focus on improving CBP's intellectual property rights (IPR) enforcement at the border. Section 308(d) of the TFTEA requires the Commissioner of CBP to prescribe regulations that will enable CBP to receive donations of technologies, training, and other support services for the purpose of assisting CBP in detecting and identifying imports that infringe intellectual property rights.
In House Report 114-114, the House Ways and Means Committee stated that CBP should take steps to ensure that personnel dedicated to enforcement of IPR are effectively trained to detect and identify infringing imports. The Committee noted that much of the expertise in this area lies within the private sector, and that companies are most knowledgeable about their products and can provide valuable training to CBP on detection. H.R. 114-114 at 76.
This document proposes to implement section 308(d) of the TFTEA by promulgating a new subpart H to part 133 of title 19 of the Code of Federal Regulations, entitled “[D]onations of Intellectual Property Rights Technology and Support Services,” which would provide for the receipt and acceptance by CBP of donations of hardware, software, equipment, and similar technologies, as well as training and support services, for the purpose of assisting CBP in enforcing IPR. It is also proposed to add and reserve subpart G to part 133.
New subpart H, as set forth in proposed new § 133.61, prescribes the methods by which donations of IPR technology and support services may be made. Specifically, proposed 19 CFR 133.61(a) sets forth the scope of this section and identifies the relevant authority. Proposed 19 CFR 133.61(b) prescribes the conditions applicable to a donation offer and provides that CBP will notify the donor, in writing, if additional information is requested or if CBP has determined that it will not accept the donation. In this regard, it is noted that CBP will take into consideration all aspects of the proposed donation offer, including whether such offer would pose a real or potential conflict between the interests of the donor and the interests of the government. Proposed 19 CFR 133.61(c) provides that if CBP elects to accept a donation offer, CBP will enter into a signed, written agreement with an authorized representative of the donating entity that commemorates all applicable terms and conditions, and that an agreement to accept training and other support services must provide that the services or training are offered without the expectation of payment and that the service provider expressly waives any future claims against the government.
As noted above, pursuant to section 308(d) of the TFTEA, CBP is required to prescribe regulatory procedures for donations of hardware, software, equipment, and similar technologies, as well as training and support services, for the purpose of assisting CBP in enforcing IPR.
Acceptance of such donations must also be consistent with either section 482 of the Homeland Security Act of 2002, as amended by section 2 of the Cross-Border Trade Enhancement Act of 2016 (Pub. L. 114-279), or section 507 of the Department of Homeland Security Appropriations Act of 2004 (Pub. L. 108-90).
Section 482 of the Homeland Security Act replaced section 559 of Title V of Division F of the Consolidated Appropriations Act, 2014 (Pub. L. 113-76) and permits CBP, in consultation with the General Services Administration (GSA), to “enter into an agreement with any entity to accept a donation of personal property, money, or nonpersonal services” to be used for certain CBP activities at most ports of entry where CBP performs inspection services. Generally speaking, donations may be used for certain activities of CBP's Office of Field Operations, including expenses related to “(A) furniture, equipment, or technology, including the installation or deployment of such items; and (B) the operation and maintenance of such furniture, fixtures, equipment or technology.” Section 482(a)(3). To implement section 482, CBP will build upon its experience in implementing section 559 of Title V of Division F of the Consolidated Appropriations Act, 2014, where CBP and the GSA issued the
Donations that may not be accepted under section 482 may be considered under section 507 of the DHS Appropriations Act of 2004. Section 507 of the DHS Appropriations Act of 2004 made the DHS Gifts and Donations account (formerly the Federal Emergency Management Agency “Bequests and Gifts” account) “available to the Department of Homeland Security . . . for the Secretary of Homeland Security to accept, hold, administer and utilize gifts and bequests, including property, to facilitate the work of the Department of Homeland Security.” Title V, Public Law 108-90, 117 Stat. 1153-1154. DHS policy on the acceptance of gifts pursuant to section 507 is contained in DHS Directive 112-02 and DHS Instruction 112-02-001. The Secretary of DHS delegated the authority to accept and utilize gifts to the heads of certain DHS components, including the Commissioner of CBP, in DHS Delegation 0006.
Executive Orders 13563 and 12866 direct agencies to assess the costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, distributive impacts, and equity). Executive Order 13563 emphasizes the importance of quantifying both costs and benefits, of reducing costs, of harmonizing rules, and of promoting flexibility. This proposed rule is not a “significant regulatory action,” under section 3(f) of Executive Order 12866. Accordingly, the Office of Management and Budget has not reviewed this regulation.
This rule proposes amendments to the CBP regulations that would prescribe procedures for the voluntary donation of technology, training, and other support services for the purpose of assisting CBP in enforcing IPR, as required by section 308(d) of the Trade Facilitation and Trade Enforcement Act of 2015, Public Law 114-125, 130 Stat. 122 (19 U.S.C. 4301 note). These donations would improve CBP's knowledge of intellectual property and improve its ability to detect infringing articles and prevent their importation.
Because donations under this rule would be voluntary, CBP assumes that entities would only make donations if they believe it is in their best interest to do so. The cost of the donation itself, including any training provided, would vary greatly depending on the particulars of the donation. Due to a lack of data on the types of donations that entities would offer as a result of this rulemaking, CBP is unable to estimate the cost of these donations to the public. In addition to the cost of the donated product or training itself, donors would bear some paperwork related costs with this rule. Under this rule, if finalized, entities must submit an offer of a donation in writing to CBP and provide all pertinent details regarding the scope, purpose, expected benefits, intended use, estimated costs, and proposed conditions of the donation. Based on discussions with CBP's Office of Field Operations, CBP estimates that approximately 50 entities would make donations annually and that there would be one donation made per entity annually, for a total of 50 donations per year. CBP estimates that it would take an entity approximately 2 hours to write the offer of donation. In most cases, CBP believes that attorneys either employed or hired by the donor would write the offer of donation. Considering the median hourly wage of an attorney of $80.83,
In addition to donor costs, this rule would introduce a time cost to CBP to process each offer of donation. As with donor costs, CBP's cost to receive and learn about the donated article would depend on the particulars of the donation. Also, accepting the donation is voluntary on CBP's part and the agency would only accept the donation if it is in CBP's best interest to do so. In addition to CBP's costs associated with receiving and learning about the donated article, there are quantifiable costs to CBP related to evaluating the donation and making a decision on whether to accept it under the conditions provided. CBP estimates, at a minimum, the agency's evaluation time to be approximately 10 hours for each of the 50 donations made to CBP annually. CBP predicts that in most cases, each written offer of donation would be evaluated by five CBP employees. Based on the average hourly wage for a general CBP employee of $55.91,
In summary, this rule could result in a total quantifiable annual cost to the public of $8,083 and a total annual cost to CBP of $139,775.00. Additionally, the public would bear a cost equal to the value of the donation and CBP would bear a cost to accept the donation. As these costs would vary depending on the particulars of the donation, CBP is unable to quantify them in this analysis. Because donations are voluntary for both the donor and CBP, donations would presumably only occur if the benefits to each party outweigh the costs.
Along with costs, the proposed rule would provide benefits to the donor and CBP. In particular, the proposed rule would enhance CBP's IPR enforcement capabilities by making donations of authentication devices, equipment, and training available to CBP personnel. This would help protect the entities making donations from the illegal importation of IPR-infringing products. The value of this benefit would vary depending on how much an entity believes IPR enforcement would improve because of its donation. As stated earlier, an entity would only make the donation if it believes the benefits of improved IPR enforcement outweigh the costs.
The Regulatory Flexibility Act (5 U.S.C. 601
This proposed rule, if finalized, would allow entities to voluntarily donate technology, training, and other support services to improve CBP's ability to enforce IPR potentially related to their goods. As any entity with intellectual property could make these donations, this rule may affect a substantial number of small entities. However, this rule imposes no new obligations on entities, including those considered small. Any small entity that chooses to make these donations would presumably do so because it believes the benefits of donating exceed the costs. Therefore, this rule would not have a significant economic impact on small entities. Given these reasons, CBP certifies that this rule, if finalized, will not have a significant economic impact on a substantial number of small entities. CBP invites public comments on this determination.
An agency may not conduct, and a person is not required to respond to, a collection of information unless the collection of information displays a valid control number assigned by OMB.
OMB approved collection 1651-0123 will be amended to reflect a new information collection proposed by this rule for written offers of donations to CBP of technology, training, and other support services in accordance with 19 CFR 133.61(b). CBP estimates that this rule would result in 50 responses each year and 100 burden hours to respondents annually. The new information collection would reflect the burden hours for each written offer of donation provided to CBP as follows:
This proposed regulation is being issued in accordance with 19 CFR 0.1(a)(1) pertaining to the Secretary of the Treasury's authority (or that of his delegate) to approve regulations related to certain customs revenue functions.
Circumvention devices, Copying or simulating trademarks, Copyrights, Counterfeit goods, Customs duties and inspection, Detentions, Donations, Reporting and recordkeeping requirements, Restricted merchandise, Seizures and forfeitures, Technology, Trademarks, Trade names, Support services.
For the reasons set forth in the preamble, CBP proposes to amend 19 CFR part 133 as set forth below:
15 U.S.C. 1124, 1125, 1127; 17 U.S.C. 101, 601, 602, 603; 19 U.S.C. 66, 1202, 1499, 1526, 1624; 31 U.S.C. 9701.
Section 133.61 also issued under Sec. 308(d), Pub. L. 114-125; Sec. 507, Pub. L. 108-90; Sec. 2, Pub. L. 114-279.
(a)
(b)
(c)
Food and Drug Administration, HHS.
Notification of availability.
The Food and Drug Administration (FDA, we, or Agency) is announcing the availability of a revised draft guidance for industry entitled “Control of
Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that we consider your comment on the draft guidance before we issue the final version of the guidance, submit either electronic or written comments on the draft guidance by July 26, 2017.
You may submit comments as follows:
Submit electronic comments in the following way:
•
• If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see “Written/Paper Submissions” and “Instructions”).
Submit written/paper submissions as follows:
•
• For written/paper comments submitted to the Division of Dockets Management, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in “Instructions.”
• Confidential Submissions—To submit a comment with confidential information that you do not wish to be
Submit written requests for single copies of the revised draft guidance to the Office of Food Safety, Center for Food Safety and Applied Nutrition, Food and Drug Administration (HFS-300), 5001 Campus Dr., College Park, MD 20740. Send two self-addressed adhesive labels to assist that office in processing your request. See the
Jenny Scott, Center for Food Safety and Applied Nutrition (HFS-300), Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, 240-402-2166.
We are announcing the availability of a revised draft guidance for industry entitled “Control of
In the
Since issuing the 2008 draft
We have revised the 2008 draft
Part 117 defines “environmental pathogen” to mean a pathogen capable of surviving and persisting within the manufacturing, processing, packing, or holding environment such that food may be contaminated and may result in foodborne illness if that food is consumed without treatment to significantly minimize the environmental pathogen (21 CFR 117.3). Within that definition,
The revised draft guidance refers to previously approved collections of information found in FDA regulations. These collections of information are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (the PRA) (44 U.S.C. 3501-3520). The collections of information in part 117 have been approved under OMB Control No. 0910-0751.
FDA tentatively concludes that the revised draft guidance also contains proposed information collection provisions that are subject to review by OMB under the PRA but are not included in the information collection approved under OMB Control No. 0910-0751. “Collection of information” is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes Agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) requires Federal Agencies to provide a 60-day notice in the
Persons with access to the Internet may obtain the revised draft guidance at either
The following references are on display at the Division of Dockets Management (see
Environmental Protection Agency (EPA).
Proposed rule.
The Environmental Protection Agency (EPA) proposes to make conforming changes to existing drinking water regulations based on the Reduction of Lead in Drinking Water Act of 2011 (RLDWA) and the Community Fire Safety Act of 2013 (CFSA). Section 1417 of the Safe Drinking Water Act (SDWA) prohibits the use and introduction into commerce of certain plumbing products that are not lead free. The RLDWA revised the definition of lead free to lower the allowable maximum lead content from 8.0 percent to a weighted average of 0.25 percent of the wetted surfaces of plumbing products and established a statutory method for calculating lead content. In addition, the RLDWA created exemptions from the lead free requirements for plumbing products that are used exclusively for nonpotable services as well as for other specified products. The CFSA further amended section 1417 to exempt fire hydrants from these requirements.
EPA proposes to establish new requirements to assure that individuals purchasing, installing or inspecting potable water systems can identify lead free plumbing materials. Specifically, EPA proposes to establish labeling requirements to differentiate plumbing products that meet the lead free requirements from those that are exempt from the lead free requirements and to require manufacturers to certify compliance with the lead free requirements. These proposed requirements would reduce inadvertent use of non-lead free plumbing products in potable use applications and, consequently, reduce exposure to lead in drinking water and associated adverse health effects.
Comments must be received on or before April 17, 2017.
Submit your comments, identified by Docket ID No. EPA-HQ-OW-2015-0680, to the
For additional submission methods, the full EPA public comment policy, information about CBI or multimedia submissions, and general guidance on making effective comments, please visit
Russ Perkinson, telephone number: 202-564-4901; email address:
The statutory prohibitions on use and introduction into commerce of certain products that are not lead free codified by this rule apply to “any person” as defined in the Safe Drinking Water Act (SDWA). This rule implementing those provisions applies to any person who would introduce plumbing products into commerce, such as manufacturers, importers, wholesalers, distributors, re-sellers, retailers, and to any person who would use plumbing products in a public water system or in a residential or non-residential facility providing water for human consumption. If you have questions regarding the applicability of this action to a particular entity, consult the person listed in the
EPA is proposing this regulation to codify revisions to the SDWA prohibition on use and introduction into commerce of certain products that are not lead free (hereafter termed the SDWA lead prohibitions) as enacted in the Reduction of Lead in Drinking Water Act of 2011 (RLDWA) and the Community Fire Safety Act of 2013 (CFSA). EPA is also proposing requirements to certify and label plumbing products introduced into commerce to assure they are lead free.
SDWA 1417(a)(1) prohibits the “use of any pipe, any pipe or plumbing fitting or fixture, any solder, or any flux in the installation or repair of any public water system; or any plumbing in a residential or non-residential facility providing water for human consumption, that is not lead free” as defined in section 1417(d). Section 1417(a)(3) provides that “it shall be unlawful (A) for any person to introduce into commerce any pipe, or any pipe or plumbing fitting or fixture, that is not lead free, except for a pipe that is used in manufacturing or industrial processing; (B) for any person engaged in the business of selling plumbing supplies, except manufacturers, to sell solder or flux that is not lead free; or (C) for any person to introduce into commerce any solder or flux that is not lead free unless the solder or flux bears a prominent label stating that it is illegal to use the solder or flux in the installation or repair of any plumbing providing water for human consumption.”
The 2011 RLDWA revised section 1417 to redefine lead free in SDWA section 1417(d) to lower the maximum lead content from 8.0 percent to a weighted average of 0.25 percent of the wetted surfaces of plumbing products; established a statutory method for the calculation of lead content; and eliminated the requirement that lead free products be in compliance with voluntary standards established in accordance with SDWA 1417(e) for leaching of lead from new plumbing fittings and fixtures. In addition, the RLDWA created exemptions in SDWA section 1417(a)(4) from the prohibitions on the use or introduction into commerce for “pipes, pipe fittings, plumbing fittings, or fixtures, including backflow preventers, that are used exclusively for nonpotable services such as manufacturing, industrial processing, irrigation, outdoor watering, or any other uses where the water is not anticipated to be used for human consumption” (SDWA 1417(a)(4)(A)), as well as for “toilets, bidets, urinals, fill valves, flushometer valves, tub fillers, shower valves, service saddles, or water distribution main gate valves that are 2 inches in diameter or larger.” (SDWA 1417(a)(4)(B)). The CFSA further amended section 1417 to exempt fire hydrants.
In addition to codifying the revised requirements under RLDWA and CFSA, EPA is proposing product certification requirements and data gathering authorities to ensure consistent implementation and enforcement of the SDWA lead prohibition, as well as new labeling requirements to assure that individuals purchasing, installing or inspecting potable water systems can identify lead free plumbing materials. Specifically, EPA proposes to establish labeling requirements to differentiate plumbing products that meet the lead free requirements from those that are exempt from the lead free requirements and to require manufacturers to certify compliance with the lead free requirements. These proposed requirements would reduce inadvertent use of non-lead free plumbing products in potable use applications and, consequently, reduce exposure to lead in drinking water and associated adverse health effects.
The goals of these proposed regulatory provisions are to limit accidental lead exposure by clearly identifying those products to be used or not used for potable services; and to ensure that plumbing products that are identified as lead free for use in potable services meet the requirements of the SDWA lead prohibition.
EPA's authority for this proposed rule is sections 1417, 1445 and 1450 of the SDWA, 42 U.S.C. 300j-6, 300j-4, and 300j-9. SDWA section 1417 authorizes the EPA Administrator to “prescribe such regulations as are necessary or appropriate to carry out his/her functions under this subchapter.” EPA's current regulations (40 CFR 141.43) codify parts of section 1417 of the SDWA, but they do not reflect the current version of section 1417, as
EPA conducted an incremental compliance cost analysis of this proposed rule. For detail on the cost analysis see sections V and VI of this notice. The Technical Support Document (USEPA, 2016) prepared for this proposed rule and available in the docket for this proposed rule contains the detailed description of the cost assessment. EPA did not conduct a quantified and monetized benefits analysis, but a qualitative discussion of the benefits attributable to this rule can be found in section VII and in the Technical Support Document.
Total annualized costs for the proposed rule range from $12 million discounted at three percent to $18 million discounted at seven percent. These costs include administrative requirement costs, the cost to potable use product manufacturers for both labeling on the product and on the product's packaging, the cost to manufacturers employing the “used exclusively” exemption for package labeling indicating non-potable uses, third party and self-certification costs and the costs of responding to EPA data requests.
The proposed rule would reduce inadvertent use of non-lead free plumbing products in potable use applications and, as a result, would reduce exposure to lead in drinking water. The benefits of this proposed rule would be the resulting incremental reduction in the adverse health effects of low doses of lead, which include adverse neurological, cardiovascular, renal, reproductive, developmental, immunological and carcinogenic effects.
Lead can be introduced into drinking water by corrosion of plumbing products (pipes, pipe and plumbing fittings and fixtures, solder, and flux). Lead exposure causes damage to the brain and kidneys, and can interfere with the production of red blood cells that carry oxygen to all parts of the body. The greatest risk associated with lead exposure is to infants, young children and pregnant women. Scientists have linked the effects of lead on the brain with lowered IQ in children.
In 1986, Congress amended the SDWA to prohibit the use of pipes, solder or flux that are not “lead free” in public water systems or plumbing in facilities providing water for human consumption. At the time, lead free was defined as solder and flux with no more than 0.2 percent lead and pipes with no more than 8.0 percent lead.
In 1996, Congress further amended the SDWA to prohibit the use of pipe and plumbing fittings and fixtures that are not lead free in the installation and repair of any public water system or plumbing in a facility providing water for human consumption. The 1996 amendments also required lead free plumbing fittings and fixtures (endpoint devices) to be in compliance with a lead leaching standard established in accordance with section 1417(e).
The 1996 amendments also made it unlawful for any person to introduce into commerce any pipe, pipe or plumbing fitting, or fixture that is not lead free, except for a pipe that is used in manufacturing or industrial processing. As amended in 1996, SDWA section 1417(a)(3)(B) prohibits “any person engaged in the business of selling plumbing supplies, except manufacturers, to sell solder or flux that is not lead free,” and SDWA section 1417(a)(3)(C) makes it unlawful “for any person to introduce into commerce any solder or flux that is not lead free unless the solder or flux bears a prominent label stating that it is illegal to use the solder or flux in the installation or repair of any plumbing of water for human consumption.”
In 2011, Congress enacted the RLDWA. It revised the definition of lead free by lowering the allowable maximum lead content from 8.0 percent to a weighted average of 0.25 percent of the wetted surfaces of plumbing products. It also revised the definition of lead free to include a statutory method for the calculation of lead content, and eliminated the requirement that lead free products be in compliance with standards established in accordance with SDWA section 1417(e) for leaching of lead from new plumbing fittings and fixtures.
The 2011 RLDWA also established two types of exemptions from the section 1417 prohibitions on the use or introduction into commerce of pipes, pipe fittings, plumbing fittings or fixtures, solder or flux not meeting the statutory definition of lead free. One exemption is for pipes, pipe fittings, plumbing fittings or fixtures, including backflow preventers, that are used exclusively for non-potable services, such as manufacturing, industrial processing, irrigation, outdoor watering, or any other uses where the water is not anticipated to be used for human consumption (SDWA 1417(a)(4)(A)). A second exemption was established for toilets, bidets, urinals, fill valves, flushometer valves, tub fillers, shower valves, service saddles, or water distribution main gate valves that are 2 inches in diameter or larger (SDWA 1417(a)(4)(B)). The RLDWA established a prospective effective date of January 4, 2014, which provided a three-year timeframe for affected parties to transition to the new requirements. The CFSA further amended SDWA section 1417 to exempt fire hydrants from the prohibitions otherwise applicable under that section.
In anticipation of these changes taking effect, EPA provided a summary of the requirements of the lead ban provisions in SDWA section 1417 and answers to frequently asked questions (FAQs) related to the amendments to assist manufacturers, retailers, plumbers and consumers in understanding the changes to the law (USEPA, 2013a). In this FAQ document, EPA stated its intention to further evaluate and refine the issues raised in the FAQ in a future rulemaking.
A number of data sources were used in the characterization of the plumbing manufacturing industry. GMP Research, Inc., provided a report to EPA in 2014, which included data on the total number of both potable and non-potable plumbing products sold in 2013, distributed across 40 product subcategories, and the market share of the leading suppliers by each product subcategory that may be subject to EPA's proposed rule. These data were supplemented with information from a number of additional sources. Dun & Bradstreet data were obtained for those firms that were identified by North American Industry Classification System (NAICS) and Standard Industrial Classification (SIC) code classifications as potentially producing plumbing products that would be affected by the proposed rule. Additional data for plumbing manufacturers and fabricators were obtained from ThomasNet, a comprehensive online database that provides information on manufacturing firms in the United States. EPA also used NSF International's Certified Drinking Water System Components database, which provides a list of manufacturers who use NSF to certify
Information used in the development of industry production growth was obtained from both the GMP Research, Inc., report and projections on United States housing growth from IHS Global Insight. The Technical Support Document (USEPA, 2016) contains more information and data sources used and is available in the docket.
EPA conducted calls with representatives of both the PMI and the American Foundries Society (AFS) industry associations and held a stakeholder webinar in 2015 in order to obtain information on current practice within the plumbing parts manufacturing industry, in regard to labeling of product packages, marking of the plumbing products themselves, and the technical feasibility and costs associated with making changes to product labeling and marking. Additionally, the two industry associations provided information to EPA on product identification methods, including the estimated percentage of products that currently include lead free identification and general cost information for modifications to package labeling and product marking. Information on the feasibility and time requirements for changing production molds in response to potential regulatory requirements was also discussed, along with plumbing product inventory turnover rates. The trade associations also provided information on the use and costs of third party certification in the industry.
In addition, data were obtained from a number of independent geographically diverse tool and dye firms on the cost of mold modifications. EPA also contacted suppliers to obtain capital equipment and operations and maintenance (O&M) costs to allow the Agency to estimate the economic impact of potential new labeling requirements under the proposed rule. EPA also contacted the eight firms currently accredited to certify plumbing components for compliance with NSF/ANSI Standard 372, for information on the cost of certification and the technical process for testing and certifying products as meeting the standard.
The statutory prohibition on the use or introduction into commerce of pipes, pipe and plumbing fittings, fixtures, solder and flux that are not lead free, and the corresponding requirements described in this proposal would apply to any person. “Person” is defined under the SDWA to include individuals; corporations; companies; associations; partnerships; municipalities; or state, federal or tribal agencies. The statutory ban on selling solder and flux that is not lead free applies only to “any person engaged in the business of selling plumbing supplies.” The use prohibition applies only to use in the “installation or repair” of any public water system or any plumbing in a residential or nonresidential facility or location that provides water for human consumption.
EPA solicits comments on all aspects of the proposed approach set forth in this notice. EPA specifically solicits comments, information and data on the following topics:
1. In order to clarify the requirements, set forth in the RLDWA and this proposal, EPA defined terms, such as “pipes,” “fittings,” “fixtures,” “solder,” “flux” and several subcategories of these components, which are terms used in the statute, but are not defined within section 1417 of the SDWA. EPA included these and other definitions to provide clarity to provisions of the proposed rule. EPA requests comment concerning the appropriateness of these definitions and any additional terms that should be defined, specifically terms describing exempt products included in section 1417(a)(4)(B) of the SDWA (
2. Section 1461 of the SDWA defines lead free with respect to drinking water coolers to mean that “each part or component of the cooler which may come into contact with drinking water contains no more than 8 percent lead” except that any solder, flux or storage tank interior surface may not contain more than 0.2 percent lead. SDWA section 1461(2) also authorizes the Administrator to establish more stringent requirements for treating any part or component of a drinking water cooler as lead free “whenever he determines that any such part may constitute an important source of lead in drinking water.” A drinking water cooler is also a “fixture” under section 1417 of the SDWA; and, therefore, subject to the definition of lead free in section 1417. To give effect to both provisions, in practice, drinking water coolers would need to comply with the most restrictive of the requirements in sections 1417 and 1461 of the SDWA. For clarity, EPA could consider addressing the requirements of section 1461 in the final rule by inserting language such as: “In addition to the definitions of “lead-free” in § 143.12(a)(1) and (2), no drinking water cooler which contains any solder, flux, or storage tank interior surface which may come into contact with drinking water is lead free if the solder, flux, or storage tank interior surface contains more than 0.2 percent lead. Drinking water coolers must be manufactured such that each individual part or component that may come in contact with drinking water shall not contain more than 8 percent lead while still meeting the maximum 0.25 percent weighted average lead content of the wetted surfaces of the entire product.” Should EPA consider adding such a provision to the rule?
3. The regulatory modifications in this proposal are designed, in part, to make the requirements set forth in section 1417 of the SDWA clearer and easier to implement and enforce in a consistent manner. Are additional clarifications needed to improve the regulation? If so, what specific clarifications are needed?
EPA evaluated several options concerning labeling of products that comply with the definition of lead free, including a requirement to label a product's packaging, physically marking a product, or a combination of both. EPA found that many manufacturers already utilize a combination of package and product labeling to inform product users that the products comply with the RLDWA and several similar state laws. In an effort to reduce consumer confusion and establish a consistent labeling scheme for these products, EPA proposes to require that all lead free products be labeled on the package, container or tag, as well as marked directly on the product, unless the product is too small for a legible marking (in a type approximately 8 point to 14 point depending on the method of marking and roughness of product surface). Direct product marking to indicate lead free status will assist building inspectors in verifying that installations are in compliance with plumbing codes and allow for identification of products if they become separated from packaging prior to installation. Separation from
This proposal provides that products that are too small to be marked on the product would be exempt from product marking, but would still need to comply with package, container or tag labeling. Also, when marking a product directly, the manufacturer should, to the extent practical, locate the marking in an area where it would be visible after installation. For those products where visual aesthetics is a factor in marketing and selling the product, the manufacturer may locate the marking in a manner that will not negatively impact the design.
EPA is not proposing a specific phrase be required on products or packages, but rather a performance standard that the phrase clearly conveys to users that the product is in compliance with the lead free requirements of the SDWA. The proposed regulation would include these examples of acceptable phrases for packaging: “This product conforms to the lead free requirements of the SDWA,” or “Lead Free.” Examples of acceptable product markings include: “Lead Free,” “LF,” or appropriate third party certification markings such as NSF/ANSI 372.
The requirements EPA proposes for lead free products will ensure that purchasers of plumbing products do not inadvertently use products that are not lead free, or re-introduce them into commerce for potable applications (
EPA solicits comments on all aspects of the proposed approach set forth above. In addition, EPA specifically solicits comments, information and data on the following topics:
1. Whether the rule should require the specific phrase “lead free” on package labeling and product markings rather than allowing some discretion in the use of phrases.
2. Whether an alternative specific phrase should be required for product and package labeling and, if so, what phrase.
3. If a specific phrase such as “lead free” were required, what period of time should be allowed for a transition period to enable manufacturers to modify their product and packaging to incorporate such phrase?
4. If products were required to use a specific phrase such as “lead free,” whether that specific phrase should be required on both the package label and product marking or whether an abbreviated message should instead be allowed on the product.
5. Whether the rule should allow for either package labeling or product marking rather than package labeling and product marking.
6. Whether the rule should require any package labeling or product marking.
As a result of the exemptions created by the RLDWA, there will be plumbing products in the marketplace that are not required to meet the definition of lead free in section 1417(d) of the SDWA. Therefore, without appropriate labeling, there is a risk that non-lead free products will be inadvertently used in potable water applications or re-introduced into commerce for potable applications. There are several points along the distribution chain where EPA anticipates a non-lead free product could be mistakenly identified as a lead free product, including the initial sale of the product and at the time of installation.
Prior to the RLDWA, all plumbing devices were required to contain less than 8.0 percent lead, and certain endpoint devices (
One of the exemptions allows the use and introduction into commerce of pipes, fittings and fixtures that are used exclusively for nonpotable services. EPA has determined that a plumbing product that is physically incompatible with potable drinking water systems, rendering it impossible to be used for potable service, qualifies for this exemption.
In addition, EPA also proposes a second option for manufacturers to demonstrate that their product is “used exclusively” for nonpotable services and therefore eligible for this exemption (hereafter referred to in this notice as the “used exclusively” exemption). As EPA explained in the RLDWA FAQs, EPA would generally consider pipes, fittings or fixtures to be used exclusively for nonpotable services if they are marketed and sold for use in nonpotable services, and prominently and clearly labeled as illegal for use in potable services and not anticipated for use with water for human consumption. This proposal would codify that interpretation of this exemption by allowing the use of a package label (or the product marking for those products sold without an external package) clearly identifying the product as not for use with water for human consumption. A package label, combined with the labeling requirements for products that must meet the lead free requirements (
The products specifically listed as exempt in SDWA section 1417(a)(4)(B) would not be subject to these labeling requirements or any of the other requirements of this proposal. These products are exempt from the requirements of this proposal: Toilets, bidets, urinals, fill valves, flushometer valves, tub fillers, fire hydrants, shower valves, service saddles or water distribution main gate valves that are 2 inches in diameter or larger.
In addition to the specific plumbing devices excluded in the SDWA, EPA is also proposing to exclude clothes washing machines, fire suppression sprinklers, eyewash devices, sump pumps and emergency drench showers, because EPA is not aware of any potable use for these specific products.
EPA solicits comments on all aspects of the proposed approach set forth above. EPA specifically solicits comments, information and data on the following topics:
1. This proposal includes two methods of qualifying for the “used exclusively for non-potable exemption:” (a) the product is physically incompatible with potable water systems, or (b) the packaging is clearly labeled that it is not for use for water for human consumption. Are the criteria listed above appropriate for qualifying for the “used exclusively” exemption or are there different or additional criteria that EPA should consider?
2. Is there any reason EPA should not extend the used exclusively for non-potable services exemption to plumbing products that are physically compatible with drinking water systems?
3. Will labeling the packaging of pipes, fittings or fixtures as not for use for water for human consumption be sufficient to inform consumers of the appropriate use of the product?
4. In addition to the specific plumbing devices excluded in the SDWA, EPA is also proposing to exclude clothes washing machines, fire suppression sprinklers, eyewash devices, sump pumps and emergency drench showers. EPA is not aware of a potable use for these devices, or of a potable use product that they could be confused with; and as such, requiring a label to qualify for the “used exclusively” exemption could be redundant and unnecessary for those devices. Is EPA's assumption about the lack of a potable use for these specific plumbing devices appropriate?
5. Are there other specific plumbing devices for which there are no potable uses, nor a potable use product they could be confused with that should be added to the list of excluded products?
6. EPA is proposing to retain the exemption for leaded joints used in the repair of cast iron pipes. EPA interprets the introduction into commerce provision as not prohibiting the sale or distribution of lead which may be used to form leaded joints used in the repair of cast iron pipes. Congress did not remove the statutory exemption for these types of repairs in section 1417(a)(1)(B) in either the 1996 or the 2011 amendments to section 1417 of the SDWA. Therefore, EPA believes that Congress intended to continue to allow the use of leaded joints necessary for the repair of cast iron pipes. EPA is seeking comment on this interpretation of section 1417(a)(1)(B).
EPA is proposing certification requirements for manufacturers and importers to demonstrate the maximum lead content of the wetted surfaces of their plumbing products do not exceed a weighted average of 0.25 percent using the method for the calculation of lead content established in the statute by either third party certification bodies or self-certification. For products that are required to meet Section 1417's lead free requirements, EPA proposes to require manufacturers with 100 or more employees or importers representing foreign manufacturers with 100 or more employees to demonstrate compliance with the lead free definition by obtaining third party certification by an American National Standards Institute (ANSI) accredited third party certification body. EPA proposes to require manufacturers with fewer than 100 employees or importers representing foreign manufacturers with fewer than 100 employees to demonstrate compliance either through third party certification by an ANSI accredited certification body or through self-certification as described below.
Third party certification is currently required for certain products in widely adopted model plumbing codes. The most recent version of the single most widely adopted model plumbing code requires pipe, pipe fittings, joints, values, faucets and fixture fittings used to supply water for drinking or cooking purposes to comply with the NSF/ANSI 372 standard for lead content. To meet the NSF/ANSI 372 standard, a product must be evaluated by an ANSI accredited third party certification body. These are independent organizations that test a product, review a product's manufacturing process and determine that the product complies with specific standards for safety, quality, sustainability or performance (i.e., NSF/ANSI 372 standard for lead content). ANSI accredited third party certification bodies currently include NSF International, CSA Group, ICC Evaluation Services, International Association of Plumbing and Mechanical Officials Research & Testing (IAPMO R&T), Intertek Testing Services, Truesdail Laboratories, Underwriters Laboratories and Water Quality Association.
For manufacturers with fewer than 100 employees and importers sourcing products from or representing foreign manufacturers with fewer than 100 employees, the proposed rule provides the flexibility of allowing these entities to demonstrate product compliance by either using an ANSI accredited third party certification body or by self-certification of the products. EPA estimated that manufacturers of covered products having fewer than 100 employees account for 72 percent of the total number of such manufacturers, but only produce 5 to 18 percent of the total volume of products. Small manufacturers that opt for the self-certification option would be required to develop a “certificate of conformity,” also known as a declaration of conformity, to attest that products meet the lead free requirements. A similar concept is currently in use for certain products regulated by the Federal Communications Commission and the Consumer Products Safety Commission.
For manufacturers or importers electing to self-certify products, the proposed rule would require the manufacturer to post the certificate of conformity on a Web page with continuing public access in the United States.
As proposed, the certificate of conformity would be required to include: Contact information for the manufacturer and any importer, a listing of products, statements attesting that the products meet the lead free requirements and that the manufacturer's or importer's eligibility to self-certify the product is consistent with the regulation (
The proposed certification requirements will further reduce the likelihood that non-lead free products will either intentionally or inadvertently be placed into commerce or used in the repair or installation of any public water system or any plumbing in a facility providing water for human consumption. In addition, the labeling and the certification requirements will assist in the enforcement of the SDWA section 1417(a)(3) prohibition of the introduction into commerce of pipes, pipe or plumbing fittings or fixtures that are not lead free. A third party certification requirement leverages the
As an alternative to the proposed product certification requirements previously described, EPA considered requiring all manufacturers to obtain third party certification for products required to meet the lead free requirements. A uniform third party certification requirement would result in a level playing field for all manufacturers and would also make the marketplace consistent when a consumer is shopping for pipes, fittings or fixtures. EPA is not proposing this option because we are concerned about the economic impacts of a mandatory third-party certification requirement on manufacturers with fewer than 100 employees. Some of these manufacturers likely produce or fabricate small quantities of products that may be custom-made for a single specific use with a customer. A requirement for third party certification in these instances may be impractical and costly per unit produced. For those reasons, EPA chose the approach described in this proposal.
EPA also considered the option of allowing all manufacturers the option of electing third party certification or self-certification for their various products. This option would allow maximum flexibility for manufacturers and would likely limit financial impacts to firms that currently do not get their products independently certified. EPA opted not to propose this approach because we found that (currently) the most widely used model plumbing codes require many products to be third party certified, and that there already exists a high level of adoption of third party standards in the plumbing industry. Additionally, requiring all but the smallest firms to certify their products using third party certification bodies would ensure that the vast majority of products sold in the marketplace are independently verified as lead free.
EPA solicits comments on this aspect of the proposed rule, including EPA's rationale as described in this preamble. In addition, EPA specifically solicits comments, information and data on the following topics:
1. Should third party certification be required of U.S. manufacturers regardless of the number of employees?
2. Should U.S. manufacturers have the option of conducting either third party certification or self-certification for products they produce?
3. Is there a need for some manufacturers to have a self-certification option?
4. Should third party certification be required of importers of foreign manufactured plumbing materials regardless of the number of employees at the foreign manufacturer?
5. Is there a more appropriate break point (
6. Conversely, should all importers of foreign manufactured plumbing products be eligible for self-certification?
7. Is the definition of importer in § 143.11 of this proposed rule adequate to ensure compliance with the proposed requirements?
8. Are there more appropriate criteria for requiring third party certification for manufacturers based on classes of products that EPA should evaluate, such as more complicated multi-component devices (for example, valves, faucets, pumps, water coolers, etc.), but allowing an option of self-certification for simple single component plumbing pieces (for example, elbow joint, gasket, pipe, etc.); or alternatively, based on whether a product is mass produced or custom fabricated?
9. Should self-certification be allowed for all products made by any manufacturer if the product is composed of a single material such as pure copper?
10. For self-certification, is the requirement for a “certificate of conformity” and its proposed content appropriate, or should there be another process for self-certification or is there other content for the “certificate of conformity” that would be more appropriate?
11. Should any product certification be required?
In order to effectively enforce the lead free requirements of the SDWA and the proposed implementing regulations, EPA needs the ability to obtain, if necessary on a case-by-case basis, certain compliance related information from manufacturers, importers, wholesalers and retailers and others subject to SDWA section 1417, such as information related to the calculation of the weighted average of wetted surfaces, schematics of fittings/fixtures, certification documentation, purchases/sales dates, and examples of lead free product and/or package messaging. This proposed rule contains a provision providing the EPA Administrator with explicit authority to request such information on a case-by-case basis and a requirement for entities to provide the information requested to the Administrator. This provision is based on statutory authority contained in section 1445 of the SDWA.
EPA is proposing language in § 143.14 to codify in regulation that the SDWA 1417(b) requirement for states to enforce the use prohibition on pipe, pipe fittings or fixtures, any solder, or any flux that are not lead free is a condition of receiving a full Public Water System Supervision grant allocation. Under SDWA 1417(b)(1), the state enforcement provision only applies to the use prohibition in section 1417(a)(1); it does not apply to the introduction into commerce prohibition in section 1417(a)(3) of the SDWA, nor would it apply to the proposed requirements for labeling and certification.
The revised definition of lead free has been in effect since January 4, 2014, as per the RLDWA and the CFSA. EPA is proposing that labeling and the product certification requirements contained within this proposal will be in effect three years from the date the final regulation is published, consistent with the three-year time period provided under the RLDWA and CFSA. EPA is also proposing that all other provisions are effective 30 days after the date the final regulation is published, because those provisions merely codify statutory provisions already in effect.
EPA solicits comments on all aspects of the proposed implementation period for this proposed rule. EPA specifically requests comments, information and data on whether three years is an appropriate timeframe to achieve compliance with the proposed labeling and certification requirements, or is a different timeframe more appropriate? Is there a need for a different effective date for any other provisions of the rule?
EPA collected data from public sources and private data vendors to develop the estimated rule costs to plumbing manufacturing firms. Annual
EPA developed cost estimates for this proposed rule along with two additional regulatory alternatives EPA considered in the development of the proposal. All three regulatory options contain estimates for initial administrative and implementation costs, costs to modify their product and/or package messaging, third party or self-certification costs, and response to data request costs. The three options are presented in Table V.3. Option B is the regulatory option selected for this proposal. The Technical Support Document (USEPA, 2016) provides more detailed information on the costing methodology and a discussion of the uncertainties and limitations of this assessment.
The analysis for initial administrative and implementation costs was conducted at the level of the manufacturing firm. These costs do not vary by regulatory option. EPA estimated that it would take each firm an average of 8 hours to read and understand the rule once promulgated. This time estimate when multiplied by an average labor rate of $71.72 and the number of firms affected by the rule, 2,193, gives a total cost of $1.26 million.
EPA also estimated the cost to manufacturing firms that would have to redesign their product and/or package messaging to include lead-related information. To calculate the cost of package and product messaging redesign, EPA first estimated the total number of product types across 46 product subcategories. A total of 5,705 product types were identified. EPA estimated a percent range of firms that would be required to redesign their product and package in order to comply with this proposed rule. Firms with greater than 500 employees are estimated to redesign 10 percent of product and package messaging. Manufacturers with fewer than 500 employees are assumed to redesign between 25 and 50 percent of their product and package messaging. Redesign was estimated to require 5 hours of labor multiplied by the number of products, giving a total costs range between $0.24 and $0.47 million.
Table V.4 summarizes, by size category, the initial rule implementation annualized cost ranges. The values were discounted at both the 3 and 7 percent rates over the 25-year period of analysis. Annual total initial implementation costs range from $0.08 to $0.14 million.
In order to estimate the potential cost of this proposed rule and the two alternative regulatory scenarios presented in this proposed rule preamble, EPA collected information on current labeling practices to set the regulatory baseline. EPA developed three baseline scenarios characterizing the proportion of firms by size category that either currently have lead free labeling (meeting the requirements of this proposed rule), have product messaging not related to lead free requirements, or have no product messaging. These three scenarios capture the uncertainty surrounding EPA's understanding of current industry labeling practices. Table V.5 presents preexisting labeling assumptions that represent the lower bound for regulatory cost estimates. Table V.6 shows a possible lower level baseline of product labeling. This table represents the upper bound for rule cost estimate. Across both lower and upper bound scenarios, EPA has made the conservative assumption that 5 percent of all firms have no messaging on product or package. Also common across the scenarios, is the concept that firms with greater numbers of employees have larger production totals and serve larger market areas and, therefore, will have a higher probability of selling in markets that already require lead content labeling on product and package. The upper bound scenario assumes manufacturers with fewer than 500 employees mark products with lead content messaging 50 percent of the time, while in the lower bound scenario, those same firms label 75 percent of products with lead content messaging. Also, firms in the upper bound scenario with less than 100 employees mark 50 percent of their packaging with lead content labeling. The lower bound assumes that firms with fewer than 100 employees label 75 percent of packaging with lead content information.
Using the assumptions on current industry messaging practices detailed in Tables V.5 and V.6, EPA applied its unit compliance technology costs for both product and package labeling in the following way: (1) Firms that currently have lead content messaging on both product and package are assumed to have no labeling costs in this regulatory analysis; (2) manufacturers that currently mark their product and/or package with some messaging (
Under regulatory options requiring lead free marking on potable use products, EPA assigned to each of the 40 identified product subcategories one of three compliance technologies: Printing on product (
For regulatory costing scenarios that required lead free labeling on product packages, EPA (again) assigned one of three compliance technologies to each of the 40 potable use product categories. The compliance technologies are printing on product box (
Unit capital and O&M costs for each of the six compliance technologies were derived with information collected from both the PMI and AFS trade associations and information from tool and die firms, product packaging vendors, and printing equipment suppliers.
Table V.7 provides EPA's estimated total annual cost ranges for potable use product lead free messaging on product and/or package for the three options considered as part of the regulatory analysis. For Options A and B, costs include labeling on both the product and package and range from $8.69 to $13.60 million (2014$) dollars annually. For Option C, which gives producers the choice to label the product or package, EPA assumed that impacted firms would choose the lower cost package labeling alternative; therefore, annual costs range from $1.14 to $1.28 million dollars.
As discussed in section IV.C, EPA has included an additional means of qualifying for the “used exclusively” exemption.
The proposed provision to label products to establish that the products are “used exclusively” in nonpotable services provides a less costly option to persons introducing the product into commerce. If the proposed regulations limited the availability of the “used exclusively” exemption to products that are physically incompatible with potable water systems, then persons introducing non-potable water plumbing products into commerce that are physically compatible and capable of being connected to systems providing water for human consumption would be required to assure that these products meet the lead free requirements. Alternatively, they could or redesign their products to make them physical incompatible with potable water systems. EPA anticipates that the costs associated with designing and applying a label are likely to be less than the costs associated with reformulating the alloy and overhauling the manufacturing processes associated with meeting the “lead free” requirements. Therefore, this optional compliance alternative will not result in increased costs or burden, and will result in a cost savings for those manufacturers who elect to take advantage of this proposed optional exemption mechanism.
There are six product subcategories that are both physically compatible with potable use applications and would meet the lead content limit of 0.25 percent of wetted surfaces to be considered lead free. In order to develop costs for this requirement EPA first determined the baseline current industry practices when it comes to labeling products eligible for the “used exclusively” exemption and their packaging. Table V.8 shows the lower bound percentage of products by firm size category that currently use lead content messaging, messaging of some kind (
EPA assumed manufacturers of products eligible for the “used exclusively” exemption that currently do not have lead-related information on their product would use the same compliance technologies that would be used for the labeling of potable use products and packages. For labeling on the product, EPA assigned each of the subcategories as either the printing on product or the mold modification compliance technology.
EPA used the same unit cost information that was developed for the potable use labeling requirements. Table V.10 details, by size category, the regulatory annual total cost ranges for labeling those products eligible for the “used exclusively” exemption not for potable use applications. This cost component does not vary by regulatory option. Annual total cost for labeling products that are not for potable use range from $0.14 to $0.22 million.
In order to develop total compliance costs for third party certification, EPA had to determine the regulatory baseline. This baseline represents the current industry practice with regard to third party certification. EPA collected information on use of third party certification by plumbing manufacturers by reviewing current state laws requiring certification for NSF Standard 61 and 372; reviewing the International and Uniform Plumbing Codes; contacting the two primary industry trade groups, PMI and AFS; and acquiring information from industry third party certifiers (
Third party certifying firms usually conduct the certification process according to product families. For NSF/ANSI Standard 372, products of the same material formulation and similar configuration are considered one product family. Thus, certifying costs were developed on a product family basis. EPA estimated that each firm produces an average of three product families, based on an assessment of firm Web site data for manufacturers across all potable use product subcategories.
Certification costs can be broken into initial assessment and testing costs and annual renewal costs. Most of the accredited third party certification bodies offer an annual renewal based on an audit process for a set number of years after the initial certification year. In order to derive initial and renewal certification unit costs, EPA contacted the eight ANSI accredited third party certification bodies to obtain estimated costs for certifying products to ANSI/NSF Standard 372. The certifiers were asked to provide estimates for four representative product categories (faucets, fittings, valves and pipes), which are intended to represent the range in complexity of plumbing products.
Four certification bodies provided quotes of sufficient specificity or comparable scope to be used in estimating initial certification costs. None of the firms provided quotes for all four product lines. Costs varied based on the product type and certifying body. EPA used the average of these quotes across firms and product types to derive a composite estimated cost of $6,000 for an initial certification of a single product family. Five of the eight certification bodies provided estimates for annually renewing the third party certification to Standard 372. Costs varied based on the product type and certification body. One of the responding certifiers requires re-certification annually. The other four certification bodies require renewal on a less frequent basis, the longest being every five years. EPA determined a five-year cost stream for each of the third party certifiers and computed a per product family average annual renewal cost of $3,200. In addition to the certifiers' fees, EPA assumed a $224 annualized cost for recordkeeping on the part of the plumbing manufacturing firms.
Both the preferred proposed rule Option B and Option C allow for some firms to self-certify compliance with lead free requirements. EPA estimated that each manufacturer would require 40 hours of labor to initially develop the certificate of conformity (the requirement of the certificate of conformity can be found in section IV.D of this preamble) which certifies a product family as being compliant with the lead free requirements. The unit cost per product family is $1,122. The labor burden for the annual renewal of the self-certification per product family is estimated to be 16 hours. These hours are used to update the certificate of conformity and perform recordkeeping activities. This means the unit cost of annual self-recertification is $449 per product family.
Table V.12 provides EPA's estimated total annual cost ranges for potable use product certification requirements of this proposed rule and other options that were considered. Unit certification costs were multiplied by the number of firms and average number of product families. Option A's cost range of $11.20 to $21.58 million reflects a third party certification requirement for all regulated firms. Option B, the proposed option, requires third party certification for firms with 100 or more employees and gives the option of self-certification to firms with fewer than 100 employees. Annual costs for Option B range from $2.82 to $4.31 million. The analysis of Option C assumes that all firms, when given the less costly self-certification choice, will opt for that compliance path. Therefore, the annual costs that range from $1.52 to $2.98 million reported here are for all firms conducting self-certifications. EPA did not assess any cost savings to firms that would no longer choose to have products third party certified.
Under all three of the proposed regulatory options, plumbing manufacturers will be required to respond to EPA's requests for product information (See section IV.E.1.a for a detailed description of the data request provision). EPA assumed that firms would spend an average of 20 hours responding to each data request, resulting in a unit cost of $1,434. As part of the cost assessment, EPA multiplied the per unit cost by 10 unique data requests per year, starting in the fourth year after promulgation of the final rule and continuing over the 25-year period of analysis. Seventy percent of requests would be to firms with 500 or more employees, 20 percent of requests would be to firms with 100 to 499 employees, and firms with fewer than 100 employees would receive the remaining 10 percent. This breakdown of requests between firm size categories roughly corresponds to the proportion of total products produced by firms in each of the size categories. Table V.13 shows the total annualized cost of EPA data request response by firm size category. Total data request costs range from approximately $12,400 a year discounted at 3 percent to about $11,900 a year when discounted at 7 percent.
EPA assessed the social costs and the projected economic impacts of the three regulatory options described in this proposal. This section provides an overview of the methodology EPA used to assess the social costs and the economic impacts of this proposed rule and summarizes the results of these analyses. The Technical Support Document (USEPA, 2016), which is available in the docket, provides more details on these analyses, including discussions of uncertainties and limitations.
EPA estimated the total annualized social costs to plumbing manufacturers by summing the rule's component costs, which include administrative requirement costs, the cost to potable use product manufacturers for both labeling on the product and on the product's packaging, the cost to manufacturers of products eligible for the “used exclusively” exemption for package labeling indicating non-compliance with lead free requirements, third party- and self-certification costs, and the costs of responding to EPA data requests. EPA annualized the stream of future costs using both the 3 percent (the social discount rate) and 7 percent (opportunity cost of capital) discount rates. EPA annualized one-time costs over the period of analysis, 25 years. Capital and O&M costs recurring on other than an annual basis were annualized over a specific useful life, implementation, and/or event recurrence period (
Table VI.1 presents the total annualized compliance costs of the regulatory options. As shown in the table, total annualized compliance costs range between $3 million and $36 million for Options C and A, respectively, with the proposed option (Option B) estimated to have annualized costs of $12 million to $18 million.
To provide an assessment of the impact of the rule on plumbing manufacturing firms, EPA used a cost-to-revenue analysis. The cost-to-revenue analysis compares the total annualized compliance cost of each regulatory option with the revenue of the impacted entities. This same analysis is also used under the Regulatory Flexibility Act (RFA) to determine if a rule has the potential to have a significant impact on a substantial number of small entities.
In order to conduct the cost-to-revenue test, EPA developed a list of 2,193 manufacturers that participate in the production of specific types of plumbing products for both potable use and those eligible for the “used exclusively” exemption. These firms were assigned to a NAICS code, based on the type of plumbing product they manufacture. Firm size distributional information, based on number of employees, available from the U.S. Census Bureau's Statistics of U.S. Businesses for the year 2012 was then used to parse the number of entities in each NAICS code into a number of small business and large firm categories. In this way, the number of firms in each of the 14 NAICS codes having seven employee size categories each (
EPA then compared the computed average annual costs to the average revenue for each of the NAICS/employee size categories. If average cost exceeded revenue by 1 percent, all firms assigned to that category were assumed to incur impacts. Likewise, if average annual cost exceeded revenue by 3 percent in a NAICS/employee size category, all entities in that category are assumed to be impacted at the 3 percent level. Impacted firms are summed across NAICS codes and employee size categories to assess the total impact to the industry.
Table VI.2 summarizes the cost-to-revenue analysis results for the three main regulatory options. The table only shows the largest impact scenarios analyzed, based on upper bound compliance cost estimates, and using a 7 percent discount rate. For the lower bound cost and 3 percent discounted impact results see the Technical Support Document (USEPA, 2016). Under Option B, which represents this proposed rule (which includes costs for rule implementation, potable use labeling costs for both package and product, labeling of products eligible for the “used exclusively” exemption that do not meet lead free requirements, third party certification cost for firms with 100 or more employees and third party or self-certification costs for firm with fewer than 100 employees, and data request costs), EPA estimates that the vast majority of plumbing manufacturing firms subject to the regulations will incur annualized costs amounting to less than 1 percent of revenue (2163 firms, or 98.6 percent of the total 2,193 manufacturers). A total of 29 firms (2 percent of small firms) had impacts between 1 and 3 percent of revenue, and no small manufacturers had impacts above 3 percent, given the costs estimated for Option B. The analysis of Option B also found that 1 large entity (0.5 percent of large firms) had impacts between 1 and 3 percent of revenue, and no large firms were impacted at the 3 percent revenue threshold.
EPA solicits comments on the economic analysis for this proposed rule, including EPA's cost analysis and benefits assessment as described in this preamble and the Technical Support Document (USEPA, 2016) for this proposed rule. Comments are most helpful when accompanied by specific examples or supporting data.
EPA did not quantify the expected change in health endpoints for this proposed regulation. EPA assessed the health effects associated with reductions in lead ingestion qualitatively using two main sources: (1) The EPA “Integrated Science Assessment for Lead” (USEPA, 2013b); and (2) the National Toxicity Program's Monograph on Health Effects of Low-level Lead (USHHS, 2012).
A wealth of information exists on the adverse health effects associated with lead exposure. When ingested, lead is distributed throughout the body and can affect many organ systems. Lead is a highly toxic contaminant that can cause adverse neurological, cardiovascular, renal, reproductive, developmental, immunological and carcinogenic effects. The neurological effects are particularly pronounced in children; however, recent studies in the public health literature have found that a wide spectrum of adverse health outcomes can occur in people of all ages. In 2013, the U.S. Burden of Diseases Collaborators identified lead as one of the top 15 mortality risk factors (and top 10 cardiovascular risk factors) in the country. In addition, a level of lead exposure below which adverse effects do not occur has not been identified. This suggests that further declines in lead exposure below current-day levels could still yield meaningful benefits in the U.S. population, and the reduction in lead exposures from this proposed rule would result in fewer adverse health outcomes and, in turn, decrease societal costs of treatment. Chapter 5 of the Technical Support Document (USEPA, 2016) for this proposed rule contains additional detailed information on the potential health impacts of lead on both children and adults.
This action is not a significant regulatory action and was therefore not submitted to the Office of Management and Budget (OMB) for review.
The information collection activities in this proposed rule have been submitted for approval to the Office of Management and Budget (OMB) under the PRA. The Information Collection Request (ICR) document that EPA prepared has been assigned EPA ICR No. 2563.01. You can find a copy of the ICR in the docket for this rule, and it is briefly summarized here.
The PRA requires EPA to estimate the burden on manufacturers and primacy agencies of complying with the proposed rule. The information collected as a result of this proposed rule should allow EPA to determine appropriate requirements for specific manufacturers and evaluate compliance with the proposed rule. For the first three years after publication of the final rule in the
• Obtaining certification of products from an accredited third party certification body to document compliance with the lead free requirements as set forth in the SDWA.
• Maintaining record costs associated with the initial certification (conducted by an accredited third party certification body) that potable use products meet the requirements of NSF/ANSI Standard 372.
• Preparing the initial certificate of conformity and maintaining records for potable use products that are self-certified by the manufacturer as being lead free.
An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. The OMB control numbers for EPA's regulations in 40 CFR are listed in 40 CFR part 9.
Submit your comments on EPA's need for this information, the accuracy of the provided burden estimates and any suggested methods for minimizing respondent burden to EPA using the docket identified at the beginning of this rule. You may also send your ICR-related comments to OMB's Office of Information and Regulatory Affairs via email to
I certify that this action will not have a significant economic impact on a substantial number of small entities under the RFA. The small entities subject to the requirements of this action are the manufacturing firms involved in the production of pipe, pipe or plumbing fitting or fixture, flux or solder, which are utilized in public water system or any plumbing in a residential or nonresidential facility or location that provides water for human consumption that meet the SBA's size standards for small businesses. Firms providing these types of plumbing products span fourteen different North American Industrial Classification System (NAICS) categories. The SBA small business definitions used in the analysis of this proposed rule vary across NAICS categories and range from firms with fewer than 500 employees to firm's with fewer than 1,250 employees (See Table XII.1).
EPA has determined that 1,976 plumbing product manufacturers out of 2,193 plumbing product manufacturers potentially subject to this proposal meet the small business definitions. EPA's analysis of projected impacts on small entities is described in detail in section VII (Economic Impacts). EPA projects less than 2 percent of the 1,976 affected small entities may experience an impact of costs exceeding 1 percent of revenue and no small entities would incur compliance costs exceeding 3 percent of revenue. Details of this analysis are presented in Chapter 6 of the Technical Support Document, available in the docket, for the proposed rule.
This action does not contain an unfunded mandate of $100 million or more as described in UMRA, 2 U.S.C. 1531-1538, and does not significantly or uniquely affect small governments. The proposed rule places no federal mandates on state, local, or tribal governments. The mandated annual cost to the private sector is estimated to be between $11.8 and $18.3 million and the highest single year nominal cost is $53.4 million which is below the $100 million UMRA threshold.
This action does not have federalism implications. It will not have substantial direct effects on the states, on the relationship between the national government and the states, or on the distribution of power and responsibilities among the various levels of government.
This action does not have tribal implications as specified in Executive Order 13175. It would not have substantial direct effects on tribal governments, on the relationship between the federal government and Indian Tribes, or on the distribution of power and responsibilities between the federal government and Indian Tribes. This proposed rule contains no federal mandates for tribal governments and does not impose any enforceable duties on tribal governments. Thus, Executive Order 13175 does not apply to this action.
The EPA interprets Executive Order 13045 as applying only to those regulatory actions that concern environmental health or safety risks that the EPA has reason to believe may disproportionately affect children, per the definition of “covered regulatory action” in section 2-202 of the Executive Order. This action is not subject to Executive Order 13045 because it implements specific standards established by Congress in statute. While the executive order does not apply, EPA does anticipate that the labeling requirements associated with
This action is not subject to Executive Order 13211, because it is not a significant regulatory action under Executive Order 12866.
This action involves technical standards. The EPA is proposing a requirement that can be satisfied by, depending on the size of the regulated entity, either self-certifying compliance with the SDWA lead prohibition or by achieving a voluntary standard that mirrors the SDWA requirements, such as the NSF/ANSI 372 standard. While EPA is not specifying a technical standard under this proposed rule, EPA is proposing the use of technical standards that will meet the new definition of lead free as a means of demonstrating compliance with this proposal.
EPA has determined that this action will not have disproportionately high and adverse human health or environmental effects on minority populations, low-income populations, or indigenous peoples as described in Executive Order 12898 (59 FR 7629, February 16, 1994), because this action does not establish any specific regulatory requirements that would affect these communities. Instead, it is a proposed rule that codifies existing requirements set forth by Congress regarding the allowable levels of lead in plumbing products, and also includes additional provisions intended to aid in the implementation of those requirements.
Environmental protection, Chemicals, Indian—lands, Intergovernmental relations, Radiation protection, Reporting and recordkeeping requirements, Water supply.
Environmental protection, Chemicals, Indian—lands, Water supply.
For the reasons set forth in the preamble, EPA proposes to amend title 40 chapter I of the Code of Federal Regulations parts 141 and 143 as follows:
42 U.S.C. 300f, 300g-1, 300g-2, 300g-3, 300g-4, 300g-5, 300g-6, 300j-4, 300j-9, and 300j-11.
42 U.S.C. 300f
The following definitions apply to this subpart:
(a) “Lead free” for the purposes of this subpart means:
(1) Not containing more than 0.2 percent lead when used with respect to solder and flux; and
(2) Not more than a weighted average of 0.25 percent lead when used with respect to the wetted surfaces of pipes, pipe fittings, plumbing fittings, and fixtures.
(b) The weighted average lead content of a pipe, pipe fitting, plumbing fitting, or fixture is calculated by using the following formula: For each wetted component, the percentage of lead in the component is multiplied by the ratio of the wetted surface area of that component to the total wetted surface area of the entire product to arrive at the weighted percentage of lead of the component. The weighted percentage of lead of each wetted component is added together, and the sum of these weighted percentages constitutes the weighted average lead content of the product. The lead content of the material used to produce wetted components is used to determine compliance with paragraph (a)(2) of this section. For lead content of materials that are provided as a range, the maximum content of the range must be used.
(c) If a coating, as defined in § 143.11, is applied to the internal surfaces of a pipe, fitting or fixture component, the maximum lead content of both the coating and the alloy must be used to calculate the lead content of the component.
(d) If a liner, as defined in § 143.11, is manufactured into a pipe, fitting or fixture, the maximum lead content of the liner must be used to calculate the lead content of the component.
(a) No person may use any pipe, any pipe or plumbing fitting or fixture, any solder or any flux that is not lead free as defined in § 143.12 in the installation or repair of:
(1) Any public water system; or
(2) Any plumbing in a residential or nonresidential facility providing water for human consumption.
(b) Paragraph (a) of this section shall not apply to leaded joints necessary for the repair of cast iron pipes.
As a condition of receiving a full allotment of Public Water System Supervision grants under section 1443(a) of the Safe Drinking Water Act, states must enforce the requirements of section 1417(a)(1) of Safe Drinking Water Act and § 143.13 through state or local plumbing codes, or such other means of enforcement as the state may determine to be appropriate.
It shall be unlawful:
(a) For any person to introduce into commerce any pipe, or any pipe or plumbing fitting or fixture, that is not lead free, except for a pipe that is used in manufacturing or industrial processing;
(b) For any person engaged in the business of selling plumbing supplies in the United States, except manufacturers, to sell solder or flux that is not lead free; and
(c) For any person to introduce into commerce any solder or flux that is not lead free unless the solder or flux bears a prominent label stating that it is illegal to use the solder or flux in the installation or repair of any plumbing providing water for human consumption.
The prohibitions in §§ 143.13 and 143.15 shall not apply to the products listed in paragraphs (a) through (c) of this section:
(a) Pipes, pipe fittings, plumbing fittings, or fixtures, including backflow preventers, that are used exclusively for nonpotable services such as manufacturing, industrial processing, irrigation, outdoor watering, or any other uses where the water is not anticipated to be used for human consumption. For the purposes of this subpart, “used exclusively for nonpotable services” means:
(1) The product is incapable of use in potable services (
(2) The product is clearly labeled, on the product, package, container, or tag with a phrase such as: “Not for use with water for human consumption” or another phrase that conveys the same meaning in plain language.
(b) Toilets, bidets, urinals, fill valves, flushometer valves, tub fillers, shower valves, fire hydrants, service saddles, water distribution main gate valves that are 2 inches in diameter or larger.
(c) Clothes washing machines, fire suppression sprinklers, eyewash devices, sump pumps, and emergency drench showers.
(a) Persons that introduce into commerce products that must meet the lead free requirements of section 1417(a)(3)(A) of the Safe Drinking Water Act and § 143.12 must label such products to indicate that it is in compliance with those requirements. Such labeling must occur by [DATE 3 YEARS AFTER PUBLICATION OF FINAL RULE IN THE
(b) Labeling or marking as specified in paragraph (a) of this section must be in accordance with paragraphs (b)(1), (b)(2), and (c) of this section:
(1) Packaged, containerized or tagged products must be labeled or marked on the package, container, or tag with a phrase such as: “Conforms with the lead free requirements of the federal Safe Drinking Water Act,” “Lead Free,” or similar terms that clearly convey to users that the product is in compliance with the applicable requirements. Products that are not packaged, containerized or tagged are only required to be marked consistent with requirements in paragraph (b)(2) of this section. Shrink wrapping of bulk products solely for the purpose of shipping or storage does not constitute being packaged, containerized, or tagged.
(2) Products must be directly marked by physically stamping, forging, or printing with indelible ink, except as provided in (b)(2)(i) or (b)(2)(ii) of this section. The marking must clearly convey to consumers that the product is lead free, such as “Lead Free,” “LF,” or certification marks. If the marking is “LF” or another abbreviation, symbol or acronym, the product package, container, or tag must associate that marking with a phrase such as “lead free” or “meets lead free requirements.” Product markings should be located where they are visible after product installation when practical.
(i) If the product is too small for a legible marking in a type face ranging from approximately 8 point to 14 point depending on the method of marking and roughness of product surface, only a product package, container or tag must be labeled or marked.
(ii) If the visible marking on installed products will adversely impact the visual appeal to consumers of the finished product, the product may be marked in a location not visible after installation.
(c) For products certified by accredited third party certification bodies, labeling or marking on the product, package, container, tag or some combination of these locations must include:
(1) The logo or name of the certification body as specified by the specific certification body; and
(2) The specific certification body's required identifier text to convey lead free or low lead content.
Solder and flux that is not “lead free” as defined in § 143.12(a)(1) must bear a prominent label stating that it is illegal to use the solder or flux in the installation or repair of any plumbing providing water for human consumption.
(a) Manufacturers or importers that introduce into commerce products that must meet the lead free requirements of section 1417 of the Safe Drinking Water Act and § 143.12 must ensure that the products are certified to be in compliance as specified in paragraphs (b) and (c) of this section by [DATE 3 YEARS AFTER PUBLICATION OF FINAL RULE IN THE
(b) Certification of products must be obtained by manufacturers or importers from an accredited third party certification body, except as provided in paragraph (c) of this section.
(1) Products certified by an accredited third party certification body must be labeled or marked as specified in § 143.17(c).
(2) The manufacturer or importers must keep records for all products certified by an accredited third party certification body that include at a minimum: Documentation of certification, dates of certification and expiration. This documentation must be provided upon request to the Administrator as specified in § 143.20(b).
(c) Manufacturers having fewer than 100 employees or importers sourcing products from or representing manufacturers having fewer than 100 employees may elect to self-certify products in lieu of obtaining certification from an accredited third party certification body. The number of employees includes any persons employed by the manufacturer and any of its affiliated entities. The number of employees must be calculated by averaging the number of persons employed, regardless of part-time, full-time or temporary status by an entity and all of its affiliated entities for each pay period over the entity's latest 12 calendar months, or averaged over the number of months in existence if less than 12 months. Such manufacturers or importers electing to self-certify products must comply with paragraphs (d) through (g) of this section.
(d) In order for eligible manufacturers or importers to self-certify products, such manufacturers or importers must attest that products are in compliance by developing and maintaining a “certificate of conformity.” The certificate of conformity must be:
(1) Signed by a responsible corporate officer, a general partner or proprietor, or an authorized representative of a responsible corporate officer, general partner or proprietor; and
(2) Posted to a Web page with continuing public access in the United States.
(e) The certificate of conformity must be in English and include:
(1) Contact information for the manufacturer or importer to include:
(i) The entity or proprietor name,
(ii) Street and mailing addresses,
(iii) Phone number, and
(iv) Email address.
For products imported into the United States, the contact information must also be included for the manufacturer;
(2) A brief listing of the products to include, when applicable, unique identifying information such as model names and numbers;
(3) A statement attesting that the products meet the lead free requirements of the Safe Drinking Water Act and 40 CFR part 143, subpart B and also that the manufacturer or importer is eligible to self-certify the product consistent with this regulation;
(4) A statement indicating how the manufacturer or importer verified conformance with the Safe Drinking
(5) The signature, date, name and position of the signatory; and if the signatory is an authorized representative of a responsible corporate officer, a general partner or proprietor, the name and position of the responsible corporate officer, a general partner or proprietor.
(f) Manufacturers or importers that self-certify products must maintain, at a primary place of business within the United States, certificates of conformity and sufficient documentation to confirm that products meet the lead free requirements of this subpart. Sufficient documentation may include: Detailed schematic drawings of the products indicating dimensions, calculations of the weighted average lead content of the product, lead content of materials used in manufacture and other documentation used in verifying the lead content of a plumbing device. This documentation and certificates of conformity must be provided upon request to the Administrator as specified in § 143.20(b).
(g) The certificate of conformity and documentation must be completed prior to a product's introduction into commerce.
(a) Noncompliance with the Safe Drinking Water Act or this subpart may be subject to enforcement. Enforcement actions may include seeking injunctive relief, civil or criminal penalties.
(b) The Administrator may, on a case-by-case basis, request any information deemed necessary to determine whether a person has acted or is acting in compliance with section 1417 of the Safe Drinking Water Act and this subpart. Such information requested must be provided to the Administrator at a time and in a format as may be reasonably determined by the Administrator.
Environmental Protection Agency (EPA).
Proposed rule.
As required under section 6(b)(1) of the Toxic Substances Control Act (TSCA), EPA is proposing to establish a risk-based screening process and criteria that EPA will use to identify chemical substances as either High-Priority Substances for risk evaluation, or Low-Priority Substances for which risk evaluations are not warranted at the time. The proposed rule describes the processes for identifying potential candidates for prioritization, selecting a candidate, screening that candidate against certain criteria, formally initiating the prioritization process, providing opportunities for public comment, and proposing and finalizing designations of priority. Prioritization is the initial step in a new process of existing chemical substance review and risk management activity established under recent amendments to TSCA.
Comments must be received on or before March 20, 2017.
Submit your comments, identified by docket identification (ID) number EPA-HQ-OPPT-2016-0636, by one of the following methods:
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This proposed rule does not propose to establish any requirements on persons or entities outside of the Agency. This action may, however, be of interest to entities that are or may manufacture or import a chemical substance regulated under TSCA (
EPA is proposing to establish the internal processes and criteria by which EPA will identify chemical substances as either High-Priority Substances for risk evaluation, or Low-Priority Substances for which risk evaluations are not warranted at the time.
This rulemaking is required by TSCA section 6(b)(1)(A). Prioritization of chemical substances for further evaluation will ensure that the Agency's limited resources are conserved for those chemical substances most likely to present risks, thereby furthering EPA's overall mission to protect health and the environment.
EPA is proposing this rule pursuant to the authority in TSCA section 6(b), 15 U.S.C. 2605(b). See also the discussion in Units II.A and B.
This is a proposed rule that would establish the processes by which EPA intends to designate chemical substances as either High or Low-Priority Substances for risk evaluation. It would not establish any requirements on persons or entities outside of the Agency. EPA did not, therefore, estimate potential incremental impacts from this action.
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On June 22, 2016, the President signed into law the “Frank R. Lautenberg Chemical Safety for the 21st Century Act” (Pub. L. 114-182), which imposed sweeping reforms to TSCA. The bill received broad bipartisan support in the U.S. House of Representatives and Senate, and its passage was heralded as the most significant update to an environmental law in over 20 years. The amendments give EPA improved authority to take actions to protect people and the environment from the effects of dangerous chemical substances. Additional information on the new law is available on EPA's Web site at
When TSCA was originally enacted in 1976, it established an EPA-administered health and safety review process for new chemical substances prior to allowing their entry into the marketplace. However, tens of thousands of chemical substances in existence at that time were “grandfathered in” with no requirement for EPA to ever evaluate their risks to health or the environment. The absence of a review requirement or deadlines for action, coupled with a burdensome statutory standard for taking risk management action on existing chemical substances, resulted in very few chemical substances ever being assessed for safety by EPA, and even fewer subject to restrictions to address identified risks.
One of the key features of the new law is the requirement that EPA now systematically prioritize and assess existing chemical substances, and manage identified risks. Through a combination of new authorities, a risk-based safety standard, mandatory deadlines for action, and minimum throughput requirements, TSCA effectively creates a “pipeline” by which EPA will conduct existing chemical substances review and management. This new pipeline—from prioritization to risk evaluation to risk management (when warranted)—is intended to drive steady forward progress on the backlog of existing chemical substances left largely unaddressed by the original law. Prioritization is the initial step in this process.
TSCA section 6(b)(1) requires EPA to establish, by rule, the process and criteria for prioritizing chemical substances for risk evaluation. Specifically, the law requires EPA to establish “a risk-based screening process, including criteria for designating chemical substances as high-priority substances for risk evaluations or low-priority substances for which risk evaluations are not warranted at the time.” TSCA sections 6(b)(1) through (3) provide further specificity on both the process and criteria, including preferences for certain chemical substances that EPA must apply, the procedural steps, definitions of High-Priority Substances and Low-Priority Substances, and screening criteria that EPA must consider in designating a chemical substance as either High-Priority Substances or Low-Priority Substances. The statutory requirements related to prioritization are described in further detail in this unit.
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In designating the priority of a chemical substance, EPA must screen a candidate chemical substance against certain criteria specified in TSCA section 6(b)(1)(A). These include the hazard and exposure potential of the chemical substance (
The results of this screen will help inform EPA's proposed priority designation. However, given that the statutory deadlines are triggered at the initiation of prioritization, and that EPA will want to have a good understanding of the chemical substance before triggering those deadlines, EPA will consider these screening criteria earlier in the process. As discussed in more detail in Unit III., EPA is therefore proposing to include the screening review in the rule as part of the pre-prioritization phase.
In designating High-Priority Substances, EPA is to give preference to chemical substances that are listed in the 2014 Update of the TSCA Work Plan for Chemical Assessments (Ref. 1) that: (1) Have persistence and bioaccumulation scores of 3; and (2) are known human carcinogens and have high acute and chronic toxicity. 15 U.S.C. 2605(b)(2)(D). The law further requires that 50% of all ongoing risk evaluations be drawn from the 2014 Update to the TSCA Work Plan for Chemical Assessments, meaning that, at least at the outset of the program, EPA will need to draw at least 50% of High-Priority Substance designations from the same list. 15 U.S.C. 2605(b)(2)(B).
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A number of stakeholders raised questions as to whether EPA should define a number of important terms in this rule (
EPA believes further defining these and other terms in the proposed rule is unnecessary and ultimately problematic. These terms have and will continue to evolve with changing scientific methods and innovation. Codifying specific definitions for these phrases in this rule may inhibit the flexibility and responsiveness of the Agency to quickly adapt to and implement changing science. The Agency intends to use existing guidance definitions and to update definitions and guidance as necessary.
While EPA is seeking public comment on all aspects of this proposed rule, the Agency is specifically requesting public input on this issue. The Agency welcomes public comments regarding the pros and cons of codifying these or other definitions and/or approaches for these or any other terms. EPA encourages commenters to suggest alternative definitions the Agency should consider for codification in this procedural rule. Please explain your views as clearly as possible, providing specific examples to illustrate your concerns and suggest alternate wording, where applicable.
Prioritization of chemical substances for review is not a novel concept for the Agency. In 2012, EPA released the TSCA Work Plan Chemicals: Methods Document in which EPA described the process the Agency intended to use to identify potential candidate chemical substances for near-term review and assessment under TSCA (Ref. 4). EPA also published an initial list of TSCA Work Plan chemicals identified for further assessment under TSCA as part of its chemical safety program in 2012 (Ref. 5), and an updated list of chemical substances for further assessment in 2014 (Ref. 1). The process for identifying these chemical substances was based on a combination of hazard, exposure, and persistence and bioaccumulation characteristics.
Congress expressly recognized the validity of EPA's existing prioritization methodology for the TSCA Work Plan. For example, the law requires that EPA give certain preferences to chemical substances listed on the 2014 Update to the TSCA Work Plan. 15 U.S.C. 2605(b)(2)(D). Moreover, the law requires that at least 50 percent of all ongoing risk evaluations be drawn from the 2014 Update to the TSCA Work Plan. 15 U.S.C. 2605(b)(2)(B). The statutory screening criteria in TSCA section 6(b)(1)(A) also significantly overlaps with the considerations in the Work Plan methodology (
However, there are a number of key differences between EPA's TSCA Work Plan process and the prioritization process that TSCA now requires. First, the Work Plan process involved culling through thousands of chemical substances to create a list that EPA could, over time and without prescribed deadlines, focus its limited resources on. The TSCA Work Plan did not require EPA to assess listed chemical substances, and included no deadlines for completing risk assessments or addressing identified risks. Prioritization under this proposed rule will involve a similar culling, but upon designating a chemical substance as a High-Priority Substance, the Agency must start a risk evaluation, and generally complete that evaluation within a specified amount of time. If EPA determines in the risk evaluation that a chemical substance presents an unreasonable risk of injury to health or the environment, EPA must also initiate a risk management rulemaking subject to statutory deadlines. 15 U.S.C. 2605(c). As such, EPA will need to be judicious in selecting the chemical substances that go into prioritization.
Further, while chemical substances listed on the TSCA Work Plan were likely to be well-characterized for hazard and have at least some information indicating potential exposure, Work Plan chemical substance assessments have generally focused on specific chemical uses. Given the statutory deadlines, EPA generally intends to ensure it has a more complete set of data upfront that would allow EPA to evaluate a chemical substance under all conditions of use (a broader scope) within the statutory deadlines. For chemical substances with insufficient information to conduct a risk evaluation, EPA generally expects to pursue a significant amount of data gathering before initiating prioritization.
Finally, the TSCA Work Plan process focused solely on identifying potential high risk chemical substances for further review. Because the statute also requires the identification of Low-Priority Substances—those chemical substances that EPA has determined, based on sufficient evidence, do not warrant further review at the time—EPA will need to undertake new and different analyses than it has done to date under the TSCA Work Plan.
While EPA has drawn from the TSCA Work Plan methodology and EPA's experience in implementing that process in developing this proposed rule, EPA is proposing to tailor the process for prioritization to the specific requirements in the new statute.
On August 10, 2016, EPA held a one day public meeting to hear from stakeholders to better understand their viewpoints on the development of the prioritization rule. The meeting began with a presentation from EPA on how the Agency has prioritized chemicals for further review under the TSCA Work Plan methodology. The remainder of the day was reserved for public comment. Commenters had approximately four
Stakeholders were also able to provide written comments. EPA received 50 written comments on the prioritization rule, although many of those who presented orally also submitted written versions as well. These comments and a transcript of the meeting are accessible in the meeting's docket, identified by Docket ID No. EPA-HQ-OPPT-2016-0399, available online at
The commenters included representatives from industry, environmental groups, academics, private citizens, trade associations, and health care representatives, and provided a diversity of perspectives. Overall, there was a general expression of support for the new law and EPA's inclusive approach to implementation to date. Most groups agreed that the prioritization rule had the potential to increase transparency in EPA's chemical substance review and management process, and urged the Agency to work towards this goal.
A number of commenters suggested codifying specific details in the rule, such as a system for scoring and ranking chemical substances; a listing of the specific hazard and exposure information upon which EPA will base prioritization decisions; and definitions of terms referenced in the statute like “weight of evidence” and “best available science.” Others encouraged EPA to keep the rules focused on a framework for general process, to retain Agency discretion where appropriate, and to reserve specific scientific considerations for Agency guidance.
EPA considered all of these comments in the development of this proposed rule, and welcomes additional feedback from stakeholders on the Agency's proposed process for chemical substance prioritization as presented in this document.
This proposed rule incorporates all of the elements required by statute, but also supplements those requirements with additional criteria the Agency expects to consider, some clarifications for greater transparency, and additional procedural steps to ensure effective implementation. Specific components of the approach are discussed in this unit. EPA requests comments on all aspects of this proposed rulemaking.
The prioritization process under TSCA is the principal gateway to risk evaluation. EPA is ultimately making a judgment as to whether or not a particular chemical substance warrants further assessment. As a general matter, the overall objective of the process should be to guide the Agency towards identifying the High-Priority Substances that have the greatest hazard and exposure potential first. EPA may also consider the relative hazard and exposure of a potential candidate's likely substitute(s) in order to avoid moving the market to a chemical substance of equal or greater risks. However, the prioritization process is not intended to be an exact scoring or ranking exercise and EPA is not proposing such a system in this rule. The precise order in which EPA identifies High-Priority Substances (all of which must meet the same statutory standard) should not be allowed to slow the Agency's progress towards fully evaluating the risks from those chemical substances. Further, the level of analysis necessary to support an exact ranking system is not appropriate at the prioritization stage, where the sole outcome is a decision on whether EPA will further evaluate the chemical substance. EPA intends to conserve its resources and the Agency's deeper analytic efforts for the actual risk evaluation. This policy objective is stated directly in the proposed rule.
Low-Priority Substance designations serve some of the same policy objectives. Although the statute does not require EPA to designate more than twenty Low-Priority Substances, doing so ensures that chemical substances with clearly low hazard and exposure potential are taken out of consideration for further assessment, thereby conserving resources for the chemical substances with the greatest potential risks. There is also value in identifying Low-Priority Substances as part of this process, as it gives the public notice of chemical substances for which potential risks are likely low or nonexistent, and industry some insight into which chemical substances are likely not to be regulated under TSCA.
EPA will designate the priority of a “chemical substance,” as a whole, under this established process, and will not limit its designation to a specific use or subset of uses of a chemical substance. EPA is proposing this in response to clear statutory directives: The relevant provisions of TSCA section 6 repeatedly refer to both the designation and evaluation of “chemical substances” under the “conditions of use.” “Conditions of use” are broadly defined as “the circumstances, as determined by the Administrator, under which a chemical substance is intended, known, or reasonably foreseen to be manufactured, processed, distributed in commerce, used, or disposed of.” 15 U.S.C. 2602.
Although some commenters at the public meeting suggested that the prioritization process should allow EPA to designate a specific use of a chemical substance as a High-Priority Substance or a Low-Priority Substance, EPA does not interpret the statute to support such an interpretation. To the contrary, the addition of the phrase “conditions of use” (emphasis added) was intended to move the Agency away from its past practice of assessing only narrow uses of a chemical substance, towards a comprehensive approach to chemical substance management. While EPA clearly retains some discretion in determining those conditions of use, as a matter of law, EPA considers that it would be an abuse of that discretion to simply disregard known, intended, or reasonably foreseen uses in its analyses.
As discussed in Unit II., TSCA section 6(b)(1)(C) requires that the prioritization process last between nine and twelve months. EPA is proposing in this rule that initiation of the prioritization begins upon publication of a notice in the
This timeframe serves dual purposes. The minimum 9-month timeframe ensures that the general public; potentially-affected industries; state, tribal and local governments; environmental and health non-governmental organizations; and others have ample notice of upcoming federal action on a given chemical substance, and opportunity to engage with EPA early in the process. The 12-month maximum timeframe, coupled with the default-to-high provision discussed later, keeps the existing chemical substances review pipeline in a forward motion, and prevents EPA from getting mired in analysis before ever reaching the risk evaluation step.
TSCA section 26 provides EPA with authority to take action on categories of chemical substances. 15 U.S.C. 2625(c). “Category of Chemical Substances” is defined at 15 U.S.C. 2625(c)(2)(A). Although the proposed rule most often references “chemical substances,” EPA is also proposing to include a clear statement in the regulation that nothing in the proposed rule shall be construed as a limitation on EPA's authority to take action with respect to categories of chemical substances, and that, where appropriate, EPA can prioritize and evaluate categories of chemical substances.
Generally, all chemical substances listed on the TSCA Inventory are subject to prioritization. TSCA contemplates that, over time, all chemical substances on the TSCA Inventory will be prioritized into either High- or Low-Priority Substances, and that all High-Priority Substances will be evaluated. EPA notes that chemical substances newly added to the TSCA Inventory following EPA's completion of pre-manufacture review under section 5 of TSCA (15 U.S.C. 2604) are also candidates for prioritization, although EPA expects that such chemical substances are not likely to be High-Priority candidates in light of the risk-related determination that the Agency must make pursuant to TSCA section 5(a)(3).
TSCA further requires EPA to go through a separate process of determining which chemical substances on the TSCA Inventory are still actively being manufactured, and EPA has initiated a separate rulemaking for that purpose (RIN 2070-AK24). This distinction will inform EPA's exposure judgments during the prioritization process. However, there is nothing in TSCA that prohibits EPA from initiating the prioritization process on an “inactive” chemical substance and ultimately designating that chemical substance as either a High-Priority Substances (
As discussed earlier, TSCA requires that EPA establish a process, including criteria for designating a chemical substance as either a High-Priority Substances or Low-Priority Substance. 15 U.S.C. 2605(b)(1). Aside from the statutory preferences for chemical substances on the 2014 Update to the TSCA Work Plan (Ref. 1), the statute leaves EPA with broad discretion to choose which chemical substance to put into that process. Accordingly, this proposed rule includes a discussion of the criteria EPA expects to use to cull through the chemical substances on the TSCA Inventory. These include criteria that will be used to identify potential candidates for High-Priority Substances or Low-Priority Substances, and that describe how the extent of available information on potential candidates will affect whether they are selected for prioritization.
For example, in identifying potential candidates for High-Priority Substance designations, EPA is proposing to seek to identify chemical substances where available information suggests that the chemical substance may present a hazard and that exposure is present under “one or more conditions of use,” but where an “unreasonable risk” determination cannot be made without a more extensive or complete assessment in a risk evaluation. EPA interprets the statutory definition of a High-Priority Substance (“. . . may present an unreasonable risk [. . .] because of a potential hazard and a potential route of exposure . . .”) to set a fairly low bar, and EPA expects that a large number of chemical substances will meet this definition. Although EPA will prioritize a “chemical substance” as a whole, EPA may base its identification of a potential candidate as a High-Priority Substance, and ultimately the proposed designation, on a single condition of use, provided the hazard and exposure associated with that single use support such a designation. This proposal is based on the statutory definition of a High-Priority Substance, which is clear that the standard for the chemical as a whole can be met based on a single condition of use (“. . . because of
Conversely, in identifying potential candidates for Low-Priority Substance designation, EPA is proposing that it will seek to identify chemical substances where the information indicates that hazard and exposure potential for “all conditions of use” are so low that EPA can confidently set that chemical substance aside without doing further evaluation. By comparison, then, TSCA's definition of Low-Priority Substance (“. . . based on sufficient information, such
EPA is also proposing to include the following list of additional exposure and hazard considerations that can be used to narrow the field of potential candidates: (1) Persistent, bioaccumulative, and toxic; (2) Used in children's products; (3) Used in consumer products; (4) Detected in human and/or ecological biomonitoring programs; (5) Potentially of concern for children's health; (6) High acute and chronic toxicity; (7) Probable or known carcinogen; (8) Neurotoxicity; or (9) Other emerging exposure and hazard concerns to human health or the environment, as determined by the Agency. These criteria are drawn from EPA's 2012 TSCA Work Plan methodology (Ref. 4), which, as discussed earlier, was the process EPA had been using to prioritize chemical substances for assessment under TSCA. EPA will evaluate one or more of these nine considerations, and chemical substances that meet one or more of these criteria may be identified as potential candidates for High-Priority Substance designations. For example, if a chemical substance is highly toxic and used in consumer products, EPA may wish to consider that chemical substance as a potential High-Priority Substance candidate. EPA may also choose to identify potential candidates based on other criteria that suggest the chemical substance may otherwise present a human health or environmental concern, as contemplated in the “catch-all” provision (9). The fact that a chemical substance meets one of these criteria is not determinative of an outcome, including whether or not EPA will select the chemical substance to go into the prioritization process and/or the priority designation that the chemical substance will ultimately receive. Conversely, chemical substances that meet none of these criteria may be good potential candidates for Low-Priority Substance designation. The considerations are intended to serve as a general guide for the Agency, based on EPA's current understanding of important considerations regarding
Another key consideration in the pre-prioritization phase is the existence and availability of risk-related information on a candidate or potential candidate chemical substance. Because EPA must complete its prioritization process within 12 months once prioritization has been initiated for a chemical substance, immediately initiate a risk evaluation for High-Priority Substance, and complete the risk evaluation within three years of initiation, EPA cannot assume that it will be able to require the generation of critical information during these time frames. Furthermore, the statute does not grant EPA the discretion to significantly delay either of these processes, pending development of information. Consequently, prior to initiating the prioritization process for a chemical substance, EPA will generally review the available hazard and exposure-related information, and evaluate whether that information would be sufficient to allow EPA to complete both prioritization and risk evaluation processes. As part of such an evaluation, EPA expects to consider the quality, objectivity, utility, and integrity of the available information. To the extent the information is not currently available or is insufficient, EPA will determine whether or not information can be developed and collected, reviewed and incorporated into analyses and decisions in a timely manner. The proposed rule makes it clear that sufficiency of available information is likely to be a crucial factor in the selection of the chemical substances that EPA chooses to put into the prioritization process.
As noted, if information gaps are identified
The proposed rule makes clear that EPA generally expects to use this new authority, as appropriate and necessary, to gather the requisite information prior to initiating prioritization. This could include, as appropriate, TSCA information collection, testing, and subpoena authorities, including those under TSCA sections 4, 8, and 11(c), to develop needed information.
Given the importance of ensuring that sufficient information is available to conduct the prioritization and risk evaluation processes, EPA is proposing to include this consideration during the earliest stage in the process: During the identification of potential candidates. However, this criterion remains relevant even after EPA has selected a candidate and screened that chemical substance against the statutory criteria in TSCA section 6(b)(1)(A). Thus, if at any time prior to the publication of a notice in the
As noted in Unit II., TSCA requires that EPA give preference to chemical substances listed in the 2014 update of the TSCA Work Plan for Chemical Assessments that (1) have a Persistence and Bioaccumulation Score of 3; and (2) are known human carcinogens and have high acute and chronic toxicity. TSCA section 6(b)(2)(B) further requires that 50 percent of all ongoing risk evaluations be drawn from the 2014 Update to the TSCA Work Plan for Chemical Assessments, meaning that EPA will need to draw at least 50 percent of High-Priority Substance candidates from the same list. By operation of the statute, TSCA requires that all TSCA Work Plan chemical substances eventually be prioritized. However, it is premature to presume that those chemical substances will necessarily be prioritized as High-Priority Substances, or that EPA would find unreasonable risk.
Aside from these statutory preferences, however, TSCA does not limit how EPA must ultimately select a candidate chemical substance to put into the prioritization process. EPA is proposing that it will select a candidate—for either High-Priority Substances or Low-Priority Substance—based on the policy objectives described in Unit III.A. and the pre-prioritization considerations described in Unit III. F. and G. The development of the proposed rule, including these policy objectives, considerations and criteria, was informed by EPA's experience implementing the 2012 TSCA Work Plan methodology, which has been the Agency's primary tool for identifying candidate chemical substances for further assessment under TSCA. In addition, EPA fully recognizes the important role that stakeholders can play in helping the Agency to identify candidates for prioritization or to better understand the unique uses or characteristics of a particular chemical. EPA continues to welcome this type of engagement and dialogue early in the process, including during the pre-prioritization phase. While the proposed rule provides multiple opportunities for public feedback
Once a single candidate chemical substance (or category of chemical substances)
The screening review is not a risk evaluation, but rather a review of available information on the chemical substance that relates to the screening criteria. EPA expects to evaluate all relevant sources of information while conducting the screening review, including, as appropriate, the hazard and exposure sources listed in Appendices A and B of the 2012 TSCA Work Plan methodology (Ref. 4). Ultimately, the screening review and other considerations during the pre-prioritization phase are meant to inform EPA's decisions on (1) whether to initiate the prioritization process on a particular chemical substance, and (2) once initiated, the proposed designation of that chemical substance as either a High-Priority Substances or Low-Priority Substance.
The prioritization process officially begins, for purposes of triggering the nine to twelve month statutory timeframe, when EPA publishes a notice in the
Based on the results of the screening review, relevant information received from the public in the initial comment period, and other information as appropriate, EPA will propose to designate the chemical substance as either a High-Priority Substance or Low-Priority Substance, as those terms are defined in TSCA. In making this proposed designation, as directed by the statute, EPA will not consider costs or other non-risk factors.
This proposed rule provides that EPA will publish the proposed designation in the
In the event of insufficient information at the proposed designation step, EPA is proposing to designate a chemical substance as a High-Priority Substance. EPA expects this situation to occur infrequently based on its application of the criteria and considerations during the pre-prioritization phase. However, if for some reason the information available to EPA is insufficient to support a proposed designation of the chemical substance as a Low-Priority Substance, including after any extension of the initial public comment period, consistent with the statute, the proposed rule requires EPA to propose to designate the chemical substance as a High-Priority Substance. The statute requires that the prioritization process lead to one of two outcomes by the end of the 12-month deadline: A High-Priority Substance designation or a Low-Priority Substance designation. 15 U.S.C. 2605(b)(1)(B). There is no third option to allow EPA to either require the development of additional information or otherwise toll this deadline. Further, the statute specifically requires that a Low-Priority Substance designation be based on “information sufficient to establish” that a chemical substance meets the definition. 15 U.S.C. 2605(b)(1)(B)(ii). There is no comparable statutory requirement for High-Priority Substance designations. 15 U.S.C. 2605(b)(1)(B)(i). It is also relevant that the effect of designating a chemical as High-Priority Substance is that EPA further evaluates the chemical substance; by contrast, a Low-Priority Substance designation is a final Agency determination that no further evaluation is warranted—a determination that constitutes final agency action, subject to judicial review. 15 U.S.C. 2618(a)(1)(C)(i).
The logical implication of this statutory structure is that scientific uncertainty in this process (including as a result of insufficient information) is to weigh in favor of a High-Priority Substance designation, as it is merely an interim step that ensures that the chemical will be further evaluated. EPA's proposal would also ensure that this process would not create any incentives for parties to withhold readily available information, or inadvertently discourage the voluntary generation of data, as could occur were EPA to establish, for example, a default designation to Low-Priority. As a practical matter, however, EPA expects this situation to occur infrequently, based on its proposed criteria and considerations that will generally ensure that sufficient information is available to conduct a risk evaluation before initiating prioritization. Priority designations, whether they were based on sufficient information or a lack of sufficient information, are neither an
For proposed designations as Low-Priority Substances, EPA is proposing to require that all comments that could be raised on the issues in the proposed designation must be presented during the comment period. Any issues not raised will be considered to have been waived, and may not form the basis for an objection or challenge in any subsequent administrative or judicial proceeding. This is a well-established principle of administrative law and practice,
After considering any additional information collected during the proposed designation step, as appropriate, the last step in the prioritization process is for EPA to finalize its designation of a chemical substance as either a High-Priority Substance or a Low-Priority Substance. The proposed rule specifies that EPA will publish the priority designation in the
TSCA requires EPA to finalize a designation for at least one new High-Priority Substance upon completion of a risk evaluation for another chemical substance, other than a risk evaluation that was requested by a manufacturer. Because the timing for the completion of risk evaluation and/or the prioritization process will be difficult to predict, EPA intends to satisfy this 1-off-1-on replacement obligation as follows: In the notice published in the
Final designation of a chemical substance as a High-Priority Substance requires EPA to immediately begin a risk evaluation on that chemical substance. It is important to note that High-Priority Substance designation does not mean that the Agency has determined that the chemical substance presents a risk to human health or the environment—only that the Agency intends to consider the chemical substance for further risk review and evaluation. A High-Priority Substance designation is not a final agency action and is not subject to judicial review or review under the Congressional Review Act (CRA), 5 U.S.C. 801
Final designation of a chemical substance as a Low-Priority Substance means that a risk evaluation of the chemical substance is not warranted at the time, but does not preclude EPA from later revising the designation, if warranted. Notably, a Low-Priority Substance designation is explicitly subject to judicial review. 15 U.S.C. 2618(a)(1)(C).
TSCA provides that EPA may revise a final designation of a chemical substance from a Low-Priority Substance to a High-Priority Substance at any time based on information available to the Agency. The proposed rule outlines the process the Agency will take to revise such a designation. Specifically, EPA would (1) re-screen the chemical substance incorporating the relevant information, (2) re-initiate the prioritization process and take public comment, (3) re-propose a priority designation and take public comment, and (4) re-finalize the priority designation. EPA will not revise a final designation of a chemical substance from High-Priority Substance to Low-Priority Substance, but rather see the risk evaluation process through to its conclusion.
The following is a listing of the documents that are specifically referenced in this document. The docket includes these documents and other information considered by EPA, including documents that are referenced within the documents that are included in the docket, even if the referenced document is not physically located in the docket. For assistance in locating these other documents, please consult the technical person listed under
Additional information about these statutes and Executive Orders can be
This action is a significant regulatory action that was submitted to the Office of Management and Budget (OMB) for review under Executive Orders 12866 (58 FR 51735, October 4, 1993) and 13563 (76 FR 3821, January 21, 2011). Any changes made in response to OMB recommendations have been documented in the docket.
This action does not contain any information collection activities that require approval under the PRA, 44 U.S.C. 3501
I certify under section 605(b) of the RFA, 5 U.S.C. 601
This action does not contain any unfunded mandate as described in UMRA, 2 U.S.C. 1531-1538, and does not significantly or uniquely affect small governments. The action imposes no enforceable duty on any state, local or tribal governments or the private sector.
This action does not have federalism implications as specified in Executive Order 13132 (64 FR 43255, August 10, 1999). It will not have substantial direct effects on the states, on the relationship between the national government and the states, or on the distribution of power and responsibilities among the various levels of government.
This action does not have tribal implications as specified in Executive Order 13175 (65 FR 67249, November 9, 2000). It will not have substantial direct effects on one or more Indian tribes, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes. Thus, Executive Order 13175 does not apply to this action.
EPA interprets Executive Order 13045 (62 FR 19885, April 23, 1997) as applying only to those regulatory actions that concern environmental health or safety risks that the EPA has reason to believe may disproportionately affect children, per the definition of “covered regulatory action” in section 2-202 of the Executive Order. This action is not subject to Executive Order 13045 because it does not concern an environmental health risk or safety risk.
This action is not a “significant energy action” as defined in Executive Order 13211 (66 FR 28355, May 22, 2001), because it is not likely to have a significant adverse effect on the supply, distribution or use of energy. This rulemaking addresses internal EPA operations and procedures and does not impose any requirements on the public.
This rulemaking does not involve any technical standards, and is therefore not subject to considerations under NTTAA section 12(d), 15 U.S.C. 272 note.
This action does not establish an environmental health or safety standard, and is therefore not is not subject to environmental justice considerations under Executive Order 12898 (59 FR 7629, February 16, 1994). This rulemaking addresses internal EPA operations and procedures and does not have any impact on human health or the environment.
Environmental protection, Chemicals, Chemical substances, Hazardous substances, Health and safety, Prioritization, Screening, Toxic substances.
Therefore, 40 CFR chapter I, subchapter R, is proposed to be amended as follows:
15 U.S.C. 2605 and 2619.
15 U.S.C. 2605 and 2619.
(a)
(b)
(c)
(d)
(e)
(f)
For purposes of this subpart, the following definitions apply:
(a)
(b)
(c)
In identifying potential candidates for prioritization, EPA will generally evaluate whether or not the chemical substance meets one or more of the following exposure or hazard considerations:
(1) Persistent, bioaccumulative, and toxic;
(2) Used in children's products;
(3) Used in consumer products;
(4) Detected in human and/or ecological biomonitoring programs;
(5) Potentially of concern for children's health;
(6) High acute and chronic toxicity;
(7) Probable or known carcinogen;
(8) Neurotoxicity; or
(9) Other emerging exposure and hazard concerns to human health or the environment, as determined by the Agency.
(d)
(1) The availability of information and resources necessary and sufficient to support a priority designation pursuant to 40 CFR 702.11, a risk evaluation pursuant to 40 CFR 702, subpart B, or other such action as determined by the Administrator; and
(2) The ability of EPA to timely develop or require development of information necessary and sufficient to support a priority designation pursuant to 40 CFR 702.11; a risk evaluation pursuant to 40 CFR 702, subpart B; or other such action as determined by the Agency.
(e)
(a)
(1) Give preference to:
(A) Chemical substances that are listed in the 2014 update of the TSCA Work Plan for Chemical Assessments as having a persistence and bioaccumulation score of 3, and
(B) Chemical substances that are listed in the 2014 update of the TSCA Work Plan for Chemical Assessments that are known human carcinogens and have high acute and chronic toxicity; and
(2) Identify a sufficient number of candidates from the 2014 update of the TSCA Work Plan for Chemical Assessments to ensure that, at any given time, at least 50 percent of risk evaluations being conducted by EPA are drawn from that list until all substances on the list have been designated as either a High-Priority Substance or Low-Priority Substance pursuant to 40 CFR 702.13.
(1) The chemical substance's hazard and exposure potential;
(2) The chemical substance's persistence and bioaccumulation;
(3) Potentially exposed or susceptible subpopulations;
(4) Storage of the chemical substance near significant sources of drinking water;
(5) The chemical substance's conditions of use or significant changes in conditions of use;
(6) The chemical substance's production volume or significant changes in production volume; and
(7) Any other risk-based criteria relevant to the designation of the chemical substance's priority, in EPA's discretion.
(d)
(e) The purpose of the preferences and criteria in paragraph (a) of this section and the screening review in paragraph (c) of this section are to inform EPA's decision whether or not to initiate the prioritization process pursuant to 40 CFR 702.9, and the proposed designation of the chemical substance as either a High-Priority Substance or a Low-Priority Substance pursuant to 40 CFR 702.11.
(f) If, after the screening review in paragraph (c) of this section, EPA believes it will not have sufficient information to support a proposed priority designation pursuant to 40 CFR 702.11, a risk evaluation pursuant to 40 CFR 702, subpart B, or other such action as determined by the Agency, EPA is likely to use its authorities under the Act, and other information gathering authorities, to generate the needed information before initiating prioritization pursuant to 40 CFR 702.9.
(a) EPA generally expects to initiate the prioritization process for a chemical substance only when it believes that all or most of the information necessary to prioritize and perform a risk evaluation on the substance already exists.
(b) EPA will initiate prioritization by publishing a notice in the
(c) The prioritization timeframe in 40 CFR 702.1(d) begins upon EPA's publication of the notice described in paragraph (b) of this section.
(d) The results of the screening review published pursuant to paragraph (b) of this section will identify, in a form and manner that EPA deems appropriate, the information analysis and basis used in conducting the screening process. Subject to 15 U.S.C. 2613, copies of the information will also be placed in a public docket established for each chemical substance.
(e) Publication of a notice in the
(f) EPA may, in its discretion, extend the public comment period in paragraph (b) of this section for up to three months in order to receive or evaluate information submitted under 15 U.S.C. 2603(a)(2)(B). The length of the extension will be based upon EPA's assessment of the time necessary for EPA to receive and/or evaluate information submitted under 15 U.S.C. 2603(a)(2)(B).
(a) Based on the results of the screening review in 40 CFR 702.7(c), relevant information received from the public as described in 40 CFR 702.9(e), and other information as appropriate and in EPA's discretion, EPA will propose to designate the chemical substance as either a High-Priority Substance or Low-Priority Substance.
(b) EPA will not consider costs or other non-risk factors in making a proposed priority designation.
(c) If information available to EPA remains insufficient to enable the proposed designation of the chemical substance as a Low-Priority Substance, including after any extension of the initial public comment period pursuant to 40 CFR 702.9(f), EPA will propose to designate the chemical substance as a High-Priority Substance.
(d) EPA may propose to designate a chemical substance as a High-Priority Substance based on the proposed conclusion that the chemical substance satisfies the definition of High-Priority Substance in 40 CFR 702.3 under any one or more uses that the Agency determines constitute conditions of use as defined in 15 U.S.C. 2602. EPA will propose to designate a chemical substance as a Low-Priority Substance based only on the proposed conclusion that the chemical substance satisfies the definition of Low-Priority Substance in 40 CFR 702.3 under all uses that the Agency determines constitute conditions of use as defined in 15 U.S.C. 2602.
(e) EPA will publish the proposed designation in the
(f) For chemical substances that EPA proposes to designate as Low-Priority Substances, EPA will specify in the notice published pursuant to paragraph (e) of this section that all comments that could be raised on the issues in the proposed designation must be presented during this comment period. Any issues not raised at this time will be considered to have been waived, and may not form the basis for an objection or challenge in any subsequent administrative or judicial proceeding.
(a) After considering any additional information collected from the proposed designation process in 40 CFR 702.11, as appropriate, EPA will finalize its designation of a chemical substance as either a High-Priority Substance or a Low-Priority Substance.
(b) EPA will not consider costs or other non-risk factors in making a final priority designation.
(c) EPA will publish each final priority designation in the
(d) EPA will finalize a designation for at least one High-Priority Substance for each risk evaluation it completes, other than a risk evaluation that was requested by a manufacturer pursuant to 40 CFR 702, subpart B. The obligation in 15 U.S.C. 2605(b)(3)(C) will be satisfied by the designation of at least one High-Priority Substance where such designation specifies the risk evaluation that the designation corresponds to, and where the designation occurs within a reasonable time before or after the completion of the risk evaluation.
(e) If information available to EPA remains insufficient to enable the final designation of the chemical substance as a Low-Priority Substance, EPA will finalize the designation of the chemical substance as a High-Priority Substance.
EPA may revise a final designation of chemical substance from Low-Priority to High-Priority Substance at any time based on information available to the Agency. To revise such a designation, EPA will re-screen the chemical substance pursuant to 40 CFR 702.7(c), re-initiate the prioritization process on that chemical substance in accordance with 40 CFR 702.9, propose a priority designation pursuant to 40 CFR 702.11, and finalize the priority designation pursuant to 40 CFR 702.13. EPA will not revise a final designation of a chemical substance from a High-Priority Substance designation to Low-Priority.
Designation of a chemical substance as a Low-Priority Substance under 40 CFR 702.3 means that a risk evaluation of the chemical substance is not warranted at the time, but does not preclude EPA from later revising the designation pursuant to 40 CFR 702.15, if warranted.
Final designation of a chemical substance as a High-Priority Substance under 40 CFR 702.13 initiates a risk evaluation pursuant to 40 CFR 702, subpart B. Designation as a High-Priority Substance is not a final agency action and is not subject to judicial review.
Federal Communications Commission.
Petition for reconsideration.
A Petition for Reconsideration (Petition) has been filed in the Commission's rulemaking proceeding, Sarah E. Ducich and Mark W. Brennan on behalf of Navient Corp., Joseph Popevis and Rich Benenson on behalf of Nelnet Servicing LLC, Rebecca Emily Rapp on behalf of Great Lakes Higher Education Corporation, Jason L. Swartley on behalf of Pennsylvania Higher Education Assistance Agency, and Winfield P. Crigler on behalf of Student Loan Servicing Alliance.
Oppositions to the Petition must be filed on or before February 1, 2017. Replies to an opposition must be filed on or before February 13, 2017.
Federal Communications Commission, 445 12th Street SW., Washington, DC 20554.
Kristi Thornton, Consumer Policy Division, Consumer and Governmental Affairs Bureau, at (202) 418-2467 or email:
This is a summary of the Commission's document, Report No. 3066, released January 6, 2017. The full text of the Petition is available for viewing and copying at the FCC Reference Information Center, 445 12th Street SW., Room CY-A257, Washington, DC 20554. It also may be accessed online via the Commission's Electronic Comment Filing System at:
Rural Utilities Service, USDA.
Notice of Solicitation of Applications (NOSA).
The Rural Utilities Service (RUS), an agency of the United States Department of Agriculture (USDA), announces the application window, requirements and funding for loans that may become available for Fiscal Year (FY) 2017 under the Guarantees for Bonds and Notes Issued for Electrification or Telephone Purposes Program (the 313A Program) authorized under the Rural Electrification Act of 1936, as amended, and related terms. Under the 313A Program, the Federal Financing Bank (FFB) will make loans to the selected applicant(s) and RUS will guarantee the applicant(s)'s repayment of the loans to FFB. Selected applicants may use the proceeds of loan funds made available under the 313A Program to make loans to borrowers for electrification or telecommunications purposes, or to refinance bonds or notes previously issued by applicants for such purposes. The proceeds of the guaranteed bonds and notes are not to be used by applicants to directly or indirectly fund projects for the generation of electricity.
This notice is based on loan levels contemplated by the FY 17 Continuing Resolution and on information available to the agency at the time of this notice. The final amount of funding made available under this notice could be affected by subsequent Congressional action or subsidy rate calculations. Last year, the RUS obligated $750 million in loan funds for this program. It is necessary to publish this notice at this time to ensure that applicants have sufficient time to prepare applications and to ensure that the agency has sufficient time and resources to evaluate applications.
Completed applications must be received by RUS no later than 5:00 p.m. Eastern Daylight Time (EDT) on April 28, 2017.
Applicants are required to submit one original and two copies of their loan applications to the U.S. Department of Agriculture, Rural Utilities Service, Electric Program, ATTN: Amy McWilliams, Management Analyst, 1400 Independence Avenue SW., STOP 1568, Room 0226-S, Washington, DC 20250-1568.
For further information contact Amy McWilliams, Management Analyst, 1400 Independence Avenue SW., STOP 1568, Room 0226-S, Washington, DC 20250-1568. Telephone: (202) 205-8663; or email:
The purpose of the 313A Program is to make guaranteed loans to selected applicants (each referred to as “Guaranteed Lender” in this NOSA and in the Program Regulations) that are to be used (i) to make loans for electrification or telecommunications purposes eligible for assistance under the RE Act (defined herein) and regulations for the 313A Program located at 7 CFR part 1720 (also referred to as the “Program Regulations” in this NOSA), or (ii) to refinance bonds or notes previously issued by the Guaranteed Lender for such purposes. The proceeds of the guaranteed bonds and notes are not to be used by the Guaranteed Lender to directly or indirectly fund projects for the generation of electricity.
The 313A Program is authorized by Section 313A of the Rural Electrification Act of 1936, as amended (7 U.S.C. 940c-1) (the RE Act) and is implemented by regulations located at 7 CFR part 1720. The Administrator of RUS (the Administrator) has been delegated responsibility for administering the 313A Program.
The definitions applicable to this NOSA are published at 7 CFR 1720.3.
RUS will review and evaluate applications received in response to this NOSA based on the regulations at 7 CFR 1720.7, and as provided in this NOSA.
1.
a. A bank or other lending institution organized as a private, not-for-profit cooperative association, or otherwise organized on a non-profit basis; and
b. Able to demonstrate to the Administrator that it possesses the appropriate expertise, experience, and qualifications to make loans for electrification or telephone purposes.
2.
a. The Guaranteed Lender must furnish the Administrator with a certified list of the principal balances of eligible loans outstanding and certify that such aggregate balance is at least equal to the sum of the proposed principal amount of guaranteed bonds to be issued, including any previously issued guaranteed bonds outstanding;
b. The guaranteed bonds to be issued by the Guaranteed Lender would receive an underlying investment grade rating from a Rating Agency, without regard to the guarantee; and
3. A lending institution's status as an eligible applicant does not assure that the Administrator will issue the guarantee sought in the amount or under the terms requested, or otherwise preclude the Administrator from declining to issue a guarantee.
Applications will only be accepted from lenders that serve rural areas defined in 7 CFR 1710.2(a) as (i) Any area of the United States, its territories and insular possessions (including any area within the Federated States of Micronesia, the Marshall Islands, and the Republic of Palau) other than a city, town, or unincorporated area that has a population of greater than 20,000 inhabitants; and (ii) Any area within a service area of a borrower for which a borrower has an outstanding loan as of June 18, 2008, made under titles I through V of the Rural Electrification Act of 1936 (7 U.S.C. 901-950bb). For initial loans to a borrower made after June 18, 2008, the “rural” character of an area is determined at the time of the initial loan to furnish or improve service in the area.
All applications must be prepared and submitted in accordance with this NOSA and 7 CFR 1720.6 (Application Process). To ensure the proper preparation of applications, applicants should carefully read this NOSA and 7 CFR part 1720 (available online at
In addition to the required application specified in 7 CFR 1720.6, all applicants must submit the following additional required documents and materials:
1.
2.
3.
4.
5.
6.
7.
1.
2.
1.
a. Applications will be subject to a substantive review, on a competitive basis, by the Administrator based upon the evaluation factors listed in 7 CFR 1720.7(b).
2.
Before a guarantee decision is made by the Administrator, the Administrator shall request that FFB review the rating agency determination required by 7 CFR 1720.5(b)(2) as to whether the bond or note to be issued would be below investment grade without regard to the guarantee.
The requirements under this section must be met by the applicant prior to the endorsement of a guarantee by the Administrator (See 7 CFR 1720.8).
Each Guaranteed Lender will be required to enter into a Guarantee Agreement with RUS that contains the provisions described in 7 CFR 1720.8 (Issuance of the Guarantee), 7 CFR 1720.9 (Guarantee Agreement), and 7 CFR 1720.12 (Reporting Requirements). The Guarantee Agreement will also obligate the Guaranteed Lender to pay, on a semi-annual basis, a guarantee fee equal to 15 basis points (0.15 percent) of the outstanding principal amount of the guaranteed loan (See 7 CFR 1720.10).
Guaranteed Lenders are required to comply with the financial reporting requirements and pledged collateral review and certification requirements set forth in 7 CFR 1720.12.
RUS will send a commitment letter to an applicant once the loan is approved. Applicants must accept and commit to all terms and conditions of the loan which are requested by RUS and FFB as follows:
1.
a. Each Guaranteed Lender selected under the 313A Program will be required to post collateral for the benefit of RUS in an amount equal to the aggregate amount of loan advances made to the Guaranteed Lender under the 313A Program.
b. The pledged collateral shall consist of outstanding notes or bonds payable to the Guaranteed Lender (the Eligible Securities) and shall be placed on deposit with a collateral agent for the benefit of RUS. To be deemed Eligible Securities that can be pledged as collateral, the notes or bonds to be pledged (i) cannot be classified as non-performing, impaired, or restructured under generally accepted accounting principles, (ii) cannot be comprised of more than 30% of bonds or notes from generation and transmission borrowers or (iii) cannot have more than 5% of notes and bonds be from any one particular borrower.
c. The Guaranteed Lender will be required to place a lien on the pledged collateral in favor of RUS (as secured party) at the time that the pledged collateral is deposited with the collateral agent. RUS will have the right, in its sole discretion, within 14 business days to reject and require the substitution of any Pledged Collateral that the Guaranteed Lender deposits as collateral with the collateral agent. Prior to receiving any advances under the 313A Program, the Guaranteed Lender will be required to enter into a pledge agreement, satisfactory to RUS, with a banking institution serving as collateral agent.
d. The Guaranteed Lender will be required to maintain pledged collateral at a level that is sufficient to ensure that, upon the occurrence of an event of default, resources will be available to cover (i) principal, interest, fees and (ii) reasonable expenses incurred by RUS as a result of a default or incurred pursuant to RUS's obligation to make related payments to FFB under the RUS Guarantee on all guarantees issued by RUS to FFB for the benefit of the Guaranteed Lender under Section 313A of the RE Act. The Guaranteed Lender will also be required to agree that the pledged collateral can be used for such purposes.
e. The Guaranteed Lender will be required to agree to not to take any action that would have the effect of reducing the value of the Pledged Collateral below the level described above.
f. Applicants must certify to the RUS, the portion of their Eligible Loan portfolio that is:
(1) Refinanced RUS debt;
(2) Debt of borrowers for whom both RUS and the applicants have outstanding loans; and
(3) Debt of borrowers for whom both RUS and the applicant have outstanding concurrent loans pursuant to Section 307 of the RE Act, and the amount of Eligible Loans.
2.
a. This obligation is subject to the provisions contained in the Consolidated Appropriations Act, 2016, Public Law 114-113, Division A, Title VII, Sections 745 and 746, as amended and/or subsequently enacted for USDA agencies and offices regarding corporate felony convictions and corporate federal tax delinquencies.
b. An authorized official within your organization must execute, date, and return the loan commitment letter and the Assurance Regarding Felony Conviction or Tax Delinquent Status for Corporate Applicants (Form AD-3031) to RUS by September 28, 2017; otherwise, the commitment will be void. This form is available at
c. Uniform Commercial Code (UCC) Filing. The Borrower must provide RUS with evidence that the Borrower has filed the UCC financing statement required pursuant to Section 2.05(i) of the Pledge Agreement. Upon filing of the appropriate UCC financing statement, the Guaranteed Lender will provide RUS with a perfection opinion by outside counsel, satisfactory to RUS, which demonstrates that RUS's security interest in the Pledged Collateral under the Pledge Agreement is perfected.
d. Additional conditions may be instituted for future obligations.
For any proceeds to be used to refinance bonds and notes previously issued by the Guaranteed Lender for the RE Act purposes that are not obligated with specific projects, RUS has determined that these financial actions will not individually or cumulatively have a significant effect on the human environment as defined by the National Environmental Policy Act of 1969 (42 U.S.C. 4321
Applications must contain all of the required elements of this NOSA and all
In accordance with Federal civil rights law and U.S. Department of Agriculture (USDA) civil rights regulations and policies, the USDA, its Agencies, offices, and employees, and institutions participating in or administering USDA programs are prohibited from discriminating based on race, color, national origin, religion, sex, gender identity (including gender expression), sexual orientation, disability, age, marital status, family/parental status, income derived from a public assistance program, political beliefs, or reprisal or retaliation for prior civil rights activity, in any program or activity conducted or funded by USDA (not all bases apply to all programs). Remedies and complaint filing deadlines vary by program or incident.
Persons with disabilities who require alternative means of communication for program information (
To file a program discrimination complaint, complete the USDA Program Discrimination Complaint Form, AD-3027. This form is available at
(1)
(2)
(3)
USDA is an equal opportunity provider, employer, and lender.
7 U.S.C. 940c-1.
Commission on Civil Rights.
Notice; revision.
The Commission on Civil Rights published a notice in the
Ivy Davis, (202) 376-7533.
In the
Notice is hereby given, pursuant to the provisions of the rules and regulations of the U.S. Commission on Civil Rights (Commission), and the Federal Advisory Committee Act (FACA), that the time of the January 18, 2017 planning meeting of the Delaware State Advisory Committee to the Commission is changed to 10:00 a.m. EST.
An application has been submitted to the Foreign-Trade Zones (FTZ) Board by the Port of South Louisiana, grantee of Foreign-Trade Zone 124, requesting authority to reorganize the zone to expand its service area under the alternative site framework (ASF) adopted by the FTZ Board (15 CFR Sec. 400.2(c)). The ASF is an option for grantees for the establishment or reorganization of zones and can permit significantly greater flexibility in the designation of new subzones or “usage-driven” FTZ sites for operators/users located within a grantee's “service area” in the context of the FTZ Board's standard 2,000-acre activation limit for a zone. The application was submitted pursuant to the Foreign-Trade Zones Act, as amended (19 U.S.C. 81a-81u), and the regulations of the FTZ Board (15 CFR part 400). It was formally docketed on January 10, 2017.
FTZ 124 was approved by the FTZ Board on December 20, 1985 (Board Order 319, 50 FR 53351, December 31, 1985), reorganized under the ASF on January 31, 2012 (Board Order 1814, 77 FR 6059, February 7, 2012), and its service area was expanded on July 16, 2013 (Board Order 1908, 78 FR 44094-44095, July 23, 2013). The zone currently has a service area that includes St. Charles, St. John the Baptist, St. James, Lafourche, St. Mary and Tangipahoa Parishes, Louisiana.
The applicant is now requesting authority to expand the service area of the zone to include Plaquemines and Assumption Parishes, Louisiana, as described in the application. If approved, the grantee would be able to serve sites throughout the expanded service area based on companies' needs for FTZ designation. The application indicates that the proposed expanded service area is adjacent to the Gramercy Customs and Border Protection Port of Entry.
In accordance with the FTZ Board's regulations, Camille Evans of the FTZ Staff is designated examiner to evaluate and analyze the facts and information presented in the application and case record and to report findings and recommendations to the FTZ Board.
Public comment is invited from interested parties. Submissions shall be
A copy of the application will be available for public inspection at the Office of the Executive Secretary, Foreign-Trade Zones Board, Room 21013, U.S. Department of Commerce, 1401 Constitution Avenue NW., Washington, DC 20230-0002, and in the “Reading Room” section of the FTZ Board's Web site, which is accessible via
IRIS USA, Inc. (IRIS) submitted a notification of proposed production activity to the FTZ Board for its facility in Surprise, Arizona, within FTZ 277. The notification conforming to the requirements of the regulations of the FTZ Board (15 CFR 400.22) was received on December 23, 2016.
IRIS has a pending production notification to produce plastic household storage/organizational containers and pet carriers/pens within Site 12 of FTZ 277 (B-68-2016, 81 FR 71045-71046, October 14, 2016). The current request would add a foreign-status component (steel wire dividers) to the scope of authority. Pursuant to 15 CFR 400.14(b), additional FTZ authority would be limited to the specific foreign-status component described in the submitted notification (as described below) and subsequently authorized by the FTZ Board.
Production under FTZ procedures could exempt IRIS from customs duty payments on the foreign-status component used in export production. On its domestic sales, IRIS would be able to choose the duty rates during customs entry procedures that apply to finished products—plastic household storage/organizational containers and pet carriers/pens (duty rates range from free to 5.3%)—authorized by the FTZ Board for the foreign-status steel wire dividers (duty rate, 3.4%). Customs duties also could possibly be deferred or reduced on foreign-status production equipment.
Public comment is invited from interested parties. Submissions shall be addressed to the FTZ Board's Executive Secretary at the address below. The closing period for their receipt is February 27, 2017.
A copy of the notification will be available for public inspection at the Office of the Executive Secretary, Foreign-Trade Zones Board, Room 21013, U.S. Department of Commerce, 1401 Constitution Avenue NW., Washington, DC 20230-0002, and in the “Reading Room” section of the FTZ Board's Web site, which is accessible via
For further information, contact Diane Finver at
The Department of Commerce will submit to the Office of Management and Budget (OMB) for clearance the following proposal for collection of information under the provisions of the Paperwork Reduction Act (44 U.S.C. Chapter 35).
This information collection request may be viewed at reginfo.gov
Written comments and recommendations for the proposed information collection should be sent within 30 days of publication of this notice to
In the Matter of: Berty Tyloo with last known addresses of: Rue du Pont Nerf 2, Morges, Switzerland and Rue du Centre, 2, 1131 Tolochenaz, Morges, Switzerland, Respondent
The Bureau of Industry and Security, U.S. Department of Commerce (“BIS”), has notified Berty Tyloo, of Morges, Switzerland (“Tyloo”), of its intention to initiate an administrative proceeding against Tyloo pursuant to Section 766.3 of the Export Administration Regulations (the “Regulations”),
On or about June 14, 2013, Tyloo made false or misleading statements to BIS in the course of an investigation. Specifically, Tyloo was interviewed by two BIS supervisory special agents on or about June 14, 2013, in relation to an investigation of unlicensed exports and reexports to Syria of items subject to the Regulations and manufactured by Agilent Technologies, Inc. (“Agilent”), a U.S. company. As early as 2001, Tyloo was the area sales manager or distribution channel manager for the Middle East and Africa for Agilent products for European subsidiaries or affiliates of Agilent, including with regard to the sale and distribution of Agilent products to Syria through a Lebanese distributor or reseller, Technoline SAL (“Technoline”).
During the June 2013 interview, Tyloo stated that he had “no idea” how Agilent products had ended up in Syria and that, as far as he knew, all such products had stayed in Lebanon. Similarly, when asked if Technoline had ever shipped U.S.-origin items to Syria, Tyloo stated, “No, not to my knowledge.” At the time he made these statements, Tyloo knew they were false or misleading and that, in fact, Technoline had sold and distributed Agilent items to Syria beginning in at least 2004. Between at least November 2004 and December 2010, Technoline served as a distributor/reseller of Agilent products to several countries in the Middle East region pursuant to an International Designated Reseller Program Agreement (“reseller agreement”) entered into annually with Agilent's Swiss affiliates.
Tyloo's role as the area sales manager or distribution channel manager for Agilent products in the Middle East provided Tyloo access to information about Technoline's sale and distribution of Agilent products to Syria. Upon information and belief, his ownership stake in Technoline also provided him with access to such information. In addition, consistent with the longstanding reseller arrangement described above, on various occasions Tyloo acknowledged Technoline's Syria business involving Agilent products. For example, in a November 14, 2004 message captioned “Agilent sales in Technoline,” Tyloo informed two Technoline officials that he “kept on Syria” in a “contract” for Fiscal Year 2005 between Technoline and Agilent, noting further that even if the Agilent contract administrator removed the reference, “THIS SHOULD NOT STOP US SELLING THERE (capitalization in the original).”
As alleged herein, Tyloo made false or misleading statements to BIS in the course of an investigation, in violation of Section 764.2(g) of the Regulations. Tyloo did so even though he acknowledged during the June 2013 interview that providing false or misleading information to the BIS agents was unlawful.
A. Applying for, obtaining, or using any license, license exception, or export control document;
B. Carrying on negotiations concerning, or ordering, buying, receiving, using, selling, delivering, storing, disposing of, forwarding, transporting, financing, or otherwise servicing in any way, any transaction involving any item exported or to be exported from the United States that is subject to the Regulations, or in any other activity subject to the Regulations; or
C. Benefitting in any way from any transaction involving any item exported or to be exported from the United States
A. Export or reexport to or on behalf of the Denied Person any item subject to the Regulations;
B. Take any action that facilitates the acquisition or attempted acquisition by the Denied Person of the ownership, possession, or control of any item subject to the Regulations that has been or will be exported from the United States, including financing or other support activities related to a transaction whereby the Denied Person acquires or attempts to acquire such ownership, possession or control;
C. Take any action to acquire from or to facilitate the acquisition or attempted acquisition from the Denied Person of any item subject to the Regulations that has been exported from the United States;
D. Obtain from the Denied Person in the United States any item subject to the Regulations with knowledge or reason to know that the item will be, or is intended to be, exported from the United States; or
E. Engage in any transaction to service any item subject to the Regulations that has been or will be exported from the United States and which is owned, possessed or controlled by the Denied Person, or service any item, of whatever origin, that is owned, possessed or controlled by the Denied Person if such service involves the use of any item subject to the Regulations that has been or will be exported from the United States. For purposes of this paragraph, servicing means installation, maintenance, repair, modification or testing.
This Order, which constitutes the final agency action in this matter, is effective immediately.
Enforcement and Compliance, International Trade Administration, Department of Commerce.
On July 14, 2016, the Department of Commerce (Department) published the preliminary results of the 28th administrative and new shipper reviews of the antidumping duty order on tapered roller bearings and parts thereof, finished and unfinished (TRBs), from the People's Republic of China (PRC). The period of review (POR) is June 1, 2014, through May 31, 2015. After analyzing the comments received, we made no changes to the margin calculations in the administrative review and we are rescinding the new shipper review (NSR). The final weighted-average dumping margins for the reviewed firms are listed below in the section entitled “Final Results of the Review.”
Effective January 17, 2017.
Blaine Wiltse or Manuel Rey, Enforcement and Compliance, International Trade Administration, U.S. Department of Commerce, 1401 Constitution Avenue NW., Washington, DC 20230; telephone: (202) 482-6345 or (202) 482-5518, respectively.
These final results of administrative review cover four exporters of the subject merchandise, Changshan Peer Bearing Co. Ltd. (CPZ/SKF), Haining Nice Flourish Auto Parts Co., Ltd. (Nice Flourish), Roci International (HK) Limited (Roci), and Yantai CMC Bearing Co., Ltd. (Yantai CMC). The Department selected CPZ/SKF and Yantai CMC as mandatory respondents for individual examination; however, we subsequently found that Yantai CMC does not qualify for a separate rate. The NSR covers Shandong Bolong Bearing Co., Ltd. (Bolong).
On July 14, 2016, the Department published the
In August 2016, we received case briefs from the Timken Company (the petitioner), Bolong and Yantai CMC. In September 2016, we received rebuttal briefs from the petitioner and CPZ/SKF. In October 2016, the Department held a public hearing in the administrative review at the request of the petitioner.
In November 2016, the Department extended the deadline for the final results by 60 days to January 10, 2017.
The Department conducted this review in accordance with section 751 of the Act.
The merchandise covered by the order includes tapered roller bearings and parts thereof. The subject merchandise is currently classifiable under Harmonized Tariff Schedule of the United States (HTSUS) subheadings: 8482.20.00, 8482.91.00.50, 8482.99.15, 8482.99.45, 8483.20.40, 8483.20.80, 8483.30.80, 8483.90.20, 8483.90.30, 8483.90.80, 8708.70.6060, 8708.99.2300, 8708.99.4850, 8708.99.6890, 8708.99.8115, and 8708.99.8180. The HTSUS subheadings are provided for convenience and customs purposes
In the
With respect to Yantai CMC, however, we determined in the
In accordance with the U.S. Court of Appeals for the Federal Circuit's decision in Albemarle Corp. v. United States, we are applying to the exporters subject to this review that are determined to be eligible for a separate rate, but are not selected as individually examined respondents, the rate calculated for the mandatory respondent, CPZ/SKF, which is
All issues raised in the case and rebuttal briefs by parties to this administrative review and new shipper review are addressed in the Issues and Decision Memorandum. A list of the issues which parties raised and to which we respond in the Issues and Decision Memo is attached to this notice as an Appendix. The Issues and Decision Memorandum is a public document and is on file electronically via Enforcement and Compliance's Antidumping and Countervailing Duty Centralized Electronic Service System (ACCESS). ACCESS is available to registered users at
Based on our analysis of the comments received, we made no changes in the margin calculation for CPZ/SKF.
For the reasons explained in the Issues and Decision Memorandum, the Department continues to find that Bolong's sale is non-
The POR is June 1, 2014, through May 31, 2015.
Because Yantai CMC did not demonstrate that it is entitled to a separate rate, the Department finds Yantai CMC to be part of the PRC-wide entity. No party requested a review of the PRC-wide entity. Therefore, we did not conduct a review of the PRC-wide entity and the entity's rate is not subject to change.
Additionally, we are assigning the following weighted-average dumping margins to the firms listed below for the period June 1, 2014, through May 31, 2015:
We intend to disclose the calculations performed within five days of the date of publication of this notice to parties in this proceeding in accordance with 19 CFR 351.224(b).
Pursuant to section 751(a)(2)(C) of the Act, and 19 CFR 351.212(b)(1), the Department has determined, and Customs and Border Protection (CBP) shall assess, antidumping duties on all appropriate entries of subject merchandise, where applicable, in accordance with the final results of this review. The Department intends to issue assessment instructions to CBP 15 days after the date of publication of these final results of review.
Pursuant to the
For Yantai CMC, because the Department determined that this company did not qualify for a separate rate, we will instruct CBP to assess dumping duties on the company's entries of subject merchandise at the rate of 92.84 percent.
For Bolong, because the Department rescinded the NSR, the Department will instruct CBP to discontinue the option of posting a bond or security in lieu of a cash deposit for entries of subject merchandise from Bolong. Bolong continues to be part of the PRC-wide entity and, therefore, we also will instruct CBP to assess dumping duties on the company's entries of subject merchandise at the rate of 92.84 percent.
For entries that were not reported in the U.S. sales database submitted by an exporter individually examined during this review, the Department will
The following cash deposit requirements will be effective upon publication of the final results of this administrative review for all shipments of the subject merchandise entered, or withdrawn from warehouse, for consumption on or after the publication date, as provided for by section 751(a)(2)(C) of the Act: (1) For the exporters listed above, the cash deposit rate will be equal to the weighted-average dumping margin established in the final results of this review (except, if the rate is
These deposit requirements, when imposed, shall remain in effect until further notice.
This notice also serves as a final reminder to importers of their responsibility under 19 CFR 351.402(f) to file a certificate regarding the reimbursement of antidumping duties prior to liquidation of the relevant entries during this review period. Failure to comply with this requirement could result in the Secretary's presumption that reimbursement of antidumping duties occurred and the subsequent assessment of double antidumping duties.
This notice serves as the only reminder to parties subject to administrative protective order (APO) of their responsibility concerning the disposition of proprietary information disclosed under APO in accordance with 19 CFR 351.305(a)(3). Timely written notification of return or destruction of APO materials, or conversion to judicial protective order, is hereby requested. Failure to comply with the regulations and the terms of an APO is a sanctionable violation.
We are issuing and publishing these results of review in accordance with sections 751(a)(1) and 777(i)(1) of the Act.
Enforcement and Compliance, International Trade Administration, Department of Commerce.
The Court of International Trade (CIT or Court) sustained in full the Department of Commerce's (the Department) second remand results pertaining to the fifteenth administrative review of the antidumping duty order on certain corrosion-resistant steel flat products from the Republic of Korea covering the period of August 1, 2007, through July 31, 2008. The Department is notifying the public that the final judgment in this case is not in harmony with the final results of the administrative review, and that the Department is amending the final results with respect to the weighted-average dumping margins assigned to Union Steel Manufacturing Co., Ltd. (Union), Hyundai HYSCO (HYSCO), and Dongbu Steel Co., Ltd. (Dongbu).
Effective December 27, 2016.
Stephanie Moore, AD/CVD Operations, Office III, Enforcement and Compliance, International Trade Administration, U.S. Department of Commerce, 1401 Constitution Avenue NW., Washington, DC 20230; telephone: (202) 482-3692.
On March 15, 2010, the Department of Commerce (the Department) issued the
In the
On May 25, 2012, the CIT issued its opinion in
Pursuant to
Following consideration of comments submitted to the CIT on the First Remand Redetermination and an oral argument, the Court issued its decision in
In response to
In
Thus, in
In its decision in
Because there is now a final court decision, we are amending the
In the event that the CIT's rulings are not appealed or, if appealed, is upheld by a final and conclusive court decision, the Department will instruct U.S. Customs and Border Protection (CBP) to assess antidumping duties on
The Department notified CBP to discontinue the collection of cash deposits on entries of the subject merchandise, entered or withdrawn from warehouse, on or after February 14, 2012, due to the revocation of the order.
This notice is issued and published in accordance with sections 516A(e)(1), 751(a)(1), and 777(i)(1) of the Act.
Enforcement and Compliance, International Trade Administration, Department of Commerce.
The Department of Commerce (Department) determines that imports of certain new pneumatic off-the-road tires (OTR tires) from India are not being, or are not likely to be, sold in the United States at less than fair value (LTFV). The final estimated weighted-average dumping margins of sales at LTFV are listed below in the section entitled “Final Determination.” The finding for whether critical circumstances exist for producers and exporters subject to the all-others rate is moot because the antidumping duty margins for Alliance Tires Private Limited (ATC) and Balkrishna Industries Limited (BKT) are zero. The period of investigation is January 1, 2015, through December 31, 2015.
Effective January 17, 2017.
Lilit Astvatsatrian or Trisha Tran, AD/CVD Operations, Office IV, Enforcement and Compliance, International Trade Administration, U.S. Department of Commerce, 1401 Constitution Avenue NW., Washington, DC 20230; telephone: (202) 482-6412, or (202) 482-4852, respectively.
On August 19, 2016, the Department published the
A summary of the events that occurred since the Department published the
In accordance with the
The products covered by this investigation are OTR tires from India. For a complete description of the scope of the investigation,
All issues raised in the case and rebuttal briefs that were submitted by parties in this investigation are addressed in the Issues and Decision Memorandum. A list of these issues is attached to this notice at Appendix II.
As provided in section 782(i) of the Act, in August and September 2016, we conducted sales and cost verifications of the questionnaire responses submitted by ATC and BKT. We used standard verification procedures, including an examination of relevant accounting and production records, as well as original source documents provided by both respondents.
Based on our analysis of the comments received, pre-verification findings, and our findings at verification, we made certain changes to the dumping margin calculations for each respondent, ATC and BKT. For a discussion of these changes,
The Department has relied on partial adverse facts available under sections 776(a) and (b) of the Act.
On December 9, 2016, Petitioners
The Department determines, as provided in section 735 of the Act, that the following weighted-average dumping margins exist for the period January 1, 2015 through December 31, 2015:
Consistent with section 735(c)(1) of the Act, the Department has not determined an estimated all-others rate because it has not made an affirmative final determination of sales at LTFV.
Because the Department has not made an affirmative final determination of sales at LTFV, we are not directing U.S. Customs and Border Protection to suspend liquidation of any entries of OTR tires from India.
In the final determination of the companion countervailing duty investigation of OTR tires from India, the Department determined that the all other companies received a benefit from export subsidies.
We will disclose the calculations performed to interested parties in this proceeding within five days of the date of announcement, in accordance with 19 CFR 351.224(b).
In accordance with section 735(d) of the Act, we will notify the U.S. International Trade Commission of our final determination.
This notice will serve as a reminder to parties subject to APOs of their responsibility concerning the disposition of proprietary information disclosed under APO in accordance with 19 CFR 351.305(a)(3). Timely written notification of return or destruction of APO materials or conversion to judicial protective order is hereby requested. Failure to comply with the regulations and the terms of an APO is a sanctionable violation.
This determination and notice are issued and published in accordance with sections 735(d) and 777(i) of the Act and 19 CFR 351.210(c).
The scope of this investigation is certain new pneumatic off-the-road tires (certain off road tires). Certain off road tires are tires with an off road tire size designation. The tires included in the scope may be either tube-type
Subject tires may have the following prefix or suffix designation, which appears on the sidewall of the tire:
Prefix designations:
DH—Identifies a tire intended for agricultural and logging service which must be mounted on a DH drop center rim.
VA—Identifies a tire intended for agricultural and logging service which must be mounted on a VA multipiece rim.
IF—Identifies an agricultural tire to operate at 20 percent higher rated load than standard metric tires at the same inflation pressure.
VF—Identifies an agricultural tire to operate at 40 percent higher rated load than standard metric tires at the same inflation pressure.
Suffix designations:
ML—Mining and logging tires used in intermittent highway service.
DT—Tires primarily designed for sand and paver service.
NHS—Not for Highway Service.
TG—Tractor Grader, off-the-road tire for use on rims having bead seats with nominal +0.188” diameter (not for highway service).
K—Compactor tire for use on 5° drop center or semi-drop center rims having bead seats with nominal minus 0.032 diameter.
IND—Drive wheel tractor tire used in industrial service.
SL—Service limited to agricultural usage.
FI—Implement tire for agricultural towed highway service.
CFO—Cyclic Field Operation.
SS—Differentiates tires for off-highway vehicles such as mini and skid-steer loaders from other tires which use similar size designations such as 7.00-15TR and 7.00-15NHS, but may use different rim bead seat configurations.
All tires marked with any of the prefixes or suffixes listed above in their sidewall markings are covered by the scope regardless of their intended use.
In addition, all tires that lack any of the prefixes or suffixes listed above in their sidewall markings are included in the scope, regardless of their intended use, as long as the tire is of a size that is among the numerical size designations listed in the following sections of the Tire and Rim Association Year Book, as updated annually, unless the tire falls within one of the specific exclusions set forth below. The sections of the Tire and Rim Association Year Book listing numerical size designations of covered certain off road tires include:
The table of mining and logging tires included in the section on Truck-Bus tires;
The entire section on Off-the-Road tires;
The entire section on Agricultural tires; and
The following tables in the section on Industrial/ATV/Special Trailer tires:
• Industrial, Mining, Counterbalanced Lift Truck (Smooth Floors Only);
• Industrial and Mining (Other than Smooth Floors);
• Construction Equipment;
• Off-the-Road and Counterbalanced Lift Truck (Smooth Floors Only);
• Aerial Lift and Mobile Crane; and
• Utility Vehicle and Lawn and Garden Tractor.
Certain off road tires, whether or not mounted on wheels or rims, are included in the scope. However, if a subject tire is imported mounted on a wheel or rim, only the tire is covered by the scope. Subject merchandise includes certain off road tires produced in the subject countries whether mounted on wheels or rims in a subject country or in a third country. Certain off road tires are covered whether or not they are accompanied by other parts,
Specifically excluded from the scope are passenger vehicle and light truck tires, racing
Prefix letter designations:
AT—Identifies a tire intended for service on All-Terrain Vehicles;
P—Identifies a tire intended primarily for service on passenger cars;
LT—Identifies a tire intended primarily for service on light trucks;
T—Identifies a tire intended for one-position “temporary use” as a spare only; and
ST—Identifies a special tire for trailers in highway service.
Suffix letter designations:
TR—Identifies a tire for service on trucks, buses, and other vehicles with rims having specified rim diameter of nominal plus 0.156” or plus 0.250”;
MH—Identifies tires for Mobile Homes;
HC—Identifies a heavy duty tire designated for use on “HC” 15” tapered rims used on trucks, buses, and other vehicles. This suffix is intended to differentiate among tires for light trucks, and other vehicles or other services, which use a similar designation.
Example: 8R17.5 LT, 8R17.5 HC;
LT—Identifies light truck tires for service on trucks, buses, trailers, and multipurpose passenger vehicles used in nominal highway service;
ST—Special tires for trailers in highway service; and
M/C—Identifies tires and rims for motorcycles.
The following types of tires are also excluded from the scope: Pneumatic tires that are not new, including recycled or retreaded tires and used tires; non-pneumatic tires, including solid rubber tires; aircraft tires; and turf, lawn and garden, and golf tires. Also excluded from the scope are mining and construction tires that have a rim diameter equal to or exceeding 39 inches. Such tires may be distinguished from other tires of similar size by the number of plies that the construction and mining tires contain (minimum of 16) and the weight of such tires (minimum 1500 pounds).
The subject merchandise is currently classifiable under Harmonized Tariff Schedule of the United States (HTSUS) subheadings: 4011.20.1025, 4011.20.1035, 4011.20.5030, 4011.20.5050, 4011.61.0000, 4011.62.0000, 4011.63.0000, 4011.69.0050, 4011.92.0000, 4011.93.4000, 4011.93.8000, 4011.94.4000, 4011.94.8000, 8431.49.9038, 8431.49.9090, 8709.90.0020, and 8716.90.1020. Tires meeting the scope description may also enter under the following HTSUS subheadings: 4011.99.4550, 4011.99.8550, 8424.90.9080, 8431.20.0000, 8431.39.0010, 8431.49.1090, 8431.49.9030, 8432.90.0005, 8432.90.0015, 8432.90.0030, 8432.90.0080, 8433.90.5010, 8503.00.9560, 8708.70.0500, 8708.70.2500, 8708.70.4530, 8716.90.5035, 8716.90.5055, 8716.90.5056 and 8716.90.5059. While HTSUS subheadings are provided for convenience and customs purposes, the written description of the subject merchandise is dispositive.
Enforcement and Compliance, International Trade Administration, Department of Commerce.
The Department of Commerce (the Department) determines that countervailable subsidies are being provided to producers and exporters of ammonium sulfate from the People's Republic of China (PRC). The period of investigation is January 1, 2015 through December 31, 2015.
Effective January 17, 2017.
Robert Galantucci, AD/CVD Operations, Office IV, Enforcement and Compliance, International Trade Administration, U.S. Department of Commerce, 1401 Constitution Avenue NW., Washington, DC 20230; telephone (202) 482-2923.
On November 2, 2016, the Department published its preliminary affirmative determination that countervailable subsidies are being provided to producers and exporters of ammonium sulfate from the PRC in the
The product covered by this investigation is ammonium sulfate from the PRC. For a complete description of the scope of this investigation,
None of the mandatory respondents in this investigation provided information requested by the Department. Hence, no verification was conducted.
As discussed above, we received no comments from interested parties pertaining to the
For this final determination, as AFA, we continue to find all programs
In accordance with section 705(c)(1)(B)(i) of the Act, we calculated countervailing duty rates for the individually investigated producers/exporters of the subject merchandise, Wuzhoufeng AST and Yantai AMP.
With respect to the “all-others” rate, section 705(c)(5)(A)(ii) of the Act provides that if the countervailing duty rates established for all exporters and producers individually investigated are determined entirely in accordance with section 776 of the Act, the Department may use any reasonable method to establish an all-others rate for exporters and producers not individually investigated. In this case, the rates assigned to Wuzhoufeng AST and Yantai AMP are based entirely on facts otherwise available, with adverse inferences, under section 776 of the Act. Because there is no other information on the record with which to determine an all-others rate, in accordance with section 705(c)(5)(A)(ii) of the Act, we have established the all-others rate by applying the countervailable subsidy rates for mandatory respondents Wuzhoufeng AST and Yantai AMP. The final countervailable subsidy rates are summarized in the table below.
As a result of our
If the U.S. International Trade Commission (ITC) issues a final affirmative injury determination, we will issue a CVD order and will instruct CBP to continue to suspend liquidation under section 706(a) of the Act and to continue to require a cash deposit of estimated CVDs for such entries of merchandise in the amounts indicated above. If the ITC determines that material injury, or threat of material injury, does not exist, this proceeding will be terminated and all estimated duties deposited, or securities posted as a result of the suspension of liquidation, will be refunded or canceled.
We described the calculations used to determine CVD rates based on AFA in the Preliminary Decision Memorandum.
In accordance with section 705(d) of the Act, we will notify the ITC of our determination. In addition, we are making available to the ITC all non-privileged and non-proprietary information related to this investigation. We will allow the ITC access to all privileged and business proprietary information in our files, provided the ITC confirms it will not disclose such information, either publicly or under an administrative protective order (APO), without the written consent of the Assistant Secretary for Enforcement and Compliance.
This notice will serve as a reminder to the parties subject to APO of their responsibility concerning the disposition of proprietary information disclosed under APOs in accordance with 19 CFR 351.305. Timely written notification of the return or destruction of APO materials or conversion to judicial protective order is hereby requested. Failure to comply with the regulations and terms of an APO is a sanctionable violation.
This determination is issued and published pursuant to sections 705(d) and 777(i) of the Act.
The merchandise covered by this investigation is ammonium sulfate in all physical forms, with or without additives such as anti-caking agents. Ammonium sulfate, which may also be spelled as ammonium sulphate, has the chemical formula (NH
The scope includes ammonium sulfate that is combined with other products, including by, for example, blending (
Ammonium sulfate that has been combined with other products is included within the scope regardless of whether the
Ammonium sulfate that is otherwise subject to this investigation is not excluded when commingled (
The Chemical Abstracts Service (CAS) registry number for ammonium sulfate is 7783-20-2.
The merchandise covered by this investigation is currently classifiable under Harmonized Tariff Schedule of the United States (HTSUS) subheading 3102.21.0000. Although this HTSUS subheading and CAS registry number are provided for convenience and customs purposes, the written description of the scope of the investigation is dispositive.
Enforcement and Compliance, International Trade Administration, Department of Commerce.
On July 12, 2016, the Department of Commerce (“the Department”) published its
Effective January 17, 2017.
Sean Carey, AD/CVD Operations, Office VII, Enforcement and Compliance, International Trade Administration, U.S. Department of Commerce, 1401 Constitution Avenue NW., Washington, DC 20230; telephone: (202) 482-3964.
On July 12, 2016, the Department published its
On October 21, 2016, the Department fully extended the deadline for the final results in this administrative review until January 9, 2017.
The products covered by the order are chloro isos, which are derivatives of cyanuric acid, described as chlorinated s-triazine triones. Chlorinated isos are currently classifiable under subheadings 2933.69.6015, 2933.69.6021, 2933.69.6050, 3808.40.50, 3808.50.40 and 3808.94.5000 of the Harmonized Tariff Schedule of the United States. Although the HTSUS subheadings are provided for convenience and customs purposes, the written description of merchandise subject to the scope is dispositive. For a full description of the scope of the order,
All issues raised in the case and rebuttal briefs filed by parties in this review are addressed in the Issues and Decision Memorandum, which is hereby adopted by this notice. A list of the issues that parties raised and to which we responded in the Issues and Decision Memorandum follows as an appendix to this notice. The Issues and Decision Memorandum is a public document and is on file electronically via Enforcement and Compliance's Antidumping and Countervailing Duty Centralized Electronic Service System (“ACCESS”). ACCESS is available to registered users at
Based on a review of the record and comments received from interested parties regarding our
The weighted-average dumping margins for the administrative review are as follows:
Pursuant to section 751(a)(2)(A) of the Tariff Act of 1930, as amended (the “Act”), and 19 CFR 351.212(b), the Department has determined, and U.S. Customs and Border Protection (“CBP”) shall assess, antidumping duties on all appropriate entries of subject merchandise in accordance with the final results of this review. The Department intends to issue appropriate assessment instructions directly to CBP
Where the respondent reported reliable entered values, we calculated importer (or customer)-specific ad valorem rates by aggregating the dumping margins calculated for all U.S. sales to each importer (or customer) and dividing this amount by the total entered value of the sales to each importer (or customer).
Pursuant to the Department's assessment practice, for entries that were not reported in the U.S. sales databases submitted by companies individually examined during this review, the Department will instruct CBP to liquidate such entries at the PRC-wide entity rate. Additionally, if the Department determines that an exporter had no shipments of the subject merchandise, any suspended entries that entered under that exporter's case number (
The following cash deposit requirements will be effective upon publication of the final results of this administrative review for shipments of the subject merchandise from the PRC entered, or withdrawn from warehouse, for consumption on or after the publication date, as provided by section 751(a)(2)(C) of the Act: (1) For the exporters listed above, the cash deposit rate will be the rate established in the final results of this review (except, if the rate is zero or
We intend to disclose the calculations performed regarding these final results within five days of the date of publication of this notice to parties in this proceeding in accordance with 19 CFR 351.224(b).
This notice serves as a final reminder to importers of their responsibility under 19 CFR 351.402(f) to file a certificate regarding the reimbursement of antidumping duties prior to liquidation of the relevant entries during this POR. Failure to comply with this requirement could result in the Department's presumption that reimbursement of antidumping duties has occurred and that subsequent assessment of doubled antidumping duties.
This notice also serves as the only reminder to parties subject to administrative protective order (“APO”) of their responsibility concerning the return or destruction of proprietary information disclosed under APO in accordance with 19 CFR 351.305(a)(3), which continues to govern business proprietary information in this segment of the proceeding. Timely written notification of the return or destruction of APO materials, or conversion to judicial protective order, is hereby requested. Failure to comply with the regulations and terms of an APO is a violation which is subject to sanction.
We are issuing and publishing these final results of administrative review in accordance with sections 751(a)(1) and 777(i)(1) of the Act, and 19 CFR 351.213(h).
Enforcement and Compliance, International Trade Administration, Department of Commerce.
On July 13, 2016, the Department of Commerce (the Department) published the preliminary results of the changed circumstances review and intent to reinstate Shanghai General Bearing Co., Ltd. (SGBC/SKF) in the antidumping duty order on tapered roller bearings and parts thereof, finished and unfinished, (TRBs) from the People's Republic of China (PRC). This review covers TRBs from the PRC manufactured and exported by SGBC/SKF. The period of review is June 1, 2014, through May 31, 2015. Based on our analysis of the comments received, we made changes to the margin calculations. Therefore, the final results differ from the preliminary results. Further, we continue to determine that SGBC/SKF sold TRBs at less than normal value (NV), and, as a result, we are reinstating SGBC/SKF in the antidumping order on TRBs from the PRC. The final weighted-average dumping margin is listed below in the
Effective January 17, 2017.
Alice Maldonado, Enforcement and Compliance, International Trade Administration, U.S. Department of Commerce, 1401 Constitution Avenue NW., Washington, DC 20230; telephone (202) 482-4682.
On July 13, 2016, the Department published the preliminary results of this changed circumstances review and intent to reinstate SGBC/SKF in the antidumping duty order on TRBs from the PRC.
In August 2016, we received case briefs from the Timken Company (the petitioner) and SGBC/SKF; we also received a letter in lieu of a case brief from Stemco LP (Stemco), an interested party in the proceeding, in which Stemco supported the arguments made in the petitioner's case brief. In September 2016, we received rebuttal briefs from the petitioner and SGBC/SKF. In October 2016, the Department held a public hearing at the request of the petitioner.
The Department conducted this changed circumstances review in accordance with section 751(b)(1) of the Tariff Act of 1930, as amended (the Act) and 19 CFR 351.216(d).
The merchandise covered by the order
In requesting revocation, pursuant to 19 CFR 353.25(b) (1996) and 19 CFR 353.25(a)(2)(iii) (1996),
In this case, because other exporters in the PRC remain subject to the TRBs order, the order remains in effect, and SGBC/SKF may be reinstated in the order. The Department granted SGBC/SKF revocation based, in part, upon its agreement to immediate reinstatement in the antidumping duty order if the Department were to find that the company resumed dumping of TRBs from the PRC.
As discussed in the Issues and Decision Memo, we examined SGBC/SKF's response and preliminarily found that SGBC/SKF's dumping margin for the review period is greater than
All issues raised in the case and rebuttal briefs by parties to this changed circumstances review are addressed in the Issues and Decision Memo. A list of the issues which parties raised and to which we respond in the Issues and Decision Memo is attached to this notice as an Appendix. The Issues and Decision Memo is a public document and is on file electronically via Enforcement and Compliance's Antidumping and Countervailing Duty Centralized Electronic Service System (ACCESS). ACCESS is available to registered users at
Based on our analysis of the comments received, we made changes in the margin calculation for SGBC/SKF. These changes are discussed in the relevant sections of the Issues and Decision Memo.
The Department determines that the following weighted-average dumping margin exists for the period June 1, 2014, through May 31, 2015:
We intend to disclose the calculations performed within five days of the date of publication of this notice to parties in this proceeding in accordance with 19 CFR 351.224(b).
Because we established that TRBs from the PRC manufactured and exported by SGBC/SKF are being sold at less than NV, SGBC/SKF is hereby
This notice serves as the only reminder to parties subject to administrative protective order (APO) of their responsibility concerning the disposition of proprietary information disclosed under APO in accordance with 19 CFR 351.305(a)(3). Timely written notification of return or destruction of APO materials, or conversion to judicial protective order, is hereby requested. Failure to comply with the regulations and the terms of an APO is a sanctionable violation.
We are issuing and publishing these results of review in accordance with sections 751(b)(1) and 777(i)(1) of the Act and 19 CFR 351.216.
National Institute of Standards and Technology, Department of Commerce.
Notice of public meeting; correction.
The National Institute of Standards and Technology (NIST) originally published a document announcing an upcoming meeting of the Visiting Committee on Advanced Technology (VCAT or Committee) on January 3, 2017 (82 FR 92). The meeting time, dates, and details have been updated. The VCAT will now meet by webinar in an open session on Wednesday, February 8, 2017 from 1:30 p.m. to 4:30 p.m. Eastern Time. The VCAT is composed of fifteen members appointed by the NIST Director who are eminent in such fields as business, research, new product development, engineering, labor, education, management consulting, environment, and international relations.
The VCAT will meet by webinar on Wednesday, February 8, 2017, from 1:30 p.m. to 4:30 p.m. Eastern Time.
The meeting will be conducted by webinar. Please note instructions under the
Serena Martinez, VCAT, NIST, 100 Bureau Drive, Mail Stop 1060, Gaithersburg, Maryland 20899-1060, telephone number 301-975-2661. Mrs. Martinez's email address is
15 U.S.C. 278 and the Federal Advisory Committee Act, as amended, 5 U.S.C. App.
The purpose of this meeting is for the VCAT to review and make recommendations regarding general policy for NIST, its organization, its budget, and its programs within the framework of applicable national policies as set forth by the President and the Congress. The agenda will include an update on NIST, to include safety, and a discussion on future VCAT meeting topics and structure. NIST will also provide a brief update on the Administration and Congressional Landscape. The agenda may change to accommodate Committee business. The final agenda will be posted on the NIST Web site at
Members of the public can listen to the discussion by using a toll-free call-in number. When you register by email to Mrs. Serena Martinez,
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Notice; receipt of application.
Notice is hereby given that Katherine Mansfield, Ph.D., University of Central Florida, 4000 Central Florida Boulevard, Building 20, BIO301, Orlando, FL 32825, has applied in due form for a permit to take loggerhead (
Written, telefaxed, or email comments must be received on or before February 16, 2017.
The application and related documents are available for review by selecting “Records Open for Public Comment” from the “Features” box on the Applications and Permits for Protected Species (APPS) home page,
These documents are also available upon written request or by appointment in the Permits and Conservation Division, Office of Protected Resources, NMFS, 1315 East-West Highway, Room 13705, Silver Spring, MD 20910; phone (301) 427-8401; fax (301) 713-0376.
Written comments on this application should be submitted to the Chief, Permits and Conservation Division, at the address listed above. Comments may also be submitted by facsimile to (301) 713-0376, or by email to
Those individuals requesting a public hearing should submit a written request to the Chief, Permits and Conservation Division at the address listed above. The request should set forth the specific reasons why a hearing on this application would be appropriate.
Carrie Hubard or Amy Hapeman, (301) 427-8401.
The subject permit is requested under the authority of the Endangered Species Act of 1973, as amended (ESA; 16 U.S.C. 1531
The applicant requests a five-year permit to examine patterns and trends in the abundance, distribution, movements, foraging ecology, and population structure of sea turtles. Research would occur in three study areas: (1) Indian River Lagoon, Florida; (2) Trident Turning Basin, Cape Canaveral, Florida; and (3) Northern and Eastern Gulf of Mexico, which includes waters up to 120 miles offshore from Louisiana to Western Florida. Researchers would capture sea turtles by tangle net, dip net, or by hand; annual requested take numbers per species vary by year and project. Sea turtles would have the following procedures performed before release: Measure, flipper tag, passive integrated transponder tag, photograph/video, gastric lavage, and scute, blood, fecal, and tissue sampling. A subset of animals would receive an epoxy-attached transmitter before release.
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Notice of public meeting.
The North Pacific Fishery Management Council's (Council) Scallop Plan Team will meet February 22, 2017.
The meeting will be held on Wednesday, February 22, 2017, from 9 a.m. to 5 p.m.
The meeting will be held at Fishermen's Hall, 403 Marine Way, Kodiak, AK 99615.
Jim Armstrong, Council staff; telephone: (907) 271-2809.
The agenda includes updating the status of the Statewide Scallop Stocks and Stock Assessment and Fishery Evaluation (SAFE) compilation, update on monitoring ocean acidification and its potential effect on the scallop stocks, update on new scallop assessment programs and a review of research priorities. The Agenda is subject to change, and the latest version will be posted at
The meeting is physically accessible to people with disabilities. Requests for sign language interpretation or other auxiliary aids should be directed to Shannon Gleason at (907) 271-2809 at least 7 working days prior to the meeting date.
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Notice of receipt of an application for an exempted fishing permit; availability of a draft environmental assessment; request for comments.
NMFS announces the receipt of an application for an exempted fishing permit (EFP) from Dr. David Kerstetter of Nova Southeastern University to evaluate pelagic longline (PLL) catch and bycatch rates from within two different sub-areas in the northern portion of the East Florida Coast Pelagic Longline (PLL) Closed Area (north and south of 29°50′ N. lat.) and compare those rates to rates obtained by authorized samplers from outside the EFC PLL Closed Area and the availability of a draft Environmental Assessment (EA) analyzing the impacts of granting the application to conduct the research using commercial PLL vessels, with certain terms and conditions. The overall purpose of the research project would be to evaluate PLL catches and catch rates of target and non-target species within a portion of the EFC PLL Closed Area to evaluate the effectiveness of existing area closures at meeting current conservation and management goals under current conditions using standardized PLL gear on a specified number of commercial vessels.
Written comments on the issuance of the EFP or on the draft EA will be considered by NMFS and must be received on or before February 16, 2017.
Comments may be submitted by any of the following methods:
•
•
Craig Cockrell at (301) 427-8503 or Rick Pearson at (727) 824-5399.
NMFS published a notice of intent to issue EFPs, Scientific Research Permits, Letters of Acknowledgement, and Chartering Permits for Atlantic highly migratory species (HMS) in 2017 (81 FR 80646, November 16, 2016). Although that notice anticipated a variety of applications, it also stated that occasionally, NMFS receives applications for research activities that were not anticipated, or for research that is outside the scope of general scientific sampling and tagging of Atlantic HMS, or rarely, for research that is particularly controversial and that NMFS will provide additional opportunity for public comment, consistent with the regulations at 50 CFR 600.745 if that were to occur.
As discussed in the November 2016 notice of intent to issue EFPs and related permits, issuance of EFPs and related permits are necessary because HMS regulations (
NMFS closed the EFC area to PLL gear year-round in early 2001 (65 FR 47213, August 1, 2000). The closure was implemented to reduce bycatch and incidental catch of overfished and protected species by PLL fishermen who target HMS because there was a noticeable difference in the bycatch of some non-target species (mainly undersized swordfish) between the EFC area and open areas. At the time, Atlantic blue marlin, white marlin, sailfish, bluefin tuna, and swordfish were overfished, and bycatch reduction was a component of rebuilding efforts. In particular, the United States was implementing a 1999 swordfish rebuilding plan, and the closure helped reduce bycatch of undersized swordfish. Several other laws required that NMFS address bycatch in the HMS fisheries, including the Endangered Species Act (ESA), which required reductions in sea turtle bycatch in the PLL fishery. National Standard 9 of the MSA also requires that fishery management plans minimize bycatch and bycatch mortality to the extent practicable.
The closure has been in place for more than 15 years and, since 2001, a number of changes in stock status and fishery management measures have occurred. Specifically, North Atlantic swordfish has been rebuilt since 2009, current international assessments of white marlin and Western Atlantic sailfish indicate that overfishing is likely not occurring, the PLL fishery has been required since 2004 to use circle hooks instead of J-hooks to reduce sea turtle bycatch, and individual bluefin tuna quota (IBQ) allocations were implemented in the PLL fishery through Amendment 7 to the 2006 Consolidated HMS Fishery Management Plan in 2014 (79 FR 71509, December 2, 2014). Allowing limited access to the EFC PLL Closed Area for research purposes via an EFP would provide important data from the closed area under these changed conditions. NMFS has not obtained scientific data related to catch and bycatch rates from this area since 2010, and that data suggested that more research was needed due to the small sample size and poor spatial distribution of PLL sets in the research conducted from 2008-2010. The data resulting from the research under this EFP would be used to assess current bycatch rates during typical commercial fishing operations and to evaluate the effectiveness of the closed area in continuing to reduce bycatch of non-target species (
NMFS received an application to conduct research within two portions of the EFC PLL Closed Area and one portion of the open area (for comparative purposes) and has made a preliminary determination that it warrants further consideration and an opportunity for public comment. The application is available for review on the HMS Management Division's Web site at
NMFS invites comment on certain terms and conditions that we believe would be appropriate for inclusion on this EFP, if issued. The commercial vessels that would be participating in this EFP project are otherwise authorized to fish and, absent this EFP, would be conducting normal PLL fishing operations in open areas consistent with their past practices. NMFS conducted an analysis that compared projected catches if vessels were to continue fishing only in open areas (
• During the proposed research project, 33 percent of sets occurring in both portions of the EFC PLL Closed Area and in open areas would be observed by NMFS-trained NOVA Southeastern University students or NMFS-approved observers.
• NMFS would review 100 percent of electronic monitoring data for sets occurring in both portions of the EFC PLL Closed Area and in open areas.
• After three dusky sharks are discarded dead by a vessel participating in the EFP, that vessel would be required to reduce the soak time of the gear to no longer than 10 hours when conducting fishing operations under the EFP. If, after reducing the soak time to no longer than 10 hours, an additional three dusky sharks are discarded dead, then that vessel would no longer be authorized to fish in the EFC PLL Closed Area under this EFP, if issued, for the remainder of the 12-month project period, unless otherwise permitted by NMFS.
• All live sharks caught but not being retained must be safely sampled (
• All sharks that are dead at haul back, including prohibited species, and all sharks being retained for sale must be biologically sampled (
• Sets inside and outside of the closed areas would be equipped with hook timers, in accordance with protocols established by NMFS, to determine when animals were captured and when mortality occurs.
NMFS is also announcing the availability of a draft EA that analyzes the potential impacts to the human environment of granting this EFP application for experimental PLL fishing within northern portions of the EFC PLL Closed Area and one area outside the Closed Area, as the request is described above. Among other analyzed impacts, the draft EA projects the annual catches of all HMS species, as well as some non-HMS species interactions, from the EFC PLL Closed Area and open areas that could be expected to occur if this EFP is approved. Additionally, the draft EA describes NMFS' rationale for the preferred alternative and other alternatives under consideration for this research. The draft EA may be found on the HMS Management Division's Web site at
16 U.S.C. 971
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Notice; receipt of application.
Notice is hereby given that Whitlow Au, Ph.D., University of Hawaii, P.O. Box 1346, Kaneohe, HI 96744, has applied in due form for a permit to conduct research on marine mammals in Hawaii.
Written, telefaxed, or email comments must be received on or before February 16, 2017.
The application and related documents are available for review by selecting “Records Open for Public Comment” from the “Features” box on the Applications and Permits for Protected Species (APPS) home page,
These documents are also available upon written request or by appointment in the Permits and Conservation Division, Office of Protected Resources, NMFS, 1315 East-West Highway, Room 13705, Silver Spring, MD 20910; phone (301) 427-8401; fax (301) 713-0376.
Written comments on this application should be submitted to the Chief, Permits and Conservation Division, at the address listed above. Comments may also be submitted by facsimile to (301) 713-0376, or by email to
Those individuals requesting a public hearing should submit a written request to the Chief, Permits and Conservation Division at the address listed above. The request should set forth the specific reasons why a hearing on this application would be appropriate.
Sara Young or Carrie Hubard, (301) 427-8401.
The subject permit is requested under the authority of the Marine Mammal Protection Act of 1972, as amended (MMPA; 16 U.S.C. 1361
The applicant requests a five-year permit to investigate the population dynamics and behavior of cetaceans around Hawaii and the Pacific, to study: (1) The behavior and use of the acoustic environment by large whales, and (2) the effects of noise on behavior of cetaceans around Hawaii. The applicant proposes to use genetic sampling, suction-cup acoustic recording tags, high frequency pinger tags, biopsy sampling, darted satellite tags, acoustic recording, underwater video recording, behavioral observation, photo-identification, and acoustic playbacks. Target species would be: Blainville's beaked whale (
In compliance with the National Environmental Policy Act of 1969 (42 U.S.C. 4321
Concurrent with the publication of this notice in the
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Notice of opportunities to submit public comments.
The Pacific Fishery Management Council (Pacific Council) has announced its annual preseason management process for the 2017 ocean salmon fisheries. This notice informs the public of opportunities to provide comments on the 2017 ocean salmon management measures.
Written comments on the salmon management alternatives adopted by the Pacific Council at its March 2017 meeting, and described in Preseason Report II, received electronically or in hard copy by 5:00 p.m. Pacific Time, March 31, 2017, will be considered in the Pacific Council's final recommendation for the 2017 management measures.
Documents will be available from Mr. Herb Pollard, Chair, Pacific Fishery Management Council, 7700 NE Ambassador Place, Suite 101, Portland, OR 97220-1384, and posted on the Pacific Council Web site at
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•
•
• Comments can also be submitted via email to
Ms. Robin Ehlke, Pacific Council, telephone: 503-820-2280. For information on submitting comments via the Federal e-Rulemaking portal, contact Peggy Mundy, NMFS West Coast Region, telephone: 206-526-4323; email:
The Pacific Council has published its annual notice of availability of reports, public meetings, and hearings for the 2017 ocean salmon fisheries (81 FR 95568, December 28, 2016). The Pacific Council will adopt alternatives for 2017 ocean salmon fisheries at its meeting, March 7-14, 2017, at the Hilton in Vancouver, WA. Details of this meeting are available on the Pacific Council's Web site (
All public hearings begin at 7 p.m. at the following locations:
• March 27, 2017: Chateau Westport, Beach Room, 710 West Hancock, Westport, WA 98595, telephone 360-268-9101.
• March 27, 2017: Red Lion Hotel, South Umpqua Room, 1313 North Bayshore Drive, Coos Bay, OR 97420, telephone 541-267-4141.
• March 28, 2017: City of Fort Bragg. Town Hall, 363 North Main Street, Fort Bragg, CA 95437, telephone: (707) 961-2823.
Comments on the alternatives the Pacific Council adopts at its March 2017 meeting, and described in Preseason Report II, may be submitted in writing or electronically as described under
16 U.S.C. 1801
National Oceanic and Atmospheric Administration (NOAA), Commerce.
Notice.
The Department of Commerce, as part of its continuing effort to reduce paperwork and respondent burden, invites the general public and other Federal agencies to take this opportunity to comment on proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995.
Written comments must be submitted on or before March 20, 2017.
Direct all written comments to Jennifer Jessup, Departmental Paperwork Clearance Officer, Department of Commerce, Room 6616, 14th and Constitution Avenue NW., Washington, DC 20230 (or via the Internet at
Requests for additional information or copies of the information collection instrument and instructions should be directed to Shannah Jaburek, (978) 282-8456 or
This request is for an extension of a currently approved information collection.
The National Marine Fisheries Service (NMFS) Greater Atlantic Region manages the Atlantic sea scallop (scallop) fishery of the Exclusive Economic Zone (EEZ) off the East Coast under the Atlantic Sea Scallop Fishery Management Plan (FMP). The regulations implementing the FMP are at 50 CFR part 648. To successfully implement and administer components of the FMP, OMB Control No. 0648-0491 includes the following information collections for scallop vessel owners, operators, and fishery participants: Vessel monitoring system (VMS) trip declarations for all scallop vessels, including powerdown declarations; notification of access area trip termination for limited access scallop vessels; submission of access area compensation trip identification; submission of access area trip exchange forms; VMS purchase and installation for individuals that purchase a federally permitted scallop vessel; VMS daily catch reports; submission of ownership cap forms for individual fishing quota (IFQ) scallop vessels; submission of vessel replacement, upgrade and permit history applications for IFQ, Northern Gulf of Maine (NGOM), and Incidental Catch (IC) scallop vessels; submission of VMS pre-landing notification form by IFQ vessels and limited access vessels for access areas; enrollment into the state waters exemption program; submission of requests for IFQ transfers; payment of cost recovery bills for IFQ vessels; sector proposals for IFQ vessels and industry participants; and sector operations plans for approved sector proposals.
Data collected through these programs are incorporated into the NMFS database and are used to track and confirm vessel permit status and eligibility, scallop landings, and scallop vessel allocations. Aggregated summaries of the collected information will be used to evaluate the management program and future management proposals.
Participants will submit electronic VMS transmissions and paper applications by mail, facsimile, or email.
Comments are invited on: (a) Whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility; (b) the accuracy of the agency's estimate of the burden (including hours and cost) of the proposed collection of information; (c) ways to enhance the quality, utility, and clarity of the information to be collected; and (d) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or other forms of information technology.
Comments submitted in response to this notice will be summarized and/or included in the request for OMB approval of this information collection; they also will become a matter of public record.
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Notice; receipt of applications.
Notice is hereby given that Fred Sharpe, Ph.D., Alaska Whale Foundation, 4739 University Way NE., #1230, Seattle, WA 98105 (File No. 19703) has applied in due form for a permit to conduct research on cetaceans and Christopher Cilfone, Be Blue, 2569 Douglas Hwy. Unit 1, Juneau, AK 99801 (File No. 20993) has applied in due form to conduct commercial/educational photography on humpback whales (
Written, telefaxed, or email comments must be received on or before February 16, 2017.
The application and related documents for File No. 19703 are available for review by selecting “Records Open for Public Comment” from the “Features” box on the Applications and Permits for Protected Species (APPS) home page,
Documents for File No. 19703 and 20993 are also available upon written request or by appointment in the Permits and Conservation Division, Office of Protected Resources, NMFS, 1315 East-West Highway, Room 13705, Silver Spring, MD 20910; phone (301) 427-8401; fax (301) 713-0376.
Written comments on these applications should be submitted to the Chief, Permits and Conservation Division, at the address listed above.
Those individuals requesting a public hearing should submit a written request to the Chief, Permits and Conservation Division at the address listed above. The request should set forth the specific reasons why a hearing on the application would be appropriate.
Carrie Hubard or Shasta McClenahan, (301) 427-8401.
The subject permits are requested under the authority of the Marine Mammal Protection Act of 1972, as amended (MMPA; 16 U.S.C. 1361
Dr. Sharpe (File No. 19703) proposes to study humpback and killer (
Mr. Cilfone (File No. 20993) proposes to film humpback whales in Hawaiian waters of the Maui Nui Basin. Footage would be used to create a film about humpback whales and their conservation success that would be available on multiple platforms. Boats, unmanned aircraft systems, pole cameras, and snorkelers would all be used to get footage. Fifty humpback whales would be approached annually. In addition, pantropical spotted (
In compliance with the National Environmental Policy Act of 1969 (42 U.S.C. 4321
Concurrent with the publication of this notice in the
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Notice; public meeting.
The Tilefish Advisory Panel of the Mid-Atlantic Fishery Management Council (Council) will hold a meeting.
The meeting will be held on Thursday, February 9, 2017, beginning at 9 a.m. and conclude by 12 noon. For agenda details, see
The meeting will be held via webinar with a telephone-only connection option:
Christopher M. Moore, Ph.D., Executive Director, Mid-Atlantic Fishery Management Council, telephone: (302) 526-5255.
The purpose of the meeting is to create a fishery performance report by the Council's Tilefish Advisory Panel. The intent of this report is to facilitate a venue for structured input from the Advisory Panel members for the Golden and Blueline Tilefish specifications process, including recommendations by the Council and its Scientific and Statistical Committee (SSC).
This meeting is physically accessible to people with disabilities. Requests for sign language interpretation or other auxiliary aids should be directed to M. Jan Saunders, (302) 526-5251, at least 5 days prior to the meeting date.
National Telecommunications and Information Administration, U.S. Department of Commerce.
Notice of open meeting.
The National Telecommunications and Information Administration (NTIA) will convene a virtual meeting of a multistakeholder process concerning Internet of Things Security Upgradability and Patching on January 31, 2017.
The meeting will be held on January 31, 2017, from 2:00 p.m. to 4:30 p.m., Eastern Time.
This is a virtual meeting. NTIA will post links to online content and dial-in information on the multistakeholder process Web site at
Allan Friedman, National Telecommunications and Information Administration, U.S. Department of Commerce, 1401 Constitution Avenue NW., Room 4725, Washington, DC 20230; telephone: (202) 482-4281; email:
The matter of patching vulnerable systems is now an accepted part of cybersecurity.
To help realize the full innovative potential of IoT, users need reasonable assurance that connected devices, embedded systems, and their applications will be secure. A key part of that security is the mitigation of potential security vulnerabilities in IoT devices or applications through patching and security upgrades.
The ultimate objective of the multistakeholder process is to foster a market offering more devices and systems that support security upgrades through increased consumer awareness and understanding. Enabling a thriving market for patchable IoT requires common definitions so that manufacturers and solution providers have shared visions for security, and consumers know what they are purchasing. Currently, no such common, widely accepted definitions exist, so many manufacturers struggle to effectively communicate to consumers the security features of their devices. This is detrimental to the digital ecosystem as a whole, as it does not reward companies that invest in patching, and it prevents consumers from making informed purchasing choices.
At the October 19, 2016, meeting, stakeholders discussed the challenge of patching, and how to scope the discussion. Participants identified five distinct work streams that could help foster better security across the ecosystem, and established working groups to more fully evaluate options in each of these areas.
More information about stakeholders' work will be available at:
Department of Defense.
Amendment of Federal Advisory Committee.
The Department of Defense (DoD) is publishing this notice to announce that it is amending the charter for the Advisory Committee on Arlington National Cemetery.
Jim Freeman, Advisory Committee Management Officer for the Department of Defense, 703-692-5952.
This committee's charter is being amended in accordance with the Federal Advisory Committee Act (FACA) of 1972 (5 U.S.C., Appendix, as amended) and 41 CFR 102-3.50(d). The amended charter and contact information for the Committee's Designated Federal Officer (DFO) can be obtained at
The DoD is amending the charter for the Advisory Committee on Arlington
Department of Defense.
Termination of Federal Advisory Committee.
The Department of Defense (DoD) is publishing this notice to announce that it is terminating the Advisory Council on Dependents' Education.
Jim Freeman, Advisory Committee Management Officer for the Department of Defense, 703-692-5952.
