Page Range | 16767-17076 | |
FR Document |
Page and Subject | |
---|---|
83 FR 16786 - Updating the Code of Federal Regulations | |
83 FR 17075 - Pan American Day and Pan American Week, 2018 | |
83 FR 16904 - Sunshine Act Meeting | |
83 FR 16768 - Airworthiness Directives; The Boeing Company Airplanes | |
83 FR 16906 - Sunshine Act Meetings | |
83 FR 16849 - Sunshine Act Meeting Notice | |
83 FR 16808 - Special Local Regulation; Monongahela River (MM 0.22), Allegheny River (MM 0.8), and Ohio River (0.8), Pittsburgh, PA. | |
83 FR 16895 - Agency Information Collection Activities: Entry/Immediate Delivery Application and ACE Cargo Release | |
83 FR 16855 - Open Commission Meeting, Tuesday, April 17, 2018 | |
83 FR 16853 - Information Collection Being Submitted for Review and Approval to the Office of Management and Budget | |
83 FR 16856 - Information Collection Being Reviewed by the Federal Communications Commission | |
83 FR 16913 - JP Rail, Inc. d/b/a Southern Railroad Company of New Jersey-Lease and Operation Exemption-Consolidated Rail Corporation | |
83 FR 16853 - Proposed Prospective Purchaser Agreement for the Manual Transmission of Muncie Site in Muncie, Indiana | |
83 FR 16836 - Third-Party Submissions and Protests | |
83 FR 16835 - Trademark Petitions | |
83 FR 16833 - Submission for OMB Review; Comment Request; “Public Key Infrastructure (PKI) Certificate Action Form” | |
83 FR 16834 - Submission for OMB Review; Comment Request; “Public Search Facility User ID and Badging” | |
83 FR 16852 - Request for Nominations for Mobile Sources Technical Review Subcommittee | |
83 FR 16767 - Common Crop Insurance Regulations; Cultivated Clam Crop Insurance Provisions | |
83 FR 16767 - Common Crop Insurance Regulations; California Avocado Crop Insurance Provisions | |
83 FR 16900 - U.S.-Korea FTA: Advice on Modifications to Duty Rates for Certain Motor Vehicles | |
83 FR 16780 - Safety Zone; Recurring Marine Events, Sector Key West, Florida | |
83 FR 16811 - Safety Zones; Coast Guard Sector Upper Mississippi River Annual and Recurring Safety Zones Update | |
83 FR 16778 - Safety Zone; Barge PFE-LB444, San Joaquin River, Blackslough Landing, CA | |
83 FR 16776 - Drawbridge Operation Regulation; Atlantic Intracoastal Waterway and Biscayne Bay, Miami, FL | |
83 FR 16868 - Pilot Meetings Program for Model-Informed Drug Development Approaches | |
83 FR 16858 - Agency Information Collection Activities: Proposed Collection; Comment Request | |
83 FR 16826 - Agenda and Notice of Public Meeting of the Rhode Island Advisory Committee | |
83 FR 16860 - Proposed Data Collection Submitted for Public Comment and Recommendations | |
83 FR 16774 - Employment of Military Resources in the Event of Civil Disturbances | |
83 FR 16843 - Environmental Management Site-Specific Advisory Board Chairs | |
83 FR 16851 - Calpine Mid-Merit II, LLC; Supplemental Notice That Initial Market-Based Rate Filing Includes Request for Blanket Section 204 Authorization | |
83 FR 16852 - Wheelabrator Millbury Inc.; Supplemental Notice That Initial Market-Based Rate Filing Includes Request for Blanket Section 204 Authorization | |
83 FR 16847 - Combined Notice of Filings | |
83 FR 16850 - Combined Notice of Filings #1 | |
83 FR 16842 - Environmental Management Site-Specific Advisory Board | |
83 FR 16842 - Agency Information Collection Extension | |
83 FR 16832 - Carbon and Certain Alloy Steel Wire Rod From Mexico: Final Results of Antidumping Duty Administrative Review and Final Determination of No Shipments; 2015-2016 | |
83 FR 16828 - Aluminum Extrusions From the People's Republic of China: Correction of Notification of Rescission, in Part; 2016 | |
83 FR 16829 - Certain New Pneumatic Off-the-Road Tires From the People's Republic of China: Final Results of Antidumping Duty Administrative Review and New Shipper Review; 2015-2016 | |
83 FR 16914 - Agency Information Collection Activities: Request for Comments for the Renewal of a Previously Approved Information Collection | |
83 FR 16918 - Qualification of Drivers; Exemption Applications; Diabetes | |
83 FR 16915 - Agency Information Collection Activities: Request for Comments for the Renewal of a Previously Approved Information Collection. | |
83 FR 16913 - Agency Information Collection Activities: Request for Comments for the Renewal of a Previously Approved Information Collection | |
83 FR 16905 - Notice of Intent To Seek Approval To Renew an Information Collection | |
83 FR 16862 - Medicare and Medicaid Program; Application From DNV GL-Healthcare (DNV GL) for Continued Approval of Its Hospital Accreditation Program | |
83 FR 16867 - Advisory Committees; Filing of Closed Meeting Reports | |
83 FR 16865 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; 513(g) Request for Information | |
83 FR 16903 - Agency Information Collection Activities; Proposed eCollection eComments Requested; Extension Without Change of a Currently-Approved Collection, Title II of the Americans With Disabilities Act of 1990/Section 504 of the Rehabilitation Act of 1973 Discrimination Complaint Form | |
83 FR 16901 - Importer of Controlled Substances Application: Clinical Supplies Management Holdings, Inc. | |
83 FR 16824 - Notice of Intent To Grant Exclusive License | |
83 FR 16899 - Agency Information Collection Activities; Well Control and Production Safety Training | |
83 FR 16894 - Approval of Intertek USA, Inc., as a Commercial Gauger | |
83 FR 16898 - Agency Information Collection Activities; Relief or Reduction in Royalty Rates | |
83 FR 16866 - Listing of Ingredients in Tobacco Products; Guidance for Industry; Availability | |
83 FR 16870 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Current Good Manufacturing Practices and Related Regulations for Blood and Blood Components; and Requirements for Donation Testing, Donor Notification, and “Lookback” | |
83 FR 16863 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Evaluation of the Fresh Empire Campaign on Tobacco | |
83 FR 16894 - Accreditation and Approval of Camin Cargo Control, Inc., as a Commercial Gauger and Laboratory | |
83 FR 16823 - Board for International Food and Agricultural Development; Notice of Meeting | |
83 FR 16920 - Proposed Information Collection; Comment Request | |
83 FR 16841 - Joint Rules of Appellate Procedure for Courts of Criminal Appeals; Proposed Changes | |
83 FR 16785 - State Advisory Councils | |
83 FR 16908 - Proposed Collection; Comment Request | |
83 FR 16908 - Submission for OMB Review; Comment Request | |
83 FR 16774 - Drawbridge Operation Regulation; Willamette River at Portland, OR | |
83 FR 16923 - Programmatic Consideration of Historic Properties in Transfer of Property Rights of Vacant and Underutilized Buildings, Structures and Land | |
83 FR 16775 - Drawbridge Operation Regulation; Lake Washington Ship Canal, Seattle, WA | |
83 FR 16774 - Drawbridge Operation Regulation; Hood Canal, Port Gamble, WA | |
83 FR 16776 - Drawbridge Operation Regulation; Willamette River, Portland, OR | |
83 FR 16913 - Eighty Eighth RTCA SC-147 Plenary Session Joint With EUROCAE WG-75 | |
83 FR 16921 - Agency Information Collection Activity: Pulmonary Health and Deployment to Southwest Asia and Afghanistan | |
83 FR 16924 - Agency Information Collection Activity: Application and Reporting Requirements To Receive Grants | |
83 FR 16925 - Agency Information Collection Activity: VA Health Professional Scholarship and Visual Impairment and Orientation and Mobility Professional Scholarship Programs | |
83 FR 16922 - Agency Information Collection Activity: VBA Call Center Satisfaction Survey | |
83 FR 16924 - Agency Information Collection Activity: Request for Change of Program or Place of Training | |
83 FR 16922 - Agency Information Collection Activity: Federal Medical Care Recovery Act Bill Requests | |
83 FR 16857 - Proposed Agency Information Collection Activities; Comment Request | |
83 FR 16839 - Request for Information Regarding the Bureau's Consumer Complaint and Consumer Inquiry Handling Processes | |
83 FR 16885 - Office of Tribal Self-Governance; Planning Cooperative Agreement | |
83 FR 16877 - Office of Tribal Self-Governance; Negotiation Cooperative Agreement | |
83 FR 16841 - Agency Information Collection Activities; Submission to the Office of Management and Budget for Review and Approval; Comment Request; Teacher Education Assistance for College and Higher Education Grant Program (TEACH Grant Program) Agreement To Serve | |
83 FR 16905 - Advisory Committee on Reactor Safeguards (ACRS); Meeting of the ACRS Subcommittee on Reliability and Probabilistic Risk Assessment; Notice of Meeting | |
83 FR 16906 - Advisory Committee on Reactor Safeguards (ACRS); Meeting of the ACRS Subcommittee on Planning and Procedures; Notice of Meeting | |
83 FR 16896 - 30-Day Notice of Proposed Information Collection: Mortgagor's Certificate of Actual Cost | |
83 FR 16897 - 30-Day Notice of Proposed Information Collection: Energy Efficient Mortgages (EEMs) | |
83 FR 16824 - Information Collection; Forest Products Removal Permits and Contracts | |
83 FR 16824 - Notice of Settlement Pursuant to CERCLA; Libby Asbestos Site, Lincoln County, MT | |
83 FR 16907 - Self-Regulatory Organizations; Nasdaq PHLX LLC; Order Approving a Proposed Rule Change, as Modified by Amendment Nos. 1, 2, and 3, To Adopt Protections for Butterfly Spreads and Box Spreads | |
83 FR 16909 - Self-Regulatory Organizations; NYSE Arca, Inc.; Notice of Filing and Immediate Effectiveness of Proposed Rule Change To Amend the NYSE Arca Equities Fees and Charges | |
83 FR 16876 - National Committee on Vital and Health Statistics: Meeting | |
83 FR 16847 - Notice of Petition for Declaratory Order; Marathon Pipe Line LLC, MPLX Ozark Pipe Line LLC | |
83 FR 16844 - Notice of Commissioner Attendance at House Committee on Energy and Commerce Hearing | |
83 FR 16847 - Notice of Intent To Prepare an Environmental Assessment for the Proposed Empire Pipeline, Inc. Empire North Project and Request for Comments on Environmental Issues | |
83 FR 16845 - Supplemental Notice of Technical Conference; Transmission Planning Within the California Independent System Operator Corporation; California Public Utilities Commission, Northern California Power Agency, City and County of San Francisco, State Water Contractors, Transmission Agency of Northern California v. Pacific Gas and Electric Company, Southern California Edison Company | |
83 FR 16806 - Bureau of Indian Education Standards, Assessments, and Accountability System Negotiated Rulemaking Committee Establishment; Proposed Membership | |
83 FR 16897 - Redelegation of Authority to the General Deputy Assistant Secretary for Administration | |
83 FR 16783 - United States Air Force 81st Security Forces Anti-Terrorism Office, Restricted Area, Keesler Air Force Base, Biloxi, Mississippi | |
83 FR 16893 - Office of the Secretary; Notice of Meetings | |
83 FR 16893 - National Institutes of Health | |
83 FR 16893 - National Institute of Dental and Craniofacial Research; Notice of Closed Meeting | |
83 FR 16892 - National Institute of Allergy and Infectious Diseases; Notice of Closed Meetings | |
83 FR 16892 - National Institute of Allergy and Infectious Diseases Notice of Closed Meetings | |
83 FR 16875 - Advisory Committee on Training in Primary Care Medicine and Dentistry | |
83 FR 16815 - Safety Zone; Lower Tchefuncte River, Madisonville, LA | |
83 FR 16817 - Safety Zone; Lower Mississippi River, New Orleans, LA | |
83 FR 16903 - Agency Information Collection Activities; Proposed eCollection, eComments Requested; Extension Without Change of a Previously Approved Collection; Application for Registration, Application for Registration Renewal, Affidavit for Chain Renewal; DEA Forms 225, 225a and 225b | |
83 FR 16902 - Agency Information Collection Activities; Proposed eCollection, eComments Requested; Extension Without Change of a Previously Approved Collection; Application for Registration, Application for Registration Renewal; DEA Forms 363, 363a | |
83 FR 16802 - Proposed Amendment of Class E Airspace; Lansing, MI | |
83 FR 16804 - Proposed Amendment of VOR Federal Airways V-170 and V-219 in the Vicinity of Fairmont, MN | |
83 FR 16827 - Notice of Public Meeting of the Oregon Advisory Committee to the U.S. Commission on Civil Rights | |
83 FR 16826 - Notice of Public Meeting of the Oregon Advisory Committee to the U.S. Commission on Civil Rights | |
83 FR 16827 - Notice of Public Meeting of the West Virginia Advisory Committee | |
83 FR 16828 - Agenda and Notice of Public Meeting of the District of Columbia Advisory Committee | |
83 FR 16843 - Sabine Pass Liquefaction, LLC; Application for Blanket Authorization To Export Previously Imported Liquefied Natural Gas on a Short-Term Basis | |
83 FR 16916 - Notice of Final Federal Agency Actions on Proposed Highways in Colorado | |
83 FR 16794 - Airworthiness Directives; General Electric Company CF34-8E Engines | |
83 FR 16796 - Airworthiness Directives; The Boeing Company Airplanes | |
83 FR 16819 - Endangered and Threatened Wildlife and Plants; 90-Day Findings for Two Species | |
83 FR 16799 - Airworthiness Directives; Airbus Airplanes | |
83 FR 16792 - Airworthiness Directives; Saab AB, Saab Aeronautics (Formerly Known as Saab AB, Saab Aerosystems) Airplanes | |
83 FR 16787 - Airworthiness Directives; Airbus Airplanes | |
83 FR 16930 - Patient Protection and Affordable Care Act; HHS Notice of Benefit and Payment Parameters for 2019 |
Agricultural Research Service
Federal Crop Insurance Corporation
Forest Service
International Trade Administration
Patent and Trademark Office
Engineers Corps
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
Indian Health Service
National Institutes of Health
Coast Guard
U.S. Customs and Border Protection
Bureau of Safety and Environmental Enforcement
Fish and Wildlife Service
Indian Affairs Bureau
Drug Enforcement Administration
Parole Commission
Federal Aviation Administration
Federal Highway Administration
Federal Motor Carrier Safety Administration
Internal Revenue Service
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.
To subscribe to the Federal Register Table of Contents electronic mailing list, go to https://public.govdelivery.com/accounts/USGPOOFR/subscriber/new, enter your e-mail address, then follow the instructions to join, leave, or manage your subscription.
Federal Crop Insurance Corporation, USDA.
Final rule with request for comments; correcting amendment.
This document contains necessary amendments to apply a technical correction to the final rule with request for comments for the Cultivated Clam Crop Insurance Provisions which published in the
Ron Lundine, Director, Product Management, Actuarial and Product Design Division, Risk Management Agency, United States Department of Agriculture, Beacon Facility, Stop 0812, Room 421, P.O. Box 419205, Kansas City, MO 64141-6205, telephone (816) 926-3854.
This technical correction is being published to remove section 15 of the “cultivated clam crop insurance provisions,” published December 27, 2017 (Docket No. FCIC-17-0003). Section 15 excludes the use of written agreements by not allowing the written agreement provisions in the Common Crop Insurance Policy Basic Provisions to apply. This provision was necessary when the program was a pilot program to ensure there were no changes made to the policy so that the existing terms would be evaluated to make sure they were actuarially sound and there were no program integrity issues. Once the pilot program is completed, evaluated, and approved for permanence, the restriction on written agreements is no longer necessary. As a result of the removal of section 15, FCIC is allowing the use of written agreements under the cultivated clam crop provisions and redesignating subtitle numbering from section 16 to section 15, section 17 to section 16, and section 18 to section 17.
Crop insurance, Cultivated clam, Reporting and recordkeeping requirements.
Accordingly, 7 CFR part 457 is corrected by making the following amendments:
7 U.S.C. 1506(l) and 1506(o).
Federal Crop Insurance Corporation, USDA.
Correcting amendment.
This document contains necessary amendments to apply a technical correction to the final rule with request for comments for the California Avocado Crop Insurance Provisions which published in the
Ron Lundine, Director, Product Management, Actuarial and Product Design Division, Risk Management Agency, United States Department of Agriculture, Beacon Facility, Stop 0812, Room 421, P.O. Box 419205, Kansas City, MO 64141-6205, telephone (816) 926-3854.
This technical correction is being published to remove section 13 of the “California avocado crop insurance provisions,” published December 27, 2017 (Docket No. FCIC-17-0002). Section 13 excludes the use of written agreements by not allowing the written agreement provisions in the Common Crop Insurance Policy Basic Provisions to apply. This provision was necessary when the program was a pilot program to ensure there were no changes made to the policy so that the existing terms would be evaluated to make sure they were actuarially sound and there were no program integrity issues. Once the pilot program is completed, evaluated, and approved for permanence, the restriction on written agreements is no longer necessary. As a result of the removal of section 13, FCIC is allowing the use of written agreements under the California avocado crop provisions and redesignating subtitle numbering from section 14 to section 13.
Crop insurance, California avocado, Reporting and recordkeeping requirements.
Accordingly, 7 CFR part 457 is corrected by making the following amendments:
7 U.S.C. 1506(l) and 1506(o).
Federal Aviation Administration (FAA), DOT.
Final rule; request for comments.
We are adopting a new airworthiness directive (AD) for The Boeing Company Model 787-8 and 787-9 airplanes powered by Rolls-Royce plc (RR) Trent 1000-A2, Trent 1000-AE2, Trent 1000-C2, Trent 1000-CE2, Trent 1000-D2, Trent 1000-E2, Trent 1000-G2, Trent 1000-H2, Trent 1000-J2, Trent 1000-K2, and Trent 1000-L2 turbofan engines. This AD requires revising the airplane flight manual to limit extended operations (ETOPS). This AD was prompted by a report from the engine manufacturer indicating that after an engine failure, prolonged operation at high thrust settings on the remaining engine during an ETOPS diversion may result in failure of the remaining engine before the diversion can be safely completed. We are issuing this AD to address the unsafe condition on these products.
This AD is effective April 17, 2018.
We must receive comments on this AD by June 1, 2018.
You may send comments, using the procedures found in 14 CFR 11.43 and 11.45, by any of the following methods:
•
•
•
•
You may examine the AD docket on the internet at
Tak Kobayashi, Aerospace Engineer, Propulsion Section, FAA, Seattle ACO Branch, 2200 South 216th Street, Des Moines, WA 98198; phone and fax: 206-231-3553; email:
Over the past year, we have been aware of several engine failures of Trent 1000 Package C engines due to failed compressor and turbine blades and seals. Package C engines are Rolls-Royce plc (RR) Trent 1000-A2, Trent 1000-AE2, Trent 1000-C2, Trent 1000-CE2, Trent 1000-D2, Trent 1000-E2, Trent 1000-G2, Trent 1000-H2, Trent 1000-J2, Trent 1000-K2, and Trent 1000-L2 turbofan engines. During that same period, under the management programs for those engine issues, we have been aware of numerous reports of engine inspection findings of cracked blades resulting in unscheduled engine removals. Boeing reported to the FAA that the engine manufacturer recently determined that intermediate pressure compressor (IPC) stage 2 blades have a resonant frequency that is excited by the airflow conditions existing in the engine during operation at high thrust settings under certain temperature and altitude conditions. The resultant blade vibration can result in cumulative fatigue damage that can cause blade failure and consequent engine shutdown. In the event of a single engine in-flight shutdown during the cruise phase of flight, thrust on the remaining engine is normally increased to maximum continuous thrust (MCT). During a diversion following a single engine shutdown under an ETOPS flight, the remaining engine may operate at MCT for a prolonged period, under which the IPC stage 2 blades would be exposed to the resonant frequency condition. Therefore, an ETOPS diversion will put the remaining engine at an operating condition that would significantly increase the likelihood of failure of the remaining engine. In addition, if the remaining engine already had cracked IPC stage 2 blades, the likelihood of the remaining engine failing will further increase before a diversion can be safely completed.
We are issuing this AD because we evaluated all the relevant information and determined the unsafe condition described previously is likely to exist or develop in other products of the same type design.
This AD requires revising the AFM to limit ETOPS operation.
This AD is interim action. The manufacturer is currently developing a modification that will address the unsafe condition identified in this AD. Once this modification is developed, approved, and available, we might consider additional rulemaking.
An unsafe condition exists that requires the immediate adoption of this AD without providing an opportunity for public comments prior to adoption. The FAA has found that the risk to the flying public justifies waiving notice and comment prior to adoption of this rule because unrecoverable thrust loss on both engines could lead to a forced landing. Therefore, we find good cause that notice and opportunity for prior public comment are impracticable. In addition, for the reasons stated above, we find that good cause exists for making this amendment effective in less than 30 days.
This AD is a final rule that involves requirements affecting flight safety and was not preceded by notice and an opportunity for public comment. However, we invite you to send any written data, views, or arguments about this final rule. Send your comments to an address listed under the
We will post all comments we receive, without change, to
We estimate that this AD affects 14 airplanes of U.S. registry. We estimate the following costs to comply with this AD:
Title 49 of the United States Code specifies the FAA's authority to issue rules on aviation safety. Subtitle I, section 106, describes the authority of the FAA Administrator. “Subtitle VII: Aviation Programs” describes in more detail the scope of the Agency's authority.
We are issuing this rulemaking under the authority described in Subtitle VII, Part A, Subpart III, Section 44701: “General requirements.” Under that section, Congress charges the FAA with promoting safe flight of civil aircraft in air commerce by prescribing regulations for practices, methods, and procedures the Administrator finds necessary for safety in air commerce. This regulation is within the scope of that authority because it addresses an unsafe condition that is likely to exist or develop on products identified in this rulemaking action.
This AD is issued in accordance with authority delegated by the Executive Director, Aircraft Certification Service, as authorized by FAA Order 8000.51C. In accordance with that order, issuance of ADs is normally a function of the Compliance and Airworthiness Division, but during this transition period, the Executive Director has delegated the authority to issue ADs applicable to transport category airplanes and associated appliances to the Director of the System Oversight Division.
This AD will not have federalism implications under Executive Order 13132. This AD will not have a substantial direct effect on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government.
For the reasons discussed above, I certify that this AD:
(1) Is not a “significant regulatory action” under Executive Order 12866,
(2) Is not a “significant rule” under DOT Regulatory Policies and Procedures (44 FR 11034, February 26, 1979),
(3) Will not affect intrastate aviation in Alaska, and
(4) Will not have a significant economic impact, positive or negative, on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.
Air transportation, Aircraft, Aviation safety, Incorporation by reference, Safety.
Accordingly, under the authority delegated to me by the Administrator, the FAA amends 14 CFR part 39 as follows:
49 U.S.C. 106(g), 40113, 44701.
This AD is effective April 17, 2018.
None.
This AD applies to The Boeing Company Model 787-8 and 787-9 airplanes, certificated in any category, powered by Rolls-Royce plc (RR) Trent 1000-A2, Trent 1000-AE2, Trent 1000-C2, Trent 1000-CE2, Trent 1000-D2, Trent 1000-E2, Trent 1000-G2, Trent 1000-H2, Trent 1000-J2, Trent 1000-K2, and Trent 1000-L2 turbofan engines.
Air Transport Association (ATA) of America Code 71, Power plant.
This AD was prompted by a report from the engine manufacturer indicating that after an engine failure, prolonged operation at high thrust settings on the remaining engine during an extended-operation (ETOPS) diversion may result in failure of the remaining engine before the diversion can be safely completed. We are issuing this AD to address unrecoverable thrust loss on both engines, which could lead to a forced landing.
Comply with this AD within the compliance times specified, unless already done.
Within 3 days after the effective date of this AD, revise the Certificate Limitations chapter of the applicable Boeing AFM Engine Appendix by incorporating the information in figure 1 to paragraph (g) of this AD. Where figure 1 to paragraph (g) of this AD refers to a “Trent 1000 2 engine,” this term means all engines identified in paragraph (c) of this AD. This may be accomplished by inserting a copy of this AD into the AFM. When information identical to that in figure 1 to paragraph (g) of this AD has been included in the Certificate Limitations chapter of the general revisions of the AFM, the general revisions may be inserted into the AFM, and the copy of this AD may be removed from the AFM.
Concurrently with accomplishment of the requirements of paragraph (g) of this AD, revise the Performance chapter of the applicable Boeing AFM Engine Appendix by incorporating the information in figure 2 to paragraph (h) of this AD. This may be accomplished by inserting a copy of this AD into the AFM. When information identical to that in figure 2 to paragraph (h) of this AD has been included in the Performance chapter of the general revisions of the AFM, the general revisions may be inserted into the AFM, and the copy of this AD may be removed from the AFM.
(1) The Manager, Seattle ACO Branch, FAA, has the authority to approve AMOCs for this AD, if requested using the procedures found in 14 CFR 39.19. In accordance with 14 CFR 39.19, send your request to your principal inspector or local Flight Standards District Office, as appropriate. If sending information directly to the manager of the certification office, send it to the attention of the person identified in paragraph (j) of this AD. Information may be emailed to:
(2) Before using any approved AMOC, notify your appropriate principal inspector, or lacking a principal inspector, the manager of the local flight standards district office/certificate holding district office.
(3) An AMOC that provides an acceptable level of safety may be used for any repair, modification, or alteration required by this AD if it is approved by the Boeing Commercial Airplanes Organization Designation Authorization (ODA) that has been authorized by the Manager, Seattle ACO Branch, to make those findings. To be approved, the repair method, modification deviation, or alteration deviation must meet the certification basis of the airplane, and the approval must specifically refer to this AD.
For more information about this AD, contact Tak Kobayashi, Aerospace Engineer, Propulsion Section, FAA, Seattle ACO Branch, 2200 South 216th Street, Des Moines, WA 98198; phone and fax: 206-231-3553; email:
None.
Under Secretary of Defense for Policy, DoD.
Final rule.
This final rule removes the Department of Defense (DoD) regulation regarding employment of military resources in the event of civil disturbances. The part contains uniform DoD policies, assigns responsibilities, and furnishes general guidance for utilizing DoD military and civilian personnel, facilities, equipment, or supplies in support of civil authorities during civil disturbances within the United States. This part is outdated and unnecessary; therefore, it may be removed from the CFR.
This rule is effective on April 17, 2018.
James (Coach) Ross at 571-256-8325.
It has been determined that publication of this CFR part removal for public comment is impracticable, unnecessary, and contrary to public interest since it is based on removing DoD internal policies and procedures that are publicly available on the Department's issuance website.
DoD internal guidance regarding employment of military resources in the event of civil disturbances will continue to be published in DoD Instruction 3025.21, “Defense Support of Civilian Law Enforcement Agencies,” available at
This rule is not significant under Executive Order (E.O.) 12866, “Regulatory Planning and Review,” therefore, E.O. 13771, “Reducing Regulation and Controlling Regulatory Costs” does not apply.
Armed forces, Civil disorders, Emergency powers, Intergovernmental relations, Law enforcement, Reporting and recordkeeping requirements, Security measures.
Coast Guard, DHS.
Notice of deviation from drawbridge regulation.
The Coast Guard has issued a temporary deviation from the operating schedule that governs three Multnomah County bridges: Broadway Bridge, mile 11.7, Morrison Bridge, mile 12.8, and Hawthorne Bridge, mile 13.1 crossing the Willamette River at Portland, OR. This deviation is necessary to accommodate the annual Cinco de Mayo half marathon event. The deviation allows the bridges to remain in the closed-to-navigation position.
This deviation is effective from 8 a.m. to 9:15 a.m. on May 6, 2018.
The docket for this deviation, USCG-2018-0326 is available at
If you have questions on this temporary deviation, call or email Mr. Steven Fischer, Bridge Administrator, Thirteenth Coast Guard District; telephone 206-220-7282, email
Multnomah County, the bridge owner, has requested a temporary deviation from the operating schedule for the Broadway Bridge, mile 11.7, Morrison Bridge, mile 12.8, and Hawthorne Bridge, mile 13.1, all three crossing the Willamette River at Portland, OR. The requested deviation is to accommodate the annual Cinco de Mayo half marathon event. The vertical clearances for theses bridges in the closed-to-navigation position are: Broadway Bridge provides 69 feet, Morrison Bridge provides 69 feet and Hawthorne Bridge provides 49 feet; all clearances are referenced to the vertical clearance above Columbia River Datum 0.0. The normal operating schedule for these bridges is 33 CFR 117.897. This deviation allows the Broadway Bridge, Morrison Bridge, and the Hawthorne Bridge to remain in the closed-to-navigation position, and need not open for maritime traffic from 8 a.m. to 9:15 a.m. on May 6, 2018.
Waterway usage on this part of the Willamette River includes vessels ranging from commercial tug and barge to small pleasure craft. Vessels able to pass through the subject bridges in the closed-to-navigation position may do so at any time. The bridges will be able to open for emergencies, and there is no immediate alternate route for vessels to pass. The Coast Guard will inform the users of the waterway, through our Local and Broadcast Notices to Mariners, of the change in operating schedule for the bridges so that vessels can arrange their transits to minimize any impact caused by the temporary deviation. In accordance with 33 CFR 117.35(e), the drawbridges must return to their regular operating schedules immediately at the end of the effective period of this temporary deviation. This deviation from the operating regulations is authorized under 33 CFR 117.35.
Coast Guard, DHS.
Notice of deviation from drawbridge regulation.
The Coast Guard has issued a temporary deviation from the operating schedule that governs the Washington State pontoon highway bridge (Hood Canal Bridge) across Hood Canal, mile 5.0, near Port Gamble, WA. The deviation is necessary to accommodate replacement of the draw span operating equipment. This deviation allows the bridge to open the draw half-way, 300 feet, after receiving at least a four hour notice.
This deviation is effective from 12:01 a.m. on May 1, 2018, to 11:59 p.m. on September 30, 2018.
The docket for this deviation, USCG-2018-0299 is available at
If you have questions on this temporary deviation, call or email Mr. Steven Fischer, Bridge Administrator, Thirteenth Coast Guard District; telephone 206-220-7282, email
The Washington Department of Transportation (WSDOT), the bridge owner, has requested a temporary deviation from the operating schedule of the Hood Canal Bridge. The request is for the subject bridge to be allowed to open half of the draw span to facilitate safe and uninterrupted draw span equipment replacement. The Hood Canal Bridge crosses Hood Canal, mile 5.0, near Port Gamble, WA. The bridge has two fixed spans (east and west), and one draw span (center). The east span provides 50 feet of vertical clearance, the west span provides 35 feet of vertical clearance, and the center span provides zero feet of vertical clearance in the closed-to-navigation position. The center span provides unlimited vertical clearance in the open-to-navigation position. Vertical clearances are referenced to mean high-water elevation.
This deviation allows the center span of the Hood Canal Bridge to open half-way (300 feet vice 600 feet) on signal after receiving at least a four hour notice from 12:01 a.m. on May 1, 2018, to 11:59 p.m. on September 30, 2018. During the period of this deviation, the drawbridge will not be able to operate according to the normal operating schedule. The normal operating schedule for the Hood Canal Bridge is in accordance with 33 CFR 117.1045. The bridge shall operate in accordance to 33 CFR 117.1045 at all other times. Waterway usage on this part of Hood Canal (Admiralty Inlet) includes commercial tugs and barges, U.S. Navy and U.S. Coast Guard vessels, and small pleasure craft. Coordination has been completed with known waterway users, and a no objections to the deviation have been received.
Vessels able to pass through the east and west spans may do so at any time. The center span does not provide passage in the closed-to-navigation position. The subject bridge will be able to open half the center span for Navy and Coast Guard vessels during emergencies, when at least a one hour notice has been given by the Department of the Navy or U.S. Coast Guard. The Coast Guard will also inform the users of the waterways through our Local and Broadcast Notices to Mariners of the change in operating schedule for the bridge so that vessels can arrange their transits to minimize any impact caused by this temporary deviation.
In accordance with 33 CFR 117.35(e), the drawbridge must return to its regular operating schedule immediately at the end of the effective period of this temporary deviation. This deviation from the operating regulations is authorized under 33 CFR 117.35.
Coast Guard, DHS.
Notice of deviation from drawbridge regulation.
The Coast Guard has issued a temporary deviation from the operating schedule that governs the Montlake Bridge across Lake Washington Ship Canal, mile 5.2, at Seattle, WA. The deviation is necessary to accommodate the annual Beat the Bridge run to benefit the Juvenile Diabetes Research Foundation. This deviation allows the bridge span to remain in the closed-to-navigation position.
This deviation is effective from 8 a.m. to 9 a.m. on May 20, 2018.
The docket for this deviation, USCG-2018-0327 is available at
If you have questions on this temporary deviation, call or email Mr. Steven Fischer, Bridge Administrator, Thirteenth Coast Guard District; telephone 206-220-7282, email
The Washington Department of Transportation, the bridge owner, has requested a temporary deviation from the operating schedule for the Montlake Bridge across Lake Washington Ship Canal, at mile 5.2, at Seattle, WA. The deviation is necessary to accommodate the safe crossing of event participants. The Montlake Bridge is a double leaf bascule bridge; in the closed-to-navigation position the bridge provides 30 feet of vertical clearance, and provides 46 feet of vertical clearance at the center 60 feet of the bridge. To facilitate this event, the double bascule span is authorized to remain in the closed-to-navigation position from 8 a.m. to 9 a.m. on May 20, 2018. The Coast Guard coordinated with the local mariners by requesting any objections via the Local Notice to Mariners.
The normal operating schedule for the Montlake Bridge operates in accordance with 33 CFR 117.1051(e). Waterway usage on the Lake Washington Ship Canal ranges from commercial tug and barge to small pleasure craft. Vessels able to pass through the bridge in the closed-to-navigation position may do so at any time. The bridge will be able to open for emergencies. Lake Washington Ship Canal has no immediate alternate route for vessels to pass. The Coast Guard will also inform the users of the waterways through our Local and Broadcast Notices to Mariners of the change in operating schedule for the bridge so that vessels can arrange their transits to minimize any impact caused by the temporary deviation.
In accordance with 33 CFR 117.35(e), the drawbridge must return to its regular operating schedule immediately at the end of the designated time period. This deviation from the operating regulations is authorized under 33 CFR 117.35.
Coast Guard, DHS.
Notice of deviation from drawbridge regulation.
The Coast Guard has issued a temporary deviation from the operating schedule that governs the upper deck of the Steel Bridge across the Willamette River, mile 12.1, in Portland, OR. The deviation is necessary to support multiple events. This deviation allows the lower lift span of the bridge to remain in the closed-to-navigation position.
This deviation is effective from 9:30 a.m. on May 6, 2018 to 11:59 p.m. on June 23, 2018.
The docket for this deviation, USCG-2018-0284, is available at
If you have questions on this temporary deviation, call or email Mr. Steven Fischer, Bridge Administrator, Thirteenth Coast Guard District; telephone 206-220-7282, email
Union Pacific Railroad Company (UPRR) owns and operates the Steel Bridge across the Willamette River, at mile 12.1, in Portland, OR. UPRR requested a temporary deviation from the operating schedule for the Steel Bridge upper lift span. The deviation is necessary to accommodate multiple community events. This deviation authorizes UPRR to operate the Steel Bridge upper lift span as follows:
The Steel Bridge is a double-deck lift bridge, and the lower lift span operates independent of the upper lift span. To facilitate this deviation, the upper deck will remain in the closed-to-navigation position. When the lower deck is in the closed-to-navigation position, the bridge provides 26 feet of vertical clearance above Columbia River Datum 0.0; and in open-to-navigation position, the vertical clearance is 71 feet above Columbia River Datum 0.0. The lower lift deck of the Steel Bridge operates in accordance with 33 CFR 117.5. The upper lift deck of the Steel Bridge operates in accordance with 33 CFR 117.897(c)(3)(ii), and at the end of this deviation period, the upper deck of the Steel Bridge will resume operating in accordance with 33 CFR 117.897(c)(3)(ii).
Waterway usage on this part of the Willamette River includes vessels ranging from commercial tug and barge to small pleasure craft. Vessels able to pass through the subject bridge with the upper deck in the closed-to-navigation position may do so at any time. The lower lift of the Steel Bridge will be able to open for emergencies, and there is no immediate alternate route for vessels to pass. The Coast Guard requested objections be submitted to this deviation in the Local Notice to Mariners. We have not received any objections to this temporary deviation from the operating schedule. The Coast Guard will also inform the users of the waterway through our Local and Broadcast Notices to Mariners of the change in operating schedule for the subject bridge so that vessel operators can arrange their transits to minimize any impact caused by the temporary deviation.
In accordance with 33 CFR 117.35(e), the drawbridge must return to its regular operating schedule immediately at the end of the designated time period. This deviation from the operating regulations is authorized under 33 CFR 117.35.
Coast Guard, DHS.
Final rule.
The Coast Guard is modifying the operating schedule that governs the Venetian Causeway Bridge (West) across the Atlantic Intracoastal Waterway mile 1088.6, and the operating schedule that governs the Venetian Causeway Bridge (East) across Biscayne Bay, Miami Beach, FL. This action will extend the daily twice an hour opening schedule of the Venetian Causeway Bridges (East and West) to include weekends and Federal holidays. This action is intended to reduce vehicular traffic caused by the on-demand weekend and Federal holiday bridge openings.
This rule is effective May 17, 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 LT Ruth Sadowitz, Coast Guard Sector Miami, FL, Waterways Management Division, telephone 305-535-4307, email
On September 5, 2017, we published a notice of proposed rulemaking (NPRM) entitled Drawbridge Operation Regulation; Atlantic Intracoastal Waterway and Biscayne Bay, Miami, FL in the
The Coast Guard is issuing this rule under authority in 33 U.S.C. 499.
The Venetian Causeway Bridge (West), across the Atlantic Intracoastal Waterway, mile 1088.6, is a double leaf bascule bridge and has a vertical clearance of 12 feet at Mean High Water (MHW) in the closed to navigation position and a horizontal clearance of 90 feet between fenders. The Venetian Causeway Bridge (East), across Biscayne Bay, at Miami Beach, FL is a double leaf bascule bridge with a vertical clearance of 5 feet at MHW in the closed to navigation position and a horizontal clearance of 57 feet between fenders. Presently, in accordance with 33 CFR 117.261(nn) and 33 CFR 117.269, the bridges shall open on signal, except that from 7 a.m. to 7 p.m., Monday through Friday, except Federal holidays, the bridges need only open on the hour and half hour.
Miami-Dade County, the bridge owner, and the Cities of Miami and Miami Beach requested the daily twice an hour operating schedule for both bridges be changed to include weekends and Federal holidays. This should provide relief to the increase vehicle traffic congestion on the weekends while meeting the reasonable needs of navigation.
Of the 2 comments received, one was a political statement that had no bearing on the proposed regulation; the second comment was in favor of the operating schedule change. The submitter in favor of the change did suggest that there may be a negative impact to small entities on land economically if the bridge is open for an extended period of time allowing vessels that have been waiting to pass and vice versa for commercial vessels that missed the opening and have to wait until the next scheduled opening. While the Coast Guard does acknowledge that there may be additional vessels waiting for openings due to this change, it should not have a substantial negative impact on land and maritime traffic as it mirrors the current operating schedule Monday through Friday.
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 protesters.
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 continued ability for vessels to transit the bridge during the twice-an-hour opening schedule. Vessels in distress, Public vessels of the United States and tugs with tows must be passed at any time.
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 no 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 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.
(nn) The Venetian Causeway Bridge (West), mile 1088.6, at Miami. The draw shall open on signal, except that from 7 a.m. to 7 p.m. daily, including Federal holidays, the draw need only open on the hour and half hour.
The Venetian Causeway Bridge (East), across Miami Beach Channel. The draw shall open on signal, except that from 7 a.m. to 7 p.m. daily, including Federal holidays, the draw need only open on the hour and half hour.
Coast Guard, DHS.
Temporary final rule.
The Coast Guard is establishing a temporary safety zone for navigable waters of the San Joaquin River due to an unstable, partially submerged barge with hull number PFE-LB444. The temporary safety zone is needed to protect personnel, vessels, and the marine environment from potential hazards created by the barge and associated recovery efforts. Entry of vessels or persons into this zone is prohibited unless specifically authorized by the Captain of the Port San Francisco.
This rule is effective without actual notice from April 17, 2018 until April 30, 2018. For the purposes of enforcement, actual notice will be used from March 30, 2018 until April 17, 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 Lieutenant Junior Grade Emily K. Rowan, U.S. Coast Guard Sector San Francisco; telephone 415-399-7443, 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 of the emergent nature of the situation. Delaying the effective date of this rule would be impracticable because immediate action is needed protect personnel, vessels, and the marine environment from potential hazards associated with the barge and associated recovery efforts.
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; 50 U.S.C. 191; 33 CFR 1.05-1, 6.04-1, 6.04-6, 160.5; Department of Homeland Security Delegation No. 0170.1, which collectively authorize the Coast Guard to establish safety zones. The Captain of the Port San Francisco (COTP) has determined that potential hazards associated with the barge and associated recovery efforts starting March 30, 2018, will be a safety concern for anyone within a 90-yard radius of the barge. This rule is needed to protect personnel, vessels, and the marine environment in the navigable waters within the safety zone.
This rule establishes a temporary safety zone from March 30, 2018 through April 30, 2018. The safety zone will cover all navigable waters within 90 yards of the unstable barge and associated recovery efforts centered in approximate position 37°59′41.88″ N, 121°25′8.88″ W (NAD 83). The effect of the temporary safety zone is intended to protect personnel, vessels, and the marine environment in these navigable waters from potential hazards associated with the barge and associated recovery efforts. No vessel or person will be permitted to enter the safety zone without obtaining permission from the COTP or a designated representative.
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 limited duration and narrowly tailored geographic area of the safety zone. Although this rule restricts access to the waters encompassed by the safety zone, the effect of this rule will not be significant because the local waterway users will be notified via public Broadcast Notice to Mariners to ensure the safety zone will result in minimum impact. The entities most likely to be affected are waterfront facilities, commercial vessels, and pleasure craft engaged in recreational activities.
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 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.
This rule may affect the following entities, some of which may be small entities: Owners and operators of waterfront facilities, commercial vessels, and pleasure craft engaged in recreational activities and sightseeing, if these facilities or vessels are in the vicinity of the safety zone at times when this zone is being enforced. This rule will not have a significant economic impact on a substantial number of small entities for the following reasons: (i) This rule will encompass only a small portion of the waterway for a limited period of time, and (ii) the maritime public will be advised in advance of these safety zones via Broadcast Notice to Mariners.
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 Management Directive 023-01, which guides 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 involves safety zones of limited size and duration. It is categorically excluded from further review under Categorical Exclusion L60(d) of Appendix A, Table 1 of DHS Instruction Manual 023-01-001-01, Rev. 01. A Record of Environmental Consideration supporting this determination will be prepared and submitted after issuance or publication in accordance with DHS Instruction Manual 023-01-001-01, Rev. 01.
The Coast Guard respects the First Amendment rights of protesters.
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)
(d)
(2) The safety zone is closed to all vessel traffic, except as may be permitted by the COTP or a designated representative.
(3) Vessel operators desiring to enter or operate within the safety zone must contact the COTP or a designated representative to obtain permission to do so. Vessel operators given permission to enter or operate in the safety zone must comply with all directions given to them by the COTP or a designated representative. Persons and vessels may request permission to enter the safety zones on VHF-23A or through the 24-hour Command Center at telephone (415) 399-3547.
Coast Guard, DHS.
Final rule.
The Coast Guard is establishing moving safety zones for certain waters within the Sector Key West Captain of the Port (COTP) Zone for five annually recurring marine events. This action is necessary to provide for the safety of the participants, participant vessels, and the general public on the navigable waters of the United States during these events. When these safety zones are activated and subject to enforcement, this rule would prohibit persons and vessels, other than those participating in the event, from entering, transiting through, anchoring in, or remaining within the regulated area unless authorized by the COTP Key West or a designated representative.
This rule is effective May 17, 2018.
To view documents mentioned in this preamble as being available in the docket, go to
If you have questions on this rulemaking, call or email Lieutenant Scott Ledee, Waterways Management Division Chief, Sector Key West, FL, U.S. Coast Guard; telephone (305) 292-8768, email
Swim events and marine events are held on an annual recurring basis on the navigable waters within the Sector Key West COTP Zone. In the past, the Coast Guard has established safety zones for these annual recurring events on a case by case basis to ensure the protection of the maritime public and event participants from the hazards associated with these events. This rule will consistently apprise the public in a timely manner through permanent publication in Title 33 of the Code of Federal Regulations. The Table in this rule lists each annual recurring event requiring a regulated area as administered by the Coast Guard.
By establishing a permanent regulation containing these annual recurring marine events, the Coast Guard would eliminate the need to establish temporary rules for events that occur on an annual basis. On May 16, 2017, the Coast Guard published a notice of proposed rulemaking (NPRM) titled Safety Zone; Recurring Marine Events, Sector Key West, Florida, 82 FR 22448. There we stated why we issued the NPRM, and invited comments on our proposed regulatory action related to these recurring marine events. During the comment period that ended June 15, 2017, we received no comments.
The legal basis and authorities for this rule is found in 33 U.S.C. 1231.
As noted above, we received no comments on our NPRM published May 16, 2017. There are no changes in the regulatory text of this rule from the proposed rule in the NPRM. This rule establishes five new annually recurring marine events to 33 CFR 165.786, as listed in the attached Table to § 165.786. The Table provides the event name, the sponsor name, the location of the event, and the approximate date and time of each event. The specific times, dates, regulated areas and enforcement period
The safety zones established by this rule would cover all waters within 50 yards in front of the lead safety vessel preceding the first event participants, 50 yards behind the safety vessel trailing the last event participants, and at all times extend 100 yards on either side of the safety vessels.
This rule prevents vessels from transiting areas specifically designated as safety zones during the periods of enforcement to ensure the protection of the maritime public and event participants from the hazards associated with the listed annual recurring events. No vessel or person would be permitted to enter the safety zone without obtaining permission from the COTP Key West or a designated representative.
The regulatory text appears at the end of this document.
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: (1) The safety zones would only be enforced during limited time intervals during the swim and paddle events; (2) vessels may be authorized to enter the regulated areas with permission of the COTP Key West or a designated representative; and (3) advanced notification of closures will be made via Local Notice to Mariners, Broadcast to Mariners, and through a Notice of Enforcement published in the
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 received no comments from the Small Business Administration on this rulemaking. 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 zones may be small entities, for the reasons stated in section IV.A above, this rule would 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 would 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 would 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 would 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, which guides 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 involves the establishment of safety zones. 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, 160.5; Department of Homeland Security Delegation No. 0170.1.
(a)
(2) These regulations will be enforced for the duration of each event. Notifications of exacts dates and times of the enforcement period will be made to the local maritime community through the Local Notice to Mariners and Broadcast Notice to Mariners and through a Notice of Enforcement in the
(3) During periods of enforcement, upon being hailed by a Coast Guard vessel by siren, radio, flashing light or other means, the operator must proceed as directed.
(4) Vessel operators desiring to enter, transit through, anchor in, or remain within the regulated area during the enforcement period shall contact the COTP Sector Key West or the designated on-scene representative via VHF channel 16 or call the Sector Key West Command Center at (305) 292-8727 to obtain permission.
(b)
(c) The COTP Key West or designated representative may delay or terminate any event in this subpart at any time to ensure safety of life or property. Such action may be justified as a result of weather, traffic density, spectator operation, or participant behavior.
(d) The regulated area for all marine events listed in Table 1 of § 165.786 is that area of navigable waters within 50 yards in front of the lead safety vessel preceding the first event participants, 50 yards behind the safety vessel trailing the last event participants, and at all times extend 100 yards on either side of safety vessels.
U.S. Army Corps of Engineers, DoD.
Final rule.
The U.S. Army Corps of Engineers (Corps) is establishing a no anchorage restricted area within waters along the Back Bay of Biloxi shoreline of the Keesler Air Force Base (KAFB) located in Biloxi, Mississippi, on behalf of a request by the United States Air Force (USAF) 81st Security Forces Anti-Terrorism Office. The no anchorage restricted area will be established by placing 12 buoys to demarcate the approximately 10,000 feet of shoreline east to west and extend approximately 150 feet from the shoreline of the base. The restricted area is essential to address a major anti-terrorism and safety concern due to the lack of perimeter fencing or physical denial system.
U.S. Army Corps of Engineers, Attn: CECW-CO (David Olson), 441 G Street NW, Washington, DC 20314-1000.
Mr. David Olson, Headquarters, Operations and Regulatory Community of Practice, Washington, DC at 202-761-4922 or Mr. Don Mroczko, U.S. Army Corps of Engineers, Mobile District, at 251-690-3185.
The 81st Security Forces Anti-Terrorism Office, KAFB, located in Biloxi, Mississippi is responsible for United States Air Force perimeter security at KAFB located in Biloxi, Mississippi. In accordance with Department of Defense and Department of the Air Force guidance, the 81st Security Forces Anti-Terrorism Office is responsible for the antiterrorism efforts and force protection of Department of the Air Force assets under his or her charge. In response to a request by the United States Air Force, and pursuant to its authorities in Section 7 of the Rivers and Harbors Act of 1917 (40 Stat. 266; 33 U.S.C. 1) and Chapter XIX of the Army Appropriations Act of 1919 (40 Stat. 892; 33 U.S.C. 3), the Corps is amending the regulations in 33 CFR part 334 by establishing a new restricted area.
The proposed rule was published in the November 16, 2017, edition of the
In response to a request by the United States Air Force, and pursuant to its authorities in Section 7 of the Rivers and Harbors Act of 1917 (40 Stat. 266; 33 U.S.C. 1) and Chapter XIX of the Army Appropriations Act of 1919 (40 Stat. 892; 33 U.S.C. 3), the Corps is amending the regulations in 33 CFR part 334 by establishing a new restricted area.
a.
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 because it is exempt from the requirements of Executive Order 13771.
The Corps has made a determination this rule is not a significant regulatory action. This regulatory action determination is based on the size, duration, and location of the restricted area. The restricted area occupies a small portion of the waterway and a vessel that needs to transit the restricted area may do so if the operator of the vessel obtains permission from the USAF 81st Security Forces Anti-Terrorism Office, KAFB or its authorized representative.
b.
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 Corps certifies under 5 U.S.C. 605(b) that this rule would not have a significant economic impact on a substantial number of small entities. While some owners or operators of vessels that intend to transit the restricted area may be small entities, for the reasons stated in paragraph (a) above this rule would not have a significant economic impact on any vessel owner or operator. In addition, the restricted area is necessary to address a major anti-terrorism and safety concern due to the lack of perimeter fencing or physical denial system. Small entities can utilize navigable waters outside of the restricted area. Small entities may also transit the restricted area as long as they obtain permission from the USAF 81st Security Forces Anti-Terrorism Office, KAFB, Biloxi, Mississippi, or its authorized representative. The restricted area is necessary for security of KAFB. The Corps determined that the restricted area would have practically no economic impact on the public, any anticipated navigational hazard or interference with existing waterway traffic. After considering the economic impacts of this restricted area regulation on small entities, I certify that this action will not have a significant impact on a substantial number of small entities.
c.
d.
Danger zones, Navigation (water), Restricted areas, Waterways.
For the reasons set out in the preamble, the Corps amends 33 CFR part 334 as follows:
40 Stat. 266 (33 U.S.C. 1) and 40 Stat. 892 (33 U.S.C. 3).
(a)
(b)
(2) The restricted area is in effect twenty-four hours per day and seven days a week (24/7).
(3) Should warranted access into the restricted navigation area be needed, all entities are required to contact the USAF 81st Security Forces Anti-Terrorism Office, KAFB, Biloxi, Mississippi, or its authorized representative.
(c)
Legal Services Corporation.
Final rule.
This final rule removes the Legal Services Corporation (LSC) regulation on state advisory councils. LSC believes this action is appropriate because the state advisory councils are no longer active and their oversight functions have been replaced adequately by other offices and processes established since the regulation was promulgated. Executive Orders 13563, “Improving Regulation and Regulatory Review,” and 13771, “Reducing Regulation and Controlling Regulatory Costs,” direct agencies to review their existing regulations and repeal or revise any that are obsolete or unnecessarily burdensome. Although LSC is not an agency of the Federal government subject to either Executive order, LSC regularly reviews its regulations and has determined that this regulation can be eliminated.
This final rule is effective on May 17, 2018.
Stefanie K. Davis, Assistant General Counsel, Legal Services Corporation, 3333 K Street NW, Washington, DC 20007; (202) 295-1563 (phone), (202) 337-6519 (fax), or
Section 1004(f) of the Legal Services Corporation Act of 1974 required that “within six months after the first meeting of the Board, the Board request the Governor of each State to appoint a nine-member advisory council for each state.” 42 U.S.C. 2996c(f). If ninety days elapsed without the Governor's appointing the advisory council, then “the Board [was] authorized to appoint such a council.”
The state advisory councils' primary duty was to notify LSC of any “apparent violation” by a recipient. 45 CFR 1603.5. LSC defined “apparent violation” as “a complaint or other written communication alleging facts which, if established, constitute a violation of the [LSC] Act, or any applicable rules, regulations or guidelines promulgated pursuant to the Act.”
LSC met the requirements of § 1004(f) of the LSC Act by requesting state governors to appoint state advisory councils within the period established by the Act and part 1603. In 1976, 46 state advisory councils were in existence, but later reports reflect that many of these councils rarely, if ever, met. Letter from Suzanne B. Glasow, Senior Counsel for Operations and Regulations, Office of General Counsel, to Mike Sims, Office of Rep. Pete Laney at 1 (Sept. 19, 1989). By 1983, only six state advisory councils appeared to be operational and by 1989, only Colorado and Indiana had functioning state advisory councils.
In 2014, LSC's Office of the Inspector General (OIG) recommended that LSC either ensure that the state advisory councils have been established and are operational or rescind part 1603. LSC is rescinding part 1603 for four reasons: (1) LSC complied with the requirements of section 1004(f) of the LSC Act by requesting state governors to appoint state advisory councils within the period established by the Act and part 1603; (2) section 1004(f) of the LSC Act and part 1603 provide LSC with discretion to exercise or not exercise the option to appoint state councils; (3) to LSC's knowledge, there are no functioning state advisory councils; and (4) there are now numerous oversight mechanisms that fulfill the function of the state advisory councils.
At its January 2015 meeting, the Operations and Regulations Committee (Committee) of LSC's Board of Directors (Board) recommended including the repeal of part 1603 on LSC's regulatory agenda, but made the initiative a low priority.
On January 30, 2017, the President signed Executive Order 13771, “Reducing Regulation and Controlling Regulatory Costs.” Through this Executive order, the President directed the heads of executive departments and agencies to identify at least two prior regulations to be repealed for each new regulation issued. By operation of the LSC Act, LSC is not an executive department or agency subject to the Executive order. 42 U.S.C 2996d(e). Consistent with the intent of the Executive order to reduce unnecessary regulations, however, LSC prioritized the repeal of part 1603.
Prior to initiating rulemaking, LSC conducted an analysis of the oversight mechanisms that have developed since the LSC Act was passed in 1974. LSC determined that the state advisory councils' oversight functions have been replaced adequately by other offices and processes established since 1974. Complainants not only have more audiences—including LSC's OIG, LSC's Office of Compliance and Enforcement (OCE), and state bodies—for their complaints, but they also have more vehicles for filing complaints, including by phone, postal mail, email, online, and through grantee grievance procedures. The OIG and OCE go beyond the state advisory committees' narrow role of collecting alleged violations by also investigating the allegations and using various tools to ensure grantee compliance. Furthermore, state and local funding, state access to justice commissions, and the role of state and local bars in appointing grantee board members all ensure that there is continued local involvement in legal aid funded by LSC. LSC's analysis of these mechanisms is covered in greater detail in the Justification Memorandum for Rulemaking to Rescind 45 CFR part 1603—State Advisory Councils (Justification Memo),
On April 23, 2017, the Committee approved Management's proposed 2017-2018 rulemaking agenda, which included rescinding 45 CFR part 1603 as a priority rulemaking item. On October 15, 2017, the Committee voted to recommend that the Board authorize LSC to begin rulemaking on part 1603. On October 17, 2017, the Board authorized LSC to begin rulemaking. On January 21, 2018, the Committee voted to recommend that the Board authorize publication of a Notice of Proposed Rulemaking (NPRM) proposing to repeal part 1603. On January 23, 2018, the Board authorized publication of the NPRM with a 30-day comment period. On February 1, 2018, LSC published the NPRM in the
On April 8, 2018, the Committee voted to recommend that the Board adopt this final rule and approve its publication in the
During the 30-day public comment period, LSC received one comment from a current law student. The commenter generally supported LSC's proposal to remove part 1603, citing reasons similar to those presented by LSC in the Justification Memo and NPRM. The commenter suggested that the councils could be re-established to ensure continued local involvement. LSC's Justification Memo addressed this
The comment also stated that the “[t]he decision [whether to repeal] should be based on what affect[s] the United States taxpayers.” LSC agrees. LSC does not think it would be a good use of LSC resources, which include taxpayer money, to rejuvenate the state advisory councils when their functions are being performed well by a variety of other mechanisms, as highlighted in the Justification Memo and the NPRM.
LSC is removing part 1603. In a final rule published elsewhere in this issue of the
Materials regarding this rulemaking are available in the open rulemaking section of LSC's website at
Advisory committees; Legal services.
In rule document 2018-06657 beginning on page 15075 in the issue of Monday, April 9, 2018, make the following correction:
On page 15080, in the first column, amendatory instruction 70 should read as follows:
Federal Aviation Administration (FAA), DOT.
Notice of proposed rulemaking (NPRM).
We propose to supersede Airworthiness Directive (AD) 2017-15-17, which applies to certain Airbus Model A300 B4-600R series airplanes, Model A300 C4-605R Variant F airplanes, and Model A300 F4-600R series airplanes. AD 2017-15-17 requires an inspection of the lower area of a certain frame radius for cracking, and corrective action if necessary. Since we issued AD 2017-15-17, we have determined that repetitive inspections and applicable corrective actions are necessary. This proposed AD would add new repetitive inspections of the lower area of a certain frame radius for cracking, and corrective actions if necessary. We are proposing this AD to address the unsafe condition on these products.
We must receive comments on this proposed AD by June 1, 2018.
You may send comments, using the procedures found in 14 CFR 11.43 and 11.45, by any of the following methods:
•
•
•
•
For service information identified in this NPRM, contact Airbus SAS, Airworthiness Office—EAW, 1 Rond Point Maurice Bellonte, 31707 Blagnac Cedex, France; telephone +33 5 61 93 36 96; fax +33 5 61 93 44 51; email
You may examine the AD docket on the internet at
Dan Rodina, Aerospace Engineer, International Section, Transport Standards Branch, FAA, 2200 South 216th St., Des Moines, WA 98198; telephone and fax 206-231-3225.
We invite you to send any written relevant data, views, or arguments about this proposed AD. Send your comments to an address listed under the
We will post all comments we receive, without change, to
We issued AD 2017-15-17, Amendment 39-18977 (82 FR 35644, August 1, 2017) (“AD 2017-15-17”), for certain Airbus Model A300 B4-600R series airplanes, Model A300 C4-605R Variant F airplanes, and Model A300 F4-600R series airplanes. AD 2017-15-17 was prompted by the detection of cracking that originated from the fastener holes in the forward fitting lower radius of frame (FR) 40. AD 2017-15-17 requires an inspection of the lower area of a certain frame radius for cracking, and corrective action if necessary. We issued AD 2017-15-17 to detect and correct cracking in the forward fitting lower radius of FR 40. Such cracking could reduce the structural integrity of the fuselage.
Since we issued AD 2017-15-17, we have determined that new repetitive inspections of the lower area of a certain frame radius for cracking, and corrective actions are necessary.
The European Aviation Safety Agency (EASA), which is the Technical Agent for the Member States of the European Union, has issued EASA AD 2017-0158, dated August 25, 2017 (referred to after this as the Mandatory Continuing Airworthiness Information, or “the MCAI”), to correct an unsafe condition for certain Airbus Model A300 B4-600R series airplanes, Model A300 C4-605R Variant F airplanes, and Model A300 F4-600R series airplanes. The MCAI states:
Following a full stress analysis of the Frame (FR) 40 lower area, supported by a Finite Element Model (FEM), of the post-mod [modification] 10221 configuration, it was demonstrated that, for the FR40 forward fitting lower radius, a crack could occur after a certain number of flight cycles (FC).
This condition, if not detected and corrected, could reduce the structural integrity of the fuselage.
To address this potential unsafe condition, Airbus established that crack detection could be achieved through a special detailed inspection (SDI) using a high frequency eddy current (HFEC) method, and issued Alert Operators Transmission (AOT) A57W009-16 to provide those inspection instructions.
Consequently, EASA issued AD 2016-0085 to require a one-time SDI of the FR40 lower area and, depending on findings, accomplishment of applicable corrective action(s). After that [EASA] AD was issued, further cracks were detected, originating from
The one-time SDI for high cycle A300-600 aeroplanes was intended to mitigate the highest risks within the fleet, pending development of instructions for repetitive inspections.
Since EASA AD 2016-0179 was issued, Airbus published SB A300-57-6120 * * * [for] the inspection programme for A300-600 * * * post-mod 10221 * * * [airplanes]. The AOT one-time inspection is superseded by these repetitive inspection SBs. These SBs include alternative inspection methods and repair solutions in case of findings together with the associated inspection programme.
For the reasons described above, this [EASA] AD retains the requirements of EASA AD 2016-0179, which is superseded, * * * and defines new inspections methods with new compliance times, including repetitive inspections, depending on the aeroplane inspection status.
Airbus has issued Service Bulletin A300-57-6120, including Appendices 1 through 7, dated April 28, 2017. This service information describes procedures for repetitive inspections of the forward fitting lower radius of FR 40 for cracking, and corrective action. This service information is reasonably available because the interested parties have access to it through their normal course of business or by the means identified in the
This product has been approved by the aviation authority of another country, and is approved for operation in the United States. Pursuant to our bilateral agreement with the State of Design Authority, we have been notified of the unsafe condition described in the MCAI and service information referenced above. We are proposing this AD because we evaluated all pertinent information and determined an unsafe condition exists and is likely to exist or develop on other products of the same type design.
We estimate that this proposed AD affects 94 airplanes of U.S. registry.
The actions required by AD 2017-15-17, and retained in this proposed AD, take about 4 work-hours per product, at an average labor rate of $85 per work-hour. Based on these figures, the estimated cost of the actions that are required by AD 2017-15-17 is $340 per product.
We also estimate that it would take about 4 work-hours per product to comply with the basic requirements of this proposed AD. The average labor rate is $85 per work-hour. Based on these figures, we estimate the cost of this proposed AD on U.S. operators to be $31,960, or $340 per product.
We have received no definitive data that would enable us to provide cost estimates for the on-condition actions specified in this proposed AD.
A federal agency may not conduct or sponsor, and a person is not required to respond to, nor shall a person be subject to penalty for failure to comply with a collection of information subject to the requirements of the Paperwork Reduction Act unless that collection of information displays a current valid OMB control number. The control number for the collection of information required by this AD is 2120-0056. The paperwork cost associated with this AD has been detailed in the Costs of Compliance section of this document and includes time for reviewing instructions, as well as completing and reviewing the collection of information. Therefore, all reporting associated with this AD is mandatory. Comments concerning the accuracy of this burden and suggestions for reducing the burden should be directed to the FAA at 800 Independence Ave. SW, Washington, DC 20591, ATTN: Information Collection Clearance Officer, AES-200.
Title 49 of the United States Code specifies the FAA's authority to issue rules on aviation safety. Subtitle I, section 106, describes the authority of the FAA Administrator. “Subtitle VII: Aviation Programs,” describes in more detail the scope of the Agency's authority.
We are issuing this rulemaking under the authority described in “Subtitle VII, Part A, Subpart III, Section 44701: General requirements.” Under that section, Congress charges the FAA with promoting safe flight of civil aircraft in air commerce by prescribing regulations for practices, methods, and procedures the Administrator finds necessary for safety in air commerce. This regulation is within the scope of that authority because it addresses an unsafe condition that is likely to exist or develop on products identified in this rulemaking action.
This AD is issued in accordance with authority delegated by the Executive Director, Aircraft Certification Service, as authorized by FAA Order 8000.51C. In accordance with that order, issuance of ADs is normally a function of the Compliance and Airworthiness Division, but during this transition period, the Executive Director has delegated the authority to issue ADs applicable to transport category airplanes to the Director of the System Oversight Division.
We determined that this proposed AD would not have federalism implications under Executive Order 13132. This proposed AD would not have a substantial direct effect on the States, on the relationship between the national Government and the States, or on the distribution of power and responsibilities among the various levels of government.
For the reasons discussed above, I certify this proposed regulation:
1. Is not a “significant regulatory action” under Executive Order 12866;
2. Is not a “significant rule” under the DOT Regulatory Policies and Procedures (44 FR 11034, February 26, 1979);
3. Will not affect intrastate aviation in Alaska; and
4. Will not have a significant economic impact, positive or negative, on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.
Air transportation, Aircraft, Aviation safety, Incorporation by reference, Safety.
Accordingly, under the authority delegated to me by the Administrator, the FAA proposes to amend 14 CFR part 39 as follows:
49 U.S.C. 106(g), 40113, 44701.
We must receive comments by June 1, 2018.
This AD replaces AD 2017-15-17, Amendment 39-18977 (82 FR 35644, August 1, 2017) (“AD 2017-15-17”).
This AD applies to Airbus airplanes, certificated in any category, identified in paragraphs (c)(1), (c)(2), and (c)(3) of this AD, on which Airbus Modification 10221 was embodied in production.
(1) Airbus Model A300 B4-605R and B4-622R airplanes.
(2) Airbus Model A300 C4-605R Variant F airplanes.
(3) Airbus Model A300 F4-605R and F4-622R airplanes.
Air Transport Association (ATA) of America Code 57, Wings.
This AD was prompted by the detection of cracking that originated from the fastener holes in the forward fitting lower radius of frame (FR) 40. We are issuing this AD to detect and correct cracking in the forward fitting lower radius of FR 40. Such cracking could reduce the structural integrity of the fuselage.
Comply with this AD within the compliance times specified, unless already done.
(1) For the purpose of this AD, the average flight time (AFT) can be established by dividing the flight hours (FHs) by the flight cycles (FCs) counted:
(i) From first flight, for selecting the inspection threshold of the non-repaired area,
(ii) From repair, for selecting the inspection threshold of the repaired area,
(iii) From the last inspection, for selecting the inspection interval.
(2) For the purpose of this AD, Group 1 airplanes are those airplanes already inspected in accordance with paragraph 4.2.2 in Alert Operators Transmission (AOT) A57W009-16, Revision 01, dated July 13, 2016, before the effective date of this AD. Group 2 airplanes are those airplanes not inspected in accordance with paragraph 4.2.2 in AOT A57W009-16, Revision 01, dated July 13, 2016, as of the effective date of this AD.
(3) For the purpose of this AD, inspection method A is a high frequency (HFEC) inspection of the radius and fastener area. Inspection method B is a HFEC inspection of the radius and fastener area and a rototest of the fastener hole. Both are defined as a special detailed inspection (SDI) in this AD.
Within the compliance time specified in table 1 to paragraph (h) of this AD (Group 1 airplanes) or table 2 to paragraph (h) of this AD (Group 2 airplanes), as applicable, and, thereafter, at intervals not exceeding the values specified in table 3 to paragraph (h) of this AD, do a SDI for cracking of any non-repaired radius, fastener areas, and fastener holes, in accordance with the Accomplishment Instructions of Airbus Service Bulletin A300-57-6120, including Appendices 1 through 7, dated April 28, 2017; except where Airbus Service Bulletin A300-57-6120, including Appendices 1 through 7, dated April 28, 2017, specifies contacting Airbus for appropriate action, before further flight, obtain instructions using the procedures specified in paragraph (l) of this AD and accomplish those instructions.
Within the compliance time values as specified in table 4 to paragraph (i) of this AD, and, thereafter, at intervals not exceeding those same values, do a SDI for cracking of the repaired radius, fastener areas, and fastener holes, in accordance with the Accomplishment Instructions of Airbus Service Bulletin A300-57-6120, including Appendices 1 through 7, dated April 28, 2017; except where Airbus Service Bulletin A300-57-6120, including Appendices 1 through 7, dated April 28, 2017, specifies contacting Airbus for appropriate action, before further flight, obtain instructions using the procedures specified in paragraph (l) of this AD and accomplish those instructions.
If any crack is found during any inspection required by paragraph (h) or (i) of this AD: Before further flight, repair in accordance with the Accomplishment Instructions of Airbus Service Bulletin A300-57-6120, including Appendices 1 through 7, dated April 28, 2017.
Submit a report of the findings (both positive and negative) of each inspection required by paragraph (h) and (i) of this AD to Airbus, in accordance with the instructions of Airbus Service Bulletin A300-57-6120, including Appendices 1 through 7, dated April 28, 2017, at the applicable time specified in paragraph (k)(1) or (k)(2) of this AD.
(1) If the inspection was done on or after the effective date of this AD: Submit the report within 30 days after the inspection.
(2) If the inspection was done before the effective date of this AD: Submit the report within 30 days after the effective date of this AD.
(1)
(2)
(3)
(1) Refer to Mandatory Continuing Airworthiness Information (MCAI) EASA Airworthiness Directive 2017-0158, dated August 25, 2017, for related information. This MCAI may be found in the AD docket
(2) For more information about this AD, contact Dan Rodina, Aerospace Engineer, International Section, Transport Standards Branch, FAA, 2200 South 216th St., Des Moines, WA 98198; telephone and fax 206-231-3225.
(3) For service information identified in this AD, contact Airbus SAS, Airworthiness Office—EAW, 1 Rond Point Maurice Bellonte, 31707 Blagnac Cedex, France; telephone +33 5 61 93 36 96; fax +33 5 61 93 44 51; email
Federal Aviation Administration (FAA), DOT.
Notice of proposed rulemaking (NPRM).
We propose to supersede Airworthiness Directive (AD) 2016-13-06, which applies to certain Saab AB, Saab Aeronautics Model 340A (SAAB/SF340A) and SAAB 340B airplanes. AD 2016-13-06 requires a revision of the applicable airplane flight manual (AFM), repetitive inspections of the horizontal stabilizer de-icing boots, and applicable corrective actions. Since we issued AD 2016-13-06, the manufacturer has developed an improved de-icing boot. This proposed AD would continue to require a revision of the applicable AFM, repetitive inspections of the horizontal stabilizer de-icing boots, and applicable corrective actions. This proposed AD would also require replacement of single stitched de-icing boots with improved double stitched boots, and re-identification of the modified horizontal stabilizer leading edge. We are proposing this AD to address the unsafe condition on these products.
We must receive comments on this proposed AD by June 1, 2018.
You may send comments, using the procedures found in 14 CFR 11.43 and 11.45, by any of the following methods:
•
•
•
•
For service information identified in this NPRM, contact Saab AB, Saab Aeronautics, SE-581 88, Linköping, Sweden; telephone: +46 13 18 5591; fax: +46 13 18 4874; email:
You may examine the AD docket on the internet at
Shahram Daneshmandi, Aerospace Engineer, International Section, Transport Standards Branch, FAA, 2200 South 216th St., Des Moines, WA 98198; telephone and fax: 206-231-3220.
We invite you to send any written relevant data, views, or arguments about this proposal. Send your comments to an address listed under the
We will post all comments we receive, without change, to
We issued AD 2016-13-06, Amendment 39-18570 (81 FR 41432, June 27, 2016) (“AD 2016-13-06”), for certain Saab AB, Saab Aeronautics Model 340A (SAAB/SF340A) and SAAB 340B airplanes. AD 2016-13-06 was prompted by reports of ruptured horizontal stabilizer de-icing boots. AD 2016-13-06 requires a revision of the applicable AFM, repetitive inspections of the horizontal stabilizer de-icing boots, and applicable corrective actions. We issued AD 2016-13-06 to detect and correct damage of the de-icing boot; such damage could lead to a ruptured boot, severe vibrations, and possible reduced control of the airplane.
Since we issued AD 2016-13-06, the manufacturer has developed an improved de-icing boot, reinforced through double stitch lines.
The European Aviation Safety Agency (EASA), which is the Technical Agent for the Member States of the European Union, has issued EASA AD 2017-0144, dated August 9, 2017 (referred to after this as the Mandatory Continuing Airworthiness Information, or “the MCAI”), to correct an unsafe condition for certain Saab AB, Saab Aeronautics Model 340A (SAAB/SF340A) and SAAB 340B airplanes. The MCAI states:
Several occurrences were reported of rupture of the horizontal stabilizer de-icing boot in flight. In some of the reported events, the de-icing boot had formed a large open scoop.
This condition, if not detected and corrected, could lead to complete loss of the de-icing function within its associated zone and severe vibrations, possibly resulting in reduced control of the aeroplane.
To address this potential unsafe condition, Saab AB, Aeronautics (hereafter referred to as “Saab” in this [EASA] AD) issued Alert Operations Bulletin (AOB) No. 12 and AOB No. 23 as temporary measures, recommending to select Flaps 0 for landing in the event of a suspected rupture of the de-icing boot on the horizontal stabilizer. In addition, Saab issued SB [Service Bulletin] 340-30-094 providing instructions for inspection of de-icing boots.
Consequently, EASA issued AD 2015-0129 [which corresponds to FAA AD 2016-13-06] to require amendment of the applicable Aircraft Flight Manual (AFM), repetitive inspections of the horizontal stabilizer de-icing boots and, depending on findings, accomplishment of applicable corrective action(s).
Since that [EASA] AD was issued, Saab developed an improved de-icing boot, reinforced through double stitch lines, and issued SB 340-30-095 providing instructions for boot replacement.
For the reason described above, this [EASA] AD retains the requirements of EASA AD 2015-0129, which is superseded, and requires replacement of single stitched de-icing boots, installed on the left-hand (LH) and right-hand (RH) horizontal stabilizer, with improved double stitched boots, and re-identification of the modified horizontal stabilizer leading edge.
You may examine the MCAI in the AD docket on the internet at
Saab AB, Saab Aeronautics has issued the following service information.
• Service Bulletin 340-30-094, dated March 27, 2015. This service information describes procedures for repetitive detailed inspections of the de-icing boots installed on the horizontal stabilizers, and repair and replacement of damaged de-icing boots.
• Service Bulletin 340-30-095, dated April 3, 2017. This service information describes procedures for replacement of single stitched de-icing boots with improved double stitched boots, and re-identification of the modified horizontal stabilizer leading edge.
Saab AB, Saab Aeronautics has also issued the following AFMs, which describe performance limitations and general data. These AFMs are distinct since they apply to different airplane models in different configurations.
• AFM 340A 001, Revision 57, dated March 27, 2015.
• AFM 340B 001, Revision 35, dated March 27, 2015.
• AFM 340B 010, Revision 28, dated March 27, 2015.
This service information is reasonably available because the interested parties have access to it through their normal course of business or by the means identified in the
This product has been approved by the aviation authority of another country, and is approved for operation in the United States. Pursuant to our bilateral agreement with the State of Design Authority, we have been notified of the unsafe condition described in the MCAI and service information referenced above. We are proposing this AD because we evaluated all pertinent information and determined an unsafe condition exists and is likely to exist or develop on other products of these same type designs.
We estimate that this proposed AD affects 51 airplanes of U.S. registry.
The actions required by AD 2016-13-06, and retained in this proposed AD take about 6 work-hours per product, at an average labor rate of $85 per work-hour. Based on these figures, the estimated cost of the actions that are required by AD 2016-13-06 is $510 per product.
In addition, we estimate that any necessary follow-on actions required by AD 2016-13-06, and retained in this proposed AD take about 6 work-hours and require parts costing $9,500, for a cost of $10,010 per product. We have no way of determining the number of aircraft that might need these actions.
We also estimate that it would take about 6 work-hours per product to comply with the basic requirements of this proposed AD. The average labor rate is $85 per work-hour. Required parts would cost about $13,500 per product. Based on these figures, we estimate the cost of this proposed AD on U.S. operators to be $714,510, or $14,010 per product.
Title 49 of the United States Code specifies the FAA's authority to issue rules on aviation safety. Subtitle I, section 106, describes the authority of the FAA Administrator. “Subtitle VII: Aviation Programs,” describes in more detail the scope of the Agency's authority.
We are issuing this rulemaking under the authority described in “Subtitle VII, Part A, Subpart III, Section 44701: General requirements.” Under that section, Congress charges the FAA with promoting safe flight of civil aircraft in air commerce by prescribing regulations for practices, methods, and procedures the Administrator finds necessary for safety in air commerce. This regulation is within the scope of that authority because it addresses an unsafe condition that is likely to exist or develop on products identified in this rulemaking action.
This AD is issued in accordance with authority delegated by the Executive Director, Aircraft Certification Service, as authorized by FAA Order 8000.51C. In accordance with that order, issuance of ADs is normally a function of the Compliance and Airworthiness Division, but during this transition period, the Executive Director has delegated the authority to issue ADs applicable to transport category airplanes to the Director of the System Oversight Division.
We determined that this proposed AD would not have federalism implications under Executive Order 13132. This proposed AD would not have a substantial direct effect on the States, on the relationship between the national Government and the States, or on the distribution of power and responsibilities among the various levels of government.
For the reasons discussed above, I certify this proposed regulation:
1. Is not a “significant regulatory action” under Executive Order 12866;
2. Is not a “significant rule” under the DOT Regulatory Policies and Procedures (44 FR 11034, February 26, 1979);
3. Will not affect intrastate aviation in Alaska; and
4. Will not have a significant economic impact, positive or negative, on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.
Air transportation, Aircraft, Aviation safety, Incorporation by reference, Safety.
Accordingly, under the authority delegated to me by the Administrator, the FAA proposes to amend 14 CFR part 39 as follows:
49 U.S.C. 106(g), 40113, 44701.
We must receive comments by June 1, 2018.
This AD replaces AD 2016-13-06, Amendment 39-18570 (81 FR 41432, June 27, 2016) (“AD 2016-13-06”).
This AD applies to Saab AB, Saab Aeronautics (formerly known as Saab AB, Saab Aerosystems) airplanes, certificated in any category, identified in paragraphs (c)(1) and (c)(2), of this AD.
(1) Saab AB, Saab Aeronautics Model 340A (SAAB/SF340A) airplanes, serial numbers 004 through 138 inclusive, if Saab modification 1462 has been embodied in production, or Saab Service Bulletin 340-55-008 has been embodied in service, except those that have also embodied Saab modification 1793 in production, or Saab Service Bulletin 340-55-010 in service; and serial numbers 139 through 159 inclusive.
(2) Saab AB, Saab Aeronautics Model SAAB 340B airplanes, serial numbers 160 through 459 inclusive.
Air Transport Association (ATA) of America Code 30, Ice and rain protection.
This AD was prompted by reports of ruptured horizontal stabilizer de-icing boots. We are issuing this AD to detect and correct ruptured horizontal stabilizer de-icing boots, which could lead to complete loss of the de-icing function within its associated zone and severe vibrations, possibly resulting in reduced control of the airplane.
Comply with this AD within the compliance times specified, unless already done.
This paragraph restates the requirements of paragraph (g) of AD 2016-13-06, with no changes. Within 30 days after August 1, 2016 (the effective date of AD 2016-13-06), revise the “Abnormal Procedures” section of the applicable Saab 340 AFM to incorporate the revision specified in paragraphs (g)(1) through (g)(3) of this AD.
(1) For Saab AB, Saab Aeronautics Model 340A (SAAB/SF340A) airplanes, revise AFM 340A 001 by incorporating Revision 57, dated March 27, 2015.
(2) For Saab AB, Saab Aeronautics Model SAAB 340B airplanes, revise AFM 340B 001 by incorporating Revision 35, dated March 27, 2015.
(3) For Saab AB, Saab Aeronautics Model SAAB 340B airplanes with extended wing tips, revise AFM 340B 010 by incorporating Revision 28, dated March 27, 2015.
This paragraph restates the requirements of paragraph (h) of AD 2016-13-06, with no changes. Within 400 flight hours or 6 months, whichever occurs first after August 1, 2016 (the effective date of AD 2016-13-06), do a detailed inspection for damage of the horizontal stabilizer de-icing boots, and existing repairs of horizontal stabilizer de-icing boots, in accordance with the Accomplishment Instructions of Saab Service Bulletin 340-30-094, dated March 27, 2015. Repeat the inspection thereafter at intervals not to exceed 400 flight hours. If, during any inspection required by this paragraph, any damage or existing repair outside the limits specified in Saab Service Bulletin 340-30-094, dated March 27, 2015, is found, before further flight, repair or replace the horizontal stabilizer de-icing boots, in accordance with the Accomplishment Instructions of Saab Service Bulletin 340-30-094, dated March 27, 2015. Repair or replacement on an airplane of the horizontal stabilizer de-icing boots, as required by this paragraph, does not constitute terminating action for the repetitive inspections required by this paragraph for that airplane.
Within 18 months after the effective date of this AD, modify the airplane by replacing the single stitched de-icing boots installed on the left-hand (LH) and right-hand (RH) horizontal stabilizers with double stitched de-icing boots and re-identify the LH and RH horizontal stabilizer leading edge, in accordance with the Accomplishment Instructions of Saab Service Bulletin 340-30-095, dated April 3, 2017.
Modification of the airplane as required by paragraph (i) of this AD, constitutes terminating action for the repetitive inspections required by paragraph (h) of this AD, for that airplane.
(1)
(2)
(1) Refer to Mandatory Continuing Airworthiness Information (MCAI) EASA AD 2017-0144, dated August 9, 2017, for related information. This MCAI may be found in the AD docket on the internet at
(2) For more information about this AD, contact Shahram Daneshmandi, Aerospace Engineer, International Section, Transport Standards Branch, FAA, 2200 South 216th St., Des Moines, WA 98198; telephone and fax: 206-231-3220.
(3) For service information identified in this AD, contact Saab AB, Saab Aeronautics, SE-581 88, Linköping, Sweden; telephone: +46 13 18 5591; fax: +46 13 18 4874; email:
Federal Aviation Administration (FAA), DOT.
Notice of proposed rulemaking (NPRM).
We propose to adopt a new airworthiness directive (AD) for all General Electric Company (GE) CF34-8E turbofan engines. This proposed AD was prompted by a report from GE regarding a quality escape of nonconforming thrust reverser fire seals. This proposed AD would require a one-time inspection of the gap between the core cowl seal and the pylon seal of the thrust reverser for correct gap width, and replacement of the seals, if needed. We are proposing this AD to address the unsafe condition on these products.
We must receive comments on this proposed AD by June 1, 2018.
You may send comments, using the procedures found in 14 CFR 11.43 and 11.45, by any of the following methods:
•
•
•
•
For service information identified in this NPRM, contact General Electric Company, 1 Neumann Way, Cincinnati, OH 45215; telephone 513-552-3272; email
You may examine the AD docket on the internet at
David Bethka, Aerospace Engineer, ECO Branch, FAA, 1200 District Avenue, Burlington, MA 01803; phone: 781-238-7129; fax: 781-238-7199; email:
We invite you to send any written relevant data, views, or arguments about this proposal. Send your comments to an address listed under the
We will post all comments we receive, without change, to
We received a report from the manufacturer about a fire seal gap quality escape on GE CF34-8E turbofan engines. Some thrust reverser fire seals, installed on thrust reverser part numbers (P/Ns) 15G0002-013, 15G0002-014, 15G0003-013, and 15G0003-014, were shipped from a supplier with nonconforming seal gaps.
An analysis by the manufacturer has shown that a gap between the 12 o'clock core cowl seal and pylon seal that is greater than the 1 mm design requirement could result in fire outside the fire zone. This unsafe condition, if not addressed, could result in an uncontrolled fire, damage to the engine, and damage to the airplane.
We reviewed GE CF34-8E Service Bulletin (SB) 78-0066 R00, dated December 11, 2017. The SB describes procedures for measuring the width of the RTV filled gap between the thrust reverser fire seals at the 12 o'clock core cowl seal and pylon seal installed on thrust reverser P/Ns 15G0002-013, 15G0002-014, 15G0003-013, and 15G0003-014, and replacing with parts eligible for installation, if needed.
We are proposing this AD because we evaluated all the relevant information and determined the unsafe condition described previously is likely to exist or develop in other products of the same type design.
This proposed AD would require a one-time inspection of the gap between the core cowl seal and the pylon seal of the thrust reverser for correct gap width, and replacement of the thrust reverser fire seals, if needed.
We estimate that this proposed AD affects 936 engines installed on airplanes of U.S. registry.
We estimate the following costs to comply with this proposed AD:
We estimate the following costs to do any necessary replacements that would be required based on the results of the proposed inspection. We have no way of determining the number of aircraft that might need these replacements:
Title 49 of the United States Code specifies the FAA's authority to issue rules on aviation safety. Subtitle I, section 106, describes the authority of the FAA Administrator. Subtitle VII: Aviation Programs, describes in more detail the scope of the Agency's authority.
We are issuing this rulemaking under the authority described in Subtitle VII, Part A, Subpart III, Section 44701: “General requirements.” Under that section, Congress charges the FAA with promoting safe flight of civil aircraft in air commerce by prescribing regulations for practices, methods, and procedures the Administrator finds necessary for safety in air commerce. This regulation is within the scope of that authority because it addresses an unsafe condition that is likely to exist or develop on
This AD is issued in accordance with authority delegated by the Executive Director, Aircraft Certification Service, as authorized by FAA Order 8000.51C. In accordance with that order, issuance of ADs is normally a function of the Compliance and Airworthiness Division, but during this transition period, the Executive Director has delegated the authority to issue ADs applicable to engines, propellers, and associated appliances to the Manager, Engine and Propeller Standards Branch, Policy and Innovation Division.
We determined that this proposed AD would not have federalism implications under Executive Order 13132. This proposed AD would not have a substantial direct effect on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government.
For the reasons discussed above, I certify this proposed regulation:
(1) Is not a “significant regulatory action” under Executive Order 12866,
(2) Is not a “significant rule” under the DOT Regulatory Policies and Procedures (44 FR 11034, February 26, 1979),
(3) Will not affect intrastate aviation in Alaska, and
(4) Will not have a significant economic impact, positive or negative, on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.
Air transportation, Aircraft, Aviation safety, Incorporation by reference, Safety.
Accordingly, under the authority delegated to me by the Administrator, the FAA proposes to amend 14 CFR part 39 as follows:
49 U.S.C. 106(g), 40113, 44701.
We must receive comments by June 1, 2018.
None.
This AD applies to all General Electric Company (GE) CF34-8E turbofan engines.
Joint Aircraft System Component (JASC) Code 7830, Thrust Reverser.
This AD was prompted by a report from GE regarding a quality escape of nonconforming thrust reverser fire seal gaps. We are issuing this AD to inspect for nonconforming thrust reverser fire seal gaps that could result in a fire outside the fire zone. The unsafe condition, if not addressed, could result in an uncontrolled fire, damage to the engine, and damage to the airplane.
Comply with this AD within the compliance times specified, unless already done.
(1) For all CF34-8E turbofan engines, before the engine accumulates 8,000 flight hours after the effective date of this AD, perform the following one-time inspection, and, if needed, replace the core cowl seal and pylon seal.
(i) Measure the width of the RTV filled gap between thrust reverser fire seals at the junction between 12 o'clock core cowl seal and pylon seal, at the following half thrust reverser locations: engine 1 left hand (LH) half thrust reverser, part number (P/N) 15G0002-013; engine 2 LH half thrust reverser, P/N 15G0002-014; engine 1 right hand (RH) half thrust reverser, P/N 15G0003-013; and engine 2 RH half thrust reverser P/N 15G0003-014.
(ii) If the gap width between the 12 o'clock core cowl seal and the pylon seal is greater than 1 mm, replace both seals with parts eligible for installation to form a new gap of 1 mm or less, prior to return to service.
(2) You may refer to GE CF34-8E Service Bulletin 78-0066 R00, dated December 11, 2017 for guidance on inspecting and replacing the thrust reverser fire seals.
(1) The Manager, ECO Branch, FAA, has the authority to approve AMOCs for this AD, if requested using the procedures found in 14 CFR 39.19. In accordance with 14 CFR 39.19, send your request to your principal inspector or local Flight Standards District Office, as appropriate. If sending information directly to the manager of the certification office, send it to the attention of the person identified in paragraph (i)(1) of this AD.
(2) Before using any approved AMOC, notify your appropriate principal inspector, or lacking a principal inspector, the manager of the local Flight Standards District Office/Certificate Holding District Office.
(1) For more information about this AD, contact David Bethka, Aerospace Engineer, ECO Branch, FAA,1200 District Avenue, Burlington, MA 01803; phone: 781-238-7129; fax: 781-238-7199; email:
(2) For service information identified in this AD, contact General Electric Company, 1 Neumann Way, Cincinnati, OH 45215; telephone 513-552-3272; email
Federal Aviation Administration (FAA), DOT.
Notice of proposed rulemaking (NPRM).
We propose to adopt a new airworthiness directive (AD) for certain The Boeing Company Model 747-100, -100B, -100B SUD, -200B, -200C, -200F, -300, -400, -400D, 747SP, and 747SR, and 747-8 series airplanes. This proposed AD was prompted by reports indicating that additional areas of Boeing Material Specification (BMS) 8-39 flexible urethane foam were found during an inspection required by a related AD. This proposed AD would require inspecting for BMS 8-39 flexible urethane foam insulation in the floor panel assemblies and the power drive unit (PDU) cover assemblies; doing applicable on-condition actions; modifying certain dripshields; and replacing BMS 8-39 foam strips on certain dripshields with BMS 8-371 foam strips. We are proposing this AD to address the unsafe condition on these products.
We must receive comments on this proposed AD by June 1, 2018.
You may send comments, using the procedures found in 14 CFR 11.43 and 11.45, by any of the following methods:
•
•
•
•
For service information identified in this NPRM, contact Boeing Commercial Airplanes, Attention: Contractual & Data Services (C&DS), 2600 Westminster Blvd., MC 110-SK57, Seal Beach, CA 90740-5600; telephone 562-797-1717; internet
You may examine the AD docket on the internet at
Scott Craig, Aerospace Engineer, Cabin Safety and Environmental Systems Section, FAA, Seattle ACO Branch, 2200 South 216th St., Des Moines, WA 98198; phone and fax: 206-231-3566; email:
We invite you to send any written relevant data, views, or arguments about this proposal. Send your comments to an address listed under the
We will post all comments we receive, without change, to
We have received reports indicating that additional areas of BMS 8-39 flexible urethane foam were found during the accomplishment of AD 2013-11-04, Amendment 39-17464 (78 FR 33193, June 4, 2013) (“AD 2013-11-04”). AD 2013-11-04 was prompted by in-service reports of burned BMS 8-39 flexible urethane foam, and a report from the airplane manufacturer indicating that airplanes were assembled, throughout various areas of the airplane (including flight deck and cargo compartments), with seals made of BMS 8-39 flexible urethane foam, a material with fire-retardant properties that deteriorate with age. AD 2013-11-04 requires replacing certain seals made of BMS 8-39 flexible urethane foam.
BMS 8-39 flexible urethane foam fire retardants are mixed into, but are not chemically connected with, the remaining components of the foam. Over time, this condition will cause the fire-retardant properties to have decreased effectiveness. The concern is hidden areas where fire cannot easily be detected and suppressed. Aged BMS 8-39 flexible urethane foam exposed to an ignition source provides an unacceptable fuel source for fire propagation. The degradation of the foam increases the potential for an uncontrolled fire below the passenger compartment floor and other locations outside the areas covered by smoke detection and fire protection systems. This condition, if not corrected, could cause an uncontrolled fire leading to loss of control of the airplane.
We reviewed the following Boeing service information.
• Boeing Special Attention Service Bulletin 747-53-2877, dated August 5, 2014, which describes procedures for performing a general visual inspection for BMS 8-39 flexible urethane foam insulation in the floor panel assemblies and the PDU cover assemblies, and applicable on-condition actions.
• Boeing Special Attention Service Bulletin 747-25-3646, Revision 1, dated August 2, 2017, which describes procedures for replacing BMS 8-39 foam strips with BMS 8-371 foam strips on certain dripshields.
• Boeing Special Attention Service Bulletin 747-25-3692, dated June 22, 2016, which describes procedures for modifying and replacing BMS 8-39 foam strips with BMS 8-371 foam strips on certain dripshields.
This service information is reasonably available because the interested parties have access to it through their normal course of business or by the means identified in the
We are proposing this AD because we evaluated all the relevant information and determined the unsafe condition described previously is likely to exist or develop in other products of the same type design.
This proposed AD would require accomplishment of the actions identified as “RC” (required for compliance) in the Accomplishment Instructions of the service information described previously, except as discussed under “Differences Between this Proposed AD and the Service Information,” and except for any differences identified as exceptions in the regulatory text of this proposed AD.
For information on the procedures and compliance times, see this service information at
Although Boeing Special Attention Service Bulletin 747-25-3646, Revision 1, dated August 2, 2017, and Boeing Special Attention Service Bulletin 747-25-3692, dated June 22, 2016, specify a compliance time of 60 months, this AD specifies a compliance time of 72 months for the actions specified in this service information. The 72-month compliance time is in-line with other ADs addressing the same unsafe condition due to the use of BMS 8-39 flexible urethane foam. We have reviewed the safety impact of the 72-month compliance time and found it acceptable. This compliance time has been coordinated with Boeing.
We estimate that this proposed AD affects 87 airplanes of U.S. registry. We
We have received no definitive data that would enable us to provide cost estimates for the on-condition actions specified in this proposed AD.
According to the manufacturer, some of the costs of this proposed AD may be covered under warranty, thereby reducing the cost impact on affected individuals. We do not control warranty coverage for affected individuals. As a result, we have included all available costs in our cost estimate.
Title 49 of the United States Code specifies the FAA's authority to issue rules on aviation safety. Subtitle I, section 106, describes the authority of the FAA Administrator. Subtitle VII: Aviation Programs, describes in more detail the scope of the Agency's authority.
We are issuing this rulemaking under the authority described in Subtitle VII, Part A, Subpart III, Section 44701: “General requirements.” Under that section, Congress charges the FAA with promoting safe flight of civil aircraft in air commerce by prescribing regulations for practices, methods, and procedures the Administrator finds necessary for safety in air commerce. This regulation is within the scope of that authority because it addresses an unsafe condition that is likely to exist or develop on products identified in this rulemaking action.
This proposed AD is issued in accordance with authority delegated by the Executive Director, Aircraft Certification Service, as authorized by FAA Order 8000.51C. In accordance with that order, issuance of ADs is normally a function of the Compliance and Airworthiness Division, but during this transition period, the Executive Director has delegated the authority to issue ADs applicable to transport category airplanes to the Director of the System Oversight Division.
We determined that this proposed AD would not have federalism implications under Executive Order 13132. This proposed AD would not have a substantial direct effect on the States, on the relationship between the national Government and the States, or on the distribution of power and responsibilities among the various levels of government.
For the reasons discussed above, I certify this proposed regulation:
(1) Is not a “significant regulatory action” under Executive Order 12866,
(2) Is not a “significant rule” under the DOT Regulatory Policies and Procedures (44 FR 11034, February 26, 1979),
(3) Will not affect intrastate aviation in Alaska, and
(4) Will not have a significant economic impact, positive or negative, on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.
Air transportation, Aircraft, Aviation safety, Incorporation by reference, Safety.
Accordingly, under the authority delegated to me by the Administrator, the FAA proposes to amend 14 CFR part 39 as follows:
49 U.S.C. 106(g), 40113, 44701.
We must receive comments by June 1, 2018.
None.
This AD applies to The Boeing Company airplanes, certificated in any category, as identified in paragraphs (c)(1), (c)(2), and (c)(3) of this AD.
(1) Model 747-100, -100B, -100B SUD, -200B, -200C, -200F, -300, -400, -400D, 747SP, and 747SR series airplanes, as identified in Boeing Special Attention Service Bulletin 747-53-2877, dated August 5, 2014.
(2) Model 747-400, -400D, and 747-8 series airplanes, as identified in Boeing Special Attention Service Bulletin 747-25-3646, Revision 1, dated August 2, 2017.
(3) Model 747-100, -100B, -100B SUD, -200B, -300, 747SP, and 747SR series airplanes, as identified in Boeing Special Attention Service Bulletin 747-25-3692, dated June 22, 2016.
Air Transport Association (ATA) of America Code 25, Equipment/furnishings; 53, Fuselage.
This AD was prompted by reports indicating that additional areas of Boeing Material Specification (BMS) 8-39 flexible urethane foam were found during an inspection required by a related AD. The degradation of the foam increases the potential for an uncontrolled fire below the passenger compartment floor and other locations outside the areas covered by smoke detection and fire protection systems. We are issuing this AD to detect and replace BMS 8-39 flexible urethane foam in certain areas, which, if exposed to an ignition source, could cause an uncontrolled fire leading to loss of control of the airplane.
Comply with this AD within the compliance times specified, unless already done.
Within 72 months after the effective date of this AD, do all actions identified as “RC” (required for compliance) in, and in
(1) For airplanes identified in paragraph (c)(1) of this AD: Boeing Special Attention Service Bulletin 747-53-2877, dated August 5, 2014.
(2) For airplanes identified in paragraph (c)(2) of this AD: Boeing Special Attention Service Bulletin 747-25-3646, Revision 1, dated August 2, 2017.
(3) For airplanes identified in paragraph (c)(3) of this AD: Boeing Special Attention Service Bulletin 747-25-3692, dated June 22, 2016.
This paragraph provides credit for the actions specified in paragraph (g)(2) of this AD, if those actions were performed before the effective date of this AD using Boeing Special Attention Service Bulletin 747-25-3646, dated June 19, 2015.
(1) The Manager, Seattle ACO Branch, FAA, has the authority to approve AMOCs for this AD, if requested using the procedures found in 14 CFR 39.19. In accordance with 14 CFR 39.19, send your request to your principal inspector or local Flight Standards District Office, as appropriate. If sending information directly to the manager of the certification office, send it to the attention of the person identified in paragraph (j)(1) of this AD. Information may be emailed to:
(2) Before using any approved AMOC, notify your appropriate principal inspector, or lacking a principal inspector, the manager of the local flight standards district office/certificate holding district office.
(3) An AMOC that provides an acceptable level of safety may be used for any repair, modification, or alteration required by this AD if it is approved by the Boeing Commercial Airplanes Organization Designation Authorization (ODA) that has been authorized by the Manager, Seattle ACO Branch, to make those findings. To be approved, the repair method, modification deviation, or alteration deviation must meet the certification basis of the airplane, and the approval must specifically refer to this AD.
(4) For service information that contains steps that are labeled as Required for Compliance (RC), the provisions of paragraphs (i)(4)(i) and (i)(4)(ii) of this AD apply.
(i) The steps labeled as RC, including substeps under an RC step and any figures identified in an RC step, must be done to comply with the AD. If a step or substep is labeled “RC Exempt,” then the RC requirement is removed from that step or substep. An AMOC is required for any deviations to RC steps, including substeps and identified figures.
(ii) Steps not labeled as RC may be deviated from using accepted methods in accordance with the operator's maintenance or inspection program without obtaining approval of an AMOC, provided the RC steps, including substeps and identified figures, can still be done as specified, and the airplane can be put back in an airworthy condition.
(1) For more information about this AD, contact Scott Craig, Aerospace Engineer, Cabin Safety and Environmental Systems Section, FAA, 2200 South 216th St., Des Moines, WA 98198; phone and fax: 206-231-3566; email:
(2) For service information identified in this AD, contact Boeing Commercial Airplanes, Attention: Contractual & Data Services (C&DS), 2600 Westminster Blvd., MC 110-SK57, Seal Beach, CA 90740-5600; telephone 562-797-1717; internet
Federal Aviation Administration (FAA), DOT.
Notice of proposed rulemaking (NPRM).
We propose to adopt a new airworthiness directive (AD) for certain Airbus Model A319 series airplanes; Model A320-211, -212, -214, -231, -232, and -233 airplanes; and Model A321-111, -112, -131, -211, -212, -213, -231, and -232 airplanes. This proposed AD was prompted by investigations that revealed that the cover seal of the brake dual distribution valve (BDDV) was damaged and did not ensure efficient sealing. This proposed AD would require identifying the BDDV part number installed on the airplane, and modifying or replacing BDDVs having certain part numbers. We are proposing this AD to address the unsafe condition on these products.
We must receive comments on this proposed AD by June 1, 2018.
You may send comments, using the procedures found in 14 CFR 11.43 and 11.45, by any of the following methods:
•
•
•
•
For service information identified in this NPRM, contact Airbus, Airworthiness Office—EIAS, 1 Rond Point Maurice Bellonte, 31707 Blagnac Cedex, France; telephone +33 5 61 93 36 96; fax +33 5 61 93 44 51; email
You may examine the AD docket on the internet at
Sanjay Ralhan, Aerospace Engineer, International Section, Transport Standards Branch, FAA, 2200 South 216th St., Des Moines, WA 98198; telephone and fax 206-231-3223.
We invite you to send any written relevant data, views, or arguments about this proposed AD. Send your comments to an address listed under the
We will post all comments we receive, without change, to
The European Aviation Safety Agency (EASA), which is the Technical Agent for the Member States of the European Union, has issued EASA Airworthiness Directive 2017-0119, dated July 11, 2017 (referred to after this as the Mandatory Continuing Airworthiness Information, or “the MCAI”), to correct an unsafe condition for certain Airbus Model A319 series airplanes; Model A320-211, -212, -214, -231, -232, and -233 airplanes; and Model A321-111, -112, -131, -211, -212, -213, -231, and -232 airplanes. The MCAI states:
In 1998, an operator experienced a dual loss of braking systems. Investigation results revealed that the cover seal of the BDDV was damaged and did not ensure the sealing efficiency.
This condition, if not corrected, could lead to water ingestion in the BDDV, freezing of the BDDV in flight, and consequent loss of braking system function after landing, possibly resulting in damage to the aeroplane and injury to occupants.
To address this potential unsafe condition, Airbus issued Alert Operator Telex (AOT) 32-19 and Service Bulletin (SB) A320-32-1199, providing instructions for repetitive functional tests. In addition, Airbus developed mod 28301 and published SB A320-32-1203 to provide modification instructions.
Consequently, DGAC France issued AD 2000-258-146 [which corresponds to FAA AD 2001-15-10, Amendment 39-12344 (66 FR 39413, dated July 31, 2001) (“AD 2001-15-10”)] to require repetitive functional tests as a temporary solution (valid for a period of 15 months) and modification of the BDDV with a new cover and installation of a draining tube with a cap, which was terminating action for the repetitive functional tests. For pre-mod 27833 and pre-SB A320-32-1200 aeroplanes, repetitive inspections per SB A320-32-1199 were required as interim action, prior to the terminating action modification per SB A320-32-1203.
After that [DGAC] AD was issued, following a new event, Airbus developed a new modification of the BDDV drain tube which leaves it open, ensuring continuous drainage of any ingested water, thereby preventing freezing of the brake system.
Consequently, EASA issued AD 2014-0251 (later revised), partially retaining the requirements of DGAC France AD 2000-258-146, which was superseded, and requiring an additional modification of the BDDV drain tube and re-identification of the BDDV.
Since EASA AD 2014-0251R1 [which corresponds to FAA AD 2016-06-13, Amendment 39-18444 (81 FR 17365, dated March 29, 2016) (“AD 2016-06-13”)] was issued, comments were received that indicated a need for correction and clarification. Consequently, this [EASA] AD retains the requirements of EASA AD 2014-0251R1, which is superseded, and expands the list of BDDV Part Numbers (P/N) which must be removed from service and are no longer eligible for installation on an aeroplane [and includes replacing affected part numbers as an option]. This [EASA] AD also clarifies the intended requirements of EASA AD 2014-0251 and introduces editorial changes, not affecting the requirements.
