| Page Range | 47547-47799 | |
| FR Document |
| Page and Subject | |
|---|---|
| 83 FR 47799 - Continuation of the National Emergency With Respect to Persons Who Commit, Threaten To Commit, or Support Terrorism | |
| 83 FR 47795 - Delegation of Authorities Under the Reinforcing Education Accountability in Development Act | |
| 83 FR 47791 - Modernizing the Monetary Reimbursement Model for the Delivery of Goods Through the International Postal System and Enhancing the Security and Safety of International Mail | |
| 83 FR 47616 - Sunshine Act Meetings | |
| 83 FR 47615 - Sunshine Act Meetings | |
| 83 FR 47609 - Sunshine Act Meetings | |
| 83 FR 47651 - Sunshine Act Meetings; Temporary Emergency Committee of the Board of Governors | |
| 83 FR 47608 - Sunshine Act Meetings | |
| 83 FR 47638 - Notice of Intent To Prepare a Draft Environmental Impact Statement for the Rose Hill Courts Redevelopment | |
| 83 FR 47614 - Privacy Act of 1974; System of Records; Correction | |
| 83 FR 47592 - Endangered and Threatened Wildlife; Positive 90-Day Finding on a Petition To List the Cauliflower Coral, Pocillopora Meandrina, | |
| 83 FR 47607 - Meeting of the Columbia Basin Partnership Task Force of the Marine Fisheries Advisory Committee | |
| 83 FR 47620 - Privacy Act of 1974; Matching Program | |
| 83 FR 47608 - Agency Information Collection Activities Under OMB Review | |
| 83 FR 47608 - Technology Advisory Committee; Meeting | |
| 83 FR 47611 - Arms Sales Notification | |
| 83 FR 47619 - Medicare Program; Medicare Appeals; Adjustment to the Amount in Controversy Threshold Amounts for Calendar Year 2019 | |
| 83 FR 47634 - Notice of New NIH Policy Manual 1311-Preventing and Addressing Harassment and Inappropriate Conduct and New Policy Statement on Inappropriate Relationships in the Workplace | |
| 83 FR 47639 - Notice of Proposed Reinstatement of Terminated Oil and Gas Leases in Ohio | |
| 83 FR 47622 - Grandfathering Policy for Packages and Homogenous Cases of Product Without a Product Identifier; Guidance for Industry; Availability | |
| 83 FR 47626 - Product Identifiers Under the Drug Supply Chain Security Act Questions and Answers; Draft Guidance for Industry; Availability | |
| 83 FR 47640 - Notice of Proposed Reinstatement of Terminated Oil and Gas Leases in Wyoming (Southland 17) | |
| 83 FR 47560 - Drawbridge Operation Regulation; Atlantic Intracoastal Waterway, Palm Beach, FL | |
| 83 FR 47643 - Notice Pursuant to the National Cooperative Research and Production Act of 1993-PXI Systems Alliance, Inc. | |
| 83 FR 47604 - Agenda and Notice of Public Meeting of the Colorado Advisory Committee | |
| 83 FR 47642 - Notice Pursuant to the National Cooperative Research and Production Act of 1993-Advanced Media Workflow Association, Inc. | |
| 83 FR 47650 - New Postal Products | |
| 83 FR 47673 - Audit and Financial Management Advisory Committee (AFMAC) | |
| 83 FR 47651 - Notice of Public Meeting | |
| 83 FR 47674 - Audit and Financial Management Advisory Committee (AFMAC) | |
| 83 FR 47613 - Proposed Collection; Comment Request | |
| 83 FR 47609 - Proposed Collection; Comment Request | |
| 83 FR 47610 - Submission for OMB Review; Comment Request | |
| 83 FR 47629 - Government-Owned Inventions; Availability for Licensing | |
| 83 FR 47637 - National Center for Complementary & Integrative Health; Amended Notice of Meeting | |
| 83 FR 47616 - Supplemental Evidence and Data Request on Depression in Children: Systematic Review | |
| 83 FR 47569 - Approval and Promulgation of Implementation Plans; Arkansas; Interstate Transport Requirements for the 2012 PM2.5 | |
| 83 FR 47606 - Marine Mammals and Endangered Species | |
| 83 FR 47606 - Marine Mammals; File No. 21425 | |
| 83 FR 47648 - Protection Against Malevolent Use of Vehicles at Nuclear Power Plants | |
| 83 FR 47682 - Advisory Committee on Prosthetics and Special-Disabilities Programs; Notice of Meeting | |
| 83 FR 47574 - Capital Leases | |
| 83 FR 47641 - Certain Network Devices, Related Software and Components Thereof (I): Commission Decision To Terminate the Enforcement Proceeding Based on Settlement | |
| 83 FR 47623 - Heparin-Containing Medical Devices and Combination Products: Recommendations for Labeling and Safety Testing; Guidance for Industry and Food and Drug Administration Staff; Availability | |
| 83 FR 47547 - Tax Withholding on Court Ordered Payments | |
| 83 FR 47645 - Notice of Permit Applications Received Under the Antarctic Conservation Act of 1978 | |
| 83 FR 47605 - New England Fishery Management Council; Public Meeting | |
| 83 FR 47605 - Pacific Fishery Management Council; Public Meeting | |
| 83 FR 47605 - Gulf of Mexico Fishery Management Council; Public Meeting | |
| 83 FR 47678 - Requested Administrative Waiver of the Coastwise Trade Laws: Vessel RICHARD H. DANA; Invitation for Public Comments | |
| 83 FR 47676 - Requested Administrative Waiver of the Coastwise Trade Laws: Vessel REBEL SOUL; Invitation for Public Comments | |
| 83 FR 47677 - Requested Administrative Waiver of the Coastwise Trade Laws: Vessel ONE IRON; Invitation for Public Comments | |
| 83 FR 47681 - Requested Administrative Waiver of the Coastwise Trade Laws: Vessel OCEAN SPIRIT; Invitation for Public Comments | |
| 83 FR 47681 - Requested Administrative Waiver of the Coastwise Trade Laws: Vessel MISS BROOKE; Invitation for Public Comments | |
| 83 FR 47679 - Requested Administrative Waiver of the Coastwise Trade Laws: Vessel GIOVANNINO; Invitation for Public Comments | |
| 83 FR 47680 - Requested Administrative Waiver of the Coastwise Trade Laws: Vessel FIRST WAVE; Invitation for Public Comments | |
| 83 FR 47598 - Atlantic Highly Migratory Species; Shortfin Mako Shark Management Measures; Proposed Amendment 11; Comment Period Extension | |
| 83 FR 47614 - Agency Information Collection Activities; Comment Request; Borrower Defenses Against Loan Repayment | |
| 83 FR 47562 - Safety Zone; C&S Worldwide Holdings Inc. Fireworks, Lake Ontario, Oswego, NY | |
| 83 FR 47646 - Proposal Review Panel for International Science and Engineering; Notice of Meeting | |
| 83 FR 47646 - Advisory Committee for Education and Human Resources; Notice of Meeting | |
| 83 FR 47600 - Meeting Notice of the National Agricultural Research, Extension, Education, and Economics Advisory Board | |
| 83 FR 47647 - Proposed Revisions to Branch Technical Position 5-3: Fracture Toughness Requirements | |
| 83 FR 47648 - Entergy Nuclear Operations, Inc.: Indian Point Nuclear Generating Unit Nos. 2 and 3 | |
| 83 FR 47600 - Notice of Request for Revision to and Extension of Approval of an Information Collection; Importation of Fresh Peppers From Peru Into the Continental United States and the Territories | |
| 83 FR 47566 - Air Quality State Implementation Plans; Approvals and Promulgations: Infrastructure Monitoring Requirements for the 2008 Pb, 2010 SO2 | |
| 83 FR 47564 - Approval and Promulgation of Air Quality Implementation Plans; Wyoming; Incorporation by Reference Updates | |
| 83 FR 47619 - Performance Review Board Members | |
| 83 FR 47625 - Product Identifier Requirements Under the Drug Supply Chain Security Act-Compliance Policy; Guidance for Industry; Availability | |
| 83 FR 47601 - Codex Alimentarius Commission: Meeting of the Codex Committee on Nutrition and Foods for Special Dietary Uses (CCNFSDU) | |
| 83 FR 47603 - Codex Alimentarius Commission: Meeting of the Codex Committee on Food Hygiene (CCFH) | |
| 83 FR 47640 - Forged Steel Fittings From Taiwan | |
| 83 FR 47651 - Product Change-Parcel Select Negotiated Service Agreement | |
| 83 FR 47654 - Self-Regulatory Organizations; Cboe EDGA Exchange, Inc.; Notice of Filing and Immediate Effectiveness of a Proposed Rule Change To Amend Its Rules Relating to Categories of Registration and Respective Qualification Examinations Required for Members That Engage in Trading Activities on the Exchange | |
| 83 FR 47654 - Self-Regulatory Organizations; NYSE Arca, Inc.; Notice of Designation of a Longer Period for Commission Action on a Proposed Rule Change Regarding Investments of the First Trust TCW Unconstrained Plus Bond ETF | |
| 83 FR 47643 - Agency Information Collection Activities; Comment Request; Data Collections From Industry-Recognized Apprenticeship Program Accreditors | |
| 83 FR 47666 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing and Immediate Effectiveness of a Proposed Rule Change To Amend Rule 2360 (Options) To Increase Position Limits on Options on Certain Exchange-Traded Funds | |
| 83 FR 47665 - Self-Regulatory Organizations; ICE Clear Credit LLC; Order Approving Proposed Rule Change Relating to the Clearance of an Additional Credit Default Swap Contract | |
| 83 FR 47663 - Self-Regulatory Organizations; Cboe Exchange, Inc.; Notice of Filing and Immediate Effectiveness of a Proposed Rule Change Relating To Amend Its Rules Relating to Categories of Registration and Respective Qualification Examinations Required for Trading Permit Holders (“TPHs”) and Associated Persons That Engage in Trading Activities on the Exchange | |
| 83 FR 47659 - Self-Regulatory Organizations; Cboe BZX Exchange, Inc.; Order Granting Approval of a Proposed Rule Change, as Modified by Amendment No. 3, To List and Trade Shares of Eighteen ADRPLUS Funds of the Precidian ETFs Trust Under Rule 14.11(i), Managed Fund Shares | |
| 83 FR 47651 - Self-Regulatory Organizations; Cboe C2 Exchange, Inc.; Notice of Filing and Immediate Effectiveness of a Proposed Rule Change Relating To Amend Its Rules Relating to Categories of Registration and Respective Qualification Examinations Required for Trading Permit Holders (“TPHs”) and Associated Persons That Engage in Trading Activities on the Exchange | |
| 83 FR 47591 - Hours of Service of Drivers | |
| 83 FR 47641 - Notice of Receipt of Complaint; Solicitation of Comments Relating to the Public Interest | |
| 83 FR 47628 - Health Resources and Services Administration Meeting of the Advisory Committee on Heritable Disorders in Newborns and Children | |
| 83 FR 47589 - Hours of Service | |
| 83 FR 47645 - NASA Astrophysics Advisory Committee; Meeting | |
| 83 FR 47632 - National Institute of General Medical Sciences; Notice of Closed Meeting | |
| 83 FR 47630 - National Institute of Dental & Craniofacial Research; Notice of Closed Meetings | |
| 83 FR 47633 - National Institute on Drug Abuse; Notice of Closed Meetings | |
| 83 FR 47633 - National Institute of Allergy and Infectious Diseases Notice of Closed Meeting | |
| 83 FR 47630 - National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting | |
| 83 FR 47634 - National Institute on Aging; Notice of Closed Meeting | |
| 83 FR 47635 - National Cancer Institute Notice of Closed Meetings | |
| 83 FR 47629 - National Cancer Institute; Notice of Meeting | |
| 83 FR 47635 - Center for Scientific Review; Notice of Closed Meetings | |
| 83 FR 47630 - Center for Scientific Review; Amended Notice of Meeting | |
| 83 FR 47632 - Center for Scientific Review; Notice of Closed Meetings | |
| 83 FR 47630 - Center for Scientific Review; Notice of Closed Meetings | |
| 83 FR 47637 - Revision of Agency Information Collection Activity Under OMB Review: TSA Claims Application | |
| 83 FR 47657 - Exact Sciences Corporation | |
| 83 FR 47673 - Presidential Declaration of a Major Disaster for Public Assistance Only for the State of ALASKA | |
| 83 FR 47673 - Presidential Declaration of a Major Disaster for Public Assistance Only for the State of Minnesota | |
| 83 FR 47578 - Proposed Amendment of Class D Airspace; Pontiac, MI | |
| 83 FR 47580 - Proposed Amendment of Class D Airspace; Detroit, MI | |
| 83 FR 47585 - Proposed Amendment of Class D and E Airspace and Revocation of Class E Airspace; Fayetteville, AR | |
| 83 FR 47583 - Proposed Amendment of Class E Airspace; Cabool, MO | |
| 83 FR 47644 - Notice of Publication of 2018 Update to the Department of Labor's List of Goods Produced by Child Labor or Forced Labor | |
| 83 FR 47568 - Air Plan Approval; Washington; Interstate Transport Requirements for the 2015 Ozone NAAQS | |
| 83 FR 47557 - Food Additives Permitted for Direct Addition to Food for Human Consumption; Vitamin D3 | |
| 83 FR 47674 - New Special Experimental Project (SEP-16) To Evaluate Proposals for Delegation of Certain Program-Wide FHWA Responsibilities to States | |
| 83 FR 47587 - Special Regulations, Areas of the National Park System, Death Valley National Park; Designation of Airstrip | |
| 83 FR 47572 - Approval of Missouri Air Quality Implementation Plans; Redesignation of the Missouri Portion of the St. Louis-St. Charles-Farmington, MO-IL 2008 Ozone Area to Attainment | |
| 83 FR 47577 - Proposed Amendment of Class E Airspace, Mountain City, TN; and Proposed Establishment of Class E Airspace; Elizabethton, TN | |
| 83 FR 47581 - Proposed Establishment of Class E Airspace, and Amendment of Class D Airspace and Class E Airspace; Dothan, AL | |
| 83 FR 47548 - Transport Airplane Fuel Tank and System Lightning Protection | |
| 83 FR 47764 - Lease and Interchange of Vehicles; Motor Carriers of Passengers | |
| 83 FR 47686 - Medicare and Medicaid Programs; Regulatory Provisions To Promote Program Efficiency, Transparency, and Burden Reduction |
Animal and Plant Health Inspection Service
The U.S. Codex Office
National Oceanic and Atmospheric Administration
Army Department
Navy Department
Federal Energy Regulatory Commission
Agency for Healthcare Research and Quality
Centers for Disease Control and Prevention
Centers for Medicare & Medicaid Services
Food and Drug Administration
Health Resources and Services Administration
National Institutes of Health
Coast Guard
Transportation Security Administration
Land Management Bureau
National Park Service
Antitrust Division
Employment and Training Administration
Federal Aviation Administration
Federal Highway Administration
Federal Motor Carrier Safety Administration
Federal Transit Administration
Maritime Administration
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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Federal Retirement Thrift Investment Board.
Direct final rule.
This rule deletes regulatory language that provides for the Federal income tax withholding rates on court ordered payments from the Thrift Savings Plan.
This rule is effective without further action on October 22, 2018, unless significant adverse comment is received by October 15, 2018. If significant adverse comment is received, the FRTIB will publish a timely withdrawal of the rule in the
You may submit comments using one of the following methods:
•
•
•
•
The most helpful comments explain the reason for any recommended change and include data, information, and the authority that supports the recommended change.
Laurissa Stokes at (202) 942-1645.
The FRTIB administers the Thrift Savings Plan (TSP), which was established by the Federal Employees' Retirement System Act of 1986 (FERSA), Public Law 99-335, 100 Stat. 514. The TSP provisions of FERSA are codified, as amended, largely at 5 U.S.C. 8351 and 8401-79. The TSP is a tax-deferred retirement savings plan for Federal civilian employees and members of the uniformed services. The TSP is similar to cash or deferred arrangements established for private-sector employees under section 401(k) of the Internal Revenue Code (26 U.S.C. 401(k)).
Currently, paragraph (e) of 5 CFR 1635.5 specifies the person to whom a court ordered payment from the TSP may be made and, in addition, specifies the Federal income tax withholding rates on such payments. This rule deletes the language that specifies the Federal income tax withholding rates on court ordered TSP payments.
The Federal income tax withholding rates on all TSP payments are dictated by the Internal Revenue Code. As such, any FRTIB regulatory language that expresses the withholding rates are, at best, duplicative of the Internal Revenue Code. The Federal income tax withholding rates required by the Internal Revenue Code are more appropriately communicated to participants and beneficiaries via the TSP website or via forms and publications provided directly to them.
In a direct final rulemaking, an agency publishes a direct final rule in the
I certify that this regulation will not have a significant economic impact on a substantial number of small entities. This regulation will affect Federal employees and members of the uniformed services who participate in the Thrift Savings Plan, which is a Federal defined contribution retirement savings plan created under the Federal Employees' Retirement System Act of 1986 (FERSA), Public Law 99-335, 100 Stat. 514, and which is administered by the FRTIB.
I certify that these regulations do not require additional reporting under the criteria of the Paperwork Reduction Act.
Pursuant to the Unfunded Mandates Reform Act of 1995, 2 U.S.C. 602, 632, 653, 1501-1571, the effects of this regulation on state, local, and tribal governments and the private sector have been assessed. This regulation will not compel the expenditure in any one year of $100 million or more by state, local, and tribal governments, in the aggregate, or by the private sector. Therefore, a statement under section 1532 is not required.
Pursuant to 5 U.S.C. 810(a)(1)(A), the Agency submitted a report containing this rule and other required information to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States before publication of this rule in the
Alimony, Child support, Government employees, Pensions, Retirement.
For the reasons stated in the preamble, the Agency amends 5 CFR chapter VI as follows:
5 U.S.C. 8432d, 8435, 8436(b), 8437(e), 8439(a)(3), 8467, 8474(b)(5) and 8474(c)(1).
(e) Payment will be made only to the person or persons specified in the court order. However, if the court order specifies a third-party mailing address for the payment, the TSP will mail to the address specified any portion of the payment that is not transferred to a traditional IRA, Roth IRA, or eligible employer plan.
Federal Aviation Administration (FAA), DOT.
Final rule.
The FAA is amending certain airworthiness regulations for transport category airplanes regarding lightning protection of fuel systems. This action is relieving in several ways. It removes the requirement for manufacturers to provide triple-redundant fault tolerance in lightning protection. It removes regulatory inconsistency by establishing a single standard for lightning protection of both fuel tank structure and fuel tank systems. It establishes a performance-based standard that the design and installation of fuel systems prevent catastrophic fuel vapor ignition caused by lightning and its effects. This performance-based standard allows applicants to choose how to provide the required level of safety. This action requires airworthiness limitations to preclude the degradation of design features that prevent catastrophic fuel vapor ignition caused by lightning. Its intended effects are to align airworthiness standards with industry's and the FAA's understanding of lightning, and to address issues of inconsistency and impracticality that applicants experienced with previous lightning protection regulations.
Effective November 19, 2018.
For information on where to obtain copies of rulemaking documents and other information related to this final rule, see “How To Obtain Additional Information” in the
For questions concerning this action, contact Stephen Slotte, Airplane and Flight Crew Interface Section, AIR-671, Transport Standards Branch, Policy and Innovation Division, Aircraft Certification Service, Federal Aviation Administration, 2200 South 216th Street, Des Moines, WA 98198; telephone and fax (206) 231-3163; email
The FAA's authority to issue rules on 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 III, Section 44701, “General Requirements.” Under that section, the FAA is charged with promoting safe flight of civil aircraft in air commerce by prescribing regulations and minimum standards for the design and performance of aircraft that the Administrator finds necessary for safety in air commerce. This regulation is within the scope of that authority. It prescribes revised safety standards for the design and operation of transport category airplanes.
The FAA is amending the airworthiness regulations in title 14, Code of Federal Regulations (14 CFR) part 25 related to the lightning protection of fuel systems
This amendment removes lightning from the ignition sources regulated by § 25.981(a)(3). Inclusion of lightning in that section has resulted in applicants showing that compliance was impractical, leading them to seek exemptions to compliance with § 25.981 for fuel tank structure and systems. The FAA has granted several exemptions for fuel tank structure and systems. The FAA agrees, however, with the Large Airplane Fuel System Lightning Protection Aviation Rulemaking Committee (Lightning ARC)
To maintain the integrity of lightning protection features of airplanes, this amendment adds a new paragraph (d) to § 25.954 and amends part 25, appendix H, section H25.4(a) to require applicants to establish airworthiness limitations to protect the continued function of the lightning protection features of fuel tank structure and fuel systems.
This rule applies to applications for new type certificates, and applications for amended or supplemental type certificates on significant product-level change projects in which § 25.954, “Fuel system lightning protection,” is applicable to the changed area.
Section 25.954, adopted in 1967, required protection of the airplane from the effects of lightning, regardless of the likelihood that lightning would strike the airplane. The regulation did not acknowledge that lightning protection
Compliance with § 25.981(a)(3), at amendment 25-102,
On May 26, 2009, the FAA issued a policy memorandum to standardize the process for granting exemptions and issuing special conditions for fuel tank structure lightning protection. FAA Policy Memorandum ANM-112-08-002, “Policy on Issuance of Special Conditions and Exemptions Related to Lightning Protection of Fuel Tank Structure,” defined alternative methods that could be applied through special conditions or exemptions to some areas of structural designs where compliance with § 25.981(a)(3) was impractical. This policy allowed the applicant's risk assessment to account for the reduced likelihood of the simultaneous occurrence of a critical lightning strike and a fuel tank being flammable. The policy explained the level of safety intended by § 25.981(a)(3) for fuel tank structure, and provided guidance for alternatives to compliance that still achieve that level of safety.
On June 24, 2014, the FAA superseded that policy memorandum with Policy Statement PS-ANM-25.981-02, “Policy on Issuance of Special Conditions and Exemptions Related to Lightning Protection of Fuel Tank Structure and Systems,” expanding the scope of the policy to include systems. The policy statement provided guidance for approval of special conditions and exemptions for lightning protection features in fuel tank structure and fuel systems with respect to § 25.981(a)(3).
The revisions to § 25.981(a)(3) in this amendment should eliminate the need to issue such special conditions and exemptions. However, some of the information in that policy statement will remain in Advisory Circular (AC) 25.981-1D, “Fuel Tank Ignition Source Prevention Guidelines,”
The final rule will maintain the level of safety established by these policies. It codifies these policies into a performance-based rule that allows the applicant to choose the means of compliance.
On December 9, 2014, the FAA issued a notice of proposed rulemaking (NPRM) to amend §§ 25.954 and 25.981 and appendix H to part 25. The
• Consolidate the requirements for the prevention of fuel vapor ignition due to lightning, currently in §§ 25.954 and 25.981, into § 25.954;
• Retain and renumber the existing rule text;
• Add lightning-induced or conducted electrical transients
• Add a new performance-based standard to require that a catastrophic fuel tank explosion be extremely improbable when taking into account the risk of failures, probability of a critical lightning strike, and fuel tank flammability exposure;
• Add maintenance requirements to maintain the integrity of lightning protection features during the airplane service life; and
• Define critical lightning strike and fuel system.
• Remove the requirement to prevent lightning ignition sources and instead refer applicants to § 25.954 for lightning protection requirements;
• Clarify that the applicant must provide critical design control configuration limitations (CDCCLs) to identify critical design features in addition to inspections or other procedures; and
• Change the title to “Fuel tank explosion prevention.”
• Add a new paragraph to make mandatory any inspection and test procedures that are needed to sustain the integrity of the lightning protection design features used to show compliance with § 25.954; and
• Add a new section to require applicants to develop ICA that protect the lightning protection features required by § 25.954.
The FAA proposed these changes based on recommendations from the Lightning ARC. The comment period closed on March 18, 2015.
The FAA received comments from eight (8) manufacturers and one (1) industry group. All of the commenters generally supported the proposed amendments. Some of the comments suggested changes.
In the discussion below, some comments identify paragraph designations of the rules as proposed in the NPRM. In this final rule, the FAA is revising and reorganizing some of those paragraphs, so paragraph references in the comments may be different from their designation in the final rule. This section references each paragraph according to its designation in this final rule, with the NPRM paragraph designation noted in brackets when there has been a change.
With some differences from what the FAA proposed in the NPRM, this amendment requires that the design and installation of the airplane fuel system
To comply with the revised § 25.954, this amendment requires applicants to show that catastrophic fuel vapor ignition is extremely improbable, taking into account flammability, critical lightning strikes, and failures within the fuel system.
To protect those features of the airplane that prevent catastrophic fuel vapor ignition due to lightning, this amendment adds a requirement that the type design include CDCCLs identifying those features and providing information to protect them. To ensure the continued effectiveness of those features, the rule requires that the type design specify necessary inspections and test procedures, intervals between repetitive inspections and tests, and mandatory replacement times. The rule also requires the applicant to include information regarding CDCCLs and methods for ensuring continued effectiveness of lightning protection features in the Airworthiness Limitations section (ALS) of the ICA.
The following is a discussion of comments the FAA received on the changes to § 25.954 as they were proposed in the NPRM.
The NPRM proposed adding definitions of “critical lightning strike” and “fuel system” to § 25.954(d). This final rule revises these definitions and moves them to paragraph (a) of the section.
The AE-2 and WG-31 Lightning Committees (SAE Lightning Group) supported the proposed definition of “fuel system.” However, the FAA determined that the inclusion of the word “other” in the definition, “A fuel system includes any component within either the fuel tank structure or the fuel tank systems, and any
The proposed definition of a “critical lightning strike” was “. . . a lightning strike that attaches to the airplane in a location that affects a failed feature or a structural failure, and the amplitude of the strike is sufficient to create an ignition source when combined with that failure.” The SAE Lightning Group requested changes to this definition for clarity. The commenter requested that the term “failed feature” be changed to “failed protection feature,” but did not provide a rationale. The commenter also stated that it is unnecessary to list structural failures separately. The commenter further stated that the inclusion of “a failed [protection] feature” already includes structural failures, which otherwise could result in an ignition source. The commenter also suggested revising the definition to, “A critical lightning strike is a lightning strike that attaches to the airplane in a location that affects a failed protection feature with characteristics that could create an ignition source when combined with that failure.”
The FAA partially agrees with the SAE Lightning Group's requests. The FAA modified the definition of critical lightning strike by deleting “the amplitude of the strike is sufficient,” but did not replace that text with “characteristics that could,” as the commenter recommended. The definition is clear without either of those phrases. The FAA also did not replace “failed feature” with “failed protection feature,” or delete the phrase “structural failure.” To address the comments, we have revised the definition by removing the phrase “failed feature” and stating instead that, “A critical lightning strike is a lightning strike that attaches to the airplane in a location that, when combined with the failure of any design feature or structure, could create an ignition source.”
In this revised definition, a “design feature” means any feature specifically designed for lightning protection or any other design feature whose failure, when combined with a lightning strike, could cause ignition. An example of a design feature that is specifically designed for lightning protection is a metal foil layer installed between the laminate layers of a composite wing. An example of a design feature that is not specifically designed for lightning protection but whose failure, when combined with a lightning strike, could cause ignition is a swaged fitting on a hydraulic tube located within the fuel tank. Structural failures that could create an ignition source in the event of a lightning strike must also be addressed and, therefore, the final definition includes “any design feature or structure.”
Related to the definition of critical lightning strike, the NPRM stated that a critical lightning strike occurs “on the order of once every 100,000 hours of airplane operation.” The SAE Lightning Group commented that the location of the lightning's attachment to the airplane, whether the strike's amplitude is sufficient to create an ignition source, and the effect of a failed feature or structural failure are all design-dependent. The SAE Lightning Group also commented that compliance with § 25.954 would require use of a strike rate of 1 in 100,000 hours. The commenter suggested that the FAA should allow applicants to identify how often a critical lightning strike might occur relative to their designs.
The intent of the statement in the NPRM that a critical lightning strike occurs once per 100,000 hours was to provide a general understanding of their average rate of occurrence. It was not intended as a rate to be used in demonstrating compliance. The FAA agrees with the SAE Lightning Group that the actual rate of a critical strike would be based on an applicant's analysis of the specific airplane design features, which include additional factors such as location of the strike, characteristics of the lightning strike, failure of design features and structure, and specific ignition source thresholds for each feature failure and failure mode.
Related to this same discussion in the NPRM, Parker Aerospace (“Parker”) requested that the FAA add a paragraph to § 25.954 that describes all of the conditions and guidance regarding probabilities that the applicant must consider, such as flammability exposure and failure latency of inerting systems. The FAA disagrees with Parker's request. Rather than make such conditions and guidance on probabilities mandatory via a new paragraph in § 25.954, such guidance is included in AC 25.954-1, “Transport Airplane Fuel System Lightning Protection.”
The SAE Lightning Group suggested that the FAA clearly state that the revised § 25.954 takes precedence over the general requirements of §§ 25.901,
The NPRM proposed adding “lightning-induced or conducted electrical transients” to the lightning effects in § 25.954(b) [paragraph (a) in the NPRM] that applicants must ensure will not cause ignition of fuel vapor within the fuel system. The SAE Lightning Group recommended that, rather than adding to the existing list of lightning threats in the rule, the FAA delete the list of lightning effects. Instead, the SAE Lightning Group recommended that the rule include a more general and inclusive reference to lightning that requires that the airplane be protected against catastrophic effects from lightning. The SAE Lightning Group suggested that the list may not be complete and may be inconsistent with lightning environments defined in the industry documents accepted by the FAA in AC 20-155A, “Industry Documents to Support Aircraft Lightning Protection Certification.” In contrast, Parker supported keeping the text as proposed, including “lightning-induced or conducted electrical transients.”
The FAA disagrees with the SAE Lightning Group's suggestion to include only a general lightning requirement. Relying on guidance material to detail the lightning effects that applicants must consider could result in some applicants not addressing all effects. However, the FAA recognizes that the list of effects, as proposed, could be misinterpreted as an exhaustive list. Therefore, the FAA added “including” to the text that introduces the list to clarify that the list is not exhaustive. The FAA agrees to limit, in § 25.954(b), the type of fuel vapor ignition that must be prevented to “catastrophic” events. This change will make the requirement consistent with Policy Statement PS-ANM-25.981-02, which states that “the fuel tank structure and systems must be designed and installed to prevent catastrophic fuel vapor ignition due to lightning.” This change also makes § 25.954(b) consistent with § 25.581, which requires that the airplane be protected against “catastrophic” effects from lightning. Thus, § 25.954(b) now states, “The design and installation of a fuel system must prevent catastrophic fuel vapor ignition due to lightning and its effects, including . . . .”
The SAE Lightning Group recommended the removal of “corona and streamering at fuel vent outlets” from the list of lightning effects because that term is inconsistent with the terminology in the industry guidance material recommended by AC 20-155A. The FAA agrees and has removed this term from the final rule.
Regarding § 25.954(c) [paragraph (b) in the NPRM], the SAE Lightning Group requested that the FAA require that catastrophic fuel vapor ignition due to lightning be prevented by demonstrating that the fuel system ignition source protection design is fault tolerant, or for designs that are not fault tolerant, by showing catastrophic fuel vapor ignition to be extremely improbable, taking into account flammability, critical lightning strikes, and failures in the fuel system. The SAE Lightning Group argued that the proposed broader requirement to show that catastrophic ignition is extremely improbable, without requiring a fault tolerant design, would be costly and would negate the savings to industry stated in the regulatory evaluation. In a related comment, Bombardier S.A. (Bombardier) requested that “fault tolerant” be defined to clarify if it is equivalent to single fault tolerance and the type of compliance that the FAA would expect, numerical analysis or qualitative. Although the term was not used in the proposed rule (and is not in the final rule), Bombardier suggested more clarity was needed in the rule and supporting guidance.
The FAA agrees that fuel systems designed with reliable fault-tolerant ignition source protection features should comply with the requirement that catastrophic fuel vapor ignition be extremely improbable. As used in this context, a fault-tolerant fuel system design is a design that precludes ignition sources in the fuel system even when a fault is present; “reliable” means the ability to maintain the effectiveness of the protection features over the service life of the individual airplane.
However, the FAA disagrees that fault tolerance should be required because fault tolerance is only one possible means of compliance with the requirement that catastrophic fuel vapor ignition be extremely improbable. The use of a full-time flammability control system (
Regardless of the design approach chosen by the applicant to prevent lightning-induced catastrophic fuel vapor ignition, a safety analysis will be necessary to demonstrate extreme improbability. The complexity of the analysis can range from a relatively simple assessment to establish any maintenance requirements for reliable fault-tolerant ignition protection features, to a more in-depth analysis if non-fault-tolerant design features are used. For reliable fault-tolerant features, this analysis would be substantially less costly than traditional methods for showing that catastrophic failures are extremely improbable. The supporting AC 25.954-1 provides guidance on methods for both fault-tolerant and FRM compliance approaches, including the necessary safety assessment, which could be numerical, qualitative, or a combination of the two.
The FAA disagrees with Bombardier's request to define fault-tolerant in § 25.954. Since a fault-tolerant design is not a requirement for compliance with this rule, there is no need to provide a regulatory definition. However, the supporting AC 25.954-1 includes the definition for fault-tolerant design noted earlier in this section (4. Fault-Tolerant Design), “A fault-tolerant fuel system design is a design that precludes ignition sources in the fuel system even when a fault is present.”
Therefore, this amendment retains the requirement in § 25.954(c) that catastrophic fuel vapor ignition be extremely improbable, and clarifies its relationship with paragraph (b). The revised § 25.954(c) states, “To comply with paragraph (b) of this section, catastrophic fuel vapor ignition must be extremely improbable, taking into account flammability, critical lightning strikes, and failures within the fuel system.”
The SAE Lightning Group also commented that the FAA should revise the regulatory evaluation if the FAA does not adopt the SAE Lightning Group's recommendation to replace the requirement of extreme improbability with fault tolerance. The commenter argued that the requirement to show that fuel tank ignition is extremely improbable would be costly and negate the savings to industry shown in the regulatory evaluation. The SAE Lightning Group did not submit any supporting financial data.
The FAA does not agree that the requirement to show that fuel tank
In addition, this rule allows both fault-tolerant and non-fault-tolerant design approaches. Under the rule, the fuel system must prevent catastrophic fuel vapor ignition due to lightning. To comply with this requirement, catastrophic fuel vapor ignition must be extremely improbable. If an applicant's design achieves this requirement through the use of fault-tolerant design, the safety analysis (§ 25.1309) to support the design will not have to be as extensive as one that would be necessary to support a non-fault-tolerant design. As a result, the rule allows industry the flexibility to select the means of compliance based on design approach, safety analysis, and costs. Therefore, the FAA determined that the regulatory evaluation did not need to be revised as a result of this comment.
The SAE Lightning Group, Bombardier, and Parker all commented on the discussion of fuel tank flammability reduction in the NPRM and asked for clarification of how flammability reduction could be used as a means of compliance with § 25.954.
Boeing stated that the majority of the NPRM discussion of fuel tank FRM was unnecessary because applicants could infer that the FAA would relax the requirement for providing fault tolerance if the FAA allowed FRM as a sole means of compliance. Boeing did not agree that the FAA should accept controlling fuel tank flammability as the primary means for preventing a fuel tank explosion without providing fault-tolerant lightning protection features.
As discussed in the previous section (4. Fault-Tolerant Design), the FAA does not agree that the lightning protection requirement in § 25.954 should dictate the use of fault-tolerant ignition protection features in the design without allowing the use of flammability control means. As explained in the NPRM, the intent of the amendment to § 25.954 is to require the design to take into account the likelihood of a critical lightning strike, the fuel tank being flammable, and the creation of an ignition source due to the failure of fuel system or structural lightning protection features. If designers develop a full-time fuel tank flammability control system that prevents the fuel tanks from being flammable during all foreseeable operating conditions and all phases of airplane operation (including descent), resulting in the probability of a fuel tank explosion being extremely improbable, this could achieve the level of safety that § 25.954 requires, and could be used as a means of compliance without the need for fault-tolerant lightning protection features. While fuel tank flammability control system technology has not evolved to a state where flammability control can replace the need for fault-tolerant ignition prevention, the FAA's goal is to develop rules that are performance-based, and in this case, to allow designers to comply via the use of flammability control when the technology is adequately developed. Allowing the use of fuel tank FRM for demonstrating compliance with the rule could offer designers the opportunity to reduce the number of fault-tolerant features and mandatory maintenance actions.
Section 25.954(d) [paragraph (c) in the NPRM] requires that the type design include CDCCLs identifying those design features that prevent catastrophic fuel vapor ignition caused by lightning and providing information to protect them. To ensure the continued effectiveness of those features, paragraph (d) also requires that the type design include inspections and test procedures, intervals between repetitive inspections and tests, and mandatory replacement times. This paragraph also requires applicants to place all this information in the ALS of the ICA.
The SAE Lightning Group proposed that CDCCLs be included as cautions
The FAA disagrees with the SAE Lightning Group's request to move the CDCCLs from the ALS of the ICA to the Cautions section of the maintenance manual. CDCCLs provide information that is essential for protecting the design features that are critical for preventing fuel tank explosions. The Caution section of the maintenance manual is not mandatory for U.S. operators, and therefore CDCCLs need to be included in the ALS of the ICA, which is mandatory.
The SAE Lightning Group commented that, since the Lightning ARC study and report in 2011, the use of Air Transport Association (ATA) Maintenance Steering Group (MSG)-3
Airbus and Airlines for America disagreed with the request to establish maintenance practices for both fault-tolerant and non-fault-tolerant protection features via the type certification process. Both commenters proposed that the FAA require airworthiness limitations and CDCCLs for only non-fault-tolerant design features. Both commenters stated that an airworthiness limitation requirement for fault-tolerant design features could be a disincentive to develop fault-tolerant designs and may increase the burden on operators unnecessarily. As an alternative, they proposed reliance on the current ATA MSG-3 process for establishing maintenance programs for
The FAA agrees with the SAE Lightning Group that all maintenance practices for both fault-tolerant and non-fault-tolerant protection features be established via the type certification process and not through the ATA MSG-3 process. Using the certification process will ensure that applicants develop necessary maintenance actions to maintain the integrity of lightning ignition source protection features. As all maintenance actions necessary to ensure the integrity of lightning ignition source protection features will be addressed by compliance with section H25.4(a)(5), the ICA requirement in the proposed section H25.X is not necessary and has been deleted from the final rule. This is discussed further in the discussion regarding appendix H.
The FAA disagrees with Airbus' and Airlines for America's proposal to rely on the ATA MSG-3 process for development of maintenance actions for fault-tolerant design features. U.S. operators are not required to adopt the ATA MSG-3 developed maintenance program, but they are required to include all airworthiness limitations in their maintenance program.
The SAE Lightning Group also stated that the reference to § 25.1729 in § 25.954(d) is not within the scope of this rule and requested that it be removed. The FAA agrees and removed that reference from the final rule.
Embraer suggested that § 25.954(d) include the same requirement that is in § 25.981(d). Section 25.981(d) requires the type design to include visible means for identifying critical features in areas where foreseeable maintenance actions, repairs, or alterations may compromise the CDCCLs. Embraer stated that this would harmonize both requirements.
The FAA does not agree. Because of the large number and multiple types of bonding features used for fuel tank and system lightning protection, it is not practical to require installation of visible means of identification for all lightning-related CDCCLs. However, all critical lightning protection features identified as CDCCLs must be included in the ALS of the ICA. Although the FAA made minor editorial changes
Section 25.981 requires that the airplane design protect the fuel tank and fuel tank system against ignition from all sources. This amendment adds an exception to § 25.981(a)(3) to remove lightning as an ignition source from the scope of this section and refers applicants to § 25.954 for lightning protection requirements.
Paragraph (d) of § 25.981 requires applicants to establish CDCCLs, inspections, or other procedures to ensure fuel tank safety. This amendment revises paragraph (d) to clarify that applicants must provide CDCCLs to identify critical design features, in addition to inspections or other procedures. The FAA received the following comments on the proposed changes to this section.
Boeing suggested that the FAA expand the applicability of § 25.981(d) to include the fuel tank system, in addition to the fuel tank, to be consistent with § 25.981(a). Paragraph (a) of § 25.981 requires ignition source prevention in the “fuel tank or fuel tank system.”
The FAA agrees and revised the final rule to add, “. . . or fuel tank system according to paragraph (a) of this section. . . .” This addition makes it consistent with § 25.981(a).
Boeing proposed that § 25.981(d) refer to paragraph (b) of that section in addition to the references to paragraphs (a) and (c) of that section because mandatory maintenance required by paragraph (d) should also apply to flammability reduction means.
The FAA agrees, and this amendment includes a reference to paragraph (b) in § 25.981(d).
Boeing requested that the FAA revise § 25.981(d) to delete the requirement for placement of visible means, limit that placement to areas where the means would be “practical and meaningful,” or provide more clear guidance. Boeing stated that, as proposed, the regulation provides no practical way to fully comply with the requirement to provide visible means of identifying CDCCL. Boeing argued that, “While it may be easy to pick the color of external fuel quantity wiring, much of the fuel tank design for ignition prevention is basic to airplane design, such as bonding, grounding, sealing, etc. There is no practical way to color code or otherwise identify these design features.”
The FAA partially agrees. The intent is not to require markings in all locations—only in those locations where foreseeable errors due to maintenance actions, repairs, or alterations may compromise critical features. This is not a new requirement with this amendment. However, this amendment deletes the example of visible means (color coding of wire to identify separation limitation), and it removes the requirement of identifying visible means as CDCCLs, both of which had been added at amendment 25-125. AC 25.981-1D provides additional guidance.
With some differences from what the FAA proposed in the NPRM, this amendment adds a new paragraph, (a)(5), to section H25.4 of appendix H to part 25. This paragraph requires any mandatory replacement times, inspection intervals, related inspection and test procedures, and CDCCLs for lightning protection features approved under § 25.954 to be included in the ALS of the ICA.
The SAE Lightning Group proposed revisions to the airworthiness limitation requirements of section H25.4(a)(5) by adding the phrases “critical design configuration control limitations” and “fault tolerant and non-fault tolerant.” The commenter stated that the revisions would align this paragraph with the SAE Lightning Group's requested changes to § 25.954 regarding fault-tolerant and non-fault tolerant designs. The commenter also requested deletion of the proposed section H25.X, stating that the MSG-3 process has been shown to be ineffective for maintenance inspections and procedures that are critical to fuel tank systems lightning protection.
Although Airbus was a participant in the SAE Lightning Group, it disagreed with the above comments on section H25.4(a)(5) because it makes reference to the ALS as being the only means to develop the ICA for both fault-tolerant and non-fault tolerant lightning protection features. Airbus suggested instead that the FAA limit the applicability of section H25.4(a)(5) to non-fault-tolerant lightning protection features rather than to all lightning protection features. Airbus also asked that the FAA delete the reference to sampling programs in section H25.X. Airbus stated that sampling programs are typically managed by the type certificate applicant, not the operator of the airplane that uses the ICA to develop their maintenance programs.
The FAA partially agrees with the SAE Lightning Group's proposed changes. The FAA does not agree to the proposed changes to section H25.4(a)(5) as the FAA did not adopt the SAE Lightning Group's requested changes to § 25.954, with the exception of deleting reference to § 25.1729. However, the FAA did add the term “critical design configuration control limitations” to the final section H25.4(a)(5). Thus, section H25.4(a)(5) now states, “Each mandatory replacement time, inspection interval, and related inspection and test procedure, and each critical design configuration control limitation for each lightning protection feature approved under § 25.954.”
The FAA agrees with the request to delete the proposed new section H25.X because all necessary maintenance actions for ensuring the integrity of lightning ignition source protection features will be addressed by compliance with section H25.4(a)(5). Therefore, the ICA requirement in the proposed section H25.X is not necessary, so that section is not included in the final rule. This also addresses Airbus's request to delete the reference to sampling programs in section H25.X. The FAA disagrees with Airbus's request to add the phrase “non-fault-tolerant” to section H25.4(a)(5) because all necessary maintenance actions, both fault-tolerant and non-fault-tolerant, must be included in the ALS as required by section H25.4(a)(5).
An individual suggested that the FAA revise §§ 25.954 and 25.981 to include a requirement for fuel system design features to mitigate the hazards of electrostatic charge. The commenter stated that these design features would also have a role in lightning protection.
Section 25.899 specifically addresses electrostatic charge, and § 25.981 addresses all ignition sources, which would include electrostatic charge. Lightning is the only exception, and it is now addressed by § 25.954. Adding a specific requirement for electrostatic charge to §§ 25.954 and 25.981 would be redundant and may cause confusion. Therefore, the FAA did not revise the rules because of this comment.
Boeing requested that the FAA explain the assumption made in paragraph IV.A.3 of the NPRM preamble, “Regulatory Notices and Analyses, Regulatory Evaluation, Assumptions and Data Sources,” that computational weights of composite wing airplanes would change from current approximate 15%-25% level linearly increasing to 50% level for a ten-year production cycle.
The FAA clarified the information with the major manufacturer that had provided the data during the development of the NPRM regulatory evaluation. The assumption is more correctly stated that the weighted production rate of composite wing airplanes is estimated at 15%-25% of total production at the beginning of the 10-year production cycle, increasing linearly to 50% at the end of the cycle.
Changes to Federal regulations must undergo several economic analyses. First, Executive Order 12866 and Executive Order 13563 direct that each Federal agency shall propose or adopt a regulation only upon a reasoned determination that the benefits of the intended regulation justify its costs. Second, the Regulatory Flexibility Act of 1980 (Pub. L. 96-354) requires agencies to analyze the economic impact of regulatory changes on small entities. Third, the Trade Agreements Act (Pub. L. 96-39) prohibits agencies from setting standards that create unnecessary obstacles to the foreign commerce of the United States. In developing U.S. standards, this Trade Act requires agencies to consider international standards and, where appropriate, that they be the basis of U.S. standards. Fourth, the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4) requires agencies to prepare a written assessment of the costs, benefits, and other effects of final rules that include a Federal mandate likely to result in the expenditure by State, local, or tribal governments, in the aggregate, or by the private sector, of $100 million or more annually (adjusted for inflation with base year of 1995). This portion of the preamble summarizes the FAA's analysis of the economic impacts of this final rule. We suggest readers seeking greater detail read the full regulatory evaluation, a copy of which we have placed in the docket for this rulemaking.
In conducting these analyses, FAA has determined that this final rule: (1) Has benefits that justify its costs; (2) is not an economically “significant regulatory action” as defined in section 3(f) of Executive Order 12866; (3) is not “significant” as defined in DOT's Regulatory Policies and Procedures; (4) will not have a significant economic impact on a substantial number of small entities; (5) will not create unnecessary obstacles to the foreign commerce of the United States; and (6) will not impose an unfunded mandate on state, local, or tribal governments, or on the private sector by exceeding the threshold identified above. These analyses are summarized below.
This final rule will be relieving for both government and industries with the estimated net benefits. The FAA assesses cost savings based on resources saved for reducing regulatory burden on both industry and the FAA. This rule results in cost savings by reducing the number of exemptions and special conditions.
Over a 10-year period, the average total present value savings to manufacturers and the FAA are about $29.03 million at a 7% discount rate with annualized savings of about $4.13 million. The lower and the higher estimates of the total present value savings are $16.17 million and $41.93 million at a 7% discount rate, with annualized savings of $2.30 million and $5.97 million, respectively. The final rule will maintain achieved safety levels related to fuel tank structure and system lightning protection commensurate with the current requirements.
• Part 25 airplane manufacturers.
• Operators of part 25 airplanes.
• The Federal Aviation Administration.
• Data related to industry savings mainly come from airplane manufacturers.
• Data related to requests for exemptions and special conditions come from FAA internal data sources and the judgments of agency subject matter experts.
• The FAA would process 4 special conditions and 7 exemptions in the next 10 years in the absence of this rule.
• Domestic airplane manufacturers would petition for two special conditions and three exemptions before reaching their cost-benefit steady-state.
• While foreign manufacturers may benefit also from this final rule, cost savings directly attributable to foreign entities are not included in this analysis.
• For the final rule, the FAA estimates cost savings from avoided petitions for exemption and special conditions occur at the beginning of a 10-year production cycle.
• Projected impacts on manufacturers and the government are for a 10-year period associated with one production cycle.
• All monetary values are expressed in 2016 dollars.
The Regulatory Flexibility Act of 1980 (Pub. L. 96-354) (RFA) establishes “as a principle of regulatory issuance that agencies shall endeavor, consistent with the objectives of the rule and of applicable statutes, to fit regulatory and informational requirements to the scale of the businesses, organizations, and governmental jurisdictions subject to regulation.” To achieve this principle, agencies are required to solicit and consider flexible regulatory proposals and to explain the rationale for their actions to assure that such proposals are given serious consideration.” The RFA covers a wide-range of small entities, including small businesses, not-for-profit organizations, and small governmental jurisdictions.
Agencies must perform a review to determine whether a rule will have a significant economic impact on a substantial number of small entities. If the agency determines that it will, the agency must prepare a regulatory flexibility analysis as described in the RFA.
However, if an agency determines that a rule is not expected to have a significant economic impact on a substantial number of small entities, section 605(b) of the RFA provides that the head of the agency may so certify and a regulatory flexibility analysis is not required. The certification must include a statement providing the factual basis for this determination, and the reasoning should be clear.
This final rule amends certain airworthiness regulations that were not always practical for transport category airplanes regarding lightning protection of fuel tanks and systems. This final rule provides burden relief and savings to airplane manufacturers, who are large entities. Therefore, as provided in section 605(b), the head of the FAA certifies that this final rule will not have a significant economic impact on a substantial number of small entities and also certifies that a regulatory flexibility analysis is not required. The FAA solicited comments in the NPRM and did not receive comments with regard to this certification. Therefore, the FAA Administrator certifies that this rule does not have a significant economic impact on a substantial number of small entities.
The Trade Agreements Act of 1979 (Pub. L. 96-39), as amended by the Uruguay Round Agreements Act (Pub. L. 103-465), prohibits Federal agencies from establishing standards or engaging in related activities that create unnecessary obstacles to the foreign commerce of the United States. Pursuant to these Acts, the establishment of standards is not considered an unnecessary obstacle to the foreign commerce of the United States, so long as the standard has a legitimate domestic objective, such as the protection of safety, and does not operate in a manner that excludes imports that meet this objective. The statute also requires consideration of international standards and, where appropriate, that they be the basis for U.S. standards. The FAA has assessed the potential effect of this final rule and determined that it could result in the same benefits to domestic and international entities in accord with the Trade Agreements Act.
Title II of the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4) 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 an expenditure of $100 million or more (in 1995 dollars) in any one year by State, local, and tribal governments, in the aggregate, or by the private sector; such a mandate is deemed to be a “significant regulatory action.” The FAA currently uses an inflation-adjusted value of $155 million in lieu of $100 million. This final rule does not contain such a mandate; therefore, the requirements of Title II of the Act do not apply.
The Paperwork Reduction Act of 1995 (44 U.S.C. 3507(d)) requires that the FAA consider the impact of paperwork and other information collection burdens imposed on the public. The FAA has determined that there is no new requirement for information collection associated with this final rule.
In keeping with U.S. obligations under the Convention on International Civil Aviation, it is FAA policy to conform to International Civil Aviation Organization (ICAO) Standards and Recommended Practices to the maximum extent practicable. The FAA has determined that there are no ICAO Standards and Recommended Practices that correspond to these regulations.
FAA Order 1050.1F identifies FAA actions that are categorically excluded from preparation of an environmental assessment or environmental impact statement under the National Environmental Policy Act in the absence of extraordinary circumstances. The FAA has determined this rulemaking action qualifies for the categorical exclusion identified in paragraph 5-6.6 and involves no extraordinary circumstances.
The FAA has analyzed this final rule under the principles and criteria of Executive Order 13132, Federalism. The agency determined that this action will not have a substantial direct effect on the States, or the relationship between the Federal Government and the States, or on the distribution of power and responsibilities among the various levels of government, and, therefore, does not have Federalism implications.
The FAA analyzed this final rule under Executive Order 13211, Actions Concerning Regulations that Significantly Affect Energy Supply, Distribution, or Use (May 18, 2001). The agency has determined that it is not a “significant energy action” under the executive order and it is not likely to have a significant adverse effect on the supply, distribution, or use of energy.
Executive Order 13609, Promoting International Regulatory Cooperation, promotes international regulatory cooperation to meet shared challenges involving health, safety, labor, security, environmental, and other issues and to reduce, eliminate, or prevent unnecessary differences in regulatory requirements. The FAA has analyzed this action under the policies and agency responsibilities of Executive Order 13609, and has determined that this action would have no effect on international regulatory cooperation.
This final rule is considered an E.O. 13771 deregulatory action. Details on the estimated cost savings of this rule can be found in the rule's economic analysis.
An electronic copy of a rulemaking document may be obtained from the internet by—
1. Searching the Federal eRulemaking Portal (
2. Visiting the FAA's Regulations and Policies web page at
3. Accessing the Government Printing Office's web page at
Copies may also be obtained by sending a request (identified by notice, amendment, or docket number of this rulemaking) to the Federal Aviation Administration, Office of Rulemaking, ARM-1, 800 Independence Avenue SW, Washington, DC 20591, or by calling (202) 267-9680.
Comments received may be viewed by going to
The Small Business Regulatory Enforcement Fairness Act (SBREFA) of 1996 requires FAA to comply with small entity requests for information or advice about compliance with statutes and regulations within its jurisdiction. A small entity with questions regarding this document, may contact its local FAA official, or the person listed under the
Aircraft, Aviation safety, Reporting and recordkeeping requirements.
In consideration of the foregoing, the Federal Aviation Administration amends chapter I of title 14, Code of Federal Regulations as follows:
49 U.S.C. 106(f), 106(g), 40113, 44701, 44702 and 44704.
(a) For purposes of this section—
(1) A critical lightning strike is a lightning strike that attaches to the airplane in a location that, when combined with the failure of any design feature or structure, could create an ignition source.
(2) A fuel system includes any component within either the fuel tank structure or the fuel tank systems, and any airplane structure or system components that penetrate, connect to, or are located within a fuel tank.
(b) The design and installation of a fuel system must prevent catastrophic fuel vapor ignition due to lightning and its effects, including:
(1) Direct lightning strikes to areas having a high probability of stroke attachment;
(2) Swept lightning strokes to areas where swept strokes are highly probable; and
(3) Lightning-induced or conducted electrical transients.
(c) To comply with paragraph (b) of this section, catastrophic fuel vapor ignition must be extremely improbable, taking into account flammability, critical lightning strikes, and failures within the fuel system.
(d) To protect design features that prevent catastrophic fuel vapor ignition caused by lightning, the type design must include critical design configuration control limitations (CDCCLs) identifying those features and providing information to protect them. To ensure the continued effectiveness of those design features, the type design must also include inspection and test procedures, intervals between repetitive inspections and tests, and mandatory replacement times for those design features used in demonstrating compliance to paragraph (b) of this section. The applicant must include the information required by this paragraph in the Airworthiness Limitations section of the Instructions for Continued Airworthiness required by § 25.1529.
(a) * * *
(3) Except for ignition sources due to lightning addressed by § 25.954, demonstrating that an ignition source could not result from each single failure, from each single failure in combination with each latent failure condition not shown to be extremely remote, and from all combinations of failures not shown to be extremely improbable, taking into account the effects of manufacturing variability, aging, wear, corrosion, and likely damage.
(d) To protect design features that prevent catastrophic ignition sources within the fuel tank or fuel tank system according to paragraph (a) of this section, and to prevent increasing the flammability exposure of the tanks above that permitted in paragraph (b) of this section, the type design must include critical design configuration control limitations (CDCCLs) identifying those features and providing instructions on how to protect them. To ensure the continued effectiveness of those features, and prevent degradation of the performance and reliability of any means provided according to paragraphs (a), (b), or (c) of this section, the type design must also include necessary inspection and test procedures, intervals between repetitive inspections and tests, and mandatory replacement times for those features. The applicant must include information required by this paragraph in the Airworthiness Limitations section of the Instructions for Continued Airworthiness required by § 25.1529. The type design must also include visible means of identifying critical features of the design in areas of the airplane where foreseeable maintenance actions, repairs, or alterations may compromise the CDCCLs.
(a) * * *
(5) Each mandatory replacement time, inspection interval, and related inspection and test procedure, and each critical design configuration control limitation for each lightning protection feature approved under § 25.954.
Food and Drug Administration, HHS.
Final rule.
The Food and Drug Administration (FDA or we) is amending the food additive regulation for vitamin D
This rule is effective September 20, 2018. Submit either electronic or written objections and requests for a hearing on the final rule by October 22, 2018. The Director of the Federal Register approves the incorporation by reference of certain publications listed in the rule as of September 20, 2018. See the
You may submit objections and requests for a hearing as follows. Please note that late, untimely filed objections will not be considered. Electronic objections must be submitted on or before October 22, 2018. The
Submit electronic objections in the following way:
•
• If you want to submit an objection with confidential information that you do not wish to be made available to the public, submit the objection 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 objections submitted to the Dockets Management Staff, FDA will post your objection, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in “Instructions.”
• Confidential Submissions—To submit an objection with confidential information that you do not wish to be made publicly available, submit your objections 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
Judith Kidwell, Center for Food Safety and Applied Nutrition (HFS-265), Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740-3835, 240-402-1071.
In the
Section 409(i) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 348(i)) states that we shall, by regulation, establish the procedure for amending or repealing a food additive regulation, and that this procedure shall conform to the procedure provided in section 409 of the FD&C Act. Our regulations specific to administrative actions for food additives provide that the Commissioner of Food and Drugs, on his own initiative or on the petition of any interested person, may propose the issuance of a regulation amending or repealing a regulation pertaining to a food additive (§ 171.130(a) (21 CFR 171.130(a))). The regulations further provide that any such petition must include an assertion of facts, supported by data, showing that new information exists with respect to the food additive or that new uses have been developed or old uses abandoned, that new data are available as to toxicity of the chemical, or that experience with the existing regulation or exemption may justify its amendment or repeal. New data submitted as a food additive petition must be furnished in the form specified in 21 CFR 171.1 and 171.100 for submitting such petitions (§ 171.130(b)).
In the
The Juice Products Association stated that the proposed revision of § 172.380 to specify absolute values of calcium on a mg/mL basis rather than a percentage of RDI is needed to maintain the relative parity between fortified 100 percent fruit juices and fruit juice drinks and many dairy products. Without this change, the petitioner stated that 100 percent fruit juices with vitamin D
Because the petitioner sought to revise the existing regulation to restore the amount of calcium fortification required to levels on par with milk, without introducing new uses for vitamin D
Additionally, the current regulation for the use of vitamin D
FDA is incorporating by reference the monograph from Food Chemicals Codex, 11th ed., 2018, pp. 1243-1244 (vitamin D
The FCC monograph establishes the standard for purity and identity for vitamin D
Based on data and information in the petition, we conclude that amending the food additive regulations in the regulation for vitamin D
Additionally, the current regulation for the use of vitamin D
In accordance with § 171.1(h) (21 CFR 171.1(h)), the petition and the documents that we considered and relied upon in reaching our decision to approve the petition will be made available for public disclosure (see
We previously considered the environmental effects of this rule, as stated in the July 26, 2017,
This final rule contains no collection of information. Therefore, clearance by the Office of Management and Budget under the Paperwork Reduction Act of 1995 is not required.
Our review of this petition was limited to section 409 of the FD&C Act. This final rule is not a statement regarding compliance with other sections of the FD&C Act. For example, section 301(ll) of the FD&C Act (21 U.S.C. 331(ll)) prohibits the introduction or delivery for introduction into interstate commerce of any food that contains a drug approved under section 505 of the FD&C Act (21 U.S.C. 355), a biological product licensed under section 351 of the Public Health Service Act (42 U.S.C. 262), or a drug or biological product for which substantial clinical investigations have been instituted and their existence has been made public, unless one of the exemptions in section 301(ll)(1) to (4) of the FD&C Act applies. In our review of this petition, we did not consider whether section 301(ll) of the FD&C Act or any of its exemptions apply to food containing this additive. Accordingly, this final rule should not be construed to be a statement that a food containing this additive, if introduced or delivered for introduction into interstate commerce, would not violate section 301(ll) of the FD&C Act. Furthermore, this language is included in all food additive final rules and therefore should not be construed to be a statement of the likelihood that section 301(ll) of the FD&C Act applies.
If you will be adversely affected by one or more provisions of this regulation, you may file with the Dockets Management Staff (see
Any objections received in response to the regulation may be seen in the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through Friday, and will be posted to the docket at
Food additives, Incorporation by reference, Reporting and recordkeeping requirements.
Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs, 21 CFR part 172 is amended as follows:
21 U.S.C. 321, 341, 342, 348, 371, 379e.
(b) Vitamin D
(c) * * *
(1) At levels not to exceed 100 International Units (IU) per 240 milliliters (mL) in 100 percent fruit juices (as defined under § 170.3(n)(35) of this chapter) that are fortified with greater than or equal to 330 milligrams (mg) of calcium per 240 mL, excluding fruit juices that are specially formulated or processed for infants.
(2) At levels not to exceed 100 IU per 240 mL in fruit juice drinks (as defined under § 170.3(n)(35) of this chapter) that
Coast Guard, DHS.
Final rule.
The Coast Guard is modifying the operating schedule that governs the operation of the Flagler Memorial (SR A1A) Bridge, mile 1021.8, the Royal Park (SR 704) Bridge, mile 1022.6, and the Southern Boulevard (SR 700/80) Bridge, mile 1024.7, across the Atlantic Intracoastal Waterway, at West Palm Beach, Florida. This modification allows the Flagler Memorial, Royal Park and Southern Boulevard Bridges to operate on alternative schedules when the President of the United States, members of the First Family, or other persons under the protection of the Secret Service visit Mar-a-Lago. The modifications are necessary to accommodate the increase in vehicular traffic when the presidential motorcade is in transit.
This rule is effective on September 20, 2018.
To view documents mentioned in this preamble as being available in the docket, go to
If you have questions on this rule, call or email CWO4 Robert Wooten, Coast Guard Sector Miami, FL, Waterways Management Division, telephone 305-535-4311, email
On August 17, 2017, the Coast Guard published a notice of deviation from drawbridge regulation with request for comments in the
We are issuing rule under 5 U.S.C. 553(d)(3), the Coast Guard finds that good cause exists for making this rule effective in less than 30 days after publication in the
The Coast Guard is issuing this rule under authority 33 U.S.C. 499. The Flagler Memorial (SR A1A) Bridge, mile 1021.8, across the AICW (Lake Worth Lagoon) at West Palm Beach, Florida is a double-leaf bascule bridge that has a vertical clearance of 22 feet at mean high water in the closed position. The Royal Park (SR 704) Bridge, mile 1022.6, across the AICW (Lake Worth Lagoon) at West Palm Beach, Florida is a double-leaf bascule bridge that has a vertical clearance of 21 feet at mean high water in the closed position. The Southern Boulevard (SR 700/80) Bridge, mile 1024.7, across the AICW (Lake Worth Lagoon) at West Palm Beach, Florida is under construction, a temporary lift bridge is in place that has a vertical clearance of 14 feet at mean high water in the closed position and a 65 foot vertical clearance in the open position. The existing regulations are published in 33 CFR 117.261(u), Flagler Memorial Bridge, § 117.261(v) Royal Park Bridge, and § 117.261(w) Southern Boulevard Bridge.
The bridge owner, Florida Department of Transportation, requested changes to the drawbridge operating schedules to better facilitate orderly vehicle traffic flow across the Flagler Memorial, Royal Park and Southern Boulevard bridges when the President of the United States, members of the First Family, or other persons under the protection of the Secret Service visit Mar-a-Lago. The increase in traffic congestion occurs when the Presidential Security Zone (82 FR 17295) is enforced which closes the Southern Boulevard Bridge when the presidential motorcade is in transit. This action requires through traffic to use the Flagler Memorial and Royal Park Bridges.
As noted above, we received four comments total on the two notices of deviation published on August 17, 2017 and March 6, 2018, respectively. Of the four comments received, one was a political statement with no relevance on the proposed regulation. Three of the four comments received were in favor of the regulation. Two of the comments in favor of the regulation suggested the changes be made permanent regardless of presidential visits. The Coast Guard has considered this recommendation, however, making the modified operating schedule permanent would place an unreasonable burden on navigation and potentially have a negative impact on safe navigation. The modified schedule is only in effect when uninterrupted transit of dignitaries are crossing the Southern Boulevard Bridge. While vessels may have to wait up to an hour, it is only during the weekdays and for a short period.
We developed this rule after considering numerous statutes and Executive Orders related to rulemaking. Below we summarize our analyses based on a number of these statutes and
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. Executive Order 13771 directs agencies to control regulatory costs through a budgeting process. This rule has not been designated a “significant regulatory action,” under Executive Order 12866. Accordingly, it has not been reviewed by the Office of Management and Budget (OMB) and pursuant to OMB guidance it is exempt from the requirements of Executive Order 13771.
This regulatory action determination is based on the ability that vessels able to pass through the Flagler Memorial and Royal Park Bridges in the closed position may do so at any time. The bridges will be able to open for emergencies. The Southern Boulevard Bridge will be under the control of the on-scene designated representative when the Presidential Security Zone is enforced.
The Regulatory Flexibility Act of 1980 (RFA), 5 U.S.C. 601-612, as amended, requires federal agencies to consider the potential impact of regulations on small entities during rulemaking. The term “small entities” comprises small businesses, not-for-profit organizations that are independently owned and operated and are not dominant in their fields, and governmental jurisdictions with populations of less than 50,000. The Coast Guard received zero comments from the Small Business Administration on this rule. The Coast Guard certifies under 5 U.S.C. 605(b) that this rule will not have a significant economic impact on a substantial number of small entities.
While some owners or operators of vessels intending to transit the bridge may be small entities, for the reasons stated in section V.A above, this rule will not have a significant economic impact on any vessel owner or operator.
Under section 213(a) of the Small Business Regulatory Enforcement Fairness Act of 1996 (Pub. L. 104-121), we want to assist small entities in understanding this rule. If the rule would affect your small business, organization, or governmental jurisdiction and you have questions concerning its provisions or options for compliance, please contact the person listed in the
Small businesses may send comments on the actions of Federal employees who enforce, or otherwise determine compliance with, Federal regulations to the Small Business and Agriculture Regulatory Enforcement Ombudsman and the Regional Small Business Regulatory Fairness Boards. The Ombudsman evaluates these actions annually and rates each agency's responsiveness to small business. If you wish to comment on actions by employees of the Coast Guard, call 1-888-REG-FAIR (1-888-734-3247). The Coast Guard will not retaliate against small entities that question or complain about this rule or any policy or action of the Coast Guard.
This rule calls for no new collection of information under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).
A rule has implications for federalism under Executive Order 13132, Federalism, if it has 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. We have analyzed this rule under that Order and have determined that it is consistent with the fundamental federalism principles and preemption requirements described in Executive Order 13132.
Also, this rule does not have tribal implications under Executive Order 13175, Consultation and Coordination with Indian Tribal Governments, because it does not have a substantial direct effect 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.
The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538) requires Federal agencies to assess the effects of their discretionary regulatory actions. In particular, the Act addresses actions that may result in the expenditure by a State, local, or tribal government, in the aggregate, or by the private sector of $100,000,000 (adjusted for inflation) or more in any one year. Though this rule will not result in such an expenditure, we do discuss the effects of this rule elsewhere in this preamble.
We have analyzed this rule under Department of Homeland Security Management Directive 023-01 and Commandant Instruction M16475.lD, which guides the Coast Guard in complying with the National Environmental Policy Act of 1969 (NEPA) (42 U.S.C. 4321-4370f), and have made a determination that this action is one of a category of actions which do not individually or cumulatively have a significant effect on the human environment. This rule simply promulgates the operating regulations or procedures for drawbridges. This action is categorically excluded from further review, under figure 2-1, paragraph (32)(e), of the Instruction.
A Record of Environmental Consideration and a Memorandum for the Record are not required for this rule.
The Coast Guard respects the First Amendment rights of protesters. Protesters are asked to contact the person listed in the
Bridges.
For the reasons discussed in the preamble, the Coast Guard amends 33 CFR part 117 as follows:
33 U.S.C. 499; 33 CFR 1.05-1; Department of Homeland Security Delegation No. 0170.1.
(u)
(2) When the security zone is enforced, the draw is allowed to remain closed to navigation from 2:15 p.m. to 5:30 p.m. with the exception of a once an hour opening at 2:15 p.m., 3:15 p.m., 4:15 p.m. and 5:15 p.m., weekdays only, if vessels are requesting an opening. At all other times the draw shall open on the quarter and three-quarter hour.
(v)
(2) When the security zone is enforced, the draw is allowed to remain closed to navigation from 2:15 p.m. to 5:30 p.m. with the exception of a once an hour opening at 2:30 p.m., 3:30 p.m., 4:30 p.m. and 5:30 p.m., weekdays only, if vessels are requesting an opening. At all other times the draw shall open on the hour and half-hour.
(w)
(2) When the security zone is enforced, the draw may be closed without advance notice to permit uninterrupted transit of dignitaries across the bridge. At all other times the bridge shall open on the quarter and three-quarter hour, or as directed by the on-scene designated representative.
Coast Guard, DHS.
Temporary final rule.
The Coast Guard is establishing a temporary safety zone for navigable waters within a 280-foot radius of the launch site located at 104 Bayshore Rd., Oswego, NY. This safety zone is intended to restrict vessels form portions of Lake Ontario during the C&S Worldwide Holdings Inc. fireworks display. This temporary safety zone is necessary to protect mariners and vessels from the navigational hazards associated with a fireworks display. Entry of vessels or persons into this zone is prohibited unless specifically authorized by the Captain of the Port Buffalo.
This rule is effective from 7:30 p.m. until 8:30 p.m. on September 21, 2018.
To view documents mentioned in this preamble as being available in the docket, go to
If you have questions on this rule, call or email LTJG Sean Dolan, Chief Waterways Management Division, U.S. Coast Guard; telephone 716-843-9322, email
The Coast Guard is issuing this temporary rule without prior notice and opportunity to comment pursuant to authority under section 4(a) of the Administrative Procedure Act (APA) (5 U.S.C. 553(b)). This provision authorizes an agency to issue a rule without prior notice and opportunity to comment when the agency for good cause finds that those procedures are “impracticable, unnecessary, or contrary to the public interest.” Under 5 U.S.C. 553 (b)(B), the Coast Guard finds that good cause exists for not publishing a notice of proposed rulemaking (NPRM) with respect to this rule because the event sponsor did not submit notice to the Coast Guard with sufficient time remaining before the event to publish an NPRM. Delaying the effective date would be contrary to the rule's objectives of enhancing safety of life on the navigable water and protection of persons and vessels in vicinity of the fireworks display.
Under 5 U.S.C. 553(d)(3), the Coast Guard finds that good cause exists for making this rule effective less than 30 days after publication in the
The Coast Guard is issuing this rule under authority in 33 U.S.C 1231. The Captain of the Port Buffalo (COTP) has determined that a fireworks display presents significant risks to the public safety and property. Such hazards include premature and accidental detonations, dangerous projectiles, and falling or burning debris. This rule is needed to protect personnel, vessels, and the marine environment in the navigable waters within the safety zone while the fireworks display takes place.
This rule establishes a temporary safety zone on September 21, 2018, from 7:30 p.m. until 8:30 p.m. The safety zone will encompass all waters of Lake Ontario, Oswego, NY contained within a 280-foot radius of: 43°30′43.30″ N, 76°26′2.70″ W.
Entry into, transiting, or anchoring within the safety zone is prohibited unless authorized by the Captain of the Port Buffalo or his designated on-scene representative. The Captain of the Port or his designated on-scene representative may be contacted via VHF Channel 16.
We developed this rule after considering numerous statutes and Executive orders related to rulemaking. Below we summarize our analyses based on a number of these statutes and Executive orders, and we discuss First Amendment rights of protestors.
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. Executive Order 13771 directs agencies to control regulatory costs through a budgeting process. This rule has not been designated a “significant regulatory action,” under Executive Order 12866. Accordingly, this rule has not been reviewed by the Office of Management and Budget (OMB), and pursuant to OMB guidance it is exempt from the requirements of Executive Order 13771.
This regulatory action determination is based on the conclusion that this rule is not a significant regulatory action. We anticipate that it will have minimal impact on the economy, will not interfere with other agencies, will not adversely alter the budget of any grant or loan recipients, and will not raise any novel legal or policy issues. The safety zone created by this rule will be relatively small and enforced for a relatively short time. Also, the safety zone has been designed to allow vessels
The Regulatory Flexibility Act of 1980, 5 U.S.C. 601-612, as amended, requires Federal agencies to consider the potential impact of regulations on small entities during rulemaking. The term “small entities” comprises small businesses, not-for-profit organizations that are independently owned and operated and are not dominant in their fields, and governmental jurisdictions with populations of less than 50,000. The Coast Guard certifies under 5 U.S.C. 605(b) that this rule will not have a significant economic impact on a substantial number of small entities.
While some owners or operators of vessels intending to transit the safety zone may be small entities, for the reasons stated in section V.A above, this rule will not have a significant economic impact on any vessel owner or operator.
Under section 213(a) of the Small Business Regulatory Enforcement Fairness Act of 1996 (Pub. L. 104-121), we want to assist small entities in understanding this rule. If the rule would affect your small business, organization, or governmental jurisdiction and you have questions concerning its provisions or options for compliance, please contact the person listed in the
Small businesses may send comments on the actions of Federal employees who enforce, or otherwise determine compliance with, Federal regulations to the Small Business and Agriculture Regulatory Enforcement Ombudsman and the Regional Small Business Regulatory Fairness Boards. The Ombudsman evaluates these actions annually and rates each agency's responsiveness to small business. If you wish to comment on actions by employees of the Coast Guard, call 1-888-REG-FAIR (1-888-734-3247). The Coast Guard will not retaliate against small entities that question or complain about this rule or any policy or action of the Coast Guard.
This rule will not call for a new collection of information under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).
A rule has implications for federalism under Executive Order 13132, Federalism, if it has 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. We have analyzed this rule under that Order and have determined that it is consistent with the fundamental federalism principles and preemption requirements described in Executive Order 13132.
Also, this rule does not have tribal implications under Executive Order 13175, Consultation and Coordination with Indian Tribal Governments, because it does not have a substantial direct effect 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. If you believe this rule has implications for federalism or Indian tribes, please contact the person listed in the
The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538) requires Federal agencies to assess the effects of their discretionary regulatory actions. In particular, the Act addresses actions that may result in the expenditure by a State, local, or tribal government, in the aggregate, or by the private sector of $100,000,000 (adjusted for inflation) or more in any one year. Though this rule will not result in such an expenditure, we do discuss the effects of this rule elsewhere in this preamble.
We have analyzed this rule under Department of Homeland Security Directive 023-01 and Commandant Instruction M16475.1D, which guide the Coast Guard in complying with the National Environmental Policy Act of 1969 (42 U.S.C. 4321-4370f), and have determined that this action is one of a category of actions that do not individually or cumulatively have a significant effect on the human environment. This rule establishes a temporary safety zone. It is categorically excluded from further review under paragraph L60(a) of Appendix A, Table 1 of DHS Instruction Manual 023-01-001-01, Rev. 01. A Record of Environmental Consideration supporting this determination is available in the docket where indicated under
The Coast Guard respects the First Amendment rights of protesters. Protesters are asked to contact the person listed in the
Harbors, Marine safety, Navigation (water), Reporting and recordkeeping requirements, Security measures, Waterways.
For the reasons discussed in the preamble, the Coast Guard amends 33 CFR part 165 as follows:
33 U.S.C. 1231; 50 U.S.C. 191; 33 CFR 1.05-1, 6.04-1, 6.04-6, and 160.5; Department of Homeland Security Delegation No. 0170.1.
(a)
(b)
(c)
(2) This safety zone is closed to all vessel traffic, except as may be permitted by the Captain of the Port Buffalo or his designated on-scene representative.
(3) The “on-scene representative” of the Captain of the Port Buffalo is any Coast Guard commissioned, warrant or petty officer who has been designated by the Captain of the Port Buffalo to act on his behalf.
(4) Vessel operators desiring to enter or operate within the safety zone must contact the Captain of the Port Buffalo or his on-scene representative to obtain
Environmental Protection Agency (EPA).
Final rule.
The Environmental Protection Agency (EPA) is approving eight State Implementation Plan (SIP) revisions submitted by the State of Wyoming; four submitted on March 27, 2017, and four submitted on March 28, 2018. The revisions include updates to incorporation by reference within several parts of the Wyoming Air Quality Standards and Regulations that are part of the SIP. Additional revisions are being approved that: Correct an inconsistency regarding internal combustion engine nitrogen oxide requirements; amend three state regulations to maintain consistency with federal regulations; and update a state internet address.
This final rule is effective on October 22, 2018.
The EPA has established a docket for this action under Docket ID No. EPA-R08-OAR-2018-0389. All documents in the docket are listed on the
Chris Dresser, Air Program, U.S. Environmental Protection Agency (EPA), Region 8, Mail Code 8P-AR, 1595 Wynkoop Street, Denver, Colorado 80202-1129, (303) 312-6385,
In a rulemaking published on July 23, 2018 (83 FR 34811), the EPA proposed approval of eight revisions to the Wyoming Air Quality Standards and Regulations submitted by the State of Wyoming; four submitted on March 27, 2017, and four submitted on March 28, 2018. The revisions include updates to incorporation by reference within several parts of the Wyoming Air Quality Standards and Regulations that are part of the SIP. Additional revisions were proposed that: (1) Correct an inconsistency regarding internal combustion engine nitrogen oxide requirements; (2) amend three state regulations to maintain consistency with federal regulations; and (3) update a state internet address. In this rulemaking the EPA is taking final action to approve the proposed revisions. The reasons for our approval are provided in the proposed rule.
The EPA received three anonymous comments on the proposed SIP amendments to the Wyoming Air Quality Standards and Regulations. After reviewing the comments, the EPA has determined that the comments are outside the scope of our proposed action or fail to identify any material issue necessitating a response. All comments received on this action are available for review in the docket for this rulemaking. This rule will be finalized as proposed without revisions.
For the reasons expressed in the proposed rule, the EPA is approving the eight SIP submittals to the Wyoming Air Quality Standards and Regulations submitted by the State of Wyoming on March 27, 2017, and March 28, 2018. This action updates: (1) Chapter 8 Non-attainment Area Regulations, Section 10, Incorporation by reference (2017 Submittal); (2) Chapter 8, Non-attainment Area Regulations, Section 3, Conformity of general federal actions to state implementation plans (2018 Submittal), and Section 10, Incorporation by reference (2018 Submittal); (3) Chapter 6, Permitting Requirements, Section 4, Prevention of significant deterioration, to remove an outdated
In this rule, the EPA is finalizing regulatory text that includes incorporation by reference. In accordance with requirements of 1 CFR 51.5, the EPA is finalizing the incorporation by reference of Wyoming Air Quality Standards and Regulations described in the amendments set forth to 40 CFR part 52, below. The EPA has made, and will continue to make, these materials generally available through
Under the CAA, the Administrator is required to approve a SIP submission that complies with the provisions of the Act and applicable federal regulations (42 U.S.C. 7410(k), 40 CFR 52.02(a)). Thus, in reviewing SIP submissions, the EPA's role is to approve state choices, provided that they meet the criteria of the CAA. Accordingly, this final action merely approves some state law as meeting federal requirements; this final
• Is not a “significant regulatory action” subject to review by the Office of Management and Budget under Executive Order 12866 (58 FR 51735, Oct. 4, 1993) and 13563 (76 FR 3821, January 21, 2011);
• This action is not an Executive Order 13771 (82 FR 9339, Feb. 2, 2017) regulatory action because actions such as approving SIPs are exempted under Executive Order 12866;
• Does not impose an information collection burden under the provisions of the Paperwork Reduction Act (44 U.S.C. 3501
• Is certified as not having a significant economic impact on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601
• Does not contain any unfunded mandate or significantly or uniquely affect small governments, as described in the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4);
• Does not have federalism implications as specified in Executive Order 13132 (64 FR 43255, Aug. 10, 1999);
• Is not an economically significant regulatory action based on health or safety risks subject to Executive Order 13045 (62 FR 19885, April 23, 1997);
• Is not a significant regulatory action subject to Executive Order 13211 (66 FR 28355, May 22, 2001);
• Is not subject to requirements of Section 12(d) of the National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272 note) because application of those requirements would be inconsistent with the CAA; and
• Does not provide the EPA with the discretionary authority to address, as appropriate, disproportionate human health or environmental effects, using practicable and legally permissible methods, under Executive Order 12898 (59 FR 7629, Feb. 16, 1994).
The SIP is not approved to apply on any Indian reservation land or in any other area where the EPA or an Indian tribe has demonstrated that a tribe has jurisdiction. In those areas of Indian country, the rule does not have tribal implications and will not impose substantial direct costs on tribal governments or preempt tribal law as specified by Executive Order 13175 (65 FR 67249, November 9, 2000).
The Congressional Review Act, 5 U.S.C. 801
Under section 307(b)(1) of the CAA, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by November 19, 2018. Filing a petition for reconsideration by the Administrator of this final rule does not affect the finality of this action for the purposes of judicial review nor does it extend the time within which a petition for judicial review may be filed, and shall not postpone the effectiveness of such rule or action. This action may not be challenged later in proceedings to enforce its requirements. (See CAA section 307(b)(2).)
Environmental protection, Air pollution control, Carbon monoxide, Incorporation by reference, Intergovernmental relations, Lead, Nitrogen dioxide, Ozone, Particulate matter, Reporting and recordkeeping requirements.
40 CFR part 52 is amended as follows:
42 U.S.C. 7401
The revisions read as follows:
(c) * * *
Environmental Protection Agency (EPA).
Final rule.
The Environmental Protection Agency (EPA) is approving elements of State Implementation Plan (SIP) revisions from the State of Utah to demonstrate the State meets infrastructure monitoring requirements of the Clean Air Act (Act or CAA) for the National Ambient Air Quality Standards (NAAQS) promulgated for lead (Pb) on October 15, 2008, nitrogen dioxide (NO
This rule is effective on October 22, 2018.
The EPA has established a docket for this action under Docket ID No. EPA-R08-OAR-2018-0388-0001. All documents in the docket are listed on the
Kate Gregory, Air Program, U.S. Environmental Protection Agency (EPA), Region 8, Mail Code 8P-AR, 1595 Wynkoop Street, Denver, Colorado 80202-1129, (303) 312-6175,
Throughout this document “we,” “us,” and “our” means the EPA.
The background for this action is discussed in detail in our July 23, 2018 proposal (83 FR 34816). In that document we proposed to approve the State's submittal in reference to infrastructure requirements for CAA section 110(a)(2)(B), element B: Ambient air quality monitoring/data system. In the proposal, we find that Utah's SIP and practices are adequate for the
The EPA received six anonymous comments on the proposal. After reviewing the comments, the EPA has determined that the comments are outside the scope of our proposed action or fail to identify any material issue necessitating a response. All comments received on this action are available for review in the docket for this rulemaking. This rule will be finalized as proposed without revisions.
We are approving infrastructure element B for the 2008 Pb, 2010 SO
For the basis of our approval, please refer to the July 23, 2018 proposal (83 FR 34816).
Under the Clean Air Act, the Administrator is required to approve a SIP submission that complies with the provisions of the Act and applicable federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a). Thus, in reviewing SIP submissions, the EPA's role is to approve state choices, provided that they meet the criteria of the Clean Air Act. Accordingly, this action merely approves state law as meeting federal requirements and does not impose additional requirements beyond those imposed by state law. For that reason, this action:
• Is not a “significant regulatory action” subject to review by the Office of Management and Budget under Executive Orders 12866 (58 FR 51735, October 4, 1993) and 13563 (76 FR 3821, January 21, 2011);
• Is not an Executive Order 13771 (82 FR 9339, February 2, 2017) regulatory action because SIP approvals are exempted under Executive Order 12866;
• Does not impose an information collection burden under the provisions of the Paperwork Reduction Act (44 U.S.C. 3501
• Is certified as not having a significant economic impact on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601
• Does not contain any unfunded mandate or significantly or uniquely affect small governments, described in the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4);
• Does not have federalism implications as specified in Executive Order 13132 (64 FR 43255, August 10, 1999);
• Is not an economically significant regulatory action based on health or safety risks subject to Executive Order 13045 (62 FR 19885, April 23, 1997);
• Is not a significant regulatory action subject to Executive Order 13211 (66 FR 28355, May 22, 2001);
• Is not subject to requirements of section 12(d) of the National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272 note) because application of those requirements would be inconsistent with the CAA; and
• Does not provide the EPA with the discretionary authority to address, as appropriate, disproportionate human health or environmental effects, using practicable and legally permissible methods, under Executive Order 12898 (59 FR 7629, February 16, 1994).