Section 576 of the National Defense Authorization Act for Fiscal Year 2017 (Pub. L. 114-328) rescinds 22 U.S.C. 929, which is the statutory authority for the Advisory Council on Dependents' Education (“the Council”). Therefore, the Department of Defense is terminating the Council.
Notice.
The Department of Defense has submitted to OMB for clearance, the following proposal for collection of information under the provisions of the Paperwork Reduction Act.
Consideration will be given to all comments received by February 16, 2017.
Fred Licari, 571-372-0493.
Comments and recommendations on the proposed information collection should be emailed to Ms. Stephanie Tatham, DoD Desk Officer, at
You may also submit comments and recommendations, identified by Docket ID number and title, by the following method:
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Written requests for copies of the information collection proposal should be sent to Mr. Licari at WHS/ESD Directives Division, 4800 Mark Center Drive, East Tower, Suite 03F09, Alexandria, VA 22350-3100.
Department of the Navy, DOD.
Notice of open meeting.
The Ocean Research Advisory Panel (ORAP) will hold a regularly scheduled meeting. The meeting will be open to the public.
The meeting will be held on Wednesday, January 11, 2017 from 9:00 a.m. to 11:00 a.m., Eastern Time. Members of the public should submit their comments in advance of the meeting to the meeting Point of Contact. Due to circumstances beyond the control of the Designated Federal Officer and the Department of Defense, the Ocean Research Advisory Panel was unable to provide public notification of its meeting of January 11, 2017, as required by 41 CFR 102-3.150(a). Accordingly, the Advisory Committee Management Officer for the Department of Defense, pursuant to 41 CFR 102-3.150(b), waives the 15-calendar day notification requirement.
This will be a teleconference. For access, connect to:
CDR Joel W. Feldmeier, Office of Naval Research, 875 North Randolph Street Suite 1425, Arlington, VA 22203-1995, telephone 703-696-5121.
This notice of open meeting is provided in accordance with the Federal Advisory Committee Act (5 U.S.C. App. 2). The meeting will include discussions on ocean research, resource management, and other current issues in the ocean science and management communities.
Department of the Navy, DoD.
Notice.
The inventions listed below are assigned to the United States Government, as represented by the Secretary of the Navy and are available for domestic and foreign licensing by the Department of the Navy.
The following patents are available for licensing: Patent No. 9,536,620 (Navy Case No. 200321): METHOD AND SYSTEM FOR IMPROVING THE RADIATION TOLERANCE OF FLOATING GATE MEMORIES// and Patent No. 9,535,562 (Navy Case No. 101979): COGNITIVE LOAD REDUCTION AND FIELD OF VIEW ENHANCING STANDARDIZED GRAPHICAL USER INTERFACE (GUI) OVERLAY GENERATING SYSTEM OR SYSTEMS THAT INCLUDE ELEMENTS THAT CORRELATE VARIOUS DEVICE, EVENT, OR OPERATION INPUTS WITH COMMON GUI OVERLAY GENERATION MODULES AND GROUP RELATED GUI ELEMENTS ACROSS OVERLAYS ALONG WITH ASSOCIATED METHODS.
Requests for copies of the patents cited should be directed to Naval Surface Warfare Center, Crane Div, Code OOL, Bldg 2, 300 Highway 361, Crane, IN 47522-5001.
Mr. Christopher Monsey, Naval Surface Warfare Center, Crane Div, Code OOL, Bldg 2, 300 Highway 361, Crane, IN 47522-5001, Email
35 U.S.C. 207, 37 CFR part 404.
Office of Nuclear Energy, Department of Energy.
Notice of open meeting.
This notice announces a meeting of the Nuclear Energy Advisory Committee (NEAC). Federal Advisory Committee Act (Pub. L. 94-463, 86 Stat. 770) requires that public notice of these meetings be announced in the
Thursday, February 16, 2017.
4:00 p.m.-5:00 p.m. (EST).
The public teleconference will be held by teleconference only. The teleconference number is: (267) 930-4000; participation code: 580-520-181.
Bob Rova, Designated Federal Officer, U.S. Department of Energy, 19901 Germantown Rd, Germantown, MD 20874; telephone (301) 903-9096; email
Issued in Washington, DC, on January 11, 2017.
Environmental Protection Agency (EPA).
Notice of final action denying petitions for reconsideration and petitions for administrative stay.
The U.S. Environmental Protection Agency (EPA) received 38 petitions for reconsideration of the final Carbon Pollution Emission Guidelines for Existing Stationary Sources: Electric Utility Generating Units, published in the
The EPA took final action to deny the petitions for reconsideration except to the extent they raised certain topics, and to deny petitions for an administrative stay, on January 11, 2017.
Joseph Goffman, Office of Air and Radiation (6101A), U.S. EPA, 1200 Pennsylvania Avenue NW., Washington, DC 20460; telephone number (202)564-7400, facsimile number (202) 564-1408; email address:
A copy of this
Section 307(b)(1) of the Clean Air Act (CAA) specifies which Federal Courts of Appeal have venue over petitions for review of final EPA actions. This section provides, in part, that “a petition for review of action of the Administrator in promulgating . . . any standard of performance or requirement under section [111] of [the CAA],” or any other “nationally applicable” final action, “may be filed only in the United States Court of Appeals for the District of Columbia.”
The EPA has determined that its actions denying the petitions for reconsideration or for an administrative stay are nationally applicable for purposes of CAA section 307(b)(1) because the action directly affects the Emission Guidelines for Greenhouse Gas Emissions and Compliance Times for Electric Utility Generating Units, which are nationally applicable CAA section 111 standards. Thus, any petitions for review of the EPA's decision to deny petitioners' requests for reconsideration or for an administrative stay must be filed in the United States Court of Appeals for the District of Columbia by March 20, 2017.
On October 23, 2015, pursuant to section 111 of the CAA, the EPA published the final rule titled “Carbon Pollution Emission Guidelines for Existing Stationary Sources: Electric Utility Generating Units.” 80 FR 64661. Following promulgation of the final emission guidelines, the Administrator received petitions for reconsideration of certain provisions of the final rule pursuant to CAA section 307(d)(7)(B) and petitions for an administrative stay under the Administrative Procedure Act (APA), 5 U.S.C. 705 and CAA section 307(d)(7)(B).
CAA section 307(d)(7)(B) requires the EPA to convene a proceeding for reconsideration of a rule if a party raising an objection to the rule “can demonstrate to the Administrator that it was impracticable to raise such objection within [the public comment period] or if the grounds for such objection arose after the period for public comment (but within the time specified for judicial review) and if such objection is of central relevance to the outcome of the rule.” The requirement to convene a proceeding to reconsider a rule is thus based on the petitioner demonstrating to the EPA both: (1) That it was impracticable to raise the objection during the comment period, or that the grounds for such objection arose after the comment period, but within the time specified for judicial review (
The EPA received 38 petitions for reconsideration of the CAA section 111(d) greenhouse gas emission guidelines from the following entities: Alabama Department of Environmental Management (DEM); Ameren Corporation (Ameren); American Electric Power System (AEP); Arkansas Office of the Attorney General (Arkansas); Basin Electric Power Cooperative (Basin); Biogenic CO
In letters to petitioners, the EPA denied 31 of the petitions for reconsideration in full, and denied Kentucky's and Oglethorpe's petition for reconsideration except to the extent they raised the topic of biomass, as not satisfying one or both of the statutory conditions for compelled reconsideration. The EPA is deferring action on the petitions to the extent they cover the topics of biomass and waste-to-energy.
We discuss each of the topics in the petitions we denied and the basis for those denials in a separate, docketed memorandum titled “Basis for Denial of Petitions to Reconsider and Petitions to Stay the CAA Section 111(d) Emission Guidelines for Greenhouse Gas Emissions and Compliance Times for Electric Utility Generating Units.” For reasons set out in the memorandum, the EPA denied the petitions for reconsideration for the following petitioners: Alabama DEM; Ameren; AEP; Arkansas; Basin; Kentucky
APA section 705 provides, “When an agency finds that justice so requires, it may postpone the effective date of action taken by it, pending judicial review.” 5 U.S.C. 705. Under CAA section 307(d)(7)(B), the EPA may stay the effectiveness of a rule while it is being reconsidered “for a period not to exceed three months.”
The EPA received 22 petitions for an administrative stay under APA section 705 and CAA section 307(d)(7)(B).
The EPA received petitions from West Virginia and a group of 15 other states; Ameren; Basin; Business Associations; Denbury; Kansas DHE; Mississippi DEQ; Mississippi PSC; Montana; NAFO; National Mining Association; Nebraska; New Jersey DEP; North Dakota; NorthWestern Energy; Peabody Energy Corporation; Prairie State; Texas; UARG; and Westar Energy.
The EPA responded to several of these petitions by letters stating that we were not taking action on them in light of the stay imposed on the rule by the U.S. Supreme Court on February 7, 2016. Subsequently, the EPA sent letters to all the petitioners denying each of these petitions for the reasons explained in the memorandum referred to above, “Basis for Denial of Petitions to Reconsider and Petitions to Stay the CAA Section 111(d) Emission Guidelines for Greenhouse Gas Emissions and Compliance Times for Electric Utility Generating Units.”
Environmental Protection Agency (EPA).
Notice of proposed consent decree; request for public comment.
In accordance with section 113(g) of the Clean Air Act, as amended (“CAA” or the “Act”), notice is hereby given of a proposed consent decree to address a lawsuit filed by the Center for Biological Diversity and the Center for Environmental Health (collectively “Plaintiffs”) in the United States District Court for the Northern District of California:
Written comments on the proposed consent decree must be received by February 16, 2017.
Submit your comments, identified by Docket ID number EPA-HQ-OGC-2016-0719, online at
Melina Williams, Air and Radiation Law Office (2344A), Office of General Counsel, U.S. Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460; telephone: (202) 564-3406; fax number: (202) 564-5603; email address:
Under section 109(d) of the CAA, EPA is required to periodically review air quality criteria and NAAQS and to make such revisions as may be appropriate. The proposed consent decree addresses a lawsuit filed by Plaintiffs alleging that EPA failed to timely complete certain periodic reviews for NO
For a period of thirty (30) days following the date of publication of this notice, the Agency will accept written comments relating to the proposed consent decree from persons who were not named as parties or intervenors to the litigation in question. EPA or the Department of Justice may withdraw or withhold consent to the proposed consent decree if the comments disclose facts or considerations that indicate that such consent is inappropriate, improper, inadequate, or inconsistent with the requirements of the Act. Unless EPA or the Department of Justice determines that consent to this consent decree should be withdrawn, the terms of the decree will be affirmed.
The official public docket for this action (identified by Docket ID No.
An electronic version of the public docket is available through
It is important to note that EPA's policy is that public comments, whether submitted electronically or in paper, will be made available for public viewing online at
You may submit comments as provided in the
If you submit an electronic comment, EPA recommends that you include your name, mailing address, and an email address or other contact information in the body of your comment and with any disk or CD ROM you submit. This ensures that you can be identified as the submitter of the comment and allows EPA to contact you in case EPA cannot read your comment due to technical difficulties or needs further information on the substance of your comment. Any identifying or contact information provided in the body of a comment will be included as part of the comment that is placed in the official public docket, and made available in EPA's electronic public docket. If EPA cannot read your comment due to technical difficulties and cannot contact you for clarification, EPA may not be able to consider your comment.
Use of the
Environmental Protection Agency.
Notice of decision.
The Environmental Protection Agency (“EPA”) is granting the California Air Resources Board's (“CARB's”) request for a waiver of Clean Air Act preemption for its On-Highway Heavy-Duty Vehicle In-Use Compliance program (“In-Use Regulation”). EPA is also confirming that CARB's amendments to its 2007 and Subsequent Model Year On-Highway Heavy-Duty Engines and Vehicles regulation (“2007 Amendments”) and CARB's amendments to its Truck Idling requirements (“Truck Idling Amendments”) are within the scope of previous waivers issued by EPA. The In-Use Regulation establishes a manufacturer-run in-use compliance program using portable emission measurement systems (“PEMS”). The 2007 Amendments specify the NO
Petitions for review must be filed by March 20, 2017.
EPA has established a docket for this action under Docket ID EPA-HQ-OAR-2016-0017. All documents relied upon in making this decision, including those submitted to EPA by CARB, are contained in the public docket. Publicly available docket materials are available either electronically through
EPA's Office of Transportation and Air Quality (“OTAQ”) maintains a Web page that contains general information on its review of California waiver and authorization requests. Included on that page are links to prior waiver
David Dickinson, Office of Transportation and Air Quality, U.S. Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Telephone: (202) 343-9256. Email:
On August 19, 2005, EPA granted California a waiver of preemption pursuant to section 209(b) of the CAA, 42 U.S.C. 7543(b), for CARB's amendments to its heavy-duty diesel engine standards for 2007 and subsequent model year (MY) vehicles and engines and related test procedures, including not-to-exceed (“NTE”) and supplemental steady-state tests to determine compliance with applicable standards (“2007 California HDDE standards”).
CARB's In-Use Regulation establishes a manufacturer-run in-use compliance program that is largely identical to EPA's previously adopted heavy-duty in-use testing program (“HDIUT program”) originally adopted in 2005.
CARB initially adopted the 2007 California HDDE standards in 2001 to fully align California's NO
In 2008 CARB adopted amendments to the new engine requirements within the Truck Idling regulation to address specific issues regarding armored cars and workover rigs. Specifically, the Truck Idling Amendments provide that new 2008 and subsequent MY heavy-duty diesel engines used in armored cars and workover rigs are exempt from the new engine idling requirements. In addition, in 2011 CARB provided additional regulatory clarification of the exemption.
By letter dated January 27, 2016, CARB submitted to EPA a request for a waiver of the preemption found at section 209(a) of Clean Air Act, 42 U.S.C. 7543(a), for the In-Use Regulation. CARB's submission provided analysis and evidence to support its finding that the In-Use Regulation satisfies the CAA section 209(b) criteria and that a waiver of preemption should be granted. CARB's request also sought confirmation that its 2007 Amendments and the Truck Idling Amendments are within the scope of waivers of preemption previously granted by EPA.
Section 209(a) of the CAA provides:
No State or any political subdivision thereof shall adopt or attempt to enforce any
Section 209(b)(1) of the Act requires the Administrator, after an opportunity for public hearing, to waive application of the prohibitions of section 209(a) for any state that has adopted standards (other than crankcase emission standards) for the control of emissions from new motor vehicles or new motor vehicle engines prior to March 30, 1966, if the state determines that its state standards will be, in the aggregate, at least as protective of public health and welfare as applicable federal standards.
Key principles governing this review are that EPA should limit its inquiry to the specific findings identified in section 209(b)(1) of the Clean Air Act, and that EPA will give substantial deference to the policy judgments California has made in adopting its regulations. In previous waiver decisions, EPA has stated that Congress intended the Agency's review of California's decision-making to be narrow. EPA has rejected arguments that are not specified in the statute as grounds for denying a waiver:
The law makes it clear that the waiver requests cannot be denied unless the specific findings designated in the statute can properly be made. The issue of whether a proposed California requirement is likely to result in only marginal improvement in California air quality not commensurate with its costs or is otherwise an arguably unwise exercise of regulatory power is not legally pertinent to my decision under section 209, so long as the California requirement is consistent with section 202(a) and is more stringent than applicable Federal requirements in the sense that it may result in some further reduction in air pollution in California.
This principle of narrow EPA review has been upheld by the U.S. Court of Appeals for the District of Columbia Circuit.
If California amends regulations that have been previously authorized by EPA, California may ask EPA to determine that the amendments are within the scope of the earlier authorization. A within-the-scope determination for such amendments is permissible without a full authorization review if three conditions are met. First, the amended regulations must not undermine California's previous determination that its standards, in the aggregate, are as protective of public health and welfare as applicable federal standards. Second, the amended regulations must not affect consistency with section 209 of the Act, following the same criteria discussed above in the context of full authorizations. Third, the amended regulations must not raise any new issues affecting EPA's prior waiver or authorization decisions.
As the U.S. Court of Appeals for the D.C. Circuit has made clear in
[T]he language of the statute and its legislative history indicate that California's regulations, and California's determinations that they must comply with the statute, when presented to the Administrator are presumed to satisfy the waiver requirements and that the burden of proving otherwise is on whoever attacks them. California must present its regulations and findings at the hearing and thereafter the parties opposing the waiver request bear the burden of persuading the Administrator that the waiver request should be denied.
The Administrator's burden, on the other hand, is to make a reasonable evaluation of the information in the record in coming to the waiver decision. As the court in
With regard to the standard of proof, the court in
With regard to the protectiveness finding, the court upheld the Administrator's position that, to deny a waiver, there must be “clear and compelling evidence” to show that proposed enforcement procedures undermine the protectiveness of California's standards.
With respect to the consistency finding, the court did not articulate a standard of proof applicable to all proceedings, but found that the opponents of the waiver were unable to meet their burden of proof even if the standard were a mere preponderance of the evidence. Although
In previous waiver decisions, EPA has recognized that the intent of Congress in creating a limited review based on specifically listed criteria was to ensure that the federal government did not second-guess state policy choices. As the Agency explained in one prior waiver decision:
It is worth noting . . . I would feel constrained to approve a California approach to the problem which I might also feel unable to adopt at the federal level in my own capacity as a regulator. . . . Since a balancing of risks and costs against the potential benefits from reduced emissions is a central policy decision for any regulatory agency under the statutory scheme outlined above, I believe I am required to give very substantial deference to California's judgments on this score.
Similarly, EPA has stated that the text, structure, and history of the California waiver provision clearly indicate both a congressional intent and appropriate EPA practice of leaving the decision on “ambiguous and controversial matters of public policy” to California's judgment.
On August 9, 2016, EPA published a notice of opportunity for public hearing and comment on California's waiver request.
EPA received no comments and no requests for a public hearing. Consequently, EPA did not hold a public hearing.
EPA initially evaluates California's 2007 Amendments and Truck Idling Amendments by application of our traditional within-the-scope analysis, as CARB requested. If we determine that CARB's request does not meet the requirements for a within-the-scope determination, we then evaluate the request based on a full authorization analysis. In determining whether amendments can be viewed as within the scope of previous waivers, EPA looks at whether CARB's revision is either limited to minor technical amendments to previously waived regulations or modifying regulations in order to provide additional compliance flexibility without significantly reducing the overall stringency of previously waived regulations. The amendments at issue in this request provide regulatory clarity and corrections, and provide limited exemptions in order to provide for compliance flexibility
EPA sought comment on a range of issues, including those applicable to a within-the-scope analysis as well as those applicable to a full authorization analysis. No party submitted a comment that California's 2007 Amendments or Truck Idling Amendments require a full authorization analysis. Given the lack of comments on this issue, and EPA's assessment of the nature of the amendments, I will evaluate California's 2007 amendments and Truck Idling Amendments by application of the traditional within-the-scope analysis, as CARB requested.
As noted above, EPA can confirm that the amended regulations are within the scope of a previously granted waiver of preemption if three conditions are met. First, the amended regulations do not undermine California's determination that its standards, in the aggregate, are as protective of public health and welfare as applicable federal standards. Second, the amended regulations do not affect consistency with section 202(a) of the Act. Third, the amended regulations do not raise any “new issues” affecting EPA's prior authorizations.
CARB's waiver request also included the In-Use Regulation. EPA must grant a waiver for the In-Use Regulation unless the Administrator finds: (1) California's determination that its standards will be, in the aggregate, as protective of public health and welfare as applicable federal standards is arbitrary and capricious; (2) California does not need such California standards to meet compelling and extraordinary conditions; or (3) California's standards and accompanying enforcement procedures are not consistent with this section.
EPA's evaluation of the 2007 Amendments, the Truck Idling Amendments, and the In-use Regulation is set forth below. Because of the similarity of the within-the-scope criteria and the full waiver criteria, a discussion of all three sets of respective amendments take place within each waiver criterion. To the extent that the
As stated in the background, section 209(b)(1)(A) of the Act sets forth the first of the three criteria governing a new waiver request—whether California was arbitrary and capricious in its determination that its motor vehicle emissions standards will be, in the aggregate, at least as protective of public health and welfare as applicable federal standards. Section 209(b)(1)(A) of the CAA requires EPA to deny a waiver if the Administrator finds that California's protectiveness determination was arbitrary and capricious. However, a finding that California's determination was arbitrary and capricious must be based upon clear and convincing evidence that California's finding was unreasonable.
CARB notes that in its initial adoption and amendments to the In-Use Regulation in 2006, 2007, and 2011, the CARB Board approved Resolutions 06-27, 07-56 and 11-19 in which it declared:
As it is clear that California's standards are at least as protective of public health and welfare as applicable federal standards, and that no evidence is in the record suggesting otherwise (and EPA is not otherwise aware of any information), I find that California's respective protectiveness determinations are not arbitrary and capricious for purposes of the In-Use Regulation, the 2007 Amendments, and the Truck Idling Amendments.
Section 209(b)(1)(B) instructs that EPA cannot grant a waiver if the Agency finds that California “does not need such State standards to meet compelling and extraordinary conditions.” EPA's inquiry under this second criterion has traditionally been to determine whether California needs its own motor vehicle emission control program (
In conjunction with the initial adoption and subsequent amendments of the In-Use Regulation in 2006, 2007, and 2011, respectively (see Resolutions 06-27, 07-56, and 11-19 noted above), the CARB's Board confirmed California's longstanding position that California continues to need its own motor vehicle emission program to meet serious air pollution problems. CARB notes that the geographical and climatic conditions and the tremendous growth in vehicle population and use that moved Congress to authorize California to establish separate vehicle standards in 1967 still exist today.
There has been no evidence submitted to indicate that California's compelling and extraordinary conditions do not continue to exist. California, particularly in the South Coast and San Joaquin Valley air basins, continues to experience some of the worst air quality in the nation, and many areas in California continue to be in non-attainment with national ambient air quality standards for fine particulate matter and ozone.
Based on the record before us, including EPA's prior waiver decisions, I am unable to identify any change in circumstances or evidence to suggest that the conditions that Congress identified as giving rise to serious air quality problems in California no longer exist. Therefore, EPA cannot find that California does not need its state standards, including its In-Use
For the third and final criterion, EPA evaluates the program for consistency with section 202(a) of the CAA. Under section 209(b)(1)(C) of the CAA, EPA must deny California's waiver request if EPA finds that California's standards and accompanying enforcement procedures are not consistent with section 202(a). Section 202(a) requires that regulations “shall take effect after such period as the Administrator finds necessary to permit the development and application of the relevant technology, considering the cost of compliance within that time.”
EPA has previously stated that the determination is limited to whether those opposed to the waiver have met their burden of establishing that California's standards are technologically infeasible, or that California's test procedures impose requirements inconsistent with the federal test procedure. Infeasibility would be shown here by demonstrating that there is inadequate lead time to permit the development of technology necessary to meet the In-Use Amendments, the 2007 Amendments, or the Truck Idling Amendments that are the subject of the waiver request, giving appropriate consideration to the cost of compliance within that time.
Regarding test procedure conflict, CARB notes both EPA and CARB utilize essentially identical test procedures in certifying 2007 and subsequent MY heavy-duty engines and that the 2007 Amendments also do not preclude manufacturers from conducting one set of tests on a heavy-duty engines or vehicle to determine compliance with both the California and federal requirements.
In addition, EPA did not receive any comments arguing that the CARB's In-Use Regulation, 2007 Amendments, and Truck Idling Amendments were technologically infeasible or that the cost of compliance would be excessive, such that California's standards might be inconsistent with section 202(a).
I therefore cannot find that California standards, which include the CARB's In-Use Regulation, 2007 Amendments, and Truck Idling Amendments are inconsistent with section 202(a).
EPA has stated in the past that if California promulgates amendments that raise new issues affecting previously granted waivers, we would not confirm that those amendments are within the scope of previous waivers.
After evaluating CARB's In-Use Regulation and CARB's submissions for EPA review, I am hereby granting a waiver for the In-Use Regulation. After evaluating CARB's 2007 Amendments and Truck Idling Amendments and CARB's submissions for EPA review, I am hereby confirming that such amendments are within the scope of prior EPA waivers.
This decision will affect persons in California and those manufacturers and/or owners/operators nationwide who must comply with California's requirements. In addition, because other states may adopt California's standards for which a section 209(b) waiver has been granted under section 177 of the Act if certain criteria are met, this decision would also affect those states and those persons in such states. For these reasons, EPA determines and finds that this is a final action of national applicability, and also a final action of nationwide scope or effect for purposes of section 307(b)(1) of the Act. Pursuant to section 307(b)(1) of the Act, judicial review of this final action may be sought only in the United States Court of Appeals for the District of Columbia Circuit. Petitions for review must be filed by March 20, 2017. Judicial review of this final action may not be obtained in subsequent enforcement proceedings, pursuant to section 307(b)(2) of the Act.
As with past waiver and authorization decisions, this action is not a rule as defined by Executive Order 12866. Therefore, it is exempt from review by the Office of Management and Budget as required for rules and regulations by Executive Order 12866.
In addition, this action is not a rule as defined in the Regulatory Flexibility Act, 5 U.S.C. 601(2). Therefore, EPA has not prepared a supporting regulatory flexibility analysis addressing the impact of this action on small business entities.
Further, the Congressional Review Act, 5 U.S.C. 801,
Federal Communications Commission.
Notice and request for comments.
As part of its continuing effort to reduce paperwork burdens, and as required by the Paperwork Reduction Act (PRA) of 1995, the Federal Communications Commission (FCC or Commission) invites the general public and other Federal agencies to take this opportunity to comment on the following information collections. Comments are requested concerning: Whether the proposed collection of information is necessary for the proper performance of the functions of the Commission, including whether the information shall have practical utility; the accuracy of the Commission's burden estimate; ways to enhance the quality, utility, and clarity of the information collected; ways to minimize the burden of the collection of information on the respondents, including the use of automated collection techniques or other forms of information technology; and ways to further reduce the information collection burden on small business concerns with fewer than 25 employees.
The FCC may not conduct or sponsor a collection of information unless it displays a currently valid OMB control number. No person shall be subject to any penalty for failing to comply with a collection of information subject to the PRA that does not display a valid OMB control number.
Written PRA comments should be submitted on or before March 20, 2017. If you anticipate that you will be submitting comments, but find it difficult to do so within the period of time allowed by this notice, you should advise the contact listed below as soon as possible.
Direct all PRA comments to Nicole Ongele, FCC, via email to
For additional information about the information collection, contact Nicole Ongele at (202) 418-2991.
Federal Communications Commission.
Notice and request for comments.
As part of its continuing effort to reduce paperwork burdens, and as required by the Paperwork Reduction Act (PRA) of 1995, the Federal Communications Commission (FCC or Commission) invites the general public and other Federal agencies to take this opportunity to comment on the following information collections. Comments are requested concerning: Whether the proposed collection of information is necessary for the proper performance of the functions of the Commission, including whether the information shall have practical utility; the accuracy of the Commission's burden estimate; ways to enhance the quality, utility, and clarity of the information collected; ways to minimize the burden of the collection of information on the respondents, including the use of automated collection techniques or other forms of information technology; and ways to further reduce the information collection burden on small business concerns with fewer than 25 employees.
The FCC may not conduct or sponsor a collection of information unless it displays a currently valid OMB control number. No person shall be subject to any penalty for failing to comply with a collection of information subject to the PRA that does not display a valid OMB control number.
Written PRA comments should be submitted on or before March 20, 2017. If you anticipate that you will be submitting comments, but find it difficult to do so within the period of time allowed by this notice, you should advise the contact listed below as soon as possible.
Direct all PRA comments to Cathy Williams, FCC, via email
For additional information about the information collection, contact Cathy Williams at (202) 418-2918.
The information collection requirements contained in 47 Section 95.861(e) require that each 218-219 MHz service licensee investigate and eliminate harmful interference to television broadcasting and reception, from its component cell transmitter stations (CTSs) and response transmitter units (RTUs) within 30 days of the time it is notified in writing, by either an affected television station, an affected viewer, or the Commission, of an interference complaint.
This information will be used to monitor the co- and adjacent channel interference potential of proposed systems in the 218-219 MHz service, and to identify methods being used to minimize interference, as well as to show how the proposed systems will meet the service requirements set forth in § 95.831 of the Commission's rules.
Federal Communications Commission.
Notice and request for comments.
As part of its continuing effort to reduce paperwork burdens, and as required by the Paperwork Reduction Act (PRA) of 1995, the Federal Communications Commission (FCC or Commission) invites the general public and other Federal agencies to take this opportunity to comment on the following information collections. Comments are requested concerning: Whether the proposed collection of information is necessary for the proper performance of the functions of the Commission, including whether the information shall have practical utility;
The FCC may not conduct or sponsor a collection of information unless it displays a currently valid OMB control number. No person shall be subject to any penalty for failing to comply with a collection of information subject to the PRA that does not display a valid OMB control number.
Written comments should be submitted on or before February 16, 2017. If you anticipate that you will be submitting comments, but find it difficult to do so within the period of time allowed by this notice, you should advise the contacts below as soon as possible.
Direct all PRA comments to Nicholas A. Fraser, OMB, via email
For additional information or copies of the information collection, contact Nicole Ongele at (202) 418-2991.
To view a copy of this information collection request (ICR) submitted to OMB: (1) Go to the Web page <
These recordkeeping and reporting requirements have potential to increase emergency managers' confidence that WEA will work as intended when needed. This increased confidence in system availability will encourage emergency managers that do not currently use WEA to become authorized. These reporting and recordkeeping requirements also help to ensure a fundamental component of system integrity. Alert logs are necessary to establish a baseline for system integrity against which future iterations of WEA can be evaluated. Without records that can be used to describe the quality of system integrity, and the most common causes of message transmission failure, it will be difficult to evaluate how any changes to WEA that we may adopt subsequent to this
Federal Communications Commission.
Notice and request for comments.
As part of its continuing effort to reduce paperwork burdens, and as required by the Paperwork Reduction Act (PRA) of 1995, the Federal Communication Commission (FCC or Commission) invites the general public and other Federal agencies to take this opportunity to comment on the following information collections. Comments are requested concerning: Whether the proposed collection of information is necessary for the proper performance of the functions of the Commission, including whether the information shall have practical utility; the accuracy of the Commission's burden estimate; ways to enhance the quality, utility, and clarity of the information collected; ways to minimize
The FCC may not conduct or sponsor a collection of information unless it displays a currently valid OMB control number. No person shall be subject to any penalty for failing to comply with a collection of information subject to the PRA that does not display a valid OMB control number.
Written comments should be submitted on or before February 16, 2017. If you anticipate that you will be submitting comments, but find it difficult to do so within the period of time allowed by this notice, you should advise the contacts below as soon as possible.
Direct all PRA comments to Nicholas A. Fraser, OMB, via email
For additional information or copies of the information collection, contact Cathy Williams at (202) 418-2918. To view a copy of this information collection request (ICR) submitted to OMB: (1) Go to the Web page
The National Do-Not-Call Registry supplements the company-specific do-not-call rules for those consumers who wish to continue requesting that particular companies not call them. Any company that is asked by a consumer, including an existing customer, not to call again must honor that request for five (5) years.
A provision of the Commission's rules, however, allows consumers to give specific companies permission to call them through an express written agreement. Nonprofit organizations are exempt from the Do-Not-Call Registry requirements.
On September 21, 2004, the Commission released the
On June 17, 2008, in accordance with the Do-Not-Call Improvement Act of 2007, the Commission revised its rules to minimize the inconvenience to consumers of having to re-register their preferences not to receive telemarketing calls and to further the underlying goal of the National Do-Not-Call Registry to protect consumer privacy rights. The Commission released a
On February 15, 2012, the Commission released a
On August 11, 2016, the Commission released a
Federal Communications Commission.
Notice and request for comments.
As part of its continuing effort to reduce paperwork burdens, and as required by the Paperwork Reduction Act (PRA) of 1995, the Federal Communications Commission (FCC or Commission) invites the general public and other Federal agencies to take this opportunity to comment on the following information collections. Comments are requested concerning: Whether the proposed collection of information is necessary for the proper performance of the functions of the Commission, including whether the information shall have practical utility; the accuracy of the Commission's burden estimate; ways to enhance the quality, utility, and clarity of the information collected; ways to minimize the burden of the collection of information on the respondents, including the use of automated collection techniques or other forms of information technology; and ways to further reduce the information collection burden on small business concerns with fewer than 25 employees.
The FCC may not conduct or sponsor a collection of information unless it displays a currently valid Office of Management and Budget (OMB) control number. No person shall be subject to any penalty for failing to comply with a collection of information subject to the PRA that does not display a valid OMB control number.
Written comments should be submitted on or before March 20, 2017. If you anticipate that you will be submitting comments, but find it difficult to do so within the period of time allowed by this notice, you should advise the contacts below as soon as possible.
Direct all PRA comments to Cathy Williams, FCC, via email
For additional information about the information collection, contact Cathy Williams at (202) 418-2918.
On October 29, 2013, in document FCC 13-138,
Covered entities are required to comply with the rules and information collection requirements contained in the
The Commission is submitting this revised information collection to transfer certain information collection burdens associated with this OMB Control Number 3060-1203 to OMB Control Number 3060-0874. This transfer is being made because the Commission's online consumer complaint portal, which is part of the information collection contained in OMB Control Number 3060-0874, is being revised to enable consumers to file complaints related to the Commission's user interfaces accessibility requirements through the Commission's online complaint portal.
Federal Communications Commission.
Notice and request for comments.
As part of its continuing effort to reduce paperwork burdens, and as required by the Paperwork Reduction Act (PRA) of 1995 (44 U.S.C. 3501-3520), the Federal Communications Commission (FCC or the Commission) invites the general public and other Federal agencies to take this opportunity to comment on the following information collection. Comments are requested concerning: Whether the proposed collection of information is necessary for the proper performance of the functions of the Commission, including whether the information shall have practical utility; the accuracy of the Commission's burden estimate; ways to enhance the quality, utility, and clarity of the information collected; ways to minimize the burden of the collection of information on the respondents, including the use of automated collection techniques or other forms of information technology; and ways to further reduce the information collection burden on small business concerns with fewer than 25 employees.
The Commission may not conduct or sponsor a collection of information unless it displays a currently valid Office of Management and Budget (OMB) control number. No person shall be subject to any penalty for failing to comply with a collection of information subject to the PRA that does not display a valid OMB control number.
Written comments should be submitted on or before February 16, 2017. If you anticipate that you will be submitting comments, but find it difficult to do so within the period of time allowed by this notice, you should advise the contacts listed below as soon as possible.
Direct all PRA comments to Nicholas A. Fraser, OMB, via email
For additional information or copies of the information collection, contact Cathy Williams at (202) 418-2918. To view a copy of this information collection request (ICR) submitted to OMB: (1) Go to the Web page
In addition, the Commission has adopted provisions that permit respondents subject to the information collection requirement for Shared Service Agreements to redact confidential or proprietary information from their disclosures.
This collection is being revised to reflect the burden associated with the Shared Service Agreement disclosure requirements adopted in the
This information collection requirement will provide the Commission and the public with more comprehensive information about the prevalence and content of Shared Service Agreements between television stations, which will improve the Commission's and the public's ability to assess the potential impact of these agreements on the Commission's rules and policies.
The information collection requirements contained under 47 CFR 73.1212, 73.3527, 73.1943 and 76.1701 are still a part of the information collection and remain unchanged since last approved by OMB.
Based upon the foregoing, the Receiver has determined that the continued existence of the receivership will serve no useful purpose. Consequently, notice is given that the receivership shall be terminated, to be effective no sooner than thirty days after the date of this Notice. If any person wishes to comment concerning the termination of the receivership, such comment must be made in writing and sent within thirty days of the date of this Notice to: Federal Deposit Insurance Corporation, Division of Resolutions and Receiverships, Attention: Receivership Oversight Department 34.6, 1601 Bryan Street, Dallas, TX 75201.
No comments concerning the termination of this receivership will be considered which are not sent within this time frame.
Federal Election Commission
Thursday, January 12, 2017 at the conclusion of the 10:00 a.m. open meeting.
999 E Street NW., Washington, DC.
This meeting was closed to the public.
Internal personnel rules and internal rules and practices.
Judith Ingram, Press Officer, Telephone: (202) 694-1220.
Board of Governors of the Federal Reserve System.
The Board of Governors of the Federal Reserve System (Board or Federal Reserve) is adopting a proposal to extend for three years, without revision the following reporting and recordkeeping requirements related to amendments made by the Gramm-Leach-Bliley Act, to the Bank Holding Company Act, the Federal Reserve Act, and related regulations. On June 15, 1984, the Office of Management and Budget (OMB) delegated to the Board of Governors of the Federal Reserve System (Board) its approval authority under the Paperwork Reduction Act (PRA), to approve of and assign OMB numbers to collection of information requests and requirements conducted or sponsored by the Board. Board-approved collections of information are incorporated into the official OMB inventory of currently approved collections of information. Copies of the PRA Submission, supporting statements and approved collection of information instruments are placed into OMB's public docket files. The Federal Reserve may not conduct or sponsor, and the respondent is not required to respond to, an information collection that has been extended, revised, or implemented on or after October 1, 1995, unless it displays a currently valid OMB number.
Federal Reserve Board Clearance Officer—Nuha Elmaghrabi—Office of the Chief Data Officer, Board of Governors of the Federal Reserve System, Washington, DC 20551 (202) 452-3884. Telecommunications Device for the Deaf (TDD) users may contact (202) 263-4869, Board of Governors of the Federal Reserve System, Washington, DC 20551.
OMB Desk Officer—Shagufta Ahmed—Office of Information and Regulatory Affairs, Office of Management and Budget, New Executive Office Building, Room 10235, 725 17th Street NW., Washington, DC 20503.
The Board is adopting a proposal to extend for three years, without revision the following reporting and recordkeeping requirements related to amendments made by the Gramm-Leach-Bliley Act, to the Bank Holding Company Act, the Federal Reserve Act, and related regulations:
• The mandatory Declarations to Become a Financial Holding Company (FHC) (FR 4010);
• The voluntary Requests for Determinations and Interpretations Regarding Activities Financial in Nature (FR 4011);
• The mandatory Notices of Failure to Meet Capital or Management Requirements (FR 4012);
• The mandatory Notices by State Member Banks to Invest in Financial Subsidiaries (FR 4017);
• The mandatory Regulatory Relief Requests Associated with Merchant Banking Activities (FR 4019); and
• The mandatory Recordkeeping Requirements Associated with Merchant Banking Activities (FR 4023).
These collections of information are event-generated and as such, there are no formal reporting forms associated
• FR 4010 is authorized by section 4(
• FR 4011 is authorized by section 4(j) and (k) of the BHC Act (12 U.S.C. 1843(j)-(k)), and sections 225.88 and 225.89 of the Board's Regulation Y (12 CFR 225.88, 225.89).
• FR 4012 is authorized by section 4(
• FR 4017 is authorized by section 9 of the FRA (12 U.S.C. 335), and section 208.76 of the Board's Regulation H (12 CFR 208.76).
• FR 4019 is authorized by section 4(k)(7) of the BHC Act (12 U.S.C. 1843(k)(7)); sections 225.171(e)(3), 225.172(b)(4); and section 225.173(c)(2) of the Board's Regulation Y (12 CFR 225.171(e)(3), 225.172(b)(4), 225.173(c)(2)).
• FR 4023 is authorized by section 4(k)(7) of the BHC Act (12 U.S.C. 1843(k)(7)), and sections 225.171(e)(4) and 225.175 of the Board's Regulation Y (12 CFR 225.171(e)(4), 225.175).
The obligation to respond to the FR 4011 is voluntary (for requests to determine that an activity is financial in nature or to issue an advisory opinion that an activity is within the scope of an activity previously determined to be financial in nature) and required to obtain or retain benefits (for approvals to engage in an activity that is complementary to a financial activity). The obligation to respond to the FR 4010, FR 4017, and FR 4019 is required to obtain or retain benefits. The obligation to respond to FR 4012 and the obligation to comply with the recordkeeping requirements of the FR 4023 is mandatory.
The information collected on the FR 4010, FR 4011, FR 4017, and FR 4019 and information related to a failure to meet capital requirements on the FR 4012 is not generally considered confidential. Nevertheless, a respondent may request confidential treatment of information contained in these information collections in accordance with section (b)(4) or (b)(6) of the Freedom of Information Act (FOIA) (5 U.S.C. 552(b)(4), (b)(6)). Any request for confidential treatment of information must be accompanied by a detailed justification for confidentiality. Information related to a failure to meet management requirements on the FR 4012 is considered confidential and exempt from disclosure under section (b)(4), because the release of this information would cause substantial harm to the competitive position of the entity, and section (b)(8), if the information is related to examination, operating, or condition reports prepared by, on behalf of, or for the use of an agency responsible for the regulation or supervision of financial institutions (5 U.S.C. 552(b)(4), (b)(8)).
Additionally, the records kept in accordance with the Recordkeeping Requirements Associated with Merchant Banking Activities are retained by the respondent itself and the FOIA would only be implicated if the Board's examiners retained a copy of the records as part of an examination or supervision of a banking institution. In this case, the records would likely be exempt from disclosure under exemption (b)(8), for examination material. 5 U.S.C. 552(b)(8). In addition, the records may also be exempt under (b)(4) and (b)(6).
The BHC Act, and Regulations Y and LL specify the information to be included in a declaration.
An FHC declaration filed by a U.S. BHC must state that the BHC elects to become an FHC, must be signed by an authorized official or representative, and must provide the following information:
An FHC declaration filed by a U.S. SLHC must state that the SLHC elects to be treated as an FHC, must be signed by an authorized official or representative, and must provide the following information:
An FHC declaration filed by an FBO must state that the FBO elects to be treated as an FHC, must be signed by an authorized official or representative,
Regulation Y specifies the information to be collected in connection with each type of request.
A request for an advisory opinion that a specific activity is within the scope of activities previously determined to be financial in nature, or incidental to a financial activity, must be in writing and:
An applicant seeking prior approval to engage in an activity that the applicant believes is complementary to a financial activity must submit a written request that:
Regulation Y provides that the notice must identify the noncompliant banking entity and the area of noncompliance. Regulation Y does not prescribe a format for such notices, however, they typically take the form of a letter.
Regulation H requires FR 4017 notices to be in the form of a letter with enclosures and to:
Regulation Y requires requests for extension of the holding period for a merchant bank investment to include the following information:
A notice of extended routine management or operation of a portfolio company can be in the form of a brief letter and must identify the portfolio company, the date on which the FHC first became involved in the routine management or operation of the portfolio company, the reasons for the FHC's involvement, the actions taken by the FHC to address the circumstances giving rise to its involvement, and an estimate of when the FHC anticipates ceasing routinely managing or operating the portfolio company.
The general policies and procedures that an FHC must establish with respect to merchant banking must be reasonably designed to:
The companies listed in this notice have applied to the Board for approval, pursuant to the Bank Holding Company Act of 1956 (12 U.S.C. 1841
The applications listed below, as well as other related filings required by the Board, are available for immediate inspection at the Federal Reserve Bank indicated. The applications will also be available for inspection at the offices of the Board of Governors. Interested persons may express their views in writing on the standards enumerated in the BHC Act (12 U.S.C. 1842(c)). If the proposal also involves the acquisition of a nonbanking company, the review also includes whether the acquisition of the nonbanking company complies with the standards in section 4 of the BHC Act (12 U.S.C. 1843). Unless otherwise noted, nonbanking activities will be conducted throughout the United States.
Unless otherwise noted, comments regarding each of these applications must be received at the Reserve Bank indicated or the offices of the Board of Governors not later than February 10, 2017.
1.
In connection with this application, Applicant also has applied to acquire additional shares of Southern Trust Mortgage LLC, Virginia Beach, Virginia, Eastern Virginia Bankshares, Inc., Glen Allen, Virginia and EVB, Tappahannock, Virginia, and thereby engage in lending activities pursuant to section 225.28(b)(1) or Regulation Y.
Board of Governors of the Federal Reserve System.
Notice is hereby given of the final approval of a proposal to extend for three years, without revision, the intermittent survey of business (FR 1374; OMB No. 7100-0302) and to extend for three years, without revision, the domestic finance company report of consolidated assets and liabilities (FR 2248; OMB No. 7100-0005) by the Board of Governors of the Federal Reserve System (Board) under OMB delegated authority, as per 5 CFR 1320.16 (OMB Regulations on Controlling Paperwork Burdens on the Public). Board-approved collections of information are incorporated into the official OMB inventory of currently approved collections of information. Copies of the Paperwork Reduction Act Submission, supporting statements and approved collection of information instrument(s) are placed into OMB's public docket files. The Federal Reserve may not conduct or sponsor, and the respondent is not required to respond to, an information collection that has been extended, revised, or implemented on or after October 1, 1995, unless it displays a currently valid OMB control number.
Federal Reserve Board Acting Clearance Officer—Nuha Elmaghrabi—Office of the Chief Data Officer, Board of Governors of the Federal Reserve System, Washington, DC 20551 (202) 452-3829. Telecommunications Device for the Deaf (TDD) users may contact (202) 263-4869, Board of Governors of the Federal Reserve System, Washington, DC 20551.
OMB Desk Officer—Shagufta Ahmed—Office of Information and Regulatory Affairs, Office of Management and Budget, New Executive Office Building, Room 10235, 725 17th Street NW., Washington, DC 20503.
The Centers for Disease Control and Prevention (CDC) has submitted the following information collection request to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act of 1995. The notice for the proposed information collection is published to obtain comments from the public and affected agencies.
Written comments and suggestions from the public and affected agencies concerning the proposed collection of information are encouraged. Your comments should address any of the following: (a) Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility; (b) Evaluate the accuracy of the agencies estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (c) Enhance the quality, utility, and clarity of the information to be collected; (d) Minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology,
To request additional information on the proposed project or to obtain a copy of the information collection plan and instruments, call (404) 639-7570 or send an email to
Understanding the Needs, Challenges, Opportunities, Vision and Emerging Roles in Environmental Health (UNCOVER EH)—New—National Center for Environmental Health (NCEH), Centers for Disease Control and Prevention (CDC)
The environmental health (EH) workforce is an essential component of the public health workforce. According to recent health department surveys, EH professionals are employed at approximately 85% of local health departments, 81% of state health departments, and 30% of tribal health departments. Describing and characterizing the EH workforce is essential to identifying gaps in staffing, training, and ultimately ensuring EH professionals are prepared to meet future challenges. Because EH professionals play a crucial role in decreasing illness in our communities and protecting people from traditional and emerging environmental factors that may adversely affect human health, the workforce challenges facing this critical component of the public health system are a concern for public and community health. CDC's goal is to create a strong, sustained, and prepared EH workforce to meet today's challenges and improve the health and safety of all. In order to meet this goal, it is necessary to first
This is a one-time information collection designed to thoroughly describe the health department EH workforce on: (1) The current supply of EH professionals; (2) EH workforce demographics and professional roles; (3) gaps in current EH education and competencies and training needs; and (4) critical skills and resources needed to meet the evolving and emerging EH issues and challenges. This information will benefit the government and other entities by providing essential data to inform and support workforce development activities and initiatives and understand areas of practice and where gaps may exist in capacity to address current EH issues and future challenges.
The survey will be offered to the estimated 20,000 EH professionals working within health departments. They will be enumerated and recruited by identifying a point of contact in each state, local, tribal, and territorial health department from whom a roster of EH professionals will be requested. A list of respondents and their business email addresses will be generated and used for recruitment and survey administration. Any contact information collected will be related to the respondents' role in the organization. Participation will be voluntary. We expect approximately 80 percent of the estimated 20,000 EH professionals (16,000 respondents) to respond to the survey.
Data will be collected one time from a census of members of the public health department EH workforce using a web-based survey instrument. The UNCOVER EH Survey will take approximately 30 minutes to complete per respondent. There will be no cost to respondents other than their time. The requested time burden is 8,269 hours.
Centers for Disease Control and Prevention (CDC), Department of Health and Human Services (HHS).
Notice with comment period.
The Centers for Disease Control and Prevention (CDC), as part of its continuing efforts to reduce public burden and maximize the utility of government information, invites the general public and other Federal agencies to take this opportunity to comment on proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995. This notice invites comment on a proposed information collection titled “Assessment of the Market for Electronic Technology for Underground Coal Mining Safety and Health Applications.” From this information collection project, NIOSH seeks to provide insight into what the most important barriers are from the perspective of the organizations that must purchase, use, approve, and manufacture these safety technologies.
Written comments must be received on or before March 20, 2017.
You may submit comments, identified by Docket No. CDC-2017-0002 by any of the following methods:
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All public comment should be submitted through the Federal eRulemaking portal (
To request more information on the proposed project or to obtain a copy of the information collection plan and instruments, contact the Information Collection Review Office, Centers for Disease Control and Prevention, 1600 Clifton Road NE., MS-D74, Atlanta, Georgia 30329; phone: 404-639-7570; Email:
Under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3520), Federal agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. In addition, the PRA also requires Federal agencies to provide a 60-day notice in the
Assessment of the Market for Electronic Technology for Underground Coal Mining Safety and Health Applications—New—National Institute for Occupational Safety and Health (NIOSH), Centers for Disease Control and Prevention (CDC).
Underground coal mining in the U.S. is a relatively small industry (about 46,000 employees) that operates in a unique and hazardous work environment. The common presence of explosive gasses and other hazards creates special safety requirements for equipment, including safety and health protection technologies, used in underground coal mines. This request is for a 2-year approval period.
The MINER Act of 2006 assigned the National Institute for Occupational Safety and Health (NIOSH) the responsibility to enhance development of new mine safety and health protection technology and technological applications and to expedite the commercial availability and implementation of such technology. As part of this study, NIOSH seeks to identify the barriers to commercial availability and implementation of such technology in U.S. mines.
Experience to date has shown that there are many issues that the U.S. mining industry faces that create barriers to the availability and implementation of safety technologies, and we believe there are other more subtle reasons that we do not fully understand as a Government research agency. The data are intended to provide insight into what the most important barriers are from the perspective of the organizations that must purchase, use, approve, and manufacture these safety technologies.
NIOSH has an understanding of some of these barriers, however NIOSH is not an end user of these products. Thus the goal of the study is to provide a complete perspective of the barriers from the point of view of the mine operators and technology innovators, in order to improve the efficacy of the contract and grant awards that NIOSH administers under the authority of the MINER Act.
The Federal Mine Safety & Health Act of 1977, Section 501 authorizes the collection of this data. A CDC contractor will collect the required data.
NIOSH will identify 200 stakeholder organizations for structured interviews. Stakeholder organizations include those parties involved in the development, supply, use, and regulation of safety and health protection technologies relevant to underground coal mining. Because there is no nationally representative database of these stakeholder organizations, NIOSH will use web searches of supplier and mining company Web sites, online mining publications, trade association member directories, federal and state regulator Web sites, and university mining research and development programs to compile a list of 200 organizations. Representatives of NIOSH Office of Mining Safety and Health Research will also augment the search with their input.
Of the 200 stakeholder organizations, we expect to elicit participation from 100 and conduct 150 interviews (up to 2 interviews per organization).
A pre-call to each organization is expected to require 15 minutes to complete and the structured interview is expected to require 60 minutes to complete; including the time it may take respondents to look-up and retrieve needed information.
In addition, the workshop will be held in-person and last for nine hours. An average of six hours of travel is estimated for participants in the workshop. The estimated annualized burden hours for the respondents' time to participate in this information collection is 650 hours.
Centers for Medicare & Medicaid Services, HHS.
Notice.
The Centers for Medicare & Medicaid Services (CMS) is announcing an opportunity for the public to comment on CMS' intention to collect information from the public. Under the Paperwork Reduction Act of 1995 (PRA), federal agencies are required to publish notice in the
Comments on the collection(s) of information must be received by the OMB desk officer by February 16, 2017.
When commenting on the proposed information collections, please reference the document identifier or OMB control number. To be assured consideration, comments and recommendations must be received by the OMB desk officer via one of the following transmissions: OMB, Office of Information and Regulatory Affairs, Attention: CMS Desk Officer, Fax Number: (202) 395-5806
To obtain copies of a supporting statement and any related forms for the proposed collection(s) summarized in this notice, you may make your request using one of following:
1. Access CMS' Web site address at
2. Email your request, including your address, phone number, OMB number, and CMS document identifier, to
3. Call the Reports Clearance Office at (410) 786-1326.
Reports Clearance Office at (410) 786-1326.
Under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3520), federal agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. The term “collection of information” is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) requires federal agencies to publish a 30-day notice in the
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Centers for Medicare & Medicaid Services, HHS.
Notice.
The Centers for Medicare & Medicaid Services (CMS) is announcing an opportunity for the public to comment on CMS' intention to collect information from the public. Under the Paperwork Reduction Act of 1995 (the PRA), federal agencies are required to publish notice in the
Comments must be received by March 20, 2017.
When commenting, please reference the document identifier or OMB control number. To be assured consideration, comments and recommendations must be submitted in any one of the following ways:
1.
2.
To obtain copies of a supporting statement and any related forms for the proposed collection(s) summarized in this notice, you may make your request using one of following:
1. Access CMS' Web site address at
2. Email your request, including your address, phone number, OMB number, and CMS document identifier, to
3. Call the Reports Clearance Office at (410) 786-1326.
Reports Clearance Office at (410) 786-1326.
This notice sets out a summary of the use and burden associated with the following information collections. More detailed information can be found in each collection's supporting statement and associated materials (see
Under the PRA (44 U.S.C. 3501-3520), federal agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. The term “collection of information” is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes agency requests or requirements that members of the public submit reports, keep
1.
Administration for Community Living, HHS.
Notice.
The Administration on Intellectual and Developmental Disabilities (AIDD), Administration for Community Living (ACL) is announcing an opportunity for the public to comment on the proposed collection of information by the agency. Under the Paperwork Reduction Act of 1995 (PRA), Federal agencies are required to publish a notice in the
Submit written comments on the collection of information by March 20, 2017.
Submit written comments on the collection of information by email to
Wilma Roberts, Administration for Community Living, Administration on Intellectual and Developmental
Under the PRA (44 U.S.C. 3501-3520), Federal agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. “Collection of information” is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) requires Federal agencies to provide a 60-day notice in the
The proposed Protection and or Traumatic Brain Injury (PATBI) Program Performance Report (PPR) form can be found on the AIDD Web site at:
Interested persons are invited to send comments regarding our burden estimates or any other aspect of this collection of information, including any of the following subjects: (1) The necessity and utility of the proposed information collection for the proper performance of the agency's functions; (2) the accuracy of the estimated burden; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) the use of automated collection techniques or other forms of information technology to minimize the information collection burden.
ACL estimates the burden hours for this collection of information as follows:
Office of Program Support, Administration on Intellectual and Developmental Disabilities, Administration on Disability, Administration on Community Living, HHS.
Notice.
The Administration on Disability is announcing that the proposed collection of information listed above has been submitted to the Office of Management and Budget (OMB) for review and clearance as required under the Paperwork Reduction Act of 1995.
Submit written comments on the collection of information by February 16, 2017.
Submit written comments on the collection of information by fax 202.395.5806 or by email to
Clare Huerta, Administration on Community Living, Administration on Intellectual and Developmental Disabilities, Office of Program Support, 330 C Street SW., DC, Washington, DC 20201, by email:
In compliance with section 44 U.S.C. 3507, ACL has submitted the following proposed collection of information to OMB for review and clearance.
This notice seeks to collect comments on revisions to two existing data collections. The first is the Annual Protection and Advocacy Systems Program Performance Report (0985-0027). State Protection and Advocacy (P&A) Systems in each State and Territory provide individual legal advocacy, systemic advocacy, monitoring and investigations to protect and advance the rights of people with developmental disabilities, using funding administered by the Administration on Intellectual and Developmental Disabilities, Administration on Disability, Administration on Community Living, HHS. The Developmental Disabilities and Bill of Rights Act (the Act), 42 U.S.C. 15044 requires each P&A to annually prepare a Program Performance Report (PPR) that describes the activities and accomplishments of the system during the preceding fiscal year.
The Act also requires P&As to submit a Statement of Goals and Priorities (SGP) (0985-0034) for each coming fiscal year. P&As are required to annually report on “the activities, accomplishments, and expenditures of the system during the preceding fiscal year, including a description of the system's goals, the extent to which the goals were achieved, barriers to their achievement, the process used to obtain public input, the nature of such input, and how such input was used.”
To meet it statutory reporting requirements, P&As have used separate forms for submitting the annual PPR (0985-0027) and the SGP (0985-0034). The Department is proposing that the
The annual PPR and SGP are reviewed by federal staff for compliance and outcomes. Information in the PPRs and SGPs is analyzed to create a national profile of programmatic compliance, outcomes, and goals and priorities for P&A Systems for tracking accomplishments against goals and to formulate areas of technical assistance related to compliance with Federal requirements and program performance. Information collected in the unified report will inform AIDD of trends in P&A advocacy, collaboration with other federally-funded entities, and identify best practices for efficient use of federal funds.
A notice was published in the
In compliance with the requirements of Section 506(c)(2)(A) of the Paperwork Reduction Act of 1995, the Administration on Community Living is soliciting public comment on the burden related to the information collection described above.
Food and Drug Administration, HHS.
Notice of availability.
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled “Comparative Analyses and Related Comparative Use Human Factors Studies for a Drug-Device Combination Product Submitted in an ANDA.” This draft guidance is intended to assist potential applicants who plan to develop and submit an abbreviated new drug application (ANDA) to seek approval of a generic combination product that includes both a drug constituent part and a delivery device constituent part.
Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance March 20, 2017.
You may submit comments as follows:
Submit electronic comments in the following way:
•
• If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see “Written/Paper Submissions” and “Instructions”).
Submit written/paper submissions as follows:
•
• For written/paper comments submitted to the Division of Dockets Management, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in “Instructions.”
•
Submit written requests for single copies of the draft guidance to the Division of Drug Information, Center for Drug Evaluation and Research, Food and Drug Administration, 10001 New Hampshire Ave., Hillandale Building, 4th Floor, Silver Spring, MD 20993-0002. Send one self-addressed adhesive label to assist that office in processing your requests. See the
Andrew LeBoeuf, Office of Generic Drugs, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993, 240-402-0503,
FDA is announcing the availability of a draft guidance for industry entitled “Comparative Analyses and Related Comparative Use Human Factors Studies for a Drug-Device Combination Product Submitted in an ANDA.”
The Drug Price Competition and Patent Term Restoration Act of 1984 (Pub. L. 98-417) (the Hatch-Waxman Amendments) created, among other things, section 505(j) of the Federal Food, Drug and Cosmetic Act (the FD&C Act) (21 U.S.C. 355(j)). Under section 505(j) of the FD&C Act, an ANDA applicant can rely on FDA's previous finding that the reference listed drug (RLD) is safe and effective so long as the ANDA applicant demonstrates that the proposed drug product and the RLD are the same with respect to active ingredient(s), dosage form, route of administration, strength, and, with certain exceptions, labeling. An ANDA must also include sufficient information to demonstrate that the proposed product is bioequivalent to the RLD, and that the ANDA meets the approval requirements relating to chemistry, manufacturing, and controls. An ANDA generally is not required to be the same as the listed drug it references in certain respects. For example, a generic drug generally can differ from its RLD in certain respects with regard to the device or with respect to inactive ingredients.
Drug products that meet the approval requirements under section 505(j) of the FD&C Act are generally considered by FDA to be therapeutically equivalent to their RLD. Products classified as therapeutically equivalent can be substituted with the full expectation that the generic product will produce the same clinical effect and safety profile as the RLD under the conditions specified in the labeling.
These general principles apply to products submitted in ANDAs, including drug-device combination products. A generic drug-device combination product classified as therapeutically equivalent to the RLD can be expected to produce the same clinical effect and safety profile as the RLD under the conditions specified in labeling. This does not mean, however, that the proposed generic drug-device combination product and its RLD need to be identical in all respects. FDA recognizes that an identical design may not always be feasible and, in certain instances, differences in the design of the user interface for a generic drug-device combination product as compared to the RLD may exist without precluding approval of the generic combination drug-device product under an ANDA. In some instances in which differences exist, certain additional information and/or data relating to the user-interface of the proposed generic drug-device combination product, such as data from comparative use human factors studies, may be appropriate to support approval of the proposed product in an ANDA. The extent to which differences between the proposed product and the RLD affect the approvability of the proposed ANDA product will be evaluated on a case-by-case basis.
This draft guidance provides general principles, including recommendations on threshold analyses, which are intended to assist potential applicants in the identification and the assessment of differences in the design of the user interface of a proposed generic drug-device combination product when compared to the user interface for its RLD.
This draft guidance also provides recommendations on the design and conduct of comparative use human factors studies that may help applicants determine whether design differences identified between the proposed generic drug-device combination product and its RLD would preclude approval as an ANDA under the FD&C Act.
This draft guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The draft guidance, when finalized, will represent the current thinking of FDA on “Comparative Analyses and Related Comparative Use Human Factors Studies for a Drug-Device Combination Product Submitted in an ANDA.” It does not establish any rights for any
Persons with access to the Internet may obtain the draft guidance at either
Food and Drug Administration, HHS.
Notice of availability.
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled “Compliance Policy for Required Warning Statements on Small-Packaged Cigars.” The draft guidance, when finalized, is intended to assist any person who manufacturers, packages, sells, offers to sell, distributes, or imports cigars in small packages, in complying with the warning statement requirements in FDA's regulations deeming all other products that meet the statutory definition of a tobacco product to be subject to Chapter IX of the Federal Food, Drug, and Cosmetic Act (the FD&C Act). The draft guidance describes FDA's compliance policy for cigars in packaging that is too small or otherwise unable to accommodate a label with sufficient space to bear the required warning statements. The draft guidance explains that FDA does not intend to take enforcement action with respect to cigars that do not comply with the size and placement requirements in the regulation when the information and specifications required under the regulation appear on the carton or other outer container or wrapper that could accommodate the required warning statements, or on a tag otherwise firmly and permanently affixed to the cigar package.
Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance by February 16, 2017.
You may submit comments as follows:
Submit electronic comments in the following way:
•
• If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see “Written/Paper Submissions” and “Instructions”).
•
• For written/paper comments submitted to the Division of Dockets Management, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in “instructions.”
•
Submit written requests for single copies of this guidance to the Center for Tobacco Products, Food and Drug Administration, Document Control Center, Bldg. 71, Rm. G335, 10903 New Hampshire Ave., Silver Spring, MD 20993-0002. Send one self-addressed adhesive label to assist that office in processing your request or include a fax number to which the guidance document may be sent. See the
Deirdre Jurand, Center for Tobacco
FDA is announcing the availability of a draft guidance for industry entitled “Compliance Policy for Required Warning Statements on Small-Packaged Cigars.”
On June 22, 2009, the President signed the Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act) (Pub. L. 111-31) into law. The Tobacco Control Act granted FDA the authority to regulate the manufacture, marketing, and distribution of cigarettes, cigarette tobacco, roll-your-own tobacco, and smokeless tobacco products to protect the public health and to reduce tobacco use by minors.
The Tobacco Control Act also gave FDA the authority to issue a regulation deeming all other products that meet the statutory definition of a tobacco product to be subject to Chapter IX of the FD&C Act (section 901(b) of the FD&C Act). On May 10, 2016, FDA issued that rule, extending FDA's tobacco product authority to cigars, among other products (81 FR 28974). Among the requirements that now apply to cigars are health warning statements prescribed under section 906(d) of the FD&C Act, which permits restrictions on the sale and distribution of tobacco products that are “appropriate for the protection of the public health.” The rule specifies the health warning statements that must be displayed on cigar packaging and where those statements must be placed, among other requirements.
The draft guidance discusses FDA's compliance policy for cigars with packaging too small or otherwise unable to accommodate the warning statements and specifications required under the regulation.
FDA is issuing this draft guidance consistent with FDA's good guidance practices regulation (21 CFR 10.115). The draft guidance, when finalized, will represent the current thinking of FDA on its compliance policy for cigars in small packaging. It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations.
This draft guidance also refers to previously approved collections of information found in FDA regulations. The collections of information in 21 CFR part 1143 have been approved under 0910-0768.
Persons with access to the Internet may obtain an electronic version of the guidance at either
Food and Drug Administration, HHS.
Notice of availability.
The Food and Drug Administration (FDA or we) is announcing the availability of a draft guidance for industry entitled “Interpretation of and Compliance Policy for Certain Label Requirement; Applicability of Certain Federal Food, Drug, and Cosmetic Act Requirements to Vape Shops.” This draft guidance provides FDA's interpretation of, and a compliance policy for, the requirement that the label of tobacco products contain an accurate statement of the percentage of foreign and domestic grown tobacco under the Federal Food, Drug, and Cosmetic Act (the FD&C Act). This draft guidance document is also intended to assist retailers who sell newly deemed products by explaining whether engaging in certain activities subjects such establishments to additional requirements of the FD&C Act and the limited circumstances under which FDA does not intend to enforce compliance.
Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers your comment of this draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance by February 16, 2017.
You may submit comments as follows:
Submit electronic comments in the following way:
•
• If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see “Written/Paper Submissions” and “Instructions”).
Submit written/paper submissions as follows:
•
• For written/paper comments submitted to the Division of Dockets Management, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in “Instructions.”
• Confidential Submissions—To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states “THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.” The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on
Submit written requests for single copies of the draft guidance to the Center for Tobacco Products, Food and Drug Administration, Document Control Center, Bldg. 71, Rm. G335, 10903 New Hampshire Ave., Silver Spring, MD 20993-0002. Send one self-addressed adhesive label to assist that office in processing your request or include a fax number to which the guidance document may be sent. See the
Katherine Collins, Center for Tobacco Products, Food and Drug Administration, Document Control Center, 10903 New Hampshire Ave., Bldg. 71, Rm. G335, Silver Spring, MD 20993-0002, 1-877-287-1373, email:
We are announcing the availability of a draft guidance for industry entitled “Interpretation of and Compliance Policy for Certain Label Requirement; Applicability of Certain Federal Food, Drug, and Cosmetic Act Requirements to Vape Shops.”
This draft guidance document, when finalized, will provide FDA's interpretation of, and a compliance policy for, the label requirement under section 903(a)(2)(C) of the FD&C Act (21 U.S.C. 387c(a)(2)(C)). This draft guidance document, when finalized, is also intended to assist retailers who sell newly deemed products by explaining whether engaging in certain activities subjects such establishments to additional requirements of the FD&C Act and the limited circumstances under which FDA does not intend to enforce compliance.
The Family Smoking Prevention and Tobacco Control Act (Pub. L. 111-31) (Tobacco Control Act), enacted on June 22, 2009, amends section 904 of the FD&C Act (21 U.S.C. 387d) and provides FDA with the authority to regulate the manufacture, marketing, and distribution of tobacco products to protect the public health generally and to reduce tobacco use by minors.
Cigarettes, cigarette tobacco, roll-your-own tobacco, and smokeless tobacco were immediately covered by FDA's tobacco product authorities in chapter IX of the FD&C Act, when the Tobacco Control Act went into effect. As for other types of tobacco products, section 901(b) of the FD&C Act (21 U.S.C. 387a(b)) grants FDA authority to deem those products subject to chapter IX of the FD&C Act. Under that authority, FDA issued a rule deeming all other products that meet the statutory definition of “tobacco product,” set forth in section 201(rr) of the FD&C Act (21 U.S.C. 321(rr)), except for accessories of those products, as subject to chapter IX of the FD&C Act (81 FR 28974). FDA published the final rule on May 10, 2016, and it became effective on August 8, 2016.
Section 903(a)(2)(C) of the FD&C Act provides that a tobacco product in package form is misbranded unless its label contains “an accurate statement of the percentage of tobacco used in the product that is domestically grown tobacco and the percentage that is foreign grown tobacco.” The draft guidance provides FDA's interpretation of, and a compliance policy for, this label requirement.
Retail establishments, such as vape shops, which engage in certain activities may also be subject to certain requirements of the FD&C Act that apply to tobacco product manufacturers and to establishments that engage in the manufacture, preparation, compounding, or processing of tobacco product. These activities may also include modifying a product so that it is a new tobacco product requiring compliance with the premarket authorization requirements. This draft guidance explains which activities subject vape shops to these FD&C Act requirements and the limited circumstances under which FDA does not intend to enforce compliance.
FDA is issuing this draft guidance consistent with FDA's good guidance practices regulation (21 CFR 10.115). The draft guidance, when finalized, will represent the current thinking of FDA. It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations.
Persons with access to the Internet may obtain an electronic version of the draft guidance at either
Food and Drug Administration, HHS.
Notice of availability.
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled
Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance by March 20, 2017.
You may submit comments as follows:
Submit electronic comments in the following way:
•
• If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see “Written/Paper Submissions” and “Instructions”).
Submit written/paper submissions as follows:
•
• For written/paper comments submitted to the Division of Dockets Management, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in “Instructions.”
• Confidential Submissions—To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states “THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.” The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on
Submit written requests for single copies of the draft guidance to the Division of Drug Information, Center for Drug Evaluation and Research, Food and Drug Administration, 10001 New Hampshire Ave., Hillandale Building, 4th Floor, Silver Spring, MD 20993-0002. Send one self-addressed adhesive label to assist that office in processing your requests. See the
Gail Schmerfeld, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993-0002, 301-796-9291,
FDA is announcing the availability of a draft guidance for industry entitled “Referencing Approved Drug Products in ANDA Submissions.” To obtain approval of an ANDA submitted under section 505(j) of the FD&C Act (21 U.S.C. 355(j)), an ANDA applicant generally must show, among other things, that the proposed generic drug has the same active ingredient(s), conditions of use, route of administration, dosage form, strength, and, with certain permissible differences, labeling as the specific listed drug referred to in the ANDA,
This guidance provides information to potential applicants on how to identify a “reference listed drug,” “reference standard,” and the “basis of submission” in ANDA submissions. A variety of factors has led to confusion among stakeholders on what these terms mean and how an ANDA applicant should use them. These factors include the discontinued marketing of many approved drug products and FDA's identification of reference standards with the RLD symbol (“+”) in the printed version, and under the “RLD” column in the electronic version, of FDA's “Approved Drug Products with Therapeutic Equivalence Evaluations” (the “Orange Book”). This guidance is intended to address this confusion by explaining what these terms mean and clarifying the differences among them. This guidance provides
This draft guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The draft guidance, when finalized, will represent the current thinking of FDA on Referencing Approved Drug Products in ANDA Submissions. It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations.
Persons with access to the Internet may obtain the draft guidance at either
Food and Drug Administration, HHS.
Notice of public hearing; request for comments.
The Food and Drug Administration (FDA or we) is announcing a public hearing regarding FDA initiatives for enhancing the safety of foods (for humans and animals) imported into the United States. The hearing will focus on partnerships to improve safety capabilities through capacity building; partnerships that incorporate information from private entities and foreign competent authorities to inform risk-based decisionmaking; partnerships that recognize commodity-specific export programs; and partnerships that recognize the robustness of a nation's entire food safety system. In addition, we are seeking information from a variety of viewpoints, including from competent authorities in other countries and from private entities, to help inform FDA regarding risk-based decisionmaking, commodity-specific export control programs in other countries, and systems recognition.
See “How to Participate in the Hearing” in the
You may submit comments as follows:
Submit electronic comments in the following way:
•
• If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see “Written/Paper Submissions” and “Instructions”).
Submit written/paper submissions as follows:
•
• For written/paper comments submitted to the Division of Dockets Management, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in “Instructions.”
• Confidential Submissions—To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states “THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.” We will review this copy, including the claimed confidential information, in our consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on
Wade Woolfolk, Food and Drug Administration, Center for Food Safety and Applied Nutrition (HFS-550), 5001
On March 30-31, 2011, we held a public hearing to discuss our use of international comparability assessments as a mechanism to help enhance the safety of imported foods (see “Ensuring the Safety of Imported Foods and Animal Feed: Comparability of Food Safety Systems and Import Practices of Foreign Countries; Public Hearing; Request for Comments” (76 FR 13638, March 14, 2011; available at
FSMA has enabled us to better protect public health through new authorities to help ensure that imported foods meet the same safety standards as foods produced in the United States.
In implementing FSMA, we recognize the importance of strengthening the existing collaborations among food safety regulators (U.S. Federal, State, local, territorial, tribal, and foreign) to achieve our public health goals. We continue to engage in a variety of partnerships that, collectively, are intended to enhance the safety of foods imported into the United States.
At the public hearing that is the subject of this notice, we will provide an update on our food safety capacity building efforts, as well as additional updates and information on the approach we will use to help ensure the safety of imported foods. In addition, the public hearing will provide an opportunity for FDA to obtain testimony from diverse stakeholder groups as we seek to develop, expand, or refine key partnership activities.
We seek input from a variety of perspectives on the following topics:
• How to expand performance measurement for FDA's capacity building activities to ensure that we collaborate effectively with other nations, multilateral organizations, donor organizations, and industry.
• How to operationalize the concept of “same level of public health protection” that is part of the rule on Foreign Supplier Verification Programs (FSVP) (80 FR 74226, November 27, 2015) and what types of partnerships facilitate application of this concept. (The FSVP regulation requires importers to implement FSVPs to provide adequate assurances that the importer's foreign suppliers produce food in compliance with processes and procedures, including risk-based preventive controls, that provide the same level of public health protection as those required under section 418 (concerning hazard analysis and preventive controls) or 419 (concerning produce safety) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act), as appropriate, and in compliance with sections 402 (concerning adulteration) and 403(w) (concerning misbranding regarding allergen labeling) of the FD&C Act.)
• Whether and how we should consider private standards in risk-based decisionmaking, including how other competent authorities use information, such as third-party certifications or other assurances, from private entities.
• Whether and how we should expand our systems recognition framework to include consideration of the recognition of commodity-specific export control programs.
The initiatives that will be discussed at the public hearing align with and support FSMA implementation. Day one of the hearing will seek input on partnerships to improve food safety capabilities in other countries, tools to inform FDA's risk based decisionmaking, and methods to assess the effectiveness of our capacity building efforts. We also seek input on whether and how best to incorporate input from private entities and other competent authorities into our risk-based decisionmaking framework. Day two will seek input on partnerships that recognize the robustness of commodity-specific export programs including export certification programs and whether and how we should consider such programs. In addition, we seek input on the implementation of the systems recognition program. Interested parties may submit comments, data, and supporting information on the issues described in part II of this document.
Section 305 of FSMA requires the Secretary of Health and Human Services to develop a comprehensive plan to expand the technical, scientific, and regulatory food safety capacity of foreign governments, and their respective food industries, from which foods are exported to the United States. This authority was delegated to FDA, and we developed an International Food Safety Capacity Building Plan (the Plan). The Plan gives us a strategic framework to expand the technical, scientific, and regulatory capacity of foreign governments and their food industries. We developed the Plan in consultation with many partners, such as officials from other parts of the U.S. government; foreign government officials; non-governmental organizations (NGOs) that represent consumer interests; food industry representatives; and others. We seek input on successful models for continuing capacity building to further implement the plan. At this hearing, we will seek comment on food safety capacity building and development and invite comment, particularly publications and data, on food safety performance monitoring regimes; how donor organizations minimize duplication and support leveraged partnerships; how providers of training programs assure affordable, accessible, and culturally specific information is available to various regions of the world; how development agencies interface with food industry supply chain management programs; and whether we and industry can leverage each other's efforts.
In the
We are interested in identifying successful models that recognize commodity specific food safety control systems (including export certification programs), how they are established, and how they operate.
We seek comment and views on the best practices, strengths and weaknesses of commodity export programs or export certification systems; how commodity recognition programs factor into risk-based inspectional systems; and once adopted, how the programs are monitored over time.
FDA's systems recognition assessment process established in 2011 has progressed from a pilot to a robust program that has resulted in signed arrangements with New Zealand's Ministry for Primary Industries (2012) and Canada's Canadian Food Inspection Agency (CFIA) and the Department of Health Canada (Health Canada) (2016). We seek comment on what indicators we should consider to determine whether the program meets expected outcomes and best practices on how to identify robust food safety systems.
The Commissioner of Food and Drugs (the Commissioner) is announcing that the public hearing will be held in accordance with part 15 (21 CFR part 15). The hearing will be conducted by a presiding officer(s), accompanied by FDA senior management and staff from the relevant centers/offices (FDA panelists/experts).
Under § 15.30(f), the hearing is informal, and the rules of evidence do not apply. We encourage interested parties to submit comments to the docket. We also have invited certain members of the public to participate as guest presenters. Only the presiding officer(s) and FDA panelists/experts may question any person during or at the conclusion of each presentation by the FDA and guest presenters (§ 15.30(e)). At their discretion, the presiding officer(s) may permit questions to be submitted from the audience for response by FDA or other persons attending the hearing (§ 15.30(e)). Finally, time permitting, stakeholders may be allowed to provide testimony at the hearing. Time will be limited to 2 minutes and requests to make an oral presentation must be written and received by February 8, 2017. Please include the details of your presentation when making your request. All testimony will be entered into the docket. Public hearings under part 15 are subject to FDA's policy and procedures for electronic media coverage of FDA's public administrative proceedings (21 CFR part 10, subpart C) (§ 10.203(a)). Under § 10.205, representatives of the electronic media may be permitted, subject to certain limitations, to videotape, film, or otherwise record FDA's public administrative proceedings, including presentations by participants. The hearing will be transcribed as stipulated in § 15.30(b) (see part IV of this document). To the extent that the conditions for the hearing as described in this document conflict with any provisions set out in part 15, this notice acts as a waiver of those provisions as specified in § 15.30(h).
Comments may also be submitted after the hearing. The docket will remain open for such comments until May 16, 2017.
Advance registration by submission of a notice of participation is necessary to ensure participation and will be accepted on a first-come, first-served basis.
Notices of participation may be submitted electronically (see table 1 of this document); FDA encourages the use of electronic means of advance registration. Notices of participation may also be submitted orally or by mail, fax, or email (see
Table 1 of this document provides information on participation in the public meetings.
Please be advised that as soon as a transcript is available, it will be accessible at
Health Resources and Services Administration (HRSA), Department of Health and Human Services.
Notice.
In compliance with the requirement for opportunity for public comment on proposed data collection projects of the Paperwork Reduction Act of 1995, HRSA has submitted an Information Collection Request (ICR) to the Office of Management and Budget (OMB) for review and approval. Comments submitted during the first public review of this ICR will be provided to OMB. OMB will accept further comments from the public during the review and approval period.
Comments on this ICR should be received no later than February 16, 2017.
Submit your comments, including the Information Collection Request Title, to the desk officer for HRSA, either by email to
To request a copy of the clearance requests submitted to OMB for review, email the HRSA Information Collection Clearance Officer at
Need and Proposed Use of the Information: The Hospital Campaign's Activity Scorecard is a key component of this effort. It provides a menu of over 40 ideas for outreach activities. The Activity Scorecard also provides incentive for hospitals to participate by laying the foundation for recognition. Each activity on the programmable PDF is assigned a particular number of points based on the activity's potential for generating registrations. Recognition is awarded to hospitals that have annual points which qualify them for one of the following recognition levels: bronze, silver, gold, and platinum.
Hospitals can complete the Activity Scorecard and submit it annually via email or fax to HRSA or to their local OPO or Donate Life America (DLA) affiliate to be considered for recognition. This is a voluntary activity and hospitals may participate in the campaign without using or submitting a completed Activity Scorecard. However, most hospitals enrolled in the campaign (currently 2,038) have submitted a completed Activity Scorecard to become eligible for recognition.
Hospitals that achieve specific outlined levels are recognized annually
Revisions for this submission of the information collection request include two new opportunities for hospitals to earn points: a point is awarded for each donor registration a hospital motivates and points are awarded for reaching the hospital's donor registration goal. In addition, HRSA is making various formatting changes and the point values for two activities have been increased.
Likely Respondents: Hospital representatives, most often the organ donation champions identified by the OPOs, can download the form from
Burden Statement: Burden in this context means the time expended by persons to generate, maintain, retain, disclose or provide the information requested. This includes the time needed to review instructions; to develop, acquire, install, and utilize technology and systems for the purpose of collecting, validating and verifying information, processing and maintaining information, and disclosing and providing information; to train personnel and be able to respond to a collection of information; to search data sources; and to complete and review the collection of information; and to transmit or otherwise disclose the information. The total annual burden hours estimated for this ICR are summarized in the table below.
U.S. Customs and Border Protection, Department of Homeland Security.
Delay of effective date.
On August 30, 2016, U.S. Customs and Border Protection (CBP) published a notice in the
Questions related to this notice may be emailed to
On August 30, 2016, U.S. Customs and Border Protection (CBP) published a notice in the
The effective date for the all that was announced in the August 30, 2016
U.S. Customs and Border Protection, Department of Homeland Security.
Delay of effective date.
This notice announces that the effective date for the modifications to the National Customs Automation Program (NCAP) tests regarding Reconciliation, Post-Summary Corrections, and Periodic Monthly Statements is delayed until further notice. On December 12, 2016, U.S. Customs and Border Protection (CBP) published a notice in the
The effective date for the modifications to the reconciliation, PSC, and PMS NCAP tests is delayed until further notice.
Comments concerning the reconciliation test program may be submitted any time during the test via email, with a subject line identifier reading, “Comment on Reconciliation test”, to
Comments concerning the PSC and PMS test programs may be submitted via email to Monica Crockett at
On December 12, 2016, U.S. Customs and Border Protection (CBP) published a notice entitled “Modification of the National Customs Automation Program Test Regarding Reconciliation and Transition of the Test from the Automated Commercial System to the Automated Commercial Environment” in the
CBP has assessed stakeholder readiness for the mandatory transition of post-release capabilities in ACE, including the modifications to the reconciliation test and the transition of reconciliation filings from ACS to ACE. This notice announces that the effective date for the modifications to the reconciliation test, and for mandatory filing of reconciliation entries in ACE has been delayed until further notice.
On December 12, 2016, U.S. Customs and Border Protection (CBP) published a notice in the
Subsequently, CBP decided not to implement two of the changes announced in the December 12, 2016 notice. In a notice published in the
National Protection and Programs Directorate, DHS.
Committee management; notice of an Open Federal Advisory Committee meeting.
The National Infrastructure Advisory Council (NIAC) will meet Thursday, February 16, 2017, at 1331 F Street NW., Suite 1000, Washington, DC 20004. This meeting will be open to the public.
The NIAC will meet on February 16, 2017. The meeting will be held from 1:30 p.m.-4:30 p.m. EST. The meeting may close early if the committee has completed its business. For additional information, please consult the NIAC Web site,
1331 F Street NW., Suite 1000, Washington, DC 20004. Members of the public will register at the registration table prior to entering the meeting room. For information on facilities or services for individuals with disabilities, or to request special assistance at the meeting, contact the person listed under
To facilitate public participation, we are inviting public comment on the issues to be considered by the Council as listed in the “Summary” section below. Comments must be submitted in writing no later than 12:00 p.m. on February 13, 2017, in order to be considered by the Council in its meeting. The comments must be identified by “DHS-2016-0089,” and may be submitted by any
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Members of the public will have an opportunity to provide oral comments on the topics on the meeting agenda below, and on any previous studies issued by the NIAC. We request that comments be limited to the issues and studies listed in the meeting agenda and previous NIAC studies. All previous NIAC studies can be located at
Ginger Norris, Department of Homeland Security, National Protection and Programs Directorate, Office of Infrastructure Protection, NIAC, Designated Federal Officer, 245 Murray Lane SW., Mail Stop 0607, Washington, DC 20598-0607, telephone 202-441-5885.
Notice of this meeting is given under the Federal Advisory Committee Act, 5 U.S.C. appendix. The NIAC shall provide the President, through the Secretary of Homeland Security, with advice on the security and resilience of the Nation's critical infrastructure sectors. The NIAC will meet to discuss issues relevant to critical infrastructure security and resilience, as directed by the President.
The meeting will commence at 1:00 p.m. EST. At this meeting, the Council will discuss its newest tasking and receive briefings. All presentations will be posted prior to the meeting on the Council's public Web page—
Office of the Secretary, Department of Homeland Security.
Notice.
This notice concerns the authority of the Department of Homeland Security (DHS or the Department) to place certain designated categories of aliens in expedited removal proceedings. On November 13, 2002, the former Immigration and Naturalization Service (INS) of the Department of Justice issued a notice designating certain aliens who arrive by sea, either by boat or other means, as eligible for placement in expedited removal proceedings, with an exception for Cuban citizens or nationals (hereinafter “Cuban nationals”). On August 11, 2004, DHS issued a notice designating certain aliens in the United States as eligible for placement in expedited removal proceedings, also with an exception for Cuban nationals. In light of recent changes in the relationship between the United States and Cuba, the Department has determined that the exceptions for Cuban nationals, contained in the designations of November 13, 2002 and August 11, 2004, are no longer warranted and are thus hereby eliminated. The rest of the November 13, 2002 and August 11, 2004 designations, including any implementing policies, are unaffected by this notice and remain unchanged.
This notice is effective on January 13, 2017. Interested persons are invited to submit written comments on this notice on or before March 20, 2017.
You may submit comments, identified by DHS Docket Number DHS-2017-0004, by any one of the following methods:
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Please submit your comments by only one method. Comments received by means other than those listed above or received after the comment period has closed will not be reviewed. All comments received will be posted without change on
Postal delivery in Washington, DC, may be delayed due to security concerns. Therefore, DHS encourages the public to submit comments through the
Amanda Baran, Principal Director for Immigration Policy, 202-282-8805,
Section 302 of the Illegal Immigration Reform and Immigrant Responsibility Act of 1996 (IIRIRA), Public Law 104-208, Div. C, 110 Stat. 3009-546, amended section 235(b) of the Immigration and Nationality Act (“Act”), 8 U.S.C. 1225(b), to authorize the Attorney General (now the Secretary of Homeland Security as designated under the Homeland Security Act of 2002) to remove, without a hearing before an immigration judge, aliens arriving in the United States and certain other applicants for admission who are inadmissible under sections 212(a)(6)(C) or 212(a)(7) of the Act, 8 U.S.C. 1182(a)(6)(C) and 1182(a)(7), for lack of valid documents necessary for admission or entry or for procuring or seeking to procure a visa, other immigration-related documentation, admission to the United States, or other immigration benefit by fraud or willful misrepresentation of a material fact.
Expedited removal proceedings under section 235(b) of the Act, 8 U.S.C. 1225(b), may be applied to two categories of aliens. First, expedited removal proceedings may be used for aliens who are “arriving in the United States.” Section 235(b)(1)(A)(i) of the Act, 8 U.S.C. 1225(b)(1)(A)(i). Second, the Secretary, in his or her sole and unreviewable discretion, may designate certain other aliens to whom the expedited removal provisions may be applied. Section 235(b)(1)(A)(iii) of the Act, 8 U.S.C. 1225(b)(1)(A)(iii);
On November 13, 2002, the former INS issued a
The November 13, 2002 notice, however, contained an exception for Cuban nationals who are otherwise described in the designated class, stating that expedited removal proceedings would not be initiated against such Cuban nationals who arrive by sea.
On August 11, 2004, DHS issued a similar
Like the November 13, 2002 notice, the August 11, 2004 notice contained an exception for Cuban nationals who are otherwise described in the designated class and stated that expedited removal proceedings would not be initiated against such nationals encountered in the United States.
Since those notices were issued, significant changes in the relationship between the United States and Cuba have occurred. In December 2014, President Obama announced a historic opening between the United States and Cuba, as well as an approach for reestablishing diplomatic relations and adjusting regulations to facilitate greater travel, commerce, people-to-people ties, and the free flow of information to, from, and within Cuba. On July 20, 2015, the United States and Cuba formally reestablished full diplomatic relations and opened embassies in each other's countries. In the time following the reestablishment of full diplomatic relations, the United States and Cuba have taken concrete steps towards enhancing security, building bridges between our peoples, and promoting economic prosperity for citizens of both countries. And recent migration discussions have yielded important changes that will dramatically affect travel and migration between our two countries. Among other things, Cuba has agreed to accept and facilitate the repatriation of its nationals who are ordered removed from the United States. This arrangement and other changes remain the focus of ongoing diplomatic discussions between the two countries.
DHS also has recently seen a significant increase in attempts by Cuban nationals to illegally enter the United States. Many of those Cuban nationals have taken a dangerous journey through Central America and Mexico; others have taken to the high seas in the dangerous attempt to cross the Straits of Florida. DHS believes this increase in attempted migration has been driven in part by the perception that there is a limited window before the United States will eliminate favorable immigration policies for Cuban nationals.
The application of the expedited removal authorities to Cuban nationals must reflect these new realities. First, the Department notes that the statutory provision categorically barring the use of expedited removal for certain aliens who arrive by aircraft at a U.S. port of entry no longer applies to Cuban nationals, as the United States and Cuba have reestablished full diplomatic relations.
Accordingly, this notice eliminates the categorical exceptions for Cuban nationals, with respect to both the November 13, 2002 and August 11, 2004 notices, on a prospective basis, beginning on January 13, 2017,
As it did for the November 13, 2002 and August 11, 2004 notices, and consistent with implementing regulations at 8 CFR 235.3(b)(1)(ii), the Department has determined that good cause exists to exempt this notice from the notice-and-comment and 30-day delayed effective date requirements under the Administrative Procedure Act (APA).
Moreover, as with the August 11, 2004 notice, the designation in this notice is necessary to remove quickly from the United States aliens who are encountered shortly after illegally entering across U.S. land borders. The ability to detain such aliens while admissibility and identity are determined and protection claims are adjudicated, as well as to quickly remove those without protection claims or claims to lawful status, is a necessity for national security and public safety.
DHS has determined that pre-promulgation notice and comment would undermine these interests, while endangering human life and having a potential destabilizing effect in the region. Among other things, such opportunity for notice and comment could result in a surge in migration of Cuban nationals seeking to travel to and enter the United States prior to the effectuation of the changes announced in this notice. Such a surge would threaten national security and public safety by diverting valuable Government resources from counterterrorism and homeland security responsibilities.
In addition, the change implemented by this notice is part of a major foreign policy initiative announced by the President, and is central to ongoing
Finally, and for the same reasons described above, DHS finds that delay caused by publication would adversely affect the interests of the United States and the effective enforcement of the immigration laws, and therefore invokes 8 CFR 235.3(b)(1)(ii) to make this designation effective immediately upon placement on public inspection.
Although advance notice and comment procedures are not in the interests of the United States with respect to this notice, DHS is interested in receiving comments from the public on the elimination of the categorical exception for Cuban nationals. DHS believes that by maintaining a dialogue with interested parties, DHS may be better positioned to ensure that the program is even more effective in combating and deterring illegal entry, while at the same time protecting the rights of the individuals affected.
Pursuant to section 235(b)(1)(A)(iii) of the Immigration and Nationality Act (8 U.S.C. 1225(b)(1)(A)(iii)) and 8 CFR 235.3(b)(1)(ii), I order as follows:
(1) With respect to the above-referenced Designation of November 13, 2002, 67 FR 68924, I hereby rescind the provision at numbered paragraph (5), specifying that “[e]xpedited removal proceedings will not be initiated against Cuban citizens or nationals who arrive by sea,” and other language of the Designation referencing or relating to that exception for Cuban citizens or nationals.
(2) With respect to the above-referenced Designation of August 11, 2004, 69 FR 48877, I hereby rescind the provision at numbered paragraph (6), specifying that “[t]he expedited removal proceedings contemplated by this notice will not be initiated against Cuban citizens or nationals,” and other language of the Designation referencing or relating to that exception for Cuban citizens or nationals.
U.S. Citizenship and Immigration Services, Department of Homeland Security.
Notice.
The Department of Homeland Security (DHS) announces that the Secretary of Homeland Security (Secretary) is extending the designation of Somalia for Temporary Protected Status (TPS) for a period of 18 months, effective March 18, 2017 through September 17, 2018. This extension allows eligible Somali nationals (and aliens having no nationality who last habitually resided in Somalia) to retain TPS through September 17, 2018, so long as they otherwise continue to meet the eligibility requirements for TPS. The Secretary has determined that an extension is warranted because conditions in Somalia supporting its designation for TPS continue to be met. Through this Notice, DHS also sets forth procedures necessary for nationals of Somalia (or aliens having no nationality who last habitually resided in Somalia) to re-register for TPS and to apply for renewal of their Employment Authorization Documents (EAD) with U.S. Citizenship and Immigration Services (USCIS).
The 18-month extension of the TPS designation of Somalia is effective as of March 18, 2017, and will remain in effect through September 17, 2018. The 60-day re-registration period runs from January 17, 2017 through March 20, 2017. Note: It is important for re-registrants to timely re-register during this 60-day period and not to wait until their EADs expire.
• For further information on TPS, including guidance on the application process and additional information on eligibility, please visit the USCIS TPS Web page at
• You can also contact Guillermo Roman-Riefkohl, TPS Program Manager, Waivers and Temporary Services Branch, Service Center Operations Directorate, U.S. Citizenship and Immigration Services, Department of Homeland Security, 20 Massachusetts Avenue NW., Washington, DC 20529-2060; or by phone at 202-272-1533 (this is not a toll-free number).
The phone number provided here is solely for questions regarding this TPS Notice. It is not for individual case status inquires.
• Applicants seeking information about the status of their individual cases can check Case Status Online, available at the USCIS Web site at
• Further information will also be available at local USCIS offices upon publication of this Notice.
• TPS is a temporary immigration status granted to eligible nationals of a country designated for TPS under the Immigration and Nationality Act (INA), or to eligible aliens without nationality who last habitually resided in the designated country.
• During the TPS designation period, TPS beneficiaries are eligible to remain in the United States, may not be removed, and are authorized to work and obtain EADs, so long as they continue to meet the requirements of TPS.
• TPS beneficiaries may be granted travel authorization as a matter of discretion.
• The granting of TPS does not result in or lead to lawful permanent resident status.
• When the Secretary terminates a country's TPS designation through a separate
On September 16, 1991, the Attorney General designated Somalia for TPS based on extraordinary and temporary conditions.
This extension of Somalia's designation for TPS allows eligible Somali nationals (and aliens having no nationality who last habitually resided in Somalia) who currently hold TPS to retain it through September 17, 2018, so long as they otherwise continue to meet the eligibility requirements for TPS. Current beneficiaries who wish to maintain their TPS should file a re-registration application with USCIS. They may also apply for renewal of their EADs.
Re-registration is limited to persons who have previously registered for TPS under the designation of Somalia and whose applications have been granted. Certain nationals of Somalia (or aliens having no nationality who last habitually resided in Somalia) who have not previously applied for TPS may be eligible to apply under the late initial registration provisions, if they meet: (1) At least one of the late initial filing criteria; and (2) all TPS eligibility criteria (including continuous residence in the United States since May 1, 2012, and continuous physical presence in the United States since September 18, 2012).
For individuals who have already been granted TPS under Somalia's designation, the 60-day re-registration period runs from January 17, 2017 through March 20, 2017. USCIS will issue new EADs with a September 17, 2018 expiration date to eligible Somalia TPS beneficiaries who timely re-register and apply for EADs under this extension. Given the timeframes involved with processing TPS re-registration applications, DHS recognizes that not all re-registrants will receive new EADs before their current EADs expire on March 17, 2017. Accordingly, through this Notice, DHS automatically extends the validity of EADs issued under the TPS designation of Somalia for 6 months, through September 17, 2017, and explains how TPS beneficiaries and their employers may determine which EADs are automatically extended and their impact on the Employment Eligibility Verification (Form I-9) and E-Verify processes.
Section 244(b)(1) of the INA, 8 U.S.C. 1254a(b)(1), authorizes the Secretary, after consultation with appropriate U.S. Government (Government) agencies, to designate a foreign state (or part thereof) for TPS if the Secretary finds that certain country conditions exist.
DHS, in consultation with the Department of State, has conducted a thorough review of conditions in Somalia. Based on this review, the Secretary has determined that an 18-month extension of Somalia's designation for TPS is warranted because the conditions that supported its 2012 redesignation—(1) ongoing armed conflict and (2) extraordinary and temporary conditions that prevent Somali nationals from returning to Somalia in safety—continue to exist. The Secretary has further determined that permitting eligible Somali nationals to remain temporarily in the United States is not contrary to the national interest of the United States.
The security situation in Somalia remains fragile and volatile, with much of Somalia in a state of ongoing armed conflict between government forces, clan militia, African Union troops, and al-Shabaab. Al-Shabaab controls large swaths of territory in southern Somalia and conducts frequent asymmetric attacks on military and civilian targets in government-controlled areas. Additionally, some parts of the country not under al-Shabaab control experience high levels of insecurity due to inter- and intra-clan conflict. Members of minority clans are systematically marginalized, abused, and sometimes killed by members of larger clans. Minority clan members have also been largely displaced from their original territories in Somalia, and members of those clans who return to Somalia may find themselves in displaced persons camps. Individuals living in informal camps for displaced persons have been subjected to serious abuses, including rape, physical attacks, restricted access to humanitarian assistance, and clan-based discrimination.
Somalia continues to experience a complex protracted emergency that is one of the worst humanitarian crises in the world. Approximately 5 million people (over 40 percent of the total population of around 11 million) are in need of humanitarian assistance, and there are an estimated 1.1 million internally displaced persons. Malnutrition rates in Somalia are among the highest in the world, with an estimated one million people experiencing acute food insecurity. The 2015-2016 El Niño phenomenon has intensified extensive flooding and severe drought, with the drought conditions contributing to deteriorating food security in northern areas of the country. Non-permanent water sources, such as dams and streams are drying up, driving up the price of water. Vulnerable households are forced to consume unsafe water because they are unable to pay the high cost.
Approximately 3.2 million people in Somalia lack sufficient access to emergency health care services, and about 1.9 million people are at risk of dying of preventable diseases due to lack of access to primary health care services. The maternal mortality rate in Somalia is among the highest in the world. Due to the drought, health facilities have seen an increase in waterborne communicable diseases, as the only available remaining water sources are shared by humans and livestock. Health facilities have also recorded an increased incidence of diseases associated with a lack of water and poor hygiene, namely skin diseases, respiratory infections, and febrile illnesses.
Based upon DHS's review of conditions in Somalia and after consultation with appropriate Government agencies, the Secretary has determined that:
• The conditions that prompted the May 1, 2012 redesignation of Somalia for TPS continue to be met.
• There continues to be an ongoing armed conflict in Somalia and, due to such conflict, requiring the return of Somali nationals would pose a serious threat to their safety.
• There continue to be extraordinary and temporary conditions in Somalia that prevent Somali nationals from returning to Somalia in safety.
• It is not contrary to the national interest of the United States to permit Somalis (and persons who have no nationality who last habitually resided in Somalia) who meet the eligibility requirements of TPS to remain in the United States temporarily.
• The designation of Somalia for TPS should be extended for an additional 18-month period from March 18, 2017 through September 17, 2018.
By the authority vested in me as Secretary under INA section 244, 8 U.S.C. 1254a, I have determined, after consultation with the appropriate Government agencies, that the conditions supporting the most recent designation of Somalia for Temporary Protected Status (TPS) on May 1, 2012 continue to be met.
If you are a current TPS beneficiary, then you need to file a re-registration application under the extension if you wish to maintain TPS benefits through September 17, 2018. You must use the Application for Temporary Protected Status (Form I-821) to re-register for TPS. The 60-day open re-registration period will run from January 17, 2017 through March 20, 2017.
To register or re-register for TPS based on the designation of Somalia, an applicant must submit each of the following two applications:
1. Application for Temporary Protected Status (Form I-821).
• If you are filing an application for late initial registration, you must pay the fee for the Application for Temporary Protected Status (Form I-821).
• If you are filing an application for re-registration, you do not need to pay the fee for the Application for Temporary Protected Status (Form I-821).
2. Application for Employment Authorization (Form I-765).
• If you are applying for late initial registration and want an EAD, you must pay the fee for the Application for Employment Authorization (Form I-765) only if you are age 14 through 65. No fee for the Application for Employment Authorization (Form I-765) is required if you are under the age of 14 or are 66 and older and applying for late initial registration.
• If you are applying for re-registration, you must pay the fee for the Application for Employment Authorization (Form I-765) only if you want an EAD, regardless of age.
• You do not pay the fee for the Application for Employment Authorization (Form I-765) if you are not requesting an EAD, regardless of whether you are applying for late initial registration or re-registration.
You must submit both completed application forms together. If you are unable to pay for the Application for Employment Authorization (Form I-765) and/or biometric services fee, you may apply for a fee waiver by completing a Request for Fee Waiver (Form I-912) or submit a personal letter requesting a fee waiver, and provide satisfactory supporting documentation. For more information on the application forms and fees for TPS, please visit the USCIS TPS Web page at
Biometrics (such as fingerprints) are required for all applicants 14 years of age or older. Those applicants must submit a biometric services fee. As previously stated, if you are unable to pay for the biometric services fee, you may apply for a fee waiver by completing a Request for Fee Waiver (Form I-912) or by submitting a personal letter requesting a fee waiver, and providing satisfactory supporting documentation. For more information on the biometric services fee, please visit the USCIS Web site at
USCIS urges all re-registering applicants to file as soon as possible within the 60-day re-registration period so that USCIS can process the applications and issue EADs promptly. Filing early will also allow those applicants who may receive denials of their fee waiver requests to have time to re-file their applications before the re-registration deadline. If, however, an applicant receives a denial of his or her fee waiver request and is unable to re-file by the re-registration deadline, the applicant may still re-file his or her application. This situation will be reviewed to determine whether the applicant has established good cause for late re-registration. However, applicants are urged to re-file within 45 days of the date on their USCIS fee waiver denial notice, if at all possible.
Mail your application for TPS to the proper address in Table 1.
If you were granted TPS by an Immigration Judge (IJ) or the Board of Immigration Appeals (BIA), and you wish to request an EAD, please mail your application to the address in Table 1. After you submit your EAD application and receive a USCIS receipt number, please send an email to the Service Center handling your application. The email should include the receipt number and state that you submitted a request for an EAD based on an IJ/BIA grant of TPS. This will aid in the verification of your grant of TPS and processing of your EAD application, as USCIS may not have received records of your grant of TPS by either the IJ or the BIA. To obtain additional information, including the email address of the appropriate Service Center, you may go to the USCIS TPS Web page at
You cannot electronically file your application packet. Please mail your application packet to the mailing address listed in Table 1.
The filing instructions on the Application for Temporary Protected Status (Form I-821) list all the documents needed to establish basic eligibility for TPS. You may also find information on the acceptable documentation and other requirements for applying or registering for TPS on the USCIS Web site at
If one or more of the questions listed in Part 4, Question 2 of the Application for Temporary Protected Status (Form I-821) applies to you, then you must submit an explanation on a separate sheet(s) of paper and/or additional documentation.
To get case status information about your TPS application, including the status of a request for an EAD, you can check Case Status Online at
Provided that you currently have TPS under the designation of Somalia, this Notice automatically extends your EAD by 6 months if you:
• Are a national of Somalia (or an alien having no nationality who last habitually resided in Somalia);
• Have an EAD under the designation of TPS for Somalia with a marked expiration date of March 17, 2017, bearing the notation “A-12” or “C-19” on the face of the card under “Category.”
Although this Notice automatically extends your EAD through September 17, 2017, you must re-register timely for TPS in accordance with the procedures described in this Notice if you would like to maintain your TPS.
You can find a list of acceptable document choices on the “Lists of Acceptable Documents” for Form I-9. You can find additional detailed information on the USCIS I-9 Central Web page at
You may present any document from List A (reflecting both your identity and employment authorization) or one document from List B (reflecting identity) together with one document from List C (reflecting employment authorization). Alternatively, you may present an acceptable receipt for List A,
If your EAD has an expiration date of March 17, 2017, and states “A-12” or “C-19” under “Category,” it has been extended automatically for 6 months by virtue of this
Even though EADs with an expiration date of March 17, 2017, that state “A-12” or “C-19” under “Category” have been automatically extended for 6 months by this
By September 17, 2017, the expiration date of the automatic extension, your employer must reverify your employment authorization. At that time, you must present any document from List A or any document from List C on Form I-9 to reverify employment authorization, or an acceptable List A or List C receipt described in the Form I-9 Instructions. Your employer should complete either Section 3 of the Form I-9 originally completed for you or, if this Section has already been completed or if the version of Form I-9 has expired (check the date in the upper right-hand corner of the form), complete Section 3 of the most current version of Form I-9. Note that employers may not specify which List A or List C document employees must present and cannot reject an acceptable receipt.
No. When completing Form I-9, including re-verifying employment authorization, employers must accept any documentation that appears on the Lists of Acceptable Documents and that reasonably appears to be genuine and that relates to you or an acceptable List A, List B, or List C receipt. Employers may not request documentation that does not appear on the Lists of Acceptable Documents. Therefore, employers may not request proof of Somali citizenship or proof of re-registration for TPS when completing Form I-9 for new hires, making corrections, or reverifying the employment authorization of current employees. If presented with EADs that have been automatically extended, employers should accept such EADs as valid List A documents so long as the EADs reasonably appear to be genuine and to relate to the employee. Refer to the
After September 17, 2017, employers may no longer accept the EADs that this
When using an automatically extended EAD to complete Form I-9 for a new job prior to September 17, 2017, you and your employer should do the following:
1. For Section 1, you should:
a. Check “An alien authorized to work;”
b. Enter the automatically extended EAD expiration date (September 17, 2017) in the first space; and
c. Enter your Alien Number (USCIS number or A-Number) in the second space (your EAD or other document from DHS will have your USCIS number or A-Number printed on it; the USCIS number is the same as your A-Number without the A prefix).
2. For Section 2, employers should enter the:
a. Document title;
b. Issuing authority;
c. Document number; and
d. Automatically extended EAD expiration date (September 17, 2017).
By September 17, 2017, employers must reverify the employee's employment authorization in Section 3 of Form I-9.
If you are an existing employee who presented a TPS-related EAD that was valid when you first started your job, but that EAD has now been automatically extended, your employer may need to reinspect your automatically extended EAD if your employer does not have a copy of the EAD on file, and you and your employer should correct your previously completed Form I-9 as follows:
1. For Section 1, you should:
a. Draw a line through the expiration date in the first space;
b. Write “September 17, 2017,” above the previous date;
c. Write “TPS Ext.” in the margin of Section 1; and
d. Initial and date the correction in the margin of Section 1.
2. For Section 2, employers should:
a. Draw a line through the expiration date written in Section 2;
b. Write “September 17, 2017,” above the previous date;
c. Write “TPS Ext.” in the Additional Information field in Section 2; and
d. Initial and date the correction in the Additional Information field in Section 2.
By September 17, 2017, when the automatic extension of EADs expires, employers must reverify the employee's employment authorization in Section 3.
E-Verify automated the verification process for employees whose TPS status was automatically extended in a
Employers are reminded that the laws requiring proper employment eligibility verification and prohibiting unfair immigration-related employment practices remain in full force. This Notice does not supersede or in any way limit applicable employment verification rules and policy guidance, including those rules setting forth reverification requirements. For general questions about the employment eligibility verification process, employers may call USCIS at 888-464-4218 (TTY 877-875-6028) or email USCIS at
For general questions about the employment eligibility verification process, employees may call USCIS at 888-897-7781 (TTY 877-875-6028) or email at
To comply with the law, employers must accept any document or combination of documents from the Lists of Acceptable Documents for Form I-9 if the documentation reasonably appears to be genuine and to relate to the employee, or an acceptable List A, List B, or List C receipt described in the Form I-9 Instructions. Employers may not require extra or additional documentation beyond what is required for Form I-9 completion. Further, employers participating in E-Verify who receive an E-Verify case result of “Tentative Nonconfirmation” (TNC) must promptly and privately inform employees of the TNC and give such employees an opportunity to contest the TNC. A TNC case result means that the information entered into E-Verify from Form I-9 differs from Federal or state government records.
Employers may not terminate, suspend, delay training, withhold pay, lower pay, or take any adverse action against an employee based on the employee's decision to contest a TNC or because the case is still pending with E-Verify. A Final Nonconfirmation (FNC) case result is received when E-Verify cannot verify an employee's employment eligibility. An employer may terminate employment based on a case result of FNC. Work-authorized employees who receive an FNC may call USCIS for assistance at 888-897-7781 (TTY 877-875-6028). An employee who believes he or she was discriminated against by an employer in the E-Verify process based on citizenship or immigration status, or based on national origin, may contact OSC's Worker Information Hotline at 800-255-7688 (TTY 800-237-2515). Additional information about proper nondiscriminatory Form I-9 and E-Verify procedures is available on the OSC Web site at
While Federal Government agencies must follow the guidelines laid out by the Federal Government, state, and local government agencies establish their own rules and guidelines when granting certain benefits. Each state may have different laws, requirements, and determinations about what documents you need to provide to prove eligibility for certain benefits. Whether you are applying for a Federal, state, or local government benefit, you may need to provide the government agency with documents that show you are a TPS beneficiary and/or show you are authorized to work based on TPS. Examples are:
(1) Your unexpired EAD that has been automatically extended or your EAD that has not expired;
(2) A copy of this
(3) A copy of your Application for Temporary Protected Status Notice of Action (Form I-797) for this re-registration;
(4) A copy of your past or current Application for Temporary Protected Status Notice of Action (Form I-797), if you received one from USCIS; or
(5) If there is an automatic extension of work authorization, information from the USCIS TPS Web site that provides information about the automatic extension.
Check with the government agency regarding which document(s) the agency will accept. You may also provide the agency with a copy of this
Some benefit-granting agencies use the USCIS Systematic Alien Verification for Entitlements Program (SAVE) to confirm the current immigration status of applicants for public benefits. In most cases, SAVE provides an automated electronic response to benefit granting agencies within seconds but occasionally verification can be delayed. You can check the status of your SAVE verification by using CaseCheck at the following link:
Office of the Assistant Secretary for Community Planning and Development, HUD.
Notice.
This notice advises the public of an additional waiver applicable to the Community Development Block Grant Disaster Recovery (CDBG-DR) grants provided to the State of New York for the purpose of assisting in the recovery from the September 11, 2001, terrorist attacks on New York City. As described in the “Background” section of this notice, HUD is authorized by statute and regulations to waive statutory and regulatory requirements and specify alternative requirements for this purpose upon the request of the grantee.
Stanley Gimont, Director, Office of Block Grant Assistance, Department of Housing and Urban Development, 451 7th Street SW., Room 7286, Washington, DC 20410, telephone number 202-708-3587. Persons with hearing or speech impairments may access this number via TTY by calling the Federal Relay Service at 800-877-8339. Facsimile inquiries may be sent to Mr. Gimont at 202-401-2044. (Except for the “800” number, these telephone numbers are not toll-free.) Email inquiries may be sent to
Provisions of four public laws (the Appropriation Acts) govern the Community Development Block Grant Disaster Recovery (CDBG-DR) grants covered by this Notice:
• The fifth proviso under the 2001 Emergency Supplemental Appropriations Act for Recovery from and Response to Terrorist Attacks on the United States (Pub. L. 107-38, approved September 18, 2001);
• Section 434 of title IV of the Departments of Veterans Affairs and Housing and Urban Development, and Independent Agencies Appropriations Act, 2002 (Pub. L. 107-73, approved November 26, 2001);
• Chapter 13 of division B of the Department of Defense and Emergency Supplemental Appropriations for Recovery from and Response to Terrorist Attacks on the United States Act, 2002 (Pub. L. 107-117, approved January 10, 2002); and
• Chapter 13 of title II of the 2002 Supplemental Appropriations Act for Further Recovery from and Response to Terrorist Attacks on the United States (Pub. L. 107-206, approved August 2, 2002).
These Appropriation Acts funded three CDBG-DR grants: A single grant of $700 million awarded to Empire State Development Corporation (ESDC); and two grants of $2.0 billion and $783 million, respectively, awarded to the Lower Manhattan Development Corporation (LMDC). ESDC is a political subdivision and public benefit corporation of the state of New York and LMDC is a subsidiary of ESDC.
This Notice specifies waivers and alternative requirements and modifies previous requirements applicable to LMDC's grants under the Appropriation Acts, which are described in
LMDC administers CDBG-DR funds allocated to the organization for emergency expenses and economic revitalization in response to the September 11, 2001, terrorist attacks in New York City. LMDC is charged with assisting New York City in recovering from the terrorist attacks on the World Trade Center (WTC), in part by working with the Port Authority of New York and New Jersey (Port Authority). There are two components to this effort. The first is a “Memorial Program,” carried out by LMDC, that includes the construction of a Memorial and Memorial Museum (completed), and the planning and construction of other Memorial-related improvements to complement further redevelopment in the immediate area. The second component is a “Redevelopment Program,” carried out by the Port Authority, which includes commercial and retail space, open space areas, and other improvements. LMDC works closely with the Port Authority to effectuate the Redevelopment Program. For additional information regarding the roles and responsibilities of LMDC and the Port Authority and the World Trade Center Memorial and Cultural Program General Project Plan (GPP), please refer to the LDMC Web site at:
Consistent with its approved CDBG-DR action plan and amendments, LMDC used CDBG-DR funds to acquire and clear real property identified in the GPP as 130 Liberty Street and 140 Liberty Street. In order to enable LDMC to fully implement its Memorial Program and to enable the Port Authority to pursue its Redevelopment Program, LMDC proposes an exchange of real property interests with the Port Authority. The Port Authority will provide LMDC or its designee with a lease (up to 99 years) and purchase option for Port Authority-owned property that will be used for memorial and cultural facilities that are part of LMDC's Memorial Program, most specifically a performing arts center. This ownership structure will parallel a prior plan governing the site of the Memorial Museum, which was also part of the larger exchange of memorial and cultural properties dedicated for the Memorial Program. In the first phase of this exchange, the Port Authority will obtain title to the portions of 130 and 140 Liberty Street parcels necessary to finalize the below-grade WTC Vehicle Security Center with a public park, known as Liberty Park, at and above street level, and the St. Nicholas National Shrine at the World Trade Center, all of which are part of the Redevelopment Program. These portions of 130 and 140 Liberty Street have already been partially redeveloped by the Port Authority pursuant to an access agreement with LMDC. HUD must waive certain regulations applicable to the reuse of 130 and 140 Liberty Street to facilitate the current exchange
The proposed property exchange is a step toward finalizing a new site for St. Nicholas Greek Orthodox Church (St. Nicholas), which was destroyed by the collapse of the South Tower of the World Trade Center on September 11, 2001. St. Nicholas had been located at 155 Cedar Street, which is adjacent to the 130 and 140 Liberty Street parcels, but the WTC Memorial and Redevelopment Plan provides for reconstruction of St. Nicholas (as the St. Nicholas National Shrine at the World Trade Center) on a portion of 130 Liberty Street. To carry out this plan, the Port Authority entered into an agreement with St. Nicholas that will permit the Port Authority to acquire 155 Cedar Street from St. Nicholas in exchange for a long-term lease and purchase agreement on a portion of 130 Liberty Street.
As discussed below, reliable valuations of these properties are difficult to obtain but some components of the overall transaction can be evaluated in a more traditional manner. One such component involves the property interest that St. Nicholas will receive from the Port Authority in exchange for 155 Cedar Street. LMDC has carried out an analysis and determined that the properties are comparable, in part due to a permanent restrictive declaration limiting development of the property that will be transferred to St. Nicholas.
As part of the larger planned exchange between the Port Authority and LMDC, LMDC is transferring to the Port Authority the portions of 130 and 140 Liberty Street parcels necessary to finalize the WTC Vehicle Security Center, Liberty Park, and the St. Nicholas National Shrine at the World Trade Center. This transfer will not be considered to be CDBG-assisted and, therefore, will not be subject to CDBG requirements. As a result, the Port Authority's conveyance of a portion of 130 Liberty Street to St. Nicholas for the St. Nicholas National Shrine at the World Trade Center will not be assisted with CDBG-DR funds. Additionally, the Port Authority's proposed use of 155 Cedar Street and the portion of 130 and 140 Liberty Street that it receives from LMDC (minus the St. Nicholas transfer site) will not be subject to CDBG requirements.
HUD notes that LMDC never intended to retain long-term ownership of 130 and 140 Liberty Street. The properties were purchased with CDBG-DR funds to address conditions that developed as a result of the collapse of the Towers and to obtain open space adjacent to the World Trade Center site. Neither LMDC nor its parent organization, ESDC, holds real property for the long-term and it is LMDC's intention to transfer ownership of its holdings on the World Trade Center site in the future for eligible uses in support of long-term recovery.
The Appropriation Acts authorize the Secretary to waive, or specify alternative requirements for, any provision of any statute or regulation that the Secretary administers in connection with the obligation by the Secretary or use by the recipient of these grant funds, except for requirements related to fair housing, nondiscrimination, labor standards, and the environment, upon a finding that such waiver is required to facilitate the use of such funds, and would not be inconsistent with the overall purpose of the statute or regulation. Regulatory waiver authority is also provided by 24 CFR 5.110, 91.600, and 570.5.
The following waiver and alternative requirement (together with previously granted waivers and alternative requirements) is necessary to facilitate the use of these funds, and is not inconsistent with the overall purposes of the regulation or title I of the Housing and Community Development Act of 1974, as amended (42 U.S.C. 5301
Because the 130 and 140 Liberty Street parcels were acquired and cleared using CDBG-DR funds, LMDC's use of these parcels is subject to the CDBG “change of use of real property” provision at 24 CFR 570.489(j), which prohibits grantees from changing the use or planned use of a property acquired with CDBG-DR funds unless the new use of the property qualifies as meeting a national objective, or the grantee reimburses its program in the amount of the current fair market value of the property. This regulatory provision does not accommodate unique aspects present in LMDC's charge to undertake the Memorial Program and cooperate with the Port Authority in its implementation of the Redevelopment Program, and the realities associated with redevelopment of a nationally significant site in the heart of Lower Manhattan. For these reasons, the Department has determined that good cause exists to grant a waiver of 24 CFR 570.489(j) and establish an alternative requirement to facilitate the use of LMDC's CDBG-DR funds, allow the proposed property exchanges, and promote completion of the Memorial and Redevelopment Programs.
As an alternative requirement, HUD will permit LMDC to compensate its CDBG-DR program for funds expended on acquisition and clearance of 130 and 140 Liberty Street through acquisition (via long-term lease and purchase) of properties on the World Trade Center site from the Port Authority that are sufficient as sites for various memorial and cultural facilities, including the September 11 Memorial and Museum and the yet to be built performing arts center, as described in the GPP and LMDC's applicable Action Plan, as amended. The Department's decision is based on its finding that the properties involved in this transfer present unique valuation difficulties. The portions of 130 and 140 Liberty Street that LMDC will transfer will not be redeveloped for commercial uses but will serve public and non-profit purposes. Given that these parcels are located in Lower Manhattan, their value as commercial properties would be substantial but use for public and non-profit purposes alters their valuation. As a result, common appraisal approaches are not applicable to establishing current fair market valuations. Concurrently, the World Trade Center site is unique and venerated by the city and state of New York as well as the nation as a result of the tragedy that transpired on September 11, 2001. This status makes it exceptionally difficult, if not impossible, to establish reliable valuations of the real property interests on the World Trade Center site that are to be conveyed to LMDC. The difficulties in establishing current fair market valuations of the various parts of this transaction and the strong desire of all parties (including HUD) to facilitate redevelopment progress on and adjacent to the World Trade Center site more than fifteen years after the events of September 11, 2001, create a situation in which the waiver and alternative
HUD finds that good cause exists to waive 24 CFR 570.489(j) and impose an alternative requirement to the extent necessary to allow LMDC to transfer the portions of 130 and 140 Liberty Street necessary to finalize the WTC Vehicle Security Center, Liberty Park, and the St. Nicholas National Shrine at the World Trade Center to the Port Authority without reimbursing the CDBG-DR program for the fair market value of the properties. HUD is therefore waiving section 570.489(j) for this purpose and establishing an alternative requirement to permit LMDC to acquire from the Port Authority property on the World Trade Center site, via long-term lease and purchase, sufficient to carry out the memorial and cultural facilities on the World Trade Center site that are contemplated in the GPP and LMDC's applicable Action Plan, as amended. Additionally, the property to be acquired by LMDC on the World Trade Center site will be subject to CDBG-DR programmatic requirements upon transfer to LMDC. HUD recognizes the phased nature of the transactions contemplated by various parties pursuant to this alternative requirement. However, as part of this alternative requirement, if LMDC does not acquire property that is sufficient to carry out the memorial and cultural facilities on the World Trade Center site as contemplated in the GPP and LMDC's applicable Action Plan, as amended, before LMDC closes out its grants, HUD may pursue appropriate remedial actions.
This waiver and alternative requirement are consistent with the provisions of the Appropriation Acts and are necessary to facilitate LMDC's use of CDBG-DR funds for its Memorial Program.
The Catalog of Federal Domestic Assistance numbers for the disaster recovery grants under this Notice is 14.218 and 14.228.
A Finding of No Significant Impact (FONSI) with respect to the environment has been made in accordance with HUD regulations at 24 CFR part 50, which implement section 102(2)(C) of the National Environmental Policy Act of 1969 (42 U.S.C. 4332(2)(C)). The FONSI is available for public inspection between 8 a.m. and 5 p.m. weekdays in the Regulations Division, Office of General Counsel, Department of Housing and Urban Development, 451 7th Street, SW., Room 10276, Washington, DC 20410-0500. Due to security measures at the HUD Headquarters building, an advance appointment to review the docket file must be scheduled by calling the Regulations Division at 202-708-3055 (this is not a toll-free number). Hearing or speech-impaired individuals may access this number through TTY by calling the toll-free Federal Relay Service at 800-877-8339.
Office of Strategic Planning and Management, HUD.
Notice of Order of Succession.
In this notice, the Director of the Office of Strategic Planning and Management for the Department of Housing and Urban Development designates the Order of Succession for the Office of Strategic Planning and Management. This Order of Succession supersedes all prior Orders of Succession for the Office of Strategic Planning and Management.
Henry Hensley, Director, Office of Strategic Planning and Management, Department of Housing and Urban Development, 451 7th Street SW., Room 10162, Washington, DC 20410, telephone number (202) 402-4360 (this is not a toll free number). Persons with hearing or speech impairments may access this number by calling the toll free Federal Relay Service at (800) 877-8339.
The Director of the Office of Strategic Planning and Management for the Department of Housing and Urban Development is issuing this Order of Succession of officials authorized to perform the functions and duties of the Director of the Office of Strategic Planning and Management when, by reason of absence, disability, or vacancy in office, the Director is not available to exercise the powers or perform the duties of the office. This Order of Succession is subject to the provisions of the Federal Vacancies Reform Act of 1998 (5 U.S.C. 3345-3349d). This Order of Succession supersedes all prior Orders of Succession for the Office of Strategic Planning and Management.
Accordingly, the Director of the Office of Strategic Planning and Management designates the following Order of Succession:
During any period when, by reason of absence, disability, or vacancy in office, Director of the Office of Strategic Planning and Management for the Department of Housing and Urban Development is not available to exercise the powers or perform the duties of the Director of the Office of Strategic Planning and Management, the following officials within the Office of Strategic Planning and Management are hereby designated to exercise the powers and perform the duties of the Office. No individual who is serving in an office listed below in an acting capacity may act as the Director of the Office of Strategic Planning and Management pursuant to this Order of Succession.
These officials shall perform the functions and duties of the office in the order specified herein, and no official shall serve unless all the other officials, whose position titles precede his/hers in this order, are unable to act by reason of absence, disability, or vacancy in office.
This Order of Succession supersedes all prior Orders of Succession for the Office of Strategic Planning and Management.
Section 7(d), Department of Housing and Urban Development Act, 42 U.S.C. 3535(d).
Fish and Wildlife Service, Interior.
Notice of receipt of applications for permit.
We, the U.S. Fish and Wildlife Service, invite the public to comment on the following applications to conduct certain activities with endangered species. With some exceptions, the Endangered Species Act (ESA) prohibit activities with listed species unless Federal authorization is acquired that allows such activities.
We must receive comments or requests for documents on or before February 16, 2017.
•
•
When submitting comments, please indicate the name of the applicant and the PRT# you are commenting on. We will post all comments on
Brenda Tapia, (703) 358-2104 (telephone); (703) 358-2281 (fax);
Send your request for copies of applications or comments and materials concerning any of the applications to the contact listed under
Please make your requests or comments as specific as possible. Please confine your comments to issues for which we seek comments in this notice, and explain the basis for your comments. Include sufficient information with your comments to allow us to authenticate any scientific or commercial data you include.
The comments and recommendations that will be most useful and likely to influence agency decisions are: (1) Those supported by quantitative information or studies; and (2) Those that include citations to, and analyses of, the applicable laws and regulations. We will not consider or include in our administrative record comments we receive after the close of the comment period (see
Comments, including names and street addresses of respondents, will be available for public review at the street address listed under
To help us carry out our conservation responsibilities for affected species, and in consideration of section 10(a)(1)(A) of the Endangered Species Act of 1973, as amended (16 U.S.C. 1531
The applicant requests a permit to import biological samples of wild blue-throated macaw (
The applicant requests a permit to import 563 thick-billed parrot samples (
The applicant requests a permit to import bone samples from deceased wild collected Galapagos giant tortoise (
The following applicants each request a permit to import the sport-hunted trophy of one male bontebok (
Bureau of Indian Affairs, Interior.
Notice of final agency determination.
The Principal Deputy Assistant Secretary—Indian Affairs made a final agency determination to acquire 1.08 acres, more or less, of land in trust for the Craig Tribal Association, Alaska, for economic development and other purposes on January 10, 2017.
Helen Riggs, Director, Office of Trust Services, Bureau of Indian Affairs, MS-4620 MIB, 1849 C Street NW., Washington, DC 20240, telephone (202) 208-5831.
This notice is published in the exercise of authority delegated by the Secretary of the Interior to the Office of the Assistant Secretary—Indian Affairs by 209 Departmental Manual 8.1, and is published to comply with the requirements of 25 CFR 151.12 (c)(2)(ii) that notice of the decision to acquire land in trust be promptly provided in the
On January 10, 2017, the Principal Deputy Assistant Secretary—Indian Affairs issued a decision to accept approximately 1.08 acres, more or less, of land in trust for the Craig Tribal Association, Alaska, under the authority of the Indian Reorganization Act of 1934, 25 U.S.C. 465.
The Alaska Regional Director, on behalf of the Secretary of the Interior, will immediately acquire title in the name of the United States of America in trust for the Craig Tribal Association upon fulfillment of Departmental requirements.
The 1.08 acres, more or less, are located in the city of Craig, State of Alaska, and are described as follows:
Lot Q-3, subdivision of the unsubdivided remainder of Tract Q, U.S. Survey 2327, according to the plat thereof filed December 7, 1988, as plat No. 88-39, Ketchikan Recording District, State of Alaska, containing 1.08 acres.
Bureau of Indian Affairs, Interior.
Notice.
This notice publishes the current list of 567 Tribal entities recognized and eligible for funding and services from the Bureau of Indian Affairs (BIA) by virtue of their status as Indian Tribes. The list is updated from the notice published on May 4, 2016 (81 FR 26826).
Ms. Laurel Iron Cloud, Bureau of Indian Affairs, Division of Tribal Government Services, Mail Stop 4513-MIB, 1849 C Street NW., Washington, DC 20240. Telephone number: (202) 513-7641.
This notice is published pursuant to Section 104 of the Act of November 2, 1994 (Pub. L. 103-454; 108 Stat. 4791, 4792), and in exercise of authority delegated to the Assistant Secretary—Indian Affairs under 25 U.S.C. 2 and 9 and 209 DM 8.
Published below is an updated list of federally acknowledged Indian Tribes in the contiguous 48 states and Alaska, to reflect various name changes and corrections.
Amendments to the list include name changes and name corrections. To aid in identifying tribal name changes and corrections, the Tribe's previously listed or former name is included in parentheses after the correct current tribal name. We will continue to list the Tribe's former or previously listed name for several years before dropping the former or previously listed name from the list.
The listed Indian entities are acknowledged to have the immunities and privileges available to federally recognized Indian Tribes by virtue of their government-to-government relationship with the United States as well as the responsibilities, powers, limitations, and obligations of such Tribes. We have continued the practice of listing the Alaska Native entities separately solely for the purpose of facilitating identification of them and reference to them given the large number of complex Native names.
Bureau of Land Management, Interior.
Public land order.
This order partially revokes a withdrawal created by a Secretarial Order and a Bureau of Reclamation Order, insofar as they affect 2,643.25 acres withdrawn for the Bureau of Reclamation's Lonesome Lake Reservoir, a sub-unit of the Pick-Sloan Missouri Basin Program. The Bureau of Reclamation has determined that the lands are no longer needed for reclamation purposes.
This public land order is effective on January 17, 2017.
Cynthia Eide, Bureau of Land Management, Montana/Dakotas State Office, 5001 Southgate Drive, Billings, Montana 59101-4669; telephone 406-896-5094. Persons who use a telecommunications device for the deaf (TDD) may call the Federal Relay Service (FRS) at 1-800-877-8339 to contact the above individual. FRS is available 24 hours a day, 7 days a week, to leave a message or question with the above individual. You will receive a reply during normal business hours.
The Bureau of Reclamation has determined that the lands are no longer needed for reclamation purposes. The revocation is needed to allow for a majority of the lands to be conveyed to the State of Montana under a State Indemnity Selection application. Any lands not conveyed to the State, except 3.25 acres included in an overlapping withdrawal, will be restored to the administration of the Bureau of Land Management. In the event any lands described in Paragraphs 1 and 2 below are not conveyed to the State, those lands will remain segregated from location and entry under the United States mining laws unless later opened by publication of an opening order in accordance with applicable law.
By virtue of the authority vested in the Secretary of the Interior by Section 204 of the Federal Land Policy and Management Act of 1976, 43 U.S.C. 1714, it is ordered as follows:
1. The Secretarial Order dated October 15, 1904, which withdrew public lands on behalf of the Bureau of Reclamation for the Lonesome Lake Reservoir Site, is hereby partially revoked insofar as it affects the following described lands:
The areas described aggregate 2,480 acres in Chouteau and Hill Counties.
2. The Bureau of Reclamation Order dated March 30, 1950, which withdrew public lands for the Lonesome Lake Reservoir Site, is hereby partially revoked insofar as it affects the following described lands:
The areas described aggregate 163.25 acres in Chouteau, Hill, and Liberty Counties.
3. All of the lands described in Paragraphs 1 and 2, except for the 80.00 acres described in Paragraph 4 below, are hereby opened for disposal through State Indemnity Selection, but remain segregated from location and entry under the United States mining laws due to a State Indemnity Selection application.
4. At 9 a.m. on February 16, 2017, the following described lands will be restored to management by the Bureau of Land Management and are opened to the operation of the public land laws generally, subject to valid existing rights, the provisions of existing withdrawals, other segregations of record, and the requirements of applicable law. All valid applications received at or prior to 9 a.m. on February 16, 2017, shall be considered as simultaneously filed at that time. Those received thereafter shall be considered in the order of filing.
The areas described aggregate 80.00 acres in Chouteau County.
5. At 9 a.m. on February 16, 2017, the lands described in Paragraph 4 will be opened to location and entry under the United States mining laws, subject to valid existing rights, the provision of existing withdrawals, other segregations of record, and the requirements of applicable law. The lands have been and will remain open to mineral leasing. Appropriation of any of the lands described in this order under the general mining laws prior to the date and time of restoration is unauthorized. Any such attempted appropriation, including attempting adverse possession under 30 U.S.C. 38, shall vest no rights against the United States. Acts required to establish a location and to initiate a right of possession are governed by state law where not in conflict with Federal law. The Bureau of Land Management will not intervene in disputes between rival locators over possessory rights since Congress has provided for such determinations in local courts.
National Park Service, Interior
Notice of availability of the Final Environmental Impact Statement for the Off-road Vehicle Management Plan, Glen Canyon National Recreation Area.
The National Park Service (NPS) announces the availability of a Final Environmental Impact Statement (Plan/FEIS) for the Off-road Vehicle Management Plan, Glen Canyon National Recreation Area (GLCA), located in Arizona and Utah. The Plan/FEIS evaluates the impacts of four action alternatives that address off-road vehicle (ORV) management. It also assesses the impacts that could result from continuing the current management framework in the no-action alternative.
The NPS will execute a Record of Decision (ROD) no sooner than 30 days following publication by the Environmental Protection Agency of the Notice of Availability of the Final Environmental Impact Statement for the Off-road Vehicle Management Plan.
The Plan/FEIS will be available in electronic format online through the NPS Planning, Environment, and Public Comment Web site (
Teri Tucker, Assistant Superintendent, Glen Canyon National Recreation Area, P.O. Box 1507, Page, Arizona 86040, by phone at 928-608-6207, or by email at
The purpose of this Plan/FEIS is to evaluate off-road use and on-road all-terrain vehicle (ATV) use and develop management actions that preserve Glen Canyon's scientific, scenic, and historic features; provide for the recreational use and enjoyment of the area; and promote the resources and values for which the area was established as a unit of the national park system. This Plan/FEIS does not adjudicate, analyze, or otherwise determine the validity of R.S. 2477 right-of-way claims.
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This document was received for publication by the Office of the Federal Register on January 11, 2017.
U.S. International Trade Commission.
Notice.
Notice is hereby given that the U.S. International Trade Commission has determined not to review an initial determination (“ID”) (Order No. 6) of the presiding administrative law judge (“ALJ”), terminating the above-captioned investigation based on a settlement agreement. The Commission has
Clint Gerdine, Esq., Office of the General Counsel, U.S. International Trade Commission, 500 E Street SW., Washington, DC 20436, telephone (202) 708-2310. Copies of non-confidential documents filed in connection with this investigation are or will be available for inspection during official business hours (8:45 a.m. to 5:15 p.m.) in the Office of the Secretary, U.S. International Trade Commission, 500 E Street SW., Washington, DC 20436, telephone (202) 205-2000. General information concerning the Commission may also be obtained by accessing its Internet server at
The Commission instituted this investigation on September 19, 2016, based on a complaint filed on behalf of Rockwell Automation, Inc. of Milwaukee, Wisconsin. 81 FR 64196-97. The complaint, as supplemented, alleged violations of section 337 of the Tariff Act of 1930, as amended, 19 U.S.C. 1337, by reason of infringement of the following U.S. Patent Nos.: 6,675,226; 6,816,817; 6,819,960; 6,978,225; 7,130,704; 7,650,196; 7,693,585; and 8,799,800. The complaint further alleged that a domestic industry exists. The Commission's notice of investigation named 3S-Smart Software Solutions, GmbH of Kempten, Germany; Advantech Corporation of Milpitas, California; and Advantech Co., Ltd. of Taipei City, Taiwan as respondents. The Office of Unfair Import Investigations (“OUII”) is also a party to the investigation.
On November 15, 2016, the complainant and all respondents jointly moved to terminate the investigation based on a settlement agreement. OUII supported the motion.
The ALJ issued the subject ID on December 15, 2016, granting the motion for termination of the investigation. She found that the motion for termination satisfied Commission Rules 210.21(a)(1), (b)(1) and that termination of the investigation is not contrary to the public interest. She also issued a corrected ID on December 19, 2016, to attach a copy of the settlement agreement. No petitions for review were filed.
The Commission has determined not to review the ID and has terminated the investigation.
The authority for the Commission's determination is contained in section 337 of the Tariff Act of 1930, as amended, 19 U.S.C. 1337, and in part 210 of the Commission's Rules of Practice and Procedure, 19 CFR part 210.
By order of the Commission.
Notice is hereby given that, on December 22, 2016, pursuant to Section 6(a) of the National Cooperative Research and Production Act of 1993, 15 U.S.C. 4301
No other changes have been made in either the membership or planned activity of the group research project. Membership in this group research project remains open, and UHD Alliance intends to file additional written notifications disclosing all changes in membership.
On June 17, 2015, UHD Alliance filed its original notification pursuant to Section 6(a) of the Act. The Department of Justice published a notice in the
The last notification was filed with the Department on September 28, 2016. A notice was published in the
Office for Victims of Crime, Department of Justice.
60-Day notice.
The Department of Justice (DOJ), Office of Justice Programs, Office for Victims of Crime, will be submitting the following information collection request to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act of 1995.
Comments are encouraged and will be accepted for 60 days until March 20, 2017.
If you have additional comments especially on the estimated public burden or associated response time, suggestions, or need a copy of the proposed information collection instrument with instructions or additional information, please contact Shelby Jones Crawford, Program Manager, Office for Victims of Crime, Office of Justice Programs, Department of Justice, 810 7th Street NW., Washington, DC 20530.
Written comments and suggestions from the public and affected agencies concerning the proposed collection of information are encouraged. Your comments should address one or more of the following four points:
Overview of this information collection:
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Abstract: The current package for OMB approval is designed to simplify performance reporting for OVC grantees through the OVC Trafficking Information Management System (TIMS) Online system, a Web-based database and reporting system for the Victims of Human Trafficking Grant and the Enhanced Collaborative Model Grant initiatives. OVC will require OVC Grantees to use this electronic tool to submit grant performance data, including demographics about human trafficking victims. Since 2012, OVC has published annual analyses of these data to provide the crime victims' field with stronger evidence for practices and programs.
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If additional information is required contact: Melody Braswell, Department Clearance Officer, United States Department of Justice, Justice Management Division, Policy and Planning Staff, Two Constitution Square, 145 N Street NE., 3E.405B, Washington, DC 20530.
Notice.
The Department of Labor is submitting the Office of Workers' Compensation Programs (OWCP) sponsored information collection request (ICR) revision titled, “Notice of Law Enforcement Officer's Injury or Occupational Disease and Notice of Law Enforcement Officer's Death,” to the Office of Management and Budget (OMB) for review and approval for use in accordance with the Paperwork Reduction Act (PRA) of 1995. Public comments on the ICR are invited.
The OMB will consider all written comments that agency receives on or before February 16, 2017.
A copy of this ICR with applicable supporting documentation; including a description of the likely respondents, proposed frequency of response, and estimated total burden may be obtained free of charge from the
Submit comments about this request by mail or courier to the Office of Information and Regulatory Affairs, Attn: OMB Desk Officer for DOL-OWCP, Office of Management and Budget, Room 10235, 725 17th Street NW., Washington, DC 20503; by Fax: 202-395-5806 (this is not a toll-free number); or by email:
Contact Michel Smyth by telephone at 202-693-4129, TTY 202-693-8064, (these are not toll-free numbers) or sending an email to
This ICR seeks approval under the PRA for revisions to the Notice of Law Enforcement Officer's Injury or Occupational Disease and Notice of Law Enforcement Officer's Death information collection. Form CA-721, Notice of Law Enforcement Officer's Injury or Occupational Disease, and Form CA-722, Notice of Law Enforcement Officer's Death, are used for filing claims for compensation for injury and death to non-Federal law enforcement officers under Federal Employees' Compensation Act (FECA) provisions that provide compensation for law enforcement officers not employed by the U.S. killed or injured while apprehending persons suspected of committing Federal crimes.
This information collection is subject to the PRA. A Federal agency generally cannot conduct or sponsor a collection of information, and the public is generally not required to respond to an information collection, unless it is approved by the OMB under the PRA and displays a currently valid OMB Control Number. In addition, notwithstanding any other provisions of law, no person shall generally be subject to penalty for failing to comply with a collection of information that does not display a valid Control Number.
Interested parties are encouraged to send comments to the OMB, Office of Information and Regulatory Affairs at the address shown in the
• Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility;
• Evaluate the accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used;
• Enhance the quality, utility, and clarity of the information to be collected; and
• Minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology,
44 U.S.C. 3507(a)(1)(D).
10:00 a.m., Thursday, January 19, 2017.
Board Room, 7th Floor, Room 7047, 1775 Duke Street (All visitors must use Diagonal Road Entrance), Alexandria, VA 22314-3428.
Open.
Gerard Poliquin, Secretary of the Board, Telephone: 703-518-6304.
Nuclear Regulatory Commission.
Draft NUREG; extension of comment period.
On December 16, 2016, the U.S. Nuclear Regulatory Commission (NRC) solicited comments on draft NUREG-1556, Volume 21, Revision 1, “Consolidated Guidance About Materials Licenses: Program-Specific Guidance About Possession Licenses for Production of Radioactive Material Using an Accelerator.” The public comment period was originally scheduled to close on January 20, 2017. The NRC has decided to extend the public comment period to allow more time for members of the public to develop and submit their comments.
The due date of comments requested in the document published on December 16, 2016 (81 FR 91206) is extended. Comments should be filed no later than February 24, 2017. Comments received after this date will be considered if it is practical to do so, but the NRC is able to ensure consideration only for comments received on or before this date.
You may submit comments by any of the following methods (unless this document describes a different method for submitting comments on a specific subject):
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For additional direction on accessing information and submitting comments, see “Obtaining Information and Submitting Comments” in the
Robert MacDougall, Office of Nuclear Material Safety and Safeguards; U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001; telephone: 301-415-5175; email:
Please refer to Docket ID NRC-2016-0158 when contacting the NRC about the availability of information regarding this document. You may obtain publicly-available information related to this action by the following methods:
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The draft NUREG-1556, Volume 21, Revision 1, is also available on the NRC's public Web site on: (1) The “Consolidated Guidance About Materials Licenses (NUREG-1556)” page at
Please include Docket ID NRC-2016-0158 in the subject line of your comment submission, in order to ensure that the NRC is able to make your comment submission available to the public in this docket.
The NRC cautions you not to include identifying or contact information that you do not want to be publicly disclosed in your comment submission. The NRC posts all comment submissions at
If you are requesting or aggregating comments from other persons for submission to the NRC, then you should inform those persons not to include identifying or contact information that they do not want to be publicly disclosed in their comment submission. Your request should state that the NRC does not routinely edit comment submissions to remove such information before making the comment submissions available to the public or entering the comment submissions into ADAMS.
On December 16, 2016, the NRC solicited comments on draft NUREG-1556, Volume 21, Revision 1, “Consolidated Guidance About Materials Licenses: Program-Specific Guidance About Possession Licenses for Production of Radioactive Material Using an Accelerator.”
The purpose of the document published on December 16, 2016 (81 FR 91206) was to provide the public an opportunity to review and comment on draft NUREG-1556, Volume 21, Revision 1. This NUREG provides guidance both to current holders of possession licenses for radioactive material produced in an accelerator and to persons preparing applications for such licenses. The NUREG also provides the NRC criteria for evaluating a license application.
The public comment period was originally scheduled to close on January 20, 2017. The NRC has decided to extend the public comment period on this document until February 24, 2016, to allow more time for members of the public to submit their comments.
For the U.S. Nuclear Regulatory Commission.
Nuclear Regulatory Commission.
Biweekly notice.
Pursuant to Section 189a.(2) of the Atomic Energy Act of 1954, as amended (the Act), the U.S. Nuclear Regulatory Commission (NRC) is publishing this regular biweekly notice. The Act requires the Commission to publish notice of any amendments issued, or proposed to be issued, and grants the Commission the authority to issue and make immediately effective any amendment to an operating license or combined license, as applicable, upon a determination by the Commission that such amendment involves no significant hazards consideration, notwithstanding the pendency before the Commission of a request for a hearing from any person.
This biweekly notice includes all notices of amendments issued, or proposed to be issued, from December 20, 2016 to December 30, 2016. The last biweekly notice was published on January 3, 2016.
Comments must be filed by February 16, 2017. A request for a hearing must be filed by March 20, 2017.
You may submit comments by any of the following methods:
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For additional direction on obtaining information and submitting comments, see “Obtaining Information and Submitting Comments” in the
Kay Goldstein, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001; telephone: 301-415-1506, email:
Please refer to Docket ID NRC-2017-0002 when contacting the NRC about the availability of information for this action. You may obtain publicly-available information related to this action by any of the following methods:
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Please include Docket ID NRC-2017-0002, facility name, unit number(s), plant docket number, application date, and subject in your comment submission.
The NRC cautions you not to include identifying or contact information that you do not want to be publicly disclosed in your comment submission. The NRC will post all comment submissions at
If you are requesting or aggregating comments from other persons for submission to the NRC, then you should
The Commission has made a proposed determination that the following amendment requests involve no significant hazards consideration. Under the Commission's regulations in § 50.92 of title 10 of the
The Commission is seeking public comments on this proposed determination. Any comments received within 30 days after the date of publication of this notice will be considered in making any final determination.
Normally, the Commission will not issue the amendment until the expiration of 60 days after the date of publication of this notice. The Commission may issue the license amendment before expiration of the 60-day period provided that its final determination is that the amendment involves no significant hazards consideration. In addition, the Commission may issue the amendment prior to the expiration of the 30-day comment period if circumstances change during the 30-day comment period such that failure to act in a timely way would result, for example in derating or shutdown of the facility. If the Commission takes action prior to the expiration of either the comment period or the notice period, it will publish in the
Within 60 days after the date of publication of this notice, any persons (petitioner) whose interest may be affected by this action may file a request for a hearing and petition for leave to intervene (petition) with respect to the action. Petitions shall be filed in accordance with the Commission's “Agency Rules of Practice and Procedure” in 10 CFR part 2. Interested persons should consult a current copy of 10 CFR 2.309. The NRC's regulations are accessible electronically from the NRC Library on the NRC's Web site at
As required by 10 CFR 2.309(d) the petition should specifically explain the reasons why intervention should be permitted with particular reference to the following general requirements for standing: (1) The name, address, and telephone number of the petitioner; (2) the nature of the petitioner's right under the Act to be made a party to the proceeding; (3) the nature and extent of the petitioner's property, financial, or other interest in the proceeding; and (4) the possible effect of any decision or order which may be entered in the proceeding on the petitioner's interest.
In accordance with 10 CFR 2.309(f), the petition must also set forth the specific contentions which the petitioner seeks to have litigated in the proceeding. Each contention must consist of a specific statement of the issue of law or fact to be raised or controverted. In addition, the petitioner must provide a brief explanation of the bases for the contention and a concise statement of the alleged facts or expert opinion which support the contention and on which the petitioner intends to rely in proving the contention at the hearing. The petitioner must also provide references to the specific sources and documents on which the petitioner intends to rely to support its position on the issue. The petition must include sufficient information to show that a genuine dispute exists with the applicant or licensee on a material issue of law or fact. Contentions must be limited to matters within the scope of the proceeding. The contention must be one which, if proven, would entitle the petitioner to relief. A petitioner who fails to satisfy the requirements at 10 CFR 2.309(f) with respect to at least one contention will not be permitted to participate as a party.
Those permitted to intervene become parties to the proceeding, subject to any limitations in the order granting leave to intervene. Parties have the opportunity to participate fully in the conduct of the hearing with respect to resolution of that party's admitted contentions, including the opportunity to present evidence, consistent with the NRC's regulations, policies, and procedures.
Petitions must be filed no later than 60 days from the date of publication of this notice. Petitions and motions for leave to file new or amended contentions that are filed after the deadline will not be entertained absent a determination by the presiding officer that the filing demonstrates good cause by satisfying the three factors in 10 CFR 2.309(c)(1)(i) through (iii). The petition must be filed in accordance with the filing instructions in the “Electronic Submissions (E-Filing)” section of this document.
If a hearing is requested, and the Commission has not made a final determination on the issue of no significant hazards consideration, the Commission will make a final determination on the issue of no significant hazards consideration. The final determination will serve to establish when the hearing is held. If the final determination is that the amendment request involves no significant hazards consideration, the Commission may issue the amendment and make it immediately effective, notwithstanding the request for a hearing. Any hearing would take place after issuance of the amendment. If the final determination is that the amendment request involves a significant hazards consideration, then any hearing held would take place before the issuance of the amendment unless the Commission finds an imminent danger to the health or safety of the public, in which case it will issue an appropriate order or rule under 10 CFR part 2.
A State, local governmental body, Federally-recognized Indian Tribe, or agency thereof, may submit a petition to the Commission to participate as a party under 10 CFR 2.309(h)(1). The petition should state the nature and extent of the petitioner's interest in the proceeding. The petition should be submitted to the Commission by March 20, 2017. The petition must be filed in accordance with the filing instructions in the
If a hearing is granted, any person who is not a party to the proceeding and is not affiliated with or represented by a party may, at the discretion of the presiding officer, be permitted to make a limited appearance pursuant to the provisions of 10 CFR 2.315(a). A person making a limited appearance may make an oral or written statement of his or her position on the issues but may not otherwise participate in the proceeding. A limited appearance may be made at any session of the hearing or at any prehearing conference, subject to the limits and conditions as may be imposed by the presiding officer. Details regarding the opportunity to make a limited appearance will be provided by the presiding officer if such sessions are scheduled.
All documents filed in NRC adjudicatory proceedings, including a request for hearing and petition for leave to intervene (petition), any motion or other document filed in the proceeding prior to the submission of a request for hearing or petition to intervene, and documents filed by interested governmental entities that request to participate under 10 CFR 2.315(c), must be filed in accordance with the NRC's E-Filing rule (72 FR 49139; August 28, 2007, as amended at 77 FR 46562, August 3, 2012). The E-Filing process requires participants to submit and serve all adjudicatory documents over the internet, or in some cases to mail copies on electronic storage media. Detailed guidance on making electronic submissions may be found in the Guidance for Electronic Submissions to the NRC and on the NRC Web site at
To comply with the procedural requirements of E-Filing, at least 10 days prior to the filing deadline, the participant should contact the Office of the Secretary by email at
Information about applying for a digital ID certificate is available on the NRC's public Web site at
A person filing electronically using the NRC's adjudicatory E-Filing system may seek assistance by contacting the NRC's Electronic Filing Help Desk through the “Contact Us” link located on the NRC's public Web site at
Participants who believe that they have a good cause for not submitting documents electronically must file an exemption request, in accordance with 10 CFR 2.302(g), with their initial paper filing stating why there is good cause for not filing electronically and requesting authorization to continue to submit documents in paper format. Such filings must be submitted by: (1) First class mail addressed to the Office of the Secretary of the Commission, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001, Attention: Rulemaking and Adjudications Staff; or (2) courier, express mail, or expedited delivery service to the Office of the Secretary, 11555 Rockville Pike, Rockville, Maryland 20852, Attention: Rulemaking and Adjudications Staff. Participants filing adjudicatory documents in this manner are responsible for serving the document on all other participants. Filing is considered complete by first-class mail as of the time of deposit in the mail, or by courier, express mail, or expedited delivery service upon depositing the document with the provider of the service. A presiding officer, having granted an exemption request from using E-Filing, may require a participant or party to use E-Filing if the presiding officer subsequently determines that the reason for granting the exemption from use of E-Filing no longer exists.
Documents submitted in adjudicatory proceedings will appear in the NRC's electronic hearing docket which is available to the public at
For further details with respect to these license amendment applications, see the application for amendment which is available for public inspection in ADAMS and at the NRC's PDR. For additional direction on accessing information related to this document, see the “Obtaining Information and Submitting Comments” section of this document.
1. Does the proposed change involve a significant increase in the probability or consequences of an accident previously evaluated?
The proposed change affects various BSEP, CNS, MNS, HNP, and RNP SRs that currently require ventilation systems to be periodically operated for 10 continuous hours. These SRs would be modified to require operation for 15 continuous minutes.
These systems are not accident initiators and therefore, these changes do not involve a significant increase in the probability of an accident. The proposed system and filter testing changes are consistent with current regulatory guidance for these systems and will continue to assure that these systems perform their design function, which may include mitigating accidents. Thus, the change does not involve a significant increase in the consequences of an accident.
Therefore, it is concluded that this change does not involve a significant increase in the probability or consequences of an accident previously evaluated.
2. Does the proposed change create the possibility of a new or different kind of accident from any accident previously evaluated?
The proposed change affects various BSEP, CNS, MNS, HNP, and RNP SRs that currently require ventilation systems to be periodically operated for 10 continuous hours. These SRs would be modified to require operation for 15 continuous minutes.
The change proposed for these ventilation systems does not change any system operations or maintenance activities. Testing requirements will be revised and will continue to demonstrate that the Limiting Conditions for Operation are met and the system components are capable of performing their intended safety functions. The change does not create new failure modes or mechanisms and no new accident precursors are generated.
Therefore, it is concluded that this change does not create the possibility of a new or different kind of accident from any accident previously evaluated.
3. Does the proposed change involve a significant reduction in a margin of safety?
The proposed change affects various BSEP, CNS, MNS, HNP, and RNP SRs that currently require ventilation systems to be periodically operated for 10 continuous hours. These SRs would be modified to require operation for 15 continuous minutes.
The design basis for the BSEP, HNP, and RNP ventilation systems' heaters is to heat the incoming air, thereby reducing the relative humidity. The proposed change will continue to demonstrate that the heaters are capable of heating the air and will perform their design function.
The CNS and MNS ventilation systems are tested at 95 percent relative humidity, and, therefore, do not require heaters to heat the incoming air and reduce the relative humidity.
These proposed changes are consistent with regulatory guidance, and do not involve a significant reduction in a margin of safety.
Based on this review, it appears that the three standards of 10 CFR 50.92(c) are satisfied.
Therefore, the NRC staff proposes to determine that the amendment request involves no significant hazards consideration.
1. Does the proposed change involve a significant increase in the probability or consequences of an accident previously evaluated?
The proposed change revises the definition of SDM. SDM is not an initiator to any accident previously evaluated. Accordingly, the proposed change to the definition of SDM has no effect on the probability of any accident previously evaluated. SDM is an assumption in the analysis of some previously evaluated accidents, and inadequate SDM could lead to an increase in consequences for those accidents. However, the proposed change revises the SDM definition to ensure that the correct SDM is determined for all fuel types at all times during the fuel cycle. As a result, the proposed change does not adversely affect the consequences of any accident previously evaluated.
Therefore, the proposed change does not involve a significant increase in the probability or consequences of an accident previously evaluated.
2. Does the proposed change create the possibility of a new or different kind of accident from any accident previously evaluated?
The proposed change revises the definition of SDM. The change does not involve a physical alteration of the plant (
Therefore, the proposed change does not create the possibility of a new or different kind of accident from any accident previously evaluated.
3. Does the proposed change involve a significant reduction in a margin of safety?
The proposed change revises the definition of SDM. The proposed change does not alter the manner in which safety limits, limiting safety system settings or limiting conditions for operation are determined. The proposed change ensures that the SDM assumed in determining safety limits, limiting safety system settings or limiting conditions for operation is correct for all BWR fuel types at all times during the fuel cycle.
Therefore, the proposed change does not involve a significant reduction in a margin of safety.
The NRC staff has reviewed the licensee's analysis and, based on this review, it appears that the three standards of 10 CFR 50.92(c) are satisfied. Therefore, the NRC staff proposes to determine that the amendment request involves no significant hazards consideration.
1. Does the proposed amendment involve a significant increase in the probability or consequences of an accident previously evaluated?
This LAR [license amendment request] revises the methodology used to re-evaluate or design new modifications to the existing Auxiliary Building. All other structures will continue to utilize the current license basis and thus are not affected by this change. The proposed change allows evaluations of the Auxiliary Building to apply the ultimate strength design (USD) method from the ACI 318-63 Code for normal operating/service load combinations.
The ACI USD method is an accepted industry standard used for the design and analysis of reinforced concrete. A change in the methodology that an analysis uses to verify structure qualifications does not have any impact on the probability of accidents previously evaluated. Designs performed with the ACI USD method will continue to demonstrate that the Auxiliary Building meets industry accepted ACI Code requirements. This LAR does not propose changes to the no loss-of-function loads, loading combinations, or required USD capacity.
The use of increased concrete strength based on original test data for the areas identified in Section 2.3 of this document and the use of higher steel yield strength maintain adequate structural capacity. As such, these proposed changes do not pose a significant increase in the probability or consequences of an accident previously evaluated because the revised strength values are determined based on actual original test data using a high level of confidence.
The controlled hydrostatic load is changed from live load to dead load for USD in the definition. This is consistent with ACI-349-97 [American Concrete Institute Code Requirements for Nuclear Safety Related Concrete Structures] and therefore does not pose a significant increase in the probability or consequences of an accident previously evaluated.
Therefore, the proposed changes do not involve a significant increase in the probability or consequences of an accident previously evaluated.
2. Does the proposed amendment create the possibility of a new or different kind of accident from any accident previously evaluated?
This LAR proposes no physical change to any plant system, structure, or component. Similarly, no changes to plant operating practices, operating procedures, computer firmware, or computer software are proposed. This LAR does not propose changes to the design loads used to design Class I structures. Application of the new methodology to the design or evaluation of the Auxiliary Building will continue to ensure the Auxiliary Building will adequately house and protect equipment important to safety.
Calculations that use the ACI USD method for normal operating/service load combinations will continue to demonstrate that the concrete structures meet required design criteria. Use of the increased compressive strength of concrete based on 28-day test data (not age hardening) is permitted by the ACI 318-63 Code and ensures that the concrete structure is capable of performing its design function without alteration or compensatory actions of any kind. A higher steel yield has minimal reduction on design margin. The controlled hydrostatic load is changed from live load to dead load for USD in the definition which is consistent with ACI-349-97.
The use of these alternative methodologies for qualifying the Auxiliary Building does not have a negative impact on the ability of the structure or its components to house and protect equipment important to safety and thus, does not create the possibility of a new or different kind of accident from any previously evaluated.
3. Does the proposed amendment involve a significant reduction in a margin of safety?
The proposed change is for the design of new modifications or re-analysis of the Auxiliary Building.
Utilization of the ACI 318-63 Code USD method applies only to the normal operating/service load cases and is already part of the current license basis (CLB) for no loss-of-function load cases. No changes to design basis loads are proposed; therefore, new designs or re-evaluations of the Auxiliary Building shall still prove capable of coping with design basis loads.
Use of the increased compressive strength of concrete based on 28-day test data is justified and further constrained by limiting its application to areas where the concrete is not exposed to excessive moisture (
Therefore, the proposed changes do not involve a significant reduction in a margin of safety.
The NRC staff has reviewed the licensee's analysis and, based on this review, it appears that the three standards of 10 CFR 50.92(c) are satisfied. Therefore, the NRC staff proposes to determine that the amendment request involves no significant hazards consideration.
1. Does the proposed amendment involve a significant increase in the probability or consequences of an accident previously evaluated?
The proposed change removes the Fire Protection License Condition which is applicable to an operating reactor. Because FCS is permanently defueled, the proposed change does not involve a significant increase in the probability or consequences of an accident previously evaluated because: (1) The proposed amendment does not alter, degrade, or prevent action described or assumed in any accident in the USAR [Updated Safety Analysis Report] from being performed, (2) the proposed amendment does not alter any assumptions previously made in evaluating radiological consequences, and (3) the proposed amendment does not affect the integrity of any fission product barrier.
Therefore, the proposed change does not involve a significant increase in the probability or consequences of an accident previously evaluated.
2. Does the proposed amendment create the possibility of a new or different kind of accident from any accident previously evaluated?
The proposed change does not alter any, safety limits, or safety analysis assumptions associated with the operation of the plant. The proposed change does not introduce any new accident initiators, nor does the change reduce or adversely affect the capabilities of any plant structure or system in the performance of its safety function.
Therefore, the proposed change does not create the possibility of a new or different kind of accident from any previously evaluated.
3. Does the proposed amendment involve a significant reduction in a margin of safety?
The proposed change does not alter the manner in which safety limits or limiting safety system settings are determined. The safety analysis acceptance criteria are not affected by the proposed change. The proposed change does not change the design function of any equipment assumed to operate in the event of an accident.
Therefore, the proposed change does not involve a significant reduction in a margin of safety.
The NRC staff has reviewed the licensee's analysis and, based on this review, it appears that the three standards of 10 CFR 50.92(c) are satisfied. Therefore, the NRC staff proposes to determine that the amendment request involves no significant hazards consideration.
1. Does the proposed change involve a significant increase in the probability
or consequences of an accident previously evaluated?
The proposed changes to the TS modify Accident Monitoring Instrumentation TS Tables 3.3-11 and 4.3-11 of Salem Units 1 and 2 by removing or adding instruments as listed [in the amendment request], and updating the AOT [allowed outage time] and required actions to better align with the Westinghouse STS [Standard Technical Specifications], NUREG-1431. The instruments listed [in the amendment request] are not assumed to be initiators of any analyzed event of Chapter 15 in the Updated Final Safety Analysis Report (UFSAR). Therefore the probability of an accident previously evaluated is not significantly increased.
The proposed changes do not alter the design of any system, structure, or component (SSC). The proposed changes conform to NRC regulatory guidance regarding the content of plant TS, as identified in 10 CFR 50.36, NUREG-1431, and the NRC Final Policy Statement in 58 FR 39132.
TS Operability requirements are retained for Type A and Category 1 variables. Operability of these instruments ensures sufficient information is available to monitor and assess plant status during and following an accident. Alternate means for diagnosing and responding to instrument malfunctions are unaffected by the proposed change. Therefore, the consequences of an accident previously evaluated are not significantly increased.
Therefore, these proposed changes do not represent a significant increase in the probability or consequences of an accident previously evaluated.
2. Does the proposed change create the possibility of a new or different kind of accident from any accident previously evaluated?
The proposed changes to the TS would modify the TS Tables 3.3-11 and 4.3-11 of Salem Units 1 and 2, by removing or adding instruments as listed [in the amendment request], and updating the AOT and required actions to better align with the Westinghouse STS. The proposed changes do not involve a modification to the physical configuration of the plant or changes in the methods governing normal plant operation. The proposed changes will not impose any new or different requirement or introduce a new accident initiator, accident precursor, or malfunction mechanism.
Additionally, there is no change in the types or increases in the amounts of any effluent that may be released off-site and there is no increase in individual or cumulative occupational exposure.
Therefore, the proposed changes do not create the possibility of a new or different kind of accident from any accident previously evaluated.
3. Do the proposed changes involve a significant reduction in a margin of safety?
The proposed changes to the TS would modify the TS Tables 3.3-11 and 4.3-11 of Salem Units 1 and 2, by removing or adding instruments as listed [in the amendment request], and updating the AOT and required actions to better align with the Westinghouse STS. The instruments removed from Tables 3.3-11 and 4.3-11 are not needed for manual operator action necessary for safety systems
Therefore, since the proposed changes do not impact the response of the plant to a design basis accident, the proposed changes do not involve a significant reduction in a margin of safety.
The NRC staff has reviewed the licensee's analysis and, based on this review, it appears that the three standards of 10 CFR 50.92(c) are satisfied. Therefore, the NRC staff proposes to determine that the amendment request involves no significant hazards consideration.
The license amendment request was original noticed in the
1. Does the proposed change involve a significant increase in the probability or consequences of an accident previously evaluated?
The proposed TS change deletes Action Statement 3.4.2.1.b concerning safety/relief valves and revises TS Action Statement 3.6.2.1.b to be consistent with the BWR Standard Technical Specifications (NUREG-1433, “Standard Technical Specifications General Electric Plants, BWR/4,” Revision 4, dated April 2012). The two (2) minute action represents detailed methods of responding to an event, and therefore, if eliminated, would not result in increasing the probability of the event, nor act as an initiator of an event. Limiting condition for operation 3.6.2.1, “Depressurization Systems—Suppression Chamber,” and plant procedures provide operators with appropriate direction for response to a suppression pool high temperature (which could be caused by a stuck open relief valve). Providing specific direction to close the valve within two (2) minutes does not provide additional plant protection beyond what is provided for in plant procedures and TS 3.6.2.1.
Therefore, this action can be eliminated, and will not involve a significant increase in the probability or consequences of an accident previously evaluated.
2. Does the proposed change create the possibility of a new or different kind of accident from any accident previously evaluated?
The proposed TS change deletes Action Statement 3.4.2.1.b concerning safety/relief valves and revises TS Action Statement 3.6.2.1.b to be consistent with the BWR Standard Technical Specifications (NUREG-1433, “Standard Technical Specifications General Electric Plants, BWR/4,” Revision 4, dated April 2012). This change does not change the design or configuration of the plant. No new operation or failure modes are created, nor is a system-level failure mode created that is different than those that already exist.
Therefore, it is concluded that this change does not create the possibility of a new or different kind of accident from any accident previously evaluated.
3. Do the proposed changes involve a significant reduction in a margin of safety?
The proposed change does not involve a significant reduction in a margin of safety, nor does it affect any analytical limits. There are no changes to accident or transient core thermal hydraulic conditions, or fuel or reactor coolant boundary design limits, as a result of the proposed change. The proposed change will not alter the assumptions or results of the analysis contained in the Updated Final Safety Analysis Report (UFSAR).
Therefore, it is concluded that the proposed change does not involve a significant reduction in a margin of safety.
The NRC staff has reviewed the licensee's analysis and, based on this review, it appears that the three standards of 10 CFR 50.92(c) are satisfied. Therefore, the NRC staff proposes to determine that the amendment request involves no significant hazards consideration.
1. Does the proposed amendment involve a significant increase in the probability or consequences of an accident previously evaluated?
The requested action is a one-time extension to the performance interval of a limited number of TS surveillance requirements. The performance of these surveillances, or the extension of these surveillances, is not a precursor to an accident. Performing these surveillances or failing to perform these surveillances does not affect the probability of an accident. Therefore, the proposed delay in performance of the SRs in this amendment request does not increase the probability of an accident previously evaluated.
A delay in performing these surveillances does not result in a system being unable to perform its required function. In the case of this one-time extension request, the short period of additional time that the systems and components will be in service before the next performance of the surveillance will not affect the ability of those systems to operate as designed. Therefore, the systems required to mitigate accidents will remain capable of performing their required function. No new failure modes have been introduced because of this action and the consequences remain consistent with previously evaluated accidents. On this basis, the proposed delay in performance of the SRs in this amendment request does not involve a significant increase in the consequences of an accident.
Therefore, the proposed change does not involve a significant increase in the
2. Does the proposed amendment create the possibility of a new or different kind of accident from any previously evaluated?
The proposed amendment does not involve a physical alteration of any system, structure, or component (SSC) or a change in the way any SSC is operated. The proposed amendment does not involve operation of any SSCs in a manner or configuration different from those previously recognized or evaluated. No new failure mechanisms will be introduced by the one-time SR extensions being requested.
Therefore, the proposed change does not create the possibility of a new or different kind of accident from any accident previously evaluated.
3. Does the proposed amendment involve a significant reduction in a margin of safety?
The proposed amendment is a one-time extension of the performance interval of a limited number of TS surveillance requirements. Extending these surveillance requirements does not involve a modification of any TS limiting conditions for operation. Extending these SRs does not involve a change to any limit on accident consequences specified in the license or regulations. Extending these SRs does not involve a change in how accidents are mitigated or a significant increase in the consequences of an accident. Extending these SRs does not involve a change in a methodology used to evaluate consequences of an accident. Extending these SRs does not involve a change in any operating procedure or process.
The instrumentation and components involved in this request have exhibited reliable operation based on current test results. The current testing includes power ascension testing and surveillance testing that either partially or fully exercised the components. Some components have been evaluated for extended testing intervals greater than 18 months but are set at WBN to an 18-month frequency.
Based on the limited additional period of time that the systems and components will be in service before the surveillances are next performed, as well as the operating experience that these surveillances are typically successful when performed, it is reasonable to conclude that the margins of safety associated with these SRs will not be affected by the requested extension.
Therefore, the proposed change does not involve a significant reduction in a margin of safety.
The NRC staff has reviewed the licensee's analysis and, based on this review, it appears that the three standards of 50.92(c) are satisfied. Therefore, the NRC staff proposes to determine that the amendment request involves no significant hazards consideration.
During the period since publication of the last biweekly notice, the Commission has issued the following amendments. The Commission has determined for each of these amendments that the application complies with the standards and requirements of the Atomic Energy Act of 1954, as amended (the Act), and the Commission's rules and regulations. The Commission has made appropriate findings as required by the Act and the Commission's rules and regulations in 10 CFR Chapter I, which are set forth in the license amendment.
A notice of consideration of issuance of amendment to facility operating license or combined license, as applicable, proposed no significant hazards consideration determination, and opportunity for a hearing in connection with these actions, was published in the
Unless otherwise indicated, the Commission has determined that these amendments satisfy the criteria for categorical exclusion in accordance with 10 CFR 51.22. Therefore, pursuant to 10 CFR 51.22(b), no environmental impact statement or environmental assessment need be prepared for these amendments. If the Commission has prepared an environmental assessment under the special circumstances provision in 10 CFR 51.22(b) and has made a determination based on that assessment, it is so indicated.
For further details with respect to the action see (1) the applications for amendment, (2) the amendment, and (3) the Commission's related letter, Safety Evaluation and/or Environmental Assessment as indicated. All of these items can be accessed as described in the “Obtaining Information and Submitting Comments” section of this document.
The Commission's related evaluation of the amendment is contained in a Safety Evaluation dated December 22, 2016.
The Commission's related evaluation of the amendment is contained in a Safety Evaluation dated December 29, 2016.
The Commission's related evaluation of the amendments is contained in a Safety Evaluation dated December 29, 2016.
The Commission's related evaluation of the amendments is contained in a Safety Evaluation dated December 21, 2016.
The Commission's related evaluation of the amendment is contained in a Safety Evaluation dated December 21, 2016.
The Commission's related evaluation of the amendment is contained in a Safety Evaluation dated December 20, 2016.
During the period since publication of the last biweekly notice, the Commission has issued the following amendments. The Commission has determined for each of these amendments that the application for the amendment complies with the standards and requirements of the Atomic Energy Act of 1954, as amended (the Act), and the Commission's rules and regulations. The Commission has made appropriate findings as required by the Act and the Commission's rules and regulations in 10 CFR Chapter I, which are set forth in the license amendment.
Because of exigent or emergency circumstances associated with the date the amendment was needed, there was not time for the Commission to publish, for public comment before issuance, its usual notice of consideration of issuance of amendment, proposed no significant hazards consideration determination, and opportunity for a hearing.
For exigent circumstances, the Commission has either issued a
In circumstances where failure to act in a timely way would have resulted, for example, in derating or shutdown of a nuclear power plant or in prevention of either resumption of operation or of increase in power output up to the plant's licensed power level, the Commission may not have had an opportunity to provide for public comment on its no significant hazards consideration determination. In such case, the license amendment has been issued without opportunity for comment. If there has been some time for public comment but less than 30 days, the Commission may provide an opportunity for public comment. If comments have been requested, it is so stated. In either event, the State has been consulted by telephone whenever possible.
Under its regulations, the Commission may issue and make an amendment immediately effective, notwithstanding the pendency before it of a request for a hearing from any person, in advance of the holding and completion of any required hearing, where it has determined that no significant hazards consideration is involved.
The Commission has applied the standards of 10 CFR 50.92 and has made a final determination that the amendment involves no significant hazards consideration. The basis for this determination is contained in the documents related to this action. Accordingly, the amendments have been issued and made effective as indicated.
Unless otherwise indicated, the Commission has determined that these amendments satisfy the criteria for categorical exclusion in accordance with 10 CFR 51.22. Therefore, pursuant to 10 CFR 51.22(b), no environmental impact statement or environmental assessment need be prepared for these amendments. If the Commission has prepared an environmental assessment under the special circumstances provision in 10 CFR 51.12(b) and has made a determination based on that assessment, it is so indicated.
For further details with respect to the action see (1) the application for amendment, (2) the amendment to Facility Operating License or Combined License, as applicable, and (3) the Commission's related letter, Safety Evaluation and/or Environmental Assessment, as indicated. All of these items can be accessed as described in the “Obtaining Information and Submitting Comments” section of this document.
The Commission is also offering an opportunity for a hearing with respect to the issuance of the amendment.
Within 60 days after the date of publication of this notice, any persons (petitioner) whose interest may be affected by this action may file a request for a hearing and petition for leave to intervene (petition) with respect to the action. Petitions shall be filed in accordance with the Commission's “Agency Rules of Practice and Procedure” in 10 CFR part 2. Interested persons should consult a current copy of 10 CFR 2.309. The NRC's regulations are accessible electronically from the NRC Library on the NRC's Web site at
As required by 10 CFR 2.309(d) the petition should specifically explain the reasons why intervention should be permitted with particular reference to the following general requirements for standing: (1) The name, address, and telephone number of the petitioner; (2) the nature of the petitioner's right under the Act to be made a party to the proceeding; (3) the nature and extent of the petitioner's property, financial, or other interest in the proceeding; and (4) the possible effect of any decision or order which may be entered in the proceeding on the petitioner's interest.
In accordance with 10 CFR 2.309(f), the petition must also set forth the specific contentions which the petitioner seeks to have litigated in the proceeding. Each contention must consist of a specific statement of the issue of law or fact to be raised or controverted. In addition, the petitioner must provide a brief explanation of the bases for the contention and a concise statement of the alleged facts or expert opinion which support the contention and on which the petitioner intends to rely in proving the contention at the hearing. The petitioner must also provide references to the specific sources and documents on which the petitioner intends to rely to support its position on the issue. The petition must include sufficient information to show that a genuine dispute exists with the applicant or licensee on a material issue of law or fact. Contentions must be limited to matters within the scope of the proceeding. The contention must be one which, if proven, would entitle the petitioner to relief. A petitioner who fails to satisfy the requirements at 10 CFR 2.309(f) with respect to at least one contention will not be permitted to participate as a party.
Those permitted to intervene become parties to the proceeding, subject to any limitations in the order granting leave to intervene. Parties have the opportunity to participate fully in the conduct of the hearing with respect to resolution of that party's admitted contentions, including the opportunity to present evidence, consistent with the NRC's regulations, policies, and procedures.
Petitions must be filed no later than 60 days from the date of publication of this notice. Petitions and motions for leave to file new or amended contentions that are filed after the deadline will not be entertained absent a determination by the presiding officer that the filing demonstrates good cause by satisfying the three factors in 10 CFR 2.309(c)(1)(i) through (iii). The petition must be filed in accordance with the filing instructions in the “Electronic Submissions (E-Filing)” section of this document.
If a hearing is requested, and the Commission has not made a final determination on the issue of no significant hazards consideration, the Commission will make a final determination on the issue of no significant hazards consideration. The final determination will serve to establish when the hearing is held. If the final determination is that the amendment request involves no significant hazards consideration, the Commission may issue the amendment and make it immediately effective, notwithstanding the request for a hearing. Any hearing would take place after issuance of the amendment. If the final determination is that the amendment request involves a significant hazards consideration, then any hearing held would take place before the issuance of the amendment unless the Commission finds an imminent danger to the health or safety of the public, in which case it will issue an appropriate order or rule under 10 CFR part 2.
A State, local governmental body, Federally-recognized Indian Tribe, or agency thereof, may submit a petition to the Commission to participate as a party under 10 CFR 2.309(h)(1). The petition should state the nature and extent of the petitioner's interest in the proceeding. The petition should be submitted to the Commission by March 20, 2017. The petition must be filed in accordance with the filing instructions in the “Electronic Submissions (E-Filing)” section of this document, and should meet the requirements for petitions set forth in this section, except that under 10 CFR 2.309(h)(2) a State, local governmental body, or federally recognized Indian Tribe, or agency thereof does not need to address the standing requirements in 10 CFR 2.309(d) if the facility is located within its boundaries. Alternatively, a State, local governmental body, Federally-recognized Indian Tribe, or agency thereof may participate as a non-party under 10 CFR 2.315(c).
If a hearing is granted, any person who is not a party to the proceeding and is not affiliated with or represented by a party may, at the discretion of the presiding officer, be permitted to make a limited appearance pursuant to the provisions of 10 CFR 2.315(a). A person making a limited appearance may make an oral or written statement of his or her position on the issues but may not otherwise participate in the proceeding. A limited appearance may be made at any session of the hearing or at any prehearing conference, subject to the limits and conditions as may be imposed by the presiding officer. Details regarding the opportunity to make a limited appearance will be provided by the presiding officer if such sessions are scheduled.