Paragraph (1) of the MCAI is addressed in paragraphs (e) and (f) of FAA AD 2001-15-10; Paragraph (2) of the MCAI is addressed in paragraph (g) of FAA AD 2016-06-13.
This NPRM would not supersede AD 2001-15-10 and AD 2016-06-13. Rather, we have determined that a stand-alone AD would be more appropriate to address the changes in the MCAI. This NPRM would require identifying the BDDV part number installed on the airplane, and modifying or replacing BDDVs having certain part numbers.
Doing the proposed actions would terminate the requirements in paragraphs (e) and (f) of AD 2001-15-10, and would terminate all of the requirements of AD 2016-06-13.
You may examine the MCAI in the AD docket on the internet at
Airbus has issued Service Bulletin A320-32-1203, Revision 02, dated February 9, 2001. This service information describes procedures for identifying the BDDV part number installed on the airplane, and modifying or replacing BDDVs having certain part numbers.
Airbus has also issued Service Bulletin A320-32-1415, Revision 02, dated December 10, 2015. This service information describes procedures for modifying and re-identifying the BDDV. The modification includes modifying the drain hose of the BDDV, and doing all related investigative and corrective actions if applicable. The related investigative actions include an inspection for corrosion. Corrective actions include replacing the BDDV.
This service information is reasonably available because the interested parties have access to it through their normal course of business or by the means identified in the
This product has been approved by the aviation authority of another country, and is approved for operation in the United States. Pursuant to our bilateral agreement with the State of Design Authority, we have been notified of the unsafe condition described in the MCAI and service information referenced above. We are proposing this AD because we evaluated all pertinent information and determined an unsafe condition exists and is likely to exist or develop on other products of these same type designs.
We estimate that this proposed AD affects 1,136 airplanes of U.S. registry.
We estimate the following costs to comply with this proposed AD:
We have received no definitive data that would enable us to provide cost estimates for the on-condition actions specified in this proposed AD.
Title 49 of the United States Code specifies the FAA's authority to issue rules on aviation safety. Subtitle I, section 106, describes the authority of the FAA Administrator. “Subtitle VII: Aviation Programs,” describes in more detail the scope of the Agency's authority.
We are issuing this rulemaking under the authority described in “Subtitle VII, Part A, Subpart III, Section 44701: General requirements.” Under that
This proposed AD is issued in accordance with authority delegated by the Executive Director, Aircraft Certification Service, as authorized by FAA Order 8000.51C. In accordance with that order, issuance of ADs is normally a function of the Compliance and Airworthiness Division, but during this transition period, the Executive Director has delegated the authority to issue ADs applicable to transport category airplanes to the Director of the System Oversight Division.
We determined that this proposed AD would not have federalism implications under Executive Order 13132. This proposed AD would not have a substantial direct effect on the States, on the relationship between the national Government and the States, or on the distribution of power and responsibilities among the various levels of government.
For the reasons discussed above, I certify this proposed regulation:
1. Is not a “significant regulatory action” under Executive Order 12866;
2. Is not a “significant rule” under the DOT Regulatory Policies and Procedures (44 FR 11034, February 26, 1979);
3. Will not affect intrastate aviation in Alaska; and
4. Will not have a significant economic impact, positive or negative, on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.
Air transportation, Aircraft, Aviation safety, Incorporation by reference, Safety.
Accordingly, under the authority delegated to me by the Administrator, the FAA proposes to amend 14 CFR part 39 as follows:
49 U.S.C. 106(g), 40113, 44701.
We must receive comments by June 1, 2018.
This AD affects AD 2001-15-10, Amendment 39-12344 (66 FR 39413, dated July 31, 2001) (“AD 2001-15-10”), and AD 2016-06-13, Amendment 39-18444 (81 FR 17365, dated March 29, 2016) (“AD 2016-06-13”).
This AD applies to the airplanes identified in paragraphs (c)(1) through (c)(3) of this AD, certificated in any category, all manufacturer serial numbers, except those on which Airbus Modification 26925 has been embodied in production, which introduces a modified alternate braking system that removes the brake dual distribution valve (BDDV).
(1) Airbus Model A319-111, -112, -113, -114, -115, -131, -132, and -133 airplanes.
(2) Airbus Model A320-211, -212, -214, -231, -232, and -233 airplanes.
(3) Airbus Model A321-111, -112, -131, -211, -212, -213, -231, and -232 airplanes.
Air Transport Association (ATA) of America Code 32, Landing gear.
This AD was prompted by investigations that revealed that the cover seal of the brake dual distribution valve (BDDV) was damaged and did not ensure efficient sealing. We are issuing this AD to prevent water ingestion in the BDDV, freezing of the BDDV in flight, and consequent loss of braking system function after landing. These conditions could possibly result in damage to the airplane and injury to occupants.
Comply with this AD within the compliance times specified, unless already done.
Within 3 months after the effective date of this AD, identify the BDDV part number installed on the airplane. For each affected BDDV part number specified in figure 1 to paragraphs (g) and (h) of this AD, within 3 months after the effective date of this AD, do the actions in paragraph (g)(1), (g)(2), or (g)(3) of this AD. A review of airplane maintenance records is acceptable to identify the BDDV part number if the part number of the BDDV can be conclusively determined from that review.
(1) Modify and re-identify the affected BDDV, in accordance with the Accomplishment Instructions of Airbus Service Bulletin A320-32-1203, Revision 02, dated February 9, 2001.
(2) Modify and re-identify the affected BDDV, and do all applicable related investigative and corrective, in accordance with the Accomplishment Instructions of Airbus Service Bulletin A320-32-1415, Revision 02, dated December 10, 2015. Do all applicable related investigative and corrective actions before further flight.
(3) Replace the affected BDDV with a BDDV having a part number not specified in figure 1 to paragraphs (g) and (h) of this AD, or a part number specified as `new P/N' in figure 2 to paragraphs (g)(3) and (h)(2) of this AD. Do the replacement using a method approved by the Manager, International Section, Transport Standards Branch, FAA; or the European Aviation Safety Agency (EASA); or Airbus's EASA Design Organization Approval (DOA). If approved by the DOA, the approval must include the DOA-authorized signature.
As of the applicable time specified in paragraph (h)(1) or (h)(2) of this AD, no person may install a BDDV having a part number specified in figure 1 to paragraphs (g) and (h) of this AD, on any airplane.
(1) For any airplane that, on the effective date of this AD, has a BDDV installed with a part number specified in figure 1 to paragraphs (g) and (h) of this AD: After modification of the airplane, as required by paragraph (g) of this AD.
(2) For any airplane that, on the effective date of this AD, has a BDDV installed with a part number specified as `new P/N' in figure 2 to paragraphs (g)(3) and (h)(2) of this AD, or has a BDDV installed with a part number not specified in figure 1 to paragraphs (g) and (h) of this AD: As of the effective date of this AD.
(1) Doing the actions in paragraph (g) of this AD terminates the requirements in paragraphs (e) and (f) of AD 2001-15-10.
(2) Doing the actions in paragraph (g) of this AD terminates all of the requirements of AD 2016-06-13.
(1) This paragraph provides credit for actions required by paragraph (g)(1) of this AD, if those actions were performed before the effective date of this AD using the service information in paragraphs (j)(1)(i) and (j)(1)(ii) of this AD.
(i) Airbus Service Bulletin A320-32-1203, dated June 4, 1999, which was incorporated by reference in AD 2001-15-10.
(ii) Airbus Service Bulletin A320-32-1203, Revision 01, dated October 12, 2000.
(2) This paragraph provides credit for actions required by paragraph (g)(2) of this AD, if those actions were performed before the effective date of this AD using the service information in paragraphs (j)(2)(i) and (j)(2)(ii) of this AD.
(i) Airbus Service Bulletin A320-32-1415, dated September 2, 2014, which was incorporated by reference in AD 2016-06-13.
(ii) Airbus Service Bulletin A320-32-1415, Revision 01, dated April 23, 2015.
The following provisions also apply to this AD:
(1)
(2)
(3)
(1) Refer to Mandatory Continuing Airworthiness Information (MCAI) EASA Airworthiness Directive 2017-0119, dated July 11, 2017, for related information. This MCAI may be found in the AD docket on the internet at
(2) For more information about this AD, contact Sanjay Ralhan, Aerospace Engineer, International Section, Transport Standards Branch, FAA, 2200 South 216th St., Des Moines, WA 98198; telephone and fax 206-231-3223.
(3) For service information identified in this AD, contact Airbus, Airworthiness Office—EIAS, 1 Rond Point Maurice Bellonte, 31707 Blagnac Cedex, France; telephone +33 5 61 93 36 96; fax +33 5 61 93 44 51; email
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 Capital Region International Airport, Lansing, MI. The FAA is proposing this action as a result of an airspace review do to the decommissioning of the Lansing VHF omnidirectional range (VOR) navigation aid as part of the VOR Minimum Operational Network (MON) Program. The geographic coordinates and name of the airport would also be updated to coincide with the FAA's
Comments must be received on or before June 1, 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-2018-0101; Airspace Docket No. 18-AGL-4, at the beginning of your comments. You may also submit comments through the internet at
FAA Order 7400.11B, 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 E airspace extending upward from 700 feet above the surface at Capital Region International Airport, Lansing, MI, to support instrument flight rule operations.
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-2018-0101; Airspace Docket No. 18-AGL-4.” 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 7400.11B, Airspace Designations and Reporting Points, dated August 3, 2017, and effective September 15, 2017. FAA Order 7400.11B 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 E airspace extending upward from 700 feet above the surface to within a 6.8-mile radius (increased from a 6.7-mile radius) at Capital Region International Airport (formerly Capital City Airport), Lansing, MI; removing the extension to the east of the airport associated with the ARTDA LOM; adding an extension within 2 miles each side of the 091° bearing from the airport from the 6.8-mile radius to 10.4 mile east of the airport; and adding an extension within 4 miles each side of the 233° from the airport from the 6.8-mile radius to 10.5 miles southwest of the airport.
The name of the airport would also be updated from Capital City Airport to Capital Region International Airport, and the geographic coordinates of the airport would be updated to coincide with the FAA's aeronautical database. Additionally, an editorial change would be made removing the name of the city associated with the airport in the legal designation to comply with a recent change to FAA Order 7400.2L, Procedures for Handling Airspace Matters.
This action is necessary as the result of airspace review do to the decommissioning of the Lansing VOR as part of the VOR MON Program.
Class E airspace designations are published in paragraph 6005 of FAA Order 7400.11B, dated August 3, 2017, and effective September 15, 2017, 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 regulation only involves an established body of technical regulations for which frequent and routine amendments are
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 6.8-mile radius of Capital Region International Airport, and within 2.0 miles each side of the 091° bearing from the airport extending from the 6.8-mile radius to 10.4 mile east of the airport, and within 4.0 miles each side of the 233° bearing from the airport extending from the 6.8-mile radius to 10.5 miles southwest of the airport.
Federal Aviation Administration (FAA), DOT.
Notice of proposed rulemaking (NPRM).
This action proposes to amend VHF Omnidirectional Range (VOR) Federal airways V-170 and V-219 in the vicinity of Fairmont, MN. The modifications are necessary due to the planned decommissioning of the Fairmont, MN (FRM), VOR navigation aid (NAVAID), which provides navigation guidance for portions of the affected air traffic service (ATS) routes. The Fairmont VOR is being decommissioned as part of the VOR Minimum Operational Network (MON) program.
Comments must be received on or before June 1, 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: 1(800) 647-5527, or (202) 366-9826. You must identify FAA Docket No. FAA-2018-0280; Airspace Docket No. 17-AGL-27 at the beginning of your comments. You may also submit comments through the internet at
FAA Order 7400.11B, 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.
Colby Abbott, Airspace Policy Group, Office of Airspace Services, Federal Aviation Administration, 800 Independence Avenue SW, Washington, DC 20591; telephone: (202) 267-8783.
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 the 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 modify the route structure as necessary to preserve the safe and efficient flow of air traffic within the National Airspace System.
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 (FAA Docket No. FAA-2018-0280; Airspace Docket No. 17-AGL-27) and be submitted in triplicate to the Docket Management Facility (see
Commenters 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-2018-0280; Airspace Docket No. 17-AGL-27.” The postcard will be date/time stamped and returned to the commenter.
All communications received on or before the specified comment closing date will be considered before taking action on the proposed rule. The proposal contained in this action may be changed in light of 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
This document proposes to amend FAA Order 7400.11B, Airspace Designations and Reporting Points, dated August 3, 2017, and effective September 15, 2017. FAA Order 7400.11B is publicly available as listed in the
The FAA is planning decommissioning activities for the Fairmont, MN (FRM), VOR in 2019 as one of the candidate VORs identified for discontinuance by the FAA's VOR MON program and listed in the final policy statement notice, “Provision of Navigation Services for the Next Generation Air Transportation System (NextGen) Transition to Performance-Based Navigation (PBN) (Plan for Establishing a VOR Minimum Operational Network),” published in the
With the planned decommissioning of the Fairmont VOR, the remaining ground-based NAVAID coverage in the area is insufficient to enable the continuity of the affected airways. As such, proposed modifications to V-170 and V-219 would result in gaps in the route structures. To overcome the gaps, instrument flight rules (IFR) traffic could use adjacent VOR Federal airways V-24, V-250, and V-398 between the Worthington, MN, VOR/DME and Rochester, MN, VOR/DME or Federal airways V-100, V-175, V-250, and V-456 between the Sioux City, IA, VOR/Tactical Air Navigation (VORTAC) and Mankato, MN, VOR/DME to circumnavigate the affected area. Additionally, IFR traffic could file point to point through the affected area using fixes that will remain in place, or receive air traffic control (ATC) radar vectors through the area. Visual flight rules pilots who elect to navigate via the airways through the affected area could also take advantage of the adjacent VOR Federal airways or ATC services listed previously.
The FAA is proposing an amendment to Title 14, Code of Federal Regulations (14 CFR) part 71 to modify VOR Federal airways V-170 and V-219. The planned decommissioning of the Fairmont, MN, VOR has made these actions necessary. The proposed VOR Federal airway changes are outlined below.
All radials in the route descriptions below are unchanged and stated in True degrees.
VOR Federal airways are published in paragraph 6010(a) of FAA Order 7400.11B dated August 3, 2017, and effective September 15, 2017, which is incorporated by reference in 14 CFR 71.1. The VOR Federal airways listed in this document would be subsequently published 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 Department of Transportation (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.
From Devils Lake, ND; INT Devils Lake 187° and Jamestown, ND, 337° radials; Jamestown; Aberdeen, SD; Sioux Falls, SD; to Worthington, MN. From Rochester, MN; Nodine, MN; Dells, WI; INT Dells 097° and Badger, WI, 304° radials; Badger; INT Badger 121° and Pullman, MI, 282° radials; Pullman; to Salem, MI. From Bradford, PA; Slate Run, PA; Selinsgrove, PA; Ravine, PA; INT Ravine 125° and Modena, PA, 318° radials; Modena; Dupont, DE; INT Dupont 223° and Andrews, MD, 060° radials; to INT Andrews 060° and Baltimore, MD, 165° radials. The airspace within R-5802 is excluded when active.
From Hayes Center, NE; INT Hayes Center 059° and Wolbach, NE, 251° radials; Wolbach; Norfolk, NE; to Sioux City, IA.
Bureau of Indian Affairs, Interior.
Proposed membership of Committee and request for nominations.
The U.S. Department of the Interior is announcing the proposed members to form the Bureau of Indian Education (BIE) Standards, Assessments, and Accountability System Negotiated Rulemaking Committee (Committee) which will advise the Secretary of the Interior (Secretary) through the BIE on a proposed rule to revise the Adequate Yearly Progress regulation as previously announced in the
Comments must be submitted no later than May 17, 2018.
Send comments and nominations to the Designated Federal Officer, Ms. Sue Bement, Education Program Specialist, Bureau of Indian Education, by any of the following methods:
• (Preferred method) Email to:
• Mail, hand-carry or use an overnight courier service to the Designated Federal Officer, Ms. Sue Bement, c/o The Office of Regulatory Affairs and Collaborative Action, 1001 Indian School Road NW, Suite 312, Albuquerque, NM 87104.
The Designated Federal Officer, Ms. Sue Bement, Bureau of Indian Education; email:
The purpose of the BIE Committee is to serve as an advisory committee under the Federal Advisory Committee Act (FACA) and the Negotiated Rulemaking Act (NRA). Pursuant to the
The Every Student Succeeds Act (ESSA) reauthorizes and amends the Elementary and Secondary Education Act of 1965 (ESEA). ESEA Section 8204, as amended by ESSA directs the Secretary of the Interior, in consultation with the Secretary of Education, if so requested, to use a negotiated rulemaking process to develop regulations for implementation of the Secretary of the Interior's responsibility to define standards, assessments, and an accountability system for Bureau-funded schools. The Committee will recommend regulations that will replace the existing regulations at 25 CFR part 30 and implement the Secretary's new statutory responsibility to define standards, assessments, and an accountability system for Bureau-funded schools consistent with ESEA section 1111, as amended, on a national, regional, or Tribal basis, as appropriate, taking into account the unique circumstances and needs of such schools and the students served by such schools.
ESEA section 8204 also provides that if a Tribal governing body or school board of a Bureau-funded school determines the requirements established by the Secretary of the Interior are inappropriate, they may waive, in part or in whole, such requirements. Where such requirements are waived, the Tribal governing body or school board must, within 60 days, submit to the Secretary of the Interior a proposal for alternative standards, assessments, and an accountability system, if applicable, consistent with ESEA section 1111. The proposal will be approved by the Secretary of the Interior and the Secretary of Education, unless the proposed standards, assessments, and accountability system do not meet the requirements of ESEA section 1111, taking into account the unique circumstances and needs of such school or schools and the students served. Additionally, a Tribal governing body or school board of a Bureau-funded school seeking a waiver may request, technical assistance from the Secretary of the Interior and the Secretary of Education.
The objectives of the Committee are to represent the interests that will be significantly affected by the final regulations, negotiate in good faith, and reach consensus, where possible, on recommendations to the Secretary for the proposed regulations.
The Committee will be charged, consistent with ESEA section 8204, with developing draft regulations to implement the Secretary's responsibility to define the standards, assessments, and an accountability system, consistent with ESEA Section 1111, for Bureau-funded schools. The draft regulations will be considered by the Secretary and subject to government-to-government consultation. As a part of its deliberations, the Committee will consider the appropriate scope of the draft regulations,
The BIE encourages Tribal self-determination in Native education, by encouraging governing Tribes or school boards to develop alternative standards, assessments, and an accountability system, and by providing technical assistance. Therefore, the Committee will also be asked to provide recommendations on how the BIE could best provide technical assistance under ESEA section 8204 to Tribes who opt to exercise their authority to waive in part or in whole the Secretary's definition of standards, assessments, and accountability system.
Since the contemplated regulations must be in place as soon as possible, the Committee will be expected to meet frequently within a short time frame. The BIE currently anticipates up to four meetings, with each meeting lasting two to three days in length. The BIE has dedicated resources required to: Ensure the Committee is able to conduct meetings, provide technical assistance, and provide any additional support required to fulfill the Committee's responsibilities.
On September 14, 2017, the BIE published a
Within the notice, the BIE solicited comments on the proposal to establish the Committee, including comments on any additional interests not identified. The BIE solicited nominations from Tribes whose students attend Bureau-funded schools operated by either BIE or by the Tribe through a contract or grant who would be affected by the final rule to nominate a representative and alternate to serve when the representative is unavailable for membership on the Committee. The BIE also invited nominations for Committee members who will adequately represent the interests that are likely to be significantly affected by the proposed rule such as: Students enrolled, or parents of students enrolled at the 174 Bureau-funded schools, school teachers, and administrators, Tribes, and Indian communities served by these schools.
The proposed Committee was selected based upon nominations submitted through the process identified in the
The Secretary proposes the following Tribal representatives for the Committee:
The Secretary proposes the following alternate Tribal representatives for the Committee:
The Designated Federal Officer for the Committee will be Ms. Sue Bement, Bureau of Indian Education. The Secretary proposes the following Federal representatives for the Committee:
The Secretary proposes the following alternate Federal representatives for the Committee:
The Secretary solicited comments on the proposal to establish the Committee and received one response from the National Indian Education Association (NIEA) that was submitted through the process identified in the
The comments received from NIEA: (1) Support the proposal to form a negotiated rulemaking committee, (2) encourage the Secretary to include Native educators, researchers, and evaluators on the Committee, and (3) encourage the Secretary to ensure that representatives are served by Bureau-funded schools.
Both the Secretary and the BIE believe the proposed representatives address NIEA's comments to ensure the Native students are best supported and evaluated holistically. The proposed representatives carry a wide range of experiences, knowledge, and understanding to support Native students both academically and culturally.
If you are a Tribe with Bureau-funded schools, an Indian education organization, or an interested individual, we invite you to comment on the proposed nominations in this notice or to nominate other persons for membership on the Committee. The Committee membership should reflect the diversity of Tribal interests, and Tribes should nominate representatives and alternates who will:
• Have knowledge of school standards, assessments, and accountability systems;
• Have relevant experiences as past or present superintendents, principals, teachers, or school board members;
• Are able to coordinate, to the extent possible, with other interests who may not be represented on the Committee;
• Are able to represent one or more of the specified interests with the authority to embody the views of that or those interest(s), communicate with interested constituents, and have a clear means to reach agreement on behalf of the interest(s);
• Are able to negotiate effectively on behalf of the interest(s) represented;
• Are able to commit the time and effort required to attend and prepare for meetings; and
• Are able to collaborate among diverse parties in a consensus-seeking process.
The Secretary will consider nominations for representatives only if they are nominated through the process identified in this Notice and in the
Nominations must include the following information about each nominee:
(1) A current letter from the entity representing one of the interest(s) identified supporting the nomination of the individual to serve as a representative for the Committee;
(2) A resume reflecting the nominee's qualifications and experience in Indian education; resume to include the nominee's name, Tribal affiliation (if applicable), job title, major job duties, employer, business address, business telephone and fax numbers (and business email address, if applicable);
(3) The interest(s) to be represented by the nominee identified in Section V, in the
(4) A brief description of how the nominee will represent the views of the identified interest(s), communicate with constituents, and have a clear means to reach agreement on behalf of the interest(s) they are representing; and
(5) A statement on whether the nominee is only representing one interest or whether the expectation is that the nominee represents a specific group of interests.
To be considered, nominations must be received by the close of business on the date 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 nomination submission—including your personal identifying information—may be made publically available at any time. While you can ask us in your submission to withhold your personal identifying information from public review, we cannot guarantee that we will be able to do so.
The Elementary and Secondary Education Act of 1965, as amended, 20 U.S.C. 6301
Coast Guard, DHS.
Notice of proposed rulemaking.
The Coast Guard proposes to establish a special local regulation for certain navigable waters of the Allegheny, Monongahela, and Ohio Rivers in the vicinity of Pittsburgh, PA. This action is necessary to provide for the safety of life on these navigable waters during the weekend of the Luke Bryan concert at Heinz Field. This proposed rulemaking would prohibit persons and vessels from loitering, anchoring, stopping, mooring, remaining, or drifting in any manner
Comments and related material must be received by the Coast Guard on or before May 2, 2018.
You may submit comments identified by docket number USCG-2018-0320 using the Federal eRulemaking Portal at
If you have questions about this proposed rulemaking, call or email Petty Officer Jennifer Haggins, Marine Safety Unit Pittsburgh, U.S. Coast Guard; telephone 412-221-0807, email
Heinz Field notified the Coast Guard that it would be holding a concert from 4 p.m. to 11 p.m. on June 30, 2018. Heinz Field is located in close proximity to the banks of the Ohio and Allegheny Rivers, which is a high vessel traffic area used by both commercial and recreational vessels. Due to the proximity of Heinz Field to these waterways, it will be a destination for many recreational vessels to anchor and loiter throughout the concert weekend of June 29, 2018 to July 1, 2018. The Coast Guard is concerned about possible collisions that could occur in this area and the impact of vessel congestion on maritime commerce due to transit delays. The Captain of the Port Marine Safety Unit Pittsburgh (COTP) has determined that this special local regulation is necessary to maintain an open navigation channel and ensure the safety of vessels and these navigable waters during the concert weekend.
The purpose of this rulemaking is to ensure the safety of vessels and the navigable waters adjacent to Heinz Field on the Allegheny, Monongahela, and Ohio Rivers before, during, and after the Luke Bryan concert weekend. The Coast Guard proposes this rulemaking under authority in 33 U.S.C. 1233.
The Coast Guard is issuing this notice of proposed rulemaking (NPRM) with a 15-day prior notice and opportunity to comment pursuant to section (b)(3) of the Administrative Procedure Act (APA) (5 U.S.C. 553). This provision authorizes an agency to publish a rule in less than 30 days before its effective date for “good cause found and published with the rule.” Under 5 U.S.C. 553(b)(3)(B), the Coast Guard finds that good cause exists for publishing this NPRM with a 15-day comment period because it is impractical to provide a 30-day comment period. This proposed special local regulation is necessary to ensure the safety of vessels and persons during the concert weekend. It is impracticable to publish an NPRM with a 30-day comment period because we must establish this special local regulation by June 29, 2018. A 15-day comment period would allow the Coast Guard to provide for public notice and comment, but also publish a rule, if adopted, soon enough that the length of the notice and comment period does not compromise public safety.
The COTP proposes to establish a special local regulation for all navigable waters of the Allegheny, Monongahela, and Ohio Rivers between the Ninth Street Highway Bridge at mile marker (MM) 0.8, Allegheny River, Fort Pitt Highway Bridge at MM 0.22, Monongahela River, and West End-North Side Highway Bridge at MM 0.8, Ohio River. The duration of the special local regulation is intended to ensure the safety of vessels on these navigable waters before, during, and after the concert weekend. This proposed rule would apply to any vessel operating within the area, including a naval or public vessel, except a vessel engaged in law enforcement, servicing aids to navigation, or surveying, maintaining, or improving waters within the regulated area. No vessel would be permitted to loiter, anchor, stop, moor, remain or drift in any manner that impedes safe passage of another vessel to any launching ramp, marina, or fleeting area unless authorized by the COTP or a designated representative. In addition, no vessel or person would be permitted to loiter, anchor, stop, remain, or drift more than 100 feet from any riverbank unless authorized by the COTP or a designated representative. They may be contacted on VHF-FM Channel 16. Persons and vessels permitted to enter this regulated area must transit at their slowest safe speed and comply with all lawful directions issued by the COTP or the designated representative. The regulatory text we are proposing appears at the end of this document.
We developed this proposed 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 NPRM has not been designated a “significant regulatory action,” under Executive Order 12866. Accordingly, the NPRM 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 size and location of the special local regulation. The special local regulation will impact a small section of the Allegheny, Monongahela, and Ohio Rivers, less than three total miles. Moreover, the special local regulation will not stop vessels from transiting the area, it will only establish certain areas where vessels are prohibited from loitering, anchoring, stopping, remaining, or drifting because it impedes navigation near launching ramps, marinas, and fleeting areas, or commercial traffic in the rivers. Moreover, the Coast Guard would issue Broadcast Notice to Mariners (BNMs) via VHF-FM marine channel 16 about the regulated area and the rule would allow vessels to seek permission to enter the regulated area.
The Regulatory Flexibility Act of 1980, 5 U.S.C. 601-612, as amended, requires Federal agencies to consider
While some owners or operators of vessels intending to transit the regulated area may be small entities, for the reasons stated in section IV.A above, this proposed rule would not have a significant economic impact on any vessel owner or operator.
If you think that your business, organization, or governmental jurisdiction qualifies as a small entity and that this rule would have a significant economic impact on it, please submit a comment (see
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 proposed 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
This proposed rule would 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 proposed 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 proposed rule does not have tribal implications under Executive Order 13175, Consultation and Coordination with Indian Tribal Governments, because it would 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 proposed 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 proposed rule would not result in such an expenditure, we do discuss the effects of this rule elsewhere in this preamble.
We have analyzed this proposed rule under Department of Homeland Security Management Directive 023-01 and Commandant Instruction M16475.lD, which guide the Coast Guard in complying with the National Environmental Policy Act of 1969 (42 U.S.C. 4321-4370f), and have made a preliminary determination 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 proposed rule involves a special local regulation that prohibits vessels from loitering, anchoring, stopping, remaining or drifting more than 100 feet from any bank. Normally such actions are categorically excluded from further review under paragraph L61 of Appendix A, Table 1 of Implementation of the National Environmental Policy Act, Department of Homeland Security Instruction Manual 023-01-001-01. A preliminary environmental analysis checklist and Categorical Exclusion Determination are 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
We view public participation as essential to effective rulemaking, and will consider all comments and material received during the comment period. Your comment can help shape the outcome of this rulemaking. If you submit a comment, please include the docket number for this rulemaking, indicate the specific section of this document to which each comment applies, and provide a reason for each suggestion or recommendation.
We encourage you to submit comments through the Federal eRulemaking Portal at
We accept anonymous comments. All comments received will be posted without change to
Documents mentioned in this NPRM as being available in the docket, and all public comments, will be in our online docket at
Marine safety, Navigation (water), Reporting and recordkeeping requirements, Security measures, Waterways.
For the reasons discussed in the preamble, the Coast Guard proposes to amend 33 CFR part 100 as follows:
33 U.S.C. 1233.
(a)
(b)
(1) Law enforcement;
(2) Servicing aids to navigation; or
(3) Surveying, maintaining, or improving waters within the regulated area.
(c)
(2) No vessel shall loiter, anchor, stop, moor, remain or drift at any time more than 100 feet from any river bank within the regulated area unless authorized by the COTP or a designated representative.
(3) Persons and vessels permitted to enter this regulated area must transit at their slowest safe speed and comply with all lawful directions issued by the COTP or the designated representative.
(4) Persons and vessels permitted to enter this regulated area must transit at their slowest safe speed and comply with all lawful directions issued by the COTP or the designated representative.
(d)
(e)
Coast Guard, DHS.
Notice of proposed rulemaking.
The Coast Guard proposes to amend its safety zone regulations for annual events in Coast Guard Sector Upper Mississippi River. This proposed rule would add one new recurring safety zone, remove four safety zones, and amend the sponsor/name, date, and/or safety zones for three recurring safety zones already listed in the current table. This action is necessary to protect spectators, participants, and vessels from the hazards associated with annual marine events. This proposed rulemaking would restrict vessel traffic from the safety zones during the events unless authorized by the Captain of the Port Sector Upper Mississippi River or a designated representative. We invite your comments on this proposed rulemaking.
Comments and related material must be received by the Coast Guard on or before May 17, 2018.
You may submit comments identified by docket number USCG-2018-0038 using the Federal eRulemaking Portal at
If you have questions on this proposed rule, call or email Lieutenant Commander Sean Peterson, Chief of Prevention, U.S. Coast Guard; telephone (314) 269-2568, email
The Captain of the Port Sector Upper Mississippi River (COTP) proposes to amend 33 CFR 165.801 to update the table of annual fireworks displays and other marine-related events in Coast Guard Sector Upper Mississippi River. The current list of annual and recurring safety zones in Sector Upper Mississippi River is published in Table 2 of 33 CFR 165.801. That most recent table was created through the final rule published on June 21, 2017 (82 FR 28235). The current table in 33 CFR 165.801 needs to be amended to include new safety zones expected to recur annually or biannually, remove safety zones no longer recurring, and provide new information on existing safety zones.
The proposed annually recurring safety zones are necessary to provide for the safety of life on navigable waters during the events. Based on the nature of these marine events, large numbers of participants and spectators, and event locations, the COTP has determined that the events listed in this proposed rule could pose a risk to participants or waterways users if the normal vessel traffic were to interfere with the events. Possible hazards include risks of injury or death from near or actual contact among participant vessels and spectators or mariners traversing through the safety zone. In order to protect the safety of all waterway users, including event participants and spectators, this proposed rule would establish safety zones for the time and location of each marine event.
This purpose of this proposed rulemaking is to ensure the safety of vessels on the navigable waters in the safety zones during the scheduled events. Vessels would not be permitted to enter the safety zone unless authorized by the COTP or a designated representative. The Coast Guard proposes this rulemaking under authority in 33 U.S.C. 1231.
The COTP proposes to amend its safety zone regulations for annual events in Coast Guard Sector Upper Mississippi River listed in Table 2 of 33 CFR 165.801. This section requires amendment from time to time to properly reflect the recurring safety zone regulations in Sector Upper Mississippi River. This rule would add one new recurring safety zone, remove four no longer recurring safety zones, and amend the sponsor/name, date, and/or safety zones for three recurring safety zones already listed in the current table. Other than this one new safety
The Coast Guard proposes to revise regulations at 33 CFR 165.801 Table 2 by adding one new safety zone. The safety zone being added to Table 2 is below:
The Coast Guard also proposes to revise regulations at 33 CFR 165.801 Table 2 by removing the following four existing safety zones that are no longer recurring, with reference by line number to the current Table 2 of 33 CFR 165.801. The four existing safety zones being removed are below:
The Coast Guard also proposes to revise regulations at 33 CFR 165.801 Table 2 by amending three existing safety zones listed in the current table. The amendments involve changes to marine event sponsor/name and/or safety zones, with reference by line number to the current Table 2 of 33 CFR 165.801. The three safety zones being amended are below:
This proposed rule modifies the following three safety zones from the existing Table 2 in § 165.801 as follows:
The amendments to this rule are necessary to ensure the safety of vessels and people during annual events taking place on or near navigable waters in Sector Upper Mississippi River. Although this proposed rule would be in effect year-round, the specific safety zones listed in Table 2 of 33 CFR 165.801 would only be enforced during a specified period of time coinciding with the happening of the annual events listed. In accordance with the regulations listed in 33 CFR 165.801(a)-(d), entry into these safety zones is prohibited unless authorized by the COTP or a designated representative. The regulatory text of the updated Table 2 of § 165.801 we are proposing appears at the end of this document.
We developed this proposed 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 NPRM has not been designated a “significant regulatory action,” under Executive Order 12866. Accordingly, the NPRM 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 size, location, and duration of the safety zones. These safety zones are limited in size and duration, and are usually positioned away from high vessel traffic zones. Moreover, the Coast Guard would issue a Broadcast Notice to Mariners via VHF-FM marine channel 16 about the zones, and the rule would allow vessels to seek permission to enter the zones.
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 proposed rule would 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 IV.A above, this proposed rule would not have a significant economic impact on any vessel owner or operator.
If you think that your business, organization, or governmental jurisdiction qualifies as a small entity and that this rule would have a significant economic impact on it, please submit a comment (see
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 proposed 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
This proposed rule would 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 proposed 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 proposed rule does not have tribal implications under Executive Order 13175, Consultation and Coordination with Indian Tribal Governments, because it would 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 proposed 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 proposed rule would not result in such an expenditure, we do discuss the effects of this rule elsewhere in this preamble.
We have analyzed this proposed rule under Department of Homeland Security Directive 023-01 and Commandant Instruction M16475.lD, which guide the Coast Guard in complying with the National Environmental Policy Act of 1969 (42 U.S.C. 4321-4370f), and have made a preliminary determination 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 proposed rule involves establishing safety zones limiting access to certain areas under 33 CFR 165 within the COTP Zone. Normally such actions are 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
We view public participation as essential to effective rulemaking, and will consider all comments and material received during the comment period. Your comment can help shape the outcome of this rulemaking. If you submit a comment, please include the docket number for this rulemaking, indicate the specific section of this document to which each comment applies, and provide a reason for each suggestion or recommendation.
We encourage you to submit comments through the Federal eRulemaking Portal at
We accept anonymous comments. All comments received will be posted without change to
Documents mentioned in this NPRM as being available in the docket, and all public comments, will be in our online docket at
Harbors, Marine safety, Navigation (water), Reporting and recordkeeping requirements, Security measures, Waterways.
For the reasons discussed in the preamble, the U.S. Coast Guard proposes to amend 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.
Coast Guard, DHS.
Notice of proposed rulemaking.
The Coast Guard proposes to establish a temporary safety zone for certain navigable waters of the Tchefuncte River. This action is necessary to provide for the safety of life on these navigable waters near Madisonville, LA, during a fireworks display on July 4, 2018. This proposed rulemaking would prohibit persons and vessels from being in the safety zone unless authorized by the Captain of the Port Sector New Orleans or a designated representative. We invite your comments on this proposed rulemaking.
Comments and related material must be received by the Coast Guard on or before May 17, 2018.
You may submit comments identified by docket number USCG-2018-0332 using the Federal eRulemaking Portal at
If you have questions on this rule, call or email Lieutenant Commander Howard Vacco, Sector New Orleans, U.S. Coast Guard; telephone 504-365-2281, email
On April 4, 2018, Geaux Pyro notified the Coast Guard that it would conduct a fireworks display from 7 p.m. through 7:20 p.m. on July 4, 2018, for a wedding celebration. The fireworks are to be launched from a barge on the Tchefuncte River, at approximate position 30°24′11.63″ N 090°09′17.39″ W, in front of the Madisonville Town Hall. Hazards from firework displays include accidental discharge of fireworks, dangerous projectiles, and falling hot embers or other debris. The Captain of the Port Sector New Orleans (COTP) has determined that potential hazards associated with the fireworks to be used in this display would be a safety concern for anyone within 100 yards of the launch barge.
The purpose of this rulemaking is to ensure the safety of vessels and the navigable waters within a 100-yard
The COTP proposes to establish a safety zone from 6:45 p.m. through 7:45 p.m. on July 4, 2018. The safety zone would cover all navigable waters of the Tchefuncte River within 100-yards of a barge at approximate position 30°24′11.63″ N 090°09′17.39″ W, in front of the Madisonville Town Hall in Madisonville, LA. The duration of the zone is intended to ensure the safety of vessels and these navigable waters before, during, and after the scheduled 7 p.m. to 7:20 p.m. fireworks display. No vessel or person would be permitted to enter the safety zone without obtaining permission from the COTP or a designated representative. A designated representative is a commissioned, warrant, or petty officer of the U.S. Coast Guard assigned to units under the operational control of USCG Sector New Orleans.
Vessels requiring entry into this safety zone must request permission from the COTP or a designated representative. They may be contacted on VHF-FM Channel 16 or 67 or by telephone at (504) 365-2200. Persons and vessels permitted to enter this safety zone must transit at their slowest safe speed and comply with all lawful directions issued by the COTP or the designated representative. The regulatory text we are proposing appears at the end of this document.
We developed this proposed 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 NPRM has not been designated a “significant regulatory action,” under Executive Order 12866. Accordingly, the NPRM 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 size and duration of the safety zone. This proposed safety zone would only encompass a 100-yard radius of the Tchefuncte River for one hour on one evening. Moreover, the Coast Guard would issue a Broadcast Notice to Mariners via VHF-FM marine channel 16 about the zone, and the proposed rule would allow vessels to seek permission to enter the zone.
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 proposed rule would 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 IV.A above, this proposed rule would not have a significant economic impact on any vessel owner or operator.
If you think that your business, organization, or governmental jurisdiction qualifies as a small entity and that this rulemaking would have a significant economic impact on it, please submit a comment (see
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 proposed rule. If the rulemaking 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
This proposed rule would 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 proposed 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 proposed rule does not have tribal implications under Executive Order 13175, Consultation and Coordination with Indian Tribal Governments, because it would 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 proposed 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 proposed rule would not result in such an expenditure, we do discuss the effects of this rule elsewhere in this preamble.
We have analyzed this proposed 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 made a preliminary determination 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 proposed rule involves a safety zone lasting one hour that would prohibit entry within a 100-yard radius of a barge at approximate position of 30°24′11.63″ N 090°09′17.39″ W on the Tchefuncte River. Normally
The Coast Guard respects the First Amendment rights of protesters. Protesters are asked to contact the person listed in the
We view public participation as essential to effective rulemaking, and will consider all comments and material received during the comment period. Your comment can help shape the outcome of this rulemaking. If you submit a comment, please include the docket number for this rulemaking, indicate the specific section of this document to which each comment applies, and provide a reason for each suggestion or recommendation.
We encourage you to submit comments through the Federal eRulemaking Portal at
We accept anonymous comments. All comments received will be posted without change to
Documents mentioned in this NPRM as being available in the docket, and all public comments, will be in our online docket at
Harbors, Marine safety, Navigation (water), Reporting and recordkeeping requirements, Security measures, Waterways.
For the reasons discussed in the preamble, the Coast Guard proposes to amend 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) Vessels requiring entry into this safety zone must request permission from the COTP or a designated representative. They may be contacted on VHF-FM Channel 16 or 67 or by telephone at (504) 365-2200.
(3) Persons and vessels permitted to enter this safety zone must transit at their slowest safe speed and comply with all lawful directions issued by the COTP or the designated representative.
(d)
Coast Guard, DHS.
Notice of proposed rulemaking.
The Coast Guard proposes to establish a temporary safety zone for certain navigable waters of the Mississippi River from mile marker (MM) 94 to MM 95 above Head of Passes. This action is necessary to provide for the safety of life on these navigable waters near Algiers Point, New Orleans, LA, during a fireworks display on June 30, 2018. This proposed rulemaking would prohibit persons and vessels from being in the safety zone unless authorized by the Captain of the Port Sector New Orleans or a designated representative. We invite your comments on this proposed rulemaking.
Comments and related material must be received by the Coast Guard on or before May 17, 2018.
You may submit comments identified by docket number USCG-2018-0331 using the Federal eRulemaking Portal at
If you have questions about this proposed rulemaking, call or email Lieutenant Commander Howard Vacco, Sector New Orleans, U.S. Coast Guard; telephone 504-365-2281, email
On April 4, 2018, AFX Pro, LLC, notified the Coast Guard that it would
The purpose of this rulemaking is to ensure the safety of vessels on the navigable waters within a one-mile stretch of the river before, during, and after the fireworks display. The Coast Guard proposes this rulemaking under authority in 33 U.S.C. 1231.
The COTP proposes to establish a safety zone from 9:45 p.m. through 11 p.m. on June 30, 2018. The safety zone would cover all navigable waters of the Mississippi River above Head of Passes between mile markers (MM) 94 and 95. The duration of the zone is intended to ensure the safety of vessels and these navigable waters before, during, and after the scheduled fireworks display. No vessel or person would be permitted to enter the safety zone without obtaining permission from the COTP or a designated representative. A designated representative is a commissioned, warrant, or petty officer of the U.S. Coast Guard assigned to units under the operational control of USCG Sector New Orleans.
Vessels requiring entry into this safety zone must request permission from the COTP or a designated representative. They may be contacted on VHF-FM Channel 16 or 67 or by telephone at (504) 365-2200. Persons and vessels permitted to enter this safety zone must transit at their slowest safe speed and comply with all lawful directions issued by the COTP or a designated representative. The regulatory text we are proposing appears at the end of this document.
We developed this proposed 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 NPRM has not been designated a “significant regulatory action,” under Executive Order 12866. Accordingly, the NPRM 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 size and duration of the safety zone. This safety zone is for only one hour on a one-mile section of the waterway. Moreover, the Coast Guard would issue a Broadcast Notice to Mariners (BNM) via VHF-FM marine channel 16 about the zone, and the rule would allow vessels to seek permission to enter the zone.
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 proposed rule would 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 IV.A above, this proposed rule would not have a significant economic impact on any vessel owner or operator.
If you think that your business, organization, or governmental jurisdiction qualifies as a small entity and that this proposed rule would have a significant economic impact on it, please submit a comment (see
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 proposed rule. If the rulemaking 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
This proposed rule would 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 proposed 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 proposed rule does not have tribal implications under Executive Order 13175, Consultation and Coordination with Indian Tribal Governments, because it would 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 proposed 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 proposed rule would not result in such an expenditure, we do discuss the effects of this rule elsewhere in this preamble.
We have analyzed this proposed rule under Department of Homeland
The Coast Guard respects the First Amendment rights of protesters. Protesters are asked to contact the person listed in the
We view public participation as essential to effective rulemaking, and will consider all comments and material received during the comment period. Your comment can help shape the outcome of this rulemaking. If you submit a comment, please include the docket number for this rulemaking, indicate the specific section of this document to which each comment applies, and provide a reason for each suggestion or recommendation.
We encourage you to submit comments through the Federal eRulemaking Portal at
We accept anonymous comments. All comments received will be posted without change to
Documents mentioned in this NPRM as being available in the docket, and all public comments, will be in our online docket at
Harbors, Marine safety, Navigation (water), Reporting and recordkeeping requirements, Security measures, Waterways.
For the reasons discussed in the preamble, the Coast Guard proposes to amend 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) Vessels requiring entry into this safety zone must request permission from the COTP or a designated representative. They may be contacted on VHF-FM Channel 16 or 67 or by telephone at (504) 365-2200.
(3) Persons and vessels permitted to enter this safety zone must transit at their slowest safe speed and comply with all lawful directions issued by the COTP or the designated representative.
(d)
Fish and Wildlife Service, Interior.
Notice of petition findings and initiation of a status review.
We, the U.S. Fish and Wildlife Service (Service), announce 90-day findings on two petitions to list, reclassify, or delist wildlife or plants under the Endangered Species Act of 1973, as amended (Act). Based on our review, we find that one petition presents substantial scientific or commercial information indicating that the petitioned action may be warranted. Therefore, with the publication of this document, we announce that we plan to initiate a review of the status of that species to determine if the petitioned action is warranted. To ensure that this status review is comprehensive, we are requesting scientific and commercial data and other information regarding this species. Based on the status review, we will issue a 12-month finding on the petition, which will address whether or not the petitioned action is warranted, in accordance with the Act. We also find that one petition does not present substantial scientific or commercial information indicating that the petitioned action may be warranted. Therefore, we are not initiating a status review of this species in response to that petition. We refer to this finding as a “not substantial” petition finding.
These findings were made on April 17, 2018. As we commence work on the status review, we seek any new information concerning the status of, or threats to, the species or its habitat. Any information received during our work on the status review will be considered.
(1)
(2)
We request that you send information only by the methods described above. We will post all information we receive on
If you use a telecommunications device for the deaf (TDD), please call the Federal Relay Service at 800-877-8339.
Section 4 of the Act (16 U.S.C. 1533) and its implementing regulations in title 50 of the Code of Federal Regulations (50 CFR part 424) set forth the procedures for adding a species to, or removing a species from, the Federal Lists of Endangered and Threatened Wildlife and Plants (Lists). Section 4(b)(3)(A) of the Act requires that we make a finding on whether a petition to add a species to the Lists (
Our regulations in the Code of Federal Regulations (CFR) establish that substantial scientific or commercial information with regard to a 90-day petition finding refers to “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” (50 CFR 424.14(h)(1)(i)).
A species may be determined to be an endangered or threatened species because of one or more of the five factors described in section 4(a)(1) of the Act (16 U.S.C 1531
(a) The present or threatened destruction, modification, or curtailment of its habitat or range (Factor A);
(b) Overutilization for commercial, recreational, scientific, or educational purposes (Factor B);
(c) Disease or predation (Factor C);
(d) The inadequacy of existing regulatory mechanisms (Factor D); or
(e) Other natural or manmade factors affecting its continued existence (Factor E).
We use the term “threat” to refer in general to actions or conditions that are known to or are reasonably likely to negatively affect individuals of a species. The term “threat” includes actions or conditions that have a direct impact on individuals (direct impacts), as well as those that affect individuals through alteration of their habitat or required resources (stressors). The term “threat” may encompass—either together or separately—the source of the action or condition or the action or condition itself. However, the mere identification of any threat(s) may not be sufficient to compel a finding that the information in the petition is substantial information indicating that the petitioned action may be warranted. The information presented in the petition must include evidence sufficient to suggest that these threats may be affecting the species to the point that the species may meet the definition of an “endangered” species or “threatened” species under the Act.
If we find that a petition presents such information, our subsequent status review will evaluate all identified threats by considering the individual, population, and species-level effects, and the expected response by the species. We will evaluate individual threats and their expected effects on the species, then analyze the cumulative effect of the threats on the species as a whole. We also consider the cumulative effect of the threats in light of those actions and conditions that will have positive effects on the species—such as
If we find that a petition presents substantial scientific or commercial information, the Act requires us to promptly commence a review of the status of the species, and we will subsequently complete a status review in accordance with our prioritization methodology for 12-month findings (81 FR 49248; July 27, 2016).
The petition findings contained in this document are listed in the tables below and the bases for the findings, along with supporting information, are available on
Cape mountain zebra (
On May 10, 2017, we received a petition dated May 10, 2017, from Conservation Force and the Professional Hunters Association of South Africa requesting that we delist the Cape mountain zebra (
Based on our review of the petition and sources cited in the petition, we find that the petition presents substantial scientific or commercial information indicating that the petitioned action may be warranted for the Cape mountain zebra due to the reduction or elimination of threats related to the following: Habitat availability (Factor A); commercial and recreational use (Factor B); disease and predation (Factor C); hybridization and inbreeding (Factor E); and the inadequacy of existing regulations with regards to a number of these threats (Factor D) (for information about these factors, see Background, above). However, during our status review, we will thoroughly evaluate all potential threats to the subspecies, including the extent to which any protections or other conservation efforts have reduced those threats. Thus, for this subspecies, the Service requests any information relevant to whether the subspecies falls within the definition of either “endangered species” under section 3(6) of the Act or “threatened species” under section 3(20) of the Act, including information on the five listing factors under section 4(a)(1) (see Request for Information for Status Reviews, below).
The basis for our finding on this petition, and other information regarding our review of the petition, can be found as an appendix at
Preble's meadow jumping mouse (
On March 30, 2017, we received a petition dated March 29, 2017, from Pacific Legal Foundation (on behalf of Dr. Rob Roy Ramey II; Center for Environmental Science, Accuracy and Reliability; Wyoming Stock Growers Association; Colorado Cattlemen's Association; Colorado Association of Home Builders; and Housing and Building Association of Colorado Springs), requesting that the Preble's meadow jumping mouse be delisted under the Act due to an error in taxonomic information. The petition clearly identified itself as such and included the requisite identification information for the petitioners, required at 50 CFR 424.14(c). This finding addresses the petition.
Based on our review of the petition and the source cited in the petition, we find that the petition presents no additional or new information that would support a taxonomic revision for the Preble's mouse or that would indicate that the subspecies is not a valid entity under the Act. Therefore, we find that the petition does not present substantial scientific or commercial information indicating that delisting the Preble's meadow jumping mouse may be warranted. Because the petition does not present substantial information indicating that delisting the Preble's meadow jumping mouse may be warranted, we are not initiating a status review of this species in response to this petition. However, we ask that the public submit to us any new information that becomes available concerning the status of, or threats to, this species or its habitat at any time (see
The basis for our finding on this petition, and other information regarding our review of this petition, can be found as an appendix at
When we make a finding that a petition presents substantial
(1) The species' biology, range, and population trends, including:
(a) Habitat requirements;
(b) Genetics and taxonomy;
(c) Historical and current range, including distribution patterns; and
(d) Historical and current population levels and current and projected trends.
(2) The five factors described in section 4(a)(1) of the Act (see Background, above) that are the basis for making a listing, reclassification, or delisting determination for a species under section 4(a) of the Act, including past and ongoing conservation measures that could decrease the extent to which one or more of the factors affect the species, its habitat, or both.
(3) The potential effects of climate change on the species and its habitat, and the extent to which it affects the habitat or range of the species.
Submissions merely stating support for or opposition to the actions under consideration without providing supporting information, although noted, will not be considered in making a determination. Section 4(b)(1)(A) of the Act directs that determinations as to whether any species is an endangered or threatened species must be made “solely on the basis of the best scientific and commercial data available.”
You may submit your information concerning the status review by one of the methods listed in
It is important to note that the standard for a 90-day finding differs from the Act's standard that applies to a status review to determine whether a petitioned action is warranted. In making a 90-day finding, we consider information in the petition and sources cited in the petition, as well as information that is readily available, and we evaluate merely whether that information constitutes “substantial information” indicating that the petitioned action “may be warranted.” In a 12-month finding, we must complete a thorough status review of the species and evaluate the “best scientific and commercial data available” to determine whether a petitioned action “is warranted.” Because the Act's standards for 90-day and 12-month findings are different, a substantial 90-day finding does not mean that the 12-month finding will result in a “warranted” finding.
On the basis of our evaluation of the information presented in the petitions under section 4(b)(3)(A) of the Act, we have determined that the petition summarized above for the Cape mountain zebra presents substantial scientific or commercial information indicating that the petitioned action may be warranted. We are, therefore, initiating a status review to determine whether the action is warranted under the Act. At the conclusion of the status review, we will issue a finding, in accordance with section 4(b)(3)(B) of the Act, as to whether the petitioned action is not warranted, warranted, or warranted but precluded by pending proposals to determine whether any species is an endangered species or a threatened species.
In addition, we have determined that the petition summarized above for the Preble's meadow jumping mouse does not present substantial scientific or commercial information indicating that the requested actions may be warranted. Therefore, we are not initiating a status review for this species.
The primary authors of this document are staff members of the Ecological Services Program, U.S. Fish and Wildlife Service.
The authority for these actions is the Endangered Species Act of 1973, as amended (16 U.S.C. 1531
Pursuant to the Federal Advisory Committee Act, notice is hereby given of the public meeting of the Board for International Food and Agricultural Development (BIFAD). The meeting will be held from 9:00 a.m. to 5:00 p.m. ET on Wednesday, May 9, 2018, at the Rotunda, Ronald Reagan Building and International Trade Center, 1300 Pennsylvania Ave. NW, Washington, DC. Participants may attend in person or join via livestream. The link to the global live stream as well as registration information can be found on BIFAD's home page:
The central theme of this public meeting will be
The meeting will be chaired by Dr. Brady Deaton, Acting BIFAD Chair and Chancellor Emeritus of the University of Missouri. The meeting will feature thought leaders on resilience measurement and analysis from USAID, academia and the practitioner community. Speakers include Dr. Greg Collins, Director of USAID's Center for Resilience and Dr. Mark Constas, Associate Professor at Cornell University, and Chair of the Food and Nutrition Security Resilience Measurement Technical Working Group.
At 4:00 p.m. ET, Acting Chairman Deaton will moderate a half-hour public comment period. At 5:00 p.m., Dr. Deaton will make closing remarks and adjourn the public meeting.
Those wishing to attend the meeting or obtain additional information about BIFAD should contact Clara Cohen, Designated Federal Officer for BIFAD in the Bureau for Food Security at USAID. Interested persons may write to her in care of the U.S. Agency for International Development, Ronald Reagan Building, Bureau for Food Security, 1300 Pennsylvania Avenue NW, Washington, DC, 20523-2110 or telephone her at (202) 712-0119.
Pursuant to the Federal Advisory Committee Act, notice is hereby given of the public meeting of the Board for International Food and Agricultural Development (BIFAD). The meeting will be held from 9:00 a.m. to 5:00 p.m. ET on Tuesday, May 8, 2018, at the Rotunda, Ronald Reagan Building and International Trade Center, 1300 Pennsylvania Ave. NW, Washington, DC. Participants may attend in person or join via livestream. The link to the global live stream as well as registration information can be found on BIFAD's home page:
The central theme of this public meeting will be
Following the opening remarks, the meeting will feature experts as well as panel discussions on the following topics:
• A Conceptual Framework on Youth and Agricultural Transformation;
• Framing the Evidence Base on Rural Youth Employment and Livelihoods;
• Youth Perspectives: Challenges and Opportunities in the Agricultural and Food Sectors;
• Youth Productivity: Technology, Mechanization, and Global Value Chains;
• Gender Considerations and Youth Employment;
• Research, Learning and USAID Programming: The Role of U.S. University Research Partners in Generating Evidence.
The meeting will be chaired by Dr. Brady Deaton, Acting BIFAD Chair and Chancellor Emeritus of the University of Missouri. Expert speakers include Dr. Louise Fox, USAID Chief Economist and Dr. David Tschirley, Food Security Group Co-Director, Michigan State University.
At 4:15 p.m. ET, Acting Chairman Deaton will moderate a half-hour public comment period. At 5:00 p.m., Dr. Deaton will make closing remarks and adjourn the public meeting.
Those wishing to attend the meeting or obtain additional information about BIFAD should contact Clara Cohen, Designated Federal Officer for BIFAD in the Bureau for Food Security at USAID. Interested persons may write to her in care of the U.S. Agency for International Development, Ronald Reagan Building, Bureau for Food Security, 1300 Pennsylvania Avenue NW, Washington,
Agricultural Research Service, USDA.
Notice of intent.
Notice is hereby given that the U.S. Department of Agriculture, Agricultural Research Service, intends to grant to Koppert B.V. of The Netherlands, an exclusive license to U.S. Patent Application Serial No. 14/854,120, “STABLE FUNGAL BLASTOSPORES AND METHODS FOR THEIR PRODUCTION, STABILIZATION AND USE”, filed on September 15, 2015.
Comments must be received on or before May 17, 2018.
Send comments to: USDA, ARS, Office of Technology Transfer, 5601 Sunnyside Avenue, Rm. 4-1174, Beltsville, Maryland 20705-5131.
Brian T. Nakanishi of the Office of Technology Transfer at the Beltsville address given above; telephone: 301-504-5989.
The Federal Government's patent rights in this invention are assigned to the United States of America, as represented by the Secretary of Agriculture. It is in the public interest to so license this invention as Koppert B.V. of The Netherlands has submitted a complete and sufficient application for a license. The prospective exclusive license will be royalty-bearing and will comply with the terms and conditions of 35 U.S.C. 209 and 37 CFR 404.7. The prospective exclusive license may be granted unless, within thirty (30) days from the date of this published Notice, the Agricultural Research Service receives written evidence and argument which establishes that the grant of the license would not be consistent with the requirements of 35 U.S.C. 209 and 37 CFR 404.7.
Forest Service, USDA.
Notice.
In accordance with the Comprehensive Environmental Response, Compensation, and Liability Act, as amended (CERCLA), notice is hereby given of an administrative settlement with W.R. Grace & Co. Conn. and the Kootenai Development Company (Grace) for the recovery of past response costs concerning Operable Unit 3 (OU3) of the Libby Asbestos Site, Lincoln County, Montana (the Site).
Comments must be submitted on or before May 17, 2018.
The proposed settlement is available for public inspection at the Libby Ranger District, Canoe Gulch Ranger Station, 12557 MT Hwy. 37, Libby, MT 59923, and at the offices of the USDA Forest Service, Northern Region, 26 Fort Missoula Road, Missoula, MT 59804. A copy of the proposed settlement may be obtained from Jeff Johnson at (208) 765-7313, Pamela Baltz (406) 283-7597, or from Babak Rastgoufard, USDA Office of the General Counsel at (406) 329-3061. Comments should reference the Libby Asbestos Site OU3, and should be addressed to Babak Rastgoufard, USDA Office of the General Counsel, 26 Fort Missoula Road, Missoula, MT 59804.
For technical information, contact Jeff Johnson, USDA Forest Service Northern Region, 3815 N Schreiber Way, Coeur d'Alene, ID 83815; phone (208) 765-7313 or Pamela Baltz, Kootenai National Forest, 12557 Hwy. 37, Libby, MT 59923; phone (406) 283-7597. For legal information, contact Babak Rastgoufard, USDA Office of the General Counsel, 26 Fort Missoula Road, Missoula, MT 59804; phone (406) 329-3061.
Pursuant to section 122(h)(1) of CERCLA, 42 U.S.C. 9622(h)(1), the settlement agreement resolves, in part, response costs incurred by the Forest Service at OU3. Under the settlement, Grace has agreed to pay the USDA Forest Service, Northern Region, $219,308 to reimburse it for certain response actions the USDA Forest Service, Northern Region, has undertaken at the Site. The settlement includes a covenant not to sue Grace for certain past costs pursuant to sections 106 and 107(a) of CERCLA, 42 U.S.C. 9606 and 9607(a), with regard to the Site.
For thirty (30) days following the date of publication of this notice, the United States will receive written comments relating to the settlement. The United States will consider all comments received and may modify or withdraw its consent to the settlement if comments received disclose facts or considerations which indicate that the settlement is inappropriate, improper, or inadequate. The United States response to any comments received will be available for public inspection at the Libby Ranger District, Canoe Gulch Ranger Station, 12557 MT Hwy. 37, Libby, MT 59923, and at the offices of the USDA Forest Service, Northern Region, 26 Fort Missoula Road, Missoula, MT 59804.
Forest Service, USDA.
Notice; request for comment.
In accordance with the Paperwork Reduction Act of 1995, the Forest Service is seeking comments from all interested parties on the extension of a currently approved information collection,
Comments must be received in writing on or before June 18, 2018 to be assured of consideration. Comments received after that date will be considered to the extent practicable.
Comments concerning this notice should be addressed to Director, Forest & Rangeland Management and Vegetation Ecology, Forest Service, USDA, Mail Stop 1103, 1400 Independence Avenue SW, Washington DC 20250-1103.
Comments may also be submitted via facsimile to (703) 605-1575 or by email
The public may inspect comments received at the Forest Service, Forest Management Staff Office, Third Floor SW Wing, 201 14th Street SW, Washington, DC 20250 during normal business hours. Visitors are encouraged to call ahead to (202) 205-1766 to facilitate entry to the building.
Sharon Nygaard-Scott, Forest Management Staff, at (202) 205-1766. Individuals who use telecommunication devices for the deaf (TDD) may call the Federal Relay Service (FRS) at 1-800-877-8339 twenty-four hours a day, every day of the year, including holidays.
Under the
Indian tribes seeking products, under section 8105 authority, must make a request for free use, following the criteria at 36 CFR 223.15, which includes: “Requests for trees, portions of trees, or forest products . . . must be submitted to the local Forest Service District Ranger's Office(s) in writing. Requests may be made: (1) Directly by a tribal official(s) who has been authorized by the Indian tribe to make such requests; or (2) By providing a copy of a formal resolution approved by the tribal council or other governing body of the Indian tribe.” Note: there is no stated maximum free use limitation for products requested by Indian tribes, and there is no limitation to the number of requests that each federally recognized Indian tribe may make, under section 8105 authority. Should federally recognized Indian tribes seeking such use wish to obtain proof of possession, as may be required in some States, they could be issued a FS-2400-8 permit which allows use of timber or forest products at no charge (36 CFR 223.5-223.13).
Upon receiving a permit, the permittee must comply with the terms of the permit (36 CFR 261.6), which designates the forest products that can be harvested and under what conditions, such as limiting harvest to a designated area or permitting harvest of only specifically designated material. The collected information will help the Forest Service and the Bureau of Land Management (for form FS-2400-1) oversee the approval and use of forest products by the public.
When applying for forest product removal permits, applicants (depending on the products requested) would provide information needed to complete one of the following:
• FS-2400-1,
• FS-2400-4/FS-2400-4ANF,
• FS-2400-8,
Each form listed above implements different regulations and has different provisions for compliance, but collects similar information from the applicant for related purposes.
The Forest Service and the Bureau of Land Management will use the information collected on form FS-2400-1, to ensure identification of permittees in the field by agency personnel. The Forest Service will use the information collected on forms FS-2400-4/FS-2400-4ANF and/or FS-2400-8 to:
• Ensure that permittees obtaining free use of timber or forest products qualify for the free-use program.
• Ensure that permittees obtaining free use of timber or forest products, under 36 CFR 223.8, do not receive product value in excess of that allowed by regulations. However, as noted above for federally recognized Indian Tribe requests made under section 8105 authority, there is no stated maximum free use limitation (25 U.S.C. 3055).
• Ensure that applicants purchasing timber harvest or forest products permits non-competitively do not exceed the authorized limit in a fiscal year (16 U.S.C. 472(a)).
• Ensure identification of permittees, in the field, by Forest Service personnel.
Applicants may apply for more than one forest product permit or contract per year. For example, an applicant may obtain a free use permit for a timber product such as, but not limited to, pine cones (FS-2400-8) and still purchase fuelwood (FS-2400-1, and/or FS-2400-4/2400-4ANF). Additionally, as noted above, there is no limitation to the number of requests that each federally recognized Indian tribe may make under section 8105 authority (25 U.S.C. 3055).
Individuals and small business representatives usually request and apply for permits and contracts in person at the office issuing the permit. As noted above, Indian tribes seeking products under section 8105 authority must make a written request for free use, following the criteria at 36 CFR 223.15.
Applicants provide the following information, as applicable:
• Name,
• Address, and
• Personal identification number such as tax identification number, social security number, driver's license number, or other unique number identifying the applicant.
Agency personnel enter the information into a computerized database to use for subsequent requests by applicants for a forest product permit or contract. The information is printed on paper, which the applicant signs and dates. Agency personnel discuss the
The data gathered is not available from other sources. The collected data is used to ensure:
• Applicants for free use permits meet the criteria for free use of timber or forest products authorized by regulations at 36 CFR 223.5-223.13; and, for federally recognized Indian tribes under section 8105 authority, the criteria at 36 CFR 223.15;
• Applicants seeking to purchase and remove timber or forest products from Agency lands meet the criteria under which sale of timber or forest products is authorized by regulations at 36 CFR 223.80; and
• Permittees comply with regulations and terms of the permit at 36 CFR 261.6.
The collection of this information is necessary to ensure that applicants meet the requirements of the forest products program; those obtaining free-use permits for forest products qualify for the program; applicants purchasing non-competitive permits to harvest forest products do not exceed authorized limits; and that Federal Agency employees can identify permittees when in the field.
All comments received in response to this notice, including names and addresses when provided, will be a matter of public record. Comments will be summarized and included in the submission request toward Office of Management and Budget approval.
U.S. Commission on Civil Rights.
Announcement of 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 that the Oregon Advisory Committee (Committee) will hold a community forum on Tuesday, May 1, 2018, from 2:00 p.m.-5:00 p.m. PST for the purpose of hearing public testimony on civil rights concerns of human and labor trafficking in the sex, agriculture, and forestry industries and equal protection violations and discrimination based upon race, national origin, religion, sex, disability, and/or age of survivors. It will also examine the effectiveness of state and local agency programs for trafficking survivors.
The meeting will be held on Tuesday, May 1, 2018, at 2:00 p.m. PST to 5:00 p.m. PST.
Ana Victoria Fortes (DFO) at
Members of the public are entitled to make comments during the open comment periods. Members of the public may also submit written comments; the comments must be received in the Regional Programs Unit within 30 days following the meeting. Written comments may be mailed to the Western Regional Office, U.S. Commission on Civil Rights, 300 North Los Angeles Street, Suite 2010, Los Angeles, CA 90012. They may be faxed to the Commission at (213) 894-0508, or emailed Ana Victoria Fortes at
Records and documents discussed during the meeting will be available for public viewing prior to and after the meeting at
Commission on Civil Rights.
Announcement of meetings.
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 planning meeting of the Rhode Island State Advisory Committee to the Commission will convene by conference call, on Tuesday, May 1, 2018 at 11:00 a.m. (EDT). The purpose of the meeting is to review and vote on a work product generated at the Committee's briefing on Predatory
Tuesday, May 1, 2018, at 11:00 a.m. (EDT).
Evelyn Bohor, at
Interested members of the public may listen to the discussion by calling the following toll-free conference call number: 1-888-334-3020 and conference call ID: 8405258. Please be advised that before placing them into the conference call, the conference call operator may 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 herein.
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:1-888-334-3020 and conference call ID: 8405258.
Members of the public are invited to 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 Eastern Regional Office, U.S. Commission on Civil Rights, 1331 Pennsylvania Avenue, Suite 1150, Washington, DC 20425, or emailed to Evelyn Bohor at
Records and documents discussed during the meeting will be available for public viewing as they become available at
U.S. Commission on Civil Rights.
Announcement of 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 that the Oregon Advisory Committee (Committee) will hold a community forum on Wednesday, May 2, 2018, from 2:00 p.m.-5:00 p.m. PST for the purpose of hearing public testimony on civil rights concerns of human and labor trafficking in the sex, agriculture, and forestry industries and equal protection violations and discrimination based upon race, national origin, religion, sex, disability, and/or age of survivors. It will also examine the effectiveness of state and local agency programs for trafficking survivors.
The meeting will be held on Wednesday, May 2, 2018, at 2:00 p.m. PST to 5:00 p.m. PST.
Chemeketa Woodburn Center, Room 110, 120 E Lincoln Street, Woodburn, OR 97071.
Ana Victoria Fortes (DFO) at
Members of the public are entitled to make comments during the open comment periods. Members of the public may also submit written comments; the comments must be received in the Regional Programs Unit within 30 days following the meeting. Written comments may be mailed to the Western Regional Office, U.S. Commission on Civil Rights, 300 North Los Angeles Street, Suite 2010, Los Angeles, CA 90012. They may be faxed to the Commission at (213) 894-0508, or emailed Ana Victoria Fortes at
Records and documents discussed during the meeting will be available for public viewing prior to and after the meeting at
Commission on Civil Rights.
Announcement of 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 briefing meeting of the West Virginia Advisory Committee to the Commission will convene by conference call at 12:00 p.m. (EST) on Friday, May 4, 2018. The purpose of the meeting is hear presentations from a panel of experts who will provide a
Friday, May 4, 2018, at 12:00 p.m. (EDT).
Ivy Davis at
Public Call-In Information: Conference call-in number: 1-800-474-8920 and conference call number: 8310490.
Interested members of the public may listen to the discussion by calling the following toll-free conference call-in number: 1-800-474-8920 and conference call number: 8310490. 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 may incur charges for calls they initiate over wireless lines, and the Commission will not refund any incurred charges. Callers will incur no charges for calls they initiate over land-line connections to the toll-free conference call-in number.
Persons with hearing impairments may also follow the discussion by first calling the Federal Relay Service at 1-888-364-3109 and providing the operator with the toll-free conference call-in number: 1-800-474-8920 and conference call number: 8310490.
Members of the public are entitled to 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 Eastern Regional Office, U.S. Commission on Civil Rights, 1331 Pennsylvania Avenue, Suite 1150, Washington, DC 20425, or emailed to Corrine Sanders at
Records and documents discussed during the meeting will be available for public viewing as they become available at
Commission on Civil Rights.
Announcement of 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 planning meeting of the District of Columbia Advisory Committee to the Commission will convene at 11:30 a.m. (EDT) Tuesday, May 8, 2018 at the offices of the U.S. Commission on Civil Rights, 1331 Pennsylvania Avenue NW, Suite 1150, Washington, DC 20425. The purpose of the planning meeting is to continue project planning. This fall the Committee will conduct a briefing meeting on its civil rights project, which examines the treatment of homeless persons that get swept up in the DC criminal justice system, including a review of the DC Mental Health Court.
May 8, 2018 at 11:30 a.m. (EDT).
1331 Pennsylvania Avenue NW, Suite 1150, Washington, DC 20425.
Ivy L. Davis, at
Persons with accessibility needs should contact the Eastern Regional Office no later than 10 working days before the scheduled meeting by sending an email to the following email address at
Members of the public are entitled to submit written comments. The comments must be received in the regional office by Friday, June 8, 2018. Comments may be mailed to the Eastern Regional Office, U.S. Commission on Civil Rights, 1331 Pennsylvania Avenue Suite 1150, Washington, DC 20425 or emailed to Evelyn Bohor at
Records and documents discussed during the meeting will be available for public viewing as they become available at
Enforcement and Compliance, International Trade Administration, Department of Commerce.
Davina Friedmann or Tom Bellhouse, AD/CVD Operations, Office VI, Enforcement and Compliance, International Trade Administration, U.S. Department of Commerce, 1401 Constitution Avenue NW, Washington, DC 20230; telephone: (202) 482-0698 or (202) 482-2057, respectively.
On March 15, 2018, the Department of Commerce (Commerce) published the
This notice serves as a correction that we have not rescinded this administrative review with respect to Guangdong Xin Wei Aluminum Products Co., Ltd. Rather, we preliminarily intend to rescind the review with respect to Guangdong Xin Wei Aluminum Products Co., Ltd., because there is no evidence on the record to indicate that it had entries of subject merchandise during the period of review. As stated in the Preliminary Results, a final decision regarding whether to rescind the review of this company will be issued with the final results of review.
Enforcement and Compliance, International Trade Administration, Department of Commerce.
The Department of Commerce (Commerce) determines that Weihai Zhongwei Rubber Co., Ltd., a manufacturer/exporter of certain new pneumatic off-the-road tires (OTR tires) from the People's Republic of China (China), sold subject merchandise in the United States at prices below normal value during the period of review (POR). Additionally, we determine that Guizhou Tyre Co., Ltd. and its affiliate are ineligible for separate rate status. Finally, the new shipper review with respect to The Carlstar Group LLC, the producer Carlisle (Meizhou) Rubber Manufacturing Co., Ltd., and its affiliated exporter CTP HK has been rescinded.
Applicable: April 17, 2018.
Alex Rosen AD/CVD Operations, Office III, Enforcement and Compliance, International Trade Administration, U.S. Department of Commerce, 1401 Constitution Avenue NW, Washington, DC 20230; telephone (202) 482-7814.
On October 10, 2017, Commerce published its
In accordance with 19 CFR 351.309, we invited interested parties to comment on the
The merchandise covered by this order includes new pneumatic tires designed for off-the-road and off-highway use, subject to certain exceptions. The subject merchandise is currently classifiable under Harmonized Tariff Schedule of the United States (HTSUS) subheadings: 4011.20.10.25, 4011.20.10.35, 4011.20.50.30, 4011.20.50.50, 4011.61.00.00, 4011.62.00.00, 4011.63.00.00, 4011.69.00.00, 4011.92.00.00, 4011.93.40.00, 4011.93.80.00, 4011.94.40.00, and 4011.94.80.00. The HTSUS subheadings are provided for convenience and customs purposes only; the written product description of the scope of the order is dispositive. For a complete description of the scope of the order,
All issues raised in the case and rebuttal briefs filed by parties in this review are addressed in the Issues and Decision Memorandum, which is hereby
In accordance with 19 CFR 351.214(c), an exporter or producer may request an NSR within one year of the date on which subject merchandise was first entered, or withdrawn from warehouse, for consumption, or, if the exporter or producer cannot establish the date of the first entry, then the date on which it first shipped the merchandise for export to the United States.
As discussed in the Issues and Decision Memorandum and NSR Rescission Memorandum, Commerce finds that Carlstar's request for a new shipper review was not timely filed within one year of the date the subject merchandise produced and exported by Carlstar's predecessor was first entered into the United States, pursuant to 19 CFR 351.214(c).
In the
The statute and Commerce's regulations do not address the establishment of a rate to be assigned to respondents not selected for individual examination when Commerce limits its examination of companies subject to the administrative review pursuant to section 777A(c)(2)(B) of the Act. Generally, Commerce looks to section 735(c)(5) of the Act, which provides instructions for calculating the all-others rate in an investigation, for guidance when calculating the rate for respondents not individually examined in an administrative review. Section 735(c)(5)(A) of the Act articulates a preference for not calculating an all-others rate using rates which are zero,
Based on an analysis of the comments received, we made certain calculation changes and revisions to the valuation of certain factors of production since the
In light of changes made since the
As a result of this administrative review, we determine that the following weighted-average dumping margins exist for the period September 1, 2015, through August 31, 2016:
Additionally, as in the
We intend to disclose the calculations performed regarding these final results within five days of the date of publication of this notice to parties in this proceeding, in accordance with 19 CFR 351.224(b).
Commerce shall determine, and CBP shall assess, antidumping duties on all appropriate entries covered by this review pursuant to section 751(a)(2)(C) of the Act and 19 CFR 351.212(b)(1).
For Zhongwei, Commerce will calculate importer-specific assessment rates on the basis of the ratio of the total amount of dumping calculated for the importer's examined sales to the total entered value of sales, in accordance with 19 CFR 351.212(b)(1). For customers or importers of Zhongwei for which we do not have entered values, we calculated importer- (or customer-) specific antidumping duty assessment amounts based on the ratio of the total amount of dumping duties calculated for the examined sales of subject merchandise to the total sales quantity of those same sales.
For the non-examined separate rate companies, we will instruct CBP to liquidate all appropriate entries at 11.87 percent, which is equal to the weighted-average dumping margin assigned to Zhongwei.
For those entities that are subject to this review that Commerce has determined are part of the China-wide entity (
Because we are rescinding the new shipper review of Carlstar, we have not made a determination as to whether Carlstar qualifies for a separate rate. Therefore, Carlstar will remain part of the China-wide entity and, accordingly, any entries covered by this new shipper review will be assessed at the China-wide rate.
The following cash deposit requirements will be effective for all shipments of the subject merchandise entered, or withdrawn from warehouse, for consumption on or after the publication date of the final results of this administrative review, as provided by section 751(a)(2)(C) of the Act: (1) For the exporters listed above, the cash deposit rate will be equal to the weighted-average dumping margin identified in the “Final Results” section of this notice, above; (2) for previously investigated or reviewed Chinese and non-Chinese exporters that are not under review in this segment of the proceeding but that received a separate rate in a previous segment, the cash deposit rate will continue to be the exporter-specific rate (or exporter-producer chain rate) published for the most recently completed segment of this proceeding in which the exporter was reviewed; (3) for all Chinese exporters of subject merchandise which have not been found to be entitled to a separate rate, the cash deposit rate will be the China-wide rate of 105.31 percent; and (4) for all non-China exporters of subject merchandise which have not received their own rate, the cash deposit rate will be the rate applicable to the China exporter(s) that supplied that non-China exporter. These cash deposit requirements, when imposed, shall remain in effect until further notice.
Because we did not calculate a dumping margin for Carlstar or grant Carlstar a separate rate in this new shipper review, as noted above, we find that Carlstar continues to be part of the China-wide entity. The cash deposit rate for the China-wide entity is 105.31 percent. These cash deposit requirements shall remain in effect until further notice.
This notice serves as a final reminder to importers of their responsibility under 19 CFR 351.402(f)(2) to file a certificate regarding the reimbursement of antidumping and/or countervailing duties prior to liquidation of the relevant entries during this review period. Failure to comply with this requirement could result in the Secretary's presumption that reimbursement of the antidumping and/or countervailing duties occurred and the subsequent assessment of double antidumping duties.
This notice also serves as a reminder to parties subject to administrative protective order (APO) of their responsibility concerning the return or destruction of proprietary information disclosed under the APO in accordance with 19 CFR 351.305(a)(3), which continues to govern business proprietary information in this segment of the proceeding. Timely written notification of the return/destruction of APO materials or conversion to judicial protective order is hereby requested. Failure to comply with the regulations and terms of an APO is a violation which is subject to sanction.
We are issuing and publishing these final results of administrative review in accordance with sections 751(a)(1) and 777(i) of the Act.
Enforcement and Compliance, International Trade Administration, Department of Commerce.
The Department of Commerce (Commerce) finds that Deacero S.A.P.I. de C.V. (Deacero), a producer and exporter of carbon and certain alloy steel wire rod (wire rod) from Mexico, made sales of subject merchandise at less than normal value (NV) during the period of review (POR), October 1, 2015, through September 30, 2016. We also find that ArcelorMittal las Truchas, S.A. de C.V. (AMLT) made no shipments of subject merchandise during the POR.
Applicable April 17, 2018.
Keith Haynes, AD/CVD Operations, Office III, Enforcement and Compliance, International Trade Administration, U.S. Department of Commerce, 1401 Constitution Avenue NW, Washington, DC 20230; telephone: (202) 482-5139.
Commerce published the preliminary results of this administrative review of wire rod from Mexico on November 8, 2017.
Commerce has exercised its discretion to toll all deadlines affected by the duration of the closure of the Federal Government from January 20 through 22, 2018.
Based on an analysis of the comments received, Commerce has made changes to the calculated weighted-average dumping margin determined for Deacero. Commerce has listed the final calculated weighted-average dumping margin in the “Final Results of Administrative Review” section below.
The product covered by the order is wire rod, in coils, of approximately round cross section, 5.00 mm or more, but less than 19.00 mm, in solid cross-sectional diameter.
Commerce has addressed the issues raised by Deacero and Nucor in their case and rebuttal briefs in the Issues and Decision Memorandum. Commerce has identified and listed these issues in the Appendix to this notice. Because the Issues and Decision Memorandum is a public document, parties can find a complete discussion of these issues and the corresponding recommendations filed electronically via Enforcement and Compliance's Antidumping and Countervailing Duty Centralized Electronic Service System (ACCESS). ACCESS is available to registered users at
Based on the case brief and rebuttal comments received from Deacero and Nucor, we made changes to our rate calculation for Deacero. For a discussion of these issues,
In the
Commerce finds that the following estimated weighted-average dumping margin exists during the POR, as referenced below:
In accordance with 19 CFR 351.212(b)(1), Commerce intends to issue appropriate instructions to CBP 41 days after publication of the final results of this review.
For Deacero, because its weighted-average dumping margin is not zero or
As noted in the “Final Determination of No Shipments” section, above, Commerce will instruct CBP to liquidate any existing entries of merchandise produced by AMLT but exported by other parties, at the rate for the intermediate reseller, if available, or at the all-others rate.
The following cash deposit requirements will be effective upon publication of the notice of final results of administrative review for all shipments of subject merchandise entered, or withdrawn from warehouse, for consumption on or after the publication of the final results of this administrative review, as provided by section 751(a)(2) of the Act: (1) The cash deposit rate for Deacero will be the rate established in the final results of this administrative review; (2) for merchandise exported by producers or exporters not covered in this administrative review but covered in a prior segment of the proceeding, the cash deposit rate will continue to be the company-specific rate published for the most recent period; (3) if the exporter is not a firm covered in this review, a prior review, or the original investigation, but the producer is, the cash deposit rate will be the rate established for the most recent period for the producer of the merchandise; and (4) the cash deposit rate for all other producer or exporters will continue to be 20.11 percent, the all-others rate established in the investigation.
This notice also serves as a final reminder to importers of their responsibility under 19 CFR 351.402(f)(2) to file a certificate regarding the reimbursement of antidumping duties prior to liquidation of the relevant entries during this POR. Failure to comply with this requirement could result in Commerce's presumption that reimbursement of antidumping duties has occurred and the subsequent assessment of doubled antidumping duties.
This notice also serves as a final reminder to parties subject to an administrative protective order (APO) of their responsibility concerning the return or destruction of proprietary information disclosed under APO in accordance with 19 CFR 351.305(a)(3), which continues to govern business proprietary information in this segment of proceeding. Timely written notification of the return/destruction of APO materials or conversion to judicial protective order is hereby requested. Failure to comply with the regulations and terms of an APO is a violation which is subject to sanction.
These final results are issued and published in accordance with sections 751(a)(1) and 777(i)(1) of the Act.
The United States Patent and Trademark Office (USPTO) will submit to the Office of Management and Budget (OMB) for clearance the following proposals for collection of information under the provisions of the Paperwork Reduction Act (44 U.S.C. Chapter 35).
This information collection covers the Certificate Action Form (PTO-2042), which is used by the public to request a new digital certificate, revoke a current certificate, or recover a lost or corrupted certificate. Customers may also change the name listed on the certificate or associate the certificate with one or more Customer Numbers. A Customer Number allows an applicant to associate all correspondence and USPTO actions regarding multiple patent applications to a single address and name. The Certificate Action Form must include a notarized signature in order to verify the identity of the application. The Certificate Action Form has an accompanying subscriber agreement to ensure that customers understand their obligations regarding the use of the digital certificates and cryptographic software. When generating a new certificate, customers also register to receive a set of seven codes that will enable customers to recover a lost certificate online without having to contact USPTO support staff.
Further information can be obtained by:
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Written comments and recommendations for the proposed information collection should be sent on or before May 17, 2018 to Nicholas A. Fraser, OMB Desk Officer, via email to
The United States Patent and Trademark Office (USPTO) will submit to the Office of Management and Budget (OMB) for clearance the following proposal for collection of information under the Paperwork Reduction Act (44 U.S.C. Chapter 35).
This collection covers information that individuals submit in applications to establish a USPTO online access account. This application allows users to obtain, renew, or replace online access account cards which provide access to the electronic search system at the Public Search Facility. The public may apply for an online access account only at the Public Search Facility reference desk by providing the completed application (including contact information) and proper identification. The access account cards include a bar-coded user number and an expiration date. Users may renew their account card in person by validating and updating the required information and may obtain a replacement for a lost account card by providing proper identification. Users who wish to register for the voluntary training courses may do so by completing the appropriate form.
This collection also covers information in applications to establish, renew, or replace security identification badges issued under the authority provided in 41 CFR part 102-81 to members of the public who wish to access the Public Search Facility. Users may apply for a security badge in person at the USPTO Security Office by providing the completed application (including applicant and contact information) and presenting a valid form of identification with photograph. The security badges include a color photograph of the user and must be worn always while at the USPTO facilities.
Further information can be obtained by:
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Written comments and recommendations for the proposed information collection should be sent on or before May 17, 2018 to Nicholas A. Fraser. OMB Desk Officer, via email to
Proposed collection; comment request.
The United States Patent and Trademark Office (USPTO), as required by the Paperwork Reduction Act of 1995, invites comments on a proposed extension of an existing information collection: 0651-0061 (Trademark Petitions).
Written comments must be submitted on or before June 18, 2018.
You may submit comments by any of the following methods:
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Requests for additional information should be directed to Catherine Cain, Attorney Advisor, Office of the Commissioner for Trademarks, United States Patent and Trademark Office, P.O. Box 1450, Alexandria, VA 22313-1450; by telephone at 571-272-8946; or by email to
The United States Patent and Trademark Office (USPTO) administers the Trademark Act, 15 U.S.C. 1051
Individuals and businesses may also submit various communications to the USPTO, including letters of protest, requests to make special, responses to petition inquiry letters, petitions to make special, requests to restore a filing date, and requests for reinstatement. The USPTO uses the information described in this collection to process letters of protests, requests to make special, responses to petition inquiry letters, petitions to make special, requests to restore filing date, and requests for reinstatement. The information is used by the public for a variety of private business purposes related to establishing and enforcing trademark rights. Information relating to the registration of a trademark is made available to the public by the USPTO. However, the release of information in a letter of protest is controlled and may be available only upon request.
A letter of protest is an informal procedure whereby third parties who object to the registration of a mark in a pending application may bring to the attention of the USPTO evidence bearing on the registrability of the mark. A letter of protest must identify the application being protested and the proposed grounds for refusing registration and include relevant evidence to support the protest.
A request to make special may be submitted where an applicant requests that initial examination of an application be advanced out of its regular order because the mark in the application was the subject of an inadvertently cancelled or expired previous registration.
A response to a petition inquiry letter is submitted by a petitioner who is responding to a notice of deficiency that the USPTO issued after receiving an incomplete petition to the Director. A petition may be considered incomplete if, for example, it does not include the fee required by 37 CFR 2.6 or if it includes an unverified assertion that is not supported by evidence.
The USPTO generally examines applications in the order in which they are received. A petition to make special is a request by the applicant to advance the initial examination of an application out of its regular order.
A request to restore a filing date is submitted by an applicant who previously filed an application that was denied a filing date. The request must include evidence showing that the applicant is entitled to the earlier filing date.
If an applicant has proof that an application was inadvertently abandoned due to a USPTO error, an applicant may file a request to reinstate the application instead of a formal petition to revive. To support such a request, the applicant must include clear evidence of the USPTO error.
Electronically, if applicants submit the information using the forms available through the Trademark Electronic Application System (TEAS). By mail or hand delivery, if applicants choose to submit the information in paper form.
There are fees associated with this collection, specifically for the Petition to Make Special, which has a fee amount of $100 per respondent. The total estimated filing-fee cost for this collection is $53,300.00
Applicants incur postage costs when submitting non-electronic information to the USPTO by mail through the United States Postal Service (USPS). The USPTO estimates that the vast majority—approximately 98%—of the paper forms are submitted to the USPTO via first-class mail, while the rest are submitted by hand delivery. The USPTO estimates that 16 forms will be mailed. The average first-class USPS postage cost for a mailed submission is $0.50. Therefore, the USPTO estimates that the postage costs for the mailed submissions in this collection will total $8.
Therefore, the USPTO estimates that the total annual (non-hour) cost burden for this collection, in the form of filing fees ($53,300) and postage costs ($8), is $53,308 per year.
Comments submitted in response to this notice will be summarized or included in the request for OMB approval of this information collection. They also will become a matter of public record.
Comments are invited on:
(a) Whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility;
(b) The accuracy of the agency's estimate of the burden (including hours and cost) of the proposed collection of information;
(c) Ways to enhance the quality, utility, and clarity of the information to be collected; and
(d) Ways to minimize the burden of the collection of information on respondents,
Proposed collection; comment request.
The United States Patent and Trademark Office (USPTO), as required by the Paperwork Reduction Act of 1995, invites comments on a proposed extension of an existing information collection: 0651-0062 (Third-Party Submissions and Protests).
Written comments must be submitted on or before June 18, 2018.
You may submit comments by any of the following methods:
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Requests for additional information should be directed to Raul Tamayo, Senior Legal Advisor, Office of Patent Legal Administration, United States Patent and Trademark Office, P.O. Box 1450, Alexandria, VA 22313-1450; by telephone at 571-272-7728; or by email to
The United States Patent and Trademark Office (USPTO) is required by 35 U.S.C. 131
37 CFR 1.290 provides a mechanism for third parties to submit to the USPTO, for consideration and inclusion in the record of a patent application, any patents, published patent applications, or other printed publications of potential relevance to the examination of the application.
A third-party submission under 37 CFR 1.290 may be made in any non-provisional utility, design, and plant application, as well as in any continuing application. A third-party submission under 37 CFR 1.290 must include a concise description of the asserted relevance of each document submitted, and must be submitted within a certain statutorily specified time period.
37 CFR 1.291 permits a member of the public to file a protest against a pending application. Protests pursuant to 37 CFR 1.291 are supported by a separated statutory provision from third-party submissions under 37 CFR 1.290 (35 U.S.C. 122(c) v. 35 U.S.C. 122(e)). As a result, there are several differences between protests and third-party submissions.
For example, 37 CFR 1.291 permits the submission of information in a protest that is not permitted in a third-party submission under 37 CFR 1.290. Specifically, 37 CFR 1.291 provides for the submission of information, including any facts or information adverse to patentability. Further, 37 CFR 1.291 requires a protest to include a concise explanation of the relevance of each item of information submitted. Unlike the concise description of relevance required for a third-party submission under 37 CFR 1.290, which is limited to a description of a document's relevance, the concise explanation for a protest under 37 CFR 1.291 allows for arguments against patentability. Additionally, the specified time period for submitting a protest differs from the time period for submitting third-party submissions, and is impacted by whether the protest is accompanied by the written consent of the applicant.
This information collection is necessary so that the public may contribute to the quality of issued patents. The USPTO will use this information, as appropriate, to assist in evaluating the patent application as it moves through the patent examination process.
The USPTO provides an exemption from the 1.17(o) fee requirement where a third-party submission listing three or fewer total documents is the first third-party submission submitted in an application by the third party, or a party in privity with the third party. The effect of this is that the first three documents submitted by a third party are exempt from the fee requirement. However, the submission of four or more documents by a third party triggers the collection of the fee.
There is no fee for filing protests under 37 CFR 1.291 unless the filed protest is the second or subsequent protest by the same real party in interest, in which case the 37 CFR 1.17(i) fee of $130 must be included. The USPTO estimates that only 1 out of every 10 protests filed per year will require this fee.
When electronically submitting the information in this collection to the USPTO, the applicant is encouraged to retain a copy of the file submitted to the USPTO as evidence of the application. Inclusion of an USPS acknowledgement receipt with mailed items provides evidence of the date the file was received by the USPTO. The USPTO does not, however, require this recordkeeping, and thus does not consider this action to be a recordkeeping cost imposed on the applicant.
This collection also has non-hourly annual cost burden in the form of postage costs. Customers may incur postage costs when submitting the instruments contained within this collection to the USPTO by mail through the United States Postal Service. The USPTO estimates that the average first class postage cost for a one-pound submission mailed in a flat-rate envelope to be $6.70. The USPTO estimates that the vast majority—roughly 98 percent—of all paper submissions will be delivered by mail, with the remainder being delivered by hand delivery, for an estimated that approximately 40 submissions will require postage. Therefore, the estimated postage cost for this collection will be $268.
The total non-hour respondent cost burden for this collection in the form of filing fees ($73,930) and postage costs ($268) is approximately $74,198.
Comments submitted in response to this notice will be summarized or included in the request for OMB approval of this information collection. They will also become a matter of public record.
Comments are invited on:
(a) Whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility;
(b) The accuracy of the agency's estimate of the burden (including hours and cost) of the proposed collection of information;
(c) Ways to enhance the quality, utility, and clarity of the information to be collected; and
(d) Ways to minimize the burden of the collection of information on respondents,
Bureau of Consumer Financial Protection.
Notice and request for information.
The Bureau of Consumer Financial Protection (Bureau) is seeking comments and information from interested parties to assist the Bureau in assessing its handling of consumer complaints and consumer inquiries and, consistent with law, considering whether changes to its processes would be appropriate.
Comments must be received by July 16, 2018.
You may submit responsive information and other comments, identified by Docket No. CFPB-2018-0014, by any of the following methods:
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All submissions in response to this request for information, including attachments and other supporting materials, will become part of the public record and subject to public disclosure. Proprietary information or sensitive personal information, such as account numbers or Social Security numbers, or names of other individuals, should not be included. Submissions will not be edited to remove any identifying or contact information.
Darian Dorsey, Deputy Assistant Director, Office of Consumer Response, at 202-435-7268. If you require this document in an alternative electronic format, please contact
An important aspect of the Bureau's mission is hearing directly from the American public about their experiences in the consumer financial marketplace. Pursuant to 12 U.S.C. 5511(c)(2), “collecting, investigating, and responding to consumer complaints” is one of the six statutory “primary functions” of the Bureau. In addition, ensuring that “consumers are provided with timely and understandable information to make responsible decisions about financial transactions” is one of its six enumerated objectives.
In furtherance of these statutory mandates, the Dodd-Frank Wall Street Reform and Consumer Protection Act (Dodd-Frank Act) requires the Bureau to establish a unit to “facilitate the centralized collection of, monitoring of, and response to consumer complaints regarding consumer financial products or services”
Since it began accepting consumer complaints and consumer inquiries in July 2011, the Bureau has established reasonable procedures to provide consumers with timely responses to their complaints and inquiries, in writing where appropriate.
Though the Bureau is required to establish reasonable procedures to provide timely responses to consumer complaints and consumer inquiries, certain aspects of the complaint and inquiry handling processes were developed in furtherance of those statutory requirements but are not directly mandated by statute. Mindful of the Bureau's statutory objective to provide consumers with timely and understandable information about consumer financial products and services so they can make responsible decisions, as well as its statutory obligations to (1) establish reasonable procedures to provide consumers with timely responses and (2) centralize the collection of consumer complaints about consumer financial products or
The Bureau is using this request for information (RFI) to seek public input regarding potential changes that can be implemented to the Bureau's consumer complaint and inquiry handling processes, consistent with law, to consider whether any changes to existing practices would be appropriate given the Bureau's statutory objective to provide consumers with timely and understandable information about consumer financial products and services to make responsible decisions as well as its statutory obligations to (1) establish reasonable procedures to provide timely responses to consumers and (2) centralize the collection of consumer complaints regarding consumer financial products or services. The Bureau encourages comments from all interested members of the public, including financial industry participants, government agencies, academic and research organizations, consumer advocacy and financial education groups, trade associations, and consumers.
The Bureau previously issued an RFI seeking public input regarding potential changes that can be implemented to the Bureau's public reporting practices of consumer complaint information, consistent with law, to consider whether any changes to the practices would be appropriate.
To allow the Bureau to evaluate suggestions more effectively, the Bureau requests that, where possible, comments include:
• Specific discussion of the positive and negative aspects of the Bureau's complaint and inquiry processes;
• Specific suggestions regarding any potential updates or modifications to the Bureau's complaint and inquiry processes, consistent with the law and given one of the Bureau's statutory obligations is to establish reasonable procedures to provide consumers with timely responses to complaints and inquiries, including, in as much detail as possible, the nature of the modification, and supporting data or other information on impacts and costs;
• Specific best practices for complaint and inquiry processes given the Bureau's statutory objectives and functions, including ensuring consumers are provided with timely and understandable information to make responsible decisions about financial transactions
The following represents a preliminary attempt by the Bureau to identify elements of the Bureau's complaint and inquiry processes on which commenters may want to comment. This non-exhaustive list is meant to assist in the formulation of comments and is not intended to restrict the issues that may be addressed. In addressing these issues and questions, the Bureau requests that commenters identify with specificity the complaint or inquiry processes feature at issue, providing legal citations where appropriate and available.
The Bureau is seeking feedback on all aspects of its consumer complaint and inquiry handling processes, including:
1. Specific statutorily-permissible suggestions regarding how the Bureau currently allows consumers to submit complaints and inquiries, including:
a. Should the Bureau require consumers to classify their submission affirmatively as a consumer complaint or inquiry prior to submission?
b. How should the Bureau explain the difference between a consumer complaint and a consumer inquiry to consumers at the point of submission?
c. Should the Bureau develop a process for companies to reclassify consumers' submissions? If so, what criteria should the Bureau establish to help companies differentiate consumer complaints from consumer inquiries?
2. Specific statutorily-permissible suggestions regarding the Bureau's consumer complaint processes, including:
a. The Bureau currently receives complaints via six channels: Website, referral from Federal and State entities/agencies, telephone, mail, fax, and email. Should the Bureau add or discontinue any channels for accepting complaints?
b. Consistent with the Dodd-Frank Act's definition of “consumer,” the Bureau currently allows consumers to authorize someone else (
3. Specific statutorily-permissible suggestions regarding the Bureau's consumer inquiry processes, including:
a. The Bureau currently accepts consumer inquiries via telephone and mail. Should the Bureau add or discontinue any channels for accepting inquiries?
b. Should the Bureau develop web chat systems to support consumers' submission of inquiries?
c. Should the Bureau develop a process for companies to provide timely responses to consumer inquiries sent to them by the Bureau? If so, how should the Bureau balance its objective of providing timely and understandable information to consumers
d. Should the Bureau publish data about consumer inquiries? If so, what types of data or analyses about consumer inquiries should be shared with the public?
12 U.S.C. 5511(c).
Joint Rules of Appellate Procedure for Courts of Criminal Appeals (JRAP) Committee, Department of Defense.
Notice of availability of proposed changes to the Joint Rules of Appellate Procedure for Courts of Criminal Appeals.
This notice announces proposed changes to the Joint Rules of Appellate Procedure for Courts of Criminal Appeals (JRAP), which prescribe uniform procedures for the service Courts of Criminal Appeals. Although these rules of practice and procedure fall within the Administrative Procedure Act's exemptions for notice and comment, the Department, as a matter of policy, has decided to make these changes available for public review and comment before they are implemented. The proposed changes implement the Military Justice Act of 2016 of the National Defense Authorization Act of 2017 and the 2018 Amendments to the Manual for Courts-Martial, United States. The approval authorities for these changes are the Judge Advocates General of the Army, Navy, Air Force, and Coast Guard.
Comments on the proposed changes must be received no later than May 17, 2018.
You may submit comments, identified by docket number and title by any of the following methods:
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Lieutenant Commander Rachel Trest, JAGC, USN, United States Navy-Marine Corps Court of Criminal Appeals, (202) 685-4621,
As the proposed revisions to the JRAP are substantial, the full text of the proposed new JRAP is available electronically at
The JRAP Committee invites members of the public to comment on the proposed new rules; such comments should address specific recommended changes and provide supporting rationale.
This notice is intended only to improve the internal management of the Federal Government. It is not intended to create any right or benefit, substantive or procedural, enforceable at law by any party against the United States, its agencies, its officers, or any person.
Federal Student Aid (FSA), Department of Education (ED).
Notice.
In accordance with the Paperwork Reduction Act of 1995, ED is proposing a revision of an existing information collection.
Interested persons are invited to submit comments on or before May 17, 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 Jon Utz, 202-377-4040.
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 necessary to the proper functions of the Department; (2) will this information be processed and used in a timely manner; (3) is the estimate of burden accurate; (4) how might the Department enhance the quality, utility, and clarity of the information to be collected; and (5) how might the Department minimize the burden of this collection on the respondents, including through the use of information technology. Please note that written comments received in response to this notice will be considered public records.
Office of Environmental Management, Department of Energy.
Notice of Renewal.
Pursuant to the Federal Advisory Committee Act, and following consultation with the Committee Management Secretariat, General Services Administration, notice is hereby given that the Environmental Management Site-Specific Advisory Board (EM SSAB or Board) will be renewed for a two-year period beginning on April 11, 2018.
The Board provides the Assistant Secretary for Environmental Management (EM) with advice and recommendations concerning issues affecting the EM program at various sites. These site-specific issues include clean-up standards and environmental restoration; waste management and disposition; stabilization and disposition of non-stockpile nuclear materials; excess facilities; future land use and long-term stewardship; risk assessment and management; and clean-up science and technology activities.
Additionally, the renewal of the Board has been determined to be essential to conduct DOE's business and to be in the public interest in connection with the performance of duties imposed on the DOE by law and agreement. The Board will operate in accordance with the provisions of the Federal Advisory Committee Act, and rules and regulations issued in implementation of that Act.
Mr. David Borak, Designated Federal Officer, at (202) 586-9928 or
U.S. Department of Energy.
Notice and request for comments.
The Department of Energy (DOE), pursuant to the Paperwork Reduction Act of 1995, intends to extend for three years, an information collection request with the Office of Management and Budget (OMB). Comments are invited on: (a) Whether the extended collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility; (b) the accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (c) ways to enhance the quality, utility, and clarity of the information to be collected; and (d) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or other forms of information technology.
Comments regarding this proposed information collection must be received on or before June 18, 2018. If you anticipate difficulty in submitting comments within that period, contact the person listed in the
Written comments may be sent to Alesia Gant, U.S. Department of Energy, 1000 Independence Avenue SW, Washington, DC 20585-1615, or by email at
Alesia Gant at the address listed in
This information collection request contains: (1) OMB No. 1910-0600; (2) Information Collection Request Titled: Industrial Relations; (3) Type of Review: Renewal; (4) Purpose: This information is required for management oversight of the Department of Energy's Facilities Management Contractors and to ensure that the programmatic and administrative management requirements of the contract are managed efficiently and effectively; (5) Annual Estimated Number of Respondents: 42; (6) Annual Estimated Number of Total Responses: 316; (7) Annual Estimated Number of Burden Hours: 4,093; (8) Annual Estimated Reporting and Recordkeeping Cost Burden: $0.
42 U.S.C. 7256; 48 CFR 970.0370-1.
Department of Energy (DOE).
Notice of open meeting.
This notice announces a meeting of the Environmental Management Site-Specific Advisory Board (EM SSAB) Chairs. The Federal Advisory Committee Act requires that public notice of this meeting be announced in the
Thursday, May 3, 2018, 8:00 a.m.-5:00 p.m.
Holiday Inn Roswell, 3620 North Main Street, Roswell, New Mexico 88201.
David Borak, EM SSAB Designated Federal Officer, U.S. Department of Energy, 1000 Independence Avenue SW, Washington, DC 20585; Phone: (202) 586-9928.
Office of Fossil Energy, DOE.
Notice of application.
The Office of Fossil Energy (FE) of the Department of Energy (DOE) gives notice of receipt of an application (Application), filed on March 23, 2018, by Sabine Pass Liquefaction, LLC (SPL), requesting blanket authorization to export liquefied natural gas (LNG) previously imported into the United States from foreign sources in an amount up to the equivalent of 500 billion cubic feet (Bcf) of natural gas on a short-term or spot market basis for a two-year period commencing on June 7, 2018. SPL states that the existing blanket re-export authorization of its affiliate, Cheniere Marketing, LLC, set forth in DOE/FE Order No. 3825 (May 26, 2016) is scheduled to expire on June 6, 2018. SPL seeks authorization to export the LNG from the Sabine Pass LNG Terminal owned by Sabine Pass LNG, L.P. and located in Cameron Parish, Louisiana, to any country with the capacity to import LNG via ocean-going carrier and with which trade is not prohibited by U.S. law or policy. SPL states that it does not seek authorization to export any domestically produced natural gas or LNG. SPL is requesting this authorization on its own behalf and as agent for other parties who hold title to the LNG at the time of export. The Application was filed under section 3 of the Natural Gas Act (NGA). Additional details can be found in SPL's Application, posted on the DOE/FE website at:
Protests, motions to intervene or notices of intervention, as applicable, requests for additional procedures, and written comments are to be filed using procedures detailed in the Public Comment Procedures section no later than 4:30 p.m., Eastern time, May 17, 2018.