The Congressional Review Act, 5 U.S.C. 801
Under section 307(b)(1) of the Clean Air Act, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by November 19, 2018. Filing a petition for reconsideration by the Administrator of this final rule does not affect the finality of this action for the purposes of judicial review nor does it extend the time within which a petition for judicial review may be filed, and shall not postpone the effectiveness of such rule or action. This action may not be challenged later in proceedings to enforce its requirements. (See section 307(b)(2).)
Environmental protection, Air pollution control, Carbon monoxide, Incorporation by reference, Intergovernmental relations, Greenhouse gases, Lead, Nitrogen dioxide, Ozone, Particulate matter, Reporting and recordkeeping requirements, Sulfur oxides, Volatile organic compounds.
40 CFR part 52 is amended to follows:
42 U.S.C. 7401
(d) The Utah Department of Environmental Quality submitted certification of Utah's infrastructure SIP for the 2008 Pb NAAQS on January 19, 2012; 2010 NO
Environmental Protection Agency (EPA).
Final rule.
The Clean Air Act (CAA) requires each State Implementation Plan (SIP) to contain adequate provisions prohibiting emissions that will have certain adverse air quality effects in other states. On February 7, 2018, the State of Washington made a submittal to the Environmental Protection Agency (EPA) to address these requirements for the 2015 ozone National Ambient Air Quality Standards (NAAQS). The EPA is approving the submittal as meeting the requirement that each SIP contain adequate provisions to prohibit emissions that will significantly contribute to nonattainment or interfere with maintenance of the 2015 ozone NAAQS in any other state.
This final rule is effective October 22, 2018.
The EPA has established a docket for this action under Docket ID No. EPA-R10-OAR-2018-0061. All documents in the docket are listed on the
Jeff Hunt at (206) 553-0256, or
Throughout this document wherever “we,” “us,” or “our” is used, it is intended to refer to the EPA.
On July 23, 2018, the EPA proposed to approve Washington as meeting the requirement that each SIP contain adequate provisions to prohibit emissions that will contribute significantly to nonattainment or interfere with maintenance of the 2015 ozone NAAQS in any other state (83 FR 34813). An explanation of the Clean Air Act requirements, a detailed analysis of the submittal, and the EPA's reasons for proposing approval were provided in the notice of proposed rulemaking, and will not be restated here. The public comment period for the proposal ended August 22, 2018.
We received several anonymous comments unrelated to Washington's submission. After reviewing the anonymous comments, we have determined that the comments are outside the scope of our proposed action and fail to identify any material issue necessitating a response. For more information, please see our memorandum included in the docket for this action.
The EPA is approving Washington's February 7, 2018, submittal certifying that the SIP is sufficient to meet the interstate transport requirements of Clean Air Act section 110(a)(2)(D)(i)(I) for the 2015 ozone NAAQS.
Under the Clean Air Act, the Administrator is required to approve a SIP submission that complies with the provisions of the Clean Air Act and applicable federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a). Thus, in reviewing SIP submissions, the EPA's role is to approve state choices, provided that they meet the criteria of the Clean Air Act. Accordingly, this action merely approves state law as meeting federal requirements and does not impose additional requirements beyond those imposed by state law. For that reason, this action:
• Is not a “significant regulatory action” subject to review by the Office of Management and Budget under Executive Orders 12866 (58 FR 51735, October 4, 1993) and 13563 (76 FR 3821, January 21, 2011);
• is not an Executive Order 13771 (82 FR 9339, February 2, 2017) regulatory action because actions such as SIP approvals are exempted under Executive Order 12866;
• does not impose an information collection burden under the provisions of the Paperwork Reduction Act (44 U.S.C. 3501
• is certified as not having a significant economic impact on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601
• does not contain any unfunded mandate or significantly or uniquely affect small governments, as described in the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4);
• does not have Federalism implications as specified in Executive Order 13132 (64 FR 43255, August 10, 1999);
• is not an economically significant regulatory action based on health or safety risks subject to Executive Order 13045 (62 FR 19885, April 23, 1997);
• is not a significant regulatory action subject to Executive Order 13211 (66 FR 28355, May 22, 2001);
• is not subject to requirements of Section 12(d) of the National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272 note) because this action does not involve technical standards; and
• does not provide the EPA with the discretionary authority to address, as appropriate, disproportionate human health or environmental effects, using practicable and legally permissible methods, under Executive Order 12898 (59 FR 7629, February 16, 1994).
The SIP is not approved to apply on any Indian reservation land and is also not approved to apply in any other area where the EPA or an Indian tribe has demonstrated that a tribe has jurisdiction. In those areas of Indian country, the rule does not have tribal implications as specified by Executive Order 13175 (65 FR 67249, November 9, 2000).
The Congressional Review Act, 5 U.S.C. 801
Under section 307(b)(1) of the Clean Air Act, petitions for judicial review of
Environmental protection, Air pollution control, Carbon monoxide, Incorporation by reference, Intergovernmental relations, Lead, Nitrogen dioxide, Ozone, Particulate matter, Reporting and recordkeeping requirements, Sulfur oxides, Volatile organic compounds.
42 U.S.C. 7401
For the reasons set forth in the preamble, 40 CFR part 52 is amended as follows:
42 U.S.C. 7401
(e) * * *
Environmental Protection Agency (EPA).
Final rule.
Pursuant to the Federal Clean Air Act (CAA or the Act), the Environmental Protection Agency (EPA) is approving portions of the Arkansas State Implementation Plan (SIP) submittal addressing the CAA requirement that SIPs address the potential for interstate transport of air pollution to significantly contribute to nonattainment or interfere with maintenance of the 2012 fine particulate matter (PM
This final rule is effective on November 7, 2018.
The EPA has established a docket for this action under Docket ID No EPA-R06-OAR-2017-0435. All documents in the docket are listed on the
Sherry Fuerst, 214-665-6454,
Throughout this document “we,” “us,” and “our” means the EPA. We selected a November 7, 2018 effective date for this final rule in order for the CFR to reflect this approval and our August 8, 2018 approval of Arkansas Regulation 19 Chapter 2 (83 FR 38964) which has an effective date of November 6, 2018.
The background for this action is discussed in detail in our June 26, 2018 proposal (83 FR 30622). In that document we proposed to approve portions of Arkansas' State Implementation Plan (SIP) March 24, 2017 submittal, that addresses a CAA requirement that SIPs account for potential interstate transport of air pollution that significantly contributes to nonattainment or interferes with maintenance of the 2012 PM
We received four anonymous public comments on the proposed rulemaking action. The comments are posted to the docket (EPA-R06-OAR-2017-0435). In the first comment, received on July 31, 2018, the commenter discusses the costs of renewable energy in Europe and in the northeast United States. Such comment is irrelevant and is outside the scope of this specific rule making action. In the second comment, received July 31, 2018 the commenter discusses the use of child labor in rare earth mining, and the dangers associated with this type of mining. Such comment is irrelevant and outside the scope of this specific rule making action. In the third comment, received July 31, 2018 the commenter discusses the CO2 emissions produced by forest fires. Such comment is irrelevant and outside the scope of this specific rule making action. In the fourth comment, received on July 31, 2018, the commenter provided personal observations regarding the Administration. Such comments are irrelevant and outside the scope of this specific rule making action. Since these comments are not relevant to the specific action EPA proposed, the EPA will not be responding to these comments or making any changes to our proposed rulemaking.
Pursuant to section 110 of the CAA we are approving the following revisions to the Arkansas SIP submitted on March 24, 2017:
• The portion of the Arkansas SIP submittal, pertaining to interstate transport of air pollution, that establishes emissions from Arkansas will not significantly contribute to nonattainment or interfere with maintenance of the 2012 PM
• The portion of the Arkansas SIP submittal that revised the definition of NAAQS in Regulation 19, Chapter 2 and revised the entry for “Particle Pollution, PM
We find that emissions from Arkansas sources do not contribute significantly to nonattainment in, or interfere with maintenance by, any other state with regard to the 2012 PM
In this rule, the EPA is finalizing regulatory text that includes incorporation by reference. In accordance with requirements of 1 CFR 51.5, the EPA is finalizing the incorporation by reference of the revisions to the Arkansas regulations as described in the Final Action section above. The EPA has made, and will continue to make, these materials generally available through
Under the Clean Air Act, the Administrator is required to approve a SIP submission that complies with the provisions of the Act and applicable Federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a). Thus, in reviewing SIP submissions, the EPA's role is to approve state choices, provided that they meet the criteria of the Clean Air Act. Accordingly, this action merely approves state law as meeting Federal requirements and does not impose additional requirements beyond those imposed by state law. For that reason, this action:
• Is not a “significant regulatory action” subject to review by the Office of Management and Budget under Executive Orders 12866 (58 FR 51735, October 4, 1993) and 13563 (76 FR 3821, January 21, 2011);
• Is not an Executive Order 13771 (82 FR 9339, February 2, 2017) regulatory action because SIP approvals are exempted under Executive Order 12866;
• Does not impose an information collection burden under the provisions of the Paperwork Reduction Act (44 U.S.C. 3501
• Is certified as not having a significant economic impact on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601
• Does not contain any unfunded mandate or significantly or uniquely affect small governments, described in the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4);
• Does not have Federalism implications as specified in Executive Order 13132 (64 FR 43255, August 10, 1999);
• Is not an economically significant regulatory action based on health or safety risks subject to Executive Order 13045 (62 FR 19885, April 23, 1997);
• Is not a significant regulatory action subject to Executive Order 13211 (66 FR 28355, May 22, 2001);
• Is not subject to requirements of section 12(d) of the National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272 note) because application of those requirements would be inconsistent with the CAA; and
• Does not provide EPA with the discretionary authority to address, as appropriate, disproportionate human health or environmental effects, using practicable and legally permissible methods, under Executive Order 12898 (59 FR 7629, February 16, 1994).
In addition, the SIP is not approved to apply on any Indian reservation land or in any other area where EPA or an Indian tribe has demonstrated that a tribe has jurisdiction. In those areas of Indian country, the rule does not have tribal implications and will not impose substantial direct costs on tribal governments or preempt tribal law as specified by Executive Order 13175 (65 FR 67249, November 9, 2000).
The Congressional Review Act, 5 U.S.C. 801
Under section 307(b)(1) of the Clean Air Act, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by November 19, 2018. Filing a petition for reconsideration by the Administrator of this final rule does not affect the finality of this action for the purposes of judicial review nor does it extend the time within which a petition for judicial review may be filed, and shall not postpone the effectiveness of such rule or action. This action may not be challenged later in proceedings to enforce its requirements. (See section 307(b)(2).)
Environmental protection, Air pollution control, Incorporation by reference, Particulate matter.
Therefore, 40 CFR part 52 is amended as follows:
42 U.S.C. 7401
The revisions read as follows:
(c) * * *
(e) * * *
Environmental Protection Agency (EPA).
Final rule.
The Environmental Protection Agency (EPA) is taking final action to redesignate the Missouri portion of the St. Louis-St. Charles-Farmington, MO-IL nonattainment area (“St. Louis area” or “area”) to attainment for the 2008 ozone National Ambient Air Quality Standard (NAAQS). EPA is also approving, as a revision to the Missouri State Implementation Plan (SIP), the state's plan for maintaining the 2008 8-hour ozone NAAQS through 2030. Finally, EPA finds adequate and is approving, as a SIP revision, the State's 2030 volatile organic compound (VOC) and oxides of nitrogen (NO
This final rule is effective on September 20, 2018.
EPA has established a docket for this action under Docket ID No. EPA-R07-OAR-2017-0349. All documents in the docket are listed on the
Lachala Kemp, Environmental Protection Agency, Air Planning and Development Branch, 11201 Renner Boulevard, Lenexa, Kansas 66219 at (913) 551-7214, or by email at
Throughout this document “we,” “us,” and “our” refer to EPA. This section provides additional information by addressing the following:
This final rulemaking takes final action on submissions from MDNR dated September 12, 2016, and supplemented on February 16, 2018, requesting redesignation of the Missouri portion of the St. Louis area attainment for the 2008 ozone NAAQS. The background for this action is discussed in detail in EPA's proposed rulemaking published in the
As discussed in the June 25, 2018, proposal, quality-assured and certified monitoring data for 2013-2015 show that the St. Louis area has attained the 2008 ozone standard. In the maintenance plan submitted for the area, Missouri has demonstrated that the ozone standard will be maintained in the area through 2030. Finally, Missouri adopted 2030 MVEBs for its portion of the St. Louis area that are adequate and supported by MDNR's maintenance demonstration.
The state's submission has met the public notice requirements for the redesignation request and maintenance plan submission in accordance with 40 CFR 51.102. The submission also satisfied the completeness criteria of 40 CFR part 51, appendix V. The state held a public comment period from June 27, 2016, to August 4, 2016, and received six comments from three commenters. A public hearing was held on July 28, 2016.
EPA provided a thirty-day review and comment period for the June 25, 2018 proposed rule. The comment period ended on July 25, 2018. EPA received three sets of comments, specifically adverse comments from the Missouri Department of Natural Resources (MDNR) and the Sierra Club. Full sets of these comments are provided in the docket for this final action. A summary of the adverse comments and EPA's responses are provided below.
EPA's proposed rulemaking was based on quality assured data from 2013-2015 which demonstrated that the St. Louis area is attaining the 2008 ozone NAAQS. In addition, 2014-2016 and 2015-2017 data confirm that the area continues to attain that NAAQS. EPA's ozone season runs from March-October and data collected thus far in 2018 has yet to be quality assured or certified by the state. Individual readings at air quality monitors that exceed the level of the NAAQS do not mean that an area is no longer attaining the NAAQS. In part because ozone concentrations are influenced by meteorology and subject to variable conditions, attainment of the 2008 ozone NAAQS is measured using the three-year average design value at all monitoring sites in the area. Moreover, as stated in the proposal, the St. Louis area has also shown a decrease in both NO
EPA has determined that the Missouri portion of the St. Louis nonattainment area is attaining the 2008 ozone standard based on quality-assured and certified monitoring data for 2013-2015 and that the Missouri portion of the St. Louis area has met the requirements for redesignation under section 107(d)(3)(E) of the CAA.
EPA is thus approving the state's request to change the designation of the Missouri portion of the St. Louis area for the 2008 ozone standard from nonattainment to attainment. EPA is also approving, as a revision to the Missouri SIP, the state's maintenance plan for the area. The maintenance plan is designed to keep the Missouri portion of the St. Louis area in attainment of the 2008 ozone NAAQS through 2030. Finally, EPA finds adequate and is approving the newly-established 2030 MVEBs for the Missouri portion of the St. Louis area.
EPA has determined that these actions are effective immediately upon publication under the authority of 5 U.S.C. 553(d). The purpose of the thirty-day waiting period prescribed in section 553(d) is to give affected parties a reasonable time to adjust their behavior and prepare before the final rule takes effect. Section 553(d)(1) allows an effective date less than thirty days after publication if a substantive rule “relieves a restriction.” These actions qualify for the exception under section 553(d)(1) because they relieve the State of various requirements for the Area. Furthermore, section 553(d)(3) allows an effective date less than thirty days after publication “as otherwise provided by the agency for good cause found and published with the rule.” EPA finds good cause to make these actions effective immediately pursuant to section 553(d)(3) because they do not create any new regulatory requirements such that affected parties would need time to prepare before the actions take effect.
Under the Clean Air Act, the Administrator is required to approve a SIP submission that complies with the provisions of the Act and applicable Federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a). Thus, in reviewing SIP submissions, EPA's role is to approve state choices, provided that they meet the criteria of the CAA. Accordingly, this action merely approves state law as meeting Federal requirements and does not impose additional requirements beyond those imposed by state law. For that reason, this action:
• Is not a significant regulatory action subject to review by the Office of Management and Budget under Executive Orders 12866 (58 FR 51735, October 4, 1993) and 13563 (76 FR 3821, January 21, 2011);
• Is not an Executive Order 13771 (82 FR 9339, February 2, 2017) regulatory action because SIP approvals are exempted under Executive Order 12866.
• Does not impose an information collection burden under the provisions of the Paperwork Reduction Act (44 U.S.C. 3501
• Is certified as not having a significant economic impact on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601
• Does not contain any unfunded mandate or significantly or uniquely affect small governments, as described in the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4);
• Does not have Federalism implications as specified in Executive Order 13132 (64 FR 43255, August 10, 1999);
• Is not an economically significant regulatory action based on health or safety risks subject to Executive Order 13045 (62 FR 19885, April 23, 1997);
• Is not a significant regulatory action subject to Executive Order 13211 (66 FR 28355, May 22, 2001);
• Is not subject to requirements of the National Technology Transfer and Advancement Act (NTTA) because this rulemaking does not involve technical standards; and
• Does not provide EPA with the discretionary authority to address, as appropriate, disproportionate human health or environmental effects, using practicable and legally permissible methods, under Executive Order 12898 (59 FR 7629, February 16, 1994).
In addition, the SIP is not approved to apply on any Indian reservation land or in any other area where EPA or an Indian tribe has demonstrated that a tribe has jurisdiction. In those areas of Indian country, the rule does not have tribal implications and will not impose substantial direct costs on tribal governments or preempt tribal law as specified by Executive Order 13175 (65 FR 67249, November 9, 2000).
The Congressional Review Act, 5 U.S.C. 801
Environmental protection, Air pollution control, Incorporation by reference, Intergovernmental relations, Nitrogen dioxide, Ozone, Volatile organic compounds.
Environmental protection, Administrative practice and procedure, Air pollution control, Designations and classifications, Intergovernmental relations, Nitrogen dioxide, Ozone, Reporting and recordkeeping requirements, Volatile organic compounds.
For the reasons stated in the preamble, EPA amends 40 CFR parts 52 and 81 as set forth below:
42 U.S.C. 7401
(e)
42 U.S.C. 7401,
Federal Transit Administration (FTA), Department of Transportation.
Final rule.
This rulemaking rescinds the regulation implementing the requirement for recipients to conduct a cost-effectiveness analysis before leasing public transportation equipment or facilities with Federal transit funds. The requirement to conduct a cost-effectiveness analysis was rescinded by statute in 2015.
This final rule is effective on September 20, 2018.
Mark Montgomery, Office of Chief
This document is viewable online through the Federal eRulemaking portal at
49 CFR part 639 limits capital leasing arrangements for use in public transportation to those that are more cost-effective than purchase or construction. This part implements section 3003 of the Transportation Equity Act for the 21st Century (Pub. L. 105-178) (TEA-21), which amended section 5302 of title 49, United States Code (Section 5302), to allow a recipient to use capital funds to finance the leasing of facilities and equipment on the condition that the leasing arrangements are more cost-effective than purchase or construction. This section also required the Secretary to promulgate regulations to implement the cost-effectiveness limitation. Recently, section 3002 of the Fixing America's Surface Transportation Act (Pub. L. 114-357) (FAST Act) amended the definition of “capital project” under section 5302 to remove this requirement and the mandate to promulgate regulations to carry out this requirement. For this reason, FTA is issuing this final rule to rescind 49 CFR part 639.
FTA will continue to evaluate its regulations and guidance to promote improvements to the capital leasing process in the least burdensome manner.
Under the amended statutory definition of “capital project,” capital leases are no longer subject to the requirement or regulation limiting leasing arrangements to those that are more cost-effective than purchase or construction. Accordingly, this rulemaking rescinds 49 CFR part 639, which outlines the procedures for conducting the cost-effectiveness analysis. This rule does not affect the general procurement standards in 2 CFR part 200, nor does it alter the award management requirements in FTA's Circular 5010.1E.
Under the Administrative Procedure Act (APA) (5 U.S.C. 553(b)), an agency may waive the normal notice and comment procedure if it finds, for good cause, that it is impracticable, unnecessary, or contrary to the public interest. Additionally, 5 U.S.C. 553(d) provides that an agency may waive the 30-day delayed effective date upon finding of good cause.
Section 3003 of TEA-21 amended section 5302 to allow a recipient to use capital funds to finance the leasing of facilities and equipment, “subject to regulations that the Secretary prescribes limiting the leasing arrangements to those that are more cost-effective than purchase or construction.” By removing this language, section 3002 of the FAST Act eliminated the requirement limiting capital leases to those that are more cost-effective than purchase or construction. FTA finds good cause that notice and comment for this rule is unnecessary due to the nature of the revisions (
FTA has determined that this rulemaking is not a significant regulatory action within the meaning of Executive Order 12866, and within the meaning of DOT regulatory policies and procedures. This action complies with Executive Orders 12866, 13563 and 13771 to improve regulation.
FTA classifies this rule as a deregulatory action under Executive Order 13771, because it removes the mandatory cost-effectiveness analysis. FTA finds that the cost savings are minor. On average, there are twelve leases per year subject to the requirement, and the analysis takes approximately a week for transit agencies to compile and prepare and approximately eight hours for FTA to review and approve the certification. Thus, removing these requirements would provide a maximum average annual cost savings of $32,373 and impose no additional costs on recipients.
Because FTA finds good cause under 5 U.S.C. 553(b)(3)(B) to waive notice and opportunity for comment for this rule, the provisions of the Regulatory Flexibility Act (Pub. L. 96-354, 5 U.S.C. 601-612) do not apply. FTA evaluated the effects of this action on small entities and determined the action would not have a significant economic impact on a substantial number of small entities. FTA hereby certifies that this rule will not have a significant economic impact on a substantial number of small entities.
FTA has determined that this rule does not impose unfunded mandates, as defined by the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4, March 22, 1995, 109 Stat. 48). This rule does not include a Federal mandate that may result in expenditures of $155.1 million or more in any 1 year (when adjusted for inflation) in 2012 dollars for either State, local, and tribal governments in the aggregate, or by the private sector. Additionally, the definition of “Federal mandate” in the Unfunded Mandates Reform Act excludes financial assistance of the type in which State, local, or tribal governments have authority to adjust their participation in the program in accordance with changes made in the program by the Federal Government. The Federal Transit Act permits this type of flexibility.
Executive Order 13132 requires agencies to assure meaningful and timely input by State and local officials in the development of regulatory policies that may 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. This action has been analyzed in accordance with the principles and criteria contained in Executive Order 13132 dated August 4, 1999, and FTA determined this action will not have a substantial direct effect
The regulations implementing Executive Order 12372 regarding intergovernmental consultation on Federal programs and activities apply to this program.
Federal agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct, sponsor, or require through regulations. FTA has analyzed this rule under the Paperwork Reduction Act and believes that it does not impose additional information collection requirements for the purposes of the Act above and beyond existing information collection clearances from OMB.
Federal agencies are required to adopt implementing procedures for the National Environmental Policy Act (NEPA) that establish specific criteria for, and identification of, three classes of actions: (1) Those that normally require preparation of an Environmental Impact Statement, (2) those that normally require preparation of an Environmental Assessment, and (3) those that are categorically excluded from further NEPA review (40 CFR 1507.3(b)). This rule qualifies for categorical exclusions under 23 CFR 771.118(c)(4) (planning and administrative activities that do not involve or lead directly to construction). FTA has evaluated whether the rule will involve unusual or extraordinary circumstances and has determined that it will not.
FTA has analyzed this rule under Executive Order 12630, Governmental Actions and Interference with Constitutionally Protected Property Rights. FTA does not believe this rule effects a taking of private property or otherwise has taking implications under Executive Order 12630.
This 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.
FTA has analyzed this rule under Executive Order 13045, Protection of Children from Environmental Health Risks and Safety Risks. FTA certifies that this action will not cause an environmental risk to health or safety that might disproportionately affect children.
FTA has analyzed this rule under Executive Order 13175, dated November 6, 2000, and believes that it will not have substantial direct effects on one or more Indian tribes; will not impose substantial direct compliance costs on Indian tribal governments; and will not preempt tribal laws. Therefore, a tribal summary impact statement is not required.
FTA has analyzed this action under Executive Order 13211, Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use. FTA has determined that this action is not a significant energy action under that order and is not likely to have a significant adverse effect on the supply, distribution, or use of energy. Therefore, a Statement of Energy Effects is not required.
Executive Order 12898 (Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations) and DOT Order 5610.2(a) (77 FR 27534, May 10, 2012) (available online at
FTA has evaluated this action under the Executive Order, the DOT Order, and the FTA Circular. The rule rescinds the requirement of conducting cost-effectiveness analysis for capital leases, and FTA has determined that this action will not cause disproportionately high and adverse human health and environmental effects on minority or low-income populations.
A Regulation Identifier Number (RIN) is assigned to each regulatory action listed in the Unified Agenda of Federal Regulations. The Regulatory Information Service Center publishes the Unified Agenda in April and October of each year. The RIN number contained in the heading of this document can be used to cross-reference this rule with the Unified Agenda.
Grant programs—transportation, Mass transportation.
Federal Aviation Administration (FAA), DOT.
Notice of proposed rulemaking (NPRM).
This action proposes to amend Class E airspace extending upward from 700 feet above the surface in Mountain City, TN, to accommodate new area navigation (RNAV) global positioning system (GPS) standard instrument approach procedures serving Johnson County Airport. In addition, Class E airspace extending upward from 700 feet above the surface would be established in Elizabethton, TN to accommodate area navigation (RNAV) global positioning system (GPS) standard instrument approach procedures at Elizabethton Municipal Airport. Controlled airspace is necessary for the safety and management of instrument flight rules (IFR) operations at these airports.
Comments must be received on or before November 5, 2018.
Send comments on this proposal to: The U.S. Department of Transportation, Docket Operations, 1200 New Jersey Avenue SE, West Building Ground Floor, Room W12-140, Washington, DC 20590-0001; Telephone: (800) 647-5527, or (202) 366-9826. You must identify the Docket No. FAA-2018-0745; Airspace Docket No. 18-ASO-15, at the beginning of your comments. You may also submit comments through the internet at
FAA Order 7400.11C, Airspace Designations and Reporting Points, and subsequent amendments can be viewed on line at
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, 1701 Columbia Avenue, College Park, GA 30337; 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 Johnson County Airport, Mountain City, TN, and establish Class E airspace at Elizabethton Municipal, Elizabethton, TN, to support IFR operations at these airports.
Interested persons are invited to comment on this proposed rulemaking 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 (Docket No. FAA-2018-0745 and Airspace Docket No. 18-ASO-15) and be submitted in triplicate to DOT Docket Operations (see
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 FAA Docket No. FAA-2018-0745; Airspace Docket No. 18-ASO-15.” 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 document may be changed in light of the comments received. All comments submitted will be available for examination in the public docket both before and after the comment closing date. 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 through the internet at
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 7400.11C, Airspace Designations and Reporting Points, dated August 13, 2018, and effective September 15, 2018. FAA Order 7400.11C is publicly available as listed in the
The FAA proposes an amendment to Title 14 Code of Federal Regulations (14 CFR) part 71 to amend Class E airspace extending upward from 700 feet or more above the surface at Johnson County Airport, Mountain City, TN, by increasing the northeast extension to 14.4 miles (from 10.9 miles), and creating a 14-mile extension southwest of the airport, to accommodate new area navigation (RNAV) global positioning system (GPS) standard instrument approach procedures at the airport.
Additionally, Class E airspace extending upward from 700 feet above the surface would be established at Elizabethton Municipal Airport, Elizabethton, TN, within a 9.5-mile radius of the airport, and within 4-miles each side of the 243° bearing from the airport, extending from the 9.5-mile radius to 15-miles southwest of the airport to accommodate RNAV (GPS) standard instrument approach procedures for IFR operations at these airports.
Class E airspace designations are published in Paragraph 6005, of FAA Order 7400.11C, dated August 13, 2018, and effective September 15, 2018, 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 will 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 700 feet above the surface within a 6.7-mile radius of the Johnson County Airport, and within 3.2 miles each side of the 066° bearing from the airport, extending from the 6.7-mile radius to 14.4 miles northeast of the airport, and within 3.2 miles each side of the 251° bearing from the airport, extending from the 6.7-mile radius to 14-miles southwest of the airport.
That airspace extending upward from 700 feet above the surface within a 9.5-mile radius of Elizabethton Municipal Airport, and within 4-miles each side of the 243° bearing from the airport, extending from the 9.5-mile radius to 15-miles southwest of the airport.
Federal Aviation Administration (FAA), DOT.
Notice of proposed rulemaking (NPRM).
This action proposes to amend Class D airspace at Oakland County International Airport, Pontiac, MI. The FAA is proposing this action as the result of an airspace review caused by the decommissioning of the Pontiac VHF omnidirectional range (VOR) navigation aid, which provided navigation information for the instrument procedures at this airport, as part of the VOR Minimum Operational Network (MON) Program. This action would also replace the outdated term Airport/Facility Directory with Chart Supplement. Airspace redesign is necessary for the safety and management of instrument flight rules (IFR) operations at this airport.
Comments must be received on or before November 5, 2018.
Send comments on this proposal to the U.S. Department of Transportation, Docket Operations, West Building Ground Floor, Room W12-140, 1200 New Jersey Avenue SE, Washington, DC 20590; telephone (202) 366-9826, or (800) 647-5527. You must identify FAA Docket No. FAA-2018-0698; Airspace Docket No. 18-AGL-20, at the beginning of your comments. You may also submit comments through the internet at
FAA Order 7400.11C, Airspace Designations and Reporting Points, and subsequent amendments can be viewed online at
FAA Order 7400.11, Airspace Designations and Reporting Points, is published yearly and effective on September 15.
Jeffrey Claypool, Federal Aviation Administration, Operations Support Group, Central Service Center, 10101 Hillwood Parkway, Fort Worth, TX 76177; telephone (817) 222-5711.
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 D airspace at Oakland County International Airport, Pontiac, MI, to support IFR operations at this airport.
Interested parties are invited to participate in this proposed rulemaking 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. Commenters wishing the FAA to acknowledge receipt of their comments on this notice must submit with those comments a self-addressed, stamped postcard on which the following statement is made: “Comments to Docket No. FAA-2018-0698; Airspace Docket No. 18-AGL-20.” 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 through the internet at
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 7400.11C, Airspace Designations and Reporting Points, dated August 13, 2018, and effective September 15, 2018. FAA Order 7400.11C is publicly available as listed in the
The FAA is proposing an amendment to Title 14 Code of Federal Regulations (14 CFR) part 71 by amending the Class D airspace at Oakland County International Airport, Ponitac, MI, adding an extension 1.0 mile each side of the 274° bearing from the airport extending from the 4.2-mile radius to 4.4 miles west of the airport; and adding an extension 1.0 mile each side of the 275° bearing from the Oakland County Intl: RWY 09R-LOC extending from the 4.2-mile radius to 4.4 miles west of the Oakland County Intl: RWY 09R-LOC.
This action also would make an editorial change to the airspace legal description replacing “Airport/Facility Directory” with “Chart Supplement”.
This action is necessary due to an airspace review caused by the decommissioning of the Pontiac VOR, which provided navigation information to the instrument procedures at this airport, as part of the VOR MON Program.
Class D airspace designations are published in paragraph 5000 of FAA Order 7400.11C, dated August 13, 2018, and effective September 15, 2018, which is incorporated by reference in 14 CFR 71.1. The Class D airspace designation listed in this document will be published subsequently in the Order.
The FAA has determined that this regulation only involves an established body of technical regulations for which frequent and routine amendments are necessary to keep them operationally current, is non-controversial and unlikely to result in adverse or negative comments. 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 rule, when promulgated, would not have a significant economic impact on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.
This proposal will 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).
Accordingly, pursuant to the authority delegated to me, 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 to and including 3,500 feet MSL within a 4.2-mile radius of Oakland County International Airport, and within 1.0 mile each side of the 274° bearing from the airport extending from the 4.2-mile radius to 4.4 miles west of the airport, and within 1.0 mile each side of the 275° bearing from the Oakland County Intl: RWY 09R-LOC extending from the 4.2-mile radius to 4.4 miles from the Oakland County Intl: RWY 09R-LOC. This Class D airspace area is effective during the specific dates and times established in advance by a Notice to Airmen. The effective date and time will thereafter be continuously published in the Chart Supplement.
Federal Aviation Administration (FAA), DOT.
Notice of proposed rulemaking (NPRM).
This action proposes to amend Class D airspace at Coleman A. Young Municipal Airport (formerly Detroit City Airport), Detroit, MI, by changing the airspace designation to Detroit, MI, thereby removing the old airport name. The name and geographic coordinates of the airport also would be updated to coincide with the FAA's aeronautical database. This action is necessary to keep information current for the safety and management of aircraft within the national airspace system.
Comments must be received on or before November 5, 2018.
Send comments on this proposal to the U.S. Department of Transportation, Docket Operations, West Building Ground Floor, Room W12-140, 1200 New Jersey Avenue SE, Washington, DC 20590; telephone (202) 366-9826, or (800) 647-5527. You must identify FAA Docket No. FAA-2018-0685; Airspace Docket No. 18-AGL-19, at the beginning of your comments. You may also submit comments through the internet at
FAA Order 7400.11C, Airspace Designations and Reporting Points, and subsequent amendments can be viewed online at
FAA Order 7400.11, Airspace Designations and Reporting Points, is published yearly and effective on September 15.
Jeffrey Claypool, Federal Aviation Administration, Operations Support Group, Central Service Center, 10101 Hillwood Parkway, Fort Worth, TX 76177; telephone (817) 222-5711.
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 D airspace at Coleman A. Young Memorial Airport, Detroit, MI.
Interested parties are invited to participate in this proposed rulemaking 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. Commenters wishing the FAA to acknowledge receipt of their comments on this notice must submit with those comments a self-addressed, stamped postcard on which the following statement is made: “Comments to Docket No. FAA-2018-0685; Airspace Docket No. 18-AGL-19.” 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
An electronic copy of this document may be downloaded through the internet at
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 7400.11C, Airspace Designations and Reporting Points, dated August 13, 2018, and effective September 15, 2018. FAA Order 7400.11C is publicly available as listed in the
The FAA is proposing an amendment to Title 14 Code of Federal Regulations (14 CFR) part 71 amending the Class D airspace by updating for the location in the header of the airspace legal description to Detroit, MI (previously Detroit City Airport, MI), at Coleman A. Young Municipal Airport (formerly Detroit City Airport), Detroit, MI, to comply with FAA Order 7400.2L, Procedures for Handling Airspace Matters. The name and geographic coordinates of the airport would also be updated to coincide with the FAA's aeronautical database.
Class D airspace designations are published in paragraph 5000 of FAA Order 7400.11C, dated August 13, 2018, and effective September 15, 2018, which is incorporated by reference in 14 CFR 71.1. The Class D airspace designation listed in this document will be published subsequently in the Order.
The FAA has determined that this regulation only involves an established body of technical regulations for which frequent and routine amendments are necessary to keep them operationally current, is non-controversial and unlikely to result in adverse or negative comments. 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 rule, when promulgated, would not have a significant economic impact on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.
This proposal will 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).
Accordingly, pursuant to the authority delegated to me, 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 to and including 3,100 feet MSL within a 4.1-mile radius of the Coleman A. Young Municipal Airport.
Federal Aviation Administration (FAA), DOT.
Notice of proposed rulemaking (NPRM).
This action proposes to establish Class E surface airspace at Dothan Regional Airport, Dothan, AL. The Class E surface airspace would be established for the safety of aircraft landing and departing the airport when the air traffic control tower is closed. Also, this action proposes to amend Class D airspace by updating the airport's name and geographic coordinates, as well as replacing the outdated term `Airport/Facility Directory' with `Chart Supplement'. Additionally, the geographic coordinates of the airport and Wiregrass VORTAC would be adjusted in the associated Class E airspace to match the FAA's aeronautical database; as well as removing the part-time status of the airspace for Class E airspace designated as an extension to a Class D surface area. Controlled airspace is necessary for the safety and management of instrument flight rules (IFR) operations at this airport.
Comments must be received on or before November 5, 2018.
Send comments on this rule 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-2018-0744; Airspace Docket No. 18-ASO-14, at the beginning of
FAA Order 7400.11C, Airspace Designations and Reporting Points, and subsequent amendments can be viewed on line at
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, 1701 Columbia Avenue, College Park, GA 30337; 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 proposed 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 establish Class E surface airspace and amend Class D airspace and Class E airspace at Dothan Regional Airport, Dothan, AL, to support IFR operations at this airport.
Interested persons are invited to comment on this proposed rulemaking 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 (Docket No. FAA-2018-0744 and Airspace Docket No. 18-ASO-14) and be submitted in triplicate to DOT Docket Operations (see
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 FAA Docket No. FAA-2018-0744; Airspace Docket No. 18-ASO-14.” 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 document may be changed in light of the comments received. All comments submitted will be available for examination in the public docket both before and after the comment closing date. A report summarizing each substantive public contact with FAA personnel concerned with this rulemaking will be filed in the docket. All communications received on or 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 through the internet at
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 7400.11C, Airspace Designations and Reporting Points, dated August 13, 2018, and effective September 15, 2018. FAA Order 7400.11C is publicly available as listed in the
The FAA is considering an amendment to Title 14, Code of Federal Regulations (14 CFR) part 71 by:
Amending Class D airspace at Dothan Regional Airport, Dothan, AL by recognizing the airport name change to Dothan Regional Airport (formerly Dothan Airport), and adjusting the geographic coordinates of the airport to be in concert with the FAA's aeronautical database. Also, this action would make an editorial change replacing the term “Airport/Facility Directory” with the term “Chart Supplement” in the airspace legal description;
Establishing Class E surface area airspace within a 4.7-mile radius of Dothan Regional Airport, Dothan, AL, for the safety of aircraft landing and departing the airport after the air traffic control tower closes;
Amending Class E airspace designated as an extension to a Class D surface area by adjusting the geographic coordinates of the airport and the Wiregrass VORTAC to be in concert with the FAA's aeronautical database.
In addition, the part-time status would be removed from this airspace description, as the airspace is continuously active; and
Amending Class E airspace extending upward from 700 feet above the surface at Dothan Regional Airport, Dothan, AL, by adjusting the geographic coordinates of the airport and the Wiregrass VORTAC to be in concert with the FAA's aeronautical database, and by recognizing the airport name change to Dothan Regional Airport (formerly Dothan Airport).
Class D and Class E airspace designations are published in Paragraphs 5000, 6002, 6004, and 6005, respectively of FAA Order 7400.11C, dated August 13, 2018, and effective September 15, 2018, which is incorporated by reference in 14 CFR 71.1. The Class D and Class E airspace designations 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.
(Lat. 31°19′16″ N, long. 85°26′58″ W)
That airspace extending upward from the surface to and including 2,900 feet MSL within a 4.7-mile radius of Dothan Regional Airport. This Class D airspace area is effective during the specific dates and times established in advance by a Notice to Airmen. The effective date and time will thereafter be continuously published in the Chart Supplement.
(Lat. 31°19′16″ N, long. 85°26′58″ W)
That airspace extending upward from the surface within a 4.7-mile radius of Dothan Regional Airport. This Class E surface airspace area is effective during the specific dates and times established in advance by a Notice to Airmen. The effective date and time will thereafter be continuously published in the Chart Supplement.
That airspace extending upward from the surface within 3.2 miles each side of the Wiregrass VORTAC 156° radial, extending from the 4.7-mile radius of Dothan Regional Airport to 7-miles southeast of the VORTAC.
That airspace extending upward from 700 feet above the surface within a 6.7-mile radius of Dothan Regional Airport within 3.2 miles each side of Wiregrass VORTAC 156° radial, extending from the 6.7-mile radius to 7 miles SE of the VORTAC excluding that airspace within the Fort Rucker, AL, Class E airspace area.
Federal Aviation Administration (FAA), DOT.
Notice of proposed rulemaking (NPRM).
This action proposes to amend Class E airspace extending upward from 700 feet above the surface at Cabool Memorial Airport, Cabool, MO. The FAA is proposing this action as the result of an airspace review caused by the decommissioning of the Maples VHF omnidirectional range (VOR) navigation aid, which provided navigation information for the instrument procedures at this airport, as part of the VOR Minimum Operational Network (MON) Program. The geographic coordinates of the airport would also be updated to coincide with the FAA's aeronautical database. This action is necessary for the safety and management of instrument flight rules (IFR) operations at this airport.
Comments must be received on or before November 5, 2018.
Send comments on this proposal to the U.S. Department of Transportation, Docket Operations, 1200 New Jersey Avenue SE, West Building Ground Floor, Room W12-140, Washington, DC 20590; telephone (202) 366-9826, or (800) 647-5527. You must identify FAA Docket No. FAA-2018-0682; Airspace Docket No. 18-ACE-5 at the beginning of your comments. You may also submit comments through the internet at
FAA Order 7400.11C, Airspace Designations and Reporting Points, and
FAA Order 7400.11, Airspace Designations and Reporting Points, is published yearly and effective on September 15.
Jeffrey Claypool, Federal Aviation Administration, Operations Support Group, Central Service Center, 10101 Hillwood Parkway, Fort Worth, TX 76177; telephone (817) 222-5711.
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 extending upward from 700 feet above the surface at Cabool Memorial Airport, Cabool, MO, to support IFR operations at the airport.
Interested parties are invited to participate in this proposed rulemaking 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. Commenters wishing the FAA to acknowledge receipt of their comments on this notice must submit with those comments a self-addressed, stamped postcard on which the following statement is made: “Comments to Docket No. FAA-2018-0682; Airspace Docket No. 18-ACE-5.” 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 through the internet at
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 7400.11C, Airspace Designations and Reporting Points, dated August 13, 2018, and effective September 15, 2018. FAA Order 7400.11C is publicly available as listed in the
The FAA is proposing an amendment to Title 14 Code of Federal Regulations (14 CFR) part 71 that would amend Class E airspace extending upward from 700 feet above the surface at Cabool Memorial Airport, Cabool, MO, by removing the Maples VORTAC and associated extension northeast of the airport. This action would also update the geographic coordinates of the airport to coincide with the FAA's aeronautical database.
This action is necessary due to an airspace review caused by the decommissioning of the Maples VOR, which provided navigation information to the instrument procedures at this airport, as part of the VOR MON Program.
Class E airspace designations are published in paragraphs 6005 of FAA Order 7400.11C, dated August 13, 2018, and effective September 15, 2018, which is incorporated by reference in 14 CFR 71.1. The Class E airspace designations 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, is non-controversial and unlikely to result in adverse or negative comments. 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, would not have a significant economic impact on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.
This proposal will 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).
Accordingly, pursuant to the authority delegated to me, 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 700 feet above the surface within a 6.3-mile radius of Cabool Memorial Airport.
Federal Aviation Administration (FAA), DOT.
Notice of proposed rulemaking (NPRM).
This action proposes to amend Class D airspace and Class E airspace designated as a surface area, and remove Class E airspace designated as an extension to a Class D and Class E airspace at Drake Field, Fayetteville, AR. The FAA is proposing this action as the result of an airspace review caused by the decommissioning of the Drake VHF omnidirectional range (VOR) navigation aid, which provided navigation information for the instrument procedures at this airport, as part of the VOR Minimum Operational Network (MON) Program. The geographic coordinates of the airport would also be updated to coincide with the FAA's aeronautical database.
Comments must be received on or before November 5, 2018.
Send comments on this proposal to the U.S. Department of Transportation, Docket Operations, West Building Ground Floor, Room W12-140, 1200 New Jersey Avenue SE, Washington, DC 20590; telephone (202) 366-9826, or (800) 647-5527. You must identify FAA Docket No. FAA-2018-0699; Airspace Docket No. 18-ASW-11, at the beginning of your comments. You may also submit comments through the internet at
FAA Order 7400.11C, Airspace Designations and Reporting Points, and subsequent amendments can be viewed online at
FAA Order 7400.11, Airspace Designations and Reporting Points, is published yearly and effective on September 15.
Jeffrey Claypool, Federal Aviation Administration, Operations Support Group, Central Service Center, 10101 Hillwood Parkway, Fort Worth, TX 76177; telephone (817) 222-5711.
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 D airspace and Class E airspace designated as a surface area, and remove Class E airspace designated as an extension to a Class D and Class E airspace at Drake Field, Fayetteville, AR, to support instrument flight rule operations at the airport.
Interested parties are invited to participate in this proposed rulemaking 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. Commenters wishing the FAA to acknowledge receipt of their comments on this notice must submit with those comments a self-addressed, stamped postcard on which the following statement is made: “Comments to Docket No. FAA-2018-0699/Airspace Docket No. 18-ASW-11.” 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 through the internet at
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 7400.11C, Airspace Designations and Reporting Points, dated August 13, 2018, and effective September 15, 2018. FAA Order 7400.11C is publicly available as listed in the
The FAA is proposing an amendment to Title 14 Code of Federal Regulations (14 CFR) part 71 by:
Amending the Class D airspace at Drake Field, Fayetteville, AR, to within a 4.0-mile radius (decreased from a 4.1-mile radius); and adding an extension 1.1 miles each side of the 181° bearing from the airport from the 4.0-mile radius to 5.9 miles north of the airport, and adding an extension 1.0 mile each side of the 172° bearing from the Drake Field: RWY 34-LOC from the 4.0-mile radius to 4.9 miles south of the Drake Field: RWY 34-LOC; and adding an extension 1.0 mile each side of the 347° bearing from the airport from the 4.0-mile radius to 4.9 miles north the airport. The city associated with the airport would be removed from the airspace legal description to comply with a change to FAA Order 7400.2L, Procedures for Handling Airspace Matters, and the outdated term “Airport/Facility Directory” would be updated to “Chart Supplement.” Additionally, the geographic coordinates of the airport would be updated to coincide with the FAA's aeronautical database.
Amending the Class E airspace designated as a surface area at Drake Field to within a 4.0-mile radius (decreased from a 4.1-mile radius); and extending the airspace up to and including 3,800 feet MSL; and adding an extension 1.1 miles each side of the 181° bearing from the airport from the 4.0-mile radius to 5.9 miles south of the airport, and adding an extension 1.0 mile each side of the 172° bearing from the Drake Field: RWY 34-LOC from the 4.0-mile radius to 4.9 miles south of the Drake Field: RWY 34-LOC; and adding an extension 1.0 mile each side of the 347° bearing from the airport from the 4.0-mile radius to 4.9 miles north of the airport. The city associated with the airport would be removed from the airspace legal description to comply with a change to FAA Order 7400.2L, Procedures for Handling Airspace Matters, and the outdated term “Airport/Facility Directory” would be updated to “Chart Supplement.” Additionally, the geographic coordinates of the airport would be updated to coincide with the FAA's aeronautical database.
And removing the Class E airspace designated as an extension to Class D and Class E at Drake Field as it is no longer required.
This action as the result of an airspace review caused by the decommissioning of the Drake VOR, which provided navigation information for the instrument procedures at this airport, as part of the VOR MON Program.
Class D and E airspace designations are published in paragraph 5000, 6002, and 6004, respectively, of FAA Order 7400.11C, dated August 13, 2018, and effective September 15, 2018, which is incorporated by reference in 14 CFR 71.1. The Class D and E airspace designations listed in this document will be published subsequently in the Order.
The FAA has determined that this regulation only involves an established body of technical regulations for which frequent and routine amendments are necessary to keep them operationally current, is non-controversial and unlikely to result in adverse or negative comments. 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 rule, when promulgated, would not have a significant economic impact on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.
This proposal will 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).
Accordingly, pursuant to the authority delegated to me, 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 to and including 3,800 feet MSL within a 4.0-mile radius of Drake Field, and within 1.1 miles each side of the 181° bearing from the airport from the 4.0-mile radius to 5.9 miles south of the airport, and within 1.0 mile each sided of the 172° bearing from the Drake Field: RWY 34-LOC from the 4.0-mile radius to 4.9 miles south of the Drake Field: RWY 34-LOC, and within 1.0 mile each side of the 347° bearing from the airport from the 4.0-mile radius to 4.9 miles north of the airport. This Class D airspace area is effective during the specific dates and times established in advance by a Notice to Airmen. The effective date and time will thereafter be continuously published in the Chart Supplement.
That airspace extending upward from the surface to and including 3,800 feet MSL within a 4.0-mile radius of Drake Field, and within 1.1 miles each side of the 181° bearing from the airport from the 4.0-mile radius to 5.9 miles south of the airport, and within 1.0 mile each sided of the 172° bearing from the Drake Field: RWY 34-LOC from the 4.0-mile
National Park Service, Interior.
Proposed rule.
The National Park Service proposes to revise the special regulations for Death Valley National Park to designate the Saline Valley Warm Springs Airfield, commonly known as the Chicken Strip, within the Saline Valley Warm Springs area as a location available for the operation of aircraft.
Comments on the proposed rule must be received by 11:59 p.m. EDT on November 19, 2018.
You may submit comments, identified by Regulation Identifier Number (RIN) 1024-AE48, by either of the following methods:
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Kelly Daigle, National Park Service, Environmental Quality Division, (303) 987-6897,
Saline Valley is a large desert valley located in the northwest portion of Death Valley National Park (the park). The Saline Valley Warm Springs area is approximately 1,100 acres of backcountry surrounded by wilderness. This area is distinctive, both in the setting of the site and in its geology. Saline Valley is a closed basin, which means that the water does not flow to another body of water. Water in closed basins only leaves the system by evaporation or diversion. The Saline Valley Warm Springs are among the highest-flow springs in the park. The mountain ranges surrounding this valley, Saline Range, Last Chance Range, and Inyo Range, have elevations ranging from 7,000 feet to over 11,000 feet, which result in spectacular views from the Saline Valley Warm Springs.
The Timbisha Shoshone Tribe (the Tribe), whose homelands encompass the entirety of the park, has a deep affinity for the Saline Valley Warm Springs area due to the existence of long-lived historical and ethnographic connections. The Timbisha Shoshone Homeland Act of 2000 (Homeland Act; Pub. L. 106-423) specified designated special use areas. Saline Valley is part of one of these special use areas. The waters of the warm springs in Saline Valley are a source of
The Saline Valley Warm Springs area has not been formally or systematically developed for use by the NPS but does have a number of user-developed and user-maintained structures and facilities. Visitors enjoy backcountry camping and soaking tubs created by diverting water from natural source springs. Visitors use the Saline Valley Warm Springs area throughout the year but the cooler months, October to May, receive the highest use; holidays are times of especially heavy use. The Lower Spring area is the most developed and includes the following features: Cool Pool, Sunrise Pool, Crystal Pool, Children's Play Tub, communal fire pit, library, shower, bathtub, sink for dishwashing, maintained lawn, settling pond, auto shop, and the camp host site. It is the site of many communal activities, such as group fires, communal dinners, and singing. The site contains heavy burro concentration and use, and invasive species such as palm trees and Bermuda grass.
There is a small, unimproved landing strip to the west of Lower Spring, referred to as the Chicken Strip. The formal name of the airstrip is the Saline Valley Warm Springs Airfield. The airstrip is located at latitude N 36°48.41″, longitude W 117°46.90″. In past years, there were up to three landing strips for small planes in this area. The Suicide Strip and the Crosswinds Strip have been decommissioned. Historically, the landing strips were used by miners and prospectors to access Saline Valley. The Chicken Strip is the only remaining active landing strip within the Saline Valley Warm Springs area. It is approximately 1,400 feet long and 35 feet wide. The strip has a tie-down area large enough to accommodate five small planes. Features of the airstrip include a windsock, painted rocks lining the strip, and two airplane tie-downs. Visitors who fly into the Saline Valley Warm Springs area via the Chicken Strip often camp next to their airplanes.
The Chicken Strip surface is maintained by the community of recreational pilots who use it. The Recreational Aviation Foundation (RAF), an organization of private pilots, is active in the promotion of the continued use of the Chicken Strip. In 2017, the NPS renewed a memorandum of understanding (MOU) with the RAF that allows the RAF to maintain the Chicken Strip at no cost to the NPS. Maintenance activities include leveling the surface, removing stones and debris, and packing the surface.
Based on visitor registration logs at the Chicken Strip, approximately 440 people visited Saline Valley via airplane from 2008 to 2012, averaging 88 visitors per year. Of the aircraft reported, approximately two-thirds were Cessna models. Other types of planes included various models of Pipers, Maules, and Beechcraft. The largest number of people recorded in one aircraft was six.
This rule would designate the Chicken Strip airstrip as available for use by aircraft. This action would implement part of the preferred alternative identified in the 2018 Saline Valley Warm Springs Draft Management Plan/Environmental Impact Statement (DEIS). The airstrip has been in use since before the NPS began managing the Saline Valley Warm Springs area in 1994 and this rule would codify the continued use of the airstrip. National Park Service (NPS) regulations at 36 CFR 2.17(a)(1) prohibit the operation or use of an aircraft on lands or waters other than at locations designated pursuant to a special regulation.
This rule would also remove references to “Death Valley National Monument” and “Monument” in section 2.17 and replace them with references to “Death Valley National Park” and “Park”. This reflects the abolishment of Death Valley National Monument and the establishment of Death Valley National Park in 1994. 16 U.S.C. 410aaaa-1.
Executive Order 12866 provides that the Office of Information and Regulatory Affairs in the Office of Management and Budget will review all significant rules. The Office of Information and Regulatory Affairs has determined that this rule is not significant.
Executive Order 13563 reaffirms the principles of Executive Order 12866 while calling for improvements in the nation's regulatory system to promote predictability, to reduce uncertainty, and to use the best, most innovative, and least burdensome tools for achieving regulatory ends. The executive order directs agencies to consider regulatory approaches that reduce burdens and maintain flexibility and freedom of choice for the public where these approaches are relevant, feasible, and consistent with regulatory objectives. Executive Order 13563 emphasizes further that regulations must be based on the best available science and that the rulemaking process must allow for public participation and an open exchange of ideas. The NPS has developed this rule in a manner consistent with these requirements.
Enabling regulations are considered deregulatory under guidance implementing E.O. 13771 (M-17-21). This rule authorizes the Superintendent to allow a recreational activity for the public to enjoy and experience certain areas within the National Park System that would otherwise be prohibited.
This rule will not have a significant economic effect on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601
This rule is not a major rule under 5 U.S.C. 804(2), the Small Business Regulatory Enforcement Fairness Act. This rule:
(a) Does not have an annual effect on the economy of $100 million or more.
(b) Will not cause a major increase in costs or prices for consumers, individual industries, Federal, State, or local government agencies, or geographic regions.
(c) Does not have significant adverse effects on competition, employment, investment, productivity, innovation, or the ability of U.S. based enterprises to compete with foreign-based enterprises.
This rule does not impose an unfunded mandate on State, local, or tribal governments or the private sector of more than $100 million per year. The rule does not have a significant or unique effect on State, local or tribal governments or the private sector. It addresses public use of national park lands, and imposes no requirements on other agencies or governments. A statement containing the information required by the Unfunded Mandates Reform Act is not required.
This rule does not effect a taking of private property or otherwise have takings implications under Executive Order 12630. A takings implication assessment is not required.
Under the criteria in section 1 of Executive Order 13132, the rule does not have sufficient federalism implications to warrant the preparation of a Federalism summary impact statement. This proposed rule only affects use of federally-administered lands and waters. It has no outside effects on other areas. A Federalism summary impact statement is not required.
This rule complies with the requirements of Executive Order 12988. This rule:
(a) Meets the criteria of section 3(a) requiring that all regulations be reviewed to eliminate errors and ambiguity and be written to minimize litigation; and
(b) Meets the criteria of section 3(b)(2) requiring that all regulations be written in clear language and contain clear legal standards.
The Department of the Interior strives to strengthen its government-to-government relationship with Indian Tribes through a commitment to consultation with Indian Tribes and recognition of their right to self-governance and tribal sovereignty. The NPS has evaluated this rule under the criteria in Executive Order 13175 and under the Department's tribal consultation policy and has determined that tribal consultation is not required because the rule will not have a substantial direct effect on federally recognized Indian tribes, although consultation under the National Environmental Policy Act and the National Historic Preservation Act was completed. The NPS invited the Tribe to become a cooperating agency on the Draft Management Plan/Environmental Impact Statement (DEIS) on April 3,
This rule does not contain information collection requirements, and a submission to the Office of Management and Budget under the Paperwork Reduction Act is not required. The NPS may not conduct or sponsor and the public is not required to respond to a collection of information unless it displays a currently valid OMB control number.
This rule is part of a larger planning process for Saline Valley Warm Springs that constitutes a major Federal action significantly affecting the quality of the human environment. NPS has prepared the DEIS under the NEPA. A copy of the DEIS can be found online at
This rule is not a significant energy action under the definition in Executive Order 13211. A Statement of Energy Effects in not required.
The NPS is required by Executive Orders 12866 (section 1(b)(12)) and 12988 (section 3(b)(1)(B)), and 13563 (section 1(a)), and by the Presidential Memorandum of June 1, 1998, to write all rules in plain language. This means that each rule the NPS publishes must:
(a) Be logically organized;
(b) Use the active voice to address readers directly;
(c) Use common, everyday words and clear language rather than jargon;
(d) Be divided into short sections and sentences; and
(e) Use lists and tables wherever possible.
If you feel that the NPS has not met these requirements, send the NPS comments by one of the methods listed in the
It is the policy of the Department of the Interior, whenever practicable, to afford the public an opportunity to participate in the rulemaking process. Accordingly, interested persons may submit written comments regarding this proposed rule by one of the methods listed in the
Before including your address, phone number, email address, or other personal identifying information in your comment, you should be aware that your entire comment—including your personal identifying information—may be made publicly available at any time.
District of Columbia, National parks, Reporting and Recordkeeping requirements.
In consideration of the foregoing, the National Park Service proposes to amend 36 CFR part 7 as set forth below:
54 U.S.C. 100101, 100751, 320102; Sec. 7.96 also issued under DC Code 10-137 and DC Code 50-2201.07.
The revision and addition to read as follows:
(e) * * *
(3) Saline Valley Warm Springs Airfield, latitude N 36°48.41″, longitude W 117°46.90.
Federal Motor Carrier Safety Administration (FMCSA), DOT.
Announcement of public listening session.
The FMCSA announces that it will hold a public listening session concerning potential changes to its hours-of-service (HOS) rules for truck drivers. On August 23, 2018, FMCSA published an Advance Notice of Proposed Rulemaking (ANPRM) seeking public comment on four specific aspects of the HOS rules for which the Agency is considering changes: the short-haul HOS limit; the HOS exception for adverse driving conditions; the 30-minute rest break provision; and the sleeper berth rule to allow drivers to split their required time in the sleeper berth. In addition, the Agency requested public comment on petitions for rulemaking from the Owner-Operator Independent Drivers Association (OOIDA) and TruckerNation.org (TruckerNation). The Agency encourages vendors of electronic logging devices (ELDs) to participate to address potential implementation issues should changes to the HOS rules be made. The listening session is the third in a series and will be held at the National Automobile Museum in Reno, NV. The listening session will be webcast for the benefit of those not able to attend in person. The listening session will allow interested persons to present comments, views, and relevant research on topics mentioned above. All comments will be transcribed and placed in the rulemaking docket for the FMCSA's consideration.
The listening session will be Saturday, September 22, 2018, in Reno, NV.
The September 22, 2018, meeting will be held at the National Automobile Museum, 10 S. Lake Street, Reno, NV 89501. The listening session will begin at 10 a.m. (PDT) and end at 12 noon, or earlier, if all participants wishing to express their views have done so.
You may submit comments identified by Docket Number FMCSA-2018-0248 using any of the following methods:
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To avoid duplication, please use only one of these four methods. See the “Public Participation and Request for Comments” portion of the
For special accommodations for the HOS listening session, such as sign language interpretation, contact Mr. William Cunnane, Program Specialist, at (202) 366-0055 or
If you submit a comment, please include the docket number for this ANPRM (Docket No. FMCSA-2018-0248), indicate the specific section of this document to which each section applies, and provide a reason for each suggestion or recommendation. You may submit your comments and material online or by fax, mail, or hand delivery, but please use only one of these means. FMCSA recommends that you include your name and a mailing address, an email address, or a phone number in the body of your document so that FMCSA can contact you if there are questions regarding your submission.
To submit your comment online, go to
If you submit your comments by mail or hand delivery, submit them in an unbound format, no larger than 8
FMCSA will consider all comments and material received during the comment period for the ANPRM. Late comments will be considered to the extent practicable.
Confidential Business Information (CBI) is commercial or financial information that is customarily not made available to the public by the submitter. Under the Freedom of Information Act, CBI is eligible for protection from public disclosure. If you have CBI that is relevant or responsive to the ANPRM and this listening session, it is important that you clearly designate the submitted comments as CBI. Accordingly, please mark each page of your submission as “confidential” or “CBI.” Submissions designated as CBI and meeting the definition noted above will not be placed in the public docket for the ANPRM and this listening session. Submissions containing CBI should be sent to Mr. Brian Dahlin, Chief, Regulatory Analysis Division, 1200 New Jersey Avenue SE, Washington, DC 20590 or
FMCSA will consider all comments and material received during the comment period for the ANPRM.
To view comments, as well as any documents mentioned in this preamble as being available in the docket, go to
In accordance with 5 U.S.C. 553(c), DOT solicits comments from the public to better inform its rulemaking process. DOT posts these comments, without edit, including any personal information the commenter provides, to
On August 23, 2018 (83 FR 42631), FMCSA published an ANPRM concerning potential changes to its hours-of-service rules. The ANPRM indicated the Agency is considering changes in four areas of the HOS rules: The short-haul HOS limit [49 CFR 395.1(e)(1)(ii)(A)]; the HOS exception for adverse driving conditions [§ 395.1(b)(1)]; the 30-minute rest break provision [§ 395.3(a)(3)(ii)]; and the sleeper berth rule to allow drivers to split their required time in the sleeper berth [§ 395.1(g)(1)(i)(A) and (ii)(A)]. In addition, the Agency requested public comment on petitions for rulemaking from the Owner-Operator Independent Drivers Association (OOIDA) and TruckerNation.org (TruckerNation). The ANPRM provides an opportunity for additional discussion of each of these topics. The listening session will provide interested persons to share their views on these topics with representatives of the Agency. The Agency encourages ELD vendors to participate to address potential implementation issues should changes to the HOS rules be made.
The listening session is open to the public. Speakers' remarks will be limited to 2 minutes each. The public may submit material to the FMCSA staff at the session for inclusion in the public docket, FMCSA-2018-0248. The
In preparing their comments, meeting participants should consider the questions posed in the ANPRM about the current HOS requirements. Answers to these questions should be based upon the experience of the participants and any data or information they can share with FMCSA.
Advance notice of proposed rulemaking (ANPRM); Extension of comment period.
The Federal Motor Carrier Safety Administration (FMCSA) extends the comment period for its August 23, 2018, ANPRM concerning hours of service for drivers of property-carrying commercial motor vehicles (CMVs). FMCSA received requests for an extension to the comment period from a number of organizations, including the American Trucking Association, the Commercial Vehicle Safety Alliance, the International Brotherhood of Teamsters, the National Pork Producers Council, and the National Tank Truck Carriers, Inc. The Agency believes it is appropriate to extend the comment period to provide interested parties additional time to submit their responses to the ANPRM. Therefore, the Agency extends the deadline for the submission of comments from September 24, 2018, to October 10, 2018.
The comment period for the ANPRM published August 23, 2018 at 83 FR 42631 is extended. Comments on the ANPRM must be received on or before October 10, 2018.
You may submit comments identified by Docket Number FMCSA-2018-0248 using any one of the following methods:
To avoid duplication, please use only one of these four methods. See the “Public Participation and Request for Comments” heading under the
Mr. Tom Yager, Chief, Driver and Carrier Operations Division, Federal Motor Carrier Safety Administration, U.S. Department of Transportation, 1200 New Jersey Avenue SE, Washington, DC 20590, at (202) 366-4325, or via email:
If you have questions on viewing or submitting material to the docket, contact Docket Services, telephone (202) 366-9826.
FMCSA encourages you to participate by submitting comments and related materials.
If you submit a comment, please include the docket number for this notice (FMCSA-2018-0284), indicate the specific section of this document to which each comment applies, and provide a reason for each suggestion or recommendation. You may submit your comments and material online or by fax, mail, or hand delivery, but please use only one of these means. FMCSA recommends that you include your name and a mailing address, an email address, or a phone number in the body of your document so the Agency can contact you if it has questions regarding your submission.
To submit your comment online, go to
FMCSA will consider all comments and material received during the comment period and may change this proposed rule based on your comments. Late comments will be considered to the extent practicable.
Confidential Business Information (CBI) is commercial or financial information that is customarily not made available to the general public by the submitted. Under the Freedom of Information Act, CBI is eligible for protection from public disclosure. If you have CVI that is relevant or responsive to this notice, it is important that you clearly designate the submitted comments as CBI. Accordingly, please mark each page of your submission as “confidential” or “CBI.” Submissions designated as CBI and meeting the definition noted above will not be placed in the public docket. Submissions containing CBI should be sent to Brian Dahlin, Chief, Regulatory Evaluation Division, 1200 New Jersey Ave. SE, Washington, DC 20590. Any commentary that FMCSA receives which is not specifically designated as CBI will be placed in the public docket for this rulemaking.
To view comments, as well as documents available in the docket, go to
Under 5 U.S.C. 553(c), DOT solicits comments from the public to better inform its potential rulemaking process. DOT posts these comments, without edit, including any personal information the commenter provides, to
The August 23, 2018 ANPRM (83 FR 42631) asked for public comment on four subject areas: Short haul operations, adverse conditions, the 30-minute break, and the split-sleeper berth provision. The ANPRM also sought public comment on two petitions for rulemaking from the Owner-Operator Independent Drivers Association (OOIDA) and TruckerNation.
FMCSA held a public listening session on August 24, 2018, at the Great American Truck Show, in Dallas, Texas (83 FR 42630).
The comment period for the ANPRM was set to expire on September 24, 2018 (83 FR 42631). FMCSA received several requests to extend the comment period, as noted above. Copies of the requests are included in the docket referenced at the beginning of this notice.
The organizations requested various lengths of time for the extension ranging from 30 to 60 days, stating that the additional time was needed to enable them to prepare more comprehensive responses based on research and information that has only recently been released or is expected to be released at upcoming industry meetings.
FMCSA has determined that extending the comment period would provide the organizations additional time to prepare more detailed comments that are reflective of the concerns of their members. Accordingly, FMCSA extends the comment period for all comments on the ANPRM to October 10, 2018.
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Department of Commerce.
90-day petition finding, request for information, and initiation of status review.
We, NMFS, announce a 90-day finding on a petition to list the cauliflower coral (
Information and comments on the subject action must be received by November 19, 2018.
You may submit comments, information, or data on this document, identified by the code NOAA-NMFS-2018-0060, by either of the following methods:
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Copies of the petition and related materials are available on our website at
Lance Smith, NMFS, Pacific Islands Regional Office, Protected Resources Division, (808) 725-5131; or Chelsey Young, NMFS, Office of Protected Resources, 301-427-8403.
On March 14, 2018, we received a petition from the Center for Biological Diversity to list the cauliflower coral (
Section 4(b)(3)(A) of the ESA of 1973, as amended (16 U.S.C. 1531
ESA-implementing regulations issued jointly by NMFS and USFWS (50 CFR 424.14(h)(1)(i)) define “substantial scientific or commercial information” in the context of reviewing a petition to list, delist, or reclassify a species as credible scientific or commercial information in support of the petition's claims such that a reasonable person conducting an impartial scientific review would conclude that the action proposed in the petition may be warranted. Conclusions drawn in the petition without the support of credible scientific or commercial information will not be considered “substantial information.” In evaluating whether substantial information is contained in the petition, we consider whether the petition (1) Clearly indicates the administrative measure recommended and gives the scientific and any common name of the species involved; (2) contains a detailed narrative justification for the recommended measure, describing, based on available information, past and present numbers and distribution of the species involved and any threats faced by the species; (3) provides information regarding the status of the species over all or a significant portion of its range; and (4) is accompanied by the appropriate supporting documentation in the form of bibliographic references, reprints of pertinent publications, copies of reports or letters from authorities, and maps (50 CFR 424.14(b)(2)).
Under the ESA, a listing determination addresses the status of a species, which is defined to also include subspecies and, for any vertebrate species, any distinct population segment (DPS) that interbreeds when mature (16 U.S.C. 1532(16)). Because
At the 90-day finding stage, we evaluate the petitioners' request based upon the information in the petition including its references and the information readily available in our files. We do not conduct additional research, and we do not solicit information from parties outside the agency to help us in evaluating the petition. We are not required to consider any supporting materials cited by the petitioner if the petitioner does not provide electronic or hard copies, to the extent permitted by U.S. copyright law, or appropriate excerpts or quotations from those materials (
Our determination as to whether the petition provides substantial scientific or commercial information indicating that the petitioned action may be warranted depends in part on the degree to which the petition includes the following types of information: (1) Information on current population status and trends and estimates of current population sizes and distributions, both in captivity and the wild, if available; (2) identification of the factors under section 4(a)(1) of the ESA that may affect the species and where these factors are acting upon the species; (3) whether and to what extent any or all of the factors alone or in combination identified in section 4(a)(1) of the ESA may cause the species to be an endangered species or threatened species (
The factors under section 4(a)(1) of the ESA that may affect the species are as follows: (1) The present or threatened destruction, modification, or curtailment of habitat or range; (2) overutilization for commercial, recreational, scientific, or educational purposes; (3) disease or predation; (4) inadequacy of existing regulatory mechanisms to address identified threats; rand (5) any other natural or manmade factors affecting the species' existence (16 U.S.C. 1533(a)(1), 50 CFR 424.11(c)). Information presented on these factors should be specific to the species and should reasonably suggest that one or more of these factors may be operative threats that act or have acted on the species to the point that it may
As described in the final rule to list 20 species of coral under the ESA (79 FR 53851; September 10, 2014), the morphology-based taxonomy of the genus
These studies demonstrate that colony morphology in pocilloporids is a poor indicator of taxonomic relationships for the following reasons: (1) Morphologically similar colonies may not be the same species (
Other recent papers on genetic or morphological aspects of
Despite doubt raised by traditional morphology-based taxonomy, other readily available information in our files presents substantial scientific or commercial information indicating that
While such competitive reef coral species typically dominate ideal environments, they also have higher susceptibility to threats such as elevated seawater temperatures than reef coral species with generalist, weedy, or stress-tolerant life histories (Darling
The species has several other characteristics that may also provide buffering against some threats, including the capacity for acclimatization and adaptation to changing conditions, the potential for range expansion as previously unsuitable habitat becomes suitable, and a broad range that encompasses extensive habitat heterogeneity. The bleaching and mortality of some colonies of a coral species on a reef, followed by the recovery of hardier colonies, is the process by which acclimatization and adaptation of a species to ocean warming occurs, and has been documented in some
Although there is little species-specific, range-wide data on
It is likely that
Although the petition presents information on at least four of the five ESA factors in section 4(a)(1) of the ESA (
Information presented in the petition and other readily available information in our files indicate that the most important threat to
(1)
IPCC (2013) was based on data collected through 2010, but overall global warming (oceans and land combined) and ocean warming have both continued at an even greater pace since then. Global temperatures (ocean and land combined) in 2015 and 2016 were the warmest since instrumental record keeping began in the 19th century (NASA, 2016). Ocean warming has continued, and there was more ocean warming in 2014-2016 than any previous three-year period on record (Jewett and Romanou, 2017). There is consensus among several different methods of monitoring seawater temperatures that ocean warming has continued unabated since 2010 both globally and regionally in all of the world's oceans (Gleckler
(2)
The climate change projections, including for ocean warming, ocean acidification, and sea level rise, in the 2014 coral final listing rule were based on RCP8.5 in IPCC's AR5 (IPCC, 2013). RCP8.5 assumes a continued
RCP8.5 projects that global annual mean ocean surface temperatures will increase from 2013 levels by approximately 0.4-1.0°C by 2030, approximately 0.7-2.0°C by 2060, and approximately 2.0-5.0°C by 2100, further exacerbating the impacts of ocean warming on corals and coral reefs. In the Indo-Pacific, projected changes in annual median ocean surface temperatures under RCP8.5 will increase from 2013 levels by approximately 0.0-1.0°C by 2035, 1.0-3.0°C by 2065, and 2.0-5.0°C by 2100. Spatial variability in the projections consists mostly of larger increases in the Red Sea, Persian Gulf, and the Coral Triangle, and lower increases in the central and eastern Indian Ocean and south-central Pacific. The percent ranges in the projections described above are for the 25 to 75 percent range confidence intervals, however the range of projections within the 5 to 95 percent range confidence intervals are considerably greater (IPCC, 2013). As described in detail in the RCP8.5 Projections section of the 2014 coral final listing rule, these global mean projections are not necessarily representative of ocean surface temperature conditions throughout the ranges and habitats of reef corals in the future, due both to spatial variability and to statistical range of the RCP8.5 ocean warming projections (79 FR 53851; September 10, 2014).
(3)
Warming-induced coral bleaching occurs when elevated seawater temperatures cause the expulsion of the host coral's symbiotic zooxanthellae in response to thermal stress. While mild to moderate bleaching does not necessary cause coral mortality, repeated or prolonged bleaching can lead to colony mortality. Many coral physiological processes are optimized to the local long-term seasonal and interannual variations in seawater temperature experienced by the corals, and an increase of only 1°C-2°C above the normal local seasonal maximum can induce bleaching. Bleaching is best predicted by using an index of accumulated thermal stress above a locally established threshold (Brainard
According to the information in the petition and other readily available information in our files, warming-induced bleaching and mortality have impacted
The 2016 warming-induced bleaching event across the Indo-Pacific was the worst in recorded history in terms of severity and duration of elevated seawater temperatures and ensuing mass coral bleaching and mortality (Lough
Although difficulty in identification of
(4)
Projections of the responses of the world's corals and coral reefs ecosystems to ocean warming have been addressed recently by several papers that project coral responses to one or more of the IPCC's four pathways in the future. An analysis of the likely reef coral disease outbreaks resulting from ocean warming projected by RCP4.5 and RCP8.5 concluded that both pathways are likely to cause sharply increased, but spatially highly variable, levels of coral disease in the future, and that the outbreaks would be more widespread, frequent, and severe under RCP8.5 than RCP4.5 (Maynard
All five analyses considered the impacts of one or both of the IPCC's lower emissions pathways (RCP2.6 and RCP4.5), and each analysis reached the same conclusion: Even these lower emissions pathways are likely to have more severe impacts to reef corals in the future than have been observed in recent years (Hoegh-Guldberg
After reviewing the information presented in the petition and other readily available information in our files, we find that listing
To ensure that the status review is based on the best available scientific and commercial data, we are soliciting information on whether
(1) Historical and current distribution and abundance of
(2) Historical and current condition of
(3) Population density and trends of
(4) The effects of climate change, including ocean warming and acidification, on the distribution and condition of
(5) The effects of other threats including dredging; coastal development; land-based sources of pollution, including coastal point source pollution, and agricultural and land use practices; disease, predation, the trophic effects of fishing, the aquarium trade, physical damage from boats and anchors, marine debris, aquatic invasive species on the distribution and abundance of
(6) Management programs for conservation of
We request that all information be accompanied by (1) supporting documentation such as maps, bibliographic references, or reprints of pertinent publications; and (2) the submitter's name, address, and any association, institution, or business that the person represents.
A complete list of references upon request from Lance Smith, NOAA IRC, NMFS/PIRO/PRD, 1845 Wasp Blvd., Bldg. 176, Honolulu, HI 96818.
The authority for this action is the Endangered Species Act of 1973, as amended (16 U.S.C. 1531
National Marine Fisheries Service (NMFS), National Oceanic and
Proposed rule; extension of comment period.
NMFS previously published, on July 27, 2018, a proposed rule to amend the 2006 Consolidated Atlantic Highly Migratory Species (HMS) Fishery Management Plan (FMP) based on the results of the 2017 stock assessment and a subsequent binding recommendation by the International Commission for the Conservation of Atlantic Tunas (ICCAT) for North Atlantic shortfin mako sharks. The comment period on the proposed rule ends on October 1, 2018. In this extension of comment period, NMFS is extending the comment period to October 8, 2018, to provide an opportunity for the South Atlantic Fishery Management Council (Council) to be briefed, and to provide additional opportunities for the Council and other interested parties to comment on the proposed rule.
The deadline for receipt of comments on the proposed rule published on July 27, 2018 (83 FR 35637) is extended from October 1, 2018 to October 8, 2018.
You may submit comments on the referenced proposed rule published on July 27, 2018 (83 FR 35637), identified by NOAA-NMFS-2018-0011, by any one of the following methods:
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Guý DuBeck or Karyl Brewster-Geisz at (301) 427-8503.
The North Atlantic shortfin mako stock is managed primarily under the authority of the Magnuson-Stevens Act and also under the Atlantic Tunas Convention Act (ATCA). The 2006 Consolidated HMS FMP and its amendments are implemented by regulations at 50 CFR part 635.
On July 27, 2018 (83 FR 35637), NMFS published a proposed rule that announced NMFS' intent to amend the 2006 Consolidated Atlantic HMS FMP based on the results of the 2017 stock assessment and a subsequent binding recommendation by the International Commission for the Conservation of Atlantic Tunas (ICCAT) for North Atlantic shortfin mako sharks. The North Atlantic shortfin mako shark stock is overfished and is experiencing overfishing. Consistent with the Magnuson-Stevens Fishery Conservation and Management Act (Magnuson-Stevens Act) and the Atlantic Tunas Convention Act (ATCA), NMFS is proposing management measures that would reduce fishing mortality on shortfin mako sharks and establish a foundation for rebuilding the shortfin mako shark population consistent with legal requirements. In the proposed rule, the end of the comment period was announced as October 1, 2018. However, due to Hurricane Florence, the South Atlantic Fishery Management Council postponed its previously scheduled meeting by several weeks. Without an extension of the comment period, the Council would be unable to receive the same briefing provided to other Councils prior to providing comments on Amendment 11. As such, NMFS is extending the comment period to provide an opportunity to be briefed and an additional opportunity for the South Atlantic Fishery Management Council and other interested parties to comment on the proposed rule. Therefore, the comment period for the proposed rule is extended to October 8, 2018.
16 U.S.C. 971
Research, Education, and Economics, USDA.
Notice of public meeting.
In accordance with the Federal Advisory Committee Act, 5 U.S.C. App 2, Section 1408 of the National Agricultural Research, Extension, and Teaching Policy Act of 1977 (7 U.S.C. 3123), and the Agricultural Act of 2014, the United States Department of Agriculture (USDA) announces a virtual meeting of the National Agricultural Research, Extension, Education, and Economics Advisory Board.
The National Agricultural Research Extension, Education, and Economics Advisory Board will meet virtually by telephone conference on September 28, 2018, from 11:30 a.m.-1:00 p.m. Eastern Daylight Time (EDT). The public may file written comments before or up to October 12, 2018.
The meeting will take place virtually via teleconference.
Web Preregistration: Participants wishing to participate may preregister by calling 202-720-6012 or email at
Written comments may be sent to: The National Agricultural Research, Extension, Education, and Economics Advisory Board Office, Room 332A, Whitten Building, United States Department of Agriculture, 1400 Independence Avenue SW, Washington, DC 20250-0321.
Michele Esch, Executive Director/Designated Federal Official, or Shirley Morgan-Jordan, Program Support Coordinator, National Agricultural Research, Extension, Education, and Economics Advisory Board; telephone: (202) 720-3684; fax: (202)720-6199; or email:
Animal and Plant Health Inspection Service, USDA.
Revision to and extension of approval of an information collection; comment request.
In accordance with the Paperwork Reduction Act of 1995, this notice announces the Animal and Plant Health Inspection Service's intention to request a revision to and extension of approval of an information collection associated with the regulations for the importation of fresh peppers from Peru into the continental United States and the Territories.
We will consider all comments that we receive on or before November 19, 2018.
You may submit comments by either of the following methods:
•
•
Supporting documents and any comments we receive on this docket may be viewed at
For information on the importation of fresh peppers from Peru into the continental United States and the Territories, contact Ms. Claudia Ferguson, Senior Regulatory Policy Coordinator, PPQ, APHIS, 4700 River Road Unit 39, Riverdale, MD 20737; (301) 851-2532. For more detailed information on the information collection, contact Ms. Kimberly Hardy, APHIS' Information Collection Coordinator, at (301) 851-2483.
The regulations in § 319.56-73 allow the importation of fresh peppers into the continental United States and the Territories from Peru. As a condition of entry, the peppers have to be produced in accordance with a systems approach that includes requirements for operational workplans, quality control programs, fruit fly trapping, pre-harvest production site inspections, production site and packinghouse registration, emergency action notifications, notices of arrival for imports, and packinghouse procedures designed to exclude quarantine pests. The peppers are also required to be imported in commercial consignments and accompanied by a phytosanitary certificate issued by the national plant protection organization (NPPO) of Peru with an additional declaration stating that the consignment was produced in accordance with the systems approach outlined in the regulations. These actions allow for the importation of fresh peppers from Peru while continuing to provide protection against the introduction of plant pests into the United States and the Territories.
We are asking the Office of Management and Budget (OMB) to approve our use of these information collection activities, as described, for an additional 3 years.
The purpose of this notice is to solicit comments from the public (as well as affected agencies) concerning our information collection. These comments will help us:
(1) Evaluate whether the collection of information is necessary for the proper performance of the functions of the Agency, including whether the information will have practical utility;
(2) Evaluate the accuracy of our estimate of the burden of the collection of information, including the validity of the methodology and assumptions used;
(3) Enhance the quality, utility, and clarity of the information to be collected; and
(4) Minimize the burden of the collection of information on those who are to respond, through use, as appropriate, of automated, electronic, mechanical, and other collection technologies;
All responses to this notice will be summarized and included in the request for OMB approval. All comments will also become a matter of public record.
U.S. Codex Office, USDA.
Notice of public meeting and request for comments.
The U.S Codex Program is sponsoring a public meeting on Tuesday, November 6, 2018. The objective of the public meeting is to provide information and receive public comments on agenda items and draft United States (U.S.) positions to be discussed at the 40th session of the Codex Committee on Nutrition and Foods for Special Dietary Uses (CCNFSDU) of the Codex Alimentarius Commission in Berlin, Germany November 26-30, 2018. The U.S. Manager for Codex Alimentarius and the Under Secretary, Office of Trade and Foreign Agricultural Affairs, recognize the importance of providing interested parties the opportunity to obtain background information on the 40th Session of the CCNFSDU and to address items on the agenda.
The public meeting is scheduled for Tuesday, November 6, 2018 from 1:00 p.m. to 3:00 p.m.
The public meeting will take place at the Food and Drug Administration (FDA) Center for Food Safety and Applied Nutrition, Wiley Building, Room 1A002, 55 Campus Drive, College Park, MD 20740.
Documents related to the 40th Session of the CCNFSDU will be accessible via the internet at the following address:
Dr. Douglas Balentine, U.S. Delegate to the 40th Session of the CCNFSDU, invites U.S. interested parties to submit their comments electronically to the following email address:
Call-In-Number: If you wish to participate in the public meeting for the 40th Session of the CCNFSDU by conference call, please use the call-in-number listed below:
Call-In-Number: 1-877-465-7975—U.S. Toll Free.
The participant code will be posted on the web page below:
About the 40th Session Of the CCNFSDU: Doug Balentine, Director, Office of Nutrition and Food Labelling, Center for Food Safety and Applied Nutrition, U.S. Food and Drug Administration, 5001 Campus Drive (HFS-830), College Park, MD 20740. Phone: +1 240 402 2373. Fax: +1 (301) 436-2636. Email:
About the Public Meeting: Doreen Chen-Moulec, U.S. Codex Office, 1400 Independence Avenue SW, Room 4861, South Agriculture Building, Washington, DC 20250, Phone: (202) 720-4063, Fax: (202) 720-3157, Email:
Attendees may register to attend the public meeting by emailing
Early registration is encouraged because it will expedite entry into the building. The meeting will take place in a Federal building. Attendees should bring photo identification and plan for adequate time to pass through the security screening systems. Attendees who are not able to attend the meeting in person, but who wish to participate, may do so by phone, as discussed above.