All documents filed in NRC adjudicatory proceedings, including a request for hearing and petition for leave to intervene (petition), any motion or other document filed in the proceeding prior to the submission of a request for hearing or petition to intervene, and documents filed by interested governmental entities that request to participate under 10 CFR 2.315(c), must be filed in accordance with the NRC's E-Filing rule (72 FR 49139; August 28, 2007, as amended at 77 FR 46562, August 3, 2012). The E-Filing process requires participants to submit and serve all adjudicatory documents over the internet, or in some cases to mail copies on electronic storage media. Detailed guidance on making electronic submissions may be found in the Guidance for Electronic Submissions to the NRC and on the NRC Web site at
To comply with the procedural requirements of E-Filing, at least 10 days prior to the filing deadline, the participant should contact the Office of the Secretary by email at
Information about applying for a digital ID certificate is available on the NRC's public Web site at
A person filing electronically using the NRC's adjudicatory E-Filing system may seek assistance by contacting the NRC's Electronic Filing Help Desk through the “Contact Us” link located on the NRC's public Web site at
Participants who believe that they have a good cause for not submitting
Documents submitted in adjudicatory proceedings will appear in the NRC's electronic hearing docket which is available to the public at
The Commission will issue a notice or order granting or denying a hearing request or intervention petition, designating the issues for any hearing that will be held and designating the Presiding Officer. A notice granting a hearing will be published in the
For further details with respect to these license amendment applications, see the application for amendment which is available for public inspection in ADAMS and at the NRC's PDR. For additional direction on accessing information related to this document, see the “Obtaining Information and Submitting Comments” section of this document.
The Commission's related evaluation of the amendment, finding of emergency circumstances, state consultation, and final NSHC determination are contained in a safety evaluation dated December 23, 2016.
Public notice of the proposed amendment was published in
The Commission's related evaluation of the amendment, finding of exigent circumstances, state consultation, public comments, and final NSHC determination are contained in a safety evaluation dated December 21, 2016.
For the Nuclear Regulatory Commission.
Nuclear Regulatory Commission.
Source protection; public meetings and request for comment; correction.
The U.S. Nuclear Regulatory Commission (NRC) is correcting a notice that was published in the
The correction is effective January 17, 2017.
Please refer to Docket ID NRC-2016-0276 when contacting the NRC about the availability of information regarding this document. You may obtain publicly-available information related to this document using any of the following methods:
•
•
•
Irene Wu, Office of Nuclear Material Safety and Safeguards, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001; telephone: 301-415-1951; email:
In the FR on January 9, 2017, in FR Doc. 2017-00169, on page 2402, in the first column, the second sentence under the heading “IV. Public Comments Process,” is corrected to read as follows: “Responses to this solicitation will inform staff consideration of the regulatory impacts for any recommendations related to Category 3 source security and accountability, which will be documented in a paper to be provided to the Commission in August 2017.”
For the Nuclear Regulatory Commission.
Notice of public webinars.
The National Nanotechnology Coordination Office (NNCO), on behalf of the Nanoscale Science, Engineering, and Technology (NSET) Subcommittee of the Committee on Technology, National Science and Technology Council (NSTC), will hold one or more webinars to share information with the general public and the nanotechnology research and development community. Topics covered may include technical subjects; environmental, health, and safety issues; business case studies; or other areas of potential interest to the nanotechnology community.
The NNCO will hold one or more webinars between the publication of this Notice and December 31, 2017. The first webinar will be held on or after January 18, 2017.
For information about upcoming webinars, please visit
For information regarding this Notice, please contact Stacey Standridge at National Nanotechnology Coordination Office, by telephone (703-292-8103) or email (
Securities and Exchange Commission (“Commission”).
Notice of application for an exemptive order under Section 206A of the Investment Advisers Act of 1940
Brown Advisory LLC (“Applicant” or “Adviser”).
Exemption requested under section 206A of the Advisers Act and rule 206(4)-5(e) from rule 206(4)-5(a)(1) under the Advisers Act.
Applicant requests that the Commission issue an order under section 206A of the Advisers Act and rule 206(4)-5(e) exempting it from rule 206(4)-5(a)(1) under the Advisers Act to permit Applicant to receive compensation from certain government entities for investment advisory services provided to the government entities within the two-year period following a contribution by a covered associate of the Applicant to an official of the government entities.
The application was filed on July 18, 2016, and an amended and restated application was filed on November 22, 2016.
An order granting the application will be issued unless the Commission orders a hearing. Interested persons may request a hearing by writing to the Commission's Secretary and serving Applicant with a copy of the request, personally or by mail. Hearing requests should be received by the Commission by 5:30 p.m. on February 6, 2017, and should be accompanied by proof of service on Applicant, in the form of an affidavit or, for lawyers, a certificate of service. Pursuant to rule 0-5 under the Advisers Act, hearing requests should state the nature of the writer's interest, any facts bearing upon the desirability of a hearing on the matter, the reason for the request, and the issues contested. Persons may request notification of a hearing by writing to the Commission's Secretary.
Secretary, Securities and Exchange Commission, 100 F Street NE., Washington, DC 20549-1090. Applicant: Brown Advisory LLC, 901 South Bond Street, Suite 400, Baltimore, MD 21231.
Vanessa M. Meeks, Senior Counsel, or Parisa Haghshenas, Branch Chief, at (202) 551-6825 (Division of Investment Management, Chief Counsel's Office).
The following is a summary of the application. The complete application may be obtained via the Commission's Web site at
1. Applicant is a Maryland limited liability company registered with the Commission as an investment adviser under the Advisers Act. Applicant provides discretionary investment advisory services to individuals and institutions.
2. The individual who made the campaign contribution that triggered the two-year compensation ban (the “Contribution”) is Douglas Godine (the “Contributor”). The Contributor is the head of business development for the Adviser's private client team and has been with the Adviser for five years. The Contributor's role focuses on oversight of business development for the private client and Outsourced Chief Investment Officer (“OCIO”) teams. Applicant submits that, because the Contributor, in his OCIO role, oversees business development activities related to clients that may include entities covered by Rule 206(4)-5(f)(5), he is a covered associate as defined by Rule 206(4)-5(f)(2)(ii).
3. Seven of the Adviser's clients are agencies, authorities, or instrumentalities of the State of Maryland (the “Clients”). The Clients are government entities as defined in Rule 206(4)-5(f)(5)(i).
4. The recipient of the Contribution was Larry Hogan (the “Candidate”), who, at the time of the Contribution was the governor-elect of Maryland, and at the time of this Application is Maryland's Governor. The Maryland Governor is the chief executive of the state and can influence investment decisions, including the hiring of an investment adviser, for the state and for other entities that are overseen by boards composed of individuals appointed by the Maryland Governor (“Gubernatorial Appointees”). Due to his office and the power of appointment, the Maryland Governor is an “official” of the Clients as defined in Rule 206(4)-5(f)(6)(ii). None of the Gubernatorial Appointees serving at the time of the Contribution were appointed by the Candidate, who had not yet taken office.
5. The Contribution that triggered rule 206(4)-5's prohibition on compensation under rule 206(4)-5(a)(1) was recorded on January 12, 2015, for the amount of $1,000 made out to “Larry Hogan for Governor.” Applicant submits that the contribution was made by the Contributor for purely personal reasons, separate and apart from the Contributor's role with the Adviser. The Contribution was made at the request of a family friend with whom the Contributor has been friends for about a decade. The Contributor and his friend are active together in their local sports community, and they have been active participants together in their children's sports teams. In the past, the Contributor has provided support for other causes at the request of the friend, including monetary support. The friend invited the Contributor to a dinner at a restaurant in Annapolis for members of the local community. Applicant submits that the Contributor was unaware the event was a fundraiser for the Candidate until he attended the event, and that the Contributor had no prior contact, affiliation with, or intention to contribute to the Candidate. Applicant represents that the Contributor did not seek out or initiate contact with the Candidate and that he was briefly introduced to the Candidate at the event, but at no time was there any mention of the Adviser or the Clients.
6. The Clients' decisions to invest with the Adviser occurred long before the Candidate commenced his campaign for office in January 2014, before the Candidate was elected in November 2014, and before the Contribution was made in January 2015. The earliest of the Clients made a commitment to invest with the Adviser in 2004, and the most recent Client did so in 2012. Applicant represents that none of the Clients have materially increased the amounts of assets managed by the Adviser, initiated new investment mandates, or opened new accounts with the Adviser since the Contribution was made. The Contributor has had no interaction with the Clients, with any representative of the Clients, or with the Clients' boards.
7. The Adviser became aware of the Contribution when it conducted a check of campaign contribution disclosures on June 8, 2016. Within one week, the Contributor requested the return of the full Contribution from the Candidate. This request was granted and a check refunding the full Contribution was received on July 15, 2016. After identifying the Contribution, the Adviser took steps beginning on June 8, 2016 to establish an escrow account, and the Adviser has deposited an amount equal to the sum of all fees paid to the Adviser and its affiliates, directly or indirectly, with respect to the Clients since the date of the Contribution, January 12, 2015. Additional fees or other compensation accruing in favor of the Adviser and its affiliates will continue to be deposited into the escrow account or will not be collected from the Clients until it is determined whether exemptive relief will be granted to the Adviser.
8. The Applicant's Political Contributions Policy (the “Policy”) was adopted and published in January 2011, before Rule 206(4)-5's compliance date and long before the Contribution was made. All contributions by employees to federal, state, and local office incumbents and candidates are subject to pre-clearance, not post-contribution reporting, under the Policy. There is no
1. Rule 206(4)-5(a)(1) under the Advisers Act prohibits a registered investment adviser from providing investment advisory services for compensation to a government entity within two years after a contribution to an official of the government entity is made by the investment adviser or any covered associate of the investment adviser. Each of the Clients is a “government entity,” as defined in rule 206(4)-5(f)(5), the Contributor is a “covered associate” as defined in rule 206(4)-5(f)(2), and the Candidate is an “official” as defined in rule 206(4)-5(f)(6).
2. Section 206A of the Advisers Act grants the Commission the authority to “conditionally or unconditionally exempt any person or transaction . . . from any provision or provisions of [the Advisers Act] or of any rule or regulation thereunder, if and to the extent that such exemption is necessary or appropriate in the public interest and consistent with the protection of investors and the purposes fairly intended by the policy and provisions of [the Advisers Act].”
3. Rule 206(4)-5(e) provides that the Commission may exempt an investment adviser from the prohibition under Rule 206(4)-5(a)(1) upon consideration of the factors listed below, among others:
(1) Whether the exemption is necessary or appropriate in the public interest and consistent with the protection of investors and the purposes fairly intended by the policy and provisions of the Advisers Act;
(2)
(3) Whether, at the time of the contribution, the contributor was a covered associate or otherwise an employee of the investment adviser, or was seeking such employment;
(4) The timing and amount of the contribution which resulted in the prohibition;
(5) The nature of the election (
(6) The contributor's apparent intent or motive in making the contribution which resulted in the prohibition, as evidenced by the facts and circumstances surrounding such contribution.
4. Applicant requests an order pursuant to section 206A and rule 206(4)-5(e), exempting it from the two-year prohibition on compensation imposed by rule 206(4)-5(a)(1) with respect to investment advisory services provided to the Clients within the two-year period following the Contribution.
5. Applicant submits that the exemption is necessary and appropriate in the public interest and consistent with the protection of investors and the purposes fairly intended by the policy and provisions of the Advisers Act. Applicant further submits that the other factors set forth in rule 206(4)-5(e) similarly weigh in favor of granting an exemption to the Applicant to avoid consequences disproportionate to the violation.
6. Applicant contends that given the nature of the Rule violation, and the lack of any evidence that the Adviser or the Contributor intended to, or actually did, interfere with any client's merit-based process for the selection or retention of advisory services, the interests of the Clients are best served by allowing the Adviser and its Clients to continue their relationship uninterrupted. Applicant states that causing the Adviser to serve without compensation for a two-year period could result in a financial loss that is more than 1,949 times the amount of the Contribution that exceeded the
7. Applicant represents the Policy was adopted and published in January 2011, before the Rule's compliance date and long before the Contribution was made. Applicant further represents that, at all times, the Policy has conformed to the requirements of the Rule and has been even broader than what was contemplated by the Rule. Both before and after the Rule's compliance date, the Adviser has conducted a series of compliance training sessions that addressed the Policy, including reiterating the need to pre-clear all political contributions, together with an annual policy compliance attestation by all employees. The compliance testing conducted by the Adviser includes periodic searches of campaign contribution databases for the names of employees, such as the search that identified the Contribution.
8. Applicant asserts that at no time did any employee of the Adviser other than the Contributor have any knowledge that the Contribution had been made before its discovery by the Adviser in June 2016.
9. Applicant asserts that after learning of the Contribution, the Adviser and the Contributor promptly took steps to obtain a return of the Contribution and to implement additional measures to prevent future error, including providing supplemental training to all employees on the Policy to ensure that other employees fully understand the Policy and do not make the same mistake as the Contributor.
10. Applicant states that after learning of the Contribution, it confirmed that the Contributor had no contact with any representative of the Clients and will have no contact with any representative of the Clients for the duration of the two-year period beginning January 12, 2015.
11. Applicant asserts that the Clients' decisions to invest with the Adviser occurred long before the Candidate commenced his campaign for office in January 2014, before the Candidate was elected in November 2014, and before the Contribution was made in January 2015. Applicant states that, at the time of the Contribution, the Candidate had not exercised or even obtained the appointment power reserved to his State office. The Contributor is a longtime Maryland resident and voter, and
12. Applicant submits that neither the Adviser nor the Contributor sought to interfere with the Clients' merit-based selection process for advisory services, nor did they seek to negotiate higher fees or greater ancillary benefits than would be achieved in arms' length transactions. Applicant further submits that there was no violation of the Adviser's fiduciary duty to deal fairly or disclose material conflicts given the absence of any intent or action by the Adviser or the Contributor to influence the selection process. Applicant contends that in the case of the Contribution, imposition of the two-year prohibition on compensation does not achieve the Rule's purposes and would result in consequences disproportionate to the mistake that was made.
The Applicant agrees that any order of the Commission granting the requested relief will be subject to the following conditions:
1. The Contributor will be prohibited from discussing the business of the Applicant with any “government entity” client for which the Official is an “official,” each as defined in Rule 206(4)-5(f), until January 12, 2017.
2. The Contributor will receive a written notification of the conditions and will provide a quarterly certificate of compliance until January 12, 2017. Copies of the certifications will be maintained and preserved in an easily accessible place for a period of not less than five years, the first two years in an appropriate office of the Applicant, and be available for inspection by the staff of the Commission.
3. The Applicant will conduct testing reasonably designed to prevent violations of the conditions of the Order and maintain records regarding such testing, which will be maintained and preserved in an easily accessible place for a period of not less than five years, the first two years in an appropriate office of the Applicant, and be available for inspection by the staff of the Commission.
For the Commission, by the Division of Investment Management, under delegated authority.
Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (“Act”)
The Exchange filed a proposal to modify the Fee Schedule applicable to the Exchange's options platform (“EDGX Options”) to adopt fees for its recently adopted Bats Auction Mechanism (“BAM”, “BAM Auction”, or “Auction”).
The text of the proposed rule change is available at the Exchange's Web site at
In its filing with the Commission, the Exchange included statements concerning the purpose of and basis for the proposed rule change and discussed any comments it received on the proposed rule change. The text of these statements may be examined at the places specified in Item IV below. The Exchange has prepared summaries, set forth in Sections A, B, and C below, of the most significant parts of such statements.
The Exchange proposes to modify the Fee Schedule applicable to the Exchange's options platform (“EDGX Options”) to adopt fees for its recently adopted Bats Auction Mechanism (“BAM”, “BAM Auction”, or “Auction”). BAM includes functionality in which a Member (an “Initiating Member”) may electronically submit for execution an order it represents as agent on behalf of a Priority Customer,
As additional background for the fees described below, the Exchange notes that any person or entity other than the Initiating Member may submit responses to an Auction. A BAM Auction takes into account responses to the Auction as well as interest resting on the Exchange's order book at the conclusion of the auction (“unrelated orders”), regardless of whether such unrelated orders were already present on the Exchange's order book when the Agency Order was received by the Exchange or were received after the Exchange commenced the applicable Auction. If contracts remain from one or more unrelated orders at the time the Auction ends, they will be considered for participation in the BAM order allocation process.
In connection with the fee proposal, the Exchange proposes to adopt definitions necessary for BAM pricing. First, the Exchange proposes to adopt defined terms of “BAM” and “BAM Auction” to refer to Auctions on the Fee Schedule. Second, the Exchange proposes to adopt the defined term “BAM Agency Order”, which would be
The Exchange proposes to adopt six new fee codes in connection with BAM, which would be added to the Fee Codes and Associated Fees table of the Fee Schedule. These fee codes represent the fees applicable to BAM, as described below. In addition, the Exchange proposes to adopt new footnote 6, which would again summarize BAM fees and rebates in a table form, would provide additional details regarding the applicability of such fees and rebates, and would include a provision regarding BAM Break-Up Credits.
The Exchange proposes to adopt two fee codes for BAM Agency Orders, fee code BA and fee code BC, which would be applicable to Non-Customer
Next, the Exchange proposes to adopt fee code BB, which would apply to a BAM Contra Order executed in an Auction and would be charged a fee of $0.04 per contract.
The Exchange also proposes to adopt fee codes BD and BE, which would apply to BAM Responder Orders in Penny Pilot Securities
Finally, the Exchange proposes to adopt fee code CC for all executions in a BAM Customer-to-Customer Immediate Cross. As proposed, all executions yielding fee code CC would be provided free of charge.
As discussed above, in addition to setting forth the proposed fees and rebates in the Fee Codes and Associated Fees table, the Exchange proposes to adopt footnote 6 to again summarize BAM fees and rebates in a table form that is organized differently in order to provide clarity to Users.
The proposed table would horizontally categorize the types of orders that could be executed within BAM, namely “Agency” (
The Exchange also proposes to make clear with respect to BAM Agency Orders that when a BAM Agency Order executes against one or more resting orders that were already on the Exchange's order book when the BAM Agency Order was received by the Exchange, the BAM Agency Order and the resting order(s) would receive the Standard Fee Rates. Specifically, and as described above, it is possible for unrelated interest that is already present on the Exchange's order book when a BAM Agency Order is received to be included in an Auction. As proposed, footnote 6 will make clear that this will not alter the fee structure for such execution and instead the Exchange will charge a fee or provide a rebate to each side of the transaction as if it were a transaction occurring on the Exchange's order book pursuant to the Exchange's normal order handling methodology and not in BAM. This stands in contrast to BAM Responder Orders, which, as defined, include unrelated orders that are received by the Exchange after a BAM Auction has begun and which would be charged or provided rebates based specifically on BAM pricing.
The Exchange also proposes to make clear with respect to Customer orders that such orders will be charged or provided rebates based on the proposed pricing for BAM (
In addition, the Exchange proposes to adopt under footnote 6 BAM Break-Up Credits. As proposed, the Exchange will apply a BAM Break-Up Credit to the Member that submitted a BAM Agency Order, including a Member who routed an order to the Exchange with a Designated Give Up (as described in further detail below), when the BAM Agency Order trades with a BAM Responder Order. As proposed, the BAM Break-Up Credit provided with respect to a BAM Auction in a Penny Pilot Security would be $0.25 per contract and the BAM Break-Up Credit provided with respect to a BAM Auction in a Non-Penny Pilot Security would be $0.60 per contract.
In order to encourage the use of BAM, the Exchange proposes to adopt new tiers under footnotes 1 and 2 of the Fee Schedule, which are similar to existing tiers but with an enhanced rebated to incentivize the submission of BAM Agency Orders.
Fee codes PC and NC are currently appended to all Customer orders in Penny Pilot Securities and Non-Penny Pilot Securities, respectively, and result in a standard rebate of $0.05 per contract. Instead of the standard rebate provided to Customer orders, Members are able to receive enhanced rebates for Customer orders to the extent they satisfy monthly volume criteria. The Exchange currently offers five Customer Volume Tiers pursuant to footnote 1. For instance, pursuant to Customer Volume Tier 5, a Member will receive an enhanced rebate of $0.21 per contract where the Member has an ADV
Fee codes PM and NM are currently appended to all Market Maker orders in Penny Pilot Securities and Non-Penny Pilot Securities, respectively, and result in a standard fee of $0.19 per contract. The Market Maker Volume Tiers in footnote 2 consist of seven separate tiers, each providing a reduced fee or rebate to a Member's Market Maker orders that yield fee codes PM or NM upon satisfying the monthly volume criteria required by the respective tier. For instance, pursuant to Market Maker Volume Tier 7, a Member will be charged a reduced fee of $0.03 per contract where the Member has: (i) Customer orders equal to or greater than 0.05% of average OCV; and (ii) Customer or Market Maker orders equal to or greater than 0.35% of average OCV. To encourage the entry of BAM Agency Orders to the Exchange, the Exchange proposes to adopt Market Maker Volume Tier 8, which would be identical to Tier 7 but would instead provide a reduced fee of $0.02 per contract for Market Maker orders to the extent a Member also has an ADV in BAM Agency Orders equal to or greater than 1 contract (in addition to the volume criteria described above with respect to Tier 7).
Footnote 5 of the Fee Schedule currently specifies that when order is submitted with a Designated Give Up, as defined in Rule 21.12(b)(1), the applicable rebates for such orders when executed on the Exchange (yielding fee code NC or PC)
In connection with the adoption of fees applicable to BAM, the Exchange proposes to add new fee code BC to the lead-in sentence of footnote 5 and to append footnote 5 to fee code BC in the Fee Codes and Associated Fees table of the Fee Schedule. In addition, the Exchange proposes to include reference to Routing Firms (
The Exchange proposes to implement the proposed changes immediately.
The Exchange believes that the proposed rule change is consistent with the requirements of the Act and the rules and regulations thereunder that are applicable to a national securities exchange, and, in particular, with the requirements of Section 6 of the Act.
The Exchange's proposal establishes fees and rebates regarding BAM, which promotes price improvement to the benefit of market participants. The Exchange believes that BAM will encourage market participants, and in particular liquidity providers on the Exchange, to compete vigorously to provide opportunities for price improvement in a competitive auction process. The Exchange believes that its proposal will allow the Exchange to recoup the costs associated with BAM while also incentivizing its use.
The Exchange is adopting the proposed fees and rebates at this time because it believes that the associated revenue will allow it to promote and maintain BAM, which is beneficial to market participants.
In sum, the Exchange believes that the proposed fee and rebate structure is designed to promote BAM and, in particular, to attract Customer liquidity, which benefits all market participants by providing additional trading opportunities. This attracts liquidity providers and an increase in the activity of these market participants in turn facilitates tighter spreads, which may cause an additional corresponding increase in order flow originating from other market participants.
Moreover, the Exchange believes that charging market participants, other than Customers, a higher effective rate for certain BAM transactions is reasonable, equitable, and not unfairly discriminatory because these types of market participants are more
With respect to the proposal to adopt a rebate for Customer BAM Agency Orders ($0.14 per contract) and adopt fees for both Non-Customer BAM Agency Orders ($0.20 per contract) and all BAM Contra Orders ($0.04 per contract), the Exchange believes this is reasonable because it encourages participation in BAM by offering rates that are equivalent to or better than most other price improvement auctions offered by other options exchanges.
Providing Customers a rebate for BAM Agency Orders, while assessing Non-Customers a fee for BAM Agency Orders, is reasonable because of the desirability of Customer activity. The proposed new fees and rebates for BAM are generally intended to encourage greater Customer trade volume to the Exchange. Customer activity enhances liquidity on the Exchange for the benefit of all market participants and benefits all market participants by providing more trading opportunities, which attracts market makers and other liquidity providers. An increase in the activity of these market participants in turn facilitates tighter spreads, which may cause an additional corresponding increase in order flow from other market participants. The practice of incentivizing increased Customer order flow through a fee and rebate schedule in order to attract professional liquidity providers is, and has been, commonly practiced in the options markets, and the Exchange.
The proposed fee and rebate schedule is reasonably designed because it is within the range of fees and rebates assessed by other exchanges employing similar fee structures for price improvement mechanisms.
The fee and rebate schedule as proposed continues to reflect differentiation among different market participants typically found in options fee and rebate schedules.
With respect to the Customer-to-Customer Immediate Cross, establishing no Customer fee or rebate for either side of the transaction, is also reasonable, equitably allocated and not unreasonably discriminatory because it still encourages the entry of Customer orders to the Exchange while treating, from the Exchange's perspective, each side of the order neutrally rather than providing one Customer a rebate but charging another Customer a fee.
For BAM Responder Orders, establishing that there will be a $0.50 fee per contract for orders in Penny Pilot Securities and a $1.05 fee per contract for orders in Non-Penny Pilot Securities, is reasonable because the associated revenue will allow the Exchange to maintain and enhance its services. The proposed fee and rebate schedule is also reasonably designed because it is within the range of fees and rebates assessed by other exchanges employing similar fee structures for price improvement mechanisms.
For BAM Responder Orders, establishing a fee for such orders is equitable and not unfairly
The Exchange further believes its proposal represents a reasonable and equitable allocation of dues and fees in that the proposal would treat an unrelated order as well as a BAM Agency Order that executes against such order differently depending on whether the unrelated order was already resting on the Exchange's order book at the time the BAM Agency Order was received or was received after the BAM Auction had begun.
As proposed, an unrelated order would be considered a BAM Responder Order if received after the BAM Auction had commenced. As a result, both the BAM Agency Order executing against such order and such order itself would be assessed fees and provided rebates according to the proposed BAM pricing. The Exchange believes this is a reasonable and equitable allocation of dues and fees, and is not unreasonably discriminatory, because it ensures that market participants are treated similarly with respect to their executions against BAM Agency Orders. To do otherwise, to the extent fees are higher pursuant to BAM pricing than under the Exchange's Standard Fee Rates, would incentivize a market participant that wishes to participate in an Auction to nonetheless avoid sending orders to the Exchange that are not targeted towards the Auction and instead send orders to the Exchange's order book generally, knowing that such orders would be considered in the Auction anyway.
In contrast, as proposed, to the extent an unrelated order was already present on the Exchange's order book when a BAM Agency Order is received, such unrelated order, if executed in an Auction, as well as the BAM Agency Order against which it trades will be charged a fee or provided a rebate as if the transaction occurred on the Exchange's order book pursuant to the Exchange's normal order handling methodology and not in BAM. The Exchange similarly believes this is a reasonable and equitable allocation of dues and fees, and is not unreasonably discriminatory, because it will ensure that the participant that had established position on the Exchange's order book first, the unrelated order, is not impacted with respect to applicable fees or rebates despite the later arrival of a BAM Agency Order that commences an Auction.
With respect to the proposal to adopt BAM Break-Up Credits, the Exchange believes this is reasonable because it encourages use of BAM by offering pricing that is equivalent to pricing provided pursuant to other price improvement auctions offered by other options exchanges. The proposal to offer BAM Break-Up Credits is reasonably designed because it is within the range of fees and rebates assessed by other exchanges employing similar fee structures for price improvement mechanisms.
Volume-based rebates such as those currently maintained on the Exchange have been widely adopted by options exchanges and are equitable because they are open to all Members on an equal basis and provide additional benefits or discounts that are reasonably related to the value of an exchange's market quality associated with higher levels of market activity, such as higher levels of liquidity provision and/or growth patterns, and introduction of higher volumes of orders into the price and volume discovery processes. The proposed adoption of Customer Volume Tier 6 and Market Maker Volume Tier 8, are each intended to incentivize Members to send additional Customer and Market Maker orders to the Exchange as well as to participate in the Exchange's new BAM process in an effort to qualify for the enhanced rebate or lower fee made available by the tiers.
The Exchange believes that the proposed tiers are reasonable, fair and equitable, and non-discriminatory, for the reasons set forth above with respect to volume-based pricing generally and because such changes will incentivize participants to further contribute to market quality. The proposed tiers will provide an additional way for market participants to qualify for enhanced rebates or reduced fees. Further, BAM is fully available to all Members, and the proposed threshold is intentionally low to encourage Members to do the development work necessary to participate in BAM and send BAM Agency Orders.
In connection with the adoption of fees applicable to BAM, the Exchange proposes to add new fee code BC to the lead-in sentence of footnote 5 and to append footnote 5 to fee code BC in the Fee Codes and Associated Fees table of the Fee Schedule. In addition, the Exchange proposes to include reference to Routing Firms (
The Exchange believes the proposed rebate would not impose any burden on competition that is not necessary or appropriate in furtherance of the purposes of the Act. The Exchange does not believe that the proposed rebate represents a significant departure from previous pricing offered by the Exchange or pricing offered by the Exchange's competitors. Rather, the Exchange believes the proposal will enhance competition as it is a competitive proposal that seeks to further the growth of the Exchange by encouraging Members to enter BAM Agency Orders, orders in response to BAM Agency Orders, and orders to the Exchange generally.
The Exchange's proposal to adopt BAM was a competitive response to similar price improvement auctions operated by other options exchanges.
The Exchange does not believe that the proposed rule change will impose any burden on competition not necessary or appropriate in furtherance of the purposes of the Act. Specifically, the Exchange does not believe that its proposal to establish fees and rebates for BAM will impose any burden on competition, as discussed below.
The Exchange operates in a highly competitive market in which many sophisticated and knowledgeable market participants can readily and do send order flow to competing exchanges if they deem fee levels or rebate incentives at a particular exchange to be excessive or inadequate. Additionally, new competitors have entered the market and still others are reportedly entering the market shortly. These market forces ensure that the Exchange's fees and rebates remain competitive with the fee structures at other trading platforms. In that sense, the Exchange's proposal is actually pro-competitive because the Exchange is simply establishing rebates and fees in order to remain competitive in the current environment.
The Exchange does not believe that the proposed rule change will impose any burden on competition not necessary or appropriate in furtherance of the purposes of the Act. In terms of inter-market competition, the Exchange notes that it operates in a highly competitive market in which market participants can readily favor competing venues if they deem fee levels at a particular venue to be excessive, or rebate opportunities available at other venues to be more favorable. In such an environment, the Exchange must continually adjust its fees to remain competitive with other exchanges. Because competitors are free to modify their own fees in response, and because market participants may readily adjust their order routing practices, the Exchange believes that the degree to which fee changes in this market may impose any burden on competition is extremely limited.
In this instance, the proposed charges assessed and credits available to member firms in respect of BAM do not impose a burden on competition because the Exchange's execution and routing services are completely voluntary and subject to extensive competition. If the changes proposed herein are unattractive to market participants, it is likely that the Exchange will lose market share as a result and/or will be unable to attract participants to BAM. Accordingly, the Exchange does not believe that the proposed changes will impair the ability of members or competing order execution venues to maintain their competitive standing in the financial markets. Additionally, the changes proposed herein are pro-competitive to the extent that they allow the Exchange to promote and maintain BAM, which has the potential to result in more efficient, price improved executions to the benefit of market participants.
The Exchange believes that the proposed change would increase both inter-market and intra-market competition by incentivizing members to direct their orders, and particularly Customer orders, to the Exchange, which benefits all market participants by providing more trading opportunities, which attracts market makers. To the extent that there is a differentiation between proposed fees assessed and rebates offered to Customers as opposed to other market participants, the Exchange believes that this is appropriate because the fees and rebates should incentivize members to direct additional order flow to the Exchange and thus provide additional liquidity that enhances the quality of its markets and increases the volume of contracts traded on the Exchange.
To the extent that this purpose is achieved, all the Exchange's market participants should benefit from the improved market liquidity. Enhanced market quality and increased transaction volume that results from the anticipated increase in order flow directed to the Exchange will benefit all market participants and improve competition on the Exchange. The Exchange notes that it operates in a highly competitive market in which market participants can readily favor competing venues if they deem fee levels at a particular venue to be excessive.
The Exchange believes that the proposed fees and rebates for participation in the BAM Auction are not going to have an impact on intra-market competition based on the total cost for participants to transact as respondents to the Auction as compared to the cost for participants to engage in non-Auction electronic transactions on the Exchange.
As noted above, the Exchange believes that the proposed pricing for the BAM Auction is comparable to that of other exchanges offering similar electronic price improvement mechanisms, and the Exchange believes that, based on general industry experience, market participants understand that the price-improving benefits offered by an Auction justify and offset the transaction costs associated with such Auction. To the extent that there is a difference between non-BAM transactions and BAM transactions, the Exchange does not believe this difference will cause participants to refrain from responding to BAM or submitting orders to the Exchange when a BAM Auction is underway.
In addition, the Exchange does not believe that the proposed transaction fees and credits burden competition by creating a disparity of transaction fees between the BAM Contra Order and the transaction fees a Responder pays would result in certain participants being unable to compete with the contra side order.
The Exchange expects to see robust competition within the BAM Auction. As discussed, the Exchange notes that it operates in a highly competitive market in which market participants can readily favor competing venues if they deem fee levels at a particular venue to be excessive. In such an environment, the Exchange must continually adjust its fees to remain competitive with other exchanges and to attract order flow to the Exchange. The Exchange believes that the proposed rule change reflects this competitive environment because it establishes a fee structure in a manner that encourages market participants to direct their order flow, to provide liquidity, and to attract additional transaction volume to the Exchange.
The Exchange has not solicited, and does not intend to solicit, comments on this proposed rule change. The Exchange has not received any written comments from members or other interested parties.
The foregoing rule change has become effective pursuant to Section 19(b)(3)(A) of the Act
Interested persons are invited to submit written data, views, and arguments concerning the foregoing, including whether the proposed rule change is consistent with the Act. Comments may be submitted by any of the following methods:
• Use the Commission's Internet comment form (
• Send an email to
• Send paper comments in triplicate to Brent J. Fields, Secretary, Securities and Exchange Commission, 100 F Street NE., Washington, DC 20549-1090.
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (“Act”),
The Exchange proposes to reduce the fees for limited partnerships listed on Nasdaq.
While these amendments are effective upon filing, the Exchange has designated the proposed amendments to be operative on January 1, 2017.
A notice of the proposed rule change for publication in the
(a)-(c) No change.
(d) The All-Inclusive Annual Listing Fee will be calculated on total shares outstanding according to the following schedules:
(1)-(3) No change.
(4) Limited Partnerships (effective January 1, 2017):
(e) No change.
IM-5920-1. All-Inclusive Annual Listing Fee
(a)-(c) No change.
(d) The All-Inclusive Annual Listing Fee will be calculated on total shares outstanding according to the following schedules:
(1)-(3) No change.
(4) Limited Partnerships (effective January 1, 2017):
(e) No change.
In its filing with the Commission, the Exchange included statements concerning the purpose of and basis for the proposed rule change and discussed any comments it received on the proposed rule change. The text of these statements may be examined at the places specified in Item IV below. The Exchange has prepared summaries, set forth in sections A, B, and C below, of the most significant aspects of such statements.
Nasdaq proposes to reduce the fees for limited partnerships listed on Nasdaq.
The proposed amendment will affect the All-Inclusive Annual Listing Fee schedule
As detailed in the proposed rule, for limited partnerships listed on the Capital Market the All-Inclusive Annual Listing Fee will range from $30,000 to $37,500. On the Global and Global Select Markets, the All-Inclusive Annual Listing Fee for limited partnerships will range from $37,500 to $77,500.
Nasdaq notes that American Depositary Receipts (ADRs) and Closed-end Funds also have different fee schedules than other listed equity securities. Nasdaq believes that the characteristics of ADRs and Closed-end Funds are different than the characteristics of limited partnerships and that it is therefore appropriate to apply a different fee schedule for limited partnerships.
The proposed fee change will be operative January 1, 2017.
Nasdaq notes that no other company will be required to pay higher fees as a result of the proposed amendments and represents that the proposed fee change will have no impact on the resources available for its regulatory programs.
The Exchange believes that its proposal is consistent with Section 6(b) of the Act,
As a preliminary matter, Nasdaq competes for listings with other national securities exchanges and companies can easily choose to list on, or transfer to, those alternative venues. As a result, the fees Nasdaq can charge listed companies are constrained by the fees charged by its competitors and Nasdaq cannot charge prices in a manner that would be unreasonable, inequitable, or unfairly discriminatory.
Nasdaq believes that the proposed fee change reducing the fee paid by limited partnerships is reasonable and not unfairly discriminatory because it recognizes the reduced regulatory cost Nasdaq incurs for limited partnerships. Specifically, certain of Nasdaq's corporate governance requirements, including most shareholder approval requirements (other than for equity compensation), most independence requirements (other than for audit committees at the general partner level), and the annual meeting requirement (unless required by statute or regulation in the state in which the limited partnership is formed or doing business or by the terms of the partnership's limited partnership agreement), do not apply to limited partnerships because their structure typically requires that public investors have limited rights and that the general partners make all significant decisions about the operation of the company. This allows Nasdaq to expend fewer resources on monitoring and enforcing its rules because a significant portion of the regulatory cost Nasdaq incurs in connection with the continued listing of an issuer relates to the review by Nasdaq staff of complex transactions for compliance with
Currently, ADRs and Closed-end Funds also pay lower All-Inclusive Annual Listing Fees than other issuers of equity securities. Nasdaq believes it is appropriate to apply a fee schedule to limited partnerships that is different from those applicable to either ADRs or Closed-end Funds due to their differing characteristics. Specifically, Nasdaq charges lower listing fees for ADRs because, among other differences, the U.S. listing is not typically the issuer of an ADR's primary listing.
While the proposed fee reduction only applies to limited partnerships on the All-Inclusive Annual Fee schedule, Nasdaq notes that any currently listed limited partnership can opt into the All-Inclusive Annual Fee schedule for 2017 prior to December 31, 2016, and that all companies will transition to that fee schedule in 2018. Moreover, Nasdaq accrues benefits from companies being on this schedule.
Finally, Nasdaq believes that the proposed fees are consistent with the investor protection objectives of Section 6(b)(5) of the Act
Nasdaq does not believe that the proposed rule change will result in any burden on competition that is not necessary or appropriate in furtherance of the purposes of the Act, as amended. The market for listing services is extremely competitive and listed companies may freely choose alternative venues based on the aggregate fees assessed, and the value provided by each listing. This rule proposal does not burden competition with other listing venues, which are similarly free to set their fees. For these reasons, Nasdaq does not believe that the proposed rule change will result in any burden on competition for listings.
No written comments were either solicited or received.
The foregoing rule change has become effective pursuant to Section 19(b)(3)(A)(ii) of the Act.
At any time within 60 days of the filing of the proposed rule change, the Commission summarily may temporarily suspend such rule change if it appears to the Commission that such action is: (i) Necessary or appropriate in the public interest; (ii) for the protection of investors; or (iii) otherwise in furtherance of the purposes of the Act. If the Commission takes such action, the Commission shall institute proceedings to determine whether the proposed rule should be approved or disapproved.
Interested persons are invited to submit written data, views, and arguments concerning the foregoing, including whether the proposed rule change is consistent with the Act. Comments may be submitted by any of the following methods:
• Use the Commission's Internet comment form (
• Send an email to
• Send paper comments in triplicate to Brent J. Fields, Secretary, Securities and Exchange Commission, 100 F Street NE., Washington, DC 20549-1090.
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
On May 3, 2016, NYSE Arca, Inc. (“NYSE Arca” or “Exchange”) filed with the Securities and Exchange Commission (“Commission”), pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (“Act”)
On June 27, 2016, pursuant to Section 19(b)(2) of the Act,
The Exchange currently lists and trades Shares of the Fund
The Fund currently seeks investment results that generally correspond to the price and yield (before fees and expenses) of The Bank of America (“BofA”) Merrill Lynch Build America Bond Index (“Build America Bond Index”). The Fund generally invests at least 80% of its total assets in taxable municipal securities eligible to participate in the Build America Bond program created under the American Recovery and Reinvestment Act of 2009 or other legislation providing for the issuance of taxable municipal securities on which the issuer receives federal support of the interest paid (“Build America Bonds”) and that comprise the Build America Bond Index. The Build America Bond Index is designed to track the performance of U.S. dollar-denominated investment grade taxable municipal debt publicly issued under the Build America Bond program by U.S. states and territories, and their political subdivisions, in the U.S. market. Qualifying securities must have a minimum amount outstanding of $1 million, at least 18 months remaining term to final maturity at the time of issuance, at least one year remaining term to final maturity, a fixed coupon schedule, and an investment grade rating (based on an average of Moody's Investors Services, Inc. (“Moody's”), Standard & Poor's, a division of The McGraw-Hill Company, Inc. (“S&P”), and Fitch Ratings, Inc. (“Fitch”)).
The Trust has proposed to change the index underlying the Fund to the BofA Merrill Lynch US Taxable Municipal Securities Plus Index (“New Index”) and to change the name of the Fund to PowerShares Taxable Municipal Bond Portfolio. The Exchange represents that the New Index does not meet the generic listing criteria of NYSE Arca Equities Rule 5.2(j)(3). The Exchange submitted this proposed rule change to permit the continued listing of the Fund. The New Index meets all of the requirements of the generic listing criteria of NYSE Arca Equities Rule 5.2(j)(3), except for that set forth in Commentary .02(a)(2).
According to the Exchange, the Fund currently has a non-fundamental policy to invest at least 80% of its net assets (plus the amount of any borrowings for investment purposes) in Build America
However, in response to a changing market environment that includes a reduction in the number of Build America Bonds, the Adviser has proposed that the Fund's underlying index be changed from one that is focused on Build America Bonds to one that is more broadly focused on taxable municipal debt in general, and which may include Build America Bonds. Changing the Fund's underlying index would require changing the non-fundamental policy set forth above. Accordingly, before the Fund can change its underlying index, the Registration Statement states that the Fund's board of trustees (“Board”) must approve the underlying index change, and the Fund must provide shareholders with sixty days written notice of the change.
Thus, after this proposed rule change is approved, the Trust represents that it intends to seek to obtain Board approval and provide the requisite shareholder notice. Subject to that Board approval and shareholder notice, the Fund intends to change its underlying index to one that is composed of taxable municipal securities, including both Build America Bonds and non-Build America Bonds. Following such change, the proposed underlying index for the Fund will be the New Index.
According to the Exchange, the change in the Fund's underlying index is designed to enable the Fund to expand its range of investments in light of a diminishing supply of Build America Bonds; otherwise, there is no other change to the Fund's investment strategies or objective. After such change, the Fund's investment objective will be to seek investment results that generally correspond (before fees and expenses) to the price and yield of the New Index. The Fund's new non-fundamental investment policy will be to invest at least 80% of its net assets (plus borrowings for investment purposes) in taxable municipal securities. In addition, the Fund generally will invest at least 80% of its total assets in the securities that will compose the New Index, in accordance with the terms of the Trust's Exemptive Order. However, the Fund may invest up to 20% of its total assets in securities not included in the New Index, money market instruments, including repurchase agreements or other funds that invest exclusively in money market instruments (subject to applicable limitations under the 1940 Act or exemptions therefrom), convertible securities and structured notes (notes on which the amount of principal repayment and interest payments is based on the movement of one or more specified factors, such as the movement of a particular security or securities index), all to the extent that the Adviser believes investment in such instruments will facilitate the Fund's ability to achieve its new investment objective. In addition, the Fund intends to change its name to “PowerShares Taxable Municipal Bond Portfolio.”
The New Index tracks the performance of U.S. dollar denominated taxable municipal debt publicly issued by U.S. states and territories, and their political subdivisions, in the U.S. domestic market. Qualifying securities must be subject to U.S. federal taxes and must have at least 18 months to maturity at point of issuance, at least one year remaining term to final maturity, a fixed coupon schedule (including zero coupon bonds), and an investment grade rating (based on an average of Moody's, S&P, and Fitch). The call date on which a pre-refunded bond will be redeemed is used for purposes of determining qualification with respect to final maturity requirements. For Build America Bonds to qualify for inclusion, the securities must have a minimum amount outstanding of $1 million and be only “direct pay” (
As of February 4, 2016, approximately 84.39% of the weight of the New Index components was composed of individual maturities that were part of an entire municipal bond offering with a minimum original principal amount outstanding of $100 million or more for all maturities of the offering. In addition, as of February 4, 2016, the total dollar amount outstanding of issues in the New Index was approximately $281,589,346,769, and the average dollar amount outstanding of issues in the New Index was approximately $ 27,808,547. Further, the most heavily weighted component represents 2.27% of the weight of the New Index, and the five most heavily weighted components represent 6.33% of the weight of the New Index.
The Exchange represents that: (1) With respect to the New Index, except for Commentary .02(a)(2) to NYSE Arca Equities Rule 5.2(j)(3), the Shares of the New Index currently satisfy all of the generic listing standards under NYSE Arca Equities Rule 5.2(j)(3); (2) the continued listing standards under NYSE Arca Equities Rules 5.2(j)(3) and 5.5(g)(2) applicable to Units shall apply to the Shares of the Fund; and (3) the Trust is required to comply with Rule 10A-3 under the Act
After careful review, the Commission finds that the proposed rule change is consistent with the requirements of Section 6 of the Act
The Commission also finds that the proposal to list and trade the Shares on the Exchange is consistent with Section 11A(a)(1)(C)(iii) of the Act,
The Commission believes that the proposal to list and trade the Shares is reasonably designed to promote fair disclosure of information that may be necessary to price the Shares appropriately and to prevent trading when a reasonable degree of transparency cannot be assured. Prior to the commencement of trading, the Exchange will inform its ETP Holders in an Information Bulletin of the special characteristics and risks associated with trading the Shares. If the Exchange becomes aware that the NAV is not being disseminated to all market participants at the same time, it will halt trading in the Shares until such time as the NAV is available to all market participants. If the IIV and the New Index value are not being disseminated as required, the Exchange may halt trading during the day in which the interruption to the dissemination of the IIV or New Index value occurs. If the interruption to the dissemination of the IIV or New Index value persists past the trading day in which it occurred, the Exchange will halt trading. Trading in Shares of the Fund will be halted if the circuit breaker parameters in NYSE Arca Equities Rule 7.12 have been reached or because of market conditions or for reasons that, in the view of the Exchange, make trading in the Shares inadvisable, and trading in the Shares will be subject to NYSE Arca Equities Rule 7.34, which sets forth circumstances under which Shares of the Fund may be halted.
Based on the Exchange's representations, the Commission believes that the New Index is
In support of this proposal, the Exchange has also made representations, including:
(1) The Adviser has managed and will continue to manage the Fund in the manner described in the Registration Statement, and it will not implement the changes described herein until this proposed rule change is operative.
(2) The Index Provider is a broker-dealer and has implemented a firewall with respect to, and will maintain procedures designed to prevent the use and dissemination of material, non-public information regarding, the New Index.
(3) With respect to the New Index, except for Commentary .02(a)(2) to NYSE Arca Equities Rule 5.2(j)(3), the Shares of Fund overlying the New Index would satisfy all of the current generic listing standards under NYSE Arca Equities Rule 5.2(j)(3).
(4) The continued listing standards under NYSE Arca Equities Rules 5.2(j)(3) and 5.5(g)(2) applicable to Units shall apply to the Shares of the Fund overlying the New Index.
(5) The Trust is required to comply with Rule 10A-3 under the Act
(6) The Shares of the Fund overlying the New Index will comply with all other requirements applicable to Units including, but not limited to, requirements relating to the dissemination of key information such as the value of the New Index and the applicable IIV,
(7) The Exchange represents that trading in the Shares will be subject to the existing trading surveillances administered by the Exchange, as well as cross-market surveillances administered by the Financial Industry Regulatory Authority (“FINRA”) on behalf of the Exchange, which are designed to detect violations of Exchange rules and federal securities laws applicable to trading on the Exchange.
(8) The Exchange or FINRA, on behalf of the Exchange, or both, will communicate as needed regarding trading in the Shares with other markets that are members of the Intermarket Surveillance Group (“ISG”). In addition, the Exchange will communicate as needed regarding trading in the Shares with other markets that are members of the ISG or with which the Exchange has in place a comprehensive surveillance sharing agreement. FINRA also can access data obtained from the Municipal Securities Rulemaking Board relating to municipal bond trading activity for surveillance purposes in connection with trading in the Shares.
The Exchange represents that all statements and representations made in this proposal regarding (a) the description of the Fund's portfolio, (b) limitations on portfolio holdings or reference assets, or (c) the applicability of Exchange rules and surveillance procedures shall constitute continued listing requirements for listing the Shares on the Exchange. The Adviser has represented to the Exchange that it will advise the Exchange of any failure by the Fund to comply with the continued listing requirements, and, pursuant to its obligations under Section 19(g)(1) of the Act, the Exchange will monitor for compliance with the continued listing requirements.
For the foregoing reasons, the Commission finds that the proposed rule change, as modified by Amendment No. 1 thereto, is consistent with Section 6(b)(5) of the Act
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (the “Act”),
The Exchange filed a proposal to amend the fee schedule applicable to Members
The text of the proposed rule change is available at the Exchange's Web site at
In its filing with the Commission, the Exchange included statements concerning the purpose of and basis for the proposed rule change and discussed any comments it received on the proposed rule change. The text of these statements may be examined at the places specified in Item IV below. The Exchange has prepared summaries, set forth in Sections A, B, and C below, of the most significant parts of such statements.
The Exchange is proposing to adopt a new Tier 4 under footnote 3, Cross-Asset Step-Up Tiers and to rename the existing Tier 4 as Tier 5. Currently, with respect to the Exchange's equities trading platform (“BZX Equities”), the Exchange determines the fee charged for the removal of liquidity or the rebate for adding liquidity that it will provide to Members using the Exchange's tiered pricing structure, which is based on the Member meeting certain volume tiers based on their ADAV
The Exchange now proposes to adopt a new tier, Tier 4, and to rename the existing Tier 4 as Tier 5. Under the proposed new Tier 4, the Exchange would provide a rebate of $0.0032 per share to Members that have an Options Step-Up Add TCV in Customer
The Exchange proposes to implement these amendments to its fee schedule January 3, 2017.
The Exchange believes that the proposed rule change is consistent with the objectives of Section 6 of the Act,
Volume-based rebates such as the proposed Cross-Asset Step-Up Tier 4 have been widely adopted by equities and options exchanges and are equitable because they are open to all Members on an equal basis and provide additional benefits or discounts that are reasonably related to the value to an exchange's market quality associated with higher levels of market activity, such as higher levels of liquidity provision and/or growth patterns, and introduction of higher volumes of orders into the price and volume discovery processes. The Exchange believes that the proposal to add a Cross-Asset Step-Up Tier 4 is a reasonable, fair and equitable, and not unfairly discriminatory allocation of fees and rebates because it will provide
Lastly, the Exchange believes the proposed tier's criteria and corresponding rebate are equitable and reasonable as compared to other Cross Asset Step-Up Tiers under footnote 3. For example, to qualify for Tier 3 and receive a rebate of $0.0029 per share, a Member must have an Options Add TCV greater than or equal to 0.30% and have a Step-Up ADAV from June 2015 greater than [sic] 1,000,000. Under the proposed tier, a Member would receive a higher rebate of $0.0032 per share where they satisfy more stringent criteria of having an Options Step-Up Add TCV in Customer orders from October 2016 baseline greater than or equal to 0.35%.
The Exchange does not believe its proposed amendment to its fee schedule would impose any burden on competition that is not necessary or appropriate in furtherance of the purposes of the Act. The Exchange does not believe that the proposed change represents a significant departure from previous pricing offered by the Exchange or pricing offered by the Exchange's competitors. Additionally, Members may opt to disfavor the Exchange's pricing if they believe that alternatives offer them better value. Accordingly, the Exchange does not believe that the proposed change will impair the ability of Members or competing venues to maintain their competitive standing in the financial markets.
The Exchange notes that it operates in a highly competitive market in which market participants can readily direct order flow to competing venues if they deem fee structures to be unreasonable or excessive. The proposed changes are generally intended to offer an incentive resulting in a rebate for adding liquidity on the Exchange, which is intended to draw additional participants to the Exchange. The Exchange does not believe that the proposed new Cross-Asset Step-Up Tier 4 would burden competition, but instead, enhance competition, as it is intended to increase the competitiveness of and draw additional volume to the Exchange. The Exchange does not believe the proposed amendments would burden intramarket competition as they would be available to all Members uniformly.
The Exchange has not solicited, and does not intend to solicit, comments on this proposed rule change. The Exchange has not received any unsolicited written comments from Members or other interested parties.
The foregoing rule change has become effective pursuant to Section 19(b)(3)(A) of the Act
Interested persons are invited to submit written data, views, and arguments concerning the foregoing, including whether the proposed rule change is consistent with the Act. Comments may be submitted by any of the following methods:
• Use the Commission's Internet comment form (
• Send an email to
• Send paper comments in triplicate to Secretary, Securities and Exchange Commission, 100 F Street NE., Washington, DC 20549-1090.
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
On November 16, 2016, BOX Options Exchange LLC (the “Exchange”) filed with the Securities and Exchange Commission (“Commission”), pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (“Act”)
Section 19(b)(2) of the Act
The Commission is extending the 45-day time period for Commission action on the proposed rule change. The Commission finds that it is appropriate to designate a longer period within which to take action on the proposed rule change so that it has sufficient time to consider and take action on the Exchange's proposed rule change.
Accordingly, pursuant to Section 19(b)(2)(A)(ii)(I) of the Act
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
Notice is hereby given of the following determinations: Pursuant to the authority vested in me by the Act of October 19, 1965 (79 Stat. 985; 22 U.S.C. 2459), E.O. 12047 of March 27, 1978, the Foreign Affairs Reform and Restructuring Act of 1998 (112 Stat. 2681,
For further information, including a list of the imported objects, contact the Office of Public Diplomacy and Public Affairs in the Office of the Legal Adviser, U.S. Department of State (telephone: 202-632-6471; email:
Notice is hereby given of the following determinations: Pursuant to the authority vested in me by the Act of October 19, 1965 (79 Stat. 985; 22 U.S.C. 2459), E.O. 12047 of March 27, 1978, the Foreign Affairs Reform and Restructuring Act of 1998 (112 Stat. 2681,
For further information, including a list of the imported objects, contact the Office of Public Diplomacy and Public Affairs in the Office of the Legal Adviser, U.S. Department of State (telephone: 202-632-6471; email:
Notice of request for public comment.
The Department of State has submitted the information collection described below to the Office of Management and Budget (OMB) for approval. In accordance with the Paperwork Reduction Act of 1995 we are requesting comments on this collection from all interested individuals and organizations. The purpose of this Notice is to allow 30 days for public comment.
The Department will accept comments from the public up to February 16, 2017.
Direct comments to the Department of State Desk Officer in the Office of Information and Regulatory Affairs at the Office of Management and Budget (OMB). You may submit comments by the following methods:
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Direct requests for additional information regarding the collection listed in this notice, including requests for copies of the proposed collection instrument and supporting documents, to Hector Perez-Casillas, who may be reached at
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We are soliciting public comments to permit the Department to:
• Evaluate whether the proposed information collection is necessary for the proper functions of the Department.
• Evaluate the accuracy of our estimate of the time and cost burden for this proposed collection, including the validity of the methodology and assumptions used.
• Enhance the quality, utility, and clarity of the information to be collected.
• Minimize the reporting burden on those who are to respond, including the use of automated collection techniques or other forms of information technology.
Please note that comments submitted in response to this Notice are public record. Before including any detailed personal information, you should be aware that your comments as submitted, including your personal information, will be available for public review.
Under INA Section 101(a)(27)(A) [8 U.S.C. 1101], Form DS-0117 is used by consular officers to determine the eligibility of an alien applicant for special immigrant status as a returning resident.
The DS-0117 is available online. Applicants will fill out the application online, print the form, and submit the DS-0117 during their interview at a Consular Post.
The Surface Transportation Board has received a request from University of California Davis (WB16-56-12/22/16) for permission to use certain unmasked data from the Board's 1986-2015 Carload Waybill Samples. A copy of this request may be obtained from the Office of Economics.
The waybill sample contains confidential railroad and shipper data; therefore, if any parties object to these requests, they should file their objections with the Director of the Board's Office of Economics within 14 calendar days of the date of this notice. The rules for release of waybill data are codified at 49 CFR 1244.9.
Federal Aviation Administration (FAA), DOT.
Notice of intent of waiver with respect to land; Chicago Midway International Airport, Chicago, Illinois.
The FAA is considering a proposal to change 0.189 acres of airport land from aeronautical use to non-aeronautical use and to authorize the sale of airport property located at 5321 South Menard Avenue, Chicago, Illinois. The land is located off airport in a residential zoned area in Chicago, IL. This land is to be sold at Fair Market Value (FMV) to a locally-based business to be used as a parking lot. The land was purchased with federal funds under the Federal Aid to Airports Program (FAAP) and currently not used for aeronautical purposes. FAR Part 77, Right of Flight, and other compatible aeronautical land-uses would continue to be protected with deed restrictions required in the transfer of land ownership. The property is no longer needed for aeronautical use.
Comments must be received on or before February 16, 2017.
Documents are available for review by appointment at the FAA Chicago Airports District Office, Al Richardson, Program Manager, 2300 East Devon Avenue, Des Plaines, IL 60018, Telephone: (847) 294-7436/
Al Richardson, Program Manager, Federal Aviation Administration, Chicago Airports District Office, 2300 East Devon Avenue, Des Plaines, IL 60018. Telephone Number: (847) 294-7436/
In accordance with section 47107(h) of Title 49, United States Code, this notice is required to be published in the
The property was acquired by the City of Chicago Department of Aviation under the Federal Aid to Airports Program (FAAP) and currently not used for aeronautical purposes. This land is to be sold at Fair Market Value (FMV) to a locally-based business to be used as a parking lot. The land was purchased with federal funds under the Federal Aid to Airports Program (FAAP) and currently not used for aeronautical purposes. FAR Part 77, Right of Flight, and other aeronautical compatible land-uses will be protected by deed restrictions in the land transfer agreement.
The disposition of proceeds from the sale of the airport property will be in accordance with FAA's Policy and Procedures Concerning the Use of Airport Revenue, published in the
This notice announces that the FAA is considering the release of the subject airport property at the Chicago Midway International Airport, Chicago, Illinois from its obligations to be maintained for aeronautical purposes. Approval does not constitute a commitment by the FAA to financially assist in the change in use of the subject airport property nor a determination of eligibility for grant-in-aid funding from the FAA.
Federal Highway Administration (FHWA), DOT.
Notice of Intent to prepare a Supplemental Environmental Impact Statement/Section 4(f) Evaluation.
The Federal Highway Administration (FHWA) in cooperation with the Florida Department of Transportation (FDOT) is issuing this notice to advise the public that a Supplemental Environmental Impact Statement/Section 4(f) Evaluation (SEIS/4f) will be prepared to evaluate new significant environmental impacts since the November 1996 approval of the Final Environmental Impact Statement/Section 4(f) Evaluation (FEIS) for the Tampa Interstate Study proposed highway project in Hillsborough County, Florida.
Cathy Kendall, Senior Environmental Protection Specialist, Federal Highway Administration, 3500 Financial Plaza, Suite 400, Tallahassee, Florida 32312, Telephone: (850) 553-2225, email:
The FHWA, in cooperation with the Florida Department of Transportation will prepare an SEIS to examine the impacts and to modify the Long Term Preferred Alternative for the Tampa Interstate Study to improve portions of I-275 (SR 93), I-4 (SR 500) and SR 60 in Hillsborough County, Florida. The proposed modification includes changes to design elements and use of innovative financing sources, including collecting tolls.
A FEIS/Section 4(f) Evaluation (FEIS# FHWA-FL-EIS-95-03-F) was issued for the Project on November 22, 1996 with Records of Decision (ROD) dated January 31, 1997 and June 14, 1999. The FEIS and RODs are available on the project Web site at:
Since issuance of the RODs, the FDOT has taken several major steps to advance the Project toward construction: The documents have been reevaluated several times (in 2000, 2001, 2002, 2003, 2006, 2008, 2009, 2011, 2013 and 2015) which advanced various elements of the project, many of which have already been constructed: Including portions of Segment 1A, Segment 2A, Segment 3A, Segment 3B and Segment 3C. The FDOT now proposes to evaluate changes in environmental impacts, new information and circumstances relevant to the proposed project and changes to preliminary engineering identified since FEIS approval. An SEIS is being prepared because FHWA has determined that the changes result in significant impacts to the human and natural environment that were not evaluated in the FEIS. The SEIS is expected to examine:
• New impacts to the human, natural and physical environment.
• Adding overpasses at several locations along I-275 to improve local street access under I-275 to better connect the communities of Tampa Heights and VM Ybor.
• Tolling the Express Lanes of the Project's improvements along I-275 and I-4.
• Changes in express lane access to local streets in the Tampa downtown area, to the I-4/Selmon Expressway Connector, and various locations from the general use lanes on I-275 and I-4.
The proposed improvement would involve the reconstruction of I-275 from East of Howard Frankland Bridge to East of Himes Avenue, I-275 from East of Himes Avenue to East of Rome Avenue, and East of Rome Avenue to North of SR 574 (Dr Martin Luther King Jr Blvd.) and I-4 from I-275 to east of 50th Street. These improvements were identified as sections 1A, 2A, 2B, 3A and 3B in the originally approved FEIS. Improvements to the corridor are considered necessary to provide for the existing and projected traffic demand.
Alternatives under consideration include: (1) Taking no further action; (2) the improvements shown in the Long Term Preferred Alternative (LTPA) in the approved FEIS, and (3) alteration of the LTPA to collect tolls for the express lanes, add more connectivity between the express lanes and the general use lanes, add express lane access to the local street network in downtown Tampa, and alter lane configuration slightly for improved future traffic operations.
Opportunities for input will be provided to appropriate federal, state,
To ensure that the full range of issues related to the proposed action is addressed and all significant issues identified, comments and suggestions are invited from all interested parties. Comments or questions concerning this proposed action and the SEIS should be directed to the FHWA at the address provided above. Questions concerning this Project and the SEIS may also be directed to Menna Yassin, Project Manager, Florida Department of Transportation, District 7, 11201 North McKinley Drive, Tampa, Florida 33612, telephone (813) 975-6433, email
Pursuant to 23 U.S.C. 139, FHWA intends to combine the Final SEIS and Record of Decision if it is practicable, to the extent possible as allowed by this provision of law.
Paperwork Reduction. The Paperwork Reduction Act seeks, in part, to minimize the cost to the taxpayer of the creation, collection, maintenance, use, dissemination, and disposition of information. Consistent with this goal and with principles of economy and efficiency in government, FHWA tries to limit insofar as possible distribution of complete printed sets of NEPA documents. Accordingly, unless a specific request for a complete printed set of the NEPA document is received before the document is printed, FHWA and FDOT will distribute only electronic copies of the NEPA document. A complete printed set of the environmental document will be available for review at FDOT's offices; an electronic copy of the complete environmental document will be available on the Project Web site.
Federal Transit Administration, DOT.
Notice of availability of Handbook.
The Federal Transit Administration (FTA) has placed in the docket and on its Web site guidance, in the form of a Handbook, on complying with FTA's Buy America pre-award and post-delivery audit requirements for revenue service rolling stock procurements, from the solicitation phase through final acceptance of the rolling stock. The Handbook explains and illustrates how to calculate domestic content of rolling stock, and is intended for use by recipients of FTA funding, auditors, manufacturers, and suppliers (including subcontractors).
The Handbook becomes effective February 16, 2017.
For program questions, Patrick Centolanzi, FTA Office of Program Management, at (202) 366-0234 or
FTA's objective in implementing 49 CFR part 661 (Buy America Requirements) and 49 CFR part 663 (Pre-Award and Post-Delivery Audits of Rolling Stock Purchases) is to support and promote the United States (U.S.) manufacturing industry and U.S. jobs. As guidance on the pre-award and post-delivery audit requirements for rolling stock procurements, FTA published two separate Buy America handbooks in May 1995—
Over the past several years, FTA has conducted Buy America Compliance Reviews, during which FTA observed and monitored the pre-award and post-delivery audit processes for fourteen capital grants. One primary finding was that FTA should provide more guidance and clarity on conducting pre-award and post-delivery Buy America audits as required in FTA's Buy America regulations (49 CFR parts 661 and 663).
As a result of that finding, FTA is issuing a new Buy America Handbook, entitled Conducting Pre-Award and Post-Delivery Audits for Rolling Stock Procurements (Handbook), which replaces the two Buy America handbooks on this subject from 1995. On June 16, 2015, FTA issued a notice of availability of the proposed handbook in the
The updated Buy America Handbook explains to recipients how to verify and document compliance with FTA's Buy America pre-award and post-delivery audit requirements. In addition, the Handbook encourages recipients, manufacturers, and suppliers to adopt certain best practices to ensure compliance with the pre-award and post-delivery audit requirements. The Handbook applies only to rolling stock procurements that are subject to the pre-award and post-delivery audit requirements set forth in 49 CFR part 663.
This notice provides a summary of the comments received regarding the proposed Handbook and the changes made to the Handbook in response to those comments. The Handbook is not included in this notice; instead, the Handbook is available on FTA's Web site, at
Several commenters suggested changes for provisions in the Handbook that are identical to regulatory provisions in 49 CFR parts 661 and 663. FTA has not accepted any of these suggested changes as the rules can only be amended through the rulemaking process. However, where a careful read showed that the Handbook was not consistent with the regulations, we have made those changes to the Handbook to ensure the Handbook tracks the regulations. In addition, some commenters took the opportunity of a public comment process on the Handbook to make recommendations for amendments to FTA's Buy America regulation. FTA expects to update the Buy America regulation in the near future, and will consider comments received to the Handbook when developing the notice of proposed rulemaking.
A number of comments were outside the scope of the notice and thus are not addressed here. For example, a commenter recommended we include language in the Handbook from the DRIVE Act, which did not become law; however, we have updated the Handbook to reflect changes to 49 U.S.C. chapter 53, as amended by the Fixing America's Surface Transportation (FAST) Act, Public Law 114-94, Dec. 4, 2015. A number of commenters made editorial suggestions, which in many cases we accepted. Further, commenters asserted in a number of instances that the proposed Handbook went beyond the Buy America regulations. While we have not discussed each instance in this notice, we have thoroughly and carefully reviewed the Handbook to ensure it does not implicitly or explicitly require more than what is required by the regulations.
Throughout the document, FTA has made edits consistent with changes the FAST Act made to 49 U.S.C. 5323(j). For example, the Handbook no longer refers to “more than 60 percent of the cost” and instead refers to “more than the minimum percentage set forth in 49 U.S.C. 5323(j)(2)(C)(i),” or similar language, to reflect the phasing in of higher minimum domestic content percentages for rolling stock between FY 2016 and FY 2020. As a second example, in section 1.2, Background, we added language from a new provision in 49 U.S.C. 5323(j)(5) that permits the cost of steel or iron that is produced in the United States and used in rolling stock frames or car shells that are produced outside of the United States to be included in the calculation of the domestic content of the rolling stock when the average cost of a vehicle in the procurement exceeds $300,000.
Section 1 of the proposed Handbook is an introductory chapter that provides a brief overview of the pre-award and post-delivery audit requirements set forth in 49 CFR parts 661 and 663, summarizes the contents of each subsequent section of the Handbook, and includes lists of relevant legal references, definitions, and acronyms.
Several commenters suggested that FTA clarify the Handbook applies only to new vehicles, and not to overhauls, rebuilds, or refurbished vehicles. We have clarified this in Subsection 1.1, Scope, and this notice therefore does not respond to comments inquiring as to how various provisions in the Handbook apply to overhauls, rebuilds, or refurbished vehicles, as those comments are outside the scope of the Handbook. We have also clarified that while Buy America requirements apply to support vehicles, the pre-award and post-delivery audit requirements apply only to vehicles used in revenue service.
Several commenters sought clarification on some of the defined terms used in the Handbook. Most of these comments related to terms that are defined in 49 CFR parts 661 and 663, and, as stated previously, FTA cannot make changes to those definitions outside of a rulemaking process. FTA has reviewed the definitions to ensure they are consistent with the regulations and made edits as appropriate. One commenter sought clarity on the use of the word “independent” in the definition of the term auditor; we have amended the definition to be consistent with the use of the term in the text of the Handbook, and the definition now states the auditor must be independent from the manufacturer and the manufacturer's agents.
Section 2 describes the pre-award audit requirements set forth in 49 CFR 663.21-27 and explains that the recipient must ensure the pre-award audit is complete before the recipient enters into a formal contract for the purchase of rolling stock. Pursuant to 49 CFR 663.23, the pre-award audit must include: A Pre-Award Buy America Certification, a Pre-Award Purchaser's Requirements Certification, and, where appropriate, a Pre-Award Certification of Compliance with or Inapplicability of Federal Motor Vehicle Safety Standards (FMVSS).
Two commenters sought clarity on how to determine whether an auditor is “qualified.” FTA has not attempted to define who is a “qualified” auditor in the Handbook, and instead relies on its recipients to make that determination. One commenter asked what “independent from the procurement process” means; specifically, whether an entity that develops and writes the specifications for a procurement would be barred from conducting Buy America audits. The original intent was that the auditor be independent from the manufacturer; we have amended the text of the Handbook by removing the requirement that an auditor be independent from the procurement process.
Several commenters had questions related to Buy America waivers. Two commenters asked what timeframe should be allowed to request, and be granted, a Buy America waiver. Some commenters wanted to know how far in advance a Buy America waiver should be requested before the contract is awarded. FTA cannot provide a definitive timeline for processing waiver requests, and recommends recipients make those requests as soon as they can. One commenter stated the Handbook was not clear as to whether waivers applied to components or to the whole vehicle. Another commenter questioned the assertion in the Handbook that a price differential waiver may be granted if including the domestic material would increase the cost of the overall project by more than 25 percent, stating the regulation provides the waiver may be granted if the price of a single component is increased by 25 percent. The discussion of Buy America waivers in section 2.2.1 of the Handbook has been revised to clarify the applicability of the three statutory waivers in 49 U.S.C. 5323(j)(2) to rolling stock procurements. By statute, the procurement of rolling stock is subject to a waiver from the requirement that manufactured goods must contain 100 percent domestic content. Section 5323(j)(2)(C) allows FTA to waive Buy America requirements for rolling stock procurements by permitting domestic content less than 100 percent. The Buy America statute also includes three additional waivers: Public interest waivers; non-availability waivers; and price differential waivers. The procedures for applying for each statutory waiver are set forth in 49 CFR 661.7. Only waivers based on public interest or non-availability may be granted for a component or subcomponent in the case of the
Public interest and non-availability waivers under 49 CFR 661.7(f) may be granted for components and subcomponents of rolling stock, and if a waiver is granted, the component or subcomponent will be considered to be of domestic origin for purposes of calculating the domestic content of the vehicle. Generally, recipients, not the manufacturer, must apply for the Buy America waiver. However, a potential bidder, offeror or supplier may seek a public interest or non-availability waiver for a component or subcomponent.
Several commenters expressed concern about the level of documentation that recipients should review and maintain. The language in the Handbook in section 2.2.1. and 2.2.2, listing the documents the recipient must review and maintain for the procurement, closely tracks the regulation at 49 CFR part 663, in particular §§ 663.23, 633.25, and Appendix D to 49 CFR 661.11. Further, an auditor must review the manufacturer's documentation that provides support for the stated costs of the components, subcomponents, and final assembly. This is part of the auditing process—verifying that the represented costs are accurate. If the manufacturer declines to provide supporting documentation for component and subcomponent costs, the Buy America domestic content cannot be verified, and the auditor will need to include this information in the pre-award audit report. The auditor needs to review enough supporting documentation to be satisfied that the vehicles will be compliant with Buy America requirements. FTA has amended the Handbook text in subsection 2.2.2. to provide guidance on maintaining confidentiality of manufacturer's proprietary information.
Commenters had similar questions about auditors reviewing documentation related to final assembly. Notably, the list of items to review is a suggested list (“. . . the auditor may perform due diligence through a variety of methods, including . . .”). One commenter suggested that including proposed final assembly costs in the Pre-Award Buy America Compliance Certification is not required by the regulation. Section 663.25 of title 49, CFR, specifically requires the recipient or its auditor to review “a description of the activities that will take place at the final assembly point and the cost of final assembly.” For pre-award, FTA acknowledges these will be estimated costs, and the Handbook uses the words “proposed” and “estimated.”
Some manufacturers also had concerns about how they could confirm their suppliers' compliance with Buy America, stating they rely on their supplier's certification of compliance, particularly given the large number of suppliers, components and subcomponents. Some objected to the recommended best practices identified in subsection 2.2.3.4. for confirming compliance. To the extent the manufacturer is asserting that components and subcomponents should be calculated as part of the domestic content of a vehicle, the manufacturer needs to be confident that its suppliers have provided compliant parts. The manufacturer will need to determine whether to take additional steps to confirm compliance with Buy America. FTA has provided some recommendations in the Handbook; this is neither an exhaustive list nor a list of required activities. One commenter suggested that FTA should require manufacturers to obtain executed certifications of compliance from their suppliers, as opposed to FTA simply recommending that manufacturers obtain such certifications. FTA has not made this a requirement in the past and it is not a requirement in the regulations, so we have maintained the provision in the Handbook as a recommendation.
One commenter objected to language in subsection 2.3.2.2. that suggests recipients should verify a manufacturer's financial viability as part of the review to certify compliance with the pre-award requirements. The commenter asserted this statement does not belong in the Buy America Handbook. Under 49 CFR 663.27, Pre-award purchaser's requirements certification, the recipient must keep on file a certification that the proposed manufacturer is a “responsible manufacturer with the capability to produce a vehicle that meets the recipient's specification set forth in the recipient's solicitation.” Financial viability is an important characteristic of a “responsible manufacturer,” and FTA has retained the language.
Section 3 describes the post-delivery audit requirements set forth in 49 CFR 663.31-39. It explains that the recipient must ensure the post-delivery audit is complete after the rolling stock is delivered to the recipient but before title to the rolling stock is transferred to the recipient, or before the rolling stock is put into revenue service, whichever comes first. Pursuant to 49 CFR 663.33, the post-delivery audit must include: A Post-Delivery Buy America Certification, a Post-Delivery Purchaser's Requirements Certification (based upon a review of the Resident Inspector's Report pursuant to 49 CFR 663.37), and a Post-Delivery Certification of FMVSS Compliance or Inapplicability, where appropriate. This section explains the requisite processes and documentation requirements for each of the post-delivery audit certifications listed above.
This section also describes best practices to aid recipients, manufacturers, and suppliers in achieving compliance with the post-delivery audit requirements, including guidance on how to prepare the requisite Resident Inspector's Report and supporting documentation, in accordance with 49 CFR 663.37, and procedures for effectively verifying compliance with the domestic content and U.S. final assembly requirements.
Several commenters noted inconsistencies in how the proposed Handbook described the post-delivery period. We have amended the Handbook to track the language used in the regulation. In response to comments, we have clarified that Post-Delivery Domestic Content Monitoring (also described as “intermediate audits”) is a recommended best practice that would occur after the vehicle manufacturer delivers the first vehicle to the recipient and until the vehicle manufacturer transfers title to the last vehicle to the recipient or the recipient puts the last vehicle into revenue service, whichever is first. Specifically, FTA added subsection 3.1.3.4 to the Handbook to address the concerns regarding post-delivery monitoring raised by the commenters.
Several commenters expressed concern regarding the possibility of having to produce proprietary information to show Buy America compliance. FTA has amended the Handbook to address these concerns, in sections 2 and 3 and an added “FAQ” in section 5. If a manufacturer is concerned about releasing proprietary information, the manufacturer and recipient may agree that the recipient will contract with an external consultant to conduct the manufacturer's Buy America certification review. Alternatively, the recipient may be able to keep its Buy America audit function independent by using a “firewall” and assuring the manufacturer that those employees of the recipient performing the Buy America audit are prohibited from disclosing any of the manufacturer's proprietary data. Further, the review of
We also have amended the Handbook to track the regulation with regard to the information the recipient must keep on file. The recipient is not required to maintain a list of components and subcomponents and their costs for a procured vehicle—the recipient is required to review that information (as provided by the manufacturer), or have an independent auditor review that information, and certify that it is satisfied that the rolling stock meets the Buy America requirements.
One commenter asked if a Post-Delivery Audit is required if FTA granted a waiver from the Buy America requirements. There may be situations in which a full or partial audit would still be required, and FTA will address post-delivery audit requirements in the letter granting any waiver from Buy America requirements. In the event FTA issues a general waiver for a certain class of vehicles, if the
As with other sections of the Handbook, FTA has made edits to clarify intent, to ensure consistency with the regulations, and to improve readability.
This section provides guidance on how to calculate domestic content correctly for rolling stock procurements in accordance with 49 CFR 661.11, providing guidance relevant to both the pre-award audit and the post-delivery audit.
The introductory portion of this section has been amended to better explain how to conduct a proper Domestic Content Calculation consistent with 49 CFR 661.11. FTA has observed that some recipients and vendors, or their agents or auditors, are calculating the domestic content amount by dividing the total costs of the domestic components by the estimated value of the vehicle, found by subtracting certain costs from the Contract Total Price of the vehicles. This calculation is not consistent with 49 CFR 661.11 and fails to demonstrate compliance. Additional information is included to add instruction for doing a proper Domestic Content Calculation consistent with 49 CFR 661.11.
Commenters generally objected to the inclusion of the total contract price or total vehicle cost in the analysis, as those values are not relevant to the Buy America domestic content calculations, which are based on vehicle material costs. FTA agrees with commenters and we have removed the subsections addressing these values, and have also removed references to the total contract price and total vehicle cost from the rest of the Handbook.
In response to comments, we have made edits to subsection 4.3, which provides a sample Domestic Content Worksheet with detailed step-by-step instructions for how to fill out the worksheet and calculate domestic content. Commenters generally sought clarification on the required domestic content and how that calculation affects the step by step analysis in the worksheet. Similarly, the commenters raised questions about how the cost of the components (foreign and domestic) and subcomponents affect the calculations. We have included references to the regulations as well as additional text to add clarity to the spreadsheets.
A number of commenters objected to the list of “Non-Recurring Expenses” or NREs, described in subsection 4.4. As with the total contract price and total vehicle price, FTA agrees with commenters that these values are not necessary for the calculation of domestic content for Buy America purposes. Given the regulation describes the cost of a component or subcomponent as the price a bidder or offeror pays, the NREs are already captured in the retail price of the component or subcomponent.
As with other sections of the Handbook, FTA has made edits in section 4 for clarity and consistency with the regulations.
Section 5 addresses some of the most frequently asked questions (FAQs) about pre-award and post-delivery audits. Among numerous other topics, the FAQs concern what types of rolling stock are not subject to the pre-award and post-delivery audit requirements; how to calculate domestic content; and the responsibilities of the resident inspector. The majority of comments to this section addressed inconsistencies or perceived inconsistencies between the FAQs and the rest of the Handbook, the regulations, or the statute. FTA has carefully reviewed section 5 and made edits as appropriate. In addition, for clarity, we have added the regulatory citations to the FAQs where appropriate, and, at the suggestion of commenters, added an FAQ related to confidentiality of manufacturer's proprietary information.
The proposed Handbook contained four appendices. The appendices provide sample forms, spreadsheets and format for a resident inspector's report. These are samples only and, with the exception of the two Buy America certification forms (B.1 and B.2) in Appendix B, which are required by the regulations, recipients may choose to use their own forms, spreadsheets, and format for the resident inspector's report, provided the recipient's forms, etc., contain the information required by the regulations.
In the proposed Handbook, FTA included Appendix A, which contained domestic content calculation worksheets, including one worksheet for rail vehicles and one worksheet for buses. Commenters noted that some of the identified “components” in Appendix A are not included in Appendices B and C to 49 CFR 661.11. Commenters asserted that, absent a rulemaking, the components included in Appendix A of the Handbook should track the appendices to section 661.11. While Appendices B and C to section 661.11 note that the list of components is not exhaustive, FTA agrees that the Handbook is not the appropriate vehicle to “officially” expand on that list. Given that Appendix A contained information not consistent with the regulations, and that Section 4 contains step-by-step instructions for calculating domestic content, we have removed Appendix A in its entirety and re-numbered the other three appendices accordingly.
Appendix A in the final Handbook, as so re-numbered, contains sample compliance checklists for recipients, manufacturers, and suppliers to use in order to ensure that the Pre-Award and Post-Delivery Buy America Certifications and Purchaser's Requirements Certifications are properly completed. This appendix also contains a sample Resident Inspector's Report, which the recipient must review before
Appendix B contains sample pre-award and post-delivery certificates and forms. These samples are intended to aid recipients, manufacturers, and suppliers in complying with the 49 CFR parts 661 and 663 requirements, and these samples may be utilized and filled out by these parties, where appropriate. In response to comments, FTA made edits for clarity and for consistency with the regulations.
Appendix C contains a sample pre-award audit report and a sample post-delivery audit report, including necessary certifications and recommended supporting documentation. In response to comments, FTA made edits for clarity and for consistency with the regulations. FTA also made edits to simplify the sample reports.
Federal Transit Administration, DOT.
Notice of request for comments.
In accordance with the Paperwork Reduction Act of 1995, this notice announces the intention of the Federal Transit Administration (FTA) to request the Office of Management and Budget (OMB) to approve the revision of the following information collection: Metropolitan and Statewide and Nonmetropolitan Transportation Planning.
Comments must be submitted before March 20, 2017.
To ensure that your comments are not entered more than once into the docket, submit comments identified by the docket number by only one of the following methods:
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Metropolitan and Statewide and Nonmetropolitan Transportation Planning—Mr. Dwayne Weeks, Office of Planning and Environment, (202) 493-0316, or email:
Interested parties are invited to send comments regarding any aspect of this information collection, including: (1) The necessity and utility of the information collection for the proper performance of the functions of the FTA; (2) the accuracy of the estimated burden; (3) ways to enhance the quality, utility, and clarity of the collected information; and (4) ways to minimize the collection burden without reducing the quality of the collected information. Comments submitted in response to this notice will be summarized and/or included in the request for OMB approval of this information collection.
In addition to serving as a management tool for MPOs, the UPWP is used by both FTA and FHWA to monitor the transportation planning activities of MPOs. It also is needed to establish national out year budgets and regional program plans, develop policy on using funds, monitor State and local compliance with technical emphasis areas, respond to Congressional inquiries, prepare Congressional testimony, and ensure efficiency in the use and expenditure of Federal funds by determining that planning proposals are both reasonable and cost-effective. 49 U.S.C. 5303 and 23 U.S.C.134(j) require the development of TIPs for urbanized areas; STIPs are mandated by 49 U.S.C. 5304 and 23 U.S.C. 135(g) for an entire State. After approval by the Governor and MPO, metropolitan TIPs in attainment areas are to be incorporated directly into the STIP. For nonattainment areas, FTA/FHWA must make a conformity finding on the TIPs before including them in the STIP. The complete STIP is then jointly reviewed and approved or disapproved by FTA and FHWA. These conformity findings and approval actions constitute the determination that States are complying
The FTA and FHWA updated their method for estimating the annual burden hours of the transportation planning programs on respondents to reflect the Final Rule on Statewide and Nonmetropolitan Transportation Planning and Metropolitan Transportation Planning. On July 6, 2012, the President signed into law Public Law 112-141, the Moving Ahead for Progress in the 21st Century Act (MAP-21) and on December 4, 2015, signed into law Public Law 114-94, the Fixing America's Surface Transportation Act (FAST). The MAP-21 makes significant changes to the statewide and nonmetropolitan planning process and the metropolitan transportation planning process, and the FAST makes minor changes to existing provisions. As a result, FHWA and FTA have issued a final rule that makes the regulations consistent with current statutory requirements. The rule is central to the implementation of the overall performance management framework created by MAP-21.
The changes to the FHWA/FTA statewide and nonmetropolitan and metropolitan transportation planning regulations (23 CFR part 450 and 49 CFR part 613) make the regulations consistent with current statutory requirements. Major regulatory revisions include a new mandate for States and MPOs to take a performance-based approach to planning and programming; a new emphasis on the nonmetropolitan transportation planning process, by requiring States to have a higher level of involvement with nonmetropolitan local officials and providing a process for the creation of regional transportation planning organizations (RTPOs); a structural change to the membership of the larger MPOs; a new framework for voluntary scenario planning; and a process for programmatic mitigation plans. The revised burden hour estimates reflect the annual compliance burden of the requirements in the Final Rule on Statewide and Nonmetropolitan Transportation Planning and Metropolitan Transportation Planning published on May 27, 2016.
Federal Transit Administration (FTA), DOT.
Notice of proposed general directive; request for comments.
FTA has placed in the docket and on its Web site a proposed General Directive to address safety risks associated with stop signal overruns. The proposed directive follows FTA's review and analysis of data and information submitted in response to the agency's
Comments must be received by March 20, 2017. Any comments filed after this deadline will be considered to the extent practicable.
Please identify your submission by Docket Number [FTA-2016-0041] through one of the following methods:
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For program matters, Candace Key, Acting Director, Office of System Safety, (202) 366-9178 or
In accordance with 49 CFR 670.25, the Federal Transit Administration (FTA) is proposing a General Directive to address the combination of unsafe conditions and practices that lead to stop signal overruns and the risks of death or personal injury or damage to property or equipment. The proposed directive follows FTA's review and analysis of data and information submitted in response to the agency's
FTA requests public comment on this proposed General Directive, which is available in its entirety on the FTA public Web site at
Pipeline and Hazardous Materials Safety Administration (PHMSA), Department of Transportation (DOT).
Notice and request for comments on Information Collection Approvals.
This notice announces Office of Management and Budget (OMB) approval and extension for four Information Collection Requests (ICRs). Specifically, this notice announces the following: OMB approval and extension until February 28, 2018 for OMB Control No. 2137-0586, “Hazardous Materials Public Sector Training & Planning Grants”; OMB approval and extension until March 31, 2019 for OMB Control No. 2137-0628, “Flammable Hazardous Materials by Rail Transportation”; and OMB approval and extension until June 30, 2019 for both OMB Control No. 2137-0613, “Subsidiary Hazard Class and Number/Type of Packagings,” and OMB Control No. 2137-0510, “Radioactive (RAM) Transportation Requirements.”
The expiration dates for the ICRs approved by OMB are February 28, 2018; March 31, 2019; or June 30, 2019, as indicated under the
Requests for a copy of an information collection should be directed to Steven Andrews or T. Glenn Foster, Office of Hazardous Materials Standards (PHH-12), Pipeline and Hazardous Materials Safety Administration, 1200 New Jersey Avenue SE., Washington, DC 20590-0001.
Steven Andrews or T. Glenn Foster, Office of Hazardous Materials Standards (PHH-12), Pipeline and Hazardous Materials Safety Administration, 1200 New Jersey Avenue SE., Washington, DC 20590-0001, Telephone (202) 366-8553.
OMB regulations (5 CFR part 1320) implementing provisions of the Paperwork Reduction Act of 1995 (Pub. L. 104-13) require that interested members of the public and affected agencies have an opportunity to comment on information collection and recordkeeping activities (
Office of the Secretary, DOT.
Notice of intent to designate Beyond Traffic Innovation Centers.
Proposals must be submitted by 11:59 p.m. EST on December 21, 2016.
Final proposals must not exceed 4 pages in length, and must be submitted electronically to:
For further information concerning this notice, please contact
The Department is requesting applications to be designated as a USDOT Beyond Traffic Innovation Center. Read this notice in its entirety so that you have all the information you need to determine whether you would like to submit a proposal.
• How will we move? How will we build a transportation system to accommodate a growing population and changing travel patterns?
• How will we move things? How will we reduce freight chokepoints that drive up the cost of owning a business?
• How will we move better? How will we knock down barriers to new technologies that promise to make travel safer and more convenient?
• How will we adapt? How will we make our infrastructure resilient to more frequent catastrophic weather events?
• How will we grow opportunity for all Americans?
• How will we align decisions and dollars, and invest the trillions of dollars our transportation system needs in the smartest way possible?
• U.S. non-profit institutions of higher education as defined under 20 U.S.C. 1001(a). Non-profit institutions of higher education may include qualifying two-year institutions that meet the requirements of 20 U.S.C. 1001(a). This includes existing and future University Transportation Centers and applicants.
• Non-profit organizations described under section 501(c)(3) of the Internal Revenue Code of 1986 (IRC) and exempt from tax under section 501(a) of such code.
Applications must include the following:
• Commitment to continuing the conversation launched by
DOT will also consider the following:
• The extent to which the applicant demonstrates the commitment outlined above and administers an established academic or outreach program.
• The capability of the applicant to provide leadership in making national and regional contributions to the conversation around the future of our transportation system.
• The applicant's ability and willingness to maintain a working relationship with the Department's relevant research program offices. The application should describe this proposed relationship, including aspects such as potential participation in conferences, meetings, joint research efforts, and submission of activity reports to the DOT on a routine basis.
• The extent to which the State or locality in which the applicant is located can provide applicable solutions for the broader region and surrounding corridor for improved mobility through the advancement of emerging technologies.
• The demonstrated research and extension resources available to the applicant for carrying out activities and programs as they relate to
Office of Foreign Assets Control, Treasury.
Notice.
The Department of the Treasury's Office of Foreign Assets Control (OFAC) is publishing the names of 4 individuals whose property and interests in property are blocked pursuant to Executive Order 13224 of September 23, 2001, “Blocking Property and Prohibiting Transactions With Persons Who Commit, Threaten To Commit, or Support Terrorism.”
OFAC's actions described in this notice were effective on January 10, 2017.
Associate Director for Global Targeting, tel.: 202/622-2420, Assistant Director for Sanctions Compliance & Evaluation, tel.: 202/622-2490, Assistant Director for Licensing, tel.: 202/622-2480, Office of Foreign Assets Control, or Chief Counsel (Foreign Assets Control), tel.: 202/622-2410, Office of the General Counsel, Department of the Treasury (not toll free numbers).
The SDN List and additional information concerning OFAC sanctions programs are available from OFAC's Web site (
On January 10, 2017, OFAC blocked the property and interests in property of the following 4 individuals pursuant to E.O. 13224, “Blocking Property and Prohibiting Transactions With Persons Who Commit, Threaten To Commit, or Support Terrorism”:
1. SHARROUF, Khaled (a.k.a. ZARQAWI AL AUSTR, Abu; a.k.a. ZARQAWI AUSTRALI, Abu; a.k.a. ZARQAWI, Abu), Syria; Iraq; DOB 23 Feb 1981; POB Auburn, New South Wales, Australia; nationality Australia; Gender Male; Passport L3135591 (Australia); alt. Passport L5210356 (Australia); alt. Passport N723649 (Australia); Driver's License No. 12789234 (Australia) (individual) [SDGT] (Linked To: ISLAMIC STATE OF IRAQ AND THE LEVANT).
2. PRAKASH, Neil Christopher (a.k.a. KHALED AL-CAMBODI, Abu), Syria; Iraq; DOB 07 May 1991; POB Melbourne, Australia; nationality Australia; Gender Male; Passport N4325853 (Australia) (individual) [SDGT] (Linked To: ISLAMIC STATE OF IRAQ AND THE LEVANT).
3. ROCHMAN, Oman (a.k.a. ABDULROHMAN, Oman; a.k.a. ABDURAHMAN, Aman; a.k.a. ABDURRACHMAN, Aman; a.k.a. ABDURRAHMAN AL-ARKHABILIY, Abu Sulaiman Aman; a.k.a. ABDURRAHMAN, Aman; a.k.a. ABDURRAHMAN, Oman; a.k.a. RAHMAN, Aman Abdul; a.k.a. RAHMAN, Oman), Pasir Putih Prison, Nusa Kambangan Island, Indonesia; DOB 05 Jan 1972; POB Sumedang, Indonesia; nationality Indonesia; Gender Male; Ustadz (individual) [SDGT] (Linked To: ISLAMIC STATE OF IRAQ AND THE LEVANT).
4. USMAN, Bachrumsyah Mennor (a.k.a. SYAH, Bahrum; a.k.a. “BACHRUMSHAH”; a.k.a. “BACHRUMSYAH”; a.k.a. “BAHRUMSYAH”; a.k.a. “IBRAHIM, Abu”; a.k.a. “MUHAMMAD AL-ANDUNISIY, Abu”; a.k.a. “MUHAMMAD AL-INDONESI, Abu”; a.k.a. “MUHAMMAD AL-INDUNISI, Abu”; a.k.a. “SHABRINA, Abu”), Raqqa, Syria; Al-Shadadi, Hasaka Province, Syria; DOB 23 Jul 1984; POB Bogor, Indonesia; nationality Indonesia; Gender Male; Passport A8329173 (Indonesia); Ustad (individual) [SDGT] (Linked To: ISLAMIC STATE OF IRAQ AND THE LEVANT).
Department of Veterans Affairs.
Notice.
The Department of Veterans Affairs (VA), is announcing the availability of funds for the Specially Adapted Housing Assistive Technology (SAHAT) Grant Program for fiscal year (FY) 2017. The objective of the grant is to encourage the development of new assistive technologies for specially adapted housing.
This Notice is intended to provide applicants with the information necessary to apply for the SAHAT Grant Program. Registration will be available at
Applications for the SAHAT Grant Program must be submitted via
Bryant Lacey (Program Manager), Specially Adapted Housing Program, Department of Veterans Affairs, 810 Vermont Avenue NW., Washington, DC 20420, (202) 632-8955 (not a toll-free number).
Pursuant to the Veterans' Benefit Act of 2010, the Secretary of Veterans Affairs (Secretary), through the Loan Guaranty Service (LGY) of the Veterans Benefits Administration (VBA), is authorized to provide grants of financial assistance to develop new assistive technology. The objective of the grant, known as the Specially Adapted Housing Assistive Technology (SAHAT) Grant Program, is to encourage the development of new assistive technologies for adapted housing.
LGY currently administers the Specially Adapted Housing (SAH) Program. Through this program, LGY provides funds to eligible veterans and servicemembers with certain service-connected disabilities to help purchase or construct an adapted home, or modify an existing home, to allow them to live more independently. Currently, most SAH adaptations involve structural modifications such as ramps, wider hallways and doorways, roll-in showers and other accessible bathroom features, etc. For more information about the SAH Program, please visit:
VA acknowledges there are many emerging technologies that could improve home adaptions or otherwise enhance a veteran's or servicemember's ability to live independently, such as voice-recognition and voice-command operations, living environment controls, and adaptive feeding equipment. Therefore, VA has defined “new assistive technology” as an advancement that the Secretary determines could aid or enhance the ability of a veteran or servicemember to live in an adapted home. SAHAT funding will support the creation of assistive technologies that veterans and servicemembers can use in order to facilitate optimal independence in their homes.
Please Note: SAHAT funding does not support the construction or modification of residential dwellings for accessibility. Veterans and servicemembers interested in receiving assistance to adapt a home are encouraged to review the following factsheet:
Public Law 111-275, the Veterans' Benefits Act of 2010 (the Act), was enacted on October 13, 2010. Section 203 of the Act amended chapter 21, title 38, United States Code (U.S.C.), to establish the SAHAT Grant Program. The Act authorized VA to provide grants of up to $200,000 per fiscal year, through September 30, 2016, to a “person or entity” for the development of specially adapted housing assistive technologies limited to $1 million, the aggregate amount of such grants VA may award in any fiscal year.
On September 29, 2016, Public Law 114-228, the Department of Veterans Affairs Expiring Authorities Act of 2016 was enacted. Title IV, Section 409 extended the authority for VA to provide grants in the manner listed above, through September 30, 2017.
Grantees will be expected to leverage grant funds to develop new assistive technologies for specially adapted housing. Pursuant to 36 CFR 36.4412, the Secretary may establish scoring priorities based on the specific needs of veterans and servicemembers. For FY 2017, the Secretary has established innovation and unmet needs, as described in scoring criteria 1 and 2 contained in Section V(A) of this notice, as top priorities. Additional information regarding how these priorities will be scored is contained in Section V(A) of this notice.
Definitions of terms used in the SAHAT Grant Program are found at 38 CFR 36.4412(b).
Pursuant to 38 CFR 36.4412(i), each VA employee appointed to or lawfully fulfilling any of the following positions is hereby delegated authority, within the limitations and conditions prescribed by law, to exercise the powers and functions of the Secretary with respect to the SAHAT Grant Program authorized by 38 U.S.C. 2108:
The aggregate amount of assistance VA may award in any fiscal year is limited to $1 million. This funding will be provided as an assistance agreement in the form of grants. The number of assistance agreements VA will fund as a result of this notice will be based on the quality of the technology grant applications received and the availability of funding. However, the maximum amount of assistance a technology grant applicant may receive in any fiscal year is limited to $200,000.
Funding for these projects is not guaranteed and is subject to the availability of funds and the evaluation of technology grant applications based on the criteria in this announcement. In appropriate circumstances, VA reserves the right to partially fund technology grant applications by funding discrete portions or phases of proposed projects. If VA decides to partially fund a technology grant application, it will do so in a manner that does not prejudice any application or affect the basis upon which the application, or portion thereof, was evaluated and selected for award, and therefore maintains the integrity of the competition and selection process. Award of funding through this competition is not a guarantee of future funding. The SAHAT Grant Program is administered annually and does not guarantee subsequent awards. Renewal grants to provide new assistive technology will not be considered under this announcement.
The anticipated start date of grants funded under this announcement is April 3, 2017. Grant projects must be closed out by September 30, 2018.
As authorized by 38 U.S.C. 2108, the Secretary may provide a grant to a “person or entity” for the development of specially adapted housing assistive technologies. In order to foster competition and best serve the needs of veterans and servicemembers, VA is placing no restrictions on the types of eligible entities, except as noted in Section III(C) of this notice.
There is no cost sharing, matching, or cost participation for the SAHAT Grant Program. However, leveraged resources will be considered as an evaluation criterion during the application review process (see scoring criterion 6 in Section V of this announcement). Leveraged resources are not included in the approved budget (outlined in the Standard Form 424A—BUDGET INFORMATION—Non-Construction Programs) for the project and need not be an eligible and allowable cost under the grant. Any form of proposed leveraging that is evaluated under Section V scoring criteria must be included in the application and the application must describe how the technology grant applicant will obtain the leveraged resources and what role VA funding will play in the overall project.
As stated in Section III(A), VA is placing no restrictions on the types of eligible entities. However, all technology grant applicants and applications must meet the threshold criteria set forth below. Failure to meet any of the following threshold criteria in the application will result in the automatic disqualification for funding consideration. Ineligible participants will be notified within 30 days of the finding of disqualification for award consideration based on the following threshold criteria:
1. Projects funded under this notice must involve new assistive technologies that the Secretary determines could aid or enhance the ability of a veteran or servicemember to live in an adapted home.
2. Projects funded under this notice must not be used for the completion of work which was to have been completed under a prior grant.
3. Applications in which the technology grant applicant is requesting assistance funds in excess of $200,000 will not be reviewed.
4. Applications that do not comply with the application and submission information provided in Section IV of this notice will be rejected.
5. Applications submitted via mail, email, or facsimile will not be reviewed.
6. Applications must be received through
7. Technology grant applicants that have an outstanding obligation to the Federal Government that is in arrears or have an overdue or unsatisfactory response to an audit will be deemed ineligible.
8. Technology grant applicants in default by failing to meet the requirements for any previous Federal assistance will be deemed ineligible.
9. Applications submitted by entities deemed ineligible will not be reviewed.
10. Applications with project dates that extend past September 30, 2018, will not be reviewed.
All technology grant recipients, including individuals and entities formed as for-profit entities, will be subject to the rules on Uniform Administrative Requirements for Grants and Agreements With Institutions of Higher Education, Hospitals, and other Non-profit Organizations, as found at 2 CFR part 200. Where the Secretary determines that 2 CFR part 200 is not applicable or where the Secretary determines that additional requirements are necessary due to the uniqueness of a situation, the Secretary will apply the same standard applicable to exceptions under 2 CFR 200.102.
Technology grant applicants may download the application package from
The SAHAT Grant Program application package provided at
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a. A project description, including the goals and objectives of the project, what the project is expected to achieve, and how the project will benefit veterans and servicemembers.
b. An estimated schedule including the length of time (not to extend past September 30, 2018) needed to accomplish tasks and objectives for the project.
c. A description of what the project proposes to demonstrate and how this new technology will aid or enhance the ability of veterans and servicemembers to live in an adapted home. The following link has additional information regarding adapted homes:
d. Each technology grant applicant is responsible for ensuring that the application addresses each of the scoring criteria listed in Section V(A) of this notice.
Each technology grant applicant, unless the applicant is an individual or Federal awarding agency that is excepted from these requirements under 2 CFR 25.110(b) or (c), or has an exception approved by VA under 2 CFR 25.110(d), is required to:
1. Be registered in SAM prior to submitting an application;
2. Provide a valid DUNS number in the application; and
3. Continue to maintain an active SAM registration with current
VA will not make an award to an applicant until the applicant has complied with all applicable DUNS and SAM requirements and, if the applicant has not fully complied with the requirements by the time VA is ready to make an award, VA will determine the applicant is not qualified to receive a Federal award and will use this determination as a basis for making the award to another applicant.
Applications for the SAHAT Grant Program must be submitted via
Applications submitted via
It is the responsibility of grant applicants to ensure a complete application is submitted via
It is recommended that confidential business information (CBI) not be included in your application. However, if CBI is included in your application, it will be handled by VA in accordance with 2 CFR 200. Applicants must clearly indicate which portion(s) of their application they are claiming as CBI. VA will evaluate such claims in accordance with 2 CFR 200. If no claim is made, VA is not required to make an inquiry of the applicant. If CBI is included, please provide as much detail as possible to ensure a comprehensive review of the application can be completed.
This section is not applicable to the SAHAT Grant Program.
The SAHAT Grant Program does not allow reimbursement of pre-award costs.
Each eligible proposal (based on the Section III threshold eligibility review) will be evaluated according to the criteria established by the Secretary and provided as described below in Section A.
The Secretary will score technology grant applications based on the scoring criteria listed below. As indicated in Section I of this notice, the Secretary is placing the greatest emphasis on criteria 1 and 2. The establishment of priorities does not establish new scoring criteria but is designed to assist technology grant applicants in understanding how scores will be weighted. Although there is not a cap on the maximum aggregate score possible, a technology grant application must receive a minimum aggregate score of 70. Instructions for completion of the scoring criteria are listed on VA Form 26-0967a. This form is included in the application package materials on
1. A description of how the new assistive technology is innovative (up to 50 points);
2. An explanation of how the new assistive technology will meet a specific, unmet need among eligible individuals (up to 50 points);
3. An explanation of how the new assistive technology is specifically designed to promote the ability of eligible individuals to live more independently (up to 30 points);
4. A description of the new assistive technology's concept, size, and scope (up to 30 points);
5. An implementation plan with major milestones for bringing the new assistive technology into production and to the market. Such milestones must be meaningful and achievable within a specific timeframe (up to 30 points); and
6. An explanation of what uniquely positions the technology grant applicant in the marketplace. This can include a focus on characteristics such as the economic reliability of the technology grant applicant, the technology grant applicant's status as a minority or Veteran-owned business, or other characteristics that the technology grant applicant wants to include to show how it will help protect the interests of, or further the mission of, VA and the program (up to 20 points).
Eligible applications will be evaluated by a five-person review panel comprised of VA employees. The review panel will score applications using the scoring criteria provided in Section V(A), with the greatest emphasis being placed on scoring criteria 1 and 2. The review panel will then rank those applications that receive a minimum aggregate score of 70 in order from highest to lowest. The delegated official will select the highest ranked application(s) based on, and subject to, the availability of funds.
Although subject to change, the SAHAT Grant Program Office expects to announce grant recipients by April 1, 2017. Prior to executing any funding agreement, VA will contact successful applicants, make known the amount of proposed funding, and verify the applicant's desire to receive the funding. Any communication between the SAHAT Grant Program Office and successful applicants prior to the issuance of an award notice is not authorization to begin project activities. Once VA verifies that the grant applicant is still seeking funding, VA will issue a signed and dated award notice. The award notice will be sent by U.S. Mail to the organization listed on the SF-424.
All applicants will be notified by letter, sent by U.S. Mail to the address listed on the SF-424.
This section is not applicable to the SAHAT Grant Program.
VA places great emphasis on the responsibility and accountability of grantees. Grantees must agree to cooperate with any Federal evaluation of the program and provide the following:
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Competition-related disputes associated with this announcement will be resolved in accordance with 2 CFR 200,
For additional general information about this announcement contact the program official: Bryant Lacey (Program Manager), Specially Adapted Housing Program,
If mailing correspondence, other than application material, please send to: Loan Guaranty Service, VA Central Office, Attn: Bryant Lacey (262), 810 Vermont Avenue NW., Washington, DC 20420.
All correspondence with VA concerning this announcement should reference the funding opportunity title and funding opportunity number listed at the top of this solicitation. Once the announcement deadline has passed, VA staff may not discuss this competition with applicants until the application review process has been completed.
38 U.S.C. 2108 authorizes VA to provide grants for the development of new assistive technologies through September 30, 2017. Additional information related to the SAH program administered by LGY is available at:
The SAHAT Grant is not a veterans' benefit. As such, the decisions of the Secretary are final and not subject to the same appeal rights as decisions related to veterans' benefits. The Secretary does not have a duty to assist technology grant applicants in obtaining a grant.
Grantees will receive payments electronically through the U.S. Department of Health and Human Services Payment Management System.
The Secretary of Veterans Affairs, or designee, approved this document and authorized the undersigned to sign and submit the document to the Office of the Federal Register for publication electronically as an official document of the Department of Veterans Affairs. Gina S. Farrisee, Deputy Chief of Staff, approved this document on January 3, 2017, for publication.
Centers for Medicare & Medicaid Services, HHS.
Final rule.
This final rule revises the procedures that the Department of Health and Human Services (HHS) follows at the Administrative Law Judge (ALJ) level for appeals of payment and coverage determinations for items and services furnished to Medicare beneficiaries, enrollees in Medicare Advantage (MA) and other Medicare competitive health plans, and enrollees in Medicare prescription drug plans, as well as appeals of Medicare beneficiary enrollment and entitlement determinations, and certain Medicare premium appeals. In addition, this final rule revises procedures that the Department of Health and Human Services follows at the Centers for Medicare & Medicaid Services (CMS) and the Medicare Appeals Council (Council) levels of appeal for certain matters affecting the ALJ level.
These regulations are effective on March 20, 2017.
Joella Roland, (410) 786-7638 (for issues related to CMS appeals policies and reopening policies).
Jason Green, (571) 777-2723 (for issues related to Administrative Law Judge appeals policies).
Angela Roach, (202) 565-0132 (for issues related to Council appeals policies).
Because we refer to a number of terms by abbreviation or a shortened form in this proposed rule, we are listing these abbreviations and shortened forms, and their corresponding terms in alphabetical order below:
Independent of the standards in this final rule, the Department commits to complying with section 1557 of the Affordable Care Act, Pub. L. 111-148, 124 Stat. 470 (42 U.S.C. 18116), which prohibits discrimination on the basis of race, color, national origin, sex, age, or disability in certain health programs and activities. HHS issued a final rule to implement section 1557,
In accordance with provisions of sections 1155, 1852, 1860D-4, 1869, and 1876 of the Social Security Act (Act), and associated implementing regulations, there are multiple administrative appeal processes for Medicare fee-for-service (Part A and Part B) claim, entitlement and certain premium initial determinations; MA (Part C) and other competitive health plan organization determinations; and Part D plan sponsor coverage determinations and certain premium determinations. The first, and in many instances a second, level of administrative appeal are administered by Medicare contractors, Part D plan sponsors, MA organizations or Medicare plans, or by the SSA. For example, under section 1869 of the Act, the Medicare claims appeal process involves redeterminations conducted by the Medicare Administrative Contractors (which are independent of the staff that made the initial determination) followed by reconsiderations conducted by Qualified Independent Contractors (QICs). However, all of the appeals discussed in this final rule can be appealed to the ALJs at the Office of Medicare Hearings and Appeals (OMHA) if the amount in controversy requirement and other requirements are met after these first and/or second levels of appeal.
OMHA, a staff division within the Office of the Secretary of HHS, administers the nationwide ALJ hearing program for Medicare claim, organization and coverage determination, and entitlement and certain premium appeals. If the amount in controversy and other filing requirements are met, a hearing before an ALJ is available following a Quality Improvement Organization (QIO) reconsidered determination under section 1155 of the Act; a Social Security Administration (SSA) or QIC reconsideration, or a request for QIC reconsideration for which a decision is not issued timely and a party requests escalation of the matter under section 1869(b)(1)(A) and (d) of the Act (Part A and Part B appeals); an Independent Review Entity (IRE) reconsideration or QIO reconsidered determination under sections 1876(c)(5)(B) or 1852(g)(5) of the Act (Part C and other managed health plan appeals); or an IRE reconsideration under section 1860D-4(h) of the Act (Part D appeals). In addition, under current regulations a review by an ALJ is available following a dismissal of a request for reconsideration, if the amount in controversy and other filing requirements are met.
OMHA provides Medicare beneficiaries and the providers and suppliers that furnish items or services to Medicare beneficiaries, as well as applicable plans, Medicare Advantage Organizations (MAOs), and Medicaid State agencies with a fair and impartial forum to address disagreements regarding: Medicare coverage and
OMHA ALJs began adjudicating appeals in July 2005, based on section 931 of the MMA, which required the transfer of responsibility for the ALJ hearing level of the Medicare claim and entitlement appeals process from SSA to HHS. New rules at 42 CFR part 405, subpart I and subpart J were also established to implement statutory changes to the Medicare fee-for-service (Part A and Part B) appeals process made by BIPA in 2000 and the MMA in 2003. Among other things, these new rules addressed appeals of reconsiderations made by QICs, which were created by BIPA for the Part A and Part B programs. These rules also apply to appeals of SSA reconsiderations. The statutory changes made by BIPA included a 90-day adjudication time frame for ALJs to adjudicate appeals of QIC reconsiderations beginning on the date that a request for an ALJ hearing is timely filed. The new part 405, subpart I rules were initially proposed in the November 15, 2002
In addition to the part 405, subpart I rules, OMHA applies the rules at 42 CFR part 478, subpart B to individuals' appeals of QIO reconsidered determinations; part 422, subpart M to appeals of IRE reconsiderations or QIO reconsidered determinations under the MA (Part C) and other competitive health plan programs; and part 423, subpart U to appeals of IRE reconsiderations under the Medicare prescription drug (Part D) program.
In recent years, the Medicare appeals process has experienced an unprecedented and sustained increase in the number of appeals. At OMHA, for example, the number of requests for an ALJ hearing or review increased 1,222 percent, from fiscal year (FY) 2009 through FY 2014. We attribute the growth in appeals to: (1) The expanding Medicare beneficiary population
Despite significant gains in OMHA ALJ productivity (in FY 2014, each OMHA ALJ issued, on average, a record 1,048 decisions and an additional 456 dismissals, compared to an average of 471 decisions and 80 dismissals per ALJ in 2009), and CMS and OMHA initiatives to address the increasing number of appeals,
HHS has a three-prong approach to addressing the increasing number of appeals and the current backlog of claims waiting to be adjudicated at OMHA: (1) Request new resources to invest at all levels of appeal to increase adjudication capacity and implement new strategies to alleviate the current backlog; (2) take administrative actions to reduce the number of pending appeals and implement new strategies to alleviate the current backlog ; and (3) propose legislative reforms that provide additional funding and new authorities to address the volume of appeals. In this final rule, HHS is pursuing the three-prong approach by implementing rules that expand the pool of available OMHA adjudicators and improve the efficiency of the appeals process by streamlining the processes so less time is spent by adjudicators and parties on repetitive issues and procedural matters. In particular, we believe the proposals we are finalizing in section II.A.2 below to provide authority for attorneys to issue decisions when a decision can be issued without an ALJ hearing, dismissals when an appellant withdraws his or her request for an ALJ hearing, remands as provided in §§ 405.1056 and 423.2056 as finalized in this rule or at the direction of the Council, and reviews of QIC and IRE dismissals, could redirect approximately 24,500 appeals per year to attorney adjudicators, who would be able to process these appeals at a lower cost than would be required if only ALJs were used to address the same workload (see section VI below for more details regarding our estimate).
In the July 5, 2016
We received 68 timely comments on the proposed rule from individuals, organizations representing providers and suppliers, beneficiary advocacy groups, law offices, health plans, CMS contractors, and others. Summaries of the public comments and our responses to those comments are set forth below.
Council decisions are binding on the parties to that particular appeal and are the final decisions of the Secretary from which judicial review may be sought under section 205(g) of the Act, in accordance with current §§ 405.1130, 422.612(b), 423.2130, and 478.46(b). As explained in the 2009 Final Rule (74 FR 65307 through 65308), “binding” indicates the parties are obligated to abide by the adjudicator's action or decision unless further recourse is available and a party exercises that right. “Final” indicates that no further administrative review of the decision is available and judicial review may be immediately sought.
In 1999, the HHS Office of Inspector General (OIG) issued a report entitled “Medicare Administrative Appeals—ALJ Hearing Process” (OEI-04-97-00160) (Sept. 1999) (
Pursuant to section 931(a) of the MMA, HHS and SSA developed a plan for the transition of the ALJ hearing function for some types of Medicare appeals from SSA to HHS, and addressed the feasibility of precedential authority of DAB decisions. See
BIPA and MMA changes to the appeals process have now been fully implemented and we stated in the proposed rule that we believed it was appropriate to propose that select Council decisions be made precedential to increase consistency in decisions at all levels of appeal for appellants. We proposed in proposed § 401.109 to introduce precedential authority to the Medicare claim and entitlement appeals process under part 405, subpart I for Medicare fee-for-service (Part A and Part B) appeals; part 422, subpart M for appeals of organization determinations issued by MA and other competitive health plans (Part C appeals); part 423, subparts M and U for appeals of Part D prescription drug coverage determinations; and part 478, subpart B for appeals of certain QIO determinations. 81 FR 43790, 43792-43794. We proposed in § 401.109(a) that the Chair of the DAB would have authority to designate a final decision of the Secretary issued by the Council as precedential. In the proposed rule we stated that we believed this would provide appellants with a consistent body of final decisions of the Secretary upon which they could determine whether to seek appeals. We also stated it would assist appeal adjudicators at all levels of appeal by providing clear direction on repetitive legal and policy questions, and in limited circumstances, factual questions. Further, we stated that in the limited circumstances in which a precedential decision would apply to a factual question, the decision would be binding where the relevant facts are the same and evidence is presented that the underlying factual circumstances have not changed since the Council issued the precedential final decision.
We stated in the proposed rule that it is appropriate for the DAB Chair to have the role of designating select Council decisions as precedential. The DAB Chair leads the DAB, which was established in 1973. The DAB has wide jurisdiction over disputes arising under many HHS programs and components, and has issued precedential decisions for many years within several of its areas of jurisdiction. (Examples of DAB jurisdiction may be found at 45 CFR part 16, 42 CFR part 498, 42 CFR part 426, and on the DAB's Web site at
To help ensure appellants and other stakeholders are aware of Council decisions that are designated as precedential, we proposed in § 401.109(b) that notice of precedential decisions would be published in the
We proposed in § 401.109(c) to make these precedential decisions binding on all CMS components, on all HHS components that adjudicate matters under the jurisdiction of CMS, and on SSA to the extent that SSA components adjudicate matters under the jurisdiction of CMS, in the same manner
We proposed to specify the scope of the precedential effect of a Council decision designated by the DAB Chair in § 401.109(d). Specifically, we proposed that the Council's legal analysis and interpretation of an authority or provision that is binding (see, for example §§ 405.1060 and 405.1063) or owed substantial deference (see, for example § 405.1062) would be binding in future determinations and appeals in which the same authority or provision is applied and is still in effect. However, we proposed that if CMS revises the authority or provision that is the subject of a precedential decision, the Council's legal analysis and interpretation would not be binding on claims or other disputes to which the revised authority or provision applies. For example, if a Council decision designated as precedential by the DAB Chair interprets a CMS manual instruction, that interpretation would be binding on pending and future appeals and initial determinations to which that manual instruction applies. However, CMS would be free to follow its normal internal process to revise the manual instruction at issue. Once the revised instruction is issued through the CMS process, the revised instruction would apply to making initial determinations on all claims thereafter. We stated that this would help ensure that CMS continues to have the ultimate authority to administer the Medicare program and promulgate regulations, and issue sub-regulatory guidance and policies on Medicare coverage and payment.
If the decision is designated as precedential by the DAB Chair, we proposed in § 401.109(d) that the Council's findings of fact would be binding in future determinations and appeals that involve the same parties and evidence. For example, we stated in the proposed rule that if a precedential Council decision made findings of fact related to the issue of whether an item qualified as durable medical equipment (DME) and the same issue was in dispute in another appeal filed by the same party, and that party submitted the same evidence to support its assertion, the findings of fact in the precedential Council decision would be binding. However, we noted that many claim appeals turn on evidence of a beneficiary's condition or care at the time discrete items or services are furnished, and that therefore § 401.109, as proposed, is unlikely to apply to findings of fact in these appeals.
In addition, consistent with § 401.109, we proposed at § 405.968(b)(1) to add precedential decisions designated by the Chair of the Departmental Appeals Board (DAB) as an authority that is binding on the QIC. We also proposed at §§ 405.1063 and 423.2063, which currently cover the applicability of laws, regulations, and CMS Rulings, to add new paragraph (c) to the sections to provide that precedential decisions designated by the DAB Chair in accordance with § 401.109 are binding on all CMS components, all HHS components that adjudicate matters under the jurisdiction of CMS, and (in § 405.1063(c)) on the Social Security Administration to the extent that components of the Social Security Administration adjudicate matters under the jurisdiction of CMS. Finally, we proposed to add precedential decisions to the titles of §§ 405.1063 and 423.2063 to reflect the additional topic covered by proposed paragraph (c).
We received forty-eight comments on this proposal. In two instances, the same commenter submitted the same comment twice, so there were forty-six distinct comments. Among those offering comments were providers and suppliers and organizations representing them, beneficiary advocacy groups, health plan providers and administrators, and individuals. Overall, the majority of commenters supported the proposal to designate certain Council cases as precedent, but some of them made requests for clarification or modification, which we address below. Twelve commenters either opposed the proposal or suggested that it be tabled for further review. Some commenters did not take a clear position in favor of or against adoption of the proposal but offered various comments which we address below. Provided below are summaries of the specific comments received and responses to these comments:
We understand commenters' concern that stakeholders understand the considerations that will guide designation of precedential Council decisions. However, given that the variety of issues that may arise in the interpretation and application of Medicare law and policy is broad and changes rapidly, it is not practicable to articulate a comprehensive set of criteria that the DAB Chair must follow to determine which decisions are appropriate for such designation. We can, however, identify some factors that the DAB Chair may consider when
In response to the commenter's suggestion that the Council should adopt standards currently used by federal circuit courts for designating precedential decisions, we do not believe federal court standards provide the best model for criteria transferable to this internal agency administrative adjudication process. As a threshold matter, each federal circuit court establishes its own standards for designating precedent, so there is no uniform circuit court rule the Council can simply adopt. Moreover, there are substantial differences between the Medicare appeals system and the federal court system, and many factors considered by federal circuit courts in designating precedential decisions have no application in the Medicare appeals context. For example, many federal circuit courts will designate a decision as precedential if it establishes a rule of law within the circuit or creates a conflict with another circuit. Such criteria would not be applicable or helpful for the Council to consider because the Medicare appeals process is not divided into circuits. It is worth noting, however, that the factors identified in the preceding paragraph are similar to some of the factors federal circuit courts typically consider in designating precedent.
In regards to the effect of factual findings in precedential decisions, the Council's legal analysis and interpretation in a decision is applied in a specific factual context, as is also true with court decisions. That analysis and interpretation in a decision designated as precedential must be applied by decision-makers at lower levels in future cases in which the same authority or provision applies and is still in effect. If the same authority or provision would not apply in a future case because the relevant facts are not the same, the precedential decision also would not be applicable in the future case. Moreover, if CMS issues new regulatory provisions or revised policies, a precedential decision analyzing and interpreting the prior regulations or policies may not apply on review of a coverage decision made under the new regulation or policy if the relevant content of the new regulation or policy is different from that interpreted in the precedential decision.
We understand the commenters may be concerned that proposed § 401.109(d)(2) authorizes the establishment of generally applicable “factual precedent.” That proposed section, however, provides that factual findings in precedential decisions are binding only in future determinations and appeals involving the same parties, facts, and circumstances. The purpose of this provision is to discourage parties to a precedential decision from subsequently filing repetitive appeals involving the same facts in an effort to get a “second bite at the apple.” It does not mean factual findings in a precedential decision would be binding in future claims involving different facts, parties, or circumstances.
We also disagree with the assertion that the Council is not a fact-finding institution. The Council's review is de novo and based on review of the entire administrative record as compiled through the OMHA level of appeal, including review of the hearing if one was conducted, as well as all additional admissible evidence and briefings submitted to the Council. Accordingly, Council decisions properly include factual findings and, as stated above, adjudicators will take into consideration relevant factual changes when determining whether a precedential decision should apply. We disagree with the suggestion that the DAB Chair should limit the pool of precedential decisions to only those that are favorable to the beneficiary. We do not believe the DAB should take into consideration to which party the decision was favorable when designating a decision as precedential. To do so would insert bias into the selection process, which goes against the DAB's mission to provide impartial and independent review. We also disagree with the suggestion that all Council decisions involving legal analysis or interpretations of authority should have precedential effect. We understand the commenter's suggestion in this regard is to ensure consistency in the types of decisions that are designated as precedential. However, many Council decisions turn on the resolution of specific disputes of fact or on issues too unusual to have applicability or usefulness in other cases. As such, in those instances, the legal analyses or interpretations will not have widespread applicability or usefulness. We also decline to require MACs and QICs to treat prior ALJ decisions as precedential. Although there are limited circumstances where an ALJ decision may become a final decision, it is the role of the Council to issue final decisions on behalf of the Secretary. Those decisions of the Council designated as precedent will be binding on cases to which they are applicable at all lower levels of the agency adjudication process nationwide. We do not believe it would be appropriate for the decision of a single ALJ to establish precedent affecting parties nationwide without having been subject to review by the Council. Moreover, because ALJs would not be bound by each other's decisions, the decision of a MAC or QIC issued in compliance with one ALJ's decision might be reversed by a different ALJ. Therefore, making individual ALJ decisions precedential and binding on MACs and QICs would not necessarily serve the goal of increasing predictability and consistency.
Based on comments received and for the reasons we set forth, we are adding the following language to the final regulation at § 401.109(a) to include general criteria the DAB Chair may consider when selecting a Council decision as precedential, “In determining which decisions should be designated as precedential, the DAB Chair may take into consideration decisions that address, resolve, or clarify recurring legal issues, rules or policies, or that may have broad application or impact, or involve issues of public interest.”
To the extent that appellants or CMS or its contractors believe that a case may result in a decision that should be considered precedential, then the parties are free to argue so in their appeal requests or own motion referrals. In addition, the Council routinely permits parties to file briefs and other written statements pursuant to 42 CFR 405.1120, which constitutes an appropriate mechanism by which parties could argue the potential precedential status of a decision. Filing a brief in a case would also aid in the fuller development and analysis of legal issues, which may make the resulting decision a better candidate for precedential designation.
The regulations provide recourse to those appellants who do not agree with a Council's decision—judicial review. Appellants who disagree with the Council's legal interpretation or analysis in a decision may appeal the decision to federal district court in accordance with § 405.1136, regardless of whether the decision is designated as precedential. CMS also has recourse if it disagrees with a precedential decision. If CMS disagrees with the Council's legal interpretation and analysis of CMS's policy or rule, then CMS may change the policy or rule, or issue a later clarification or ruling. Given these existing mechanisms by which parties may challenge decisions on the merits or by which CMS may prospectively change policies, we do not believe it is necessary to include appeal rights or other procedures specific to challenging the designation of particular decisions as precedential.
We also decline to specify a timeframe in which the DAB Chair must designate a decision as precedential because resource and procedural constraints may limit how quickly the designation process may be completed. We do anticipate, however, that the DAB Chair will generally make the designation within a reasonable amount of time after the issuance of the decision, though as noted below, the DAB Chair may choose to wait to designate certain decisions as precedent until the time to file a request for judicial review expires. We also expect publication of the decision in the
We also recognize the possibility that an appellant may seek judicial review of a later case applying the precedential decision. If a federal court reverses a later case applying a precedential Council decision, then the effect of the court's ruling on the original precedential decision will depend on many factors, including the court's basis for reversal, whether the court remands to the Council, whether the court's decision itself is non-precedential or non-published, and whether other federal courts have issued conflicting decisions. For example, a finding by the court that the precedent was misapplied to the later case might have a different impact than a finding that the rationale underlying the precedent was erroneous. Due to the many different possibilities, we do not believe we can address in advance the possible effects of federal court decisions on later cases applying precedential Council decisions.
For the same reasons, we also do not find it appropriate to create new procedures for reversing claim denials resulting from subsequently overturned precedent. We do note, however, that the existing appeals process permits some of the relief sought. If a party believes that a denial is based on overturned precedent, then it is free to appeal the denial and make that argument before the adjudicator.
If a party believes that its claim has been inappropriately denied because of the application of a precedential decision, the party must still exhaust the administrative appeals process as statutorily required under sections 1869 and 205 of the Act. We are without authority in this rulemaking to waive statutory requirements.
We agree that it is important for CMS, its contractors, providers, beneficiaries and other stakeholders to be educated on the existence of precedential decisions and their effects on pending appeals. In order to promote consistency, CMS, OMHA and the Council have participated in joint training sessions for the past several years. We anticipate including training sessions on precedential decisions as an effective means of educating all levels of adjudicators. In addition, education sessions may also be appropriate during forums where the public participates, such as the OMHA Appellant Forum. We find it inadvisable, however, to require the Council to provide to MACs and QICs summaries of each precedential decision discussing the precedential effect of a decision and how it should be applied to future cases. The precedent arises from the Council decision itself, and creating separate summaries risks possible ambiguity or misunderstanding. While lower levels of review are bound by a legal interpretation or analysis, or certain factual findings, stated in a Council decision that has been designated as precedential, it is outside the Council's jurisdiction to instruct the review of lower-level adjudicators in cases not before the Council.
As we have noted, Council precedents do not create new law or policy and therefore do not “supplement” manuals or guidelines but may analyze, interpret, and apply them.
After review and consideration of the comments received, and for the reasons discussed above and in the proposed rule, we are finalizing the changes to §§ 405.968, 405.1063, and 423.2063 as proposed without modification, and are finalizing § 401.109 with the following modification. As discussed above, we are adding the following language to § 401.109(a) to include the general factors the DAB Chair may consider when selecting a Council decision as precedential: “In determining which decisions should be designated as precedential, the DAB Chair may take into consideration decisions that address, resolve, or clarify recurring legal issues, rules or policies, or that may have broad application or impact, or involve issues of public interest.”
As described below, we proposed changes to provide authority for attorney adjudicators to issue decisions when a decision can be issued without an ALJ conducting a hearing under the regulations, to dismiss appeals when an appellant withdraws his or her request for an ALJ hearing, to remand appeals as provided in §§ 405.1056 and 423.2056 or at the direction of the Council, and to conduct reviews of QIC
Under current §§ 405.1038 and 423.2038, OMHA ALJs are also responsible for a portion of the appeals workload that does not require a hearing because a request for an ALJ hearing may also be addressed without conducting a hearing. For example, under §§ 405.1038 and 423.2038, if the evidence in the hearing record supports a finding in favor of the appellant(s) on every issue, or if all parties agree in writing that they do not wish to appear before the ALJ at a hearing, the ALJ may issue a decision on the record without holding a hearing. Under current §§ 405.1052(a)(1) and 423.2052(a)(1), OMHA ALJs must also address a large number of requests to withdraw requests for ALJ hearings, which appellants often file pursuant to litigation settlements, law enforcement actions, and administrative agreements in which they agree to withdraw appeals and not seek further appeals of resolved claims. In addition, pursuant to §§ 405.1004 and 423.2004, OMHA ALJs review whether a QIC or IRE dismissal was in error. Under these sections, the ALJ reviews the dismissal, but no hearing is required. In FY 2015, OMHA ALJs addressed approximately 370 requests to review whether a QIC or IRE dismissal was in error. Also adding to the ALJs' workload are remands to Medicare contractors for information that can only be provided by CMS or its contractors under current §§ 405.1034(a) and 423.2034(a), and for further case development or information at the direction of the Council. Staff may identify the basis for these remands before an appeal is assigned to an ALJ and a remand order is prepared, but an ALJ must review the appeal and issue the remand order, taking the ALJ's time and attention away from hearings and making decisions on the merits of appeals.
Under section 1869(d) of the Act, an ALJ must conduct and conclude a hearing on a decision of a QIC under subsection (c). Subsection (c) of section 1869 of the Act involves the conduct of reconsiderations by QICs. We stated in the proposed rule that we believe the statute does not require the action to be taken by an ALJ in cases where there is no QIC reconsideration (for example, where the QIC has issued a dismissal), or in cases of a remand or a withdrawal of a request for an ALJ hearing, and therefore the findings of fact and conclusions of law need not be rendered. As we stated in the proposed rule, ALJ hearings are ideally suited to obtain testimony and other evidence, and hear arguments related to the merits of a claim or other determination on appeal. ALJs are highly qualified to conduct those hearings and make findings of fact and conclusions of law to render a decision in the more complex records presented with a mix of documentary and testimonial evidence. However, we stated in the proposed rule that well-trained attorneys can perform a review of the administrative record and more efficiently draft the appropriate order for certain actions, such as issuing dismissals based on an appellant's withdrawal of a request for an ALJ hearing, remanding appeals for information or at the direction of the Council, and conducting reviews of QIC and IRE dismissals.
In addition, current §§ 405.1038 and 423.2038 provide mechanisms for deciding cases without an oral hearing, based on the written record. Cases may be decided without an oral hearing when the record supports a finding in favor of the appellant(s) on every issue; all of the parties have waived the oral hearing in writing; or the appellant lives outside of the United States and did not inform the ALJ that he or she wishes to appear, and there are no other parties who wish to appear. We stated in the proposed rule that, in these circumstances, the need for an experienced adjudicator knowledgeable in Medicare coverage and payment law continues, and well-trained attorneys can review the record, identify the issues, and make the necessary findings of fact and conclusions of law when the regulations do not require a hearing to issue a decision in the appealed matter.
To enable OMHA to manage requests for ALJ hearings and requests for reviews of QIC and IRE dismissals in a more timely manner and increase service to appellants, while preserving access to a hearing before an ALJ in accordance with the statutes, we proposed to revise rules throughout part 405, subparts I and J; part 422, subpart M; part 423, subparts M and U; and part 478, subpart B, to provide authority that would allow attorney adjudicators to issue decisions when a decision can be issued without an ALJ conducting a hearing under the regulations, to dismiss appeals when an appellant withdraws his or her request for an ALJ hearing, and to remand appeals for information that can only be provided by CMS or its contractors or at the direction of the Council, as well as to conduct reviews of QIC and IRE dismissals. We also proposed to revise the rules so that decisions and dismissals issued by attorney adjudicators may be reopened and/or appealed in the same manner as equivalent decisions and dismissals issued by ALJs. As we stated in the proposed rule, allowing attorney adjudicators to issue decisions, dismissals, and remands as described above, and to conduct reviews of QIC and IRE dismissals would expand the pool of OMHA adjudicators and allow ALJs to focus on cases going to a hearing, while still providing appellants with quality reviews and decisions, dismissals, and remands. In addition, we proposed that the rights associated with an appeal adjudicated by an ALJ would extend to any appeal adjudicated by an attorney adjudicator, including any applicable adjudication time frame, escalation option, and/or right of appeal to the Council.
In addition, we noted that even if an attorney adjudicator was assigned to adjudicate a request for an ALJ hearing, that hearing request still could be reassigned to an ALJ for an oral hearing if the attorney adjudicator determined that a hearing could be necessary to render a decision. For example, if the parties waived their rights to an oral hearing in writing, allowing a decision to be issued without conducting an oral hearing in accordance with current §§ 405.1038(b)(1) or 423.2038(b)(1), but the attorney adjudicator believed testimony by the appellant or another party would be necessary to decide the appeal, the attorney adjudicator would refer the appeal to an ALJ to determine whether conducting an oral hearing would be necessary to decide the appeal regardless of the waivers, pursuant to current §§ 405.1036(b)(3) or 423.2036(b)(3). We also noted that parties to a decision that is issued without an ALJ conducting an oral hearing pursuant to current §§ 405.1038(a) or 423.2038(a) (that is, the decision is favorable to the appellant on every issue and therefore may be issued based on the record alone) continue to have a right to a hearing and a right to examine the evidence on which the decision is based and may pursue that right by requesting a review of the decision by the Council, which can remand the case for an ALJ to
To implement this proposal, we proposed to revise provisions throughout part 405 subpart I, part 422 subpart M, part 423 subparts M and U, and part 478 subpart U, as detailed in proposed revisions to specific sections and in section III of the proposed rule. In addition, we proposed to define an attorney adjudicator in § 405.902, which provides definitions that apply to part 405 subpart I, as a licensed attorney employed by OMHA with knowledge of Medicare coverage and payment laws and guidance. We also proposed to indicate in § 405.902 that the attorney adjudicator is authorized to take the actions provided for in subpart I on requests for ALJ hearing and requests for reviews of QIC dismissals. We stated that these revisions to § 405.902 would provide the public with an understanding of the attorney adjudicator's qualifications and scope of authority, and we also noted that attorney adjudicators would receive the same training as OMHA ALJs, which we note would focus on substantive areas of Medicare coverage and payment policy, as well as administrative procedures unrelated to the hearing components for which ALJs are exclusively responsible.
Provided below are summaries of the specific comments received and responses to these comments:
We received forty-seven comments on this proposal. A majority of the comments came from providers and suppliers, organizations representing providers and suppliers, beneficiary advocacy organizations, representatives, health plan providers, CMS contractors, and individuals. Twenty-nine of the commenters, mostly from the appellant community, generally supported or raised no objection to the proposal, but had requests for clarification, suggestions for modifications, and concerns or questions. Three commenters fully supported the proposal. Five commenters were equivocal. Three commenters generally supported the proposal, but opposed allowing attorney adjudicators to conduct reviews of QIC and IRE dismissals. Seven commenters opposed the proposal, including two comments from professional associations for ALJs.
In addition, §§ 405.1026 and 423.2026, as finalized in this rule, serve as important safeguards in the administrative appeals process, and provide that an ALJ or attorney adjudicator cannot adjudicate an appeal if he or she is prejudiced or partial to any party or has any interest in the matter pending for decision. This rule as finalized also provides a process that would allow a party to object to an assigned ALJ or attorney adjudicator. The objecting party would also have the opportunity to have the Council review the objections in cases where an adjudicator does not withdraw pursuant to §§ 405.1026 and 423.2026.
Under 5 U.S.C. 43 and 5 CFR 430.101, attorney adjudicators, as Federal employees, would be subject to the Performance Management Appraisal Program (PMAP), which provides for an annual performance appraisal of HHS Federal employees. ALJs are exempt from annual performance appraisals pursuant to 5 U.S.C. 4301(2)(D) and 5 CFR 430.202(b). However, the statutes
Further, the procedure for reassignment of cases from an ALJ to an attorney adjudicator, for example, where the ALJ has determined the disposition could be fully favorable to the appellants on every issue based on the record and no other party is liable for the claims at issue, will also be established by OMHA operational policies, including the OCPM. However, we note that in the scenario presented in the comment, the ALJ would also have the authority to retain assignment of the appeal and issue a decision without conducting a hearing. In the event that an ALJ determines the disposition could be fully favorable to the appellants on every issue based on the record and no other party is liable for the claims at issue and the case is reassigned to an attorney adjudicator, the ALJ will not make a record of the determination because the attorney adjudicator will make an independent assessment and will not be bound by the ALJ's determination.
With regard to unrepresented beneficiaries and enrollees, we believe they represent the most vulnerable segment of the appellant population. However, it is rare that an unrepresented beneficiary waives the right to appear at the hearing. In practice, in the few instances when this does occur, OMHA reviews the stated reason for waiving the right to appear at the hearing and may contact the unrepresented beneficiary or enrollee to confirm that the waiver is knowingly made. We believe this process will help ensure that an unrepresented beneficiary or enrollee understands the implications of waiving his or her right to appear at the hearing and the record demonstrates that understanding. In addition, we are reviewing the current form for waiving the right to appear at a hearing (form HHS-723), to determine if revisions may be necessary so users will understand that by waiving the right to appear at the hearing, the waiving party would be aware that the decision may be issued by either an ALJ or an attorney adjudicator, if no hearing is required to decide the appeal.
Sections 554 and 556 of the APA apply only to adjudications that are required by statute to be determined on the record after an opportunity for an agency hearing. In accordance with sections 1155, 1852(g)(5), 1860D-4(h), 1869(b)(1)(A), and 1876(c)(5)(B) of the Act and their implementing regulations (at 42 CFR part 405 subpart I, part 478 subpart B, part 422 subpart M, and part 423 subpart U), individuals dissatisfied with certain lower level appeal determinations are entitled to a hearing, subject to timely filing and amount in controversy limitations, to the same extent as is provided under section 205(b) of the Act. Reading these sections together, the Act directs the Secretary of Health and Human Services to provide an opportunity for a hearing regarding the right to Medicare benefits, which the Secretary has delegated to OMHA ALJs to conduct and render a decision. The rule, as finalized, is not inconsistent with the APA or the Act, but instead would augment this process by authorizing attorney adjudicators to make decisions in appeals when there is no requirement for a hearing, or in cases where parties waive the right to appear at a hearing before an ALJ and the hearing is not necessary to make a decision. The Act requires only that parties be given an opportunity for a hearing; no provision of the Act requires the Secretary to utilize an ALJ to issue a decision that does not require a hearing, for example, because the parties have waived their right to one or because no reconsideration has been issued.
Parties will continue to have an opportunity for a hearing where a reconsideration has been issued, the hearing request has been timely filed, and the amount remaining in controversy has been met. In that respect, the proposal, as finalized in this rule, does not change the process or the rights of the parties. For example, if the parties waived their rights to an oral hearing in writing, allowing a decision to be issued without conducting an oral hearing in accordance with §§ 405.1038(b)(1) or 423.2038(b)(1), but the attorney adjudicator believed testimony by the appellant or another party would be necessary to decide the appeal, the attorney adjudicator would refer the appeal to an ALJ to determine whether conducting an oral hearing would be necessary to decide the appeal regardless of the waivers, pursuant to §§ 405.1036(b)(3) or 423.2036(b)(3). In addition, parties to a decision issued without an ALJ conducting an oral hearing pursuant to §§ 405.1038(a) or 423.2038(a) continue to have a right to a hearing and a right to examine the evidence on which the decision is based, and may pursue that right by requesting review of the decision by the Council, which can remand the case for an ALJ to conduct a hearing and issue a new decision. Under the rule we are finalizing, either an attorney adjudicator or an ALJ may issue a decision when no hearing is required before an ALJ, but if a hearing is to be held, the ALJ will conduct that hearing and issue the decision. We believe this process is fully in accord with the APA and the Act.
After review and consideration of the comments received, and for the reasons discussed above and in the proposed rule, we are finalizing our proposals as discussed above without modification to provide authority for attorney adjudicators to issue decisions when a decision can be issued without an ALJ conducting a hearing under the regulations, dismissals when an appellant withdraws his or her request for an ALJ hearing, remands as provided in §§ 405.1056 and 423.2056 or at the direction of the Council, and reviews of QIC and IRE dismissals. Also, we are finalizing the definition of attorney adjudicator in § 405.902 as proposed without modification.
In addition, we are making a conforming technical revision to § 423.558(b) to replace “ALJ hearings” with “ALJ hearings and ALJ and attorney adjudicator decisions” for consistency with the revised title of part 423, subpart U, and the revisions discussed above providing for attorney adjudicator reviews.
Current § 422.562(d) states that unless subpart M regarding grievances, organization determinations and appeals under the MA program provides otherwise, the regulations found in part 405 apply under subpart M to the extent appropriate. In addition, current § 422.608, which is a section within subpart M, provides that the regulations under part 405 regarding Council review apply to the subpart to the extent that they are appropriate. Pursuant to § 417.600, these rules governing MA organization determinations are also applicable to beneficiary appeals and grievances when the beneficiary is enrolled in a competitive medical plan or HMO (also known as “cost plan”) under section 1876 of the Act; therefore our discussion of MA proceedings applies also to cost plan appeals and grievances initiated under § 417.600.
Similar to current § 422.562(d), § 478.40(c) indicates that the part 405 regulations apply to hearings and appeals under subpart B of part 478 regarding QIO reconsiderations and appeals, unless they are inconsistent with specific provisions in subpart B. Thus, the part 405 rules are used, to the extent appropriate, for administrative review and hearing procedures in the absence of specific provisions related to administrative reviews and hearing procedures in part 422, subpart M; and part 478, subpart B, respectively. These general references to part 405 are often helpful in filling in gaps in procedural rules when there is no rule on point in the respective part. However, as we stated in the proposed rule, there has been confusion on the application of part 405 rules when a part 405 rule implements a specific statutory provision that is not in the authorizing statute for the referring subpart and HHS has not adopted a similar policy for the referring subpart in its discretion to administer the MA, QIO, and cost plan appeals programs (81 FR 43795). For example, certain procedures and provisions of section 1869 of the Act (governing certain determinations and appeals under Medicare Part A and Part B) that are implemented in part 405, subpart I are different than or not addressed in sections 1155 (providing for reconsiderations and appeals of QIO determinations), 1852(g) (providing for appeals of MA organization determinations), and 1876 (providing for appeals of organization determinations made by section 1876 health maintenance organizations (HMOs) and competitive medical plans (CMPs)). Section 1869 of the Act provides for, among other things, redeterminations of certain initial determinations, QIC reconsiderations following redeterminations or expedited determinations; ALJ hearings and decisions following a QIC reconsideration; DAB review following ALJ decisions; specific time frames in which to conduct the respective adjudications; and, at certain appeal levels, the option to escalate appeals to the next level of appeal if the adjudication time frames are not met. In addition, section 1869(b)(3) of the Act does not permit providers and suppliers to introduce evidence in an appeal brought under section 1869 of the Act after the QIC reconsideration, unless there is good cause that precluded the introduction of the evidence at or before the QIC reconsideration.
In contrast, sections 1852(g)(5) of the Act and 1876(c)(5)(B) of the Act incorporate some, but not all, of the provisions of section 1869 of the Act, and add certain requirements, such as making the MAO, HMO, or CMP a party to an ALJ hearing. For example, sections 1852(g)(5) and 1876(c)(5)(B) of the Act specifically incorporate section 1869(b)(1)(E)(iii) of the Act to align the amount in controversy requirements for an ALJ hearing and judicial review among the three sections. However,
Additionally, section 1155 of the Act provides for an individual's right to appeal certain QIO reconsidered determinations made under section 1154 of the Act directly to an ALJ for hearing. However, section 1155 of the Act does not reference section 1869 of the Act or otherwise establish an adjudication time frame, and provides for a different amount in controversy requirement for an ALJ hearing.
Despite these statutory distinctions, HHS has established similar procedures by regulation to the extent practicable, when not addressed by statute. For example, section 1860D-4(h) of the Act, which addresses appeals of coverage determinations under Medicare Part D, incorporates paragraphs (4) and (5) of section 1852(g) of the Act. As discussed above, section 1852(g) does not incorporate adjudication time frames from section 1869 of the Act or otherwise establish such time frames. However, through rulemaking for Part D coverage determination appeals, HHS has adopted a 90-day adjudication time frame for standard requests for an ALJ hearing and requests for Council review of an ALJ decision, as well as a 10-day adjudication time frame when the criteria for an expedited hearing or review are met.
To clarify the application of the part 405 rules, we proposed revisions to parts 422 and 478. Specifically, we proposed in §§ 422.562(d) and 422.608 that the part 405 rules would not apply when the part 405 rule implements a statutory provision that is not also applicable to section 1852 of the Act (81 FR 43796, 43876-43877). Similarly, we proposed in § 478.40(c) that the part 405 rules would not apply when the part 405 rule implements a statutory provision that is not also applicable to section 1155 of the Act (81 FR 43890-43891). In addition, we proposed in § 478.40(c) to remove language that equates an initial determination and reconsidered determination made by a QIO to contractor initial determinations and reconsidered determinations under part 405 because that language has caused confusion with provisions that are specific to part 405 and QIC reconsiderations, and it is not necessary to apply the remaining part 405, subpart I procedural rules in part 478, subpart B proceedings. We stated in the proposed rule that, in addition to clarifying the application of part 405 rules to other parts, these revisions would help ensure that statutory provisions that are specific to certain Medicare appeals are not applied to other appeals without HHS first determining, through rulemaking, whether it would be appropriate to apply a provision and how best to tailor aligning policies for those other appeals (81 FR 43796). In our discussion of these proposals, we identified the statutory differences in sections 1155 and 1852(g) of the Act compared to section 1869 discussed above.
Provided below are summaries of the specific comments received and responses to these comments:
Proposed §§ 422.562(d), 422.608, and 478.40(c) were intended to clarify the application of part 405 rules to appeals and hearings initiated under other parts and to help ensure that statutory provisions that are specific to appeals under section 1869 of the Act are not applied to other appeals without HHS first determining, through rulemaking, whether it would be appropriate to apply a provision and how best to tailor aligning policies for those other appeals. In explaining the proposal, we also provided examples of specific provisions in section 1869 of the Act that are not also in sections 1852 and 1155 of the Act, and therefore the proposal would impact the part 405, subpart I provisions that implement those specific provisions of section 1869 of the Act that we discussed in explaining the proposal. While we believe our proposals provided sufficient information and notice regarding the part 405, subpart I provisions that would not apply in MA program appeals under part 422, subpart M and in appeals of QIO reconsidered determinations under part 478, subpart B, commenters raised concerns that the proposal and proposed regulation text were not sufficiently detailed. In response to the commenters' concerns we are finalizing §§ 422.562(d), 422.608, and 478.40(c) with modifications to specify in greater detail those part 405 provisions that implement provisions of section 1869 of the Act that are not also applicable to sections 1852 or 1155 of the Act, and that we do not believe apply to part 422, subpart M and part 478, subpart B adjudications. We specifically discussed three such provisions in section II.C of the proposed rule. The three specific topics covered by part 405, subpart I that implement provisions of section 1869 of the Act and that we believe do not apply to part 422, subpart M and part 478, subpart B adjudications are: (1) Specific time frames to conduct adjudications at each level of administrative appeal (sections 1869(a)(3)(C)(ii), (c)(3)(C)(i), (d)(1), and (d)(2) of the Act); (2) the option to request escalation of appeals when a QIC, OMHA, or the Council does not render a decision within an applicable adjudication time frame (sections 1869(c)(3)(C)(ii) and (d)(3) of the Act); and (3) the requirement that a provider or supplier, or beneficiary represented by a provider or supplier, must establish good cause to introduce evidence that was not presented at the reconsideration by the QIC (section 1869(b)(3) of the Act). Because these provisions of section 1869 of the Act were discussed in the proposed rule as examples of provisions that are not also included in sections 1852 and 1155 of the Act, and that we do not believe apply to appeals and hearings under part 422, subpart M and part 478, subpart B, and because these three areas have historically been the subject of the greatest confusion for appellants and OMHA staff regarding application of part 405 rules to other parts, we are finalizing the proposal with respect to those three areas. We will conduct additional notice and comment rulemaking if we identify additional provisions in the part 405, subpart I rules that implement provisions of section 1869 of the Act that are not also included in sections 1852(g) and 1155 of the Act, and we believe those provisions should not apply to part 422, subpart M and part 478, subpart B adjudications. Furthermore, we believe that listing the specific sections of part 405, subpart I that do not apply in MA program appeals under part 422, subpart M, and in appeals of QIO reconsidered determinations under part 478, subpart B addresses commenters' concerns regarding confusion or ambiguity.
Section 1869(d)(1)(A) of the Act provides that unless the appellant waives the statutory adjudication time frame, the ALJ conducts and concludes a hearing on a decision of the QIC and renders a decision no later than the end of the 90-day period beginning on the date a request for hearing is timely filed. In addition, section 1869(d)(2) of the Act provides that the DAB conducts and concludes a review of the decision on a hearing and renders a decision no later than the end of the 90-day period beginning on the date a request for review is timely filed. Sections 1852(g)(5) and 1155 of the Act do not contain similar adjudication time frames for an ALJ and DAB to render a decision. Therefore, we are specifying in §§ 422.562(d) and 478.40(c), and in § 422.608 through reference to § 422.562(d)(2), that the adjudication time frames at the OMHA level and the Council in part 405 do not apply in proceedings under either part 422, subpart M or part 478, subpart B. Similarly, because the part 405 escalation provisions originate in section 1869(c)(3)(C)(ii) and (d)(3) of the Act and are not incorporated into sections 1852(g) or 1155 of the Act, and the part 405 rules for adjudication time frames for an ALJ or the Council do not apply, we are specifying that the options to request escalation of an appeal in part 405 do not apply in proceedings under either part 422, subpart M or part 478, subpart B. In addition, we do not think it would be appropriate to apply the part 405, subpart I rules to time frames for adjudications below the OMHA level for Part C and QIO appeals because those parts already contain regulations regarding time frames and expediting appeals that are different from the part 405, subpart I provisions. For example, under § 422.572(f) and § 422.590(g), if an MAO fails to provide the enrollee with timely notice of an expedited organization determination or expedited reconsideration, the failure constitutes an adverse determination; the adverse decision then, respectively, is subject to appeal or must be forwarded to the IRE. With respect to OMHA-level adjudication time frames and the option to escalate an appeal from the OMHA level to the Council, we note that § 405.1016, as finalized in this rule, applies only to requests for a hearing filed after a QIC has issued a reconsideration. In the final rule establishing the MA program, CMS stated that part 405 regulatory provisions that are dependent upon QICs would not apply to part 422, subpart M adjudications because an IRE—not a QIC—conducts reconsiderations for MA appeals (70 FR 4588, 4676). We believe the same rationale extends to reconsiderations conducted by a QIO under part 478, subpart B. We also believe it is unwise to extend the adjudication time frames to additional cases or to create an option for escalation of an appeal where such provisions are not required by statute given the current volume of pending appeals at OMHA and the Council. However, we note that the vast majority of MA and QIO appeals are filed by beneficiaries and enrollees, and current OMHA and Council policy provides for the prioritization of appeals filed by beneficiaries or enrollees. Thus, we anticipate that there will be little change in adjudicatory processing times for most appellants in MA program appeals and appeals of QIO reconsidered determinations. Accordingly, we do not believe that the policies we are finalizing above will take away current
In addition, section 1869(b)(3) of the Act states that a provider or supplier may not introduce evidence in any appeal that was not presented at the QIC reconsideration unless there is good cause that precluded the introduction of such evidence at or before that reconsideration. Several provisions in part 405 implement this limitation on the submission of new evidence by providers and suppliers, as well as beneficiaries represented by providers and suppliers, and further implement rules for the review of whether good cause exists for late submissions. Neither section 1852(g)(5) nor section 1155 of the Act contains a similar limitation on the submission of new evidence by providers and suppliers if such evidence was not presented at an earlier stage in the appeal proceedings. Furthermore, the requirement to show good cause for the introduction of new evidence applies to evidence that was not presented at the QIC reconsideration and, as noted above, part 405 provisions that are dependent upon QICs do not apply to adjudications under part 422, subpart M, and we believe the same rationale extends to reconsiderations conducted by QIOs under part 478, subpart B. Therefore, we are specifying in §§ 422.562(d) and 478.40(c), and in § 422.608 through reference to § 422.562(d)(2), that the good cause limitations on new evidence submitted by providers, suppliers, and beneficiaries represented by a provider or supplier, outlined in part 405, subpart I do not apply in proceedings under part 422, subpart M or part 478, subpart B. Although two commenters expressed concern that the proposals could mean that an enrollee in the MA program would not be able to invoke the protection of current § 405.1018(d), these finalized rules specifically identify §§ 405.1018(c), 405.1028(a), and 405.1122(c) as part 405 sections that do not apply in part 422, subpart M, and therefore the protections afforded to unrepresented beneficiaries in current § 405.1018(d) are unnecessary in part 422, subpart M appeals because there is no need for any appellant in a Part C appeal to show good cause for the introduction of new evidence for the first time at the OMHA level. As we stated above, we do not believe that the policies we are finalizing will take away current protections or safeguards for beneficiaries appealing an MA organization determination (or cost plan determination) or appealing from a QIO determination.
After review and consideration of the comments received, for the reasons discussed above and in the proposed rule, we are finalizing the following changes to §§ 422.562(d), 422.608, and 478.40(c). We are specifying in §§ 422.562(d) and 478.40(c), and in 422.608 through reference to § 422.562(d)(2), those specific provisions of part 405, subpart I discussed in the proposed rule that are not applicable to MA program appeals under part 422, subpart M or appeals of QIO reconsidered determinations under part 478, subpart B, as discussed above. The provisions we are specifying are: (1) § 405.950 (time frames for making a redetermination); (2) § 405.970 (time frame for making a reconsideration following a contractor redetermination, including the option to escalate an appeal to the OMHA level); (3) § 405.1016 (time frames for deciding an appeal of a QIC reconsideration or escalated request for a QIC reconsideration, including the option to escalate an appeal to the Council); (4) The option to request that an appeal be escalated from the OMHA level to the Council as provided in § 405.1100(b) and the time frames for the Council to decide an appeal of an ALJ's or attorney adjudicator's decision or an appeal that is escalated from the OMHA level to the Council as provided in § 405.1100(c) and (d); (5) § 405.1132 (request for escalation to Federal court); and (6) §§ 405.956(b)(8), 405.966(a)(2), 405.976(b)(5)(ii), 405.1018(c), 405.1028(a), and 405.1122(c) and any other references to requiring a determination of good cause for the introduction of new evidence by a provider, supplier, or a beneficiary represented by a provider or supplier.
When the 2005 Interim Final Rule was published in March 2005, implementing the part 405, subpart I rules, OMHA was not yet in operation. Further, processes and procedures were being established under the part 405 subpart I rules, with new CMS contractors and the newly transitioned ALJ hearing function. Since that time, OMHA and CMS and its contractors have developed operating arrangements to help ensure appeals flow between CMS contractors and OMHA, and that appeal instructions for appellants provide clear direction on how and where to file requests for hearings and reviews. However, many of the current rules for the ALJ hearing program that OMHA administers reflect the transition that was occurring at the time of the 2005 Interim Final Rule, and OMHA is not mentioned in the regulation text.
To provide clarity to the public on the role of OMHA in administering the ALJ hearing program, and to clearly identify where requests and other filings should be directed, we proposed to define OMHA in § 405.902 as the Office of Medicare Hearings and Appeals within the U.S. Department of Health and Human Services, which administers the ALJ hearing process in accordance with section 1869(b)(1) of the Act. We also proposed to amend rules throughout part 405, subparts I and J; part 422, subpart M; part 423, subparts M and U; and part 478, subpart B to reference OMHA or an OMHA office, in place of current references to an unspecified entity, ALJs, and ALJ hearing offices, when a reference to OMHA or an OMHA office provides a clearer explanation of a topic. To implement these changes, we proposed to revise provisions throughout part 405 subparts I and J, part 422 subpart M, part 423 subparts M and U, and part 478 subpart U, as detailed in proposed revisions to specific sections in section III of the proposed rule.
Provided below are summaries of the specific comments received and responses to these comments:
After review and consideration of the comments received, for the reasons discussed above and in the proposed rule, we are finalizing our proposals without modification to define OMHA and replace certain references to ALJs, ALJ hearing offices, and unspecified entities with a reference to OMHA or an OMHA office.
The Council is currently referred to as the “MAC” throughout current part 405, subpart I; part 422, subpart M; and part 423, subparts M and U. This reference has caused confusion in recent years with the transition from Fiscal Intermediaries and Carriers, to Medicare administrative contractors—for which the acronym “MAC” is also commonly used—to process claims and make initial determinations and redeterminations in the Medicare Part A and Part B programs. In addition, current §§ 422.618 and 422.619 reference the Medicare Appeals Council but use “Board” as the shortened reference, and part 478, subpart B, references the DAB as the reviewing entity for appeals of ALJ decisions and dismissals but the Council is the entity that conducts reviews of ALJ decisions and dismissals, and issues final decisions of the Secretary for Medicare appeals under part 478, subpart B.
To address potential confusion with references to Medicare administrative contractors and align references to the Council as the reviewing entity for appeals of ALJ decisions and dismissals throughout part 405, subpart I; part 422, subpart M; and part 423, subparts M and U, we proposed to amend the following rules to replace “MAC” or “Board” with “Council”: §§ 405.902, 405.904, 405.906, 405.908, 405.910, 405.926, 405.980, 405.982, 405.984, 405.990, 405.1026, 405.1036, 405.1037, 405.1042, 405.1046, 405.1048, 405.1050, 405.1052, 405.1054, 405.1060, 405.1062, 405.1063, 405.1100, 405.1102, 405.1104 (as re-designated and revised as proposed § 405.1016(e)-(f)), 405.1106, 405.1108, 405.1110, 405.1112, 405.1114, 405.1116, 405.1118, 405.1120, 405.1122, 405.1124, 405.1126, 405.1128, 405.1130, 405.1132, 405.1134, 405.1136, 405.1138, 405.1140, 422.561, 422.562, 422.608, 422.612, 422.616, 422.618, 422.619, 422.622, 422.626, 423.560, 423.562, 423.1968, 423.1974, 423.1976, 423.1978, 423.1980, 423.1982, 423.1984, 423.1990, 423.2026, 423.2036, 423.2042, 423.2046, 423.2048, 423.2050, 423.2052, 423.2054, 423.2062, 423.2063, 423.2100, 423.2102, 423.2106, 423.2108, 423.2110, 423.2112, 423.2114, 423.2116, 423.2118, 423.2120, 423.2122, 423.2124, 423.2126, 423.2128, 423.2130, 423.2134, 423.2136, 423.2138, and 423.2140.
In addition, to align references to the Council as the reviewing entity for appeals of ALJ decisions and dismissals in part 478, subpart B, we proposed to amend §§ 478.46 and 478.48 to replace “Departmental Appeals Board” and “DAB,” with “Medicare Appeals Council” and “Council”.
Provided below are summaries of the specific comments received and responses to these comments:
After review and consideration of the comments received, for the reasons discussed above and in the proposed rule, we are finalizing our proposals without modification to replace references to “MAC” and “Board,” with “Council” in the sections listed above, and to replace references to “Departmental Appeals Board” and “DAB” with “Medicare Appeals Council” and “Council” in §§ 478.46 and 478.48. In addition to the sections listed above, we are also making a conforming technical revision to § 423.558(b) to replace the reference to “MAC” in § 423.558(b) with “Council.”
Part 405, subpart I and part 423, subpart U contain detailed procedures for requesting and adjudicating a request for an ALJ hearing, and a request for a review of a QIC or IRE dismissal. Part 423, subpart U provisions were proposed in the March 17, 2008
Current § 423.562(b)(4) lists the appeal rights of a Part D plan enrollee, if the enrollee is dissatisfied with any part of a coverage determination. Specifically, paragraph (b)(4)(v) describes the right to request Council review of the ALJ's hearing decision if the ALJ affirms the IRE's adverse coverage determination in whole or in part, and paragraph (b)(4)(vi) describes the right to judicial review of the hearing decision if the Council affirms the ALJ's adverse coverage determination in whole or in part, and the amount in controversy requirements are met. We proposed revisions to paragraphs (b)(4)(v) and (vi) to account for the possibility that an appeal at the OMHA level could be decided by an attorney adjudicator or by an ALJ without conducting a hearing. 81 FR 43790, 43797. We proposed to revise paragraph (b)(4)(v) to insert “or attorney adjudicator” after each instance of “the ALJ.” We stated in the proposed rule that this proposal was necessary to implement the proposal to allow attorneys to adjudicate requests for an ALJ hearing when no hearing is
In paragraph (b)(4)(vi), we proposed to remove “ALJ's” and insert “ALJ's or attorney adjudicator's” in its place to implement the proposal to allow attorneys to adjudicate requests for an ALJ hearing when no hearing is conducted as proposed in section II.B of the proposed rule (and discussed in section II.A.2 above), by including an attorney adjudicator's decision as a decision that may be affirmed by the Council. We also proposed to remove “hearing” before “decision” in paragraph (b)(4)(vi) because while the Council may conduct a hearing, Council decisions are generally issued without conducting a hearing, and the decision of the Council is subject to judicial review.
We received no comments on these proposals, other than comments discussed in section II.A.2 above related to our general proposals to provide authority for attorney adjudicators to issue certain decisions, dismissals and remands, and to revise the rules so that decisions and dismissals issued by attorney adjudicators may be reopened and/or appealed in the same manner as equivalent decisions and dismissals issued by ALJs. Accordingly, for the reasons discussed above and in the proposed rule, we are finalizing these changes to § 423.562 as proposed without modification.
The current heading of part 423, subpart U references ALJ hearings but does not reference decisions. We proposed to revise the heading by replacing “ALJ Hearings” with “ALJ hearings and ALJ and attorney adjudicator decisions” to reflect that subpart U covers decisions by ALJs and attorney adjudicators, as proposed in section II.B of the proposed rule (and discussed in section II.A.2 above). 81 FR 43790, 43797.
Current § 423.1968 explains the scope of the requirements in subpart U. We proposed in § 423.1968 to expand the scope of subpart U to include actions by attorney adjudicators, as proposed in section II.B of the proposed rule (and discussed in section II.A.2 above). 81 FR 43790, 43797. Specifically, we proposed at § 423.1968(a) to add that subpart U sets forth requirements relating to attorney adjudicators with respect to reopenings; at § 423.1968(b) to add that subpart U sets forth requirements relating to ALJ decisions and decisions of attorney adjudicators if no hearing is conducted; and at § 423.1968(d) to add that subpart U sets forth the requirements relating to Part D enrollees' rights with respect to ALJ hearings and ALJ or attorney adjudicator reviews. We stated that these changes are necessary to accurately describe the scope of the revised provisions of subpart U to implement the attorney adjudicator proposal discussed in section II.B of the proposed rule and II.A.2 of this final rule above.
We received no comments on these proposals, other than comments discussed in section II.A.2 above related to our general proposals to provide authority for attorney adjudicators to issue certain decisions, dismissals and remands, and to revise the rules so that decisions and dismissals issued by attorney adjudicators may be reopened and/or appealed in the same manner as equivalent decisions and dismissals issued by ALJs. Accordingly, for the reasons discussed above and in the proposed rule, we are finalizing these changes to § 423.1968 as proposed without modification.
Section 405.904(a) provides a general overview of the entitlement and claim appeals process to which part 405, subpart I applies. Current paragraphs (a)(1) and (a)(2) provide that if a beneficiary obtains a hearing before an ALJ and is dissatisfied with the decision of the ALJ, the beneficiary may request that the Council review the case. To provide for the possibility that a decision may be issued without conducting a hearing by an ALJ, as permitted under current rules, or an attorney adjudicator, as proposed in II.B of the proposed rule (and discussed in section II.A.2 of this final rule above), we proposed to add language in paragraphs (a)(1) and (a)(2) to provide that if the beneficiary is dissatisfied with the decision of an ALJ or attorney adjudicator when no hearing is conducted, the beneficiary may request that the Council review the case. We stated in the proposed rule that this would provide a comprehensive overview of the entitlement and claim appeals process, with information on the potential for and right to appeal decisions by ALJs when no hearing is conducted, and the right to appeal decisions by attorney adjudicators. 81 FR 43790, 43797.
Provided below is a summary of the specific comment received and our response to this comment:
After review and consideration of the comment received, for the reasons discussed above and in the proposed rule, we are finalizing these changes to § 405.904 as proposed, with the following modifications. We are removing “Administrative Law Judge (ALJ)” and “Medicare Appeals Council (Council)” from paragraph (a)(1) and adding “ALJ” and “Council” in their places, respectively, for consistency with the rest of part 405, subpart I and because the term “ALJ” is already defined in § 405.902.
Section 405.906 discusses parties to the appeals process and subsection (b) addresses parties to the redetermination, reconsideration, hearing and MAC. We proposed in the paragraph heading and introductory text to subsection (b) to replace the phrases “hearing and MAC” and “hearing, and MAC review,” respectively, with “proceedings on a request for hearing, and Council review” because, absent an assignment of appeal rights, the parties are parties to all of the proceedings on a request for hearing, including the hearing if one is conducted, and they are parties to the Council's review. 81 FR 43790, 43797.
We received no comments on this proposal, other than comments in support of our general proposals to replace references to “MAC” and “Board,” with “Council,” and to replace references to “Departmental Appeals Board” and “DAB” with “Medicare Appeals Council” and “Council,” as
Section 405.908 discusses the role of Medicaid State agencies in the appeals process and states that if a State agency files a request for redetermination, it may retain party status at the QIC, ALJ, MAC and judicial review levels. We proposed to replace “ALJ” with “OMHA” to provide that the State agency has party status regardless of the adjudicator assigned to the State agency's request for an ALJ hearing or request for review of a QIC dismissal at the OMHA level of review, as attorney adjudicators may issue decisions on requests for hearing and adjudicate requests for reviews of QIC dismissals, as proposed in section II.B of the proposed rule (and discussed in section II.A.2 above). 81 FR 43790, 43797-43798.
Provided below is a summary of the specific comment received and response to the comment:
After review and consideration of the comment received, for the reasons discussed above and in the proposed rule, we are finalizing these changes to § 405.908 as proposed without modification.
As described below, we proposed a number of revisions to the rules in § 405.910 concerning the appointment of a representative to act on behalf of an individual or entity in exercising his or her right to an initial determination or appeal. 81 FR 43790, 43798-43799. The 2002 Proposed Rule (67 FR 69318 through 69319) explained that the § 405.910 requirements for a valid appointment of a representative are necessary to help ensure that adjudicators are sharing and disseminating confidential information with the appropriate individuals. The 2005 Interim Final Rule (70 FR 11428 through 11431) adopted a general requirement to include a beneficiary's health insurance claim number (HICN) for a valid appointment of a representative in § 405.910(c)(5). The SMART Act Final Rule (80 FR 10614, 10617) revised § 405.910(c)(5) to explicitly limit the requirement to include a beneficiary's HICN to instances in which the beneficiary is the party appointing a representative. However, the Medicare manual provision for completing a valid appointment of representative (Medicare Claims Processing Manual (Internet-Only Manual 100-4), chapter 29, section 270.1.2) details the requirements for an appointment of representation to contain a unique identifier of the party being represented. Specifically, if the party being represented is the beneficiary, the Medicare number must be provided, and if the party being represented is a provider or supplier, the National Provider Identifier (NPI) number should be provided. Additionally, the official form for executing a valid appointment of representative (form CMS-1696 (OMB No. 0938-0950), available at
Section 405.910 also addresses defective appointments, and delegations and revocations of appointments. However, there has been confusion on the effects on the adjudication of an appeal when a defective appointment must be addressed, or when an adjudicator is not timely informed of a delegation or revocation of an appointment. To address the effect of a defective appointment on the adjudication of an appeal to which an adjudication time frame applies, we proposed to add § 405.910(d)(3), which would extend an applicable adjudication time frame from the later of (1) the date that a defective appointment of representative was filed or (2) the date the current appeal request was filed by the prospective appointed representative, to the date that the defect in the appointment was cured or the party notifies the adjudicator that he or she will proceed with the appeal without a representative. We proposed this revision because, in accordance with § 405.910(d)(1) and (d)(2), a prospective appointed representative lacks the authority to act on behalf of a party and is not entitled to obtain or receive any information related to the appeal. Thus, contact with the party may be necessary to obtain missing information from the appointment, which may delay adjudicating the appeal until the appointment is cured or the party decides to proceed with the appeal without a representative. However, we proposed that if the request was filed by a prospective
We also proposed at § 405.910(f)(1) to replace “ALJ level” with “OMHA level” so there would be no confusion that proceedings at the OMHA level are considered proceedings before the Secretary for purposes of appointed representative fees, regardless of whether the case is assigned to an ALJ or attorney adjudicator.
Section 405.910(i)(2) and (i)(3) provide that if an appeal involves an appointed representative, an ALJ sends notices of actions or appeal decisions, and requests for information or evidence regarding a claim that is appealed to the appointed representative. We proposed to insert “or attorney adjudicator” after “ALJ” in § 405.910(i)(2) and (i)(3). This would provide that attorney adjudicators, as proposed in section II.B of the proposed rule (and discussed in section II.A.2 of this final rule above), like an ALJ under the current provisions, would send notices of actions or appeal decisions, and requests for information or evidence regarding a claim that is appealed to the appointed representative.
A representative and/or the represented party is responsible for keeping the adjudicator of a pending appeal current on the status of the representative. In practice, sometimes adjudicators are not informed of a delegation or revocation of an appointment of representative that has been filed for an appeal, which results in confusion and potentially duplicative or unnecessary proceedings. We proposed to revise § 405.910(l)(2) (which, as described later, we proposed to re-designate as (l)(1)(ii)) to add that a delegation is not effective until the adjudicator receives a copy of the party's written acceptance of the delegation, unless the representative and designee are attorneys in the same law firm or organization, in which case the written notice to the party of the delegation may be submitted if the acceptance is not obtained from the party. This revision would emphasize the importance of keeping adjudicators current on the status of the representative and also state the effects of failing to do so. The revisions we proposed to § 405.910(l)(2) (re-designated as proposed (l)(1)(ii)) would also serve to assist adjudicators in sharing and disseminating confidential information only with appropriate individuals, and to provide adjudicators with appropriate contact information for scheduling purposes. To accommodate proposed paragraph (l)(2), we proposed to re-designate current paragraph (l), except for the title of the paragraph, as paragraph (l)(1), and to also re-designate the current subparagraphs accordingly. In addition, we proposed to add a missing “by” in current paragraph (l)(1)(ii) (re-designated as (l)(1)(i)) of § 405.910 to indicate that a designee accepts to be obligated “by” and comply with the requirements of representation. We also proposed to revise language in current paragraph (l)(2) (re-designated as proposed (1)(l)(ii)) of § 405.910 to clarify that “this signed statement” refers to the “written statement signed by the party,” and the written statement signed by the party is not required when the appointed representative and designee are attorneys in the same law firm or organization and the notice of intent to delegate under paragraph (l)(1)(i) indicates that fact. To further emphasize the importance of keeping adjudicators current on the status of the representative and clarify the effects of failing to do so, we also proposed to add at § 405.910(l)(3) and (m)(4) that a party's or representative's failure to notify the adjudicator that an appointment of representative has been delegated or revoked, respectively, is not good cause for missing a deadline or not appearing at a hearing.
We did not propose any changes for part 423, subpart U because it does not have a corresponding provision for representative appointments.
Provided below are summaries of the specific comments received and responses to these comments:
Consistent with existing Medicare manual provisions found in chapter 29, section 270.1.2 of the Medicare Claims Processing Manual (Internet-Only Manual 100-4), § 405.910(c)(5), as finalized in this rule, expressly requires that when a provider or supplier is the party appointing a representative, the provider's or supplier's NPI must be provided in order to create a valid appointment, and a physician is included in the § 405.902 definition of supplier. We thank the commenters for the suggestion to revise form CMS-1696, and may consider the suggestion for potential future clarification to the form. However, we note that the regulation is the binding authority, and parties wishing to appoint a representative must comply with the requirements of § 405.910.
With respect to the second comment, the commenter is correct that form CMS-1696 does not currently address appointment of a representative by a health plan. The MAO is a party to a Part C MA appeal, and an applicable plan (which may be a health plan) may be a party to an appeal involving a Medicare Secondary Payer (MSP) overpayment recovery assessed against the applicable plan. Although the form does not currently address health plans, health plans may use form CMS-1696, instead of a providing a separate notice that complies with § 405.910(c). However, in our experience, the individuals who file an appeal or appear at a hearing on behalf of health plans are generally employees of the plan, including medical directors, physician or nurse advisors, regulatory analysts, or in-house counsels. Indeed, this appears consistent with the commenter's request for a space to indicate whether the “representative” will be attending as a witness, representative, or medical expert. An appointment of representation under § 405.910 is not necessary where an individual who is employed by the plan is the person filing the appeal or appearing on behalf of the plan, and a representative, as that term is used in § 405.910, generally does not serve as a witness or medical expert in an appeal. Nevertheless, there may be instances where a health plan or applicable plan wishes to appoint a non-employee representative. In these instances § 405.910(a) is clear that any party to an appeal may appoint a representative. We note, however, that health plans and applicable plans that opt to use form CMS-1696 to appoint a representative would not have HICNs or NPIs, and would not need to complete that box, and we did not propose to require that another unique identifier be included in appointments of representative where a health plan or applicable plan is the party being represented.
After review and consideration of the comments received, for the reasons
Current § 405.926(l) provides that an ALJ's decision to reopen or not to reopen a decision is not an initial determination, and in accordance with the introductory language of § 405.926, is therefore not appealable under subpart I. In section III.A.2.l of the proposed rule, we proposed to revise the reopening rules to provide that attorney adjudicators would have the authority to reopen their decisions to the same extent that ALJs may reopen their decisions under the current provisions. We proposed to insert “or attorney adjudicator's” after “ALJ's” in § 405.926(l) to provide that the attorney adjudicator's decision to reopen or not reopen a decision also is an action that is not an initial determination and therefore not an appealable action under subpart I. 81 FR 43790, 43799.
Current § 405.926(m) provides that a determination that CMS or its contractors may participate in or act as parties in an ALJ hearing is not an initial determination, and in accordance with the introductory language of § 405.926, is therefore not appealable under subpart I. As explained in section III.A.3.f of the proposed rule and II.B.3.f of this final rule below, we proposed to revise § 405.1010, which currently discusses when CMS or a contractor may participate in an ALJ hearing. As explained in the proposal to revise § 405.1010, CMS or a contractor may elect to participate in the proceedings on a request for an ALJ hearing for which no hearing is conducted, in addition to participating in an ALJ hearing as a non-party participant. To align with our proposed revision to § 405.1010, we proposed to revise § 405.926(m) to indicate that CMS or its contractors may participate in the full scope of the proceedings on a request for an ALJ hearing, including the hearing, by replacing “participate in or act as parties in an ALJ hearing,” with “participate in the proceedings on a request for an ALJ hearing or act as parties in an ALJ hearing.” 81 FR 43790, 43799.
We received no comments on these proposals, other than: (1) Comments discussed in section II.A.2 of the final rule above related to our general proposals to provide authority for attorney adjudicators to issue certain decisions, dismissals and remands, and to revise the rules so that decisions and dismissals issued by attorney adjudicators may be reopened and/or appealed in the same manner as equivalent decisions and dismissals issued by ALJs; and (2) comments discussed in sections III.A.3.f.i through III.A.3.f.iii of this final rule below related to our proposals regarding CMS and CMS contractors as participants or parties in the adjudication process. Accordingly, for the reasons discussed above and in the proposed rule, we are finalizing these changes to § 405.926 as proposed without modification.
Current § 405.956(b)(8) requires that the notice of a redetermination include a statement that evidence not submitted to the QIC is not considered at an ALJ hearing or further appeal, unless the appellant demonstrates good cause as to why that evidence was not provided previously. We proposed to remove “an ALJ hearing” and add “the OMHA level” in its place so that the notice of a redetermination is clear that, absent good cause and subject to the exception in § 405.956(d) for beneficiaries not represented by a provider or supplier, evidence that was not submitted to the QIC is not considered by an ALJ or an attorney adjudicator, as defined in section II.B of the proposed rule and II.A.2 of this final rule above. 81 FR 43790, 43799.
We received no comments on this proposal, other than comments discussed in section II.A.2 of this final rule above related to our general proposals to provide authority for attorney adjudicators to issue certain decisions, dismissals and remands, and to revise the rules so that decisions and dismissals issued by attorney adjudicators may be reopened and/or appealed in the same manner as equivalent decisions and dismissals issued by ALJs. Accordingly, for the reasons discussed above and in the proposed rule, we are finalizing these changes to § 405.956 as proposed without modification.