The Application will be reviewed pursuant to section 3 of the NGA, 15 U.S.C. 717b. In reviewing this Application, DOE will consider domestic need for the gas, as well as any other issues determined to be appropriate, including whether the arrangement is consistent with DOE's policy of promoting competition in the marketplace by allowing commercial parties to freely negotiate their own trade arrangements. Parties that may oppose this application should comment in their responses on these issues.
The National Environmental Policy Act (NEPA), 42 U.S.C. 4321
In response to this Notice, any person may file a protest, comments, or a motion to intervene or notice of intervention, as applicable. Interested parties will be provided 30 days from the date of publication of this Notice in which to submit comments, protests, motions to intervene, or notices of intervention.
Any person wishing to become a party to the proceeding must file a motion to intervene or notice of intervention. The filing of comments or a protest with respect to the Application will not serve to make the commenter or protestant a party to the proceeding, although protests and comments received from persons who are not parties will be considered in determining the appropriate action to be taken on the Application. All protests, comments, motions to intervene, or notices of intervention must meet the requirements specified by the regulations in 10 CFR part 590.
Filings may be submitted using one of the following methods: (1) Emailing the filing to
A decisional record on the Application will be developed through responses to this notice by parties, including the parties' written comments and replies thereto. Additional procedures will be used as necessary to achieve a complete understanding of the facts and issues. If an additional procedure is scheduled, notice will be provided to all parties. If no party requests additional procedures, a final Opinion and Order may be issued based on the official record, including the Application and responses filed by parties pursuant to this notice, in accordance with 10 CFR 590.316.
The Application is available for inspection and copying in the Office of Regulation and International Engagement docket room, Room 3E-042, 1000 Independence Avenue SW, Washington, DC 20585. The docket room is open between the hours of 8:00 a.m. and 4:30 p.m., Monday through Friday, except Federal holidays. The Application and any filed protests, motions to intervene or notice of interventions, and comments will also be available electronically by going to the following DOE/FE Web address:
The Federal Energy Regulatory Commission (Commission) hereby gives notice that members of the Commission may attend the following hearing:
The House Committee on Energy and Commerce will be holding a general oversight hearing entitled “Oversight of the Federal Energy Regulatory Commission and the FY2019 Budget.” All five Commission members may testify at the hearing.
Further information regarding this hearing may be found at:
The discussions at the hearing, which are open to the public, may address issues relevant to Commission proceedings.
For further information, please contact Jehmal Hudson, 202-502-6142, or
As announced in the Notice of Technical Conference issued on March 23, 2018, the Federal Energy Regulatory Commission staff will hold a technical conference on May 1, 2018, at the Commission's headquarters at 888 First Street NE, Washington, DC 20426, between 9:00 a.m. and 4:00 p.m. (Eastern Time). The purpose of the technical conference is to explore the processes used by participating transmission owners (PTOs) in the California Independent System Operator Corporation (CAISO) to determine which transmission-related maintenance and compliance activities/facilities, including, but not limited to, transmission-related capital additions, are subject to the CAISO Transmission Planning Process (TPP).
In Order No. 890, the Commission required all public utility transmission providers, including regional transmission organizations (RTOs) and independent system operators (ISOs), to revise their open access transmission tariffs (OATTs) to incorporate a transmission planning process that satisfied nine transmission planning principles to limit the opportunities for undue discrimination and anticompetitive conduct in transmission service.
In a series of orders issued between 2008 and 2010, the Commission accepted CAISO's TPP as consistent with the requirements of Order No. 890.
In an order issued March 23, 2018 in Docket No. ER18-370-000,
Given the background provided herein, participants should be prepared to discuss the following:
1. Please define and describe what constitutes transmission-related maintenance and compliance activities/facilities. Please provide specific examples and an explanation regarding how it is determined that such an example falls into the category of transmission-related maintenance and compliance activities/facilities. How does each CAISO PTO identify the need for transmission-related maintenance and compliance activities/facilities and decide which activities/facilities to undertake?
2. How does each CASIO PTO determine if actions taken to maintain, repair, or replace facilities should be considered and reviewed through CAISO's TPP? Which transmission-related maintenance and compliance activities/facilities are submitted for consideration and review through CAISO's TPP and which activities or transmission facilities are considered and reviewed solely by PTOs? Please explain.
3. Are there criteria or parameters that each CAISO PTO uses to determine which transmission-related maintenance and compliance activities/facilities to submit to CAISO for consideration and review through CAISO's TPP? What factors are considered (
4. Do CAISO's tariff or BPMs provide guidance and clarity to CAISO PTOs regarding what transmission-related maintenance and compliance activities/facilities must be considered and reviewed through CAISO's TPP? If so, please list the relevant sections.
5. For transmission-related maintenance and compliance activities/facilities that may enhance the transmission system (such as additions that increase line ratings or extend the useful life of a transmission asset), how does each CAISO PTO determine whether this maintenance or compliance activity/facility should be considered and reviewed as part of CAISO's TPP? Where are the criteria or parameters related to this determination documented or otherwise made available?
6. When deciding whether to submit a transmission-related maintenance and compliance activity/facility for consideration and review through CAISO's TPP, does each CAISO PTO differentiate between transmission-related maintenance and compliance activities/facilities that require immediate action (
7. Is there a process through which each CAISO PTO evaluates whether a transmission-related maintenance and compliance activity/facility that was not initially submitted to CAISO's TPP should be transitioned into the CAISO TPP for consideration and review? If so, please describe that process, including what criteria or parameters are considered in reaching the conclusion to transition to CAISO's TPP. Also, please explain where such criteria or parameters are documented or otherwise made available.
8. What information does each CAISO PTO submit to CAISO (during Phase I of the TPP) concerning the transmission-related maintenance and compliance activities/facilities planned outside of CAISO's TPP? Please explain what type of information is provided and what level of detail is included.
9. What is the process through which each CAISO PTO performs transmission planning activities outside of CAISO's TPP? Please describe that process in detail.
10. Are there processes for stakeholders to review and provide input on transmission-related maintenance and compliance activities/facilities, including transmission-related capital additions, not included in CAISO's TPP? If so, please describe these processes in detail, including whether there is an opportunity for stakeholders to review and provide input on cost and other factors. Please also describe the timeframe for providing this input.
11. How does each CAISO PTO decide whether to pursue reliability-related transmission-related maintenance and compliance activities/facilities that are not required by the North American Electric Reliability Corporation (NERC), Western Electricity Coordinating Council (WECC), or other regulatory entities? What criteria or parameters are used by each CAISO PTO to make this decision? Where are such criteria or parameters documented or otherwise made available?
12. Is there a difference between (a) the process through which each CAISO PTO pursues solutions to transmission-related maintenance and compliance activities/facilities that arise from NERC and WECC reliability standards or reliability standards established by other regulatory entities, and (b) the process through which each CAISO PTO pursues solutions to other transmission-related maintenance and compliance activities/facilities? If so, please explain (1) the difference between the two processes and (2) elaborate on the reasons for the differences.
13. Please explain how costs associated with transmission-related maintenance and compliance activities/facilities developed outside of the CAISO TPP are reflected in wholesale and retail transmission rates.
14. How does each CAISO PTO determine whether transmission-related maintenance, repair, or replacement activities/facilities should be capitalized or expensed as operations and maintenance costs? Please explain.
15. What recommendations do you have for each CAISO PTO to increase the transparency of the process for stakeholders and others with respect to the CAISO PTOs' planning for transmission-related maintenance and compliance activities/facilities? How would these recommendations affect the CAISO PTOs? Would such effects be manageable? If not, why not? If changes to increase transparency could be made, should they be the same for each CAISO PTO?
The technical conference will be led by Commission staff, and is open to the public. All interested persons may attend the conference, and registration is not required. However, in-person attendees are encouraged to register on-line by April 20, 2018 at
The conference will consist of questions posed by Commission staff and responses provided by CAISO, the CAISO PTOs, and complainants. There may also be an opportunity for follow-up questions and comments from attendees during those discussions. The specific agenda and procedures to be followed at the conference will be announced by staff at the opening of the conference.
The technical conference will be transcribed, and the transcript will be available immediately for a fee from Ace Reporting Company ((202) 347-3700).
Commission conferences are accessible under section 508 of the Rehabilitation Act of 1973. For accessibility accommodations, please send an email to
Following the technical conference, all interested persons are invited to file initial and reply post-technical conference comments on the topics discussed during the technical conference, including the questions listed above. Commenters may reference material previously filed in this docket, including the technical conference transcript, but are encouraged to avoid repetition or replication of previous material. Initial comments are due on or before May 31, 2018; reply comments are due on or before June 15, 2018. Initial comments should not exceed 15 pages, and reply comments should not exceed 10 pages. The written comments will be included in the formal record of the proceeding, which, together with the record developed to date, will form the basis for further Commission action.
For Further Information, Please Contact Individuals Identified for Each Topic:
Take notice that the Commission has received the following Natural Gas Pipeline Rate and Refund Report filings:
The filings are accessible in the Commission's eLibrary system by clicking on the links or querying the docket number.
Any person desiring to intervene or protest in any of the above proceedings must file in accordance with Rules 211 and 214 of the Commission's Regulations (18 CFR 385.211 and 385.214) on or before 5:00 p.m. Eastern time on the specified comment date. Protests may be considered, but intervention is necessary to become a party to the proceeding.
eFiling is encouraged. More detailed information relating to filing requirements, interventions, protests, service, and qualifying facilities filings can be found at:
Take notice that on April 6, 2018, pursuant to Rule 207(a)(2) of the Federal Energy Regulatory Commission's (Commission) Rules of Practice and Procedure, 18 CFR 385.207(a)(2) (2017), Marathon Pipe Line LLC and MPLX Ozark Pipe Line LLC filed a joint petition for a declaratory order seeking approval of certain terms and conditions in the transportation services agreement, related to a joint expansion project, all as more fully explained in the petition.
Any person desiring to intervene or to protest this filing must file in accordance with Rules 211 and 214 of the Commission's Rules of Practice and Procedure (18 CFR 385.211, 385.214). Protests will be considered by the Commission in determining the appropriate action to be taken, but will not serve to make protestants parties to the proceeding. Any person wishing to become a party must file a notice of intervention or motion to intervene, as appropriate. Such notices, motions, or protests must be filed on or before the comment date. Anyone filing a motion to intervene or protest must serve a copy of that document on the Petitioner.
The Commission encourages electronic submission of protests and interventions in lieu of paper using the “eFiling” link at
This filing is accessible on-line at
The staff of the Federal Energy Regulatory Commission (FERC or Commission) will prepare an environmental assessment (EA) that will discuss the environmental impacts of the Empire North Project involving construction and operation of facilities by Empire Pipeline, Inc. (Empire) in Tioga County, Pennsylvania and in Ontario, Yates, Schuyler, Chemung, and Steuben Counties, New York. The Commission will use this EA in its decision-making process to determine whether the project is in the public convenience and necessity.
This notice announces the opening of the scoping process the Commission will use to gather input from the public and interested agencies on the project. You can make a difference by providing us with your specific comments or concerns about the project. Your comments should focus on the potential environmental effects, reasonable alternatives, and measures to avoid or lessen environmental impacts. Your input will help the Commission staff
If you sent comments on this project to the Commission before the opening of this docket on February 16, 2018, you will need to file those comments in Docket No. CP18-89-000 to ensure they are considered as part of this proceeding.
This notice is being sent to the Commission's current environmental mailing list for this project. State and local government representatives should notify their constituents of this proposed project and encourage them to comment on their areas of concern.
If you are a landowner receiving this notice, a pipeline company representative may contact you about the acquisition of an easement to construct, operate, and maintain the proposed facilities. The company would seek to negotiate a mutually acceptable agreement. However, if the Commission approves the project, that approval conveys with it the right of eminent domain. Therefore, if easement negotiations fail to produce an agreement, the pipeline company could initiate condemnation proceedings where compensation would be determined in accordance with state law.
Empire provided landowners with a fact sheet prepared by the FERC entitled “An Interstate Natural Gas Facility On My Land? What Do I Need To Know?” This fact sheet addresses a number of typically asked questions, including the use of eminent domain and how to participate in the Commission's proceedings. It is also available for viewing on the FERC website (
For your convenience, there are three methods you can use to submit your comments to the Commission. The Commission encourages electronic filing of comments and has expert staff available to assist you at (202) 502-8258 or
(1) You can file your comments electronically using the
(2) You can file your comments electronically by using the
(3) You can file a paper copy of your comments by mailing them to the following address. Be sure to reference the project docket number (CP18-89-000) with your submission: Kimberly D. Bose, Secretary, Federal Energy Regulatory Commission, 888 First Street NE, Room 1A, Washington, DC 20426.
Empire proposes to construct and operate gas compression facilities in Tioga County, Pennsylvania and in Ontario, New York. The Empire North Project would provide about 205 million cubic feet per day of incremental firm transportation capacity. The Empire North Project would consist of the following facilities:
• A new 21,000 horsepower (hp) compressor station in Jackson Township, Tioga County, Pennsylvania;
• a new 32,000 hp compressor station in the Town of Farmington, Ontario County, New York;
• modifications of the existing regulator valves and station piping and installation of metering facilities at the existing New Victor Regulator Station in Ontario County, New York;
• minor modifications to the existing Jackson Meter and Regulator Station in Jackson Township, Tioga County, Pennsylvania; and
• upgrading the maximum allowable operating pressure of the Empire Connector Pipeline (ECP) from 1,290 pounds per square inch gauge (psig) to 1,440 psig. The ECP is an existing 76.6-mile-long, 24-inch-diameter pipeline that runs from Victor, New York to Corning, New York in in Ontario, Yates, Schuyler, Chemung, and Steuben Counties, New York.
The general location of the project facilities is shown in appendix A.
Construction of the proposed facilities would disturb about 50.4 acres of land for the aboveground facilities. Following construction, Empire would maintain about 17.5 acres for permanent operation of the project's facilities; the remaining acreage would be restored and revert to former uses.
The National Environmental Policy Act (NEPA) requires the Commission to take into account the environmental impacts that could result from an action whenever it considers the issuance of a Certificate of Public Convenience and Necessity. NEPA also requires us
In the EA we will discuss impacts that could occur as a result of the construction and operation of the proposed project under these general headings:
• Geology and soils;
• water resources, fisheries, and wetlands;
• vegetation and wildlife;
• endangered and threatened species;
• cultural resources;
• land use;
• socioeconomics;
• air quality and noise;
• public safety; and
• cumulative impacts.
We will also evaluate reasonable alternatives to the proposed project or portions of the project, and make recommendations on how to lessen or avoid impacts on the various resource areas.
The EA will present our independent analysis of the issues. The EA will be available in the public record through eLibrary. Depending on the comments received during the scoping process, we may also publish and distribute the EA to the public for an allotted comment period. We will consider all comments on the EA before making our recommendations to the Commission. To ensure we have the opportunity to consider and address your comments, please carefully follow the instructions in the Public Participation section, beginning on page 2.
With this notice, we are asking agencies with jurisdiction by law and/or special expertise with respect to the environmental issues of this project to formally cooperate with us in the preparation of the EA.
In accordance with the Advisory Council on Historic Preservation's implementing regulations for section 106 of the National Historic Preservation Act, we are using this notice to initiate consultation with the applicable State Historic Preservation Offices (SHPO), and to solicit their views and those of other government agencies, interested Indian tribes, and the public on the project's potential effects on historic properties.
The environmental mailing list includes federal, state, and local government representatives and agencies; elected officials; Native American Tribes; other interested parties; and local libraries and newspapers. This list also includes all affected landowners (as defined in the Commission's regulations) who are potential right-of-way grantors, whose property may be used temporarily for project purposes, or who own homes within certain distances of aboveground facilities, and anyone who submits comments on the project. We will update the environmental mailing list as the analysis proceeds to ensure that we send the information related to this environmental review to all individuals, organizations, and government entities interested in and/or potentially affected by the proposed project.
If we publish and distribute the EA, copies of the EA will be sent to the environmental mailing list for public review and comment. If you would prefer to receive a paper copy of the document instead of the CD version or would like to remove your name from the mailing list, please return the attached Information Request (appendix 2).
In addition to involvement in the EA scoping process, you may want to become an “intervenor” which is an official party to the Commission's proceeding. Intervenors play a more formal role in the process and are able to file briefs, appear at hearings, and be heard by the courts if they choose to appeal the Commission's final ruling. An intervenor formally participates in the proceeding by filing a request to intervene. Instructions for becoming an intervenor are in the “Document-less Intervention Guide” under the “e-filing” link on the Commission's website. Motions to intervene are more fully described at
Additional information about the project is available from the Commission's Office of External Affairs, at (866) 208-FERC, or on the FERC website at
In addition, the Commission offers a free service called eSubscription which allows you to keep track of all formal issuances and submittals in specific dockets. This can reduce the amount of time you spend researching proceedings by automatically providing you with notification of these filings, document summaries, and direct links to the documents. Go to
Finally, public sessions or site visits will be posted on the Commission's calendar located at
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.
April 19, 2018, 10:00 a.m.
Room 2C, 888 First Street NE, Washington, DC 20426.
Open.
Agenda.
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.
Take notice that the Commission received the following electric rate filings:
Take notice that the Commission received the following PURPA 210(m)(3) filings:
The filings are accessible in the Commission's eLibrary system by clicking on the links or querying the docket number.
Any person desiring to intervene or protest in any of the above proceedings must file in accordance with Rules 211 and 214 of the Commission's Regulations (18 CFR 385.211 and 385.214) on or before 5:00 p.m. Eastern time on the specified comment date. Protests may be considered, but intervention is necessary to become a party to the proceeding.
eFiling is encouraged. More detailed information relating to filing requirements, interventions, protests, service, and qualifying facilities filings can be found at:
This is a supplemental notice in the above-referenced proceeding of Calpine Mid-Merit II, LLC's application for market-based rate authority, with an accompanying rate tariff, noting that such application includes a request for blanket authorization, under 18 CFR part 34, of future issuances of securities and assumptions of liability.
Any person desiring to intervene or to protest should file with the Federal Energy Regulatory Commission, 888 First Street NE, Washington, DC 20426, in accordance with Rules 211 and 214 of the Commission's Rules of Practice and Procedure (18 CFR 385.211 and 385.214). Anyone filing a motion to intervene or protest must serve a copy of that document on the Applicant.
Notice is hereby given that the deadline for filing protests with regard to the applicant's request for blanket authorization, under 18 CFR part 34, of future issuances of securities and assumptions of liability, is May 1, 2018.
The Commission encourages electronic submission of protests and interventions in lieu of paper, using the FERC Online links at
Persons unable to file electronically should submit an original and 5 copies of the intervention or protest to the Federal Energy Regulatory Commission, 888 First Street NE, Washington, DC 20426.
The filings in the above-referenced proceeding are accessible in the Commission's eLibrary system by clicking on the appropriate link in the above list. They are also available for electronic review in the Commission's Public Reference Room in Washington, DC. There is an eSubscription link on the website that enables subscribers to receive email notification when a document is added to a subscribed docket(s). For assistance with any FERC Online service, please email
This is a supplemental notice in the above-referenced proceeding of Wheelabrator Millbury Inc.'s application for market-based rate authority, with an accompanying rate tariff, noting that such application includes a request for blanket authorization, under 18 CFR part 34, of future issuances of securities and assumptions of liability.
Any person desiring to intervene or to protest should file with the Federal Energy Regulatory Commission, 888 First Street NE, Washington, DC 20426, in accordance with Rules 211 and 214 of the Commission's Rules of Practice and Procedure (18 CFR 385.211 and 385.214). Anyone filing a motion to intervene or protest must serve a copy of that document on the Applicant.
Notice is hereby given that the deadline for filing protests with regard to the applicant's request for blanket authorization, under 18 CFR part 34, of future issuances of securities and assumptions of liability, is May 1, 2018.
The Commission encourages electronic submission of protests and interventions in lieu of paper, using the FERC Online links at
Persons unable to file electronically should submit an original and 5 copies of the intervention or protest to the Federal Energy Regulatory Commission, 888 First Street NE, Washington, DC 20426.
The filings in the above-referenced proceeding are accessible in the Commission's eLibrary system by clicking on the appropriate link in the above list. They are also available for electronic review in the Commission's Public Reference Room in Washington, DC. There is an eSubscription link on the website that enables subscribers to receive email notification when a document is added to a subscribed docket(s). For assistance with any FERC Online service, please email
Environmental Protection Agency (EPA).
Request for nominations for Mobile Sources Technical Review Subcommittee (MSTRS).
The U.S. Environmental Protection Agency (EPA) invites nominations from a diverse range of qualified candidates to be considered for appointment to its Mobile Sources Technical Review Subcommittee (MSTRS). Vacancies are anticipated to be filled by Fall, 2018. Sources in addition to this
Nominations must be postmarked or emailed by May 22, 2018.
Submit nominations to: Courtney McCubbin, Designated Federal Officer, Office of Transportation and Air Quality, U.S Environmental Protection Agency (6401A), 1200 Pennsylvania Avenue NW, Washington, DC 20460. You may also email nominations with subject line MSTRS2018 to
Courtney McCubbin, Designated Federal Officer, U.S. EPA; telephone: (202) 564-2436; email:
The MSTRS is a federal advisory committee chartered under the Federal Advisory Committee Act (FACA), Public Law 92-463. The MSTRS provides the Clean Air Act Advisory Committee (CAAAC) with independent advice, counsel and recommendations on the scientific and technical aspects of programs related to mobile source air pollution and its control.
Through its expert members from diverse stakeholder groups and from its various workgroups, the subcommittee reviews and addresses a wide range of developments, issues and research areas such as emissions modeling, emission standards and standard setting, air toxics, innovative and incentive-based transportation policies, onboard diagnostics, heavy-duty engines, diesel retrofit, and fuel quality. The Subcommittee's website is at:
Members are appointed by the EPA Administrator for three-year terms with the possibility of reappointment to a second term. The MSTRS usually meets two times annually and the average workload for the members is approximately 5 to 10 hours per month. EPA provides reimbursement for travel and other incidental expenses associated with official government business for members who qualify.
EPA is seeking nominations from representatives of nonfederal interests such as:
EPA values and welcomes diversity. To obtain nominations of diverse candidates, EPA encourages nominations of women and men of all racial and ethnic groups.
In selecting members, we will consider technical expertise, coverage of broad stakeholder perspectives, diversity and the needs of the subcommittee.
The following criteria will be used to evaluate nominees:
• The background and experiences that would help members contribute to the diversity of perspectives on the committee (
• Experience in policy engagement across a range of mobility source transportation topics;
• Experience working with future transportation options and shared mobility;
• Experience working with the modeling of mobile source emissions;
• Experience working with producers of passenger cars, engines and trucks, engine and equipment manufacturing;
• Experience working with fuel or renewable fuel producers;
• Experience working with oil refiners, distributors and retailers of mobile source fuels;
• Experience working with clean energy producers;
• Experience working with agricultural producers (corn and other crop products), distillers, processors and shippers of biofuels;
• Experience working with emission control manufacturers, catalyst and filter manufacturers;
• Experience working for State and local environmental agencies or State Air Pollution Control Agencies;
• Experience working for environmental advocacy groups;
• Experience working for environmental and/or community groups;
• Experience working with supply chain logistics and goods movement;
• Experience working with marine port interests;
• Experience in working at the national level on local governments issues;
• Demonstrated experience with environmental and sustainability issues;
• Executive management level experience with membership in broad-based networks;
• Excellent interpersonal, oral and written communication and consensus-building skills;
• Ability to volunteer time to attend meetings two times a year, participate in teleconference and webinar meetings, attend listening sessions with the Administrator or other senior-level officials, develop policy recommendations to the Administrator, and prepare reports and advice letters.
Nominations must include a resume and a short biography describing the professional and educational qualifications of the nominee, as well as the nominee's current business address, email address, and daytime telephone number. Interested candidates may self-nominate.
To help the Agency in evaluating the effectiveness of its outreach efforts, please tell us how you learned of this opportunity.
Please be aware that EPA's policy is that, unless otherwise prescribed by statute, members generally are appointed to three-year terms.
Environmental Protection Agency (EPA).
Notice; request for public comment.
In accordance with the Prospective Purchaser Agreement, notice is hereby given of a proposed administrative settlement concerning the Manual Transmission of Muncie Site in Muncie, Indiana with the following Settling Party: Fourteen91 Loft, LLC. The settlement requires the Settling Party to, if necessary, execute and record a Declaration of Restrictive Covenant; provide access to the Site and exercise due care with respect to existing contamination. The settlement includes a covenant not to sue the Settling Parties pursuant to the Comprehensive Environmental Response, Compensation, and Liability Act or the Resource Conservation and Recovery Act with respect to the Existing Contamination. Existing Contamination is defined as any hazardous substances, pollutants, or contaminants or Waste Material present or existing on or under the Property as of the Effective Date of the Settlement Agreement; any hazardous substances, pollutants, or contaminants or Waste Material that migrated from the Property prior to the Effective Date; and any hazardous substances, pollutants, or contaminants or Waste Material presently at the Site that migrates onto, on, under, or from the Property after the Effective Date.
For thirty (30) days following the date of publication of this notice, the Agency will receive written comments relating to the settlement. The Agency will consider all comments received and may modify or withdraw its consent to the settlement if comments received disclose facts or considerations which indicate that the settlement is inappropriate, improper, or inadequate. The Agency's response to any comments received will be available for public inspection at the EPA, Region 5, Records Center, 77 W Jackson Blvd., 7th Fl., Chicago, Illinois 60604. Commenters may request an opportunity for a public hearing in the affected area, in accordance with Section 7003(d) of RCRA.
Comments must be submitted on or before 30 days after publication in the
The proposed settlement is available for public inspection at the EPA, Region 5, Records Center, 77 W Jackson Blvd., 7th Fl., Chicago, Illinois 60604. A copy of the proposed settlement may be obtained from Peter Felitti, Assoc. Regional Counsel, EPA, Office of Regional Counsel, Region 5, 77 W Jackson Blvd., mail code: C-14J, Chicago, Illinois 60604. Comments should reference the Manual Transmission of Muncie Site, Muncie, Indiana and should be addressed to Peter Felitti, Assoc. Regional Counsel, EPA, Office of Regional Counsel, Region 5, 77 W Jackson Blvd., mail code: C-14J, Chicago, Illinois 60604.
Peter Felitti, Assoc. Regional Counsel, EPA, Office of Regional Counsel, Region 5, 77 W Jackson Blvd., mail code: C-14J, Chicago, Illinois 60604.
The Settling Parties propose to acquire ownership of the former General Motors Corporation North American operation, at 1220 West 8th Street in Muncie, Indiana. The Site is one of the 89 sites that were placed into an Environmental Response Trust (the “Trust”) as a result of the resolution of the 2009 GM bankruptcy. The Trust is administrated by Revitalizing Auto Communities Environmental Response.
Federal Communications Commission.
Notice and request for comments.
As part of its continuing effort to reduce paperwork burdens, and as required by the Paperwork Reduction
The Commission may not conduct or sponsor a collection of information unless it displays a currently valid Office of Management and Budget (OMB) control number. No person shall be subject to any penalty for failing to comply with a collection of information subject to the PRA that does not display a valid OMB control number.
Written comments should be submitted on or before May 17, 2018. If you anticipate that you will be submitting comments, but find it difficult to do so within the period of time allowed by this notice, you should advise the contacts listed below as soon as possible.
Direct all PRA comments to Nicholas A. Fraser, OMB, via email
For additional information or copies of the information collection, contact Cathy Williams at (202) 418-2918. To view a copy of this information collection request (ICR) submitted to OMB: (1) Go to the web page
As part of its continuing effort to reduce paperwork burdens, and as required by the Paperwork Reduction Act (PRA) of 1995 (44 U.S.C. 3501-3520), the Federal Communications Commission (FCC or the Commission) invites the general public and other Federal agencies to take this opportunity to comment on the following information collection. Comments are requested concerning: Whether the proposed collection of information is necessary for the proper performance of the functions of the Commission, including whether the information shall have practical utility; the accuracy of the Commission's burden estimate; ways to enhance the quality, utility, and clarity of the information collected; ways to minimize the burden of the collection of information on the respondents, including the use of automated collection techniques or other forms of information technology; and ways to further reduce the information collection burden on small business concerns with fewer than 25 employees.
Section 20.21(f)(1)(iv)(A)(2)—In order to ensure that consumers are properly informed about which devices are suitable for their use and how to comply with our rules, the Commission required that all Consumer Signal Boosters certified for fixed, in-building operation include a label directing consumers that the device may only be operated in a fixed, in-building location. The Verizon Petitioners state that this additional labeling requirement is necessary to
Section 1.1307(b)(1)—Radiofrequency (RF). This rule requires that a label is affixed to the transmitting antenna that provides adequate notice regarding potential RF safety hazards and references the applicable FCC-adopted limits for RF exposure. Provider Reporting Requirement: In order to facilitate review of wireless providers' behavior regarding Consumer Signal Boosters, the R&O requires that on March 1, 2015, and March 1, 2016, all nationwide wireless providers publicly indicate their status regarding consent for each Consumer Signal Booster that has received FCC certification as listed in a Public Notice to be released by the Wireless Telecommunications Bureau 30 days prior to each reporting date. For each listed Consumer Signal Booster, wireless providers should publicly indicate whether they (1) consent to use of the device; (2) do not consent to use of the device; or (3) are still considering whether or not they will consent to the use of the device.
Section 20.21(h)—By March 1, 2014, all providers who voluntarily consent to the use of Consumer Signal Boosters on their networks must establish a free registration system for their subscribers. At a minimum, providers must collect (1) the name of the Consumer Signal Booster owner and/or operator, if different individuals; (2) the make, model, and serial number of the device; (3) the location of the device; and (4) the date of initial operation. Otherwise, the Commission permits providers to develop their own registration systems to facilitate provider control and interference resolution, providers should collect only such information that is reasonably related to achieving these dual goals. Wireless providers may determine how to collect such information and how to keep it up-to-date. Section 90.219(d)(5)—This rule requires operators of Part 90 Class B signal boosters to register these devices in a searchable on-line database that will be maintained and operated by the Wireless Telecommunications Bureau via delegated authority from the Commission. The Commission believes this will be a valuable tool to resolve interference should it occur.
The Federal Communications Commission will hold an Open Meeting on the subjects listed below on Tuesday, April 17, 2018 which is scheduled to commence at 10:30 a.m. in Room TW-C305, at 445 12th Street SW, Washington, DC.
The meeting site is fully accessible to people using wheelchairs or other mobility aids. Sign language interpreters, open captioning, and assistive listening devices will be provided on site. Other reasonable accommodations for people with disabilities are available upon request. In your request, include a description of the accommodation you will need and a way we can contact you if we need more information. Last minute requests will be accepted, but may be impossible to fill. Send an email to:
Additional information concerning this meeting may be obtained from the Office of Media Relations, (202) 418-0500; TTY 1-888-835-5322. Audio/Video coverage of the meeting will be broadcast live with open captioning over the internet from the FCC Live web page at
For a fee this meeting can be viewed live over George Mason University's Capitol Connection. The Capitol Connection also will carry the meeting live via the internet. To purchase these services, call (703) 993-3100 or go to
Federal Communications Commission.
Notice and request for comments.
As part of its continuing effort to reduce paperwork burdens, and as required by the Paperwork Reduction Act of 1995 (PRA), the Federal Communications Commission (FCC or Commission) invites the general public and other Federal agencies to take this opportunity to comment on the following information collections. Comments are requested concerning: Whether the proposed collection of information is necessary for the proper performance of the functions of the Commission, including whether the information shall have practical utility; the accuracy of the Commission's burden estimate; ways to enhance the quality, utility, and clarity of the information collected; ways to minimize the burden of the collection of information on the respondents, including the use of automated collection techniques or other forms of information technology; and ways to further reduce the information collection burden on small business concerns with fewer than 25 employees.
The FCC may not conduct or sponsor a collection of information unless it displays a currently valid Office of Management and Budget (OMB) control number. No person shall be subject to any penalty for failing to comply with
Written PRA comments should be submitted on or before June 18, 2018. If you anticipate that you will be submitting comments, but find it difficult to do so within the period of time allowed by this notice, you should advise the contact listed below as soon as possible.
Direct all PRA comments to Cathy Williams, FCC, via email
For additional information about the information collection, contact Cathy Williams at (202) 418-2918.
FCC Form 315 and applicable exhibits/explanations are required to be filed when applying for transfer of control of an entity holding an AM, FM, LPFM or TV broadcast station construction permit or license. In addition, the applicant must notify the Commission when an approved transfer of control of a broadcast station construction permit or license has been consummated.
Due to the similarities in the information collected by these two forms, OMB has assigned both forms OMB Control Number 3060-0031.
47 CFR 73.3580 requires local public notice in a newspaper of general circulation published in the community in which a station is located of the filing of all applications for transfer of control or assignment of the license/permit. This notice must be completed within 30 days of the tendering of the application. This notice must be published at least twice a week for two consecutive weeks in a three-week period. A copy of this notice and the application must be placed in the station's public inspection file along with the application, pursuant to Section 73.3527. Additionally, an applicant for transfer of control of a license must broadcast the same notice over the station at least once daily on four days in the second week immediately following the tendering for filing of the application.
Board of Governors of the Federal Reserve System (“Board”) and Departmental Offices, Department of the Treasury (“Treasury”) (collectively, the “Agencies”).
Joint notice, request for comment.
The Agencies invite comment on a proposal to extend for three years, without revision, the mandatory recordkeeping requirements associated with a joint rule implementing the Unlawful internet Gambling Enforcement Act of 2006 (the “Act”).
Comments must be submitted on or before June 18, 2018.
Interested parties are invited to submit written comments to either or both of the Agencies. All comments, which should refer to the Office of Management and Budget (OMB) control numbers, will be shared between the Agencies. Direct all written comments as follows:
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All public comments are available from the Board's website at
A copy of the PRA OMB submission, including the proposed reporting form and instructions, supporting statement, and other documentation will be placed into OMB's public docket files, once approved. Requests for additional information or a copy of the collection may be obtained by contacting:
The Agencies invite public comment on the following information collection. Comments are invited on the following:
a. Whether the proposed collection of information is necessary for the proper performance of the Federal Reserve's functions; including whether the information has practical utility;
b. The accuracy of the Federal Reserve's estimate of the burden of the proposed information collection, including the validity of the methodology and assumptions used;
c. Ways to enhance the quality, utility, and clarity of the information to be collected;
d. Ways to minimize the burden of information collection on respondents, including through the use of automated collection techniques or other forms of information technology; and
e. Estimates of capital or startup costs and costs of operation, maintenance, and purchase of services to provide information.
Comments submitted in response to this notice will be shared between the Agencies. All comments received, including attachments and other supporting materials, are part of the public record and will be included in the submission to the Office of Management and Budget (OMB).
For the purpose of estimating burden and accounting for it with OMB, the total number of depository institutions listed for each Agency includes the number of entities regulated by the Agency and half of the remaining depository institutions and third-party processors. Each Agency is also accounting for the burden for half of the card system operators and money transmitting business operators to which the Agencies estimate the final rule applies.
By the Department of the Treasury.
Agency for Healthcare Research and Quality, HHS.
Notice.
This notice announces the intention of the Agency for Healthcare Research and Quality (AHRQ) to request that the Office of Management and Budget (OMB) approve the proposed information collection project “Outcome Measure Repository (OMR).”
This proposed information collection was previously published in the
Comments on this notice must be received by May 17, 2018.
Written comments should be submitted to: AHRQ's OMB Desk Officer by fax at (202) 395-6974 (attention: AHRQ's desk officer) or by email at
Doris Lefkowitz, AHRQ Reports Clearance Officer, (301) 427-1477, or by email at
In accordance with the Paperwork Reduction Act, 44 U.S.C. 3501-3521, AHRQ invites public comment on this proposed information collection. In accordance with the agency's mission, AHRQ developed the Outcome Measure Repository (OMR), a web-based database with the purpose of providing a readily available public resource that includes definitions of outcome measures associated with patient registries. The information being collected in each OMR record will be visible to the public and readily available for public use.
This effort is in alignment the AHRQ Registry of Patient Registries (RoPR), which provides a central point of collection for information about all patient registries in the United States. The RoPR furthers AHRQ's goals to enhance the description of the quality, appropriateness, and effectiveness of health services, and patient registries in particular, in a more readily available, central location by enhancing patient registry information, extracted from
The development of the OMR continues these efforts, and aims to achieve the following objectives:
(1) Provide a searchable database of outcome measures used in patient registries in the United States to promote collaboration, reduce redundancy, and improve transparency;
(2) Facilitate the use of standardized data elements and outcome measures; and
(3) Facilitate the identification of potential areas of harmonization.
The OMR system will be linked to RoPR in two key ways. First, users entering registry information in the RoPR system will be able to associate OMR measure records with the RoPR registry records, and, measure stewards listing a measure record in the OMR system will be able to associate the measure with an existing patient registry in RoPR. Second, users will be able to access both databases with a single account (
This study is being conducted by AHRQ through its contractor, L&M Policy Research and subcontractors Truven Health Analytics, an IBM Company, and OM1, pursuant to AHRQ's statutory authority to conduct and support research on health care and on systems for the delivery of such care, including activities with respect to the outcomes, cost, cost-effectiveness, and use of health care services and access to such services, and with respect to health statistics and database development. 42 U.S.C. 299a(a)(3) and (8).
To achieve the three objectives of this project, outcome measures and related sub-elements from measure stewards who populate the OMR database system will be collected.
Users of the OMR will primarily fall into two types: Those stewarding a registry who will provide information on the data they collect in their registry, and those who will search for information about how a particular type of outcome measure is collected within patient registries. For the OMR to succeed, the first group of users must be able to enter information into the system easily and efficiently. The second group of users must be able to find sufficient information efficiently on outcome measures to identify items for use in their own registry or research. Meeting the needs of both sets of users is an important consideration in the design of the OMR.
Exhibit 1 shows the estimated annualized burden hours for the respondent's time to contribute to the OMR.
Based on the number of respondents submitting RoPR records in 2016 (65 respondents), it is expected that a similar number of stakeholders (approximately 70 respondents) will provide measure information in the OMR on an annual basis.
All users will complete required fields on the “Measure Profile” form. Some users may also choose to complete the “Sub-Element Profile” form for one or more sub-elements associated with a given measure although this is not required. The number of sub-elements for a given measure is expected to vary widely. Many users may not provide sub-element information, while others may include five or more. It is expected that on average, measure stewards will enter information for two sub-elements.
In September 2017, Truven Health Analytics consulted with several stakeholders and used a sample of existing measure definitions to estimate the time required to enter all OMR fields. The sample included measures representing a range of depth and complexity. For example, one measure record contained no sub-element information, only required fields, and short responses to open text fields (
As a result of the knowledge gained during these processes, it is estimated that it will take users 16 minutes, on average, to enter manually the additional fields added through the self-registration process (an average of 12 minutes to complete the Measure Profile form and 4 minutes to complete two Sub-Element Profile sub-forms). If 70 respondents complete the Measure Profile form and two Sub-Element Profile sub-forms, the estimated annualized burden would be 18.7 hours total.
Exhibit 2 shows the estimated cost burden associated with the respondent's time to participate in the OMR. The total cost burden to respondents is estimated at an average of $711.72 annually.
In accordance with the Paperwork Reduction Act, comments on AHRQ's information collection are requested with regard to any of the following: (a) Whether the proposed collection of information is necessary for the proper performance of AHRQ health care research and health care information dissemination functions, including whether the information will have practical utility; (b) the accuracy of AHRQ's estimate of burden (including hours and costs) of the proposed collection(s) of information; (c) ways to enhance the quality, utility and clarity of the information to be collected; and (d) ways to minimize the burden of the collection of information upon the respondents, including the use of automated collection techniques or other forms of information technology.
Comments submitted in response to this notice will be summarized and included in the Agency's subsequent request for OMB approval of the proposed information collection. All comments will become a matter of public record.
Centers for Disease Control and Prevention (CDC), Department of Health and Human Services (HHS).
Notice with comment period.
The Centers for Disease Control and Prevention (CDC), as part of its continuing effort to reduce public burden and maximize the utility of government information, invites the general public and other Federal agencies the opportunity to comment on a proposed and/or continuing information collection, as required by the Paperwork Reduction Act of 1995. This notice invites comment on a proposed information collection project titled, Environmental Health Specialists Network (EHS-NET) Program Generic Package. The goal of this food safety research program is to collect data in retail food establishments that will identify and help to understand environmental factors (
CDC must receive written comments on or before June 18, 2018.
You may submit comments, identified by Docket No. CDC-2018-0031 by any of the following methods:
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To request more information on the proposed project or to obtain a copy of the information collection plan and instruments, contact Leroy A. Richardson, Information Collection Review Office, Centers for Disease Control and Prevention, 1600 Clifton Road NE, MS-D74, Atlanta, Georgia 30329; phone: 404-639-7570; Email:
Under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3520), Federal agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. In addition, the PRA also requires Federal agencies to provide a 60-day notice in the
The OMB is particularly interested in comments that will help:
1. 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;
2. 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;
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 through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology,
5. Assess information collection costs.
Environmental Health Specialists Network (EHS-NET) Program Generic Package (OMB Control Number 0920-0792; expiration date 9/30/2018)—Revision—National Center for Environmental Health (NCEH), Centers for Disease Control and Prevention (CDC).
The National Center for Environmental Health (NCEH), Centers for Disease Control and Prevention (CDC), is requesting a three-year Office of Management and Budget approval for the revision Generic Information Collection plan titled the
The EHS-Net program focuses on identifying the environmental causes of foodborne illness. In October 2008, OMB approved the EHS-Net program generic information collection plan. OMB approved renewal collections in both 2012 and 2015. To date, EHS-Net has conducted five individual data collections under this plan.
CDC seeks a revision to conduct information collections through 2021. The CDC plans to revise the plan in the following ways:
(1) The burden hours have increased to allow for additional statistical designs. The number of restaurants per site (8 EHS-Net sites, which has remained the same) has increased from 47 to 50 restaurants (totaling 400 restaurants); the sample size was increased to detect a greater odds ratio and establish a stronger power.
(2) The number of respondents has increased to gather additional food worker responses per establishment. Collecting data from additional food workers (increased to 10 food workers per restaurant from 1 food worker per restaurant, totaling 4,000 food workers) will help minimize the potential bias of only having one worker represent all of food workers in a given establishment. Additionally, going forward the restaurant observation data collection by the health department (HD) staff will also be included in the burden table.
(3) We expect to conduct up to three studies in a 5-year cooperative period; based on a more accurate study schedule in a 5-year EHS-Net cooperative agreement. Therefore, due to an increase in the number of restaurants, food workers interviews and addition of restaurant observation activity the estimated annual burden hours expected to increase from 295 to 1,777 annual hours.
The goal of this information collection is to improve food safety and reduce foodborne illness, which supports the U.S. Department of Health and Human Services' Healthy People 2020 Goal. Reducing foodborne illness first requires identification and understanding of the environmental factors that cause these illnesses. We need to know how and why food becomes contaminated with foodborne illness pathogens. This information can then be used to determine effective food safety prevention methods. Ultimately, these actions can lead to increased regulatory program effectiveness and decreased foodborne illness. The purpose of the information collection is to gather data that will help us identify and understand environmental factors associated with foodborne illness. Specifically, the information will be used to:
(a) Describe retail food establishment food handling and food safety practices and manager/worker and establishment characteristics,
(b) Determine how retail food establishment and worker characteristics are related to food handling and food safety practices.
The program Environmental Health Specialists Network (EHS-Net), conducted by a collaborative project of CDC, Food and Drug Administration (FDA), U.S. Department of Agriculture (USDA), and local and state sites.
Environmental factors associated with foodborne illness include both food safety practices (
For each data collection, CDC will collect data in approximately 50 retail food establishments per site. Thus, there will be approximately 400 establishments per data collection (an estimated 8 sites with 50 establishments).
The total estimated annual burden for each data collection will be 1,777 hours.
Centers for Medicare & Medicaid Services (CMS), HHS.
Notice with request for comment.
This proposed notice acknowledges the receipt of an application from DNV GL—Healthcare for continued recognition as a national accrediting organization for hospitals that wish to participate in the Medicare or Medicaid programs. The statute requires that we publish, within 60 days of receipt of an organization's complete application, a notice that identifies the national accrediting body making the request, describes the nature of the request, and provides at least a 30-day public comment period.
To be assured consideration, comments must be received at one of the addresses provided below, no later than 5 p.m. on May 17, 2018.
In commenting, refer to file code CMS-3357-PN. 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
Karena Meushaw (410) 786-6609, Patricia Chmielewski, (410) 786-6899 or Monda Shaver, (410) 786-3410.
Under the Medicare program, eligible beneficiaries may receive covered services from a hospital, provided that certain requirements are met. Section 1861(e) of the Social Security Act (the Act), establishes distinct criteria for facilities seeking designation as a hospital. Regulations concerning provider agreements are at 42 CFR part 489 and those pertaining to activities relating to the survey and certification of facilities are at 42 CFR part 488. The regulations at 42 CFR part 482 specify the minimum conditions that a hospital must meet to participate in the Medicare program.
Generally, to enter into an agreement, a hospital must first be certified by a state survey agency as complying with the conditions or requirements set forth in part 482 of our regulations. Thereafter, the hospital is subject to regular surveys by a state survey agency to determine whether it continues to meet these requirements. There is an alternative; however, to surveys by state agencies.
Section 1865(a)(1) of the Act provides that, if a provider entity demonstrates through accreditation by an approved national accrediting organization that all applicable Medicare conditions are met or exceeded, we may deem those provider entities as having met the requirements. Accreditation by an accrediting organization is voluntary and is not required for Medicare participation.
If an accrediting organization is recognized by the Secretary of the Department of Health and Human Services (the Secretary) as having standards for accreditation that meet or exceed Medicare requirements, any provider entity accredited by the national accrediting body's approved program may be deemed to meet the Medicare conditions. A national accrediting organization applying for approval of its accreditation program under part 488, subpart A, must provide the Centers for Medicare and Medicaid Services (CMS) with reasonable assurance that the accrediting organization requires the accredited provider entities to meet requirements that are at least as stringent as the Medicare conditions. Our regulations concerning the approval of accrediting organizations are set forth at § 488.5. The regulations at § 488.5(e)(2)(i) require accrediting organizations to reapply for continued approval of its accreditation program every 6 years or
Section 1865(a)(2) of the Act and our regulations at § 488.5 require that our findings concerning review and approval of a national accrediting organization's requirements consider, among other factors, the applying accrediting organization's requirements for accreditation; survey procedures; resources for conducting required surveys; capacity to furnish information for use in enforcement activities; monitoring procedures for provider entities found not in compliance with the conditions or requirements; and ability to provide us with the necessary data for validation.
Section 1865(a)(3)(A) of the Act further requires that we publish, within 60 days of receipt of an organization's complete application, a notice identifying the national accrediting body making the request, describing the nature of the request, and providing at least a 30-day public comment period. We have 210 days from the receipt of a complete application to publish notice of approval or denial of the application.
The purpose of this proposed notice is to inform the public of DNV GL's request for continued approval of its hospital accreditation program. This notice also solicits public comment on whether DNV GL's requirements meet or exceed the Medicare conditions of participation (CoPs) for hospitals.
DNV GL submitted all the necessary materials to enable us to make a determination concerning its request for continued approval of its hospital accreditation program. This application was determined to be complete on February 28, 2018. Under section 1865(a)(2) of the Act and our regulations at § 488.5 (Application and re-application procedures for national accrediting organizations), our review and evaluation of DNV GL will be conducted in accordance with, but not necessarily limited to, the following factors:
• The equivalency of DNV GL's standards for hospitals as compared with CMS' hospital CoPs.
• DNV GL's survey process to determine the following:
++ The composition of the survey team, surveyor qualifications, and the ability of the organization to provide continuing surveyor training.
++ The comparability of DNV GL's processes to those of state agencies, including survey frequency, and the ability to investigate and respond appropriately to complaints against accredited facilities.
++ DNV GL's processes and procedures for monitoring a hospital found out of compliance with the DNV GL's program requirements. These monitoring procedures are used only when the DNV GL identifies noncompliance. If noncompliance is identified through validation reviews or complaint surveys, the state survey agency monitors corrections as specified at § 488.9(c).
++ DNV GL's capacity to report deficiencies to the surveyed facilities and respond to the facility's plan of correction in a timely manner.
++ DNV GL's capacity to provide CMS with electronic data and reports necessary for effective validation and assessment of the organization's survey process.
++ The adequacy of DNV GL's staff and other resources, and its financial viability.
++ DNV GL's capacity to adequately fund required surveys.
++ DNV GL's policies with respect to whether surveys are announced or unannounced, to assure that surveys are unannounced.
++ DNV GL's agreement to provide CMS with a copy of the most current accreditation survey together with any other information related to the survey as we may require (including corrective action plans).
Upon completion of our evaluation, including evaluation of public comments received as a result of this notice, we will publish a final notice in the
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. Chapter 35).
Because of the large number of public comments we normally receive on
Food and Drug Administration, HHS.
Notice.
The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995 (the PRA).
Fax written comments on the collection of information by May 17, 2018.
To ensure that comments on the information collection are received, OMB recommends that written comments be faxed to the Office of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, Fax: 202-395-7285, or emailed to
Amber Sanford, Office of Operations, Food and Drug Administration, Three White Flint North, 10A-12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-8867,
In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed
The 2009 Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act) (Pub. L. 111-31) amended the Federal Food, Drug, and Cosmetic Act (FD&C Act) to grant FDA authority to regulate the manufacture, marketing, and distribution of tobacco products to protect public health and to reduce tobacco use by minors. Section 1003(d)(2)(D) of the FD&C Act (21 U.S.C. 393(d)(2)(D)) supports the development and implementation of FDA public education campaigns related to tobacco use. Accordingly, FDA is currently developing and implementing a youth-targeted public education campaign (`Fresh Empire') to help prevent tobacco use among multicultural youth and thereby reduce the public health burden of tobacco. The campaign features events, advertisements on television and radio and in print, digital communications including social media, and other forms of media.
Evaluation is an essential organizational practice in public health and a systematic way to account for and improve public health actions. Comprehensive evaluation of FDA's multicultural public education campaign will be used to document whether the intended audience is aware of and understands campaign messages, and whether campaign exposure influences specific cognitive outcomes related to tobacco use that are targeted by the campaign.
FDA is in the process of evaluating the effectiveness of its multicultural youth tobacco prevention campaign through an outcome evaluation study that follows the multiple, discrete waves of media advertising planned for the campaign. All information collected is integral to that evaluation.
FDA's
To date, the pre-test and three post-test surveys have been conducted. Information has been collected about youth awareness of and exposure to campaign events and advertisements and about tobacco-related knowledge, attitudes, beliefs, intentions, and use. Information has also been collected on demographic variables including age, sex, race/ethnicity, grade level, and primary language.
All information is voluntarily provided and is being collected through in-person and web-based questionnaires. Youth respondents were recruited from two sources: (1) A sample drawn from 30 U.S. media markets gathered using an address-based postal mail sampling of U.S. households for the outcome evaluation, and (2) targeted social media (
This study is being conducted in support of the provisions of the Tobacco Control Act that require FDA to protect the public health and to educate the population about the risks and potential risks of tobacco use. The information being collected is necessary to inform FDA's efforts towards these goals and to measure the effectiveness and public health impact of the campaign. Data from the outcome evaluation are being used to estimate awareness of and exposure to the campaign among youth in target markets where the campaign is active. Data are also being used to examine statistical associations between exposure to the campaign and subsequent changes in specific outcomes of interest, which include knowledge, attitudes, and beliefs related to tobacco use.
FDA requests OMB approval to extend OMB approval of the evaluation of FDA's multicultural youth tobacco public education campaign and to add two additional waves of data collection with existing youth in the study. To accommodate these two additional surveys, FDA requests approval to increase the number of burden hours under the existing control number. The fourth post-test survey will begin in July 2018. The fifth post-test survey will begin in February 2019. As was done in earlier post-test surveys, new youth will be recruited to participate to make up for attrition.
A total of 2,100 youth will voluntarily complete questionnaires for the fourth post-test survey, and the same number will complete questionnaires for the fifth post-test survey. These respondents will include existing youth who have participated in one or more surveys previously (“Longitudinal Cohort”) and new youth recruited via a mail-based screener or social media ads (“Cross-Sectional Refresher Sample”). Based on earlier response rates and longitudinal respondents aging out of the eligibility criteria (over the age of 18), we expect to need to recruit a larger number of cross-sectional respondents than in previous waves. We estimate that approximately 600 longitudinal youth and 1,500 cross-sectional youth will voluntarily participate in each of the fourth and fifth post-test surveys. With an estimated burden of 45 minutes per respondent, this adds 450 hours for longitudinal respondents and 1,125 hours for cross-sectional respondents for each of the fourth and fifth post-test evaluation surveys.
A mail-based screener was one of the methods used to identify eligible youth for the pre-test survey. This method will be used during the fourth post-test survey to recruit new youth aged 12 to 17 to ensure that the sample composition is similar across rounds of data collection. As was done during the pre-test survey, parents or guardians will be asked to provide consent and their contact information on this form. For the fourth post-test survey, the 5-minute youth screener and the 1-minute parental consent will be completed by 9,869 households for a total of 822 burden hours for youth and an additional 164 hours for the parents or guardians. This method will not be used during the fifth post-test survey, for which new participants will be recruited only via social media.
We will continue to recruit new youth through social media (
As was done previously, eligible youth aged 13 to 14 who complete the
With these additions, the estimated number of voluntary respondents/responses for all waves of data collection for the study is 107,743, and the total burden is estimated at 15,135 hours—an estimated increase of 4,813 hours from the last approval.
In the
FDA estimates the burden of this collection of information as follows:
Food and Drug Administration, HHS.
Notice.
The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.
Fax written comments on the collection of information by May 17, 2018.
To ensure that comments on the information collection are received, OMB recommends that written comments be faxed to the Office of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, Fax: 202-395-7285, or emailed to
Amber Sanford, Office of Operations, Food and Drug Administration, Three White Flint North, 10A-12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-8867,
In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance.
This information collection supports Agency regulations and accompanying guidance. Section 513(g) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 360c(g)) provides a means for obtaining the Agency's views about the classification and regulatory requirements that may be applicable to a particular device. Section 513(g) provides that, within 60 days of the receipt of a written request of any person for information respecting the class in which a device has been classified or the requirements applicable to a device under the FD&C Act, the Secretary of Health and Human Services shall provide such person a written statement of the classification (if any) of such device and the requirements of the FD&C Act applicable to the device. Regulations governing medical device classification procedures are codified under 21 CFR part 860.
The guidance document entitled “FDA and Industry Procedures for Section 513(g) Requests for Information Under the Federal Food, Drug, and Cosmetic Act; Guidance for Industry and Food and Drug Administration Staff” establishes procedures for submitting, reviewing, and responding to requests for information respecting the class in which a device has been classified or the requirements applicable to a device under the FD&C Act that are submitted in accordance with section 513(g) of the FD&C Act. FDA does not review data related to substantial equivalence or safety and effectiveness in a 513(g) request for information. FDA's responses to 513(g) requests for information are not device classification decisions and do not constitute FDA clearance or approval for marketing. Classification decisions and clearance or approval for marketing require submissions under different sections of the FD&C Act.
Relatedly, the FD&C Act, as amended by the Food and Drug Administration Amendments Act of 2007 (Pub. L. 110-85), requires FDA to collect user fees for 513(g) requests for information. The guidance document entitled “Guidance for Industry and Food and Drug Administration Staff; User Fees for 513(g) Requests for Information” assists FDA staff and regulated industry by describing the user fees associated with 513(g) requests. The Medical Device User Fee Cover Sheet (Form FDA 3601), which accompanies the supplemental material described in this information collection is approved under OMB control number 0910-0511.
In the
We therefore retain the currently approved burden estimate for the information collection, which is as follows:
Respondents to the collection of information are mostly device manufacturers; however, anyone may submit a 513(g) request for information. The total number of annual responses is based on the average number of 513(g) requests received each year by the Agency.
Food and Drug Administration, HHS.
Notice of availability.
The Food and Drug Administration (FDA or we) is announcing the availability of a revised final guidance for industry entitled “Listing of Ingredients in Tobacco Products.” The revised guidance document is intended to assist persons making tobacco product ingredient submissions to FDA as required by the Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act).
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 the revised draft guidance to the Center for Tobacco Products, Food and Drug Administration, Document Control Center, 10903 New Hampshire Ave., Bldg. 71, Rm. G335, Silver Spring, MD 20993-0002. Send two self-addressed adhesive labels to assist that office in processing your requests. See the
Katherine Collins or Deirdre Jurand, Center for Tobacco Products, Food and Drug Administration, Document Control Center, 10903 New Hampshire Ave., Bldg. 71, Rm. G335, Silver Spring, MD 20993-0002, 1-877-287-1373, email:
We are announcing the availability of a revised guidance for industry entitled “Listing of Ingredients in Tobacco Products.” The revised guidance document is intended to assist persons making tobacco product ingredient submissions to FDA as required by the Tobacco Control Act.
We are issuing this guidance consistent with our good guidance practices (GGP) regulation (§ 10.115 (21 CFR 10.115)). We are implementing this guidance without prior public comment because we have determined that prior public participation is not feasible or appropriate given the requirement that ingredient listing submissions be submitted by May 8, 2018 (§ 10.115(g)(2)). We made this determination because FDA needs to timely communicate that the guidance presents a less burdensome policy that is consistent with the public health and clarifies ways in which tobacco product manufacturers and importers can submit ingredient listing submissions as required by section 904(a)(1) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 387d(a)(1)). Although this guidance document is immediately effective, it remains subject to comment in accordance with FDA's GGP regulation.
The Tobacco Control Act, enacted on June 22, 2009, amends the FD&C Act and provides FDA with the authority to regulate the manufacture, marketing, and distribution of tobacco products to protect the public health (Pub. L. 111-31, 123 Stat. 1776). Among its many provisions, the Tobacco Control Act added section 904 to the FD&C Act, establishing requirements for tobacco product ingredient submissions.
This revised 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 listing of ingredients in tobacco products. 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 revised guidance refers to previously approved collections of information found in FDA regulations. The revised draft guidance includes information and recommendations for how to provide ingredient listing submissions for tobacco products. 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 section 904(a)(1) of the FD&C Act have been approved under OMB control number 0910-0650.
Persons with access to the internet may obtain an electronic version of the revised guidance at either
Food and Drug Administration, HHS.
Notice.
The Food and Drug Administration (FDA) is announcing that, as required by the Federal Advisory Committee Act, the Agency has filed with the Library of Congress the annual reports of those FDA advisory committees that held closed meetings during fiscal year 2017.
Copies are available at the Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, 240-402-7500. You also may access the docket at
Russell Fortney, Director, Advisory Committee Oversight and Management Staff, Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993-0002, 301-796-1068.
Under section 10(d) of the Federal Advisory Committee Act (5 U.S.C. app.) and 21 CFR 14.60(d), FDA has filed with the Library of Congress the annual reports for the following FDA advisory committees that held closed meetings during the period October 1, 2016, through September 30, 2017:
(1) The Library of Congress, Madison Building, Newspaper and Current Periodical Reading Room, 101 Independence Ave. SE, Rm. 133, Washington, DC 20540; and
(2) Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
Food and Drug Administration, HHS.
Notice.
The sixth iteration of the Prescription Drug User Fee Act (PDUFA VI), incorporated as part of the FDA Reauthorization Act of 2017 (FDARA), highlights the goal of advancing model-informed drug development (MIDD). The Food and Drug Administration (FDA or Agency) is announcing a pilot program that affords sponsors or applicants who are selected for participation the opportunity to meet with Agency staff to discuss MIDD approaches in medical product development. Meetings under the pilot program will be conducted by FDA's Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER) during fiscal years 2018 to 2022. This pilot program is being conducted to fulfill FDA's performance commitment under PDUFA VI. For this pilot program, MIDD is defined as the application of exposure-based, biological, and/or statistical models derived from preclinical and clinical data sources to address drug development and/or regulatory issues (see Supplementary Information, I. Background, and II. Eligibility and Selection for Participation of this notice). For each approved proposal, the pilot program consists of two meetings between sponsors or applicants and the relevant center and will provide an opportunity for drug developers and FDA to discuss the application of MIDD approaches to the development and regulatory evaluation of medical products in development.
FDA will accept requests to participate in the program on a continuous basis beginning on April 17, 2018 through June 15, 2022. See section III of this notice for instructions about how to request participation in the pilot program. Meeting-granted and -denied decisions will be made the last 2 weeks of each quarter of the fiscal year based on submissions received to date. Requesters will receive a meeting-granted or -denied notification the first week of the new quarter.
The pilot program meetings will begin in Q4 of FY 2018 (July 1-September 30, 2018), and run through Q4 of FY 2022 (September 30, 2022). Proposals not selected for a given quarter will be so notified by the Agency. Sponsors who are not chosen to participate in the pilot program may seek Agency interaction through existing channels (
Comments about this pilot program can be submitted until May 17, 2018. You may submit comments about the MIDD pilot meetings program 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
Under FDARA FDA agreed, in accordance with the “PDUFA Reauthorization Performance Goals and Procedures Fiscal Years 2018 Through 2022: I. Ensuring the Effectiveness of the Human Drug Review Program, Part J. Enhancing Regulatory Decision Tools to Support Drug Development and Review” to provide information on how a sponsor can apply to participate in a pilot meetings program with FDA to discuss MIDD approaches (
FDA is announcing this pilot meetings program to satisfy the above-mentioned commitment and to facilitate MIDD approaches. This excludes statistical designs involving complex adaptations, Bayesian methods, or other features requiring computer simulations to determine the operating characteristics of a confirmatory clinical trial. MIDD approaches use a variety of quantitative methods to help balance the risks and benefits of drug products in development. When successfully applied, MIDD approaches can improve clinical trial efficiency, increase the probability of regulatory success, and optimize drug dosing/therapeutic individualization in the absence of dedicated trials.
The goal of the early meeting discussions granted under this pilot program is to provide advice on how specific, proposed MIDD approaches can be used in a specific drug development program. FDA has committed to accepting two to four meeting requests quarterly each fiscal year. The meetings granted will include an initial and followup meeting on the same drug development issues within the span of approximately 120 days.
The listed eligibility factors and procedures outlined in this
The requester should be a drug/biologics development company (interested consortia or software/device developer should come in partnership with a drug development company) and have an investigational new drug application (IND) or pre-IND (PIND) number for the relevant program. Recognizing that FDA will learn both from the number and types of submissions received for consideration into the pilot program, FDA welcomes submissions related to any relevant MIDD topics. However, given that the Agency expects to grant two to four meeting requests per quarter as part of the pilot program, the Agency will initially prioritize selecting requests that focus on:
• Dose selection or estimation (
• Clinical trial simulation (
• Predictive or mechanistic safety evaluation (
The MIDD pilot program will be jointly administered by CDER's Office of Clinical Pharmacology, in the Office of Translational Sciences, which is the point of contact for all communications for CDER products, and CBER's Office of Biostatistics and Epidemiology, which is the point of contact for all communications for CBER products.
Meeting requests should be submitted electronically to the relevant application (
Include the following information in the meeting request (no more than three to four pages):
1. Product name.
2. Application number.
3. Chemical name and structure.
4. Proposed indication(s) or context of product development.
5. Brief statement of the purpose and objectives of the meeting. The statement should include a brief background of the MIDD issues underlying the agenda.
6. MIDD approach(es) considered for the product under development and how MIDD can assess uncertainties about issues (
7. List of issues for discussion with the Agency about the specific MIDD proposed approach for the applicable drug development program.
Sponsors or applicants whose meeting requests are granted as part of the pilot program should submit a meeting information package electronically with “MIDD Pilot Program Meeting Package for CDER” (CDER applications) or “MIDD Pilot Program Meeting Package for CBER” (CBER applications) in the subject line no later than 30 days before each (initial and followup) meeting. This meeting package should include the following information:
1. Product name.
2. Application number.
3. Chemical name and structure.
4. Proposed indication(s) or context of product development.
5. Background section that includes a brief history of the development program and the events leading up to the meeting, and the status of product development.
6. Proposed agenda, including estimated times needed for discussion of each agenda item.
7. List of questions for discussion with a brief summary for each question to explain the need or context for the question.
8. Drug development issue (
A meeting summary will be sent to the requester within 60 days of each meeting.
This notice refers to collections of information that 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 collection of information resulting from formal meetings between sponsors or applicants and FDA has been approved under OMB control number 0910-0429. The collection of information in 21 CFR part 312 (INDs) has been approved under OMB control number 0910-0014.
Food and Drug Administration, HHS.
Notice.
The Food and Drug Administration (FDA, we, or Agency) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.
Fax written comments on the collection of information by May 17, 2018.
To ensure that comments on the information collection are received, OMB recommends that written comments be faxed to the Office of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, Fax: 202-395-7285, or emailed to
Ila S. Mizrachi, Office of Operations, Food and Drug Administration, Three White Flint North, 10A-12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-7726,
In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance.
All blood and blood components introduced or delivered for introduction into interstate commerce are subject to section 351(a) of the Public Health Service Act (PHS Act) (42 U.S.C. 262(a)). Section 351(a) requires that manufacturers of biological products, which include blood and blood components intended for further manufacturing into products, have a license, issued upon a demonstration that the product is safe, pure, and potent and that the manufacturing establishment meets all applicable standards, including those prescribed in the FDA regulations designed to ensure the continued safety, purity, and potency of the product. In addition, under section 361 of the PHS Act (42 U.S.C. 264), by delegation from the Secretary of Health and Human Services, FDA may make and enforce regulations necessary to prevent the introduction, transmission, or spread of communicable diseases from foreign countries into the States or possessions, or from one State or possession into any other State or possession.
Section 351(j) of the PHS Act states that the Federal Food, Drug, and Cosmetic Act (FD&C Act) also applies to biological products. Blood and blood components for transfusion or for further manufacturing into products are drugs, as that term is defined in section 201(g)(1) of the FD&C Act (21 U.S.C. 321(g)(1)). Because blood and blood components are drugs under the FD&C Act, blood and plasma establishments must comply with the provisions and related regulatory scheme of the FD&C Act. For example, under section 501 of the FD&C Act (21 U.S.C. 351), drugs are deemed “adulterated” if the methods used in their manufacturing, processing, packing, or holding do not conform to current good manufacturing practice (CGMP) and related regulations.
The CGMP regulations (part 606) (21 CFR part 606) and related regulations implement FDA's statutory authority to ensure the safety, purity, and potency of blood and blood components. The public health objective in testing human blood donations for evidence of relevant transfusion-transmitted infections and in notifying donors is to prevent the transmission of relevant transfusion-transmitted infections. For example, the “lookback” requirements are intended to help ensure the continued safety of the blood supply by providing necessary information to consignees of blood and blood components and appropriate notification of recipients of blood components that are at increased risk for transmitting human immunodeficiency virus (HIV) or hepatitis C virus (HCV) infection.
The information collection requirements in the CGMP, donation testing, donor notification, and “lookback” regulations provide FDA
The recordkeeping requirements serve preventive and remedial purposes. The third-party disclosure requirements identify various blood and blood components and important properties of the product, demonstrate that the CGMP requirements have been met, and facilitate the tracing of a product back to its original source. The reporting requirements inform FDA of certain information that may require immediate corrective action.
Under the reporting requirements, § 606.170(b) (21 CFR 606.170(b)), in brief, requires that facilities notify FDA's Center for Biologics Evaluation and Research (CBER), as soon as possible after a complication of blood collection or transfusion is confirmed to be fatal. The collecting facility is required to report donor fatalities, and the compatibility testing facility is to report recipient fatalities. The regulation also requires the reporting facility to submit a written report of the investigation within 7 days after the fatality. In fiscal year 2016, FDA received 81 fatality reports.
Section 610.40(g)(2) (21 CFR 610.40(g)(2)) requires an establishment to obtain written approval from FDA to ship human blood or blood components for further manufacturing use prior to completion of testing for evidence of infection due to relevant transfusion-transmitted infections.
Section 610.41(b) (21 CFR 610.41(b)) allows for a previously deferred donor to subsequently be found to be an eligible donor of blood and blood components by a requalification method or process found acceptable for such purposes by FDA.
Section 610.40(h)(2)(ii)(A), in brief, requires an establishment to obtain written approval from FDA to use or ship human blood or blood components found to be reactive by a screening test for evidence of infection due to a relevant transfusion-transmitted infection(s) or collected from a donor deferred under § 610.41(a).
In addition, § 630.35(b) (21 CFR 630.35(b)) allows for a previously deferred donor, deferred for reasons other than § 610.41(a), to become requalified for donation by a method or process found acceptable for such purpose by FDA.
Under the third-party disclosure requirements, § 606.145(c) (21 CFR 606.145(c)) requires transfusion services to notify certain blood collection establishments concerning bacterial contamination of platelets and other additional information. In table 3, FDA estimates that for the approximately 4,961 transfusion services, there would be 1,400 total notifications per year to blood collection establishments (700 notifications that platelets are bacterially contaminated and 700 notifications per year concerning the identity or non-identity of the species of the contaminating organism).
Section 610.40(c)(1)(ii), in brief, requires that each donation dedicated to a single identified recipient be labeled as required under § 606.121 (21 CFR 606.121) and with a label containing the name and identifying information of the recipient. The information collection requirements under § 606.121 are part of usual and customary business practice.
Section 610.40(h)(2)(ii)(C) and (D), in brief, require an establishment to label certain reactive human blood and blood components with the appropriate screening test results for evidence of infection due to the identified relevant transfusion-transmitted infection(s), and, if they are intended for further manufacturing use into products, to include a statement on the label indicating the exempted use specifically approved by FDA. Also, § 610.40(h)(2)(vi) requires each donation of human blood or blood components, excluding Source Plasma, that tests reactive by a screening test for syphilis and is determined to be a biological false positive to be labeled with both test results.
Section 610.42(a) (21 CFR 610.42(a)) requires a warning statement “indicating that the product was manufactured from a donation found to be reactive by a screening test for evidence of infection due to the identified relevant transfusion-transmitted infection(s)” in the labeling for medical devices containing human blood or a blood component found to be reactive by a screening test for evidence of infection due to a relevant transfusion-transmitted infection(s) or syphilis.
In brief, §§ 610.46 and 610.47 (21 CFR 610.46 and 610.47) require blood collecting establishments to establish, maintain, and follow an appropriate system for performing HIV and HCV “lookback” when: (1) A donor tests reactive for evidence of HIV or HCV infection or (2) the collecting establishment becomes aware of other reliable test results or information indicating evidence of HIV or HCV infection (see §§ 610.46(a)(1) and 610.47(a)(1)). The requirement for “an appropriate system” requires the collecting establishment to design standard operating procedures (SOPs) to identify and quarantine all blood and blood components previously collected from a donor who later tests reactive for evidence of HIV or HCV infection, or when the collecting establishment is made aware of other reliable test results or information indicating evidence of HIV or HCV infection. Within 3 calendar days of the donor testing reactive by an HIV or HCV screening test or the collecting establishment becoming aware of other reliable test results or information, the collecting establishment must, among other things, notify consignees to quarantine all identified previously collected in-date blood and blood components (§§ 610.46(a)(1)(ii)(B) and 610.47(a)(1)(ii)(B)) and, within 45 days, notify the consignees of supplemental test results, or the results of a reactive screening test if there is no available supplemental test that is approved for such use by FDA (§§ 610.46(a)(3) and 610.47(a)(3)).
Consignees also must establish, maintain, and follow an appropriate system for performing HIV and HCV “lookback” when notified by the collecting establishment that they have received blood and blood components previously collected from donors who later tested reactive for evidence of HIV or HCV infection, or when the collecting establishment is made aware of other reliable test results or information indicating evidence of HIV or HCV infection in a donor (§§ 610.46(b) and 610.47(b)). This provision for a system requires the consignee to establish SOPs for, among other things, notifying transfusion recipients of blood and blood components, or the recipient's physician of record or legal representative, when such action is indicated by the results of the supplemental (additional, more specific) tests or a reactive screening test if there is no available supplemental test that is approved for such use by FDA, or if under an investigational new drug application (IND) or an investigational device exemption (IDE), is exempted for such use by FDA. The consignee must make reasonable attempts to perform the notification within 12 weeks of receipt of the supplemental test result or receipt of a reactive screening test result when there is no available supplemental test that is approved for such use by FDA, or if under an IND or IDE, is exempted for such use by FDA (§§ 610.46(b)(3) and 610.47(b)(3)). The burden for the recordkeeping requirements under §§ 610.46(a) and (b) and 610.47(a) and
Section 630.40(a) (21 CFR 630.40(a)) requires an establishment to make reasonable attempts to notify any donor who has been deferred as required by § 610.41(a), or who has been determined not to be eligible as a donor. Section 630.40(d)(1) requires an establishment to provide certain information to the referring physician of an autologous donor who is deferred based on the results of tests as described in § 610.41.
Under the recordkeeping requirements, § 606.100(b), in brief, requires that written SOPs be maintained for all steps to be followed in the collection, processing, compatibility testing, storage, and distribution of blood and blood components used for transfusion and further manufacturing purposes. Section 606.100(c) requires the review of all records pertinent to the lot or unit of blood prior to release or distribution. Any unexplained discrepancy or the failure of a lot or unit of final product to meet any of its specifications must be thoroughly investigated, and the investigation, including conclusions and followup, must be recorded.
In brief, § 606.110(a) (21 CFR 606.110(a)) provides that the use of plateletpheresis and leukapheresis procedures to obtain a product for a specific recipient may be at variance with the additional standards for that specific product if, among other things, the physician determines and documents that the donor's health permits plateletpheresis or leukapheresis. Section 606.110(b) requires establishments to request prior approval from CBER for plasmapheresis of donors who do not meet donor requirements. The information collection requirements for § 606.110(b) are approved under OMB control number 0910-0338 and, therefore, are not reflected in the tables of this document.
Section 606.151(e) (21 CFR 606.151(e)) requires that SOPs for compatibility testing include procedures to expedite transfusion in life-threatening emergencies; records of all such incidents must be maintained, including complete documentation justifying the emergency action, which must be signed by a physician.
Section 606.171 (21 CFR 606.171) requires establishments to establish and maintain procedures related to product deviations. The burden for the recordkeeping requirements under § 606.171 are included under § 606.100.
So that each significant step in the collection, processing, compatibility testing, storage, and distribution of each unit of blood and blood components can be clearly traced, § 606.160 (21 CFR 606.160) requires that legible and indelible contemporaneous records of each such step be made and maintained for no less than 10 years. Section 606.160(b)(1)(viii) requires records of the quarantine, notification, testing, and disposition performed under the HIV and HCV “lookback” provisions. Furthermore, § 606.160(b)(1)(x) requires a blood collection establishment to maintain records of notification of donors deferred or determined not to be eligible for donation, including appropriate followup. Section 606.160(b)(1)(xi) requires an establishment to maintain records of notification of the referring physician of a deferred autologous donor, including appropriate followup.
Section 606.165 (21 CFR 606.165), in brief, requires that distribution and receipt records be maintained to facilitate recalls, if necessary.
Section 606.170(a) requires records to be maintained of any reports of complaints of adverse reactions arising as a result of blood collection or transfusion. Each such report must be thoroughly investigated, and a written report, including conclusions and followup, must be prepared and maintained. Section 606.170(a) also requires that when an investigation determines that the product caused the transfusion reaction, copies of all such written reports must be forwarded to and maintained by the manufacturer or collecting facility.
Section 610.40(g)(1) requires an establishment to appropriately document a medical emergency for the release of human blood or blood components prior to completion of required testing.
Under § 630.15(a)(1)(ii)(B) (21 CFR 630.15(a)(1)(ii)(B)), FDA requires that for a dedicated donation based on the intended recipient's documented exceptional medical need, the responsible physician determines and documents that the health of the donor would not be adversely affected by donating.
Under § 630.20(c) (21 CFR 630.20(c)), a collection establishment may collect blood and blood components from a donor who is determined to be not eligible to donate under any provision of § 630.10(e) and (f) or § 630.15(a), if the donation is restricted for use solely by a specific transfusion recipient based on documented exceptional medical need and the responsible physician determines and documents that the donor's health permits the collection procedure, and that the donation presents no undue medical risk to the transfusion recipient.
In addition to the CGMP regulations in part 606, the regulations in 21 CFR part 630 that include requirements for blood and blood components intended for transfusion or further manufacturing use and in 21 CFR part 640 that require additional standards for certain blood and blood products are as follows: 21 CFR 630.5(b)(1)(i) and(d); 630.10(c)(1) and (2); 630.10(f)(2) and (4); 630.10(g)(2)(i); 630.15(a)(1)(ii)(A) and (B); 630.15(b)(2), (b)(7)(i) and (iii); 630.20(a) and (b); 640.21(e)(4); 640.25(b)(4) and (c)(1); 640.31(b); 640.33(b); 640.51(b); 640.53(b) and (c); 640.56(b) and (d); 640.65(b)(2)(i); 640.66; 640.71(b)(1); 640.72; 640.73; and 640.76(a) and (b). The information collection requirements and estimated burdens for these regulations are included in the part 606 burden estimates, as described in tables 1 and 2.
Respondents to this collection of information are licensed and unlicensed blood establishments that collect blood and blood components, including Source Plasma and Source Leukocytes, inspected by FDA, and transfusion services inspected by Centers for Medicare and Medicaid Services (CMS). Based on information received from CBER's database systems, there are approximately 569 licensed Source Plasma establishments and approximately 1,054 licensed blood collection establishments, for an estimated total of 1,623 (569 + 1,054) licensed blood collection establishments. Also, there are an estimated total of 680 unlicensed, registered blood collection establishments for an approximate total of 2,303 collection establishments (569 + 1,054 + 680 = 2,303 establishments). Of these establishments, approximately 901 perform plateletpheresis and leukopheresis. These establishments annually collect approximately 53.3 million units of Whole Blood and blood components, including Source Plasma and Source Leukocytes, and are required to follow FDA “lookback” procedures. In addition, there are another estimated 4,961 establishments that fall under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) (formerly referred to as facilities approved for Medicare reimbursement) that transfuse blood and blood components.
The following reporting, recordkeeping, and disclosure estimates are based on information provided by industry, CMS, and FDA experience. Based on information from industry, we estimate that there are approximately
FDA estimates that approximately 0.19 percent (21,000/10,794,000) of the 72,000 donations that are donated specifically for the use of an identified recipient would be tested under the dedicated donors' testing provisions in § 610.40(c)(1)(ii).
Under § 610.40(g)(2) and (h)(2)(ii)(A), Source Leukocytes, a licensed product that is used in the manufacture of interferon, which requires rapid preparation from blood, is currently shipped prior to completion of testing for evidence of relevant transfusion-transmitted infections. Shipments of Source Leukocytes are approved under a biologics license application and each shipment does not have to be reported to the Agency. Based on information from CBER's database system, FDA receives less than one application per year from manufacturers of Source Leukocytes. However, for calculation purposes, we are estimating one application annually.
According to CBER's database system, there are approximately 15 licensed manufacturers that ship known reactive human blood or blood components under § 610.40(h)(2)(ii)(C) and (D). FDA estimates that each manufacturer would ship an estimated 1 unit of human blood or blood components per month (12 per year) that would require two labels; one as reactive for the appropriate screening test under § 610.40(h)(2)(ii)(C), and the other stating the exempted use specifically approved by FDA under § 610.40(h)(2)(ii)(D).
Based on information received from industry, we estimate that approximately 7,544 donations will test reactive by a screening test for syphilis and be determined to be biological false positives by additional testing annually. These units would be labeled according to § 610.40(h)(2)(vi).
Human blood or a blood component with a reactive screening test, as a component of a medical device, is an integral part of the medical device,
FDA estimates that approximately 3,021 repeat donors will test reactive on a screening test for HIV. We also estimate that an average of three components was made from each donation. Under § 610.46(a)(1)(ii)(B) and (a)(3), this estimate results in 9,063 (3,021 × 3) notifications of the HIV screening test results to consignees by collecting establishments for the purpose of quarantining affected blood and blood components, and another 9,063 (3,021 × 3) notifications to consignees of subsequent test results.
We estimate that approximately 4,961 consignees will be required under § 610.46(b)(3) to notify transfusion recipients, their legal representatives, or physicians of record an average of 0.35 times per year resulting in a total number of 1,755 (585 confirmed positive repeat donors × 3) notifications. Also under § 610.46(b)(3), we estimate and include the time to gather test results and records for each recipient and to accommodate multiple attempts to contact the recipient.
Furthermore, we estimate that approximately 6,799 repeat donors per year would test reactive for antibody to HCV. Under § 610.47(a)(1)(ii)(B) and (a)(3), collecting establishments would notify the consignee two times for each of the 20,397 (6,799 × 3 components) components prepared from these donations, once for quarantine purposes and again with additional HCV test results for a total of 40,794 (20,397 × 2) notifications as an annual ongoing burden. Under § 610.47(b)(3), we estimate that approximately 4,961 consignees would notify approximately 2,050 recipients or their physicians of record annually.
Based on industry estimates, approximately 14.3 percent of approximately 9 million potential donors (1,287,000 donors) who come to donate annually are determined not to be eligible for donation prior to collection because of failure to satisfy eligibility criteria. It is the usual and customary business practice of approximately 1,734 (1,054 + 680) blood collecting establishments to notify onsite and to explain why the donor is determined not to be suitable for donating. Based on such available information, we estimate that two-thirds (1,156) of the 1,734 blood collecting establishments provided onsite additional information and counseling to a donor determined not to be eligible for donation as usual and customary business practice. Consequently, we estimate that only approximately one-third, or 578 of the 1,734 blood collecting establishments would need to provide, under § 630.40(a), additional information and onsite counseling to the estimated 429,000 (one-third of approximately 1,287,000) ineligible donors.
It is estimated that another 4.5 percent of 10 million potential donors (450,000 donors) are deferred annually based on test results. We estimate that approximately 95 percent of the establishments that collect 99 percent of the blood and blood components notify donors who have reactive test results for HIV, hepatitis B virus, HCV, human T-lymphotropic virus, and syphilis as usual and customary business practice. Consequently, 5 percent of the 1,623 licensed establishments (81) collecting 1 percent (4,050) of the deferred donors (405,000) would notify donors under § 630.40(a).
As part of usual and customary business practice, collecting establishments notify an autologous donor's referring physician of reactive test results obtained during the donation process required under § 630.40(d)(1). However, we estimate that approximately 5 percent of the 1,054 blood collection establishments (53) may not notify the referring physicians of the estimated 2 percent of 31,364 autologous donors with the initial reactive test results (627) as their usual and customary business practice.
The recordkeeping chart reflects the estimate that approximately 95 percent of the recordkeepers, which collect 99 percent of the blood supply, have developed SOPs as part of their customary and usual business practice. Establishments may minimize burdens associated with CGMP and related regulations by using model standards developed by industries' accreditation organizations. These accreditation organizations represent almost all registered blood establishments.
Under § 606.160(b)(1)(x), we estimate the total annual records based on the approximately 1,287,000 donors determined not to be eligible to donate and each of the estimated 1,692,000 (1,287,000 + 405,000) donors deferred based on reactive test results for
Under § 610.41(b), FDA estimates that there would be 25 submissions for requalification of donors. In addition, FDA estimates that there would be only three notifications for requalification of donors under § 630.35(b). FDA also estimates the average time for each submission.
FDA permits the shipment of untested or incompletely tested human blood or blood components in rare medical emergencies and when appropriately documented (§ 610.40(g)(1)). We estimate the recordkeeping under § 610.40(g)(1) to be minimal with one or fewer occurrences per year. The reporting of test results to the consignee in § 610.40(g) is part of the usual and customary business practice of blood establishments.
In the
The average burden per response (hours) and average burden per recordkeeping (hours) are based on estimates received from industry or FDA experience with similar reporting or recordkeeping requirements.
FDA estimates the burden of this collection of information as follows:
The burden for this information collection has changed since the last OMB approval. Because of a slight decrease in the number of blood establishments during the last 3 years, FDA has decreased our recordkeeping and third-party disclosure burden estimates.
Health Resources and Service Administration (HRSA), Department of Health and Human Services (HHS).
Notice of Federal Advisory Committee meeting.
In accordance with the Federal Advisory Committee Act, this notice announces that the Advisory Committee on Training in Primary Care Medicine and Dentistry (ACTPCMD) will hold a public meeting.
Thursday, May 3, 2018, from 8:30 a.m. to 5:00 p.m. and Friday, May 4, 2018, from 8:30 a.m. to 2:00 p.m. ET.
The address for the meeting is 5600 Fishers Lane, Rockville, Maryland 20857, Room 5E29. The conference call-in number: 1-800-857-9729 and Passcode: 1318150. The webinar link is
Anyone requesting information regarding the ACTPCMD should contact Dr. Kennita R. Carter, Designated Federal Official (DFO), Division of Medicine and Dentistry, Bureau of Health Workforce, HRSA, in one of three ways: (1) Send a request to the following address: Dr. Kennita R. Carter, DFO, Division of Medicine and Dentistry, HRSA, 5600 Fishers Lane, Room 15N-116, Rockville, MD 20857; (2) call 301-945-3505; or (3) send an email to
ACTPCMD provides advice and recommendations to the Secretary of the Department of Health and Human Services on policy, program development, and other matters of significance concerning the activities under section 747 of Title VII of the Public Health Service Act (PHSA). ACTPCMD prepares an annual report describing the activities of the Committee, including findings and recommendations made by the Committee concerning the activities under section 747, as well as training programs in oral health and dentistry. The annual report is submitted to the Secretary and ranking members of the Senate Committee on Health, Education, Labor and Pensions, and the House of Representatives Committee on Energy and Commerce. The Committee also develops, publishes, and implements performance measures and guidelines for longitudinal evaluations of programs authorized under Title VII, Part C, of the PHSA, and recommends appropriation levels for programs under this Part.
During the May 3-4, 2018, meeting, ACTPCMD will review the impact of the Title VII, Section 747 and oral health training programs, and make recommendations on funding and appropriation levels. In addition, the Committee will identify its strategic priorities for the coming year, and discuss issues related to pending Committee reports on the integration of behavioral health into primary care and oral health training, and clinical trainee and faculty well-being and resilience. Information about ACTPCMD and the agenda for this meeting is located on the ACTPCMD website at
Members of the public will have the opportunity to provide comments. Public participants may submit written statements in advance of the scheduled meeting. Oral comments will be honored in the order they are requested and may be limited as time allows. Requests to make oral comments or provide written comments to the ACTPCMD should be sent to Dr. Carter, DFO, using the contact information above at least three business days prior to the meeting.
The building at 5600 Fishers Lane, Rockville, MD 20857, requires a security screening on entry. To facilitate access to the building, please contact Dr. Carter at the contact information listed above. Individuals who plan to attend and need special assistance, such as sign language interpretation or other reasonable accommodations, should notify Dr. Carter at the address and phone number listed above at least 10 days prior to the meeting.
Pursuant to the Federal Advisory Committee Act, the Department of Health and Human Services (HHS) announces the following advisory committee meeting.
The times and topics are subject to change. Please refer to the posted agenda for any updates.
Should you require reasonable accommodation, please contact the CDC Office of Equal Employment Opportunity on (770) 488-3210 as soon as possible.
Pursuant to the Federal Advisory Committee Act, the Department of Health and Human Services (HHS) announces the following advisory committee meeting.
NCVHS is working on the development of a standards update and adoption roadmap (the predictability roadmap), in collaboration with industry stakeholders and the Standards Development Organizations (SDOs). The purpose of this roadmap is to improve the predictability of the update and adoption process of the standards and operating rules. It is the intent of the collaboration effort to identify the barriers to updating and adopting standards and make constructive, actionable recommendations for all parties, so that covered entities can more effectively conduct their business, operational and technical strategic planning.
NCVHS held a visioning exercise with the Standards Development Organizations (SDOs) in August 2017, and developed a set of draft action steps and recommendations. The next step towards finalizing recommendations for the Secretary, is to convene a group of Chief Information Officers (CIOs) who work with the standards and operating rules as end users, with health care leaders from various fields of health care technology. The CIOs and health care innovators will exchange information based on their experience and expertise. The CIOs will discuss their changing business and technology needs specifically as these pertain to the standards that have been adopted under HIPAA such as claims, eligibility, referrals and authorizations. Some individuals will share their experience using the standards day to day, and to increase efficiencies in their organizations. Other participants will share their experience implementing or seeing innovative technology being used for the exchange of electronic health care information.
During the second part of the forum, the group will engage in an open discussion about the roadmap themes and develop additional action items and recommendations for the Secretary. The roadmap themes and their problem statements are listed below:
1. Standards Development and update process. Frequency of updates to standards and operating rules is not aligned with industry business and technical changes and does not enable covered entities, trading partners, or business associates to take advantage of developments in technology.
2. Governance, or oversight of the standards review process (currently the Designated Standards Maintenance Organization or DSMO process established through regulation). Current coordinating body (
3. Federal regulatory process to adopt new versions of standards. The Federal process for adoption of standards and operating rules is lengthy, of unpredictable duration and contains numerous checks and balances that duplicate similar processes within the standards development organizations. The lack of predictability and timeliness jeopardizes the smooth adoption and uptake of standards and operating rules once they are developed and published by the SDO.
4. Data harmonization. The lack of data cohesion due to inconsistencies in data dictionaries and data elements across SDOs jeopardizes interoperability.
5. Inclusion of non-covered entities under HIPAA. Covered entities include providers, health plans and health care clearinghouses. Vendors and other business associates are not covered entities but often play a role in the exchange and/or processing of the adopted standards. The Federal government is limited in its authority over non-covered entities. This impacts the use of standards in a variety of ways, from costs to actual utilization.
The times and topics are subject to change. Please refer to the posted agenda for any updates.
Should you require reasonable accommodation, please contact the CDC Office of Equal Employment Opportunity on (770) 488-3210 as soon as possible.
The Indian Health Service (IHS) Office of Tribal Self-Governance (OTSG) is accepting applications for Negotiation Cooperative Agreements for the Tribal Self-Governance Program (TSGP). This program is authorized under: Title V of the Indian Self-Determination and Education Assistance Act (ISDEAA), 25 U.S.C. 5383(e). This program is described in the Catalog of Federal Domestic Assistance (CFDA) under 93.444.
The TSGP is more than an IHS program; it is an expression of the Government-to-Government relationship between the United States (U.S.) and Indian Tribes. Through the TSGP, Tribes negotiate with the IHS to assume Programs, Services, Functions, and Activities (PSFAs), or portions thereof, which gives Tribes the authority to manage and tailor health care programs in a manner that best fits the needs of their communities.
Participation in the TSGP affords Tribes the most flexibility to tailor health care PSFAs and is one of three ways that Tribes can choose to obtain health care from the Federal Government for their citizens. Specifically, Tribes can choose to: (1) Receive health care services directly from the IHS, (2) contract with the IHS to administer individual programs and services the IHS would otherwise provide (referred to as Title I Self-Determination Contracting, and (3) compact with the IHS to assume control over health care programs the IHS would otherwise provide (referred to as Title V Self-Governance Compacting or the TSGP). These options are not exclusive and Tribes may choose to combine options based on their individual needs and circumstances.
The TSGP is a tribally driven initiative, and strong Federal-Tribal partnerships are essential to the program's success. The IHS established the OTSG to implement the Tribal Self-Governance authorities under the ISDEAA. The primary OTSG functions are to: (1) Serve as the primary liaison and advocate for Tribes participating in the TSGP, (2) develop, direct, and implement TSGP policies and procedures, (3) provide information and technical assistance to Self-Governance Tribes, and (4) advise the IHS Director on compliance with TSGP policies, regulations, and guidelines. Each IHS Area has an Agency Lead Negotiator (ALN), designated by the IHS Director to act on his or her behalf, who has authority to negotiate Self-Governance Compacts and Funding Agreements (FA). Prospective Tribes interested in participating in the TSGP should contact their respective ALN to begin the Self-Governance planning process. Also, Tribes currently participating in the TSGP, who are interested in expanding existing or adding new PSFAs, should also contact their respective ALN to discuss the best methods for expanding or adding new PSFAs.
The purpose of this Negotiation Cooperative Agreement is to provide Tribes with resources to help defray the costs associated with preparing for and engaging in TSGP negotiations. TSGP
The negotiations process has four major stages, including: (1) Planning, (2) pre-negotiations, (3) negotiations, and (4) post-negotiations. Title V of the ISDEAA requires that a Tribe or Tribal organization complete a planning phase to the satisfaction of the Tribe. The planning phase must include legal and budgetary research and internal Tribal Government planning and organizational preparation relating to the administration of health care programs.
During pre-negotiations, the Tribal and Federal negotiation teams review and discuss issues identified during the planning phase. Pre-negotiations provide an opportunity for the Tribe and the IHS to identify and discuss issues directly related to the Tribe's Compact, FA and Tribal shares. They may take the form of a formal meeting or a series of informal meetings or conference calls.
In advance of final negotiations, the Tribe should work with the IHS to secure the following: (1) Program titles and descriptions, (2) financial tables and information, (3) information related to the identification and justification of residuals, and (4) the basis for determining Tribal shares (distribution formula). The Tribe may also wish to discuss financial materials that show estimated funding for next year, and the increases or decreases in funding it may receive in the current year, as well as the basis for those changes.
Having reviewed the draft documents and funding tables, at final negotiations both negotiation teams work together in good faith to determine and agree upon the terms and provisions of the Tribe's Compact and FA. Negotiations are not an allocation process; they provide an opportunity to mutually review and discuss budget and program issues. As issues arise, both negotiations teams work through the issues to reach agreement on the final documents.
There are various entities involved throughout the negotiations process. For example, a Tribal government selects its representative(s) for negotiations and the Tribal negotiations team, which may include a Tribal leader from the governing body, a Tribal health director, technical and program staff, legal counsel, and other consultants. Regardless of the composition of the Tribal team, Tribal representatives must have decision making authority from the Tribal governing body to successfully negotiate and agree to the provisions within the agreements. The Federal negotiations team is led by the ALN and may include area and headquarters staff, including staff from the OTSG, the Office of Finance and Accounting, and the Office of the General Counsel. The ALN is the only member of the Federal negotiations team with delegated authority to negotiate on behalf of the IHS Director. The ALN is the designated official that provides Tribes with Self-Governance information, assists Tribes in planning, organizes meetings between the Tribe and the IHS, and coordinates the Agency's response to Tribal questions during the negotiations process. The ALN role requires detailed knowledge of the IHS, awareness of current policy and practice, and understanding of the rights and authorities available to a Tribe under Title V of the ISDEAA.
In post-negotiations, after the Compact, FA and all negotiations are complete, the documents are signed by the authorizing Tribal official and submitted to the ALN who reviews the final package to ensure each document accurately reflects what was negotiated. Once the ALN completes this review, then the final package is submitted to the OTSG to be prepared for the IHS Director's signature, provided that no outstanding issues delay or prevent signature. After the Compact and FA have been signed by both parties, they become legally binding and enforceable agreements. A signed Compact and FA are necessary for the payment process to begin. The negotiating Tribe then becomes a “Self-Governance Tribe” and a participant in the TSGP.
Acquiring a Negotiation Cooperative Agreement is not a prerequisite to enter the TSGP. A Tribe may use other resources to develop and negotiate its Compact and FA.
There is limited competition under this announcement because the authorizing legislation restricts eligibility to Tribes that meet specific criteria identified in Section III. Eligibility Criteria, 1. Eligibility, A.
Cooperative Agreement.
The total amount of funding identified for the current fiscal year (FY) 2018 is approximately $240,000. Individual award amounts are anticipated to be $48,000. The amount of funding available for awards issued under this announcement are subject to the availability of appropriations and budgetary priorities of the Agency. The IHS is under no obligation to make awards that are selected for funding under this announcement.
Approximately five awards will be issued under this program announcement.
The period of performance is for one year and runs from July 15, 2018, to July 14, 2019.
Cooperative agreements awarded by the Department of Health and Human Services (HHS) are administered under the same policies as a grant. However, the IHS is required to have substantial programmatic involvement in the project during the entire award segment. Below is a detailed description of the level of involvement required for both the IHS and the grantee. The IHS will be responsible for activities listed under section A and the grantee will be responsible for activities listed under section B as stated:
(1) Provide descriptions of PSFAs and associated funding at all organizational levels (Service Unit, Area, and Headquarters), including funding formulas and methodologies related to determining Tribal shares.
(2) Meet with Negotiation Cooperative Agreement recipients to provide program information and discuss methods currently used to manage and deliver health care.
(3) Identify and provide statutes, regulations, and policies that provide authority for administering IHS programs.
(4) Provide technical assistance on the IHS budget, Tribal shares, and other topics as needed.
(1) Determine the PSFAs that will be negotiated into the Tribe's Compact and FA. Prepare and discuss each Program, Service Function and Activity in comparison to the current level of services provided so that an informed decision can be made on new or expanded program assumption.
(2) Identify Tribal shares associated with the PSFAs that will be included in the FA.
(3) Develop the terms and conditions that will be set for in both the Compact and FA to submit to the ALN prior to negotiations.
To be eligible for the New Limited Competition Negotiation Cooperative Agreement under this announcement, an applicant must:
(A) Be an “Indian Tribe” as defined in 25 U.S.C. 5304(e); a “Tribal Organization” as defined in 25 U.S.C. 5304(l); or an “Inter-Tribal Consortium: as defined at 42 CFR 137.10. However, Alaska Native Villages or Alaska Native Village Corporations are not eligible if they are located within the area served by an Alaska Native regional health entity. See Consolidated Appropriations Act, 2014, Public Law 113-76. By statute, the Native Village of Eyak, Eastern Aleutian Tribes, and the Council for Athabascan Tribal Governments have also been deemed Alaska Native regional health entities and therefore are eligible to apply. Those Alaska Tribes not represented by a Self-Governance Tribal consortium FA within their area may still be considered to participate in the TSGP.
(B) Submit Tribal resolution(s) from the appropriate governing body of each Indian Tribe to be served by the ISDEAA Compact authorizing the submission of the Negotiation Cooperative Agreement. Tribal consortia applying for a TSGP Negotiation Cooperative Agreement shall submit Tribal Council resolutions from each Tribe in the consortium. Tribal resolutions can be attached to the electronic online application.
(C) Demonstrate for three fiscal years, financial stability and financial management capability. The Indian Tribe must provide evidence that, for the three fiscal years prior to requesting participation in the TSGP, the Indian Tribe has had no uncorrected significant and material audit exceptions in the required annual audit of the Indian Tribe's Self-Determination Contracts or Self-Governance FAs with any Federal Agency.
For Tribes or Tribal organizations (T/TO) that expended $750,000 or more ($500,000 for fiscal years ending after December 31, 2003) in Federal awards, the OTSG shall retrieve the audits directly from the Federal Audit Clearinghouse.
For T/TO that expended less than $750,000 ($500,000 for fiscal years ending after December 31, 2003) in Federal awards, the T/TO must provide evidence of the program review correspondence from IHS or Bureau of Indian Affairs officials.
Meeting the eligibility criteria for a Negotiation Cooperative Agreement does not mean that a Tribe/Tribal Organization is eligible for participation in the IHS TSGP under Title V of the ISDEAA.
Please refer to Section IV.2 (Application and Submission Information/Subsection 2, Content and Form of Application Submission) for additional proof of applicant status documents required, such as Tribal resolutions, proof of non-profit status, etc.
The IHS does not require matching funds or cost sharing for grants or cooperative agreements.
If application budgets exceed the highest dollar amount outlined under the “Estimated Funds Available” section within this funding announcement, the application will be considered ineligible and will not be reviewed for further consideration. If deemed ineligible, the IHS will not return the application. The applicant will be notified by email by the Division of Grants Management (DGM) of this decision.
Submit Tribal resolution(s) from the appropriate governing body of the Indian Tribe to be served by the ISDEAA Compact authorizing the submission of a Negotiation Cooperative Agreement application. Tribal consortia applying for a TSGP Negotiation Cooperative Agreement shall submit Tribal Council resolutions from each Tribe in the consortium. Tribal resolutions can be attached to the electronic online application.
An official signed Tribal resolution must be received by the DGM prior to a Notice of Award (NoA) being issued to any applicant selected for funding. However, if an official signed Tribal resolution cannot be submitted with the electronic application submission prior to the official application deadline date, then a draft Tribal resolution is acceptable and must be submitted by the deadline in order for the application to be considered complete and eligible for review. The draft Tribal resolution is not in lieu of the required signed resolution, but is acceptable until a signed resolution is received. If an official signed Tribal resolution is not
An applicant submitting Tribal resolution(s) after the initial application submission due date is required to ensure the information was received by the IHS by obtaining documentation confirming delivery (
The application package and detailed instructions for this announcement can be found at:
Questions regarding the electronic application process may be directed to Mr. Paul Gettys at (301) 443-2114 or (301) 443-5204.
The applicant must include the project narrative as an attachment to the application package. Mandatory documents for all applicants include:
• Table of contents.
• Abstract (one page) summarizing the project.
• Application forms:
○ SF-424, Application for Federal Assistance.
○ SF-424A, Budget Information—Non-Construction Programs.
○ SF-424B, Assurances—Non-Construction Programs.
Line Item Budget and Narrative (must be single-spaced and not exceed five pages).
• Project Narrative (must be single-spaced and not exceed ten pages).
○ Background information on the organization.
○ Proposed scope of work, objectives, and activities that provide a description of what will be accomplished, including a one-page Timeframe Chart.
• Tribal Resolution(s).
• Letters of Support from organization's Board of Directors.
• 501(c)(3) Certificate (if applicable).
• Biographical sketches for all Key Personnel.
• Contractor/Consultant resumes or qualifications and scope of work.
• Disclosure of Lobbying Activities (SF-LLL).
• Certification Regarding Lobbying (GG-Lobbying Form).
• Copy of current Negotiated Indirect Cost rate (IDC) agreement (required in order to receive IDC).
• Organizational Chart (optional).
• Documentation of current Office of Management and Budget (OMB) Financial Audit.
Acceptable forms of documentation include:
○ Email confirmation from Federal Audit Clearinghouse (FAC) that audits were submitted; or
○ Face sheets from audit reports. These can be found on the FAC website:
All Federal wide public policies apply to IHS grants and cooperative agreements with exception of the Discrimination Policy.
A.
Be sure to succinctly answer all questions listed under the evaluation criteria (refer to Section V.1, Evaluation criteria in this announcement) and place all responses and required information in the correct section (noted below), or they will not be considered or scored. These narratives will assist the Objective Review Committee (ORC) in becoming familiar with the applicant's activities and accomplishments prior to this possible cooperative agreement award. If the narrative exceeds the page limit, then only the first ten pages will be reviewed. The ten page limit for the narrative does not include the work plan, standard forms, Tribal resolutions, table of contents, budget, budget justifications, narratives, and/or other appendix items.
There are three parts to the narrative: Part A—Program Information; Part B—Program Planning and Evaluation; and Part C—Program Report. See below for additional details about what must be included in the narrative.
The page limitations below are for each narrative and budget submitted.
Demonstrate that the Tribe has conducted previous Self-Governance planning activities by clearly stating the results of what was learned during the planning process. Explain how the Tribe has determined it has the: (1) Knowledge and expertise to assume or expand PSFAs, and (2) the administrative infrastructure to support the assumption of PSFAs. Identify the need for assistance and how the Negotiation Cooperative Agreement would benefit the health activities the Tribe is preparing to assume or expand.