Codex was established in 1963 by two United Nations organizations, the Food and Agriculture Organization (FAO) and the World Health Organization (WHO). Through adoption of food standards, codes of practice, and other guidelines developed by its committees, and by promoting their adoption and implementation by governments, Codex seeks to protect the health of consumers and ensure fair practices in the food trade.
The CCNFSDU is responsible for:
(a) Studying nutrition issues referred to it by the Codex Alimentarius Commission;
(b) Drafting general provisions, as appropriate, on nutritional aspects of all foods and developing standards, guidelines, and related texts for foods for special dietary uses, in cooperation with other committees where necessary; and
(c) Considering, amending if necessary, and endorsing provisions on nutritional aspects proposed for inclusion in Codex standards, guidelines, and related texts.
The CCNFSDU is hosted by Germany. The U.S. attends CCNFSDU as a member country of Codex.
The following items on the Agenda for the 40th Session of the CCNFSDU will be discussed during the public meeting:
Each issue listed will be fully described in documents distributed, or to be distributed by the Secretariat before the Committee meeting. Members of the public may access or request copies of these documents (see
At the Tuesday, November 6, 2018 public meeting, draft U.S. positions on the agenda items will be described and discussed, and attendees will have the opportunity to pose questions and offer comments. Written comments may be offered at the meeting or sent to Douglas Balentine, U.S. Delegate for the 40th Session of the CCNFSDU (see
Public awareness of all segments of rulemaking and policy development is important. Consequently, the U.S. Codex Office will announce this
No agency, officer, or employee of the USDA shall, on the grounds of race, color, national origin, religion, sex, gender identity, sexual orientation, disability, age, marital status, family/parental status, income derived from a public assistance program, or political beliefs, exclude from participation in, deny the benefits of, or subject to discrimination any person in the United States under any program or activity conducted by the USDA.
To file a complaint of discrimination, complete the USDA Program Discrimination Complaint Form, which may be accessed online at
Send your completed complaint form or letter to USDA by mail, fax, or email. Mail: U.S. Department of Agriculture, Director, Office of Adjudication, 1400 Independence Avenue SW, Washington, DC 20250-9410.
Persons with disabilities who require alternative means for communication (Braille, large print, audiotape, etc.) should contact USDA's TARGET Center at (202) 720-2600 (voice and TDD).
U.S. Codex Office, USDA.
Notice of public meeting and request for comments.
The U.S Codex Office is sponsoring a public meeting on October 9, 2018. The objective of the public meeting is to provide information and receive public comments on agenda items and draft United States (U.S.) positions to be discussed at the 50th session of the Codex Committee on Food Hygiene (CCFH) of the Codex Alimentarius Commission in Panama City, Panama on November 12—16, 2018. The U.S. Manager for Codex Alimentarius and the Under Secretary, Office of Trade and Foreign Agricultural Affairs, recognize the importance of providing interested parties the opportunity to obtain background information on the 50th Session of the CCFH and to address items on the agenda.
The public meeting is scheduled for Tuesday, October 9, 2018 from 1:00 p.m. to 4 p.m.
The public meeting will take place at the United States Department of Agriculture (USDA), Jamie L. Whitten Building, 1400 Independence Avenue SW, Room 107-A, Washington, DC 20250. Documents related to the 50th Session of the CCFH will be accessible via the internet at the following address:
Jenny Scott, U.S. Delegate to the 50th Session of the CCFH, invites U.S. interested parties to submit their comments electronically to the following email address:
Call-In-Number: If you wish to participate in the public meeting for the 50th Session of the CCFH by conference call, please use the call-in-number listed below:
Call-In-Number: 1-888-844-9904.
The participant code will be posted on the web page below:
About the 50th Session Of The CCFH: Jenny Scott, Senior Advisor, Office of Food Safety, Center for Food Safety and Applied Nutrition, U.S. Food and Drug Administration, 5001 Campus Drive HFS-300, Room 3B-014. College Park, MD 20740-3835 Phone: +1 (240) 402-2166. Fax: +1 (301) 436-2632. Email:
About the Public Meeting: Barbara McNiff, U.S. Codex Office, 1400 Independence Avenue SW, Room 4861, South Agriculture Building, Washington, DC 20250 Phone: (202) 690-4719, Fax: (202) 720-3157, Email:
Attendees may register to attend the public meeting by emailing
Codex was established in 1963 by two United Nations organizations, the Food and Agriculture Organization (FAO) and the World Health Organization (WHO). Through adoption of food standards, codes of practice, and other guidelines developed by its committees, and by promoting their adoption and implementation by governments, Codex seeks to protect the health of consumers and ensure fair practices in the food trade.
The CCFH is responsible for:
• Developing basic provisions on food hygiene, applicable to all food or to specific food types;
• Considering and amending or endorsing provisions on food hygiene contained in Codex commodity standards and codes of practice developed by Codex commodity committees;
• Considering specific food hygiene problems assigned to it by the Commission;
• Suggesting and prioritizing areas where there is a need for microbiological risk assessment at the international level and developing questions to be addressed by the risk assessors; and
• Considering microbiological risk management matters in relation to food hygiene and in relation to the FAO/WHO risk assessments.
The CCFH is hosted by the United States. The 50th Session will be co-hosted by Panama and will convene in Panama City.
The following items on the Agenda for the 50th Session of the CCFH will be discussed during the public meeting:
Each issue listed will be fully described in documents distributed, or to be distributed by the Secretariat before the Committee meeting. Members of the public may access or request copies of these documents (see
At the October 9 public meeting, draft U.S. positions on the agenda items will be described and discussed, and attendees will have the opportunity to pose questions and offer comments. Written comments may be offered at the
Public awareness of all segments of rulemaking and policy development is important. Consequently, the U.S. Codex Office will announce this
No agency, officer, or employee of the USDA shall, on the grounds of race, color, national origin, religion, sex, gender identity, sexual orientation, disability, age, marital status, family/parental status, income derived from a public assistance program, or political beliefs, exclude from participation in, deny the benefits of, or subject to discrimination any person in the United States under any program or activity conducted by the USDA.
To file a complaint of discrimination, complete the USDA Program Discrimination Complaint Form, which may be accessed online at
Send your completed complaint form or letter to USDA by mail, fax, or email.
Mail: U.S. Department of Agriculture, Director, Office of Adjudication, 1400 Independence Avenue SW, Washington, DC 20250-9410.
Fax: (202) 690-7442, Email:
Persons with disabilities who require alternative means for communication (Braille, large print, audiotape, etc.) should contact USDA's TARGET Center at (202) 720-2600 (voice and TDD).
Commission on Civil Rights.
Announcement of bi-monthly planning meeting.
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 a meeting of the Colorado Advisory Committee to the Commission will convene by conference call and video conference at 2:00 p.m. (EDT) on Friday, October 5, 2018. The purpose of the meeting is to plan for project planning.
Friday, October 5, 2018, at 2:00 p.m. (EDT).
If you have difficulty with the video link, try a browser other than Explorer or contact ReadyTalk Technical Support at: 1-800-843-9166. Note: Upon receipt of your registration confirmation email, you will receive a link to test your computer before the meeting, it would be advisable to do so.
Evelyn Bohor,
Interested members of the public may listen to the discussion by calling the following toll-free conference call number: 1-888-395-3237 and conference call ID: 1659256; video conference link:
Please be advised that, before being placed into the conference call, the conference call operator will ask callers to provide their names, their organizational affiliations (if any), and email addresses (so that callers may be notified of future meetings). Callers can expect to incur charges for calls they initiate over wireless lines, and the Commission will not refund any incurred charges. Callers will incur no charge for calls they initiate over land-line connections to the toll-free telephone number provided.
Persons with hearing impairments may also follow the discussion by first calling the Federal Relay Service at 1-800-877-8339 and providing the operator with the toll-free conference call number: 1-888-395-3237 and conference call 1659256.
Members of the public are invited to make statements during the open comment period of the meeting or submit written comments. The comments must be received in the regional office approximately 30 days after each scheduled meeting. Written comments may be mailed to the Rocky Mountain Regional Office, U.S. Commission on Civil Rights, 1961 Stout Street, Suite 13-201, Denver, CO 80294, faxed to (303) 866-1040, or emailed to Evelyn Bohor at
Records and documents discussed during the meeting will be available for public viewing as they become available at
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Notice of public meetings.
The Pacific Fishery Management Council's (Pacific Council) Ad Hoc Sablefish Management and Trawl Allocation Attainment Committee (SaMTAAC) will hold a meeting.
The meeting will be held Wednesday, October 10, 2018 and Thursday, October 11, 2018, starting at 8 a.m. and will end when business for the day has been completed.
The meeting will be held at the Hyatt Place Portland Airport, Meeting Place #3, 9750 NE Cascade Station, Portland, OR 97220; telephone: (503) 288-2808.
Dr. Jim Seger, Pacific Council; telephone: (503) 820-2416.
At this meeting, the SaMTAAC will continue to develop alternatives that address obstacles to achieving the goals and objectives of the groundfish trawl catch share plan related to under attainment of non-sablefish shore based trawl allocations and unharvested sablefish quota pounds south of 36° N. latitude. The committee's initial work on alternatives will be presented at the November 2018 Council meeting to solicit further Council guidance.
Although non-emergency issues not contained in the meeting agenda may be discussed, those issues may not be the subject of formal action during this meeting. Action will be restricted to those issues specifically listed in this document and any issues arising after publication of this document that require emergency action under section 305(c) of the Magnuson-Stevens Fishery Conservation and Management Act, provided the public has been notified of the intent to take final action to address the emergency.
The meeting is physically accessible to people with disabilities. Requests for sign language interpretation or other auxiliary aids should be directed to Mr. Kris Kleinschmidt (
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce
Notice; public meeting.
The New England Fishery Management Council (Council) is scheduling a public meeting of its Scientific & Statistical Committee to consider actions affecting New England fisheries in the exclusive economic zone (EEZ). Recommendations from this group will be brought to the full Council for formal consideration and action, if appropriate.
This meeting will be held on Wednesday, October 10, 2018 beginning at 9 a.m.
Thomas A. Nies, Executive Director, New England Fishery Management Council; telephone: (978) 465-0492.
The Scientific and Statistical Committee will review the results of the recent benchmark stock assessment (SAW/SARC 65) and information provided by the Council's Scallop Plan Development Team (PDT). The Committee will recommend the overfishing levels (OFLs) and acceptable biological catches (ABCs) for Atlantic sea scallops for fishing years 2019-20 (default). They will also review information provided by the Council's Herring PDT, the results from recent Atlantic herring benchmark stock assessment and using the acceptable biological catch (ABC) control rule selected by the Council, recommend the overfishing level (OFL) and the ABCs for Atlantic herring for 2019-21. Other business will be discussed as needed.
Although non-emergency issues not contained in this agenda may come before this group for discussion, those issues may not be the subject of formal action during these meetings. Action will be restricted to those issues specifically listed in this notice and any issues arising after publication of this notice that require emergency action under section 305(c) of the Magnuson-Stevens Act, provided the public has been notified of the Council's intent to take final action to address the emergency. The public also should be aware that the meeting will be recorded. Consistent with 16 U.S.C. 1852, a copy of the recording is available upon request.
This meeting is physically accessible to people with disabilities. Requests for sign language interpretation or other auxiliary aids should be directed to Thomas A. Nies, Executive Director, at (978) 465-0492, at least 5 days prior to the meeting date.
16 U.S.C. 1801
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Notice of a public meeting; via webinar.
The Gulf of Mexico Fishery Management Council will hold a meeting of its Mackerel Advisory Panel via webinar.
The webinar will convene on Tuesday, October 9, 2018, 1 p.m. to 3 p.m., EDT.
Ryan Rindone, Fishery Biologist, Gulf of Mexico Fishery Management Council;
The meeting will held via webinar. You may register for the webinar by visiting
The Agenda is subject to change, and the latest version along with other meeting materials will be posted on
Although other non-emergency issues not on the agenda may come before the Advisory Panel for discussion, in accordance with the Magnuson-Stevens Fishery Conservation and Management Act, those issues may not be the subject of formal action during this meeting. Actions of the Advisory Panel will be restricted to those issues specifically identified in the agenda and any issues arising after publication of this notice that require emergency action under section 305(c) of the Magnuson-Stevens Fishery Conservation and Management Act, provided the public has been notified of the Council's intent to take action to address the emergency.
This meeting is physically accessible to people with disabilities. Requests for sign language interpretation or other auxiliary aids should be directed to Kathy Pereira at the Gulf Council Office (see
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Notice; receipt of application.
Notice is hereby given that Point Blue Conservation Science, has applied in due form for a permit to conduct research on pinnipeds in California.
Written, telefaxed, or email comments must be received on or before October 22, 2018.
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 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 Shasta McClenahan, (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 proposed permit would authorize research to study and monitor population trends, health, and ecology of pinnipeds in California. Each year, up to 2,210 Northern elephant seals (
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; issuance of permits.
Notice is hereby given that permits or permit amendments have been issued to the following entities under the Marine Mammal Protection Act (MMPA) and the Endangered Species Act (ESA), as applicable.
The permits and related documents are available for review 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.
Amy Hapeman (Permit No. 21233), Erin Markin (Permit No. 20561), and Carrie Hubard (Permit No. 22292); at (301) 427-8401.
Notices were published in the
In compliance with the National Environmental Policy Act of 1969 (42 U.S.C. 4321
As required by the ESA, as applicable, issuance of these permit was based on a finding that such permits: (1) Were applied for in good faith; (2) will not operate to the disadvantage of such endangered species; and (3) are consistent with the purposes and policies set forth in Section 2 of the ESA.
The requested permits have been issued under the Marine Mammal Protection Act of 1972, as amended (16 U.S.C. 1361
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Department of Commerce.
Notice of open public meeting.
This notice sets forth the proposed schedule and agenda of a forthcoming meeting of the Marine Fisheries Advisory Committee's (MAFAC's) Columbia Basin Partnership Task Force (CBP Task Force). The CBP Task Force will discuss the issues outlined in the
The meeting will be held October 2, 2018, from 8 a.m. to 5 p.m. and on October 3, 2018, from 8 a.m. to 4 p.m.
The meeting will be held at the Port of Portland, 7200 NE Airport Way, Portland, OR 97218; 503-415-6000.
Katherine Cheney; NFMS West Coast Region; 503-231-6730; email:
Notice is hereby given of a meeting of MAFAC's CBP Task Force. The MAFAC was established by the Secretary of Commerce (Secretary) and, since 1971, advises the Secretary on all living marine resource matters that are the responsibility of the Department of Commerce. The MAFAC charter and meeting information are located online at
The meeting time and agenda are subject to change. Meeting topics include continuing to seek agreement on qualitative and quantitative goals for Columbia Basin salmon and steelhead, discussing approaches to integrate the information towards developing basin-wide goals, and working on the draft recommendations report. The meeting is open to the public as observers, and public input will be accepted on October 3, 2018, from 1:30 to 2 p.m.
The meeting is physically accessible to people with disabilities. Requests for sign language interpretation or other auxiliary aids should be directed to Katherine Cheney, 503-231-6730, by September 25, 2018.
Commodity Futures Trading Commission.
Notice of meeting.
The Commodity Futures Trading Commission (CFTC) announces that on October 5, 2018, from 10:00 a.m. to 3:30 p.m., the Technology Advisory Committee (TAC) will hold a public meeting in the Conference Center at the CFTC's Washington, DC, headquarters. At this meeting, the TAC will hear presentations and actionable recommendations from select TAC subcommittees (potentially including Automated and Modern Trading Markets; Distributed Ledger Technology and Market Infrastructure; Virtual Currencies; and Cyber Security subcommittees); and discuss how RegTech is opening up the possibility of machine readable and executable regulatory rulebooks (
The meeting will be held on October 5, 2018, from 10:00 a.m. to 3:30 p.m. Members of the public who wish to submit written statements in connection with the meeting should submit them by October 12, 2018.
The meeting will take place in the Conference Center at the CFTC's headquarters, Three Lafayette Centre, 1155 21st Street NW, Washington, DC 20581. You may submit public comments, identified by “Technology Advisory Committee,” by any of the following methods:
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•
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Any statements submitted in connection with the committee meeting will be made available to the public, including publication on the CFTC website,
Daniel Gorfine, TAC Designated Federal Officer, Commodity Futures Trading Commission, Three Lafayette Centre, 1155 21st Street NW, Washington, DC 20581; (202) 418-5625.
The meeting will be open to the public with seating on a first-come, first-served basis. Members of the public may also listen to the meeting by telephone by calling a domestic toll-free telephone or international toll or toll-free number to connect to a live, listen-only audio feed. Call-in participants should be prepared to provide their first name, last name, and affiliation.
The meeting agenda may change to accommodate other TAC priorities. For agenda updates, please visit the TAC committee site at:
After the meeting, a transcript of the meeting will be published through a link on the CFTC's website,
5 U.S.C. app. 2, sec. 10(a)(2).
10:00 a.m., Wednesday, September 26, 2018.
Three Lafayette Centre, 1155 21st Street NW, Washington, DC, 9th Floor Commission Conference Room.
Closed.
Examinations and enforcement matters. In the event that the time, date, or location of this meeting changes, an announcement of the change, along with the new time, date, and/or place of the meeting will be posted on the Commission's website at
Christopher Kirkpatrick, 202-418-5964.
Commodity Futures Trading Commission.
Notice.
In compliance with the Paperwork Reduction Act of 1995 (PRA), this notice announces that the Information Collection Request (ICR) abstracted below has been forwarded to the Office of Management and Budget (OMB) for review and comment. The ICR describes the nature of the information collection and its expected costs and burden.
Comments must be submitted on or before October 22, 2018.
Comments regarding the burden estimated or any other aspect of the information collection, including suggestions for reducing the burden, may be submitted directly to the Office of Information and Regulatory Affairs (OIRA), in OMB, within 30 days of this notice's publication by either of the following methods. Please identify the comments by “OMB Control No. 3038-97.
•
•
A copy of all comments submitted to OIRA should be sent to the Commodity Futures Trading Commission (the “Commission”) by any of the following methods. The copies should refer to “OMB Control No. 3038-0097.”
•
• By Hand Delivery/Courier to the same address; or
• Through the Commission's website at
A copy of the supporting statement for the collection of information discussed herein may be obtained by visiting
All comments must be submitted in English, or if not, accompanied by an English translation. Comments will be posted as received to
Megan Wallace, Senior Special Counsel, Division of Clearing and Risk, Commodity Futures Trading Commission, (202) 418-5150; email:
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. On July 6, 2018, the Commission published in the
44 U.S.C. 3501
Wednesday, September 26, 2018, 10:00 a.m.-12:00 p.m.
Hearing Room 420, Bethesda Towers, 4330 East West Highway, Bethesda, MD.
Commission Meeting—Open to the Public.
Briefing Matter: Fiscal Year 2019 Operating Plan.
A live webcast of the Meeting can be viewed at
Rockelle Hammond, Office of the Secretariat, Office of the General Counsel, U.S. Consumer Product Safety Commission, 4330 East West Highway, Bethesda, MD 20814, (301) 504-6833.
Department of the Army, DoD.
Information collection notice.
In compliance with the
Consideration will be given to all comments received by November 19, 2018.
You may submit comments, identified by docket number and title, by any of the following methods:
To request more information on this proposed information collection or to obtain a copy of the proposal and associated collection instruments, please write to the Office of the Product Manager for Force Protection Systems (PdM-FPS), 5900 Putnam Road, Building 365/Suite 1, (SFAE-IEW-TF),
Office of the Under Secretary of Defense for Personnel and Readiness, DoD.
30-day information collection 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 October 22, 2018.
Comments and recommendations on the proposed information collection should be emailed to Ms. Jasmeet Seehra, DoD Desk Officer, at
Fred Licari, 571-372-0493, or
You may also submit comments and recommendations, identified by Docket ID number and title, by the following method:
•
Requests for copies of the information collection proposal should be sent to Mr. Licari at
Office of the Under Secretary of Defense for Personnel and Readiness, DoD.
30-day information collection 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 October 22, 2018.
Comments and recommendations on the proposed information collection should be emailed to Ms. Jasmeet Seehra, DoD Desk Officer, at
Fred Licari, 571-372-0493, or
You may also submit comments and recommendations, identified by Docket ID number and title, by the following method:
•
Requests for copies of the information collection proposal should be sent to Mr. Licari at
Defense Security Cooperation Agency, Department of Defense.
Arms sales notice.
The Department of Defense is publishing the unclassified text of an arms sales notification.
DSCA at
This 36(b)(1) arms sales notification is published to fulfill the requirements of section 155 of Public Law 104-164 dated July 21, 1996. The following is a copy of a letter to the Speaker of the House of Representatives, Transmittal 18-27 with attached Policy Justification and Sensitivity of Technology.
(i)
(ii)
(iii)
Also included are torpedo containers, Recoverable Exercise Torpedoes (REXTORP) with containers; Fleet Exercise Section (FES) and fuel tanks; air launch accessories for rotary wing aircraft; torpedo launcher interface cabinets; ground handling equipment; torpedo spare parts; training; publications; support and test equipment; U.S. Government and contractor engineering, technical, and logistics support services; and other related elements of logistics and program support.
(iv)
(v)
(vi)
(vii)
(viii)
* As defined in Section 47(6) of the Arms Export Control Act.
The Netherlands requests to buy one hundred six (106) MK 54 conversion kits. Also included are torpedo containers, Recoverable Exercise Torpedoes (REXTORP) with containers; Fleet Exercise Section (FES) and fuel tanks; air launch accessories for rotary wing aircraft; torpedo launcher interface cabinets; ground handling equipment; torpedo spare parts; training; publications; support and test equipment; U.S. Government and contractor engineering, technical, and logistics support services; and other related elements of logistics and program support. The estimated program value is $169 million.
This proposed sale will support the foreign policy and national security objectives of the United States by improving the security of a NATO Ally, which is an important force for political stability and economic progress in Europe.
The Royal Netherlands Navy intends to upgrade its current MK 46 torpedoes to the MK 54 with the purchase of these kits. The Netherlands will have no difficulty absorbing the MK 54 torpedoes.
The proposed sale of this equipment and support will not alter the basic military balance in the region.
The principal contractor will be Raytheon Integrated Defense System, Portsmouth, Rhode Island. There are no known offset agreements proposed in connection with this potential sale.
Implementation of this proposed sale will not require the assignment of any additional U.S. Government or contractor representatives to Netherlands; however, U.S. Government Engineering and Technical Services may be required on an interim basis for installations and integration.
There will be no adverse impact on U.S. defense readiness as a result of this proposed sale.
(vii)
1. The MK 54 Torpedo is a conventional torpedo that can be launched from surface ships, helicopters, and fixed wing aircraft. The MK 54 is an upgrade to the MK 46 Torpedo, which is currently in-service in Netherlands. The upgrade to the MK 54 entails replacement of the torpedo's sonar and guidance and control systems with modem technology. The new guidance and control system uses a mixture of commercial-off-the-shelf and custom-built electronics. The warhead, fuel tank and propulsion system from the MK 46 torpedo are re-used in the MK 54 configuration with minor modifications. There is no sensitive technology in the MK 54 or its support and test equipment. The assembled MK 54 torpedo and several of its individual components are classified CONFIDENTIAL. The MK 54 operational software is classified as SECRET. Netherlands will not be provided with the source code for the MK 54 operational software.
2. If a technologically advanced adversary were to obtain knowledge of the hardware and software elements, the information could be used to develop countermeasures or equivalent systems which might reduce system effectiveness or be used in the development of a system with similar or advanced capabilities.
3. A determination has been made that the Government of the Netherlands can provide substantially the same degree of protection for the sensitive technology being released as the U.S. Government. This sale is necessary in furtherance of the U.S. foreign policy and national security objectives outlined in the Policy Justification.
4. All defense articles and services listed in this transmittal have been authorized for release and export to the Netherlands.
Office of the Assistant Secretary of the Navy, DoD.
Information collection notice.
In compliance with the
Consideration will be given to all comments received by November 19, 2018.
You may submit comments, identified by docket number and title, by any of the following methods:
To request more information on this proposed information collection or to obtain a copy of the proposal and associated collection instruments, please write to Office of the Assistant Secretary of the Navy, Office of Civilian Human Resources (ASN/OCHR), 614 Sicard Street, Building 201, Washington, DC 20374 or call OCHR at [202-685-6466].
The Department of the Navy Reasonable Accommodation Tracker will maintain employment information, contact information, and information related to the disabilities and reasonable accommodations/potential reasonable accommodations for employees, contractors, and applicants for employment who request reasonable accommodations. Reasonable accommodations applicants complete SECNAV 12306/1T Form-Confirmation of Reasonable Accommodation Request, information from the form will be input into the Reasonable Accommodation Tracker. Contact information of deciding officials and health care providers will also be maintained in the system. Data collected is required for DON EEO officials and employees to track, monitor, review, and process requests for reasonable accommodations. Individuals involved in the reasonable accommodation process would not be able to perform their official duties of processing or deciding on cases if the subject information is not collected and maintained by DON EEO personnel. Official Reasonable Accommodation case files are secured with access granted on a strictly limited basis. Case files will be retained for the duration of that individual's employment with the Department of the Navy. Case files maintained will be retained and disposed of in accordance with the provisions of the OPM Government wide Systems of Records, 65 CFR 27432.
Department of the Navy, DoD.
Notice of a modified system of records; correction.
On September 5, 2018, the Department of Defense published a system of records notice that proposed to modify Family and Unaccompanied Housing Program, NM11101-1. Subsequent to the publication of the notice, DoD discovered that the system number had published incorrectly. This notice corrects that error.
This correction is applicable on September 20, 2018.
Patricia Toppings, 571-372-0485.
On September 5, 2018 (83 FR 45112-45115), the Department of Defense published a system of records notice, FR Doc. 2018-19204, that proposed to modify Family and Unaccompanied Housing Program, NM11101-1. Subsequent to the publication of the notice, DoD discovered that the system name had published incorrectly. The system name incorrectly published as “NM1110-01” in the two places it appeared in the notice. The system name is corrected as follows:
1. On page 45112, in the first column, in the SUMMARY paragraph, “NM1110-01” is corrected to read “NM11101-1.”
2. On page 45112, in the third column, in the SYSTEM NAME AND NUMBER paragraph, “NM1110-01” is corrected to read “NM11101-1.”
Federal Student Aid (FSA), Department of Education (ED).
Notice.
In accordance with the Paperwork Reduction Act of 1995, ED is proposing an extension of an existing information collection.
Interested persons are invited to submit comments on or before November 19, 2018.
To access and review all the documents related to the information collection listed in this notice, please use
For specific questions related to collection activities, please contact Beth Grebeldinger, 202-377-4018.
The Department of Education (ED), in accordance with the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3506(c)(2)(A)), provides the general public and Federal agencies with an opportunity to comment on proposed, revised, and continuing collections of information. This helps the Department assess the impact of its information collection requirements and minimize the public's reporting burden. It also helps the public understand the Department's information collection requirements and provide the requested data in the desired format. ED is soliciting comments on the proposed information collection request (ICR) that is described below. The Department of Education is especially interested in public comment addressing the following issues: (1) Is this collection
The following notice of meeting is published pursuant to section 3(a) of the government in the Sunshine Act (Pub. L. 94-409), 5 U.S.C. 552b:
Federal Energy Regulatory Commission.
September 20, 2018 10:00 a.m.
Room 2C, 888 First Street NE, Washington, DC 20426.
Open.
Agenda
Items listed on the agenda may be deleted without further notice.
Kimberly D. Bose, Secretary, Telephone (202) 502-8400.
For a recorded message listing items struck from or added to the meeting, call (202) 502-8627.
This is a list of matters to be considered by the Commission. It does not include a listing of all documents relevant to the items on the agenda. All public documents, however, may be viewed on line at the Commission's website at
A free webcast of this event is available through
Immediately following the conclusion of the Commission Meeting, a press briefing will be held in the Commission Meeting Room. Members of the public may view this briefing in the designated overflow room. This statement is intended to notify the public that the press briefings that follow Commission meetings may now be viewed remotely at Commission headquarters, but will not be telecast through the Capitol Connection service.
Tuesday, September 25, 2018 at 10:00 a.m.
1050 First Street NE, Washington, DC.
This Meeting will be Closed to the Public.
Compliance matters pursuant to 52 U.S.C. 30109. Matters concerning participation in civil actions or proceedings or arbitration.
Judith Ingram, Press Officer, Telephone: (202) 694-1220.
Agency for Healthcare Research and Quality (AHRQ), HHS.
Request for Supplemental Evidence and Data Submissions.
The Agency for Healthcare Research and Quality (AHRQ) is seeking scientific information submissions from the public. Scientific information is being solicited to inform our review of
Jenae Benns, Telephone: 301-427-1496 or Email:
The Agency for Healthcare Research and Quality has commissioned the Evidence-based Practice Centers (EPC) Program to complete a review of the evidence for
This is to notify the public that the EPC Program would find the following
• A list of completed studies that your organization has sponsored for this indication. In the list, please
•
•
• Description of whether the above studies constitute ALL Phase II and above clinical trials sponsored by your organization for this indication and an index outlining the relevant information in each submitted file.
Your contribution will be very beneficial to the EPC Program. Materials submitted must be publicly available or able to be made public. Materials that are considered confidential; marketing materials; study types not included in the review; or information on indications not included in the review cannot be used by the EPC Program. This is a voluntary request for information, and all costs for complying with this request must be borne by the submitter.
The draft of this review will be posted on AHRQ's EPC Program website and available for public comment for a period of 4 weeks. If you would like to be notified when the draft is posted, please sign up for the email list at:
The systematic review will answer the following questions. This information is provided as background. AHRQ is not requesting that the public provide answers to these questions.
The Key Questions (KQs)
1a. In adolescents and children, what are the benefits and harms of nonpharmacological interventions for depressive disorders (defined as MDD or PDD/DD)?
1b. How do these benefits and harms vary by subpopulation (
2a. In adolescents and children, what are the benefits and harms of pharmacological interventions for depressive disorders (defined as MDD or PDD/DD)?
2b. How do the benefits and harms vary by subpopulation (
3a. In adolescents and children, what are the benefits and harms of combination interventions for depressive disorders (defined as MDD or PDD/DD)?
3b. How do the benefits and harms vary by subpopulation (
4a: In adolescents and children, what are the benefits and harms of collaborative care interventions for depressive disorders (defined as MDD or PDD/DD)?
4b: How do the benefits and harms vary by subpopulation (
5a: In adolescents and children, what are the comparative benefits and harms of treatments (pharmacological, nonpharmacological, combined, collaborative care interventions) for depressive disorders (defined as MDD or PDD/DD)?
5b. How do these benefits and harms vary by subpopulation (
Centers for Disease Control and Prevention (CDC), Department of Health and Human Services (HHS).
Notice.
The Centers for Disease Control and Prevention (CDC) located within the Department of Health and Human Services (HHS) is publishing the names of the Performance Review Board Members who are reviewing performance for Fiscal Year 2018.
Sandra DeShields, Chief, Compensation and Performance Management Team, Executive and Scientific Resources Office, Human Resources Office, Centers for Disease Control and Prevention, 11 Corporate Square Blvd., Mailstop US11-2, Atlanta, Georgia 30341, Telephone (770) 488-0252.
Title 5, U.S.C. Section 4314(c)(4) of the Civil Service Reform Act of 1978, Public Law 95-454, requires that the appointment of Performance Review Board Members be published in the
Centers for Medicare & Medicaid Services (CMS), HHS.
Notice.
This notice announces the annual adjustment in the amount in controversy (AIC) threshold amounts for Administrative Law Judge (ALJ) hearings and judicial review under the Medicare appeals process. The adjustment to the AIC threshold amounts will be effective for requests for ALJ hearings and judicial review filed on or after January 1, 2019. The calendar year 2019 AIC threshold amounts are $160 for ALJ hearings and $1,630 for judicial review.
This annual adjustment is effective for requests for ALJ hearings and judicial review filed on or after January 1, 2019.
Liz Hosna (
Section 1869(b)(1)(E) of the Social Security Act (the Act), as amended by section 521 of the Medicare, Medicaid, and SCHIP Benefits Improvement and Protection Act of 2000 (BIPA), established the amount in controversy (AIC) threshold amounts for Administrative Law Judge (ALJ) hearings and judicial review at $100 and $1,000, respectively, for Medicare Part A and Part B appeals. Section 940 of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA), amended section 1869(b)(1)(E) of the Act to require the AIC threshold amounts for ALJ hearings and judicial review to be adjusted annually. Beginning in January 2005, the AIC threshold amounts are to be adjusted by the percentage increase in the medical care component of the consumer price index (CPI) for all urban consumers (U.S. city average) for July 2003 to July of the year preceding the year involved and rounded to the nearest multiple of $10. Section 940(b)(2) of the MMA provided conforming amendments to apply the AIC adjustment requirement to Medicare Part C/Medicare Advantage (MA) appeals and certain health maintenance organization and competitive health plan appeals. Health care prepayment plans are also subject to MA appeals rules, including the AIC adjustment requirement. Section 101 of the MMA provides for the application of the AIC adjustment requirement to Medicare Part D appeals.
The statutory formula for the annual adjustment to the AIC threshold amounts for ALJ hearings and judicial review of Medicare Part A and Part B appeals, set forth at section 1869(b)(1)(E) of the Act, is included in the applicable implementing regulations, 42 CFR 405.1006(b) and (c). The regulations require the Secretary of Health and Human Services (the
Section 940(b)(2) of the MMA applies the AIC adjustment requirement to Medicare Part C appeals by amending section 1852(g)(5) of the Act. The implementing regulations for Medicare Part C appeals are found at 42 CFR 422, subpart M. Specifically, §§ 422.600 and 422.612 discuss the AIC threshold amounts for ALJ hearings and judicial review. Section 422.600 grants any party to the reconsideration (except the MA organization) who is dissatisfied with the reconsideration determination a right to an ALJ hearing as long as the amount remaining in controversy after reconsideration meets the threshold requirement established annually by the Secretary. Section 422.612 states, in part, that any party, including the MA organization, may request judicial review if the AIC meets the threshold requirement established annually by the Secretary.
Section 1876(c)(5)(B) of the Act states that the annual adjustment to the AIC dollar amounts set forth in section 1869(b)(1)(E)(iii) of the Act applies to certain beneficiary appeals within the context of health maintenance organizations and competitive medical plans. The applicable implementing regulations for Medicare Part C appeals are set forth in 42 CFR 422, subpart M and apply to these appeals in accordance with 42 CFR 417.600(b). The Medicare Part C appeals rules also apply to health care prepayment plan appeals in accordance with 42 CFR 417.840.
The annually adjusted AIC threshold amounts for ALJ hearings and judicial review that apply to Medicare Parts A, B, and C appeals also apply to Medicare Part D appeals. Section 101 of the MMA added section 1860D-4(h)(1) of the Act regarding Part D appeals. This statutory provision requires a prescription drug plan sponsor to meet the requirements set forth in sections 1852(g)(4) and (g)(5) of the Act, in a similar manner as MA organizations. As noted previously, the annually adjusted AIC threshold requirement was added to section 1852(g)(5) of the Act by section 940(b)(2)(A) of the MMA. The implementing regulations for Medicare Part D appeals can be found at 42 CFR 423, subparts M and U. The regulations at § 423.562(c) prescribe that, unless the Part D appeals rules provide otherwise, the Part C appeals rules (including the annually adjusted AIC threshold amount) apply to Part D appeals to the extent they are appropriate. More specifically, §§ 423.1970 and 423.1976 of the Part D appeals rules discuss the AIC threshold amounts for ALJ hearings and judicial review. Section 423.1970(a) grants a Part D enrollee, who is dissatisfied with the independent review entity (IRE) reconsideration determination, a right to an ALJ hearing if the amount remaining in controversy after the IRE reconsideration meets the threshold amount established annually by the Secretary. Sections 423.1976(a) and (b) allow a Part D enrollee to request judicial review of an ALJ or Medicare Appeals Council decision if, in part, the AIC meets the threshold amount established annually by the Secretary.
As previously noted, section 940 of the MMA requires that the AIC threshold amounts be adjusted annually, beginning in January 2005, by the percentage increase in the medical care component of the CPI for all urban consumers (U.S. city average) from July 2003 to July of the year preceding the year involved and rounded to the nearest multiple of $10.
The AIC threshold amount for ALJ hearings will remain at $160 and the AIC threshold amount for judicial review will rise to $1,630 for CY 2019. These amounts are based on the 63.035 percent increase in the medical care component of the CPI, which was at 297.600 in July 2003 and rose to 485.193 in July 2018. The AIC threshold amount for ALJ hearings changes to $163.04 based on the 63.035 percent increase over the initial threshold amount of $100 established in 2003. In accordance with section 1869(b)(1)(E)(iii) of the Act, the adjusted threshold amounts are rounded to the nearest multiple of $10. Therefore, the CY 2019 AIC threshold amount for ALJ hearings is $160.00. The AIC threshold amount for judicial review changes to $1,630.35 based on the 63.035 percent increase over the initial threshold amount of $1,000. This amount was rounded to the nearest multiple of $10, resulting in the CY 2019 AIC threshold amount of $1,630.00 for judicial review.
In the following table we list the CYs 2015 through 2019 threshold amounts.
This document does not impose information collection requirements, that is, reporting, recordkeeping or third-party disclosure requirements. Consequently, there is no need for review by the Office of Management and Budget under the authority of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501
Centers for Medicare & Medicaid Services (CMS), Department of Health and Human Services (HHS).
Notice of New Matching Program.
In accordance with subsection (e)(12) of the Privacy Act of 1974, as amended, the Department of Health and Human Services (HHS), Centers for Medicare & Medicaid Services (CMS) is providing notice of a new computer matching program between CMS and the Department of Homeland Security (DHS)/United States Citizenship and Immigration Services (USCIS), “Verification of United States Citizenship and Immigration Status Data for Eligibility Determinations.” In this matching program, DHS/USCIS provides CMS with immigrant, nonimmigrant, and naturalized or derived citizenship status information needed to make enrollment and exemption eligibility determinations as required by the Patient Protection and Affordable Care Act (ACA).
The deadline for comments on this notice is October 22, 2018. The re-established matching program will commence not sooner than 30 days after publication of this notice, provided no comments are received that warrant a change to this notice. The matching program will be conducted for an initial term of 18 months (from approximately October 2018 to April 2020) and within 3 months of expiration may be renewed for one additional year if the parties make no change to the matching program and certify that the program has been conducted in compliance with the matching agreement.
Interested parties may submit comments on the new matching program to the CMS Privacy Officer by mail at: Division of Security, Privacy Policy & Governance, Information Security & Privacy Group, Office of Information Technology, Centers for Medicare & Medicaid Services, Location: N1-14-56, 7500 Security Blvd., Baltimore, MD 21244-1850, or
If you have questions about the matching program, you may contact Jack Lavelle, Senior Advisor, Marketplace Eligibility and Enrollment Group, Centers for Consumer Information and Insurance Oversight, CMS, at (410) 786-0639, by email at
The Privacy Act of 1974, as amended (5 U.S.C. 552a) provides certain protections for individuals applying for and receiving federal benefits. The law governs the use of computer matching by federal agencies when records in a system of records (meaning, federal agency records about individuals retrieved by name or other personal identifier) are matched with records of other federal or non-federal agencies. The Privacy Act requires agencies involved in a matching program to:
1. Enter into a written agreement, which must be prepared in accordance with the Privacy Act, approved by the Data Integrity Board of each source and recipient federal agency, provided to Congress and the Office of Management and Budget (OMB), and made available to the public, as required by 5 U.S.C. 552a(o), (u)(3)(A), and (u)(4).
2. Notify the individuals whose information will be used in the matching program that the information they provide is subject to verification through matching, as required by 5 U.S.C. 552a(o)(1)(D).
3. Verify match findings before suspending, terminating, reducing, or making a final denial of an individual's benefits or payments or taking other adverse action against the individual, as required by 5 U.S.C. 552a(p).
4. Report the matching program to Congress and the OMB, in advance and annually, as required by 5 U.S.C. 552a(o) (2)(A)(i), (r), and (u)(3)(D).
5. Publish advance notice of the matching program in the
This matching program meets these requirements.
The Department of Health and Human Services (HHS), Centers for Medicare & Medicaid Services (CMS) is the recipient agency, and the Department of Homeland Security (DHS), United States Citizenship and Immigration Services (USCIS) is the source agency.
The statutory authority for the matching program is 42 U.S.C. 18001.
The matching program will provide CMS with USCIS data, including immigrant, nonimmigrant, and naturalized or derived citizenship status information from USCIS's SAVE program and VIS system. This data will indicate whether an applicant or enrollee is lawfully present, a qualified non-citizen, a naturalized or derived citizen, and whether the five-year waiting period for many non-citizens applies and has been met. CMS and state administering entities will use the data to determine the individual's eligibility for enrollment in a qualified health plan through a federally-facilitated exchange (FFE) and for insurance affordability programs and certificates of exemption, and to make eligibility redetermination and renewal decisions, including appeal determinations. USCIS will provide the data from USCIS's SAVE program and VIS system about individuals whose identifying information matches identifying information that CMS submits to USCIS. CMS will make the USCIS data available to requesting state administering entities through a data services hub (Hub).
The individuals whose information will be used in the matching program are consumers who apply for any of the following eligibility determinations: eligibility to enroll in a qualified health plan through an exchange established under the ACA, eligibility for insurance affordability programs and certificates of exemption, and subsequent eligibility redeterminations and renewals, including appeal determinations
The categories of records used in the matching program are identity and citizenship status records. The data elements are described below.
•
•
The records used in this matching program are disclosed from the following systems of records, as authorized by routine uses published in the System of Records Notices (SORNs) cited below:
• CMS Health Insurance Exchanges System (HIX), CMS System No. 09-70-0560, last published in full at 78 FR 63211 (Oct. 23, 2013), as amended at 83 FR 6591 (Feb. 14, 2018). Routine use 3 supports CMS's disclosures to USCIS.
• DHS/USCIS-004 Systematic Alien Verification for Entitlements Program, 81 FR 78619 (Nov. 8, 2016). Routine use H permits USCIS' disclosures to CMS.
Food and Drug Administration, HHS.
Notice of availability.
The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled “Grandfathering Policy for Packages and Homogenous Cases of Product Without a Product Identifier.” This guidance specifies whether and under what circumstances packages and homogenous cases of product not labeled with a product identifier shall be grandfathered from certain requirements of the Federal Food, Drug, and Cosmetic Act (FD&C Act). This guidance finalizes the draft guidance issued on November 27, 2017.
The announcement of the guidance is published in the
You may submit either electronic or written comments on Agency guidances at any time 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 Dockets Management Staff, 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
You may submit comments on any guidance at any time (see 21 CFR 10.115(g)(5)).
Submit written requests for single copies of this 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, or the Office of Communication, Outreach, and Development, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993-0002. Send one self-addressed adhesive label to assist that office in processing your requests. See the
Abha Kundi, Office of Compliance, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993-0002, 301-796-3130,
FDA is announcing the availability of a guidance for industry entitled “Grandfathering Policy for Packages and Homogenous Cases of Product Without a Product Identifier.” On November 27, 2013, the Drug Supply Chain Security Act (DSCSA) (Title II of Pub. L. 113-54) was signed into law. Section 202 of the DSCSA added section 582 to the FD&C Act (21 U.S.C. 360eee-1), which established product tracing requirements for manufacturers, repackagers, wholesale distributors, and dispensers. The DSCSA phases in its requirements over a 10-year period.
A critical set of phased product tracing requirements outlined in section 582 of the FD&C Act relates to the product identifier. Among its provisions, section 582 of the FD&C Act requires that each package and homogenous case of product in the pharmaceutical distribution supply chain bear a product identifier that is encoded with the product's standardized numerical identifier, lot number, and expiration date by specific dates. Under the statute, manufacturers were required to begin affixing or imprinting a product identifier to each package and homogenous case of a product intended to be introduced into commerce no later than November 27, 2017. Repackagers are required to do the same no later than November 27, 2018.
Sections 582(c)(2), (d)(2), and (e)(2)(A)(iii) of the FD&C Act restrict trading partners' ability to engage in transactions involving packages and homogenous cases of product that are not labeled with a product identifier after specific dates. Beginning November 27, 2018, repackagers may not engage in a transaction involving a package or homogenous case of a product that is not encoded with a product identifier. Similar restrictions go into effect for wholesale distributors and dispensers on November 27, 2019, and November 27, 2020, respectively.
In addition, section 582 of the FD&C Act requires trading partners to verify product identifiers on packages and homogenous cases starting on November 27, 2017, for manufacturers (section 582(b)(4)); on November 27, 2019, for wholesale distributors (section 582(c)(4)); on November 27, 2020, for dispensers (section 582(d)(4)); and on November 27, 2018, for repackagers (section 582(e)(4)). Manufacturers, repackagers, wholesale distributors, and dispensers are also required to verify the product identifier of a saleable returned package or sealed homogenous case on November 27, 2017, November 27, 2018, November 27, 2019, and November 27, 2020, respectively.
In section 582(a)(5)(A) of the FD&C Act, Congress directed FDA to issue guidance specifying “whether and under what circumstances product that is not labeled with a product identifier and that is in the pharmaceutical supply chain at the time at the time of the effective date of the requirements of [section 582] shall be exempted” from the product tracing requirements discussed previously. The guidance addresses this requirement. As explained in the guidance, only packages and homogenous cases of product that are in the pharmaceutical distribution supply chain at the time of the effective date of the requirements of section 582 are eligible for grandfathering under section 582(a)(5)(A) of the FD&C Act.
In the
This guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The guidance represents the current thinking of FDA on “Grandfathering Policy for Packages and Homogenous Cases of Product Without a Product Identifier.” It does not establish any rights for any person and, with the exception of specified material in section IV, 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 guidance is not subject to Executive Order 12866.
Persons with access to the internet may obtain the guidance at
Food and Drug Administration, HHS.
Notice of availability.
The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance entitled “Heparin-Containing Medical Devices and Combination Products: Recommendations for Labeling and Safety Testing.” The United States Pharmacopeia (USP) drug substance monograph for Heparin Sodium, and drug product monographs for Heparin Lock Flush Solution and Heparin Sodium Injection, recently have undergone several revisions following serious and fatal events related to the use of heparin sodium products. Investigation of heparin product overdose errors identified the expression of drug strength in the labels as a major contributing factor in these errors. This guidance document addresses these safety concerns by clarifying new expectations for labeling with regard to the revised heparin USP monographs, as well as outlining safety testing recommendations.
The announcement of the guidance is published in the
You may submit either electronic or written comments on Agency guidances at any time 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 Dockets Management Staff, 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
You may submit comments on any guidance at any time (see 21 CFR 10.115(g)(5)).
An electronic copy of the guidance document is available for download from the internet. See the
Andrew Yeatts, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 1643, Silver Spring, MD 20993-0002, 301-796-4539.
The USP
In addition, the outbreak of serious and often fatal events due to heparin contamination with over-sulfated chondroitin sulfate in 2008 led the USP to include in its monograph additional testing of heparin source material to ensure its quality and purity. This guidance also outlines use of conformance to the monograph in premarket submissions, specifically testing and documentation requirements and/or recommendations contained in the current USP monographs and the guidance document “Heparin for Drug and Medical Device Use: Monitoring Crude Heparin for Quality” (
FDA considered comments received on the draft guidance that appeared in the
This guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The guidance represents the current thinking of FDA on “Heparin-Containing Medical Devices and Combination Products: Recommendations for Labeling and Safety Testing.” 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 guidance is not subject to Executive Order 12866.
Persons interested in obtaining a copy of the guidance may do so by downloading an electronic copy from the internet. A search capability for all Center for Devices and Radiological Health guidance documents is available at
This guidance refers to previously approved collections of information. These collections of information are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The collections of information in the following FDA regulations and guidance have been approved by OMB as listed in the following table:
Food and Drug Administration, HHS.
Notice of availability.
The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled “Product Identifier Requirements Under the Drug Supply Chain Security Act—Compliance Policy.” This guidance describes FDA's intention with regard to enforcement of the Drug Supply Chain Security Act (DSCSA) provision requiring manufacturers to begin affixing or imprinting product identifiers on their products beginning November 27, 2017. This guidance finalizes the draft guidance issued on July 3, 2017.
The announcement of the guidance is published in the
You may submit either electronic or written comments on Agency Guidance at any time 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 Dockets Management Staff, 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, or the Office of Communication, Outreach and Development, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Building 71, Rm. 3128, Silver Spring, MD 20993-0002. Send one self-addressed adhesive label to assist that office in processing your requests. See the
Connie Jung, Office of Compliance, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993-0002, 301-796-3130,
FDA is announcing the availability of a guidance for industry entitled “Product Identifier Requirements Under the Drug Supply Chain Security Act—Compliance Policy.” On November 27, 2013, the DSCSA (Title II of Pub. L. 113-54) was signed into law. Section 202 of the DSCSA added section 582 to the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 360eee-1) which established product tracing, product identifier, authorized trading partner and verification requirements for manufacturers, repackagers, wholesale distributors, and dispensers to facilitate the tracing of products through the pharmaceutical distribution supply chain. Among its provisions, section 582 of the FD&C Act requires that each package and homogenous case of product in the pharmaceutical distribution supply chain bear a product identifier that is encoded with the product's standardized numerical identifier, lot number, and expiration date by specific dates. Under the statute, manufacturers were required to begin affixing or imprinting a product identifier to each package and homogenous case of a product intended to be introduced into commerce no later than November 27, 2017. Failure to comply with this and other requirements of section 582 is prohibited under section 301(t) of the FD&C Act (21 U.S.C. 331(t)) and subject to enforcement action under the FD&C Act.
In the
FDA made several changes to the guidance. We streamlined the guidance to remove information that is portions of the draft version of this guidance because they were repetitive of the information in the final guidance for industry entitled, “Grandfathering Policy for Packages and Homogenous Cases of Product Without a Product Identifier.” In addition, FDA removed the language in the draft version of this guidance on wholesale distributor and dispenser responsibilities to ensure product purchased from repackagers after November 27, 2018, is affixed or imprinted with a product identifier. Finally, FDA removed the recommendations in the draft version of this guidance related to the documentation for determining when a product without a product identifier was introduced in a transaction into commerce by a manufacturer. The topic of documentation is addressed in the final grandfathering policy guidance.
This guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The guidance represents the current thinking of FDA on “Product Identifier Requirements Under the Drug Supply Chain Security Act—Compliance Policy.” 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 guidance is not subject to Executive Order 12866.
Persons with access to the internet may obtain the guidance at
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 “Product Identifiers Under the Drug Supply Chain Security Act Questions and Answers.” This draft guidance intends to clarify questions relating to product identifiers that are required by the Federal Food, Drug, and Cosmetic Act
Submit either electronic or written comments on the draft guidance by November 19, 2018 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 concerning the collection of information proposed in the draft guidance by November 19, 2018.
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 Dockets Management Staff, 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
You may submit comments on any guidance at any time (see 21 CFR 10.115(g)(5)).
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; or to the Office of Communication, Outreach and Development, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993-0002. Send one self-addressed adhesive label to assist that office in processing your requests. See the
Tia Harper-Velazquez, Office of Compliance, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993-0002, 301-796-3130,
The DSCSA (Title II of Pub. L. 113-54) was signed into law on November 27, 2013. Section 202 of the DSCSA added section 582 to the FD&C Act (21 U.S.C. 360eee-1). This section establishes product tracing, product identifier, and verification requirements for manufacturers, repackagers, wholesale distributors, and dispensers to facilitate the tracing of products through the pharmaceutical distribution supply chain. Failure to comply with the requirements of section 582 is a prohibited act under section 301(t) of the FD&C Act (21 U.S.C. 331(t)).
The effective date for manufacturers to “affix or imprint a product identifier to each package and homogenous case of a product intended to be introduced in a transaction into commerce” under section 582(b)(2)(A) of the FD&C Act, is not later than November 27, 2017. In June 2017, FDA published a draft guidance entitled “Product Identifier Requirements Under the Drug Supply Chain Security Act—Compliance Policy,” in which FDA describes its intention regarding the enforcement of certain product identifiers under the DSCSA. As described in the draft guidance, FDA does not intend to take action against manufacturers who do not affix or imprint a product identifier to each package and homogenous case of products intended to be introduced in a transaction into commerce before November 26, 2018. This represents a 1-year delay in enforcement of the requirement for manufacturers to affix or imprint product identifiers. The
This guidance is intended to assist manufacturers and repackagers in understanding the requirements to affix or imprint a product identifier on each package and homogenous case of product that they introduce in a transaction into commerce to satisfy the product identifier requirement of section 582 of the FD&C Act. The recommendations in this guidance are intended to assist manufacturers and repackagers in standardizing both the human-readable and machine-readable format of the information that is contained in the product identifier. This guidance also intends to clarify that these requirements do not change the linear barcode requirements.
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 “Product Identifiers Under the Supply Chain Security Act Questions and Answers.” 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 guidance is not subject to Executive Order 12866.
This draft guidance includes information collection provisions that are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act (PRA) of 1995 (44 U.S.C. 3501-3520) (PRA). In accordance with the PRA, prior to publication of any final guidance document, FDA intends to solicit public comment and obtain OMB approval for any information collections recommended in this guidance that are new or that would represent material modifications to those previously approved collections of information found in FDA regulations or guidances.
Persons with access to the internet may obtain the draft guidance at either
Health Resources and Services Administration (HRSA), Department of Health and Human Services (HHS).
Notice.
The Advisory Committee on Heritable Disorders in Newborns and Children (ACHDNC) has scheduled a public meeting. Information about the ACHDNC, a roster of members, the meeting agenda, as well as past meeting summaries is located on the ACHDNC website at
November 1, 2018, 10:30 a.m.-5:30 p.m. ET and November 2, 2018, 9:00 a.m.-3:00 p.m. ET.
This meeting will be held in person and by webinar. Advanced registration is required. Please register online at
Ann Ferrero, Maternal and Child Health Bureau (MCHB), HRSA, 5600 Fishers Lane, Room 18N100C, Rockville, Maryland 20857; 301-443-3999; or
The ACHDNC provides advice and recommendations to the Secretary of HHS (Secretary) on the development of newborn screening activities, technologies, policies, guidelines, and programs for effectively reducing morbidity and mortality in newborns and children having, or at risk for, heritable disorders. In addition, ACHDNC's recommendations regarding inclusion of additional conditions for screening, following adoption by the Secretary, are evidence-informed preventive health services provided for in the comprehensive guidelines supported by HRSA through the Recommended Uniform Screening Panel (RUSP) pursuant to section 2713 of the Public Health Service Act (42 U.S.C. 300gg-13). Under this provision, non-grandfathered group health plans and health insurance issuers offering group or individual health insurance are required to provide insurance coverage without cost-sharing (a co-payment, co-insurance, or deductible) for preventive services for plan years (
During the November meeting, the ACHDNC will hear from experts in the field and discuss issues related to newborn screening information, education, training activities, and training resources. The ACHDNC will hear presentations on the use of genomic sequencing in newborn screening as well as the clinical setting for both well and sick infants. The ACHDNC will also discuss the nomination of cerebrotendinous xanthomatosis (CTX) to the RUSP and vote on whether to move the nomination forward to evidence review. Note that this vote is not on a proposed addition of a condition to the RUSP. Agenda items are subject to change as priorities dictate. Refer to the ACHDNC website for any updated information concerning the meeting. Members of the public will have the opportunity to provide comments, which are part of the official Committee record. To submit written comments or request time for an oral comment at the meeting, please register online by 12:00 p.m. ET on October 26, 2018, at
Individuals who plan to attend and need special assistance or another reasonable accommodation should notify Ann Ferrero at the address and phone number listed above at least 10 business days prior to the meeting. Since this meeting occurs in a federal government building, attendees must go through a security check to enter the building. Non-U.S. Citizens attendees planning to attend must notify HRSA of their planned attendance at least 10 business days prior to the meeting in
Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended, notice is hereby given of a meeting of the National Cancer Institute Council of Research Advocates.
The meeting will be open to the public, with attendance limited to space available. Individuals who plan to attend and need special assistance, such as sign language interpretation or other reasonable accommodations, should notify the Contact Person listed below in advance of the meeting. The open session will be videocast and can be accessed from the NIH Videocasting and Podcasting website (
Any interested person may file written comments with the committee by forwarding the statement to the Contact Person listed on this notice. The statement should include the name, address, telephone number and when applicable, the business or professional affiliation of the interested person.
In the interest of security, NIH has instituted stringent procedures for entrance onto the NIH campus. All visitor vehicles, including taxicabs, hotel, and airport shuttles will be inspected before being allowed on campus. Visitors will be asked to show one form of identification (for example, a government-issued photo ID, driver's license, or passport) and to state the purpose of their visit.
Information is also available on the Institute's/Center's home page: NCRA:
National Institutes of Health, HHS.
Notice.
The invention listed below is owned by an agency of the U.S. Government and is available for licensing to achieve expeditious commercialization of results of federally-funded research and development. Foreign patent applications are filed on selected inventions to extend market coverage for companies and may also be available for licensing.
Barry Buchbinder, Ph.D., 240-627-3678;
Technology description follows.
The VRC01-class of potent, broadly neutralizing antibodies (bnAbs) targets the conserved CD4-binding site (CD4bs) of HIV-1 Env which has been a major target of HIV-vaccine design. The current best priming immunogen to engage the VRC01-class germline precursors is the eOD-GT8 60mer, which elicits VRC01-class precursors in multiple transgenic mouse models. However, a large proportion of the antibodies elicited by eOD-GT8 60mer are non-CD4bs or “off-target” antibodies, undermining its effectiveness in eliciting the VRC01-class bnAb precursors.
Researchers at the Vaccine Research Center (VRC) of the National Institute of Allergy and Infectious Diseases introduced multiple N-linked glycosylation sites to mask non-CD4bs regions of eOD-GT8 60mer to focus the antibody immune response to the CD4bs.
Several glycan-masked mutants showed significantly decreased antibody binding to non-CD4bs “off-target” epitopes while maintaining strong binding to CD4bs-specific bnAbs. Furthermore, in vivo studies showed that immunization with the best glycan-masked eOD-GT8 mutants resulted in significant increases in the elicitation of CD4bs-specific serum antibodies, CD4bs-specific B cells in the spleen, and VRC01-class precursors, compared to immunization with the parental eOD-GT8 immunogen. In conclusion, because of their improved antigenic and immunogenic profiles, glycan-masked eOD-GT8 60mer mutants may serve as improved priming immunogens to elicit VRC01-class bnAbs in humans.
• HIV-1 vaccine—the priming component in a prime-boost approach.
• Reduced off-target immunogenicity.
• Improved efficacy in eliciting precursors for broadly neutralizing CD4bs antibodies.
• Facilitates the development of VRC01-class bnAbs in humans.
Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended, notice is hereby given of the following meetings.
The meetings will be closed to the public in accordance with the provisions set forth in section 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.
Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended, notice is hereby given of the following meeting.
The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.
Notice is hereby given of a change in the meeting of the Molecular Genetics B Study Section, September 27, 2018, 10:00 a.m. to September 28, 2018, 06:00 p.m., National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD, 20892 which was published in the
The meeting will be held on September 27, 2018, starting at 8:30 a.m. The meeting location remains the same. The meeting is closed to the public.
Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended, notice is hereby given of the following meetings.
The meetings will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.
Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended, notice is hereby given of the following meeting.
The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.
Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended, notice is hereby given of the following meetings.
The meetings will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.
Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended, notice is hereby given of the following meetings.
The meetings will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The contract proposals and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the contract proposals, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.
Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended, notice is hereby given of a meeting Microbiology, Infectious Diseases and AIDS Initial Review Group Microbiology and Infectious Diseases Research Committee.
The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.
Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended, notice is hereby given of the following meetings.
The meetings will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.
Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended, notice is hereby given of the following meeting.
The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.
National Institutes of Health, HHS.
Notice.
The National Institutes of Health (NIH) announces Policy Manual Chapter: 1311—Preventing and Addressing Harassment and Inappropriate Conduct and a new Policy Statement addressing Personal Relationships in the Workplace. These policies apply to federal employees, contractors, trainees, and fellows who perform work for the NIH. The NIH expects that organizations receiving NIH funds have in place similarly rigorous policies and related procedures for their employees, contractors, trainees, and fellows who engage in agency-funded activities.
For further information about these new policies, contact Jessica Hawkins, Office of Human Resources, National Institutes of Health, Building 31, Room 1/B37, Bethesda, Maryland 20892, telephone 301-402-8006 (not a toll-free number),
Policy Manual 1311—Preventing and Addressing Harassment and Inappropriate Conduct states that the NIH will not tolerate inappropriate conduct or harassment, including sexual harassment. Timely and appropriate action will be taken against any individual found to be in violation of the policy outlined in the Manual Chapter. Through enforcement of this policy, the NIH seeks to prevent, correct, and eliminate unacceptable behavior that is inconsistent with the values and culture of respect and inclusion. Further, the policy is intended to increase the transparency and consistency in how allegations of harassment are reviewed and resolved. NIH leadership has designated the Office of Human Resources' Civil Program as the entity charged with receiving allegations of harassment and overseeing relevant administrative inquiries.
The NIH Policy Statement on Personal Relationships in the Workplace states that personal relationships (including romantic and/or sexual) between individuals in inherently unequal positions, where one party has real or perceived authority over the other in their professional roles, may be inappropriate in the workplace and are strongly discouraged. If such a relationship exists or develops, it must be disclosed. Upon such notification, the responsible agency official must insure that the NIH Institute/Center manages, decreases, or eliminates potential risk as a result of the relationship.
This applies to all individuals in the NIH community, including employees, contractors, students, trainees, and fellows and includes anyone who holds a position of authority or perceived
Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended, notice is hereby given of the following meetings.
The meetings will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.
Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended, notice is hereby given of the following meetings.
The meetings will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.
Notice is hereby given of a change in the meeting of the National Advisory Council for Complementary and Integrative Health, October 5, 2018, 8:30 a.m. to October 5, 2018, 04:00 p.m., National Institutes of Health, Building 31, 31 Center Drive, Conference Room 10, Bethesda, MD 20892 which was published in the
This meeting notice is amended to change the starting time of the OPEN SESSION from 10:00 a.m. to 9:30 a.m. (EDT). The meeting is partially Closed to the public.
Transportation Security Administration, DHS.
30-Day notice.
This notice announces that the Transportation Security Administration (TSA) has forwarded the Information Collection Request (ICR), Office of Management and Budget (OMB) control number 1652-0039, abstracted below to OMB for review and approval of a revision of the currently approved collection under the Paperwork Reduction Act (PRA). The ICR describes the nature of the information collection and its expected burden. The collection involves the submission of information from claimants to examine and resolve tort claims against the agency.
Send your comments by October 22, 2018. A comment to OMB is most effective if OMB receives it within 30 days of publication.
Interested persons are invited to submit written comments on the proposed information collection to the Office of Information and Regulatory Affairs, OMB. Comments should be addressed to Desk Officer, Department of Homeland Security/TSA, and sent via electronic mail to
Christina A. Walsh, TSA PRA Officer, Information Technology (IT), TSA-11, Transportation Security Administration, 601 South 12th Street, Arlington, VA 20598-6011; telephone (571) 227-2062; email
TSA published a
In accordance with the Paperwork Reduction Act of 1995 (44 U.S.C. 3501
(1) Evaluate whether the proposed information requirement is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility;
(2) Evaluate the accuracy of the agency's estimate of the burden;
(3) Enhance the quality, utility, and clarity of the information to be collected; and
(4) Minimize the burden of the collection of information on those who are to respond, including using appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology.
Consistent with the requirements of Executive Order (E.O.) 13771, Reducing Regulation and Controlling Regulatory Costs, and E.O.13777, Enforcing the Regulatory Reform Agenda, TSA is also requesting comments on the extent to which this request for information could be modified to reduce the burden on respondents.
The claims branch has changed its name from Claims Management Branch to Claims, Outreach, and Debt Branch and is revising the information collection form by changing the name from “TSA Claims Management Branch Program” to “TSA Claims Application.” These changes provide the public with a better understanding of the operational functions conducted when a member of the traveling public files an SF-95, claims application.
TSA receives approximately 850 tort claims per month arising from airport screening activities, motor vehicle accidents, and employee loss, among others.
Office of the Assistant Secretary for Community Planning and Development, HUD.
Notice of Intent (NOI) to prepare an Environmental Impact Statement (EIS).
The City of Los Angeles, through the Housing and Community Development Investment Department (HCID), is providing notice of its intent to prepare a combined Environmental Impact Statement (EIS) in accordance with the National Environmental Policy Act (NEPA) and Environmental Impact Report (EIR) in accordance with the California Environmental Quality Act (CEQA) (EIR/EIS) for the Rose Hill Courts Redevelopment Project located in Los Angeles, CA. The proposed action is subject to compliance with NEPA because the Housing Authority of the City of the City of Los Angeles (HACLA) is proposing a HUD Section 18 demolition/disposition and the developer is planning to use Project Based Section 8 vouchers. HACLA will consider a Disposition and Development Agreement. This Notice of Intent to prepare an EIS represents the beginning of the public scoping process. Following the scoping meeting referenced below, a Draft EIS will be prepared and ultimately circulated.
Comments relating to the scope of the EIR/EIS are requested and will be accepted by the contact persons listed below until October 20, 2018. Any person or agency interested in receiving a notice and wishing to comment on the draft EIR/EIS should contact the persons listed below. Documents are available at the following website:
Dr. Robert Manford, Environmental Affairs Officer, Planning and Land Use, Finance & Development Division of the City of Los Angeles Housing, Community Investment Department, 1200 West 7th Street, 8th Floor, Los Angeles, CA 90017. Comments and questions can also be directed to
HCID will consider a proposal to redevelop the project site including new construction of 191 new affordable housing units, developed in two phases. Proposed improvements include 176 parking spaces, a new property management and maintenance office, and new landscaping. The project site is 5.24-acres in size and is located at 4446 Florizel Street in Los Angeles, California. The site slopes in a west to east direction by +/− 65 feet, and it is currently developed with a total of 15 buildings, comprised of 14 residential buildings with 100-multi-family units, and one administration building (
The project site is bounded by Florizel Street to the north; McKenzie Avenue to the east; Mercury Avenue to the south; and Boundary Avenue to the west. An onsite driveway, Victorine Street, runs in an east-west direction across the middle of the project bisecting the site into two parts: The northern part and the southern part.
Land uses surrounding the project site include the Ernest E. Debs Regional Park to the west, along Mercury Avenue and Boundary Avenue; Rose Hill Park to the north; the Rose Hill Recreation Center to the southeast. Our Lady of Guadalupe Catholic Church and Elementary School is located east of the project site, along Browne Avenue. Single-family and multi-family residential developments are located to the south and east.
The project would require the following discretionary approvals: (1) Disposition and Development Agreement approval from HACLA; (2) Grading and Building Permits from the City of Los Angeles Department of Building and Safety; (3) Public Benefits Project and Alternative Compliance approval from the Los Angeles Department of City Planning; (4) National Environmental Policy Act (NEPA) Part 58 Compliance necessary for Demolition/Disposition and Rental Assistance Demonstration (RAD) Conversion of the existing Rose Hill Courts development to Section 8 Project Based Vouchers from the United States Department of Housing and Urban Development (HUD); (5) Certification of the Environmental Impact Report/Environmental Impact Statement; (6) Haul route approval from the Los Angeles Department of Building and Safety (if required); (7) Permit for removal of street trees from the Los Angeles Board of Public Works (if required); and (8) Other discretionary and ministerial permits and approvals that may be deemed necessary, including, but not limited to, temporary street closure permits, grading permits, excavation permits, foundation permits, building permits, and sign permits in order to execute and implement the Project.
This is to be a combined environmental document, an EIR, prepared under the State of California CEQA (Public Resources Code 21000
The Project involves funding from HUD that qualifies as an “undertaking” subject to the Programmatic Agreement (PA) Among the City of Los Angeles, the California State Historic Preservation Officer, and the Advisory Council on Historic Preservation Regarding Historic Properties Affected by use of Community Development Block Grants; McKinney Act Homeless Programs including the Emergency Shelter Grants Program, Transitional Housing, Permanent Housing for the Homeless Handicapped, and Supplemental Assistance for Facilities to Assist the Homeless; Home Investment Partnership Funds, and the Shelter Plus Care Program for compliance with 36 CFR part 800, the regulations implementing Section 106 of the National Historic Preservation Act. HCID will be initiating the Section 106 consultation process with the SHPO through the PA.
The project proposes the demolition of all 15 buildings at Rose Hill Courts and subsequent construction of 191 affordable public housing units. Rose
The EIR/EIS will discuss the alternatives that were considered for analysis, identify those that were eliminated from further consideration because they do not meet the stated purpose and need, and identify those that will be analyzed further. It is expected that project alternatives will continue to be developed and refined during the public scoping process, with input from the public, agencies, and other stakeholders. The EIR/EIS alternatives analysis will consist of a comparison of the impacts under each alternative pursuant to 24 CFR part 58, in addition to how well each alternative achieves the project's purpose and need. This process, which will be described in detail in the EIR/EIS, will lead to the designation of a Preferred Alternative.
At this time, it is anticipated that the following alternatives will be analyzed: (1) No Project/No Action Alternative; (2) Non-Historically Compliant Rehabilitation Alternative; and (3) Historic Rehabilitation.
1. No Project/No Action Alternative. This alternative would be the continuation of uses on the site; therefore, existing buildings and tenants would remain at the project site and no buildings or uses would be constructed or demolished.
2. Non-Historically Compliant Rehabilitation Alternative. This alternative would redevelop the existing units at Rose Hill Courts but not in a way that would preserve their historic integrity. However, the Non-Historically Compliant Rehabilitation Alternative would retain the existing 100 units on the project site and would not allow for the opportunity to increase the number of affordable housing units on the project site.
3. Historic Rehabilitation. This alternative would redevelop the existing units at Rose Hill Courts in a way that would preserve the historic integrity of the buildings. This alternative would restore the characteristics of the Garden Style design utilized in the Rose Hill Courts development, including but not limited to low-slung buildings, large open spaces, and recreational amenities.
The following subject areas will be analyzed in the combined EIR/EIS for probable environmental effects: Aesthetics, Air Quality, Biological Resources, Cultural Resources, Geology and Soils, Greenhouse Gas Emissions, Hazards and Hazardous Materials, Land Use and Planning, Noise, Population and Housing, Public Services, Recreation, Transportation/Traffic, and Tribal Cultural Resources.
A public scoping meeting will be held from 5:00 p.m. to 7:00 p.m. on October 4, 2018, at the Rose Hill Courts Community Center at 4446 Florizel Street, Los Angeles, California. The scoping process also includes the initiation of the NHPA Section 106 consultation process. We invite comments from all interested parties about the potential impacts this project may have on historic properties, cultural resources, or biological and natural resources as well as the impacts these resources may have on the project. We invite all interested parties to participate in the scoping meeting.
HCID is the responsible entity (RE) and lead agency for this project in accordance with 24 CFR part 58, “Environmental Review Procedures for Entities Assuming HUD Environmental Responsibilities.” As a RE, the HCID assumes the responsibility for environmental review, decision-making, and action that would otherwise apply to HUD under NEPA. Section 26 of the United States Housing Act (42 U.S.C. 1437x) allows units of general local government to assume NEPA responsibilities in projects involving Section 18 demolition/disposition and Section 8 Project-Based Vouchers. The project may use CDBG and HOME funds. If so, Section 104(g) of the Housing and Community Development Act of 1974 (42 U.S.C. 5304(g)) and Section 288 of the HOME Investment Partnerships Act (42 U.S.C. 12838) allow CDBG recipients and HOME jurisdictions, respectively, to assume NEPA responsibilities for CDBG and HOME projects.
In addition, the HACLA is the CEQA lead agency and is responsible for preparing an EIR. Questions may be directed to the individuals named in this notice under the heading
Bureau of Land Management, Interior.
Notice of reinstatement.
As provided for under the Mineral Leasing Act of 1920, as amended, the Bureau of Land Management (BLM) received a petition for reinstatement of competitive oil and gas leases OHES058186, OHES058187, OHES058188, OHES058191, OHES058198, OHES058199, OHES058200, OHES058203, OHES058204, OHES058205, and OHES058213 from Eclipse Resources I, LP for land in Monroe County, Ohio. The lessee filed the petition on time, along with all rentals due since the leases terminated under the law. No leases affecting these lands were issued before the petition was filed. The BLM proposes to reinstate the leases.
Kathy Gunderman, Branch Chief for Fluid Minerals Adjudication, Bureau of Land Management, Eastern States State Office, 20 M Street SE, Suite 950, Washington, DC 20003; phone 202-912-7721; email
Persons who use a telecommunications device for the deaf may call the Federal Relay Service (FRS) at 1-800-877-8339 to contact Kathy Gunderman during normal business hours. The FRS is available 24 hours a day, 7 days a week, to leave a message or question with the above individual. A reply will be sent during normal business hours.
The lessee agreed to the amended lease terms for rentals and royalties at rates of $10 per acre, or fraction thereof, per year and 16
30 U.S.C. 188 (e)(4) and 43 CFR 3108.2-3(b)(2)(v).
Bureau of Land Management, Interior.
Notice.
As provided for under the Mineral Leasing Act of 1920, as amended, the Bureau of Land Management (BLM) received petitions for reinstatement of competitive oil and gas leases WYW-177798, WYW-183048, WYW-183798, WYW- 183807, WYW-183830, WYW-185283, WYW-185588, WYW-185589, WYW-185591, WYW-185593, WYW-185594, WYW-185595, WYW-185596, WYW-185597, WYW-185598, WYW-185599, and WYW-185601 from Southland Royalty Company LLC for land in Carbon and Sweetwater Counties, Wyoming. The lessee filed the petitions on time, along with all rentals due since the leases terminated under the law. No new leases affecting these lands were issued before the petitions were filed. The BLM proposes to reinstate the leases.
Chris Hite, Branch Chief for Fluid Minerals Adjudication, Bureau of Land Management, Wyoming State Office, 5353 Yellowstone Road, P.O. Box 1828, Cheyenne, Wyoming, 82003; phone 307-775-6176; email
Persons who use a telecommunications device for the deaf may call the Federal Relay Service (FRS) at 1-800-877-8339 to contact Mr. Hite during normal business hours. The FRS is available 24 hours a day, 7 days a week, to leave a message or question with the above individual. A reply will be sent during normal business hours.
The lessee agreed to the amended lease terms for rentals and royalties at rates of $10 per acre, or fraction thereof, per year and 16
The lessee met the requirements for reinstatement of the leases per Sec. 31(d) and (e) of the Mineral Leasing Act of 1920 (30 U.S.C. 188). The BLM proposes to reinstate each of the leases effective on the date of termination, under amended terms and conditions including the increased rental and royalty rates cited above.
30 U.S.C. 188(e)(4) and 43 CFR 3108.2-3(b)(2)(v).
On the basis of the record
The Commission instituted this investigation effective October 5, 2017, following receipt of a petition filed with the Commission and Commerce by Bonney Forge Corporation, Mount Union, Pennsylvania, and the United Steel, Paper and Forestry, Rubber, Manufacturing, Energy, Allied Industrial and Service Workers International Union, Pittsburgh, Pennsylvania. The Commission established a general schedule for the final phase of its investigations on forged steel fittings from China, India, and Taiwan
The Commission made this determination pursuant to section 735(b) of the Act (19 U.S.C. 1673d(b)). It completed and filed its determination in this investigation on September 14, 2018. The views of the Commission are contained in USITC Publication 4823 (September 2018), entitled
By order of the Commission.
U.S. International Trade Commission.
Notice.
Notice is hereby given that the U.S. International Trade Commission has determined to grant the private parties' joint motion to terminate the enforcement proceeding based on settlement. The enforcement proceeding is terminated.
Amanda Pitcher Fisherow, Esq., Office of the General Counsel, U.S. International Trade Commission, 500 E Street SW, Washington, DC 20436, telephone (202) 205-2737. 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 the underlying investigation on January 27, 2015, based on a complaint filed on behalf of Cisco Systems, Inc. (“Cisco”) of San Jose, California. 80
On June 23, 2016, the Commission found that a Section 337 violation had occurred as to the '537, '592, and '145 patents and therefore issued a limited exclusion order and a cease and desist order (“CDO”) against Arista. 81
On August 26, 2016, Cisco filed an enforcement complaint alleging that Arista had violated the June 23, 2016 CDO by reason of infringement of the '537 patent. The Commission instituted this enforcement proceeding on October 4, 2016, based on Cisco's complaint. 81
On August 24, 2018, Cisco and Arista filed a joint motion to terminate the enforcement proceeding based on settlement. The motion includes both confidential and public versions of a binding term sheet, and the parties represent that there are no other agreements, written or oral, express or implied between them concerning the subject matter of the proceeding. The parties also contend that the termination of the investigation would not adversely affect the public interest.
The Commission has determined to grant the joint motion. The Commission finds that the private parties have complied with the Commission's Rules, and that termination of the enforcement proceeding would not adversely affect the public interest. The proceeding is terminated.
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.
U.S. International Trade Commission.
Notice.
Notice is hereby given that the U.S. International Trade Commission has received a complaint entitled
Lisa R. Barton, Secretary to the Commission, U.S. International Trade Commission, 500 E Street SW, Washington, DC 20436, telephone (202) 205-2000. The public version of the complaint can be accessed on the Commission's Electronic Document Information System (EDIS) at
General information concerning the Commission may also be obtained by accessing its internet server at United States International Trade Commission (USITC) at
The Commission has received a complaint and a submission pursuant to § 210.8(b) of the Commission's Rules of Practice and Procedure filed on behalf of INVT SPE LLC on September 14, 2018. The complaint alleges violations of section 337 of the Tariff Act of 1930 (19 U.S.C. 1337) in the importation into the United States, the sale for importation, and the sale within the United States after importation of certain LTE- and 3G-compliant cellular communications devices. The complaint names as respondents: Apple Inc. of Cupertino, CA; HTC Corporation of China; HTC America, Inc. of Seattle, Washington;
Proposed respondents, other interested parties, and members of the public are invited to file comments, not to exceed five (5) pages in length, inclusive of attachments, on any public interest issues raised by the complaint or § 210.8(b) filing. Comments should address whether issuance of the relief specifically requested by the complainant in this investigation would affect the public health and welfare in the United States, competitive conditions in the United States economy, the production of like or directly competitive articles in the United States, or United States consumers.
In particular, the Commission is interested in comments that:
(i) Explain how the articles potentially subject to the requested remedial orders are used in the United States;
(ii) identify any public health, safety, or welfare concerns in the United States relating to the requested remedial orders;
(iii) identify like or directly competitive articles that complainant, its licensees, or third parties make in the United States which could replace the subject articles if they were to be excluded;
(iv) indicate whether complainant, complainant's licensees, and/or third party suppliers have the capacity to replace the volume of articles potentially subject to the requested exclusion order and/or a cease and desist order within a commercially reasonable time; and
(v) explain how the requested remedial orders would impact United States consumers.
Written submissions on the public interest must be filed no later than by close of business, eight calendar days after the date of publication of this notice in the
Persons filing written submissions must file the original document electronically on or before the deadlines stated above and submit 8 true paper copies to the Office of the Secretary by noon the next day pursuant to § 210.4(f) of the Commission's Rules of Practice and Procedure (19 CFR 210.4(f)). Submissions should refer to the docket number (“Docket No. 3342”) in a prominent place on the cover page and/or the first page. (
Any person desiring to submit a document to the Commission in confidence must request confidential treatment. All such requests should be directed to the Secretary to the Commission and must include a full statement of the reasons why the Commission should grant such treatment.
This action is taken under the authority of section 337 of the Tariff Act of 1930, as amended (19 U.S.C. 1337), and of §§ 201.10 and 210.8(c) of the Commission's Rules of Practice and Procedure (19 CFR 201.10, 210.8(c)).
By order of the Commission.
Notice is hereby given that, on September 10, 2018, pursuant to Section 6(a) of the National Cooperative Research and Production Act of 1993, 15 U.S.C. 4301
Also, Univision, Teaneck, NJ; SuperSport, Johannesburg, SOUTH AFRICA; Xytech Systems Corporation, Mission Hills, CA; Iain Collins (individual member), London, UNITED KINGDOM; and Keith Ian Graham (individual member), San Jose, CA, have withdrawn as parties to this venture.
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 Advanced Media Workflow Association, Inc. intends to file additional written notifications disclosing all changes in membership.
On March 28, 2000, Advanced Media Workflow Association, Inc. 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 June 22, 2018. A notice was published in the
Notice is hereby given that, on September 4, 2018, 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 PXI Systems intends to file additional written notifications disclosing all changes in membership.
On November 22, 2000, PXI Systems 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 June 14, 2018. A notice was published in the
Employment and Training Administration, Labor.
Notice.
The Department of Labor (DOL), Employment and Training Administration (ETA), is soliciting comments concerning proposed authority to conduct the voluntary information collection request (ICR) titled, “Industry-Recognized Apprenticeship Programs Accrediting Entity Information.” This comment request is part of continuing Departmental efforts to reduce paperwork and respondent burden in accordance with the Paperwork Reduction Act of 1995 (PRA).
Consideration will be given to all written comments received by November 19, 2018.
Comments submitted in response to this notice should be submitted electronically through the Federal eRulemaking Portal at
Submit written comments about, or requests for a copy of, this ICR by mail or courier to the U.S. Department of Labor, Employment and Training Administration, Office of Apprenticeship, Room C-5321, U.S. Department of Labor, 200 Constitution Avenue NW, Washington, DC 20210; or by email:
Comments submitted in response to this comment request will become a matter of public record and will be summarized and included in the request for Office of Management and Budget (OMB) approval of the information collection request. In addition, comments, regardless of the delivery method, will be posted without change on the
Mark Judge by telephone at 202-693-3470 (this is not a toll-free number) or by email at
DOL, as part of its continuing efforts to reduce paperwork and respondent burden, conducts a pre-clearance consultation program to provide the general public and Federal agencies an opportunity to comment on proposed and/or continuing collections of information before submitting them to OMB for final approval. This program helps to ensure requested data can be provided in the desired format, reporting burden (time and financial resources) is minimized, collection instruments are clearly understood, and the impact of collection requirements can be properly assessed.
ETA has requested that OMB approve an Information Collection Request pursuant to the Paperwork Reduction Act. If approved, this request will enable ETA to collect essential data under Training and Employment Notice (TEN) No. 3-18 concerning the operational characteristics of certain industry-recognized apprenticeship programs that are being established under the statutory authority of the Act (located at 29 U.S.C. 50).
On June 15, 2017, President Trump issued Executive Order 13801, entitled “Expanding Apprenticeships in America,” which directed the Secretary of Labor (in consultation with the Secretaries of Education and Commerce)
The Secretary has determined to move forward with the development of the industry-recognized apprenticeship programs contemplated by the foregoing provisions of the Executive Order. To accomplish this goal, the Department issued an interim informational and guidance document (TEN No., 3-18) on July 27, 2018 titled “Creating Industry-Recognized Apprenticeship Programs to Expand Opportunity in America.” According to the TEN, these new industry-recognized apprenticeship programs will be reviewed and recognized by qualified accrediting entities; the accrediting entities, in turn, may request a determination from the Department concerning their qualifications to act as a accreditor. The Department intends to promulgate a regulation amending 29 CFR part 29; this regulation would, among other things, establish guidelines or requirements that qualified entities must follow to ensure that the industry-recognized programs they accredit meet quality standards.
The TEN provides interim information and guidance to accreditors on the process for obtaining a determination from the Department on whether that entity's standards meet the criteria outlined in TEN No. 3-18. To obtain a favorable determination from the Department, the accrediting entity should, among other things, demonstrate that it has received broad sector-wide input and consensus in the setting of industry-wide quality standards. The accrediting entity should also demonstrate that their program accreditation process ensures that the industry programs will operate in a manner consistent with DOL-identified hallmarks of high-quality apprenticeship programs. To collect the information necessary for the Department to determine whether the entity accrediting these industry-recognized apprenticeship programs has satisfied the foregoing criteria, the Department proposes the development of a form titled “Industry-Recognized Apprenticeship Programs Accrediting Entity Information,” intended for completion by the accrediting entity, that will enable the Department to determine whether that entity's standards meet the criteria outlined in the TEN. An electronic version of this information collection form will be posted on the Department's website, and will be capable of being completed and submitted online.