As discussed in the 2005 Interim Final Rule (70 FR 11444 through 11445) and the 2009 Final Rule (74 FR 65311 through 65312), HHS adopted a policy of providing for one level of administrative review of a dismissal of a request for appeal. As a result, an adjudicator's decision or dismissal when reviewing a dismissal action issued at the previous level is binding and not subject to further review. The policy balances a party's need for review and the need for administrative finality. The policy is embodied in the rules relating to reviews of dismissals at the next adjudicative level in §§ 405.972(e), 405.974(b)(3), 405.1004(c), 405.1102(c), 405.1108(b), and 405.1116.
At the QIC level of appeal, a review of a contractor redetermination and a review of a contractor's dismissal of a request for a redetermination are both characterized as a “reconsideration.” While the outcome of a QIC's reconsideration of a contractor dismissal is differentiated and further reviews are not permitted in accordance with § 405.974(b)(3), an ambiguity exists with regard to the time frame for completing this type of reconsideration and escalation options when that time frame is not met. Current § 405.970 establishes the time frame for making a reconsideration without further qualification. However, section 1869(b)(1)(D)(i) of the Act establishes that a right to a reconsideration of an initial determination (which includes a redetermination under section 1869(a)(3)(D) of the Act) exists if a timely request for a reconsideration is filed within 180 days following receipt of a contractor's redetermination, which is discussed in § 405.962. In contrast, § 405.974(b)(1) requires that a request for a QIC reconsideration of a contractor's dismissal of a request for redetermination be filed within 60 calendar days after receiving the contractor's notice of dismissal. Section 1869 of the Act does not address dismissals. Rather, section 1869(c)(3)(C)(i) and (c)(3)(C)(ii) of the Act only provide for a time frame to complete a reconsideration of an initial determination, and an option to escalate a case if that time frame is not met.
The effect of the ambiguity in § 405.970 is the potential escalation of a request for a QIC reconsideration of a contractor's dismissal when the reconsideration is not completed within 60 calendar days of a timely filed request for a reconsideration of the dismissal, and a potential hearing being required in accordance with § 405.1002(b). The potential effect of this ambiguity is contrary to the policy of limiting reviews of dismissals to the next adjudicative level of administrative appeal, as well as the statutory construct for providing ALJ hearings after QIC reconsiderations of redeterminations, or escalations of requests for reconsiderations following a redetermination. We also note that in the parallel context of an ALJ review of
To address this unintended outcome of § 405.970, we proposed to amend the title of § 405.970 and paragraphs (a), (b)(1), (b)(2), (b)(3), (c), (e)(1), and (e)(2)(i) to provide that the provisions would only apply to a request for a reconsideration following a contractor redetermination, and not to a request for QIC review of a contractor's dismissal of a request for redetermination. We stated in the proposed rule that these revisions would further our policy on reviews of dismissals and help appellants better understand what may be escalated to OMHA for an ALJ hearing. We also proposed to replace “the ALJ hearing office” in current paragraph (e)(2)(ii) with “OMHA” because the QIC sends case files for escalated cases to a centralized location, not to individual field offices. We did not propose any parallel changes for part 423 because subpart U does not address IRE reconsiderations and subpart M does not have a provision with the same ambiguity. 81 FR 43790, 43799-43800.
To provide additional clarity to the procedures for reviews of dismissal actions, we also proposed to amend the text in §§ 405.972(b)(3), (e) and 405.974(b)(3), and the introductory text of § 405.974(b) to replace the references to a “reconsideration” of a contractor's dismissal of a request for redetermination with the word “review” so that the QIC's action is referred to as a review of a contractor's dismissal of a request for redetermination. We also proposed to revise the section heading of § 405.972 to read “Withdrawal or dismissal of a request for reconsideration or review of a contractor's dismissal of a request for redetermination,” and the section heading of § 405.974 to read, “Reconsideration and review of a contractor's dismissal of a request for redetermination.” We stated in the proposed rule that these revisions are consistent with the description of a reconsideration in section 1869(c)(3)(B)(i) of the Act and § 405.968(a). As we stated in the proposed rule, a QIC's review of a contractor dismissal action is limited to the appropriateness of the dismissal action and does not consist of a review of the initial determination and redetermination, which is the meaning attributed to a reconsideration. In reviewing a contractor dismissal action, the QIC either affirms or vacates the dismissal of the request for redetermination. If a dismissal action is vacated, the appeal is remanded back to the MAC to conduct a redetermination on the merits (§ 405.974). 81 FR 43790, 43800.
Current § 405.972(e) provides that a QIC's dismissal of a request for reconsideration is binding unless it is modified or reversed by an ALJ under § 405.1004. As discussed in section II.B of the proposed rule and II.A.2 of this final rule above, we proposed that an attorney adjudicator may conduct a review of a QIC's dismissal of a request for reconsideration and in section III.A.3.c of the proposed rule (discussed in section II.B.3.c of this final rule below), we proposed to revise § 405.1004 to provide the effect of an attorney adjudicator's action taken in reviewing the QIC dismissal is equivalent to the effect of an ALJ's action taken in reviewing the QIC dismissal. To align with our proposed revision to § 405.1004, we proposed to insert “or attorney adjudicator” after “an ALJ” in § 405.972(e) to indicate that a QIC's dismissal of a request for reconsideration is binding unless it is modified or reversed by an ALJ or attorney adjudicator under § 405.1004. 81 FR 43790, 43800.
We received no comments on these proposals, other than: (1) Comments discussed in section II.A.2 above related to our general proposals to provide authority for attorney adjudicators to issue certain decisions, dismissals and remands, and to revise the rules so that decisions and dismissals issued by attorney adjudicators may be reopened and/or appealed in the same manner as equivalent decisions and dismissals issued by ALJs; and (2) comments discussed in section II.A.4 above related to our general proposal to reference OMHA or an OMHA office, in place of current references to an unspecified entity, ALJs, and ALJ hearing offices, when a reference to OMHA or an OMHA office provides a clearer explanation of a topic. Accordingly, for the reasons discussed above and in the proposed rule, we are finalizing these changes to §§ 405.970, 405.972, and 405.974 as proposed without modification.
Section 1869(b)(3) of the Act states that a provider or supplier may not introduce evidence in any appeal that was not presented at the reconsideration conducted by a QIC unless there is good cause as to why the evidence was not provided prior to the issuance of the QIC's reconsideration. Under this authority, § 405.976(b)(5)(ii) provides that a notice of reconsideration must include a summary of the rationale for the reconsideration that specifies that all evidence that is not submitted prior to the issuance of the reconsideration will not be considered at the ALJ level, or made part of the administrative record, unless the appellant demonstrates good cause as to why the evidence was not provided prior to the issuance of the QIC's reconsideration; however, it does not apply to a beneficiary unless the beneficiary is represented by a provider or supplier or to state Medicaid agencies. The statement that the evidence will not be made part of the administrative record is inconsistent with our practice of making a complete record of the administrative proceedings for further reviews, including documents submitted by parties that were not considered in making the decision. Current § 405.1028(c) states that if good cause does not exist, the ALJ must exclude the evidence from the proceedings and may not consider it in reaching a decision. However, it does not instruct the ALJ to remove the evidence from the administrative record, and to do so would preclude an effective review of the good cause determination. In addition, we noted in the 2005 Interim Final Rule (70 FR 11464) that under current § 405.1042(a)(2), excluded evidence is part of the record because it states that in the record, the ALJ must also discuss any evidence excluded under § 405.1028 and include a justification for excluding the evidence. To help ensure that the evidence is preserved in the administrative record, we proposed to delete “or made part of the administrative record” from the paragraph in § 405.976(b)(5)(ii). 81 FR 43790, 43800.
Current § 405.976(b)(7) requires that the QIC notice of reconsideration contain a statement of whether the amount in controversy needed for an ALJ hearing is met when the reconsideration is partially or fully unfavorable. As further discussed in section III.A.3.d of the proposed rule and II.B.3.d of the final rule below, we proposed revisions to § 405.976(b)(7) along with revisions to the methodology for calculating the amount in controversy required for an ALJ hearing under § 405.1006(d) to better align the
We did not propose any changes to part 423 because subpart U does not address IRE reconsiderations and subpart M does not contain similar provisions.
Provided below are summaries of the specific comments received and responses to these comments:
We proposed at § 405.1028(a)(2)(i) through (v) to include specific instances when an ALJ or attorney adjudicator may find good cause for the introduction of new evidence submitted by a provider, supplier, or beneficiary represented by a provider or supplier that is submitted for the first time at the OMHA level, but the ultimate finding of whether there is good cause under these provisions would be at the discretion of the ALJ or attorney adjudicator. We believe that the proposed changes to § 405.1028 that we are adopting provide sufficient guidance regarding the circumstances in which an ALJ or attorney adjudicator may find good cause, and thus we do not believe it is necessary to include the commenter's requested revision in the notice of reconsideration. As explained above (and discussed in section III.A.2.j of the proposed rule), the proposed change to the notice of reconsideration at § 405.976(b)(5)(ii) was intended to reflect that evidence submitted after the reconsideration that does not meet the good cause standard will still be preserved in the administrative record, as the statement in § 405.976(b)(5)(ii) that the evidence would not be made part of the administrative record was inconsistent with current practice of making a complete record of the administrative proceedings for further review. In our ongoing effort to streamline the Medicare Appeals process, we encourage appellants to submit evidence as early on in the appeals process as possible, but do not believe the commenter's suggested revision is necessary to accomplish this goal.
After review and consideration of the comments received, for the reasons discussed above and in the proposed rule, we are finalizing without modification this change to § 405.976(b)(5)(ii) as proposed.
Section 405.978 discusses the effect of a QIC reconsideration, and states that a reconsideration is binding on all parties unless, among other things, an ALJ decision is issued in accordance with a request for an ALJ hearing made in accordance with § 405.1014. As discussed in section II.B of the proposed rule and II.A.2 of this final rule above, we proposed that an attorney adjudicator may issue a decision on a request for an ALJ hearing when a hearing is not conducted, and in section III.A.3.v of the proposed rule (as discussed in section II.B.3.v of this final rule below), we proposed to revise § 405.1048 to provide the effect of an attorney adjudicator's decision is equivalent to the effect of an ALJ's decision. To align with our proposals to provide that an attorney adjudicator may issue a decision on a request for an ALJ hearing when a hearing is not conducted and the effect of that decision is equivalent to the effect of an ALJ's decision, we proposed to insert “or attorney adjudicator” after the first use of “ALJ” in § 405.978(a) to indicate that a QIC reconsideration is binding on all parties unless, among other things, an ALJ or attorney adjudicator decision is issued in accordance to a request for an ALJ hearing made in accordance with § 405.1014. 81 FR 43790, 43800-43801.
We received no comments on this proposal, other than comments discussed in section II.A.2 above related to our general proposals to provide authority for attorney adjudicators to issue certain decisions, dismissals and remands, and to revise the rules so that decisions and dismissals issued by attorney adjudicators may be reopened and/or appealed in the same manner as equivalent decisions and dismissals issued by ALJs. Accordingly, for the reasons discussed above and in the proposed rule, we are finalizing this change to § 405.978 as proposed without modification.
As discussed below, we proposed a number of revisions to the rules governing reopening and revision of initial determinations and appeal decisions. 81 FR 43790, 43801. Sections 405.980 and 423.1980 set forth the rules governing reopening and revision of initial determinations, redeterminations, reconsiderations, decisions, and reviews; §§ 405.982 and 423.1982 set forth the rules governing notice of a revised determination or decision; and §§ 405.984 and 423.1984 set forth the rules on the effect of a revised determination or decision. Pursuant to §§ 405.1038 and 423.2038, an ALJ may issue a decision on a request for hearing without conducting a hearing in specified circumstances. As proposed in section II.B of the proposed rule (and discussed in section II.A.2 of this final rule above), an attorney adjudicator also would be able to issue decisions on requests for an ALJ hearing in specified circumstances, issue dismissals when a party withdraws a request for hearing, and issue decisions on requests to review QIC or IRE dismissals.
We proposed to insert “or attorney adjudicator” or “attorney adjudicator's,” after “ALJ” or “ALJ's” in
We also proposed to replace “hearing decision,” “hearing decisions,” or “hearings,” with “decision” or “decisions” in the titles of §§ 405.980 and 423.1980; §§ 405.980(a)(1)(iii), (d) introductory text, (d)(2), (e) introductory text, and (e)(2); 423.1980(a)(1)(iii), (d) introductory text, (d)(2), (e) introductory text, and (e)(2); to replace “hearing” with “ALJ or attorney adjudicator decision” in §§ 405.980(a)(1)(iv), (a)(4), (e)(2); 423.1980(a)(1)(iv), (a)(2), and (e)(2); and to replace “ALJ hearing decisions” and “hearing decision,” with “ALJ or attorney adjudicator decisions” and “ALJ or attorney adjudicator decision”, respectively, in §§ 405.984(d) and 423.1984(d). We stated in the proposed rule that these revisions would avoid any confusion that reopening under these provisions is limited to decisions for which an oral hearing was conducted, whether the decision is issued by an ALJ without conducting a hearing, as permitted under current rules or by an attorney adjudicator without conducting a hearing, as proposed in section II.B of the proposed rule (and discussed in section II.A.2 of this final rule above).
In addition, we proposed to add in §§ 405.980(a)(1)(iii), (d)(2), (e)(2), and 423.1980(a)(1)(iii), (d)(2), (e)(2) that an ALJ, or attorney adjudicator as proposed in section II.B of the proposed rule (and discussed in section II.A.2 of this final rule above), revises “his or her” decision and may reopen “his or her” decision, which reflects our current policy that the deciding ALJ may reopen his or her decision, and avoids any potential confusion that an ALJ or attorney adjudicator may reopen the decision of another ALJ or attorney adjudicator. We also proposed to insert “its” before “review” in §§ 405.980(a)(1)(iv) and 423.1980(a)(1)(iv) to indicate that the Council's review decision may only be reopened by the Council, to differentiate it from an ALJ or attorney adjudicator decision that the Council may also reopen. In addition, we proposed to specify in §§ 405.980(d)(2) and (e)(2), and 423.1980(d)(2) and (e)(2) that the Council may reopen “an ALJ or attorney adjudicator” decision consistent with the current policy that the Council may reopen an ALJ decision, and to differentiate the provisions from §§ 405.980(d)(3) and (e)(3), and 423.1980(d)(3) and (e)(3), which provide for the Council to reopen its review decision. We also proposed in § 405.980(e)(3) to insert “Council” before “review” to clarify that a party to a Council review may request that the Council reopen its decision.
Finally, we proposed at § 405.984(c) to replace “in accordance with § 405.1000 through § 405.1064” with “in accordance with § 405.1000 through § 405.1063” to account for the proposed removal of § 405.1064 discussed below.
We received no comments on these proposals, other than comments discussed in section II.A.2 above related to our general proposals to provide authority for attorney adjudicators to issue certain decisions, dismissals and remands, and to revise the rules so that decisions and dismissals issued by attorney adjudicators may be reopened and/or appealed in the same manner as equivalent decisions and dismissals issued by ALJs. Accordingly, for the reasons discussed above and in the proposed rule, we are finalizing our proposals as discussed above, without modification, to revise the rules governing the reopening and revision of initial determinations, redeterminations, reconsiderations, decisions, and reviews.
Sections 405.990 and 423.1990 set forth the procedures governing expedited access to judicial review (EAJR). Current §§ 405.990(d) and 423.1990(d) allow a requesting party to file an EAJR request with an ALJ or the Council, which is then responsible for forwarding the request to the EAJR review entity within 5 calendar days of receipt. In accordance with §§ 405.990(f) and 423.1990(e), a request for EAJR must be acted upon by the EAJR review entity within 60 calendar days after the date that the review entity receives a request and accompanying documents and materials. In practice, this process has resulted in confusion and delays for requesting parties when EAJR requests are sent directly to an ALJ or the Council. To simplify the process for requesting parties and to help ensure the timely processing of EAJR requests, we proposed to revise §§ 405.990(d)(1) and 423.1990(d)(1) to direct EAJR requests to the DAB, which administers the EAJR process. Specifically, we proposed at §§ 405.990(d)(1)(i) and (ii), and 423.1990(d)(1)(i) and (ii) that the requestor or enrollee may file a written EAJR request with the DAB with the request for ALJ hearing or Council review if a request for ALJ hearing or Council review is not pending, or file a written EAJR request with the DAB if an appeal is already pending for an ALJ hearing or otherwise before OMHA or the Council. We also proposed to revise §§ 405.990(i)(1) and (2) and 423.1990(h)(1) and (2) so that the review entity would forward a rejected EAJR request to OMHA or the Council instead of an ALJ hearing office or the Council, to align with the revised EAJR filing process in which a request for ALJ hearing is submitted to the DAB with an EAJR request; we stated that this would also help ensure OMHA can process the request for an ALJ hearing as quickly as possible in the event an EAJR request is rejected.
Sections 405.990(i)(2) and 423.1990(h)(2) provide that a 90 calendar day time frame will apply to an appeal when a rejected EAJR request is received by the hearing office or the Council. Section 405.990(b)(1)(ii) states that an EAJR request may be filed when a request for a QIC reconsideration has been escalated for an ALJ hearing, and in accordance with current § 405.1016(c), a 180 calendar day time frame will apply in that circumstance. In addition, §§ 405.1036(d) and 423.2036(d) allow an appellant or enrollee to waive the adjudication period for an ALJ to issue a decision specified in §§ 405.1016 and 405.2016, respectively, at any time during the hearing process. To address the possibility that a time frame other than
In addition, we proposed at § 405.990(i)(1) to remove the redundant “request” after “EAJR request” in current paragraph (i)(1), which was a drafting error; and at § 423.1990(b)(1)(i) to remove “final” before referring to a decision, dismissal, or remand order of the ALJ or attorney adjudicator, as proposed in section II.B of the proposed rule (and discussed in section II.A.2 above), because as we explained in the 2009 Final Rule (74 FR 65307 through 65308), final decisions of the Secretary are those for which judicial review may be immediately sought under section 205(g) of the Act and the use of “final” in current § 423.1990(b)(1)(i) may cause confusion with such a final decision.
We received no comments on these proposals, other than: (1) comments discussed in section II.A.2 above related to our general proposals to provide authority for attorney adjudicators to issue certain decisions, dismissals and remands, and to revise the rules so that decisions and dismissals issued by attorney adjudicators may be reopened and/or appealed in the same manner as equivalent decisions and dismissals issued by ALJs; and (2) comments discussed in section II.A.4 above related to our general proposal to reference OMHA or an OMHA office, in place of current references to an unspecified entity, ALJs, and ALJ hearing offices, when a reference to OMHA or an OMHA office provides a clearer explanation of a topic. Accordingly, for the reasons discussed above and in the proposed rule, we are finalizing these changes to § 405.990 and 423.1990 as proposed without modification.
As described below, we proposed a number of revisions to §§ 405.1000 and 423.2000, which provide a general overview and rules for hearings before an ALJ and decisions on requests for hearings. 81 FR 43790, 43802-43803. We proposed to revise §§ 405.1000(d), (e), (g); and 423.2000(d), (e), (g) to include decisions by attorney adjudicators, as proposed in section II.B of the proposed rule (and discussed in section II.A.2 above). We also proposed to retitle the sections to reflect that the provisions of the section extend to decisions by both ALJ and attorney adjudicators. We proposed to change the language in §§ 405.1000(a), (b), (c), and (d); and 423.2000(a) and (b) to state that a hearing may only be conducted by an ALJ. We stated in the proposed rule that these revisions would provide readers with an accurate overview of how a request for an ALJ hearing would be adjudicated, including the potential that a decision could be issued without conducting a hearing by an ALJ or an attorney adjudicator as proposed in section II.B of the proposed rule (and discussed in section II.A.2 above), while informing readers that if a hearing is conducted, an ALJ will conduct the hearing.
Section 405.1000(c) provides that CMS or a contractor may elect to participate in a hearing, and § 423.2000(c) provides that CMS, the IRE or Part D plan sponsor may request to participate in a hearing. As discussed in section III.A.3.f of the proposed rule and II.B.3.f of this final rule below, we proposed to revise §§ 405.1010 and 423.2010 so that these entities may elect (for § 405.1010) or request (for § 423.2010) to participate in the proceedings on a request for hearing, including participation before a hearing is scheduled. We proposed to revise §§ 405.1000(c) and 423.2000(c) so that the sections would reference §§ 405.1010 and 423.2010, respectively, with regard to participating in the proceedings. We stated in the proposed rule that by referencing §§ 405.1010 and 423.2010, the proposed revisions would direct readers to those sections addressing the full scope of potential participation by CMS or its contractors, or a Part D plan sponsor, on a request for an ALJ hearing, including participating in the proceedings on a request for an ALJ hearing, which as discussed in proposed §§ 405.1010 and 423.2010, may include any proceedings before an oral hearing is scheduled. We also proposed in § 405.1000(c) to state that CMS or its contractor may join the hearing before an ALJ as a party under § 405.1012, which would direct readers to the appropriate section addressing the full scope of CMS or its contractor acting as a party. (Because CMS, the IRE, and the Part D plan sponsor may not be a party to a hearing under part 423, subpart U, there is no corollary to § 405.1012 in that subpart and therefore a similar revision was not proposed for § 423.2000(c).)
Sections 405.1000(d) and 423.2000(d) provide that a decision is based on the hearing record, and §§ 405.1000(g) and 423.2000(g) reference a hearing record in describing when a decision can be issued based on the record, without a hearing. However, §§ 405.1042 and 423.2042 identify the record as the administrative record. We stated in the proposed rule that the references to a hearing record in paragraphs (d) and (g) may cause confusion when no hearing is conducted. To make the terminology consistent throughout the rules, account for decisions that are issued without a hearing being conducted, and minimize confusion, we proposed to revise §§ 405.1000(d) and 423.2000(d) so that a decision is based on the administrative record, including, for an ALJ, any hearing record, and §§ 405.1000(g) and 423.2000(g) to provide that a decision is based on the administrative record.
Section 405.1000(e) and (g) discuss two circumstances in which a decision on a request for hearing can be issued by an ALJ without conducting a hearing, either where the parties waive the hearing or where the record supports a fully favorable finding. Related to § 405.1000(e), § 405.1000(f) discusses the ALJ's authority to conduct a hearing even if the parties waive the hearing. As discussed in section III.A.3.r of the proposed rule and II.B.3.r of this final rule below, we proposed to revise § 405.1038 to modify the circumstances in which a decision on a request for hearing can be issued without conducting a hearing. As discussed in the proposed revisions to § 405.1038, we proposed in § 405.1038 that a case could be decided without a hearing before an ALJ if: (1) waivers are obtained by the parties entitled to a notice of hearing in accordance with § 405.1020(c) (§ 405.1038(b)(1)(i)); or (2) the record supports a fully favorable finding for the appellant on every issue and no other party to the appeal is liable for the claims at issue, unless CMS or a contractor has elected to be a party to the hearing (§ 405.1038(a)). We proposed to revise § 405.1000(e), (f), and (g) for consistency with the § 405.1038 proposals and to accurately summarize when a decision on a request for hearing can be issued without conducting a hearing in accordance with proposed § 405.1038. We did not propose similar changes in § 423.2000(e), (f), and (g) because we did not propose changes to when a decision on a request for hearing can be issued without conducting a hearing in § 423.2038.
Current § 405.964(c) requires a QIC to consolidate requests for a
Provided below are summaries of the specific comment received and response to the comment:
After review and consideration of the comments received, for the reasons discussed above and in the proposed rule, and in section II.B.3.r below concerning § 405.1038 (which also explains the circumstances in which a decision on a request for hearing can be issued without conducting a hearing), we are finalizing §§ 405.1000 and 423.2000 as proposed with the modifications discussed above.
As discussed below, we proposed a number of revisions to §§ 405.1002 and 423.2002, which discuss a right to an ALJ hearing. 81 FR 43790, 43803. Current §§ 405.1002(a) and 423.2002(a) provide that a party to a QIC reconsideration or the enrollee who receives an IRE reconsideration, respectively, may “request” a hearing before an ALJ if the party or enrollee files a timely request and meets the amount in controversy requirement. However, a party or enrollee is entitled to a hearing only when those requirements are met. See sections 1860D-4(h) and 1869(b)(1)(A) of the Act. Therefore, we proposed to revise §§ 405.1002(a) and 423.2002(a) introductory text to state that the party to a QIC reconsideration or the enrollee who receives an IRE reconsideration has a right to a hearing rather than may request a hearing. These revisions would align the provisions with the statute and clarify that the party or enrollee has a right to a hearing before an ALJ when the criteria are met.
Current §§ 405.1002(a)(4) and 423.2002(e) provide that the request is considered filed on the date it is received by the entity specified in the QIC's or IRE's reconsideration. There has been confusion when a request is sent to an OMHA office that is not specified in the reconsideration, and this error causes delays in processing the request. We proposed to revise §§ 405.1002(a)(4) and 423.2002(e) to replace “entity” with “office” to avoid confusion that the request may be filed with OMHA as an entity, and therefore any OMHA office, rather than the specific OMHA office identified in the QIC's or IRE's reconsideration. We stated in the proposed rule that this would help ensure appellants are aware that a request for hearing must be filed with the office indicated in the notice of reconsideration to avoid delays. For example, when the notice of reconsideration indicates that a request for hearing must be filed with the OMHA central docketing office, an appellant will cause a delay if the request is sent to the QIC or IRE, or an OMHA field office. We also noted in the proposed rule that as explained in the 2009 Final Rule (74 FR 65319 through 65320), pursuant to current § 405.1014(b)(2), if a request for hearing is timely filed with an entity other than the entity specified in the notice of reconsideration, the request is not treated as untimely or otherwise rejected. We stated that this would remain true for requests that are timely filed with an office other than the office specified in the notice of reconsideration, pursuant to proposed § 405.1014(c)(2), which incorporates the requirement from current § 405.1014(b)(2). This would also apply in part 423, subpart U adjudications because the same language appears in current § 423.2014(c)(2) and is incorporated in proposed § 423.2014(d)(2).
Current § 405.1002(b)(1) provides that when a party files a request with the QIC to escalate the appeal, it is escalated to “the ALJ level.” We proposed to revise § 405.1002(b)(1) to replace “to the ALJ level” with “for a hearing before an ALJ” so that when a request for a QIC
Current § 423.2002(c) provides that the ALJ must document all oral requests for expedited hearings. However, an ALJ is not assigned to an appeal until after the request for hearing is received and processed. Thus, we proposed to revise § 423.2002(c) to state that “OMHA” must document all oral requests for expedited hearings. There is no corresponding provision in part 405, subpart I.
Provided below are summaries of the specific comments received and responses to these comments:
We agree with the commenter that OMHA's policy of not treating as untimely a request for an ALJ hearing that is timely filed with an office other than the office specified in the QIC's or IRE's reconsideration should be expressly stated in the regulation. Thus, as discussed in section II.B.3.g.iv below, we are finalizing the additional language in proposed §§ 405.1014(c)(2) and 423.2014(d)(2)(i) to clarify that, if the request for hearing is timely filed with an office other than the office specified in the QIC's reconsideration, the request is not treated as untimely.
After review and consideration of the comments received, for the reasons discussed above and in the proposed rule, we are finalizing these changes to §§ 405.1002 and 423.2002 as proposed without modification. In addition, as discussed above and in section II.B.3.g.iv below, we are adding language in §§ 405.1014(c)(2) and 423.2014(d)(2)(i) to clarify that, if the request for hearing is timely filed with an office other than the office specified in the QIC's reconsideration, the request is not treated as untimely.
As discussed below, we proposed several revisions to §§ 405.1004 and 423.2004, which discuss the right to an ALJ review of a QIC notice of dismissal or IRE notice of dismissal, respectively. 81 FR 43790, 43803-43804. As proposed in section II.B of the proposed rule (and discussed in section II.A.2 above), attorney adjudicators or ALJs would conduct reviews of QIC or IRE dismissals. Accordingly, we proposed to remove references to an ALJ in the titles of proposed §§ 405.1004 and 423.2004, though ALJs would continue to have the authority to conduct reviews of QIC or IRE dismissals if a request for a review of a QIC or IRE dismissal is assigned to an ALJ. We also proposed to insert “or attorney adjudicator” after ALJ in §§ 405.1004(a) introductory language, (b), (c); and 423.2004(a) introductory language, (b), and (c), to provide that an attorney adjudicator could review a QIC or IRE dismissal, as proposed in section II.B of the proposed rule (and discussed in section II.A.2 above). We also proposed to replace the reference to “entity” in current §§ 405.1004(a)(4) and 423.2004(a)(4), with “office,” for the same reasons discussed in III.A.3.b of the proposed rule and II.B.3.b of this final rule above, for amending parallel language in §§ 405.1002 and 423.2002.
Current §§ 405.1004(b) and 423.2004(b) provide that if an ALJ determines that the QIC's or IRE's dismissal was in error, he or she vacates the dismissal and remands the case to a QIC or IRE. As discussed in III.A.3.p of the proposed rule and II.B.3.p of this final rule below, we proposed to revise the remand provisions and add new §§ 405.1056 and 405.1058, 423.2056, and 423.2058 to govern when remands may be issued, whether and to what extent remands may be reviewed, providing notice of a remand, and the effect of a remand. We also proposed to revise §§ 405.1004(b) and 423.2004(b) to add references to proposed §§ 405.1056 and 423.2056, respectively, to explain that the remand would be in accordance with proposed §§ 405.1056 and 423.2056, which as discussed in section III.A.3.p of the proposed rule and II.B.3.p of this final rule below, would address issuing remands and notices thereof, including for remands of QIC or IRE dismissals.
Current §§ 405.1004(c) and 423.2004(c) state that an ALJ's decision regarding a QIC's or IRE's dismissal of a reconsideration request is binding and not subject to further review, and that the dismissal of a request for ALJ review of a QIC's or IRE's dismissal of a reconsideration request is binding and not subject to further review, unless vacated by the Council under § 405.1108(h) or § 423.2108(b), respectively. In our experience, these sections as currently drafted have been a source of confusion for adjudicators and appellants. The two sentences convey different actions that can result from a request for review of a QIC or IRE dismissal—a decision regarding whether the QIC's or IRE's dismissal was correct, or a dismissal of the appellant's request for an ALJ review of the QIC's or IRE's dismissal. We proposed to separate and further distinguish the two situations to avoid the current confusion that results from two of the three possible outcomes that may result from a request to review a QIC or IRE dismissal (the third being a remand of the dismissal, addressed in paragraph (b) in the respective sections) being in the same paragraph by proposing a separate paragraph for each outcome currently addressed in paragraph (c).
We proposed to revise §§ 405.1004(c) and 423.2004(c) to include the possible outcome in the first sentence of current §§ 405.1004(c) and 423.2004(c) of a decision affirming the QIC's or IRE's dismissal. We also proposed to move language in current §§ 405.1004(c) and 423.2004(c) stating that the decision of an ALJ on a request for review of a QIC dismissal is binding and not subject to
The 2009 Final Rule (74 FR 65311 through 65312) also explained that if a request for ALJ review of a QIC dismissal was invalid and thus subject to dismissal, the dismissal of the request to review a QIC dismissal was binding and not subject to further review (however, a party could request that the dismissal be vacated by the Council pursuant to § 405.1108(b)). We proposed to add §§ 405.1004(d) and 423.2004(d) to state that the ALJ or attorney adjudicator may dismiss a request for review of a QIC's or an IRE's dismissal in accordance with proposed §§ 405.1052(b) or 423.2052(b), respectively, which as discussed in section III.A.3.x of the proposed rule and II.B.3.x of this final rule below, would address dismissals of requests for review of a QIC or IRE dismissal and notices thereof. We also proposed to move language in current §§ 405.1004(c) and 423.2004(c) stating that the dismissal is binding and not subject to further review unless the dismissal is vacated, to proposed §§ 405.1054(b) and 423.2054(b), which would address the effects of a dismissal of a request for review of a QIC's or an IRE's dismissal and as discussed in section III.A.3.x of the proposed rule and II.B.3.x of this final rule below, would provide authority for an ALJ or attorney adjudicator to vacate a dismissal and therefore replace the current reference to the Council.
We received no comments on these proposals, other than comments discussed in section II.A.2 above related to our general proposals to provide authority for attorney adjudicators to issue certain decisions, dismissals and remands, and to revise the rules so that decisions and dismissals issued by attorney adjudicators may be reopened and/or appealed in the same manner as equivalent decisions and dismissals issued by ALJs. Accordingly, for the reasons discussed above and in the proposed rule, we are finalizing these changes to §§ 405.1004 and 423.2004 as proposed without modification.
As described below, we proposed a number of changes to the amount in controversy provisions in §§ 405.1006, 423.1970, and 478.44, as well as an associated change to § 405.976(b)(7) regarding the content of a QIC's notice of reconsideration. 81 FR 43790, 43804-43810, 43854. Current § 405.1006 sets forth the requirements for meeting the amount in controversy for an ALJ hearing. The title of current § 405.1006 states that the amount in controversy is required to “request” an ALJ hearing and judicial review. However, as discussed in III.A.3.b of the proposed rule and II.B.3.b of this final rule above, section 1869(b)(1)(A) of the Act states that a party is entitled to a hearing before the Secretary and judicial review, subject to the amount in controversy and other requirements. To align the title of § 405.1006 with the statutory provision, we proposed that the amount in controversy is required “for” an ALJ hearing and judicial review rather than “to request” an ALJ hearing and judicial review. Put another way, a party may request an ALJ hearing or judicial review, albeit unsuccessfully, without satisfying the amount in controversy requirement.
Section 1869(b)(1)(E) of the Act establishes the minimum amounts in controversy for a hearing by the Secretary and for judicial review, but does not establish how to calculate the amounts in controversy. Current § 405.1006(d) states that the amount remaining in controversy is calculated based on the actual amount charged to the individual (a beneficiary) for the items or services in question (commonly referred to as billed charges), reduced by any Medicare payments already made or awarded for the items or services, and any deductible and coinsurance amounts applicable to the particular case. In an effort to align the amount in controversy with a better approximation of the amount at issue in an appeal, we proposed to revise the basis (that is, the starting point before any deductions for any payments already made by Medicare or any coinsurance or deductible that may be collected) used to calculate the amount in controversy. For appeals of claims submitted by providers of services, physicians, and other suppliers that are priced based on a published Medicare fee schedule or published contractor-priced amount (as discussed below), rather than using the actual amount charged to the individual as the basis for the amount in controversy, we proposed to use the Medicare allowable amount for the items and/or services being appealed, subject to the exceptions discussed below. An allowable amount is the maximum amount of the billed charge deemed payable for the item or service. For the purposes of the amount in controversy under § 405.1006, we proposed at § 405.1006(d)(2)(i)(A) that for items and services with a published Medicare fee schedule or published contractor-priced amount, the basis for the amount in controversy would be the allowable amount, which would be the amount reflected on the fee schedule or in the contractor-priced amount for those items or services in the applicable jurisdiction and place of service.
We stated in the proposed rule that for a vast majority of items and services furnished and billed by physicians and other suppliers, allowable amounts are determined based on Medicare fee schedules. Fee schedules generally are updated and published on an annual basis by CMS through rulemaking, and CMS and its contractors have tools and resources available to inform physicians and other suppliers of allowable amounts based on these fee schedules, including the Physician Fee Schedule Look-up Tool available at
We stated in the proposed rule that, due to the pricing methodology for many items and services furnished by providers of services, such as hospitals, hospices, home health agencies, and skilled nursing facilities, at the present time an allowable amount is not easily discerned or verified with existing CMS and contractor pricing tools (for example, there is no pricing tool available for hospital outpatient services paid under the outpatient prospective payment system (OPPS)) for pre-payment claim denials (where items or services on the claim are denied, in full or in part, before claim payment has been made). Similarly, we stated that items and services furnished by providers or suppliers that are always non-covered, as well as unlisted procedures, may not have published allowable amounts based on a fee schedule or a published contractor-priced amount. Therefore, we proposed at § 405.1006(d)(2)(i)(B) to continue using the provider's or supplier's billed charges as the basis for calculating the amount in controversy for appeals of claims that are not priced according to a CMS-published fee schedule and do not have a published contractor-priced amount (except as discussed below). We noted that the method for calculating the amount in controversy in this scenario would be the same as under current § 405.1006(d), and we stated that we believe that all appellants have access to this information through claims billing histories, remittance advices, or the column titled “Amount Provider [or Supplier] Charged” on the Medicare Summary Notice. However, we solicited comment on whether existing tools and resources are available that would enable providers, suppliers, and Medicaid State agencies to submit an allowable amount in their request for hearing, as proposed in section III.A.3.g.i of the proposed rule (and discussed in section II.B.3.g.i below) for items and services not subject to published fee schedules or published contractor-priced amounts, and whether those amounts could also be verified by OMHA. We also solicited comment on how such tools and resources could be used in appeals filed by beneficiaries.
Current § 405.1006(d)(1) introductory text uses “the actual amount charged the individual for the items and services in question” as the basis (starting point) for calculating the amount in controversy, before any reductions described in paragraphs (d)(1)(i) and (ii) (for any Medicare payments already made or awarded and any deductible and coinsurance applicable in the particular case) occur. For the reasons discussed above, we proposed to revise paragraph (d)(1) introductory text to state that in situations other than those described in § 405.1006(d)(3) through (7) (discussed below), the amount in controversy is computed as “the basis for the amount in controversy for the items and services in the disputed claim as defined in paragraph (d)(2)”, less applicable reductions described in paragraphs (d)(1)(i) and (ii), and proposed to revise paragraph (d)(2) to specify the amount that would be used as the basis for the amount in controversy on a situational basis. We also proposed at § 405.1006(d)(3) through (7) five exceptions to the general calculation methodology specified in proposed paragraphs (d)(1) and (2).
There has also been confusion in calculating the amount in controversy when an appealed reconsideration involves multiple claims. Section 1869 of the Act and part 405, subpart I provide for an appeals process in which each claim decision is appealed and separately adjudicated. However, in some instances, claims are considered together based on an appellant's request. To address confusion with calculating the amount in controversy when reconsiderations involve multiple claims and to help ensure § 405.1006 clearly conveys that the amount in controversy requirement must be met for each appealed claim unless the claim can be aggregated as discussed below, we proposed in § 405.1006(d)(1) to clarify that the amount in controversy is based on the items or services in the disputed “claim.”
We proposed to maintain the current reduction to the calculation of the amount in controversy in § 405.1006(d)(1)(i), which states that the basis for the amount in controversy is reduced by any Medicare payments already made or awarded for the items or services. In addition, current § 405.1006(d)(1)(ii) provides that the basis for the amount in controversy is further reduced by “[a]ny deductible and coinsurance amounts applicable in the particular case.” We proposed to revise § 405.1006(d)(1)(ii) to read, “Any deductible and/or coinsurance amounts that may be collected for the items or services.” We stated in the proposed rule that we believe revising this provision is appropriate to better align the amount at issue in the appeal and the amount in controversy so that in situations where a provider or supplier is prohibited from collecting applicable coinsurance and/or deductible, or must refund any such amounts already collected, the basis for the amount in controversy is not reduced by that amount (for example, if a provider or supplier is held liable for denied services under the limitation on liability provision in section 1879 of the Act, any amounts collected for the denied service, including coinsurance and/or deductible must be refunded).
As discussed above, we proposed at § 405.1006(d)(2)(i) that, for situations other than those described in § 405.1006(d)(2)(ii) and (iii), the basis for calculating the amount in controversy under § 405.1006(d)(1) would be the Medicare allowable amount, which is the amount reflected on the fee schedule or in the contractor-priced amount for those items or services in the applicable jurisdiction and place of service if there is a published Medicare fee schedule or published contractor-priced amount for the items or services in the disputed claim; or if there is no published Medicare fee schedule or contractor-priced amount for the items or services in the disputed claim, the basis for the amount in controversy would be the provider or supplier's billed charges submitted on the claim for the items and services. We stated that we believe providers, suppliers, and Medicaid State agencies would be able to utilize existing CMS and CMS contractor tools and resources to determine the allowable amount for items and services with published fee schedule or published contractor-priced amounts, and for items or services without a published fee schedule or published contractor-priced amount, the calculation methodology for the amount in controversy would be the same as the calculation methodology specified in current § 405.1006(d). However, we stated there may be instances where a beneficiary would appeal a claim for items and services for which the allowable amount would be the basis for the amount in controversy under proposed § 405.1006(d)(2)(i)(A) (for example, a claim for items or services with a published fee schedule or published contractor-priced amount that does not involve an overpayment and for which the beneficiary has not been determined to be financially responsible). We stated that we believe most beneficiaries are not familiar with published fee schedule or contractor-priced amounts and may be unable to determine the amount in controversy in
We also proposed at § 405.1006(d)(2)(iii) that if a beneficiary received or may be entitled to a refund of the amount the beneficiary previously paid to the provider or supplier for the items or services in the disputed claim under applicable statutory or regulatory authorities, the basis for the amount in controversy would be the actual amount originally charged to the beneficiary for the items or services in the disputed claim, as we stated in the proposed rule we believed that the amount originally charged to the beneficiary is more reflective of the actual amount at issue for the beneficiary and for the provider or supplier in this situation. We also stated we believed appellants would have access to and would use the same information for determining the basis for the amount in controversy under paragraph § 405.1006(d)(2)(iii) as they would under § 405.1006(d)(2)(ii).
As discussed above, we proposed at § 405.1006(d)(3) through (7) five exceptions to the general methodology used to calculate the amount in controversy specified in § 405.1006(d)(1). Current § 405.1006(d)(2) provides that, notwithstanding current § 405.1006(d)(1), when payment is made for items or services under section 1879 of the Act or § 411.400, or the liability of the beneficiary for those services is limited under § 411.402, the amount in controversy is computed as the amount that the beneficiary would have been charged for the items or services in question if those expenses were not paid under § 411.400 or if that liability was not limited under § 411.402, reduced by any deductible and coinsurance amounts applicable in the particular case. We proposed to re-designate current § 405.1006(d)(2) as § 405.1006(d)(3) and to revise the paragraph to state that when payment is made for items or services under section 1879 of the Act or § 411.400, or the liability of the beneficiary for those services is limited under § 411.402, the amount in controversy would be calculated in accordance with § 405.1006(d)(1) and (2)(i), except there is no deduction under paragraph (d)(1)(i) for expenses that are paid under § 411.400 or as a result of liability that is limited under § 411.402. For example, when a claim for items or services is denied under section 1862(a)(1)(A) of the Act because the items or services were not reasonable and necessary for the treatment of illness or injury or to improve the functioning of a malformed body member, Medicare payment may nonetheless be made under the limitation on liability provisions of section 1879 of the Act if neither the provider/supplier nor the beneficiary knew, or could reasonably have been expected to know, that payment would not be made. In instances such as these, we proposed that the amount in controversy would be calculated as if the items or services in the disputed claim were denied and no payment had been made under section 1879 of the Act. We stated in the proposed rule that we believed this exception was appropriate because appellants may still wish to appeal findings of non-coverage related to items and services for which liability of the party was limited or payment was made under section 1879 of the Act or § 411.400 or for which the beneficiary was indemnified under § 411.402, but if these payments or indemnifications were deducted from the basis for the amount in controversy, the amount in controversy could be zero. As this exception relates only to whether deductions are made under § 405.1006(d)(1)(i) for any Medicare payments already made or awarded for the items or services, and the amount in controversy would otherwise be calculated in accordance with proposed § 405.1006(d)(1) and (d)(2)(i), we stated we believed appellants would have access to and would use the same information for determining the amount in controversy under § 405.1006(d)(3) as they would under § 405.1006(d)(1) and (d)(2)(i).
Current § 405.1006 does not address calculating the amount in controversy for matters involving a provider or supplier termination of a Medicare-covered item or service when the beneficiary did not elect to continue receiving the item or service (for example, § 405.1206(g)(2) provides that if a beneficiary is dissatisfied with a QIO's determination on his or her discharge and is no longer an inpatient in a hospital, the determination is subject to the general claims appeal process). In this circumstance, items and services have not been furnished, and therefore, a claim has not been submitted. Yet the beneficiary may elect not to continue receiving items or services while appealing the provider or supplier termination due to potential financial responsibility for the items or services. While an amount in controversy cannot be assessed for a period of time during which no items or services were furnished, a beneficiary may assert a continuing need for the items or services based on his or her condition at the time an appeal is heard. To address this circumstance, we proposed new § 405.1006(d)(4), which would provide that when a matter involves a provider or supplier termination of Medicare-covered items or services and the beneficiary did not elect to continue receiving the items or services that are disputed by a
We considered using Medicare payable amounts for denied items and services as the basis for the amount in controversy calculation specified in proposed § 405.1006(d)(1), as we stated that would be a more precise estimate of the amount at issue in the appeal than either the Medicare allowable amount or the billed charges. Payable amounts would take into account payment rules related to the items and services furnished that may increase or decrease allowable amounts (for example, multiple surgery reductions, incentive payments, and competitive bidding payments). However, we stated that CMS systems do not currently calculate payable amounts for denied services, and undertaking major system changes would delay implementation and has been determined not to be cost effective. While payable amounts may be a better representation of the amount at issue in the appeal, we stated in the proposed rule that we believed the Medicare allowable amount and the other amount in controversy calculations provided in proposed § 405.1006(d) are appropriate and reliable estimates that align well with the amount at issue for claims for which a payable amount has not been calculated.
However, we stated that for post-payment denials, or overpayments, a payable amount has been determined and would be the most reliable indicator of the amount actually at issue in the appeal. Therefore, we proposed new § 405.1006(d)(5) to state that, notwithstanding the calculation methodology in proposed paragraphs (d)(1) and (2), when a claim appeal involves an overpayment determination, the amount in controversy would be the amount of the overpayment specified in the demand letter. In a post-payment denial, the amount of the overpayment identified in the demand letter is readily available to appellants, and is the most accurate reflection of the amount actually at issue in the appeal. In addition, current § 405.1006 does not address appeals that involve an estimated overpayment amount determined through the use of sampling and extrapolation. In this circumstance, the claims sampled to determine the estimated overpayment may not individually meet the amount in controversy requirement, but the estimated overpayment determined through the use of extrapolation may meet the amount in controversy requirement. To address this circumstance, we also proposed in new § 405.1006(d)(5) that when a matter involves an estimated overpayment amount determined through the use of sampling and extrapolation, the estimated overpayment as extrapolated to the entire statistical sampling universe is the amount in controversy. We stated that this proposal would provide appellants the opportunity to appeal claims that may not individually meet the amount in controversy requirement if such claims were part of the sample used in making an overpayment determination that does meet the amount in controversy requirement. Because the overpayment determination reflects the amount for which the appellant is financially responsible, we stated in the proposed rule that we believed it would be appropriate to allow appellants to appeal individual claims in the sample that was used to determine the overpayment. Whether an appeal involves an individual overpayment or an estimated overpayment determined through the use of sampling and extrapolation, we stated in the proposed rule that we believed appellants against whom an overpayment was assessed would need only to consult the demand letter they received in order to determine the amount in controversy. However, we also stated that we expected there may be circumstances where a beneficiary wishes to appeal an overpayment that was assessed against a provider or supplier, and in these situations the beneficiary may not have a copy of the demand letter that was received by the provider or supplier. For this reason, and as discussed below, we proposed at § 405.976(b)(7) that the QIC would include in its notice of reconsideration a statement of whether the amount in controversy is estimated to meet or not meet the amount required for an ALJ hearing, if the request for reconsideration was filed by a beneficiary who is not represented by a provider, supplier, or Medicaid State agency, and the reconsideration decision was partially or fully unfavorable.
We also proposed new § 405.1006(d)(6), which would provide that when a beneficiary files an appeal challenging only the computation of a coinsurance amount, or the amount of a remaining deductible applicable to the items or services in the disputed claim, the amount in controversy is the difference between the amount of the coinsurance or remaining deductible, as
In addition, we proposed new § 405.1006(d)(7) to provide that for appeals of claims where the allowable amount has been paid in full and the appellant is challenging only the validity of the allowable amount, as reflected in the published Medicare fee schedule or in the published contractor-priced amount applicable to the items or services in the disputed claim, the amount in controversy is the difference between the amount the appellant argues should have been the allowable amount for the items or services in the disputed claim in the applicable jurisdiction and place of service, and the published allowable amount for the items or services. We stated in the proposed rule that we believed this provision is appropriate in these instances because, without this provision, the amount in controversy determined under the general calculation methodology in § 405.1006(d)(1) would be zero for such paid claims. In addition, we stated we believed that the calculation proposed at § 405.1006(d)(7) would appropriately reflect the amount at issue for the appellant in these appeals. We also stated that we believed that, generally, these types of appeals are filed by providers and suppliers who are already familiar with the allowable amount for the items or services in the disputed claim based on information obtained from published fee schedules or contractor-priced amounts. Further, we stated that we believed that a fee schedule or contractor price challenge filed by a beneficiary on a paid claim would be a very rare occurrence. However, as discussed below, in the event a beneficiary would want to file such an appeal, the beneficiary could obtain an estimate of the amount in controversy from the QIC reconsideration. As discussed further below, we proposed at § 405.976(b)(7) that the QIC would include in its notice of reconsideration a statement of whether the amount in controversy is estimated to meet or not meet the amount required for an ALJ hearing, if the request for reconsideration was filed by a beneficiary who is not represented by a provider, supplier, or Medicaid State agency, and the reconsideration decision was partially or fully unfavorable.
In the event that a reconsideration, or a redetermination if the appeal was escalated from the QIC without a reconsideration, involves multiple claims and some or all do not meet the amount in controversy requirement, section 1869 of the Act states that, in determining the amount in controversy, the Secretary, under regulations, shall allow two or more appeals to be aggregated if the appeals involve the delivery of similar or related services to the same individual by one or more providers or suppliers, or common issues of law and fact arising from services furnished to two or more individuals by one or more providers or suppliers. Under this authority, § 405.1006(e) provides for aggregating claims to meet the amount in controversy requirement.
The title of current § 405.1006(e)(1) for aggregating claims when appealing a QIC reconsideration is phrased differently than the corresponding title for aggregating claims when escalating a request for a QIC reconsideration in current § 405.1006(e)(2), which may cause confusion. We proposed to revise the title to § 405.1006(e)(1) to “Aggregating claims in appeals of QIC reconsiderations for an ALJ hearing” so it clearly applies to aggregating claims in appeals of QIC reconsiderations, and is parallel to the phrasing used in the title of § 405.1006(e)(2). The proposed titles of § 405.1006(e)(1) and (e)(2), and proposed § 405.1006(e)(2)(ii) would also replace “to the ALJ level” with “for an ALJ hearing” to again highlight that the appeal of a QIC reconsideration or escalation of a request for a QIC reconsideration is for an ALJ hearing.
Current § 405.1006(e)(1)(ii) provides that to aggregate claims, the request for ALJ hearing must list all of the claims to be aggregated. We stated in the proposed rule that this has caused confusion because some appellants read current § 405.1006(e)(1)(ii) as allowing appeals of new claims to be aggregated with claims in previously filed appeals, provided the new request for hearing lists the claims involved in the previously filed appeals. However, current § 405.1006(e)(2)(i), which applies to aggregating claims that are escalated from the QIC for a hearing before an ALJ, requires that the claims were pending before the QIC in conjunction with the same request for reconsideration. We noted in the proposed rule that in the context of a request for hearing, aggregating new claims with claims from previously filed requests could delay the adjudication of the requests and is inconsistent with the current rule for aggregating claims that are escalated from the QIC. To address these issues and bring consistency to the aggregation provisions, we proposed to revise § 405.1006(e)(1)(ii) to require the appellant(s) to request aggregation of the claims in the same request for ALJ hearing or in multiple requests for an ALJ hearing filed with the same request for aggregation. We stated that this would allow an individual or multiple appellants to file either one request for an ALJ hearing for multiple claims to be aggregated, or multiple requests for an ALJ hearing for the appealed claims when requesting aggregation, while requiring them to be filed together with the associated request for aggregation. We also proposed in § 405.1006(e)(1)(iii) and (e)(2)(iii) that an ALJ or attorney adjudicator may determine that the claims that a single appellant seeks to aggregate involve the delivery of similar or related services, or the claims that multiple appellants seek to aggregate involve common issues of law and fact, but only an ALJ may determine the claims that a single appellant seeks to aggregate do not involve the delivery of similar or related services, or the claims that multiple appellants seek to aggregate do not involve common issues of law and fact. We proposed this because an attorney adjudicator adjudicating requests for an ALJ hearing when no hearing is conducted, as proposed in section II.B of the proposed rule (and discussed in section II.A.2 above), would not be permitted under this proposed rule to dismiss a request for an ALJ hearing due to procedural issues such as an invalid aggregation
Current § 405.976(b)(7) requires that the QIC notice of reconsideration contain a statement of whether the amount in controversy needed for an ALJ hearing is met when the reconsideration is partially or fully unfavorable. We proposed to revise § 405.976(b)(7) to require that the QIC notice of reconsideration include a statement of whether the amount in controversy is estimated to meet or not meet the amount required for an ALJ hearing only if the request for reconsideration was filed by a beneficiary who is not represented by a provider, supplier, or Medicaid State agency, and the reconsideration is partially or fully unfavorable. In line with current practice, we did not propose to require that the QIC indicate what it believes to be the exact amount in controversy, but rather only an estimate of whether it believes the amount in controversy is met, because, as we stated in the proposed rule, we believe the ultimate responsibility for determining whether the amount in controversy required for an ALJ hearing is met lies with appellants, subject to verification by an ALJ or attorney adjudicator (though, as discussed in section II.B of the proposed rule and II.A.2 of this final rule above, only an ALJ would be able to dismiss a request for hearing for failure to meet the amount in controversy required for an ALJ hearing). We stated in the proposed rule that we believe that providers, suppliers, and Medicaid State agencies have the tools, resources, and payment information necessary to calculate the amount in controversy in accordance with § 405.1006(d), and are familiar with the allowable amounts for the places of service in which they operate. Furthermore, applicable plans against whom a Medicare Secondary Payer overpayment is assessed would have access to the overpayment amount specified in the demand letter, which would be used to determine the amount in controversy under proposed § 405.1006(d)(5). Thus, we stated that we did not believe it was necessary for the QICs to continue to provide this statement for providers, suppliers, applicable plans, Medicaid State agencies, or beneficiaries represented by providers, suppliers or Medicaid State agencies. Furthermore, as discussed in section III.A.3.g.i of the proposed rule and II.B.3.g.i of this final rule below, we proposed that appellants, other than beneficiaries who are not represented by a provider, supplier, or Medicaid State agency, include the amount in controversy in their requests for hearing (unless the matter involves a provider or supplier termination of Medicare-covered items or services that is disputed by a beneficiary, and the beneficiary did not elect to continue receiving the items or services). As providers, suppliers, Medicaid State agencies, applicable plans, and beneficiaries represented by a provider, supplier, or Medicaid State agency would be responsible for calculating the amount in controversy and including it on the request for hearing as proposed in section III.A.3.g.i of the proposed rule (and discussed in section II.B.3.g.i below), we stated that we did not believe a statement by the QIC that indicates only whether the amount in controversy was or was not met adds significant value to such appellants. Furthermore, we expected that the Medicare allowable amount under proposed § 405.1006(d)(2)(i)(A) would be the basis for the amount in controversy in the majority of Part B appeals filed by non-beneficiary appellants. While QICs have access to the amount charged to an individual based on billed charges, the allowable amounts for claims vary based on where these items and services were furnished, and the applicable fee schedules and contractor-priced amounts, and continuing to require the QICs to include a statement whether the amount in controversy needed for an ALJ hearing is met in all instances in which the decision is partially or fully unfavorable to the appellant would require substantially more work by the QIC, and could delay reconsiderations and increase costs to the government.
Although we did not propose that beneficiaries who are not represented by a provider, supplier, or Medicaid State agency would need to include the amount in controversy on their requests for hearing (as discussed later in this preamble), we stated in the proposed rule that we believed there may be instances where a beneficiary would want to know if the amount in controversy meets the amount required for an ALJ hearing when deciding whether to file a request for hearing. We also stated we believed there may be instances where a beneficiary who is not represented by a provider, supplier, or Medicaid State agency may not currently have sufficient information to determine whether the amount in controversy required for an ALJ hearing is met under proposed § 405.1006. For example, under proposed § 405.1006(d)(2)(i)(A), for items and services with a published Medicare fee schedule or published contractor-priced amount (and for which the beneficiary was determined to be not financially responsible), the basis for the amount in controversy would generally be the allowable amount, which is the amount reflected on the fee schedule or in the contractor-priced amount for those items or services in the applicable jurisdiction and place of service. Beneficiaries not represented by a provider, supplier, or Medicaid State agency would not generally be expected to be familiar with fee schedule and contractor-priced amounts, and we stated we believed they may have difficulty determining whether the amount in controversy required for an ALJ hearing is met in these cases. We also stated we believed beneficiaries not represented by a provider, supplier, or Medicaid State agency might be unable to determine the amount of an overpayment assessed against a provider or supplier for items or services furnished to the beneficiary for purposes of calculating the amount in controversy under proposed § 405.1006(d)(5), as the beneficiary might not have access to the demand letter received by the provider or supplier, and may no longer have access to the Medicare Summary Notice reflecting the original payment amount. Accordingly, because there are situations where such beneficiaries may not have sufficient information to determine the amount in controversy, we proposed to revise § 405.976(b)(7) to state that the QIC would include in its notice of reconsideration a statement of whether the amount in controversy is estimated to meet or not meet the amount required for an ALJ hearing, if the request for reconsideration was filed by a beneficiary who is not represented by a provider, supplier, or Medicaid State agency, and the reconsideration decision was partially or fully unfavorable.
Current § 423.1970 describes the amount in controversy requirement for part 423, subpart U proceedings. For the same reasons we proposed to revise § 405.1006(e)(1)(ii), we proposed in § 423.1970(c)(1)(ii) and (c)(2)(ii) to provide that a single enrollee's or multiple enrollees' request for
Current § 422.600(b) provides that the amount in controversy for appeals of reconsidered determinations to an ALJ (under the Part C MA program), is computed in accordance with part 405. However, if the basis for the appeal is the MAO's refusal to provide services, current § 422.600(c) provides that the projected value of those services are used to compute the amount in controversy. We did not propose to revise these provisions because, as we stated in the proposed rule, we believed the proposed revisions to § 405.1006 described above encompass and have application to the scenarios appealed under part 422, subpart M. In particular, we noted that as is the case under current § 405.1006, if an enrollee received items or services and is financially responsible for payment because the MAO has refused to cover the item or services, the amount in controversy would be calculated using the billed charges as the basis for the amount in controversy, as provided in proposed § 405.1006(d)(2)(ii). We stated that if the enrollee did not receive the items or services, the provisions of current § 422.600(c) would apply. We also noted that current §§ 422.622(g)(2) and 422.626(g)(3) provide for an appeal to an ALJ, the Council, or federal court of an IRE's affirmation of a termination of provider services “as provided for under [part 422, subpart M],” thus triggering the amount in controversy rules in 422.600, which cross-reference part 405 (that is, the rules proposed here). We stated that proposed § 405.1006 would address scenarios appealed under part 422, subpart M that are not clearly addressed in current § 405.1006, such as provider service terminations, which would be addressed in proposed § 405.1006(d)(4), and coinsurance and deductible challenges, which would be addressed in proposed § 405.1006(d)(6).
Current § 478.44(a) also references back to part 405 provisions for determining the amount in controversy when requesting an ALJ hearing after a QIO reconsidered determination. We proposed revisions to § 478.44 in section III.D.3 of the proposed rule (as discussed in section II.E.3 below), to update part 405 references, but we did not propose in § 478.44 to revise how the current or proposed part 405 provision would be applied in calculating the amount in controversy. Similar to the part 422, subpart M provisions discussed above, we stated that we believe the proposed revisions to § 405.1006 described above encompass and have application to the scenarios appealed under part 478, subpart B.
We received 14 comments on these proposals. Provided below are summaries of the specific comments received and responses to these comments:
After considering the comments received and further analysis of our proposal to revise the calculation of the amount in controversy to use the Medicare allowable amount as set forth in proposed § 405.1006(d)(2)(i)(A), we
Based on further analysis spawned by the public comments, we believe the costs of the proposal are likely higher than originally anticipated. These costs include costs to the appellant community in identifying the published Medicare fee schedule or published contractor-priced amount to include in the request for hearing; and the administrative costs to the government of calculating the amount for certain appellants, and verifying and resolving conflicts over the calculation. While our estimation of 2,600 fewer appeals for low-value claims that we believe would enter the appeals process if the proposal were finalized does provide a clear benefit, we estimate the costs to the Federal government would be roughly twice the projected benefit and recognize the appellant community would incur additional costs as well. Therefore, we do not believe this estimated benefit outweighs the potential costs at this time based on our revised analysis.
Thus, at this time we are not finalizing our proposal under § 405.1006(d)(2)(i)(A) to use the Medicare allowable amount as the basis for the amount in controversy for items and services that are priced based on a published Medicare fee schedule or published contractor-priced amount. In addition, we are not finalizing proposed § 405.1006(d)(2)(i)(B), because, given that we are not finalizing proposed § 405.1006(d)(2)(i)(A), there is no longer a need to distinguish between items and services with and without a published Medicare fee schedule or contractor-priced amount. Instead, we will continue to use the methodology specified in § 405.1006(d)(1) as the general methodology for calculating the amount in controversy, except that we are finalizing our proposal to replace “for the items and services in question” with “for the items and services in the disputed claim” in § 405.1006(d)(1) introductory text because the amount in controversy is calculated on a claim-by-claim basis, and there has been confusion when a single reconsideration decision involves multiple claims. We are also replacing “applicable in the particular case” with “that may be collected for the items or services” in § 405.1006(d)(1)(ii) because, as explained above and in section III.A.3.d of the proposed rule, there may be situations where a provider or supplier is prohibited from collecting applicable coinsurance and/or deducible amounts, or must refund any such amounts already collected, and in these situations the amount in controversy should not be reduced by that amount. Furthermore, because we will continue to use § 405.1006(d)(1), as revised above, we are not finalizing proposed § 405.1006(d)(1).
In addition, we also are not finalizing proposed § 405.1006(d)(2)(ii) and (iii) because there is no need to define the basis for the amount in controversy in specific situations, as the amount in controversy would be calculated on the basis of the amount charged the individual in all of the scenarios described in proposed § 405.1006(d)(2)(i) through (iii). However, for the reasons discussed above and in section III.A.3.d of the proposed rule, we continue to believe that it would be appropriate to finalize separate calculations of the amount in controversy to address the situations in proposed § 405.1006(d)(3) through (7). Therefore, we are finalizing, with the modifications discussed below, the exceptions to the general calculation methodology that we proposed at § 405.1006(d)(3) through (7), which are being renumbered as § 405.1006(d)(2) through (6) in this final rule.
However, as we explained above and in the proposed rule, the statute does not specify how to calculate the amount in controversy. Section 405.1006(d)(1) provides that, subject to the exception in paragraph (d)(2), the amount in controversy is computed as the actual amount charged the individual for the items and services in question, reduced by any Medicare payments already made or awarded for the items or services and any deductible or coinsurance amounts applicable in the particular case. Because the actual amount charged the individual may not
With regard to the commenter's concern that under our proposal at § 405.1006(d)(2)(i)(A), MAOs would need to provide their contracted rates for appeals that involve supplemental plan benefits, and the commenter's request for clarification regarding how this proposal would affect pre-service requests for coverage, we note that, for the reasons explained above, we are not finalizing our proposal in § 405.1006(d)(2)(i)(A) to use the Medicare allowable amount as the basis for the amount in controversy for items and services that are priced based on a published Medicare fee schedule or published contractor-priced amount, nor are we finalizing proposed § 405.1006(d)(2)(ii) or (d)(2)(iii).
After review and consideration of the comments received, for the reasons discussed above, we are finalizing proposed § 405.1006 with the following modifications. We are not finalizing our proposal at § 405.1006(d)(2)(i)(A) to use the Medicare allowable amount to calculate the amount in controversy for items and services that are priced based on a published Medicare fee schedule or published contractor-priced amount. In addition, we are not finalizing § 405.1006(d)(2)(i)(B), because, given that we are not finalizing § 405.1006(d)(2)(i)(A), there is no longer a need to distinguish between items and services with and without a published Medicare fee schedule or contractor-priced amount. We also are not finalizing proposed § 405.1006(d)(2) or (d)(2)(i) introductory text, as there is no need for this language given that we are not finalizing § 405.1006(d)(2)(i)(A) or (B). Accordingly, we are maintaining the text of current § 405.1006(d)(1), except that we are: (1) Adding “In general” as a paragraph heading as proposed; (2) replacing “for the items and services in question” with “for the items and services in the disputed claim” in § 405.1006(d)(1) introductory text as proposed; and (3) replacing “Any deductible and coinsurance amounts applicable in the particular case” in current § 405.1006(d)(1)(ii) with “Any deductible and/or coinsurance amounts that may be collected for the items or services” as proposed. Furthermore, as discussed above, because we will continue to use current § 405.1006(d)(1) as revised above to calculate the amount in controversy, we are not finalizing proposed § 405.1006(d)(1) introductory text.
In addition, we also are not finalizing proposed § 405.1006(d)(2)(ii) and (iii) because there is no need to define the basis for the amount in controversy in specific situations, as the amount in controversy would be calculated on the basis of the amount charged the individual in all of the scenarios described in proposed § 405.1006(d)(2)(i) through (iii). Furthermore, we are not finalizing our proposal to revise and re-designate current § 405.1006(d)(2) as § 405.1006(d)(3), except for the proposal to add “Limitation on liability” as a paragraph heading. However, for consistency with paragraph (d)(1)(ii) as finalized, we are replacing “any deductible and coinsurance amounts applicable in the particular case” in current § 405.1006(d)(2) with “any deductible and/or coinsurance amounts that may be collected for the items or services.”
We are finalizing proposed § 405.1006(d)(4), (5), (6), and (7) with the modifications discussed below, but re-designating them as paragraphs (d)(3), (4), (5), and (6), respectively, because we are not finalizing proposed § 405.1006(d)(2) or re-designating current § 405.1006(d)(2) as § 405.1006(d)(3). We are replacing “in accordance with paragraphs (d)(1) and (d)(2)(ii) of this section, except that the basis for the amount in controversy” in paragraph (d)(3) as finalized (proposed paragraph (d)(4)) with “in accordance with paragraph (d)(1) of this section, except that the amount charged to the individual.” In addition, we are replacing “Notwithstanding paragraphs (d)(1) and (2) of this section” in paragraphs (d)(4), (5), and (6) as finalized (proposed paragraphs (d)(5), (6), and (7)) with “Notwithstanding paragraph (d)(1) of this section.”
Finally, we are finalizing our proposal to revise § 405.976(b)(7), the section heading of § 405.1006, and the changes to § 405.1006(e)(1) introductory text, (e)(1)(ii) and (iii), (e)(2) introductory text, (e)(2)(ii) and (iii), and § 423.1970(c)(1)(ii) and (iii), (c)(2)(ii) and (iii) as proposed, without modification.
Current §§ 405.1008 and 423.2008 discuss the parties to an ALJ hearing. Because current §§ 405.1002(a) and 423.2002(a) already address who may request a hearing before an ALJ after a QIC or IRE issues a reconsideration and current § 405.1002(b) addresses who may request escalation of a request for a QIC reconsideration, we proposed to remove current §§ 405.1008(a) and 423.2008(a). 81 FR 43790, 43810.
We proposed to retain and revise the language as discussed below in current §§ 405.1008(b) and 423.2008(b), but remove the paragraph designation. Current §§ 405.1008(b) and 423.2008(b) identify the parties “to the ALJ hearing,” but this could be read to be limited to parties to an oral hearing, if a hearing is conducted. To address this potential confusion, we proposed to revise §§ 405.1008 and 423.2008 to replace “parties to an ALJ hearing” with “parties to the proceedings on a request for an ALJ hearing” and “party to the ALJ hearing” with “party to the proceedings on a request for an ALJ hearing.” Likewise, we also proposed to revise the titles to §§ 405.1008 and 423.2008 from “Parties to an ALJ hearing” to “Parties to the proceedings on a request for an ALJ hearing.” 81 FR 43790, 43810.
Provided below are summaries of the specific comments received and responses to these comments:
After review and consideration of the comments received, for the reasons discussed above and in the proposed rule, we are finalizing these changes to §§ 405.1008 and 423.2008 as proposed without modification.
As further described below, we proposed significant revisions to §§ 405.1010 and 405.1012 regarding CMS and CMS contractors as participants or parties in proceedings on a request for an ALJ hearing, and to § 423.2010 regarding CMS, the IRE, or a Part D plan sponsor as participants in proceedings on a request for an ALJ hearing. 81 FR 43790, 43810-43816, 43862-43863, and 43879-43880.
Current § 405.1010(a) provides that an ALJ may request, but may not require, CMS and/or its contractors to participate in any proceedings before the ALJ, including the oral hearing, if any, and CMS or its contractors may elect to participate in the hearing process. Under current § 405.1010(b), if that election is made, CMS or its contractor must advise the ALJ, the appellant, and all other parties identified in the notice of hearing of its intent to participate no later than 10 calendar days after receiving the notice of hearing. Section 405.1010(c) sets forth what participation includes and § 405.1010(d) states that participation does not include CMS or its contractor being called as a witness during the hearing. Section 405.1010(e) requires CMS or its contractors to submit any position papers within the time frame designated by the ALJ. Finally, § 405.1010(f) states that the ALJ cannot draw any adverse inferences if CMS or a contractor decides not to participate in any proceedings before an ALJ, including the hearing.
We stated in the proposed rule that the reference to the period in which an election to participate must be filed beginning upon receipt of the notice of hearing in current § 405.1010(b) has caused confusion when CMS or its contractors attempt to enter proceedings before a hearing is scheduled, or when no notice of hearing is necessary because an appeal may be decided on the record. To help ensure that CMS and its contractors have the opportunity to enter the proceedings with minimal disruption to the adjudication process prior to a hearing being scheduled or when a hearing may not be conducted, we proposed in § 405.1010(a)(1) to provide that CMS or its contractors may elect to participate in the proceedings on a request for an ALJ hearing upon filing a notice of intent to participate in accordance with paragraph (b), at either of, but not later than, two distinct points in the adjudication process described in paragraph (b)(3).
As provided in current § 405.1010(a) and (f), we proposed at § 405.1010(a)(2) that an ALJ may request but may not require CMS and/or one or more of its contractors to participate in any proceedings before the ALJ, including the oral hearing, if any; and the ALJ cannot draw any adverse inferences if CMS or the contractor decides not to participate in the proceedings.
We proposed in § 405.1010(b) to address how CMS or a contractor makes an election to participate in an appeal, before or after receipt of a notice of hearing or when a notice of hearing is not required. Under § 405.1010(b)(1), we proposed that if CMS or a contractor elects to participate before receipt of a notice of hearing (such as during the 30 calendar day period after being notified that a request for hearing was filed as proposed in § 405.1010(b)(3)(i)) or when a notice of hearing is not required, CMS or the contractor must send written notice of its intent to participate to the parties who were sent a copy of the notice of reconsideration, and to the assigned ALJ or attorney adjudicator, as proposed in section II.B of the proposed rule (and discussed in section II.A.2 above), or if the appeal is not yet assigned, to a designee of the Chief ALJ. We proposed at § 405.1010(b)(1) to provide for sending the written notice of intent to participate to an ALJ or attorney adjudicator assigned to an appeal because, as we discussed in section II.B of the proposed rule and II.A.2 of this final rule above, an attorney adjudicator also would have the authority to issue decisions on a request for an ALJ hearing when no hearing is conducted, and in accordance with proposed § 405.1010, CMS or its contractors are permitted to participate in the proceedings on such a request. We also proposed at § 405.1010(b)(1) to provide for sending the notice of intent to participate to a designee of the Chief ALJ if a request for an ALJ hearing is not yet assigned to an ALJ or attorney adjudicator because CMS or a contractor could file an election to be a participant in the proceedings before the assignment process is complete. We stated in the proposed rule that proposed § 405.1010(b)(1) would help ensure that the potential parties to a hearing, if a hearing is conducted, would receive notice of the intent to participate, and also help ensure that adjudicators who are assigned to an appeal after an election is made would be aware of the election. Because only an ALJ may conduct a hearing and the parties to whom a notice of hearing is sent may differ from the parties who were sent a copy on the notice of reconsideration, we proposed at § 405.1010(b)(2) that if CMS or a contractor elects to participate after receiving a notice of hearing, CMS or the contractor would send written notice of its intent to participate to the ALJ and the parties who were sent a copy of the notice of hearing.
We proposed at § 405.1010(b)(3)(i) that CMS or a contractor would have an initial opportunity to elect to be a participant in an appeal within 30 calendar days after notification that a request for hearing has been filed with OMHA, if no hearing is scheduled. CMS and its contractors have the capability to see that a QIC reconsideration had been appealed to OMHA in the case management system used by QICs. This system would provide constructive notice to the QICs when the system indicates an appeal has been filed with OMHA, which OMHA can monitor through the date that the reconsideration data is transferred to OMHA to adjudicate the request for an ALJ hearing. Under proposed § 405.1010(b)(3)(ii), a second opportunity to elect to be a participant in an appeal would become available if a hearing is scheduled; as in the current rule, CMS or a contractor would have 10 calendar days after receiving the notice of hearing to make the election.
As we stated in the proposed rule, we considered allowing CMS or a contractor to make an election at any time prior to a decision being issued if a hearing was not scheduled, or sending a notice that a decision would be issued without a hearing and establishing an election period after such notice. However, both of these options would disrupt and delay the adjudication process, as well as add administrative burdens on OMHA. We stated in the proposed rule that we believed the 30 calendar day period after notification that a request for hearing was filed is sufficient time for CMS or a contractor to determine whether to elect to be a participant in the appeal while the record is reviewed for case development and to prepare for the hearing, or determine whether a decision may be appropriate based on the record in accordance with § 405.1038.
We proposed to consolidate current § 405.1010(c) through (e) in proposed
We proposed to incorporate current § 405.1010(e) in proposed § 405.1010(c)(3) with certain revisions as discussed below. Current § 405.1010(e) states that CMS or its contractor must submit any position papers within the time frame designated by the ALJ. We proposed in § 405.1010(c)(3) to include written testimony in the provision, establish deadlines for submission of position papers and written testimony that reflect the changes in participation elections in proposed § 405.1010(b), and require that copies of position papers and written testimony be sent to the parties. Specifically, we proposed in § 405.1010(c)(3)(i) that CMS or a contractor position paper or written testimony must be submitted within 14 calendar days of an election to participate if no hearing has been scheduled, or no later than 5 calendar days prior to the scheduled hearing unless additional time is granted by the ALJ. We proposed to add “written testimony” to recognize that CMS or a contractor may submit written testimony as a participant, in addition to providing oral testimony at a hearing. We proposed to require position papers and written testimony be submitted within 14 calendar days after an election if no hearing is scheduled to help ensure the position paper and/or written testimony are available when determinations are made to schedule a hearing or issue a decision based on the record in accordance with § 405.1038. We also proposed to require that if a hearing is scheduled, position papers and written testimony be submitted no later than 5 calendar days prior to the hearing (unless the ALJ grants additional time) to help ensure the ALJ and the parties have an opportunity to review the materials prior to the hearing. Additionally, under proposed § 405.1010(c)(3)(ii), CMS or a contractor would need to send a copy of any position paper or written testimony submitted to OMHA to the parties who were sent a copy of the notice of reconsideration if the position paper or written testimony is submitted to OMHA before receipt of a notice of hearing, or to the parties who were sent a copy of the notice of hearing if the position paper or written testimony is submitted after receipt of a notice of hearing. Current § 405.1010 does not address the repercussions of a position paper not being submitted in accordance with the section. Therefore, we proposed in § 405.1010(c)(3)(iii) that a position paper or written testimony would not be considered in deciding an appeal if CMS or a contractor fails to send a copy of its position paper or written testimony to the parties, or fails to submit its position paper or written testimony within the established time frames. We stated in the proposed rule that this would help ensure CMS or contractor position papers and written testimony are submitted timely and shared with the parties.
Current §§ 405.1010 does not limit the number of entities that may elect to be participants, which currently includes participating in a hearing if a hearing is conducted, and current § 405.1012 does not limit the number of entities that may elect to be a party to a hearing. We stated in the proposed rule that this has resulted in hearings for some appeals being difficult to schedule and taking longer to conduct due to multiple elections. To address these issues, we proposed at § 405.1010(d)(1) that when CMS or a contractor has been made a party to the hearing under § 405.1012, CMS or a contractor that elected to be a participant under § 405.1010 may not participate in the oral hearing, but may file a position paper and/or written testimony to clarify factual or policy issues in the case (oral testimony and attendance at the hearing would not be permitted). Similarly, we proposed at § 405.1010(d)(1) that CMS or a contractor that elected to be a party to the hearing, but was made a participant under § 405.1012(d)(1), as discussed below, would also be precluded from participating in the oral hearing, but would be permitted to file a position paper and/or oral testimony to clarify factual or policy issues in the case. We proposed at § 405.1010(d)(2) that if CMS or a contractor did not elect to be a party to the hearing under § 405.1012, but more than one entity elected to be a participant under § 405.1010, only the first entity to file a response to the notice of hearing as provided under § 405.1020(c) may participate in the oral hearing, but additional entities that filed a subsequent response to the notice of hearing could file a position paper and/or written testimony to clarify factual or policy issues in the case (though they would not be permitted to attend the hearing or provide oral testimony). We proposed that the first entity to file a response to the notice of hearing as provided under § 405.1020(c) may participate in the hearing for administrative efficiency. Under this approach, if multiple entities elected to participate in the proceedings prior to the issuance of a notice of hearing, in accordance with proposed § 405.1010(b)(1), any of these entities wishing to participate in the oral hearing would need to indicate this intention in the response to the notice of hearing. If more than one entity indicated its intention to attend and participate in the oral hearing, only the first entity to file its response would be permitted to do so. The remaining entities would be permitted only to file a position paper and/or written testimony (unless the ALJ grants leave to additional entities to attend the hearing, as discussed below). We considered an alternate proposal of the first entity that made an election to participate being given priority for participating in the hearing, but believed that would result in other participants being uncertain whether they will be participating in the hearing until as few as 5 days prior to the hearing. We also considered a process in which the ALJ would assess which participant that responded to the notice of hearing would be most helpful to the ALJ at the hearing, or in the alternative, permitting all participants to be at the hearing unless the ALJ determined a participant is not necessary for the hearing, but we were concerned that both of these approaches would add administrative burden to the ALJ and could result in participants and parties being uncertain of which participants will be at the hearing until shortly
Notwithstanding the limitations on CMS and CMS contractor participation in proposed § 405.1010(d)(1) and (2), we proposed in § 405.1010(d)(3) that the ALJ would have the necessary discretion to allow additional participation in the oral hearing when the ALJ determines an entity's participation is necessary for a full examination of the matters at issue. For example, we stated in the proposed rule that if an appeal involves LCDs from multiple MAC jurisdictions, the ALJ may determine that allowing additional MACs to participate in a hearing is necessary for a full examination of the matters at issue. Similarly, if an overpayment determined through the use of a statistical sample and extrapolation is at issue, the ALJ may determine that allowing the contractor that conducted the sampling to participate in the hearing is necessary to address issues related to the sampling and extrapolation, in addition to another contractor that made an election to clarify the policy and factual issues related to the merits of claims in the sample.
Currently, there are no provisions in § 405.1010 to address the possibility of CMS or a contractor making an invalid election. We proposed to revise § 405.1010(e) to add new provisions to establish criteria for when an election may be deemed invalid and provide standards for notifying the entity and the parties when an election is deemed invalid. We proposed in § 405.1010(e)(1) that an ALJ or attorney adjudicator may determine an election is invalid if the election was not timely filed or the election was not sent to the correct parties. We stated that this would help ensure that CMS and its contractors make timely elections and inform parties of elections. To provide notice to the entity and the parties that an election was deemed invalid, we proposed in § 405.1010(e)(2) to require a written notice of an invalid election be sent to the entity that submitted the election and the parties who are entitled to receive notice of the election. We proposed in § 405.1010(e)(2)(i) that if no hearing is scheduled for the appeal or the election was submitted after the hearing occurred, the notice of an invalid election would be sent no later than the date the decision, dismissal, or remand notice is mailed. We proposed in § 405.1010(e)(2)(ii) that if a hearing is scheduled for the appeal, the written notice of an invalid election would be sent prior to the hearing, and that if the notice would be sent fewer than 5 calendar days before the hearing is scheduled to occur, oral notice must be provided to the entity, and the written notice must be sent as soon as possible after the oral notice is provided.
Current § 423.2010 is similar to current § 405.1010, except that CMS, the IRE, or the Part D plan sponsor may only request to participate, and the time periods to request to participate are shorter than the time periods to elect to participate under § 405.1010, which provides the ALJ with time to consider the request to participate and make a determination on whether to allow participation by the entity. In addition, current § 423.2010 addresses participation in Part D expedited appeals. Like proposed § 405.1010(a), we proposed at § 423.2010(a) to provide CMS, the IRE, and the Part D plan sponsor with an opportunity to participate in the proceedings on a request for an ALJ hearing at two distinct points in the adjudication process, but the current policy of requiring the entity to request to participate is maintained. We proposed at § 423.2010(b)(3)(i) and (ii) that, if no hearing is scheduled, CMS, the IRE and/or the Part D plan sponsor would have an initial opportunity to request to be a participant in an appeal within 30 calendar days after notification that a standard request for hearing was filed with OMHA, or within 2 calendar days after notification that a request for an expedited hearing was filed. We stated in the proposed rule that the initial 30 calendar day period after notification that a standard request for hearing was filed with OMHA would be the same time frame provided under § 405.1010 for initial CMS and contractor elections, and we stated that we believed that the 30 calendar day period after notification that a request for hearing was filed is sufficient time for CMS, the IRE, and the Part D plan sponsor to determine whether to request to be a participant in the proceedings and for the request to be considered and granted or denied as the case is reviewed to determine whether a decision may be appropriate based on the record in accordance with § 423.2038. We also stated we believed the 2 calendar day period after notification that an expedited request for hearing was filed is a reasonable period of time for CMS, the IRE, or the Part D plan sponsor to determine whether to request to be a participant in the proceedings given the 10-day adjudication time frame. We proposed at § 423.2010(b)(3)(iii) and (iv) to provide a second opportunity to request to be a participant in an appeal if a hearing is scheduled. We proposed at § 423.2010(b)(3)(iii) that if a non-expedited hearing is scheduled, CMS, the IRE, or the Part D plan sponsor would continue to have 5 calendar days after receiving the notice of hearing to make the request. We proposed at § 423.2010(b)(3)(iv) that if an expedited hearing is scheduled, CMS, the IRE, or the Part D plan sponsor would continue to have 1 calendar day after receiving the notice of hearing to make the request. These time frames were carried over from current § 423.2010(b)(1) and (b)(3), and provide the ALJ with time to consider the request and notify the entity of his or her decision on the request to participate. As provided in current § 423.2010(a) and (g), we proposed at § 423.2010(a)(2) to provide that an ALJ may request but may not require CMS, the IRE, or the Part D plan sponsor to participate in any proceedings before the ALJ, including the oral hearing, if any, and that the ALJ may not draw any adverse inferences if CMS, the IRE, or the Part D plan sponsor declines to be a participant to the proceedings.
We proposed in § 423.2010(b) to adopt the standards governing how an election is made in proposed § 405.1010(b) in governing how a request to participate is made, except that an oral request to participate could be made for an expedited hearing, and OMHA would notify the enrollee of the request to participate in such cases.
Current § 423.2010(b)(2) and (b)(4) provide that an ALJ will notify an entity requesting to participate of the decision on the request within 5 calendar days for a request related to a non-expedited hearing, or 1 calendar day for a request related to an expedited hearing. We proposed to incorporate these time frames into proposed § 423.2010(c). In addition, we proposed in § 423.2010(c)(1) that if no hearing is scheduled, the notification is made at least 20 calendar days before the ALJ or attorney adjudicator (as proposed in section II.B of the proposed rule (and discussed in section II.A.2 above)) issues a decision, dismissal, or remand. This would provide the participant with time to submit a position paper in accordance with proposed § 423.2010(d)(3)(i), as discussed below. We also proposed to incorporate current § 423.2010(c) into proposed § 423.2010(c), so that the provision clearly states that the assigned ALJ or attorney adjudicator (as proposed in section II.B of the proposed rule (and
We proposed at § 423.2010(d) to consolidate current § 423.2010(d) through (f), to address the roles and responsibilities of CMS, the IRE, or the Part D plan sponsor as a participant. Specifically, we proposed at § 423.2010(d)(1) to generally incorporate current § 423.2010(d), which provides that participation may include filing position papers or providing testimony to clarify factual or policy issues, but it does not include calling witnesses or cross-examining a party's witnesses. However, we proposed in § 423.2010(d)(1) that participation may include filing position papers “and/or” providing testimony to emphasize that either or both may be done, and to remove the limitation that testimony must be written because participation may include providing oral testimony during the hearing. We proposed at § 423.2010(d)(2) to incorporate current § 423.2010(e), which provides that when participating in a hearing, CMS, the IRE, or the Part D plan sponsor may not be called as a witness during the hearing and, thus, are not subject to examination or cross-examination by the enrollee at the hearing. However, to be clear about how an enrollee and the ALJ may address statements made by CMS, the IRE, or the Part D plan sponsor during the hearing given that limitation, we also proposed in § 423.2010(d)(2) that the enrollee may rebut factual or policy statements made by the participant, and the ALJ may question the participant about its testimony.
We proposed at § 423.2010(d)(3) to incorporate current § 423.2010(f) with certain revisions as discussed below. Current § 423.2010(f) states that CMS, the IRE, and/or the Part D plan sponsor must submit any position papers within the time frame designated by the ALJ. We proposed in § 423.2010(d)(3) to include written testimony in the provision, establish deadlines for submission of position papers and written testimony that reflect the changes in participation requests in proposed 423.2010(b), and require that copies of position papers and written testimony be sent to the enrollee. Specifically, we proposed in § 423.2010(d)(3) that, unless the ALJ or attorney adjudicator grants additional time to submit a position paper or written testimony, a CMS, the IRE, or the Part D plan sponsor position paper or written testimony must be submitted within 14 calendar days for a standard appeal or 1 calendar day for an expedited appeal after receipt of the ALJ's or attorney adjudicator's decision on a request to participate if no hearing has been scheduled, or no later than 5 calendar days prior to a non-expedited hearing or 1 calendar day prior to an expedited hearing. We proposed to add “written testimony” to recognize that CMS, the IRE, or the Part D plan sponsor may submit written testimony as a participant, in addition to providing oral testimony at a hearing. We proposed to require that position papers and written testimony be submitted within 14 calendar days for a standard appeal or 1 calendar day for an expedited appeal after receipt of the ALJ's or attorney adjudicator's decision on a request to participate if no hearing has been scheduled to help ensure the position paper and/or written testimony are available when determinations are made to schedule a hearing or issue a decision based on the record in accordance with § 405.1038. We also proposed to require that if a hearing is scheduled, position papers and written testimony be submitted no later than 5 calendar days prior to a non-expedited hearing or 1 calendar day prior to an expedited hearing (unless the ALJ grants additional time) to help ensure the ALJ and the enrollee have an opportunity to review the materials prior to the hearing. Similar to proposed § 405.1010(c)(3)(iii), we also proposed at § 423.2010(d)(3)(ii) that a copy of the position paper or written testimony must be sent to the enrollee, and at § 423.2010(d)(iii) that a position paper or written testimony would not be considered in deciding an appeal if CMS, the IRE, and/or the Part D plan sponsor fails to send a copy of the position paper or written testimony to the enrollee or fails to submit the position paper or written testimony within the established time frames. This would help ensure CMS, IRE, or Part D plan sponsor position papers and written testimony are submitted timely and shared with the enrollee.
Currently, there are no provisions in § 423.2010 to address the possibility of CMS, the IRE, and/or the Part D plan sponsor making an invalid request to participate. We proposed to revise § 423.2010(e) to add new provisions to establish criteria for when a request to participate may be deemed invalid and provide standards for notifying the entity and the enrollee when a request to participate is deemed invalid. We proposed in § 423.2010(e)(1) that an ALJ or attorney adjudicator may determine a request to participate is invalid if the request to participate was not timely filed or the request to participate was not sent to the enrollee. We stated that this would help ensure that CMS, the IRE, and/or the Part D plan sponsor make timely requests to participate and inform the enrollee of requests. To provide notice to the entity and the enrollee that a request to participate was deemed invalid, we proposed in § 423.2010(e)(2) to require that a written notice of an invalid request be sent to the entity that made the request and the enrollee. We proposed in § 423.2010(e)(2)(i) that if no hearing is scheduled for the appeal or the request was made after the hearing occurred, the notice of an invalid request would be sent no later than the date the decision, dismissal, or remand order is mailed. We proposed in § 423.2010(e)(2)(ii) that if a non-expedited hearing is scheduled for the appeal, written notice of an invalid request would be sent prior to the hearing, and that if the notice would be sent fewer than 5 calendar days before the hearing, oral notice must be provided to the entity, and the written notice must be sent as soon as possible after the oral notice is provided. We proposed in § 423.2010(e)(2)(iii) that if an expedited hearing is scheduled for the appeal, oral notice of an invalid request must be provided to the entity, and the written notice must be sent as soon as possible after the oral notice is provided. We proposed to require the oral notice for expedited hearings because the very short time frames involved in expedited hearing proceedings often do not allow for delivery of a written notice and the oral notice will help ensure the entity is made aware of the invalid request prior to the hearing.
Current § 405.1012(a) states that CMS and/or its contractors may be a party to an ALJ hearing unless the request for hearing is filed by an unrepresented beneficiary. Current § 405.1012(b) states
Current § 405.1012 does not limit the number entities that may elect to be a party to the hearing. We stated in the proposed rule that this has resulted in hearings for some appeals being difficult to schedule and taking longer to conduct due to multiple elections. To address these issues, we proposed at § 405.1012(a)(1), except as provided in proposed paragraph (d) discussed below, to only allow either CMS or one of its contractors to elect to be a party to the hearing (unless the request for hearing is filed by an unrepresented beneficiary, which precludes CMS and its contractors from electing to be a party to the hearing). Current § 405.1012(b) states that CMS or a contractor advises the ALJ, appellant, and all other parties identified in the notice of hearing that it intends to participate as a party no later than 10 calendar days after receiving the notice of hearing. We proposed at § 405.1012(a) to incorporate and revise a portion of current § 405.1012(b), to require that an election to be a party must be filed no later than 10 calendar days after the QIC receives the notice of hearing, because notices of hearing are sent to the QIC in accordance with § 405.1020(c) (the remaining portion of current § 405.1012(b) is incorporated with revisions into proposed § 405.1012(b), as discussed below).
Current § 405.1012 does not have a provision similar to current § 405.1010(a), which states that an ALJ may request that CMS and/or one or more of its contractors participate in the proceedings, but current § 405.1012(d) does provide that the ALJ may not require CMS or a contractor to enter a case as a party or draw any adverse inference if CMS or a contractor decided not to enter as a party. In practice, ALJs do at times request that CMS or a contractor elect to be a party to the hearing, in conjunction with a request for participation under current § 405.1010(a). To align the provisions and reflect ALJ practices, we proposed at § 405.1012(a)(2) to state that an ALJ may request but not require CMS and/or one or more of its contractors to be a party to the hearing. We also proposed in § 405.1012(a)(2) to incorporate current § 405.1012(d) to provide that that an ALJ cannot draw any adverse inferences if CMS or a contractor decides not to enter as a party.
We proposed at § 405.1012(b) to address how CMS or a contractor elects to be a party to the hearing. We proposed to follow the same process in current § 405.1012(b) so that under proposed § 405.1012(b), CMS or the contractor would be required to send written notice of its intent to be a party to the hearing to the ALJ and the parties identified in the notice of hearing, which includes the appellant.
We proposed to set forth the roles and responsibilities of CMS or a contractor as a party in § 405.1012(c). Proposed § 405.1012(c)(1) would incorporate current § 405.1012(c) with some changes in wording, both of which provide that as a party to the hearing, CMS or a contractor may file position papers, submit evidence, provide testimony to clarify factual or policy issues, call witnesses, or cross-examine the witnesses of other parties. We proposed in § 405.1012(c)(2) to include written testimony, such as an affidavit or deposition, in the provision; establish deadlines for submission of position papers, written testimony, and evidence; and require that copies of position papers, written testimony, and evidence be sent to the parties that were sent a copy of the notice of hearing. Specifically, we proposed in § 405.1012(c)(2)(i) and (c)(2)(ii) that any position papers, written testimony, and evidence must be submitted no later than 5 calendar days prior to the hearing, unless the ALJ grants additional time to submit the materials, and copies must be sent to the parties who were sent a copy of the notice of hearing. We proposed to add “written testimony” to recognize that CMS or a contractor may submit written testimony, in addition to providing oral testimony at a hearing. We also proposed to require that position papers, written testimony, and/or evidence be submitted no later than 5 calendar days prior to the hearing (unless the ALJ grants additional time), and that copies be submitted to the parties sent notice of the hearing, to help ensure the ALJ and the parties have an opportunity to review the materials prior to the hearing. Current § 405.1012 does not address the consequence of failure to submit a position paper or evidence in accordance with the section. We proposed in § 405.1012(c)(2)(iii) that a position paper, written testimony, and/or evidence would not be considered in deciding an appeal if CMS or a contractor fails to send a copy of its position paper, written testimony, and/or evidence to the parties or fails to submit the position paper, written testimony, and/or evidence within the established time frames. We stated in the proposed rule that this would help ensure CMS or contractor position papers and evidence are submitted timely and shared with the parties.
As discussed above, current § 405.1012 does not limit the number of entities (that is, CMS and its contractors) that may elect to be a party to the hearing and, as also discussed above, we proposed to revise § 405.1010 and 405.1012 to limit the number of entities that participate in a hearing unless an ALJ determines that an entity's participation is necessary for a full examination of the matters at issue. We proposed to revise § 405.1012(d)(1) to provide that if CMS and one or more contractors, or multiple contractors file elections to be a party to a hearing, the first entity to file its election after the notice of hearing is issued is made a party to the hearing and the other entities are made participants in the proceedings under § 405.1010, subject to § 405.1010(d)(1) and (3) (and as such may file position papers and provide written testimony to clarify factual or policy issues in the case, but may not participate in the oral hearing unless the ALJ grants leave to the entity to participate in the oral hearing in accordance with § 405.1010(d)(3)). Similar to proposed § 405.1010(d)(3), we also proposed in § 405.1012(d)(2) that, notwithstanding the limitation in proposed § 405.1012(d)(1), an ALJ may grant leave for additional entities to be parties to the hearing if the ALJ determines that an entity's participation as a party is necessary for full examination of the matters at issue.
We stated in the proposed rule that we believed allowing the first entity to file an election after a notice of hearing is issued to be a party to the hearing is administratively efficient and provides an objective way to determine which entity is made a party based on the competing elections, while providing an opportunity to participate in the appeal
Finally, we proposed to add new § 405.1012(e) to address the possibility of CMS or a contractor making an invalid election. Proposed § 405.1012(e)(1) would provide that an ALJ or attorney adjudicator may determine an election is invalid if the request for hearing was filed by an unrepresented beneficiary, the election was not timely, the election was not sent to the correct parties, or CMS or a contractor had already filed an election to be a party to the hearing and the ALJ did not determine that the entity's participation as a party is necessary for a full examination of the matters at issue. We stated that this would help ensure that CMS and its contractors make timely elections and inform parties of elections, and also provide a mechanism to address an election when the request for hearing was filed by an unrepresented beneficiary or when another entity has already filed an election to be a party to the hearing. To provide notice to the entity and the parties that an election was deemed invalid, we proposed in § 405.1012(e)(2) to require that a written notice of an invalid election be sent to the entity that made the election and the parties who were sent the notice of hearing. We proposed in § 405.1012(e)(2)(i) that if the election was submitted after the hearing occurred, the notice of an invalid election would be sent no later than the date the decision, dismissal, or remand notice is mailed. We proposed in § 405.1012(e)(2)(ii) that if the election was submitted before the hearing occurs, the written notice of invalid election would be sent prior to the hearing, and that if the notice would be sent fewer than 5 calendar days before the hearing is scheduled to occur, oral notice would be provided to the entity that submitted the election, and the written notice to the entity and the parties who were sent the notice of hearing would be sent as soon as possible after the oral notice is provided.
Provided below are summaries of the specific comments we received relating to our proposed revisions to §§ 405.1010, 405.1012, and 423.2010, and responses to these comments. Because many commenters submitted comments that touched on all three proposals, we are collectively addressing in this section comments that related to sections III.A.3.f.i, ii, and iii of the proposed rule:
While the interest of administrative efficiency supports limiting participation at the oral hearing, we do not believe the same rationale applies to position papers and written testimony. The submission of position papers and written testimony adds minimal burden to the appeals process, may assist with clarifying facts and policy, and allows for a fuller presentation of the appeal. While it is possible that there may be some repetition in the written submissions, we believe that there is potential added value in permitting contractors to submit position papers and written testimony for consideration in this situation.
With respect to the commenter's concern that the contractor permitted to participate in the oral hearing may not have access to information on the beneficiaries and claims from other DME MAC jurisdictions and could not present any argument or defense for those denials, we note that even when a contractor is not permitted to participate in the oral hearing under § 405.1010(d)(1), the contractor can still submit position papers and written testimony, which may provide helpful information to the contractor participating in the oral hearing. However to help further ensure that CMS or a CMS contractor that has elected party status is able to fully represent the position of CMS in cases where the entity that elected party status does not have information on all beneficiaries or claims involved, or where the entity that has elected party status deems it necessary to call another CMS contractor as a witness, we are amending proposed § 405.1010(d)(3) to provide that CMS or a contractor that is precluded from participating in the oral hearing under paragraph § 405.1010(d)(1) may still be called as a witness by CMS or a contractor that is a party to the hearing in accordance with § 405.1012. We expect the need for CMS or a contractor as a party to call another CMS contractor as a witness would be an infrequent occurrence, and believe this approach strikes the appropriate balance between administrative efficiency and addressing the commenter's concerns.
With respect to the commenter's concern that position papers and written testimony will be inadequate to refute arguments that are made at the hearing, we note that the role of participants, both in written submissions and participating in the oral hearing, is to provide testimony to clarify factual or policy issues, and does not include calling witnesses or cross-examining the witness of a party to the hearing. In addition, we believe that CMS and its contractors are already familiar with the appellant's arguments based on the contractors' review of the record and involvement in the lower-level appeal decisions or the initial determination. Accordingly, we believe that contractors have generally set forth their positions on those arguments in the lower-level decisions or will have an
As discussed in the comment summary above, we considered alternatives to the proposed rule that the first entity to file a response to a notice of hearing be given priority for participating at the hearing, however we decided that giving the first entity priority is administratively efficient and provides an objective and clear way of determining which contractor is allowed to participate at the oral hearing. We do not agree with the commenter that OMHA should give priority to MACs and QICs over RAs as we believe, from our experience and from feedback we received from stakeholders, that there are valid and equal arguments why each of these entities' participation may be valuable in the proceedings. We again note that § 405.1010(d)(3), as finalized in this rule, would allow the ALJ to permit multiple participants to attend the hearing if the participation of multiple entities at the hearing would be necessary for a full examination of the matters at issue.
Pursuant to § 405.1020(c)(1) (as finalized in this rule), if a hearing is scheduled, the ALJ would send notice of the hearing to the QIC, to CMS and any contractor that the ALJ believes would be beneficial to the hearing, and, as discussed below, to CMS or any contractor that elected to participate in the proceedings in accordance with § 405.1010(b). Therefore, if a contractor has elected to participate in the proceedings before a notice of hearing has been sent, under § 405.1020(c)(1), if a hearing is ultimately scheduled that entity will receive a copy of the notice of hearing directly from OMHA. While contractors not specified in § 405.1020(c)(1) will not receive a copy of the notice of hearing directly from OMHA, we believe that limiting the number of notices provided to those entities specified in § 405.1020(c)(1) is necessary to minimize the administrative burden on OMHA. Further, we do not believe that limiting the number of notices will compromise the interests of contractors because we plan to issue sub-regulatory guidance, including educational materials and contractual modifications that will establish processes to accommodate the regulatory changes. These processes will relate to timely notice, information sharing, and coordination among affected contractors that may have an interest in participating in the same hearing. CMS will begin the process of issuing sub-regulatory guidance and contractual modifications after the effective date of this final rule.
Finally, we disagree with the commenter's suggestion that when CMS or a contractor fails to provide requested position papers and/or written testimony that it will have a significant impact on the appeal. First, if an ALJ or attorney adjudicator believes that the written record is missing information that is essential to resolving the issues on appeal and that information can be provided only by CMS or its contractors, the information may be requested from the QIC that conducted the reconsideration or its successors under § 405.1034, as finalized in this rule. Second, CMS or its contractors will likely elect participation or party status in those appeals that involve more complex issues of fact or law and where their participation or party status will be most useful. Finally, while position papers and/or written testimony submitted by CMS or its contractors may be helpful in clarifying factual issues or policy, we do not believe that the failure to submit position papers or written testimony is likely to result in any negative impact on the appellant or other parties. The appellant and other parties obviously may still present their full testimony and arguments and the ALJ or attorney adjudicator will consider evidence in the administrative record as appropriate, including all administrative proceedings, prior to issuing a decision.
In response to the commenter's question regarding acceptable forms of communication, § 423.2010(b)(1), as finalized in this rule, provides that, if the Part D plan sponsor requests participation before it receives notice of hearing, or when no notice of hearing is required, the Part D Plan “must send written notice of its request to
Proposed § 405.1010 does not address the mechanisms for assignment of cases to OMHA adjudicators. OMHA's case assignment process is subject to the priority of the case (to help ensure appeals filed by beneficiaries are adjudicated as quickly as possible, OMHA designates these appeals as priority appeals, with some exceptions), OMHA's pending workload, and the availability of an adjudicator. More details on the OMHA case assignment process are available in the OCPM, which is accessible on the OMHA Web site (
Similarly, proposed § 405.1010 does not address the length of time between when an appeal is filed and when a hearing date will be selected. The length of time between when an appeal is filed and when a hearing date is selected will vary based on how quickly the case is assigned to an OMHA ALJ, because only OMHA ALJs may conduct hearings, and the assigned ALJ's availability and docket of other cases. Because this time is subject to significant variation based on the stated factors, we cannot provide a generally applicable estimate.
If and when a hearing is scheduled, the ALJ will issue a notice of hearing consistent with § 405.1022 to the parties and other potential participants provided for in § 405.1020(c), including, among others, to the QIC that issued the reconsideration and CMS or any contractor that the ALJ believes would be beneficial to the hearing. In consideration of the commenter's question regarding when and how the DME MAC will become aware of the hearing date if the request for hearing is only sent to the QIC that issued the reconsideration, DME MACs and other non-QIC contractors would be notified of the hearing date by the QIC that issues the reconsideration in accordance with CMS instructions to QICs for notifying other contractors of a scheduled ALJ hearing. However, we believe it is also appropriate for the notice of hearing to be sent to CMS or any contractor that elected to participate in the proceedings consistent with § 405.1010(b), and we are revising our proposal at § 405.1020(c)(1) to require this. Thus, a non-QIC contractor will receive notice of the hearing either directly from OMHA, if the contractor has elected to participate before receipt of a notice of hearing or if the ALJ believes the non-QIC contractor would be beneficial to the hearing, or it will receive notice of the hearing from the QIC if it elects to participate after notice of hearing is sent.
Section 405.1012(d)(1), as finalized in this rule, limits party status at the oral hearing to the first entity to elect party status after the notice of hearing is issued, but any other entity that filed an election for party status is made a participant in the proceedings under proposed § 405.1010 (subject to § 405.1010(d)(1) and (3)), and may file a position paper and/or written testimony to clarify factual or policy issues in the case. We believe that allowing a contractor that is precluded from being a party to the hearing to file positions papers and/or written testimony still provides the contractor with a meaningful opportunity to participate in the proceedings. As we explained in the proposed rule, we considered alternatives to the first to file provision in proposed § 405.1012(d)(1). However, we believe that providing that the first entity to elect party status be made a party to the hearing is an administratively efficient and objective method of determining which contractor will be made a party to the hearing if more than one entity makes a party election. We do not agree with the commenter that the first contractor to deny the claim is necessarily the best entity or the most beneficial entity to have at the hearing. In some cases, subsequent contractors may have resolved the issue identified by the first contractor and further developed the record, and that subsequent contractor may have a more current understanding of the issues on appeal and the facts. In addition, when multiple contractors would be necessary for a full examination of the matters at issue, §§ 405.1010(d)(3) and 405.1012(d)(2) as finalized could be used by the ALJ to grant leave to a precluded entity to participate in the oral hearing or to be a party to the hearing, respectively. Although the commenter suggested that as an alternative, multiple parties should always be permitted to participate at the oral hearing and the ALJ could use his or her discretion to limit testimony and argument as necessary, we believe that the process finalized in this final rule is more efficient and provides more clarity regarding expectations.
We also disagree with the commenter's characterization of the process for CMS or its contractor to elect to be a party to the hearing as “new” to the extent that § 405.1012(b), as finalized in this rule, follows the same process in current § 405.1012(b) for electing party status by sending written notice of intent to be a party to the hearing to the ALJ and the parties identified in the notice of hearing, which includes the appellant. Although § 405.1012(d), as finalized in this rule, places a new limitation on the number of contractors who have elected to be a party that may participate in the oral hearing, unless the ALJ grants leave to an entity to also be a party to the hearing, we do not believe this process imposes an additional administrative burden or time-consuming step. Section 405.1012(d)(2) states that if CMS or a contractor is precluded under the rules from being a party to a hearing, an ALJ may grant leave for CMS or a contractor to be a party to the hearing if the ALJ determines that the entity's participation as a party is necessary for a full examination of the matters at issue. We disagree that this determination by the ALJ imposes any cumbersome, time-consuming, or administratively burdensome requirements on CMS of its contractors. While the commenter has characterized the process as requiring that entities “seek permission from the ALJ to act as a party to the hearing,” we do not agree that § 405.1012(d)(2), as finalized in this rule, necessarily requires any additional filings or actions from the entity other than the written notice of intent to participate as a party provided for in § 405.1012(b).
With respect to the commenter's concern regarding audit contractors' ability to meet contractual obligations, including the concern that QICs may preemptively elect party status and preclude participation or party status for audit contractors, we direct the commenter to our response to a similar comment above that was submitted by a QIC. As we noted above, after the final rule is effective, we intend to issue sub-regulatory guidance, including educational materials and contractual modifications that will establish processes to accommodate the regulatory changes and help ensure contractor understanding of roles and responsibilities. These processes will relate to timely notice, information
Finally, we recognize that there may be some delay in certain contractors' receipt of the notice of hearing as it is processed through the QICs. However, we believe that the 10 calendar day time frame still provides adequate time to give notice to all contractors. The timeframe for forwarding a notice of hearing is reflected in the QIC contracts. CMS will take steps to help ensure that the QICs and other contractors follow the applicable regulations and contractual requirements. Because the QICs' contractual obligations already reflect a workable timeframe, and because CMS will take steps to help ensure that the QICs follow those contractual obligations, we do not agree that the first two alternatives suggested by the commenter—revising the regulations to extend the time frame to elect party status to 20 days or extending the timeframe to elect party status if a QIC fails to timely notify contractors of the receipt of a notice of hearing—are necessary. We believe that the commenter's third suggestion of requiring that OMHA always send the notice of hearing to all contractors places an unnecessary administrative burden on OMHA and would duplicate the process for notifying the various contractor entities that is already managed by CMS through the QICs' contracts. As we noted above, after the final rule is effective, we intend to issue sub-regulatory guidance that will establish processes to accommodate the regulatory changes. CMS will begin the process of modifying contract provisions with regards to notices of hearing after the effective date of this final rule. In addition, we note that any contractor, including an audit contractor, that has elected to participate in the proceedings on a request for an ALJ hearing under § 405.1010 will receive notice of a hearing, if one is scheduled, directly from OMHA pursuant to § 405.1020(c)(1) as finalized in this rule.
After review and consideration of the comments received, for the reasons discussed above and in the proposed rule, we are finalizing these changes to §§ 405.1010, 405.1012, and 423.2010 as proposed, with the following modifications. We are adding a requirement in §§ 405.1010(c)(3)(ii), 405.1012(c)(2)(ii) and 423.2010(d)(3)(ii) that copies of position papers and/or written testimony (and for purposes of § 405.1012(c)(2)(ii), any evidence) submitted to OMHA must be sent to the other parties within the same timeframes that apply to the submissions to OMHA. In addition, we are adding language to § 405.1010(d)(3) to state that if the ALJ does not grant leave to the precluded entity to participate in the oral hearing, the precluded entity may still be called as a witness by CMS or a contractor that is a party to the hearing in accordance with § 405.1012. To accommodate this change, we are also revising § 405.1010(c)(2) to state that when CMS or its contractor participates in an ALJ hearing, CMS or its contractor may not be called as a witness during the hearing and is not subject to examination or cross-examination by the parties, except as provided in § 405.1010(d)(3). We are also adding clarifying language in § 405.1012(a)(2) that an ALJ may not request that CMS and/or one or more of its contractors be a party to the hearing if the request for hearing was filed by an unrepresented beneficiary. Finally, we are correcting a drafting error in the text of proposed § 405.1010(c)(3)(i) by replacing “by within 14 calendar days” with “within 14 calendar days.”
Sections §§ 405.1014 and 423.2014 explain the requirements for requesting an ALJ hearing, including what must be contained in the request, when and where to file the request, the extension of time to request a hearing, and in § 405.1014 to whom a copy of the request for hearing must be sent. We proposed to restructure the sections, clarify and provide additional instructions, and address other matters that have caused confusion for parties and adjudicators. 81 FR 43790, 43816-43820.
We proposed to revise the title and provisions of §§ 405.1014 and 423.2014 to more clearly cover a request for a review of a QIC or IRE dismissal. While the current requirements for requesting an ALJ hearing are generally used for requesting a review of a QIC or IRE dismissal in form HHS-725, we stated in the proposed rule that we believe that explicitly extending §§ 405.1014 and 423.2014 to cover requests for these types of review would provide clarity to parties and adjudicators on the requirements for requesting a review of a QIC or IRE dismissal. As such, we proposed in the title to § 405.1014 and in subsection (a)(1) (current subsection (a)) to add “or a review of a QIC dismissal” after “ALJ hearing,” and in subsection (c) (current subsection (b)) to delete “after a QIC reconsideration” and add “or request for review of a QIC dismissal” after “an ALJ hearing.” Similarly, we proposed in the title to § 423.2014 and in subsection (a)(1) (current subsection (a)) to add “or a review of an IRE dismissal” after “ALJ hearing,” and in subsection (d) (current subsection (c)) to add “or request for review of an IRE dismissal” after “IRE reconsideration.”
We proposed in § 405.1014(a)(1)(i) through (a)(1)(vi) to incorporate current § 405.1014(a)(1) through (a)(6) with revisions. In addition to the current requirements in subsection (a)(1), we proposed in § 405.1014(a)(1)(i) to require the beneficiary's telephone number if the beneficiary is the filing party and is not represented. We stated in the proposed rule that this would help ensure that OMHA is able to make timely contact with the beneficiary to clarify his or her filing, or other matters related to the adjudication of his or her appeal, including scheduling the hearing. We proposed in § 405.1014(a)(1)(ii) to require the appellant's telephone number, along with the appellant's name and address as currently required in subsection (a)(2), when the appellant is not the beneficiary, and in § 405.1014(a)(1)(iii) to require a representative's telephone number, along with the representative's name and address which is currently included in subsection (a)(3), if a representative is involved. Like the beneficiary telephone number requirement, we stated that these requirements would help ensure that OMHA is able to make timely contact with a non-beneficiary appellant and any representative involved in the appeal to clarify the filing or other matters related to the adjudication of the appeal, including scheduling the hearing. Current subsection (a)(4) states that the request must include the document control number assigned to the appeal by the QIC, if any. We proposed in § 405.1014(a)(1)(iv) to require the Medicare appeal number or document control number, if any, assigned to the QIC reconsideration or dismissal notice being appealed, to reduce confusion for appellants. We proposed in § 405.1014(a)(1)(v) to add
We proposed to add a new requirement to the content of the request in § 405.1014(a)(1)(vii) by requiring a statement of whether the filing party is aware that it or the claim is the subject of an investigation or proceeding by the OIG or other law enforcement agencies. We stated that this information is necessary to assist OMHA staff in checking whether the provider or supplier was excluded from the program on the date of service at issue prior to scheduling a hearing or issuing a decision, as well as for the ALJ to determine whether to request the participation of CMS or any program integrity contractors that may have been involved in reviewing the claims below. However, we noted that the information is only required if the filing party is aware of an investigation and proceeding, and the information would not be the basis for a credibility determination on evidence or testimony, as an investigation or allegations prior to findings of wrongdoing by a court of competent jurisdiction are not an appropriate foundation for credibility determinations in the context of part 405, subpart I administrative appeals.
As discussed in section III.A.3.d of the proposed rule and II.B.3.d of this final rule above, we proposed changes to the methodology for calculating the amount in controversy required for an ALJ hearing to better align the amount in controversy with the actual amount in dispute. We also proposed new § 405.1014(a)(1)(viii) to require that providers, suppliers, Medicaid State agencies, applicable plans, and beneficiaries represented by a provider, supplier, or Medicaid State agency include in their request for hearing the amount in controversy applicable to the disputed claim, as specified in § 405.1006(d), unless the matter involves a provider or supplier termination of Medicare-covered items or services that is disputed by a beneficiary, and the beneficiary did not elect to continue receiving the items or services. As we discussed in section III.A.3.d of the proposed rule and II.B.3.d of this final rule above, we stated that in instances where the Medicare allowable amount would serve as the basis for the amount in controversy (which we believe would be the majority of Part B appeals), we believe providers, suppliers, and Medicaid State agencies would be able to utilize existing CMS tools and resources to determine the allowable amount used as the basis for the amount in controversy under proposed § 405.1006(d)(2)(i)(A) and arrive at the amount in controversy after deducting any Medicare payments that have already been made or awarded and any deductible and/or coinsurance that may be collected for the items and services in the disputed claim. In addition, we stated that we believe that providers, suppliers, applicable plans, and Medicaid State agencies also would have access to the billing, payment and other necessary information to calculate the amount in controversy under other provisions of § 405.1006(d). For scenarios where the basis for the amount in controversy would be calculated in accordance with proposed § 405.1006(d)(2)(i)(B), (ii), (iii), or where the amount in controversy would be calculated in accordance with § 405.1006(d)(3), (5), (6), or (7), we discussed in section III.A.3.d of the proposed rule and II.B.3.d of this final rule above how appellants would determine the amount in controversy in order to include it on their request for hearing. However, we stated that because we believe there may be instances where a beneficiary who is not represented by a provider, supplier, or Medicaid State agency may not have the information necessary to determine the amount in controversy under § 405.1006(d) (as discussed above), we did not propose to require beneficiaries who are not represented by a provider, supplier, or Medicaid State agency to include the amount in controversy in their requests for hearing. Furthermore, as noted above, we did not propose that any appellant include the amount in controversy on requests for hearing where the amount in controversy would be calculated in accordance with § 405.1006(d)(4) (for a provider or supplier termination of Medicare-covered items or services that is disputed by a beneficiary, and the beneficiary did not elect to continue receiving the items or services). We stated that we expected in this situation, a beneficiary could easily determine whether the minimum amount in controversy required for an ALJ hearing would be met through a conversation with the provider or supplier, or from the statement we proposed that the QIC include in its notice of reconsideration as discussed in section III.A.3.d of the proposed rule and II.B.3.d of this final rule above. However, we stated that we believe the exact amount in controversy could be difficult to determine because it may depend on unknown factors, such as the length of continued services that may be required, and so we are not requiring appellants to include this amount in the request for hearing.
Lastly, we proposed that current § 405.1014(a)(7), which requires a statement of any additional evidence to be submitted and the date it will be submitted, would be separately designated in its entirety as proposed § 405.1014(a)(2) because the information in proposed § 405.1014(a)(1) must be present for a request for hearing to be processed and therefore would make the request subject to dismissal if the information is not provided, as discussed below. In contrast, we stated that the information in proposed § 405.1014(a)(2) is only necessary if evidence would be submitted and would not make the request subject to dismissal if not present in the request.
Similar to proposed § 405.1014(a), we proposed at § 423.2014(a)(1)(i) through (a)(1)(vi) to incorporate current § 423.2014(a)(1) through (a)(6) with revisions. Current subsection (a)(3) states that the request must include the appeals case number assigned to the appeal by the IRE, if any. We proposed in § 405.1014(a)(1)(iii) to revise the requirement to state that the request must include the Medicare appeal number, if any, assigned to the IRE reconsideration or dismissal being appealed, to reflect the terminology used by the IRE and thereby reduce confusion for enrollees. Current subsection (a)(6) states that the request must include the reasons the enrollee disagrees with the IRE's reconsideration. We proposed to insert “or dismissal” after “reconsideration” to again reflect the terminology used by the IRE and thereby reduce confusion for enrollees. For the same reasons as we proposed for § 405.1014(a)(1)(vii), we proposed at § 423.2014(a)(1)(vii) to require a statement of whether the enrollee is aware that he or she, or the prescription for the drug being appealed, is the subject of an investigation or proceeding by the OIG or other law enforcement agencies. In addition, we proposed at § 423.2014(a)(2) to incorporate the current § 423.2014(a)(7) requirement to include a statement of any additional evidence to be submitted and the date it will be submitted, and at § 423.2014(a)(3) to incorporate the current § 423.2014(a)(8) requirement to include a statement that the enrollee is
Provided below are summaries of the specific comments received and responses to these comments:
After review and consideration of the comments received, for the reasons discussed above and in the proposed rule, we are finalizing these changes to §§ 405.1014 and 423.2014 as proposed, with the following exceptions. We are not finalizing proposed §§ 405.1014(a)(1)(vii), (viii), and 423.2014(a)(1)(vii).
We proposed to add new § 405.1014(a)(3) to address appeals in which an appellant raises issues regarding a statistical sampling methodology and/or an extrapolation that was used in making an overpayment determination. We stated in the proposed rule that OMHA has encountered significant issues when an appellant challenges aspects of a statistical sampling methodology and/or the results of extrapolations in separate appeals for each sampled claim involved in the statistical sampling and/or extrapolation. We stated that appeals often need to be reassigned to avoid multiple adjudicators addressing the challenges to the statistical sampling methodology and/or extrapolation, and any applicable adjudication time frames that attach to the individual appeals. Under proposed § 405.1014(a)(3), if an appellant is challenging the statistical sampling methodology and/or extrapolation, the appellant's request for hearing must include the information in proposed § 405.1014(a)(1) and (a)(2) for each sample claim that the appellant wishes to appeal, be filed within 60 calendar days of the date that the party received the last reconsideration for the sample claims (if they were not all addressed in a single reconsideration), and assert the reasons the appellant disagrees with the statistical sampling methodology and/or extrapolation in the request for hearing. We stated in the proposed rule that we believed it would be appropriate in this situation to allow the appellant's request for hearing to be filed within 60 calendar days of the date that the party received the last reconsideration for the sample claims (if they were not all addressed in a single reconsideration), because if the appellant also wishes to challenge the statistical sampling methodology and/or extrapolation, the appellant would wait to file a request for hearing until all of the QIC reconsiderations for the sample units are received, which could be more than 60 calendar days after the first received QIC reconsideration of one of the sample claims. We also stated that the 60 calendar day period in proposed § 405.1014(a)(3)(ii) would begin on the date the party receives the last reconsideration of a sample claim, regardless of the outcome of the claim in the reconsideration or whether the sample claim is appealed in the request for hearing. We stated we believed proposed § 405.1014(a)(3) would balance the party's rights to request a hearing on individual claims when only the sample claims are appealed, with the needs to holistically address issues related to statistical sampling methodologies and extrapolations when those determinations are also challenged. We did not propose any corresponding changes to § 423.2014 because sampling and extrapolation are not currently used in Part D appeals.
Provided below are summaries of the specific comments received and responses to these comments:
Section 405.1014(a)(3)(iii), as finalized, requires an appellant to include in the request for hearing the reasons the appellant disagrees with the statistical sampling methodology and/or extrapolation. If an appellant is unable to summarize the reasons he or she disagrees with the statistical sampling methodology and/or extrapolation in a format suitable for a request for hearing, the appellant may choose to attach a position paper or other documentation to the request for hearing to better explain the reasons for the challenge. We also note that the requirement to include the reasons the appellant disagrees with how the statistical sample and/or extrapolation was conducted does not limit the appellant's ability to provide additional information or arguments during the course of the appeal. The requirement, which is similar to the existing requirement in § 405.1014 to state the reasons the appellant disagrees with the QIC's reconsideration or other determination being appealed, provides the adjudicator with information on the appellant's basis for the appeal and is necessary to evaluate the record and prepare for the hearing. Moreover, a request for hearing may not be dismissed as incomplete based on the strength of the appellant's reasons for disagreeing with the statistical sampling methodology and/or extrapolation; a dismissal for an incomplete request would only result if no reason were provided, and only after an opportunity to cure the request had been provided,
After review and consideration of the comments received, for the reasons discussed above and in the proposed rule, we are finalizing § 405.1014(a)(3) as proposed without modification.
There has been considerable confusion on the implications of not providing the information required by current § 405.1014(a) in order to perfect a request for hearing, and significant time and resources have been spent on this procedural matter by parties, OMHA, and the Council. To provide clearer standards and reduce confusion, we proposed in § 405.1014(b)(1) that a request for hearing or request for a review of a QIC dismissal must contain the information specified in proposed § 405.1014(a)(1) to the extent the information is applicable, in order to be considered a complete request, and that any applicable adjudication time frame will not begin until the request is complete because the missing information is necessary to the adjudication of the appeal. We proposed in § 405.1014(b)(1) to also provide an appellant with an opportunity to complete any request found to be is incomplete. However, we proposed that if the appellant fails to provide the information necessary to complete the request in the time frame provided, the incomplete request would be dismissed in accordance with proposed § 405.1052(a)(7) or (b)(4). In order to reinforce the concept that an appellant's request and supporting materials is considered in its totality, we also proposed at § 405.1014(b)(2) to allow for consideration of supporting materials submitted with a request when determining whether the request is complete, provided the necessary information is clearly identifiable in the materials. For example, we stated in the proposed rule that if an appellant were to submit a request for hearing and included a copy of the QIC reconsideration, the Medicare appeal number on the QIC reconsideration would generally satisfy the subsection (a)(1)(iv) requirement because it clearly provides the required information. However, if there are multiple claims in the QIC reconsideration, the same document possibly would not satisfy subsection (a)(1)(v) because the appellant is not required to appeal all partially favorable or unfavorable claims, and subsection (a)(1)(v) requires the appellant to indicate the dates of service for the claims that are being appealed. Similarly, we stated that including medical records only for the dates of service that the appellant wishes to appeal would generally not satisfy subsection (a)(1)(v) because it would be unclear whether the appellant intended to limit the appeal to only those dates of service for which medical records were included, or those were the only dates of service for which the appellant had medical records. We proposed that the provisions of proposed § 405.1014(b) also be adopted in proposed § 423.2014(c) for requesting an ALJ hearing or a review of an IRE dismissal in Part D appeals.
Provided below is a summary of the specific comment received and our response to this comment:
Allowing for consideration of supporting materials when determining whether a request is complete would also provide ALJs and attorney adjudicators with additional flexibility to deem the request complete, even if all of the information necessary for a complete request is not contained on the same document. We believe the rules as finalized provide all appellants, including unrepresented beneficiaries, with an appropriate level of flexibility in providing that the all documents submitted with a request for hearing will be considered in determining whether a request is complete, and an appropriate level of leniency in providing for an opportunity to supplement the request with any missing information if OMHA identifies missing information that is required for a complete request.
After review and consideration of the comment received, for the reasons discussed above and in the proposed rule, we are finalizing §§ 405.1014(b) and 423.2014(c) as proposed without modification.
We proposed to incorporate portions of current § 405.1014(b) in proposed § 405.1014(c) and portions of current § 423.2014(c) in proposed § 423.2014(d) to address when and where to file a request for hearing or review. We proposed in §§ 405.1014(c) introductory language and (c)(1), and 423.2014(d) introductory language and (d)(1), to incorporate a request for a review of a QIC dismissal and a request for a review of an IRE dismissal, respectively, and provide that the current 60 calendar day period to file a request for hearing after a party receives a QIC or an IRE reconsideration also applies after a party receives a QIC or IRE dismissal, which is the time frame stated in §§ 405.1004 and 423.2004 to request a review of a QIC or IRE dismissal, respectively. We also proposed in § 405.1014(c)(1) to add an exception for requests filed in accordance with proposed § 405.1014(a)(3)(ii), because as discussed above, we proposed to require that requests for hearing on sample claims that are part of a statistical sample and/or extrapolation that the appellant also wishes to challenge would be filed together, which may be more than 60 calendar days after the appellant receives the first QIC reconsideration of one of the sample claims. In addition, we proposed to
Current § 423.1972(b) states that an enrollee must file a request for a hearing within 60 calendar days of the date of the notice of the IRE reconsideration determination. This requirement differs from § 423.2002(a)(1), which states that a request for hearing must be filed within 60 calendar days after receipt of the IRE's reconsideration (this is also the standard for filing Part A and Part B requests for hearing after receipt of QIC reconsiderations, at § 405.1002(a)(1)). Thus, we proposed to revise § 423.1972(b)(1) to state that a request for hearing must be filed within 60 calendar days after receipt of the IRE's reconsideration. We also proposed to add new § 423.1972(b)(2), to incorporate current § 423.2002(d), which provides the date of receipt of the reconsideration is presumed to be 5 calendar days after the date of the written reconsideration unless there is evidence to the contrary (this is also a presumption for receipt of QIC reconsiderations in Part A and Part B appeals, at § 405.1002). These changes would align proposed § 423.1972(b) with current § 423.2002, and remove potential enrollee confusion on when a request for an ALJ hearing must be filed.
Provided below is a summary of the specific comment received and our response to this comment:
After review and consideration of the comment received, for the reasons discussed above and in the proposed rule, we are finalizing § 423.1972(b) as proposed without modification. In addition, we are finalizing §§ 405.1014(c) and 423.2014(d) with the following modifications. As discussed in section II.B.3.b above, we are adding language to §§ 405.1014(c)(2) and 423.2014(d)(2)(i) to clarify that a request for an ALJ hearing that is timely filed with an office other than the office specified in the QIC's or IRE's reconsideration is not treated as untimely. We are also removing the term “entity office,” which was a drafting error, from proposed § 405.1014(c)(2) and adding “office” in its place.
We proposed to incorporate the portion of current § 405.1014(b)(2) that states that the appellant must also send a copy of the request for hearing to the other parties and failure to do so will toll the ALJ's 90 calendar day adjudication deadline until all parties to the QIC reconsideration receive notice of the requested ALJ hearing in proposed § 405.1014(d) with changes discussed below. Current § 405.1014(b)(2) has been another source of considerable confusion, and significant time and resources have been spent on this procedural matter by parties, OMHA, and the Council. Current § 405.1014(b)(2) requires an appellant to send a copy of the request for hearing to the other parties. Other parties consist of all of the parties specified in § 405.906(b) as parties to the reconsideration, including beneficiaries in overpayment cases that involve multiple beneficiaries who have
We also proposed in § 405.1014(d)(1) to address whether copies of materials that an appellant submits with a request for hearing or request for review of a QIC dismissal must be sent to other parties. Currently some ALJs consider the materials to be part of the request and require an appellant to send copies of all materials submitted with a request, while other ALJs do not consider the materials to be part of the request. We proposed in § 405.1014(d)(1) that if additional materials submitted with a request are necessary to provide the information required for a complete request in accordance with proposed § 405.1014(b), copies of the materials must be sent to the parties as well (subject to authorities that apply to disclosing the personal information of other parties). We also proposed that if additional evidence is submitted with the request for hearing, the appellant may send a copy of the evidence or briefly describe the evidence pertinent to the party and offer to provide copies of the evidence to the party at the party's request (subject to authorities that apply to disclosing the evidence). For example, if a complete request includes a position paper or brief that explains the reasons the appellant disagrees with the QIC's reconsideration, in accordance with proposed § 405.1014(a)(1)(v), a copy of the position paper or brief would be sent to the other parties, subject to any authorities that apply to disclosing the personal information of other parties. However, we stated that additional evidence such as medical records, is generally not required for a complete request, and therefore copies would not have to be sent, but could instead be summarized and provided to the other parties at their request, again subject to any authorities that apply to disclosing the personal information of other parties. We stated that this approach would balance the objectives of ensuring that parties to a claim and an appeal of that claim remain informed of the proceedings that are occurring on the claim, with the burdens on appellants to keep their co-parties so informed. We also noted that in sending a copy of the request for hearing and associated materials, appellants are free to include cover letters to explain the request, but we noted that such letters on their own do not satisfy the copy requirement in its current or proposed form. No corresponding changes were proposed in § 423.2014 because the enrollee is the only party to the appeal.
Current § 405.1014 does not contain standards for what constitutes evidence that a copy of the request for hearing or review, or copy of the evidence or a summary thereof, was sent to the other parties, which has led to confusion and inconsistent practices. Therefore, we proposed in § 405.1014(d)(2) to address this issue by establishing standards that an appellant would follow to satisfy the requirement. We proposed in § 405.1014(d)(2) that evidence that a copy of the request for hearing or review, or a copy of submitted evidence or a summary thereof, was sent includes: (1) Certifications that a copy of the request for hearing or request for review of a QIC dismissal is being sent to the other parties on the standard form for requesting a hearing or review of a QIC dismissal; (2) an indication, such as a copy or “cc” line on a request for hearing or review, that a copy of the request and any applicable attachments or enclosures are being sent to the other parties, including the name and address of the recipients; (3) an affidavit or certificate of service that identifies the name and address of the recipient and what was sent to the recipient; or (4) a mailing or shipping receipt that identifies the name and address of the recipient and what was sent to the recipient. We stated in the proposed rule that we believed these options would provide an appellant with flexibility to document the copy requirement was satisfied and bring consistency to the process.
Beyond stating that an adjudication time frame is tolled if a party does not satisfy the copy requirement, current § 405.1014 does not address the consequence of not satisfying the requirement, and adjudicators are faced with an appeal being indefinitely tolled because an appellant refuses to comply with the requirement. OMHA ALJs have addressed this issue by providing appellants with an opportunity to send the required copy of the request for hearing, and by informing the appellant that if the copy is not sent, its request will be dismissed. This allows OMHA ALJs to remove requests that do not satisfy the requirement from their active dockets so time and resources can be focused on appeals of those who comply with the rules. We proposed in § 405.1014(d)(3) that, if the appellant fails to send a copy of the request for hearing or request for review of a QIC dismissal, any additional materials, or a copy of the submitted evidence or a summary thereof, the appellant would be provided with an opportunity to cure the defects by sending the request, materials, and/or evidence or summary thereof described in proposed subsection (d)(1). Further, we proposed in § 405.1014(d)(3) that if an adjudication time frame applies, it does not begin until evidence that the request, materials, and/or evidence or summary thereof were sent is received. We also proposed in § 405.1014(d)(3) that if an appellant does not provide evidence within the time frame provided to demonstrate that the request, materials, and/or evidence or summary thereof were sent to other parties, the appellant's request for hearing or review would be dismissed.
Provided below are summaries of the specific comments received and responses to these comments:
We further note that § 405.1014(d)(1) as finalized actually reduces the number of recipients to whom an appellant is required to send a copy of the request and other materials. Instead of all of the parties to the reconsideration, which potentially includes beneficiaries who are not liable in overpayment cases that involve multiple beneficiaries, and therefore did not receive the notice of reconsideration in accordance with § 405.976(a)(2), § 405.1014(d)(1) as finalized only requires an appellant to send a copy to those parties who received a copy of the QIC's reconsideration or dismissal. This change will reduce the time and expense for an appellant to produce and send the required copies, and will reduce the amount of paperwork sent to beneficiaries who are otherwise uninvolved in the appeal.
With respect to including the full names and mailing addresses of the parties in a QIC reconsideration or dismissal, we thank the commenter for its suggestion and will share this recommendation with the QICs. However, at this time we do not believe that it would be appropriate to add the parties' contact information as a content requirement for QIC reconsiderations
After review and consideration of the comments received, for the reasons discussed above and in the proposed rule, we are finalizing our proposals to revise § 405.1014(d) with modification. We are amending § 405.1014(d)(3) to state that unrepresented beneficiaries are exempt from the consequences of failing to send a copy of the request for hearing, any additional materials, and/or a copy of submitted evidence or summary thereof, as described in § 405.1014(d)(1), to the other parties.
We proposed that the provisions of current §§ 405.1014(c) and 423.2014(d) for extensions of time to file a request for hearing would be incorporated in proposed §§ 405.1014(e) and 423.2014(e) with changes, and would extend to requests for reviews of QIC and IRE dismissals. On occasion, OMHA is asked whether a request for an extension should be filed without a request for hearing, for a determination on the request for extension before the request for hearing is filed. We stated that in those instances, we ask the filer to file both the request for hearing and request for extension at the same time because an independent adjudication of the extension request would be inefficient and any adjudication time frame begins on the date that the ALJ grants the extension request, in accordance with current §§ 405.1014(c)(4) and 423.2014(d)(5). We proposed in §§ 405.1014(e)(2) and 423.2014(e)(3) to require a request for an extension be filed with the request for hearing or request for review of a QIC or IRE dismissal, with the office specified in the notice of reconsideration or dismissal. We stated that the revisions we proposed in §§ 405.1014(e)(2) and 423.2014(e)(3) would also align the provisions with proposed §§ 405.1014(c) and 423.2014(d) by specifying that a request for an extension must be filed with the “office,” rather than the “entity,” specified in the notice of reconsideration. We proposed in §§ 405.1014(e)(3) and 423.2014(e)(4) that an ALJ or attorney adjudicator may find good cause to extend the deadline to file a request for an ALJ hearing or a request for a review of a QIC or IRE dismissal, or there is no good cause for missing the deadline to file a request for a review of a QIC or IRE dismissal, but only an ALJ may find there is no good cause for missing the deadline to file a request for an ALJ hearing. As we stated in the proposed rule, because only an ALJ may dismiss a request for an ALJ hearing for an untimely filing in accordance with proposed §§ 405.1052 and 423.2052, an attorney adjudicator could not make a determination on a request for an extension that would result in a dismissal of a request for hearing. We also proposed to incorporate current §§ 405.1014(c)(4) and 423.2014(d)(5) into proposed §§ 405.1014(e)(4) and 423.2014(e)(5), but indicate that the adjudication time frame begins on the date the ALJ or attorney adjudicator grants the request to extend the filing deadline only if there is an applicable adjudication period. Finally, we proposed in §§ 405.1014(e)(5) and 423.2014(e)(6) to add a new provision to provide finality for the appellant with regard to a determination to grant an extension of the filing deadline. We proposed that if an ALJ or attorney adjudicator were to make a determination to grant the extension, the determination is not subject to further review. However, we did not propose to preclude review of a determination to deny an extension because such a denial would result in a dismissal for an untimely filing, and the dismissal and determination on the request for an extension would be subject to review by the Council.
We received no comments on these proposals, other than comments discussed in section II.A.2 above related to our general proposals to provide authority for attorney adjudicators to issue certain decisions, dismissals and remands, and to revise the rules so that decisions and dismissals issued by attorney adjudicators may be reopened and/or appealed in the same manner as equivalent decisions and dismissals issued by ALJs. Accordingly, for the reasons discussed above and in the proposed rule, we are finalizing our proposals, as discussed above, without modification to revise §§ 405.1014(e) and 423.2014(e).
As discussed below, we proposed changes to § 405.1016, which addresses the adjudication time frames for requests for hearing filed after a QIC has issued its reconsideration, in accordance with section 1869(d)(1)(A) of the Act, and escalations of requests for a QIC reconsideration when the QIC does not issue its reconsideration within its adjudication time frame, which is permitted by section 1869(c)(3)(C)(ii) of the Act. 81 FR 43790, 43820-43821 We proposed to revise the title of § 405.1016 from “Time frames for deciding an appeal before an ALJ” to “Time frames for deciding an appeal of a QIC reconsideration or escalated request for a QIC reconsideration” because the section specifically applies to appeals of QIC reconsiderations and escalated requests for QIC reconsiderations (as specified in current and proposed § 405.1016(a) and (c)). This revision would also allow for application of this section to requests for hearing adjudicated by attorney adjudicators, as proposed in section II.B of the proposed rule (and discussed in section II.A.2 above). We also proposed to replace each instance of the term “the ALJ” with “the ALJ or attorney adjudicator” throughout proposed § 405.1016 to assist appellants in understanding that an adjudication time frame, and the option to escalate, also would apply to a request for an ALJ hearing following a QIC reconsideration when the request has been assigned to an attorney adjudicator, as proposed in section II.B of the proposed rule (and discussed in section II.A.2 above). We did not propose to change the reference to “a request for an ALJ hearing” because, as explained in section II.B of the proposed rule and II.A.2 above, even if an appellant waives its right to hearing, the case would remain subject to a potential oral hearing before an ALJ, and we believe the request is therefore properly characterized as a request for an ALJ hearing.
We proposed to add titles to proposed § 405.1016(a) to indicate that this paragraph discusses the adjudication period for appeals of QIC reconsiderations, and proposed § 405.1016(c) to indicate that this
We proposed to add a title to proposed § 405.1016(b) to indicate that the paragraph discusses when an adjudication period begins. We also proposed to re-designate current § 405.1016(b), which explains that the adjudication period for an appeal of a QIC reconsideration begins on the date that a timely filed request for hearing is received unless otherwise specified in the subpart, as § 405.1016(b)(1). We proposed in § 405.1016(b)(2) that if the Council remands a case and the case was subject to an adjudication time frame under paragraph (a) or (c), the remanded appeal would be subject to the adjudication time frame of § 405.1016(a) beginning on the date that OMHA receives the Council remand. Currently the regulations do not address whether an adjudication time frame applies to appeals that are remanded from the Council, and whether escalation is an option for these appeals. To provide appellants with an adjudication time frame for remanded appeals that were subject to an adjudication time frame when they were originally appealed to OMHA, we proposed in § 405.1016(b)(2) to apply the adjudication time frame under § 405.1016(a) to a remanded appeal that was subject to an adjudication time frame under paragraph (a) or (c). For example, if an ALJ decision reviewed by the Council involved a QIC reconsideration and was remanded by the Council, a 90 calendar day time frame would apply from the date that OMHA received the remand order. If the adjudication time frame is not met under proposed § 405.1016(b)(2), the appeal would be subject to escalation, in accordance with proposed § 405.1016(e).
In addition, we proposed in § 405.1016(a) and (b) to align the paragraphs with proposed § 405.1014(c) by specifying that a request for hearing is received by the “office,” rather than the “entity,” specified in the QIC's notice of reconsideration.
We proposed to add a title to proposed § 405.1016(d) to indicate that the paragraph discusses waivers and extensions of the adjudication period. We proposed in § 405.1016(d)(1) to incorporate the adjudication period waiver provision in current § 405.1036(d), which states that, at any time during the hearing process, the appellant may waive the adjudication deadline specified in § 405.1016 for issuing a hearing decision, and that the waiver may be for a specific period of time agreed upon by the ALJ and the appellant. We proposed to move the provision because, as we stated in the proposed rule, we believe it is more appropriately addressed in § 405.1016, as it is directly related to the adjudication period. We also proposed in § 405.1016(d) to revise the language in current § 405.1036(d) to reference an attorney adjudicator consistent with our proposals in section II.B of the proposed rule and as discussed in section II.A.2 above; to reference the “adjudication” process rather than the “hearing process” to account for appeals that may not involve a hearing; to consistently reference an adjudication “period” for internal consistency; and to replace the reference to § 405.1016 with internal paragraph references.
Current § 405.1016 does not address delays that result from stays ordered by U.S. Courts. In addition, we have had instances in which an appellant requests a stay of action on his or her appeals while related matters are addressed by another court or tribunal, or by investigators. To address these circumstances, we proposed in § 405.1016(d)(2) that the adjudication periods specified in paragraphs (a) and (c) are extended as otherwise specified in subpart I, and for the duration of any stay of action on adjudicating the claims or matters at issue ordered by a court or tribunal of competent jurisdiction, or the duration of any stay of proceedings granted by an ALJ or attorney adjudicator on the motion of the appellant, provided no other party also filed a request for hearing on the same claim at issue.
Provided below are summaries of the specific comments received and responses to these comments:
In contrast to the time limit for filing a request for hearing, § 405.1016(a) and (c) set forth time frames to obtain a decision, dismissal, or remand, which, consistent with section 1869(d)(3)(A) of the Act, if not met results in the appellant having the option to escalate the appeal to the Council. Whereas the consequence of not meeting the time limit for filing a request for hearing is that an adjudicator is precluded from reviewing the decision being appealed, the consequence of exceeding the adjudication time frames is the appellant then has the option to escalate the appeal to the next level. If the appellant at the hearing level chooses not to escalate his or her appeal to the Council, the appeal remains pending with OMHA in accordance with § 405.1016(e) as finalized, which replaces current § 405.1104(c) explaining the same.
After review and consideration of the comments received, for the reasons discussed above and in the proposed rule, we are finalizing these changes to
Section 405.1104 addresses how to request escalation from an ALJ to the Council, when an ALJ has not issued a decision, dismissal or remand on a QIC reconsideration within an applicable adjudication time frame, in accordance with section 1869(d)(3)(A) of the Act in paragraph (a); the procedures for escalating an appeal in paragraph (b); and the status of an appeal for which the adjudication time frame has expired but the appellant has not requested escalation in paragraph (c). We proposed to remove and reserve § 405.1104 and incorporate the current § 405.1104 providing for escalating a request for an ALJ hearing to the Council into proposed § 405.1016(e) and (f) with revisions, as its current placement in the Council portion of part 405, subpart I has caused confusion. We also proposed to insert “or attorney adjudicator” after “ALJ” in proposed § 405.1016(e) and (f) to assist appellants in understanding that the effect of exceeding the adjudication period and the option to escalate would apply to a request for an ALJ hearing following a QIC reconsideration when the request has been assigned to an attorney adjudicator, as discussed in section II.B of the proposed rule and II.A.2 above.
Section 405.1104(c) is titled “No escalation” and states that if the ALJ's adjudication period set forth in § 405.1016 expires, the case remains pending with the ALJ until a decision, dismissal order, or remand order is issued or the appellant requests escalation to the Council. We proposed in § 405.1016(e) to incorporate § 405.1104(c) with changes. We proposed to revise the paragraph title for proposed § 405.1016(e) to indicate that the paragraph discusses the effect of exceeding the adjudication period. Proposed § 405.1016(e) would provide that if an ALJ or an attorney adjudicator assigned to a request for hearing (as proposed in section II.B of the proposed rule and discussed in section II.A.2 of this final rule above) does not issue a decision, dismissal order, or remand to the QIC within an adjudication period specified in the section, the party that filed the request for hearing may escalate the appeal when the adjudication period expires. However, if the adjudication period expires and the party that filed the request for hearing does not exercise the option to escalate the appeal, the appeal remains pending with OMHA for a decision, dismissal order, or remand. We proposed to indicate that the appeal remains pending with OMHA to be inclusive of situations in which the appeal is assigned to an ALJ or attorney adjudicator, or not yet assigned.
Section 405.1104(a) describes how to request an escalation and states that an appellant who files a timely request for hearing before an ALJ and whose appeal continues to be pending before the ALJ at the end of the applicable ALJ adjudication period may request Council review if the appellant files a written request with the ALJ to escalate the appeal to the Council after the adjudication period has expired, and the ALJ does not issue a decision, dismissal order, or remand order within the later of 5 calendar days of receiving the request for escalation or 5 calendar days from the end of the applicable adjudication period set forth in § 405.1016. We proposed in § 405.1016(f)(1) to remove the requirement to request Council review in the course of requesting an escalation and to describe when and how to request escalation. Specifically, we proposed to revise the current procedures at § 405.1104(a) and (a)(1), to provide that an appellant who files a timely request for a hearing with OMHA and whose appeal continues to be pending at the end of an applicable adjudication period may exercise the option to escalate the appeal to the Council by filing a written request with OMHA to escalate the appeal to the Council, which would simplify the process for appellants and adjudicators by only requiring appellants to file a single request for escalation with OMHA. We proposed to replace the reference to an appeal that “continues to be pending before the ALJ” in § 405.1104(a) with an appeal that “continues to be pending with OMHA” in proposed § 405.1016(f)(1) to be inclusive of situations in which the appeal is assigned to an ALJ or attorney adjudicator, or not yet assigned. We also proposed that a written request to escalate an appeal to the Council would be filed with OMHA to allow OMHA to provide a central filing option for escalation requests. Section 405.1106(b) requires that the appellant send a copy of the escalation request to the other parties and failing to do so tolls the Council's adjudication deadline set forth in § 405.1100 until the other parties to the hearing have received notice. As discussed in section III.A.5.c of the proposed rule and II.B.5.c of this final rule below, we proposed to revise § 405.1106(b) to require that the request for escalation be sent to other parties who were sent a copy of the QIC reconsideration. Therefore, we also proposed at § 405.1016(f)(1) that the appellant would send a copy of the escalation request to the other parties who were sent a copy of the QIC reconsideration so appellants would be aware of the requirement and which parties must be sent a copy of the escalation request.
Section 405.1104(b) describes the escalation process and states if the ALJ is not able to issue a decision, dismissal order, or remand order within the time period set for in paragraph (a)(2) of the section (later of 5 calendar days of receiving the request for escalation or 5 calendar days from the end of the applicable adjudication period set forth in § 405.1016), he or she sends notice to the appellant acknowledging receipt of the request for escalation and confirming that the ALJ is not able to issue a decision, dismissal order, or remand order within the statutory time frame. Section 405.1104(b)(3) sates that if the ALJ does not act on a request for escalation within the time period set forth in paragraph (a)(2) of the section or does not send the required notice to the appellant, the QIC decision becomes the decision that is subject to Council review consistent with § 405.1102(a). We stated in the proposed rule that this process has caused confusion for both appellants and adjudicators because an initial escalation request must be filed with the ALJ, and if the ALJ is unable to issue a decision, dismissal or remand within 5 calendar days of receiving the escalation request or within 5 calendar days from the end of the applicable adjudication period, the appellant must file a request with the Council to move the appeal to the Council level. We also stated that some appellants neglect to take this second step of filing an escalation request with the Council. This leaves it unclear to the ALJ and support staff whether to continue adjudicating the appeal after issuing a notice that the ALJ is unable to issue a decision, dismissal or remand within the later of 5 calendar days of receiving the escalation request or 5 calendar days from the end of the applicable adjudication period. We proposed in § 405.1016(f)(2) to revise the escalation process. Specifically, we proposed that if an escalation request meets the requirements of proposed § 405.1016(f)(1), and an ALJ or attorney adjudicator is not able to issue a decision, dismissal order, or remand within the later of 5 calendar days of receiving the request for escalation or 5
Currently, invalid escalation requests are not addressed in the regulations. We proposed in § 405.1016(f)(3) to address invalid escalation requests. We proposed that if an ALJ or attorney adjudicator determines an escalation request does not meet the requirements of proposed § 405.1016(f)(1), OMHA would send a notice to the appellant explaining why the request is invalid within 5 calendar days of receiving the request for escalation. For example, we stated in the proposed rule that an escalation request would be deemed invalid if escalation is not available for the appeal, such as appeals of SSA reconsiderations; the escalation request is premature because the adjudication period has not expired; or the party that filed the escalation request did not file the request for hearing. We stated in the proposed rule that if an ALJ or attorney adjudicator were to determine the request for escalation was invalid for a reason that could be corrected (for example, if the request was premature), the appellant could file a new escalation request when the adjudication period expires.
We received no comments on our proposals to revise and incorporate the provisions of § 405.1104 into § 405.1016(e) and (f), other than: (1) Comments discussed in section II.A.2 above related to our general proposals to provide authority for attorney adjudicators to issue certain decisions, dismissals and remands, and to revise the rules so that decisions and dismissals issued by attorney adjudicators may be reopened and/or appealed in the same manner as equivalent decisions and dismissals issued by ALJs; and (2) comments discussed in section II.A.4 above related to our general proposal to reference OMHA or an OMHA office, in place of current references to an unspecified entity, ALJs, and ALJ hearing offices, when a reference to OMHA or an OMHA office provides a clearer explanation of a topic. Accordingly, for the reasons discussed above and in the proposed rule, we are finalizing the proposals without modification.
As discussed below, we proposed changes to § 423.2016, which addresses the adjudication time frames for requests for hearing filed after an IRE has issued its reconsideration. 81 FR 43790, 43823. The title of current § 423.2016 states, “Timeframes for deciding an Appeal before an ALJ.” We proposed to revise the title of § 423.2016 to read “Time frames for deciding an appeal of an IRE reconsideration” in order to state that the section addresses adjudication time frames related to appeals of IRE reconsiderations and to accommodate the application of this section to attorney adjudicators, as proposed in section II.B of the proposed rule (and discussed in section II.A.2 above), and as discussed earlier. We also proposed to insert “or attorney adjudicator” after “ALJ” throughout proposed § 423.2016 so that an adjudication time frame would apply to a request for an ALJ hearing following an IRE reconsideration when the request has been assigned to an attorney adjudicator, as discussed in section II.B of the proposed rule and II.A.2 above.
Current § 423.2016(a) and (b) explain the adjudication time frames for standard and expedited appeals of IRE reconsiderations, respectively. However, the current paragraph titles refer to hearings and expedited hearings. We proposed at § 423.2016(a) and (b) to retitle the paragraphs to refer to standard appeals and expedited appeals because the time frames apply to issuing a decision, dismissal, or remand, and are not limited to appeals in which a hearing is conducted. We proposed at § 423.2016(a) and (b) to remove “must” in providing when an ALJ or attorney adjudicator issues a decision, dismissal order, or remand to the IRE, as appropriate, after the request for hearing is received by the office specified in the IRE's notice of reconsideration because there may be instances in which a decision, dismissal, or remand cannot be issued within the adjudication time frame, though we stated that we expect those instances to be rare because beneficiary and enrollee appeals are generally prioritized by OMHA. In addition, we proposed in § 423.2016(a) and (b) to replace references to sending a request to the “entity” specified in the IRE's reconsideration, with the “office” specified in the IRE's reconsideration notice, to minimize confusion and delays in filing requests with OMHA. Similar to proposed § 405.1016(b)(2), we proposed at § 423.2016(a)(3) and (b)(6) to adopt adjudication time frames for appeals that are remanded by the Council. Specifically, we proposed in § 423.2016(a)(3) that if the Council remands a case and the case was subject to an adjudication time frame, the remanded appeal would be subject to the same adjudication time frame beginning on the date that OMHA receives the Council remand to provide enrollees with an adjudication time frame for remanded appeals. In § 423.2016(b)(6), we proposed to require that if the standards for an expedited appeal continue to be met after the appeal is remanded from the Council, the 10-day expedited time frame would apply to an appeal remanded by the Council. If the standards for an expedited appeal are no longer met, the adjudication time frame for standard appeals would apply because the criteria for an expedited hearing are no longer present. Finally, we proposed at § 423.2016(b) to revise the expedited appeal request process to permit an ALJ or attorney adjudicator to review a request for an expedited hearing, but not require the same ALJ or attorney adjudicator to adjudicate the expedited appeal, to provide OMHA with greater flexibility to review and assign requests for expedited hearings, and help ensure the 10-day adjudication process is completed as quickly as the enrollee's health requires. For example, if an attorney adjudicator were to review a request for an expedited hearing and determine that the standards for an expedited hearing were met, but did not believe a decision could be issued without a hearing, the attorney adjudicator could provide the enrollee with notice that the appeal would be expedited and transfer the appeal to an ALJ for an expedited hearing and decision.
As described in section III.A.3.q of the proposed rule and II.B.3.q below, we proposed to move the provision for
We proposed that the provisions of proposed § 405.1016(d) also be adopted in proposed § 423.2016(c) for adjudication period waivers and stays of the proceedings ordered by a court or granted by an ALJ or attorney adjudicator on motion by an enrollee.
Provided below are summaries of the specific comments received and responses to these comments:
We also disagree that the proposal is unnecessary. As we explained in the proposed rule, there may be times in which it is not possible to issue a decision, dismissal, or remand within the applicable adjudication time frame. 81 FR 43790, 43823. Removing “must” from § 423.2016(a) and (b) more accurately reflects that the time frames in those sections will not always be met.
After review and consideration of the comments received, for the reasons discussed above and in the proposed rule, we are finalizing these changes to § 423.2016 as proposed without modification.
As described below, we proposed a number of changes to current §§ 405.1018 and 423.2018, which address submitting evidence before an ALJ hearing is conducted. 81 FR 43790, 43823-43824. We proposed to retitle the sections from “Submitting evidence before the ALJ hearing” to “Submitting evidence” because evidence may be submitted and considered in appeals for which no hearing is conducted by an ALJ, and we believe an attorney adjudicator should be able to consider submitted evidence in deciding appeals as proposed in section II.B of the proposed rule (and discussed in section II.A.2 above). For the same reason, we proposed in § 423.2018 to replace the references to “hearings” in the heading to paragraph (a) and in the introductory text to paragraphs (b) and (c), with “appeals.” We also proposed to add headings to paragraphs that do not currently have headings, for clarity of the matters addressed in the paragraphs.
Current § 405.1018(a) states that, except as provided in this section, parties must submit all written evidence they wish to have considered at the hearing with the request for hearing (or within 10 calendar days of receiving the notice of hearing). We proposed in § 405.1018(a) to provide for the submission of other evidence, in addition to written evidence, that the parties wish to have considered. Other evidence could be images or data submitted on electronic media. We proposed to also adopt this revision in § 405.1018(b) and § 423.2018(a), (b), and (c). We also proposed in § 405.1018(a) to remove “at the hearing” so that parties would submit all written or other evidence they wish to have considered, and consideration of the evidence would not be limited to the hearing. We proposed a corresponding change to § 423.2018(a).
Current § 405.1018(a) states that evidence must be submitted with the request for hearing, or within 10 calendar days of receiving the notice of hearing. This provision has caused confusion as to when evidence is required to have been submitted because current § 405.1014(a)(7) allows an appellant to state in the request for hearing that additional evidence will be submitted and the date it will be submitted. To reconcile the provisions, we proposed in § 405.1018(a) to provide that parties must submit all written or other evidence they wish to have considered with the request for hearing, by the date specified in the request for hearing in accordance with proposed § 405.1014(a)(2), or if a hearing is scheduled, within 10 calendar days of receiving the notice of hearing. We proposed to also adopt these revisions in § 423.2018(b) and (c).
Current § 405.1018(b) addresses how the submission of evidence impacts the adjudication period, and provides that if evidence is submitted later than 10 calendar days after receiving the notice of hearing, the period between when the evidence “was required to have been submitted” and the time it is received does not count towards an adjudication period. To simplify the provision, we proposed at § 405.1018(b) that if evidence is submitted later than 10 calendar days after receiving the notice of hearing, any applicable adjudication period is extended by the number of calendar days in the period between 10 calendar days after receipt of the notice of hearing and the day the evidence is received. We also proposed to adopt this provision in § 423.2018(b)(2) and (c)(2), except that in (c)(2), the adjudication time frame is affected if the evidence is submitted later than 2 calendar days after receipt of the notice of expedited hearing because 2 calendar days is the equivalent time frame to submit evidence for expedited appeals before the adjudication period is affected under current § 423.2018.
Current § 405.1018(c) addresses new evidence, and is part of the implementation of section 1869(b)(3) of the Act, which precludes a provider or supplier from introducing evidence after the QIC reconsideration unless there is good cause that prevented the evidence from being introduced at or before the QIC's reconsideration. These provisions, which provide for the early submission of evidence, help adjudicators to obtain evidence necessary to reach the correct decision as early in the appeals process as possible. We proposed to incorporate current § 405.1018(c), which requires a provider, supplier, or beneficiary represented by a provider or supplier that wishes to introduce new evidence to submit a statement explaining why the evidence was not previously submitted to the QIC, or a prior decision-maker, in proposed § 405.1018(c)(1). However, current § 405.1018 does not address the consequences of not submitting the statement. The statute sets a bar to introducing new evidence, and the submitting party must establish good cause by explaining why the evidence was not previously submitted to the QIC, or a prior decision-maker. However, when a provider or supplier, or beneficiary represented by a provider or supplier, fails to include the required statement, OMHA ALJs and staff spend time seeking out the explanation and following up with parties to fulfill their obligation. Thus, we proposed to revise § 405.1018(c)(2) to state that if the provider or supplier, or beneficiary represented by a provider or supplier fails to include the statement explaining why the evidence was not previously submitted, the evidence will not be considered. Because only the enrollee is a party to a Part D appeal, we did not propose a corresponding revision to § 423.2018.
Provided below are summaries of the specific comments received and responses to these comments:
Under proposed § 405.1018(a), we proposed to add an explicit reference to the § 405.1014(a)(7) provision (re-designated as proposed § 405.1014(a)(2)) to more fully specify in proposed § 405.1018(a) when evidence may be submitted. Under proposed § 405.1018(a), evidence can be submitted after a request for hearing is submitted and, therefore, an appellant would not be precluded from submitting the evidence at a later time. For example, an appellant could indicate in the request for hearing that it has additional evidence to submit and will submit it when the appeal is assigned to an adjudicator. However, there may be times when the appellant wishes to submit new evidence with the request for hearing, such as when the appellant waives his or her right to appear at a hearing before an ALJ and requests that a decision be made on the record, or the appellant believes the evidence addresses the issues identified in the reconsideration and including the evidence may increase the likelihood that a decision that is fully favorable could be issued based on the record alone in accordance with proposed § 405.1038(a). The current appeal instructions do not preclude an appellant from submitting evidence with the request for hearing, but rather request that appellants consider submitting it at a later time. Therefore, we believe that by allowing for the submission of evidence with the request for hearing or after the request is submitted, by the date specified in the request for hearing in accordance with § 405.1014(a)(2) or, if a hearing is scheduled, within 10 calendar days of receiving the notice of hearing, proposed § 405.1018(a) is not incompatible with appeal instructions currently sent by QICs. However, we will review the appeal instructions being issued by QICs to determine if clarification may be appropriate to reduce potential confusion.
After review and consideration of the comments received, for the reasons discussed above and in the proposed rule, we are finalizing the changes to §§ 405.1018 and 423.2018 as proposed with the following modifications. We are revising § 405.1018(d) to provide in paragraph (d)(1) that the requirements in paragraphs (a) and (b) do not apply to oral testimony given at a hearing or to evidence submitted by unrepresented beneficiaries, and in (d)(2) that the requirement in paragraph (c) to support new evidence with a statement of good cause does not apply to oral testimony given at a hearing or to evidence submitted by an unrepresented beneficiary, CMS or any of its contractors, a Medicaid State agency, an applicable plan, or a beneficiary represented by someone other than a provider or supplier. We are also correcting a drafting error and adding a missing comma to § 423.2018(b)(1) and (c)(1) for consistency with § 405.1018(a) and to clarify that there are three time frames when a represented enrollee may submit written or other evidence he or she wishes to have considered with the request for hearing: (1) With the request for hearing; (2) by the date specified in the request for hearing in accordance with § 423.2014(a)(2); or (3) if a hearing is scheduled, within 10 calendar days of receiving the notice of hearing.
As described below, we proposed a number of changes to provisions concerning the time and place for a hearing before an ALJ in §§ 405.1020 and 423.2020. 81 FR 43790, 43824-43827. As the ALJ hearing function transitioned from SSA, where hearings could be held at over 140 hearing sites nation-wide, to OMHA with four field offices, OMHA became one of the first agencies to use video-teleconferencing (VTC) as the default mode of administrative hearings. The effective use of VTC mitigated OMHA's reduced geographic presence, and allowed OMHA to operate more efficiently and at lower cost to the American taxpayers. However, the preference of most appellants quickly turned to hearings conducted by telephone. We stated in the proposed rule that, in FY 2015, over 98% of hearings before OMHA ALJs were conducted by telephone. Telephone hearings provide parties and their representatives and witnesses with the opportunity to participate in the hearing process with minimal disruption to their day, and require less administrative burden at even lower cost to the American taxpayers than hearings conducted by VTC. OMHA ALJs also prefer telephone hearings in most instances, because they allow more hearings to be conducted without compromising the integrity of the hearing. However, even if a telephone hearing is being conducted, when the ALJ conducting the hearing believes visual interaction is necessary for a hearing, he or she may conduct a VTC hearing, and when special circumstances are presented, ALJs may conduct in-person hearings.
Despite the shift in preferences for most appellants to telephone hearings, current § 405.1020 still makes VTC the default mode of hearing, with the option to offer a telephone hearing to appellants. In fact, some appellants have required the more expensive VTC hearing even when their representative is presenting only argument and no testimony is being offered. We stated in the proposed rule that we believe this is inefficient and results in wasted time and resources that could be invested in adjudicating additional appeals, and unnecessarily increases the administrative burdens and costs on the government for conducting a hearing with little to no discernable benefit to the parties in adjudicating denials of items or services that have already been furnished. Based on these considerations, we proposed that a telephone hearing be the default method, unless the appellant is an unrepresented beneficiary. We stated in the proposed rule that we believed that this proposal balances the costs and administrative burdens with the interests of the parties, recognizing that unrepresented beneficiaries may have an increased need and desire to visually interact with the ALJ.
We proposed in § 405.1020(b) to provide two standards for determining how appearances are made, depending on whether appearances are by unrepresented beneficiaries or by individuals other than unrepresented beneficiaries. We proposed to incorporate the provisions of current § 405.1020(b) into proposed § 405.1020(b)(1), and revise them to specify that they are applicable to an appearance by an unrepresented beneficiary who files a request for hearing. We proposed in subsection (b)(1) that the ALJ would direct that the appearance of an unrepresented beneficiary who filed a request for hearing be conducted by VTC if the ALJ finds that VTC technology is available to conduct the appearance, unless the ALJ finds good cause for an in-person appearance. As in the current rule, we also proposed in § 405.1020(b)(1) to allow the ALJ to offer to conduct a telephone hearing if the request for hearing or administrative record suggests that a telephone hearing may be more convenient to the unrepresented beneficiary. The current standard for determining whether an in-person hearing should be conducted involves a finding that VTC technology is not available or special or extraordinary circumstances exist. Because, absent special or extraordinary circumstances, a hearing could still be conducted by telephone if VTC technology were unavailable, we proposed that the standard for an in-person hearing be revised to state that VTC or telephone technology is not available or special or extraordinary circumstances exist, and the determination would be characterized as finding good cause for an in-person hearing, to align with current § 405.1020(i)(5), which provides for granting a request for an in-person hearing on a finding of good cause. We also proposed in §§ 405.1020(b)(1) and 405.1020(i)(5) to replace the reference to obtaining the concurrence of the “Managing Field Office ALJ” with the “Chief ALJ or designee.” We stated in the proposed rule that the position of the Managing Field Office ALJ became what is now an Associate Chief ALJ, see
Section 405.1020(b)(2), as proposed, addresses appearances by an individual other than an unrepresented beneficiary who files a request for hearing. We proposed in § 405.1020(b)(2) that the ALJ would direct that those individuals appear by telephone, unless the ALJ finds good cause for an appearance by other means. Further, we proposed in § 405.1020(b)(2) that the ALJ may find good cause for an appearance by VTC if he or she determines that VTC is necessary to examine the facts or issues involved in the appeal. Also, we proposed that the ALJ, with the concurrence of the Chief ALJ or designee, may find good cause that an in-person hearing should be conducted if VTC and telephone technology are not available, or special or extraordinary circumstances exist. We proposed to adopt these revisions in § 423.2020(b)(2) for appearances by represented enrollees, which is more specific than proposed § 405.1020(b)(2) because only enrollees are parties to appeals under part 423, subpart U, and the provisions of subsection (b)(2) would apply only to appearances by represented enrollees.
Current § 405.1020(c)(1) states that the ALJ sends a notice of hearing. This has caused confusion as to whether the ALJ must personally sign the notice, or whether it can be sent at the direction of the ALJ. We believe that the notice may be sent at the direction of the ALJ, and requiring an ALJ signature adds an unnecessary step in the process of issuing the notice. Therefore, we proposed in § 405.1020(c)(1) that a notice of hearing be sent without further qualification, and to let other provisions indicate the direction that is necessary from the ALJ in order to send the notice, such as § 405.1022(c)(1), which provides that the ALJ sets the time and place of the hearing. We proposed to adopt these provisions in § 423.2020(a)(1).
Current § 405.1020(c)(1) also requires that the notice of hearing be sent to the parties who filed an appeal or participated in the reconsideration, any party who was found liable for the services at issue subsequent to the initial determination, and the QIC that issued the reconsideration. However, there are instances in which a party who does not meet the criteria may face liability because the ALJ may consider a new issue based on a review of the record. To address this, we proposed in § 405.1020(c)(1) to add that a party that may be found liable based on a review of the record must be sent a notice of hearing. In addition, current § 405.1020 does not address notices of hearing sent to CMS or a non-QIC contractor. We stated in the proposed rule that, currently, ALJs may also send a notice of hearing to CMS or a contractor when the ALJ believes their input as a participant or party may be beneficial. We proposed in § 405.1020(c)(1) that the notice of hearing also be sent to CMS or a contractor that the ALJ believes would be beneficial to the hearing. We did not propose any corresponding revisions to current § 423.2020(c)(1) because only enrollees are parties to appeals under part 423, subpart U.
OMHA ALJs have expressed concern that parties and representatives who appear at a hearing with multiple individuals and witnesses who were not previously identified, complicate and slow the hearing process. We stated that while a party or representative has considerable leeway in determining who will attend the hearing or be called as a witness, prior notice of those individuals is necessary for the ALJs to schedule adequate hearing time, manage their dockets, and conduct the hearing. To address these concerns, we proposed at § 405.1020(c)(2)(ii) to add a requirement to specify the individuals from the entity or organization who plan to attend the hearing if the party or representative is an entity or organization, and at subsection (c)(2)(iii) to add a requirement to list the witnesses who will be providing testimony at the hearing, in the response to the notice of hearing. We also proposed to consolidate the provisions in current § 405.1020(c)(2)(i) and (c)(2)(ii) in proposed § 405.1020(c)(2)(i) to simplify the provisions related to the current requirements for replying to the notice of hearing. Thus, subsection (c)(2)(i) would require all parties to the ALJ hearing to reply to the notice by acknowledging whether they plan to attend the hearing at the time and place proposed in the notice of hearing, or whether they object to the proposed time and/or place of the hearing. We proposed at § 423.2020(c)(2) to adopt corresponding revisions for an enrollee's reply to the notice of hearing.
We also proposed in § 405.1020(c)(2) to remove the provision for CMS or a contractor that wishes to participate in the hearing to reply to the notice of hearing in the same manner as a party because a non-party may not object to the proposed time and place of the hearing, or present witnesses. Instead, we proposed in § 405.1020(c)(3) to require CMS or a contractor that wishes to attend the hearing as a participant to reply to the notice of hearing by acknowledging whether it plans to attend the hearing at the time and place proposed in the notice of hearing, and specifying who from the entity plans to attend the hearing. We proposed at § 423.2020(c)(3) to adopt corresponding revisions for CMS's, the IRE's, or the Part D plan sponsor's reply to the notice of hearing when the entity requests to attend the hearing as a participant.
In discussing a party's right to waive a hearing, current § 405.1020(d) states that a party may waive the right to a hearing and request that the ALJ issue a decision based on the written evidence in the record. In light of proposed § 405.1038(b), which would allow attorney adjudicators to issue decisions in appeals that do not require hearings on the record without an ALJ conducting a hearing in certain situations, we proposed in § 405.1020(d) to state that a party also may waive the right to a hearing and request a decision based on the written evidence in the record in accordance with § 405.1038(b), but an ALJ may require the parties to attend a hearing if it is necessary to decide the case. We proposed at § 423.2020(d) to adopt corresponding revisions for an enrollee to waive his or her right to a hearing and request a decision based on the written evidence in the record in accordance with § 423.2038(b), but an ALJ could require the enrollee to attend a hearing if it is necessary to decide the case. We stated in the proposed rule that these references would direct readers to the section that provides the authority for a decision based on the written record, which would provide them with a complete explanation of when the authority may be used and notify them that an ALJ or attorney adjudicator may issue the decision.
In addressing the ALJ's authority to change the time or place of the hearing if the party has good cause to object, current § 405.1020(e) requires a party to make the request to change the time or place of the hearing in writing. However, we stated that on occasion, a party may need to request a change on the day prior to, or the day of, a hearing due to an emergency, such as a sudden illness or injury, or inability to get to a
In addition, current §§ 405.1020(e)(4) and 423.2020(e)(4), which explain the ALJ may change the time or place of the hearing if the party has good cause, contain a parenthetical that references the procedures that an ALJ follows when a party does not respond to a notice of hearing and fails to appear at the time and place of the hearing. The parenthetical does not appear to address or assist in understanding the circumstances covered by current §§ 405.1020(e)(4) and 423.2020(e)(4), and we, therefore, proposed to remove the parenthetical from the respective sections.
Current §§ 405.1020(g)(3) and 423.2020(g)(3) provide a list of examples of circumstances a party might give for requesting a change in the time or place of the hearing. We stated in the proposed rule that we have heard from ALJs and stakeholders that it would be helpful to also include the following two additional examples: (1) The party or representative has a prior commitment that cannot be changed without significant expense, in order to account for circumstances in which travel or other costly events may conflict with the time and place of a hearing, which the ALJ may determines warrants good cause for changing the time or place of the hearing; and (2) the party or representative asserts that he or she did not receive the notice of hearing and is unable to appear at the scheduled time and place, which the ALJ may determine warrants good cause for changing the time or place of the hearing. We proposed in §§ 405.1020(g)(3)(vii) and (viii), and 423.2020(g)(3)(vii) and (viii) to add these two examples to address these circumstances. We believe these additional examples will provide greater flexibility in the appeals process and better accommodate the needs of appellants.
We proposed in §§ 405.1020(h) and 423.2020(h) to revise the references to the adjudication “deadline” with references to the adjudication “period,” for consistency in terminology with the specified cross-references.
We proposed revisions to § 405.1020(i) to align the provision with proposed § 405.1020(b). We proposed in § 405.1020(i) that if an unrepresented beneficiary who filed the request for hearing objects to a VTC hearing or to the ALJ's offer to conduct a hearing by telephone, or if a party other than an unrepresented beneficiary who filed the request for hearing objects to a telephone or VTC hearing, the party must notify the ALJ at the earliest possible opportunity before the time set for the hearing and request a VTC or in-person hearing. The party would be required to state the reason for the objection and the time and/or place that he or she wants an in-person or VTC hearing to be held, and the request must be in writing. We proposed in § 405.1020(i)(4) to incorporate the current § 405.1020(i)(4) provision that requires the appeal to be adjudicated within the time frame specified in § 405.1016 if a request for an in-person or VTC hearing is granted unless the party waives the time frame in writing. However, we proposed at § 405.1020(i)(4) to revise the language to more accurately state that the ALJ issues a “decision, dismissal, or remand to the QIC,” rather than just a “decision,” within the adjudication time frame specified in § 405.1016. We proposed revisions to § 423.2020(i) to align the provision with proposed § 423.2020(b). We proposed in § 423.2020(i) that if an unrepresented enrollee who filed the request for hearing objects to a VTC hearing or to the ALJ's offer to conduct a hearing by telephone, or if a represented enrollee who filed the request for hearing objects to a telephone or VTC hearing, the enrollee or representative must notify the ALJ at the earliest possible opportunity before the time set for the hearing and request a VTC or in-person hearing. The enrollee would be required to state the reason for the objection and the time and/or place that he or she wants an in-person or VTC hearing to be held. We proposed in § 423.2020(i)(4) to incorporate the current § 423.2020(i)(4) provision with some modifications so that the appeal would be adjudicated within the time frame specified in § 423.2016 if a request for an in-person or VTC hearing is granted unless the party waives the time frame in writing. We proposed at § 423.2020(i)(4) to revise the language to more accurately state that the ALJ issues a “decision, dismissal, or remand to the IRE,” rather than just a “decision,” within the adjudication time frame specified in § 423.2016 and to include requests for VTC hearings as well as requests for in-person hearings. In addition, we proposed at §§ 405.1020(i)(5) and 423.2020(i)(5) to provide that upon a finding of good cause, a hearing would be rescheduled at a time and place when the party may appear in person or by VTC, to account for objections to VTC hearings as well as objections to telephone hearings or offers to conduct a hearing via telephone. We also proposed to replace “concurrence of the Managing Field Office ALJ” with “concurrence of the Chief ALJ or a designee” because the position of Managing Field Office ALJ was replaced by the position of Associate Chief ALJ (80 FR 2708) and providing a more general reference would provide greater flexibility in the future as position titles change.
Current §§ 405.1020 and 423.2020 do not address what occurs when the ALJ changes the time or place of the hearing. We proposed at § 405.1020(j) to add a provision titled “Amended notice of hearing” to clarify that, if the ALJ changes or will change the time and/or place of the hearing, an amended notice of hearing must be sent to all of the parties who were sent a copy of the notice of hearing and CMS or its contractors that elected to be a participant or party to the hearing, in accordance with the procedures of § 405.1022(a), which addresses issuing a notice of hearing. We proposed at § 423.2020(j) to add a provision to clarify that, if the ALJ changes or will change the time and/or place of the hearing, an amended notice of hearing must be sent to the enrollee and CMS, the IRE, and/or the Part D plan sponsor in accordance with the procedures of § 423.2022(a), which addresses issuing a notice of hearing. We stated that these revisions would help ensure that if changes are made to the time or place of the hearing, a new notice is issued or waivers are obtained in a consistent manner.
Provided below are summaries of the specific comments received and responses to these comments:
We received ten comments on the proposed changes to time and place for a hearing before an ALJ. We received five comments on the proposal to make telephone the default method for conducting hearings, except when the appellant is an unrepresented beneficiary, unless an ALJ finds good cause for conducting a hearing by VTC or an in-person hearing. The remaining
Under both the current regulations and our proposed changes, procedural safeguards are in place that meet the due process requirements for administrative hearings such as the right to proper notice that a hearing has been scheduled, the right of a party to appear before the ALJ to present evidence and to state his or her position, the right to have a representative present at the hearing, the right to present witnesses and testimony, the right to cross examine witnesses, the right to object to the issues in the notice and/or the hearing method, the right to request and receive a copy of all or part of the record from OMHA (including the hearing audio), and the right to appeal the ALJ's decision. Parties also have the same access to the audio hearing record when appearing by telephone as they would have if appearing by VTC or in-person. In addition, the proposal includes mechanisms in § 405.1020(b) that permit a VTC or in-person hearing if there is a finding of good cause in a given appeal. Given the procedural safeguards existing in the regulations, we do not believe changing the default method of conducting hearings to telephone hearings for appellants other than unrepresented beneficiaries would compromise an appellant's due process or right to a hearing.
However, while we do not believe that due process requires a hearing that includes a visual component as a matter of right in all cases, we acknowledge that those who are most unfamiliar with legal proceedings, specifically unrepresented beneficiaries, may benefit from the interaction with the ALJ and be more comfortable with a visual component. Thus, the proposal provides two standards for determining how hearings would be conducted, depending on whether appearances are by unrepresented beneficiaries or by individuals other than unrepresented beneficiaries. We have retained VTC as the default hearing method for unrepresented beneficiaries under § 405.1020(b)(1), unless the ALJ finds good cause for an in-person hearing (note that the ALJ also may offer a telephone hearing in certain circumstances). Under § 405.1020(b)(2) (as discussed below), in appearances by individuals other than unrepresented beneficiaries, telephone hearings are the default hearing method, though the parties may obtain a VTC or in-person hearing if the ALJ finds good cause.