State in measureable terms
(A) Determine the PSFAs that will be negotiated into the Tribe's Compact and FA. Prepare and discuss each Program, Service, Function, and Activity in comparison to the current level of services provided so that an informed decision can be made on new or expanded program assumption.
(B) Identify Tribal shares associated with the PSFAs that will be included in the FA.
(C) Develop the terms and conditions that will be set forth in both the Compact and FA to submit to the ALN prior to negotiations.
(D) Describe fully and clearly how the Tribe's proposal will result in an improved approach to managing the PSFAs to be assumed or expanded. Include how the Tribe plans to demonstrate improved health services to the community and incorporate the proposed timelines for negotiations.
Describe the organizational structure of the Tribe and its ability to manage the proposed project. Include resumes or position descriptions of key staff showing requisite experience and expertise. If applicable, include resumes and scope of work for consultants that demonstrate experience and expertise relevant to the project.
Describe fully and clearly how the improvements that will be made by the Tribe to manage the health care system and identify the anticipated or expected benefits for the Tribe. Define the criteria to be used to evaluate objectives associated with the project.
This narrative must include a line item budget with a narrative justification for all expenditures identifying reasonable allowable, allocable costs necessary to accomplish the goals and objectives as outlined in the project narrative. Budget should match the scope of work described in the project narrative.
Applications must be submitted electronically through
If technical challenges arise and assistance is required with the electronic application process, contact
Executive Order 12372 requiring intergovernmental review is not applicable to this program.
• Pre-award costs are not allowable.
• The available funds are inclusive of direct and appropriate indirect costs.
• Tribes can apply for a Planning Cooperative Agreement and a Negotiation Cooperative Agreement in the same cycle, so long as the project proposals are different for each application. Tribes cannot apply for both the Planning Cooperative Agreement and the Negotiation Cooperative Agreement within the same grant cycle with the same proposed project.
• Only one Negotiation grant/cooperative agreement will be awarded per applicant per grant cycle under this announcement.
• IHS will not acknowledge receipt of applications.
All applications must be submitted electronically. Please use the
If the applicant needs to submit a paper application instead of submitting electronically through
Once the waiver request has been approved, the applicant will receive a confirmation of approval email containing submission instructions and the mailing address to submit the application. A copy of the written approval must be submitted along with the hardcopy of the application that is mailed to DGM. Paper applications that are submitted without a copy of the signed waiver from the Director of the DGM will not be reviewed or considered for funding. The applicant will be notified via email of this decision by the Grants Management Officer of the DGM. Paper applications must be received by the DGM no later than 5:00 p.m., EDT, on the Application Deadline Date listed in the Key Dates section on page one of this announcement. Late applications will not be accepted for processing or considered for funding. Applicants that do not adhere to the timelines for System for Award Management (SAM) and/or
Please be aware of the following:
• Please search for the application package in
• If you experience technical challenges while submitting your application electronically, please contact
• Upon contacting
• Applicants are strongly encouraged not to wait until the deadline date to begin the application process through
• Please use the optional attachment feature in
• All applicants must comply with any page limitation requirements described in this funding announcement.
• After electronically submitting the application, the applicant will receive an automatic acknowledgment from
• Email applications will not be accepted under this announcement.
All IHS applicants and grantee organizations are required to obtain a DUNS number and maintain an active registration in the SAM database. The DUNS number is a unique 9-digit identification number provided by D&B which uniquely identifies each entity. The DUNS number is site specific; therefore, each distinct performance site
All HHS recipients are required by the Federal Funding Accountability and Transparency Act of 2006, as amended (“Transparency Act”), to report information on sub-awards. Accordingly, all IHS grantees must notify potential first-tier sub-recipients that no entity may receive a first-tier sub-award unless the entity has provided its DUNS number to the prime grantee organization. This requirement ensures the use of a universal identifier to enhance the quality of information available to the public pursuant to the Transparency Act.
Organizations that were not registered with Central Contractor Registration and have not registered with SAM will need to obtain a DUNS number first and then access the SAM online registration through the SAM home page at:
Additional information on implementing the Transparency Act, including the specific requirements for DUNS and SAM, can be found on the IHS Grants Management, Grants Policy website:
The instructions for preparing the application narrative also constitute the evaluation criteria for reviewing and scoring the application. Weights assigned to each section are noted in parentheses. The ten page narrative section should be written in a manner that is clear to outside reviewers unfamiliar with prior related activities of the applicant. It should be well organized, succinct, and contain all information necessary for reviewers to understand the project fully. Points will be assigned to each evaluation criteria adding up to a total of 100 points. A minimum score of 60 points is required for funding. Points are assigned as follows:
Demonstrate that the Tribe has conducted previous Self-Governance planning activities by clearly stating the results of what was learned during the planning process. Explain how the Tribe has determined it has the: (1) Knowledge and expertise to assume or expand PSFAs, and (2) the administrative infrastructure to support the assumption of PSFAs. Identify the need for assistance and how the Negotiation Cooperative Agreement would benefit the health activities the Tribe is preparing to assume or expand.
State in measurable terms the objectives and appropriate activities to achieve the following Planning Cooperative Agreement recipient award activities:
(1) Determine the PSFAs that will be negotiated into the Tribe's Compact and FA. Prepare and discuss each Program, Service, Function and Activity in comparison to the level of services provided so that an informed decision can be made on new or expanded program assumption.
(2) Identify Tribal shares associated with the PSFAs that will be included in the FA.
(3) Develop the terms and conditions that will be set forth in both the Compact and FA to submit to the ALN prior to negotiations. Clearly describe how the Tribe's proposal will result in an improved approach to managing the PSFAs to be assumed or expanded. Include how the Tribe plans to demonstrate improved health care services to the community and incorporate the proposed timelines for negotiations.
Describe fully the improvements that will be made by the Tribe to manage the health care system and identify the anticipated or expected benefits for the Tribe. Define the criteria to be used to evaluate objectives associated with the project.
Describe the organizational structure of the Tribe and its ability to manage the proposed project. Include resumes or position descriptions of key staff showing requisite experience and expertise. If applicable, include resumes and scope of work for consultants that demonstrate experience and expertise relevant to the project.
Submit a budget with a narrative describing the budget request and matching the scope of work described in the project narrative. Justify all expenditures identifying reasonable and allowable costs necessary to accomplish the goals and objectives as outlined in the project narrative.
Additional documents can be uploaded as Appendix Items in
• Work plan, logic model and/or time line for proposed objectives.
• Position descriptions for key staff.
• Resumes of key staff that reflect current duties.
• Consultant or contractor proposed scope of work and letter of commitment (if applicable).
• Current Indirect Cost Agreement.
• Organizational chart.
• Map of area identifying project location(s).
• Additional documents to support narrative (
Each application will be prescreened by the DGM staff for eligibility and completeness as outlined in the funding announcement. Applications that meet the eligibility criteria shall be reviewed for merit by the ORC based on evaluation criteria in this funding announcement. The ORC could be composed of both Tribal and Federal reviewers appointed by the IHS Program to review and make recommendations on these applications. The technical review process ensures selection of quality projects in a national competition for limited funding. Incomplete applications and applications that are non-responsive to the eligibility criteria will not be referred to the ORC. The applicant will be notified via email of this decision by the Grants Management Officer of the DGM. Applicants will be notified by DGM, via email, to outline minor missing components (
To obtain a minimum score for funding by the ORC, applicants must address all program requirements and provide all required documentation.
The NoA is a legally binding document signed by the Grants Management Officer and serves as the official notification of the grant award. The NoA will be initiated by the DGM in our grant system, GrantSolutions (
Applicants who received a score less than the recommended funding level for approval, 60 and were deemed to be disapproved by the ORC, will receive an Executive Summary Statement from the OTSG within 30 days of the conclusion of the ORC outlining the strengths and weaknesses of their application. The summary statement will be sent to the Authorized Organizational Representative that is identified on the face page (SF-424) of the application. The OTSG will also provide additional contact information as needed to address questions and concerns as well as provide technical assistance if desired.
Approved but unfunded applicants that met the minimum scoring range and were deemed by the ORC to be “Approved,” but were not funded due to lack of funding, will have their applications held by DGM for a period of one year. If additional funding becomes available during the course of FY 2018 the approved but unfunded application may be re-considered by the OTSG for possible funding. The applicant will also receive an Executive Summary Statement from the OTSG within 30 days of the conclusion of the ORC.
Any correspondence other than the official NoA signed by an IHS grants management official announcing to the project director that an award has been made to their organization is not an authorization to implement their program on behalf of the IHS.
Cooperative agreements are administered in accordance with the following regulations and policies:
A. The criteria as outlined in this program announcement.
B. Administrative Regulations for Grants:
• Uniform Administrative Requirements for HHS Awards, located at 45 CFR part 75, located on the U.S. Government Publishing Office website at:
C. Grants Policy:
• HHS Grants Policy Statement, Revised 01/07, located at:
D. Cost Principles:
• Uniform Administrative Requirements for HHS Awards, “Cost Principles,” located at 45 CFR part 75, subpart E.
E. Audit Requirements:
• Uniform Administrative Requirements for HHS Awards, “Audit Requirements,” located at 45 CFR part 75, subpart F.
This section applies to all grant recipients that request reimbursement of indirect costs (IDC) in their grant application. In accordance with HHS Grants Policy Statement, Part II-27, IHS requires applicants to obtain a current IDC rate agreement prior to award. The rate agreement must be prepared in accordance with the applicable cost principles and guidance as provided by the cognizant agency or office. A current rate covers the applicable grant activities under the current award's budget period. If the current rate is not on file with the DGM at the time of award, the IDC portion of the budget will be restricted. The restrictions remain in place until the current rate is provided to the DGM.
Generally, IDC rates for IHS grantees are negotiated with the Division of Cost Allocation (DCA)
The grantee must submit required reports consistent with the applicable deadlines. Failure to submit required reports within the time allowed may result in suspension or termination of an active grant, withholding of additional awards for the project, or other enforcement actions such as withholding of payments or converting to the reimbursement method of payment. Continued failure to submit required reports may result in one or both of the following: (1) The imposition of special award provisions; and (2) the non-funding or non-award of other eligible projects or activities. This requirement applies whether the delinquency is attributable to the failure of the grantee organization or the individual responsible for preparation of the reports. Per DGM policy, all reports are required to be submitted electronically by attaching them as a “Grant Note” in GrantSolutions. Personnel responsible for submitting reports will be required to obtain a login and password for GrantSolutions. Please see the Agency Contacts list in section VII for the systems contact information.
The reporting requirements for this program are noted below.
Program progress reports are required semi-annually. These reports must include a brief comparison of actual accomplishments to the goals established for the six month period, a summary of progress to date or, if applicable, provide sound justification for the lack of progress, and other pertinent information as required by the program office. A final report must be submitted within 90 days of expiration of the budget or period of performance.
Federal Financial Report (FFR or SF-425), Cash Transaction Reports are due 30 days after the close of every calendar quarter to the Payment Management Services, HHS at:
Grantees are responsible and accountable for accurate information being reported on all required reports: The Progress Reports and Federal Financial Report.
This award may be subject to the Transparency Act sub-award and executive compensation reporting requirements of 2 CFR part 170.
The Transparency Act requires the OMB to establish a single searchable
IHS has implemented a Term of Award into all IHS Standard Terms and Conditions, NoAs and funding announcements regarding the FSRS reporting requirement. This IHS Term of Award is applicable to all IHS grant and cooperative agreements issued on or after October 1, 2010, with a $25,000 sub-award obligation dollar threshold met for any specific reporting period. Additionally, all new (discretionary) IHS awards (where the period of performance is made up of more than one budget period) and where: (1) The period of performance start date was October 1, 2010 or after, and (2) the primary awardee will have a $25,000 sub-award obligation dollar threshold during any specific reporting period will be required to address the FSRS reporting.
For the full IHS award term implementing this requirement and additional award applicability information, visit the DGM Grants Policy website at:
Recipients of Federal financial assistance (FFA) from HHS must administer their programs in compliance with Federal civil rights law. This means that recipients of HHS funds must ensure equal access to their programs without regard to a person's race, color, national origin, disability, age and, in some circumstances, sex and religion. This includes ensuring your programs are accessible to persons with limited English proficiency. HHS provides guidance to recipients of FFA on meeting their legal obligation to take reasonable steps to provide meaningful access to their programs by persons with limited English proficiency. Please see
The HHS Office for Civil Rights (OCR) also provides guidance on complying with civil rights laws enforced by HHS. Please see
Pursuant to 45 CFR 80.3(d), an individual shall not be deemed subjected to discrimination by reason of his/her exclusion from benefits limited by Federal law to individuals eligible for benefits and services from the IHS.
Recipients will be required to sign the HHS-690 Assurance of Compliance form which can be obtained from the following website:
The IHS is required to review and consider any information about the applicant that is in the Federal Awardee Performance and Integrity Information System
As required by 45 CFR part 75 Appendix XII of the Uniform Guidance, non-Federal entities (NFEs) are required to disclose in FAPIIS any information about criminal, civil, and administrative proceedings, and/or affirm that there is no new information to provide. This applies to NFEs that receive Federal awards (currently active grants, cooperative agreements, and procurement contracts) greater than $10,000,000 for any period of time during the period of performance of an award/project.
As required by 2 CFR part 200 of the Uniform Guidance, and the HHS implementing regulations at 45 CFR part 75, effective January 1, 2016, the IHS must require a non-Federal entity or an applicant for a Federal award to disclose, in a timely manner, in writing to the IHS or pass-through entity all violations of Federal criminal law involving fraud, bribery, or gratuity violations potentially affecting the Federal award.
Submission is required for all applicants and recipients, in writing, to the IHS and to the HHS Office of Inspector General all information related to violations of Federal criminal law involving fraud, bribery, or gratuity violations potentially affecting the Federal award. 45 CFR 75.113.
Disclosures must be sent in writing to:
Failure to make required disclosures can result in any of the remedies described in 45 CFR 75.371 Remedies for noncompliance, including suspension or debarment (See 2 CFR parts 180 & 376 and 31 U.S.C. 3321).
1. Questions on the programmatic issues may be directed to: Roxanne
2. Questions on grants management and fiscal matters may be directed to: Vanietta Armstrong, Grants Management Specialist, 5600 Fishers Lane, Mail Stop: 09E70, Rockville, MD 20857, Phone: (301) 443-4792, Fax: (301) 594-0899, Email:
3. Questions on systems matters may be directed to: Paul Gettys, Grant Systems Coordinator, 5600 Fishers Lane, Mail Stop: 09E70, Rockville, MD 20857, Phone: (301) 443-2114; or the DGM main line (301) 443-5204, Fax: (301) 594-0899, Email:
The Public Health Service strongly encourages all cooperative agreement and contract recipients to provide a smoke-free workplace and promote the non-use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of the facility) in which regular or routine education, library, day care, health care, or early childhood development services are provided to children. This is consistent with the HHS mission to protect and advance the physical and mental health of the American people.
The Indian Health Service (IHS) Office of Tribal Self-Governance (OTSG), is accepting applications for Planning Cooperative Agreements for the Tribal Self-Governance Program (TSGP). This program is authorized under: Title V of the Indian Self-Determination and Education Assistance Act (ISDEAA), 25 U.S.C. 5383(e). This program is described in the Catalog of Federal Domestic Assistance (CFDA) under 93.444.
The TSGP is more than an IHS program; it is an expression of the Government-to-Government relationship between the United States (U.S.) and Indian Tribes. Through the TSGP, Tribes negotiate with the IHS to assume Programs, Services, Functions, and Activities (PSFAs), or portions thereof, which gives Tribes the authority to manage and tailor health care programs in a manner that best fits the needs of their communities.
Participation in the TSGP affords Tribes the most flexibility to tailor health care PSFAs and is one of three ways that Tribes can choose to obtain health care from the Federal Government for their citizens. Specifically, Tribes can choose to: (1) Receive health care services directly from the IHS, (2) contract with the IHS to administer individual programs and services the IHS would otherwise provide (referred to as Title I Self-Determination Contracting, and (3) compact with the IHS to assume control over health care programs the IHS would otherwise provide (referred to as Title V Self-Governance Compacting or the TSGP). These options are not exclusive and Tribes may choose to combine options based on their individual needs and circumstances.
The TSGP is a tribally driven initiative, and strong Federal-Tribal partnerships are essential to the program's success. The IHS established the OTSG to implement the self-governance authorities under the ISDEAA. The primary OTSG functions are to: (1) Serve as the primary liaison and advocate for Tribes participating in the TSGP, (2) develop, direct, and implement TSGP policies and procedures, (3) provide information and technical assistance to Self-Governance Tribes, and (4) advise the IHS Director on compliance with TSGP policies, regulations, and guidelines. Each IHS Area has an Agency Lead Negotiator (ALN), designated by the IHS Director to act on his or her behalf, who has authority to negotiate Self-Governance Compacts and Funding Agreements. Prospective Tribes interested in participating in the TSGP should contact their respective ALN to begin the Self-Governance planning process. Also, Tribes currently participating in the TSGP, who are interested in expanding existing or adding new PSFAs should also contact their respective ALN to discuss the best methods for expanding or adding new PSFAs.
The purpose of this Planning Cooperative Agreement is to provide resources to Tribes interested in entering the TSGP and to existing Self-Governance Tribes interested in assuming new or expanded PSFAs. Title V of the ISDEAA requires a Tribe or Tribal organization to complete a planning phase to the satisfaction of the Tribe. The planning phase must include legal and budgetary research and internal Tribal government planning and organizational preparation relating to the administration of health care programs. See 25 U.S.C. 5383(d).
The planning phase is critical to negotiations and helps Tribes make informed decisions about which PSFAs to assume and what organizational changes or modifications are necessary to successfully support those PSFAs. A thorough planning phase improves timeliness and efficient negotiations and ensures that the Tribe is fully prepared to assume the transfer of IHS PSFAs to the Tribal health program.
A Planning Cooperative Agreement is not a prerequisite to enter the TSGP and a Tribe may use other resources to meet the planning requirement. Tribes that receive Planning Cooperative Agreements are not obligated to participate in the TSGP and may choose to delay or decline participation based on the outcome of their planning activities. This also applies to existing Self-Governance Tribes exploring the option to expand their current PSFAs or assume additional PSFAs.
There is limited competition under this announcement because the authorizing legislation restricts eligibility to Tribes that meet specific criteria identified in Section III. Eligibility Criteria, 1. Eligibility, A. See 25 U.S.C. 5383(e); 42 CFR 137.10 and §§ 137.24-26.
Cooperative Agreement.
The total amount of funding identified for the current fiscal year (FY) 2018 is approximately $600,000. Individual award amounts are anticipated to be $120,000. The amount of funding available for awards issued under this announcement are subject to the availability of appropriations and budgetary priorities of the Agency. The IHS is under no obligation to make awards that are selected for funding under this announcement.
Approximately five awards will be issued under this program announcement.
The period of performance is for one year and will run consecutively from July 15, 2018, to July 14, 2019.
Cooperative agreements awarded by the Department of Health and Human Services (HHS) are administered under the same policies as a grant. However, the IHS is required to have substantial programmatic involvement in the project during the entire award segment. Below is a detailed description of the level of involvement required for both IHS and the grantee. The IHS will be responsible for activities listed under section A and the grantee will be responsible for activities listed under section B as stated:
(1) Provide descriptions of PSFAs and associated funding at all organizational levels (service unit, area, and headquarters), including funding formulas and methodologies related to determining Tribal shares.
(2) Meet with Planning Cooperative Agreement recipients to provide program information and discuss methods currently used to manage and deliver health care.
(3) Identify and provide statutes, regulations, and policies that provide authority for administering IHS programs.
(4) Provide technical assistance on the IHS budget, Tribal shares, and other topics as needed.
(1) Research and analyze the complex IHS budget to gain a thorough understanding of funding distribution at all organizational levels and to determine which PSFAs the Tribe may elect to assume or expand.
(2) Establish a process by which Tribes may approach the IHS to identify PSFAs and associated funding that may be incorporated into their current programs.
(3) Determine the Tribe's share of each Program, Service, Function and Activity and evaluate the current level of healthcare services being provided to make an informed decision on new or expanded program assumption(s).
To be eligible for the New Limited Competition Planning Cooperative Agreement under this announcement, an applicant must:
(A) Be an “Indian Tribe” as defined in 25 U.S.C. 5304(e); a “Tribal Organization” as defined in 25 U.S.C. 5304(l); or an “Inter-Tribal Consortium: As defined at 42 CFR 137.10. However, Alaska Native Villages or Alaska Native Village Corporations are not eligible if they are located within the area served by an Alaska Native regional health entity. See Consolidated Appropriations Act, 2014, Public Law 113-76. By statute, the Native Village of Eyak, Eastern Aleutian Tribes, and the Council for Athabascan Tribal Governments have also been deemed Alaska Native regional health entities and therefore are eligible to apply. Those Alaska Tribes not represented by a Self-Governance Tribal consortium Funding Agreement within their area may still be considered to participate in the TSGP.
(B) Submit Tribal resolution(s) from the appropriate governing body of each Indian Tribe to be served by the ISDEAA Compact authorizing the submission of the Planning Cooperative Agreement. Tribal consortia applying for a Planning Cooperative Agreement shall submit Tribal Council resolutions from each Tribe in the consortium. Tribal resolutions can be attached to the electronic online application.
(C) Demonstrate for three fiscal years, financial stability and financial management capability. The Indian Tribe must provide evidence that, for the three fiscal years prior to requesting participation in the TSGP, the Indian Tribe has had no uncorrected significant and material audit exceptions in the required annual audit of the Indian Tribe's Self-Determination Contracts or Self-Governance Funding Agreements with any Federal Agency. See 25 U.S.C. 5383; 42 CFR 137.15-23.
For Tribes or Tribal organizations (T/TO) that expended $750,000 or more ($500,000 for fiscal years ending after December 31, 2003) in Federal awards, the OTSG shall retrieve the audits directly from the Federal Audit Clearinghouse.
For T/TO that expended less than $750,000 ($500,000 for fiscal years ending after December 31, 2003) in Federal awards, the T/TO must provide evidence of the program review correspondence from IHS or Bureau of Indian Affairs officials.
Please refer to Section IV.2 (Application and Submission Information/Subsection 2, Content and Form of Application Submission) for additional proof of applicant status documents required, such as Tribal resolutions, proof of non-profit status, etc.
The IHS does not require matching funds or cost sharing for grants or cooperative agreements.
If application budgets exceed the highest dollar amount outlined under the “Estimated Funds Available” section within this funding announcement, the application will be considered ineligible and will not be reviewed for further consideration. If deemed ineligible, IHS will not return the application. The applicant will be notified by email by the Division of Grants Management (DGM) of this decision.
Submit Tribal resolution(s) from the appropriate governing body of the Indian Tribe to be served by the ISDEAA Compact authorizing the submission of a Negotiation Cooperative Agreement application. Tribal consortia applying for a TSGP Negotiation Cooperative Agreement shall submit Tribal Council resolutions from each Tribe in the consortium. Tribal
An official signed Tribal resolution must be received by the DGM prior to a Notice of Award (NoA) being issued to any applicant selected for funding. However, if an official signed Tribal resolution cannot be submitted with the electronic application submission prior to the official application deadline date, then a draft Tribal resolution is acceptable and must be submitted by the deadline in order for the application to be considered complete and eligible for review. The draft Tribal resolution is not in lieu of the required signed resolution, but is acceptable until a signed resolution is received. If an official signed Tribal resolution is not received by DGM when funding decisions are made, then a NoA will not be issued to that applicant and they will not receive any IHS funds until such time as they have submitted a signed resolution to the Grants Management Specialist listed in this funding announcement.
An applicant submitting Tribal resolution(s) after the initial application submission due date is required to ensure the information was received by the IHS by obtaining documentation confirming delivery (
The application package and detailed instructions for this announcement can be found at:
Questions regarding the electronic application process may be directed to Mr. Paul Gettys at (301) 443-2114 or (301) 443-5204.
The applicant must include the project narrative as an attachment to the application package. Mandatory documents for all applicants include:
• Table of contents.
• Abstract (one page) summarizing the project.
• Application forms:
○ SF-424, Application for Federal Assistance.
○ SF-424A, Budget Information—Non-Construction Programs.
○ SF-424B, Assurances—Non-Construction Programs.
• Line Item Budget and Narrative (must be single-spaced and not exceed five pages).
• Project Narrative (must be single-spaced and not exceed ten pages).
○ Background information on the organization.
○ Proposed scope of work, objectives, and activities that provide a description of what will be accomplished, including a one-page Timeframe Chart.
• Tribal Resolution(s).
• Letters of Support from organization's Board of Directors.
• 501(c)(3) Certificate (if applicable).
• Biographical sketches for all Key Personnel.
• Contractor/Consultant resumes or qualifications and scope of work.
• Disclosure of Lobbying Activities (SF-LLL).
• Certification Regarding Lobbying (GG-Lobbying Form).
• Copy of current Negotiated Indirect Cost rate (IDC) agreement (required in order to receive IDC).
• Organizational Chart (optional).
• Documentation of current Office of Management and Budget (OMB) Financial Audit.
Acceptable forms of documentation include:
○ Email confirmation from Federal Audit Clearinghouse (FAC) that audits were submitted; or
○ Face sheets from audit reports. These can be found on the FAC website:
All Federal-wide public policies apply to IHS grants and cooperative agreements with exception of the Discrimination Policy.
Be sure to succinctly answer all questions listed under the evaluation criteria (refer to Section V.1, Evaluation criteria in this announcement) and place all responses and required information in the correct section (noted below), or they will not be considered or scored. These narratives will assist the Objective Review Committee (ORC) in becoming familiar with the applicant's activities and accomplishments prior to this possible cooperative agreement award. If the narrative exceeds the page limit, then only the first ten pages will be reviewed. The ten page limit for the narrative does not include the work plan, standard forms, Tribal resolutions, table of contents, budget, budget justifications, narratives, and/or other appendix items.
There are three parts to the narrative: Part A—Program Information; Part B—Program Planning and Evaluation; and Part C—Program Report. See below for additional details about what must be included in the narrative.
The page limitations below are for each narrative and budget submitted.
Describe the Tribe's current health program activities, including: How long it has been operating, what programs or services are currently being provided, and if the applicant is currently administering any ISDEAA Title I Self-Determination Contracts or Title V Self-Governance Compacts. Identify the need for assistance and how the Planning Cooperative Agreement would benefit the health activities the Tribe is currently administering or looking to expand.
State in measureable terms
(A) Research and analyze the complex IHS budget to gain a thorough understanding of funding distribution at all organizational levels and determine which PSFAs the Tribe may elect to assume or expand.
(B) Establish a process to identify PSFAs and associated funding that may be incorporated into current programs.
(C) Determine the Tribe's share of each Program, Service, Function and Activity and evaluate the current level of health care services being provided to make an informed decision on new or expanded program assumption.
(D) Describe how the objectives are consistent with the purpose of the program, the needs of the people to be served, and how they will be achieved within the proposed time frame. Identify the expected results, benefits, and outcomes or products to be derived from each objective of the project.
Describe the organizational structure of the Tribe and its ability to manage the proposed project. Include resumes or
Define the criteria to be used to evaluate planning activities. Describe fully and clearly the methodology that will be used to determine if the needs identified are being met and if the outcomes are being achieved. This section must address the following questions:
(A) Are the goals and objectives measurable and consistent with the purpose of the program and the needs of the people to be served?
(B) Are they achievable within the proposed time frame?
This narrative must include a line item budget with a narrative justification for all expenditures identifying reasonable allowable, allocable costs necessary to accomplish the goals and objectives as outlined in the project narrative. Budget should match the scope of work described in the project narrative.
Applications must be submitted electronically through
If technical challenges arise and assistance is required with the electronic application process, contact
Executive Order 12372 requiring intergovernmental review is not applicable to this program.
• Pre-award costs are not allowable.
• The available funds are inclusive of direct and appropriate indirect costs.
• Tribes can apply and be awarded both a Planning Cooperative Agreement and a Negotiation Cooperative Agreement in the same cycle, so long as the project proposals are different for each application. Tribes cannot apply for both the Planning Cooperative Agreement and the Negotiation Cooperative Agreement within the same grant cycle with the same proposed project.
• Only one Planning grant/cooperative agreement will be awarded per applicant per grant cycle under this announcement.
• IHS will not acknowledge receipt of applications.
All applications must be submitted electronically. Please use the
If the applicant needs to submit a paper application instead of submitting electronically through
Once the waiver request has been approved, the applicant will receive a confirmation of approval email containing submission instructions and the mailing address to submit the application. A copy of the written approval must be submitted along with the hardcopy of the application that is mailed to DGM. Paper applications that are submitted without a copy of the signed waiver from the Director of the DGM will not be reviewed or considered for funding. The applicant will be notified via email of this decision by the Grants Management Officer of the DGM. Paper applications must be received by the DGM no later than 5:00 p.m., EDT, on the Application Deadline Date listed in the Key Dates section on page one of this announcement. Late applications will not be accepted for processing or considered for funding. Applicants that do not adhere to the timelines for System for Award Management (SAM) and/or
Please be aware of the following:
• Please search for the application package in
• If you experience technical challenges while submitting your application electronically, please contact
• Upon contacting
• Applicants are strongly encouraged not to wait until the deadline date to begin the application process through
• Please use the optional attachment feature in
• All applicants must comply with any page limitation requirements described in this funding announcement.
• After electronically submitting the application, the applicant will receive an automatic acknowledgment from
• Email applications will not be accepted under this announcement.
All IHS applicants and grantee organizations are required to obtain a DUNS number and maintain an active registration in the SAM database. The DUNS number is a unique 9-digit identification number provided by D&B which uniquely identifies each entity. The DUNS number is site specific; therefore, each distinct performance site may be assigned a DUNS number. Obtaining a DUNS number is easy, and there is no charge. To obtain a DUNS number, you may access it through
All HHS recipients are required by the Federal Funding Accountability and Transparency Act of 2006, as amended (“Transparency Act”), to report information on sub-awards. Accordingly, all IHS grantees must notify potential first-tier sub-recipients that no entity may receive a first-tier sub-award unless the entity has provided its DUNS number to the prime grantee organization. This requirement ensures the use of a universal identifier to enhance the quality of information available to the public pursuant to the Transparency Act.
Organizations that were not registered with Central Contractor Registration and have not registered with SAM will need to obtain a DUNS number first and then access the SAM online registration through the SAM home page at:
Additional information on implementing the Transparency Act, including the specific requirements for DUNS and SAM, can be found on the IHS Grants Management, Grants Policy website:
The instructions for preparing the application narrative also constitute the evaluation criteria for reviewing and scoring the application. Weights assigned to each section are noted in parentheses. The ten page narrative section should be written in a manner that is clear to outside reviewers unfamiliar with prior related activities of the applicant. It should be well organized, succinct, and contain all information necessary for reviewers to understand the project fully. Points will be assigned to each evaluation criteria adding up to a total of 100 points. A minimum score of 60 points is required for funding. Points are assigned as follows:
Describe the Tribe's current health program activities, including: How long it has been operating, what programs or services are currently being provided, and if the applicant is currently administering any ISDEAA Title I Self-Determination Contracts or Title V Self-Governance Compacts. Identify the need for assistance and how the Planning Cooperative Agreement would benefit the health activities the Tribe is currently administering and/or looking to expand.
State in measurable terms the objectives and appropriate activities to achieve the following Planning Cooperative Agreement recipient award activities:
(1) Research and analyze the complex IHS budget to gain a thorough understanding of funding distribution at all organizational levels and determine which PSFAs the Tribe may elect to assume or expand.
(2) Establish a process to identify PSFAs and associated funding that may be incorporated into current programs.
(3) Determine the Tribe's share of each Program, Service, Function and Activity and evaluate the current level of health care services being provided to make an informed decision on new or expanded program assumption.
(4) Describe how the objectives are consistent with the purpose of the program, the needs of the people to be served, and how they will be achieved within the proposed time frame. Identify the expected results, benefits, and outcomes or products to be derived from each objective of the project.
Define the criteria to be used to evaluate planning activities. Clearly describe the methodologies and parameters that will be used to determine if the needs identified are being met and if the outcomes identified are being achieved. Are the goals and objectives measurable and consistent with the purpose of the program and meet the needs of the people to be served? Are they achievable within the proposed time frame? Describe how the assumption of PSFAs enhances sustainable health delivery. Ensure the measurement includes activities that will lead to sustainability.
Describe the organizational structure of the Tribe and its ability to manage the proposed project. Include resumes or position descriptions of key staff showing requisite experience and expertise. If applicable, include resumes and scope of work for consultants that demonstrate experience and expertise relevant to the project.
Submit a budget with a narrative describing the budget request and matching the scope of work described in the project narrative. Justify all expenditures identifying reasonable and allowable costs necessary to accomplish the goals and objectives as outlined in the project narrative.
• Work plan, logic model and/or time line for proposed objectives.
• Position descriptions for key staff.
• Resumes of key staff that reflect current duties.
• Consultant or contractor proposed scope of work and letter of commitment (if applicable).
• Current Indirect Cost Agreement.
• Organizational chart.
• Map of area identifying project location(s).
• Additional documents to support narrative (
Each application will be prescreened by the DGM staff for eligibility and completeness as outlined in the funding announcement. Applications that meet the eligibility criteria shall be reviewed for merit by the ORC based on evaluation criteria in this funding announcement. The ORC could be composed of both Tribal and Federal reviewers appointed by the IHS Program to review and make recommendations on these applications. The technical review process ensures selection of quality projects in a national competition for limited funding. Incomplete applications and applications that are non-responsive to the eligibility criteria will not be referred to the ORC. The applicant will be notified via email of this decision by the Grants Management Officer of the DGM. Applicants will be notified by DGM, via email, to outline minor missing components (
To obtain a minimum score for funding by the ORC, applicants must address all program requirements and provide all required documentation.
The NoA is a legally binding document signed by the Grants Management Officer and serves as the official notification of the grant award. The NoA will be initiated by the DGM in our grant system, GrantSolutions (
Applicants who received a score less than the recommended funding level for approval, 60 and were deemed to be disapproved by the ORC, will receive an Executive Summary Statement from the OTSG within 30 days of the conclusion of the ORC outlining the strengths and weaknesses of their application. The summary statement will be sent to the Authorized Organizational Representative that is identified on the face page (SF-424) of the application. The OTSG will also provide additional contact information as needed to address questions and concerns as well as provide technical assistance if desired.
Approved but unfunded applicants that met the minimum scoring range and were deemed by the ORC to be “Approved,” but were not funded due to lack of funding, will have their applications held by DGM for a period of one year. If additional funding becomes available during the course of FY 2018 the approved but unfunded application may be re-considered by the OTSG for possible funding. The applicant will also receive an Executive Summary Statement from the OTSG within 30 days of the conclusion of the ORC.
Any correspondence other than the official NoA signed by an IHS grants management official announcing to the project director that an award has been made to their organization is not an authorization to implement their program on behalf of the IHS.
Cooperative agreements are administered in accordance with the following regulations and policies:
A. The criteria as outlined in this program announcement.
B. Administrative Regulations for Grants:
• Uniform Administrative Requirements for HHS Awards, located at 45 CFR part 75, located on the U.S. Government Publishing Office website at:
C. Grants Policy:
• HHS Grants Policy Statement, Revised 01/07 located at:
D. Cost Principles:
• Uniform Administrative Requirements for HHS Awards, “Cost Principles,” located at 45 CFR part 75, subpart E.
E. Audit Requirements:
• Uniform Administrative Requirements for HHS Awards, “Audit Requirements,” located at 45 CFR part 75, subpart F.
This section applies to all grant recipients that request reimbursement of indirect costs (IDC) in their grant application. In accordance with HHS Grants Policy Statement, Part II-27, IHS requires applicants to obtain a current IDC rate agreement prior to award. The rate agreement must be prepared in accordance with the applicable cost principles and guidance as provided by the cognizant agency or office. A current rate covers the applicable grant activities under the current award's budget period. If the current rate is not on file with the DGM at the time of award, the IDC portion of the budget will be restricted. The restrictions remain in place until the current rate is provided to the DGM.
Generally, IDC rates for IHS grantees are negotiated with the Division of Cost Allocation (DCA)
The grantee must submit required reports consistent with the applicable deadlines. Failure to submit required reports within the time allowed may result in suspension or termination of an active grant, withholding of additional awards for the project, or other enforcement actions such as withholding of payments or converting to the reimbursement method of payment. Continued failure to submit required reports may result in one or both of the following: (1) The imposition of special award provisions, and (2) the non-funding or non-award of other eligible projects or activities. This requirement applies whether the delinquency is attributable to the failure of the grantee organization or the individual responsible for preparation of the reports. Per DGM policy, all reports are required to be submitted electronically by attaching them as a “Grant Note” in GrantSolutions. Personnel responsible for submitting reports will be required to obtain a login and password for GrantSolutions. Please see the Agency Contacts list in section VII for the systems contact information.
The reporting requirements for this program are noted below.
Program progress reports are required semi-annually. These reports must include a brief comparison of actual accomplishments to the goals established for the six month period, a summary of progress to date or, if applicable, provide sound justification for the lack of progress, and other pertinent information as required by the program office. A final report must be submitted within 90 days of expiration of the budget or period of performance.
Federal Financial Report (FFR or SF-425), Cash Transaction Reports are due 30 days after the close of every calendar quarter to the Payment Management Services, HHS at:
Grantees are responsible and accountable for accurate information being reported on all required reports: The Progress Reports and Federal Financial Report.
This award may be subject to the Transparency Act sub-award and executive compensation reporting requirements of 2 CFR part 170.
The Transparency Act requires the OMB to establish a single searchable database, accessible to the public, with information on financial assistance awards made by Federal agencies. The Transparency Act also includes a requirement for recipients of Federal grants to report information about first-tier sub-awards and executive compensation under Federal assistance awards.
IHS has implemented a Term of Award into all IHS Standard Terms and Conditions, NoAs and funding announcements regarding the FSRS reporting requirement. This IHS Term of Award is applicable to all IHS grant and cooperative agreements issued on or after October 1, 2010, with a $25,000 sub-award obligation dollar threshold met for any specific reporting period. Additionally, all new (discretionary) IHS awards (where the period of performance is made up of more than one budget period) and where: (1) The period of performance start date was October 1, 2010, or after, and (2) the primary awardee will have a $25,000 sub-award obligation dollar threshold during any specific reporting period will be required to address the FSRS reporting.
For the full IHS award term implementing this requirement and additional award applicability information, visit the DGM Grants Policy website at:
Recipients of Federal financial assistance (FFA) from HHS must administer their programs in compliance with Federal civil rights law. This means that recipients of HHS funds must ensure equal access to their programs without regard to a person's race, color, national origin, disability, age and, in some circumstances, sex and religion. This includes ensuring your programs are accessible to persons with limited English proficiency. HHS provides guidance to recipients of FFA on meeting their legal obligation to take reasonable steps to provide meaningful access to their programs by persons with limited English proficiency. Please see
The HHS Office for Civil Rights (OCR) also provides guidance on complying with civil rights laws enforced by HHS. Please see
Pursuant to 45 CFR 80.3(d), an individual shall not be deemed subjected to discrimination by reason of his/her exclusion from benefits limited by Federal law to individuals eligible for benefits and services from the IHS.
Recipients will be required to sign the HHS-690 Assurance of Compliance form which can be obtained from the following website:
The IHS is required to review and consider any information about the applicant that is in the Federal Awardee Performance and Integrity Information System (FAPIIS) before making any award in excess of the simplified acquisition threshold (currently $150,000) over the period of performance. An applicant may review and comment on any information about itself that a Federal awarding agency previously entered. IHS will consider any comments by the applicant, in addition to other information in FAPIIS in making a judgment about the applicant's integrity, business ethics, and record of performance under Federal awards when completing the review of risk posed by applicants as described in 45 CFR 75.205.
As required by 45 CFR part 75 Appendix XII of the Uniform Guidance, non-Federal entities (NFEs) are required to disclose in FAPIIS any information about criminal, civil, and administrative proceedings, and/or affirm that there is no new information to provide. This applies to NFEs that receive Federal awards (currently active grants, cooperative agreements, and procurement contracts) greater than $10,000,000 for any period of time during the period of performance of an award/project.
As required by 2 CFR part 200 of the Uniform Guidance, and the HHS implementing regulations at 45 CFR part 75, effective January 1, 2016, the IHS must require a non-Federal entity or an applicant for a Federal award to disclose, in a timely manner, in writing to the IHS or pass-through entity all violations of Federal criminal law involving fraud, bribery, or gratuity violations potentially affecting the Federal award.
Disclosures must be sent in writing to:
Failure to make required disclosures can result in any of the remedies described in 45 CFR 75.371 Remedies for noncompliance, including suspension or debarment (See 2 CFR parts 180 & 376 and 31 U.S.C. 3321).
1. Questions on the programmatic issues may be directed to: Roxanne Houston, Program Officer, Office of Tribal Self-Governance, 5600 Fishers Lane, Mail Stop: 08E05, Rockville, MD 20857, Phone: (301) 443-7821, Email:
2. Questions on grants management and fiscal matters may be directed to: Vanietta Armstrong, Grants Management Specialist, 5600 Fishers Lane, Mail Stop: 09E70, Rockville, MD 20857, Phone: (301) 443-4792, Fax: 301-594-0899, Email:
3. Questions on systems matters may be directed to: Paul Gettys, Grant Systems Coordinator, 5600 Fishers Lane, Mail Stop: 09E70, Rockville, MD 20857, Phone: (301) 443-2114; or the DGM main line (301) 443-5204, Fax: (301) 594-0899, E-Mail:
The Public Health Service strongly encourages all cooperative agreement and contract recipients to provide a smoke-free workplace and promote the non-use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of the facility) in which regular or routine education, library, day care, health care, or early childhood development services are provided to children. This is consistent with the HHS mission to protect and advance the physical and mental health of the American people.
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 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 a meeting of the National Advisory Dental and Craniofacial Research Council.
The meeting will be open to the public as indicated below, 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 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.
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:
Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended, notice is hereby given of a meeting of the Board of Scientific Counselors, National Institute of Dental and Craniofacial Research.
The meeting will be closed to the public as indicated below in accordance with the provisions set forth in section 552b(c)(6), Title 5 U.S.C., as amended for the review, discussion, and evaluation of individual intramural programs and projects conducted by the National Institute of Dental and Craniofacial Research, including consideration of personnel qualifications and performance, and the competence of individual investigators, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.
Information is also available on the Institute's/Center's home page:
Pursuant to section 10(a) of the Federal Advisory Committee Act, as amended, notice is hereby given of meetings of the Task Force on Research Specific to Pregnant Women and Lactating Women.
The meetings will be open to the public, with attendance limited to space available. Individuals who plan to
Public comments are welcome either by filing written comments and/or providing oral comments at the meeting. Oral comments from the public will be scheduled on May 14, 2018, from approximately 10:00 a.m.-10:45 a.m. Any member of the public interested in presenting oral comments on May 14, 2018, should submit a letter of intent, a brief description of the organization represented, and the oral presentation to Ms. Lisa Kaeser (
The submitted presentations and any written comments will be formatted to be posted on the PRGLAC website for the record. Only one representative of an organization may be allowed to present oral comments. Presentations will be limited to three to five minutes per speaker depending on the number of speakers to be accommodated within the allotted time. Speakers will be assigned a time to speak in the order of the date and time when their request to speak is received. Both printed and electronic copies are requested for the record.
Details and additional information about these meetings can be found at the NICHD website for the Task Force on Research Specific to Pregnant Women and Lactating Women (PRGLAC)
U.S. Customs and Border Protection, Department of Homeland Security.
Notice of accreditation and approval of Camin Cargo Control, Inc., as a commercial gauger and laboratory.
Notice is hereby given, pursuant to CBP regulations, that Camin Cargo Control, Inc., has been approved to gauge and accredited to test petroleum and certain petroleum products for customs purposes for the next three years as of July 6, 2017.
The accreditation and approval of Camin Cargo Control, Inc., as commercial gauger and laboratory became effective on July 6, 2017. The next triennial inspection date will be scheduled for July 2020.
Mr. Stephen Cassata, Laboratories and Scientific Services Directorate, U.S. Customs and Border Protection, 1300 Pennsylvania Avenue NW, Suite 1500N, Washington, DC 20229, tel. 202-344-1060.
Notice is hereby given pursuant to 19 CFR 151.12 and 19 CFR 151.13, that Camin Cargo Control, Inc., 1301 Metropolitan Ave., Thorofare, NJ 08086, has been approved to gauge and accredited to test petroleum and certain petroleum products for customs purposes, in accordance with the provisions of 19 CFR 151.12 and 19 CFR 151.13. Camin Cargo Control, Inc., is approved for the following gauging procedures for petroleum and certain petroleum products set forth by the American Petroleum Institute (API):
Camin Cargo Control, Inc., is accredited for the following laboratory analysis procedures and methods for petroleum and certain petroleum products set forth by the U.S. Customs and Border Protection Laboratory Methods (CBPL) and American Society for Testing and Materials (ASTM):
Anyone wishing to employ this entity to conduct laboratory analyses and gauger services should request and receive written assurances from the entity that it is accredited or approved by the U.S. Customs and Border Protection to conduct the specific test or gauger service requested. Alternatively, inquiries regarding the specific test or gauger service this entity is accredited or approved to perform may be directed to the U.S. Customs and Border Protection by calling (202) 344-1060. The inquiry may also be sent to
U.S. Customs and Border Protection, Department of Homeland Security.
Notice of approval of Intertek USA, Inc., as a commercial gauger.
Notice is hereby given, pursuant to CBP regulations, that
The approval of Intertek USA, Inc., as commercial gauger became effective on September 20, 2017. The next triennial inspection date will be scheduled for September 2020.
Mr. Stephen Cassata, Laboratories and Scientific Services, U.S. Customs and Border Protection, 1300 Pennsylvania Avenue NW, Suite 1500N, Washington, DC 20229, tel. 202-344-1060.
Notice is hereby given pursuant to 19 CFR 151.13, that Intertek USA, Inc., 1020 South Holland Sylvania Rd., Holland, OH 43528, has been approved to gauge petroleum and certain petroleum products for customs purposes, in accordance with the provisions of 19 CFR 151.13. Intertek USA, Inc., is approved for the following gauging procedures for petroleum and certain petroleum products set forth by the American Petroleum Institute (API):
Anyone wishing to employ this entity to conduct gauger services should request and receive written assurances from the entity that it is approved by the U.S. Customs and Border Protection to conduct the specific gauger service requested. Alternatively, inquiries regarding the specific gauger service this entity is approved to perform may be directed to the U.S. Customs and Border Protection by calling (202) 344-1060. The inquiry may also be sent to
U.S. Customs and Border Protection (CBP), Department of Homeland Security.
60-Day Notice and request for comments; revision and extension of an existing collection of information.
The Department of Homeland Security, U.S. Customs and Border Protection will be submitting the following information collection request to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act of 1995 (PRA). The information collection is published in the
Written comments and/or suggestions regarding the item(s) contained in this notice must include the OMB Control Number 1651-0024 in the subject line and the agency name. To avoid duplicate submissions, please use only
(1)
(2)
Requests for additional PRA information should be directed to Seth Renkema, Chief, Economic Impact Analysis Branch, U.S. Customs and Border Protection, Office of Trade, Regulations and Rulings, 90 K Street NE, 10th Floor, Washington, DC 20229-1177, Telephone number (202) 325-0056 or via email
CBP invites the general public and other Federal agencies to comment on the proposed and/or continuing information collections pursuant to the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq.). This process is conducted in accordance with 5 CFR 1320.8. Written comments and suggestions from the public and affected agencies should address one or more of the following four points: (1) 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; (2) 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; (3) suggestions to enhance the quality, utility, and clarity of the information to be collected; and (4) suggestions to 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,
Change one submitted on February 22, 2018: CBP is submitting this Non Substantive Change to OMB to reflect a change in the Harmonized Tariff Schedule (HTS) which is maintained by the U.S. International Trade Commission (USITC). HTS data is provided to CBP at entry.
Effective February 7, 2018, the following changes to the Harmonized Tariff Schedule for units of quantity reporting will take effect:
• For HTS 8450.90.20 and 8450.90.60, certain parts of washing machines, the new unit of quantity will be “No.” instead of “X”.
• For HTS 8541.40.6030, solar cells, a second unit of quantity, “W” (for total wattage), will be added.
• For statistical reporting purposes under subheading 8541.40.6030, importers should report the total watts at maximum power based on standard test conditions according to the latest revision of International Electrotechnical Commission (IEC) 60904, “Photovoltaic Devices.”
• These modifications will take effect as announced in Presidential Proclamations 9693 (83 FR 3541) and 9694 (83 FR 3553), of January 23, 2018.
For additional information regarding the HTS please follow this link:
Change two submitted on March 19, 2018: CBP is submitting this Non Substantive change to reflect an adjustment in ACE Cargo due to U.S. Department of Commerce Bureau of Industry and Security (BIS) for Procedures for Submitting Requests for Exclusions from the Section 232 National Security Adjustments of Imports of Steel and Aluminum information collection. Importers who have submitted for exclusion from Section 232 shall submit the BIS exclusion number in the additional importer declaration field. This collection is authorized by 15 CFR 705,
CBP Forms 3461 and 3461 ALT are provided for by 19 CFR 141 and 142. These forms and instructions for Form 3461 are accessible at:
ACE Cargo Release is a program for ACE entry summary filers in which importers or brokers may file Simplified Entry data in lieu of filing the CBP Form 3461. This data consists of 12 required elements: Importer of record; buyer name and address; buyer employer identification number (consignee number), seller name and address; manufacturer/supplier name and address; Harmonized Tariff Schedule 10-digit number; country of origin; bill of lading; house air waybill number; bill of lading issuer code; entry number; entry type; and estimated shipment value. Three optional data elements are the container stuffing location; consolidator name and address, and ship to party name and address. The data collected under the ACE Cargo Release program is intended to reduce transaction costs, expedite cargo release, and enhance cargo security. ACE Cargo Release filing minimizes the redundancy of data submitted by the filer to CBP through receiving carrier data from the carrier. This design allows the participants to file earlier in the transportation flow. Guidance on using ACE Cargo Release may be found at
Office of the Chief Information Officer, HUD.
Notice.
HUD submitted the proposed information collection requirement described below to the Office of Management and Budget (OMB) for review, in accordance with the Paperwork Reduction Act. The purpose of this notice is to allow for 30 days of public comment.
Interested persons are invited to submit comments regarding this proposal. Comments should refer to the proposal by name and/or OMB Control Number and should be sent to: HUD Desk Officer, Office of Management and Budget, New Executive Office Building, Washington, DC 20503; fax:202-395-5806, Email:
Inez C. Downs, Reports Management Officer, QMAC, Department of Housing and Urban Development, 451 7th Street SW, Washington, DC 20410; email
Copies of available documents submitted to OMB may be obtained from Ms. Downs.
This notice informs the public that HUD is seeking approval from OMB for the information collection described in Section A.
The
This notice is soliciting comments from members of the public and affected parties concerning the collection of information described in Section A on the following:
(1) 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;
(2) The accuracy of the agency's estimate of the burden of the proposed collection of information;
(3) Ways to enhance the quality, utility, and clarity of the information to be collected; and
(4) Ways to minimize the burden of the collection of information on those who are to respond: Including through the use of appropriate automated collection techniques or other forms of information technology,
HUD encourages interested parties to submit comment in response to these questions.
Section 3507 of the Paperwork Reduction Act of 1995, 44 U.S.C. Chapter 35.
Office of the Chief Information Officer, HUD.
Notice.
HUD submitted the proposed information collection requirement described below to the Office of Management and Budget (OMB) for review, in accordance with the Paperwork Reduction Act. The purpose of this notice is to allow for 30 days of public comment.
Interested persons are invited to submit comments regarding this proposal. Comments should refer to the proposal by name and/or OMB Control Number and should be sent to: HUD Desk Officer, Office of Management and Budget, New Executive Office Building, Washington, DC 20503; fax:202-395-5806, Email:
Colette Pollard, Reports Management Officer, QMAC, Department of Housing and Urban Development, 451 7th Street SW, Washington, DC 20410; email
Copies of available documents submitted to OMB may be obtained from Ms. Pollard.
This notice informs the public that HUD is seeking approval from OMB for the information collection described in Section A.
The
This notice is soliciting comments from members of the public and affected parties concerning the collection of information described in Section A on the following:
(1) 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;
(2) The accuracy of the agency's estimate of the burden of the proposed collection of information;
(3) Ways to enhance the quality, utility, and clarity of the information to be collected; and
(4) Ways to minimize the burden of the collection of information on those who are to respond: including through the use of appropriate automated collection techniques or other forms of information technology,
HUD encourages interested parties to submit comment in response to these questions.
Section 3507 of the Paperwork Reduction Act of 1995, 44 U.S.C. Chapter 35.
Office of the Assistant Secretary for Administration, HUD.
Notice of redelegation of authority.
Through this notice, the Assistant Secretary for Administration redelegates to the General Deputy Assistant Secretary for Administration concurrent authority, vested in or delegated or assigned to the Assistant Secretary for Administration, including authority and responsibility for the coordination, management and
This redelegation of authority is applicable upon signature.
John B. Shumway, Assistant General Counsel for Administrative Law, Office of General Counsel, Department of Housing and Urban Development, 451 7th Street SW, Room 9262, Washington, DC 20410-0500, telephone number 202-402-5190. (This is not a toll-free number.) Individuals with speech or hearing impairments may access this number through TTY by calling 1-800-877-8339.
In January 2018, the Deputy Secretary delegated authority to the Assistant Secretary for Administration, which was published in the
The Assistant Secretary for Administration hereby redelegates to the General Deputy Assistant Secretary for Administration the concurrent authority to coordinate, manage and supervise the activities of the following offices and functions:
1.
2.
3.
The General Deputy Assistant Secretary for Administration is authorized to redelegate to employees of HUD any of the authority delegated under Section A above.
This delegation does not supersede the previous delegation of authority from the Deputy Secretary to the Assistant Secretary of Administration, which was published in the
Section 7(d), Department of Housing and Urban Development Act (42 U.S.C. 3535(d)).
Bureau of Safety and Environmental Enforcement, Interior.
Notice of information collection; request for comment.
In accordance with the Paperwork Reduction Act of 1995, the Bureau of Safety and Environmental Enforcement (BSEE) proposes to renew an information collection.
Interested persons are invited to submit comments on or before June 18, 2018.
Send your comments on this information collection request (ICR) by either of the following methods listed below:
• Electronically go to
• Email
To request additional information about this ICR, contact Kelly Odom by email at
In accordance with the Paperwork Reduction Act of 1995, we provide the general public and other Federal agencies with an opportunity to comment on new, proposed, revised, and continuing collections of information. This helps us assess the impact of our information collection
We are soliciting comments on the proposed ICR that is described below. We are especially interested in public comments addressing the following issues: (1) Is the collection necessary to the proper functions of BSEE; (2) Will this information be processed and used in a timely manner; (3) Is the estimate of burden accurate; (4) How might BSEE enhance the quality, utility, and clarity of the information to be collected; and (5) How might BSEE minimize the burden of this collection on the respondents, including through the use of information technology.
Comments that you submit in response to this notice are a matter of public record. We will include or summarize each comment in our request to OMB to approve this ICR. 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. While you can ask us in your comment to withhold your personal identifying information from public review, we cannot guarantee that we will be able to do so.
The BSEE uses the information to make decisions on the economic viability of leases requesting a suspension or elimination of royalty or net profit share. These decisions have enormous monetary impact on both the lessee and the Federal Government. Royalty relief can lead to increased production of natural gas and oil, creating profits for lessees, and royalty and tax revenues for the Federal Government that they might not otherwise receive. We could not make an informed decision without the collection of information required by 30 CFR part 203.
An agency may not conduct or sponsor and a person is not required to respond to a collection of information unless it displays a currently valid OMB control number.
The authority for this action is the Paperwork Reduction Act of 1995 (44 U.S.C. 3501
Bureau of Safety and Environmental Enforcement, Interior.
Notice of information collection; request for comment.
In accordance with the Paperwork Reduction Act of 1995, the Bureau of Safety and Environmental Enforcement (BSEE) proposes to renew an information collection.
Interested persons are invited to submit comments on or before June 18, 2018.
Send your comments on this information collection request (ICR) by either of the following methods listed below:
• Electronically go to
• Email
To request additional information about this ICR, contact Nicole Mason by email at
In accordance with the Paperwork Reduction Act of 1995, we provide the general public and other Federal agencies with an opportunity to comment on new, proposed, revised, and continuing collections of information. This helps us assess the impact of our information collection requirements and minimize the public's reporting burden. It also helps the public understand our information collection requirements and provide the requested data in the desired format.
We are soliciting comments on the proposed ICR that is described below. We are especially interested in public comments addressing the following issues: (1) Is the collection necessary to the proper functions of BSEE; (2) Will this information be processed and used in a timely manner; (3) Is the estimate of burden accurate; (4) How might BSEE enhance the quality, utility, and clarity of the information to be collected; and (5) How might BSEE minimize the burden of this collection on the respondents, including through the use of information technology.
Comments that you submit in response to this notice are a matter of public record. We will include or summarize each comment in our request to OMB to approve this ICR. 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. While you can ask us in your comment to withhold your personal identifying
The BSEE will use the information collected under subpart O regulations to ensure that workers in the OCS are properly trained with the necessary skills to perform their jobs in a safe and pollution-free manner.
In some instances, we may conduct oral interviews of offshore employees to evaluate the effectiveness of a company's training program. The oral interviews are used to gauge how effectively the companies are implementing their own training program.
An agency may not conduct or sponsor and a person is not required to respond to a collection of information unless it displays a currently valid OMB control number.
The authority for this action is the Paperwork Reduction Act of 1995 (44 U.S.C. 3501
United States International Trade Commission.
Institution of investigation and notice of opportunity to provide written comments.
Following receipt on April 6, 2018, of a request from the U.S. Trade Representative (USTR), the Commission instituted investigation No. U.S.-Korea FTA-103-031,
May 1, 2018: Deadline for filing written submissions.
June 1, 2018: Transmittal of Commission report to USTR.
All Commission offices, including the Commission's hearing rooms, are located in the United States International Trade Commission Building, 500 E Street SW, Washington, DC. All written submissions should be addressed to the Secretary, United States International Trade Commission, 500 E Street SW, Washington, DC 20436. The public record for this investigation may be viewed on the Commission's electronic docket (EDIS) at
Project Leader Jeff Horowitz (202-205-2750 or
In the request letter, the USTR asked that the Commission provide advice on the probable economic effect of the modifications on U.S. trade under the FTA and on domestic producers of the affected articles. He asked that the Commission provide its advice at the earliest possible date but no later than eight weeks from receipt of the request. He also asked that the Commission issue, as soon as possible thereafter, a public version of its report with any confidential business information deleted.
The products identified in the proposal are motor vehicles for the transport of goods provided for in subheadings 8704.21.00, 8704.22.50, 8704.23.00, 8704.31.00, 8704.32.00, and 8704.90.00 of the U.S. Harmonized Tariff Schedule. The request letter and the proposed modification are available on the Commission's website at
The Commission may include some or all of the confidential business information submitted in the course of this investigation in the report it sends to the USTR. Additionally, all information, including CBI, submitted in this investigation may be disclosed to and used: (i) By the Commission, its employees and Offices, and contract personnel (a) for developing or maintaining the records of this or a related proceeding, or (b) in internal investigations, audits, reviews, and evaluations relating to the programs, personnel, and operations of the Commission including under 5 U.S.C. Appendix 3; or (ii) by U.S. government employees and contract personnel for cybersecurity purposes. The Commission will not otherwise disclose any confidential business information in a manner that would reveal the operations of the firm supplying the information.
By order of the Commission.
Notice of application.
Registered bulk importers of the affected basic classes, and applicants therefore, may file written comments on or objections to the issuance of the proposed registration on or before May 17, 2018. Such persons may also file a written request for a hearing on the application on or before May 17, 2018.
Written comments should be sent to: Drug Enforcement Administration, Attention: DEA Federal Register Representative/DRW, 8701 Morrissette Drive, Springfield, Virginia 22152. All requests for hearing must be sent to: Drug Enforcement Administration, Attn: Administrator, 8701 Morrissette Drive, Springfield, Virginia 22152. All request for hearing should also be sent to: (1) Drug Enforcement Administration, Attn: Hearing Clerk/LJ, 8701 Morrissette Drive, Springfield, Virginia 22152; and (2) Drug Enforcement Administration, Attn: DEA Federal Register Representative/DRW, 8701 Morrissette Drive, Springfield, Virginia 22152. Comments and requests for hearings on applications to import narcotic raw material are not appropriate. 72 FR 3417, (January 25, 2007)
The Attorney General has delegated his authority under the Controlled Substances Act to the Administrator of the Drug Enforcement Administration (DEA), 28 CFR 0.100(b). Authority to exercise all necessary functions with respect to the promulgation and implementation of 21 CFR part 1301, incident to the registration of manufacturers, distributors, dispensers, importers, and exporters of controlled substances (other than final orders in connection with suspension, denial, or revocation of registration) has been redelegated to the Assistant Administrator of the DEA Diversion Control Division (“Assistant Administrator”) pursuant to section 7 of 28 CFR part 0, appendix to subpart R.
In accordance with 21 CFR 1301.34(a), this is notice that on March 14, 2018, Clinical Supplies Management Holdings, Inc., 342 42nd Street South, Fargo, ND 58103 applied to be registered as an importer of the following basic classes of controlled substances:
The company plans to import analytical reference standards for distribution to its customers for research and analytical purposes. Placement of these drug codes onto the company's registration does not translate into automatic approval of subsequent permit applications to import controlled substances. Approval of permit applications will occur only when the registrant's business activity is consistent with what is authorized under 21 U.S.C. 952(a)(2). Authorization will not extend to the import of FDA approved or non-approved finished dosage forms for commercial sale.
Drug Enforcement Administration, Department of Justice.
30-Day Notice.
The Department of Justice (DOJ), Drug Enforcement Administration (DEA), will be submitting the following information collection request to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act of 1995. The proposed information collection was previously published in the
Comments are encouraged and will be accepted for 30 days until May 17, 2018.
If you have comments on the estimated public burden or associated response time, suggestions, or need a copy of the proposed information collection instrument with instructions or additional information, please contact Michael J. Lewis, Diversion Control Division, Drug Enforcement Administration; Mailing Address: 8701 Morrissette Drive, Springfield, Virginia 22152; Telephone: (202) 598-6812 or sent to
Written comments and suggestions from the public and affected agencies concerning the proposed collection of information are encouraged. Your comments should address one or more of the following four points:
1.
2.
4.
5.
6.
If additional information is required please contact: Melody Braswell, Department Clearance Officer, United States Department of Justice, Justice Management Division, Policy and Planning Staff, Two Constitution Square, 145 N Street NE, Suite 3E.405B, Washington, DC 20530.
Disability Rights Section, Civil Rights Division, U.S. Department of Justice.
60 Day notice.
The Department of Justice, Civil Rights Division, Disability Rights Section, is submitting the following information collection request to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act of 1995.
The Department of Justice encourages public comment and will accept input until June 18, 2018.
Comments received after the close of the comment period are disfavored and will be marked “late.” The Department is not required to consider late comments.
If you have additional comments, especially on the estimated public burden or associated response time, suggestions, or need a copy of the proposed information collection instrument with instructions or additional information, please contact Rebecca Bond, Chief, U.S. Department of Justice, Civil Rights Division, Disability Rights Section, NYA, 950 Pennsylvania Avenue NW, Washington, DC 20530,
Written comments and suggestions from the public and affected agencies concerning the proposed collection of information are encouraged. Your comments should address one or more of the following four points:
1.
2.
3.
4.
5.
6.
Drug Enforcement Administration, Department of Justice.
30-Day notice.
The Department of Justice (DOJ), Drug Enforcement Administration (DEA), will be submitting the following information collection request to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act of 1995. The proposed information collection was previously published in the
Comments are encouraged and will be accepted for 30 days until May 17, 2018.
If you have comments on the estimated public burden or associated response time, suggestions, or need a copy of the proposed information collection instrument with instructions or additional information, please contact Michael J. Lewis, Diversion Control Division, Drug Enforcement Administration; Mailing Address: 8701 Morrissette Drive, Springfield, Virginia
Written comments and suggestions from the public and affected agencies concerning the proposed collection of information are encouraged. Your comments should address one or more of the following four points:
1.
2.
4.
5.
6.
11:00 a.m. Tuesday, April 24, 2018
U.S. Parole Commission, 90 K Street NE, 3rd Floor, Washington, DC.
Open.
Approval of February 13, 2018 minutes; Reports from the Vice Chairman, Commissioners and Senior Staff.
Jacqueline Graham, Staff Assistant to the Chairman, U.S. Parole Commission, 90 K Street NE, 3rd Floor, Washington, DC 20530, (202) 346-7010.
12:00 a.m., Tuesday, April 24, 2018.
U.S. Parole Commission, 90 K Street NE, 3rd Floor, Washington, DC.
Closed.
Determination on ONE original jurisdiction cases.
Jacqueline Graham, Staff Assistant to the Chairman, U.S. Parole Commission, 90 K Street NE, 3rd Floor, Washington, DC. 20530, (202) 346-7001.
National Science Foundation.
Notice and request for comments.
Under the Paperwork Reduction Act of 1995, and as part of its continuing effort to reduce paperwork and respondent burden, the National Science Foundation (NSF) is inviting the general public or other Federal agencies to comment on this proposed continuing information collection. NSF will publish periodic summaries of the proposed projects.
Written comments on this notice must be received by June 18, 2018, to be assured consideration. Comments received after that date will be considered to the extent practicable. Send comments to address below.
Suzanne H. Plimpton, Reports Clearance Officer, National Science Foundation, 2415 Eisenhower Avenue, Alexandria, Virginia 22314; telephone (703) 292-7556; or send email to
ERCs conduct world-class research with an engineered systems perspective that integrates materials, devices, processes, components, control algorithms and/or other enabling elements to perform a well-defined function. These systems provide a unique academic research and education experience that involves integrative complexity and technological realization. The complexity of the systems perspective includes the factors associated with its use in industry, society/environment, or the human body.
ERCs enable and foster excellent education, integrate research and education, speed knowledge/technology transfer through partnerships between academe and industry, and prepare a more competitive future workforce. ERCs capitalize on diversity through participation in center activities and demonstrate leadership in the involvement of groups underrepresented in science and engineering.
Centers are required to submit annual reports on progress and plans, which will be used as a basis for performance review and determining the level of continued funding. To support this review and the management of a Center, ERCs also are required to submit management and performance indicators annually to NSF via a data collection website that is managed by a technical assistance contractor. These indicators are both quantitative and descriptive and may include, for example, the characteristics of center personnel and students; sources of cash and in-kind support; expenditures by operational component; characteristics of industrial and/or other sector participation; research activities; education activities; knowledge transfer activities; patents, licenses; publications; degrees granted to students involved in Center activities; descriptions of significant advances and other outcomes of the ERC effort. Such reporting requirements will be included in the cooperative agreement which is binding between the academic institution and the NSF.
Each Center's annual report will address the following categories of activities: (1) Vision and impact, (2) strategic plan, (3) research program, (4) innovation ecosystem and industrial collaboration, (5) education, (6) infrastructure (leadership, management, facilities, diversity) and (7) budget issues.
For each of the categories the report will describe overall objectives for the year, progress toward center goals, problems the Center has encountered in making progress towards goals and how they were overcome, plans for the future and anticipated research and other barriers to overcome in the following year, and specific outputs and outcomes.
The ACRS Subcommittee on Reliability and Probabilistic Risk Assessment will hold a meeting on May 2, 2018 at 11545 Rockville Pike, Room T-2B1, Rockville, Maryland 20852.
The meeting will be open to public attendance with the exception of portions that will be closed to protect information that is proprietary pursuant to 5 U.S.C. 552b(c)(4). The agenda for the subject meeting shall be as follows:
The Subcommittee will hear presentations by and hold discussions with the NRC staff and other interested persons on the progress of the Level 3
Members of the public desiring to provide oral statements and/or written comments should notify the Designated Federal Official (DFO), Christiana Lui (Telephone 301-415-2492 or Email
Detailed meeting agendas and meeting transcripts are available on the NRC website at
If attending this meeting, please enter through the One White Flint North building, 11555 Rockville Pike, Rockville, Maryland 20852. After registering with Security, please contact Mr. Theron Brown (Telephone 301-415-6702) to be escorted to the meeting room.
The ACRS Subcommittee on Planning and Procedures will hold a meeting on May 2, 2018, 11545 Rockville Pike, Room T-2B3, Rockville, Maryland 20852.
The meeting will be open to public attendance.
The agenda for the subject meeting shall be as follows:
The Subcommittee will discuss proposed ACRS activities and related matters. The Subcommittee will gather information, analyze relevant issues and facts, and formulate proposed positions and actions, as appropriate, for deliberation by the Full Committee.
Members of the public desiring to provide oral statements and/or written comments should notify the Designated Federal Official (DFO), Quynh Nguyen (Telephone 301-415-5844 or Email:
Information regarding changes to the agenda, whether the meeting has been canceled or rescheduled, and the time allotted to present oral statements can be obtained by contacting the identified DFO. Moreover, in view of the possibility that the schedule for ACRS meetings may be adjusted by the Chairman as necessary to facilitate the conduct of the meeting, persons planning to attend should check with the DFO if such rescheduling would result in a major inconvenience.
If attending this meeting, please enter through the One White Flint North building, 11555 Rockville Pike, Rockville, Maryland 20852. After registering with Security, please contact Mr. Theron Brown at 301-415-6702 to be escorted to the meeting room.
2:30 p.m. on Thursday, April 19, 2018.
Closed Commission Hearing, Room 10800.
This meeting will be closed to the public.
Commissioners, Counsel to the Commissioners, the Secretary to the Commission, and recording secretaries will attend the closed meeting. Certain staff members who have an interest in the matters also may be present.
The General Counsel of the Commission, or his designee, has certified that, in his opinion, one or more of the exemptions set forth in 5 U.S.C. 552b(c)(3), (5), (6), (7), (8), 9(B) and (10) and 17 CFR 200.402(a)(3), (a)(5), (a)(6), (a)(7), (a)(8), (a)(9)(ii) and (a)(10), permit consideration of the scheduled matters at the closed meeting.
Commissioner Jackson, as duty officer, voted to consider the items listed for the closed meeting in closed session.
The subject matters of the closed meeting will be:
Institution of injunctive actions;
Institution and settlement of administrative proceedings;
Litigation matter; and
Other matters relating to enforcement proceedings.
At times, changes in Commission priorities require alterations in the scheduling of meeting items.
For further information and to ascertain what, if any, matters have been added, deleted or postponed; please contact Brent J. Fields from the Office of the Secretary at (202) 551-5400.
On February 9, 2018, Nasdaq PHLX LLC (“Phlx” or the “Exchange”) filed with the Securities and Exchange Commission (“Commission”), pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (“Act”)
As described more fully in the Notice, the Exchange proposes to amend Phlx Rule 1098 to adopt protections that will prevent the execution of a butterfly spread
The Phlx states that the proposal is responsive to member input and will provide members with additional functionality that will assist them in managing risk.
After careful review, the Commission finds that the proposed rule change is consistent with the requirements of the Act and the rules and regulations thereunder applicable to a national securities exchange.
The Commission believes that the Butterfly Spread Protection and the Box Spread Protection will help market participants mitigate risk by preventing the execution of butterfly and box spreads at prices that are outside of specified minimum and maximum values. The Commission notes that the Phlx has indicated that the protections are responsive to input from Phlx members.
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
Notice is hereby given that pursuant to the Paperwork Reduction Act of 1995 (“PRA”) (44 U.S.C. 3501
Rule 15g-4 requires brokers and dealers effecting transactions in penny stocks for or with customers to disclose the amount of compensation received by the broker-dealer in connection with the transaction. The purpose of the rule is to increase the level of disclosure to investors concerning penny stocks generally and specific penny stock transactions.
The Commission estimates that approximately 195 broker-dealers will spend an average of 87 hours annually to comply with this rule. Thus, the total compliance burden is approximately 16,965 burden-hours per year.
Written comments are invited on: (a) Whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility; (b) the accuracy of the agency's estimates of the burden of the proposed collection of information; (c) ways to enhance the quality, utility, and clarity of the information to be collected; and (d) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or other forms of information technology. Consideration will be given to comments and suggestions submitted in writing within 60 days of this publication.
An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information under the PRA unless it displays a currently valid OMB control number.
Please direct your written comments to: Pamela Dyson, Acting Director/Chief Information Officer, Securities and Exchange Commission, c/o Remi Pavlik-Simon, 100 F Street NE, Washington, DC 20549 or send an email to
Notice is hereby given that, pursuant to the Paperwork Reduction Act of 1995 (44 U.S.C. 3501
Rule 6e-2 (17 CFR 270.6e-2) under the Investment Company Act of 1940 (“Act”) (15 U.S.C. 80a) is an exemptive rule that provides separate accounts formed by life insurance companies to fund certain variable life insurance products, exemptions from certain provisions of the Act, subject to conditions set forth in the rule.
Rule 6e-2 provides a separate account with an exemption from the registration provisions of section 8(a) of the Act if the account files with the Commission Form N-6EI-1 (17 CFR 274.301), a notification of claim of exemption.
The rule also exempts a separate account from a number of other sections of the Act, provided that the separate account makes certain disclosure in its registration statements (in the case of those separate account that elect to register), reports to contract holders, proxy solicitations, and submissions to state regulatory authorities, as prescribed by the rule.
Since 2008, there have been no filings of Form N-6EI-1 by separate accounts. Therefore, there has been no cost or burden to the industry since that time. The Commission requests authorization to maintain an inventory of one burden hour for administrative purposes.
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 control number.
The public may view the background documentation for this information collection at the following website,
Pursuant to Section 19(b)(1)
The Exchange proposes to amend the NYSE Arca Equities Fees and Charges (“Fee Schedule”) to (i) revise the requirements to qualify for the Step-Up Tier; (ii) adopt a new pricing tier, BBO Setter Tier; (iii) delete the Tape A and Tape C Tier; (iv) eliminate the credits associated with indications of interest (“IOIs”); (v) delete obsolete language related to an Exchange Traded Product (“ETP”) Incentive Program; and (vi) modify the credit the Exchange provides for orders with the Self Trade Prevention (“STP”) Cancel Both (“STPC”) and STP Decrement and Cancel (“STPD”) Modifiers. The Exchange proposes to implement the fee changes effective April 2, 2018. The proposed rule change is available on the Exchange's website at
In its filing with the Commission, the self-regulatory organization 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 those statements may be examined at the places specified in Item IV below. The Exchange has prepared summaries, set forth in sections A, B, and C below, of the most significant parts of such statements.
The Exchange proposes to amend the Fee Schedule, as described below, to (i) revise the requirements for the Step-Up Tier; (ii) adopt a new pricing tier, BBO Setter Tier; (iii) delete the Tape A and Tape C Tier; (iv) eliminate the credits associated with IOIs; (v) delete obsolete language related to an ETP Incentive Program; and (vi) modify the credit the Exchange provides for orders with the STPC and STPD Modifiers. The Exchange proposes to implement the fee changes on April 2, 2018.
In September 2016, the Exchange filed a proposed rule change to adopt a new Step-Up pricing tier that was intended to incentivize ETP Holders and Market Makers to increase order flow and provide additional liquidity.
The Step-Up Tier has not encouraged ETP Holders and Market Makers to increase their activity to qualify for this pricing tier as significantly as the Exchange had anticipated that it would. As a result, the Exchange proposes to revise the current requirements to qualify for the Step-Up Tier. As proposed, ETP Holders and Market Makers would qualify for the Step-Up Tier if they directly execute providing average daily volume per month of 0.50% or more but less than 0.70% of the US CADV, and directly execute providing ADV that is an increase of no less than 0.10% of US CADV for that month over the ETP Holder's or Market Maker's providing ADV in Q1 2018. ETP Holders and Market Makers that qualify for the Step-Up Tier would receive a credit of $0.0030 per share for orders that provide displayed liquidity to the Book in Tape A Securities, $0.0023 per share for orders that provide displayed liquidity to the Book in Tape B Securities, and $0.0031 per share for orders that provide displayed liquidity in Tape C Securities.
The goal of the Step-Up Tier remains the same,
The Exchange proposes a new pricing tier—BBO Setter Tier—for securities with a per share price of $1.00 or above.
As proposed, a new BBO Setter Tier credit of $0.0004 per share for orders that set a new NYSE Arca BBO in Tape A and Tape C Securities and $0.0002 per share for orders that set a new NYSE Arca BBO in Tape B Securities would apply to ETP Holders and Market Makers that directly execute providing ADV per month of 0.70% or more of the US CADV, and provided that an ETP ID
For example, assume an ETP Holder or Market Maker qualifies for the Tape C Tier 1 credit of $0.0032 per share for orders that provide liquidity to the Book. Assume further that the same ETP Holder or Market Maker also qualifies for the Tape C Tier 2 incremental credit of $0.0002 per share. Pursuant to the Tape C Tier 2 pricing tier, the ETP Holder or Market Maker's credit cannot exceed $0.0033 per share. In this example, the ETP Holder or Market Maker's credit would be capped at $0.0033 per share. Assume further that the ETP Holder or Market Maker has an ETP ID that qualifies for the proposed BBO Setter Tier, which would provide an additional credit of $0.0004 per share to the qualifying ETP ID, and combined with the ETP Holder or Market Maker's credit of $0.0033 per share, the ETP Holder or Market Maker in this example would receive a total credit of $0.0037 per share for orders that set a new NYSE Arca BBO. The ETP ID's orders that do not set a new NYSE Arca BBO would not receive the proposed BBO Setter Tier credit.
In July 2017, the Exchange filed a proposed rule change to adopt a new pricing tier—Tape A and Tape C Tier—as an incentive for ETP Holders and Market Makers to provide liquidity in Tape A and Tape C Securities.
In August 2008, the Exchange filed a proposed rule change to adopt credits that apply to indications of interest (“IOIs”) submitted by ETP Holders that result in routed and executed orders.
The Exchange proposes to amend the Fee Schedule to reflect the termination of a pilot program designed to incentivize quoting and trading in Exchange Traded Products (“ETPs”) and to add competition among existing qualified Market Makers
The Exchange currently provides STP Modifiers that allow ETP Holders entering orders to elect to prevent those orders from executing against other orders entered on the Exchange by the
On incoming orders marked with the STPD Modifier, both orders are cancelled back to the ETP Holder if the orders are equivalent in size. If the orders are not equivalent in size, the equivalent size is cancelled back to the ETP Holder and the larger order is decremented by the size of the smaller order with the balance remaining on the NYSE Arca Book. For billing purposes, only the size of the portion of the orders cancelled back to the ETP Holder is charged or credited. On incoming orders marked with the STPC Modifier, the entire size of both orders is cancelled back to ETP Holder. However, for billing purposes, incoming orders marked with the STPC Modifier are only charged or credited up to the equivalent size of both orders.
The Exchange believes that the proposed rule change is consistent with Section 6(b) of the Act,
The Exchange believes that the proposed revised Step-Up Tier is equitable because it is open to all ETP Holders and Market Makers on an equal basis and provides credits that are reasonably related to the value to an exchange's market quality associated with higher volumes. As stated above, the Exchange believes that the Step-Up Tier is intended to incentivize market participants to increase the orders sent directly to NYSE Arca and therefore provide liquidity that supports the quality of price discovery and promotes market transparency. Moreover, the addition of the Step-Up Tier would benefit market participants whose increased order flow provides meaningful added levels of liquidity thereby contributing to the depth and market quality on the Exchange. The Exchange believes that the proposed change is equitable and not unfairly discriminatory because providing incentives for orders that are executed on a registered national securities exchange would contribute to investors' confidence in the fairness of their transactions and would benefit all investors by deepening the Exchange's liquidity pool, supporting the quality of price discovery, promoting market transparency and improving investor protection.
The Exchange believes that the proposed NBBO Setter Tier is reasonable because it provides an opportunity for ETP Holders and Market Makers that qualify to receive an incremental per share credit if the ETP ID associated with an ETP Holder or Market Maker meets certain trading qualifications and establishes the BBO on the Exchange.
The Exchange believes that it is reasonable to delete obsolete pricing tiers from the Fee Schedule because ETP Holders and Market Makers have not increased their activity to qualify for the Tape A and Tape C Tier as significantly as the Exchange anticipated they would. The Exchange believes that it is equitable and not unfairly discriminatory to eliminate the Tape A and Tape C Tier because, as proposed, such pricing tier would be eliminated entirely—ETP Holders and Market Makers would no longer be able to qualify for this pricing tier. This aspect of the proposed rule change would result in the removal of obsolete text from the Fee Schedule and therefore add greater clarity to the Fee Schedule.
The Exchange believes that it is reasonable to eliminate the credits that apply to IOIs submitted by ETP Holders that result in routed and executed orders because the IOI Credits have not incentivized ETP Holders to participate in the IOI program as anticipated by the Exchange. The Exchange believes that it is equitable and not unfairly discriminatory to eliminate the IOI Credits because, as proposed, such credits would be eliminated entirely—ETP Holders would no longer be able to qualify for such credits.
The Exchange believes it is equitable, reasonable and not unfairly discriminatory to remove reference to the ETP Pilot from the Fee Schedule because the ETP Pilot expired in July 2017 and deleting rules that no longer apply will bring clarity to the Fee Schedule. The Exchange believes the proposed rule change will make the Fee Schedule clearer and eliminate potential investor confusion, thereby removing impediments to and perfecting the mechanism of a free and open market and a national market system, and in
The Exchange believes it is reasonable to modify the credit provided to an ETP Holder's resting STP order that is returned to the ETP Holder. The Exchange believes standardizing the fees and credits applicable to orders marked with the STPC and STPD Modifier would encourage ETP Holders to increase their utilization of the STP functionality in order to better manage order flow and prevent undesirable or unexpected executions with themselves. The Exchange further believes the proposed increased credit is equitable and not unfairly discriminatory because it would be available to all similarly situated ETP Holders on an equal basis.
For the foregoing reasons, the Exchange believes that the proposal is consistent with the Act.
In accordance with Section 6(b)(8) of the Act,
The Exchange notes that it operates in a highly competitive market in which market participants can readily favor competing venues if they deem fee levels at a particular venue to be excessive or rebate opportunities available at other venues to be more favorable. In such an environment, the Exchange must continually adjust its fees and rebates to remain competitive with other exchanges and to attract order flow to the Exchange. Because competitors are free to modify their own fees and credits in response, and because market participants may readily adjust their order routing practices, the Exchange believes that the degree to which fee changes in this market may impose any burden on competition is extremely limited. As a result of all of these considerations, the Exchange does not believe that the proposed changes will impair the ability of ETP Holders or competing order execution venues to maintain their competitive standing in the financial markets.
No written comments were solicited or received with respect to the proposed rule change.
The foregoing rule change is effective upon filing pursuant to Section 19(b)(3)(A)
At any time within 60 days of the filing of such 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 under Section 19(b)(2)(B)
Interested persons are invited to submit written data, views, and arguments concerning the foregoing, including whether the proposed rule change is consistent with the Act. Comments may be submitted by any of the following methods:
• Use the Commission's internet comment form (
• Send an email to
• Send paper comments in triplicate to Brent J. Fields, Secretary, Securities and Exchange Commission, 100 F Street NE, Washington, DC 20549-1090.
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
JP Rail, Inc. d/b/a Southern Railroad Company of New Jersey (SRNJ), a Class III rail carrier, has filed a verified notice of exemption under 49 CFR 1150.41 to lease from Consolidated Rail Corporation (Conrail),
According to SRNJ, it is entering into a lease agreement and an interchange agreement with Conrail, which would allow SRNJ to operate over the Line and interchange railcars with Conrail at an interchange track located in the City of Woodbury.
SRNJ certifies that its projected revenues will not exceed those that would qualify it as a Class III rail carrier and will not exceed $5 million. SRNJ states that the agreement does not involve a provision or agreement that may limit future interchange with a third party connecting carrier.
The transaction may be consummated on or after May 2, 2018, the effective date of the exemption (30 days after the verified notice was filed).
If the verified notice contains false or misleading information, the exemption is void ab initio. Petitions to revoke the exemption under 49 U.S.C. 10502(d) may be filed at any time. The filing of a petition to revoke will not automatically stay the effectiveness of the exemption. Petitions to stay must be filed no later than April 24, 2018 (at least seven days before the exemption becomes effective).
An original and 10 copies of all pleadings, referring to Docket No. FD 36172, must be filed with the Surface Transportation Board, 395 E Street SW, Washington, DC 20423-0001. In addition, a copy must be served on John K. Fiorilla, Capehart & Scatchard, P.A., 8000 Midlantic Drive, Suite 300S, Mount Laurel, NJ 08054.
According to SRNJ, this action is exempt from environmental review under 49 CFR 1105.6(c) and exempt from historic review under 49 CFR 1105.8(b).
Board decisions and notices are available on our website at “
By the Board, Scott M. Zimmerman, Acting Director, Office of Proceedings.
Federal Aviation Administration (FAA), U.S. Department of Transportation (DOT).
Eighty Eighth RTCA SC-147 Plenary Session Joint With EUROCAE WG-75.
The FAA is issuing this notice to advise the public of a meeting of Eighty Eighth RTCA SC-147 Plenary Session Joint with EUROCAE WG-75.
The meeting will be held May 18, 2018 9:00 a.m.-3:30 p.m.
The meeting will be held at: RTCA Headquarters, 1150 18th Street NW, Suite 910, Washington, DC 20036.
Al Secen at
Pursuant to section 10(a)(2) of the Federal Advisory Committee Act (Pub. L. 92-463, 5 U.S.C., App.), notice is hereby given for a meeting of the Eighty Eighth RTCA SC-147 Plenary Session Joint with EUROCAE WG-75. The agenda will include the following:
Attendance is open to the interested public but limited to space availability. With the approval of the chairman, members of the public may present oral statements at the meeting. Persons wishing to present statements or obtain information should contact the person listed in the
Federal Highway Administration (FHWA), DOT.
Notice and request for comments.
In compliance with the Paperwork Reduction Act (PRA) of
Please submit comments by May 17, 2018.
You may submit comments identified by DOT Docket ID 2018-0026 by any of the following methods:
Steven Jessberger, 202-366-5052, Federal Highway Administration, Department of Transportation, Office of Highway Policy Information, 1200 New Jersey Avenue SE, Washington, DC 20590, Monday through Friday, except Federal holidays.
The Paperwork Reduction Act of 1995; 44 U.S.C. Chapter 35, as amended; and 49 CFR 1.48.
Federal Highway Administration (FHWA), DOT.
Notice and request for comments.
In compliance with the Paperwork Reduction Act (PRA) of 1995, this notice announces that FHWA will submit the collection of information described below to the Office of Management and Budget (OMB) for review and comment. The
Please submit comments by May 17, 2018.
You may submit comments identified by DOT Docket ID 2014-0028 by any of the following methods:
Samantha Lubkin, 202-366-1575, Office of Bridges and Structures, Federal Highway Administration, Department of Transportation, 1200 New Jersey
The Paperwork Reduction Act of 1995; 44 U.S.C. Chapter 35, as amended; and 49 CFR 1.48.
Federal Highway Administration (FHWA), DOT.
Notice and request for comments.
In compliance with the Paperwork Reduction Act (PRA) of 1995, this notice announces that FHWA will submit the collection of information described below to the Office of Management and Budget (OMB) for review and comment. The
Please submit comments by May 17, 2018.
You may submit comments identified by DOT Docket ID 2014-0027 by any of the following methods:
The Paperwork Reduction Act of 1995; 44 U.S.C. Chapter 35, as amended; and 49 CFR 1.48.
Federal Highway Administration (FHWA), Department of Transportation (DOT).
Notice of limitation on claims for judicial review of actions by FHWA and other Federal agencies.
This notice announces actions taken by the FHWA and other Federal agencies that are final. The actions relate to various proposed highway projects in the State of Colorado. Those actions grant licenses, permits, and approvals for the projects.
By this notice, the FHWA is advising the public of final agency actions subject to 23 U.S.C. 139(l)(1). A claim seeking judicial review of the Federal agency actions on any of the listed highway projects will be barred unless the claim is filed on or before September 14, 2018. If the Federal law that authorizes judicial review of a claim provides a time period of less than 150 days for filing such claim, then that shorter time period still applies.
Stephanie Gibson, Environmental Program Manager, Federal Highway Administration Colorado Division, 12300 W Dakota Avenue, Suite 180, Lakewood, Colorado 80228, telephone: 720-963-3013, email:
Notice is hereby given that the FHWA and other Federal agencies have taken final agency actions 23 U.S.C. 139(l)(1) by issuing licenses, permits, and approvals for the highway projects in the State of Colorado that are listed below. The actions by the Federal agencies on a project, and the laws under which such actions were taken, are described in the environmental assessment (EA) or environmental impact statement (EIS) issued in connection with the project and in other key project documents. The EA or EIS, and other key documents for the listed projects are available by contacting the FHWA or the Colorado Department of Transportation at the addresses provided above. The EA, Finding of No Significant Impact (FONSI), Final EIS, and Record of Decision (ROD) documents can be viewed and downloaded from the websites listed below.
This notice applies to all Federal agency decisions on each project as of the issuance date of this notice and all laws under which such actions were taken. This notice does not, however, alter or extend the limitation period of 150 days for challenges to final agency actions subject to previous notices published in the
This notice applies to all Federal agency decisions, actions, approvals, licenses and permits on the project as of the issuance date of this notice, including but not limited to those arising under the following laws, as amended:
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The projects subject to this notice are:
1. I-76 and Bridge Street Interchange EA and FONSI. Project Location: I-76 and Bridge Street, Brighton, Colorado. Project reference number: 0761-202. Project overview: The project would construct a new interchange at I-76 and Bridge Street (SH 7). Project Purpose: The purpose of the project is to increase local and regional east-west connectivity, reduce the amount of travel delay through the planning horizon year of 2035, and improve traffic flow in the project area. Signed NEPA documents and permits: EA was signed January 23, 2015 and FONSI was signed July 8, 2015.
2. 6th Avenue Parkway Extension EA and FONSI. Project Location: 6th Avenue from SH 30 to E-470, Aurora, Colorado. Project overview: This project would construct the 6th Avenue Parkway extension along a new roadway alignment between State Highway (SH 30) and the 6th Avenue Parkway/E-470 Tollway (E-470) interchange Project Purpose: The purpose of this project is to enhance east-west mobility by implementing a transportation solution that will close a critical gap between SH 30 and E-470 in the regional transportation network of northeastern Aurora. Signed NEPA documents and permits: EA signed June 23, 2016 and FONSI signed December 8, 2016.
3. Martin Luther King, Jr. Boulevard Extension EA and FONSI. Project Location: Near Havana Way, between Havana Street and Peoria Street, Denver, Colorado. Project reference number: STU M320-099. Project overview: The existing Havana Way would be renamed MLK Blvd., widened to a four-lane arterial, and extended east to the Peoria Street and Fitzsimons Parkway intersection. Project Purpose: The purpose of the project is to improve an east-west arterial connection between Havana Street and Peoria Street, a distance of 1.1 miles, improving traffic congestion and reducing out-of-direction travel. Signed NEPA documents and permits: EA signed July 25, 2011 and FONSI signed October 19, 2017.
4. US 50 West, Wills Blvd. to McCulloch Blvd. (Milepost 313 to Milepost 307) EA and FONSI. Project Location: US 50 in the western part of Pueblo, Colorado. Project reference number: STA 0503-088. Project overview: The project would widen US 50 from four to six lanes, and change intersections to interchanges at US 50 at Purcell Blvd. and Pueblo Blvd. Project Purpose: The purpose of the project is to improve safety; increase mobility, such as reducing travel time, relieving traffic congestion; and improve level of service to the connecting road network. Signed NEPA documents and permits: EA signed April 21, 2016 and FONSI signed August 17, 2016.
5. North I-25 EIS and RODs. Project Location: I-25 corridor from Denver to Wellington in northern Colorado. Project reference number: IM 0253(179). Project overview: The I-25 North project is an improvements project that includes; general purpose lanes, tolled express lanes, interchange reconstruction, and multi-modal services such as: I-25 express bus, US 85 commuter bus, and commuter rail service. Project purpose: The purpose of the I-25 North project is to make improvements to provide modal alternatives, correct geometric deficiencies, improve safety, mobility and accessibility, and replace aging and obsolete infrastructure. Signed NEPA documents and permits: FEIS was signed August 19, 2011. Revised ROD1 (SH 392 to SH 14) was signed August 16, 2017. Revised ROD1 (I-25/SH 7 Interchange) was signed October 20, 2017. ROD2 (120th Avenue to SH 7) was signed September 28, 2015. ROD3 (Crossroads Boulevard) was signed June 8, 2016. ROD4 (SH 56 to SH 392) was signed April 27, 2017. ROD5 (Vine Drive/County Road 48 Bridge Replacement) was signed December 1, 2017.
6. US 50 Tier 1 Combined Final EIS and ROD. Project Location: A 150-mile-long portion of US 50 between Pueblo and the vicinity of the Colorado-Kansas state line, going through Pueblo, Otero, Bent, and Prowers Counties. Project reference number: NH 0504-037. Project overview: The Build Alternative consists of constructing a four-lane expressway on or near the existing US 50 alignment, including new alignments around ten towns to preserve their business districts and historic downtown areas. Project Purpose: The purpose of the project is to improve safety and mobility for local, regional, and long-distance users of US 50 for present and future travel demand. This will be accomplished by balancing the mobility and access needs of these users and also providing the flexibility to meet future travel demands. Signed NEPA documents and permits: The Combined Final EIS/ROD was signed on December 11, 2017.
7. Colorado State Highway 470 (C-470) Corridor, Kipling Parkway to I-25 EA and FONSI. Project Location: A 13.75-mile portion of C-470 in the southern portion of the Denver metropolitan area. Project reference number: NH 4701-103. Project overview: The project involves adding one managed, tolled express lane in each direction between I-25 and Kipling Parkway, and a second managed lane as follows: Westbound, I-25 to Lucent Boulevard, and eastbound, Broadway to I-25. The purpose of the project is to provide congestion relief, decrease travel delay, and improve corridor reliability between Kipling Parkway and I-25 on the C-470 corridor. Project Purpose: The purpose of the project is to address existing and future C-470 congestion between Kipling Parkway and I-25, reduce traveler delay, and improve travel time reliability for corridor users through the year 2035. Signed NEPA documents and permits: This statute of limitations notice applies
23 U.S.C. 139(l)(1).
Federal Motor Carrier Safety Administration (FMCSA), DOT.
Notice of renewal of exemptions; request for comments.
FMCSA announces its decision to renew exemptions for 191 individuals from its prohibition in the Federal Motor Carrier Safety Regulations (FMCSRs) against persons with insulin-treated diabetes mellitus (ITDM) from operating commercial motor vehicles (CMVs) in interstate commerce. The exemptions enable these individuals with ITDM to continue to operate CMVs in interstate commerce.
Each group of renewed exemptions were applicable on the dates stated in the discussions below and will expire on the dates stated in the discussions below. Comments must be received on or before May 17, 2018.
You may submit comments bearing the Federal Docket Management System (FDMS) Docket No. FMCSA-2011-0382; FMCSA-2011-0383; FMCSA-2013-0194; FMCSA-2014-0012; FMCSA-2014-0013; FMCSA-2015-0342; FMCSA-2015-0343; FMCSA-2016-0034 using any of the following methods:
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Ms. Christine A. Hydock, Chief, Medical Programs Division, 202-366-4001,
Under 49 U.S.C. 31136(e) and 31315, FMCSA may grant an exemption for five years if it finds “such exemption would likely achieve a level of safety that is equivalent to or greater than the level that would be achieved absent such exemption.” The statute also allows the Agency to renew exemptions at the end of the five-year period. FMCSA grants exemptions from the FMCSRs for a two-year period to align with the maximum duration of a driver's medical certification.
The physical qualification standard for drivers regarding diabetes found in 49 CFR 391.41(b)(3) states that a person is physically qualified to drive a CMV if that person has no established medical history or clinical diagnosis of diabetes mellitus currently requiring insulin for control.
The 191 individuals listed in this notice have requested renewal of their exemptions from the diabetes standard in 49 CFR 391.41(b)(3), in accordance with FMCSA procedures. Accordingly, FMCSA has evaluated these applications for renewal on their merits and decided to extend each exemption for a renewable two-year period.
Interested parties or organizations possessing information that would otherwise show that any, or all, of these drivers are not currently achieving the statutory level of safety should immediately notify FMCSA. The Agency will evaluate any adverse evidence submitted and, if safety is being compromised or if continuation of the exemption would not be consistent with the goals and objectives of 49 U.S.C. 31136(e) and 31315, FMCSA will take immediate steps to revoke the exemption of a driver.
Under 49 U.S.C. 31315(b)(1), an exemption may be granted for no longer than two years from its approval date and may be renewed upon application. In accordance with 49 U.S.C. 31136(e) and 31315, each of the 191 applicants has satisfied the renewal conditions for obtaining an exemption from the diabetes requirement (77 FR 10612; 77 FR 13686; 77 FR 20874; 77 FR 25227; 79 FR 6987; 79 FR 10612; 79 FR 14579; 79 FR 18388; 79 FR 27685; 79 FR 28590; 81 FR 10703; 81 FR 14179; 81 FR 14197; 81 FR 39318; 81 FR 40743; 81 FR 42043; 81 FR 85317). They have maintained their required medical monitoring and have not exhibited any medical issues that would compromise their ability to safely operate a CMV during the previous two-year exemption period. These factors provide an adequate basis for predicting each driver's ability to continue to drive safely in interstate commerce. Therefore, FMCSA concludes that extending the exemption for each of these drivers for a period of two years is likely to achieve a level of
In accordance with 49 U.S.C. 31136(e) and 31315, the following groups of drivers received renewed exemptions in the month of April and are discussed below:
As of April 1, 2018, and in accordance with 49 U.S.C. 31136(e) and 31315, the following 84 individuals have satisfied the renewal conditions for obtaining an exemption from the rule prohibiting drivers with ITDM from driving CMVs in interstate commerce (79 FR 6987; 79 FR 18388; 81 FR 10703; 81 FR 40743; 81 FR 85317):
The drivers were included in docket numbers FMCSA-2013-0194; FMCSA-2015-0342. Their exemptions are applicable as of April 1, 2018, and will expire on April 1, 2020.
As of April 6, 2018, and in accordance with 49 U.S.C. 31136(e) and 31315, the following eight individuals have satisfied the renewal conditions for obtaining an exemption from the rule prohibiting drivers with ITDM from driving CMVs in interstate commerce (77 FR 10612; 77 FR 20874; 81 FR 85317):
The drivers were included in docket number FMCSA-2011-0382. Their exemptions are applicable as of April 6, 2018, and will expire on April 6, 2020.
As of April 16, 2018, and in accordance with 49 U.S.C. 31136(e) and 31315, the following 89 individuals have satisfied the renewal conditions for obtaining an exemption from the rule prohibiting drivers with ITDM from driving CMVs in interstate commerce (81 FR 14179; 81 FR 14197; 81 FR 39318; 81 FR 42043):
The drivers were included in docket numbers FMCSA-2015-0343; FMCSA-2016-0034. Their exemptions are applicable as of April 16, 2018, and will expire on April 16, 2020.
As of April 27, 2018, and in accordance with 49 U.S.C. 31136(e) and 31315, the following eight individuals have satisfied the renewal conditions for obtaining an exemption from the rule prohibiting drivers with ITDM from driving CMVs in interstate commerce (77 FR 13686; 77 FR 25227; 81 FR 85317):
The drivers were included in docket number FMCSA-2011-0383. Their exemptions are applicable as of April 27, 2018, and will expire on April 27, 2020.
As of April 30, 2018, and in accordance with 49 U.S.C. 31136(e) and 31315, the following two individuals have satisfied the renewal conditions for obtaining an exemption from the rule prohibiting drivers with ITDM from driving CMVs in interstate commerce (79 FR 10612; 79 FR 14579; 79 FR 27685; 79 FR 28590; 81 FR 85317): Charles L. Bryant, (PA); Christopher P. Martin, (NH).
The drivers were included in docket numbers FMCSA-2014-0012; FMCSA-2014-0013. Their exemptions are applicable as of April 30, 2018, and will expire on April 30, 2020.
The exemptions are extended subject to the following conditions: (1) Each driver must submit a quarterly monitoring checklist completed by the treating endocrinologist as well as an annual checklist with a comprehensive medical evaluation; (2) each driver must report within two business days of occurrence, all episodes of severe hypoglycemia, significant complications, or inability to manage diabetes; also, any involvement in an accident or any other adverse event in a CMV or personal vehicle, whether or not it is related to an episode of hypoglycemia; (3) each driver must submit an annual ophthalmologist's or optometrist's report; and (4) each driver must provide a copy of the annual medical certification to the employer for retention in the driver's qualification file, or keep a copy in his/her driver's qualification file if he/she is self-employed. The driver must also have a copy of the exemption when driving, for presentation to a duly authorized Federal, State, or local enforcement official. The exemption will be rescinded if: (1) The person fails to comply with the terms and conditions of the exemption; (2) the exemption has resulted in a lower level of safety than was maintained before it was granted; or (3) continuation of the exemption would not be consistent with the goals and objectives of 49 U.S.C. 31136(e) and 31315.
During the period the exemption is in effect, no State shall enforce any law or regulation that conflicts with this exemption with respect to a person operating under the exemption.
Based upon its evaluation of the 191 exemption applications, FMCSA renews the exemptions of the aforementioned drivers from the rule prohibiting drivers with ITDM from driving CMVs in interstate commerce. In accordance with 49 U.S.C. 31136(e) and 31315, each exemption will be valid for two years unless revoked earlier by FMCSA.
Internal Revenue Service (IRS), Treasury.
Notice and request for comments.
The Internal Revenue Service, as part of its continuing effort to reduce paperwork and respondent burden, invites the general public and other Federal agencies to take this opportunity to comment on proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995.
Written comments should be received on or before June 18, 2018 to be assured of consideration.
Direct all written comments to Laurie Brimmer, Internal Revenue Service, Room 6526, 1111 Constitution Avenue NW, Washington, DC 20224.
To obtain additional information, or copies of the information collection and instructions, or copies of any comments received, contact LaNita Van Dyke, at (202) 317-6009, at Internal Revenue Service, Room 6526, 1111 Constitution Avenue NW, Washington, DC 20224, or through the internet, at
The Internal Revenue Service, as part of their continuing effort to reduce paperwork and respondent burden, invite the general public and other Federal agencies to take this opportunity to comment on the proposed or continuing information collections listed below in this notice, as required by the Paperwork Reduction Act of 1995, (44 U.S.C. 3501
The IRS is seeking comments concerning the following form, and reporting and record-keeping requirements:
The following paragraph applies to the collection of information covered by this notice:
An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless the collection of information displays a valid OMB control number. Books or records relating to a collection of information must be retained as long as their contents may become material in the administration of any internal revenue law. Generally, tax returns and tax return information are confidential, as required by 26 U.S.C. 6103.
Veterans Health Administration, Department of Veterans Affairs.
Notice.
In compliance with the Paperwork Reduction Act (PRA) of 1995, this notice announces that the Veterans Health Administration, Department of Veterans Affairs, will submit the collection of information abstracted below to the Office of Management and Budget (OMB) for review and comment. The PRA submission describes the nature of the information collection and its expected cost and burden and it includes the actual data collection instrument.
Comments must be submitted on or before May 17, 2018.
Submit written comments on the collection of information through
Cynthia D. Harvey-Pryor, Office of Quality, Privacy and Risk (OQPR), Department of Veterans Affairs, 810 Vermont Avenue NW, Washington, DC 20420, (202) 461-5870 or 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. The
Recruitment Screening Module—517 hours.