Under the National Apprenticeship Act of 1937, the Secretary of Labor is charged with the establishment of labor standards designed to safeguard the welfare of apprentices and promote apprenticeship opportunity. Pursuant to this statutory authority, and in furtherance of the policy objectives stated in Executive Order 13801, the Secretary has determined that the immediate establishment of industry-recognized apprenticeship programs is a matter of vital national interest. 44 U.S.C. 3506(c)(2)(A) authorizes this information collection.
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 OMB under the PRA approves it 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 provide comments to the contact shown in the
Submitted comments will also be a matter of public record for this ICR and posted on the internet, without redaction. DOL encourages commenters not to include personally identifiable information, confidential business data, or other sensitive statements/information in any comments. DOL is particularly interested in comments that:
• 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,
Office of the Secretary, Bureau of International Labor Affairs, Department of Labor.
Announcement of public availability of updated list of goods.
This notice announces the publication of an updated list of goods—along with countries of origin—that the Bureau of International Labor Affairs (ILAB) has reason to believe are produced by child labor or forced labor in violation of international standards (TVPRA List). ILAB is required to develop and make available to the public the TVPRA List pursuant to the Trafficking Victims Protection Reauthorization Act (TVPRA) of 2005, as amended.
Rachel Rigby, Office of Child Labor, Forced Labor, and Human Trafficking, Bureau of International Labor Affairs, U.S. Department of Labor, at (202) 693-4843 (this is not a toll-free number).
The Bureau of International Labor Affairs (ILAB) announces the publication of the eighth edition of the
Section 105(b) of the TVPRA mandates that ILAB develop and publish a list of goods from countries that ILAB “has reason to believe are produced by forced labor or child labor in violation of international standards.” 22 U.S.C. 7112(b)(2). ILAB's Office of Child Labor, Forced Labor, and Human Trafficking (OCFT) carries out this mandate. The primary purposes of the TVPRA List are to raise public awareness about the incidence of child labor and forced labor in the production of goods in the countries listed and to promote efforts to eliminate such practices. A full report, including the updated TVPRA List and a discussion of the TVPRA List's methodology, as well as Frequently Asked Questions and a bibliography of sources, are available on the Department of Labor website at:
22 U.S.C. 7112(b)(2)(C).
National Aeronautics and Space Administration.
Notice of meeting.
In accordance with the Federal Advisory Committee Act, as amended, the National Aeronautics and Space Administration (NASA) announces a meeting of the Astrophysics Advisory Committee. This Committee reports to the Director, Astrophysics Division, Science Mission Directorate, NASA Headquarters. The meeting will be held for the purpose of soliciting, from the scientific community and other persons, scientific and technical information relevant to program planning.
Monday, October 22, 2018, 11:00 a.m.-5:00 p.m.; and Tuesday, October 23, 2018, 11:00 a.m.-5:00 p.m., Eastern Time.
Ms. KarShelia Henderson, Science Mission Directorate, NASA Headquarters, Washington, DC 20546, (202) 358-2355, fax (202) 358-2779, or
The meeting will be open to the public telephonically and by WebEx. You must use a touch-tone phone to participate in this meeting. Any interested person may dial the USA toll free conference call number 1-888-324-2912 or toll number 1-312-470-7002, passcode 7682264, to participate in this meeting by telephone on both days. The WebEx link is
The agenda for the meeting includes the following topics:
It is imperative that the meeting be held on this date to accommodate the scheduling priorities of the key participants.
National Science Foundation.
Notice of permit applications received.
The National Science Foundation (NSF) is required to publish a notice of permit applications received to conduct activities regulated under the Antarctic Conservation Act of 1978. NSF has published regulations under the Antarctic Conservation Act in the Code of Federal Regulations. This is the required notice of permit applications received.
Interested parties are invited to submit written data, comments, or views with respect to this permit application by October 22, 2018. This application may be inspected by interested parties at the Permit Office, address below.
Comments should be addressed to Permit Office, Office of Polar Programs, National Science Foundation, 2415 Eisenhower Avenue, Alexandria, Virginia 22314.
Nature McGinn, ACA Permit Officer, at the above address, 703-292-8030, or
The National Science Foundation, as directed by the Antarctic Conservation Act of 1978 (Pub. L. 95-541, 45 CFR 670), as amended by the Antarctic Science, Tourism and Conservation Act of 1996, has developed regulations for the establishment of a permit system for various activities in Antarctica and designation of certain animals and certain geographic areas a requiring special protection. The regulations establish such a permit system to designate Antarctic Specially Protected Areas.
Natasja van Gestel, Texas Tech University, Biological Sciences Department, 2901 Main Street, Lubbock, TX 79409.
Caitlin Saks, WGBH, 1 Guest Street, Boston, MA 02135.
In accordance with the Federal Advisory Committee Act (Pub. L. 92-463, as amended), the National Science Foundation (NSF) announces the following meeting:
In accordance with the Federal Advisory Committee Act (Pub. L. 92-463, as amended), the National Science Foundation (NSF) announces the following meeting:
October 19, 2018; 8:00 a.m.-2:00 p.m.
To attend the meeting in person, all visitors must contact the Directorate for Education and Human Resources at least 48 hours prior to the meeting to arrange for a visitor's badge. All visitors
Final agenda can be located on the EHR AC website:
Nuclear Regulatory Commission.
Standard review plan—draft section revision; reopening of comment period.
On July 13, 2018, the U.S. Nuclear Regulatory Commission (NRC) published a request for public comment on draft NUREG-0800, “Standard Review Plan for the Review of Safety Analysis Reports for Nuclear Power Plants: LWR Edition,” Branch Technical Position (BTP) 5-3, “Fracture Toughness Requirements.” The public comment period was originally scheduled to close on September 11, 2018. The NRC has decided to reopen the public comment period on this document for 30 days to allow more time for members of the public to review additional revisions that the NRC made to BTP 5-3 since the draft was issued on July 13, 2018, and to assemble and submit their comments.
The comment period for the document published on July 13, 2018 (83 FR 32690) has been reopened. Comments must be filed no later than October 22, 2018. Comments received after this date will be considered, if it is practical to do so, but the Commission is able to ensure consideration only for comments received on or before this date.
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
Mark D. Notich, Office of New Reactors, telephone: 301-415-3053; email:
Please refer to Docket ID NRC-2018-0145 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-2018-0145 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 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 into ADAMS.
On July 13, 2018 (83 FR 32690), the NRC published a request for public
The public comment period was originally closed on September 11, 2018. The NRC has included additional revisions to the text of BTP 5-3 since the section was issued for comment. Accordingly, the NRC has decided to reopen the public comment period on this document to allow more time for members of the public to assemble and submit their comments. The revised text for BTP 5-3 can be found in ML18254A090. The redline/strikeout comparing the current version of BTP 5-3 and the revised version can be found in ML18257A032.
For the Nuclear Regulatory Commission.
Nuclear Regulatory Commission.
Regulatory guide; withdrawal.
The U.S. Nuclear Regulatory Commission (NRC) is withdrawing Regulatory Guide (RG) 5.68, “Protection against Malevolent use of Vehicles at Nuclear Power Plants,” dated August 1994. This document is being withdrawn because it is outdated and has been superseded by other NRC guidance. Therefore, it no longer provides methods that the NRC staff finds acceptable to protect against the malevolent use of vehicles as a means to gain unauthorized access to protected areas and vital areas and to ensure that these vehicles are operated only by authorized persons with a legitimate need for access.
The effective date of the withdrawal of RG 5.68 is September 20, 2018.
Please refer to Docket ID NRC-2018-0206 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:
•
•
•
Bernard Stapleton, telephone: 301-287-3532, email:
The NRC is withdrawing RG 5.68, “Protection against Malevolent use of Vehicles at Nuclear Power Plants,” because the guidance contained in the document is outdated, has been superseded by new guidance, and therefore is no longer acceptable to meet NRC regulatory requirements. In particular, on March 27, 2009, the NRC issued a revised rule that enhanced the security requirements pertaining to nuclear power plants to incorporate requirements that were issued through Commission orders as a result of the September 11, 2001, terrorist attacks (74 FR 13925). In addition, the rulemaking added several new requirements consistent with insights gained from implementation of the orders, review of site security plans, implementation of the enhanced baseline inspection program, and NRC evaluation of force-on-force exercises. Since RG 5.68 was published in August 1994, it does not account for the updated requirements of 10 CFR part 73. As a result, the guidance in RG 5.68 is outdated. In addition, the NRC is withdrawing RG 5.68 because it has been superseded by updated guidance that can be found in other regulatory documents. These documents provide licensees with acceptable approaches to address various issues, including vehicle access controls, use of explosives, target set identification and the appropriate use of vehicles.
The withdrawal of RG 5.68 does not alter any prior or existing NRC licensing approval or the acceptability of licensee commitments made in accordance with the withdrawn guidance. Although RG 5.68 is withdrawn, current licensees referencing this RG may continue to do so, and withdrawal does not affect any existing licenses or agreements. However, by withdrawing RG 5.68, the NRC will no longer approve use of the guidance in future requests or applications for NRC licensing actions.
For the Nuclear Regulatory Commission.
Nuclear Regulatory Commission.
License renewal and record of decision; issuance.
The U.S. Nuclear Regulatory Commission (NRC) has issued renewed Facility Operating License Nos. DPR-26
The NRC issued the Renewed Facility Operating License Nos. DPR-26 and DPR-64 on September 17, 2018.
Please refer to Docket ID NRC-2008-0672 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:
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William Burton, Office of Nuclear Reactor Regulation, U.S. Nuclear Regulatory Commission, Washington DC 20555-0001; telephone: 301-415-6332, email:
Notice is hereby given that the NRC has issued Renewed Facility Operating License Nos. DPR-26 and DPR-64 to Entergy Nuclear Operations, Inc. (Entergy or licensee), for the Indian Point Nuclear Generating Unit Nos. 2 (IP2) and 3 (IP3). IP2 and IP3 are pressurized-water reactors located in Buchanan, NY (24 miles north of New York City, NY). Renewed Facility Operating License Nos. DPR-26 and DPR-64 authorize the licensee to operate IP2 and IP3 at reactor core power levels not in excess of 3,216 megawatts thermal for each unit, in accordance with the provisions of the IP2 and IP3 renewed licenses and technical specifications. The renewed licenses authorize operation of IP2 and IP3 until April 30, 2024 and April 30, 2025, respectively. The NRC's record of decision (ROD) that supports the NRC's decision to issue Renewed Facility Operating License Nos. DPR-26 and DPR-64 is available in ADAMS under Accession No. ML18212A032.
The NRC has concluded that the application for the renewed licenses, “Indian Point Energy Center License Renewal Application,” dated April 23, 2007 (ADAMS Accession No. ML071210512), as amended, complies with the standards and requirements of the Atomic Energy Act of 1954, as amended (the Act), and the NRC's regulations. As required by the Act and the NRC's regulations set forth in title 10 of the
The NRC staff published its final supplemental environmental impact statement (FSEIS) in five volumes of NUREG-1437, Supplement 38, “Generic Environmental Impact Statement for License Renewal of Nuclear Plants Regarding Indian Point Nuclear Generating Unit Nos. 2 and 3 (NUREG-1437, Supplement 38) Final Report.” For Volumes 1 through 3, dated December 3, 2010, see ADAMS Package Accession No. ML103270072; for Volume 4, dated June 30, 2013 (FSEIS Supplement 1), see ADAMS Accession No. ML13162A616; and for Volume 5, dated April 30, 2018 (FSEIS Supplement 2), see ADAMS Accession No. ML18107A759. As discussed in the ROD, FSEIS, and FSEIS supplements, the NRC has considered the reasonably foreseeable impacts of IP2 and IP3 license renewal as well as a range of reasonable alternatives to license renewal that included natural gas combined-cycle (NGCC); purchased electric power; conservation; combination alternative 1 (license renewal of either IP2 or IP3 along with wind power, hydropower, biomass fuels, landfill-gas fuels, and conservation); combination alternative 2 (fossil-fired power (combined-cycle) with wind power, biomass fuels, hydropower, landfill-gas fuels, and conservation); the no-action alternative; and operation of IP2 and IP3 using cooling towers. The FSEIS and FSEIS supplements document the environmental review, including the determination that the adverse environmental impacts of license renewal for IP2 and IP3 are not so great that preserving the option of license renewal for energy planning decisionmakers would be unreasonable.
The NRC staff documented the results of its safety review in its “Safety Evaluation Report (SER) Related to the License Renewal of Indian Point Nuclear Generating Unit Nos. 2 and 3,” issued August 11, 2009 (ADAMS Accession No. ML092240268). On November 30, 2009, the NRC staff published its final report in two volumes as NUREG-1930, “Safety Evaluation Report Related to the License Renewal of Indian Point Nuclear Generating Unit Nos. 2 and 3” (for Volume 1, see ADAMS Accession No. ML093170451 and for Volume 2 see ADAMS Accession No. ML093170671). On August 31, 2011, the NRC staff issued Supplement 1 to NUREG-1930 (ADAMS Accession No. ML11242A215). Supplement 1 documents the NRC staff's review of supplemental information provided by the applicant since the issuance of NUREG-1930, including annual updates required by 10 CFR 54.21(b), and updated information and commitments in response to NRC staff requests for additional information. On July 31, 2015, the NRC staff issued Supplement 2 to NUREG-1930 (ADAMS Accession No. ML15188A383). Supplement 2 documents the NRC staff's review of supplemental information provided by the applicant since the issuance of Supplement 1, including information committed to by Entergy as documented in Commitment No. 30 (pertaining to reactor vessel internals), annual updates required by 10 CFR 54.21(b), updated information and commitments, as well as information provided in response to NRC staff requests for additional information. On August 1, 2018, the NRC staff issued Supplement 3 to NUREG-1930 (ADAMS Accession No.
The NRC has determined that the application for the Indian Point Nuclear Generating Unit Nos. 2 and 3 renewed licenses, “Indian Point Energy Center License Renewal Application,” dated April 23, 2007, as amended, complies with the standards and requirements of the Atomic Energy Act of 1954, as amended (the Act), and the NRC's regulations. As required by the Act and the NRC's regulations in 10 CFR, the NRC has made appropriate findings, which are set forth in the renewed licenses and the ROD. No adjudicatory matters are pending before the Commission or the Atomic Safety and Licensing Board regarding the IP2 and IP3 license renewal application.
Accordingly, the NRC has issued Renewed Facility Operating License Nos. DPR-26 and DPR-64, authorizing operation of IP2 and IP3 until April 30, 2024 and April 30, 2025, respectively.
The documents identified in the following table are available to interested persons as indicated.
For the Nuclear Regulatory Commission.
Postal Regulatory Commission.
Notice.
The Commission is noticing a recent Postal Service filing for the Commission's consideration concerning negotiated service agreements. This notice informs the public of the filing, invites public comment, and takes other administrative steps.
Submit comments electronically via the Commission's Filing Online system at
David A. Trissell, General Counsel, at 202-789-6820.
The Commission gives notice that the Postal Service filed request(s) for the Commission to consider matters related to negotiated service agreement(s). The request(s) may propose the addition or removal of a negotiated service agreement from the market dominant or the competitive product list, or the modification of an existing product currently appearing on the market dominant or the competitive product list.
Section II identifies the docket number(s) associated with each Postal Service request, the title of each Postal Service request, the request's acceptance date, and the authority cited by the Postal Service for each request. For each request, the Commission appoints an officer of the Commission to represent the interests of the general public in the proceeding, pursuant to 39 U.S.C. 505 (Public Representative). Section II also establishes comment deadline(s) pertaining to each request.
The public portions of the Postal Service's request(s) can be accessed via the Commission's website (
The Commission invites comments on whether the Postal Service's request(s)
1.
2.
This Notice will be published in the
Tuesday, September 11, 2018, at 8:30 a.m. and Wednesday, September 12, 2018, at 8:30 a.m.
Washington, DC.
Closed.
1. Strategic Items.
2. Executive Session.
1. Strategic Items.
2. Financial Matters.
3. Executive Session.
Michael J. Elston, Acting Secretary of the Board, U.S. Postal Service, 475 L'Enfant Plaza SW, Washington, DC 20260-1000. Telephone: (202) 268-4800.
Postal Service
Notice.
The Postal Service gives notice of filing a request with the Postal Regulatory Commission to add a domestic shipping services contract to the list of Negotiated Service Agreements in the Mail Classification Schedule's Competitive Products List.
Elizabeth Reed, 202-268-3179.
The United States Postal Service® hereby gives notice that, pursuant to 39 U.S.C. 3642 and 3632(b)(3), on September 14, 2018, it filed with the Postal Regulatory Commission a
The Presidio Trust.
Notice of public meeting.
In accordance with the Presidio Trust Act, and in accordance with the Presidio Trust's bylaws, notice is hereby given that a public meeting of the Presidio Trust Board of Directors will be held commencing 5:00 p.m. on October 18, 2018, at the Officers' Club, 50 Moraga Avenue, Presidio of San Francisco, California.
The purposes of this meeting are to: Provide the Board Chair's report; provide the Chief Executive Officer's report; hold a National Environmental Policy Act scoping workshop for the Fort Winfield Scott project; and receive public comment on these and other matters pertaining to Trust business.
Individuals requiring special accommodation at this meeting, such as needing a sign language interpreter, should contact Mollie Matull at 415.561.5300 prior to October 9, 2018.
The meeting will begin at 5:00 p.m. on October 18, 2018.
The meeting will be held at the Officers' Club, 50 Moraga Avenue, Presidio of San Francisco.
Nancy J. Koch, General Counsel, the Presidio Trust, 103 Montgomery Street, P.O. Box 29052, San Francisco, California 94129-0052, Telephone: 415.561.5300.
Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (the “Act”),
Cboe C2 Exchange, Inc. (the “Exchange” or “C2”) proposes to amend its rules relating to categories of registration and respective qualification examinations required for Trading Permit Holders (“TPHs”) and associated persons that engage in trading activities on the Exchange.
The text of the proposed rule change is also available on the Exchange's website (
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.
The SEC recently approved a proposed rule change to restructure the FINRA representative-level qualification examination program.
The SIE would assess basic product knowledge; the structure and function of the securities industry markets, regulatory agencies and their functions; and regulated and prohibited practices. In particular, the SIE will cover four major areas. The first, “Knowledge of Capital Markets,” focuses on topics such as types of markets and offerings, broker-dealers and depositories, and economic cycles. The second, “Understanding Products and Their Risks,” covers securities products at a high level as well as associated investment risks. The third, “Understanding Trading, Customer Accounts and Prohibited Activities,” focuses on accounts, orders, settlement and prohibited activities. The final area, “Overview of the Regulatory Framework,” encompasses topics such as SROs, registration requirements and specified conduct rules. It's anticipated that the SIE would include 75 scored questions plus an additional 10 unscored pretest questions. The passing score would be determined through methodologies compliant with testing industry standards used to develop examinations and set passing standards.
The restructured program eliminates duplicative testing of general securities knowledge on the current representative-level qualification examinations by moving such content into the SIE. The SIE will test fundamental securities related knowledge, including knowledge of basic products, the structure and function of the securities industry, the regulatory agencies and their functions and regulated and prohibited practices, whereas the revised representative-level qualification examinations will test knowledge relevant to day-to-day activities, responsibilities and job functions of representatives. The SIE was developed in consultation with a committee of industry representatives and representatives of several other SROs. Each of the current representative-level examinations covers general securities knowledge, with the exception of the Research Analyst (Series 86 and 87) examinations.
The Exchange proposes to require that effective October 1, 2018, new applicants seeking to register in a representative capacity with the Exchange must pass the SIE before their registrations can become effective. The Exchange proposes to make the requirement operative on October 1, 2018 to coincide with the effective date of FINRA's requirement.
The Exchange notes that individuals who are registered as of October 1, 2018 are eligible to maintain their registrations without being subject to any additional requirements. Individuals who had been registered within the past two years prior to October 1, 2018, would also be eligible to maintain those registrations without being subject to any additional requirements, provided they register within two years from the date of their last registration. However, with respect to an individual who is not registered on the effective date of the proposed rule change but was registered within the past two years prior to the effective date of the proposed rule change, the individual's SIE status in the CRD system would be administratively terminated if such individual does not register with the Exchange within four years from the date of the individual's last registration. The Exchange also notes that consistent with Interpretation and Policy .04 of Rule 3.4, the Exchange will consider waivers of the SIE alone or the SIE and the representative or principal-level examination(s) for TPHs who are seeking registration in a representative- or principal-level registration category.
Lastly, the Exchange proposes to adopt Interpretation and Policy .08 of Rule 3.4 to provide individuals who are associated persons of firms and who hold foreign registrations an alternative, more flexible, process to obtain an Exchange representative-level registration.
The Exchange believes the proposed rule change is consistent with the Securities Exchange Act of 1934 (the “Act”) and the rules and regulations thereunder applicable to the Exchange and, in particular, the requirements of Section 6(b) of the Act.
The Exchange believes that the proposed rule change will improve the efficiency of the Exchange's examination requirements, without compromising the qualification standards, by eliminating duplicative testing of general securities knowledge on examinations. FINRA has indicated that the SIE was developed in an effort to adopt an examination that would assess basic product knowledge; the structure and function of the securities industry markets, regulatory agencies and their functions; and regulated and prohibited practices. The Exchange also notes that the introduction of the SIE and expansion of the pool of individuals who are eligible to take the SIE, has the potential of enhancing the pool of prospective securities industry professionals by introducing them to securities laws, rules and regulations and appropriate conduct before they join the industry in a registered capacity. Lastly, the Exchange notes adopting the SIE requirement is consistent with the requirement recently adopted by FINRA.
The Exchange does not believe that the proposed rule change will impose any burden on competition that is not necessary or appropriate in furtherance of the purposes of the Act. The Exchange believes that the proposed rule change, which harmonizes its rules with recent rule changes adopted by FINRA and which is being filed in conjunction with similar filings by the other national securities exchanges, will reduce the regulatory burden placed on market participants engaged in trading activities across different markets. The Exchange believes that the harmonization of these registration requirements across the various markets will reduce burdens on competition by removing impediments to participation in the national market system and promoting competition among participants across the multiple national securities exchanges.
The Exchange neither solicited nor received written comments on the proposed rule change.
Because the foregoing proposed rule change does not: (i) Significantly affect the protection of investors or the public interest; (ii) impose any significant burden on competition; and (iii) become operative for 30 days from the date on which it was filed, or such shorter time as the Commission may designate, it has become effective pursuant to Section 19(b)(3)(A) of the Act
A proposed rule change filed under Rule 19b-4(f)(6) normally does not become operative for 30 days from the date of filing. However, Rule 19b-4(f)(6)(iii)
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 necessary or appropriate in the public interest, for the protection of investors, or otherwise in furtherance of the purposes 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 July 11, 2018, NYSE Arca, Inc. (“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 finds it appropriate to designate a longer period within which to take action on the proposed rule change so that it has sufficient time to consider the proposed rule change. Accordingly, the Commission, pursuant to Section 19(b)(2) 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 is proposing to amend its rules relating to categories of registration and respective qualification examinations required for Members that engage in trading activities on the Exchange.
The text of the proposed rule change is available at the Exchange's website 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 SEC recently approved a proposed rule change to restructure the FINRA representative-level qualification examination program.
The SIE would assess basic product knowledge; the structure and function of the securities industry markets, regulatory agencies and their functions; and regulated and prohibited practices. In particular, the SIE will cover four major areas. The first, “Knowledge of Capital Markets,” focuses on topics such as types of markets and offerings, broker-dealers and depositories, and economic cycles. The second, “Understanding Products and Their Risks,” covers securities products at a high level as well as associated investment risks. The third, “Understanding Trading, Customer Accounts and Prohibited Activities,” focuses on accounts, orders, settlement and prohibited activities. The final area, “Overview of the Regulatory Framework,” encompasses topics such as SROs, registration requirements and specified conduct rules. It's anticipated that the SIE would include 75 scored questions plus an additional 10 unscored pretest questions. The passing score would be determined through methodologies compliant with testing industry standards used to develop examinations and set passing standards.
The restructured program eliminates duplicative testing of general securities knowledge on the current representative-level qualification examinations by moving such content into the SIE. The SIE will test fundamental securities related knowledge, including knowledge of basic products, the structure and function of the securities industry, the regulatory agencies and their functions and regulated and prohibited practices, whereas the revised representative-level qualification examinations will test knowledge relevant to day-to-day activities, responsibilities and job functions of representatives. The SIE was developed in consultation with a committee of industry representatives and representatives of several other SROs. Each of the current representative-level examinations covers general securities knowledge, with the exception of the Research Analyst (Series 86 and 87) examinations.
The Exchange proposes to require that effective October 1, 2018, new applicants seeking to register in a representative capacity with the Exchange must pass the SIE examination [sic] before their registrations can become effective. The Exchange proposes to make the requirement operative on October 1, 2018 to coincide with the effective date of FINRA's requirement.
The Exchange notes that individuals who are registered as of October 1, 2018 are eligible to maintain their registrations without being subject to any additional requirements. Individuals who had been registered within the past two years prior to October 1, 2018, would also be eligible to maintain those registrations without being subject to any additional requirements, provided they register within two years from the date of their last registration. However, with respect to an individual who is not registered on the effective date of the proposed rule change but was registered within the past two years prior to the effective date of the proposed rule change, the individual's SIE status in the CRD system would be administratively terminated if such individual does not register with the Exchange within four years from the date of the individual's last registration. The Exchange also notes that consistent with Interpretation and Policy .01(b) of Rule 2.5, the Exchange will consider waivers of the SIE alone or the SIE and the representative or principal-level examination(s) for Members who are seeking registration in a representative- or principal-level registration category.
Lastly, the Exchange proposes to eliminate references in its rules to alternative foreign examination modules, along with specific references to the Series 17, 37 and 38 examinations. Particularly, the Exchange notes that FINRA recently announced it was eliminating the United Kingdom Securities Representative and the Canadian Securities Representative registration categories, along with the respective associated exams (
The Exchange believes the proposed rule change is consistent with the Securities Exchange Act of 1934 (the “Act”) and the rules and regulations thereunder applicable to the Exchange and, in particular, the requirements of Section 6(b) of the Act.
The Exchange believes that the proposed rule change will improve the efficiency of the Exchange's examination requirements, without compromising the qualification standards, by eliminating duplicative testing of general securities knowledge on examinations. FINRA has indicated that the SIE was developed in an effort to adopt an examination that would assess basic product knowledge; the structure and function of the securities industry markets, regulatory agencies and their functions; and regulated and prohibited practices. The Exchange also notes that the introduction of the SIE and expansion of the pool of individuals who are eligible to take the SIE, has the potential of enhancing the pool of prospective securities industry professionals by introducing them to securities laws, rules and regulations and appropriate conduct before they join the industry in a registered capacity. Lastly, the Exchange notes adopting the SIE requirement is consistent with the requirement recently adopted by FINRA.
The Exchange does not believe that the proposed rule change will impose any burden on competition that is not necessary or appropriate in furtherance of the purposes of the Act. The Exchange believes that the proposed rule change, which harmonizes its rules with recent rule changes adopted by FINRA and which is being filed in conjunction with similar filings by the other national securities exchanges, will reduce the regulatory burden placed on market participants engaged in trading activities across different markets. The Exchange believes that the harmonization of these registration requirements across the various markets will reduce burdens on competition by removing impediments to participation in the national market system and promoting competition among participants across the multiple national securities exchanges.
The Exchange has neither solicited nor received written comments on the proposed rule change.
Because the foregoing proposed rule change does not: (i) Significantly affect the protection of investors or the public interest; (ii) impose any significant burden on competition; and (iii) become operative for 30 days from the date on which it was filed, or such shorter time as the Commission may designate, it has become effective pursuant to Section 19(b)(3)(A) of the Act
A proposed rule change filed under Rule 19b-4(f)(6) normally does not become operative for 30 days from the date of filing. However, Rule 19b-4(f)(6)(iii)
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 necessary or appropriate in the public interest, for the protection of investors, or otherwise in furtherance of the purposes of the Act.
Interested persons are invited to submit written data, views and arguments concerning the foregoing, including whether the proposal 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.
Securities and Exchange Commission (“Commission”).
Notice.
Notice of application for an order under Section 3(b)(2) of the Investment Company Act of 1940 (“Act”).
Secretary, Securities and Exchange Commission, 100 F Street NE, Washington, DC 20549-1090. Applicant, 441 Charmany Drive, Madison, Wisconsin 53719.
Rochelle Kauffman Plesset, Senior Counsel, at (202) 551-6840, or Nadya B. Roytblat, Assistant Chief Counsel, 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 website by searching for the file number, or applicant using the Company name box, at
1. Formed in 1995, Applicant is a Delaware corporation that is in the business of developing, clinical testing, marketing and commercializing cancer and pre-cancer screening and diagnostic tests. Applicant currently manufactures a non-invasive, patient-friendly screening test called Cologuard and provides it to patients on a prescription-only basis through its clinical laboratory. Applicant is also currently working on the development of additional tests for other types of cancers.
2. Applicant states that companies in the heathcare sector such as itself generally need significant liquid capital to finance their operations and meet high production, commercialization and regulatory costs. Such companies often spend a significant proportion of their revenues on research and development (“R&D”) in order to bring a product to market and to bring products through the Food and Drug Administration's (“FDA”) approval process.
3. Applicant states that it currently depends on raised capital to finance operations and continued growth but ultimately seeks to generate cash from its operations to support its business. Applicant states that it has successfully raised capital to finance its operations and commercialization of Cologuard in large part through various public offerings of its debt and equity securities. Applicant seeks to preserve its capital and maintain liquidity, pending the use of such capital to support its business operations, by investing in short-term investment grade and liquid fixed income and money market instruments that earn competitive market returns and provide a low level of credit risk (“Capital Preservation Investments”). Applicant also, to a limited extent, makes strategic investments in companies that are complementary to its core business. Applicant's board of directors oversees Applicant's investment practices and defines the parameters for investment activities. Applicant does not invest in securities for short-term speculative purposes.
1. Applicant seeks an order under Section 3(b)(2) of the Act declaring that it is primarily engaged in a business other than that of investing, reinvesting, owning, holding or trading in securities and therefore is not an investment company as defined in the Act.
2. Section 3(a)(l)(A) of the Act defines the term “investment company” to include an issuer that is or holds itself out as being engaged primarily, or proposes to engage primarily, in the business of investing, reinvesting or trading in securities. Section 3(a)(l)(C) of the Act further defines an investment company as an issuer that is engaged or proposes to engage in the business of investing, reinvesting, owning, holding or trading in securities, and owns or proposes to acquire investment securities having a value in excess of 40% of the value of the issuer's total assets (exclusive of Government securities and cash items) on an unconsolidated basis. Section 3(a)(2) of the Act defines “investment securities” to include all securities except Government securities, securities issued by employees' securities companies, and securities issued by majority-owned subsidiaries of the owner which (a) are not investment companies and (b) are not relying on the exclusions from the definition of investment company in Section 3(c)(1) or Section 3(c)(7) of the Act. While Applicant states that it does not hold itself out as being engaged primarily in the business of investing, reinvesting or trading in securities, Applicant states that it consistently holds investment securities that exceed 40% of its total assets on an unconsolidated basis (exclusive of Government securities and cash items). Applicant states that it therefore falls within the definition of investment company under Section 3(a)(l)(C) of the Act.
3. Rule 3a-8 under the Act provides an exclusion from the definition of investment company if, among other factors, a company's R&D expenses are a substantial percentage of its total expenses for the last four fiscal quarters combined. While Applicant believes that it complies with the conditions of Rule 3a-8, Applicant is concerned that its R&D expenses, while substantial in absolute terms, may not be substantial as a ratio of overall expenses, particularly given the expense increase in connection with the commercialization of Cologuard. Applicant's R&D expenses as a ratio of
4. Section 3(b)(2) of the Act provides that, notwithstanding Section 3(a)(l)(C) of the Act, the Commission may issue an order declaring an issuer to be primarily engaged in a business other than that of investing, reinvesting, owning, holding, or trading in securities directly, through majority-owned subsidiaries, or controlled companies conducting similar types of businesses. Applicant requests an order under Section 3(b)(2) of the Act declaring that it is primarily engaged in a business other than that of investing, reinvesting, owning, holding or trading in securities, and therefore is not an investment company as defined in the Act.
5. In determining whether an issuer is “primarily engaged” in a non-investment company business under Section 3(b)(2) of the Act, the Commission considers the following factors: (a) The company's historical development, (b) its public representations of policy, (c) the activities of its officers and directors, (d) the nature of its present assets, and (e) the sources of its present income.
6. Applicant submits that it satisfies the criteria for issuance of an order under Section 3(b)(2) of the Act because Applicant is primarily engaged in the business of developing, testing, marketing and commercializing cancer and pre-cancer diagnostic screening tests and not in the business of investing, reinvesting, owning, holding or trading in securities.
a.
b.
c.
d.
e.
Applicant states that, particularly given its commercialization of Cologuard, a review of its current sources of revenues provides a more accurate picture of its operating company status. Applicant states that, for the year ended December 31, 2017, Applicant had approximately $266 million of revenues attributable to Cologuard. For the three months ended March 31, 2018, Cologuard revenues were approximately $90.3 million. In contrast, Applicant earned $3.9 million in net investment income in 2017, and $3.7 million for the three months ended March 31, 2018, all derived from Capital Preservation Investments.
7. Applicant asserts that its historical development, its public representations of policy, the activities of its officers and directors, the nature of its assets and its sources of income and revenue, as discussed in the application, demonstrate that it is engaged primarily in a business other than that of investing, reinvesting, owning, holding or trading securities. Applicant thus asserts that it satisfies the criteria for issuing an order under Section 3(b)(2) of the Act.
Applicant agrees that any order granted pursuant to the application will be subject to the following conditions:
1. Applicant will continue to allocate and use its accumulated cash and investment securities for bona fide business purposes; and
2. Applicant will refrain from investing or trading in securities for short-term speculative purposes.
For the Commission, by the Division of Investment Management, under delegated authority.
On March 5, 2018, Cboe BZX Exchange, Inc. (“Exchange” or “BZX”) filed with the Securities and Exchange Commission (“Commission”), pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (“Act”)
The Exchange proposes to list and trade the Shares under Exchange Rule 14.11(i), which governs the listing and trading of Managed Fund Shares. The Funds are a series of, and the Shares will be offered by, the Trust.
According to the Exchange, each Fund seeks to provide investment results that correspond generally, before fees and expenses, to the price and yield performance of a particular American Depositary Receipt, hedged against
According to the Exchange, each Fund will hold only: (i) Shares of an American Depositary Receipt (“Unhedged ADR”) listed on a U.S. national securities exchange; (ii) OTC currency swaps that hedge against fluctuations in the exchange rate between the U.S. dollar and the Local Currency (“Currency Hedge”); and (iii) cash and cash equivalents.
The Trust is required to comply with Rule 10A-3 under the Act
According to the Exchange, the Funds will provide investors with the opportunity to easily eliminate currency exposure that they may not even realize exists with Unhedged ADRs without having to transact in the currency derivatives market. The Exchange believes that this would confer a significant benefit to investors and the broader marketplace by adding transparency and simplifying the process of eliminating risk from an investor's portfolio.
The Exchange believes that while the Funds would not meet the generic listing standards for Managed Fund Shares (“Generic Listing Standards”), in particular Exchange Rules 14.11(i)(4)(C)(i)(a)(3)-(4)
After careful review, the Commission finds that the Exchange's proposal to list and trade the Shares, as modified by Amendment No. 3, is consistent with the Act and the rules and regulations thereunder applicable to a national securities exchange.
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 further 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. Trading in the Shares may be halted for market conditions or for reasons that, in the view of the Exchange, make trading inadvisable. The Exchange will also halt trading in a Fund where a market-wide trading halt is declared in the associated Unhedged ADR, and trading in the Fund will remain halted until trading in the Unhedged ADR resumes.
In addition, the Exchange represents that the Adviser is not a registered broker-dealer and is not affiliated with a broker-dealer.
Trading in the Shares will be subject to the Exchange's surveillance procedures, which are adequate to properly monitor the trading of the Shares on the Exchange during all trading sessions and to deter and detect violations of Exchange rules and the applicable federal securities laws. The Exchange represents that trading in the Shares will be subject to the Exchange's existing rules governing the trading of equity securities.
All Unhedged ADRs will be listed on a U.S. national securities exchange, all of which are members of the Intermarket Surveillance Group (“ISG”) or are exchanges with which the Exchange has in place a comprehensive surveillance
The Exchange represents that it deems the Shares to be equity securities, thus rendering trading in the Shares subject to the Exchange's existing rules governing the trading of equity securities. In support of this proposal, the Exchange has made the following representations:
(1) The Exchange has appropriate rules to facilitate transactions in the Shares during all trading sessions.
(2) Trading of the Shares through the Exchange will be subject to the Exchange's surveillance procedures for derivative products, including Managed Fund Shares, and these procedures are adequate to properly monitor the trading of the Shares on the Exchange during all trading sessions and to deter and detect violations of Exchange rules and the applicable federal securities laws.
(3) Each of the Funds will hold only: (i) Shares of an Unhedged ADR listed on a U.S. national securities exchange; (ii) OTC currency swaps that hedge against fluctuations in the exchange rate between the U.S. dollar and the Local Currency; and (iii) cash and cash equivalents.
(4) The U.S. national securities exchanges on which the Unhedged ADRs will be listed are members of ISG or are exchanges with which the Exchange has in place a comprehensive surveillance sharing agreement. The Exchange may obtain information regarding trading in the Funds and Unhedged ADRs held by each Fund via the ISG, from other exchanges that are members or affiliates of the ISG, or with which the Exchange has entered into a comprehensive surveillance sharing agreement. Additionally, the Exchange or FINRA, on behalf of the Exchange, are able to access, as needed, trade information for certain fixed income instruments reported to TRACE.
(5) The Funds will attempt to limit counterparty risk in OTC currency swaps by: (i) Entering into such contracts only with counterparties the Advisor believes are creditworthy; (ii) limiting a Fund's exposure to each counterparty; and (iii) monitoring the creditworthiness of each counterparty and the Fund's exposure to each counterparty on an ongoing basis.
(6) Other than Exchange Rules 14.11(i)(4)(C)(i)(a)(3)-(4) and 14.11(i)(4)(C)(v), the Shares of each Fund will meet and be subject to all requirements of the Generic Listing Standards and other applicable continued listing requirements for Managed Fund Shares under Exchange Rule 14.11(i), such as the listing requirements regarding the Disclosed Portfolio (including the requirement that the Disclosed Portfolio and NAV will be made available to all market participants at the same time); and the requirements regarding intraday indicative value, suspension of trading or removal, trading halts, disclosure, firewalls, and surveillance.
(7) Prior to the commencement of trading, the Exchange will inform its members in an Information Circular of the special characteristics and risks associated with trading the Shares. Specifically, the Information Circular will discuss the following: (i) The procedures for purchases and redemptions of Shares in Creation Units (and that Shares are not individually redeemable); (ii) Exchange Rule 3.7, which imposes suitability obligations on Exchange members with respect to recommending transactions in the Shares to customers; (iii) how information regarding the intraday indicative value and Disclosed Portfolio is disseminated; (iv) the risks involved in trading the Shares during the Pre-Opening and After Hours Trading Sessions when an updated intraday indicative value will not be calculated or publicly disseminated; (v) the requirement that members deliver a prospectus to investors purchasing newly issued Shares prior to or concurrently with the confirmation of a transaction; and (vi) trading information.
(8) The Exchange will suspend trading and commence delisting proceedings pursuant to Exchange Rule 14.12 for a Fund if the Unhedged ADR held by a Fund has been suspended from trading or delisted by the Unhedged ADR's listing exchange.
(9) The Trust is required to comply with Rule 10A-3 under the Act
(10) A minimum of 100,000 Shares for each Fund will be outstanding at the commencement of trading on the Exchange.
In addition, the Exchange represents that all statements and representations made in this filing regarding the description of the portfolio or reference assets, limitations on portfolio holdings or reference assets, dissemination and availability of reference assets and intraday indicative values, and the applicability of Exchange listing rules specified in this filing shall constitute continued listing requirements for the Funds. In addition, the Trust, on behalf of the Funds, has represented to the Exchange that it will advise the Exchange of any failure by a Fund or the Shares to comply with the continued listing requirements, and, pursuant to its obligations under Section 19(g)(1) of the Act, the Exchange will surveil for compliance with the continued listing requirements. If a Fund or the Shares are not in compliance with the applicable listing requirements, the Exchange will commence delisting procedures under Exchange Rule 14.12.
This approval order is based on all of the Exchange's representations, including those set forth above and in Amendment No. 3. For the foregoing reasons, the Commission finds that the proposed rule change, as modified by Amendment No. 3, 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”),
Cboe Exchange, Inc. (the “Exchange” or “Cboe Options”) proposes to amend its rules relating to categories of registration and respective qualification examinations required for Trading Permit Holders (“TPHs”) and associated persons that engage in trading activities on the Exchange.
The text of the proposed rule change is also available on the Exchange's website (
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.
The SEC recently approved a proposed rule change to restructure the FINRA representative-level qualification examination program.
The SIE would assess basic product knowledge; the structure and function of the securities industry markets, regulatory agencies and their functions; and regulated and prohibited practices. In particular, the SIE will cover four major areas. The first, “Knowledge of Capital Markets,” focuses on topics such as types of markets and offerings, broker-dealers and depositories, and economic cycles. The second, “Understanding Products and Their Risks,” covers securities products at a high level as well as associated investment risks. The third, “Understanding Trading, Customer Accounts and Prohibited Activities,” focuses on accounts, orders, settlement and prohibited activities. The final area, “Overview of the Regulatory Framework,” encompasses topics such as SROs, registration requirements and specified conduct rules. It's anticipated that the SIE would include 75 scored questions plus an additional 10 unscored pretest questions. The passing score would be determined through methodologies compliant with testing industry standards used to develop examinations and set passing standards.
The restructured program eliminates duplicative testing of general securities knowledge on the current representative-level qualification examinations by moving such content into the SIE. The SIE will test fundamental securities related knowledge, including knowledge of basic products, the structure and function of the securities industry, the regulatory agencies and their functions and regulated and prohibited practices, whereas the revised representative-level qualification examinations will test knowledge relevant to day-to-day activities, responsibilities and job functions of representatives. The SIE was developed in consultation with a committee of industry representatives and representatives of several other SROs. Each of the current representative-level examinations covers general securities knowledge, with the exception of the Research Analyst (Series 86 and 87) examinations.
The Exchange proposes to require that effective October 1, 2018, new applicants seeking to register in a representative capacity with the Exchange must pass the SIE before their registrations can become effective. The Exchange proposes to make the requirement operative on October 1, 2018 to coincide with the effective date of FINRA's requirement.
The Exchange notes that individuals who are registered as of October 1, 2018 are eligible to maintain their registrations without being subject to any additional requirements. Individuals who had been registered within the past two years prior to October 1, 2018, would also be eligible to maintain those registrations without being subject to any additional requirements, provided they register within two years from the date of their last registration. However, with respect to an individual who is not registered on the effective date of the proposed rule change but was registered within the past two years prior to the effective date of the proposed rule change, the individual's SIE status in the CRD system would be administratively terminated if such individual does not register with the Exchange within four years from the date of the individual's last registration. The Exchange also notes that consistent with Interpretation and Policy .05 of Rule 3.6A, the Exchange will consider waivers of the SIE alone or the SIE and the representative or principal-level examination(s) for TPHs who are
Lastly, the Exchange proposes to adopt Interpretation and Policy .09 of Rule 3.6A and Interpretation and Policy .02 of Rule 9.3 to provide individuals who are associated persons of firms and who hold foreign registrations an alternative, more flexible, process to obtain an Exchange representative-level registration. The Exchange believes that there is sufficient overlap between the SIE and these foreign qualification requirements to permit them to act as exemptions to the SIE. As such the Exchange proposes to provide that individuals who are in good standing as representatives with the Financial Conduct Authority in the United Kingdom or with a Canadian stock exchange or securities regulator would be exempt from the requirement to pass the SIE, and thus would be required only to pass a specialized knowledge examination to register with the Exchange as a representative. The proposed approach would provide individuals with a United Kingdom or Canadian qualification more flexibility to obtain an Exchange representative-level registration. The Exchange notes that FINRA has adopted a similar rule.
The Exchange believes the proposed rule change is consistent with the Securities Exchange Act of 1934 (the “Act”) and the rules and regulations thereunder applicable to the Exchange and, in particular, the requirements of Section 6(b) of the Act.
The Exchange believes that the proposed rule change will improve the efficiency of the Exchange's examination requirements, without compromising the qualification standards, by eliminating duplicative testing of general securities knowledge on examinations. FINRA has indicated that the SIE was developed in an effort to adopt an examination that would assess basic product knowledge; the structure and function of the securities industry markets, regulatory agencies and their functions; and regulated and prohibited practices. The Exchange also notes that the introduction of the SIE and expansion of the pool of individuals who are eligible to take the SIE, has the potential of enhancing the pool of prospective securities industry professionals by introducing them to securities laws, rules and regulations and appropriate conduct before they join the industry in a registered capacity. Lastly, the Exchange notes adopting the SIE requirement is consistent with the requirement recently adopted by FINRA.
The Exchange does not believe that the proposed rule change will impose any burden on competition that is not necessary or appropriate in furtherance of the purposes of the Act. The Exchange believes that the proposed rule change, which harmonizes its rules with recent rule changes adopted by FINRA and which is being filed in conjunction with similar filings by the other national securities exchanges, will reduce the regulatory burden placed on market participants engaged in trading activities across different markets. The Exchange believes that the harmonization of these registration requirements across the various markets will reduce burdens on competition by removing impediments to participation in the national market system and promoting competition among participants across the multiple national securities exchanges.
The Exchange neither solicited nor received written comments on the proposed rule change.
Because the foregoing proposed rule change does not: (i) Significantly affect the protection of investors or the public interest; (ii) impose any significant burden on competition; and (iii) become operative for 30 days from the date on which it was filed, or such shorter time as the Commission may designate, it has become effective pursuant to Section 19(b)(3)(A) of the Act
A proposed rule change filed under Rule 19b-4(f)(6) normally does not become operative for 30 days from the date of filing. However, Rule 19b-4(f)(6)(iii)
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 necessary or appropriate in the public interest, for the protection of investors, or otherwise in furtherance of the purposes of the Act.
Interested persons are invited to submit written data, views, and arguments concerning the foregoing,
• 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 June 13, 2018, ICE Clear Credit LLC (“ICC”) filed with the Securities and Exchange Commission (“Commission”), pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
The proposed rule change will provide the basis for ICC to clear an additional credit default swap contract. ICC proposes to amend Subchapter 26D of its Rules to provide for the clearance of an additional EM Contract, the Lebanese Republic. ICC represents that this additional EM Contract has terms consistent with the other EM Contracts approved for clearing at ICC and is governed by Subchapter 26D of the Rules.
Section 19(b)(2)(C) of the Act directs the Commission to approve a proposed rule change of a self-regulatory organization if it finds that such proposed rule change is consistent with the requirements of the Act and the rules and regulations thereunder applicable to such organization.
The Commission finds that the rule change is consistent with Section 17A(b)(3)(F) of the Act
Therefore, the Commission finds that acceptance of the additional EM Contract, on the terms and conditions set out in ICC's Rules, is consistent with the prompt and accurate clearance and settlement of securities transactions and derivative agreements, contracts, and transactions cleared by ICC, the safeguarding of securities and funds in the custody or control of ICC, and the protection of investors and the public interest, within the meaning of Section 17A(b)(3)(F) of the Act.
On the basis of the foregoing, the Commission finds that the proposed rule change is consistent with the requirements of the Act and in particular with the requirements of Section 17A 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 (“Act”)
FINRA is proposing to amend FINRA Rule 2360 (Options) to increase the position limit for conventional options on the following exchange-traded funds (“ETF”): The Standard and Poor's Depositary Receipts Trust (“SPY”), iShares Russell 2000 ETF (“IWM”), PowerShares QQQ Trust (“QQQ”), iShares MSCI Emerging Markets ETF (“EEM”), iShares China Large-Cap ETF (“FXI”), iShares MSCI EAFE ETF (“EFA”), iShares MSCI Brazil Capped ETF (“EWZ”), iShares 20+ Year Treasury Bond Fund ETF (“TLT”), and iShares MSCI Japan ETF (“EWJ”).
Below is the text of the proposed rule change. Proposed new language is in italics; proposed deletions are in brackets.
(a) No Change.
(1) through (2) No Change.
(A) Stock Options—
(i) through (ii) No Change.
(iii) Conventional Equity Options
a. For purposes of this paragraph (b), standardized equity option contracts of the put class and call class on the same side of the market overlying the same security shall not be aggregated with conventional equity option contracts or FLEX Equity Option contracts overlying the same security on the same side of the market. Conventional equity option contracts of the put class and call class on the same side of the market overlying the same security shall be subject to a position limit of:
1. through 5. No Change.
6. for selected conventional options on exchange-traded funds (“ETF”), the position limits are listed in the chart below:
b. No Change.
(B) through (D) No Change.
(4) through (24) No Change.
(c) No Change.
.01 through .03 No Change.
In its filing with the Commission, FINRA 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. FINRA has prepared summaries, set forth in sections A, B, and C below, of the most significant aspects of such statements.
FINRA Rule 2360(b)(3)(A) imposes a position limit on the number of equity options contracts in each class on the same side of the market that can be held or written by a member, a person associated with a member, or a customer or a group of customers acting in concert. Position limits are intended to prevent the establishment of options positions that can be used to manipulate or disrupt the underlying market or might create incentives to manipulate or disrupt the underlying market so as to benefit the options position. In addition, position limits serve to reduce the potential for disruption of the options market itself, especially in illiquid options classes.
Rule 2360(b)(3)(A)(i) does not independently establish a position limit for standardized equity options. Rather, the position limit established by the rules of an options exchange for a particular equity option is the applicable position limit for purposes of Rule 2360.
The proposed rule change would amend the table provided in Rule 2360(b)(3)(A)(iii)a.6. as follows:
• The position limits for options on SPY would be increased from 900,000 contracts to 1,800,000 contracts;
• The position limit for options on IWM would be increased from 500,000 contracts to 1,000,000 contracts;
• The position limit for options on QQQ would be increased from 900,000 contracts to 1,800,000 contracts; and
• The position limit for options on EEM would be increased from 500,000 contracts to 1,000,000 contracts.
In addition, the proposed rule change would add to the table provided in Rule 2360(b)(3)(A)(iii)a.6. as follows, with the effect of each ETF being increased from the current position limit of 250,000 contracts:
• The position limit for options on FXI would be increased to 500,000 contracts;
• The position limit for options on EFA would be increased to 500,000 contracts;
• The position limit for options on EWZ would be increased to 500,000 contracts;
• The position limit for options on TLT would be increased to 500,000 contracts; and
• The position limit for options on EWJ would be increased to 500,000 contracts.
In support of the proposed rule change, as noted by Cboe, position limits are determined by the option exchange's requirements according to the number of outstanding shares and the trading volume of the underlying ETF over the past six months.
FXI tracks the performance of the FTSE China 50 Index, which is composed of the 50 largest Chinese stocks.
In support of this proposal, all trading and other statistics, except SPY which were compiled by FINRA, have been compiled by Cboe as of the dates provided by Cboe and provided in its proposed rule change to increase the applicable positions limits:
FINRA agrees as proposed by Cboe that the liquidity in the underlying ETFs, and the liquidity in the ETF options support its request to increase the position limits for the options subject to the proposed rule change. As to the underlying ETF shares, the average daily trading volume across all exchanges for the period of January 1 to July 31, 2017 was: (i) FXI-15.08 million shares; (ii) EEM-52.12 million shares; (iii) IWM-27.46 million shares; (iv) EFA-19.42 million shares; (v) EWZ-17.08 million shares; (vi) TLT-8.53 million shares; (vii) QQQ- 26.25 million shares; (vii) EWJ-6.06 million shares; and (viii) SPY-64.63 million shares.
In proposing the increased position limits, FINRA considered the availability of economically equivalent products and their respective position limits. For instance, some of the ETFs underlying options subject to this proposal are based on broad-based indices that underlie cash-settled options that are economically equivalent to the ETF options that are the subject of this proposal and have no position limits (NDX and SPX). Other ETFs are based on broad-based indexes that underlie cash-settled options with position limits reflecting notional values that are larger than the current position limits for ETF analogues (EEM and EFA). Where there was no approved index analogue, FINRA believes, based on the liquidity, breadth and depth of the underlying market, that the index referenced by the ETF would be considered a broad-based index (example FXI and EWJ).
For example, the PowerShares QQQ Trust or QQQ is an ETF that tracks the Nasdaq 100 Index or NDX, which is an index composed of 100 of the largest non-financial securities listed on the Nasdaq Stock Market LLC (“Nasdaq”). Options on NDX are currently subject to no position limits but share similar trading characteristics as QQQ. Based on QQQ's share price of $154.5422 and NDX's index level of 6,339.14, approximately 40 contracts of QQQ equals one contract of NDX. Assume that options on NDX are subject to the standard position limit of 25,000 contracts for broad-based index options under options exchange rules. Based on the above comparison of notional values, this would result in a position limit equivalent to 1,000,000 contracts for QQQ as NDX's analogue. However, options on NDX are not subject to position limits and has an average daily trading volume of 15,300 contracts. Options on QQQ are currently subject to a position limit of 900,000 contracts but has a much higher average daily trading volume of 579,404 contracts. Furthermore, NDX currently has a market capitalization of $17.2 trillion and QQQ has a market capitalization of
The SPDR® S&P 500® ETF Trust or SPY seeks to provide investment results that, before expenses, correspond generally to the price and yield performance of the S&P 500® Index or SPX, which is an index composed of 500 large-cap U.S. companies. Options on the SPX have no position limits and share similar trading characteristics as SPY. Based on SPY's price of $263.15 and SPX's index level of 2640.87, approximately 10 contracts of SPY equals one contract of SPX.
The iShares Russell 2000 ETF or IWM, is an ETF that also tracks the Russell 2000 index or RUT, which is an index composed of 2,000 small-cap domestic companies in the Russell 2000 index. Options on RUT are currently subject to no position limits but share similar trading characteristics as IWM. Based on IWM's share price of $144.77 and RUT's index level of 1,486.88, approximately 10 contracts of IWM equals one contract of RUT. Assume that options on RUT are subject to the standard position limit of 25,000 contracts for broad-based index options under options exchange rules. Based on the above comparison of notional values, this would result in a position limit equivalent to 250,000 contracts for options on IWM as RUT's analogue. However, options on RUT are not subject to position limits and has an average daily trading volume of 66,200 contracts. Options on IWM are currently subject to a position limit of 500,000 contracts but has a much higher average daily trading volume of 490,070 contracts. The Commission has approved no position limit for options on RUT, although it has a much lower average daily trading volume than its analogue, the IWM. Furthermore, RUT currently has a market capitalization of $2.4 trillion and IWM has a market capitalization of $35,809.1 million, and the component securities of RUT, in aggregate, have traded an average of 270 million shares per day in 2017, both large enough to absorb any price movement caused by a large trade in the IWM. Therefore, FINRA believes it is reasonable to increase the position limit for options on IWM from 500,000 to 1,000,000 contracts.
EEM tracks the performance of the MSCI Emerging Markets Index or MXEF, which is composed of approximately 800 component securities from emerging market countries from all over the world. Below makes the same notional value comparisons as made above. Based on EEM's share price of $47.06 and MXEF's index level of 1,136.45, approximately 24 contracts of EEM equals one contract of MXEF. Assume that options on MXEF are subject to the standard position limit of 25,000 contracts for broad-based index options under options exchange rules. Based on the above comparison of notional values, this would result in a position limit economically equivalent to 604,000 contracts for options on EEM as MXEF's analogue. However, MXEF has an average daily trading volume of 180 contracts. Options on EEM is currently subject to a position limit of 500,000 contracts but has a much higher average daily trading volume of 287,357 contracts. Furthermore, MXEF currently has a market capitalization of $5.18 trillion and EEM has a market capitalization of $34,926.1 million, and the component securities of MXEF, in aggregate, have traded an average of 33.6 billion shares per day in 2017, both large enough to absorb any price movement caused by a large trade in the EEM. Therefore, based on the comparison of average daily trading volume, FINRA believes it is reasonable to increase the position limit for options on EEM from 500,000 to 1,000,000 contracts.
EFA tracks the performance of the MSCI EAFE Index or MXEA, which has over 900 component securities designed to represent the performance of large and mid-cap securities across 21 developed markets, including countries in Europe, Australia and the Far East, excluding the U.S. and Canada. Below makes the same notional value comparison as made above. Based on EFA's share price of $69.16 and MXEA's index level of 1,986.15, approximately 29 contracts of EFA equals one contract of MXEA. Assume options on MXEA are subject to the standard position limit of 25,000 contracts for broad-based index options under options exchange rules. Based on the above comparison of notional values, this would result in a position limit economically equivalent to 721,000 contracts for EFA as MXEA's analogue. Furthermore, MXEA currently has a market capitalization of $18.7 trillion and EFA has a market capitalization of $78,870.3 million, and the component securities of MXEA, in aggregate, have traded an average of 4.6 billion shares per day in 2017, both large enough to absorb any price movement caused by a large trade in EFA. However, MXEA has an average daily trading volume of 270 contracts. Options on EFA is currently subject to a position limit of 250,000 contracts but has a much higher average daily trading volume of 98,844 contracts. Based on the above comparisons, FINRA believes it is reasonable to increase the position limit for options on EFA from 250,000 to 500,000 contracts.
FXI tracks the performance of the FTSE China 50 Index, which is composed of the 50 largest Chinese stocks. There is currently no index analogue for FXI approved for options trading. Options on FXI are currently subject to a position limit of 250,000 contracts but has a much higher average daily trading volume of 15.08 million shares. However, the FTSE China 50 Index currently has a market capitalization of $1.7 trillion and FXI has a market capitalization of $2,623.18 million, both large enough to absorb any price movement caused by a large trade
EWZ tracks the performance of the MSCI Brazil 25/50 Index, which is composed of shares of large and mid-size companies in Brazil. There is currently no index analogue for EWZ approved for options trading. Options on EWZ are currently subject to a position limit of 250,000 contracts but the ETF has a much higher average daily trading volume of 17.08 million shares. However, the MSCI Brazil 25/50 Index currently has a market capitalization of $700 billion and EWZ has a market capitalization of $6,023.4 million, both large enough to absorb any price movement caused by a large trade in EWZ. The components of the MSCI Brazil 25/50 Index, in aggregate, have an average daily trading volume of 285 million shares. Based on the above comparisons, FINRA believes it is reasonable to increase the position limit for options on EWZ from 250,000 to 500,000 contracts.
TLT tracks the performance of the ICE U.S. Treasury 20+ Year Bond Index, which is composed of long-term U.S. Treasury bonds. There is currently no index analogue for TLT approved for options trading. However, the U.S. Treasury market is one of the largest and most liquid markets in the world, with over $14 trillion outstanding and turnover of approximately $500 billion per day. TLT currently has a market capitalization of $7,442.4 million, both large enough to absorb any price movement caused by a large trade in TLT. Therefore, any potential for manipulation will not increase solely due to the increase in position limits as set forth in this proposal. Based on the above comparisons, FINRA believes it is reasonable to increase the position limit for options on TLT from 250,000 to 500,000 contracts.
EWJ tracks the MSCI Japan Index, which tracks the performance of large and mid-sized companies in Japan. There is currently no index analogue for EWJ approved for options trading. However, the MSCI Japan Index has a market capitalization of $3.5 trillion and EWJ has a market capitalization of $16,625.1 million, and the component securities of the MSCI Japan Index, in aggregate, have traded an average of 1.1 billion shares per day in 2017, both large enough to absorb any price movement caused by a large trade in EWJ. Options on EWJ is currently subject to a position limit of 250,000 contracts and has an average daily trading volume of 6.6 million shares. Based on the above comparisons, FINRA believes it is reasonable to increase the position limit for options on EWJ from 250,000 to 500,000 contracts.
FINRA believes that increasing the position limits for the conventional options subject to the proposed rule change would lead to a more liquid and competitive market environment for these options, which will benefit customers interested in these products.
Further, FINRA believes that the increased position limits provisions are appropriate in light of the existing surveillance procedures and reporting requirements at FINRA,
In addition, large stock holdings must be disclosed to the Commission by way of Schedules 13D or 13G.
Finally, FINRA believes that the current financial requirements imposed by FINRA and by the Commission adequately address financial responsibility concerns that a member or its customer will maintain an inordinately large unhedged position in any option with a higher position limit. Current margin and risk-based haircut methodologies serve to limit the size of positions maintained by any one account by increasing the margin or capital that a member must maintain for a large position. Under Rule 4210(f)(8)(A), FINRA also may impose a higher margin requirement upon a member when FINRA determines a higher requirement is warranted. In addition, the Commission's net capital rule
FINRA has filed the proposed rule change for immediate effectiveness and has requested that the SEC waive the requirement that the proposed rule change not become operative for 30 days after the date of the filing, so FINRA can implement the proposed rule change immediately.
FINRA believes that the proposed rule change is consistent with the provisions of Section 15A(b)(6) of the Act,
Increased position limits for select actively traded options, such as those proposed herein, is not novel and has been previously approved by the Commission. For example, the Commission has previously approved a position limit of 1,800,000 contracts on options on SPY.
Furthermore, the proposed position limits would continue to address potential manipulative activity while allowing for potential hedging activity for appropriate economic purposes. The creation and redemption process for these ETFs also lessens the potential for manipulative activity. When an ETF company wants to create more ETF shares, it looks to an Authorized Participant, which is a market maker or other large financial institution, to acquire the securities the ETF is to hold. For instance, IWM is designed to track the performance of the Russell 2000 Index. The Authorized Participant will purchase all the Russell 2000 constituent securities in the exact same weight as the index, then deliver those shares to the ETF provider. In exchange, the ETF provider gives the Authorized Participant a block of equally valued ETF shares, on a one-for-one fair value basis. The price is based on the net asset value, not the market value at which the ETF is trading. The creation of new ETF units can be conducted all trading day and is not subject to position limits. This process can also work in reverse where the ETF company seeks to decrease the number of shares that are available to trade. The creation and redemption process, therefore, creates a direct link to the underlying components of the ETF, and serves to mitigate potential price impact of the ETF shares that might otherwise result from increased position limits.
The ETF creation and redemption process keeps ETF share prices trading in line with the ETF's underlying net asset value. Because an ETF trades like a stock, its price will fluctuate during the trading day, due to simple supply and demand. If demand to buy an ETF is high, for instance, the ETF's share price might rise above the value of its underlying securities. When this happens, an Authorized Participant can arbitrage this difference by buying the underlying shares that compose the ETF and then selling the ETF shares on the open market. This drives the ETF's share price back toward fair value. Likewise, if the ETF starts trading at a discount to the securities it holds, the Authorized Participant can buy shares of the ETF and redeem them for the underlying securities. Buying undervalued ETF shares drives the price of the ETF back toward fair value. This arbitrage process helps to keep an ETF's price in line with the value of its underlying portfolio.
Lastly, the Commission expressed the belief that removing position and exercise limits may bring additional depth and liquidity without increasing concerns regarding intermarket manipulation or disruption of the options or the underlying securities.
FINRA 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.
FINRA has undertaken an economic impact assessment, as set forth below, to analyze the potential economic impacts, including anticipated costs, benefits, and distributional and competitive effects transfers of wealth, relative to the current baseline, and the alternatives FINRA considered in assessing how to best meet its regulatory objectives.
FINRA is proposing to amend Rule 2360 to harmonize FINRA's position limits for conventional options with the position limit for standardized options.
Per FINRA Rule 2360(b)(30)(A)(iii) conventional equity options are subject to a basic position limit of 25,000 contracts or higher for conventional option contracts on securities that underlie exchange-traded options qualifying for a higher tier as determined by option exchange rules. The existing position limits for conventional options on ETFs are: 900,000 contracts for SPY or QQQ, 500,000 contracts for IWM or EEM, and 250,000 contracts for FXI, EFA, EWZ, TLT, or EWJ. Option exchanges have recently increased (or in the case of SPY decreased from the pilot program) position limit options on several ETFs such as SPY, IWM, QQQ, EEM, FXI, EFA, EWZ, TLT, and EWJ.
As noted above, the proposed rule change would amend Rule 2360 to harmonize FINRA's position limits for conventional options with the position limit for standardized options.
In addition, if the existing position limits serve as a constraint, then an
The extent of the constraint imposed by the current limit on conventional options is related to the ability of an investor to achieve similar economic exposure through other means. If there are other securities, such as an option on a closely related index, that exist and provide similar economic exposure less expensively, then the value of lessening the position limit on conventional options on ETFs is lower. Members may rely on information and data feeds from the Options Clearing Corporation to assist in their monitoring position limits. Because position limits on the standardized and conventional side have traditionally been consistent, members have relied on this feed for both standardized and conventional options. If the position limits between standardized and conventional options are conformed, then the cost from monitoring position limits should decline for member firms.
The proposed rule change may impose limited operational cost on member firms that trade conventional options on ETFs, as these same firms would need to revise position limits that are used in trading systems. However, the proposed rule change should not impose additional costs, because it is difficult to disrupt or manipulate the underlying market, create an incentive to disrupt or manipulate the underlying market for the purpose of profiting from the options position, or disrupt or manipulate the options market for conventional options on ETFs affected by this proposed rule. ETFs that underlie options subject to the proposed rule change are highly liquid, and are based on a broad set of highly liquid securities, which makes the market difficult to manipulate or disrupt. In fact, options on certain broad-based security indexes have no position limits. Furthermore, the creation and redemption process for these ETFs reduces the potential for disruptive or manipulative activity. New ETF units may be created at any time during the trading day and are not subject to position limits. Consequently, there is a direct link between the underlying components of the ETF and the ETF, which keeps ETF share prices trading in line with the ETF's underlying net asset value.
No further alternatives are under consideration.
Written comments were neither solicited nor received.
Because the foregoing proposed rule change does not: (i) Significantly affect the protection of investors or the public interest; (ii) impose any significant burden on competition; and (iii) become operative for 30 days after the date of the filing, or such shorter time as the Commission may designate if consistent with the protection of investors and the public interest, it has become effective pursuant to Section 19(b)(3)(A) of the Act
FINRA has asked the Commission to waive the 30-day operative delay so that FINRA may immediately harmonize position limits with those of other self-regulatory organizations to ensure consistent regulation. For this reason, the Commission believes that waiving the 30-day operative delay is consistent with the protection of investors and the public interest. Therefore, the Commission hereby waives the operative delay and designates the proposal operative upon filing.
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 necessary or appropriate in the public interest, for the protection of investors, or 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 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.
U.S. Small Business Administration.
Notice.
This is a Notice of the Presidential declaration of a major disaster for Public Assistance Only for the State of ALASKA (FEMA—4391—DR), dated 09/05/2018.
Issued on 09/05/2018.
Submit completed loan applications to: U.S. Small Business Administration, Processing and Disbursement Center, 14925 Kingsport Road, Fort Worth, TX 76155.
A. Escobar, Office of Disaster Assistance, U.S. Small Business Administration, 409 3rd Street SW, Suite 6050, Washington, DC 20416, (202) 205-6734.
Notice is hereby given that as a result of the President's major disaster declaration on 09/05/2018, Private Non-Profit organizations that provide essential services of a governmental nature may file disaster loan applications at the address listed above or other locally announced locations.
The following areas have been determined to be adversely affected by the disaster:
The Interest Rates are:
The number assigned to this disaster for physical damage is 156906 and for economic injury is 156910.
U.S. Small Business Administration.
Notice of open Federal Advisory committee meeting.
The SBA is issuing this notice to announce the location, date, time and agenda for the next meeting of the Audit and Financial Management Advisory Committee (AFMAC). The meeting will be open to the public.
The meeting will be held on Wednesday, October 31, 2018, starting at 2:00 p.m. until approximately 4:00 p.m. Eastern time.
The meeting will be held at the U.S. Small Business Administration, 409 3rd Street SW, Office of Performance Management and Chief Financial Officer Conference Room, 6th Floor, Washington, DC 20416.
The meeting is open to the public; however advance notice of attendance is requested. Anyone wishing to attend and/or make a presentation to the AFMAC must contact Tim Gribben by fax or email, in order to be placed on the agenda. Tim Gribben, Chief Financial Officer, 409 3rd Street SW, 6th Floor, Washington, DC 20416, phone (202) 205-6449; fax: (202) 481-0546; email:
Additionally, if you need accommodations because of a disability or require additional information, please contact Donna Wood at (202) 619-1608; email
Pursuant to section 10(a)(2) of the Federal Advisory Committee Act (5 U.S.C., Appendix 2), SBA announces the meeting of the AFMAC. The AFMAC is tasked with providing recommendation and advice regarding the Agency's financial management, including the financial reporting process, systems of internal controls, and audit process and process for monitoring compliance with relevant law and regulations.
The purpose of the meeting is to discuss the SBA's Financial Reporting, Audit Findings Remediation, Ongoing OIG Audits including the Information Technology Audit, FMFIA Assurance/A-123 Internal Control Program, Credit Modeling, Performance Management, Acquisition Division Update, Improper Payments and current initiatives.
U.S. Small Business Administration.
Notice.
This is a Notice of the Presidential declaration of a major disaster for Public Assistance Only for the State of Minnesota (FEMA-4390-DR), dated 09/05/2018.
Issued on 09/05/2018.
Submit completed loan applications to: U.S. Small Business Administration, Processing and Disbursement Center, 14925 Kingsport Road, Fort Worth, TX 76155.
A. Escobar, Office of Disaster Assistance, U.S. Small Business Administration, 409 3rd Street SW, Suite 6050, Washington, DC 20416, (202) 205-6734.
Notice is hereby given that as a result of the President's major disaster declaration on 09/05/2018, Private Non-Profit organizations that provide essential
The following areas have been determined to be adversely affected by the disaster:
The Interest Rates are:
The number assigned to this disaster for physical damage is 156886 and for economic injury is 156890.
U.S. Small Business Administration.
Notice of open Federal Advisory committee meeting
The SBA is issuing this notice to announce the location, date, time and agenda for the next meeting of the Audit and Financial Management Advisory Committee (AFMAC). The meeting will be open to the public.
The meeting will be held on Friday, October 5, 2018, starting at 1:00 p.m. until approximately 3:00 p.m. Eastern Time.
The meeting will be held at the U.S. Small Business Administration, 409 3rd Street SW, Office of Performance Management and Chief Financial Officer Conference Room, 6th Floor, Washington, DC 20416.
The meeting is open to the public; however advance notice of attendance is requested. Anyone wishing to attend and/or make a presentation to the AFMAC must contact Tim Gribben by fax or email, in order to be placed on the agenda. Tim Gribben, Chief Financial Officer, 409 3rd Street SW, 6th Floor, Washington, DC 20416, phone (202) 205-6449; fax: (202) 481-0546; email:
Additionally, if you need accommodations because of a disability or require additional information, please contact Donna Wood at (202) 619-1608, email:
Pursuant to section 10(a)(2) of the Federal Advisory Committee Act (5 U.S.C., Appendix 2), SBA announces the meeting of the AFMAC. The AFMAC is tasked with providing recommendation and advice regarding the Agency's financial management, including the financial reporting process, systems of internal controls, audit process and process for monitoring compliance with relevant law and regulations.
The purpose of the meeting is to discuss the SBA's Financial Reporting, Audit Findings Remediation, Ongoing OIG Audits including the Information Technology Audit, FMFIA Assurance/A-123 Internal Control Program, Credit Modeling, Performance Management, Acquisition Division Update, Improper Payments and current initiatives.
Federal Highway Administration (FHWA), U.S Department of Transportation (DOT).
Notice.
The FHWA is establishing a new Special Experimental Project (SEP-16) to test and evaluate the delegation of program-level responsibilities of the Federal-aid highway program (FAHP) to States, including the appropriate steps States should take to request to exercise delegated authority. The FHWA anticipates there is interest in State assumption of program-level actions for approval of design standards, noise policies, preventative maintenance programs, and real property acquisitions and disposals. The term “program-level actions” in this context means decisions that apply generally to projects in a State and broadly affect the implementation of the Federal-aid highway program in the State, but excludes Federal decisions relating to eligibility, obligation, reimbursement, authorization, and compliance.
This new SEP-16 project is being initiated on September 20, 2018.
For technical information: Cindi Ptak, Office of Innovative Program Delivery (HIN), (202) 366-8408; for legal information: Janet Myers, Office of the Chief Counsel (HCC), (202) 366-2019, 1200 New Jersey Avenue SE, Washington, DC 20590. Office hours are from 8:00 a.m. to 4:30 p.m., ET, Monday through Friday, except Federal holidays.
An electronic copy of this notice may be downloaded from the
The Fixing America's Surface Transportation (FAST) Act (Pub. L. 114-94) builds on the authorities and requirements in earlier legislation to promote the transition from FHWA project-level “full-oversight” of the FAHP to a risk-based approach to FHWA oversight activities. The FHWA's use of a risk-based approach to stewardship and oversight is intended to optimize the successful delivery of projects and to ensure compliance with Federal requirements by focusing FHWA resources most efficiently and effectively.
Unless authorized by law, FHWA may not delegate or assign its decision-making responsibilities to a State department of transportation (State DOT). Section 106(c) of Title 23, United States Code (U.S.C.), authorizes States to assume project responsibilities for design, plans, specifications, estimates, contract awards, and inspections for
Section 1316(a) of the FAST Act directs the Secretary of Transportation to use the authority under 23 U.S.C. 106(c) to the maximum extent practicable to allow a State to assume the responsibilities described in 23 U.S.C. 106(c) on both a project-specific and a programmatic basis. Section 1316 of the FAST Act seeks to expand the use of the 23 U.S.C. 106(c) authority for State assumption of responsibilities. State assumption of certain responsibilities is part of the transition to risk-based oversight of the FAHP. To implement section 1316 of the FAST Act, FHWA published a
The FHWA is initiating a new SEP-16 pursuant to authority granted to the Secretary in 23 U.S.C. 502(b) to evaluate potential effects of State assumption of program-level FAHP responsibilities that are not currently assumable. The experimental authority may be used to test deviations from Title 23 statutory, regulatory, or policy provisions, provided that the experimental features are consistent with the overall purpose and intent of the underlying statute, regulation, or policy being tested. Actions explicitly prohibited by statute cannot be the subject of a SEP-16 experiment. The experiment must be consistent with other Federal laws that apply to Title 23 funded activities. For example, the recording statute, 31 U.S.C. 1501, and the Antideficiency Act (31 U.S.C. 1341(a)(1)(A)), vest the responsibility to record obligations of the Federal Government with the Federal agency responsible for administering the Federal assistance program. The FHWA is establishing this SEP-16 to consider program-level authorities (as opposed to project-level actions) States may want to assume. The term “program-level authority” in this context means decisions that apply generally to projects in a State and broadly affect the Federal-aid system in the State, but excludes Federal decisions relating to eligibility, obligation, reimbursement, authorization, and compliance.
This SEP-16 is intended to allow States to propose the assumption of Title 23 program-level responsibilities provided they can demonstrate they have, or can reasonably put in place, the necessary laws, regulations, controls, and resources to take on the Federal role. Because States already have experience with project-level assumptions under 23 U.S.C. 106(c), FHWA anticipates initially receiving proposals for program-level authority affecting these types of areas.
This SEP-16 will allow FHWA to understand the implications of delegation of program-wide decisions in various program areas. The lessons learned from SEP-16 will aid FHWA in developing comprehensive policies and inform stakeholders if the delegation of specific program-level authorities, or other discretionary authorities established in Title 23, is appropriate.
To facilitate public access to SEP-16 information, all SEP-16 proposals, workplans, and reports will be posted on a public facing website.
This notice announces SEP-16 and requests Letters of Interest. Entities eligible to submit letters (“Applicants”) are State DOTs as defined in 23 U.S.C. 101. Letters of Interest, which should be submitted to the appropriate FHWA Division Office, initiate the application process described below. The Letter of Interest should include a high-level description of the Applicant's proposal, reasons for wanting to assume the program-level authority, and the anticipated resulting improvements to program delivery. Ideally, the Applicant will quantify the resulting improvements in terms of project time and/or cost savings. The Applicant should include enough detail to allow FHWA to determine how the proposal deviates from current law (including regulations) and practice, and how the actions covered by the proposal are addressed in current policy. The Letter of Interest should reference the Title 23 program and the specific legal authority(ies) being requested for delegation. Further, the Applicant should provide specific examples that demonstrate experience with project-level delegation in the affected program area(s), if applicable, as well as the level of collaboration conducted so far with relevant FHWA Division or Program Offices about the proposal.
The application process is three-tiered with each step developing more specifics of the proposed program-level assumption(s) for FHWA consideration and feedback. The FHWA will evaluate each step to determine whether a proposal falls within the scope of section 502(b) and is appropriate for this experimental process before inviting and working with an Applicant to proceed to the next step for more detailed proposal development.
The first step in the application process is the Letter of Interest described above. The FHWA will acknowledge receipt of the Letter of Interest and provide an anticipated timeframe for initially evaluating the proposal and providing a formal response. After review of the proposal, FHWA will provide a formal response that will either request the Applicant to proceed with submitting a Concept Paper, or provide FHWA's explanation for not advancing the proposal.
If a Concept Paper is requested, the Applicant should submit to the appropriate FHWA Division Office a narrative further detailing the Applicant's proposal. This Concept Paper should not exceed 5 pages and be formatted single-spaced, using a standard 12-point font with 1-inch margins. Charts, tables, and other items may also be submitted as attachments to supplement the narrative and do not count toward the five-page limit. The Concept Paper should demonstrate that the State has the necessary laws, regulations, controls, and resources in place to assume the Federal role for the program-level responsibilities requested. If applicable, the Applicant may use experience with assumption of project-level authorities to demonstrate readiness to assume program-level responsibilities. If any necessary piece is missing, the Applicant should outline a plan and timeline anticipated to put pieces in place. In addition, the Concept Paper should detail supporting analysis for the anticipated program delivery improvements and consider a risk assessment of the expected impact the assumption of authority may have on the State's program—specifically on resources, processes, and stakeholders—and include measures the State would use to ensure the responsibilities are carried out in accordance with Federal requirements. The Concept Paper
Since the requirements for the Detailed Proposal will vary depending on the complexity of the proposed program assumption and the results of FHWA's evaluation of the Concept Paper, the appropriate FHWA Division will coordinate with the Applicant in preparing the Detailed Proposal. At a minimum, the Applicant's Detailed Proposal should: (1) Propose a duration for conducting the experiment, including a timeline for any transition activities; (2) identify key personnel and contacts with proposed roles and responsibilities; and (3) recommend an Evaluation Plan with reporting mechanisms, performance measures, goals, and other evaluation criteria, and frequency of reviews. To provide consistency among the SEP-16 experiments, FHWA will provide the Applicant certain performance measures and evaluation criteria common to all SEP-16 Evaluation Plans.
Should FHWA decide to proceed with the experiment, FHWA and the Applicant will enter into a memorandum of understanding and develop a workplan for the experiment.
The FHWA is committed to continuing its transition to a risk-based approach to stewardship and oversight of the FAHP. To this end, SEP-16 is designed to provide FHWA with a better understanding of the implications of allowing States to assume program-level authorities in various program areas. This notice announces the SEP-16 and identifies the process for States to apply to assume program-level responsibilities for the FAHP in their States.
Maritime Administration, DOT.
Notice.
The Secretary of Transportation, as represented by the Maritime Administration (MARAD), is authorized to grant waivers of the U.S.-build requirements of the coastwise trade laws to allow the carriage of no more than twelve passengers for hire on vessels, which are three years old or more. A request for such a waiver has been received by MARAD. The vessel, and a brief description of the proposed service, is listed below.
Submit comments on or before October 22, 2018.
You may submit comments identified by DOT Docket Number MARAD-2018-0148 by any one of the following methods:
•
•
• 1200 New Jersey Avenue SE, West Building, Room W12-140, Washington, DC 20590, between 9 a.m. and 5 p.m., Monday through Friday, except on Federal holidays.
If you mail or hand-deliver your comments, we recommend that you include your name and a mailing address, an email address, or a telephone number in the body of your document so that we can contact you if we have questions regarding your submission.
Bianca Carr, U.S. Department of Transportation, Maritime Administration, 1200 New Jersey Avenue SE, Room W23-453, Washington, DC 20590. Telephone 202-366-9309, Email
As described by the applicant the intended service of the vessel REBEL SOUL is:
The complete application is available for review identified in the DOT docket as MARAD-2018-0148 at
Please submit your comments, including the attachments, following the instructions provided under the above heading entitled
Go to the docket online at
Yes. Be aware that your entire comment, including your personal identifying information, will be made publicly available.
If you wish to submit comments under a claim of confidentiality, you should submit three copies of your complete submission, including the information you claim to be confidential business information, to the Department of Transportation, Maritime Administration, Office of Legislation and Regulations, MAR-225, W24-220, 1200 New Jersey Avenue SE, Washington, DC 20590. Include a cover letter setting forth with specificity the basis for any such claim and, if possible, a summary of your submission that can be made available to the public.
In accordance with 5 U.S.C. 553(c), DOT solicits comments from the public to better inform its rulemaking process. DOT posts these comments, without edit, to
* * *
By Order of the Maritime Administrator.
Maritime Administration, DOT.
Notice.
The Secretary of Transportation, as represented by the Maritime Administration (MARAD), is authorized to grant waivers of the U.S.-build requirements of the coastwise trade laws to allow the carriage of no more than twelve passengers for hire on vessels, which are three years old or more. A request for such a waiver has been received by MARAD. The vessel, and a brief description of the proposed service, is listed below.
Submit comments on or before October 22, 2018.
You may submit comments identified by DOT Docket Number MARAD-2018-0147 by any one of the following methods:
•
•
If you mail or hand-deliver your comments, we recommend that you include your name and a mailing address, an email address, or a telephone number in the body of your document so that we can contact you if we have questions regarding your submission.
Bianca Carr, U.S. Department of Transportation, Maritime Administration, 1200 New Jersey Avenue SE, Room W23-453, Washington, DC 20590. Telephone 202-366-9309, Email
As described by the applicant the intended service of the vessel ONE IRON is:
The complete application is available for review identified in the DOT docket as MARAD-2018-0147 at
Please submit your comments, including the attachments, following the instructions provided under the above heading entitled
Go to the docket online at
Yes. Be aware that your entire comment, including your personal identifying information, will be made publicly available.
If you wish to submit comments under a claim of confidentiality, you should submit three copies of your complete submission, including the information you claim to be confidential business information, to the Department of Transportation, Maritime Administration, Office of Legislation and Regulations, MAR-225, W24-220, 1200 New Jersey Avenue SE, Washington, DC 20590. Include a cover letter setting forth with specificity the basis for any such claim and, if possible, a summary of your submission that can be made available to the public.
In accordance with 5 U.S.C. 553(c), DOT solicits comments from the public to better inform its rulemaking process. DOT posts these comments, without edit, to
* * *
By Order of the Maritime Administrator.
Maritime Administration, DOT.
Notice.
The Secretary of Transportation, as represented by the Maritime Administration (MARAD), is authorized to grant waivers of the U.S.-build requirements of the coastwise trade laws to allow the carriage of no more than twelve passengers for hire on vessels, which are three years old or more. A request for such a waiver has been received by MARAD. The vessel, and a brief description of the proposed service, is listed below.
Submit comments on or before October 22, 2018.
You may submit comments identified by DOT Docket Number MARAD-2018-0149 by any one of the following methods:
•
•
If you mail or hand-deliver your comments, we recommend that you include your name and a mailing address, an email address, or a telephone number in the body of your document so that we can contact you if we have questions regarding your submission.
Bianca Carr, U.S. Department of Transportation, Maritime Administration, 1200 New Jersey Avenue SE, Room W23-453, Washington, DC 20590. Telephone 202-366-9309, Email
As described by the applicant the intended service of the vessel RICHARD H. DANA is:
The complete application is available for review identified in the DOT docket as MARAD-2018-0149 at
Please submit your comments, including the attachments, following the instructions provided under the above heading entitled
Go to the docket online at
Yes. Be aware that your entire comment, including your personal identifying information, will be made publicly available.
If you wish to submit comments under a claim of confidentiality, you should submit three copies of your complete submission, including the information you claim to be confidential business information, to the Department of Transportation, Maritime Administration, Office of Legislation and Regulations, MAR-225, W24-220, 1200 New Jersey Avenue SE, Washington, DC 20590. Include a cover letter setting forth with specificity the basis for any such claim and, if possible, a summary of your submission that can be made available to the public.