As we stated in the proposed rule (81 FR 43824), in FY2015 alone, over 98% of hearings before OMHA ALJs were conducted by telephone, and in FY2016 over 99% of hearings before OMHA ALJs were conducted by telephone. Contrary to the commenter's assertion, we have learned over eleven years of operation that telephone hearings take less time and are less costly for parties, representatives, and witnesses because telephone hearings do not require travel time or travel expenses for parties to a VTC site. Telephone hearings also provide parties with the opportunity to participate in the hearing process with minimal disruption to the day. Further, telephone hearings take less time for OMHA to schedule and conduct. When a VTC hearing room is reserved or unavailable, scheduling of the hearing is delayed. Support staff must also remain present during the entire duration of a VTC hearing to assist the ALJ in case the equipment does not operate properly. We believe this is inefficient and can result in wasted staff time and resources that could be redirected to scheduling additional appeals.
Although we acknowledge the volume of VTC hearings in past years has not exceeded OMHA's operational budget, due in part to the fact that a majority of hearings were conducted by telephone, telephone hearings cost less to conduct, and would result in significant savings to the agency and ultimately to the taxpayers. We also believe the money budgeted to provide for the more expensive VTC hearings could instead be reallocated to hire additional support staff and resources to address the backlog. On balance, telephone hearings require less administrative burden to parties and OMHA, at a lower cost to taxpayers.
In addition, we do not believe that visual interaction is necessary to assure appellants that ALJs are fulfilling their duty to provide a fair hearing. OMHA ALJs have a responsibility to ensure both a fully examined and fairly administered hearing, and must fulfill their duties with fairness and impartiality in accordance with section 205(b) of the Act. As discussed above, we believe that all ALJ hearings currently conducted by OMHA fully protect appellants' rights to procedural due process, including the right to a fair hearing, and that the changes we are finalizing do not compromise those rights. Further, we do not agree that visual interaction is necessary to observe whether the ALJ is tired, disinterested, or talking to someone else in the room, because an appellant can readily observe how the ALJ is acting during a telephone hearing by noting the ALJ's tone of voice, pauses, and reaction to arguments or responses to questions. Moreover, we note the visual component of the hearing is not recorded or subject to review. However, parties have the same access to the audio hearing record when appearing by telephone as they would have if appearing by VTC or in person. The ALJ and his or her staff may also review the audio hearing record after the hearing is conducted, which becomes part of the administrative record for other reviewers. Based on the foregoing, we believe that telephone hearings provide sufficient assurances addressed by the commenters.
After review and consideration of the comments received, for the reasons discussed above and in the proposed rule, we are finalizing the changes to §§ 405.1020 and 423.2020 as proposed, with the following modifications. For the reasons discussed in section II.B.3.f.i above, we are revising § 405.1020(c)(1) to state that the notice of hearing is also sent to CMS or any contractor that has elected to participate in the proceedings in accordance with § 405.1010(b). In addition, in the proposed rule (81 FR 43790, 43825), we proposed to adopt in § 423.2020(b)(2) the same revisions as in § 405.1020(b)(2). Section 405.1020(b)(2)(ii)(A), as finalized in this rule, states “VTC and telephone technology are not available.” However, we inadvertently included in proposed § 423.2020(b)(2)(ii)(A) the following language: “video-teleconferencing or telephone technology is not available.” Consistent with our proposal to adopt the same revisions in § 423.2020(b)(2) as we adopt in § 405.1020(b)(2), we are revising § 423.2020(b)(2)(ii)(A) to state “video-teleconferencing and telephone technology are not available.”
As described below, we proposed a number of changes to §§ 405.1022, 405.1024, 423.2022, and 423.2024, concerning notice of a hearing before an ALJ and objections to the issues. 81 FR 43790, 43827-43828. Current § 405.1022(a) provides that a notice of hearing will be mailed or personally served to the parties and other potential participants, but a notice is not sent to a party who indicates in writing that it does not wish to receive the notice. Current § 423.2022(a) provides that a notice of hearing will be mailed or otherwise transmitted, or personally served, unless the enrollee or other potential participant indicates in writing that he or she does not wish to receive the notice. However, currently § 405.1022(a) is limiting because it does not contemplate transmitting the notice by means other than mail or personal service even though technologies continue to develop and notice could be provided by secure email or a secure portal. Also, notices must be sent in accordance with any OMHA procedures that apply, such as procedures to protect personally identifiable information. In addition, the exception in current § 405.1022(a) does not contemplate a scenario in which a potential participant indicates that it does not wish to receive the notice, as is provided for in current § 423.2022(a). We proposed in §§ 405.1022(a) and 423.2022(a) to address these issues and align the sections by providing that a notice of hearing would be mailed or otherwise transmitted in accordance with OMHA procedures, or personally served, except to a party or other potential participant who indicates in writing that he or she does not wish to receive the notice.
Current §§ 405.1022(a) and 423.2022(a) provide that a notice of hearing does not have to be sent to a party who indicates in writing that it does not wish to receive the notice and that the notice is mailed or served at least 20 calendar days (for Parts A and B and for non-expedited Part D hearings), or 3 calendar days (for expedited Part D hearings) before the hearing. The provisions do not address the situation where a party wishes to receive the notice, but agrees to the notice being mailed fewer than 20 calendar days (or 3 calendar days if expedited) before the hearing, which may be necessary to accommodate an appellant's request to conduct a hearing in fewer than 20 or 3 calendar days. We proposed to revise §§ 405.1022(a) and 423.2022(a) to address this situation by providing the notice is mailed, transmitted, or served at least 20 calendar days (or 3 calendar days if expedited) before the hearing unless the recipient agrees in writing to the notice being mailed, transmitted, or served fewer than 20 calendar days (or 3 calendar days if expedited) before the hearing. However, we note that like a recipient's waiver of receiving a notice of hearing, a recipient's waiver of the requirement to mail, transmit, or serve the notice at least 20 or 3 calendar days (as applicable) before the hearing would only be effective for the waiving recipient and does not affect the rights of other recipients.
Current § 405.1022(b)(1) requires a notice of hearing to contain a statement of the specific issues to be decided and inform the parties that they may designate a person to represent them during the proceedings. These statements of issues take time to develop, and current § 405.1032, which addresses the issues before an ALJ, provides that the issues before the ALJ are all the issues brought out in the initial determination, redetermination, or reconsideration that were not decided entirely in a party's favor. Current § 405.1032 also permits an ALJ to consider a new issue at the hearing, if notice of the new issue is provided to all parties before the start of the hearing. To streamline the notice of hearing,
Current § 405.1022(c)(1) provides that if the appellant, any other party to the reconsideration to whom the notice of hearing was sent, or their representative does not acknowledge receipt of the notice of hearing, the ALJ hearing office attempts to contact the party for an explanation. We proposed to replace “ALJ hearing office” with “OMHA” because OMHA is the responsible entity.
Current § 405.1022(c)(2) provides that if a party states that he or she did not receive the notice of hearing, an amended notice is sent to him or her. The reference to an amended notice has caused confusion, as the original notice does not need to be amended unless the hearing is rescheduled. We proposed in § 405.1022(c)(2) to remove the reference to an “amended” notice of hearing and provide that a copy of the notice of hearing is sent to the party. However, if a party cannot attend the hearing, we proposed in new § 405.1022(c)(3) that the party may request that the ALJ reschedule the hearing in accordance with proposed § 405.1020(e), which discusses a party's objection to the time and place of hearing. We proposed at § 423.2022(c) to adopt corresponding revisions for providing a copy of the notice of hearing if the enrollee did not acknowledge it and states that he or she did not receive it in part 423, subpart U proceedings.
Current § 405.1022(c)(2) provides that if a party did not receive the notice of hearing, a copy of the notice may be sent by certified mail or email, if available. Current § 423.2022(c)(2) provides an additional option to send the copy by fax. However, use of email to send documents that contain a beneficiary's or enrollee's personally identifiable information is not currently permitted by OMHA policy, and faxes must be sent in accordance with procedures to protect personally identifiable information. We proposed in §§ 405.1022(c)(2) and 423.2022(c)(2) to remove the references to using email and fax, and to add that a notice may be sent by certified mail or other means requested by the party and in accordance with OMHA procedures. This would provide the flexibility to develop alternate means of transmitting the request and allow OMHA to help ensure necessary protections are in place to comply with HHS information security policies. Finally, the parenthetical in current §§ 405.1022(c)(2) and 423.2022(c)(2) is not applicable. We believe it was attempting to cross-reference the provision related to requesting a rescheduled hearing. Therefore, we proposed in §§ 405.1022(c)(2) and 423.2022(c)(2) to remove the parenthetical. As discussed above, proposed §§ 405.1022(c)(3) and 423.2022(c)(3) would address the option for a party to request a rescheduled hearing and contain the correct cross-reference.
Current § 405.1024 sets forth the provision regarding objections by a party to the issues described in the notice of hearing. Current § 405.1024(b) requires a party to send a copy of its objection to the issues to all other parties to the appeal. We proposed to revise § 405.1024(b) to provide that the copy is only sent to the parties who were sent a copy of the notice of hearing, and CMS or a contractor that elected to be a party to the hearing, because we believe sending a copy of the objection to additional parties is unnecessary and causes confusion for parties who were not sent a copy of the notice of hearing. No corresponding change was proposed in § 423.2024 because only the enrollee is a party.
Current § 405.1024(c) states that an ALJ makes a decision on the objection to the issues either in writing or at the hearing. We proposed to revise § 405.1024(c) to add the option for an ALJ to make a decision on the objections at a prehearing conference, which is conducted to facilitate the hearing, as well as at the hearing. We believe this added flexibility would allow ALJs to discuss the objections with the parties and make a decision on the record before the hearing at the prehearing conference. However, we noted that the ALJ's decision on an objection to the issues at a prehearing conference pursuant to proposed § 405.1024(c) would not be subject to the objection process for a prehearing conference order under § 405.1040(d). We stated in the proposed rule that a decision on an objection to the issues is not an agreement or action resulting from the prehearing conference, but rather the ALJ's decision on a procedural matter for which the ALJ has discretion, and we do not believe the parties should have a right of veto through the prehearing conference order objection process. We also proposed at § 423.2024(c) to adopt a corresponding revision for a decision on an objection to the issues in part 423, subpart U proceedings.
Provided below are summaries of the specific comments received and responses to these comments:
After review and consideration of the comments received, for the reasons discussed above and in the proposed rule, we are finalizing the changes to §§ 405.1022, 405.1024, 423.2022, and 423.2024 as proposed without modification.
As described below, we proposed several changes to § 405.1026, which provides a process for a party to request that an ALJ disqualify himself or herself from an appeal, or for an ALJ to disqualify himself or herself from an appeal on the ALJ's own motion. 81 FR 43790, 43828. We proposed to revise § 405.1026 to replace the current references to conducting a hearing with references to adjudicating an appeal, to make it is clear that disqualification is not limited to ALJs or cases where a hearing is conducted to help ensure that an attorney adjudicator, as proposed in section II.B of the proposed rule (and discussed in section II.A.2 above), also cannot adjudicate an appeal if he or she is prejudiced or partial to any party, or has any interest in the matter pending for decision. Current § 405.1026(b) requires that, if a party objects to the ALJ who will conduct the hearing, the party must notify the ALJ within 10 calendar days of the date of the notice of hearing. The ALJ considers the party's objections and decides whether to proceed with the hearing or withdraw. However, the current rule does not address appeals for which no hearing is scheduled and/or no hearing will be conducted. Therefore, we proposed to revise § 405.1026(b) to require that if a party objects to the ALJ or attorney adjudicator assigned to adjudicate the appeal, the party must notify the ALJ within 10 calendar days of the date of the notice of hearing if a hearing is scheduled, or the ALJ or attorney adjudicator any time before a decision, dismissal order, or remand order is issued if no hearing is scheduled. We also proposed to revise § 405.1026(c) to state that an ALJ or attorney adjudicator is “assigned” to adjudicate an appeal, rather than “appointed,” for consistency in terminology, and to replace “hearing decision” with “decision or dismissal” because not all decisions are issued following a hearing and an appellant may have objected in an appeal that was dismissed, for which review may also be requested from the Council. In addition, we proposed to add “if applicable” in discussing that the Council would consider whether a new hearing is held because not all appeals may have had or require a hearing. We proposed at § 423.2026 to adopt corresponding revisions for disqualification of an ALJ or attorney adjudicator in part 423, subpart U proceedings.
Section 405.1026 does not address the impact of a party's objection and adjudicator's withdrawal on an
Provided below is a summary of the specific comment received and our response to this comment:
With regard to the commenter's suggestion that the regulations should allow a peremptory challenge by which a party can request reassignment to a different adjudicator without providing a specific objection, we disagree. We do not believe that preemptory challenges would be appropriate or necessary at the OMHA level. A peremptory challenge is generally a feature of a trial by jury that allows attorneys for each side to reject a limited number of jurors without stating a reason for the challenge and without the judge's approval. The concept of a peremptory challenge is to allow both sides to contribute to the jury's composition to help ensure an unbiased result. Under 5 U.S.C. 3105, ALJs must be assigned to cases in rotation so far as practicable, and current §§ 405.1026 and 423.2026 help ensure an unbiased result by requiring the ALJ to withdraw if he or she is prejudiced or partial to any party or has any interest in the matter pending for decision.
We believe allowing parties to request reassignment of an ALJ without explaining the basis for objecting to the ALJ is contrary to the principles of random rotational assignments and would be disruptive and inefficient in processing appeals. The recommendation would add a new administrative burden in reassigning appeals, resulting in an overall decrease in the efficient adjudication of appeals. Furthermore, we believe that the option of a peremptory challenge would further increase administrative burdens and inefficiencies in cases involving multiple parties, where the option of a preemptory challenge would need to be extended to all parties to the appeal. In addition, permitting an appellant to exercise a peremptory challenge in the manner suggested may lead to abuses such as forum shopping or retaliation against an ALJ or an attorney adjudicator for a prior decision with which the party did not agree, even if the ALJ's decision was supported by the evidence and affirmed on appeal to the Council. Also, peremptory challenges potentially used for reasons that have nothing to do with bias would go unrebutted and may undermine the public's confidence in the appeals process. We believe that the potential for abuse, and the administrative burdens and inefficiencies associated with allowing a peremptory challenge outweigh any potential benefit to the adjudication process. In addition, we believe that the disqualification process in §§ 405.1026 and 423.2026 as finalized in this rule, and the opportunity to appeal to the Council any objection to an ALJ or the decision in a case if the ALJ does not withdraw, afford appellants and other parties with strong protections and remedies to address potential bias. The process outlined in §§ 405.1026 and 423.2026 contemplates that the party specify his or her reasons for objecting to the assigned adjudicator so that the adjudicator may consider the reasons and make an informed decision as to whether he or she is prejudiced or partial to any party, or has any interest in the matter pending for decision, and therefore whether to proceed with the appeal or withdraw as the adjudicator. If the adjudicator does not withdraw, the party may request review of the adjudicator's action by the Council. When a reason is provided for the party's objection, even if it is a cursory reason, it is preserved in the record and the Council's review will therefore be better informed. Because the regulations already provide a process by which a party can object to an assigned adjudicator, and an opportunity to have the Council review the objections in cases where an adjudicator does not withdraw, we do not believe a peremptory challenge is necessary.
After review and consideration of the comments received, for the reasons discussed above and in the proposed rule, we are finalizing the changes to §§ 405.1026 and 423.2026 as proposed without modification.
As discussed below, we proposed several revisions to § 405.1028, which addresses the prehearing review of evidence submitted to the ALJ. 81 FR 43790, 43828-43830. We proposed to revise the title of § 405.1028 to reflect that the regulation would more broadly apply to the review of evidence submitted by the parties because a hearing may not be conducted and an attorney adjudicator would review evidence in deciding appeals as proposed in section II.B of the proposed rule (and discussed in section II.A.2 of this final rule above).
We proposed at § 405.1028(a) to incorporate current § 405.1028(a) to address new evidence. Current
In a 2012 OIG report on the ALJ hearing process (OEI-02-10-00340), the OIG reported concerns regarding the acceptance of new evidence in light of the statutory limitation at section 1869(b)(3) of the Act on new evidence submitted by providers and suppliers. The OIG concluded that the current regulations regarding the acceptance of new evidence provide little guidance and only one example of good cause, and recommended revising the regulations to provide additional examples and factors for ALJs to consider when determining good cause.
Section 1869(b)(3) of the Act states that a provider or supplier may not introduce evidence in any appeal that was not presented at the QIC reconsideration unless there is good cause which precluded the introduction of such evidence at or before that reconsideration. We stated in the proposed rule that this section presents a Medicare-specific limitation on submitting new evidence, and therefore limits the authority of an ALJ to accept new evidence under the broader APA provisions (see 5 U.S.C. 556(c)(3) (“Subject to published rules of the agency and within its power, employees presiding at hearings may— . . . receive relevant evidence . . . .”)). We also stated that section 1869(b)(3) of the Act presents a clear intent by Congress to limit the submission of new evidence after the QIC reconsideration, which must be observed.
In light of the OIG conclusion and recommendation and to more effectively implement section 1869(b)(3) of the Act, we proposed to incorporate current § 405.1028(b) in proposed § 405.1028(a)(2) on when an ALJ could find good cause for submitting evidence for the first time at the OMHA level, and to establish four additional circumstances in which good cause for submitting new evidence may be found. We also proposed to permit an attorney adjudicator to find good cause because attorney adjudicators would be examining new evidence in deciding appeals on requests for an ALJ hearing as proposed in section II.B of the proposed rule (and discussed in section II.A.2 of this final rule above), and we stated in the proposed rule that we believed the same standard for considering evidence should apply.
We proposed in § 405.1028(a)(2)(i) to adopt the example in current § 405.1028(b) and provide that good cause is found when the new evidence is, in the opinion of the ALJ or attorney adjudicator, material to an issue addressed in the QIC's reconsideration and that issue was not identified as a material issue prior to the QIC's reconsideration.
We proposed in § 405.1028(a)(2)(ii) to provide that good cause is found when the new evidence is, in the opinion of the ALJ, material to a new issue identified in accordance with § 405.1032(b). This would provide parties with an opportunity to submit new evidence to address a new issue that was identified after the QIC's reconsideration. We stated, however, that the authority is limited to ALJs because, as discussed in proposed § 405.1032, only an ALJ may raise a new issue on appeal.
We proposed in § 405.1028(a)(2)(iii) to provide that good cause is found when the party was unable to obtain the evidence before the QIC issued its reconsideration and the party submits evidence that, in the opinion of the ALJ or attorney adjudicator, demonstrates that the party made reasonable attempts to obtain the evidence before the QIC issued its reconsideration. For example, if specific medical records are necessary to support a provider's or supplier's claim for items or services furnished to a beneficiary, the provider or supplier must make reasonable attempts to obtain the medical records, such as requesting records from a beneficiary or the beneficiary's physician when it became clear the records are necessary to support the claim, and following up on the request. We stated in the proposed rule that obtaining medical records, in some cases from another health care professional, and submitting those records to support a claim for services furnished to a beneficiary is a basic requirement of the Medicare program (see sections 1815(a) and 1833(e) of the Act, and § 424.5(a)(6)), and we expect instances where records cannot be obtained in the months leading up to a reconsideration should be rare. We stated that if the provider or supplier was unable to obtain the records prior to the QIC issuing its reconsideration, good cause for submitting the evidence after the QIC's reconsideration could be found when the ALJ or attorney adjudicator determines that the provider or supplier submitted evidence that demonstrates the party made reasonable attempts to obtain the evidence before the QIC issued its reconsideration.
We proposed at § 405.1028(a)(2)(iv) to provide that good cause is found when the party asserts that the evidence was submitted to the QIC or another contractor and the party submits evidence that, in the opinion of the ALJ or attorney adjudicator, demonstrates that the new evidence was indeed submitted to the QIC or another contractor before the QIC issued the reconsideration. For example, if a provider or supplier submitted evidence to the QIC or another contractor and, through administrative error, the evidence was not associated with the record that is forwarded to OMHA, good cause may be found when the ALJ or attorney adjudicator determines that the provider or supplier submitted evidence that demonstrates the new evidence was submitted to the QIC or another contractor before the QIC issued the reconsideration.
Finally, we proposed at § 405.1028(a)(2)(v) to provide that in circumstances not addressed in proposed paragraphs (i) through (iv), the ALJ or attorney adjudicator may find good cause for new evidence when the
To accommodate the new structure of proposed § 405.1028, we proposed that current paragraphs (c) and (d) be re-designated as paragraphs (a)(3) and (a)(4), respectively. In addition, we proposed at § 405.1028(a)(4) that notification about whether the evidence would be considered or excluded applies only when a hearing is conducted, and notification of a determination regarding new evidence would be made only to parties and participants who responded to the notice of hearing, since all parties may not be sent a copy of the notice of hearing or attend the hearing. We noted that if a hearing is not conducted, whether the evidence was considered or excluded would be discussed in the decision, pursuant to proposed § 405.1046(a)(1), as discussed in section III.A.3.v of the proposed rule and II.B.3.v of this final rule below. We also proposed at § 405.1028(a)(4) that the ALJ would notify all parties and participants whether the new evidence would be considered or is excluded from consideration (rather than only whether the evidence will be excluded from the hearing) and that this determination would be made no later than the start of the hearing, if a hearing is conducted. We stated that if evidence is excluded, it is excluded from consideration at all points in the proceeding, not just the hearing, and evidence may be excluded from consideration even when no hearing is conducted. We stated that we believe that this would provide greater clarity to parties and participants regarding the ALJ's determination with respect to new evidence, and the effect of the exclusion of such evidence on the proceedings.
Current § 405.1028 does not address duplicative evidence. We stated in the proposed rule that duplicative evidence is a significant challenge for OMHA because appellants often submit copies of medical records and other submissions that were filed at prior levels of appeal and are in the record forwarded to OMHA. While we recognize that appellants want to ensure the evidence is in the record and considered, we are also mindful that the APA provides that as a matter of policy, an agency shall provide for the exclusion of unduly repetitious evidence (see 5 U.S.C 556(d)).
We proposed in § 405.1028(b) that the ALJ or attorney adjudicator may exclude from consideration any evidence submitted by a party at the OMHA level that is duplicative of evidence already in the record forwarded to OMHA. In addition to establishing a general policy for the exclusion of unduly repetitious evidence, we stated that this would reduce confusion as to which of the multiple copies of records to review, and would reduce administrative burden.
Provided below are summaries of the specific comments received and responses to these comments:
After review and consideration of the comments received, for the reasons discussed above and in the proposed rule, we are finalizing the changes to § 405.1028 as proposed without modification.
The APA provides an ALJ with the authority to regulate the course of a hearing, subject to the rules of the agency (see 5 U.S.C. 556(c)(5)). As discussed below, we proposed several revisions to §§ 405.1030 and 423.2030, which address ALJ hearing procedures. 81 FR 43790, 43830-43832. We stated in the proposed rule that in rare circumstances, OMHA ALJs have encountered a party or representative that makes it difficult or impossible for the ALJ to regulate the course of a hearing, or for other parties to present their side of the dispute. This may occur when a party or representative continues to present testimony or argument on a matter that is not relevant to the issues before the ALJ, or on a matter for which the ALJ believes he or she has sufficient information or on which the ALJ has already ruled. This may also occur when a party or representative is uncooperative, disruptive, or abusive during the course of the hearing. Sections 405.1030 and 423.2030 set forth the rules that govern ALJ hearing procedures. We proposed to revise §§ 405.1030(b) and 423.2030(b) to add provisions to address these circumstances in a consistent manner that protects the interests of the parties
We proposed in § 405.1030(b)(2) to address circumstances in which a party or representative continues with testimony and argument that are not relevant to the issues before the ALJ or that address a matter for which the ALJ believes he or she has sufficient information or on which the ALJ has already ruled. In these circumstances, the ALJ may limit testimony and/or argument at the hearing, and may, at the ALJ's discretion, provide the party or representative with an opportunity to submit additional written statements and affidavits on the matter in lieu of testimony and/or argument at the hearing, within a time frame designated by the ALJ. Proposed § 405.1030(b)(2) would allow the ALJ to effectively regulate the course of the hearing by providing the ALJ with the clear authority to limit testimony and/or argument during the hearing, while providing an avenue for the ALJ to allow the testimony and/or argument to be entered into the record. We proposed at § 423.2030(b)(2) to adopt a corresponding revision for limiting testimony and argument at a hearing, and at the ALJ's discretion, provide an opportunity to submit additional written statements and affidavits in part 423, subpart U proceedings.
We proposed at § 405.1030(b)(3) to address circumstances in which a party or representative is uncooperative, disruptive, or abusive during the course of the hearing. In these circumstances, we proposed that the ALJ would have the clear authority to excuse the party or representative from the hearing and continue with the hearing to provide the other parties and participants with the opportunity to offer testimony and/or argument. However, we stated in the proposed rule that in this circumstance, the ALJ would be required to provide the excused party or representative with an opportunity to submit written statements and affidavits in lieu of testimony and/or argument at the hearing. Further, we stated that the party also would be allowed to request a copy of the audio recording of the hearing in accordance with § 405.1042 and respond in writing to any statements made by other parties or participants and/or testimony of the witnesses at the hearing, within a time frame designated by the ALJ. These proposals would allow the ALJ to effectively regulate the course of the hearing and balance the excused party's right to present his or her case, present rebuttal evidence, and cross-examine the witnesses of other parties with allowing the party to submit written statements and affidavits. We proposed at § 423.2030(b)(3) to adopt a corresponding revision for excusing an enrollee or representative who is uncooperative, disruptive, or abusive during the hearing in part 423, subpart U proceedings.
Current § 405.1030(c) addresses evidence that the ALJ determines is missing at the hearing, and provides that if the evidence is in the possession of the appellant, and the appellant is a provider, supplier, or a beneficiary represented by a provider or supplier, the ALJ must determine whether the appellant had good cause for not producing the evidence earlier. We proposed to revise § 405.1030(c) to add that the ALJ must determine whether the appellant had good cause in accordance with § 405.1028 for not producing the evidence. Section 1869(b)(3) of the Act applies to limit submission of all new evidence after the QIC reconsideration by a provider or supplier absent good cause, and the proposed addition would create consistent application of the standards for determining whether there is good cause to admit new evidence, regardless of when the evidence is submitted after the QIC reconsideration. We did not propose any corresponding changes to current § 423.2030(c) because the limitation on new evidence does not apply in part 423, subpart U proceedings.
Current § 405.1030(d) and (e) discuss what happens if an ALJ determines there was or was not good cause for not producing the new evidence earlier. Current § 405.1030(d) provides that if the ALJ determines that good cause exists, the ALJ considers the evidence in deciding the case, and the adjudication period is tolled from the date of the hearing to the date that the evidence is submitted. Current § 405.1030(e) provides that if the ALJ determines that good cause does not exist, the evidence is excluded, with no impact on an applicable adjudication period. We stated in the proposed rule that current § 405.1030(d) and (e) have caused confusion in light of § 405.1018, which indicates that the adjudication period will be affected if evidence is submitted later than 10 calendar days after receipt of the notice of hearing, unless the evidence is submitted by an unrepresented beneficiary. We stated that it has also potentially created an incentive for appellants to disregard § 405.1018 because current § 405.1030(b) appears to allow evidence to be submitted at the hearing without affecting the adjudication time frame; and § 405.1030(c) allows the ALJ to stop a hearing temporarily if there is material evidence missing, with the effect of tolling the adjudication time frame (under § 405.1030(d)) from the date of the hearing to the date the evidence is submitted, if the evidence is in the possession of an appellant who is a provider or supplier or beneficiary represented by a provider or supplier, and the ALJ finds good cause to admit the evidence. In addition, we stated that OMHA ALJs have expressed concern that current § 405.1030(e) does not affect the adjudication period when an equal amount of time is spent reviewing evidence and making a good cause determination, regardless of whether good cause is found.
Therefore, we proposed to revise § 405.1030(d) to address the effect of an evidentiary submission on an adjudication period. We proposed in § 405.1030(d) that any applicable adjudication period is extended in accordance with proposed § 405.1018(b) if an appellant other than an unrepresented beneficiary submits evidence pursuant to proposed § 405.1030(b), which generally allows for submission of evidence at the hearing, or proposed § 405.1030(c), which specifically addresses evidence that the ALJ determines is missing at the hearing. Under proposed § 405.1018(b), any adjudication period that applies to the appeal would be extended by the number of days starting 10 calendar days after receipt of the notice of hearing, and ending when the evidence is submitted, whether it is at the hearing pursuant to proposed § 405.1030(b)(1), or at a later time pursuant to proposed § 405.1030(c). We stated that proposed § 405.1030(d) would provide appellants with an incentive to submit evidence they wish to have considered early in the adjudication process, allow the ALJ to consider the evidence and effectively prepare for the hearing, and minimize any delays in the adjudication process resulting from the late introduction of evidence during the hearing process. We further stated that proposed § 405.1030(d) would also remove the potential incentive to disregard § 405.1018, and reconcile any inconsistency in the effect of a late evidentiary submission on an applicable
Continuing a hearing is referenced in current § 405.1030(c), but is not otherwise addressed in part 405, subpart I. We proposed in § 405.1030(e)(1) that a hearing may be continued to a later date and that the notice of the continued hearing would be sent in accordance with proposed § 405.1022, except that a waiver of the notice of hearing may be made in writing or on the record, and the notice of continued hearing would be sent to the parties and participants who attended the hearing, and any additional parties or potential parties or participants the ALJ determines are appropriate. We stated in the proposed rule that the notice requirement would help ensure that the general hearing notice requirements are met for a continued hearing, but allow a waiver of the notice of hearing to be made in writing or on the record. We stated that we believe the added option of waiving the notice of hearing on the record in the context of a continued hearing would facilitate scheduling the continued hearing when all parties and participants who are in attendance at the hearing agree to the continued hearing date, or alternatively agree on the record to the notice being mailed, transmitted, or served fewer than 20 calendar days before the hearing. In addition, proposed § 405.1030(e)(1) would only require that a notice of the continued hearing be sent to the participants and parties who attended the hearing, but would provide the ALJ with the discretion to also send the notice to additional parties, or potential parties or participants. We stated that we believe that a notice of the continued hearing to a party, or potential party or participant, who did not attend the hearing is not necessary unless the ALJ determines otherwise based on the circumstances of the case. In the event that the appellant requested the continuance and an adjudication period applies to the appeal, we proposed in § 405.1030(e)(2) to provide that the adjudication period would be extended by the period between the initial hearing date and the continued hearing date. We stated that we believe an appellant's request for a continuance of the hearing is similar to an appellant's request to reschedule a hearing, and if the request is granted, the adjudication period for the appellant's request for hearing should be adjusted accordingly. We proposed at § 423.2030(e) to adopt corresponding provisions for continued hearings in part 423, subpart U proceedings.
On occasion, after a hearing is conducted, ALJs find that additional testimony or evidence is necessary to decide the issues on appeal, or a procedural matter needs to be addressed. Current § 405.1030(f) allows an ALJ to reopen a hearing to receive new and material evidence pursuant to § 405.986, which requires that the evidence (1) was not available or known at the time of the hearing, and (2) may result in a different conclusion. However, current § 405.1030(f) does not provide a mechanism to address procedural matters, or to obtain additional information through evidence or testimony that may have been available at the time of hearing and may result in a different outcome but the importance of which was not recognized until after a post-hearing review of the case. We proposed in § 405.1030(f)(1) to remove the “reopen” label and provide for a “supplemental” hearing rather than reopening the hearing to distinguish it from reopening a decision and the standards for reopening a decision. We also proposed that a supplemental hearing may be conducted at the ALJ's discretion at any time before the ALJ mails a notice of decision in order to receive new and material evidence, obtain additional testimony, or address a procedural matter. We stated in the proposed rule that the ALJ would determine whether a supplemental hearing is necessary, and if one is held, the scope of the supplemental hearing, including when evidence is presented and what issues are discussed. In addition, we proposed at § 405.1030(f)(1) that a notice of the supplemental hearing be sent in accordance with § 405.1022 to the participants and parties who attended the hearing, but would provide the ALJ with the discretion to also send the notice to additional parties, or potential parties or participants the ALJ determines are appropriate. Similar to the proposed notice of a continued hearing explained above, we stated that we believe that a notice of the supplemental hearing to a party, or potential party or participant, who did not attend the hearing is not necessary unless the ALJ determines otherwise based on the circumstances of the case. In the event that the appellant requested the supplemental hearing and an adjudication period applies to the appeal, we proposed at § 405.1030(f)(2) to provide that the adjudication period would be extended by the period between the initial hearing date and the supplemental hearing date. We stated that we believe an appellant's request for a supplemental hearing is similar to an appellant's request for a continuance or to reschedule a hearing, and if the request is granted, the adjudication period for the appellant's request for hearing should be adjusted accordingly. We proposed at § 423.2030(f) to adopt corresponding provisions for supplemental hearings in part 423, subpart U proceedings.
Provided below are summaries of the specific comments received and responses to these comments:
We do not believe that limiting testimony that is unrelated, repetitive, or related to an issue that has been sufficiently developed or upon which the ALJ has already ruled prejudices a party's right to a full and fair hearing. ALJs have a responsibility pursuant to current §§ 405.1030(b) and 423.2030(b) to fully examine the issues on appeal, ensuring that all necessary testimony is considered, which would continue under the these rules as finalized. The proposals at §§ 405.1030(b) and 423.2030(b), which we are finalizing in this rule, would only limit the introduction of repetitive or unrelated evidence. Moreover, the proposal is based on the APA at 5 U.S.C. 556(c)(5), which provides that subject to the published rules of the agency, an ALJ may regulate the course of the hearing. We believe that ALJs, who have a responsibility to ensure both a fully examined and fairly administered hearing, will use these provisions only in the limited situations that the proposals are intended to address.
With regard to the concern that the proposed regulations give too much discretion to the ALJ, we believe such discretion is consistent with and authorized by the APA. As we stated above, we believe the ALJ needs to be able to effectively regulate the course of the hearing, including the exercise of discretion as outlined in the §§ 405.1030(b) and 423.2030(b), as finalized, in order to effectively protect the interest of parties and to preserve the integrity of the hearing process.
With regard to the commenter's concern that limiting testimony or argument would interrupt the logical flow of an argument or make it difficult for the party to present a coherent or rational case, we note that these concerns appear to relate mainly to a party being able to present its case in the manner that he or she believes is most logical, coherent, or rational and do not adequately recognize the ALJ's role in the process. When an ALJ limits testimony or argument at the hearing, it is because the ALJ believes the testimony or argument was not relevant to an issue before the ALJ, was repetitive of evidence or testimony already in the record, or related to an issue that was sufficiently developed, and the ALJ has heard all necessary testimony, understands the arguments being made, and is able to logically, rationally, and fully analyze the issue to make a decision. Moreover, we believe these concerns about being able to present a case in the order and manner an individual desires are outweighed by the ALJ's broader responsibilities to protect the interests of all parties and preserve the integrity of the hearing process. As we discuss above, allowing a party to continue presenting testimony and argument when the testimony or argument is not relevant to an issue before the ALJ, is repetitive of evidence or testimony already in the record, or relates to an issue that has been sufficiently developed, is not only an inefficient use of time and resources, it may have the effect of monopolizing the time set for a hearing and causing other parties to limit their presentations because they have only allowed for the scheduled hearing time in their schedules.
We note that any party that is excused from the hearing pursuant to proposed §§ 405.1030(b)(3) and 423.2030(b)(3) would be permitted to submit written statements and affidavits in lieu of testimony and/or argument at the hearing. Although the commenter noted that written statements would limit an excused party's or representative's ability to present a case or cross examine witnesses and other parties at the hearing, we believe that the required warning would effectively put the excused entity or individual on notice of the consequences of continued uncooperative, disruptive, or abusive behavior, and therefore the excused individuals or entities would have knowingly limited their own argument and testimony to written statements by continuing such behavior. While the format of the argument and testimony would be changed, we disagree with the commenter that written statements and affidavits are necessarily less effective or persuasive than oral argument or testimony or that they curtail due process. The ALJ would give the same weight to argument or testimony that is presented in writing as to argument or testimony that is presented orally at the hearing. Moreover, any excused party would be able to request a copy of the audio recording of the hearing in accordance with §§ 405.1042 and 423.2042 so that the party could respond in writing to any statements or testimony made at the hearing, including the submission of rebuttal argument and evidence.
Finally, we disagree with the commenter's characterization that the type of behavior addressed in §§ 405.1030(b)(3) and 423.2030(b)(3) is synonymous with “spirited or contentious” or that parties or their representatives would refrain from objecting to certain hearing procedures set by the ALJ because they do not want to risk being excused from the hearing. The language used in the regulations—uncooperative, disruptive, or abusive—was specifically chosen to describe a certain degree of behavior that makes it difficult or impossible for an ALJ to regulate the course of a hearing or for other parties to present their side of the dispute. We believe that §§ 405.1030(b)(3) and 423.2030(b)(3) are necessary in order to allow the ALJ to effectively regulate the course of the hearing, including providing the other parties with their opportunity to offer testimony and/or argument. To the extent that a party believes it was inappropriately excused from a hearing, that issue could be raised on appeal to the Council.
The only proposed change to § 405.1030(c)—the provision regarding procedures when an ALJ determines that there is material evidence missing at the hearing in Medicare Part A and Part B cases—is to add a reference to § 405.1028 for consistency regarding the application of the standards for determining whether there is good cause to admit new evidence regardless of when the evidence is submitted after the QIC reconsideration. No changes were proposed for § 423.2030(c)—the corresponding provision regarding procedures when an ALJ determines that there is material evidence missing at the hearing in Medicare Part D cases—because there is no corresponding language requiring good cause for the admission of new evidence in the Medicare Part D regulations as explained above.
After review and consideration of the comments received, for the reasons discussed above and in the proposed rule, we are finalizing the changes to §§ 405.1030 and 423.2030 as proposed, with the following modifications. We are revising §§ 405.1030(b)(2) and 423.2030(b)(2) to provide that the ALJ may limit testimony and/or argument at the hearing that are not relevant to an issue before the ALJ, are repetitive of evidence or testimony already in the record, or that relate to an issue that has been sufficiently developed or on which the ALJ has already ruled. In addition, we are revising §§ 405.1030(b)(3) and 423.2030(b)(3) to add language that a party or party's representative (or enrollee or enrollee's representative in the context of § 423.2030(b)(3)) may be excused from a hearing if that individual remains uncooperative, disruptive to the hearing, or abusive during the course of the hearing after the ALJ has warned the party or representative to stop such behavior.
As described below, we proposed several changes to §§ 405.1032 and 423.2032, which address the issues that are before the ALJ. 81 FR 43790, 43832-43834. We proposed to revise the title of the section to indicate that the proposed provision also would apply to issues before an attorney adjudicator, as proposed in section II.B of the proposed rule (and discussed in section II.A.2 of this final rule above), if an attorney adjudicator is assigned to an appeal.
Current § 405.1032(a) states that the issues before the ALJ include all of the issues brought out in the initial determination, redetermination, or reconsideration that were not decided entirely in a party's favor. However, we stated in the proposed rule that when a request for hearing involves a reconsideration of multiple claims and the appellant does not identify one or more of the claims that were not decided entirely in the party's favor at initial determination, redetermination, or reconsideration, it is unclear whether the ALJ should review all of the claims that were not decided entirely in the party's favor at initial determination, redetermination, or reconsideration, or just those claims specified by the appellant in the request for hearing. An appellant is required to identify the dates of service for the claims that it wishes to appeal in its request for hearing under § 405.1014, and some appellants have indicated that they do not specify a denied claim in a request for hearing when they agree that the record does not support coverage of the claim. To address the ambiguity, and in the interest of efficiency and consistency with § 405.1014, we proposed in § 405.1032(a) that the issues before the ALJ or attorney adjudicator include all the issues for the claims or appealed matter (for example, for appeals that do not involve a claim for items or services furnished to a beneficiary, such as Medicare Secondary Payer appeals and terminations of coverage) specified in the request for hearing that were brought out in the initial determination, redetermination, or reconsideration that were not decided entirely in a party's favor. We proposed at § 423.2032(a) to adopt a corresponding revision for issues in part 423, subpart U proceedings, except the term claims is not used because part 423, subpart U appeals do not involve claims.
Current § 405.1032(a) also notes that if evidence presented before the hearing causes the ALJ to question a favorable portion of the determination, the ALJ notifies the parties before the hearing and may consider it an issue at the hearing. As explained in the 2005 Interim Final Rule (70 FR 11462), this provision relates to the favorable portion of an appealed claim, and that the favorable issue is a new issue that must meet the requirements of current paragraph (b). However, in practice, this provision has been read to allow consideration of separate claims that were decided in a party's favor at lower appeal levels in multiple-claim appeals, and at times read independently from paragraph (b). To address this confusion, we proposed to move this language in § 405.1032(a) to proposed § 405.1032(b), with the revisions discussed below. We proposed at § 423.2032(a) and (b) to adopt corresponding revisions for new issues in part 423, subpart U proceedings.
Current § 405.1032(b) allows new issues to be considered at the hearing if: (1) The ALJ notifies the parties about the new issue before the start of the hearing; (2) the resolution of the new issue could have a material impact on the claim or claims that are the subject of the request for hearing; and (3) its resolution is permissible under the rules governing reopening of determinations and decisions. We proposed at § 405.1032(b) to incorporate these provisions, with the revisions discussed below, as well as the language regarding consideration of favorable issues moved from current § 405.1032(a), in a revised structure.
We proposed in § 405.1032(b)(1) to address when a new issue may be considered. Specifically, we proposed that the ALJ may only consider the new issue, including a favorable portion of a determination on a claim or appealed matter specified in the request for hearing, if its resolution could have a material impact on the claim or
We proposed at § 405.1032(b)(2) to continue to provide that notice of the new issue must be provided before the start of the hearing, but would limit the notice to the parties who were or will be sent the notice of hearing, rather than the current standard to notice “all of the parties.” Because notice of the new issue may be made in the notice of hearing or after the notice of hearing, and parties generally have 10 calendar days after receipt of the notice of hearing to submit evidence, we proposed at § 405.1032(b)(3) to also provide that if notice of the new issue is sent after the notice of hearing, the parties would have at least 10 calendar days after receiving the notice of the new issue to submit evidence regarding the issue. As provided in proposed § 405.1028(a)(2)(ii), the ALJ would then determine whether the new evidence is material to the new issue identified by the ALJ. We also stated in the proposed rule that if an adjudication time frame applies to the appeal, the adjudication period would not be affected by the submission of evidence. Further, we proposed at § 405.1032(b)(3) that if the hearing is conducted before the time to submit evidence regarding the issue expires, the record would remain open until the opportunity to submit evidence expires to provide the parties sufficient time to submit evidence regarding the issue. We proposed at § 423.2032(b)(2) and (b)(3) to adopt corresponding provisions for providing notice of new issues to enrollees and an opportunity to submit evidence, and to add that an enrollee will have 2 calendar days after receiving notice of the new issue in an expedited appeal to submit evidence, which corresponds to the length of time permitted under proposed § 423.2018(c) to submit evidence after receiving a notice of expedited hearing.
Current § 405.1032(c) states that an ALJ cannot add any claim, including one that is related to an issue that is appropriately before an ALJ, to a pending appeal unless the claim has been adjudicated at the lower appeal levels and all parties are notified of the new issues before the start of the hearing. However, in practice, we are unaware that this provision is used, and to the extent it may be used, we believe it would be disruptive to the adjudication process, result in filing requirements not being observed, and risk adjudication of the same claim by multiple adjudicators. Therefore, we proposed to maintain the topic of adding claims to a pending appeal, but replace the language of current § 405.1032(c), as explained below.
A reconsideration may be appealed for an ALJ hearing regardless of the number of claims involved in the reconsideration. However, we recognize that a party may not specify all of the claims from a reconsideration that he or she wishes to appeal in the party's request for hearing. We proposed in § 405.1032(c)(1) to address this circumstance by providing that claims that were not specified in a request for hearing may only be added to a pending appeal if the claims were adjudicated in the same reconsideration that is appealed in the request for hearing, and the period to request an ALJ hearing for that reconsideration has not expired, or an ALJ or attorney adjudicator extends the time to request an ALJ hearing on those claims to be added in accordance with proposed § 405.1014(e). We stated in the proposed rule that we believe that this would result in less disruption to the adjudication process, greater adherence to filing requirements, and reduce the risk of adjudication of the same claim by multiple adjudicators. To help ensure that the copy requirement of proposed § 405.1014(d) is observed, we proposed at § 405.1032(c)(2) to require that before a claim may be added to a pending appeal, the appellant must submit evidence that demonstrates that the information that constitutes a complete request for hearing in accordance with § 405.1014(b) and other materials related to the claim that the appellant seeks to add to the pending appeal were sent to the other parties to the claim in accordance with § 405.1014(d). We proposed at § 423.2032(c) to adopt a provision corresponding to proposed § 405.1032(c)(1), but we did not propose to adopt a provision corresponding to § 405.1032(c)(2) because there is no § 423.2014 requirement for an enrollee to send a copy of his or her request to others.
Current § 405.1032 does not address issues related to an appeal that involves a disagreement with how a statistical sample and/or extrapolation was conducted. When an appeal involves a statistical sample and an extrapolation and the appellant wishes to challenge how the statistical sample and/or extrapolation was conducted, as discussed previously, we proposed at § 405.1014(a)(3)(iii) to require the appellant to assert the reasons the appellant disagrees with how the statistical sampling and/or extrapolation was conducted in the request for hearing. We proposed at § 405.1032(d)(1) to reinforce this requirement by excluding issues related to how the statistical sample and/or extrapolation were conducted if the appellant does not comply with § 405.1014(a)(3)(iii). In addition to reinforcing the proposed requirement at § 405.1014(a)(3)(iii), we stated in the proposed rule that we believed that excluding the issue is appropriate because an appellant should reasonably be aware of whether it disagrees with how the statistical sampling and/or extrapolation was conducted at the time it files a request for hearing, and raising the issue later in the adjudication process or at the hearing can cause significant delays in adjudicating an appeal because the ALJ may need to conduct additional fact finding, find it necessary to request participation of CMS or one of its contractors, and/or call expert witnesses to help address the issue.
Related to the issues that an ALJ must consider, the 2005 Interim Final Rule (70 FR 11466) explained that current § 405.1064 was added to set forth a general rule regarding ALJ decisions that are based on statistical samples because a decision that is based on only a portion of a statistical sample does not accurately reflect the entire record. As discussed in the 2009 Final Rule (74 FR 65328), current § 405.1064 explains that when an appeal from the QIC involves an overpayment, and the QIC used a statistical sample in reaching its reconsideration, the ALJ must base his or her decision on a review of all claims in the sample. However, we stated in the proposed rule that while a review of the claims selected for the sample is necessary to review issues related to a
To clarify what is at issue and what must be considered in appeals involving statistical sampling and extrapolations, we proposed to remove current § 405.1064, and address the matter in § 405.1032(d)(2). We proposed in § 405.1032(d)(2) that if a party asserts a disagreement with how the statistical sampling methodology and extrapolation were conducted in the request for hearing, in accordance with proposed § 405.1014(a)(3)(iii), § 405.1032(a) through (c) would apply to the adjudication of the sample claims. The result of applying proposed § 405.1032(a) and (b) would be that only the sample units that were specified in the request for hearing are individually adjudicated, subject to a new issue being identified for an appealed claim. However, proposed § 405.1032(c) would permit adding sample claims to a pending appeal if they were adjudicated in the appealed reconsideration and the time to request a hearing on the reconsideration has not expired, or the ALJ or attorney adjudicator extends the time to request an ALJ hearing on those claims in accordance with § 405.1014(e). To incorporate the principle embodied in current § 405.1064, we proposed in § 405.1032(d)(2) that in deciding issues related to how a statistical sample and/or extrapolation was conducted, the ALJ or attorney adjudicator would base his or her decision on a review of the entire sample to the extent appropriate to decide the issue. We stated in the proposed rule that we believed this more clearly conveys the intent of the rule and recognizes that an individual adjudication of each claim in the sample is not always necessary to decide an issue related to how a statistical sample and/or extrapolation was conducted, such as whether there is documentation so that the sampling frame can be re-created, as required by the Medicare Program Integrity Manual (Internet-Only Manual 100-08) (see chapter 8, section 8.4.4.4.1). We did not propose any corresponding changes in § 423.2030 because statistical sampling and extrapolation are not currently used for matters that are subject to part 423, subpart U proceedings.
Provided below is a summary of the specific comment received and our response to this comment:
In addition to existing CMS resources like the Medicare & You Handbook, 1-800 Medicare, chapter 29 of the Medicare Claims Processing Manual (Internet-Only Manual 100-4), and the Medicare claims appeals Web site at
OMHA also has a toll free beneficiary help line for Medicare beneficiaries and Part C or Part D plan enrollees who have questions about or need assistance with a request for an ALJ hearing, as well as a separate OMHA national toll free assistance line for other appellants. Information about both help lines can be found on the “Contact OMHA” portion of the OMHA Web site (
After review and consideration of the comment received, for the reasons discussed above and in the proposed rule, we are finalizing our proposals to revise §§ 405.1032 and 423.2032 and to remove § 405.1064 without modification.
Current §§ 405.1034 and 423.2034 describe when an ALJ may request information from, or remand a case to a QIC or IRE. When the ALJ believes that the written record is missing information that is essential to resolving the issues on appeal and that information can be provided only by CMS or its contractors, including an IRE, or the Part D plan sponsor, current §§ 405.1034(a) and 423.2034(a) allow an ALJ to remand the case to the QIC or IRE that issued the reconsideration, or retain jurisdiction of the case and request that the entity forward the missing information to the appropriate hearing office. The 2005 Interim Final Rule (70 FR 11465) explained that in the rare instance in which the file lacks necessary technical information that can only be provided by CMS or its contractors, it was believed that the most effective way of completing the record is to return the case, via remand, to the contractor; however, the ALJ also had the option of asking the entity to forward the missing information to the ALJ hearing office. We stated in the proposed rule that, in practice, stakeholders have expressed frustration and concern with the remand provisions
To address stakeholders' concerns with the current remand provisions, and areas not addressed in current §§ 405.1034 and 423.2034, we proposed to revise the sections to cover obtaining information that can be provided only by CMS or its contractors, or the Part D plan sponsor, and establishing new §§ 405.1056 and 405.1058 to address remands to a QIC, and new §§ 423.2056 and 423.2058 to address remands to an IRE. 81 FR 43790, 43834-43836.
We proposed in § 405.1034(a) to maintain the current standards for requesting information that is missing from the written record when that information can be provided only by CMS or its contractors, but limit the action to a request for information directed to the QIC that conducted the reconsideration or its successor (if a QIC contract has been awarded to a new contractor). In addition, we proposed to review § 405.1034(a) to include attorney adjudicators because attorney adjudicators would be authorized to adjudicate appeals, as proposed in section II.B of the proposed rule (and discussed in section II.A.2 of this final rule above). Also, while we proposed to retain the definition of “can be provided only by CMS or its contractors” in § 405.1034(a)(2), we proposed at § 405.1034(a)(1) to specify that official copies of redeterminations and reconsiderations that were conducted on the appealed claims can be provided only by CMS or its contractors. The redetermination and reconsideration are important documents that establish the issues on appeal, and while the parties often have copies of them, we stated in the proposed rule that we believed the record should include official copies from the contractors. In addition, we proposed at § 405.1034(b) to specify that the ALJ or attorney adjudicator would retain jurisdiction of the case, and the case would remain pending at OMHA. We proposed at § 423.2034(a) and (b) to adopt corresponding provisions for when information may be requested from an IRE and that jurisdiction is retained at OMHA in part 423, subpart U proceedings.
We proposed in § 405.1034(c) that the QIC would have 15 calendar days after receiving the request for information to furnish the information or otherwise respond to the request for information, either directly or through CMS or another contractor. We stated that this would provide the ALJ or attorney adjudicator, the QIC, and the parties with a benchmark for obtaining the information and determining when adjudication of the case can resume. We proposed in § 405.1034(d) that, if an adjudication period applies to the appeal in accordance with § 405.1016, the adjudication period would be extended by the period between the date of the request for information and the date the QIC responds to the request or 20 calendar days after the date of the request, whichever is less. We stated that we recognize that other provisions that extend an applicable adjudication period generally involve an appellant's action or omission that delays adjudicating an appeal within an applicable time frame, but we stated in the proposed rule that we believed that an extension is also warranted to fully develop the record when the written record is missing information that is essential to resolving the issues on appeal, and that 20 calendar days (5 calendar days for the request to be received by the QIC and 15 calendar days for the QIC to respond) is a relatively modest delay in order to obtain missing information that is essential to resolving the appeal. We proposed at § 423.2034(c) and (d) to adopt corresponding provisions for the IRE to furnish the information or otherwise respond to the request for information, either directly or through CMS or the Part D plan sponsor, and the effect on any applicable adjudication time frame in part 423, subpart U proceedings. In addition, we proposed at § 423.2034(c) and (d) to provide for an accelerated response time frame for expedited appeals because of the urgency involved. For expedited appeals, we proposed that the IRE would have 2 calendar days after receiving a request for information to furnish the information or otherwise respond to the request, and the extension to the adjudication time frame would be up to 3 calendar days, to allow for time to transmit the request to the IRE and for the IRE to respond.
We proposed to add new § 405.1056 to describe when a request for hearing or request for review of a QIC dismissal may be remanded, and new § 405.1058 to describe the effect of a remand. We proposed in § 405.1056(a)(1) to permit a remand if an ALJ or attorney adjudicator requests an official copy of a missing redetermination or reconsideration for an appealed claim in accordance with proposed § 405.1034, and the QIC or another contractor does not furnish the copy within the time frame specified in § 405.1034. We also proposed in § 405.1056(a)(2) to permit a remand when the QIC does not furnish a case file for an appealed reconsideration. The remand under both provisions would direct the QIC or other contractor (such as a Medicare Administrative Contractor that made the redetermination) to reconstruct the record or initiate a new appeal adjudication. We stated in the proposed rule that we expected this type of remand to be very rare, but we also stated that we believed it was necessary to help ensure a complete administrative record of the administrative adjudication of a claim. To address the possibility that the QIC or another contractor is able to reconstruct the record for a remanded case, we proposed in § 405.1056(a)(3) to provide that in the situation where a record is reconstructed by the QIC, the reconstructed record would be returned to OMHA, the case would no longer be remanded and the reconsideration would no longer be vacated, and if an adjudication period applies to the case, the period would be extended by the time between the date of the remand and the date the case is returned to OMHA (because OMHA was unable to adjudicate the appeal between when it was remanded and when it was returned to OMHA). We stated that this would help ensure that appellants are not required to re-start the ALJ hearing or dismissal review process in the event that the QIC or another contractor is able to reconstruct the record. We proposed at § 423.2056(a) to adopt corresponding provisions for remanding cases in which there is a missing appeal determination or the IRE is unable to furnish the case file in part 423, subpart U proceedings.
On occasion, an ALJ finds that a QIC issued a reconsideration that addresses coverage or payment issues related to the appealed claim when a redetermination was required and no redetermination was conducted, or the contractor dismissed the request for redetermination and the appellant appealed the contractor's dismissal. We stated in the proposed rule that, in either circumstance, the reconsideration was issued in error because the appellant did not have a right to the reconsideration in accordance with current § 405.960, which only provides a right to a reconsideration when a redetermination is made by a contractor.
OMHA ALJs sometimes receive requests for remands from CMS or a party because the matter can be resolved by a CMS contractor if jurisdiction of the claim is returned to the QIC. Current § 405.1034 does not address this type of request. We proposed at § 405.1056(c)(1) to provide a mechanism for these remands. Specifically, we proposed that at any time prior to an ALJ or attorney adjudicator issuing a decision or dismissal, the appellant and CMS or one of its contractors, may jointly request a remand of the appeal to the entity that conducted the reconsideration. We proposed that the request include the reasons why the appeal should be remanded and indicate whether remanding the case would likely resolve the matter in dispute. Proposed § 405.1056(c)(2) would allow the ALJ or attorney adjudicator to determine whether to grant the request and issue the remand, based on his or her determination of whether remanding the case would likely resolve the matter in dispute. We stated that we believe this added flexibility would allow appellants and CMS and its contractors to expedite resolution of a disputed claim when there is agreement to do so. We proposed at § 423.2056(c) to adopt corresponding provisions for requested remands in part 423, subpart U proceedings.
Current § 405.1034(b) provides that if, consistent with current § 405.1004(b), the ALJ determines that a QIC's dismissal of a request for reconsideration was in error, the case will be remanded to the QIC. We proposed at § 405.1056(d) to incorporate this provision and to adopt a corresponding provision in § 423.2056(d) to incorporate current § 423.2034(b)(1) for remanding cases in which an IRE's dismissal of a request for reconsideration was in error, in part 423, subpart U proceedings. In addition, we proposed at § 423.2056(e) to incorporate current § 423.2034(b)(2), which provides that if an enrollee wants evidence of a change in his or her condition to be considered in the appeal, the appeal would be remanded to the IRE for consideration of the evidence on the change in condition.
Current § 405.1034(c) provides that the ALJ remands an appeal to the QIC that made the reconsideration if the appellant is entitled to relief pursuant to 42 CFR 426.460(b)(1), 426.488(b), or 426.560(b)(1), and provides that unless the appellant is entitled to such relief, the ALJ applies the LCD or NCD in place on the date the item or service was provided. We proposed to incorporate these provisions at § 405.1056(e). We did not propose any corresponding provision for § 423.2056 because there is not a similar current provision for part 423, subpart U proceedings.
As noted above, current § 405.1034 does not address providing a notice of remand. We proposed at § 405.1056(f) to provide that OMHA mails or otherwise transmits a written notice of the remand of the request for hearing or request for review to all of the parties who were sent a copy of the request at their last known address, and CMS or a contractor that elected to be a participant to the proceedings or a party to the hearing. The notice would state that, as discussed below, there is a right to request that the Chief ALJ or a designee review the remand. We stated in the proposed rule that we believed this would help ensure that the parties and CMS and its contractors receive notice that the remand order has been issued. We proposed at § 423.2056(f) to adopt a corresponding provision for a notice of remand in part 423, subpart U proceedings, except that only the enrollee receives notice because only the enrollee is a party, and CMS, the IRE, and the Part D plan sponsor only receive notice if they requested to participate and the request was granted.
Stakeholders have recounted instances in which they believe a remand was not authorized by the regulations, but were unable to take any action to correct the perceived error because a remand is not an appealable action and current § 405.1034 does not provide a review mechanism. We stated that we do not believe that remands should be made appealable actions, but recognize that stakeholders need a mechanism to address remands that they believe are not authorized by the regulation. We proposed in § 405.1056(g) to provide a mechanism to request a review of a remand by allowing a party or CMS, or one of its contractors, to file a request to review a remand with the Chief ALJ or a designee within 30 calendar days of receiving a notice of remand. If the Chief ALJ or designee determines that the remand is not authorized by § 405.1056, the remand order would be vacated. We also proposed that the determination on a request to review a remand order is binding and not subject to further review so adjudication of the appeal can proceed. We proposed at § 423.2056(g) to adopt a corresponding provision for reviewing a remand in part 423, subpart U proceedings.
Current § 405.1034 does not discuss the effect of a remand. We proposed at § 405.1058, similar to current §§ 405.1048 and 405.1054 which describe the effects of a decision and dismissal, respectively, that a remand of a request for hearing or request for review is binding unless it is vacated by the Chief ALJ or a designee in accordance with proposed § 405.1056(g). We stated in the proposed rule that we believed the provision would add clarity for the parties and other stakeholders on the effect of a remand order. We proposed at § 423.2058 to adopt a corresponding provision for the effect of a remand in part 423, subpart U proceedings.
Provided below are summaries of the specific comments received and responses to these comments:
We do not believe that proposed §§ 405.1034(a)(1) and 423.2034(a)(1) place any unnecessary burden on the parties or that they will cause significant delays in the adjudication of appeals. First, we note that in many cases the lower levels decisions are available on a CMS case processing system that is accessible to OMHA. If the missing lower level decision is uploaded to an official system of record (generally the case processing system used by the contractor and accessible to OMHA), then OMHA could accept that document as the official copy. In these cases, no information request would be necessary under §§ 405.1034(a) or 423.2034(a). We are modifying the language in §§ 405.1034(a)(1) and 423.2034(a)(1) to clarify that prior to submitting an information request, OMHA must first check the system of record to confirm whether a copy of the missing lower level decision is available there. In the extremely small number of cases where official copies were not provided in the record and were not uploaded by the contractor to the case processing system, then the ALJ or attorney adjudicator would use the proposed regulations to request an official copy of the missing lower level decision. In these cases, the adjudication period may be extended pursuant to §§ 405.1034(d) or 423.2034(d). However, given the ready availability of such evidence in the contractor's system, it should take minimal time for the contractor to produce the necessary documents, and we would anticipate that the extension also would be minimal.
We do not believe that proposed § 405.1056(b) would apply to the facts that were outlined in the commenter's example. In the example presented in the comment, the contractor did issue a redetermination, albeit a denial on technical grounds. The part 405, subpart I regulations do not make a distinction between redeterminations based on a technical denial and redeterminations based on other reasons, such as a denial because the item or service was not medically reasonable and necessary. Both redeterminations would give the party a right to request a QIC reconsideration on the coverage and payment issues. The party would then have a right to appeal the QIC's reconsideration for an ALJ hearing, provided the amount in controversy and other filing requirements were met, and the remand provisions of proposed § 405.1056(b) would not apply.
Further, proposed § 405.1056(b) applies to any request for hearing on a QIC reconsideration where the QIC issued a coverage and payment decision in error as discussed above. We do not believe there are any special considerations regarding the proposal that would apply differently based on the party appealing the claim, and therefore do not believe adding examples of how the proposal impacts an appeal filed by a beneficiary or a Medicaid State agency will be helpful.
The review mechanisms proposed in §§ 405.1056(g) and 423.2056(g) also are intended to help ensure consistency in processing appeals. Previously, if an appeal was remanded to the QIC or IRE and that level of review did not agree that there was jurisdiction for the remand under current §§ 405.1034 or 423.2034, there was no clear guidance on how to proceed. Some QICs or IREs would reopen the previous decision while others would respond to the remand via a different mechanism. When ALJs issued remand orders outside of the scope of §§ 405.1034 or 423.2034, it created inconsistencies and confusion not only for CMS and its contractors regarding how to proceed, but also for appellants regarding the status and handling of their appeal. The proposed review mechanisms will help ensure that the procedural remand rules are applied in a consistent manner and that the processing of the remands at lower levels is also more uniform.
We limited the review authority to the Chief ALJ or a designee so that limited individuals within the agency will be tasked with this new review responsibility, which is a limited-scope review of a discrete procedural question. In this way, we believe that the requested reviews can be completed both consistently and efficiently. We added the ability for the Chief ALJ to designate other individuals to assist with the review of remands, if necessary, to ensure that there will be adequate resources to complete the reviews as expeditiously as possible, so the appeal can proceed as remanded, or with the ALJ.
We disagree with the commenter that the proposed review mechanisms may be used to reverse ALJ decisions or to override the qualified decisional independence that ALJs have when making decisions. We believe that remands are distinct from the decisions described in sections 554 and 556 of the APA because the permitted remands are generally procedural mechanisms that do not resolve the issues on appeal, but rather return the appeal to the second level of the appeals process without a resolution of the appealed matter. The one exception to this distinction is when the remand is issued on a request for review of a QIC's or IRE's dismissal of a request for reconsideration. In §§ 405.1056(d) and 423.2056(d) as finalized in this rule, an ALJ or attorney adjudicator issues a remand to the appropriate QIC or IRE if the ALJ or attorney adjudicator determines that the dismissal of a request for reconsideration was in error. We
We also do not agree with the commenter that this review mechanism will result in ex parte communications or the appearance of impropriety. Ex parte communications involve communications that are not on the record between an individual involved in the decisional process and an interested party outside of the agency about the merits of the proceedings. See 5 U.S.C. 557(d). The proposed review mechanisms in §§ 405.1056(g) and 423.2056(g) permit either a party or CMS, or one of its contractors, to file a request to review a remand within 30 calendar days of receiving the notice of remand, which would be made part of the record. The proposed regulation provides for the same procedure regardless of the entity or individual requesting the review.
Finally, with respect to the suggested alternative of substantially limiting the ALJs' remand authority, we disagree with the commenter that the stakeholders' concerns that prompted this proposal would be sufficiently addressed by that alternative. The current regulations already substantially limit the ALJs' authority to remand and yet there have been instances, despite those limitations, where stakeholders still felt that remands were issued that were not authorized by the regulations. In addition, §§ 405.1056 and 423.2056, as finalized in this rule, do not expand the ALJs' remand authority compared to the current remand regulations in §§ 405.1034 and 423.2034, but rather they set forth the limited circumstances in which a remand may be issued. Although §§ 405.1056 and 423.2056 list specific situations where a remand may be issued, these provisions are narrower than the current provisions at §§ 405.1034 and 423.2034 because they do not include the general language at §§ 405.1034 and 423.2034 providing for a remand when the ALJ believes the written record is missing information that is essential to resolving the issues on appeal and that information can be provided only by CMS or its contractors. Instead, §§ 405.1034(a) and 423.2034(a), as finalized in this rule, require that the ALJ or attorney adjudicator first request that information from the QIC or IRE. Although the ALJ or attorney adjudicator may still remand a case under §§ 405.1056(a) and 423.2056(a) if the QIC or IRE fail to provide an official copy of a missing redetermination or reconsideration or fail to provide the case file after a request for information under §§ 405.1034(a) and 423.2034(a),, the specific circumstances in which remands can occur have been narrowed as compared to the broader remand authority set forth in current §§ 405.1034 and 423.2034. Because remands are only available in limited and narrowly defined circumstances in §§ 405.1056 and 423.2056, we anticipated that the review mechanisms created by this proposal will be used infrequently. We agree with the commenter that remands are rarely used today and, therefore, believe that the use of the review mechanisms proposed in §§ 405.1056(g) and 423.2056(g) would be even rarer.
After review and consideration of the comments received, for the reasons discussed above and in the proposed rule, we are finalizing §§ 405.1058 and 423.2058 as proposed without modification, and we are finalizing the changes to §§ 405.1034, 405.1056, 423.2034, and 423.2056 as proposed, with the following modifications. We are amending §§ 405.1034(a)(1) and 423.2034(a)(1) to provide that prior to issuing a request for information to the QIC or IRE, OMHA will confirm whether an electronic copy of the missing redetermination or reconsideration is available in the official system of record, and if so, will accept the electronic copy as an official copy. In addition, we are amending §§ 405.1056(g) and 423.2056(g) to add language to specifically exempt remands that are issued under §§ 405.1056(d) and 423.2056(d) (on a review of a QIC's or IRE's dismissal of a request for reconsideration) from potential review by the Chief ALJ or designee. Finally, we are replacing “can only be provided by CMS, the IRE, and/or the Part D plan sponsor” in proposed § 423.2034(a)(1), which was a drafting error, with “can be provided only by CMS, the IRE, and/or the Part D plan sponsor,” for consistency with the definition in § 423.2034(a)(2).
As described below, we proposed a number of changes to §§ 405.1036 and 423.2036, which describe the ALJ hearing process, including the right to appear and present evidence, waiving the right to appear at the hearing, presenting written statements and oral arguments, waiver of the adjudication period, what evidence is admissible at the hearing, subpoenas, and witnesses at a hearing. 81 FR 43790, 43836-43837. Current § 405.1037 describes the discovery process in part 405, subpart I proceedings, which is permitted when CMS or a contractor elects to be a party to the ALJ hearing; there is no corresponding provision for part 423, subpart U proceedings because CMS, the IRE, and the Part D plan sponsor may not be made parties to the hearing.
Current § 405.1036(b)(1) states that a party may “send the ALJ” a written statement indicating that he or she does not wish to appear at the hearing. We proposed at § 405.1036(b)(1) to revise this provision to state that a party may “submit to OMHA” a written statement indicating that he or she does not wish to appear at the hearing. We stated in the proposed rule that while the written statement could still be sent to an ALJ who is assigned to a request for hearing, we proposed that the statement could be submitted to OMHA (for example, the statement could be submitted with the request for hearing), or to the ALJ or attorney adjudicator, as proposed in section II.B of the proposed rule (and discussed in section II.A.2 of this final rule above), after the request is assigned, to provide more flexibility and to accommodate situations where an ALJ or attorney adjudicator has not been assigned a request for hearing. We proposed at § 423.2036(b)(1) to adopt a corresponding revision for submitting a waiver of the right to appear in part 423, subpart U proceedings. In addition, we proposed at § 423.2036(b)(1)(ii) to revise the current requirement for the “ALJ hearing office” to document oral requests to require “OMHA” to document oral requests, to help ensure that applicability of the requirement is clear regardless of whether the oral request is received by an adjudicator in an OMHA field office after the appeal is assigned to an ALJ or attorney adjudicator, or the oral request is received in the OMHA central office before the appeal is assigned to an ALJ or attorney adjudicator.
As discussed in section III.A.3.h of the proposed rule and II.B.3.h of this final rule above, we proposed to move the provision for waiving the adjudication period from current § 405.1036(d) to proposed § 405.1016(d) because proposed § 405.1016 addresses adjudication time frames and we believe the section is a better place for discussing adjudication time frame waivers. To accommodate moving current § 405.1036(d) to proposed § 405.1016(d), we proposed to re-designate current § 405.1036(g), which describes witnesses at the hearing, as § 405.1036(d), because it more logically follows the discussion of presenting witnesses and oral arguments in current § 405.1036(c). For the same reasons, we proposed to move the provisions at § 423.2036(d) to § 423.2016(c), and proposed at § 423.2036(d) to re-designate current § 423.2036(g) as § 423.2036(d) to describe witnesses at a hearing in part 423, subpart U proceedings.
Current § 405.1036(f) discusses subpoenas. Current § 405.1036(f)(5)(i) states that an ALJ ruling on a subpoena request is not subject to immediate review by the Council and may be reviewed solely during the course of the Council's review specified in § 405.1102 (for requests for Council review when an ALJ issues a decision or dismissal), § 405.1104 (for requests for escalation to the Council), or § 405.1110 (for referrals for own motion review by the Council). As discussed in section III.A.3.h.ii of the proposed rule and II.B.3.h.ii of this final rule above, we proposed to remove section § 405.1104 and relocate provisions dealing with escalation to the Council to § 405.1016. Because the process for requesting escalation to the Council is now described in proposed § 405.1016(e) and (f), we proposed at § 405.1036(f)(5)(i) to replace the reference to § 405.1104 with a reference to § 405.1016(e) and (f). Current § 405.1036(f)(5)(ii) discusses CMS objections to a “discovery ruling” in the context of a paragraph on reviewability of subpoena rulings and current § 405.1037(e)(2)(i) separately addresses CMS objections to a discovery ruling. We proposed to revise § 405.1036(f)(5)(ii) to replace the current reference to a “discovery ruling” with “subpoena ruling” so it is consistent with the topic covered by § 405.1036(f). No corresponding revisions are necessary in § 423.2036(f) because there is no reference to a “discovery ruling.”
Current § 405.1037(a)(1) provides that discovery is permissible only when CMS or its contractors elects to participate in an ALJ hearing as a party. We stated in the proposed rule that, while the intent is generally clear, the use of “participate” is potentially confusing given that CMS or one of its contractors can elect to be a participant in the proceedings, including the hearing, in accordance with current and proposed § 405.1010, or elect to be a party to the hearing in accordance with current and proposed § 405.1012. We proposed to revise § 405.1037(a)(1) to state that discovery is permissible only when CMS or its contractor elects to be a party to an ALJ hearing, in accordance with proposed § 405.1012. As noted above, there are no provisions for discovery in part 423, subpart U proceedings because CMS, the IRE, or the Part D plan sponsor are not permitted to be a party to the hearing.
Current § 405.1037(e)(1) states that an ALJ discovery ruling or disclosure ruling is not subject to immediate review by the Council and may be reviewed solely during the course of the Council's review specified in § 405.1100 (for Council review in general), § 405.1102 (for requests for Council review when an ALJ issues a decision or dismissal), § 405.1104 (for requests for escalation to the Council), or § 405.1110 (for referrals for own motion review by the Council). For the reasons discussed above with regard to similar proposed changes in § 405.1036, we proposed at § 405.1037(e)(1) to replace the reference to § 405.1104 with a reference to § 405.1016(e) and (f).
Current § 405.1037(f) describes the effect of discovery on an adjudication time frame, and provides that the time frame is tolled until the discovery dispute is resolved. However, we stated in the propose rule that it does not clearly state when the effect on an adjudication time frame begins, and “discovery dispute” is not used elsewhere in the section. In addition, we stated that current § 405.1037(f) does not contemplate that an adjudication time frame may not apply (for example, when the adjudication time frame is waived in accordance with proposed § 405.1016(d)). Therefore, we proposed to revise § 405.1037(f) to state that if an adjudication period applies to the appeal in accordance with § 405.1016, and a party requests discovery from another party to the hearing, the adjudication period is extended for the duration of discovery, from the date a discovery request is granted until the date specified for ending discovery. We stated in the proposed rule that we believed this revision would provide a clearer standard for how an adjudication period is affected by discovery proceedings.
We received no comments on these proposals, other than comments discussed in section II.A.4 above related to our general proposal to reference OMHA or an OMHA office, in place of current references to an unspecified entity, ALJs, and ALJ hearing offices, when a reference to OMHA or an OMHA office provides a clearer explanation of a topic. Accordingly, for the reasons discussed above and in the proposed rule, we are finalizing the changes to §§ 405.1036, 405.1037, and 423.2036 as proposed without modification.
As described below, we proposed several changes to §§ 405.1038 and 423.2038, concerning when a case may be decided without a hearing before an ALJ. 81 FR 43790, 43837-43838. Current § 405.1038(a) provides authority to issue a “wholly favorable” decision without a hearing before an ALJ and without giving the parties prior notice when the evidence in the hearing record supports a finding in favor of the appellant(s) on every issue. We proposed in § 405.1038 that if the evidence in the administrative record supports a finding in favor of the appellant(s) on every issue and no other party to the appeal is liable for claims at issue, an ALJ or attorney adjudicator, as proposed in section II.B of the proposed rule (and discussed in section II.A.2 above), may issue a decision without giving the parties prior notice and without an ALJ conducting a hearing, unless CMS or a contractor has elected to be a party to the hearing in accordance with § 405.1012. Proposed § 405.1038(a) would replace “wholly favorable” with “fully favorable” in the subsection heading to align with language in § 405.1000(g), which addresses a fully favorable decision being made on the record, and the nomenclature used in OMHA's day to day operations. Proposed § 405.1038(a) would also replace “hearing record” with “administrative record” for consistency with other references to the record, and replace “hearing decision” with “decision,” for consistency with other references to a decision. We proposed at § 423.2038(a) to adopt corresponding revisions to align with language in § 423.2000(g) and to make references to the record and decisions consistent in part 423, subpart U proceedings.
Proposed § 405.1038(a) would also add two new limitations on issuing a decision without a hearing before an ALJ when the evidence in the administrative record supports a finding in favor of the appellant(s) on every
Current § 405.1038(b)(1) permits the ALJ to decide a case on the record and not conduct a hearing if: (1) All the parties indicate in writing that they do not wish to appear before the ALJ at a hearing, including a hearing conducted by telephone or video-teleconferencing, if available; or (2) an appellant lives outside of the United States and does not inform the ALJ that he or she wants to appear, and there are no other parties who wish to appear. We proposed to retain this structure in proposed § 405.1038(b) but did propose some changes. Current § 405.1038(b)(1)(i) requires all parties to indicate in writing that they do not wish to appear before the ALJ at a hearing, and as indicated above, current § 405.1038(b)(1)(ii) is contingent on no other parties wishing to appeal. However, the requirement to obtain a writing from all parties or determine the wishes of the non-appellant parties has limited the utility of the provisions. While all parties have a right to appear at the hearing, a notice of hearing is not sent to parties who did not participate in the reconsideration and were not found liable for the items or services at issue after the initial determination, in accordance with current § 405.1020(c). We proposed at § 405.1038(b)(1)(i) and (b)(1)(ii) to modify the requirements so writings only need to be obtained from, or wishes assessed from, parties who would be sent a notice of hearing, if a hearing were to be conducted. We stated that using the notice of hearing standard protects the interests of potentially liable parties, while making the provisions a more effective option for the efficient adjudication of appeals. In addition, proposed § 405.1038(b)(1) would reinforce that only an ALJ conducts a hearing by indicating an ALJ or attorney adjudicator may decide a case on the record without an ALJ conducting a hearing. Proposed § 405.1038(b)(1)(ii) also would indicate that an appellant who lives outside of the United States would inform “OMHA” rather than “the ALJ” that he or she wants to appear at a hearing before an ALJ, so an appellant could make that indication before an appeal is assigned to an ALJ or attorney adjudicator. We proposed at § 423.2038(b)(1) and (b)(1)(ii) to adopt corresponding revisions to reinforce that only an ALJ conducts a hearing and an enrollee who lives outside of the United States would inform OMHA that he or she wishes to appear at a hearing before an ALJ, but the other changes in proposed § 405.1038(b) were not proposed in § 423.2038(b) because only the enrollee is a party in part 423, subpart U proceedings. We also proposed in § 405.1038(b)(1)(i) to replace “videoteleconferencing,” and in § 423.2038(b)(1)(i) to replace “video teleconferencing,” with “video-teleconferencing,” for consistency with terminology used in §§ 405.1000, 405.1036, 423.2000, 423.2020, and 423.2036.
On occasion, CMS or one of its contractors indicates that it believes an item or service should be covered or payment made on an appealed claim, either before or at a hearing. However, there are no current provisions that address this circumstance, and we stated in the proposed rule that it is one that is ideal for a summary decision in favor of the parties based on the statement by CMS or its contractor, in lieu of a full decision that includes findings of fact, conclusions of law, and other decision requirements. We proposed to add § 405.1038(c) to provide a new authority for a stipulated decision, when CMS or one of its contractors submits a written statement or makes an oral statement at a hearing indicating the item or service should be covered or paid. In this situation, an ALJ or attorney adjudicator may issue a stipulated decision finding in favor of the appellant or other liable parties on the basis of the statement, and without making findings of fact, conclusions of law, or further explaining the reasons for the decision. We proposed at § 423.2038(c) to adopt a corresponding authority for stipulated decisions in part 423, subpart U proceedings.
Provided below are summaries of the specific comments received and responses to these comments:
If CMS or its contractor has properly elected to be a party, it has a right to appear at an ALJ hearing. As the claims payor, CMS and its contractors have an interest in the outcome of the case, similar to any other party to the appeal that is or may be liable for the claims at issue. Regardless of whether CMS's position may be apparent from the administrative record by the time an appeal reaches the OMHA level, CMS or a contractor that has properly elected party status has the right to present its
ALJs and attorney adjudicators will be subject to the same time frames for issuing a decision, dismissal, or remand, as discussed in section II.B.3.h above, including when decisions are issued under §§ 405.1038(b) and 423.2038(b) as finalized in this rule. However, we note that if all of the parties waive a hearing and a decision can be issued pursuant to § 405.1038(b) or § 423.2038(b) without conducting a hearing, the decision may be issued sooner than if a hearing were scheduled and conducted, regardless of whether an ALJ or attorney adjudicator issues the decision under § 405.1038(b) or § 423.2038(b). Scheduling a hearing requires the ALJ to determine an available hearing date and time and give the parties sufficient advance notice (at least 20 calendar days under § 405.1022(a) and for non-expedited Part D hearings under § 423.2022(a)). Sections 405.1020(e)(4) and 423.2020(e)(4) allow for hearings to be rescheduled if a party or the enrolle objects to the scheduled date and/or time and the ALJ finds good cause to reschedule the hearing, which could result in even longer delays. Appellants who wish to avoid the additional time it takes to schedule and conduct a hearing before a decision can be issued may choose to waive the hearing.
However, we agree that it would not be appropriate for an ALJ or attorney adjudicator to issue a stipulated decision when the amount of payment is specifically at issue before the ALJ or attorney adjudicator, if the statement from CMS or its contractor does not agree to the amount of payment the party believes should be made. If the amount of payment on a claim is at issue before the ALJ or attorney adjudicator, a general statement from CMS or its contractor that the item or service should be covered or payment may be made would not address the issue on appeal. We are therefore amending § 405.1038(c) to provide that if the amount of payment is an issue before the ALJ or attorney adjudicator, a stipulated decision may be made if the statement from CMS or its contractor agrees to the amount of payment the party believes should be made. We are making a corresponding change to § 423.2038(c) for stipulated decisions in part 423, subpart U proceedings.
After review and consideration of the comments received, for the reasons discussed above and in the proposed rule, we are finalizing the changes to §§ 405.1038 and 423.2038 as proposed with the following modification. We are amending §§ 405.1038(c) and 423.2038(c) to provide that if the amount of payment is an issue before an ALJ or attorney adjudicator, the statement upon which a stipulated decision is based must agree to the amount of payment the parties believe should be made.
As described below, we proposed a number of changes to §§ 405.1040 and 423.2040 with respect to prehearing and posthearing conferences. 81 FR 43790, 43838-43839. Current § 405.1040 discusses prehearing and posthearing conferences and permits the ALJ to hold these conferences to facilitate the hearing or hearing decision. Current § 405.1040(b) requires an ALJ to inform “the parties” of the time, place, and purpose of the prehearing or posthearing conference, unless a party indicates in writing that it does not wish to receive a written notice of the conference. In accordance with current § 405.1020(c), the notice of hearing is not sent to a party who did not participate in the reconsideration and was not found liable for the services at issue after the initial determination. Therefore, we proposed to modify § 405.1040(b) to state that the ALJ would inform parties who would be or were sent a notice of hearing in accordance with § 405.1020(c). In addition, current § 405.1040(b) does not provide for conference notice to be sent to CMS or a contractor that elected to be a participant in the proceedings or a party to the hearing at the time the conference notice is sent, which has caused confusion when CMS or a contractor has made an election before or after a conference. Therefore, we proposed at § 405.1040(b) that a conference notice be sent to CMS or a contractor that has elected to be a participant in the proceedings or a party to the hearing at the time the conference notice is sent. We stated in the proposed rule that we believed these changes would help ensure the appropriate parties and participants are provided with notice of, and have an opportunity to attend, a conference. We proposed at § 423.2040(b) and (c) to adopt corresponding revisions for prehearing conference notices in non-expedited and expedited hearings respectively to state that a conference notice is sent to CMS, the IRE, and/or the Part D plan sponsor if the ALJ has granted their request(s) to be a participant in the hearing, but we did not propose to make other changes in proposed § 405.1040(b) to § 423.2040 because only the enrollee is a party in part 423, subpart U proceedings. In addition, because an oral request not to receive a notice of the conference is permitted for expedited hearings, we proposed at § 423.2040(d) to revise the requirement for an “ALJ hearing office” to document such an oral request to provide more generally that oral requests must be documented,
Current § 405.1040(c) states that, at the conference, the ALJ may consider matters in addition to those stated in the notice of hearing, if the parties consent in writing. However, OMHA ALJs have indicated that providing them with the discretion to delegate conducting a conference to an attorney would add efficiency to the process. OMHA attorneys are licensed attorneys who support ALJs in evaluating appeals and preparing appeals for hearing, as well as drafting decisions, and are well versed in Medicare coverage and payment policy, as well as administrative procedure. Therefore, we proposed at § 405.1040(c)(1) that, at the conference, the ALJ or an OMHA attorney designated by the ALJ may conduct the conference, but only the ALJ conducting a conference may consider matters in addition to those stated in the conference notice if the parties consent to consideration of the additional matters in writing. We stated in the proposed rule that this revision would allow an OMHA attorney designated by the ALJ assigned to an appeal to conduct a conference, but would only allow an ALJ conducting the conference to consider matters in addition to those stated in the conference notice. We stated that we believe allowing ALJs to delegate the task of conducting a conference (consistent with the conference notice stating the purpose of the conference, in accordance with § 405.1040(b)) would provide ALJs with the flexibility to use OMHA attorneys and provide ALJs with more time to devote to hearings and decisions. We also stated that we believe using attorneys to conduct conferences is appropriate because conferences are informal proceedings to facilitate a hearing or decision, and do not involve taking testimony or receiving evidence, both of which occur at the hearing. We also noted that the results of the conference embodied in a conference order are subject to review and approval by the ALJ, and ultimately subject to an objection by the parties, under the provisions of current § 405.1040, which are carried over in proposed § 405.1040. We proposed at § 423.2040(e)(1) to adopt corresponding revisions for allowing an ALJ to delegate conducting a conference to an OMHA attorney in part 423, subpart U proceedings.
Current § 405.1040(c) references the notice of hearing in discussing the matters that are considered at a conference. However, a notice of hearing may not have been issued at the time a prehearing conference is scheduled, and the matters being addressed in the appeal may have evolved since a notice of hearing was issued by the time a posthearing conference is scheduled, resulting in confusion on the permissible scope of the matters discussed at a conference. Therefore, § 405.1040(c)(1) would state that the matters that are considered at a conference are those stated in the conference notice (that is, the purpose of the conference, as discussed in current § 405.1040(b)).
Current § 405.1040(c) states that a record of the conference is made. However, that requirement has been read and applied differently by adjudicators. We proposed at § 405.1040(c)(2) to require that an audio recording of the conference be made to establish a consistent standard and because the audio recording is the most administratively efficient way to make a record of the conference. We proposed at § 423.2040(e)(1) and (e)(2) to adopt corresponding revisions to reference a conference notice and clarify that an audio recording of the conference is made in part 423, subpart U proceedings.
Current § 405.1040(d) requires the ALJ to issue an order stating all agreements and actions resulting from the conference. If the parties do not object, the agreements and actions become part of the hearing record and are binding on all parties. It does not state to whom a conference order is issued, and again broadly references parties in indicating who may object to the order. In addition, current § 405.1040(d) does not establish a time period within which an objection must be made before the order becomes part of the record and binding on the parties. Therefore, we proposed to revise § 405.1040(d) to state that the ALJ issues an order to all parties and participants who attended the conference stating all agreements and actions resulting from the conference. We proposed that if a party does not object within 10 calendar days of receiving the order, or any additional time granted by the ALJ, the agreements and actions become part of the administrative record and are binding on all parties. Proposed § 405.1040(d) would provide that the order is issued to the parties and participants who attended the conference to help ensure the appropriate parties and participants receive the order, but as in current § 405.1040(d), only a party could object to the order. Proposed § 405.1040(d) would also establish that an objection must be made within 10 calendar days of receiving the order to establish a consistent minimum standard for making an objection to a conference order, but would also provide the ALJ with the discretion to grant additional time. In addition, proposed § 405.1040(d) would replace “hearing record” with “administrative record” for consistency with other references to the record. Further, proposed § 405.1040(d) would continue to only allow the ALJ to issue a conference order, because we believe the ALJ should review and approve the actions and agreements resulting from the conference, and only an ALJ should issue an order that would be binding on the parties, if no objection is made. We proposed at § 423.2040(f) to adopt corresponding revisions to clarify to whom a conference order is sent and the time frame to object to the order, and to specify that agreements and actions resulting from the conference become part of the “administrative record” (rather than “hearing record”) in part 423, subpart U proceedings. However, we proposed to add that an enrollee must object to a conference order within 1 calendar day of receiving the order for expedited hearings because of the abbreviated time frame under which an expedited hearing and decision must be completed.
Provided below are summaries of the specific comments received and responses to these comments:
After review and consideration of the comments received, for the reasons discussed above and in the proposed rule, we are finalizing the changes to §§ 405.1040 and 423.2040 as proposed without modification.
The administrative record is HHS's record of the administrative proceedings, and is initially established by OMHA ALJs and built from the records of CMS contractors that adjudicated the claim, or from records maintained by SSA in certain circumstances. After adjudication by OMHA, the Council may include more documents in the administrative record, if a request for Council review is filed or a referral to the Council is made. If a party then seeks judicial review, the administrative record is certified and presented to the Court as the official agency record of the administrative proceedings. The record is returned to the custody of CMS contractors or SSA after any administrative and judicial review is complete. We stated in the proposed rule that current practices in creating the administrative record in accordance with current §§ 405.1042 and 423.2042 vary widely. Given the importance of the administrative record, we proposed to revise §§ 405.1042 and 423.2042 to provide for more consistency and to clarify its contents and other administrative matters. 81 FR 43790, 43839-43841.
Current § 405.1042(a)(1) provides that the ALJ makes a complete record of the evidence, including the hearing proceedings, if any. However, we stated in the proposed rule that this provision has been limiting and causes confusion in developing procedures to ensure the completeness of the record and in bringing consistency to how the record is structured because individual adjudicators organize the record differently. We proposed to revise § 405.1042(a)(1) to require OMHA to make a complete record of the evidence and administrative proceedings on the appealed matter, including any prehearing and posthearing conferences, and hearing proceedings that were conducted. Proposed § 405.1042(a)(1) would vest OMHA, rather than the ALJ, with the responsibility of making a complete record of the evidence and administrative proceedings in the appealed matter, including any prehearing and posthearing conferences and hearing proceedings. We stated that this would provide OMHA with more discretion to develop polices and uniform procedures for constructing the administrative record, while preserving the role of the ALJ or attorney adjudicator, as proposed in section II.B of the proposed rule (and discussed in section II.A.2 of this final rule above), to identify the evidence that was used in making the determinations below and the evidence that was used in making his or her decision. We proposed at § 423.2042(a)(1) to also adopt corresponding revisions to indicate OMHA makes a complete record of the evidence and administrative proceedings in the appealed matter in part 423, subpart U proceedings.
Current § 405.1042(a)(2) discusses which documents in the record are marked as exhibits, and provides a non-exhaustive list of documents that are marked to indicate that they were considered in making the decisions under review or the ALJ's decision. It further states that in the record, the ALJ also must discuss any evidence excluded under § 405.1028 and include a justification for excluding the evidence. We proposed to revise § 405.1042(a)(2) to state that the record would include marked as exhibits, the appealed determinations, and documents and other evidence used in making the appealed determinations and the ALJ's or attorney adjudicator's decision, including, but not limited to, claims, medical records, written statements, certificates, reports, affidavits, and any other evidence the ALJ or attorney admits. We proposed that attorney adjudicators could mark exhibits because as proposed in section II.B of the proposed rule (and discussed in section II.A.2 of this final rule above), attorney adjudicators would be adjudicating requests for hearing and requests for review of a QIC dismissal,
As stated previously, current § 405.1042(a)(2) includes requirements to discuss any evidence excluded under current § 405.1028 and include a justification for excluding the evidence. We proposed in § 405.1042(a)(2) to remove these requirements. We stated in the proposed rule that we believed the requirement to justify excluding the evidence is not necessary and is in tension with the requirement for a provider or supplier, or beneficiary represented by a provider or supplier, to establish good cause for submitting new evidence before it may be considered. Section 1869(b)(3) of the Act establishes a general prohibition on new evidence that must be overcome, and proposed § 405.1028 would implement the statute by requiring the party to explain why the evidence was not submitted prior to the QIC reconsideration, and the ALJ or attorney adjudicator to make a finding of good cause to admit the evidence. In place of the current § 405.1042(a)(2) requirement, as we discuss later, we proposed at § 405.1046(a)(2)(ii) to require that if new evidence is submitted for the first time at the OMHA level and subject to a good cause determination pursuant to proposed § 405.1028, the new evidence and good cause determination would be discussed in the decision. We also stated in the proposed rule that we believed the decision is the appropriate place to discuss the new evidence and document the good cause determination, and the discussion should focus on the good cause determination required by proposed § 405.1028, regardless of whether good cause was found. We did not propose any corresponding changes to § 423.2042 because there is no provision equivalent to the current § 405.1042(a)(2) requirement to discuss any excluded evidence.
Current § 405.1042(a)(3) provides that a party may review the record “at the hearing,” or if a hearing is not held, at any time before the ALJ's notice of decision is issued. However, this is rarely done in practice. More often, a party requests a copy of the record prior to the hearing, in accordance with current § 405.1042(b). We proposed to revise § 405.1042(a)(3) to state that a party may request and review the record prior to or at the hearing, or if a hearing is not held, at any time before the notice of decision is issued. This revision would allow a party to request and review a copy of the record “prior to or at the hearing” to more accurately reflect the practices of parties. In addition, proposed § 405.1042(a)(3) would remove the reference to an “ALJ's” decision in explaining that if a hearing is not held, a party may request and review the record at any time before the notice of decision is issued, because in that circumstance an ALJ or attorney adjudicator, as proposed in section II.B of the proposed rule (and discussed in section II.A.2 of this final rule above), may issue the decision. We proposed at § 423.2042(a)(3) to adopt corresponding revisions for part 423, subpart U proceedings.
Current § 405.1042(a)(4) provides for the complete record, including any recording of the hearing, to be forwarded to the Council when a request for review is filed or the case is escalated to the Council. However, in noting that the record includes recordings, only a recording of the hearing is mentioned. We proposed at § 405.1042(a)(4) to add that the record includes recordings of prehearing and posthearing conferences in addition to the hearing recordings, to reinforce that recordings of conferences are part of the complete record. We proposed at § 423.2042(a)(4) to adopt corresponding revisions for part 423, subpart U proceedings.
Current § 405.1042(b)(1) describes how a party may request and receive copies of the record from the ALJ. However, after a case is adjudicated, OMHA releases custody of the record and forwards it to a CMS contractor or SSA, and the record may go on to the Council for another administrative proceeding. We stated in the proposed rule that this results in confusion for parties when they request a copy of the record and OMHA is unable to provide it. We proposed at § 405.1042(b)(1) that a party may request and receive a copy of the record from OMHA while an appeal is pending at OMHA. We also proposed at § 405.1042(b)(1) to replace the reference to an “exhibit list” with a reference to “any index of the administrative record” to provide greater flexibility in developing a consistent structure for the administrative record. We also proposed to change the parallel reference to “the exhibits list” in § 405.1118 to “any index of the administrative record.” In addition, proposed § 405.1042(b)(1) would replace the reference to a “tape” of the oral proceeding with an “audio recording” of the oral proceeding because tapes are no longer used and a more general reference would accommodate future changes in recording formats. We also proposed to replace a parallel reference at § 405.1118 to a copy of the “tape” of the oral proceedings with a copy of the “audio recording” of the oral proceedings. We proposed at §§ 423.2042(b)(1) and 423.2118 to adopt corresponding revisions for part 423, subpart U proceedings, but note that current § 423.2118 refers to a “CD” of the oral proceedings.
Current § 405.1042(b)(2) provides that if a party requests all or part of the record from an ALJ and an opportunity
Current § 405.1042 does not address the circumstance in which a party requests a copy of the record but is not entitled to receive some of the documents in the record. For example, when an appeal involves multiple beneficiaries and one beneficiary requests a copy of the record, the records related to other beneficiaries may not be released to the requesting beneficiary unless he or she obtains consent from the other beneficiaries to release the records that pertain to them. Proposed § 405.1042(b)(3) would address the possibility that a party requesting a copy of the record is not entitled to receive the entire record. Specifically, we proposed in § 405.1042(b)(3) that if a party requests a copy of all or part of the record and the record, including any audio recordings, contains information pertaining to an individual that the requesting party is not entitled to receive (for example, personally identifiable information or protected health information), those portions of the record would not be furnished unless the requesting party obtains consent from the individual. For example, if a beneficiary requests a copy of the record for an appeal involving multiple beneficiaries, the portions of the record pertaining to the other beneficiaries would not be furnished to the requesting beneficiary unless he or she obtains consent from the other beneficiaries. We stated in the proposed rule that we believed proposed § 405.1042(b)(3) would help ensure that parties are aware that they may not be entitled to receive all portions of the record. We proposed at § 423.2042(b)(3) to adopt corresponding revisions for part 423, subpart U proceedings.
Provided below are summaries of the specific comments received and responses to these comments:
With respect to the commenter's second suggestion, as discussed in section II.B.3.i above, we are amending the language in § 405.1018(d) to clarify that the limitation on submitting new evidence for the first time at the OMHA level (as set forth in § 405.1018(c)) does not apply to evidence submitted by an unrepresented beneficiary, CMS or its contractors, a Medicaid State agency, an applicable plan, or a beneficiary represented by someone other than a provider or supplier.
We do not agree with the commenters that the regulations are the appropriate place for specific agency instructions on creating the index of the administrative record. OMHA is in the process of developing the OCPM, a reference guide outlining the day-to-day operating instructions, policies, and procedures of the agency. The OCPM describes OMHA case processing procedures in greater detail than generally is included in regulation and provides frequent examples to aid understanding. This resource, which is available to the public on the OMHA Web site (
We are also not adopting the commenter's recommendation that OMHA send the exhibit list to all the parties seven days prior to the hearing. The OCPM already requires that an initial copy of the exhibit list be provided with the notice of hearing to the parties and potential parties and participants who receive the notice, or at the first available opportunity before the hearing to the parties and potential parties and participants who responded to the notice of hearing. Under §§ 405.1022(a)(1) and 423.2022(a)(2), as finalized in this rule, the notice of hearing is mailed, transmitted, or served at least 20 calendar days before the hearing (except for expedited part D hearings, where notice is mailed, transmitted, or served at least 3 calendar days before the hearing), unless a party or participant agrees to fewer than 20 calendar days' or 3 calendar days' notice, as applicable. Therefore, the OCPM already requires that parties and potential parties and participants receive the exhibit list earlier than the commenter's recommendation of seven days prior to the hearing, or at the first available opportunity. (After the effective date of this final rule, we anticipate that revisions will be made to the OCPM to refer to an index of the administrative record, rather than an exhibit list.) In addition, proposed §§ 405.1042(b)(1) and 423.2042(b)(1) state that at any time while an appeal is pending at OMHA, a party may request and receive a copy of all or part of the record, including a copy of the index of the administrative record. Finally, with regard to the second comment, we believe that if the exhibit lists are consistent across adjudicators, there will be improved clarity as to the types of documents within the specific exhibit categories. While it is not administratively possible given OMHA's docket and staffing constraints to create exhaustive lists of each document or item on an exhibit list, the implementation of uniform exhibiting procedures by OMHA, including the use of consistent exhibit categories, should make it easier for parties who only require certain documents or portions of a record to determine which exhibit number to request.
After review and consideration of the comments received, for the reasons discussed above and in the proposed rule, we are finalizing the changes to §§ 405.1042 and 423.2042 as proposed without modification.
Current §§ 405.1044 and 423.2044 explain that a consolidated hearing may be held at the request of an appellant or on the ALJ's own motion, if one or more of the issues to be considered at the hearing are the same issues that are involved in another request for hearing or hearings pending before the same ALJ, and CMS is notified of an ALJ's
Current § 405.1044 uses the terms “requests for hearing,” “cases,” and “claims” interchangeably, and we stated in the proposed rule that this has resulted in confusion because an appeal, or “case,” before an ALJ may involve multiple requests for hearing if an appellant's requests were combined into one appeal for administrative efficiency prior to being assigned to the ALJ. In addition, a request for hearing may involve one or more claims. We proposed in § 405.1044 to use the term “appeal” to specify that appeals may be consolidated for hearing, and a single decision and record may be made for consolidated appeals. We proposed to use “appeal” because an appeal is assigned a unique ALJ appeal number, for which a unique decision and record is made. We also proposed to move current § 405.1044(b) to new subsection (a)(2), and to also replace the term “combined” with “consolidated” for consistent use in terminology. Further, we proposed at § 423.2044 to adopt corresponding revisions to use consistent terminology in part 423, subpart U proceedings.
Current § 405.1044(a) through (d) describes when a consolidated hearing may be conducted, the effect on an adjudication period that applies to the appeal, and providing notice of the consolidated hearing to CMS. Proposed § 405.1044(a) would incorporate current § 405.1044(a) through (c) to combine the provisions related to a consolidated hearing. In addition, proposed § 405.1044(a)(4) would replace the current requirement to notify CMS that a consolidated hearing will be conducted in current § 405.1044(d) with a requirement to include notice of the consolidated hearing in the notice of hearing issued in accordance with §§ 405.1020 and 405.1022. We stated that this would help ensure notice is provided to the parties and CMS, as well as its contractors, in a consistent manner, and reduce administrative burden on ALJs and their staff by combining that notice into the existing notice of hearing. We proposed at § 423.2044(a) to adopt corresponding revisions for part 423, subpart U proceedings.
Current § 405.1044(e) explains that when a consolidated hearing is conducted, the ALJ may consolidate the record and issue a consolidated decision, or the ALJ may maintain separate records and issue separate decisions on each claim. It also states that the ALJ ensures that any evidence that is common to all claims and material to the common issue to be decided is included in the consolidated record or each individual record, as applicable. However, there has been confusion on whether separate records may be maintained and a consolidated decision can be issued, as well as what must be included with the records when separate records are maintained. Proposed § 405.1044(b) would incorporate some of current § 405.1044(e) and add provisions for making a consolidated record and decision. We proposed at § 405.1044(b)(1) that if the ALJ decides to hold a consolidated hearing, he or she may make either a consolidated decision and record, or a separate decision and record on each appeal. This proposed revision would maintain the current option to make a consolidated record and decision, or maintain separate records and issue separate decisions, but restructures the provision to highlight that these are two mutually exclusive options. This proposal is important because issuing a consolidated decision without also consolidating the record, or issuing separate decisions when a record has been consolidated, complicates effectuating a decision and further reviews of the appeal(s). We proposed in § 405.1044(b)(2) that, if a separate decision and record on each appeal is made, the ALJ is responsible for making sure that any evidence that is common to all appeals and material to the common issue to be decided, and audio recordings of any conferences that were conducted and the consolidated hearing, are included in each individual administrative record. We stated that proposed § 405.1044(b)(2) would address the confusion that sometimes results in a copy of the audio recording of a consolidated hearing not being included in the administrative records of each constituent appeal when separate records are maintained, by clarifying that if a separate decision and record is made, audio recordings of any conferences that were conducted and the consolidated hearing are included in each individual record. We stated that this proposal is important because the record for each individual appeal must be complete. We proposed at § 423.2044(b)(1) and (b)(2) to adopt corresponding revisions for part 423, subpart U proceedings.
Current § 405.1044 does not contemplate a consolidated record and decision unless a consolidated hearing was conducted, which is limiting when multiple appeals for an appellant can be consolidated in a decision issued on the record without a hearing. We proposed to add § 405.1044(b)(3), which would provide that, if a hearing would not be conducted for multiple appeals that are before the same ALJ or attorney adjudicator as proposed in section II.B of the proposed rule (and discussed in section II.A.2 above), and the appeals involve one or more of the same issues, the ALJ or attorney adjudicator may make a consolidated decision and record at the request of the appellant or on the ALJ's or attorney adjudicator's own motion. We stated that this would provide authority for an ALJ or attorney adjudicator to make a consolidated decision and record on the same basis that a consolidated hearing may be conducted. We stated in the proposed rule that we believed this authority would add efficiency to the adjudication process when multiple appeals pending before the same adjudicator can be decided without conducting a hearing. We proposed at § 423.2044(b)(3) to adopt a corresponding provision for part 423, subpart U proceedings.
Current § 405.1044 also does not clearly address consolidating hearings for multiple appellants, including situations in which a beneficiary files a request for hearing on the same claim appealed by a provider or supplier, and the provider or supplier has other pending appeals that could be consolidated pursuant to current § 405.1044. We stated that the general practice is that a consolidated hearing is conducted for the appeals of a single appellant. This is supported by the reference to “an” appellant in current § 405.1044(b), and helps ensure the hearing and record is limited to protected information that the appellant is authorized to receive. Therefore, we proposed to add § 405.1044(c) to provide that consolidated proceedings may only be conducted for appeals filed by the same appellant, unless multiple appellants aggregated claims to meet the
Provided below are summaries of the specific comments received and responses to these comments:
Although there may be rare and unusual circumstances where it may be permissible to release the protected health information of an individual to other parties (for example, a court order expressly authorizing such disclosure to litigants), we do not believe there are any generally applicable exceptions to the HIPAA privacy rules that would apply or be appropriate in this case to permit the consolidation of proceedings involving multiple appellants where the appellants are unable to obtain authorization from the beneficiaries whose claims are at issue to disclose their protected information to the other parties and any participants. Consolidation of proceedings where multiple appellants are involved may result in disclosure of an individual's protected health information to other individuals, including other involved beneficiaries, who do not have a right to receive the information and have no use for the information.
After review and consideration of the comments received, for the reasons discussed above and in the proposed rule, we are finalizing the changes to §§ 405.1044 and 423.2044 as proposed without modification.
Current §§ 405.1046 and 423.2046 describe the requirements for a decision and providing notice of the decision, the content of the notice, the limitation on a decision that addresses the amount of payment for an item or a service, the timing of the decision, and recommended decisions. Current §§ 405.1048 and 423.2048 describe the effects of an ALJ's decision. However, the current sections only apply to a decision on a request for hearing, leaving ambiguities when issuing a decision on a request for review of a QIC or IRE dismissal. We proposed to consolidate the provisions of each section that apply to a decision on a request for hearing under proposed §§ 405.1046(a), 405.1048(a), 423.2046(a) and 423.2048(a), with further revisions discussed below, and introduce new §§ 405.1046(b), 405.1048(b), 423.2046(b) and 423.2048(b) to address a decision on a request for review of a QIC or IRE dismissal, as well as to revise the titles and provisions of the sections to expand their coverage to include decisions by attorney adjudicators, as proposed in section II.B of the proposed rule (and discussed in section II.A.2 above). We also proposed to remove current § 405.1046(d), which addresses the timing of a decision on a request for hearing because it is redundant with § 405.1016 and could lead to confusion if a different adjudication period applies, such as a 180-calendar day period for an escalated request for QIC reconsideration, or if no adjudication period applies, such as when the period is waived by the appellant. Similarly, we proposed to remove current §§ 423.2046(a)(1) and (d) because the adjudication time frames discussed in the provisions are redundant with provisions in proposed § 423.2016. In addition, we proposed to re-designate current §§ 405.1046(e) and 423.2046(e), as proposed §§ 405.1046(c) and 423.2046(c) respectively, to reflect the revised structure of proposed §§ 405.1046 and 423.2046. 81 FR 43790, 43842-43843.
Current § 405.1046 states that an ALJ will issue a decision unless a request for hearing is dismissed. We proposed to revise § 405.1046(a) to state that an ALJ or attorney adjudicator would issue a decision unless the request for hearing is dismissed or remanded in order to accommodate those situations where the ALJ or attorney adjudicator remands a case to the QIC. We stated in the proposed rule that there has been confusion regarding the content requirements of the decision itself, as well as whether the findings or conclusions in a QIC reconsideration or the arguments of the parties may be referenced or adopted in the decision by reference. We stated that we believe that while the issues that are addressed in a decision are guided by the reconsideration, as well as the initial determination and redetermination, and a party may present arguments in a framework that reflects recommended findings and conclusions, the concept of a de novo review requires an ALJ or attorney adjudicator to make independent findings and conclusions. To address this confusion, we proposed in § 405.1046(a) to require that the decision include independent findings and conclusions to clarify that the ALJ or attorney adjudicator must make independent findings and conclusions, and may not merely incorporate the findings and conclusions offered by others, though the ALJ or attorney adjudicator may ultimately make the same findings and conclusions. As discussed in and for the reasons stated in section III.A.3.t of the proposed rule and II.B.3.t of this final rule above, proposed § 405.1046(a)(2)(ii) would also require that if new evidence was submitted for the first time at the
Current § 405.1046(a) requires that a decision be mailed. As OMHA transitions to a fully electronic case processing and adjudication environment, new options for transmitting a decision to the parties and CMS contractors may become available, such as through secure portals for parties or through inter-system transfers for CMS contractors. We proposed in § 405.1046(a) to revise the requirement that a decision be mailed to state that OMHA “mails or otherwise transmits a copy of the decision,” to allow for additional options to transmit the decision as technologies develop. We proposed to revise § 423.2046(a) to adopt a corresponding revision for sending a decision under part 423, subpart U.
Current § 405.1046(a) also requires that a copy of the decision be sent to the QIC that issued the reconsideration. However, if the decision is issued pursuant to escalation of a request for a reconsideration, no reconsideration was issued. To address this circumstance, we proposed in § 405.1046(a) that the decision would be issued to the QIC that issued the reconsideration or from which the appeal was escalated. In addition, we proposed in § 405.1046(a) to replace “reconsideration determination” with “reconsideration” for consistency in referencing the QIC's action. Current § 405.1046(a) also requires that a copy of the decision be sent to the contractor that made the initial determination. However, this requirement adds to the administrative burden on OMHA and we stated in the proposed rule we believed it was unnecessary in light of the requirement that a copy of the decision be sent to the QIC and the original decision is forwarded as part of the administrative record to another CMS contractor to effectuate the decision. Thus, we proposed in § 405.1046(a) to remove the requirement to send a copy of the decision to the contractor that issued the initial determination. In addition, we proposed in § 423.2046(a) to replace “reconsideration determination” with “reconsideration” for consistency in referencing the IRE's action in part 423, subpart U proceedings, but we did not propose to incorporate other changes proposed for § 405.1046(a) in proposed § 423.2046(a) because: (1) Escalation is not available in part 423, subpart U proceedings; and (2) the Part D plan sponsor, which makes the initial coverage determination, has an interest in receiving and reviewing ALJ and attorney adjudicator decisions related to an enrollee's appeal of drug coverage.
As discussed above, we proposed to revise § 405.1046(b) to explain the process for making a decision on a request for review of a QIC dismissal. In accordance with proposed § 405.1004, we proposed in § 405.1046(b)(1) that unless the ALJ or attorney adjudicator dismisses the request for review of a QIC's dismissal or the QIC's dismissal is vacated and remanded, the ALJ or attorney adjudicator issues a written decision affirming the QIC's dismissal. We proposed in § 405.1046(b)(1) that OMHA would mail or otherwise transmit a copy of the decision to all the parties that received a copy of the QIC's dismissal because, as we stated in the proposed rule, we believe that the QIC would appropriately identify the parties who have an interest in the dismissal, and that notice of the decision on a request for review of a QIC dismissal to any additional parties is unnecessary. We also stated that we believe that notice to the QIC is not necessary when its dismissal is affirmed because it has no further obligation to take action on the request for reconsideration that it dismissed. We proposed in § 405.1046(b)(2)(i) that the decision affirming a QIC dismissal must describe the specific reasons for the determination, including a summary of the evidence considered and applicable authorities, but did not propose to require a summary of clinical or scientific evidence because such evidence is not used in making a decision on a request for a review of a QIC dismissal. In addition, we proposed that § 405.1046(b)(2)(ii) and (iii) would explain that the notice of decision would describe the procedures for obtaining additional information concerning the decision, and would provide notification that the decision is binding and not subject to further review unless the decision is reopened and revised by the ALJ or attorney adjudicator. We proposed to revise § 423.2046(b) to adopt corresponding provisions for a decision on requests for review of an IRE dismissal under part 423, subpart U, except that the notice of decision will only be sent to the enrollee because only the enrollee is a party.
We proposed to revise the title of current § 405.1048 to read “The effect of an ALJ's or attorney adjudicator's decision” and to replace the current introductory statement in § 405.1048(a) that “The decision of the ALJ is binding on all parties to the hearing” with “The decision of the ALJ or attorney adjudicator is binding on all parties” to make the subsection applicable to decisions by attorney adjudicators and because the parties are parties to the decision regardless of whether a hearing was conducted. We also proposed in § 405.1048(b) that the decision of the ALJ or attorney adjudicator on a request for review of a QIC dismissal is binding on all parties unless the decision is reopened and revised by the ALJ or attorney adjudicator under the procedures explained in § 405.980. We proposed to revise § 423.2048 to adopt corresponding provisions for the effects of ALJ and attorney adjudicator decisions under part 423, subpart U.
Provided below are summaries of the specific comments received and responses to these comments:
With respect to sending a copy of the decision to the contractor that made the initial determination, as stated above and in the proposed rule, we believe that sending the ALJ's or attorney adjudicator's decision to a CMS contractor to effectuate the decision and a copy to the QIC will be sufficient to inform CMS and its contractors of the decision. We believe that in the majority of cases the benefit of sending an additional copy to the contractor that made the initial determination is outweighed by the administrative burden and costs, and CMS is in the best position to determine how decisions are shared among its contractors and whether or how those decisions should be used by its contractors.
With respect to the commenter's suggestion to include instructions on how to obtain a copy of the administrative record in a notice of decision, we note that §§ 405.1046(a)(2)(iii), (b)(2)(ii), 423.2046(a)(2)(ii), and (b)(2)(ii), as finalized, require that a notice of decision must include the procedures for obtaining additional information concerning the decision, which would include information on how to obtain a copy of the administrative record. As discussed in section II.B.3.t of this final rule above, after a case is adjudicated, OMHA releases custody of the administrative record and forwards it to a CMS contractor or SSA. We will explore the possibility of adding contact information for the CMS contractor or SSA to the notice of decision; however, we believe that this would best be managed through internal policy at OMHA and not as part of this final rule.
After review and consideration of the comments received, for the reasons discussed above and in the proposed rule, we are finalizing the changes to §§ 405.1046, 405.1048, 423.2046, and 423.2048 as proposed without modification.
Current §§ 405.1050 and 423.2050 explain the process for the Council to assume responsibility for holding a hearing if a request for hearing is pending before an ALJ. We proposed to replace “an ALJ” with “OMHA” in the section title, and to replace “pending before an ALJ” with “pending before OMHA,” and “the ALJ send” with “OMHA send” in the section text. In accordance with section II.B of the proposed rule and II.A.2 of this final rule above, these proposed revisions would provide that a request for hearing may be removed to the Council regardless of whether the request is pending before an ALJ or an attorney adjudicator. We did not propose to replace the last instance of “ALJ” in the section text because it refers specifically to hearings conducted by an ALJ. 81 FR 43790, 43843.
We received no comments on these proposals, other than: (1) Comments discussed in section II.A.2 of this final rule above related to our general proposals to provide authority for attorney adjudicators to issue certain decisions, dismissals and remands, and to revise the rules so that decisions and dismissals issued by attorney adjudicators may be reopened and/or
Current §§ 405.1052 and 423.2052 describe the circumstances in which a request for hearing may be dismissed and the requirements for a notice of dismissal, and current §§ 405.1054 and 423.2054 describe the effect of a dismissal of a request for hearing. However, both current sections apply to a dismissal of a request for hearing, leaving ambiguities when issuing a dismissal of a request for review of a QIC or IRE dismissal. We proposed to maintain the provisions of each section that apply to a dismissal of a request for hearing in proposed §§ 405.1052(a), 405.1054(a), 423.2052(a) and 423.2054(a), with further revisions discussed below. 81 FR 43790, 43843-43845. We proposed to introduce new §§ 405.1052(b), 405.1054(b), 423.2052(b) and 423.2054(b) to address a dismissal of a request for review of a QIC or IRE dismissal. However, we proposed to re-designate and revise §§ 405.1052(a)(1) and 423.2052(a)(1), as discussed below, and re-designate the remaining paragraphs in §§ 405.1052(a) and 423.2052(a) accordingly. We also proposed to remove the introductory language to current §§ 405.1052 and 423.2052 because it is unnecessary to state that a dismissal of a request for hearing is in accordance with the provisions of the section, as the provisions are themselves binding authority and state in full when a request for hearing may be dismissed. In addition, we proposed to revise the titles of the sections to expand their coverage to include dismissals of requests to review a QIC or IRE dismissal. Furthermore, we proposed to re-designate and revise current §§ 405.1052(b) and 423.2052(b), which describe notices of dismissal, as proposed §§ 405.1052(d) and 423.2052(d) respectively, to reflect the revised structure of proposed §§ 405.1052 and 423.2052. We also proposed to remove current § 423.2052(a)(8) and (c) because current § 423.2052(a)(8) restates current § 423.1972(c)(1), which already provides that a request for hearing will be dismissed if the request itself shows that the amount in controversy is not met, and current § 423.2052(c) restates current § 423.1972(c)(2), which already provides that if after a hearing is initiated, the ALJ finds that the amount in controversy is not met, the ALJ discontinues the hearing and does not rule on the substantive issues raised in the appeal. We noted that a dismissal would be warranted in these circumstances pursuant to current § 423.2052(a)(3), which is carried over as proposed § 423.2052(a)(2) because the enrollee does not have a right to a hearing if the amount in controversy is not met.
We proposed to re-designate and revise current §§ 405.1052(a)(1) and 423.2052(a)(1) as proposed §§ 405.1052(c) and 423.2052(c) to separately address dismissals based on a party's withdrawal. We proposed in §§ 405.1052(c) and 423.2052(c) to include withdrawals of requests to review a QIC dismissal because we also proposed to add provisions to address other dismissals of those requests at §§ 405.1052(b) and 423.2052(b). We also proposed that an ALJ or attorney adjudicator may dismiss a request for review of a QIC dismissal based on a party's withdrawal of his or her request because as proposed in section II.B of the proposed rule (and discussed in section II.A.2 above), both ALJs and attorney adjudicators would be able to adjudicate requests to review a QIC dismissal. In addition, we proposed that an ALJ or attorney adjudicator may dismiss a request for hearing based on a party's withdrawal of his or her request. As discussed in section II.B of the proposed rule and II.A.2 of this final rule above, we believe that well-trained attorneys can efficiently perform a review of these requests and issue dismissals. We stated in the proposed rule that we believe using attorney adjudicators to the maximum extent possible would help OMHA be more responsive to appellants and allow ALJs to focus on conducting hearings and issuing decisions. We also proposed to revise the language in current §§ 405.1052(a)(1) and 423.2052(a)(1) (as re-designated in proposed §§ 405.1052(c) and 423.2052(c)) to (1) replace “notice of the hearing decision” with “notice of the decision, dismissal or remand” to reflect that a decision may be issued without a hearing, and to reflect other possible outcomes of the proceeding (dismissal and remand), and (2) clarify that a request to withdraw a request for hearing may be made orally at a hearing before the ALJ because only an ALJ may conduct a hearing.
Current § 405.1052(a)(2) describes three possible alternatives for dismissing a request for hearing when the party that requested the hearing, or the party's representative, does not appear at the time and place set for the hearing. We stated in the proposed rule that the current alternatives have caused confusion for appellants in understanding whether they are required to submit a statement explaining a failure to appear. Further, current provisions do not require evidence in the record to document an appellant was aware of the time and place of the hearing, and we stated that this has resulted in remands from the Council. We proposed to simplify the provision to provide two alternatives, and to require that contact has been made with an appellant and documented, or an opportunity to provide an explanation for failing to appear has been provided before a request for hearing is dismissed for failing to appear at the hearing. We proposed at § 405.1052(a)(1)(i) to set forth the first alternative which would provide that a request for hearing may be dismissed if the party that filed the request was notified before the time set for hearing that the request for hearing might be dismissed for failure to appear, the record contains documentation that the party acknowledged the notice of hearing, and the party does not contact the ALJ within 10 calendar days after the hearing or does contact the ALJ but does not provide good cause for not appearing. We proposed at § 405.1052(a)(1)(ii) to set forth the second alternative which would provide that a request for hearing may be dismissed if the record does not contain documentation that the party acknowledged the notice of hearing, but the ALJ sends a notice to the party at his or her last known address asking why the party did not appear, and the party does not respond to the ALJ's notice within 10 calendar days after receiving the notice or does respond but does not provide good cause for not appearing. In either circumstance, we proposed to maintain in § 405.1052(a)(1) the current standard that in determining whether good cause exists, the ALJ considers any physical, mental, educational, or linguistic limitations that the party may have identified. We stated in the proposed rule that we believed
Current OMHA policy provides that a request for hearing that does not meet the requirements of current § 405.1014 may be dismissed by an ALJ after an opportunity is provided to the appellant to cure an identified defect (OCPM, division 2, chapter 3, section II-3-6 D and E). We stated that a dismissal is appropriate because as an administrative matter, the proceedings on the request do not begin until the information necessary to adjudicate the request is provided and the appellant sends a copy of the request to the other parties. Additionally, a request cannot remain pending indefinitely once an appellant has demonstrated that he or she is unwilling to provide the necessary information or to send a copy of the request to the other parties. Therefore, we proposed at § 405.1052(a)(7) to explain that a request for hearing may be dismissed if the request is not complete in accordance with proposed § 405.1014(a)(1) or the appellant did not send copies of its request to the other parties in accordance with proposed § 405.1014(d), after the appellant is provided with an opportunity to complete the request and/or send copies of the request to the other parties. We stated in the proposed rule that we believed adding this provision would emphasize the importance of following the requirements for filing a request for hearing, and clarify the outcome if the requirements are not met and the appellant does not cure identified defects after being provided with an opportunity to do so. We proposed at § 423.2052(a)(7) to adopt a corresponding provision for dismissing a request for hearing under part 423, subpart U.
As discussed above, we proposed to add § 405.1052(b) to explain when a request for review of a QIC dismissal would be dismissed. Under proposed § 405.1052(b), a request for review could be dismissed in the following circumstances: (1) The person or entity requesting the review has no right to the review of the QIC dismissal under proposed § 405.1004; (2) the party did not request a review within the stated time period and the ALJ or attorney adjudicator has not found good cause for extending the deadline; (3) a beneficiary or beneficiary's representative filed the request for review and the beneficiary passed away while the request for review is pending and all of the following criteria apply: (i) a surviving spouse or estate has no remaining financial interest in the case, (ii) no other individuals or entities have a financial interest in the case and wish to pursue an appeal, and (iii) no other individual or entity filed a valid and timely request for a review of the QIC dismissal; and (4) the appellant's request for review is not complete in accordance with proposed § 405.1014(a)(1) or the appellant does not send a copy of the request to the other parties in accordance with proposed § 405.1014(d), after being provided with an opportunity to complete the request and/or send a copy of the request to the other parties. We stated in the proposed rule that we believed these provisions would encompass the reasons for dismissing a request for a review of a QIC dismissal, and are necessarily differentiated from dismissing a request for hearing because, as explained in section III.A.3.c of the proposed rule and II.B.3.c of this final rule above, we also stated that we did not believe there is a right to a hearing for requests for a review of a QIC dismissal. We proposed at § 423.2052(b) to adopt corresponding provisions for dismissing requests for a review of an IRE dismissal under part 423, subpart U proceedings.
As discussed above, current § 405.1052(b) describes the requirements for providing notice of the dismissal and we proposed to re-designate the paragraph as proposed § 405.1052(d). For the same reasons discussed in section III.A.3.v of the proposed rule and II.B.3.v of this final rule above for allowing a notice of a decision to be provided by means other than mail, we proposed in § 405.1052(d) that OMHA may mail or “otherwise transmit” notice of a dismissal. We proposed to revise § 423.2052(d) to adopt a corresponding revision for notices of dismissal under part 423, subpart U.
Current § 405.1052(b) requires notice of the dismissal to be sent to all parties at their last known address. However, we stated in the proposed rule that we believed that requirement is overly inclusive and causes confusion by requiring notice of a dismissal to be sent to parties who have not received a copy of the request for hearing or request for review that is being dismissed. Thus, we proposed to revise § 405.1052(d) to state that the notice of dismissal is sent to the parties who received a copy of the request for hearing or request for review because only those parties are on notice that a request was pending. In addition, we proposed at § 405.1052(d) that if a party's request for hearing or request for review is dismissed, the appeal would proceed with respect to any other parties who also filed a valid request for hearing or review regarding the same claim or disputed matter. This would address the rare circumstance in which more than one party submits a request, but the request of one party is dismissed. In that circumstance, the appeal proceeds on the request that was not dismissed, and the party whose request was dismissed remains a party to the proceedings but does not have any rights associated with a party that filed a request, such as the right to escalate a request for hearing. We did not propose a corresponding revision to § 423.2052(c) because only the enrollee is a party to an appeal under part 423, subpart U.
Current § 405.1052 does not include authority for an ALJ to vacate his or her own dismissal, and instead requires an appellant to request the Council review an ALJ's dismissal. As explained in the 2005 Interim Final Rule (70 FR 11465), the authority for an ALJ to vacate his or her own dismissal was not regarded as an effective remedy because the record was no longer in the ALJ hearing office, and the resolution was complicated when appellants simultaneously asked the ALJ to vacate the dismissal order and asked the Council to review the dismissal. However, we stated that in practice, the lack of the authority for an ALJ to vacate his or her own dismissal has constrained ALJs' ability to correct erroneous dismissals that can be easily remedied by the ALJ, and has caused unnecessary work for the Council. We proposed to add § 405.1052(e) to provide the authority for an ALJ or an attorney adjudicator, as proposed in section II.B of the proposed rule (and discussed in section II.A.2 above), to vacate his or her own dismissal within 6 months of the date of the notice of dismissal, in the same manner as a QIC can vacate its own dismissal. We stated in the proposed rule that we believed that this authority would reduce unnecessary appeals to the Council and provide a more timely resolution of dismissals for appellants, whether the dismissal was issued by an ALJ or attorney adjudicator. We also noted that the coordination for obtaining the administrative record and addressing instances in which an appellant also requests a review of the dismissal by the Council can be addressed through operational coordination among CMS, OMHA, and the DAB. We proposed in
To align the effects of a dismissal with proposed § 405.1052(e), we proposed to add § 405.1054(a) to state that the dismissal of a request for hearing is binding unless it is vacated by the ALJ or attorney adjudicator under § 405.1052(e), in addition to the current provision that allows the dismissal to be vacated by the Council under § 405.1108(b). To explain the effect of a dismissal of a request for review of a QIC dismissal, consistent with § 405.1004, we proposed in § 405.1054(b) to provide that the dismissal of a request for review of a QIC dismissal of a request for reconsideration is binding and not subject to further review unless it is vacated by the ALJ or attorney adjudicator under § 405.1052(e). We proposed in § 423.2054 to adopt corresponding revisions for the effect of dismissals of request for hearing and requests for review of an IRE dismissal under part 423, subpart U.
Provided below is a summary of the specific comment received and our response to this comment:
However, as discussed in section II.B.3.g.v of this final rule above, we agree that unrepresented beneficiaries may have difficulty meeting the copy requirement of proposed § 405.1014(d), and should be exempt from the consequence of failing to provide a copy of a request for hearing or review of a dismissal to the other parties. Consequently, we are revising § 405.1052(a)(7) and (b)(4) to provide that a request filed by an unrepresented beneficiary will not be dismissed if the appellant fails to send a copy of the request to the other parties in accordance with proposed § 405.1014(d).
With respect to the commenter's suggestion to always provide beneficiaries with the notice of dismissal by regular mail, we refer the commenter to our response to a similar comment in section II.B.3.v of this final rule above, where we explain why we do not believe a notice of decision sent to a beneficiary under § 405.1046(a) and § 423.2046(a) should always be sent by mail in addition to any other method of transmission that is used. We believe this explanation responds to the commenter's same suggestion with regard to a notice of dismissal.
After review and consideration of the comments received, for the reasons discussed above and in the proposed rule, we are finalizing the changes to §§ 405.1052, 405.1054, 423.2052 and 423.2054 as proposed, with the following modification. We are amending § 405.1052(a)(7) and (b)(4) to state that a request filed by an unrepresented beneficiary will not be subject to dismissal if the appellant fails to send a copy of the request to the other parties in accordance with § 405.1014(d).
Current § 405.1060 addresses the applicability of national coverage determinations (NCDs) to claim appeals brought under part 405, subpart I and provides that an ALJ and the Council may not disregard, set aside, or otherwise review an NCD, but may review the facts of a particular case to determine whether an NCD applies to a specific claim for benefits and, if so, whether the NCD was applied correctly to the claim. Current § 405.1062 addresses the applicability of local coverage determinations (LCDs) and other policies, and specifies that ALJs and the Council are not bound by LCDs, local medical review policies (LMRPs), or CMS program guidance, such as program memoranda and manual instructions, but will give substantial deference to these policies if they are applicable to a particular case, and if an ALJ or the Council declines to follow a policy in a particular case, the ALJ or the Council must explain the reasons why the policy was not followed. Similarly, current § 423.2062 states that ALJs and the Council are not bound by CMS program guidance but will give substantial deference to these policies if they are applicable to a particular case, and if an ALJ or the Council declines to follow a policy in a particular case, the ALJ or the Council must explain the reasons why the policy was not followed. Current §§ 405.1062 and 423.2062 also provide that an ALJ or Council decision to disregard a policy applies only to the specific claim being considered and does not have precedential effect. Further, § 405.1062 states that an ALJ or the Council may not set aside or review the validity of an LMRP or LCD for purposes of a claim appeal. Current §§ 405.1063 and 423.2063 address the applicability of laws, regulations, and CMS Rulings, and provide that all laws and regulations pertaining to the Medicare program (and for § 405.1063 the Medicaid program as well), including but not limited to Titles XI, XVIII, and XIX of the Act and applicable implementing regulations, are binding on ALJs and the Council, and consistent with § 401.108, CMS Rulings are binding on all HHS components that adjudicate matters under the jurisdiction of CMS.
We proposed to revise §§ 405.1060, 405.1062, 405.1063, 423.2062, and 405.2063 to replace “ALJ” or “ALJs” with “ALJ or attorney adjudicator” or “ALJs or attorney adjudicators” except in the second sentence of § 405.1062(c). 81 FR 43790, 43846. We stated that an attorney adjudicator would issue certain decisions and dismissals and therefore would apply the authorities addressed by these sections. We stated in the proposed rule that requiring the attorney adjudicators to apply the authorities in the same manner as an ALJ would provide consistency in the adjudication process, regardless of who
We received no comments on these proposals, other than comments discussed in section II.A.2 of this final rule above related to our general proposals to provide authority for attorney adjudicators to issue certain decisions, dismissals and remands, and to revise the rules so that decisions and dismissals issued by attorney adjudicators may be reopened and/or appealed in the same manner as equivalent decisions and dismissals issued by ALJs. Accordingly, for the reasons discussed above and in the proposed rule, we are finalizing the changes to §§ 405.1060, 405.1062, 405.1063, 423.2062, and 423.2063 as proposed without modification.
As described below, we proposed a number of changes to §§ 405.1100, 423.1974 and 423.2100 with respect to Council review, generally. 81 FR 43790, 43846-43847. Current § 405.1100 discusses the Council review process. Current § 405.1100(a) states that the appellant or any other party to the hearing may request that the Council review an ALJ's decision or dismissal. We proposed to revise § 405.1100(a) to replace “the hearing” with “an ALJ's or attorney adjudicator's decision or dismissal,” and “an ALJ's decision or dismissal,” with “the ALJ's or attorney adjudicator's decision or dismissal” because the parties are parties to the proceedings and the resulting decision or dismissal regardless of whether a hearing is conducted, and as proposed in section II.B of the proposed rule (and discussed in section II.A.2 above), an attorney adjudicator would be able to issue certain decisions or dismissals for which Council review may be requested.
Current § 423.1974 states that an enrollee who is dissatisfied with an ALJ hearing decision may request that the Council review the ALJ's decision or dismissal as provided in § 423.2102, and current § 423.2100(a) states that consistent with § 423.1974, the enrollee may request that the Council review an ALJ's decision or dismissal. We proposed to revise § 423.1974 to replace “ALJ hearing decision” with “an ALJ's or attorney adjudicator's decision or dismissal,” and to revise §§ 423.1974 and 423.2100(a) to replace “ALJ's decision or dismissal” with “an ALJ's or attorney adjudicator's decision or dismissal” because the parties are parties to the proceedings and resulting decision or dismissal regardless of whether a hearing is conducted, and as proposed in section II.B of the proposed rule (and discussed in section II.A.2 above), an attorney adjudicator may issue a decision or dismissal for which Council review may be requested.
Current § 405.1100(b) provides that under the circumstances set forth in §§ 405.1104 and 405.1108, an appellant may request escalation of a case to the Council for a decision even if the ALJ has not issued a decision or dismissal in his or her case. We proposed to revise § 405.1100(b) to provide that under circumstances set forth in §§ 405.1016 and 405.1108, the appellant may request that a case be escalated to the Council for a decision even if the ALJ or attorney adjudicator has not issued a decision, dismissal, or remand in his or her case. We stated in the proposed rule that these revisions would reference § 405.1016, which, as discussed in section III.A.3.h of the proposed rule and II.B.3.h of this final rule above, would replace the current § 405.1104 provisions for escalating a case from the OMHA level to the Council. We stated that they would also provide that in addition to potentially issuing a decision or dismissal, an ALJ or attorney adjudicator, as proposed in section II.B of the proposed rule (and discussed in section II.A.2 above), may issue a remand—this would present a complete list of the actions that an ALJ or attorney adjudicator could take on an appeal.
Current §§ 405.1100(c) and 423.2100(b) and (c) state in part that when the Council reviews an ALJ's decision, it undertakes a de novo review, and the Council issues a final decision or dismissal order or remands a case to the ALJ. We proposed to revise §§ 405.1100(c) and 423.2100(b) and (c) to state that when the Council reviews an ALJ's or attorney adjudicator's decision, it undertakes a de novo review and may remand a case to an ALJ or attorney adjudicator, so that the same standard for review is applied to ALJ and attorney adjudicator decisions. We also proposed to revise §§ 405.1100(c) and 423.2100(c) to state that the Council may remand an attorney adjudicator's decision to the attorney adjudicator so that like an ALJ, the attorney adjudicator can take the appropriate action ordered by the Council (however, if the Council were to order that a hearing must be conducted, the case would be transferred to an ALJ upon remand to the attorney adjudicator because only an ALJ may conduct a hearing).
Current § 423.2100(c) and (d) provide that the Council issues a final decision, dismissal order, or remand no later than the period of time specified in the respective paragraph, beginning on the date that the request for review is received by the entity specified in the ALJ's written notice of decision. We proposed to revise § 423.2100(c) and (d) to state that the period of time begins on the date that the request for review is received by the entity specified in the ALJ's or attorney adjudicator's written notice of decision because an attorney adjudicator may also issue a decision, as proposed in section II.B of the proposed rule (and discussed in section II.A.2 above). We also proposed to revise § 423.2100(c) to correct a typographical error by inserting “day” into the current “90 calendar period,” so it is clear to enrollees that the period of time being referenced is the 90 calendar day period.
Current § 405.1100(d) states in part that when deciding an appeal that was escalated from the ALJ level to the Council, the Council will issue a final decision or dismissal order or remand order within 180 calendar days of receipt of the appellant's request for escalation. A remand from the Council after an appeal is escalated to it is exceedingly rare and done in circumstances in which the Council must remand to an ALJ so that the ALJ may obtain information under current § 405.1034 that is missing from the written record and essential to resolving the issues on appeal, and that information can only be provided by CMS or its contractors, because the Council does not have independent authority to obtain the information from CMS or its contractors. In addition, an appeal may have not yet have been assigned to an ALJ, or could be assigned to an attorney adjudicator as proposed in section II.B of the proposed rule (and discussed in section II.A.2 above), when the appeal was escalated by the appellant. We proposed to revise § 405.1100(d) to state that if the Council remands an escalated appeal, the remand is to the OMHA Chief ALJ because the rare and unique circumstances in which an escalated appeal is remanded by the Council require immediate attention that the OMHA Chief ALJ is positioned to provide to minimize delay for the appellant, and to minimize confusion if the case was not assigned to an ALJ or
Provided below are summaries of the specific comments received and responses to these comments:
After review and consideration of the comments received, for the reasons discussed above and in the proposed rule, we are finalizing the changes to §§ 405.1100, 423.1974 and 423.2100 as proposed without modification.
As described below, we proposed a number of changes to §§ 405.1102 and 423.2102, which discuss requests for Council review when an ALJ issues a decision or dismissal. 81 FR 43790, 43847. Current §§ 405.1102(a)(1) and 423.2102(a)(1) provide that a party or enrollee, respectively, to “the ALJ hearing” may request a Council review if the party or enrollee files a written request for a Council review within 60 calendar days after receipt of the ALJ's decision or dismissal, which is in accordance with the criteria specified in current §§ 405.1102 and 423.2102. However, we stated in the proposed rule that a party or enrollee is a party to the proceedings and resulting decision or dismissal, and may appeal the decision or dismissal regardless of whether a hearing was conducted in the appeal, and as proposed in section II.B of the proposed rule (and discussed in section II.A.2 of this final rule above), an attorney adjudicator may issue a decision or dismissal for which Council review may be requested. To help ensure there is no confusion that a party or enrollee may seek Council review even if a hearing before an ALJ is not conducted or if an attorney adjudicator issues the decision or dismissal, we proposed to revise §§ 405.1102(a)(1) and 423.2102(a)(1) to state a party or enrollee to a decision or dismissal issued by an ALJ or attorney adjudicator may request Council review if the party or enrollee files a written request for a Council review within 60 calendar days after receipt of the ALJ's or attorney adjudicator's decision or dismissal.
Current §§ 405.1102(c) and 423.2102(c) provide that a party or enrollee, respectively, does not have a right to seek Council review of an ALJ's remand to a QIC or IRE, or an ALJ's affirmation of a QIC's or IRE's dismissal of a request for reconsideration. However, under current §§ 405.1004(c) and 423.2004(c), a party or enrollee, respectively, may currently seek Council review of a dismissal of a request for review of a QIC or IRE dismissal because, as discussed in section III.A.3.x of the proposed rule and II.B.3.x of this final rule above, an ALJ does not currently have the authority to vacate his or her own dismissal. As proposed in section II.B of the proposed rule (and discussed in section II.A.2 of this final rule above), an attorney adjudicator could adjudicate requests for a review of a QIC or IRE dismissal. In addition, proposed §§ 405.1052(e) and 423.2052(e) would establish the authority for an ALJ or attorney adjudicator to vacate his or her own dismissal, and in accordance with the policy that a review of a dismissal is only reviewable at the next level of appeal, as discussed in section III.A.3.c of the proposed rule and II.B.3.c of this final rule above, proposed §§ 405.1102(c) and 423.2102(c) would be revised to indicate that a party does not have the right to seek Council review of an ALJ's or attorney adjudicator's dismissal of a request for review of a QIC dismissal. Therefore, we proposed at §§ 405.1102(c) and 423.2102(c) to add that a party does not have the right to seek Council review of an ALJ's or attorney adjudicator's remand to a QIC or IRE, affirmation of a QIC's or IRE's dismissal of a request for reconsideration, or dismissal of a request for review of a QIC or IRE dismissal.
Provided below is a summary of the specific comment received and our response to this comment:
After review and consideration of the comments received, for the reasons discussed above and in the proposed rule, we are finalizing the changes to §§ 405.1102 and 423.2102 as proposed without modification.
As discussed below, we proposed a number of changes to §§ 405.1106 and 423.2106 with respect to where a request for review or escalation may be filed. 81 FR 43790, 43847-43848. Current §§ 405.1106(a) and 423.2106 provide that when a request for a Council review is filed after an ALJ has issued a decision or dismissal, the request for review must be filed with the entity specified in the notice of the ALJ's action, and under § 405.1106, the appellant must also send a copy of the request for review to the other parties to the ALJ decision or dismissal who received a copy of the hearing decision or notice of dismissal. The sections also
We proposed in §§ 405.1106 and 423.2106 to replace all instances of “ALJ” with “ALJ or attorney adjudicator,” and “ALJ's action” with “ALJ's or attorney adjudicator's action,” to provide that the sections apply to decisions and dismissals issued by an attorney adjudicator as well, as proposed in section II.B of the proposed rule (and discussed in section II.A.2 above), and therefore appellants would have the same right to seek Council review of the attorney adjudicator's decision or dismissal, and the Council would have the authority to take the same actions in reviewing an attorney adjudicator's decision or dismissal. We also proposed to replace “a copy of the hearing decision under § 405.1046(a) or a copy of the notice of dismissal under § 405.1052(b)” in § 405.1106(a) with “notice of the decision or dismissal,” because §§ 405.1046 and 405.1052 provide for notice of a decision or dismissal, respectively, to be sent, and a decision or dismissal may be issued by an ALJ or attorney adjudicator without conducting a hearing. In addition, in describing the consequences of failing to send a copy of the request for review to the other parties, we proposed to replace “until all parties to the hearing” in § 405.1106(a) to “until all parties to the ALJ or attorney adjudicator decision or dismissal,” to align the language with the preceding sentences.
We proposed to revise § 405.1106(b) to align the paragraph with the revised escalation process proposed at § 405.1016 (see section III.A.3.h.i of the proposed rule and II.B.3.h.i of this final rule above). Specifically, we proposed to revise § 405.1106(b) to state that if an appellant files a request to escalate an appeal to the Council level because the ALJ or attorney adjudicator has not completed his or her action on the request for hearing within an applicable adjudication period under § 405.1016, the request for escalation must be filed with OMHA and the appellant must also send a copy of the request for escalation to the other parties who were sent a copy of the QIC reconsideration. This proposed revision would align this section with the revised process in proposed § 405.1016 by specifying that the request for escalation is filed with OMHA and removing the requirement for an appellant to also file the request with the Council. In addition, proposed § 405.1106(b) would specify that the request for escalation must be sent to the other parties who were sent a copy of the QIC reconsideration, which would align with the parties to whom the appellant is required to send a copy of its request for hearing. Proposed § 405.1106(b) would also refer to “an applicable adjudication period” under § 405.1016, to align the terminology and because an adjudication period may not apply to a specific case (for example, if the appellant waived an applicable adjudication time frame). Finally, proposed § 405.1106(b) would provide that failing to copy the other parties would toll the Council's adjudication deadline until all parties who were sent a copy of the QIC reconsideration receive notice of the request for escalation, rather than notice of the request for Council review as is currently required, because the revised escalation process proposed at § 405.1016 would remove the requirement to file a request for Council review when escalation is requested from the OMHA to the Council level.
We received no comments on these proposals, other than comments discussed in section II.A.2 of this final rule above related to our general proposals to provide authority for attorney adjudicators to issue certain decisions, dismissals and remands, and to revise the rules so that decisions and dismissals issued by attorney adjudicators may be reopened and/or appealed in the same manner as equivalent decisions and dismissals issued by ALJs. Accordingly, for the reasons discussed above and in the proposed rule, we are finalizing the changes to §§ 405.1106 and 423.2106 as proposed without modification.
As described below, we proposed a number of changes to §§ 405.1108 and 423.2108, which describe the actions the Council may take upon receipt of a request for review or, for § 405.1108, a request for escalation. 81 FR 43790, 43848. We proposed at § 405.1108(d) introductory text to replace “ALJ level” with “OMHA level” to provide that the Council's actions with respect to a request for escalation are the same regardless of whether the case was pending before an ALJ or attorney adjudicator, or unassigned at the time of escalation. We also proposed at § 405.1108(d)(3) to replace “remand to an ALJ for further proceedings, including a hearing” with “remand to OMHA for further proceedings, including a hearing” because we stated in the proposed rule that we believed the Council could remand an escalated case to an ALJ or attorney adjudicator for further proceedings, but if the Council ordered that a hearing be conducted, the case would need to be remanded to an ALJ. We did not propose any corresponding changes to § 423.2108 because escalation is not available for Part D coverage appeals.
We also proposed in §§ 405.1108(b) and 423.2108(b), to provide that the dismissal for which Council review may be requested is a dismissal of a request for a hearing, because as discussed in section III.A.3.x of the proposed rule and II.B.3.x of this final rule above, proposed §§ 405.1054(b) and 423.2054(b) would provide that a dismissal of a request for a review of a QIC or IRE dismissal of a request for reconsideration is binding and not subject to further review. Finally, we proposed to replace all remaining references in §§ 405.1108 and 423.2108 to “ALJ” with “ALJ or attorney adjudicator” and “ALJ's” with “ALJ's or attorney adjudicator's” to further provide that the Council's actions with respect to a request for review or escalation are the same for cases that were decided by or pending before an ALJ or an attorney adjudicator.
We received no comments on these proposals, other than: (1) Comments discussed in section II.A.2 of this final rule above related to our general proposals to provide authority for attorney adjudicators to issue certain decisions, dismissals and remands, and to revise the rules so that decisions and dismissals issued by attorney adjudicators may be reopened and/or appealed in the same manner as equivalent decisions and dismissals
As described below, we proposed several changes to §§ 405.1110 and 423.2110, which discuss Council reviews on its own motion. 81 FR 43790, 43848-43849. Current §§ 405.1110(a) and 423.2110(a) state the general rule that the Council may decide on its own motion to review a decision or dismissal issued by an ALJ, and CMS or its contractor, including the IRE, may refer a case to the Council within 60 calendar days after the date of the ALJ's decision or dismissal (for § 405.1110(a)) or after the ALJ's written decision or dismissal is issued (for § 423.2110(a)). Current §§ 405.1110(b) and 423.2110(b) provide the standards for CMS or its contractors to refer ALJ decisions and dismissals to the Council for potential review under the Council's authority to review ALJ decisions and dismissals on the Council's own motion, and require that a copy of a referral to the Council be sent to the ALJ whose decision or dismissal was referred, among others. Current §§ 405.1110(c) and 423.2110(c) explain the standards of review used by the Council in reviewing the ALJ's action. Current §§ 405.1110(d) and 423.2110(d) explain the actions the Council may take, including remanding the case to the ALJ for further proceedings, and state that if the Council does not act on a referral within 90 calendar days after receipt of the referral (unless the 90 calendar day period has been extended as provided in the respective subpart), the ALJ's decision or dismissal is binding (§ 405.1110(d) further specifies that the decision or dismissal is binding on the parties to the decision).
We proposed at §§ 405.1110 and 423.2110 to replace each instance of “at the ALJ level” with “at the OMHA level” and “ALJ proceedings” with “OMHA proceedings.” We stated in the proposed rule that we believe the standards for referral to the Council by CMS or its contractor would be the same regardless of whether the case was decided by an ALJ or an attorney adjudicator, and that “at the OMHA level” and “OMHA proceedings” would reduce confusion in situations where the case was decided by an attorney adjudicator. We proposed at § 405.1110(b)(2) to replace the references to current § 405.1052(b) with references to § 405.1052(d) to reflect the structure of proposed § 405.1052, and also proposed to revise §§ 405.1110(b)(2) and 423.2110(b)(2)(ii) to state that CMS (in § 405.1110(b)(2)) or CMS or the IRE (in § 423.2110(b)(2)(ii)) sends a copy of its referral to the OMHA Chief ALJ. We stated that the current requirement to send a copy of the referral to the ALJ is helpful in allowing OMHA ALJs to review the positions that CMS is advocating before the Council, but at times has caused confusion as to whether the ALJ should respond to the referral (there is no current provision that allows the Council to consider a statement in response to the referral). In addition, we stated that the proposed revision would allow OMHA to collect information on referrals, assess whether training or policy clarifications for OMHA adjudicators are necessary, and disseminate the referral to the appropriate ALJ or attorney adjudicator for his or her information. We also proposed at § 405.1110(b)(2) to replace “all other parties to the ALJ's decision” with “all other parties to the ALJ's or attorney adjudicator's action” and at § 405.1110(d) to replace “ALJ decision” with “ALJ or attorney adjudicator action” to encompass both decisions and dismissals issued by an ALJ or an attorney adjudicator, as proposed in section II.B of the proposed rule (and discussed in section II.A.2 above). We stated in the proposed rule that we believe that parties to an ALJ's dismissal or an attorney adjudicator's decision or dismissal have the same right to receive a copy of another party's written exceptions to an agency referral as the parties to an ALJ's decision, and that an ALJ's or attorney adjudicator's decision or dismissal is binding on the parties to the action. We proposed to replace each remaining instance in §§ 405.1110 and 423.2110 of “ALJ” with “ALJ or attorney adjudicator,” “ALJ's decision or dismissal” with “ALJ's or attorney adjudicator's decision or dismissal,” “ALJ's decision” with “ALJ's or attorney adjudicator's decision or dismissal,” and “ALJ's action” with “ALJ's or attorney adjudicator's action.” We stated that these proposed revisions would provide that the sections apply to decisions and dismissals issued by an attorney adjudicator, as proposed in section II.B of the proposed rule (and discussed in section II.A.2 above), and therefore CMS and its contractors would have the same right to refer attorney adjudicator decisions and dismissals to the Council, and the Council would have the authority to take the same actions and have the same obligations in deciding whether to review an attorney adjudicator's decision or dismissal on its own motion.
Finally, we proposed at § 423.2110(b)(1) to replace “material to the outcome of the claim” with “material to the outcome of the appeal” because unlike Part A and Part B, no “claim” is submitted for drug coverage under Part D.
Provided below are summaries of the specific comments received and responses to these comments:
We understand the commenter's suggestion that the notice of the Council's action is a better measure to assess the need for possible training or policy clarifications. In practice, OMHA has a process in place to receive and review copies of all Council actions, such as decisions remanding, reversing, modifying, or affirming ALJ decisions and dismissals, and dismissals of requests for review and declinations of referrals for own motion review, and OMHA makes those available to all staff. However, due to the time lag between when a request for own motion review is filed and when the Council issues its action (which may be up to 90 days), we believe requiring CMS (under § 405.1110), or CMS or the IRE (under § 423.2110), to send a copy of its referral to OMHA, and specifically to the Chief ALJ, will help ensure OMHA is aware of any trends that may necessitate action or further research for possible training or policy clarifications as early as possible, with the understood caveat that a referral in and of itself is not a basis for training or policy clarification because, as the commenter suggests, the Council's action on the referral is needed to fully assess any needed training or policy clarifications.
After review and consideration of the comments received, for the reasons discussed above and in the proposed rule, we are finalizing the changes to § 405.908 as proposed with the following modification. We are correcting a drafting error in proposed § 405.1110(b)(2) by removing two references to a “hearing decision” issued under § 405.1046(a) and replacing them with “decision,” because § 405.1046(a) as finalized in this rule also addresses decisions issued by an ALJ or attorney adjudicator when a hearing is not held.
As described below, we proposed a number of changes to §§ 405.1112 and 423.2112, which discuss the content of a request for Council review. 81 FR 43790, 43849. Current § 405.1112(a) requires a request for Council review to contain the date of the ALJ's decision or dismissal order, if any, among other information. Current § 423.2112(a)(1) states that the request for Council review must be filed with the entity specified in the notice of the ALJ's action. Current §§ 405.1112(b) and 423.2112(b) state that the request for review must identify the parts of the ALJ action with which the party or enrollee, respectively, requesting review disagrees and explain why he or she disagrees with the ALJ's decision, dismissal, or other determination being appealed. Current § 405.1112(b) provides an example that if the party requesting review believes that the ALJ's action is inconsistent with a statute, regulation, CMS Ruling, or other authority, the request for review should explain why the appellant believes the action is inconsistent with that authority. Current §§ 405.1112(c) and 423.2112(c) state that the Council will limit its review of an ALJ's action to those exceptions raised by the party or enrollee, respectively, in the request for review, unless the appellant is an unrepresented beneficiary or the enrollee is unrepresented.
We proposed at §§ 405.1112 and 423.2112 to replace “ALJ's decision or dismissal” with “ALJ's or attorney adjudicator's decision or dismissal,” “ALJ action” with “ALJ's or attorney adjudicator's action,” and “ALJ's action” with “ALJ's or attorney adjudicator's action.” These revisions would provide that the sections apply to decisions and dismissals issued by an attorney adjudicator, as proposed in section II.B of the proposed rule (and discussed in section II.A.2 above), and therefore information on the attorney adjudicator's decision and dismissal must be included in the request for Council review, and the scope of the Council's review would be the same as for an ALJ's decision or dismissal.
Current § 405.1112(a) states that a request for Council review must be filed with the Council or appropriate ALJ hearing office. However, we stated in the proposed rule that this provision may cause confusion when read with current § 405.1106(a), which states that a request for review must be filed with the entity specified in the notice of the ALJ's action. In practice, OMHA notices of decision and dismissal provide comprehensive appeal instructions directing requests for Council review to be filed directly with the Council, and provide address and other contact information for the Council. Therefore, we proposed to revise § 405.1112(a) to state that the request for Council review must be filed with the entity specified in the notice of the ALJ's or attorney adjudicator's action, which would align § 405.1112(a) with current § 405.1106(a), and reaffirm that a request for Council review must be filed with the entity specified in the notice of the ALJ's or attorney adjudicator's action.
Current § 405.1112(a) also states that the written request for review must include the hearing office in which the appellant's request for hearing is pending if a party is requesting escalation from an ALJ to the Council. In light of the proposed revisions to the escalation process discussed in section III.A.3.h.i of the proposed rule and II.B.3.h.i of this final rule above, we proposed to remove this requirement from § 405.1112(a) because proposed § 405.1016 would provide that a request for escalation is filed with OMHA. In accordance with proposed § 405.1016, if the request for escalation meets the requirements of § 405.1016(f)(1) and a decision, dismissal, or remand cannot be issued within 5 calendar days after OMHA receives the request, the appeal would be forwarded to the Council.
Provided below is a summary of the specific comment received and our response to this comment:
After review and consideration of the comments received, for the reasons discussed above and in the proposed rule, we are finalizing the changes to §§ 405.1112 and 423.2112 as proposed without modification.
We proposed at § 405.1114(c)(3) to replace “ALJ hearing” with “ALJ's or attorney adjudicator's action.” This proposed revision would provide that the paragraph applies to decisions and dismissals issued by an attorney adjudicator, as proposed in section II.B of the proposed rule (and discussed in section II.A.2 above), and therefore a
We received no comments on these proposals, other than comments discussed in section II.A.2 of this final rule above related to our general proposals to provide authority for attorney adjudicators to issue certain decisions, dismissals and remands, and to revise the rules so that decisions and dismissals issued by attorney adjudicators may be reopened and/or appealed in the same manner as equivalent decisions and dismissals issued by ALJs. Accordingly, for the reasons discussed above and in the proposed rule, we are finalizing the changes to § 405.1114 as proposed without modification.
Current §§ 405.1116 and 423.2116 describe the effect of a dismissal by the Council of a request for Council review or a request for hearing. We proposed to replace “ALJ” with “ALJ or attorney adjudicator” to provide that the denial of a request for Council review of a dismissal issued by an attorney adjudicator is binding and not subject to judicial review in the same manner as the denial of a request for Council review of a dismissal issued by an ALJ. We stated in the proposed rule that we believe the Council's denial of a request to review an attorney adjudicator's dismissal would be subject to the same general rules described in sections III.A.3.c and III.A.3.x of the proposed rule and sections II.B.3.c and II.B.3.x of this final rule above pertaining to reviews of dismissals at the next adjudicative level, and that further review of the attorney adjudicator's dismissal in Federal district court would be unavailable. 81 FR 43790, 43849-43850.
We received no comments on these proposals, other than comments discussed in section II.A.2 of this final rule above related to our general proposals to provide authority for attorney adjudicators to issue certain decisions, dismissals and remands, and to revise the rules so that decisions and dismissals issued by attorney adjudicators may be reopened and/or appealed in the same manner as equivalent decisions and dismissals issued by ALJs. Accordingly, for the reasons discussed above and in the proposed rule, we are finalizing the changes to §§ 405.1116 and 423.2116 as proposed without modification.
As described below, we proposed several changes to §§ 405.1118 and 423.2118, which provide that a party or an enrollee, respectively, may request and receive a copy of all or part of the record of the ALJ hearing. 81 FR 43790, 43850. We proposed to replace “ALJ hearing” with “ALJ's or attorney adjudicator's action.” We stated in the proposed rule that this proposed revision would provide that a party to an attorney adjudicator action, or to an ALJ decision that was issued without a hearing, may request and receive a copy of all or part of the record to the same extent as a party to an ALJ hearing. We also proposed to replace the reference to an “exhibits list” with a reference to “any index of the administrative record” to provide greater flexibility in developing a consistent structure for the administrative record. In addition, we proposed at § 405.1118 to replace the reference to a “tape” of the oral proceeding with an “audio recording” of the oral proceeding because tapes are no longer used and a more general reference would accommodate future changes in recording formats. We proposed a parallel revision to § 423.2118 to replace the reference to a “CD” of the oral proceeding with an “audio recording” of the oral proceeding.
Provided below are summaries of the specific comments received and responses to these comments:
After review and consideration of the comments received, for the reasons discussed above and in the proposed rule, we are finalizing the changes to §§ 405.1118 and 423.2118 as proposed without modification.
As described below, we proposed several changes to §§ 405.1122 and 423.2122, which describe the evidence that may be submitted to and considered by the Council, the process the Council follows in issuing subpoenas, the reviewability of Council subpoena rulings, and the process for seeking enforcement of subpoenas. 81 FR 43790, 43850. Current § 405.1122(a)(1) provides that the Council will limit its review of the evidence to the evidence contained in the record of the proceedings before the ALJ, unless the hearing decision decides a new issue that the parties were not afforded an opportunity to address at the ALJ level. We proposed at § 405.1122(a) introductory text and (a)(1) to replace each instance of “ALJ's decision” with “ALJ's or attorney adjudicator's decision,” “before the ALJ” with “before the ALJ or attorney adjudicator,” and “the ALJ level” with “the OMHA level.” We stated in the proposed rule that we believe the standard for review of evidence at the Council level would be the same regardless of whether the case was decided by an ALJ or attorney adjudicator, as proposed in section II.B of the proposed rule (and discussed in section II.A.2 above), at the OMHA level. We also proposed corresponding revisions to § 423.2122(a) introductory text and (a)(1). Also, to help ensure it is clear that the exception for evidence related to new issues raised at the OMHA level is not limited to proceedings in which a hearing before an ALJ was conducted, we proposed at §§ 405.1122(a)(1) and § 423.2122(a)(1) to replace “hearing decision” with “ALJ's or attorney adjudicator's decision.”
We received no comments on these proposals, other than: (1) Comments discussed in section II.A.2 of this final rule above related to our general proposals to provide authority for attorney adjudicators to issue certain decisions, dismissals and remands, and to revise the rules so that decisions and dismissals issued by attorney adjudicators may be reopened and/or appealed in the same manner as equivalent decisions and dismissals issued by ALJs; and (2) comments discussed in section II.A.4 of this final rule above related to our general proposal to reference OMHA or an OMHA office, in place of current references to an unspecified entity, ALJs, and ALJ hearing offices, when a reference to OMHA or an OMHA office provides a clearer explanation of a topic. Accordingly, for the reasons discussed above and in the proposed rule, we are finalizing the changes to §§ 405.1122 and 423.2122 as proposed without modification.
As described below, we proposed a number of changes to the regulations at §§ 405.1126 and 423.2126 concerning cases that are remanded by the Council. 81 FR 43790, 43850-43851. Current §§ 405.1126(a) and (b) explain the Council's remand authority. We proposed to replace each instance of “ALJ” with “ALJ or attorney adjudicator” to provide that the Council may remand a case in which additional evidence is needed or additional action is required by the ALJ or attorney adjudicator, as proposed in section II.B of the proposed rule (and discussed in section II.A.2 of this final rule above). Proposed § 405.1126(b) would also provide that an ALJ or attorney adjudicator would take any action that is ordered by the Council, and may take any additional action that is not inconsistent with the Council's remand order. We stated in the proposed rule that we believe it is necessary for the Council to have the same authority to remand an attorney adjudicator's decision to the attorney adjudicator as the Council currently has to remand an ALJ's decision to the ALJ, and that the attorney adjudicator's actions with respect to the remanded case should be subject to the same requirements as an ALJ's actions under the current provisions. We also proposed corresponding revisions to § 423.2126(a)(1) and (a)(2). Current §§ 405.1126(c) and (d) describe the procedures that apply when the Council receives a recommended decision from the ALJ, including the right of the parties to file briefs or other written statements with the Council. Because we proposed in § 405.1126(a) for the Council to have the same authority to order an attorney adjudicator to issue a recommended decision on remand as the Council currently has to order an ALJ to issue a recommended decision, we also proposed at § 405.1126(c) and (d) to replace “ALJ” with “ALJ or attorney adjudicator” to provide that the provisions apply to attorney adjudicators to the same extent as the provisions apply to ALJs, along with corresponding revisions to § 423.2126(a)(3) and (a)(4). Finally, current § 405.1126(e)(2) provides that if the Council determines more evidence is required after receiving a recommended decision, the Council may again remand the case to an ALJ for further development and another decision or recommended decision. Because we believe the Council should have the same authority to remand a case to an attorney adjudicator following receipt of a recommended decision, we proposed at § 405.1126(e)(2) to replace “ALJ” with “ALJ or attorney adjudicator,” along with a corresponding revision to § 423.2126(a)(5)(ii), and to insert “if applicable” after rehearing because a rehearing may not be applicable in every circumstance (for example, where an attorney adjudicator issued a recommended decision and the Council does not remand with instructions to transfer the appeal to an ALJ for a hearing).
We received no comments on these proposals, other than comments discussed in section II.A.2 of this final rule above related to our general proposals to provide authority for attorney adjudicators to issue certain decisions, dismissals and remands, and to revise the rules so that decisions and dismissals issued by attorney adjudicators may be reopened and/or appealed in the same manner as equivalent decisions and dismissals issued by ALJs. Accordingly, for the reasons discussed above and in the proposed rule, we are finalizing the changes to §§ 405.1126 and 423.2126 as proposed without modification.
Current §§ 405.1128 and 423.2128 explain the actions the Council may take after reviewing the administrative record and any additional evidence (subject to the limitations on Council consideration of additional evidence). We proposed at §§ 405.1128(a) and 423.2128(a) to replace “ALJ” with “ALJ or attorney adjudicator,” which would provide that the Council may make a decision or remand a case to an ALJ or to an attorney adjudicator, as proposed in section II.B of the proposed rule (and discussed in section II.A.2 of this final rule above). We stated in the proposed rule that we believe the Council should have the same authority to remand a case to an attorney adjudicator as the Council currently has to remand a case to an ALJ. Also, to help ensure there is no confusion that Council actions are not limited to proceedings in which a hearing before an ALJ was conducted, we proposed at §§ 405.1128(b) and 423.2128(b) to replace “the ALJ hearing decision” with “the ALJ's or attorney adjudicator's decision.” 81 FR 43790, 43851.
We received no comments on these proposals, other than comments discussed in section II.A.2 of this final rule above related to our general proposals to provide authority for attorney adjudicators to issue certain decisions, dismissals and remands, and
Current § 405.1132 explains the process for an appellant to seek escalation of an appeal (other than an appeal of an ALJ dismissal) from the Council to Federal district court if the Council does not issue a decision or dismissal or remand the case to an ALJ within the adjudication time frame specified in § 405.1100, or as extended as provided in subpart I. We proposed at § 405.1132 to replace each instance of “ALJ” with “ALJ or attorney adjudicator.” We stated in the proposed rule that these revisions would provide that the appellant may request that escalation of a case, other than a dismissal issued by an ALJ or attorney adjudicator, as proposed in section II.B of the proposed rule (and discussed in section II.A.2 of this final rule above), to Federal district court if the Council is unable to issue a decision or dismissal or remand the case to an ALJ or attorney adjudicator within an applicable adjudication time frame, and that appellants may file an action in Federal district court if the Council is not able to issue a decision, dismissal, or remand to the ALJ or attorney adjudicator within 5 calendar days of receipt of the request for escalation or 5 calendar days from the end of the applicable adjudication time period. We did not propose any corresponding changes to part 423, subpart U, as there is no equivalent provision because there are no escalation rights for Part D coverage appeals. 81 FR 43790, 43851.
We received no comments on these proposals, other than comments discussed in section II.A.2 of this final rule above related to our general proposals to provide authority for attorney adjudicators to issue certain decisions, dismissals and remands, and to revise the rules so that decisions and dismissals issued by attorney adjudicators may be reopened and/or appealed in the same manner as equivalent decisions and dismissals issued by ALJs. Accordingly, for the reasons discussed above and in the proposed rule, we are finalizing the changes to § 405.1132 as proposed without modification.
Current §§ 405.1136, 423.1976, and 423.2136 set forth the right to file a request for judicial review in Federal district court of a Council decision (or of an ALJ's decision if the Council declines review as provided in § 423.1976(a)(1)). Current § 405.1136 also provides that judicial review in Federal district court may be requested if the Council is unable to issue a decision, dismissal, or remand within the applicable time frame following an appellant's request for escalation. In addition, current §§ 405.1136 and 423.2136 specify the requirements and procedures for filing a request for judicial review, the Federal district court in which such actions must be filed, and describe the standard of review. We proposed at §§ 405.1136, 423.1976, and 423.2136 to replace each instance of “ALJ” with “ALJ or attorney adjudicator,” and “ALJ's” with “ALJ's or attorney adjudicator's” to help ensure that there is no confusion that appellants may file a request for judicial review in Federal district court of actions made by an attorney adjudicator, as proposed in section II.B of the proposed rule (and discussed in section II.A.2 of this final rule above) (or by the Council following an action by an attorney adjudicator), to the same extent that judicial review is available for ALJ actions (or Council actions following an action by an ALJ). 81 FR 43790, 43851.
We received no comments on these proposals, other than comments discussed in section II.A.2 of this final rule above related to our general proposals to provide authority for attorney adjudicators to issue certain decisions, dismissals and remands, and to revise the rules so that decisions and dismissals issued by attorney adjudicators may be reopened and/or appealed in the same manner as equivalent decisions and dismissals issued by ALJs. Accordingly, for the reasons discussed above and in the proposed rule, we are finalizing the changes to §§ 405.1136, 423.1976, and 423.2136 as proposed without modification.
Current §§ 405.1138 and 423.2138 set forth the actions the Council may take when a Federal district court remands a case to the Secretary for further consideration. We proposed at §§ 405.1138 and 423.2138 to replace “ALJ” with “ALJ or attorney adjudicator” to provide that when a case is remanded by a Federal district court for further consideration by the Secretary, the Council may remand the case to an ALJ or attorney adjudicator, as proposed in section II.B of the proposed rule (and discussed in section II.A.2 of this final rule above), to issue a decision, take other action, or return the case to the Council with a recommended decision. 81 FR 43790, 43851.
We received no comments on these proposals, other than comments discussed in section II.A.2 of this final rule above related to our general proposals to provide authority for attorney adjudicators to issue certain decisions, dismissals and remands, and to revise the rules so that decisions and dismissals issued by attorney adjudicators may be reopened and/or appealed in the same manner as equivalent decisions and dismissals issued by ALJs. Accordingly, for the reasons discussed above and in the proposed rule, we are finalizing the changes to §§ 405.1138 and 423.2138 as proposed without modification.
Current §§ 405.1140 and 423.2140 set forth the procedures that apply when a case is remanded to the Secretary for further consideration, and the Council subsequently remands the case to an ALJ, including the procedures for the Council to assume jurisdiction following the decision of the ALJ on its own initiative or upon receipt of written exceptions from a party or the enrollee. We proposed to replace each instance of “ALJ” throughout §§ 405.1140 and 423.2140 with “ALJ or attorney adjudicator” and to replace the reference to “ALJ's” at §§ 405.1140(d) and 423.2140(d) with “ALJ's or attorney adjudicator's.” We stated in the proposed rule that these revisions would provide that the Council may remand these cases to the ALJ or attorney adjudicator, as proposed in section II.B of the proposed rule (and discussed in section II.A.2 above), following remand from a Federal district court, and that the decision of the ALJ or attorney adjudicator becomes the final decision of the Secretary after remand unless the Council assumes jurisdiction. We stated that these revisions would further apply the rules set forth in this section to cases reviewed by an attorney adjudicator as well as an ALJ. As described above in relation to the Council's general remand authority under §§ 405.1126 and 423.2126, we stated that we believe it is necessary for the Council to have the same authority to remand an attorney
We received no comments on these proposals, other than comments discussed in section II.A.2 of this final rule above related to our general proposals to provide authority for attorney adjudicators to issue certain decisions, dismissals and remands, and to revise the rules so that decisions and dismissals issued by attorney adjudicators may be reopened and/or appealed in the same manner as equivalent decisions and dismissals issued by ALJs. Accordingly, for the reasons discussed above and in the proposed rule, we are finalizing the changes to §§ 405.1140 and 423.2140 as proposed without modification.
In accordance with section 1869(b)(1)(F) of the Act, current § 405.1204 provides for expedited QIC reconsiderations of certain QIO determinations related to provider-initiated terminations of Medicare-covered services and beneficiary discharges from a provider's facility. Current § 405.1204(c)(4)(iii) explains that the QIC's initial notification may be done by telephone followed by a written notice that includes information about the beneficiary's right to appeal the QIC's reconsideration decision to an ALJ, and current § 405.1204(c)(5) provides that if the QIC does not issue a decision within 72 hours of receipt of the request for a reconsideration, the case can be escalated to the “ALJ hearing level.” For consistency with part 405, subpart I, and to explain the rules that apply to an ALJ hearing, we proposed at § 405.1204(c)(4)(iii) and (c)(5) to amend these references to convey that a QIC reconsideration can be appealed to, or a request for a QIC reconsideration can be escalated to OMHA for an ALJ hearing in accordance with part 405, subpart I. We stated in the proposed rule that we believed these revisions would explain where a request for an ALJ hearing is directed from a subpart J proceeding, and the rules that would be applied to the request for an ALJ hearing following the QIC's reconsideration or escalation of the request for a QIC reconsideration. 81 FR 43790, 43852.
Current § 405.1204(c)(5) states that the beneficiary has a right to escalate a request for a QIC reconsideration if the amount remaining in controversy after the QIO determination is $100 or more. However, this is inconsistent with the amount in controversy specified in section 1869(b)(1)(E) of the Act. We proposed to revise § 405.1204(c)(5) to provide that there is a right to escalate a request for a QIC reconsideration if the amount remaining in controversy after the QIO determination meets the requirements for an ALJ hearing under § 405.1006. We stated in the proposed rule that we believed that this is more consistent with section 1869(b)(1)(E) of the Act, which provides that a hearing by the Secretary shall not be available to an individual if the amount in controversy is less than $100, as adjusted annually after 2004, which is implemented in § 405.1006, and would bring consistency to the amounts in controversy required for an escalation under subpart J and subpart I. 81 FR 43790, 43852.
Provided below is a summary of the specific comment received and our response to this comment:
After review and consideration of the comments received, for the reasons discussed above and in the proposed rule, we are finalizing the changes to § 405.1204 as proposed without modification.
Current § 422.562(c)(1)(ii) states that if an enrollee receives immediate QIO review of a determination of non-coverage of inpatient hospital care, the QIO review decision is subject only to the appeal procedures set forth in parts 476 and 478 of title 42, chapter IV. However, we stated in the proposed rule that we believe this provision is an outdated reference that has been superseded by current § 422.622, which provides for requesting immediate QIO review of the decision to discharge an enrollee from an inpatient hospital setting and appeals of that review as described under part 422, subpart M. The regulatory provisions at § 422.622 describe the processes for QIO review of the decision to discharge an MA enrollee from the inpatient hospital setting. Section 422.622 also explains the availability of other appeals processes if the enrollee does not meet the deadline for an immediate QIO review of the discharge decision. These part 422, subpart M provisions govern the review processes for MA enrollees disputing discharge from an inpatient hospital setting. As noted above, we stated in the proposed rule that we believe the references to the procedures in parts 476 and 478 at § 422.562(c)(1)(ii) are obsolete. Therefore, we proposed to delete § 422.562(c)(1) to remove the outdated reference in current § 422.562(c)(1)(ii) and consolidate current (c)(1) and (c)(1)(i) into proposed (c)(1). 81 FR 43790, 43852.
We received no comments on these proposals. Accordingly, for the reasons discussed above and in the proposed rule, we are finalizing these changes to § 422.562 as proposed above without modification.
In addition to the revisions discussed above, as discussed in section II.A.3 of this final rule, we are also finalizing revisions to § 422.562(d). In section II.A.3 of this final rule above, we discuss our proposal to revise § 422.562(d), the comments we received related to this proposal, and the revisions we are finalizing to § 422.562(d) in this rule.
Current § 422.594(b)(2) requires the notice of the reconsideration determination by an IRE to inform the parties of their right to an ALJ hearing if the amount in controversy is $100 or more, if the determination is adverse (does not completely reverse the MAO's adverse organization determination). We proposed at § 422.594(b)(2) to amend this requirement so that the notice informs the parties of their right to an ALJ hearing if the amount in controversy meets the requirements of § 422.600, which in turn refers to the part 405 computation of the amount in controversy. We stated in the proposed rule that we believed this would increase accuracy in conveying when a party has a right to an ALJ hearing, and would be more consistent with section 1852(g)(5) of the Act, which provides that a hearing by the Secretary shall not be available to an individual if the amount in controversy is less than $100, as adjusted annually in accordance with section 1869(b)(1)(E)(iii) of the Act, which is implemented in part 405 at § 405.1006. 81 FR 43790, 43852.We discuss our proposed changes to § 405.1006 in section III.A.3.d of the proposed rule and II.B.3.d of this final rule above.
We received no comments on these proposals. Accordingly, for the reasons discussed above and in the proposed
Current § 422.602(b) provides that a party must file a request for an ALJ hearing within 60 days of the date of the notice of the IRE's reconsidered determination. However, in similar appeals brought under Medicare Part A and Part B at § 405.1002, and Part D at § 423.2002, a request for an ALJ hearing must be filed within 60 calendar days of receipt of a notice of reconsideration. We proposed at § 422.602(b)(1) to align the part 422 time frame for filing a request for an ALJ hearing with provisions for similar appeals under Medicare Part A and Part B, and Part D. We proposed that a request for an ALJ hearing would be required to be filed within 60 calendar days of receiving the notice of a reconsidered determination, except when the time frame is extended by an ALJ or, as proposed, attorney adjudicator, as provided in part 405. To provide consistency for when a notice of a reconsidered determination is presumed to have been received, we proposed at § 422.602(b)(2) that the date of receipt of the reconsideration is presumed to be 5 calendar days after the date of the notice of the reconsidered determination, unless there is evidence to the contrary, which is the same presumption that is applied to similar appeals under Medicare Part A and Part B at § 405.1002, and Part D at § 423.2002. 81 FR 43790, 43852-43853.
Provided below are summaries of the specific comments received and responses to these comments:
After review and consideration of the comments received, for the reasons discussed above and in the proposed rule, we are finalizing the changes to § 422.602 as proposed without modification.
Current § 422.608 provides that any party to the hearing, including the MAO, who is dissatisfied with the ALJ hearing decision may request that the Council review the ALJ's decision or dismissal. We stated in the proposed rule that we believed that the reference to a “hearing” or “hearing decision,” in the first instance, then “decision or dismissal” in the second instance, may cause confusion regarding a party's right to request Council review. We proposed at § 422.608 that any party (including the MAO) to the ALJ's or, as proposed in section II.B of the proposed rule (and discussed in section II.A.2 of this final rule above), attorney adjudicator's decision or dismissal, who is dissatisfied with the decision or dismissal, may request that the Council review that decision or dismissal. We stated in the proposed rule that we believed this would resolve any potential confusion regarding a party's right to request Council review of a decision when a hearing was not conducted and a dismissal of a request for hearing, and further provide that the section applies to decisions and dismissals issued by an attorney adjudicator. Therefore, we proposed to revise § 422.608 to provide that a request for Council review may be filed by a party (including the MAO) if he or she is dissatisfied with an ALJ's or attorney adjudicator's decision or dismissal. 81 FR 43790, 43853.
We received no comments on these proposals, other than comments discussed in section II.A.2 of this final rule above related to our general proposals to provide authority for attorney adjudicators to issue certain decisions, dismissals and remands, and to revise the rules so that decisions and dismissals issued by attorney adjudicators may be reopened and/or appealed in the same manner as equivalent decisions and dismissals issued by ALJs. Accordingly, for the reasons discussed above and in the proposed rule, we are finalizing these changes to § 422.608 as proposed above without modification.
In addition to the revisions discussed above, as discussed in section II.A.3 of this final rule, we also are revising § 422.608 to include a cross reference to § 422.562(d)(2).