Spirometry Screening Module—1,033 hours.
Military Overview Module—517 hours.
OEF/OIF/OND Location Module—1,550 hours.
Non-OEF/OIF/OND Location Module—1,550 hours.
OEF/OIF/OND Exposure Module—1,033 hours.
Non-OEF/OIF/OND Exposure Module—1,033 hours.
Civilian Occupation and Hobby Exposure Module—517 hours.
Health, Smoking, and Demographics Module—1,550 hours.
Medication and Dietary Supplement Module—1,033 hours.
Participant Status Check-In Module—517 hours.
Spirometry—3,617 hours.
Medical History Module—517 hours.
Functional Health Module—413 hours.
Health Symptoms Module—310 hours.
Current Mood Module—517 hours.
Participant Feedback Module—310 hours.
Post-Visit Feedback Module—52 hours.
Recruitment Screening Module—5 minutes.
Spirometry Screening Module—10 minutes.
Military Overview Module—5 minutes.
OEF/OIF/OND Location Module—15 minutes.
Non-OEF/OIF/OND Location Module—15 minutes.
OEF/OIF/OND Exposure Module—10 minutes.
Non-OEF/OIF/OND Exposure Module—10 minutes.
Civilian Occupation and Hobby Exposure Module—5 minutes.
Health, Smoking, and Demographics Module—15 minutes.
Medication and Dietary Supplement Module—10 minutes.
Participant Status Check-In Module—5 minutes.
Spirometry—35 minutes.
Medical History Module—5 minutes.
Functional Health Module—4 minutes.
Health Symptoms Module—3 minutes.
Current Mood Module—5 minutes.
Participant Feedback Module—3 minutes.
Post-Visit Feedback Module—10 minutes.
Recruitment Screening Module—6200.
Spirometry Screening Module—6200.
Military Overview Module—6200.
OEF/OIF/OND Location Module—6200.
Non-OEF/OIF/OND Location Module—6200.
OEF/OIF/OND Exposure Module- 6200.
Non-OEF/OIF/OND Exposure Module—6200.
Civilian Occupation and Hobby Exposure Module—6200.
Health, Smoking, and Demographics Module—6200.
Medication and Dietary Supplement Module—6200.
Participant Status Check-In Module- 6200.
Spirometry—6200.
Medical History Module—6200.
Functional Health Module—6200.
Health Symptoms Module—6200.
Current Mood Module—6200.
Participant Feedback Module—6200.
Post-Visit Feedback Module—310.
By direction of the Secretary.
Veterans Benefits Administration, Department of Veterans Affairs.
Notice.
The Veterans Benefits Administration (VBA), Department of Veterans Affairs (VA), is announcing an opportunity for public comment on the proposed collection of certain information by the agency. Under the Paperwork Reduction Act (PRA) of 1995, Federal agencies are required to publish notice in the
Written comments and recommendations on the proposed collection of information should be received on or before June 18, 2018.
Submit written comments on the collection of information through Federal Docket Management System (FDMS) at
Cynthia D. Harvey-Pryor at (202) 461-5870.
Under the PRA of 1995, Federal agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. This request for comment is being made pursuant to the PRA.
With respect to the following collection of information, VBA invites comments on: (1) Whether the proposed collection of information is necessary for the proper performance of VBA's functions, including whether the information will have practical utility; (2) the accuracy of VBA's estimate of the burden of the proposed collection of information; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or the use of other forms of information technology.
By direction of the Secretary.
Veterans Health Administration, Department of Veterans Affairs.
Notice.
Veterans Health Administration, Department of Veterans Affairs (VA), is announcing an opportunity for public comment on the proposed collection of certain information by the agency. Under the Paperwork Reduction Act (PRA) of 1995, Federal agencies are required to publish notice in the
Written comments and recommendations on the proposed collection of information should be received on or before June 18, 2018.
Submit written comments on the collection of information through Federal Docket Management System (FDMS) at
Brian McCarthy at (202) 615-9241.
Under the PRA of 1995, Federal agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. This request for comment is being made pursuant to Section 3506 of the PRA.
With respect to the following collection of information, VHA invites comments on: (1) Whether the proposed collection of information is necessary for the proper performance of VHA's functions, including whether the information will have practical utility; (2) the accuracy of VHA's estimate of the burden of the proposed collection of information; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or the use of other forms of information technology.
Request for VA Billing—385 hours.
CHAMPVA Request for Billing—303 hours.
Request for VA Billing—7 minutes.
CHAMPVA Request for Billing—7 minutes.
Request for VA Billing—3,300.
CHAMPVA Request for Billing—2,600.
By direction of the Secretary.
Department of Veterans Affairs.
Notice of availability and request for comment.
The Department of Veterans Affairs (VA) is reviewing its capital asset inventory and identifying vacant and underutilized buildings, structures and land. VA may consider sales, public benefit conveyances, demolition and deconstruction to reduce its unneeded real property. Additionally, VA may consider leases and exchanges to non-Federal entities for potential reuse of vacant and underutilized buildings and structures. This announcement pertains to an alternative process VA may utilize to comply with the requirements of the National Historic Preservation Act (NHPA).
The Advisory Council on Historic Preservation (ACHP) is a Federal agency tasked with review of other Federal agencies' compliance with NHPA and the implementing regulations. VA intends to request ACHP to consider a Program Comment for the entire program of reduction of vacant and underutilized properties. ACHP may agree or decline to consider VA's Program Comment request. If ACHP does issue a Program Comment in lieu of case-by-case review, this alternative will conserve VA's time, budget and staff resources. It will enable VA to transfer real property rights of the vacant and underutilized properties more quickly while still giving consideration to historic properties as required by NHPA.
This Notice of Availability announces and invites public involvement in the process of development of the Program Comment for consideration of historic properties that are vacant and underutilized buildings, structures and land that may be historic properties. Historic properties are those listed on the National Register of Historic Places or eligible for such listing.
Comments should be submitted within 30 days from when this announcement is published in the
Written comments may be submitted by email through
Douglas Pulak, Federal Preservation Officer (003C2), Department of Veterans Affairs, 810 Vermont Avenue NW, Washington, DC 20420.
Section 106 of the National Historic Preservation Act (54 U.S.C. 306108) requires Federal agencies to take into account the effects of their undertakings on historic properties and provide ACHP a reasonable opportunity to comment with regard to such undertakings. ACHP regulations, codified at 36 CFR part 800, set forth the process by which Federal agencies comply with NHPA requirements.
Under Section 800.14(e), Federal agencies may request ACHP to provide a Program Comment on a particular program and category of undertakings in lieu of conducting individual reviews of each individual undertaking as set forth in 36 CFR Sections 800.4 through 800.6. A Federal agency can meet its Section 106 responsibilities for a category of undertakings by taking into account ACHP's Program Comment and by following the steps set forth in those comments.
To initiate this process, VA intends to request ACHP to consider a Program Comment for its program to reduce its real property inventory of vacant and underutilized properties at VA Medical Centers and National Cemeteries nationwide. VA intends the program comment to ACHP will encompass a variety of real estate actions such as leases (including both Enhanced-Use Leases under VA's authority at 38 U.S.C. 8161-8169, and NHPA Section 111 leases authorized under 16 U.S.C. 470h-3), exchanges, sales, transfers, deconstruction and demolition of buildings and structures. ACHP will decide whether to issue a Program Comment to VA or decline. If ACHP decides to issue the Program Comment, they will publish a draft in the
VA initiated the identification of historic properties in its capital asset inventory several decades ago. VA identified, in consultation with State Historic Preservation Offices, approximately 65 percent of the medical centers as having some buildings and structures, or districts eligible or listed on the National Register of Historic Places. All of the National Veterans Cemeteries are listed on the National Register. The development of VA and its historic role in the care and treatment of veterans over time is significant in the history of the United States.
The analysis of buildings and structures that are no longer needed or cannot be adapted for current use will aid VA in reducing its real property inventory. Many buildings and structures are not useful for VA's mission. In general, they tend to be warehouses, garages, sheds, animal research structures, and other utilitarian buildings. Most of these types of buildings and structures are not eligible or contributing to a historic district. VA intends to propose deconstruction or demolition of these properties without further consideration under the Program Comment.
For buildings, structures and land that may serve other non-Federal entities purpose, VA may be able to out lease them. The leases would contain specific requirements for treatment of the character defining features of the historic property if the lessee is pursuing tax credits for rehabilitation of the historic property. For all other leases of historic properties, the reuse proposal would be evaluated with the lessee for potential retention of any character defining features such as windows, entry spaces, staircases and historic landscaping. If it is not possible to retain significant historic features of a building or structure, they will be documented prior to removal or alteration.
The Secretary of Veterans Affairs, or designee, approved this document and authorized the undersigned to sign and submit the document to the Office of the Federal Register for publication electronically as an official document of the Department of Veterans Affairs. Jacquelyn Hayes-Byrd, Deputy Chief of Staff, Department of Veterans Affairs, approved this document on April 11, 2018, for publication.
Veterans Benefits Administration, Department of Veterans Affairs.
Notice.
The Veterans Benefits Administration (VBA), Department of Veterans Affairs (VA), is announcing an opportunity for public comment on the proposed collection of certain information by the agency. Under the Paperwork Reduction Act (PRA) of 1995, Federal agencies are required to publish notice in the
The VA Form 22-1995 is used to determine the applicant's continued eligibility to educational assistance administered by VA after a change in training or the place where training is pursued.
Written comments and recommendations on the proposed collection of information should be received on or before June 18, 2018.
Submit written comments on the collection of information through Federal Docket Management System (FDMS) at
Nancy J. Kessinger at (202) 632-8924 or FAX (202) 632-8925.
Under the PRA of 1995, Federal agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. This request for comment is being made pursuant to of the PRA.
With respect to the following collection of information, VBA invites comments on: (1) Whether the proposed collection of information is necessary for the proper performance of VBA's functions, including whether the information will have practical utility; (2) the accuracy of VBA's estimate of the burden of the proposed collection of information; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or the use of other forms of information technology.
By direction of the Secretary.
Veterans Health Administration, Department of Veterans Affairs
Notice.
Veterans Health Administration, Department of Veterans
Written comments and recommendations on the proposed collection of information should be received on or before June 18, 2018.
Submit written comments on the collection of information through Federal Docket Management System (FDMS) at
Brian McCarthy at (202) 461-6345.
Under the PRA of 1995, Federal agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. This request for comment is being made pursuant to Section 3506 of the PRA.
With respect to the following collection of information, VHA invites comments on: (1) Whether the proposed collection of information is necessary for the proper performance of VHA's functions, including whether the information will have practical utility; (2) the accuracy of VHA's estimate of the burden of the proposed collection of information; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or the use of other forms of information technology.
By direction of the Secretary.
Veterans Health Administration, Department of Veterans Affairs.
Notice.
The Veterans Health Administration (VHA) is announcing an opportunity for public comment on the proposed collection of certain information by the agency. Under the Paperwork Reduction Act (PRA) of 1995, Federal agencies are required to publish notice in the
Written comments and recommendations on the proposed collection of information should be received on or before June 18, 2018.
Submit written comments on the collection of information through the Federal Docket Management System (FDMS) at
Brian McCarthy at (202) 461-6345.
Under the PRA of 1995, Federal agencies must obtain approval from OMB for each collection of information they conduct or sponsor. This request for comment is being made pursuant to Section 3506(c)(2)(A) of the PRA.
With respect to the following collection of information, VHA invites comments on: (1) Whether the proposed collection of information is necessary for the proper performance of VHA's functions, including whether the information will have practical utility; (2) the accuracy of VHA's estimate of the burden of the proposed collection of information; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or the use of other forms of information technology.
1. Academic Verification, VA Form 10-0491.
2. Addendum to Application, VA Form 10-0491a.
3. Annual VA Employment Deferment Verification, VA Form 10-0491c
4. Education Program Completion Notice Service Obligation Placement, VA Form 10-0491d
5. Evaluation Recommendation Form, VA Form 10-0491e
6. HPSP Agreement, VA Form 10-0491f
7. HPSP/OMPSP Application, VA Form 10-0491g
8. Notice of Approaching Graduation, VA Form 10-0491h
9. Notice of Change and/or Annual Academic Status Report, VA Form 10-0491i
10. Request for Deferment for Advanced Education, VA Form 10-0491j
11. VA Scholarship Offer Response, VA Form 10-0491k
12. VIOMPSP Agreement, VA Form 10-0491l
13. Mobility Agreement, VA Form 10-0491m
The information required determines the eligibility or suitability of an applicant desiring to receive an award under the provisions of 38 U.S.C. 7601 through 7619, and 38 U.S.C. 7501 through 7505. The information is needed to apply for the VA Health Professional Scholarship Program or Visual Impairment and Orientation and Mobility Professional Scholarship Program. The VA Health Professional Scholarship Program awards scholarships to students receiving education or training in a direct or indirect healthcare services discipline to assist in providing an adequate supply of such personnel for VA and for the United States. The Visual Impairment and Orientation and Mobility Professional Scholarship Program awards scholarships to students pursuing a program of study leading to a degree in visual impairment or orientation and mobility in order to increase the supply of qualified blind rehabilitation specialists for VA and the Nation.
By direction of the Secretary.
Centers for Medicare & Medicaid Services (CMS), HHS.
Final rule.
This final rule sets forth payment parameters and provisions related to the risk adjustment and risk adjustment data validation programs; cost-sharing parameters; and user fees for Federally-facilitated Exchanges and State Exchanges on the Federal platform. It finalizes changes that provide additional flexibility to States to apply the definition of essential health benefits (EHB) to their markets, enhance the role of States regarding the certification of qualified health plans (QHPs); and provide States with additional flexibility in the operation and establishment of Exchanges, including the Small Business Health Options Program (SHOP) Exchanges. It includes changes to standards related to Exchanges; the required functions of the SHOPs; actuarial value for stand-alone dental plans; the rate review program; the medical loss ratio program; eligibility and enrollment; exemptions; and other related topics.
Lindsey Murtagh, (301) 492-4106, Rachel Arguello, (301) 492-4263, Alper Ozinal, (301) 492-4178, or Abigail Walker, (410) 786-1725, for general information.
Krutika Amin, (301) 492-5153, for matters related to risk adjustment, and user fees for Federally-facilitated Exchanges and State-Exchanges on the Federal platform.
Adrianne Patterson, (410) 786-0686, or Abigail Walker, (410) 786-1725, for matters related to sequestration.
Melissa Jaffe, (301) 492-4129, for matters related to risk adjustment data validation, cost-sharing reductions, and the premium adjustment percentage.
Lisa Cuozzo, (410) 786-1746, for matters related to rate review.
Jenny Chen, (301) 492-5156, for matters related to establishing a State Exchange, and State Exchanges on the Federal platform.
Emily Ames, (301) 492-4246, for matters related to Navigators and non-Navigator assistance personnel.
Elissa Dines, (301) 492-4388, for matters related to employer-sponsored coverage verification.
Kendra May, (301) 492-4477, for matters related to the requirement to file an income tax return and reconcile APTC and terminations.
Carolyn Kraemer, (301) 492-4197, for matters related to special enrollment periods under part 155.
Amanda Brander, (202) 690-7892, for matters related to exemptions from the individual shared responsibility payment.
Terence Kane, (301) 492-4449, for matters related to income inconsistencies.
Jacob Schnur, (410) 786-7703, for matters related to direct enrollment.
Laura Eldon, (301) 492-4372, for matters related to the Federally-facilitated SHOP.
Shilpa Gogna, (301) 492-4257, for matters related to SHOP in State Exchanges.
Leigha Basini, (301) 492-4380, Rebecca Zimmermann, (301) 492-4396, or Allison Yadsko, (410) 786-1740, for matters related to standardized options, essential health benefits, stand-alone dental plans and other standards for QHP issuers.
Cam Moultrie Clemmons, (206) 615-2338, for matters related to minimum essential coverage.
Christina Whitefield, (301) 492-4172, for matters related to the medical loss ratio program.
American Health Benefit Exchanges, or “Exchanges” (also called “Marketplaces”) are entities established under the Patient Protection and Affordable Care Act (PPACA) through which qualified individuals and qualified employers can purchase health insurance coverage. Many individuals who enroll in qualified health plans (QHPs) through individual market Exchanges are eligible to receive a premium tax credit (PTC) to reduce their costs for health insurance premiums, and receive reductions in required cost-sharing payments to reduce out-of-pocket expenses for health care services. The PPACA also established the risk adjustment program, which is intended to mitigate the potential impact of adverse selection and stabilize the price of health insurance in the individual and small group markets, both on and off Exchanges.
Over time, issuer exits and increasing insurance premiums have threatened the stability of the individual and small group Exchanges in many geographic areas. In previous rulemaking, we established provisions and parameters to implement many PPACA provisions and programs. In this final rule, we amend these provisions and parameters, with a focus on enhancing the role of States in these programs and providing States with additional flexibilities, reducing unnecessary regulatory burden
On January 20, 2017, the President issued an Executive Order which stated that, to the maximum extent permitted by law, the Secretary of HHS and heads of all other executive departments and agencies with authorities and responsibilities under the PPACA should exercise all authority and discretion available to them to waive, defer, grant exemptions from, or delay the implementation of any provision or requirement of the PPACA that would impose a fiscal burden on any State or a cost, fee, tax, penalty, or regulatory burden on individuals, families, health care providers, health insurers, patients, recipients of health care services, purchasers of health insurance, or makers of medical devices, products, or medications. In this rule, within the limitations of the current statute, we are finalizing policies to reduce fiscal and regulatory burdens across different program areas, and to support innovative health insurance models.
We are finalizing several changes that would significantly expand the role of States in the administration of the PPACA. We received comments on additional ways to support State Exchanges (SBEs) in adopting innovative approaches to operating and sustaining their Exchanges, and to make the State Exchange on the Federal platform (SBE-FP) model a more appealing and viable model for States. We finalize policies under which States assume a larger role in reviewing the QHP certification standards of network adequacy and essential community providers for the Federally-facilitated Exchanges (FFEs). This will confirm States' traditional role in overseeing their health insurance markets, and reduce the issuer burden associated with having to comply with duplicative State and Federal reviews.
This rule also finalizes several policies that will provide States with greater flexibility. For example, this rule provides States with additional flexibility in applying the definition of EHBs to their markets starting with the 2020 plan year. In addition to granting States more flexibility regulating their markets, we believe this change would permit States to modify EHBs to increase affordability of health insurance in the individual and small group markets. This rule also provides States with significantly more flexibility in how they operate a Small Business Health Options Program (SHOP), permitting them to operate these Exchanges more efficiently, and therefore benefitting States, issuers, employers, and employees. These changes would allow for a more efficient SHOP, such that employers and employees could enroll in SHOP coverage by working with a QHP issuer or SHOP-registered agent or broker. Additionally, the finalized policies provide States more flexibility regarding risk adjustment transfers in their markets. We also make it easier for States to apply for and be granted an adjustment to the individual market medical loss ratio (MLR) standard in their State. We believe this change provides States with an additional tool to help stabilize, innovate and provide relief in their individual markets. Additionally, we make other changes to the MLR program to reduce the burden on issuers.
Risk adjustment continues to be a core program for stabilizing the individual and small group markets both on and off Exchanges, and we are finalizing recalibrated parameters for the HHS risk adjustment methodology. We are also finalizing several changes related to the risk adjustment data validation program that are intended to ensure the integrity of the results of risk adjustment, while alleviating issuer burden.
As we do every year in the HHS notice of benefit and payment parameters final rule, we are finalizing updated parameters applicable in the individual and small group markets. We are finalizing the user fee rate for issuers participating on FFEs and SBE-FPs for 2019 to be 3.5 and 3.0 percent of premiums, respectively. We are finalizing the premium adjustment percentage for 2019, which is used to set the rate of increase for several parameters detailed in the PPACA, including the maximum annual limitation on cost sharing for 2019, the required contribution percentage used to determine eligibility for certain exemptions under section 5000A of the Internal Revenue Code of 1986 (the Code), and the assessable payment amounts under section 4980H(a) and (b) of the Code. We are finalizing updates to the maximum annual limitations on cost sharing for the 2019 benefit year for cost-sharing reductions plan variations.
We are finalizing a number of changes related to rate review that are intended to reduce regulatory burden on States and issuers in regard to the rate filing process. Specifically, we are exempting student health insurance coverage from Federal rate review requirements, beginning with coverage effective on or after July 1, 2018. We are also modifying the 10 percent threshold for reasonableness review to a 15 percent default threshold.
Recognizing that Exchanges, including the FFEs, face resource constraints, we are changing the requirements regarding Navigators, and the requirements regarding non-Navigator assistance personnel subject to § 155.215, to enable Exchanges to more easily operate these programs with limited resources. Similarly, we are allowing an agent, broker or issuer participating in direct enrollment to have its selected third-party entity conduct operational readiness reviews, rather than requiring that those reviews be conducted by entities approved by HHS.
We also finalize relatively minor adjustments to our programs and rules as we do each year in the HHS notice of benefit and payment parameters. We are finalizing a number of incremental amendments to our policies around coverage, eligibility, enrollment, and affordability exemptions.
We continue to be very interested in exploring ways to improve Exchange program integrity. In the proposed rule, we sought comment on a number of program integrity items, including whether we should consider shortening the length of time the Exchanges are authorized to obtain enrollee tax information, as well as ways to prompt more timely consumer reporting of changes in circumstances during the benefit year that may impact an individual's eligibility for coverage and financial assistance. In addition, we requested comment on any additional program integrity improvements that were not outlined in the proposed rule, but could be beneficial in a future rulemaking.
Finally, as noted in the proposed rule, we intend to consider proposals in future rulemaking that would help reduce drug costs and promote drug price transparency. We also intend to provide guidance on other aspects of Exchange eligibility in the near future. In particular, we intend to reconsider the appropriate thresholds for changes in income that will trigger a data matching inconsistency, processes for denying eligibility for advance subsidies for individuals who fail to reconcile advance payments of the premium tax credit (APTC) on their Federal income tax return, processes for matching enrollment data with the Medicare and Medicaid programs in order to help consumers avoid duplicate enrollments, and the appropriate manner of recalculating APTC following a midyear change in eligibility, and sought comments on each of these issues as we prepare rulemaking on these topics.
Instituting strong program safeguards to ensure that only individuals who are eligible are enrolled in Exchange coverage, and that they are only
The Patient Protection and Affordable Care Act (Pub. L. 111-148) was enacted on March 23, 2010. The Health Care and Education Reconciliation Act of 2010 (Pub. L. 111-152), which amended and revised several provisions of the Patient Protection and Affordable Care Act, was enacted on March 30, 2010. In this final rule, we refer to the two statutes collectively as the “Patient Protection and Affordable Care Act” or “PPACA.”
Subtitles A and C of title I of the PPACA reorganized, amended, and added to the provisions of part A of title XXVII of the Public Health Service Act (PHS Act) relating to group health plans and health insurance issuers in the group and individual markets.
Section 2701 of the PHS Act, as added by the PPACA, restricts the variation in premium rates charged by a health insurance issuer for non-grandfathered health insurance coverage in the individual or small group market to certain specified factors. These factors are family size, rating area, age and tobacco use.
Section 2701 of the PHS Act operates in coordination with section 1312(c) of the PPACA. Section 1312(c) of the PPACA generally requires a health insurance issuer to consider all enrollees in all health plans (except for grandfathered health plans) offered by such issuer to be members of a single risk pool for each of its individual and small group markets. States have the option to merge the individual market and small group market risk pools under section 1312(c)(3) of the PPACA.
Section 2702 of the PHS Act, as added by the PPACA, requires health insurance issuers that offer health insurance coverage in the group or individual market in a State to offer coverage to and accept every employer and individual in the State that applies for such coverage unless an exception applies.
Section 2703 of the PHS Act, as added by the PPACA, and sections 2712 and 2741 of the PHS Act, as added by the Health Insurance Portability and Accountability Act of 1996 (Pub. L. 104-191) (HIPAA) prior to the enactment of the PPACA, require health insurance issuers that offer health insurance coverage in the group or individual market to renew or continue in force such coverage at the option of the plan sponsor or individual unless an exception applies.
Section 2718 of the PHS Act, as added by the PPACA, generally requires health insurance issuers to submit an annual MLR report to HHS, and provide rebates to enrollees if the issuers do not achieve specified MLR thresholds.
Section 2794 of the PHS Act, as added by the PPACA, directs the Secretary of HHS (the Secretary), in conjunction with the States, to establish a process for the annual review of “unreasonable increases in premiums for health insurance coverage.”
Section 1252 of the PPACA provides that any standard or requirement adopted by a State under title I of the PPACA, or any amendment made by title I of the PPACA, is to be applied uniformly to all health plans in each insurance market to which the standard and requirement apply.
Section 1302 of the PPACA provides for the establishment of an EHB package that includes coverage of EHB (as defined by the Secretary), cost-sharing limits, and actuarial value requirements. The law directs that EHBs be equal in scope to the benefits provided under a typical employer plan, and that they cover at least the following 10 general categories: Ambulatory patient services; emergency services; hospitalization; maternity and newborn care; mental health and substance use disorder services, including behavioral health treatment; prescription drugs; rehabilitative and habilitative services and devices; laboratory services; preventive and wellness services and chronic disease management; and pediatric services, including oral and vision care.
Section 1301(a)(1)(B) of the PPACA directs all issuers of QHPs to cover the EHB package described in section 1302(a) of the PPACA, including coverage of the services described in section 1302(b) of the PPACA, to adhere to the cost-sharing limits described in section 1302(c) of the PPACA and to meet the AV levels established in section 1302(d) of the PPACA. Section 2707(a) of the PHS Act, which is effective for plan or policy years beginning on or after January 1, 2014, extends the coverage of the EHB package to non-grandfathered individual and small group health insurance coverage, irrespective of whether such coverage is offered through an Exchange. In addition, section 2707(b) of the PHS Act directs non-grandfathered group health plans to ensure that cost sharing under the plan does not exceed the limitations described in sections 1302(c)(1) of the PPACA.
Section 1302(d) of the PPACA describes the various levels of coverage based on actuarial value (AV). Consistent with section 1302(d)(2)(A) of the PPACA, AV is calculated based on the provision of EHB to a standard population. Section 1302(d)(3) of the PPACA directs the Secretary to develop guidelines that allow for
Section 1311(b)(1)(B) of the PPACA directs that the Small Business Health Options Program assist qualified small employers in facilitating the enrollment of their employees in QHPs offered in the small group market. Sections 1312(f)(1) and (2) of the PPACA define qualified individuals and qualified employers. Under section 1312(f)(2)(B) of the PPACA, beginning in 2017, States have the option to allow issuers to offer QHPs in the large group market through an Exchange.
Section 1311(c)(1)(B) of the PPACA requires the Secretary to establish minimum criteria for provider network adequacy that a health plan must meet to be certified as a QHP.
Section 1311(c)(5) of the PPACA requires the Secretary to continue to operate, maintain, and update the internet portal developed under section 1103 of the PPACA to provide information to consumers and small businesses on affordable health insurance coverage options.
Sections 1311(d)(4)(K) and 1311(i) of the PPACA direct all Exchanges to establish a Navigator program.
Section 1311(c)(6)(C) of the PPACA establishes special enrollment periods and section 1311(c)(6)(D) of the PPACA establishes the monthly enrollment period for Indians, as defined by section 4 of the Indian Health Care Improvement Act.
Section 1312(e) of the PPACA directs the Secretary to establish procedures under which a State may permit agents and brokers to enroll qualified individuals and qualified employers in QHPs through an Exchange and to assist individuals in applying for financial assistance for QHPs sold through an Exchange.
Section 1321(a) of the PPACA provides broad authority for the Secretary to establish standards and regulations to implement the statutory requirements related to Exchanges, QHPs and other components of title I of the PPACA. Section 1321(a)(1) of the PPACA directs the Secretary to issue regulations that set standards for meeting the requirements of title I of the PPACA with respect to, among other things, the establishment and operation of Exchanges.
Sections 1313 and 1321 of the PPACA provide the Secretary with the authority to oversee the financial integrity of State Exchanges, their compliance with HHS standards, and the efficient and non-discriminatory administration of State Exchange activities. Section 1321 of the PPACA provides for State flexibility in the operation and enforcement of Exchanges and related requirements.
When operating an FFE under section 1321(c)(1) of the PPACA, HHS has the authority under sections 1321(c)(1) and 1311(d)(5)(A) of the PPACA to collect and spend user fees. In addition, 31 U.S.C. 9701 permits a Federal agency to establish a charge for a service provided by the agency. Office of Management and Budget (OMB) Circular A-25 Revised establishes Federal policy regarding user fees and specifies that a user charge will be assessed against each identifiable recipient for special benefits derived from Federal activities beyond those received by the general public.
Section 1321(c)(2) of the PPACA authorizes the Secretary to enforce the Exchange standards using civil money penalties (CMPs) on the same basis as detailed in section 2723(b) of the PHS Act. Section 2723(b) of the PHS Act authorizes the Secretary to impose CMPs as a means of enforcing the individual and group market reforms contained in Part A of title XXVII of the PHS Act when a State fails to substantially enforce these provisions.
Section 1321(d) of the PPACA provides that nothing in title I of the PPACA should be construed to preempt any State law that does not prevent the application of title I of the PPACA. Section 1311(k) of the PPACA specifies that Exchanges may not establish rules that conflict with or prevent the application of regulations issued by the Secretary.
Section 1343 of the PPACA establishes a permanent risk adjustment program to provide payments to health insurance issuers that attract higher-risk populations, such as those with chronic conditions, funded by payments from those that attract lower-risk populations; thereby, reducing incentives for issuers to avoid higher-risk enrollees.
Section 1402 of the PPACA provides for, among other things, reductions in cost sharing for EHB for qualified low- and moderate-income enrollees in silver level health plans offered through the individual market Exchanges. This section also provides for reductions in cost sharing for Indians enrolled in QHPs at any metal level.
Section 5000A of the Code, as added by section 1501(b) of the PPACA, requires all applicable individuals to maintain minimum essential coverage (MEC) for each month or make an individual shared responsibility payment. Section 5000A(f) of the Code defines MEC as any of the following: (1) Coverage under a specified government sponsored program; (2) coverage under an eligible employer-sponsored plan; (3) coverage under a health plan offered in the individual market within a State; and (4) coverage under a grandfathered health plan. In addition, the HEALTHY KIDS Act amended section 5000A(f)(1)(A)(iii) of the Code to include in the definition of MEC CHIP look-alike plans, which are CHIP buy-in programs that provide benefits that are at least identical to the benefits provided by the title XXI CHIP program.
The Protecting Affordable Coverage for Employees Act (Pub. L. 114-60) amended section 1304(b) of the PPACA and section 2791(e) of the PHS Act to amend the definition of small employer in these statutes to mean, in connection with a group health plan with respect to a calendar year and a plan year, an employer who employed an average of at least 1 but not more than 50 employees on business days during the preceding calendar year and who employs at least 1 employee on the first day of the plan year. It also amended these statutes to make conforming changes to the definition of large employer, and to provide that a State may treat as a small employer, with respect to a calendar year and a plan year, an employer who employed an average of at least 1 but not more than 100 employees on business days during the preceding calendar year and who employs at least 1 employee on the first day of the plan year.
In the July 15, 2011
In the December 2, 2013
In the November 26, 2014
In the December 2, 2015
In the September 6, 2016
In the June 19, 2013
We published a request for comment relating to Exchanges in the August 3, 2010
We established additional standards for SHOP in the 2014 Payment Notice and in the Amendments to the HHS Notice of Benefit and Payment Parameters for 2014 interim final rule, published in the March 11, 2013
In a final rule published in the July 17, 2013
In an interim final rule, published in the May 11, 2016
On December 16, 2011, HHS released a bulletin
In the February 1, 2013
In the November 26, 2014
A proposed rule relating to the 2014 health insurance market rules was published in the November 26, 2012
A proposed rule relating to Exchanges and Insurance Market Standards for 2015 and Beyond was published in the March 21, 2014
A proposed rule to establish the rate review program was published in the December 23, 2010
We published a request for comment on section 2718 of the PHS Act in the April 14, 2010
HHS has consulted with stakeholders on policies related to the operation of Exchanges, including the SHOP, and the premium stabilization programs. We have held a number of listening sessions with consumers, providers, employers, health plans, and the actuarial community to gather public input. We have solicited input from State representatives on numerous topics, particularly EHB, QHP certification and Exchange establishment. We consulted with stakeholders through regular meetings with the National Association of Insurance Commissioners (NAIC), regular contact with States through the Exchange Establishment grant and Exchange Blueprint approval processes, and meetings with Tribal leaders and representatives, health insurance issuers, trade groups, consumer advocates, employers, and other interested parties. We considered all public input we received as we developed the policies in this final rule.
HHS also received several thousand unique comments in response to a request for information, entitled “Reducing Regulatory Burdens Imposed by the Patient Protection and Affordable Care Act and Improving Healthcare Choices to Empower Patients”, published in the June 12, 2017
The regulations outlined in this final rule will be codified in 45 CFR parts 147, 153, 154, 155, 156, 157, and 158.
The final regulations in part 147 amend the rules regarding fair health insurance premiums and guaranteed availability to reflect final changes related to the SHOPs and special enrollment periods.
In connection with part 153, we are recalibrating the risk adjustment models consistent with the methodology finalized for the 2018 benefit year with slight modifications to the drug classes included in the 2019 benefit year adult models and the incorporation of blended MarketScan® and the most recent enrollee-level External Data Gathering Environment (EDGE) data. This final rule addresses the high-cost risk pooling adjustment, where we are finalizing the same parameters that applied to the 2018 benefit year for the 2019 benefit year risk adjustment. The finalized provisions related to part 153 include the risk adjustment user fee and modifications to risk adjustment data validation. We also finalize a policy to provide States flexibility to request reductions in risk adjustment transfers in the small group market starting for the 2020 benefit year and beyond.
The final regulations in part 154 finalize certain modifications to reduce regulatory burden and enhance State flexibility for the rate review program. We are finalizing an exemption for student health insurance coverage from Federal rate review requirements. We are finalizing a proposal to raise the default threshold for review of reasonableness in the rate review process from 10 percent to 15 percent. We also are finalizing a proposal to allow States with Effective Rate Review Programs to set later submission deadlines for rate filings from issuers that offer non-QHPs only. In addition, we are finalizing the change to the notification period for States with Effective Rate Review Programs to provide advance notice to HHS prior to posting rate increases (from 30 days to 5 business days).
The final regulations in part 155 include modifications to the functions of an Exchange, and a new approach to operational readiness reviews for direct enrollment partners which will allow agents, brokers, and issuers to select their own third-party entities for conducting those reviews. We are finalizing modifications to the rules around verification of eligibility. We are also finalizing increased flexibility in the Navigator program by removing the requirement that each Exchange must have at least two Navigator entities, one of which must be a community and consumer focused non-profit, and by removing the standard requiring physical presence of the Navigator entity in the Exchange service area. We are modifying the parameters around certain special enrollment periods. We are modifying the effective date options for enrollee-initiated terminations, at the option of the Exchange, and amending the affordability exemption so that it may be based on the lowest cost Exchange plan if there is no bronze level plan sold through the Exchange in that rating area.
The final regulations in part 156 include changes to EHB and the QHP certification process. The final regulations in part 156 set forth parameters related to cost sharing, including the premium adjustment percentage, the maximum annual limitation on cost sharing, and the reductions in the maximum annual limitation for cost-sharing plan variations for 2019. The regulations at part 156 also include finalized FFE and SBE-FP user fee rates for the 2019 benefit year for all issuers participating on the FFEs or SBE-FPs. The regulations at part 156 also include finalized policies related to actuarial value for stand-alone dental plans (SADPs).
The final amendments to the regulations in parts 155, 156, and 157 include finalized proposals that would provide SHOPs with additional operational flexibility, and would modify the requirements for issuers, employers, and employees interacting with SHOPs.
The final amendments to the regulations in part 158 include revisions related to reporting quality improvement activity expenses as part
In the November 2, 2017
In this final rule, we provide a summary of each proposed provision, a summary of those public comments received that directly related to the proposals, our responses to them, and a description of the provisions we are finalizing.
As discussed elsewhere in this final rule, we are finalizing substantial changes to the requirements applicable to SHOPs to provide those programs with the flexibility to operate in a leaner fashion, a flexibility that we intend to utilize in the Federally-facilitated Small Business Health Options Program (FF-SHOP). As part of these changes and, as discussed in the preamble to §§ 156.285 and 156.286, we proposed that, effective on the effective date of this rule, the requirement in § 156.285(a)(4)(ii) regarding premium rating standards in the FF-SHOPs would not apply for plan years beginning on or after January 1, 2018. Therefore, we proposed to delete from § 147.102(c)(3)(iii)(D) a reference to § 156.285(a)(4), and to replace the reference to FF-SHOPs with a reference to SHOPs generally, to reflect that, under the proposed approach for SHOPs, some SHOPs may want to prohibit issuers from offering average enrollee premiums.
We did not receive comments on this proposal, and are finalizing the change as proposed, with one minor typographical correction.
We also sought comment on whether issuers offering coverage through SHOPs should always be required to offer average enrollee premiums, or should be required to do so only if required under applicable State law.
As discussed elsewhere in this final rule, we proposed and are finalizing substantial changes to the requirements applicable to SHOPs to provide them with the flexibility to operate in a leaner fashion, a flexibility that we will utilize in the FF-SHOPs. Among those changes, effective on the effective date of this rule, the requirements in § 156.285 will apply for plan years starting before January 1, 2018. New § 156.286 specifies those requirements contained in § 156.285 that, effective on the effective date of this rule, will continue to apply for plan years starting on or after January 1, 2018. Among those requirements is the requirement in § 156.285(e) which permits a QHP offered in the SHOP to apply group participation rules under certain circumstances. This provision will be listed in new § 156.286(e). The marketwide regulations at § 147.104(b)(1)(i)(B) currently reference § 156.285(e), and we proposed to add a reference to § 156.286(e) to clarify that, effective on the effective date of this rule, for plan years that start on or after January 1, 2018, QHPs offered in the SHOP may restrict the availability of coverage, with respect to a group health plan that cannot comply with group participation rules, to an annual enrollment period of November 15 through December 15 of each calendar year. Because we are finalizing new § 156.286(e) as proposed, we are also finalizing the proposal to reference new § 156.286(e) in § 147.104(b)(1)(i)(B).
We also proposed, and are finalizing, the removal of the small group coverage effective dates that are found in the SHOP regulations at § 155.725 with respect to plan years beginning on or after January 1, 2018, effective on the effective date of this rule. However, there are currently requirements in § 147.104(b)(1)(i)(C) that, by cross-referencing § 155.725, apply those same requirements marketwide, and we did not propose to remove that marketwide requirement. We proposed changes to § 147.104 to reflect the SHOP changes. Specifically, we proposed to eliminate, from § 147.104(b)(1)(i)(C), the cross-reference to § 155.725. We proposed in place of the cross-reference to explicitly specify in § 147.104(b)(1)(i)(C) those same coverage effective dates for coverage in the small group market, and for the large group market if such coverage is offered through a SHOP, that would be eliminated from the SHOP regulations under our proposal for § 155.725. We are finalizing this proposal, but are modifying the language that will replace the cross-reference to clarify that it is permissible for issuers to apply an effective date of coverage that is
Section 147.104(b)(2)(i) extends several of the special enrollment periods that apply to issuers on the Exchange, to all issuers in the individual market. Although § 147.104(b)(2)(i) is intended to specify which special enrollment periods offered through the Exchange must also be offered by health insurance issuers with respect to coverage offered outside of an Exchange, the paragraph as currently written could be read to apply the exceptions to any coverage offered by a health insurance issuer in the individual market. We recognize the potential for confusion, as coverage offered through an Exchange is offered by a health insurance issuer in the individual market, but this coverage is subject to the special enrollment rule at § 155.420(d), which is intended to require special enrollment periods for qualifying events including those listed in the exceptions in § 147.104(b)(2)(i). Therefore, we proposed to amend that phrase in § 147.104(b)(2)(i) to clarify that the exceptions in the paragraph only apply with respect to coverage offered outside of the Exchange in the individual market. We received no comments on this proposal, and are finalizing it as proposed.
With respect to the subset of special enrollment periods in § 155.420 that apply off-Exchange, current regulations at § 147.104(b)(2)(ii) state that, in applying § 147.104(b)(2), a reference in § 155.420 to a “QHP” is deemed to refer to a plan, a reference to “the Exchange” is deemed to refer to the applicable State authority, and a reference to a “qualified individual” is deemed to refer to an individual in the individual market. As discussed in the preamble to § 155.420, we are finalizing a change to § 155.420(a)(5) to exempt qualified individuals from the prior coverage requirement that applies to certain special enrollment periods if they lived in a service area where no qualified health plan was available through the Exchange for 1 or more days during the 60 days preceding the qualifying event or during their most recent preceding enrollment period, as specified in §§ 155.410 and 155.420. Section 155.420(a)(5) applies to qualifying individuals seeking off-Exchange coverage through an applicable special enrollment period, so we proposed that this exception for individuals living in a service area where there were no QHPs offered through an Exchange would also apply.
Among the special enrollment periods in § 155.420 that apply off-Exchange are those specified in § 155.420(d)(2)(i), under which a qualified individual gains a dependent or becomes a new dependent through marriage, birth, adoption, placement for adoption, or placement in foster care, or through a child support order or other court order. We sought comment on whether this special enrollment period should afford an individual's existing dependents an independent opportunity to enroll, off-Exchange, in new coverage or make changes to their existing coverage. As applied to on-Exchange coverage, when a qualified individual gains or becomes a new dependent under the circumstances described in § 155.420(d)(2)(i), the qualified individual is afforded a special enrollment period to enroll in or change Exchange coverage with his or her dependents, including his or her newly-gained dependent, in accordance with any applicable metal level restrictions outlined in § 155.420(a)(4)(i). The new dependent is also afforded an independent special enrollment period under which he or she can enroll in or change Exchange coverage as a subscriber, as opposed to as a dependent of the qualified individual. Under the HIPAA special enrollment provisions that continue to apply to group health plans and health insurance issuers in connection with group health coverage, there are similar special enrollment periods when a child becomes a dependent of the employee through marriage, birth, adoption, or placement for adoption.
With respect to off-Exchange coverage, we are maintaining current policy under which an individual who qualifies for a special enrollment period for gaining a dependent through marriage, birth, adoption, placement for adoption, or placement in foster care, or through a child support order or other court order under § 147.104(b)(2) may enroll in or change coverage along with his or her dependents, including the newly-gained dependent(s) and any existing dependents. The new dependent is also afforded an independent special enrollment period under which he or she can enroll in or change coverage as a subscriber, as opposed to as a dependent of the
We proposed to remove paragraph § 147.104(b)(1)(iii), along with the cross-reference to it in § 147.104(b)(1)(ii), as paragraph (b)(1)(iii) applies to plan selections made in 2013, and is therefore no longer necessary. We received no comments regarding this proposal, and are finalizing these changes as proposed.
In accordance with the OMB Report to Congress on the Joint Committee Reductions for Fiscal Year 2018,
HHS, in coordination with the OMB, has determined that, under section 256(k)(6) of the Balanced Budget and Emergency Deficit Control Act of 1985, as amended, and the underlying authority for the reinsurance and risk adjustment programs, the funds that are sequestered in fiscal year 2018 from the reinsurance and risk adjustment programs will become available for payment to issuers in fiscal year 2019 without further Congressional action. If Congress does not enact deficit reduction provisions that replace the Joint Committee reductions, these programs would be sequestered in future fiscal years, and any sequestered funding would become available in the fiscal year following that in which it was sequestered.
In subparts D and G of part 153, we established standards for the administration of the risk adjustment program. The risk adjustment program is a permanent program created by section 1343 of the PPACA that transfers funds from lower risk, non-grandfathered plans to higher risk, non-grandfathered plans in the individual and small group markets, inside and outside the Exchanges. In accordance with § 153.310(a), a State that is approved or conditionally approved by the Secretary to operate an Exchange may establish a risk adjustment program, or have HHS do so on its behalf. Beginning with the 2017 benefit year, HHS is operating risk adjustment in every State, and did not receive any applications from States to operate risk adjustment for the 2019 benefit year.
The HHS risk adjustment model predicts plan liability for an average enrollee based on that person's age, sex, and diagnoses (risk factors), producing a risk score. The HHS risk adjustment methodology utilizes separate models for adults, children, and infants to account for cost differences in each of these age groups. In each of the adult and child models, the relative risk assigned to an individual's age, sex, and diagnoses are added together to produce an individual risk score. Additionally, in the adult models, we added enrollment duration factors beginning for the 2017 benefit year, and prescription drug utilization factors (RXCs) beginning for the 2018 benefit year, in the calculation of enrollees' risk scores. Infant risk scores are determined by inclusion in one of 25 mutually exclusive groups, based on the infant's maturity and the severity of diagnoses. If applicable, the risk score for adults, children or infants is multiplied by a cost-sharing reductions adjustment.
The enrollment-weighted average risk score of all enrollees in a particular risk adjustment covered plan (also referred to as the plan liability risk score) within a geographic rating area is one of the inputs into the risk adjustment payment transfer formula, which determines the payment or charge that an issuer will receive or be required to pay for that plan. Thus, the HHS risk adjustment model predicts average group costs to account for risk across plans, which accords with the Actuarial Standards Board's Actuarial Standards of Practice for risk classification.
For the 2019 benefit year, we proposed to recalibrate the risk adjustment models using the methodology finalized for the 2018 benefit year, with small modifications to the drug classes included in the 2019 benefit year adult models, and incorporation of the 2016 benefit year enrollee-level EDGE data in the 2019 benefit year risk adjustment model recalibration.
To recalibrate the 2016, 2017 and 2018 benefit year risk adjustment models, we used the 3 most recent years of Truven MarketScan® data. This approach allowed for using the blended, or averaged, coefficients from 3 years of separately solved models, which promotes stability for the risk adjustment coefficients year-to-year, particularly for rare conditions with small sample sizes. We finalized in the 2018 Payment Notice the collection of enrollee-level EDGE data and the recalibration of the risk adjustment model for the 2019 benefit year using 2016 benefit year EDGE data. We believe that blending the coefficients calculated from the 2016 benefit year enrollee-level EDGE data with MarketScan® data will provide stability within the risk
Given the timing of the proposed rule, we were not able to incorporate the 2016 benefit year enrollee-level EDGE data in the proposed rule. Instead, we used the 2014 and 2015 MarketScan® data for the coefficients displayed in the proposed rule. We proposed to finalize the 2019 benefit year blended coefficients with the separately solved models from the 2016 benefit year enrollee-level EDGE data, and the 2014 and 2015 MarketScan® data. This is similar to our approach in previous years, in which we updated the final coefficients using data from the most recently available benefit year.
We sought comment on our proposal to determine coefficients based on a blend of 2014 and 2015 MarketScan® data and 2016 enrollee-level EDGE data. We also sought comment on the proposed methodology to equally weight the separately solved model coefficients from the 2014 MarketScan®, 2015 MarketScan®, and 2016 enrollee-level EDGE data for the final coefficients, instead of using only the 2016 enrollee-level EDGE data to recalibrate the risk adjustment model coefficients for the 2019 benefit year.
We are finalizing the approach using equally blended coefficients from separately solved 2014 MarketScan®, 2015 MarketScan®, and 2016 enrollee-level EDGE data to recalibrate the risk adjustment model coefficients for the 2019 benefit year. We are not making any changes to age-sex or HCC categories, because we did not find significant distributional differences, and we will continue to assess whether to propose any specific changes to the categories for future benefit years in future rulemaking. We did not propose and are not making any changes to the enrollment duration categories. Please see the preamble section below on “Prescription Drugs” for a discussion of changes being finalized with respect to the RXC categories. The final risk adjustment model coefficients for the 2019 benefit year risk adjustment program are listed in Tables 2, 4 and 5 of this rule.
Additionally, while Massachusetts is not included in the 2016 benefit year enrollee-level EDGE data, the relative risk differences for enrollees in Massachusetts are likely similar on average to those for enrollees in other States. The 2017 benefit year enrollee-level risk EDGE data will not be available until the end of summer 2018, after the 2019 benefit year risk adjustment factors need to be published to support 2019 benefit year benefit design and rate development, and therefore cannot be used for this recalibration effort. We believe that a national dataset of individual and small group market claims experience for the most recent benefit year is the preferable data source—even without the incorporation of one State—compared to only using commercial claims data for risk adjustment model recalibration and risk estimation in the individual and small group markets.
In all, we believe blending the coefficients promotes stability and certainty for issuers in rate setting, smoothing any significant differences as with the EDGE enrollment duration factors, while maintaining the relative average risk differences stakeholders have expected from the MarketScan®-only coefficients. Therefore, we are finalizing our proposal to equally weight coefficients from separately solved models using 2014 MarketScan®, 2015 MarketScan®, and 2016 enrollee-level EDGE data for the final 2019 benefit year risk adjustment model recalibration. We also were able to complete our analysis of the 2016 EDGE data in time to publish the final coefficients blended with 2016 enrollee-level EDGE data in this final rule. The final 2019 benefit year risk adjustment model coefficients listed in Tables 2, 4, and 5 are blended coefficients using equally weighted coefficients solved from the 2014 MarketScan®, 2015 MarketScan®, and 2016 enrollee-level EDGE data.
In the 2018 Payment Notice, we finalized the inclusion of 12 RXCs that interact with HCCs, or drug-diagnosis (RXC-HCC) pairs, in the adult risk adjustment models for the 2018 benefit year. Ten of the RXC-HCC pairs have three levels of incremental predicted costs (diagnosis-only, prescription drug-only, and both diagnosis and prescription drug), indicating that they can be used to impute a particular diagnosis. The 2018 benefit year risk adjustment adult models also included two RXC-HCC pairs that are used for severity-only—that is, they predict incremental costs for enrollees with the diagnosis-only, or with both the diagnosis and the prescription drug. For enrollees without the associated diagnoses documented for these severity-only RXC-HCC pairs, the presence of the drug alone would not lead to the attribution of additional plan liability costs to the plan.
For the 2019 benefit year, we proposed to remove the two severity-only RXCs (RXC 11: Ammonia Detoxicants, and RXC 12: Diuretics, Loop and Select Potassium-Sparing). Both have low average costs per enrollee per year and were constrained in the 2018 benefit year adult risk adjustment models final coefficients to the average cost of the drugs to avoid overcompensating issuers for these RXCs. Constraining these RXCs removed overprescribing and gaming incentives to prescribe a low-cost drug to receive a much larger risk adjustment payment. However, after constraints, these two severity-only RXCs have extremely small coefficients that no longer predict meaningful incremental plan risk associated with a severe health condition. Therefore, we proposed eliminating these two RXCs from the adult models beginning with the 2019 benefit year. As explained in the proposed rule, we believe the remaining RXCs do not engender significant gaming concerns due to the cost and side-effects of the drugs if prescribed
2018 Benefit Year HHS-Operated Risk Adjustment Adult Models Draft Prescription Drug (RXCUIs) to HHS Drug Classes (RXCs) Crosswalk. September 18, 2017. Available at
We review drugs in the United States Pharmacopeia (USP) classification and consult clinicians and experts to ensure relevant drugs are included. However, as some commenters noted in response to the proposed rule, new drugs have been released since we released the draft 2018 benefit year crosswalk and a few drugs that may be eligible under our other criteria were not classified by the USP classification version used for the draft crosswalk. We expect to publish the final 2018 benefit year crosswalk in the spring of 2019, after the conclusion of the 2018 benefit year, so that newly approved drugs released through the end of the year and the latest USP classification are evaluated and included, as appropriate. As such, we intend to make quarterly updates to the 2018 benefit year prescription drug crosswalk, to ensure we are capturing all new drug releases and drug class inclusions or modifications. We are also reviewing drugs administered through clinicians in hospital, office-based, or
HHS finalized a high-cost risk pool adjustment in the 2018 Payment Notice to account for the incorporation of risk associated with high-cost enrollees in the risk adjustment model. Specifically, we finalized adjusting the risk adjustment model for high-cost enrollees beginning for the 2018 benefit year by excluding a percentage of costs above a certain threshold level in the calculation of enrollee-level plan liability risk scores so that risk adjustment factors are calculated without the high-cost risk, because the average risk associated with HCCs and RXCs is better accounted for without the inclusion of the high-cost enrollees. In addition, to account for issuers' risk associated with the high-cost enrollees, issuers will be compensated for a percentage of costs above the threshold. We set the threshold and percentage of costs at a level that would continue to incentivize issuers to control costs while improving the risk prediction of the risk adjustment model. Issuers with high-cost enrollees will receive a payment for the percentage of costs above the threshold in their respective transfers. Using claims data submitted to the EDGE server by issuers of risk adjustment covered plans, HHS will calculate the total amount of paid claims costs for high-cost enrollees based on the threshold and the coinsurance rate. HHS will then calculate a charge as a percentage of the issuers' total premiums in the individual (including catastrophic and non-catastrophic plans and merged
For the 2019 benefit year, we proposed to maintain the same parameters that apply to the 2018 benefit year. Therefore, we proposed to maintain a $1 million threshold and 60 percent coinsurance rate for the high-cost risk pool for the 2019 benefit year risk adjustment program. We explained that we believe this threshold and coinsurance rate would result in total payments or charges nationally that are very small as a percentage of premiums for issuers, and will prevent States and issuers with very high-cost enrollees from bearing a disproportionate amount of unpredictable risk. We sought comments on alternative methods for reimbursing issuers for exceptionally high-cost enrollees through the high-cost risk pool and improving the calculation of plan liability in the HHS-operated risk adjustment models for future benefit years. We also shared suggestions from stakeholders that the pool be multi-tiered, with multiple thresholds and increased coinsurance as the thresholds increase to account for the reduced number of enrollees at higher thresholds where costs to an issuer are catastrophic.
We are finalizing the high-cost risk pool adjustment parameters for the 2019 benefit year as proposed.
We are finalizing our proposal to maintain a $1 million threshold and 60 percent coinsurance rate for the high-cost risk pool for the 2019 benefit year risk adjustment program.
The final factors resulting from the equally weighted blended factors from the 2014 and 2015 MarketScan® data and the 2016 enrollee-level EDGE data separately solved models (with the incorporation of the partial year enrollment adjustment and prescription drugs reflected in the adult models only) are shown in Tables 2, 4, and 5. The adult, child and infant models have been truncated to account for the high-cost enrollee pool payment parameters by removing 60 percent of costs above the $1 million threshold as finalized in this rule. As discussed in the preceding section, we are finalizing our proposal to keep the 2019 benefit year high-cost enrollee risk pool payment parameters the same as those finalized for the 2018 benefit year. The final factors for the adult models also reflect the removal of the two severity-only RXCs (RXC 11: Ammonia Detoxicants, and RXC 12: Diuretics, Loop and Select Potassium-Sparing) discussed above in the preamble section on “Prescription Drugs.” Table 2 contains factors for each adult model, including the age-sex, HCCs, RXCs, HCC-RXC interaction, and enrollment duration coefficients. As we previously noted,
Table 3 contains the HHS HCCs in the severity illness indicator variable. Table 4 contains the factors for each child model. Table 5 contains the factors for each infant model. Tables 6 and 7 contain the HCCs included in the infant model maturity and severity categories, respectively.
We proposed to continue including an adjustment for the receipt of cost-sharing reductions in the model to account for increased plan liability due to increased utilization of health care services by enrollees receiving cost-sharing reductions (induced demand) in all States where HHS operates risk adjustment. The proposed cost-sharing reductions adjustment factors for the 2019 benefit year were unchanged from those finalized in the 2018 Payment Notice. These adjustments would be effective for 2016, 2017, 2018, and 2019 risk adjustment, and would be multiplied against the sum of the demographic, diagnosis, and interaction factors, and enrollment and prescription drug utilization factors (for the adult models). We are finalizing the cost-sharing reductions adjustment factors as proposed. See Table 8 for the list of final cost-sharing reductions adjustments for the 2019 benefit year.
To evaluate model performance, we examined each model's R-squared statistic and predictive ratios. The R-squared statistic, which calculates the percentage of individual variation explained by a model, measures the predictive accuracy of the model overall. The predictive ratios measure the predictive accuracy of a model for different validation groups or subpopulations. The predictive ratio for each of the HHS risk adjustment models is the ratio of the weighted mean predicted plan liability for the model sample population to the weighted mean actual plan liability for the model sample population. The predictive ratio represents how well the model does on average at predicting plan liability for that subpopulation. A subpopulation that is predicted perfectly would have a predictive ratio of 1.0. For each of the HHS risk adjustment models, the R-squared statistic and the predictive ratios are in the range of published estimates for concurrent risk adjustment models.
We previously defined the calculation of plan average actuarial risk and the calculation of payments and charges in the Premium Stabilization Rule. In the 2014 Payment Notice, we combined those concepts into a risk adjustment payment transfer formula. Risk adjustment transfers (total payments and charges including high-cost risk pool payments and charges) will be calculated after issuers have completed risk adjustment data reporting. The payment transfer formula includes a set of cost adjustment terms that require transfers to be calculated at the geographic rating area level for each plan (that is, HHS will calculate separate transfer amounts for each rating area in which a plan operates).
The risk adjustment transfer formula generally calculates the difference between the revenues required by a plan, based on the health risk of the plan's enrollees, and the revenues that a plan can generate for those enrollees. These differences are compared across plans in the State market risk pool and converted to a dollar amount based on the Statewide average premium. Thus, each plan in the risk pool receives a risk adjustment payment or charge designed to compensate for risk for a plan with average efficiency. Scaling the risk adjustment transfers by the Statewide average premium, as opposed to, for example, the plan's own premium, minimizes issuers' ability to manipulate their transfers by adjusting their own plan premiums, and results in a calculation of equal payments and charges, ensuring that risk adjustment transfers for the entire market sum to zero.
In the absence of additional funding, we established, through notice and comment rulemaking,
The State payment transfer formula in the HHS risk adjustment methodology is designed to provide a per member per month (PMPM) transfer amount. The PMPM transfer amount derived from the State payment transfer formula would be multiplied by each plan's total billable member months for the benefit year to determine the total payment due to or charge owed by the issuer for that plan in a rating area. The total payment or charge is thus calculated to balance the State market risk pool in question.
In addition to the total charge or payment assessed for an issuer in a State market risk pool based on plan liability risk scores, in the 2018 Payment Notice, we added to the risk adjustment methodology additional transfers that would reflect the payments and charges assessed with respect to the high-cost risk pool. To account for costs associated with exceptionally high-risk enrollees, we added transfer terms (a payment term and a charge term) that would be calculated separately from the State transfer formula in the HHS risk adjustment methodology. Beginning for the 2018 benefit year, we added one term that reflects 60 percent of costs above $1 million (
For the 2019 benefit year, we are finalizing the proposed policy to maintain this adjustment to the risk adjustment transfers with the threshold of $1 million and a coinsurance rate of 60 percent, as finalized for the 2018 benefit year.
Additionally, we proposed to continue the policy finalized in the 2018 Payment Notice to reduce the Statewide average premium, the cost scaling factor in the risk adjustment transfer formula, by 14 percent to account for the proportion of administrative costs that do not vary with claims for the 2019 benefit year and future benefit years until changed in rulemaking. As a note, we have previously defined the cost scaling factor, or the Statewide average premium term, as the sum of average premium per member month of plan (
We are finalizing the policy to reduce the Statewide average premium in the risk adjustment formula by 14 percent, as proposed, for the 2019 benefit year and future benefit years until changed in rulemaking.
The HHS risk adjustment payment transfer formula generally transfers amounts from issuers with lower than average actuarial risk to those with higher than average actuarial risk. Risk adjustment is widely used in health insurance markets, and is recognized as a critical measure in mitigating the effects of adverse selection, ensuring financial viability of plans that enroll a higher proportion of high-risk enrollees, and fostering competitive health insurance markets. The State transfer formula in the HHS-operated risk adjustment program is scaled with the Statewide average premium in the applicable State market. In the 2018 Payment Notice, we noted that compared to other scaling factors, such as plans' own premiums, our analyses found that the Statewide average premium proves to be a more appropriate means of scaling the transfers for differences in relative actuarial risk, particularly in the context of a budget-neutral system. As noted in the above section, beginning with the 2018 benefit year, we also adopted an administrative cost adjustment to the Statewide average premium to remove a portion of administrative costs that did not vary based on claims differences from the Statewide average premium and base the transfers on the portion of the premiums that vary with claims.
In the case of small group markets, where States can demonstrate that the differential risk profiles observed in the small group market plans in that State are attributable to factors other than systematic risk selection, and adverse selection risk is mitigated by the small group market dynamics, such as those described above, we proposed to permit States' primary insurance regulators to request a percentage reduction in the calculation of the risk adjustment transfer amounts in the small group market in their State, beginning for the 2019 benefit year.
We proposed that HHS would require any State that seeks this flexibility to submit its proposal for an adjustment to the Statewide average premium in the small group market within 30 calendar days after publication of the proposed HHS notice of benefit and payment parameters for the applicable benefit year, in order to permit issuers to incorporate any such adjustment into their proposed rates. In order to promote transparency and solicit feedback from consumers and stakeholders on the proposed reductions to the HHS risk adjustment transfer formula, we proposed HHS would publish the requested State reduction percentages for public comment in guidance while it begins its initial review of the State requests. We proposed that HHS would then make final determinations on State requests by March 1 of the benefit year prior to the applicable benefit year, in time for issuers' initial rate setting deadline. The proposed timing of the State adjustment request, publication of HHS guidance setting forth the requested State reduction percentages, public notice and comment period and HHS approval process would permit plans to incorporate approved adjustments in their rates for the applicable benefit year.
Under the proposal, HHS would consider requests from State regulators to reduce the calculation of the Statewide average premium used in the HHS risk adjustment transfer formula in the small group market by up to 50 percent for the applicable benefit year. We sought comment on all aspects of this proposal for the small group market, including the size of the reduction, the timing of the request submission, what evidence States should be required to provide, and what procedural requirements should be established.
We also sought comment on whether we should establish a similar process through which States could request a reduction to the calculation of risk adjustment transfers in the individual market. Although adverse selection in the individual market is not mitigated by group enrollment or minimum participation requirements as is the selection in the small group market, we recognized that a State may believe the HHS risk adjustment methodology, which is calibrated on a national dataset, may not precisely account for relative actuarial risk differences in its individual market risk pool. We sought comment on whether, if a State can demonstrate such a difference in calculated relative actuarial risk, we should reduce States' administrative burden in operating its own risk adjustment program by allowing some flexibility in the HHS risk adjustment methodology to the extent permissible under the statute. Therefore, we sought comment on what individual market features would justify such a reduction, and what additional submissions a State should provide in order to justify such a departure for that market.
We recognize that it is possible the HHS risk adjustment methodology, which is calibrated on a national dataset and does not take into account State-specific rules or market dynamics, may not precisely account for relative actuarial risk differences in certain States' individual, small group or merged markets, and those State-specific rules or other relevant factors could support a reduction to transfers in that State's individual, small group or merged market. To accommodate situations where there may be such differences in State factors compared to the national norm, HHS is finalizing the policy to provide States the flexibility to request a reduction to the otherwise applicable risk adjustment transfers in the individual, small group or merged market by up to 50 percent with some modifications, outlined below, in response to comments. In States that request a reduction to transfers, the reduction percentage up to 50 percent, if approved by HHS, would be applied to the plan PMPM payment or charge transfer amount (T
The approved reductions will be made on the calculated risk adjustment transfer amounts, rather than the Statewide average premium as proposed, prior to the application of the high-cost risk pool adjustments (high-cost risk pool payment and charge amounts). Applying the reduction is simply a mathematical operation and applying it on the otherwise calculated transfer amounts will result in the same final transfer amount mathematically as if the reduction was applied to the Statewide average premium, but will simplify the process for submission, review and calculation of the reductions to transfers.
We are finalizing modified timelines and adding paragraphs (d)(2) and (d)(3) at § 153.320 to capture the timeframe for submission and publication of State requests to reduce transfers in the individual, small group and merged markets in response to comments. We are not finalizing this proposed policy for the 2019 benefit year, in order to accommodate the evidence and analysis required and to provide more time for the development and review of such requests. Additionally, we believe the requests should be published in the relevant benefit year's proposed HHS notice of benefit and payment parameters to seek comment from relevant stakeholders. As such, consistent with paragraph (d)(2), beginning with 2020 and future benefit years, States must submit requests with the supporting evidence and analysis by August 1st, 2 calendar years prior to the beginning of the applicable benefit year (for example, August 1, 2018, for the 2020 benefit year) to
Several commenters supported the reduction to transfers only for the small group market, noting that the adverse selection in the individual market requires the risk adjustment program to ensure competitive and stable markets. These commenters noted such a reduction to transfers would be detrimental to market stability in the individual market, with one commenter noting that unexpectedly large charges were a risk for issuers in the early years of the program and the markets have since stabilized. A few commenters noted that HHS should allow States to permit reductions in merged markets as well, while others noted this policy should not be made available in merged markets given the impact on individual market dynamics in the merged market States. Yet a few commenters suggested the flexibility be allowed across the individual, small group and merged markets. One commenter noted that such a reduction would be appropriate in the individual market as well to reduce carrier-specific transfers to adjust for administrative costs, limit distortions due to how many family members are counted toward premiums, or prevent perverse incentives to avoid care management or network variations that lower costs.
Other commenters did not support a reduction to the risk adjustment transfers, stating the reduction to
We appreciate commenters' concerns about extending the flexibility to the individual or merged markets. We believe that those enrolled in the individual or merged markets typically have higher actuarial risk, risk selection, and risk segmentation in plan selection than those enrolled in the small group market, and risk adjustment transfers are particularly required in these markets to mitigate issuers' risk of adverse selection and incentives to avoid risk. However, we recognize that, just as with certain States' small group markets, it is possible that certain factors unique to the States' individual or merged market, such as State rating requirements, could support a reduction to transfers in that State market, and therefore are finalizing the State flexibility to request reduction to otherwise applicable risk adjustment transfers in the individual and merged markets as well. We note that guaranteed availability, guaranteed renewability, as well as the non-discrimination provisions at §§ 147.104(e), 147.110 and 156.125(a), provide protections against potential employment of marketing practices or benefit designs that have the effect of avoiding less healthy employer groups, discriminating based on health conditions, or otherwise discouraging enrollment of individuals with significant health needs. Finally, allowing for the State flexibility for the 2020 benefit year, will allow us to assess
The finalized State payment transfer formula for the 2019 benefit year is unchanged from what was finalized in the 2014 Payment Notice (78 FR 15430 through 15434). We believe it useful to republish the formula in its entirety. Transfers (payments and charges) will be calculated as the difference between the plan premium estimate reflecting risk selection and the plan premium estimate not reflecting risk selection. The State payment transfer calculation that is part of the HHS risk adjustment payment transfer formula is:
The difference between the two premium estimates in the State payment transfer calculation determines whether a plan pays a risk adjustment charge or receives a risk adjustment payment. The value of the plan average risk score by itself does not determine whether a plan would be assessed a charge or receive a payment—even if the risk score is greater than 1.0, it is possible that the plan would be assessed a charge if the premium compensation that the plan may receive through its rating (as measured through the allowable rating factor) exceeds the plan's predicted liability associated with risk selection. Risk adjustment transfers are calculated at the risk pool level, and catastrophic plans are treated as a separate risk pool for purposes of the risk adjustment transfer calculation, not including the national high-cost risk pool payments and charges. This resulting PMPM plan payment or charge is multiplied by the number of billable member months to determine the plan payment or charge based on plan liability risk scores for a plan's geographic rating area for the risk pool market within the State.
Beginning with the 2018 benefit year, the high-cost risk pool adjustment amount will be added to the plan transfers (payment or charge) to account for: (1) The payment term, representing the portion of costs above the threshold reimbursed to the issuer for high-cost risk pool payments (
With the high-cost risk pool adjustment amount, the total plan transfers would be calculated as the product of the plan PMPM transfer amount (T
HHS will conduct risk adjustment data validation under § 153.630 in any State where HHS is operating risk adjustment on a State's behalf.
Under § 153.350(c), HHS may adjust risk adjustment payments and charges to all issuers of risk adjustment covered plans based on adjustments to the average actuarial risk of a risk adjustment plan due to errors discovered during risk adjustment data validation. Under the original risk adjustment data validation payment adjustment approach, all issuers of risk adjustment covered plans would receive an adjustment to payment transfers in the subsequent benefit year based on risk adjustment data validation audit results and using the audit-confirmed, issuer-specific risk score error rate. However, we believe that some variation and error should be expected in the compilation of data for risk scores, because providers' documentation of enrollee health status varies across provider types and groups. Our experiences with the Medicare Advantage risk adjustment data validation program and the HHS risk adjustment data validation pilot for the 2015 benefit year reinforce this belief.
To avoid adjusting all issuers' risk adjustment payments for expected variation and error, we proposed evaluating material statistical deviation in error rates beginning with 2017 benefit year risk adjustment data validation. In the proposed rule, we explained that we were considering adjusting an issuer's risk score only when the issuer's error rate materially deviates from a statistically meaningful value, such as the central tendency (a mean or typical value) of errors, nationally. When an error rate materially deviates from the central tendency, we proposed to apply the difference between the mean error rate or the confidence interval around the population's central tendency and the calculated error rate instead of the full error rate. If all error rates in a State risk pool do not materially deviate from the national central tendency of error rates, we proposed to not apply any adjustments to issuers' risk scores for that benefit year in the respective State risk pool.
We also noted that alternatively, HHS could evaluate error rates within each HCC, or groups of HCCs, and then only apply error rates to outlier issuers' risk scores within each HCC or group of HCCs. In evaluating the “error rate” of HCCs, or groups of HCCs, we mean the probability of an assigned HCC being found to be incorrect based on the risk adjustment data validation audit, or a “failure rate.” The percent of the EDGE risk score that is incorrect due to audit findings (that is, due to HCCs that could not be validated through audit), we consider to be the issuer's risk score error rate. For example, an issuer could have a 50 percent failure rate for an HCC, in that two of four instances of the HCC on EDGE could not be validated. The impact of HCC failure rates on an issuer's error rate will then depend on the magnitude of the missing HCC's coefficient and the incidence of that HCC in the audit sample.
We believe the implementation of any of the alternative evaluations and subsequent adjustments we proposed would streamline the risk adjustment data validation process, improve issuers' ability to predict risk adjustment transfers, and promote confidence and stability in the budget-neutral payment transfer methodology, while ensuring the integrity and quality of data provided by issuers.
We are finalizing the approach described above of using failure rates specific to HCC groups and subsequently adjusting the issuer's risk score when the issuer's failure rate for a group of HCCs is statistically different from the weighted mean failure rate, or total failure rate, for that group of HCCs for all issuers that submitted initial validation audits. We are selecting this approach based on comments received, which generally were more supportive of the HCC or HCC-grouping methodology for evaluating failure rates than an approach under which we would calculate a national overall error rate. Additionally, we believe determining outlier failure rates based on HCC groups mitigates gaming concerns raised by commenters in using a national error rate, and mitigates commenters' sample size concerns in using HCC-specific failure rates. Our simulations of failure rates by HCC group suggest that such an approach yields a more equitable measure to evaluate statistically different HCC failure rates affecting an issuer's error rate than an approach based on an overall failure rate, which may overly adjust issuers with abnormal distributions of certain HCCs due to their underlying populations rather than differences due to errors in diagnoses codes. Illustrations of the methodology we will use to evaluate failure rate differences by HCC group, calculate error rates based on failure rates, and apply error rates to risk scores are provided below.
Using data from the 2017 benefit year risk adjustment data validation, HHS will first calculate the failure rate for each HCC in issuers' initial validation audit samples as:
HHS will then create three HCC groups based on the HCC failure rates derived in the calculation above. These HCC groups will be determined by first ranking all HCC failure rates and then dividing the rankings into three groups, weighted by total observations or frequencies, of that HCC across all issuers' initial validation audit samples, to assign each unique HCC in the initial validation audit samples to a high, medium, or low failure rate group with an approximately even number of observations in each group. That is, each HCC group may have an unequal number of unique HCCs, but the total
HHS will then compare each issuer's failure rate for each HCC group based on the number of HCCs validated in the initial validation audit, compared to the number of HCCs recorded on EDGE within that HCC group for the initial validation audit sample enrollees. The issuer's HCC group failure rate will be compared to the weighted mean failure rate, or total failure rate, for that HCC group. We calculate an issuer's HCC group failure rate as:
We will also calculate the weighted mean failure rate and the standard deviation of each HCC group as:
When an issuer's HCC group failure rate is an outlier, we will reduce (or increase) each of the applicable initial validation audit sample enrollees' HCC coefficients by the difference between the outlier issuer's failure rate for the HCC group and the weighted mean failure rate for the HCC group. Specifically, this will result in the sample enrollees' applicable HCC risk score components being reduced (or increased) by a partial value, or percentage, calculated as the difference between the outlier failure rate for the HCC group and the weighted mean failure rate for the applicable HCC group. The adjustment amount for outliers will be the distance between issuer
The adjustment to an enrollee's total risk score is calculated as the ratio of the total adjusted risk score for individual HCCs to the total risk score components for individual HCCs. For example, if an issuer has one enrollee with the HIV/AIDS HCC and the issuer's HCC group adjustment rate is 10 percent (the difference between the issuer's group failure rate and the weighted mean failure rate) for the HCC group that contains the HIV/AIDS HCC, the enrollee's HIV/AIDS coefficient would be reduced by 10 percent. We calculate the total adjustment amount across all HCCs per enrollee as:
We will then calculate an issuer's error rate using the EDGE risk score and adjusted risk score for all enrollees in the sample (excluding enrollees with no HCCs). The weight
The risk score error rate would then be applied to the subsequent benefit year calculated plan level risk scores, to adjust the issuer's plan level risk scores before risk adjustment transfers are calculated, unless the issuer exited the market during or at the end of the benefit year being audited.
In the 2015 Payment Notice, we established that HHS will use a prospective approach to adjust risk scores and payment transfers based on the results of risk adjustment data validation. Specifically, HHS will apply the error rate calculated through the risk adjustment data validation process for the applicable benefit year to plan risk scores in the subsequent benefit year, and then make risk adjustment payment transfers based on adjusted plan average risk scores in that subsequent benefit year. However, in some cases, an issuer of a risk adjustment covered plan may have exited a State market during or at the end of the benefit year being audited and therefore would not have risk scores or payment transfers in the subsequent benefit year to which HHS could make adjustments.
As previously noted, the purpose of risk adjustment data validation is to promote confidence in the budget-neutral payment transfer methodology by ensuring the integrity and quality of data provided from issuers. HHS believes that the prospect of not receiving payment adjustments based on the results of risk adjustment data validation results could undermine these goals by eliminating the incentive for an exiting issuer to carefully and accurately submit risk adjustment data for its final benefit year in the market. Not only could this type of inaccuracy result in overpayments to the exiting issuer, it could also cause the other issuers in the market to be over or undercompensated for the actual risk of their enrollee populations. Therefore, we proposed that HHS would use the error rate derived from the risk adjustment data validation process to adjust the payment transfer for the issuer's final benefit year in the State market, which would be concurrent with the benefit year being audited, for issuers that exit a State market during or at the end of the benefit year being audited. Because risk adjustment transfers for a given benefit year are calculated and paid before the risk adjustment data validation process for that benefit year is completed, this approach would require HHS to make a retroactive (that is, post-transfer) adjustment to the issuer's payment transfer for its final benefit year and reallocate the adjusted transfer amount to the other issuers in the State market in that year.
We sought comment on this proposal to make these adjustments to payment transfers for issuers that have exited the market based on the results of risk adjustment data validation for the most recent benefit year in which they participated in risk adjustment. We are finalizing this policy as proposed, and we clarify that it will be effective beginning with the 2017 benefit year risk adjustment data validation. Therefore, for an issuer that exited a State market during or at the end of the 2017 benefit year who had a statistically meaningful error rate under the revised approach to payment adjustments finalized above in this rule, HHS would apply the risk score error rate to the issuer's 2017 benefit year risk score, and recalculate 2017 benefit year risk adjustment transfers for the affected State market risk pools. We note that, under this timeline, issuers that exited a State market during or at the end of 2017 benefit year have ample opportunity to review and correct data submitted to their EDGE servers that will be used to calculate risk scores for the 2017 benefit year.
Numerous small issuers have expressed concern regarding the regulatory burden and cost associated with complying with the risk adjustment data validation program. HHS has previously considered these concerns and provided relief where possible. In the proposed rule, we proposed that, beginning with 2017 benefit year risk adjustment data validation, issuers with 500 billable member months or fewer that elect to establish and submit data to an EDGE server would not be subject to the requirement to hire an initial validation auditor or submit initial validation audit results. We explained that we believe exempting issuers with 500 billable member months or fewer from the requirement to hire an initial validation auditor is appropriate because issuers of this size would have a disproportionately high operational burden for compliance with risk adjustment data validation. We noted that, beginning with 2018 benefit year risk adjustment data validation, these issuers would not be subject to random sampling under the materiality threshold discussed below, and would continue to not be subject to the requirement to hire an initial validation auditor or submit initial validation audit results. We also explained that if the approach for payment adjustments for error rates outlined in the proposed rule were finalized, then it would be possible that no adjustment would occur for issuers below this threshold. We sought comments on the proposal, including the 500 billable member month threshold.
We are finalizing the exemption for issuers with 500 billable member months or fewer as proposed. We clarify that, consistent with the approach in the 2017 Payment Notice for the lower, separate risk adjustment default charge for small issuers, the determination of whether an issuer has 500 billable member months or fewer will be calculated Statewide (that is, combining an issuer's enrollment in a State's individual and small group markets in a benefit year).
In the 2018 Payment Notice, HHS implemented a materiality threshold for risk adjustment data validation to ease the burden of annual audit requirements for smaller issuers of risk adjustment covered plans. Specifically, we stated that issuers with total annual premiums at or below $15 million (calculated based on the premiums of the benefit year being validated) would not be subject to
We are finalizing the postponement of the materiality threshold to 2018 benefit year risk adjustment data validation, as proposed.
Section 153.350(a) requires that a statistically valid sample of enrollees from each issuer of risk adjustment covered plans be validated. In the 2015 Payment Notice, HHS finalized its methodology for selecting the sample of enrollees for the initial validation audit for each issuer of a risk adjustment covered plan. We established a sample size per issuer for each State in which the issuer offers risk adjustment covered plans.
Under § 153.630(b)(6), the issuer of a risk adjustment covered plan must provide the initial validation auditor and second validation auditor with all relevant source enrollment documentation, all claims and encounter data, and medical record documentation from providers of services to each enrollee in the applicable sample without unreasonable delay and in a manner that reasonably assures confidentiality and security in transmission. Issuers have advised HHS that certain States' medical privacy laws may limit providers' ability to furnish mental and behavioral health records for risk adjustment data validation purposes. As we explained in the proposed rule, we believe that section 1343 of the PPACA and associated regulations require issuers of risk adjustment covered plans to furnish any records needed for purposes of the risk adjustment program, including mental and behavioral health records, and that the HIPAA Privacy Rule at 45 CFR 164.512(a) generally permits disclosures of protected health information that are required by law within the meaning of § 164.103. Nevertheless, we recognize that some State and Federal privacy laws impose requirements for mental and behavioral health information that are different from, and potentially more restrictive than, the HIPAA regulations. However, without the necessary mental and behavioral health information, the diagnosis code for an applicable enrollee cannot be validated and, therefore, it would be rejected during risk adjustment data validation.
To address these potential issues, we proposed to amend § 153.630(b)(6) to provide that, if a provider is prohibited from furnishing a full mental or behavioral health record by State or Federal privacy laws, the provider instead may furnish a mental or behavioral health assessment that providers routinely prepare, for validation of a mental or behavioral health diagnosis. We explained that, although HHS needs the full content of the mental or behavioral health record to ensure full validation of the accuracy of diagnosis codes, we believed that we can still perform some risk adjustment data validation based on the information contained in mental or behavioral health assessments in those instances in which State or Federal law prohibits submission of the full record. For risk adjustment data validation purposes, we would expect a mental or behavioral health assessment to be signed by a qualified provider who is licensed by the State to diagnose mental illness and, to the extent permissible under governing privacy and confidentiality laws, to contain: (i) The enrollee's name; (ii) sex;
We noted the proposal would allow issuers an additional avenue to achieve compliance by permitting abbreviated mental or behavioral health assessments for risk adjustment data validation in the event that a provider is subject to State or Federal privacy laws that prohibit the provider from providing a complete mental or behavioral health record to HHS. Under the proposal, to submit a mental or behavioral health assessment instead of the full mental or behavioral health record, a provider would be required to attest that relevant State or Federal privacy laws prohibit him or her from providing the complete mental or behavioral health record. We explained in the proposed rule that we also believed that the proposal supports the integrity of the risk adjustment data validation program by ensuring that an initial validation auditor obtains data that will enable proper validation of mental or behavioral health HCCs, which are susceptible to discretionary coding. Furthermore, we noted our belief that the flexibility to use mental or behavioral health assessments would minimize the burden on providers of complying with this requirement because providers may be able to utilize records they routinely prepare and may already have, as opposed to preparing special summaries solely for the purpose of risk adjustment data validation.
Based on our review of the comments we received, we are generally finalizing the amendments to § 153.630(b)(6) to permit providers that are prohibited by State law from furnishing a full mental or behavioral health record to submit an assessment instead. We are making one clarification to convey that this flexibility will not apply to providers that are prohibited solely by Federal law from furnishing a full mental or behavioral health record. We recognize that other State and Federal laws, including the Federal confidentiality law at 42 U.S.C. 290dd-2 and associated regulations that govern certain patient substance use disorder records potentially apply to mental or behavioral health assessments, and would require a provider to obtain enrollee consent before disclosing the assessment if applicable. We reiterate that the proposal on mental or behavioral health assessments was not intended to provide an exception to any applicable enrollee consent requirement under State or Federal law.
HHS recognizes, however, that our policy to allow providers to furnish a mental or behavioral health assessment may impose a slight increase in the burden of compliance with risk adjustment data validation requirements because the assessment must be accompanied by an attestation from the provider. Attestations are necessary to demonstrate that the provider is prohibited from furnishing the complete medical record by State privacy laws, but we do not expect compliance with the attestation requirement to be difficult.
As noted above, HHS does not intend to exempt providers from any other applicable consent requirements under State or Federal law, and we do not yet have adequate experience as to whether failure rates will be higher for mental health conditions or substance use disorders. We reiterate that only issuers with statistically meaningful failure rates will receive risk score error rates and subsequent payment transfer adjustments pursuant to the policy finalized in this rule.
As discussed in the 2018 Payment Notice, in specific instances, risk adjustment permits the use of prescription drugs to impute diagnoses. As noted elsewhere in this rule, HHS will continue to evaluate the inclusion of additional prescription drug classes in the risk adjustment model, including mental or behavioral health treatments, to potentially impute missing diagnoses for future benefit years.
Under § 153.630(b)(8), the initial validation auditor must measure and report to the issuer and HHS, in a manner and timeframe specified by HHS, its inter-rater reliability rates among its reviewers. An initial validation auditor must achieve a consistency measure of at least 95 percent for his or her review outcomes, except for the initial benefit years of risk
An effective risk adjustment data validation program is essential to the proper functioning of the HHS-operated risk adjustment program. In order to enforce risk adjustment data validation standards when operating risk adjustment data validation on behalf of a State, we proposed to clarify and amend the bases upon which HHS may impose CMPs for violations of risk adjustment data validation requirements.
To give HHS additional flexibility for ensuring compliance with the risk adjustment data validation requirements and in light of our experience in the first pilot year of the risk adjustment data validation program, HHS proposed to amend § 153.630(b)(9) to give HHS the authority to impose a CMP on an issuer of a risk adjustment covered plan in the event of misconduct or substantial non-compliance with the risk adjustment data validation standards and requirements. Specifically, we proposed to amend § 153.630(b)(9) to state that, if an issuer of a risk adjustment covered plan (1) fails to engage an initial validation auditor; (2) fails to submit the results of an initial validation audit to HHS; (3) engages in misconduct or substantial non-compliance with the risk adjustment data validation standards and requirements applicable to issuers of risk adjustment covered plans; or (4) intentionally or recklessly misrepresents or falsifies information that it furnishes to HHS, HHS may impose CMPs in accordance with the procedures set forth in § 156.805(b) through (e). We note that § 153.630(b)(9) already addresses the possible imposition of CMPs for (1) and (2) above, and provides a cross-reference to § 156.805, which contains the bases and procedures for imposing CMPs for (3) and (4) above. Section 153.630(b)(9) provides the authority to assess CMPs on all issuers of risk adjustment covered plans, not just issuers on an FFE as does § 156.805.
As previously noted in the Second 2013 Program Integrity Rule, and in the 2015 Payment Notice, we proposed that HHS's possible application of CMPs would continue to take into account the totality of the issuer's circumstances, including such factors as an issuer's previous record of non-compliance (if any), the frequency and level of the violation, and any aggravating or mitigating circumstances. Additionally, we would continue to impose any CMPs so that the level of the enforcement action is proportional to the level of the violation. While we reserved the right to impose penalties up to the maximum amounts set forth in § 156.805(c), as a general principle, we explained that we intend to work collaboratively with issuers to address any problems in conducting the risk adjustment data validation process.
We believe this additional CMP authority will improve program integrity and fairness by permitting HHS the authority to assess CMPs on issuers that engage in misconduct in risk adjustment data validation. Although § 153.630(e) permits HHS to adjust payments and charges for issuers that do not comply with audit requirements and standards, this provision only makes the markets whole in the event of a violation of the risk adjustment data validation standards or misconduct. We do not believe this provision provides a sufficient deterrent effect to ensure program integrity of the risk adjustment data validation program. Additionally, we believe this additional authority is necessary in light of the policies finalized in the 2018 Payment Notice, specifically, the concerns HHS highlighted around gaming and the inclusion of prescription drug data in the risk adjustment model. We are finalizing as proposed the amendments to § 153.630(b)(9) to clarify and strengthen HHS's CMP authority. We also clarify that HHS would not impose a CMP under § 153.630(b)(9) for a benefit year on an issuer that is not required to submit an initial validation audit for risk adjustment data validation for that benefit year.
On September 2, 2015, HHS released the
An overstatement or understatement of premium data may affect issuers differently, because it will lead to an increase or decrease in the absolute value of the magnitude of the risk adjustment transfers (and will affect the calculation of the geographic rating area factors). Therefore, an issuer's submission of incorrect EDGE server premium data may have the effect of increasing or decreasing the magnitude of risk adjustment transfers to other issuers in the market, depending on the direction of the premium error, holding constant the other elements of the payment transfer formula. In cases where there is a material impact on risk adjustment transfers for that particular market as a result of incorrect EDGE server premium data, HHS would calculate the dollar value of differences in risk adjustment transfers, and, where the difference is detrimental to one or more issuers in the market, adjust the other issuers' risk adjustment transfer amount by that calculation, and increase the risk adjustment charge (or decrease the risk adjustment payment) to the issuer that made the data error, in order to balance the market.
We are finalizing this policy as proposed.
As noted above, if a State is not approved to operate, or chooses to forgo operating its own risk adjustment program, HHS will operate risk adjustment on its behalf. In 2019, HHS will be operating a risk adjustment program in every State. As described in the 2014 Payment Notice, HHS's operation of risk adjustment on behalf of States is funded through a risk adjustment user fee. Section 153.610(f)(2) provides that an issuer of a risk adjustment covered plan must remit a user fee to HHS equal to the product of its monthly billable member enrollment in the plan and the per member per month risk adjustment user fee specified in the annual HHS notice of benefit and payment parameters for the applicable benefit year.
OMB Circular No. A-25R established Federal policy regarding user fees, and specified that a user charge will be assessed against each identifiable recipient for special benefits derived from Federal activities beyond those received by the general public. The risk adjustment program will provide special benefits as defined in section 6(a)(1)(B) of Circular No. A-25R to issuers of risk adjustment covered plans because it mitigates the financial instability associated with potential adverse risk selection. The risk adjustment program also contributes to consumer confidence in the health insurance industry by helping to stabilize premiums across the individual and small group markets.
In the 2018 Payment Notice, we calculated the Federal administrative expenses of operating the risk adjustment program for the 2018 benefit year to result in a risk adjustment user fee rate of $1.68 per billable member per year or $0.14 PMPM, based on our estimated contract costs for risk adjustment operations and estimates of billable member months for individuals enrolled in a risk adjustment covered plan. For the 2019 benefit year, we proposed to use the same methodology to estimate our administrative expenses to operate the program. These contract costs cover development of the model
We previously estimated that the total cost for HHS to operate the risk adjustment program on behalf of States for 2019 will be approximately $38 million, and the risk adjustment user fee would be $1.68 per billable member per year, or $0.14 PMPM. However, we now estimate the cost for HHS to operate the risk adjustment program on behalf of States for the 2019 benefit year to be approximately $40 million, and are finalizing a risk adjustment user fee of $1.80 per billable member per year, or $0.15 PMPM, to take account of eligible administrative and personnel costs related to the operation of the HHS-operated risk adjustment program that were previously excluded from the estimate.
Since July 18, 2011, issuers have been required to submit rate filing justifications for rate increases for non-grandfathered plans in the individual and small group markets. This requirement was established, in part, to carry out the Secretary's responsibility, in conjunction with States, under section 2794(b)(2)(A) of the PHS Act to monitor premium increases of health insurance coverage offered through an Exchange and outside of an Exchange. Student health insurance coverage is considered by HHS to be a type of individual market coverage and is generally subject to the PHS Act individual market requirements, which has included rate review. We proposed to modify § 154.103(b) to exempt student health insurance coverage from the Federal rate review requirements, effective for plan or policy years beginning on or after January 1, 2019. As we discussed in the proposed rule, and as commenters noted, student health insurance coverage is generally rated and administered differently from other forms of individual health insurance coverage.
States have allowed rating practices for student health insurance coverage to be more in line with large group pricing, in which experience rating and other factors can be used to determine rates. Because student health insurance coverage is typically experience rated, and is typically only available to students and their dependents with an open enrollment period coinciding with the start of the academic year, it is exempt from single risk pool rating requirements and not guaranteed to be available or renewable to individuals who are not students or dependents of students in an institution of higher education. We are finalizing the exemption as proposed, except that we are modifying the applicability date to align with the timing of when student health insurance coverage typically begins, such that the exemption will be effective for student health rate filings for the next plan year. This change, effective for student health insurance coverage effective on or after July 1, 2018, will reduce the regulatory burden on States and issuers of student health insurance plans.
Section 2794(a)(1) of the PHS Act requires the Secretary, in conjunction with States, to establish a process for the annual review of unreasonable premium increases for health insurance coverage. Section 2794(a)(2) of the PHS Act requires health insurance issuers to submit to the Secretary and relevant State a justification for an unreasonable premium increase prior to implementation. States may establish a more robust review process, and many have.
Section 154.200(a)(1) currently provides that a rate increase for single risk pool coverage beginning on or after January 1, 2017 is subject to a reasonableness review if: (1) The average increase, including premium rating factors described in § 147.102, for all enrollees, weighted by premium volume for any plan within the product, meets or exceeds 10 percent; or (2) the increase exceeds a State-specific threshold approved by the Secretary. We proposed to amend this provision to establish a 15 percent default threshold for reasonableness review, in recognition of significant rate increases in the past number of years, rather than the current 10 percent default threshold.
Section 154.200(a)(2) currently requires States to submit a proposal to the Secretary for approval of any State-specific threshold. We proposed to amend § 154.200(a)(2) to require submission of a proposal only if the State-specific threshold is higher than the Federal default threshold. We proposed this change to reduce burden and promote State flexibility.
We also proposed to delete paragraph (b) in its entirety. That paragraph currently requires that the Secretary publish a notice each year indicating which threshold applies to each State. For States that request a State-specific threshold above what is set by CMS, CMS noted it would continue to post information on its website beginning with requests submitted on or after January 1, 2019.
We proposed to redesignate paragraph (c) as paragraph (b) and revise that paragraph to delete the language related
We are finalizing these changes as proposed with one modification, described below. These changes will apply to single risk pool rate filings submitted by issuers for plan or policy years beginning on or after January 1, 2019.
We are not lowering the threshold to 6 percent, as doing so may increase the burden on issuers and States. We are not establishing two thresholds (one at the product level and one at the plan level). When determining whether an increase is subject to review, rate increases are calculated at the plan level. That ensures that a plan that experiences a significant rate increase does not avoid review simply because the average increase for the product did not meet or exceed the applicable threshold. Because consumers are affected by rate increases at the plan level, we believe that increases for the plan, not the product, should continue to be the trigger for determining whether an increase is subject to review.
We expect the change to have a minimal impact on transparency. All issuers must continue to submit a Uniform Rate Review Template (URRT) (Part I of the Rate Filing Justification) for all single risk pool plan submissions. Issuers offering a QHP or any single risk pool submission containing a rate increase of any size must continue to submit an actuarial memorandum (Part III of the Rate Filing Justification). We are finalizing the proposal to change the Federal default review threshold to 15 percent beginning with single risk pool rate filings submitted by issuers for plan or policy years beginning on or after January 1, 2019.
Section 154.215(h)(2) includes a reference to 45 CFR 5.65, which defined trade secret and confidential commercial or financial information under HHS regulations implementing the Freedom of Information Act, 5 U.S.C. 552. HHS revised 45 CFR part 5 in a final rule issued on October 28, 2016, effective on November 28, 2016 (81 FR 74930). We proposed to make a technical correction to § 154.215(h)(2) to refer to 45 CFR 5.31(d) because 45 CFR 5.65 no longer exists and § 5.31(d) now lists the reasons a record may be withheld. We are finalizing the change as proposed.
Section 154.220(b) provides that a health insurance issuer must submit applicable sections of the Rate Filing Justification for all single risk pool coverage in the individual or small group market by the earlier of (1) the date by which the State requires submission of a rate filing; or (2) the date specified in guidance by the Secretary. We have interpreted that section to require submission of all rate filings, for both QHPs and non-QHPs, at a uniform time.
We proposed to modify § 154.301(b)(2), by reducing the advance notification required, so that a State with an Effective Rate Review Program must notify us in writing, no later than 5 business days prior to the date it intends to make any proposed or final rate filing information public if the State will be posting prior to the date specified by the Secretary. We are finalizing this change as proposed.
Section 154.301(b)(3) provides that a State with an Effective Rate Review Program must ensure that information regarding rate increases is made available to the public at a uniform time for all proposed and final rate increases, as applicable, in the relevant market segment and without regard to whether coverage is offered on or off of an Exchange. That provision was codified in order to set a level playing field, to prevent issuers that submit rate filings later from having an advantage over their competitors that submitted rate filings earlier.
We proposed to eliminate the requirement for uniform posting so that States that have an Effective Rate Review Program would have the option to post proposed and final rate filing information on a rolling basis. We are not finalizing this proposal.
In the 2017 Payment Notice, HHS introduced standardized options (also now referred to as Simple Choice plans). A standardized option is a QHP offered for sale through an individual market Exchange that either has a standardized cost-sharing structure specified by HHS in rulemaking or has a standardized cost-sharing structure specified by HHS in rulemaking that is modified only to the extent necessary to align with the high deductible health plan (HDHP) requirements under section 223 of the Code or the applicable annual limitation on cost sharing and HHS actuarial value requirements. For the 2017 and 2018 benefit years, HHS specified standardized options in rulemaking, encouraged issuers to offer such plans, and provided differential display of these plans on
As noted in the proposed rule, we seek to encourage free market principles in the individual market, and to maximize innovation by issuers in designing and offering a wide range of plans to consumers. We noted concerns that providing differential display for these plans may limit enrollment in coverage with plan designs that do not match the standardized options, removing incentives for issuers to offer coverage with innovative plan designs. We believe that encouraging innovation is especially important now, given the stresses faced by the individual market. Therefore, we are finalizing our proposal to not specify any standardized options for the 2019 benefit year, and not to provide differential display for standardized options on
Many other commenters supported HHS continuing to specify standardized options, noting that they are a useful consumer-support tool that aids in plan comparisons and selection and that withdrawing the standardized options could create confusion for consumers, especially those with low health literacy or certain health conditions. Others noted that removing the standardized option designation could make plan selection more difficult resulting in fewer people enrolling in QHPs.
Some commenters noted that the standardized cost sharing encourages issuers to innovate on other plan features and encourages issuers to compete on networks and formularies. Other commenters noted that the standardized plan designs ensure offerings had certain desirable features, such as fewer specialty drug tiers and first dollar coverage. Commenters noted that standardized options were voluntary and therefore could not stifle innovation. Another commenter noted that removing standardized options could result in issuers designing plans specifically for a healthy population. Another commenter supported making standardized options mandatory and expanding to include SADPs.
As we noted in the 2017 Payment Notice final rule,
We agree with commenters that
For these reasons we are finalizing the policy as proposed.
While the PPACA allowed each State to operate its own State Exchange, currently 11 States and the District of Columbia operate their own Exchanges, five States utilize the SBE-FP model, and FFEs operate in the remaining 34 States. We seek to support innovation by States operating State Exchanges by providing opportunities for increased program flexibilities to help support the retention and financial self-sustainability of States that adopted the SBE model. In particular, we sought comment on how HHS can best support State Exchange efforts to utilize commercial platform services, including what type of technical support would be useful and what, if any, specific regulatory changes would facilitate the use of these services.
We also proposed to explore strategies to make the SBE-FP model more appealing and viable to States with FFEs, as well as to support retention of existing SBE-FPs. As codified in the 2017 Payment Notice, the SBE-FP model allows States to establish the legal status of their Exchanges as State Exchanges while leveraging the economies of scale available through the Federal eligibility and enrollment platform and information technology infrastructure. The SBE-FP model offers States opportunities to retain more control over their Exchanges than if an FFE operated in the State, as it allows them to control plan management and consumer assistance activities, without the additional responsibility of building the infrastructure required to operate an information technology eligibility and enrollment platform. Accordingly, we seek to explore options for streamlining current requirements and leveraging private sector and Federal platform
Other commenters supported the concepts of innovation and increased customization of the Federal platform, but suggested HHS prioritize improvements to the overall
Section 155.106 describes the process for a State electing to operate a State Exchange, terminating its State Exchange and transitioning to an FFE, or seeking to operate an SBE-FP. This section applies to both individual market and SHOP Exchanges. Currently, under § 155.106(c), as finalized in the 2017 Payment Notice, States can elect to operate an individual market SBE-FP, an SBE-FP for SHOP, or both. If a State operates an SBE-FP for SHOP, the SBE-FP utilizes the Federal platform for enrollment, eligibility, and premium aggregation functions.
As discussed more fully in section III.D.9 of this final rule, we proposed changes to required SHOP functionality, effective on the effective date of this rule, for plan years beginning on or after January 1, 2018, under which qualified employers and employees could enroll in SHOP plans by working with a QHP issuer or SHOP-registered agent or broker. As a result of the finalization of these proposals, many Federal platform functions currently available to a State operating an SBE-FP for SHOP will no longer exist, including employee eligibility, enrollment, and premium aggregation functions. Therefore, States operating an SBE-FP for SHOP will no longer be able to utilize the Federal platform for those functions.
We proposed to amend § 155.106(c) to remove the option for States to seek approval to operate an SBE-FP for SHOP after the effective date of this rule, and are finalizing the policy as proposed. Nonetheless, States that are currently operating an SBE-FP for SHOP, which include Kentucky and Nevada, can choose to maintain their existing SBE-FPs for SHOP, using the Federal platform functionality that would remain, subject to the applicable requirements in § 155.200(f)(4), which we are amending to align with the changes to SHOP functionality requirements. Issuers in these SBE-FPs for SHOP will continue to be subject to § 156.350, which we are amending to align with the changes to SHOP functionality requirements. For those issuers that offer SHOP QHPs in SBE-FPs for SHOP beginning on or after January 1, 2018, the expected burden (as well as expected reduction in burden) should be similar to that of issuers in the FF-SHOPs.
Section 1311(d)(3)(B) of the PPACA permits a State, at its option, to require QHPs to cover benefits in addition to the EHB, but requires a State to make payments, either to the individual enrollee or to the issuer on behalf of the enrollee, to defray the cost of these additional State-required benefits. In previous rulemaking, we directed States to identify additional State-required benefits that are subject to defrayal and provided direction on how QHP issuers in a State must calculate the cost of those benefits.
We made a number of proposals at § 156.111 related to State changes to EHB-benchmark plans beginning for the 2019 plan year. In light of those proposed changes, we stated that we were not proposing any changes to the policies governing State-required benefits at § 155.170. That is, whether a benefit mandated by State action could be considered EHB would continue to depend on when the State enacted the mandate (unless the benefit mandated was for the purposes of compliance with Federal requirements). Under any of the proposed methods for a State to select a new EHB-benchmark plan, benefits mandated by a State action
As discussed more fully in the preamble for § 156.111, we proposed that § 155.170 would continue to apply in the same manner as it currently applies to § 156.110, and that the proposed § 156.111, which offers States the flexibility to select a new EHB-benchmark plan, would not remove the obligations required with regard to maximum allowed generosity for a State's EHB-benchmark plan. For further discussion of how the State mandate policy at § 155.170 would apply to EHB under the proposals at § 156.111 providing States with options to select a new EHB-benchmark plan for plan years beginning in 2020 and later, see the preamble to § 156.111.
We sought comments on this approach. Specifically, we were interested in comments on different applications of the State mandate policy to the proposed policy for EHB-benchmark plan selections at § 156.111 that would increase State flexibility while also being cost effective for States, consumers, and the Federal government, such as an approach that would allow States the flexibility to update benefits mandated by State action prior to or on December 31, 2011, that are considered EHB, so long as the State can prove that the update to the State mandate is budget neutral.
In this final rule, we are finalizing the approach described above of not making changes to the policy under § 155.170.
Specifically, if a State selects a new EHB-benchmark plan under any of the options finalized in this rule at § 156.111, the benefits mandated by the selecting State's action prior to or on December 31, 2011 will continue to be considered EHB and will not be subject to defrayal, in accordance with § 155.170. If the State is selecting from another State's EHB-benchmark plan under the first or second option, as discussed in preamble to § 156.111, and the selected EHB-benchmark plan (or category of services) includes benefits mandated by the State from which the plan originated that are EHB, those benefits will also be incorporated into the selecting State's EHB-benchmark plan without a requirement that the selecting State defray their related costs, unless the selecting State has its own mandates regarding these same benefits and those mandates meet the requirements for defrayal in § 155.170.
Relatedly, our decision to maintain the policies governing State-required benefits at § 155.170 is motivated by our goal to provide States with more flexibility and reduce administrative burden for selecting a new EHB-benchmark plan under Option 1 or 2 described in § 156.111. Specifically, we believe that many benefits that are State mandates are likely already embedded
We also note that we are finalizing that all options for a State to select a new EHB-benchmark plan described in § 156.111 are limited by a generosity standard. This generosity standard will limit the State's ability to increase the overall scope of benefits in its EHB-benchmark plan beyond the generosity of a set of comparison plans that includes a State's 2017 EHB-benchmark plan and any of the State's base-benchmark plan options for the 2017 plan year described in § 156.100(a)(1), supplemented as necessary under § 156.110. In practice, this requirement limits States' overall ability to select a new EHB-benchmark plan that transfers benefits that were previously only applied to the State's large group market, or that were mandated by other States' actions prior to 2012, into its new EHB-benchmark plan. As a result, we believe that this approach balances our goal to promote State flexibility with the need to preserve coverage affordability. For additional discussion on considerations related to § 155.170 for States that select a new EHB-benchmark plan using an option described at § 156.111, see the preamble to section § 156.111.
The 2017 Payment Notice finalized requirements at § 155.200(f)(2) for SBE-FPs to establish and oversee certain requirements for their QHPs and QHP issuers that are no less strict than the requirements that apply to QHPs and QHP issuers on an FFE. Due to the operational complexities in implementing these requirements from both the State and Federal perspective, and to promote the goal of returning regulatory authority over the insurance markets to States, we proposed to eliminate requirements for SBE-FPs to enforce FFE standards for network adequacy at § 155.200(f)(2)(ii) and essential community providers at § 155.200(f)(2)(iii). Instead, we proposed that the SBE-FPs, like other State Exchanges, would have the flexibility to determine how to implement the network adequacy and essential community provider (ECP) standards with which issuers offering QHPs through the SBE-FP must comply. We believe SBE-FPs are best positioned to determine these standards for the QHP certification process in their States, and that the removal of the requirement that SBE-FPs establish and oversee requirements for their issuers that are no less strict than the manner in which these regulatory requirements are applied to FFE issuers would streamline certain aspects of the QHP certification process, and return traditional insurance market regulatory authority to the States. Additionally, HHS proposed that, for 2019 plan years and later, the FFEs would rely on State reviews of network adequacy standards where the States have been determined to have an adequate review process. Accordingly, we believe similar deference should be granted to States with SBE-FPs. We believe these changes will further empower SBE-FPs to use their QHP certification authority to encourage issuers to stay in the Exchange, enter the Exchange for the first time, or expand into additional service areas. We are finalizing these changes as proposed.
We also proposed to remove the requirement at § 155.200(f)(2)(iv) that QHP issuers in SBE-FPs comply with the Federal meaningful difference standard to reflect the removal of § 156.298 described elsewhere in this rule. We are finalizing this change as proposed.
Section 155.200(f)(4) describes requirements for States that operate an SBE-FP for SHOP. As discussed earlier in this preamble, although we proposed that States can no longer elect to operate SBE-FPs for SHOP after the effective date of this rule, which we are finalizing as proposed, Kentucky and Nevada are already approved to operate SBE-FPs for SHOP, and thus the requirements in § 155.200(f)(4) remain relevant for those SBE-FPs for SHOP. Therefore, we proposed to amend § 155.200(f)(4) to reflect the proposed amendments (described in section III.D.9 of this final rule) under which the functionality of the FF-SHOPs' platform would be reduced for plan years beginning on or after January 1, 2018. Specifically, we proposed to amend the introductory text to § 155.200(f)(4) to describe the requirement applicable, effective on the effective date of this rule for plan years beginning on January 1, 2018 and beyond, and to make the requirements in paragraphs (f)(4)(i) through (vii), effective on the effective date of this rule applicable for only plan years beginning prior to January 1, 2018.
Specifically the requirements in (f)(4)(i) and (iv), which require SBE-FPs for SHOP to align their premium payment and employer contribution calculation methodologies with those used by the Federal platform, would not apply for plan years beginning on or after January 1, 2018, effective on the effective date of this rule. Because under our amendments to § 155.705 and newly finalized § 155.706, for plan years beginning on or after January 1, 2018, the Federal platform for SHOP will no longer calculate premium rates or employer contributions, and will no longer aggregate premium payments (as of the effective date of the final rule),
Because under the approach we are finalizing, the Federal platform will continue to include plan display with premium amounts, we did not propose changes to the requirement that States operating an SBE-FP must require its QHP issuers to make any changes to rates in accordance with the timeline applicable in a Federally-facilitated SHOP under current § 155.705(b)(6)(i)(A), which regulation is mirrored in our proposed introduction of § 155.706(b)(6)(i)(A). However, we proposed to specify that this requirement applies in the introductory text to (f)(4), to reflect the proposed change to make the requirements in (f)(4)(i) through (vii) applicable for only plan years beginning prior to January 1, 2018, effective on the effective date of this rule.
Additionally, because under the approach we are finalizing, for plan years beginning on or after January 1, 2018, the Federal platform will, effective on the effective date of this rule no longer calculate whether a qualified employer has met the applicable minimum participation rate, there will no longer be any need for States operating an SBE-FP for SHOP to align their minimum participation rate requirements and calculation methodologies with those applicable in the FF-SHOPs for plan years beginning on or after January 1, 2018. Therefore, we proposed that this requirement would only apply for plan years beginning prior to January 1, 2018, effective on the effective date of this rule.
To align with our amendments at § 155.725 and newly finalized § 155.726, under which the FF-SHOPs, effective on the effective date of this rule, for plan years beginning on or after January 1, 2018, will no longer establish annual employee open enrollment periods, or establish effective dates of coverage for an initial group enrollment or group renewal, we also proposed that the requirements in § 155.200(f)(4)(v) and (vi) would only apply for plan years beginning prior to January 1, 2018, effective on the effective date of this rule. Finally, to align with our amendments at § 155.735, under which the FF-SHOP, effective on the effective date of this rule for plan years beginning on or after January 1, 2018, will no longer determine the timing, form, and manner in which coverage or enrollment in a SHOP QHP may be terminated, we proposed that the requirement in § 155.200(f)(4)(vii) would only apply for plan years beginning prior to January 1, 2018, effective on the effective date of this rule.
We are finalizing as proposed the changes to § 155.200. Substantive comments related to SHOP proposals are summarized in section III.D.9 of this final rule.
Each Exchange is required under section 1311(d)(4)(K) and 1311(i) of the PPACA to establish a Navigator program under which it awards grants to entities that, among other things: Conduct public education activities to raise awareness of the availability of QHPs, distribute fair and impartial information concerning enrollment in QHPs and the availability of PTCs and CSRs, and facilitate enrollment in QHPs. Under section 1311(i)(2)(B) of the PPACA, these entities may include trade, industry, and professional associations; commercial fishing industry organizations; ranching and farming organizations; community and consumer-focused nonprofit groups; chambers of commerce; unions; resource partners of the Small Business Administration; other licensed insurance agents and brokers; and other entities that meet the statutory requirements at section 1311(i)(3), (4), and (5) of the PPACA.
Currently, § 155.210(c)(2) specifies that each Exchange must include among its Navigator grantees both a community and consumer-focused nonprofit group and at least one other entity that is from one of the other categories listed at § 155.210(c)(2), including other public or private entities or individuals that meet the requirements of § 155.210. Section 155.210(c)(2)(viii) specifies that these other entities may include Indian tribes, tribal organizations, urban Indian organizations, and State or local human service agencies.
To maximize the flexibility and efficiency of the Navigator program, we proposed to amend § 155.210(c)(2) to remove the requirements that each Exchange must have at least two Navigator entities and that one of these entities must be a community and consumer-focused nonprofit group. As discussed further below, we are finalizing this amendment as proposed. We believe removing these requirements will provide Exchanges with improved flexibility to award funding to the number and type of entities that will be most effective for the specific Exchange. We believe that eliminating the requirement to have at least two Navigator entities will allow each Exchange to optimally use the funding amounts available to direct investments to effective and efficient Navigators, which may include selecting a single, high performing grantee in an Exchange.
The requirement that one Navigator grantee in each Exchange must be a community and consumer-focused nonprofit group may unnecessarily limit an Exchange's ability to award grants to the strongest applicants, particularly in an Exchange that opts under this final rule to have only one Navigator grantee and where the strongest applicant is not a community and consumer-focused nonprofit group. Keeping this requirement would effectively exclude any other type of statutorily eligible entities from becoming Navigators in an Exchange that opts to have only one Navigator grantee. Eliminating this requirement will provide Exchanges with the flexibility to target grants to the highest scoring and performing entities, regardless of organization type.
Removing these requirements at § 155.210(c)(2) will also promote Exchange flexibility and autonomy to structure Navigator programs tailored to each Exchange. An Exchange could award a grant to a single Navigator entity from any of the permitted types. Alternatively, Exchanges could elect to continue awarding two or more grants, as they have been doing thus far, and include a community and consumer-focused nonprofit group among those grantees.
Section 155.210(e)(7) requires each Navigator entity to maintain a physical presence in the Exchange service area, so that face-to-face assistance can be provided to applicants and enrollees. We proposed to remove this requirement to provide more flexibility to each Exchange to structure its Navigator program to best serve the Exchange service area, and as discussed further below, are finalizing this amendment as proposed. Under section 1311(i)(2)(A) of the PPACA and § 155.210(c)(1)(ii), entities seeking to become Navigator grantees must demonstrate to the Exchange that they have existing relationships, or could readily establish relationships, with employers and employees, consumers (including uninsured and underinsured consumers), or self-employed individuals likely to be eligible for enrollment in a QHP. Consistent with those provisions, Navigator grant applicants in the FFEs are scored on their ability to make this demonstration. Based on HHS's experience with Navigator programs in FFEs and other public programs, we believe entities with strong relationships in their FFE service areas tend to deliver the most effective outreach and enrollment
For reasons similar to those motivating our proposed changes to § 155.210(e)(7), as well as to promote consistency across programs, we proposed to remove the corresponding requirement at § 155.215(h) that requires maintenance of a physical presence in the Exchange service area by all non-Navigator entities subject to § 155.215. We are also finalizing this amendment as proposed.
In addition to the requirement to maintain a physical presence in the Exchange service area, §§ 155.210(e)(7) and 155.215(h) currently provide that, in an FFE, no individual or entity is ineligible to operate as a Navigator or non-Navigator assistance personnel solely because its principal place of business is outside of the Exchange service area. We did not propose to amend or remove that language, and it will remain in effect.
In addition to seeking comment on the proposed amendments described above, we also sought comment on statutorily acceptable alternative types of entities that could serve as Navigators and on possible new ways in which Navigators could carry out their duties.
For a discussion of the provisions of this final rule related to standards applicable to non-Navigator Assistance Personnel subject to § 155.215, please see the preamble to § 155.210.
HHS proposed new standards in the proposed rule to replace the standards set forth in the 2018 Payment Notice for § 155.221 for third-party onboarding operational readiness reviews and audits for direct enrollment partners. HHS also proposed to expand the applicability of this section to require issuers, in addition to agents and brokers, participating in direct enrollment to engage third-party entities to conduct the required operational readiness reviews. We proposed a conforming edit to § 156.1230(b)(2) to reflect this proposal.
HHS proposed to implement an approach wherein agents, brokers, and issuers that participate in direct enrollment and use their own internet website for QHP selection or to complete the Exchange eligibility application would select their own third-party entities for conducting audits, rather than requiring HHS to initially review and approve these entities. As detailed in the proposed rule, HHS anticipates this approach would reduce the regulatory burden for agents, brokers, and issuers, and reduce duplicative HHS oversight. This approach will also reduce the burden on third-party entity reviewers.
Beginning with the open enrollment period for the 2019 benefit year, we proposed that an agent, broker, or issuer must engage a third-party entity that meets the standards outlined in the new § 155.221(b) to conduct an annual operational readiness review prior to participating in direct enrollment. Consistent with § 155.220(c)(3)(i)(K) and § 156.1230(b)(2), the operational readiness review would be performed using the third parties' own audit processes and methods subject to HHS-defined specifications and requirements. The third-party entity's review would verify compliance by the agent, broker, or issuer with the applicable requirements in §§ 155.220, 155.260, 156.265, and 156.1230, and would need to be completed prior to the use of the agent, broker, or issuer internet website for submission of an Exchange application or completion of QHP selection. HHS would publish technical guidance outlining the review standards and other operational details, as well as provide other resources to assist the third-party entities in conducting the reviews at a later date. As outlined in the last sentence of the new § 155.221(a), the third-party entity would be a downstream or delegated entity of the agent, broker, or issuer that participates or wishes to participate in direct enrollment. Therefore, these third-party entities would be subject to HHS oversight as delegated or downstream entities of an agent, broker, or issuer, and the agent, broker, or issuer will remain responsible for compliance with all applicable direct enrollment requirements.
We also proposed revisions to § 155.221(b), which establishes standards that third-party entities must satisfy to perform the reviews to demonstrate operational readiness under § 155.220(c)(3)(i)(K) and § 156.1230(b)(2), beginning with the open enrollment period for the 2019 benefit year. The proposed new introductory language at § 155.221(b) aligns with the new approach where the agent, broker, or issuer selects the third-party entity to perform the audit under paragraph (a). As proposed, new § 155.221(b)(1) would require the entity to have experience conducting audits or similar services, including specific experience with relevant privacy and security standards due to the operational requirements of the current direct enrollment processes and any potential future enhancements. This would include demonstrated experience with current National Institute of Standards and Technology (NIST) SP 800-53 or the HIPAA Security Rule standards, and the review of compliance with those standards. We proposed that auditors must also be capable of performing penetration testing on all interfaces that collect personally identifiable information or connect with HHS. We proposed to modify § 155.221(b)(2) to include issuers participating in direct enrollment and to expand the scope of the audit to also include review of compliance with other applicable program requirements (for example, website design, or consumer disclosures). Under proposed § 155.221(b)(3), auditors would be required to collect, store, and share with HHS all data related to its audits of
The proposed revisions to paragraph (b)(4) would implement a conflict of interest standard that requires disclosure of financial relationships between a third-party entity conducting a direct enrollment operational readiness review and the agent, broker, or issuer. In addition, the third-party entity would be required, under § 155.221(b)(5), to comply with all applicable Federal and State requirements; under § 155.221(b)(6), to ensure, on an annual basis, that appropriate staff successfully complete operational readiness review training as established by HHS prior to conducting audits under paragraph (a) of this section; and, under § 155.221(b)(7), to permit access by the Secretary and the Office of the Inspector General (OIG), or their designees, in connection with their right to evaluate through audit, inspection, or other means, to the third-party entity's books, contracts, computers, or other electronic systems, relating to the third-party entity's audits of agents, broker's, or issuer's obligations in accordance with Federal standards under paragraph (a) of this section until 10 years from the date of creation. Finally, to provide flexibility, under § 155.221(c) an agent, broker, or issuer would be permitted to engage multiple third-party entities to perform the audits under paragraph (a) and each such third-party entity would need to separately comply with the standards under paragraph (b). We are finalizing these amendments as proposed, with a minor, non-substantive change described below.
Section 155.305(f)(4)(i) prohibits an Exchange from determining a consumer eligible for APTC if APTC payments were made on behalf of the tax filer for the consumer's household (or either spouse, if the tax filer is married) for a previous year for which tax data would be used for verification of household income and family size, and the tax filer or his or her spouse did not comply with the requirement to file an income tax return and reconcile APTC paid on their behalf that year. Under the current regulation at paragraph (f)(4)(ii), Exchanges cannot discontinue APTC due to a failure to file and reconcile (FTR) associated APTC unless direct notification is first sent to the tax filer that his or her eligibility will be discontinued as a result of the tax filer's failure to comply with the requirement specified under paragraph (f)(4)(i) of § 155.305.
We proposed to amend § 155.305(f)(4) by removing the direct notification requirement in paragraph (f)(4)(ii) and revising the remaining paragraph (f)(4) to move the content in paragraph (f)(4)(i) into paragraph (f)(4).
We are finalizing this policy as proposed.
To avoid unauthorized disclosure of FTI to individuals who are not the relevant tax filer, the FFE sends notices to FTR and non-FTR consumers that contain language regarding FTR, but also language that is broad enough to apply to all consumers who receive them; these notices are referred to as “combined notices.” For example, the FFE sends the same Marketplace Open Enrollment Notice to three groups of consumers at risk for APTC discontinuation in the upcoming coverage year: Those flagged as FTR, those for whom the FFE has received updated income information that suggests the consumers may have income too high to qualify for APTC, and those who did not permit the Exchange to check IRS data. Because the combined notices apply and are sent to some consumers who are currently unaffected by FTR, and not exclusively to individuals who are affected by FTR, these notices are not considered FTI under IRS rules and are able to be sent using the standard FFE notice functionality.
To supplement the combined notice, in November 2017, the FFE also mailed warning notices that complied with FTI rules to tax filers on whose behalf APTC was being paid but for whom the FFE had information the tax filer had not met the requirement to file and reconcile. These notices, which we refer to as “direct notices,” urged the tax filers to file and reconcile to avoid losing APTC starting in January 2018. To comply with FTI requirements, the direct notices were not generated by the FFE itself; rather, data was securely sent to an FTI-compliant print contractor for printing and mailing. In order to be FTI-compliant—including being accessible only to the tax filer—direct notices are not available through the online Exchange account for the application.
We intend for the FFE to continue sending two notices in advance of open enrollment where the Exchange has information that the tax filer on whose behalf APTC is being paid has failed to meet the requirement to file and reconcile: (1) A combined notice provided according to the communication preference set for the household contact (electronic or via U.S. mail) that will be available in consumers' online accounts and to the Exchange call center; and (2) a direct notice sent via U.S. mail to the tax filer that is not available electronically in the household's online account or to the Exchange call center, in order to protect FTI. The direct notice serves to unambiguously explain that the tax filer has been identified as having failed to meet the requirement to file and reconcile and must come into compliance to avoid termination of APTC. In 2018, the FFE will also send a combined notice and a direct notice in connection with its periodic check of tax data described in § 155.330(e)(2)(iii)(B). As commenters noted, we believe sending more than one notice may increase the likelihood that consumers identify and read the notices and ultimately take action.
We agree with commenters that it is important for all Exchanges to protect consumers' due process rights. Even in the case of an Exchange that cannot arrange to send direct notices that explicitly address FTR to the tax filer and that is limited to the combined notice approach, we believe there are adequate protections for due process. First, the tax filer still has an opportunity before the Exchange redetermines eligibility to file a tax return (or an amended tax return, as applicable) and reconcile APTC paid for the relevant benefit and tax year. We expect Exchanges to send appropriate notices to households affected by FTR that alert the tax filer that FTR may be the reason enrollees' eligibility for APTC is at risk. Second, for enrollees whose eligibility for APTC is terminated as a result of FTR, the enrollee will receive an updated eligibility determination notice that contains a full explanation of appeal rights. Enrollees who appeal may request to continue receiving financial assistance during the appeal, consistent with § 155.525. We believe these measures, including the option to maintain eligibility during an appeal, are consistent with due process.
One SBE supported the proposal to remove the direct notification provision in § 155.305(f)(4)(ii), citing significant implementation challenges to communicate with consumers without violating IRS's FTI security protections. It stated that current FTR processes and notifications being implemented by most Exchanges provide adequate notice to consumers.
When consumers submit an FFE application, the filer of the application must agree to a statement that he or she has obtained consent for all people listed on the application for their information to be used for eligibility determination purposes, including verifying this information using the Exchange's trusted electronic data sources. In addition, following application submission and when selecting a plan and choosing the amount of APTC to apply to the monthly premium, the tax filer is required to agree to a statement that he or she must file a tax return for the year during which APTC is paid on his or her behalf (or on behalf of his or her spouse) and to reconcile those payments with IRS. The filer of the application specifies the contact person for Exchange communications (the household contact), as well as the method of communication they prefer—either electronic or via U.S. mail to the address they enter on the application. Because this household contact is designated as the point of contact for the enrollee(s) on the application, we
We are finalizing these provisions as proposed, but remain committed to improving the clarity and effectiveness of the FTR notification process in circumstances where the Exchange has information that the tax filer has failed to file and reconcile.
Section § 155.320(c)(3)(iii) sets forth the verification process for increases in household income. Generally, if income data from our electronic data sources indicate a tax filer's attested projected annual income is
We proposed to revise § 155.320(c)(3)(iii) to specify that the Exchange will generate annual income inconsistencies in certain circumstances when a tax filer's attested projected annual income is
However, where electronic data sources reflect income under 100 percent FPL and a consumer attests to income between 100 percent FPL and 400 percent FPL, where the attested income exceeds the income reflected in trusted data sources by more than some reasonable threshold, we believe it would be reasonable to request additional documentation to protect against overpayment of APTC, since the consumer's attested income could make him or her eligible for APTC that would not be available using income data from electronic data sources. Accordingly, we proposed to add new paragraphs (c)(3)(iii)(D) and (E), and to modify paragraphs (c)(3)(vi)(C), (D), (F), and (G), to specify that the Exchange will follow the procedures in § 155.315(f)(1) through (4) to create an annual income data matching issue for consumers if: (1) The consumer attested to projected annual income between 100 percent and 400 percent of the FPL; (2) the Exchange has data from IRS and SSA that indicates income is below 100 percent FPL; (3) the Exchange has not assessed or determined the consumer to have income within the Medicaid or CHIP eligibility standard; and (4) the consumer's attested projected annual income exceeds the income reflected in the data available from electronic data sources by a reasonable threshold established by the Exchange and approved by HHS. We proposed that a reasonable threshold must not be less than 10 percent, and can also include a threshold dollar amount. In accordance with the existing process in § 155.315(f)(1) through (4), if the applicant fails to provide documentation verifying their income attestation, the Exchange would redetermine the applicant's eligibility for APTC and CSRs based on available IRS and SSA data, which under this proposal would typically result in discontinuing APTC and CSR as required in paragraph (c)(3)(vi)(G). The adjustment and notification process would work in a manner consistent with other inconsistency adjustments laid out in paragraph (c)(3)(vi)(F).
We proposed to allow the Exchange to set the threshold for setting a data matching issue similar to § 155.320(c)(3)(vi). We proposed that a reasonable threshold should take into account that consumers with incomes near 100 percent FPL have a smaller margin for error in dollar terms. Therefore, a reasonable threshold might also include a fixed dollar amount in addition to a percentage threshold.
We are finalizing this policy as proposed, with two changes. First, after considering the intended purpose of this new program integrity measure, we have decided to add additional regulatory language to § 155.320(c)(3)(iii)(D) that exempts from this additional verification check non-citizen applicants who are lawfully present and ineligible for Medicaid by reason of immigration status.
At § 155.320(c)(3)(vi)(D), we proposed to make changes to provide consistency with changes finalized in the 2017 Payment Notice regarding the threshold for the generation of annual income data matching issues for decreases in annual household income. This proposed change would specify that the 10 percent threshold standard no longer applies to cases when a tax filer's attested projected income is less than all data sources, or when no electronic data sources are available. Instead, an Exchange would use the reasonable threshold established in accordance with § 155.320(c)(3)(vi). We are finalizing this change as proposed.
In the proposed rule, we also noted our interest in providing further guidance on the appropriate thresholds for the generation of data matching issues generally. We intend to reconsider and provide further guidance
We intend to address this issue as part of broader rulemaking and guidance on a number of related program integrity issues, including further examination of our processes for denying eligibility for subsidies for individuals who have failed to reconcile APTC on their Federal income tax return, Exchange processes for matching enrollment data with Medicare and Medicaid in order to address consumers who may be enrolled in duplicative coverage, and our rules around recalculation of eligibility for APTC following a mid-year change in eligibility. In anticipation of these actions, we sought comment generally on these and other program integrity topics.
We are finalizing the changes as proposed.
An employee, or a member of the employee's family, who is eligible to enroll in qualifying coverage in an eligible employer-sponsored plan is not eligible for the PTC unless the plan's coverage for the employee is either unaffordable, as defined in section 36B(c)(2)(C)(i)(II) of the Code, or does not provide minimum value, as defined in section 36B(c)(2)(C)(ii) of the Code. An employee (or member of the employee's family) also is not eligible if he or she actually enrolls in the employer-sponsored plan, even if the plan is not affordable or fails to provide minimum value.
When an individual submits a request for an eligibility determination for insurance affordability programs, including as part of the eligibility verification process for APTC and CSRs, § 155.320(d) requires the Exchange to verify whether the applicant reasonably expects to be enrolled in an eligible employer-sponsored plan or is eligible for qualifying coverage in an eligible employer-sponsored plan for the benefit year for which coverage is requested. Paragraph (d)(2) of § 155.320 describes the data sources an Exchange must use to perform verification. Paragraph (d)(2)(i) requires an Exchange to obtain data from any electronic data sources that are available to the Exchange and which have been approved by HHS based on evidence showing that such data sources are sufficiently current, accurate, and minimize administrative burden. Paragraph (d)(2)(ii) requires that the Exchange also obtain available data based on Federal employment through HHS, and paragraph (d)(2)(iii) requires the Exchange to obtain available data from the SHOP that corresponds to the State in which the Exchange is operating. Under § 155.320(d)(4), if an Exchange is unable to fulfill the requirement to connect to the data sources set forth in (d)(2), the Exchange is required to conduct sampling as described under paragraph (d)(4)(i), or—for benefit years 2016 and 2017—it may conduct an HHS-approved alternative process instead of sampling, as provided under paragraph (d)(4)(ii).
We proposed to amend § 155.320(d)(4) to allow an Exchange to conduct an HHS-approved alternative process instead of sampling, as provided under paragraph (d)(4)(ii), for benefit years through 2019. When we introduced this option for benefit years 2016 and 2017, we received comments that encouraged us to make this option permanent. However, at the time we stated that we believed the alternative process should be used as an interim measure to gather information about the verification process as Exchanges improve their long-term verification programs.
After the option to use an alternate process for benefit years 2016 or 2017 was finalized, HHS investigated the feasibility of connecting to a comprehensive database of information on employer-sponsored coverage that could be used by all Exchanges to fulfill verification requirements under § 155.320(d)(2)(i). Such a database would be most useful and cost-effective if it contained information on employer-sponsored coverage from as many non-Federal and non-SHOP employers as possible. We found that a comprehensive database does not currently exist and building such a database would be a resource-intensive endeavor. In addition, employers are not required to provide information to Exchanges or HHS regarding the coverage they offer, potentially limiting the completeness of such a database.
Because of the current challenges associated with building an HHS-approved database that is sufficiently complete and accurate to satisfy requirements under paragraph (d)(2)(i), we stated we anticipate many Exchanges will fulfill verification requirements using an alternate process, as described under paragraph (d)(4). In recognition of the challenges that Exchanges may encounter with conducting sampling, as explained below, we proposed to extend the option for Exchanges to conduct an alternative process to sampling through benefit year 2019. Our hope is that Exchanges can continue to compile databases sufficient to meet verification requirements under paragraph (d)(2) and to continue to refine their approaches to sampling to meet verification requirements under paragraph (d)(4)(i).
In accordance with the requirement at paragraph (d)(4) to pursue an alternate process, the FFE conducted a pilot study that incorporated many components of sampling. The pilot was intended to assess sampling's value protecting the integrity of the attestation process regarding applicant access to and enrollment in employer-sponsored coverage. As part of this sampling pilot, employers for a small sample of enrollees receiving APTC through the FFEs were contacted by telephone, based on the employer contact information applicants provided on their Exchange applications, and asked whether specified employees were also enrolled in a qualifying employer-sponsored plan or were offered qualifying coverage in an employer-sponsored plan. Since the FFE does not have access to relevant data from employers across the 38 States for which the FFE operates Exchanges, this effort provided an attempt to collect information on each sampled employee by contacting employers' human resources personnel. The FFE found that this approach was not a cost-effective way for the FFE to fulfill verification requirements using an alternate process.
We acknowledged that sampling may be a more cost-effective option for SBEs compared to FFEs. For example, the FFE operates Exchanges for 38 States, and the volume of employers that the FFE encompasses may inherently present challenges in relying on sampling results that States may not face. Some States may collect and have access to data from employers that make verifying consumers' attestations more efficient and reliable, or may have existing channels through which they can communicate with in-State employers. Therefore, we proposed to maintain the option to use sampling as an alternate method of verification under paragraph (d)(4) to allow SBEs maximum
We noted that to the extent an Exchange believes an alternate process to verification through data sources or methods other than those described under paragraph (d) may result in a more efficient or comprehensive verification procedure, the Exchange may also, in accordance with §§ 155.315(h) and 155.320(a)(2), request HHS approval for use of an alternate process for verifying enrollment in and access to employer-sponsored coverage. We noted that HHS received support for providing flexibility for the use of alternate data sources by Exchanges in comments to the Request for Information. For example, we received comments indicating that, for some Exchanges, due to the limited number of Federal employees in their State, connecting to the database containing data on Federal employment provides little utility in Exchange verification of applicants' eligibility for employer-sponsored coverage. One commenter encouraged HHS to consider removing the regulatory requirement to connect to this database for purposes of employer-sponsored coverage verification. We have also received feedback from some Exchanges noting challenges and limitations connecting to a SHOP database. These Exchanges noted that, given the limited enrollment in SHOP in many States and that many States do not have a SHOP database with which to connect, requiring verification through SHOP imposes a technical and financial challenge for States that may not be the most efficient and cost-effective way to perform verification.
Additionally, we sought information and suggestions on ways to improve verification of whether an applicant reasonably expects to be enrolled in an eligible employer-sponsored plan or is eligible for qualifying coverage in an eligible employer-sponsored plan for the benefit year for which coverage is requested.
We are finalizing this policy as proposed.
We sought comment on ways to better encourage enrollees to report changes in circumstance occurring during the benefit year that may affect their eligibility for Exchange coverage or for APTC or CSRs. The FFEs currently conduct proactive outreach to enrollees through a variety of means, including emails, phone calls, and paper mail, to encourage them to return to the Exchange to update their information throughout the benefit year and during key Exchange operational efforts, such as open enrollment. The FFEs also periodically provide general information and reminders to enrollees. However, many changes in circumstance, such as changes in household income or size, remain unknown by the Exchanges until reported by the enrollee.
We are interested in hearing from stakeholders about ways to increase enrollee reporting of individual changes in circumstance within 30 days of the change in order to ensure compliance with § 155.330(b). Increasing such reporting would benefit enrollees by ensuring that they continue to be enrolled based on their current eligibility for financial assistance, and would improve program integrity.
Commenters recommended increasing Exchange outreach efforts, through mail, email, and social media networks, to periodically remind consumers to report any life changes that may have occurred. One commenter recommended that Exchanges use more distinct envelopes when an enrollee action is required to improve the rate at
Commenters recommended that Exchanges make it easier for enrollees to report changes in circumstance online. One State Exchange stated they have information about reporting changes in circumstance on the main page of their Exchange website outside of open enrollment, and that enrollees are asked about whether they need to report a change either over the phone if they call the Exchange call center, or online upon logging into their Exchange accounts.
We are considering the possibility of amending the length of time that individuals may authorize the Exchanges to obtain the updated tax return information for enrollees as described in § 155.335(k)(2). Currently, the Exchanges may obtain updated tax return information for a period of no more than 5 years based on a single authorization.
We sought comment on whether 5 years is an appropriate duration for this type of an authorization, or whether a shorter time period should be considered. In particular, we are contemplating whether shortening this authorization period would improve Exchange program integrity by helping to ensure that the enrollee's application at the time of re-enrollment accurately reflects his or her data collection preferences, that all sources of income that may affect his or her eligibility for APTC and cost-sharing reductions are listed on the application, and that individuals update their applications on a more regular basis to reflect other changes in circumstances that affect eligibility (such as changes in employment or marital status).
For many special enrollment periods, a dependent of an Exchange enrollee may newly enroll in Exchange coverage or switch Exchange plans when the dependent or another qualified individual on the Exchange application qualifies for a special enrollment period. Even though dependents may access special enrollment periods based on different qualifying events, when they qualify for a special enrollment period to newly enroll in Exchange coverage, regardless of whether it is a special enrollment period due to gaining or becoming a dependent or due to a loss of minimum essential coverage, we believe that they should be treated alike. Section 155.420(a)(4) defines the coverage changes Exchange enrollees may make when they or their dependents qualify for special enrollment periods. We proposed to modify how paragraph (a)(4)(iii) treats dependents to align more closely with paragraph (a)(4)(i) which addresses when an existing enrollee gains a new dependent. To do this, we proposed to modify paragraph (a)(4)(iii) to establish a distinction between how the rule treats existing enrollees who qualify for one of the relevant special enrollment periods themselves or when existing Exchange enrollees themselves and their dependent(s) qualify for one of the relevant special enrollment periods; and when only new dependents qualify for one of the relevant special enrollment periods and are enrolling in coverage with an existing Exchange enrollee. We proposed to establish this distinction by separating these situations into new paragraphs (a)(4)(iii)(A) and (a)(4)(iii)(B). We believe the latter situation is akin to when an enrollee adds a new dependent to their coverage, even though in this situation the dependent is qualifying for a different special enrollment period.
Proposed new paragraph (a)(4)(iii)(A) would address the coverage options available to current enrollees and dependents who qualify for a special enrollment period. As is current policy under paragraph (a)(4)(iii), paragraph (a)(4)(iii)(A) would continue to allow enrollees and their dependents who qualify for the special enrollment periods specified in paragraphs (d), other than those described in paragraphs (d)(2)(i), (d)(4), (d)(6)(i) or (ii) for becoming newly eligible for CSRs, (d)(8), (d)(9), and (d)(10) of this section, to use their special enrollment period to change to another QHP within the same level of coverage or one metal level higher or lower, if no such QHP is available, as outlined in § 156.140(b) of this subchapter.
Proposed new paragraph (a)(4)(iii)(B) would address the coverage options available when only a dependent who is not currently enrolled in Exchange coverage qualifies for a special enrollment period. We proposed to revise the policy for these qualified individuals to align with paragraph (a)(4)(i) of this section. We proposed that, if a new dependent qualifies for one of the special enrollment periods specified in paragraphs (d)(1), (d)(3), (d)(6)(iii), (d)(6)(iv), (d)(7), (d)(11), and (d)(13) of this section and an enrollee would like to add the dependent to his or her QHP at that time, the Exchange must allow the enrollee to add the dependent to his or her current QHP; or, if the plan's business rules do not allow the dependent to enroll, the Exchange must allow the enrollee and dependent to change to another QHP within the same level of coverage; or, if no such QHP is available, allow them to switch to a QHP one metal level lower or higher, as outlined in § 156.140(b) of this subchapter. Alternatively, the enrollee may enroll the dependent in a separate QHP at any metal level.
We believe that these modifications are needed in order to align the flexibilities available to enrollees and dependents when a dependent is newly enrolling in Exchange coverage during the benefit year due to qualifying for a special enrollment period. With this proposed change, regardless of the special enrollment period for which a dependent qualifies, an enrollee may either add the dependent to his or her existing QHP, as long as he or she continues to qualify for it, or enroll the new dependent in a separate QHP at any metal level.
In the event that both the enrollee and the new dependent qualify for special enrollment periods referenced in proposed paragraphs (a)(4)(iii)(A) and (a)(4)(iii)(B), respectively, and the enrollee wants to add this new dependent to his or her QHP, the Exchange would allow both the enrollee and dependent to switch to a new QHP at the same metal level, if available, as described in proposed paragraph (a)(4)(iii)(A).
We are finalizing this policy as proposed.
A few commenters supported this proposal, but also requested that changes to the plan option restrictions in paragraph (a)(4) be amended to give affected enrollees and dependents the option to enroll in a QHP at a lower level of coverage, alongside the option to enroll in either the same QHP or another QHP at the same level of coverage, as applicable. Commenters stated that this increased flexibility is especially necessary for situations where enrollees are gaining or become a new dependent, in accordance with paragraph (d)(2)(i) of this section, because changes in household composition, especially the addition of a new infant or child to a household, likely change a household's health care needs and what level of coverage is best suited to meet those needs. Other special enrollment periods included in paragraph (a)(4)(iii)(B), such as the special enrollment periods for loss of minimum essential coverage in paragraph (d)(1) of this section and for being determined ineligible for Medicaid or the Children's Health Insurance Program, may similarly change a household's health care needs if, for example, dependents had been previously enrolled in Medicaid or CHIP and are losing that coverage for the first time.
Several commenters expressed concern about the technical impact the proposed changes would have on State Exchanges, especially those States that had already been working toward implementing the plan option restrictions as finalized in the 2017 Market Stabilization Rule. States cautioned that finalizing this proposal would delay their ability to implement this policy and several States requested State flexibility with respect to this proposal.
Other commenters expressed opposition to this proposed change because it would further restrict plan options available to enrollees and dependents newly enrolling in QHP coverage. These commenters stated that imposing restrictions of individuals' choice of QHPs to enroll in after he or she qualifies for a special enrollment period contradicts the intent of special enrollment periods. One commenter stated that limiting plan options for enrollees or dependents upon qualifying for a special enrollment period is prohibited by the guaranteed issue provision of the PPACA statute. The guaranteed issue provision requires that issuers accept every individual in the State who applies for such coverage and, while issuers may restrict enrollment periods, they stated, restrictions on the type of plan the individual enrolls in is not permitted.
We understand that the proposed changes may delay State Exchanges' ability to implement the plan option restrictions, especially in those States where this proposal will require a change to Exchange system functionality, and, therefore, we believe it is appropriate for States to take additional time, as needed, in order to comply with this change.
Lastly, as we noted in the 2017 Market Stabilization Rule, we considered the concerns regarding conflicts of this policy with the statute, but believe that limiting enrollees' ability to change QHPs or metal levels is consistent with the requirements in section 1311(c)(6)(C) of the PPACA directing the Secretary to require Exchanges to establish special enrollment periods as specified in section 9801 of the Code and under circumstances similar to such periods under Part D of title XVIII of the Act, as well as the Secretary's authority under section 2702(b)(3) of the PHS Act to promulgate regulations for the individual market with respect to special enrollment periods for qualifying events under section 603 of the Employee Retirement Income Security Act of 1974. Given that the PPACA itself called for one annual open enrollment period and additional enrollment opportunities only in the case of special circumstances, we believe it is reasonable to interpret the special enrollment period and guaranteed issue provisions of the PPACA in this manner.
We proposed to exclude the special enrollment period in paragraph (d)(12) for material plan or benefit display errors from paragraph (a)(4)(iii). This is because we understand that certain material plan or benefit display errors may impact an enrollees' decision to enroll in a level of coverage, in addition to his or her decision to enroll in a specific QHP. Therefore, we believe that, if an enrollee qualifies for the special enrollment period because of a material plan or benefit display error, he or she should be allowed to switch to a different QHP at any metal level that better meets his or her needs.
We are finalizing the policy as proposed.
HHS recently added a prior coverage requirement to the special enrollment period for gaining access to new QHPs as a result of a permanent move, described in § 155.420(d)(7), and the special enrollment period for gaining or becoming a dependent through marriage, described in § 155.420(d)(2)(i). Section 155.420(a)(5) specifies how a qualified individual can satisfy the prior coverage requirement. Qualified individuals can demonstrate that they had minimum essential coverage as described in 26 CFR 1.5000A-1(b) for 1 or more days during the 60 days preceding the date of the qualifying event; lived in a foreign country or in a United States territory for 1 or more days during the 60 days preceding the date of the qualifying event; or are an Indian, as defined by section 4 of the Indian Health Care Improvement Act. This prior coverage requirement encourages individuals to maintain coverage throughout the year.
However, we recognize that individuals living in a service area where no Exchange QHPs are offered may not be able to obtain affordable coverage. We believe that individuals in this situation should not later be prevented from enrolling in coverage through a special enrollment period that requires prior coverage when they were previously unable to enroll in Exchange coverage because it was unavailable or inaccessible. Therefore, we proposed to amend paragraph (a)(5) to exempt qualified individuals from the prior coverage requirement if, for at least 1 of the 60 days prior to the date of their qualifying event, they lived in a service area where there were no QHPs offered through an Exchange. Absent this change, qualified individuals who have lived for part of the benefit year in a location where no QHPs were offered through an Exchange, and, therefore, may have been unable to enroll in minimum essential coverage, would be prevented from subsequently qualifying for a special enrollment period due to a permanent move or marriage.
Additionally, we noted that the proposed amendment to paragraph (a)(5) would apply, along with the rest of the paragraph, to the individual market outside of the Exchange through the cross-reference to § 155.420(d) in § 147.104(b)(2). In this context, health insurance issuers offering coverage outside an Exchange would not be able to require qualified individuals to demonstrate prior coverage if they lived for at least 1 of the 60 days prior to their qualifying event in a service area where there were no QHPs offered through an Exchange.
We are finalizing the policy as proposed, except that we are amending the regulatory text to ensure the exception applies to individuals who lived in a service area where no QHPs were offered through an Exchange during their most recent Exchange enrollment period, regardless of whether that enrollment period was an Exchange open enrollment period or a special enrollment period. This change will address situations where no QHPs were available to an individual during their enrollment window, but later became available in the individual's service area prior to his or her marriage or move.
One commenter raised the concern that our proposed criteria for the exception, in particular that a person only have lived for 1 of the 60 days prior to their qualifying event in a service area where there were no QHPs offered through an Exchange, was not stringent enough. This commenter suggested that such a brief residency requirement could lead individuals to move to an affected service area on a transitional basis in order to avoid the prior coverage requirement. To reduce the likelihood that individuals who did not qualify would be able to take advantage of this exception, the commenter recommended that we require individuals to have been residents in a service area without QHPs for the entire 60 day period prior to their qualifying event.
We understand concerns that individuals may seek to fraudulently claim this exception in order to avoid the prior coverage requirement, and we remain committed to promoting continuity of coverage and ensuring that only eligible consumers may access coverage through special enrollment periods. However, we believe that this exception for individuals who have lived in a service area where no QHPs are offered by the Exchange for at least 1 of the 60 days before a qualifying event or during their most recent preceding enrollment period is important, because it takes into account the potential for a service area to temporarily be without a QHP, such as in the case of a temporary QHP suppression or mid-year QHP decertification, and the need to protect individuals who may be affected by this lack of availability. Additionally, we note the need to ensure that individuals are not prevented from accessing coverage through a special enrollment period mid-year because of having lived in a service area where no QHPs were offered through the Exchange during their most recent enrollment period (open enrollment or special enrollment period) when they could have otherwise enrolled in affordable coverage, even if during the 60 days before a subsequent qualifying event a QHP is available in their service area. Therefore, we are finalizing this exception to the prior coverage requirement that currently applies to certain special enrollment periods to include consumers who lived
We also note that concerns that individuals will fraudulently claim eligibility for an exception to the prior coverage requirement are addressed in part because the FFE will continue to require document-based verification of the individual's eligibility for the special enrollment period and, in order to qualify for the special enrollment period due to a permanent move, individuals will continue to be required to meet the residency requirements for their new and former addresses, in accordance with § 155.305(a)(3) and as explained in the January 2016
Paragraph (b)(2)(i) of § 155.420 requires Exchanges to provide individuals who qualify for a special enrollment period due to gaining or becoming a dependent through birth, adoption, placement for adoption, or placement in foster care, as described in paragraph (d)(2)(i), with a retroactive coverage effective date back to the date of the qualifying event. It also gives Exchanges the option to allow these consumers to elect an effective date of the first of the month following the date of the event or following regular coverage effective dates, in accordance with paragraph (b)(1) of this section. Paragraph (b)(2)(v) addresses coverage effective date options for special enrollment periods related to gaining or becoming a dependent due to a child support or other court order, as also described in paragraph (d)(2)(i). It requires Exchanges to ensure that coverage takes effect on the date of the court order, and it permits Exchanges to allow qualified individuals to elect an effective date based on paragraph (b)(1). However, it does not provide Exchanges with the option to allow qualified individuals to elect that their coverage begin the first of the month following the date of the event.
We proposed to remove paragraph (b)(2)(v) of this section and to revise paragraph (b)(2)(i) to include the special enrollment period for a court order and redesignate current paragraph (b)(2)(vi) as paragraph (b)(2)(v). These revisions would align the coverage effective dates for all special enrollment periods based on gaining or becoming a dependent, with the exception of gaining or becoming a dependent through marriage. Aligning coverage effective date options ensures that Exchanges provide qualified individuals in similar situations with the same flexibility with regard to coverage effective dates.
We also proposed to modify paragraph (b)(2)(i) so that, in addition to requiring an Exchange to ensure that coverage is effective retroactive to the date of the qualifying event, it may permit the qualified individual or enrollee to elect a coverage effective date of the first of the month following plan selection, rather than the first of the month following the qualifying event, as currently written, or following regular coverage effective dates, in accordance with paragraph (b)(1) of this section. This amendment would streamline Exchange operations and align this coverage effective date option with the accelerated prospective coverage effective date rule as it applies to other special enrollment periods, including the special enrollment period for gaining or becoming a dependent through marriage, as described in (b)(2)(ii) of this section.
Therefore, individuals who qualify for a special enrollment period due to gaining or becoming a dependent through birth, adoption, placement for adoption, or placement in foster care, or through a child support or other court order, will be able to elect from the same alternate coverage effective date options, if offered by their Exchange.
We are finalizing this policy as proposed.
We acknowledge that allowing Exchanges to permit individuals to elect that their coverage take effect on the first of the month following plan selection instead of on the first of the month after the date of their qualifying event will mean that consumers only have one option for their coverage to take effect retroactively—back to the date of their qualifying event—whereas prior to the change, they could request that coverage take effect retroactive to the first of the month after their qualifying event if their Exchange allowed this option. However, we also note that the proposed change adds an accelerated prospective option that is not currently available to these consumers.
Additionally, we believe that, while some Exchanges may need to make system updates based on this change, they will have the flexibility that they need in order to manage the potential impact because Exchanges are not required to offer these alternate coverage effective date options and may delay implementation if necessary. Finally, the alignment of this effective date option with the “first of the month” effective date that also applies to other types of special enrollment periods (in particular the special enrollment period due to gaining or becoming a dependent through a marriage), will also likely generate efficiencies for Exchanges in the long term.
Section 155.420(d)(1) establishes a special enrollment period for qualified individuals who lose certain types of coverage, including minimum essential coverage. As described in paragraph (d)(1)(iii), qualified individuals who lose certain types of Medicaid pregnancy-related coverage not considered minimum essential coverage may also qualify for this special enrollment period. This is to ensure that women losing eligibility for coverage of pregnancy-related services that often meet their primary and specialty health care needs are not left without the option to enroll in a QHP through an Exchange after they lose access to those services.
We proposed to revise paragraph (d)(1)(iii) to include women who lose access to health care services that they were receiving through CHIP coverage for their unborn child. While CHIP coverage for unborn children, provided based on the definition of a child described in 42 CFR 457.10, is considered minimum essential coverage for the unborn child, it is not considered minimum essential coverage for the pregnant woman. Nonetheless, these pregnant women may receive a set of health services comparable to those available to women enrolled in Medicaid pregnancy-related coverage. For this reason, pregnant women who have received prenatal care as part of CHIP coverage for their unborn child may apply and be determined eligible for a hardship exemption from the FFEs so that they are not required to also maintain minimum essential coverage during that time.
The proposed revision to paragraph (d)(1)(iii) would provide a pathway to coverage for new mothers who lose access to health care services provided through unborn child CHIP coverage following the birth of their child, and who are otherwise eligible to enroll in a QHP through the Exchange. Under paragraph (c)(2) of this section, these qualified individuals would have up to 60 days before or after the loss of access to CHIP unborn child coverage to qualify for the loss of coverage special enrollment period and enroll in a QHP. If they select a plan prior to their loss of CHIP unborn child coverage, their Exchange coverage would begin as soon as the first day of the month following the loss of coverage. If they select a plan after the loss of CHIP unborn child coverage, their Exchange coverage would begin either the first of the following month or following regular, prospective coverage effective dates at the option of the Exchange, as provided under paragraph (b)(2)(iv). We believe that this revision is needed to ensure a pathway to coverage for women in the 17 States that offer unborn child CHIP coverage, so that they may maintain access to continuous coverage after the birth of their child.
We are finalizing this policy as proposed.
We proposed to make a technical amendment to update the cross reference to 26 CFR 1.36B-2T in § 155.420(d)(10)(i), regarding the special enrollment period for victims of domestic abuse or spousal abandonment. The temporary regulation under section 36B of the Code originally cited has now been finalized without change to the definition cited in this special enrollment period. This technical correction would not alter the parameters of this special enrollment period.
Commenters supported this proposal; we are finalizing this change as proposed.
Section 155.430 specifies the termination dates for Exchange enrollees. Paragraph (d)(1)(i) of § 155.430 defines “reasonable notice” as at least 14 days before the requested effective date of termination. Paragraph (d)(2) sets forth three possible effective dates for enrollee-initiated terminations made in accordance with paragraph (b)(1): (1) The termination date specified by the enrollee, if the enrollee provides reasonable notice; (2) 14 days after the termination is requested by the enrollee, if the enrollee does not provide reasonable notice; or (3) on a date on or after the date on which the termination is requested by the enrollee, if the enrollee's QHP issuer agrees to effectuate termination in fewer than 14 days, and the enrollee requests an earlier termination effective date. Further, current paragraph (d)(2)(iv) sets the QHP termination effective date for enrollees newly eligible for Medicaid, CHIP, or the Basic Health Program (BHP) as the day before the individual is determined eligible for Medicaid, CHIP, or BHP.
We proposed to remove paragraphs (d)(1)(i) and (d)(2)(i) through (d)(2)(iii) to align the effective dates for all enrollee-initiated terminations on the date on which the termination is requested by the enrollee or on another prospective date selected by the enrollee. We also proposed removing existing paragraph (d)(2)(iv), which states that the QHP termination date for an enrollee newly determined eligible for Medicaid, CHIP or a BHP is the date before the Medicaid, CHIP, or BHP eligibility determination. We invited comment from Exchanges, issuers, and other stakeholders on any burdens these rule changes may impose, as well as whether we should make the changes at the option of the Exchange or the issuer.
We are not finalizing this policy as proposed. Rather, we are restructuring paragraph (d)(2) to improve its readability, and, in response to comments from Exchanges responding to our solicitation of comments, providing additional flexibility to allow Exchanges to retain the current policy or operate under the proposed policy.
A few commenters encouraged flexibility to maintain existing policy and business operations, and others encouraged HHS to allow States to determine how the change would impact their populations, given their Medicaid eligibility processing times, as well as their ability to reach and inform consumers about their need to take action.
This section defines terms that are relevant to this subpart. We proposed to amend the definitions of “Appeal request” and “Appeals entity” by adding a cross reference to proposed section § 155.716(e)” to align with other proposals discussed throughout the proposed rule, and finalized in this rule, regarding SHOP. We did not receive substantive comments specific to this proposal, and are finalizing as proposed.
Section 1311(d)(4)(H) of the PPACA and section 5000A(e)(5) of the Code allow individuals to seek an exemption from the individual shared responsibility provision due to a lack of affordable coverage based on an individual's projected income. Although tax reform legislation enacted in December 2017 reduces to $0 the individual shared responsibility payment for months beginning after December 31, 2018, individuals may still have a need to seek a hardship exemption for 2019 and future years due to a lack of affordable coverage based on projected income. For example, individuals may continue to seek a hardship exemption after 2018 to be eligible for catastrophic coverage.
Section 155.605(d)(2) establishes the circumstances under which an Exchange must determine an applicant eligible for an exemption due to lack of affordable coverage based on projected income. For determining whether affordable coverage is available, paragraph (d)(2) states that the Exchange should use the standards specified in section 5000A(e)(1) of the Code that, among other things, specify that the Exchange should use, for individuals not eligible for employer-sponsored coverage, the annual premium for the lowest-cost bronze plan available in the individual market through the Exchange in the State in the county in which the individual resides.
However, market instability has resulted in limited offerings of plans on the Exchanges in many regions, and there may be individuals who live in a county without a bronze plan. Under the current regulation, the Exchange would not be able to make a determination as to whether an individual not eligible for employer-sponsored coverage who lives in a rating area without a bronze plan is eligible for the exemption due to lack of affordable coverage based on projected income. We proposed to amend paragraph § 155.605(d)(2)(iv), to allow an Exchange to make a determination of lack of affordable coverage based on projected income for individuals not eligible for employer-sponsored coverage using the annual premium for the lowest cost Exchange metal level plan, excluding catastrophic plans, available in the individual market through the Exchange in the State in the county in which the individual resides if there is no bronze level plan sold through the Exchange in that county. Absent this proposed change, individuals may lack access to affordable coverage, but be unable to qualify for an exemption determination from the Exchange due to the Exchange's inability to calculate whether coverage is unaffordable due to the absence of a bronze plan in that county. Under the proposed amendment to § 155.605(d)(2), Exchanges would use the amount of the lowest cost Exchange metal level plan available to the individual when no bronze level plan is available.
Under section 5000A of the Code, an individual must have minimum essential coverage for each month, qualify for an exemption, or make an individual shared responsibility payment. Under section 5000A(e)(1) of the Code, an individual is exempt if the amount that he or she would be required to pay for minimum essential coverage (the required contribution) exceeds a particular percentage (the required contribution percentage) of his or her actual household income for a taxable year. In addition, under § 155.605(d)(2), an individual is exempt if his or her required contribution exceeds the required contribution percentage of his or her projected household income for a year. Finally, under § 155.605(d)(2)(iv), certain employed individuals are exempt if, on an individual basis, the cost of self-only coverage is less than the required contribution percentage, but the aggregate cost of individual coverage through employers exceeds the required contribution percentage and no family coverage is available through an employer at a cost less than the required contribution percentage. Although tax reform legislation enacted in December 2017 reduces to $0 the individual shared responsibility payment for months beginning after December 31, 2018, individuals may continue to seek a hardship exemption based on the required contribution amount after 2018 to obtain catastrophic coverage. Further, the excess of the rate of premium growth over the rate of income growth also is used for determining the applicable percentage in section 36B(b)(3)(A) of the Code and the required contribution percentage in section 36B(c)(2)(C) of the Code. As such, we are continuing to finalize the excess of the rate of premium growth over the rate of income growth and the required contribution percentage for the 2019 benefit year below.
Section 5000A of the Code established the 2014 required contribution percentage at 8 percent. For plan years after 2014, section 5000A(e)(1)(D) of the Code and 26 CFR 1.5000A-3(e)(2)(ii) provide that the required contribution percentage is the percentage determined by the Secretary of HHS that reflects the excess of the rate of premium growth between the preceding calendar year and 2013, over the rate of income growth for that period.
We established a methodology for determining the excess of the rate of premium growth over the rate of income growth for plan years after 2014 in the 2015 Market Standards Rule (79 FR 30302), and we stated that future adjustments would be published annually in the HHS notice of benefit and payment parameters.
Under the HHS methodology, the rate of premium growth over the rate of income growth for a particular calendar year is the quotient of (x) 1 plus the rate of premium growth between the preceding calendar year and 2013, carried out to ten significant digits, divided by (y) 1 plus the rate of income growth between the preceding calendar year and 2013, carried out to ten significant digits.
As the measure of premium growth for a calendar year, we established in the 2015 Market Standards Rule that we would use the premium adjustment percentage. The premium adjustment percentage is based on projections of average per enrollee employer-sponsored insurance premiums from the National Health Expenditure Accounts (NHEA), which are calculated by the CMS Office of the Actuary.
As the measure of income growth for a calendar year, we established in the 2017 Payment Notice that we would use per capita personal income (PI). Under the approach finalized in the 2017 Payment Notice, and using the NHEA data, the rate of income growth for 2019 is the percentage (if any) by which the most recent projection of per capita PI for the preceding calendar year ($53,729 for 2018) exceeds per capita PI for 2013 ($44,555), carried out to ten significant digits. The ratio of per capita PI for 2018 over the per capita PI for 2013 is estimated to be 1.2059028167 (that is, per capita income growth of about 20.6 percent). This reflects an increase of about 4.5 percent relative to the increase for 2013 to 2017 (1.2059028167/1.1540603665) used in the 2019 Payment Notice final rule.
Thus, using the 2019 premium adjustment percentage finalized in this rule, the excess of the rate of premium growth over the rate of income growth for 2013 to 2018 is 1.2516634051/1.2059028167, or 1.0379471610. This results in a required contribution percentage for 2019 of 8.00 * 1.0379471610 or 8.30 percent, when rounded to the nearest one-hundredth of one percent, an increase of 0.25 percentage point from 2018 (8.30358-8.05317).
We sought comment on whether there are other measures of premium growth or income growth that we could use to calculate the required contribution percentage.
Section 155.610(h)(2) describes the timeframe during which the Exchange will accept an individual's application for a hardship exemption. We proposed to make a technical correction to § 155.610(h)(2) to reflect the prior redesignation of paragraph § 155.605(g)(1), which describes the criteria for a hardship exemption, to § 155.605(d)(1) in the 2017 Payment Notice.
Commenters did not oppose this correction, and we are finalizing as proposed.
We previously interpreted the PPACA's provisions regarding the SHOPs to require that all SHOPs provide for employer eligibility, employee eligibility, and certain enrollment functions, including premium aggregation functions.
As we have stated in previously released guidance,
We proposed to remove regulatory burden on SHOPs by removing several of the existing requirements imposed upon the SHOPs, focusing on removing requirements to provide certain functionality that is not expressly required by the PPACA, while still ensuring appropriate implementation of statutorily required functions of the SHOP. Under the proposals, employer groups that are currently enrolled in a SHOP QHP for plan years that began prior to January 1, 2018, would not be affected by the proposed changes to enrollment through a SHOP. We are generally finalizing this rule as proposed, and describe changes to certain of the regulations later in this section of the preamble. The changes will take effect for plan years beginning on or after January 1, 2018, as of the effective date of this rule.
Under the approach we proposed and are finalizing, SHOPs will no longer be required to provide employee eligibility, premium aggregation, and online enrollment functionality for plan years beginning on or after January 1, 2018, effective on the effective date of this rule. The FF-SHOPs, and SBE-FP for SHOPs, will take advantage of these flexibilities. Despite the removal of several regulations on SHOPs, State Exchanges will continue to have the flexibility to operate their SHOPs as they choose, in accordance with applicable Federal and State law. Notably, we received comments to the Request for Information that provided support for this proposed enrollment approach. Moreover, a few State Exchanges currently utilize a similar enrollment approach as is being finalized as a transitional measure that was expected to extend through plan years beginning in 2018. These SBEs have already inquired about continuing to permit enrollment of their SHOP
We are finalizing the modifications throughout the requirements applicable in the SHOPs for plan years beginning on or after January 1, 2018, effective on the effective date of this rule. However, because some groups' plan years that begin prior to the effective date of this final rule will continue beyond the effective date of this rule, both the existing requirements applicable to plans beginning before January 1, 2018, and the new requirements applicable to plans beginning after January 1, 2018 will need to be in place simultaneously. For this reason, we are finalizing our proposal to make many of the existing regulatory sections regarding SHOP applicable for plan years beginning prior to January 1, 2018 only, and new regulatory sections applicable for plan years beginning on or after January 1, 2018. After the effective date of this rule, the new regulatory sections will be effective for all 2018 plans, regardless of whether the plans started prior to the effective date of the rule. Except as described in this rule, we proposed and now finalize that these new regulatory sections will mirror the existing regulatory sections.
Specifically, we proposed to amend §§ 155.705, 155.715, 155.720, 155.725, 155.730, 155.735, 155.740, 156.285 and 157.205 to make each section applicable only to plan years beginning prior to January 1, 2018. Additionally, we proposed to introduce mirroring new sections, applicable for plan years beginning on or after January 1, 2018, at §§ 155.706, 155.716, 155.721, 155.726, 155.731, 155.741, 156.286 and 157.206. We did not propose a new section mirroring current § 155.735, as further explained later in this preamble. We also proposed minor changes to § 155.700. These are described in the sections that follow. We also proposed additional changes related to the proposed new approach to SHOP in §§ 155.106, 155.200, and 156.350, to define the streamlined enrollment approach that groups enrolling in a SHOP QHP in an SBE-FP for SHOP will take when this rule becomes effective. In light of the substantial changes, we have made conforming amendments and updated applicable cross references in these and other regulations, including §§ 147.102, 147.104, 155.500, 156.200, and 156.340.
We are finalizing the following policies as proposed. SHOPs that opt to operate in a leaner fashion, such as the FF-SHOPs, will still assist qualified employers who are small employers in facilitating the enrollment of their employees in QHPs offered in the small group market in the State, consistent with section 1311(b)(1)(B) of the PPACA, because the basic functionalities of an Exchange will still be provided. SHOPs will continue to be required to certify plans for sale through a SHOP, and the following features will still be available: An internet website that displays and provides QHP information, a premium calculator that generates estimated prices of the available QHPs, and a call center to answer questions related to the SHOP. Further, small employers will continue to obtain an eligibility determination from the SHOP website but will enroll in a SHOP QHP by working with a SHOP-registered agent or broker, or with a QHP issuer participating in a SHOP to complete the enrollment process.
An enrollment completed by working with a SHOP-registered agent or broker, or with a QHP issuer participating in a SHOP in the SHOPs that decide to operate in a leaner fashion, like the FF-SHOPs, will be considered to be an enrollment through a SHOP, and an employer will be considered to have offered its employees coverage through a SHOP for purposes of section 45R of the Code (the Small Business Health Care Tax Credit), if the employer: (1) Obtains from the SHOP a favorable determination of eligibility to participate in the SHOP; (2) enrolls in a SHOP QHP offered by an issuer; and (3) chooses to have the enrollment identified as being through the SHOP. If an enrollment meets this definition, the QHP issuer will be required to conduct enrollment with all applicable SHOP rules and policies.
Because SHOPs will be required to determine employer eligibility to participate in a SHOP only, and will not be required to determine employer group members' eligibility to enroll, SHOPs will only be required to handle appeals as they relate to an employer's eligibility in a SHOP, as currently described in § 155.740. If, under the flexibilities described here, employer group members enrolled in a SHOP QHP needed to file an appeal related to their SHOP coverage, they generally will file the appeal directly with the insurance company, or could take advantage of other appeals mechanisms under applicable State and Federal law. If an employer group member enrolled in coverage though a SHOP operating under the flexibilities outlined in this rule and believes that he or she were entitled to a SHOP special enrollment period, but was denied that special enrollment period, the employer group member could file a complaint with the SHOP and the SHOP will investigate. SHOP special enrollment periods will continue to be available to enrollees who experience specified qualifying events. SHOPs that use the new flexibilities, such as the FF-SHOPs, will no longer have the information required to determine employer group members' eligibility for special enrollment periods. Therefore, issuers wishing to participate in such a SHOP will be required to administer special enrollment periods.
SHOPs opting to operate in a leaner fashion, like the FF-SHOPs, will continue to provide employers with the option to offer a choice of plans, consistent with section 1312(a)(2) of the PPACA, by continuing to allow employers to offer their employees a choice of plans, either by coverage level, or, in some States, by participating QHP issuer. Employers will be able to see the SHOP plans available, by coverage level and issuers, in their area using the plan comparison tool available on a SHOP website. Employers who choose to offer a choice of plans to employees would contact the participating QHP issuers whose plans they would like to offer to their employees to obtain the application information necessary in order to enroll in coverage.
Once the necessary information required to enroll is obtained from the QHP issuer or issuers or from the SHOP-registered agent or broker, the employer could disseminate the application information to its employees. The employer could later collect the information from its employees and send it to the applicable QHP issuer or issuers or the SHOP-registered agent or broker. Employers generally will also be responsible for collecting monthly premium payments from employees and sending them to the appropriate issuers. While initially offered to support employers' option to offer a choice of plans across issuers, premium aggregation functions are not a function mandated by the PPACA and therefore may be altered or removed, as previously proposed and now finalized with this rule. SHOP-registered agents and brokers will be able to assist employers in performing these tasks, if
Additionally, to further support employers' option to offer a choice of plans across issuers, under the proposals we are finalizing, an employer's minimum participation rate will continue to be calculated at the employer level, though the SHOPs will not be required to calculate it, and the FF-SHOPs will no longer calculate it. No changes were proposed to the way in which an employer's minimum participation rate is calculated or to the 70 percent minimum participation rate default in FF-SHOPs. Participating QHP issuers will not be permitted to deny enrollment on the basis of failure to meet minimum participation requirements to employers who have been determined eligible to participate in the SHOP, and who have met the applicable minimum participation rate, as specified by the SHOP, even if only one employee in a group wishes to enroll with a particular issuer.
Under the approach we proposed and are finalizing, SHOPs will also still be able to administer the provision at section 1304(b)(4)(D) of the PPACA that guarantees continuing eligibility for growing small employers by limiting the validity of an employer's eligibility determination such that it terminates when the employer makes a change that could end its eligibility under § 155.710(b), by requiring the employer to submit a new single employer application to the SHOP if the employer makes a change that could end its eligibility under § 155.710, and by requiring issuers to be able to distinguish SHOP enrollments from non-SHOP enrollments. Under the flexibilities being finalized, issuers will be expected to rely on the determination of eligibility to reflect the employer's ongoing eligibility to participate in the SHOP, and the IRS will have the option to follow up with an employer for additional information if necessary.
HHS understands that the changes outlined in this final rule will allow SHOPs to adopt changes (and that the FF-SHOPs will adopt such changes) that result in a substantial departure from current operations for participating SHOP QHP issuers, employers, and enrollees. It is important to note that employer groups enrolled in a SHOP plan that began in 2017 in a SHOP that will opt to operate in a leaner fashion, like the FF-SHOPs, will not be affected until their plan year ends, as the current regulations will be in effect for the entirety of a plan that began in 2017. We recognize that some employers have already completed an enrollment that took effect on or after January 1, 2018. The current regulations will also be in place for the beginning of plan year 2018 for those plans that start before the effective date of this rule. But, after the effective date of this rule, the finalized regulations pertaining to plan year 2018 will be effective for all plans that begin or began in 2018, regardless of whether the enrollment occurred prior to the effective date. HHS acknowledged that this transition would create challenges and was concerned about employers enrolling between when rates become available for plan years beginning in 2018 and when the flexibilities in this rule will go into effect. We sought comment on how to best ease this transition and did not receive any comments on this point. In addition, we released guidance on this issue in conjunction with the release of the proposed rule.
Because many comments focused on the general approach we had proposed for SHOPs, we have summarized comments related to SHOP proposals here, with a few exceptions, rather than after summarizing the proposed amendments to each section.
Section 155.700 outlines the general requirements to establish a SHOP and defines certain terms specific to SHOPs. We proposed to amend § 155.700(a) by adding paragraph (a)(1) to make the current requirements applicable for only plan years beginning prior to January 1, 2018. We proposed to add paragraph (a)(2) to describe the general requirements applicable for plan years beginning on or after January 1, 2018. Proposed paragraph (a)(2) more closely aligns with the statutory language in section 1311(b)(1)(B) of the PPACA than existing paragraph (a), and will specify that SHOPs must assist qualified employers in facilitating the enrollment of their employees in small group market QHPs. We believe that the PPACA does not have to be interpreted to require SHOPs to process the enrollment of qualified employees into QHPs, as is required by the current regulation. Instead, we believe it can also be interpreted in a less burdensome way, to require SHOPs to assist qualified employers in facilitating employees' enrollment into QHPs, which will still be provided for under our proposals. We sought comment on this proposal.
We are finalizing as proposed; these changes will be effective as of the effective date of this rule. Comments related to the proposed approach for SHOP are discussed at the beginning of section III.D.9 of this rule.
As discussed in the following section, we proposed to modify the regulatory requirements regarding functions of a SHOP for plan years beginning on or after January 1, 2018, and to introduce those requirements in a new § 155.706. To reflect the proposal that the requirements currently in § 155.705 will apply only for plan years beginning before January 1, 2018, we proposed to amend the heading of § 155.705 and add paragraph (f), to state that the section would apply only for plan years that begin prior to January 1, 2018. We discuss new § 155.706 below.
We are finalizing this policy as proposed. Comments related to the proposed approach for SHOP are discussed at the beginning of section III.D.9 of this rule.
Section 155.705 describes required Exchange functions that are specific to SHOPs. To permit SHOPs to operate in a leaner fashion for plan years beginning on or after January 1, 2018, we proposed several changes to the required functions of a SHOP to become effective as of the effective date of this rule. Under these proposals, which we proposed to introduce in new § 155.706, certain functions that are currently required would become optional for SHOPs for plan years beginning on or after January 1, 2018, and the FF-SHOPs would not provide them. With the exception of the proposed changes to the functions described here, the functions would remain the same as in § 155.705. We proposed only to include the paragraphs in current paragraph (b)(3) of § 155.705, that would be applicable to plan years beginning on or after January 1, 2018, maintaining the currently applicable policy requiring SHOPs to allow employers to select a level of coverage and to offer a choice of QHPs across that level of coverage, and permitting SHOPs to allow employers to offer a choice of all QHPs from a single issuer, or another method of providing employer choice. To provide additional flexibility, we also proposed to codify that State Exchanges may, as the FF-SHOPs have, offer employers a choice of SADPs in their SHOPs. To reflect the proposals described in § 156.150(b) of this document, we proposed that State Exchanges could, and FF-SHOPs would, allow employers to offer a choice of SADPs in their SHOP. If no SADP coverage levels are available, employers would be able to offer a choice of all SADPs offered in an area. We also proposed conforming amendments to the structure of this paragraph.
Because, as discussed earlier in this preamble, premium aggregation functions are not mandated by the PPACA and to maximize the flexibilities associated with operating a SHOP, we proposed to remove required functions related to premium aggregation. Specifically, we proposed that the only premium aggregation function from § 155.705(b)(4) that would be applicable in plan years beginning on or after January 1, 2018, would be an amended version of the function in § 155.705(b)(4)(ii)(A), relating to the continuation of coverage. State Exchanges would be permitted to continue providing remaining premium aggregation functions in their SHOPs currently described at § 155.705(b)(4) if they choose to do so. SHOPs electing not to provide premium aggregation functions, like the FF-SHOPs, would still be required to provide an opportunity for employers to offer employees a choice of plans. In SHOPs not offering premium aggregation functions, we stated that we expected that employers generally would receive premium bills from each of the plans or issuers with which an employee enrolls and will pay premiums to each such plan or issuer. Section 155.705(b)(4)(ii)(A) (which we proposed to include in a revised form in § 155.706) describes the process through which the SHOP may enter into an agreement with a qualified employer related to the administration of continuation coverage. Under the approach for enrollment in a SHOP QHP for plan years beginning on or after January 1, 2018, the FF-SHOPs would no longer facilitate the collection of premiums. Therefore, we proposed that § 155.706(b)(4) would mirror § 155.705(b)(4)(ii)(A), but would not include the provision that permits the FF-SHOPs to limit the service to the collection of premiums related to the requirements under 29 U.S.C. 1161,
Paragraph (b)(7) of § 155.705 describes the SHOP function related to QHP availability in merged markets and paragraph (b)(8) describes the function related to QHP availability in unmerged markets. We proposed to include these functions in § 155.706(b)(7) and (b)(8).
However, under the proposal to streamline SHOP enrollment for plan years beginning on or after January 1, 2018, we proposed to change the references to a “qualified employee” to an “employer group” in both paragraphs, as the SHOP would no longer be required to process employee enrollments.
Paragraph (b)(10) of § 155.705 establishes requirements related to minimum participation rates and SHOP coverage; we proposed to include these requirements in § 155.706(b)(10), with certain modifications. In order to facilitate employers' ability to offer employees a choice of plans through a SHOP, as is required under section 1312(a)(2) of the PPACA, § 155.705(b)(10) requires that any
Section 155.705(b)(11) specifies the requirements related to an online premium calculator. For plan years beginning on or after January 1, 2018, we proposed to modify these requirements and include the modified requirements in § 155.706(b)(11). Specifically, § 155.706 (b)(11) would specify that the premium calculator described in § 155.205(b)(6) must facilitate the comparison of available QHPs. This would reflect that SHOPs would no longer be required to maintain enrollment and premium payment information or administer premium billing, and therefore, would no longer necessarily have employer contribution information. SHOPs would be required to maintain a calculator that facilitates the comparison of available QHPs and would generate premium estimates, but would no longer be required to reflect any employer contribution. Therefore, we proposed to not include the requirements in § 155.705(b)(11)(i) or (ii) in § 155.706(b)(11), since these reflect methods SHOPs would use for determining employer contributions. In the FF-SHOPs, this premium calculator would be where an employer or SHOP-registered agent or broker could go to see a complete listing of all the QHPs available in a given area. The tool has served and would continue to serve as a resource for employers and SHOP-registered agents and brokers. Because we believe the premium calculator requirement at section 1311(d)(4)(G) of the PPACA could be interpreted to apply to only individual market Exchanges based on its reference to APTCs and CSRs, which are not available through SHOPs, we believe that this proposal is consistent with the statute.
Section 155.705(c) generally requires a SHOP to provide data related to eligibility and enrollment of a qualified employee to the applicable individual market Exchange. For plan years beginning on or after January 1, 2018, we proposed that this requirement would apply only in SHOPs that collect employee enrollment data related to eligibility and enrollment of a qualified employee, unless the SHOP is operated pursuant to § 155.100(a)(2).
Finally, we proposed in paragraph (e) that the provisions of the section would be applicable for plan years beginning on or after January 1, 2018.
We are finalizing these policies as proposed, except that we are finalizing minor changes to reflect the changes to the actuarial value requirements for SADP QHPs in § 156.150 of this rule, and small, nonsubstantive changes to the regulatory text for clarity and consistency; these policies will be effective as of the effective date of this rule.
As discussed in the following section, we proposed to modify the regulatory requirements regarding the eligibility determination process for SHOP for plan years beginning on or after January 1, 2018, effective on the effective date of this rule, and to introduce those requirements in a new § 155.716. To reflect that the requirements currently in § 155.715 will apply only for plan years beginning before January 1, 2018, we proposed to amend the heading of § 155.715 and add paragraph (h), to state that the section applies only for plan years that begin prior to January 1, 2018.
We are finalizing this section as proposed. Comments related to the proposed approach for SHOP are discussed at the beginning of section III.D.9 of this rule.
Section 155.715 describes the SHOP eligibility determination process for employers and employees. We proposed to add new § 155.716 to describe the eligibility determination process for SHOPs for plan years beginning on or after January 1, 2018. With the exception of the changes to the process described here, the process will remain the same as in § 155.715. However, this new section will modify and remove some of the requirements in § 155.715. The proposals described in this section will be effective on the effective date of this rule.
Section 155.715(a) requires that before permitting the purchase of coverage in a QHP, a SHOP must determine that the employer or individual who requests coverage is eligible. This requirement means that employers and employees must complete an application to participate in a SHOP. Accordingly, the FF-SHOPs have established certain operational requirements related to submitting an application through the FF-SHOP website, including providing information on the business (including location, Employer Identification Number, and number of employees), and identity verification.
To reduce the barriers on employers to obtain SHOP coverage, we proposed in § 155.716 that SHOPs must determine that the employer who requests coverage is eligible, but that SHOPs generally would not always need to do so before the issuer permits the purchase of coverage in a QHP through a SHOP, for plan years beginning on or after January 1, 2018. This would generally permit an employer to purchase a QHP before obtaining a determination of SHOP eligibility and confirming with the issuer the status of the enrollment as being through the SHOP. As further explained in the preamble to § 156.286, issuers would be expected to establish processes to ensure that they can accurately identify which enrollments are considered SHOP enrollments and which are not. We encouraged employers to obtain an eligibility determination from a SHOP as close to the date in which they purchase a SHOP QHP as possible. We considered establishing a limit on how long an employer can wait between purchasing the QHP and obtaining the determination of eligibility for that QHP to be considered purchased through the SHOP. We solicited comments on whether to establish such a limit, and how long it should be. Ultimately, we are finalizing this policy as proposed, and are not establishing a timeline under which employers must obtain an eligibility determination from a SHOP for their enrollments to be considered through the SHOP.
As a condition of claiming the Small Business Health Care Tax Credit, small employers must be prepared to provide sufficient proof that they meet applicable criteria. Part of the employer's responsibility in providing evidence that it is a small employer eligible for the Small Business Health Care Tax Credit includes the ability to verify not only the purchase of a SHOP QHP, but the ability to produce a favorable eligibility determination from a SHOP. Therefore, employers applying for the Small Business Health Care Tax Credit are also encouraged to obtain an eligibility determination from the SHOP in the taxable year in which they intend to apply for the credit.
Section 155.715(b) requires the SHOP to accept SHOP applications from both employers and employees, and § 155.715(c) provides for the verification of both employer and employee eligibility. For plan years beginning on or after January 1, 2018, we proposed to provide SHOPs flexibility to forgo providing for employee eligibility determinations and related functionality and obligations (and the FF-SHOPs will pursue this flexibility). We proposed that SHOPs would not be required to accept applications by employees or determine eligibility of employees because, under the proposed approach to enrollment in a SHOP, SHOPs will not be required to interact with employees. Proposed paragraphs (b) and (c) of § 155.716 would still require SHOPs to accept a SHOP single employer application form from employers, and to verify employer eligibility subject to provisions like those currently in § 155.715(c)(2) through (4). We have updated and made available a single employer application that SHOPs can use to determine employer eligibility to participate in the SHOP to reflect the new rule at § 155.731, described elsewhere in this preamble. Currently, employee information is primarily collected for purposes of enrollment, and therefore will not be necessary for SHOPs to collect under the approach we are finalizing, allowing SHOPs to operate in a leaner fashion. State Exchanges that intend to maintain more robust SHOP functionalities, in lieu of the flexibilities adopted in this rule, will be permitted to continue to determine employee eligibility. We believe this proposal is consistent with the statute because, as noted above, the PPACA does not have to be interpreted to require SHOPs to provide for employee enrollment functionality, and does not define qualified employees.
Paragraph (d) of § 155.715 describes the eligibility adjustment period. We proposed to include in § 155.716(d) these requirements as they relate to eligibility for employers. However,
To reflect our proposed changes to the employer eligibility verification process, as further described in this section and in the preamble to § 157.205, and our proposal not to include a section mirroring § 155.735 regarding terminations, we are adding a requirement in the paragraphs mirroring paragraphs (d)(3)(i) and (e) of § 155.715 to require the SHOP to notify employers not only of a denial of the employer's eligibility to participate in the SHOP, but also of a termination of the employer's eligibility to participate in the SHOP.
Paragraph (f) of § 155.715 specifies the requirement that the SHOP notify an employee of his or her eligibility to enroll in a SHOP. Because we will not be requiring SHOPs to determine employee eligibility for plan years beginning on or after January 1, 2018, we proposed not to include this requirement in § 155.716. SHOPs that continue to provide employee eligibility functionality should continue notifying employees of their eligibility. In the SHOPs that operate in a leaner fashion, like the FF-SHOPs, we anticipate that the participating QHP issuer or employer will determine the method of employee enrollment and notification, consistent with otherwise applicable Federal or State law.
Paragraph (g) of § 155.715 describes the requirements surrounding communication between the SHOP and QHP issuers in the event of an employer withdrawing from the SHOP and the notification of qualified employees of an employer's withdrawal from SHOP. Under the proposed approach for SHOPs beginning for plan years that begin on or after January 1, 2018, the enrollment and disenrollment processes would be addressed between the employer and the issuer or the agent or broker. Therefore, we proposed not including these requirements in § 155.716.
We further proposed in paragraph (f) of § 155.716 that an employer's determination of eligibility to participate in the SHOP obtained under paragraph (a) remains valid until the employer makes a change that could end its eligibility under § 155.710(b). This could include terminating offers of coverage to employees maintaining full-time status, growing to be a large employer without having maintained continuous SHOP coverage, or moving its principal business address or eligible employee worksites out of the SHOP service area. The employer will be required under new regulations being finalized in part 157 to take further action upon termination of the validity of the determination of eligibility to participate in a SHOP to submit a new application for determination of eligibility or to withdraw from participation in the SHOP. We considered requiring SHOPs to acknowledge an employer's withdrawal from participation in the SHOP within a reasonable time. Alternatively, we considered requiring that employers reapply to determine their SHOP eligibility on an annual basis. We sought comment on these proposals, and ultimately are moving to finalize our proposal without requiring employers to reapply to determine their SHOP eligibility on an annual basis or requiring SHOPs to acknowledge such a withdrawal.
We proposed to specify in paragraph (g) that the provisions in § 155.716 will be applicable for plan years beginning on or after January 1, 2018.
We are finalizing these policies as proposed. These changes will become effective as of the effective date of this rule.
Section 155.720 contains requirements related to the enrollment of employees into QHPs under SHOP. To reflect that our proposed approach would no longer require SHOPs to provide functionality related to enrollment of employees for plan years beginning on or after January 1, 2018, we proposed to amend the heading of § 155.720 and add paragraph (j), to state that the section will apply only for plan years that begin prior to January 1, 2018.
Specifically, we proposed that the requirement in paragraph (b) of § 155.720 that SHOPs establish a timeline and process for QHP issuers and employers to follow regarding purchasing coverage and processing of enrollment would not be applicable for plan years that begin on or after January 1, 2018. State Exchanges that choose to maintain their current operations may continue establishing enrollment timelines, as State law and SHOP technology permit. We also proposed that the requirements to transmit enrollment information on behalf of qualified employers and employees to QHP issuers as described in current paragraph (c), and to process payments as described in current paragraph (d) would not apply after plan year 2017, since SHOPs may not have enrollment or payment information to transmit. We proposed that the requirement in paragraph (e) that SHOPs ensure a QHP issuer notifies a qualified employee enrolled in a QHP of the effective date of his or her coverage would not apply
We are finalizing these policies as proposed. These changes will become effective as of the effective date of the final rule. Comments related to the proposed approach for SHOP are discussed at the beginning of section III.D.9 of this rule.
The approach we are finalizing will not require SHOPs to provide functionality related to enrollment of employees for plan years beginning on or after January 1, 2018, and therefore, we proposed that § 155.720 be inapplicable for those plan years, effective on the effective date of this rule. However, there are requirements in that section related to record retention and IRS reporting that will continue to be applicable with some modifications. We proposed to include modified versions of these requirements in a new § 155.721, titled “Record retention and IRS Reporting for plan years beginning on or after January 1, 2018.”
We proposed that all SHOPs still be required to maintain records of employer eligibility for 10 years, as described in paragraph (f). Because SHOPs utilizing the proposed flexibilities, like the FF-SHOPs, would not have information on employees, we did not propose to continue requiring that SHOPs maintain information on employees.
Section 155.720(i) describes the information a SHOP is currently required to communicate to the IRS for purposes of the Small Business Health Care Tax Credit. We proposed to modify the reporting requirement for SHOPs such that for plan years beginning on or after January 1, 2018, effective on the effective date of this final rule, SHOPs would be required to send the IRS information about the employers determined eligible to purchase a SHOP QHP only upon the request of the IRS. We stated that we believe providing the IRS with a list of employers determined eligible to participate in a SHOP, at the IRS's request, fulfills HHS's reporting responsibility. As mentioned earlier in this document, employers in all States must be able to provide sufficient evidence to the IRS that they meet all the necessary eligibility requirements for the Small Business Health Care Tax Credit, if they intend to apply for it. The IRS may ask employers to produce the aforementioned evidence and employers have a responsibility to produce it. Further, we stated that employers may work with their issuer to verify their contribution information, employee enrollment information, and any other applicable information required to apply for the Small Business Health Care Tax Credit through their tax filings.
We are finalizing these policies as proposed.
As discussed in the following section, we proposed to modify the regulatory requirements regarding enrollment periods under a SHOP for plan years beginning on or after January 1, 2018, and to introduce those requirements in a new § 155.726. To reflect the proposal that the requirements currently in § 155.725 would apply only for plan years beginning before January 1, 2018, we proposed to amend the heading of § 155.725 and add paragraph (l), to state that the section would only apply for plan years that begin prior to January 1, 2018. These changes would become effective as of the effective date of the final rule. We discuss the proposed new § 155.726 below.
We are finalizing these policies as proposed. Comments related to the proposed approach for SHOP are discussed at the beginning of section III.D.9 of this rule.
Section 155.725 describes enrollment periods under SHOP, including the timeline under which employer groups must enroll in SHOP coverage, and the notices the SHOP is required to send related to enrollment periods. We proposed to introduce a new § 155.726, which would retain the rolling enrollment and minimum participation rate provisions of § 155.725(b) and (k), but would remove the requirements applicable to enrollment periods under SHOP other than those related to special enrollment periods for plan years beginning on or after January 1, 2018, to reflect the increased flexibility we proposed. The policies described in this section were proposed to be effective on the effective date of this rule.
Section § 155.725(a) requires that SHOPs ensure that enrollment transactions are sent to QHP issuers and that issuers adhere to coverage effective dates in accordance with this section. We proposed that many previously required enrollment and election periods would no longer apply for plan years beginning on or after January 1, 2018. State Exchanges that continue to provide online enrollment functionality for their SHOP will be able to continue to adhere to these requirements. However, under the proposed approach, some SHOPs (including the FF-SHOPs) may not have enrollment information to communicate to the issuers and may not want to continue setting and enforcing coverage effective dates under the
Paragraph (c) of § 155.725 states that the SHOP must provide qualified employers with an annual election period prior to completion of the employer's plan year and paragraph (d) of § 155.725 requires the SHOP to provide notice of that period in advance. Given that, under the proposed approach for SHOPs for plan years beginning on or after January 1, 2018, SHOPs would not be required to process enrollments, we proposed that these requirements would not apply for plan years beginning on or after January 1, 2018. We anticipated that participating QHP issuers in SHOPs pursuing the proposed approach, like in the FF-SHOPs, would be responsible for setting any requirements around renewals, annual employer election periods, and annual employee open enrollment periods, based on their current practices, and subject to applicable State law and otherwise applicable Federal law, including §§ 147.104 and 147.106. For similar reasons, we proposed that the requirements in § 155.725(e), which requires the SHOP to set a standard open enrollment period for qualified employees, and § 155.725(f), which requires the SHOP to send a notice to the employee about the open enrollment period, would not apply for plan years beginning on or after January 1, 2018.
Section 155.725(g) requires SHOPs to establish and maintain enrollment and coverage effective dates, including waiting periods, for newly qualified employees. However, the amendments we proposed at § 155.716 would remove the requirement for SHOPs to perform employee eligibility determinations, accept and process single employee SHOP application forms, as well as verify employee eligibility for plan years beginning on or after January 1,2018. Furthermore, our proposed amendments not to include paragraphs (c) and (d) of § 155.725 in § 155.726 would remove the requirement for SHOPs to maintain enrollment records for plan years beginning on or after January 1, 2018. SHOPs that utilize these proposed flexibilities, like the FF-SHOPs, may be unable to satisfy the requirements in § 155.725(g). To align with these proposed amendments, we proposed that the requirements in § 155.725(g) would not apply for plan years beginning on or after January 1, 2018. Instead, we anticipated that enrollment timelines, deadlines, and coverage effective dates for newly qualified employees in SHOPs that pursue the proposed approach would be set by employers and issuers consistent with applicable State law and otherwise applicable Federal law, including § 147.116. Further, as noted above, issuers offering plans in SHOPs would still be required to adhere to the guaranteed availability requirements set in § 147.104(b)(1)(i) and the special enrollment period requirements in proposed § 155.726(c).
We also proposed that the requirement in § 155.725(h)(1) that a SHOP establish the effective dates of coverage for initial and annual group enrollments would not apply for plan years beginning on or after January 1, 2018. Because SHOPs utilizing the proposed flexibilities, like the FF-SHOPs, would no longer be involved in processing group enrollments, and would therefore not be able to hold issuers accountable to these enrollment deadlines, we stated that we believed it was more appropriate to permit QHP issuers in SHOPs to set their own enrollment timelines. However, State Exchanges would be permitted to continue establishing these effective dates for their SHOPs. We also proposed to remove paragraph (h)(2) for plan years beginning on or after January 1, 2018, which establishes the effective dates for initial and annual group enrollments in FF-SHOPs, because the FF-SHOPs would utilize the proposed flexibilities. We anticipated that issuers in SHOPs that pursue this approach, like in FF-SHOPs, would set enrollment timelines for employer groups participating in these SHOPs, based on their current practices, and consistent with the market rules set forth in §§ 147.104 and 147.106, and otherwise applicable State law.
We proposed that the special enrollment periods specified in § 155.725(j) would continue to be applicable in the SHOPs for plan years beginning on or after January 1, 2018, and proposed to include these in § 155.726(c). We also proposed that the requirements regarding special enrollment periods in § 155.725(j)(3) would apply for plan years beginning on or after January 1, 2018. However, we proposed to modify the SHOPs' responsibilities with respect to special enrollment periods. As stated earlier in this preamble, under the new flexibilities for SHOPs beginning in plan years starting on or after January 1, 2018, SHOPs would no longer be required to provide functionality related to enrollment of employees. For SHOPs that pursue this flexibility, like the FF-SHOPs, issuers will preliminarily be responsible for completing enrollments, and so we expected issuers would implement enrollment periods. Therefore, we proposed to modify the requirements to reflect that the SHOP's revised role would not be to provide special enrollment periods, but to ensure that QHP issuers offering coverage through the SHOP provide the special enrollment periods set forth in regulation.
We are finalizing these policies as proposed, with one minor non-substantive change to correct the placement of numbering in the regulation text.
As discussed in the following section, we proposed to modify the regulatory requirements regarding application standards of a SHOP for plan years beginning on or after January 1, 2018 and to introduce those requirements in a new § 155.731. To reflect the proposal that the requirements currently in § 155.730 would apply only for plan years beginning before January 1, 2018, we proposed to amend the heading of § 155.730 and add paragraph (h), to state that the section would apply for only plan years that begin prior to January 1, 2018.
We are finalizing these policies as proposed; the policies will be effective on the effective date of the final rule. Comments related to the proposed approach for SHOP are discussed at the beginning of section III.D.9 of this rule.
Section 155.730 describes the requirements for employer and employee applications in the SHOPs. We proposed to modify these requirements for plan years beginning on or after January 1, 2018, and to introduce these modified requirements in § 155.731. With the exception of the proposed changes to the requirements described here, the requirements would remain the same as in § 155.730.
In accordance with our approach allowing SHOPs to operate in a leaner fashion for plan years beginning on or after January 1, 2018, effective as of the effective date of this rule, QHP issuers would complete the process of enrolling qualified employees into coverage in SHOPs that will operate in a leaner fashion, like the FF-SHOPs. In those SHOPs it would not be necessary for a SHOP to collect information necessary for purchasing coverage. Therefore, we proposed to modify the information collection requirements related to the single employer application to require SHOPs to collect only information that would be necessary for SHOPs to determine employer eligibility to participate in the SHOP under § 155.710(b). To more closely align the description of the data elements collected with those standards for eligibility to participate, we proposed to require the SHOP to collect the employer name and address of the employer's locations; information sufficient to confirm that the employer is a small employer; the Employer Identification Number; and information sufficient to confirm that the employer is offering, at a minimum, all full-time employees' coverage in a QHP through a SHOP. SHOPs could collect other information, at their option subject to the limitations in § 155.716(c)(2) and § 155.731(f).
Paragraph (c) of § 155.730 requires the use of a single employee application. We proposed that this requirement would not apply for SHOP beginning for plan years starting on or after January 1, 2018, as the information collected in this application would no longer be necessary, since the SHOP would no longer be required to process employees' enrollment.
Section 155.730(d) permits a SHOP to use a model single employer application and model single employee application provided by HHS, and § 155.730(e) permits the use of HHS-approved alternatives to these model applications. We also proposed to maintain these options, but for consistency with the new approach to SHOP, we proposed not to reference a model single employee application. The model single employer application with the elements described in proposed § 155.731(b) has been updated to reflect these changes.
Paragraph (g) of § 155.730 describes additional application safeguards for SHOP employer and employee applications, which we proposed to maintain in § 155.731(f) with minor amendments to reflect the proposal to eliminate the requirement to collect a single employee application. We also proposed in new paragraph (g) to state that § 155.731 would only be applicable for plan years beginning on or after January 1, 2018.
We are finalizing these policies as proposed. These changes will become effective as of the effective date of this rule.
Section 155.735 outlines requirements related to terminations of SHOP coverage or enrollment. Under our proposed approach, described in detail in the preamble to earlier sections of this final rule, the process of completing enrollments, as well as terminating coverage, could be completed by issuers, and would not be required to be completed by SHOPs operating in a leaner fashion under the flexibilities provided for in this rule, like the FF-SHOPs. Issuers would be expected to comply with otherwise applicable State and Federal law regarding terminating coverage, the timelines and effective dates for termination, and any notice requirements, including those at §§ 147.106 and 156.285. Accordingly, we proposed that this section would be applicable for only plan years beginning prior to January 1, 2018, as described in the proposed amendment to the heading and new paragraph (h), effective on the effective date of this rule. SHOPs maintaining current enrollment functions were encouraged to set termination guidelines and distribute notices for terminations based on nonpayment of premiums or loss of employee eligibility, unless State law requires QHP issuers to send the notices. Because SHOPs, such as the FF-SHOPs, would no longer be required to enroll groups into a SHOP QHP, they would no longer be required to maintain the ability to terminate coverage. We believe new §§ 155.716 and 157.206 sufficiently address terminations of eligibility for participation in a SHOP.
We are finalizing these policies as proposed. Comments related to the proposed approach for SHOP are discussed at the beginning of section III.D.9 of this rule.
As discussed in the following section, we proposed to modify the regulatory requirements regarding employer and employee eligibility appeals in SHOP for plan years beginning on or after January 1, 2018, and to introduce those modified requirements in a new § 155.741. To reflect the proposal that the requirements currently in § 155.740 would apply only for plan years beginning before January 1, 2018, effective on the effective date of this rule, we proposed to amend the heading of § 155.740 and add paragraph (p), to state that the section would apply only
We are finalizing these policies as proposed. Comments related to the proposed approach for SHOP are discussed at the beginning of section III.D.9 of this rule.
Section 155.740 describes the SHOP eligibility appeals process for employers and employees. These provisions describe the applicable definitions, the general requirements to provide for appeals, and employers' and employees' rights to appeal an eligibility determination from the SHOP.
To continue to provide for employer eligibility appeals, we proposed to add new § 155.741, mirroring § 155.740, with the following exceptions. Because we proposed elsewhere that the requirement to provide employees with eligibility determinations and the requirement in § 155.715(f) regarding notification of employee eligibility would no longer apply in plan years beginning on or after January 1, 2018, we proposed not to include a paragraph mirroring § 155.740(d), which describes employees' rights to appeal. We also proposed to omit other references to employee appeal rights, to add references to provide for appeals of terminations of eligibility to participate in a SHOP, and to update cross-references as applicable.
We proposed in paragraph (o) that the provisions of § 155.741 would only be applicable to plan years beginning on or after January 1, 2018, effective on the effective date of this rule.
We are finalizing these policies as proposed. Comments related to the proposed approach for SHOP are discussed at the beginning of section III.D.9 of this rule.
Section 1311(d)(5)(A) of the PPACA permits an Exchange to charge assessments or user fees on participating health insurance issuers as a means of generating funding to support its operations. In addition, 31 U.S.C. 9701 permits a Federal agency to establish a charge for a service provided by the agency. If a State does not elect to operate an Exchange or does not have an approved Exchange, section 1321(c)(1) of the PPACA directs HHS to operate an Exchange within the State. Accordingly, in § 156.50(c), we specified that a participating issuer offering a plan through an FFE or SBE-FP must remit a user fee to HHS each month that is equal to the product of the monthly user fee rate specified in the annual HHS notice of benefit and payment parameters for FFEs and SBE-FPs for the applicable benefit year, and the monthly premium charged by the issuer for each policy under the plan where enrollment is through an FFE or SBE-FP.
OMB Circular No. A-25R establishes Federal policy regarding user fees; it specifies that a user fee charge will be assessed against each identifiable recipient for special benefits derived from Federal activities beyond those received by the general public. As in benefit years 2014 through 2018, issuers seeking to participate in an FFE in the 2019 benefit year will receive two special benefits not available to the general public: (1) The certification of their plans as QHPs; and (2) the ability to sell health insurance coverage through an FFE to individuals determined eligible for enrollment in a QHP. These special benefits are provided to participating issuers through the following Federal activities for the 2019 benefit year in connection with the operation of FFEs:
• Provision of consumer assistance tools;
• Consumer outreach and education;
• Management of a Navigator program;
• Regulation of agents and brokers;
• Eligibility determinations;
• Enrollment processes; and
• Certification processes for QHPs (including ongoing compliance verification, recertification and decertification).
OMB Circular No. A-25R further states that user fee charges should generally be set at a level that is sufficient to recover the full cost to the Federal government of providing the service when the government is acting in its capacity as sovereign (as is the case when HHS operates an FFE). Activities performed by the Federal government that do not provide issuers participating in an FFE with a special benefit are not covered by this user fee.
Based on estimated contract costs, enrollment and premiums for the 2019 benefit year, we proposed to maintain the 2019 benefit year user fee rate for all participating FFE issuers at 3.5 percent of total monthly premiums. We sought comment on this proposal.
State Exchanges on the Federal platform enter into an agreement with HHS to leverage the systems established for the FFEs to perform certain Exchange functions, and to enhance efficiency and coordination between State and Federal programs. Accordingly, in § 156.50(c)(2), we specified that an issuer offering a plan through an SBE-FP must remit a user fee to HHS, in the timeframe and manner established by HHS, equal to the product of the monthly user fee rate specified in the annual HHS notice of benefit and payment parameters for SBE-FPs for the applicable benefit year, unless the SBE-FP and HHS agree on an alternative mechanism to collect the funds from the SBE-FP or State instead of direct collection from the SBE-FP issuers. The benefits provided to issuers in SBE-FPs by the Federal government will include use of the Federal Exchange information technology and call center infrastructure used in connection with eligibility determinations for enrollment in QHPs and other applicable State health subsidy programs, as defined at section 1413(e) of the PPACA, and enrollment in QHPs under § 155.400. As previously discussed, OMB Circular No. A-25R established Federal policy regarding user fees, and specified that a user charge will be assessed against each identifiable recipient for special benefits derived from Federal activities beyond those received by the general public. The user fee rate for SBE-FPs is calculated based on the proportion of FFE costs that are associated with the FFE information technology infrastructure, the consumer call center infrastructure, and eligibility and enrollment functions, and allocating a share of those costs to issuers in the relevant SBE-FPs. A significant portion of expenditures for FFE functions are associated with the information technology, call center infrastructure, and eligibility determinations for enrollment in QHPs and other applicable State health subsidy programs as defined at section 1413(e) of the PPACA, and personnel who perform the functions set forth in § 155.400 to facilitate enrollment in QHPs. Based on this methodology, we proposed to charge issuers offering QHPs through an SBE-FP a user fee rate of 3.0 percent of the monthly premium charged by the issuer for each policy under plans offered through an SBE-FP. This fee would support FFE operations associated with providing the functions described above. We sought comment on this proposal.
We are finalizing the FFE and SBE-FP user fees rates at 3.5 and 3.0 percent
As we describe elsewhere in this rule, for plan years beginning on or after January 1, 2018, effective on the effective date of this rule, we are removing employee eligibility, premium aggregation, and online enrollment functionality through the FF-SHOPs for FFE and SBE-FP SHOP issuers. Given the changes to the functionality for the FF-SHOPs, HHS will not provide these special benefits through the FF-SHOPs or SBE-FP SHOPs after the effective date of the rule. Therefore, we proposed that HHS would not assess a user fee on issuers offering QHPs through FF-SHOPs or SBE-FP SHOPs because these user fees are only charged to issuers who receive special benefits from enrolling individuals through the Federal platform. In instances where enrollment did occur through the Federal platform, for example, for plan years beginning prior to the effective date of the final rule, HHS will continue charging SHOP issuers monthly FFE or SBE-FP user fees, as applicable. We are finalizing this policy as proposed.
Section 2707(a) of the PHS Act, as added by the PPACA, directs health insurance issuers that offer non-grandfathered health insurance coverage in the individual or small group market to ensure that such coverage includes the EHB package, which is defined under section 1302(a) of the PPACA to include coverage that provides for the EHB defined by the Secretary under section 1302(b) of the PPACA; limits cost sharing in accordance with section 1302(c) of the PPACA; and provides either the bronze, silver, gold, or platinum level of coverage, or is a catastrophic plan under sections 1302(d) and (e) of the PPACA. Section 1302(b) of the PPACA states that the Secretary is to define EHB, except that EHB must include at least the following general categories and the items and services covered within the categories: (1) Ambulatory patient services; (2) emergency services; (3) hospitalization; (4) maternity and newborn care; (5) mental health and substance use disorder services including behavioral health treatment; (6) prescription drugs; (7) rehabilitative and habilitative services and devices; (8) laboratory services; (9) preventive and wellness services and chronic disease
Section 1302(b)(4) of the PPACA requires the Secretary, in defining the EHB, to: (1) Ensure that such EHB reflect an appropriate balance among the categories so that benefits are not unduly weighted toward any category; (2) not make coverage decisions, determine reimbursement rates, establish incentive programs, or design benefits in ways that discriminate against individuals because of their age, disability, or expected length of life; (3) take into account the health care needs of diverse segments of the population, including women, children, persons with disabilities, and other groups; (4) ensure the health benefits established as essential not be subject to denial to individuals against their wishes on the basis of the individuals' age or expected length of life or of the individuals' present or predicted disability, degree of medical dependency, or quality of life; and (5) provide that a QHP shall not be treated as providing coverage for EHB unless it meets certain requirements for coverage of emergency services.
To implement section 1302(b) of the PPACA, HHS defined EHB based on a benchmark plan approach, which provided at § 156.100 for the States' selection from one of 10 base-benchmark plans, including the largest health plan by enrollment in any of the three largest small group insurance products by enrollment, any of the largest three employee health benefit plan options by enrollment offered and generally available to State employees in the State, any of the largest three national Federal Employees Health Benefits Program (FEHBP) plan options by aggregate enrollment that is offered to all health-benefits-eligible Federal employees under 5 U.S.C. 8903, or the coverage plan with the largest insured commercial non-Medicaid enrollment offered by a health maintenance organization operating in the State. States were required at § 156.110 to supplement their base-benchmark plan from § 156.100 to ensure the 10 EHB categories were being covered to establish the State's EHB-benchmark plan. Section 156.110 also ensures that the EHB-benchmark plan meets the standards of nondiscrimination and balance of benefits, and allows habilitative services to be determined by the State.
We believe that States should have additional choices with respect to benefits and affordable coverage. As such, we proposed to provide States with additional flexibility in their selection of an EHB-benchmark plan for plan year 2019 and later plan years. In addition to granting States more flexibility regulating their markets, we believed these changes would permit States to modify EHB to increase affordability of health insurance in the individual and small group markets beginning in 2019. We proposed that the current EHB-benchmark plan selection would continue to apply for any year for which a State does not select a new EHB-benchmark plan under this proposal.
In the preamble of the proposed rule, we stated that we were considering establishing a Federal default definition of EHB for plan years further in the future that would allow States continued flexibility to adopt their own EHB-benchmark plans, provided they defray costs that exceed the Federal default. We understood that in developing this type of default definition there are trade-offs in adjusting benefits and services. We gave an example of establishing a national benchmark plan standard for prescription drugs that could balance these tradeoffs and provide a consistent prescription drug default standard across States. We solicited initial comments on this type of long-term approach and the trade-offs in adjusting benefits from the current EHBs with a plan to solicit further comments in the future.
Most commenters opposed a Federal default definition of EHB. Many commenters were concerned that a Federal default definition of EHB would be implemented in the pursuit of seeking arbitrary benefit limits, even at the cost of inferior health outcomes.
Some commenters expressed concern over diminishing the State's flexibility in defining their own EHB, especially since other proposals with regard to EHB concentrated on giving additional flexibility to the States. These commenters also expressed concern over requiring States to defray the costs of benefits in excess of a Federal standard.
Many commenters expressed support for a Federal default EHB definition if such a standard represented a minimum level of benefits required in an EHB-benchmark plan, rather than a maximum level of benefits. Commenters noted that plans should include a wide array of benefits to account for the diverse needs of the population at large. Other commenters supported a Federal default EHB definition to the extent that certain benefits would be included in such a definition.
Most commenters opposed a Federal default definition of EHB as it pertains to a national prescription drug benefit, noting that States and issuers are best positioned to evaluate and respond to prescription drug needs. Many of these commenters expressed concerns similar to those raised regarding a general Federal default EHB definition: Concerns that such a standard would, in the pursuit of arbitrary benefit limits, have a negative impact on health outcomes by inhibiting the availability of needed drugs; establish a maximum level of benefits for EHB-benchmark plans; diminish the States' flexibility to define EHB; and increase the defrayals required by States.
Some commenters noted that a national prescription drug benefit standard would require continuous and frequent updating to account for changes in clinical guidelines and drug innovation. These commenters supported a national prescription drug benefit standard that uses a qualitative approach reliant upon Pharmacy & Therapeutics Committees to respond to such rapid changes, rather than a standard based on providing a minimum number of drugs per category or class.
A few commenters supported a national prescription drug benefit, noting that multi-State issuers face complexity dealing with minimum drug counts which vary widely across EHB-benchmark plans, with no rational medical justification for the variation.
Some commenters expressed concern about the impact of a Federal prescription drug benefit on the ability
To reflect the proposed options in § 156.111 for States to adopt new EHB-benchmark plans for plan years 2019 and later, we proposed to make conforming changes to § 156.100 to explicitly state that the selection process in § 156.100 applies only through plan years beginning in 2018, and § 156.111 applies for plan years beginning after 2018. Because we are finalizing § 156.111 to apply for plan years 2020 and later, we are not finalizing these conforming changes as proposed, but are instead making changes to § 156.100 to state that the selection process in § 156.100 applies only through plan years beginning in 2019, and § 156.111 applies for plan years beginning on or after January 1, 2020.
We proposed to add new § 156.111, which would provide States with the flexibility to update their EHB-benchmark plans more frequently and to select among more options. Specifically, we proposed that a State may change its EHB-benchmark plan by: (1) Selecting the EHB-benchmark plan that another State used for the 2017 plan year
Under the first option, we proposed that a State be permitted to select one of the EHB-benchmark plans used for the 2017 plan year by another State. We did not propose to change the State mandate policy at § 155.170 under this option. Under this proposed policy, we proposed that benefits mandated by State action prior to or on December 31, 2011 could continue to be considered EHB under § 155.170, and would not require the State to defray the costs. Conversely, if a State selects an EHB-benchmark plan from another State using this option, the selecting State would still be required to defray the cost of any benefits included in that State's EHB-benchmark plan that are benefits mandated by the selecting State after December 31, 2011, and that are subject to defrayal under the current regulations.
Under the second option, we proposed that a State be allowed to partially replace its current EHB-benchmark plan, using EHB-benchmark plans used by other States for the 2017 plan year. Under this option, we proposed that a State may replace any EHB category or categories of benefits in its EHB-benchmark plan from the 10 required EHB categories with the same category or categories of benefits from another State's EHB-benchmark plan used for the 2017 plan year. For example, a State may select the prescription drug coverage from another State's EHB-benchmark plan (which might include a different formulary drug count) and a third State's EHB-benchmark plan hospitalization category. Similar to the first option, we proposed that benefits mandated by State action prior to or on December 31, 2011, could continue to be considered EHB under this proposal in accordance with § 155.170, and would not require the State to defray their costs. However, if a State uses this option to replace one or more categories of its EHB-benchmark plan used for the 2017 plan year with a category or categories of benefits from another State's EHB-benchmark plan used for the 2017 plan year, the selecting State would be required to defray the cost of any benefits included in the categories of benefits from the other State's EHB-benchmark plan that are mandated by the selecting State's action after
Lastly, under the third option, we proposed that a State be permitted to select a set of benefits that would become its EHB-benchmark plan using a different process, so long as the new EHB-benchmark plan does not exceed the generosity of the most generous among a set of comparison plans. Under this option, the set of comparison plans would be the State's EHB-benchmark plan used for the 2017 plan year and the plans described in § 156.100(a)(1) that were available as base-benchmark plan options for the 2017 plan year, supplemented as necessary under § 156.110. These plans would include the largest health plan by enrollment in each of the three largest small group insurance products by enrollment from the State's base-benchmark options for the 2017 plan year. We proposed that the State would determine if its proposed EHB-benchmark plan does not exceed the generosity of the most generous of a set of comparison plans using an actuarial certification, developed by an actuary who is a member of American Academy of Actuaries, in accordance with generally accepted actuarial principles and methodologies. For this actuarial certification, we proposed that the State could determine generosity in the same manner as we would use to measure whether the plan provides benefits that are equal in scope of benefits provided under a typical employer plan, described later in this section.
We also recognized that the increased flexibility offered to States under this proposed option to define an EHB-benchmark plan could allow a State to embed any desired benefit mandate into the EHB-benchmark plan, without any requirement to defray the obligation. For this reason, we proposed to apply the benefit mandate defrayal policy under § 155.170 to this option. Specifically, we proposed that benefits mandated by State action prior to or on December 31, 2011 could continue to be considered EHB under this proposal according to § 155.170, and would not require State defrayal. However, if a State selects its EHB-benchmark plan using this option, the State must continue to defray the cost of any benefits mandated by State action after December 31, 2011 that are subject to defrayal under current regulations. For example, if the State selects a set of benefits to become its EHB-benchmark plan under paragraph (a)(3), any benefits mandated by that State after December 31, 2011 that are subject to defrayal under current regulations would not be considered EHB, and the State would be required to defray the cost of any such benefits included in the State's EHB-benchmark plan under this proposed option.
We solicited comments on all of the proposals, including on whether to allow a State to select its EHB-benchmark plan from any of the 10 previous base-benchmark plan options available to the State or other States under § 156.100, supplemented as necessary under § 156.110, on whether a different approach is needed to defray the cost of any benefits mandated by State action, on whether other flexibilities are needed by States under the proposed options, on our proposed approach to limit a State's new EHB-benchmark plan under Option 3, such that it does not exceed the generosity of the comparison plans, and on whether other options should be provided to States to select their EHB-benchmark plans beyond the three proposed options. We are finalizing these new EHB-benchmark plan options as proposed, with one amendment. As further discussed in the comments and responses below, we are extending the proposed requirements at § 156.111(a)(3)(i) and (ii) that ensure that the State's new EHB-benchmark plan does not exceed the generosity of the most generous among a set of comparison plans to all of the State's options to select a new EHB-benchmark plan at § 156.111(a). We are finalizing these requirements at § 156.111(b)(2)(ii).
Other commenters believed that the proposed policy was inconsistent with the statutory requirements that the Secretary define EHB and that the Secretary ensure other EHB consumer protections under section 1302(b)(2), (3), and (4) of the PPACA are incorporated into the definition of EHB. These commenters believed that the Secretary has no authority to delegate defining EHB or its parameters to States or issuers. Commenters also believed that the proposed options allowed States to select an EHB-benchmark plan from among an endless set of options, whereas the prior policy allowed a preset list of 10 plan options per State, with most options being from the State in which the plan was applying. Some commenters also believed that the proposed policy was inconsistent with the statutory requirement that the Secretary update EHB based on gaps in coverage or changes in the evidence identified in the Secretary's report to Congress as established at section 1302(b)(4)(H) of PPACA. Some of these commenters also noted that this report has not been completed.
We believe that States should have additional choices with respect to benefits, which may foster innovation in plan design and greater access to coverage, and provide States with a mechanism for affecting affordability. This approach may balance these considerations in manners different from the balance achieved under the previous benchmark plans. The Secretary is defining an expanded set of options from which the State can select
For this reason, we are finalizing the new options for a State's EHB-benchmark plan, along with additional requirements for the State's selection as detailed later in this preamble. We believe these requirements, when taken together, provide States with significant flexibility while appropriately limiting the range of choices, thereby fulfilling the Secretary's obligation to define EHB. Specifically, the requirement that a State's EHB-benchmark plan provide a scope of benefits that is equal to, or greater than, to the extent any supplementation is required to provide coverage within each EHB category at § 156.110(a), the scope of benefits provided under a typical employer plan, as defined at § 156.111(b)(2), establishes a minimum scope of benefits that is required to be covered as EHB. Furthermore, the requirement that the EHB-benchmark plan cannot exceed the generosity of the most generous among a set of comparison plans, which are those group market plans that comprise the basis for the scope of benefits under the current definition of EHB, further limits the range of benefits that can be considered EHB. Together with the other requirements specified at § 156.111(b)(2), these requirements provide States with flexibility to adjust their States' EHB-benchmark plan within a limited range.
At the same time, this policy also allows a State to retain its current EHB-benchmark plan. This flexibility was not afforded under the previous policy. In fact, the previous default option, which was the largest plan by enrollment in the largest product by enrollment in the State's small group market, could vary between benchmark plan selection years, creating unnecessary disruption for States that were unable to select a benchmark plan. Under the new policy, these States, as well as States that do not wish to make changes, will not be required to do so, and will not need to take action to prevent the disruption caused by a change to the State's EHB-benchmark plan.
We are not completing the report to Congress and the public on the periodic review of EHB under section 1302(b)(4)(G) of the PPACA at this time. We do not believe that a report on EHB at this time will provide conclusive results on the assessments required under section 1302(b)(4)(G) of the PPACA, as a large portion of plans required to comply with EHB are QHPs offered both on and off of the Exchanges. These QHP markets have seen significant changes from year to year since their inception, with the number of issuers offering plans in each market changing on an annual basis and the number of enrollees in these plans fluctuating. Furthermore, the frequent modifications to EHB policies and other related Federal benefit policies, such as guidance on complying with the Paul Wellstone and Pete Domenici Mental Health Parity and Addiction Equity Act of 2008 (MHPAEA) and preventive services regulations, have not allowed these plans' benefit structures to stabilize enough for conclusive analysis. Since the PPACA only requires this report to Congress to be conducted periodically, and we do not believe that conducting this report at this time will establish meaningful conclusions, this report will not be completed at this time. We intend to conduct this report once the market has stabilized, which we believe will be furthered by the policy we are finalizing in this rule.
Other commenters were concerned that the first two options allow States to pick more generous plans, and some commenters recommended preventing States from being able to select an option without being responsible for the costs of the additional benefits. In general, these commenters were concerned that the proposed policy would allow States to select benchmark plans with more generous State mandates. Other commenters were concerned that there is significant variation in benchmark plan coverage of particular services, and some commenters stated that the goal of allowing State flexibility should be secondary to ensuring comprehensiveness of the benefit package.
Other commenters noted that the second option allows the State to define EHB by selecting the least generous benefits for each category, thus creating a standard that does not resemble any existing plan in the market today. Commenters were similarly concerned that the third option could allow a State to greatly reduce the generosity of coverage, even though the definition would still require the coverage of the 10 EHB categories. Some commenters were concerned that the third option was too broad and did not ensure consumer protections to ensure the comprehensive scope of benefits.
In short, this flexibility established under § 156.111(a) is not intended to reduce benefits, but to allow for more innovative benefits within the current benefit requirements. This means that a State's EHB-benchmark plan may not have the exact same benefits and limits as the typical employer plan the State identifies under this policy, but this policy will still result in the State's EHB-benchmark plan providing a scope of benefits equal to, or greater than, to the extent any supplementation is required to provide coverage within each EHB category at § 156.110(a), the scope of benefits provided under a typical employer plan, satisfying the Secretary's obligations at section 1302(b) of the PPACA. Furthermore, as described later in this rule, we are finalizing a definition of a typical employer plan that requires the plan have enrollment and be sold in the State. This definition ensures that regardless of the benchmark plan option selected by the State under this rule, that benchmark plan will be at least equal to the scope of benefits to a popular employer plan that was previously offered in the State's employer plan market.
Furthermore, we encourage States to select EHB-benchmark plans that foster innovation in plan design that would provide greater access to coverage that would ultimately improve affordability. As discussed in the proposed rule, in addition to granting States more flexibility in regulating their markets, one of the goals with this policy was to permit States to modify EHB to increase affordability of health insurance in the individual and small group markets.
A State using the third option will need to ensure that its EHB-benchmark plan satisfies the requirements being finalized at § 156.111(b), such as the requirements to cover items and services in each of the ten statutory categories of EHB; to not have benefits unduly weighted towards any of those categories of benefits; and to provide a scope of benefits equal to (or greater than, to the extent any supplementation is required to provide coverage within each EHB category at § 156.110(a)), the scope of benefits provided under a typical employer plan. Since States have been supplementing their EHB-benchmark plans since the inception of the EHB policy, we expect States to be familiar with categorizing benefits.
We also recognize that States have different processes for selecting a benchmark plan and as a result, the State needs discretion in determining what entity has the authority to select the State's EHB-benchmark plan. We therefore will not dictate which State entity must act to select a State's EHB-benchmark plan, but we may consider providing States with additional technical assistance to aid in their selection under the policy finalized in this rule.
Under the proposed options for States to select a new EHB-benchmark plan, we proposed that a State's EHB-benchmark plan must meet certain requirements established under the PPACA with regard to EHB coverage, scope of benefits, and notice and opportunity for public comment. First, under paragraph (b)(1), we proposed to require that the State's EHB-benchmark plan provide an appropriate balance of coverage for the 10 EHB categories of benefits as established at § 156.110(a) and under section 1302(b)(1) of the PPACA. Second, we proposed at paragraph (b)(2) to define requirements regarding the scope of benefits that must be provided by a State's EHB-benchmark plan. Specifically, we proposed at paragraph (b)(2)(i) that the State's EHB-benchmark plan must be equal in scope of benefits to what is provided under a typical employer plan. This proposed requirement reflects section 1302(b)(2) of the PPACA, which requires the Secretary to ensure that the scope of the EHB is equal to the scope of benefits provided under a typical employer plan, as determined by the Secretary. We proposed to define a typical employer plan as an employer plan within a product (as these terms are defined in § 144.103 of this subchapter) with substantial enrollment in the product of at least 5,000 enrollees sold in the small group or large group market, in one or more States, or a self-insured group health plan with substantial enrollment of at least 5,000 enrollees in one or more States. We sought comment on many parts of this definition, including:
• Whether the definition of a typical employer plan should reflect in substantial part a plan that would be typical in the State in question;
• Whether an appropriate way to measure typicality in that case would be to provide that the typical employer plan be defined to also have at least 100 enrollees enrolled in that plan or product in the applicable State;
• Whether typicality should be defined in other ways, including whether it should be based upon the State's 10 base-benchmark plan options for plan year 2017, supplemented as required to become the State's EHB-benchmark plan under § 156.110;
• Whether the definition of a typical employer plan for this purpose should be limited to plans that already cover all 10 EHB categories;
• Whether the proposed typical employer plan definition should exclude self-insured plans, since States may not have the ability to obtain the required information on those plans; and
• Whether we should provide additional guidance or requirements for the definition of a typical employer plan, such as requiring that the plan selected as a typical employer plan be from a recent year after December 31, 2013, requiring that the plan provide minimum value, or requiring that the plan selected as a typical employer plan not be an indemnity plan or an account-based plan like a health reimbursement arrangement.
Given that the proposed definition of a typical employer plan was a plan with enrollment of at least 5,000 enrollees in one or more States, we believed that the State's option to select another State's EHB-benchmark plan at proposed § 156.111(a)(1) would automatically meet the typical employer plan requirement because each of the available options is an employer plan that had substantial enrollment.
We also solicited comment on whether actuaries could develop a standard of practice for a benefit comparison calculation to determine that a plan is equal to the scope of benefits provided under a typical employer plan that could also apply to determine that a State's EHB-benchmark plan does not exceed the generosity of the most generous plan in accordance with the third option under proposed § 156.111(a)(3). We specifically sought comment on our draft example of an acceptable methodology for comparing benefits of a State's EHB-benchmark plan selection to the benefits of a typical employer plan.
In addition to meeting the typical employer plan requirements, we proposed at paragraph (b)(2)(ii) that the State's EHB-benchmark plan must also not have benefits unduly weighted towards any of the categories of benefits at § 156.110(a) as established under section 1302(b)(4)(A) of the PPACA. Furthermore, we proposed at paragraph (b)(2)(iii) that the State's EHB-benchmark plan must provide benefits for diverse segments of the population, including women, children, persons with disabilities, and other groups as established under section 1302(b)(4)(C) of the PPACA.
At paragraph (c), we proposed that the State must provide reasonable public notice and an opportunity for public comment on the State's selection of an EHB-benchmark plan. We proposed that this process would apply whenever a State changes its EHB-benchmark plan in accordance with proposed § 156.111(a).
Lastly, we proposed at paragraph (d) that a State must notify HHS of the selection of a new EHB-benchmark plan by a date to be determined by HHS for each applicable plan year. We also proposed that if the State does not make a selection by the annual selection date, the State's EHB-benchmark plan for the applicable plan year would be that State's EHB-benchmark plan applicable for the prior plan year. Taken together, these proposed requirements were intended to align with statutory requirements. We affirmed that §§ 156.115, 156.122, and 156.125 would continue to apply to all plans subject to the EHB requirements.
We are finalizing the requirements for a State's EHB-benchmark plan with certain amendments to: (1) Clarify that the State's EHB-benchmark must provide coverage of items and services for at least the 10 EHB categories; (2) add a codification of the currently applicable requirement at § 156.110(d) that the State's EHB-benchmark plans must not include discriminatory benefit designs that contravene the non-discrimination standards defined in § 156.125; (3) modify the definition of a typical employer plan; (4) add a requirement that the State must post a notice of its opportunity for public comment with associated information on a relevant State website; (5) provide that any State EHB-benchmark plan may be no more generous than the most generous among a set of comparison plans, as described above; and (6) codify in regulation text the proposed standard in the preamble of the proposed rule that if a State's benchmark plan selection does not meet the requirements of this section and section 1302 of the PPACA, the State's EHB-benchmark plan will be the State's EHB-benchmark plan applicable for the prior year, as further described under the data collection section below. To reflect the application of the generosity standard to all three options under this regulation, we moved that provision from § 156.111(a)(3) to § 156.111(b)(2), and have renumbered parts of § 156.111(b)(2) for clarity.
We are also adding a new § 156.111(b)(2)(v) to codify the continuing applicability of the currently applicable benchmark plan non-discrimination provisions under § 156.110(d) to the EHB-benchmark plan selection options under § 156.111(a). Specifically, a State's EHB-benchmark plan may not violate the non-discrimination standards defined in § 156.125, which reflects the non-discrimination provisions of section 1302(b)(4) of the PPACA.
As described in the next section, we are finalizing the 2020 deadline for submission of a State's EHB-benchmark plan under § 156.111(a). For plan years after 2020, we intend to announce the annual EHB-benchmark plan selection deadline to States in the annual notice of benefits and payment parameters. Because we expect that the number of submissions for each plan year will vary, we will not be providing a specific date as to when the State's EHB-benchmark plans for a given plan year will be finalized.
Some commenters were particularly concerned that the policy in the proposed rule generally focused on using the definition of EHB to create a ceiling for the scope of benefits. They expressed concern that the generosity standard limits the scope of benefits to certain previous benchmark plan options, instead of providing the floor for the scope of benefits, as they stated PPACA intended the definition of EHB to be. These commenters were concerned that decreased benefits would result in high costs for consumers to access those services.
Some commenters wanted more specificity in the definition of typical employer plan, such as wanting the plan to be specific to the State to ensure compatibility in the State or meet State requirements, be required to cover all 10 EHB categories or minimum benefit standards, be from a recent plan year, constitute MEC, provide minimum value (or some other actuarial value standard), not be an account-based plan, not be a preventive-services-only plan or an excepted benefit plan or not be an indemnity plan. Some commenters supported the definition of a typical employer plan for its flexibility or supported aspects of the proposed definition. Another commenter noted that if a State-specific enrollment requirement is added, current EHB-benchmark plans under the first option may not automatically meet the definition.
Commenters recommended different enrollment thresholds for the typical employer plan, with some commenters noting that substantial enrollment varies by State or the lack of justification for the 5,000 enrollee threshold. Other commenters believed that the proposed policy disregarded the concept of typicality as being the scope of coverage typically seen in employer-based plans or did not believe enrollment should be an indicator for typicality (as typicality is about comparability and enrollment is about size).
First, we are finalizing that the typical employer plan may be one of the selecting State's 10 base-benchmark plan options established at § 156.100 from which the State could select for the 2017 plan year. This definition, which allows the selecting State to continue to select from its previous options, will allow a selecting State to modify its previous base-benchmark plan options to innovate those benefits to better meet the needs of consumers in its market.
Second, we are finalizing that a typical employer plan also may be the largest health insurance plan by enrollment in any of the five largest large group health insurance products by enrollment in the selecting State, as product and plan are defined at § 144.103, provided that: (1) The product has at least 10 percent of the total enrollment of the five largest large group health insurance products by enrollment in the selecting State; (2) the plan provides minimum value, as defined under § 156.145; (3) the benefits are not excepted benefits, as established under § 146.145(b) and § 148.220; and (4) the benefits in the plan are from a plan year beginning after December 31, 2013.
For purposes of this definition, we are applying the Federal definitions of plan and product at § 144.103.
We agree with commenters that self-insured plans have a significantly greater likelihood of being plans with atypical benefit designs. Therefore, this definition for typical employer plan does not include self-insured plans, including health reimbursement arrangements. We also recognize that States would have challenges obtaining information about these other types of plans, especially at the level of detail needed for the plan to be used as a comparison to the State's EHB-benchmark plan. To limit the burden on States to determine which plans in the State would be included in the second set of plans, we are limiting the second set under the definition of typical employer plan to large group market health insurance plans and products.
In response to commenters who recommended that the typical employer plan be required to provide minimum value (MV), we are also finalizing as part of the second prong of the definition of the typical employer plan that the plan must meet MV requirements under § 156.145. Under § 156.145, an employer-sponsored plan provides minimum value only if the percentage of the total allowed costs of benefits provided under the plan is greater than or equal to 60 percent, and the benefits under the plan must include substantial coverage of inpatient hospital services and physician services, characteristics that we believe are reflective of typical employer plans. For example, by requiring the typical employer plan meet MV, outlier plans, such as preventive-services-only plans, which do not provide substantial coverage of inpatient hospital and physician services in accordance with the MV requirement, could not satisfy the second definition of typical employer plan.
To further respond to comments recommending that we ensure that outlier plans are excluded from the definition of typical employer plan, we are finalizing as part of the second prong of the definition a requirement that the plan's benefits are not excepted benefits, as defined under § 146.145(b), and § 148.220. For example, a worker's compensation plan would not meet the second prong of the definition of a typical employer plan. This requirement specifically ensures that the typical employer plan is a major medical plan. Lastly, we are requiring that the benefits in the plan are from a plan year beginning after December 31, 2013. This requirement is consistent with the options under the first prong of the typical employer plan definition, which references plans originally offered in 2014.
In applying the typical employer plan definition, we recognize that States may find that the plans that meet the definition of a typical employer plan may not provide coverage for items and services within each EHB category at § 156.110(a). Therefore, we are finalizing that the State's EHB-benchmark plan must provide a scope of benefits that is equal to, or greater than, to the extent any supplementation is required to provide coverage within each EHB category at § 156.110(a), the scope of benefits provided under a typical employer plan. The purpose of this approach is to permit States' EHB-benchmark plans' scope of benefits not to be equal to the benefits under the typical employer plan definition, only by exceeding the scope of benefits provided by the typical employer plan, and only if necessary to ensure that all EHB categories of benefits are being covered. We believe that these requirements, when taken together, ensure outlier plans are excluded from the definition of a typical employer plan, respond to commenters' concerns regarding the risk that the definition of typical employer plan would include atypical plans and ensure that the requirement for the EHB-benchmark plans' scope of benefits to be equal to that of a typical employer plan can account for benefits within each EHB category at § 156.110(a).
We encourage States to consider, as they select their EHB-benchmark plans, the potential impact on vulnerable populations, and the need to educate consumers on benefit design changes. Specifically, as States work to address the opioid crisis, we urge States to consider whether and how selecting a new EHB-benchmark plan could help address the crisis in their State.
Therefore, in an effort to retain State flexibility under this requirement, with one exception, we are finalizing a policy under which States must provide reasonable public notice and opportunity for public comment, but will look to States to reasonably interpret that requirement. In response to comments, we are finalizing a requirement that the State, regardless of the public comment process it uses to select its EHB-benchmark plan, must post a notice on a relevant State website regarding the opportunity for public comment with associated information.
For States that do not have a public notice and comment process for these purposes, these States should consider using a similar process for public comment to the one established at § 155.1312(a)-(c). We also remind States that any public participation processes must continue to comply with applicable Federal civil rights laws, including those that require covered entities to provide meaningful access for individuals with limited English proficiency, and those that require effective communications for individuals with disabilities, including web accessibility requirements. The public notice process at § 156.111(c) applies whenever a State changes its EHB-benchmark plan in accordance with § 156.111(a).
We proposed data collection requirements at § 156.111(e) for a State that opts to select a new EHB-benchmark plan under § 156.111(a) in any given year, beginning with the 2019 plan year. We proposed that a State must submit documents in a format and manner specified by HHS by a date determined by HHS and proposed four areas of documentation. First, at paragraph (e)(1), we proposed to require documentation that would confirm that the State's EHB-benchmark plan complies with the requirements under proposed § 156.111(a), (b) and (c), which includes the requirement that the 10 EHB categories of benefits are covered under the State's EHB-benchmark plan. This documentation would also include information on which selection option under proposed § 156.111(a) the State is using, including whether the State is using another State's EHB-benchmark plan.
Second, in paragraph (e)(2), we proposed, for a State selecting an EHB-benchmark plan under § 156.111(a)(2) or (3), that the State's documentation must include an actuarial certification and an associated actuarial report from an actuary, who is a member of the American Academy of Actuaries, in accordance with generally accepted actuarial principles and methodologies, affirming that the State's EHB-benchmark plan is equal in scope of benefits provided under a typical employer plan. We proposed that if the State is selecting its EHB-benchmark plan using § 156.111(a)(3), which allows the State considerable flexibility to otherwise select a set of benefits that would become its EHB-benchmark plan, that the actuarial certification and associated report would also affirm that the new EHB-benchmark plan does not exceed the generosity of the most generous among the set of comparison plans specified in paragraph (a)(3). For the actuarial certification, we proposed that these documents, in accordance with generally accepted actuarial principles and methodologies, would include complying with all applicable Actuarial Standards of Practice (ASOP) (including but not limited to ASOP 41 on actuarial communications). We also sought comment on a draft methodology for comparing benefits of a State's EHB-benchmark plan selection to the benefits of a typical employer plan for the actuarial certification and associated actuarial report
Third, we proposed at paragraph (e)(3) that the State would be required to submit an EHB-benchmark plan document that reflects the benefits and limitations in the benchmark plan, including the medical management requirements, a schedule of benefits and, if the State is selecting its EHB-benchmark plan using the option in paragraph (a)(3), a formulary drug list in a format and manner specified by HHS similar to current § 156.120. For a State that chooses an EHB-benchmark plan under proposed § 156.111(a)(1), the State may submit the plan document from the other State's EHB-benchmark plan used for the 2017 plan year to fulfill this proposed requirement. For a State that selects an EHB-benchmark plan under proposed § 156.111(a)(2), the
Lastly, we proposed under paragraph (e)(4) to require the State to submit documentation specified by HHS, which is necessary to operationalize the State's EHB-benchmark plan. This documentation would be used to provide public resources on a State's EHB-benchmark plan and support related templates and tools. We proposed that this documentation would include a complete and accurate EHB summary chart that reflects the State's EHB-benchmark plan and aligns with the documentation that we currently make publicly available on a State's EHB-benchmark plan. For States that choose § 156.111(a)(1) or (a)(2) where the State is developing its benchmark plan based on another State's EHB-benchmark plan, the State could develop this document utilizing information from the EHB summary chart that is currently publicly available.
We proposed that HHS would post the State's EHB summary document and the State's EHB-benchmark plan document on the Center for Consumer Information and Insurance Oversight (CCIIO) website. We also considered posting the State's EHB-benchmark plan confirmations proposed at § 156.111(e)(1).
We proposed that in order for a State's selection of a new EHB-benchmark plan from the proposed options to be accepted, the State's new EHB-benchmark plan must comply with the associated EHB regulatory and statutory requirements, including those under this final rule. If a State's EHB-benchmark plan selection does not meet these regulatory and statutory requirements, the State's current EHB-benchmark plan would continue to apply. We solicited comments on the proposed processes and deadlines for the 2019 and 2020 plan years.
Because EHB-benchmark plan benefits are based on plans that were sold in 2014, some of the benchmark plan documents may not comply with current Federal requirements. For this reason, the State confirmations require the State to confirm that its EHB-benchmark plan meets the requirements to be an EHB-benchmark plan. Since States are typically the primary enforcer of EHB policy, States may take varying approaches to the level of details included in the EHB Summary Chart, as we believe the manner in which the State displays the EHB-benchmark plan in the EHB Summary Chart may be reflective of the State's EHB enforcement strategies.
Furthermore, we also recognize that the States' 2017 EHB-benchmark plans may need conforming edits to comply with other laws and regulations, and to account for any benefits considered EHB under § 155.170. For these reasons, we clarified in the proposed rule that benefits and limits described in the available benchmark plan documents on our website may not be fully applicable due to other laws and regulations. For instance, under section 2711 of the PHS Act, as added by the PPACA, issuers may not impose lifetime or annual dollar limits on EHBs. When lifetime or annual dollar limits are specified in available EHB-benchmark plan documents, States would have removed the dollar limits or converted them to non-dollar limits when interpreting and applying EHB policy. HHS recognizes most States as the primary enforcers of EHB policy. Thus, when a State would use an EHB-benchmark plan that originated in another State under any proposals under § 156.111, we would generally defer to the selecting State's implementation of the benefits and limits consistent with otherwise applicable law, even when such interpretation differs from the originating State's interpretation. Where possible, States should provide clarity on benefits and limits in the documents collected under § 156.111(e) or note differences in the States' EHB summary chart.
Lastly, we are codifying in regulation text at § 156.111(d)(1) a proposed standard that we discussed in the preamble of the proposed rule, under which the State's new EHB-benchmark plan must comply with the regulatory
The purpose of the policy being finalized at § 156.111 is to strike a balance between providing flexibility to allow States' additional options to select their EHB-benchmark plans and ensuring that States' EHB-benchmark plans meet the associated statutory requirements. To that end, the actuarial certification and associated actuarial report are intended to ensure that the scope of EHB is equal in scope to the benefits provided under a typical employer plan, and to provide the information to support the certification from the Chief Actuary of CMS for the Secretary to submit along with a report to Congress, consistent with section 1302(b)(2)(B) of the PPACA. Section 1302(b)(2)(B) of the PPACA requires that the Chief Actuary of CMS certify that the scope of EHB as defined by the Secretary is equal to the scope of benefits provided under a typical employer plan. Through this rule, the Secretary is determining that the actuarial certification and associated actuarial report at § 156.111(e)(2) ensures any EHB-benchmark plan selection is meeting the requirements at section 1302(b)(2)(A) of PPACA; therefore, we are finalizing these requirements.
This includes the requirement that the actuarial certification and associated actuarial report be prepared in accordance with generally accepted actuarial principles and methodologies. This includes all applicable ASOPs. For example, ASOP 41 contains disclosure requirements, including those that apply to the disclosure of information on the methods and assumptions being used and ASOP 50 contains information on determining MV and AV. In accordance with ASOP 41, we would expect that the actuarial report is based on a data analysis that is reflective of an appropriate population.
State actuaries may need flexibility in developing the actuarial certification and report depending on the type of changes that the State is interested in making to its EHB-benchmark plan and depending on the typical employer plan that the State is using for the certification and report. For these reasons, we are finalizing an example methodology with several changes.
Second, we are finalizing the definition of a typical employer plan to establish the minimum level of benefits for the State's EHB-benchmark plan and the generosity standard to establish the maximum level of benefits for a State's EHB-benchmark plan selection. By tying the maximum level of benefits, in part, to certain previous States' EHB-benchmark plan options, the new State EHB-benchmark plan selections are tied to generosity of the current EHB-benchmark plans in the States, which is not what a 102 percent upper bound limit would provide. For these reasons, we believe that creating an additional upper-bound limit under the typical employer plan in the example methodology is not necessary, would be duplicative, and would be difficult to implement with the generosity standard at § 156.111(b)(2)(ii).
Lastly, to support the use of more appropriate data for the actuarial certification and associated actuarial report, we removed the use of small group index rates from the calculation of the expected value. Instead, we provide other examples of acceptable data that an actuary may use, including data acquired from issuers in the State for a recent plan year, and weighted the services and benefits provided in each EHB category. We believe that the changes to the methodology will help inform actuaries on how to approach the actuarial certification and associated report at § 156.111(e)(2).
Commenters generally supported making EHB-benchmark plan changes for the 2020 plan year at the earliest, with some noting that the 2020 timelines aligns with previous
As for guaranteed renewability, under some circumstances, issuers may be permitted to change their products to reflect new requirements for providing EHB as uniform modifications of their products. Otherwise, if the changes to products are deemed to result in the removal of products from the market, issuers would be required to meet the product discontinuance requirements under § 147.106, which generally require at least 90 days advanced notice to the enrollees of the discontinuance.
Currently, to provide EHB, plans are required to provide benefits that are substantially equal to the EHB-benchmark plan. However, an issuer of a plan offering EHB may substitute benefits
In an effort to promote greater flexibility, consumer choice, and plan innovation through coverage and plan design options, we proposed modifying paragraph (b)(1)(ii) to allow States to permit issuers to substitute benefits within the same EHB category
We noted that nothing in this proposal would prohibit plans required to provide EHB from imposing non-dollar limits, unless otherwise prohibited by Federal law.
We are finalizing the proposal with amendments to clarify when issuers may substitute benefits and States' roles in permitting or prohibiting substitution. Specifically, we are finalizing the change to allow issuers to substitute benefits between EHB categories, beginning with plan year 2020, if the State in which the plan will be offered permits such substitution and notifies HHS of its decision to allow substitution between categories. We also add a clarification at § 156.115(b)(3)(i) that plans with substitutions are not relieved of their requirements under § 156.115(a), including the requirement to cover preventive health services, as required under 45 CFR part 147.
We are finalizing 2020 as the first plan year in which issuers, with the permission of the State, may substitute benefits between categories to align with the first year for which States may update their EHB-benchmark plans under § 156.111.
We believe States are best positioned to weigh the benefits of innovative plan design with any effects on State risk pools, and therefore, will only permit substitution between EHB categories in States that have notified HHS that substitution between EHB categories is permitted by the State. Further, because States are generally the primary enforcers of EHB requirements, including the prohibition on discrimination at § 156.125, we believe States can best assure that plan designs meet the needs of their State residents. We anticipate that States will notify HHS of their decision, if any, to allow substitution between EHB categories through the same means States use to notify HHS of an updated EHB-benchmark plan selection under § 156.111. If a State wishes to permit between-category substitution, it will notify HHS, and that notification will be in effect unless and until the State notifies HHS otherwise. States that permit between-category substitution should work with their issuers to ensure they are aware of this option. We plan to post on CCIIO's website a list of States that allow substitution between EHB categories.
Due to concerns including additional burden on State regulators, commenters also requested that if we were to finalize this proposal, States be permitted to bar substitution between EHB categories.
Almost all commenters asked that we consider the increased burden that consumers would face when comparing plans due to plan complexity related to a possible lack of uniformity across EHB benefit categories and across available plans. In particular, commenters noted that it would become more difficult for consumers in States that chose to permit this option to make meaningful comparisons between plans due to the difficulty in determining whether benefits had been substituted between EHB categories and, if so, whether the resulting coverage package adequately met their needs. One commenter added that these difficulties could also undermine the value of the market signals that consumers' choices currently generate to issuers and other key stakeholders.
Finally, in addition to concerns about consumer burden due to increased plan complexity, many commenters also objected to this proposal due to the possibility that it could undermine coverage for services that are crucial for vulnerable consumers and prevent coverage of chronic conditions.
In response to comments, we are finalizing that substitution between categories would only be permitted if the State in which the plan will be offered has notified HHS that substitution between EHB categories is permitted in the State. We recognize that State legislative cycles may make it challenging for States to adopt legislative requirements allowing or prohibiting substitution between categories in time for plan year 2020. By finalizing this notification approach, we seek to make it easier for States to immediately exercise the flexibility provided in this rule.
We appreciate the comment about increased burden on issuers. Because issuers are already familiar with substituting benefits within benefit categories, we do not believe that broadening the policy to allow benefit substitution between benefit categories will create additional burden for issuers. However, if it does, issuers have the discretion to avoid additional burden by choosing not to substitute benefits between EHB categories, even if allowed by their State. If a State chooses, we believe issuers should be permitted to decide whether the additional flexibility in plan design provided by substitution between categories is worth any additional required effort. We also encourage States to consider the impact on issuers as they weigh whether to allow substitution between categories.
We recognize that consumers may face some additional burden in comparing plans when States allow between-benefit substitution and one or more issuers in the State utilize such substitution. However, we believe permitting substitution between categories could offer significant benefit to consumers in the form of more choices, particularly those actively engaged in shopping for health plans. Some consumers are likely to find plans that better meet their needs under this change, because issuers are likely to make substitutions that fulfill consumer demands. Further, we believe States are best positioned to weigh the benefits of innovative plan design with the potential for increased burden for consumers in their individual and small group markets.
We believe that this change will not undermine coverage for vulnerable consumers or prevent coverage of chronic conditions, because issuers will still be required to offer benefits substantially equal to the EHB-benchmark plan, cover each EHB category without undue weight toward any, provide benefits for diverse segments of the population, and refrain from discrimination based on an individual's age, expected length of life, present or predicted disability, degree of medical dependency, quality of life, or other health conditions.
Section 1302(c)(4) of the PPACA directs the Secretary of HHS to determine an annual premium adjustment percentage, which is used to set the rate of increase for three parameters detailed in the PPACA: The maximum annual limitation on cost sharing (defined at § 156.130(a)); The required contribution percentage used to determine eligibility for certain exemptions under section 5000A of the Code;
Under the methodology established in the 2015 Payment Notice and amended in the 2015 Market Standards Rule for estimating average per capita premium for purposes of calculating the premium adjustment percentage, the premium adjustment percentage is calculated based on the estimates and projections of average per enrollee employer-sponsored insurance premiums from the NHEA, which are calculated by the CMS Office of the Actuary. Accordingly, using the employer-sponsored insurance data, the premium adjustment percentage for 2019 is the percentage (if any) by which the most recent NHEA projection of per enrollee employer-sponsored insurance premiums for 2018 ($6,396) exceeds the most recent NHEA estimate of per enrollee employer-sponsored insurance premiums for 2013 ($5,110).
Under § 156.130(a)(2), for the 2019 calendar year, cost sharing for self-only coverage may not exceed the dollar limit for calendar year 2014 increased by an amount equal to the product of that amount and the premium adjustment percentage for 2019, and for other than self-only coverage, the limit is twice the dollar limit for self-only coverage. Under § 156.130(d), these amounts must be rounded down to the next lowest multiple of $50. Using the premium adjustment percentage of 1.2516634051 for 2019 as proposed above, and the 2014 maximum annual limitation on cost sharing of $6,350 for self-only coverage, which was published by the IRS on May 2, 2013,
Commenters noted that while many people with high health needs benefit from a maximum limitation on cost sharing, the percentage increase in 2019 is more than twice the rate of medical inflation and wage growth and far higher than general inflation. Two commenters asked HHS to spread the maximum limitation over the benefit year to reduce the financial burden on chronically ill enrollees whose medical conditions require them to meet the limitation during the first month or quarter of the year.
Sections 1402(a) through (c) of the PPACA direct issuers to reduce cost sharing for EHBs for eligible individuals enrolled in a silver level QHP. In the 2014 Payment Notice, we established standards related to the provision of these cost-sharing reductions. Specifically, in part 156, subpart E, we specified that QHP issuers must provide cost-sharing reductions by developing plan variations, which are separate cost-sharing structures for each eligibility category. At § 156.420(a), we detailed the structure of these plan variations and specified that QHP issuers must ensure that each silver plan variation has an annual limitation on cost sharing no greater than the applicable reduced maximum annual limitation on cost sharing specified in the annual HHS notice of benefit and payment parameters. Although the amount of the reduction in the maximum annual limitation on cost sharing is specified in section 1402(c)(1)(A) of the PPACA, section 1402(c)(1)(B)(ii) of the PPACA states that the Secretary may adjust the cost-sharing limits to ensure that the resulting limits do not cause the AVs of the health plans to exceed the levels specified in section 1402(c)(1)(B)(i) of the PPACA (that is, 73 percent, 87 percent, or 94 percent, depending on the income of the enrollee). Accordingly, we proposed to continue to use a method we established in the 2014 Payment Notice for determining the appropriate reductions in the maximum annual limitation on cost sharing for cost-sharing plan variations. As we discussed above, the 2019 maximum annual limitation on cost sharing is $7,900 for self-only coverage and $15,800 for other than self-only coverage. We analyzed the effect on AV of the reductions in the maximum annual limitation on cost sharing described in the statute to determine whether to adjust the reductions so that the AV of a silver plan variation will not exceed the AV specified in the statute. Below, we describe our analysis for the 2019 benefit year and our proposed results.
Consistent with our analysis in the 2014 through 2018 Payment Notices, we developed three test silver level QHPs, and analyzed the impact on AV of the reductions described in the PPACA to
We then entered these test plans into the proposed 2019 AV Calculator and observed how the reductions in the maximum annual limitation on cost sharing specified in the PPACA affected the AVs of the plans. We found that the reduction in the maximum annual limitation on cost sharing specified in the PPACA for enrollees with a household income between 100 and 150 percent FPL (
In prior years, we have found that for individuals with household incomes of 250 to 400 percent of the FPL, without any change in other forms of cost sharing, any reduction in the maximum annual limitation on cost sharing will cause an increase in AV that exceeds the maximum 70 percent level set in the statute. In the Market Stabilization Rule, we analyzed the effect of reducing the maximum annual limitation on cost sharing based on how we calculated the 2018 reduced maximum annual limitation on cost sharing. We stated that we were not certain what the AV spread of plan designs will be under the finalized policy, whether issuers will in fact reduce the AVs of their base silver plans to the lower end of the
We note that for 2019, as described in § 156.135(d), States are permitted to submit for approval by HHS State-specific datasets for use as the standard population to calculate AV.
Section 1302(d)(2) of the PPACA directs the Secretary to issue regulations on the calculation of AV and its application to the levels of coverage. In the 2013 EHB Rule, HHS finalized the requirements for the calculation of AV for stand-alone dental plans. Specifically, § 156.150 directs SADPs to cover the pediatric dental EHB at one of two AV levels, within an allowable de minimis variation of +/− 2 percentage points.
We proposed to remove the requirement under § 156.150(b) for SADP issuers to meet the low (70 percent +/− 2 percentage points) or high (85 percent +/− 2 percentage points) AV level. We are finalizing the elimination of the requirement that SADP issuers offer EHBs at the low or high levels of coverage. The PPACA does not specifically require SADP issuers to offer coverage at the high or low levels of AV. Removing the AV level requirement will give SADP issuers the opportunity to offer more flexible plan designs to consumers. In previous comments, SADP issuers had noted that it is difficult to meet the low AV requirement and offer preventive care without cost sharing, to which consumers are accustomed in the large group market. Issuers could offer SADPs at varying premiums and levels of coverage, so long as they continue to offer the pediatric dental EHB and meet the annual limitations on cost sharing. We believe that this will allow consumers to select from a greater variety of plans and find one that is more likely to meet their specific needs.
We are not finalizing the elimination of the requirement that SADP issuers certify their plans' level of coverage of EHB, as proposed. We will no longer require certification of the level of coverage since SADPs will no longer be required to be offered at certain levels of coverage. However, HHS will continue to require certification by a member of the American Academy of Actuaries of the AV of the SADPs' coverage of EHB. HHS will consider ways to use the certified AV to provide consumers with additional information to assist in plan selection.
Several commenters supported the proposal. They expected the proposal to result in greater plan choice for consumers. Some also expected SADPs to have greater ability to maintain similar cost sharing from year to year, since SADP issuers would not be required to alter their plans to meet a particular level of coverage. One commenter observed that AV for pediatric EHB is a poor indicator of plan value for SADPs, since most SADP enrollees are adults. Some commenters requested that HHS implement consumer support tools to aid consumers in choosing among SADPs.
We believe consumers benefit when they have a range of plan choices, including some plans with lower premiums and a lower AV. All SADPs will continue to be required to cover the pediatric dental EHB and to limit annual cost sharing on EHB. We expect many SADPs with AVs at and above 70 percent will remain available to consumers, even without a minimum AV standard, because SADPs often provide preventive services without cost sharing. While we acknowledge that removing AV standards will make plan comparison more difficult for some consumers, we note that standardized levels of coverage of pediatric dental EHB are not a useful plan comparison tool for the large share of SADP enrollees who are adults. HHS will consider ways to provide consumers with additional information to assist in comparison and selection of SADPs.
HHS is committed to recognizing States' role as the primary regulator of their insurance markets, and has made a number of recent changes in the QHP certification process to promote this role, and to limit duplicative oversight over issuers. Previously, in the Guidance to States on Review of Qualified Health Plan Certification Standards in Federally-facilitated Marketplaces for Plan Years 2018 and Later,
To further streamline QHP certification by avoiding duplicative reviews, we also previously announced in the QHP Rate Outlier Analysis for Plan Year 2018 and Beyond
In the Market Stabilization final rule, HHS also finalized several standards to affirm the traditional role of States in overseeing their health insurance markets while reducing the regulatory burden of participating in Exchanges for issuers for the 2018 plan year.
In the proposed rule, we continued these efforts to enhance States' role in the QHP certification process. We proposed to continue to enhance the State flexibilities in QHP certification that began for plan year 2018 by identifying additional areas where States are already performing reviews that are duplicative of the Federal QHP certification process and incorporating these reviews into the QHP certification process. In addition to empowering States, we believed these proposals would reduce issuer burden.
We proposed to extend for the 2019 benefit year and beyond policies related to QHP certification standards for network adequacy (§ 156.230) and essential community providers (§ 156.235) that we had finalized in the Market Stabilization final rule for only plan year 2018. Specifically, with respect to network adequacy, we proposed to rely on the States' reviews in States in which an FFE is operating, provided the State has a sufficient network adequacy review process. For the 2019 benefit year and beyond, we proposed to defer to the States' reviews in States with the authority to enforce standards that are at least equal to the “reasonable access standard” defined in § 156.230 and means to assess issuer network adequacy. In States that do not have the authority and means to conduct sufficient network adequacy reviews, we proposed for the 2019 benefit year and beyond to rely on an issuer's accreditation (commercial, Medicaid, or Exchange) from an HHS-recognized accrediting entity, which we proposed would include the three accrediting entities HHS has previously recognized for the accreditation of QHPs: The National Committee for Quality Assurance, URAC, and Accreditation Association for Ambulatory Health Care.
With respect to QHP certification review for the essential community provider (ECP) standard, we proposed for the 2019 benefit year and beyond that we would continue to allow issuers to use the ECP write-in process to identify ECPs that are not on the HHS list of available ECPs and would maintain the 20 percent ECP standard. We believe this standard will substantially reduce the regulatory burden on issuers while preserving adequate access to care provided by ECPs. As in previous years, if an issuer's application does not satisfy the ECP standard, the issuer would be required to include as part of its application for QHP certification a satisfactory narrative justification describing how the issuer's provider networks, as presently constituted, provide an adequate level of service for low-income and medically underserved individuals and how the issuer plans to increase ECP participation in the issuer's provider networks in future years. At a minimum, such narrative justification would include the number of contracts offered to ECPs for the applicable plan year; the number of additional contracts an issuer expects to offer and the timeframe of those planned negotiations; the names of the specific ECPs to which the issuer has offered contracts that are still pending; and contingency plans for how the issuer's provider network, as currently designed, will provide adequate care to enrollees who might otherwise be cared for by relevant ECP types that are missing from the issuer's provider network.
We are finalizing as proposed the policies for network adequacy (§ 156.230) and ECPs (§ 156.235).
For plan years 2019 and later, HHS proposed to further expand the role of States in the QHP certification process for FFEs, including FFEs where the State performs plan management functions. Specifically, we proposed to defer to States for additional review
Section 156.200 sets forth many of the standards a plan must meet to be certified as a QHP. We proposed to amend paragraph (b)(2) to add a cross reference to proposed § 155.706 to align with other changes made throughout this final rule regarding changes to SHOP. Comments related to the proposed approach for SHOP are discussed at the beginning of section III.D.9 of this rule. We are finalizing the change as proposed.
As discussed in the following section, we proposed and are finalizing a modification to the regulatory requirements regarding additional standards specific to SHOP for plan years beginning on or after January 1, 2018 and are introducing those requirements in a new § 156.286. To reflect the proposal that the requirements currently in § 156.285 would apply only for plan years beginning before January 1, 2018, we proposed to amend the heading of § 156.285 and add paragraph (f), to state that the section would only apply for plan years that begin prior to January 1, 2018. We discuss the new standards applicable for plan years beginning on or after January 1, 2018 in the following section. These changes will be effective on the effective date of the final rule.
Comments related to the proposed approach for SHOP are discussed at the beginning of section III.D.9 of this rule; we are finalizing these policies as proposed.
As discussed above, we proposed to make § 156.285, which describes the requirements on QHP issuers participating in SHOPs to accept enrollment and payment information from a SHOP on behalf of an employer or enrollee applicable only for plan years beginning prior to January 1, 2018, and to modify the additional standards specific to QHP issuers participating in SHOPs applicable for plan years beginning on or after January 1, 2018, through the introduction of a new § 156.286. We proposed that new § 156.286 would include only those standards that have been applicable under § 156.285 that would continue to apply to the SHOPs under the proposed approach discussed earlier in this preamble, with minor modifications and clarifications.
We proposed to retain § 156.285(a) as § 156.286(a). However, we proposed to require issuers to accept payment not only from the SHOP, but from a qualified employer or enrollee or a SHOP, to reflect the proposal that a SHOP would not be required to process enrollments and payments. We also proposed not to include the requirement currently in § 156.285(a)(4)(ii), which prohibits issuers in FF-SHOPs from using average enrollee premiums, as the FF-SHOPs and SBE-FPs for SHOP, would no longer be involved in premium payments. For the same reason, we also proposed a narrower version of § 156.285(b) as § 156.286(b), requiring only that issuers adhere to the enrollment periods and processes established by the SHOP consistent with § 155.726, and establish uniform enrollment timelines and processes for qualified employers and group members. We also proposed in § 156.286(c) to include only those requirements from § 156.285(c) that do not relate to the payment and enrollment processes that we have proposed would no longer be required.
We proposed not to include a paragraph mirroring paragraph (d) of § 156.285. This reflects our proposal to remove the requirements contained in current § 155.735, and generally not to impose coverage related timelines on issuers of QHPs through the SHOPs for plans beginning on or after January 1, 2018. We proposed to include a paragraph mirroring § 155.285(e) as § 156.286(d).
Finally, under our proposed and finalized approach, SHOPs will no longer be required to provide employee enrollment functionality. When enrollments are completed by working with SHOP issuers or SHOP-registered agents or brokers, which will be the case for FF-SHOPs, it may not always be immediately apparent to the issuer whether the enrollment is through the SHOP, and whether it is part of an employer's offering a choice of plans. To ensure that issuers offering QHPs through a SHOP do so in a manner that is consistent with our new interpretation of the SHOP provisions of the statute, we proposed to add new paragraphs (e) and (f) in § 156.286. These will require that QHP issuers offering a QHP through the SHOP accept enrollments from groups in accordance with the employer choice policies applicable to the SHOP under § 155.706(b)(3), that they maintain processes sufficient to identify whether a group market enrollment is an enrollment through the SHOP, and they maintain records of SHOP enrollments for a period of 10 years following the enrollment. Proposed paragraph (f) also would require issuers to utilize a uniform enrollment form, as required by section 1311(c)(1)(F) of the PPACA. As noted in the preamble to § 155.716, we intend to update the single employer application to reflect our changes in § 155.731. An issuer will be considered to satisfy this requirement if it uses that application form.
Finally, we proposed in paragraph (g) to state that the requirements contained within § 156.286 are only applicable for
We are finalizing these policies as proposed, with a minor change to § 156.286(a)(1) to reflect that SBEs can continue operating their SHOPs under current practices. These changes are effective as of the effective date of this rule.
We proposed to remove § 156.298 to eliminate meaningful difference standards for QHPs offered through an FFE or SBE-FP. Under this standard, in order to be certified as a QHP, a plan must be meaningfully different from all other QHPs offered by the same issuer of that plan within a service area and level of coverage in the Exchange. As defined in § 156.298(b), QHPs are considered meaningfully different from other plans if a reasonable consumer would be able to identify one or more material differences among five key characteristics between the plan and other plans to be offered by the same issuer.
This meaningful difference standard was implemented to make it easier for consumers to understand differences between plans, and choose the right plan option for them. However, with fewer issuers participating in the Exchange, and fewer plans for consumers to choose from, we proposed to remove these standards, as we no longer believe the requirement is necessary. We believe removing the meaningful difference standard would encourage plan design innovation, by providing more flexibility to issuers in designing plans, and thus increase plan offerings and choice for consumers.
We are finalizing this policy as proposed.
We sought comment on ways in which HHS can foster market-driven programs that can improve the management and costs of care and that provide consumers with quality, person-centered coverage. As we stated in the 2017 and 2018 Payment Notices, we believe that innovative issuer, provider, Exchange, and local programs or strategies can successfully promote and manage care, in a manner that contributes to better health outcomes and lower rates while creating important differentiation opportunities for market participants. We sought comment on ways in which we can facilitate such innovation, and in particular on whether there are regulations or policies in place that we should modify in order to better meet the goals of affordability, quality, and access to care.
We also sought comment on how we may encourage value-based insurance design within the individual and small group markets and ways to support issuers in using cost sharing to incentivize more cost-effective enrollee behavior and higher quality health outcomes, in accordance with section 2713(c) of the PHS Act. Currently, under our rules, issuers have considerable discretion in the design of cost-sharing structures, subject to certain statutory AV requirements, non-discrimination laws and rules,
We would like to encourage issuers to offer HDHPs that can be paired with a health savings account (HSA) as a cost effective option for enrollees. While the proportion of available HSA-eligible HDHPs has been stable in the FFEs, the percentage of enrollees in HDHPs has decreased slightly over the last 3 years as there are certain technical barriers for issuers in offering HDHPs.
We are also interested in value-based insurance designs that focus on cost effective drug tiering structures; address overused, higher cost health services; provide innovative network design that incentivizes enrollees to use higher quality care; and promote use of preventive care and wellness services. We solicited comments on how HHS can better encourage these types of plan designs, and whether any existing regulatory provisions or practices discourage such designs.
Commenters generally supported increasing transparency of health information, but cautioned that consumers would need education and tools in order to make information useful. Some requested that additional information be incorporated into
Others suggested that specific alternative payment options be allowable, such as reference pricing or allowing issuers the flexibility to apply the annual limitation on cost sharing to accumulate differently in tiered networks.
Comments were mixed regarding HSA-eligible HDHPs. Many commenters cautioned that HDHPs do not meet the needs of low-income consumers and urged that HHS provide appropriate explanations and ensure there are consumer protections to make sure consumers make appropriate plan selections. Others noted that
Commenters noted the statutory and regulatory issues with offering HSA-eligible HDHPs on Exchanges, including the misalignment of annual limitations on cost sharing between the PPACA and the Code. Others requested that the IRS expand preventive care safe harbors under section 223(c)(2)(C) of the Code to include services and benefits related to the management of chronic conditions and medications.
One commenter suggested that HHS provide subsidies in the form of HSA contributions instead of cost-sharing reductions. Other commenters offered additional responses related to drug pricing, encouraging HHS to prioritize the transparency of drug pricing in general, and other health care costs. Others noted that with the removal of standardized options, HHS should consider other ways to incentivize issuers to offer at least some QHPs with prescription drugs not subject to the deductible. Other commenters noted specific examples where issuers were waiving cost sharing for high value prescription drugs, such as those to treat high blood pressure. Others suggested that drug rebates could be available to consumers at the point of sale. Additional commenters expressed concerns about changes to the 340B drug discount program.
Section 156.340 sets forth the responsibilities of a QHP issuer and its applicable downstream entities. We proposed to amend paragraph (a)(2) to add a cross reference to proposed § 155.706 to align with other changes made throughout this rule regarding SHOP. Comments related to the proposed approach for SHOP are discussed at the beginning of section III.D.9 of this rule.
We are finalizing the change as proposed.
Section 156.350 describes the eligibility and enrollment standards for issuers that offer QHP coverage in the SBE-FPs. Currently, § 156.350(a)(1) and (2) state that for a QHP issuer to participate in an SBE-FP for SHOP, it must comply with the requirements at § 156.285(a)(4)(ii) and § 156.285(c)(5) and (c)(8)(iii), respectively. However, as discussed elsewhere in this final rule, to align with our proposal regarding the SHOPs, we proposed, and are finalizing, that these referenced requirements at § 156.285 would not be applicable for plan years beginning on or after January 1, 2018, effective on the effective date of this rule. Therefore, we proposed to amend § 156.350(a)(1) and (a)(2) to specify that they only apply through plan years beginning prior to January 1, 2018.
Comments related to the proposed approach for SHOP are discussed at the beginning of section III.D.9 of this rule. We are finalizing the changes as proposed.
A CHIP program is a type of government-sponsored coverage, defined under title XXI of the Act that provides low-cost health coverage to children in low-income families that do not otherwise have health coverage. States may be eligible to receive Federal funds to initiate and expand such programs. A CHIP buy-in program, a “full pay” option where a covered family pays the full premium typically without any Federal or State assistance, often provides similar or identical benefits as the State's CHIP program under title XXI of the Act (the title XXI CHIP program) for children in families that do not financially qualify for the title XXI CHIP program.
However, because the amendment does not designate all CHIP buy-in programs as MEC, we recognize that States and enrollees may have questions regarding whether a particular State's CHIP buy-in program is MEC. To provide States and enrollees with certainty as to whether their coverage constitutes MEC, States will have the option to verify with HHS that their CHIP buy-in program meets the definition of a CHIP look-alike plan. A State may verify that a CHIP buy-in program is a qualified CHIP look-alike plan by submitting documentation to HHS via the Health Insurance Oversight System (HIOS) (as described in section V of the October 31, 2013 Insurance Bulletin
CHIP buy-in plans that are not CHIP look-alike plans may also continue to receive MEC recognition through the MEC application process if the State can demonstrate that the coverage meets substantially all the requirements of title I of the PPACA pertaining to non-grandfathered, individual health insurance coverage.
Under § 156.604, the Secretary may recognize coverage as MEC provided HHS determines that the plan meets substantially all the requirements of title I of the PPACA pertaining to non-grandfathered, individual health insurance coverage (the “substantially all” standard). In the proposed rule, we sought comment on whether HHS should create a new standard of review under which CHIP buy-in programs must “substantially resemble” the title XXI CHIP program under title XXI to qualify as MEC under § 156.604. We are not finalizing a substantially resemble standard of review.
We recognize that social risk factors play a major role in health, and one of our core objectives is to improve patients' outcomes including reducing health disparities. In addition, we seek to ensure that the quality of care furnished by providers and health plans is assessed as fairly and accurately as possible under HHS quality reporting programs, including the Quality Rating System established under section 1311(c)(3) of the PPACA, while helping to ensure that individuals and populations receive high quality, person-centered care. In response to several comments we received from the Request for Information, we continue to assess ways to reduce burden and promote State flexibility in the implementation of all statutorily required Exchange quality programs, including the Quality Rating System, and we continue to prioritize strategies to improve the value for consumers. We received many comments as part of the annual Quality Rating System Call Letter process in response to our request for public comment on whether we should account for social risk factors in the Quality Rating System, which provides quality ratings (or star ratings from 1 to 5 stars) that account for member experience, medical care and health plan administration for QHPs, offered through an Exchange. We did not propose amendments to the Quality Rating System regulations in the proposed rule.
We sought comment as part of this rulemaking on types of social risk factors that may be most appropriate, as well as the methods to account for social risk factors for QHP issuer quality
Commenters provided examples of types of social risk factors and combination of factors that would most appropriately account for QHP issuer quality reporting and clarified which data is readily collected by Exchanges. The types of social risk factors mentioned included patient level data about race and ethnicity; income level; preferred language; disability status; sexual orientation and gender identity; psychological and behavioral status; alcohol and tobacco use; residential address; low-income subsidy eligibility status; and per the recommendations of the National Academies of Sciences, Engineering, and Medicine: Health and Medicine Division,
We proposed to amend paragraph (b)(2) of § 156.1230 to conform with the proposed amendments to § 155.221. The change requires that, prior to a QHP issuer's internet website being used to complete a QHP selection, the QHP issuer must engage a third-party entity in accordance with § 155.221 to demonstrate operational readiness and compliance with applicable requirements. For a discussion of the provisions of this final rule related to third-party entities performing operational readiness reviews, please see the preamble to § 155.221. We are finalizing the amendments to § 156.1230 as proposed.
As discussed in the following section, we proposed to modify the regulatory requirements regarding the qualified employer participation process in a SHOP for plan years beginning on or after January 1, 2018 and to introduce those requirements in a new § 157.206. To reflect the proposal that the requirements currently in § 157.205 would apply only for plan years beginning before January 1, 2018, we proposed to amend the heading of § 157.205 and add paragraph (h), to state that the section would apply only for plan years that begin prior to January 1, 2018.
Comments related to the proposed approach for SHOP are discussed at the beginning of section III.D.9 of this rule. We are finalizing these policies as proposed. These changes will be effective on the effective date of this rule.
Section 157.205 describes requirements for participating SHOP employers. To reflect the proposal to allow SHOPs to operate in a leaner fashion, we proposed several changes to the requirements related to qualified employer participation process in a SHOP for plan years beginning on or after January 1, 2018, and proposed to introduce these requirements in § 157.206. With the exception of the proposed changes to the process described here, the process will remain the same as in § 157.205. The proposals described in this section will be effective on the effective date of the final rule.
Paragraph (d) of § 157.205 requires a qualified employer to submit any contribution towards the premiums of any qualified employee according to the standards and processes described in § 155.705. Because we proposed that the requirements in § 155.705 regarding
Paragraph (e)(1) of § 157.205 describes obligations of qualified employers to employees hired outside of the initial or annual open enrollment periods. We proposed in § 157.206(d) that qualified employers must provide employees hired outside of the initial or annual open enrollment period with information about the enrollment process. We proposed that the requirement in paragraph (e)(1) of § 157.705, which requires qualified employers to provide these employees with an enrollment period in accordance with § 155.725(g), would not be included in § 157.206, as the requirement in § 155.725(g) will not be applicable for plan years beginning on or after January 1, 2018. We also proposed that the requirement in § 157.205(e)(2) to provide information about the enrollment process in accordance with § 155.725 would not apply for plan years beginning on or after January 1, 2018 to reflect that the process provided for in many of the provisions in § 155.725 will not apply for those plan years.
We also proposed that the requirements in § 157.205(f) regarding the process for notifying the SHOP in the event the eligibility status of an employee, or employee's dependent has changed would not apply for plan years beginning on or after January 1, 2018. Under the approach finalized in this rule for plan years beginning on or after January 1, 2018, SHOPs will not be required to process employee enrollment, so there will be no reason for all qualified employers to provide such information.
Further, we proposed that the requirement in § 157.205(g) that qualified employers adhere to the annual employer election period under § 155.725(c) would not apply for plan years beginning on or after January 1, 2018. Elsewhere, we finalized that the annual employer election period provision in § 155.725(c) will not apply for those plan years, and this change reflects that removal.
Finally, we proposed in paragraph (e) of § 157.206 to include new requirements for qualified employers reflective of the proposed approach for SHOPs generally. First, since we proposed in § 155.716(f) that an employer's determination of eligibility to participate in the SHOP remains valid until the employer makes a change that could end its eligibility under § 155.710(b), we proposed in § 157.205(e)(1) that employers must submit a new application to the SHOP if the employer makes a change that could end its eligibility under § 155.710 or withdraw from participation in the SHOP. Second, because under the changes we have finalized elsewhere in this rule, SHOPs will not be required to process group enrollments, and therefore will not necessarily communicate with QHP issuers about employer eligibility determinations, we proposed to require employers to notify the QHP issuer of an unfavorable eligibility determination. However, we proposed that the employer be required to provide the notification within 5 business days of the end of any applicable appeal process under § 155.741. Specifically, the end of the appeal process could occur when the time to file an appeal lapses without an appeal being filed, when the appeal is rejected or dismissed, or when the appeal process concludes with an adjudication by the appeals entity, as applicable. We also proposed in paragraph (e)(3) to describe the employer's obligations regarding loss of eligibility to participate in a SHOP or termination of enrollment or coverage through the SHOP. Given that under the approach finalized in this rule there will not necessarily be communication between the SHOP and a participating QHP issuer regarding employer eligibility, enrollment, or terminations, there may be no way for the SHOP to notify an issuer in the event an employer becomes ineligible to participate in SHOP. Therefore, we proposed to add paragraph (e)(3) to require employers to notify an issuer of a loss of eligibility to participate in SHOP, or a desire to terminate SHOP enrollment or coverage.
We proposed in paragraph (f) of § 157.205 that the section would apply for plan years beginning on or after January 1, 2018, only.
Substantive comments relating to our proposals regarding SHOP are addressed in section III.D.9 of this rule, as well as in the preamble discussing §§ 156.285 and 156.286. We are finalizing new § 157.206 as proposed, with minor changes to paragraphs (e)(2) and (e)(3). As noted in the preamble to the SHOP sections in part 155, State Exchanges are encouraged to continue to operate their SHOPs as they do today, or design a SHOP within the bounds of the flexibilities being finalized within this rule. To ensure that SHOPs can continue to operate as they do today, we are providing flexibility to employers to allow them not to notify issuers of determinations of ineligibility to participate in the SHOP or their desire to terminate their participation in the SHOP in cases where the SHOP has notified the issuer. We are making this change to recognize that State-based SHOPs may continue to provide these notifications, in which case employers should not be required to provide duplicative notifications. Section 156.206 will become effective as of the effective date of the final rule.
Section 2718 of the PHS Act requires that Federal and State taxes be reported, but that such amounts be excluded from premium revenue when calculating an issuer's MLR and accompanying rebates. However, the statute does not define what is included in Federal and State taxes. The MLR December 1, 2010, interim final rule (75 FR 74864) interprets this language and broadly describes Federal and State taxes that must be reported but are excluded from premiums in the MLR and rebate calculations, and Federal and State taxes that must be reported and are not excluded from premiums in MLR and rebate calculations. In order to provide consistency and clarity for MLR reporting, HHS amended § 158.162 in the 2016 Payment Notice (80 FR 10750) to specify that all issuers must include employment taxes in earned premiums and must not deduct such taxes in the MLR and rebate calculations starting with the 2016 MLR reporting year.
However, we received several comments in favor of allowing issuers to deduct such taxes from these calculations in response to the Request for Information. Therefore, in the proposed rule, we invited comments on whether, in order to encourage issuer participation and competition in the markets, HHS should revise paragraph (a)(2) and paragraph (b)(2)(iv) of § 158.162 to allow all issuers to deduct Federal and State employment taxes from premiums in their MLR and rebate calculations, starting with the 2017 MLR reporting year for reports to be filed by July 31, 2018.
We solicited comments on this approach from all stakeholders, including on whether we should instead amend the MLR regulations to collect the employment tax data separately from other tax data as an informational item on the MLR Annual Reporting Form to gather data to inform a decision regarding whether to amend the regulation for future years, and whether changing the treatment of employment
For a discussion of the proposed amendment to § 158.170(b) regarding the description of the allocation method for quality improvement activity (QIA) expenses and a summary of the comments received and responses provided, please see the preamble to § 158.221. We are finalizing the change as proposed.
We proposed amending § 158.221 by adding new paragraph (b)(8) to provide issuers with an option to report quality improvement activity (QIA) expenses as a single fixed percentage of premium amount starting with the 2017 MLR reporting year (for reports to be filed by July 31, 2018). We also proposed conforming amendments to § 158.170(b) (Allocation of expenses) to recognize the new proposed option for reporting QIA expenses.
Consistent with the NAIC's recommendation to HHS,
In the course of conducting the MLR audits, HHS observed that the current MLR regulations require a substantial effort by issuers to accurately identify, track and report QIA expenses. HHS has also observed that, between 2011 and 2015, issuers that did report QIA expenses have reported spending, on average, a consistent percentage of premium on total QIA: approximately 0.7 percent in 2011, and 0.8 percent in 2012 through 2015.
Given issuers' relatively low and consistent reported expenditures on QIA and the significant burden associated with identifying, tracking and reporting these expenditures, we proposed adding § 158.221(b)(8) to permit issuers an option to report on their MLR reporting form a single QIA amount equal to 0.8 percent of earned premium in the relevant State and market, in lieu of tracking and reporting the issuer's actual expenditures for QIA, as defined in § 158.150 and § 158.151. The accompanying proposed amendments to § 158.170(b) would require issuers that elect the option to include 0.8 percent of earned premium for QIA expenses to indicate as such when describing the allocation method used for QIA expenses. Issuers that spend more than 0.8 percent of earned premium on QIA would have the option to report the total actual, higher amount spent and, if choosing this option, would have to report QIA in the five categories described in § 158.150(b)(2)(i)-(v), as well as comply with the allocation of expenses requirements established under § 158.170.
We are finalizing this policy as proposed, except that, in response to comments, we are specifying, as described below, how the optional QIA reporting method may be used across affiliated issuers, markets, and years.
We proposed to amend 45 CFR part 158, subpart C to modify the process and criteria for the Secretary to determine whether to adjust the 80 percent MLR standard in the individual market in a State. Because the majority of comments focused on the broader merits of amending subpart C, rather than on the specific sections, we address all comments after summarizing the proposed amendments to each section.
Section 2718(d) of the PHS Act provides that the Secretary may adjust the MLR standard in the individual market if the Secretary determines it appropriate on account of the volatility of the individual market due to the establishment of Exchanges. The MLR December 1, 2010, interim final rule (75 FR 74864) set forth the framework for a State to request such an adjustment and the process and criteria for the Secretary to determine whether to grant a State's request. Subpart C of 45 CFR part 158 specifies that the adjustment request
Because in the current environment, it generally is not the MLR standard in isolation but rather factors that, taken together, can contribute to instability of the individual market in certain States, the current framework in subpart C restricts the States' ability to obtain adjustments to the MLR standard as part of innovative solutions for stabilizing their individual markets. Therefore, as outlined below, we proposed to make amendments throughout subpart C of part 158 to allow for adjustments to the individual market MLR standard in any State that demonstrates that a lower MLR standard could help stabilize its individual market, and to streamline the process for applying for such adjustments to reduce burdens for States and HHS.
For the reasons described above, we proposed to amend § 158.301 to permit the Secretary to adjust the individual market MLR standard in any State if the Secretary determines that there is a reasonable likelihood that an adjustment to the 80 percent MLR standard will help stabilize the individual market in that State. We are finalizing the amendments as proposed.
We proposed to amend § 158.321 to modify the information that a State must submit to the Secretary with its request for an adjustment to the 80 percent MLR standard in its individual market. Specifically, because we sought to make the MLR adjustment process less burdensome on States and make adjustments available to enable States to develop innovative solutions for stabilizing their individual markets, we proposed to remove the requirements that the State must describe the State MLR standard and formula for assessing compliance (§ 158.321(a)), its market withdrawal requirements (§ 158.321(b)), and the mechanisms available to the State to provide consumers with options for alternate coverage (§ 158.321(c)). Additionally, we proposed to redesignate paragraph (d) as paragraph (a) and to revise the redesignated paragraph to describe the information the State must submit regarding the State's individual health insurance market, as outlined below.
We also proposed to replace the requirement previously codified at § 158.321(d)(1) that a State provide detailed product-level enrollment and premium data with a requirement at § 158.321(a)(2) to submit information only on the total number of enrollees (life-years and covered lives) for each type of coverage sold or renewed in the State's individual market. Similarly, we proposed to eliminate the requirement previously codified in § 158.321(d)(1) to submit product-level premium data in favor of the total earned premium data in the proposed § 158.321(a)(1), and to eliminate the § 158.321(d)(1) requirement to submit the issuer's individual market share.
We proposed to continue to require States to include information on total earned premium (proposed § 158.321(a)(1)) and total agent and broker commission expenses (proposed § 158.321(a)(3)) for each type of coverage sold or renewed in the State's individual market, as described in more detail below, as well as the risk-based capital (RBC) level (proposed § 158.321(a)(5)), which, due to the manner in which RBC is calculated, would only be appropriate to report at the issuer level, rather than for each type of coverage. We also proposed to revise the accompanying regulation text for these data elements for readability. We further proposed that State requests should include information on total incurred claims (proposed § 158.321(a)(1)) for each type of individual market coverage described below, in lieu of the previous more burdensome requirement to provide reported and estimated individual market MLRs (§ 158.321(d)(2)(ii) through (iii)).
We proposed to modify these requirements to require States to only include the information for each issuer actively offering individual market coverage. We also proposed to add a new § 158.321(b) to require that a State request include the individual market data required in the proposed new § 158.321(a)(1) through (4) and (6) separately for each issuer actively offering individual market plans in that State group by the following categories, as applicable: On-Exchange, off-Exchange, grandfathered health plans as defined in § 147.140, coverage that meets the criteria for transitional policies outlined in applicable guidance,
To further reduce the burden on States, we proposed to remove the requirements to provide net underwriting profit for each issuer's total business in the State and after-tax profit and profit margin for the individual market and total business in the State (§ 158.321(d)(2)(vii)), as well as to rename the remaining requirement to provide the individual market “net underwriting profit” to “net underwriting gain” to more accurately reflect the accounting term (proposed § 158.321(a)(4)). We also proposed to delete the requirement to provide information on estimated MLR rebates (§ 158.321(d)(2)(v)). Additionally, we proposed to revise the language at current paragraph § 158.321(d)(2)(ix), proposed to be redesignated at § 158.321(a)(6), to require the State to provide information not only on notices by issuers covered in § 158.321(a) of market exits, but also the equally or more pertinent issuer notices of beginning to offer coverage in the individual market, as well as ceasing or commencing offering individual market coverage on the Exchange or in specific geographic areas (for example, counties); and to add a new § 158.321(c) to require similar information on issuers not actively offering coverage in the individual market that have indicated an intent to enter or exit the individual market, including ceasing or commencing offering individual market coverage on the Exchange or in specific geographic areas. Lastly, we recognize that in many situations the information proposed to be required in § 158.321(a) will only be available for the preceding calendar year, but we proposed to provide States with an option to also include information for the current year (where available), which may be more
We are finalizing the amendments as proposed, with one correction to § 158.321(b) to indicate that the information required in paragraph § 158.321(a)(5) is the only information that must be provided at the issuer level.
To reduce the burden on States, we proposed to remove paragraphs (a), (c) and (d) of § 158.322, which would remove the requirements for a State to justify how its proposed adjustment was determined, and to estimate rebates that would be paid with and without an adjustment because HHS can make these estimates instead of the State. Consistent with our proposed changes to § 158.301, we proposed to revise § 158.322 to require the State to both provide its proposed, adjusted MLR standard and explain how this proposed standard would help stabilize its individual market. We also proposed to delete current paragraph (b), which requires an explanation of how an adjustment would permit issuers to adjust current business models and practices in order to meet an 80 percent MLR as soon as is practicable, to further reduce burden on States submitting adjustment requests.
We are finalizing the amendments as proposed.
Section 158.330 lists the criteria that the Secretary may consider in determining whether to approve a State request to adjust the 80 percent MLR standard for the individual market. We proposed amendments throughout the section to reflect the proposal in § 158.301 to allow adjustments if the Secretary determines the adjustment would help stabilize the individual market in that State, and the proposed changes to the information requirements in § 158.321. Specifically, we proposed conforming amendments to the introductory text of § 158.330 to provide that the Secretary may consider the identified criteria when assessing whether an adjustment to the individual market MLR standard would be reasonably likely to help stabilize the individual market in a State that has requested such an adjustment. We proposed to replace the information currently outlined at § 158.330(a)(1)-(4) regarding individual market issuers reasonably likely to exit the State with information regarding the number and financial performance of issuers actively offering individual market coverage on-Exchange, off-Exchange, grandfathered health plans as defined in § 147.140, coverage that meets the criteria for transitional policies outlined in applicable guidance, and non-grandfathered single risk pool coverage; the number of issuers reasonably likely to cease or begin offering such individual market coverage in the State; and the likelihood that an adjustment would increase competition in the State's individual market, including in underserved areas (proposed § 158.330(a)). We proposed to delete the existing criteria captured at § 158.330(b) related to consideration of the number of individual market enrollees covered by issuers that are reasonably likely to exit the State's individual market absent the requested adjustment because the goal of a State request for adjustment may be to ensure that health insurance coverage is available to all, rather than a certain percentage of, consumers who want it, and that consumers not only have coverage, but also a choice of several issuers. We proposed conforming amendments to the criteria currently captured at § 158.330(c), proposed to be redesignated at § 158.330(b), regarding whether an adjustment might improve consumers' access to agents and brokers. Similar to the proposed amendments to § 158.321 described above to remove the requirement for States to provide information on available mechanisms to provide alternate coverage, we proposed to replace the current criteria outlined at § 158.330(d)(1)-(5) with consideration of information on the capacity of any new issuers or issuers remaining in the individual market to write additional business in the event one or more issuers were to cease or begin offering individual market coverage on Exchanges, in certain geographic areas, or in the entire individual market in the State (proposed § 158.330(c)). We proposed to retain and modify the existing criteria at § 158.330(e), proposed to be redesignated at § 158.330(d), on the impact on premiums charged, and on benefits and cost sharing provided, to consumers by issuers remaining in or entering the individual market in the event one or more issuers were to cease offering individual market coverage on the Exchange, in certain geographic areas, or in the entire individual market in the State. Finally, we proposed to retain the existing criteria at § 158.330(f), proposed to be redesignated at § 158.330(e), for consideration of any other relevant information submitted by the State.
We are finalizing the amendments as proposed.
Because the format in which States may submit requests for adjustments may not comply with Federal requirements for documents posted on Federal websites, some of these documents may not be able to be posted directly to the applicable Federal website. For example, a State may submit spreadsheets containing data or copies of issuer letters in a format that is not accessible for individuals with visual impairments. However, HHS is committed to transparency and making this information promptly available to the public. HHS is also committed to providing accessible information to members of the public, including individuals with disabilities, and will provide such individuals with accessible copies of documents submitted by States unless doing so would impose an undue burden on the agency. Therefore, we proposed to amend § 158.341 to reflect that Federal requirements for documents posted on Federal websites may not permit these documents to be posted, and to specify that instructions for the public to access information on requests for adjustment to the MLR standard submitted by States will be provided on the Secretary's internet website. We are finalizing the amendments as proposed, with a non-substantive change to the regulatory text.
We proposed to make conforming amendments to § 158.350, which describes the information that a State must submit with a subsequent request for an adjustment to the MLR standard, to make this information consistent with our proposed changes to § 158.301 and § 158.330. We are finalizing the amendments as proposed.
The following is a summary of the public comments received on these proposals and our responses.
Under the Paperwork Reduction Act of 1995, we are required to provide 30-day notice in the
• The need for the information collection and its usefulness in carrying out the proper functions of our agency.
• The accuracy of our estimate of the information collection burden.
• The quality, utility, and clarity of the information to be collected.
• Recommendations to minimize the information collection burden on the affected public, including automated collection techniques.
We solicited public comment on each of the required issues under section 3506(c)(2)(A) of the PRA for the following information collection requirements.
To derive wage estimates, we generally used data from the Bureau of Labor Statistics to derive average labor costs (including a 100 percent increase for fringe benefits and overhead) for estimating the burden associated with the ICRs.
As indicated, employee hourly wage estimates have been adjusted by a factor
We are finalizing our proposal to allow State regulators to request a reduction, beginning for the 2020 benefit year, to risk adjustment transfers in the individual, small group or merged markets. We are finalizing the requirement for any State requesting this reduction to otherwise applicable transfers to submit its request with the supporting evidence and analysis to HHS identifying the State-specific factors that warrant the adjustment to more precisely account for the differences in actuarial risk in the State's individual, small group or merged market. Additionally, the State must submit supporting evidence and analysis demonstrating the reduction percentage requested is appropriate. This evidence and analysis justifying the percentage requested must either demonstrate the set of factors and the percentage by which those factors warrant an adjustment to more precisely account for the differences in actuarial risk in the State's individual, small group or merged market compared to the national norm, or it must demonstrate the requested reduction in risk adjustment payments would be so small for issuers who would receive risk adjustment payments, that the reduction would have a
We finalize that, beginning with 2017 benefit year risk adjustment data validation, issuers with 500 billable member months or fewer Statewide that elect to establish and submit data to an EDGE server will not be subject to the requirement to hire an initial validation auditor or submit initial validation audit results. We note that, beginning with 2018 benefit year risk adjustment data validation, these issuers will not be subject to random sampling under the materiality threshold discussed below, and will continue to not be subject to the requirement to hire an initial validation auditor or submit initial validation audit results. As 2016 benefit year risk adjustment data validation will be another pilot year, we are also finalizing the postponement of the application of the materiality threshold to the 2018 benefit year. Under this policy, all issuers of risk adjustment covered plans will be required to conduct an initial validation audit for the 2017 benefit year risk adjustment data validation, other than issuers with 500 billable member months or fewer Statewide as discussed above. Beginning with the 2018 benefit year, issuers below the $15 million premium materiality threshold will not be
HHS estimates that not requiring issuers that have 500 or fewer billable member months Statewide to conduct an initial validation audit beginning in the 2017 benefit year will exempt 50 issuers from an initial validation audit and reduce administrative costs for each issuer by 828 hours with an estimated cost reduction on average of up to $100,000. The total burden reduction for all 50 issuers will be 41,400 hours with an associated reduction in cost of $3,520,000. The postponement of the effectiveness of the materiality threshold to the 2018 benefit year will not impact issuer burden relative to previous estimates for the risk adjustment data validation program included in the 2014 and 2015 Payment Notices, particularly given that the program has been converted to a pilot for the first 2 years of operation. We are revising the current information collection approved under OMB control number 0938-1155: Standards Related to Reinsurance, Risk Corridors, Risk Adjustment, and Payment Appeals, to account for this reduction in burden.
For risk adjustment data validation, HHS requires issuers to document mental and behavioral health records included in audit sampling. Without the necessary mental and behavioral health information for each sample, the diagnosis code for an applicable enrollee cannot be validated and, therefore, it would be rejected during risk adjustment data validation.
Because providers may be prevented by some State privacy laws from furnishing a full mental health or behavioral health record, we are amending § 153.630(b)(6) to allow issuers an additional avenue to achieve compliance with data validation requirements by permitting the submission of mental or behavioral health assessments for risk adjustment data validation in the event that a provider is subject to State privacy laws that prohibit the provider from providing HHS with a complete mental or behavioral health record. For risk adjustment data validation purposes, to the extent permissible under applicable Federal and State privacy laws, an assessment should contain: (1) The enrollee's name; (2) sex; (3) date of birth; (4) current status of all mental or behavioral health diagnoses; and (5) dates of service. To submit a mental or behavioral health assessment, an issuer must ensure that it is accompanied by an attestation from the provider that applicable State privacy laws prevent him or her from providing the complete mental or behavioral health record.
HHS expects that this provision may affect 10 percent of issuers or approximately 70 issuers in States with stricter privacy laws on medical records. Based on our experience with the first pilot year risk adjustment data validation audits, we estimate that approximately 40 enrollees in any initial validation audit sample of 200 enrollees could be affected. Since providers routinely prepare mental or behavioral health assessments to validate diagnoses, we believe the slight additional burden is the time it would take to seek patient consent to provide the assessment, in States that require such permission, to review and edit the preexisting assessment for each medical record to include the data elements specified in § 153.630(b)(6), and to attest that relevant State privacy laws prohibit him or her from providing the complete mental or behavioral health record.
We estimate it will take a medical records technician (at an hourly rate of $39.86) 15 minutes to obtain consent from each patient, or approximately 10 burden hours at an estimated cost of $399 per issuer. In addition, we estimate a qualified licensed provider (psychiatrist, at an hourly rate of $192.52) will need 45 minutes to prepare an abbreviated assessment and sign an attestation, for a total of $144 per enrollee, or $5,776 per issuer. Therefore, for 40 patients, the total burden per issuer for the provider to obtain consent from each patient and prepare an abbreviated assessment and signed attestation will be 40 hours and approximately $6,174. The aggregated burden for the estimated 70 affected issuers will be 2,800 hours and approximately $432,194. We are revising the current information collection approved under OMB Control Number 0938-1155: Standards Related to Reinsurance, Risk Corridors, Risk Adjustment, and Payment Appeals, to account for this additional burden.
We are finalizing the proposal to exempt student health insurance coverage as defined in § 147.145 from the Federal rate review requirements. Because we will no longer be reviewing the reasonableness of rate increases for student health insurance coverage, we expect to collect less information for the 2019 plan or policy year than collected for previous years. This will reduce burden related to the submission and review for issuers and States. We estimate that 75 student health insurance issuers will no longer be required to submit rate increases to HHS. We estimate that each rate review submission takes 11 hours for an actuary (at a rate of $109.74 per hour) to prepare, and that each issuer will submit an average of 2.5 plans, at an estimated annual cost of $3,018, resulting in a total reduction in the annual burden to issuers of approximately 2,063 hours and an associated reduction in cost of approximately $226,339. We estimate that States will no longer submit rate increases for 188 student health insurance plans to HHS. We estimate a reduction in burden to States of one hour per plan for an actuary (at a rate of $80.82 per hour) to prepare and electronically submit the appropriate materials, for a total reduction in burden of approximately 188 hours annually with an associated cost reduction of approximately $15,194. We will revise our current burden estimate approved under OMB control number 0938-1141: Rate Increase Disclosure and Review Reporting Requirements, to reflect the reduced burden on States and issuers.
We are finalizing our proposal to establish a 15 percent Federal default threshold for reasonableness review. We expect this to reduce burden for issuers because Part II of the Rate Filing Justification (Consumer Justification Narrative) is only required for increases that meet or exceed the threshold. In the 2019 plan year, we estimate that the number of written justifications that will be submitted will decrease by approximately 125 submissions. That estimate is based on data from the 2018 plan year. We reached this estimate by counting the number of submissions
We estimate that each written justification will require 1.5 hours for an actuary (at a cost of $109.74 per hour) to prepare and electronically transmit the documentation. Therefore, the annual burden for issuers will be reduced by 187.5 hours, with an estimated annual savings of $20,576.
As stated above, we estimate 125 fewer submissions with rate increases subject to review. Assuming that States adopt the Federal default threshold, we expect the number of State reviews will decrease by 123 submissions.
We will revise our current burden estimate approved under OMB control number 0938-1141: Rate Increase Disclosure and Review Reporting Requirements, to reflect the reduced burden on issuers.
We are finalizing the proposals granting additional flexibilities, effective on the effective date of this rule and applicable for plan years beginning on or after January 1, 2018, to SHOPs, to qualified employers and employees enrolling in SHOP plans, and to participating QHP issuers and SHOP-registered agents and brokers in how they interact with a SHOP. Under the proposals being finalized throughout this document, SHOPs will no longer be required to provide enrollment, premium aggregation functions, and online enrollment functionality through a SHOP website, and the FF-SHOPs and SBE-FPs for SHOP, will no longer continue to perform these functions. Instead, small groups will enroll in a SHOP plan through a SHOP-registered agent or broker or through a participating QHP issuer participating in a SHOP. FF-SHOPs will follow the approach as outlined in this final rule. SBEs will have the flexibility to operate their SHOP in a way that meets the needs of their State and complies with the regulatory flexibilities outlined herein.
Under the proposals being finalized in this rule several pieces of information currently being collected by a SHOP may no longer be collected by a SHOP, or, the way in which the information is collected may change. For example, employers, employees, and agents and brokers may be required to provide the information currently collected by a SHOP to an issuer for the purposes of enrollment in a SHOP plan. A SHOP, like the FF-SHOPs and SBE-FPs for SHOP, however, will not be the entity collecting the information and the Federal government thus will experience a reduction in burden. Under the new regulatory flexibilities being finalized and described throughout this rule, employers and employees will no longer be required to visit a SHOP website in order to enroll in a SHOP plan and a SHOP will no longer be required to have the capability or the need to collect enrollment information. Employers will however, be required to apply to the SHOP to obtain an eligibility determination, as described in § 155.710, at which point the employer will be requested to provide: (1) Employer name and address of employer's locations; (2) Information sufficient to confirm the employer is a small employer; (3) Employer Identification Number (EIN); and (4) Information sufficient to confirm that the employer is offering, at a minimum, all full-time employees coverage in a QHP through a SHOP. Under current regulations, the employer provides, and a SHOP collects, this information as part of enrolling in a SHOP QHP through a SHOP. HHS previously estimated that an employer needed two hours to complete the eligibility determination when it was included as part of enrolling in a SHOP QHP and that 6,000 employers will complete an application annually to determine their eligibility through a SHOP website. Based on these criteria, HHS estimated that the total annual burden for 6,000 employers was 12,000 hours, with a total annual cost of $561,240 to complete the SHOP application and eligibility determination process. With the new regulatory flexibilities being granted to SHOPs, HHS estimates that for each employer, an administrative assistant will need less than 5 minutes (at rate of $34.76 per hour) to complete the required eligibility determination. Under the new flexibilities, employers will also no longer be required to create an account on an FF-SHOP website in order to complete the eligibility determination or enroll in a SHOP QHP. Therefore, HHS estimates that it will cost an employer approximately $3 to complete an eligibility determination. Assuming that 6,000 employers will complete an eligibility determination, HHS estimates that the total annual burden will be approximately 500 hours, with an estimated total cost of $17,400. This will result in a net burden reduction of 11,500 hours and a net cost reduction of approximately $543,840 annually. Under § 157.206(e)(1), employers will be responsible for submitting a new eligibility determination or, submitting a notice of withdrawal, in the event the group experienced a change that will impact the group's eligibility to participate in a SHOP. Under § 157.206(e)(2), employers will also be required to notify their QHP issuer(s) of a determination of ineligibility. Finally, employers will also, under § 157.206(e)(3) be required to notify their issuers of their intent to no longer participate in a SHOP. While these proposals will require employers to communicate with issuers in ways they do not under current SHOP enrollment practices, HHS does not anticipate that these practices will increase the burden on employers as they, under current practice, must notify the SHOP of changes in eligibility and termination. Although the policy in § 155.716 imposes an information collection requirement, the information that will be collected is no different from what is already approved under OMB control number 0938-1193: Data Collection to Support Eligibility Determinations and Enrollment for Small Businesses in the Small Business Health Options, and therefore we are not revising the information collection at this time.
Employees, under § 155.716 will not experience an increase in burden. Under the policies described throughout this final rule, employees will no longer be required to visit an FF-SHOP website to create an account, or, for any application or enrollment purpose, but they may need to provide similar information to an agent or broker or issuer as a condition of enrollment into a SHOP QHP. HHS previously estimated that 60,000 employees will complete an application annually, each spending approximately one hour to complete an online application through an FF-SHOP website. The estimated annual burden was 60,000 hours with an annual cost of $1,025,400. With the finalized flexibilities to a SHOP as described in this rule, HHS predicts that the burden on employees to complete an online application will shift as no application
Sections 155.705, 155.715, 155.720, 155.725, require SHOPs to generate certain notices. These notices may include: (1) Notices of annual election periods; (2) notices to employers of employee coverage terminations; (3) notices of application inconsistencies; (4) notices of appeal rights and instructions; (5) notices of employee and employer eligibility; (6) notices of employer withdrawal; (7) (in FF-SHOPs only) notices to employees if a dependent turns 26 and is no longer eligible for dependent coverage; (8) billing invoices, successful and unsuccessful payment confirmation notices; and (9) past due payment notices. In prior guidance, HHS previously estimated costs for paper notices in an FF-SHOP. In that estimate, HHS assumed that 80 percent of enrollees requested electronic notices and 20 percent of enrollees requested paper notices. HHS estimated that mailing paper notices costs a SHOP Exchange $0.53 per notice. HHS determined that SHOPs sent approximately 48,000 notices to enrollees when—(1) A dependent became ineligible to remain on the plan; (2) successful payment was processed; and (3) a payment was unsuccessful in the last year. Assuming that 20 percent of enrollees will opt to receive paper notices instead of electronic notifications, HHS estimated that approximately 9,600 notices will be sent, costing FF-SHOPs approximately $5,088. Under the flexibilities being finalized, SHOPs will only be required to send notices of employer eligibility and appeals. This cost will not directly be transferred to issuers as issuers may already be required to send such notices per other applicable State and Federal law. This collection is currently approved under OMB control number 0938-1207: Essential Health Benefits in Alternative Benefit Plans, Eligibility Notices, Fair Hearing and Appeal Processes, and Premiums and Cost Sharing; Exchanges: Eligibility and Enrollment. Issuers will be required to collect premiums, as premium aggregation functions will no longer be provided by the SHOPs that take advantage of the new flexibilities. HHS does not anticipate a significant increase of issuers' burden in this scenario, as it is not significantly different from their current operating practices.
In the rule, we are finalizing at § 156.111(e) to revise the collection of data for selection of States' EHB-benchmark plans for plan years beginning on or after January 1, 2020. This proposal includes the documentation that States would be required to submit if the State chooses to change its EHB-benchmark plan. For this purpose, we are amending the currently approved information collection (OMB Control Number: 0938-1174) to reflect the finalized policy in this rule. Because § 156.111(e) is replacing the current data collection requirements at § 156.120, we are updating the current EHB-benchmark plan selection to account for the new regulation and any associated burden with this requirement that falls on those States that choose to reselect their EHB-benchmark plan. Under the previous benchmark plan selection policy, 29 States selected one of the 10 base-benchmark plan options and 22 States defaulted. The previous benchmark plan policy did not allow for States to make an annual selection. The regulation allows States the opportunity to modify their EHB-benchmark plans annually. The regulation also does not require the State to respond to this ICR for any year for which they did not change their EHB-benchmark plan. As such, for purposes of the new EHB-benchmark plan selection options finalized in this rule, we estimate that 10 States would choose to make a change to their EHB-benchmark plans in any given year (total of 30 States over 3 years within the authorization of this ICR) and respond to this ICR.
To select a new EHB-benchmark plan, we require at § 156.111(e)(1) that the State provide confirmation that the State's EHB-benchmark plan selection complies with certain requirements, including those under § 156.111(a), (b), and (c). To complete this requirement, we estimate that a financial examiner will require 4 hours (at a rate of $66.04 per hour) to fill out, review, and transmit a complete and accurate document. We estimate that it costs each State $264 to meet this reporting requirement, with a total annual burden for all 10 States of 40 hours and an associated total cost of $2,642.
Second, we require at § 156.111(e)(2) that the State submit an actuarial certification and associated actuarial report of the methods and assumptions when selecting options under § 156.111(a). Specifically, we are finalizing at § 156.111(b)(2)(i) and (ii) that a State's EHB- benchmark plan must provide a scope of benefits equal to, or greater than, to the extent any supplementation is required to provide coverage within each EHB category at § 156.110(a), the scope of benefits provided under a typical employer plan, and that the State's EHB-benchmark plan must not exceed the generosity of the most generous among a set of comparison plans. The actuarial certification that is being collected under this ICR is required to include an actuarial report that complies with generally accepted actuarial principles and methodologies. This estimate includes complying with all applicable ASOPs. For example, ASOP 41 on actuarial communications includes disclosure requirements, including those that apply to the disclosure of information on the methods and assumptions being used and ASOP 50 contains information on determining MV and AV. In accordance with ASOP 41, we would expect that the actuarial report is based on a data analysis that is reflective of an appropriate population. The actuarial certification for this requirement is provided in a template and includes an attestation that the standard actuarial practices have been followed or that exceptions have been noted. The signing actuary is required to be a Member of the American Academy of Actuaries.
We estimate that an actuary, who is a member of the American Academy of Actuaries, requires 18 hours (at a rate of $80.82 per hour) on average for § 156.111(e)(2). This includes the certification and associated actuarial report from an actuary to affirm, in accordance with generally accepted actuarial principles and methodologies, that the State's EHB-benchmark plan provides a scope of benefits that is equal to, or greater than, to the extent any supplementation is required to provide coverage within an EHB category at § 156.110(a), the scope of benefits provided under a typical employer plan, and that the State's EHB-benchmark plan definition does not exceed the generosity of the most generous among the set of comparison plans. We are also finalizing a document entitled
For these calculations, the actuary needs to conduct the appropriate calculations to create and review an actuarial certification and associated actuarial report, including minimal time required for recordkeeping. The precise level of effort for the actuarial certification and associated actuarial report under § 156.111(e)(2) will likely vary depending on the State's approach to its EHB-benchmark plan and this certification requirement. For example, as described in the
We increased the estimated burden hours from 16 hours to 18 hours for the actuary to complete the actuarial certification and associated report in recognition of the extension of the generosity standard and in recognition that the definition of typical employer plan may require the actuary to determine whether the typical employer plan meets MV requirements. We are also increasing the estimated number of States that need to respond to this section of the ICR from 7 to 10 since the typical employer plan standard and the generosity standard applies to all State's EHB-benchmark plan options at § 156.111(a). We estimate that each State incurs a burden of 19 hours with an associated cost of $1,520.80 with a total annual burden for 10 States of 190 hours at associated total cost of $15,208. We did not receive comments on this specific estimate.
Third, we require at § 156.111(e)(3) each State to submit its proposed EHB-benchmark plan documents. The level of effort associated with this requirement will depend on the State's selection of the EHB-benchmark plan options under the regulation at § 156.111(a). However, for the purposes of this estimate, we estimate that it requires a financial examiner (at a rate of $66.04 per hour) 12 hours on average to create, review, and electronically transmit the State's EHB-benchmark plan document that accurately reflects the benefits and limitations, including medical management requirements and a schedule of benefits, resulting in a burden of 12 hours and an associated cost of $792, with a total annual burden for all 10 States of 120 hours and an associated cost of $7,925. The burden for producing these documents is significantly higher than previous estimates because the previous data collection generally only required the State (or issuer) to transmit the selected benchmark plan document. In contrast, in some cases, the § 156.111(a) may result in the State needing to create a completely new document or significantly modify the current document to represent the plan document. Additionally, this estimate of 12 hours also includes the burden necessary for a State selecting the option at § 156.111(e)(3) where the State is required to submit a formulary drug list for the State's EHB-benchmark plan in a format and manner specified by HHS. Specifically, the burden for the State selecting this option is also likely to vary as the State could use an existing formulary drug list or create its own formulary drug list separately for this purpose. To collect the formulary drug list, the State is required to use the template provided by HHS and submit the formulary drug list as a list of RxNorm Concept Unique Identifiers (RxCUIs).
Section 156.111(e)(4) requires the State to submit the documentation necessary to operationalize the State's EHB-benchmark plan. This reporting requirement includes the EHB summary file that is currently posted on CCIIO's website, used as part of the QHP certification process, and integrated into HHS's IT Build systems that feed into the data that is displayed on
Under the previous policy, the burden estimates 226 respondents per year, for a total yearly burden total of 165 annual burden hours and a total annual associated cost of $8,094 to meet these reporting requirements. Under the new policy related to EHB, we estimate that the total number of respondents will be 10 per year, for a total yearly burden of 470 hours and an associated cost of $33,699 to meet these reporting requirements. The estimated burden associated with the changes represents an increase of 305 hours (increase from 165 hours to 470 hours) and an annual costs increase of $25,605 (from $8,094 to $33,699) over the previously approved information collection (OMB Control Number: 0938-1174).
As part of the update to this OMB control number: 0938-1174, we also sought comment on requirements for SADPs to submit voluntary reporting. This collection includes data on whether the issuer intends to offer SADP coverage, the anticipated Exchange market in which coverage will be offered, and the State and service area in which the issuer offers coverage. The burden associated with meeting this requirement includes the time and effort needed by the issuer to report on whether it intends to offer SADP coverage. We estimate that it will take one half hour for a health insurance issuer to meet this reporting requirement. We estimate that approximately 175 issuers will respond to this data collection. Therefore, we anticipate that the reporting
Lastly, as part of the update to this OMB control number: 0938-1174, we are adding an information collection request to this ICR to account for the finalized policy at § 156.115(b)(2)(ii) that allows the State the option to notify HHS that the State will allow substitution between EHB categories of benefits, beginning with the 2020 plan year. Specifically, § 156.115(b)(2)(ii) will allow issuers to substitute benefits only when the State in which the plan will be offered permits such substitution and notifies HHS of its decision to allow substitution between categories. We anticipate that States will notify HHS through the same means the States will notify HHS of an updated EHB-benchmark plan selection under § 156.111 and we intend to provide a preformatted response for States to use to provide the notification to HHS. To provide notification under § 156.115(b)(2)(ii), we estimate that it will require a financial examiner
We are amending § 158.221 to allow issuers the option to report quality improvement activity expenses as a single fixed percentage of premium amount beginning with the 2017 MLR reporting year (that is, for reports filed by July 31, 2018), and making conforming amendments to § 158.170. We do not anticipate that implementing this provision will require significant changes to the MLR annual reporting form and the associated burden. In addition, while we are not making changes to § 158.162, pursuant to public comments, we intend to make a change to the MLR annual reporting form in order to collect the information on issuers' employment taxes separately from other taxes. We do not anticipate that implementing this provision will significantly change the reporting burden either, as issuers already include this information on the reporting form, and would simply have to include it on a different line on the form. The burden related to this collection is currently approved under OMB control number 0938-1164; Medical Loss Ratio Annual Reports, MLR Notices, and Recordkeeping Requirements.
We are also amending subpart C to modify the data and narratives which a State must submit as part of the State's request for an adjustment to the MLR standard in the individual market for that State. There is no standardized application form associated with a State's request, but each request must contain certain data elements in order to receive consideration by the Secretary, which are described in §§ 158.320-158.323, 158.340, 158.346, and 158.350. The burden related to the proposed requirements was previously approved under OMB control number 0938-1114, Medical Loss Ratio (IFR) Information Collection Requirements and Supporting Regulations; the approval expired in 2014. We intend to reinstate this information collection, with modifications to reflect our finalized revisions to subpart C of part 158. The proposed rule (82 FR 51052), published on November 2, 2017, served as the 60-day notice to afford the public an opportunity to comment on this collection of information requirement.
We are eliminating collection of the following information from a State requesting an adjustment: The State MLR standard and formula for assessing compliance (§ 158.321(a)), its market withdrawal requirements (§ 158.321(b)), and the mechanisms available to the State to provide consumers with options for alternate coverage (§ 158.321(c)); as well as the net underwriting profit for the total business in the State and the after-tax profit and profit margin for the individual market and total business in the State (§ 158.321(d)(2)(vii)), and the estimated rebate (§ 158.321(d)(2)(v)) of each issuer with at least 1,000 enrollees in the State. We expect these amendments to reduce the burden on States seeking an adjustment. We are also replacing the requirement that a State requesting an adjustment must submit enrollment and premium data for every individual market issuer at the product level (§ 158.321(d)(1)) and the reported and estimated MLRs (§ 158.321(d)(2)(ii) and (iii)) for issuers with at least 1,000 enrollees, with total enrollment (life-years and covered lives), premium, and total incurred claims for only active individual market issuers, separately for five types of individual market coverage: On-Exchange plans, off-Exchange plans, grandfathered health plans as defined in § 147.140, coverage that meets the criteria for transitional policies outlined in applicable guidance, and non-grandfathered single risk pool coverage. States will not be required to provide information on student health insurance coverage as defined in § 147.145 or excepted benefits as defined in § 148.220. We expect these amendments to result in a net reduction in burden on States seeking an adjustment. We will continue to collect data on total agents' and broker's commission expenses and net underwriting gain (proposed to be redesignated from § 158.321(d)(2)(iv) and (vi) to § 158.321(a)(3) and (4), respectively) for only active individual market issuers, but separately for the five types of coverage described above. We will also continue to collect information on risk-based capital levels (proposed to be redesignated from § 158.321(d)(2)(viii) to § 158.321(a)(5)) at the issuer level. While the amendments will require more breakdown of the data than § 158.321 previously required, in most States there are more issuers with at least 1,000 enrollees than there are active issuers in the individual market, and consequently we expect that these amendments will have no net impact on the burden. Additionally, we are updating § 158.321(d)(2)(ix) to collect more specific information on issuer notices to the State of changes to participation in the State's individual market, rather than focusing exclusively on notices to exit the individual market. We do not expect this amendment to have an appreciable impact on the burden. We are further eliminating the requirement that a State requesting an adjustment provide information explaining and justifying how its proposed adjustment was determined and estimating rebates that would be paid with and without an adjustment (§ 158.322(a), (c), and (d)); as well as replacing what information a State must provide pursuant to § 158.322(b) with a requirement to explain how the adjustment would help stabilize the State's individual market. We expect these amendments to reduce the burden. Lastly, we have updated what information a State must submit with a
Based on preliminary data analysis and previous State requests for adjustments, we estimate that approximately 22 States will submit applications in the first year. We estimate that it will take approximately 140 hours on average for each State to complete the application, including gathering and analyzing data, synthesizing information, and developing a proposal for an adjusted MLR standard. Specifically, we assume that the application will take a financial analyst approximately 96 hours (at a rate of $68.78 per hour), an actuary 6 hours (at a rate of $80.82 per hour), a financial manager 10 hours (at a rate of $91.66 per hour), a lawyer 24 hours (at a rate of $89.74 per hour), and the insurance commissioner 4 hours (at a rate of $116.90 per hour) to assemble and review the various components of the application, resulting in a total burden for each State of 140 hours with an associated cost of $10,626 per response, representing an estimated total burden reduction of 45 hours per response. The documents will be submitted electronically at minimal cost. We estimate that the total burden for 22 States to submit a request for an adjustment to the individual market MLR standard will be 3,080 hours with an associated cost of approximately $233,767, with an estimated net total reduction in burden of 620 hours. We recognize that this burden may vary between States, as some States may have better access to the required application information elements, while other States may have to seek some of the required information from health insurance issuers in their States, which could increase their burden. Some States may, if providing the requested information is an undue burden, ask the Secretary to consider their application without some of the information elements. We received a few comments that generally questioned whether the burden on States related to the information collection requirements prior to the finalized amendments may have been overstated, but that did not specify the basis for such concerns and did not relate to the estimates for the revised information collection requirements. We also received one comment that agreed with the estimates for the revised information collection.
We have submitted a copy of this final rule to OMB for its review of the rule's information collection and recordkeeping requirements. These requirements are not effective until they have been approved by the OMB.
To obtain copies of the supporting statement and any related forms for the final collections discussed above, please visit CMS's website at
We invite public comments on these information collection requirements. If you wish to comment, please submit your comments electronically as specified in the
ICR-related comments are due May 17, 2018.
This rule finalizes standards related to the risk adjustment program for the 2019 benefit year, as well as certain modifications that will promote State flexibility and control over their insurance markets, reduce burden on stakeholders, and protect consumers from increases in premiums due to issuer uncertainty. The Premium Stabilization Rule and previous Payment Notices provided detail on the implementation of the risk adjustment program, including the specific parameters applicable for the 2014, 2015, 2016, 2017, and 2018 benefit years. This rule finalizes additional standards related to EHBs; cost-sharing parameters; QHP certification; the Exchanges, including terminations, exemptions, eligibility and enrollment; AV for stand-alone dental plans; MEC; the rate review program; the medical loss ratio program; the Small Business Health Options Program; and FFE and SBE-FP user fees.
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 202 of the Unfunded Mandates Reform Act of 1995 (March 22, 1995, Pub. L. 104-4), Executive Order 13132 on Federalism (August 4, 1999), and the Congressional Review Act (5 U.S.C. 804(2)), and Executive Order 13771 on Reducing Regulation and Controlling Regulatory Costs (January 30, 2017).
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
OMB has determined that this final rule is “economically significant” within the meaning of section 3(f)(1) of Executive Order 12866, because it is likely to have an annual effect of $100 million in any 1 year. Accordingly, we have prepared an RIA that presents the costs and benefits of this final rule.
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), and a “significant” regulatory action is subject to review by OMB. HHS has concluded that this rule is likely to have economic impacts of $100 million or more in at least 1 year, and therefore, meets the definition of “significant rule” under Executive Order 12866. Therefore, HHS has provided an assessment of the potential costs, benefits, and transfers associated with this rule.
The provisions in this final rule aim to improve the health and stability of the Exchanges, and to provide States with additional flexibility and control over their insurance markets. They will reduce regulatory burden, and reduce administrative costs for issuers and States, and will lower net premiums for consumers. Through the reduction in financial uncertainty for issuers and increased affordability for consumers, these provisions are expected to increase access to affordable health coverage. Although there is some uncertainty regarding the net effect on enrollment and premiums, we anticipate that the provisions of this final rule will help further HHS's goal of ensuring that all consumers have access to quality, affordable health care; that markets are stable; and that Exchanges operate smoothly.
Although it is difficult to discuss the wide-ranging effects of these provisions in isolation, the overarching goal of the premium stabilization, market standards, and Exchange-related provisions and policies in the PPACA is to make affordable health insurance available to individuals who do not have access to affordable employer-sponsored coverage or government-sponsored coverage. The provisions within this final rule are integral to the goal of expanding coverage. For example, the risk adjustment program helps prevent risk selection and decrease the risk of financial loss that health insurance issuers might otherwise expect in 2019.
HHS anticipates that the provisions of this final rule will help further the Department's goal of ensuring that all consumers have access to quality and affordable health care and are able to make informed choices, that Exchanges operate smoothly, that the risk adjustment program works as intended, and that States have more control and flexibility over EHBs, QHP certification and the operation and establishment of Exchanges. Affected entities such as QHP issuers will incur costs to comply with the proposed provisions, for example, those related to the functions of a SHOP; including calculating the minimum participation rate at the employer level and processing SHOP enrollments for employers and employees; and States will incur costs if they select a new EHB-benchmark plan under the new regulations. In accordance with Executive Order 12866, HHS believes that the benefits of this regulatory action justify the costs.
In accordance with OMB Circular A-4, Table 13 depicts an accounting statement summarizing HHS's assessment of the benefits, costs, and transfers associated with this regulatory action.
This final rule implements standards for programs that will have numerous effects, including providing consumers with access to affordable health insurance coverage, reducing the impact of adverse selection, and stabilizing premiums in the individual and small group health insurance markets and in an Exchange. We are unable to quantify certain benefits of this final rule—such as any reduction in burden related to changes in the timing related to State deadlines for submission of rate filings from issuers that only offer non-QHPs; increased flexibility for Exchanges related to the removal of certain requirements for Navigator programs and non-Navigator assistance personnel entities; increased access to the direct enrollment pathway stemming from permitting a third-party entity to conduct operational readiness reviews for agents, brokers, and issuers; benefits to Exchanges related to proposed simplifications of verification requirements; benefits to consumers, issuers or Exchanges related to the changes related to the special enrollment periods; increased flexibility for States relating to the proposals regarding the SHOP enrollment process; and potential decreases in premiums to consumers related to removing actuarial value standards for SADPs—and certain costs—such as the costs incurred by small employers, agents and brokers, and potential increases in out-of-pocket costs to consumers related to removing actuarial value standards for SADPs; and costs to issuers, brokers, agents, and employers related to changes in SHOP enrollment procedures. The effects in Table 13 reflect qualitative impacts and estimated direct monetary costs and transfers resulting from the provisions of this final rule for health insurance issuers. The annualized monetized costs described in Table 13 reflect direct administrative costs to health insurance issuers as a result of the finalized provisions, and include administrative costs associated with States requesting a reduction in risk adjustment transfers for the State's individual, small group or merged market, the reduction in costs relating to issuers and States having to no longer submit rate increases for student health insurance plans to HHS, and costs associated with States seeking an adjustment to the MLR standard in the State's individual market that are estimated in the Collection of Information section of this final rule. The annual monetized transfers described in Table 13 include costs associated with SBE-FP user fees, the risk adjustment user fee paid to HHS by issuers, and reductions in rebate payments from issuers to consumers related to QIA and MLR adjustments. We are finalizing a risk adjustment user fee to collect $1.80 per enrollee per year from risk adjustment issuers to operate the risk adjustment program on behalf of States, which we expect to cost
This RIA expands upon the impact analyses of previous rules and utilizes the Congressional Budget Office's (CBO) analysis of the PPACA's impact on Federal spending, revenue collection, and insurance enrollment. The PPACA transitional reinsurance program and temporary risk corridors program end after the benefit year 2016. Therefore, the costs associated with those programs are not included in Tables 14 or 15 for fiscal years 2019-2022. Table 14 summarizes the effects of the risk adjustment program on the Federal budget from fiscal years 2018 through 2022, with the additional, societal effects of this final rule discussed in this RIA. We do not expect the provisions of this final rule to significantly alter CBO's estimates of the budget impact of the premium stabilization programs that are described in Table 14. We note that transfers associated with the risk adjustment program were previously estimated in the Premium Stabilization Rule; therefore, to avoid double-counting, we do not include them in the accounting statement for this final rule (Table 13).
In addition to utilizing CBO projections, HHS conducted an internal analysis of the effects of its regulations on enrollment and premiums. Based on these internal analyses, we anticipate that the quantitative effects of the provisions proposed in this rule are consistent with our previous estimates in the 2018 Payment Notice for the impacts associated with the APTC, the premium stabilization programs, and FFE user fee requirements.
The risk adjustment program is a permanent program created by the PPACA that transfers funds from lower risk, non-grandfathered plans to higher risk, non-grandfathered plans in the individual and small group markets, inside and outside the Exchanges. We established standards for the administration of the risk adjustment program, in subparts D and G of part 153 in Title 45 of the CFR.
A State approved or conditionally approved by the Secretary to operate an Exchange may establish a risk adjustment program, or have HHS do so on its behalf. As described in the 2014 through 2018 Payment Notices, if HHS operates risk adjustment on behalf of a State, it will fund its risk adjustment program operations by assessing a risk adjustment user fee on issuers of risk adjustment covered plans. For the 2019 benefit year, we estimate that the total cost for HHS to operate the risk adjustment program on behalf of States for 2019 will be approximately $40 million, and that the risk adjustment user fee would be approximately $1.80 per enrollee per year. This user fee reflects costs to support the risk adjustment data validation process in 2019, lower costs related to risk adjustment issuer outreach and education and lower enrollment in risk adjustment covered QHPs, and includes administrative and personnel cost related to the risk adjustment program, resulting in a slightly higher user fee rate for 2019 than the 2018 benefit year rate.
We believe that the approach of blending the coefficients calculated from the 2016 benefit year enrollee-level EDGE data with 2014 and 2015 MarketScan® data finalized in this rule will provide stability within the risk adjustment program and minimize volatility in changes to risk scores from the 2018 benefit year to the 2019 benefit
We are finalizing the provision for States to request a reduction in risk adjustment transfers in the individual, small group or merged market. We expect this policy will reduce transfers proportional to the percent by which the States seek to reduce the transfers to account for State-specific market rules or relevant factors without the necessity for States to undertake operation of their own risk adjustment program. However, because the risk adjustment program is budget neutral, any State decision to request a reduction in the risk adjustment transfers will have no net impact on risk adjustment transfers.
We are finalizing several changes to the requirements for risk adjustment data validation that overall would reduce regulatory burden and costs for issuers of risk adjustment covered plans. HHS believes that adjusting issuers' risk adjustment risk scores only when an issuer's failure rate for a group of HCCs is statistically different from the weighted mean failure rate for that group of HCCs for all issuers that submitted initial validation audits will help market stability by increasing issuers' ability to predict risk adjustment transfers and liquidity needs. We anticipate that many issuers required to participate in risk adjustment data validation will not have their risk scores adjusted, based on our analysis of error rates in the Medicare risk adjustment data validation program.
We anticipate that the post-transfer adjustment of risk adjustment transfers for issuers that exited a State market will result in transfer adjustments for a small subset of issuers that previously would not have had their transfers adjusted, but HHS does not expect this policy to increase burden for these issuers, especially in light of the revised payment adjustments for error rates policy finalized in this rule.
HHS estimates that not requiring issuers that have 500 or fewer billable member months Statewide to conduct an initial validation audit beginning in the 2017 benefit year will reduce the administrative burden and costs on those issuers. The reduction in burden and costs related to this ICR has been discussed previously in the Collection of Information Requirements section.
Under the change to the sampling methodology finalized in this rule, issuers that were the sole issuer in a risk pool will still need to provide a sample for data validation, but the sample will not include enrollees from the risk pool where they were the sole issuer. Therefore, this change will not have a significant impact on costs or burden for affected issuers.
We are finalizing an amendment to § 153.630(b)(6) to state that a qualified provider licensed to diagnose mental illness that is prohibited by State privacy laws from furnishing a complete medical record for data validation may furnish a signed mental or behavioral health assessment that providers routinely prepare along with the required attestation. For risk adjustment data validation purposes, a mental or behavioral health assessment should, to the extent permissible under applicable State and Federal privacy laws, contain: (i) The enrollee's name; (ii) sex; (iii) date of birth; (iv) current status of all mental or behavioral health diagnoses; and (v) dates of service. The burden associated with this requirement has been discussed previously in the Collection of Information Requirements section.
We are finalizing an amendment to § 153.630(b)(9) to state that, if an issuer of a risk adjustment covered plan (1) fails to engage an initial validation auditor; (2) fails to submit the results of an initial validation audit to HHS; (3) engages in misconduct or substantial non-compliance with the risk adjustment data validation standards and requirements applicable to issuers of risk adjustment covered plans; or (4) intentionally or recklessly misrepresents or falsifies information that it furnishes to HHS, HHS may impose CMPs in accordance with the procedures set forth in § 156.805(b) through (e). Because risk adjustment data validation has thus far operated as a pilot program, we cannot estimate the number of issuers that will be subject to CMPs. However, we do not expect that a significant number of issuers will engage in the extreme misconduct required to warrant a CMP under this amended regulation.
We are amending § 154.103 to exclude student health insurance coverage effective on or after July 1, 2018 from the Federal rate review requirements. This will reduce burden related to rate review submission and review for issuers and States. In addition, providing States with more flexibility regarding timing of submission of rate filing justification from issuers that offer non-QHPs only, and reducing the advance notification requirement for rate increase announcements, will reduce regulatory burden for issuers and States. The reduction in burden and costs related to ICRs have been discussed previously in the Collection of Information Requirements section.
Raising the Federal default review threshold from 10 percent to 15 percent will reduce administrative burden for issuers and States while continuing to provide the Secretary and the States with the information necessary to effectively carry out their responsibilities to monitor rate increases inside and outside of Exchanges. As discussed previously in the Collection of Information Requirements section, issuer burden will decrease by an estimated $20,576 and the State burden will decrease by an estimated $519,674 annually. Given that only one rate filing subject to review over the last 4 years in the 10 to 15 percent rate increase range was determined to be unreasonable, we feel this is a reasonable tradeoff for the potential burden savings.
We are extending the applicability of the policies governing State-required benefits at § 155.170 to the policies finalized at § 156.111, which provide States with new options for selecting their EHB-benchmark plans beginning for the 2019 plan year. Specifically, under any of the three EHB-benchmark plan selection options, or if the State defaults to its current EHB-benchmark plan, the policies regarding State-required benefits will continue to apply. Because these policies continue to be in effect, we do not anticipate any additional burden on States or issuers.
We amended § 155.210(c)(2) to remove the requirements that each Exchange must have at least two Navigator entities and that one of these entities must be a community and consumer-focused nonprofit group. We also amended §§ 155.210(e)(7) and 155.215(h) to remove the requirements that Navigators and non-Navigator assistance personnel entities subject to those regulations maintain a physical presence in the Exchange service area. These amendments to § 155.210(c)(2) will reduce the burden on Exchanges to have at least two separate Navigator entities, and as a result, Exchanges may be able to reduce funding amounts while still meeting program requirements. Removing these requirements will help promote flexibility and autonomy for each Exchange to structure its Navigator program, and to award grant funding to the number and type of entities that will be most effective and efficient for that specific Exchange service area. To the
The final regulations replace the requirement that an HHS-approved third party perform audits of agents and brokers participating in direct enrollment and use their own internet website for QHP selection or to complete the Exchange eligibility application to instead permit an agent, broker or issuer to select a third-party entity that meets HHS requirements to conduct an annual operational readiness review prior to participating in direct enrollment. HHS anticipates this approach will reduce the regulatory burden on agents, brokers, and issuers participating in direct enrollment. HHS also anticipates these changes will reduce the burden on third-party auditors performing reviews under § 155.221, as those entities will no longer be required to obtain HHS approval to perform the reviews. Furthermore, we believe this policy will expand the available number of qualified third-party auditors by removing any time and operational restrictions imposed by the HHS pre-approval requirement, which will provide more flexibility to agents, brokers, or issuers as they complete operational readiness reviews. Additionally, we believe this will enable more agents, brokers and issuers to demonstrate operational readiness by reducing the burden on HHS for conducting reviews, expediting the ability of these entities to demonstrate readiness, and increasing the feasibility of approval for use of innovative pathways, thereby creating more opportunities for enrollment in QHP coverage for consumers, potentially increasing enrollment. HHS anticipates that some of the burden will be lessened by the fact that many agents, brokers, or issuers already have the established privacy and security controls, and may have existing relationships with auditors that could be leveraged for these reviews. We intend to provide additional technical details regarding compliance with the specific requirements under these rules in guidance in the future.
The requirement in § 155.305(f)(4)(ii) that the Exchange must send direct notification to the tax filer before denying eligibility for APTC to consumers who fail to file and reconcile went into effect in mid-January 2017; therefore, it did not impact operations for the 2017 open enrollment period, which was nearly over then. At that point in time, for the FFE, the household contacts for non-filers had been notified of their tax filer's non-compliance, and APTC had been discontinued at auto re-enrollment for those who did not file a Federal income tax return according to IRS data or inform the FFE that they had filed a Federal tax return and reconciled past APTC. Requiring the Exchange to deny APTC for failure to file and reconcile even in the absence of “direct notification . . . to the tax filer” is unlikely to add new burden since Exchanges have not yet implemented § 155.305(f)(4)(ii). We do not believe that Exchanges have built an FTI-compliant noticing infrastructure since the publication of the final rule establishing § 155.305(f)(4)(ii) that they will need to dismantle. However, removing § 155.305(f)(4)(ii) avoids significant costs for Exchanges that, as discussed above, no longer must build the infrastructure necessary to directly notify tax filers about their tax filing status while protecting FTI.
This rule amends § 155.320(c)(3)(iii) to create annual income data matching issues when applicants attest to income above 100 percent FPL, but trusted data sources show income below 100 percent FPL. We estimate that each SBE will incur one-time costs of approximately $450,000 to complete the necessary system changes to implement this policy. For 12 SBEs, the estimated total cost will be $5.4 million. This estimate does not take into account the ongoing operational expenses of processing data matching issues from this new requirement. Ongoing operational costs will be dependent on the Exchange's number of applicants with income inconsistencies and the threshold for setting a data matching issue.
This final rule will amend § 155.320(d)(4) to allow an Exchange to conduct an HHS-approved alternative process instead of sampling, as provided under paragraph (d)(4)(ii) through benefit year 2019. We believe this will relieve Exchanges from the burden of investing resources to conduct sampling when the FFEs' study of a sampling-like process found that this method of verification may not be cost-effective for some Exchanges at this time. We estimate the burden associated with sampling based in part on the alternative process used for the FFEs. HHS incurred approximately $750,000 in costs to design and operationalize this study and the study indicated that $353,581 of APTC was potentially incorrectly granted to individuals who inaccurately attested to their eligibility for or enrollment in a qualifying eligible employer-sponsored plan. We placed calls to employers to verify 15,125 cases but were only able to verify 1,948 cases. A large number of employers either could not be reached or were unable to verify a consumer's information, resulting in a verification rate of approximately 13 percent. The sample-size involved in the 2016 study did not represent a statistically significant sample of the target population and did not fulfill all regulatory requirements for sampling under paragraph (d)(4)(i) of § 155.320.
Taking additional costs into account—namely, the cost of sending notices to employees as required under paragraph (d)(4)(i)(A), the cost of building the infrastructure and implementing the first year of operationalizing this process, and the cost of expanding the number of cases to a statistically significant sample size of approximately 1 million cases—we estimate that the overall cost of implementing sampling would be approximately $8 million for the FFE, and between $2 million and $7 million for other Exchanges, depending on their enrollment volume and existing infrastructure. Therefore, we estimate that the average per-Exchange cost of implementing sampling that resembles the FFE's approach would be approximately $4.5 million for a total cost to SBEs of $54 million, when assuming 12 SBEs (operating in 11 States and the District of Columbia). This cost estimate does not, however, take into account the cost of notifying consumers when the information provided by their employer changes their eligibility determination described under paragraph (d)(4)(i)(E), the cost of providing employees consumer support that may be needed to understand notices and any change in eligibility, or the cost of ending those consumers' APTCs, when necessary. This estimate also does not account for the unique operating costs of each Exchange, the change to paragraph (d)(4) to allow
We believe this finalized change will lessen the financial and technical burdens on Exchanges under current regulation and allow Exchanges to conduct an alternative process to sampling under paragraph (d)(4) as approaches to sampling are refined and data bases are compiled over time. We sought comment on the reduction in burden associated with extending the option to allow Exchanges to fulfill verification requirements by conducting an HHS-approved alternative process to sampling through plan year 2019. We did not receive any comments on the reduction of burden associated with our proposed change.
We do not anticipate that the revisions to § 155.420 will create significant costs or burdens because several changes will simplify special enrollment period policy, and we also believe that they will generate some benefit in the form of added efficiency for Exchanges and improvements in some consumers' ability to maintain continuous coverage and understand their coverage options.
For example, the amendment to paragraph (d)(1)(iii) allows Exchanges to provide similar treatment to all women losing non-MEC pregnancy-related coverage, which enables a more streamlined special enrollment period eligibility process.
Additionally, the revisions in paragraph (b)(2)(i) align regulatory policy for special enrollment periods based on a court order with other similar special enrollment period types, and create operational efficiencies for Exchanges by streamlining effective date options across similar special enrollment periods with qualifying events related to gaining or becoming a dependent. For example, this revision to the regulation will enable the FFE to use a simpler online, automated application pathway for more special enrollment period-eligible consumers, meaning that fewer consumers will need to use a manual and costly casework process to use their special enrollment period. For limited cases when casework support is required, operations would also be simplified.
We acknowledge that this may not be the case for all Exchanges, and that an Exchange that has automated the option for consumers to elect that their coverage take effect on the first of the month after the date of their qualifying event may need to make updates so that consumers instead have the option to elect that their coverage take effect the first of the month after their date of plan selection. However, as discussed in the preamble, we believe that this burden will be limited, and mitigated due to the fact that offering a “first of the month” coverage effective date is optional for Exchanges, permitting a delayed rollout if necessary.
Additionally, amending paragraph (a)(5) to exempt qualified individuals from the prior coverage requirement that applies to certain special enrollment periods if they lived in a service area where no qualified health plan was available through the Exchange for 1 or more days during the 60 days preceding the qualifying event or during their most recent preceding enrollment period, as specified in §§ 155.410 and 155.420, may provide a pathway to coverage for a small group of individuals, and is not anticipated to impact the Exchange risk pool. It may generate burden on Exchanges due to required technical and operational updates should it become necessary to implement, but we anticipate that this burden will be mitigated by the small size of the affected group and by practices that are already in place in many Exchanges to verify eligibility for special enrollment periods. Additionally, Exchanges already exempt qualified individuals from the prior coverage requirement who may not previously have had access to QHP coverage through an Exchange, including those who were previously living in a foreign country or United States territory and Indians as defined by section 4 of the Indian Health Care Improvement Act. Therefore, we do not believe that adding an additional small population to this exemption will create additional costs or burdens.
Finally, because simplified special enrollment period eligibility policy provides improved pathways to continuous coverage for special enrollment period-eligible consumers, we anticipate that the provisions in this rule may result in less burden on call center representatives and caseworkers related to fewer questions about special enrollment periods due to gaining or becoming a dependent and loss of certain types of pregnancy-related coverage. We also anticipate that the revisions will reduce burden on consumers, have a positive effect on the risk pool, and not result in additional costs or burdens for issuers.
In addition, some States that operate Exchanges expressed concern that amending the plan option restrictions available to dependents who are newly enrolling in a plan with a QHP enrollee through a special enrollment period will increase the burden on States, which will be required to do a system build to align their systems with this change. We appreciate these concerns raised by States, but do not anticipate that this change will add significant additional burden on top of the system builds States are already doing. The intent of this policy change is to streamline the plan option rules for dependents who are newly enrolling in coverage with enrollees through a special enrollment period and so we anticipate that any additional burden incurred to amend Exchange system functionality will be offset by the efficiencies gained in streamlining Exchange eligibility rules.
Permitting all enrollee-initiated terminations to become effective on the date of enrollee request or a later date of their choosing, and removing the special termination effective date for newly eligible Medicaid/CHIP/BHP consumers streamlines termination effective dates for Exchanges and reduces complication and confusion among consumers and issuers. Exchanges and issuers were not expected to incur new costs by aligning these termination dates, as Exchanges and issuers are well acquainted with same-day termination transactions. However, we received comments from some SBEs that their systems would not allow for mid-month terminations. Therefore, we are not requiring the alignment of termination effective dates as proposed, but rather are providing Exchanges flexibility to choose whether to implement the changes that were proposed. Operationalizing the aligned termination dates may reduce system errors and related casework, as well as confusion for consumers, issuers, and caseworker and call center staff based on contradictory rules for different scenarios.
We do not anticipate that the amendment to § 155.605(d) will create additional costs or burdens. The amendment to § 155.605(d)(2)(iv) will enable the Exchanges to process the consumer's exemption from the individual shared responsibility provision due to lack of affordable coverage based on projected income, for those not eligible for employer-sponsored coverage, when there is no bronze plan available by allowing the Exchanges to process the consumer's
HHS is finalizing the proposal to grant additional flexibilities, for plan years beginning on or after January 1, 2018, to small employers enrolling in SHOP QHPs and to participating QHP issuers in how they interact with a SHOP. These changes will be effective as of the effective date of the final rule and the FF-SHOPs and SBE-FPs for SHOP will operate under the new enrollment approach. Under this final rule, several existing requirements on SHOPs will not apply for plan years beginning on or after January 1, 2018, allowing State Exchanges the flexibility to operate their SHOP in a way that makes sense for the small businesses in their State, with reduced limitations imposed by Federal regulation. The FF-SHOPs and SBE-FPs for SHOP will take advantage of the flexibility of the enrollment approach described through this final rule and operate in a leaner fashion. Under the approach being finalized, SHOPs are no longer required to enroll small groups in SHOP QHPs through a SHOP website. Instead, small employers will, in SHOPs that operate under this approach, enroll through a participating QHP issuer, or a SHOP-registered agent or broker.
HHS believes that the changes will reduce burden on participating QHP issuers, small employers, and agents and brokers for several reasons. Under the approach being finalized, for plan years beginning on or after January 1, 2018, effective on the effective date of this rule, participating QHP issuers will, in SHOPs that operate under the new flexibilities like the FF-SHOPs and SBE-FPs for SHOP, enroll small groups through their existing enrollment channels—utilizing their existing technologies and processes. Small groups enrolled in SHOP QHPs for plan years before January 1, 2018 will not be affected by the proposed changes to enrollment through a SHOP until they are due to renew in a SHOP QHP for the 2018 plan year. While some additional requirements will be imposed onto issuers, HHS anticipates that any additional burden on issuers as a result of the changes in this rule will be negated in an ultimate net reduction in burden as many Federal regulations are being removed and any additional requirements onto issuers mainly consist of practices they currently perform in the private market.
In the 2018 Payment Notice, HHS finalized the removal of a participation provision that had required certain QHP issuers to participate in an FF-SHOP in order to participate in an FFE. As a result, there has been a significant decrease in the number of issuers in the FF-SHOPs in the 2018 plan year and therefore, HHS also expects fewer enrollments in the FF-SHOPs for plan year 2018. As of January 1, 2017, approximately 7,554 employer groups were enrolled in the FF-SHOPs, covering 38,749 lives. With the anticipated significant decreases in QHP issuer participation for enrollment beginning in 2018, it is not cost effective for the Federal government to continue to maintain certain FF-SHOP functionalities, collect significantly reduced user fees on a monthly basis, maintain the technologies required to maintain an FF-SHOP website and payment platform, generate enrollment and payment transaction files, and perform enrollment reconciliation.
Under the approach being finalized in this rule, issuers will still be subject to their State requirements, and HHS will minimize Federal requirements related to SHOP plans (that is, notice requirements, etc.) for plan years beginning on or after January 1, 2018. For example, issuers are often required by State law to generate enrollment and payment notices, and will continue to generate any State-required notices under the new SHOP enrollment approach. Under the proposed approach, the FF-SHOPs and SBE-FPs for SHOP will no longer generate enrollment notices, but the notice requirements for the FF-SHOPs and SBE-FPs for SHOP will not necessarily be transferred directly to participating QHP issuers. HHS can imagine a scenario where an issuer might generate an additional notice to a SHOP consumer that they are not required by Federal law to send, but may be required by State law, to send.
Issuers will still be required to accept enrollment from employers that offer their employees a choice of plans. HHS can foresee a circumstance where an employer offers its employees a choice of plans, across plan categories, and where the employees choose to enroll in plans offered by multiple issuers. In this circumstance, it will also be possible that an issuer will receive one application for enrollment from a group. Under the approach to SHOP enrollment being finalized, the issuer will be required to accept that single enrollment so long as the employer's group has met the minimum participation rate for their State, or is enrolling between November 15 and December 15, when the minimum participation rate rules do not apply. With the decrease in issuer participation in the SHOPs beginning in plan year 2018, HHS believes that a circumstance, similar to the one discussed above may occur. In the absence of premium aggregation functions, issuers, under the approach being finalized will be working directly with an employer, or their appointed SHOP-registered agent or broker for matters of enrollment and premium billing and payment. Under the new regulations, effective as of the effective date of this rule, issuers will be required to enroll consumers into plans, even if only one employee of a group wants to enroll. Further, issuers will also be required to process enrollments into SHOP QHPs, and, handle appeals (other than appeals related to employer eligibility), administer special enrollment periods and terminations. Issuers will still be subject to the market wide effective dates outlined in § 147.104(b)(1)(i)(C). While HHS believes that issuers currently perform the majority of these tasks, issuers may experience an increase in burden as it relates to the volume of consumers enrolling in their SHOP QHPs. Overall, HHS believes that under this approach, issuers will see a net cost savings, as their business processes for SHOP enrollments may be more closely aligned with their current business practices for enrollments outside the SHOP, and they will no longer be remitting user fees for FF-SHOP and SBE-FP SHOP enrollments.
As noted, SHOPs will be given the flexibility to adopt an enrollment approach through which enrollments occur directly with issuers or SHOP-registered agents or brokers, to continue to operate with the same functionalities as they currently do or to develop new practices as permitted by the proposals in this rule. In any case, SHOPs will need to meet only the regulatory minimums outlined in this final rule, therefore minimizing the overall amount
Under the new enrollment approach for SHOP plan years beginning on or after January 1, 2018, HHS believes that employers seeking to purchase coverage through an FF-SHOP or SBE-FP for SHOP will experience a reduction in regulatory burden related to enrollment, despite the fact that they may be required to visit at least two websites (the SHOP website and the issuer's website) prior to completing an enrollment in SHOP coverage as they will be able to enroll in coverage through a SHOP-registered agent or broker or through a participating QHP issuer—using issuers' streamlined enrollment technologies. Employers will also be required, as described throughout this document to notify their QHP issuer of their eligibility to purchase a SHOP QHP and of their ineligibility, if their eligibility were to be revoked. Employers will also be required to inform the SHOP if they become ineligible to participate in a SHOP, or choose to withdraw their eligibility, unless the issuer is notified by the SHOP. We believe this is still less cumbersome than the existing eligibility and enrollment process.
Under the flexibilities being finalized with this rule, some employers, specifically those who offer their employees a choice of plans, will experience an increase in administrative burden with the removal of a SHOP's premium aggregation functions. Without a SHOP's premium aggregation functions, employers will have to collect the enrollment and payment information needed from each of the issuers whose plans the employer intends to offer to its employees. In the event employees select plans from multiple insurance companies, the employer will be responsible for distributing the applications for enrollment to the individual issuers, collecting payments from the employees and sending the individual payments to each issuer. Due to the decrease in issuer participation in the FF-SHOPs, some SHOP employers only have one issuer offering FF-SHOP plans in their area and will not be able to offer their employees a choice of plans across issuers. In addition, historically, a majority of employers have not offered employee choice across different issuers. Therefore HHS does not believe the potential increased burden in this area due the removal of premium aggregation functions to be significant. Employers will still be able to view a listing of all of the SHOP QHPs available, by plan category and issuer on a SHOP website. HHS expects that the actual process of enrolling in SHOP QHPs under this approach will be less burdensome than the existing enrollment approach through a SHOP website. As previously mentioned, HHS anticipated significantly lower issuer participation for the SHOP in the 2018 plan year. A decrease in issuer participation unfortunately also results in less choice for consumers. While employers may experience an increase in burden, especially if offering employees a choice of plans, under the new flexibilities for SHOPs, HHS anticipates the benefits of the finalized approach will ultimately outweigh the minimal additional costs employers could face.
Further, the Federal government will experience a dramatic reduction in the role it plays in operating an FF-SHOP and the contract support that it requires in order to support it. In 2016, the cost of running the FF-SHOP website (utilized by both FF-SHOPs and SBE-FPs for SHOP) was approximately $30 million, and HHS expects annual expenditures to drop significantly—by at least 90 percent—within a few years, as it responsibly wind-downs the integration of the FF-SHOPs.
To support the operation of FFEs, we require in § 156.50(c) that a participating issuer offering a plan through an FFE or SBE-FP must remit a user fee to HHS each month equal to the product of the monthly user fee rate specified in the annual HHS notice of benefit and payment parameters for the applicable benefit year and the monthly premium charged by the issuer for each policy under the plan where enrollment is through an FFE. In this final rule, for the 2019 benefit year, we set the monthly FFE user fee rate at 3.5 percent of the monthly premium, and the monthly SBE-FP user fee rate at 3.0 percent of the monthly premium. This increase in SBE-FP user fee rate from 2.0 percent in 2018 to 3.0 percent in 2019 will increase transfers from SBE-FP issuers to the Federal government by $20 million. Additionally, we will cease charging monthly user fees to SHOP issuers offering plans through an FF-SHOP or SBE-FP SHOP for plan years beginning on and after January 1, 2018, effective on the effective date of the final rule. This will decrease user fee transfers from SHOP issuers offering plans through an FFE or SBE-FP by approximately $6 million.
Under § 156.111, we provide States with more flexibility by offering States three new methods for selecting their State EHB-benchmark plans. Under this policy, if the State does not select one of the three methods for changing its EHB-benchmark plan, the State will default to its current EHB-benchmark plan. We recognize that, to the extent that States take advantage of the EHB-benchmark plan selection options at § 156.111, States and issuers will experience an increase in burden to develop new policies and implement new plan designs. We anticipate that most States will need to invest resources to analyze the three new EHB-benchmark selection options to make an informed selection, even if the State ultimately defaults. Several States may select one of the new options, and will need additional resources to facilitate a public notice and comment period and develop and submit the necessary documents specified by HHS (including the requisite actuarial certification) to effectuate the State's selection. Additionally, in States that choose to select their EHB-benchmark plan under any of the three available options, issuers offering plans that provide EHB will incur additional administrative costs associated with designing plans compliant with the State's newly selected EHB-benchmark plan.
Due to the many PPACA policies directly or indirectly tied to EHB, HHS recognizes the impact this policy will have on parties beyond issuers required to provide EHB-compliant plans. For example, the State's new EHB-benchmark selection can impact how issuers set their annual limitation on cost sharing and how issuers determine which benefits may not be subject to annual and lifetime dollar limits.
It is our aim that the flexibility under the policy will allow for States and issuers to be more innovative in designing benefit structures that will ultimately affect affordability for consumers. However, we realize that
We anticipate that States are more likely to select EHB-benchmark plans under this policy such that premiums have the potential to be reduced in the long-term to achieve affordability in benefit design. However, even with the generosity standard now being applied to all of the EHB-benchmark selection options, the policy may provide some ability for States, depending on the State, to select EHB-benchmark plans in a manner that will increase premiums. To the extent that a State's EHB-benchmark plan leads to higher premiums for the second lowest cost silver plan, PTC will be increased.
Consumers who have specific health needs may also be affected by the policy. In the individual and small group markets, depending on the selection made by the State in which the consumer lives, consumers with less comprehensive plans may no longer have coverage for certain services. In other States, again depending on State choices, consumers may gain coverage for some services.
As explained above, HHS anticipates that § 156.111 will generate additional costs for States, issuers, and certain consumers in the short run. However, although we are uncertain as to how States will take advantage of this flexibility, and States are not required to make any changes under this policy, we also believe the additional flexibility in plan and benefit design may produce long-term premium savings. The policies offer issuers in States that use the flexibility to select a new EHB-benchmark plan the opportunity to lower plan premiums, which will increase affordability of health insurance for consumers in the individual and small group markets who do not receive PTC and do not require the benefits that are no longer considered EHB.
When adjusting coverage of services under the options, we encourage States to consider the spillover effects in addition to the costs and utilization of these services. Spillover effects include increased use of other services, such as increased use of emergency services or increased use of public services provided by the State or other government entities, when a certain service is no longer covered by insurance. Depending on the State population's use of services and health care needs, States may arrive at different conclusions about the effects of adjusting a particular benefit. Because we do not know how States will choose to adjust their benchmark plans, we are not able to predict the effects these modifications may have on costs.
Additionally, we also proposed at § 156.115 to allow for benefit substitution to occur within the same EHB category or between EHB categories to offer additional issuer flexibility. Because issuers are already familiar with substituting benefits within benefit categories, we did not believe that broadening the policy to allow benefit substitution between benefit categories would create additional burden for issuers. We are finalizing § 156.115 to allow issuers to substitute benefits between EHB categories to the extent allowed by the State, beginning in plan year 2020. As finalized, this rule will increase burden on consumers, when their State allows between-category substitution and issuers in their State utilize such substitution. Under such circumstances, consumers who choose between plans offered in the individual and small group markets may need to spend more time and effort comparing benefits offered by different plans in order to determine what, if any, benefits are substituted, and what plan would best suit their health care and financial needs. However, some consumers may benefit from expanded access to plans that better suit their needs. We also note that States are generally primarily responsible for enforcement of EHB and continue to have the option to set criteria for benefit substitution.
We solicited comments on the impact of the proposed EHB policy and on whether other impacts should be considered.
Commenters on the premium impact and cost impact of the proposed policy typically were concerned that reducing benefits would only have a minor or no premium impact and would result in consumers having to pay more for services that are not covered, which some noted is not what consumers want. Some of these commenters noted that premiums are affected by other factors than benefits while some commenters were concerned about the risk pool impact and risk adjustment since enrollment could be affected by the scope of benefits being offered. Other commenters noted that Medicaid, the large group and self-insured plans, and PTC are also affected by the definition of EHB.
Commenters also opposed allowing issuers to substitute benefits between EHB categories. Commenters cited a wide range of concerns, including those we acknowledged in the proposed rule, as well as several that we did not, and suggested that the proposal's negative impact would be significant. For example, commenters noted that this type of substitution would permit issuers to design plans so that they were unattractive to people with certain high-cost health conditions, or people with conditions not adequately reimbursed by risk adjustment. They voiced concerns that this new market dynamic could harm the individual market risk pool and State risk adjustment programs, as well as imposing burden on certain individuals with chronic or high cost conditions affected by the lack of coverage options that met their needs and the difficulty of comparing plans due to the increased complexity of plan design.
Commenters also stated that substitution between EHB benefit categories is significantly different than substitution within categories and, therefore that current substitution practices do not provide helpful precedent for plan design, or for States' review of plans that include substitution within categories. One commenter stated that it would be particularly difficult to establish actuarial equivalence between benefits from different EHB-benefit categories, which could result in added burden for State regulators and for issuers required to comply with varying standards in different States. One commenter added that while this proposal would allow States to bar issuers from using benefit substitution between EHB categories, some States would need to take this step through legislative action, which would require time and resources simply to maintain their current policy. Finally, we did not receive any examples of how issuers could use substitution between EHB benefit categories to improve coverage options.
We appreciate commenters' concerns about the impact of allowing substitution between EHB categories. We assess the impact on States to be minimal, as under the final rule they have authority to withhold permission for substitution between categories. We also expect minimal impact on issuers, since they have experience in substituting benefits within EHB categories and may decline to substitute between categories even when their State allows it.
We anticipate both additional burden and benefit for consumers, to the extent that their States permit and issuers utilize substitution between EHB categories. It may require greater time and effort for consumers to choose among plans in the individual and small group market if some of those plans substitute some benefits for those in separate EHB categories. However, we anticipate that this additional time and effort will be limited because issuers must meet the requirement at § 156.115(b)(3)(i) to provide benefits that are substantially equal to their State's EHB-benchmark plan. The impact on consumers of the substituted benefits themselves will be mixed—some consumers stand to benefit by gaining access to benefits they desire that would not have been provided without this policy, while other consumers may find that a particular issuer no longer offers benefits they desire. Benefits no longer offered by one issuer, however, may be offered by another issuer. The net effect is uncertain.
We are removing AV level of coverage requirements for SADP issuers for coverage of pediatric dental EHB, however we are maintaining the AV certification requirement at revised § 156.150(b)(2) and codifying an operational requirement that such certification be reported to the Exchange, which issuers of SADPs have already been fulfilling, as part of the QHP certification process. We estimate that the change in AV could lead to a reduction in premiums for certain SADPs. Issuers may choose to offer more SADPs at varying premiums and levels of coverage. The offering of more SADPs and SADPs with lower premiums may lead to increased enrollment in SADPs. Because certain eligible taxpayers can use PTC to pay for the portion of SADP premiums attributable to EHB, a reduction in premiums will likely reduce the premium for purposes of the PTC, leading to a small transfer from credit recipients to the government. If enrollment increases due to potentially lower premiums there may be an overall increase in the total PTC payments by the government. The net effect is uncertain. While the requirement to report a SADP's AV is newly codified in regulation, issuers of SADPs previously reported level of coverage as part of the QHP certification process, so this change is not expected to have an impact on issuers' reporting burden.
For plan years 2019 and later, we proposed to further expand the role of States in the QHP certification process for FFEs, including FFEs where the State performs plan management functions. Specifically, we proposed to defer to States for additional review areas, including accreditation requirements at § 156.275, compliance reviews at § 156.715, minimum geographic area of the plan's service area at § 155.1055, and quality improvement strategy reporting at § 156.1130, if feasible and appropriate. We received comments that this policy would impose burdens on States, particularly those States that are not performing these reviews, and we are not finalizing this proposal for these four review areas. Some States commented that they presently lack resources, including staffing resources, to conduct these reviews. We are finalizing a policy to extend for the 2019 benefit year and beyond the QHP certification review standards related to network adequacy and ECPs that we finalized in the Market Stabilization rule. We do not anticipate this policy will increase burden on States because we believe these reviews are already being performed by States. We anticipated slight reduction in burden for issuers due to not needing to undergo duplicative reviews and a reduction in costs to the Federal government. We sought comment on whether there are burdens we are not considering. While commenters expressed concern that these policies could increase burden for consumers to obtain care from needed providers, we believe that State reviews related to network adequacy are capable of adequately preserving consumer access to care from such providers.
We are removing the meaningful difference standard at § 156.298. Issuers will have a potential reduction in administrative costs since they will no longer have to implement their internal assessments as to whether their plan offerings meet this standard. We acknowledged and commenters noted that consumers may have more QHPs to select from which may increase the burden in selecting a QHP. However, we do not have evidence from any Exchange that removing the meaningful difference standard creates any new burden on consumers.
We also anticipate that the removal of the meaningful difference standard will reduce the regulatory burden on SBE-FPs. Under § 155.200(f)(2)(iv), SBE-FPs are required to establish and oversee requirements for their issuers that are no less stringent than the meaningful difference standard as it applies to issuers participating in the FFEs. SBE-FPs will no longer need to establish such a standard or oversee it.
We are removing the requirements for SBE-FPs to enforce FFE standards for network adequacy at § 155.200(f)(2)(ii) and essential community providers at § 155.200(f)(2)(iii). We anticipate that SBE-FPs will have a potential reduction in administrative costs since they will have the flexibility to determine how to implement the network adequacy and essential community provider standards with which issuers offering QHPs through the SBE-FP must comply. We believe SBE-FPs are best positioned to determine these standards for the QHP certification process in their States, and that the removal of the requirement that SBE-FPs establish and oversee requirements for their issuers that are no less strict that the manner in which these regulatory requirements are applied to FFE issuers will streamline certain aspects of the QHP certification process, reduce issuer burden, and return traditional insurance market regulatory authority to the States.
The PPACA provides for the reduction or elimination of cost sharing for certain eligible individuals enrolled in QHPs offered through the Exchanges. This assistance helps many low- and moderate-income individuals and families obtain health insurance—for many people, cost sharing is a barrier to obtaining needed health care.
We set forth in this final rule the reductions in the maximum annual limitation on cost sharing for silver plan variations. Consistent with our analysis in previous Payment Notices, we developed three model silver level QHPs and analyzed the impact on their AVs of the reductions described in the PPACA to the estimated 2019 maximum annual limitation on cost sharing for self-only coverage. We do not believe these changes will result in a significant economic impact. Therefore, we do not believe the provisions related to cost-sharing reductions in this final rule will have an impact on the program established by and described in past Payment Notices.
We also finalized the premium adjustment percentage for the 2019 benefit year. Under § 156.130(e), and under the methodology established in the 2015 Payment Notice and amended in the 2015 Market Standards Rule for estimating average per capita premium for purposes of calculating the premium adjustment percentage, the premium adjustment percentage is the percentage (if any) by which the average per enrollee premium for employer-sponsored health insurance coverage for the preceding calendar year exceeds such average per enrollee premium for employer-sponsored health insurance for 2013. The annual premium adjustment percentage sets the rate of increase for three parameters detailed in the PPACA: The annual limitation on cost sharing (defined at § 156.130(a)), the required contribution percentage used to determine eligibility for certain exemptions under section 5000A of the Code, and the assessable payments under sections 4980H(a) and 4980H(b) of the Code. We believe that the 2019 premium adjustment percentage is well within the parameters used in the modeling of the PPACA, and we do not expect that these provisions will alter CBO's March 2016 baseline estimates of the budget impact.
We proposed to designate CHIP buy-in programs that provide identical coverage to the CHIP program under title XXI of the Act in the applicable State as minimum essential coverage. This final rule does not provide categorical designation of CHIP buy-in programs as minimum essential coverage. States will have the option of electronically submitting to HHS information regarding their plans and, after review and comparison of the coverage, HHS will verify whether or not the CHIP buy-in programs provide at least the same coverage as the title XXI CHIP programs, such that they statutorily qualify as minimum essential coverage. Currently, very few States offer CHIP buy-in programs, and such plans in two States have applied for and been recognized as minimum essential coverage. Of the States that opt into the verification process, there will be a reduction in burden related to making changes to their plans to provide at least the same coverage as the title XXI CHIP program.
We are amending § 158.221(b) to allow issuers the option to report a single quality improvement activity expense amount equal to 0.8 percent of earned premium, in lieu of reporting the actual QIA amounts in five separate categories described in § 158.150(b)(2)(i)-(v). Based on MLR data for the 2015 MLR reporting year, HHS estimates that the amendment will decrease rebate payments from issuers to consumers by approximately $23 million.
We are also amending several sections of 45 CFR part 158, subpart C (§§ 158.301, 158.321-158.322, 158.330, 158.341, 158.350) to modify the process and criteria for the Secretary to determine whether to adjust the 80 percent MLR standard in the individual market in a State. While it is uncertain what specific adjustments States may request, most adjustments previously granted by the Secretary have ranged from 70 to 75 percent. Based on MLR data for the 2015 MLR reporting year, and assuming that 22 States will request an adjustment (including 17 States that previously requested adjustments prior to 2014), HHS estimates that the amendments will decrease rebate payments from issuers to consumers or increase premiums paid by consumers to issuers by approximately $52 million (assuming a reduction of the 80 percent MLR standard to 75 percent for all 22 States) to $64 million (assuming a reduction of the MLR standard to 70 percent for all 22 States) annually, for up to 3 years at a time. This represents an estimated 74 percent to 91 percent reduction, respectively, in rebates payable in those 22 States, which together accounted for $70 million out of the nationwide total $107 million in rebates that issuers owed to individual market consumers for 2015. The actual reduction in rebates may be lower or higher depending on which States apply for an adjustment, and whether and how much the Secretary may adjust the individual market MLR standard in each State.
If regulations impose administrative costs on private entities, such as the time needed to read and interpret this final rule, we should estimate the cost associated with regulatory review. Due to the uncertainty involved with accurately quantifying the number of entities that will review the rule, we assume that the total number of unique commenters on the proposed rule will be the number of reviewers of this final rule. We acknowledge that this
We are required to promulgate a substantial portion of this rule each year under our regulations and we estimate that approximately half of the remaining provisions will cause additional regulatory review burden that stakeholders do not already anticipate. We also recognize that different types of entities are in many cases affected by mutually exclusive sections of this proposed rule, and therefore for the purposes of our estimate we assume that each reviewer reads approximately 50 percent of the rule, excluding the portion of the rule that we are required to promulgate each year.
Using the wage information from the BLS for medical and health service managers (Code 11-9111), we estimate that the cost of reviewing this rule is $105.16 per hour, including overhead and fringe benefits.
In developing the policies contained in the final rule, we considered numerous alternatives to the policies being finalized. Below, we discuss the key regulatory alternatives that we considered.
For the 2019 benefit year, we considered using only the 2016 benefit year enrollee-level EDGE data to recalibrate the risk adjustment model coefficients. However, this could lead to uncertainty in issuers' expectation of risk adjustment transfers due to the sole use of a new dataset for recalibrating the model coefficients. We believe that blending multiple years of data will promote stability for the risk adjustment coefficients year-to-year, particularly for rare conditions with small sample sizes. Therefore, we proposed to blend coefficients calculated from the 2016 benefit year enrollee-level EDGE data with 2014 and 2015 MarketScan® data. Additionally, given the timing of the proposed rule, we were unable to analyze the 2016 enrollee-level EDGE data in time to publish the coefficients calibrated using the EDGE data in the proposed rule. Similar to the 2018 benefit year final risk adjustment coefficients, we considered publishing the 2019 benefit year final risk adjustment coefficients in guidance after the publication of the final rule with more recent MarketScan® data that will become available at the end of this year. However, the 2016 benefit year enrollee-level risk adjustment data was available in time to complete our analysis and publish the final coefficients in this rule. Additionally, we considered but did not propose to use the 2016 MarketScan® data that will become available at the end of this year for the 2019 benefit year risk adjustment model recalibration. We also considered assigning higher weights to the coefficients solved from more recent data, however, to allow stability in the market have equally blended the 3 years of data. We are finalizing the 2019 benefit year model coefficients blended with 2016 EDGE data, and 2014 and 2015 MarketScan® data published in this rule.
For the State flexibility to request reductions of other applicable risk adjustment transfers, we considered alternate requirements for States requesting a reduction. We considered requiring actuarially certified standards, State's attestation noting consensus from all issuers of risk adjustment covered plans in the State's market, or simulation studies demonstrating the effect of the reduction on State's market risk pool. We determined that to ensure issuers are adequately compensated for the actuarial risk of their enrollees and do not have incentives to avoid higher risk enrollees, the State regulators need to submit evidence and analysis demonstrating the State-specific factors that warrant an adjustment to more precisely account for the differences in actuarial risk in the State's market. States must also justify the percentage reduction by providing evidence and analysis demonstrating the State-specific factors and the percentage by which those factors warrant an adjustment to more precisely account for the differences in actuarial risk in the State's market as compared to the national norm, or demonstrating the requested reduction in risk adjustment payments would be so small for issuers who would receive risk adjustment payments, that the reduction would have a
For the risk adjustment data validation program, HHS considered alternate approaches for evaluating error rates and adjusting risk scores when an error rate deviates from a statistically significant value. We considered calculating a national central tendency of errors and then adjusting risk scores only when an error rate that falls outside of the confidence interval around the national central tendency; however, we determined that the evaluation of error rates relative to a national average would likely result in significantly less accurate risk score adjustments, primarily because it would not account for differences in error rates due to issuer size or the distribution of HCCs in the enrollee population.
We considered maintaining the current applicability of the Federal rate review requirements, and continuing to review the reasonableness of student health insurance coverage rate increases subject to review. However, this rule will provide States with greater flexibility to meet the needs of their markets and reduce the burden associated with review of plans that are not part of the single risk pool. As a practical matter, student health insurance coverage has generally been given the same plan design flexibility as
We considered maintaining the current 30-day notice requirement for States to notify HHS prior to posting the required information on proposed and final rate increases. However, such advanced notice may be impractical in some States so we have decreased the notice requirement to 5 business days. We considered permitting States to post the required information on rate increases on a rolling basis. However, we agree with the concerns shared by the majority of public comments opposing that proposal, so we are maintaining the uniform posting requirement.
In adding standards for § 155.221, HHS considered making no changes to the existing rule and retaining the existing standard for agents and brokers to contract with a third-party entity approved by HHS for conducting audits under the section. In finalizing the proposal, we continue to believe that it is necessary to include issuers and to provide the necessary flexibility in oversight that both protects consumers and encourages enrollment pathway innovation for agents, brokers, and issuers using direct enrollment.
For the amendments to § 155.320, we considered developing a comprehensive database using information from employers on the plans they offer to their employees and their family members that could satisfy verification requirements under paragraph (d)(2) for all Exchanges. This approach would be resource-intensive for Exchanges, and would produce a database with limited utility due to data limitations. Developing a database; recruiting and educating employers to participate in voluntarily submitting the data; and providing technical assistance to employers for the first year of implementation on how to input the data is estimated to cost at least $38 million. Building such a database would also rely on the voluntary participation of substantially all employers. This participation would be onerous for employers. Employers would need to provide individual employee level data regarding plans the employer will offer, information that may not be available in time to populate a comprehensive database prior to the Exchange's plan year. In addition, since the PPACA does not require employers to provide to the Exchange the relevant information on what coverage they offer, Exchanges and HHS would not receive data from all employers. After weighing our options, we decided that this approach would be overly costly and burdensome, and of limited value due to gaps in the data Exchanges and HHS would be able to collect. We also considered removing the requirement to connect to an HHS-approved data source, and the requirement to use an alternative method if the Exchange does not connect to the required data sources, but were concerned about the potential impact on program integrity.
In finalizing the policy related to the SHOP enrollment process, we considered maintaining the status quo, but believe that the increase in flexibility, cost savings and reduction in burden resulting from the new enrollment approach, will have a positive impact on small businesses across the country and provide States with needed flexibility.
In finalizing the policy for the new EHB-benchmark plan selection options described at § 156.111, we considered a variety of alternatives, including maintaining the current EHB-benchmark policy without modification. Although maintaining the current policy would have promoted stability by preserving the current EHB-benchmarks across all States, we do not believe it would have offered the additional flexibility that States have requested in selecting an EHB-benchmark plan to best meet the needs of their consumer population. We also considered whether it was feasible to offer States increased flexibility by allowing them to set a range of acceptable EHB within their State, such that issuers could offer plans within that range with more limited EHB coverage or more robust EHB coverage. However, we determined that this option did not meet statutory requirements. To balance stability, flexibility, and statutory requirements, we instead finalized the proposal to offer States the expanded EHB-benchmark plan selection options at § 156.111, as well as the option to default to the State's current EHB-benchmark plan. We believe this approach will provide States with the opportunity to take advantage of greater flexibility in selecting an EHB-benchmark plan while also providing those States that value stability with the option to retain their current benchmark plan.
With respect to the provision regarding removing the AV requirement for SADPs, we considered making no change or proposing an expansion to the de minimis range to mirror the expanded de minimis range for QHPs (−4/+2 percentage points) or of +/−3 percentage points. We determined that these alternatives were less desirable because they do not provide issuers with as much flexibility to offer a range of SADPs as the proposed removal of the AV standards for SADPs. We finalized the policy to remove the level of coverage AV requirement for SADPs as proposed, but retained a requirement to certify AV and codified an operational requirement that such certification be reported to the Exchange, which SADP issuers already have been doing, as part of the QHP certification process. For the QHP certification standard regarding meaningful difference, we considered maintaining the requirement on issuers, but we believe that removing this provision will promote the offering of a variety of affordable QHPs that will meet consumers' needs, will provide issuers with more flexibility, and will remove an unnecessary regulatory requirement.
For the amendments to § 158.221(b), we considered retaining the current quality improvement activity reporting requirements, since giving issuers the option to report a standardized rate for QIA expenditures may inhibit HHS from being able to analyze trends in issuers' investment in improving the quality of health care in the future, and may also reduce rebates to consumers by allowing issuers to effectively increase their MLRs by 0.8 percent even if those issuers engaged in and spent only trivial amounts on QIA. However, this change will also potentially level the playing field among issuers to a certain extent and lead to more accurate rebate payments, since many issuers likely do engage in QIA but forego reporting that spending because the burden of analyzing, documenting, tracking, allocating, and reporting QIA expenses exceeds the benefits for MLR purposes. Because the finalized approach of giving issuers the option to report a minimal, standardized rate will reduce unwarranted regulatory and economic burdens for issuers that do not want to track and report the exact QIA amounts for their MLR calculation, we believe that the finalized approach will be more effective and represents a better balance than the current requirements.
For the amendments to part 158, subpart C, we considered retaining the current requirements for States to request an adjustment to the 80 percent MLR standard in the individual market in a State. However, HHS recognizes that many of the current State application requirements are burdensome and less relevant in the
The Regulatory Flexibility Act, (5 U.S.C. 601,
This final rule includes standards for the risk adjustment and risk adjustment data validation programs, which are intended to stabilize premiums as insurance market reforms are implemented and Exchanges facilitate increased enrollment. Because we believe that insurance firms offering comprehensive health insurance policies generally exceed the size thresholds for “small entities” established by the SBA, we do not believe that an initial regulatory flexibility analysis is required for such firms.
For purposes of the RFA, we expect the following types of entities to be affected by this final rule:
• Health insurance issuers.
• Group health plans.
We believe that health insurance issuers and group health plans will be classified under the North American Industry Classification System code 524114 (Direct Health and Medical Insurance Carriers). According to SBA size standards, entities with average annual receipts of $38.5 million or less would be considered small entities for these North American Industry Classification System codes. Issuers may possibly be classified in 621491 (HMO Medical Centers) and, if this is the case, the SBA size standard would be $32.5 million or less.
This final rule will allow enrollment in a SHOP QHP through a SHOP-registered agent or broker, or through a participating QHP issuer. The SHOPs are generally limited by statute to employers with at least one but not more than 50 employees, unless a State opts to provide that employers with from 1 to 100 employees are “small employers.” For this reason, we expect that many employers who will be affected by the finalized policies will meet the SBA standard for small entities. We do not believe that the finalized policies impose requirements on employers offering health insurance through a SHOP that are more restrictive than the current requirements on small businesses offering employer sponsored insurance. We believe the processes that we have established constitute the minimum amount of requirements necessary to implement the SHOP program and accomplish our policy goals, and that no appropriate regulatory alternatives can be developed to further lessen the compliance burden.
Based on data from MLR annual report submissions for the 2015 MLR reporting year, approximately 92 out of over 530 issuers of health insurance coverage nationwide had total premium revenue of $38.5 million or less. This estimate may overstate the actual number of small health insurance companies that may be affected, since almost 50 percent of these small companies belong to larger holding groups, and many if not all of these small companies are likely to have non-health lines of business that would result in their revenues exceeding $38.5 million. We estimate that 57 of these 92 potentially small entities may experience a decrease in the rebate amount owed to consumers under the amendments to the quality improvement activity reporting provisions in part 158, and 27 of these 57 entities are part of larger holding groups. In addition, we estimate that no small entities will be impacted by the amendments to 45 CFR part 158, subpart C. Therefore, we believe that the provisions of this final rule regarding MLR will not affect a substantial number of small entities, and further, the impact of the proposed QIA provisions on small entities will be positive.
Section 202 of the Unfunded Mandates Reform Act of 1995 (UMRA) requires that agencies assess anticipated costs and benefits and take certain other actions before issuing a final rule that includes any Federal mandate that may result in expenditures in any 1 year by a State, local, or Tribal governments, in the aggregate, or by the private sector, of $100 million in 1995 dollars, updated annually for inflation. Currently, that threshold is approximately $148 million. Although we have not been able to quantify all costs, we expect the combined impact on State, local, or Tribal governments and the private sector to be below the threshold.
Executive Order 13132 establishes certain requirements that an agency must meet when it promulgates a final rule that imposes substantial direct costs on State and local governments, preempts State law, or otherwise has Federalism implications.
In compliance with the requirement of Executive Order 13132 that agencies examine closely any policies that may have Federalism implications or limit the policy making discretion of the States, HHS has engaged in efforts to consult with and work cooperatively with affected States, including participating in conference calls with and attending conferences of the National Association of Insurance Commissioners, and consulting with State insurance officials on an individual basis.
While developing this rule, HHS attempted to balance the States' interests in regulating health insurance issuers with the need to ensure market stability. By doing so, it is HHS's view that we have complied with the requirements of Executive Order 13132.
Because States have flexibility in designing their Exchange and Exchange-related programs, State decisions will ultimately influence both administrative expenses and overall premiums. States are not required to establish an Exchange or risk adjustment program. For States that elected previously to operate an Exchange, or risk adjustment program, much of the initial cost of creating these programs was funded by Exchange Planning and Establishment Grants. After establishment, Exchanges must be financially self-sustaining, with revenue sources at the discretion of the
In HHS's view, while this final rule will not impose substantial direct requirement costs on State and local governments, this regulation has Federalism implications due to direct effects on the distribution of power and responsibilities among the State and Federal governments relating to determining standards relating to health insurance that is offered in the individual and small group markets. For example, we are finalizing proposals to provide States with substantially more flexibility in selecting an EHB-benchmark plan, to explore ways to make it easier for States to establish and maintain a State Exchange, to provide States with substantially more flexibility in how they operate a SHOP, to provide States with the option to request a reduction to risk adjustment transfers in their small group market; and to make it easier for States to apply for and be granted an adjustment to the MLR standard in their State. We are also returning flexibility to States in their review of rate increases. We are also finalizing the proposal to give States the choice to review rate increases for student health insurance coverage. We are also reducing the advanced notification that States must give HHS about the posting of rate increases from 30 days to 5 business days. Finally, States will no longer be required to seek approval if the State-specific threshold for reasonableness review is lower than the Federal default rate review threshold.
This final rule is subject to the Congressional Review Act provisions of the Small Business Regulatory Enforcement Fairness Act of 1996 (5 U.S.C. 801,
Executive Order 13771, titled Reducing Regulation and Controlling Regulatory Costs, was issued on January 30, 2017. Section 2(a) of Executive Order 13771 requires an agency, unless prohibited by law, to identify at least two existing regulations to be repealed when the agency publicly proposes for notice and comment, or otherwise promulgates, a new regulation. In furtherance of this requirement, section 2(c) of Executive Order 13771 requires that the new incremental costs associated with 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 final rule is an E.O. 13771 deregulatory action.
Health care, Health insurance, Reporting and recordkeeping requirements.
Administrative practice and procedure, Health care, Health insurance, Health records, Intergovernmental relations, Organization and functions (Government agencies), Reporting and recordkeeping requirements.
Administrative practice and procedure, Claims, Health care, Health insurance, Penalties, Reporting and recordkeeping requirements.
Administrative practice and procedure, Advertising, Brokers, Conflict of interests, Consumer protection, Grants administration, Grant programs—health, Health care, Health insurance, Health maintenance organizations (HMO), Health records, Hospitals, Indians, Individuals with disabilities, Intergovernmental relations, Loan programs—health, Medicaid, Organization and functions (Government agencies), Public assistance programs, Reporting and recordkeeping requirements, Technical assistance, Women and youth.
Administrative practice and procedure, Advertising, Advisory committees, Conflict of interests, Consumer protection, Grant programs—health, Grants administration, Health care, Health insurance, Health maintenance organization (HMO), Health records, Hospitals, Indians, Individuals with disabilities, Loan programs—health, Medicaid, Organization and functions (Government agencies), Public assistance programs, Reporting and recordkeeping requirements, State and local governments, Sunshine Act, Technical assistance, Women, Youth.
Employee benefit plans, Health insurance, Health maintenance organizations (HMO), Health records, Hospitals, Indians, Individuals with disabilities, Medicaid, Organization and functions (Government agencies), Public assistance programs, Reporting and recordkeeping requirements, Technical assistance, Women and youth.
Administrative practice and procedure, Claims, Health care, Health insurance, Penalties, Reporting and recordkeeping requirements.
For the reasons set forth in the preamble, the Department of Health and Human Services amends 45 CFR parts 147, 153, 154, 155, 156, 157 and 158 as set forth below.
Secs. 2701 through 2763, 2791, and 2792 of the Public Health Service Act (42 U.S.C. 300gg through 300gg-63, 300gg-91, and 300gg-92), as amended.
(c) * * *
(3) * * *
(iii) * * *
(D) To the extent permitted by applicable State law and, in the case of coverage offered through a SHOP, as permitted by the SHOP, apply this paragraph (c)(3)(iii) uniformly among group health plans enrolling in that product, giving those group health plans the option to pay premiums based on average enrollee premium amounts.
The revisions read as follows:
(b) * * *
(1) * * *
(i) * * *
(B) In the case of a group health plan in the small group market that cannot comply with employer contribution or group participation rules for the offering of health insurance coverage, as allowed under applicable State law, and in the case of a QHP offered in the SHOP, as permitted by § 156.285(e) or § 156.286(e) of this subchapter, a health insurance issuer may restrict the availability of coverage to an annual enrollment period that begins November 15 and extends through December 15 of each calendar year.
(C) With respect to coverage in the small group market, and in the large group market if such coverage is offered through a SHOP in a State, for a group enrollment received on the first through the fifteenth day of any month, the coverage effective date must be no later than the first day of the following month. For a group enrollment received on the 16th through last day of any month, the coverage effective date must be no later than the first day of the second following month. In either such case, a small employer may instead opt for a later effective date within a quarter for which small group market rates are available.
(ii)
(2) * * *
(i) A health insurance issuer in the individual market must provide a limited open enrollment period for the triggering events described in § 155.420(d) of this subchapter, excluding, with respect to coverage offered outside of an Exchange, the following:
(ii) In applying this paragraph (b)(2), a reference in § 155.420 (other than in § 155.420(a)(5)) of this subchapter to a “QHP” is deemed to refer to a plan, a reference to “the Exchange” is deemed to refer to the applicable State authority, and a reference to a “qualified individual” is deemed to refer to an individual in the individual market.
Secs. 1311, 1321, 1341-1343, Pub. L. 111-148, 24 Stat. 119.
(d)
(1)
(i) Supporting evidence and analysis demonstrating the State-specific factors that warrant an adjustment to more precisely account for the differences in actuarial risk in the State market;
(ii) The adjustment percentage of up to 50 percent requested for the State individual, small group or merged market; and
(iii) A justification for the reduction requested demonstrating the State-specific factors that warrant an adjustment to more precisely account for relative risk differences in the State individual, small group or merged market, or demonstrating the requested reduction would have
(2)
(3)
(4)
(A) That State-specific rules or other relevant factors warrant an adjustment to more precisely account for relative risk differences in the State individual, small group or merged market and support the percentage reduction to risk adjustment transfers requested; or
(B) That State-specific rules or other relevant factors warrant an adjustment to more precisely account for relative risk differences in the State's individual, small group or merged market and the requested reduction would have
(ii) HHS may approve a reduction amount that is lower than the amount requested by the State if the supporting evidence and analysis do not fully support the requested reduction amount. HHS will assess other relevant factors, including the premium impact of the transfer reduction for the State market.
(b) * * *
(6) An issuer must provide the initial validation auditor and the second validation auditor with all relevant source enrollment documentation, all claims and encounter data, and medical record documentation from providers of services to each enrollee in the applicable sample without unreasonable delay and in a manner that reasonably assures confidentiality and security in transmission. Notwithstanding any other provision of this section, a qualified provider that is licensed to diagnose mental illness by the State and that is prohibited from furnishing a complete medical record by applicable State privacy laws concerning any enrollee's treatment for one or more mental or behavioral health conditions may furnish a signed mental or behavioral health assessment that, to the extent permissible under applicable Federal and State privacy laws, should contain: The enrollee's name; sex; date of birth; current status of all mental or behavioral health diagnoses; and dates of service. The mental or behavioral health assessment should be signed by the provider and submitted with an attestation that the provider is prohibited from furnishing a complete medical record by applicable State privacy laws.
(8) The initial validation auditor must measure and report to the issuer and HHS, in a manner and timeframe specified by HHS, its inter-rater reliability rates among its reviewers. The initial validation auditor must achieve a consistency measure of at least 95 percent for his or her review outcomes, except that for validation of risk adjustment data for the 2015 and 2016 benefit years, the initial validation auditor may meet an inter-rater reliability standard of 85 percent for review outcomes.
(9) HHS may impose civil money penalties in accordance with the procedures set forth in § 156.805(b) through (e) of this subchapter if an issuer of a risk adjustment covered plan—
(i) Fails to engage an initial validation auditor;
(ii) Fails to submit the results of an initial validation audit to HHS;
(iii) Engages in misconduct or substantial non-compliance with the risk adjustment data validation standards and requirements applicable to issuers of risk adjustment covered plans; or
(iv) Intentionally or recklessly misrepresents or falsifies information that it furnishes to HHS.
Section 2794 of the Public Health Service Act (42 U.S.C. 300gg-94).
(b)
(1) Grandfathered health plan coverage as defined in § 147.140 of this subchapter;
(2) Excepted benefits as described in section 2791(c) of the PHS Act; and
(3) For coverage effective on or after July 1, 2018, student health insurance coverage as defined in § 147.145 of this subchapter.
(a) A rate increase filed in a State, or effective in a State that does not require a rate increase to be filed, is subject to review if:
(1) The rate increase is 15 percent or more applicable to a 12-month period that begins on January 1, as calculated under paragraph (b) of this section; or
(2) The rate increase meets or exceeds a State-specific threshold applicable to a 12-month period that begins on January 1, as calculated under paragraph (b) of this section, determined by the Secretary. A State-specific threshold shall be based on factors impacting rate increases in a State to the extent that the data relating to such State-specific factors are available by August 1 of the preceding year. States interested in proposing a State-specific threshold greater than the Federal default stated in paragraph (a)(1) of this section are required to submit a proposal for approval of such threshold to the Secretary by August 1 of the preceding year, in the form and manner specified by the Secretary.
(b) A rate increase meets or exceeds the applicable threshold set forth in paragraph (a) of this section if the average increase, including premium rating factors described in § 147.102 of this subchapter, for all enrollees weighted by premium volume for any plan within the product meets or exceeds the applicable threshold.
(c) If a rate increase that does not otherwise meet or exceed the threshold under paragraph (b) of this section meets or exceeds the threshold when combined with a previous increase or increases during the 12-month period preceding the date on which the rate increase would become effective, then the rate increase must be considered to meet or exceed the threshold and is subject to review under § 154.210, and such review shall include a review of the aggregate rate increases during the applicable 12-month period.
(h) * * *
(2) CMS will make available to the public on its website the information contained in Parts I and III of each Rate Filing Justification that is not a trade secret or confidential commercial or financial information as defined in HHS's Freedom of Information Act regulations, 45 CFR 5.31(d).
(b) * * *
(2) If a State intends to make the information in paragraph (b)(1)(i) of this section available to the public prior to the date specified by the Secretary, or if it intends to make the information in paragraph (b)(1)(ii) of this section available to the public prior to the first day of the annual open enrollment period in the individual market for the applicable calendar year, the State must notify CMS in writing, no later than five (5) business days prior to the date it intends to make the information public, of its intent to do so and the date it intends to make the information public.
Title I of the Affordable Care Act, sections 1301, 1302, 1303, 1304, 1311, 1312, 1313, 1321, 1322, 1331, 1332, 1334, 1402, 1411, 1412, 1413, Pub. L. 111-148, 124 Stat. 119 (42 U.S.C. 18021-18024, 18031-18033, 18041-18042, 18051, 18054, 18071, and 18081-18083).
(c)
(f) * * *
(2) * * *
(ii) [Reserved]
(iii) [Reserved]
(iv) [Reserved]
(4) A State Exchange on the Federal platform that utilizes the Federal
(c) * * *
(2) The Exchange must include an entity from at least one of the following categories for receipt of a Navigator grant:
(e) * * *
(7) In a Federally-facilitated Exchange, no individual or entity shall be ineligible to operate as a Navigator solely because its principal place of business is outside of the Exchange service area;
(h)
(a) An agent, broker, or issuer participating in direct enrollment must engage a third-party entity to conduct an annual review to demonstrate operational readiness in accordance with § 155.220(c)(3)(i)(K) and with § 156.1230(b)(2) of this subchapter. The third-party entity will be a downstream or delegated entity of the agent, broker or issuer that participates or wishes to participate in direct enrollment.
(b) An agent, broker, or issuer participating in direct enrollment must satisfy the requirement to demonstrate operational readiness under paragraph (a) of this section by engaging a third-party entity that meets each of the following standards:
(1) Has experience conducting audits or similar services, including experience with relevant privacy and security standards;
(2) Adheres to HHS specifications for content, format, privacy, and security in the conduct of an operational readiness review, which includes ensuring that agents, brokers, and issuers are in compliance with the applicable privacy and security standards and other applicable requirements;
(3) Collects, stores, and shares with HHS all data related to the third-party entity's audit of agents, brokers, and issuers in a manner, format, and frequency specified by HHS until 10 years from the date of creation, and complies with the privacy and security standards HHS adopts for agents, brokers, and issuers as required in accordance with § 155.260;
(4) Discloses to HHS any financial relationships between the entity and individuals who own or are employed by an agent, broker, or issuer for which it is conducting an operational readiness review.
(5) Complies with all applicable Federal and State requirements;
(6) Ensures, on an annual basis, that appropriate staff successfully complete operational readiness review training as established by HHS prior to conducting audits under paragraph (a) of this section;
(7) Permits access by the Secretary and the Office of the Inspector General or their designees in connection with their right to evaluate through audit, inspection, or other means, to the third-party entity's books, contracts, computers, or other electronic systems, relating to the third-party entity's audits of agent's, broker's, or issuer's obligations in accordance with Federal standards under paragraph (a) of this section until 10 years from the date of creation; and
(8) Complies with other minimum business criteria as specified in guidance by HHS.
(c) An agent, broker or issuer may engage multiple third-party entities to conduct the audit under paragraph (a) of this section and each third-party entity must satisfy the standards outlined under paragraph (b) of this section.
(f) * * *
(4)
The revisions and additions read as follows:
(c) * * *
(3) * * *
(iii)
(D) If an applicant's attestation to projected annual household income, as described in paragraph (c)(3)(ii)(B) of this section, is greater than or equal to 100 percent but not more than 400 percent of the FPL for the benefit year for which coverage is requested and is more than a reasonable threshold above the annual household income computed in accordance with paragraph (c)(3)(ii)(A) of this section, the data described in paragraph (c)(3)(ii)(A) of this section indicates that projected annual household income is under 100 percent FPL, and the Exchange has not verified the applicant's MAGI-based income through the process specified in paragraph (c)(2)(ii) of this section to be within the applicable Medicaid or CHIP MAGI-based income standard, the Exchange must proceed in accordance with § 155.315(f)(1) through (4). However, this paragraph (c)(3)(iii)(D) does not apply if the applicant is a non-citizen who is lawfully present and ineligible for Medicaid by reason of immigration status. For the purposes of this paragraph, a reasonable threshold is established by the Exchange in guidance and approved by HHS, but must not be less than 10 percent, and can also include a threshold dollar amount.
(E) If, at the conclusion of the period specified in § 155.315(f)(2)(ii), the Exchange remains unable to verify the applicant's attestation, the Exchange must determine the applicant's eligibility based on the information described in paragraph (c)(3)(ii)(A) of this section, notify the applicant of such determination in accordance with the notice requirements specified in § 155.310(g), and implement such determination in accordance with the effective dates specified in § 155.330(f).
(F) If, at the conclusion of the period specified in § 155.315(f)(2)(ii), the Exchange remains unable to verify the applicant's attestation and the information described in paragraph (c)(3)(ii)(A) of this section is unavailable, the Exchange must determine the tax filer ineligible for advance payments of the premium tax credit and cost-sharing reductions, notify the applicant of such determination in accordance with the notice requirements specified in § 155.310(g), and discontinue any advance payments of the premium tax credit and cost-sharing reductions in accordance with the effective dates specified in § 155.330(f).
(vi) * * *
(C)
(
(
(D)
(F) If, at the conclusion of the period specified in § 155.315(f)(2)(ii), the Exchange remains unable to verify the applicant's attestation, the Exchange must determine the applicant's eligibility based on the information described in paragraph (c)(3)(ii)(A) of this section, notify the applicant of such determination in accordance with the notice requirements specified in § 155.310(g), and implement such determination in accordance with the effective dates specified in § 155.330(f).
(G) If, at the conclusion of the period specified in § 155.315(f)(2)(ii), the Exchange remains unable to verify the applicant's attestation for the tax filer and the information described in paragraph (c)(3)(ii)(A) of this section is unavailable, the Exchange must determine the tax filer ineligible for advance payments of the premium tax credit and cost-sharing reductions, notify the applicant of such determination in accordance with the notice requirement specified in § 155.310(g), and discontinue any advance payments of the premium tax credit and cost-sharing reductions in accordance with the effective dates specified in § 155.330(f).
(d) * * *
(4)
The revisions read as follows:
(a) * * *
(4) * * *
(iii) For the other triggering events specified in paragraph (d) of this section, except for paragraphs (d)(2)(i), (d)(4), (d)(6)(i) and (ii) of this section for becoming newly eligible for CSRs, (d)(8), (9), (10) and (12) of this section:
(A) If an enrollee qualifies for a special enrollment period, the Exchange must allow the enrollee and his or her dependents to change to another QHP within the same level of coverage (or one metal level higher or lower, if no such QHP is available), as outlined in § 156.140(b) of this subchapter; or
(B) If a dependent qualifies for a special enrollment period, and an enrollee is adding the dependent to his or her QHP, the Exchange must allow the enrollee to add the dependent to his or her current QHP; or, if the QHP's business rules do not allow the dependent to enroll, the Exchange must allow the enrollee and his or her dependents to change to another QHP within the same level of coverage (or one metal level higher or lower, if no such QHP is available), as outlined in § 156.140(b) of this subchapter, or enroll the new qualified individual in a separate QHP.
(5)
(b) * * *
(2) * * *
(i) In the case of birth, adoption, placement for adoption, placement in foster care, or child support or other court order as described in paragraph (d)(2)(i) of this section, the Exchange must ensure that coverage is effective for a qualified individual or enrollee on the date of birth, adoption, placement for adoption, placement in foster care, or effective date of court order; or it may permit the qualified individual or enrollee to elect a coverage effective date of the first of the month following plan selection; or in accordance with paragraph (b)(1) of this section. If the Exchange permits the qualified individual or enrollee to elect a coverage effective date of either the first of the month following the date of plan selection or in accordance with paragraph (b)(1) of this section, the Exchange must ensure coverage is effective on the date duly selected by the qualified individual or enrollee.
(d) * * *
(1) * * *
(iii) Loses pregnancy-related coverage described under section 1902(a)(10)(A)(i)(IV) and (a)(10)(A)(ii)(IX) of the Act (42 U.S.C. 1396a(a)(10)(A)(i)(IV), (a)(10)(A)(ii)(IX)) or loses access to health care services through coverage provided to a pregnant woman's unborn child, based on the definition of a child in 42 CFR 457.10. The date of the loss of coverage is the last day the qualified individual would have pregnancy-related coverage or access to health care services through the unborn child coverage; or
(10) * * *
(i) Is a victim of domestic abuse or spousal abandonment as defined by 26 CFR 1.36B-2 or a dependent or unmarried victim within a household, is enrolled in minimum essential coverage, and sought to enroll in coverage separate from the perpetrator of the abuse or abandonment; or
The revisions and additions read as follows:
(d) * * *
(2) * * *
(ii) If the enrollee does not provide reasonable notice, fourteen days after the termination is requested by the enrollee; or
(iii) At the option of the Exchange, on the date on which the termination is requested by the enrollee, or on another prospective date selected by the enrollee; or
(iv) If an Exchange does not require an earlier termination date in accordance with paragraph (d)(2)(iii) of this section, at the option of the QHP issuer, on a date on or after the termination is requested by the enrollee that is less than 14 days after the termination is requested by the enrollee, if the enrollee requests an earlier termination date; or
(v) At the option of the Exchange, for an individual who is newly determined eligible for Medicaid, CHIP, or the Basic Health Program, if a Basic Health Program is operating in the service area of the Exchange, the day before the enrollee's date of eligibility for Medicaid, CHIP, or the Basic Health Program.
(d) * * *
(2) * * *
(iv) For an individual who is ineligible to purchase coverage under an eligible employer-sponsored plan, the Exchange determines the required contribution for coverage in accordance with section 5000A(e)(1)(B)(ii) of the Code, inclusive of all members of the family, as defined in 26 CFR 1.36B-1(d), who have not otherwise been granted an exemption through the Exchange and who are not treated as eligible to purchase coverage under an eligible employer-sponsored plan, in accordance with paragraph (d)(4)(ii) of this section. If there is not a bronze level plan offered through the Exchange in the
(h) * * *
(2) The Exchange will only accept an application for an exemption described in § 155.605(d)(1) during one of the 3 calendar years after the month or months during which the applicant attests that the hardship occurred.
(a)
(2) For plan years beginning on or after January 1, 2018, an Exchange must provide for the establishment of a SHOP that meets the requirements of this subpart and is designed to assist qualified employers in facilitating the enrollment of their employees in qualified health plans.
(e)
(a)
(1) Requirements related to individual eligibility determinations in subpart D of this part;
(2) Requirements related to enrollment of qualified individuals described in subpart E of this part;
(3) The requirement to issue certificates of exemption in accordance with § 155.200(b); and
(4) Requirements related to the payment of premiums by individuals, Indian tribes, tribal organizations and urban Indian organizations under § 155.240.
(b)
(1)
(2)
(3)
(A) Must allow an employer to make available to qualified employees all QHPs at the level of coverage selected by the employer as described in paragraph (b)(2) of this section, and
(B) May allow an employer to make one or more QHPs available to qualified employees by a method other than the method described in paragraph (b)(2) of this section.
(ii) A Federally-facilitated SHOP will provide a qualified employer a choice of two methods to make QHPs available to qualified employees:
(A) The employer may choose a level of coverage as described in paragraph (b)(2) of this section, or
(B) The employer may choose a single QHP.
(iii) A SHOP may, and a Federally-facilitated SHOP will provide a qualified employer a choice of two methods to make stand-alone dental plans available to qualified employees:
(A) The employer may choose to make available a single stand-alone dental plan.
(B) The employer may choose to make available all stand-alone dental plans offered through a SHOP.
(iv) A SHOP may also provide a qualified employer with a choice of a third method to make QHPs available to qualified employees by offering its qualified employees a choice of all QHPs offered through the SHOP by a single issuer across all available levels of coverage, as described in section 1302(d)(1) of the Affordable Care Act and implemented in § 156.140(b) of this subchapter. A State with a Federally-facilitated SHOP may recommend that the Federally-facilitated SHOP not make this additional option available in that State, by submitting a letter to HHS in advance of the annual QHP certification application deadline, by a date to be established by HHS. The State's letter must describe and justify the State's recommendation, based on the anticipated impact this additional option would have on the small group market and consumers.
(v) A SHOP may also provide a qualified employer with a choice of a third method to make stand-alone dental plans available to qualified employees by offering its qualified employees a choice of all stand-alone dental plans offered through the SHOP by a single issuer. A State with a Federally-facilitated SHOP may recommend that the Federally-facilitated SHOP not make this additional option available in that State, by submitting a letter to HHS in advance of the annual QHP certification application deadline, by a date to be established by HHS. The State's letter must describe and justify the State's recommendation, based on the anticipated impact this additional option would have on the small group market and consumers.
(vi) States operating a State Exchange utilizing the Federal platform for SHOP enrollment functions will have the same employer choice models available as States with a Federally-facilitated SHOP, except that a State with a State Exchange utilizing the Federal platform for SHOP enrollment functions may decide against offering the employer choice models specified in paragraphs (b)(3)(iv) and (v) of this section in that State, provided that the State notifies HHS of that decision in advance of the annual QHP certification application deadline, by a date to be established by HHS.
(4)
(5)
(6)
(i) Require all QHP issuers to make any change to rates at a uniform time that is no more frequently than quarterly.
(A) In a Federally-facilitated SHOP, rates may be updated quarterly with effective dates of January 1, April 1, July 1, or October 1 of each calendar year. The updated rates must be submitted to HHS at least 60 days in advance of the effective date of the rates.
(B) [Reserved]
(ii) Prohibit all QHP issuers from varying rates for a qualified employer during the employer's plan year.
(7)
(8)
(9)
(10)
(i) Subject to § 147.104 of this subchapter, a Federally-facilitated SHOP must use a minimum participation rate of 70 percent, calculated as the number of full-time employees accepting coverage offered by a qualified employer plus the number of full-time employees who, at the time the employer submits the SHOP group enrollment, are enrolled in coverage through another group health plan, governmental coverage (such as Medicare, Medicaid, or TRICARE), coverage sold through the individual market, or in other minimum essential coverage, divided by the number of full-time employees offered coverage.
(ii) Notwithstanding paragraphs (b)(10)(i) of this section, a Federally-facilitated SHOP may utilize a different minimum participation rate in a State if there is evidence that a State law sets a minimum participation rate or that a higher or lower minimum participation rate is customarily used by the majority of QHP issuers in that State for products in the State's small group market outside the SHOP.
(11)
(c)
(d)
(e)
(h)
(a)
(b)
(c)
(1) May establish, in addition to or in lieu of reliance on the application, additional methods to verify the information provided by the applicant on the applicable application;
(2) Must collect only the minimum information necessary for verification of eligibility in accordance with the eligibility standards described in § 155.710; and
(3) May not perform individual market Exchange eligibility determinations or verifications described in subpart D of this part.
(d)
(1) Make a reasonable effort to identify and address the causes of such inconsistency, including through typographical or other clerical errors;
(2) Notify the employer of the inconsistency;
(3) Provide the employer with a period of 30 days from the date on which the notice described in paragraph (d)(2) of this section is sent to the employer to either present satisfactory documentary evidence to support the employer's application, or resolve the inconsistency; and
(4) If, after the 30-day period described in paragraph (d)(2) of this section, the SHOP has not received satisfactory documentary evidence, the SHOP must—
(i) Notify the employer of its denial or termination of eligibility in accordance with paragraph (e) of this section and of the employer's right to appeal such determination; and
(ii) If the employer was enrolled pending the confirmation or verification of eligibility information, discontinue the employer's participation in the
(e)
(f)
(g)
(j)
(a)
(b)
(c)
(l)
(a)
(b)
(c)
(2) The SHOP must ensure that issuers offering QHPs through a SHOP provide a special enrollment period for a qualified employee or a dependent of a qualified employee who;
(i) Experiences an event described in § 155.420(d)(1) (other than paragraph (d)(1)(ii)), or experiences an event described in § 155.420(d)(2), (4), (5), (7), (8), (9), (10), (11), or (12);
(ii) Loses eligibility for coverage under a Medicaid plan under title XIX of the Social Security Act or a State child health plan under title XXI of the Social Security Act; or
(iii) Becomes eligible for assistance, with respect to coverage under a SHOP, under such Medicaid plan or a State child health plan (including any waiver or demonstration project conducted under or in relation to such a plan).
(3) A qualified employee or dependent of a qualified employee who experiences a qualifying event described in paragraph (j)(2) of this section has:
(i) Thirty (30) days from the date of a triggering event described in paragraph (c)(2)(i) of this section to select a QHP through the SHOP; and
(ii) Sixty (60) days from the date of a triggering event described in paragraph (c)(2)(ii) or (iii) of this section to select a QHP through the SHOP;
(4) A dependent of a qualified employee is not eligible for a special enrollment period if the employer does not extend the offer of coverage to dependents.
(5) The effective dates of coverage for special enrollment periods are determined using the provisions of § 155.420(b).
(6) Loss of minimum essential coverage is determined using the provisions of § 155.420(e).
(d)
(e)
(h)
(a)
(b)
(1) Employer name and address of employer's locations;
(2) Information sufficient to confirm the employer is a small employer;
(3) Employer Identification Number (EIN); and
(4) Information sufficient to confirm that the employer is offering, at a minimum, all full-time employees coverage in a QHP through a SHOP.
(c)
(d)
(e)
(1) Accept applications from SHOP application filers; and
(2) Provide the tools to file an employer eligibility application via an internet website.
(f)
(2) The SHOP is not permitted to collect information on the single employer or on an employee application unless that information is necessary to determine SHOP eligibility or effectuate enrollment through the SHOP.
(g)
(h)
(p)
(a)
(b)
(2) The appeals entity must conduct appeals in accordance with the requirements established in this section and §§ 155.505(e) through (h) and 155.510(a)(1) and (2) and (c).
(c)
(1) A notice of denial or termination of eligibility under § 155.716(e); or
(2) A failure by the SHOP to provide a timely eligibility determination or a timely notice of an eligibility determination in accordance with § 155.716(e).
(d)
(1) The reason for the denial or termination of eligibility, including a citation to the applicable regulations; and
(2) The procedure by which the employer may request an appeal of the denial or termination of eligibility.
(e)
(1) Allow an employer to request an appeal within 90 days from the date of the notice of denial or termination of eligibility to—
(i) The SHOP or the appeals entity; or
(ii) HHS, if no State Exchange that provides for establishment of a SHOP has been established;
(2) Accept appeal requests submitted through any of the methods described in § 155.520(a)(1);
(3) Comply with the requirements of § 155.520(a)(2) and (3); and
(4) Consider an appeal request valid if it is submitted in accordance with paragraph (e)(1) of this section.
(f)
(i) Send timely acknowledgement to the employer of the receipt of the appeal request, including—
(A) An explanation of the appeals process; and
(B) Instructions for submitting additional evidence for consideration by the appeals entity.
(ii) Promptly notify the SHOP of the appeal, if the appeal request was not initially made to the SHOP.
(2) Upon receipt of an appeal request that is not valid because it fails to meet the requirements of this section, the appeals entity must—
(i) Promptly and without undue delay, send written notice to the employer that is appealing that—
(A) The appeal request has not been accepted,
(B) The nature of the defect in the appeal request; and
(C) An explanation that the employer may cure the defect and resubmit the appeal request if it meets the timeliness requirements of paragraph (e) of this section, or within a reasonable timeframe established by the appeals entity.
(ii) Treat as valid an amended appeal request that meets the requirements of this section.
(g)
(i) The appeal request, if the appeal request was initially made to the SHOP; and
(ii) The eligibility record of the employer that is appealing.
(2) The appeals entity must promptly confirm receipt of records transmitted pursuant to paragraph (g)(1) of this section to the SHOP that transmitted the records.
(h)
(1) Must dismiss an appeal if the employer that is appealing—
(i) Withdraws the request in accordance with the standards set forth in § 155.530(a)(1); or
(ii) Fails to submit an appeal request meeting the standards specified in paragraph (e) of this section.
(2) Must provide timely notice to the employer that is appealing of the dismissal of the appeal request, including the reason for dismissal, and must notify the SHOP of the dismissal.
(3) May vacate a dismissal if the employer makes a written request within 30 days of the date of the notice of dismissal showing good cause why the dismissal should be vacated.
(i)
(j)
(1) Comply with the standards set forth in § 155.555(i)(1) and (3); and
(2) Consider the information used to determine the employer's eligibility as well as any additional relevant evidence submitted during the course of the appeal by the employer or employee.
(k)
(1) Be based solely on—
(i) The evidence referenced in paragraph (j)(2) of this section;
(ii) The eligibility requirements for the SHOP under § 155.710(b), as applicable.
(2) Comply with the standards set forth in § 155.545(a)(2) through (5)
(3) Be effective as follows:
(i) If an employer is found eligible under the decision, then at the employer's option, the effective date of coverage or enrollment through the SHOP under the decision can either be made retroactive to the effective date of coverage or enrollment through the
(ii) If the employer is found ineligible under the decision, then the appeal decision is effective as of the date of the notice of the appeal decision.
(l)
(m)
(n)
(o)
Title I of the Affordable Care Act, sections 1301-1304, 1311-1313, 1321-1322, 1324, 1334, 1342-1343, 1401-1402, Pub. L. 111-148, 124 Stat. 119 (42 U.S.C. 18021-18024, 18031-18032, 18041-18042, 18044, 18054, 18061, 18063, 18071, 18082, 26 U.S.C. 36B, and 31 U.S.C. 9701).
For plan years beginning before January 1, 2020, each State may identify a base-benchmark plan according to the selection criteria described below:
(d)
(a) Subject to paragraphs (b), (c), (d) and (e) of this section, for plan years beginning on or after January 1, 2020, a State may change its EHB-benchmark plan by:
(1) Selecting the EHB-benchmark plan that another State used for the 2017 plan year under § 156.100 and § 156.110;
(2) Replacing one or more categories of EHBs established at § 156.110(a) in the State's EHB-benchmark plan used for the 2017 plan year with the same category or categories of EHB from the EHB-benchmark plan that another State used for the 2017 plan year under § 156.100 and § 156.110; or
(3) Otherwise selecting a set of benefits that would become the State's EHB-benchmark plan.
(b) A State's EHB-benchmark plan must:
(1)
(2)
(A) One of the selecting State's 10 base-benchmark plan options established at § 156.100, and available for the selecting State's selection for the 2017 plan year; or
(B) The largest health insurance plan by enrollment within one of the five largest large group health insurance products by enrollment in the State, as product and plan are defined at § 144.103 of this subchapter, provided that:
(
(
(
(
(ii) Not exceed the generosity of the most generous among a set of comparison plans, including:
(A) The State's EHB-benchmark plan used for the 2017 plan year, and
(B) Any of the State's base-benchmark plan options for the 2017 plan year described in § 156.100(a)(1), supplemented as necessary under § 156.110.
(iii) Not have benefits unduly weighted towards any of the categories of benefits at § 156.110(a);
(iv) Provide benefits for diverse segments of the population, including women, children, persons with disabilities, and other groups; and
(v) Not include discriminatory benefit designs that contravene the non-discrimination standards defined in § 156.125.
(c) The State must provide reasonable public notice and an opportunity for public comment on the State's selection of an EHB-benchmark plan that includes posting a notice on its opportunity for public comment with associated information on a relevant State website.
(d) A State must notify HHS of the selection of a new EHB-benchmark plan by a date to be determined by HHS for each applicable plan year.
(1) If the State does not make a selection by the annual selection date, or its benchmark plan selection does not meet the requirements of this section and section 1302 of the PPACA, the State's EHB-benchmark plan for the applicable plan year will be that State's EHB-benchmark plan applicable for the prior year.
(2) [Reserved]
(e) A State changing its EHB-benchmark plan under this section must submit documents in a format and manner specified by HHS by a date determined by HHS. These must include:
(1) A document confirming that the State's EHB-benchmark plan definition complies with the requirements under paragraphs (a), (b) and (c) of this section, including information on which selection option under paragraph (a) of this section the State is using, and whether the State is using another State's EHB-benchmark plan;
(2) An actuarial certification and an associated actuarial report from an actuary, who is a member of the American Academy of Actuaries, in accordance with generally accepted actuarial principles and methodologies, that affirms:
(i) That the State's EHB-benchmark plan provides a scope of benefits that is equal to, or greater than, to the extent any supplementation is required to provide coverage within each EHB category at § 156.110(a), the scope of benefits provided under a typical employer plan, as defined at (b)(2)(i) of this section; and
(ii) That the State's EHB-benchmark plan does not exceed the generosity of the most generous among the plans listed in paragraphs (b)(2)(ii)(A) and (B) of this section.
(3) The State's EHB-benchmark plan document that reflects the benefits and limitations, including medical management requirements, a schedule of benefits and, if the State is selecting its EHB-benchmark plan using the
(4) Other documentation specified by HHS, which is necessary to operationalize the State's EHB-benchmark plan.
(b) An issuer of a plan offering EHB may substitute benefits for those provided in the EHB-benchmark plan under the following conditions—
(1) The issuer substitutes a benefit that:
(i) Is actuarially equivalent to the benefit that is being replaced as determined in paragraph (b)(4) of this section; and
(ii) Is not a prescription drug benefit.
(2) An issuer may substitute a benefit under this paragraph:
(i) Within the same EHB category, unless prohibited by applicable State requirements; and
(ii) For plan years beginning on or after January 1, 2020, between EHB categories, if the State in which the plan will be offered has notified HHS that substitution between EHB categories is permitted in the State.
(3) The plan that includes substituted benefits must:
(i) Continue to comply with the requirements of paragraph (a) of this section, including by providing benefits that are substantially equal to the EHB-benchmark plan;
(ii) Provide an appropriate balance among the EHB categories such that benefits are not unduly weighted toward any category; and
(iii) Provide benefits for diverse segments of the population.
(4) The issuer submits to the State evidence of actuarial equivalence that is:
(i) Certified by a member of the American Academy of Actuaries;
(ii) Based on an analysis performed in accordance with generally accepted actuarial principles and methodologies;
(iii) Based on a standardized plan population; and
(iv) Determined without taking cost-sharing into account.
(b)
(1) May not use the AV calculator in § 156.135; and
(2) Must have the plan's actuarial value of coverage for pediatric dental essential health benefits certified by a member of the American Academy of Actuaries using generally accepted actuarial principles and reported to the Exchange.
(b) * * *
(2) Comply with Exchange processes, procedures, and requirements set forth in accordance with subpart K of part 155 of this subchapter and, in the small group market, §§ 155.705 and 155.706 of this subchapter;
(f)
(a)
(1) Accept payment from a qualified employer or an enrollee, or a SHOP on behalf of a qualified employer or enrollee, in accordance with applicable SHOP requirements.
(2) Adhere to the SHOP timeline for rate setting as established in § 155.706(b)(6) of this subchapter;
(3) Charge the same contract rate for a plan year; and
(4) Adhere to the premium rating standards described in § 147.102 of this subchapter regardless of whether the QHP being sold through the SHOP is sold in the small group market or the large group market.
(b)
(c)
(1) Provide new enrollees with the enrollment information package as described in § 156.265(e); and
(2) Enroll all qualified employees consistent with the plan year of the applicable qualified employer.
(d)
(e)
(f)
(g)
(a) * * *
(2) Exchange processes, procedures, and standards in accordance with subparts H and K of part 155 and, in the small group market, § 155.705 and § 155.706 of this subchapter;
(a) * * *
(1) Section 156.285(a)(4)(ii) regarding the premiums for plans offered on the SHOP, for plan years beginning prior to January 1, 2018;
(2) Section 156.285(c)(5) and (c)(8)(iii) regarding the enrollment process for
(b) * * *
(2) The QHP issuer must engage a third-party entity in accordance with § 155.221 of this subchapter to demonstrate operational readiness and compliance with applicable requirements prior to the QHP issuer's internet website being used to complete a QHP selection.
Title I of the Affordable Care Act, Sections 1311, 1312, 1321, 1411, 1412, Pub. L. 111-148, 124 Stat. 199.
(h)
(a)
(b)
(c)
(d)
(e)
(2) If an employer receives a determination of ineligibility to participate in the SHOP or the SHOP terminates its eligibility to participate in the SHOP, unless the SHOP notifies the issuer or issuers of the determination of ineligibility or termination of eligibility, the employer must notify the issuer or issuers of QHPs in which their group members are enrolled in coverage of its ineligibility or termination of eligibility within 5 business days of the end of any applicable appeal process under § 155.741 of this subchapter, which could include when the time to file an appeal lapses without an appeal being filed, when the appeal is rejected or dismissed, or when the appeal process concludes with an adjudication by the appeals entity, as applicable.
(3) Employers must promptly notify the issuer or issuers of QHPs in which their group members are enrolled in coverage if it wishes to terminate coverage or enrollment through the SHOP, unless the SHOP notifies the issuer or issuers.
(f)
Section 2718 of the Public Health Service Act (42 U.S.C. 300gg-18), as amended.
(b)
(b) * * *
(8) Beginning with the 2017 MLR reporting year, an issuer has the option of reporting an amount equal to 0.8 percent of earned premium in the relevant State and market in lieu of reporting the issuer's actual expenditures for activities that improve health care quality, as defined in §§ 158.150 and 158.151. If an issuer chooses this method of reporting, it must apply it for a minimum of 3 consecutive MLR reporting years and for all of its individual, small group, and large group markets; and all affiliated issuers must choose the same reporting method.
The Secretary may adjust the MLR standard that must be met by issuers offering coverage in the individual market in a State, as defined in section 2791 of the PHS Act, for a given MLR reporting year if, in the Secretary's discretion, the Secretary determines that there is a reasonable likelihood that an adjustment to the 80 percent MLR standard of section 2718(b)(1)(A)(ii) of the Public Health Service Act will help stabilize the individual market in that State.
(a) Subject to § 158.320, the State must provide, for each issuer who actively offers coverage in the individual market in the State, the following information, in accordance with paragraph (b) of this section, for
(1) Total earned premium and incurred claims;
(2) Total number of enrollees (life-years and covered lives);
(3) Total agents' and brokers' commission expenses;
(4) Net underwriting gain;
(5) Risk-based capital level; and
(6) Whether the issuer has provided notice to the State's insurance commissioner, superintendent, or comparable State authority that the issuer will cease or begin offering individual market coverage on the Exchange, certain geographic areas, or the entire individual market in the State.
(b) The information required in paragraphs (a)(1) through (4) and (6) of this section must be provided separately for the issuer's individual market plans grouped by the following categories, as applicable: On-Exchange, off-Exchange, grandfathered health plans as defined in § 147.140 of this subchapter, coverage that meets the criteria for transitional policies outlined in applicable guidance, and non-grandfathered single risk pool coverage. The information required in paragraph (a)(5) of this section must be provided at the issuer level.
(c) The State must also provide information regarding whether any issuer other than those described in paragraph (a) of this section has provided notice to the State's insurance commissioner, superintendent, or comparable State authority that the issuer will cease or begin offering individual market coverage on the Exchange, certain geographic areas, or the entire individual market in the State.
A State must provide its own proposal as to the adjustment it seeks to the MLR standard. This proposal must include an explanation of how an adjustment to the MLR standard for the State's individual market will help stabilize the State's individual market.
The Secretary may consider the following criteria in assessing whether an adjustment to the 80 percent MLR standard, as calculated in accordance with this subpart, would be reasonably likely to help stabilize the individual market in a State that has requested such adjustment:
(a) The number and financial performance (based on data provided by a State under § 158.321) of issuers actively offering individual health insurance coverage on- and off-Exchange, grandfathered health plans as defined in § 147.140 of this subchapter, coverage that meets the criteria for transitional policies outlined in applicable guidance, and non-grandfathered single risk pool coverage; the number of issuers reasonably likely to cease or begin offering individual market coverage in the State; and the likelihood that an adjustment to the 80 percent MLR standard could help increase competition in the individual market in the State, including in underserved areas.
(b) Whether an adjustment to the 80 percent MLR standard for the individual market may improve consumers' access to agents and brokers.
(c) The capacity of any new issuers or issuers remaining in the individual market to write additional business in the event one or more issuers were to cease offering individual market coverage on the Exchange, in certain geographic areas, or in the entire individual market in the State.
(d) The impact on premiums charged, and on benefits and cost sharing provided, to consumers by issuers remaining in or entering the individual market in the event one or more issuers were to cease or begin offering individual market coverage on the Exchange, in certain geographic areas, or in the entire individual market in the State.
(e) Any other relevant information submitted by the State's insurance commissioner, superintendent, or comparable official in the State's request.
A State's request for an adjustment to the MLR standard, and all information submitted as part of its request, will be treated as a public document. Instructions for how to access documents related to a State's request for an adjustment to the MLR standard will be made available on the Secretary's website.
A State that has made a previous request for an adjustment to the MLR standard must, in addition to the other information required by this subpart, submit information as to what steps the State has taken since its prior requests, if any, to improve the stability of the State's individual market.
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 |