In accordance with 5 U.S.C. 553(c), DOT solicits comments from the public to better inform its rulemaking process. DOT posts these comments, without edit, to
* * *
By Order of the Maritime Administrator.
Maritime Administration, DOT.
Notice.
The Secretary of Transportation, as represented by the Maritime Administration (MARAD), is authorized to grant waivers of the U.S.-build requirements of the coastwise trade laws to allow the carriage of no more than twelve passengers for hire on vessels, which are three years old or more. A request for such a waiver has been received by MARAD. The vessel, and a brief description of the proposed service, is listed below.
Submit comments on or before October 22, 2018.
You may submit comments identified by DOT Docket Number MARAD 2018-0146 by any one of the following methods:
•
•
If you mail or hand-deliver your comments, we recommend that you include your name and a mailing address, an email address, or a telephone number in the body of your document so that we can contact you if we have questions regarding your submission.
Bianca Carr, U.S. Department of Transportation, Maritime Administration, 1200 New Jersey Avenue SE, Room W23-453, Washington, DC 20590. Telephone 202-366-9309, Email
As described by the applicant the intended service of the vessel GIOVANNINO is:
The complete application is available for review identified in the DOT docket as MARAD-2018-0146 at
Please submit your comments, including the attachments, following the instructions provided under the above heading entitled
Go to the docket online at
Yes. Be aware that your entire comment, including your personal identifying information, will be made publicly available.
If you wish to submit comments under a claim of confidentiality, you should submit three copies of your complete submission, including the information you claim to be confidential business information, to the Department of Transportation, Maritime Administration, Office of Legislation and Regulations, MAR-225, W24-220, 1200 New Jersey Avenue SE, Washington, DC 20590. Include a cover letter setting forth with specificity the basis for any such claim and, if possible, a summary of your submission that can be made available to the public.
In accordance with 5 U.S.C. 553(c), DOT solicits comments from the public to better inform its rulemaking process. DOT posts these comments, without edit, to
* * *
By Order of the Maritime Administrator.
Maritime Administration, DOT.
Notice.
The Secretary of Transportation, as represented by the Maritime Administration (MARAD), is authorized to grant waivers of the U.S.-build requirements of the coastwise trade laws to allow the carriage of no more than twelve passengers for hire on vessels, which are three years old or more. A request for such a waiver has been received by MARAD. The vessel, and a brief description of the proposed service, is listed below.
Submit comments on or before October 22, 2018.
You may submit comments identified by DOT Docket Number MARAD-2018-0145 by any one of the following methods:
•
•
If you mail or hand-deliver your comments, we recommend that you include your name and a mailing address, an email address, or a telephone number in the body of your document so that we can contact you if we have questions regarding your submission.
Bianca Carr, U.S. Department of Transportation, Maritime Administration, 1200 New Jersey Avenue SE, Room W23-453, Washington, DC 20590. Telephone 202-366-9309, Email
As described by the applicant the intended service of the vessel FIRST WAVE is:
The complete application is available for review identified in the DOT docket as MARAD-2018-0145 at
Please submit your comments, including the attachments, following the instructions provided under the above heading entitled
Go to the docket online at
Yes. Be aware that your entire comment, including your personal identifying information, will be made publicly available.
If you wish to submit comments under a claim of confidentiality, you should submit three copies of your complete submission, including the information you claim to be confidential business information, to the Department of Transportation, Maritime Administration, Office of Legislation and Regulations, MAR-225, W24-220, 1200 New Jersey Avenue SE, Washington, DC 20590. Include a cover letter setting forth with specificity the basis for any such claim and, if possible, a summary of your submission that can be made available to the public.
In accordance with 5 U.S.C. 553(c), DOT solicits comments from the public to better inform its rulemaking process. DOT posts these comments, without edit, to
* * *
By Order of the Maritime Administrator.
Maritime Administration, DOT.
Notice.
The Secretary of Transportation, as represented by the Maritime Administration (MARAD), is authorized to grant waivers of the U.S.-build requirements of the coastwise trade laws to allow the carriage of no more than twelve passengers for hire on vessels, which are three years old or more. A request for such a waiver has been received by MARAD. The vessel, and a brief description of the proposed service, is listed below.
Submit comments on or before October 22, 2018.
You may submit comments identified by DOT Docket Number MARAD-2018-0152 by any one of the following methods:
•
•
If you mail or hand-deliver your comments, we recommend that you include your name and a mailing address, an email address, or a telephone number in the body of your document so that we can contact you if we have questions regarding your submission.
Bianca Carr, U.S. Department of Transportation, Maritime Administration, 1200 New Jersey Avenue SE, Room W23-453, Washington, DC 20590. Telephone 202-366-9309, Email
As described by the applicant the intended service of the vessel OCEAN SPIRIT is:
The complete application is available for review identified in the DOT docket as MARAD-2018-0152 at
Please submit your comments, including the attachments, following the instructions provided under the above heading entitled
Go to the docket online at
Yes. Be aware that your entire comment, including your personal identifying information, will be made publicly available.
If you wish to submit comments under a claim of confidentiality, you should submit three copies of your complete submission, including the information you claim to be confidential business information, to the Department of Transportation, Maritime Administration, Office of Legislation and Regulations, MAR-225, W24-220, 1200 New Jersey Avenue SE, Washington, DC 20590. Include a cover letter setting forth with specificity the basis for any such claim and, if possible, a summary of your submission that can be made available to the public.
In accordance with 5 U.S.C. 553(c), DOT solicits comments from the public to better inform its rulemaking process. DOT posts these comments, without edit, to
* * *
By Order of the Maritime Administrator.
Maritime Administration, DOT.
Notice.
The Secretary of Transportation, as represented by the Maritime Administration (MARAD), is authorized to grant waivers of the U.S.-build requirements of the coastwise trade laws to allow the carriage of no
Submit comments on or before October 22, 2018.
You may submit comments identified by DOT Docket Number MARAD-2018-0151 by any one of the following methods:
•
•
If you mail or hand-deliver your comments, we recommend that you include your name and a mailing address, an email address, or a telephone number in the body of your document so that we can contact you if we have questions regarding your submission.
Bianca Carr, U.S. Department of Transportation, Maritime Administration, 1200 New Jersey Avenue SE, Room W23-453, Washington, DC 20590. Telephone 202-366-9309, Email
As described by the applicant the intended service of the vessel MISS BROOKE is:
The complete application is available for review identified in the DOT docket as MARAD-2018-0151 at
Please submit your comments, including the attachments, following the instructions provided under the above heading entitled
Go to the docket online at
Yes. Be aware that your entire comment, including your personal identifying information, will be made publicly available.
If you wish to submit comments under a claim of confidentiality, you should submit three copies of your complete submission, including the information you claim to be confidential business information, to the Department of Transportation, Maritime Administration, Office of Legislation and Regulations, MAR-225, W24-220, 1200 New Jersey Avenue SE, Washington, DC 20590. Include a cover letter setting forth with specificity the basis for any such claim and, if possible, a summary of your submission that can be made available to the public.
In accordance with 5 U.S.C. 553(c), DOT solicits comments from the public to better inform its rulemaking process. DOT posts these comments, without edit, to
* * *
By Order of the Maritime Administrator.
The Department of Veterans Affairs (VA) gives notice under the Federal Advisory Committee Act that a meeting of the Federal Advisory Committee on Prosthetics and Special-Disabilities Programs will be held on October 17, 2018, in Room 530 and on October 18, 2018, in Room 730 at VA Central Office, 810 Vermont Avenue NW, Washington, DC 20420. The meeting will convene at 8:30 a.m. on both days, and will adjourn at 4:30 p.m. on October 17 and at 12 noon on October 18. This meeting is open to the public.
The purpose of the Committee is to advise the Secretary of VA on VA's prosthetics programs designed to provide state-of-the-art prosthetics and the associated rehabilitation research, development, and evaluation of such technology. The Committee also provides advice to the Secretary to serve Veterans with spinal cord injuries, blindness or visual impairments, loss of extremities or loss of function, deafness or hearing impairment, and other serious incapacities in terms of daily life functions.
On October 17, the Committee will receive briefings on Ethics; Audiology and Speech Pathology Services; Blind Rehabilitation Service; Pain Management; Prosthetic and Sensory Aids Service; and the Comprehensive Addiction and Recovery Act (CARA). On October 18, the Committee members will receive briefings from National Veterans Sports Programs and Special Events; Recreation Therapy Service; and Rehabilitation Technology Update.
No time will be allocated for receiving oral presentations from the public; however, members of the public may direct questions or submit written statements for review by the Committee in advance of the meeting to Judy Schafer, Ph.D., Designated Federal Officer, Veterans Health Administration, Patient Care Services, Rehabilitation and Prosthetic Services (10P4R), VA, 810 Vermont Avenue NW, Washington, DC 20420, or by email at
Centers for Medicare & Medicaid Services (CMS), HHS.
Proposed rule.
This proposed rule would reform Medicare regulations that are identified as unnecessary, obsolete, or excessively burdensome on health care providers and suppliers. This proposed rule would increase the ability of health care professionals to devote resources to improving patient care by eliminating or reducing requirements that impede quality patient care or that divert resources away from furnishing high quality patient care.
To be assured consideration, comments must be received at one of the addresses provided below, no later than 5 p.m. on November 19, 2018.
In commenting, please refer to file code CMS-3346-P. Because of staff and resource limitations, we cannot accept comments by facsimile (FAX) transmission.
Comments, including mass comment submissions, must be submitted in one of the following three ways (please choose only one of the ways listed):
1.
2.
Please allow sufficient time for mailed comments to be received before the close of the comment period.
3.
For information on viewing public comments, see the beginning of the
Alpha-Banu Wilson, (410) 786-8687. We have also included a subject matter expert under the “Provisions of the Proposed Rule” section for each provision set out in the proposed rule.
To assist readers in referencing sections contained in this preamble, we are providing a Table of Contents.
Over the past several years, we have revised the Conditions of Participation (CoPs) and Conditions for Coverage (CfCs) to reduce the regulatory burden on providers and suppliers while preserving health and safety. We identified obsolete and burdensome regulations that could be eliminated or reformed to improve effectiveness or reduce unnecessary reporting requirements and other costs, with a particular focus on freeing up resources that health care providers, health plans, and States could use to improve or enhance patient health and safety. We also examined policies and practices not codified in rules that could be changed or streamlined to achieve better outcomes for patients while reducing burden on providers and suppliers of care, and we identified non-regulatory changes to increase transparency and to become a better business partner. In addition, the Centers for Medicare & Medicaid Services (CMS) and the Department of Health and Human Services (HHS) have reaffirmed their commitment to the vision of creating an environment where agencies incorporate and integrate the ongoing retrospective review of regulations into Department operations to achieve a more streamlined and effective regulatory framework. The objectives were to improve the quality of existing regulations consistent with statutory requirements; streamline procedural solutions for businesses to enter and operate in the marketplace; maximize net benefits (including benefits that are difficult to quantify); and reduce costs and other burdens on businesses to comply with regulations.
In accordance with these goals, we published three final rules that identified unnecessary, obsolete, or excessively burdensome regulations on health care providers, suppliers, and beneficiaries. These rules further increased the ability of health care professionals to devote resources to improving patient care by eliminating or reducing requirements that impede quality patient care or that divert providing high quality patient care:
• “Reform of Hospital and Critical Access Hospital Conditions of Participation”, published May 16, 2012 (77 FR 29034);
• “Regulatory Provisions to Promote Program Efficiency, Transparency, and Burden Reduction”, published May 16, 2012 (77 FR 29002) and;
• “Regulatory Provisions to Promote Program Efficiency, Transparency, and
This proposed rule is a continuation of our efforts to reduce regulatory burden and is in accordance with the January 30, 2017 Executive Order “Reducing Regulation and Controlling Regulatory Costs” (Executive Order 13771). We propose changes to the current requirements, CoPs, and Conditions for Coverage (CfCs) that will simplify and streamline the current regulations and thereby increase provider flexibility and reduce excessively burdensome regulations, while also allowing providers to focus on providing high-quality healthcare to their patients. This proposed rule will also reduce the frequency of certain required activities and, where appropriate, revise timelines for certain requirements for providers and suppliers and remove obsolete, duplicative, or unnecessary requirements. Ultimately, these proposals balance patient safety and quality, while also providing broad regulatory relief for providers and suppliers.
We seek to reduce burdens for health care providers and patients, improve the quality of care, decrease costs, and ensure that patients and their providers and physicians are making the best health care choices possible. Therefore, we are soliciting public comments on additional regulatory reforms for burden reduction in future rulemaking. Specifically, we are seeking public comment on additional proposals or modifications to the proposals set forth in this rule that would further reduce burden on Medicare and Medicaid participating providers and suppliers and create cost savings, while also preserving quality of care and patient health and safety. Consistent with our “Patients Over Paperwork” Initiative, we are particularly interested in any suggestions to improve existing requirements, within our statutory authority, where they make providing quality care difficult or less effective. We also note that such suggestions could include or expand upon comments submitted in response to Requests for Information (RFIs) that were included in the 2017 prospective payment regulations for most provider types. We refer readers to the public comments that were submitted in response to the RFI for the following 2017 payment regulations:
• End-Stage Renal Disease Prospective Payment System and Payment for Renal Dialysis Services Furnished to Individuals with Acute Kidney Injury, and End-Stage Renal Disease Quality Incentive Program found at
• CY 2018 Home Health Prospective Payment System Rate Update; Value-Based Purchasing Model; and Quality Reporting Requirements found at
• FY 2018 Hospice Wage Index and Payment Rate Update and Hospice Quality found at
• FY 2018 Hospital Inpatient Prospective Payment System for Acute Care Hospitals and the Long-Term Care Hospital Prospective Payment System RFI, found at
• CY 2018 Hospital Outpatient PPS Policy Changes and Payment Rates and Ambulatory Surgical Center Payment System Policy Changes and Payment Rates found at
• FY 2018 Inpatient Rehabilitation Facility Prospective Payment System found at
• FY 2018 Inpatient Psychiatric Facilities Prospective Payment System found at
• CY 2018 Revisions to Payment Policies under the Physician Fee Schedule and Other Revisions to Part B found at
• FY 2018 Prospective Payment System and Consolidated Billing for Skilled Nursing Facilities found at
Public comments on the RFIs can be found by searching for the terms “RFI” or “request for information” in the aforementioned 2017 payment regulation dockets on
The most useful comments will be those that include data or evidence to support the position, offer suggestions to amend specific sections of the existing regulations, or offer particular additions.
We propose to reduce regulatory burden on providers and suppliers by modifying, removing, or streamlining current regulations that we now believe are excessively burdensome. The proposals fall under three categories: (1) Proposals that simplify and streamline processes, (2) proposals that reduce the frequency of activities and revise timelines, and (3) proposals that are obsolete, duplicative, or that contain unnecessary requirements, as follows.
We have concluded that a more condensed and flexible process for discharge planning for RNHCIs would reduce burden and simplify the discharge process for patients. Specifically, we propose to revise the requirements at 42 CFR 403.736(a), requiring an evaluation, and § 403.736(b), requiring a discharge plan. Instead of specifying detailed discharge processes, we would simply require RNHCIs to assess the need for a discharge plan for any patient identified as likely to suffer adverse consequences if there is no plan, and provide discharge instructions to the patient and the patient's caregiver as necessary when the patient is discharged home.
We propose to remove the requirements at 42 CFR 416.41(b)(3), “Standard: Hospitalization.” This would address the competition barriers that currently exist in some situations where hospitals providing outpatient surgical services refuse to sign written transfer agreements or grant admitting privileges to physicians performing surgery in an ambulatory surgical center (ASC). The Emergency Medical Treatment and Labor Act emergency response regulations would continue to address emergency transfer of a patient from an ASC to a nearby hospital.
We propose to remove the current requirements at § 416.52(a) and replace them with requirements that defer, to a certain extent, to the ASC policy and operating physician's clinical judgment to ensure that patients receive the appropriate pre-surgical assessments tailored to the patient and the type of surgery being performed. We still would require the operating physician to document any pre-existing medical conditions and appropriate test results, in the medical record, which would have to be considered before, during and after surgery. In addition, we have retained the requirement that all pre-surgical assessments include documentation regarding any allergies to drugs and biologicals, and that the medical history and physical examination (H&P), if completed, be
We have concluded that the requirements at 42 CFR 418.106(a)(1), related to having on the hospice staff, an individual with specialty knowledge of hospice medications, is no longer necessary for various reasons. Therefore, we propose to remove these requirements.
In addition, we propose to replace the requirement that hospices provide a copy of medication policies and procedures to patients, families and caregivers with a requirement that hospices provide information regarding the use, storage, and disposal of controlled drugs to the patient or patient representative, and family. This information would be provided in a more user-friendly manner, as determined by each hospice. We believe this could improve patients' and caregivers' comprehension and maximize the effectiveness of the education effort.
We propose to move the requirements at § 418.112(f) to the “Written agreement” standard at new § 418.112(c)(10). Moving the requirement for facility staff orientation from a standalone requirement that places responsibility solely on hospices to the section of the rule related to the written agreement established between hospices and skilled nursing facilities (SNFs) and intermediate care facilities for individuals with intellectual disabilities (ICFs/IID) will allow both entities to negotiate the terms for assuring orientation of facility staff. This will give hospices more freedom to develop innovative approaches and avoid effort duplication with other hospices that are orienting the same facility staff.
We propose a new standard at 42 CFR 482.21(f), “Unified and integrated QAPI program for multi-hospital systems.” We would allow a hospital that was part of a hospital system consisting of multiple separately certified hospitals using a system governing body that was legally responsible for the conduct of two or more hospitals, the system governing body could elect to have a unified and integrated Quality Assessment and Performance Improvement (QAPI) program for all of its member hospitals after determining that such a decision was in accordance with all applicable State and local laws. The system governing body is responsible and accountable for ensuring that each of its separately certified hospitals meets all of the requirements of this section. Each separately certified hospital within the system would have to demonstrate that: The unified and integrated QAPI program was established in a manner that takes into account each member hospital's unique circumstances and any significant differences in patient populations and services offered in each hospital; and the unified and integrated QAPI program would establish and implement policies and procedures to ensure that the needs and concerns of each of its separately certified hospitals, regardless of practice or location, were given due consideration, and that the unified and integrated QAPI program would have mechanisms in place to ensure that issues localized to particular hospitals were duly considered and addressed.
We propose to allow hospitals the flexibility to establish a medical staff policy describing the circumstances under which such hospitals could utilize a pre-surgery/pre-procedure assessment for an outpatient, instead of a comprehensive medical history and physical examination (H&P). We believe that the burden on the hospital, the practitioner, and the patient could be greatly reduced by allowing this option. In order to exercise this option, a hospital would need to document the assessment in a patient's medical record. The hospital's policy would have to consider patient age, diagnoses, the type and number of surgeries and procedures scheduled to be performed, comorbidities, and the level of anesthesia required for the surgery or procedure; nationally recognized guidelines and standards of practice for assessment of specific types of patients prior to specific outpatient surgeries and procedures; and applicable state and local health and safety laws.
We propose a new standard at § 482.42(c), “Unified and integrated infection control program for multi-hospital systems.” Like the proposed requirements for a unified and integrated QAPI program, the proposed standard for infection control would allow a hospital that is part of a hospital system consisting of multiple separately certified hospitals using a system governing body that is legally responsible for the conduct of two or more hospitals, the system governing body can elect to have a unified and integrated infection control program for all of its member hospitals after determining that such a decision is in accordance with all applicable State and local laws. The system governing body is responsible and accountable for ensuring that each of its separately certified hospitals meets all of the requirements of this section. Each separately certified hospital within the system must demonstrate that: The unified and integrated infection control program is established in a manner that takes into account each member hospital's unique circumstances and any significant differences in patient populations and services offered in each hospital; the unified and integrated infection control program establishes and implements policies and procedures to ensure that the needs and concerns of each of its separately certified hospitals, regardless of practice or location, are given due consideration, and that the unified and integrated infection control program has mechanisms in place to ensure that issues localized to particular hospitals are duly considered and addressed; and a qualified individual (or individuals) has been designated at the hospital as responsible for communicating with the unified infection control program and for implementing and maintaining the policies and procedures governing infection control as directed by the unified infection control program.
We propose at § 482.61(d) to clarify the scope of authority for non-physician practitioners or Doctor of Medicine Doctor of Osteopathic Medicine (MD/DOs) to document progress notes of patients receiving services in psychiatric hospitals.
We are proposing a nomenclature change at part 482 and the transplant center regulations at §§ 482.68, 482.70, 482.72 through 482.104, and at § 488.61. This change would update the terminology used in the regulations to conform to the terminology that is widely used and understood within the transplant community, thereby reducing provider confusion.
We propose to remove the requirements at § 482.82 that require transplant centers to submit clinical experience, outcomes, and other data in order to obtain Medicare re-approval. Transplant centers will still be required to comply with the CoPs at §§ 482.72 through 482.104 and the data submission, clinical experience, and outcome requirements for initial Medicare approval under § 482.80.
We propose to remove the requirements at § 488.61(f) through (h) with respect to the re-approval process for transplant centers. This change corresponds to the proposed removal of the provisions § 482.82.
We propose to remove the requirements for verbal (meaning spoken) notification of patient rights to those patient rights elements for which the Social Security Act (the Act) requires such verbal notification. Specifically, we propose to only require verbal notice for those rights related to payments made by Medicare, Medicaid, and other federally funded programs, and potential patient financial liabilities.
We propose to revise § 486.104, “Condition for coverage: Qualifications, orientation and health of technical personnel”, to align the current requirements at § 486.104(a)(1), (2), (3), (4) with § 482.26(c)(2), which refers to qualifications of radiologic technologists in hospitals and is focused on the qualifications of the individual performing services.
We propose to revise the requirements for portable x-ray orders at § 486.106(a)(2). We propose to remove the requirement that physician or non-physician practitioner's orders for portable x-ray services must be written and signed. We also propose to replace the specific requirements related to the content of each portable x-ray order with a cross-reference to the requirements at 42 CFR 410.32, which also apply to portable x-ray services. These proposed changes would simplify the ordering process for portable x-rays and promote the use of more efficient ordering methods, such as electronic orders.
We propose to eliminate part of the requirement from § 482.15(a)(4) for hospitals and other parallel provisions for other affected Medicare and Medicaid providers and suppliers (referred to collectively as “facilities,” throughout the remainder of this proposed rule where applicable), that facilities document efforts to contact local, tribal, regional, State, and Federal emergency preparedness officials, and that facilities document their participation in collaborative and cooperative planning efforts. In accordance with the remaining requirement at § 482.15(a)(4), facilities would still be required to include a process for cooperation and collaboration with local, tribal, regional, State and Federal emergency preparedness officials' efforts to maintain an integrated response during a disaster or emergency situation. Only the documentation requirements would be eliminated.
We propose to remove the requirement that Home Health Agencies (HHAs) provide a copy of the clinical record to a patient, upon request, by the next home visit. We propose to retain the requirement that the copy of the clinical record must be provided, upon request, within 4 business days.
We propose to change the requirement at § 485.635(a)(4) to reflect the current medical practice where providers are expected to update their policies and procedures as needed in response to regulatory changes, changes in the standard of care, or nationally recognized guidelines. The current CoP at § 485.635(a)(4) requires a CAH's professional personnel to review its policies at least annually and the CAH to review as necessary. We propose to reduce burden and provide flexibility by requiring the CAH's, professional personnel, at a minimum, to conduct a biennial review of its policies and procedures instead of an annual review.
We propose to amend the utilization review plan requirements at § 485.66 to reduce the frequency of utilization reviews from quarterly to annually. This would allow an entire year to collect and analyze data to inform changes to the facility and the services provided.
We propose to remove the requirement that all Community Mental Health Center (CMHC) clients receive an updated assessment every 30 days. Instead, we would require updates of the patient assessment in accordance with client needs and standards of practice. For clients receiving partial hospitalization services, we propose to retain the 30 day assessment update time frame in accordance with existing Medicare payment requirements for partial hospitalization services.
We propose to revise the requirement at § 491.9(b)(4) that RHC and FQHC patient care policies are reviewed at least annually by a group of professional personnel to review every other year to reduce the frequency of policy reviews.
We propose to revise the requirement at § 491.11(a) by changing the frequency of the required RHC or FQHC evaluation from annually to every other year.
On September 16, 2016, we finalized a rule imposing emergency preparedness requirements on most Medicare and Medicaid facilities (Emergency Preparedness Requirements for Medicare and Medicaid Participating Providers and Suppliers, 81 FR 63860). Facilities participating in Medicare and/or Medicaid are now required, among other things, to review their emergency preparedness programs annually. This includes a review of their emergency plans, policies and procedures, communication plans, and training and testing programs. We propose to revise these requirements, so that applicable providers and suppliers have increased flexibility with compliance.
As with the review of the emergency plan previously discussed, we propose to revise the requirement that facilities develop and maintain a training program based on the facility's emergency plan annually. Instead, we would require that facilities provide training biennially (every 2 years) after facilities conduct initial training for their emergency program. In addition, we propose to require additional training when the emergency plan is significantly updated.
For inpatient providers, we propose to expand the types of acceptable testing exercises that may be conducted such that one of the two annually required testing exercises may be an exercise of their choice, which may include one community-based full-scale exercise, if available, an individual facility-based functional exercise, a drill, or a tabletop exercise or workshop that includes a group discussion led by a facilitator. For outpatient providers, we propose to revise the requirement such that only one testing exercise is required annually, which may be either one community-based full-scale exercise, if available, or an individual facility-based functional exercise, every other year and in the opposite years, these providers may chose the testing exercise of their choice which may include a community-based full-scale exercise, if available, a facility-based functional exercise, a drill, or a tabletop exercise or workshop that includes a group discussion led by a facilitator.
We propose to revise § 418.76(a)(1)(iv) to remove the requirement that a State licensure program meet the specific training and competency requirements set forth in § 418.76(b) and (c) in order for such licensure to qualify a hospice aide to work at a Medicare-participating hospice. We would defer to State licensure requirements regardless of their content or format, and would allow states to set forth training and competency requirements that meet the needs of their populations. We believe that this change would streamline the hiring process for most hospices.
We propose to remove the requirement for hospitals at § 482.22(d), which states that a hospital's medical staff should attempt to secure autopsies in all cases of unusual deaths and of medical-legal and educational interest. We propose to instead defer to State law regarding such medical-legal requirements.
We propose to remove the cross reference to § 483.10(f)(9) at § 482.58(b)(1) (for hospital swing-bed providers) and § 485.645(d)(1) (for CAH swing-bed providers). The cross-reference gives a resident the right to choose to, or refuse to, perform services for the facility if they so choose. If the resident works, the facility must document it in the resident's plan of care, noting whether the services are voluntary or paid, and, if paid, providing wages for the work being performed, at prevailing rates.
We propose to remove the cross-reference to § 483.24(c) at § 482.58(b)(4) (for hospital swing-bed providers) and § 485.645(d)(4) (for CAH swing-bed providers). This cross reference requires that the facility provide an ongoing activity program based on the resident's comprehensive assessment and care plan directed by a type of qualified professional specified in the regulation.
We propose to remove the cross-reference to § 483.70(p) at § 482.58(b)(5) (for hospital swing-bed providers) and § 485.645(d)(5) (for CAH swing-bed providers requiring facilities with more than 120 beds to employ a social worker on full-time basis).
We propose to remove the cross-reference to § 483.55(a)(1) at § 482.58(b)(8) (for hospital swing-bed providers) and § 485.645(d)(8) (for CAH swing-bed providers) requiring that the facility assist residents in obtaining routine and 24-hour emergency dental care.
We propose to revise the requirement at § 418.76(h) related to completing a full competency evaluation when an aide is found to be deficient in one or more skills. Instead of completing a full competency evaluation, an aide would only be required to complete retraining and a competency evaluation directly related to the deficient skills.
We propose to remove § 485.627(b)(1), the requirement for CAHs to disclose the names of people with a financial interest in the CAH. This is currently a requirement under the program integrity requirements at 42 CFR 420.206, which are referenced in the provider agreement rules in 42 CFR 489.53(a)(8). The provider agreement rules note that the basis for termination of the provider agreement includes failure of the provider to furnish ownership information as required in § 420.206, making this CAH CoP requirement duplicative of those regulations.
This proposed rule would create savings and reduce burden in many areas. Several of the proposed changes would create measurable monetary savings for providers and suppliers, while others would create less quantifiable savings of time and administrative burden. We estimate a total annual savings of $1,123 million using the midpoints of estimated ranges. We also estimate a one-time implementation cost of $64 million.
Table 1 summarizes the provisions for which we are able to provide specific estimates for savings or burden reductions (these estimates are uncertain and could be substantially higher or lower, as explained in the regulatory impact analysis section of this proposed rule):
Section 1861(ss)(1) of the Act defines the term “Religious Nonmedical Health Care Institution” (RNHCI) and lists the requirements that a RNHCI must meet to be eligible for Medicare participation. We have implemented these provisions in 42 CFR part 403, subpart G, “Religious Nonmedical Health Care Institutions Benefits, Conditions of Participation, and Payment.” Currently there are 18 Medicare-certified RNHCIs that are subject to the RNHCI regulations.
A RNHCI provides only non-medical items and services through non-medical nursing personnel on a 24-hour basis. These services are provided to beneficiaries who choose to rely solely upon a religious method of healing and for whom the acceptance of medical services would be inconsistent with their religious beliefs. “Religious non-medical care” or “religious method of healing” means care provided under established religious tenets that prohibit conventional or unconventional medical care for the treatment of the patient, and exclusive reliance on religious activity to fulfill a patient's total healthcare needs. The RNHCI does not furnish medical screening, examination, diagnosis, prognosis, treatment, or the administration of drugs or biologicals to its patients.
Section 403.736(a) and (b) of the RNHCI's CoPs, as amended in the November 28, 2003
Currently, § 403.736(a)(1) requires RNHCIs to assess the need for a discharge plan for any patient identified as likely to suffer adverse consequences if there is no planning and for any other patient upon his or her request or at the request of his or her legal representative. In accordance with § 403.736, this discharge planning evaluation must be initiated at admission and must include the following:
• An assessment of the possibility of a patient needing post-RNHCI services and of the availability of those services.
• An assessment of the probability of a patient's capacity for self-care or of the possibility of the patient being cared for in the environment from which he or she entered the RNHCI.
• The staff must complete the assessment on a timely basis so that arrangements for post-RNHCI care are made before discharge and so that unnecessary delays in discharge are avoided.
• The discharge planning evaluation must be included in the patient's care record for use in establishing an appropriate discharge plan. Staff must discuss the results of the discharge planning evaluation with the patient or a legal representative acting on his or her behalf.
• If the discharge planning evaluation indicates a need for a discharge plan, qualified and experienced personnel must develop or supervise the development of the plan.
• In the absence of a finding by the RNHCI that the beneficiary needs a discharge plan, the beneficiary or his or her legal representative may request a discharge plan. In this case, the RNHCI must develop a discharge plan for the beneficiary.
• The RNHCI must arrange for the initial implementation of the beneficiary's discharge plan.
• If there are factors that may affect continuing care needs or the appropriateness of the discharge plan, the RNHCI must reevaluate the beneficiary's discharge plan. The RNHCI must inform the beneficiary or legal representative about the beneficiary's post-RNHCI care requirements.
• The discharge plan must inform the beneficiary or his or her legal representative about the freedom to choose among providers of care when a variety of providers is available that are willing to respect the discharge preferences of the beneficiary or legal representative.
Since the RNHCI's religious tenets prohibit conventional or unconventional medical treatment of a beneficiary, we believe that the extensive requirements previously discussed are unnecessarily burdensome, because medical post-institution services are not utilized by RNHCI patients.
Based on our experience with RNHCIs, patients are routinely discharged to home and not to an acute or post-acute care medical provider or supplier. We do not see a need for RNHCIs to develop a discharge plan that includes medical care once a patient leaves the RNHCI, because doing so is not in keeping with the religious tenets and goals of the facility. However, we believe that it is important to discuss with the caregiver at home about a safe and healing environment at home and to monitor the individual to access any changes in the patient's well-being and the need to seek additional care. We would expect RNHCIs to have policies and procedures that address their discharge processes. If the RNHCI determines that a patient either does or does not require discharge instructions, this decision must be made based on the RNHCI's existing policies. Surveyors would be expected to review the RNHCI policies and confirm that either the existence or lack of discharge instructions is consistent with policies established by the RNHCI.
We propose a more condensed and flexible process for discharge planning and instructions for RNHCIs. Specifically, we propose to remove the requirements at § 403.736(a) and (b), proposing instead to require RNHCIs to provide discharge instructions to the patient and/or the patient's caregiver when the patient is discharged home. We also propose that paragraphs (c) and (d) be redesignated as paragraphs (b) and (c).
We seek to reduce burdens for health care providers and patients, improve the quality of care, decrease costs, and ensure that patients and their providers and physicians are making the best health care choices possible. Therefore, we are soliciting public comments on additional regulatory reforms for burden reduction for future rulemaking. Specifically, we are seeking public comment on additional proposals or modifications to the proposals set forth in this rule that would further reduce burden on RNHCIs and create cost savings, while also preserving quality of care and patient health and safety. Consistent with our “Patients Over Paperwork” Initiative, we are particularly interested in any suggestions to improve existing requirements, within our statutory authority, where they make providing quality care difficult or less effective.
We also note that such suggestions could include or expand upon comments submitted in response to the FY 2018 Hospital Inpatient Prospective Payment System for Acute Care Hospitals and the Long-Term Care Hospital Prospective Payment System RFI, found at
The most useful comments will be those that include data or evidence to support the position, offer suggestions to amend specific sections of the existing regulations, or offer particular additions.
Section 416.2 defines an ambulatory surgical center (ASC) as any distinct entity that operates exclusively for the purpose of providing surgical services to patients not requiring hospitalization, in which the expected duration of services would not exceed 24 hours following an admission. The surgical services performed at ASCs are scheduled, primarily elective, non-life-threatening procedures that can be safely performed in an ambulatory setting. Currently, there are 5,591 Medicare certified ASCs in the United States.
Section 1832(a)(2)(F)(i) of the Act specifies that ASCs must meet health, safety, and other requirements specified by the Secretary in regulation in order to participate in Medicare. The Secretary of the Department of Health and Human Services (the Secretary) is responsible for ensuring that the CfCs protect the health and safety of all individuals treated by ASCs, whether they are Medicare beneficiaries or other patients.
The ASC regulations were first published on August 5, 1982 (47 FR 34082) and have since been amended several times. On November 18, 2008, we published a final rule, entitled “Medicare Program: Changes to the Ambulatory Surgical Center Conditions for Coverage”, (73 FR 68502) revising four existing health and safety CfCs and created three new health and safety CfCs. In addition, several other small changes have been made in the past several years to amend the emergency equipment requirements (77 FR 29002) and radiologic services requirements required in the ASCs (79 FR 27106).
Section 416.41(b) outlines the patient hospitalization procedures that ASCs must have in place to participate in Medicare. Section 416.41(b)(1) states the ASC must have an effective procedure for the immediate transfer, to a hospital, of patients requiring emergency medical care that surpass the capabilities of the ASC. Additionally, there are two requirements that also pertain to ASC patient hospital transfers. Section 416.41(b)(3)(i) and (ii) requires ASCs to have a written transfer agreement with a hospital that meets certain Medicare requirements or ensure all physicians performing surgery in the ASC have admitting privileges in a hospital that meets certain Medicare requirements. A written transfer agreement and physician admitting privileges is intended to make sure there is a relationship between the ASC and local hospital that would serve the patient in the event of a medical emergency. Over the past 5 years, we have heard from the largest ASC trade association and multiple ASCs that we need to address the widespread issue of the growing number of hospitals that are declining to work with ASCs (either by declining to sign a transfer agreement or by declining to allow admitting privileges to the hospital by physicians who work in ASCs) due to competition between hospital outpatient surgery departments and ASCs. CMS has continually worked with the ASCs and hospitals directly to resolve this requirement issue, however, several facilities have not been able to reach a positive outcome. Furthermore, we have seen no evidence of negative patient outcomes due to a lack of such transfer agreements and admitting privileges. Research reports published by the ASC Quality Collaborative indicate the national hospital transfer rate from an ASC to a hospital for care is about 1.25 per 1,000 ASC admissions (
EMTALA was enacted in 1986 and as its enforcement evolved over time this effectively has rendered such transfer agreements unnecessary, since EMTALA imposed requirements on all hospitals to provide emergency care without regard to prior arrangements until a patient could be stabilized and, as appropriate, either discharged because further care was not necessary, or transferred to another facility or care arrangement. Therefore, we conclude that these requirements are creating an administrative barrier to efficient ASC operations without any improvement in patient care or safety. In the absence of a transfer agreement or admitting privileges, ASCs would continue to have access to local emergency services to transfer patients to the nearest appropriate hospital for continued care. Hospitals are required to provide appropriate screening and stabilizing treatment for patients experiencing emergency medical conditions in accordance with the regulations set forth at § 489.24.
In light of these factors, we propose to remove the requirement for a written hospital transfer agreement or hospital physician admitting privileges at § 416.41(b)(3). We believe the proposed changes to the ASC hospitalization standard requirements would streamline ASC administrative operations and still assure the safety of these services while being less burdensome for Medicare-certified ASC facilities. The requirements in § 416.41(b)(1) and (2) continue to require the ASC to have an effective procedure for the immediate transfer, to a hospital, of patients requiring emergency medical care beyond the capabilities of the ASC and that the hospital must be a local hospital that meets the requirements for payment for emergency services under § 482.2. As part of this effective procedure, ASCs are not precluded from obtaining a hospital transfer agreements or hospital physician admitting privileges when possible. We would also like to solicit comments on burden that may result from the absence of a transfer agreement between ASCs and hospitals.
The current regulations at § 416.52 require ASCs to ensure that a physician or other qualified practitioner provide a comprehensive medical history and physical assessment completed not more than 30 days before the date of the scheduled surgery. We have received feedback from stakeholders that the current requirement is overly burdensome for a large majority of healthy patients, specifically those patients who are receiving minimally invasive surgical procedures that are performed under minimal sedation or local anesthesia alone. For example, cataract surgery is the most commonly performed ASC surgical procedure among Medicare beneficiaries. Modern cataract surgery is a short procedure using mild sedation and local anesthesia. Medical complications for cataract surgery before, during and after surgery are extremely rare. Other ophthalmic procedures, such as Yttrium-Aluminum Garnet (YAG) laser capsulotomy, does not require a local
The vast majority of outpatient surgeries are performed on an outpatient or “ambulatory” basis precisely because they involve extremely low risk of complications due either to preexisting conditions or to the risk of the surgical procedure itself. Most such procedures are among those that are also routinely performed in physician offices. We further note that the specification of any short time period for the acceptability of pre-surgical evaluations (in other words, within 30 days) is inherently arbitrary and burdensome for the ASC patient population. For example, in the case of a cataract patient who needs a procedure in both eyes, a 31-day delay between the two operations would trigger the need for another physical examination and, possibly, another set of laboratory tests. Likewise, if an unanticipated event such as a death in the family required delaying a procedure by more than the 30th day after the examination, a duplicative examination and any necessary tests would be required. Moreover, if the examination and tests had been performed timely, but the results not transmitted in time, the duplicative examination and tests would be required.
We propose to remove the current requirements at § 416.52(a) and replace them with requirements that defer to the facility's established policies for pre-surgical medical histories and physical examinations (including any associated testing) and the operating physician's clinical judgment, to ensure patients receive the appropriate pre-surgical assessments that are tailored for the patient and the type of surgery being performed. We propose to require each ASC to establish and implement a policy that identifies patients who require an H&P prior to surgery. We propose that the policy would include the time frame for the H&P to be completed prior to surgery. ASCs may choose to continue the 30 day policy that has existed in regulation since 2008, or may choose a different time frame based on available evidence and standards of practice. We propose that the policy would be required to consider the age of patients, their diagnoses, the type and number of surgeries that are scheduled to be performed at one time, all known comorbidities, and the planned level of anesthesia for the surgery to be performed. ASCs would not be limited to these factors, and would be permitted to include others to meet the needs of their patient populations. Furthermore, we propose that each ASC's policy would be required to follow nationally recognized standards of practice and guidelines, as well as applicable state and local health and safety laws.
Particular subgroups of patients may benefit from more extensive and complete medical history and physical assessments prior to surgery. Those subgroups, for example, might include patients who cannot lie supine, have chest pain or shortness of breath, have pacemakers, have had a recent heart attack, on dialysis, or take insulin (Schein OD, Pronovost PJ. A Preoperative Medical History and Physical Should Not Be a Requirement for All Cataract Patients. DOI: 10.1007/s11606-017-4043-9, March 20, 2017.)
We would retain the requirement that the physician performing the surgery or other qualified practitioner perform a pre-surgical assessment for each ASC patient, including documentation regarding any allergies to drugs and biologicals. We would also retain the requirement that any documentation related to the H&P that may have been performed would be placed in the patient's medical record prior to the surgical procedure.
Our proposed change would simply eliminate the requirement for a pre-operative H&P, while allowing patient-specific physician decisions and ASC-wide policy decisions to determine what examinations and tests are necessary for each patient. Such decisions could be informed by specialty societies, medical literature, past experience, or other factors. We believe the proposed changes will reduce burden and provide flexibility for patients while maintaining a balance of health and safety requirements for providers.
In reading the discussion that follows, it is important to understand that the requirement for making a patient assessment at the ASC, on the day of surgery and before surgery commences, remains unchanged. This assessment addresses any new surgical risks for the patient with procedure-specific or patient-specific questions (for example, has the patient had a fever in the last 24 hours or, for a patient with diabetes, have there been any recent changes to random blood glucose levels with at-home monitoring?). The questions focus on any recent changes or updates to the patient's condition since the last H&P that might adversely impact the outcome of the procedure for the patient. This assessment must occur before proceeding with the procedure. Furthermore, we are not proposing to eliminate or discourage comprehensive pre-surgical H&Ps where warranted. To replace the current arbitrary 30-day rule applying to all patients, regardless of procedure or risk, we propose that each facility make an independent determination as to which procedures and which patient profiles would dictate requiring a pre-operative history and examination, taken before (but not necessarily 30 days before and possibly many months before) the day of surgery.
We request comment on whether we should make exceptions, such as for particular patient conditions or surgical procedures, that should not be entitled to such broad discretion, and for any evidence that would support such exceptions. We would also be interested in knowing if particular examinations or tests should be normal for those
The current regulations at § 416.47 require ASCs to maintain complete, comprehensive, and accurate medical records to ensure adequate patient care. Section 416.47(b) sets out the form and content of the record, including specific items that must be included in the medical record. To conform to the proposed changes to the medical history and physical examination requirements at § 416.52(a), we propose to revise the requirement at § 416.47(b)(2) that states “Significant medical history and results of physical examination”, by adding “as applicable.” This proposed revision would reflect the fact that, in accordance with our proposed changes to § 416.52(a), not all ASC patients may have a medical history and physical examination report that would be included in the medical record.
We seek to reduce burdens for health care providers and patients, improve the quality of care, decrease costs, and ensure that patients and their providers and physicians are making the best health care choices possible. Therefore, we are soliciting public comments on additional regulatory reforms for burden reduction in future rulemaking. Specifically, we are seeking public comment on additional proposals or modifications to the proposals set forth in this rule that would further reduce burden on ASCs and create cost savings, while also preserving quality of care and patient health and safety. Consistent with our “Patients Over Paperwork” Initiative, we are particularly interested in any suggestions to improve existing requirements, within our statutory authority, where they make providing quality care difficult or less effective. We also note that such suggestions could include or expand upon comments submitted in response to the RFI that was included in the CY 2018 OPPS/ASC proposed rule. Public comments in response to this RFI can be found at the following link:
The most useful comments will be those that include data or evidence to support the position, offer suggestions to amend specific sections of the existing regulations, or offer particular additions.
Under the current hospice CoP requirements at § 418.76, all hospice aides are required to meet specific, federally-established, training and education requirements. The requirements are based on the training and education requirements for home health aides as set forth at section 1891(a)(3)(D) and 1861(m)(4) of the Act. Specifically, the current CoPs (§ 418.76(a)) require that a hospice aide must be a person who has completed one of the following: A training program and competency evaluation as specified in the regulations; a competency evaluation program that meets the requirements specified in the regulation; a nurse aide training and competency evaluation program in accordance with the requirements set forth in the long term care requirements; or a State licensure program that meets the requirements at § 418.76(b) (training) and (c) (competency evaluation). At § 418.76(b) and (c) of the hospice CoPs, we specifically detail the content and format of aide education, training, and of competency evaluations, including the number of classroom and practical training hours that must be completed, the skills that must be addressed, and the general method (exam or practical observation) used for assessing competency in those various skills.
We initially proposed and finalized these requirements in order to be consistent with the requirements that apply to home health aides (§ 484.80). Historically, a significant number of hospice agencies were HHA-based, meaning that the same entity provides both hospice and home health care services, often utilizing the same pool of staff to furnish both services. Using similar requirements for both hospices and home health agencies streamlines operations for hospices that are home health agency based. Due to the evolution of the hospice industry as a whole, the proportion of HHA-based hospices has significantly declined, reducing the streamlining benefits that occur by having the same requirements for aides in both hospice and home health settings.
As the streamlining benefits for the hospice industry as a whole have reduced, the burden/benefit ratio related to meeting the prescriptive home health aide qualification requirements, which are required to be set forth in regulation by section 1891(a) of the Act, has shifted. While section 1891(a) of the Act requires CMS to establish prescriptive requirements for aides who provide services on behalf of home health agencies, the Act does not establish similarly prescriptive requirements for aides who provide services on behalf of hospices. In addition to the hospice aide qualifications that are established in the hospice CoPs, hospice aides must also be licensed, certified, or registered by the State in which they are practicing (if available), in accordance with the requirements at § 418.116(a). A hospice industry association conducted an informal survey of all 50 states and found that 76 percent of those states currently have their own hospice aide qualifications for licensure, certification, or registration. Therefore, we assume that in 76 percent of states, hospice aides are required to meet two different qualification standards (one for state licensure, certification, or registration; and one for compliance with the Federal CoPs).
This regulatory approach has created unintentional burden during the hiring process for all of the non HHA-based hospices, as well as those HHA-based hospices that do not share staff with the home health agency portion of their organization. The unintentional burden is the result of hospices having to verify during the aide hiring process that the applicant meets both the state licensure, certification, or registration requirements, and also meets the specific training and competency requirements set forth in the CoPs. State requirements may change at any time and hospices may receive employment applications from aides that have been trained in another setting such as nurse aide training in the long term care environment or private duty aide training not subject to Federal regulations, so hospices are burdened with the need to review, in detail, each employment applicant's training and competency content and format each time they need to make a new hire. For example, State requirements may specify a different number of training hours to be completed, a different format for assessing competency in a specific skill, or even a different set of mandatory skills in accordance with State scope of practice requirements. We believe that this is an unnecessary and inefficient use of hospice staff time that does not serve to improve patient care and safety.
To address these concerns, we propose to revise § 418.76(a)(1)(iv) to remove the requirement that a State licensure program must meet the specific training and competency requirements set forth in § 418.76(b) and
The June 5, 2008 Hospice CoP final rule (73 FR 32088) required hospices to ensure that the interdisciplinary group confers with an individual with education and training in drug management as defined in hospice policies and procedures and State law, who is an employee of or under contract with the hospice to ensure that drugs and biologicals meet each patient's needs (§ 418.106(a)(1)). This requirement was implemented as a direct result of public comments that were submitted in regards to the May 2005 Hospice CoP proposed rule (70 FR 30840). The May 2005 Hospice CoP proposed rule proposed to retain longstanding requirements for pharmacist involvement in the planning and delivery of drugs and biologicals for patients that receive care in the hospice inpatient setting. Commenters suggested that we broaden our proposal and apply it to patients receiving care in all settings. The commenters stated that, since drugs are prescribed to virtually all hospice patients, these patients should benefit from the expertise of a pharmacist and the additional level of drug oversight required by the regulatory standards. We agreed with the commenters that it would be beneficial to patients to broaden the scope of the pharmacy requirements. For this reason, we finalized a requirement at paragraph (a), “Managing drugs and biologicals,” to require that each hospice ensures that the interdisciplinary group confers with an individual with education and training in drug management as defined in hospice policies and procedures and State law, who is an employee of or under contract with the hospice to ensure that drugs and biologicals meet each patient's needs. Hospices have the option of using a licensed pharmacist or an individual who has an extensive and up-to-date knowledge of drugs, to fulfill this role.
At the time when this requirement was finalized in 2008, we estimated that 1,600 hospices (56 percent of all hospices) were already contracting with pharmacy benefit management companies to provide drugs and pharmacist services to each of their patients at a single bundled service rate. These hospices were already realizing the benefits of specialized drug management expertise in the absence of Federal regulations. Since 2008, the use of pharmacy benefit management companies, including their built-in pharmacy experts, has continued to grow at a rapid pace. Although there have been no formal studies on the proliferation of pharmacy benefit management company use in hospice, conversations with industry experts lead us to estimate that, at minimum, 75 percent of existing hospices use such services. Experts estimate that the more likely number is between 90 and 95 percent of hospices due to various factors that hospices find to be desirable, such as predictable capitated medication fees and direct to the patient door medication delivery services. Since the use of pharmacology experts has become routine due to the proliferation of pharmacy benefit management companies that provide pharmacist services for each patient bundled with drug and biologics supply services, we believe that it is no longer necessary to include a regulatory requirement specifically related to the use of a pharmacology expert. As pharmacy benefit management services bundle drug and biologics supply services with expert advice, and since industry experts estimate that at least 75 percent and as many as 95 percent of hospices use pharmacy benefit management services for reasons primarily unrelated to this specific regulatory requirement, we conclude that the vast majority of hospices, and thus the vast majority of hospice patients, will continue to receive such advice and guidance in the absence of regulation. This proposed change would allow hospices to more seamlessly integrate the information provided by the drug management expert into routine interdisciplinary group meetings rather than having to use burdensome formulaic approaches that hospices currently implement in order to demonstrate compliance with the regulation.
In addition to changes in the pharmacy benefit management landscape, there have also been significant changes in the hospice and palliative care nursing and physician landscapes. Since publication of the 2008 Hospice CoP final rule (73 FR 32088), the number of hospice and palliative care nursing and physician specialty training and certification programs has rapidly expanded. As more hospice and palliative care
Hospices would continue to be required to comprehensively assess patients on a regular schedule and on an as needed basis (§ 418.54(a), (b) and (d)), and to assure that each patient's plan of care is developed and continually updated to meet each patient's needs as identified in the assessment process (§ 418.56(b) through (d)). To the extent that a hospice needs additional expert information or expertise beyond what is provided by hospice employees and the pharmacy expertise of any pharmacy benefit manager that a hospice may choose to use in order to meet a given patient's assessment, care planning, and care delivery medication-related needs, we would continue to require that it secure such information and expertise. Meeting each patient's needs would continue to be the responsibility of all Medicare-participating hospices in accordance with the requirements of all other hospice CoPs.
The 2008 Hospice CoP final rule (73 FR 32088) also required hospices, at § 418.106(e)(2)), to: (1) Provide a copy of the hospice written policies and procedures on the management and disposal of controlled drugs to the patient or patient representative and family; (2) discuss the hospice policies and procedures for managing the safe use and disposal of controlled drugs with the patient or representative and the family in a language and manner that they understand to ensure that these parties are educated regarding the safe use and disposal of controlled drugs; and (3) document in the patient's clinical record that the written policies and procedures for managing controlled drugs was provided and discussed. We believe that the hospice, as well as the patient, family, and caregivers share the responsibility and accountability for maintaining controlled substances in the home. We believe that hospices must assume responsibility to educate the patient and family about the proper use and disposal of controlled drugs and biologicals that are maintained in the home environment. The drug policies and procedures also help the hospice explain its own role in controlled drug management.
We believe that this requirement continues to be relevant, particularly in relationship to implementing proper storage and security precautions that can prevent theft and other drug diversion in the home, and proper disposal when a drug is no longer needed to prevent inappropriate access and environmental damage. Therefore, we continue to expect that hospices would have such policies and procedures for their own internal use as part of routine business practice. However, hospice policies and procedures are typically written in ways that are not easily understood by the general public. Hospice clinicians spend more time than expected explaining technical terms and otherwise translating the policies and procedures into layperson's terms. We do not believe that this process of explaining complex documents in a manner that is meaningful to patients and families is beneficial to patients, families, caregivers, or hospices.
We propose to replace the requirement that hospices provide a physical paper copy of policies and procedures, which are written to guide the actions of hospice staff, with a requirement that hospices provide information regarding the use, storage, and disposal of controlled drugs to the patient or patient representative, and family, which can be developed in a manner that speaks to the perspectives and information needs of patients and families. This information would be provided in a more user-friendly manner, as decided by each hospice, which we believe can improve comprehension and maximize the effectiveness of the education effort. Furthermore, by providing information in a more user-friendly manner, hospices would be able to eliminate time spent explaining technical terms and other otherwise translating the policies and procedures into layperson's terms. This would create more efficiency while simultaneously improving hospice-patient communications. Hospices would be free to choose the content and format(s) that best suits their needs and the needs of their patient population. We propose to require that, regardless of the format chosen, this information must be provided to patients and families in a manner that allows for continual access to the information on an as-needed basis in order to assure that patients and families have information available when they need it. CMS is soliciting input concerning what a standardized educational format should entail, including whether the format should be paper or electronic; in writing, pictorial, video, or audio; what general subjects should be addressed in regards to storage, disposal, use, and risks; and what specific content should be included to minimize opioid diversion and maximize safety.
We would continue to require that hospices discuss the information regarding the safe use, storage and disposal of controlled drugs with the patient or representative, and the family, in a language and manner that they understand to ensure that these parties are effectively educated. This requirement is included in the current hospice CoPs and is consistent with Department of Health and Human Services guidance regarding Title VI of the Civil Rights Act (“Guidance to Federal Assistance Recipients Regarding Title VI Prohibition Against National Origin Discrimination Affecting Limited English Proficient Persons,” 68 FR 47311, August 8, 2003,
Section 418.112(f) of the hospice CoPs, as finalized in the 2008 Hospice CoP final rule (73 FR 32088), requires hospices to assure orientation of Skilled Nursing Facility/Nursing Facility (SNF/NF) or ICF/IID staff furnishing care to
We believe that the intent of the requirement to educate facility staff about hospice care continues to be an appropriate regulatory requirement. However, we believe that, as currently written and implemented, this requirement may create duplication when multiple hospices provide care to the residents of a single facility. Furthermore, by assigning sole responsibility for this effort to hospice providers, this requirement may impede joint hospice-facility collaboration and training innovations. Creating duplicative efforts and impeding collaboration may increase hospice burden without improving the care of hospice patients. Therefore, we believe that it is appropriate to revise the current requirement.
Specifically, we propose to remove § 418.112(f) and add a new requirement at § 418.112(c)(10), “Written agreement,” to address this issue. Moving the requirement for facility staff orientation to the standard related to the written agreement established between hospices and facilities would ensure that both entities negotiate the mechanism and schedule for assuring orientation of facility staff. Additionally, enabling hospices and facilities to negotiate their now shared role would encourage collaboration between both entities, avoid duplication of efforts with other hospices that are orienting the same facility staff, and provide incentives to facilities to become more engaged in the hospice orientation process for facility staff.
We are seeking public comment on all of the proposed hospice changes. In addition, we note that we seek to reduce burdens for health care providers and patients, improve the quality of care, decrease costs, and ensure that patients and their providers and physicians are making the best health care choices possible. Therefore, we are soliciting public comments on additional regulatory reforms for burden reduction in future rulemaking. Specifically, we are seeking public comment on additional proposals or modifications to the proposals set forth in this rule that would further reduce burden on hospices and create cost savings, while also preserving quality of care and patient health and safety. Consistent with our “Patients Over Paperwork” Initiative, we are particularly interested in any suggestions to improve existing requirements, within our statutory authority, where they make providing quality care difficult or less effective. We also note that such suggestions could include or expand upon comments submitted in response to the RFI that was included in the FY 2018 Hospice Wage Index and Payment Rate Update and Hospice Quality Reporting Requirements. Public comments in response to this RFI can be found at the following link:
The most useful comments will be those that include data or evidence to support the position, offer suggestions to amend specific sections of the existing regulations, or offer particular additions.
On May 16, 2012, we published a final rule, entitled “Reform of Hospital and Critical Access Hospital Conditions of Participation” (77 FR 29034). In that rule, we finalized changes to the requirements of the “Governing body” CoP, § 482.12, and adopted a policy to allow one governing body to oversee multiple hospitals in a multi-hospital system. We noted in this rule that the regulations, as finalized, were intended to provide systems that own two or more hospitals with an option, but not a requirement, to use a system governing body for two or more hospitals. In those instances where a system believes that its interests are best served by using a system governing body legally responsible for two or more hospitals, under the CMS regulations, that system will have the flexibility to do so, just as system that owns two or more hospitals will have the flexibility to continue with the model of a separate governing body for each hospital in its system if it determines that course would best serve its interests.
After publication of the May 2012 final rule, we received a considerable amount of feedback regarding our responses in the rule (77 FR 29061) where we discussed our interpretation of the Medical staff CoP at § 482.22 as requiring that each hospital have its own independent medical staff despite the arguable ambiguity of the regulatory language. It was brought to our attention that, over the years, this apparently ambiguous language might have led some stakeholders to interpret § 482.22 as allowing for separately certified hospitals, as members of a multi-hospital system, to share a unified and integrated medical staff. This eventually led to us proposing a requirement in a February 7, 2013 proposed rule, entitled “Regulatory Provisions To Promote Program Efficiency, Transparency, and Burden Reduction—Part II” (78 FR 9216), which proposed to prohibit the use of a unified and integrated medical staff subject to a system governing body.
In the May 12, 2014 final rule, Medicare and Medicaid Programs; Regulatory Provisions To Promote Program Efficiency, Transparency, and Burden Reduction (79 FR 27105) that followed, and after carefully considering all of the arguments for and against allowing a system that owns two or more hospitals to use a unified and integrated medical staff structure for its member hospitals that are subject to a common system governing body, we came to the conclusion that it was in the best interest of hospitals, medical staff members, and patients for us to modify the proposed prohibition on the use of a unified and integrated medical staff for a multi-hospital system and its member hospitals so as to enable the medical staff of each hospital that is subject to a common system governing body to voluntarily integrate itself into a larger system medical staff.
The fact that many hospital systems had been using a unified medical staff model for a number of years, without evidence showing that such a model was detrimental to patients or decreased the quality of care delivered, was a major factor in our decision to allow hospitals and their respective medical staffs the flexibility to decide which medical staff framework worked best for
However, these arguments against allowing this flexibility through the CoPs did not provide any evidence that having a single and separate medical staff for each hospital within a system was inherently superior, particularly in the areas of patient safety and quality of care, to the unified and integrated medical staff model for two or more hospitals subject to a system governing body. We weighed this argument against the comments from the physician leaders and members of unified and integrated medical staffs who provided testimony and anecdotal evidence for the benefits of this type of structure. Additionally, we considered preliminary evidence that appeared to show that hospitals using a unified medical staff might be achieving some success in reducing Hospital-Acquired Conditions (HACs), Healthcare-Associated Infections (HAIs), and readmissions, and in improving patient safety and outcomes. During our preliminary development of this rule, we carefully considered any additional areas where we could provide further flexibility and reduce regulatory burden for hospitals. We were particularly interested in those areas that we had not considered or proposed in the previous rulemaking efforts discussed. As we noted with regard to the use of a unified medical staff model under a system governing body, much of the evidence and testimony provided to us at that time focused on observed improvements in patient safety, quality of care, and overall patient outcomes. In the May 2014 final rule previously referenced, one public commenter, writing on behalf of a multi-hospital system that the commenter references as the largest in their State, stated that “we believe the concept of a single medical staff has substantially contributed to our success as an integrated delivery system and has accelerated our quality, safety and efficiency performance.” The commenter also cited the system's achievements, which the commenter stated that they believe were a result of this single and integrated medical staff model: Core measures in the top quartile with excellent value-based purchasing scores according to CMS; lower in-hospital mortality rates that are statistically significant, that is, 17 percent lower than expected; lower hospital readmission rates that are statistically significant, that is, 15 percent lower than expected; and the second lowest congestive heart failure readmission rate in the nation, according to published CMS data.
Since those rules were published, we have not received any negative feedback on the regulatory changes or any evidence that the use of a unified medical staff model is detrimental to patients and their care. And because the potential benefits to using such a system appear to point to patient safety and quality of care specifically, we began to look at two areas in the CoPs for possible revision along these lines, two areas that we believe have the most direct impact on ensuring and promoting a culture of safety in hospitals—QAPI and infection control. We believe that applying the unified model to a hospital's QAPI program and/or a hospital's infection control program would be a natural progression for a multi-hospital system currently using a system governing body and a unified medical staff. By allowing a system governing body the option of unifying and integrating its various member hospital QAPI programs and/or infection control programs into unified programs incorporating each individual hospital's QAPI program and/or infection control program (and thus applying the greater resources of the system to each hospital's QAPI program and/or infection control program), we believe a system might be able to more efficiently and effectively disseminate innovations, solutions, and best practices for patient care to each of its member hospitals through these respective unified programs. The Health Research and Educational Trust, in partnership with the American Hospital Association in a March 2010 publication entitled, “A Guide to Achieving High Performance in Multi-Hospital Health Systems,” identified specific best practices associated with health systems (
Therefore, we propose to apply this same level of flexibility and regulatory burden reduction to a hospital's QAPI program as an option for system governing bodies that directly control and are legally responsible for two or more separately certified hospitals. As with our allowances for system governing bodies and unified medical staffs noted previously, we believe that system governing bodies that are legally responsible for two or more separately certified hospitals should be given the flexibility to determine which model of a QAPI program works best for their individual member and separately certified hospitals. We also believe that, in addition to the efficiencies that might be gained in the management and administration of QAPI programs through the increased resources of the hospital system, there might also be significant improvements in patient safety and outcomes to be achieved through such resources. Allowing for a unified and integrated QAPI program for its member hospitals would provide a system governing body with the needed flexibility and ease of administration to more readily apply the best practices and innovations learned and developed at one hospital to other hospitals subject to the same system governing body that might be facing the same problem-prone areas of patient care. We believe that by allowing system governing bodies this regulatory option, greater communication between member hospitals would be fostered so that a culture of patient safety and quality care could then be more fully integrated throughout the system. Given this flexibility and opportunity for integration, we believe that member hospitals subject to the same system governing body would replace the approach of each hospital operating within its own “silo,” a still all-too-
We propose a new standard at § 482.21(f), “Unified and integrated QAPI program for multi-hospital systems”. We would allow that for a hospital that is part of a hospital system consisting of two or more separately certified hospitals subject to a system governing body legally responsible for the conduct of each hospital, the system governing body could elect to have a unified and integrated QAPI program for all of its member hospitals after determining that such a decision is in accordance with all applicable State and local laws. The system governing body would be responsible and accountable for ensuring that each of its separately certified hospitals meets all of the requirements of this section. Each separately certified hospital subject to the system governing body would have to demonstrate that: The unified and integrated QAPI program was established in a manner that took into account each member hospital's unique circumstances and any significant differences in patient populations and services offered in each hospital; and the unified and integrated QAPI program establishes and implements policies and procedures to ensure that the needs and concerns of each of its separately certified hospitals, regardless of practice or location, are given due consideration, and that the unified and integrated QAPI program has mechanisms in place to ensure that issues localized to particular hospitals are duly considered and addressed. Our expectation is that the focus on quality assessment, performance improvement, and patient safety within a certified hospital that is part of a unified and integrated QAPI program would be maintained and enhanced through the benefits of such integration.
The current CoP at § 482.22, “Medical Staff,” requires that a hospital have an organized medical staff that operates under bylaws approved by the governing body, and which is responsible for the quality of medical care provided to patients by the hospital. At § 482.22(c)(5), the hospital medical staff bylaws must include a requirement that a H&P be completed and documented for each patient no more than 30 days before or 24 hours after admission or registration, but prior to surgery or a procedure requiring anesthesia services. The bylaws must also include a requirement that an updated examination of the patient, including any changes in the patient's condition, be completed and documented within 24 hours after admission or registration, but prior to surgery or a procedure requiring anesthesia services, when the H&P are completed within 30 days before admission or registration. These medical staff bylaws requirements addressing patient H&Ps form the basis for similar requirements in the hospital CoPs at § 482.24, “Medical Record Services,” and § 482.51, “Surgical Services.”
Current hospital H&P requirements were proposed and finalized between 2005 and 2007, and similar ASC requirements were finalized 1 year later. According to a February 28, 2017, Centers for Disease Control and Prevention (CDC) National Health Statistics Report (Hall MJ, Schwartzman A, Zhang J, Liu X. Ambulatory surgery data from hospitals and ambulatory surgery centers: United States, 2010. National health statistics reports; no. 102. Hyattsville, MD: National Center for Health Statistics. 2017), in 2010, 28.6 million ambulatory surgery visits to hospitals and ASCs occurred, with an estimated 48.3 million surgical and nonsurgical procedures performed. The report also states that an estimated 25.7 million (53 percent) ambulatory surgery procedures were performed in hospitals and 22.5 million (47 percent) were performed in ASCs during this time. Further, the report found that the most frequently performed procedures (for both ASCs and hospital outpatient/ambulatory surgery departments) included endoscopy of large intestine (4.0 million), endoscopy of small intestine (2.2 million), extraction of lens (2.9 million), insertion of prosthetic lens (2.6 million), and injection of agent into spinal canal (2.9 million). These statistics, which also show similarities between the characteristics of patients seen by ASCs and hospital outpatient/ambulatory surgery departments, combined with the evidence already discussed in section II.B.2, “Patient Admission, Assessment and Discharge” (§ 416.52(a)(1), (2), (3) and (4)) have led us to conclude that we should propose a less burdensome option for the assessment of a patient prior to a hospital outpatient/ambulatory surgery or procedure for specific patients and procedures.
Because the hospital H&P requirements apply to all hospital patients (not just ambulatory surgery patients, as in ASCs) and because these requirements are contained under three separate CoPs, any proposed hospital requirements for pre-surgical assessments in lieu of the current requirements for a comprehensive H&P would need to be structured somewhat differently than those proposed for ASCs. However, we are basing certain aspects of the proposed hospital requirements on those proposed for ASCs in order to take into account some of the similarities of the two provider types.
We would revise the current requirements at § 482.22(c)(5)(i) and (ii) with respect to medical staff bylaws to allow for an exception under the proposed paragraph (c)(5)(iii). We are retaining the current language in paragraphs (c)(5)(i) and (ii) that the H&P, and any update to it, must be completed and documented by a physician (as defined in section 1861(r) of the Act), an oromaxillofacial surgeon, or other qualified licensed individual in accordance with State law and hospital policy. We propose to include this same language regarding who can complete and document the assessment in the proposed provision at § 482.22(c)(5)(iii). This provision would require the medical staff bylaws to state that an assessment of the patient (in lieu of the requirements of paragraphs (c)(5)(i) and (ii)) be completed and documented after registration, but prior to surgery or a procedure requiring anesthesia services, when the patient is receiving specific outpatient surgical or procedural services and when the medical staff has chosen to develop and maintain a policy that identifies, in accordance with the requirements at paragraph (c)(5)(v), specific patients as not requiring a comprehensive medical history and physical examination, or any update to it, prior to specific outpatient surgical or procedural services. The proposed paragraphs (c)(5)(iii) and (iv) would require the medical staff to develop and maintain a policy that identifies those patients for whom the assessment requirements of paragraph (c)(5)(iii) would apply. We are also proposing a new requirement at paragraph (c)(5)(v) for a medical staff that chooses to develop and maintain a policy for the identification of specific patients to whom the assessment requirements in paragraph (c)(5)(iii) would apply. Under this proposed paragraph, if the medical staff exercised the option to perform a simplified assessment in some cases, the written policy would have to indicate the specific outpatient surgical or procedural services to which it applied. The policy for each procedure would
In order to make clear that this proposed requirement would be an option that a hospital and its medical staff could elect to use at their discretion, we propose language that states “the provisions of paragraphs (c)(5)(iii), (iv), and (v) do not apply to a medical staff that chooses to maintain a policy that adheres to the requirements of paragraphs (c)(5)(i) and (ii) for all patients.” In other words, a hospital and its medical staff would be free to exercise their clinical judgment in determining whether a policy for identifying specific patients as not requiring a comprehensive H&P (or any update to it) prior to specific outpatient surgical or procedural services, and instead requiring only a pre-surgical assessment for these patients, would be their best course. Or, if a hospital and its medical staff decided against such a policy, then only the current H&P and update requirements (at §§ 482.22, 482.24, and 482.51) would continue to apply and the proposed requirements for this CoP, as well as those proposed for §§ 482.24 and 482.51, would not apply.
For the current CoP at § 482.24, “Medical Record Services,” we would revise the provisions at § 482.24(c)(4)(i)(A) and (B) regarding an H&P and its update to allow for an exception under proposed paragraph (c)(4)(i)(C) where are proposing to add a new requirement that, if applicable, the medical record would have to document assessment of the patient (in lieu of the requirements of paragraphs (c)(4)(i)(A) and (B) after registration, but prior to surgery or a procedure requiring anesthesia services, for specific outpatient surgical or procedural services.
The current CoP at § 482.51, “Surgical Services,” contains provisions at § 482.51(b)(1)(i) and (ii) that require, prior to surgery or a procedure requiring anesthesia services and except in the case of emergencies that a medical history and physical examination must be completed and documented no more than 30 days before or 24 hours after admission or registration an updated examination of the patient, including any changes in the patient's condition, must be completed and documented within 24 hours after admission or registration when the medical history and physical examination are completed within 30 days before admission or registration. We are revising these requirements to allow for an exception to them under proposed paragraph (b)(1)(iii), where we propose a new requirement that, prior to surgery or a procedure requiring anesthesia services and except in the case of emergencies, an assessment of the patient must be completed and documented after registration (and in lieu of the requirements of paragraphs (b)(1)(i) and (ii)). This proposed requirement would only apply in those instances when the patient is receiving specific outpatient surgical or procedural services and when the medical staff has chosen to develop and maintain a policy that identifies, in accordance with the requirements at § 482.22(c)(5)(v), specific patients as not requiring a comprehensive medical history and physical examination, or any update to it, prior to specific outpatient surgical or procedural services.
As we did in the ASC section's discussion of these proposed changes to the H&P requirements, we request comment on whether there are any evidence-based exceptions or specific guidelines, such as for particular patient conditions or surgical procedures, that would prohibit this level of discretion for determining those hospital outpatient surgery patients who would not require a comprehensive H&P prior to outpatient surgeries or procedures.
In the June 1986 final rule, Medicare and Medicaid Programs, Conditions of Participation for Hospitals (51 FR 22010), we finalized a regulation to recommend that a hospital's medical staff attempt to secure autopsies in all cases of unusual deaths and of medical-legal and educational interest. Hospitals are further required to define a mechanism for documenting permission to perform an autopsy, and they must have a system for notifying the medical staff, and specifically the attending practitioner, when an autopsy is being performed. In that final rule, we stated that autopsies were an essential educational tool which contributed to the quality of care furnished by a hospital. Medical-legal investigative autopsies are conducted by a coroner's or medical examiner's office to determine the circumstances under which someone died and combine a scientific inquiry into a death under a coroner's or medical examiner's legal jurisdiction (
Although the regulations specify that hospitals should attempt to secure permission to perform autopsies in certain cases, each state has established specific standards, laws, and regulations regarding the performance of autopsies for medical-legal investigative purposes for hospital patients. According to CDC's Public Health Law Program, each State sets its own standards for what kinds of deaths require investigation and its own professional and continuing education requirements for individuals carrying out these investigations. For example, the Medicolegal Death Investigation system for the state of New York specifies the use of coroners and medical examiners, who have specific medical and residency qualifications. Maine's Medicolegal Death Investigation system only specifies the role of a medical examiner. Unlike the regulations of the individual States, § 482.22(d) does not provide specifics on who should perform an autopsy, nor does it delve into the specifics of the medical-legal investigation process. As with all other CoPs, our intention was not to be overly prescriptive or overly burdensome in our requirements. In this case, the individual States have more specific requirements than the CoPs.
After reexamining this CoP, and in an effort to reduce duplicative or redundant requirements for hospitals, we believe that it is appropriate to remove the requirement at § 482.22(d). We believe that more detailed, specific requirements regarding medical-legal investigations and autopsies for hospitals are more appropriately and more effectively covered by the individual State laws in which the hospital is located. Therefore, we propose to remove the requirement at § 482.22(d). However, we continue to believe that the performance of autopsies further advances medical knowledge.
Similar to our proposal for a unified and integrated QAPI program for multi-hospital systems previously discussed, we believe that the same level of flexibility and regulatory burden reduction can be applied to a hospital's infection control program. We firmly believe that the same efficiency of administration, and improved patient outcomes, patient safety, and quality of care would be achieved in the infection control realm through a consistent system-wide approach as would be
Therefore, we propose a new standard at § 482.42(c), “Unified and integrated infection control program for multi-hospital systems.” Like the proposed requirements for a unified and integrated QAPI program, the proposed standard for infection control would allow that for a hospital that is part of a hospital system consisting of multiple separately certified hospitals subject to a system governing body legally responsible for the conduct of each hospital, such system governing body could elect to have a unified and integrated infection control program for all of its member hospitals after determining that such a decision was in accordance with all applicable State and local laws. The system governing body would be responsible and accountable for ensuring that each of its separately certified hospitals met all of the requirements of this section. Each separately certified hospital subject to the system governing body would have to demonstrate that the unified and integrated infection control program: (1) Was established in a manner that took into account each member hospital's unique circumstances and any significant differences in patient populations and services offered in each hospital; (2) established and implemented policies and procedures to ensure that the needs and concerns of each of its separately certified hospitals, regardless of practice or location, are given due consideration; (3) had mechanisms in place to ensure that issues localized to particular hospitals are duly considered and addressed; and (4) designated a qualified individual(s) at the hospital with expertise in infection prevention and control to be responsible for communicating with the unified infection control program, for implementing and maintaining the policies and procedures governing infection control, and for providing infection prevention education and training to hospital staff.
We are specifically seeking comment on whether there are any other programs currently required under the CoPs for each separately certified hospital, beyond the QAPI and Infection control programs proposed here, that stakeholders believe would likewise be better managed under a system governing body legally responsible for the conduct of each separately certified hospital.
Section 1883 of the Act permits certain small, rural hospitals to enter into a swing-bed agreement, under which a hospital or CAH can use its beds as needed, to provide either acute or SNF care. Swing-beds are beneficial when a patient is ready to leave the acute care level of a hospital stay, but still requires further skilled nursing care. They are often the only option in rural areas to provide this level of care. As defined in our regulations, a swing-bed hospital is a hospital or CAH participating in Medicare that has CMS approval to provide post-hospital SNF care and meets certain requirements. Hospitals providing swing-bed services must meet all of the requirements at 42 CFR part 482, which includes the swing-bed requirements at § 482.58 for patients receiving swing-bed services, and CAHs providing swing-bed services must meet all of the requirements at 42 CFR part 485, subpart F, which includes the swing-bed requirements at § 485.645 for patients receiving swing-bed services.
The hospital CoPs at § 482.58(a)(1) and (2) specify that hospitals providing swing-bed services must be located in a rural area and have less than 100 beds. Section 482.58(a)(1) excludes from the count beds for newborns and beds in intensive care type inpatient units, and § 482.58(a)(2) requires that the hospital be located in rural area, which includes all areas not delineated as “urbanized” areas by the Census Bureau, based on the most recent census.
The CAH CoPs at § 485.645(a)(2) state that a CAH must not maintain more than 25 inpatient beds that may be used for the provision of inpatient or swing-bed services, and as required at § 485.635(b)(1)(ii), the CAH must furnish acute care inpatient services to patients who present to the CAH for treatment, so long as the CAH has an available inpatient bed and the treatment required to appropriately care for the patient is within the scope of services offered by the CAH (State Operations Manual, Appendix W).
Hospitals and CAHs must both meet eligibility requirements to be granted approval from CMS to provide swing-bed services. The swing-bed requirements within the hospital and CAH CoPs include a subset of cross-referenced long-term care requirements contained in 42 CFR part 483, subpart B, for which hospital and CAH swing-bed providers are surveyed as they are for all of the CoPs in their respective programs.
The long-term care requirements under 42 CFR part 483 frequently reference residents given the average length of stay in long-term care facilities (28 days for skilled nursing facilities and 835 days for nursing homes) (Medicare Skilled Nursing Facility (SNF) Transparency Data (CY2013),
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The current requirement for LTCFs also states that residents of these providers who are receiving swing-bed services who choose to perform services for the facility may do so when the facility has documented the need or desire for the resident to work in the plan of care; the plan specifies the nature of the services performed and whether the services are voluntary or paid; compensation for paid services is
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Similar to the requirements noted previously, we believe that this requirement is also unnecessary and burdensome for hospitals and CAHs, as patients receiving swing-bed services in a hospital or CAH are not long term residents of the facility and generally only receive swing-bed services for a brief period of time for transition after the provision of acute care services. We expect that for those patients who receive swing-bed services for an extended period of time, their nursing care plan—as required under § 482.23(b)(4) for hospitals and § 485.635(d)(4) for CAHs—is based on assessing the patient's nursing care needs and will support care that holistically meets the needs of the patient, taking into consideration physiological and psychosocial factors.
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We propose to revise the requirements at §§ 482.58(b)(5) and 485.645(d)(5) for hospitals and CAHs. The requirement that hospital and CAH swing-bed providers with more than 120 beds employ a full-time social worker is not applicable to either provider type. In accordance with the hospital and CAH swing-bed requirements, hospital swing-bed providers are not permitted to have more than 100 beds while CAH swing-bed providers are not permitted to have more than 25 beds for the provision of inpatient or swing-bed services. Based on feedback from stakeholders, removing this requirement would eliminate confusion for providers and accreditation organizations.
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Section 482.61(d) of our regulations, as finalized in the June 1986 final rule (51 FR 22050), requires that progress notes be documented by the doctor of medicine (MD) or doctor of osteopathy (DO) responsible for the care of the patient and, when appropriate, others significantly involved in active treatment modalities. “Others significantly involved in active treatment modalities” has been interpreted as staff from other disciplines, such as rehabilitative therapy and psychology, which are significantly involved in active treatment modalities and interventions. The intent of this requirement is to assure that the patient's medical record contains documentation of the patient's response to treatment planning and course of treatment. This documentation also serves to apprise all staff about patient's progress and any new problems or regression. We believe that the intent of the requirement to record progress notes in the patient's medical record continues to be an appropriate regulatory requirement. However, we
We are seeking public comment on all of the proposed hospital changes. In addition, we note that we seek to reduce burdens for health care providers and patients, improve the quality of care, decrease costs, and ensure that patients and their providers and physicians are making the best health care choices possible. Therefore, we are soliciting public comments on additional regulatory reforms for burden reduction in future rulemaking. Specifically, we are seeking public comment on additional proposals or modifications to the proposals set forth in this rule that would further reduce burden on hospitals and create cost savings, while also preserving quality of care and patient health and safety. Consistent with our “Patients Over Paperwork Initiative,” we are particularly interested in any suggestions to improve existing requirements, within our statutory authority, where they make providing quality care difficult or less effective. We also note that such suggestions could include or expand upon comments submitted in response to RFIs that were included in the following 2017 prospective payment regulations for hospitals:
• FY 2018 Hospital Inpatient Prospective Payment System for Acute Care Hospitals and the Long-Term Care Hospital Prospective Payment System found at
• CY 2018 Outpatient Prospective Payment System/Ambulatory Surgical Center proposed rule (
• FY 2018 Inpatient Rehabilitation Facility Prospective Payment System (
• FY 2018 Inpatient Psychiatric Facilities Prospective Payment System (
Public comments on the RFIs can be found by searching for the terms “RFI” or “request for information” in the aforementioned 2017 payment regulation dockets on
The most useful comments will be those that include data or evidence to support the position, offer suggestions to amend specific sections of the existing regulations, or offer particular additions.
Transplant programs, located within a transplant hospital that has a Medicare provider agreement, provide transplantation services for a particular organ type. Transplant programs must comply with the transplant center CoPs, located at §§ 482.72 through 482.104, and with the hospital CoPs. There are several types of transplant programs including heart, lung, liver, and kidney. Intestine, pancreas, and multi-organ transplants are performed within existing transplant programs. For the purposes of this discussion, we define a transplant center as a group of transplant programs that are located in a transplant hospital. A transplant program is a component of the transplant center, within a transplant hospital, that provides transplantation for a particular type of organ. Transplant programs are surveyed for compliance with the CoPs.
This proposed rule uses the term “transplant center” when discussing the current requirements and language used in the regulations. In accordance with our proposed nomenclature change, discussed later in this proposed rule, the term “transplant program” is widely used throughout the preamble and in the proposed regulation text.
Section 1881(b)(1) of the Act sets out our authority for the Secretary to prescribe regulations for facilities furnishing end stage renal disease care to beneficiaries, including renal transplant centers. Section 1861(e)(9) of the Act permits the Secretary to issue regulations for the health and safety of individuals furnished services in hospitals.
In response to the relative scarcity of donated organs compared to the number of people on transplant waitlists and the critical need to use these limited resources efficiently, we published a final rule that established CoPs for transplant centers on March 30, 2007, (Medicare Program; Hospital Conditions of Participation: Requirements for Approval and Re-Approval of Transplant Centers To Perform Organ Transplants) which codified requirements for approval and re-approval of transplant centers. We also placed Medicare-approved transplant centers under the survey and certification enforcement process we use for all other providers and suppliers of Medicare items and services (72 FR 15198). The transplant center CoPs include data submission, clinical experience, outcome, and process requirements for approval and re-approval of transplant centers. The requirements focus on an organ transplant program's ability to perform successful transplants and deliver quality patient care, as evidenced by outcomes as well as sound policies and procedures. The CoPs include requirements to protect the health and safety of both transplant recipients and living donors.
We have continued to review and analyze the effectiveness of the transplant center CoPs, the effects of interpretive guidance, and the data derived from surveys of transplant programs. We also received comments from various stakeholders within the transplant center community that detailed the impacts of the implementation of the CoPs on transplant programs and transplant recipients. Upon further review, and taking into account input from various stakeholders, we believe that it is appropriate and necessary to revise the transplant center CoPs in order to reduce provider burden, increase long-term savings to the Medicare program, and eliminate obsolete or unnecessary requirements, while also continuing to protect the health and safety of transplant recipients and living donors.
Furthermore, we believe that revising the transplant center CoPs will positively impact organ donation and transplantation in the United States by increasing the number of transplants performed each year and increasing the organ utilization rate, for reasons we discuss in further detail below. According to the Organ Procurement and Transplantation Network (OPTN) 33,610, organ transplants were performed and 15,948 donors (both living and deceased) provided organs in the United States in 2016. However, as of the writing of this proposed rule, 117,104 people still need a lifesaving organ transplant in 2017 (number represents total waiting list candidates,
Therefore, we propose to revise the transplant center CoPs, as follows:
Section 482.68 generally describes the requirements that a transplant center must meet in order to participate in the Medicare program; section § 482.70 sets out definitions of terms used in the regulations. Specifically, in addition to meeting all the CoPs as a hospital, a transplant center must meet the CoPs specified in §§ 482.72 through 482.104 in order to be granted approval from CMS to provide transplant services. Throughout the regulation, we use terminology relevant to transplantation and organ procurement to describe transplant centers, programs, living donors, and transplant center recipients. Because the terminology currently used in the regulation is not consistent with current nomenclature used throughout the transplant community and by the OPTN, Scientific Registry of Transplant Recipients (SRTR), and the Department of Health and Human Services (HHS), we propose to update the terminology within the hospital regulation at part 482 and the transplant regulations at §§ 482.68, 482.70, 482.72 through 482.104, and at § 488.61, for clarification and consistency. Specifically, we propose a nomenclature change which would:
• Replace the term transplant “center” in the regulation language with transplant “program” (each organ type would be a transplant program). A transplant program is located within a transplant hospital that provides transplantation services for a particular type of organ. Since individual transplant programs are surveyed for compliance with the CoPs, using the term transplant program throughout the regulation better aligns with current surveyor practice and will reduce provider confusion. In order to provide further clarity, we are also proposing to update the definitions at § 482.70.
• Consistently use Independent Living Donor Advocate (ILDA) throughout the regulation.
• Change “beneficiaries” to “recipients”.
Since these changes would make our terms consistent with the terminology utilized by the OPTN and the transplant community, we believe these proposed changes would reduce provider confusion.
Section 482.82 requires that transplant centers that are applying for Medicare re-approval meet all data submission, clinical experience, and outcome requirements in order to be re-approved. In the March 2007 final rule (72 FR 15198), we also finalized these requirements for initial Medicare approval of transplant centers, as described in § 482.80. Since the publication of the final rule, several studies have been published that examine the impact of these requirements on transplantation and organ utilization in the United States. A 2016 article published in the American Medical Association Journal of Ethics concluded that “using measured outcomes for punitive purposes may have resulted in significant unintended consequences” and that “transplant professionals will, by necessity, adapt practice to minimize the risk of regulatory citation and loss of transplant volume” which contributes to “lower transplant rates (typically among higher-risk candidates)” and increased organ discard of marginal organs. (Adler, Joel T. and Axelrod, David A. Regulations' Impact on Donor and Recipient Selection for Liver Transplantation: How Should Outcomes be Measured and MELD Exception Scores be Considered, AMA Journal of Ethics, Vol. Volume 18, Number 2: 133-142. Doi: 10.1001/journalofethics.2016.18.02.pfor1-1602, February 2016.).
Another study linked performance evaluations to transplant volume in kidney transplant centers. The authors observed that centers that had low performance evaluations were more likely to have fewer kidney transplants than other kidney transplant centers. The study stated that kidney transplant centers that were identified with poor outcomes “may be more likely to have staff turnover which may lead to declines in transplant volume” and “[c]enters that have been evaluated with lower performance may generally become more conservative in overall acceptance rates of candidates and donor organs” (Schold, JD, et al. The Association of Center Performance Evaluations and Kidney Transplant Volume in the United States.
Another study covering over 90,000 liver transplant candidates concluded that the transplant center regulations that were finalized in the March 2007 final rule (72 FR 15198) increased the likelihood that liver transplant candidates would be removed from the liver transplant candidate waitlist and that this policy change led to the sickest patients being increasingly “denied this lifesaving procedure while transplant mortality risks remain unaffected.” The study found that the 2007 regulations had the effect of altering waitlist management and clinical decision making, thereby increasing the removal of the sickest patients from the waitlist. The impacts were seen through a 16 percent increase in delisting of patients due to the severity of their illness after the implementation of the 2007 regulation, and likelihood of being delisted continued to increase thereafter. The authors concluded that the 2007 regulation, which aimed to improve patient outcomes, had the consequence of instead failing to show any benefit to liver transplant patients. The authors suggested that future national policy decisions consider rebalance of the waitlist and transplant outcomes scale (Dolgin, Natasha H. et al. Decade-Long Trends in Liver Transplant Waitlist Removal Due to Illness Severity: The Impact of Centers for Medicare and Medicaid Services Policy. Journal of the American College of Surgeons. Volume 222, Issue 6, Pages 1054-1065. DOI:
Another study of kidney transplantation found that most of the increases in the discard rate from 1988 to 2009 could be explained by recovery of organs from an increasing donor pool and changes in “pumping” or perfusion practices. “However, the presence of an unexplained, residual increase suggests behavioral factors (
A different approach was taken in a recent study using data from 2000 to 2015. This study found that by comparing donors from whom one only one kidney was discarded and the other was transplanted reasons for discard could be better assessed. In this study “a large number of discarded kidneys were procured from donors whose contralateral kidneys were transplanted with good post-transplant outcomes.” It found that when two kidneys were retrieved from a deceased donor, and one of the two was discarded and the other used in a transplant, it was often the case that these “discarded organs could have possibly demonstrated excellent performance if transplanted” and “the use of even a fraction of them could substantially reduce the number of patients who never receive an organ.” As for the cause of these discards, the authors analyzed several factors and stated that “the current report card system for transplant centers in the
We also received comments and feedback from pertinent stakeholders in the transplant community that align with the conclusions of these studies. For instance, UNOS has presented at public meetings that up to
While it was our intent to ensure quality of care in transplant programs with the implementation of the regulations in § 482.82, we acknowledge that the final regulation may have caused unintended consequences that impact transplantation and transplant programs in the U.S. Given the findings of published studies and articles, and the public feedback we have received, we believe that it is appropriate to remove these requirements for re-approval of transplant programs in the Medicare program.
Therefore, we propose to remove the requirements at § 482.82 that require transplant centers to submit data (including, but not limited to, submission of the appropriate OPTN forms for transplant candidate registration, transplant beneficiary registration and follow-up, and living donor registration and follow-up), clinical experience, and outcome requirements for Medicare re-approval, and make conforming changes to § 482.102(a)(5) “Condition of participation, Patient and living donor rights” and § 488.61 “Special Procedures for Approval and Re-Approval of Organ Transplant Centers.” Although we propose to remove these requirements, we continue to strongly believe that transplant programs should focus on maintaining high standards that protect patient health and safety and produce positive outcomes for transplant recipients. Therefore, we will continue to monitor and assess outcomes, after initial Medicare approval, through the transplant and hospital QAPI programs. In addition, quality of care will be monitored by assessing the other transplant program CoPs, including §§ 482.72 through 482.104. We also encourage transplant programs and their respective hospitals' QAPI programs to conduct thorough analyses of adverse events, document such events, and implement improvement activities to prevent recurrences. We further note that transplant programs must continue to comply with the CoPs at §§ 482.72 through 482.104 and the data submission, clinical experience, and outcome requirements for initial Medicare approval under § 482.80. We believe this proposal will eliminate provider disincentives for performing transplantations and will lead to increased transplantation opportunities for patients on the waitlist; improved organ procurement for transplantation; greater organ utilization; lifesaving effects, reduced burden on transplant programs; and reductions in costs to both public and private insurance.
We are seeking public comment on the removal of this requirement.
Section 488.61 describes the survey, certification, and enforcement procedures for transplant centers, including the periodic review of compliance and approval as set out at § 488.20. Section 488.61(f) through (h) set out the process for our consideration of a transplant center's mitigating factors in initial approval and re-approval surveys, certifications, and enforcement actions for transplant centers. The provisions also set out definitions and rules for transplant systems improvement agreements. We propose to remove the requirements at § 488.61(f) through (h) for mitigating factors and transplant systems improvement agreements for the re-approval process for transplant centers. This change is complementary to the proposed removal of § 482.82, described previously. We believe that repeal of these paragraphs would significantly reduce transplant programs' regulatory burden by no longer requiring them to submit mitigating factors applications or enter into systems improvement agreements for outcomes non-compliance (for re-approval surveys, certifications, and enforcement actions for transplant programs). Transplant programs will continue to be afforded the opportunity to submit mitigating factors or to enter into transplant systems improvement agreements during the initial application process to the Medicare program under § 488.61 (f) through (h).
We seek to reduce burdens for health care providers and patients, improve the quality of care, decrease costs, and ensure that patients and their providers and physicians are making the best health care choices possible. Therefore, we are soliciting public comments on additional regulatory reforms for burden reduction in future rulemaking. Specifically, we are seeking public comment on additional proposals or modifications to the proposals set forth in this rule that would further reduce burden on transplant programs and create cost savings, while also preserving quality of care and patient health and safety. Consistent with our “Patients Over Paperwork Initiative,” we are particularly interested in any suggestions to improve existing requirements, within our statutory authority, where they make providing quality care difficult or less effective. We also note that such suggestions could include or expand upon comments submitted in response to the RFI that was included in the FY 2018 Hospital Inpatient Prospective Payment System for Acute Care Hospitals and the Long-Term Care Hospital Prospective Payment System proposed rule. Public comments in response to this RFI can be found at the following link:
The most useful comments will be those that include data or evidence to support the position, offer suggestions to amend specific sections of the existing regulations, or offer particular additions.
Home health services are covered for the elderly and disabled under the
• Part-time or intermittent skilled nursing care furnished by or under the supervision of a registered professional nurse.
• Physical therapy, speech-language pathology, and occupational therapy.
• Medical social services under the direction of a physician.
• Part-time or intermittent home health aide services.
• Medical supplies (other than drugs and biologicals) and durable medical equipment.
• Services of interns and residents if the HHA is owned by or affiliated with a hospital that has an approved medical residency training program.
• Services at hospitals, skilled nursing facilities, or rehabilitation centers when the services involve equipment too cumbersome to bring to the home.
Under the authority of sections 1861(o) and 1891 of the Act, the Secretary has established in regulations the requirements that an HHA must meet to participate in the Medicare program. These requirements are set forth in regulations at 42 CFR part 484, Home Health Services.
Section 484.50(a)(3) of the January 2017 HHA CoP final rule (82 FR 4504), effective January 13, 2018, requires HHAs to provide verbal (meaning spoken) notice of the patient's rights and responsibilities in addition to the requirement to provide such notice in writing. Section 1891(a)(1)(E) of the Act requires additional oral notice of rights for specified information as follows:
• All items and services furnished by (or under arrangements with) the agency for which payment may be made under Medicare,
• The coverage available for such items and services under Medicare, Medicaid, and any other Federal program of which the agency is reasonably aware,
• Any charges for items and services not covered under Medicare and any charges the individual may have to pay with respect to items and services furnished by (or under arrangements with) the agency, and
• Any changes to the charges or items and services set forth in the previous bullets.
Section 1891(a)(1)(F) of the Act requires that HHAs provide the notice of patient rights in writing.
The requirements at § 484.50(a)(3) implement these statutory requirements, and require spoken notice of all patient rights, rather than limiting such notice to those rights specified in the Act. On July 28, 2017, we published a proposed rule entitled “CY 2018 Home Health Prospective Payment System Rate Update; Home Health Value Based Purchasing Model; and Home Health Quality Reporting Requirements” (82 FR 35270) that solicited public comments on ways to reduce regulatory burden. In response to this solicitation, we received feedback from HHA stakeholders that the requirement to provide verbal notice of all rights to patients and their representatives was overly burdensome to the HHA clinicians that would be required to discuss the notice with patients when they could be furnishing hands-on patient care during that time, and lacked evidence that such explanations would result in improvements to patient safety or care. Furthermore, comments received encouraged us to reexamine all burdens in the January 2017 HHA CoP final rule to weigh potential benefits against estimated costs.
We believe that the concerns expressed by commenters have merit. In light of this information, we believe that any benefits of this requirement are outweighed by the burdens imposed by this requirement. For this reason, we propose to delete the requirement that HHAs must provide verbal notification of all patient rights. This change would be consistent with the notice of patient rights requirements for other outpatient provider types, such as hospices, ambulatory surgery centers, and community mental health centers, for which written notice of patient rights is the only requirement. We propose to limit the verbal notification requirements to those requirements set out in section 1891(a)(1)(E) of the Act for which verbal notification is mandatory. We propose to revise § 484.50(c)(7) to implement this more limited verbal notification requirement. Revised § 484.50(c)(7) would require HHAs to verbally discuss HHA payment and patient financial liability information with each HHA patient as described above.
This change would not prevent states or Accrediting Organizations (AOs) from independently establishing and enforcing verbal notification requirements for all patient rights for purposes other than the HHA CoPs, nor would it prohibit HHAs from providing such verbal notification of all patient rights in the absence of Federal regulation. Furthermore, this change would not alter the other requirements at § 484.50(a), which requires HHAs to provide the notice of patient rights in writing, nor would it alter the requirements at § 484.50(f), Accessibility, which requires HHAs to provide information to patients in plain language and in a manner that is both accessible and timely to: (1) Persons with disabilities in accordance with the Americans with Disabilities Act and Section 504 of the Rehabilitation Act, and (2) persons with limited English proficiency. While HHAs would no longer be required to provide a verbal notification of all patient rights, we would continue to expect that HHAs answer any questions from patients or their representatives regarding the content of the written notice of rights. We believe that this proposed change would continue to provide adequate notice to patients while reducing burden on HHAs.
Section 484.80(h)(3) of the January 2017 HHA CoP final rule (82 FR 4504) requires that, when a supervisory visit identifies a deficiency in a home health aide's skills, the HHA must conduct, and the aide must complete, a full competency evaluation to assess all aide skills and identify any other skill deficiencies that were not identified while observing the aide performing care with a patient. In public comments submitted for the July 2017 proposed rule “CY 2018 Home Health Prospective Payment System Rate Update” (82 FR 35270), a commenter suggested that completing a full competency evaluation was overly burdensome for HHAs and aides. Although this comment was not submitted during the proposed rule public comment period for the HHA CoP proposed rule, we believe that the concern expressed by the commenter has merit. In light of this new comment, we reconsidered the requirement, and concluded that a full competency evaluation is unnecessary and overly burdensome when only certain skills have been identified as deficient. We propose to eliminate the requirement to conduct a full competency evaluation, and replace it with a requirement to retrain the aide regarding the identified deficient skill(s) and require the aide to complete a
In the January 2017 HHA CoPs final rule (82 FR 4504), effective January 13,
We seek to reduce burdens for health care providers and patients, improve the quality of care, decrease costs, and ensure that patients and their providers and physicians are making the best health care choices possible. Therefore, we are soliciting public comments on additional regulatory reforms for burden reduction. Specifically, we are seeking public comment on additional proposals or modifications to the proposals set forth in this rule that would further reduce burden on HHAs and create cost savings, while also preserving quality of care and patient health and safety. Consistent with our “Patients Over Paperwork Initiative,” we are particularly interested in any suggestions to improve existing requirements, within our statutory authority, where they make providing quality care difficult or less effective.
We also note that such suggestions could include or expand upon comments submitted in response to the RFI that was included in the CY 2018 Home Health Prospective Payment System Rate Update; Value-Based Purchasing Model; and Quality Reporting Requirements. Public comments in response to this RFI can be found at the following link:
The most useful comments will be those that include data or evidence to support the position, offer suggestions to amend specific sections of the existing regulations, or offer particular additions.
Section 485.51 of our rules defines a Comprehensive Outpatient Rehabilitation Facility (CORF) as a nonresidential facility that is established and operated exclusively for the purpose of providing diagnostic, therapeutic, and restorative services to outpatients for the rehabilitation of injured, disabled, or sick persons, at a single fixed location, by or under the supervision of a physician. As of May 2017, there were 188 Medicare-certified CORFs in the United States. Section 1861(cc)(2)(G) of the Act requires CORFs to maintain utilization review programs. Under this authority, the Secretary has established requirements at § 485.66 with respect to such programs. Currently, § 485.66 requires the CORF to have in effect a written utilization review plan that is implemented at least each quarter, to assess the necessity of services and promotes the most efficient use of services provided by the facility.
We propose to amend the utilization review plan requirements at § 485.66 to reduce the frequency of utilization reviews. We believe the requirement to implement a utilization review plan 4 times a year is overly burdensome and diverts staff from providing patient care. We propose to require the utilization review plan be implemented annually by the facility, which would allow an entire year to collect and analyze data to inform changes to the facility and the services provided. Changing the requirement from a quarterly to an annual review would not preclude the CORF from implementing their utilization review plan more frequently, if required by facility policy. We believe that an annual utilization review plan will serve as a useful measurement tool for the facility, and that the change from quarterly to annual would not negatively affect patient health and safety.
We seek to reduce burdens for health care providers and patients, improve the quality of care, decrease costs, and ensure that patients and their providers and physicians are making the best health care choices possible. Therefore, we are soliciting public comments on additional regulatory reforms for burden reduction in future rulemaking. Specifically, we are seeking public comment on additional proposals or modifications to the proposals set forth in this rule that would further reduce burden on CORFs and create cost savings, while also preserving quality of care and patient health and safety. Consistent with our “Patients Over Paperwork” Initiative, we are particularly interested in any suggestions to improve existing requirements, within our statutory authority, where they make providing quality care difficult or less effective. We also note that such suggestions could include or expand upon comments submitted in response to RFIs that were included in the 2017 payment regulations. We refer readers to the public comments that were submitted in response to the RFI for the following 2017 payment regulations:
• End-Stage Renal Disease Prospective Payment System and Payment for Renal Dialysis Services Furnished to Individuals with Acute Kidney Injury, and End-Stage Renal Disease Quality Incentive Program found at
• CY 2018 Home Health Prospective Payment System Rate Update; Value-Based Purchasing Model; and Quality Reporting Requirements found at
• FY 2018 Hospice Wage Index and Payment Rate Update and Hospice Quality found at
• FY 2018 Hospital Inpatient Prospective Payment System for Acute Care Hospitals and the Long-Term Care Hospital Prospective Payment System RFI, found at
• CY 2018 Hospital Outpatient PPS Policy Changes and Payment Rates and Ambulatory Surgical Center Payment System Policy Changes and Payment Rates found at
• FY 2018 Inpatient Rehabilitation Facility Prospective Payment System found at
• FY 2018 Inpatient Psychiatric Facilities Prospective Payment System found at
• CY 2018 Revisions to Payment Policies under the Physician Fee Schedule and Other Revisions to Part B found at
• FY 2018 Prospective Payment System and Consolidated Billing for Skilled Nursing Facilities found at
Public comments on the RFIs can be found by searching for the terms “RFI” or “request for information” in the aforementioned 2017 payment regulation dockets on
The most useful comments will be those that include data or evidence to support the position, offer suggestions to amend specific sections of the existing regulations, or offer particular additions.
Current regulations at § 485.627 require CAHs to disclose the names and addresses of its owners, those with a controlling interest in the CAH or in any subcontractor in which the CAH directly or indirectly has a 5 percent or more ownership interest, in accordance with 42 CFR part 420, subpart C. Section 42 CFR part 420, subpart C, sets forth requirements for providers, Part B suppliers, intermediaries, and carriers to disclose ownership and control information and sets forth requirements for disclosure of information about a provider's or Part B supplier's owners and those with a controlling interest.
The disclosure of ownership provisions at 42 CFR part 420, subpart C, are also required under the provider agreement rules under 42 CFR part 489. The term “provider agreement” is defined in § 489.3 as an agreement between CMS and a provider or supplier to provide services to Medicare beneficiaries and to comply with the requirements of section 1866 of the Act (Agreements with Providers of Services; Enrollment Processes). Providers must meet the terms of the agreement to be qualified to participate in the Medicare program.
We propose to remove this disclosure requirement from the CAH CoPs as it is duplicative of requirements for the provider agreement. Specifically, disclosure of individuals with a financial interest in the CAH is a requirement under the provider agreement rules in § 489.12(a)(2) and must be completed during the provider enrollment process. This information must be disclosed on the provider's Medicare enrollment application (Form CMS-855A for CAHs) and the enrollment application must be updated with any changes, such as address changes, practice name or change of ownership of information and must be submitted to CMS. Also note that this is not a requirement in the hospital CoPs under 42 CFR part 482 because it is already a requirement in the provider agreement rules under § 498.12(a)(2).
Current regulations at § 485.635 require CAHs to review policies and procedures annually. We believe that medical practice has evolved such that we can provide flexibility for facilities to review, correct, or change their policies and procedures. Based on our experience with medical care providers and information from organizations such as the Brookings Institution (
The current CoP at § 485.635(a)(4) requires a CAH to review its policies at least annually by the CAH's professional healthcare staff, including one or more doctors of medicine or osteopathy and one or more physician assistants, nurse practitioners, or clinical nurse specialists, if they are on staff under the provisions of § 485.631(a)(1). The policies that are reviewed must include the following:
• A description of the services the CAH furnishes, including those furnished through agreement or arrangement;
• Policies and procedures for emergency medical services;
• Guidelines for the medical management of health problems that include the conditions requiring medical consultation and/or patient referral, the maintenance of health care records;
• Rules for the storage, handling, dispensation, and administration of drugs and biologicals;
• Procedures for reporting adverse drug reactions and errors in the administration of drugs; and
• A system for identifying, reporting, investigating and controlling infections and communicable diseases of patients and personnel.
• Procedures that ensure that the nutritional needs of post-hospital SNF inpatients are met in accordance with recognized dietary practices.
Based on feedback from stakeholders, the prescriptive annual schedule can be burdensome or, in some situations, ineffective. Providers stated that they make annual, monthly and biannual changes to their policies. Some have stated that they make changes as needed or infrequently. They also stated that the time that it took to review the policies varied. Some stated it would take as little as 2 hours while a few stated a much longer period time such as a month, depending on what was being changed. We believe that taking a month would represent a new facility or a facility that is experiencing major restructuring. After a careful review of the varied responses, we propose to provide flexibility and reduce burden by revising the requirement at § 485.635(a)(4) to, at a minimum, only require a biennial review of policies and procedures. The 2-year review would not preclude a facility from conducting a review more frequently if needed or organizing the review such that it would be completed over a 2-year period. Based on our experience with other providers, we believe that this approach would allow CAHs to maintain their health and safety policies in such a manner as to achieve the intended outcomes for all patients. Thus, we propose to change the requirement at § 485.635(a)(4) from “annual” to “biennial”.
The special requirements for CAH swing-bed providers are nearly identical to the requirements for hospital providers of swing-bed services. As a result, please refer to the discussion on the special requirements for hospital providers of swing-bed services under section II.D.3 for the details of the proposed changes for these requirements. We propose the following revisions to the CAH swing-bed requirements:
• Revision of § 485.645(d)(1) to remove the cross-referenced long-term care requirement in § 483.10(f)(9), which requires that CAH swing-bed providers to offer residents the right to choose to or refuse to perform services for the facility and prohibits a facility from requiring a resident to perform services for the facility;
• Removal of § 485.645(d)(4), which requires CAH swing-bed providers to provide an ongoing activity program that is directed by a qualified therapeutic recreation specialist or an activities professional who meets certain requirements (cross-referenced long-term care requirement § 483.24(c));
• Redesignation of paragraphs (d)(5) through (9) as (d)(4) through (8), respectively;
• Revision of § 485.645(d)(4) (as redesignated) to remove the cross-referenced long-term care requirement § 483.70(p), which requires that CAH swing-bed providers with more than 120 beds to employ a qualified social worker on a full-time basis; and
• Revision of § 485.645(d)(7) (as redesignated) to remove the cross-referenced long-term care requirement § 483.55(a)(1), which requires CAH swing-bed providers to assist in obtaining routine and 24-hour emergency dental care to its residents.
We seek to reduce burdens for health care providers and patients, improve the quality of care, decrease costs, and ensure that patients and their providers and physicians are making the best health care choices possible. Therefore, we are soliciting public comments on additional regulatory reforms for burden reduction in future rulemaking. Specifically, we are seeking public comment on additional proposals or modifications to the proposals set forth in this rule that would further reduce burden on CAHs and create cost savings, while also preserving quality of care and patient health and safety. Consistent with our “Patients Over Paperwork” Initiative” we are particularly interested in any suggestions to improve existing requirements, within our statutory authority, where they make providing quality care difficult or less effective. We also note that such suggestions could include or expand upon comments submitted in response to the FY 2018 Hospital Inpatient Prospective Payment System for Acute Care Hospitals and the Long-Term Care Hospital Prospective Payment System RFI, found at
The most useful comments will be those that include data or evidence to support the position, offer suggestions to amend specific sections of the existing regulations, or offer particular additions.
On October 29, 2013, we published a final rule (78 FR 209) that established, for the first time, a set of requirements that Medicare-certified CMHCs must meet in order to participate in the Medicare program. These CoPs ensure the quality and safety of CMHC care for all clients served by the CMHC, regardless of payment source. These requirements focus on a person-centered, outcome-oriented process that promotes quality client care. These CoPs are set forth at 42 CFR part 485 and apply to all Medicare participating CMHCs.
Medicare certified CMHCs provide services to a wide range of clients, from those needing partial hospitalization program (PHP) services to clients needing routine counseling. Partial hospitalization services are an intense level of services needed “to improve or maintain the individual's condition and functional level and to prevent relapse or hospitalization. . . .” (section 1861(ff)(2) of the Act). As written, the current standard at § 485.914(d) requires the CMHC to update the client comprehensive assessment every 30 days regardless of the client's needs or treatment schedule. This 30 day update of the comprehensive assessment correlates with the CMS PHP payment regulations, requiring PHP clients to receive an updated active treatment plan every 30 days. Clients receiving PHP are more acute and typically receive care in the CMHC multiple days a week for several hours a day. The PHP client will have changing needs as they progress through their treatment plan; therefore, updating the assessment every 30 days or sooner if the client's condition changes continues to be an important requirement for the PHP client.
While the minimum 30 day update time fame at § 485.914(d) is needed for clients receiving PHP services, we do not believe that this time frame requirement supports the needs of all CMHC clients. Clients that do not receive PHP services may be seen weekly or every 2 weeks, while others are only seen every 2-6 months for a medication follow up. Requiring an updated assessment every 30 days may not be practical for the non-PHP client, causing either additional visits or phone calls from the CMHC to the client to document “no changes in the client's assessment”. This is not an efficient use of CMHC clinician or client time. Therefore, we propose to modify this standard at § 485.914(d)(1) to require that the CMHC update each client's comprehensive assessment via the CMHC interdisciplinary treatment team, in consultation with the client's primary health care provider (if any), when changes in the client's status, responses to treatment, or goal achievement have occurred, and in accordance with current standards of practice. Additionally at § 485.914(d)(3), we propose to retain the minimum 30 day assessment update time frame for those clients who receive PHP services. We believe this proposed change will allow for the provider and client to choose a visit schedule that is appropriate for the client's condition and not cause extra work or time for documentation that is unnecessary. Ultimately, this proposed change may allow for greater flexibility for the provider and client, saving time for both.
We seek to reduce burdens for health care providers and patients, improve the quality of care, decrease costs, and ensure that patients and their providers and physicians are making the best health care choices possible. Therefore, we are soliciting public comments on additional regulatory reforms for burden reduction in future rulemaking. Specifically, we are seeking public comment on additional proposals or modifications to the proposals set forth in this rule that would further reduce burden on CMHCs and create cost savings, while also preserving quality of care and patient health and safety. Consistent with our “Patients Over Paperwork Initiative,” we are particularly interested in any suggestions to improve existing
The most useful comments will be those that include data or evidence to support the position, offer suggestions to amend specific sections of the existing regulations, or offer particular additions.
Portable x-rays are basic radiology studies (predominately chest and extremity x-rays) performed on patients in skilled nursing facilities, residents of long term care facilities and homebound patients. Under the authority of section 1861(s)(3) of the Act, the Secretary has established the CfCs that the supplier of portable x-ray services must meet to participate in Medicare and Medicaid, and these conditions are set forth at §§ 486.100 through 486.110. The portable x-ray CfCs set forth at § 486.104 were originally published on January 10, 1969 (34 FR 388) and were redesignated on September 30, 1977 (42 FR 528260), and amended on April 12, 1988 (53 FR 12015), August 30, 1995 (60 FR 45086), and November 19, 2008 (73 FR 69942). The portable x-ray CfCs set forth at § 486.106 were originally published on January 10, 1969 (34 FR 388) and were redesignated on September 30, 1977 (42 FR 52826) and further redesignated and amended January 9, 1995 (60 FR 2326), August 30, 1995 (60 FR 45086), and November 16, 2012 (77 FR 69372). The November 2012 revision to the portable x-ray requirements allowed nurse practitioners and non-physician providers acting within their scope of practice to order portable x-ray studies. The current regulations are inconsistent with other rules governing diagnostic studies, as described later in this section of this proposed rule. In order to improve consistency, we propose changes to both § 486.104, Condition for coverage: Qualifications, orientation and health of technical personnel and § 486.106, Condition for coverage: Referral for service and preservation of records.
At § 486.104, Condition for coverage: Qualifications, orientation and health of technical personnel, the portable x-ray technologist must meet any one of four training and education requirements in § 486.104(a)(1), (2), (3), or (4). The requirement focuses on the accreditation of the school rather than the competency of the individual. In contrast, § 482.26(c)(2), referring to qualifications of radiologic technologists in hospitals, is focused on the qualifications of the individual performing services as permitted by State law. Additionally, § 410.33(c), which sets forth the personnel requirements for non-physician personnel used by an independent testing facility to perform tests, requires that testing personnel, including x-ray technologists, must demonstrate the basic qualifications to perform the tests in question and have training and proficiency as evidenced by licensure or certification by the appropriate State health or education department. These two other regulatory requirements that govern the same type of technologists do not have any accreditation requirements. Based on our survey findings in hospitals, which have not identified widespread patient safety or quality of care concerns related to the training and education levels of technologists, we do not believe that removing the school accreditation requirement from the portable x-ray personnel requirements would negatively impact portable x-ray patient health and safety.
We propose to remove the four training and education requirements for two reasons. First, paragraph (a)(1), and to some extent paragraph (a)(4), focus on the accreditation of the school where the technologist received training, instead of focusing on the qualifications of the technologist performing the diagnostic test. Radiologic technicians who practice in a hospital, and for whom there are no requirements to receive education and training by an accredited program, are legally allowed to perform any diagnostic imaging procedure, including computed topography scans, mammograms, sonograms, and many other procedures that are more complex and require more expertise than portable x-rays. In contrast, portable x-ray radiologic technicians typically perform basic x-rays of the limbs (hand, foot) and chest, and are limited in their duties by State scope of practice rules. For this reason we are aligning the current requirements at § 486.104(a)(1), (2), (3), and (4) with § 482.26(c)(2), which refers to qualifications of radiologic technologists in hospitals, and is focused on the qualifications of the individual performing services as permitted by State law. This change would not preclude state licensure entities and portable x-ray suppliers from establishing personnel requirements that are more stringent that the proposed Federal requirements.
Second, paragraphs (a)(2), (3), and (4) establish different personnel qualifications based on the date that a technologist received his or her education and training. We do not believe that it is efficient or necessary to have varying qualifications based simply on the date that such training was received. We propose to replace these four different qualifications with a single, streamlined qualification that focuses on the skills and abilities of the technologist. We believe that removing school accreditation requirements and simplifying the requirements will reduce regulatory burden, streamline the hiring process, and widen the pool of individuals who may be employed by portable x-ray suppliers to perform portable x-ray services, particularly those individuals who received training through the military for performing portable x-rays, as military training programs are not accredited.
Section 486.106(a)(2) contains specific requirements for the content of the order for portable x-ray services, and requires that physician or non-physician practitioners orders for portable x-ray services must be written and signed. The requirements at § 486.106(a)(2) are inconsistent with the order requirements at § 410.32, which also apply to portable x-ray suppliers, in two ways. First, the requirements at § 486.106(a)(2) have different order content requirements. Second, the requirements at § 486.106(a)(2) have the effect of limiting or precluding telephonic and electronic orders, which are often more efficient ordering methods. Section 410.32 allows for the diagnostic service to be ordered in writing, by telephone, or by secure electronic methods. Although, § 410.32 does not prescribe the form of an order. The Medicare Benefit Policy Manual (Pub. 100-02), chapter 15, section 80.6 provides additional guidance on § 410.32, and states:
“An order may be delivered via the following forms of communication:
• A written document signed by the treating physician/practitioner, which is hand delivered, mailed, or faxed to the testing facility; NOTE: No signature is required on orders for clinical diagnostic tests paid on the basis of the
• A telephone call by the treating physician/practitioner or his or her office to the testing facility; and
• An electronic mail by the treating physician/practitioner or his or her office to the testing facility.
If the order is communicated via telephone, both the treating physician/practitioner or his or her office, and the testing facility must document the telephone call in their respective copies of the beneficiary's medical records. While a physician order is not required to be signed, the physician must clearly document, in the medical record, his or her intent that the test be performed.
We propose to update § 486.106 (specific to portable x-ray services) to cross reference the requirements at § 410.32. We propose to retain the requirement that the portable x-ray order must include a statement on why it is necessary to perform a portable x-ray as opposed to performing the study in a facility where x-rays are more typically performed. This change would allow for portable x-ray services to be ordered in writing, by telephone, or by electronic methods. The change would also streamline the ordering process by avoiding the need to write two separate orders for the same study, one to meet the Medicare payment requirements in accordance with § 410.32 and its associated Manual guidance, and another to meet the content requirements of the regulation set forth at § 486.106. We believe the proposed change would allow for additional ordering flexibility to streamline ordering practices while maintaining ordering and documentation requirements consistent with all other diagnostic testing.
We seek to reduce burdens for health care providers and patients, improve the quality of care, decrease costs, and ensure that patients and their providers and physicians are making the best health care choices possible. Therefore, we are soliciting public comments on additional regulatory reforms for burden reduction in future rulemaking. Specifically, we are seeking public comment on additional proposals or modifications to the proposals set forth in this rule that would further reduce burden on suppliers of portable x-ray services and create cost savings, while also preserving quality of care and patient health and safety. Consistent with our “Patients Over Paperwork Initiative,” we are particularly interested in any suggestions to improve existing requirements, within our statutory authority, where they make providing quality care difficult or less effective. We also note that such suggestions could include or expand upon comments submitted in response to the RFI that was included in the CY 2018 Revisions to Payment Policies under the Physician Fee Schedule and Other Revisions to Part B. Public comments in response to this RFI can be found at the following link:
The most useful comments will be those that include data or evidence to support the position, offer suggestions to amend specific sections of the existing regulations, or offer particular additions.
Currently, § 491.9(b)(4) requires RHCs and FQHCs to have their patient care policies reviewed at least annually by the designated group of professional personnel who advise the RHC or FQHC in developing these policies (described at § 491.9(b)(2)), and reviewed as necessary by the RHC or FQHC. We propose to reduce the frequency of policy reviews. We believe the requirement to review patient care policies annually is burdensome and diverts staff from providing patient care. We propose to require the patient care policies be reviewed on a biennial basis by the group of professional personnel. Changing the review requirement from annually to every other year would not preclude the RHC or FQHC from maintaining their current annual review, if they believe it is necessary or if it is required by facility policy. We believe that this approach would allow RHCs and FQHCs to maintain their health and safety policies in such a manner as to achieve the intended outcomes for all patients. Thus, we propose to change the requirement at § 491.9(b)(4) from “annual” to “biennial”.
The current requirement at § 491.11(a) requires that the RHC or FQHC carries out, or arranges for, an annual evaluation of its total program. Some RHCs and FQHCs have reported to us that this requirement is burdensome and utilizes costly staff resources. We propose to revise the current requirement at § 491.11(a) by changing the frequency of the RHC or FQHC evaluation from annually to every other year. The revised requirement would then require a biennial evaluation of its total program. Changing the program evaluation requirement from annually to every other year would not preclude the RHC or FQHC from conducting an evaluation more frequently or maintaining their current annual evaluation, if they believe it is necessary or if it is required by facility policy. Furthermore, the proposed changes would give the RHC or FQHC the flexibility to focus only on certain program areas, if they choose to do so, for the off year in-between required program evaluations. The proposed change would reduce the paperwork burden of the RHC or FQHC and allow clinicians to focus more on patient care. We believe that an evaluation of the RHC or FQHC's total program every other year is sufficient to ensure consistent quality of care, and that the change from annual to biennial would not negatively affect patient health and safety. We welcome the public's comments on these proposed changes.
We seek to reduce burdens for health care providers and patients, improve the quality of care, decrease costs, and ensure that patients and their providers and physicians are making the best health care choices possible. Therefore, we are soliciting public comments on additional regulatory reforms for burden reduction in future rulemaking. Specifically, we are seeking public comment on additional proposals or modifications to the proposals set forth in this rule that would further reduce burden on RHCs and FQHCs and create cost savings, while also preserving quality of care and patient health and safety. Consistent with our “Patients Over Paperwork” Initiative, we are particularly interested in any suggestions to improve existing requirements, within our statutory authority, where they make providing quality care difficult or less effective. We also note that such suggestions could include or expand upon comments submitted in response to RFIs that were included in the 2017 prospective payment regulations for most provider types. We refer readers to the public comments that were submitted in response to the RFI for the following 2017 payment regulations:
• End-Stage Renal Disease Prospective Payment System and Payment for Renal Dialysis Services Furnished to Individuals with Acute Kidney Injury, and End-Stage Renal
• CY 2018 Home Health Prospective Payment System Rate Update; Value-Based Purchasing Model; and Quality Reporting Requirements found at
• FY 2018 Hospice Wage Index and Payment Rate Update and Hospice Quality found at
• FY 2018 Hospital Inpatient Prospective Payment System for Acute Care Hospitals and the Long-Term Care Hospital Prospective Payment System RFI, found at
• CY 2018 Hospital Outpatient PPS Policy Changes and Payment Rates and Ambulatory Surgical Center Payment System Policy Changes and Payment Rates found at
• FY 2018 Inpatient Rehabilitation Facility Prospective Payment System found at
• FY 2018 Inpatient Psychiatric Facilities Prospective Payment System found at
• CY 2018 Revisions to Payment Policies under the Physician Fee Schedule and Other Revisions to Part B found at
• FY 2018 Prospective Payment System and Consolidated Billing for Skilled Nursing Facilities found at
Public comments on the RFIs can be found by searching for the terms “RFI” or “request for information” in the aforementioned 2017 payment regulation dockets on
The most useful comments will be those that include data or evidence to support the position, offer suggestions to amend specific sections of the existing regulations, or offer particular additions.
On September 16, 2016, we published a final rule entitled, “Medicare and Medicaid Programs; Emergency Preparedness Requirements for Medicare and Medicaid Participating Providers and Suppliers” (81 FR 63860), which established national emergency preparedness requirements for Medicare and Medicaid participating providers and suppliers (referred to collectively as “facilities” in the subsequent section) to plan adequately for both natural and man-made disasters and coordinate with Federal, State, tribal, regional, and local emergency preparedness systems. In that final rule, we emphasized the need for facilities to maintain access to healthcare services during emergencies, safeguard human resources, and maintain business continuity and protect physical resources. A facility's emergency preparedness program must include the following elements:
After the publication of that final rule, we continued to review and analyze the final emergency preparedness requirements and pertinent stakeholder feedback. Upon further review, we believe that some emergency preparedness requirements could be modified or eliminated to reduce provider and supplier burden while continuing to maintain essential emergency preparedness requirements that preserve the health and safety of patients in the United States. The following proposals would simplify the emergency preparedness requirements, eliminate duplicative requirements, and/or reduce the frequency with which providers and suppliers would need to perform certain required activities. We note that the current emergency preparedness standards are similar amongst all provider and supplier types, with a few variations to account for differences in health care settings. For clarity in the discussion later in this section of this proposed rule, we often refer to the hospital regulatory citation and we include specific references to other provider or supplier types when necessary.
Facilities are currently required to annually review their emergency preparedness program, which includes a review of their emergency plan, policies and procedures, communication plan, and training and testing program. However, pertinent stakeholders continue to question whether an annual review of the emergency program is necessary or beneficial to the facility. In response to their comments, we are therefore proposing to change this requirement to require facilities to review their program at least every 2 years. This will increase the facility's flexibility to review their programs as they determine best fits their needs. We expect that facilities would routinely revise and update their policies and operational procedures to ensure that they are operating based on best practices. In addition, facilities should update their emergency preparedness program more frequently than every 2 years as needed (for example, if staff changes occur or lessons-learned are acquired from a real-life event or exercise).
As noted in the Emergency Preparedness final rule (81 FR 63860), “. . . there are various infections and diseases, such as the Ebola outbreak in October, 2014, that required updates in facility assessments, policies and procedures and training of staff beyond the directly affected hospitals. The final rule requires that if a facility experiences an emergency, an analysis of the response and any revisions to the emergency plan will be made and gaps and areas for improvement should be addressed in their plans to improve the response to similar challenges for any future emergencies.”
The Assistant Secretary for Preparedness and Response (ASPR) Technical Resources, Assistance Center, and Information Exchange (TRACIE) located at:
Facilities are currently required to develop and maintain an emergency preparedness plan that includes a process for cooperation and collaboration with local, tribal, regional, State, and Federal emergency preparedness officials' efforts to maintain an integrated response during a disaster or emergency situation, including documentation of the facilities' efforts to contact such officials and, when applicable, of its participation in collaborative and cooperative planning efforts. Upon further review of this requirement, we believe that elements of this requirement are unduly burdensome on facilities. Therefore, we propose to eliminate the requirement that facilities document efforts to contact local, tribal, regional, State, and Federal emergency preparedness officials and facilities' participation in collaborative and cooperative planning efforts. Facilities will still be required to include a process for cooperation and collaboration with local, tribal, regional, State and Federal emergency preparedness officials' efforts to maintain an integrated response during a disaster or emergency situation. We believe that eliminating this documentation requirement will reduce provider and supplier burden by not requiring facilities to demonstrate that they have contacted local, tribal, regional, State, and Federal emergency preparedness officials or participated in collaborative and cooperative planning in the community, while still requiring facilities to at least include a process for cooperation and collaboration. We continue to encourage facilities to participate, when available, in community cooperative and collaborative planning efforts and execute the training and testing requirements in § 482.15 (d) for hospitals and similar parallel citations for other facilities.
Facilities are required to develop and maintain a training program that is based on the facility's emergency plan. This emergency preparedness training must be provided at least annually and a well-organized effective training program must include initial training in emergency preparedness policies and procedures. We revisited the public comments received on the Emergency Preparedness proposed rule (81 FR 63890 through 63891) and determined that requiring facilities to provide annual training may be unduly burdensome. We are therefore proposing to change this requirement to require that facilities provide training biennially or every 2 years, after facilities conduct initial training on their emergency program. In addition, we propose to require additional training when the emergency plan is significantly updated. For example, when a facility makes substantial changes to the procedures or protocols within the emergency plan, we would require additional training on the updated emergency plan. Other non-significant updates, such as revisions to the communication plan regarding contact information for staff, could be sent in company memorandum or provided to the facility's staff through other means. These proposed changes give facilities additional flexibility to determine what is appropriate for their facility's or staff's needs while maintaining adequate readiness.
Facilities are currently required to conduct exercises to test the emergency plan at least annually. The facility must conduct two emergency preparedness testing exercises every year. Specifically, facilities must:
• Participate in a full-scale exercise that is community-based or when a community-based exercise is not accessible, an individual, facility-based. If the facility experiences an actual natural or-man made emergency that requires activation of the emergency plan (including their communication plan) and revision of the plan as needed), the facility is exempt from engaging in a community-based or individual, facility based full-scale exercise for 1 year following the onset of the actual event;
• Conduct an additional exercise that may include either a second full-scale exercise that is community-based or individual, facility-based or a tabletop exercise that includes a group discussion led by a facilitator.
Upon further analysis of this requirement, and taking into account stakeholder feedback, we have determined that there is also a need to clarify and revise some of the requirements included in the Emergency Preparedness final rule (81 FR 63860). We propose to clarify our intent with regard to the types of testing exercises, specifically full-scale exercises and functional exercises. As noted in the Emergency Preparedness proposed rule (78 FR 79101), a full-scale exercise is a multi-agency, multijurisdictional, multi-discipline exercise involving functional (for example, joint field office, emergency operation centers, etc.) and “boots on the ground” responses (for example, firefighters decontaminating mock victims). We expect facilities to engage in such comprehensive exercises with coordination across the public health system and local geographic area, if possible. Moreover, a functional exercise examines or validates the coordination, command, and control between various multiagency coordination centers (for example, emergency operation center, joint field office, etc.). A functional exercise does not involve any “boots on the ground” (that is, first responders or emergency officials responding to an incident in real time). The term “functional exercise” more accurately reflects our intentions for the testing requirement in the Emergency Preparedness final rule (81 FR 63860). We believe that there are opportunities to reduce the burden for inpatient and outpatient providers to meet the testing requirement.
For providers of inpatient services, we propose to expand the testing requirement options such that one of the two annually required testing exercises may be an exercise of their choice, which may include one community-based full-scale exercise (if available), an individual facility-based functional exercise, a drill, or a tabletop exercise or workshop that includes a group discussion led by a facilitator. As indicated in the Emergency
For providers of outpatient services, we believe that conducting two testing exercises per year is overly burdensome as these providers do not provide the same level of acuity or inpatient services for their patients. Therefore, we propose to require that providers of outpatient services conduct only one testing exercise per year. Furthermore, we propose to require that these providers participate in either a community-based full-scale exercise (if available) or conduct an individual facility-based functional exercise every other year. In the opposite years, we propose to allow these providers to conduct the testing exercise of their choice, which may include either a community-based full-scale exercise (if available), an individual, facility-based functional exercise, a drill, or a tabletop exercise or workshop that includes a group discussion led by a facilitator. Providers of outpatient services include ASCs, freestanding/home-based hospice, Program for the All-Inclusive Care for the Elderly (PACE), HHAs, CORFs, Organizations (which include Clinics, Rehabilitation Agencies, and Public Health Agencies as Providers of Outpatient Physical Therapy and Speech-Language Pathology Services), CMHCs, Organ Procurement Organizations (OPOs), RHCs, FQHCs, and ESRD facilities. Due to the nature of services provided by OPOs we propose to require that they have the option of providing either a tabletop exercise or workshop every year.
Lastly, we propose to clarify the testing requirement exemption by noting that if a provider experiences an actual natural or man-made emergency that requires activation of their emergency plan, inpatient and outpatient providers will be exempt from their next required full-scale community-based exercise or individual, facility-based functional exercise following the onset of the actual event. A facility's communication plan is part of their emergency plan, as is coordination with other community emergency preparedness officials (for example, emergency management and public health), and we expect that these elements, along with the completion of a corrective action plan, are part of the activation of their emergency plan.
We seek to reduce burdens for health care providers and patients, improve the quality of care, decrease costs, and ensure that patients and their providers and physicians are making the best health care choices possible. Therefore, we are soliciting public comments on additional regulatory reforms for burden reduction in future rulemaking. Specifically, we are seeking public comment on additional proposals or modifications to the proposals set forth in this rule that would further reduce burden on all Medicare and Medicaid participating providers and suppliers mentioned in this section and create cost savings, while also preserving quality of care and patient health and safety. Consistent with our “Patients Over Paperwork” Initiative, we are particularly interested in any suggestions to improve existing requirements, within our statutory authority, where they make providing quality care difficult or less effective. We also note that such suggestions could include or expand upon comments submitted in response to RFIs that were included in the following 2017 payment regulations:
• End-Stage Renal Disease Prospective Payment System and Payment for Renal Dialysis Services Furnished to Individuals with Acute Kidney Injury, and End-Stage Renal Disease Quality Incentive Program found at
• CY 2018 Home Health Prospective Payment System Rate Update; Value-Based Purchasing Model; and Quality Reporting Requirements found at
• FY 2018 Hospice Wage Index and Payment Rate Update and Hospice Quality found at
• FY 2018 Hospital Inpatient Prospective Payment System for Acute Care Hospitals and the Long-Term Care Hospital Prospective Payment System RFI, found at
• CY 2018 Hospital Outpatient PPS Policy Changes and Payment Rates and Ambulatory Surgical Center Payment System Policy Changes and Payment Rates found at
• FY 2018 Inpatient Rehabilitation Facility Prospective Payment System found at
• FY 2018 Inpatient Psychiatric Facilities Prospective Payment System found at
• CY 2018 Revisions to Payment Policies under the Physician Fee Schedule and Other Revisions to Part B found at
• FY 2018 Prospective Payment System and Consolidated Billing for Skilled Nursing Facilities found at
Public comments on the RFIs can be found by searching for the terms “RFI” or “request for information” in the aforementioned 2017 payment regulation dockets on
Under the Paperwork Reduction Act of 1995 (PRA), we are required to provide 60-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 are soliciting public comment on each of the section 3506(c)(2)(A)-
To derive average costs, we used data from the U.S. Bureau of Labor Statistics' May 2016 National Occupational Employment and Wage Estimates for all salary estimates (
Section 403.736 will reduce the extensive requirements for an RNHCI to coordinate with other medical providers for post-RNHCI care. The discharge evaluation must include an assessment of a patient's capacity for self-care and information regarding the care once the patient leaves the facility. The nursing staff would need to prepare the patient and/or their caregiver for discharge. Most patients are discharged to home or to another facility that adheres to the same religious tenets. Although all patients must have a discharge planning evaluation, not all patients require a discharge plan. Based on recent claims data, there was a combined annual total of 619 beneficiaries that stayed in the 18 facilities.
We estimate that the time currently required to develop and document discharge plans and activities is 1,238 burden hours (2 hours for each of the 619 beneficiaries discharged) and that it would be reduced by half. Of the approximately 619 annual discharges, we estimate that a RNHCIs burden would be reduced to one hour for each discharged individual. A RNHCI would not need to develop a discharge plan that includes medical care once a patient leaves the RNHCI because doing so would not be in keeping with the religious tenets of the patients they serve. We estimate that the healthcare support worker responsible for a patients discharge plan is paid at mean wage of $36, including 100 percent for fringe and overhead costs. Based on our experience with RNHCIs, we estimate that it would take 1 hour to develop the proposed discharge instructions and discuss them with the patient and/or caregiver. We estimate a total of 619 annual discharges from RNHCIs at a savings of $36 per discharge for a total savings of $22,284 ($36 × 619 hours).
We propose to eliminate the requirements at § 416.41(b)(3) that states the ASC must have a written transfer agreement with a hospital or ensure all physicians performing surgery in the ASC have admitting privileges at a local hospital that meets CMS hospitalization requirements. All ASCs easily meet this requirement and have established a relationship with their local hospital and obtained an agreement as usual and customary practice for running an ASC with the exception of approximately twenty ASCs that have difficult relationships with their local hospitals. The savings would not be significant, however, it does affect the 20 ASCs by removing the requirement. The current information collection request for the ASC rules (OMB control number 0938-1071) does not address any potential burden associated with this requirement. We believe that having and maintaining written agreements is standard practice. Therefore, removing this requirement would not alter the current information collection burden for ASCs.
We propose to revise § 416.47(b)(2) by adding the phrase “(as applicable)” to the significant medical history and results of physical examination requirement of documents that must be included in the medical record in order to conform to the changes that we are proposing to the mandatory medical history and physical examination requirement. There are no collection of information requirements associated with this proposed change because maintaining a medical record for each patient is a usual and customary practice in accordance with the implementing regulations of the PRA at 5 CFR 1320.3(b)(2).
At § 416.52 we propose to replace the requirement that every patient have a comprehensive medical history and physical examination (H&P) within 30 days prior to surgery in an ASC with a requirement that allows the operating physician and ASC to determine which patients would require more extensive testing and assessment prior to surgery. The burden associated with this requirement would be the time and effort necessary to create new policies for when, and whether, to require some form of history and physical that would require pre-operative examination and testing, and on what time schedule. The current information collection request for the ASC rules (OMB control number 0938-1071) does not account for any information collection related burden associated with the comprehensive H&P requirement. We assume that creating these policies (which could leave such decisions to the surgeon's discretion in most or all cases) would require 10 hours of physician time, 10 hours of RN time, and 10 hours of clerical time, at the preceding hourly rates, for a total of 30 hours per facility. This would be a one-time cost of $3,440 per facility ([10 × $243] + [10 × $69] + [10 × $32]), and $19.1 million for all 5,557 facilities. Therefore, this proposed requirement would increase the information collection related burden by $19.1 million and 166,710 hours (30 hours × 5,557 facilities) on a one-time basis for all ASCs. The information collection request will be revised to account for the additional burden.
At § 418.76(a) we propose to defer to State training and competency requirements, where they exist, for hospice aides. The information collection request for the hospice requirements (OMB control number 0938-1067) is currently under review at OMB. It estimates that a hospice would spend 5 minutes per newly hired hospice aide to document verification that an aide meets the required training and competency requirements, for a total of 372 annual burden hours for all hospices at a cost of $11,540. This proposed change to the actual training and competency requirements would not alter the requirement to document the fact that a hospice aide meets one of the training and competency requirements set forth in the rule; therefore there would be no change to the existing collection of information estimates because the estimates relate to the unchanged documentation requirements rather than the actual training and competency requirements that would be revised by this proposed change.
At § 418.106(a) we propose to remove the requirement that a hospice ensure that the interdisciplinary group confers with an individual with education and training in drug management as defined in hospice policies and procedures and State law, who is an employee of or under contract with the hospice to ensure that drugs and biologicals meet each patient's needs. The information collection request for the hospice requirements (OMB control number 0938-1067, currently under review at OMB) states that the burden associated with this requirement is the time necessary to document the results of this consultation in each patient's clinical record. In the information collection request we assumed that an average hospice would confer with a pharmacist, and that the pharmacist would document the results of his/her consultation. We estimated that it requires 5 minutes to document the initial review of a patient's drug and biologicals. Additionally, we estimated that it requires 5 minutes of the pharmacist's time to document a review of updates to the patient's drug profile. Based on a 17 day median length of service, we assumed that each patient would likely receive one update to their plans of care. At an average hourly rate of $115 for a pharmacist, we estimated that it would cost a hospice $19 per patient ($115 × [5 minutes for initial + 5 minutes for 1 update]) and an annual cost of $6,764 ($19 × 356 patients). The total annual burden hours for all hospices was estimated to be 264,588 hours (1,587,527 patients × .1666 hour per patient), and the total annual burden cost for all hospices was estimated to be $30,163,013 ($19 per patient × 1,587,527 patients). Therefore, removing the requirement that a hospice must ensure that the interdisciplinary group confers with an individual with education and training in drug management would result in a burden reduction of 264,588 hours and $30,163,013.
We assume that, upon implementation of the proposed change to allow hospices to provide information regarding the safe maintenance and disposal of controlled drugs in a more user-friendly manner, hospices would develop understandable instructions in layperson terms to replace the copy of the policies and procedures that is currently provided. While the instructions could be created in any number of formats, such as a slide show, video, podcast, or pictograph, for purposes of our analysis we assume that hospices would create written instructions. We estimate that a hospice would use 1 hour of administrator time to develop a new form at $105 per hour. For all 4,602 hospices, the total initial cost would be $483,210.
The information collection request will be revised and sent to OMB.
At § 418.112(f) we propose to allow hospices and long term care facilities the additional flexibility to negotiate the format and schedule for orienting long term care facility staff regarding certain hospice-specific information. A hospice and SNF/NF or ICF/IID must have a written agreement that specifies the provision of hospice services in the facility. The agreement must be signed by authorized representatives of the hospices and the SNF/NF or ICF/IID prior to the provision of hospice care services. The burden associated with this requirement is the time and effort necessary to develop, draft, sign, and maintain the written agreement. As stated in the hospice information collection request (OMB control number 0938-1067, currently under review at OMB), the use of this type of written agreement is a usual and customary business practice and the associated burden is exempt from the PRA under the implementing regulations at 5 CFR 1320.3(b)(2). However, updating the written agreement to address this new requirement would not constitute a usual and customary business practice; therefore, we believe that a one-time burden to update the written agreement would be imposed by this change. For purposes of this analysis only, we estimate that each hospice would use 8 hours of administrator time to revise the existing written agreement. At a cost of $105 per hour for an administrator to complete this task, we estimate that the onetime cost per hospice would be $840. For all hospices the onetime cost would be $3,865,680 (4,602 hospices × $840) for 36,816 hours (4,602 hospices × 8 hours). The information collection request will be revised to account for this one time increase in burden and sent to OMB.
We propose a new standard at § 482.21(f), “Unified and integrated QAPI program for multi-hospital systems”. We would allow that for a hospital that is part of a hospital system consisting of two or more separately certified hospitals subject to a system governing body legally responsible for the conduct of each hospital, the system governing body could elect to have a unified and integrated QAPI program for all of its member hospitals after determining that such a decision is in accordance with all applicable State and local laws. The system governing body would be responsible and accountable for ensuring that each of its separately certified hospitals meets all of the requirements of this section. Each separately certified hospital subject to the system governing body would have to demonstrate that: the unified and integrated QAPI program was established in a manner that took into account each member hospital's unique circumstances and any significant differences in patient populations and services offered in each hospital; and the unified and integrated QAPI program establishes and implements policies and procedures to ensure that the needs and concerns of each of its separately certified hospitals, regardless of practice or location, are given due consideration, and that the unified and integrated QAPI program has mechanisms in place to ensure that issues localized to particular hospitals are duly considered and addressed.
As stated in the information collection request for the hospital requirements (OMB control number 0938-0328), which is in the process of being reinstated, we estimate that the burden associated with updating and, in some instances, writing new hospital policies directly related to patient care would be an average of eight (8) hours annually for each member of hospital staff involved in the specific patient care policies addressed.
Patient care policy development (and revision) by hospital medical staff is essential to patient health and safety because it provides the framework within which all patient care services are furnished. Thus, we have included the involvement of a physician at approximately $1,584 annually (8 burden hours × $198), a QAPI nurse coordinator at $552 annually (8 burden hours × $69), and a medical secretary at $272 annually (8 burden hours × $34).
We estimate the necessary policy changes needed to comply with the requirements proposed in this rule would cost $2,408 per year ($1,584 + $552 + $272) for each of the 424 hospital systems that would be eligible to do so and that would choose to exercise this option. Therefore, the total annual cost for all eligible hospital systems to meet these information collection requirements would be approximately $1 million.
At § 416.52 we propose to replace the requirement that every patient have a comprehensive H&P within 30 days prior to surgery in an ASC with a requirement that allows the operating physician and ASC to determine which patients would require more extensive testing and assessment prior to surgery. As discussed in “Provisions of the Proposed Regulations,” section II.D.2 of this proposed rule, there is a similar regulatory requirement for hospital outpatient surgery. Based on the substantial similarity between these two service settings, we propose, through the revisions to §§ 482.22, 482.24, and 482.51 discussed in section II.D.2, to provide an exception to these requirements for outpatient surgery in hospitals.
As stated in the information collection request for the hospital requirements (OMB control number 0938-0328), which is in the process of being reinstated, we estimate that the burden associated with updating and, in some instances, writing new hospital policies directly related to patient care would be an average of eight (8) hours annually for each member of hospital staff involved in the specific patient care policies addressed.
Patient care policy development (and revision) by hospital medical staff is essential to patient health and safety because it provides the framework within which all patient care services are furnished. Thus, we have included the involvement of a physician at approximately $1,584 annually (8 burden hours × $198), a nurse coordinator at $552 annually (8 burden hours × $69), and a medical secretary at $272 annually (8 burden hours × $34).
We estimate that the necessary policy changes needed to comply with the requirements proposed in this rule would cost $2,408 per year ($1,584 + $552 + $272) for each of the 5,031 hospitals that might choose to exercise this option. Therefore, the total annual cost for all hospitals to meet these information collection requirements would be approximately $12.1 million.
We propose to remove the requirement at § 482.22(d), which recommends that a hospital's medical staff attempt to secure autopsies in all cases of unusual deaths and of medical-legal and educational interest. Hospitals are further required to define a mechanism for documenting permission to perform an autopsy, and they must have a system for notifying the medical staff, and specifically the attending practitioner, when an autopsy is being performed. Since more detailed, specific requirements regarding medical-legal investigations and autopsies for
We propose a new standard at § 482.42(c), “Unified and integrated infection control program for multi-hospital systems.” Like the proposed requirements for a unified and integrated QAPI program, the proposed standard for infection control would allow that for a hospital that is part of a hospital system consisting of multiple separately certified hospitals subject to a system governing body legally responsible for the conduct of each hospital, such system governing body could elect to have a unified and integrated infection control program for all of its member hospitals after determining that such a decision was in accordance with all applicable State and local laws. The system governing body would be responsible and accountable for ensuring that each of its separately certified hospitals met all of the requirements of this section. Each separately certified hospital subject to the system governing body would have to demonstrate that the unified and integrated infection control program: (1) Was established in a manner that took into account each member hospital's unique circumstances and any significant differences in patient populations and services offered in each hospital; (2) established and implemented policies and procedures to ensure that the needs and concerns of each of its separately certified hospitals, regardless of practice or location, were given due consideration; (3) had mechanisms in place to ensure that issues localized to particular hospitals were duly considered and addressed; and (4) has designated a qualified individual(s) with expertise in infection prevention and control at the hospital to be responsible for communicating with the unified infection control program, for implementing and maintaining the policies and procedures governing infection control, and for providing infection prevention education and training to hospital staff.
As stated in the information collection request for the hospital requirements (OMB control number 0938-0328), which is in the process of being reinstated, we estimate that the burden associated with updating and, in some instances, writing new hospital policies directly related to patient care would be an average of eight (8) hours annually for each member of hospital staff involved in the specific patient care policies addressed.
Patient care policy development (and revision) by hospital medical staff is essential to patient health and safety because it provides the framework within which all patient care services are furnished. Thus, we have included the involvement of a physician at approximately $1,584 annually (8 burden hours × $198), an infection control nurse coordinator at $552 annually (8 burden hours × $69), and a medical secretary at $272 annually (8 burden hours × $34).
We estimate the necessary policy changes needed to comply with the requirements proposed in this rule would cost $2,408 per year ($1,584 + $552 + $288) for each of the 424 hospital systems that would be eligible to do so and that would elect to exercise this option. Therefore, the total annual cost for all eligible hospital systems to meet these information collection requirements would be approximately $1 million.
At §§ 482.58(b)(1) and 485.645(d)(1) (cross-referenced long-term care requirement at § 483.10(f)(9)) we propose to remove the requirement for hospital and CAH swing-bed providers to provide the right for patients to choose to or refuse to perform services for the facility and if they so choose; (a) document in the resident's plan of care, (b) noting whether the services are voluntary or paid and (c) provide wages for the work being performed given the location quality, and quantity of work requiring comparable skills. We believe this requirement is unduly burdensome as we do not expect patient's receiving hospital or CAH swing-bed services have an average length of stay long enough to be positively impacted by providing services to the facility. We assume that each of the hospital swing-bed providers (478 hospitals) and CAH swing-bed providers (1,246 CAHs) has an activities specialist employed at $40 per hour who would oversee the residents who have chosen to perform services for the facility, and document and update the plan of care accordingly. We believe that given the limited budget of most rural providers, services are being provided to the CAH on a voluntary basis and that these providers are not compensating patients for providing these services. The current regulatory burden for compliance with this requirement is approximately $29 million for all hospital and CAH swing-bed providers, or $16,821 per hospital or CAH swing-bed provider (1,724 hospital and CAH swing-bed providers × $40 an hour for an activities specialist × 8 hours per week × 52 weeks per year), which are the cost savings to the providers as a result of the removal of this requirement.
At § 482.58(b)(4) (and § 485.645(d)(4)) (cross-referenced long-term care requirement at § 483.24(c)), we propose to remove the requirement for hospital and CAH swing-bed providers to provide an ongoing activity program that is directed by a qualified therapeutic recreation specialist or an activities professional who meets certain requirements as listed at § 483.24(c)(2). We assume that each of the hospital swing-bed providers (478 hospitals) and CAH swing-bed providers (1,246 CAHs) has an activities specialist employed at least part time at $40 per hour. CAHs are required to provide activity services by either a qualified individual who meet the requirements of § 483.24(c)(2), or by an individual on the facility staff who is designated as the activities director and who serves in consultation with a therapeutic recreation specialist, occupational therapist, or other professional with experience or education in recreational therapy. For the purpose of this analysis, we assume that the cost of each would be the same due to the rural location of CAHs. The current regulatory burden for compliance with this requirement is based on the activities specialist organizing, overseeing, and scheduling the activity. The cost savings as a result of the removal of this requirement are approximately $72 million for all hospital and CAH swing-bed providers, or $41,800 per hospital or CAH swing-bed provider (1,724 hospital and CAH swing-bed providers × $40 an hour for an activities specialist × 1,040 hours per year) which are the cost savings to the providers. Our analysis assumes that the reduced staffing is largely for part-time work assignment (1,040 hours annually) at hospital and CAH swing-bed providers. It is likely that many of the actual persons holding these positions were full-time workers not devoted solely to recreational therapy, whose hours will simply be reassigned to other functions, with providers ultimately saving these full-time equivalent hours through ripple effects on an even wider range of staffing functions through turnover over time.
We propose to remove the requirement at §§ 482.58(b)(5) and 485.645(d)(5) (cross-referenced long-
At §§ 482.58(b)(8) and 485.645(d)(8) (cross-referenced long-term care requirement at § 483.55(a)(1)) we propose to remove the requirement for hospital and CAH swing-bed providers to assist in obtaining routine and 24-hour emergency dental care to its residents.
Under the current CoPs, hospitals and CAHs are currently required to address the emergent dental care needs of their patients at § 482.12(f)(2) for hospitals, and at § 485.618 (emergency services) for CAHs. As a result, we have calculated the burden associated with the provision of routine dental care for hospital and swing-bed patients. The American Dental Association recommends annual dental checkups for routine dental care for adults over 60 years of age. With an average length of stay in a hospital or CAH swing-bed of 1-2 weeks and an average daily census of 2 patients, we assume that 1 patient receiving swing-bed services will require routine dental services per month. While a dentist and dental hygienist provide the dental services, Medicare is billed for the provision of these services. The costs to the provider are related to the nursing activities associated with the patient receiving the dental services. The current regulatory burden for compliance with this requirement is approximately $2.9 million for all hospital and CAH swing-bed providers, or $1,682 per hospital or CAH swing-bed provider (1,724 hospital and CAH swing-bed providers × $69 an hour for a RN × 24 hours per year), which are the cost savings to the providers as a result of the removal of this requirement. The information collection requests will be revised and sent to OMB for approval (OMB control number 0938-0328 for hospitals and 0938-1043 for CAHs).
At § 482.61(d) we propose to clarify the requirement allowing non-physician practitioners to document progress notes in accordance with State laws and scope of practice requirements. We believe this would apportion the burden associated with having MDs/DOs document their progress notes in psychiatric hospitals with non-physician practitioners and will decrease costs associated with this activity. In accordance with the information collection request for the hospital requirements, which includes the special requirements for psychiatric hospitals (OMB control number 0938-0328), no burden is associated with recordkeeping, as the documentation and maintenance of medical records is usual and customary. However, since we believe that clarification of the intent of the regulation is necessary and will result in non-physician practitioners (specifically physician assistants, nurse practitioners, psychologists, and clinical nurse specialists) documenting the progress notes for patients receiving services in psychiatric hospitals, we are attributing ICR burden savings for this provision. For purposes of this analysis only, we estimate that MDs/DOs spend approximately 30 minutes documenting progress notes in psychiatric hospitals. We estimate that 33 percent of this time would be covered by non-physician practitioners. Of the 5,031 Medicare participating hospitals, 574 (or 11 percent) are psychiatric hospitals. According to AHA, there were 35,061,292 inpatient hospital stays in 2015, and an estimated 11 percent of these stays were at psychiatric hospitals. The proposed change would result in a savings of $62.4 million (3,856,742 psychiatric hospital stays × 0.5 hours of physician/psychiatrist time × $98 per hourly wage difference between physicians/psychiatrists ($198) and non-physician practitioners ($100, the average wage between nurse practitioners and physician assistants) × 33 percent of physician time spent writing progress notes covered by non-physician practitioners). This savings is equivalent to $108,647 per psychiatric hospital per year.
We are proposing a nomenclature change at part 482 and the transplant center regulations at §§ 482.68, 482.70, 482.72 through 482.104, and at § 488.61. Because this change would update the terminology used in the regulations to conform to the terminology that is widely used and understood within the transplant community, there are no collection of information requirements associated with this proposal.
Section 482.82 requires that, except as specified in § 488.61, transplant centers must meet all the data submission, clinical experience, and outcome requirements to be re-approved for Medicare participation. Section 482.82(a) requires that no later than 90 days after the due date established by the OPTN, a transplant center must submit to the OPTN at least 95 percent of the required data submissions on all transplants (deceased and living donors) it has performed over the 3 year approval period. The required data submissions include, but are not limited to, submission of the appropriate OPTN forms for transplant candidate registration, transplant recipient registration and follow up, and living donor registration and follow up. Furthermore, § 482.82(b) requires transplant centers to perform an average of 10 transplants per year during the prior 3 years and § 482.82(c) requires transplant centers to meet the outcome requirements for Medicare re-approval. The burden associated with this requirement would be the time it would take a transplant program to submit the required information. However, as required by §§ 482.72 and 482.45(b), a hospital in which a transplant program is located, must belong to the OPTN, and the OPTN requires that these hospitals submit this data to the OPTN. Therefore, we believe that the requirements under § 482.82 do not impose an additional burden on transplant programs because all Medicare participating transplant programs are already submitting this information to the OPTN. Removing these requirements will have no additional collection of information burden on transplant programs. We describe additional life-saving benefits that result from the removal of this proposal in the subsequent RIA section.
Section 488.61(f) through (h) sets out the process for our consideration of a transplant center's mitigating factors in initial approval and re-approval surveys, certifications, and enforcement actions for transplant centers. The provisions also set out definitions and rules for transplant systems improvement agreements. We are proposing to remove the requirements at § 488.61(f) through (h) for mitigating
In total, we estimate that an average of 14 programs would submit mitigating factors annually. Thus, for those 14 programs we estimate that it would require 70 burden hours (5 burden hours × 14 programs) at a cost of $9,842 ($703 × 14 programs). In the context of this proposed rule, removing this requirement would yield an estimated savings to transplant programs of 5 burden hours each and a total of 70 burden hours for all 14 programs, with a total cost savings of $9,842.
In addition, we estimate that the transplant hospital in conjunction with the transplant program that is located in the hospital, would submit mitigating factors and then would also enter into systems improvement agreements, as described under § 488.61(h) annually. This would require the hospital to enter into a binding agreement with CMS to allow the program additional time to achieve compliance with the CoPs. The agreement would require hospitals to complete certain tasks as listed and described in § 488.61(h)(1), which include (but are not limited to): Patient notification about the degree and type of noncompliance by the program, an explanation of what the program improvement efforts mean for patients and financial assistance to defray the out-of-pocket costs of copayments and testing expenses for any wait-listed individual who wishes to be listed with another program, an external independent peer review team that conducts an onsite assessment of the program, an action plan that addresses systemic quality improvements and is updated after the onsite peer review, an onsite consultant who provides services for 8 days per month on average for the duration of the agreement, a comparative effectiveness analysis that compares policies, procedures, and protocols of the transplant program with those of other programs in areas of endeavor that are relevant to the center's current quality improvement needs, amongst other requirements listed in § 488.61(h)(1)(i) through (x). We estimate that this would take a medical director, a transplant program senior administrator, a hospital administrator, and an administrative assistant approximately 14 hours, or 4 hours for the medical director, transplant program senior administrator, and an administrative assistant, and 2 hours for the hospital administrator to complete these activities (including notifying patients about the degree of noncompliance by mail and organizing and completing the other tasks listed in § 488.61(h)(1) as required by the terms in the systems improvement agreement), as described in Table 3.
In total, we estimate that an average of 14 programs will submit mitigating factors annually. Thus, for those 14 programs we estimate that it would require 196 burden hours (14 burden hours × 14 programs) at a cost of $21,588 ($1,542 × 14 transplant programs). In the context of this proposed rule, removing this requirement would yield an estimated savings to transplant programs of 14 burden hours each and a total of 196 burden hours for all 14 programs, with a total cost savings of $21,588.
We propose to eliminate the requirement at § 484.80(h)(3) that the HHA conduct a full competency evaluation of deficient home health
We propose to remove the requirement at § 484.110(e) related to providing a requested copy of information contained in the clinical record at the next home visit, while retaining the requirement to provide the record within 4 business days. As stated in the January 2017 HHA CoP final rule (82 FR 4568 and 4575), we believe that providing such information to patients is a usual and customary practice that does not impose a burden upon HHAs and would not be subject to the PRA in accordance with the implementing regulations of the PRA at 5 CFR 1320.3(b)(2). As such, removing the “next home visit” timeframe requirement would not result in a savings of burden hours or dollars.
We propose to reduce the required frequency in which CORFs would be required to complete a “utilization review plan” from quarterly to annually. Changing from a quarterly implementation of the utilization review plan to an annual implementation would reduce the current documentation requirements (OMB control number 0938-1091) on CORFs by 75 percent each year. For the purposes of our analysis, we estimate that it would take a CORF approximately 8 hours for administrative, clinical and clerical staff to review and evaluate the necessary and efficient use of services provided by the facility on a quarterly basis, for a total of 32 hours per year per CORF and 6,016 hours for all 188 CORFs. In a 1-year period, we estimate a savings of $1,644 per facility ($548 × 3 quarters), and a combined total savings of $309,072 for all CORFs ($1644 × 188 CORFs). We will submit the revised information collection request to OMB for approval.
As of May 2017, there were 1,343 CAHs that are certified by Medicare. Our proposed revision of the CAH disclosure requirements imposed on CAHs would remove the requirement for CAHs to disclose to CMS its owners, or those with a controlling interest in the CAH or in any subcontractor in which the CAH directly or indirectly has a 5 percent or more ownership interest, in accordance with 42 CFR part 420, subpart C. While we estimate that these changes occur at 2 CAHs per year on average between all 1,343 CAHs, with the vast majority not experiencing any such changes throughout the lifetime of the CAH, each CAH is still required to review the duplicative documentation. In accordance with
Section 485.635(a)(4) requires CAHs to conduct an annual review of all its policies and procedures. Based on feedback from stakeholders, the prescriptive annual schedule is burdensome or, in some situations, ineffective. Our proposed revision of the patient care policies requirements imposed on CAHs would reduce the frequency that is currently required for CAHs to perform a review of all their policies and procedures. We propose that a change from an annual review to a biennial review would reduce the burden on CAHs by half in a given period of time. For the purposes of our analysis, we estimate that it would take a CAH approximately 16 hours for administrative and clinical staff to review and make changes to policies and procedures annually. In a 2-year period, we estimate a savings of $1,956.10 per facility, and a combined total savings of $2.6 million for CAHs ($1,956.10 × 1,343 CAHs).
We estimate that the CAH staff time and associated costs would be assigned to a biennial review as shown in Table 5.
We have included the discussion of the ICRs regarding special requirements for CAH providers of long-term care services in the discussion of the ICRs regarding special requirements for hospital providers of long-term care services which can be found under section L of this part.
Section 485.914(d)(1) requires each CMHC to update each client's comprehensive assessment via the CMHC interdisciplinary treatment team, in consultation with the client's primary health care provider (if any), no less frequently than every 30 days. We propose to modify the requirement at § 485.914(d) to remove the 30-day assessment update time frame for those clients who do not receive PHP services. Instead of a fixed 30-day time frame, assessment updates would be completed when changes in the client's status, responses to treatment, or goal achievement have occurred, and in accordance with current standards of practice. The burden associated with these requirements is the time required to record an updated assessment. The current information collection request (OMB Control number 0938-1245) does not account for any information collected related to the burden associated with updating the comprehensive assessment requirement. While in the past we believed that this is considered usual and customary practice, recent comments from the CMHC provider community, submitted in response to CMS' solicitation for public comments pertaining to burden reduction suggestions, stated that it is not usual and customary to update assessments for non-PHP clients on a 30 day schedule as required by the CMHC regulations. The commenters stated that the 30 day requirement was overly burdensome, and suggested that the CMHC assessment update requirement should more closely align with the patient-oriented approach of other entities that govern CMHC operations. Upon further consideration, we agreed with the commenter that the 30 day requirement does, in fact, impose a burden and is not usual and customary practice. Therefore, removing this requirement would reduce information collection burden for CMHCs.
Under the current 30-day time frame requirement, each client receives an updated assessment 12 times per year. We estimate that, in accordance with the proposed need-based assessment update requirements, each non-PHP client would receive 2 assessment updates in a year. Therefore, we estimate that this change would reduce the burden of 10 assessments per client, per year.
As of August 2017 there are 52 Medicare participating CMHCs serving 3,122 Medicare beneficiaries and an estimated 2,080 non-Medicare clients, for an average of 100 clients per CMHC. In order to develop the estimated number of non-Medicare clients we divided the total number of Medicare beneficiaries who received partial hospitalization services by the total number of Medicare-participating CMHCs to establish the average number of Medicare beneficiaries per CMHC. This resulted in 60 beneficiaries per CMHC. We then assumed that, in order to comply with the 40 percent requirement (§ 485.918(b)(1)(v)), those 60 beneficiaries only accounted for 60 percent of an average CMHC's total patient population. This means that an average CMHC also treated another 40 clients who did not have Medicare as a payer source, for a total of 100 clients (Medicare + non-Medicare) in an average CMHC. Therefore, all CMHCs combined would have approximately 2,080 non-PHP clients per year (40 per CMHC), and approximately 20,800 assessments would be reduced nationwide per year (2,080 patients × 10 assessments per patient). We estimate that documenting each assessment update requires 10 minutes of a CMHC clinician's time, for a total savings of 3,466 hours nationwide (1,666 hours × 20,800 assessment updates). At a cost of $7.33 for a mental health counselor to document each assessment, the total cost savings would be $152,464 ($7.33 × 20,800 assessments).
We propose to revise the requirements for portable x-ray technologist personnel qualifications at § 486.104 to align the current requirements at § 486.104(a)(1), (2), (3), and (4) with those for hospital radiologic technologists at § 482.26(c)(2) which are focused on the qualifications of the individual performing services as permitted by State law. Although changing the qualifications would require management time, with the associated cost of those hours, in order to revise the internal personnel descriptions and qualifications, we believe that this proposed change would impose no burden because maintaining internal personnel descriptions and qualifications is a standard business practice. Therefore, this burden would not be subject to the PRA in accordance with the implementing regulations of the PRA at 5 CFR 1320.3(b)(2).
We propose to revise the requirements for portable x-ray orders at § 486.106(a)(2). We propose to remove the requirement that physician or non-physician practitioner's orders for portable x-ray services must be written and signed. We also propose to replace the specific requirements related to the content of each portable x-ray order with a cross-reference to the requirements at 42 CFR 410.32, which also apply to portable x-ray services. These proposed changes would simplify the ordering process for portable x-rays and promote the use of more efficient ordering methods, such as electronic orders.
This change would allow for portable x-ray services to be ordered in writing, by telephone, or by electronic methods. The change would also streamline the ordering process by avoiding the need to write two separate orders for the same study, one to meet the Medicare payment requirements in accordance with § 410.32 and its associated Manual guidance, and another to meet the content requirements of the regulation set forth at § 486.106. We believe the proposed change would allow for additional ordering flexibility to streamline ordering practices. In the information collection request (OMB control number 0938-0338) we estimate
• 3 minutes to write an order × 3,986,000 portable x-rays exams ordered = 199,300 hours × $69/hour for a nurse = $13,751,700.
• $1 for printing and faxing verbal orders to physician offices for signature × 2,500,000 verbal orders = $2,500,000.
• 2,000,000 follow-up calls regarding the status of faxes × 10 minutes of time for clerical staff (5 minutes for portable x-ray clerical staff + 5 minutes for ordering physician clerical staff) = 333,333 hours × $32/hour = $10,666,656.
All of these burdens would be eliminated by revising the current ordering standards. Therefore, we estimate a proposed information collection savings of $26,918,356 from this proposed change.
There are currently more than 4,100 RHCs and approximately 1,400 FQHC organizations furnishing services at approximately 12,000 or more total locations. Many FQHC organizations have multiple delivery sites, so to be as accurate as possible, our burden reduction calculations are based on the most recent data available, which shows that as of May 2017, there were 4,160 RHCs and 7,874 FQHC delivery sites. All CMS-certified sites are subject to our requirements and we are therefore utilizing the total number of current sites in our burden reduction calculations.
We propose to revise § 491.9(b)(4) to reduce the number of times that RHCs and FQHCs perform a review of all their policies and procedures. Changing from an annual review to a review every other year would reduce the burden on RHCs and FQHCs by half in a given period of time. In the currently approved information collection request (OMB control number 0938-0334), we estimate that it would take a RHC or FQHC approximately 4 hours for clinical staff to review and make changes to policies and procedures annually, for a total of 48,136 hours for all 12,034 RHC and FQHC locations. In a 2-year period, RHCs and FQHCs would use 96,272 total hours to comply with the requirements to annually review all of their policies and procedures. Under the proposed change to a review every other year, we estimate that in a 2-year period, it will take a total of 48,136 hours, for a savings of 48,136 hours per year. We estimate a savings of $592 per facility (see Table 6) for a combined total savings of $7.1 million for 12,034 RHCs or FQHCs ($592 × 12,034 RHCs and FQHCs). We will submit a revised information collection request to OMB for approval.
We propose to revise § 491.11(a) to reduce the number of times that RHCs and FQHCs carry out or arrange for an annual evaluation of the total program. Changing from an annual evaluation to an evaluation every other year would reduce the burden on RHCs and FQHCs by half in a given period of time. In the currently approved information collection request (OMB control number 0938-0334), we estimate that it would take a RHC or FQHC approximately 6 hours for administrative and clinical staff to perform an evaluation of its total program annually for a total of 72,204 hours for all 12,034 RHC and FQHC locations. In a 2-year period, RHCs and FQHCs would use 144,408 total hours to comply with the requirement for an evaluation of the total program. Under the proposed change to evaluate the total program every other year, we estimate a hourly savings of 72,204 total hours and a cost savings of $802 per facility (see Table 7), for a combined total savings of $9.7 million for 12,034 RHCs or FQHCs ($802 × 12,034 RHC and FQHC locations).
At § 482.15(a), (b), (c), and (d) for hospitals and parallel regulatory citations for other facilities, we propose to allow providers to review their program at least every 2 years. As of May 2017, there were approximately 74,246 total facilities. All are required to review their emergency preparedness program annually, which includes a review of their emergency plan, policies and procedures, communication plan, and training and testing program.
For our analysis, we estimate that reducing this requirement from annually to biennially would reduce compliance costs related to review of the emergency plan by 50 percent. The methodology used for our cost estimate analysis generally mirrors the methodology used for the annual review of the emergency plan Emergency Preparedness final rule (81 FR 63930) with a 50 percent reduction in the cost estimate calculation; however, after receiving additional feedback from stakeholders, we have determined that we underestimated the amount of time it would take to review the emergency plan. As a result, we have presented current burden hours associated with reviewing the emergency plan that reflects the increased associated burden hours relative to the information collection request for this provision (OMB control number 0938-1325). As in the Emergency Preparedness final rule (81 FR 63930), we assume that the individuals involved in the review of the emergency plan include an administrator, director of nursing, a RN, a physician, a social worker, a counselor, and an office manager, depending on the facility type. Based on May 2016 BLS salary data, we calculated the hourly mean wage for each position for this requirement identified in the Emergency Preparedness final rule (81 FR 63930).
We estimate that the proposed change will accrue a total annual cost savings of $94,312,719 and 187 burden hours saved. We list a detailed calculation for each facility below, based on facility numbers available as of May 2017:
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At § 482.15(a)(4) for hospitals, and other parallel citations for the facilities mentioned in section II.J.2 of this proposed rule, we propose to eliminate the requirement that facilities document efforts to contact local, tribal, regional, State, and Federal emergency preparedness officials and that facilities document participation in collaborative and cooperative planning efforts. We estimate that an administrator, or in the case of a hospital a community relations manager, a program director for a PACE, or a QAPI director for OPOs, would take 1 hour to document efforts to contact local, tribal, regional, State and Federal emergency preparedness officials and, when applicable, document the facility's participation in collaborative and cooperative planning efforts. We note that the Joint Commission (TJC)-accredited ASCs, TJC-accredited CAHs, and TJC-accredited hospitals have emergency preparedness requirements for developing an emergency preparedness plan that are comparable to the current emergency preparedness CoPs (81 FR 63937, 63954, and 63978 through 63979). Utilizing the same assumptions we used in the Emergency Preparedness final rule (81 FR 63937, 63954, and 63978 through 63979), we estimate that cost savings will accumulate from non-TJC accredited ASC, CAHs, and hospitals, since TJC-accredited ASCs, CAHs and hospitals are already required by the TJC to develop emergency preparedness plans. As a result, these facilities are excluded from the analysis given the requirements of their accreditation organization standards. Based on May 2016 BLS salary data, we calculate an hourly mean wage of $105 for an administrator, a PACE Program Director, or QAPI director and a cost savings of $105 per facility for RNHCIs, non-TJC accredited ASCs, hospices (both inpatient and freestanding), PRTFs, PACEs, LTCFs, ICF/IIDs, HHAs, CORFs, non-TJC accredited CAHs, Organizations, CMHCs, OPOs, RHC/FQHCs, and dialysis facilities ($105 hourly mean wage × 1 burden hour). For non-TJC accredited hospitals, we estimate an hourly mean wage of $114 for a community relations manager, and a $114 cost per facility ($114 × 1 hour). Therefore, we estimate the following for each facility affected by the proposed change, for a total savings of $7,179,117 and 18 burden hours. We list a summary of the calculation for savings accrued by removing this requirement for each facility in Table 9, based on facility numbers available as of May 2017.
At § 482.15(d)(1)(ii) for hospitals, and other parallel citations for other facilities mentioned in section II.J.2 of this proposed rule, we propose to require that facilities provide training biennially, or every 2 years, after facilities conduct initial training on their emergency program. In addition, we propose to require additional training when the emergency plan is significantly updated. We believe that the annual training requirement is too prescriptive as annual may not always be necessary. We propose to maintain the requirement that providers and suppliers develop a well-organized, effective training program that includes initial training for new and existing staff in emergency preparedness policies and procedures and would require training when the emergency plan is significantly updated. Facilities would have the flexibility to determine what is considered a significant update to the emergency plan.
For our analysis, we estimate that reducing this requirement from annually to biennially will reduce compliance costs related to providing emergency preparedness training by 50 percent. The methodology used for our cost estimate analysis mirrors the methodology used for the annual training requirement in the Emergency Preparedness final rule (81 FR 63930) with a 50 percent reduction in the cost estimate calculation. As in the Emergency Preparedness final rule (81 FR 63930), we assume that the individuals involved in the development and provision of training include an administrator, director of nursing, a RN, and an office manager, depending on the facility type. Providers and suppliers are expected to provide initial training in emergency preparedness policies and procedures to all new and existing staff, individuals providing services under arrangement, and volunteers, consistent with their expected roles, and maintain documentation of the training. Based on May 2016 BLS salary data, we calculated the hourly mean wage for each position for this requirement identified in the Emergency Preparedness final rule (81 FR 63930). We estimate that the proposed change will accrue a total annual cost savings of $33,267,864 and 111 burden hours. We list a detailed calculation for each facility below, based on facility numbers available as of May 2017 with a summary of these calculations provided in Table 10:
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Finally, at § 482.15(d)(2), we propose to require that providers of inpatient services mentioned in section II.J.2 of this proposed rule conduct two testing exercises annually, one of which may be an exercise of their choice that must be either a community-based full-scale exercise (if available), an individual facility-based functional exercise, a drill, a tabletop exercise or workshop that includes a group discussion led by a facilitator. We estimate that revising this requirement to include additional options for the types testing exercises that may be conducted for one of the two annually required exercises will provide greater flexibility for these providers. Given that these providers are currently required to conduct two testing exercises annually, and because they may choose to conduct the same types of testing exercises, we do not anticipate that this requirement will impose a burden upon providers of inpatient services and as such, this revision would not result in a savings of burden hours or dollars.
We propose to require that providers of outpatient services mentioned in section II.J.2 of this proposed rule conduct one testing exercise annually which must be either a community-based full-scale exercise (if available) or an individual facility-based functional exercise every other year, and in the opposite years, may be either a community-based full-scale exercise (if available), a facility-based functional exercise, a drill, or a tabletop exercise or workshop that includes a group discussion led by a facilitator.
For our analysis, we estimate that reducing this requirement from biannually to annually for outpatient providers will reduce compliance costs related to conducting emergency preparedness testing by 50 percent. The methodology used for our cost estimate analysis mirrors the methodology used for the biannual testing requirement in the Emergency Preparedness final rule (81 FR 63930) with a 50 percent reduction in the cost estimate calculation. As in the Emergency Preparedness final rule (81 FR 63930), we will assume that the same individuals involved with developing training would typically also develop the scenarios, materials, as well as any accompanying documentation associated with testing exercises. Based on May 2016 BLS salary data, we calculated the hourly mean wage for each position for this requirement identified in the Emergency Preparedness final rule (81 FR 63930) and decreased the cost by 50 percent due to the 50 percent reduction in the frequency requirement.
We estimate that the proposed change will accrue a total annual cost savings of $9,117,425 and 25 burden hours. We list a detailed calculation for each facility below, based on facility numbers available as of May 2017 with a summary of these calculations provided in Table 11:
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We will submit a revised information collection request to OMB to account for the burden hour and cost savings.
Because of the large number of public comments we normally receive on
All major and many ostensibly minor government regulations should undergo periodic review to ensure that they do not unduly burden regulated entities or the American people, and reflect current knowledge as to regulatory effects. In recent years, we have revised the CoPs and CfCs to reduce the regulatory burden on providers and suppliers. In doing so, we identified obsolete and burdensome regulations that could be eliminated or reformed to improve effectiveness or reduce unnecessary reporting requirements and other costs, with a particular focus on freeing up resources that health care providers, health plans, and States could use to improve or enhance patient health and safety. We also examined policies and practices not codified in rules that could be changed or streamlined to achieve better outcomes for patients while reducing burden on providers of care, and we identified non-regulatory changes that would increase transparency and allow CMS to become a better business partner. In accordance with these goals, we published three final rules that identified unnecessary, obsolete, or excessively burdensome regulations on health care providers, suppliers, and beneficiaries. These rules further increased the ability of health care professionals to devote resources to improving patient care by eliminating or reducing requirements that impede quality patient care or that divert providing high quality patient care:
• “Reform of Hospital and Critical Access Hospital Conditions of Participation”, published May 16, 2012 (77 FR 29034);
• “Regulatory Provisions to Promote Program Efficiency, Transparency, and Burden Reduction”, published May 16, 2012 (77 FR 29002) and;
• “Regulatory Provisions to Promote Program Efficiency, Transparency, and Burden Reduction; Part II”, published May 12, 2014 (79 FR 27105).
This proposed rule is not just a continuation of our efforts to reduce regulatory burden but also directly responds to the January 30, 2017 Executive Order “Reducing Regulation and Controlling Regulatory Costs” (Executive Order 13771). We propose changes to the current CoPs or CfCs that will simplify and streamline the current regulations and thereby increase provider flexibility and reduce excessively burdensome regulations, while also allowing providers to focus on providing high-quality healthcare to their patients. This proposed rule will also reduce the frequency of certain required activities and, where appropriate, revise timelines for certain requirements for providers and suppliers and remove obsolete, duplicative, or unnecessary requirements. Ultimately, these proposals balance patient safety and quality, while also providing broad regulatory relief for providers and suppliers, and reducing the associated burden on patients.
We have examined the impacts of this 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
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). Section 3(f) of Executive Order 12866 defines a “significant regulatory action” as an action that is likely to result in a rule: (1) Having an annual effect on the economy of $100 million or more in any 1 year, or adversely and materially affecting a sector of the economy, productivity, competition, jobs, the environment, public health or safety, or state, local or tribal governments or communities (also referred to as “economically significant”); (2) creating a serious inconsistency or otherwise interfering with an action taken or planned by another agency; (3) materially altering the budgetary impacts of entitlement grants, user fees, or loan programs or the rights and obligations of recipients thereof; or (4) raising novel legal or policy issues arising out of legal mandates, the President's priorities, or the principles set forth in the Executive Order.
A regulatory impact analysis (RIA) must be prepared for major rules with economically significant effects ($100 million or more in any 1 year). We estimate that this rulemaking is “economically significant” as measured by the $100 million threshold, and hence also a major rule under the Congressional Review Act. Accordingly, we have prepared a RIA that, to the best of our ability, presents the costs and benefits of the rulemaking.
In accordance with the provisions of Executive Order 12866, this regulation was reviewed by the Office of Management and Budget. This proposed rule would create ongoing cost savings to providers and suppliers in many areas. Other changes we have proposed would clarify existing policy and relieve some administrative burdens. We have identified other kinds of savings that providers and patients will realize throughout this preamble, and substantial lifesaving benefits. These life-saving effects arise by removing the incentives created by the current transplant center regulations to decline to transplant patients with slightly lower probability of success, and to decline to use organs with a slightly lower probability of success.
We welcome public comments on all of our burden assumptions and estimates as well as comments identifying additional reforms that should be considered for future rulemakings. As discussed later in this regulatory impact analysis, substantial uncertainty surrounds these estimates and we especially solicit comments on either our estimates of likely impacts or the specific regulatory changes that drive these estimates.
As stated in the ICR section of this proposed rule, we obtained all salary information from the May 2016 National Occupational Employment and Wage Estimates, United States by the Bureau of Labor Statistics (BLS) at
As detailed in the Collection of Information section of this rule, we propose to reduce the discharge planning requirements for RNHCIs because RNHCIs do not provide medical treatment or services. Most patients are discharged to home or to another facility that also does not provide medical treatment or services. Although all patients must have a discharge planning evaluation, not all patients require a discharge plan. The discharge planning cost would be reduced by an estimated $27,013.16.
As of May 2017 there were 5,557 Medicare-participating ASCs. We proposed to revise the ASC CfCs in order to reduce unnecessary duplications and streamline processes in order to reduce ASC compliance burden while maintaining minimum standards for patient safety and care. The specific savings for each proposed change are described later in this section of this proposed rule. At § 416.41(b)(3), we propose to remove the requirements related to transfer agreements and admitting privileges. This change would eliminate the administrative burden associated with preparing an agreement for signature and going through the hospital credentialing process in order to obtain admitting privileges. Currently, all Medicare-certified ASCs are meeting the transfer agreement or admitting privileges requirement with the exception of approximately twenty ASCs that have tenuous relationships with their local hospital. We estimate the ASCs that do have difficulty with meeting this requirement would appreciate the annual burden savings of 2 to 4 administrator hours spent on paperwork and documentation. For those already with the transfer agreements in place, there would not be any more follow-up burden related to renewals or updates to the documents. We estimate the savings at less than $10,000 overall and largely believe this change will not produce significant savings, however, it does affect twenty or more ASCs in the short term by removing the transfer agreement requirement. We welcome any feedback related to the time and effort for those ASCs that have secured an agreement, and if we have underestimated the savings of removing this transfer agreement in the future. As previously discussed, the enactment of EMTALA and its increasingly effective enforcement over time has rendered these transfer and admitting privileges obsolete and unnecessary. To put this point in perspective, emergencies or other unforeseen adverse events can arise in any ambulatory medical or dental setting, or in home settings. Over time, “911” emergency calls and direct ambulance responses have become standard operating procedures virtually nationwide, regardless of the place in which the problem arose. Under modern procedures, emergency responders (and patients themselves) take patients to hospital emergency rooms without regard to prior agreements between particular physicians and particular hospitals. Indeed, the most appropriate emergency treatment setting for a particular patient may not be one involving such an agreement even where the agreement exists. Of course, nothing prevents particular arrangements where a hospital and ASC agree that this is beneficial for a particular type of surgery or patient condition and where patient transport can be appropriately arranged to reflect this. Accordingly, we estimate that there will be no consequential adverse health effects of this proposed change, and therefore estimate no medical costs.
There will be competitive benefits in those places where an ASC will now be allowed to operate and provide care at reduced cost compared to inpatient treatment. Nonetheless, we believe that the number of affected areas and facilities are few, and that annual benefits are unlikely to reach the
At § 416.52 we propose to replace the requirement that every patient must have a comprehensive H&P within 30 days prior to surgery in an ASC with a requirement that allows the operating physician and ASC to determine which patients would require more extensive testing and assessment prior to surgery. We believe that this change would reduce patient and provider burden in a multitude of ways that includes the community-based physician, the ASC, and the patient. We believe that in almost all situations ASCs can reasonably rely on existing H&P results that are more than 30 days old and then are updated by patient responses on the day of surgery, but we cannot forecast with any precision what medical specialty societies, ASC governing bodies, hospital governing bodies, or accreditation bodies will decide to do in replacing the current requirement. Therefore, we do not forecast specific cost savings at this time, and solicit public comments to help us with our estimate in the final rule.
For ASCs, we believe this change would reduce administrative burden by decreasing the amount of time that ASC personnel spend following up on patient visits to obtain the necessary H&P information and that it will provide for an increase in scheduling flexibility for the facility. We believe these changes may have the effect of improving patient satisfaction and increasing positive patient referrals for the ASC.
For community-based healthcare providers, to include primary care providers, we believe this change would reduce unnecessary examinations that are required to be performed and reduce administrative paperwork burden associated with providing ASCs with the necessary H&P documentation and additional testing requirements. This change may potentially provide an opportunity for increased access to community-based providers because of available appointments that are not being filled by unnecessary patient appointments for H&P requirements for surgery in an ASC. Those vacant appointments may also generate more revenue.
For patients, we believe this change would reduce the time spent to prepare for surgery (time in community-based physician office, travel time and costs, time missed from the work place and lost productivity) and the cost associated with co-pays and other healthcare cost sharing requirements.
Finally, we believe this change would reduce expenses for healthcare insurers to include Medicare, Medicaid, and private healthcare insurance companies. This change would reduce costs associated with reduced pre-operative exams, laboratory testing, chest radiographs, and echocardiograms.
It is difficult to estimate the savings from this change, because they depend on a number of factors previously described, and additional factors for which we do not have precise measures, such as the number of patients (both Medicare and non-Medicare) who received two or more ASC services within the 30-day window allowed for one physical examination. This is a common occurrence because, for example, patients often receive cataract surgery on one eye and then, a week later, on the other eye. Furthermore, there are an immense number of different outpatient surgical services. At present, for example, there are about 137 services that account for about 90 percent of ASC volume, and these services are highly diverse, as shown in Table 13.
In total, ASCs provided about 6.4 million services in 2015 (MEDPAC. Ambulatory surgical centers services, 2017, p. 139). If we assume that 25 percent of these had two or more services within the 30-day “window” allowed in the current rule, then another H&P with its associated battery of tests were required for each of the remaining 4.8 million individuals. Assuming that 5 percent of these would otherwise have already had an overall H&P and associated tests within 30 days of the surgery, 4.56 million persons would then require a new H&P and tests before surgery under the current requirements. In the great majority of cases involving eye or eyelid surgery of one kind or another, the ophthalmology examination preceding the ASC surgery would not have involved a
Although we are unable to estimate the likely number of cases, one way to estimate the costs of these examinations and tests would be as follows. First, the H&P itself would cost approximately $100 (the exact amount depending on diagnostic details, and not necessarily corresponding to any particular payment schedule). The battery of tests would cost approximately $100, assuming both urine and blood testing, and, in some cases, an electrocardiogram, but only half of physical examinations (for example, few or no ophthalmologist exams) would include such tests. The travel of the patient to and from the physician office to obtain the examination and tests would on average require 1 hour, which when valued at the average wage rate in the economy of $24 (increased by 50 percent to include fringe benefits but not overhead) would cost about $36. In addition, ASCs incur substantial costs for the time and trouble needed to contact physician offices and arrange for the results to be delivered. The physician offices themselves would be put through the trouble of transferring those medical records. Assuming average time spent (the median would be less but a small number of difficult cases would bring the average well above the median) would reach 10 minutes, and the use of a general office clerk at $32 an hour, the cost per patient would average $5 per patient. A further cost arises because in many cases the examination and test results simply cannot be obtained timely, and a scheduled surgery has to be postponed. Assuming that in such cases a half hour of surgeon time (at $243 an hour) and a half hour of registered nurse (RN) time (at $69 an hour) is wasted, and that clerical time ($32 an hour) to reschedule averages 10 minutes, the average cost per postponement would be $161. (In some of these cases patient time would be wasted, as well as the time of family members accompanying the patient—we have not estimated these costs.)
Aggregating these calculations, one estimate of the annual costs of the current regulatory requirement, as shown in Table 14, could be as much as $972 million for ASCs and a similar amount for hospital outpatient surgery. For many and perhaps most cases, however, either the surgeon or the facility would decide that H&P information is needed for particular patients or particular procedures whether or not this regulatory requirement existed. Of course, it is unlikely that in such cases a strict 30-day window would be insisted on. Assuming that such examination and testing information would continue to be needed for 10 percent of all patients, and that in half of these cases the information would require a new examination and tests within a 30-day window, the net costs of the current regulatory requirement would be 5 percent less than the preceding calculations. Supposing that such examination and testing information would still be required for 50 percent of all patients, the costs of the current requirement and hence the potential savings from its reform would fall much further. Absent more specific information, the estimates of potential costs and savings in Table 14 are suggestive but not robust until or unless improved through public comment and additional information. In our summary estimates, we have assumed a range of savings from zero to 50 percent, with a midpoint of 25 percent.
As support for the 50 percent upper bound, we note that Chen CL, Lin GA, Bardach NS, Clay TH, Boscardin WJ, Gelb AW, Maze M, Gropper MA and Dudley RA, Preoperative Medical Testing in Medicare Patients Undergoing Cataract Surgery, New England Journal of Medicine 372:1530-1538, April 16, 2015, find that approximately 53 percent of Medicare cataract patients undergo pre-operative testing, none of which is mandated by CMS regulation. If these patients' physicians are cautious enough to currently pursue more preoperative activity (testing, H&P, etc.) than what is required, or state or hospital rules are driving physician behavior beyond what Medicare necessitates, then there is little reason to believe that that behavior will change with the finalization of this rule. Given that other procedures tend to be more invasive than cataract surgery, pre-operative caution on the part of physicians is likely to be even greater in the non-cataract context. Indeed, Benarroch-Gampel J, Sheffield KM, Duncan CB, Brown KM, Han Y, Townsend CM and Riall TS, Preoperative Laboratory Testing in Patients Undergoing Elective, Low-Risk Ambulatory Surgery, Annals of Surgery 256(3):518-528, September 2012, and Fischer JP, Shang EK, Nelson JA, Wu LC, Serletti JM and Kovach SJ, Patterns of Preoperative Laboratory Testing in Patients Undergoing Plastic Surgery Procedures, Aesthetic Surgery Journal 1(1):133-141, January 2014, find that almost two-thirds of hernia procedures are preceded by testing, as are 62 percent of ambulatory plastic surgeries. This leaves an upper bound of 33 to 38 percent of non-cataract outpatient surgery H&P costs that could reasonably be expected to be avoided as a result of this rulemaking. In order to more successfully tailor the upper bound of potential cost savings to H&P activity—rather than just extrapolating from testing behavior—we request comment on the possibility of building on Chen et al.'s data and methodology to estimate the increased frequency of within-30-day office visits (presumed to be H&P) when ophthalmologist visits are at least 31 days prior to surgery relative to when ophthalmologist visits are no more than 30 days prior.
As noted in the medical literature previously discussed, Chung F, Yuan H, Yin L, Vairavanathan S, and Wong DT. Elimination of preoperative testing in ambulatory surgery. Anesth Analg. 2009 Feb, 108(s):467-75, there are no known consequential medical benefits from the testing often performed in association with the current regulatory requirements. This study covered hernia patients but similar results have been found in studies of cataract surgery. Accordingly, eliminating the testing could in theory produce very substantial annual ASC cost savings with no offsetting medical cost increases or harm to patients. H&P itself, however, is distinct from testing, and literature indicating that testing is wasteful does not necessarily speak to the importance of H&P. Therefore, if H&P is avoided, rather than more thoroughly integrated into same-day presurgical assessments, there could be adverse consequences to patients; these impacts have not been quantified.
As discussed in “Provisions of the Proposed Regulations,” section II.D. 2. of this proposed rule, there is a similar regulatory requirement for hospital outpatient surgery. Based on the substantial similarity between these two service settings, we also propose to eliminate these requirements for such surgery. Although we do not have detailed data for hospital outpatient surgery, it is widely agree to be roughly equal in size and composition to ASC surgery, though spending is higher because a higher payment schedule is used by some insurers, including Medicare, for most hospital outpatient surgery. Regardless, estimates should be based on economic costs, not any particular payment schedules. Accordingly, potential total annual savings, and hence benefits, for both settings taken together could be as much as $1.7 billion. This would depend on whether hospital-based outpatient
If, after ASCs and hospitals make policy decisions on which types of outpatient/ambulatory surgery patients would require a comprehensive H&P, it is found that only 50 percent of current costs were continued, potential total annual savings, and hence benefits, for both settings taken together could be as much as $908 million, assuming that hospital-based outpatient surgery H&P policy decisions parallel those of independent ASCs. Alternatively, if 75 percent of current costs were continued, potential savings would be only about $454 million annually. While the literature shows that we can be reasonably certain that for some procedures, such as cataract surgery, few or possibly even no costs would be self-imposed, there may be other procedures where ensuing policy decisions would retain all current history and physical requirements, though likely removing the strict 30-day rule. Because of the proposed requirements, and other uncertainties, the potential savings from lifting the current requirements encompass at least this broad range and quite possibly more. Because there is great uncertainty in these estimates we have decided not to present a predetermined figure in this proposed rule. Instead, we are requesting public comments on all the parameters of our estimates to inform the estimates we will make in the final rule. We welcome information on likely decisions in both ASC and hospital outpatient settings, and if possible for the most common procedures shown in Table 13 and for the likelihood and cost saving effects for procedure and patient categories where the facility chooses to retain an external H&P requirement, but extends the time window to a year or some other period that is far longer than 30 days.
We assume that the one-time costs of developing such policies for hospital outpatient surgery in 5,031 Medicare-participating hospitals would be the same in the aggregate, though the mix of personnel used would be somewhat different and the cost at free-standing hospitals would likely be several times higher (for example, for involvement of the governing body and legal review). About 3,200 of these hospitals are in multi-hospital systems that would, however, reap economies of scale, and about 574 are psychiatric hospitals that we assume rarely perform surgery. In total, we estimate that, first year savings for both types of facilities would be $38 million less, regardless of the replacement rules that each facility imposed on itself.
There are possible alternatives, including limiting the regulatory reform to the lowest risk procedures, which would probably mean almost all procedures, excluding certain procedures from the regulatory reform, exempting ASCs, but not hospital outpatient departments, changing the 30-day requirement to something much longer in duration such as 6 months or a year, and likely others. Absent contrary evidence, however, we believe that relying on physician and facility judgment maximizes benefits and presents no consequential costs.
We welcome comments on these estimates and on both the proposal and any alternatives, and particularly welcome any evidence-based information that would inform both our ability to provide cost savings estimates and a policy choice between either the proposed reform or an alternative.
As of May 2017 there are 4,602 Medicare participating hospices. We proposed to revise the hospice CoPs in order to reduce unnecessary duplications and streamline processes in order to reduce hospice compliance burden while maintaining minimum standards for patient safety and care.
At § 418.76(a) we propose to defer to State training and competency requirements, where they exist, for hospice aides. Deferring to state requirements would streamline the hiring process because hospices would not have to verify that a job candidate's qualifications meet or exceed the Federal standard in addition to verifying that the candidate meets State requirements.
According to the BLS, 408,920 aides are currently employed in “home care”. The term “home care” encompasses both home health agency and hospice employers. There are 12,624 HHAs and 4,602 hospices, meaning that hospices represent 27 percent of the “home care” employer market. Thus, we conclude that hospices employ 110,408 aides (27 percent of all aide positions in “home care”). Based on an informal survey conducted by the largest hospice industry association, 76 percent of
At § 418.106(a) we propose to delete the requirement that a hospice must ensure that the interdisciplinary group confers with an individual with education and training in drug management as defined in hospice policies and procedures and State law, who is an employee of or under contract with the hospice to ensure that drugs and biologicals meet each patient's needs. Not requiring the specific pharmacy advisement function would allow for more streamlined interdisciplinary group meetings. We assume that 25 percent of hospices currently use their own staff (employee or contract) for this function, and that this staff member is typically the nurse member of the interdisciplinary group. The nurse member of the interdisciplinary group is also required by § 418.56(a); therefore we believe that removing this requirement will not result in removing the expertise from the group. Rather, we believe that removing this requirement will remove the formulaic approach to interdisciplinary discussions whereby the group allots time in each meeting specifically for this discussion in order to assure regulatory compliance. In the absence of regulation, the interdisciplinary group would have the authority to decide whether the discussion is pertinent for a given patient and the information can be woven into the discussion at large. This approach has the potential to reduce the overall group discussion time, particularly for the 3 members of the interdisciplinary group that are not charged with being the pharmacology expert. Based on 1.6 million hospice patients and an assumed 3 interdisciplinary group meetings per patient, there are a total of 4,800,000 interdisciplinary group meetings per year. We assume that each interdisciplinary group meeting includes 2 minutes of time specifically related to discussing the results of the pharmacy advisement service for purposes of complying with the regulation, or 160,000 hours per year nationwide. At a cost of $299 per hour ($198 physician + $53 social worker + $48 pastoral counselor), we estimate that removing this requirement would save $47,840,000 annually.
Additionally, we believe that this change would reduce the specialist nursing time spent specifically on advisement services. We believe that moving away from a regulatory compliance “check box” approach would allow the specialist nurse to incorporate medication management more seamlessly into regular clinical practice. The 2008 Hospice CoP final rule (73 FR 32088) estimated a 1 hour burden per patient for expert pharmacy services (30 minute initial advisement per patient + 2 15 minute update advisements) for a total cost of $69 per patient for all advisement services (updated to 2017 dollars). We estimate that this proposed change would reduce that time by 50 percent, to 30 minutes per patient, resulting in a $35 per patient savings. Based on the assumption that 25 percent of hospices use their own employee to perform this function, we estimate that this reduction would occur for 400,000 patients nationwide (25 percent of 1.6 million hospice patients), for a total annual savings of $14,000,000.
Together with the previously stated estimate, total savings would be $47,840,000 + $14 million = $61,840,000 annually.
We propose to revise the requirement at § 418.106(d) to allow hospices to provide information regarding safe medication use, storage, and disposal in a more understandable manner. Under the current requirements, hospices are required to provide patients and families with a copy of the hospice's policies and procedures, which are not written in layperson terms. The proposed change would alleviate the burden associated with addressing the confusion created by the policies and procedures document. Following the initial cost of $483,210 (described in section III.E. of this rule) for developing new, more easily understandable materials for patient education, we believe that hospices would realize a savings of 10 minutes per patient because it would require less hospice staff time to explain the more understandable material. Based on an assumed 10 minutes of saved nursing time per patient, and 1.6 million patients, hospices would save 266,667 hours. At a cost of $69 per hour, the total savings would be $18,400,023.
First year: $18,400,023 savings−$483,210 initial year cost = $17,916,813 net savings.
Annually thereafter: $18,400,023 savings.
At § 418.112(f) we propose to allow hospices and long term care facilities the additional flexibility to negotiate the format and schedule for orienting long term care facility staff regarding certain hospice-specific information. We believe that this would allow for innovation and streamlining, and reduce hospice compliance costs related to this requirement by 20 percent. For purposes of our analysis only, we assume that a typical hospice conducts 6 orientation sessions per year, and that each orientation requires 2 hours of time from a hospice nurse. At a cost of $69 per hour, a typical hospice would spend $828 each year to orient long term care facility staff. Assuming a 20 percent reduction in burden that can be achieved through innovation and streamlining, a typical hospice would save $166 a year, or $763,932 savings annually for all 4,602 hospices.
Taken together, these proposed reforms would generate annual savings of approximately $82.8 million ($47.8 million for reduced interdisciplinary group meeting time + $14 million for reduced specialty nursing time + $18 million for streamlined controlled drug education practices + $2.2 million for streamlined hospice aide qualification requirements + $0.8 million for streamlined facility staff orientation). We welcome public comment regarding these burden estimates, and additional regulatory reforms to reduce the burden of the hospice CoPs.
As of May 2017, there were 5,031 Medicare participating hospitals. We propose to revise the hospital CoPs in order to simplify some requirements and streamline processes in order to reduce burden associated with hospital compliance with the Medicare CoPs while maintaining minimum health and safety standards. The specific savings for each proposed change are described below.
At § 482.21, we propose to allow for multi-hospital systems using a system governing body, as allowed under the CoPs, and that is legally responsible for two or more separately certified member hospitals, to have a unified QAPI program for the member hospitals subject to the system governing body. This will afford hospitals flexibility and the ability to gain efficiencies and achieve significant progress in quality by sharing best practices among all hospitals subject to the system governing body. This would be similar to current allowances for system governing bodies and unified medical staffs.
While there are no current requirements that explicitly prohibit the sharing of best practices across a system, the current requirements for each hospital to have its own separate and distinct QAPI program and Infection Control program certainly have inhibited and stifled sharing of best practices and innovations among individual hospitals within a system as we point out in the preamble to this proposed rule, and which we support with our reference to the Health Research and Educational Trust, in partnership with the American Hospital Association March 2010 publication entitled, “A Guide to Achieving High Performance in Multi-Hospital Health Systems.” This publication, along with positive public comments regarding unified medical staffs that we discussed in the May 2014 final rule and to which we refer in this proposed rule, clearly point to multi-hospitals more efficiently and effectively collecting, disseminating, and sharing innovations, solutions, and best practices for patient care to each of its member hospitals through these unified patient care programs.
Approximately 3,200 of the 5,031 Medicare-participating hospitals participate in a hospital system (American Hospital Association (AHA),
We propose to remove the requirement for hospitals at § 482.22(d), which states that a hospital's medical staff should attempt to secure autopsies in all cases of unusual deaths and of medical-legal and educational interest. Because this requirement is redundant and more detailed, specific requirements regarding medical-legal investigative autopsies are required by individual state law, we do not anticipate that hospitals would accrue additional savings from this change. The benefit to hospitals from eliminating this requirement is realized through a reduction in burden from no longer having to comply with two similar requirements of the Federal government and the State government. Hospitals would instead be required to follow the more detailed, specific regulations of the state in which they are located.
At § 482.42, we propose to allow for multi-hospital systems using a system governing body as currently allowed under the CoPs, and that is legally responsible for two or more separately certified member hospitals, to have a unified infection control program for those member hospitals subject to the system governing body. This would allow hospitals flexibility and the ability to gain efficiencies and achieve significant progress in infection prevention and control. This would also be similar to current allowances for system governing bodies and unified medical staffs.
The current regulatory burden for compliance with the Infection Control program requirement is approximately $191 million annually for all hospitals or $38,000 per hospital. If we were to allow a unified Infection Control program for multi-hospital systems, this would remove 3,200 hospitals from the total 5,031 (replaced by the 424 multi-hospital systems) for a total of 2,255 hospitals/multi-hospital systems that would still need to comply. The new regulatory burden would be a total of approximately $86 million annually (2,255 × $38,000), for an annual total savings of approximately $105 million. We welcome comments on the quantitative and non-quantitative portions of the preceding discussion and seek any empirical evidence that would improve the accuracy and thoroughness of the relevant benefits estimation. At §§ 482.58(b)(1) and 485.645(d)(1) (cross-referenced long-term care requirement at § 483.10(f)(9)) we propose to remove the requirement for hospital and CAH swing-bed providers to provide the right for patients to choose to or refuse to perform services for the facility and if they so choose, (a) document in the resident's plan of care, (b) noting whether the services are voluntary or paid and (c) provide wages for the work being performed given the location quality, and quantity of work requiring comparable skills. We discuss the economic impact for this provision in the ICR section of this rule, which is estimated to be $32 million.
At § 482.58(b)(4) (and § 485.645(d)(4)) (cross-referenced long-term care requirement at § 483.24(c)), we propose to remove the requirement for hospital and CAH swing-bed providers to provide an ongoing activity program that is directed by a qualified therapeutic recreation specialist or an activities professional who meets certain requirements as listed at § 483.24(c)(2). We discuss the economic impact for this provision in the ICR section of this rule, which is estimated to be $81 million.
We propose to remove the requirement at §§ 482.58(b)(5) and 485.645(d)(5) (cross-referenced long-term care requirement at § 483.70(p)) for hospital and CAH swing-bed providers to employ a qualified social worker on a full-time basis if the facility has more than 120 beds. Given that this provision is not applicable to either provider type due to the regulatory requirements for each, it does not impose a burden upon hospitals and as such, its removal would not result in a savings of burden hours or dollars.
At §§ 482.58(b)(8) and 485.645(d)(8) (cross-referenced long-term care requirement at § 483.55(a)(1)) we propose to remove the requirement for hospital and CAH swing-bed providers to assist in obtaining routine and 24-hour emergency dental care to its residents. We discuss the economic impact for this provision in the ICR section of this rule, which is estimated to be $2.9 million for all hospital and CAH swing-bed providers.
At § 482.61(d), we propose to allow non-physician practitioners to document progress notes in accordance with State laws and scope of practice requirements. We discuss the economic impact for this provision in the ICR section, which is estimated at $54.7 million in savings for psychiatric hospitals.
There are approximately 750 Medicare approved transplant programs in the United States, of which 250 are kidney transplant programs. All Medicare approved transplant programs must be a part of a Medicare approved hospital, and many hospitals have several types of organ programs. Oversight of these programs occurs in two major ways: By the Organ Procurement and Transplantation Network (OPTN), which is a non-profit membership-based organization operated under a Federal contract administered by the Health Resources and Services Administration (HRSA), and by CMS under the CoPs. The current and long-term OPTN contractor is the United Network for Organ Sharing (UNOS), which performs many transplantation functions, including matching donated organs to waiting lists of patients who have failing organs, and reviewing the performance of transplant centers on a variety of criteria, including patient and organ survival. There is a third mechanism encouraging better transplant program performance, the SRTR (accessed at
For patients with most types of organ failure, a transplant is the only option for long-term survival. In the case of kidney failure, however, kidney dialysis is a viable medium-term and sometimes long-term option for most patients. On average these patients can survive a dozen or more years on dialysis; however, without a transplant, they suffer increasingly high morbidity and mortality rates. We provide Medicare coverage for such patients through the ESRD program. Under the ESRD program, patients receive dialysis treatment, usually three times a week, through machines that cleanse their blood in much the same way as healthy kidneys would do. Since its inception in 1973, more than one million patients have received treatment under this program. Kidney failure patients are unique in another way: Unlike most other organs, with the partial exception of some liver donations, it is possible for living individuals to donate “live” kidneys, whether the living donor is a relative or an unrelated altruistic donor. In the case of ESRD patients, the Medicare ESRD program serves almost all kidney failure patients, regardless of age, and these patients receive costly dialysis for a prolonged period of time. As is the case for all CoPs, our regulations for Medicare-approved organ transplant programs have the potential to protect all patients, not just Medicare beneficiaries.
As discussed earlier in this preamble, we have long regulated transplant programs, but put in place additional CoPs in the March 2007 final rule (72 FR 15198) in an effort to increase the quality of care by specifying minimal health and safety standards. In addition, outcome metrics (1 year graft and patient survival) were included in the regulation and mirrored the OPTN outcomes metrics as calculated by the SRTR. Over time, increased emphasis on organ and patient survival rates, as key metrics of transplant performance, created incentives for transplant programs to select organs most likely to survive after transplant without rejection, and to select recipients most likely to survive after the transplant. In particular, due to the increasing patient and organ survival rates over time, the 2007 standards have become increasingly stringent over time as an artifact of the performance calculation method established in the 2007 rule, an outcome that was never intended by CMS. In addition, the 2007 rule created performance standards that focused only on organ and patient survival rates for those who received a transplant, not on survival rates of patients awaiting transplant. We refer readers to a discussion of this problem in the following CMS compliance Guidelines that could only partially lighten this unintended regulatory burden at
There is extensive literature on these incentives and other phenomena in transplant medicine that strongly suggests some unintended consequences on organ utilization (decreased use of “marginal” organs in their patients) and de-selection of some patients who are slightly less likely to survive for an extended period post-transplant. These unintended consequences have been anecdotal and measuring the extent to which they have occurred is difficult. In addition to the studies previously cited in the preamble (Adler et al., Schold et al., Dolgin et al., Stewart et al., Husain et al.), other studies on this issue include Kasiske B, Salkowski N, Wey A, Israni A, and Snyder J, “Potential Implications of Recent and Proposed Changes in the Regulatory Oversight of Solid Organ Transplantation in the United States,”
For purposes of this analysis, one approach to estimating effects is to isolate the number of kidneys (and other organs) that have been discarded as a result of the March 2007 rule; indeed, a reasonable assumption would be that this proposed rule's rescission of the 2007 requirements would have an equal and opposite effect. A slide presentation by UNOS researcher Darren Stewart (2017; accessed at
Unfortunately, these and other studies have had to deal with other trends during the last two decades that greatly complicate measuring the independent effect of the 2007 rule. These include the increasing age of the donor pool and the attendant decline in some dimensions of organ quality, and the opposite effects of improved techniques for maintaining organ quality between the time of donation and the time of transplantion. As a result, the published studies using data on organ discards have had to use complicated multivariate statistical procedures in attempting to estimate the effects of the 2007 rule, and invariably conclude that their findings are subject to considerable uncertainty.
The preceding analysis focuses on discard rates as a tool that transplant programs can use to reduce risk of lower patient or organ survival rates, and hence risk of closure under the 2007 rule. A second tool that a transplant program can use to reduce its risk of lower overall patient survival rates is to remove patients who are slightly less likely to survive from its waiting list, most commonly by making a judgmental decision that the patient is “too sick for transplantation.” Programs that are on the margin of receiving regulatory sanctions, or that have received such sanctions already, are particularly likely to exercise such judgments to reduce regulatory risk. Several studies have estimated specific numbers of transplant reductions due to the 2007 rule by comparing the number of patients removed from the waiting list at programs that have received regulatory sanctions to those that have not. To provide a baseline, these studies make the conservative assumption that those programs with zero sanctions have not removed any patients from their transplant waiting list in order to avoid sanctions. For kidneys, one study estimated that in the seven year period from 2007 to 2014, the lower performing programs removed from waiting lists over 2500 patients more than would have been expected absent sanctions, an average of over 350 per year (J.D. Schold et al., “Association of Candidate Removals From the Kidney Transplant Waiting List and Center Performance Oversight,” American Journal of Transplantation 2016, 1276-1284). The implications, for the present time, of wait list changes initiated in 2007 is unclear. Increased mortality in 2007 among the very sick patients who were dropped from the wait list would have freed up organs for 2007's moderately sick patients; these patients otherwise would have declined in health so as to be the very sick population in 2008. Thus the absolute level of health in 2008 would have been relatively good, in which case the phenomenon of patients being dropped from the wait list might not have perpetuated into the future, leaving little or no scope for benefits to be achieved now as a result of the proposed CoP revision. (We note that one year, from 2007 to 2008, may be an exaggeration as to the short-term nature of this wait list-related effect, but a somewhat longer tapering period could still have reached completion now, more than a decade after the implementation of the 2007 CoP, thus leaving little scope for benefits.) On the other hand, if the sickest patients in 2008 were dropped based on their relative health levels—in spite of their improved absolute health relative to the sickest patients in 2007—there would be potential wait list-related benefits from revising this CoP at the present time. The benefits of shifting transplants to the sickest patients from relatively less sick patients have not been quantified, but because the harm to the less sick patients would need to be netted off the benefit to the sickest patients, the per-transplant magnitude would be much lower than the per-transplant benefits of avoided organ discards.
Another quantitative study of kidney transplant effects used a similar methodology and estimated that as a result of the 2007 rule, in 2011 sanctioned programs performed 766 fewer kidney transplants than would otherwise have been the case (Sarah L. White et al., “Patient Selection and Volume in the Era Surrounding Implementation of Medicare Conditions of Participation for Transplant Programs,” Health Services Research, April 2015, 330-350). White et al.'s finding of reduced transplant volumes at particular kidney transplant centers does not necessarily indicate decreased transplant volumes overall, with the authors stating that their aggregate results “do not indicate that the introduction of the [2007] CoPs has systematically reduced opportunities for marginal candidates or that there has been a systematic shift away from utilization of higher risk deceased donor kidneys.” In other words, regulatory sanctions could have triggered behavioral responses by some patients, some transplant surgeons, or some health insurance plans to shift patients away from these centers (many insurers restrict coverage through “centers of excellence” programs). Schold et al. (2013) find additional support for this phenomenon, describing their empirical result as follows: “Among 203 [adult kidney transplant] centers, 46 (23%) were low performing (LP) . . . Among LP centers, there was a mean decline in transplant volume of 22.4 cases compared to a mean increase of 7.8 transplants among other centers.” The estimated decrease per low-performing transplant center is roughly three times the increase per other center, but there are also roughly three times as many other centers as low-performing centers; as such, the most straightforward interpretation of this paper is that the same number of transplants is being concentrated in a smaller number of transplant centers. This outcome could still have real impacts, such as changes in travel time for patients, but although these impacts are valid for inclusion in a regulatory impact assessment, they would be much smaller in magnitude than the longevity benefits emphasized elsewhere in this analysis.
A feature common to most of these studies that is that they use data that are already several years old when the study is published, both because of the usual publishing lag and because performance data such as one-year survival rates necessarily make transplant program results less timely. None of these studies covers the last two or three years of transplant program performance. As a result, none of these studies has been able to use actual data to assess the effects of the May 13, 2016 CMS changes that slightly reduced the performance level for finding a “condition-level” violation that threaten's program closure. For recent reviews of potential effects of those changes see B.L. Kasiske et al., “Potential Implications of Recent and
There are several studies that make similar estimates for liver transplant programs (for example, L.D. Buccini, et al., “Association Between Liver Transplant Center Performance Evaluations and Transplant Volume,” American Journal of Transplantation 2014, 2097-2105). This study found a large difference in transplant volume between programs rated as lower performing by the SRTR (average decrease of 39.9 transplants from 2007 to 2012) and those not receiving adverse SRTR ratings (average increase of 9.3 transplants over the same period). The 27 lower performing centers thus reduced their total number of liver transplants by over 1,000, and compared to the higher performing centers the decrease was even larger. This study did not, however, tie its estimates to the performance standards in the 2007 rule (which are similar but not identical to SRTR standards), to sanctions under that rule, or to specific center decisions, such as removing candidates from the wait list. Hence, while it certainly contributes to the body of scholarship indicating that since 2007 transplants have been performed in a more concentrated set of programs, it does not appear to provide direct estimates of the quantitative effects of the 2007 rule on overall numbers of liver transplants.
Taking into account all the various uncertainties involved in these studies, we do not believe that we can estimate the effects of the 2007 rule on numbers of transplantations for any organ other than kidneys, and that even for kidneys there is no clear central estimate of likely quantitative effects. The wide variation in published results, and the disclaimers as to the various uncertainties involved, make a precise as well as reliable estimate all but impossible and would render arbitrary any non-zero lower bound estimate of health and longevity impacts. (As noted above, however, even in the absence of health and longevity effects, there may be other benefits, such as reduced travel costs, if the proposed rule reduces concentration of transplants in a smaller number of facilities.) Therefore, we have shown the effects of the proposed change as “not quantified.” This is not unusual in Regulatory Impact Analyses that address complex phenomena that cannot be measured directly, or whose effects are intertwined with other changing circumstances. That said, we welcome any additional information that might allow a quantitative estimate in the final rule.
Every transplant quality organ that is used for transplantation rather than discarded has a very high probability of substantially extending the life of the recipient. There is a particularly extensive literature on life expectancy before and after transplant, quality of life, and cost savings for kidney patients. A literature synthesis on “The Cost-Effectiveness of Renal Transplantation,” by Elbert S. Huang, Nidhi Thakur, and David O. Meltzer, in Sally Satel,
Even without a robust aggregate estimate of likely increases in organ utilization as a result of this proposed regulatory change, the potential benefits are very substantial. For each new kidney transplantation, there would be an average of 10 additional life years per transplant patient compared to those on dialysis (see Wolfe A. et al., “Comparisons of Mortality in All Patients on Dialysis, Patients on Dialysis Awaiting Transplantation, and Recipients of a First Cadaveric Transplant,” NEJM, 1999, 341:1725-30; accessed at
Those HHS guidelines also explain in some detail the concept of quality adjusted life years. The key point to understand is that these are research-based estimates of the value that people
An alternative and more sophisticated analysis would take into account that the life-extending effect of a kidney transplant is not its first effect, but typically follows a number of years off dialysis, until the organ fails and the patient returns to dialysis or is retransplanted. Such an analysis can be found in a recent study by P.J. Held et al., “A Cost-Benefit Analysis of Government Compensation of Kidney Donors,” American Journal of Transplantation, 2016, pages 877-885 (plus 65 pages of supplementary details explaining all assumptions, data sources, and calculations). The largest differences between the base case estimated in that study and the preceding estimates is that this RIA uses the considerably higher value of a statistical year of life under HHS guidelines, and this RIA uses the full value of a statistical life year without a “quality” adjustment for the added years of life (we use QALYs only for the improved quality of life during years that would otherwise be on kidney dialysis). Under such an estimation approach, potential life-extending benefits could be somewhat larger. For example, if the proposed reform increased the number of life-extending kidney transplants by only 100 a year, and the benefits of both additional life years and QALY gains were estimated at $5.1 million per patient, its total annual benefits for kidney patients would be approximately $510 million a year (100 × $5.1 million).
There are additional benefits from kidney transplantation. As previously discussed, kidney transplants do reduce medical costs, with “breakeven” after about 5 years and net savings of several hundred thousand dollars per patient. Other organ transplants create lesser or no medical savings because the alternative is not dialysis. Clearly, however, these kidney transplant savings are small in relation to the life-extending benefits. We have not estimated medical savings or costs for kidneys or other organs in this RIA because any such estimates would depend on the number of additional transplants that we have not estimated.
We welcome comments on the quantitative and non-quantitative portions of the preceding discussion and seek any empirical evidence that would allow robust estimates of benefits, and in particular robust quantitative estimates of the number of patients deprived of transplantation as a result of the 2007 rule, as currently implemented to reflect the 2016 guidance, for each organ type. We also welcome comments on whether we have accurately and reasonably summarized the research evidence on the effects of the 2007 rules, particularly in the light of the many other factors influencing transplantation trends and performance.
We note that life-extending estimates are averages across patients who vary widely in age, medical condition, and life expectancy, as well as type of organ failure. For example, the sickest patients typically have very low life expectancies without transplant, and hence stand to gain the most years of life from a transplant. Partly offsetting this, these same patients, on average, have slightly lower survival rates post-transplant. Organ and patient survival issues are complex and dealt with by detailed policies and procedures developed and used by the transplant community under the auspices of the OPTN. These policies are reviewed and revised frequently based on actual experience and changing technology—over time the success rate from previously marginal organs, and in older patients, have both increased substantially. For purposes of this analysis, the proper measure is the average gain across all patients who would receive transplants as a result of eliminating the 2007 rule, net of these other factors.
There could be potential offsets to these calculated and uncalculated benefits and cost reductions. However, the particular regulatory requirements we propose to remove are unlikely to drive any further significant increases in graft and patient survival. For renal transplants, the expected 1-year graft and patient survival rates are already at 95 percent or better. Transplant program outcomes will continue to be monitored by the OPTN and programs that are not in compliance with the OPTN outcomes are referred to their Membership and Professional Standards Committee for quality improvement activities. The SRTR also publishes detailed data on transplant program performance that allows patients and their physicians to compare transplant programs and this transparency creates pressures to maintain and improve survival rates in order to attract these patients.
The current regulatory requirements for transplant centers, as discussed in section II.E “Transplant Centers” of this proposed rule, have created both positive and adverse incentives for transplant programs, with unanticipated side effects on both utilization of donated organs and the ability of the highest risk patients to obtain transplants. We expect the proposed change to provide substantial net benefits, particularly since other regulatory and informational incentives remain in place.
We welcome comments on this analysis as well as information that would enable a more robust quantitative analysis of the impacts of this change and on any alternative reforms that might provide even higher benefits.
As of May 2017 there are 12,624 HHAs that participate in Medicare and Medicaid. In the January 2017 HHA CoP final rule (82 FR 4149) we estimated that compliance with the requirements at § 484.50(a)(3) related to providing oral notice of all rights to each patient would impose a burden of 5 minutes per patient, or 330,246 hours of burden nationwide at a cost of $80,030,370, annually. The cost estimate was based on a $63 per hour estimate for the services of a RN as derived from the BLS Occupational Handbook, 2014-2015 edition, including a 100 percent benefit and overhead package. Adjusted to reflect more updated salary information, as described previously, we estimate that compliance with this provision would impose a $91,786,974 burden, based on a RN earning $69 per hour.
We propose to revise the verbal notification requirements to limit them to those that are required by section 1891 of the Act. Limiting the amount of information that is required to be provided orally will reduce the time per patient that is required to comply with the revised requirement. For purposes of this analysis only, we assume that providing oral notice regarding financial liability only will require 2 minutes per patient, reducing burden by 60 percent. Based on this assumption, this proposed change would reduce the burden of the patient rights notification requirement by 198,148 hours (330,246 hours originally estimated × 0.6) and $55,072,184 ($91,786,974 burden as updated to reflect more recent salary estimates × 0.6).
We also propose two changes that do not have a savings estimate. First, we propose to eliminate the requirement at § 484.80(h)(3) that the HHA conduct a full competency evaluation of deficient home health aides, and replace it with a requirement to retrain the aide regarding the identified deficient skill(s) and require the aide to complete a competency evaluation related to those
Second, we propose to remove the requirement at § 484.110(e) related to providing a requested copy of the clinical record at the next home visit, while retaining the requirement to provide the record within 4 business days. As stated in the January 2017 HHA CoP final rule (82 FR 4568 and 4575), we believe that providing such information to patients is a usual and customary practice that does not impose a burden upon HHAs. As such, removing the “next home visit” timeframe requirement would not result in a savings of burden hours or dollars.
We welcome public comment regarding these burden estimates, and additional regulatory reforms to reduce the burden of the HHA CoPs.
We propose to remove the requirement at § 485.627(b)(1) for CAHs to disclose to CMS its owners or those with a controlling interest in the CAH or any subcontractor in which the CAH directly or indirectly ha a 5 percent or more ownership interest in accordance with 42 CFR part 420, subpart C. We discuss the economic impact of this provision in the ICR section, which is estimated at $141,000 total for all CAHs. We discussed the burden reduction for our proposed revision of the “patient care policies” requirements imposed on CAHs in the ICR section of this rule, which is estimated at $2.5 million.
We discussed the burden reduction for our proposed revision of the “utilization review plan” requirements imposed on CORFs in the ICR section of this rule, which is estimated at $309,072.
We discussed the burden reduction for our proposed revision of § 485.914(d)(1) “update of the comprehensive assessment” requirements imposed on CMHCs in the ICR section, which is an estimated savings of $152,464.
At § 486.104 we propose to revise the portable x-ray CfCs to focus on the qualifications of the technologist performing the diagnostic test. As of May 2017 there were approximately 500 Medicare-participating portable x-ray suppliers employing an estimated 5,000 portable x-ray technologists. Hiring limited x-ray technologists or those with State licensure would allow portable x-ray suppliers to fill vacant positions at a lower hourly cost. Assuming a 10 percent annual turnover rate, all technologists could be hired at the lower salary over a period of 10 years. Limited x-ray technologists can be hired for approximately $30 an hour ($62,400 per year), whereas, according to the BLS, x-ray technologists with advanced certification (ARRT) are hired at a rate of approximately $60 dollars per hour ($124,800 per year). This creates a savings opportunity of $30 per hour, or $62,400 per year, per technologist position. Based on an assumed 10 percent turnover rate, or 500 positions filled in any given year, this change would create a savings of $31,200,000 savings in the first year. We believe that these savings would be increased every year as more positions are filled at the lower salary rate.
We welcome public comment regarding these burden estimates, and additional regulatory reforms to reduce the burden of the portable x-ray CfCs.
We discussed the burden reduction for our proposed revision of § 491.9(b)(4) “review of patient care policies” requirements imposed on RHCs and FQHCs in the ICR section, which is an estimated savings of $6.8 million. In addition, the burden reduction for our proposed revision of § 491.11(a) “program evaluation” requirements imposed on RHCs and FQHCs in the ICR section of this rule, which is an estimated savings of $9.4 million.
This proposed rule revises the emergency preparedness requirements for Medicare and Medicaid participating providers and suppliers, as discussed in detail in section II.M of this proposed rule. The proposed modifications to the emergency preparedness requirements either simplify the requirements, eliminate duplicative requirements, or reduce the frequency in which providers would need to comply with the emergency preparedness requirements. We estimate that the proposed changes to the emergency preparedness requirements would accrue an annual cost savings of $155 million in total. The potential, estimated cost savings for each revised emergency preparedness requirement is outlined in detail below. The methodology used to calculate the economic impact and the costs associated with the proposed changes to the emergency preparedness requirements is the same methodology used to calculate the economic impact in the Emergency Preparedness final rule (81 FR 63860).
At § 482.15(a), (b), (c), and (d) for hospitals and parallel regulatory citations for other facilities, we propose to allow providers to review their program at least every 2 years. We discuss the economic impact for this requirement in the ICR section of this rule, which represents $94,312,719 in savings.
At § 482.15(a)(4) for hospitals, and other parallel citations for the facilities mentioned in section II.J.2 of this proposed rule, we propose to eliminate the requirement that facilities document efforts to contact local, tribal, regional, State, and Federal emergency preparedness officials and that facilities document participation in collaborative and cooperative planning efforts. We discuss the economic impact for this requirement in the ICR section of this rule, which represents $7,179,117 in savings.
At § 482.15(d)(1)(ii) for hospitals, and other parallel citations for other facilities mentioned in section II.J.2 of this proposed rule, we propose to require that facilities provide training biennially, or every 2 years, after facilities conduct initial training on their emergency program. In addition, we propose to require additional training when the emergency plan is significantly updated. We discuss the economic impact for this requirement in the ICR section of this rule, which represents $33,267,864 in savings. Finally, at § 482.15(d)(2), we propose to require that providers of inpatient services mentioned in section II.J.2 of this proposed rule conduct two testing exercises annually, one of which may be an exercise of their choice that must be either a community-based full-scale exercise (if available), an individual facility-based functional exercise, a drill, a tabletop exercise or workshop that includes a group discussion led by a facilitator. We propose to require that providers of outpatient services mentioned in section II.J.2 of this proposed rule conduct one testing exercise annually which must be either a community-based full-scale exercise (if available) or an individual facility-based functional exercise every other year, and in the opposite years, may be either a community-based full-scale exercise (if available), a facility-based functional exercise, a drill, or a tabletop exercise or workshop that includes a group discussion led by a facilitator. We
We estimate a total impact savings of $10,997,373 for this proposed change. With an estimated ICR savings of $9,117,425, we estimate that the total economic impact of this rule for the affected providers will be $20,114,798. We list a summary of the calculation for the impact savings accrued by removing this requirement for each facility in Table 15, based on facility numbers available as of May 2017.
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All of the changes presented above will necessarily have to be read, and understood, and implemented by affected providers. This will create one-time costs even though the underlying change reduces burden. In most cases these costs will be very low, and may be as simple as observing that a particular procedure will need only to be performed once rather than twice a year, and changing the schedule accordingly. In some cases, the facility will need to adjust in response to multiple burden reduction changes. In still other cases, time will have to be spent deciding how to change existing policy. For example, as discussed previously, ASCs and hospital outpatient facilities will need to decide whether and in what circumstances medical histories and physical examinations will be required or encouraged as a matter of policy. Rather than attempt to estimate these situational variables in detail for each facility type, we believe it possible to make reasonable overall estimates of these one-time costs, recognizing that there will be considerable variations among provider types and among individual providers.
In total, there are about 122 thousand affected entities, as shown in the Table 17 that follows. We assume that on average there will be 1 hour of time spent by a lawyer, 2 hours of time by an administrator or health services manager, and 2 hours of time by other staff (we assume registered nurses or equivalent in wage costs) of each affected provider to understand the regulatory change(s) and make the appropriate changes in procedures. We further estimate that for one tenth of these providers, 2 hours of physician time will be needed to consider changes in facility policy. Average hourly costs for these professions, with wage rates doubled to account for fringe benefits and overhead costs, are $134 for lawyers, $105 for managers, $70 for registered nurses, and $198 for physicians. These numbers are from BLS statistics for 2016, at
The estimated costs for an average provider would therefore be 1 hour at $134 and in total for the lawyers, 2 hours at $105 or $210 in total for the managers, 2 hours at $69 or $138 in total for the other staff, and two-tenths of 1
The RFA requires agencies to analyze options for regulatory relief of small entities, if a rule has a significant impact on a substantial number of small entities. For purposes of the RFA, we estimate that almost all health care providers regulated by CMS are small entities as that term is used in the RFA (including small businesses, nonprofit organizations, and small governmental jurisdictions). The great majority of hospitals and most other health care providers and suppliers are small entities, either by being nonprofit organizations or by meeting the SBA definition of a small business (having revenues of less than $7.5 million to $38.5 million in any 1 year, varying by type of provider and highest for hospitals). Accordingly, almost all of the savings that this proposed rule would create will benefit small entities. We note that individual persons are not small entities for purposes of the RFA, and hence the life-extending transplantation benefits of the proposed rule are not relevant to the RFA.
The RFA requires that a Regulatory Flexibility Analysis (RFA) be prepared if a proposed rule would have a “significant impact on a substantial number” of such entities. HHS interprets the statute as mandating this analysis only the impact is adverse, though there are differing interpretations. Regardless, there is no question that this proposed rule would affect a “substantial number” of small entities. As shown in Table 17, the total number of affected entities will be about 122,000, including those affected by more than one provision. The rule of thumb used by HHS for determining whether an impact is “significant” is an effect of 3 percent or more of annual revenues. These savings do not approach that threshold. Hospitals account for about one-third of all health care spending and even if all these savings accrued to hospitals this threshold would not be approached. Therefore, the Secretary has determined that this proposed rule will not have a significant economic impact on a substantial number of small entities.
In addition, section 1102(b) of the Social Security Act requires us to prepare a regulatory impact analysis if a rule may have a significant impact on the operations of a substantial number of small rural hospitals. This analysis must conform to the provisions of section 603 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 and has fewer than 100 beds. For the reasons previously given, the Secretary has determined that this proposed rule will not have a significant impact on the operations of a substantial number of small rural hospitals.
Section 202 of the Unfunded Mandates Reform Act of 1995 (UMRA) also requires that agencies assess anticipated costs and benefits before issuing any rule whose mandates require spending in any 1 year of $100 million in 1995 dollars, updated annually for inflation. In 2018, that threshold is approximately $148 million. This proposed rule contains no mandates that will impose spending costs on State, local, or tribal governments, or on the private sector. Indeed, it substantially reduces existing private sector mandates.
Executive Order 13132 establishes certain requirements that an agency must meet when it promulgates 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 proposed rule imposes no such requirements. Importantly, it would remove Federal requirements setting qualification standards for hospice aides. Setting qualifications for health care workers is traditionally a State function, and this change would therefore remove an infringement on State prerogatives.
Most of the individual proposals addressed in the preceding analysis involve reducing burdensome costs on facilities, health care professionals, and patients. Most of those reductions save time and effort currently performed on tasks that we propose to eliminate or reform and those reductions will result ultimately in reduced medical care costs in these facilities, some of which will result in further effects on public and private insurance costs. In this regard, it is important to emphasize that the CoPs and CfCs generally apply to all patients served by a Medicare and/or Medicaid participating provider or supplier, not just Medicare or Medicaid patients, and
In total, we estimate that the approximately 40 specific provisions summarized in Tables 1 and 2 that are not related to reductions in pre-operative physical examinations and tests in outpatient surgery, or to transplantation, will save facilities and other providers, insurers, and patients about $669 million annually. The initial savings will accrue primarily to providers. How much of these savings will flow to insurers and patients depends primarily on the payment and reimbursement mechanisms in place for each affected entity for those particular costs. According to the National Health Expenditure Accounts, approximate payer shares in 2016 were 11 percent for consumer out of pocket, 35 percent for private health insurance, 21 percent for Medicare, 18 percent for Medicaid, and 15 percent for other public and private payers such as the Department of Veteran Affairs and the Department of Defense. We would expect savings to approximate these shares. Ultimately, all costs are paid by workers and taxpayers who pay for all health care directly or indirectly, quite apart from immediate cost subsidies or cost sharing.
Two provisions directly reduce Medicare and other insurance costs. Eliminating unnecessary patient history and physical examinations and medical tests for procedures (such as cataract surgery) performed in ASCs and in hospital outpatient surgery will disproportionately reduce Medicare costs, since use of these services rises with age. Additional transplantation of kidneys will reduce Medicare's ESRD costs, partially offset by increased transplantation costs. Because of the difficulty in finding evidence of the volume of such savings, we cannot estimate the likely effects on Medicare spending.
Most of the facility and provider savings will accrue to Medicare and other insurers over time as payment rate increases are slightly reduced, and the remainder will accrue to other payers and to patients.
The following table shows our estimates of savings by major burden reduction category and by type of payer.
We discussed life-extending and life-saving benefits at length in the analysis of increases in transplantation. These result from removal of disincentives to transplant patients, or to use organs, where this could reduce success rates by a few percent and possibly trigger closure of transplant centers or programs under current rules. As previously explained, we do not have robust estimates. There are additional and substantial patient benefits likely to result from the cost-reducing reforms that we propose. Time not wasted by medical care providers or facilities on unnecessary tasks is time that can be used to focus on better care. While such effects could be measured in principal, there is little existing data on magnitudes of such effects. We do, however, welcome public comments on these or any other aspects of costs and benefits of the proposed rule.
From within the entire body of CoPs and CfCs, we selected what we believe to be the most viable candidates for reform as identified by stakeholders, by recent research, or by experts as unusually burdensome. This subset of the universe of standards is the focus of this proposed rule. For all of the proposed provisions, we considered not making these changes. Ultimately, we saw no good reasons not to propose these burden reducing changes.
We welcome comments on whether we properly selected the best candidates for change, and welcome suggestions for additional reform candidates from the entire body of CoPs and other regulatory provisions that fall directly on providers.
Our estimates of the effects of this regulation are subject to significant uncertainty. While the Department is confident that these reforms will provide flexibilities to facilities that will yield major cost savings, there are uncertainties about the magnitude of these effects. Despite these uncertainties, we are confident that the rule will yield substantial overall cost reductions and other benefits. In this analysis we have provided estimates to suggest the potential savings these reforms could achieve under certain assumptions. We appreciate that those assumptions are simplified, and that actual results could be substantially higher or lower. Although there is uncertainty concerning the magnitude of all of our estimates, we do not have the data to provide specific estimates for each reform proposed, as to the range of possibilities, or to estimate all categories of possible benefits, including health effects.
As required by OMB Circular A-4 (available at
While most provisions of the proposed rule have clearly predictable effects we do not in most cases have detailed empirical information on the precise magnitude of efforts involved (for example, time spent in meeting paperwork or other administrative tasks
Executive Order 13771, titled Reducing Regulation and Controlling Regulatory Costs, was issued on January 30, 2017 and requires that the costs associated with significant new regulations “shall, to the extent permitted by law, be offset by the elimination of existing costs associated with at least two prior regulations.” This proposed rule will, if finalized as proposed, be considered an E.O. 13771 deregulatory action. We estimate that this rule generates $1,051 million in annualized cost savings, discounted at 7 percent relative to year 2018, over a perpetual time horizon. This estimate is based on cost reductions starting at $1,123 million, and growing by $31 million annually due to salary savings from X-ray technician turnover, partially offset by one-time first-year implementation costs of $64 million, all in 2016 dollars. Details on the estimated cost savings from this rule can be found in the preceding analysis. We note that public comments and additional information may enable us to estimate considerably larger savings from reforming H & P requirements for ambulatory surgery or to narrow the uncertainty within the range of the preliminary estimates.
This proposed rule would substantially reduce existing regulatory requirements imposed on health care providers through the CoPs and related regulatory provisions that Medicare and Medicaid providers must meet. For some provisions, health benefits to patients will be substantial and direct. Other provisions will free up time and efforts of health care providers to focus on improving health care quality and service delivery. Although this proposed rule does not require an Initial Regulatory Flexibility Analysis, this regulatory impact analysis, together with the remainder of this preamble, meets the requirements for such an analysis. Furthermore, the analysis in this section of the preamble, together with the remainder of this preamble, provides a complete Regulatory Impact Analysis.
In accordance with the provisions of Executive Order 12866, this regulation was reviewed by the Office of Management and Budget.
Grant programs—health, Health insurance, Hospitals, Intergovernmental relations, Medicare, Reporting and recordkeeping requirements.
Health facilities, Health professions, Medicare, Reporting and recordkeeping requirements.
Health facilities, Hospice care, Medicare, Reporting and recordkeeping requirements.
Aged, Family planning, Grant programs-health, Infants and children, Medicaid, Penalties, reporting and recordkeeping requirements.
Aged, Health care, Health records, Medicaid, Medicare, Reporting and recordkeeping requirements.
Grant program—health, Hospitals, Medicaid, Medicare, Reporting and recordkeeping requirements.
Grant programs—health, Health facilities, Health professions, Health records, Medicaid, Medicare, Nursing home, Nutrition, Reporting and recordkeeping requirements, Safety.
Health facilities, Health professions, Medicare, Reporting and recordkeeping requirements.
Grant programs—health, Health facilities, Medicaid, Reporting and recordkeeping requirements.
Grant programs—health, Health facilities, Medicare, Reporting and recordkeeping requirements, X-rays.
Administrative practice and procedures, Health facilities, Health professions, Medicare, reporting and recordkeeping requirements.
Grant programs—health, Health facilities, Medicaid, Medicare,
Health facilities, Diseases, Medicare, Reporting and recordkeeping requirements.
For the reasons set forth in the preamble, the Centers for Medicare & Medicaid Services proposes to amend 42 CFR chapter IV as set forth below:
42 U.S.C. 1395b-3 and Secs. 1102 and 1871 of the Social Security Act (42 U.S.C. 1302 and 1395hh).
The revision reads as follows:
(a)
(1) Discharge instructions must be provided at the time of discharge to the patient or the patient's caregiver as necessary.
(2) If the patient assessment indicates a need for a discharge plan, the discharge plan must include instructions on post-RNHCI care to be used by the patient or the caregiver in the patient's home, as identified in the discharge plan.
(3) If the RNHCI's patient assessment does not indicate a need for a discharge plan, the beneficiary or his or her legal representative may request a discharge plan. In this case, the RNHCI must develop a discharge plan for the beneficiary.
The revisions and addition read as follows:
(a)
(4) Include a process for cooperation and collaboration with local, tribal, regional, State, and Federal emergency preparedness officials' efforts to maintain an integrated response during a disaster or emergency situation.
(b)
(c)
(d)
(1) * * *
(ii) Provide emergency preparedness training at least every 2 years.
(v) If the emergency preparedness policies and procedures are significantly updated, the RNHCI must conduct training on the updated policies and procedures.
Secs. 1102, 1138, and 1871 of the Social Security Act (42 U.S.C. 1302, 1320-8, and 1395hh) and section 371 of the Public Health Service Act (42 U.S.C. 273)).
(b) * * *
(2) Significant medical history and results of physical examination (as applicable).
(a)
(i) Include the timeframe for medical history and physical examination to be completed prior to surgery.
(ii) Address, but is not limited to, the following factors: Patient age, diagnosis, the type and number of procedures scheduled to be performed on the same surgery date, known comorbidities, and the planned anesthesia level.
(iii) Follow nationally recognized standards of practice and guidelines, and applicable State and local health and safety laws.
(2) Upon admission, each patient must have a pre-surgical assessment completed by a physician who will be performing the surgery or other qualified practitioner in accordance with applicable State health and safety laws, standards of practice, and ASC policy.
(3) The pre-surgical assessment must include documentation of any allergies to drugs and biologicals.
(4) The patient's medical history and physical examination (if any) must be placed in the patient's medical record prior to the surgical procedure.
The revisions and addition read as follows:
(a)
(4) Include a process for cooperation and collaboration with local, tribal, regional, State, and Federal emergency preparedness officials' efforts to maintain an integrated response during a disaster or emergency situation.
(b)
(c)
(d)
(1) * * *
(ii) Provide emergency preparedness training at least every 2 years.
(v) If the emergency preparedness policies and procedures are significantly updated, the ASC must conduct training on the updated policies and procedures.
(2)
(i) Participate in a full-scale exercise that is community-based or when a community-based exercise is not accessible, individual, a facility-based functional exercise every 2 years. If the ASC experiences an actual natural or man-made emergency that requires activation of the emergency plan, the ASC is exempt from engaging in its next required community-based or individual, facility-based functional exercise following the onset of the actual event.
(ii) Conduct an additional exercise at least every 2 years, opposite the year the full-scale or functional exercise under paragraph (d)(2)(i) of this section is conducted, that may include, but is not limited to the following:
(A) A second full-scale exercise that is community-based, or an individual, facility-based functional exercise; or
(B) A mock disaster drill; or
(C) A tabletop exercise or workshop that includes a group discussion led by a facilitator, using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan.
(iii) Analyze the ASC's response to and maintain documentation of all drills, tabletop exercises, and emergency events and revise the ASC's emergency plan, as needed.
Secs. 1102 and 1871 of the Social Security Act (42 U.S.C. 1302 and 1395hh).
(a) * * *
(1) * * *
(iv) A State licensure program.
The revision reads as follows:
(a) * * *
(2) [Reserved]
(e) * * *
(2) * * *
(i) Safe use and disposal of controlled drugs in the patient's home. The hospice must have written policies and procedures for the management, use, storage, and disposal of controlled drugs in the patient's home. At the time when controlled drugs are first ordered the hospice must:
(A) Provide information regarding the use, storage, and disposal of controlled drugs to the patient or patient representative and family in a format that is available on a continual basis;
(B) Discuss the information regarding the safe use, storage and disposal of controlled drugs with the patient or representative, and the family, in a language and manner that they understand to ensure that these parties are effectively educated; and
(C) Document in the patient's clinical record that the information was provided and discussed.
(c) * * *
(10) A delineation of responsibilities for assuring orientation of SNF/NF or ICF/IID staff furnishing care to hospice patients, to include information regarding the hospice philosophy; hospice policies and procedures regarding methods of comfort, pain control, and symptom management; principles about death, dying, and individual responses to death; patient rights; appropriate forms; and record keeping requirements.
The revisions and addition to read as follows:
(a)
(4) Include a process for cooperation and collaboration with local, tribal,
(b)
(c)
(d)
(1) * * *
(iii) Provide emergency preparedness training at least every 2 years.
(vi) If the emergency preparedness policies and procedures are significantly updated, the hospice must conduct training on the updated policies and procedures.
(2)
(i) Participate in a full-scale exercise that is community-based or when a community-based exercise is not accessible, an individual, facility-based functional exercise every 2 years. If the hospice experiences an actual natural or man-made emergency that requires activation of the emergency plan, the hospital is exempt from engaging in its next required full-scale community-based or individual, facility-based functional exercise following the onset of the actual event.
(ii) Conduct an additional exercise at least every 2 years, opposite the year the full-scale or functional exercise under paragraph (d)(2)(i) of this section is conducted, that may include, but is not limited to the following:
(A) A second full-scale exercise that is community-based or an individual, facility-based functional exercise; or
(B) A mock disaster drill; or
(C) A tabletop exercise or workshop that includes a group discussion led by a facilitator, using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan.
(3)
(i) Participate in a full-scale exercise that is community-based or when a community-based exercise is not accessible, an individual, facility-based functional exercise annually. If the hospice experiences an actual natural or man-made emergency that requires activation of the emergency plan, the hospice is exempt from engaging in its next required full-scale community-based or individual, facility-based functional exercise following the onset of the actual event.
(ii) Conduct an additional exercise at least annually that may include, but is not limited to the following:
(A) A second full-scale exercise that is community-based or an individual, facility-based functional exercise; or
(B) A mock disaster drill; or
(C) A tabletop exercise or workshop that includes a group discussion led by a facilitator, using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan.
(iii) Analyze the hospice's response to and maintain documentation of all drills, tabletop exercises, and emergency events and revise the hospice's emergency plan, as needed.
Secs. 1102, 1902, and 1928 of the Social Security Act (42 U.S.C. 1302).
The revisions and addition read as follows:
(a)
(4) Include a process for cooperation and collaboration with local, tribal, regional, State, and Federal emergency preparedness officials' efforts to maintain an integrated response during a disaster or emergency situation.
(b)
(c)
(d)
(1) * * *
(ii) After initial training, provide emergency preparedness training every 2 years.
(v) If the emergency preparedness policies and procedures are significantly updated, the PRTF must conduct training on the updated policies and procedures.
(2)
(i) Participate in a full-scale exercise annually that is community-based or when a community-based exercise is not accessible, an individual, facility-based functional exercise annually. If the PRTF experiences an actual natural or man-made emergency that requires activation of the emergency plan, the PRTF is exempt from engaging in its next required full-scale community-based or individual, facility-based functional exercise following the onset of the actual event.
(ii) Conduct an additional exercise at least annually that may include, but is not limited to the following:
(A) A second full-scale exercise that is community-based or individual, a facility-based functional exercise; or
(B) A mock disaster drill; or
(C) A tabletop exercise or workshop that includes a group discussion led by a facilitator, using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan.
(iii) Analyze the PRTF's response to and maintain documentation of all drills, tabletop exercises, and emergency events and revise the PRTF's emergency plan, as needed.
Secs: 1102, 1871, 1894(f), and 1934(f) of the Social Security Act (42 U.S.C. 1302, 1395, 1395eee(f), and 1396u-4(f)).
The revisions and addition read as follows:
(a)
(4) Include a process for cooperation and collaboration with local, tribal, regional, State, and Federal emergency preparedness officials' efforts to maintain an integrated response during a disaster or emergency situation.
(b)
(c)
(d)
(1) * * *
(ii) Provide emergency preparedness training at least every 2 years.
(v) If the emergency preparedness policies and procedures are significantly updated, the PACE must conduct training on the updated policies and procedures.
(2)
(i) Participate in a full-scale exercise that is community-based or when a community-based exercise is not accessible, an individual, facility-based functional exercise every 2 years. If the PACE experiences an actual natural or man-made emergency that requires activation of the emergency plan, the PACE is exempt from engaging in its next required full-scale community-based or individual, facility-based functional exercise following the onset of the actual event.
(ii) Conduct an additional exercise at least every 2 years opposite the year the full-scale or functional exercise under paragraph (d)(2)(i) of this section is conducted that may include, but is not limited to the following:
(A) A second full-scale exercise that is community-based or an individual, facility-based functional exercise; or
(B) A mock disaster drill; or
(C) A tabletop exercise or workshop that includes a group discussion led by a facilitator, using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan.
(iii) Analyze the PACE's response to and maintain documentation of all drills, tabletop exercises, and emergency events and revise the PACE's emergency plan, as needed.
Secs. 1102, 1871, and 1881 of the Social Security Act (42 U.S.C. 1302, 1395hh, and 1395rr), unless otherwise noted.
The revisions and addition read as follows:
(a)
(4) Include a process for cooperation and collaboration with local, tribal, regional, State, and Federal emergency preparedness officials' efforts to
(b)
(c)
(d)
(1) * * *
(ii) Provide emergency preparedness training at least every 2 years.
(v) If the emergency preparedness policies and procedures are significantly updated, the hospital must conduct training on the updated policies and procedures.
(2)
(i) Participate in an annual full-scale exercise that is community-based or when a community-based exercise is not accessible, an individual, facility-based functional exercise annually. If the hospital experiences an actual natural or man-made emergency that requires activation of the emergency plan, the hospital is exempt from engaging in its next required full-scale community-based exercise or individual, facility-based functional exercise following the onset of the actual event.
(ii) Conduct an additional exercise at least annually that may include, but is not limited to the following:
(A) A second full-scale exercise that is community-based or an individual, facility-based functional exercise; or
(B) A mock disaster drill; or
(C) A tabletop exercise or workshop that includes a group discussion led by a facilitator, using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan.
(iii) Analyze the hospital's response to and maintain documentation of all drills, tabletop exercises, and emergency events, and revise the hospital's emergency plan, as needed.
(f)
(1) The unified and integrated QAPI program is established in a manner that takes into account each member hospital's unique circumstances and any significant differences in patient populations and services offered in each hospital; and
(2) The unified and integrated QAPI program establishes and implements policies and procedures to ensure that the needs and concerns of each of its separately certified hospitals, regardless of practice or location, are given due consideration, and that the unified and integrated QAPI program has mechanisms in place to ensure that issues localized to particular hospitals are duly considered and addressed.
The revisions and additions read as follows:
(c) * * *
(5) * * *
(i) A medical history and physical examination be completed and documented for each patient no more than 30 days before or 24 hours after admission or registration, but prior to surgery or a procedure requiring anesthesia services, and except as provided under paragraph (c)(5)(iii) of this section. The medical history and physical examination must be completed and documented by a physician (as defined in section 1861(r) of the Act), an oromaxillofacial surgeon, or other qualified licensed individual in accordance with State law and hospital policy.
(ii) An updated examination of the patient, including any changes in the patient's condition, be completed and documented within 24 hours after admission or registration, but prior to surgery or a procedure requiring anesthesia services, when the medical history and physical examination are completed within 30 days before admission or registration, and except as provided under paragraph (c)(5)(iii) of this section. The updated examination of the patient, including any changes in the patient's condition, must be completed and documented by a physician (as defined in section 1861(r) of the Act), an oromaxillofacial surgeon, or other qualified licensed individual in accordance with State law and hospital policy.
(iii) An assessment of the patient (in lieu of the requirements of paragraphs (c)(5)(i) and (ii) of this section) be completed and documented after registration, but prior to surgery or a procedure requiring anesthesia services, when the patient is receiving specific outpatient surgical or procedural services and when the medical staff has chosen to develop and maintain a policy that identifies, in accordance with the requirements at paragraph (c)(5)(v) of this section, specific patients as not requiring a comprehensive medical history and physical examination, or any update to it, prior to specific outpatient surgical or procedural services. The assessment must be completed and documented by a physician (as defined in section 1861(r) of the Act), an oromaxillofacial surgeon, or other qualified licensed individual in accordance with State law and hospital policy.
(iv) The medical staff develop and maintain a policy that identifies those patients for whom the assessment requirements of paragraph (c)(5)(iii) of this section would apply. The provisions of paragraphs (c)(5)(iii), (iv), and (v) of this section do not apply to a medical staff that chooses to maintain a policy that adheres to the requirements of paragraphs of (c)(5)(i) and (ii) of this section for all patients.
(v) The medical staff, if it chooses to develop and maintain a policy for the identification of specific patients to whom the assessment requirements in paragraph (c)(5)(iii) of this section would apply, must demonstrate evidence that the policy applies only to those patients receiving specific outpatient surgical or procedural services as well as evidence that the policy is based on:
(A) Patient age, diagnoses, the type and number of surgeries and procedures scheduled to be performed, comorbidities, and the level of anesthesia required for the surgery or procedure.
(B) Nationally recognized guidelines and standards of practice for assessment of specific types of patients prior to specific outpatient surgeries and procedures.
(C) Applicable state and local health and safety laws.
(c) * * *
(4) * * *
(i) * * *
(A) A medical history and physical examination completed and documented no more than 30 days before or 24 hours after admission or registration, but prior to surgery or a procedure requiring anesthesia services, and except as provided under paragraph (c)(4)(i)(C) of this section. The medical history and physical examination must be placed in the patient's medical record within 24 hours after admission or registration, but prior to surgery or a procedure requiring anesthesia services.
(B) An updated examination of the patient, including any changes in the patient's condition, when the medical history and physical examination are completed within 30 days before admission or registration, and except as provided under paragraph (c)(4)(i)(C) of this section. Documentation of the updated examination must be placed in the patient's medical record within 24 hours after admission or registration, but prior to surgery or a procedure requiring anesthesia services.
(C) An assessment of the patient (in lieu of the requirements of paragraphs (c)(4)(i)(A) and (B) of this section) completed and documented after registration, but prior to surgery or a procedure requiring anesthesia services, when the patient is receiving specific outpatient surgical or procedural services and when the medical staff has chosen to develop and maintain a policy that identifies, in accordance with the requirements at § 482.22(c)(5)(v), specific patients as not requiring a comprehensive medical history and physical examination, or any update to it, prior to specific outpatient surgical or procedural services.
(c)
(1) The unified and integrated infection control program is established in a manner that takes into account each member hospital's unique circumstances and any significant differences in patient populations and services offered in each hospital;
(2) The unified and integrated infection control program establishes and implements policies and procedures to ensure that the needs and concerns of each of its separately certified hospitals, regardless of practice or location, are given due consideration;
(3) The unified and integrated infection control program has mechanisms in place to ensure that issues localized to particular hospitals are duly considered and addressed; and
(4) A qualified individual (or individuals) with expertise in infection prevention and control has been designated at the hospital as responsible for communicating with the unified infection control program, for implementing and maintaining the policies and procedures governing infection control as directed by the unified infection control program, and for providing infection prevention education and training to hospital staff.
(b) * * *
(1) * * *
(i) A medical history and physical examination must be completed and documented no more than 30 days before or 24 hours after admission or registration, and except as provided under paragraph (b)(1)(iii) of this section.
(ii) An updated examination of the patient, including any changes in the patient's condition, must be completed and documented within 24 hours after admission or registration when the medical history and physical examination are completed within 30 days before admission or registration, and except as provided under paragraph (b)(1)(iii) of this section.
(iii) An assessment of the patient must be completed and documented after registration (in lieu of the requirements of paragraphs (b)(1)(i) and (ii) of this section) when the patient is receiving specific outpatient surgical or procedural services and when the medical staff has chosen to develop and maintain a policy that identifies, in accordance with the requirements at § 482.22(c)(5)(v), specific patients as not requiring a comprehensive medical history and physical examination, or any update to it, prior to specific outpatient surgical or procedural services.
The revisions read as follows:
(b) * * *
(1) Resident rights (§ 483.10(b)(7), (c)(1), (c)(2)(iii), (c)(6), (d), (e)(2) and (4), (f)(4)(ii) and (iii), (h), (g)(8) and (17), and (g)(18) introductory text of this chapter).
(4) Social services (§ 483.40(d) of this chapter).
(7) Dental services (§ 483.55(a)(2), (3), (4), and (5) and (b) of this chapter).
(d)
The additions and revision read as follows:
(a) * * *
(5) National and transplant program-specific outcomes, from the most recent SRTR program-specific report, including (but not limited to) the transplant program's observed and expected 1-year patient and graft survival, and national 1-year patient and graft survival;
Secs. 1102, 1128I, 1819, 1871 and 1919 of the Social Security Act (42 U.S.C. 1302, 1320a-7, 1395i, 1395hh and 1396r).
The revisions and addition read as follows:
(a)
(4) Include a process for cooperation and collaboration with local, tribal, regional, State, or Federal emergency preparedness officials' efforts to maintain an integrated response during a disaster or emergency situation.
(b)
(c)
(d)
(1) * * *
(ii) Provide emergency preparedness training at least every 2 years.
(v) If the emergency preparedness policies and procedures are significantly updated, the LTC facility must conduct training on the updated policies and procedures.
(2)
(i) Participate in an annual full-scale exercise that is community-based or when a community-based exercise is not accessible, an individual, facility-based functional exercise annually. If the LTC facility experiences an actual natural or man-made emergency that requires activation of the emergency plan, the LTC facility is exempt from engaging its next required a full-scale community-based or individual, facility-based functional exercise following the onset of the actual event.
(ii) Conduct an additional exercise at least annually that may include, but is not limited to the following:
(A) A second full-scale exercise that is community-based or an individual, facility-based functional exercise; or
(B) A mock disaster drill; or
(C) A tabletop exercise or workshop that includes a group discussion led by
(iii) Analyze the LTC facility's response to and maintain documentation of all drills, tabletop exercises, and emergency events, and revise the LTC facility's emergency plan, as needed.
The revisions and addition read as follows:
(a)
(4) Include a process for cooperation and collaboration with local, tribal, regional, State, and Federal emergency preparedness officials' efforts to maintain an integrated response during a disaster or emergency situation.
(b)
(c)
(d)
(1) * * *
(ii) Provide emergency preparedness training at least every 2 years.
(v) If the emergency preparedness policies and procedures are significantly updated, the ICF/IID must conduct training on the updated policies and procedures.
(2)
(i) Participate in an annual full-scale exercise that is community-based or when a community-based exercise is not accessible, an individual, facility-based functional exercise annually. If the ICF/IID experiences an actual natural or man-made emergency that requires activation of the emergency plan, the ICF/IID is exempt from engaging in its next required full-scale community-based or individual, facility-based functional exercise following the onset of the actual event.
(ii) Conduct an additional exercise at least annually that may include, but is not limited to the following:
(A) A second full-scale exercise that is community-based or an individual, facility-based functional exercise; or
(B) A mock disaster drill; or
(C) A tabletop exercise or workshop that includes a group discussion led by a facilitator, using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan.
(iii) Analyze the ICF/IID's response to and maintain documentation of all drills, tabletop exercises, and emergency events, and revise the ICF/IID's emergency plan, as needed.
Secs. 1102 and 1871 of the Social Security Act (42 U.S.C. 1302 and 1395(hh)) unless otherwise indicated.
(c) * * *
(7) Be advised, orally and in writing, of—
(h) * * *
(3) If a deficiency in aide services is verified by the registered nurse or other appropriate skilled professional during an on-site visit, then the agency must conduct, and the home health aide must complete, retraining and a competency evaluation related to the deficient skill(s).
The revisions and addition read as follows:
(a)
(4) Include a process for cooperation and collaboration with local, tribal, regional, State, and Federal emergency preparedness officials' efforts to maintain an integrated response during a disaster or emergency situation.
(b)
(c)
(d)
(1) * * *
(ii) Provide emergency preparedness training at least every 2 years.
(v) If the emergency preparedness policies and procedures are significantly updated, the HHA must conduct training on the updated policies and procedures.
(2)
(i) Participate in a full-scale exercise that is community-based or when a community-based exercise is not accessible, an individual, facility-based functional exercise every 2 years. If the HHA experiences an actual natural or man-made emergency that requires activation of the emergency plan, the HHA is exempt from engaging in its next required full-scale community-based or individual, facility-based functional exercise following the onset of the actual event.
(ii) Conduct an additional exercise at least every 2 years, opposite the year the full-scale or functional exercise under paragraph (d)(2)(i) of this section is conducted, that may include, but is not limited to the following:
(A) A second full-scale exercise that is community-based or an individual, facility-based functional exercise; or
(B) A mock disaster drill; or
(C) A tabletop exercise or workshop that includes a group discussion led by a facilitator, using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan.
(iii) Analyze the HHA's response to and maintain documentation of all drills, tabletop exercises, and emergency events, and revise the HHA's emergency plan, as needed.
(e)
Secs. 1102 and 1871 of the Social Security Act (42 U.S.C. 1302 and 1395(hh)).
The facility must have in effect a written utilization review plan that is implemented annually, to assess the necessity of services and promotes the most efficient use of services provided by the facility.
The revisions and addition read as follows:
(a)
(4) Include a process for cooperation and collaboration with local, tribal, regional, State, and Federal emergency preparedness officials' efforts to maintain an integrated response during a disaster or emergency situation.
(b)
(c)
(d)
(1) * * *
(ii) Provide emergency preparedness training at least every 2 years.
(v) If the emergency preparedness policies and procedures are significantly updated, the CORF must conduct training on the updated policies and procedures.
(2)
(i) Participate in a full-scale exercise that is community-based or when a community-based exercise is not accessible, an individual, facility-based functional exercise every 2 years. If the CORF experiences an actual natural or man-made emergency that requires activation of the emergency plan, the CORF is exempt from engaging in its next required community-based or individual, facility-based functional exercise following the onset of the actual event.
(ii) Conduct an additional exercise at least every 2 years, opposite the year the full-scale or functional exercise under paragraph (d)(2)(i) of this section is conducted, that may include, but is not limited to the following:
(A) A second full-scale exercise that is community-based or an individual, facility-based functional exercise; or
(B) A mock disaster drill; or
(C) A tabletop exercise or workshop that includes a group discussion led by a facilitator, using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan.
(iii) Analyze the CORF's response to and maintain documentation of all drills, tabletop exercises, and emergency events, and revise the CORF's emergency plan, as needed.
The revisions and addition read as follows:
(a)
(4) Include a process for cooperation and collaboration with local, tribal, regional, State, and Federal emergency preparedness officials' efforts to maintain an integrated response during a disaster or emergency situation.
(b)
(c)
(d)
(1) * * *
(ii) Provide emergency preparedness training at least every 2 years.
(v) If the emergency preparedness policies and procedures are significantly updated, the CAH must conduct training on the updated policies and procedures.
(2)
(i) Participate in a full-scale exercise that is community-based or when a community-based exercise is not accessible, an individual, facility-based functional exercise once per year. If the CAH experiences an actual natural or man-made emergency that requires activation of the emergency plan, the CAH is exempt from engaging in its next required full-scale community-based or individual, facility-based functional exercise following the onset of the actual event.
(ii) Conduct an additional exercise at least annually, that may include, but is not limited to the following:
(A) A second full-scale exercise that is community-based or an individual, facility-based functional exercise; or
(B) A mock disaster drill; or
(C) A tabletop exercise or workshop that includes a group discussion led by a facilitator, using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan.
(iii) Analyze the CAH's response to and maintain documentation of all drills, tabletop exercises, and emergency events, and revise the CAH's emergency plan, as needed.
(a) * * *
(4) These policies are reviewed at least biennially by the group of professional personnel required under paragraph (a)(2) of this section and updated as necessary by the CAH.
The revisions read as follows:
(d) * * *
(1) Resident rights (§ 483.10(b)(7), (c)(1), (c)(2)(iii), (c)(6), (d), (e)(2) and (4), (f)(4)(ii) and (iii), (g)(8) and (17), (g)(18) introductory text, and (h) of this chapter).
(4) Social services (§ 483.40(d) of this chapter).
(7) Dental services (§ 483.55(a)(2), (3), (4), and (5) and (b) of this chapter).
The revisions and addition read as follows:
(a)
(5) Include a process for cooperation and collaboration with local, tribal, regional, State, and Federal emergency preparedness officials' efforts to maintain an integrated response during a disaster or emergency situation.
(b)
(c)
(d)
(1) * * *
(ii) Provide emergency preparedness training at least every 2 years.
(v) If the emergency preparedness policies and procedures are significantly updated, the Organizations must conduct training on the updated policies and procedures.
(2)
(i) Participate in a full-scale exercise that is community-based or when a community-based exercise is not accessible, an individual, facility-based functional exercise every 2 years. If the Organizations experience an actual natural or man-made emergency that requires activation of the emergency plan, the organization is exempt from engaging in its next required full-scale community-based or individual, facility-based functional exercise following the onset of the actual event.
(ii) Conduct an additional exercise at least every 2 years, opposite the year the full-scale or functional exercise under paragraph (d)(2)(i) of this section is conducted, that may include, but is not limited to the following:
(A) A second full-scale exercise that is community-based or an individual, facility-based functional exercise; or
(B) A mock disaster drill; or
(C) A tabletop exercise or workshop that includes a group discussion led by a facilitator, using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan.
(iii) Analyze the Organization's response to and maintain documentation of all drills, tabletop exercises, and emergency events, and revise their emergency plan, as needed.
(d) * * *
(1) The CMHC must update each client's comprehensive assessment via the CMHC interdisciplinary treatment team, in consultation with the client's primary health care provider (if any), when changes in the client's status, responses to treatment, or goal achievement have occurred and in accordance with current standards of practice.
(3) For clients that receive PHP services, the assessment must be updated no less frequently than every 30 days.
(a)
(4) Include a process for cooperation and collaboration with local, tribal, regional, State, and Federal emergency preparedness officials' efforts to maintain an integrated response during a disaster or emergency situation.
(b)
(c)
(d)
(1)
(2)
(i) Participate in a full-scale exercise that is community-based or when a community-based exercise is not accessible, an individual, facility-based every 2 years. If the CMHC experiences an actual natural or man-made emergency that requires activation of the emergency plan, the CMHC is exempt from engaging in its next required community-based or individual, facility-based functional exercise following the onset of the actual event.
(ii) Conduct an additional exercise at least every 2 years, opposite the year the full-scale or functional exercise under paragraph (d)(2)(i) of this section is conducted, that may include, but is not limited to following:
(A) A second full-scale exercise that is community-based or an individual, facility-based functional exercise; or
(B) A mock disaster drill; or
(C) A tabletop exercise or workshop that includes a group discussion led by a facilitator, using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan.
(iii) Analyze the CMHC's response to and maintain documentation of all drills, tabletop exercises, and emergency events, and revise the CMHC's emergency plan, as needed.
Secs. 1102, 1138, and 1871 of the Social Security Act (42 U.S.C. 1302, 1320b-8, and 1395hh) and section 371 of the Public Health Service Act (42 U.S.C 273).
(a)
(1) Successful completion of a program of formal training in X-ray technology at which the operator received appropriate training and demonstrated competence in the use of equipment and administration of portable x-ray procedures; or
(2) Successful completion of 24 full months of training and experience under the direct supervision of a physician who is certified in radiology or who possesses qualifications which are equivalent to those required for such certification.
(a) * * *
(2) Such physician or nonphysician practitioner's order meets the requirements at § 410.32 of this chapter, and includes a statement concerning the condition of the patient which indicates why portable X-ray services are necessary.
The revisions and addition read as follows:
(a)
(4) Include a process for cooperation and collaboration with local, tribal, regional, State, and Federal emergency preparedness officials' efforts to maintain an integrated response during a disaster or emergency situation.
(b)
(c)
(d)
(1) * * *
(ii) Provide emergency preparedness training at every 2 years.
(v) If the emergency preparedness policies and procedures are significantly updated, the OPO must conduct training on the updated policies and procedures.
(2) * * *
(i) Conduct a paper-based, tabletop exercise or workshop at least annually. A tabletop exercise is a group discussion led by a facilitator, using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan. If the OPO experiences an actual natural or man-made emergency that requires activation of the emergency plan, the OPO is exempt from engaging in its next required testing exercise following the onset of the actual event.
Secs. 1102, 1128l, 1864, 1865, 1871 and 1875 of the Social Security Act, unless otherwise noted (42 U.S.C 1302, 1320a-7j, 1395aa, 1395bb, 1395hh and 1395ll).
The revisions read as follows:
(a) * * *
(5) If CMS determines that a transplant program has met the data submission, clinical experience, and outcome requirements, CMS will review the program's compliance with the conditions of participation contained at §§ 482.72 through 482.76 and §§ 482.90 through 482.104 of this chapter using the procedures described in subpart A of this part. If the transplant program is found to be in compliance with all the conditions of participation at §§ 482.72 through 482.104 of this chapter, CMS will notify the transplant program in writing of the effective date of its Medicare-approval. CMS will notify the transplant program in writing if it is not Medicare-approved.
(c)
(1) Request initial approval using the procedures described in paragraph (a) of this section;
(2) Be in compliance with §§ 482.72 through 482.104 of this chapter at the time of the request for Medicare approval; and
(3) Submit a report to CMS documenting any changes or corrective actions taken by the program as a result of the loss of its Medicare approval status.
(d)
(e)
(iv) Program improvements that substantially address root causes of graft failures or patient deaths, that have been implemented and institutionalized on a sustainable basis, and that are supported by outcomes more recent than the latest available SRTR report, for which there is a sufficient post-transplant patient and graft survival period and a sufficient number of transplants such that CMS finds that the program demonstrates present-day compliance with the requirements at § 482.80(c)(2)(ii)(C) of this chapter;
(3)
(f) * * *
(1) * * *
(i) Approve initial approval of a program's Medicare participation based upon approval of mitigating factors.
(ii) Deny the program's request for Medicare approval based on mitigating factors.
(iii) Offer a time-limited Systems Improvement Agreement, in accordance with paragraph (g) of this section, when a transplant program has waived its appeal rights, has implemented substantial program improvements that address root causes and are institutionally supported by the hospital's governing body on a sustainable basis, and has requested more time to design or implement additional improvements or demonstrate compliance with CMS outcome requirements. Upon completion of the Systems Improvement Agreement or a CMS finding that the hospital has failed to meet the terms of the Agreement, CMS makes a final determination of whether to approve or deny a program's request for Medicare approval based on mitigating factors. A Systems Improvement Agreement follows the process specified in paragraph (g) of this section.
Sec. 1102 of the Social Security Act (42 U.S.C. 1302); and sec. 353 of the Public Health Service Act (42 U.S.C. 263a).
(b) * * *
(4) These policies are reviewed at least biennially by the group of professional personnel required under paragraph (b)(2) of this section and reviewed as necessary by the RHC or FQHC.
(a) The clinic or center carries out, or arranges for, a biennial evaluation of its total program.
The revisions and addition read as follows:
(a)
(4) Include a process for cooperation and collaboration with local, tribal, regional, State, and Federal emergency preparedness officials' efforts to maintain an integrated response during a disaster or emergency situation.
(b)
(c)
(d)
(1) * * *
(ii) Provide emergency preparedness training at least every 2 years.
(v) If the emergency preparedness policies and procedures are significantly updated, the RHC/FQHC must conduct training on the updated policies and procedures.
(2)
(i) Participate in a full-scale exercise that is community-based or when a community-based exercise is not accessible, an individual, facility-based functional exercise every 2 years. If the RHC or FQHC experiences an actual natural or man-made emergency that requires activation of the emergency plan, the RHC or FQHC is exempt from engaging in its next required full-scale community-based or individual, facility-based functional exercise following the onset of the actual event.
(ii) Conduct an additional exercise at least every 2 years, opposite the year the full-scale or functional exercise under paragraph (d)(2)(i) of this section is conducted, that may include, but is not limited to following:
(A) A second full-scale exercise that is community-based or an individual, facility-based functional exercise; or
(B) A mock disaster drill; or
(C) A tabletop exercise or workshop that includes a group discussion led by a facilitator, using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan.
(iii) Analyze the RHC or FQHC's response to and maintain documentation of all drills, tabletop exercises, and emergency events, and revise the RHC or FQHC's emergency plan, as needed.
Secs. 1102 and 1871 of the Social Security Act (42 U.S.C. l302 and l395hh).
The revisions and addition read as follows:
(a)
(4) Include a process for cooperation and collaboration with local, tribal, regional, State, and Federal emergency preparedness officials' efforts to maintain an integrated response during a disaster or emergency situation. The dialysis facility must contact the local emergency preparedness agency at least annually to confirm that the agency is aware of the dialysis facility's needs in the event of an emergency.
(b)
(c)
(d)
(1) * * *
(ii) Provide emergency preparedness training at least every 2 years.
(vii) If the emergency preparedness policies and procedures are significantly updated, the dialysis facility must conduct training on the updated policies and procedures.
(2)
(i) Participate in a full-scale exercise that is community-based or when a community-based exercise is not accessible, an individual, a facility-based functional exercise every 2 years. If the dialysis facility experiences an actual natural or man-made emergency that requires activation of the emergency plan, the ESRD is exempt from engaging in its next required full-scale community-based or individual, facility-based functional exercise following the onset of the actual event.
(ii) Conduct an additional exercise at least every 2 years, opposite the year the full-scale or functional exercise under paragraph (d)(2)(i) of this section is conducted, that may include, but is not limited to the following:
(A) A second full-scale exercise that is community-based or an individual, facility-based functional exercise; or
(B) A mock disaster drill; or
(C) A tabletop exercise or workshop that includes a group discussion led by a facilitator, using a narrated, clinically-relevant emergency scenario, and a set of problem statements, directed messages, or prepared questions designed to challenge an emergency plan.
(iii) Analyze the dialysis facility's response to and maintain documentation of all drills, tabletop exercises, and emergency events, and revise the dialysis facility's emergency plan, as needed.
Federal Motor Carrier Safety Administration (FMCSA), DOT.
Notice of proposed rulemaking (NPRM); request for comments.
FMCSA proposes to amend its May 27, 2015,
Comments must be received by November 19, 2018.
You may submit comments identified by Docket Number FMCSA-2012-0103 using any of the following methods:
•
•
•
•
To avoid duplication, please use only one of these four methods. See the “Public Participation and Request for Comments” portion of the
Ms. Loretta Bitner, (202) 366-2400,
This notice of proposed rulemaking (NPRM) is organized as follows:
FMCSA encourages you to participate in this rulemaking by submitting comments, reply comments, and related materials. All comments received will be posted without change to
If you submit a comment, please include the docket number for this NPRM (Docket No. FMCSA-2012-0103), indicate the specific section of this document to which each comment applies, and provide a reason for each recommendation. You may submit your comments and material online or by fax, mail, or hand delivery, but please use only one of these means. FMCSA recommends that you include your name and a mailing address, an email address, or a phone number in the body of your document so that the Agency can contact you if there are questions regarding your submission.
To submit your comment online, go to
If you submit your comments by mail or hand delivery, submit them in an unbound format, no larger than 8
FMCSA will consider all comments and material received during the comment period and may change this proposed rule based on your comments. FMCSA may issue a final rule at any time after the close of the comment period.
To view comments, as well as any documents mentioned in this preamble
In accordance with 5 U.S.C. 553(c), DOT solicits comments from the public to better inform its rulemaking process. DOT posts these comments, without edit, including any personal information the commenter provides, to
Under 49 U.S.C. 31136(g)(1), as amended by section 5202 of the Fixing America's Surface Transportation (FAST) Act, Public Law 114-94, for any regulatory proposal likely to lead to the publication of a major rule,. FMCSA is required to publish an advance notice of proposed rulemaking (ANPRM), unless the Agency finds good cause pursuant to sec. 31136(g)(3) that an ANPRM is impracticable, unnecessary, or contrary to the public interest. For purposes of compliance with the FAST Act, the Agency has adopted the Congressional Review Act's definition of “major rule” (5 U.S.C. 804(2)), namely a rule that has an annual effect on the economy of $100 million or more. This final rule is not a major rule by that standard and 49 U.S.C. 31136(g)(1) therefore does not apply. Even if it were a major rule, however, FMCSA would find an ANPRM to be unnecessary.
On August 31, 2016, FMCSA published a notice of intent (2016 NOI) announcing that four potential changes to the final rule were under consideration and its plan to issue a rulemaking notice to reconsider those four areas of concern (81 FR 59951). The four changes are discussed in more detail later in this proposal.
FMCSA held a public roundtable on October 31, 2016 to discuss the four issues outlined in the 2016 NOI. The stakeholders represented spoke about those issues and provided information on how to address them. All public comments were placed in the docket of this rulemaking.
On June 16, 2017, FMCSA published a proposal (2017 proposal) in the
The Agency's intent to issue this NPRM has been announced repeatedly, with opportunities for stakeholder comment available at each stage. Therefore, FMCSA believes a further opportunity to provide comments before issuance of this NPRM would be unnecessary.
If you have comments on the collection of information discussed in this NPRM, you must also send those comments to the Office of Information and Regulatory Affairs at Office of Management and Budget (OMB). To ensure that your comments are received on time, the preferred methods of submission are by email to
Based on a review of the petitions for reconsideration and stakeholder input, FMCSA proposes to revise its regulations governing the lease and interchange of passenger-carrying commercial motor vehicles (CMVs). This proposed rule would exclude motor carriers that operate CMVs and have active operating authority registration with FMCSA to transport passengers—hereafter called “authorized carriers” or “carriers with operating authority” for the sake of simplicity—from the lease and interchange requirements. For leases between authorized carriers, because FMCSA believes their identity can be determined by other means, the assignment of responsibility for regulatory compliance would require no additional regulatory obligations.
FMCSA also proposes to extend the compliance date for the 2015 final rule to January 1, 2021, to give the Agency sufficient time to complete this rulemaking.
The proposed rule would (1) revise the definition of
The Agency estimates that annually 8,215 motor carriers of passengers and
As presented in Table 1, the Agency estimates that the proposed rule would result in a cost savings of $75.1 million on an undiscounted basis, $66.5 million discounted at 3 percent, and $57.5 million discounted at 7 percent over the 10-year analysis period. Expressed on an annualized basis, this equates to a 10-year cost savings of $7.8 million at a 3 percent discount rate and $8.2 million at a 7 percent discount rate.
The regulatory evaluation for the 2015 final rule addressed the potential safety benefits of lease and interchange requirements for motor carriers of passengers.
In considering the potential impact to safety benefits from today's proposed rule, the Agency notes that there remains insufficient data and empirical evidence to clearly demonstrate a measurable quantitative relationship between lease and interchange requirements for passenger-carrying CMVs and improved safety outcomes. Lease and interchange requirements for motor carriers of passengers improve the ability of the Agency and our State partners to attribute the inspection, compliance, enforcement, and safety data to the correct motor carrier and driver, allowing FMCSA and our State partners to more accurately identify unsafe carriers and initiate appropriate interventions. FMCSA believes that the lease and interchange requirements of the proposed rule are a less costly and burdensome regulatory approach than the requirements of the 2015 final rule, yet still enable safety officials and the general public to sufficiently identify the passenger carrier responsible for safety. Therefore, the Agency does not anticipate any change to safety benefits as a result of the proposed rule.
This rule is based on the authority of the Motor Carrier Act of 1935 (1935 Act) and the Motor Carrier Safety Act of 1984 (1984 Act), as amended.
The 1935 Act authorizes DOT to “prescribe requirements for—(1) qualifications and maximum hours of service of employees of, and safety of operation and equipment of, a motor carrier; and (2) qualifications and maximum hours of service of employees of, and standards of equipment of, a motor private carrier, when needed to promote safety of operation” (49 U.S.C. 31502(b)).
The 1984 Act confers on DOT authority to regulate drivers, motor carriers, and vehicle equipment. “At a minimum, the regulations shall ensure that—(1) commercial motor vehicles are maintained, equipped, loaded, and operated safely; (2) the responsibilities imposed on operators of commercial motor vehicles do not impair their ability to operate the vehicles safely; (3) the physical condition of operators of commercial motor vehicles is adequate to enable them to operate the vehicles safely . . .; and (4) the operation of commercial motor vehicles does not have a deleterious effect on the physical condition of the operators” (49 U.S.C. 31136(a)). Section 32911 of the Moving Ahead for Progress in the 21st Century Act (MAP-21) [Pub. L. 112-141, 126 Stat. 405, 818, July 6, 2012] enacted a fifth requirement,
The 1984 Act also includes more general authority to “(8) prescribe recordkeeping . . . requirements; . . . and (10) perform other acts the Secretary considers appropriate” (49 U.S.C. 31133(a)).
This rule imposes legal and recordkeeping requirements consistent with the 1935 and 1984 Acts on certain for-hire and private passenger carriers that operate CMVs, to enable safety officials and the general public to identify the passenger carrier responsible for safety. Currently, passenger-carrying CMVs and drivers are frequently rented, loaned, leased, interchanged, assigned, and reassigned with few records and little formality, thus obscuring the operational safety responsibility of many industry participants. Because this rule has only indirect and minimal application to drivers of passenger-carrying CMVs—at most, their employers might require them to pick up a lease document and place it on the vehicle, though that task could also be assigned to other employees—FMCSA believes that coercion of drivers to violate the rule will not occur.
Before prescribing any regulations, FMCSA must also consider their “costs and benefits” (49 U.S.C. 31136(c)(2)(A) and 31502(d)). Those factors are also discussed in this proposed rule.
On September 20, 2013, FMCSA published an NPRM that discussed the National Transportation Safety Board's (NTSB) recommendation that FMCSA regulate the leasing of passenger carriers in much the same way as it regulates the leasing of for-hire property carriers (78 FR 57822). This NTSB recommendation resulted from several investigations of bus crashes that occurred in 2008 (78 FR 57822, 57824-57826). Starting in 2011, FMCSA investigated bus companies operating unsafely along the I-95 corridor. That investigation uncovered additional problems and serious safety violations with other carriers. As Agency investigators tried to understand the relationships and links between bus companies operating in complex networks, they encountered significant difficulties in identifying the motor carriers responsible for regulatory compliance on numerous trips. Vehicles and drivers were found to be frequently rented, loaned, leased, interchanged, assigned, and reassigned with few records and little formality, which obscured the operational safety responsibility of many industry participants. Multiple affiliated entities shared drivers and vehicles within their network intentionally to avoid identification of the motor carrier responsible for safety management, and to conceal excessive and illegal driver work hours that resulted in fatigue-related crashes in some cases.
Investigators were eventually able to document multiple patterns of serious safety violations by three networks of businesses that deliberately structured their operations to evade Federal regulatory oversight. Each time FMCSA had shut them down in the past, the three networks re-created or reincarnated themselves. These companies, which together transported almost 2,000 passengers daily, showed flagrant disregard for public safety by using drivers without valid commercial driver's licenses or medical qualification certificates, failing to conduct required drug testing of drivers, allowing or requiring drivers to exceed the maximum number of driving hours, and operating buses that were mechanically unsafe and in disrepair. FMCSA shut down these three networks of bus operators after a time-consuming, complex and detailed review of their operations.
In response to an NPRM intended to better ensure the correct identity of the motor carrier responsible for the operation of a passenger-carrying vehicle, 12 parties submitted comments. On May 27, 2015, FMCSA published a final rule (2015 final rule) concerning the lease and interchange of passenger-carrying CMVs (80 FR 30164). Although several of the proposed regulations were revised in response to comments received in response to the NPRM, the motorcoach industry took exception to some of the requirements of the final rule. The Agency published several documents to respond to the industry objections. These documents are discussed in detail in the following section.
The American Bus Association (ABA) and United Motorcoach Association (UMA) filed a joint request for an extension of the June 26, 2015, deadline for the submission of petitions for reconsideration of the final rule. On July 1, 2015, FMCSA extended the deadline to August 25, 2015 (80 FR 37553).
The Agency ultimately received 37 petitions for reconsideration which have been filed in the public docket referenced above. In addition, 11 informal comments were received. Upon review of these requests, FMCSA concluded that some have merit. FMCSA, therefore, extended the compliance date of the final rule from January 1, 2017, to January 1, 2018, to allow the Agency time to complete its analysis and amend the rule where necessary (82 FR 13998, Mar. 16, 2016).
The petitioners argued and explained in more detail that FMCSA had taken a regulatory scheme from the trucking industry and applied it to the bus industry, which has a vastly different operating structure and liability regime. Moreover, the application of these truck regulations to the bus industry offered no additional protection to the public from illegal or unsafe bus operators.
Petitioners further stated that the final rule created an economic and regulatory burden for passenger carriers that already operate safely and have a high degree of compliance. By imposing lease requirements, some of the petitioners argued, the rule did not affect carriers that choose to violate the regulations, but instead burdened those who already operate safely and are in compliance. Another petitioner stated that, while it supported efforts to identify and address chameleon carriers or carriers that may try to operate under the cloak of another carrier, the final rule did not accomplish this goal and, in fact, provided a roadmap for irresponsible carriers to operate legally under the authority of another carrier.
One carrier stated that it had identified several instances where the final rule lacked sufficient clarity to enable it to comply, and that these issue areas affected all of its operations. The final rule also added administrative costs and reduced operational flexibility for charter and tour bus operations, which would, in the end, reduce connectivity and transportation options for the traveling public. Another carrier named two insurance companies that have restrictions in their policies that prohibit the use of non-owned equipment and non-employed drivers, which were major concerns of the NPRM and final rule.
On August 31, 2016, FMCSA published the 2016 NOI announcing that the following four potential changes to the final rule were under consideration:
(1) Exclusion of “chartering” from the definition of
(2) Amending the CMV requirements for the location of temporary markings for leased/interchanged vehicles (49 CFR 390.21(f), 390.303(f)). The petitioners argued that the frequent marking changes needed during leases or interchanges would be impractical and unnecessary because the information required is recorded on the driver's records of duty status for safety inspectors and safety investigators to review; carriers would have to depend completely on drivers to properly change vehicle markings dozens of times per day in remote locations; and it would be unlikely that a member of the public would understand the significance of the markings in the event that he or she focused on the temporary “operated by” markings rather than the permanent markings on the bus representing the vehicle owner or long-term lessee.
(3) Changing the requirement that carriers notify customers within 24 hours when they subcontract service to other carriers (49 CFR 390.305). Petitioners argued that a 24-hour deadline is impractical because if an emergency maintenance issue occurs, it may not be possible to notify the customer in a timely manner, particularly if the issue occurs on the weekend, when the customer's offices are closed, and the trip is scheduled to start before the customer's Monday opening time.
(4) Expanding the 48-hour delay in preparing a lease to include emergencies when passengers are not actually on board a bus (49 CFR 390.303(a)(2)). Sometimes events requiring a replacement vehicle might occur when there are no passengers on a vehicle, such as when Amtrak or airline service is suspended or disrupted and buses are needed to transport stranded passengers. A bus operator contracted to provide the emergency service might need to obtain additional drivers and vehicles from other carriers to meet the demand. There might be a last-minute maintenance or mechanical issue, or driver illness, that arises late in the evening or during the night (such as on a multi-day charter or tour trip), or just prior to picking up a group for a charter or scheduled service run.
In the 2016 NOI, FMCSA announced its plan to issue a rulemaking notice to reconsider the four areas of concern listed above. The Agency expressed its belief that it might be possible to adopt less burdensome regulatory alternatives that would not adversely impact safety. FMCSA also explicitly denied other requested revisions because they would either have impaired the purpose of the final rule or did not represent practical alternatives.
FMCSA held a public roundtable on October 31, 2016 to discuss the four issues outlined in the 2016 NOI. The stakeholders represented spoke about those issues and provided the Agency with information on how to address them. All public comments were placed in the docket of this rulemaking.
On June 16, 2017, FMCSA published a final rule (2017 final rule) and a 2017 proposal in the
FMCSA received 24 comments in response to the 2017 proposal regarding the petitions for reconsideration. Two submissions requested an extension of time to comment, one from Coach USA and another from Adirondack Trailways, Pine Hill Trailways and New York Trailways.
The following commenters (hereafter the “industry commenters”), submitted responses to the June 2017 proposal that were largely the same, both in wording and in format. The industry commenters include: AC Coach Operations, Inc. dba Anderson Coach and Travel, Adirondack Trailways, Pine Hill Trailways and New York Trailways (Responding together), ABA, Beeline Charters and Tours, Burlington Trailways, California Bus Association, Capitol Bus Lines Inc., Connecticut Bus Association, FTI Coach Lines, Georgia Motorcoach Operators Association, Indian Trails, Inc., Minnesota Charter Bus Operator's Association, Onondaga Coach Corp., Pennsylvania Bus Association, Shuttle Express, Inc., and Trans-Bridge Lines.
FMCSA also received unique comments from Academy Bus LLC and Greyhound Lines, Inc.; Delainey Banks, an individual; Coach USA, a non-carrier entity that controls numerous motor carriers of passengers; Reston Limousine; National Interstate Insurance; and the UMA.
Neither the 2016 NOI nor the 2017 proposal contained specific regulatory text. The 2016 NOI announced FMCSA's intent to revise the 2015 final rule in response to petitions. As indicated above, the 2016 NOI described four major changes that were under consideration for regulatory changes.
In the 2017 proposal, the Agency identified its intention to revise the regulations to address “chartering” and the 48 hour delay in preparing a lease.
The 2015 final rule merged the concepts of leasing and chartering (or subcontracting). Carriers routinely subcontract work to other registered carriers to handle demand surges, emergencies, or events that require more than their available capacity.
According to Coach USA Inc. and other commenters, the rule broadens the term “lease” to capture charter and similar operations, thus placing unnecessary burdens on compliant motor coach operators, while doing little to target the safety concern associated with non-compliant carriers. Commenters believed FMCSA should exclude from the definition of “Lease” in § 390.5 all passenger-carrying motor carriers that have FMCSA operating authority. Specifically, they asked the Agency to modify the definition of “Lease” by clarifying that it does not include a “contract, subcontract, sublease, rental or charter arrangement between two or more passenger-carrying motor carriers where all parties have operating authority.”
The Minnesota Charter Bus Operator's Association stated that the rule would prohibit the necessary collaboration among multiple operators to meet the needs of large events that occur in Minnesota. This commenter added that the nature of the business requires operators to assist one another in the event of a mechanical breakdown, so they have to act quickly to service and protect the traveling public without the burden of the lease and marking requirement. Capitol Bus Lines, Inc. reported that, as a result of its need to comply with the 2015 final rule requirements, it lost the ability to provide shuttle service for a large fireworks display, which cost the company business. UMA believed the rule needlessly harms passenger groups and carriers in need of immediate assistance. Greyhound wrote the rule would severely curtail, if not eliminate, its leasing of buses to meet peak period demand.
Industry commenters believed that the rule may exacerbate the problem of non-compliant carriers by creating safe havens and encouraging a switch from chartering to passenger broker operations that the Agency has no authority to regulate. UMA commented that the rule does not identify chameleon carriers, but instead provides a roadmap for carriers that may have compliance or operating authority issues. UMA thought the rule might compel special event organizers and community leaders to spend needless time engaging multiple carriers or to turn to brokers.
While many commenters, including National Interstate Insurance, supported the exclusion of “chartering” from the leasing requirements of the rule, as stated in the 2017 proposal, some commenters, including Greyhound Lines, Inc., UMA, and Reston Limousine, wanted the Agency to clarify this term. In their joint request for an extension of time Adirondack Trailways, Pine Hill Trailways, and New York Trailways noted that the proposal equates “chartering” to “subcontracting” in one section, but then excludes the term “chartering” from the entire rule. Reston Limousine suggested defining “lease” to exclude contracts, subcontracts, or charter arrangements between two or more passenger-carrying motor carriers with valid individual USDOT operating authority.
Coach USA commented that the administrative and paperwork burden associated with the full range of other regulatory obligations related to chartering/subcontracting arrangements would be prohibitive. Further, Coach USA did not believe that it would be possible for a primary contractor to obtain insurance for vehicles operated by subcontractor, as the final rule seems to require. Coach USA noted that it is not practicable for the primary carrier to ensure that the subcontracting carrier is in full compliance with many FMCSA regulations, particularly given that arrangements with secondary carriers must often be made at the last minute.
Industry commenters added that the Agency should clarify that the current definition of the term “interchange” in § 390.5, as used in § 390.21(f) and subpart F of part 390, does not include the act of providing a passenger-carrying CMV by one motor carrier of passengers to another. The industry commenters suggested edits to the definition of “interchange” that they believed would resolve the issue.
The 2015 final rule governing the lease and interchange of passenger-carrying CMVs holds the lessee carrier directly responsible for violations of the FMCSRs.
The 2015 final rule added a new § 390.21(f) to cover the marking of leased and interchanged passenger-carrying CMVs, as defined in § 390.5 (80 FR 30178). Carriers operating such CMVs must meet certain standards for marking in § 390.21. They must also display a placard, sign, or other permanent or removable device on the right (curb) side of the passenger-carrying CMV on or near the front passenger door. The device must show the name and USDOT number of the carrier operating the vehicle, preceded by the words “operated by,”
In its comments, Coach USA recommended that the Agency eliminate the requirement to change vehicle markings when vehicles are exchanged between commonly owned carriers. Coach USA wrote that changing markings on vehicles exchanged between commonly-owned Coach USA companies would be highly burdensome given the large number of such exchanges. Coach USA commented that magnetic marking placards and paper signs are not a practical option. Placing a sign on the inside of the bus could obstruct the driver's view and/or would not meet the legibility requirements due to window glare or window tinting.
Coach USA also argued that requiring vehicles interchanged between commonly-owned companies to be marked in accordance with § 390.21 is likely to cause more confusion among passengers than it resolves. It reported that most of the vehicle exchanges between Coach USA carriers occur between companies that have “Megabus.com” written across their vehicles in huge letters. From the public's perspective, these motorcoaches are operated by Megabus. Coach USA did not believe that individuals would understand the temporary markings required by § 390.21 and thought they would result in confusion.
Greyhound Lines Inc. urged FMCSA to exempt from the temporary marking or placarding requirements the operation of vehicles that are being leased or interchanged between carriers that have FMCSA operating authority.
If a motor carrier was originally hired to provide charter transportation of passengers and subsequently subcontracted this work to another motor carrier of passengers, the 2015 final rule required the original motor carrier to notify the tour operator or group of passengers within 24 hours after hiring the subcontractor and advising that the transportation would be provided by the subcontractor. The 2016 NOI said that FMCSA was reconsidering that requirement based on petitioners' arguments that the 24-hour deadline is impractical in an emergency.
Academy Bus LLC noted that the 24-hour notice to customers was not addressed in the 2017 proposal and said the issue was still of concern. Academy Bus LLC added that the industry is required to be flexible and respond to the public demand on very short notice.
Coach USA believed that excluding chartering and subcontracting arrangements would also eliminate the requirement to notify customers of subcontracting arrangements. Coach USA, however, supported a notification requirement for carriers that had been prohibited from operating by FMCSA or a State and intended to lease, interchange or otherwise convey use of a vehicle to another carrier. In fact, Coach USA argued that these carriers must provide written notice to FMCSA before taking such an action.
When passengers are on a CMV and an emergency occurs that requires a replacement vehicle from another motor carrier, § 390.303(a)(2) allows the two carriers to postpone writing a lease or other written agreement for up to 48 hours. The Agency believed the 48-hour window would provide ample time for the parties to document the transaction.
One of the issues listed in the 2016 NOI was that FMCSA would reconsider expanding applicability of the 48-hour delay provision for preparing a lease to include emergencies when passengers are not actually on board a bus (81 FR 59952, Aug. 31, 2016). FMCSA provided examples of events that might require a motor carrier to obtain a replacement vehicle immediately:
• Buses might be needed to transport stranded passengers in the event that Amtrak or airline service was suspended or disrupted. A bus operator contracted to provide emergency service might need to obtain additional drivers and vehicles without delay;
• Last minute maintenance or mechanical issues, or driver illness, might arise late in the evening or during the night (such as on a multi-day charter or tour trip), or just prior to picking up
In the 2017 proposal, FMCSA explained that it intended to broaden the emergency 48-hour delay provision for preparing a lease authorized by 49 CFR 390.303(a)(2) and remove the requirement that passengers actually be on board a bus when the exception occurs.
An individual believed that the 48-hour time period for preparing leases might be a good idea for the trucking industry, but that is not the case for passenger carriers. This commenter stated that at peak times “every worker is stretched thin and there is a need to bring in more operators to provide the same services,” otherwise customers may be left stranded. In these instances, it is “an emergency to both the busing companies and the customers to bring in another operator to provide the necessary backup to complete the job in an efficient manner. To combat this situation, companies need to work together before, during and after leasing passenger vehicles.” This commenter also recommended that accountability be placed directly on the subcontractor and its driver.
Coach USA wrote that the exception in 49 CFR 390.303(a)(2) would likely apply only in rare instances if FMCSA exempted chartering and subcontracting arrangements from the regulations. Coach USA supported extending the 48-hour delay to cases of emergencies where passengers are not yet on the bus. Because operators will likely not have time to mark vehicles in the event of an emergency that requires replacement of a vehicle on very short notice, Coach USA proposed eliminating the final sentence of § 390.303(a)(2), “The lessee must also mark the vehicle in accordance with § 390.21(f) before operating it.”
In § 390.301(b)(2), the 2015 rule allows passenger-carrying CMVs to be exchanged or interchanged without leases or receipts among commonly owned and controlled motor carriers, provided the driver carries and produces, upon demand of a Federal, State, or local law enforcement official, a summary document listing certain information [
Section 390.301(b)(3) provides that passenger-carrying CMVs may be exchanged or interchanged without leases or receipts among motor carriers that are party to a revenue pooling agreement approved by the Surface Transportation Board (STB) provided that the driver carries and, upon demand of a Federal, State, or local law enforcement official, displays other information, including a summary document [
Neither the 2016 NOI nor the 2017 proposal addressed the summary document requirements.
In its request for an extension of time, Coach USA argued that the information required in § 390.301(b)(2)(i) is trip specific, and would require the company to create a new summary document for each of more than 10,000 trips annually. Such a document would impose an unnecessary regulatory burden. Coach USA requested that the summary document required by this provision include only a “listing of all members of the corporate family along with their USDOT numbers, business addresses and contact telephone numbers.” The company also asked the Agency to clarify that any summary document may be maintained in electronic format and stored on an electronic logging device.
In its response to the Agency's 2017, proposal, Coach USA, like other industry commenters, reiterated its previous comments.
FMCSA proposes removing and reserving subpart F of part 390, moving it to subpart G with the same title,
The Agency proposes to revise the definition of
The definition of
Section 390.21 (suspended) and 390.21T would be returned nearly to the form before the March 27, 2015, final rule. FMCSA would remove the special marking regulations for leased and interchanged passenger-carrying CMVs in paragraph (f). Section 390.21 (suspended) and 390.21T would be revised to treat leased passenger-carrying CMVs like all other rented CMVs. For a lease of 30 calendar days or less, the lessee can opt to mark the vehicle with either the lessee's information or the lessor's information. However, the latter would require a fully executed copy of the lease be carried on the vehicle.
If the motor carrier is operating a passenger-carrying CMV under a lease or rental agreement for more than 30 calendar days, such CMV must be marked with the lessee's identification information. In a lease situation, the operating motor carrier is the lessee. These revised regulations would address petitioners' concerns that there is no easy way to display a temporary marking on certain passenger-carrying motor vehicles for short term leases. FMCSA specifically requests comments from State Agencies that participate in the Motor Carrier Safety Assistance Program about the effectiveness of these proposed marking regulations for leased passenger-carrying CMVs and any potential inspection or enforcement problems.
The general applicability section would be revised slightly to reflect the removal of exceptions in paragraph (b). Section 390.401(b) would be modified in several ways. First, a new exception would appear in paragraph (b)(1) to exclude from the rule contracts and agreements between passenger carriers with active operating authority when one such carrier acquires transportation services from another such carrier. Second, the current exception for financial leases in paragraph § 390.301(b)(1) would be moved to paragraph § 390.401(b)(2) as an exception with a revision. The provision that the financial organization, manufacturer, or dealer must not be a motor carrier to utilize the exception from the rule is proposed for removal because such entities are motor carriers when they move their vehicle inventory between business locations before purchases. Third, the limited exception in paragraph (b)(2) for passenger-carrying CMVs exchanged or interchanged between or among commonly owned and controlled motor carriers would be removed. Fourth, the limited exception in paragraph (b)(3) for passenger-carrying CMVs exchanged or interchanged between or among motor carriers that are a party to a revenue pooling agreement approved by the STB in accordance with 49 U.S.C 14302 would also be removed.
Lease and interchange requirements would be revised by removing § 390.303(a)(1)(iii), which covers written agreements governing the renting, borrowing, loaning, or similar transfer of a passenger-carrying CMV from another party. The rule would be revised and moved to § 390.403(a)(1) to include such transactions as either a lease or interchange, which makes paragraph (a)(1)(iii) unnecessary. FMCSA is proposing to expand the emergency-related exception in § 390.303(a)(2) (after transferring it to § 390.403(a)(2)) that allows the postponement of the completion of a lease for up to 48 hours for situations, such as a crash or vehicle breakdown, when a replacement vehicle must be immediately obtained from another motor carrier. Industry commenters requested this expansion of the limited exception and FMCSA agrees with them. FMCSA proposes to allow the exception even when passengers are not on the bus.
Section 390.403(b) specifies the contents of lease and interchange documents. This paragraph requires the lease, interchange agreement, or other agreement to contain: (1) The name of the vehicle manufacturer, the year of manufacture, and the last 6 digits of the Vehicle Identification Number; (2) the legal names, contact information, and signatures
Current § 390.303(b)(4)(i)-(iii) is a slightly revised version of 49 CFR 376.12(c)(1), (2) and (4). Paragraph (b)(4)(i) is essential because it sets forth the basic reason for a lease, from FMCSA's point of view, to assign full responsibility for regulatory compliance to the lessee. FMCSA proposes to make this paragraph more concise. Current paragraph (b)(4)(ii) would be moved to § 390.403(b)(4)(ii) and would retain only the last sentence of that provision. Paragraph (b)(4)(iii) is a useful disclaimer, should the issue of status of the lessor (contractor or employee) arise in a tax context, but FMCSA does not believe it is essential. Therefore, FMCSA proposes to shorten paragraphs (b)(4)(i) and (b)(4)(ii) and remove paragraph (b)(4)(iii).
FMCSA proposes to remove the requirement in § 390.303(b)(5) that the lease contain a statement that the lessee is responsible for compliance with the
Section 390.303(c) and (d) would be merged and made more concise. Revised § 390.403(c) would state that a copy of the lease must be carried in the passenger-carrying CMV during the period of the lease or interchange agreement. Both the lessee and lessor would retain the lease or interchange agreement for 1 year afterwards.
Section 390.303(e) would be removed. FMCSA has decided it does not need receipts when vehicles are surrendered to the lessee and returned to the lessor. If FMCSA or another government enforcement agency sought to assign a safety incident to the lessee or the lessor based on a lease or other agreement that had already been terminated, the former parties to the lease would have to decide how to document that premature termination.
FMCSA proposes to remove the requirements in § 390.303(f) for additional temporary markings of leased and interchanged passenger-carrying CMVs, and to return to the text of the marking rule in § 390.21(e)
FMCSA believes that this eliminates one of petitioners' major objections to the 2015 final rule. The proposed rule would require a leased passenger-carrying CMV be marked with the lessee's identification information if the lease is longer than 30 days. Leased passenger-carrying CMVs would be required to be marked with either the lessor's or lessee's identification information if the lease is 30 days or less.
Finally, the proposed rule removes the requirement in § 390.305 to notify the passenger group or their representative within 24 hours after the primary contractor reassigns the transportation to a subcontractor.
The following examples illustrate the proposed application of this rulemaking:
Authorized carrier A is contracted to transport a tour or travel group on a trip, but finds itself without the capacity to accommodate the group. Carrier A completely transfers the contract to authorized carrier B that has the necessary capacity. Carrier A may or may not pay a fee to carrier B for taking over the contract. A complete transfer would require carrier A to cancel its contract with the customer and carrier B to create a new contract with the customer. The proposed rule would not apply to these transactions because these transactions do not qualify as a “lease” (or interchange), as defined in § 390.5, of a passenger-carrying CMV.
Authorized carrier A lacks the capacity to execute a contracted trip and hires authorized carrier B to make the trip while maintaining its contract with the customer. This arrangement is documented by a charter contract between carriers A and B. Carrier A pays carrier B for the trip. This arrangement is not a lease, first because carrier B is not granting the use of a passenger-carrying CMV to carrier A, and second because both carriers are authorized carriers. Instead, carrier B is making the trip in its own name, on its own authority, with its own vehicles and is therefore responsible for compliance with the FMCSRs. The proposed rule therefore would not apply to this arrangement.
Assuming the same facts as described above, except that authorized carrier A provides some of the transportation service while contracting with authorized carrier B for the remainder, this arrangement is not a lease, first because carrier B is not granting the use of a passenger-carrying CMV to carrier A, and second because both carriers are authorized carriers. Carrier A pays carrier B for the transportation service as part of a charter contract. Carrier B is not surrendering control of a passenger-carrying CMV to carrier A for its own use. Both carriers are authorized carriers providing transportation in their own name, on their own authority, with their own vehicles, and each is independently responsible for compliance with the FMCSRs.
Authorized carrier A, which provides regular route passenger transportation services according to a fixed schedule, finds itself without the capacity to execute a route. Carrier A hires authorized carrier B to continue this service. This arrangement is documented by a charter contract between carriers A and B. Carrier A pays carrier B for the transportation service. This arrangement is not a lease, first because carrier B is not granting the use of a passenger-carrying CMV to carrier A, and second because both carriers are authorized carriers. This arrangement is also not an interchange because carriers A and B are not conducting a through movement. The proposed rule would not apply to this arrangement. Carrier B will conduct the transportation in its own name, on its own authority, with its own vehicle(s), and is therefore responsible for compliance with the FMCSRs.
Carrier A is exempt under 49 U.S.C. 13506 from the requirement for operating authority—for example, because of the hotel exemption in section 13506(a)(3)
Private motor carrier of passengers A finds itself without the capacity to transport the members of its organization. Carrier A therefore hires authorized carrier B to provide charter passenger transportation of the group in whole or in part. This arrangement is documented by a charter contract between carriers A and B. Carrier A pays carrier B for the transportation service. Carrier A is not a lessee and the arrangement is not a lease or interchange because carrier B conducts the transportation in its own name, on its own authority, with its own vehicle(s) and is therefore responsible for compliance with the FMCSRs. The
Carrier A is an exempt for-hire motor carrier of passengers (under 49 U.S.C. 13506) that finds itself without the capacity to accommodate a group it originally intended to transport. Carrier A uses a passenger-carrying CMV owned by authorized carrier B. This transaction is a lease under the proposed rule and would be subject to its requirements because carrier A is not authorized to operate for-hire in interstate commerce. In this case, carrier B is a lessor that is surrendering control of a passenger-carrying CMVs to carrier A for the use of that carrier. Carrier A will conduct the transportation in its own name under its own safety registration (
Private motor carrier of passengers A finds itself without the capacity to accommodate a group it originally intended to transport. Carrier A uses a passenger-carrying CMV owned by authorized carrier B. This transaction is a lease under the proposed rule and would be subject to its requirements because carrier A is not authorized to operate for-hire in interstate commerce. In this case, carrier B is a lessor that is surrendering control of a passenger-carrying CMVs to carrier A for the use of that carrier. Carrier A will conduct the transportation in its own name under its own safety registration (
Authorized carrier A lacks the capacity to execute a contracted trip and uses a passenger-carrying CMV owned by private motor carrier of passengers, carrier B. This transaction is a lease under the proposed rule and would be subject to its requirements because private carrier B is not authorized to operate for-hire in interstate commerce and cannot be hired to provide transportation. In this case, carrier B is a lessor that is surrendering control of its passenger-carrying CMV to carrier A. Carrier A will conduct the transportation in its own name, under its own authority, with the CMV leased from the private motor carrier of passengers, with or without drivers provided by carrier B, and is therefore responsible for compliance with the FMCSRs.
Private motor carrier of passengers A finds itself without the capacity to transport the members of its organization and uses a passenger-carrying CMV owned by private motor carrier of passengers B. This transaction is a lease under the proposed rule and would be subject to the requirements of this rule because neither carrier has the authority to conduct for-hire operations in interstate commerce. In this case, carrier B is a lessor that is surrendering control of its passenger-carrying CMV to carrier A for the use of that carrier. Carrier A will conduct the transportation in its own name, under its own safety registration (
For-hire passenger carrier A had its operating authority revoked for lack of adequate insurance coverage. Carrier A wishes to generate revenue from its otherwise idle CMVs. It therefore negotiates an arrangement with authorized carrier B to surrender control of its passenger-carrying CMVs to carrier B for a fee. This arrangement is a lease under the proposed rule and would be subject to its requirements because carrier A is not authorized to operate for-hire in interstate commerce. In this case, carrier A is simply a lessor. Carrier B would conduct the transportation in its own name, on its own authority, with the CMVs leased from carrier A, with or without drivers provided by carrier A, and is therefore responsible for compliance with the FMCSRs.
FMCSA requests comments to identify other methods to achieve the safety objectives of this rulemaking.
The FMCSRs, and any exceptions to the FMCSRs, apply only within the United States (and, in some cases, United States territories). Motor carriers and drivers are subject to the laws and regulations of the countries in which they operate, unless an international agreement states otherwise. Drivers and carriers should be aware of the regulatory differences among nations.
Section 390.5 (suspended) and 390.5T would be amended to revise the definitions of
Section 390.21 (suspended) and 390.21T would be returned nearly to the form before the March 27, 2015, final rule. In the paragraph (e) header, FMCSA replaces “Rented property-carrying commercial motor vehicles” with the header phrase
In paragraph (f), FMCSA would remove the special marking regulations for leased and interchanged passenger-carrying CMVs. This proposal would redesignate paragraphs (g) and (h) as paragraphs (f) and (g), respectively, as they were on July 1, 2015.
Subpart F, including §§ 390.301, 390.303, and 390.305, would be removed and reserved.
Subpart G, consisting of §§ 390.401 and 390.403, would be added.
Paragraph (a) would add the general applicability for passenger-carrying CMV leases and interchanges as the terms “lease” and “interchange” would be defined in this proposal's §§ 390.5 (suspended) and 390.5T.
Paragraph (b) would provide the two proposed exceptions to the general rule. Paragraph (c) would provide that if the use of a passenger-carrying commercial motor vehicle is conferred between motor carriers subject to this proposal and either carrier fails to meet all applicable requirements of subpart G, both motor carriers shall be subject to a civil penalty.
In paragraph (a)(1), this proposal would set out the two instances in which a lease or other agreement is required (and the lease or agreement must then meet the conditions of paragraphs (b) and (c) of this section). In paragraph (a)(2), this proposal would allow the delayed writing of a lease after an emergency, such as a disabled vehicle, that disrupts or delays a trip, and would not limit the exception to times when passengers are on the bus.
Paragraph (b) would specify the four minimum required items of any lease, sublease, or interchange document required under this proposal: (1)
Paragraph (c) would provide when a copy of the lease must be on the passenger-carrying CMV and how long both the lessor and lessee must retain copies of the lease, sublease, or agreement.
FMCSA performed an analysis of the impacts of the proposed rule and determined it is not a significant regulatory action under section 3(f) of E.O. 12866 (58 FR 51735, October 4, 1993), Regulatory Planning and Review, as supplemented by E.O. 13563 (76 FR 3821, January 21, 2011), Improving Regulation and Regulatory Review. Accordingly, the Office of Management and Budget (OMB) has not reviewed it under that Order. It is also not significant within the meaning of DOT regulatory policies and procedures (DOT Order 2100.5 dated May 22, 1980; 44 FR 11034 (February 26, 1979)).
As described earlier, the proposed rule would reduce the scope of the lease and interchange requirements for motor carriers of passengers. Furthermore, those passenger carriers and passenger-carrying CMV trips for which the proposed rule would remain applicable would be subject to lease and interchange requirements that are reduced in comparison to those of the 2015 final rule. At the same time, FMCSA believes that the lease and interchange requirements of the proposed rule would still enable safety officials and the general public to sufficiently identify the passenger carrier responsible for safety. As a consequence, FMCSA estimates that the proposed rule would result in a cost savings, but would not result in any change to safety benefits.
The Agency estimates that the proposed rule would result in a cost savings of $75.1 million on an undiscounted basis, $66.5 million discounted at 3 percent, and $57.5 million discounted at 7 percent over the 10-year analysis period. Expressed on an annualized basis, this equates to a 10-year cost savings of $7.8 million at a 3 percent discount rate and $8.2 million at a 7 percent discount rate, again representing a decrease in cost or a cost savings.
The proposed rule revises regulations established in the 2015 final rule, therefore the 2015 final rule serves as the baseline against which the effects of the proposed rule are evaluated. Many of the key inputs to this analysis of the proposed rule are based on the same data sources and methods as those developed and used in the evaluation of the 2015 final rule, with various updates made as needed to reflect more recently available data and information. Therefore, a copy of the regulatory evaluation for the 2015 final rule is available in the docket for the proposed rule, and, where applicable, the Agency cites that document in the analysis below.
The Agency estimates that an annual average of 8,215 motor carriers of passengers would experience regulatory relief under the proposed rule, as discussed below. This represents the average over the 10-year analysis period of the individual annual estimates of the total number of passenger carriers experiencing regulatory relief under the proposed rule, which are presented in Table 2. As also shown in Table 2, the Agency estimates that approximately 75 percent of this total number of passenger carriers would experience full regulatory relief and would no longer be subject to the lease and interchange requirements for passenger-carrying CMVs as a consequence of the proposed rule. The remaining 25 percent of these passenger carriers would experience partial regulatory relief and remain subject to reduced lease and interchange requirements compared to those of the 2015 final rule.
To derive the estimates presented in Table 2 of the number of passenger carriers experiencing regulatory relief under the proposed rule, FMCSA first estimated the number of passenger carriers that, in the absence of the proposed rule, would be affected by the lease and interchange requirements of the 2015 final rule. This estimate is based on the same data sources and methods as those developed and used in the evaluation of the 2015 final rule
Of this total population, the Agency estimates that, in the absence of the proposed rule, 7,774 of these passenger carriers would be subject to the May 2015 final rule. This estimate is based on the same methods as those developed and used in the evaluation of the 2015 final rule, and assumes that under that rule 100 percent of authorized for-hire carriers, 100 percent of exempt for-hire carriers, and 10 percent of private passenger carriers would be subject to the lease and interchange requirements for passenger-carrying CMVs.
The 2017 value of 7,774 passenger carriers that would be subject to the 2015 final rule was then used as the basis to develop future projections over the 2019 to 2028 analysis period. These projections were developed by increasing the baseline 2017 value of 7,774 passenger carriers consistent with the occupation-specific employment growth projections for Standard Occupational Classification (SOC) Code 53-3021 (Bus drivers, transit and intercity) obtained from the Bureau of Labor Statistics (BLS) Employment Projections Program which, from 2016 to 2026, is forecast to grow by 0.85 percent annually.
Table 2 also shows the subset of those 8,215 passenger carriers that under the proposed rule would experience full regulatory relief and would no longer be subject to lease and interchange requirements. Over the 10-year analysis period, the Agency estimates that an annual average of 6,161 passenger carriers, or approximately 75 percent of the total number of carriers that would experience regulatory relief, would experience full regulatory relief. This value was estimated by assuming that approximately 10 percent of authorized for-hire carriers would be subject to the lease and interchange requirements under the proposed rule, rather than 100 percent as assumed previously under the 2015 final rule and as shown in Table 3.
For exempt for-hire carriers and private passenger carriers, the analysis assumes that 100 percent and 10 percent, respectively, of these carriers would continue to be subject to the lease and interchange requirements under the proposed rule, the same percentages as under the 2015 final rule and also as shown in Table 3. Combined, these changes result in an estimated overall reduction of approximately 75 percent in the number of passenger carriers subject to lease and interchange requirements under the proposed rule.
Finally, Table 2 also presents an estimate of the remaining subset of the annual average of 8,215 passenger carriers that would experience partial regulatory relief and remain subject to reduced lease and interchange requirements compared to those of the 2015 rule. Over the 10-year analysis period, the Agency estimates that an annual average of 2,054 passenger carriers, or approximately 25 percent of the total, would experience partial regulatory relief. As noted earlier, however, these carriers would be subject to reduced requirements compared to those of the 2015 final rule.
FMCSA requests comments and submission of quantitative or qualitative data addressing the potential number of passenger carriers that would experience regulatory relief under the proposed rule.
The Agency estimates that an annual average of 537,134 passenger-carrying CMV trips would experience regulatory relief under the proposed rule over the 10-year analysis period, as presented in Table 4 and discussed below. This estimate is based on the same methods as those developed and used in the evaluation of the 2015 final rule.
The Agency estimates that approximately 75 percent of these passenger-carrying CMV trips would experience full regulatory relief and would no longer be subject to the lease and interchange requirements of the 2015 final rule. The remaining 25 percent of these trips would experience partial regulatory relief and remain subject to reduced lease and interchange requirements compared to those of the 2015 final rule.
FMCSA requests comments and submission of quantitative or qualitative data addressing the potential number of passenger-carrying CMV trips that would experience regulatory relief under the proposed rule.
The opportunity cost of the time employees of passenger carriers spend complying with the lease and interchange requirements represents approximately 95 percent of the total cost of the 2015 final rule. The cost savings from the proposed rule are likewise heavily influenced by aggregate changes in the opportunity cost of employee time.
The Agency evaluates changes in employee opportunity cost by using their labor costs. Labor costs comprise wages, fringe benefits, and overhead. Fringe benefits include paid leave, bonuses and overtime pay, health and other types of insurance, retirement plans, and legally required benefits (Social Security, Medicare, unemployment insurance, and workers' compensation insurance). Overhead includes any expenses to a firm associated with labor that are not part of employees' compensation, and typically includes many types of fixed costs of managing a body of employees, such as management and human resource staff salaries or payroll services. The economic costs of labor to a firm, in this case a passenger carrier, include all forms of compensation and labor related expenses. For this regulatory evaluation, the costs of labor to the firm are calculated to include base wages and fringe benefits, plus overhead.
For the regulatory evaluation of both the 2015 final rule and this proposed rule, the median hourly base wage rate for the BLS SOC code 53-1031, “First-Line Supervisors of Transportation and Material-Moving Machine and Vehicle Operators,” is used as the basis for calculating the relevant cost of labor. For 2016, BLS reports an hourly base wage rate of $27.54 for this occupation.
BLS does not publish data on fringe benefits for specific occupations, but it does do so for broad industry groups in its Employer Costs for Employee Compensation (ECEC) publication. A fringe benefit rate of 57 percent (
Finally, for estimating overhead rates, the Agency used industry data gathered for the Truck Costing Model developed by the Upper Great Plains Transportation Institute, North Dakota State University.
Combined, the overall relevant cost of labor, including base wage rate, fringe benefits, and overhead, for passenger carriers that would experience regulatory relief under the proposed rule is $54.91 per hour.
The proposed rule would not result in any increase in costs. It revises the 2015 final rule, which serves as the baseline against which the effects of the proposed rule are evaluated. Absent the proposed rule, the Agency estimates
The estimated reduction of approximately 75 percent in the number of passenger carriers and CMV trips under the proposed rule is responsible for most of the annualized cost savings. The remaining cost savings are the result of reduced requirements for those approximately 25 percent of passenger carriers and CMV trips that would remain subject to the lease and interchange rules.
Under both the 2015 rule and the proposed rule, costs are organized into six major categories. Five are related to the requirements under § 390.303 of the 2015 rule, and include: One-time costs of lease negotiation; lease documentation costs; lease copying costs; lease receipt costs; and vehicle marking costs. The sixth cost category is related to the charter party notification requirement under § 390.305 of the 2015 rule.
One-time costs of lease negotiation under the proposed rule are calculated based on the number of CMV trips that would experience regulatory relief under the proposed rule for this cost category, the time expended by employees in negotiating the lease and developing the lease document, and the total labor cost of these employees. The number of trips that would experience regulatory relief under the proposed rule for this cost category are the trips that would no longer be subject to the lease and interchange requirements. As presented earlier in Table 4, the Agency estimates that an annual average of 402,851 passenger-carrying CMV trips would no longer be subject to the lease and interchange requirements. Consistent with the approach used in the 2015 regulatory evaluation, for each of these trips it is assumed that 30 minutes of employee time is saved, for both the lessor and the lessee, for a total time savings of one hour for each such trip.
Lease documentation costs under the proposed rule are calculated based on the number of CMV trips that would experience regulatory relief under the proposed rule for this cost category, the time spent by carrier employees verifying the information and signing the lease, and the total labor cost of these employees. The number of trips that would experience regulatory relief under the proposed rule for this cost category are the same as above, an annual average of 402,851 trips that would no longer be subject to the lease and interchange requirements. Consistent with the 2015 regulatory evaluation, for each trip that would experience regulatory relief under the proposed rule for this cost category this analysis assumes that both the lessor and the lessee save 5 minutes of employee time, for a total savings of 10 minutes for each such trip.
Lease copying cost savings under the proposed rule are calculated based on the number of CMV trips that would experience regulatory relief under the proposed rule for this cost category, and an estimated cost per copy. The number of trips that would experience regulatory relief under the proposed rule for this cost category are the same as above, an annual average of 402,851 such trips. As in the 2015 regulatory evaluation, it assumed that for each trip one copy of the lease is made for the lessor and another for the lessee, each at a cost of $0.15, for a total cost of $0.30 per trip.
The remaining three cost categories (lease receipts, vehicle marking, and charter party notification) would be eliminated for all passenger carriers and passenger-carrying trips, including those that would still be subject to lease and interchange requirements under the proposed rule.
Lease receipt cost savings under the 2015 rule are calculated based on the number of CMV trips that would experience regulatory relief under the proposed rule for this cost category, with two receipts assumed per trip (one for obtaining, the other for surrendering the vehicle), and both the lessor and lessee requiring copies of each, for a total of four receipts per trip. Because the proposed rule would remove the receipt provision in its entirety, the cost savings would apply to all trips listed in Table 4, an annual average of 537,134 trips. Consistent with the 2015 regulatory evaluation, each receipt is assumed to cost $0.15, with four receipts required for a total of $0.60 per trip.
Vehicle marking cost savings under the 2015 rule are calculated based on the number of CMV trips that would experience regulatory relief under the proposed rule for this cost category, and marking costs per vehicle that include two sheets of letter size paper per trip at $0.014 per sheet, plus $0.04 for
Charter party notification cost savings under the 2015 rule are calculated based on the number of CMV trips that would experience regulatory relief under the proposed rule for this cost category, and an estimated expenditure by passenger carrier employees of 5 minutes per notification.
In summary, and as presented in Table 5, the Agency estimates that the proposed rule would result in a cost savings of $75.1 million on an undiscounted basis, $66.5 million discounted at 3 percent, and $57.5 million discounted at 7 percent over the 10-year analysis period. Expressed on an annualized basis, this equates to a 10-year cost savings of $7.8 million at a 3 percent discount rate and $8.2 million at a 7 percent discount rate.
The regulatory evaluation for the 2015 final rule attempted to estimate the potential safety benefits of lease and interchange requirements,
The problem of insufficient data and empirical evidence noted in 2015 is still present today. Unlike regulations dealing with vehicle equipment or driver behaviors that can be clearly linked to reduced crashes and improved safety, both the 2015 final rule and this proposed rule affect safety less directly and immediately. Lease and interchange requirements for motor carriers of passengers improve the ability of the Agency to attribute the inspection, compliance, enforcement, and safety data collected by the Agency and its State partners to the correct motor carrier and driver, allowing FMCSA to more accurately identify unsafe carriers and initiate appropriate interventions. FMCSA believes that this proposed rule would be a less costly and burdensome regulatory approach than the 2015 final rule, yet would still enable safety officials and the general public to
FMCSA requests comments and submission of quantitative or qualitative data addressing the potential impacts to safety benefits from the proposed rule.
This rulemaking is expected to be an E.O. 13771 deregulatory action.
The Regulatory Flexibility Act of 1980 (RFA) (5 U.S.C. 601
The proposed rule would not result in any increase in costs or any increase in burden. The proposed rule would reduce the applicability of the lease and interchange requirements for motor carriers of passengers, resulting in a substantial reduction in the number of entities that would be subject to these requirements and a commensurate reduction in costs and burden experienced by these entities. Furthermore, for those motor carriers of passengers that would continue to be subject to the lease and interchange requirements under the proposed rule, the requirements would be reduced in comparison to the existing requirements. This would also result in a reduction in costs and burden experienced by these entities.
The regulated entities that would experience regulatory relief under the proposed rule include all of the passenger carriers that are subject to the existing lease and interchange requirements. Approximately 75 percent of this total number of passenger carriers would experience full regulatory relief, and would no longer be subject to lease and interchange requirements for passenger-carrying CMVs. The remaining 25 percent of these passenger carriers would experience partial regulatory relief and remain subject to reduced lease and interchange requirements compared to those of the 2015 final rule.
As presented earlier in Table 3 of the Regulatory Analyses section, as of 2017 there were an estimated 7,774 passenger carriers subject to the existing lease and interchange requirements, representing approximately 58 percent of all active interstate passenger carriers. As presented in Table 2, this population of passenger carriers is projected to increase slightly due to general baseline industry growth to 7,906 passenger carriers in 2019, the first year that the proposed rule is anticipated to be in effect. Therefore, it is estimated that 7,906 passenger carriers would experience regulatory relief under the proposed rule. The number of these 7,906 passenger carriers that are small entities is not directly known by FMCSA, and is therefore estimated below.
The U.S. Small Business Administration (SBA) defines the size standards used to classify entities as small. SBA establishes separate standards for each industry, as defined by the North American Industry Classification System (NAICS).
Data regarding the annual revenue earned by the estimated 7,906 passenger carriers that would experience regulatory relief under the proposed rule is not collected by FMCSA and is not otherwise available from other
Although FMCSA has determined that this proposed rule would have an impact on a substantial number of small entities, the Agency has determined that the impact on the small entities that would experience regulatory relief under the proposed rule would not be significant. The proposed rule would not result in any increase in costs or any increase in burden for passenger carriers that are small entities. The effect of the proposed rule would be a reduction in costs and burden, and would be entirely beneficial to the passenger carriers that are small entities. As discussed in the Regulatory Analyses section, the Agency estimates that the proposed rule would result in a total cost savings of $75.1 million on an undiscounted basis over the 10-year analysis period used for the regulatory evaluation, or $7.5 million on an annualized basis. As presented in Table 2, an annual average of approximately 8,215 passenger carriers would experience regulatory relief under the proposed rule over the same 10-year analysis period, 98 percent of which are estimated to be small entities. The annual cost savings per small carrier would therefore be at most $914 on average (potentially even somewhat less, given that approximately 2 percent of passenger carriers that would experience regulatory relief under the proposed rule are not small entities and therefore may represent a disproportionately larger share of the overall absolute cost savings because of the larger scale of their operations). For even the smallest of the small entities, those operating only one passenger vehicle, this $914 in annual savings represents only about one half of one percent of the estimated total annual revenues of $200,000 for a carrier with just one vehicle. Therefore, although FMCSA has determined that this proposed rule would have an impact on a substantial number of small entities, the Agency has also determined that the impact on these small entities would not be significant, and furthermore will be entirely beneficial.
Accordingly, pursuant to section 605(b) of the Regulatory Flexibility Act, 5 U.S.C. 605(b), I hereby certify that the proposed rule would not have a significant economic impact on a substantial number of small entities. FMCSA requests comments on this certification and on the analysis presented in support of it.
In accordance with section 213(a) of the Small Business Regulatory Enforcement Fairness Act of 1996, FMCSA wants to assist small entities in understanding this proposed rule so that they can better evaluate its effects and participate in the rulemaking initiative. If the proposed rule would affect your small business, organization, or governmental jurisdiction, and you have questions concerning its provisions or options for compliance, please consult the FMCSA point of contact, Ms. Loretta Bitner, listed in the
Small businesses may send comments on the actions of Federal employees who enforce or otherwise determine compliance with Federal regulations to the Small Business Administration's Small Business and Agriculture Regulatory Enforcement Ombudsman and the Regional Small Business Regulatory Fairness Boards. The Ombudsman evaluates these actions annually and rates each agency's responsiveness to small business. If you wish to comment on actions by employees of FMCSA, call 1-888-REG-FAIR (1-888-734-3247). The DOT has a policy regarding the rights of small entities to regulatory enforcement fairness and an explicit policy against retaliation for exercising these rights.
The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538) requires Federal agencies to assess the effects of their discretionary regulatory actions. In particular, the Act requires agencies to prepare a comprehensive written statement for any proposed or final rule that may result in the expenditure by State, local, and tribal governments, in the aggregate, or by the private sector, of $156 million (which is the value equivalent of $100 million in 1995, adjusted for inflation to 2015 levels) or more in any one year. Because this proposed rule would not result in such an expenditure, a written statement is not required. However, the Agency does discuss the costs and benefits of this
This proposed rule would amend two OMB-approved information collections titled “Commercial Motor Vehicle Marking Requirements,” OMB No. 2126-0054, and “Lease and Interchange of Vehicles,” OMB No. 2126-0056, under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). As defined in 5 CFR 1320.3(c), “collection of information” includes reporting, recordkeeping, monitoring, posting, labeling, and other, similar actions. The title and description of the information collections, a description of those who must collect the information, and an estimate of the total annual burden follow. The estimate covers the time for reviewing instructions, searching existing sources of data, gathering and maintaining the data needed, and completing and reviewing the collection.
The Agency's CMV marking regulations require freight-carrying commercial motor carriers, passenger-carrying commercial motor carriers, and intermodal equipment providers to display the USDOT number and the legal name or a single trade name of the carrier or intermodal equipment provider on their vehicles. The USDOT number is used to identify all motor carriers in FMCSA's registration and information systems. It is also used by States as the key identifier in the Performance and Registration Information Systems Management (PRISM) system, a cooperative Federal/State program that makes motor carrier safety a requirement for obtaining and maintaining CMV registration and privileges. Vehicle marking requirements are intended to ensure that FMCSA, the National Transportation Safety Board (NTSB), and State safety officials are able to identify motor carriers and correctly assign responsibility for regulatory violations during inspections, investigations, compliance reviews, and crash studies. These marking requirements also provide the public with beneficial information that could assist in identifying carriers for the purposes of commerce, complaints, or emergency notification.
The proposed rule would eliminate the existing requirement under 49 CFR 390.303(f) for the temporary marking of leased commercial passenger vehicles. The proposed rule would therefore amend the OMB-approved information collection titled “Commercial Motor Vehicle Marking Requirements,” OMB No. 2126-0054. In the currently approved information collection, the temporary marking of leased commercial passenger vehicles was assumed to have
The Agency's lease and interchange of vehicles regulations ensure that truck and bus carriers are identified (and in some cases protected) when they agree to lease their equipment and drivers to other carriers. These regulations also ensure that the government and members of the public can determine who is responsible for a CMV. Prior to these regulations, some equipment was leased without written agreements, leading to disputes and confusion over which party to the lease was responsible for charges and actions and, at times, who was legally responsible for the vehicle. These recordkeeping requirements enable the general public and investigators to identify the passenger carrier responsible for safety, and ensure that FMCSA, our State partners, and the NTSB are better able to identify the responsible motor carrier and therefore correctly assign regulatory violations to the appropriate carrier during inspections, investigations, compliance reviews, and crash studies.
The proposed rule would reduce the scope of the lease and interchange requirements for motor carriers of passengers. Furthermore, those passenger carriers and passenger-carrying CMV trips for which the proposed rule would remain applicable would be subject to lease and interchange requirements that are reduced from the current requirements. The applicability of the existing lease and interchange requirements for motor carriers of passengers under 49 CFR 390.301 would be revised, resulting in a substantial reduction of approximately 75% in the number of passenger carriers and passenger-carrying CMV trips that would be subject to the lease and interchange requirement for motor carriers of passengers. For those motor carriers of passengers that would remain subject to the lease and interchange requirements under the proposed rule, the existing requirements under 49 CFR 390.303(e) for lease receipt copies would be eliminated, and the existing requirements under 49 CFR 390.305 for charter party notification would also be eliminated.
The proposed rule would therefore amend the OMB-approved information collection titled “Lease and Interchange of Vehicles,” OMB No. 2126-0056. In the proposed revision to this information collection, there is substantial reduction in time burden due to program change from the currently approved information collection as a result of the proposed rule.
As required by the Paperwork Reduction Act of 1995 (44 U.S.C. 3507(d)), FMCSA will submit a copy of this proposed rule to OMB for its review of the collection of information.
FMCSA asks for public comment on the proposed collection of information to help us determine how useful the information is; whether it can help the Agency perform our functions better; whether it is readily available elsewhere; how accurate our estimate of the burden of collection is; how valid our methods for determining burden are; how FMCSA can improve the quality, usefulness, and clarity of the information; and how FMCSA can minimize the burden of collection.
A rule has implications for Federalism under Section 1(a) of E.O. 13132 if it has “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.” FMCSA determined that this proposal would not have substantial direct costs on or for States, nor would it limit the policymaking discretion of States. Nothing in this document preempts any State law or regulation. Therefore, this rule does not have sufficient Federalism implications to warrant the preparation of a Federalism Impact Statement.
This proposed rule meets applicable standards in sections 3(a) and 3(b)(2) of E.O. 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 (62 FR 19885, April 23, 1997), requires agencies issuing “economically significant” rules, if the regulation also concerns an environmental health or safety risk that an agency has reason to believe may disproportionately affect children, to include an evaluation of the regulation's environmental health and safety effects on children. The Agency determined this proposed rule is not economically significant. Therefore, no analysis of the impacts on children is required. In any event, the Agency does not anticipate that this regulatory action could in any respect present an environmental or safety risk that could disproportionately affect children.
FMCSA reviewed this proposed rule in accordance with E.O. 12630, Governmental Actions and Interference with Constitutionally Protected Property Rights, and has determined it would not effect a taking of private property or otherwise have taking implications.
Section 522 of title I of division H of the Consolidated Appropriations Act, 2005, enacted December 8, 2004 (Pub. L. 108-447, 118 Stat. 2809, 3268, 5 U.S.C. 552a note), requires the Agency to conduct a Privacy Impact Assessment (PIA) of a regulation that will affect the privacy of individuals. This proposed rule does not require the collection of any personally identifiable information.
The Privacy Act (5 U.S.C. 552a) applies only to Federal agencies and any non-Federal agency that receives records contained in a system of records from a Federal agency for use in a matching program. FMCSA has
The E-Government Act of 2002, Public Law 107-347, sec. 208, 116 Stat. 2899, 2921 (December 17, 2002), requires Federal agencies to conduct a PIA for new or substantially changed technology that collects, maintains, or disseminates information in an identifiable form. No new or substantially changed technology would collect, maintain, or disseminate information as a result of this rule. Accordingly, FMCSA has not conducted a privacy impact assessment.
The regulations implementing E.O. 12372 regarding intergovernmental consultation on Federal programs and activities do not apply to this program.
FMCSA has analyzed this proposed rule under E.O. 13211, Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use. The Agency has determined that it is not a “significant energy action” under that order because it is not a “significant regulatory action” likely to have a significant adverse effect on the supply, distribution, or use of energy. Therefore, it does not require a Statement of Energy Effects under E.O. 13211.
Executive Order 13783 directs executive departments and agencies to review existing regulations that potentially burden the development or use of domestically produced energy resources, and to appropriately suspend, revise, or rescind those that unduly burden the development of domestic energy resources.
This rule does not have tribal implications under E.O. 13175, Consultation and Coordination with Indian Tribal Governments, because it does not have a substantial direct effect 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.
The National Technology Transfer and Advancement Act (NTTAA) (15 U.S.C. 272 note) directs agencies to use voluntary consensus standards in their regulatory activities unless the agency provides Congress, through OMB, with an explanation of why using these standards would be inconsistent with applicable law or otherwise impractical. Voluntary consensus standards (
FMCSA analyzed this NPRM for the purpose of the National Environmental Policy Act of 1969 (42 U.S.C. 4321
FMCSA also analyzed this rule under section 176(c) of the Clean Air Act, as amended (CAA) (42 U.S.C. 7401
Highway safety, Intermodal transportation, Motor carriers, Motor vehicle safety, Reporting and recordkeeping requirements.
In consideration of the foregoing, FMCSA proposes to amend 49 CFR chapter III, subchapter B, part 390 to read as follows:
49 U.S.C. 504, 508, 31132, 31133, 31134, 31136, 31137, 31144, 31149, 31151, 31502; sec. 114, Pub. L. 103-311, 108 Stat. 1673, 1677; sec. 212 and 217, Pub. L. 106-159, 113 Stat. 1748, 1766, 1767; sec. 229, Pub. L. 106-159 (as added and transferred by sec. 4115 and amended by secs. 4130-4132, Pub. L. 109-59, 119 Stat. 1144, 1726, 1743; sec. 4136, Pub. L. 109-59, 119 Stat. 1144, 1745; secs. 32101(d) and 32934, Pub. L. 112-141, 126 Stat. 405, 778, 830; sec. 2, Pub. L. 113-125, 128 Stat. 1388; secs. 5403, 5518, and 5524, Pub. L. 114-94, 129 Stat. 1312, 1548, 1558, 1560; sec. 2, Pub. L. 115-105, 131 Stat. 2263; and 49 CFR 1.81, 1.81a, 1.87.
The revised text reads as follows:
The revised text reads as follows:
(e)
(1) The CMV is marked in accordance with the provisions of paragraphs (b) through (d) of this section; or
(2) Except as provided in paragraph (e)(2)(v), the CMV is marked as set forth in paragraph (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; and
(iii) The rental agreement or lease as applicable entered into by the lessor and the renting motor carrier or lessee conspicuously contains the following information:
(A) The name and complete physical address of the principal place of business of the renting motor carrier or lessee;
(B) The identification number issued to the renting motor carrier or lessee by 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, the following information may be shown in a 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”; and
(iv) The rental agreement or lease as applicable entered into by the lessor and the renting motor carrier or lessee is carried on the rental CMV or leased passenger-carrying CMV during the full term of the rental agreement or lease. See the property-carrying leasing regulations at 49 CFR part 376 and the passenger-carrying leasing regulations at subpart G of this part for information that should be included in all leasing documents.
(v)
The revision to read as follows:
(e)
(1) The CMV is marked in accordance with the provisions of paragraphs (b) through (d) of this section; or
(2) Except as provided in paragraph (e)(2)(v), the CMV is marked as set forth in paragraph (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; and
(iii) The rental agreement or lease as applicable entered into by the lessor and the renting motor carrier or lessee conspicuously contains the following information:
(A) The name and complete physical address of the principal place of business of the renting motor carrier or lessee;
(B) The identification number issued to the renting motor carrier or lessee by 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, the following information may be shown in a 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 or leased CMV”; and
(iv) The rental agreement or lease as applicable entered into by the lessor and the renting motor carrier or lessee is carried on the rental CMV or leased passenger-carrying CMV during the full term of the rental agreement or lease. See the property-carrying leasing regulations at 49 CFR part 376 and the passenger-carrying leasing regulations at subpart G of this part for information that should be included in all leasing documents.
(v)
(a)
(1) The lease of passenger-carrying commercial motor vehicles; and
(2) The interchange of passenger-carrying commercial motor vehicles between motor carriers.
(b)
(2)
(c)
Except as provided in § 390.401(b) of this section, a motor carrier may transport passengers in a leased or interchanged commercial motor vehicle only under the following conditions:
(a)
(i) A lease granting the use of the passenger-carrying commercial motor vehicle and meeting the conditions of paragraphs (b) and (c) of this section. The provisions of the lease shall be adhered to and performed by the lessee; or
(ii) An agreement meeting the conditions of paragraphs (b) and (c) of this section and governing the interchange of passenger-carrying commercial motor vehicles between motor carriers of passengers conducting service on a route or series of routes. The provisions of the interchange agreement shall be adhered to and performed by the lessee.
(2)
(b)
(1)
(2)
(3)
(4)
(ii) In the event of a sublease between motor carriers, all of the requirements of this section shall apply to a sublease.
(c)
(b) “Non-postal operator” means a private express carrier, freight forwarder, or other provider of services for the collection, transportation, and delivery of international documents and packages, other than a postal operator.
(c) “Postal operator” means a governmental or non-governmental entity officially designated by a Universal Postal Union (UPU) member country to operate postal services and to fulfill the related obligations arising out of the Acts of the UPU on its territory.
(d) “Terminal dues” means the rates or fees determined through the UPU and paid by the postal operator in the country of origin to the postal operator in the country of destination to compensate for costs incurred in the country of destination for processing, transportation, and delivery of international “letter post” items, which may include documents or goods and generally weigh up to 4.4 pounds.
The Congress has provided that the Secretary of State (Secretary), in concluding postal treaties, conventions, or other international agreements, shall, to the maximum extent practicable, take measures to encourage governments of other countries to make available to the United States Postal Service (USPS) and private companies a range of nondiscriminatory customs procedures that will fully meet the needs of all types of American shippers (39 U.S.C. 407(e)(3)).
The Congress has likewise directed that responsible officials shall apply the customs laws of the United States and all other laws relating to importation or exportation of goods in the same manner to shipments of goods that are competitive products of the USPS and to similar shipments by private companies (39 U.S.C. 407(e)(2)).
It is the policy of the United States to promote and encourage the development of an efficient and competitive global system that provides for fair and nondiscriminatory postal rates.
(b) It is in the interest of the United States to:
(c) Some current international postal practices in the UPU do not align with United States economic and national security interests:
(A) the United States, along with other member countries of the UPU, is in many cases not fully reimbursed by the foreign postal operator for the cost of delivering foreign-origin letter post items, which can result in substantial preferences for foreign mailers relative to domestic mailers;
(B) the current terminal dues rates undermine the goal of unrestricted and undistorted competition in cross-border delivery services because they disadvantage non-postal operators seeking to offer competing collection and outward transportation services for goods covered by terminal dues in foreign markets; and
(C) the current system of terminal dues distorts the flow of small packages around the world by incentivizing the shipping of goods from foreign countries that benefit from artificially low reimbursement rates.
(d) It shall be the policy of the executive branch to support efforts that further the policies in this memorandum, including supporting a system of unrestricted and undistorted competition between United States and foreign merchants. Such efforts include:
(A) fully reimburse the USPS for costs to the same extent as domestic rates for comparable services;
(B) avoid a preference for inbound foreign small packages containing goods that favors foreign mailers over domestic mailers; and
(C) avoid a preference for inbound foreign small packages containing goods that favors postal operators over private-sector entities providing transportation services.
(b) If negotiations at the UPU's September 2018 Second Extraordinary Congress in Ethiopia fail to yield reforms that satisfy the criteria set forth in subsection (a) of this section, the United States will consider taking any appropriate actions to ensure that rates for the delivery of inbound foreign packages satisfy those criteria, consistent with applicable law.
(b) The Secretary or his designee shall, consistent with 39 U.S.C. 407(b)(1), seek agreement on future Convention texts that comport with the policies of this memorandum in meetings of the UPU, including at the September 2018 Extraordinary Congress.
(c) No later than November 1, 2018, the Secretary shall submit to the President a report summarizing the steps being taken to implement this memorandum. If the Secretary determines that sufficient progress on reforms to promote compatibility of the Acts of the UPU with the policy of this memorandum is not being achieved, the Secretary shall include recommendations for future action, including the possibility of adopting self-declared rates.
(b) This memorandum shall be implemented consistent with applicable law and subject to the availability of appropriations.
(c) This memorandum 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) The Secretary is authorized and directed to publish this memorandum in the
(1) delegate to the Secretary of State the functions and authorities vested in the President by sections 4, 6, and 7 of the Reinforcing Education Accountability in Development (READ) Act, (Div. A, Public Law 115-56); and
(2) delegate to the Administrator of the United States Agency for International Development the functions and authorities vested in the President by section 5(c) of the READ Act.
| 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 |