Current § 422.612 provides the circumstances under which a party may request judicial review of an ALJ or Council decision, and directs appellants to the procedures in part 405 for filing a request for judicial review. We proposed at § 422.612(a) to replace each instance of “ALJ's” with “ALJ's or attorney adjudicator's”. Thus, we proposed in § 422.612(a) that appellants would be able to file a request for judicial review in Federal district court of actions made by an attorney adjudicator, as proposed in section II.B of the proposed rule (and discussed in section II.A.2 above) (or by the Council following an action by an attorney adjudicator), to the same extent that judicial review is available under § 412.622(a) for ALJ actions (or Council actions following an action by an ALJ). 81 FR 43790, 43853.
We received no comments on these proposals, other than comments discussed in section II.A.2 of this final rule above related to our general proposals to provide authority for attorney adjudicators to issue certain decisions, dismissals and remands, and to revise the rules so that decisions and dismissals issued by attorney adjudicators may be reopened and/or appealed in the same manner as equivalent decisions and dismissals issued by ALJs. Accordingly, for the reasons discussed above and in the proposed rule, we are finalizing the changes to § 422.612 as proposed without modification.
Current § 422.616(a) provides that the determination or decision of an MA organization, independent entity, ALJ, or the Council that is otherwise final and binding may be reopened and revised by the entity that made the determination or decision, subject to the rules in part 405. We proposed at § 422.616(a) to replace “ALJ” with “ALJ or attorney adjudicator.” As described in section III.A.2.l of the proposed rule and II.B.2.l of this final rule above with respect to §§ 405.980, 405.982, 405.984, 423.1980, 423.1982, and 423.1984, we believe it is necessary for an attorney adjudicator to have the authority to reopen the attorney adjudicator's decision on the same bases as an ALJ may reopen the ALJ's decision under the current rules, and the action should be subject to the same limitations and requirements, and have the same effects
We received no comments on these proposals, other than comments discussed in section II.A.2 of this final rule above related to our general proposals to provide authority for attorney adjudicators to issue certain decisions, dismissals and remands, and to revise the rules so that decisions and dismissals issued by attorney adjudicators may be reopened and/or appealed in the same manner as equivalent decisions and dismissals issued by ALJs. Accordingly, for the reasons discussed above and in the proposed rule, we are finalizing the changes to § 422.616 as proposed without modification.
Current § 422.618(c)(1) and (c)(2) provide instructions for effectuation of decisions issued by an ALJ, or at a higher level of appeal, that reverse an IRE's decision on a standard reconsidered determination or decision. We proposed to replace “ALJ” with “ALJ or attorney adjudicator” at § 422.618(c)(1) and to make corresponding changes to § 422.619(c)(1) for decisions that reverse an IRE's decision on an expedited reconsidered determination or decision. We stated in the proposed rule that we believe the process for effectuating the decision of an attorney adjudicator, as proposed in section II.B of the proposed rule (and discussed in section II.A.2 of this final rule above), should be the same as the process for effectuating the decision of an ALJ. 81 FR 43790, 43853.
We received no comments on these proposals, other than comments discussed in section II.A.2 of this final rule above related to our general proposals to provide authority for attorney adjudicators to issue certain decisions, dismissals and remands, and to revise the rules so that decisions and dismissals issued by attorney adjudicators may be reopened and/or appealed in the same manner as equivalent decisions and dismissals issued by ALJs. Accordingly, for the reasons discussed above and in the proposed rule, we are finalizing the changes to §§ 422.618 and 422.619 as proposed without modification.
In accordance with section 1852(g)(3) and (g)(4) of the Act, current §§ 422.622 and 422.626 provide for reviews of QIO determinations and expedited IRE reconsiderations of certain QIO determinations related to terminations of covered provider services furnished by home health agencies (HHAs), skilled nursing facilities (SNFs), and comprehensive outpatient rehabilitation facilities (CORFs) to an MA enrollee, and MA enrollee discharges from an inpatient hospital. Current § 422.622(g) provides that if an enrollee is still an inpatient in the hospital after a QIO determination reviewing a provider discharge from a hospital, the enrollee may request an IRE reconsideration of the QIO determination in accordance with § 422.626(g); and if an enrollee is no longer an inpatient in the hospital, the enrollee may appeal the QIO determination to an ALJ. Current § 422.626(g)(3) provides that if the IRE reaffirms its decision to terminate covered provider services furnished by an HHA, SNF, or CORF in whole or in part, the enrollee may appeal the IRE's reconsidered determination to an ALJ. We proposed at §§ 422.622(g)(2) and 422.626(g)(3) to amend these references to provide that the appeal is made to OMHA for an ALJ hearing. We stated in the proposed rule that we believed these revisions would clarify where a request for an ALJ hearing is directed. 81 FR 43790, 43853.
We received no comments on these proposals, other than comments discussed in section II.A.4 of this final rule above related to our general proposal to reference OMHA or an OMHA office, in place of current references to an unspecified entity, ALJs, and ALJ hearing offices, when a reference to OMHA or an OMHA office provides a clearer explanation of a topic. Accordingly, for the reasons discussed above and in the proposed rule, we are finalizing the changes to §§ 422.622 and 422.626 as proposed without modification.
Current § 478.14(c)(2) explains that for the purposes of part 478 reconsideration and appeals, limitation of liability determinations on excluded coverage of certain services are made under section 1879 of the Act, and initial determinations under section 1879 of the Act and further appeals are governed by the reconsideration and appeal procedures in part 405, subpart G for determinations under Medicare Part A, and part 405, subpart H for determinations under Medicare Part B. In addition, current § 478.40 states that an ALJ hearing may be obtained from the SSA Office of Hearings and Appeals, and the provisions of subpart G of 42 CFR part 405 apply unless they are inconsistent with the specific provisions of subpart B of 42 CFR part 478. We stated in the proposed rule that these references are outdated. Since §§ 478.14 and 478.40 were last updated in 1999, section 931 of the MMA transferred responsibility for the ALJ hearing function from SSA to HHS, and HHS established OMHA in 2005, to administer the ALJ hearing function, including ALJ hearings conducted under titles XI and XVIII of the Act (see 70 FR 36386). In addition, BIPA and the MMA established new appeal procedures that were implemented in 2005, at 42 CFR part 405, subpart I (70 FR 11420), and the portions of subparts G and H that previously applied to part 478, subpart B appeals were removed in 2012 (77 FR 29002). We proposed in §§ 478.14 and 478.40 to replace the current outdated references to part 405, subparts G and H, with references to part 405, subpart I. We also proposed in § 478.40 to update the reference to the entity with responsibility for the ALJ hearing function by replacing the SSA Office of Hearings and Appeals with OMHA. 81 FR 43790, 43854.
We received no comments on these proposals. Accordingly, for the reasons discussed above and in the proposed rule, we are finalizing these changes to §§ 478.14 and 478.40 as proposed above without modification.
In addition to the revisions discussed above, as discussed in section II.A.3 of this final rule, we are also finalizing revisions to § 478.40(c). In section II.A.3 of this final rule above, we discuss our proposal to revise § 478.40(c), the comments we received related to this proposal, and the revisions we are finalizing to § 478.40(c) in this rule.
Similar to current § 478.40, as discussed above, current § 478.42(a) has outdated references to SSA offices that are no longer involved in the Medicare claim appeals process. In addition, current § 478.42(a) permits beneficiaries to file requests for an ALJ hearing with other entities, which could cause significant delays in obtaining a hearing
Current § 478.42(b) requires that a request for hearing is filed within 60 calendar days of receipt of the notice of the QIO reconsidered determination and the date of receipt is assumed to be 5 days after the date on the notice unless there is a reasonable showing to the contrary. Current § 478.42(b) also provides that a request is considered filed on the date it is postmarked. To align part 478, subpart B with procedures for requesting an ALJ hearing under part 405, subpart I; part 422, subpart M; and part 423, subpart U, we proposed in § 478.42(b) to provide that the request for hearing must be filed within 60 “calendar” days of receiving notice of the QIO reconsidered determination and that the notice is presumed to be received 5 “calendar” days after the date of the notice. In addition, to further align the part 478, subpart B procedures for requesting an ALJ hearing with the other parts, we proposed in § 478.42(c) to amend the standard to demonstrate that notice of QIO reconsidered determination was not received within 5 calendar days by requiring “evidence” rather than the current “reasonable showing,” and also to revise when a request is considered filed, from the date it is postmarked to the date it is received by OMHA. These changes would create parity with requests for hearing filed by beneficiaries and enrollees for similar services but under other parts of title 42, chapter IV. 81 FR 43790, 43854.
Provided below is a summary of the specific comment received and our response to this comment:
After review and consideration of the comments received, for the reasons discussed above and in the proposed rule, we are finalizing the changes to § 478.42 as proposed without modification.
Current § 478.44(a) explains how the amount in controversy for an ALJ hearing is determined in part 478, subpart B hearings. Current § 478.44(a) has outdated references to §§ 405.740 and 405.817 from part 405, subparts G and H respectively, for calculating the amount in controversy for an individual appellant or multiple appellants. In 2012, subpart G was removed and subpart H was significantly revised and no longer applies to Medicare claim appeals (77 FR 29002). To update these reference to the current part 405 rules, we proposed in § 478.44(a) to replace the outdated cross-references for calculating the amount in controversy with references to § 405.1006(d) and (e), which describe the calculation for determining the amount in controversy and the standards for aggregating claims by an individual appellant or multiple appellants. 81 FR 43790, 43854. We discuss our proposed changes to § 405.1006 in section III.A.3.d of the proposed rule and II.B.3.d of this final rule above.
Current § 478.44(b) and (c) explain that if an ALJ determines the amount in controversy is less than $200, the ALJ, without holding a hearing, notifies the parties to the hearing, and if a request for hearing is dismissed because the amount in controversy is not met, a notice will be sent to the parties to the hearing. However, when a request for hearing is dismissed because the amount in controversy is not met, no hearing is conducted and the parties to the proceedings are the same regardless of whether a hearing was conducted. To prevent potential confusion, we proposed in § 478.44(b) and (c) to replace “parties to the hearing” with “parties” so it is understood that they are parties regardless of whether a hearing is conducted. Because an attorney adjudicator would have to determine whether appeals assigned to him or her, as proposed in section II.B of the proposed rule (and discussed in section II.A.2 of this final rule above), meet the amount in controversy requirement, we also proposed at § 478.44(a) and (b) that an attorney adjudicator may determine the amount in controversy, and may determine that the amount in controversy is less than $200 and notify the parties to submit additional evidence to prove that the amount in controversy is at least $200. However, because we did not propose authority for an attorney adjudicator to dismiss a request for an ALJ hearing because the amount in controversy is not met, we proposed in § 478.44(c) that in cases where an attorney adjudicator has requested that the parties submit additional evidence related to the amount in controversy, an ALJ would dismiss the request for hearing if at the end of the 15-day period to submit additional evidence to prove that the amount in controversy is at least $200, the ALJ determines that the amount in controversy is less than $200. 81 FR 43790, 43854.
We received no comments on these proposals, other than comments discussed in section II.A.2 of this final rule above related to our general proposals to provide authority for attorney adjudicators to issue certain decisions, dismissals and remands, and to revise the rules so that decisions and dismissals issued by attorney adjudicators may be reopened and/or appealed in the same manner as equivalent decisions and dismissals issued by ALJs. Accordingly, for the reasons discussed above and in the proposed rule, we are finalizing the changes to § 478.44 as proposed without modification.
Current § 478.46(a) states that the Council will review an ALJ's hearing decision or dismissal under the same circumstances as those set forth at 20 CFR 404.970, which is now an outdated reference to SSA Appeals Council procedures for Council review. We proposed at § 478.46(a) to replace the outdated reference to 20 CFR 404.970
We received no comments on these proposals, other than comments discussed in section II.A.2 of this final rule above related to our general proposals to provide authority for attorney adjudicators to issue certain decisions, dismissals and remands, and to revise the rules so that decisions and dismissals issued by attorney adjudicators may be reopened and/or appealed in the same manner as equivalent decisions and dismissals issued by ALJs. Accordingly, for the reasons discussed above and in the proposed rule, we are finalizing the changes to § 478.46 as proposed without modification.
The title of current § 478.48 references reopenings and revisions of reconsidered determinations and hearing decisions, and current § 478.48 has an outdated reference to subpart G of 42 CFR part 405 for the procedures for reopening a decision by an ALJ or the DAB.
We proposed to revise the title of § 478.48 to replace “hearing decision” with “decision,” and in proposed paragraphs (b) and (c) to replace “ALJ” with “ALJ or attorney adjudicator” so the provision is understood to apply to decisions by ALJs, regardless of whether a hearing was conducted, or, as proposed in section II.B of the proposed rule (and discussed in section II.A.2 above), attorney adjudicators, as well as review decisions, which are conducted by the Council at the DAB. We also proposed at § 478.48(b) to replace the outdated reference to § 405.750(b), which was part of the now removed part 405, subpart G (77 FR 29016 through 29018), with § 405.980, which is the current part 405, subpart I reopening provision. 81 FR 43790, 43855.
We received no comments on these proposals, other than comments discussed in section II.A.2 of this final rule above related to our general proposals to provide authority for attorney adjudicators to issue certain decisions, dismissals and remands, and to revise the rules so that decisions and dismissals issued by attorney adjudicators may be reopened and/or appealed in the same manner as equivalent decisions and dismissals issued by ALJs. Accordingly, for the reasons discussed above and in the proposed rule, we are finalizing the changes to § 478.48 as proposed without modification.
In accordance with 5 U.S.C. 553(d) and section 1871 of the Act, publication of a final rule may be made not less than 30 days before its effective date. We are making this final rule effective 60 days after publication in the
Although we did not solicit comment on the effective date of the final rule, we did receive one comment on the subject. Provided below is a summary of that comment, along with our response to the comment and further details about the effective date and applicability of the final appeals provisions.
While the provisions of this final rule are effective with the effective date of this final rule, we recognize that there is currently a large volume of pending appeals at the OMHA and Council levels that were filed before the effective date of the final rule and are at various stages of the adjudication process, and it may be unclear how these final provisions will apply in those instances—and in a manner that avoids retroactive application. The provisions of this final rule will apply prospectively to all appeals, but specific provisions will not be applied to pending appeals filed before the effective date of the final rule in which certain actions or stages of the appeals process have already taken place prior to the effective date. For example, a revised requirement regarding the contents of a request for hearing is effective with the effective date of this final rule, but the requirement would not be applicable in a pending appeal if the hearing request was already filed prior to the effective date of this final rule (that is, the hearing request would not have to be re-filed to include the new contents of the request finalized in this rule). But for other appeals that are pending prior to the effective date of this final rule, provisions of this final rule may be applicable if a particular action or procedural step in those appeals has not yet taken place (for example, a revised final requirement regarding scheduling and sending notice of a hearing would apply if the hearing has not yet been scheduled and the notice of hearing has not yet been sent in a pending appeal).
Accordingly, the revised appeal procedures of this final rule are effective on the effective date of the final rule for all appeals filed on or after the effective date of the final rule, and appeals that were filed, but not decided, dismissed or remanded, prior to the effective date of the final rule. However, with regard to appeals that were filed, but not decided, dismissed or remanded, prior to the effective date of the final rule, we have provided a list of provisions in the table below as examples to help clarify how the revised rules will apply depending upon whether certain actions or procedures in such appeals have taken place as of the effective date of the
In response to the proposed rule, some commenters chose to raise issues that are beyond the scope of our proposals. In this final rule, we are generally not summarizing or responding to those comments in this document. However, we will review the comments and consider whether to take other actions, such as revising or clarifying CMS program operating instructions or procedures, based on the information or recommendations in the comments. In a few instances, commenters captioned their comments indicating they were submitted in response to a particular proposal, but the comment was nevertheless outside the scope of the proposed rule. In these instances, we briefly summarized the comments in section II of this final rule above, in the appropriate subsection addressing the particular proposal.
For the most part, this final rule incorporates the provisions of the proposed rule. The provisions of this final rule that differ from the proposed rule are as follows:
• In response to public comment, we added the following language to § 401.109(a) to include the general criteria the DAB Chair may consider when selecting a Council decision as precedential: “In determining which decisions should be designated as precedential, the DAB Chair may take into consideration decisions that address, resolve, or clarify recurring legal issues, rules or policies, or that may have broad application or impact, or involve issues of public interest.” We also added a parenthetical to indicate that the term “DAB Chair” is short for the Chair of the Department of Health and Human Services Departmental Appeals Board.
• For consistency with the rest of part 405, subpart I, and because the terms “ALJ” and “Council” are already defined in § 405.902, we removed “Administrative Law Judge (ALJ)” and “Medicare Appeals Council (Council)” from § 405.904(a)(1) and added “ALJ” and “Council” in their place, respectively.
• For consistency with § 405.1038, we removed language that we inadvertently included in § 405.1000(g) that is not consistent with the language in § 405.1038(a) as finalized in this rule. We revised § 405.1000(g) to state that “An ALJ or attorney adjudicator may also issue a decision on the record on his or her own initiative if the evidence in the administrative record supports a fully favorable finding for the appellant, and no other party to the appeal is liable for the claims at issue, unless CMS or a contractor has elected to be a party to the hearing in accordance with § 405.1012.”
• In response to public comment, we did not finalize our proposal at § 405.1006(d)(2)(i)(A) to use the Medicare allowable amount to calculate the amount in controversy for items and services that are priced based on a published Medicare fee schedule or published contractor-priced amount. In addition, we did not finalize § 405.1006(d)(2)(i)(B) because, given that we did not finalize § 405.1006(d)(2)(i)(A), there was no longer a need to distinguish between items and services with and without a published Medicare fee schedule or contractor-priced amount. We also did not finalize proposed § 405.1006(d)(2) and (d)(2)(i) introductory text or proposed § 405.1006(d)(1) introductory text. Accordingly, we maintained the text of current § 405.1006(d)(1), except that we: (1) Added “In general” as a paragraph heading, as proposed; (2) replaced “for the items and services in question” with “for the items and services in the disputed claim” in § 405.1006(d)(1) introductory text, as proposed; and (3) replaced “Any deductible and coinsurance amounts applicable in the particular case” in current § 405.1006(d)(1)(ii) with “Any deductible and/or coinsurance amounts that may be collected for the items or services,” as proposed. In addition, we also did not finalize our proposal to revise and re-designate current § 405.1006(d)(2) as § 405.1006(d)(3), except for the proposal to add “Limitation on liability” as a paragraph heading. However, for consistency with paragraph (d)(1)(ii), as finalized, we replaced “any deductible and coinsurance amounts applicable in the particular case” in current § 405.1006(d)(2) with “any deductible and/or coinsurance amounts that may be collected for the items or services.” We also did not finalize proposed § 405.1006(d)(2)(ii) and (iii).
• We finalized proposed § 405.1006 paragraphs (d)(4), (5), (6), and (7) with the modifications discussed below, but re-designated them as paragraphs (d)(3), (4), (5), and (6), respectively, because we did not finalize proposed § 405.1006(d)(2) or re-designate current § 405.1006(d)(2) as § 405.1006(d)(3). We replaced “in accordance with paragraphs (d)(1) and (d)(2)(ii) of this section, except that the basis for the amount in controversy” in paragraph (d)(3) (proposed paragraph (d)(4)) with “in accordance with paragraph (d)(1) of this section, except that the amount charged to the individual.” In addition, we replaced “Notwithstanding paragraphs (d)(1) and (2) of this section” in paragraphs (d)(4), (5), and (6) (proposed paragraphs (d)(5), (6), and (7)) with “Notwithstanding paragraph (d)(1) of this section.”
• We corrected a drafting error in the text of proposed § 405.1010(c)(3)(i) by replacing “by within 14 calendar days” with “within 14 calendar days.”
• In response to public comment, we added a requirement in §§ 405.1010(c)(3)(ii), 405.1012(c)(2)(ii) and 423.2010(d)(3)(ii) that copies of position papers and/or written testimony (and for purposes of § 405.1012(c)(2)(ii), any evidence) submitted to OMHA must be sent to the other parties within the same time frames that apply to the submissions to OMHA.
• We added language to § 405.1010(d)(3) to provide that CMS or a contractor that is precluded from participating in the oral hearing may still be called as a witness by CMS or a contractor that is a party to the hearing in accordance with § 405.1012. In light of this change, we also made a corresponding revision to § 405.1010(c)(2) to state that when CMS or its contractor participates in an ALJ hearing, CMS or its contractor may not be called as a witness during the hearing and is not subject to examination or cross-examination by the parties, except as provided in § 405.1010(d)(3).
• We clarified in § 405.1012(a)(2) that an ALJ may not request that CMS and/or one or more of its contractors be a party to the hearing if the request for hearing was filed by an unrepresented beneficiary.
• In response to public comment, we did not finalize our proposals at §§ 405.1014(a)(1)(vii) and 423.2014(a)(1)(vii), which would have required that the request for hearing contain a statement of whether the filing party is aware that it or the claim is the subject of an investigation or proceeding by OIG or other law enforcement agencies.
• In response to public comment, we did not finalize our proposal at § 405.1014(a)(1)(viii), which would have required that, for requests filed by providers, suppliers, Medicaid State agencies, applicable plans, or a beneficiary who is represented by a provider, supplier or Medicaid State agency, the request for hearing must include the amount in controversy applicable to the disputed claim determined in accordance with § 405.1006, unless the matter involves a provider or supplier termination of
• We removed the term “entity office,” which was a drafting error, from proposed § 405.1014(c)(2) and added “office” in its place.
• We clarified §§ 405.1014(c)(2) and 423.2014(d)(2)(i) to state that if the request for hearing is timely filed with an office other than the office specified in the QIC's reconsideration, the request is not treated as untimely.
• We revised 405.1014(d)(3) to state that unrepresented beneficiaries are exempt from the potential consequences of failing to send a copy of the request, materials, and/or evidence or summary thereof to the other parties.
• We corrected a drafting error by adding a missing comma to § 423.2018(b)(1) and (c)(1) for consistency with § 405.1018(a) and to clarify that there are three time frames when a represented enrollee may submit written or other evidence he or she wishes to have considered: (1) With the request for hearing; (2) by the date specified in the request for hearing in accordance with § 423.2014(a)(2); or (3) if a hearing is scheduled, within 10 calendar days (or 3 calendar days for expedited Part D appeals) of receiving the notice of hearing.
• We revised § 405.1018(d) to provide in paragraph (d)(1) that the requirements in paragraphs (a) and (b) do not apply to oral testimony given at a hearing or to evidence submitted by unrepresented beneficiaries, and in (d)(2) that the requirement in paragraph (c) to support new evidence with a statement of good cause does not apply to oral testimony given at a hearing or to evidence submitted by an unrepresented beneficiary, CMS or any of its contractors, a Medicaid State agency, an applicable plan, or a beneficiary represented by someone other than a provider or supplier.
• We revised § 405.1020(c)(1) to state that the notice of hearing is also sent to CMS or any contractor that has elected to participate in the proceedings in accordance with § 405.1010(b).
• Because we proposed to adopt in § 423.2020(b)(2) the same revisions as in § 405.1020(b)(2), we revised § 423.2020(b)(2)(ii)(A) to state “video-teleconferencing and telephone technology are not available,” rather than “video-teleconferencing or telephone technology is not available,” for consistency with § 405.1020(b)(2)(ii)(A) as finalized.
• In response to public comment, we revised §§ 405.1030(b)(2) and 423.2030(b)(2) to provide that the ALJ may limit testimony and/or argument at the hearing that are not relevant to an issue before the ALJ, that are repetitive of evidence or testimony already in the record, or that relate to an issue that has been sufficiently developed or on which the ALJ has already ruled.
• In response to public comment, we revised §§ 405.1030(b)(3) and 423.2030(b)(3) to clarify that a party or party's representative (or enrollee or enrollee's representative in the context of § 423.2030(b)(3)) may be excused from a hearing if that individual remains uncooperative, disruptive to the hearing, or abusive during the course of the hearing after the ALJ has warned the party or representative to stop such behavior.
• We revised §§ 405.1034(a)(1) and 423.2034(a)(1) to provide that OMHA will confirm whether an electronic copy of the redetermination or reconsideration is available in the official system of record prior to issuing a request for that information to the QIC or IRE and if so, will accept the electronic copy as the official copy. We also replaced “can only be provided by CMS, the IRE, and/or the Part D plan sponsor” in proposed § 423.2034(a)(1), which was a drafting error, with “can be provided only by CMS, the IRE, and/or the Part D plan sponsor,” for consistency with the definition in § 423.2034(a)(2).
• We revised § 405.1038(c) to provide that if the amount of payment is an issue before the ALJ or attorney adjudicator, a stipulated decision may be made if the statement from CMS or its contractor agrees to the amount of payment the party believes should be made. We made a corresponding change to § 423.2038(c) for stipulated decisions in part 423, subpart U proceedings.
• We revised § 405.1052(a)(7) and (b)(4) to provide that a request for hearing or a request for review of a QIC dismissal filed by an unrepresented beneficiary will not be dismissed if the appellant fails to send a copy of the request to the other parties in accordance with proposed § 405.1014(d).
• We revised §§ 405.1056(g) and 423.2056(g) to add language to specifically exempt remands that are issued on a review of a QIC's or IRE's dismissal of a request for reconsideration from potential review by the Chief ALJ or designee.
• We corrected a drafting error in proposed § 405.1110(b)(2) by removing two references to a “hearing decision” under § 405.1046(a) and replacing them with “decision,” because § 405.1046(a) as finalized in this rule also addresses decisions issued by an ALJ or attorney adjudicator when a hearing is not held.
• We revised §§ 422.562(d) and 478.40(c) to specify in greater detail those part 405 provisions that implement specific sections of section 1869 of the Act that are not also included in sections 1852 and 1155 of the Act, and that we do not believe apply to part 422, subpart M or part 478, subpart B adjudications. Specifically, we are revising these regulations to provide that the following regulations in part 405, and any references thereto, do not apply to proceedings under part 422, subpart M or part 478, subpart B: (1) § 405.950 (time frames for making a redetermination); (2) § 405.970 (time frames for making a reconsideration following a contractor redetermination, including the option to escalate an appeal to the OMHA level); (3) § 405.1016 (time frames for deciding an appeal of a QIC reconsideration or escalated request for a QIC reconsideration, including the option to escalate an appeal to the Council); (4) The option to request that an appeal be escalated from the OMHA level to the Council as provided in § 405.1100(b) and the time frame for the Council to decide an appeal of an ALJ's or attorney adjudicator's decision or an appeal that is escalated from the OMHA level to the Council as provided in § 405.1100(c) and (d); (5) § 405.1132 (request for escalation to Federal court); and (6) §§ 405.956(b)(8), 405.966(a)(2), 405.976(b)(5)(ii), 405.1018(c), 405.1028(a), and 405.1122(c), and any other references to requiring a determination of good cause for the introduction of new evidence by a provider, supplier, or a beneficiary represented by a provider or supplier.
• We revised the second sentence of § 422.608 to reference § 422.562(d), such that this sentence states, “The regulations under part 405 of this chapter regarding Council review apply to matters addressed by this subpart to the extent they are appropriate, except as provided in § 422.562(d)(2).”
• For consistency with the title of part 423, subpart U as finalized, the revisions finalized related to attorney adjudicator reviews, and the revisions finalized to replace references to “MAC” with “Council,”, we made technical conforming revisions to § 423.558(b) replace the reference to “MAC” with “Council” and the reference to “ALJ hearings” with “ALJ hearings and ALJ and attorney adjudicator decisions.” We also made a technical edit to replace “Judicial review” with “judicial review.”
Under the Paperwork Reduction Act of 1995, we are required to provide 30-day notice in the
• The need for the information collection and its usefulness in carrying out the proper functions of our agency.
• The accuracy of our estimate of the information collection burden.
• The quality, utility, and clarity of the information to be collected.
• Recommendations to minimize the information collection burden on the affected public, including automated collection techniques.
We solicited public comment on each of these issues for the following sections of this document that contain information collection requirements (ICRs):
The PRA exempts most of the information collection activities referenced in this final rule. In particular, the implementing regulations of the PRA at 5 CFR 1320.4 exclude collection activities during the conduct of a civil action to which the United States or any official or agency thereof is a party. Civil actions include administrative actions such as redeterminations, reconsiderations, and/or appeals. Specifically, these actions are taken after the initial determination or a denial of payment, or MAO organization determination or Part D plan sponsor coverage determination. However, one requirement contained in this final rule is subject to the PRA because the burden is imposed prior to an administrative action or denial of payment. This requirement is discussed below.
In summary, § 405.910 requires that when a provider or supplier is the party appointing a representative, the appointment of representation would include the Medicare National Provider Identifier (NPI) of the provider or supplier that furnished the item of service. Although this is a new regulatory requirement, the current Medicare Claims Processing Manual already states that the NPI should be included when a provider or supplier appoints a representative. The standardized form for appointing a representative, Form CMS-1696, currently provides a space for the information in question. Importantly, this form is currently approved under OMB control number 0938-0950 and expires June 30, 2018.
The burden associated with this requirement is the time and effort of an individual or entity who is a provider or supplier to prepare an appointment of representation containing the NPI. As stated earlier, this requirement and the related burden are subject to the PRA; however, because we believe that this information is already routinely being collected, we estimate there would be no additional burden for completing an appointment of representative in accordance with § 405.910.
If you wish to view the standardized form and the supporting documentation, you can download a copy from the CMS Web site at
We have submitted a copy of this final rule to OMB for its review of the information collection requirements described above.
If you wish to comment on these information collection, that is, reporting, recordkeeping or third-party disclosure requirements, please submit your comments to the Office of Information and Regulatory Affairs, Office of Management and Budget, Attention: CMS Desk Officer, HHS-2016-79, Fax: (202) 395-6974; or Email:
We have examined the impacts of this final rule as required by Executive Order 12866 on Regulatory Planning and Review (September 30, 1993), Executive Order 13563 on Improving Regulation and Regulatory Review (January 18, 2011), the Regulatory Flexibility Act (RFA) (September 19, 1980, Pub. L. 96-354), section 1102(b) of the Social Security Act, section 202 of the Unfunded Mandates Reform Act of 1995 (March 22, 1995; Pub. L. 104-4), Executive Order 13132 on Federalism (August 4, 1999) and the Congressional Review Act (5 U.S.C. 804(2)).
Executive Orders 12866 and 13563 direct agencies to assess all costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, distributive impacts, and equity). A regulatory impact analysis (RIA) must be prepared for major rules with economically significant effects ($100 million or more in any 1 year). We have determined that the effect of this final rule does not reach this economic threshold and thus is not considered a major rule. As detailed above, this final rule would only make minimal changes to the existing Medicare appeals procedures for claims for benefits under or entitlement to the original Medicare programs, and coverage of items, services, and drugs under the MA and voluntary Medicare prescription drug programs. Thus, this final rule would have negligible financial impact on beneficiaries and enrollees, providers or suppliers, Medicare contractors, MAOs, and Part D plan sponsors, but would derive benefits to the program and appellants.
HHS recognizes that the current appeals backlog is a matter of great significance, and it has made it a priority to adopt measures that are designed to reduce the backlog and improve the overall Medicare appeals process. To that end, HHS has initiated a series of measures, including this final regulation, that are aimed at both reducing the backlog and creating a more efficient Medicare appeals system.
We believe the changes in this regulation will help address the Medicare appeals backlog and create efficiencies at the ALJ level of appeal by allowing OMHA to reassign a portion of workload to non-ALJ adjudicators and reduce procedural ambiguities that result in unproductive efforts at OMHA and unnecessary appeals to the Medicare Appeals Council. In addition, the other changes, including precedential decisions and generally limiting CMS and CMS contractor participation or party status at the OMHA level unless the ALJ determines participation by additional entities is necessary for a full examination of the matters at issue (as provided in proposed §§ 405.1010(d) and 405.1012(d)), will collectively make the ALJ hearing process more efficient through streamlined and standardized procedures and more consistent decisions, and reduce appeals to the Medicare Appeals Council.
In particular, we are able to estimate the impact from one of the changes—the expansion of the pool of adjudicators. Based on FY 2016, and an assumption that future years are similar to FY 2016, we estimate that the expansion of the pool of adjudicators at OMHA could redirect approximately 24,500 appeals per year to attorney adjudicators who would be able to process these appeals at a lower cost than would be required if only ALJs were used to address the same workload. If in future years the number of requests for hearing, waivers of oral hearing, requests for review of a contractor dismissal, or appellant
In the proposed rule, we also estimated that the proposed modifications to calculating the amount in controversy required for an ALJ hearing could potentially remove appeals related to over 2,600 Part B low-value claims per year from the ALJ hearing process, after accounting for the likelihood of appellants aggregating claims to meet the AIC. 81 FR 43790, 43856. However, as discussed in section II.B.3.d of this final rule above, we are not finalizing our proposal under § 405.1006(d)(2)(i)(A) to use the Medicare allowable amount as the basis for the amount in controversy for items and services that are priced based on a published Medicare fee schedule or published contractor-priced amount. Although we are finalizing separate calculations of the amount in controversy to address the situations in proposed § 405.1006(d)(3) through (7), we do not expect these provisions will have a meaningful effect on the number of appeals eligible for an ALJ hearing.
The Regulatory Flexibility Act (5 U.S.C. 601
For purposes of the RFA, most providers and suppliers are small entities, either by nonprofit status or by having revenues of less than $7.5 million to $38.5 million in any one year. In addition, a number of MAOs and Part D plan sponsors (insurers) are small entities due to their nonprofit status; however, few if any meet the SBA size standard for a small insurance firm by having revenues of $38.5 million or less in any one year. Individuals and States are not included in the definition of a small entity. We have determined and we certify that this final rule would not have a significant economic impact on a substantial number of small entities because as noted above, this final rule makes only minimal changes to the existing appeals procedures. Therefore, we did not prepare an analysis for the RFA.
In addition, section 1102(b) of the Act requires us to prepare a regulatory impact analysis (RIA) if a rule may have a significant impact on the operations of a substantial number of small rural hospitals. For final rules, this analysis must conform to the provisions of section 604 of the RFA. For purposes of section 1102(b) of the Act, we define a small rural hospital as a hospital that is located outside of a Metropolitan Statistical Area for Medicare payment regulations and has fewer than 100 beds. We have determined that this final rule would not have a significant effect on the operations of a substantial number of small rural hospitals. As noted above, this final rule makes only minimal changes to the existing appeals procedures and thus, would not have a significant impact on small entities or the operations of a substantial number of small rural hospitals. Therefore, we did not prepare an analysis for section 1102(b) of the Act.
Section 202 of the Unfunded Mandates Reform Act of 1995 also requires that agencies assess anticipated costs and benefits before issuing any rule that would include any Federal mandate that may result in expenditure in any one year by State, local, or Tribal governments, in the aggregate, or by the private sector, of $100 million in 1995 dollars, updated annually for inflation. Currently, that threshold is approximately $146 million. This final rule would not impose spending costs on State, local, or tribal governments in the aggregate, or on the private sector in the amount of $146 million in any one year, because as noted above, this final rule makes only minimal changes to the existing appeals procedures.
Executive Order 13132 on Federalism establishes certain requirements that an agency must meet when it publishes a proposed rule and subsequent final rule that imposes substantial direct requirement costs on State and local governments, preempts State law, or otherwise has Federalism implications. This final rule does not impose substantial direct requirement costs on State or local governments, preempt State law, or otherwise implicate Federalism.
In accordance with the provisions of Executive Order 12866, this regulation was reviewed by the Office of Management and Budget.
Claims, Freedom of information, Health facilities, Medicare, Privacy.
Administrative practice and procedure, Health facilities, Health professions, Kidney diseases, Medical devices, Medicare, Reporting and recordkeeping requirements, Rural areas, X-rays.
Administrative practice and procedure, Health facilities, Health maintenance organizations (HMO), Medicare, Penalties, Privacy, and Reporting and recordkeeping requirements.
Administrative practice and procedure, Emergency medical services, Health facilities, Health maintenance organizations (HMO), Health professionals, Medicare, Penalties, Privacy, Reporting and recordkeeping requirements.
Administrative practice and procedure, Health care, Health professions, Peer Review Organizations (PRO), Reporting and recordkeeping requirements.
For the reasons set forth in the preamble, the Department of Health and Human Services amends 42 CFR chapter IV as set forth below:
Secs. 1102, 1871, and 1874(e) of the Social Security Act (42 U.S.C. 1302, 1395hh, and 1395w-5).
(a) The Chair of the Department of Health and Human Services Departmental Appeals Board (DAB Chair) may designate a final decision of the Secretary issued by the Medicare Appeals Council in accordance with part 405, subpart I; part 422, subpart M; part 423, subpart U; or part 478, subpart B, of this chapter as precedential. In determining which decisions should be designated as precedential, the DAB Chair may take into consideration
(b) Precedential decisions are made available to the public, with personally identifiable information of the beneficiary removed, and have precedential effect from the date they are made available to the public. Notice of precedential decisions is published in the
(c) Medicare Appeals Council decisions designated in accordance with paragraph (a) of this section have precedential effect and are binding on all CMS components, on all HHS components that adjudicate matters under the jurisdiction of CMS, and on the Social Security Administration to the extent that components of the Social Security Administration adjudicate matters under the jurisdiction of CMS.
(d) Precedential effect, as used in this section, means that the Medicare Appeals Council's—
(1) Legal analysis and interpretation of a Medicare authority or provision is binding and must be followed in future determinations and appeals in which the same authority or provision applies and is still in effect; and
(2) Factual findings are binding and must be applied to future determinations and appeals involving the same parties if the relevant facts are the same and evidence is presented that the underlying factual circumstances have not changed since the issuance of the precedential final decision.
Secs. 205(a), 1102, 1861, 1862(a), 1869, 1871, 1874, 1881, and 1886(k) of the Social Security Act (42 U.S.C. 405(a), 1302, 1395x, 1395y(a), 1395ff, 1395hh, 1395kk, 1395rr and 1395ww(k)), and sec. 353 of the Public Health Service Act (42 U.S.C. 263a).
The additions read as follows:
(a) * * *
(1)
(2)
The additions and revisions read as follows:
(c) * * *
(5) Identify the beneficiary's Medicare health insurance claim number when the beneficiary is the party appointing a representative, or identify the Medicare National Provider Identifier number of the provider or supplier that furnished the item or service when the provider or supplier is the party appointing a representative;
(d) * * *
(3) If an adjudication time frame applies, the time from the later of the date that a defective appointment of representative was filed or the current appeal request was filed by the prospective appointed representative, to
(f) * * *
(1)
(i) * * *
(2)
(3) The contractor, QIC, ALJ or attorney adjudicator, or Council sends any requests for information or evidence regarding a claim that is appealed to the appointed representative. The contractor sends any requests for information or evidence regarding an initial determination to the party.
(l)
(i) The appointed representative provides written notice to the party of the appointed representative's intent to delegate to another individual, which contains the name of the designee and the designee's acceptance to be obligated by and comply with the requirements of representation under this subpart; and
(ii) The party accepts the designation as evidenced by a written statement signed by the party. The written statement signed by the party is not required when the appointed representative and designee are attorneys in the same law firm or organization and the notice described in paragraph (l)(1)(i) of this section so indicates.
(2) A delegation is not effective until the adjudicator receives a copy of the acceptance described in paragraph (l)(1)(ii) of this section, unless the appointed representative and designee are attorneys in the same law firm or organization, in which case the notice described in paragraph (l)(1)(i) of this section may be submitted even though the acceptance described in paragraph (l)(1)(ii) of this section is not required.
(3) A party's or representative's failure to notify the adjudicator that an appointment of representative has been delegated is not good cause for missing a deadline or not appearing at a hearing.
(m) * * *
(4) A party's or representative's failure to notify the adjudicator that an appointment of representative has been revoked is not good cause for missing a deadline or not appearing at a hearing.
(l) A contractor's, QIC's, ALJ's or attorney adjudicator's, or Council's determination or decision to reopen or not to reopen an initial determination, redetermination, reconsideration, decision, or review decision.
(m) Determinations that CMS or its contractors may participate in the proceedings on a request for an ALJ hearing or act as parties in an ALJ hearing or Council review.
(b) * * *
(1) National coverage determinations (NCDs), CMS Rulings, Council decisions designated by the Chair of the Departmental Appeals Board as having precedential effect under § 401.109 of this chapter, and applicable laws and regulations are binding on the QIC.
(a)
(b)
(2) If a QIC receives timely requests for reconsideration following a contractor redetermination from multiple parties, consistent with § 405.964(c), the QIC must issue a reconsideration, notice that it cannot complete its review, or dismissal within 60 calendar days for each submission of the latest filed request.
(3) Each time a party submits additional evidence after the request for reconsideration following a contractor redetermination is filed, the QIC's 60 calendar day decisionmaking timeframe is extended by up to 14 calendar days for each submission, consistent with § 405.966(b).
(c)
(e) * * *
(1) If the appellant fails to notify the QIC, or notifies the QIC that the appellant does not choose to escalate the case, the QIC completes its reconsideration following a contractor redetermination and notifies the appellant of its action consistent with § 405.972 or § 405.976.
(2) * * *
(i) Complete its reconsideration following a contractor redetermination and notify all parties of its decision consistent with § 405.972 or § 405.976.
(ii) Acknowledge the escalation notice in writing and forward the case file to OMHA.
The revision reads as follows:
(b)
(3) A QIC's review of a contractor's dismissal of a redetermination request is binding and not subject to further review.
The revision reads as follows:
(b) * * *
(7) A statement of whether the amount in controversy is estimated to meet or not meet the amount required for an ALJ hearing, if—
(i) The request for reconsideration was filed by a beneficiary who is not represented by a provider, supplier, or Medicaid State agency; and
(ii) The reconsideration decision is partially or fully unfavorable.
(a) * * *
(1) * * *
(iii) An ALJ or attorney adjudicator to revise his or her decision; or
(iv) The Council to revise the ALJ or attorney adjudicator decision, or its review decision.
(4) When a party has filed a valid request for an appeal of an initial determination, redetermination, reconsideration, ALJ or attorney adjudicator decision, or Council review, no adjudicator has jurisdiction to reopen an issue on a claim that is under appeal until all appeal rights for that issue are exhausted. Once the appeal rights for the issue have been exhausted, the contractor, QIC, ALJ or attorney adjudicator, or Council may reopen as set forth in this section.
(5) The contractor's, QIC's, ALJ's or attorney adjudicator's, or Council's decision on whether to reopen is binding and not subject to appeal.
(d)
(2) An ALJ or attorney adjudicator may reopen his or her decision, or the Council may reopen an ALJ or attorney adjudicator decision on its own motion within 180 calendar days from the date of the decision for good cause in accordance with § 405.986. If the decision was procured by fraud or similar fault, then the ALJ or attorney adjudicator may reopen his or her decision, or the Council may reopen an ALJ or attorney adjudicator decision, at any time.
(3) The Council may reopen its review decision on its own motion within 180 calendar days from the date of the review decision for good cause in accordance with § 405.986. If the Council's decision was procured by fraud or similar fault, then the Council may reopen at any time.
(e)
(2) A party to an ALJ or attorney adjudicator decision may request that an ALJ or attorney adjudicator reopen his or her decision, or the Council reopen an ALJ or attorney adjudicator decision, within 180 calendar days from the date of the decision for good cause in accordance with § 405.986.
(3) A party to a Council review may request that the Council reopen its decision within 180 calendar days from the date of the review decision for good cause in accordance with § 405.986.
The revisions read as follows:
(d)
(e)
The revisions read as follows:
(d) * * *
(1)
(i) If a request for ALJ hearing or Council review is not pending, file a written EAJR request with the HHS Departmental Appeals Board with his or her request for an ALJ hearing or Council review; or
(ii) If an appeal is already pending for an ALJ hearing or otherwise before OMHA, or the Council, file a written EAJR request with the HHS Departmental Appeals Board.
(i) * * *
(1) If a request for EAJR does not meet all the conditions set out in paragraphs (b), (c) and (d) of this section, or if the review entity does not certify a request for EAJR, the review entity advises in writing all parties that the request has been denied, and forwards the request to OMHA or the Council, which will treat it as a request for hearing or for Council review, as appropriate.
(2) Whenever a review entity forwards a rejected EAJR request to OMHA or the Council, the appeal is considered timely filed, and if an adjudication time frame applies to the appeal, the adjudication time frame begins on the day the request is received by OMHA or the Council from the review entity.
(a) If a party is dissatisfied with a QIC's reconsideration, or if the adjudication period specified in § 405.970 for the QIC to complete its reconsideration has elapsed, the party may request a hearing before an ALJ.
(b) A hearing before an ALJ may be conducted in-person, by video-teleconference (VTC), or by telephone. At the hearing, the parties may submit evidence (subject to the restrictions in § 405.1018 and § 405.1028), examine the evidence used in making the determination under review, and present and/or question witnesses.
(c) In some circumstances, CMS or its contractor may participate in the proceedings under § 405.1010, or join the hearing before an ALJ as a party under § 405.1012.
(d) The ALJ or attorney adjudicator conducts a de novo review and issues a decision based on the administrative record, including, for an ALJ, any hearing record.
(e) If all parties who are due a notice of hearing in accordance with § 405.1020(c) waive their right to appear at the hearing in person or by telephone or video-teleconference, the ALJ or an attorney adjudicator may make a decision based on the evidence that is in the file and any new evidence that is submitted for consideration.
(f) The ALJ may require the parties to participate in a hearing if it is necessary to decide the case. If the ALJ determines that it is necessary to obtain testimony from a non-party, he or she may hold a hearing to obtain that testimony, even if all of the parties who are entitled to a notice of hearing in accordance with § 405.1020(c) have waived the right to appear. In that event, however, the ALJ will give the parties the opportunity to appear when the testimony is given, but may hold the hearing even if none of the parties decide to appear.
(g) An ALJ or attorney adjudicator may also issue a decision on the record on his or her own initiative if the evidence in the administrative record supports a fully favorable finding for the appellant, and no other party to the appeal is liable for the claims at issue, unless CMS or a contractor has elected to be a party to the hearing in accordance with § 405.1012.
(h) If more than one party timely files a request for hearing on the same claim before a decision is made on the first timely filed request, the requests are consolidated into one proceeding and record, and one decision, dismissal, or remand is issued.
(a) A party to a QIC's dismissal of a request for reconsideration has a right to have the dismissal reviewed by an ALJ or attorney adjudicator if—
(1) The party files a written request for review within 60 calendar days after receipt of the notice of the QIC's dismissal.
(4) For purposes of meeting the 60 calendar day filing deadline, the request is considered as filed on the date it is received by the office specified in the QIC's dismissal.
(b) If the ALJ or attorney adjudicator determines that the QIC's dismissal was in error, he or she vacates the dismissal and remands the case to the QIC for a reconsideration in accordance with § 405.1056.
(c) If the ALJ or attorney adjudicator affirms the QIC's dismissal of a reconsideration request, he or she issues a notice of decision affirming the QIC dismissal in accordance with § 405.1046(b).
(d) The ALJ or attorney adjudicator may dismiss the request for review of a QIC's dismissal in accordance with § 405.1052(b).
The revisions and additions read as follows:
(d) * * *
(1)
(ii) Any deductible and/or coinsurance amounts that may be collected for the items or services.
(2)
(3)
(4)
(5)
(6)
(e) * * *
(1)
(ii) The appellant(s) requests aggregation of claims appealed in the same request for ALJ hearing, or in multiple requests for an ALJ hearing filed with the same request for aggregation, and the request is filed within 60 calendar days after receipt of all of the reconsiderations being appealed; and
(iii) The claims that a single appellant seeks to aggregate involve the delivery of similar or related services, or the claims that multiple appellants seek to aggregate involve common issues of law and fact, as determined by an ALJ or attorney adjudicator. Only an ALJ may determine the claims that a single appellant seeks to aggregate do not involve the delivery of similar or related services, or the claims that multiple appellants seek to aggregate do not involve common issues of law and fact. Part A and Part B claims may be combined to meet the amount in controversy requirements.
(2)
(ii) The appellant(s) requests aggregation of the claims for an ALJ hearing in the same request for escalation; and
(iii) The claims that a single appellant seeks to aggregate involve the delivery of similar or related services, or the claims that multiple appellants seek to aggregate involve common issues of law and fact, as determined by an ALJ or attorney adjudicator. Only an ALJ may determine the claims that a single appellant seeks to aggregate do not involve the delivery of similar or related services, or the claims that multiple appellants seek to aggregate do not involve common issues of law and fact. Part A and Part B claims may be combined to meet the amount in controversy requirements.
The party who filed the request for hearing and all other parties to the reconsideration are parties to the proceedings on a request for an ALJ hearing. In addition, a representative of CMS or its contractor may be a party under the circumstances described in § 405.1012.
(a)
(2) An ALJ may request, but may not require, CMS and/or one or more of its contractors to participate in any proceedings before the ALJ, including the oral hearing, if any. The ALJ cannot draw any adverse inferences if CMS or the contractor decides not to participate in any proceedings before the ALJ, including the hearing.
(b)
(2)
(3)
(i) If no hearing is scheduled, no later than 30 calendar days after notification that a request for hearing was filed; or
(ii) If a hearing is scheduled, no later than 10 calendar days after receiving the notice of hearing.
(c)
(2) When CMS or its contractor participates in an ALJ hearing, CMS or its contractor may not be called as a witness during the hearing and is not subject to examination or cross-examination by the parties, except as provided in paragraph (d)(3) of this section. However, the parties may provide testimony to rebut factual or policy statements made by a participant
(3) CMS or contractor position papers and written testimony are subject to the following:
(i) A position paper or written testimony must be submitted within 14 calendar days of an election to participate if no hearing has been scheduled, or no later than 5 calendar days prior to the hearing if a hearing is scheduled unless the ALJ grants additional time to submit the position paper or written testimony.
(ii) A copy of any position paper or written testimony it submits to OMHA must be sent within the same time frame specified in paragraph (c)(3)(i) of this section to—
(A) The parties who were sent a copy of the notice of reconsideration, if the position paper or written testimony is being submitted before receipt of a notice of hearing for the appeal; or
(B) The parties who were sent a copy of the notice of hearing, if the position paper or written testimony is being submitted after receipt of a notice of hearing for the appeal.
(iii) If CMS or a contractor fails to send a copy of its position paper or written testimony to the parties or fails to submit its position paper or written testimony within the time frames described in this paragraph, the position paper or written testimony will not be considered in deciding the appeal.
(d)
(2) If CMS or a contractor did not elect to be a party to a hearing in accordance with § 405.1012 and more than one entity elected to be a participant in the proceedings in accordance with this section, only the first entity to file a response to the notice of hearing as provided under § 405.1020(c) may participate in the oral hearing. Entities that filed a subsequent response to the notice of hearing may not participate in the oral hearing, but may file a position paper and/or written testimony to clarify factual or policy issues in the case.
(3) If CMS or a contractor is precluded from participating in the oral hearing under paragraph (d)(1) or (2) of this section, the ALJ may grant leave to the precluded entity to participate in the oral hearing if the ALJ determines that the entity's participation is necessary for a full examination of the matters at issue. If the ALJ does not grant leave to the precluded entity to participate in the oral hearing, the precluded entity may still be called as a witness by CMS or a contractor that is a party to the hearing in accordance with § 405.1012.
(e)
(2) If an election is determined to be invalid, a written notice must be sent to the entity that submitted the election and the parties who are entitled to receive notice of the election in accordance with this section.
(i) If no hearing is scheduled or the election was submitted after the hearing occurred, the written notice of invalid election must be sent no later than the date the notice of decision, dismissal, or remand is mailed.
(ii) If a hearing is scheduled, the written notice of invalid election must be sent prior to the hearing. If the notice would be sent fewer than 5 calendar days before the hearing is scheduled to occur, oral notice must be provided to the entity that submitted the election, and the written notice must be sent as soon as possible after the oral notice is provided.
(a)
(2) Unless the request for hearing is filed by an unrepresented beneficiary, an ALJ may request, but may not require, CMS and/or one or more of its contractors to be a party to the hearing. The ALJ cannot draw any adverse inferences if CMS or the contractor decides not to be a party to the hearing.
(b)
(c)
(2) CMS or contractor position papers, written testimony, and evidentiary submissions are subject to the following:
(i) Any position paper, written testimony, and/or evidence must be submitted no later than 5 calendar days prior to the hearing unless the ALJ grants additional time to submit the position paper, written testimony, and/or evidence.
(ii) A copy of any position paper, written testimony, and/or evidence it submits to OMHA must be sent within the same time frame specified in paragraph (c)(2)(i) of this section to the parties who were sent a copy of the notice of hearing.
(iii) If CMS or a contractor fails to send a copy of its position paper, written testimony, and/or evidence to the parties or fails to submit its position paper, written testimony, and/or evidence within the time frames described in this section, the position paper, written testimony, and/or evidence will not be considered in deciding the appeal.
(d)
(2) If CMS or a contractor filed an election to be a party in accordance with this section but is precluded from being made a party under paragraph (d)(1) of this section, the ALJ may grant leave to be a party to the hearing if the ALJ determines that the entity's participation as a party is necessary for a full examination of the matters at issue.
(e)
(2) If an election is determined to be invalid, a written notice must be sent to the entity that submitted the election and the parties who were sent the notice of hearing.
(i) If the election was submitted after the hearing occurred, the written notice of invalid election must be sent no later than the date the decision, dismissal, or remand notice is mailed.
(ii) If the election was submitted before the hearing occurs, the written notice of invalid election must be sent prior to the hearing. If the notice would be sent fewer than 5 calendar days before the hearing is scheduled to occur, oral notice must be provided to the entity that submitted the election, and the written notice to the entity and the parties who were sent the notice of hearing must be sent as soon as possible after the oral notice is provided.
(a)
(i) The name, address, and Medicare health insurance claim number of the beneficiary whose claim is being appealed, and the beneficiary's telephone number if the beneficiary is the appealing party and not represented.
(ii) The name, address, and telephone number, of the appellant, when the appellant is not the beneficiary.
(iii) The name, address, and telephone number, of the designated representative, if any.
(iv) The Medicare appeal number or document control number, if any, assigned to the QIC reconsideration or dismissal notice being appealed.
(v) The dates of service of the claim(s) being appealed, if applicable.
(vi) The reasons the appellant disagrees with the QIC's reconsideration or other determination being appealed.
(2) The appellant must submit a statement of any additional evidence to be submitted and the date it will be submitted.
(3) Special rule for appealing statistical sample and/or extrapolation. If the appellant disagrees with how a statistical sample and/or extrapolation was conducted, the appellant must—
(i) Include the information in paragraphs (a)(1) and (2) of this section for each sample claim that the appellant wishes to appeal;
(ii) File the request for hearing for all sampled claims that the appellant wishes to appeal within 60 calendar days of the date the party receives the last reconsideration for the sample claims, if they were not all addressed in a single reconsideration; and
(iii) Assert the reasons the appellant disagrees with how the statistical sample and/or extrapolation was conducted in the request for hearing.
(b)
(2) If supporting materials submitted with a request clearly provide information required for a complete request, the materials will be considered in determining whether the request is complete.
(c)
(1) Within 60 calendar days from the date the party receives notice of the QIC's reconsideration or dismissal, except as provided in paragraph (a)(3)(ii) of this section for appeals of extrapolations;
(2) With the office specified in the QIC's reconsideration or dismissal. If the request for hearing is timely filed with an office other than the office specified in the QIC's reconsideration, the request is not treated as untimely, and any applicable time frame specified in § 405.1016 for deciding the appeal begins on the date the office specified in the QIC's reconsideration or dismissal receives the request for hearing. If the request for hearing is filed with an office, other than the office specified in the QIC's reconsideration or dismissal, OMHA must notify the appellant of the date the request was received in the correct office and the commencement of any applicable adjudication time frame.
(d)
(2) Evidence that a copy of the request for hearing or request for review of a QIC dismissal, or a copy of submitted evidence or a summary thereof, was sent in accordance with paragraph (d)(1) of this section includes—
(i) Certification on the standard form for requesting an ALJ hearing or requesting a review of a QIC dismissal that a copy of the request is being sent to the other parties;
(ii) An indication, such as a copy or “cc” line, on a request for hearing or request for review of a QIC dismissal that a copy of the request and any applicable attachments or enclosures are being sent to the other parties, including the name and address of the recipient;
(iii) An affidavit or certificate of service that identifies the name and address of the recipient, and what was sent to the recipient; or
(iv) A mailing or shipping receipt that identifies the name and address of the recipient, and what was sent to the recipient.
(3) If the appellant, other than an unrepresented beneficiary, fails to send a copy of the request for hearing or request for review of a QIC dismissal, any additional materials, or a copy of submitted evidence or a summary thereof, as described in paragraph (d)(1) of this section, the appellant will be provided with an additional opportunity to send the request, materials, and/or evidence or summary thereof, and if an adjudication time frame applies, it begins upon receipt of evidence that the request, materials, and/or evidence or summary thereof were sent. If the appellant, other than an unrepresented beneficiary, again fails to provide evidence that the request, materials, and/or evidence or summary thereof were sent within the additional time frame provided to send the request, materials, and/or evidence or summary thereof, the appellant's request for hearing or request for review of a QIC dismissal will be dismissed.
(e)
(2) Any request for an extension of time must be in writing, give the reasons why the request for a hearing or review was not filed within the stated time period, and must be filed with the request for hearing or request for review of a QIC dismissal with the office specified in the notice of reconsideration or dismissal.
(3) An ALJ or attorney adjudicator may find there is good cause for missing the deadline to file a request for an ALJ hearing or request for review of a QIC dismissal, or there is no good cause for missing the deadline to file a request for a review of a QIC dismissal, but only an ALJ may find there is no good cause for missing the deadline to file a request for an ALJ hearing. If good cause is found for missing the deadline, the time period for filing the request for hearing or request for review of a QIC dismissal will be extended. To determine whether good cause for late filing exists, the ALJ or attorney adjudicator uses the standards set forth in § 405.942(b)(2) and (3).
(4) If a request for hearing is not timely filed, any applicable adjudication period in § 405.1016 begins the date the ALJ or attorney adjudicator grants the request to extend the filing deadline.
(5) A determination granting a request to extend the filing deadline is not subject to further review.
(a)
(b)
(2) If the Council remands a case and the case was subject to an adjudication time frame under paragraph (a) or (c) of this section, the remanded appeal will be subject to the adjudication time frame of paragraph (a) of this section beginning on the date that OMHA receives the Council remand.
(c)
(d)
(2) The adjudication periods specified in paragraphs (a) and (c) of this section are extended as otherwise specified in this subpart, and for the following events—
(i) The duration of a stay of action on adjudicating the claims or matters at issue ordered by a court or tribunal of competent jurisdiction; or
(ii) The duration of a stay of proceedings granted by an ALJ or attorney adjudicator on a motion by an appellant, provided no other party also filed a request for hearing on the same claim at issue.
(e)
(f)
(2)
(i) Send a notice to the appellant stating that an ALJ or attorney adjudicator is not able to issue a decision, dismissal order, or remand order within the adjudication period set forth in paragraph (a) or (c) of this section, the QIC reconsideration will be the decision that is subject to Council review consistent with § 405.1102(a), and the appeal will be escalated to the Council for a review in accordance with § 405.1108; and
(ii) Forward the case file to the Council.
(3)
(a)
(b)
(c)
(2) If a statement explaining why the evidence was not previously submitted to the QIC or a prior decision-maker is not included with the evidence, the evidence will not be considered.
(d)
(2) The requirements in paragraph (c) of this section do not apply to oral testimony given at a hearing, or to evidence submitted by an unrepresented beneficiary, CMS or any of its contractors, a Medicaid State agency, an applicable plan, or a beneficiary represented by someone other than a provider or supplier.
The revisions and additions read as follows:
(b)
(i) The ALJ may also offer to conduct a hearing by telephone if the request for hearing or administrative record suggests that a telephone hearing may be more convenient for the unrepresented beneficiary.
(ii) The ALJ, with the concurrence of the Chief ALJ or designee, may find good cause that an in-person hearing should be conducted if—
(A) VTC or telephone technology is not available; or
(B) Special or extraordinary circumstances exist.
(2)
(i) The ALJ may find good cause for an appearance by VTC if he or she determines that VTC is necessary to examine the facts or issues involved in the appeal.
(ii) The ALJ, with the concurrence of the Chief ALJ or designee, also may find good cause that an in-person hearing should be conducted if—
(A) VTC and telephone technology are not available; or
(B) Special or extraordinary circumstances exist.
(c)
(2) The notice of hearing will require all parties to the ALJ hearing to reply to the notice by:
(i) Acknowledging whether they plan to attend the hearing at the time and place proposed in the notice of hearing, or whether they object to the proposed time and/or place of the hearing;
(ii) If the party or representative is an entity or organization, specifying who from the entity or organization plans to attend the hearing, if anyone, and in what capacity, in addition to the individual who filed the request for hearing; and
(iii) Listing the witnesses who will be providing testimony at the hearing.
(3) The notice of hearing will require CMS or a contractor that wishes to attend the hearing as a participant to reply to the notice by:
(i) Acknowledging whether it plans to attend the hearing at the time and place proposed in the notice of hearing; and
(ii) Specifying who from the entity plans to attend the hearing.
(d)
(e) * * *
(3) The request must be in writing, except that a party may orally request that a hearing be rescheduled in an emergency circumstance the day prior to or day of the hearing. The ALJ must document all oral requests for a rescheduled hearing in writing and maintain the documentation in the administrative record.
(4) The ALJ may change the time or place of the hearing if the party has good cause.
(g) * * *
(3) * * *
(vii) The party or representative has a prior commitment that cannot be changed without significant expense.
(viii) The party or representative asserts that he or she did not receive the notice of hearing and is unable to appear at the scheduled time and place.
(h)
(i)
(2) The party must state the reason for the objection and state the time and/or place he or she wants an in-person or VTC hearing to be held.
(4) When a party's request for an in-person or VTC hearing as specified under paragraph (i)(1) of this section is granted and an adjudication time frame applies in accordance with § 405.1016, the ALJ issues a decision, dismissal, or remand to the QIC within the adjudication time frame specified in § 405.1016 (including any applicable extensions provided in this subpart) unless the party requesting the hearing
(5) The ALJ may grant the request, with the concurrence of the Chief ALJ or designee, upon a finding of good cause and will reschedule the hearing for a time and place when the party may appear in person or by VTC before the ALJ.
(j)
(a)
(b)
(i) A statement that the issues before the ALJ include all of the issues brought out in the initial determination, redetermination, or reconsideration that were not decided entirely in a party's favor, for the claims specified in the request for hearing; and
(ii) A statement of any specific new issues the ALJ will consider in accordance with § 405.1032.
(2) The notice will inform the parties that they may designate a person to represent them during the proceedings.
(3) The notice must include an explanation of the procedures for requesting a change in the time or place of the hearing, a reminder that the ALJ may dismiss the hearing request if the appellant fails to appear at the scheduled hearing without good cause, and other information about the scheduling and conduct of the hearing.
(4) The appellant will also be told if his or her appearance or that of any other party or witness is scheduled by VTC, telephone, or in person. If the ALJ has scheduled the appellant or other party to appear at the hearing by VTC, the notice of hearing will advise that the scheduled place for the hearing is a VTC site and explain what it means to appear at the hearing by VTC.
(5) The notice advises the appellant or other parties that if they object to appearing by VTC or telephone, and wish instead to have their hearing at a time and place where they may appear in person before the ALJ, they must follow the procedures set forth at § 405.1020(i) for notifying the ALJ of their objections and for requesting an in-person hearing.
(c)
(2) If the party states that he or she did not receive the notice of hearing, a copy of the notice is sent to him or her by certified mail or other means requested by the party and in accordance with OMHA procedures.
(3) The party may request that the ALJ reschedule the hearing in accordance with § 405.1020(e).
(b) The party must state the reasons for his or her objections and send a copy of the objections to all other parties who were sent a copy of the notice of hearing, and CMS or a contractor that elected to be a party to the hearing.
(c) The ALJ makes a decision on the objections either in writing, at a prehearing conference, or at the hearing.
(a) An ALJ or attorney adjudicator cannot adjudicate an appeal if he or she is prejudiced or partial to any party or has any interest in the matter pending for decision.
(b) If a party objects to the ALJ or attorney adjudicator assigned to adjudicate the appeal, the party must notify the ALJ within 10 calendar days of the date of the notice of hearing if a hearing is scheduled, or the ALJ or attorney adjudicator at any time before a decision, dismissal order, or remand order is issued if no hearing is scheduled. The ALJ or attorney adjudicator considers the party's objections and decides whether to proceed with the appeal or withdraw.
(c) If the ALJ or attorney adjudicator withdraws, another ALJ or attorney adjudicator will be assigned to adjudicate the appeal. If the ALJ or attorney adjudicator does not withdraw, the party may, after the ALJ or attorney adjudicator has issued an action in the case, present his or her objections to the Council in accordance with § 405.1100 through § 405.1130. The Council will then consider whether the decision or dismissal should be revised or if applicable, a new hearing held before another ALJ. If the case is escalated to the Council after a hearing is held but before the ALJ issues a decision, the Council considers the reasons the party objected to the ALJ during its review of the case and, if the Council deems it necessary, may remand the case to another ALJ for a hearing and decision.
(d) If the party objects to the ALJ or attorney adjudicator and the ALJ or attorney adjudicator subsequently withdraws from the appeal, any adjudication time frame that applies to the appeal in accordance with § 405.1016 is extended by 14 calendar days.
(a)
(2)
(i) The new evidence is, in the opinion of the ALJ or attorney adjudicator, material to an issue addressed in the QIC's reconsideration and that issue was not identified as a material issue prior to the QIC's reconsideration;
(ii) The new evidence is, in the opinion of the ALJ, material to a new issue identified in accordance with § 405.1032(b)(1);
(iii) The party was unable to obtain the evidence before the QIC issued its reconsideration and submits evidence that, in the opinion of the ALJ or attorney adjudicator, demonstrates the party made reasonable attempts to
(iv) The party asserts that the evidence was submitted to the QIC or another contractor and submits evidence that, in the opinion of the ALJ or attorney adjudicator, demonstrates the new evidence was submitted to the QIC or another contractor before the QIC issued the reconsideration; or
(v) In circumstances not addressed in paragraphs (a)(2)(i) through (iv) of this section, the ALJ or attorney adjudicator determines that the party has demonstrated that it could not have obtained the evidence before the QIC issued its reconsideration.
(3)
(4)
(b)
(a)
(b)
(2) The ALJ may limit testimony and/or argument at the hearing that are not relevant to an issue before the ALJ, that are repetitive of evidence or testimony already in the record, or that relate to an issue that has been sufficiently developed or on which the ALJ has already ruled. The ALJ may, but is not required to, provide the party or representative with an opportunity to submit additional written statements and affidavits on the matter, in lieu of testimony and/or argument at the hearing. The written statements and affidavits must be submitted within the time frame designated by the ALJ.
(3) If the ALJ determines that a party or party's representative is uncooperative, disruptive to the hearing, or abusive during the course of the hearing after the ALJ has warned the party or representative to stop such behavior, the ALJ may excuse the party or representative from the hearing and continue with the hearing to provide the other parties and participants with an opportunity to offer testimony and/or argument. If a party or representative was excused from the hearing, the ALJ will provide the party or representative with an opportunity to submit written statements and affidavits in lieu of testimony and/or argument at the hearing, and the party or representative may request a recording of the hearing in accordance with § 405.1042 and respond in writing to any statements made by other parties or participants and/or testimony of the witnesses at the hearing. The written statements and affidavits must be submitted within the time frame designated by the ALJ.
(c)
(d)
(e)
(2) If the appellant requests the continuance and an adjudication period applies to the appeal in accordance with § 405.1016, the adjudication period is extended by the period between the initial hearing date and the continued hearing date.
(f)
(2) If the appellant requests the supplemental hearing and an adjudication period applies to the appeal in accordance with § 405.1016, the adjudication period is extended by the period between the initial hearing date and the supplemental hearing date.
(a)
(b)
(i) There is new and material evidence that was not available or known at the time of the determination and that may result in a different conclusion; or
(ii) The evidence that was considered in making the determination clearly shows on its face that an obvious error was made at the time of the determination.
(2)
(3)
(c)
(2) Before a claim may be added to a pending appeal, the appellant must submit evidence that demonstrates the information that constitutes a complete request for hearing in accordance with § 405.1014(b) and other materials related to the claim that the appellant seeks to add to the pending appeal were sent to the other parties to the claim in accordance with § 405.1014(d).
(d)
(2)
(a) If an ALJ or attorney adjudicator believes that the written record is missing information that is essential to resolving the issues on appeal and that information can be provided only by CMS or its contractors, the information may be requested from the QIC that conducted the reconsideration or its successor.
(1) Official copies of redeterminations and reconsiderations that were conducted on the appealed claims can be provided only by CMS or its contractors. Prior to issuing a request for information to the QIC, OMHA will confirm whether an electronic copy of the redetermination or reconsideration is available in the official system of record, and if so will accept the electronic copy as an official copy.
(2) “Can be provided only by CMS or its contractors” means the information is not publicly available, is not in the possession of, and cannot be requested and obtained by one of the parties. Information that is publicly available is information that is available to the general public via the Internet or in a printed publication. Information that is publicly available includes, but is not limited to, information available on a CMS or contractor Web site or information in an official CMS or DHHS publication (including, but not limited to, provisions of NCDs or LCDs, procedure code or modifier descriptions, fee schedule data, and contractor operating manual instructions).
(b) The ALJ or attorney adjudicator retains jurisdiction of the case, and the case remains pending at OMHA.
(c) The QIC has 15 calendar days after receiving the request for information to furnish the information or otherwise respond to the information request directly or through CMS or another contractor.
(d) If an adjudication period applies to the appeal in accordance with § 405.1016, the adjudication period is extended by the period between the date of the request for information and the date the QIC responds to the request or 20 calendar days after the date of the request, whichever occurs first.
The revisions read as follows:
(a) * * *
(1) Discovery is permissible only when CMS or its contractor elects to be a party to an ALJ hearing, in accordance with § 405.1012.
(f)
(a)
(b)
(i) All the parties who would be sent a notice of hearing in accordance with § 405.1020(c) indicate in writing that they do not wish to appear before an ALJ at a hearing, including a hearing conducted by telephone or video-teleconferencing, if available; or
(ii) The appellant lives outside the United States and does not inform OMHA that he or she wants to appear at a hearing before an ALJ, and there are no other parties who would be sent a notice of hearing in accordance with § 405.1020(c) and who wish to appear.
(2) When a hearing is not held, the decision of the ALJ or attorney adjudicator must refer to the evidence in the record on which the decision was based.
(c)
(a) The ALJ may decide on his or her own, or at the request of any party to the hearing, to hold a prehearing or posthearing conference to facilitate the hearing or the hearing decision.
(b) The ALJ informs the parties who will be or were sent a notice of hearing in accordance with § 405.1020(c), and CMS or a contractor that has elected to be a participant in the proceedings or party to the hearing at the time the notice of conference is sent, of the time, place, and purpose of the conference at least 7 calendar days before the conference date, unless a party indicates in writing that it does not wish to receive a written notice of the conference.
(c) At the conference—
(1) The ALJ or an OMHA attorney designated by the ALJ conducts the conference, but only the ALJ conducting a conference may consider matters in addition to those stated in the conference notice if the parties consent to consideration of the additional matters in writing.
(2) An audio recording of the conference is made.
(d) The ALJ issues an order to all parties and participants who attended the conference stating all agreements and actions resulting from the conference. If a party does not object within 10 calendar days of receiving the order, or any additional time granted by the ALJ, the agreements and actions become part of the administrative record and are binding on all parties.
(a)
(2) The record will include marked as exhibits, the appealed determinations, and documents and other evidence used in making the appealed determinations and the ALJ's or attorney adjudicator's decision, including, but not limited to, claims, medical records, written statements, certificates, reports, affidavits, and any other evidence the ALJ or attorney adjudicator admits. The record will also include any evidence excluded or not considered by the ALJ or attorney adjudicator, including, but not limited to, new evidence submitted by a provider or supplier, or beneficiary represented by a provider or supplier, for which no good cause was established, and duplicative evidence submitted by a party.
(3) A party may request and review a copy of the record prior to or at the hearing, or, if a hearing is not held, at any time before the notice of decision is issued.
(4) If a request for review is filed or the case is escalated to the Council, the complete record, including any prehearing and posthearing conference and hearing recordings, is forwarded to the Council.
(5) A typed transcription of the hearing is prepared if a party seeks judicial review of the case in a Federal district court within the stated time period and all other jurisdictional criteria are met, unless, upon the Secretary's motion prior to the filing of an answer, the court remands the case.
(b)
(2) If a party requests a copy of all or part of the record from OMHA or the ALJ or attorney adjudicator and an opportunity to comment on the record, any adjudication period that applies in accordance with § 405.1016 is extended by the time beginning with the receipt of the request through the expiration of the time granted for the party's response.
(3) If a party requests a copy of all or part of the record and the record, including any audio recordings, contains information pertaining to an individual that the requesting party is not entitled to receive, such as personally identifiable information or protected health information, such portions of the record will not be furnished unless the requesting party obtains consent from the individual.
(a)
(2) It is within the discretion of the ALJ to grant or deny an appellant's request for consolidation. In considering an appellant's request, the ALJ may consider factors such as whether the claims at issue may be more efficiently decided if the appeals are consolidated for hearing. In considering the appellant's request for consolidation, the ALJ must take into account any adjudication deadlines for each appeal and may require an appellant to waive the adjudication deadline associated with one or more appeals if consolidation otherwise prevents the ALJ from deciding all of the appeals at issue within their respective deadlines.
(3) The ALJ may also propose on his or her own motion to consolidate two or more appeals in one hearing for administrative efficiency, but may not require an appellant to waive the adjudication deadline for any of the consolidated cases.
(4) Notice of a consolidated hearing must be included in the notice of hearing issued in accordance with §§ 405.1020 and 405.1022.
(b)
(i) A consolidated decision and record; or
(ii) A separate decision and record on each appeal.
(2) If a separate decision and record on each appeal is made, the ALJ is responsible for making sure that any evidence that is common to all appeals and material to the common issue to be decided, and audio recordings of any conferences that were conducted and the consolidated hearing are included in each individual administrative record, as applicable.
(3) If a hearing will not be conducted for multiple appeals that are before the same ALJ or attorney adjudicator, and the appeals involve one or more of the same issues, the ALJ or attorney adjudicator may make a consolidated decision and record at the request of the appellant or on the ALJ's or attorney adjudicator's own motion.
(c)
(a)
(2)
(i) The specific reasons for the determination, including, to the extent appropriate, a summary of any clinical or scientific evidence used in making the determination;
(ii) For any new evidence that was submitted for the first time at the OMHA level and subject to a good cause determination pursuant to § 405.1028, a discussion of the new evidence and the good cause determination that was made.
(iii) The procedures for obtaining additional information concerning the decision; and
(iv) Notification of the right to appeal the decision to the Council, including instructions on how to initiate an appeal under this section.
(3)
(b)
(2)
(i) The specific reasons for the determination, including a summary of the evidence considered and applicable authorities;
(ii) The procedures for obtaining additional information concerning the decision; and
(iii) Notification that the decision is binding and is not subject to further review, unless reopened and revised by the ALJ or attorney adjudicator.
(c)
(a) The decision of the ALJ or attorney adjudicator on a request for hearing is binding on all parties unless—
(1) A party requests a review of the decision by the Council within the stated time period or the Council reviews the decision issued by an ALJ or attorney adjudicator under the procedures set forth in § 405.1110, and the Council issues a final decision or remand order or the appeal is escalated to Federal district court under the provisions at § 405.1132 and the Federal district court issues a decision.
(2) The decision is reopened and revised by an ALJ or attorney adjudicator or the Council under the procedures explained in § 405.980;
(3) The expedited access to judicial review process at § 405.990 is used;
(4) The ALJ's or attorney adjudicator's decision is a recommended decision directed to the Council and the Council issues a decision; or
(5) In a case remanded by a Federal district court, the Council assumes jurisdiction under the procedures in § 405.1138 and the Council issues a decision.
(b) The decision of the ALJ or attorney adjudicator on a request for review of a QIC dismissal is binding on all parties unless the decision is reopened and revised by the ALJ or attorney adjudicator under the procedures in § 405.980.
(a)
(1) Neither the party that requested the hearing nor the party's representative appears at the time and place set for the hearing, if—
(i) The party was notified before the time set for the hearing that the request for hearing might be dismissed for failure to appear, the record contains documentation that the party acknowledged the notice of hearing, and the party does not contact the ALJ within 10 calendar days after the hearing, or does contact the ALJ but the ALJ determines the party did not demonstrate good cause for not appearing; or
(ii) The record does not contain documentation that the party acknowledged the notice of hearing, the ALJ sends a notice to the party at the last known address asking why the party did not appear, and the party does not respond to the ALJ's notice within 10 calendar days after receiving the notice or does contact the ALJ but the ALJ determines the party did not demonstrate good cause for not appearing.
(iii) In determining whether good cause exists under paragraphs (a)(1)(i) and (ii) of this section, the ALJ considers any physical, mental, educational, or linguistic limitations (including any lack of facility with the English language), that the party may have.
(2) The person or entity requesting a hearing has no right to it under § 405.1002.
(3) The party did not request a hearing within the stated time period and the ALJ or attorney adjudicator has not found good cause for extending the deadline, as provided in § 405.1014(e).
(4) The beneficiary whose claim is being appealed died while the request for hearing is pending and all of the following criteria apply:
(i) The request for hearing was filed by the beneficiary or the beneficiary's representative, and the beneficiary's surviving spouse or estate has no remaining financial interest in the case. In deciding this issue, the ALJ or attorney adjudicator considers if the surviving spouse or estate remains liable for the services that were denied or a Medicare contractor held the beneficiary liable for subsequent similar services under the limitation of liability provisions based on the denial of the services at issue.
(ii) No other individuals or entities that have a financial interest in the case wish to pursue an appeal under § 405.1002.
(iii) No other individual or entity filed a valid and timely request for an ALJ hearing in accordance to § 405.1014.
(5) The ALJ or attorney adjudicator dismisses a hearing request entirely or refuses to consider any one or more of the issues because a QIC, an ALJ or attorney adjudicator, or the Council has made a previous determination or decision under this subpart about the appellant's rights on the same facts and on the same issue(s) or claim(s), and this previous determination or decision has become binding by either administrative or judicial action.
(6) The appellant abandons the request for hearing. An ALJ or attorney adjudicator may conclude that an appellant has abandoned a request for hearing when OMHA attempts to schedule a hearing and is unable to contact the appellant after making reasonable efforts to do so.
(7) The appellant's request is not complete in accordance with § 405.1014(a)(1) or the appellant, other than an unrepresented beneficiary, did not send a copy of its request to the other parties in accordance with § 405.1014(d), after the appellant is provided with an opportunity to complete the request and/or send a copy of the request to the other parties.
(b)
(1) The person or entity requesting a review of a dismissal has no right to it under § 405.1004.
(2) The party did not request a review within the stated time period and the ALJ or attorney adjudicator has not found good cause for extending the deadline, as provided in § 405.1014(e).
(3) The beneficiary whose claim is being appealed died while the request for review is pending and all of the following criteria apply:
(i) The request for review was filed by the beneficiary or the beneficiary's representative, and the beneficiary's surviving spouse or estate has no remaining financial interest in the case. In deciding this issue, the ALJ or attorney adjudicator considers if the surviving spouse or estate remains liable for the services that were denied or a Medicare contractor held the beneficiary liable for subsequent similar services under the limitation of liability provisions based on the denial of the services at issue.
(ii) No other individuals or entities that have a financial interest in the case wish to pursue an appeal under § 405.1004.
(iii) No other individual or entity filed a valid and timely request for a review of the QIC dismissal in accordance to § 405.1014.
(4) The appellant's request is not complete in accordance with § 405.1014(a)(1) or the appellant, other than an unrepresented beneficiary, did not send a copy of its request to the other parties in accordance with § 405.1014(d), after the appellant is provided with an opportunity to complete the request and/or send a copy of the request to the other parties.
(c)
(d)
(e)
(a) The dismissal of a request for a hearing is binding, unless it is vacated by the Council under § 405.1108(b), or vacated by the ALJ or attorney adjudicator under § 405.1052(e).
(b) The dismissal of a request for review of a QIC dismissal of a request for reconsideration is binding and not subject to further review unless it is vacated by the ALJ or attorney adjudicator under § 405.1052(e).
(a)
(2) If the QIC does not furnish the case file for an appealed reconsideration, an ALJ or attorney adjudicator may issue a remand directing the QIC to reconstruct the record or, if it is not able to do so, initiate a new appeal adjudication.
(3) If the QIC or another contractor is able to reconstruct the record for a remanded case and returns the case to OMHA, the case is no longer remanded and the reconsideration is no longer vacated, and any adjudication period that applies to the appeal in accordance with § 405.1016 is extended by the period between the date of the remand and the date that case is returned to OMHA.
(b)
(c)
(2)
(d)
(e)
(2) Unless the appellant is entitled to relief pursuant to § 426.460(b)(1), § 426.488(b), or § 426.560(b)(1) of this chapter, the ALJ or attorney adjudicator applies the LCD or NCD in place on the date the item or service was provided.
(f)
(g)
A remand of a request for hearing or request for review is binding unless vacated by the Chief ALJ or a designee in accordance with § 405.1056(g).
(a) All laws and regulations pertaining to the Medicare and Medicaid programs, including, but not limited to Titles XI, XVIII, and XIX of the Social Security Act and applicable implementing regulations, are binding on ALJs and attorney adjudicators, and the Council.
(b) CMS Rulings are published under the authority of the Administrator, CMS. Consistent with § 401.108 of this chapter, rulings are binding on all CMS components, on all HHS components that adjudicate matters under the jurisdiction of CMS, and on the Social Security Administration to the extent that components of the Social Security Administration adjudicate matters under the jurisdiction of CMS.
(c) Precedential decisions designated by the Chair of the Departmental Appeals Board in accordance with § 401.109 of this chapter, are binding on all CMS components, all HHS components that adjudicate matters under the jurisdiction of CMS, and on the Social Security Administration to the extent that components of the Social
(a) The appellant or any other party to an ALJ's or attorney adjudicator's decision or dismissal may request that the Council review the ALJ's or attorney adjudicator's decision or dismissal.
(b) Under circumstances set forth in §§ 405.1016 and 405.1108, the appellant may request that a case be escalated to the Council for a decision even if the ALJ or attorney adjudicator has not issued a decision, dismissal, or remand in his or her case.
(c) When the Council reviews an ALJ's or attorney adjudicator's decision, it undertakes a
(d) When deciding an appeal that was escalated from the OMHA level to the Council, the Council will issue a final decision or dismissal order or remand the case to the OMHA Chief ALJ within 180 calendar days of receipt of the appellant's request for escalation, unless the 180 calendar day period is extended as provided in this subpart.
(a)(1) A party to a decision or dismissal issued by an ALJ or attorney adjudicator may request a Council review if the party files a written request for a Council review within 60 calendar days after receipt of the ALJ's or attorney adjudicator's decision or dismissal.
(2) For purposes of this section, the date of receipt of the ALJ's or attorney adjudicator's decision or dismissal is presumed to be 5 calendar days after the date of the notice of the decision or dismissal, unless there is evidence to the contrary.
(3) The request is considered as filed on the date it is received by the entity specified in the notice of the ALJ's or attorney adjudicator's action.
(b) A party requesting a review may ask that the time for filing a request for Council review be extended if—
(1) The request for an extension of time is in writing;
(2) It is filed with the Council; and
(3) It explains why the request for review was not filed within the stated time period. If the Council finds that there is good cause for missing the deadline, the time period will be extended. To determine whether good cause exists, the Council uses the standards outlined at § 405.942(b)(2) and (3).
(c) A party does not have the right to seek Council review of an ALJ's or attorney adjudicator's remand to a QIC, affirmation of a QIC's dismissal of a request for reconsideration, or dismissal of a request for review of a QIC dismissal.
(d) For purposes of requesting Council review (§§ 405.1100 through 405.1140), unless specifically excepted, the term “party”, includes CMS where CMS has entered into a case as a party according to § 405.1012. The term, “appellant,” does not include CMS, where CMS has entered into a case as a party according to § 405.1012.
(a) When a request for a Council review is filed after an ALJ or attorney adjudicator has issued a decision or dismissal, the request for review must be filed with the entity specified in the notice of the ALJ's or attorney adjudicator's action. The appellant must also send a copy of the request for review to the other parties to the ALJ or attorney adjudicator decision or dismissal who received notice of the decision or dismissal. Failure to copy the other parties tolls the Council's adjudication deadline set forth in § 405.1100 until all parties to the ALJ or attorney adjudicator decision or dismissal receive notice of the request for Council review. If the request for review is timely filed with an entity other than the entity specified in the notice of the ALJ's or attorney adjudicator's action, the Council's adjudication period to conduct a review begins on the date the request for review is received by the entity specified in the notice of the ALJ's or attorney adjudicator's action. Upon receipt of a request for review from an entity other than the entity specified in the notice of the ALJ's or attorney adjudicator's action, the Council sends written notice to the appellant of the date of receipt of the request and commencement of the adjudication timeframe.
(b) If an appellant files a request to escalate an appeal to the Council level because the ALJ or attorney adjudicator has not completed his or her action on the request for hearing within an applicable adjudication period under § 405.1016, the request for escalation must be filed with OMHA and the appellant must also send a copy of the request for escalation to the other parties who were sent a copy of the QIC reconsideration. Failure to copy the other parties tolls the Council's adjudication deadline set forth in § 405.1100 until all parties who were sent a copy of the QIC reconsideration receive notice of the request for escalation. In a case that has been escalated from OMHA, the Council's 180 calendar day period to issue a final decision, dismissal order, or remand order begins on the date the request for escalation is received by the Council.
(a)
(b)
(i) CMS or its contractor participated in the appeal at the OMHA level; and
(ii) In CMS' view, the ALJ's or attorney adjudicator's decision or dismissal is not supported by the preponderance of evidence in the record or the ALJ or attorney adjudicator abused his or her discretion.
(2) CMS' referral to the Council is made in writing and must be filed with the Council no later than 60 calendar days after the ALJ's or attorney adjudicator's decision or dismissal is issued. The written referral will state the reasons why CMS believes the Council must review the case on its own motion. CMS will send a copy of its referral to all parties to the ALJ's or attorney adjudicator's action who received a copy of the decision under § 405.1046(a) or the notice of dismissal under § 405.1052(d), and to the OMHA Chief ALJ. Parties to the ALJ's or attorney adjudicator's action may file exceptions to the referral by submitting written comments to the Council within 20 calendar days of the referral notice. A party submitting comments to the Council must send such comments to CMS and all other parties to the ALJ's or attorney adjudicator's action who received a copy of the decision under § 405.1046(a) or the notice of dismissal under § 405.1052(d).
(c)
(2)
(d)
(a) The request for Council review must be filed with the entity specified in the notice of the ALJ's or attorney adjudicator's action. The request for review must be in writing and may be made on a standard form. A written request that is not made on a standard form is accepted if it contains the beneficiary's name; Medicare health insurance claim number; the specific service(s) or item(s) for which the review is requested; the specific date(s) of service; the date of the ALJ's or attorney adjudicator's decision or dismissal order, if any; and the name and signature of the party or the representative of the party; and any other information CMS may decide.
(b) The request for review must identify the parts of the ALJ's or attorney adjudicator's action with which the party requesting review disagrees and explain why he or she disagrees with the ALJ's or attorney adjudicator's decision, dismissal, or other determination being appealed. For example, if the party requesting review believes that the ALJ's or attorney adjudicator's action is inconsistent with a statute, regulation, CMS Ruling, or other authority, the request for review should explain why the appellant believes the action is inconsistent with that authority.
(c) The Council will limit its review of an ALJ's or attorney adjudicator's actions to those exceptions raised by the party in the request for review, unless the appellant is an unrepresented beneficiary. For purposes of this section only, we define a representative as anyone who has accepted an appointment as the beneficiary's representative, except a member of the beneficiary's family, a legal guardian, or an individual who routinely acts on behalf of the beneficiary, such as a family member or friend who has a power of attorney.
(c) * * *
(4) * * *
(iii) Information about the beneficiary's right to appeal the QIC's reconsideration decision to OMHA for an ALJ hearing in accordance with subpart I of this part, including how to request an appeal and the time period for doing so.
(5) Unless the beneficiary requests an extension in accordance with paragraph (c)(6) of this section, if the QIC does not issue a decision within 72 hours of receipt of the request, the QIC must notify the beneficiary of his or her right to have the case escalated to OMHA for an ALJ hearing in accordance with subpart I of this part, if the amount remaining in controversy after the QIO determination meets the requirements for an ALJ hearing under § 405.1006.
Secs. 1102 and 1871 of the Social Security Act (42 U.S.C. 1302 and 1395hh).
(c) * * *
(1) If an enrollee receives immediate QIO review (as provided in § 422.622) of a determination of noncoverage of inpatient hospital care the enrollee is not entitled to review of that issue by the MA organization.
(d)
(2) The following regulations in part 405 of this chapter, and any references thereto, specifically do not apply under this subpart:
(i) Section 405.950 (time frames for making a redetermination).
(ii) Section 405.970 (time frames for making a reconsideration following a contractor redetermination, including the option to escalate an appeal to the OMHA level).
(iii) Section 405.1016 (time frames for deciding an appeal of a QIC reconsideration, or escalated request for a QIC reconsideration, including the option to escalate an appeal to the Council).
(iv) The option to request that an appeal be escalated from the OMHA level to the Council as provided in § 405.1100(b), and time frames for the Council to decide an appeal of an ALJ's or attorney adjudicator's decision or an appeal that is escalated from the OMHA level to the Council as provided in § 405.1100(c) and (d).
(v) Section 405.1132 (request for escalation to Federal court).
(vi) Sections 405.956(b)(8), 405.966(a)(2), 405.976(b)(5)(ii), 405.1018(c), 405.1028(a), and 405.1122(c), and any other reference to requiring a determination of good cause for the introduction of new evidence by a provider, supplier, or a beneficiary represented by a provider or supplier.
(b) * * *
(2) If the reconsidered determination is adverse (that is, does not completely reverse the MA organization's adverse organization determination), inform the parties of their right to an ALJ hearing if the amount in controversy meets the requirements of § 422.600;
(b)
(2) For purposes of this section, the date of receipt of the reconsideration is presumed to be 5 calendar days after the date of the notice of the reconsidered determination, unless there is evidence to the contrary.
Any party to the ALJ's or attorney adjudicator's decision or dismissal, including the MA organization, who is dissatisfied with the decision or dismissal, may request that the Council review the decision or dismissal. The regulations under part 405 of this chapter regarding Council review apply to matters addressed by this subpart to the extent that they are appropriate, except as provided in § 422.562(d)(2).
Sections 1102, 1106, 1860D-1 through 1860D-42, and 1871 of the Social Security Act (42 U.S.C. 1302, 1306, 1395w-101 through 1395w-152, and 1395hh).
(b) The requirements regarding reopenings, ALJ hearings and ALJ and attorney adjudicator decisions, Council review, and judicial review are set forth in subpart U of this chapter.
(b) * * *
(4) * * *
(v) If the ALJ or attorney adjudicator affirms the IRE's adverse coverage determination, in whole or in part, the right to request Council review of the ALJ's or attorney adjudicator's decision, as specified in § 423.1974.
(vi) If the Council affirms the ALJ's or attorney adjudicator's adverse coverage determination, in whole or in part, the right to judicial review of the decision if the amount in controversy meets the requirements in § 423.1976.
This subpart sets forth the requirements relating to the following:
(a) Part D sponsors, the Part D IRE, ALJs and attorney adjudicators, and the Council with respect to reopenings.
(b) ALJs with respect to hearings and decisions or decisions of attorney adjudicators if no hearing is conducted.
(c) The Council with respect to review of Part D appeals.
(d) Part D enrollees' rights with respect to reopenings, ALJ hearings and ALJ or attorney adjudicator reviews, Council reviews, and judicial review by a Federal District Court.
(c) * * *
(1) * * *
(ii) The enrollee requests aggregation at the same time the requests for hearing are filed, and the request for aggregation and requests for hearing are filed within 60 calendar days after receipt of the notice of reconsideration for each of the reconsiderations being appealed, unless the deadline to file one or more of the requests for hearing has been extended in accordance with § 423.2014(d); and
(iii) The appeals the enrollee seeks to aggregate involve the delivery of prescription drugs to a single enrollee, as determined by an ALJ or attorney adjudicator. Only an ALJ may determine the appeals the enrollee seeks to aggregate do not involve the delivery of prescription drugs to a single enrollee.
(2) * * *
(ii) The enrollees request aggregation at the same time the requests for hearing are filed, and the request for aggregation and requests for hearing are filed within 60 calendar days after receipt of the notice of reconsideration for each of the reconsiderations being appealed, unless the deadline to file one or more of the requests for hearing has been extended in accordance with § 423.2014(d); and
(iii) The appeals the enrollees seek to aggregate involve the same prescription drugs, as determined by an ALJ or attorney adjudicator. Only an ALJ may determine the appeals the enrollees seek to aggregate do not involve the same prescription drugs.
(a)
(b)
(2) For purposes of this section, the date of receipt of the reconsideration determination is presumed to be 5 calendar days after the date of the written reconsideration determination, unless there is evidence to the contrary.
(c) * * *
(1) If a request for a hearing clearly shows that the amount in controversy is less than that required under § 423.1970, the ALJ or attorney adjudicator dismisses the request.
An enrollee who is dissatisfied with an ALJ's or attorney adjudicator's decision or dismissal may request that the Council review the ALJ's or attorney adjudicator's decision or dismissal as provided in § 423.2102.
(a) * * *
(1) * * *
(iii) An ALJ or attorney adjudicator to revise his or her decision; or
(iv) The Council to revise the ALJ or attorney adjudicator decision, or its review decision.
(2) When an enrollee has filed a valid request for an appeal of a coverage determination, redetermination, reconsideration, ALJ or attorney adjudicator decision, or Council review, no adjudicator has jurisdiction to reopen an issue that is under appeal until all appeal rights for that issue are exhausted. Once the appeal rights for the issue have been exhausted, the Part D plan sponsor, IRE, ALJ or attorney adjudicator, or Council may reopen as set forth in this section.
(4) Consistent with § 423.1978(d), the Part D plan sponsor's, IRE's, ALJ's or attorney adjudicator's, or Council's decision on whether to reopen is binding and not subject to appeal.
(d)
(2) An ALJ or attorney adjudicator may reopen his or her decision, or the Council may reopen an ALJ or attorney adjudicator decision on its own motion within 180 calendar days from the date of the decision for good cause in accordance with § 423.1986. If the decision was procured by fraud or similar fault, then the ALJ or attorney adjudicator may reopen his or her decision, or the Council may reopen an ALJ or attorney adjudicator decision at any time.
(3) The Council may reopen its review decision on its own motion within 180 calendar days from the date of the review decision for good cause in accordance with § 423.1986. If the Council's decision was procured by fraud or similar fault, then the Council may reopen at any time.
(e)
(2) An enrollee who received an ALJ's or attorney adjudicator's decision or a Part D plan sponsor may request that an ALJ or attorney adjudicator reopen his or her decision, or the Council reopen an ALJ or attorney adjudicator decision, within 180 calendar days from the date of the decision for good cause in accordance with § 423.1986.
(3) An enrollee who received a Council decision or a Part D plan sponsor may request that the Council reopen its decision within 180 calendar days from the date of the review decision for good cause in accordance with § 423.1986.
(d)
(e)
The revisions read as follows:
(d) * * *
(1)
(i) If a request for ALJ hearing or Council review is not pending, file a written EAJR request with the HHS Departmental Appeals Board, with his or her request for an ALJ hearing or Council review; or
(ii) If an appeal is already pending for an ALJ hearing or otherwise before OMHA or the Council, file a written EAJR request with the HHS Departmental Appeals Board.
(h)
(2) Whenever a review entity forwards a rejected EAJR request to OMHA or the Council, the appeal is considered timely filed and, if an adjudication time frame applies to the appeal, the adjudication time frame begins on the day the request is received by OMHA or the Council from the review entity.
(a) If an enrollee is dissatisfied with an IRE's reconsideration, the enrollee may request a hearing before an ALJ.
(b) A hearing before an ALJ may be conducted in-person, by video-teleconference, or by telephone. At the hearing, the enrollee may submit evidence subject to the restrictions in § 423.2018, examine the evidence used in making the determination under review, and present and/or question witnesses.
(c) In some circumstances, the Part D plan sponsor, CMS, or the IRE may participate in the proceedings on a request for an ALJ hearing as specified in § 423.2010.
(d) The ALJ or attorney adjudicator conducts a de novo review and issues a decision based on the administrative record, including, for an ALJ, any hearing record.
(e) If an enrollee waives his or her right to appear at the hearing in person or by telephone or video-teleconference, the ALJ or an attorney adjudicator may make a decision based on the evidence that is in the file and any new evidence that is submitted for consideration.
(g) An ALJ or attorney adjudicator may also issue a decision on the record on his or her own initiative if the evidence in the administrative record supports a fully favorable finding.
(a) An enrollee has a right to have an IRE's dismissal of a request for reconsideration reviewed by an ALJ or attorney adjudicator if—
(1) The enrollee files a written request for review within 60 calendar days after receipt of the notice of the IRE's dismissal.
(4) For purposes of meeting the 60 calendar day filing deadline, the request is considered as filed on the date it is received by the office specified in the IRE's dismissal.
(b) If the ALJ or attorney adjudicator determines that the IRE's dismissal was in error, he or she vacates the dismissal and remands the case to the IRE for a reconsideration in accordance with § 423.2056.
(c) If the ALJ or attorney adjudicator affirms the IRE's dismissal of a reconsideration request, he or she issues a notice of decision affirming the IRE's dismissal in accordance with § 423.2046(b).
(d) The ALJ or attorney adjudicator may dismiss the request for review of an IRE's dismissal in accordance with § 423.2052(b).
The enrollee (or the enrollee's representative) who filed the request for hearing is the only party to the proceedings on a request for an ALJ hearing.
(a)
(2) An ALJ may request, but may not require, CMS, the IRE, and/or the Part D plan sponsor to participate in any proceedings before the ALJ, including the oral hearing, if any. The ALJ cannot draw any adverse inferences if CMS, the IRE, and/or the Part D plan sponsor decide not to participate in any proceedings before an ALJ, including the hearing.
(b)
(2)
(3)
(i) If a standard request for hearing was filed, if no hearing is scheduled, within 30 calendar days after notification that a standard request for hearing was filed;
(ii) If an expedited hearing is requested, but no hearing has been scheduled, within 2 calendar days after notification that a request for an expedited hearing was filed.
(iii) If a non-expedited hearing is scheduled, within 5 calendar days after receiving the notice of hearing; or
(iv) If an expedited hearing is scheduled, within 1 calendar day after receiving the notice of hearing. Requests may be made orally or submitted by facsimile to the hearing office.
(c)
(1) If no hearing is scheduled, at least 20 calendar days before the ALJ or attorney adjudicator issues a decision, dismissal, or remand;
(2) If a non-expedited hearing is scheduled, within 5 calendar days of receipt of a request to participate; or
(3) If an expedited hearing is scheduled, within 1 calendar of receipt of a request to participate.
(d)
(2) When CMS, the IRE, and/or the Part D plan sponsor participates in an ALJ hearing, CMS, the IRE, and/or the Part D plan sponsor may not be called as a witness during the hearing and is not subject to examination or cross-examination by the enrollee, but the enrollee may provide testimony to rebut factual or policy statements made by a participant and the ALJ may question the participant about its testimony.
(3) CMS, IRE, and/or Part D plan sponsor positon papers and written testimony are subject to the following:
(i) Unless the ALJ or attorney adjudicator grants additional time to submit a position paper or written testimony, a position paper and written testimony must be submitted—
(A) Within 14 calendar days for a standard appeal, or 1 calendar day for an expedited appeal, after receipt of the ALJ's or attorney adjudicator's decision on a request to participate if no hearing has been scheduled; or
(B) No later than 5 calendar days prior to the hearing if a non-expedited hearing is scheduled, or 1 calendar day prior to the hearing if an expedited hearing is scheduled.
(ii) A copy of any position paper and written testimony that CMS, the IRE, or the Part D plan sponsor submits to OMHA must be sent within the same time frames specified in paragraph (d)(3)(i)(A) and (B) of this section to the enrollee.
(iii) If CMS, the IRE, and/or the Part D plan sponsor fails to send a copy of its position paper or written testimony to the enrollee or fails to submit its position paper or written testimony within the time frames described in this section, the position paper or written testimony will not be considered in deciding the appeal.
(e)
(2) If the request to participate is determined to be invalid, the written notice of an invalid request to participate must be sent to the entity that made the request to participate and the enrollee.
(i) If no hearing is scheduled or the request to participate was made after the hearing occurred, the written notice of an invalid request to participate must be sent no later than the date the notice of decision, dismissal, or remand is mailed.
(ii) If a non-expedited hearing is scheduled, the written notice of an invalid request to participate must be sent prior to the hearing. If the notice would be sent fewer than 5 calendar days before the hearing is scheduled to occur, oral notice must be provided to the entity that submitted the request, and the written notice must be sent as soon as possible after the oral notice is provided.
(iii) If an expedited hearing is scheduled, oral notice of an invalid request to participate must be provided to the entity that submitted the request, and the written notice must be sent as soon as possible after the oral notice is provided.
(a)
(i) The name, address, telephone number, and Medicare health insurance claim number of the enrollee.
(ii) The name, address, and telephone number of the appointed representative, as defined at § 423.560, if any.
(iii) The Medicare appeal number, if any, assigned to the IRE reconsideration or dismissal being appealed.
(iv) The prescription drug in dispute.
(v) The plan name.
(vi) The reasons the enrollee disagrees with the IRE's reconsideration or dismissal being appealed.
(2) The enrollee must submit a statement of any additional evidence to be submitted and the date it will be submitted.
(3) The enrollee must submit a statement that the enrollee is requesting an expedited hearing, if applicable.
(b)
(c)
(2) If supporting materials submitted with a request clearly provide information required for a complete request, the materials will be considered in determining whether the request is complete.
(d)
(1) Within 60 calendar days from the date the enrollee receives written notice of the IRE's reconsideration or dismissal being appealed.
(2) With the office specified in the IRE's reconsideration or dismissal.
(i) If the request for hearing is timely filed with an office other than the office specified in the IRE's reconsideration, the request is not treated as untimely, and any applicable time frame specified in § 423.2016 for deciding the appeal begins on the date the office specified in the IRE's reconsideration or dismissal receives the request for hearing.
(ii) If the request for hearing is filed with an office, other than the office specified in the IRE's reconsideration or dismissal, OMHA must notify the enrollee of the date the request was received in the correct office and the commencement of any applicable adjudication timeframe.
(e)
(2) Any request for an extension of time must be in writing or, for expedited reviews, in writing or oral. OMHA must document all oral requests in writing and maintain the documentation in the case file.
(3) The request must give the reasons why the request for a hearing or review was not filed within the stated time period, and must be filed with the request for hearing or review of an IRE dismissal with the office specified in the notice of reconsideration or dismissal.
(4) An ALJ or attorney adjudicator may find there is good cause for missing the deadline to file a request for an ALJ hearing or request for review of an IRE dismissal, or there is no good cause for missing the deadline to file a request for a review of an IRE dismissal, but only an ALJ may find there is no good cause for missing the deadline to file a request for an ALJ hearing. If good cause is found for missing the deadline, the time period for filing the request for hearing or request for review of an IRE dismissal will be extended. To determine whether good cause for late filing exists, the ALJ or attorney adjudicator uses the standards set forth in § 405.942(b)(2) and (3) of this chapter.
(5) If a request for hearing is not timely filed, any applicable adjudication period in § 423.2016 begins the date the ALJ or attorney adjudicator grants the request to extend the filing deadline.
(6) A determination granting a request to extend the filing deadline is not subject to further review.
(a)
(2) The adjudication period specified in paragraph (a)(1) of this section begins on the date that a timely filed request for hearing is received by the office specified in the IRE's reconsideration, or, if it is not timely filed, the date that the ALJ or attorney adjudicator grants any extension to the filing deadline.
(3) If the Council remands a case and the case was subject to an adjudication time frame under paragraph (a)(1) of this section, the remanded appeal will be subject to the same adjudication time frame beginning on the date that OMHA receives the Council remand.
(b)
(2)
(i) Make the decision to grant an expedited appeal within 5 calendar days of receipt of the request for an expedited hearing;
(ii) Give the enrollee prompt oral notice of this decision; and
(iii) Subsequently send to the enrollee at his or her last known address and to the Part D plan sponsor written notice of the decision. This notice may be provided within the written notice of hearing.
(3)
(i) Make this decision within 5 calendar days of receipt of the request for expedited hearing;
(ii) Give the enrollee prompt oral notice of the denial that informs the enrollee of the denial and explains that an ALJ or attorney adjudicator will process the enrollee's request using the 90 calendar day timeframe for non-expedited appeals; and
(iii) Subsequently send to the enrollee at his or her last known address and to the Part D plan sponsor an equivalent written notice of the decision within 3 calendar days after the oral notice.
(4)
(5)
(ii) The adjudication period specified in paragraph (b)(5)(i) of this section begins on the date that a timely provided request for hearing is received by the office specified in the IRE's reconsideration, or, if it is not timely provided, the date that an ALJ or attorney adjudicator grants any extension to the filing deadline.
(6)
(c)
(2) The adjudication periods specified in paragraphs (a)(1) and (b)(5) of this section are extended as otherwise specified in this subpart, and for the following events—
(i) The duration of a stay of action on adjudicating the matters at issue ordered by a court or tribunal of competent jurisdiction;
(ii) The duration of a stay of proceedings granted by an ALJ or attorney adjudicator on a motion by an enrollee.
(a)
(1) An ALJ or attorney adjudicator will not consider any evidence submitted regarding a change in condition of an enrollee after the appealed coverage determination was made.
(2) An ALJ or attorney adjudicator will remand a case to the Part D IRE where an enrollee wishes evidence on his or her change in condition after the coverage determination to be considered.
(b)
(2) If a represented enrollee submits written or other evidence later than 10 calendar days after receiving the notice of hearing, any applicable adjudication period specified in § 423.2016 is extended by the number of calendar days in the period between 10 calendar days after receipt of the notice of hearing and the day the evidence is received.
(3) The requirements of paragraph (b) of this section do not apply to unrepresented enrollees.
(c)
(2) If an enrollee submits written or other evidence later than 2 calendar days after receiving the notice of expedited hearing, any applicable adjudication period specified in § 423.2016 is extended by the number of calendar days in the period between 2 calendar days after receipt of the notice of expedited hearing and the day the evidence is received.
(d)
The revisions and additions read as follows:
(b)
(i) The ALJ may also offer to conduct a hearing by telephone if the request for hearing or administrative record suggests that a telephone hearing may be more convenient for the unrepresented enrollee.
(ii) The ALJ, with the concurrence of the Chief ALJ or designee, may find good cause that an in-person hearing should be conducted if—
(A) The video-teleconferencing or telephone technology is not available; or
(B) Special or extraordinary circumstances exist.
(2)
(i) The ALJ may find good cause for an appearance by video-teleconferencing if he or she determines that video-teleconferencing is necessary to examine the facts or issues involved in the appeal.
(ii) The ALJ, with the concurrence of the Chief ALJ or designee, may find good cause that an in-person hearing should be conducted if—
(A) The video-teleconferencing and telephone technology are not available; or
(B) Special or extraordinary circumstances exist.
(c)
(2) The notice of hearing will require the enrollee to reply to the notice by:
(i) Acknowledging whether they plan to attend the hearing at the time and place proposed in the notice of hearing, or whether they object to the proposed time and/or place of the hearing;
(ii) If the representative is an entity or organization, specifying who from the entity or organization plans to attend the hearing, if anyone, and in what capacity, in addition to the individual who filed the request for hearing; and
(iii) Listing the witnesses who will be providing testimony at the hearing.
(3) The notice of hearing will require CMS, the IRE, or the Part D plan sponsor that requests to attend the hearing as a participant to reply to the notice by:
(i) Acknowledging whether it plans to attend the hearing at the time and place proposed in the notice of hearing; and
(ii) Specifying who from the entity plans to attend the hearing,
(d)
(1) As specified in § 423.2000, an ALJ may require the enrollee to attend a hearing if it is necessary to decide the case.
(2) If an ALJ determines that it is necessary to obtain testimony from a person other than the enrollee, he or she may still hold a hearing to obtain that testimony, even if the enrollee has waived the right to appear. In those cases, the ALJ would give the enrollee the opportunity to appear when the testimony is given but may hold the hearing even if the enrollee decides not to appear.
(e) * * *
(3) The objection must be in writing except for an expedited hearing when the objection may be provided orally, and except that the enrollee may orally request that a non-expedited hearing be rescheduled in an emergency circumstance the day prior to or day of the hearing. The ALJ must document all oral objections to the time and place of a hearing in writing and maintain the documentation in the case files.
(4) The ALJ may change the time or place of the hearing if the enrollee has good cause.
(g) * * *
(3) * * *
(vii) The enrollee or enrollee's representative has a prior commitment that cannot be changed without significant expense.
(viii) The enrollee or enrollee's representative asserts he or she did not receive the notice of hearing and is unable to appear at the scheduled time and place.
(h)
(i)
(2) The enrollee must state the reason for the objection and state the time and/or place he or she wants an in-person or video-teleconferencing hearing to be held.
(4) When an enrollee's request for an in-person or video-teleconferencing hearing is granted and an adjudication time frame applies in accordance with § 423.2016, the ALJ issues a decision, dismissal, or remand to the IRE within the adjudication time frame specified in § 423.2016 (including any applicable extensions provided in this subpart), unless the enrollee requesting the hearing agrees to waive such adjudication timeframe in writing.
(5) The ALJ may grant the request, with the concurrence of the Chief ALJ or designee, upon a finding of good cause and will reschedule the hearing for a time and place when the enrollee may appear in person or by video-teleconference before the ALJ.
(j)
(a)
(2) The notice is mailed, transmitted, or served at least 20 calendar days before the hearing, except for expedited hearings where written notice is mailed, transmitted, or served at least 3 calendar days before the hearing, unless the enrollee or other potential participant agrees in writing to the notice being mailed, transmitted, or served fewer than 20 calendar days before the non-expedited hearing or 3 calendar days before the expedited hearing. For expedited hearings, the ALJ may orally provide notice of the hearing to the enrollee and other potential participants but oral notice must be followed by an equivalent written notice within 1 calendar day of the oral notice.
(b)
(b)
(i) A statement that the issues before the ALJ include all of the issues brought out in the coverage determination, redetermination, or reconsideration that were not decided entirely in the enrollee's favor and that were specified in the request for hearing; and
(ii) A statement of any specific new issues the ALJ will consider in accordance with § 423.2032.
(2) The notice will inform the enrollee that he or she may designate a person to represent him or her during the proceedings.
(3) The notice must include an explanation of the procedures for requesting a change in the time or place of the hearing, a reminder that the ALJ may dismiss the hearing request if the enrollee fails to appear at the scheduled hearing without good cause, and other information about the scheduling and conduct of the hearing.
(4) The enrollee will also be told if his or her appearance or that of any other witness is scheduled by video-teleconferencing, telephone, or in person. If the ALJ has scheduled the enrollee to appear at the hearing by video-teleconferencing, the notice of hearing will advise that the scheduled place for the hearing is a video-teleconferencing site and explain what it means to appear at the hearing by video-teleconferencing.
(5) The notice advises the enrollee that if he or she objects to appearing by video-teleconferencing or telephone, and wishes instead to have his or her hearing at a time and place where he or she may appear in person before the ALJ, he or she must follow the procedures set forth at § 423.2020(i) for notifying the ALJ of his or her objections and for requesting an in-person hearing.
(c)
(2) If the enrollee states that he or she did not receive the notice of hearing, a copy of the notice is sent to him or her by certified mail or other means requested by the enrollee and in accordance with OMHA procedures.
(3) The enrollee may request that the ALJ reschedule the hearing in accordance with § 423.2020(e).
(c) The ALJ makes a decision on the objections either in writing, at a prehearing conference, or at the hearing.
(a) An ALJ or attorney adjudicator may not adjudicate an appeal if he or she is prejudiced or partial to the enrollee or has any interest in the matter pending for decision.
(b) If an enrollee objects to the ALJ or attorney adjudicator assigned to adjudicate the appeal, the enrollee must notify the ALJ within 10 calendar days of the date of the notice of hearing if a non-expedited hearing is scheduled, except for expedited hearings in which the enrollee must submit written or oral notice no later than 2 calendar days after the date of the notice of hearing, or the ALJ or attorney adjudicator at any time before a decision, dismissal order, or remand order is issued if no hearing is scheduled. The ALJ or attorney adjudicator must document all oral objections in writing and maintain the documentation in the case files. The ALJ or attorney adjudicator considers the enrollee's objections and decides whether to proceed with the appeal or withdraw.
(c) If the ALJ or attorney adjudicator withdraws, another ALJ or attorney adjudicator will be assigned to adjudicate the appeal. If the ALJ or attorney adjudicator does not withdraw, the enrollee may, after the ALJ or attorney adjudicator has issued an action in the case, present his or her objections to the Council in accordance with § 423.2100 through § 423.2130. The Council will then consider whether the decision or dismissal should be revised or, if applicable, a new hearing held before another ALJ.
(d) If the enrollee objects to the ALJ or attorney adjudicator and the ALJ or attorney adjudicator subsequently withdraws from the appeal, any adjudication period that applies to the appeal in accordance with § 423.2016 is extended by 14 calendar days for a standard appeal, or 2 calendar days for an expedited appeal.
(a)
(b)
(2) The ALJ may limit testimony and argument at the hearing that are not relevant to an issue before the ALJ, that are repetitive of evidence or testimony already in the record, or that relate to an issue that has been sufficiently developed or on which the ALJ has already ruled. The ALJ may, but is not required to, provide the enrollee or representative with an opportunity to submit additional written statements and affidavits on the matter in lieu of testimony and/or argument at the hearing. The written statements and affidavits must be submitted within the time frame designated by the ALJ.
(3) If the ALJ determines that the enrollee or enrollee's representative is uncooperative, disruptive to the hearing, or abusive during the course of the hearing after the ALJ has warned the enrollee or representative to stop such behavior, the ALJ may excuse the enrollee or representative from the hearing and continue with the hearing to provide the participants with an opportunity to offer testimony and/or argument. If an enrollee or representative was excused from the hearing, the ALJ will provide the enrollee or representative with an opportunity to submit written statements and affidavits in lieu of testimony and/or argument at the hearing, and the enrollee or representative may request a recording of the hearing in accordance with § 423.2042 and respond in writing to any statements made by participants and/or testimony of the witnesses at the hearing. The written statements and affidavits must be submitted within the time frame designated by the ALJ.
(c)
(d)
(e)
(2) If the enrollee requests the continuance and an adjudication time frame applies to the appeal in accordance with § 423.2016, the adjudication period is extended by the period between the initial hearing date and the continued hearing date.
(f)
(2) If the enrollee requests the supplemental hearing and an adjudication period applies to the appeal in accordance with § 423.2016, the adjudication period is extended by the period between the initial hearing date and the supplemental hearing date.
(a)
(b)
(i) There is new and material evidence that was not available or known at the time of the determination and that may result in a different conclusion; or
(ii) The evidence that was considered in making the determination clearly shows on its face that an obvious error was made at the time of the determination.
(2)
(3)
(c)
(a) If an ALJ or attorney adjudicator believes that the written record is missing information that is essential to resolving the issues on appeal and that information can be provided only by CMS, the IRE, and/or the Part D plan sponsor, the information may be requested from the IRE that conducted the reconsideration or its successor.
(1) Official copies of redeterminations and reconsiderations that were conducted on the appealed issues can be provided only by CMS, the IRE, and/or the Part D plan sponsor. Prior to issuing a request for information to the IRE, OMHA will confirm whether an electronic copy of the missing redetermination or reconsideration is available in the official system of record, and if so will accept the electronic copy as an official copy.
(2) “Can be provided only by CMS, the IRE, and/or the Part D plan sponsor” means the information is not publicly available, is not in the possession of the enrollee, and cannot be requested and obtained by the enrollee. Information that is publicly available is information that is available to the general public via the Internet or in a printed publication. Information that is publicly available includes, but is not limited to, information available on a CMS, IRE or Part D Plan sponsor Web site or information in an official CMS or HHS publication.
(b) The ALJ or attorney adjudicator retains jurisdiction of the case, and the case remains pending at OMHA.
(c) The IRE has 15 calendar days for standard appeals, or 2 calendar days for expedited appeals, after receiving the request for information to furnish the information or otherwise respond to the information request directly or through CMS or the Part D plan sponsor.
(d) If an adjudication period applies to the appeal in accordance with § 423.2016, the adjudication period is extended by the period between the date of the request for information and the date the IRE responds to the request or 20 calendar days after the date of the request for standard appeals, or 3 calendar days after the date of the request for expedited appeals, whichever occurs first.
(a)
(b)
(i) The enrollee indicates in writing or, for expedited hearings orally or in writing, that he or she does not wish to appear before an ALJ at a hearing, including a hearing conducted by telephone or video-teleconferencing, if available. OMHA must document all oral requests not to appear at a hearing in writing and maintain the documentation in the case files; or
(ii) The enrollee lives outside the United States and does not inform OMHA that he or she wants to appear at a hearing before an ALJ.
(2) When a hearing is not held, the decision of the ALJ or attorney adjudicator must refer to the evidence in the record on which the decision was based.
(c)
(a) The ALJ may decide on his or her own, or at the request of the enrollee to the hearing, to hold a prehearing or posthearing conference to facilitate the hearing or the hearing decision.
(b) For non-expedited hearings, the ALJ informs the enrollee, and CMS, the IRE, and/or the Part D plan sponsor if the ALJ has granted their request(s) to be a participant to the hearing at the time the notice of conference is sent, of the time, place, and purpose of the conference at least 7 calendar days before the conference date, unless the enrollee indicates in writing that he or she does not wish to receive a written notice of the conference.
(c) For expedited hearings, the ALJ informs the enrollee, and CMS, the IRE, and/or the Part D plan sponsor if the ALJ has granted their request(s) to be a participant to the hearing, of the time, place, and purpose of the conference at least 2 calendar days before the conference date, unless the enrollee indicates orally or in writing that he or she does not wish to receive a written notice of the conference.
(d) All oral requests not to receive written notice of the conference must be documented in writing and the documentation must be made part of the administrative record.
(e) At the conference—
(1) The ALJ or an OMHA attorney designated by the ALJ conducts the conference, but only the ALJ conducting a conference may consider matters in addition to those stated in the conference notice, if the enrollee consents to consideration of the additional matters in writing.
(2) An audio recording of the conference is made.
(f) The ALJ issues an order to the enrollee and all participants who attended the conference stating all agreements and actions resulting from the conference. If the enrollee does not object within 10 calendar days of receiving the order for non-expedited hearings or 1 calendar day for expedited hearings, or any additional time granted by the ALJ, the agreements and actions become part of the administrative record and are binding on the enrollee.
(a)
(2) The record will include marked as exhibits, the appealed determinations and documents and other evidence used in making the appealed determinations and the ALJ's or attorney adjudicator's decision, including, but not limited to, medical records, written statements, certificates, reports, affidavits, and any other evidence the ALJ or attorney adjudicator admits. The record will also include any evidence excluded or not considered by the ALJ or attorney adjudicator, including but not limited to duplicative evidence submitted by the enrollee.
(3) An enrollee may request and receive a copy of the record prior to or at the hearing, or, if a hearing is not held, at any time before the notice of decision is issued.
(4) If a request for review is filed, the complete record, including any prehearing and posthearing conference and hearing recordings, is forwarded to the Council.
(5) A typed transcription of the hearing is prepared if an enrollee seeks judicial review of the case in a Federal district court within the stated time period and all other jurisdictional criteria are met, unless, upon the Secretary's motion prior to the filing of an answer, the court remands the case.
(b)
(2) If an enrollee requests a copy of all or part of the record from OMHA or the ALJ or attorney adjudicator and an opportunity to comment on the record, any adjudication period that applies in accordance with § 423.2016 is extended by the time beginning with the receipt of the request through the expiration of the time granted for the enrollee's response.
(3) If the enrollee requests a copy of all or part of the record and the record, including any audio recordings, contains information pertaining to an individual that the enrollee is not entitled to receive, such as personally identifiable information or protected health information, such portions of the record will not be furnished unless the enrollee obtains consent from the individual.
(a)
(2) It is within the discretion of the ALJ to grant or deny an enrollee's request for consolidation. In considering an enrollee's request, the ALJ may consider factors such as whether the issue(s) may be more efficiently decided if the appeals are consolidated for hearing. In considering the enrollee's request for consolidation, the ALJ must take into account any adjudication deadlines for each appeal and may require an enrollee to waive the adjudication deadline associated with one or more appeals if consolidation otherwise prevents the ALJ from deciding all of the appeals at issue within their respective deadlines.
(3) The ALJ may also propose on his or her own motion to consolidate two or more appeals in one hearing for administrative efficiency, but may not require an enrollee to waive the adjudication deadline for any of the consolidated cases.
(4) Notice of a consolidated hearing must be included in the notice of hearing issued in accordance with §§ 423.2020 and 423.2022.
(b)
(i) A consolidated decision and record; or
(ii) A separate decision and record on each appeal.
(2) If a separate decision and record on each appeal is made, the ALJ is responsible for making sure that any evidence that is common to all appeals and material to the common issue to be decided, and audio recordings of any conferences that were conducted and the consolidated hearing are included in each individual administrative record, as applicable.
(3) If a hearing will not be conducted for multiple appeals that are before the same ALJ or attorney adjudicator, and the appeals involve one or more of the same issues, the ALJ or attorney adjudicator may make a consolidated decision and record at the request of the enrollee or on the ALJ's or attorney adjudicator's own motion.
(c)
(a)
(i) The decision must be based on evidence offered at the hearing or otherwise admitted into the record, and
(ii) A copy of the decision should be mailed or otherwise transmitted to the enrollee at his or her last known address.
(iii) A copy of the written decision should also be provided to the IRE that issued the reconsideration determination, and to the Part D plan sponsor that issued the coverage determination.
(2)
(i) The specific reasons for the determination, including, to the extent appropriate, a summary of any clinical or scientific evidence used in making the determination;
(ii) The procedures for obtaining additional information concerning the decision; and
(iii) Notification of the right to appeal the decision to the Council, including instructions on how to initiate an appeal under this section.
(3)
(b)
(2)
(i) The specific reasons for the determination, including a summary of the evidence considered and applicable authorities;
(ii) The procedures for obtaining additional information concerning the decision; and
(iii) Notification that the decision is binding and is not subject to further review, unless reopened and revised by the ALJ or attorney adjudicator.
(c)
(a) The decision of the ALJ or attorney adjudicator on a request for hearing is binding unless—
(1) An enrollee requests a review of the decision by the Council within the stated time period or the Council reviews the decision issued by an ALJ or attorney adjudicator under the procedures set forth in § 423.2110, and the Council issues a final decision or remand order;
(2) The decision is reopened and revised by an ALJ or attorney adjudicator or the Council under the procedures explained in § 423.1980;
(3) The expedited access to judicial review process at § 423.1990 is used;
(4) The ALJ's or attorney adjudicator's decision is a recommended decision directed to the Council and the Council issues a decision; or
(5) In a case remanded by a Federal district court, the Council assumes jurisdiction under the procedures in § 423.2138 and the Council issues a decision.
(b) The decision of the ALJ or attorney adjudicator on a request for review of an IRE dismissal is binding on the enrollee unless the decision is reopened and revised by the ALJ or attorney adjudicator under the procedures explained in § 423.1980.
(a)
(1) Neither the enrollee that requested the hearing nor the enrollee's representative appears at the time and place set for the hearing, if—
(i) The enrollee was notified before the time set for the hearing that the request for hearing might be dismissed for failure to appear, the record contains documentation that the enrollee acknowledged the notice of hearing, and the enrollee does not contact the ALJ within 10 calendar days after the hearing for non-expedited hearings and 2 calendar days after the hearing for expedited hearings, or does contact the ALJ but the ALJ determines the enrollee did not demonstrate good cause for not appearing; or
(ii) The record does not contain documentation that the enrollee acknowledged the notice of hearing, the ALJ sends a notice to the enrollee at his or her last known address asking why the enrollee did not appear, and the enrollee does not respond to the ALJ's notice within 10 calendar days for non-expedited hearings or within 2 calendar days for expedited hearings after receiving the notice, or does contact the ALJ but the ALJ determines the enrollee did not demonstrate good cause for not appearing. For expedited hearings, an enrollee may submit his or her response orally to the ALJ.
(iii) In determining whether good cause exists under paragraphs (a)(1)(i) and (ii) of this section, the ALJ considers any physical, mental, educational, or linguistic limitations (including any lack of facility with the English language) the enrollee may have.
(2) The person requesting a hearing has no right to it under § 423.2002.
(3) The enrollee did not request a hearing within the stated time period and the ALJ or attorney adjudicator has not found good cause for extending the deadline, as provided in § 423.2014(e).
(4) The enrollee died while the request for hearing is pending and the request for hearing was filed by the enrollee or the enrollee's representative, and the enrollee's surviving spouse or estate has no remaining financial interest in the case and the enrollee's representative, if any, does not wish to continue the appeal.
(5) The ALJ or attorney adjudicator dismisses a hearing request entirely or refuses to consider any one or more of the issues because an IRE, an ALJ or attorney adjudicator, or the Council has made a previous determination or decision under this subpart about the enrollee's rights on the same facts and on the same issue(s), and this previous determination or decision has become binding by either administrative or judicial action.
(6) The enrollee abandons the request for hearing. An ALJ or attorney adjudicator may conclude that an enrollee has abandoned a request for hearing when OMHA attempts to schedule a hearing and is unable to contact the enrollee after making reasonable efforts to do so.
(7) The enrollee's request is not complete in accordance with § 423.2014(a)(1), even after the enrollee is provided with an opportunity to complete the request.
(b)
(1) The enrollee has no right to a review of the IRE dismissal under § 423.2004.
(2) The enrollee did not request a review within the stated time period and the ALJ or attorney adjudicator has not found good cause for extending the deadline, as provided in § 423.2014(e).
(3) The enrollee died while the request for review was pending and the request was filed by the enrollee or the enrollee's representative, and the enrollee's surviving spouse or estate has no remaining financial interest in the case and the enrollee's representative, if any, does not wish to continue the appeal.
(4) The enrollee's request is not complete in accordance with § 423.2014(a)(1), even after the enrollee is provided with an opportunity to complete the request.
(c)
(d)
(e)
(a) The dismissal of a request for a hearing is binding, unless it is vacated by the Council under § 423.2108(b), or vacated by the ALJ or attorney adjudicator under § 423.2052(e).
(b) The dismissal of a request for review of an IRE dismissal of a request for reconsideration is binding and not subject to further review unless vacated by the ALJ or attorney adjudicator under § 423.2052(e).
(a)
(2) If the IRE does not furnish the case file for an appealed reconsideration, an ALJ or attorney adjudicator may issue a remand directing the IRE to reconstruct the record or, if it is not able to do so, initiate a new appeal adjudication.
(3) If the IRE or Part D plan sponsor is able to reconstruct the record for a remanded case and returns the case to OMHA, the case is no longer remanded and the reconsideration is no longer vacated, and any adjudication period that applies to the appeal in accordance with § 423.2016 is extended by the period between the date of the remand and the date that case is returned to OMHA.
(b)
(c)
(2)
(d)
(e)
(f)
(g)
A remand of a request for hearing or request for review is binding unless vacated by the Chief ALJ or a designee in accordance with § 423.2056(g).
(a) All laws and regulations pertaining to the Medicare program, including, but not limited to Titles XI, XVIII, and XIX of the Social Security Act and applicable implementing regulations, are binding on ALJs and attorney adjudicators, and the Council.
(b) CMS Rulings are published under the authority of the CMS Administrator. Consistent with § 401.108 of this chapter, rulings are binding on all CMS components, and on all HHS components that adjudicate matters under the jurisdiction of CMS.
(c) Precedential decisions designated by the Chair of the Departmental Appeals Board in accordance with § 401.109 of this chapter are binding on all CMS components, and all HHS components that adjudicate matters under the jurisdiction of CMS.
(a) Consistent with § 423.1974, the enrollee may request that the Council review an ALJ's or attorney adjudicator's decision or dismissal.
(b) When the Council reviews an ALJ's or attorney adjudicator's written decision, it undertakes a de novo review.
(c) The Council issues a final decision, dismissal order, or remands a case to the ALJ or attorney adjudicator no later than the end of the 90 calendar day period beginning on the date the request for review is received (by the entity specified in the ALJ's or attorney adjudicator's written notice of decision), unless the 90 calendar day period is extended as provided in this subpart or the enrollee requests expedited Council review.
(d) If an enrollee requests expedited Council review, the Council issues a final decision, dismissal order or remand as expeditiously as the enrollee's health condition requires, but no later than the end of the 10 calendar day period beginning on the date the request for review is received (by the entity specified in the ALJ's or attorney adjudicator's written notice of decision), unless the 10 calendar day period is extended as provided in this subpart.
(a)(1) An enrollee may request Council review of a decision or dismissal issued by an ALJ or attorney adjudicator if the enrollee files a written request for a Council review within 60 calendar days after receipt of the ALJ's or attorney adjudicator's written decision or dismissal.
(2) An enrollee may request that Council review be expedited if the appeal involves an issue specified in § 423.566(b) but does not include solely a request for payment of Part D drugs already furnished.
(i) If an enrollee is requesting that the Council review be expedited, the enrollee submits an oral or written request within 60 calendar days after the receipt of the ALJ's or attorney adjudicator's written decision or dismissal. A prescribing physician or other prescriber may provide oral or written support for an enrollee's request for expedited review.
(ii) The Council must document all oral requests for expedited review in writing and maintain the documentation in the case files.
(3) For purposes of this section, the date of receipt of the ALJ's or attorney adjudicator's written decision or dismissal is presumed to be 5 calendar days after the date of the notice of the decision or dismissal, unless there is evidence to the contrary.
(4) The request is considered as filed on the date it is received by the entity specified in the notice of the ALJ's or attorney adjudicator's action.
(b) An enrollee requesting a review may ask that the time for filing a request for Council review be extended if—
(1) The request for an extension of time is in writing or, for expedited reviews, in writing or oral. The Council must document all oral requests in writing and maintain the documentation in the case file.
(2) The request explains why the request for review was not filed within the stated time period. If the Council finds that there is good cause for missing the deadline, the time period will be extended. To determine whether good cause exists, the Council uses the standards outlined at § 405.942(b)(2) and (3) of this chapter.
(c) An enrollee does not have the right to seek Council review of an ALJ's or attorney adjudicator's remand to an IRE, or an ALJ's or attorney adjudicator's affirmation of an IRE's dismissal of a request for reconsideration, or dismissal of a request to review an IRE dismissal.
(a)
(b)
(i) CMS or the IRE participated or requested to participate in the appeal at the OMHA level; and
(ii) In CMS' or the IRE's view, the ALJ's or attorney adjudicator's decision or dismissal is not supported by the preponderance of evidence in the record or the ALJ or attorney adjudicator abused his or her discretion.
(2) CMS' or the IRE's referral to the Council is made in writing and must be filed with the Council no later than 60 calendar days after the ALJ's or attorney adjudicator's written decision or dismissal is issued.
(i) The written referral will state the reasons why CMS or the IRE believes that the Council should review the case on its own motion.
(ii) CMS or the IRE will send a copy of its referral to the enrollee and to the OMHA Chief ALJ.
(iii) The enrollee may file exceptions to the referral by submitting written comments to the Council within 20 calendar days of the referral notice.
(iv) An enrollee submitting comments to the Council must send the comments to CMS or the IRE.
(c)
(2)
(d)
(2) The Council may adopt, modify, or reverse the decision or dismissal, may remand the case to an ALJ or attorney adjudicator for further proceedings, or may dismiss a hearing request.
(3) The Council must issue its action no later than 90 calendar days after receipt of the CMS or the IRE referral, unless the 90 calendar day period has been extended as provided in this subpart.
(4) The Council may not issue its action before the 20 calendar day comment period has expired, unless it determines that the agency's referral does not provide a basis for reviewing the case.
(5) If the Council declines to review a decision or dismissal on its own motion, the ALJ's or attorney adjudicator's decision or dismissal is binding.
Secs. 1102 and 1871 of the Social Security Act (42 U.S.C. 1302 and 1395hh).
(a)
(c)
(2) The following part 405 regulations, and any references thereto, specifically do not apply under this subpart:
(i) Section 405.950 (time frames for making a redetermination).
(ii) Section 405.970 (time frames for making a reconsideration following a contractor redetermination, including the option to escalate an appeal to the OMHA level).
(iii) Section 405.1016 (time frames for deciding an appeal of a QIC reconsideration, or escalated request for a QIC reconsideration, including the option to escalate an appeal to the Council).
(iv) The option to request that an appeal be escalated from the OMHA level to the Council as provided in § 405.1100(b), and time frames for the Council to decide an appeal of an ALJ's or attorney adjudicator's decision or an appeal that is escalated from the OMHA level to the Council as provided in § 405.1100(c) and (d).
(v) Section 405.1132 (request for escalation to Federal court).
(vi) Sections 405.956(b)(8), 405.966(a)(2), 405.976(b)(5)(ii), 405.1018(c), 405.1028(a), and 405.1122(c), and any other reference to requiring a determination of good cause for the introduction of new evidence by a provider, supplier, or a beneficiary represented by a provider or supplier.
(a)
(b)
(2) The date of receipt of the notice of the reconsidered determination is presumed to be 5 calendar days after the date on the notice, unless there is evidence to the contrary.
(3) A request is considered filed on the date it is received by OMHA.
(a) After an individual appellant has submitted a request for a hearing, the ALJ or attorney adjudicator determines the amount in controversy in accordance with § 405.1006(d) and (e) of this chapter. When two or more appellants submit a request for hearing, the ALJ or attorney adjudicator determines the amount in controversy in accordance with § 405.1006(d) and (e) of this chapter.
(b) If the ALJ or attorney adjudicator determines that the amount in controversy is less than $200, the ALJ,
(c) At the end of the 15-day period, if an ALJ determines that the amount in controversy is less than $200, the ALJ, without holding a hearing dismisses the request for a hearing without ruling on the substantive issues involved in the appeal and notifies the parties and the QIO that the QIO reconsidered determination is conclusive for Medicare payment purposes.
(a) The circumstances under which the Medicare Appeals Council (Council) will review an ALJ's or attorney adjudicator's decision or dismissal are the same as those set forth at §§ 405.1102 (“Request for Council review when ALJ or attorney adjudicator issues decision or dismissal”) and 405.1110 (“Council reviews on its own motion”) of this chapter.
(b) If $2,000 or more is in controversy, a party may obtain judicial review of a Council decision, or an ALJ's or attorney adjudicator's decision if a request for review by the Council was denied, by filing a civil action under the Federal Rules of Civil Procedure within 60 days after the date the party received notice of the Council decision or denial.
(b)
(c)
Environmental Protection Agency (EPA).
Final rule.
The Environmental Protection Agency (EPA) is taking final action to revise certain portions of the National Emission Standards for Hazardous Air Pollutants (NESHAP) for Radon Emissions from Operating Mill Tailings. The revisions for this final action are based on the EPA's determination as to what constitutes generally available control technology or management practices (GACT) for this area source category. We are also adding new definitions to the NESHAP, revising existing definitions and clarifying that the NESHAP also applies to uranium recovery facilities that extract uranium through the in-situ leach method and the heap leach method.
This rule is effective on March 20, 2017.
The EPA has established a docket for this action under Docket ID No. EPA-HQ-OAR-2008-0218. All documents in the docket are listed on the
Dan Schultheisz, Office of Radiation and Indoor Air, Radiation Protection Division, Mail code 6608T, U.S. Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460; telephone number: 202-343-9290; fax number: 202-343-2304; email address:
Throughout this document, “we,” “us” and “our” refer to the EPA.
Preamble Acronyms and Abbreviations. We use the following acronyms and abbreviations in this document:
This final rule amends requirements promulgated in 1989 under the Clean Air Act to control emissions of radon-222 from operating structures used to manage uranium byproduct material or tailings
Uranium recovery and processing currently occurs by one of three methods: (1) Conventional milling; (2) in-situ leach (ISL); and (3) heap leach. A conventional uranium mill is a chemical plant that extracts uranium from ore that has typically been obtained from an underground or open-pit mine. The ore is crushed and the uranium leached using chemical solutions, concentrated into uranium oxide (U
ISL is often used when a uranium ore body is in a formation through which ground water flows. A liquid solution containing chemicals can be injected into the formation to mobilize the uranium into solution, which is then recovered and processed. Process liquids and effluents from ISL are managed in non-conventional impoundments. ISL is now the predominant form of uranium recovery in the United States.
Heap leaching is a method of processing that is expected to be used for low-grade ore or in other situations where it is economically favorable. During heap leaching a pile of ore is sprayed with a chemical solution and uranium leaches into solution. The uranium solution is collected at the bottom of the pile and further processed. At the end of processing, the heap leach pile may be closed in place (typically by being covered), or removed and placed in a conventional impoundment. Process liquids and effluents are managed in non-conventional impoundments. At the time of this rulemaking, there are no heap leach facilities in the United States, although one such facility is planned.
There is currently one operating conventional mill in the United States, the White Mesa Mill in Utah. Two other conventional mills remain on standby, the Shootaring Canyon Mill in Utah and the Sweetwater Mill in Wyoming. There are six operating ISL facilities: Crow Butte in Nebraska; Smith Ranch, Lost Creek, Nichols Ranch, Willow Creek (which includes the Irigary and Christensen Ranch wellfields) and Ross CPP, all in Wyoming. Four other ISL facilities have operated and are now in standby. They are Alta Mesa, Kingsville Dome,
Subpart W was initially promulgated in 1986 and amended pursuant to a voluntary remand in 1989. For CAA section 112 standards that were in effect before November 15, 1990, CAA section 112(q)(1) requires the EPA to review, and, if appropriate, revise such standards to comply with the requirements of subsection (d). As a result of this review, we are promulgating this final rule pursuant to
Subpart W regulates facilities and materials that are also regulated under the authority of the Uranium Mill Tailings Radiation Control Act of 1978 (UMTRCA). UMTRCA directed the EPA to establish standards of general application to protect public health, safety and the environment from hazards associated with wastes from extraction or concentration of uranium or thorium. The Nuclear Regulatory Commission (NRC) implements and enforces the EPA's standards through its licensing and regulatory program. By establishing requirements to control radon emissions from uranium byproduct material or tailings during the facility's operational period, Subpart W supports and works in harmony with the NRC's UMTRCA-based provisions that limit radon concentrations at the site boundary.
When promulgated in 1989, Subpart W established monitoring requirements and work practices as methods to control radon emissions from impoundments used to manage uranium byproduct material or tailings (51 FR 51654, December 15, 1989). Existing impoundments (those operating as of December 15, 1989) were required to comply with a radon flux standard of 20 pCi/m
• Phased disposal in impoundments no larger than 40 acres in area, with no more than two such impoundments operating at any one time; or
• Continuous disposal of tailings such that tailings are dewatered and immediately disposed with no more than 10 acres of tailings exposed at any one time.
All impoundments were required to be operated to comply with the requirements of 40 CFR 192.32(a),
This final rule defines and establishes GACT-based standards for conventional and non-conventional impoundments and heap leach piles; in doing so, the final rule clarifies the applicability of the 1989 rule to these different types of units and distinguishes among them. The final rule retains the radon flux standard and monitoring requirements for conventional impoundments in existence on December 15, 1989, and retains the provision that extended the construction requirements in 40 CFR 192.32(a)(1) to these conventional impoundments. The final rule also formalizes the 1989 management practices as GACT-based standards for conventional impoundments constructed after December 15, 1989, with limited changes to the 1989 standard—the final rule focuses the cross-reference regarding the impoundment construction requirements to 40 CFR 192.32(a)(1), instead of a more broad reference to 40 CFR 192.32(a) and removes the phrase “as determined by the Nuclear Regulatory Commission.” In addition, the final rule establishes GACT-based standards for non-conventional impoundments and heap leach piles, as follows:
• Non-conventional impoundments must maintain solid materials in a saturated condition, with no solid materials visible above the level of liquid in the impoundment;
• Heap leach piles that have completed their operational life but not yet entered closure are limited to no more than two such piles with an area no greater than 40 acres each; and
• Conformance to the construction requirements in 40 CFR 192.32(a)(1).
The final rule changes some existing definitions and adds several new definitions. The amended definition of “operation” is finalized as proposed. The definitions of “continuous disposal,” “dewatered,” “existing impoundment,” and “phased disposal” are amended to conform to the amended definition of “operation.” New definitions of “standby,” “conventional impoundment,” “non-conventional impoundment,” “heap leach pile,” “heap leach pile operational life,” and “uranium recovery facility” are also being finalized as proposed. New definitions of “final closure” and “reclamation plan” are added to the final rule to clarify when Subpart W no longer applies to an impoundment or heap leach pile.
The proposed rule contained several provisions that are modified in the final rule in response to public comments. We proposed to eliminate the radon flux standard and monitoring requirement for impoundments in existence on December 15, 1989. We believed this was appropriate based on information that indicated that the remaining impoundments in this category could comply with the GACT-based management practices. Information received through public comments demonstrated that the assumptions that supported our proposal were not correct and also that the pre-1989 unit that was expected to close (Cell 3 at the White Mesa Mill) remains open. Therefore, the final rule retains the radon flux standard and monitoring requirement for conventional impoundments in existence on December 15, 1989.
We proposed that non-conventional impoundments maintain one meter of liquid above any solid materials in the impoundment. Our analyses indicate that liquids effectively attenuate radon emissions, and that one meter of liquid would reduce the radon emissions by greater than 99%, to a level nearly indistinguishable from background. Based on public comment regarding feasibility and cost associated with the
We proposed that heap leach piles be regulated under Subpart W from the time they begin processing (
This final rule will have limited economic impact. No new requirements are placed on conventional impoundments. Further, impacts associated with non-conventional impoundments and heap leach piles will be less than those estimated for the proposed rule. Operators of non-conventional impoundments and heap leach piles will not incur additional cost related to liners, which are required by other regulations. Operators of non-conventional impoundments will be required to maintain liquids in the impoundment such that no solids are visible above the liquid level. In addition, operators of heap leach facilities can reduce the period of time they are subject to Subpart W and thus reduce compliance costs by expeditiously beginning the closure process after the operational life of the pile has ended, and we encourage timely closure in all cases.
Table 1 presents a summary of the unit cost (per pound of U
Based on the information in Table 1, the four GACT-based standards represent about 4%, 6%, and 5% of the baseline cost (per pound of U
During development of the proposed rule and throughout the public comment period, the EPA engaged with stakeholders and sought public input. Subsequent to beginning the rulemaking process, the EPA entered into a settlement agreement in August 2009 with Colorado Citizens Against Toxic Waste (CCAT) and Rocky Mountain Clean Air Action. As part of the settlement agreement, the EPA agreed to:
• Provide three public presentations and a national webinar on the rulemaking;
• Conduct quarterly stakeholder conference calls on the status of the rulemaking; and
• Create a public Web site and post non-privileged records.
The EPA conducted public presentations in June 2009 in Cañon City, Colorado, near the Cotter Mill; in October 2009 in Rapid City, South Dakota, in conjunction with the Western Mining Action Network's semi-annual conference; and in May 2010 on lands of the Ute Mountain Ute Tribe in southeastern Utah, near the White Mesa Mill. The EPA also presented a national webinar in June 2010. Records of EPA's quarterly stakeholder calls and non-privileged records regarding this Subpart W rulemaking are available at the following public Web site:
In addition to the presentations specified in the settlement agreement, the EPA conducted presentations at numerous industry-sponsored events, particularly the annual uranium recovery workshop sponsored by the NRC and the National Mining Association (NMA). Beginning in 2009, the EPA provided regular updates on the Subpart W rulemaking at these annual workshops. The EPA also provided a presentation for NMA
The EPA also actively sought interactions with tribal stakeholders. Several current or proposed uranium recovery facilities are of interest to tribes. The White Mesa Mill is located just north of Ute Mountain Ute lands in southeastern Utah. The Oglala Sioux Tribe has been active in the renewal of the operating license for the Crow Butte ISL facility in northwestern Nebraska and the initial licensing of the proposed Dewey-Burdock ISL facility in southwestern South Dakota. The Navajo Nation has been active in the development of proposed ISL facilities in New Mexico.
The EPA conducted presentations at the Uranium Contamination Stakeholder Workshops in 2009 and 2010 in Gallup, New Mexico and Tuba City, Arizona, respectively. In addition to the presentations, the EPA also held discussions with representatives from the Navajo EPA and the Hopi Tribe. In June 2014, after the proposed rule was published, the EPA gave a presentation for the National Tribal Air Association (NTAA) on the monthly NTAA/EPA policy call.
Concurrent with issuance of the 2014 proposed rule, the EPA sent letters to 53 tribal leaders offering consultation on the rule, consistent with the EPA's “Policy on Consultation and Coordination with Indian Tribes.” Consultation is a process of meaningful communication and coordination between the EPA and tribal officials prior to the EPA taking actions or implementing decisions that may affect tribes. The Ute Mountain Ute Tribe responded and requested a formal consultation. The consultation was held in July 2014 between officials of the EPA's Office of Radiation and Indoor Air in Washington, DC and officials from EPA Region 8 and the Tribe at Tribal headquarters in Towaoc, Colorado (Docket No. EPA-HQ-OAR-2008-0218-0120).
The EPA has also met with individual stakeholder groups. Prior to publication of the proposed rule, the EPA met with representatives from CCAT, Uranium Watch, and the Sheep Mountain Alliance. Following publication of the proposed rule, the EPA met with the Southern Environmental Law Center. Concurrent with public hearings in September 2014, the EPA met with representatives from CCAT and the Energy Minerals Law Center. Following the public comment period, in November 2014 the EPA met with representatives from Uranium Watch and the Information Network for Responsible Mining (INFORM).
The regulated categories and entities potentially affected by the final standards are shown below in Table 2:
This table is not intended to be exhaustive, but rather provides a guide for readers regarding entities likely to be affected by this final action. If you have any questions regarding the applicability of this action to a particular entity, consult either the air permit authority for the entity or your EPA regional representative as listed in 40 CFR 61.04 of subpart A (General Provisions).
In addition to being available in the docket, an electronic copy of this final action will also be available on the Internet. Following signature, a copy of this final action will be posted at the following address:
Under CAA section 307(b)(1), judicial review of this final action is available only by filing a petition for review in the United States Court of Appeals for the District of Columbia Circuit by March 20, 2017. Under CAA section 307(b)(2), the requirements established by this final rule may not be challenged separately in any civil or criminal proceedings brought by the EPA to enforce the requirements.
Section 307(d)(7)(B) of the CAA further provides that “[o]nly an objection to a rule or procedure which was raised with reasonable specificity during the period for public comment (including any public hearing) may be raised during judicial review.” This section also provides a mechanism for the EPA to reconsider the rule “[i]f the person raising an objection can demonstrate to the Administrator that it was impracticable to raise such objection within [the period for public comment] or if the grounds for such objection arose after the period for public comment (but within the time specified for judicial review) and if such objection is of central relevance to the outcome of the rule.” Any person seeking to make such a demonstration should submit a Petition for Reconsideration to the Office of the Administrator, U.S. EPA, Room 3000, EPA WJC West Building, 1200 Pennsylvania Ave. NW., Washington, DC 20460, with a copy to both the person(s) listed in the preceding
Section 112(q)(1) of the Clean Air Act (CAA) requires that NESHAPs “in effect before the date of enactment of the Clean Air Act Amendments of 1990 [Nov. 15, 1990] . . . shall be reviewed and, if appropriate, revised, to comply with the requirements of subsection (d) of . . . section [112].” The EPA promulgated 40 CFR part 61, subpart W, “National Emission Standards for Radon Emissions from Operating Mill
Section 112(d) of the CAA requires the EPA to establish emission standards for major and area sources. A major source is any stationary source that emits or has the potential to emit 10 tons per year (tpy) or more of any single HAP or 25 tpy or more of any combination of HAPs. An area source is a stationary source of HAP that is not a major source. For operating uranium byproduct material or tailings impoundments, the HAP of concern is radon-222 (hereafter referred to as “radon” or Rn-222). Radon emissions from operating uranium recovery facilities are far below the statutory thresholds
Section 112(q)(1) does not dictate how the EPA must conduct its review of those NESHAPs issued prior to 1990. Rather, it provides that the Agency must review, and, if appropriate, revise the standards to comply with the requirements of section 112(d). Determining what revisions, if any, are appropriate for these NESHAPs is best assessed through a case-by-case consideration of each NESHAP. As explained below, in this case, we have reviewed Subpart W and are revising the standards consistent with section 112(d)(5), which addresses standards for area sources. After our review, we determined it was appropriate to revise Subpart W to clarify the applicability of the rule to non-conventional impoundments and heap leach piles and promulgate standards that are more appropriate for controlling radon emissions at those sources, consistent with the requirements of CAA section 112(d)(5). All units regulated by Subpart W are area sources and we determined that promulgating GACT-based standards under CAA section 112(d)(5) is appropriate for these sources.
For area sources, the Administrator has the discretion under CAA section 112(d)(5) to set standards based on GACT in lieu of maximum achievable control technology (MACT) under sections 112(d)(2) and (d)(3), which is required for major sources. Under CAA section 112(d)(5), the Administrator may elect to promulgate standards or requirements for area sources “which provide for the use of generally available control technologies or management practices by such sources to reduce emissions of hazardous air pollutants.” Consistent with section 112(d)(5), we are revising Subpart W to reflect GACT-based standards.
The source category regulated under Subpart W, first defined in 1986, is facilities licensed to manage uranium byproduct material during and following the processing of uranium ores, commonly referred to as uranium mills and their associated tailings. Licenses are issued by the U.S. Nuclear Regulatory Commission (NRC) or NRC Agreement States. As promulgated in 1986 and 1989, Subpart W defines “uranium byproduct material or tailings” as “the waste produced by the extraction or concentration of uranium from any ore processed primarily for its source material content.”
Subpart W was initially promulgated on September 24, 1986 (51 FR 34056) and amended pursuant to a voluntary remand on December 15, 1989 (54 FR 51654). At the time of promulgation in the 1980s, the predominant form of uranium recovery was through the use of conventional mills. As promulgated in 1989, Subpart W contained two separate standards. The first standard applied to “existing” impoundments,
The method for monitoring for compliance with the radon flux standard was prescribed as Method 115, found at 40 CFR part 61, Appendix B. The owners or operators of existing impoundments were required to report to the EPA the results of the compliance testing for any calendar year by no later than March 31 of the following year.
There is currently one operating mill with impoundments that pre-date December 15, 1989, and two mills that are currently in standby mode. All of
The second standard applied to “new” impoundments constructed after December 15, 1989. The requirements applicable to new impoundments were work practice standards that regulated either the size and number of impoundments, or the amount of tailings that may remain uncovered at any time. After December 15, 1989, “no new tailings impoundment can be built unless it is designed, constructed and operated to meet one of the following two work practices:
1. Phased disposal in lined tailings impoundments that are no more than 40 acres in area and meet the requirements of 40 CFR 192.32(a) as determined by the Nuclear Regulatory Commission. The owner or operator shall have no more than two impoundments, including existing impoundments, in operation at any one time.
2. Continuous disposal of tailings such that tailings are dewatered and immediately disposed with no more than 10 acres uncovered at any time and operated in accordance with § 192.32(a) as determined by the Nuclear Regulatory Commission.”
The basis of the work practice standards was to (1) limit the size of the impoundment, which limits the radon source; or (2) use the continuous disposal system, which prohibits large accumulations of dewatered uncovered uranium byproduct material or tailings, limiting the amount of radon released.
Pursuant to CAA Section 112(d)(5), in the May 2, 2014 notice we proposed GACT-based standards for the affected sources at conventional uranium mills, ISL facilities and heap leach facilities. Subpart W has always applied to these sources; however, given the evolution of uranium recovery facilities over the last 20 years, we thought it appropriate to revise Subpart W to tailor the requirements of the NESHAP to the different types of facilities in existence at this time and reaffirm Subpart W's applicability to these facilities. For the conventional impoundments the GACT-based standards were based upon the requirements established in 1989. We also proposed to revise Subpart W to add appropriate definitions, standards and other requirements that are more applicable to HAP emissions at these different types of uranium recovery facilities. Specifically, we proposed to:
• Remove monitoring requirements for impoundments constructed prior to December 15, 1989 and to have these “existing” impoundments demonstrate compliance with the proposed GACT-based standards;
• clarify that any impoundment at a uranium recovery facility that contained uranium byproduct materials or tailings is regulated under Subpart W and subject to the liner requirements referenced at 40 CFR 192.32(a)(1), including “evaporation” or “holding” ponds;
• establish as GACT-based standards that these “non-conventional” or liquid-holding impoundments meet the design and construction requirements of 40 CFR 192.32(a)(1), with no size/area restriction or monitoring requirement, and that during the active life of the pond at least one meter of liquid be maintained in the pond;
• establish as GACT-based standards that heap leach piles meet the phased disposal management practice standard (which limits an owner/operator to no more than two operating heap leach piles of no more than 40 acres each at any time) and the design and construction requirements at 40 CFR 192.32(a)(1) as GACT-based standards, and maintain minimum moisture content of 30%;
• add a definition of “standby” to clarify the term and how it relates to the operational phase of an impoundment;
• amend the definition of “operation” of an impoundment so that it is clear when the owner or operator is subject to the requirements of Subpart W;
• add definitions of “conventional impoundment,” “non-conventional impoundment,” “heap leach pile,” “uranium recovery facility” and “heap leach pile operational life” to be consistent with the GACT-based standards;
• determine whether Subpart W adequately addresses protection from extreme weather events;
• revise 40 CFR 61.252(b) and (c) to accurately reflect that it is only 40 CFR 192.32(a)(1) that is applicable to Subpart W; and
• remove the phrase “as determined by the Nuclear Regulatory Commission” in 40 CFR 61.252(b)(1) and (2).
The public comment period began on May 2, 2014 and was originally proposed to end on July 31, 2014. The comment period was extended by public request until October 29, 2014. We held two days of public hearings in Denver, CO on September 4 and 5, 2014. During the public comment period for the proposed rule, the EPA met with tribal leaders from the Ute Mountain Ute Tribe, consistent with the “EPA Policy on Consultation and Coordination with Indian Tribes” (
The EPA received approximately 45 separate sets of comments on the proposed rule, including multiple submittals by the same author(s). The comments range in size from one page to several hundred pages, and in many cases contain dozens of individual comments. All told the EPA identified over 4,000 individual comments. A mass mailer that contains over one thousand signatures is also in the docket for this rulemaking (Docket No. EPA-HQ-OAR-2008-0218). The docket also includes the transcripts of the two public hearings held in Denver, CO on September 4 and 5, 2014. All of the comments received are in the docket for this rulemaking. All comments can be accessed electronically through the Federal Document Management System (FDMS), available at
There are two primary mechanisms by which we explain the issues raised in public comments and our reactions to them. First, we discuss broad or major comments in the following sections of this document. Second, we are including in the docket a document, accompanying this action, entitled “Summary of Public Comments and Responses.” The Response to Comments document addresses all other significant comments on the proposal. We gave all the relevant comments we received, whether written or oral, consideration in developing the final rule.
This action finalizes the EPA's determinations pursuant to its review of
We determined that the management practices promulgated in 1989 for conventional impoundments constructed after December 15, 1989 remain suitable for controlling radon from uranium byproduct material or tailings. We also concluded that these management practices qualify as elements of GACT-based standards for these impoundments. We further determined that there are management practices which constitute generally available control technologies that could be applied to non-conventional impoundments and heap leach piles. The final rule establishes the following elements as GACT-based standards for conventional impoundments constructed after December 15, 1989, non-conventional impoundments and heap leach piles:
• Construction of all impoundments containing or managing uranium byproduct material in accordance with the requirements in 40 CFR 192.32(a)(1);
• Operation of conventional impoundments in accordance with either the phased disposal or continuous disposal method;
• Operation of non-conventional impoundments such that solid materials in the impoundment are not visible above the liquid level, to be verified by daily visual inspection and documented by digital photograph no less frequently than weekly; and
• Maintenance of heap leach piles that have completed their operational life but have not yet entered closure in accordance with the phased disposal method (piles no larger than 40 acres in area and no more than two such piles at any time).
For conventional impoundments constructed before December 15, 1989, we retained the radon flux standard originally promulgated in 1989, and retained the requirement that the impoundments comply with the construction requirements in 40 CFR 192.32(a)(1), notwithstanding the exemption in § 192.32(a)(1) for impoundments constructed prior to the promulgation of 40 CFR part 192.
We are making revisions to several existing definitions and references, deleting a phrase and providing several new definitions. These revisions are:
• The definition of “operation” is revised as proposed;
• The definitions of “continuous disposal,” “dewatered,” “existing impoundment,” and “phased disposal” are revised to conform to the revised definition of “operation”;
• Definitions of “standby,” “conventional impoundment,” “non-conventional impoundment,” “heap leach pile,” “uranium recovery facility,” and “heap leach pile operational life” are added as proposed, with minor conforming changes;
• The reference in the 1989 rule at 40 CFR 61.252(b) and (c) is revised to 40 CFR 192.32(a)(1), as proposed, to clarify that the liner requirements are the portion of interest; as finalized, the reference to 40 CFR 192.32(a)(1) is included in § 261.252(a)(2)(i), (a)(2)(ii), (b) & (c) and the reference at § 61.252(c) in the 1989 rule is incorporated into § 61.252(a)(1) in the final rule;
• The phrase “as determined by the Nuclear Regulatory Commission” is eliminated from 40 CFR 61.252(b)(1) and (2), as proposed (§ 61.252(a)(2)(i) and (ii) in the final rule);
• The definition of “final closure” is added for completeness and clarity, in response to comments regarding the applicability of Subpart W; and
• The definition of “reclamation plan” is added to further clarify the concept of closure.
New and existing affected sources are required to comply with the existing requirements of the General Provisions (40 CFR part 61, subpart A). The General Provisions include specific requirements for notifications, recordkeeping and reporting, including provisions for notification of construction and/or modification and startup as required by 40 CFR 61.07, 61.08 and 61.09.
We are also requiring that all affected sources maintain certain records pertaining to the design, construction and operation of conventional impoundments, non-conventional impoundments and heap leach piles. These records must be retained at the facility and contain information demonstrating that the impoundments and/or heap leach pile meet the requirements in 40 CFR 192.32(a)(1), including but not limited to, all tests performed that prove the liner is compatible with the material(s) being placed on the liner. For non-conventional impoundments, this requirement also includes records showing compliance with the requirement to maintain liquid in the impoundment such that solid materials are not visible above the liquid.
Because we are retaining the radon flux standard for conventional impoundments in existence on December 15, 1989, we are also retaining the associated reporting requirements at 40 CFR 61.254 and these units must also comply with the revised recordkeeping requirements at 40 CFR 61.255, as applicable.
Because we are promulgating new recordkeeping requirements for uranium recovery facilities, we are required by the Paperwork Reduction Act (PRA) to prepare an estimate of the burden of such record-keeping on the regulated entity, in both cost and hours necessary to comply with the requirements. We have submitted the Information Collection Request (ICR) containing this burden estimate and other supporting documentation to the Office of Management and Budget (OMB). See Section VII.B for more discussion of the PRA and ICR.
We believe the record-keeping requirements promulgated today will not create a significant burden for operators of uranium recovery facilities. As described earlier, we are requiring retention of two types of records: (1) Records demonstrating that the impoundments and/or heap leach pile meet the requirements in § 192.32(a)(1) (
Documents demonstrating that the affected sources comply with § 192.32(a)(1) requirements are necessary for the facility to obtain regulatory approval from the NRC (or an NRC Agreement State) and the EPA to construct and operate the affected sources (this includes any revisions during the period of operations). Therefore, these records will exist independent of Subpart W requirements and will not need to be continually updated as a result of this record-keeping requirement in Subpart W; however, we are including this record-keeping requirement in Subpart W to require that the records be maintained at the facility and available for inspection during its operational lifetime (in some cases the records might be stored at a location away from the facility, such as corporate offices). This might necessitate creating copies of the original records and providing a location for storing them at the facility.
Keeping a record to provide confirmation that liquid is maintained above the solid uranium byproduct material or tailings present in non-conventional impoundments should also be relatively straightforward. This would involve visual inspection and documentation, such as written notes and digital photographs with embedded date and time and other identifying metadata, using photographic capabilities that are readily available, such as smartphones or small digital cameras. As noted earlier, NRC and Agreement State licenses require operators to inspect the facility on a daily basis. Only minimal effort will be necessary to make observations of saturation and record the information in inspection log books that are already kept on site and available to inspectors. Inspections for saturation can occur during the daily inspections that are already required by NRC and Agreement States. The final rule requires that operators record written observations daily and collect photographic evidence of liquid depth no less frequently than weekly. Beginning on the effective date of this final rule, digital photographs are to be uploaded on at least a monthly basis to the EPA's Subpart W Impoundment Photographic Reporting (SWIPR) system. If that system is unavailable, digital photographs are to be retained by the facility and provided to the EPA or the authorized state upon request.
The final rule also includes a definition of “final closure” that refers to notification by the facility owner/operator. Subpart W applies to operating sources used to manage uranium byproduct material or tailings. Sources cease to be operating when they enter the closure process. The definition of “final closure” in the final rule clarifies that closure does not begin until the owner or operator provides written notification to the EPA and the NRC that the impoundment or heap leach pile is no longer used for its operational purpose and is being managed under an approved reclamation plan for that impoundment or pile, or the facility closure plan. Such notifications should involve limited effort on the part of facility owners or operators. A reclamation plan is required by NRC regulation and is not a new requirement under Subpart W.
We estimate the burden in hours and cost for uranium recovery facilities to comply with the proposed recordkeeping and notification requirements are as follows:
1. What is the legal authority for GACT based standards and management practices in the final rule?
Section 112(q)(1) of the CAA requires that NESHAPs “in effect before the date of enactment of the Clean Air Act Amendments of 1990 [Nov. 15, 1990] . . . shall be reviewed and, if appropriate, revised, to comply with the requirements of subsection (d) of . . . section [112].” The EPA promulgated 40 CFR part 61, subpart W, “National Emission Standards for Radon Emissions from Operating Mill Tailings,” (“Subpart W”) on December 15, 1989.
Section 112(d) establishes the requirements for emission standards for HAP promulgated under section 112. It establishes different requirements for major sources and area sources. A major source is any stationary source that emits or has the potential to emit 10 tpy or more of any single HAP or 25 tpy or more of any combination of HAPs. An area source is a stationary source of HAP that is not a major source. See Sections II.B and IV.A.2 for discussion of area sources as they relate to Subpart W.
Pursuant to CAA section 112(d), standards for major sources “shall require the maximum degree of reduction in emissions of the hazardous air pollutants . . . that the Administrator . . . determines is achievable.” For area sources, the Administrator has the discretion under CAA section 112(d)(5) to set standards based on GACT in lieu of MACT. Specifically, CAA section 112(d)(5) provides that the Administrator may elect to promulgate standards or requirements for area sources “which provide for the use of generally available control technologies or management practices by such sources to reduce emissions of hazardous air pollutants.”
Section 112(q)(1) does not dictate how the EPA must conduct its review of those NESHAPs issued prior to 1990. Rather, it provides that the Agency must review, and if appropriate, revise the standards to comply with the requirements of section 112(d). Determining what revisions, if any, are appropriate for these NESHAPs is best assessed through a case-by-case consideration of each NESHAP. In other rulemakings, the EPA has determined that GACT standards are appropriate for
As explained below, in this case, we have reviewed Subpart W and are revising the standards consistent with section 112(d)(5), which addresses standards for area sources. After our review, we determined it was appropriate to revise Subpart W to clarify the applicability of the rule to non-conventional impoundments and heap leach piles and promulgate standards that are more appropriate for controlling radon emissions at those sources. All units regulated by Subpart W are area sources and we determined that promulgating GACT-based standards under CAA section 112(d)(5) is appropriate for these sources. Consistent with section 112(q)(1) we are revising Subpart W to comply with the requirements in section 112(d) relating to emission standards for area sources and are thus revising the Subpart W standards to reflect GACT-based standards.
We received several comments challenging our use of GACT for this rulemaking. Commenters specifically asserted that the EPA may not set GACT-based standards for sources subject to Subpart W and challenged our conclusion that facilities subject to Subpart W are area sources.
Commenters further argued that the work practices instituted for conventional impoundments in 1989, which we are finalizing today as GACT-based standards, are contrary to CAA section 112(h), which allows the EPA to promulgate work practices in lieu of MACT standards only when “it is not feasible in the judgment of the Administrator to prescribe or enforce an emission standard.”
We summarize below a number of comments received on this topic and present our responses. Additional comment responses on this topic appear in the Response to Comments document in the docket for this rulemaking.
In addition, regulating sources that manage uranium byproduct material or tailings as area sources does not constrain the EPA's regulatory options. For area sources, the EPA can set GACT standards under CAA section 112(d)(5) or MACT standards under CAA section 112(d)(2). EPA's decision to retain this flexibility by regulating these sources as area sources is reasonable and consistent with the discretion given to the EPA by the statutory text.
It is also worth noting that, under Subpart W, radon emissions from sources that manage uranium byproduct material or tailings are regulated regardless of whether they qualify as major or area sources. For source categories not regulated before 1990, the EPA has discretion to decide whether to list and thus whether to regulate area sources. Radon emissions from uranium byproduct material or tailings, however, were regulated prior to 1990 and CAA section 112(q) explicitly provides that such standards remain in force and effect after the effective date of the 1990 CAA Amendments. The distinction between major and area sources thus does not affect whether sources subject to Subpart W are regulated under CAA section 112. Nothing in CAA section 112(q)(1) or CAA section 112(d) limits EPA's discretion to set standards under CAA section 112(d)(5), for sources regulated prior to the 1990 CAA Amendments whose emissions do not exceed the major source threshold established by Congress.
Another commenter asserted that because CAA section 112(q) requires pre-1990 regulations to be reviewed and, if appropriate, revised in accordance with the requirements of subsection (d), the revision must comply with all applicable requirements in CAA section 112, including all parts of CAA section 112 enacted as part of the 1990 CAA Amendments.
One commenter also argued that the EPA must establish a source category or subcategory before promulgating standards under CAA section 112(d)(5) for facilities licensed to manage
The EPA disagrees with the commenters' assertions that the EPA must list the regulated source category pursuant to section 112(c) before revising the existing Subpart W. Section 112(q)(1), on its face, does not require the EPA to list such sources pursuant to subsection (c) as part of a section 112(q) review. It does not contain any cross reference to the listing provisions of section 112(c). Instead, section 112(q) requires revision, if appropriate, in accordance with subsection (d)—the subsection that governs standard setting under section 112. Moreover, section 112(c)(4) explicitly grants the Administrator discretion to decide whether or not to list categories and subcategories of sources regulated under section 112 prior to the 1990 CAA Amendments. Thus, neither of the provisions addressing standards promulgated prior to the 1990 CAA Amendments, nor any other statutory provision, support the commenters' assertion that listing under section 112(c) is a necessary part of a section 112(q) review.
There is also no basis for commenters' statements that the EPA must determine all HAPs present at uranium recovery facilities and develop criteria to differentiate between major and area sources of radionuclides before it can promulgate emission standards, whether MACT or GACT. The EPA's task under section 112(q) is to review and, if appropriate, revise standards in effect before the date of enactment of the 1990 CAA Amendments. Prior to the 1990 CAA Amendments, section 112 standards were promulgated for individual pollutants and Subpart W only establishes standards for radon resulting from management of uranium byproduct material or tailings at uranium recovery operations. The EPA's obligation under section 112(q) therefore is limited to reviewing and, if appropriate, revising standards for radon resulting from management of uranium byproduct material or tailings at uranium recovery operations. The statutorily required review does not encompass listing the source category under section 112(c) or evaluating HAPs not previously regulated under the subpart being reviewed. As explained in the previous response, the statute also does not require the EPA to set alternate criteria for distinguishing between major and area sources of radionuclides.
The commenter's reliance on a 2007 rulemaking is misplaced. In that rulemaking, the EPA promulgated NESHAPs for the first time for the identified source categories. The present rulemaking is governed by CAA section 112(q)(1), which only requires that the review and revision comply with the standard setting requirements of subsection (d). As explained above, the section 112(q)(1) review does not require listing the source category under section 112(c). The 2007 rulemaking set new standards and was not subject to the narrow review requirements of CAA section 112(q)(1). Further, CAA section 112(c)(4) explicitly provides the EPA with discretion regarding whether to list source categories regulated prior to the 1990 CAA Amendments. CAA section 112(c)(4) applies to the sources subject to Subpart W but was not applicable to the sources impacted by the 2007 rulemaking. For these reasons, the statements made in the 2007 rulemaking are inapposite.
The commenter's assertion that the EPA must revise Subpart W to comply with all provisions of section 112 is also based on an overly broad reading of CAA section 112(q)(1). The statute only instructs the EPA to “review[ ] and, if appropriate, revise[ ], to comply with the requirements of subsection (d) of this section . . .” It does not require the EPA to revise the pre-1990 rules to comply with every provision in the section 112 CAA Amendments of 1990. Indeed, to read section 112(q)(1) as requiring the EPA to revise the rules to comply with all provisions in section 112 would be to read the reference to subsection (d) out of the statute.
Finally, listing a source category under section 112(c) is not a pre-requisite to establishing GACT standards for area sources as part of a section 112(q) review. As explained in the previous response, section 112(d)(5) allows the EPA to set GACT instead of MACT standards for area sources. Specifically, CAA section 112(d)(5) provides that with respect only to categories and subcategories of area sources listed pursuant to section 112(c), the Administrator may, in lieu of setting standards under sections 112(d)(2) and 112(f), decide to promulgate standards based on generally available control technologies. Such standards are commonly referred to as GACT standards.
CAA section 112(d)(5) is ambiguous to the extent that it is not clear whether it provides that the EPA may set GACT standards “only” for “area sources” or whether it also prohibits the EPA from setting section 112(d)(5) GACT standards for area sources regulated under section 112 but not listed pursuant to section 112(c)—that is, area sources that are regulated pursuant to section 112 standards promulgated before the 1990 CAA Amendments but not added to the section 112(c) list. For the reasons explained below, the EPA does not interpret section 112(d)(5) as limiting its discretion to promulgate GACT standards as part of a section 112(q) review simply because the area source category has not been added to the section 112(c) list.
As an initial matter, the specific statutory provisions addressing section 112 standards that pre-dated the 1990 Amendments appear in sections 112(q)(1) and 112(c)(4). As discussed above, these provisions require the EPA to review and, if appropriate, revise such standards to comply with the requirements of subsection (d) and also establish that the EPA has discretion to decide whether or not to list source
The general standard setting obligation in section 112(d)(1) also provides helpful context. Specifically, CAA section 112(d)(1) states that “The Administrator shall promulgate regulations establishing emission standards for each category or subcategory of major sources and area sources of hazardous air pollutants listed for regulation pursuant to subsection (c) of this section . . .” Section 112(d)(1) grants the EPA authority to set emission standards under both section 112(d)(2) (MACT standards) and section 112(d)(5) (GACT standards). Like section 112(d)(5), it cross references the listing provision of subsection (c). Neither provision explicitly addresses how it applies in the context of a section 112(q) review. And neither provision explicitly overrides either the section 112(q) review requirements or the discretion granted to the Administrator under section 112(c)(4). Therefore, for standards promulgated prior to the 1990 CAA Amendments, it is reasonable for the EPA to interpret sections 112(d)(1) and (d)(5) to not require listing pursuant to § 112(c) before the EPA can review the standards under section 112(q)(1) and, if appropriate, revise them to comply with subsection (d). In contrast, if the EPA were to take the approach suggested by commenters, and read the cross references to subsection (c) in sections 112(d)(1) and 112(d)(5) as a limitation on the EPA's authority under section 112(q) to revise standards to comply with subsection (d) it would be inconsistent with CAA sections 112(q)(1) and 112(c)(4).
Given the statutory context outlined above, for this CAA section 112(q)(1) review, it is reasonable for the EPA to interpret CAA section 112(d)(5) as restricting the EPA's ability to set GACT standards to “only area sources,” but not prohibiting the EPA from setting GACT standards as part of a section 112(q) review simply because the area source category is not listed pursuant to subsection (c).
One of these commenters stated that the EPA has no legal basis for the promulgation of a design, equipment, work practice, or operational standard, or combination thereof, in lieu of a radon emission standard, because design, equipment, work practice, or operational standards are meant to supplement, not replace, a standard that places specific numerical limitations on HAP emissions. The commenter also asserts that the EPA has no legal basis for eliminating the emission standard for existing mill tailings impoundments.
The other commenter pointed to text from the legislative history of the 1990 CAA Amendments and stated that work practice standards must achieve the same or greater level of emissions reduction as a numerical emission standard. The commenter argues that radon emissions will be higher under the GACT standards than they would be under a numerical emission standard and therefore the EPA should promulgate an emission standard.
Instead, CAA section 112(d)(5) provides the EPA with discretion regarding the type of standards it sets for area sources by permitting the EPA to set standards or requirements “which provide for the use of generally available control technologies or management practices” (42 U.S.C. 7412(d)(5)). The EPA determined that the management practices required in this final rule constitute generally available management practices and effectively control radon emissions from conventional impoundments constructed after December 15, 1989, non-conventional impoundments and heap leach piles.
Because CAA section 112(d)(5) provides the EPA with the option of establishing management practices, the EPA was not required to make a showing under CAA section 112(h) that an emissions standard is not feasible before we set management practices. Further, CAA section 112 does not provide that management practices must supplement emission standards; the EPA may set management practices to control emissions pursuant to CAA section 112(d)(5).
With respect to existing conventional impoundments in existence on December 15, 1989, the EPA is retaining the emissions standard originally promulgated in 1989. During the comment period, the EPA learned that the information on which it relied when proposing to remove the emission standard requirement for existing conventional impoundments designed or constructed prior to December 15, 1989 was not accurate. Because the conventional impoundments in existence on December 15, 1989 are constructed in such a way that they are unable to comply with the standards being promulgated for conventional impoundments constructed after December 15, 1989, the EPA determined that it is appropriate to retain the emissions standard and monitoring requirement for conventional impoundments in existence on December 15, 1989. Because these units have been subject to a radon flux standard of 20 pCi/m
The EPA evaluated all types of units regulated by Subpart W: Conventional impoundments in existence as of December 15, 1989, conventional impoundments constructed after December 15, 1989, non-conventional impoundments, and heap leach piles. Each type of unit has different characteristics. Also, not all units were subject to the same requirements at the time of their construction, and the feasibility of compliance with emissions standards and/or management practices also varies between types of units. The EPA took these variations into consideration when we conducted our GACT analysis for each type of unit. Because the three remaining conventional impoundments in existence as of December 15, 1989 were subject to different construction requirements than units constructed after that date, and are not amenable to the management practices established in 1989 for those newer units, different standards are appropriate.
The legislative history language referenced by the commenter is concerned with the stringency of work practice standards promulgated under CAA section 112(h), when an emissions standard is not feasible. This passage of the legislative history is not discussing
This commenter similarly argues that the EPA has no legal or regulatory bases to apply Subpart W to evaporation ponds at uranium recovery facilities. Further, the commenter states that after 20 years of consistent interpretation that Subpart W is only applicable to uranium mill tailings impoundments, the EPA is now asserting that Subpart W applies to evaporation ponds at in-situ recovery and conventional mill tailings facilities. The commenter argues that the EPA's position is inconsistent with the language and the rulemaking history associated with Subpart W since the regulations discuss uranium mill tailings “piles” and the rulemaking record states that the radon cover requirements in Subpart W's work practice standards are not intended to apply to such fluid retention impoundments.
The commenter also challenges that evaporation ponds are not covered by Subpart W because the specific examples in the regulations do not include evaporation ponds.
Another commenter argues that the liquid impoundments should not be regulated as tailings impoundments and should not be subject to 40 CFR part 192.
Alternatively, one commenter supported the EPA's confirmation that ISL facilities and liquid impoundments are subject to the EPA's CAA NESHAP jurisdiction. The commenter also stated that where the rule does not include emissions limits confirmed by monitoring and reporting requirements, the EPA has not carried out its CAA duty to minimize or eliminate radon emissions.
Commenters' arguments that the EPA lacks authority to regulate non-conventional impoundments lack merit. As an initial matter, commenters do not and could not support their assertion that the EPA lacks legal authority to regulate these impoundments. Radionuclides, including radon, are listed as HAPs in CAA section 112(b)(1), and the EPA has authority under sections 112(d) and 112(q) to regulate radionuclide emissions from sources that manage uranium byproduct materials or tailings.
In addition, commenters' alternate arguments, that these impoundments are not currently and should not be regulated by Subpart W, are incorrect. As promulgated in 1989, Subpart W requirements specifically apply to the structures at the uranium recovery facilities that are used to manage or contain the uranium byproduct material or tailings during and following the processing of uranium ores. 40 CFR 61.250. Common names for these structures may include, but are not limited to, impoundments, tailings impoundments, evaporation or holding ponds, and heap leach piles. However, the name itself is not important for determining whether Subpart W requirements apply to that structure; rather, applicability is based on what these structures contain. Uranium byproduct material or tailings produced by ISL is covered by the definition of uranium byproduct material or tailings included in the 1989 Subpart W NESHAP, which is not altered by this final rule.
The EPA understood that there was previously some confusion regarding the applicability of Subpart W to different units that manage uranium byproduct material or tailings, including impoundments and evaporation ponds at ISL facilities (non-conventional impoundments) and heap leach facilities. The EPA also acknowledges that the provisions of the 1989 rule applied imperfectly to these units. The industry is shifting toward ISL as the dominant method of uranium recovery and, while it is not expected to be as significant a source of radon emissions as conventional impoundments, it is reasonable for the EPA, as part of this section 112(q) review, to clarify that the standards in Subpart W apply to non-conventional impoundments. To eliminate any potential confusion, the final rule reaffirms that Subpart W continues to regulate radon emissions from all management of uranium byproduct material or tailings at uranium recovery facilities. Subpart W has always applied to these units; this final rule clarifies that applicability and confirms that these impoundments are covered by Subpart W by establishing management practices tailored to non-conventional impoundments.
The EPA has authority to interpret its own regulations,
Commenters incorrectly state that evaporation ponds are not covered by Subpart W because evaporation ponds are not used as an example in the regulation. Similarly, commenters' claims that the radon cover requirements are not intended to apply
In addition, to the extent commenters are challenging the EPA's interpretation of the applicability provisions in 40 CFR part 192, such comments are beyond the scope of this rulemaking and the EPA has no obligation to respond. This rulemaking addresses only Subpart W. The EPA's May 2, 2014 proposal did not reopen or take comment on any aspects of part 192. The applicability provisions of part 192 appear at 40 CFR 192.00. Subpart W does not expand the scope of applicability of part 192 as liners meeting the requirements at 40 CFR 192.32(a)(1) are already mandated by other regulations (79 FR 25407).
In response to one commenter's argument that Subpart W should not regulate evaporation ponds at ISL facilities because of the amount of water present in the ponds, the EPA disagrees. While the EPA agrees that the presence of sufficient liquid significantly reduces the radon emissions, that is not itself a reason to exclude evaporation ponds from regulation as a pond may still contain uranium byproduct material or tailings, which have the potential to emit radon. As stated above, the presence of uranium byproduct material or tailings in the pond determines whether the pond is regulated by Subpart W. The management practices the EPA is promulgating in Subpart W ensure that the radon emissions are continuously effectively controlled. The EPA requires that owners and operators of non-conventional impoundments ensure that the uranium byproduct material or tailings remains saturated, meaning that the material is covered in liquid, which will effectively control radon emissions from these impoundments.
The EPA acknowledges and appreciates the commenter's support of the EPA's clarification that uranium in-situ leach facilities are subject to Subpart W. The EPA's response to the comment regarding the requirement to establish emissions limits confirmed by monitoring and reporting requirements is contained in the response to the previous comment.
Both commenters asserted that if the NRC believed that the imposition of the part 192 requirements were justified, the NRC would have explicitly referenced 40 CFR 192.32(a)(1) and by extension 40 CFR 264.221 in 10 CFR part 40 Appendix A, but it does not.
Alternatively, another commenter asserted that the EPA cannot allow a situation where the reduction of radon emissions comes at the expense of increased pollution of the groundwater or surface water. The commenter is concerned that the rule works at cross-purpose with 40 CFR part 192.
Subpart W does not regulate groundwater or establish groundwater protection standards. Groundwater contamination is controlled by pre-existing regulations prepared under the Uranium Mill Tailings Radiation Control Act of 1978 (UMTRCA). During Subpart W rule development, the EPA considered the other regulations that impact sources subject to Subpart W and understood that surface impoundments subject to Subpart W are also subject to the standards in 40 CFR part 192 and part 264, subpart K. The part 192 groundwater protection regulations and liner requirements independently apply to the units subject to Subpart W. Through part 192 and part 264, subpart K, requirements were already in place at the time Subpart W was originally promulgated to protect groundwater from sources that manage uranium byproduct material or tailings. As the EPA explained in 1986, “potential effects of various alternatives on ground water were considered as part of the analysis of the impacts of this rule, since EPA has a responsibility to consider the impacts that its rules may have on the total environment. In part, this is done to ensure that regulations do not control pollution in one environmental medium only to degrade another” (51 FR 34058-34059). See also 54 FR 51680.
The EPA has considered the potential effects on groundwater from industry practices under this rule. The EPA also considered the separate, already existent, groundwater protection requirements when initially developing Subpart W. The EPA recognized that if water cover is maintained or expanded in order to limit radon emissions to the atmosphere, the potential for impacting groundwater increases because of the greater hydraulic head. It thus reasonably considered the extent to which existing requirements would limit potential groundwater impacts in determining reasonable management practices to limit radon emissions to the ambient air.
Additionally, the liner requirements have a direct connection to the effectiveness of Subpart W in limiting radon emissions from uranium byproduct material or tailings. It is well established that moisture reduces the rate of radon emanation. An unlined or poorly lined impoundment is more likely to lose moisture through the bottom of the impoundment. This not only increases the potential for ground water contamination, but increases the potential for the uranium byproduct material or tailings in the impoundment to dry out, thereby increasing radon emissions. Thus, the liner requirements
Comments on the NRC regulations contained in 10 CFR part 40 Appendix A are beyond the scope of this rulemaking and, in any event, the regulations in 10 CFR part 40 Appendix A speak for themselves. In 10 CFR part 40 Appendix A, the NRC references and recognizes that the standards promulgated by EPA in 40 CFR part 192 achieve the minimum level of stabilization and containment of the sites concerned and a level of protection for public health, safety, and the environment from radiological and nonradiological hazards associated with the sites. Additionally, 10 CFR part 40 Appendix A incorporates the basic groundwater protection standards imposed by the EPA in 40 CFR part 192 which apply during operations and prior to the end of closure. 10 CFR part 40 Appendix A requires groundwater monitoring to comply with these standards.
In response to the other commenter, the EPA considered the regulations that independently apply to sources subject to Subpart W. The EPA recognized that the scope of units required to operate with liners pursuant to part 192 is consistent with the Subpart W regulations. Subpart W does not lessen the effectiveness of part 192.
The commenters also advocated for the EPA expanding the scope of operations covered by Subpart W at heap leach facilities. Specifically, the commenters encouraged the EPA to regulate radon emissions from the time ore is placed on the pile, to the placement of a final radon barrier, including periods of standby, and time periods prior to and during the placement of lixiviant on a heap leach pile. The commenters also took the position that heap leach piles that are drying out should be subject to a radon emission standard.
When the EPA initially promulgated Subpart W in 1986, we identified radon as the radionuclide released to air that presented the highest risk at uranium recovery facilities and determined that units managing uranium byproduct material or tailings were the most significant source of radon emissions (51 FR 34056). Since 1986 and re-promulgation in 1989, Subpart W has only regulated units that manage uranium byproduct material or tailings at uranium recovery facilities (40 CFR 61.250). Other potential emission points in these facilities were not previously the subject of Subpart W regulation and were not assessed for the 1989 rulemaking. The EPA's CAA section 112(q) review of Subpart W was limited to the existing standard. Because Subpart W did not regulate other potential emission points, the EPA did not include any other potential emission points in its CAA section 112(q) review. In this final rule, the EPA continues to regulate the management of uranium byproduct material or tailings from conventional mills, from ISL facilities and from heap leach piles.
With respect to regulation of heap leach piles, the EPA similarly retained the scope of Subpart W's applicability to sources that manage uranium byproduct material or tailings from heap leach operations. The EPA determined that, for purposes of Subpart W, while lixiviant is being sprayed on heap leach piles, the piles are part of the milling process rather than an impoundment whose function is to manage uranium byproduct material or tailings. The final rule does, however, cover the other impoundments used to manage the uranium byproduct material or tailings associated with the heap leaching operation and covers the heap leach pile during the period between the conclusion of processing and the day that final closure begins. See Section IV.D.
One commenter takes the position that the EPA does not have authority to define when uranium recovery facilities are considered to be “active” or involved in “operations.” Instead, the commenter states that the NRC, not the EPA, has authority over decommissioning and decontamination of AEA-licensed source material recovery facilities, including the mill itself, site soil cleanup, final tailings stabilization, and groundwater restoration or corrective action. Further, the commenter states it is inefficient for uranium recovery operations to obtain two separate authorizations with essentially the same requirements for radon risk from fluid retention impoundments (
Another commenter states the Department of Energy also has authority to regulate this industry.
Alternatively, some commenters supported the EPA's authority under the CAA to regulate HAPs, particularly radon, from uranium processing and do not believe that the CAA limits the EPA's regulatory authority with respect to 11e.(2) byproduct material
One commenter also thinks that the EPA does not have statutory authority to define tailings as restoration fluid because that authority rests exclusively with the NRC.
Regarding the question of restoration fluids, we note that the designation of restoration fluids as “waste produced by the extraction or concentration of uranium from any ore processed primarily for its source material content” is consistent with the approach taken by the NRC. See Staff Requirements Memorandum—SECY-99-013, “Recommendation on Ways to Improve the Efficiency of NRC Regulation at
Numerous commenters supported the EPA's decision to regulate radon emissions from uranium mill facilities. Specifically, two commenters state that the EPA has authority to regulate all radon at mills and another commenter confirmed that the EPA has a role in regulating uranium mill tailings. A third commenter stated that the EPA has authority to conduct radon flux measurements.
After reviewing stakeholder comments and verifying the information provided in them, we are not eliminating the radon flux standard of 20 pCi/m
During the comment period we received information that led us to conclude that we had erred in stating an equivalency between the two types of impoundments. We originally stated that the Sweetwater and Shootaring impoundments had a double liner system equivalent to the impoundments designed after December 15, 1989. We were incorrect. Commenters
Some commenters also supported requiring compliance with the flux standard for all impoundments, including those not now subject to it, but we have concluded that to be unnecessary if the owner/operator of an impoundment follows the design and other management practices outlined in the GACT-based standard because these measures are expected to effectively control total radon emissions.
As described in the preamble to the proposed rule, we updated the risk analysis we performed when we promulgated Subpart W in 1989 (79 FR 25395, May 2, 2014). We performed a comparison between the 1989 risk assessment and current risk assessment approaches, focusing on the adequacy and the appropriateness of the original assessments.
Because we proposed to establish GACT-based standards to limit radon emissions from the management of uranium byproduct material or tailings at uranium recovery facilities, thereby eliminating any emissions standards and monitoring requirements, it was not necessary for us to update the risk assessment. GACT is not determined on the basis of risk. We conducted the analysis to inform ourselves regarding the continued protectiveness of the radon flux standard as we considered whether the proposed GACT approach could be extended to impoundments in existence on December 15, 1989. We concluded that, even using updated risk analysis procedures (
The updated risk assessment involved evaluating exposures to off-site (maximally exposed) individuals and populations from reported total site radon emissions at a number of uranium recovery facilities. In doing so, we found that the risks to individuals and populations were comparable to or lower than those estimated in the 1989 rulemaking. The updated risk assessment employed the most recent risk factors for radon inhalation, which are age-averaged to incorporate the sensitivity of children to radiation. The factors used in the 1989 risk assessment were based on exposures to adults.
This final rule retains the flux standard for conventional impoundments in existence on December 15, 1989. The updated risk assessment and our conclusion that the radon flux standard continues to be protective support our decision to retain the flux standard in the rule. The updated risk assessment is included in the Background Information Document (BID) for the final rule.
In developing the risk assessment and BID, we also conducted environmental justice analyses for the immediate areas (
We received comments stating that the monitoring requirements for impoundments in existence on December 15, 1989 should be retained and that our proposal was based on faulty information. We also received comments recommending that monitoring be extended to all impoundments. Some commenters supported lowering the flux standard.
We proposed to designate the management practices promulgated in the 1989 rulemaking for impoundments constructed after December 15, 1989 as GACT-based standards for all conventional impoundments. In doing so, we evaluated the reasoning used in the 1986 and 1989 Subpart W rulemakings to determine that the phased disposal and continuous disposal management practices protect public health with an ample margin of safety (54 FR 51681).
We initially defined these two management practices because they provided a means for newly-designed impoundments to limit radon emissions, either by limiting the overall size of the impoundment or by limiting the area of dried (dewatered) uranium byproduct material or tailings that can be exposed at any time. We found the two management practices to improve performance (risk to exposed individuals and population) by approximately 35% to more than 50%, respectively, compared to earlier practices of constructing larger impoundments without limiting their number or the exposed area. The potential for larger impoundments or many smaller impoundments to remain uncovered and their radon emissions uncontrolled if bankruptcy prevented proper closure was considered to provide a further advantage to the two management practices (54 FR 51680).
Owners and operators of uranium recovery facilities in the United States have all used the phased disposal method for management of uranium byproduct material or tailings in conventional impoundments, making it a generally available management practice to control radon emissions. We have found no reason to believe that this method is unworkable, unreasonably burdensome or ineffective in limiting radon emissions. Keeping the uranium byproduct material or tailings wet or partially covered, as is typical practice, further reduces radon emissions. These industry practices also clearly demonstrate that the phased disposal method is a generally available technology. In addition, while there has been no use of the continuous disposal method in the United States, it has been successfully employed in other countries, and was proposed for use by some U.S. companies in the 1980s. Therefore, this final rule designates the phased disposal and continuous disposal methods as elements of GACT-based standards for conventional impoundments constructed after December 15, 1989. Because these impoundments are separately required to comply with the requirements at 40 CFR 192.32(a)(1), we concluded that such a management practice is generally available and contributes to the control of radon emissions as described more fully in Section IV.A.2. Conventional impoundments must also comply with the construction requirements in 40 CFR 192.32(a)(1).
We received some comments questioning the effectiveness of the 1989 management practices and our decision to adopt those practices as GACT-based standards. These commenters argued that there is no basis for concluding that these practices are effective in limiting radon emissions when no confirmatory monitoring has been done. They further
Commenters also asserted that we have not sufficiently examined other technologies employed either in other countries or in related industries. One commenter argues that other technologies (
Regarding the area limitation, we disagree with the commenters. The focus of the 1989 analysis was on limiting the surface area from which radon would be emitted.
We proposed to regulate the heap leach pile from the moment that uranium begins leaching from the ore pile. This approach was based on the view that uranium byproduct material or tailings is produced the moment the lixiviant passes through on its first pass and uranium begins to be leached from the ore (79 FR 25403). At the point of uranium movement out of the heap, what remains is uranium byproduct material or tailings as defined by 40 CFR 61.251(g). In other words, what remains in the heap is the waste produced by the extraction or concentration of uranium from ore processed primarily for its source material content. The heap leach pile manages that uranium byproduct material or tailings, even as the pile is further leached to extract uranium. The proposal placed the emphasis on the presence of uranium byproduct material or tailings in the heap leach pile.
We also requested comment on an alternative approach we described in the proposal (79 FR 25398). Under this approach, heap leach piles would not fall under Subpart W until after leaching is permanently discontinued. This approach is based on the view that, as long as the heap is being leached, the ore on the heap leach pad is being processed. While uranium byproduct material or tailings may
Many commenters (primarily those from industry) supported basing the
Although we proposed to bring the heap under the jurisdiction of Subpart W based upon the presence of uranium byproduct material or tailings within the pile, after further consideration we find the commenters' reasoning compelling and more consistent with previous application of the rule. Subpart W has historically not regulated radon emissions from the milling or extraction process, even at the intermediate points where residuals from uranium extraction make up the bulk of the material being processed, which may be the situation as processing of the heap progresses. Subpart W has regulated only the disposition of the wastes at the end of the separations process. Consistent with this precedent, the heap leach pile is like a conventional impoundment and will be subject to Subpart W once uranium extraction is complete and only uranium byproduct material or tailings remains. Until that time, the heap is considered to be either an unprocessed ore pile or a uranium recovery facility. Thus, heap leach piles are regulated by Subpart W only during the period between the end of processing (
There is a significant aspect of heap leach pile management that is important to these regulations. Several commenters from industry stated that a heap leach pile, unlike a conventional impoundment, will immediately begin closure after processing has concluded (either closure in place, or possibly removal for placement in a conventional tailings impoundment). If that is the case, there will be no period when the heap is subject to the requirements of Subpart W. Because there are no heap leach facilities operating in the United States, we have no basis for disputing these statements of industry's intent. Nevertheless, we have concerns that these good intentions may prove insufficient to ensure that closure takes place as expeditiously as the commenters believe. There is some potential that heap leach piles will complete processing but not immediately enter closure. During such a period the owner or operator is only using the pile to manage uranium byproduct material or tailings, and the heap leach pile is then subject to the requirements of Subpart W. The specification in the final rule that final closure does not begin until the operator has provided a written notification to the EPA and the NRC will minimize the potential for confusion regarding the applicability of Subpart W. A further concern might be that operators continue “processing” the pile indefinitely, thereby postponing the costs associated with closure. This would be a matter for the NRC or NRC Agreement States to consider.
We recognize that heap leach piles will emit radon while they are being processed. However, as explained above, Subpart W has traditionally been applied to uranium byproduct material or tailings after exiting the extraction process. Thus, Subpart W has not been applied to other sources of radon at uranium recovery facilities where wastes are present, such as material in thickeners or other processing units. The NRC, or NRC Agreement State, regulates the radionuclide emissions from all sources at a uranium recovery facility. The operator is required to report particulate radionuclide and Rn-222 concentrations at the facility boundary. Thus, radon emissions from sources not covered under Subpart W, including those from the raw ore in heap leach piles or processed yellowcake, are captured by the NRC reporting requirements. However, we emphasize that the best way to control radon emissions from heap leach piles after they have completed processing is to expeditiously close them and install a permanent radon barrier.
As described in the preceding section, after reviewing comments, we have decided to require that heap leach piles conform to the standards for other uranium recovery facility impoundments only during the period between processing (
Since heap leach piles are in many ways similar to the design of conventional impoundments, the same combination of phased disposal management practices (limitation to no more than two heap leach piles that are no longer being processed but have not yet entered closure, each one no more than 40 acres in area) that limit radon emissions from conventional impoundments will also limit radon emissions from heap leach piles. Because this management practice is generally available for conventional impoundments, heap leach piles can control radon emissions through the same practice. We determined that phased disposal is a GACT-based management practice that will effectively limit radon emissions from these units. Use of the phased disposal management practice will limit the amount of exposed uranium byproduct material or tailings that can emit radon. Because these units will be separately required to comply with the requirements at 40 CFR 192.32(a)(1), we concluded that such a management practice is generally available and contributes to the control of radon emissions as described more fully in Section IV.A.2.
The third issue we are addressing is the proposed requirement for heap leach piles to maintain a 30% moisture content. In the proposal we recognized that owners and operators of conventional impoundments also limit the amount of radon emitted by keeping the uranium byproduct material or tailings in the impoundments covered, either with soil or liquids (79 FR 25398). At the same time, we recognized that keeping the uranium byproduct material or tailings in the heap in a saturated or near-saturated state (in order to reduce radon emissions) is not a similarly practical solution. In the definitions at 40 CFR 61.251(c) we have defined “dewatered” tailings as those where the water content of the tailings does not
After considering stakeholder comments and information, we conclude that it is physically impossible to maintain a 30% moisture content within the heap leach pile and have it remain stable.
Comments submitted on heap leach piles focused on the proposed approach to regulation and the proposed requirement to maintain a 30% moisture content.
Further, several of these commenters stated that heap leach piles will immediately enter into closure upon the cessation of processing, so there is no period when they are “operating” simply as uranium byproduct material or tailings management units. As a result, they see no time at which Subpart W can apply to heap leach piles.
Some commenters raised the distinction between “close in place” piles and “on-off” piles. Commenters explain that the latter operations involve the removal of the processed heap and placement in a conventional impoundment. In this case, the commenters agree that the uranium byproduct material or tailings from the heap, and the impoundment into which it is placed, would be subject to Subpart W.
We appreciate the commenter's description of the “on-off” heap leach piles and agree that if a processed heap is removed and placed in a conventional impoundment, that impoundment is subject to Subpart W.
We emphasize the importance of closing piles “as expeditiously as practicable considering technological feasibility” once processing concludes. Industry commenters provided assurances that there would be no untoward delay in beginning the closure process. We encourage NRC to ensure that this is the case. Closure is a more comprehensive system to assure that emissions are minimized for the long term. Once processing has ended, the heap leach pile serves only as a uranium byproduct material or tailings management structure. Such a pile will be subject to Subpart W if the operator has not informed regulators that it is being managed under an approved reclamation plan. As set forth in the final rule, in such a situation, the phased disposal restrictions will apply (no more than two such piles at any time, with area no greater than 40 acres each). Heap leach piles subject to Subpart W must also comply with the construction requirements at 40 CFR 192.32(a)(1). Timely closure of heap leach piles will be better for public health than maintaining piles in an interim state in which they fall under Subpart W.
The purpose of non-conventional impoundments, also known as evaporation or holding ponds, is to manage liquids generated during and after uranium processing operations. We proposed to require one meter of liquid to remain in the impoundment at all times (79 FR 25411). The liquid cover was proposed as a management practice that would limit radon emissions from the uranium byproduct material or tailings.
The Subpart W regulation as promulgated in 1989 did not clearly distinguish between conventional tailings impoundments and those operating as ponds (
For non-conventional impoundments, the proposed rule allowed for an unlimited number of units to be operating, with no size limitation, but required that a depth of one meter of liquid be kept above any precipitated solids (uranium byproduct material or tailings). The use of the word “liquid” is important here. Typically, operators divert process water to evaporation or holding ponds, where it may be recycled, treated, evaporated, or disposed by injection. Thus, it is likely that the liquid entering the impoundment will contain uranium byproduct material or tailings in solution or suspension. Some portion of this uranium byproduct material or tailings will settle out into sediments. In our proposal we did not specify that the one meter of liquid covering a non-conventional impoundment be fresh water; however, we did refer to “water” in the preamble, and the comments demonstrate that there has been some confusion about this point.
Various commenters described the cost of locating fresh water in the semi-arid and arid western portions of the United States in order to meet the one meter requirement. Other comments focused on the limitations in operational flexibility that a fresh water cover would create by changing the chemistry of a stream that is often recycled back into the extraction process, or noted that this requirement would require re-design of impoundments.
We recognize that this requirement could result in the need to use large volumes of water that may not be readily available in the arid to semi-arid areas in which most uranium recovery facilities operate. Even for facilities that maintain large volumes of process water in ponds, there would likely be some demand for fresh water as a supplement to maintain the required liquid level. Further, maintaining this level of liquid cover would result in placing significantly more hydraulic head on the liner systems for the impoundments, which is counter to existing state and federal regulations and guidelines for operating these systems, as well as a concern to the Agency that the liner would be more susceptible to failure.
In light of these comments, we took a closer look at the proposed requirement. The best indicator of potential Rn-222 emissions during the impoundment's operating period is the concentration of Ra-226 in the liquid and sediment. The BID to support the 1989 rulemaking indicates that the Ra-226 concentrations in conventional uranium byproduct material or tailings is as much as an order of magnitude higher than evaporation pond sediments at the same uranium recovery facility (1989 BID Volume 2, Risk Assessments, EPA/520/1-89-006-1, Table 9-2, Docket No. EPA-HQ-OAR-2008-0218). We have recognized that keeping uranium byproduct material or tailings in conventional impoundments wet helps to limit radon emissions. Moreover, this management practice is used throughout the industry, even in arid regions, and can thus be considered “generally available.” We have further recognized that the difference between uranium byproduct material or tailings that are saturated and those covered with one meter of liquid is negligible (79 FR 25398). Therefore, the final rule's requirement that solids remain saturated achieves the same goal as the proposed standard of maintaining a one-meter liquid cover.
Commenters also expressed concern over Rn-222 emissions resulting from Ra-226 dissolved in the liquid present in non-conventional impoundments, as opposed to solid materials in the bottom of the impoundment. A number of commenters questioned our conclusion that radon emissions from uranium byproduct material or tailings in non-conventional impoundments could be greatly reduced by keeping the solids saturated, and reduced to nearly zero by maintaining a liquid cover. The BID shows in Figure 12 that 100% saturated soil reduces radon emanation by nearly 95% compared to dry material, while one meter of liquid provides a further reduction of about 93%, or an overall reduction of greater than 99% (BID Equation 5.1).
We carefully evaluated the data and emissions analyses submitted by commenters. We determined that the data cited by the commenters did not support their conclusions. We conclude that our analysis in the proposal was correct regarding the characteristics of non-conventional impoundments and the radon attenuation that could be achieved. See Section IV.E.2 for more detail on this issue.
To summarize, we received comments that raise concerns regarding the economic and technical feasibility, as well as the practical effect, of specifying a liquid level for non-conventional impoundments. We further confirmed that keeping the sediments in a non-conventional impoundment at 100% saturation is nearly as effective as maintaining one meter of water (liquid) cover (Figure 12 in the BID for the final rule). The cost and logistics of maintaining a one-meter liquid cover in arid regions also favor maintaining saturation, especially given that saturation effectively controls emissions and will limit economic impacts.
We evaluated management practices in use at non-conventional impoundments in the industry that could achieve the goal of limiting radon-222 emissions from these units. These units are designed to hold liquid, and typically any uranium byproduct material or tailings contained in these impoundments is covered by liquid. Maintaining a liquid cover over the uranium byproduct material or tailings would effectively control radon and is a practice that is generally available to owners and operators of non-conventional impoundments. Therefore, we have revised the proposed rule language to indicate that the solids in a non-conventional impoundment must remain saturated at all times. In this final rule, we are establishing this condition, along with the liner requirements in 40 CFR 192.32(a)(1), as GACT-based standards for non-conventional impoundments. As noted above, this will reduce radon emissions by approximately 95% compared to dry conditions. We recognize that operators may still have to add water at times to ensure that the uranium byproduct material or tailings remain saturated, particularly during standby or high-evaporation periods. However, we anticipate that the need for additional water will be much less than would be necessary to maintain one meter of liquid. Because these impoundments are separately required to comply with the requirements at 40 CFR 192.32(a)(1), we concluded that such a management practice is generally available and contributes to the control of radon emissions as described more fully in Section IV.A.2.
The final rule requires that visual evidence of saturation must be recorded and maintained by the owner/operator of the non-conventional impoundment, which we anticipate can be obtained using a smartphone or a digital camera during the routine daily inspections required by NRC regulations. Written observations must be recorded daily, with digital photographs to be taken at least weekly. Photographs including embedded metadata must be uploaded to the Subpart W Impoundment Photographic Reporting (SWIPR) Web site maintained by the EPA on at least a monthly basis, beginning on the effective date of this final rule.
We received a variety of comments related to non-conventional impoundments. Many were related to the proposed requirement to maintain one meter of liquid in the impoundment. Others related to the potential for radon emissions from liquids in the impoundments, and whether those risks were properly characterized.
Some commenters questioned the need for this requirement, and noted statements in previous rulemakings that the difference between saturation and one meter of water is negligible. Commenters further argued that non-conventional impoundments present a small risk in any case. A few commenters suggested that a better approach would be to require that solid materials in the impoundment remain saturated, with no solids visible above the liquid level.
The 2015 annual wastewater sampling report for White Mesa
The Ra-226 concentrations found in 2015 are consistent with historical data, also included in the sampling reports. For the period 1980-2003, the maximum concentration of Ra-226 recorded is 1,690 pCi/L, based on sampling from Cell 1, Cell 2, and Cell 3 (it is not specified which cell recorded the maximum concentration). Table 6 of the Task 5 report estimates that, based upon site-specific conditions at the White Mesa Mill, a Ra-226 concentration of 1,000 pCi/L in impoundment liquids would result in a radon flux of approximately 7 pCi/m
These results are also consistent with information reported for liquid impoundments at ISL facilities (see Tables 7, 8 and 9 of the Task 5 report). They also suggest that the noteworthy fluctuations in recent years may not be directly attributable to the radium content of the liquids, but may result from the analytical method used. “Total” or “gross” analytical methods are generally considered screening tools whose results are more susceptible to other influences. Energy Fuels states that the individual isotopic analyses “show that the increasing gross alpha results are being caused by matrix interference due to the nature of the tailings solution and are not representative of gross alpha from radium concentrations in the solution” (Energy Fuels, 2015 annual wastewater sampling report, page 15). Similar fluctuations occurred for all the impoundments (although, as noted earlier, Cell 3 showed a significant increase in 2013, with a decrease in 2014).
As an additional source of information, the facility's 2015 “Semi-Annual Effluent Monitoring Report” (July through December) provides radon monitoring data from air monitoring stations posted around the impoundments. The facility resumed monitoring for radon in 2013 and the data presented in Attachment J of the report show that emissions have been within the limits calculated to correspond to a 25 mrem annual dose for continuous exposure at each monitoring station. These limits serve as As Low As Reasonably Achievable (ALARA) goals for the facility.
In most cases, results are well below that level. The highest annual result (four consecutive quarters) can be seen for Station BHV-4, which is located directly south of the impoundments but still within the White Mesa facility boundary. A person located at this point during 2015 would have incurred a dose of approximately 16 mrem
Both the sampling data from the non-conventional impoundment cells and the radon data from the air monitoring stations at the White Mesa Mill support the EPA's conclusion that emissions from the liquids in non-conventional impoundments represent a limited source of radon and does not support commenters' argument to the contrary.
Subpart W also does not apply to impoundments constructed for the purpose of managing liquids generated by closure or remediation activities, when they are used solely for that purpose. Impoundments that do not contain uranium byproduct material or tailings resulting directly from uranium recovery operations are not considered to be non-conventional impoundments as defined in Subpart W.
However, non-conventional impoundments remain subject to the requirements of Subpart W until they enter final closure pursuant to an approved reclamation plan for that impoundment, even if at some point in their operational life they are used for the purpose of managing liquids from closure or remediation activities. EPA recognizes that non-conventional impoundments that are subject to
Operationally, this should not represent a burden to licensees. If the impoundment is being used to manage liquids from closure or remediation activities, it should remain in compliance with the requirement to retain sufficient liquid to cover solid materials in the impoundment. Further, because there is no restriction on the number of such impoundments that may be operating at one time, the licensee will not face the same pressure to begin closure as applies to conventional impoundments using the phased disposal approach.
While radium contained in the liquid will contribute to radon emissions, those emissions will be attenuated to some degree by the liquid in which it is contained. Further, liquid on top of solid materials will effectively limit radon emissions from those solids reaching the air, even if the liquid itself contains radium. While higher concentrations of radium in the liquid will generate more radon, concentrations in non-conventional impoundments have not been seen to reach levels of concern. See the response to the earlier comment in this section.
We proposed a relatively minor change to the definition of “operation” (79 FR 25404). Under Subpart W as promulgated in 1989, an impoundment was in operation when new tailings were being emplaced, from the day that tailings are first placed in the impoundment until the day that final closure begins. There has been some confusion over this definition. We proposed to amend the definition of “operation” in the Subpart W definitions at 40 CFR 61.251 to replace the reference to “new” tailings with the broader term “uranium byproduct material or tailings” at 79 FR 25405.
We received comments from across the spectrum of stakeholders who disliked this definition. Commenters from industry said we did not take into account the period between cessation of placement of uranium byproduct material or tailings into an impoundment and physical closure with an approved closure plan. This period can sometimes last for years while the uranium byproduct material or tailings are dewatered to an extent that heavy machinery can be used to emplace the final closure radon barrier. Also, the impoundment(s) are often used for dismantling the facility, for disposal of other liners, etc. Extending the operational period and Subpart W jurisdiction during the entire closure period could result in a milling facility having two operating impoundments in the closure process and no ability to operate a third impoundment to receive uranium byproduct material or tailings from operations. Other commenters claimed that operators were taking advantage of the existing definition by claiming that an impoundment is “in closure” but taking no concrete action to implement a closure plan or apply a final cover.
We do not intend to extend the jurisdiction of Subpart W to include the period during which closure activities are being conducted. The proposal was intended to clarify that an impoundment remains “operating” until it enters closure, even if it is not receiving newly-generated uranium byproduct material or tailings from facility processing (79 FR 25405). Further, we note that the definition in Subpart W is consistent with those in 40 CFR 192.31 and 10 CFR part 40, Appendix A, which were in fact derived from Subpart W. Thus, we find this concern to be misplaced. The final rule adopts the definition of “operation” as it was proposed.
We did not propose to include a definition of “closure”; however, we realize that a lack of clarity on the concept of closure, what it involves and when it begins has affected the understanding of Subpart W. In particular, the use of the term “final closure” in the definition of “operation” does not, by itself, provide sufficient clarity on the end of operation. As described earlier, we received a number of comments making suggestions or raising concerns on this point. As noted above, the definition of “operation” in Subpart W served as the basis for the definitions later adopted in 40 CFR part 192 and 10 CFR part 40, Appendix A. Further, both 40 CFR part 192 and 10 CFR part 40, Appendix A adopted definitions and requirements related to closure that address some aspects of the comments we received related to Subpart W. The more appropriate action is to retain the definition of “operation” and clarify the meaning of final closure in a separate definition. Therefore, the final rule incorporates a new definition of “final closure” at 40 CFR 61.251(n).
We emphasize two aspects of this new definition that we believe will help address concerns regarding the timeliness and predictability of closure activities. First, impoundments or heap leach piles will remain subject to Subpart W until the owner or operator provides written notice that the impoundment is entering final closure. Second is the reference to the reclamation plan for the impoundment or heap leach pile. We have heard some comments, specifically related to the Cotter mill, that the facility should still be subject to Subpart W because it has never had an approved reclamation or closure plan; however, the facility no longer has an operating license under which it would conduct activities subject to the requirements of Subpart W.
The reference to a reclamation plan in the definition of “final closure” does not affect that Subpart W only applies to operational units and does not cover units that are in closure. Rather, it makes clear our expectation, also found in 40 CFR part 192 and 10 CFR part 40, Appendix A, that the NRC or the Agreement State require and approve such a plan. It also establishes that notice to the NRC or the Agreement State and an approved reclamation plan are necessary prerequisites for determining that the impoundment in question is no longer subject to the requirements of Subpart W. The final rule is adopting the terminology employed in NRC regulations. In 10 CFR part 40, Appendix A, NRC identifies a reclamation plan as applicable to individual impoundments, while the closure plan is a more comprehensive document that addresses all aspects of facility closure and decommissioning, including any necessary site remediation. A reclamation plan prepared and approved in accordance with NRC requirements in 10 CFR part 40, Appendix A, is considered a reclamation plan for purposes of Subpart W. The reclamation plan may be incorporated into the larger facility closure plan.
A number of commenters expressed concern that the issue of delayed closure would have been addressed by 40 CFR part 61, subpart T (40 CFR 61.220-226), which required that impoundments that are no longer accepting tailings be brought into compliance (
We proposed specific provisions for conventional impoundments, non-conventional impoundments and heap leach piles to explicitly convey that any impoundment at a uranium recovery
1. A top liner designed and constructed of materials (
2. A composite bottom liner consisting of at least two components. The upper component must be designed and constructed of materials (
3. A leachate collection and removal system between the liners, which acts as a leak detection system. This system must be capable of detecting, collecting and removing hazardous constituents at the earliest practicable time through all areas of the top liner likely to be exposed to the waste or liquids in the impoundment.
There are other requirements for the design and operation of the impoundment, and these include construction specifications, slope requirements, sump requirements and liquid removal requirements. As part of the proposed rule, we examined these provisions to help determine whether Subpart W adequately addresses extreme weather events. We determined that the requirements in 40 CFR 264.221 satisfactorily address such events.
The proposal did not adopt a new approach. Instead, it carried forward the approach adopted in the 1989 rulemaking. That rulemaking included § 61.252(c), which broadly required all impoundments, including those in existence prior to the promulgation of 40 CFR part 192, to comply with the requirements of 40 CFR 192.32(a). The 1986 rulemaking had not applied the requirements of 40 CFR 192.32(a) to impoundments in existence when the 1986 rule was promulgated, as these impoundments were anticipated to cease accepting uranium byproduct material or tailings by the end of 1992 (51 FR 34066). The 1989 rulemaking lifted this restriction as well as the exemption from the requirements of 40 CFR 192.32(a) (54 FR 51680).
We did not propose to remove the liner requirements or request comment on whether they should be retained. We proposed to refer only to 40 CFR 192.32(a)(1) because § 192.32(a) includes provisions that extend well beyond the design and construction of impoundments, such as ground water monitoring systems and closure requirements. These aspects do not fall under the purview of Subpart W, and they are removed in this action.
This final rule incorporates the revised reference to 40 CFR 192.32(a)(1) for all impoundments that contain uranium byproduct material or tailings and establishes this requirement as an element of GACT-based standards for conventional impoundments, non-conventional impoundments, and heap leach piles. The provision in the 1989 rule that extended this requirement to conventional impoundments in existence as of December 15, 1989 is moved to § 61.252(a)(1), which addresses those impoundments.
We received a comment suggesting that we explicitly cite 40 CFR 264.221(c) as the criteria that all impoundments are required to meet. This provision was not incorporated into regulation until 1985 (50 FR 28747). Adopting the commenter's approach would require impoundments constructed before 1985 to upgrade or close, which we did not propose to require. Those older impoundments are required to comply with the provisions of 40 CFR 264.221 that are applicable to them. The commenter's approach would also eliminate consideration of § 264.221(d), which allows for an alternative design or operating practices if “such design and operating practices, together with location characteristics” would prevent migration of hazardous constituents and allow detection of leaks at least as effectively as the requirements of § 264.221(c). It is not appropriate to eliminate this flexibility, particularly for sites that may employ improved liner materials or have exceptional natural characteristics that lend themselves to such a demonstration.
As described in the preceding section, Subpart W as promulgated in 1989 required impoundments to be constructed in accordance with the requirements cited in 40 CFR 192.32(a). This provision also included the phrase “as determined by the Nuclear Regulatory Commission.”
As described in the preceding section, 40 CFR 192.32(a) also contains provisions related to ground water protection and closure activities, which are not within the scope of Subpart W. It is appropriate that the NRC be the sole regulatory agency for implementing and enforcing these provisions. We proposed to eliminate the phrase “as determined by the Nuclear Regulatory Commission” from Subpart W to clarify that EPA is an approval authority for Subpart W, but specifically for the impoundment engineering and construction requirements in 40 CFR 192.32(a)(1).
We received a number of comments from industry objecting to this change on the grounds that it would create dual regulation with NRC, thus leading to inefficiencies and the potential for one agency to approve an application while the other denied it. We disagree with these commenters, as described in detail in the next section. The final rule eliminates the phrase “as determined by the Nuclear Regulatory Commission” from 40 CFR 61.252(a)(2)(i) and (ii).
We received a number of comments related to the issue of operation and closure, either to extend the jurisdiction of Subpart W or to limit it. Commenters also expressed views on the liner requirements and their relation to groundwater protection or older impoundments. In connection with the liner requirements, a number of commenters disagreed with the proposal to eliminate the phrase “as determined by the Nuclear Regulatory Commission,” suggesting that it will create dual regulation and exceeds our rulemaking authority. Although we did not propose to revise it, we also received some comment related to the definition of “uranium byproduct material or tailings.”
In 1989, in conjunction with the promulgation of Subpart W, the EPA promulgated 40 CFR part 61, subpart T (40 CFR 261.220-226) to address the closure period and final disposal for conventional tailings impoundments (54 FR 51682). Subpart T required closure of impoundments to be complete within two years after ceasing operations.
In 1991, by Memorandum of Understanding (MOU) with the NRC, the two agencies agreed to take action to clarify the timing for closure of impoundments and processing sites. As part of this agreement, the EPA amended 40 CFR part 192 (58 FR 60341, November 15, 1993) and rescinded subpart T (59 FR 36302, July 15, 1994). The NRC subsequently amended 10 CFR part 40, Appendix A, consistent with the EPA's amended 40 CFR part 192 (59 FR 28220, June 1, 1994). The MOU included the goal that all sites could be closed and in compliance with radon emission standards by 1997 or within seven years of the date on which existing operations cease and standby sites enter disposal status. The MOU did not address Subpart W because Subpart W does not apply during closure.
The MOU and subsequent regulatory actions created a more comprehensive and coordinated framework for managing uranium processing wastes. Further, a settlement agreement with stakeholders provided additional detail to the MOU that, in part, allowed the EPA to make a finding under the CAA that the NRC's regulatory program protected public health with an ample margin of safety. This supported the Agency's decision to rescind subpart T.
In their respective rulemakings, the agencies essentially adopted the Subpart W definition of “operation” and included provisions related to closure that would allow certain activities related to waste management during the closure process. Among these were provisions that would allow wastes to be placed in impoundments that were also either in closure or had completed closure (final cover). These authorizations would not change the status of the impoundment or site, as we explained in our rulemaking to amend 40 CFR part 192: “Even if a portion of a site is authorized to remain accessible for disposal of byproduct materials during the closure process or after placement of a permanent radon barrier consistent with the Settlement Agreement, as described above, this will not cause a nonoperational uranium mill tailings disposal site to revert to an operational site as defined by 40 CFR 192.31(q)” (58 FR 60348, November 15, 1993).
Similarly, the NRC addressed this point in its 1993 proposed rule to amend 10 CFR part 40, Appendix A in response to a comment from an NRC Agreement State:
The final rule includes the definition of “operation” as it was proposed, which makes it fully consistent with the definitions in 40 CFR part 192 and 10 CFR part 40, Appendix A. We are also adopting a definition of “final closure” that clarifies that Subpart W does not apply to impoundments that are being managed under an approved reclamation plan for that impoundment or the facility closure plan.
As described in the response to the previous comment, the EPA and the NRC entered into an MOU in 1991, after industry efforts to stay the implementation of subpart T, due, in part, to the fact that the requirement to complete closure of impoundments was unrealistically stringent. As part of the MOU, the EPA rescinded subpart T and modified its UMTRCA standards at 40 CFR 192.32 to address activities conducted during closure, including allowing placement of decommissioning wastes in non-operating impoundments. The EPA and the NRC agreed that such activities can, for the most part, be
The Agency has no plans to reinstate subpart T, although EPA is not precluded from doing so (40 CFR 261.226). Nor is the final rule extending the scope of Subpart W to cover closure activities. While this does leave a period of time when conventional and non-conventional impoundments are more likely to have increased radon emissions because they are not managed as they would be during operations, such a period is necessary to facilitate final closure activities. However, “dewatering” tailings for decades, particularly in the arid West, is certainly not consistent with the seven-year period envisioned by both the EPA and the NRC. Most conventional tailings are emplaced using the phased disposal method. To avoid extended dewatering periods, sites may consider using the continuous disposal method, in which tailings are dewatered before emplacement and immediately covered. Regardless of the method of emplacement, we emphasize the importance of timely closure in achieving the safe end state of these sites, and encourage the NRC and NRC Agreement States to give appropriate attention to controlling radon emissions during closure activities.
As noted by one commenter, closure plans with milestones are required under 40 CFR part 192 and 10 CFR part 40, Appendix A. Closure plan requirements, closure activities and revisions to part 192 are not within the scope of this Subpart W rulemaking. The EPA typically does not see closure plans when reviewing construction applications under 40 CFR part 61, subpart A. The NRC or the Agreement State is responsible for enforcement of reclamation or closure plans. The Cotter site ceased operations several years ago, no longer has an operating license and is therefore no longer subject to the requirements of Subpart W. The site is currently a Superfund site and is conducting activities under a decommissioning license from the State of Colorado.
The final rule includes a definition of “final closure” that specifies notification that the impoundment in question is being managed according to the requirements and milestones in the approved reclamation plan. This should provide clarity when determining whether an impoundment is in closure, and whether Subpart W still applies.
In addition to the use of an impoundment for wastes generated during closure or remediation activities, NRC regulations also provide for waste from other sources to be emplaced in the impoundment during the closure process (10 CFR part 40, Appendix A, Criterion 6(A)(3)). Approval of such emplacement requires a license amendment and must not delay complete closure of the impoundment. Subpart W does not apply to such authorized emplacements while the impoundment is undergoing closure because the unit is subject to an approved reclamation plan and, therefore, no longer operating. Depending on the terms of the license amendment, authorized emplacements at impoundments may include waste from ISL sites, which are not expected to construct permanent impoundments, thereby facilitating the overall goal of limiting the number of small disposal sites. Authorization to allow emplacement of waste from other sources during the closure process must be reflected in both the facility license and the applicable reclamation plan.
One commenter requests clarification of the term “day that final closure begins,” which the commenter believes has never been adequately explained. Another commenter requests clarification on the steps that must take place for closure to begin. Commenters also stated that we did not include non-conventional impoundments in the definition of operation.
Additionally, commenters have misinterpreted our proposal. The Agency does not intend to apply Subpart W to impoundments that have entered the closure process. The proposed modification of the definition of “operation,” which we are adopting in the final rule, clarifies that impoundments that have not yet entered closure remain subject to Subpart W, even if the material they are receiving is not newly-generated uranium byproduct material or tailings (“new tailings” in the original). This also makes the definition more consistent with those in 40 CFR part 192 and 10 CFR part 40, Appendix A. See the proposed rule at 79 FR 25405, May 2, 2014. To further clarify this situation, the final rule includes a definition of “final closure” specifying that closure begins upon written notification that the impoundment is being managed according to the requirements and milestones in the approved reclamation plan for that impoundment.
This definition of “final closure” adopts a suggestion provided by one commenter. The commenter proposed tying “closure period” to a written notification from the licensee that the impoundment is no longer being used for emplacement of tailings or for evaporative or holding purposes, and is also no longer on standby for such purposes. The commenter suggests that it would be useful to explicitly address both conventional and non-conventional impoundments in the definitions, as there may be situations where non-conventional impoundments continue to operate when conventional impoundments are in closure. We are also adopting this suggestion in the definition of “final closure.”
Adding this language should eliminate some uncertainty regarding impoundment status. This uncertainty is reflected in a statement by the same commenter regarding the White Mesa Mill. In providing information about the different impoundments, the commenter notes that “. . . Cell 3
Regarding the perceived conflicts with NRC regulations, we do not see such a conflict, and note that the definition of “operation” in existing and proposed Subpart W is substantively identical to and served as the basis for that in 10 CFR part 40, Appendix A (we note the NRC's statement in its proposal that “the definition of operations is in conformance with the definition of `operational' in the proposed EPA amendment to [40 CFR part 192] subpart D and in 40 CFR part 61, subpart W” (58 FR 58659, November 3, 1993). The commenters did not suggest that the NRC's definition is in conflict with its own regulations. Further, the same definition is used in 40 CFR 192.31(p). As noted above, we are also adding a definition of “final closure” in the final rule. This will provide additional clarity as to what steps the operator must take to remove an impoundment from the jurisdiction of Subpart W while remaining consistent with the definitions in 10 CFR part 40 and 40 CFR part 192. The definition of final closure explicitly addresses conventional impoundments, non-conventional impoundments and heap leach piles.
The phrase “day that final closure begins” was included in the original promulgation of Subpart W in 1986 (51 FR 34056, September 14, 1986). “Final closure” is a term defined under RCRA hazardous waste regulations in 40 CFR 260.10. “Final closure” in that context refers to the closure of all hazardous waste management units at a site, and is distinguished from “partial closure,” which refers to closure of individual units. However, as the term is used in Subpart W, and as it is being adopted in the final rule, it refers to individual impoundments, not the entire site (so is more like “partial closure” in the RCRA context). Subpart W differs in this respect from 40 CFR part 192 and 10 CFR part 40, Appendix A, which are both also concerned with closure of the overall site. We also note that, as described earlier, the definition of “operations” in Subpart W served as the basis for corresponding definitions in 40 CFR part 192 and 10 CFR part 40, Appendix A, and this phrasing has also been adopted in and provides consistency with those regulations. We did not propose to change it and we are not finalizing any changes.
The two impoundments identified by the State of Utah are both required to comply with the liner requirements in 40 CFR 192.32(a)(1), and by extension 40 CFR 264.221. The standby status of the Shootaring Canyon Mill makes no difference in this regard. We understand that some stakeholders did not view the 1989 rulemaking as applicable to liquid (non-conventional) impoundments. This final rule clarifies that non-conventional impoundments did fall under the 1989 rule and are also subject to the requirements in 40 CFR 192.32(a)(1). We note that Denison Mines, the previous owner of the White Mesa Mill, stated in its response to the EPA's section 114 request for information that Cell 1 meets the requirements of 40 CFR 264.221(a).
A number of these commenters asserted that our proposal was contrary to the legal framework established by Congress for management of byproduct material as defined in Section 11e.(2) of the AEA. Commenters cite to the framework in Section 275 of the AEA, which directs the EPA to establish standards for management of byproduct material and which gives the NRC sole authority over implementation and enforcement of the EPA's standards through its licensing process (one commenter cites Title 42 of the United States Code, Section 2022(d) rather than Section 275 of the AEA). Several commenters refer specifically to that section's statement that “no permit issued by the Administrator is required . . . for the processing, possession, transfer, or disposal of byproduct material, as defined in section 11e.(2) to this subsection.” Another commenter suggests that the EPA is attempting to expand its role by improperly assuming or duplicating the NRC's responsibilities.
One commenter does not make these specific statutory references, but more generally criticizes the EPA for “grossly inefficient, dual regulation” that is “inconsistent with efficient regulatory practices” and goes against previous efforts by the two agencies to avoid such situations, as illustrated by the EPA's rescission of 40 CFR part 61, subparts I and T. The commenter suggests that Subpart W could also be rescinded, and notes that the EPA's separate rulemaking related to 40 CFR part 192 may be used to incorporate elements of Subpart W as needed.
We also received some comments in support of the proposal to remove the phrase “as determined by the Nuclear Regulatory Commission.” One commenter believes this is a welcome clarification that the EPA is administering the NESHAP program. Another commenter notes that it is not unusual for an industry to be regulated under more than one statute or agency. A third commenter points out that this situation has existed for several decades. A fourth commenter agrees and cites the EPA approvals under 40 CFR part 61, subpart A, as well as the division of responsibilities at the state level in Utah as they relate to the White Mesa Mill.
The comments confirm that there is a misimpression that this reference to the NRC precluded the EPA from reviewing applications for compliance with 40 CFR 192.32(a)(1) in its pre-construction and modifications reviews under 40 CFR 61.07 and 61.08. That is an incorrect interpretation of the 1989 rule. To the contrary, in promulgating the 1989 rule, we stated “Mill operators will not be allowed to build any new mill tailings impoundment which does not meet this work practice standard. EPA will receive information on the construction of new impoundments through the requirements for EPA to approve of new construction under 40 CFR part 61, subpart A” (54 FR 51682). The referenced “work practice standard” includes the requirement for
Commenters' references to AEA Section 275 as limiting our authority are incorrect. The commenters have overlooked a salient point, which is that the Subpart W rulemaking is being undertaken pursuant to our CAA authority, not under the AEA. Another relevant provision in Section 275, 275e (42 U.S.C. 2022(e)), states: “Nothing in this Act applicable to byproduct material, as defined in section 11e.(2) of this Act, shall affect the authority of the Administrator under the Clean Air Act of 1970, as amended, or the Federal Water Pollution Control Act, as amended.” The Federal Water Pollution Control Act is also known as the Clean Water Act.
Further, commenters who cited the prohibition on EPA permitting neglected to note the context for this provision and the specificity of the language regarding the standards of general application to be developed by the EPA. AEA section 275b.(2) reads as follows: “Such generally applicable standards promulgated pursuant to this subsection for nonradiological hazards shall provide for the protection of human health and the environment consistent with the standards required under subtitle C of the Solid Waste Disposal Act, as amended, which are applicable to such hazards:
Regarding the view of appropriate and efficient regulation, our action will not have such far-reaching consequences. The EPA and the NRC have not examined the prospect of rescinding Subpart W. As with the rescission of 40 CFR part 61, subparts I and T, and in accordance with CAA section 112(d)(9), the EPA would need to determine that the NRC's regulatory program will protect public health with an ample margin of safety. The EPA's separate rulemaking under 40 CFR part 192 specifically addresses ground water protection at ISL facilities.
Another commenter raised a question regarding wastes at uranium recovery facilities that are not derived from ores. The commenter stated that such wastes may derive from “alternate feed” materials that contain sufficient uranium to make processing worthwhile (
We note that the EPA has clear authority to promulgate definitions under the CAA as it deems appropriate and is not limited to the AEA's definition of “byproduct material” or the NRC's definition in 10 CFR 40.4. The EPA's definition identifies the scope of material covered by the Subpart W regulations and does not preempt the NRC's AEA authority. See Section IV.A.2 for more discussion of legal authorities as they relate to this issue.
The definition of “uranium byproduct material or tailings” in Subpart W, as it was promulgated in 1989 and not modified by this rule, establishes that Subpart W broadly addresses radon emissions from operating structures used to manage wastes produced during and following the concentration or extraction of uranium from ore processed primarily for its source material content. The EPA acknowledges that the definition of “uranium byproduct material or tailings,” as originally promulgated in 1989, may not wholly conform with the common understanding of “tailings.” However, the scope and applicability of Subpart W is determined by the regulatory definition of “uranium byproduct material or tailings,” not the common understanding of tailings. Subpart W applies to the structures at uranium recovery facilities that are used to manage or contain “uranium byproduct material or tailings” during and following the processing of uranium ores. Common names for these structures may include, but are not limited to, impoundments, tailings impoundments, tailings piles, evaporation or holding ponds, and heap leach piles. However, the name itself is not important for determining whether Subpart W requirements apply to that structure; rather, applicability is based on what these structures contain. To clarify any potential confusion created by the Subpart W definition, any references to “uranium byproduct material” or “tailings” are now references to “uranium byproduct material or tailings.” These changes reaffirm the scope of Subpart W and are not substantive.
The defined scope of materials subject to Subpart W becomes more meaningful when one considers the current
The designation of restoration fluids as uranium byproduct material or tailings is consistent with the approach taken by the NRC. See Staff Requirements Memorandum—SECY-99-013, “Recommendation on Ways to Improve the Efficiency of NRC Regulation at
It is not necessary for us to explicitly address waste not resulting from the concentration or extraction of ores because Subpart W applies to impoundments, both conventional and non-conventional, that are used to manage uranium byproduct material or tailings. Such impoundments that also contain non-ore wastes continue to be subject to Subpart W. It is unlikely that an operator would construct impoundments for the sole purpose of managing wastes that do not derive from the processing of ores. As explained in Section IV.E.2, the purpose of Subpart W is to control radon emissions from sources containing uranium byproduct material or tailings at uranium recovery facilities. If an impoundment does not contain uranium byproduct material or tailings, it is not subject to the requirements of Subpart W. If construction of such impoundments is planned, they can be identified and their status can be addressed during the construction application review under subpart A.
As discussed earlier, uranium recovery activities are carried out at several different types of facilities. We are revising Subpart W based on how uranium recovery facilities manage uranium byproduct materials during and after the processing of uranium ore at their particular facility. As discussed in Sections III and IV, we are establishing GACT-based requirements for three types of affected sources at uranium recovery facilities: (1) Conventional impoundments; (2) non-conventional impoundments; and (3) heap leach piles.
For purposes of analyzing the impacts of the final rule, we assumed that approximately five conventional milling facilities, 50 ISL facilities (although this is only a projection since only 12 are fully licensed) and one heap leach facility, each with at least one regulated impoundment, are subject to the final Subpart W. The following sections present our estimates of the final rule's air quality, cost and economic impacts. For more information, please refer to the Economic Impact Analysis (EIA) report that is included in the public docket for this final rule (EPA-HQ-OAR-2008-0218).
The requirements in this final rule should eliminate or reduce radon emissions at all three types of affected sources. The GACT-based standards being established by this action are based on control technologies and management practices that have been used at uranium recovery facilities for the past twenty or more years. These standards will minimize the amount of radon that is released to the air by keeping the impoundments wet or covered with soil and/or by limiting the area of exposed uranium byproduct material or tailings.
Table 5 presents a summary of the unit cost (per pound of U
A reference facility for each type of uranium recovery facility is developed and described in Section 6.2 of the EIA, including the base cost estimate to construct and operate each of the three types of reference facilities. For comparison purposes, the unit cost (per pound of U
Based on the information in Table 5, the four GACT-based standards represent about 4%, 6%, and 5% of the baseline cost (per pound of U
Baseline costs for conventional impoundment liner construction
The average cost to construct one of these impoundments is $13.8 million. We estimate that this cost is less than 2% of the total baseline costs to construct and operate a conventional mill, per pound of U
We have estimated that for an average 80-acre non-conventional impoundment the average cost of construction of an impoundment is $24.7 million. Requiring impoundments to comply with the liner requirements in 40 CFR 192.32(a)(1) will contain the uranium byproduct material and reduce the potential for ground water contamination. The only economic impact attributable to the final rule is the cost of complying with the new requirement to maintain liquids such that solids in the non-conventional impoundments are not visible above the liquid level during operation and standby. As explained in Section IV.B.3. of this preamble, as long as solid materials are maintained in a saturated state in the non-conventional impoundments the effective radon emissions from the ponds are reduced by approximately 95%. In order to maintain a liquid surface above the sediments within a pond, it is necessary to replace the water that is evaporated from the pond. Depending on the source of water chosen, we estimate that this requirement will cost owners or operators of non-conventional impoundments between $2,909 and $37,527 per year.
Designing and constructing heap leach piles to meet the requirements at 40 CFR 192.32(a)(1) will minimize the potential for leakage of uranium enriched lixiviant into the ground water. Specifically, this will require that a double liner, with drainage collection capabilities, be provided under heap leach piles. Baseline costs for heap leach pile liner construction will remain the same, since the final rule does not impose additional requirements. Liners meeting the requirements at 40 CFR 192.32(a)(1) are already mandated by other regulations and, therefore, built into the baseline cost estimate. Therefore there are consequently no costs (or benefits) resulting from the inclusion of these requirements in Subpart W. Baseline costs for construction will be essentially the same as for conventional impoundments. Since the liner systems are equivalent to the systems used for conventional and non-conventional impoundments, we have been able to estimate the average costs associated with the construction of heap leach pile impoundments that meet the liner requirements we are proposing, and compare them to the costs associated with the total production of uranium produced by the facility. The average cost of constructing such an impoundment is estimated to be approximately $12.6 million. The costs of constructing this type of liner system are less than 5% of the estimated total baseline costs of a heap leach facility.
In summary, we estimate that for conventional impoundments there will be no additional costs incurred through this proposed rule. For non-conventional impoundments we estimate that the additional costs incurred by this proposed rule will be to maintain a layer of liquid above solid materials in each non-conventional impoundment, and we have estimated those costs between approximately $2,909 and $37,527 per year, which represents less than $0.03 per pound of U
Water quality will be maintained by implementation of this final rule. This final rule does contain requirements (by reference) related to water discharges and spill containment. In fact, the liner requirements cross referenced at 40 CFR 192.32(a)(1) will significantly decrease the possibility of contaminated liquids leaking from impoundments into ground water (which can be a
Including a double liner in the design of all onsite impoundments that would contain uranium byproduct material or tailings will reduce the potential for groundwater contamination. Although the amount of the potential reduction is not quantifiable, it is important to take this into consideration due to the significant use of ground water as a source of drinking water.
Additional information about these statutes and Executive Orders can be found at
This action is a significant regulatory action that was submitted to OMB for review. The Executive Order (E.O.) defines “significant regulatory action” as one that is likely to result in a rule that may “raise novel legal or policy issues arising out of legal mandates, the President's priorities, or the principles set forth in the Executive Order.” Any changes made in response to OMB recommendations have been documented in the docket for this action. The EPA prepared an economic analysis of the potential costs and benefits associated with this action. This analysis, “Technical and Regulatory Support to Develop a Rulemaking to Modify the NESHAP Subpart W Standard for Radon Emissions from Operating Mill Tailings (Background Information Document and Economic Impact Analysis),” Docket No. EPA-HQ-OAR-2008-0218, is available in the docket and summarized in Section V of this preamble. This action is not a significant economic action.
The information collection requirements in this rule have been submitted for approval to OMB under the PRA. The Information Collection Request (ICR) document prepared by the EPA has been assigned EPA ICR number 2464.02. You can find a copy of the ICR in the docket for this rule, and it is briefly summarized here. The information collection requirements are not enforceable until OMB approves them.
The information to be collected for the rule is based on the requirements of the CAA. Section 114 authorizes the Administrator of the EPA to require any person who owns or operates any emission source or who is subject to any requirements of the Act to:
EPA's regional offices use the information collected to ensure that public health continues to be protected from the hazards of radionuclides by compliance with health based standards and/or GACT.
The rule requires the owner or operator of a uranium recovery facility to maintain records that confirm that the conventional impoundment(s), non-conventional impoundment(s) and heap leach pile(s) meet the requirements in § 192.32(a)(1). Included in these records are the results of liner compatibility tests and documentation that a layer of liquid above solid materials has been maintained in non-conventional impoundments. This documentation should be sufficient to allow an independent auditor (such as an EPA inspector) to verify the accuracy of the determination made concerning the facility's compliance with the standard. These records must be kept at the mill or facility for the operational life of the facility and, upon request, be made available for inspection by the Administrator, or his/her authorized representative. The rule requires the owners or operators of operating non-conventional impoundments to submit digital photographs taken during the compliance inspections required in section 61.252(b). The recordkeeping requirements require only the specific information needed to determine compliance. We have taken this step to minimize the reporting requirements for small business facilities.
The annual monitoring and recordkeeping burden to affected sources for this collection (averaged over the first three years after the effective date of the final rule) is estimated to be 6,693 hours with a total annual cost of $336,950 for the requirements related to documenting the liquid level in non-conventional impoundments, and a one-time expenditure of 460 hours and $32,890 to maintain records of impoundment design and construction. This estimate includes a total capital and start-up cost component annualized over the facility's expected useful life and a purchase of services component. We estimate that this total burden will be spread over 23 facilities that will be required to keep records.
Burden is defined at 5 CFR 1320.3(b). An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. The OMB control numbers for EPA's regulations in 40 CFR are listed in 40 CFR part 9. When OMB approves this ICR, the Agency will announce that approval in the
I certify that this action will not have a significant economic impact on a substantial number of small entities under the RFA. The small entities subject to the requirements of this action are small businesses whose company has less than 250 employees and is primarily engaged in leaching or beneficiation of uranium, radium or vanadium ores as defined by NAICS code 212291.
The EPA has determined that small entities subject to the requirements of
This action does not contain an unfunded mandate of $100 million or more as described in UMRA, 2 U.S.C. 1531-1538, and does not significantly or uniquely affect small governments. The final rule imposes no enforceable duty on any state, local or tribal governments or the private sector. Thus, this rule is not subject to the requirements of sections 202 or 205 of UMRA.
This rule is also not subject to the requirements of section 203 of UMRA because it contains no regulatory requirements that might significantly or uniquely affect small governments because it contains no requirements that apply to such governments nor does it impose obligations upon them.
This action does not have federalism implications. It will not have substantial direct effects on the states, on the relationship between the national government and the states, or on the distribution of power and responsibilities among the various levels of government. None of the facilities subject to this action are owned and operated by State governments and nothing in the final rule will supersede State regulations. Thus, E.O. 13132 does not apply to this final rule.
This action does not have tribal implications, as specified in Executive Order 13175. The action imposes requirements on owners and operators of specified area sources and not tribal governments. Thus, Executive Order 13175 does not apply to this action.
The EPA notes, however, that several tribes or tribal groups expressed interest in this rulemaking due to the proximity of some of the facilities regulated under Subpart W to tribal lands. Consistent with the EPA Policy on Consultation and Coordination with Indian Tribes, the EPA consulted with tribal officials of the Ute Mountain Ute Tribe during development of this action. A summary of that consultation is provided in Docket No. EPA-HQ-OAR-2008-0218-0120.
This action is not subject to Executive Order 13045 because it is not economically significant as defined in Executive Order 12866. This action's health and risk assessments are contained in Section IV.B.2 of this preamble and in the Background Information Document prepared to support this action (Docket No. EPA-HQ-OAR-2008-0218). The updated risk assessment described in Section IV.B.2 incorporated the risk coefficients from Federal Guidance Report (FGR) No. 13, “Cancer Risk Coefficients for Environmental Exposure to Radionuclides,” which includes age-averaged factors to convert radionuclide exposure (intake) to health risk. FGR 13 was developed subsequent to the risk assessment conducted to support the 1989 rulemaking, which relied upon factors applicable to adults. FGR 13 is undergoing revision.
This action is not a “significant energy action” because it is not likely to have a significant adverse effect on the supply, distribution, or use of energy. This final rule will not adversely directly affect productivity, competition, or prices in the energy sector.
This rulemaking does not involve technical standards. The rule retains requirements for radon monitoring using Method 115 that were promulgated in 1989.
The EPA believes that this action does not have disproportionately high and adverse human health or environmental effects on minority populations, low-income populations and/or indigenous peoples, as specified in Executive Order 12898 (59 FR 7629, February 16, 1994). The documentation for this decision is contained in Section IV.B.2 of this preamble and the Background Information Document prepared to support this action (Docket No. EPA-HQ-OAR-2008-0218).
This action is subject to the CRA, and the EPA will submit a rule report to each House of the Congress and to the Comptroller General of the United States. This action is not a “major rule” as defined by 5 U.S.C. 804(2).
Environmental protection, Air pollution control, Hazardous substances, Radon, Tailings, Byproduct, Uranium, Reporting and recordkeeping requirements.
For the reasons stated in the preamble, the Environmental Protection Agency amends title 40, Chapter I of the Code of Federal Regulations as follows:
42 U.S.C. 7401
(b)
(c)
(d)
(e)
(f)
(h)
(i)
(j)
(k)
(l)
(m)
(n)
(1) A conventional impoundment is no longer receiving uranium byproduct material or tailings, is no longer on standby for such receipt and is being managed under an approved reclamation plan for that impoundment or facility closure plan; or
(2) A non-conventional impoundment is no longer required for evaporation or holding purposes, is no longer on standby for such purposes and is being managed under an approved reclamation plan for that impoundment or facility closure plan; or
(3) A heap leach pile has concluded its operational life and is being managed under an approved reclamation plan for that pile or facility closure plan.
(o)
(a) Each owner or operator of a conventional impoundment shall comply with the following requirements:
(1) Radon-222 emissions to the ambient air from an existing conventional impoundment shall not exceed 20 pCi/(m
(2) After December 15, 1989, no new conventional impoundment may be built unless it is designed, constructed and operated to meet one of the two following management practices:
(i) Phased disposal in lined impoundments that are no more than 40 acres in area and comply with the requirements of 40 CFR 192.32(a)(1). The owner or operator shall have no more than two conventional impoundments, including existing conventional impoundments, in operation at any one time.
(ii) Continuous disposal such that uranium byproduct material or tailings are dewatered and immediately disposed with no more than 10 acres uncovered at any time and shall comply with the requirements of 40 CFR 192.32(a)(1).
(b) Each owner or operator of a non-conventional impoundment shall comply with the following requirements: Non-conventional impoundments shall meet the requirements of 40 CFR 192.32(a)(1). During operation and until final closure begins, the liquid level in the impoundment shall be maintained so that solid materials in the impoundment are not visible above the liquid surface, verified by daily inspections documented through notations and by digital photographic evidence collected at least weekly. Should inspection reveal that solid materials in the impoundment are visible above the liquid surface, the owner or operator must correct the situation within seven days, or other such time as specified by the Administrator.
(c) Each owner or operator of a heap leach pile shall comply with the following requirements: Heap leach piles that have completed their operating life but have not yet entered final closure shall be managed in compliance with the phased disposal management practice in paragraph (a)(2)(i) of this section. Heap leach piles shall be constructed in lined impoundments that are no more than 40 acres in area and shall comply with the requirements of 40 CFR 192.32(a)(1). The owner or operator shall have no more than two heap leach piles, including existing heap leach piles, subject to this subpart at any one time.
(a) The owner or operator of any uranium recovery facility must maintain records that confirm that the conventional impoundment(s), non-conventional impoundment(s) and heap leach pile(s) subject to this subpart at the facility meet the requirements in 40 CFR 192.32(a)(1). These records shall
(b) The owner or operator of any uranium recovery facility with non-conventional impoundments must maintain written records from daily inspections and other records confirming that any sediments have remained saturated in the non-conventional impoundments at the facility. Periodic digital photographic evidence, with embedded date stamp and other identifying metadata, shall be collected no less frequently than weekly to demonstrate compliance with the requirements of § 61.252(b). Should inspection reveal that a non-conventional impoundment is not in compliance with the requirements of § 61.252(b), the owner or operator shall collect photographic evidence before and after the non-compliance is corrected.
(c) The records required in paragraphs (a) and (b) in this section must be kept at the uranium recovery facility for the operational life of the facility and must be made available for inspection by the Administrator, or his authorized representative.
(1) Digital photographs taken to demonstrate compliance with the requirements of § 61.252(c) shall be submitted electronically using the Subpart W Impoundment Photographic Reporting (SWIPR) system that is accessed through EPA's Central Data Exchange (CDX) (
(i) Owners and operators must also submit information identifying the facility and facility location, the name or other designation of each impoundment, and the date and time of each photograph.
(ii) If the reporting form specific to this subpart is not available in SWIPR, the owner or operator must retain the digital photographs at the facility and provide them to the EPA or authorized State upon request, with the supporting information required in paragraph (c)(1)(i) of this section.
(2) [Reserved]
Environmental Protection Agency (EPA).
Final rule.
In this action, the Environmental Protection Agency (EPA) promulgates revisions to the
This rule is effective February 16, 2017. For all regulatory applications covered under the
This final rule also starts a 3-year transition period that ends on January 17, 2020 for transportation conformity purposes. Any refined analyses that are started before the end of this 3-year period, with a preferred appendix A model based on the 2005 version of the
All applicants are encouraged to consult with their respective reviewing authority as soon as possible to assure acceptance of their modeling protocols and/or modeling demonstration during either of these periods.
The EPA has established a docket for this action under Docket ID No. EPA-HQ-OAR-2015-0310. All documents in the docket are listed on the
Mr. George M. Bridgers, Air Quality Assessment Division, Office of Air Quality Planning and Standards, U.S. Environmental Protection Agency, Mail code C439-01, Research Triangle Park, NC 27711; telephone: (919) 541-5563; fax: (919) 541-0044; email:
The following topics are discussed in this preamble:
This action applies to federal, state, territorial, local, and tribal air quality management agencies that conduct air quality modeling as part of State Implementation Plan (SIP) submittals and revisions, New Source Review (NSR) permitting (including new or modifying industrial sources under Prevention of Significant Deterioration (PSD)), conformity, and other air quality assessments required under EPA regulation. Categories and entities potentially regulated by this action include:
In addition to being available in the docket, electronic copies of the rule and related materials will also be available on the Worldwide Web (WWW) through the EPA's Support Center for Regulatory Atmospheric Modeling (SCRAM) Web site at
This final rule is nationally applicable, as it revises the
The
The EPA originally published the
On July 29, 2015, we proposed revisions to the
Section IV provides a brief discussion of comments received and our responses that support the changes to the
To inform the development of our proposed revisions to the
The Eleventh Conference on Air Quality Modeling was held August 12-13, 2015, in continuing compliance with CAA section 320. The Eleventh Modeling Conference included the public hearing for this action. The conference began with a thorough overview of the proposed revisions to the
At the conclusion of these presentations, the public hearing on the proposed revisions to the
In this action, the EPA is finalizing two types of revisions to the
The EPA recognizes that the scope and extent of the final changes to the
In this section, we offer summaries of the substantive comments received and our responses and explain the final changes to the
Air quality modeling involves estimating ambient concentrations using scientific methodologies selected from a range of possible methods, and should utilize the most advanced practical technology that is available at a reasonable cost to users, keeping in mind the intended uses of the modeling and ensuring transparency to the public. With these revisions, we believe that the
We proposed revisions to the
As discussed in the preamble to the proposed rule, the EPA's PSD permitting regulations specify that “[a]ll applications of air quality modeling involved in this subpart shall be based on the applicable models, data bases, and other requirements specified in appendix W of this part (
Ambiguity could arise because the
Considering the non-mandatory language used throughout the
Although appendix W has been promulgated as codified regulatory text, appendix W provides permit issuers broad latitude and considerable flexibility in application of air quality modeling. Appendix W is replete with references to “recommendations,” “guidelines,” and reviewing authority discretion.
Although this approach appears throughout the
In our proposed action, we invited comments on the proposed scientific updates to the regulatory version of the AERMOD modeling system, including:
1. A proposed “ADJ_U*” option incorporated in AERMET to adjust the surface friction velocity (u*) to address issues with AERMOD model tendency to overprediction from some sources under stable, low wind speed conditions.
2. A proposed “LOWWIND3” option in AERMOD to address issues with model tendency to overprediction under low wind speed conditions. The low wind option increases the minimum value of the lateral turbulence intensity (sigma-v) from 0.2 to 0.3 and adjusts the dispersion coefficient to account for the effects of horizontal plume meander on the plume centerline concentration. It also eliminates upwind dispersion, which is incongruous with a straight-line, steady-state plume dispersion model, such as AERMOD.
3. Modifications to AERMOD formulation to address issues with model tendency to overprediction for applications involving relatively tall stacks located near relatively small urban areas.
4. Proposed regulatory options in AERMOD to address plume rise for horizontal and capped stacks based on the July 9, 1993, Model Clearinghouse memorandum,
5. A proposed buoyant line source option, based on the Buoyant Line and Point Source (BLP) model, incorporated in AERMOD.
6. Proposed updates to the NO
The EPA's final action related to each of these proposed updates is discussed below.
The EPA has integrated the ADJ_U* option into the AERMET meteorological processor for AERMOD to address issues with model overprediction of ambient concentrations from some sources associated with underprediction of the surface friction velocity (u*) during light wind, stable conditions. The proposed update to AERMET included separate ADJ_U* algorithms for applications with and without the Bulk Richardson Number (BULKRN) option in AERMET. The ADJ_U* option with BULKRN utilizes measured vertical temperature difference data (
The majority of public comments supported the adoption of the ADJ_U* option in AERMET, while a few commenters expressed concern regarding the potential for the ADJ_U* option to underestimate ambient concentrations. Some commenters also expressed concern regarding the appropriateness of the field study databases used in the EPA model evaluations. We acknowledge the issues and potential challenges associated with conducting field studies for use in model performance evaluations, especially during stable light wind conditions, given the potentially high degree of variability that may exist across the modeling domain and the increased potential for microscale influences on plume transport and dilution. This variability is one of the reasons that we discourage placing too much weight on modeled versus predicted concentrations paired in time and space in model performance evaluations. This also highlights the advantages of conducting field studies that utilize circular arcs of monitors at several distances to minimize the potential influence of uncertainties associated with the plume transport direction on model-to-monitor comparisons. The 1974 Idaho Falls, Idaho, and 1974 Oak Ridge, Tennessee, field studies,
Initial evaluations of the ADJ_U* option in AERMET and LOWWIND options in AERMOD were first presented as “beta” options in appendix F of the AERMOD User's Guide Addendum for version 12345. This included results for the Idaho Falls and Oak Ridge field studies. Updated evaluations based on these NOAA studies were included in the AERMOD User's Guide Addendum for v15181, along with additional evaluations for the Lovett database involving a tall stack with nearby complex terrain. Additional evaluations of these proposed modifications to AERMET and AERMOD were also presented at the Eleventh Modeling Conference, including an evaluation based on the 1993 Cordero Mine PM
One commenter provided a detailed modeling assessment of the proposed ADJ_U* option in AERMET (as well as the proposed LOWWIND3 option in AERMOD) across a number of field studies to support their position that the proposed model updates will “reduce model accuracy” and “in some cases quite significantly reduce[s] modeled impacts, particularly so in the case of the Tracy validation study data.” The EPA's review of the modeling results provided by the commenter indicated almost no influence of the ADJ_U* option on those field studies associated with tall stacks in flat terrain, including the Baldwin and Kincaid field studies. These results are expected since the “worst-case” meteorological conditions for tall stacks in flat terrain generally occur during daytime convective conditions that are not affected by the ADJ_U* option. In addition, the commenter's modeling results presented for the Lovett field study, a tall stack with nearby complex terrain, appear to show improved performance (with less underprediction) with the ADJ_U* option as compared to the default option in AERMET, thereby supporting use of the ADJ_U* option in appropriate situations.
The commenter also stated that the issue of underprediction with the ADJ_U* option is “particularly so in the case of the Tracy validation study.” The Tracy field study involved a tall stack located with nearby terrain similar to the Lovett field study; however, the Tracy field study differs from the Lovett and other complex terrain field studies in that Tracy had the most extensive set of site-specific meteorological data, including several levels of wind speed, wind direction, ambient temperature, and turbulence parameters (
After proposal, the EPA received several requests through its Model Clearinghouse (MCH) for alternative model approval of the ADJ U* option under section 3.2.2 of the
To evaluate the public comments in light of these MCH concurrences, the EPA has conducted additional meteorological data degradation analyses for the Tracy field study and
The results of this EPA study confirm good performance for the Tracy field study using the full set of meteorological inputs with the default options (
Based on these detailed findings, the public cannot be assured that the proposed ADJ_U* option, when used with site-specific meteorological inputs including turbulence data (
While these findings suggest that the ADJ_U* option is not appropriate for use in regulatory applications involving site-specific meteorological data that include measured turbulence parameters, the model performance and diagnostic evaluations strongly support the finding that the ADJ_U* option provides for an appropriate adjustment to the surface friction velocity parameter when standard National Weather Service (NWS) airport meteorological data, site-specific meteorological data without turbulence parameters, or prognostic meteorological input data are used for the regulatory application.
Therefore, based on these findings of improved model performance with the ADJ_U* option for sources where peak impacts are likely to occur during low wind speed and stable conditions, as well as the peer-reviewed studies demonstrating improved estimates of the surface friction velocity (u*) based on these options, the EPA is adopting the proposed ADJ_U* option in AERMET as a regulatory option for use in AERMOD for sources using standard NWS airport meteorological data, site-specific meteorological data without turbulence parameters, or prognostic meteorological inputs derived from prognostic meteorological models.
In addition to the ADJ_U* option in AERMET, the EPA also proposed the incorporation of LOWWIND3 as a regulatory option in AERMOD to address issues with model overprediction for some sources under low wind speed conditions. Beginning with version 12345 of AERMOD, two LOWWIND “beta” options were included in AERMOD (
The current default option in AERMOD uses a minimum sigma-v of 0.2 meters per second (m/s). Setting a higher minimum value of sigma-v would tend to increase lateral dispersion during low wind conditions and, therefore, could reduce predicted ambient concentrations. It is also worth noting that the values of sigma-v derived in AERMOD are based on the dispersion parameters generated in AERMET (
The majority of commenters supported the EPA's proposal to incorporate the LOWWIND3 option into the regulatory version of AERMOD because they believed it would provide a more realistic treatment of low wind situations and reduce the potential for overprediction of the current regulatory version of AERMOD for such conditions. However, one commenter indicated that the proposed
Another aspect of the AERMOD model formulation that may contribute to an increasing bias toward underprediction with distance is the treatment of the “inhomogeneous boundary layer” (IBL) that accounts for changes in key parameters such as wind speed and temperature with height above ground. The IBL approach determines “effective” values of wind speed, temperature, and turbulence that are averaged across a layer of the plume between the plume centerline height and the height of the receptor. The extent of this layer depends on the vertical dispersion coefficient (
Several commenters recommended that the EPA's proposed revisions to AERMOD be further evaluated given either the lack or paucity of peer-reviewed literature upon which they are based. Specifically, one commenter noted that “while this overprediction phenomenon can occur under certain conditions, additional studies produced by a more diverse group of organizations should be evaluated.” Unlike the situation with the ADJ_U* option, the EPA does not have a published, peer-reviewed model formulation update with supporting model performance evaluations that fully address the complex issues of concern for the LOWWIND options. Therefore, the EPA agrees with commenters that additional study and evaluation is warranted for the proposed LOWWIND3 option, as well as other low wind options, in order to gain the understanding across the modeling community that is necessary to determine whether it would be appropriate to incorporate it into an EPA-preferred model used to inform regulatory decisions. The EPA will continue to work with the modeling community to further assess the theoretical considerations and model performance results under relevant conditions to inform considerations for appropriate adjustments to the default minimum value of sigma-v from 0.2 m/s that, as noted by some commenters, may be considered separate from any specific LOWWIND option.
Based on EPA's review of public comments and further consideration of the issues, the public cannot be assured that the proposed LOWWIND3 option does not have a tendency to bias model predictions towards underestimation (especially in combination with the ADJ_U* option and/or site-specific turbulence parameters), which would be inconsistent with section 3.2.2 of the
As proposed, the EPA recognized the need to address observed overpredictions by AERMOD when applied to situations involving tall stacks located near small urban areas. The tendency to overpredict concentrations results from an unrealistic limit on plume rise imposed within the dispersion model. The EPA received broad support in the public comments for these proposed modifications to the AERMOD formulation that appropriately address overprediction for applications involving relatively tall stacks located near small urban areas. The EPA is finalizing this model formulation update, as proposed, into the regulatory version of AERMOD.
As proposed, the EPA updated the regulatory options in AERMOD to address plume rise for horizontal and capped stacks based on the July 9, 1993, MCH memorandum,
As proposed, the EPA has integrated the BLP model into the AERMOD modeling system and removed BLP from appendix A as a preferred model. The comments received on the BLP integration into AERMOD are summarized in four categories: (1) Strongly supportive of the integration and replacement of BLP; (2) supportive of the integration, but with concerns that the integration of BLP is not fully consistent with the dispersion algorithms in AERMOD; (3) supportive of the integration, but suggestive that more time is needed to evaluate the implementation and that BLP should remain in appendix A until more evaluation can be made of the new code; and (4) concerned that modeled concentrations between the original BLP and BLP integrated in AERMOD are not identical. Despite the concerns expressed, all the comments received
The EPA's integration of BLP into AERMOD was not intended to update the model science within BLP into AERMOD. Thus, while the comments relating to inconsistencies between AERMOD (
Therefore, the EPA is integrating the BLP model into the AERMOD modeling system, is removing BLP from appendix A as an EPA-preferred model, and is updating the summary description of the AERMOD modeling system to appendix A of the
In the proposed action, we solicited comments on whether we have reasonably addressed technical concerns regarding the 3-tiered demonstration approach and specific NO
The proposed modifications specifically included: (1) Replacing the existing Tier 2 Ambient Ratio Method (ARM)
First, several commenters stated that the proposed default NO
Second, several commenters noted that the specific version of PVMRM2 intended for regulatory use was not entirely clear. Version 15181 of AERMOD included both PVMRM and PVMRM2 with the proposal preamble text indicating that we would be promulgating PVMRM2; however, the proposed regulatory text identified PVMRM, which caused confusion. The methodology employed in the “PVMRM2” option in AERMOD version 15181 is now the “PVMRM” regulatory option in AERMOD, and the methodology employed in the “PVMRM” option in AERMOD version 15181 has been removed entirely from the model. The basis for this decision is that the updated PVMRM2 is a more complete implementation of the PVMRM approach outlined by Hanrahan (1999) than the original PVMRM implementation in AERMOD.
Therefore, the EPA is updating the regulatory version of the AERMOD modeling system to reflect these changes for NO
As described throughout section IV.A.2 of this preamble, we are revising the summary description of the AERMOD modeling system in appendix A of the
In our proposed action, we invited comment on the incorporation of AERSCREEN into the
We received some comments that SCREEN3 should be retained as it is simpler to use than AERSCREEN. The EPA disagrees with those comments and reminds users that AERSCREEN is already being utilized by much of the stakeholder community and represents the state of the science as stated in the paragraph above. Given the preferred status of AERMOD over ISC and the fact that AERSCREEN is now incorporating fumigation, an option available in SCREEN3, we feel that there are no valid technical reasons to retain SCREEN3 as a recommended screening model.
We also received comments expressing concerns about the fumigation options and conservatism of the fumigation outputs. The fumigation options implemented in AERSCREEN are the same algorithms used in SCREEN3, such that the current capabilities in that screening model are now available in AERSCREEN. However, these fumigation options take advantage of the AERMOD equations for the dispersion parameters sigma-y and sigma-z that are needed for the fumigation calculations. AERSCREEN also takes advantage of the meteorological data generated by MAKEMET to calculate those parameters based on the boundary layer algorithms included in AERMET, as opposed to using standard dispersion curves used by SCREEN3. Some commenters suggested that the Shoreline Dispersion Model (SDM) algorithms be investigated for fumigation calculations. We agree with these commenters and will investigate the incorporation of the SDM algorithms in AERSCREEN for a future release. One commenter noted a bug in building outputs when running AERSCREEN with downwash and user-supplied BPIPPRM input files. The commenter stated that AERSCREEN takes the maximum and minimum dimensions over the 36 directions output by BPIPPRM for use in modeling. For some directions, there may be no building influence and AERSCREEN erroneously takes a zero dimension as a building width. The EPA has determined that this is not a bug in AERSCREEN. Rather, it is a product of the output of BPIPPRM, which may report a value of zero for building widths and, thus, AERSCREEN reports a value of zero as a minimum building width. To address this issue, we have modified AERSCREEN to only output non-zero widths.
Finally, several commenters pointed out a typographical error in the AERSCREEN conversion factors from 1-hour to 3-, 8-, and 24-hour and annual results in section 4.2.1.1 of the
Therefore, the EPA is incorporating AERSCREEN into the
We solicited comment on our proposal to replace CALINE3
The mobile source modeling applications under the CAA requirements that are most affected by the replacement of CALINE3 with AERMOD are transportation conformity hot-spot analyses for PM
The EPA received several comments supporting and several comments opposed to the proposed replacement of CALINE3 with AERMOD as the preferred appendix A model for mobile source emissions. The commenters who supported the proposed replacement agreed with the reasons set forth in the proposal, mainly that AERMOD reflects the state-of-the-science for Gaussian plume dispersion models, with on-going updates and enhancements supported by the EPA, has more accurate performance and is more flexible and can be applied to more project types than other dispersion models, can utilize more recent and more representative meteorological data, and that a single model will generally streamline the process of conducting and securing approval of model demonstrations.
The adverse comments related to the sufficiency of the EPA's technical and scientific basis for the replacement of
First, the EPA notes that, based on implementation of conformity requirements to date, the majority of PM hot-spot analyses have been conducted with AERMOD and its existing algorithms have been used to perform these analyses. While it is true that AERMOD does not have an explicit line-source algorithm, it does have a LINE source input pathway that mimics the input requirements for CALINE3 and simplifies using elongated area sources such as roadways. While roadway sources are often described as “line sources,” they are in fact three-dimensional entities. The roadway width is one of the model inputs for CALINE3 and the width of a roadway is frequently many times the distance from the edge of the roadway to the closest receptor. The actual formulation of these source types is not as explicit as the names suggest. For example, LINE source in AERMOD performs an explicit numerical integration of emissions from the LINE source, whereas CALINE uses a rough integration based on a series of finite line segments. Thus, an elongated area source in AERMOD is likely to represent the distribution of roadway emissions more accurately than the approach taken in CALINE3. In fact, the body of literature focused on roadway emissions suggests that the formulation of the Gaussian plume (
These commenters also believed that the Heist (2013) journal article
In terms of regulatory applications, AERMOD has been demonstrated to be useful for a range of transportation applications and is generally relied on over CAL3QHCR for more complicated projects because of its greater flexibility in source types (
Comments were also made with respect to potential longer AERMOD model run times and the time necessary to set up model files and obtain meteorological data. These statements are not entirely reflective of the EPA's experience to date in implementing the PM hot-spot requirement. The EPA believes that AERMOD has been used for more complicated projects, since PM hot-spot analyses are completed for projects that are often very large and involve different project components that significantly increase the number of diesel vehicles. By their nature, these types of transportation projects involve more time to set up and complete and few transportation modelers have actually run both CAL3QHCR and AERMOD for equivalent projects.
In response to the comments received and based on the analysis conducted by the EPA, the following actions are being taken in the final rulemaking:
• The EPA is replacing CALINE3 with AERMOD as the appendix A preferred model for refined modeling for mobile source applications. The EPA has reviewed the available literature and conducted its own analysis
• The EPA acknowledges that the implementation of AERMOD for all refined modeling may take time, as many state transportation departments are not yet experienced with the AERMOD modeling system. Many states may have attended one of the EPA's multiple trainings but have not been involved in a quantitative PM hot-spot analysis to date. Thus, we are providing an extended 3-year transition period before AERMOD is required as the sole dispersion model for refined modeling in transportation conformity determinations. In addition, any refined analyses for which the air quality modeling was begun before the end of this 3-year period with a CALINE3-based model can be completed after the end of the transition period with that model, similar to the way the transportation conformity grace period for new emissions models is implemented.
• The EPA acknowledges that there are limited demonstrations of using AERMOD for multi-source screening and that additional development work is necessary to develop an AERMOD-based screening approach for CO that satisfies the need for this type of analysis. Thus, we have modified section 4.2.3.1(b) of the
• Finally, the EPA has formally recommended the establishment of a standing air quality modeling workgroup with the U.S. Department of Transportation, including the Federal Highway Administration, Federal Transit Administration, and FAA, to continue to evaluate and develop modeling practices for the transportation sector to ensure that future updates to dispersion models and methods reflect the latest available science and implementation.
See the docket for this action for the Response to Comments document for this part of the proposal as well as the EPA's latest technical support document (TSD) for using AERMOD for CO hot-spot screening analyses.
As discussed in our proposed action, on January 4, 2012, the EPA granted a petition submitted on behalf of the Sierra Club on July 28, 2010,
The first tier involves use of technically credible relationships between precursor emissions and a source's impacts that may be published in the peer-reviewed literature, developed from modeling that was previously conducted for an area by a source, a governmental agency, or some other entity and that is deemed sufficient, or generated by a peer-reviewed reduced form model. The second tier involves application of more sophisticated case-specific chemical transport models (CTMs) (
Multiple commenters expressed support for the two-tiered approach for estimating single-source secondary impacts for permit-related programs, while other commenters did not support
The EPA has issued draft guidance for use by permitting authorities and permit applicants and deferred rulemaking at this time to address how permitting authorities may develop and use significant impact levels (SILs) for ozone and PM
Specifically, the draft MERPs technical guidance provides information about how to use CTMs to estimate single-source impacts on ozone and secondary PM
The draft MERPs technical guidance
Commenters also stated that requiring chemical transport modeling as a Tier 2 demonstration tool places undue burden financially on the states, as they do not have the expertise to run or review such models, and that the regulated community does not have the expertise to run such models. Commenters requested a clearer rationale and procedure for applying CTMs for the purposes of estimating single-source secondary impacts for permit-related programs. In response, the EPA believes that its technical guidance on single-source modeling provides both the clarity necessary to conduct such modeling and the flexibility appropriate to address such situations.
First, based on peer-reviewed assessments of models used for estimating ozone and secondary PM
Second, as discussed above, the EPA expects that the use of MERPs (or a similarly credible screening approach) as a Tier 1 demonstration tool will be sufficient for most sources to satisfy their compliance demonstration. For those situations where a refined Tier 2 demonstration is necessary, the EPA has provided detailed single-source modeling guidance with clear and credible procedures for estimating single-source secondary impacts from sources doing permit related assessments. The EPA has future plans to provide a module as part of its
Multiple commenters do not agree that photochemical grid models can adequately assess single-source impacts. A commenter recognized that photochemical grid model evaluations using in-plume traverses are encouraging as documented in the IWAQM reports, but stated that more work is needed to generate additional confidence in the technique, and further requests that the EPA use newer field study data from 2013 to evaluate CTM performance against in-plume transects of ozone and secondary PM
As referenced in the preamble to the proposal, the EPA has relied upon extensive peer-reviewed literature showing that photochemical grid models have been applied for single-
Commenters requested that the EPA consider Lagrangian CTMs for use in assessing single-source secondary impacts. A commenter proposed that the Second-order Closure Integrated Puff Model (SCICHEM) can provide an alternative modeling platform for all single-source regulatory applications including ozone and secondary PM
The proposed revisions to the
The EPA is promulgating the two-tiered demonstration approach as described in section 5 of the
The EPA proposed a screening approach to address long-range transport for purposes of assessing PSD increments, its decision to remove CALPUFF as a preferred model in appendix A for such long-range transport assessments, and its decision
We received comment that there may also be certain situations where long-range transport assessments of NAAQS compliance may be necessary because either near-field NAAQS compliance is not required or the nearest receptors of concern are greater than 50 km (
Some commenters also expressed concern about the appropriateness of the EPA's technical basis for establishing the long-range transport screening assessment and, in particular, the appropriateness of the ambient levels used as benchmarks for evaluating the hypothetical source impacts. To support the EPA's proposed approach for long-range transport, we provided a TSD that demonstrated the level of single-source impacts from a variety of facility types.
A number of commenters expressed concern about the EPA's proposed removal of CALPUFF as the preferred long-range transport model in appendix A and do not support its removal without replacement. Other commenters indicated that a lack of an EPA-preferred long-range transport model increases uncertainty in performing Class I PSD increment analyses or could lead to inconsistent modeling approaches for such analyses. Also, many of these same commenters expressed concerns about the need for its approval as an alternative model and the additional time that such a process would entail.
The EPA has presented a well-reasoned and technically sound screening approach for long-range transport assessments for NAAQS and PSD increments that streamlines the time and resources necessary to conduct such analyses and provides for appropriate flexibility in the use of CALPUFF or other Lagrangian models as a screening technique. To address concerns by commenters related to the approval of CALPUFF or other Lagrangian model in this screening approach, the EPA has modified section 4.2.1 of the
Some commenters also stated that the EPA had not provided sufficient scientific or technical justification for removal of CALPUFF in appendix A, while other commenters supported the removal of CALPUFF as a preferred model. One commenter provided detailed information documenting the inconsistent nature of CALPUFF performance to more fully support the EPA's proposed action to remove it as a preferred model. As detailed in the Response to Comments document, the EPA has fully documented the past and current concerns related to the regulatory use of the CALPUFF modeling system and believes that these concerns, including the well-documented scientific and technical issues with the modeling system, support the EPA's decision to remove it as a preferred model in appendix A of the
In addition, a few commenters recommended that the EPA consider Lagrangian CTMs to address long-range transport from single sources. In this regard, some commenters mentioned the
As previously noted in the proposed rule, Phase 3 of the IWAQM process was reinitiated in June 2013 to further the EPA's commitment to update the
To inform future consideration of visibility modeling in regulatory applications consistent with the EPA's guidance for addressing chemistry for single-source impact on ozone and secondary PM
Photochemical grid models are suitable for estimating visibility and deposition since important physical and chemical processes related to the formation and transport of PM are realistically treated. Source sensitivity and apportionment techniques implemented in photochemical grid models have evolved sufficiently and provide the opportunity for estimating potential visibility and deposition impacts from one or a small group of emission sources using a full science photochemical grid model. Photochemical grid models using meteorology output from prognostic meteorological models have demonstrated skill in estimating source-receptor relationships in the near-field
Photochemical grid models have been shown to demonstrate similar skill to Lagrangian models for pollutant transport when compared to measurements made from multiple mesoscale field experiments.
As proposed, with revisions discussed above, we are taking final action to codify the screening approach to address long-range transport for purposes of assessing NAAQS and/or PSD increments; removing CALPUFF as a preferred model in appendix A for such long-range transport assessments; and confirming our recommendation to consider CALPUFF as a screening technique along with other Lagrangian models that may be used as part of this screening approach without alternative model approval. As detailed in the preamble of the proposed rule, it is important to note that the EPA's final action to remove CALPUFF as a preferred appendix A model in this
We proposed to codify our existing practice of requiring consultation and coordination between the EPA Regional Offices and the EPA's MCH on all approvals (under section 3.2.2 of the
The majority of the commenters expressed varying levels of concern with the potential for significant delay to the permit review process if all the EPA Regional Office alternative model approvals were required to seek concurrence from the MCH. Several commenters suggested that the current process, as defined in the existing
With regard to comments about possible delay to the approval process for an alternative model, it is important to point out that the revisions to the
It is important to note that the EPA's MCH has formally accepted and concurred with five alternative model requests from the EPA Regional Offices since proposal of this rule. The average MCH response time for those five requests was 28 days. There was some variability in the timing of these formal concurrences with one of the concurrences being completed within less than a day; three of the concurrences taking approximately 22 days; and one of the more complex requests taking slightly longer than 2 months. The range of MCH response times over the past year is indicative of applicants that have either engaged early with their respective EPA Regional Office through vetting of a modeling protocol and the identification and coordination of significant issues prior to submittal of their modeling compliance demonstration, or applicants that have performed a substantial amount of modeling work and justification documentation prior to any engagement with the EPA Regional Office or MCH.
When applicants do not engage with the EPA early in the process, additional time is often needed for the justification of the alternative model or options selected and/or remodeling of their facility based on issues realized through review by the EPA. In a few cases, the approach desired by an applicant had to be completely reworked from the beginning, which created significant delays in the permit review and approval process. Early engagement with the EPA will result in the shortest amount of time needed for any alternative model approval by the Agency. However, complex situations involving facilities with unique issues, and requesting a completely new or novel alternative model approach, will require additional time for the applicant, the appropriate reviewing authority, the EPA Regional Office, and the EPA's MCH to collaboratively work together through an informed and iterative process to achieve an approvable alternative model submittal. For these reasons and the recently observed response time of MCH concurrences on alternative models of less than a month, we believe that it is unwarranted to impose a regulatory time limit on the MCH concurrence process. The revised Model Clearinghouse Operational Plan outlines the MCH process by defining the roles and responsibilities of all parties, providing thorough descriptions and flow diagrams, referencing the current databases that store all formal MCH decisions, making available templates for request memoranda and other pertinent information, and providing “best practice” examples of request memoranda that highlight how to best inform the MCH process. We believe these enhancements will increase clarity and understanding of this process and make the imposition of a regulatory time limit unnecessary. This Model Clearinghouse Operational Plan is included in the docket and available on the EPA's SCRAM Web site.
The suggestion by commenters to use an external review committee for alternative model approvals is unnecessary and inappropriate. The CAA requires that air quality models are specified by the EPA Administrator. Any modification or substitution of a regulatory model under the
In this action, as proposed, we are codifying the long-standing process of the EPA Regional Offices consulting and coordinating with the MCH on all approvals of alternative models or techniques. While the Regional Administrators are the delegated authority to issue such approvals under section 3.2.2 of the
As discussed in the preamble to our proposed action, based on input from the Tenth Modeling Conference and
Many of these revisions are based on the EPA clarification memoranda issued since 2010 that were intended to provide the necessary clarification regarding applicability of the
Commenters were supportive of the addition of the definition of the modeling domain, including the appropriate factors to consider, for NAAQS and PSD increments assessments and for SIP attainment demonstrations in section 8 of the
Commenters also were supportive of the expanded discussion of receptor sites in section 9 of the
There was overwhelming support by the stakeholder community for revisions to the
In particular, there were numerous requests to further clarify the analysis of significant concentration gradients from “nearby sources,” as used in the selection of which nearby sources should be explicitly modeled in a cumulative impact assessment under PSD. In the proposed revisions to the
We received numerous comments from the stakeholder community supporting the proposed revisions to Tables 8-1 and 8-2 that allow for the modeling of nearby sources using a representation of average actual emissions based on the most recent 2 years of normal source operation. Typographical errors were noted in the public comments and have subsequently been corrected in both of these tables. The public comments also include additional recommendations for alternate procedures to develop or calculate actual emissions; however, these commenters either did not include substantive technical support for these recommendations or they were inconsistent with the required application of the preferred appendix A model.
Several commenters from the industrial sector suggested that the
A few public comments expressed concern with our recommendation of using the current monitored design value as the background ambient concentration to be included with any explicitly modeled nearby sources and the estimated modeled impact of the source for comparison to the appropriate NAAQS in PSD assessments. The concern expressed in the comments is that this practice is exceedingly conservative and results in very unrealistic characterizations of the design concentration. We agree that certain combinations of monitored background data and modeled concentrations can lead to overly conservative assessments. However, we also point out that section 8.3.2(c) of the
The modeling protocols discussion at the beginning of section 9 of the
Finally, there were a few general comments on the discussion of NAAQS and PSD increments compliance demonstrations within section 9 of the
Further, the EPA is not establishing SILs in this rulemaking and did not intend to codify the use of these values in the
As proposed, we are finalizing revisions to sections 8 and 9 of the
The EPA solicited comments on the proposed updates regarding use of meteorological input data for regulatory application of dispersion models, including the use of 2-minute Automated Surface Observing Stations (ASOS) for hourly average winds to replace standard hourly observations, and the use of prognostic meteorological data for areas where there is no representative NWS data and it is infeasible or prohibitive to collect site-specific data.
For near-field dispersion modeling applications using NWS ASOS sites, the EPA released a pre-processor to AERMET, called AERMINUTE, in 2011 that calculates hourly averaged winds from 2-minute winds reported every minute at NWS ASOS sites. AERMET substitutes these hourly averaged winds for the standard hourly observations, and thus reduces the number of calms and missing winds for input to AERMOD. The presence of calms and missing winds were due to the METAR reporting methodology of surface observations. In March 2013, the EPA released a memorandum regarding the
For a near-field dispersion modeling application where there is no representative NWS station, and it is prohibitive or not feasible to collect adequately representative site-specific data, it may be necessary to use prognostic meteorological data for the application. The EPA released the MMIF program that converts the prognostic meteorological data into a format suitable for dispersion modeling applications. The most recent 3 years of prognostic data are preferred. Use of the prognostic data are contingent on the concurrence of the appropriate reviewing authority and collaborating agencies that the data are of acceptable quality and representative of the modeling application.
We received many comments favorable to the use of prognostic meteorological data. While supporting the use of prognostic meteorological data, many commenters also requested additional guidance on running the prognostic meteorological models, assessing the suitability of the model output, and the use of MMIF to generate the meteorological data needed for AERMET and AERMOD. Based on the comments received, the EPA has updated the guidance
Therefore, as proposed, the EPA is updating the
In this action, the EPA is making editorial changes to update and reorganize information throughout the
We describe these editorial changes below for each affected section of the
As proposed, the preface is updated to reflect minor text revisions for consistency with the remainder of the
The introduction section is updated to reflect the reorganized nature of the revised
As proposed, section 2 is revised to more appropriately discuss the process by which models are evaluated and considered for use in particular applications. Information from the previous section 9 pertaining to model accuracy and uncertainty is incorporated within this section to clarify how model performance evaluation is critical in determining the suitability of models for particular application.
A discussion is provided in section 2.1 of the three types of models historically used for regulatory demonstrations. For each type of model, some strengths and weaknesses are listed to assist readers in understanding the particular regulatory applications to which they are most appropriate.
In addition, we revised section 2.2 with respect to the recommended practice of progressing from simplified and conservative air quality analysis toward more complex and refined analysis. In this section, we clarify distinctions between various types of models that have previously been described as screening models. In addition, this section clarifies distinctions between models used for screening purposes and screening techniques and demonstration tools that may be acceptable in certain applications.
A few typographical corrections were made in this section based on public comment and additional review of the proposed regulatory text. Also, based on public comment, clarity was added to the description of the modeling process to indicate that an applicant may choose to implement controls or operational limits based on screening modeling rather than performing additional refined modeling.
There were minor modifications, including a few typographical corrections, made to section 3 based on public comment to more accurately reflect current EPA practices. As proposed, the discussion of the EPA's MCH is moved to a revised section 3.3 for ease of reference and prominence within the
As proposed, section 4 is revised to incorporate the modeling approaches recommended for air quality impact analyses for the following criteria pollutants: CO, lead, SO
Section 4 now provides an in-depth discussion of screening and refined models, including the introduction of AERSCREEN as the recommended screening model for simple and complex terrain for single sources. We included a clear discussion of each appendix A preferred model in section 4.3. We modified the discussion for each preferred model (
We added a subsection specifically addressing the modeling recommendations for SO
Throughout section 4, typographical errors in our proposal were noted by commenters. We have corrected those errors and made some minor revisions for additional clarity addressing some confusion that was expressed in several public comments. Of note, modifications to the requirements discussion of section 4.2 from our proposal were made to account for the potential need for a NAAQS compliance demonstration for long-range transport situations where a near-field assessment for NAAQS is not available or indicates a significant ambient impact at or about 50 km.
As stated above, much of the previous section 5 (
Both ozone and secondary PM
While the revisions to section 5 do not specify a particular EPA-preferred model or technique for use in air quality assessments, we have established a two-tiered screening approach for ozone and secondary PM
As proposed, section 6 is revised to more clearly address the modeling recommendations of other federal agencies, such as the FLMs, that have been developed in response to EPA rules or standards. Based on public comment from a tribal association and several tribes, we have added clarifying language that indicates that other state, local, or tribal agencies with air quality and land management responsibilities may also have specific modeling approaches for their own regulatory or other requirements. While no attempt was made to comprehensively discuss each topic, we provide appropriate references to the respective federal agency guidance documents.
The revisions to section 6 focus primarily on AQRVs, including near-field and long-range transport assessments for visibility impairment and deposition. The interests of the Bureau of Ocean Energy and Management (BOEM) for Outer Continental Shelf (OCS) permitting situations and the FAA for airport and air base permitting situations are represented in section 6.3.
The discussion of Good Engineering Practices (GEP) for stack height consideration is modified and moved to section 7. We have removed the discussion of long-range transport for PSD Class I increments and the references to the previously preferred long-range transport model, CALPUFF, in accordance with the more detailed discussion in section IV.A.6 of this preamble.
As proposed, we revised section 7 to be more streamlined and appropriate to the variety of general modeling issues and considerations that are not covered in sections 4, 5, and 6 of the
We expanded the recommendations for determining rural or urban dispersion coefficients to provide more clarity with respect to appropriate characterization within AERMOD, including a discussion on the existence of highly industrialized areas where population density is low, which may be best treated with urban rather than rural dispersion coefficients. References to CALPUFF in the Complex Winds subsection have been removed in keeping with our approach to not explicitly name models that are not listed in appendix A, so as to not imply any preferential status vis-a-vis other available models. If necessary for special complex wind situations, the setup and application of an alternative model should now be determined in consultation with the appropriate reviewing authority. Finally, we revised section 7, as proposed, to include a new discussion of modeling considerations specific to mobile sources.
We made extensive updates and modifications to section 8, as proposed, to reflect current EPA practices, requirements, and recommendations for determining the appropriate modeling domain and model input data from new or modifying source(s) or sources under consideration for a revised permit limit, from background concentrations (including air quality monitoring data and nearby and others sources), and from meteorology. As with earlier sections, we modified section 8 to incorporate requirement subsections where previously section 8 ambiguously included various requirements under recommendation subheadings. Commenters identified typographical errors that have been corrected along with appropriate clarifications in this section.
The Background Concentration subsection has been significantly modified from the existing
The use of prognostic mesoscale meteorological models to provide meteorological input for regulatory dispersion modeling applications has been incorporated throughout the “Meteorological Input Data” subsection, including the introduction of the MMIF as a tool to inform regulatory model applications. We made additional minor modifications to the recommendations in this subsection based on current EPA practices, of which the most substantive edit was the recommendation to use the AERMINUTE meteorological data processor to calculate hourly average wind speed and direction when processing NWS ASOS data for developing AERMET meteorological inputs to the AERMOD dispersion model.
As proposed, we moved all of the information previously in section 9 related to model accuracy and evaluation into other sections in the revised
We revised the discussion portion of section 9 to more clearly summarize the general concepts presented in earlier sections of the
The information related to design concentrations is updated and unified from previous language found in sections 7 and 10. An expanded discussion of receptor sites is based on language from the previous section 7 and new considerations given past practices of model users tending to define an excessively large and inappropriate number of receptors based on vague guidance.
We added the recommendations for NAAQS and PSD increments compliance demonstrations that had been in section 10. In additions, we updated the recommendations to more clearly and accurately reflect the long-standing practice of performing a single-source impact analysis as a first stage of the NAAQS and PSD increments compliance demonstration and, as necessary, conducting a more comprehensive cumulative impact analysis as the second stage. The appropriate considerations and applications of screening and/or refined model are described in each stage.
Finally, we revised the “Use of Measured Data in Lieu of Model Estimates” subsection to provide more details on the process for determining the rare circumstances in which air quality monitoring data may be considered for determining the most appropriate emissions limit for a modification to an existing source. As with other portions of the revised section 9, the language throughout this subsection is updated to reflect current EPA practices, as appropriate.
As proposed, we incorporated the majority of the information found previously in section 10 into the revised section 9. Section 10 now consists of the references that were in the previous section 12. Each reference is updated, as appropriate, based on the text revisions throughout the
In a streamlining effort, we removed the bibliography section from the
As stated earlier, this references section is now section 10 with appropriate updates.
As proposed, we revised appendix A to the
This action is a significant regulatory action that was submitted to the Office of Management and Budget (OMB) for review. The OMB determined that this regulatory action could potentially interfere with an action taken or planned by another agency. Any changes made in response to OMB recommendations have been documented in the docket.
This final action does not impose an information collection burden under the PRA. This action does not contain any information collection activities, nor does it add any information collection requirements beyond those imposed by existing NSR requirements.
I certify that this action will not have a significant economic impact on a substantial number of small entities under the RFA. In making this determination, the impact of concern is any significant adverse economic impact on small entities. An agency may certify that a rule will not have a significant economic impact on a substantial number of small entities if the rule relieves regulatory burden, has no net burden or otherwise has a positive economic effect on the small entities subject to the rule.
The modeling techniques described in this action are primarily used by air agencies and by industries owning major sources subject to NSR permitting requirements. To the extent that any small entities would have to conduct air quality assessments, using the models and/or techniques described in this action are not expected to pose any additional burden on these entities. The
This action does not contain an unfunded mandate of $100 million or more as described in UMRA, 2 U.S.C. 1531-1538 and does not significantly or uniquely affect small governments. This action imposes no enforceable duty on any state, local or tribal governments or the private sector beyond those imposed by the existing NSR requirements.
This action does not have federalism implications. It will not have substantial direct effects on the states, on the relationship between the national government and the states, or on the distribution of power and responsibilities among the various levels of government.
This action does not have tribal implications, as specified in Executive Order 13175. The final rule provides revisions to the
The EPA interprets Executive Order 13045 as applying only to those regulatory actions that concern environmental health or safety risks that the EPA has reason to believe may disproportionately affect children, per the definition of “covered regulatory action” in section 2-202 of the Executive Order. This action is not subject to Executive Order 13045 because it does not concern an environmental health risk or safety risk.
This action is not a “significant energy action” as defined in Executive Order 13211 (66 FR 28355, May 22, 2001), because it is not likely to have a significant adverse effect on the supply, distribution, or use of energy. Further, we have concluded that this action is not likely to have any adverse energy effects because its purpose is to streamline the procedures by which stakeholders apply air quality modeling and technique in conducting their air quality assessments required under the CAA and, also, increases the scientific credibility and accuracy of the models and techniques used for conducting these assessments.
This rulemaking does not involve technical standards.
The EPA believes that this action is not subject to Executive Order 12898 (59 FR 7629, February 16, 1994) because it does not establish an environmental health or safety standard. This regulatory action provides updates and clarifications to the
This action is subject to the Congressional Review Act (CRA), and the EPA will submit a rule report to each House of the Congress and to the Comptroller General of the United States. This action is not a “major rule” as defined by 5 U.S.C. 804(2).
Environmental protection, Administrative practice and procedure, Air pollution control, Carbon monoxide, Intergovernmental relations, Nitrogen oxides, Ozone, Particulate matter, Reporting and recordkeeping requirements, Sulfur oxides.
For the reasons stated in the preamble, the Environmental Protection Agency is amending title 40, chapter I of the Code of Federal Regulations as follows:
23 U.S.C. 101; 42 U.S.C. 7401-7671q.
a. Industry and control agencies have long expressed a need for consistency in the application of air quality models for regulatory purposes. In the 1977 Clean Air Act (CAA), Congress mandated such consistency and encouraged the standardization of model applications. The
b. The continuing development of new air quality models in response to regulatory requirements and the expanded requirements for models to cover even more complex problems have emphasized the need for periodic review and update of guidance on these techniques. Historically, three primary activities have provided direct input to revisions of the
c. Based primarily on these three activities, new sections and topics have been included as needed. The EPA does not make changes to the guidance on a predetermined schedule, but rather on an as-needed basis. The EPA believes that revisions of the
Appendix A to Appendix W of Part 51—Summaries of Preferred Air Quality Models
a. The
b. Air quality measurements
c. It would be advantageous to categorize the various regulatory programs and to apply a designated model to each proposed source needing analysis under a given program. However, the diversity of the nation's topography and climate, and variations in source configurations and operating characteristics dictate against a strict modeling “cookbook.” There is no one model capable of properly addressing all conceivable situations even within a broad category such as point sources. Meteorological phenomena associated with threats to air quality standards are rarely amenable to a single mathematical treatment; thus, case-by-case analysis and judgment are frequently required. As modeling efforts become more complex, it is increasingly important that they be directed by highly competent individuals with a broad range of experience and knowledge in air quality
d. The model that most accurately estimates concentrations in the area of interest is always sought. However, it is clear from the needs expressed by the EPA Regional Offices, by state, local, and tribal agencies, by many industries and trade associations, and also by the deliberations of Congress, that consistency in the selection and application of models and databases should also be sought, even in case-by-case analyses. Consistency ensures that air quality control agencies and the general public have a common basis for estimating pollutant concentrations, assessing control strategies, and specifying emissions limits. Such consistency is not, however, promoted at the expense of model and database accuracy. The
e. Recommendations are made in the
f. From time to time, situations arise requiring clarification of the intent of the guidance on a specific topic. Periodic workshops are held with EPA headquarters, EPA Regional Offices, and state, local, and tribal agency modeling representatives to ensure consistency in modeling guidance and to promote the use of more accurate air quality models, techniques, and databases. The workshops serve to provide further explanations of
g. All changes to the
h. A wide range of topics on modeling and databases are discussed in the
i. Appendix W to 40 CFR part 51 contains an appendix: Appendix A. Thus, when reference is made to “appendix A” in this document, it refers to appendix A to appendix W to 40 CFR part 51. Appendix A contains summaries of refined air quality models that are “preferred” for particular applications; both EPA models and models developed by others are included.
a. Increasing reliance has been placed on concentration estimates from air quality models as the primary basis for regulatory decisions concerning source permits and emission control requirements. In many situations, such as review of a proposed new source, no practical alternative exists. Before attempting to implement the guidance contained in this document, the reader should be aware of certain general information concerning air quality models and their evaluation and use. Such information is provided in this section.
a. The extent to which a specific air quality model is suitable for the assessment of source impacts depends upon several factors. These include: (1) The topographic and meteorological complexities of the area; (2) the detail and accuracy of the input databases,
b. Air quality models are most accurate and reliable in areas that have gradual transitions of land use and topography. Meteorological conditions in these areas are spatially uniform such that observations are broadly representative and air quality model projections are not further complicated by a heterogeneous environment. Areas subject to major topographic influences experience meteorological complexities that are often difficult to measure and simulate. Models with adequate performance are available for increasingly complex environments. However, they are resource intensive and frequently require site-specific observations and formulations. Such complexities and the related challenges for the air quality simulation should be considered when selecting the most appropriate air quality model for an application.
c. Appropriate model input data should be available before an attempt is made to evaluate or apply an air quality model. Assuming the data are adequate, the greater the detail with which a model considers the spatial and temporal variations in meteorological conditions and permit-enforceable emissions, the greater the ability to evaluate the source impact and to distinguish the effects of various control strategies.
d. There are three types of models that have historically been used in the regulatory demonstrations applicable in the
i. Gaussian plume models use a “steady-state” approximation, which assumes that over the model time step, the emissions, meteorology and other model inputs, are constant throughout the model domain, resulting in a resolved plume with the emissions distributed throughout the plume according to a Gaussian distribution. This formulation allows Gaussian models to estimate near-field impacts of a limited number of sources at a relatively high resolution, with temporal scales of an hour and spatial scales of meters. However, this formulation allows for only relatively inert pollutants, with very limited considerations of transformation and removal (
ii. Lagrangian puff models, on the other hand, are non-steady-state, and assume that model input conditions are changing over the model domain and model time step. Lagrangian models can also be used to determine near- and far-field impacts from a
iii. Photochemical grid models are three-dimensional Eulerian grid-based models that treat chemical and physical processes in each grid cell and use diffusion and transport processes to move chemical species between grid cells.
e. Competent and experienced meteorologists, atmospheric scientists, and analysts are an essential prerequisite to the successful application of air quality models. The need for such specialists is critical when sophisticated models are used or the area has complicated meteorological or topographic features. It is important to note that a model applied improperly or with inappropriate data can lead to serious misjudgments regarding the source impact or the effectiveness of a control strategy.
f. The resource demands generated by use of air quality models vary widely depending on the specific application. The resources required may be important factors in the selection and use of a model or technique for a specific analysis. These resources depend on the nature of the model and its complexity, the detail of the databases, the difficulty of the application, the amount and level of expertise required, and the costs of manpower and computational facilities.
a. The formulation and application of air quality models are accompanied by several sources of uncertainty. “Irreducible” uncertainty stems from the “unknown” conditions, which may not be explicitly accounted for in the model (
b. Evaluations of model accuracy should focus on the reducible uncertainty associated with physics and the formulation of the model. The accuracy of the model is normally determined by an evaluation procedure which involves the comparison of model concentration estimates with measured air quality data.
c. Since the 1980's, the EPA has worked with the modeling community to encourage development of standardized model evaluation methods and the development of continually improved methods for the characterization of model performance.
• Scientific peer review;
• Supportive analyses (diagnostic evaluations, code verification, sensitivity analyses);
• Diagnostic and performance evaluations with data obtained in trial locations; and
• Statistical performance evaluations in the circumstances of the intended applications.
d. Performance evaluations allow the EPA and model users to determine the relative performance of a model in comparison with alternative modeling systems. Diagnostic evaluations allow determination of a model capability to simulate individual processes that affect the results, and usually employ smaller spatial/temporal scale data sets (
a. It is desirable to begin an air quality analysis by using simplified and conservative methods followed, as appropriate, by more complex and refined methods. The purpose of this approach is to streamline the process and sufficiently address regulatory requirements by eliminating the need of more detailed modeling when it is not necessary in a specific regulatory application. For example, in the context of a PSD permit application, a simplified and conservative analysis may be sufficient where it shows the proposed construction clearly will not cause or contribute to ambient concentrations in excess of either the NAAQS or the PSD increments.
b. There are two general levels of sophistication of air quality models. The first level consists of screening models that provide conservative modeled estimates of the air quality impact of a specific source or source category based on simplified assumptions of the model inputs (
c. The second level consists of refined models that provide more detailed treatment of physical and chemical atmospheric processes, require more detailed and precise input data, and provide spatially and temporally resolved concentration estimates. As a result, they provide a more sophisticated and, at least theoretically, a more accurate estimate of source impact and the effectiveness of control strategies.
d. There are situations where a screening model or a refined model is not available such that screening and refined modeling are not viable options to determine source-specific air quality impacts. In such situations, a screening technique or reduced-form model may be viable options for estimating source impacts.
i. Screening techniques are differentiated from a screening model in that screening techniques are approaches that make simplified and conservative assumptions about the physical and chemical atmospheric processes important to determining source impacts, while screening models make assumptions about conservative inputs to a specific model. The complexity of screening techniques ranges from simplified assumptions of chemistry applied to refined or screening model output to sophisticated approximations of the chemistry applied within a refined model.
ii. Reduced-form models are computationally efficient simulation tools for characterizing the pollutant response to specific types of emission reductions for a particular geographic area or background environmental conditions that reflect underlying atmospheric science of a refined model but reduce the computational resources of running a complex, numerical air quality model such as a photochemical grid model.
e. Consistent with the general principle described in paragraph 2.2(a), the EPA may establish a demonstration tool or method as a sufficient means for a user or applicant to
a. For most of the screening and refined models discussed in the
a. This section specifies the approach to be taken in determining preferred models for use in regulatory air quality programs. The status of models developed by the EPA, as well as those submitted to the EPA for review and possible inclusion in this
b. When approval is required for a specific modeling technique or analytical procedure in this
c. In all regulatory analyses, early discussions among the EPA Regional Office staff, state, local, and tribal agency staff, industry representatives, and where appropriate, the FLM, are invaluable and are strongly encouraged. Prior to the actual analyses, agreement on the databases to be used, modeling techniques to be applied, and the overall technical approach helps avoid misunderstandings concerning the final results and may reduce the later need for additional analyses. The preparation of a written modeling protocol that is vetted with the appropriate reviewing authority helps to keep misunderstandings and resource expenditures at a minimum.
d. The identification of preferred models in this
a. The EPA has developed some models suitable for regulatory application, while other models have been submitted by private developers for possible inclusion in the
b. An American Society for Testing and Materials (ASTM) reference
c. When a single model is found to perform better than others, it is recommended for application as a preferred model and listed in appendix A. If no one model is found to clearly perform better through the evaluation exercise, then the preferred model listed in appendix A may be selected on the basis of other factors such as past use, public familiarity, resource requirements, and availability. Accordingly, the models listed in appendix A meet these conditions:
i. The model must be written in a common programming language, and the executable(s) must run on a common computer platform.
ii. The model must be documented in a user's guide or model formulation report which identifies the mathematics of the model, data requirements and program operating characteristics at a level of detail comparable to that available for other recommended models in appendix A.
iii. The model must be accompanied by a complete test dataset including input parameters and output results. The test data must be packaged with the model in computer-readable form.
iv. The model must be useful to typical users,
v. The model documentation must include a robust comparison with air quality data (and/or tracer measurements) or with other well-established analytical techniques.
vi. The developer must be willing to make the model and source code available to users at reasonable cost or make them available for public access through the Internet or National Technical Information Service. The model and its code cannot be proprietary.
d. The EPA's process of establishing a preferred model includes a determination of technical merit, in accordance with the above six items, including the practicality of the model for use in ongoing regulatory programs. Each model will also be subjected to a performance evaluation for an appropriate database and to a peer scientific review. Models for wide use (not just an isolated case) that are found to perform better will be proposed for inclusion as preferred models in future
e. No further evaluation of a preferred model is required for a particular application if the EPA requirements for regulatory use specified for the model in the
a. Appendix A identifies refined models that are preferred for use in regulatory applications. If a model is required for a particular application, the user must select a model from appendix A or follow procedures in section 3.2.2 for use of an alternative model or technique. Preferred models may be used without a formal demonstration of applicability as long as they are used as indicated in each model summary in appendix A. Further recommendations for the application of preferred models to specific source applications are found in subsequent sections of the
b. If changes are made to a preferred model without affecting the modeled concentrations, the preferred status of the model is unchanged. Examples of modifications that do not affect concentrations are those made to enable use of a different computer platform or those that only affect the format or averaging time of the model results. The integration of a graphical user interface (GUI) to facilitate setting up the model inputs and/or analyzing the model results without otherwise altering the
c. A preferred model must be operated with the options listed in appendix A for its intended regulatory application. If the regulatory options are not applied, the model is no longer “preferred.” Any other modification to a preferred model that would result in a change in the concentration estimates likewise alters its status so that it is no longer a preferred model. Use of the modified model must then be justified as an alternative model on a case-by-case basis to the appropriate reviewing authority and approved by the Regional Administrator.
d. Where the EPA has not identified a preferred model for a particular pollutant or situation, the EPA may establish a multi-tiered approach for making a demonstration required under PSD or another CAA program. The initial tier or tiers may involve use of demonstration tools, screening models, screening techniques, or reduced-form models; while the last tier may involve the use of demonstration tools, refined models or techniques, or alternative models approved under section 3.2.
a. Selection of the best model or techniques for each individual air quality analysis is always encouraged, but the selection should be done in a consistent manner. A simple listing of models in this
b. This subsection discusses the use of alternate models and defines three situations when alternative models may be used. This subsection also provides a procedure for implementing 40 CFR 51.166(l)(2) in PSD permitting. This provision requires written approval of the Administrator for any modification or substitution of an applicable model. An applicable model for purposes of 40 CFR 51.166(l) is a preferred model in appendix A to the
a. Determination of acceptability of an alternative model is an EPA Regional Office responsibility in consultation with the EPA's Model Clearinghouse as discussed in paragraphs 3.0(b) and 3.2.1(b). Where the Regional Administrator finds that an alternative model is more appropriate than a preferred model, that model may be used subject to the approval of the EPA Regional Office based on the requirements of this subsection. This finding will normally result from a determination that: (1) A preferred air quality model is not appropriate for the particular application; or (2) a more appropriate model or technique is available and applicable.
b. An alternative model shall be evaluated from both a theoretical and a performance perspective before it is selected for use. There are three separate conditions under which such a model may be approved for use:
1. If a demonstration can be made that the model produces concentration estimates equivalent to the estimates obtained using a preferred model;
2. If a statistical performance evaluation has been conducted using measured air quality data and the results of that evaluation indicate the alternative model performs better for the given application than a comparable model in appendix A; or
3. If there is no preferred model.
c. Equivalency, condition (1) in paragraph (b) of this subsection, is established by demonstrating that the appropriate regulatory metric(s) are within ± 2 percent of the estimates obtained from the preferred model. The option to show equivalency is intended as a simple demonstration of acceptability for an alternative model that is nearly identical (or contains options that can make it identical) to a preferred model that it can be treated for practical purposes as the preferred model. However, notwithstanding this demonstration, models that are not equivalent may be used when one of the two other conditions described in paragraphs (d) and (e) of this subsection are satisfied.
d. For condition (2) in paragraph (b) of this subsection, established statistical performance evaluation procedures and techniques
e. Finally, for condition (3) in paragraph (b) of this subsection, an alternative model or technique may be approved for use provided that:
i. The model or technique has received a scientific peer review;
ii. The model or technique can be demonstrated to be applicable to the problem on a theoretical basis;
iii. The databases which are necessary to perform the analysis are available and adequate;
iv. Appropriate performance evaluations of the model or technique have shown that the model or technique is not inappropriately biased for regulatory application
v. A protocol on methods and procedures to be followed has been established.
f. To formally document that the requirements of section 3.2 for use of an alternative model are satisfied for a particular application or range of applications, a memorandum will be prepared by the EPA's Model Clearinghouse through a consultative process with the EPA Regional Office.
a. The Regional Administrator has the authority to select models that are appropriate for use in a given situation. However, there is a need for assistance and guidance in the selection process so that fairness, consistency, and transparency in modeling decisions are fostered among the EPA Regional Offices and the state, local, and tribal agencies. To satisfy that need, the EPA established the Model Clearinghouse
b. The appropriate EPA Regional Office should always be consulted for information and guidance concerning modeling methods and interpretations of modeling guidance, and to ensure that the air quality model user has available the latest most up-to-date policy and procedures. As appropriate, the EPA Regional Office may also request assistance from the EPA's Model Clearinghouse on other applications of models, analytical techniques, or databases or to clarify interpretation of the
c. The EPA Regional Office will coordinate with the EPA's Model Clearinghouse after an initial evaluation and decision has been developed concerning the application of an alternative model. The acceptability and formal approval process for an alternative model is described in section 3.2.
a. This section identifies modeling approaches generally used in the air quality impact analysis of sources that emit the criteria pollutants carbon monoxide (CO), lead, sulfur dioxide (SO
b. The guidance in this section is specific to the application of the Gaussian plume models identified in appendix A. Gaussian plume models assume that emissions and meteorology are in a steady-state, which is typically based on an hourly time step. This approach results in a plume that has an hourly-averaged distribution of emission mass according to a Gaussian curve through the plume. Though Gaussian steady-state models conserve the mass of the primary pollutant throughout the plume, they can still take into account a limited consideration of first-order removal processes (
c. Due to the steady-state assumption, Gaussian plume models are generally considered applicable to distances less than 50 km, beyond which, modeled predictions of plume impact are likely conservative. The locations of these impacts are expected to be unreliable due to changes in meteorology that are likely to occur during the travel time.
d. The applicability of Gaussian plume models may vary depending on the topography of the modeling domain,
e. Gaussian models determine source impacts at discrete locations (receptors) for each meteorological and emission scenario, and generally attempt to estimate concentrations at specific sites that represent an ensemble average of numerous repetitions of the same “event.” Uncertainties in model estimates are driven by this formulation, and as noted in section 2.1.1, evaluations of model accuracy should focus on the reducible uncertainty associated with physics and the formulation of the model. The “irreducible” uncertainty associated with Gaussian plume models may be responsible for variation in concentrations of as much as ± 50 percent.
f. Model evaluations and inter-comparisons should take these aspects of uncertainty into account. For a regulatory application of a model, the emphasis of model evaluations is generally placed on the highest modeled impacts. Thus, the Cox-Tikvart model evaluation approach, which compares the highest modeled impacts on several timescales, is recommended for comparisons of models and measurements and model inter-comparisons. The approach includes bootstrap techniques to determine the significance of various modeled predictions and increases the robustness of such comparisons when the number of available measurements are limited.
a. For NAAQS compliance demonstrations under PSD, use of the screening and preferred models for the pollutants listed in this subsection shall be limited to the near-field at a nominal distance of 50 km or less. Near-field application is consistent with capabilities of Gaussian plume models and, based on the EPA's assessment, is sufficient to address whether a source will cause or contribute to ambient concentrations in excess of a NAAQS. In most cases, maximum source impacts of inert pollutants will occur within the first 10 to 20 km from the source. Therefore, the EPA does not consider a long-range transport assessment beyond 50 km necessary for these pollutants if a near-field NAAQS compliance demonstration is required.
b. For assessment of PSD increments within the near-field distance of 50 km or less, use of the screening and preferred models for the pollutants listed in this subsection shall be limited to the same screening and preferred models approved for NAAQS compliance demonstrations.
c. To determine if a compliance demonstration for NAAQS and/or PSD increments may be necessary beyond 50 km (
i. Based on application in the near-field of the appropriate screening and/or preferred model, determine the significance of the ambient impacts at or about 50 km from the new or modifying source. If a near-field assessment is not available or this initial analysis indicates there may be significant ambient impacts at that distance, then further assessment is necessary.
ii. For assessment of the significance of ambient impacts for NAAQS and/or PSD increments, there is not a preferred model or screening approach for distances beyond 50 km. Thus, the appropriate reviewing authority (paragraph 3.0(b)) and the EPA Regional Office shall be consulted in determining the appropriate and agreed upon screening technique to conduct the second level assessment. Typically, a Lagrangian model is most appropriate to use for these second level assessments, but applicants shall reach agreement on the specific model and modeling parameters on a case-by-case basis in consultation with the appropriate reviewing authority (paragraph 3.0(b)) and EPA Regional Office. When Lagrangian models are used in this manner, they shall not include plume-depleting processes, such that model estimates are considered conservative, as is generally appropriate for screening assessments.
d. In those situations where a cumulative impact analysis for NAAQS and/or PSD increments analysis beyond 50 km is necessary, the selection and use of an alternative model shall occur in agreement with the appropriate reviewing authority (paragraph 3.0(b)) and approval by the EPA Regional Office based on the requirements of paragraph 3.2.2(e).
a. Where a preliminary or conservative estimate is desired, point source screening techniques are an acceptable approach to air quality analyses.
b. As discussed in paragraph 2.2(a), screening models or techniques are designed to provide a conservative estimate of concentrations. The screening models used in most applications are the screening versions of the preferred models for refined applications. The two screening models, AERSCREEN
c. Although AERSCREEN and CTSCREEN are designed to address a single-source scenario, there are approaches that can be used on a case-by-case basis to address multi-source situations using screening meteorology or other conservative model assumptions. However, the appropriate reviewing authority (paragraph 3.0(b)) shall be consulted, and concurrence obtained, on the protocol for modeling multiple sources with AERSCREEN or CTSCREEN to ensure that the worst case is identified and assessed.
d. As discussed in section 4.2.3.4, there are also screening techniques built into AERMOD that use simplified or limited chemistry assumptions for determining the partitioning of NO and NO
e. As discussed in section 4.2(c)(ii), there are screening techniques needed for long-range transport assessments that will typically involve the use of a Lagrangian model. Based on the long-standing practice and documented capabilities of these models for long-range transport assessments, the use of a Lagrangian model as a screening technique for this purpose does not need to be approved as an alternative model. However, their usage shall occur in consultation with the appropriate reviewing authority (paragraph 3.0(b)) and EPA Regional Office.
f. All screening models and techniques shall be configured to appropriately address the site and problem at hand. Close attention must be paid to whether the area should be classified urban or rural in accordance with section 7.2.1.1. The climatology of the area must be studied to help define the worst-case meteorological conditions. Agreement shall be reached between the model user and the appropriate reviewing authority (paragraph 3.0(b)) on the choice of the screening model or technique for each analysis, on the input data and model settings, and the appropriate metric for satisfying regulatory requirements.
a. Released in 2011, AERSCREEN is the EPA's recommended screening model for simple and complex terrain for single sources including point sources, area sources, horizontal stacks, capped stacks, and flares. AERSCREEN runs AERMOD in a screening mode and consists of two main components: 1) the MAKEMET program which generates a site-specific matrix of meteorological conditions for input to the AERMOD model; and 2) the AERSCREEN command-prompt interface.
b. The MAKEMET program generates a matrix of meteorological conditions, in the form of AERMOD-ready surface and profile files, based on user-specified surface characteristics, ambient temperatures, minimum wind speed, and anemometer height. The meteorological matrix is generated based on looping through a range of wind speeds, cloud covers, ambient temperatures, solar elevation angles, and convective velocity scales (w*, for convective conditions only) based on user-specified surface characteristics for surface roughness (Z
c. For applications involving simple or complex terrain, AERSCREEN interfaces with AERMAP. AERSCREEN also interfaces with BPIPPRM to provide the necessary building parameters for applications involving building downwash using the Plume Rise Model Enhancements (PRIME) downwash algorithm. AERSCREEN generates inputs to AERMOD via MAKEMET, AERMAP, and BPIPPRM and invokes AERMOD in a screening mode. The screening mode of AERMOD forces the AERMOD model calculations to represent values for the plume centerline, regardless of the source-receptor-wind direction orientation. The maximum concentration output from AERSCREEN represents a worst-case 1-hour concentration. Averaging-time scaling factors of 1.0 for 3-hour, 0.9 for 8-hour, 0.60 for 24-hour, and 0.10 for annual concentration averages are applied internally by AERSCREEN to the highest 1-hour concentration calculated by the model for non-area type sources. For area type source concentrations for averaging times greater than one hour, the concentrations are equal to the 1-hour estimates.
a. CTSCREEN
a. For applications utilizing AERSCREEN, AERSCREEN automatically generates a polar-grid receptor network with spacing determined by the maximum distance to model. If the application warrants a different receptor network than that generated by AERSCREEN, it may be necessary to run AERMOD in screening mode with a user-defined network. For CTSCREEN applications or AERMOD in screening mode outside of AERSCREEN, placement of receptors requires very careful attention when modeling in complex terrain. Often the highest concentrations are predicted to occur under very stable conditions, when the plume is near or impinges on the terrain. Under such conditions, the plume may be quite narrow in the vertical, so that even relatively small changes in a receptor's location may substantially affect the predicted concentration. Receptors within about a kilometer of the source may be even more sensitive to location. Thus, a dense array of receptors may be required in some cases.
b. For applications involving AERSCREEN, AERSCREEN interfaces with AERMAP to generate the receptor elevations. For applications involving CTSCREEN, digitized contour data must be preprocessed
c. Other screening techniques may be acceptable for complex terrain cases where established procedures
a. A brief description of each preferred model for refined applications is found in appendix A. Also listed in that appendix are availability, the model input requirements, the standard options that shall be selected when running the program, and output options.
a. For a wide range of regulatory applications in all types of terrain, and for aerodynamic building downwash, the required model is AERMOD.
b. The AERMOD modeling system has been extensively evaluated across a wide range of scenarios based on numerous field studies, including tall stacks in flat and complex terrain settings, sources subject to building downwash influences, and low-level non-buoyant sources.
c. AERMOD incorporates the PRIME algorithm to account for enhanced plume growth and restricted plume rise for plumes affected by building wake effects.
d. AERMOD incorporates the Buoyant Line and Point Source (BLP) Dispersion model to account for buoyant plume rise from line sources. The BLP option utilizes the standard meteorological inputs provided by the AERMET meteorological processor.
e. The state-of-the-science for modeling atmospheric deposition is evolving, new modeling techniques are continually being assessed, and their results are being compared with observations. Consequently, while deposition treatment is available in AERMOD, the approach taken for any purpose shall be coordinated with the appropriate reviewing authority (paragraph 3.0(b)).
a. If the modeling application involves an elevated point source with a well-defined hill or ridge and a detailed dispersion analysis of the spatial pattern of plume impacts is of interest, CTDMPLUS is available. CTDMPLUS provides greater resolution of concentrations about the contour of the hill feature than does AERMOD through a different plume-terrain interaction algorithm.
a. If the modeling application involves determining the impact of offshore emissions from point, area, or line sources on the air quality of coastal regions, the recommended model is the OCD (Offshore and Coastal Dispersion) Model. OCD is a straight-line Gaussian model that incorporates overwater plume transport and dispersion as well as changes that occur as the plume crosses the shoreline. OCD is also applicable for situations that involve platform building downwash.
a. Models for assessing the impact of CO emissions are needed to meet NSR requirements to address compliance with the CO NAAQS and to determine localized impacts from transportations projects. Examples include evaluating effects of point sources, congested roadway intersections and highways, as well as the cumulative effect of numerous sources of CO in an urban area.
b. The general modeling recommendations and requirements for screening models in section 4.2.1 and refined models in section 4.2.2 shall be applied for CO modeling. Given the relatively low CO background concentrations, screening techniques are likely to be adequate in most cases. In applying these recommendations and requirements, the existing 1992 EPA guidance for screening CO impacts from highways may be consulted.
a. In January 1999 (40 CFR part 58, appendix D), the EPA gave notice that concern about ambient lead impacts was being shifted away from roadways and toward a focus on stationary point sources. Thus, models for assessing the impact of lead emissions are needed to meet NSR requirements to address compliance with the lead NAAQS and for SIP attainment demonstrations. The EPA has also issued guidance on siting ambient monitors in the vicinity of stationary point sources.
b. For major lead point sources, such as smelters, which contribute fugitive emissions and for which deposition is important, professional judgment should be used, and there shall be coordination with the appropriate reviewing authority (paragraph 3.0(b)). For most applications, the general requirements for screening and refined models of section 4.2.1 and 4.2.2 are applicable to lead modeling.
a. Models for SO
b. Given the relatively inert nature of SO
a. Models for assessing the impact of sources on ambient NO
b. Due to the complexity of NO
i. A first-tier (most conservative) “full” conversion approach;
ii. A second-tier approach that assumes ambient equilibrium between NO and NO
iii. A third-tier consisting of several detailed screening techniques that account for ambient ozone and the relative amount of NO and NO
c. For Tier 1, use an appropriate refined model (section 4.2.2) to estimate nitrogen oxides (NO
d. For Tier 2, multiply the Tier 1 result(s) by the Ambient Ratio Method 2 (ARM2), which provides estimates of representative equilibrium ratios of NO
e. For Tier 3, a detailed screening technique shall be applied on a case-by-case basis. Because of the additional input data requirements and complexities associated with the Tier 3 options, their usage shall occur in consultation with the EPA Regional Office in addition to the appropriate reviewing authority. The Ozone Limiting Method (OLM)
f. Alternative models or techniques may be considered on a case-by-case basis and their usage shall be approved by the EPA Regional Office (section 3.2). Such models or
a. PM
b. For NSR modeling assessments, the general modeling requirements for screening models in section 4.2.1 and refined models in section 4.2.2 are applicable for the primary component of PM
c. For SIP attainment demonstrations and regional haze reasonable progress goal analyses, effects of a control strategy on PM
d. The general modeling requirements for the refined models discussed in section 4.2.2 shall be applied for PM
a. Models for PM
b. For most sources, the general modeling requirements for screening models in section 4.2.1 and refined models in section 4.2.2 shall be applied for PM
c. Fugitive dust usually refers to dust put into the atmosphere by the wind blowing over plowed fields, dirt roads, or desert or sandy areas with little or no vegetation. Fugitive emissions include the emissions resulting from the industrial process that are not captured and vented through a stack, but may be released from various locations within the complex. In some unique cases, a model developed specifically for the situation may be needed. Due to the difficult nature of characterizing and modeling fugitive dust and fugitive emissions, the proposed procedure shall be determined in consultation with the appropriate reviewing authority (paragraph 3.0(b)) for each specific situation before the modeling exercise is begun. Re-entrained dust is created by vehicles driving over dirt roads (
d. Under certain conditions, recommended dispersion models may not be suitable to appropriately address the nature of ambient PM
e. The general modeling requirements for the refined models discussed in section 4.2.2 shall be applied for PM
a. Air pollutants formed through chemical reactions in the atmosphere are referred to as secondary pollutants. For example, ground-level ozone and a portion of PM
b. Ozone formation is driven by emissions of NO
c. PM
d. Control measures reducing ozone and PM
e. PM
a. Chemical transformations can play an important role in defining the concentrations and properties of certain air pollutants. Models that take into account chemical reactions and physical processes of various pollutants (including precursors) are needed for determining the current state of air quality, as well as predicting and projecting the future evolution of these pollutants. It is important that a modeling system provide a realistic representation of chemical and physical processes leading to secondary pollutant formation and removal from the atmosphere.
b. Chemical transport models treat atmospheric chemical and physical processes such as deposition and motion. There are two types of chemical transport models, Eulerian (grid based) and Lagrangian. These types of models are differentiated from each other by their frame of reference. Eulerian models are based on a fixed frame of reference and Lagrangian models use a frame of reference that moves with parcels of air between the source and receptor point.
c. Regardless of the modeling system used to estimate secondary impacts of ozone and/or PM
d. Model performance metrics comparing observations and predictions are often used to summarize model performance. These metrics include mean bias, mean error, fractional bias, fractional error, and correlation coefficient.
e. There is no preferred modeling system or technique for estimating ozone or secondary PM
a. Models that estimate ozone concentrations are needed to guide the choice of strategies for the purposes of a nonattainment area demonstrating future year attainment of the ozone NAAQS. Additionally, models that estimate ozone concentrations are needed to assess impacts from specific sources or source complexes to satisfy requirements for NSR and other regulatory programs. Other purposes for ozone modeling include estimating the impacts of specific events on air quality, ozone deposition impacts, and planning for areas that may be attaining the ozone NAAQS.
a. Simulation of ozone formation and transport is a complex exercise. Control agencies with jurisdiction over areas with ozone problems should use photochemical grid models to evaluate the relationship between precursor species and ozone. Use of photochemical grid models is the recommended means for identifying control strategies needed to address high ozone concentrations in such areas. Judgment on the suitability of a model for a given application should consider factors that include use of the model in an attainment test, development of emissions and meteorological inputs to the model, and choice of episodes to model. Guidance on the use of models and other analyses for demonstrating attainment of the air quality goals for ozone is available.
a. Depending on the magnitude of emissions, estimating the impact of an individual source's emissions of NO
b. The first tier of assessment for ozone impacts involves those situations where existing technical information is available (
c. The second tier of assessment for ozone impacts involves those situations where existing technical information is not available or a first tier demonstration indicates a more refined assessment is needed. For these situations, chemical transport models should be used to address single-source impacts. Special considerations are needed when using these models to evaluate the ozone impact from an individual source. Guidance on the use of models and other analyses for demonstrating the impacts of single sources for ozone is available.
a. Models that estimate PM
a. Models for PM
a. Depending on the magnitude of emissions, estimating the impact of an individual source's emissions on secondary particulate matter concentrations may be necessary for obtaining a permit. Primary PM
b. The first tier of assessment for secondary PM
c. The second tier of assessment for secondary PM
a. Other federal government agencies and state, local, and tribal agencies with air quality and land management responsibilities have also developed specific modeling approaches for their own regulatory or other requirements. Although such regulatory requirements and guidance have come about because of EPA rules or standards, the implementation of such regulations and the use of the modeling techniques is under the jurisdiction of the agency issuing the guidance or directive. This section covers such situations with reference to those guidance documents, when they are available.
b. When using the model recommended or discussed in the
a. The 1990 CAA Amendments give FLMs an “affirmative responsibility” to protect the natural and cultural resources of Class I areas from the adverse impacts of air pollution and to provide the appropriate procedures and analysis techniques. The CAA identifies the FLM as the Secretary of the department, or their designee, with authority over these lands. Mandatory Federal Class I areas are defined in the CAA as international parks, national parks over 6,000 acres, and wilderness areas and memorial parks over 5,000 acres, established as of 1977. The FLMs are also concerned with the protection of resources in federally managed Class II areas because of other statutory mandates to protect these areas. Where state or tribal agencies have successfully petitioned the EPA and lands have been redesignated to Class I status, these agencies may have equivalent responsibilities to that of the FLMs for these non-federal Class I areas as described throughout the remainder of section 6.2.
b. The FLM agency responsibilities include the review of air quality permit applications from proposed new or modified major pollution sources that may affect these Class I areas to determine if emissions from a proposed or modified source will cause or contribute to adverse impacts on air quality related values (AQRVs) of a Class I area and making recommendations to the FLM. AQRVs are resources, identified by the FLM agencies, that have the potential to be affected by air pollution. These resources may include visibility, scenic, cultural, physical, or ecological resources for a particular area. The FLM agencies take into account the particular resources and AQRVs that would be affected; the frequency and magnitude of any potential impacts; and the direct, indirect, and cumulative effects of any potential impacts in making their recommendations.
c. While the AQRV notification and impact analysis requirements are outlined in the PSD regulations at 40 CFR 51.166(p) and 40 CFR 52.21(p), determination of appropriate analytical methods and metrics for AQRV's are determined by the FLM agencies and are published in guidance external to the general recommendations of this paragraph.
d. To develop greater consistency in the application of air quality models to assess potential AQRV impacts in both Class I areas and protected Class II areas, the FLM agencies have developed the Federal Land Managers' Air Quality Related Values Work Group Phase I Report (FLAG).
a. Visibility in important natural areas (
b. Visibility regulations (40 CFR 51.300 through 51.309) require state, local, and tribal agencies to mitigate current and prevent future visibility impairment in any of the 156 mandatory Federal Class I areas where visibility is considered an important attribute. In 1999, the EPA issued revisions to the regulations to address visibility impairment in the form of regional haze, which is caused by numerous, diverse sources (
c. The FLAG visibility modeling recommendations are divided into two distinct sections to address different requirements for: (1) Near field modeling where plumes or layers are compared against a viewing background, and (2) distant/multi-source modeling for plumes and aggregations of plumes that affect the general appearance of a scene.
a. To calculate the potential impact of a plume of specified emissions for specific transport and dispersion conditions (“plume blight”) for source-receptor distances less than 50 km, a screening model and guidance are available.
a. Chemical transformations can play an important role in defining the concentrations and properties of certain air pollutants. Models that take into account chemical reactions and physical processes of various pollutants (including precursors) are needed for determining the current state of air quality, as well as predicting and projecting the future evolution of these pollutants. It is important that a modeling system provide a realistic representation of chemical and physical processes leading to secondary pollutant formation and removal from the atmosphere.
b. Chemical transport models treat atmospheric chemical and physical processes such as deposition and motion. There are two types of chemical transport models, Eulerian (grid based) and Lagrangian. These types of models are differentiated from each other by their frame of reference. Eulerian models are based on a fixed frame of reference and Lagrangian models use a frame of reference that moves with parcels of air between the source and receptor point.
c. Development of the requisite meteorological and emissions databases necessary for use of photochemical grid models to estimate AQRVs should conform to recommendations in section 8 and those outlined in the EPA's
a. For many Class I areas, AQRVs have been identified that are sensitive to atmospheric deposition of air pollutants. Emissions of NO
b. The FLM deposition modeling recommendations are divided into two distinct sections to address different requirements for: (1) Near field modeling, and (2) distant/multi-source modeling for cumulative effects. The recommendations separately address deposition assessments for sources proposing to locate relatively near and at farther distances from these areas.
a. Dispersion and photochemical grid modeling may need to be conducted to ensure that individual and cumulative offshore oil and gas exploration, development, and production plans and activities do not significantly affect the air quality of any state as required under the Outer Continental Shelf Lands Act (OCSLA). Air quality modeling requires various input datasets, including emissions sources, meteorology, and pre-existing pollutant concentrations. For sources under the reviewing authority of the Department of Interior, Bureau of Ocean Energy Management (BOEM), guidance for the development of all necessary Outer Continental Shelf (OCS) air quality modeling inputs and appropriate model selection and application is available from the BOEM's Web site:
b. The Federal Aviation Administration (FAA) is the appropriate reviewing authority for air quality assessments of primary pollutant impacts at airports and air bases. The Aviation Environmental Design Tool (AEDT) is developed and supported by the FAA, and is appropriate for air quality assessment of primary pollutant impacts at airports or air bases. AEDT has adopted AERMOD for treating dispersion. Application of AEDT is intended for estimating the change in emissions for aircraft operations, point source, and mobile source emissions on airport property and quantify the associated pollutant level- concentrations. AEDT is not intended for PSD, SIP, or other regulatory air quality analyses of point or mobile sources at or peripheral to airport property that are unrelated to airport operations. The latest version of AEDT may be obtained from the FAA at:
a. This section contains recommendations concerning a number of different issues not explicitly covered in other sections of the
a. For any dispersion modeling exercise, the urban or rural determination of a source is critical in determining the boundary layer characteristics that affect the model's prediction of downwind concentrations. Historically, steady-state Gaussian plume models used in most applications have employed dispersion coefficients based on Pasquill-Gifford
b. The selection of rural or urban dispersion coefficients in a specific application should follow one of the procedures suggested by Irwin
i. Land Use Procedure: (1) Classify the land use within the total area, A
ii. Population Density Procedure: (1) Compute the average population density, p
c. Population density should be used with caution and generally not be applied to highly industrialized areas where the population density may be low and, thus, a rural classification would be indicated. However, the area is likely to be sufficiently built-up so that the urban land use criteria would be satisfied. Therefore, in this case, the classification should be “urban” and urban dispersion parameters should be used.
d. For applications of AERMOD in urban areas, under either the Land Use Procedure or the Population Density Procedure, the user needs to estimate the population of the urban area affecting the modeling domain because the urban influence in AERMOD is scaled based on a user-specified population. For non-population oriented urban areas, or areas influenced by both population and industrial activity, the user will need to estimate an equivalent population to adequately account for the combined effects of industrialized areas and populated areas within the modeling domain. Selection of the appropriate population for these applications should be determined in consultation with the appropriate reviewing authority (paragraph 3.0(b)) and the latest version of the AERMOD Implementation Guide.
e. It should be noted that AERMOD allows for modeling rural and urban sources in a single model run. For analyses of whole urban complexes, the entire area should be modeled as an urban region if most of the sources are located in areas classified as urban. For tall stacks located within or adjacent to small or moderate sized urban areas, the stack height or effective plume height may extend above the urban boundary layer and, therefore, may be more appropriately modeled using rural coefficients. Model users should consult with the appropriate reviewing authority (paragraph 3.0(b)) and the latest version of the AERMOD Implementation Guide
f. Buoyancy-induced dispersion (BID), as identified by Pasquill,
a.
i.
ii.
iii.
a. Gravitational settling and deposition may be directly included in a model if either is a significant factor. When particulate matter sources can be quantified and settling and dry deposition are problems, use professional judgment along with coordination with the appropriate reviewing authority (paragraph 3.0(b)). AERMOD contains algorithms for dry and wet deposition of gases and particles.
a. The use of stack height credit in excess of Good Engineering Practice (GEP) stack height or credit resulting from any other dispersion technique is prohibited in the development of emissions limits by 40 CFR 51.118 and 40 CFR 51.164. The definition of GEP stack height and dispersion technique are contained in 40 CFR 51.100. Methods and procedures for making the appropriate stack height calculations, determining stack height credits and an example of applying those techniques are found in several references,
b. If stacks for new or existing major sources are found to be less than the height defined by the EPA's refined formula for determining GEP height, then air quality impacts associated with cavity or wake effects due to the nearby building structures should be determined. The EPA refined formula height is defined as H + 1.5L.
a. The plume rise methods of Briggs
b. Gradual plume rise is generally recommended where its use is appropriate: (1) In AERMOD; (2) in complex terrain screening procedures to determine close-in impacts; and (3) when calculating the effects of building wakes. The building wake algorithm in AERMOD incorporates and exercises the thermodynamically based gradual plume rise calculations as described in paragraph (a) of this subsection. If the building wake is calculated to affect the plume for any hour, gradual plume rise is also used in downwind dispersion calculations to the distance of final plume rise, after which final plume rise is used. Plumes captured by the near wake are re-emitted to the far wake as a ground-level volume source.
c. Stack tip downwash generally occurs with poorly constructed stacks and when the ratio of the stack exit velocity to wind speed is small. An algorithm developed by Briggs
d. On a case-by-case basis, refinements to the preferred model may be considered for plume rise and downwash effects and shall occur in agreement with the appropriate reviewing authority (paragraph 3.0(b)) and approval by the EPA Regional Office based on the requirements of section 3.2.2.
a. Emissions of primary pollutants from mobile sources can be modeled with an appropriate model identified in section 4.2. Screening of mobile sources can be accomplished by using screening meteorology,
b. Mobile sources can be modeled in AERMOD as either line (
c. The EPA's quantitative PM hot-spot guidance
a. Databases and related procedures for estimating input parameters are an integral part of the modeling process. The most appropriate input data available should always be selected for use in modeling analyses. Modeled concentrations can vary widely depending on the source data or meteorological data used. This section attempts to minimize the uncertainty associated with database selection and use by identifying requirements for input data used in modeling. More specific data requirements and the format required for the individual models are described in detail in the user's guide and/or associated documentation for each model.
a. The modeling domain is the geographic area for which the required air quality analyses for the NAAQS and PSD increments are conducted.
a. For a NAAQS or PSD increments assessment, the modeling domain or project's impact area shall include all locations where the emissions of a pollutant from the new or modifying source(s) may cause a significant ambient impact. This impact area is defined as an area with a radius extending from the new or modifying source to: (1) The most distant location where air quality modeling predicts a significant ambient impact will occur, or (2) the nominal 50 km distance considered applicable for Gaussian dispersion models, whichever is less. The required air quality analysis shall be carried out within this geographical area with characterization of source impacts, nearby source impacts, and background concentrations, as recommended later in this section.
b. For SIP attainment demonstrations for ozone and PM
a. Sources of pollutants can be classified as point, line, area, and volume sources. Point sources are defined in terms of size and may vary between regulatory programs. The line sources most frequently considered are roadways and streets along which there are well-defined movements of motor vehicles. They may also be lines of roof vents or stacks, such as in aluminum refineries. Area and volume sources are often collections of a multitude of minor sources with individually small emissions that are impractical to consider as separate point or line sources. Large area sources are typically treated as a grid network of square areas, with pollutant emissions distributed uniformly within each grid square. Generally, input data requirements for air quality models necessitate the use of metric units. As necessary, any English units common to engineering applications should be appropriately converted to metric.
b. For point sources, there are many source characteristics and operating conditions that may be needed to appropriately model the facility. For example, the plant layout (
c. Modeling mobile emissions from streets and highways requires data on the road layout, including the width of each traveled lane, the number of lanes, and the width of the median strip. Additionally, traffic patterns should be taken into account (
d. Emission factors can be determined through source-specific testing and measurements (
a. For SIP attainment demonstrations for the purpose of projecting future year NAAQS attainment for ozone, PM
b. For the purpose of SIP revisions for stationary point sources, the regulatory modeling of inert pollutants shall use the emissions input data shown in Table 8-1 for short-term and long-term NAAQS. To demonstrate compliance and/or establish the appropriate SIP emissions limits, Table 8-1 generally provides for the use of “allowable” emissions in the regulatory dispersion modeling of the stationary point source(s) of interest. In such modeling, these source(s) should be modeled sequentially with these loads for every hour of the year. As part of a cumulative impact analysis, Table 8-1 allows for the model user to account for actual operations in developing the emissions inputs for dispersion modeling of nearby sources, while other sources are best represented by air quality monitoring data. Consultation with the appropriate reviewing authority (paragraph 3.0(b)) is advisable on the establishment of the appropriate emissions inputs for regulatory modeling applications with respect to SIP revisions for stationary point sources.
c. For the purposes of demonstrating NAAQS compliance in a PSD assessment, the regulatory modeling of inert pollutants shall use the emissions input data shown in Table 8-2 for short and long-term NAAQS. The new or modifying stationary point source shall be modeled with “allowable” emissions in the regulatory dispersion modeling. As part of a cumulative impact analysis, Table 8-2 allows for the model user to account for actual operations in developing the emissions inputs for dispersion modeling of nearby sources, while other sources are best represented by air quality monitoring data. For purposes of situations involving emissions trading, refer to current EPA policy and guidance to establish input data. Consultation with the appropriate reviewing authority (paragraph 3.0(b)) is advisable on the establishment of the appropriate emissions inputs for regulatory modeling applications with respect to PSD assessments for a proposed new or modifying source.
d. For stationary source applications, changes in operating conditions that affect the physical emission parameters (
e. Emissions from mobile sources also have physical and temporal characteristics that should be appropriately accounted. For example, an appropriate emissions model shall be used to determine emissions profiles. Such emissions should include speciation specific for the vehicle types used on the roadway (
a. Background concentrations are essential in constructing the design concentration, or total air quality concentration, as part of a cumulative impact analysis for NAAQS and PSD increments (section 9.2.3). Background air quality should not include the ambient impacts of the project source under consideration. Instead, it should include:
i. Nearby sources: These are individual sources located in the vicinity of the source(s) under consideration for emissions limits that are not adequately represented by ambient monitoring data. Typically, sources that cause a significant concentration gradient in the vicinity of the source(s) under consideration for emissions limits are not adequately represented by background ambient monitoring. The ambient contributions from these nearby sources are thereby accounted for by explicitly modeling their emissions (section 8.2).
ii. Other sources: That portion of the background attributable to natural sources, other unidentified sources in the vicinity of the project, and regional transport contributions from more distant sources (domestic and international). The ambient contributions from these sources are typically accounted for through use of ambient monitoring data or, in some cases, regional-scale photochemical grid modeling results.
b. The monitoring network used for developing background concentrations is expected to conform to the same quality assurance and other requirements as those networks established for PSD purposes.
c. For photochemical grid modeling conducted in SIP attainment demonstrations for ozone, PM
d. For NAAQS assessments and SIP attainment demonstrations for inert pollutants, the development of the appropriate background concentration for a cumulative impact analysis involves proper accounting of each contribution to the design concentration and will depend upon whether the project area's situation consists of either an isolated single source(s) or a multitude of sources. For PSD increment assessments, all impacts after the appropriate baseline dates (
a. In areas with an isolated source(s), determining the appropriate background concentration should focus on characterization of contributions from all other sources through adequately representative ambient monitoring data.
b. The EPA recommends use of the most recent quality assured air quality monitoring data collected in the vicinity of the source to determine the background concentration for the averaging times of concern. In most cases, the EPA recommends using data from the monitor closest to and upwind of the project area. If several monitors are available, preference should be given to the monitor with characteristics that are most similar to the project area. If there are no monitors located in the vicinity of the new or modifying source, a “regional site” may be used to determine background concentrations. A regional site is one that is located away from the area of interest but is impacted by similar or adequately representative sources.
c. Many of the challenges related to cumulative impact analyses arise in the context of defining the appropriate metric to characterize background concentrations from ambient monitoring data and determining the appropriate method for combining this monitor-based background contribution to the modeled impact of the project and other nearby sources. For many cases, the best starting point would be use of the current design value for the applicable NAAQS as a uniform monitored background contribution across the project area. However, there are cases in which the current design value may not be appropriate. Such cases include but are not limited to:
i. For situations involving a modifying source where the existing facility is determined to impact the ambient monitor, the background concentration at each monitor can be determined by excluding values when the source in question is impacting the monitor. In such cases, monitoring sites inside a 90° sector downwind of the source may be used to determine the area of impact.
ii. There may be other circumstances which would necessitate modifications to the ambient data record. Such cases could include removal of data from specific days or hours when a monitor is being impacted by activities that are not typical or not expected to occur again in the future (
iii. For short-term standards, the diurnal or seasonal patterns of the air quality monitoring data may differ significantly from the patterns associated with the modeled concentrations. When this occurs, it may be appropriate to pair the air quality monitoring data in a temporal manner that reflects these patterns (
iv. For situations where monitored air quality concentrations vary across the modeling domain, it may be appropriate to consider air quality monitoring data from multiple monitors within the project area.
d. Determination of the appropriate background concentrations should be consistent with appropriate EPA modeling guidance
e. Considering the spatial and temporal variability throughout a typical modeling domain on an hourly basis and the complexities and limitations of hourly observations from the ambient monitoring network, the EPA does not recommend hourly or daily pairing of monitored background and modeled concentrations except in rare cases of relatively isolated sources where the available monitor can be shown to be representative of the ambient concentration levels in the areas of maximum impact from the proposed new source. The implicit assumption underlying hourly pairing is that the background monitored levels for each hour are spatially uniform and that the monitored values are fully representative of background levels at each receptor for each hour. Such an assumption clearly ignores the many factors that contribute to the temporal and spatial variability of ambient concentrations across a typical modeling domain on an hourly basis. In most cases, the seasonal (or quarterly) pairing of monitored and modeled concentrations should sufficiently address situations to which the impacts from modeled emissions are not temporally correlated with background monitored levels.
f. In those cases where adequately representative monitoring data to characterize background concentrations are not available, it may be appropriate to use results from a regional-scale photochemical grid model, or other representative model application, as background concentrations consistent with the considerations discussed above and in consultation with the appropriate reviewing authority (paragraph 3.0(b)).
a. In multi-source areas, determining the appropriate background concentration involves: (1) Identification and characterization of contributions from nearby sources through explicit modeling, and (2) characterization of contributions from other sources through adequately representative ambient monitoring data. A key point here is the interconnectedness of each component in that the question of which nearby sources to include in the cumulative modeling is inextricably linked to the question of what the ambient monitoring data represents within the project area.
b.
i. The pattern of concentration gradients can vary significantly based on the averaging period being assessed. In general, concentration gradients will be smaller and more spatially uniform for annual averages than for short-term averages, especially for hourly averages. The spatial distribution of annual impacts around a source will often have a single peak downwind of the source based on the prevailing wind direction, except in cases where terrain or other geographic effects are important. By contrast, the spatial distribution of peak short-term impacts will typically show several localized concentration peaks with more significant gradient.
ii. Concentration gradients associated with a particular source will generally be largest between that source's location and the distance to the maximum ground-level concentrations from that source. Beyond the maximum impact distance, concentration gradients will generally be much smaller and more spatially uniform. Thus, the magnitude of a concentration gradient will be greatest in the proximity of the source and will generally not be significant at distances greater than 10 times the height of the stack(s) at that source without consideration of terrain influences.
iii. The number of nearby sources to be explicitly modeled in the air quality analysis is expected to be few except in unusual situations. In most cases, the few nearby sources will be located within the first 10 to 20 km from the source(s) under consideration. Owing to both the uniqueness of each modeling situation and the large number of variables involved in identifying nearby sources, no attempt is made here to comprehensively define a “significant concentration gradient.” Rather, identification of nearby sources calls for the exercise of professional judgment by the appropriate reviewing authority (paragraph 3.0(b)). This guidance is not intended to alter the exercise of that judgment or to
c. For cumulative impact analyses of short-term and annual ambient standards, the nearby sources as well as the project source(s) must be evaluated using an appropriate appendix A model or approved alternative model with the emission input data shown in Table 8-1 or 8-2.
i. When modeling a nearby source that does not have a permit and the emissions limits contained in the SIP for a particular source category is greater than the emissions possible given the source's maximum physical capacity to emit, the “maximum allowable emissions limit” for such a nearby source may be calculated as the emissions rate representative of the nearby source's maximum physical capacity to emit, considering its design specifications and allowable fuels and process materials. However, the burden is on the permit applicant to sufficiently document what the maximum physical capacity to emit is for such a nearby source.
ii. It is appropriate to model nearby sources only during those times when they, by their nature, operate at the same time as the primary source(s) or could have impact on the averaging period of concern. Accordingly, it is not necessary to model impacts of a nearby source that does not, by its nature, operate at the same time as the primary source or could have impact on the averaging period of concern, regardless of an identified significant concentration gradient from the nearby source. The burden is on the permit applicant to adequately justify the exclusion of nearby sources to the satisfaction of the appropriate reviewing authority (paragraph 3.0(b)). The following examples illustrate two cases in which a nearby source may be shown not to operate at the same time as the primary source(s) being modeled: (1) Seasonal sources (only used during certain seasons of the year). Such sources would not be modeled as nearby sources during times in which they do not operate; and (2) Emergency backup generators, to the extent that they do not operate simultaneously with the sources that they back up. Such emergency equipment would not be modeled as nearby sources.
d.
a. This subsection covers meteorological input data for use in dispersion modeling for regulatory applications and is separate from recommendations made for photochemical grid modeling. Recommendations for meteorological data for photochemical grid modeling applications are outlined in the latest version of EPA's
b. The meteorological data used as input to a dispersion model should be selected on the basis of spatial and climatological (temporal) representativeness as well as the ability of the individual parameters selected to characterize the transport and dispersion conditions in the area of concern. The representativeness of the measured data is dependent on numerous factors including, but not limited to: (1) The proximity of the meteorological monitoring site to the area under consideration; (2) the complexity of the terrain; (3) the exposure of the meteorological monitoring site; and (4) the period of time during which data are collected. The spatial representativeness of the data can be adversely affected by large distances between the source and receptors of interest and the complex topographic characteristics of the area. Temporal representativeness is a function of the year-to-year variations in weather conditions. Where appropriate, data representativeness should be viewed in terms of the appropriateness of the data for constructing realistic boundary layer profiles and, where applicable, three-dimensional meteorological fields, as described in paragraphs (c) and (d) of this subsection.
c. The meteorological data should be adequately representative and may be site-specific data, data from a nearby National Weather Service (NWS) or comparable station, or prognostic meteorological data. The implementation of NWS Automated Surface Observing Stations (ASOS) in the early 1990's should not preclude the use of NWS ASOS data if such a station is determined to be representative of the modeled area.
d. Model input data are normally obtained either from the NWS or as part of a site-specific measurement program. State climatology offices, local universities, FAA, military stations, industry, and pollution control agencies may also be sources of such data. In specific cases, prognostic meteorological data may be appropriate for use and obtained from similar sources. Some recommendations and requirements for the use of each type of data are included in this subsection.
a. AERMET
b. Regulatory application of AERMOD necessitates careful consideration of the meteorological data for input to AERMET. Data representativeness, in the case of AERMOD, means utilizing data of an appropriate type for constructing realistic boundary layer profiles. Of particular importance is the requirement that all meteorological data used as input to AERMOD should be adequately representative of the transport and dispersion within the analysis domain. Where surface conditions vary significantly over the analysis domain, the emphasis in assessing representativeness should be given to adequate characterization of transport and dispersion between the source(s) of concern and areas where maximum design concentrations are anticipated to occur. The EPA recommends that the surface characteristics input to AERMET should be representative of the land cover in the vicinity of the meteorological data,
c. Regulatory application of CTDMPLUS requires the input of multi-level measurements of wind speed, direction, temperature, and turbulence from an appropriately sited meteorological tower. The measurements should be obtained up to the representative plume height(s) of interest. Plume heights of interest can be determined by use of screening procedures such as CTSCREEN.
d. Regulatory application of OCD requires meteorological data over land and over water.
e. The model user should acquire enough meteorological data to ensure that worst-case meteorological conditions are adequately represented in the model results. The use of 5 years of adequately representative NWS or comparable meteorological data, at least 1 year of site-specific, or at least 3 years of prognostic meteorological data, are required. If 1 year or more, up to 5 years, of site-specific data are available, these data are preferred for use in air quality analyses. Depending on completeness of the data record, consecutive years of NWS, site-specific, or prognostic data are preferred. Such data must be subjected to quality assurance procedures as described in section 8.4.4.2.
f. Objective analysis in meteorological modeling is to improve meteorological analyses (the “
a. The NWS meteorological data are routinely available and familiar to most model users. Although the NWS does not provide direct measurements of all the needed dispersion model input variables, methods have been developed and successfully used to translate the basic NWS data to the needed model input. Site-specific measurements of model input parameters have been made for many modeling studies, and those methods and techniques are becoming more widely applied, especially in situations such as complex terrain applications, where available NWS data are not adequately representative. However, there are many modeling applications where NWS data are adequately representative and the applications still rely heavily on the NWS data.
b. Many models use the standard hourly weather observations available from the National Centers for Environmental Information (NCEI).
a. The preferred models listed in appendix A all accept, as input, the NWS meteorological data preprocessed into model compatible form. If NWS data are judged to be adequately representative for a specific modeling application, they may be used. The NCEI makes available surface
b. Although most NWS wind measurements are made at a standard height of 10 m, the actual anemometer height should be used as input to the preferred meteorological processor and model.
c. Standard hourly NWS wind directions are reported to the nearest 10 degrees. Due to the coarse resolution of these data, a specific set of randomly generated numbers has been developed by the EPA and should be used when processing standard hourly NWS data for use in the preferred EPA models to ensure a lack of bias in wind direction assignments within the models.
d. Beginning with year 2000, NCEI began archiving 2-minute winds, reported every minute to the nearest degree for NWS ASOS sites. The AERMINUTE processor was developed to read those winds and calculate hourly average winds for input to AERMET. When such data are available for the NWS ASOS site being processed, the AERMINUTE processor should be used, in most cases, to calculate hourly average wind speed and direction when processing NWS ASOS data for input to AERMOD.
e. Data from universities, FAA, military stations, industry and pollution control agencies may be used if such data are equivalent in accuracy and detail (
f. After valid data retrieval requirements have been met,
a. Spatial or geographical representativeness is best achieved by collection of all of the needed model input data in close proximity to the actual site of the source(s). Site-specific measured data are, therefore, preferred as model input, provided that appropriate instrumentation and quality assurance procedures are followed, and that the data collected are adequately representative (free from inappropriate local or microscale influences) and compatible with the input requirements of the model to be used. It should be noted that, while site-specific measurements are frequently made “on-property” (
a. The EPA guidance
i.
ii.
iii.
iv.
b. All processed site-specific data should be in the form of hourly averages for input to the dispersion model.
i.
ii.
iii. The SRDT method, described in section 6.4.4.2 of reference 107, is modified slightly from that published from earlier work
c.
a. For some modeling applications, there may not be a representative NWS or comparable meteorological station available (
b. The EPA has developed a processor, the MMIF,
a.
b.
c.
a. Treatment of calm or light and variable wind poses a special problem in modeling applications since steady-state Gaussian plume models assume that concentration is inversely proportional to wind speed, depending on model formulations. Procedures have been developed to prevent the occurrence of overly conservative concentration estimates during periods of calms. These procedures acknowledge that a steady-state Gaussian plume model does not apply during calm conditions, and that our knowledge of wind patterns and plume
b. AERMOD, while fundamentally a steady-state Gaussian plume model, contains algorithms for dealing with low wind speed (near calm) conditions. As a result, AERMOD can produce model estimates for conditions when the wind speed may be less than 1m/s, but still greater than the instrument threshold. Required input to AERMET for site-specific data, the meteorological processor for AERMOD, includes a threshold wind speed and a reference wind speed. The threshold wind speed is the greater of the threshold of the instrument used to collect the wind speed data or wind direction sensor.
a. Hourly concentrations calculated with steady-state Gaussian plume models using calms should not be considered valid; the wind and concentration estimates for these hours should be disregarded and considered to be missing. Model predicted concentrations for 3-, 8-, and 24-hour averages should be calculated by dividing the sum of the hourly concentrations for the period by the number of valid or non-missing hours. If the total number of valid hours is less than 18 for 24-hour averages, less than 6 for 8-hour averages, or less than 3 for 3-hour averages, the total concentration should be divided by 18 for the 24-hour average, 6 for the 8-hour average, and 3 for the 3-hour average. For annual averages, the sum of all valid hourly concentrations is divided by the number of non-calm hours during the year. AERMOD has been coded to implement these instructions. For hours that are calm or missing, the AERMOD hourly concentrations will be zero. For other models listed in appendix A, a post-processor computer program, CALMPRO
b. Stagnant conditions that include extended periods of calms often produce high concentrations over wide areas for relatively long averaging periods. The standard steady-state Gaussian plume models are often not applicable to such situations. When stagnation conditions are of concern, other modeling techniques should be considered on a case-by-case basis (
c. When used in steady-state Gaussian plume models other than AERMOD, measured site-specific wind speeds of less than 1 m/s but higher than the response threshold of the instrument should be input as 1 m/s; the corresponding wind direction should also be input. Wind observations below the response threshold of the instrument should be set to zero, with the input file in ASCII format. For input to AERMOD, no such adjustment should be made to the site-specific wind data, as AERMOD has algorithms to account for light or variable winds as discussed in section 8.4.6.1(a). For NWS ASOS data, especially data using the 1-minute ASOS winds, a wind speed threshold option is allowed with a recommended speed of 0.5 m/s.
a. Standardized procedures are valuable in the review of air quality modeling and data analyses conducted to support SIP submittals and revisions, NSR, or other EPA requirements to ensure consistency in their regulatory application. This section recommends procedures specific to NSR that facilitate some degree of standardization while at the same time allowing the flexibility needed to assure the technically best analysis for each regulatory application. For SIP attainment demonstrations, refer to the appropriate EPA guidance
b. Air quality model estimates, especially with the support of measured air quality data, are the preferred basis for air quality demonstrations. A number of actions have been taken to ensure that the best air quality model is used correctly for each regulatory application and that it is not arbitrarily imposed.
• First, the
• Second, the preferred models have been subjected to a systematic performance evaluation and a scientific peer review. Statistical performance measures, including measures of difference (or residuals) such as bias, variance of difference and gross variability of the difference, and measures of correlation such as time, space, and time and space combined, as described in section 2.1.1, were generally followed.
• Third, more specific information has been provided for considering the incorporation of new models into the
c. Air quality modeling is the preferred basis for air quality demonstrations. Nevertheless, there are rare circumstances where the performance of the preferred air quality model may be shown to be less than reasonably acceptable or where no preferred air quality model, screening model or technique, or alternative model are suitable for the situation. In these unique instances, there is the possibility of assuring compliance and establishing emissions limits for an existing source solely on the basis of observed air quality data in lieu of an air quality modeling analysis. Comprehensive air quality monitoring in the vicinity of the existing source with proposed modifications will be necessary in these cases. The same attention should be given to the detailed analyses of the air quality data as would be applied to a model performance evaluation.
d. The current levels and forms of the NAAQS for the six criteria pollutants can be found on the EPA's NAAQS Web site at
e. This section discusses general recommendations on the regulatory application of models for the purposes of NSR, including PSD permitting, and particularly for estimating design concentration(s), appropriately comparing these estimates to NAAQS and PSD increments, and developing emissions limits. This section also provides the criteria necessary for considering use of an analysis based on measured ambient data in lieu of modeling as the sole basis for demonstrating compliance with NAAQS and PSD increments.
a. Every effort should be made by the appropriate reviewing authority (paragraph
a. Under the PSD permitting program, an air quality analysis for criteria pollutants is required to demonstrate that emissions from the construction or operation of a proposed new source or modification will not cause or contribute to a violation of the NAAQS or PSD increments.
i. For a NAAQS assessment, the design concentration is the combination of the appropriate background concentration (section 8.3) with the estimated modeled impact of the proposed source. The NAAQS design concentration is then compared to the applicable NAAQS.
ii. For a PSD increment assessment, the design concentration includes impacts occurring after the appropriate baseline date from all increment-consuming and increment-expanding sources. The PSD increment design concentration is then compared to the applicable PSD increment.
b. The specific form of the NAAQS for the pollutant(s) of concern will also influence how the background and modeled data should be combined for appropriate comparison with the respective NAAQS in such a modeling demonstration. Given the potential for revision of the form of the NAAQS and the complexities of combining background and modeled data, specific details on this process can be found in the applicable modeling guidance available on the EPA's SCRAM Web site (section 2.3). Modeled concentrations should not be rounded before comparing the resulting design concentration to the NAAQS or PSD increments. Ambient monitoring and dispersion modeling address different issues and needs relative to each aspect of the overall air quality assessment.
c. The PSD increments for criteria pollutants are listed in 40 CFR 52.21(c) and 40 CFR 51.166(c). For short-term increments, these maximum allowable increases in pollutant concentrations may be exceeded once per year at each site, while the annual increment may not be exceeded. The highest, second-highest increase in estimated concentrations for the short-term averages, as determined by a model, must be less than or equal to the permitted increment. The modeled annual averages must not exceed the increment.
d. Receptor sites for refined dispersion modeling should be located within the modeling domain (section 8.1). In designing a receptor network, the emphasis should be placed on receptor density and location, not total number of receptors. Typically, the density of receptor sites should be progressively more resolved near the new or modifying source, areas of interest, and areas with the highest concentrations with sufficient detail to determine where possible violations of a NAAQS or PSD increments are most likely to occur. The placement of receptor sites should be determined on a case-by-case basis, taking into consideration the source characteristics, topography, climatology, and monitor sites. Locations of particular importance include: (1) The area of maximum impact of the point source; (2) the area of maximum impact of nearby sources; and (3) the area where all sources combine to cause maximum impact. Depending on the complexities of the source and the environment to which the source is located, a dense array of receptors may be required in some cases. In order to avoid unreasonably large computer runs due to an excessively large array of receptors, it is often desirable to model the area twice. The first model run would use a moderate number of receptors more resolved near the new or modifying source and over areas of interest. The second model run would modify the receptor network from the first model run with a denser array of receptors in areas showing potential for high concentrations and possible violations, as indicated by the results of the first model run. Accordingly, the EPA neither anticipates nor encourages that numerous iterations of modeling runs be made to continually refine the receptor network.
a. As described in this subsection, the recommended procedure for conducting either a NAAQS or PSD increments assessment under PSD permitting is a multi-stage approach that includes the following two stages:
i. The EPA describes the first stage as a single-source impact analysis, since this stage involves considering only the impact of the new or modifying source. There are two possible levels of detail in conducting a single-source impact analysis with the model user beginning with use of a screening model and proceeding to use of a refined model as necessary.
ii. The EPA describes the second stage as a cumulative impact analysis, since it takes into account all sources affecting the air quality in an area. In addition to the project source impact, this stage includes consideration of background, which includes contributions from nearby sources and other sources (
b. Each stage should involve increasing complexity and details, as required, to fully demonstrate that a new or modifying source will not cause or contribute to a violation of any NAAQS or PSD increment. As such, starting with a single-source impact analysis is recommended because, where the analysis at this stage is sufficient to demonstrate that a source will not cause or contribute to any potential violation, this may alleviate the need for a more time-consuming and comprehensive cumulative modeling analysis.
c. The single-source impact analysis, or first stage of an air quality analysis, should begin by determining the potential of a proposed new or modifying source to cause or contribute to a NAAQS or PSD increment violation. In certain circumstances, a screening model or technique may be used instead of the preferred model because it will provide estimated worst-case ambient impacts from the proposed new or modifying source. If these worst case ambient concentration estimates indicate that the source will not cause or contribute to any potential violation of a NAAQS or PSD increment, then the screening analysis should generally be sufficient for the required demonstration under PSD. If the ambient concentration estimates indicate that the source's emissions have the potential to cause or contribute to a violation, then the use of a refined model to estimate the source's impact should be pursued. The refined modeling analysis should use a model or technique consistent with the
d. The cumulative impact analysis, or the second stage of an air quality analysis, should be conducted with the same refined model or technique to characterize the project source and then include the appropriate background concentrations (section 8.3). The resulting design concentrations should be used to determine whether the source will cause or contribute to a NAAQS or PSD increment violation. This determination should be based on: (1) The appropriate design concentration for each applicable NAAQS (and averaging period); and (2) whether the source's emissions cause or contribute to a violation at the time and location of any modeled
a. Emissions limits and resulting control requirements should be established to provide for compliance with each applicable NAAQS (and averaging period) and PSD increment. It is possible that multiple emissions limits will be required for a source to demonstrate compliance with several criteria pollutants (and averaging periods) and PSD increments. Case-by-case determinations must be made as to the appropriate form of the limits,
a. As described throughout the
b. There may be rare circumstances where the performance of the preferred air quality model will be shown to be less than reasonably acceptable when compared with air quality monitoring data measured in the vicinity of an existing source. Additionally, there may not be an applicable preferred air quality model, screening technique, or justifiable alternative model suitable for the situation. In these unique instances, there may be the possibility of establishing emissions limits and demonstrating compliance with the NAAQS and PSD increments solely on the basis of analysis of observed air quality data in lieu of an air quality modeling analysis. However, only in the case of a modification to an existing source should air quality monitoring data alone be a basis for determining adequate emissions limits or for demonstration that the modification will not cause or contribute to a violation of any NAAQS or PSD increment.
c. The following items should be considered prior to the acceptance of an analysis of measured air quality data as the sole basis for an air quality demonstration or determining an emissions limit:
i. Does a monitoring network exist for the pollutants and averaging times of concern in the vicinity of the existing source?
ii. Has the monitoring network been designed to locate points of maximum concentration?
iii. Do the monitoring network and the data reduction and storage procedures meet EPA monitoring and quality assurance requirements?
iv. Do the dataset and the analysis allow impact of the most important individual sources to be identified if more than one source or emission point is involved?
v. Is at least one full year of valid ambient data available?
vi. Can it be demonstrated through the comparison of monitored data with model results that available air quality models and techniques are not applicable?
d. Comprehensive air quality monitoring in the area affected by the existing source with proposed modifications will be necessary in these cases. Additional meteorological monitoring may also be necessary. The appropriate number of air quality and meteorological monitors from a scientific and technical standpoint is a function of the situation being considered. The source configuration, terrain configuration, and meteorological variations all have an impact on number and optimal placement of monitors. Decisions on the monitoring network appropriate for this type of analysis can only be made on a case-by-case basis.
e. Sources should obtain approval from the appropriate reviewing authority (paragraph 3.0(b)) and the EPA Regional Office for the monitoring network prior to the start of monitoring. A monitoring protocol agreed to by all parties involved is necessary to assure that ambient data are collected in a consistent and appropriate manner. The design of the network, the number, type, and location of the monitors, the sampling period, averaging time, as well as the need for meteorological monitoring or the use of mobile sampling or plume tracking techniques, should all be specified in the protocol and agreed upon prior to start-up of the network.
f. Given the uniqueness and complexities of these rare circumstances, the procedures can only be established on a case-by-case basis for analyzing the source's emissions data and the measured air quality monitoring data, and for projecting with a reasoned basis the air quality impact of a proposed modification to an existing source in order to demonstrate that emissions from the construction or operation of the modification will not cause or contribute to a violation of the applicable NAAQS and PSD increment, and to determine adequate emissions limits. The same attention should be given to the detailed analyses of the air quality data as would be applied to a comprehensive model performance evaluation. In some cases, the monitoring data collected for use in the performance evaluation of preferred air quality models, screening technique, or existing alternative models may help inform the development of a suitable new alternative model. Early coordination with the appropriate reviewing authority (paragraph 3.0(b)) and the EPA Regional Office is fundamental with respect to any potential use of measured data in lieu of model estimates.
(1) This appendix summarizes key features of refined air quality models preferred for specific regulatory applications. For each model, information is provided on availability, approximate cost (where applicable), regulatory use, data input, output format and options, simulation of atmospheric physics, and accuracy. These models may be used without a formal demonstration of applicability provided they satisfy the recommendations for regulatory use; not all options in the models are necessarily recommended for regulatory use.
(2) Many of these models have been subjected to a performance evaluation using comparisons with observed air quality data. Where possible, several of the models contained herein have been subjected to evaluation exercises, including: (1) Statistical performance tests recommended by the American Meteorological Society, and (2) peer scientific reviews. The models in this appendix have been selected on the basis of the results of the model evaluations, experience with previous use, familiarity of the model to various air quality programs, and the costs and resource requirements for use.
(3) Codes and documentation for all models listed in this appendix are available from the EPA's Support Center for Regulatory Air Models (SCRAM) Web site at
The model codes and associated documentation are available on EPA's SCRAM Web site (paragraph A.0(3)).
AERMOD is a steady-state plume dispersion model for assessment of pollutant concentrations from a variety of sources. AERMOD simulates transport and dispersion from multiple point, area, or volume sources based on an up-to-date characterization of the atmospheric boundary layer. Sources may be located in rural or urban areas, and receptors may be located in simple or complex terrain. AERMOD accounts for building wake effects (
(1) AERMOD is appropriate for the following applications:
• Point, volume, and area sources;
• Buoyant, elevated line sources (
• Mobile sources;
• Surface, near-surface, and elevated releases;
• Rural or urban areas;
• Simple and complex terrain;
• Transport distances over which steady- state assumptions are appropriate, up to 50km;
• 1-hour to annual averaging times; and
• Continuous toxic air emissions.
(2) For regulatory applications of AERMOD, the regulatory default option should be set,
(1) Source data: Required inputs include source type, location, emission rate, stack height, stack inside diameter, stack gas exit velocity, stack gas exit temperature, area and volume source dimensions, and source base elevation. For point sources subject to the influence of building downwash, direction-specific building dimensions (processed through the BPIPPRM building processor) should be input. Variable emission rates are optional. Buoyant line sources require coordinates of the end points of the line, release height, emission rate, average line source width, average building width, average spacing between buildings, and average line source buoyancy parameter. For mobile sources, traffic volume; emission factor, source height, and mixing zone width are needed to determine appropriate model inputs.
(2) Meteorological data: The AERMET meteorological preprocessor requires input of surface characteristics, including surface roughness (zo), Bowen ratio, and albedo, as well as, hourly observations of wind speed between 7zo and 100 m (reference wind speed measurement from which a vertical profile can be developed), wind direction, cloud cover, and temperature between zo and 100 m (reference temperature measurement from which a vertical profile can be developed). Meteorological data can be in the
(i) Data used as input to AERMET should possess an adequate degree of representativeness to ensure that the wind, temperature and turbulence profiles derived by AERMOD are both laterally and vertically representative of the source impact area. The adequacy of input data should be judged independently for each variable. The values for surface roughness, Bowen ratio, and albedo should reflect the surface characteristics in the vicinity of the meteorological tower or representative grid cell when using prognostic data, and should be adequately representative of the modeling domain. Finally, the primary atmospheric input variables, including wind speed and direction, ambient temperature, cloud cover, and a morning upper air sounding, should also be adequately representative of the source area when using observed data.
(ii) For applications involving the use of site-specific meteorological data that includes turbulences parameters (
(iii) For recommendations regarding the length of meteorological record needed to perform a regulatory analysis with AERMOD,
(3) Receptor data: Receptor coordinates, elevations, height above ground, and hill height scales are produced by the AERMAP terrain preprocessor for input to AERMOD. Discrete receptors and/or multiple receptor grids, Cartesian and/or polar, may be employed in AERMOD. AERMAP requires input of DEM or NED terrain data produced by the USGS, or other equivalent data. AERMAP can be used optionally to estimate source elevations.
Printed output options include input information, high concentration summary tables by receptor for user-specified averaging periods, maximum concentration summary tables, and concurrent values summarized by receptor for each day processed. Optional output files can be generated for: A listing of occurrences of exceedances of user-specified threshold value; a listing of concurrent (raw) results at each receptor for each hour modeled, suitable for post-processing; a listing of design values that can be imported into graphics software for plotting contours; a listing of results suitable for NAAQS analyses including NAAQS exceedances and culpability analyses; an unformatted listing of raw results above a threshold value with a special structure for use with the TOXX model component of TOXST; a listing of concentrations by rank (
AERMOD is a steady-state plume model, using Gaussian distributions in the vertical and horizontal for stable conditions, and in the horizontal for convective conditions. The vertical concentration distribution for convective conditions results from an assumed bi-Gaussian probability density function of the vertical velocity.
AERMOD is applicable to primary pollutants and continuous releases of toxic and hazardous waste pollutants. Chemical transformation is treated by simple exponential decay.
AERMOD applies user-specified locations for sources and receptors. Actual separation between each source-receptor pair is used. Source and receptor elevations are user input or are determined by AERMAP using USGS DEM or NED terrain data. Receptors may be located at user-specified heights above ground level.
(1) In the convective boundary layer (CBL), the transport and dispersion of a plume is characterized as the superposition of three modeled plumes: (1) The direct plume (from the stack); (2) the indirect plume; and (3) the penetrated plume, where the indirect plume accounts for the lofting of a buoyant plume near the top of the boundary layer, and the penetrated plume accounts for the portion of a plume that, due to its buoyancy, penetrates above the mixed layer, but can disperse downward and re-enter the mixed layer. In the CBL, plume rise is superposed on the displacements by random convective velocities (Weil
(2) In the stable boundary layer, plume rise is estimated using an iterative approach to account for height-dependent lapse rates, similar to that in the CTDMPLUS model (
(3) Stack-tip downwash and buoyancy induced dispersion effects are modeled. Building wake effects are simulated for stacks subject to building downwash using the methods contained in the PRIME downwash algorithms (Schulman,
(4) For elevated terrain, AERMOD incorporates the concept of the critical dividing streamline height, in which flow below this height remains horizontal, and flow above this height tends to rise up and over terrain (Snyder
Vertical profiles of wind are calculated for each hour based on measurements and surface-layer similarity (scaling) relationships. At a given height above ground, for a given hour, winds are assumed constant over the modeling domain. The effect of the vertical variation in horizontal wind speed on dispersion is accounted for through simple averaging over the plume depth.
In convective conditions, the effects of random vertical updraft and downdraft velocities are simulated with a bi-Gaussian probability density function. In both convective and stable conditions, the mean vertical wind speed is assumed equal to zero.
Gaussian horizontal dispersion coefficients are estimated as continuous functions of the parameterized (or measured) ambient lateral turbulence and also account for buoyancy-induced and building wake-induced turbulence. Vertical profiles of lateral turbulence are developed from measurements and similarity (scaling) relationships. Effective turbulence values are determined from the portion of the vertical profile of lateral turbulence between the plume height and the receptor height. The effective lateral turbulence is then used to estimate horizontal dispersion.
In the stable boundary layer, Gaussian vertical dispersion coefficients are estimated as continuous functions of parameterized vertical turbulence. In the convective boundary layer, vertical dispersion is characterized by a bi-Gaussian probability density function and is also estimated as a continuous function of parameterized vertical turbulence. Vertical turbulence profiles are developed from measurements and similarity (scaling) relationships. These turbulence profiles account for both convective and mechanical turbulence. Effective turbulence values are determined from the portion of the vertical profile of vertical turbulence between the plume height and the receptor height. The effective vertical turbulence is then used to estimate vertical dispersion.
Chemical transformations are generally not treated by AERMOD. However, AERMOD does contain an option to treat chemical transformation using simple exponential decay, although this option is typically not used in regulatory applications except for sources of sulfur dioxide in urban areas. Either a decay coefficient or a half-life is input by the user. Note also that the Plume Volume Molar Ratio Method and the Ozone Limiting Method (section 4.2.3.4) for NO
AERMOD can be used to treat dry and wet deposition for both gases and particles.
The model codes and associated documentation are available on the EPA's SCRAM Web site (paragraph A.0(3)).
CTDMPLUS is a refined point source Gaussian air quality model for use in all stability conditions for complex terrain applications. The model contains, in its entirety, the technology of CTDM for stable and neutral conditions. However, CTDMPLUS can also simulate daytime, unstable conditions, and has a number of additional capabilities for improved user friendliness. Its use of meteorological data and terrain information is different from other EPA models; considerable detail for both types of input data is required and is supplied by preprocessors specifically designed for CTDMPLUS. CTDMPLUS requires the parameterization of individual hill shapes using the terrain preprocessor and the association of each model receptor with a particular hill.
CTDMPLUS is appropriate for the following applications:
• Elevated point sources;
• Terrain elevations above stack top;
• Rural or urban areas;
• Transport distances less than 50 kilometers; and
• 1-hour to annual averaging times when used with a post-processor program such as CHAVG.
(1) Source data: For each source, user supplies source location, height, stack diameter, stack exit velocity, stack exit temperature, and emission rate; if variable emissions are appropriate, the user supplies hourly values for emission rate, stack exit velocity, and stack exit temperature.
(2) Meteorological data: For applications of CTDMPLUS, multiple level (typically three or more) measurements of wind speed and direction, temperature and turbulence (wind fluctuation statistics) are required to create the basic meteorological data file (“PROFILE”). Such measurements should be obtained up to the representative plume height(s) of interest (
(3) Receptor data: Receptor names (up to 400) and coordinates, and hill number (each receptor must have a hill number assigned).
(4) Terrain data: User inputs digitized contour information to the terrain preprocessor which creates the TERRAIN data file (for up to 25 hills).
(1) When CTDMPLUS is run, it produces a concentration file, in either binary or text format (user's choice), and a list file containing a verification of model inputs,
• Input meteorological data from “SURFACE” and “PROFILE,”
• Stack data for each source,
• Terrain information,
• Receptor information, and
• Source-receptor location (line printer map).
(2) In addition, if the case-study option is selected, the listing includes:
• Meteorological variables at plume height,
• Geometrical relationships between the source and the hill, and
• Plume characteristics at each receptor,
(3) If the user selects the TOPN option, a summary table of the top four concentrations at each receptor is given. If the ISOR option is selected, a source contribution table for every hour will be printed.
(4) A separate output file of predicted (1-hour only) concentrations (“CONC”) is written if the user chooses this option. Three forms of output are possible:
(i) A binary file of concentrations, one value for each receptor in the hourly sequence as run;
(ii) A text file of concentrations, one value for each receptor in the hourly sequence as run; or
(iii) A text file as described above, but with a listing of receptor information (names, positions, hill number) at the beginning of the file.
(5) Hourly information provided to these files besides the concentrations themselves includes the year, month, day, and hour information as well as the receptor number with the highest concentration.
CTDMPLUS is a refined steady-state, point source plume model for use in all stability conditions for complex terrain applications.
CTDMPLUS may be used to model non- reactive, primary pollutants.
Up to 40 point sources, 400 receptors and 25 hills may be used. Receptors and sources are allowed at any location. Hill slopes are assumed not to exceed 15°, so that the linearized equation of motion for Boussinesq flow are applicable. Receptors upwind of the impingement point, or those associated with any of the hills in the modeling domain, require separate treatment.
(1) As in CTDM, the basic plume rise algorithms are based on Briggs' (1975) recommendations.
(2) A central feature of CTDMPLUS for neutral/stable conditions is its use of a critical dividing-streamline height (H
(3) The model calculates on an hourly (or appropriate steady averaging period) basis how the plume trajectory (and, in stable/neutral conditions, the shape) is deformed by each hill. Hourly profiles of wind and temperature measurements are used by CTDMPLUS to compute plume rise, plume penetration (a formulation is included to handle penetration into elevated stable layers, based on Briggs (1984)), convective scaling parameters, the value of H
CTDMPLUS does not simulate calm meteorological conditions. Both scalar and vector wind speed observations can be read by the model. If vector wind speed is unavailable, it is calculated from the scalar wind speed. The assignment of wind speed (either vector or scalar) at plume height is done by either:
• Interpolating between observations above and below the plume height, or
• Extrapolating (within the surface layer) from the nearest measurement height to the plume height.
Vertical flow is treated for the plume component above the critical dividing streamline height (H
Horizontal dispersion for stable/neutral conditions is related to the turbulence velocity scale for lateral fluctuations, σv, for which a minimum value of 0.2 m/s is used. Convective scaling formulations are used to estimate horizontal dispersion for unstable conditions.
Direct estimates of vertical dispersion for stable/neutral conditions are based on observed vertical turbulence intensity,
Chemical transformation is not treated by CTDMPLUS.
Physical removal is not treated by CTDMPLUS (complete reflection at the ground/hill surface is assumed).
The model codes and associated documentation are available on EPA's SCRAM Web site (paragraph A.0(3)).
(1) OCD is a straight-line Gaussian model developed to determine the impact of offshore emissions from point, area or line sources on the air quality of coastal regions. OCD incorporates overwater plume transport and dispersion as well as changes that occur as the plume crosses the shoreline. Hourly meteorological data are needed from both offshore and onshore locations. These include water surface temperature, overwater air temperature, mixing height, and relative humidity.
(2) Some of the key features include platform building downwash, partial plume penetration into elevated inversions, direct use of turbulence intensities for plume dispersion, interaction with the overland internal boundary layer, and continuous shoreline fumigation.
OCD has been recommended for use by the Bureau of Ocean Energy Management for emissions located on the Outer Continental Shelf (50 FR 12248; 28 March 1985). OCD is applicable for overwater sources where onshore receptors are below the lowest source height. Where onshore receptors are above the lowest source height, offshore plume transport and dispersion may be modeled on a case-by-case basis in consultation with the appropriate reviewing authority (paragraph 3.0(b)).
(1) Source data: Point, area or line source location, pollutant emission rate, building height, stack height, stack gas temperature, stack inside diameter, stack gas exit velocity, stack angle from vertical, elevation of stack base above water surface and gridded specification of the land/water surfaces. As an option, emission rate, stack gas exit velocity and temperature can be varied hourly.
(2) Meteorological data: PCRAMMET is the recommended meteorological data preprocessor for use in applications of OCD employing hourly NWS data. MPRM is the recommended meteorological data preprocessor for applications of OCD employing site-specific meteorological data.
(i) Over land: Surface weather data including hourly stability class, wind direction, wind speed, ambient temperature, and mixing height are required.
(ii) Over water: Hourly values for mixing height, relative humidity, air temperature, and water surface temperature are required; if wind speed/direction are missing, values over land will be used (if available); vertical wind direction shear, vertical temperature gradient, and turbulence intensities are optional.
(3) Receptor data: Location, height above local ground-level, ground-level elevation above the water surface.
(1) All input options, specification of sources, receptors and land/water map including locations of sources and receptors.
(2) Summary tables of five highest concentrations at each receptor for each averaging period, and average concentration for entire run period at each receptor.
(3) Optional case study printout with hourly plume and receptor characteristics. Optional table of annual impact assessment from non-permanent activities.
(4) Concentration output files can be used by ANALYSIS postprocessor to produce the highest concentrations for each receptor, the cumulative frequency distributions for each receptor, the tabulation of all concentrations exceeding a given threshold, and the manipulation of hourly concentration files.
OCD is a Gaussian plume model constructed on the framework of the MPTER model.
OCD may be used to model primary pollutants. Settling and deposition are not treated.
(1) Up to 250 point sources, 5 area sources, or 1 line source and 180 receptors may be used.
(2) Receptors and sources are allowed at any location.
(3) The coastal configuration is determined by a grid of up to 3600 rectangles. Each element of the grid is designated as either land or water to identify the coastline.
(1) The basic plume rise algorithms are based on Briggs' recommendations.
(2) Momentum rise includes consideration of the stack angle from the vertical.
(3) The effect of drilling platforms, ships, or any overwater obstructions near the source are used to decrease plume rise using a revised platform downwash algorithm based on laboratory experiments.
(4) Partial plume penetration of elevated inversions is included using the suggestions of Briggs (1975) and Weil and Brower (1984).
(5) Continuous shoreline fumigation is parameterized using the Turner method where complete vertical mixing through the thermal internal boundary layer (TIBL) occurs as soon as the plume intercepts the TIBL.
(1) Constant, uniform wind is assumed for each hour.
(2) Overwater wind speed can be estimated from overland wind speed using relationship of Hsu (1981).
(3) Wind speed profiles are estimated using similarity theory (Businger, 1973). Surface layer fluxes for these formulas are calculated from bulk aerodynamic methods.
Vertical wind speed is assumed equal to zero.
(1) Lateral turbulence intensity is recommended as a direct estimate of horizontal dispersion. If lateral turbulence intensity is not available, it is estimated from boundary layer theory. For wind speeds less than 8 m/s, lateral turbulence intensity is assumed inversely proportional to wind speed.
(2) Horizontal dispersion may be enhanced because of obstructions near the source. A virtual source technique is used to simulate the initial plume dilution due to downwash.
(3) Formulas recommended by Pasquill (1976) are used to calculate buoyant plume enhancement and wind direction shear enhancement.
(4) At the water/land interface, the change to overland dispersion rates is modeled using a virtual source. The overland dispersion rates can be calculated from either lateral turbulence intensity or Pasquill-Gifford curves. The change is implemented where the plume intercepts the rising internal boundary layer.
(1) Observed vertical turbulence intensity is not recommended as a direct estimate of vertical dispersion. Turbulence intensity should be estimated from boundary layer theory as default in the model. For very stable conditions, vertical dispersion is also a function of lapse rate.
(2) Vertical dispersion may be enhanced because of obstructions near the source. A virtual source technique is used to simulate the initial plume dilution due to downwash.
(3) Formulas recommended by Pasquill (1976) are used to calculate buoyant plume enhancement.
(4) At the water/land interface, the change to overland dispersion rates is modeled using a virtual source. The overland dispersion rates can be calculated from either vertical turbulence intensity or the Pasquill-Gifford coefficients. The change is implemented where the plume intercepts the rising internal boundary layer.
Chemical transformations are treated using exponential decay. Different rates can be specified by month and by day or night.
Physical removal is also treated using exponential decay.
U.S. Citizenship and Immigration Services, DHS.
Final rule.
This final rule amends Department of Homeland Security (DHS) regulations to implement the Secretary of Homeland Security's discretionary parole authority in order to increase and enhance entrepreneurship, innovation, and job creation in the United States. The final rule adds new regulatory provisions guiding the use of parole on a case-by-case basis with respect to entrepreneurs of start-up entities who can demonstrate through evidence of substantial and demonstrated potential for rapid business growth and job creation that they would provide a significant public benefit to the United States. Such potential would be indicated by, among other things, the receipt of significant capital investment from U.S. investors with established records of successful investments, or obtaining significant awards or grants from certain Federal, State or local government entities. If granted, parole would provide a temporary initial stay of up to 30 months (which may be extended by up to an additional 30 months) to facilitate the applicant's ability to oversee and grow his or her start-up entity in the United States.
This final rule is effective July 17, 2017.
Steven Viger, Adjudications Officer, Office of Policy and Strategy, U.S. Citizenship and Immigration Services, Department of Homeland Security, 20 Massachusetts Avenue NW., Suite 1100, Washington, DC 20529-2140; Telephone (202) 272-1470.
Section 212(d)(5) of the Immigration and Nationality Act (INA), 8 U.S.C. 1182(d)(5), confers upon the Secretary of Homeland Security the discretionary authority to parole individuals into the United States temporarily, on a case-by-case basis, for urgent humanitarian reasons or significant public benefit. DHS is amending its regulations implementing this authority to increase and enhance entrepreneurship, innovation, and job creation in the United States. As described in more detail below, the final rule would establish general criteria for the use of parole with respect to entrepreneurs of start-up entities who can demonstrate through evidence of substantial and demonstrated potential for rapid growth and job creation that they would provide a significant public benefit to the United States. In all cases, whether to parole a particular individual under this rule is a discretionary determination that would be made on a case-by-case basis.
Given the complexities involved in adjudicating applications in this context, DHS has decided to establish by regulation the criteria for the case-by-case evaluation of parole applications filed by entrepreneurs of start-up entities. By including such criteria in regulation, as well as establishing application requirements that are specifically tailored to capture the necessary information for processing parole requests on this basis, DHS expects to facilitate the use of parole in this area.
Under this final rule, an applicant would need to demonstrate that his or her parole would provide a significant public benefit because he or she is the entrepreneur of a new start-up entity in the United States that has significant potential for rapid growth and job creation. DHS believes that such potential would be indicated by, among other things, the receipt of (1) significant capital investment from U.S. investors with established records of successful investments or (2) significant awards or grants from certain Federal, State, or local government entities. The final rule also includes alternative criteria for applicants who partially meet the thresholds for capital investment or government awards or grants and can provide additional reliable and compelling evidence of their entities' significant potential for rapid growth and job creation. An applicant must also show that he or she has a substantial ownership interest in such an entity, has an active and central role in the entity's operations, and would substantially further the entity's ability to engage in research and development or otherwise conduct and grow its business in the United States. The grant of parole is intended to facilitate the applicant's ability to oversee and grow the start-up entity.
DHS believes that this final rule will encourage foreign entrepreneurs to create and develop start-up entities with high growth potential in the United States, which are expected to facilitate research and development in the country, create jobs for U.S. workers, and otherwise benefit the U.S. economy through increased business activity, innovation, and dynamism. Particularly in light of the complex considerations involved in entrepreneur-based parole requests, DHS also believes that this final rule will provide a transparent framework by which DHS will exercise its discretion to adjudicate such requests on a case-by-case basis under section 212(d)(5) of the INA, 8 U.S.C. 1182(d)(5).
The Secretary of Homeland Security's authority for the proposed regulatory amendments can be found in various provisions of the immigration laws. Sections 103(a)(1) and (3) of the INA, 8 U.S.C. 1103(a)(1), (3), provides the Secretary the authority to administer and enforce the immigration and nationality laws. Section 402(4) of the Homeland Security Act of 2002 (HSA), Public Law 107-296, 116 Stat. 2135, 6 U.S.C. 202(4), expressly authorizes the
This final rule adds a new section 8 CFR 212.19 to provide guidance with respect to the use of parole for entrepreneurs of start-up entities based upon significant public benefit. An individual seeking to operate and grow his or her start-up entity in the United States would generally need to demonstrate the following to be considered for a discretionary grant of parole under this final rule:
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This final rule states that an applicant who meets the above criteria (and his or her spouse and minor, unmarried children,
USCIS adjudicators will consider the totality of the evidence, including evidence obtained by USCIS through background checks and other means, to determine whether the applicant has satisfied the above criteria, whether the specific applicant's parole would provide a significant public benefit, and whether negative factors exist that warrant denial of parole as a matter of discretion. To grant parole, adjudicators will be required to conclude, based on the totality of the circumstances, that both: (1) The applicant's parole would provide a significant public benefit, and (2) the applicant merits a grant of parole as a matter of discretion.
If parole is granted, the entrepreneur will be authorized for employment incident to the grant of parole, but only with respect to the entrepreneur's start-up entity. The entrepreneur's spouse and children, if any, will not be authorized for employment incident to the grant of parole, but the entrepreneur's spouse, if paroled into the United States pursuant to 8 CFR 212.19, will be permitted to apply for employment authorization consistent with new 8 CFR 274a.12(c)(34). DHS retains the authority to revoke any such grant of parole at any time as a matter of discretion or if DHS determines that parole no longer provides a significant public benefit, such as when the entity has ceased operations in the United States or DHS has reason to believe that the approved application involves fraud or misrepresentation.
As noted, the purpose of this parole process is to provide qualified entrepreneurs of high-potential start-up entities in the United States with the improved ability to conduct research and development and expand the entities' operations in the United States so that our nation's economy may
An applicant under this rule will generally need to demonstrate the following to be considered for a discretionary grant of an additional period of parole:
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As indicated above, an applicant who generally meets the above criteria and merits a favorable exercise of discretion may be granted an additional 30-month period of re-parole, for a total maximum period of 5 years of parole under 8 CFR 212.19, to work with the same start-up entity based on the significant public benefit that would be served by his or her continued parole in the United States. No more than three entrepreneurs (and their spouses and children) may receive such additional periods of parole with respect to any one qualifying entity.
As with initial parole applications, USCIS adjudicators will consider the totality of the evidence, including evidence obtained by USCIS through verification methods, to determine whether the applicant has satisfied the above criteria and whether his or her continued parole would provide a significant public benefit. To be re-paroled, adjudicators will be required to conclude, based on the totality of the circumstances, both: (1) That the applicant's continued parole would provide a significant public benefit, and (2) that the applicant continues to merit parole as a matter of discretion. If the applicant is re-paroled, DHS retains the authority to revoke parole at any time as a matter of discretion or if DHS determines that parole no longer provides a significant public benefit, such as when the entity has ceased operations in the United States or DHS believes that the application involved fraud or made material misrepresentations.
The entrepreneur and any dependents granted parole under this program will be required to depart the United States when their parole periods have expired or have otherwise been terminated, unless such individuals are otherwise eligible to lawfully remain in the United States. At any time prior to reaching the 5-year limit for parole under this final rule, such individuals may apply for any immigrant or nonimmigrant classification for which they may be eligible (such as classification as an O-1 nonimmigrant or as a lawful permanent resident pursuant to an EB-2 National Interest Waiver). Because parole is not considered an admission to the United States, parolees are ineligible to adjust or change their status in the United States under many immigrant or nonimmigrant visa classifications. For example, if such individuals are approved for a nonimmigrant or employment-based immigrant visa classification, they would generally need to depart the United States and apply for a visa with the Department of State (DOS) for admission to the United States as a nonimmigrant or lawful permanent resident.
Finally, DHS is making conforming changes to the employment authorization regulations at 8 CFR 274a.12(b) and (c), the employment eligibility verification regulations at 8 CFR 274a.2(b), and fee regulations at 8 CFR 103.7(b)(i). The final rule amends 8 CFR 274a.12(b) by: (1) Adding entrepreneur parolees to the classes of
Following careful consideration of public comments received, including relevant data provided by stakeholders, DHS has made several modifications to the regulatory text proposed in the Notice of Proposed Rulemaking (NPRM) published in the
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DHS does not anticipate that this rule will generate significant costs and burdens to private or public entities. Costs of the rule stem from filing fees and opportunity costs associated with applying for parole, and the requirement that the entrepreneur notify DHS of any material changes.
DHS estimates that 2,940 entrepreneurs will be eligible for parole annually and can apply using the Application for Entrepreneur Parole (Form I-941). Each applicant for parole will face a total filing cost—including the application form fee, biometric filing fee, travel costs, and associated opportunity costs—of $1,591, resulting in a total cost of $4,678,336 (undiscounted) for the first full year the rule will take effect and any subsequent year. Additionally, dependent family members (spouses and children) seeking parole with the principal applicant will be required to file an Application for Travel Document (Form I-131) and submit biographical information and biometrics. DHS estimates approximately 3,234 dependent spouses and children could seek parole based on the estimate of 2,940 principal applicants. Each spouse and child 14 years of age and older seeking parole will face a total cost of $765 per applicant,
DHS anticipates that establishing a parole process for those entrepreneurs who stand to provide a significant public benefit will advance the U.S. economy by enhancing innovation, generating capital investments, and creating jobs. DHS does not expect significant negative consequences or labor market impacts from this rule; indeed, DHS believes this rule will encourage entrepreneurs to pursue business opportunities in the United States rather than abroad, which can be expected to generate significant scientific, research and development, and technological impacts that could create new products and produce positive spillover effects to other businesses and sectors. The impacts stand to benefit the economy by supporting and strengthening high-growth, job-creating businesses in the United States.
This final rule will be effective on July 17, 2017, 180 days from the date of publication in the
The Secretary of Homeland Security has discretionary authority to parole into the United States temporarily “under conditions as he may prescribe only on a case-by-case basis for urgent humanitarian reasons or significant public benefit any individual applying for admission to the United States,” regardless of whether the alien is inadmissible. INA section 212(d)(5)(A), 8 U.S.C. 1182(d)(5)(A).
Parole decisions are discretionary determinations and must be made on a case-by-case basis consistent with the INA. To exercise its parole authority, DHS must determine that an individual's parole into the United States is justified by urgent humanitarian reasons or significant public benefit. Even when one of those standards would be met, DHS may nevertheless deny parole as a matter of discretion based on other factors.
Parole is not an admission to the United States.
DHS regulations at 8 CFR 212.5 generally describe DHS's discretionary parole authority, including the authority to set the terms and conditions of parole. Some conditions are described in the regulations, including requiring reasonable assurances that the parolee will appear at all hearings and will depart from the United States when required to do so.
Each of the DHS immigration components—USCIS, U.S. Customs and Border Protection (CBP), and U.S. Immigration and Customs Enforcement (ICE)—has been delegated the authority to parole applicants for admission in accordance with section 212(d)(5) of the INA, 8 U.S.C. 1182(d)(5).
Currently, upon an individual's arrival at a U.S. port of entry with a parole travel document (
Because parole does not constitute an admission, individuals may be paroled into the United States even if they are inadmissible under section 212(a) of the INA, 8 U.S.C. 1182(a). Further, parole does not provide a parolee with nonimmigrant status or lawful permanent resident status. Nor does it provide the parolee with a basis for changing status to that of a nonimmigrant or adjusting status to that of a lawful permanent resident, unless the parolee is otherwise eligible.
Under current regulations, once paroled into the United States, a parolee is eligible to request employment authorization from USCIS by filing a Form I-765 application with USCIS.
Parole will terminate automatically upon the expiration of the authorized parole period or upon the departure of the individual from the United States.
Following careful consideration of public comments received, DHS has made several modifications to the regulatory text proposed in the NPRM (as described above in Section I.C.). The rationale for the proposed rule and the reasoning provided in the background section of that rule remain valid with respect to these regulatory amendments. Section III of this final rule includes a detailed summary and analysis of public comments that are pertinent to the proposed rule and DHS's role in
In response to the proposed rule, DHS received 763 comments during the 45-day public comment period. Of these, 43 comments were duplicate submissions and approximately 242 were letters submitted through mass mailing campaigns. As those letters were sufficiently unique, DHS considered all of these comment submissions. Commenters consisted primarily of individuals but also included startup incubators, companies, venture capital firms, law firms and representatives from State and local governments. Approximately 51 percent of commenters expressed support for the rule and/or offered suggestions for improvement. Nearly 46 percent of commenters expressed general opposition to the rule without suggestions for improvement. For approximately 3 percent of the public comments, DHS could not ascertain whether the commenter supported or opposed the proposed rule.
DHS has reviewed all of the public comments received in response to the proposed rule and addresses relevant comments in this final rule. DHS's responses are grouped by subject area, with a focus on the most common issues and suggestions raised by commenters.
DHS disagrees with the comment asserting that the proposed rule would effectively create a new visa category, which only Congress has the authority to do.
DHS further disagrees with the comment that this rule is inconsistent with the legislative history on parole. Under current law, Congress has expressly authorized the Secretary to grant parole on a case-by-case basis for urgent humanitarian reasons or significant public benefit. The statutory language in place today is somewhat more restrictive than earlier versions of the parole authority, which did not always require case-by-case review and now includes additional limits on the use of parole for refugees and certain alien crewmen.
In addition to the concerns described above, one commenter argued that the proposed rule did not clearly explain whether “the agency intends to grant parole to aliens already present in the United States.” DHS believes it is clear under this rule that an individual who is present in the United States as a nonimmigrant based on an inspection and admission is not eligible for parole without first departing the United States and appearing at a U.S. port of entry to be paroled into United States.
Given the way job creation will already be considered, DHS believes it is unnecessary to make “job quality” its own separate criterion in determining whether to grant parole or re-parole. It is also unclear how the commenter believes DHS should apply any such criterion. Under this final rule, DHS will evaluate the totality of the circumstances, including the evidence about job creation, in determining whether to parole an individual into the United States for significant public benefit.
Given that this is a new and complex process, DHS declines to adopt a separate option of establishing substantial ownership interest based on a valuation of the entrepreneur's ownership interest. DHS believes that the percentages provided within the final rule offer clear guidance to stakeholders and adjudicators as to what constitutes a substantial ownership interest regardless of the industry involved. Reliance upon valuations of an owner's interest would unnecessarily complicate the adjudicative review process, could potentially increase fraud and abuse, and may be burdensome for the applicant to obtain from an independent and reliable source. DHS, therefore, believes that the best indicator of an entrepreneur's ownership interest is the individual's ownership percentage since that is easy for an applicant to establish and provides an objective indicator for DHS to assess. DHS has decided to take an incremental approach and will consider potential modifications in the future after it has assessed the implementation of the rule and its impact on operational resources.
• Letters from relevant government agencies, qualified investors, or established business associations with an understanding of the applicant's knowledge, skills or experience that would advance the entity's business;
• news articles or other similar evidence indicating that the applicant has received significant attention and recognition;
• documentation showing that the applicant or entity has been recently invited to participate in, is currently participating in, or has graduated from one or more established and reputable start-up accelerators;
• documentation showing that the applicant has played an active and central role in the success of prior start-up or other relevant business entities;
• degrees or other documentation indicating that the applicant has knowledge, skills, or experience that would significantly advance the entity's business;
• documentation pertaining to intellectual property of the start-up entity, such as a patent, that was obtained by the applicant or as a result of the applicant's efforts and expertise;
• a position description of the applicant's role in the operations of the company; and
• any other relevant, probative, and credible evidence indicating the applicant's ability to advance the entity's business in the United States.
Particularly given the way this evidence will be evaluated on a case-by-case basis, and the need to ensure parole is justified by significant public benefit, DHS declines to adopt the commenters' suggestion of adopting a rebuttable presumption that certain applicants meet the “well-positioned” requirement. The burden of proof remains with the applicant.
Given the breadth of evidence that can already be considered in these determinations, DHS declines to amend the definition of “entrepreneur” in 8 CFR 212.19(a)(1) to include some consideration of “intellectual property” as a specific metric to determine if the applicant will have an active and central role in the start-up entity. DHS believes it is appropriate to allow for sufficient flexibility in the definition for adjudicators to evaluate each case on its own merits. Given the considerable range of entrepreneurial ventures that might form the basis for an application for parole under this rule, DHS believes that such flexibility is important to ensure that cutting edge industries or groundbreaking ventures are not precluded from consideration simply because of an overly rigid or narrow definition of “entrepreneur.”
DHS believes that the rule provides a clear framework for establishing that a start-up entity has substantial potential for rapid growth and job creation.
DHS does not believe that the rule should be revised to align with 8 CFR 214.2(l)(1)(ii)(G)(
DHS also declines to adopt the investor track record criteria associated with AngelList's requirements, as DHS believes that the past success of qualified investors can be demonstrated sufficiently by utilizing the criteria set forth in the final rule. DHS has maintained the requirements under 8 CFR 212.19(a)(5)(ii) as evidence that the investor has had previous successful investments, which are similar to certain criteria for a start-up entity to demonstrate eligibility for re-parole under this rule.
DHS is not prohibiting foreign investors from investing in the entrepreneur's start-up entity, but rather is simply limiting those investors that can serve as “qualified investors” for purposes of establishing the entrepreneur's eligibility for parole under this rule. DHS anticipates that entrepreneurs living outside the United States will be able to demonstrate eligibility for parole consideration under this rule, whether based on investment from U.S. investors, grants or awards from certain U.S. Government entities, or a mixture of alternative criteria. For all the reasons above, the definition of “qualified investor” will help DHS manage an efficient process for adjudicating requests under this rule while appropriately screening for potential fraud or abuse and ensuring that each grant of parole is justified by significant public benefit to the United States.
DHS emphasizes that the rule does not prohibit investment from U.S. investors who do not have an established track record of substantial investment in start-up entities under the rule's definition of “qualified investor.” Any investment from an investor who is not a qualified investor, however, will not count toward the minimum investment criteria associated with the initial parole period or re-parole period. DHS will, of course, monitor all
As described in greater detail above, these criteria are intended to ensure that investors are bona fide and thus protect the integrity of the parole process under this rule. They are also intended to ensure that a qualifying investment serves as a strong and reliable indicator of the start-up entity's substantial potential for rapid growth and job creation, which is relevant to assessing whether granting parole to an entrepreneur is justified by significant public benefit. DHS declines to adopt a special provision for regional centers approved to participate in the EB-5 visa program. Although such centers are not categorically excluded from the definition of “qualified investor” under this rule, they would need to meet all the same criteria as any other qualified investor.
DHS recognizes that not all changes to the ownership structure of a start-up entity constitute a change of such significance that it would reasonably affect the outcome of the determination of whether the entrepreneur provides, or continues to provide, a significant public benefit to the United States. DHS has revised the final rule to limit material change regarding ownership changes only to “a significant change with respect to ownership and control of the start-up entity.” For example, a significant change with respect to ownership and control of the start-up entity may include a transfer of equity in the start-up entity that results in an owner or owners not previously identified on the Application for Entrepreneur Parole (Form I-941) collectively acquiring a controlling stake in the entity. DHS recognizes that achieving a significant round of funding for the start-up entity during the initial parole period may often constitute the very qualifying investment that renders the entrepreneur eligible for a re-parole period under this rule's significant public benefit test, despite diluting the entrepreneur's ownership interest. While DHS will make these determinations on a case-by-case basis, DHS does not anticipate that such significant changes with respect to ownership and control of the start-up entity will often result in termination of parole. A full vetting of new investors with a significant ownership interest, however, can provide DHS with additional insights into the start-up entity's activities in the United States and will help DHS ensure the entrepreneur is continuing to provide a significant public benefit to the United States. In the future, DHS may issue additional guidance on the scope of such significant changes in ownership interest if deemed necessary.
DHS believes these changes are sufficient to clarify the definition of “material change” in regulation and to provide entrepreneurs with sufficient detail about the kinds of changes that could impact their eligibility and must be reported. Given that this is a new and complex process, DHS will consider potential modifications in the future after it has assessed the implementation of the rule and its impact on operational resources.
DHS agrees with the commenters that evidence of having received substantial investment from a qualified investor may be sufficient to establish that the start-up entity has the potential for rapid growth and job creation (one factor in making parole determinations under this rule).
Under this final rule, spouses of entrepreneur parolees who wish to obtain employment authorization must apply for an EAD pursuant to 8 CFR 274a.12(c)(34), consistent with current parole policy that allows parolees to apply for employment authorization. DHS agrees with the commenter that allowing spouses of entrepreneurs to apply for work authorization may alleviate a significant portion of the potential economic burdens that entrepreneurs and their families may face, such as paying for education expenses for their children, and to ensure that they satisfy the condition on their parole that they maintain household income that is greater than 400 percent of the Federal poverty line, as they grow and develop their start-up entities. Moreover, extending employment authorization to the spouse may further incentivize an international entrepreneur to bring a start-up entity to the United States—along with new jobs, innovation, and growth—rather than create it in another country.
DHS disagrees with the suggestion that evidence of rapid revenue growth or generation of a certain amount of revenue should be a separate criterion under 8 CFR 212.19(b)(2)(ii). In setting threshold criteria, DHS intends to identify reliable indicators of a start-up entity's substantial potential for rapid growth and job creation and, ultimately, of the significant public benefit that a grant of parole would provide in an individual case. DHS does not believe that revenue should be the sole external validation factor as compared to substantial funding from qualified U.S. investors and government entities for initial parole applications. DHS reiterates, however, that a start-up entity's revenue may be taken under consideration, both under the “alternative criteria” test and as part of the totality of evidence relevant to whether the grant of parole in an individual case would be justified by significant public benefit and the person requesting parole deserves a favorable exercise of discretion.
• number of users or customers;
• revenue generated by the start-up entity;
• social impact of the start-up entity;
• national scope of the start-up entity;
• positive effects on the start-up entity's locality or region;
• success using alternative funding platforms, including crowdfunding platforms;
• the applicant's academic degrees;
• the applicant's prior success in operating start-up entities as demonstrated by patented innovations, annual revenue, job creation, or other factors; and
• selection of the start-up entity to participate in one or more established and reputable start-up accelerators or incubators.
With respect to start-up accelerators and incubators, DHS expects to evaluate them on several relevant factors, including years in existence, graduation rates, significant exits by portfolio start-ups, significant investment or fundraising by portfolio start-ups, and valuation of portfolio start-ups.
DHS understands that some applicants will be able to establish that their start-up entity is likely to grow rapidly and create jobs based on other factors beyond only the amount of capital investment or government funding received, which is why DHS has not limited the types of evidence that may be considered under the alternative criteria at 8 CFR 212.19(b)(2)(iii) for those who only partially meet the initial threshold criteria at 8 CFR 212.19(b)(2)(ii)(B).
DHS has also increased the length of the initial parole period from 24 months to 30 months. This change will allow entrepreneurs additional time to seek and receive qualified investments or government funding, to meet the re-parole criteria. If an entrepreneur is unable to meet the minimum funding criterion, moreover, he or she may still be eligible for re-parole based on revenue generated or jobs created.
As noted in the NPRM, DHS is not defining in regulation the specific types of evidence that may be deemed “reliable and compelling” at this time, because DHS seeks to retain flexibility as to the kinds of supporting evidence that may warrant the Secretary's exercise of discretion in granting parole based on significant public benefit. DHS believes, however, that such evidence would need to be compelling to demonstrate that the entrepreneur's presence in the United States would provide a significant public benefit. DHS will evaluate on a case-by-case basis whether such evidence—in conjunction with the entity's substantial funding, revenue generation, or job creation—establishes that the applicant's presence in the United States will provide a significant public benefit during a re-parole period.
The limitation, moreover, will help strengthen the integrity of the international entrepreneur parole process in various ways. Among other things, limiting the number of individuals who may be granted parole under this rule in connection with the same start-up entity will provide an additional safeguard against an entity being used as a means to fraudulently allow individuals to come to the United States. Such a limit diminishes, for example, the incentive to dilute equity in the start-up entity as a means to apply for parole for individuals who are not bona fide entrepreneurs. Finally, DHS clarifies that the rule does not require that additional entrepreneurs, up to 3 entrepreneurs per start-up entity, apply for parole based on the same start-up entity at the same time.
Under this rule, DHS will take steps to ensure that each grant of parole will provide a positive net benefit to the economy of the United States, consistent with the statutory framework authorizing parole only for significant public benefit absent urgent humanitarian issues. In addition to considering all the other positive evidence—from job creation to investment to growth—DHS includes the income threshold as an additional safeguard that the entrepreneur and his or her family will not be eligible to draw upon Federal public benefits or premium tax credits under the Health Insurance Marketplace of the Affordable Care Act. Furthermore, Secretary Johnson indicated in his memorandum titled “Policies Supporting U.S. High-Skilled Business and Workers” that such thresholds would be created so that individuals would not be eligible for these public benefits or premium tax credits in light of the purpose of the policy.
DHS emphasizes that the funding amounts received by a start-up entity from governmental sources or from
However, in this final rule, and as proposed, only the entrepreneur parolee is accorded employment authorization incident to his or her parole.
DHS appreciates that international entrepreneurs may face many challenges in starting and growing a business in the United States, including attracting investment capital or government grants or awards. DHS disagrees with the premise, however, that qualifying investors will be very reluctant to make a qualifying investment in a start-up entity that is wholly or partially owned by an individual that will be seeking a grant of parole under this rule. DHS believes that there are a myriad of factors that go into a decision to invest significant funds in a start-up entity. While the underlying immigration status, or lack thereof, of the start-up entity's owner(s) may be a factor presenting a degree of additional risk, DHS believes that this rule will effectively mitigate some of that risk by providing a known framework under which certain significant public benefit parole requests will be reviewed and adjudicated. This final rule provides investors and entrepreneurs with greater transparency into the evaluation process and manner in which such requests will be reviewed, so that those individuals and entities can weigh the various risks and benefits that might apply to the particular investment decision being considered. Given that this is a new and complex process, DHS has decided to take an incremental approach and will consider potential modifications in the future after assessing the implementation of the rule.
DHS will not adopt the commenter's suggestion to disregard, for purposes of any future immigration applications, any prior unauthorized employment that was used to meet the requirements for parole. DHS believes that such a provision would require a statutory change, as eligibility for certain benefits is barred by statute if the applicant previously worked without authorization.
DHS believes that this final rule provides a realistic and clear option for certain entrepreneurs to actively grow their qualifying start-up entity in the United States. As discussed below, parole is not a nonimmigrant status, and individuals present in the United States in a nonimmigrant status will not be able to change status or otherwise be granted parole without first departing the United States and appearing at a U.S. port of entry for inspection and parole. Under this final rule, however, an individual present in the United States in a nonimmigrant status may apply for and obtain an approval of the Application for Entrepreneur Parole (Form I-941). Filing and obtaining approval of a Form I-941 application under this rule will not, by itself, constitute a violation of the individual's nonimmigrant status. After approval of the Form I-941 application, if the individual decides to rely upon parole to actively grow his or her business in the United States, the individual will need to appear at a U.S. port of entry for a final parole determination to allow him or her to come into the United States as a parolee.
This final rule already provides appropriate criteria under which all applications will be reviewed, including those submitted by any F-1 nonimmigrants. As indicated in this final rule, one basis on which an individual may be considered for parole under this rule is if he or she has raised at least $250,000 in investment capital from a qualifying investor (and meets certain other criteria). Individuals who raise a substantial amount of capital from a qualifying investor, but less than $250,000, may still qualify for and be granted parole under other criteria identified in the rule—including the receipt of a qualifying government grant or award or other reliable and compelling evidence of the start-up entity's substantial potential for rapid growth and job creation.
DHS recognizes that international travel can be essential for the success of some start-up entities. Under existing law, an individual's authorized period of parole ends each time he or she departs the United States.
A number of commenters were more broadly concerned that the overall uncertainty inherent in parole may discourage entrepreneurs from using this rule to start and grow their businesses in the United States. One particular commenter expressed concerns about an entrepreneur's ability to demonstrate nonimmigrant intent for purposes of a visa that does not permit dual intent. Others wanted DHS to consider entrepreneurs who have completed a 5-year parole period, and whose start-ups continue to demonstrate growth, as eligible for an EB-2 immigrant visa with a National Interest Waiver based upon the economic benefit to the United States. Other commenters urged DHS to establish
As discussed in the NPRM, the entrepreneur and any dependents granted parole under this program will be required to depart the United States when their parole periods have expired or have otherwise been terminated, unless such individuals are otherwise eligible to lawfully remain in the United States. Such individuals may apply for any immigrant or nonimmigrant classification for which they may be eligible (such as classification as an O-1 nonimmigrant or lawful permanent residence through employer sponsorship). Individuals who are granted parole under this rule may ultimately be able to qualify for an EB-2 immigrant visa with a National Interest Waiver. If an entrepreneur is approved for a nonimmigrant or employment-based immigrant visa classification, he or she would generally be required to depart the United States and apply for a visa at a U.S. embassy or consulate abroad. As noted above, because parole is not considered an admission to the United States, parolees will be unable to apply to adjust or change their status in the United States under many immigrant or nonimmigrant visa classifications. DHS does not believe that merely being granted parole under this rule would prevent an individual from demonstrating nonimmigrant intent for purposes of obtaining a subsequent nonimmigrant visa for entry into United States. DHS believes that this rule presents sufficient clarity and predictability for many individuals who want to establish and grow their businesses in the United States, and will contribute significantly to economic growth and job creation here. Such positive outcomes may be relevant in the event that entrepreneurs granted parole under this rule later seek to apply for an existing nonimmigrant or immigrant visa.
Because the determination to grant or deny a request for parole is discretionary, the parole process in this final rule may not be relied upon to create any right or benefit, substantive or procedural, enforceable at law or by any individual or other party in removal proceedings, in litigation with the United States, or in any other form or manner. Parole determinations would continue to be discretionary, case-by-case determinations made by DHS, and parole may be revoked or terminated at any time in accordance with the termination provisions established by this rule at 8 CFR 212.19(k). Parolees under this final rule would assume sole risk for any and all costs, expenses, opportunity costs, and any other potential liability resulting from a revocation or termination of parole. A grant of parole would in no way create any reliance or due process interest in obtaining or maintaining parole or being able to remain in the United States to continue to operate a start-up entity or for other reasons.
The commenter expressed particular concern regarding terminations based on material changes. DHS believes that this concern is sufficiently addressed by the parameters set by this rule's definition of material change. Under this rule, material change means any change in facts that could reasonably affect the outcome of the determination whether the entrepreneur provides, or continues to provide, a significant public benefit to the United States.
(1) The facts or information contained in the request for parole were not true and accurate;
(2) The alien failed to timely file or otherwise comply with the material change reporting requirements in this section;
(3) The entrepreneur parolee is no longer employed in a central and active role by the start-up entity or ceases to possess the required ownership stake in the start-up entity;
(4) The alien otherwise violated the terms and conditions of parole; or
(5) Parole was erroneously granted.
Automatic termination will apply upon the expiration of parole or if DHS receives written notice from the parolee informing DHS that he or she is no longer employed by the start-up entity or no longer possesses the required qualifying ownership stake in the start-up entity. DHS believes that these bases for automatic termination clearly evidence that the entrepreneur no longer qualifies for parole under this rule; therefore, notice and opportunity to respond are unnecessary. Additionally, parole of the spouse or child of the entrepreneur will be automatically terminated without notice if the parole of the entrepreneur has been terminated. This rule also finalizes the provision indicating that the decision to terminate parole may not be appealed, that USCIS will not consider a motion to reopen or reconsider a decision to terminate parole, and, upon its own motion, USCIS may reopen or reconsider a decision to terminate.
DHS also disagrees with the commenters' assertions that reforms should be made to the H-1B nonimmigrant classification and that the immigrant visa backlog should be addressed before this rule is finalized. Parole is an entirely separate option within the Secretary's authority to allow individuals to come to the United States on a case-by-case basis for urgent humanitarian reasons or significant public benefit. While DHS appreciates the commenters' sentiment that changes should be made in other contexts, the exact changes contemplated by the commenters are unclear, are outside the scope of this rulemaking, or would require congressional action.
DHS also disagrees with the assertion that taxpayer funds will be misallocated to process applications for parole under this final rule. Applicants for parole under this rule will be required to submit a filing fee to fully cover the cost of processing of applications.
The requirements governing eligibility for consideration for parole under this rule establish a high evidentiary bar that must be met in order to assist DHS in its determination that the individual will provide a significant public benefit to the United States. DHS, however, does not agree with the commenter's assertion that the requirements are impossible for all entrepreneurs to meet. Given that this is a new and complex process, DHS will consider potential modifications in the future after assessing the implementation of the rule and its impact on operational resources.
1.
While one commenter estimates that the eligible number of entrepreneurs will be higher than the DHS estimate, another commenter estimates it will be lower. Neither of the commenters provided a basis or data from which their figures were derived. DHS reaffirms that the estimate provided in this rule is reasonable. The assessment is based on analysis of data and publicly available information, and reflects, where data and analysis allow, reasonable medians or averages.
DHS also agrees with the commenter on impacts to intangible assets. Intangible assets are generally integrated into a firm's or sector's total assets and have become important in broad analyses of productivity and efficiency. Such assets can include proprietary software, patents, and various forms of research and development. This rule is intended to attract the types of ventures that will increase intangible assets.
In both the RFA and SBA's Guide for Government Agencies on the RFA, government agencies are required to consider significant alternatives to the rule when providing a full RFA analysis. Among the kinds of alternatives that SBA suggests considering include “the exemption for certain or all small entities from coverage of the rule, in whole or in part.”
The SBA also commented on various policy issues on the eligibility of entrepreneurs in this rule. Notwithstanding DHS' belief that entrepreneurs when filing for parole are not small entities, DHS has carefully considered all those comments and has made policy changes in this final rule to address the comments. Specifically, the SBA commented that thresholds to qualify for parole are directly tied to the ability of the international entrepreneur's start-up to produce significant public benefit for the United States. DHS has considered this comment along with other public comments on this issue and has made the decision to lower the eligible threshold investment amount for initial parole from the proposed $345,000 in the NPRM to $250,000 in the final rule. Additionally, in the NPRM and in this final rule, DHS has provided some flexibility and alternative criteria for those entrepreneurs meeting partial eligibility requirements, as described in further detail in the preamble.
SBA also commented that the rule only allows the entrepreneur to work for the business identified on the parole application without providing leniency in transferring the work authorization to another entity. The SBA further comments that the start-up entity may be imperiled if the entrepreneur is no longer eligible to stay in the United States. The eligibility criteria for consideration for parole under this rule require an entrepreneur to have recently formed a new entity in the United States with substantial potential for rapid growth and job creation. Before an application for parole under this rule is approved, USCIS must make a discretionary determination that the entrepreneur is well-positioned to provide a significant public benefit to the United States. Therefore, these eligibility criteria are not limiting entrepreneurs, but aimed at ensuring that only those entrepreneurs with high growth potential are eligible for parole consideration under this rule. DHS has also provided avenues for an additional parole period specifically to prevent instability of a start-up entity.
DHS reiterates that RFA guidance allows an agency to certify a rule, instead of preparing an analysis, if the rule is not expected to have a significant economic impact on a substantial number of small entities.
The Unfunded Mandates Reform Act of 1995 (UMRA) is intended, among other things, to curb the practice of imposing unfunded Federal mandates on State, local, and tribal governments. Title II of the Act requires each Federal agency to prepare a written statement assessing the effects of any Federal mandate in a proposed or final agency rule that may result in a $100 million or more expenditure (adjusted annually for inflation) in any one year by State, local, and tribal governments, in the aggregate, or by the private sector. The value equivalent of $100 million in 1995 adjusted for inflation to 2015 levels by the Consumer Price Index for All Urban Consumers (CPI-U) is $155 million.
This rule does not exceed the $100 million expenditure in any one year when adjusted for inflation ($155 million in 2015 dollars), and this rulemaking does not contain such a mandate. The requirements of Title II of the Act, therefore, do not apply, and DHS has not prepared a statement under the Act.
This rule is not a major rule as defined by section 804 of the Small Business Regulatory Enforcement Act of 1996. This rule will not result in an annual effect on the economy of $100 million or more, a major increase in costs or prices, or significant adverse effects on competition, employment, investment, productivity, innovation, or on the ability of United States companies to compete with foreign-based companies in domestic and export markets.
Executive Orders 12866 and 13563 direct agencies to assess the costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, distributive impacts, and equity). Executive Order 13563 emphasizes the importance of quantifying both costs and benefits, of reducing costs, of harmonizing rules, and of promoting flexibility. This rule has been designated a “significant regulatory action” under section 3(f) of Executive Order 12866. Accordingly, the rule has been reviewed by the Office of Management and Budget.
This final rule is intended to add new regulatory provisions guiding the use of parole with respect to individual international entrepreneurs who operate start-up entities and who can demonstrate through evidence of substantial and demonstrated potential for rapid business growth and job creation that they would provide a significant public benefit to the United States. Such potential is indicated by, among other things, the receipt of significant capital financing from U.S. investors with established records of successful investments, or obtaining significant awards or grants from certain Federal, State or local government entities. The regulatory amendments will provide the general criteria for considering requests for parole submitted by such entrepreneurs.
DHS assesses that this final rule will, by further implementing authority provided by Congress, reduce a barrier to entry for new innovative research and entrepreneurial activity in the U.S. economy.
Based on review of data on startup entities, foreign ownership trends, and Federal research grants, DHS expects that approximately 2,940 entrepreneurs, arising from 2,105 new firms with investment capital and about 835 new firms with Federal research grants, could be eligible for this parole program annually. This estimate assumes that each new firm is started by one person despite the possibility of up to three owners being associated with each start-up. DHS has not estimated the potential for increased demand for parole among foreign nationals who may obtain substantial investment from U.S. investors and otherwise qualify for entrepreneur parole, because changes in the global market for entrepreneurs, or other exogenous factors, could affect the eligible population. Therefore, these volume projections should be interpreted as a reasonable estimate of the eligible population based on past conditions extrapolated forward. Eligible foreign nationals who choose to apply for parole as an entrepreneur will incur the following costs: A filing fee for the Application for Entrepreneur Parole (Form I-941) in the amount of $1,200 to cover the processing costs for the application; a fee of $85 for biometrics submission; and the opportunity costs of time associated with completing the application and biometrics collection. After monetizing the expected opportunity costs and combining them with the filing fees, an eligible foreign national applying for parole as an entrepreneur will face a total cost of $1,591. Any subsequent renewals of the parole period will result in the same previously discussed costs. Filings to notify USCIS of material changes to the basis for the entrepreneur's parole, when required, will result in similar costs; specifically, in certain instances the entrepreneur will be required to submit to USCIS a new Form I-941 application to notify USCIS of such material changes and will thus bear the direct filing cost and concomitant opportunity cost. However, because the $85 biometrics fee will not be required with such filings, these costs will be slightly lower than those associated with the initial parole request and any request for re-parole.
Dependent spouses and children who seek parole to accompany or join the principal applicant by filing an Application for Travel Document (Form I-131), will be required to submit biographical information and biometrics as well. Based on a principal applicant population of 2,940 entrepreneurs, DHS assumes a total of 3,234 spouses and children will be eligible for parole under this rule. Each dependent will incur a filing fee of $575, a biometric processing fee of $85 (if 14 years of age and over) and the opportunity costs associated with completing the FormI-131 application and biometrics collection.
In each case in which an entrepreneur will be granted parole under this rule, DHS will have made a determination that parole will yield a significant public benefit and that the person requesting parole merits a favorable exercise of discretion. Consistent with those decisions, the rule is expected to produce broad economic benefits through the creation of new business ventures that otherwise would not be formed in the United States. These businesses are likely to create significant additional innovation, productivity, and job creation. It is reasonable to conclude that investment and research spending on new firms associated with this rule will directly and indirectly benefit the U.S. economy and create jobs for American workers. In addition, innovation and research and development spending are likely to generate new patents and new technologies, further enhancing innovation. Some portion of the international entrepreneurs likely to be attracted to this parole process may develop high-growth and high-impact firms that can be expected to contribute disproportionately to U.S. job creation. In summary, DHS anticipates that this rule will produce positive effects that would greatly exceed any negative consequences.
Using an estimate of 2,940 annual applications for significant public benefit entrepreneur parole as developed in the ensuing volume projections section of this analysis, DHS anticipates the total cost of this rule for principal filers who face a total per applicant cost of $1,591 to be $4,678,336 (undiscounted) annually for any given year. (These estimates focus only on principal initial filers, not entrepreneurs who might be eligible for a re-parole period of up to 30 months, or their spouses.) Dependent spouses and children who must submit the Form I-131 application and biometrics will face a per-applicant cost of $765, for a total cost of $2,474,914 (undiscounted). Dependent spouses who apply for employment authorization will face a per applicant cost of $446, which DHS projects will total $1,311,830 (undiscounted). Adding together the costs for the principal filers and family members—including filing costs, costs of submitting biometrics, and monetized opportunity costs—yields a total cost of this rule for the first year, 2017 and subsequently 2018, of $8,465,080 (undiscounted). The total annual cost of the rule of $8,465,080 can be expected for each subsequent year in the ten-year period. The total ten-year undiscounted cost is $84,650,081.
Section 212(d)(5) of the Immigration and Nationality Act (INA), 8 U.S.C. 1182(d)(5), grants the Secretary of Homeland Security the discretionary authority to parole applicants for admission into the United States temporarily, on a case-by-case basis, for urgent humanitarian reasons or significant public benefit. DHS is amending its regulations implementing this authority to increase and enhance entrepreneurship, research and development and other forms of innovation, and job creation in the United States. The rule will establish general criteria for the use of parole with respect to individual entrepreneurs who operate start-up entities and who can demonstrate through evidence of substantial and demonstrated potential for rapid business growth and job creation that they would provide a significant public benefit to the United States.
The purpose of the rule is to attract talented entrepreneurs to the United States who might otherwise choose to pursue such innovative activities abroad, or otherwise be significantly delayed in growing their companies in the United States, given the barriers they presently face. In addition to the benefits associated with entrepreneurial innovation, including new products, business networks, and production efficiencies that such activities are likely to generate, entrepreneurs have been and remain vital to economic growth and job creation in the United States and have generated a cohort of high-growth firms that have driven a highly disproportionate share of net new job creation.
A body of research documents both the importance of entrepreneurial activity to the U.S. economy and its link to immigration. In this background section, DHS does not attempt to comprehensively summarize this large body of work but instead focuses on specific aspects central to the purpose of the rule and to its potential impacts.
The labor market of the United States is highly dynamic. DHS analysis of data published by the U.S. Department of Labor's Bureau of Labor Statistics (BLS) indicates that between 2004 and 2013, on average about 847,000 firms were “born” each year and 784,000 “died.”
This rule focuses on identifying entrepreneurs associated with types of start-up firms that are more likely to experience high growth, contribute to innovation, and create jobs in the United States. This deliberate focus is critical to ensuring that parole in individual cases is justified by significant public benefit. Research has shown that the average start-up company does not survive long.
There is significant research, however, demonstrating that a small subset of new firms tends to be highly dynamic and to contribute disproportionately to net job creation. The BLS has highlighted the role of the small subset of high-growth firms that comprise about 2 percent of all firms but have accounted for 35 percent of gross job gains in recent years. “High-growth firms” are defined by the BLS and the Organization for Economic Cooperation (OECD) as those with at least ten employees that grow by at least 20 percent for each of 3 consecutive years based on employment. As of 2012, there were 96,900 high-growth firms in the United States that had created about 4.2 million jobs.
This highly disproportionate, “up or out” dynamism of high-growth firms has been substantiated by many researchers. The SBA reported that about 350,000 “high impact firms”—defined as enterprises whose sales have at least doubled over a 4-year period and which have an employment growth quantifier of 2 or more over the same period—generated almost all net new jobs in the United States between 1994 and 2006.
Despite the finding across a large number of studies that small new firms tend to exhibit an “up or out” dynamic in which a small number survive to age five to become high-growth firms or “gazelles,” other key findings that have emerged in the literature suggest that the growth and performance of new firms, even high-growth firms, vary substantially (as indicated by metrics that include labor productivity, profitability, revenue, and research and development intensity).
Broadly speaking, high-growth entrepreneurs engage in research and development (R&D) in order to develop and commercialize new products and technologies. Several studies have found that such entrepreneurs tend to engage in R&D spending in the first year, tend to attract patents and other forms of intellectual capital, and tend to attract venture capital financing.
Immigrants have been central contributors to business ownership and entrepreneurship in the United States and abroad. According to OECD data, self-employment rates for immigrants are higher than those of the native-born populations in many counties, including in the United States.
Many high-growth firms are involved in activities classified in the STEM (science, technology, engineering, and math) fields. The high concentration of immigrant entrepreneurs in these industries has garnered much attention. Between 2006 and 2012, one-third of companies financed with venture capital that made an initial public offering had an immigrant founder, a sharp rise from seven percent in 1980. These companies have generated 66,000 jobs and $17 billion in sales.
Further evidence points to similar findings. Between 1995 and 2005, 25 percent of science and technology focused businesses founded in the United States had a foreign-born chief executive or lead technologist. In 2005, those companies generated $52 billion in sales revenue and employed 450,000 workers. In Silicon Valley, the share of immigrant-founded start-ups increased to 52 percent by 2005. In 2006, foreign nationals residing in the United States were involved (as inventors or co-inventors) in about 26 percent of patent applications filed that year. Immigrant founders of Silicon Valley firms tend to be highly educated, with 96 percent holding bachelor's degrees and 74 percent holding advanced degrees, and with three-quarters of the latter in STEM fields. As of 2010, according to one study, more than 40 percent of the Fortune 500 companies had been founded by an immigrant or the child of an immigrant.
To reiterate, high-growth firms tend to be new and young, and one of their primary contributions to the highly dynamic labor market of the United States has been through job creation. High-growth firms tend to innovate and focus on developing new products and services. The intense involvement of immigrant entrepreneurs in successful technology-driven activities suggests substantial economic contributions. While measuring the precise value and impact of innovation is difficult and still at a nascent stage in research, many economists believe innovation creates positive externalities and spillover effects that further drive economic growth.
Notwithstanding the research on the positive effects of high-growth entrepreneurship, there is some evidence of a long-term slowing in start-up dynamism and entrepreneurial activity in the United States; this trend began several decades ago, driving many economists to advocate for policies that attract more entrepreneurs in general.
DHS cannot precisely predict the volume of new businesses that will start in the United States due to this rule. DHS has instead examined available data to provide a broad estimate of the population of individual entrepreneurs who may be eligible to request parole consideration under this rule. Given limits on DHS's information about such entrepreneurs, DHS does not know how many people within the estimated eligible population will actually seek such consideration; the estimates contained in this section represent an approximation to the size of the eligible population. DHS has estimated the population of entrepreneurs potentially eligible for parole under this rule based on two sub-groups: (1) Foreign individuals who seek to come to the United States to start a new business with financial backing from a qualified U.S. investor; and (2) foreign individuals who seek to come to the United States to start a new business as recipients of U.S. funded and awarded
DHS has no way of predicting with certainty the actual number of foreign nationals who will seek parole under this rule over time, as the size of the eligible population could change significantly. DHS acknowledges that the estimate of eligible individuals annually is an approximation based on past foreign ownership and start-up capital amounts. The analysis utilized to estimate the potential eligible population is also based implicitly on assumptions that: (1) The rule will not significantly change the frequency of U.S. funded grant applications from international researchers; and (2) that the rule will not significantly affect the market for international entrepreneurs and the market for the types of investment structures the rule will involve. Based on these assumptions and the data limitations, DHS projects that for the first full year that the rule will be effective, annual eligibility will be approximately 2,940.
Because U.S.-funded research grants may be a qualifying investment under this rule, DHS obtained publicly available data on federally funded grants for fiscal years 2013-2015.
To estimate the number of potential new entrepreneurial start-ups, DHS obtained and analyzed data from the BLS and the Census Bureau. From the BLS Business Employment Dynamics (BED) data suite, DHS obtained the number of private establishments aged 1 year or less for nine broad sectors likely to be involved in innovative activity, in order to focus on entrants.
For each sector, DHS obtained the corresponding share of firms owned by a person “not born a citizen of the United States” from the Census Bureau's Survey of Business Owners data set.
Next, DHS attempted to calculate how many of the firms were started with at least $250,000, the minimum investment threshold that the rule sets. The SBO data provides ranges of such startup capital amounts but DHS could not conduct a precise estimate because the data do not provide a category bound by the threshold minimum. In fact, the encompassing tranche is very large, from $249,500 to $1 million in range. The SBO does not provide actual cohort data or other information from which DHS could evaluate the distribution and, therefore, DHS has no way of ascertaining how many firms in this large range will occupy the $250,000 to $1 million segment. As a result, DHS relied on the share of firms in this tranche and the additional tranches over $1,000,000 relative to the share of all firms reporting for the sector, and recognizes that the volume projection is likely larger than is realistic. An additional assumption is that the startup threshold is the same for businesses with native and foreign-born founders. The relevant data and estimates per sector are shown in Table 2.
As is discussed in the preamble, DHS has revised two substantive components of the eligibility criteria for this final rule. Foremost, the general investment amount requirement has been lowered from $345,000 to $250,000. DHS believes that the volume estimate of entrepreneurs based on investment capital will be higher than the 2,105 presented above but cannot make a determination of exactly how much higher. The reason is that the lower investment amount will allow some firms to be created that otherwise would not at the higher amount proposed initially, but the Census Bureau capital size bin relevant to the level proposed is the $249,500 to $1 million in range, which includes both figures. Because DHS does not have data on the distribution of amounts within this range, the entire bin was included in the proposed estimates and is retained in the final estimates. However, as is described below, DHS has conducted an alternative method of estimation—to include updates from the initial proposal based on new information and data—that compares very closely to the estimated total volume of 2,940. Specifically, an alternative estimate of total volume annually is 2,920.
DHS recognizes the imperfections in estimating the potential population of eligible entrepreneurs based on extrapolating past conditions of foreign ownership rates and capital thresholds. The main benefit of this method is that it is based on official data. A main limitation is that it assumes that the annual crop of firms created are entrepreneurial and the types of firms covered by the parole process in the rule. In practice, some, but not all, will
DHS obtained publicly available information from Seed-DB, which provides data on U.S. accelerators collected from industry associations and fee-based data providers such as Crunchbase, which is a large data provider for venture capital, angel investors, and accelerators.
This estimate compares well to the official total volume estimate of 2,940. The accelerator data captures seed rounds that involve venture capital, angel, accelerator investments, and grants, which is why it is compared to the total volume estimate.
This section discusses several potential cohorts involving entrepreneurial activity that is difficult to estimate.
In light of the potential benefits to the U.S. economy and job creation, DHS is proposing this rule to provide a mechanism that, consistent with the requirements of the INA, encourages international entrepreneurs described herein to form and create innovative firms in the United States. In 2011, DHS began outreach and stood up the Entrepreneurs in Residence initiative to try to encourage entrepreneurship among foreign nationals.
In addition, the rule lists a number of ancillary conditions for eligibility—and conversely a number of conditions that
Finally, two potential elements of the eligible population are considered. First, as alluded to in the summary, the volume estimates and ensuing cost estimates assume one individual owner for each new firm; under the rule, DHS will allow up to three individuals per firm to seek parole but does not attempt to estimate how many of the startups could have more than one owner. Second, the volume estimate for grants is based on Federal awards only. DHS will consider eligibility based on State or local grants and awards, including those from State or local Economic Development Corporations (EDCs). However, unlike in the case of Federal awards, there is not a database capturing State and local grants or the transmission mechanisms through which some Federal grants are distributed to other entities, such as EDCs, and as such DHS was unable to estimate the number of entrepreneurs potentially eligible for parole as a result of receiving State and local grants.
A. Principal Filer Costs
The rule will permit certain foreign nationals to apply for a 30-month (2.5-year) initial period of parole into the United States provided they meet the eligibility criteria. Those who seek such parole into the United States will face the costs associated with the application, which involve a $1,200 application fee plus other costs, detailed below. The costs will stem from filing fees and the opportunity costs of time associated with filing the Application for Entrepreneur Parole (Form I-941).
The filing fee for the Form I-941 application is $1,200. The fee is set at a level intended to recover the anticipated processing costs to DHS.
DHS estimates that the application will take 4.7 hours to complete. After DHS receives the application and fees, if the applicant is physically present in the United States, USCIS will send the applicant a notice scheduling him or her to visit a USCIS Application Support Center (ASC) for biometrics collection. Along with the $85 biometric services fee, the applicant will incur the following costs to comply with the biometrics submission requirement: the opportunity cost of traveling to an ASC, the mileage cost of traveling to an ASC, and the opportunity cost of time for submitting his or her biometrics. While travel times and distances vary, DHS estimates that an applicant's average roundtrip distance to an ASC is 50 miles, and that the average time for that trip is 2.5 hours. DHS estimates that an applicant waits an average of 1.17 hours for service and to have his or her biometrics collected at an ASC, adding up to a total biometrics-related time burden of 3.67 hours.
DHS estimates that each principal parole applicant will incur the following costs: $1,285 in filing fees to cover the processing costs for the application and biometrics; $306.27 after summing the monetized cost of travel to submit biometrics, the total opportunity costs of time of the initial applications, biometrics, and estimated travel costs, resulting in a total cost of $1,591.27 per application, rounded to $1,591.
The rule will require all dependent family members (spouses and children) accompanying or joining the entrepreneur to file an Application for Travel Document (Form I-131), and will require all spouses and children 14 years of age through age 79 to submit biometrics.
DHS will require dependents of parole applicants (spouses and children of the parole applicant) to file an Application for Travel Document (Form I-131). There is a $575 filing fee associated with the Form I-131 application, and DHS estimates it will take 3.56 hours to complete each submission. In addition to filing the Form I-131 application, each dependent spouse and child 14 years of age and over will be required to submit biometric information (fingerprints, photograph, and signature) by attending a biometrics services appointment at a designated USCIS Application Support Center (ASC). The biometrics processing fee is $85.00 per applicant. In addition to the $85 biometrics services fee, the applicant will incur the following costs to comply with the biometrics submission requirement: the opportunity and mileage costs of traveling to an ASC, and the opportunity cost of submitting his or her biometrics. While travel times and distances vary, DHS estimates that an applicant's average roundtrip distance to an ASC is 50 miles, and that the average time for that trip is 2.5 hours.
DHS projects that approximately 3,234 dependents will be required to file a Form I-131 application and submit biometrics, based on the estimate of 2,940 principal applicants and using a multiplier for expected family members of 1.1.
In addition, DHS is allowing independent employment authorization for spouses of entrepreneurs granted parole under this rule. DHS will permit these individuals to apply for employment authorization by filing a Form I-765 application. To estimate the number of potential persons applying for employment authorization, DHS used a simple one-to-one mapping of entrepreneurs to spouses to obtain 2,940 spouses, the same number as entrepreneur parolees.
The current filing fee for the Form I-765 application is $410.00. The fee is set at a level to recover the processing costs to DHS. Based on the projection of 2,940 applicants, the total filing cost is $1,205,400 (undiscounted). DHS estimates the time burden of completing the Form I-765 application is 3.42 hours.
In addition to the filing costs, applicants for parole may face other costs associated with their entrepreneurial activities. These could include the administrative costs of starting up a business, applying for grants, obtaining various types of licenses and permits, and pursuing qualified investments. However, these costs apply to the entrepreneurial activity and the business activity that the applicant has chosen to be involved in and are not driven by the parole process or other governmental functions attributable to the rule itself. Hence, DHS does not attempt to estimate, quantify, or monetize such costs.
Lastly, DHS recognizes that some individuals who were lawfully admitted in the United States in certain nonimmigrant classifications may seek
DHS does not expect the rule to generate significant costs or negative consequences. Extensive review of information relevant to immigrant entrepreneurship indicates that while much about the impact of such entrepreneurship is not known, there is no reason to expect that substantial negative consequences, including adverse impact on domestic workers, are likely. The possibility that immigrant entrepreneurs may displace (“crowd-out”) native entrepreneurs has been raised by a few researchers. One study indicated that a very small number of native entrepreneurs were possibly displaced by immigrant entrepreneurs.
DHS recognizes that the potential inclusion of spouses can incur labor market implications and possibly impact U.S. workers. As was noted in previous sections of the regulatory impact analysis, DHS did not attempt to assess or measure the labor market impact of the estimated entrepreneurs potentially eligible for parole because as founders of firms, these persons will not affect the labor market in the same way as other workers. Although spouses could have labor market impacts as new labor market entrants, DHS believes such potential impacts will be negligible. The main reason is that the size of the potential new cohort is very small. As of the end of 2015, there were an estimated 157,130,000 people in the U.S. civilian labor force.
While the figures above apply to the general U.S. labor force, DHS recognizes that concentration of new labor force entrants can impact specific labor markets. DHS believes that any such potential impacts linked to this rule will be insignificant. The NVCA and other sources of information that DHS reviewed indicates that while the area of California known as Silicon Valley has traditionally been, and continues to be, the primary recipient geographically for technology startup capital, other large urban centers on the East Coast and, even more recently, parts of the Mid- and Mountain West have seen increased technology startup activity. To provide just one example of a potential area-specific impact, DHS considered the San Jose-San Francisco-Oakland (CA) Combined Statistical Area (CSA) conjoining the seven Metropolitan Statistical Areas (MSAs) and nine encompassed counties constituting the economic linkages of Silicon Valley. Based on data from the BLS, the population of this CSA is about 8.6 million (as of May 2014) and the employed population (a narrower measure of the labor market than the labor force) about 3.75 million. If the share of new entrants is based on the proportion of venture capital to the area, which is 42 percent, then 2,746 spousal entrants could impact the area.
The INA provides for the collection of fees at a level that will ensure recovery of the full costs of providing services, including administrative costs and services provided without charge to certain applicants and petitioners.
As referenced previously, evidence suggests that innovation-focused start-ups contribute disproportionately to job creation. The rule will reduce entry barriers, and thus support efforts by international entrepreneurs to generate entrepreneurial activity in the United States.
The rule is expected to generate important net benefits to the U.S. economy. For one, expenditures on research and development by the grant-based researchers that DHS has identified that could qualify for entrepreneur parole will generate direct and indirect jobs. In addition, this research-focused spending could potentially generate patents, intellectual property, licensing, and other intangible assets that can be expected to contribute to innovation and technological advances and spill over into other sectors of the overall economy. DHS acknowledges that it is extremely difficult to gauge the precise economic value of such assets and that peer-reviewed research in this area is still nascent. Despite the nascent stage of the research and the difficulty of measuring quantitatively the benefit of innovation driven by new high technology firms, a large body of research indicates that the innovation driven by entrepreneurs contributes directly to economic growth, generates important efficiencies and cost reductions for firms that utilize such innovation, and increases productivity and profitability for firms that benefit indirectly through new products generated by such innovation.
Lastly, DHS believes that many of the start-up firms operated by international entrepreneurs during the parole period could eventually become high-growth firms that generate exceptionally high levels of economic activity and contribute disproportionately to job creation in the United States.
In accordance with the Regulatory Flexibility Act (RFA), 5 U.S.C. 601(6), DHS examined the impact of this rule on small entities. A small entity may be a small business (defined as any independently owned and operated business not dominant in its field that qualifies as a small business per the Small Business Act, 15 U.S.C. 632), a small not-for-profit organization, or a small governmental jurisdiction (locality with fewer than 50,000 people).
In the proposed rule, DHS certified that this rule would not have a significant impact on a substantial number of small entities. DHS made this determination based on the following facts: This is not a mandatory rule; this rule only impacts those individual entrepreneurs who make the voluntary decision to apply for parole; and this rule does not regulate the business entities in any way. After reviewing public comments, including the formal letter submitted on the record by the U.S. Small Business Administration's Office of Advocacy (Advocacy), DHS maintains its certification that the rule does impose a significant impact on a substantial number of small entities. For a full discussion of the DHS response to the letter submitted by Advocacy, please see Section III.M.4 of this preamble.
Individuals are not defined as a “small entity” by the RFA. The rule will not mandate that all individuals apply for parole. This rule provides flexibilities and options that do not currently exist for individuals who wish to establish or operate a start-up business in the United States. Importantly, the rule does not require any individuals or businesses, including those created by foreign nationals, to seek parole—either generally or as a specific condition for establishing or operating a business in the United States. Rather, as mentioned previously, this rule is intended to provide an additional flexibility for foreign individuals who are unable to obtain another appropriate nonimmigrant or immigrant classification, in order to facilitate the applicant's ability to oversee and grow the start-up entity. If any individual believes this rule imposes a significant economic impact, that individual could simply choose not to seek parole under the rule and thus incur no economic impact. As discussed previously, this rule imposes direct filing costs of $1,285 (which includes the $1,200 application fee and the $85 biometrics fee), plus $194 in time-related opportunity costs for those individuals who do choose to apply for parole as entrepreneurs under the rule. This cost is relatively minor when considering the costs of starting up a new business and the capital necessary to start a business.
Under the general term “entrepreneur,” DHS includes those who desire to form firms with investment funds from certain U.S. investors. For purposes of the RFA, the regulatory requirements place compliance costs and establish eligibility criteria for the individual requesting consideration for parole under this rule. DHS believes that the costs of application for parole will burden the individual applicant, and not the entrepreneurial venture (firm). This rule will not alter or change the normal procedure for fundraising or other start-up administrative costs that occur in forming a business entity. Such costs are not direct costs of this rule and could include, but are not limited to, business application fees, legal fees, and licensing that precede significant infusions of investment, the latter of which are primarily utilized for operational and capital expenses in order to produce goods or services.
It is possible that some of the 2,940 estimated entrepreneurs who could be eligible for parole annually could involve business structures in which the filing fees are paid by a business entity. In the event that small business entities are impacted by this rule because they choose to pay the filing fees on behalf of an individual entrepreneur, DHS believes that the filing cost of $1,285 per application will be insignificant compared to such entities' annual gross revenues, potential for revenue, and other economic activity.
For businesses that may pay the filing costs, the expected impact to such businesses will be small. For businesses that utilize either the minimum threshold of $100,000 for a qualifying government grant or award or $250,000 in capital investment to source the filing costs, such costs will constitute 1.3 percent and 0.4 percent, respectively, of the total capital amount. These relatively low cost proportions apply to those firms that only obtain the minimum investment amounts and have no other source of funding or revenues. In addition, DHS analyzed the cost impact relative to more typical RFA indices. DHS analysis of Census Bureau data on the smallest firms found that the average revenue based on sales receipts for firms with no paid employees is $309,000, while the average for firms with one to four paid employees is $411,000.
DHS also analyzed the average revenue for new firms. Since the rule defines a new firm as one that is less than five years old at the time the initial parole application is filed, DHS grouped private sector firms for the 2012 survey as those responding that the year of
In summary, DHS believes that per-applicant costs will be primarily incurred by the individual (which is not covered by the RFA), any direct cost due to this rule will be relatively minor, and these costs will only be borne by those who voluntarily choose to apply for parole under this rule. While the applicant for parole may be the owner of a firm that could be considered small within the definition of small entities established by 5 U.S.C. 601(6), DHS considers the applicants to be individuals at the point in time they are applying for parole, particularly since it is the individual and not the entity that files the application and it is the individual whose parole must provide a significant public benefit under this rule. Furthermore, even if firms do voluntarily decide to incur the compliance costs on behalf of the individual requesting consideration for parole under this rule, the only compliance costs those businesses will be permitted to incur will be the filing costs for the applications. As indicated previously, based on the comparison metric used, those costs are expected to be insignificant.
Based on the evidence presented in this RFA section and throughout this preamble, DHS certifies that this rule will not have a significant economic impact on a substantial number of small entities.
DHS Directive (Dir) 023-01 Rev. 01 establishes the procedures that DHS and its components use to comply with NEPA and the Council on Environmental Quality (CEQ) regulations for implementing NEPA. 40 CFR parts 1500 through 1508.
The CEQ regulations allow federal agencies to establish, with CEQ review and concurrence, categories of actions (“categorical exclusions”) which experience has shown do not individually or cumulatively have a significant effect on the human environment and, therefore, do not require an Environmental Assessment (EA) or Environmental Impact Statement (EIS). 40 CFR 1507.3(b)(1)(iii), 1508.4. DHS Directive 023-01 Rev. 01 establishes Categorical Exclusions that DHS has found to have no such effect. Dir. 023-01 Rev. 01 Appendix A Table 1. For an action to be categorically excluded, DHS Directive 023-01 Rev. 01 requires the action to satisfy each of the following three conditions: (1) The entire action clearly fits within one or more of the Categorical Exclusions; (2) the action is not a piece of a larger action; and (3) no extraordinary circumstances exist that create the potential for a significant environmental effect. Dir. 023-01 Rev. 01 section V.B (1)-(3).
DHS analyzed this action and does not consider it to significantly affect the quality of the human environment. This rule provides criteria and procedures for applying the Secretary's existing statutory parole authority to entrepreneurs in a manner to assure consistency in case-by-case adjudications. DHS has determined that this rule does not individually or cumulatively have a significant effect on the human environment because it fits within two categorical exclusions under DHS Directive 023- 01 Rev. 01, Appendix A, Table 1. Specifically, the rule fits within Categorical Exclusion number A3(a) for rules strictly of an administrative or procedural nature and A3(d) for rules that interpret or amend an existing regulation without changing its environmental effect.
This rule is not part of a larger action and presents no extraordinary circumstances creating the potential for significant environmental effects. Fewer than 3,000 individuals, an insignificant number in the context of the population of the United States, are projected to receive parole through this program. Furthermore, any ventures will be governed by local, state and federal laws and regulations, including those protecting the human health and the environment. Therefore, this rule is categorically excluded from further NEPA review.
This rule will not have substantial direct effects on the States, on the relationship between the National Government and the States, or on the distribution of power and responsibilities among the various levels of government. Therefore, in accordance with section 6 of Executive Order 13132, it is determined that this rule does not have sufficient federalism implications to warrant the preparation of a federalism summary impact statement.
This rule meets the applicable standards set forth in sections 3(a) and 3(b)(2) of Executive Order 12988.
Under the Paperwork Reduction Act of 1995 (PRA), Public Law 104-13, all Departments are required to submit to the Office of Management and Budget (OMB), for review and approval, any reporting requirements inherent in a rule.
This final rule requires that an applicant requesting entrepreneur parole complete an Application for Entrepreneur Parole, Form I-941, and is considered a new information collection under the PRA. USCIS did receive one comment regarding the time burden of this form and, upon review of the work involved to review the form, gather necessary information to support the submission, and the time required to complete and submit the form, USCIS has revised the estimated hour burden per response to 4.7 hours.
a.
b.
c.
d.
e.
f.
g.
h.
DHS is revising this collection by including spouses and children seeking parole on the basis of an entrepreneur parolee.
In addition to revising the form and form instructions, DHS is revising the estimate of total burden hours has increased due to the addition of this new population of Application for Travel Document, Form I-131, filers, and the increase of burden hours associated with the collection of biometrics from these applicants.
a.
b.
c.
d.
e.
f.
The total number of respondents includes the additional population of 3,234 individuals as estimated previously in the analysis in Section IV.C.
g.
h.
In accordance with new 8 CFR 274a.2(b)(1)(v)(A)(
a.
b.
c.
d.
e.
f.
g.
• Time Burden for Employees—20 minutes (.33 hours) total;
• Time Burden for Employers—10 minutes (.17 hours) total;
• Time Burden for Recordkeeping—5 minutes (.08 hours) total
h.
DHS is making minor revisions to the form instructions to reflect changes made by this final rule that allow spouses of an entrepreneur parolee to request employment authorization.
a.
b.
This form was developed for individual aliens to request employment authorization and evidence of that employment authorization. The form is being amended to add a new class of aliens eligible to apply for employment authorization, specifically a spouse of an entrepreneur parolee described as eligible for employment authorization under this rule. Supporting documentation demonstrating eligibility must be filed with the application. The form lists examples of relevant documentation.
c.
d.
e.
f.
This total represents the aggregate estimate for this information collection, to include the additional estimate of 2,940 respondents under this rule.
g.
h.
DHS adopted most of the proposed regulatory amendments without change.
Administrative practice and procedure, Authority delegations (Government agencies), Freedom of information, Immigration, Privacy, Reporting and recordkeeping requirements.
Administrative practice and procedure, Aliens, Immigration, Passports and visas, Reporting and recordkeeping requirements.
Administrative practice and procedure, Aliens, Employment, Penalties, Reporting and recordkeeping requirements.
Accordingly, DHS amends chapter I of title 8 of the Code of Federal Regulations as follows:
5 U.S.C. 301, 552, 552a; 8 U.S.C. 1101, 1103, 1304, 1356, 1365b; 31 U.S.C. 9701; Pub. L. 107-296, 116 Stat. 2135 (6 U.S.C. 1
(b) * * *
(1) * * *
(i) * * *
(KKK)
6 U.S.C. 111, 202(4) and 271; 8 U.S.C. 1101 and note, 1102, 1103, 1182 and note, 1184, 1185 note (section 7209 of Pub. L. 108-458), 1187, 1223, 1225, 1226, 1227, 1255, 1359; 8 CFR part 2.
Section 212.1(q) also issued under section 702, Pub. L. 110-229, 122 Stat. 754, 854.
(a)
(1)
(2)
(3)
(4)
(5)
(i) The individual or organization made investments in start-up entities in exchange for equity, convertible debt or other security convertible into equity commonly used in financing transactions within their respective industries comprising a total in such 5-year period of no less than $600,000; and
(ii) Subsequent to such investment by such individual or organization, at least 2 such entities each created at least 5 qualified jobs or generated at least $500,000 in revenue with average annualized revenue growth of at least 20 percent.
(6)
(7)
(8)
(9)
(10)
(b)
(2)
(ii)
(A) Demonstrating that the alien is an entrepreneur as defined in paragraph (a)(1) of this section and that his or her entity is a start-up entity as defined in paragraph (a)(2) of this section; and
(B) Establishing that the alien's entity has:
(
(
(iii)
(c)
(2)
(ii)
(A) Demonstrating that the alien continues to be an entrepreneur as defined in paragraph (a)(1) of this section and that his or her entity continues to be a start-up entity as defined in paragraph (a)(2) of this section; and
(B) Establishing that the alien's entity has:
(
(
(
(iii)
(d)
(2)
(3)
(4)
(e)
(f)
(g)
(h)
(2) The spouse and children of an entrepreneur granted parole under this section may be granted parole under this section for no longer than the period of parole granted to such entrepreneur.
(3) The spouse of the entrepreneur parolee, after being paroled into the United States, may be eligible for employment authorization on the basis of parole under this section. To request employment authorization, an eligible spouse paroled into the United States must file an Application for Employment Authorization (Form I-765), in accordance with 8 CFR 274a.13 and form instructions. An Application for Employment Authorization must be accompanied by documentary evidence establishing eligibility, including evidence of the spousal relationship.
(4) Notwithstanding 8 CFR 274a.12(c)(11), a child of the entrepreneur parolee may not be authorized for and may not accept employment on the basis of parole under this section.
(i)
(j)
(k)
(2)
(3)
(i) The facts or information contained in the request for parole were not true and accurate;
(ii) The alien failed to timely file or otherwise comply with the material change reporting requirements in this section;
(iii) The entrepreneur parolee is no longer employed in a central and active role by the start-up entity or ceases to possess a qualifying ownership stake in the start-up entity;
(iv) The alien otherwise violated the terms and conditions of parole; or
(v) Parole was erroneously granted.
(4)
(l)
8 U.S.C. 1101, 1103, 1324a; 48 U.S.C. 1806; 8 CFR part 2; Pub. L. 101-410, 104 Stat. 890, as amended by Pub. L. 114-74, 129 Stat. 599.
The revisions read as follows:
(b) * * *
(1) * * *
(v) * * *
(A) * * *
(
(C) * * *
(
The revisions and additions read as follows:
(b)
(37) An alien paroled into the United States as an entrepreneur pursuant to 8 CFR 212.19 for the period of authorized parole. An entrepreneur who has timely filed a non-frivolous application requesting re-parole with respect to the same start-up entity in accordance with 8 CFR 212.19 prior to the expiration of his or her parole, but whose authorized parole period expires during the pendency of such application, is authorized to continue employment with the same start-up entity for a period not to exceed 240 days beginning on the date of expiration of parole. Such authorization shall be subject to any conditions and limitations on such expired parole. If DHS adjudicates the application prior to the expiration of this 240-day period and denies the application for re-parole, the employment authorization under this paragraph shall automatically terminate upon notification to the alien of the denial decision.
(c) * * *
(11) Except as provided in paragraphs (b)(37) and (c)(34) of this section and § 212.19(h)(4) of this chapter, an alien paroled into the United States temporarily for urgent humanitarian reasons or significant public benefit pursuant to section 212(d)(5) of the Act.
(34) A spouse of an entrepreneur parolee described as eligible for employment authorization in § 212.19(h)(3) of this chapter.
Federal Motor Carrier Safety Administration (FMCSA), DOT.
Final rule; suspension of effective date and temporary final rule.
The FMCSA suspends its regulations requiring existing interstate motor carriers, freight forwarders, brokers, intermodal equipment providers (IEPs), hazardous materials safety permit (HMSP) applicants, and cargo tank facilities under FMCSA jurisdiction to submit required registration and biennial update information to the Agency via a new electronic on-line Unified Registration System (URS). During this suspension, entities needing to file will follow the same procedures and forms used to submit information to FMCSA as they do today.
Petitions for reconsideration must be submitted to: Administrator, Federal Motor Carrier Safety Administration, 1200 New Jersey Avenue SE., Washington, DC 20590-0001.
All background documents, comments, and materials related to this rule may be viewed in docket number FMCSA-1997-2349 using either of the following methods:
•
• Docket Management Facility (M-30), U.S. Department of Transportation, West Building Ground Floor, Room W12-140, 1200 New Jersey Avenue SE., Washington, DC 20590-0001.
Mr. Kenneth Riddle, 1200 New Jersey Avenue SE., Washington, DC 20590-0001, by telephone at (202) 366-9616 or via email at
To view comments, as well as documents identified in this preamble as available in the docket, go to
All comments received are posted without change to
This final rule is being issued to further delay the effective and compliance dates of the Unified Registration System final rule (URS 1 final rule), issued on August 23, 2013 and revised as noted below in the Regulatory History section. The URS 1 final rule was issued to improve the registration process for motor carriers, property brokers, freight forwarders, Intermodal Equipment Providers (IEPs), hazardous materials safety permit (HMSP) applicants, and cargo tank facilities required to register with FMCSA, and streamline the existing Federal registration processes to ensure the Agency can more efficiently track these entities. FMCSA is extending the implementation date of the final stage of the URS 1 final rule beyond January 14, 2017 because additional time is needed to securely migrate data from multiple legacy platforms into a new central database and to conduct further compatibility testing with its State partners. The Agency recently migrated its information technology systems to a “cloud” environment. This migration effort was a necessary step in order to provide a foundation to successfully implement URS.
By moving the implementation date, FMCSA is providing its State partners more time to develop, update, and verify data connectivity and system reliability. The additional time will also enable the Agency to conduct more thorough training and to implement broader outreach and education activities that will provide for a seamless transition.
Due to the numerous revisions and corrections that have been made to the URS 1 final rule, FMCSA, in consultation with the Office of the Federal Register (OFR), is allowing the URS 1 rule to come into effect, immediately suspending it, and replacing it with temporary regulations. FMCSA intends to lift the suspension once the technology to implement URS 1 is complete, and effectively replace the temporary regulations with the URS 1 final rule, as issued on August 23, 2013. FMCSA and the OFR have determined that this procedure will result in a compilation of rules that is relatively easy to understand and follow. The temporary provisions read almost exactly as the regulations in existence on January 13, 2017 (the day before URS 1 becomes effective). Their only differences are the “T” notation in their section designation, which denotes them as temporary provisions within the Code of Federal Regulations, and new paragraph designations in some cases, to align with current guidelines for publication in the CFR.
FMCSA relies upon the same legal authority cited in the August 23, 2013, Unified Registration System final rule (URS 1).
The Administrative Procedure Act (APA) (5 U.S.C. 551- 706) specifically provides exceptions to its notice and public comment rulemaking requirements where the Agency finds there is good cause (and incorporates the finding and a brief statement of reasons therefore in the rules issued) to dispense with them. Generally, good cause exists where the Agency determines that notice and public procedures are impractical, unnecessary, or contrary to the public interest (5 U.S.C. 553(b)(3)(B)). This URS final rule is being issued to, in effect, delay the effective date of the original URS 1 final rule. FMCSA will not have the technological ability to support the changes made by the August 23, 2013, final rule by the final rule's current effective date (January 14, 2017), which would make it impossible for motor carriers to comply with the regulations. If FMCSA does not suspend these regulations and replace them with temporary provisions, existing motor carriers would find themselves unable to obtain a USDOT number, request additional registration, or file evidence of meeting financial responsibility requirements, among other things. The motor carrier registration process would grind to a halt, likely posing significant harm to motor carriers, other FMCSA-regulated entities, drivers, and those who use their services. For these reasons, FMCSA finds good cause to dispense with notice and public comment on this final rule, as providing for public notice and comment would be contrary to the public interest.
For these same reasons, and also pursuant to the APA (5 U.S.C. 553 (d)(3)), this final rule will be effective on January 14, 2017. Delaying the effective date for 30 days after publication would result in the URS 1 rule remaining in effect, causing the same complications described above.
The Federal Highway Administration (FMCSA's predecessor agency) issued an advance notice of proposed rulemaking (ANPRM), announcing plans to develop a single, online, Federal information system in August 1996.
On May 19, 2005, FMCSA published an NPRM describing a proposal to merge all of the prescribed information systems except the Single State Registration System (SSRS) into a unified, online Federal system.
On October 21, 2015, FMCSA published a final rule delaying the URS 1 effective date until September 30, 2016.
This rule amends 49 CFR part 360 in reference to fees; part 365 procedures governing applications for operating authority and transfers of operating authority; part 366 procedures for designations of process agents; part 368 procedures governing applications to operate in municipalities in the United States on the United States-Mexico international border or within the commercial zones of such municipalities; part 385 safety fitness procedures; part 387 levels of financial responsibility; and part 390 general applicability of the FMCSRs. In each part, the provisions enacted by the URS 1 final rule that go into effect January 14, 2017, are being immediately suspended and replaced by temporary provisions that contain the same requirements in place on January 13, 2017. The only changes being made to the regulatory text are to replace internal cross references to CFR parts or sections that are either being suspended or have been removed with the corresponding temporary provision (found in the table below), and to include paragraph designations on previously undesignated text, in order to align with current guidelines for publication in the CFR. The following table lays out those provisions being suspended, and the corresponding temporary provision being added to replace the suspended regulations. Note that in some cases, there is not a corresponding suspended or temporary provision, as the URS 1 final rule both added new regulatory sections and removed sections without replacing them.
FMCSA has determined that this final rule, essentially delaying the effective date of the URS rules, is not a significant regulatory action within the meaning of E.O. 12866, as supplemented by E.O. 13563, or within the meaning of DOT regulatory policies and procedures. The Agency does not expect this action to have any new costs; this action suspending the provisions of the August 23, 2013 and reinstating the pre-existing registration provisions will delay the associated costs of the August 23, 2013, final rule. As discussed previously, this action is necessary because the URS 1 technological solution, required to implement the URS 1 final rule, is not ready. Not suspending the URS 1 final rule may result in additional costs, as allowing the URS 1 final rule to come into effect without having the required technological pieces (such as the URS online application and the integrated database required by statute) would require motor carriers, freight forwarders, brokers, and others to use a system that does not exist, with no alternative for seeking registration authorities. This could lead to a delay in processing registrations, which could then impact the applicants. Suspending the URS final rule and temporarily reinstating the pre-existing rules avoids these potential costs, without adding new costs over what was originally estimated in the August 2013 RIA. The August 2013 RIA can be found in the docket for this final rule.
Under the Regulatory Flexibility Act of 1980 (RFA) (5 U.S.C. 601-612), FMCSA is not required to complete a regulatory flexibility analysis. This is because this rule does not require publication of a general notice of proposed rulemaking. However, in compliance with the RFA, FMCSA has evaluated the effects of this final rule on small entities, and determined that delaying the effective date for the URS 1 final rule will not result in a significant economic impact on a substantial number of small entities. Accordingly, the Administrator of FMCSA hereby certifies that this rule will not have a significant economic impact on a substantial number of small entities.
This final rule will not impose an unfunded Federal mandate, as defined by the Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1532,
The Agency analyzed this final rule for the purpose of the National Environmental Policy Act of 1969 (NEPA) (42 U.S.C. 4321
FMCSA also has analyzed this rule under the Clean Air Act, as amended (CAA), section 176(c) (42 U.S.C. 7401
Under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3520), a Federal Agency must obtain approval from OMB for each collection of information it conducts, sponsors, or requires through regulations. The FMCSA analyzed the August 23, 2013, final rule and determined that its implementation would streamline the information collection burden on motor carriers and other regulated entities, relative to the baseline, or current paperwork collection processes. This included streamlining the FMCSA registration, insurance, and designation of process agent filing processes and implementing mandatory electronic online filing of these applications, as well as eliminating some outdated filing requirements. A full analysis of the impacted collections of information, both existing and new, can be found in that final rule,
This final rule will not result in a taking of private property or otherwise have taking implications under Executive Order 12630, Governmental Actions and Interference with Constitutionally Protected Property Rights.
This final rule meets applicable standards in sections 3(a) and 3(b)(2) of Executive Order 12988, Civil Justice Reform, to minimize litigation, eliminate ambiguity, and reduce burden.
Executive Order 13045, “Protection of Children from Environmental Health Risks and Safety Risks” (April 23, 1997, 62 FR 19885), requires that agencies issuing economically significant rules, which also concern an environmental health or safety risk that an Agency has reason to believe may disproportionately affect children, must include an evaluation of the environmental health and safety effects of the regulation on children. Section 5 of Executive Order 13045 directs an Agency to submit for a covered regulatory action an evaluation of its environmental health or safety effects on children. This final rule is not an economically significant rule and will not create an environmental risk to health or risk to safety that might disproportionately affect children.
This rule has been analyzed in accordance with the principles and criteria in Executive Order 13132, dated August 4, 1999 (64 FR 43255, August 10, 1999). The FMCSA consulted with State licensing agencies participating in its PRISM Program to discuss anticipated impacts of the May 2005 NPRM upon their operations. The Agency has taken into consideration their comments in its decision-making process for this rule. Thus, FMCSA has determined that this rule will not have significant Federalism implications or limit the policymaking discretion of the States.
The regulations implementing Executive Order 12372 regarding intergovernmental consultation on Federal programs and activities do not apply to this final rule.
FMCSA has analyzed this rule under Executive Order 13211, “Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use,” and has determined that this is not a significant energy action within the meaning of section 4(b) of the Executive Order. This final rule is not economically significant, and will not have a significant adverse effect on the supply, distribution, or use of energy.
The FMCSA conducted a privacy impact assessment (PIA) of the August 23, 2013, final rule as required by section 522(a)(5) of division H of the FY 2005 Omnibus Appropriations Act,Public Law 108-447, 118 Stat. 3268 (Dec. 8, 2004) [set out as a note to 5 U.S.C. 552a]. The assessment considered any impacts of the final rule on the privacy of information in an identifiable form and related matters. FMCSA determined that the August 23, 2013, final rule will impact the handling of personally identifiable information (PII). FMCSA also determined the risks and effects the rulemaking might have on collecting, storing, and sharing PII and examined and evaluated protections and alternative information handling processes in order to mitigate potential privacy risks. This final rule makes no changes to the information being collected, or to the manner that it is stored and shared. FMCSA believes that the PIA for the August 23, 2013, final rule adequately covers this action; that PIA remains available for review in the docket for this final rule.
Administrative practice and procedure, Brokers, Buses, Freight forwarders, Hazardous materials transportation, Highway safety, Insurance, Motor carriers, Motor vehicle safety, Moving of household goods, Penalties, Reporting and recordkeeping requirements, Surety bonds.
Administrative practice and procedure, Brokers, Buses, Freight forwarders, Motor carriers, Moving of household goods.
Brokers, Motor carriers, Freight forwarders, Process agents.
Administrative practice and procedure, Insurance, Motor carriers.
Administrative practice and procedure, Highway safety, Motor carriers, Motor vehicle safety, Reporting and recordkeeping requirements.
Buses, Freight, Freight forwarders, Hazardous materials transportation, Highway safety, Insurance, Intergovernmental relations, Motor carriers, Motor vehicle safety, Moving of household goods, Penalties, Reporting and recordkeeping requirements, Surety bonds.
Highway safety, Intermodal transportation, Motor carriers, Motor vehicle safety, Reporting and recordkeeping requirements.
In consideration of the foregoing, FMCSA amends 49 CFR chapter III as set forth below:
31 U.S.C. 9701; 49 U.S.C. 13908; and 49 CFR 1.87.
Certifications and copies of public records and documents on file with the Federal Motor Carrier Safety Administration will be furnished on the following basis, pursuant to the Freedom of Information Act regulations at 49 CFR part 7:
(a) Certificate of the Director, Office of Data Analysis and Information Systems, as to the authenticity of documents, $9.00;
(b) Service involved in checking records to be certified to determine authenticity, including clerical work, etc., incidental thereto, at the rate of $16.00 per hour;
(c) Copies of the public documents, at the rate of $.80 per letter size or legal size exposure. A minimum charge of $5.00 will be made for this service; and
(d) Search and copying services requiring ADP processing, as follows:
(1) A fee of $42.00 per hour for professional staff time will be charged when it is required to fulfill a request for ADP data.
(2) The fee for computer searches will be set at the current rate for computer service. Information on those charges can be obtained from the Office of Data Analysis and Information Systems (MC-RIS).
(3) Printing shall be charged at the rate of $.10 per page of computer generated output with a minimum charge of $.25. A charge of $30 per reel of magnetic tape will be made if the tape is to be permanently retained by the requestor.
(a)
(2)
(i) Each account will have a specific billing date within each month and a billing cycle. The billing date is the date that the bill is prepared and printed. The billing cycle is the period between the billing date in one month and the billing date in the next month. A bill for each account which has activity or an unpaid balance during the billing cycle will be sent on the billing date each month. Payment will be due 20 days from the billing date. Payments received before the next billing date are applied to the account. Interest will accrue in accordance with 4 CFR 102.13.
(ii) The Debt Collection Act of 1982, including disclosure to the consumer reporting agencies and the use of collection agencies, as set forth in 4 CFR 102.5 and 102.6 will be utilized to encourage payment where appropriate.
(iii) An account holder who files a petition in bankruptcy or who is the subject of a bankruptcy proceeding must provide the following information to the Office of Enforcement and Compliance, Insurance Division (MC-ECI):
(A) The filing date of the bankruptcy petition;
(B) The court in which the bankruptcy petition was filed;
(C) The type of bankruptcy proceeding;
(D) The name, address, and telephone number of its representative in the bankruptcy proceeding; and
(E) The name, address, and telephone number of the bankruptcy trustee, if one has been appointed.
(3) Fees will be payable to the Federal Motor Carrier Safety Administration by a check payable in United States currency drawn upon funds deposited in a United States or foreign bank or other financial institution, money order payable in United States' currency, or credit card (VISA or MASTERCARD).
(b) Any filing that is not accompanied by the appropriate filing fee is deficient except for filings that satisfy the deferred payment procedures in paragraph (a) of this section.
(c)
(d)
(2) Separate fees will be assessed for the filing of temporary operating authority applications as provided in paragraph (f)(6) of this section, regardless of whether such applications are related to an application for corresponding permanent operating authority.
(3) The Federal Motor Carrier Safety Administration may reject concurrently filed applications, petitions, or other documents asserted to be related and refund the filing fee if, in its judgment, they embrace two or more severable matters which should be the subject of separate proceedings.
(e)
(1) Filing fees are waived for an application or other proceeding which is filed by a Federal government agency, or a State or local government entity. For purposes of this section the phrases “Federal government agency” or “government entity” do not include a quasi-governmental corporation or
(2) In extraordinary situations the Federal Motor Carrier Safety Administration will accept requests for waivers or fee reductions in accordance with the following procedure:
(i)
(ii)
(iii)
(f)
(g)
(i) All work will be suspended on the filing or proceeding, until the check is made good;
(ii) A returned check charge of $6.00 and any bank charges incurred by the FMCSA as a result of the dishonored check must be submitted with the filing fee which is outstanding; and
(iii) If payment is not made within the time specified by the FMCSA, the proceeding will be dismissed or the filing may be rejected.
(2) If a person repeatedly submits dishonored checks to the FMCSA for filing fees, the FMCSA may notify the person that all future filing fees must be submitted in the form of a certified or cashier's check, money order, or credit card.
(a)
(b)
(c)
(d)
(1) Direct labor costs shall be updated by multiplying base level direct labor costs by percentage changes in average wages and salaries of FMCSA employees. Base level direct labor costs are direct labor costs determined by the cost study in Regulations Governing Fees For Service, 1 I.C.C. 2d 60 (1984), or subsequent cost studies. The base period for measuring changes shall be April 1984 or the year of the last cost study.
(2) Operations overhead shall be developed each year on the basis of current relationships existing on a weighted basis, for indirect labor applicable to the first supervisory work centers directly associated with user fee activity. Actual updating of operations overhead will be accomplished by applying the current percentage factor to updated direct labor, including current governmental overhead costs.
(3)(i) Office general and administrative costs shall be developed
(ii) FMCSA general and administrative costs shall be developed each year on the basis of current level costs;
(4) Publication costs shall be adjusted on the basis of known changes in the costs applicable to publication of material in the
(e)
(1) Fees between $1 and $30 will be rounded to the nearest $1;
(2) Fees between $30 and $100 will be rounded to the nearest $10;
(3) Fees between $100 and $999 will be rounded to the nearest $50; and
(4) Fees above $1,000 will be rounded to the nearest $100.
5 U.S.C. 553 and 559; 49 U.S.C. 13101, 13301, 13901-13906, 13908, 14708, 31133, 31138, and 31144; 49 CFR 1.87.
These rules govern the handling of applications for operating authority of the following type:
(a) Applications for certificates and permits to operate as a motor common or contract carrier of property or passengers.
(b) Applications for permits to operate as a freight forwarder.
(c) [Reserved]
(d) Applications for licenses to operate as a broker of motor vehicle transportation.
(e) Applications for certificates under 49 U.S.C. 13902(b)(3) to operate as a motor carrier of passengers in intrastate commerce over regular routes if such intrastate transportation is to be provided on a route over which the carrier provides interstate transportation of passengers.
(f) [Reserved]
(g) Applications for temporary motor carrier authority.
(h) Applications for Mexico-domiciled motor carriers to operate in foreign commerce as common, contract or private motor carriers of property (including exempt items) between Mexico and all points in the United States. Under NAFTA Annex I, pageI-U-20, a Mexico-domiciled motor carrier may not provide point-to-point transportation services, including express delivery services, within the United States for goods other than international cargo.
(i) Applications for non-North America-domiciled motor carriers to operate in foreign commerce as for-hire motor carriers of property and passengers within the United States.
(j) The rules in this part do not apply to “pipeline welding trucks” as defined in 49 CFR 390.38(b).
The FMCSA will handle licensing application proceedings using the modified procedure, if possible. The applicant and protestants send statements made under oath (verified statements) to each other and to the FMCSA. There are no personal appearances or formal hearings.
(a)(1) Each applicant must file the appropriate form in the OP-1 series. Form OP-1 must be filed when requesting authority to operate as a motor property carrier, a broker of general freight, or a broker of household goods; Form OP-1(P) must be filed when requesting authority to operate as a motor passenger carrier; Form OP-1(FF) must be filed when requesting authority to operate as a freight forwarder; Form OP-1(MX) must be filed by a Mexico-domiciled motor property, including household goods, carrier, or a motor passenger carrier requesting authority to operate within the United States; and effective December 16, 2009.
(2) Form OP-1(NNA) must be filed by a non-North America-domiciled motor property, including household goods, carrier or a motor passenger carrier requesting authority to operate within the United States. A separate filing fee in the amount set forth at 49 CFR 360.3T(f)(1) is required for each type of authority sought.
(b) Obtain forms at a FMCSA Division Office in each State or at one of the FMCSA Service Centers. Addresses and phone numbers for the Division Offices and Service Centers can be found at:
(a) Notwithstanding § 365.105T, new applicants as defined in paragraph (b) of this section must apply for a USDOT number and if applicable, operating authority by electronically filing Form MCSA-1, the URS online application, to request authority pursuant to 49 U.S.C. 13902, 13903, or 13904 to operate as a:
(1) Motor carrier of property (not household goods), property (household goods) or passengers;
(2) Broker of general commodities or household goods; or
(3) Freight forwarder of general commodities or household goods.
(b) For purposes of this section, a “new applicant” is an entity applying for a USDOT number and if applicable, operating authority who does not at the time of application have an active registration or USDOT, Motor Carrier (MC), Mexico owned or controlled (MX) or Freight Forwarder (FF) number, and who has never had an active registration or USDOT, MC, MX, or FF number.
(c) Form MCSA-1 is the URS online application, and both the application and its instructions are available from the FMCSA Web site at
(a)
(1) Motor common and contract carrier of property (except household goods), Mexican motor property carriers that perform private carriage and transport exempt items, and motor contract carrier of passengers transportation.
(2) Motor carrier brokerage of general commodities (except household goods).
(3) Certain types of motor passenger applications as described in Form OP-1 (P).
(b) Motor passenger “public interest” applications as described in Form OP-1 (P).
(c) Intrastate motor passenger applications under 49 U.S.C. 13902(b)(3) as described in Form OP-1, Schedule B.
(d)
(1) The applicant is fit, willing, and able to provide the involved transportation and to comply with all applicable statutory and regulatory provisions; and
(2) The service proposed will serve a useful public purpose, responsive to a public demand or need.
(e)
(1) The applicant is fit, willing, and able to provide the involved transportation and to comply with all applicable statutory and regulatory provisions; and
(2) The transportation to be provided will be consistent with the public interest and the national transportation policy of 49 U.S.C. 13101.
(f)
(g) In view of the expedited time frames established in this part for processing requests for permanent authority, applications for TA will be entertained only in exceptional circumstances (
(a) FMCSA staff will review the application for correctness, completeness, and adequacy of the evidence (the
(1) Minor errors will be corrected without notification to the applicant.
(2) Materially incomplete applications will be rejected. Applications that are in substantial compliance with these rules may be accepted.
(3) All motor carrier applications will be reviewed for consistency with the FMCSA's operational safety fitness policy. Applicants with “Unsatisfactory” safety fitness ratings from DOT will have their applications rejected.
(4) FMCSA staff will review completed applications that conform with the FMCSA's safety fitness policy and that are accompanied by evidence of adequate financial responsibility.
(5) Financial responsibility is indicated by filing within 20 days from the date an application notice is published in the
(i) Form BMC-91 or 91X or BMC 82 surety bond—Bodily injury and property damage (motor property and passenger carriers; household goods freight forwarders that provide pickup or delivery service directly or by using a local delivery service under their control).
(ii) Form BMC-84—Surety bond or Form BMC-85—trust fund agreement (property brokers of general commodities and household goods).
(iii) Form BMC 34 or BMC 83 surety bond—Cargo liability (household goods motor carriers and household goods freight forwarders).
(6) Applicants also must submit Form BOC-3—designation of legal process agents—within 20 days from the date an application notice is published in the
(7) Applicants seeking to conduct operations for which tariffs are required may not commence such operations until tariffs are in effect.
(8) All applications must be completed in English.
(b) A summary of the application will be published as a preliminary grant of authority in the
(a) An applicant has the right to appeal rejection of the application. The appeal must be filed at the FMCSA within 10 days of the date of the letter of rejection.
(b) If the appeal is successful and the filing is found to be proper, the application shall be deemed to have been properly filed as of the decision date of the appeal.
If the application is opposed, opposing parties are required to send a copy of their protest to the applicant.
A person wishing to oppose a request for permanent authority files a protest. A person filing a valid protest becomes a
A protest shall be filed (received at the FMCSA) within 10 days after notice of the application appears in the
Generally, all application proceedings are governed by the FMCSA's Rules of Practice at part 386 of this chapter except as designated below.
These rules define the procedures that enable motor passenger and property carriers, property brokers, and household goods freight forwarders to obtain approval from the FMCSA to merge, transfer, or lease their operating rights in financial transactions not subject to 49 U.S.C. 11343. Transactions covered by these rules are governed by 49 U.S.C. 10321 and 10926. The filing fee is set forth at 49 CFR 360.3T(f)(8).
For the purposes of this part, the following definitions apply:
(a)
(b)
(1) Certificates and permits issued to motor carriers;
(2) Permits issued to freight forwarders;
(3) Licenses issued to property brokers; and
(4) Certificates of Registration issued to motor carriers. The term also includes authority held by virtue of the gateway elimination regulations published in the
(c)
(d)
(e)
(f)
(g)
(h)
(a)
(2) At any time after the expiration of the 10-day waiting period, applicants may consummate the transaction, subject to the subsequent approval of the application by the FMCSA, as described below. The transferee may commence operations under the rights acquired from the transferor upon its compliance with the FMCSA's regulations governing insurance, and process agents. See 49 CFR parts 387, subpart C, and 366, respectively. In the alternative, applicants may wait until the FMCSA has issued a decision on their application before transferring the operating rights. If the transferee wants the transferor's operating authority to be reissued in its name, it should furnish the FMCSA with a statement executed by both transferor and transferee indicating that the transaction has been consummated. Authority will not be reissued until after the FMCSA has approved the transaction.
(b)
(i) Full name, address, and signatures of the transferee and transferor.
(ii) A copy of the transferor's operating authority involved in the transfer proceeding.
(iii) A short summary of the essential terms of the transaction.
(iv) If relevant, the status of proceedings for the transfer of State certificate(s) corresponding to the Certificates of Registration being transferred.
(v) A statement as to whether the transfer will or will not significantly affect the quality of the human environment.
(vi) Certification by transferor and transferee of their current respective safety ratings by the United States Department of Transportation (
(vii) Certification by the transferee that it has sufficient insurance coverage under 49 U.S.C. 13906 for the service it intends to provide.
(viii) Information to demonstrate that the proposed transaction is consistent with the national transportation policy and satisfies the criteria for approval set forth at § 365.409T. (Such information may be appended to the application form and, if provided, would be embraced by the oath and verification contained on that form.)
(ix) If motor carrier operating rights are being transferred, certification by the transferee that it is not domiciled in Mexico nor owned or controlled by persons of that country.
(2) Category 2 applicants must also submit the following additional information:
(i) Name(s) of the carrier(s), if any, with which the transferee is affiliated.
(ii) Aggregate revenues of the transferor, transferee, and their carrier affiliates from interstate transportation sources for a 1-year period ending not earlier than 6 months before the date of the agreement of the parties concerning the transaction. If revenues exceed $2 million, the transfer may be subject to 49 U.S.C. 14303 rather than these rules.
The FMCSA will give notice of approved transfer applications through publication in the
A transfer will be approved under this section if:
(a) The transaction is not subject to 49 U.S.C. 14303; and
(b) The transaction is consistent with the public interest; however,
(c) If the transferor or transferee has an “Unsatisfactory” safety fitness rating from DOT, the transfer may be denied. If an application is denied, the FMCSA will set forth the basis for its action in a decision or letter notice. If parties with “Unsatisfactory” safety fitness ratings consummate a transaction pursuant to the 10-day rule at § 365.405T prior to the notification of FMCSA action, they do so at their own risk and subject to any conditions we may impose subsequently. Transactions that have been consummated but later are denied by the FMCSA are null and void and must be rescinded. Similarly, if applications contain false or misleading information, they are void
(a) Protests must be filed within 20 days after the date of publication of an
(b) Protests and petitions for reconsideration must be filed with the Federal Motor Carrier Safety Administration, Office of Registration and Safety Information (MC-RS), 1200 New Jersey Ave. SE., Washington, DC 20590-0001, and be served on appropriate parties.
(a)
(1) A change in the form of a business, such as the incorporation of a partnership or sole proprietorship;
(2) A change in the legal name of a corporation or partnership or change in the trade name or assumed name of any entity;
(3) A transfer of operating rights from a deceased or incapacitated spouse to the other spouse;
(4) A reincorporation and merger for the purpose of effecting a name change;
(5) An amalgamation or consolidation of a carrier and a noncarrier into a new carrier having a different name from either of the predecessor entities; and
(6) A change in the State of incorporation accomplished by dissolving the corporation in one State and reincorporating in another State.
(b)
(1) Scanned and submitted via the web form at
(2) Faxed to (202-366-3477); or
(3) Mailed to the Federal Motor Carrier Safety Administration, Office of Registration and Safety Information (MC-RS), 1200 New Jersey Ave. SE., Washington, DC 20590-0001. The envelope should be marked “NAME CHANGE”.
(c) The registrant must provide:
(1) The docket number(s) and name of the carrier, freight forwarder, or property broker requesting the change;
(2) A copy of the articles of incorporation and the State certificate reflecting the incorporation;
(3) The name(s) of the owner(s) of the stock and the distribution of the shares;
(4) The names of the officers and directors of the corporation; and
(5) A statement that there is no change in the ownership, management, or control of the business. When this procedure is being used to transfer operating rights from a deceased or incapacitated spouse to the other spouse, documentation that the other spouse has the legal right to effect such change must be included with the request. The fee for filing a name change request is in § 360.3T(f) of this chapter.
(a) The FMCSA will review and act on each application submitted under this subpart in accordance with the procedures set out in this part.
(b) The FMCSA will validate the accuracy of information and certifications provided in the application by checking data maintained in databases of the governments of Mexico and the United States.
(c)
(d) If a carrier successfully completes the pre-authorization safety audit and the FMCSA approves its application submitted under this subpart, FMCSA will publish a summary of the application as a preliminary grant of authority in the
(e) If the FMCSA grants provisional operating authority to the applicant, it will assign a distinctive USDOT Number that identifies the motor carrier as authorized to operate beyond the municipalities in the United States on the U.S.-Mexico international border and beyond the commercial zones of such municipalities. In order to operate in the United States, a Mexico-domiciled motor carrier with provisional operating authority must:
(1) Have its surety or insurance provider file proof of financial responsibility in the form of certificates of insurance, surety bonds, and endorsements, as required by § 387.301T of this subchapter;
(2) File a hard copy of, or have its process agent(s) electronically submit, Form BOC-3—Designation of Agents-Motor Carriers, Brokers and Freight Forwarders, as required by part 366 of this subchapter; and
(3) Comply with all provisions of the safety monitoring system in subpart B of part 385 of this subchapter, including successfully passing CVSA Level I inspections at least every 90 days and having decals affixed to each commercial motor vehicle operated in the United States as required by § 385.103(c) of this subchapter.
(f) The FMCSA may grant permanent operating authority to a Mexico-domiciled carrier no earlier than 18 months after the date that provisional operating authority is granted and only after successful completion to the satisfaction of the FMCSA of the safety monitoring system for Mexico-domiciled carriers set out in subpart B of part 385 of this subchapter. Successful completion includes obtaining a satisfactory safety rating as the result of a compliance review.
(a) A motor carrier subject to this subpart must notify the FMCSA of any changes or corrections to the information in parts I, IA or II submitted on the Form OP-1(MX) or the Form BOC-3—Designation of Agents—Motor Carriers, Brokers and Freight Forwarders during the application process or after having been granted provisional operating authority. The carrier must notify the FMCSA in writing within 45 days of the change or correction.
(b) If a carrier fails to comply with paragraph (a) of this section, the FMCSA may suspend or revoke its operating authority until it meets those requirements.
49 U.S.C. 502, 503, 13303, 13304 and 13908; and 49 CFR 1.87.
These rules, relating to the filing of designations of persons upon whom court process may be served, govern motor carriers and brokers and, as of the moment of succession, their fiduciaries (as defined at 49 CFR 387.319(a)).
Designations shall be made on Form BOC-3,
All persons (as defined at 49 U.S.C. 13102(18)) designated as process agents must reside in or maintain an office in the State for which they are designated. If a State official is designated, evidence of his or her willingness to accept service of process must be furnished.
(a)
(b)
Where an association or corporation has filed with the FMCSA a list of process agents for each State, motor carriers may make the required designations by using the following statement:
Those persons named in the list of process agents on file with the Federal Motor Carrier Safety Administration by ____ (Name of association or corporation) and any subsequently filed revisions thereof, for the States in which this carrier is or may be authorized to operate, including States traversed during such operations, except those States for which individual designations are named.
A designation may be canceled or changed only by a new designation except that, where a carrier or broker ceases to be subject to § 366.4T in whole or in part for 1 year, designation is no longer required and may be canceled without making another designation.
49 U.S.C. 13301, 13902 and 13908; Pub. L. 106-159, 113 Stat. 1748; and 49 CFR 1.87.
(a) Notwithstanding any other provision of this part, new applicants as defined in paragraph (b) of this section must apply for a USDOT number and operating authority by electronically filing Form MCSA-1, the URS online application (available at
(b) For purposes of this section, a “new applicant” is an citizen of Mexico or a motor carrier owned or controlled by a citizen of Mexico, applying for a USDOT number and operating authority who does not at the time of application have an active registration or USDOT, Motor Carrier (MC), Mexico owned or controlled (MX) or Freight Forwarder (FF) number, and who has never had an active registration or USDOT, MC, MX, or FF number.
(c) Form MCSA-1, is the URS online application, and both the application and its instructions are available from the FMCSA Web site at
(a) If you wish to obtain a certificate of registration under this part, you must submit an application that includes the following:
(1) Form OP-2—Application for Mexican Certificate of Registration for Foreign Motor Carriers and Foreign Motor Private Carriers Under 49 U.S.C. 13902;
(2) Form MCS-150—Motor Carrier Identification Report; and
(3) A notification of the means used to designate process agents, either by submission in the application package of Form BOC-3—Designation of Agents—Motor Carriers, Brokers and Freight Forwarders or a letter stating that the applicant will use a process agent service that will submit the Form BOC-3 electronically.
(b) The FMCSA will only process your application for a Certificate of Registration if it meets the following conditions:
(1) The application must be completed in English;
(2) The information supplied must be accurate and complete in accordance with the instructions to the Form OP-2, Form MCS-150 and Form BOC-3;
(3) The application must include all the required supporting documents and applicable certifications set forth in the instructions to the Form OP-2, Form MCS-150 and Form BOC-3;
(4) The application must include the filing fee payable to the FMCSA in the amount set forth in 49 CFR 360.3T(f)(1); and
(5) The application must be signed by the applicant.
(c) If you fail to furnish the complete application as described under paragraph (b) of this section your application may be rejected.
(d) If you submit false information under this section, you will be subject to applicable Federal penalties.
(e) You must submit the application to the address provided in the instructions to the Form OP-2.
(f) You may obtain the application described in paragraph (a) of this section from any FMCSA Division Office or download it from the FMCSA Web site at:
(a) You must notify the FMCSA of any changes or corrections to the information in Parts I, IA or II submitted on the Form OP-2 or the Form BOC-3—Designation of Agents—Motor Carriers, Brokers and Freight Forwarders during
(b) If you fail to comply with paragraph (a) of this section, the FMCSA may suspend or revoke the Certificate of Registration until you meet those requirements.
An applicant has the right to appeal denial of the application. The appeal must be in writing and specify in detail why the agency's decision to deny the application was wrong. The appeal must be filed with the Director, Office of Data Analysis and Information Systems within 20 days of the date of the letter denying the application. The decision of the Director will be the final agency order.
49 U.S.C. 113, 504, 521(b), 5105(e), 5109, 5113, 13901-13905, 13908, 31136, 31144, 31148, 31151, and 31502; Sec. 350 of Pub. L. 107-87; and 49 CFR 1.87.
(a) Before a motor carrier of property or passengers begins interstate operations, it must register with the FMCSA and receive a USDOT number. In addition, for-hire motor carriers must obtain operating authority from FMCSA following the registration procedures described in 49 CFR part 365, unless providing transportation exempt from 49 CFR part 365 registration requirements.
(b) This subpart applies to motor carriers domiciled in the United States and Canada.
(c) A Mexico-domiciled motor carrier of property or passengers must register with the FMCSA by following the registration procedures described in 49 CFR part 365 or 368, as appropriate. The regulations in this subpart do not apply to Mexico-domiciled carriers.
A motor carrier may contact the FMCSA by internet (
(a) The requester for new entrant registration will be directed to the FMCSA Internet Web site (
(b) The application package will contain the following:
(1) Educational and technical assistance material regarding the requirements of the FMCSRs and HMRs, if applicable.
(2) The Form MCS-150, The Motor Carrier Identification Report.
(3) Application forms to obtain operating authority under 49 CFR part 365, as appropriate.
(c) Upon completion of the application forms, the new entrant will be issued a USDOT number.
(d) For-hire motor carriers, unless providing transportation exempt from 49 CFR part 365 registration requirements, must also comply with the procedures established in 49 CFR part 365 to obtain operating authority before operating in interstate commerce.
(a) A new entrant whose USDOT new entrant registration has been revoked, and whose operations have been placed out of service by FMCSA, may reapply for new entrant registration no sooner than 30 days after the date of revocation.
(b) If the USDOT new entrant registration was revoked because of a failed safety audit, the new entrant must do all of the following:
(1) Submit an updated MCS-150.
(2) Submit evidence that it has corrected the deficiencies that resulted in revocation of its registration and will otherwise ensure that it will have basic safety management controls in effect.
(3) Begin the 18-month new entrant monitoring cycle again as of the date the re-filed application is approved.
(c) If the USDOT new entrant registration was revoked because FMCSA found that the new entrant had failed to submit to a safety audit, it must do all of the following:
(1) Submit an updated MCS-150.
(2) Begin the 18-month new entrant monitoring cycle again as of the date the re-filed application is approved.
(3) Submit to a safety audit.
(d) If the new entrant is a for-hire carrier subject to the registration provisions under 49 U.S.C. 13901 and also has had its operating authority revoked, it must re-apply for operating authority as set forth in part 365 of this chapter.
(a)
(2) The Form MCS-150B will also satisfy the requirements for obtaining and renewing a USDOT Number; there is no need to complete Form MCS-150, Motor Carrier Identification Report.
(b)
(c)
(d)
(a)
(b) FMCSA will not issue a temporary safety permit to a motor carrier that:
(1) Does not certify that it has a satisfactory security program as required in § 385.407(b);
(2) Has a crash rate in the top 30 percent of the national average as indicated in the FMCSA's Motor Carrier Management Information System (MCMIS); or
(3) Has a driver, vehicle, hazardous materials, or total out-of-service rate in the top 30 percent of the national average as indicated in the MCMIS.
(c) A temporary safety permit shall be valid for 180 days after the date of issuance or until the motor carrier is assigned a new safety rating, whichever occurs first.
(1) A motor carrier that receives a Satisfactory safety rating will be issued a safety permit (see § 385.421T).
(2) A motor carrier that receives a less than Satisfactory safety rating is ineligible for a safety permit and will be subject to revocation of its temporary safety permit.
(d) If a motor carrier has not received a safety rating within the 180-day time period, FMCSA will extend the effective date of the temporary safety permit for an additional 60 days, provided the motor carrier demonstrates that it is continuing to operate in full compliance with the FMCSRs and HMRs.
Unless suspended or revoked, a safety permit (other than a temporary safety permit) is effective for two years, except that:
(a) A safety permit will be subject to revocation if a motor carrier fails to submit a renewal application (Form MCS-150B) in accordance with the schedule set forth for filing Form MCS-150 in § 390.19T(a) of this chapter; and
(b) An existing safety permit will remain in effect pending FMCSA's processing of an application for renewal if a motor carrier submits the required application (Form MS-150B) in accordance with the schedule set forth in § 390.19T(a)(2) and (3) of this chapter.
(a)
(1) A motor carrier fails to submit a renewal application (Form MCS-150B) in accordance with the schedule set forth in § 390.19T(a)(2) and (3) of this chapter;
(2) A motor carrier provides any false or misleading information on its application (Form MCS-150B) or as part of updated information it is providing on Form MCS-150B (see § 385.405T(d)).
(3) A motor carrier is issued a final safety rating that is less than Satisfactory;
(4) A motor carrier fails to maintain a satisfactory security plan as set forth in § 385.407(b);
(5) A motor carrier fails to comply with applicable requirements in the FMCSRs, the HMRs, or compatible State requirements governing the transportation of hazardous materials, in a manner showing that the motor carrier is not fit to transport the hazardous materials listed in § 385.403;
(6) A motor carrier fails to comply with an out-of-service order;
(7) A motor carrier fails to comply with any other order issued under the FMCSRs, the HMRs, or compatible State requirements governing the transportation of hazardous materials, in a manner showing that the motor carrier is not fit to transport the hazardous materials listed in § 385.403;
(8) A motor carrier fails to maintain the minimum financial responsibility required by § 387.9 of this chapter or an applicable State requirement;
(9) A motor carrier fails to maintain current hazardous materials registration with the Pipeline and Hazardous Materials Safety Administration; or
(10) A motor carrier loses its operating rights or has its registration suspended in accordance with § 386.83 or § 386.84 of this chapter for failure to pay a civil penalty or abide by a payment plan.
(b)
(c)
(1) Immediately after FMCSA determines that an imminent hazard exists, after FMCSA issues a final safety rating that is less than Satisfactory, or after a motor carrier loses its operating rights or has its registration suspended for failure to pay a civil penalty or abide by a payment plan;
(2) Thirty (30) days after service of a written notification that FMCSA proposes to suspend or revoke a safety permit, if the motor carrier does not submit a written request for administrative review within that time period; or
(3) As specified in § 385.423(c), when the motor carrier submits a written request for administrative review of FMCSA's proposal to suspend or revoke a safety permit.
(4) A motor carrier whose safety permit has been revoked will not be issued a replacement safety permit or temporary safety permit for 365 days from the time of revocation.
(a) Each applicant applying under this subpart must submit an application that consists of:
(1) Form OP-1(NNA)—Application for U.S. Department of Transportation (USDOT) Registration by Non-North America-Domiciled Motor Carriers;
(2) Form MCS-150—Motor Carrier Identification Report; and
(3) A notification of the means used to designate process agents, either by submission in the application package of Form BOC-3—Designation of Agents—Motor Carriers, Brokers and Freight Forwarders or a letter stating that the applicant will use a process agent service that will submit the Form BOC-3 electronically.
(b) FMCSA will only process an application if it meets the following conditions:
(1) The application must be completed in English;
(2) The information supplied must be accurate, complete, and include all required supporting documents and applicable certifications in accordance with the instructions to Form OP-1(NNA), Form MCS-150 and Form BOC-3;
(3) The application must include the filing fee payable to the FMCSA in the amount set forth at 49 CFR 360.3T(f)(1); and
(4) The application must be signed by the applicant.
(c) An applicant must submit the application to the address provided in Form OP-1(NNA).
(d) An applicant may obtain the application forms from any FMCSA Division Office or download them from the FMCSA Web site at:
(a) FMCSA will review and act on each application submitted under this subpart in accordance with the procedures set out in this part.
(b) FMCSA will validate the accuracy of information and certifications provided in the application by checking, to the extent available, data maintained in databases of the governments of the country where the carrier's principal place of business is located and the United States.
(c) Pre-authorization safety audit. Every non-North America-domiciled motor carrier that applies under this part must satisfactorily complete an FMCSA-administered safety audit before FMCSA will grant new entrant registration to operate in the United States. The safety audit is a review by FMCSA of the carrier's written procedures and records to validate the accuracy of information and certifications provided in the application and determine whether the carrier has established or exercises the basic safety management controls necessary to ensure safe operations. FMCSA will evaluate the results of the safety audit using the criteria in the appendix to this subpart.
(d) An application of a non-North America-domiciled motor carrier requesting for-hire operating authority under part 365 of this subchapter may be protested under § 365.109T(b). Such a carrier will be granted new entrant registration after successful completion of the pre-authorization safety audit and the expiration of the protest period, provided the application is not protested. If a protest to the application is filed with FMCSA, new entrant registration will be granted only if FMCSA denies or rejects the protest.
(e) If FMCSA grants new entrant registration to the applicant, it will assign a distinctive USDOT Number that identifies the motor carrier as authorized to operate in the United States. In order to initiate operations in the United States, a non-North America-domiciled motor carrier with new entrant registration must:
(1) Have its surety or insurance provider file proof of financial responsibility in the form of certificates of insurance, surety bonds, and endorsements, as required by §§ 387.7(e)(2), 387.31(e)(2), and 387.301T of this subchapter, as applicable; and
(2) File a hard copy of, or have its process agent(s) electronically submit, Form BOC-3—Designation of Agents—Motor Carriers, Brokers and Freight Forwarders, as required by part 366 of this subchapter.
(f) A non-North America-domiciled motor carrier must comply with all provisions of the safety monitoring system in subpart I of this part, including successfully passing North American Standard commercial motor vehicle inspections at least every 90 days and having safety decals affixed to each commercial motor vehicle operated in the United States as required by § 385.703(c).
(g) FMCSA may not re-designate a non-North America-domiciled carrier's registration from new entrant to permanent prior to 18 months after the date its USDOT Number is issued and subject to successful completion of the safety monitoring system for non-North America-domiciled carriers set out in subpart I of this part. Successful completion includes obtaining a Satisfactory safety rating as the result of a compliance review.
(a)(1) A motor carrier subject to this subpart must notify FMCSA of any changes or corrections to the information the Form BOC-3—Designation of Agents—Motor Carriers, Brokers and Freight Forwarders that occur during the application process or after having been granted new entrant registration.
(2) A motor carrier subject to this subpart must notify FMCSA of any changes or corrections to the information in Section I, IA or II of Form OP-1(NNA)—Application for U.S. Department of Transportation (USDOT) Registration by Non-North America-Domiciled Motor Carriers that occurs during the application process or after having been granted new entrant registration.
(3) A motor carrier must notify FMCSA in writing within 45 days of the change or correction to information under paragraph (a)(1) or (2) of this section.
(b) If a motor carrier fails to comply with paragraph (a) of this section, FMCSA may suspend or revoke its new entrant registration until it meets those requirements.
(a) A non-North America-domiciled motor carrier whose provisional new entrant registration has been revoked may reapply for new entrant registration no sooner than 30 days after the date of revocation.
(b) If the provisional new entrant registration was revoked because the new entrant failed to receive a Satisfactory rating after undergoing a compliance review, the new entrant must do all of the following:
(1) Submit an updated MCS-150.
(2) Submit evidence that it has corrected the deficiencies that resulted in revocation of its registration and will otherwise ensure that it will have basic safety management controls in effect.
(3) Successfully complete a pre-authorization safety audit in accordance with § 385.607T(c).
(4) Begin the 18-month new entrant monitoring cycle again as of the date the re-filed application is approved.
(c) If the provisional new entrant registration was revoked because FMCSA found that the new entrant had failed to submit to a compliance review, it must do all of the following:
(1) Submit an updated MCS-150.
(2) Successfully complete a pre-authorization safety audit in accordance with § 385.607T(c).
(3) Begin the 18-month new entrant monitoring cycle again as of the date the re-filed application is approved.
(4) Submit to a compliance review upon request.
(d) If the new entrant is a for-hire carrier subject to the registration provisions under 49 U.S.C. 13901 and also has had its operating authority revoked, it must re-apply for operating authority as set forth in part 365 of this subchapter.
49 U.S.C. 13101, 13301, 13906, 13908, 14701, 31138, and 31139; and 49 CFR 1.87.
The minimum levels of financial responsibility referred to in § 387.31 are hereby prescribed as follows:
For-hire motor carriers of passengers operating in interstate or foreign commerce.
(a)
(2) Motor Carriers of property which are subject to the conditions set forth in paragraph (a)(1) of this section and transport the commodities described in § 387.303T(b)(2), are required to obtain security in the minimum limits prescribed in § 387.303T(b)(2).
(b)
(c)
(a)
(2)
(b)(1) Motor carriers subject to § 387.301T(a)(1) are required to have security for the required minimum limits as follows:
(i)
(ii)
(2) Motor carriers subject to § 387.301T(a)(2) are required to have security for the required minimum limits as follows:
(3) Motor carriers subject to the minimum limits governed by this section, which are also subject to Department of Transportation limits requirements, are at no time required to have security for more than the required minimum limits established by the Secretary of Transportation in the applicable provisions of this part.
(4)
(i) The certificate of registration;
(ii) The required insurance endorsement (Form MCS-90); and
(iii) An insurance identification card, binder, or other document issued by an authorized insurer which specifies both the effective date and the expiration date of the insurance coverage.
Notwithstanding the provisions of § 387.301T(a)(1), the filing of evidence of insurance is not required as a condition to the issuance of a certificate of registration. Further, the reference to continuous coverage at § 387.313T(a)(6) and the reference to cancellation notice at § 387.313T(d) are not applicable to these carriers.
(c)
(1) For loss of or damage to household goods carried on any one motor vehicle—$5,000; and
(2) For loss of or damage to or aggregate of losses or damages of or to household goods occurring at any one time and place—$10,000.
(a)
(2)
See Note for Rule 387.311. Also, it should be noted that DOT is considering prescribing adaptations of the
(ii) For aggregation of insurance for all other carriers to cover security limits under § 387.303T(b)(1) or (2), a separate Department of Transportation prescribed form endorsement and
(iii) For aggregation of insurance for foreign motor private carriers of nonhazardous commodities to cover security limits under § 387.303T(b)(4), a separate
(3)
(i)
(ii)
(iii)
(4)
(5)
(6)
(i) When filed expressly to fill prior gaps or lapses in coverage or to cover grants of emergency temporary authority of unusually short duration and the filing clearly so indicates; or
(ii) In special or unusual circumstances, when special permission is obtained for filing certificates of insurance or surety bonds on terms meeting other particular needs of the situation.
(b)
(c)
(d)
(e)
(f)
(a) Insurers may, at their option and in accordance with the requirements and procedures set forth in paragraphs (a) through (d) of this section, file forms BMC 34, BMC 35, BMC 36, BMC 82, BMC 83, BMC 84, BMC 85, BMC 91, and BMC 91X electronically, in lieu of using the prescribed printed forms.
(b) Each insurer must obtain authorization to file electronically by registering with the FMCSA. An individual account number and password for computer access will be issued to each registered insurer.
(c) Filings may be transmitted online via the Internet at:
(d) All registered insurers agree to furnish upon request to the FMCSA a duplicate original of any policy (or policies) and all endorsements, surety bond, trust fund agreement, or other filing.
(a)
(b)
(c)
(a)
(b)
(c)
(d)
(e)
(f)
Insurers may, at their option and in accordance with the requirements and procedures set forth at § 387.323T, file certificates of insurance, surety bonds, and other securities and agreements electronically.
49 U.S.C. 508, 13301, 13902, 13908, 31132, 31133, 31136, 31151, 31502, 31504; sec. 114, Pub. L. 103-311, 108 Stat. 1673, 1677; sec. 217, Pub. L. 106-159, 113 Stat. 1748, 1767; sec. 4136, Pub. L. 109-59, 119 Stat. 1144, 1745; and 49 CFR 1.87.
(a)(1) The rules in this subchapter are applicable to all employers, employees, and commercial motor vehicles that transport property or passengers in interstate commerce.
(2) The rules in 49 CFR 386.12(e) and 390.6 prohibiting the coercion of drivers of commercial motor vehicles operating in interstate commerce:
(i) To violate certain safety regulations are applicable to all motor carriers, shippers, receivers, and transportation intermediaries; and
(ii) To violate certain commercial regulations are applicable to all operators of commercial motor vehicles.
(b) The rules in part 383 of this chapter, Commercial Driver's License Standards; Requirements and Penalties, are applicable to every person who operates a commercial motor vehicle, as defined in § 383.5 of this subchapter, in interstate or intrastate commerce and to all employers of such persons.
(c) The rules in part 387 of this chapter, Minimum Levels of Financial Responsibility for Motor Carriers, are applicable to motor carriers as provided in § 387.3 or § 387.27 of this subchapter.
(d)
(e)
(2) Every driver and employee shall be instructed regarding, and shall comply with, all applicable regulations contained in this subchapter.
(3) All motor vehicle equipment and accessories required by this subchapter shall be maintained in compliance with all applicable performance and design criteria set forth in this subchapter.
(f)
(1) All school bus operations as defined in § 390.5T, except for the provisions of §§ 391.15(e) and (f), 392.80, and 392.82 of this chapter.
(2) Transportation performed by the Federal government, a State, or any political subdivision of a State, or an agency established under a compact between States that has been approved by the Congress of the United States;
(3) The occasional transportation of personal property by individuals not for compensation nor in the furtherance of a commercial enterprise;
(4) The transportation of human corpses or sick and injured persons;
(5) The operation of fire trucks and rescue vehicles while involved in emergency and related operations;
(6) The operation of commercial motor vehicles designed or used to transport between 9 and 15 passengers (including the driver), not for direct compensation, provided the vehicle does not otherwise meet the definition of a commercial motor vehicle, except that motor carriers and drivers operating such vehicles are required to comply with §§ 390.15, 390.19T, 390.21T(a) and (b)(2), 391.15(e) and (f), 392.80 and 392.82 of this chapter.
(7) Either a driver of a commercial motor vehicle used primarily in the transportation of propane winter heating fuel or a driver of a motor vehicle used to respond to a pipeline emergency, if such regulations would prevent the driver from responding to an emergency condition requiring immediate response as defined in § 390.5T.
(g)
(1) Part 385, subparts A and E, of this chapter for carriers subject to the requirements of § 385.403 of this chapter.
(2) Part 386 of this chapter, Rules of practice for motor carrier, broker, freight forwarder, and hazardous materials proceedings.
(3) Part 387 of this chapter, Minimum Levels of Financial Responsibility for Motor Carriers, to the extent provided in § 387.3 of this chapter.
(4) Section 390.19T, Motor carrier identification report, and § 390.21T, Marking of CMVs, for carriers subject to the requirements of § 385.403 of this chapter. Intrastate motor carriers operating prior to January 1, 2005, are excepted from § 390.19T(a)(1).
(h)
(1) Subpart F, Intermodal Equipment Providers, of part 385 of this chapter, Safety Fitness Procedures.
(2) Part 386 of this chapter, Rules of Practice for Motor Carrier, Intermodal Equipment Provider, Broker, Freight Forwarder, and Hazardous Materials Proceedings.
(3) This part, Federal Motor Carrier Safety Regulations; General, except § 390.15(b) concerning accident registers.
(4) Part 393 of this chapter, Parts and Accessories Necessary for Safe Operation.
(5) Part 396 of this chapter, Inspection, Repair, and Maintenance.
Unless specifically defined elsewhere, in this subchapter:
(1) Except as provided in paragraph (2) of this definition, an occurrence involving a commercial motor vehicle operating on a highway in interstate or intrastate commerce which results in:
(i) A fatality;
(ii) Bodily injury to a person who, as a result of the injury, immediately receives medical treatment away from the scene of the accident; or
(iii) One or more motor vehicles incurring disabling damage as a result of the accident, requiring the motor vehicle(s) to be transported away from the scene by a tow truck or other motor vehicle.
(2) The term accident does not include:
(i) An occurrence involving only boarding and alighting from a stationary motor vehicle; or
(ii) An occurrence involving only the loading or unloading of cargo.
(1) A threat by a motor carrier, shipper, receiver, or transportation intermediary, or their respective agents, officers or representatives, to withhold business, employment or work opportunities from, or to take or permit any adverse employment action against, a driver in order to induce the driver to operate a commercial motor vehicle under conditions which the driver stated would require him or her to violate one or more of the regulations, which the driver identified at least generally, that are codified at 49 CFR parts 171 through 173, 177 through 180, 380 through 383, or 390 through 399, or § 385.415 or § 385.421T of this chapter,
(2) A threat by a motor carrier, or its agents, officers or representatives, to withhold business, employment or work opportunities or to take or permit any adverse employment action against a driver in order to induce the driver to operate a commercial motor vehicle under conditions which the driver stated would require a violation of one or more of the regulations, which the driver identified at least generally, that are codified at 49 CFR parts 356, 360, or 365 through 379, or the actual withholding of business, employment or work opportunities or the actual taking or permitting of any adverse employment action to punish a driver for refusing to engage in such operation of a commercial motor vehicle.
(1) Has a gross vehicle weight rating or gross combination weight rating, or gross vehicle weight or gross combination weight, of 4,536 kg (10,001 pounds) or more, whichever is greater; or
(2) Is designed or used to transport more than 8 passengers (including the driver) for compensation; or
(3) Is designed or used to transport more than 15 passengers, including the driver, and is not used to transport passengers for compensation; or
(4) Is used in transporting material found by the Secretary of Transportation to be hazardous under 49 U.S.C. 5103 and transported in a quantity requiring placarding under regulations prescribed by the Secretary under 49 CFR, subtitle B, chapter I, subchapter C.
(1) A straight truck or articulated vehicle—
(i) Registered in a State with a license plate or other designation issued by the State of registration that allows law enforcement officials to identify it as a farm vehicle;
(ii) Operated by the owner or operator of a farm or ranch, or an employee or family member of a an owner or operator of a farm or ranch;
(iii) Used to transport agricultural commodities, livestock, machinery or supplies to or from a farm or ranch; and
(iv) Not used in for-hire motor carrier operations; however, for-hire motor carrier operations do not include the operation of a vehicle meeting the requirements of paragraphs (1)(i) through (iii) of this definition by a tenant pursuant to a crop share farm lease agreement to transport the landlord's portion of the crops under that agreement.
(2) Meeting the requirements of paragraphs (1)(i) through (iv) of this definition:
(i) With a gross vehicle weight or gross vehicle weight rating, whichever is greater, of 26,001 pounds or less may utilize the exemptions in § 390.39 anywhere in the United States; or
(ii) With a gross vehicle weight or gross vehicle weight rating, whichever is greater, of more than 26,001 pounds may utilize the exemptions in § 390.39 anywhere in the State of registration or across State lines within 150 air miles of the farm or ranch with respect to which the vehicle is being operated.
(1)
(2)
(ii) Tire disablement without other damage even if no spare tire is available.
(iii) Headlamp or taillight damage.
(iv) Damage to turn signals, horn, or windshield wipers which makes them inoperative.
(1) Between vehicle manufacturer's facilities;
(2) Between a vehicle manufacturer and a dealership or purchaser;
(3) Between a dealership, or other entity selling or leasing the vehicle, and a purchaser or lessee;
(4) To a motor carrier's terminal or repair facility for the repair of disabling damage (as defined in this section) following a crash; or
(5) To a motor carrier's terminal or repair facility for repairs associated with the failure of a vehicle component or system; or
(6) By means of a saddle-mount or tow-bar.
(1) A declaration of an emergency by the President of the United States, the Governor of a State, or their authorized representatives having authority to declare emergencies; by the FMCSA Field Administrator for the geographical area in which the occurrence happens; or by other Federal, State or local government officials having authority to declare emergencies; or
(2) A request by a police officer for tow trucks to move wrecked or disabled motor vehicles.
(1) Controlled and operated by a farmer as a private motor carrier of property;
(2) Being used to transport either—
(i) Agricultural products; or
(ii) Farm machinery, farm supplies, or both, to or from a farm;
(3) Not being used in the operation of a for-hire motor carrier;
(4) Not carrying hazardous materials of a type or quantity that requires the commercial motor vehicle to be placarded in accordance with § 177.823 of this subtitle; and
(5) Being used within 150 air-miles of the farmer's farm.
(1) Are owned by that person; or
(2) Are under the direct control of that person.
(1) A value specified by the manufacturer of the power unit, if such value is displayed on the Federal Motor Vehicle Safety Standard (FMVSS) certification label required by the National Highway Traffic Safety Administration; or
(2) The sum of the gross vehicle weight ratings (GVWRs) or the gross vehicle weights (GVWs) of the power unit and the towed unit(s), or any combination thereof, that produces the highest value. Exception: The GCWR of the power unit will not be used to define a commercial motor vehicle when the power unit is not towing another vehicle.
(1) The act of providing intermodal equipment to a motor carrier pursuant to an intermodal equipment interchange agreement for the purpose of transporting the equipment for loading or unloading by any person or repositioning the equipment for the benefit of the equipment provider, but it does not include the leasing of equipment to a motor carrier for primary use in the motor carrier's freight hauling operations; or
(2) The act of providing a passenger-carrying commercial motor vehicle by one motor carrier of passengers to another such carrier, at a point which both carriers are authorized to serve, with which to continue a through movement.
(3) For property-carrying vehicles, see § 376.2 of this subchapter.
(1) Between a place in a State and a place outside of such State (including a place outside of the United States);
(2) Between two places in a State through another State or a place outside of the United States; or
(3) Between two places in a State as part of trade, traffic, or transportation originating or terminating outside the State or the United States.
(1) For medical examinations conducted before May 21, 2014, a person who is licensed, certified, and/or registered, in accordance with applicable State laws and regulations, to perform physical examinations. The term includes but is not limited to, doctors of medicine, doctors of osteopathy, physician assistants, advanced practice nurses, and doctors of chiropractic.
(2) For medical examinations conducted on and after May 21, 2014, an individual certified by FMCSA and listed on the National Registry of Certified Medical Examiners in accordance with subpart D of this part.
(1) An exemption letter permitting operation of a commercial motor vehicle pursuant to part 381, subpart C, of this chapter or § 391.64 of this chapter;
(2) A skill performance evaluation certificate permitting operation of a commercial motor vehicle pursuant to § 391.49 of this chapter.
(1) Transported outside the driver's compartment of the commercial motor vehicle. For this purpose, the driver's compartment of a passenger-carrying CMV shall include all space designed to accommodate both the driver and the passengers; and
(2) Completely inaccessible to, inoperable by, and imperceptible to the driver while operating the commercial motor vehicle.
(1) This action includes, but is not limited to, short message service, emailing, instant messaging, a command or request to access a World Wide Web page, pressing more than a single button to initiate or terminate a voice communication using a mobile telephone, or engaging in any other form of electronic text retrieval or entry, for present or future communication.
(2) Texting does not include:
(i) Inputting, selecting, or reading information on a global positioning system or navigation system; or
(ii) Pressing a single button to initiate or terminate a voice communication using a mobile telephone; or
(iii) Using a device capable of performing multiple functions (
(1) Full trailer means any motor vehicle other than a pole trailer which is designed to be drawn by another motor vehicle and so constructed that no part of its weight, except for the towing device, rests upon the self-propelled towing motor vehicle. A semitrailer equipped with an auxiliary front axle (converter dolly) shall be considered a full trailer.
(2) Pole trailer means any motor vehicle which is designed to be drawn by another motor vehicle and attached to the towing motor vehicle by means of a “reach” or “pole,” or by being “boomed” or otherwise secured to the towing motor vehicle, for transporting long or irregularly shaped loads such as poles, pipes, or structural members, which generally are capable of sustaining themselves as beams between the supporting connections.
(3) Semitrailer means any motor vehicle, other than a pole trailer, which is designed to be drawn by another motor vehicle and is constructed so that some part of its weight rests upon the self-propelled towing motor vehicle.
(1) Using at least one hand to hold a mobile telephone to conduct a voice communication;
(2) Dialing or answering a mobile telephone by pressing more than a single button; or
(3) Reaching for a mobile telephone in a manner that requires a driver to maneuver so that he or she is no longer in a seated driving position, restrained by a seat belt that is installed in accordance with 49 CFR 393.93 and adjusted in accordance with the vehicle manufacturer's instructions.
(a)
(1) A U.S.-, Canada-, Mexico-, or non-North America-domiciled motor carrier conducting operations in interstate commerce must file a Motor Carrier Identification Report, Form MCS-150.
(2) A motor carrier conducting operations in intrastate commerce and requiring a Safety Permit under 49 CFR part 385, subpart E, must file the Combined Motor Carrier Identification Report and HM Permit Application, Form MCS-150B.
(3) Each intermodal equipment provider that offers intermodal equipment for transportation in interstate commerce must file an Intermodal Equipment Provider Identification Report, Form MCS-150C.
(b)
(1) Before it begins operations; and
(2) Every 24 months, according to the following schedule:
(3) If the next-to-last digit of its USDOT Number is odd, the motor carrier or intermodal equipment provider shall file its update in every odd-numbered calendar year. If the next-to-last digit of the USDOT Number is even, the motor carrier or intermodal equipment provider shall file its update in every even-numbered calendar year.
(4) A person that fails to complete biennial updates to the information pursuant to paragraph (b)(2) of this section is subject to the penalties prescribed in 49 U.S.C. 521(b)(2)(B) or 49 U.S.C. 14901(a), as appropriate, and deactivation of its USDOT Number.
(c)
(d)
(e)
(f) Only the legal name or a single trade name of the motor carrier or intermodal equipment provider may be used on the forms under paragraph (a) of this section (Form MCS-150, MCS-150B, or MCS-150C).
(g) A motor carrier or intermodal equipment provider that fails to file the form required under paragraph (a) of this section, or furnishes misleading information or makes false statements upon the form, is subject to the penalties prescribed in 49 U.S.C. 521(b)(2)(B).
(h)(1) Upon receipt and processing of the form described in paragraph (a) of this section, FMCSA will issue the motor carrier or intermodal equipment provider an identification number (USDOT Number).
(2) The following applicants must additionally pass a pre-authorization safety audit as described below before being issued a USDOT Number:
(i) A Mexico-domiciled motor carrier seeking to provide transportation of property or passengers in interstate commerce between Mexico and points in the United States beyond the municipalities and commercial zones along the United States-Mexico international border must pass the pre-authorization safety audit under § 365.507T of this subchapter. The Agency will not issue a USDOT Number until expiration of the protest period provided in § 365.115 of this subchapter or—if a protest is received—after FMCSA denies or rejects the protest.
(ii) A non-North America-domiciled motor carrier seeking to provide transportation of property or passengers in interstate commerce within the United States must pass the pre-authorization safety audit under § 385.607T(c) of this subchapter. The Agency will not issue a USDOT Number until expiration of the protest period provided in § 365.115 of this subchapter or—if a protest is received—after FMCSA denies or rejects the protest.
(3) The motor carrier must display the number on each self-propelled CMV, as defined in § 390.5T, along with the additional information required by § 390.21T.
(4) The intermodal equipment provider must identify each unit of interchanged intermodal equipment by its assigned USDOT number.
(i) A motor carrier that registers its vehicles in a State that participates in the Performance and Registration Information Systems Management (PRISM) program (authorized under section 4004 of the Transportation Equity Act for the 21st Century [Public Law 105-178, 112 Stat. 107]) is exempt from the requirements of this section, provided it files all the required information with the appropriate State office.
(a)
(b)
(1) The legal name or a single trade name of the motor carrier operating the self-propelled CMV, as listed on the motor carrier identification report (Form MCS-150) and submitted in accordance with § 390.19T.
(2) The identification number issued by FMCSA to the motor carrier or intermodal equipment provider, preceded by the letters “USDOT.”
(3) If the name of any person other than the operating carrier appears on the CMV, the name of the operating carrier must be followed by the information required by paragraphs (b)(1) and (2) of this section, and be preceded by the words “operated by.”
(4) Other identifying information may be displayed on the vehicle if it is not inconsistent with the information required by this paragraph (b).
(c)
(1) Appear on both sides of the self-propelled CMV;
(2) Be in letters that contrast sharply in color with the background on which the letters are placed;
(3) Be readily legible, during daylight hours, from a distance of 50 feet (15.24 meters) while the CMV is stationary; and
(4) Be kept and maintained in a manner that retains the legibility required by paragraph (c)(3) of this section.
(d)
(e)
(1) The CMV is marked in accordance with the provisions of paragraphs (b) through (d) of this section; or
(2) The CMV is marked as set forth in paragraphs (e)(2)(i) through (iv) of this section:
(i) The legal name or a single trade name of the lessor is displayed in accordance with paragraphs (c) and (d) of this section.
(ii) The lessor's identification number preceded by the letters “USDOT” is displayed in accordance with paragraphs (c) and (d) of this section.
(iii) The rental agreement entered into by the lessor and the renting motor carrier conspicuously contains the following information:
(A) The name and complete physical address of the principal place of business of the renting motor carrier;
(B) The identification number issued the renting motor carrier by the FMCSA, preceded by the letters “USDOT,” if the motor carrier has been issued such a number. In lieu of the identification number required in this paragraph (e)(2)(iii)(B), the following may be shown in the rental agreement:
(
(
(C) The sentence: “This lessor cooperates with all Federal, State, and local law enforcement officials nationwide to provide the identity of customers who operate this rental CMV”.
(iv) The rental agreement entered into by the lessor and the renting motor carrier is carried on the rental CMV during the full term of the rental agreement. See the leasing regulations at 49 CFR part 376 for information that should be included in all leasing documents.
(f)
(1) The passenger-carrying CMV is marked in accordance with the provisions of paragraphs (b) through (d) of this section, except that marking is required only on the right (curb) side of the vehicle; and
(2) The passenger-carrying CMV is marked with a single placard, sign, or other device affixed to the right (curb) side of the vehicle on or near the front passenger door. The placard, sign or device must display the legal name or a single trade name of the motor carrier operating the CMV and the motor carrier's USDOT number, preceded by the words “Operated by.”
(g)
(h)
(2) Each unit of intermodal equipment interchanged or offered for interchange to a motor carrier by an intermodal equipment provider subject to this subchapter must identify the intermodal equipment provider.
(3) The intermodal equipment provider must be identified by its legal name or a single trade name and the identification number issued by FMCSA, preceded by the letters “USDOT.”
(4) The intermodal equipment must be identified as follows, using any one of the following methods:
(i) The identification marking must appear on the curb side of the item of equipment. It must be in letters that contrast sharply in color with the background on which the letters are placed. The letters must be readily legible, during daylight hours, from a distance of 50 feet (15.24 meters) while the CMV is stationary; and be kept and maintained in a manner that retains this legibility; or
(ii) The identification marking must appear on a label placed upon the curb side of the item of equipment. The label must be readily visible and legible to an inspection official during daylight hours when the vehicle is stationary. The label must be a color that contrasts sharply with the background on which it is placed, and the letters must also contrast sharply in color with the background of the label. The label must be kept and maintained in a manner that retains this legibility; or
(iii) The USDOT number of the intermodal equipment provider must appear on the interchange agreement so that it is clearly identifiable to an inspection official. The interchange agreement must include additional information to identify the specific item of intermodal equipment (such as the Vehicle Identification Number (VIN) and 4-character Standard Carrier Alpha Code (SCAC) code and 6-digit unique identifying number); or
(iv) The identification marking must be shown on a document placed in a weathertight compartment affixed to the frame of the item of intermodal equipment. The color of the letters used in the document must contrast sharply in color with the background of the document. The document must include additional information to identify the specific item of intermodal equipment (such as the VIN and 4-character SCAC
(v) The USDOT number of the intermodal equipment provider is maintained in a database that is available via real-time internet and telephonic access. The database must:
(A) Identify the name and USDOT number of the intermodal equipment provider responsible for the intermodal equipment, in response to an inquiry that includes:
(
(
(
(B) Offer read-only access for inquiries on individual items of intermodal equipment, without requiring advance user registration, a password, or a usage fee.
An intermodal equipment provider must—
(a) Identify its operations to the FMCSA by filing the Form MCS-150C required by § 390.19T.
(b) Mark its intermodal equipment with the USDOT number as required by § 390.21T before tendering the equipment to a motor carrier.
(c) Systematically inspect, repair, and maintain, or cause to be systematically inspected, repaired, and maintained, in a manner consistent with § 396.3(a)(1) of this chapter, as applicable, all intermodal equipment intended for interchange with a motor carrier.
(d) Provide intermodal equipment intended for interchange that is in safe and proper operating condition.
(e) Maintain a system of driver vehicle inspection reports submitted to the intermodal equipment provider as required by § 396.11 of this chapter.
(f) Maintain a system of inspection, repair, and maintenance records as required by § 396.3(b)(3) of this chapter for equipment intended for interchange with a motor carrier.
(g) Periodically inspect equipment intended for interchange, as required under § 396.17 of this chapter.
(h) At facilities at which the intermodal equipment provider makes intermodal equipment available for interchange, have procedures in place, and provide sufficient space, for drivers to perform a pre-trip inspection of tendered intermodal equipment.
(i) At facilities at which the intermodal equipment provider makes intermodal equipment available for interchange, develop and implement procedures to repair any equipment damage, defects, or deficiencies identified as part of a pre-trip inspection, or replace the equipment, prior to the driver's departure. The repairs or replacement must be made after being notified by a driver of such damage, defects, or deficiencies.
(j) Refrain from placing intermodal equipment in service on the public highways if that equipment has been found to pose an imminent hazard, as defined in § 386.72(b)(3) of this chapter.
(a)
(b)
(c)
“1. The Secretary of a military department, or the Secretary of Homeland Security with regard to the Coast Guard when not operating as a service in the Navy, shall, in the name of the President of the United States, award the Purple Heart, with suitable ribbons and appurtenances, to any member or former member of the armed forces under the jurisdiction of that department who, while serving as a member of the armed forces, has been, or may hereafter be, wounded:
“2. The Secretary of a military department, or the Secretary of Homeland Security with regard to the Coast Guard when not operating as a service in the Navy, shall, in the name of the President of the United States,
“4. The Purple Heart is not authorized for a wound or death that results from the willful misconduct of the member.”.
(b) This order shall be implemented consistent with applicable law and subject to the availability of appropriations.
(c) This order is not intended to, and does not, create any right or benefit, substantive or procedural, enforceable at law or in equity by any party against the United States, its departments, agencies, or entities, its officers, employees, or agents, or any other person.
(d) This order is not intended to, and does not, impair any right or benefit, substantive or procedural, enforceable at law or in equity that arises as a consequence of the designation in section 1 of this order.
(a) revising section 1-204 to read as follows:
“1-204. Agencies or subdivisions of the Department of the Army, Department of Defense:
(1) Headquarters, United States ARCYBER and Second Army.
(2) Joint Forces Headquarters—Cyber.
(3) Army Cyber Operations and Integration Center.
(b) revising section 1-205 to read as follows:
“1-205. Agencies or subdivisions of the Department of the Navy, Department of Defense:
(1) Naval Intelligence Activity.
(2) Office of Naval Intelligence.
(3) Farragut Technical Analysis Center.
(4) Nimitz Operational Intelligence Center.
(5) Hopper Information Services Center.
(6) Kennedy Irregular Warfare Center.
(7) Brooks Center for Maritime Engagement.
(c) revising section 1-206 to read as follows:
“1-206. Agencies or subdivisions of the Department of the Air Force, Department of Defense:
(1) 67th Cyberspace Wing.
(2) 624th Operations Center.
(3) The following subdivisions of the 688th Cyberspace Operations Wing:
(4) 5th Combat Communications Group.
(1) 70th Intelligence, Surveillance and Reconnaissance Wing.
(2) 363rd Intelligence, Surveillance and Reconnaissance Wing.
(3) 480th Intelligence, Surveillance and Reconnaissance Wing.
(4) 625th Operations Center.
(5) The following subdivisions of the 9th Reconnaissance Wing:
(6) 55th Operations Group, 55th Wing.
(1) The following groups of the 1st Special Operations Wing, Hurlburt Field, Florida:
(2) The following groups of the 27th Special Operations Wing, Cannon Air Force Base, New Mexico:
(d) revising section 1-207 to read as follows:
“1-207. Defense Intelligence Agency, Department of Defense.”;
(e) revising section 1-208 to read as follows:
“1-208. Defense Security Service, Department of Defense.”;
(f) revising section 1-212 to read as follows:
“1-212. Agencies or subdivisions under the authority of the Chairman of the Joint Chiefs of Staff and the Commanders of the Combatant Commands, Department of Defense.
(1) United States Cyber Command (USCYBERCOM).
(2) Joint Functional Component Command—Global Strike (JFCC GS).
(3) Joint Functional Component Command—Space (JFCC Space).
(4) Joint Functional Component Command—Integrated Missile Defense (JFCC IMD).
(5) Joint Functional Component Command—Intelligence, Surveillance and Reconnaissance (JFCC ISR).
(6) USSTRATCOM Center for Combating Weapons of Mass Destruction (SCC WMD).
(7) Standing Joint Force Headquarters for Elimination (SJFHQ-E).
(8) Joint Warfare Analysis Center (JWAC).
(1) Components:
(i) The following groups of the 1st Special Operations Wing, Hurlburt Field, Florida:
(ii) The following groups of the 27th Special Operations Wing, Cannon Air Force Base, New Mexico:
(2) Sub-unified Commands:
(g) revising section 1-215 to read as follows:
“Sec. 1-215. National Geospatial-Intelligence Agency (NGA), Department of Defense.”; and
(h) inserting after section 1-216 the following new sections:
(a) Defense Logistics Agency Intelligence.
(b) Joint Logistics Operations Center.
(c) Computer Emergency Response Team and Incident Response Branch.
(b) This order shall be implemented consistent with applicable law and subject to the availability of appropriations.
(c) This order is not intended to, and does not, create any right or benefit, substantive or procedural, enforceable at law or in equity by any party against the United States, its departments, agencies, or entities, its officers, employees, or agents, or any other person.
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration |