Vol. 83 Tuesday, No. 74 April 17, 2018

Pages 16767–17076

OFFICE OF THE FEDERAL REGISTER

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Contents Federal Register Vol. 83, No. 74

Tuesday, April 17, 2018

Agency for Healthcare Research and Quality Willamette River at Portland, OR, 16774 NOTICES Willamette River, Portland, OR, 16776 Agency Information Collection Activities; Proposals, Safety Zones: Submissions, and Approvals, 16858–16860 Barge PFE–LB444, San Joaquin River, Blackslough Landing, CA, 16778–16780 Agency for International Development Recurring Marine Events, Sector Key West, FL, 16780– NOTICES 16783 Meetings: PROPOSED RULES Board for International Food and Agricultural Safety Zones: Development, 16823–16824 Coast Guard Sector Upper Mississippi River Annual and Recurring Safety Zones Update, 16811–16815 Agricultural Research Service Lower Mississippi River, New Orleans, LA, 16817–16819 NOTICES Lower Tchefuncte River, Madisonville, LA, 16815–16817 Exclusive Licenses; Approvals: Special Local Regulations: Koppert B.V. of The Netherlands, 16824 Monongahela River (MM 0.22), Allegheny River (MM 0.8), and Ohio River (0.8), Pittsburgh, PA, 16808– Agriculture Department 16811 See Agricultural Research Service See Federal Crop Insurance Corporation See Forest Service Commerce Department See International Trade Administration Bureau of Consumer Financial Protection See Patent and Trademark Office NOTICES Requests for Information: Bureau’s Consumer Complaint and Consumer Inquiry Defense Department Handling Processes, 16839–16841 See Engineers Corps RULES Bureau of Safety and Environmental Enforcement Employment of Military Resources in the Event of Civil NOTICES Disturbances, 16774 Agency Information Collection Activities; Proposals, NOTICES Submissions, and Approvals: Joint Rules of Appellate Procedure for Courts of Criminal Relief or Reduction in Royalty Rates, 16898–16899 Appeals; Proposed Changes, 16841 Well Control and Production Safety Training, 16899– 16900 Drug Enforcement Administration NOTICES Centers for Disease Control and Prevention Importers of Controlled Substances; Applications: NOTICES Clinical Supplies Management Holdings, Inc., 16901– Agency Information Collection Activities; Proposals, 16902 Submissions, and Approvals, 16860–16862

Centers for Medicare & Medicaid Services Education Department NOTICES NOTICES Medicare and Medicaid Programs: Agency Information Collection Activities; Proposals, Application from DNV GL-Healthcare for Continued Submissions, and Approvals: Approval of its Hospital Accreditation Program, Teacher Education Assistance for College and Higher 16862–16863 Education Grant Program (TEACH Grant Program) Agreement to Serve, 16841–16842 Civil Rights Commission NOTICES Meetings: Energy Department District of Columbia Advisory Committee, 16828 See Federal Energy Regulatory Commission Oregon Advisory Committee, 16826–16827 NOTICES Rhode Island Advisory Committee, 16826–16827 Agency Information Collection Activities; Proposals, West Virginia Advisory Committee, 16827–16828 Submissions, and Approvals, 16842–16843 Charter Renewals: Coast Guard Environmental Management Site-Specific Advisory RULES Board, 16842 Drawbridge Operations: Export Liquefied Natural Gas; Applications: Atlantic Intracoastal Waterway and Biscayne Bay, Miami, Sabine Pass Liquefaction, LLC, 16843–16844 FL, 16776–16778 Meetings: Hood Canal, Port Gamble, WA, 16774–16775 Environmental Management Site-Specific Advisory Board Lake Washington Ship Canal, Seattle, WA, 16775 Chairs, 16843

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Engineers Corps Federal Highway Administration RULES NOTICES Restricted Areas: Agency Information Collection Activities; Proposals, United States Air Force 81st Security Forces Anti- Submissions, and Approvals, 16913–16916 Terrorism Office, Keesler Air Force Base, Biloxi, MS, Federal Agency Actions: 16783–16784 Colorado; Proposed Highways, 16916–16918

Environmental Protection Agency Federal Motor Carrier Safety Administration NOTICES NOTICES Proposed Prospective Purchaser Agreement for the Manual Qualification of Drivers; Exemption Applications: Transmission of Muncie Site in Muncie, IN, 16853 Diabetes, 16918–16920 Requests for Nominations: Mobile Sources Technical Review Subcommittee, 16852– 16853 Federal Reserve System NOTICES Federal Aviation Administration Agency Information Collection Activities; Proposals, RULES Submissions, and Approvals, 16857–16858 Airworthiness Directives: The Boeing Company Airplanes, 16768–16773 Fish and Wildlife Service PROPOSED RULES PROPOSED RULES Airworthiness Directives: Endangered and Threatened Species: Airbus Airplanes, 16787–16792, 16799–16802 90-Day Findings for Two Species, 16819–16822 General Electric Company CF34–8E Engines, 16794– 16796 Food and Drug Administration Saab AB, Saab Aeronautics (Formerly Known as Saab AB, NOTICES Saab Aerosystems) Airplanes, 16792–16794 Agency Information Collection Activities; Proposals, The Boeing Company Airplanes, 16796–16799 Submissions, and Approvals, 16865–16866 Class E Airspace; Amendments: Agency Information Collection Activities; Proposals, Lansing, MI, 16802–16804 Submissions, and Approvals: VOR Federal Airways; Amendments: Current Good Manufacturing Practices and Related V–170 and V–219 in the Vicinity of Fairmont, MN, Regulations for Blood and Blood Components; and 16804–16806 Requirements for Donation Testing, Donor NOTICES Notification, and Lookback, 16870–16875 Meetings: Evaluation of the Fresh Empire Campaign on Tobacco, Eighty Eighth RTCA SC–147 Plenary Session Joint with 16863–16865 EUROCAE WG–75, 16913 Guidance: Listing of Ingredients in Tobacco Products, 16866–16867 Federal Communications Commission Meetings: NOTICES Advisory Committees; Filing of Closed Meeting Reports, Agency Information Collection Activities; Proposals, 16867–16868 Submissions, and Approvals, 16853–16857 Pilot Program for Model-Informed Drug Development Meetings, 16855–16856 Approaches, 16868–16870 Federal Crop Insurance Corporation RULES Forest Service Common Crop Insurance Regulations: NOTICES California Avocado Crop Insurance Provisions, 16767– Agency Information Collection Activities; Proposals, 16768 Submissions, and Approvals: Cultivated Clam Crop Insurance Provisions, 16767 Forest Products Removal Permits and Contracts, 16824– 16826 Federal Energy Regulatory Commission Settlements Pursuant to CERCLA: NOTICES Libby Asbestos Site, Lincoln County, MT, 16824 Combined Filings, 16847, 16850–16851 Environmental Assessments; Availability, etc.: Health and Human Services Department Empire North Project, 16847–16849 See Agency for Healthcare Research and Quality Initial Market-Based Rate Filings Including Requests for See Centers for Disease Control and Prevention Blanket Section 204 Authorizations: See Centers for Medicare & Medicaid Services Calpine Mid-Merit II, LLC, 16851–16852 See Food and Drug Administration Wheelabrator Millbury Inc., 16852 See Health Resources and Services Administration Meetings: See Indian Health Service Commissioner Attendance at House Committee on Energy See National Institutes of Health and Commerce Hearing, 16844 RULES Supplemental Notice of Technical Conference, 16845– Patient Protection and Affordable Care Act: 16847 Benefit and Payment Parameters for 2019, 16930–17071 Meetings; Sunshine Act, 16849–16850 NOTICES Petitions for Declaratory Order: Meetings: Marathon Pipe Line LLC, MPLX Ozark Pipe Line LLC, National Committee on Vital and Health Statistics, 16847 16876–16877

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Health Resources and Services Administration Agency Information Collection Activities; Proposals, NOTICES Submissions, and Approvals: Meetings: Application for Registration, Application for Registration Advisory Committee on Training in Primary Care Renewal, 16902 Medicine and Dentistry, 16875–16876 Application for Registration, Application for Registration Renewal, Affidavit for Chain Renewal, 16903–16904 Homeland Security Department See Coast Guard Legal Services Corporation See U.S. Customs and Border Protection RULES State Advisory Councils, 16785–16786 Housing and Urban Development Department NOTICES National Institutes of Health Agency Information Collection Activities; Proposals, NOTICES Submissions, and Approvals: Meetings: Energy Efficient Mortgages, 16897 National Institute of Allergy and Infectious Diseases, Mortgagor’s Certificate of Actual Cost, 16896–16897 16892–16893 Redelegation of Authority to the General Deputy Assistant National Institute of Dental and Craniofacial Research, Secretary for Administration, 16897–16898 16893 Task Force on Research Specific to Pregnant Women and Indian Affairs Bureau Lactating Women, 16893–16894 PROPOSED RULES Committee Establishment; Proposed Memberships: National Science Foundation Bureau of Indian Education Standards, Assessments, and NOTICES Accountability System Negotiated Rulemaking Agency Information Collection Activities; Proposals, Committee, 16806–16808 Submissions, and Approvals, 16905

Indian Health Service Nuclear Regulatory Commission NOTICES NOTICES Negotiation Cooperative Agreement, 16877–16885 Meetings: Office of Tribal Self-Governance; Planning Cooperative ACRS Subcommittee on Reliability and Probabilistic Risk Agreement, 16885–16892 Assessment, 16905–16906 Advisory Committee on Reactor Safeguards Interior Department Subcommittee on Planning and Procedures, 16906 See Bureau of Safety and Environmental Enforcement See Fish and Wildlife Service Parole Commission See Indian Affairs Bureau NOTICES Meetings; Sunshine Act, 16904 Internal Revenue Service NOTICES Agency Information Collection Activities; Proposals, Patent and Trademark Office Submissions, and Approvals, 16920–16921 NOTICES Agency Information Collection Activities; Proposals, International Trade Administration Submissions, and Approvals: Public Key Infrastructure Certificate Action Form, 16833– NOTICES Antidumping or Countervailing Duty Investigations, Orders, 16834 or Reviews: Public Search Facility User ID and Badging, 16834 Aluminum Extrusions from the People’s Republic of Third-Party Submissions and Protests, 16836–16839 China, 16828–16829 Trademark Petitions, 16835–16836 Carbon and Certain Alloy Steel Wire Rod from Mexico, 16832–16833 Presidential Documents Certain New Pneumatic Off-the-Road Tires from the PROCLAMATIONS People’s Republic of China, 16829–16832 Special Observances: Pan American Day and Pan American Week (Proc. 9725), International Trade Commission 17073–17076 NOTICES Investigations; Determinations, Modifications, and Rulings, Securities and Exchange Commission etc.: NOTICES U.S.-Korea Free Trade Agreement: Advice on Agency Information Collection Activities; Proposals, Modifications to Duty Rates for Certain Motor Submissions, and Approvals, 16908–16909 Vehicles, 16900–16901 Meetings; Sunshine Act, 16906 Self-Regulatory Organizations; Proposed Rule Changes: Justice Department Nasdaq PHLX LLC, 16907–16908 See Drug Enforcement Administration NYSE Arca, Inc., 16909–16912 See Parole Commission NOTICES Surface Transportation Board Agency Information Collection Activities; Proposals, RULES Submissions, and Approvals, 16903 Updating the Code of Federal Regulations, 16786

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NOTICES Pulmonary Health and Deployment to Southwest Asia Lease and Operation Exemptions: and Afghanistan, 16921–16922 JP Rail, Inc. d/b/a Southern Railroad Co. of New Jersey; Request for Change of Program or Place of Training, Consolidated Rail Corp., 16913 16924 VA Health Professional Scholarship and Visual Transportation Department Impairment and Orientation and Mobility See Federal Aviation Administration Professional Scholarship Programs, 16925–16927 See Federal Highway Administration VBA Call Center Satisfaction Survey, 16922 See Federal Motor Carrier Safety Administration Programmatic Consideration of Historic Properties in Treasury Department Transfer of Property Rights of Vacant and See Internal Revenue Service Underutilized Buildings, Structures and Land, 16923– NOTICES 16924 Agency Information Collection Activities; Proposals, Submissions, and Approvals, 16857–16858 U.S. Customs and Border Protection Separate Parts In This Issue NOTICES Agency Information Collection Activities; Proposals, Part II Submissions, and Approvals: Health and Human Services Department, 16930–17071 Entry/Immediate Delivery Application and ACE Cargo Release, 16895–16896 Commercial Gaugers and Laboratories; Accreditations and Part III Approvals: Presidential Documents, 17073–17076 Camin Cargo Control, Inc., 16894 Commercial Gaugers; Accreditations and Approvals: Intertek USA, Inc., 16894–16895 Reader Aids Veterans Affairs Department Consult the Reader Aids section at the end of this issue for phone numbers, online resources, finding aids, and notice NOTICES Agency Information Collection Activities; Proposals, of recently enacted public laws. Submissions, and Approvals: To subscribe to the Federal Register Table of Contents Application and Reporting Requirements to Receive electronic mailing list, go to https://public.govdelivery.com/ Grants, 16924–16925 accounts/USGPOOFR/subscriber/new, enter your e-mail Federal Medical Care Recovery Act Bill Requests, 16922– address, then follow the instructions to join, leave, or 16923 manage your subscription.

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CFR PARTS AFFECTED IN THIS ISSUE

A cumulative list of the parts affected this month can be found in the Reader Aids section at the end of this issue.

3 CFR 1146...... 16786 1147...... 16786 Proclamations: 1150...... 16786 9725...... 17075 1152...... 16786 7 CFR 1155...... 16786 457 (2 documents) ...... 16767 1177...... 16786 14 CFR 1180...... 16786 39...... 16768 1182...... 16786 1184...... 16786 Proposed Rules: 1185...... 16786 39 (5 documents) ...... 16787, 1200...... 16786 16792, 16794, 16796, 16799 1220...... 16786 71 (2 documents) ...... 16802, 1242...... 16786 16804 1243...... 16786 1244...... 16786 25 CFR 1245...... 16786 Proposed Rules: 1246...... 16786 30...... 16806 1247...... 16786 32 CFR 1248...... 16786 215...... 16774 1253...... 16786 1305...... 16786 33 CFR 1310...... 16786 117 (5 documents) ...... 16774, 1312...... 16786 16775, 16776 1313...... 16786 165 (2 documents) ...... 16778, 1319...... 16786 16780 1331...... 16786 334...... 16783 1333...... 16786 Proposed Rules: 50 CFR 100...... 16808 Proposed Rules: 165 (3 documents) ...... 16811, 17...... 16819 16815, 16817 45 CFR 147...... 16930 153...... 16930 154...... 16930 155...... 16930 156...... 16930 157...... 16930 158...... 16930 1603...... 16785 49 CFR 1001...... 16786 1003...... 16786 1004...... 16786 1005...... 16786 1007...... 16786 1011...... 16786 1012...... 16786 1013...... 16786 1016...... 16786 1018...... 16786 1019...... 16786 1033...... 16786 1034...... 16786 1035...... 16786 1037...... 16786 1090...... 16786 1100...... 16786 1101...... 16786 1103...... 16786 1104...... 16786 1105...... 16786 1106...... 16786 1108...... 16786 1110...... 16786 1112...... 16786 1113...... 16786 1114...... 16786 1116...... 16786 1117...... 16786 1119...... 16786 1120...... 16786 1132...... 16786 1133...... 16786 1135...... 16786 1141...... 16786 1144...... 16786

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Rules and Regulations Federal Register Vol. 83, No. 74

Tuesday, April 17, 2018

This section of the FEDERAL REGISTER no program integrity issues. Once the California Avocado Crop Insurance contains regulatory documents having general pilot program is completed, evaluated, Provisions which published in the applicability and legal effect, most of which and approved for permanence, the Federal Register on December 27, 2017. are keyed to and codified in the Code of restriction on written agreements is no DATES: Effective Date: April 17, 2018. Federal Regulations, which is published under longer necessary. As a result of the 50 titles pursuant to 44 U.S.C. 1510. FOR FURTHER INFORMATION CONTACT: Ron removal of section 15, FCIC is allowing Lundine, Director, Product The Code of Federal Regulations is sold by the use of written agreements under the Management, Actuarial and Product the Superintendent of Documents. cultivated clam crop provisions and Design Division, Risk Management redesignating subtitle numbering from Agency, United States Department of section 16 to section 15, section 17 to Agriculture, Beacon Facility, Stop 0812, DEPARTMENT OF AGRICULTURE section 16, and section 18 to section 17. Room 421, P.O. Box 419205, Kansas Federal Crop Insurance Corporation List of Subjects in 7 CFR Part 457 City, MO 64141–6205, telephone (816) 926–3854. Crop insurance, Cultivated clam, SUPPLEMENTARY INFORMATION: 7 CFR Part 457 Reporting and recordkeeping [Docket No. FCIC–17–0003] requirements. Background Accordingly, 7 CFR part 457 is RIN 0563–AC59 This technical correction is being corrected by making the following published to remove section 13 of the Common Crop Insurance Regulations; amendments: ‘‘California avocado crop insurance Cultivated Clam Crop Insurance provisions,’’ published December 27, PART 457—COMMON CROP Provisions 2017 (Docket No. FCIC–17–0002). INSURANCE REGULATIONS Section 13 excludes the use of written AGENCY: Federal Crop Insurance agreements by not allowing the written Corporation, USDA. ■ 1. The authority citation for 7 CFR part 457 continues to read as follows: agreement provisions in the Common ACTION: Final rule with request for Crop Insurance Policy Basic Provisions comments; correcting amendment. Authority: 7 U.S.C. 1506(l) and 1506(o). to apply. This provision was necessary when the program was a pilot program SUMMARY: This document contains § 457.176 [Amended] to ensure there were no changes made necessary amendments to apply a ■ 2. Amend § 457.176, in the cultivated technical correction to the final rule to the policy so that the existing terms clam crop insurance provisions, by would be evaluated to make sure they with request for comments for the removing section 15 and redesignating Cultivated Clam Crop Insurance were actuarially sound and there were sections 16 through 18 as sections 15 no program integrity issues. Once the Provisions which published in the through section 17. Federal Register on December 27, 2017. pilot program is completed, evaluated, Signed in Washington, DC, on April 12, and approved for permanence, the DATES: Effective Date: April 17, 2018. 2018. restriction on written agreements is no FOR FURTHER INFORMATION CONTACT: Ron Heather Manzano, longer necessary. As a result of the Lundine, Director, Product Acting Manager, Federal Crop Insurance removal of section 13, FCIC is allowing Management, Actuarial and Product Corporation. the use of written agreements under the Design Division, Risk Management [FR Doc. 2018–08017 Filed 4–16–18; 8:45 am] California avocado crop provisions and Agency, United States Department of BILLING CODE 3410–08–P redesignating subtitle numbering from Agriculture, Beacon Facility, Stop 0812, section 14 to section 13. Room 421, P.O. Box 419205, Kansas City, MO 64141–6205, telephone (816) DEPARTMENT OF AGRICULTURE List of Subjects in 7 CFR Part 457 926–3854. Crop insurance, California avocado, SUPPLEMENTARY INFORMATION: Federal Crop Insurance Corporation Reporting and recordkeeping requirements. Background 7 CFR Part 457 Accordingly, 7 CFR part 457 is This technical correction is being [Docket No. FCIC–17–0002] corrected by making the following published to remove section 15 of the amendments: ‘‘cultivated clam crop insurance RIN 0563–AC58 provisions,’’ published December 27, PART 457—COMMON CROP 2017 (Docket No. FCIC–17–0003). Common Crop Insurance Regulations; INSURANCE REGULATIONS Section 15 excludes the use of written California Avocado Crop Insurance agreements by not allowing the written Provisions ■ 1. The authority citation for part 457 agreement provisions in the Common AGENCY: Federal Crop Insurance continues to read as follows: Crop Insurance Policy Basic Provisions Corporation, USDA. Authority: 7 U.S.C. 1506(l) and 1506(o). to apply. This provision was necessary ACTION: Correcting amendment. when the program was a pilot program § 457.175 [Amended] to ensure there were no changes made SUMMARY: This document contains ■ 2. Amend § 457.175, in the California to the policy so that the existing terms necessary amendments to apply a avocado crop provisions, by removing would be evaluated to make sure they technical correction to the final rule section 13 and redesignating section 14 were actuarially sound and there were with request for comments for the as section 13.

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Signed in Washington, DC, on April 12, p.m., Monday through Friday, except condition. Therefore, an ETOPS 2018. Federal holidays. diversion will put the remaining engine Heather Manzano, at an operating condition that would Examining the AD Docket Acting Manager, Federal Crop Insurance significantly increase the likelihood of Corporation. You may examine the AD docket on failure of the remaining engine. In [FR Doc. 2018–08016 Filed 4–16–18; 8:45 am] the internet at http:// addition, if the remaining engine BILLING CODE 3410–08–P www.regulations.gov by searching for already had cracked IPC stage 2 blades, and locating Docket No. FAA–2018– the likelihood of the remaining engine 0299; or in person at Docket Operations failing will further increase before a DEPARTMENT OF TRANSPORTATION between 9 a.m. and 5 p.m., Monday diversion can be safely completed. through Friday, except Federal holidays. FAA’s Determination Federal Aviation Administration The AD docket contains this final rule, the regulatory evaluation, any We are issuing this AD because we 14 CFR Part 39 comments received, and other evaluated all the relevant information information. The street address for and determined the unsafe condition [Docket No. FAA–2018–0299; Product Docket Operations (phone: 800–647– Identifier 2018–NM–060–AD; Amendment described previously is likely to exist or 39–19256; AD 2018–08–03] 5527) is in the ADDRESSES section. develop in other products of the same Comments will be available in the AD type design. RIN 2120–AA64 docket shortly after receipt. AD Requirements FOR FURTHER INFORMATION CONTACT: Airworthiness Directives; The Boeing Tak Company Airplanes Kobayashi, Aerospace Engineer, This AD requires revising the AFM to Propulsion Section, FAA, Seattle ACO limit ETOPS operation. AGENCY: Federal Aviation Branch, 2200 South 216th Street, Des Interim Action Administration (FAA), DOT. Moines, WA 98198; phone and fax: 206– ACTION: Final rule; request for 231–3553; email: Takahisa.Kobayashi@ This AD is interim action. The comments. faa.gov. manufacturer is currently developing a SUPPLEMENTARY INFORMATION: modification that will address the SUMMARY: We are adopting a new unsafe condition identified in this AD. airworthiness directive (AD) for The Discussion Once this modification is developed, Boeing Company Model 787–8 and 787– Over the past year, we have been approved, and available, we might 9 airplanes powered by Rolls-Royce plc aware of several engine failures of Trent consider additional rulemaking. (RR) Trent 1000–A2, Trent 1000–AE2, 1000 Package C engines due to failed Trent 1000–C2, Trent 1000–CE2, Trent FAA’s Justification and Determination compressor and turbine blades and of the Effective Date 1000–D2, Trent 1000–E2, Trent 1000– seals. Package C engines are Rolls-Royce G2, Trent 1000–H2, Trent 1000–J2, plc (RR) Trent 1000–A2, Trent 1000– An unsafe condition exists that Trent 1000–K2, and Trent 1000–L2 AE2, Trent 1000–C2, Trent 1000–CE2, requires the immediate adoption of this turbofan engines. This AD requires Trent 1000–D2, Trent 1000–E2, Trent AD without providing an opportunity revising the airplane flight manual to 1000–G2, Trent 1000–H2, Trent 1000– for public comments prior to adoption. limit extended operations (ETOPS). This J2, Trent 1000–K2, and Trent 1000–L2 The FAA has found that the risk to the AD was prompted by a report from the turbofan engines. During that same flying public justifies waiving notice engine manufacturer indicating that period, under the management programs and comment prior to adoption of this after an engine failure, prolonged for those engine issues, we have been rule because unrecoverable thrust loss operation at high thrust settings on the aware of numerous reports of engine on both engines could lead to a forced remaining engine during an ETOPS inspection findings of cracked blades landing. Therefore, we find good cause diversion may result in failure of the resulting in unscheduled engine that notice and opportunity for prior remaining engine before the diversion removals. Boeing reported to the FAA public comment are impracticable. In can be safely completed. We are issuing that the engine manufacturer recently addition, for the reasons stated above, this AD to address the unsafe condition determined that intermediate pressure we find that good cause exists for on these products. compressor (IPC) stage 2 blades have a making this amendment effective in less DATES: This AD is effective April 17, resonant frequency that is excited by the than 30 days. 2018. airflow conditions existing in the engine Comments Invited We must receive comments on this during operation at high thrust settings AD by June 1, 2018. under certain temperature and altitude This AD is a final rule that involves ADDRESSES: You may send comments, conditions. The resultant blade requirements affecting flight safety and using the procedures found in 14 CFR vibration can result in cumulative was not preceded by notice and an 11.43 and 11.45, by any of the following fatigue damage that can cause blade opportunity for public comment. methods: failure and consequent engine However, we invite you to send any • Federal eRulemaking Portal: Go to shutdown. In the event of a single written data, views, or arguments about http://www.regulations.gov. Follow the engine in-flight shutdown during the this final rule. Send your comments to instructions for submitting comments. cruise phase of flight, thrust on the an address listed under the ADDRESSES • Fax: 202–493–2251. remaining engine is normally increased section. Include the docket number • Mail: U.S. Department of to maximum continuous thrust (MCT). FAA–2018–0299 and Product Identifier Transportation, Docket Operations, M– During a diversion following a single 2018–NM–060–AD at the beginning of 30, West Building Ground Floor, Room engine shutdown under an ETOPS your comments. We specifically invite W12–140, 1200 New Jersey Avenue SE, flight, the remaining engine may operate comments on the overall regulatory, Washington, DC 20590. at MCT for a prolonged period, under economic, environmental, and energy • Hand Delivery: Deliver to Mail which the IPC stage 2 blades would be aspects of this final rule. We will address above between 9 a.m. and 5 exposed to the resonant frequency consider all comments received by the

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closing date and may amend this final personal information you provide. We Costs of Compliance rule because of those comments. will also post a report summarizing each We estimate that this AD affects 14 We will post all comments we substantive verbal contact we receive airplanes of U.S. registry. We estimate receive, without change, to http:// about this final rule. the following costs to comply with this www.regulations.gov, including any AD:

ESTIMATED COSTS

Cost per Cost on U.S. Action Labor cost Parts cost product operators

AFM revisions ...... 1 work-hour × $85 per hour = $85 ...... $0 $85 $1,190

Authority for This Rulemaking responsibilities among the various (c) Applicability Title 49 of the United States Code levels of government. This AD applies to The Boeing Company For the reasons discussed above, I specifies the FAA’s authority to issue Model 787–8 and 787–9 airplanes, certify that this AD: rules on aviation safety. Subtitle I, certificated in any category, powered by (1) Is not a ‘‘significant regulatory Rolls-Royce plc (RR) Trent 1000–A2, Trent section 106, describes the authority of action’’ under Executive Order 12866, 1000–AE2, Trent 1000–C2, Trent 1000–CE2, the FAA Administrator. ‘‘Subtitle VII: (2) Is not a ‘‘significant rule’’ under Trent 1000–D2, Trent 1000–E2, Trent 1000– Aviation Programs’’ describes in more DOT Regulatory Policies and Procedures G2, Trent 1000–H2, Trent 1000–J2, Trent detail the scope of the Agency’s (44 FR 11034, February 26, 1979), 1000–K2, and Trent 1000–L2 turbofan authority. (3) Will not affect intrastate aviation engines. We are issuing this rulemaking under in Alaska, and (d) Subject the authority described in Subtitle VII, (4) Will not have a significant Part A, Subpart III, Section 44701: Air Transport Association (ATA) of economic impact, positive or negative, America Code 71, Power plant. ‘‘General requirements.’’ Under that on a substantial number of small entities section, Congress charges the FAA with under the criteria of the Regulatory (e) Unsafe Condition promoting safe flight of civil aircraft in Flexibility Act. This AD was prompted by a report from air commerce by prescribing regulations the engine manufacturer indicating that after for practices, methods, and procedures List of Subjects in 14 CFR Part 39 an engine failure, prolonged operation at the Administrator finds necessary for Air transportation, Aircraft, Aviation high thrust settings on the remaining engine safety in air commerce. This regulation safety, Incorporation by reference, during an extended-operation (ETOPS) is within the scope of that authority Safety. diversion may result in failure of the because it addresses an unsafe condition remaining engine before the diversion can be that is likely to exist or develop on Adoption of the Amendment safely completed. We are issuing this AD to products identified in this rulemaking Accordingly, under the authority address unrecoverable thrust loss on both delegated to me by the Administrator, engines, which could lead to a forced action. landing. This AD is issued in accordance with the FAA amends 14 CFR part 39 as authority delegated by the Executive follows: (f) Compliance Director, Aircraft Certification Service, Comply with this AD within the as authorized by FAA Order 8000.51C. PART 39—AIRWORTHINESS compliance times specified, unless already In accordance with that order, issuance DIRECTIVES done. of ADs is normally a function of the ■ 1. The authority citation for part 39 (g) Revision of Limitations Chapter in Compliance and Airworthiness continues to read as follows: Airplane Flight Manual (AFM) Division, but during this transition Within 3 days after the effective date of Authority: 49 U.S.C. 106(g), 40113, 44701. period, the Executive Director has this AD, revise the Certificate Limitations delegated the authority to issue ADs § 39.13 [Amended] chapter of the applicable Boeing AFM Engine applicable to transport category Appendix by incorporating the information ■ airplanes and associated appliances to 2. The FAA amends § 39.13 by adding in figure 1 to paragraph (g) of this AD. Where the Director of the System Oversight the following new airworthiness figure 1 to paragraph (g) of this AD refers to Division. directive (AD): a ‘‘Trent 1000 2 engine,’’ this term means all 2018–08–03 The Boeing Company: engines identified in paragraph (c) of this Regulatory Findings Amendment 39–19256; Docket No. AD. This may be accomplished by inserting This AD will not have federalism FAA–2018–0299; Product Identifier a copy of this AD into the AFM. When implications under Executive Order 2018–NM–060–AD. information identical to that in figure 1 to paragraph (g) of this AD has been included 13132. This AD will not have a (a) Effective Date in the Certificate Limitations chapter of the substantial direct effect on the States, on This AD is effective April 17, 2018. general revisions of the AFM, the general the relationship between the national revisions may be inserted into the AFM, and government and the States, or on the (b) Affected ADs the copy of this AD may be removed from the distribution of power and None. AFM.

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(h) Revision of Performance Chapter of AFM incorporating the information in figure 2 to chapter of the general revisions of the AFM, Concurrently with accomplishment of the paragraph (h) of this AD. This may be the general revisions may be inserted into the accomplished by inserting a copy of this AD requirements of paragraph (g) of this AD, AFM, and the copy of this AD may be into the AFM. When information identical to removed from the AFM. revise the Performance chapter of the that in figure 2 to paragraph (h) of this AD applicable Boeing AFM Engine Appendix by has been included in the Performance BILLING CODE 4910–13–P

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Figure 2 to paragraph (h) of this AD - AFM Performance

Engine Appendix - Performance

ETOPS

ETOPS operation of a Model 787-8 or 787-9 airplane equipped with a RR Trent 1000 A2, C2, or E2 series engine is prohibited.

As outlined in the ETOPs Section of the Certificate Limitations Chapter, the following table must be utilized when planning ETOPS flights.

D631Z003-9R64EF) 787-9 Trent 1000-AE2 Enroute Diversion Temperature ISA+O Degrees C and Below I SA+ 10 Degrees C I SA+ 15 Degrees C ISA+20 Degrees C ISA+25 Degrees C Above ISA+25 Degrees C Minimum Engine-Out Cruise 19,000 19,000 18,800 18,500 18,300 Prohibited Altitude (ft) Maximum Planned Weight at LBS 499,000 497,400 477,500 453,000 428,400 ETOPS Entry Point without Prohibited Forecast Icing KGS 226,360 225,650 216,620 205,480 194,350 Maximum Planned Weight at LBS 425,900 417,000 396,300 367,300 338,200 ETOPS Entry Point with Prohibited Forecast Icing KGS 193,210 189,170 179,800 166,610 153,420

(D631Z003-9R7072F) and (D631Z003- 9R7072E) 787-9 Trent 1000-D2 Enroute Diversion Temperature ISA+O Degrees C and Below ISA+lO Degrees C ISA+lS Degrees C ISA+20 Degrees C ISA+25 Degrees C Above ISA+25 Degrees C Minimum Engine-Out Cruise 19,100 19,100 18,900 18,700 18,500 Prohibited Altitude (ft) Maximum Planned Weight at LBS 510,300 508,400 488,200 465,800 443,400 ETOPS Entry Point without Prohibited Forecast Icing KGS 231,500 230,640 221,480 211,310 201,130 Maximum Planned Weight at LBS 438,300 429,300 408,400 383,800 359,300 ETOPS Entry Point with Prohibited Forecast lei ng KGS 198,830 194,760 185,240 174,110 162,970

(D631Z003-9R74F) and (D631Z003-9R74E) 787-9 Trent 1000-J2 Enroute Diversion Temperature I ISA+O Degrees C and Below ISA+lO Degrees C ISA+lS Degrees C ISA+20 Degrees C ISA+25 Degrees C Above ISA+25 Degrees C Minimum Engine-Out Cruise 19,300 19,300 19,100 18,800 18,500 Prohibited Altitude (ft) Maximum Planned Weight at LBS 530,400 527,800 507,800 479,500 451,100 ETOPS Entry Point without Prohibited Forecast lei ng KGS 240,600 239,430 230,370 217,510 204,640 Maximum Planned Weight at LBS 455,200 446,600 430,200 401,400 372,500 ETOPS Entry Point with Prohibited Forecast Icing KGS 206,470 202,580 195,140 182,070 169,000

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(D631Z003-R7475F) and (D631Z003-R7475E 787-9 Trent 1000-K2 Enroute Diversion Temperature ISA+O Degrees C and Below ISA+lO Degrees C ISA+lS Degrees C ISA+20 Degrees C ISA+25 Degrees C Above ISA+25 Degrees C Minimum Engine-Out Cruise 19,300 19,300 19,100 18,800 18,500 Prohibited Altitude (ft) Maximum Planned Weight at LBS 530,400 527,800 507,800 479,500 451,100 ETOPS Entry Point without Prohibited Forecast Icing KGS 240,600 239,430 230,370 217,510 204,640 Maximum Planned Weight at LBS 455,200 446,600 430,200 401,400 372,500 ETOPS Entry Point with Prohibited Forecast Icing KGS 206,470 202,580 195,140 182,070 169,000

D631Z003-R70EF) 787-8 Trent 1000-CE2 Enroute Diversion Temperature

ISA+O Degrees C and Below ISA+lO Degrees C ISA+lS Degrees C ISA+20 Degrees C ISA+25 Degrees C Above ISA+25 Degrees C

Minimum Engine-Out Cruise 19,300 19,300 19,100 18,900 18,600 Prohibited Altitude (ft)

Maximum Planned Weight at LBS 525,100 523,100 501,400 476,300 451,100 ETOPS Entry Point without Prohibited Forecast Icing KGS 238,200 237,310 227,450 216,040 204,630 Maximum Planned Weight at LBS 446,700 438,600 419,400 396,300 373,300 ETOPS Entry Point with Prohibited Forecast Icing KGS 202,650 198,970 190,260 179,790 169,330

D631Z003-R7072F) and (D631Z003-R7072E) 787-8 Trent 1000-D2 Enroute Diversion Temperature

ISA+O Degrees C and Below I SA+ 10 Degrees C ISA+ 15 Degrees C ISA+20 Degrees C ISA+25 Degrees C Above ISA+25 Degrees C

Minimum Engine-Out Cruise 19,300 19,300 19,100 18,900 18,600 Prohibited Altitude (ft)

Maximum Planned Weight at LBS 525,100 523,100 501,400 476,300 451,100 ETOPS Entry Point without Prohibited Forecast Icing KGS 238,200 237,310 227,450 216,040 204,630 Maximum Planned Weight at LBS 446,700 438,600 419,400 396,300 373,300 ETOPS Entry Point with Prohibited Forecast Icing KGS 202,650 198,970 190,260 179,790 169,330

D631Z003-R70LF) 787-8 Trent 1000-L2 Enroute Diversion Temperature

ISA+O Degrees C and Below I SA+ 10 Degrees C ISA+ 15 Degrees C ISA+20 Degrees C ISA+25 Degrees C Above ISA+25 Degrees C

Minimum Engine-Out Cruise 19,300 19,300 19,100 18,900 18,600 Prohibited Altitude (ft)

Maximum Planned Weight at LBS 525,100 523,100 501,400 476,300 451,100 ETOPS Entry Point without Prohibited Forecast Icing KGS 238,200 237,310 227,450 216,040 204,630 Maximum Planned Weight at LBS 446,700 438,600 419,400 396,300 373,300 ETOPS Entry Point with Prohibited Forecast Icing KGS 202,650 198,970 190,260 179,790 169,330

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BILLING CODE 4910–13–C of the local flight standards district office/ Moines, WA 98198; phone and fax: 206–231– (i) Alternative Methods of Compliance certificate holding district office. 3553; email: [email protected]. (AMOCs) (3) An AMOC that provides an acceptable level of safety may be used for any repair, (k) Material Incorporated by Reference (1) The Manager, Seattle ACO Branch, modification, or alteration required by this None. FAA, has the authority to approve AMOCs AD if it is approved by the Boeing for this AD, if requested using the procedures Commercial Airplanes Organization Issued in Des Moines, Washington, on found in 14 CFR 39.19. In accordance with Designation Authorization (ODA) that has April 12, 2018. 14 CFR 39.19, send your request to your been authorized by the Manager, Seattle ACO Jeffrey E. Duven, principal inspector or local Flight Standards Branch, to make those findings. To be approved, the repair method, modification Director, System Oversight Division, Aircraft District Office, as appropriate. If sending Certification Service. information directly to the manager of the deviation, or alteration deviation must meet the certification basis of the airplane, and the [FR Doc. 2018–08127 Filed 4–16–18; 8:45 am] certification office, send it to the attention of approval must specifically refer to this AD. the person identified in paragraph (j) of this BILLING CODE 4910–13–P AD. Information may be emailed to: 9-ANM- (j) Related Information [email protected]. For more information about this AD, (2) Before using any approved AMOC, contact Tak Kobayashi, Aerospace Engineer, notify your appropriate principal inspector, Propulsion Section, FAA, Seattle ACO or lacking a principal inspector, the manager Branch, 2200 South 216th Street, Des

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DEPARTMENT OF DEFENSE Dated: April 12, 2018. above Columbia River Datum 0.0. The Shelly E. Finke, normal operating schedule for these Office of the Secretary Alternate OSD Federal Register Liaison bridges is 33 CFR 117.897. This Officer, Department of Defense. deviation allows the Broadway Bridge, 32 CFR Part 215 [FR Doc. 2018–08004 Filed 4–16–18; 8:45 am] Morrison Bridge, and the Hawthorne [Docket ID: DOD–2017–OS–0056] BILLING CODE 5001–06–P Bridge to remain in the closed-to- navigation position, and need not open RIN 0790–AK07 for maritime traffic from 8 a.m. to 9:15 a.m. on May 6, 2018. Employment of Military Resources in DEPARTMENT OF HOMELAND the Event of Civil Disturbances SECURITY Waterway usage on this part of the Willamette River includes vessels AGENCY: Under Secretary of Defense for Coast Guard ranging from commercial tug and barge Policy, DoD. to small pleasure craft. Vessels able to ACTION: Final rule. 33 CFR Part 117 pass through the subject bridges in the [Docket No. USCG–2018–0326] closed-to-navigation position may do so SUMMARY: This final rule removes the at any time. The bridges will be able to Department of Defense (DoD) regulation Drawbridge Operation Regulation; open for emergencies, and there is no regarding employment of military Willamette River at Portland, OR immediate alternate route for vessels to resources in the event of civil pass. The Coast Guard will inform the disturbances. The part contains uniform AGENCY: Coast Guard, DHS. users of the waterway, through our DoD policies, assigns responsibilities, ACTION: Notice of deviation from Local and Broadcast Notices to and furnishes general guidance for drawbridge regulation. Mariners, of the change in operating utilizing DoD military and civilian schedule for the bridges so that vessels SUMMARY: personnel, facilities, equipment, or The Coast Guard has issued a can arrange their transits to minimize supplies in support of civil authorities temporary deviation from the operating any impact caused by the temporary during civil disturbances within the schedule that governs three Multnomah deviation. In accordance with 33 CFR United States. This part is outdated and County bridges: Broadway Bridge, mile 117.35(e), the drawbridges must return unnecessary; therefore, it may be 11.7, Morrison Bridge, mile 12.8, and to their regular operating schedules removed from the CFR. Hawthorne Bridge, mile 13.1 crossing immediately at the end of the effective DATES: This rule is effective on April 17, the Willamette River at Portland, OR. period of this temporary deviation. This 2018. This deviation is necessary to deviation from the operating regulations FOR FURTHER INFORMATION CONTACT: accommodate the annual Cinco de Mayo is authorized under 33 CFR 117.35. James (Coach) Ross at 571–256–8325. half marathon event. The deviation allows the bridges to remain in the Dated: April 10, 2018. SUPPLEMENTARY INFORMATION: It has been Steven M. Fischer, determined that publication of this CFR closed-to-navigation position. part removal for public comment is DATES: This deviation is effective from Bridge Administrator, Thirteenth Coast Guard District. impracticable, unnecessary, and 8 a.m. to 9:15 a.m. on May 6, 2018. contrary to public interest since it is ADDRESSES: The docket for this [FR Doc. 2018–07959 Filed 4–16–18; 8:45 am] based on removing DoD internal deviation, USCG–2018–0326 is available BILLING CODE 9110–04–P policies and procedures that are at http://www.regulations.gov. Type the publicly available on the Department’s docket number in the ‘‘SEARCH’’ box and click ‘‘SEARCH.’’ Click on Open DEPARTMENT OF HOMELAND issuance website. SECURITY DoD internal guidance regarding Docket Folder on the line associated employment of military resources in the with this deviation. Coast Guard event of civil disturbances will continue FOR FURTHER INFORMATION CONTACT: If to be published in DoD Instruction you have questions on this temporary 33 CFR Part 117 3025.21, ‘‘Defense Support of Civilian deviation, call or email Mr. Steven Law Enforcement Agencies,’’ available Fischer, Bridge Administrator, [Docket No. USCG–2018–0299] at http://www.esd.whs.mil/Portals/54/ Thirteenth Coast Guard District; Documents/DD/issuances/dodi/ telephone 206–220–7282, email d13-pf- Drawbridge Operation Regulation; 302521p.pdf. [email protected]. Hood Canal, Port Gamble, WA This rule is not significant under SUPPLEMENTARY INFORMATION: Executive Order (E.O.) 12866, Multnomah County, the bridge owner, AGENCY: Coast Guard, DHS. ‘‘Regulatory Planning and Review,’’ has requested a temporary deviation ACTION: Notice of deviation from therefore, E.O. 13771, ‘‘Reducing from the operating schedule for the drawbridge regulation. Regulation and Controlling Regulatory Broadway Bridge, mile 11.7, Morrison Costs’’ does not apply. Bridge, mile 12.8, and Hawthorne SUMMARY: The Coast Guard has issued a List of Subjects in 32 CFR Part 215 Bridge, mile 13.1, all three crossing the temporary deviation from the operating Willamette River at Portland, OR. The schedule that governs the Washington Armed forces, Civil disorders, requested deviation is to accommodate State pontoon highway bridge (Hood Emergency powers, Intergovernmental the annual Cinco de Mayo half Canal Bridge) across Hood Canal, mile relations, Law enforcement, Reporting marathon event. The vertical clearances 5.0, near Port Gamble, WA. The and recordkeeping requirements, for theses bridges in the closed-to- deviation is necessary to accommodate Security measures. navigation position are: Broadway replacement of the draw span operating PART 215—[REMOVED] Bridge provides 69 feet, Morrison Bridge equipment. This deviation allows the provides 69 feet and Hawthorne Bridge bridge to open the draw half-way, 300 ■ Accordingly, by the authority of 5 provides 49 feet; all clearances are feet, after receiving at least a four hour U.S.C. 301, 32 CFR part 215 is removed. referenced to the vertical clearance notice.

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DATES: This deviation is effective from to open half the center span for Navy telephone 206–220–7282, email d13-pf- 12:01 a.m. on May 1, 2018, to 11:59 p.m. and Coast Guard vessels during [email protected]. on September 30, 2018. emergencies, when at least a one hour SUPPLEMENTARY INFORMATION: The ADDRESSES: The docket for this notice has been given by the Department Washington Department of deviation, USCG–2018–0299 is available of the Navy or U.S. Coast Guard. The Transportation, the bridge owner, has at http://www.regulations.gov. Type the Coast Guard will also inform the users docket number in the ‘‘SEARCH’’ box of the waterways through our Local and requested a temporary deviation from and click ‘‘SEARCH.’’ Click on Open Broadcast Notices to Mariners of the the operating schedule for the Montlake Docket Folder on the line associated change in operating schedule for the Bridge across Lake Washington Ship with this deviation. bridge so that vessels can arrange their Canal, at mile 5.2, at Seattle, WA. The FOR FURTHER INFORMATION CONTACT: If transits to minimize any impact caused deviation is necessary to accommodate you have questions on this temporary by this temporary deviation. the safe crossing of event participants. deviation, call or email Mr. Steven In accordance with 33 CFR 117.35(e), The Montlake Bridge is a double leaf Fischer, Bridge Administrator, the drawbridge must return to its regular bascule bridge; in the closed-to- Thirteenth Coast Guard District; operating schedule immediately at the navigation position the bridge provides telephone 206–220–7282, email d13-pf- end of the effective period of this 30 feet of vertical clearance, and [email protected]. temporary deviation. This deviation provides 46 feet of vertical clearance at from the operating regulations is SUPPLEMENTARY INFORMATION: The the center 60 feet of the bridge. To Washington Department of authorized under 33 CFR 117.35. facilitate this event, the double bascule Transportation (WSDOT), the bridge Dated: April 10, 2018. span is authorized to remain in the owner, has requested a temporary Steven Fischer, closed-to-navigation position from 8 deviation from the operating schedule of Chief, Bridge Program, Thirteenth Coast a.m. to 9 a.m. on May 20, 2018. The the Hood Canal Bridge. The request is Guard District. Coast Guard coordinated with the local for the subject bridge to be allowed to [FR Doc. 2018–07956 Filed 4–16–18; 8:45 am] mariners by requesting any objections open half of the draw span to facilitate BILLING CODE 9110–04–P via the Local Notice to Mariners. safe and uninterrupted draw span The normal operating schedule for the equipment replacement. The Hood Montlake Bridge operates in accordance Canal Bridge crosses Hood Canal, mile DEPARTMENT OF HOMELAND with 33 CFR 117.1051(e). Waterway 5.0, near Port Gamble, WA. The bridge SECURITY usage on the Lake Washington Ship has two fixed spans (east and west), and Canal ranges from commercial tug and one draw span (center). The east span Coast Guard provides 50 feet of vertical clearance, barge to small pleasure craft. Vessels the west span provides 35 feet of 33 CFR Part 117 able to pass through the bridge in the closed-to-navigation position may do so vertical clearance, and the center span [Docket No. USCG–2018–0327] provides zero feet of vertical clearance at any time. The bridge will be able to in the closed-to-navigation position. The Drawbridge Operation Regulation; open for emergencies. Lake Washington center span provides unlimited vertical Lake Washington Ship Canal, Seattle, Ship Canal has no immediate alternate clearance in the open-to-navigation WA route for vessels to pass. The Coast position. Vertical clearances are Guard will also inform the users of the referenced to mean high-water AGENCY: Coast Guard, DHS. waterways through our Local and elevation. ACTION: Notice of deviation from Broadcast Notices to Mariners of the This deviation allows the center span drawbridge regulation. change in operating schedule for the of the Hood Canal Bridge to open half- SUMMARY: The Coast Guard has issued a bridge so that vessels can arrange their way (300 feet vice 600 feet) on signal temporary deviation from the operating transits to minimize any impact caused after receiving at least a four hour notice schedule that governs the Montlake by the temporary deviation. from 12:01 a.m. on May 1, 2018, to Bridge across Lake Washington Ship In accordance with 33 CFR 117.35(e), 11:59 p.m. on September 30, 2018. Canal, mile 5.2, at Seattle, WA. The the drawbridge must return to its regular During the period of this deviation, the deviation is necessary to accommodate drawbridge will not be able to operate operating schedule immediately at the the annual Beat the Bridge run to benefit according to the normal operating end of the designated time period. This the Juvenile Diabetes Research schedule. The normal operating deviation from the operating regulations Foundation. This deviation allows the schedule for the Hood Canal Bridge is is authorized under 33 CFR 117.35. bridge span to remain in the closed-to- in accordance with 33 CFR 117.1045. navigation position. Dated: April 10, 2018. The bridge shall operate in accordance Steven M. Fischer, to 33 CFR 117.1045 at all other times. DATES: This deviation is effective from 8 a.m. to 9 a.m. on May 20, 2018. Bridge Administrator, Thirteenth Coast Guard Waterway usage on this part of Hood District. Canal (Admiralty Inlet) includes ADDRESSES: The docket for this [FR Doc. 2018–07957 Filed 4–16–18; 8:45 am] commercial tugs and barges, U.S. Navy deviation, USCG–2018–0327 is available and U.S. Coast Guard vessels, and small at http://www.regulations.gov. Type the BILLING CODE 9110–04–P pleasure craft. Coordination has been docket number in the ‘‘SEARCH’’ box completed with known waterway users, and click ‘‘SEARCH.’’ Click on Open and a no objections to the deviation Docket Folder on the line associated have been received. with this deviation. Vessels able to pass through the east FOR FURTHER INFORMATION CONTACT: If and west spans may do so at any time. you have questions on this temporary The center span does not provide deviation, call or email Mr. Steven passage in the closed-to-navigation Fischer, Bridge Administrator, position. The subject bridge will be able Thirteenth Coast Guard District;

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DEPARTMENT OF HOMELAND River, mile 12.1, in Portland, OR. The deviation, call or email Mr. Steven SECURITY deviation is necessary to support Fischer, Bridge Administrator, multiple events. This deviation allows Thirteenth Coast Guard District; Coast Guard the lower lift span of the bridge to telephone 206–220–7282, email d13-pf- remain in the closed-to-navigation [email protected]. 33 CFR Part 117 position. SUPPLEMENTARY INFORMATION: Union DATES: This deviation is effective from [Docket No. USCG–2018–0284] Pacific Railroad Company (UPRR) owns 9:30 a.m. on May 6, 2018 to 11:59 p.m. and operates the Steel Bridge across the Drawbridge Operation Regulation; on June 23, 2018. Willamette River, at mile 12.1, in Willamette River, Portland, OR ADDRESSES: The docket for this Portland, OR. UPRR requested a deviation, USCG–2018–0284, is AGENCY: Coast Guard, DHS. temporary deviation from the operating available at http://www.regulations.gov. ACTION: Notice of deviation from schedule for the Steel Bridge upper lift drawbridge regulation. Type the docket number in the ‘‘SEARCH’’ box and click ‘‘SEARCH.’’ span. The deviation is necessary to accommodate multiple community SUMMARY: The Coast Guard has issued a Click on Open Docket Folder on the line temporary deviation from the operating associated with this deviation. events. This deviation authorizes UPRR schedule that governs the upper deck of FOR FURTHER INFORMATION CONTACT: If to operate the Steel Bridge upper lift the Steel Bridge across the Willamette you have questions on this temporary span as follows:

Time/date start Time/date end Action

8 a.m./May 6, 2018 ...... 9:30 a.m./May 6, 2018 ...... Upper lift closed. 7 p.m./June 2, 2018 ...... 11:59 p.m./June 2, 2018 ...... Upper lift closed. 7 a.m./June 9, 2018 ...... 1 p.m./June 9, 2018 ...... Upper lift closed. 4 a.m./June 23, 2018 ...... 11:59 p.m./June 23, 2018 ...... Upper lift closed.

The Steel Bridge is a double-deck lift so that vessel operators can arrange their daily twice an hour opening schedule of bridge, and the lower lift span operates transits to minimize any impact caused the Venetian Causeway Bridges (East independent of the upper lift span. To by the temporary deviation. and West) to include weekends and facilitate this deviation, the upper deck In accordance with 33 CFR 117.35(e), Federal holidays. This action is will remain in the closed-to-navigation the drawbridge must return to its regular intended to reduce vehicular traffic position. When the lower deck is in the operating schedule immediately at the caused by the on-demand weekend and closed-to-navigation position, the bridge end of the designated time period. This Federal holiday bridge openings. provides 26 feet of vertical clearance deviation from the operating regulations DATES: This rule is effective May 17, above Columbia River Datum 0.0; and in is authorized under 33 CFR 117.35. 2018. open-to-navigation position, the vertical Dated: April 10, 2018. clearance is 71 feet above Columbia Steven M. Fischer, ADDRESSES: To view documents River Datum 0.0. The lower lift deck of Bridge Administrator, Thirteenth Coast Guard mentioned in this preamble as being the Steel Bridge operates in accordance District. available in the docket, go to http:// with 33 CFR 117.5. The upper lift deck [FR Doc. 2018–07955 Filed 4–16–18; 8:45 am] www.regulations.gov. Type USCG– of the Steel Bridge operates in BILLING CODE 9110–04–P 2017–0068 in the ‘‘SEARCH’’ box and accordance with 33 CFR click ‘‘SEARCH.’’ Click on Open Docket 117.897(c)(3)(ii), and at the end of this Folder on the line associated with this deviation period, the upper deck of the DEPARTMENT OF HOMELAND rulemaking. Steel Bridge will resume operating in SECURITY accordance with 33 CFR FOR FURTHER INFORMATION CONTACT: If 117.897(c)(3)(ii). Coast Guard you have questions on this rule, call or Waterway usage on this part of the email LT Ruth Sadowitz, Coast Guard Willamette River includes vessels 33 CFR Part 117 Sector Miami, FL, Waterways Management Division, telephone 305– ranging from commercial tug and barge [Docket No. USCG–2017–0068] to small pleasure craft. Vessels able to 535–4307, email ruth.a.sadowitz@ pass through the subject bridge with the RIN 1625–AA09 uscg.mil. upper deck in the closed-to-navigation SUPPLEMENTARY INFORMATION: position may do so at any time. The Drawbridge Operation Regulation; lower lift of the Steel Bridge will be able Atlantic Intracoastal Waterway and I. Table of Abbreviations Biscayne Bay, Miami, FL to open for emergencies, and there is no CFR Code of Federal Regulations immediate alternate route for vessels to AGENCY: Coast Guard, DHS. DHS Department of Homeland Security pass. The Coast Guard requested ACTION: Final rule. FR Federal Register objections be submitted to this deviation OMB Office of Management and Budget in the Local Notice to Mariners. We SUMMARY: The Coast Guard is modifying NPRM Notice of proposed rulemaking have not received any objections to this the operating schedule that governs the (Advance, Supplemental) temporary deviation from the operating Venetian Causeway Bridge (West) across § Section U.S.C. United States Code schedule. The Coast Guard will also the Atlantic Intracoastal Waterway mile AICW Atlantic Intracoastal Waterway inform the users of the waterway 1088.6, and the operating schedule that FDOT Florida Department of through our Local and Broadcast governs the Venetian Causeway Bridge Transportation Notices to Mariners of the change in (East) across Biscayne Bay, Miami FL Florida operating schedule for the subject bridge Beach, FL. This action will extend the MHW Mean High Water

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II. Background Information and V. Regulatory Analyses concerning its provisions or options for Regulatory History We developed this rule after compliance, please contact the person On September 5, 2017, we published considering numerous statutes and listed in the FOR FURTHER INFORMATION a notice of proposed rulemaking Executive Orders related to rulemaking. CONTACT, above. (NPRM) entitled Drawbridge Operation Below we summarize our analyses Small businesses may send comments Regulation; Atlantic Intracoastal based on a number of these statutes and on the actions of Federal employees Waterway and Biscayne Bay, Miami, FL Executive Orders, and we discuss First who enforce, or otherwise determine in the Federal Register (82 FR 41901). Amendment rights of protesters. compliance with, Federal regulations to We received 2 comments on this rule. the Small Business and Agriculture A. Regulatory Planning and Review Regulatory Enforcement Ombudsman III. Legal Authority and Need for Rule Executive Orders 12866 and 13563 and the Regional Small Business The Coast Guard is issuing this rule direct agencies to assess the costs and Regulatory Fairness Boards. The under authority in 33 U.S.C. 499. benefits of available regulatory Ombudsman evaluates these actions The Venetian Causeway Bridge alternatives and, if regulation is annually and rates each agency’s (West), across the Atlantic Intracoastal necessary, to select regulatory responsiveness to small business. If you Waterway, mile 1088.6, is a double leaf approaches that maximize net benefits. wish to comment on actions by bascule bridge and has a vertical Executive Order 13771 directs agencies employees of the Coast Guard, call 1– clearance of 12 feet at Mean High Water to control regulatory costs through a 888–REG–FAIR (1–888–734–3247). The (MHW) in the closed to navigation budgeting process. This rule has not Coast Guard will not retaliate against position and a horizontal clearance of been designated a ‘‘significant small entities that question or complain 90 feet between fenders. The Venetian regulatory action,’’ under Executive about this rule or any policy or action Causeway Bridge (East), across Biscayne Order 12866. Accordingly, it has not of the Coast Guard. Bay, at Miami Beach, FL is a double leaf been reviewed by the Office of C. Collection of Information bascule bridge with a vertical clearance Management and Budget (OMB) and of 5 feet at MHW in the closed to pursuant to OMB guidance it is exempt This rule calls for no new collection navigation position and a horizontal from the requirements of Executive of information under the Paperwork clearance of 57 feet between fenders. Order 13771. Reduction Act of 1995 (44 U.S.C. 3501– Presently, in accordance with 33 CFR This regulatory action determination 3520). 117.261(nn) and 33 CFR 117.269, the is based on the continued ability for D. Federalism and Indian Tribal bridges shall open on signal, except that vessels to transit the bridge during the Government from 7 a.m. to 7 p.m., Monday through twice-an-hour opening schedule. Friday, except Federal holidays, the Vessels in distress, Public vessels of the A rule has implications for federalism bridges need only open on the hour and United States and tugs with tows must under Executive Order 13132, half hour. be passed at any time. Federalism, if it has a substantial direct Miami-Dade County, the bridge effect on the States, on the relationship B. Impact on Small Entities owner, and the Cities of Miami and between the national government and Miami Beach requested the daily twice The Regulatory Flexibility Act of 1980 the States, or on the distribution of an hour operating schedule for both (RFA), 5 U.S.C. 601–612, as amended, power and responsibilities among the bridges be changed to include weekends requires federal agencies to consider the various levels of government. We have and Federal holidays. This should potential impact of regulations on small analyzed this rule under that Order and provide relief to the increase vehicle entities during rulemaking. The term have determined that it is consistent traffic congestion on the weekends ‘‘small entities’’ comprises small with the fundamental federalism while meeting the reasonable needs of businesses, not-for-profit organizations principles and preemption requirements navigation. that are independently owned and described in Executive Order 13132. operated and are not dominant in their Also, this rule does not have tribal IV. Discussion of Comments, Changes fields, and governmental jurisdictions implications under Executive Order and the Final Rule with populations of less than 50,000. 13175, Consultation and Coordination Of the 2 comments received, one was The Coast Guard received no comments with Indian Tribal Governments, a political statement that had no bearing from the Small Business Administration because it does not have a substantial on the proposed regulation; the second on this rule. The Coast Guard certifies direct effect on one or more Indian comment was in favor of the operating under 5 U.S.C. 605(b) that this rule will tribes, on the relationship between the schedule change. The submitter in favor not have a significant economic impact Federal Government and Indian tribes, of the change did suggest that there may on a substantial number of small or on the distribution of power and be a negative impact to small entities on entities. responsibilities between the Federal land economically if the bridge is open While some owners or operators of Government and Indian tribes. for an extended period of time allowing vessels intending to transit the bridge E. Unfunded Mandates Reform Act vessels that have been waiting to pass may be small entities, for the reasons and vice versa for commercial vessels stated in section V.A above, this rule The Unfunded Mandates Reform Act that missed the opening and have to will not have a significant economic of 1995 (2 U.S.C. 1531–1538) requires wait until the next scheduled opening. impact on any vessel owner or operator. Federal agencies to assess the effects of While the Coast Guard does Under section 213(a) of the Small their discretionary regulatory actions. In acknowledge that there may be Business Regulatory Enforcement particular, the Act addresses actions additional vessels waiting for openings Fairness Act of 1996 (Pub. L. 104–121), that may result in the expenditure by a due to this change, it should not have we want to assist small entities in State, local, or tribal government, in the a substantial negative impact on land understanding this rule. If the rule aggregate, or by the private sector of and maritime traffic as it mirrors the would affect your small business, $100,000,000 (adjusted for inflation) or current operating schedule Monday organization, or governmental more in any one year. Though this rule through Friday. jurisdiction and you have questions will not result in such an expenditure,

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we do discuss the effects of this rule § 117.269 Biscayne Bay. I. Table of Abbreviations elsewhere in this preamble. The Venetian Causeway Bridge (East), CFR Code of Federal Regulations F. Environment across Miami Beach Channel. The draw DHS Department of Homeland Security shall open on signal, except that from 7 FR Federal Register We have analyzed this rule under a.m. to 7 p.m. daily, including Federal NPRM Notice of proposed rulemaking Department of Homeland Security holidays, the draw need only open on § Section Management Directive 023–01 and the hour and half hour. U.S.C. United States Code Commandant Instruction M16475.lD, Dated: February 8, 2018. II. Background Information and which guides the Coast Guard in Peter J. Brown, Regulatory History complying with the National Rear Admiral, U.S. Coast Guard, Commander, The Coast Guard is issuing this Environmental Policy Act of 1969 Seventh Coast Guard District. temporary rule without prior notice and (NEPA) (42 U.S.C. 4321–4370f), and [FR Doc. 2018–08011 Filed 4–16–18; 8:45 am] opportunity to comment pursuant to have made a determination that this BILLING CODE 9110–04–P authority under section 4(a) of the action is one of a category of actions Administrative Procedure Act (APA) which do not individually or (5 U.S.C. 553(b)). This provision cumulatively have a significant effect on DEPARTMENT OF HOMELAND authorizes an agency to issue a rule the human environment. This rule SECURITY without prior notice and opportunity to simply promulgates the operating comment when the agency for good regulations or procedures for Coast Guard cause finds that those procedures are drawbridges. This action is categorically ‘‘impracticable, unnecessary, or contrary excluded from further review, under 33 CFR Part 165 to the public interest.’’ Under 5 U.S.C. figure 2–1, paragraph (32)(e), of the 553(b)(B), the Coast Guard finds that Instruction. [Docket Number USCG–2018–0205] good cause exists for not publishing a A Record of Environmental RIN 1625–AA00 notice of proposed rulemaking (NPRM) Consideration and a Memorandum for with respect to this rule because of the the Record are not required for this rule. Safety Zone; Barge PFE–LB444, San emergent nature of the situation. G. Protest Activities Joaquin River, Blackslough Landing, Delaying the effective date of this rule CA would be impracticable because The Coast Guard respects the First immediate action is needed protect Amendment rights of protesters. AGENCY: Coast Guard, DHS. personnel, vessels, and the marine Protesters are asked to contact the ACTION: Temporary final rule. environment from potential hazards person listed in the FOR FURTHER associated with the barge and associated INFORMATION CONTACT section to SUMMARY: The Coast Guard is recovery efforts. coordinate protest activities so that your establishing a temporary safety zone for Under 5 U.S.C. 553(d)(3), the Coast message can be received without navigable waters of the San Joaquin Guard finds that good cause exists for jeopardizing the safety or security of River due to an unstable, partially making this rule effective less than 30 people, places or vessels. submerged barge with hull number days after publication in the Federal PFE–LB444. The temporary safety zone Register. A barge with hull number List of Subjects in 33 CFR Part 117 is needed to protect personnel, vessels, PFE–LB444 broke free from its mooring and the marine environment from Bridges. near Blackslough Landing and sank in potential hazards created by the barge the navigable channel. This vessel has For the reasons discussed in the and associated recovery efforts. Entry of since been temporarily secured to shore. preamble, the Coast Guard amends 33 vessels or persons into this zone is The barge remains in an unstable CFR part 117 as follows: prohibited unless specifically condition and continues to shift in authorized by the Captain of the Port orientation and aspect. A safety zone is PART 117—DRAWBRIDGE San Francisco. OPERATION REGULATIONS needed to protect personnel, vessels, DATES: This rule is effective without and the marine environment from actual notice from April 17, 2018 until potential hazards associated with the ■ 1. The authority citation for part 117 April 30, 2018. For the purposes of barge and associated recovery efforts. continues to read as follows: enforcement, actual notice will be used III. Legal Authority and Need for Rule Authority: 33 U.S.C. 499; 33 CFR 1.05–1; from March 30, 2018 until April 17, Department of Homeland Security Delegation 2018. The Coast Guard is issuing this rule No. 0170.1. under authority in 33 U.S.C. 1231; 50 ADDRESSES: To view documents U.S.C. 191; 33 CFR 1.05–1, 6.04–1, ■ 2. Amend § 117.261 by revising mentioned in this preamble as being paragraph (nn) to read as follows: 6.04–6, 160.5; Department of Homeland available in the docket, go to http:// Security Delegation No. 0170.1, which § 117.261 Atlantic Intracoastal Waterway www.regulations.gov, type USCG–2018– collectively authorize the Coast Guard from St. Marys River to Key Largo. 0205 in the ‘‘SEARCH’’ box and click to establish safety zones. The Captain of ‘‘SEARCH.’’ Click on Open Docket * * * * * the Port San Francisco (COTP) has Folder on the line associated with this determined that potential hazards (nn) The Venetian Causeway Bridge rule. (West), mile 1088.6, at Miami. The draw associated with the barge and associated FOR FURTHER INFORMATION CONTACT: If recovery efforts starting March 30, 2018, shall open on signal, except that from 7 you have questions on this rule, call or a.m. to 7 p.m. daily, including Federal will be a safety concern for anyone email Lieutenant Junior Grade Emily K. within a 90-yard radius of the barge. holidays, the draw need only open on Rowan, U.S. Coast Guard Sector San the hour and half hour. This rule is needed to protect personnel, Francisco; telephone 415–399–7443, vessels, and the marine environment in * * * * * email [email protected]. the navigable waters within the safety ■ 3. Revise § 117.269 to read as follows: SUPPLEMENTARY INFORMATION: zone.

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IV. Discussion of the Rule businesses, not-for-profit organizations effect on the States, on the relationship This rule establishes a temporary that are independently owned and between the national government and safety zone from March 30, 2018 operated and are not dominant in their the States, or on the distribution of through April 30, 2018. The safety zone fields, and governmental jurisdictions power and responsibilities among the will cover all navigable waters within with populations of less than 50,000. various levels of government. We have 90 yards of the unstable barge and The Coast Guard certifies under 5 U.S.C. analyzed this rule under that Order and associated recovery efforts centered in 605(b) that this rule will not have a have determined that it is consistent approximate position 37°59′41.88″ N, significant economic impact on a with the fundamental federalism 121°25′8.88″ W (NAD 83). The effect of substantial number of small entities. principles and preemption requirements the temporary safety zone is intended to This rule may affect the following described in Executive Order 13132. protect personnel, vessels, and the entities, some of which may be small Also, this rule does not have tribal marine environment in these navigable entities: Owners and operators of implications under Executive Order waters from potential hazards associated waterfront facilities, commercial 13175, Consultation and Coordination with the barge and associated recovery vessels, and pleasure craft engaged in with Indian Tribal Governments, efforts. No vessel or person will be recreational activities and sightseeing, if because it does not have a substantial permitted to enter the safety zone these facilities or vessels are in the direct effect on one or more Indian without obtaining permission from the vicinity of the safety zone at times when tribes, on the relationship between the COTP or a designated representative. this zone is being enforced. This rule Federal Government and Indian tribes, will not have a significant economic or on the distribution of power and V. Regulatory Analyses impact on a substantial number of small responsibilities between the Federal We developed this rule after entities for the following reasons: (i) Government and Indian tribes. If you considering numerous statutes and This rule will encompass only a small believe this rule has implications for Executive orders related to rulemaking. portion of the waterway for a limited federalism or Indian tribes, please Below we summarize our analyses period of time, and (ii) the maritime contact the person listed in the FOR based on a number of these statutes and public will be advised in advance of FURTHER INFORMATION CONTACT section Executive orders, and we discuss First these safety zones via Broadcast Notice above. Amendment rights of protestors. to Mariners. Under section 213(a) of the Small E. Unfunded Mandates Reform Act A. Regulatory Planning and Review Business Regulatory Enforcement The Unfunded Mandates Reform Act Executive Orders 12866 and 13563 Fairness Act of 1996 (Pub. L. 104–121), of 1995 (2 U.S.C. 1531–1538) requires direct agencies to assess the costs and we want to assist small entities in Federal agencies to assess the effects of benefits of available regulatory understanding this rule. If the rule their discretionary regulatory actions. In alternatives and, if regulation is would affect your small business, particular, the Act addresses actions necessary, to select regulatory organization, or governmental that may result in the expenditure by a approaches that maximize net benefits. jurisdiction and you have questions State, local, or tribal government, in the Executive Order 13771 directs agencies concerning its provisions or options for aggregate, or by the private sector of to control regulatory costs through a compliance, please contact the person $100,000,000 (adjusted for inflation) or budgeting process. This rule has not listed in the FOR FURTHER INFORMATION more in any one year. Though this rule been designated a ‘‘significant CONTACT section. will not result in such an expenditure, regulatory action,’’ under Executive Small businesses may send comments we do discuss the effects of this rule Order 12866. Accordingly, this rule has on the actions of Federal employees elsewhere in this preamble. not been reviewed by the Office of who enforce, or otherwise determine F. Environment Management and Budget (OMB), and compliance with, Federal regulations to pursuant to OMB guidance it is exempt the Small Business and Agriculture We have analyzed this rule under from the requirements of Executive Regulatory Enforcement Ombudsman Department of Homeland Security Order 13771. and the Regional Small Business Management Directive 023–01, which This regulatory action determination Regulatory Fairness Boards. The guides the Coast Guard in complying is based on the limited duration and Ombudsman evaluates these actions with the National Environmental Policy narrowly tailored geographic area of the annually and rates each agency’s Act of 1969 (42 U.S.C. 4321–4370f), and safety zone. Although this rule restricts responsiveness to small business. If you have determined that this action is one access to the waters encompassed by the wish to comment on actions by of a category of actions that do not safety zone, the effect of this rule will employees of the Coast Guard, call 1– individually or cumulatively have a not be significant because the local 888–REG–FAIR (1–888–734–3247). The significant effect on the human waterway users will be notified via Coast Guard will not retaliate against environment. This rule involves safety public Broadcast Notice to Mariners to small entities that question or complain zones of limited size and duration. It is ensure the safety zone will result in about this rule or any policy or action categorically excluded from further minimum impact. The entities most of the Coast Guard. review under Categorical Exclusion likely to be affected are waterfront L60(d) of Appendix A, Table 1 of DHS facilities, commercial vessels, and C. Collection of Information Instruction Manual 023–01–001–01, pleasure craft engaged in recreational This rule will not call for a new Rev. 01. A Record of Environmental activities. collection of information under the Consideration supporting this Paperwork Reduction Act of 1995 (44 determination will be prepared and B. Impact on Small Entities U.S.C. 3501–3520). submitted after issuance or publication The Regulatory Flexibility Act of 1980 in accordance with DHS Instruction D. Federalism and Indian Tribal (RFA), 5 U.S.C. 601–612, as amended, Manual 023–01–001–01, Rev. 01. requires federal agencies to consider the Governments potential impact of regulations on small A rule has implications for federalism G. Protest Activities entities during rulemaking. The term under Executive Order 13132, The Coast Guard respects the First ‘‘small entities’’ comprises small Federalism, if it has a substantial direct Amendment rights of protesters.

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Protesters are asked to contact the (3) Vessel operators desiring to enter call or email Lieutenant Scott Ledee, person listed in the FOR FURTHER or operate within the safety zone must Waterways Management Division Chief, INFORMATION CONTACT section to contact the COTP or a designated Sector Key West, FL, U.S. Coast Guard; coordinate protest activities so that your representative to obtain permission to telephone (305) 292–8768, email message can be received without do so. Vessel operators given permission [email protected]. jeopardizing the safety or security of to enter or operate in the safety zone SUPPLEMENTARY INFORMATION: people, places or vessels. must comply with all directions given to them by the COTP or a designated I. Table of Abbreviations List of Subjects in 33 CFR Part 165 representative. Persons and vessels may COTP Captain of the Port Harbors, Marine safety, Navigation request permission to enter the safety CFR Code of Federal Regulations (water), Reporting and recordkeeping zones on VHF–23A or through the 24- DHS Department of Homeland Security requirements, Security measures, hour Command Center at telephone FR Federal Register Waterways. (415) 399–3547. NPRM Notice of proposed rulemaking § Section For the reasons discussed in the Dated: March 29, 2018 U.S.C. United States Code preamble, the Coast Guard amends 33 Anthony J. Ceraolo, II. Background, Purpose, and Legal CFR part 165 as follows: Captain, U.S. Coast Guard, Captain of the Port, San Francisco. Basis PART 165—REGULATED NAVIGATION Swim events and marine events are AREAS AND LIMITED ACCESS AREAS [FR Doc. 2018–08012 Filed 4–16–18; 8:45 am] BILLING CODE 9110–04–P held on an annual recurring basis on the navigable waters within the Sector Key ■ 1. The authority citation for part 165 West COTP Zone. In the past, the Coast continues to read as follows: DEPARTMENT OF HOMELAND Guard has established safety zones for Authority: 33 U.S.C 1231; 50 U.S.C. 191; SECURITY these annual recurring events on a case 33 CFR 1.05–1, 6.04–1, 6.04–6, and 160.5; by case basis to ensure the protection of Department of Homeland Security Delegation Coast Guard the maritime public and event No. 0170.1 participants from the hazards associated ■ 2. Add § 165.T11–921 to read as 33 CFR Part 165 with these events. This rule will follows: [Docket Number USCG–2017–0159] consistently apprise the public in a timely manner through permanent § 165.T11–921 Safety Zone; Barge PFE– RIN 1625–AA00 publication in Title 33 of the Code of LB444, San Joaquin River, Blackslough Federal Regulations. The Table in this Landing, CA. Safety Zone; Recurring Marine Events, rule lists each annual recurring event Sector Key West, Florida (a) Location. The following area is a requiring a regulated area as safety zone: all navigable waters within AGENCY: Coast Guard, DHS. administered by the Coast Guard. 90 yards of the unstable, partially ACTION: Final rule. By establishing a permanent submerged barge and associated regulation containing these annual recovery efforts centered in approximate SUMMARY: The Coast Guard is ° ′ ″ ° ′ ″ recurring marine events, the Coast position 37 59 41.88 N, 121 25 8.88 W establishing moving safety zones for Guard would eliminate the need to (NAD 83). certain waters within the Sector Key establish temporary rules for events that (b) Enforcement period. The zone West Captain of the Port (COTP) Zone occur on an annual basis. On May 16, described in paragraph (a) of this for five annually recurring marine 2017, the Coast Guard published a section will be enforced from March 30, events. This action is necessary to notice of proposed rulemaking (NPRM) 2018 through April 30, 2018. The provide for the safety of the titled Safety Zone; Recurring Marine Captain of the Port San Francisco participants, participant vessels, and the Events, Sector Key West, Florida, 82 FR (COTP) will notify the maritime general public on the navigable waters 22448. There we stated why we issued community of periods during which of the United States during these events. the NPRM, and invited comments on these zones will be enforced via When these safety zones are activated our proposed regulatory action related Broadcast Notice to Mariners in and subject to enforcement, this rule to these recurring marine events. During accordance with 33 CFR 165.7. would prohibit persons and vessels, the comment period that ended June 15, (c) Definitions. As used in this other than those participating in the 2017, we received no comments. section, ‘‘designated representative’’ event, from entering, transiting through, The legal basis and authorities for this means a Coast Guard Patrol anchoring in, or remaining within the rule is found in 33 U.S.C. 1231. Commander, including a Coast Guard regulated area unless authorized by the III. Discussion of Comments, Changes, coxswain, petty officer, or other officer COTP Key West or a designated and the Rule on a Coast Guard vessel or a Federal, representative. State, or local officer designated by or As noted above, we received no DATES: This rule is effective May 17, assisting the COTP in the enforcement comments on our NPRM published May 2018. of the safety zone. 16, 2017. There are no changes in the (d) Regulations. (1) Under the general ADDRESSES: To view documents regulatory text of this rule from the regulations in 33 CFR part 165, subpart mentioned in this preamble as being proposed rule in the NPRM. This rule C, entry into, transiting or anchoring available in the docket, go to http:// establishes five new annually recurring within this safety zone is prohibited www.regulations.gov, type USCG–2017– marine events to 33 CFR 165.786, as unless authorized by the COTP or the 0159 in the ‘‘SEARCH’’ box and click listed in the attached Table to § 165.786. COTP’s designated representative. ‘‘SEARCH.’’ Click on Open Docket The Table provides the event name, the (2) The safety zone is closed to all Folder on the line associated with this sponsor name, the location of the event, vessel traffic, except as may be rule. and the approximate date and time of permitted by the COTP or a designated FOR FURTHER INFORMATION CONTACT: If each event. The specific times, dates, representative. you have questions on this rulemaking, regulated areas and enforcement period

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for each event will be provided through Notice of Enforcement published in the D. Federalism and Indian Tribal Broadcast Notice to Mariners, a Notice Federal Register. Governments of Enforcement published in the Federal Register, and the Local Notice to B. Impact on Small Entities A rule has implications for federalism under Executive Order 13132, Mariners which can be found at the The Regulatory Flexibility Act of following link: https:// Federalism, if it has a substantial direct 1980, 5 U.S.C. 601–612, as amended, effect on the States, on the relationship www.navcen.uscg.gov/?pageName= requires Federal agencies to consider lnmDistrict®ion=7. between the national government and the potential impact of regulations on the States, or on the distribution of The safety zones established by this small entities during rulemaking. The rule would cover all waters within 50 power and responsibilities among the term ‘‘small entities’’ comprises small various levels of government. We have yards in front of the lead safety vessel businesses, not-for-profit organizations preceding the first event participants, 50 analyzed this rule under that Order and that are independently owned and yards behind the safety vessel trailing have determined that it is consistent operated and are not dominant in their the last event participants, and at all with the fundamental federalism fields, and governmental jurisdictions times extend 100 yards on either side of principles and preemption requirements the safety vessels. with populations of less than 50,000. described in Executive Order 13132. The Coast Guard received no comments This rule prevents vessels from Also, this rule does not have tribal from the Small Business Administration transiting areas specifically designated implications under Executive Order as safety zones during the periods of on this rulemaking. The Coast Guard 13175, Consultation and Coordination enforcement to ensure the protection of certifies under 5 U.S.C. 605(b) that this with Indian Tribal Governments, the maritime public and event rule will not have a significant because it would not have a substantial participants from the hazards associated economic impact on a substantial direct effect on one or more Indian with the listed annual recurring events. number of small entities. tribes, on the relationship between the No vessel or person would be permitted While some owners or operators of Federal Government and Indian tribes, to enter the safety zone without vessels intending to transit the safety or on the distribution of power and obtaining permission from the COTP zones may be small entities, for the responsibilities between the Federal Key West or a designated representative. reasons stated in section IV.A above, Government and Indian tribes. If you The regulatory text appears at the end this rule would not have a significant believe this rule has implications for of this document. economic impact on any vessel owner federalism or Indian tribes, please FOR or operator. contact the person listed in the IV. Regulatory Analyses FURTHER INFORMATION CONTACT section. Under section 213(a) of the Small We developed this rule after Business Regulatory Enforcement E. Unfunded Mandates Reform Act considering numerous statutes and Fairness Act of 1996 (Pub. L. 104–121), executive orders related to rulemaking. The Unfunded Mandates Reform Act Below we summarize our analyses we want to assist small entities in of 1995 (2 U.S.C. 1531–1538) requires based on a number of these statutes and understanding this rule. If the rule Federal agencies to assess the effects of executive orders and we discuss First would affect your small business, their discretionary regulatory actions. In Amendment rights of protestors. organization, or governmental particular, the Act addresses actions jurisdiction and you have questions that may result in the expenditure by a A. Regulatory Planning and Review concerning its provisions or options for State, local, or tribal government, in the Executive Orders 12866 and 13563 compliance, please contact the person aggregate, or by the private sector of direct agencies to assess the costs and listed in the FOR FURTHER INFORMATION $100,000,000 (adjusted for inflation) or benefits of available regulatory CONTACT section. more in any one year. Though this rule alternatives and, if regulation is Small businesses may send comments would not result in such an necessary, to select regulatory on the actions of Federal employees expenditure, we do discuss the effects of approaches that maximize net benefits. who enforce, or otherwise determine this rule elsewhere in this preamble. Executive Order 13771 directs agencies compliance with, Federal regulations to F. Environment to control regulatory costs through a the Small Business and Agriculture budgeting process. This rule has not Regulatory Enforcement Ombudsman We have analyzed this rule under been designated a ‘‘significant and the Regional Small Business Department of Homeland Security regulatory action,’’ under Executive Regulatory Fairness Boards. The Directive 023–01, which guides the Order 12866. Accordingly, this rule has Ombudsman evaluates these actions Coast Guard in complying with the not been reviewed by the Office of annually and rates each agency’s National Environmental Policy Act of Management and Budget (OMB), and responsiveness to small business. If you 1969 (42 U.S.C. 4321–4370f), and have pursuant to OMB guidance it is exempt wish to comment on actions by determined that this action is one of a from the requirements of Executive category of actions that do not employees of the Coast Guard, call 1– Order 13771. individually or cumulatively have a 888–REG–FAIR (1–888–734–3247). The This regulatory action determination significant effect on the human Coast Guard will not retaliate against is based on: (1) The safety zones would environment. This rule involves the only be enforced during limited time small entities that question or complain establishment of safety zones. It is intervals during the swim and paddle about this rule or any policy or action categorically excluded from further events; (2) vessels may be authorized to of the Coast Guard. review under paragraph L60(a) of enter the regulated areas with C. Collection of Information Appendix A, Table 1 of DHS Instruction permission of the COTP Key West or a Manual 023–01–001–01, Rev. 01. A designated representative; and (3) This rule would not call for a new Record of Environmental Consideration advanced notification of closures will be collection of information under the supporting this determination is made via Local Notice to Mariners, Paperwork Reduction Act of 1995 (44 available in the docket where indicated Broadcast to Mariners, and through a U.S.C. 3501–3520). under ADDRESSES.

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G. Protest Activities § 165.786 Safety Zone; recurring marine within the regulated area during the events, Sector Key West, Florida. enforcement period shall contact the The Coast Guard respects the First (a) Regulations. (1) In accordance with COTP Sector Key West or the designated Amendment rights of protesters. 33 CFR 165.23, entering, transiting on-scene representative via VHF Protesters are asked to contact the through, anchoring in, or remaining channel 16 or call the Sector Key West person listed in the FOR FURTHER within the safety zones listed in the Command Center at (305) 292–8727 to INFORMATION CONTACT section to Table to § 165.786 during periods of obtain permission. coordinate protest activities so that your enforcement is prohibited unless (b) Definition. The term ‘‘designated message can be received without authorized by the Captain of the Port representative’’ means Coast Guard jeopardizing the safety or security of (COTP) Sector Key West or a designated Patrol Commanders, including Coast people, places, or vessels. representative. Guard coxswains, petty officers, and List of Subjects in 33 CFR Part 165 (2) These regulations will be enforced other officers operating Coast Guard for the duration of each event. vessels, and Federal, state, and local Harbors, Marine safety, Navigation Notifications of exacts dates and times officers designated by or assisting the (water), Reporting and recordkeeping of the enforcement period will be made COTP Key West in the enforcement of requirements, Security measures, to the local maritime community the regulated areas. Waterways. through the Local Notice to Mariners (c) The COTP Key West or designated For the reasons discussed in the and Broadcast Notice to Mariners and representative may delay or terminate preamble, the Coast Guard amends 33 through a Notice of Enforcement in the any event in this subpart at any time to CFR part 165 as follows: Federal Register well in advance of the ensure safety of life or property. Such events. Mariners should consult the action may be justified as a result of PART 165—REGULATED NAVIGATION Federal Register or their Local Notice to weather, traffic density, spectator AREAS AND LIMITED ACCESS AREAS Mariners to remain apprised of schedule operation, or participant behavior. their Local Notice to Mariners to remain (d) The regulated area for all marine ■ 1. The authority citation for part 165 apprised of schedule or event changes. events listed in Table 1 of § 165.786 is continues to read as follows: (3) During periods of enforcement, that area of navigable waters within 50 Authority: 33 U.S.C. 1231; 50 U.S.C. 191; upon being hailed by a Coast Guard yards in front of the lead safety vessel 33 CFR 1.05–1, 6.04–1, 6.04–6, 160.5; vessel by siren, radio, flashing light or preceding the first event participants, 50 Department of Homeland Security Delegation other means, the operator must proceed yards behind the safety vessel trailing No. 0170.1. as directed. the last event participants, and at all ■ 2. Add a new § 165.786 to read as (4) Vessel operators desiring to enter, times extend 100 yards on either side of follows: transit through, anchor in, or remain safety vessels.

TABLE TO § 165.786 [Datum NAD 1983]

4.0 APRIL

4.1 Key West Paddle Board Classic ...... Event Type: Paddle Event. Sponsor: Lazy Dog Adventure Outfitters. Dates: A one day event held on the last weekend in April. Time (Approximate): 9:00 a.m. to 4:00 p.m., daily. Location(s): Begins at Higgs Beach in Key West, Florida at a point Latitude 24°32.81′ N, longitude 081°47.20′ W, thence west offshore of Fort Zach State Park to latitude 24°32.72′ N, longitude 081°48.77′ W, thence north through Key West Harbor to latitude 24°34.10′ N, longitude 081°48.14′ W, thence east through Fleming Cut to latitude 24°34.42′ N, longitude 081°45.08′ W, south on Cow Key Channel to latitude 24°33.04′ N, longitude 081°44.98′ W, and thence west to point of origin at latitude 24°32.81′ N, longitude 081°47.20′ W.

6.0 JUNE

6.1 FKCC Swim Around Key West ...... Event Type: Swim Event. Sponsor: Florida Keys Community College. Dates: A one day event held on a Saturday in June. Time (Approximate): 7:30 a.m. to 4:00 p.m. Location(s): Begins at Smathers Beach in Key West, Florida at a point Latitude 24°33.01′ N, longitude 081°46.47′ W, thence west offshore of Fort Zach State Park to latitude 24°32.72′ N, longitude 081°48.77′ W, thence north through Key West Harbor to latitude 24°34.10′ N, longitude 081°48.14′ W, thence east through Fleming Cut to latitude 24°34.42′ N, longitude 081°45.08′ W, south on Cow Key Channel to latitude 24°33.04′ N, longitude 081°44.98′ W, and thence west to point of origin at latitude 24°33.01′ N, longitude 081°46.47′ W.

6.2 Annual Swim Around Key West ...... Event Type: Swim Event. Sponsor: Key West Athletic Association. Dates: A one day event held on a Saturday in June. Time (Approximate): 7:30 a.m. to 4:00 p.m.

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TABLE TO § 165.786—Continued [Datum NAD 1983] Location(s): Begins at Smathers Beach in Key West, Florida at a point Latitude 24°33.01′ N, longitude 081°46.47′ W, thence west offshore of Fort Zach State Park to latitude 24°32.72′ N, longitude 081°48.77′ W, thence north through Key West Harbor to latitude 24°34.10′ N, longitude 081°48.14′ W, thence east through Fleming Cut to latitude 24°34.42′ N, longitude 081°45.08′ W, south on Cow Key Channel to latitude 24°33.04′ N, longitude 081°44.98′ W, and thence west to point of origin at latitude 24°33.01′ N, longitude 081°46.47′ W.

7.0 JULY

7.1 Hemingway Paddle Board Race ...... Event Type: Paddle Event. Sponsor: Hemingway Sunset Run LLC. Dates: A one day event held on the 2nd or 3rd Saturday in July. Time (Approximate): 6:00 p.m. to 7:30 p.m. Location(s): Begins at Higgs Beach in Key West, Florida at a point Latitude 24°32.79′ N, longitude 081°47.74′ W, thence east to latitude 24°32.56′ N, longitude 081°47.11′ W, thence east to latitude 24°33.01′ N, longitude 081°46.47′ W, thence west to latitude 24°32.56′ N, longitude 081°47.11′ W, and thence west to point of ori- gin at latitude 24°32.79′ N, longitude 081°47.74′ W.

9.0 SEPTEMBER

9.1 Swim for Alligator Lighthouse ...... Event Type: Swim Event. Sponsor: Friends of the Pool. Dates: A one day event held on the 3rd Saturday in September. Time (Approximate): 7:30 a.m. to 4:30 p.m. Location(s) (Primary): Beginning at a point Latitude 24°54.82′ N, lon- gitude 080°38.03′ W, thence to latitude 24°54.36′ N, longitude 080°37.72′ W, thence to latitude 24°51.07′ N, longitude 080°37.14′ W, thence to latitude 24°54.36′ N, longitude 080°37.72′ W, thence to point of origin at latitude 24°54.82′ N, longitude 080°38.03′ W. Location(s) (Alternate)1: Beginning at a point Latitude 24°54.82′ N, lon- gitude 080°38.03′ W, thence to latitude 24°53.25′ N, longitude 080°37.04′ W, thence to latitude 24°52.05′ N, longitude 080°38.85′ W, thence to latitude 24°54.36′ N, longitude 080°37.72′ W, thence to point of origin at latitude 24°54.82′ N, longitude 080°38.03′ W.

Dated: April 3, 2018. of the Keesler Air Force Base (KAFB) SUPPLEMENTARY INFORMATION: The 81st Jeffrey A. Janszen, located in Biloxi, Mississippi, on behalf Security Forces Anti-Terrorism Office, Captain, U.S. Coast Guard, Captain of the of a request by the United States Air KAFB, located in Biloxi, Mississippi is Port Key West. Force (USAF) 81st Security Forces Anti- responsible for United States Air Force [FR Doc. 2018–08014 Filed 4–16–18; 8:45 am] Terrorism Office. The no anchorage perimeter security at KAFB located in BILLING CODE 9110–04–P restricted area will be established by Biloxi, Mississippi. In accordance with placing 12 buoys to demarcate the Department of Defense and Department approximately 10,000 feet of shoreline of the Air Force guidance, the 81st DEPARTMENT OF DEFENSE east to west and extend approximately Security Forces Anti-Terrorism Office is 150 feet from the shoreline of the base. responsible for the antiterrorism efforts Department of the Army, Corps of The restricted area is essential to and force protection of Department of Engineers address a major anti-terrorism and the Air Force assets under his or her safety concern due to the lack of charge. In response to a request by the 33 CFR Part 334 perimeter fencing or physical denial United States Air Force, and pursuant to system. its authorities in Section 7 of the Rivers [COE–2017–0007] and Harbors Act of 1917 (40 Stat. 266; DATES: Effective Date: May 17, 2018. United States Air Force 81st Security 33 U.S.C. 1) and Chapter XIX of the Forces Anti-Terrorism Office, ADDRESSES: U.S. Army Corps of Army Appropriations Act of 1919 (40 Restricted Area, Keesler Air Force Engineers, Attn: CECW–CO (David Stat. 892; 33 U.S.C. 3), the Corps is Base, Biloxi, Mississippi Olson), 441 G Street NW, Washington, amending the regulations in 33 CFR part DC 20314–1000. 334 by establishing a new restricted AGENCY: U.S. Army Corps of Engineers, area. DoD. FOR FURTHER INFORMATION CONTACT: Mr. The proposed rule was published in ACTION: Final rule. David Olson, Headquarters, Operations the November 16, 2017, edition of the and Regulatory Community of Practice, Federal Register (82 FR 53440) and the SUMMARY: The U.S. Army Corps of Washington, DC at 202–761–4922 or Mr. docket number was COE–2017–0007. In Engineers (Corps) is establishing a no Don Mroczko, U.S. Army Corps of response to the proposal, four comments anchorage restricted area within waters Engineers, Mobile District, at 251–690– were received. One commenter stated along the Back Bay of Biloxi shoreline 3185. support for the project. Three agency

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comments were received stating no or operator. In addition, the restricted § 334.787 81st Security Forces Anti- objections to the proposal regarding area is necessary to address a major anti- Terrorism Office, Keesler Air Force Base, cultural resources and fish and wildlife terrorism and safety concern due to the Biloxi, Mississippi; no anchorage restricted area. habitat. lack of perimeter fencing or physical In response to a request by the United denial system. Small entities can utilize (a) The area. The restricted area shall States Air Force, and pursuant to its navigable waters outside of the encompass all navigable waters of the authorities in Section 7 of the Rivers restricted area. Small entities may also United States, as defined at 33 CFR part and Harbors Act of 1917 (40 Stat. 266; transit the restricted area as long as they 329, contiguous to the area identified as 33 U.S.C. 1) and Chapter XIX of the obtain permission from the USAF 81st Keesler Air Force Base (KAFB) and the Army Appropriations Act of 1919 (40 Security Forces Anti-Terrorism Office, mean high water level within an area Stat. 892; 33 U.S.C. 3), the Corps is bounded by the shore and buoys from amending the regulations in 33 CFR part KAFB, Biloxi, Mississippi, or its authorized representative. The restricted the east to the west of the area starting 334 by establishing a new restricted ° ′ ″ area is necessary for security of KAFB. at: Latitude 30 25 11.73 N, longitude area. 88°54′57.69″ W, thence to latitude The Corps determined that the restricted ° ′ ″ ° ′ ″ Procedural Requirements area would have practically no 30 25 11.85 N, longitude 88 55 3.46 W, thence to latitude 30°25′8.00″ N, a. Regulatory Planning and Review. economic impact on the public, any longitude 88°55′10.10″ W, thence to Executive Orders 12866 and 13563 anticipated navigational hazard or latitude 30°25′4.15″ N, longitude direct agencies to assess the costs and interference with existing waterway ° ′ ″ benefits of available regulatory 88 55 16.74 W, thence to latitude traffic. After considering the economic 30°25′6.96″ N, longitude 88°55′24.12″ alternatives and, if regulation is impacts of this restricted area regulation ° ′ ″ necessary, to select regulatory W, thence to latitude 30 25 1.83 N, on small entities, I certify that this longitude 88°55′30.01″ W, thence to approaches that maximize net benefits. action will not have a significant impact ° ′ ″ Executive Order 13771 directs agencies latitude 30 24 56.15 N, longitude on a substantial number of small 88°55′34.16″ W, thence to latitude to control regulatory costs through a entities. ° ′ ″ ° ′ ″ budgeting process. This rule has not 30 24 51.14 N, longitude 88 55 39.56 c. Review Under the National W, thence to latitude 30°24′47.48″ N, been designated a ‘‘significant ° ′ ″ regulatory action,’’ under Executive Environmental Policy Act. This rule will longitude 88 55 46.64 W, thence to not have a significant impact to the latitude 30°24′51.08″ N, longitude Order 12866. Accordingly, this rule has ° ′ ″ quality of the human environment and, 88 55 53.46 W, thence to latitude not been reviewed by the Office of ° ′ ″ ° ′ ″ Management and Budget (OMB), and therefore, preparation of an 30 24 55.30 N, longitude 88 55 59.91 W, thence to latitude 30°24′56.87″ N, pursuant to OMB guidance because it is environmental impact statement is not ° ′ ″ exempt from the requirements of required. An environmental assessment longitude 88 56 7.40 W. The datum is Executive Order 13771. has been prepared. It may be reviewed NAD–83. The Corps has made a determination at the District office listed at the end of (b) The regulations. (1) All persons, this rule is not a significant regulatory the FOR FURTHER INFORMATION CONTACT swimmers, vessels and other craft, action. This regulatory action section, above. except those vessels under the determination is based on the size, supervision or contract to local military d. Unfunded Mandates Act. This rule duration, and location of the restricted or USAF authority, vessels of the United area. The restricted area occupies a does not impose an enforceable duty States Coast Guard, and local or state small portion of the waterway and a among the private sector and, therefore, law enforcement vessels, are prohibited vessel that needs to transit the restricted is not a Federal private sector mandate from entering the restricted area without area may do so if the operator of the and is not subject to the requirements of permission from the USAF 81st Security vessel obtains permission from the Section 202 or 205 of the Unfunded Forces Anti-Terrorism Office, KAFB or USAF 81st Security Forces Anti- Mandates Reform Act (Pub. L. 104–4, its authorized representative. 109 Stat. 48, 2 U.S.C. 1501 et seq.). We Terrorism Office, KAFB or its (2) The restricted area is in effect have also found under Section 203 of authorized representative. twenty-four hours per day and seven b. Impact on Small Entities. the Act, that small governments will not days a week (24/7). The Regulatory Flexibility Act of be significantly or uniquely affected by 1980, 5 U.S.C. 601–612, as amended, this rule. (3) Should warranted access into the requires Federal agencies to consider restricted navigation area be needed, all the potential impact of regulations on List of Subjects in 33 CFR Part 334 entities are required to contact the USAF 81st Security Forces Anti- small entities during rulemaking. The Danger zones, Navigation (water), term ‘‘small entities’’ comprises small Terrorism Office, KAFB, Biloxi, Restricted areas, Waterways. businesses, not-for-profit organizations Mississippi, or its authorized that are independently owned and For the reasons set out in the representative. operated and are not dominant in their preamble, the Corps amends 33 CFR (c) Enforcement. The regulation in fields, and governmental jurisdictions part 334 as follows: this section shall be enforced by the with populations of less than 50,000. USAF 81st Security Forces Anti- The Corps certifies under 5 U.S.C. PART 334—DANGER ZONE AND Terrorism Office, KAFB and/or such 605(b) that this rule would not have a RESTRICTED AREA REGULATIONS agencies or persons as that office may significant economic impact on a designate. substantial number of small entities. ■ 1. The authority citation for part 334 Dated: April 6, 2018. While some owners or operators of continues to read as follows: vessels that intend to transit the Thomas P. Smith, restricted area may be small entities, for Authority: 40 Stat. 266 (33 U.S.C. 1) and Chief, Operations and Regulatory Division, the reasons stated in paragraph (a) above 40 Stat. 892 (33 U.S.C. 3). Directorate of Civil Works. this rule would not have a significant ■ 2. Add § 334.787 to read as follows: [FR Doc. 2018–07919 Filed 4–16–18; 8:45 am] economic impact on any vessel owner BILLING CODE 3720–58–P

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LEGAL SERVICES CORPORATION councils within the period established councils’ oversight functions have been by the Act and part 1603. In 1976, 46 replaced adequately by other offices and 45 CFR Part 1603 state advisory councils were in processes established since 1974. existence, but later reports reflect that Complainants not only have more State Advisory Councils many of these councils rarely, if ever, audiences—including LSC’s OIG, LSC’s AGENCY: Legal Services Corporation. met. Letter from Suzanne B. Glasow, Office of Compliance and Enforcement Senior Counsel for Operations and (OCE), and state bodies—for their ACTION: Final rule. Regulations, Office of General Counsel, complaints, but they also have more SUMMARY: This final rule removes the to Mike Sims, Office of Rep. Pete Laney vehicles for filing complaints, including Legal Services Corporation (LSC) at 1 (Sept. 19, 1989). By 1983, only six by phone, postal mail, email, online, regulation on state advisory councils. state advisory councils appeared to be and through grantee grievance LSC believes this action is appropriate operational and by 1989, only Colorado procedures. The OIG and OCE go because the state advisory councils are and Indiana had functioning state beyond the state advisory committees’ no longer active and their oversight advisory councils. Id. After a diligent narrow role of collecting alleged functions have been replaced search of its records, LSC concluded violations by also investigating the adequately by other offices and that there currently are no active state allegations and using various tools to processes established since the advisory councils and that LSC has no ensure grantee compliance. regulation was promulgated. Executive records of complaints forwarded from Furthermore, state and local funding, Orders 13563, ‘‘Improving Regulation the state advisory councils. state access to justice commissions, and the role of state and local bars in and Regulatory Review,’’ and 13771, II. History of This Rulemaking ‘‘Reducing Regulation and Controlling appointing grantee board members all Regulatory Costs,’’ direct agencies to In 2014, LSC’s Office of the Inspector ensure that there is continued local review their existing regulations and General (OIG) recommended that LSC involvement in legal aid funded by LSC. either ensure that the state advisory repeal or revise any that are obsolete or LSC’s analysis of these mechanisms is councils have been established and are unnecessarily burdensome. Although covered in greater detail in the operational or rescind part 1603. LSC is LSC is not an agency of the Federal Justification Memorandum for rescinding part 1603 for four reasons: (1) government subject to either Executive Rulemaking to Rescind 45 CFR part LSC complied with the requirements of order, LSC regularly reviews its 1603—State Advisory Councils section 1004(f) of the LSC Act by regulations and has determined that this (Justification Memo), available at requesting state governors to appoint regulation can be eliminated. www.lsc.gov/rulemaking. state advisory councils within the On April 23, 2017, the Committee DATES: This final rule is effective on period established by the Act and part approved Management’s proposed May 17, 2018. 1603; (2) section 1004(f) of the LSC Act 2017–2018 rulemaking agenda, which FOR FURTHER INFORMATION CONTACT: and part 1603 provide LSC with included rescinding 45 CFR part 1603 as Stefanie K. Davis, Assistant General discretion to exercise or not exercise the a priority rulemaking item. On October Counsel, Legal Services Corporation, option to appoint state councils; (3) to 15, 2017, the Committee voted to 3333 K Street NW, Washington, DC LSC’s knowledge, there are no recommend that the Board authorize 20007; (202) 295–1563 (phone), (202) functioning state advisory councils; and LSC to begin rulemaking on part 1603. 337–6519 (fax), or [email protected]. (4) there are now numerous oversight On October 17, 2017, the Board SUPPLEMENTARY INFORMATION: mechanisms that fulfill the function of authorized LSC to begin rulemaking. On the state advisory councils. I. Background January 21, 2018, the Committee voted At its January 2015 meeting, the to recommend that the Board authorize Section 1004(f) of the Legal Services Operations and Regulations Committee publication of a Notice of Proposed Corporation Act of 1974 required that (Committee) of LSC’s Board of Directors Rulemaking (NPRM) proposing to repeal ‘‘within six months after the first (Board) recommended including the part 1603. On January 23, 2018, the meeting of the Board, the Board request repeal of part 1603 on LSC’s regulatory Board authorized publication of the the Governor of each State to appoint a agenda, but made the initiative a low NPRM with a 30-day comment period. nine-member advisory council for each priority. On February 1, 2018, LSC published the state.’’ 42 U.S.C. 2996c(f). If ninety days On January 30, 2017, the President NPRM in the Federal Register, 83 FR elapsed without the Governor’s signed Executive Order 13771, 4826. appointing the advisory council, then ‘‘Reducing Regulation and Controlling On April 8, 2018, the Committee ‘‘the Board [was] authorized to appoint Regulatory Costs.’’ Through this voted to recommend that the Board such a council.’’ Id. LSC implemented Executive order, the President directed adopt this final rule and approve its this statutory requirement in 1975 at 45 the heads of executive departments and publication in the Federal Register. On CFR part 1603. agencies to identify at least two prior April 10, 2018, the Board voted to adopt The state advisory councils’ primary regulations to be repealed for each new and publish this final rule. duty was to notify LSC of any ‘‘apparent regulation issued. By operation of the violation’’ by a recipient. 45 CFR LSC Act, LSC is not an executive III. Discussion of the Comment 1603.5. LSC defined ‘‘apparent department or agency subject to the During the 30-day public comment violation’’ as ‘‘a complaint or other Executive order. 42 U.S.C 2996d(e). period, LSC received one comment from written communication alleging facts Consistent with the intent of the a current law student. The commenter which, if established, constitute a Executive order to reduce unnecessary generally supported LSC’s proposal to violation of the [LSC] Act, or any regulations, however, LSC prioritized remove part 1603, citing reasons similar applicable rules, regulations or the repeal of part 1603. to those presented by LSC in the guidelines promulgated pursuant to the Prior to initiating rulemaking, LSC Justification Memo and NPRM. The Act.’’ Id. § 1603.2(b). conducted an analysis of the oversight commenter suggested that the councils LSC met the requirements of § 1004(f) mechanisms that have developed since could be re-established to ensure of the LSC Act by requesting state the LSC Act was passed in 1974. LSC continued local involvement. LSC’s governors to appoint state advisory determined that the state advisory Justification Memo addressed this

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concern directly by describing the appear in the closed rulemaking section SURFACE TRANSPORTATION BOARD variety of mechanisms—for example, at http://www.lsc.gov/about-lsc/laws- state Access to Justice Commissions and regulations-guidance/rulemaking/ 49 CFR Parts 1001, 1003, 1004, 1005, recipients’ own grievance procedures— closed-rulemaking. 1007, 1011, 1012, 1013, 1016, 1018, that ensure local involvement in the 1019, 1033, 1034, 1035, 1037, 1090, operations of LSC funding recipients. List of Subjects in 45 CFR Part 1603 1100, 1101, 1103, 1104, 1105, 1106, 1108, 1110, 1112, 1113, 1114, 1116, The comment also stated that the Advisory committees; Legal services. ‘‘[t]he decision [whether to repeal] 1117, 1119, 1120, 1132, 1133, 1135, should be based on what affect[s] the PART 1603—[REMOVED] 1141, 1144, 1146, 1147, 1150, 1152, United States taxpayers.’’ LSC agrees. 1155, 1177, 1180, 1182, 1184, 1185, 1200, 1220, 1242, 1243, 1244, 1245, LSC does not think it would be a good ■ For the reasons discussed in the use of LSC resources, which include 1246, 1247, 1248, 1253, 1305, 1310, preamble and under the authority of 42 taxpayer money, to rejuvenate the state 1312, 1313, 1319, 1331, and 1333 U.S.C. 2996g(e), LSC is removing 45 advisory councils when their functions are being performed well by a variety of CFR part 1603. [Docket No. EP 746] other mechanisms, as highlighted in the Dated: April 11, 2018. Updating the Code of Federal Justification Memo and the NPRM. Stefanie Davis, Regulations IV. Discussion of the Final Rule Assistant General Counsel. Correction LSC is removing part 1603. In a final [FR Doc. 2018–07963 Filed 4–16–18; 8:45 am] In rule document 2018–06657 rule published elsewhere in this issue of BILLING CODE 7050–01–P beginning on page 15075 in the issue of the Federal Register, LSC is adding to Monday, April 9, 2018, make the part 1603 a regulation governing following correction: requests for testimony and subpoenas On page 15080, in the first column, for documents in cases to which LSC is amendatory instruction 70 should read not a party. as follows: Materials regarding this rulemaking are available in the open rulemaking ■ ‘‘70. In § 1182.2(a)(11), remove ‘‘21 section of LSC’s website at http:// U.S.C. 853a’’ and add in its place ‘‘21 www.lsc.gov/about-lsc/laws-regulations- U.S.C. 862’’. ’’ guidance/rulemaking. After the effective [FR Doc. C1–2018–06657 Filed 4–16–18; 8:45 am] date of the rule, those materials will BILLING CODE 1301–00–D

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Proposed Rules Federal Register Vol. 83, No. 74

Tuesday, April 17, 2018

This section of the FEDERAL REGISTER 5 p.m., Monday through Friday, except substantive verbal contact we receive contains notices to the public of the proposed Federal holidays. about this proposed AD. issuance of rules and regulations. The For service information identified in Discussion purpose of these notices is to give interested this NPRM, contact Airbus SAS, persons an opportunity to participate in the Airworthiness Office—EAW, 1 Rond We issued AD 2017–15–17, rule making prior to the adoption of the final Amendment 39–18977 (82 FR 35644, rules. Point Maurice Bellonte, 31707 Blagnac Cedex, France; telephone +33 5 61 93 36 August 1, 2017) (‘‘AD 2017–15–17’’), for 96; fax +33 5 61 93 44 51; email certain Airbus Model A300 B4–600R DEPARTMENT OF TRANSPORTATION [email protected]; series airplanes, Model A300 C4–605R internet http://www.airbus.com. You Variant F airplanes, and Model A300 Federal Aviation Administration may view this referenced service F4–600R series airplanes. AD 2017–15– information at the FAA, Transport 17 was prompted by the detection of 14 CFR Part 39 Standards Branch, 2200 South 216th St., cracking that originated from the Des Moines, WA. For information on the fastener holes in the forward fitting [Docket No. FAA–2018–0277; Product Identifier 2017–NM–124–AD] availability of this material at the FAA, lower radius of frame (FR) 40. AD 2017– call 206–231–3195. 15–17 requires an inspection of the RIN 2120–AA64 lower area of a certain frame radius for Examining the AD Docket cracking, and corrective action if Airworthiness Directives; Airbus You may examine the AD docket on necessary. We issued AD 2017–15–17 to Airplanes the internet at http:// detect and correct cracking in the AGENCY: Federal Aviation www.regulations.gov by searching for forward fitting lower radius of FR 40. Administration (FAA), DOT. and locating Docket No. FAA–2018– Such cracking could reduce the ACTION: Notice of proposed rulemaking 0277; or in person at the Docket structural integrity of the fuselage. (NPRM). Management Facility between 9 a.m. Since we issued AD 2017–15–17, we and 5 p.m., Monday through Friday, have determined that new repetitive SUMMARY: We propose to supersede except Federal holidays. The AD docket inspections of the lower area of a certain Airworthiness Directive (AD) 2017–15– contains this proposed AD, the frame radius for cracking, and corrective 17, which applies to certain Airbus regulatory evaluation, any comments actions are necessary. Model A300 B4–600R series airplanes, received, and other information. The The European Aviation Safety Agency Model A300 C4–605R Variant F street address for the Docket Operations (EASA), which is the Technical Agent airplanes, and Model A300 F4–600R office (telephone 800–647–5527) is in for the Member States of the European series airplanes. AD 2017–15–17 the ADDRESSES section. Comments will Union, has issued EASA AD 2017–0158, requires an inspection of the lower area be available in the AD docket shortly dated August 25, 2017 (referred to after of a certain frame radius for cracking, after receipt. this as the Mandatory Continuing and corrective action if necessary. Since FOR FURTHER INFORMATION CONTACT: Dan Airworthiness Information, or ‘‘the we issued AD 2017–15–17, we have Rodina, Aerospace Engineer, MCAI’’), to correct an unsafe condition determined that repetitive inspections International Section, Transport for certain Airbus Model A300 B4–600R and applicable corrective actions are Standards Branch, FAA, 2200 South series airplanes, Model A300 C4–605R necessary. This proposed AD would add 216th St., Des Moines, WA 98198; Variant F airplanes, and Model A300 new repetitive inspections of the lower telephone and fax 206–231–3225. F4–600R series airplanes. The MCAI area of a certain frame radius for SUPPLEMENTARY INFORMATION: states: cracking, and corrective actions if Comments Invited Following a full stress analysis of the necessary. We are proposing this AD to Frame (FR) 40 lower area, supported by a address the unsafe condition on these We invite you to send any written Finite Element Model (FEM), of the post-mod products. relevant data, views, or arguments about [modification] 10221 configuration, it was DATES: We must receive comments on this proposed AD. Send your comments demonstrated that, for the FR40 forward to an address listed under the fitting lower radius, a crack could occur after this proposed AD by June 1, 2018. a certain number of flight cycles (FC). ADDRESSES section. Include ‘‘Docket No. ADDRESSES: You may send comments, This condition, if not detected and using the procedures found in 14 CFR FAA–2018–0277; Product Identifier corrected, could reduce the structural 11.43 and 11.45, by any of the following 2017–NM–124–AD’’ at the beginning of integrity of the fuselage. methods: your comments. We specifically invite To address this potential unsafe condition, • Federal eRulemaking Portal: Go to comments on the overall regulatory, Airbus established that crack detection could http://www.regulations.gov. Follow the economic, environmental, and energy be achieved through a special detailed instructions for submitting comments. aspects of this proposed AD. We will inspection (SDI) using a high frequency eddy • Fax: 202–493–2251. consider all comments received by the current (HFEC) method, and issued Alert • Mail: U.S. Department of closing date and may amend this Operators Transmission (AOT) A57W009–16 Transportation, Docket Operations, M– proposed AD based on those comments. to provide those inspection instructions. Consequently, EASA issued AD 2016–0085 30, West Building Ground Floor, Room We will post all comments we to require a one-time SDI of the FR40 lower W12–140, 1200 New Jersey Avenue SE, receive, without change, to http:// area and, depending on findings, Washington, DC 20590. www.regulations.gov, including any accomplishment of applicable corrective • Hand Delivery: Deliver to Mail personal information you provide. We action(s). After that [EASA] AD was issued, address above between 9 a.m. and will also post a report summarizing each further cracks were detected, originating from

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the fastener hole, and, based on these Costs of Compliance the Administrator finds necessary for findings, it was determined that the We estimate that this proposed AD safety in air commerce. This regulation inspection area must be enlarged, and Airbus is within the scope of that authority issued AOT A57W009–16 Revision (Rev.) 01 affects 94 airplanes of U.S. registry. The actions required by AD 2017–15– because it addresses an unsafe condition accordingly. Consequently, EASA issued AD that is likely to exist or develop on 2016–0179 [which corresponds to FAA AD 17, and retained in this proposed AD, take about 4 work-hours per product, at products identified in this rulemaking 2017–15–17], retaining the requirements of action. EASA AD 2016–0085, which was an average labor rate of $85 per work- This AD is issued in accordance with superseded, to extend the area of inspection, hour. Based on these figures, the and to require an additional inspection for estimated cost of the actions that are authority delegated by the Executive aeroplanes that were previously inspected. required by AD 2017–15–17 is $340 per Director, Aircraft Certification Service, The one-time SDI for high cycle A300–600 product. as authorized by FAA Order 8000.51C. aeroplanes was intended to mitigate the We also estimate that it would take In accordance with that order, issuance highest risks within the fleet, pending about 4 work-hours per product to of ADs is normally a function of the development of instructions for repetitive comply with the basic requirements of Compliance and Airworthiness inspections. this proposed AD. The average labor Division, but during this transition Since EASA AD 2016–0179 was issued, rate is $85 per work-hour. Based on period, the Executive Director has Airbus published SB A300–57–6120 * * * these figures, we estimate the cost of delegated the authority to issue ADs [for] the inspection programme for A300–600 applicable to transport category * * * post-mod 10221 * * * [airplanes]. this proposed AD on U.S. operators to be $31,960, or $340 per product. airplanes to the Director of the System The AOT one-time inspection is superseded Oversight Division. by these repetitive inspection SBs. These SBs We have received no definitive data include alternative inspection methods and that would enable us to provide cost Regulatory Findings estimates for the on-condition actions repair solutions in case of findings together We determined that this proposed AD specified in this proposed AD. with the associated inspection programme. would not have federalism implications For the reasons described above, this Paperwork Reduction Act under Executive Order 13132. This [EASA] AD retains the requirements of EASA proposed AD would not have a AD 2016–0179, which is superseded, * * * A federal agency may not conduct or and defines new inspections methods with sponsor, and a person is not required to substantial direct effect on the States, on new compliance times, including repetitive respond to, nor shall a person be subject the relationship between the national inspections, depending on the aeroplane to penalty for failure to comply with a Government and the States, or on the inspection status. collection of information subject to the distribution of power and responsibilities among the various You may examine the MCAI in the AD requirements of the Paperwork Reduction Act unless that collection of levels of government. docket on the internet at http:// For the reasons discussed above, I information displays a current valid www.regulations.gov by searching for certify this proposed regulation: OMB control number. The control and locating Docket No. FAA–2018– 1. Is not a ‘‘significant regulatory number for the collection of information 0277. action’’ under Executive Order 12866; required by this AD is 2120–0056. The 2. Is not a ‘‘significant rule’’ under the Related Service Information Under paperwork cost associated with this AD DOT Regulatory Policies and Procedures 1 CFR Part 51 has been detailed in the Costs of (44 FR 11034, February 26, 1979); Compliance section of this document 3. Will not affect intrastate aviation in Airbus has issued Service Bulletin and includes time for reviewing Alaska; and A300–57–6120, including Appendices 1 instructions, as well as completing and 4. Will not have a significant through 7, dated April 28, 2017. This reviewing the collection of information. economic impact, positive or negative, service information describes Therefore, all reporting associated with on a substantial number of small entities procedures for repetitive inspections of this AD is mandatory. Comments under the criteria of the Regulatory the forward fitting lower radius of FR 40 concerning the accuracy of this burden Flexibility Act. for cracking, and corrective action. This and suggestions for reducing the burden service information is reasonably should be directed to the FAA at 800 List of Subjects in 14 CFR Part 39 available because the interested parties Independence Ave. SW, Washington, have access to it through their normal Air transportation, Aircraft, Aviation DC 20591, ATTN: Information safety, Incorporation by reference, course of business or by the means Collection Clearance Officer, AES–200. identified in the ADDRESSES section. Safety. Authority for This Rulemaking FAA’s Determination and Requirements The Proposed Amendment of This Proposed AD Title 49 of the United States Code Accordingly, under the authority specifies the FAA’s authority to issue delegated to me by the Administrator, This product has been approved by rules on aviation safety. Subtitle I, the FAA proposes to amend 14 CFR part the aviation authority of another section 106, describes the authority of 39 as follows: country, and is approved for operation the FAA Administrator. ‘‘Subtitle VII: in the United States. Pursuant to our Aviation Programs,’’ describes in more PART 39—AIRWORTHINESS bilateral agreement with the State of detail the scope of the Agency’s DIRECTIVES Design Authority, we have been notified authority. of the unsafe condition described in the We are issuing this rulemaking under ■ 1. The authority citation for part 39 MCAI and service information the authority described in ‘‘Subtitle VII, continues to read as follows: referenced above. We are proposing this Part A, Subpart III, Section 44701: Authority: 49 U.S.C. 106(g), 40113, 44701. AD because we evaluated all pertinent General requirements.’’ Under that information and determined an unsafe section, Congress charges the FAA with § 39.13 [Amended] condition exists and is likely to exist or promoting safe flight of civil aircraft in ■ 2. The FAA amends § 39.13 by develop on other products of the same air commerce by prescribing regulations removing Airworthiness Directive (AD) type design. for practices, methods, and procedures 2017–15–17, Amendment 39–18977 (82

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FR 35644, August 1, 2017), and adding holes in the forward fitting lower radius of July 13, 2016, as of the effective date of this the following new AD: frame (FR) 40. We are issuing this AD to AD. detect and correct cracking in the forward (3) For the purpose of this AD, inspection Airbus: Docket No. FAA–2018–0277; Product fitting lower radius of FR 40. Such cracking Identifier 2017–NM–124–AD. method A is a high frequency (HFEC) could reduce the structural integrity of the inspection of the radius and fastener area. (a) Comments Due Date fuselage. Inspection method B is a HFEC inspection of We must receive comments by June 1, (f) Compliance the radius and fastener area and a rototest of 2018. the fastener hole. Both are defined as a Comply with this AD within the special detailed inspection (SDI) in this AD. (b) Affected ADs compliance times specified, unless already This AD replaces AD 2017–15–17, done. (h) Repetitive Inspections for Non-Repaired Amendment 39–18977 (82 FR 35644, August Areas (g) Definitions 1, 2017) (‘‘AD 2017–15–17’’). Within the compliance time specified in (1) For the purpose of this AD, the average table 1 to paragraph (h) of this AD (Group 1 (c) Applicability flight time (AFT) can be established by airplanes) or table 2 to paragraph (h) of this This AD applies to Airbus airplanes, dividing the flight hours (FHs) by the flight AD (Group 2 airplanes), as applicable, and, certificated in any category, identified in cycles (FCs) counted: thereafter, at intervals not exceeding the paragraphs (c)(1), (c)(2), and (c)(3) of this AD, (i) From first flight, for selecting the values specified in table 3 to paragraph (h) on which Airbus Modification 10221 was inspection threshold of the non-repaired embodied in production. area, of this AD, do a SDI for cracking of any non- (1) Airbus Model A300 B4–605R and B4– (ii) From repair, for selecting the repaired radius, fastener areas, and fastener 622R airplanes. inspection threshold of the repaired area, holes, in accordance with the (2) Airbus Model A300 C4–605R Variant F (iii) From the last inspection, for selecting Accomplishment Instructions of Airbus airplanes. the inspection interval. Service Bulletin A300–57–6120, including (3) Airbus Model A300 F4–605R and F4– (2) For the purpose of this AD, Group 1 Appendices 1 through 7, dated April 28, 622R airplanes. airplanes are those airplanes already 2017; except where Airbus Service Bulletin (d) Subject inspected in accordance with paragraph 4.2.2 A300–57–6120, including Appendices 1 through 7, dated April 28, 2017, specifies Air Transport Association (ATA) of in Alert Operators Transmission (AOT) contacting Airbus for appropriate action, America Code 57, Wings. A57W009–16, Revision 01, dated July 13, 2016, before the effective date of this AD. before further flight, obtain instructions using (e) Reason Group 2 airplanes are those airplanes not the procedures specified in paragraph (l) of This AD was prompted by the detection of inspected in accordance with paragraph 4.2.2 this AD and accomplish those instructions. cracking that originated from the fastener in AOT A57W009–16, Revision 01, dated BILLING CODE 4910–13–P

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Table 2 to Paragraph (h) of this AD- Group 2 Inspection Thresholds- Non-repaired Areas

AFT Compliance Time (whichever occurs later, A orB)

A: Before exceeding 14,700 FC or 31,900 FH since first flight of the airplane, whichever occurs first.

B: Within 12 months after the effective Greater than 1. 5 date of this AD, without exceeding (whichever occurs later):

- 19,000 FC or 41,000 FH, whichever occurs first since airplane first flight.

- 300 FC or 630 FH, whichever occurs first after September 5, 2017 (the effective date of AD 2017-15-17).

A: Before exceeding 15,900 FC or 23,900 FH since first flight of the airplane, whichever occurs first. 1.5 or less B: Within 12 months after the effective date of this AD, without exceeding (whichever occurs later):

- 19,000 FC or 41,000 FH, whichever occurs first since airplane first flight.

- 300 FC or 630 FH, whichever occurs first after September 5, 2017 (the effective date of AD 2017-15-17).

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BILLING CODE 4910–13–C cracking of the repaired radius, fastener A300–57–6120, including Appendices 1 (i) Repetitive Inspections for Repaired Areas areas, and fastener holes, in accordance with through 7, dated April 28, 2017, specifies the Accomplishment Instructions of Airbus contacting Airbus for appropriate action, Within the compliance time values as specified in table 4 to paragraph (i) of this Service Bulletin A300–57–6120, including before further flight, obtain instructions using AD, and, thereafter, at intervals not Appendices 1 through 7, dated April 28, the procedures specified in paragraph (l) of exceeding those same values, do a SDI for 2017; except where Airbus Service Bulletin this AD and accomplish those instructions.

(j) Corrective Action (l) Other FAA AD Provisions EASA Design Organization Approval (DOA). If any crack is found during any inspection (1) Alternative Methods of Compliance If approved by the DOA, the approval must include the DOA-authorized signature. required by paragraph (h) or (i) of this AD: (AMOCs): The Manager, International (3) Required for Compliance (RC): Except Before further flight, repair in accordance Section, Transport Standards Branch, FAA, as required by paragraphs (g) and (h) of this with the Accomplishment Instructions of has the authority to approve AMOCs for this AD, if requested using the procedures found AD: If any service information contains Airbus Service Bulletin A300–57–6120, in 14 CFR 39.19. In accordance with 14 CFR procedures or tests that are identified as RC, including Appendices 1 through 7, dated 39.19, send your request to your principal those procedures and tests must be done to April 28, 2017. inspector or local Flight Standards District comply with this AD; any procedures or tests (k) Reporting Office, as appropriate. If sending information that are not identified as RC are directly to the International Section, send it recommended. Those procedures and tests Submit a report of the findings (both to the attention of the person identified in that are not identified as RC may be deviated positive and negative) of each inspection paragraph (m)(2) of this AD. Information may from using accepted methods in accordance required by paragraph (h) and (i) of this AD be emailed to: 9-ANM-116-AMOC- with the operator’s maintenance or to Airbus, in accordance with the [email protected]. Before using any inspection program without obtaining instructions of Airbus Service Bulletin A300– approved AMOC, notify your appropriate approval of an AMOC, provided the 57–6120, including Appendices 1 through 7, principal inspector, or lacking a principal procedures and tests identified as RC can be dated April 28, 2017, at the applicable time inspector, the manager of the local flight done and the airplane can be put back in an specified in paragraph (k)(1) or (k)(2) of this standards district office/certificate holding airworthy condition. Any substitutions or AD. district office. changes to procedures or tests identified as (2) Contacting the Manufacturer: As of the RC require approval of an AMOC. (1) If the inspection was done on or after effective date of this AD, for any requirement the effective date of this AD: Submit the in this AD to obtain corrective actions from (m) Related Information report within 30 days after the inspection. a manufacturer, the action must be (1) Refer to Mandatory Continuing (2) If the inspection was done before the accomplished using a method approved by Airworthiness Information (MCAI) EASA effective date of this AD: Submit the report the Manager, International Section, Transport Airworthiness Directive 2017–0158, dated within 30 days after the effective date of this Standards Branch, FAA; or the European August 25, 2017, for related information. AD. Aviation Safety Agency (EASA); or Airbus’s This MCAI may be found in the AD docket

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on the internet at http://www.regulations.gov the modified horizontal stabilizer 2018–0271; Product Identifier 2017– by searching for and locating Docket No. leading edge. We are proposing this AD NM–111–AD’’ at the beginning of your FAA–2018–0277. to address the unsafe condition on these comments. We specifically invite (2) For more information about this AD, products. comments on the overall regulatory, contact Dan Rodina, Aerospace Engineer, economic, environmental, and energy International Section, Transport Standards DATES: We must receive comments on Branch, FAA, 2200 South 216th St., Des this proposed AD by June 1, 2018. aspects of this proposed AD. We will Moines, WA 98198; telephone and fax 206– ADDRESSES: You may send comments, consider all comments received by the 231–3225. using the procedures found in 14 CFR closing date and may amend this (3) For service information identified in 11.43 and 11.45, by any of the following proposed AD based on those comments. We will post all comments we this AD, contact Airbus SAS, Airworthiness methods: Office—EAW, 1 Rond Point Maurice receive, without change, to http:// • Federal eRulemaking Portal: Go to Bellonte, 31707 Blagnac Cedex, France; www.regulations.gov, including any http://www.regulations.gov. Follow the telephone +33 5 61 93 36 96; fax +33 5 61 personal information you provide. We 93 44 51; email account.airworth-eas@ instructions for submitting comments. • Fax: 202–493–2251. will also post a report summarizing each airbus.com; internet http://www.airbus.com. substantive verbal contact we receive You may view this service information at the • Mail: U.S. Department of about this proposed AD. FAA, Transport Standards Branch, 2200 Transportation, Docket Operations, M– South 216th St., Des Moines, WA. For 30, West Building Ground Floor, Room Discussion information on the availability of this W12–140, 1200 New Jersey Avenue SE, We issued AD 2016–13–06, material at the FAA, call 206–231–3195. Washington, DC 20590. • Amendment 39–18570 (81 FR 41432, Issued in Des Moines, Washington, on Hand Delivery: Deliver to Mail June 27, 2016) (‘‘AD 2016–13–06’’), for March 30, 2018. address above between 9 a.m. and 5 certain Saab AB, Saab Aeronautics Chris Spangenberg, p.m., Monday through Friday, except Model 340A (SAAB/SF340A) and SAAB Acting Director, System Oversight Division, Federal holidays. 340B airplanes. AD 2016–13–06 was Aircraft Certification Service. For service information identified in prompted by reports of ruptured [FR Doc. 2018–07626 Filed 4–16–18; 8:45 am] this NPRM, contact Saab AB, Saab horizontal stabilizer de-icing boots. AD BILLING CODE 4910–13–P Aeronautics, SE–581 88, Linko¨ping, 2016–13–06 requires a revision of the Sweden; telephone: +46 13 18 5591; fax: applicable AFM, repetitive inspections +46 13 18 4874; email: of the horizontal stabilizer de-icing DEPARTMENT OF TRANSPORTATION [email protected]; boots, and applicable corrective actions. internet: http://www.saabgroup.com. We issued AD 2016–13–06 to detect and Federal Aviation Administration You may view this referenced service correct damage of the de-icing boot; information at the FAA, Transport such damage could lead to a ruptured 14 CFR Part 39 Standards Branch, 2200 South 216th St., boot, severe vibrations, and possible [Docket No. FAA–2018–0271; Product Des Moines, WA. For information on the reduced control of the airplane. Identifier 2017–NM–111–AD] availability of this material at the FAA, Since we issued AD 2016–13–06, the call 206–231–3195. manufacturer has developed an RIN 2120–AA64 Examining the AD Docket improved de-icing boot, reinforced through double stitch lines. Airworthiness Directives; Saab AB, You may examine the AD docket on Saab Aeronautics (Formerly Known as The European Aviation Safety Agency the internet at http:// (EASA), which is the Technical Agent Saab AB, Saab Aerosystems) www.regulations.gov by searching for Airplanes for the Member States of the European and locating Docket No. FAA–2018– Union, has issued EASA AD 2017–0144, AGENCY: Federal Aviation 0271; or in person at the Docket dated August 9, 2017 (referred to after Administration (FAA), DOT. Management Facility between 9 a.m. this as the Mandatory Continuing and 5 p.m., Monday through Friday, ACTION: Notice of proposed rulemaking Airworthiness Information, or ‘‘the except Federal holidays. The AD docket (NPRM). MCAI’’), to correct an unsafe condition contains this proposed AD, the for certain Saab AB, Saab Aeronautics SUMMARY: We propose to supersede regulatory evaluation, any comments Model 340A (SAAB/SF340A) and SAAB Airworthiness Directive (AD) 2016–13– received, and other information. The 340B airplanes. The MCAI states: 06, which applies to certain Saab AB, street address for the Docket Operations office (telephone: 800–647–5527) is in Several occurrences were reported of Saab Aeronautics Model 340A (SAAB/ rupture of the horizontal stabilizer de-icing SF340A) and SAAB 340B airplanes. AD the ADDRESSES section. Comments will boot in flight. In some of the reported events, 2016–13–06 requires a revision of the be available in the AD docket shortly the de-icing boot had formed a large open applicable airplane flight manual after receipt. scoop. (AFM), repetitive inspections of the FOR FURTHER INFORMATION CONTACT: This condition, if not detected and horizontal stabilizer de-icing boots, and Shahram Daneshmandi, Aerospace corrected, could lead to complete loss of the applicable corrective actions. Since we Engineer, International Section, de-icing function within its associated zone and severe vibrations, possibly resulting in issued AD 2016–13–06, the Transport Standards Branch, FAA, 2200 reduced control of the aeroplane. manufacturer has developed an South 216th St., Des Moines, WA 98198; To address this potential unsafe condition, improved de-icing boot. This proposed telephone and fax: 206–231–3220. Saab AB, Aeronautics (hereafter referred to as AD would continue to require a revision SUPPLEMENTARY INFORMATION: ‘‘Saab’’ in this [EASA] AD) issued Alert of the applicable AFM, repetitive Operations Bulletin (AOB) No. 12 and AOB inspections of the horizontal stabilizer Comments Invited No. 23 as temporary measures, de-icing boots, and applicable corrective We invite you to send any written recommending to select Flaps 0 for landing in the event of a suspected rupture of the de- actions. This proposed AD would also relevant data, views, or arguments about icing boot on the horizontal stabilizer. In require replacement of single stitched this proposal. Send your comments to addition, Saab issued SB [Service Bulletin] de-icing boots with improved double an address listed under the ADDRESSES 340–30–094 providing instructions for stitched boots, and re-identification of section. Include ‘‘Docket No. FAA– inspection of de-icing boots.

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Consequently, EASA issued AD 2015–0129 Design Authority, we have been notified of ADs is normally a function of the [which corresponds to FAA AD 2016–13–06] of the unsafe condition described in the Compliance and Airworthiness to require amendment of the applicable MCAI and service information Division, but during this transition Aircraft Flight Manual (AFM), repetitive referenced above. We are proposing this period, the Executive Director has inspections of the horizontal stabilizer de- icing boots and, depending on findings, AD because we evaluated all pertinent delegated the authority to issue ADs accomplishment of applicable corrective information and determined an unsafe applicable to transport category action(s). condition exists and is likely to exist or airplanes to the Director of the System Since that [EASA] AD was issued, Saab develop on other products of these same Oversight Division. developed an improved de-icing boot, type designs. reinforced through double stitch lines, and Regulatory Findings Costs of Compliance issued SB 340–30–095 providing instructions We determined that this proposed AD for boot replacement. We estimate that this proposed AD would not have federalism implications For the reason described above, this affects 51 airplanes of U.S. registry. under Executive Order 13132. This [EASA] AD retains the requirements of EASA The actions required by AD 2016–13– AD 2015–0129, which is superseded, and proposed AD would not have a 06, and retained in this proposed AD substantial direct effect on the States, on requires replacement of single stitched de- take about 6 work-hours per product, at icing boots, installed on the left-hand (LH) the relationship between the national and right-hand (RH) horizontal stabilizer, an average labor rate of $85 per work- Government and the States, or on the with improved double stitched boots, and re- hour. Based on these figures, the distribution of power and identification of the modified horizontal estimated cost of the actions that are responsibilities among the various stabilizer leading edge. required by AD 2016–13–06 is $510 per levels of government. You may examine the MCAI in the product. In addition, we estimate that any For the reasons discussed above, I AD docket on the internet at http:// necessary follow-on actions required by certify this proposed regulation: www.regulations.gov by searching for AD 2016–13–06, and retained in this 1. Is not a ‘‘significant regulatory and locating Docket No. FAA–2018– proposed AD take about 6 work-hours action’’ under Executive Order 12866; 0271. and require parts costing $9,500, for a 2. Is not a ‘‘significant rule’’ under the Related Service Information Under cost of $10,010 per product. We have no DOT Regulatory Policies and Procedures 1 CFR Part 51 way of determining the number of (44 FR 11034, February 26, 1979); Saab AB, Saab Aeronautics has issued aircraft that might need these actions. 3. Will not affect intrastate aviation in We also estimate that it would take the following service information. Alaska; and • about 6 work-hours per product to Service Bulletin 340–30–094, dated 4. Will not have a significant March 27, 2015. This service comply with the basic requirements of this proposed AD. The average labor economic impact, positive or negative, information describes procedures for on a substantial number of small entities repetitive detailed inspections of the de- rate is $85 per work-hour. Required parts would cost about $13,500 per under the criteria of the Regulatory icing boots installed on the horizontal Flexibility Act. stabilizers, and repair and replacement product. Based on these figures, we of damaged de-icing boots. estimate the cost of this proposed AD on List of Subjects in 14 CFR Part 39 • Service Bulletin 340–30–095, dated U.S. operators to be $714,510, or April 3, 2017. This service information $14,010 per product. Air transportation, Aircraft, Aviation safety, Incorporation by reference, describes procedures for replacement of Authority for This Rulemaking single stitched de-icing boots with Safety. Title 49 of the United States Code improved double stitched boots, and re- The Proposed Amendment identification of the modified horizontal specifies the FAA’s authority to issue stabilizer leading edge. rules on aviation safety. Subtitle I, Accordingly, under the authority Saab AB, Saab Aeronautics has also section 106, describes the authority of delegated to me by the Administrator, issued the following AFMs, which the FAA Administrator. ‘‘Subtitle VII: the FAA proposes to amend 14 CFR part describe performance limitations and Aviation Programs,’’ describes in more 39 as follows: general data. These AFMs are distinct detail the scope of the Agency’s since they apply to different airplane authority. PART 39—AIRWORTHINESS models in different configurations. We are issuing this rulemaking under DIRECTIVES • AFM 340A 001, Revision 57, dated the authority described in ‘‘Subtitle VII, March 27, 2015. Part A, Subpart III, Section 44701: ■ 1. The authority citation for part 39 • AFM 340B 001, Revision 35, dated General requirements.’’ Under that continues to read as follows: March 27, 2015. section, Congress charges the FAA with Authority: 49 U.S.C. 106(g), 40113, 44701. • AFM 340B 010, Revision 28, dated promoting safe flight of civil aircraft in March 27, 2015. air commerce by prescribing regulations § 39.13 [Amended] This service information is reasonably for practices, methods, and procedures ■ 2. The FAA amends § 39.13 by available because the interested parties the Administrator finds necessary for removing Airworthiness Directive (AD) have access to it through their normal safety in air commerce. This regulation 2016–13–06, Amendment 39–18570 (81 course of business or by the means is within the scope of that authority FR 41432, June 27, 2016), and adding identified in the ADDRESSES section. because it addresses an unsafe condition the following new AD: that is likely to exist or develop on FAA’s Determination and Requirements products identified in this rulemaking Saab AB, Saab Aeronautics (Formerly of This Proposed AD action. Known as Saab AB, Saab Aerosystems): This product has been approved by This AD is issued in accordance with Docket No. FAA–2018–0271; Product Identifier 2017–NM–111–AD. the aviation authority of another authority delegated by the Executive country, and is approved for operation Director, Aircraft Certification Service, (a) Comments Due Date in the United States. Pursuant to our as authorized by FAA Order 8000.51C. We must receive comments by June 1, bilateral agreement with the State of In accordance with that order, issuance 2018.

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(b) Affected ADs icing boots, in accordance with the information. This MCAI may be found in the This AD replaces AD 2016–13–06, Accomplishment Instructions of Saab Service AD docket on the internet at http:// Amendment 39–18570 (81 FR 41432, June Bulletin 340–30–094, dated March 27, 2015. www.regulations.gov by searching for and 27, 2016) (‘‘AD 2016–13–06’’). Repeat the inspection thereafter at intervals locating Docket No. FAA–2018–0271. not to exceed 400 flight hours. If, during any (2) For more information about this AD, (c) Applicability inspection required by this paragraph, any contact Shahram Daneshmandi, Aerospace This AD applies to Saab AB, Saab damage or existing repair outside the limits Engineer, International Section, Transport Aeronautics (formerly known as Saab AB, specified in Saab Service Bulletin 340–30– Standards Branch, FAA, 2200 South 216th Saab Aerosystems) airplanes, certificated in 094, dated March 27, 2015, is found, before St., Des Moines, WA 98198; telephone and any category, identified in paragraphs (c)(1) further flight, repair or replace the horizontal fax: 206–231–3220. and (c)(2), of this AD. stabilizer de-icing boots, in accordance with (3) For service information identified in (1) Saab AB, Saab Aeronautics Model 340A the Accomplishment Instructions of Saab this AD, contact Saab AB, Saab Aeronautics, (SAAB/SF340A) airplanes, serial numbers Service Bulletin 340–30–094, dated March SE–581 88, Linko¨ping, Sweden; telephone: 004 through 138 inclusive, if Saab 27, 2015. Repair or replacement on an +46 13 18 5591; fax: +46 13 18 4874; email: modification 1462 has been embodied in airplane of the horizontal stabilizer de-icing [email protected]; production, or Saab Service Bulletin 340–55– boots, as required by this paragraph, does not internet: http://www.saabgroup.com. You 008 has been embodied in service, except constitute terminating action for the may view this service information at the those that have also embodied Saab repetitive inspections required by this FAA, Transport Standards Branch, 2200 modification 1793 in production, or Saab paragraph for that airplane. South 216th St., Des Moines, WA. For Service Bulletin 340–55–010 in service; and (i) New Requirement of This AD: information on the availability of this serial numbers 139 through 159 inclusive. Modification material at the FAA, call 206–231–3195. (2) Saab AB, Saab Aeronautics Model Issued in Des Moines, Washington, on SAAB 340B airplanes, serial numbers 160 Within 18 months after the effective date March 30, 2018. through 459 inclusive. of this AD, modify the airplane by replacing the single stitched de-icing boots installed on Chris Spangenberg, (d) Subject the left-hand (LH) and right-hand (RH) Acting Director, System Oversight Division, Air Transport Association (ATA) of horizontal stabilizers with double stitched Aircraft Certification Service. America Code 30, Ice and rain protection. de-icing boots and re-identify the LH and RH horizontal stabilizer leading edge, in [FR Doc. 2018–07636 Filed 4–16–18; 8:45 am] (e) Reason accordance with the Accomplishment BILLING CODE 4910–13–P This AD was prompted by reports of Instructions of Saab Service Bulletin 340–30– ruptured horizontal stabilizer de-icing boots. 095, dated April 3, 2017. We are issuing this AD to detect and correct DEPARTMENT OF TRANSPORTATION (j) Terminating Action ruptured horizontal stabilizer de-icing boots, which could lead to complete loss of the de- Modification of the airplane as required by Federal Aviation Administration icing function within its associated zone and paragraph (i) of this AD, constitutes severe vibrations, possibly resulting in terminating action for the repetitive 14 CFR Part 39 reduced control of the airplane. inspections required by paragraph (h) of this AD, for that airplane. [Docket No. FAA–2018–0142; Product (f) Compliance Identifier 2018–NE–04–AD] (k) Other FAA AD Provisions Comply with this AD within the RIN 2120–AA64 compliance times specified, unless already (1) Alternative Methods of Compliance done. (AMOCs): The Manager, International Section, Transport Standards Branch, FAA, Airworthiness Directives; General (g) Retained Revision of the Airplane Flight has the authority to approve AMOCs for this Electric Company CF34–8E Engines Manual (AFM), With No Changes AD, if requested using the procedures found AGENCY: This paragraph restates the requirements of in 14 CFR 39.19. In accordance with 14 CFR Federal Aviation paragraph (g) of AD 2016–13–06, with no 39.19, send your request to your principal Administration (FAA), DOT. changes. Within 30 days after August 1, 2016 inspector or local Flight Standards District ACTION: Notice of proposed rulemaking (the effective date of AD 2016–13–06), revise Office, as appropriate. If sending information (NPRM). the ‘‘Abnormal Procedures’’ section of the directly to the International Section, send it applicable Saab 340 AFM to incorporate the to the attention of the person identified in SUMMARY: We propose to adopt a new revision specified in paragraphs (g)(1) paragraph (l)(2) of this AD. Information may airworthiness directive (AD) for all through (g)(3) of this AD. be emailed to: 9-ANM-116-AMOC- General Electric Company (GE) CF34–8E (1) For Saab AB, Saab Aeronautics Model [email protected]. Before using any turbofan engines. This proposed AD was 340A (SAAB/SF340A) airplanes, revise AFM approved AMOC, notify your appropriate prompted by a report from GE regarding 340A 001 by incorporating Revision 57, principal inspector, or lacking a principal dated March 27, 2015. inspector, the manager of the local flight a quality escape of nonconforming (2) For Saab AB, Saab Aeronautics Model standards district office/certificate holding thrust reverser fire seals. This proposed SAAB 340B airplanes, revise AFM 340B 001 district office. AD would require a one-time inspection by incorporating Revision 35, dated March (2) Contacting the Manufacturer: As of the of the gap between the core cowl seal 27, 2015. effective date of this AD, for any requirement and the pylon seal of the thrust reverser (3) For Saab AB, Saab Aeronautics Model in this AD to obtain corrective actions from for correct gap width, and replacement SAAB 340B airplanes with extended wing a manufacturer, the action must be of the seals, if needed. We are proposing tips, revise AFM 340B 010 by incorporating accomplished using a method approved by this AD to address the unsafe condition Revision 28, dated March 27, 2015. the Manager, International Section, Transport Standards Branch, FAA; or the European on these products. (h) Retained Inspection/Replacement, With Aviation Safety Agency (EASA); or Saab AB, DATES: We must receive comments on No Changes Saab Aeronautics EASA Design Organization this proposed AD by June 1, 2018. This paragraph restates the requirements of Approval (DOA). If approved by the DOA, ADDRESSES: You may send comments, paragraph (h) of AD 2016–13–06, with no the approval must include the DOA- using the procedures found in 14 CFR changes. Within 400 flight hours or 6 authorized signature. months, whichever occurs first after August 11.43 and 11.45, by any of the following 1, 2016 (the effective date of AD 2016–13– (l) Related Information methods: 06), do a detailed inspection for damage of (1) Refer to Mandatory Continuing • Federal eRulemaking Portal: Go to the horizontal stabilizer de-icing boots, and Airworthiness Information (MCAI) EASA AD http://www.regulations.gov. Follow the existing repairs of horizontal stabilizer de- 2017–0144, dated August 9, 2017, for related instructions for submitting comments.

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• Fax: 202–493–2251. 238–7129; fax: 781–238–7199; email: requirement could result in fire outside • Mail: U.S. Department of [email protected]. the fire zone. This unsafe condition, if Transportation, Docket Operations, M– SUPPLEMENTARY INFORMATION: not addressed, could result in an 30, West Building Ground Floor, Room uncontrolled fire, damage to the engine, W12–140, 1200 New Jersey Avenue SE, Comments Invited and damage to the airplane. Washington, DC 20590. We invite you to send any written Related Service Information • Hand Delivery: Deliver to Mail relevant data, views, or arguments about address above between 9 a.m. and 5 this proposal. Send your comments to We reviewed GE CF34–8E Service p.m., Monday through Friday, except an address listed under the ADDRESSES Bulletin (SB) 78–0066 R00, dated Federal holidays. section. Include ‘‘Docket No. FAA– December 11, 2017. The SB describes For service information identified in 2018–0142; Product Identifier 2018– procedures for measuring the width of this NPRM, contact General Electric NE–04–AD’’ at the beginning of your the RTV filled gap between the thrust Company, 1 Neumann Way, Cincinnati, comments. We specifically invite reverser fire seals at the 12 o’clock core OH 45215; telephone 513–552–3272; comments on the overall regulatory, cowl seal and pylon seal installed on email [email protected]. economic, environmental, and energy thrust reverser P/Ns 15G0002–013, You may view this service information aspects of this NPRM. We will consider 15G0002–014, 15G0003–013, and at the FAA, Engine and Propeller all comments received by the closing 15G0003–014, and replacing with parts Standards Branch, 1200 District date and may amend this NPRM eligible for installation, if needed. Avenue, Burlington, MA 01803. For because of those comments. FAA’s Determination information on the availability of this We will post all comments we material at the FAA, call 781–238–7759. receive, without change, to http:// We are proposing this AD because we Examining the AD Docket www.regulations.gov, including any evaluated all the relevant information personal information you provide. We and determined the unsafe condition You may examine the AD docket on will also post a report summarizing each described previously is likely to exist or the internet at http:// substantive verbal contact we receive develop in other products of the same www.regulations.gov by searching for about this NPRM. type design. and locating Docket No. FAA–2018– 0142; or in person at Docket Operations Discussion Proposed AD Requirements between 9 a.m. and 5 p.m., Monday We received a report from the This proposed AD would require a through Friday, except Federal holidays. manufacturer about a fire seal gap one-time inspection of the gap between The AD docket contains this NPRM, the quality escape on GE CF34–8E turbofan the core cowl seal and the pylon seal of regulatory evaluation, any comments engines. Some thrust reverser fire seals, the thrust reverser for correct gap width, received, and other information. The installed on thrust reverser part and replacement of the thrust reverser street address for Docket Operations numbers (P/Ns) 15G0002–013, fire seals, if needed. (phone: 800–647–5527) is listed above. 15G0002–014, 15G0003–013, and Costs of Compliance Comments will be available in the AD 15G0003–014, were shipped from a docket shortly after receipt. supplier with nonconforming seal gaps. We estimate that this proposed AD FOR FURTHER INFORMATION CONTACT: An analysis by the manufacturer has affects 936 engines installed on David Bethka, Aerospace Engineer, ECO shown that a gap between the 12 o’clock airplanes of U.S. registry. Branch, FAA, 1200 District Avenue, core cowl seal and pylon seal that is We estimate the following costs to Burlington, MA 01803; phone: 781– greater than the 1 mm design comply with this proposed AD:

ESTIMATED COSTS

Cost per Cost on U.S. Action Labor cost Parts cost product operators

Inspection ...... 0.25 work-hours × $85 per hour = $21.25 ...... $0 $21.25 $19,890

We estimate the following costs to do be required based on the results of the determining the number of aircraft that any necessary replacements that would proposed inspection. We have no way of might need these replacements:

ON-CONDITION COSTS

Cost per Action Labor cost Parts cost product

Remove and replace thrust reverser fire seals ...... 2.75 work-hours × $85 per hour = $233.75 ...... $3,228 $3,461.75

Authority for This Rulemaking detail the scope of the Agency’s air commerce by prescribing regulations authority. for practices, methods, and procedures Title 49 of the United States Code We are issuing this rulemaking under the Administrator finds necessary for specifies the FAA’s authority to issue safety in air commerce. This regulation rules on aviation safety. Subtitle I, the authority described in Subtitle VII, Part A, Subpart III, Section 44701: is within the scope of that authority section 106, describes the authority of ‘‘General requirements.’’ Under that because it addresses an unsafe condition the FAA Administrator. Subtitle VII: section, Congress charges the FAA with that is likely to exist or develop on Aviation Programs, describes in more promoting safe flight of civil aircraft in

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products identified in this rulemaking (a) Comments Due Date (i) Related Information action. We must receive comments by June 1, (1) For more information about this AD, This AD is issued in accordance with 2018. contact David Bethka, Aerospace Engineer, authority delegated by the Executive ECO Branch, FAA,1200 District Avenue, (b) Affected ADs Director, Aircraft Certification Service, Burlington, MA 01803; phone: 781–238– as authorized by FAA Order 8000.51C. None. 7129; fax: 781–238–7199; email: [email protected]. In accordance with that order, issuance (c) Applicability of ADs is normally a function of the (2) For service information identified in This AD applies to all General Electric this AD, contact General Electric Company, Compliance and Airworthiness Company (GE) CF34–8E turbofan engines. 1 Neumann Way, Cincinnati, OH 45215; Division, but during this transition (d) Subject telephone 513–552–3272; email period, the Executive Director has [email protected]. You may view delegated the authority to issue ADs Joint Aircraft System Component (JASC) this referenced service information at the applicable to engines, propellers, and Code 7830, Thrust Reverser. FAA, Engine and Propeller Standards associated appliances to the Manager, (e) Unsafe Condition Branch, 1200 District Avenue, Burlington, MA 01803. For information on the Engine and Propeller Standards Branch, This AD was prompted by a report from GE Policy and Innovation Division. availability of this material at the FAA, call regarding a quality escape of nonconforming 781–238–7759. Regulatory Findings thrust reverser fire seal gaps. We are issuing this AD to inspect for nonconforming thrust Issued in Burlington, Massachusetts, on We determined that this proposed AD reverser fire seal gaps that could result in a April 9, 2018. would not have federalism implications fire outside the fire zone. The unsafe Robert J. Ganley, under Executive Order 13132. This condition, if not addressed, could result in an Manager, Engine and Propeller Standards proposed AD would not have a uncontrolled fire, damage to the engine, and Branch, Aircraft Certification Service. substantial direct effect on the States, on damage to the airplane. [FR Doc. 2018–07819 Filed 4–16–18; 8:45 am] the relationship between the national (f) Compliance BILLING CODE 4910–13–P government and the States, or on the Comply with this AD within the distribution of power and compliance times specified, unless already responsibilities among the various done. DEPARTMENT OF TRANSPORTATION levels of government. For the reasons discussed above, I (g) Required Actions Federal Aviation Administration certify this proposed regulation: (1) For all CF34–8E turbofan engines, (1) Is not a ‘‘significant regulatory before the engine accumulates 8,000 flight 14 CFR Part 39 action’’ under Executive Order 12866, hours after the effective date of this AD, perform the following one-time inspection, [Docket No. FAA–2018–0276; Product (2) Is not a ‘‘significant rule’’ under Identifier 2017–NM–079–AD] the DOT Regulatory Policies and and, if needed, replace the core cowl seal and pylon seal. Procedures (44 FR 11034, February 26, (i) Measure the width of the RTV filled gap RIN 2120–AA64 1979), between thrust reverser fire seals at the (3) Will not affect intrastate aviation junction between 12 o’clock core cowl seal Airworthiness Directives; The Boeing in Alaska, and and pylon seal, at the following half thrust Company Airplanes (4) Will not have a significant reverser locations: engine 1 left hand (LH) AGENCY: Federal Aviation economic impact, positive or negative, half thrust reverser, part number (P/N) Administration (FAA), DOT. on a substantial number of small entities 15G0002–013; engine 2 LH half thrust under the criteria of the Regulatory reverser, P/N 15G0002–014; engine 1 right ACTION: Notice of proposed rulemaking Flexibility Act. hand (RH) half thrust reverser, P/N 15G0003– (NPRM). 013; and engine 2 RH half thrust reverser List of Subjects in 14 CFR Part 39 P/N 15G0003–014. SUMMARY: We propose to adopt a new (ii) If the gap width between the 12 o’clock Air transportation, Aircraft, Aviation airworthiness directive (AD) for certain core cowl seal and the pylon seal is greater The Boeing Company Model 747–100, safety, Incorporation by reference, than 1 mm, replace both seals with parts Safety. –100B, –100B SUD, –200B, –200C, eligible for installation to form a new gap of –200F, –300, –400, –400D, 747SP, and The Proposed Amendment 1 mm or less, prior to return to service. (2) You may refer to GE CF34–8E Service 747SR, and 747–8 series airplanes. This Accordingly, under the authority Bulletin 78–0066 R00, dated December 11, proposed AD was prompted by reports delegated to me by the Administrator, 2017 for guidance on inspecting and indicating that additional areas of the FAA proposes to amend 14 CFR part replacing the thrust reverser fire seals. Boeing Material Specification (BMS) 8– 39 flexible urethane foam were found 39 as follows: (h) Alternative Methods of Compliance (AMOCs) during an inspection required by a PART 39—AIRWORTHINESS related AD. This proposed AD would DIRECTIVES (1) The Manager, ECO Branch, FAA, has require inspecting for BMS 8–39 flexible the authority to approve AMOCs for this AD, urethane foam insulation in the floor ■ 1. The authority citation for part 39 if requested using the procedures found in 14 CFR 39.19. In accordance with 14 CFR 39.19, panel assemblies and the power drive continues to read as follows: send your request to your principal inspector unit (PDU) cover assemblies; doing Authority: 49 U.S.C. 106(g), 40113, 44701. or local Flight Standards District Office, as applicable on-condition actions; appropriate. If sending information directly modifying certain dripshields; and § 39.13 [Amended] to the manager of the certification office, replacing BMS 8–39 foam strips on ■ 2. The FAA amends § 39.13 by adding send it to the attention of the person certain dripshields with BMS 8–371 the following new airworthiness identified in paragraph (i)(1) of this AD. foam strips. We are proposing this AD (2) Before using any approved AMOC, to address the unsafe condition on these directive (AD): notify your appropriate principal inspector, General Electric Company: Docket No. FAA– or lacking a principal inspector, the manager products. 2018–0142; Product Identifier 2018–NE– of the local Flight Standards District Office/ DATES: We must receive comments on 04–AD. Certificate Holding District Office. this proposed AD by June 1, 2018.

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ADDRESSES: You may send comments, comments. We specifically invite • Boeing Special Attention Service using the procedures found in 14 CFR comments on the overall regulatory, Bulletin 747–25–3646, Revision 1, dated 11.43 and 11.45, by any of the following economic, environmental, and energy August 2, 2017, which describes methods: aspects of this NPRM. We will consider procedures for replacing BMS 8–39 • Federal eRulemaking Portal: Go to all comments received by the closing foam strips with BMS 8–371 foam strips http://www.regulations.gov. Follow the date and may amend this NPRM on certain dripshields. instructions for submitting comments. because of those comments. • Boeing Special Attention Service • Fax: 202–493–2251. We will post all comments we Bulletin 747–25–3692, dated June 22, • Mail: U.S. Department of receive, without change, to http:// 2016, which describes procedures for Transportation, Docket Operations, M– www.regulations.gov, including any modifying and replacing BMS 8–39 30, West Building Ground Floor, Room personal information you provide. We foam strips with BMS 8–371 foam strips W12–140, 1200 New Jersey Avenue SE, will also post a report summarizing each on certain dripshields. Washington, DC 20590. substantive verbal contact we receive This service information is reasonably • Hand Delivery: Deliver to Mail about this proposed AD. available because the interested parties address above between 9 a.m. and 5 Discussion have access to it through their normal p.m., Monday through Friday, except We have received reports indicating course of business or by the means Federal holidays. identified in the ADDRESSES section. For service information identified in that additional areas of BMS 8–39 this NPRM, contact Boeing Commercial flexible urethane foam were found FAA’s Determination Airplanes, Attention: Contractual & Data during the accomplishment of AD 2013– 11–04, Amendment 39–17464 (78 FR We are proposing this AD because we Services (C&DS), 2600 Westminster evaluated all the relevant information Blvd., MC 110–SK57, Seal Beach, CA 33193, June 4, 2013) (‘‘AD 2013–11– 04’’). AD 2013–11–04 was prompted by and determined the unsafe condition 90740–5600; telephone 562–797–1717; described previously is likely to exist or internet https://www.myboeingfleet. in-service reports of burned BMS 8–39 flexible urethane foam, and a report develop in other products of the same com. You may view this referenced type design. service information at the FAA, from the airplane manufacturer Transport Standards Branch, 2200 indicating that airplanes were Proposed AD Requirements South 216th St., Des Moines, WA. For assembled, throughout various areas of the airplane (including flight deck and This proposed AD would require information on the availability of this accomplishment of the actions material at the FAA, call 206–231–3195. cargo compartments), with seals made of BMS 8–39 flexible urethane foam, a identified as ‘‘RC’’ (required for It is also available on the internet at compliance) in the Accomplishment http://www.regulations.gov by searching material with fire-retardant properties that deteriorate with age. AD 2013–11– Instructions of the service information for and locating Docket No. FAA–2018– described previously, except as 0276. 04 requires replacing certain seals made of BMS 8–39 flexible urethane foam. discussed under ‘‘Differences Between Examining the AD Docket BMS 8–39 flexible urethane foam fire this Proposed AD and the Service Information,’’ and except for any You may examine the AD docket on retardants are mixed into, but are not chemically connected with, the differences identified as exceptions in the internet at http:// the regulatory text of this proposed AD. www.regulations.gov by searching for remaining components of the foam. Over time, this condition will cause the For information on the procedures and locating Docket No. FAA–2018– and compliance times, see this service 0276; or in person at the Docket fire-retardant properties to have decreased effectiveness. The concern is information at http:// Management Facility between 9 a.m. www.regulations.gov by searching for and 5 p.m., Monday through Friday, hidden areas where fire cannot easily be detected and suppressed. Aged BMS 8– and locating Docket No. FAA–2018– except Federal holidays. The AD docket 0276. contains this NPRM, the regulatory 39 flexible urethane foam exposed to an evaluation, any comments received, and ignition source provides an Differences Between This Proposed AD other information. The street address for unacceptable fuel source for fire and the Service Information the Docket Office (phone: 800–647– propagation. The degradation of the foam increases the potential for an Although Boeing Special Attention 5527) is in the ADDRESSES section. uncontrolled fire below the passenger Service Bulletin 747–25–3646, Revision Comments will be available in the AD 1, dated August 2, 2017, and Boeing docket shortly after receipt. compartment floor and other locations outside the areas covered by smoke Special Attention Service Bulletin 747– FOR FURTHER INFORMATION CONTACT: detection and fire protection systems. 25–3692, dated June 22, 2016, specify a Scott Craig, Aerospace Engineer, Cabin This condition, if not corrected, could compliance time of 60 months, this AD Safety and Environmental Systems cause an uncontrolled fire leading to specifies a compliance time of 72 Section, FAA, Seattle ACO Branch, 2200 loss of control of the airplane. months for the actions specified in this South 216th St., Des Moines, WA 98198; service information. The 72-month phone and fax: 206–231–3566; email: Related Service Information Under compliance time is in-line with other [email protected]. 1 CFR Part 51 ADs addressing the same unsafe SUPPLEMENTARY INFORMATION: We reviewed the following Boeing condition due to the use of BMS 8–39 service information. flexible urethane foam. We have Comments Invited • Boeing Special Attention Service reviewed the safety impact of the 72- We invite you to send any written Bulletin 747–53–2877, dated August 5, month compliance time and found it relevant data, views, or arguments about 2014, which describes procedures for acceptable. This compliance time has this proposal. Send your comments to performing a general visual inspection been coordinated with Boeing. an address listed under the ADDRESSES for BMS 8–39 flexible urethane foam Costs of Compliance section. Include ‘‘Docket No. FAA– insulation in the floor panel assemblies 2018–0276; Product Identifier 2017– and the PDU cover assemblies, and We estimate that this proposed AD NM–079–AD’’ at the beginning of your applicable on-condition actions. affects 87 airplanes of U.S. registry. We

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estimate the following costs to comply with this proposed AD:

ESTIMATED COSTS

Action Labor cost Parts cost Cost per product Cost on U.S. operators

Inspection and replacement ...... 25 work-hours × $85 per hour = Up to $184,460 Up to $186,585 .... Up to $6,157,305 (33 airplanes $2,125. affected). Modification and installation of the 10 work-hours × $85 per hour = Unavailable 1 .... $850 ...... $44,200 (52 airplanes affected). dripshields. $850. Replacement of the foam on the 8 work-hours × $85 per hour = Unavailable 1 .... $680 ...... $4,760 (7 airplanes affected). dripshields. $680. 1 We have received no definitive data that would enable us to provide parts cost estimates as the parts and materials are to be supplied by the operator for the actions specified in this AD.

We have received no definitive data Regulatory Findings (a) Comments Due Date that would enable us to provide cost We determined that this proposed AD We must receive comments by June 1, estimates for the on-condition actions would not have federalism implications 2018. specified in this proposed AD. under Executive Order 13132. This (b) Affected ADs According to the manufacturer, some proposed AD would not have a None. of the costs of this proposed AD may be substantial direct effect on the States, on (c) Applicability covered under warranty, thereby the relationship between the national reducing the cost impact on affected Government and the States, or on the This AD applies to The Boeing Company distribution of power and airplanes, certificated in any category, as individuals. We do not control warranty identified in paragraphs (c)(1), (c)(2), and coverage for affected individuals. As a responsibilities among the various (c)(3) of this AD. result, we have included all available levels of government. (1) Model 747–100, –100B, –100B SUD, costs in our cost estimate. For the reasons discussed above, I –200B, –200C, –200F, –300, –400, –400D, certify this proposed regulation: 747SP, and 747SR series airplanes, as Authority for This Rulemaking (1) Is not a ‘‘significant regulatory identified in Boeing Special Attention action’’ under Executive Order 12866, Service Bulletin 747–53–2877, dated August Title 49 of the United States Code (2) Is not a ‘‘significant rule’’ under 5, 2014. specifies the FAA’s authority to issue the DOT Regulatory Policies and (2) Model 747–400, –400D, and 747–8 rules on aviation safety. Subtitle I, series airplanes, as identified in Boeing Procedures (44 FR 11034, February 26, Special Attention Service Bulletin 747–25– section 106, describes the authority of 1979), the FAA Administrator. Subtitle VII: 3646, Revision 1, dated August 2, 2017. (3) Will not affect intrastate aviation (3) Model 747–100, –100B, –100B SUD, Aviation Programs, describes in more in Alaska, and –200B, –300, 747SP, and 747SR series detail the scope of the Agency’s (4) Will not have a significant airplanes, as identified in Boeing Special authority. economic impact, positive or negative, Attention Service Bulletin 747–25–3692, We are issuing this rulemaking under on a substantial number of small entities dated June 22, 2016. the authority described in Subtitle VII, under the criteria of the Regulatory (d) Subject Part A, Subpart III, Section 44701: Flexibility Act. Air Transport Association (ATA) of ‘‘General requirements.’’ Under that List of Subjects in 14 CFR Part 39 America Code 25, Equipment/furnishings; section, Congress charges the FAA with 53, Fuselage. Air transportation, Aircraft, Aviation promoting safe flight of civil aircraft in (e) Unsafe Condition air commerce by prescribing regulations safety, Incorporation by reference, Safety. This AD was prompted by reports for practices, methods, and procedures indicating that additional areas of Boeing the Administrator finds necessary for The Proposed Amendment Material Specification (BMS) 8–39 flexible safety in air commerce. This regulation urethane foam were found during an is within the scope of that authority Accordingly, under the authority inspection required by a related AD. The because it addresses an unsafe condition delegated to me by the Administrator, degradation of the foam increases the that is likely to exist or develop on the FAA proposes to amend 14 CFR part potential for an uncontrolled fire below the products identified in this rulemaking 39 as follows: passenger compartment floor and other locations outside the areas covered by smoke action. PART 39—AIRWORTHINESS detection and fire protection systems. We are This proposed AD is issued in DIRECTIVES issuing this AD to detect and replace BMS 8– accordance with authority delegated by 39 flexible urethane foam in certain areas, the Executive Director, Aircraft ■ 1. The authority citation for part 39 which, if exposed to an ignition source, Certification Service, as authorized by continues to read as follows: could cause an uncontrolled fire leading to loss of control of the airplane. FAA Order 8000.51C. In accordance Authority: 49 U.S.C. 106(g), 40113, 44701. with that order, issuance of ADs is (f) Compliance normally a function of the Compliance § 39.13 [Amended] Comply with this AD within the and Airworthiness Division, but during ■ 2. The FAA amends § 39.13 by adding compliance times specified, unless already this transition period, the Executive the following new airworthiness done. Director has delegated the authority to directive (AD): (g) Required Actions issue ADs applicable to transport The Boeing Company: Docket No. FAA– Within 72 months after the effective date category airplanes to the Director of the 2018–0276; Product Identifier 2017– of this AD, do all actions identified as ‘‘RC’’ System Oversight Division. NM–079–AD. (required for compliance) in, and in

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accordance with, the Accomplishment still be done as specified, and the airplane 11.43 and 11.45, by any of the following Instructions of the applicable service can be put back in an airworthy condition. methods: information identified in paragraphs (g)(1), • (j) Related Information Federal eRulemaking Portal: Go to (g)(2), and (g)(3) of this AD. http://www.regulations.gov. Follow the (1) For airplanes identified in paragraph (1) For more information about this AD, instructions for submitting comments. (c)(1) of this AD: Boeing Special Attention contact Scott Craig, Aerospace Engineer, • Cabin Safety and Environmental Systems Fax: 202–493–2251. Service Bulletin 747–53–2877, dated August • 5, 2014. Section, FAA, 2200 South 216th St., Des Mail: U.S. Department of (2) For airplanes identified in paragraph Moines, WA 98198; phone and fax: 206–231– Transportation, Docket Operations, M– (c)(2) of this AD: Boeing Special Attention 3566; email: [email protected]. 30, West Building Ground Floor, Room Service Bulletin 747–25–3646, Revision 1, (2) For service information identified in W12–140, 1200 New Jersey Avenue SE, dated August 2, 2017. this AD, contact Boeing Commercial Washington, DC 20590. (3) For airplanes identified in paragraph Airplanes, Attention: Contractual & Data • Hand Delivery: Deliver to Mail Services (C&DS), 2600 Westminster Blvd., (c)(3) of this AD: Boeing Special Attention address above between 9 a.m. and 5 Service Bulletin 747–25–3692, dated June 22, MC 110–SK57, Seal Beach, CA 90740–5600; 2016. telephone 562–797–1717; internet https:// p.m., Monday through Friday, except www.myboeingfleet.com. You may view this Federal holidays. (h) Credit for Previous Actions referenced service information at the FAA, For service information identified in This paragraph provides credit for the Transport Standards Branch, 2200 South this NPRM, contact Airbus, actions specified in paragraph (g)(2) of this 216th St., Des Moines, WA. For information Airworthiness Office—EIAS, 1 Rond AD, if those actions were performed before on the availability of this material at the Point Maurice Bellonte, 31707 Blagnac the effective date of this AD using Boeing FAA, call 206–231–3195. Cedex, France; telephone +33 5 61 93 36 Special Attention Service Bulletin 747–25– Issued in Des Moines, Washington, on 96; fax +33 5 61 93 44 51; email 3646, dated June 19, 2015. March 29, 2018. [email protected]; (i) Alternative Methods of Compliance Chris Spangenberg, internet http://www.airbus.com. You (AMOCs) Acting Director, System Oversight Division, may view this service information at the (1) The Manager, Seattle ACO Branch, Aircraft Certification Service. FAA, Transport Standards Branch, 2200 FAA, has the authority to approve AMOCs [FR Doc. 2018–07750 Filed 4–16–18; 8:45 am] South 216th St., Des Moines, WA. For for this AD, if requested using the procedures BILLING CODE 4910–13–P information on the availability of this found in 14 CFR 39.19. In accordance with material at the FAA, call 206–231–3195. 14 CFR 39.19, send your request to your principal inspector or local Flight Standards Examining the AD Docket District Office, as appropriate. If sending DEPARTMENT OF TRANSPORTATION information directly to the manager of the You may examine the AD docket on certification office, send it to the attention of Federal Aviation Administration the internet at http:// the person identified in paragraph (j)(1) of www.regulations.gov by searching for this AD. Information may be emailed to: 9- 14 CFR Part 39 and locating Docket No. FAA–2018– [email protected]. [Docket No. FAA–2018–0297; Product 0297; or in person at the Docket (2) Before using any approved AMOC, Identifier 2017–NM–181–AD] Management Facility between 9 a.m. notify your appropriate principal inspector, and 5 p.m., Monday through Friday, or lacking a principal inspector, the manager RIN 2120–AA64 except Federal holidays. The AD docket of the local flight standards district office/ contains this NPRM, the regulatory certificate holding district office. Airworthiness Directives; Airbus evaluation, any comments received, and (3) An AMOC that provides an acceptable Airplanes level of safety may be used for any repair, other information. The street address for modification, or alteration required by this AGENCY: Federal Aviation the Docket Operations office (telephone AD if it is approved by the Boeing Administration (FAA), DOT. 800–647–5527) is in the ADDRESSES Commercial Airplanes Organization ACTION: Notice of proposed rulemaking section. Comments will be available in Designation Authorization (ODA) that has (NPRM). the AD docket shortly after receipt. been authorized by the Manager, Seattle ACO FOR FURTHER INFORMATION CONTACT: Branch, to make those findings. To be SUMMARY: We propose to adopt a new approved, the repair method, modification Sanjay Ralhan, Aerospace Engineer, airworthiness directive (AD) for certain International Section, Transport deviation, or alteration deviation must meet Airbus Model A319 series airplanes; the certification basis of the airplane, and the Standards Branch, FAA, 2200 South approval must specifically refer to this AD. Model A320–211, –212, –214, –231, 216th St., Des Moines, WA 98198; (4) For service information that contains –232, and –233 airplanes; and Model telephone and fax 206–231–3223. A321–111, –112, –131, –211, –212, steps that are labeled as Required for SUPPLEMENTARY INFORMATION: Compliance (RC), the provisions of –213, –231, and –232 airplanes. This paragraphs (i)(4)(i) and (i)(4)(ii) of this AD proposed AD was prompted by Comments Invited apply. investigations that revealed that the We invite you to send any written (i) The steps labeled as RC, including cover seal of the brake dual distribution substeps under an RC step and any figures relevant data, views, or arguments about valve (BDDV) was damaged and did not this proposed AD. Send your comments identified in an RC step, must be done to ensure efficient sealing. This proposed comply with the AD. If a step or substep is to an address listed under the labeled ‘‘RC Exempt,’’ then the RC AD would require identifying the BDDV ADDRESSES section. Include ‘‘Docket No. requirement is removed from that step or part number installed on the airplane, FAA–2018–0297; Product Identifier substep. An AMOC is required for any and modifying or replacing BDDVs 2017–NM–181–AD’’ at the beginning of deviations to RC steps, including substeps having certain part numbers. We are your comments. We specifically invite and identified figures. proposing this AD to address the unsafe comments on the overall regulatory, (ii) Steps not labeled as RC may be condition on these products. deviated from using accepted methods in economic, environmental, and energy DATES: We must receive comments on accordance with the operator’s maintenance aspects of this NPRM. We will consider or inspection program without obtaining this proposed AD by June 1, 2018. all comments received by the closing approval of an AMOC, provided the RC steps, ADDRESSES: You may send comments, date and may amend this NPRM based including substeps and identified figures, can using the procedures found in 14 CFR on those comments.

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We will post all comments we terminating action modification per SB and locating Docket No. FAA–2018– receive, without change, to http:// A320–32–1203. 0297. www.regulations.gov, including any After that [DGAC] AD was issued, Related Service Information Under 1 personal information you provide. We following a new event, Airbus developed a new modification of the BDDV drain tube CFR Part 51 will also post a report summarizing each which leaves it open, ensuring continuous substantive verbal contact we receive drainage of any ingested water, thereby Airbus has issued Service Bulletin about this NPRM. preventing freezing of the brake system. A320–32–1203, Revision 02, dated February 9, 2001. This service Discussion Consequently, EASA issued AD 2014–0251 (later revised), partially retaining the information describes procedures for The European Aviation Safety Agency requirements of DGAC France AD 2000–258– identifying the BDDV part number (EASA), which is the Technical Agent 146, which was superseded, and requiring an installed on the airplane, and modifying for the Member States of the European additional modification of the BDDV drain or replacing BDDVs having certain part Union, has issued EASA Airworthiness tube and re-identification of the BDDV. numbers. Directive 2017–0119, dated July 11, Since EASA AD 2014–0251R1 [which Airbus has also issued Service 2017 (referred to after this as the corresponds to FAA AD 2016–06–13, Amendment 39–18444 (81 FR 17365, dated Bulletin A320–32–1415, Revision 02, Mandatory Continuing Airworthiness March 29, 2016) (‘‘AD 2016–06–13’’)] was dated December 10, 2015. This service Information, or ‘‘the MCAI’’), to correct issued, comments were received that information describes procedures for an unsafe condition for certain Airbus indicated a need for correction and modifying and re-identifying the BDDV. Model A319 series airplanes; Model clarification. Consequently, this [EASA] AD The modification includes modifying A320–211, –212, –214, –231, –232, and retains the requirements of EASA AD 2014– the drain hose of the BDDV, and doing –233 airplanes; and Model A321–111, 0251R1, which is superseded, and expands all related investigative and corrective –112, –131, –211, –212, –213, –231, and the list of BDDV Part Numbers (P/N) which actions if applicable. The related –232 airplanes. The MCAI states: must be removed from service and are no investigative actions include an longer eligible for installation on an In 1998, an operator experienced a dual aeroplane [and includes replacing affected inspection for corrosion. Corrective loss of braking systems. Investigation results part numbers as an option]. This [EASA] AD actions include replacing the BDDV. revealed that the cover seal of the BDDV was also clarifies the intended requirements of This service information is reasonably damaged and did not ensure the sealing EASA AD 2014–0251 and introduces available because the interested parties efficiency. editorial changes, not affecting the have access to it through their normal This condition, if not corrected, could lead requirements. course of business or by the means to water ingestion in the BDDV, freezing of ADDRESSES the BDDV in flight, and consequent loss of Paragraph (1) of the MCAI is identified in the section. braking system function after landing, addressed in paragraphs (e) and (f) of FAA’s Determination and Requirements possibly resulting in damage to the aeroplane FAA AD 2001–15–10; Paragraph (2) of of This Proposed AD and injury to occupants. the MCAI is addressed in paragraph (g) This product has been approved by To address this potential unsafe condition, of FAA AD 2016–06–13. Airbus issued Alert Operator Telex (AOT) the aviation authority of another 32–19 and Service Bulletin (SB) A320–32– This NPRM would not supersede AD country, and is approved for operation 1199, providing instructions for repetitive 2001–15–10 and AD 2016–06–13. in the United States. Pursuant to our functional tests. In addition, Airbus Rather, we have determined that a bilateral agreement with the State of developed mod 28301 and published SB stand-alone AD would be more Design Authority, we have been notified A320–32–1203 to provide modification appropriate to address the changes in instructions. of the unsafe condition described in the the MCAI. This NPRM would require MCAI and service information Consequently, DGAC France issued AD identifying the BDDV part number 2000–258–146 [which corresponds to FAA referenced above. We are proposing this AD 2001–15–10, Amendment 39–12344 (66 installed on the airplane, and modifying AD because we evaluated all pertinent FR 39413, dated July 31, 2001) (‘‘AD 2001– or replacing BDDVs having certain part information and determined an unsafe 15–10’’)] to require repetitive functional tests numbers. condition exists and is likely to exist or as a temporary solution (valid for a period of Doing the proposed actions would develop on other products of these same 15 months) and modification of the BDDV terminate the requirements in type designs. with a new cover and installation of a paragraphs (e) and (f) of AD 2001–15– draining tube with a cap, which was 10, and would terminate all of the Costs of Compliance terminating action for the repetitive requirements of AD 2016–06–13. functional tests. For pre-mod 27833 and pre- We estimate that this proposed AD SB A320–32–1200 aeroplanes, repetitive You may examine the MCAI in the affects 1,136 airplanes of U.S. registry. inspections per SB A320–32–1199 were AD docket on the internet at http:// We estimate the following costs to required as interim action, prior to the www.regulations.gov by searching for comply with this proposed AD:

ESTIMATED COSTS

Cost per Cost on U.S. Action Labor cost Parts cost product operators

Identification and modification or replacement 6 work-hours × $85 per hour = $510 ...... $395 $905 $1,028,080

We have received no definitive data Authority for This Rulemaking Aviation Programs,’’ describes in more that would enable us to provide cost detail the scope of the Agency’s estimates for the on-condition actions Title 49 of the United States Code authority. specified in this proposed AD. specifies the FAA’s authority to issue We are issuing this rulemaking under rules on aviation safety. Subtitle I, the authority described in ‘‘Subtitle VII, section 106, describes the authority of Part A, Subpart III, Section 44701: the FAA Administrator. ‘‘Subtitle VII: General requirements.’’ Under that

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section, Congress charges the FAA with 4. Will not have a significant serial numbers, except those on which promoting safe flight of civil aircraft in economic impact, positive or negative, Airbus Modification 26925 has been air commerce by prescribing regulations on a substantial number of small entities embodied in production, which introduces a for practices, methods, and procedures under the criteria of the Regulatory modified alternate braking system that the Administrator finds necessary for Flexibility Act. removes the brake dual distribution valve safety in air commerce. This regulation (BDDV). List of Subjects in 14 CFR Part 39 is within the scope of that authority (1) Airbus Model A319–111, –112, –113, because it addresses an unsafe condition Air transportation, Aircraft, Aviation –114, –115, –131, –132, and –133 airplanes. that is likely to exist or develop on safety, Incorporation by reference, (2) Airbus Model A320–211, –212, –214, –231, –232, and –233 airplanes. products identified in this rulemaking Safety. (3) Airbus Model A321–111, –112, –131, action. The Proposed Amendment –211, –212, –213, –231, and –232 airplanes. This proposed AD is issued in accordance with authority delegated by Accordingly, under the authority (d) Subject the Executive Director, Aircraft delegated to me by the Administrator, Air Transport Association (ATA) of Certification Service, as authorized by the FAA proposes to amend 14 CFR part America Code 32, Landing gear. FAA Order 8000.51C. In accordance 39 as follows: (e) Reason with that order, issuance of ADs is normally a function of the Compliance PART 39—AIRWORTHINESS This AD was prompted by investigations and Airworthiness Division, but during DIRECTIVES that revealed that the cover seal of the brake this transition period, the Executive dual distribution valve (BDDV) was damaged ■ 1. The authority citation for part 39 Director has delegated the authority to and did not ensure efficient sealing. We are continues to read as follows: issuing this AD to prevent water ingestion in issue ADs applicable to transport the BDDV, freezing of the BDDV in flight, and category airplanes to the Director of the Authority: 49 U.S.C. 106(g), 40113, 44701. consequent loss of braking system function System Oversight Division. § 39.13 [Amended] after landing. These conditions could Regulatory Findings ■ 2. The FAA amends § 39.13 by adding possibly result in damage to the airplane and injury to occupants. We determined that this proposed AD the following new airworthiness would not have federalism implications directive (AD): (f) Compliance under Executive Order 13132. This Airbus: Docket No. FAA–2018–0297; Product Comply with this AD within the proposed AD would not have a Identifier 2017–NM–181–AD. compliance times specified, unless already substantial direct effect on the States, on (a) Comments Due Date done. the relationship between the national We must receive comments by June 1, (g) Identification and Modification or Government and the States, or on the 2018. Replacement distribution of power and responsibilities among the various (b) Affected ADs Within 3 months after the effective date of this AD, identify the BDDV part number levels of government. This AD affects AD 2001–15–10, installed on the airplane. For each affected For the reasons discussed above, I Amendment 39–12344 (66 FR 39413, dated BDDV part number specified in figure 1 to certify this proposed regulation: July 31, 2001) (‘‘AD 2001–15–10’’), and AD 2016–06–13, Amendment 39–18444 (81 FR paragraphs (g) and (h) of this AD, within 3 1. Is not a ‘‘significant regulatory months after the effective date of this AD, do action’’ under Executive Order 12866; 17365, dated March 29, 2016) (‘‘AD 2016–06– 13’’). the actions in paragraph (g)(1), (g)(2), or (g)(3) 2. Is not a ‘‘significant rule’’ under the of this AD. A review of airplane maintenance DOT Regulatory Policies and Procedures (c) Applicability records is acceptable to identify the BDDV (44 FR 11034, February 26, 1979); This AD applies to the airplanes identified part number if the part number of the BDDV 3. Will not affect intrastate aviation in in paragraphs (c)(1) through (c)(3) of this AD, can be conclusively determined from that Alaska; and certificated in any category, all manufacturer review.

(1) Modify and re-identify the affected Revision 02, dated December 10, 2015. Do all Section, Transport Standards Branch, FAA; BDDV, in accordance with the applicable related investigative and or the European Aviation Safety Agency Accomplishment Instructions of Airbus corrective actions before further flight. (EASA); or Airbus’s EASA Design Service Bulletin A320–32–1203, Revision 02, (3) Replace the affected BDDV with a Organization Approval (DOA). If approved by dated February 9, 2001. BDDV having a part number not specified in the DOA, the approval must include the (2) Modify and re-identify the affected figure 1 to paragraphs (g) and (h) of this AD, DOA-authorized signature. BDDV, and do all applicable related or a part number specified as ‘new P/N’ in investigative and corrective, in accordance figure 2 to paragraphs (g)(3) and (h)(2) of this with the Accomplishment Instructions of AD. Do the replacement using a method Airbus Service Bulletin A320–32–1415, approved by the Manager, International

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(h) Parts Installation Prohibition Section, Transport Standards Branch, FAA, Moines, WA 98198; telephone and fax 206– As of the applicable time specified in has the authority to approve AMOCs for this 231–3223. paragraph (h)(1) or (h)(2) of this AD, no AD, if requested using the procedures found (3) For service information identified in person may install a BDDV having a part in 14 CFR 39.19. In accordance with 14 CFR this AD, contact Airbus, Airworthiness number specified in figure 1 to paragraphs (g) 39.19, send your request to your principal Office—EIAS, 1 Rond Point Maurice and (h) of this AD, on any airplane. inspector or local Flight Standards District Bellonte, 31707 Blagnac Cedex, France; (1) For any airplane that, on the effective Office, as appropriate. If sending information telephone +33 5 61 93 36 96; fax +33 5 61 date of this AD, has a BDDV installed with directly to the International Section, send it 93 44 51; email account.airworth-eas@ a part number specified in figure 1 to to the attention of the person identified in airbus.com; internet http://www.airbus.com. paragraphs (g) and (h) of this AD: After paragraph (l)(2) of this AD. Information may You may view this service information at the modification of the airplane, as required by be emailed to: 9-ANM-116-AMOC- FAA, Transport Standards Branch, 2200 paragraph (g) of this AD. [email protected]. Before using any South 216th St., Des Moines, WA. For (2) For any airplane that, on the effective approved AMOC, notify your appropriate information on the availability of this date of this AD, has a BDDV installed with principal inspector, or lacking a principal material at the FAA, call 206–231–3195. inspector, the manager of the local flight a part number specified as ‘new P/N’ in Issued in Des Moines, Washington, on standards district office/certificate holding figure 2 to paragraphs (g)(3) and (h)(2) of this March 30, 2018. district office. AD, or has a BDDV installed with a part Chris Spangenberg, number not specified in figure 1 to (2) Contacting the Manufacturer: For any paragraphs (g) and (h) of this AD: As of the requirement in this AD to obtain corrective Acting Director, System Oversight Division, effective date of this AD. actions from a manufacturer, the action must Aircraft Certification Service. be accomplished using a method approved [FR Doc. 2018–07637 Filed 4–16–18; 8:45 am] (i) Terminating Action for Other ADs by the Manager, International Section, BILLING CODE 4910–13–P (1) Doing the actions in paragraph (g) of Transport Standards Branch, FAA; or the this AD terminates the requirements in European Aviation Safety Agency (EASA); or Airbus’s EASA Design Organization paragraphs (e) and (f) of AD 2001–15–10. DEPARTMENT OF TRANSPORTATION (2) Doing the actions in paragraph (g) of Approval (DOA). If approved by the DOA, the approval must include the DOA- this AD terminates all of the requirements of Federal Aviation Administration AD 2016–06–13. authorized signature. (3) Required for Compliance (RC): If any (j) Credit for Previous Actions service information contains procedures or 14 CFR Part 71 (1) This paragraph provides credit for tests that are identified as RC, those [Docket No. FAA–2018–0101; Airspace actions required by paragraph (g)(1) of this procedures and tests must be done to comply Docket No. 18–AGL–4] AD, if those actions were performed before with this AD; any procedures or tests that are the effective date of this AD using the service not identified as RC are recommended. Those RIN 2120–AA66 information in paragraphs (j)(1)(i) and procedures and tests that are not identified (j)(1)(ii) of this AD. as RC may be deviated from using accepted Proposed Amendment of Class E (i) Airbus Service Bulletin A320–32–1203, methods in accordance with the operator’s Airspace; Lansing, MI dated June 4, 1999, which was incorporated maintenance or inspection program without by reference in AD 2001–15–10. obtaining approval of an AMOC, provided AGENCY: Federal Aviation (ii) Airbus Service Bulletin A320–32–1203, the procedures and tests identified as RC can Administration (FAA), DOT. Revision 01, dated October 12, 2000. be done and the airplane can be put back in ACTION: Notice of proposed rulemaking (2) This paragraph provides credit for an airworthy condition. Any substitutions or actions required by paragraph (g)(2) of this changes to procedures or tests identified as (NPRM). AD, if those actions were performed before RC require approval of an AMOC. SUMMARY: This action proposes to the effective date of this AD using the service (l) Related Information information in paragraphs (j)(2)(i) and amend Class E airspace extending (j)(2)(ii) of this AD. (1) Refer to Mandatory Continuing upward from 700 feet above the surface (i) Airbus Service Bulletin A320–32–1415, Airworthiness Information (MCAI) EASA at Capital Region International Airport, dated September 2, 2014, which was Airworthiness Directive 2017–0119, dated Lansing, MI. The FAA is proposing this incorporated by reference in AD 2016–06–13. July 11, 2017, for related information. This action as a result of an airspace review (ii) Airbus Service Bulletin A320–32–1415, MCAI may be found in the AD docket on the do to the decommissioning of the Revision 01, dated April 23, 2015. internet at http://www.regulations.gov by Lansing VHF omnidirectional range searching for and locating Docket No. FAA– (k) Other FAA AD Provisions 2018–0297. (VOR) navigation aid as part of the VOR The following provisions also apply to this (2) For more information about this AD, Minimum Operational Network (MON) AD: contact Sanjay Ralhan, Aerospace Engineer, Program. The geographic coordinates (1) Alternative Methods of Compliance International Section, Transport Standards and name of the airport would also be (AMOCs): The Manager, International Branch, FAA, 2200 South 216th St., Des updated to coincide with the FAA’s

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aeronautical database. An editorial of airspace necessary to ensure the Operations Support Group, 10101 change would also be made to the legal safety of aircraft and the efficient use of Hillwood Parkway, Fort Worth, TX designation by removing the city from airspace. This regulation is within the 76177. the airport name. scope of that authority as it would Availability and Summary of amend Class E airspace extending DATES: Comments must be received on Documents for Incorporation by upward from 700 feet above the surface or before June 1, 2018. Reference ADDRESSES: Send comments on this at Capital Region International Airport, proposal to the U.S. Department of Lansing, MI, to support instrument This document proposes to amend Transportation, Docket Operations, flight rule operations. FAA Order 7400.11B, Airspace Designations and Reporting Points, West Building Ground Floor, Room Comments Invited W12–140, 1200 New Jersey Avenue SE, dated August 3, 2017, and effective Interested parties are invited to Washington, DC 20590; telephone (202) September 15, 2017. FAA Order participate in this proposed rulemaking 366–9826, or (800) 647–5527. You must 7400.11B is publicly available as listed by submitting such written data, views, in the ADDRESSES section of this identify FAA Docket No. FAA–2018– or arguments, as they may desire. 0101; Airspace Docket No. 18–AGL–4, document. FAA Order 7400.11B lists Comments that provide the factual basis Class A, B, C, D, and E airspace areas, at the beginning of your comments. You supporting the views and suggestions may also submit comments through the air traffic service routes, and reporting presented are particularly helpful in points. internet at http://www.regulations.gov. developing reasoned regulatory You may review the public docket decisions on the proposal. Comments The Proposal containing the proposal, any comments are specifically invited on the overall The FAA is proposing an amendment received, and any final disposition in regulatory, aeronautical, economic, to Title 14, Code of Federal Regulations person in the Dockets Office between environmental, and energy-related (14 CFR) part 71 by amending the Class 9:00 a.m. and 5:00 p.m., Monday aspects of the proposal. E airspace extending upward from 700 through Friday, except Federal holidays. Communications should identify both feet above the surface to within a 6.8- FAA Order 7400.11B, Airspace docket numbers and be submitted in mile radius (increased from a 6.7-mile Designations and Reporting Points, and triplicate to the address listed above. radius) at Capital Region International subsequent amendments can be viewed _ Commenters wishing the FAA to Airport (formerly Capital City Airport), online at http://www.faa.gov/air traffic/ acknowledge receipt of their comments Lansing, MI; removing the extension to publications/. For further information, on this notice must submit with those the east of the airport associated with you can contact the Airspace Policy comments a self-addressed, stamped the ARTDA LOM; adding an extension Group, Federal Aviation postcard on which the following within 2 miles each side of the 091° Administration, 800 Independence statement is made: ‘‘Comments to bearing from the airport from the 6.8- Avenue SW, Washington, DC 20591; Docket No. FAA–2018–0101; Airspace mile radius to 10.4 mile east of the telephone: (202) 267–8783. The Order is Docket No. 18–AGL–4.’’ The postcard airport; and adding an extension within also available for inspection at the will be date/time stamped and returned 4 miles each side of the 233° from the National Archives and Records to the commenter. airport from the 6.8-mile radius to 10.5 Administration (NARA). For All communications received before miles southwest of the airport. information on the availability of FAA the specified closing date for comments The name of the airport would also be Order 7400.11B at NARA, call (202) will be considered before taking action updated from Capital City Airport to 741–6030, or go to http:// on the proposed rule. The proposal Capital Region International Airport, www.archives.gov/federal-register/cfr/ contained in this notice may be changed and the geographic coordinates of the ibr-locations.html. in light of the comments received. A airport would be updated to coincide FAA Order 7400.11, Airspace report summarizing each substantive with the FAA’s aeronautical database. Designations and Reporting Points, is public contact with FAA personnel Additionally, an editorial change would published yearly and effective on concerned with this rulemaking will be be made removing the name of the city September 15. filed in the docket. associated with the airport in the legal FOR FURTHER INFORMATION CONTACT: Availability of NPRMs designation to comply with a recent Jeffrey Claypool, Federal Aviation change to FAA Order 7400.2L, Administration, Operations Support An electronic copy of this document Procedures for Handling Airspace Group, Central Service Center, 10101 may be downloaded through the Matters. Hillwood Parkway, Fort Worth, TX internet at http://www.regulations.gov. This action is necessary as the result 76177; telephone (817) 222–5711. Recently published rulemaking of airspace review do to the SUPPLEMENTARY INFORMATION: documents can also be accessed through decommissioning of the Lansing VOR as the FAA’s web page at http:// Authority for This Rulemaking part of the VOR MON Program. www.faa.gov/air_traffic/publications/ Class E airspace designations are The FAA’s authority to issue rules airspace_amendments/. published in paragraph 6005 of FAA regarding aviation safety is found in You may review the public docket Order 7400.11B, dated August 3, 2017, Title 49 of the United States Code. containing the proposal, any comments and effective September 15, 2017, which Subtitle I, Section 106 describes the received, and any final disposition in is incorporated by reference in 14 CFR authority of the FAA Administrator. person in the Dockets Office (see the 71.1. The Class E airspace designation Subtitle VII, Aviation Programs, ADDRESSES section for the address and listed in this document will be describes in more detail the scope of the phone number) between 9:00 a.m. and published subsequently in the Order. agency’s authority. This rulemaking is 5:00 p.m., Monday through Friday, promulgated under the authority except federal holidays. An informal Regulatory Notices and Analyses described in Subtitle VII, Part A, docket may also be examined during The FAA has determined that this Subpart I, Section 40103. Under that normal business hours at the Federal regulation only involves an established section, the FAA is charged with Aviation Administration, Air Traffic body of technical regulations for which prescribing regulations to assign the use Organization, Central Service Center, frequent and routine amendments are

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necessary to keep them operationally the 6.8-mile radius to 10.4 mile east of the Administration, 800 Independence current, is non-controversial and airport, and within 4.0 miles each side of the Avenue SW, Washington, DC 20591; ° unlikely to result in adverse or negative 233 bearing from the airport extending from telephone: (202) 267–8783. The Order is comments. It, therefore: (1) Is not a the 6.8-mile radius to 10.5 miles southwest also available for inspection at the of the airport. ‘‘significant regulatory action’’ under National Archives and Records Executive Order 12866; (2) is not a Issued in Fort Worth, Texas, on April 9, Administration (NARA). For ‘‘significant rule’’ under DOT 2018. information on the availability of FAA Regulatory Policies and Procedures (44 Christopher L. Southerland, Order 7400.11B at NARA, call (202) FR 11034; February 26, 1979); and (3) Acting Manager, Operations Support Group, 741–6030, or go to https:// does not warrant preparation of a ATO Central Service Center. www.archives.gov/federal-register/cfr/ regulatory evaluation as the anticipated [FR Doc. 2018–07903 Filed 4–16–18; 8:45 am] ibr-locations.html. impact is so minimal. Since this is a BILLING CODE 4910–13–P FAA Order 7400.11, Airspace routine matter that will only affect air Designations and Reporting Points, is traffic procedures and air navigation, it published yearly and effective on is certified that this rule, when DEPARTMENT OF TRANSPORTATION September 15. promulgated, would not have a FOR FURTHER INFORMATION CONTACT: significant economic impact on a Federal Aviation Administration Colby Abbott, Airspace Policy Group, substantial number of small entities Office of Airspace Services, Federal under the criteria of the Regulatory 14 CFR Part 71 Aviation Administration, 800 Flexibility Act. [Docket No. FAA–2018–0280; Airspace Independence Avenue SW, Washington, Docket No. 17–AGL–27] DC 20591; telephone: (202) 267–8783. Environmental Review SUPPLEMENTARY INFORMATION: This proposal will be subject to an RIN 2120–AA66 Authority for This Rulemaking environmental analysis in accordance Proposed Amendment of VOR Federal with FAA Order 1050.1F, Airways V–170 and V–219 in the The FAA’s authority to issue rules ‘‘Environmental Impacts: Policies and Vicinity of Fairmont, MN regarding aviation safety is found in Procedures’’ prior to any FAA final Title 49 of the United States Code. regulatory action. AGENCY: Federal Aviation Subtitle I, Section 106 describes the Administration (FAA), DOT. authority of the FAA Administrator. List of Subjects in 14 CFR Part 71 ACTION: Notice of proposed rulemaking Subtitle VII, Aviation Programs, Airspace, Incorporation by reference, (NPRM). describes in more detail the scope of the Navigation (air). agency’s authority. This rulemaking is SUMMARY: The Proposed Amendment This action proposes to promulgated under the authority amend VHF Omnidirectional Range described in Subtitle VII, Part A, Accordingly, pursuant to the (VOR) Federal airways V–170 and V– Subpart I, Section 40103. Under that authority delegated to me, the Federal 219 in the vicinity of Fairmont, MN. section, the FAA is charged with Aviation Administration proposes to The modifications are necessary due to prescribing regulations to assign the use amend 14 CFR part 71 as follows: the planned decommissioning of the of the airspace necessary to ensure the Fairmont, MN (FRM), VOR navigation safety of aircraft and the efficient use of PART 71—DESIGNATION OF CLASS A, aid (NAVAID), which provides airspace. This regulation is within the B, C, D, AND E AIRSPACE AREAS; AIR navigation guidance for portions of the scope of that authority as it would TRAFFIC SERVICE ROUTES; AND affected air traffic service (ATS) routes. modify the route structure as necessary REPORTING POINTS The Fairmont VOR is being to preserve the safe and efficient flow of ■ 1. The authority citation for 14 CFR decommissioned as part of the VOR air traffic within the National Airspace part 71 continues to read as follows: Minimum Operational Network (MON) System. program. Authority: 49 U.S.C. 106(f), 106(g); 40103, Comments Invited 40113, 40120; E.O. 10854, 24 FR 9565, 3 CFR, DATES: Comments must be received on Interested parties are invited to 1959–1963 Comp., p. 389. or before June 1, 2018. participate in this proposed rulemaking § 71.1 [Amended] ADDRESSES: Send comments on this by submitting such written data, views, proposal to the U.S. Department of ■ 2. The incorporation by reference in or arguments as they may desire. Transportation, Docket Operations, 1200 14 CFR 71.1 of FAA Order 7400.11B, Comments that provide the factual basis New Jersey Avenue SE, West Building Airspace Designations and Reporting supporting the views and suggestions Ground Floor, Room W12–140, Points, dated August 3, 2017, and presented are particularly helpful in Washington, DC 20590; telephone: effective September 15, 2017, is developing reasoned regulatory 1(800) 647–5527, or (202) 366–9826. amended as follows: decisions on the proposal. Comments You must identify FAA Docket No. are specifically invited on the overall Paragraph 6005 Class E Airspace Areas FAA–2018–0280; Airspace Docket No. regulatory, aeronautical, economic, Extending Upward From 700 Feet or More 17–AGL–27 at the beginning of your environmental, and energy-related Above the Surface of the Earth. comments. You may also submit aspects of the proposal. * * * * * comments through the internet at http:// Communications should identify both AGL MI E5 Lansing, MI [Amended] www.regulations.gov. docket numbers (FAA Docket No. FAA– FAA Order 7400.11B, Airspace 2018–0280; Airspace Docket No. 17– Capital Region International Airport, MI (Lat. 42°46′43″ N, long. 84°35′10″ W) Designations and Reporting Points, and AGL–27) and be submitted in triplicate subsequent amendments can be viewed to the Docket Management Facility (see That airspace extending upward from 700 _ feet above the surface within a 6.8-mile online at http://www.faa.gov/air traffic/ ADDRESSES section for address and radius of Capital Region International publications/. For further information, phone number). You may also submit Airport, and within 2.0 miles each side of the you can contact the Airspace Policy comments through the internet at http:// 091° bearing from the airport extending from Group, Federal Aviation www.regulations.gov.

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Commenters wishing the FAA to discontinuance by the FAA’s VOR MON now proposes to remove the airway acknowledge receipt of their comments program and listed in the final policy segment between the Worthington, MN, on this action must submit with those statement notice, ‘‘Provision of VOR/DME and the Rochester, MN, comments a self-addressed, stamped Navigation Services for the Next VOR/DME. The unaffected portions of postcard on which the following Generation Air Transportation System the existing airway would remain as statement is made: ‘‘Comments to FAA (NextGen) Transition to Performance- charted. Docket No. FAA–2018–0280; Airspace Based Navigation (PBN) (Plan for V–219: V–219 currently extends Docket No. 17–AGL–27.’’ The postcard Establishing a VOR Minimum between the Hayes Center, NE, VORTAC will be date/time stamped and returned Operational Network),’’ published in the and the Mankato, MN, VOR/DME. The to the commenter. Federal Register of July 26, 2016 (81 FR FAA proposes to remove the airway All communications received on or 48694), Docket No. FAA–2011–1082. segment between the Sioux City, IA, before the specified comment closing Although the VOR portion of the VORTAC and the Mankato, MN, VOR/ date will be considered before taking Fairmont, MN, VOR/Distance Measuring DME. The unaffected portions of the action on the proposed rule. The Equipment (DME) NAVAID is planned existing airway would remain as proposal contained in this action may for decommissioning, the DME portion charted. be changed in light of comments is being retained. The ATS routes All radials in the route descriptions received. All comments submitted will effected by the Fairmont VOR are VOR below are unchanged and stated in True be available for examination in the Federal airways V–170 and V–219. degrees. public docket both before and after the With the planned decommissioning of VOR Federal airways are published in comment closing date. A report the Fairmont VOR, the remaining paragraph 6010(a) of FAA Order summarizing each substantive public ground-based NAVAID coverage in the 7400.11B dated August 3, 2017, and contact with FAA personnel concerned area is insufficient to enable the effective September 15, 2017, which is with this rulemaking will be filed in the continuity of the affected airways. As incorporated by reference in 14 CFR docket. such, proposed modifications to V–170 71.1. The VOR Federal airways listed in and V–219 would result in gaps in the this document would be subsequently Availability of NPRMs route structures. To overcome the gaps, published in the Order. An electronic copy of this document instrument flight rules (IFR) traffic may be downloaded through the could use adjacent VOR Federal airways Regulatory Notices and Analyses internet at http://www.regulations.gov. V–24, V–250, and V–398 between the The FAA has determined that this Recently published rulemaking Worthington, MN, VOR/DME and proposed regulation only involves an documents can also be accessed through Rochester, MN, VOR/DME or Federal established body of technical the FAA’s web page at http:// airways V–100, V–175, V–250, and V– regulations for which frequent and www.faa.gov/air_traffic/publications/ 456 between the Sioux City, IA, VOR/ routine amendments are necessary to airspace_amendments/. Tactical Air Navigation (VORTAC) and keep them operationally current. It, You may review the public docket Mankato, MN, VOR/DME to therefore: (1) Is not a ‘‘significant containing the proposal, any comments circumnavigate the affected area. regulatory action’’ under Executive received and any final disposition in Additionally, IFR traffic could file point Order 12866; (2) is not a ‘‘significant person in the Dockets Office (see to point through the affected area using rule’’ under Department of ADDRESSES section for address and fixes that will remain in place, or Transportation (DOT) Regulatory phone number) between 9:00 a.m. and receive air traffic control (ATC) radar Policies and Procedures (44 FR 11034; 5:00 p.m., Monday through Friday, vectors through the area. Visual flight February 26, 1979); and (3) does not except Federal holidays. An informal rules pilots who elect to navigate via the warrant preparation of a regulatory docket may also be examined during airways through the affected area could evaluation as the anticipated impact is normal business hours at the office of also take advantage of the adjacent VOR so minimal. Since this is a routine the Operations Support Group, Central Federal airways or ATC services listed matter that will only affect air traffic Service Center, Federal Aviation previously. procedures and air navigation, it is Administration, 10101 Hillwood Blvd., The Proposal certified that this proposed rule, when Fort Worth, TX 76177. promulgated, will not have a significant The FAA is proposing an amendment economic impact on a substantial Availability and Summary of to Title 14, Code of Federal Regulations Documents for Incorporation by number of small entities under the (14 CFR) part 71 to modify VOR Federal criteria of the Regulatory Flexibility Act. Reference airways V–170 and V–219. The planned This document proposes to amend decommissioning of the Fairmont, MN, Environmental Review FAA Order 7400.11B, Airspace VOR has made these actions necessary. This proposal will be subject to an Designations and Reporting Points, The proposed VOR Federal airway environmental analysis in accordance dated August 3, 2017, and effective changes are outlined below. with FAA Order 1050.1F, September 15, 2017. FAA Order V–170: V–170 currently extends ‘‘Environmental Impacts: Policies and 7400.11B is publicly available as listed between the Devils Lake, ND, VOR/DME Procedures’’ prior to any FAA final in the ADDRESSES section of this and the Salem, MI VORTAC; and regulatory action. document. FAA Order 7400.11B lists between the Erie, PA, VORTAC and the Class A, B, C, D, and E airspace areas, intersection of the Andrews 060° and List of Subjects in 14 CFR Part 71 air traffic service routes, and reporting Baltimore, MD, 165° radials (POLLA Airspace, Incorporation by reference, points. fix); excluding the airspace within R– Navigation (air). 5802 when active. In a separate Background rulemaking action, the FAA is removing The Proposed Amendment The FAA is planning the airway segment between the Erie, In consideration of the foregoing, the decommissioning activities for the PA, VORTAC and the Bradford, PA, Federal Aviation Administration Fairmont, MN (FRM), VOR in 2019 as VOR/DME effective May 24, 2018 (83 proposes to amend 14 CFR part 71 as one of the candidate VORs identified for FR 13404, March 29, 2018). The FAA follows:

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PART 71—DESIGNATION OF CLASS A, SUMMARY: The U.S. Department of the Secretary of the Interior’s responsibility B, C, D, AND E AIRSPACE AREAS; AIR Interior is announcing the proposed to define standards, assessments, and an TRAFFIC SERVICE ROUTES; AND members to form the Bureau of Indian accountability system for Bureau- REPORTING POINTS Education (BIE) Standards, funded schools. The Committee will Assessments, and Accountability recommend regulations that will replace ■ 1. The authority citation for part 71 System Negotiated Rulemaking the existing regulations at 25 CFR part continues to read as follows: Committee (Committee) which will 30 and implement the Secretary’s new Authority: 49 U.S.C. 106(f), 106(g); 40103, advise the Secretary of the Interior statutory responsibility to define 40113, 40120; E.O. 10854, 24 FR 9565, 3 CFR, (Secretary) through the BIE on a standards, assessments, and an 1959–1963 Comp., p. 389. proposed rule to revise the Adequate accountability system for Bureau- Yearly Progress regulation as previously funded schools consistent with ESEA § 71.1 [Amended] announced in the Federal Register. This section 1111, as amended, on a national, ■ 2. The incorporation by reference in notice solicits comments on the regional, or Tribal basis, as appropriate, 14 CFR 71.1 of FAA Order 7400.11B, proposed membership, and invites taking into account the unique Airspace Designations and Reporting additional nominations for Committee circumstances and needs of such Points, dated August 3, 2017 and members who will adequately represent schools and the students served by such effective September 15, 2017, is the interests that are likely to be schools. amended as follows: significantly affected by the proposed ESEA section 8204 also provides that if a Tribal governing body or school Paragraph 6010(a) Domestic VOR Federal rule. The Secretary also proposes to Airways. appoint Federal representatives to the board of a Bureau-funded school Committee as listed. determines the requirements established * * * * * by the Secretary of the Interior are DATES: Comments must be submitted no V–170 [Amended] later than May 17, 2018. inappropriate, they may waive, in part From Devils Lake, ND; INT Devils Lake or in whole, such requirements. Where ADDRESSES: Send comments and 187° and Jamestown, ND, 337° radials; such requirements are waived, the Jamestown; Aberdeen, SD; Sioux Falls, SD; to nominations to the Designated Federal Tribal governing body or school board Worthington, MN. From Rochester, MN; Officer, Ms. Sue Bement, Education must, within 60 days, submit to the Nodine, MN; Dells, WI; INT Dells 097° and Program Specialist, Bureau of Indian Secretary of the Interior a proposal for Badger, WI, 304° radials; Badger; INT Badger Education, by any of the following alternative standards, assessments, and 121° and Pullman, MI, 282° radials; Pullman; methods: • an accountability system, if applicable, to Salem, MI. From Bradford, PA; Slate Run, (Preferred method) Email to: consistent with ESEA section 1111. The PA; Selinsgrove, PA; Ravine, PA; INT Ravine [email protected]; proposal will be approved by the 125° and Modena, PA, 318° radials; Modena; • Mail, hand-carry or use an Dupont, DE; INT Dupont 223° and Andrews, Secretary of the Interior and the ° ° overnight courier service to the Secretary of Education, unless the MD, 060 radials; to INT Andrews 060 and Designated Federal Officer, Ms. Sue Baltimore, MD, 165° radials. The airspace proposed standards, assessments, and within R–5802 is excluded when active. Bement, c/o The Office of Regulatory accountability system do not meet the Affairs and Collaborative Action, 1001 * * * * * requirements of ESEA section 1111, Indian School Road NW, Suite 312, taking into account the unique V–219 [Amended] Albuquerque, NM 87104. circumstances and needs of such school From Hayes Center, NE; INT Hayes Center FOR FURTHER INFORMATION CONTACT: The or schools and the students served. 059° and Wolbach, NE, 251° radials; Designated Federal Officer, Ms. Sue Additionally, a Tribal governing body or Wolbach; Norfolk, NE; to Sioux City, IA. Bement, Bureau of Indian Education; school board of a Bureau-funded school Issued in Washington, DC, on April 9, email: [email protected]; phone: seeking a waiver may request, technical 2018. (952) 851–5427. assistance from the Secretary of the Rodger A. Dean Jr., SUPPLEMENTARY INFORMATION: Interior and the Secretary of Education. Manager, Airspace Policy Group. Background Proposed Work of the Committee [FR Doc. 2018–07902 Filed 4–16–18; 8:45 am] The purpose of the BIE Committee is The objectives of the Committee are to BILLING CODE 4910–13–P to serve as an advisory committee under represent the interests that will be the Federal Advisory Committee Act significantly affected by the final (FACA) and the Negotiated Rulemaking regulations, negotiate in good faith, and DEPARTMENT OF THE INTERIOR Act (NRA). Pursuant to the Federal reach consensus, where possible, on Bureau of Indian Affairs Register notice of intent (82 FR 43199), recommendations to the Secretary for the Secretary has selected 13 Tribal the proposed regulations. The Committee will be charged, 25 CFR Part 30 representatives and 5 Federal representatives for the Committee, for a consistent with ESEA section 8204, with [189A2100DD/AAKC001030/ proposed total of 18 members. developing draft regulations to A0A501010.999900 253G] implement the Secretary’s responsibility Every Student Succeeds Act to define the standards, assessments, Bureau of Indian Education Standards, The Every Student Succeeds Act and an accountability system, consistent Assessments, and Accountability (ESSA) reauthorizes and amends the with ESEA Section 1111, for Bureau- System Negotiated Rulemaking Elementary and Secondary Education funded schools. The draft regulations Committee Establishment; Proposed Act of 1965 (ESEA). ESEA Section 8204, will be considered by the Secretary and Membership as amended by ESSA directs the subject to government-to-government AGENCY: Bureau of Indian Affairs, Secretary of the Interior, in consultation consultation. As a part of its Interior. with the Secretary of Education, if so deliberations, the Committee will requested, to use a negotiated consider the appropriate scope of the ACTION: Proposed membership of rulemaking process to develop draft regulations, e.g., national, regional, Committee and request for nominations. regulations for implementation of the or Tribal basis, as appropriate, taking

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into account the unique circumstances to three days in length. The BIE has alternate to serve when the and needs of such schools and the dedicated resources required to: Ensure representative is unavailable for students served by such schools, and the Committee is able to conduct membership on the Committee. The BIE how BIE will implement such meetings, provide technical assistance, also invited nominations for Committee regulations. and provide any additional support members who will adequately represent The BIE encourages Tribal self- required to fulfill the Committee’s the interests that are likely to be determination in Native education, by responsibilities. significantly affected by the proposed encouraging governing Tribes or school Proposed Tribal Committee Members rule such as: Students enrolled, or boards to develop alternative standards, parents of students enrolled at the 174 assessments, and an accountability On September 14, 2017, the BIE Bureau-funded schools, school teachers, system, and by providing technical published a Federal Register notice of and administrators, Tribes, and Indian assistance. Therefore, the Committee intent (82 FR 43199) requesting communities served by these schools. will also be asked to provide comments and nominations for Tribal The proposed Committee was selected recommendations on how the BIE could representatives for the Committee. The based upon nominations submitted best provide technical assistance under comment period for that notice of intent ESEA section 8204 to Tribes who opt to closed October 16, 2017. through the process identified in the exercise their authority to waive in part Within the notice, the BIE solicited Federal Register (82 FR 43199) dated or in whole the Secretary’s definition of comments on the proposal to establish September 14, 2017, under the standards, assessments, and the Committee, including comments on ‘‘Nominations’’ section. The Secretary accountability system. any additional interests not identified. did not consider nominations that were Since the contemplated regulations The BIE solicited nominations from received in any other manner or were must be in place as soon as possible, the Tribes whose students attend Bureau- received after the close of the comment Committee will be expected to meet funded schools operated by either BIE period. frequently within a short time frame. or by the Tribe through a contract or The Secretary proposes the following The BIE currently anticipates up to four grant who would be affected by the final Tribal representatives for the meetings, with each meeting lasting two rule to nominate a representative and Committee:

Proposed committee member Nominated by

Gloria Coats-Kitsopoulos, Superintendent, American Horse School ...... Oglala Sioux Tribe (South Dakota). Charles Cuny, Superintendent, Little Wound School ...... Oglala Sioux Tribe (South Dakota). Michael Debrieo, Principal, Kha’p’o Community School ...... Santa Clara Indian Pueblo (New Mexico). Ronald Etheridge, Deputy Executive Director of Education Services, Cherokee Intertribal Council of the Five Civilized Tribes (Oklahoma). Nation. Leslie Harper-Liberty, Government Relations Specialist, Leech Lake Band of Leech Lake Band of Ojibwe (Minnesota). Ojibwe. Tommy Lewis, Jr., Superintendent of Schools, Navajo Nation ...... National Indian Education Association (Arizona). Jennifer Lynn McLeod Tyson, Tribal Councilwoman, Sault Ste. Marie Tribe of Sault Ste. Marie Tribe of Chippewa Indians (Michigan). Chippewa Indians. Patricia Sandoval, Director of Planning and Evaluation, Santa Fe Indian School ... Pueblo of Laguna (New Mexico). Delima ‘‘Bonnie’’ Rose Payer, Teacher, Ojibwa Indian School on the Turtle Moun- American Federation of Teachers (North Dakota). tain Reservation. Richard St. Germaine, Commissioner, Education for the Mille Lacs Band of Mille Lacs Band of Ojibwe (Minnesota). Ojibwe. Sherry Tubby, Exceptional Education Coordinator, Choctaw Tribal Schools ...... Mississippi Band of Choctaw Indians (Mississippi).

The Secretary proposes the following alternate Tribal representatives for the Committee:

Proposed alternate committee member Nominated by

Lucinda Campbell, Lukachukai Community Board of Education, Inc...... Dine´ Grant Schools Association (Arizona). Franklin No Runner, Superintendent, St. Stephens Indian School ...... Northern Arapaho Business Council (Wyoming).

Proposed Federal Committee Members Bureau of Indian Education. The Federal representatives for the The Designated Federal Officer for the Secretary proposes the following Committee: Committee will be Ms. Sue Bement,

Name Affiliation

Jeffrey Hamley, Associate Deputy Director, Division of Performance and Account- Bureau of Indian Education. ability. Lora Braucher, Superintendent, Chemawa Indian School ...... Bureau of Indian Education. Brian Quint, Attorney-Advisor ...... Office of the Solicitor.

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The Secretary proposes the following alternate Federal representatives for the Committee:

Name Affiliation

Jimmy Hastings, Education Program Administrator ...... Bureau of Indian Education. Brenda Riel, Attorney-Advisor ...... Office of the Solicitor.

Comments reach agreement on behalf of the the location indicated in the ADDRESSES The Secretary solicited comments on interest(s); section. • Are able to negotiate effectively on the proposal to establish the Committee III. Public Disclosure of Comments behalf of the interest(s) represented; and received one response from the • Before including your address, phone National Indian Education Association Are able to commit the time and effort required to attend and prepare for number, email address, or other (NIEA) that was submitted through the personal identifying information in your process identified in the Federal meetings; and • comment, you should be aware that Register (82 FR 43199) dated September Are able to collaborate among diverse parties in a consensus-seeking your entire nomination submission— 14, 2017. The Secretary did not consider including your personal identifying comments that were received in any process. The Secretary will consider information—may be made publically other manner or were received after the available at any time. While you can ask close of the comment period. nominations for representatives only if they are nominated through the process us in your submission to withhold your The comments received from NIEA: personal identifying information from (1) Support the proposal to form a identified in this Notice and in the Federal Register Notice of Intent (82 FR public review, we cannot guarantee that negotiated rulemaking committee, (2) we will be able to do so. encourage the Secretary to include 43199). The Secretary will not consider Native educators, researchers, and any nominations received in any other Authority: The Elementary and Secondary evaluators on the Committee, and (3) manner. The Secretary will not consider Education Act of 1965, as amended, 20 U.S.C. 6301 et seq. encourage the Secretary to ensure that nominations for Federal representatives; representatives are served by Bureau- only the Secretary may nominate Dated: April 9, 2018. funded schools. Federal employees to the Committee. John Tahsuda, Both the Secretary and the BIE believe Nominations must include the Principal Deputy Assistant Secretary—Indian the proposed representatives address following information about each Affairs, Exercising the Authority of the NIEA’s comments to ensure the Native nominee: Assistant Secretary—Indian Affairs. students are best supported and (1) A current letter from the entity [FR Doc. 2018–07922 Filed 4–16–18; 8:45 am] evaluated holistically. The proposed representing one of the interest(s) BILLING CODE 4337–15–P representatives carry a wide range of identified supporting the nomination of experiences, knowledge, and the individual to serve as a understanding to support Native representative for the Committee; DEPARTMENT OF HOMELAND students both academically and (2) A resume reflecting the nominee’s SECURITY culturally. qualifications and experience in Indian education; resume to include the Coast Guard Nominations nominee’s name, Tribal affiliation (if If you are a Tribe with Bureau-funded applicable), job title, major job duties, 33 CFR Part 100 employer, business address, business schools, an Indian education [Docket Number USCG–2018–0320] organization, or an interested telephone and fax numbers (and individual, we invite you to comment business email address, if applicable); RIN 1625–AA08 on the proposed nominations in this (3) The interest(s) to be represented by notice or to nominate other persons for the nominee identified in Section V, in Special Local Regulation; membership on the Committee. The the Federal Register (82 FR 43199) Monongahela River (MM 0.22), Committee membership should reflect published September 14, 2017, and Allegheny River (MM 0.8), and Ohio the diversity of Tribal interests, and whether the nominee will represent River (0.8), Pittsburgh, PA. Tribes should nominate representatives other interest(s) related to this AGENCY: Coast Guard, DHS. rulemaking; and alternates who will: ACTION: Notice of proposed rulemaking. • Have knowledge of school (4) A brief description of how the standards, assessments, and nominee will represent the views of the SUMMARY: The Coast Guard proposes to accountability systems; identified interest(s), communicate with establish a special local regulation for • Have relevant experiences as past or constituents, and have a clear means to certain navigable waters of the present superintendents, principals, reach agreement on behalf of the Allegheny, Monongahela, and Ohio teachers, or school board members; interest(s) they are representing; and Rivers in the vicinity of Pittsburgh, PA. • Are able to coordinate, to the extent (5) A statement on whether the This action is necessary to provide for possible, with other interests who may nominee is only representing one the safety of life on these navigable not be represented on the Committee; interest or whether the expectation is waters during the weekend of the Luke • Are able to represent one or more of that the nominee represents a specific Bryan concert at Heinz Field. This the specified interests with the authority group of interests. proposed rulemaking would prohibit to embody the views of that or those To be considered, nominations must persons and vessels from loitering, interest(s), communicate with interested be received by the close of business on anchoring, stopping, mooring, constituents, and have a clear means to the date listed in the DATES section, at remaining, or drifting in any manner

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that impedes safe passage of another determined that this special local COTP or a designated representative. In vessel to any launching ramp, marina, regulation is necessary to maintain an addition, no vessel or person would be or fleeting area unless authorized by the open navigation channel and ensure the permitted to loiter, anchor, stop, remain, Captain of the Port Marine Safety Unit safety of vessels and these navigable or drift more than 100 feet from any Pittsburgh or a designated waters during the concert weekend. riverbank unless authorized by the representative. In addition, this The purpose of this rulemaking is to COTP or a designated representative. proposed rulemaking would prohibit ensure the safety of vessels and the They may be contacted on VHF–FM persons and vessels from loitering, navigable waters adjacent to Heinz Field Channel 16. Persons and vessels anchoring, stopping, or drifting more on the Allegheny, Monongahela, and permitted to enter this regulated area than 100 feet from any river bank unless Ohio Rivers before, during, and after the must transit at their slowest safe speed authorized by the Captain of the Port Luke Bryan concert weekend. The Coast and comply with all lawful directions Marine Safety Unit Pittsburgh or a Guard proposes this rulemaking under issued by the COTP or the designated designated representative. We invite authority in 33 U.S.C. 1233. representative. The regulatory text we your comments on this proposed The Coast Guard is issuing this notice are proposing appears at the end of this rulemaking. of proposed rulemaking (NPRM) with a document. 15-day prior notice and opportunity to DATES: Comments and related material comment pursuant to section (b)(3) of IV. Regulatory Analyses must be received by the Coast Guard on the Administrative Procedure Act (APA) We developed this proposed rule after or before May 2, 2018. (5 U.S.C. 553). This provision authorizes considering numerous statutes and ADDRESSES: You may submit comments an agency to publish a rule in less than Executive orders related to rulemaking. identified by docket number USCG– 30 days before its effective date for Below we summarize our analyses 2018–0320 using the Federal ‘‘good cause found and published with based on a number of these statutes and eRulemaking Portal at http:// the rule.’’ Under 5 U.S.C. 553(b)(3)(B), Executive orders and we discuss First www.regulations.gov. See the ‘‘Public the Coast Guard finds that good cause Amendment rights of protestors. Participation and Request for exists for publishing this NPRM with a A. Regulatory Planning and Review Comments’’ portion of the 15-day comment period because it is SUPPLEMENTARY INFORMATION section for impractical to provide a 30-day Executive Orders 12866 and 13563 further instructions on submitting comment period. This proposed special direct agencies to assess the costs and comments. local regulation is necessary to ensure benefits of available regulatory alternatives and, if regulation is FOR FURTHER INFORMATION CONTACT: If the safety of vessels and persons during necessary, to select regulatory you have questions about this proposed the concert weekend. It is impracticable approaches that maximize net benefits. rulemaking, call or email Petty Officer to publish an NPRM with a 30-day Executive Order 13771 directs agencies Jennifer Haggins, Marine Safety Unit comment period because we must to control regulatory costs through a Pittsburgh, U.S. Coast Guard; telephone establish this special local regulation by budgeting process. This NPRM has not 412–221–0807, email June 29, 2018. A 15-day comment been designated a ‘‘significant [email protected]. period would allow the Coast Guard to provide for public notice and comment, regulatory action,’’ under Executive SUPPLEMENTARY INFORMATION: but also publish a rule, if adopted, soon Order 12866. Accordingly, the NPRM I. Table of Abbreviations enough that the length of the notice and has not been reviewed by the Office of comment period does not compromise Management and Budget (OMB), and CFR Code of Federal Regulations public safety. pursuant to OMB guidance it is exempt COTP Captain of the Port Marine Safety from the requirements of Executive Unit Pittsburgh III. Discussion of Proposed Rule DHS Department of Homeland Security Order 13771. FR Federal Register The COTP proposes to establish a This regulatory action determination NPRM Notice of proposed rulemaking special local regulation for all navigable is based on the size and location of the § Section waters of the Allegheny, Monongahela, special local regulation. The special U.S.C. United States Code and Ohio Rivers between the Ninth local regulation will impact a small Street Highway Bridge at mile marker section of the Allegheny, Monongahela, II. Background, Purpose, and Legal (MM) 0.8, Allegheny River, Fort Pitt Basis and Ohio Rivers, less than three total Highway Bridge at MM 0.22, miles. Moreover, the special local Heinz Field notified the Coast Guard Monongahela River, and West End- regulation will not stop vessels from that it would be holding a concert from North Side Highway Bridge at MM 0.8, transiting the area, it will only establish 4 p.m. to 11 p.m. on June 30, 2018. Ohio River. The duration of the special certain areas where vessels are Heinz Field is located in close local regulation is intended to ensure prohibited from loitering, anchoring, proximity to the banks of the Ohio and the safety of vessels on these navigable stopping, remaining, or drifting because Allegheny Rivers, which is a high vessel waters before, during, and after the it impedes navigation near launching traffic area used by both commercial concert weekend. This proposed rule ramps, marinas, and fleeting areas, or and recreational vessels. Due to the would apply to any vessel operating commercial traffic in the rivers. proximity of Heinz Field to these within the area, including a naval or Moreover, the Coast Guard would issue waterways, it will be a destination for public vessel, except a vessel engaged in Broadcast Notice to Mariners (BNMs) many recreational vessels to anchor and law enforcement, servicing aids to via VHF–FM marine channel 16 about loiter throughout the concert weekend navigation, or surveying, maintaining, the regulated area and the rule would of June 29, 2018 to July 1, 2018. The or improving waters within the allow vessels to seek permission to enter Coast Guard is concerned about possible regulated area. No vessel would be the regulated area. collisions that could occur in this area permitted to loiter, anchor, stop, moor, and the impact of vessel congestion on remain or drift in any manner that B. Impact on Small Entities maritime commerce due to transit impedes safe passage of another vessel The Regulatory Flexibility Act of delays. The Captain of the Port Marine to any launching ramp, marina, or 1980, 5 U.S.C. 601–612, as amended, Safety Unit Pittsburgh (COTP) has fleeting area unless authorized by the requires Federal agencies to consider

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the potential impact of regulations on Order 13175, Consultation and person listed in the FOR FURTHER small entities during rulemaking. The Coordination with Indian Tribal INFORMATION CONTACT section to term ‘‘small entities’’ comprises small Governments, because it would not have coordinate protest activities so that your businesses, not-for-profit organizations a substantial direct effect on one or message can be received without that are independently owned and more Indian tribes, on the relationship jeopardizing the safety or security of operated and are not dominant in their between the Federal Government and people, places, or vessels. fields, and governmental jurisdictions Indian tribes, or on the distribution of with populations of less than 50,000. power and responsibilities between the V. Public Participation and Request for The Coast Guard certifies under 5 U.S.C. Federal Government and Indian tribes. Comments 605(b) that this proposed rule would not If you believe this proposed rule has We view public participation as have a significant economic impact on implications for federalism or Indian essential to effective rulemaking, and a substantial number of small entities. tribes, please contact the person listed will consider all comments and material While some owners or operators of in the FOR FURTHER INFORMATION received during the comment period. vessels intending to transit the regulated CONTACT section. Your comment can help shape the area may be small entities, for the E. Unfunded Mandates Reform Act outcome of this rulemaking. If you reasons stated in section IV.A above, submit a comment, please include the The Unfunded Mandates Reform Act this proposed rule would not have a docket number for this rulemaking, of 1995 (2 U.S.C. 1531–1538) requires significant economic impact on any indicate the specific section of this Federal agencies to assess the effects of vessel owner or operator. document to which each comment their discretionary regulatory actions. In If you think that your business, applies, and provide a reason for each particular, the Act addresses actions organization, or governmental suggestion or recommendation. jurisdiction qualifies as a small entity that may result in the expenditure by a and that this rule would have a State, local, or tribal government, in the We encourage you to submit significant economic impact on it, aggregate, or by the private sector of comments through the Federal please submit a comment (see $100,000,000 (adjusted for inflation) or eRulemaking Portal at http:// ADDRESSES) explaining why you think it more in any one year. Though this www.regulations.gov. If your material qualifies and how and to what degree proposed rule would not result in such cannot be submitted using http:// this rule would economically affect it. an expenditure, we do discuss the www.regulations.gov, contact the person Under section 213(a) of the Small effects of this rule elsewhere in this in the FOR FURTHER INFORMATION Business Regulatory Enforcement preamble. CONTACT section of this document for alternate instructions. Fairness Act of 1996 (Pub. L. 104–121), F. Environment we want to assist small entities in We accept anonymous comments. All understanding this proposed rule. If the We have analyzed this proposed rule comments received will be posted rule would affect your small business, under Department of Homeland without change to http:// organization, or governmental Security Management Directive 023–01 www.regulations.gov and will include jurisdiction and you have questions and Commandant Instruction any personal information you have concerning its provisions or options for M16475.lD, which guide the Coast provided. For more about privacy and compliance, please contact the person Guard in complying with the National the docket, visit http:// listed in the FOR FURTHER INFORMATION Environmental Policy Act of 1969 (42 www.regulations.gov/privacyNotice. CONTACT section. The Coast Guard will U.S.C. 4321–4370f), and have made a preliminary determination that this Documents mentioned in this NPRM not retaliate against small entities that as being available in the docket, and all question or complain about this action is one of a category of actions that do not individually or cumulatively public comments, will be in our online proposed rule or any policy or action of docket at http://www.regulations.gov the Coast Guard. have a significant effect on the human environment. This proposed rule and can be viewed by following that C. Collection of Information involves a special local regulation that website’s instructions. Additionally, if you go to the online docket and sign up This proposed rule would not call for prohibits vessels from loitering, for email alerts, you will be notified a new collection of information under anchoring, stopping, remaining or when comments are posted or a final the Paperwork Reduction Act of 1995 drifting more than 100 feet from any rule is published. (44 U.S.C. 3501–3520). bank. Normally such actions are categorically excluded from further List of Subjects in 33 CFR Part 100 D. Federalism and Indian Tribal review under paragraph L61 of Governments Appendix A, Table 1 of Implementation Marine safety, Navigation (water), A rule has implications for federalism of the National Environmental Policy Reporting and recordkeeping under Executive Order 13132, Act, Department of Homeland Security requirements, Security measures, Federalism, if it has a substantial direct Instruction Manual 023–01–001–01. A Waterways. effect on the States, on the relationship preliminary environmental analysis For the reasons discussed in the between the national government and checklist and Categorical Exclusion preamble, the Coast Guard proposes to the States, or on the distribution of Determination are available in the amend 33 CFR part 100 as follows: power and responsibilities among the docket where indicated under various levels of government. We have ADDRESSES. We seek any comments or PART 100—SAFETY OF LIFE ON analyzed this proposed rule under that information that may lead to the NAVIGABLE WATERS Order and have determined that it is discovery of a significant environmental consistent with the fundamental impact from this proposed rule. ■ 1. The authority citation for part 100 federalism principles and preemption continues to read as follows: requirements described in Executive G. Protest Activities Authority: 33 U.S.C. 1233. Order 13132. The Coast Guard respects the First Also, this proposed rule does not have Amendment rights of protesters. ■ 2. Add § 100.T08–0320 to read as tribal implications under Executive Protesters are asked to contact the follows:

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§ 100.T08–0320 Special Local Regulation; DEPARTMENT OF HOMELAND II. Background, Purpose, and Legal Monongahela River (MM 0.22), Allegheny SECURITY Basis River (MM 0.8), and Ohio River (MM 0.8), The Captain of the Port Sector Upper Pittsburgh, PA. Coast Guard Mississippi River (COTP) proposes to (a) Location. The following is a amend 33 CFR 165.801 to update the special local regulation for all navigable 33 CFR Part 165 table of annual fireworks displays and waters of the Allegheny, Monongahela, other marine-related events in Coast and Ohio Rivers between the Ninth [Docket Number USCG–2018–0038] Guard Sector Upper Mississippi River. Street Highway Bridge at mile marker The current list of annual and recurring (MM) 0.8, Allegheny River, Fort Pitt RIN 1625–AA00 safety zones in Sector Upper Mississippi Highway Bridge at MM 0.22, Safety Zones; Coast Guard Sector River is published in Table 2 of 33 CFR Monongahela River, and West End- Upper Mississippi River Annual and 165.801. That most recent table was North Side Highway Bridge at MM 0.8, Recurring Safety Zones Update created through the final rule published Ohio River. on June 21, 2017 (82 FR 28235). The AGENCY: Coast Guard, DHS. (b) Applicability. This section applies current table in 33 CFR 165.801 needs to any vessel operating within the area, ACTION: Notice of proposed rulemaking. to be amended to include new safety including a naval or public vessel, zones expected to recur annually or except a vessel engaged in: SUMMARY: The Coast Guard proposes to amend its safety zone regulations for biannually, remove safety zones no (1) Law enforcement; longer recurring, and provide new (2) Servicing aids to navigation; or annual events in Coast Guard Sector Upper Mississippi River. This proposed information on existing safety zones. (3) Surveying, maintaining, or The proposed annually recurring rule would add one new recurring safety improving waters within the regulated safety zones are necessary to provide for zone, remove four safety zones, and area. the safety of life on navigable waters amend the sponsor/name, date, and/or (c) Regulations. (1) In accordance with during the events. Based on the nature safety zones for three recurring safety the general regulations in § 100.801 of of these marine events, large numbers of zones already listed in the current table. this part, no vessel shall loiter, anchor, participants and spectators, and event This action is necessary to protect stop, moor, remain or drift in any locations, the COTP has determined that spectators, participants, and vessels manner as to impede safe passage of the events listed in this proposed rule from the hazards associated with annual another vessel to any launching ramp, could pose a risk to participants or marine events. This proposed marina, or fleeting area unless waterways users if the normal vessel rulemaking would restrict vessel traffic authorized by the Captain of the Port traffic were to interfere with the events. from the safety zones during the events Marine Safety Unit Pittsburgh (COTP) or Possible hazards include risks of injury unless authorized by the Captain of the a designated representative. They may or death from near or actual contact Port Sector Upper Mississippi River or be contacted on VHF–FM Channel 16. among participant vessels and a designated representative. We invite spectators or mariners traversing (2) No vessel shall loiter, anchor, stop, your comments on this proposed through the safety zone. In order to moor, remain or drift at any time more rulemaking. than 100 feet from any river bank within protect the safety of all waterway users, the regulated area unless authorized by DATES: Comments and related material including event participants and the COTP or a designated must be received by the Coast Guard on spectators, this proposed rule would representative. or before May 17, 2018. establish safety zones for the time and (3) Persons and vessels permitted to ADDRESSES: You may submit comments location of each marine event. enter this regulated area must transit at identified by docket number USCG– This purpose of this proposed their slowest safe speed and comply 2018–0038 using the Federal rulemaking is to ensure the safety of with all lawful directions issued by the eRulemaking Portal at http:// vessels on the navigable waters in the COTP or the designated representative. www.regulations.gov. See the ‘‘Public safety zones during the scheduled (4) Persons and vessels permitted to Participation and Request for events. Vessels would not be permitted enter this regulated area must transit at Comments’’ portion of the to enter the safety zone unless their slowest safe speed and comply SUPPLEMENTARY INFORMATION section for authorized by the COTP or a designated with all lawful directions issued by the further instructions on submitting representative. The Coast Guard COTP or the designated representative. comments. proposes this rulemaking under authority in 33 U.S.C. 1231. (d) Effective period. This section will FOR FURTHER INFORMATION CONTACT: If be effective from 4 p.m. on June 29, you have questions on this proposed III. Discussion of Proposed Rule 2018 through noon on July 1, 2018. rule, call or email Lieutenant The COTP proposes to amend its (e) Informational broadcasts. The Commander Sean Peterson, Chief of safety zone regulations for annual COTP or a designated representative Prevention, U.S. Coast Guard; telephone events in Coast Guard Sector Upper will inform the public through (314) 269–2568, email Mississippi River listed in Table 2 of 33 Broadcast Notices to Mariners (BNMs) Sean.M.Peterson@uscg,mil. CFR 165.801. This section requires of the enforcement period for the SUPPLEMENTARY INFORMATION: amendment from time to time to regulated area as well as any changes in properly reflect the recurring safety the dates and times of enforcement. I. Table of Abbreviations zone regulations in Sector Upper Dated: April 12, 2018. CFR Code of Federal Regulations Mississippi River. This rule would add F.M. Smith, COTP Captain of the Port Sector Upper one new recurring safety zone, remove Mississippi River Lieutenant Commander, U.S. Coast Guard, DHS Department of Homeland Security four no longer recurring safety zones, Captain of the Port Marine Safety Unit FR Federal Register and amend the sponsor/name, date, Pittsburgh, Acting. NPRM Notice of proposed rulemaking and/or safety zones for three recurring [FR Doc. 2018–08032 Filed 4–16–18; 8:45 am] § Section safety zones already listed in the current BILLING CODE 9110–04–P U.S.C. United States Code table. Other than this one new safety

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zone, four removed safety zones, and 3 other provisions in Table 2 of § 165.801 by adding one new safety zone. The changes to the sponsor/name, date, and/ would remain unchanged. safety zone being added to Table 2 is or safety zones of certain events, the The Coast Guard proposes to revise below: regulations of 33 CFR 165.801 and the regulations at 33 CFR 165.801 Table 2

Sector Upper Date Sponsor/name Mississippi Safety zone River location

2 days—3rd Weekend in Kentucky Drag Boat Association/Evans- Evansville, IL ...... Kaskaskia River mile marker 9 to 11. July. ville, IL Drag Boat Races.

The Coast Guard also proposes to existing safety zones that are no longer 165.801. The four existing safety zones revise regulations at 33 CFR 165.801 recurring, with reference by line number being removed are below: Table 2 by removing the following four to the current Table 2 of 33 CFR

Sector Upper Line Date Sponsor/name Mississippi Safety zone River location

3 ...... 1 day—2nd Weekend of City of Champlin/Father Hennepin Champlin, MN ...... Upper Mississippi River mile marker June. Fireworks Display. 870.5 to 872.0. 22 ...... 1 day—3rd Sunday in Burlington Steamboat Days/Burlington Burlington, IA ...... Upper Mississippi River mile marker June. Steamboat Days. 403.5 to 404.5. 34 ...... 1 day—4th of July Week- McGregor/Marquette Chamber Com- Marquette, IA ...... Upper Mississippi River mile marker end. merce/Independence Day Celebra- 635.7 to 634.2. tion. 37 ...... 2 days—3rd Weekend of Riverside Chamber of Commerce/ Riverside, MO ...... Missouri River mile marker 371.8 to September. Riverfest. 372.2.

The Coast Guard also proposes to marine event sponsor/name and/or This proposed rule modifies the revise regulations at 33 CFR 165.801 safety zones, with reference by line following three safety zones from the Table 2 by amending three existing number to the current Table 2 of 33 CFR existing Table 2 in § 165.801 as follows: safety zones listed in the current table. 165.801. The three safety zones being The amendments involve changes to amended are below:

Sector Upper Line Date Sponsor/name Mississippi Safety zone Revision River location

1 ...... 1 day—4th Week- Marketing Minneapolis LLC/ Minneapolis, MN ... Upper Mississippi River mile Sponsor/name. end in July. Aquatennial Fireworks. marker 853.2 to 854.2. 32 ...... 1 day—4th of July Grafton Chamber of Com- Grafton, IL ...... Upper Mississippi River mile Safety zone. Weekend. merce/Grafton Chamber marker 218 to 219. 4th of July Fireworks. 41 ...... 1 day—4th of July City of East Moline/City of East Moline, IL ...... Upper Mississippi River mile Date and safety zone. Week. East Moline Fireworks. marker 489.9 to 490.2.

The amendments to this rule are IV. Regulatory Analyses This NPRM has not been designated necessary to ensure the safety of vessels a ‘‘significant regulatory action,’’ under and people during annual events taking We developed this proposed rule after Executive Order 12866. Accordingly, place on or near navigable waters in considering numerous statutes and the NPRM has not been reviewed by the Sector Upper Mississippi River. Executive orders related to rulemaking. Office of Management and Budget Although this proposed rule would be Below we summarize our analyses (OMB), and pursuant to OMB guidance based on a number of these statutes and in effect year-round, the specific safety it is exempt from the requirements of Executive orders and we discuss First zones listed in Table 2 of 33 CFR Executive Order 13771. Amendment rights of protestors. 165.801 would only be enforced during This regulatory action determination a specified period of time coinciding A. Regulatory Planning and Review is based on the size, location, and with the happening of the annual events duration of the safety zones. These listed. In accordance with the Executive Orders 12866 and 13563 direct agencies to assess the costs and safety zones are limited in size and regulations listed in 33 CFR 165.801(a)– duration, and are usually positioned (d), entry into these safety zones is benefits of available regulatory alternatives and, if regulation is away from high vessel traffic zones. prohibited unless authorized by the necessary, to select regulatory Moreover, the Coast Guard would issue COTP or a designated representative. approaches that maximize net benefits. a Broadcast Notice to Mariners via The regulatory text of the updated Table Executive Order 13771 directs agencies VHF–FM marine channel 16 about the 2 of § 165.801 we are proposing appears to control regulatory costs through a zones, and the rule would allow vessels at the end of this document. budgeting process. to seek permission to enter the zones.

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B. Impact on Small Entities federalism principles and preemption G. Protest Activities The Regulatory Flexibility Act of requirements described in Executive The Coast Guard respects the First 1980, 5 U.S.C. 601–612, as amended, Order 13132. Amendment rights of protesters. requires Federal agencies to consider Also, this proposed rule does not have Protesters are asked to contact the the potential impact of regulations on tribal implications under Executive person listed in the FOR FURTHER small entities during rulemaking. The Order 13175, Consultation and INFORMATION CONTACT section to term ‘‘small entities’’ comprises small Coordination with Indian Tribal coordinate protest activities so that your businesses, not-for-profit organizations Governments, because it would not have message can be received without that are independently owned and a substantial direct effect on one or jeopardizing the safety or security of operated and are not dominant in their more Indian tribes, on the relationship people, places, or vessels. fields, and governmental jurisdictions between the Federal Government and V. Public Participation and Request for with populations of less than 50,000. Indian tribes, or on the distribution of Comments The Coast Guard certifies under 5 U.S.C. power and responsibilities between the 605(b) that this proposed rule would not Federal Government and Indian tribes. We view public participation as have a significant economic impact on If you believe this proposed rule has essential to effective rulemaking, and a substantial number of small entities. implications for federalism or Indian will consider all comments and material While some owners or operators of tribes, please contact the person listed received during the comment period. Your comment can help shape the vessels intending to transit the safety in the FOR FURTHER INFORMATION outcome of this rulemaking. If you zone may be small entities, for the CONTACT section. reasons stated in section IV.A above, submit a comment, please include the this proposed rule would not have a E. Unfunded Mandates Reform Act docket number for this rulemaking, significant economic impact on any indicate the specific section of this vessel owner or operator. The Unfunded Mandates Reform Act document to which each comment If you think that your business, of 1995 (2 U.S.C. 1531–1538) requires applies, and provide a reason for each organization, or governmental Federal agencies to assess the effects of suggestion or recommendation. jurisdiction qualifies as a small entity their discretionary regulatory actions. In We encourage you to submit and that this rule would have a particular, the Act addresses actions comments through the Federal significant economic impact on it, that may result in the expenditure by a eRulemaking Portal at http:// please submit a comment (see State, local, or tribal government, in the www.regulations.gov. If your material ADDRESSES) explaining why you think it aggregate, or by the private sector of cannot be submitted using http:// qualifies and how and to what degree $100,000,000 (adjusted for inflation) or www.regulations.gov, contact the person this rule would economically affect it. more in any one year. Though this in the FOR FURTHER INFORMATION Under section 213(a) of the Small proposed rule would not result in such CONTACT section of this document for Business Regulatory Enforcement an expenditure, we do discuss the alternate instructions. Fairness Act of 1996 (Pub. L. 104–121), effects of this rule elsewhere in this We accept anonymous comments. All we want to assist small entities in preamble. comments received will be posted understanding this proposed rule. If the without change to http:// F. Environment rule would affect your small business, www.regulations.gov and will include organization, or governmental We have analyzed this proposed rule any personal information you have jurisdiction and you have questions under Department of Homeland provided. For more about privacy and concerning its provisions or options for Security Directive 023–01 and the docket, visit http:// compliance, please contact the person Commandant Instruction M16475.lD, www.regulations.gov/privacyNotice. listed in the FOR FURTHER INFORMATION which guide the Coast Guard in Documents mentioned in this NPRM CONTACT section. The Coast Guard will complying with the National as being available in the docket, and all not retaliate against small entities that Environmental Policy Act of 1969 (42 public comments, will be in our online question or complain about this U.S.C. 4321–4370f), and have made a docket at http://www.regulations.gov proposed rule or any policy or action of preliminary determination that this and can be viewed by following that the Coast Guard. action is one of a category of actions that website’s instructions. Additionally, if you go to the online docket and sign up C. Collection of Information do not individually or cumulatively for email alerts, you will be notified have a significant effect on the human This proposed rule would not call for when comments are posted or a final environment. This proposed rule a new collection of information under rule is published. the Paperwork Reduction Act of 1995 involves establishing safety zones (44 U.S.C. 3501–3520). limiting access to certain areas under 33 List of Subjects in 33 CFR Part 165 CFR 165 within the COTP Zone. Harbors, Marine safety, Navigation D. Federalism and Indian Tribal Normally such actions are categorically (water), Reporting and recordkeeping Governments excluded from further review under requirements, Security measures, A rule has implications for federalism paragraph L60(a) of Appendix A, Table Waterways. under Executive Order 13132, 1 of DHS Instruction Manual 023–01– 001–01, Rev. 01. A Record of For the reasons discussed in the Federalism, if it has a substantial direct preamble, the U.S. Coast Guard Environmental Consideration effect on the States, on the relationship proposes to amend 33 CFR part 165 as supporting this determination is between the national government and follows: the States, or on the distribution of available in the docket where indicated power and responsibilities among the under ADDRESSES. We seek any PART 165—REGULATED NAVIGATION various levels of government. We have comments or information that may lead AREAS AND LIMITED ACCESS AREAS analyzed this proposed rule under that to the discovery of a significant Order and have determined that it is environmental impact from this ■ 1. The authority citation for part 165 consistent with the fundamental proposed rule. continues to read as follows:

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Authority: 33 U.S.C. 1231; 50 U.S.C. 191; Department of Homeland Security Delegation § 165.801 [Amended] 33 CFR 1.05–1, 6.04–1, 6.04–6, and 160.5; No. 0170.1. ■ 2. In § 165.801, revise Table 2 to read as follows:

TABLE 2 OF § 165.801—SECTOR UPPER MISSISSIPPI RIVER ANNUAL AND RECURRING SAFETY ZONES

Sector Upper Date Sponsor/name Mississippi Safety zone River location

1. 1 day—4th Weekend in Marketing Minneapolis LLC/Aquatennial Minneapolis, MN...... Upper Mississippi River mile marker July. Fireworks. 853.2 to 854.2. 2. 1 day—4th of July week- Radio Dubuque/Radio Dubuque Fire- Dubuque, IA...... Upper Mississippi River mile marker end. works and Air show. 581.0 to 583.0. 3. 1 day—4th of July week- Downtown Main Street/Mississippi Red Wing, MN...... Upper Mississippi River mile marker end. Alumination. 790.8 to 791.2. 4. 1 day—4th of July week- Tan-Tar-A Resort/Tan-Tar-A 4th of July Lake of the Ozarks, MO .... Lake of the Ozarks mile marker 025.8 to end. Fireworks. 026.2. 5. 1 day—1st weekend of Tan-Tar-A Resort/Tan-Tar-A Labor Day Lake of the Ozarks, MO .... Lake of the Ozarks mile marker 025.8 to September. Fireworks. 026.2. 6. 1 day—Last Sunday in Tan-Tar-A Resort/Tan-Tar-A Memorial Lake of the Ozarks, MO .... Lake of the Ozarks mile marker 025.8 to May. Day fireworks. 026.2. 7. 1 day—4th of July week- Lake City Chamber of Commerce/Lake Lake City, MN...... Upper Mississippi River mile marker end. City 4th of July Fireworks. 772.4 to 772.8. 8. 1 day—4th of July week- Greater Muscatine Chamber of Com- Muscatine, IA...... Upper Mississippi River mile marker end. merce/Muscatine 4th of July. 455.0 to 456.0. 9. 1 day—Last weekend in Friends of the River Kansas City/KC Kansas City, KS...... Missouri River mile marker 364.8 to June/First weekend in Riverfest. 365.2. July. 10. 1 day—4th of July week- Louisiana Chamber of Commerce/Lou- Louisiana, MO...... Upper Mississippi River mile marker end. isiana July 4th Fireworks. 282.0 to 283.0. 11. 1 day—4th of July week- Guttenberg Development and Tourism/ Guttenberg, IA...... Upper Mississippi River mile marker end. Stars and Stripes River Day. 615.0 to 615.5. 12. 4 days—1st or 2nd Riverfest, Inc./La Crosse Riverfest ...... La Crosse, WI ...... Upper Mississippi River mile marker week of July. 697.5 to 698.5 (Wisconsin). 13. 1 day—2nd weekend in Prairie du Chien Area Chamber of Com- Prairie du Chien, WI...... Upper Mississippi River mile marker July. merce/Prairie du Chien Area Chamber 635.2 to 635.7. Fireworks. 14. 1 day—4th of July week- JMP Radio/Red White and Boom Peoria Peoria, IL ...... Illinois River mile marker 162.5 to 162.1. end. 15. 1 day—Last weekend in Hudson Boosters/Hudson Booster Days Hudson, WI...... St. Croix River mile marker 016.8 to June/First weekend in 017.2. July. 16. 2 days—4th of July City of St. Charles/St. Charles Riverfest St. Charles, MO ...... Missouri River mile marker 028.2 to weekend. 028.8. 17. 1 day—4th of July week- Minneapolis Park and Recreation Board/ Minneapolis, MN...... Upper Mississippi River mile marker end. Red, White, and Boom Minneapolis. 853.5 to 854.5. 18. 1 day—4th of July week- Davenport One Chamber/Red White and Davenport, IA...... Upper Mississippi River mile marker end. Boom. 482.0 to 482.7. 19. 2 days—3rd weekend of Amelia Earhart Festival Committee/ Kansas City, KS...... Missouri River mile marker 422.0 to July. Amelia Earhart Festival. 424.5. 20. 1 day—4th of July week- Alton Exposition Commission/Mississippi Alton, IL...... Upper Mississippi River mile marker end. Fireworks Festival. 202.5 to 203.0. 21. 1 day—Last Sunday in Lodge of the Four Seasons/Lodge of the Lake of the Ozarks, MO .... Lake of the Ozarks mile marker 013.8 to May. Four Seasons Memorial Day Fire- 014.2. works. 22. 1 day—First weekend of Lodge of the Four Seasons/Labor Day Lake of the Ozarks, MO .... Lake of the Ozarks mile marker 013.8 to September. Fireworks. 014.2. 23. 1 day—4th of July week- Lodge of the Four Seasons/Lodge of the Lake of the Ozarks, MO .... Lake of the Ozarks mile marker 013.8 to end. Four Seasons 4th of July. 014.2. 24. 2 days—3rd weekend in Hasting Riverboat Days/Rivertown Days Hasting, MN ...... Upper Mississippi River mile marker July. 813.7 to 815.2. 25. 1 day—Sunday of Fa- Winona Steamboat Days/Winona Steam- Winona, MN...... Upper Mississippi River mile marker ther’s Day weekend. boat Days Fireworks. 725.4 to 725.7. 26. 3 days—4th of July Fair of St. Louis/Fair St. Louis ...... St. Louis, MO ...... Upper Mississippi River mile marker weekend. 179.2 to 180.0. 27. 1 day—Last weekend in Bellevue Heritage Days/Bellevue Herit- Bellevue, IA...... Upper Mississippi River mile marker June/First weekend in age Days. 556.0 to 556.5. July. 28. 1 day—4th of July week- Main Street Parkway Association/Park- Parkville, MO...... Missouri River mile marker 378.0 to end. ville 4th of July Fireworks. 377.5. 29. 1 day—4th of July week- Hermann Chamber of Commerce/Her- Hermann, MO...... Missouri River mile marker 097.0 to end. mann 4th of July. 098.0 (Missouri). 30. 1 day—4th of July week- Grafton Chamber of Commerce/Grafton Grafton, IL ...... Upper Mississippi River mile marker 218 end. Chamber 4th of July Fireworks. to 219.

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TABLE 2 OF § 165.801—SECTOR UPPER MISSISSIPPI RIVER ANNUAL AND RECURRING SAFETY ZONES—Continued

Sector Upper Date Sponsor/name Mississippi Safety zone River location

31. 1 day—4th of July week- Salute to America Foundation, Inc./Sa- Jefferson City, MO ...... Missouri River mile marker 143.5 to end. lute to America. 143.0 (Missouri). 32. 2 days—2nd weekend in Tug Committee/Great River Tug ...... Port Byron, IL ...... Upper Mississippi River mile marker August. 497.2 to 497.6 (Illinois). 33. 1 day—4th of July week- City of Stillwater/St. Croix Events/Still- Stillwater, MN ...... St. Croix River mile marker 022.9 to end. water 4th of July. 023.5 (Minnesota). 34. 4 days—3rd week of St. Croix Events/Lumberjack Days ...... Stillwater, MN ...... St. Croix River mile marker 022.9 to July. 023.5 (Minnesota). 35. 2 days—Weekend that Lake of the Ozarks Shootout, Inc./Lake Lake of the Ozarks, MO .... Lake of the Ozarks mile marker 032.5 to precedes Labor Day of the Ozarks Shootout. 034.5. Weekend. 36. 2 days—1st weekend of City of Keithsburg/Keithsburg Fireworks Keithsburg, IL...... Upper Mississippi River mile marker September. Display. 427.5 to 427.3. 37. 1 day—4th of July Week City of East Moline/City of East Moline East Moline, IL...... Upper Mississippi River mile marker Fireworks. 489.9 to 490.2. 38. 2nd Weekend in August Lansing Lion’s Club/Lansing Fish Days Lansing, IA...... Upper Mississippi River mile marker Fireworks. 662.8–663.9. 39. 3rd Weekend in August River Action/Floatzilla ...... Rock Island, Illinois ...... Upper Mississippi River mile marker 479.0–486.0. 40. 1 day—Weekend before Main Street Parkway Association/Park- Parkville, MO...... Missouri River mile marker 377.5 to Thanksgiving. ville Christmas on the River. 378.0. 41. 1 day—4th of July week- City of Marquette/Marquette Independ- Marquette, IA...... Upper Mississippi River mile marker end. ence Day Celebration. 634.2 to 635.7. 42. 1 day—1st Weekend in St. Louis Brewers Guild Festival Fire- St. Louis, MO...... Upper Mississippi River mile marker June. works. 179.2–180 43. 1 day—4th Weekend in Lumiere Place/Memorial Day Fireworks St. Louis, MO ...... Upper Mississippi River mile marker May. 180–180.5 44. 1 day—1st Weekend in Lumiere Place/4th of July Fireworks ...... St. Louis, MO ...... Upper Mississippi River mile marker July. 180–180.5 45. 1 day—1st Weekend in Lumiere Place/Labor Day Fireworks ...... St. Louis, MO ...... Upper Mississippi River mile marker September. 180–180.5 46. 2 days—3rd Weekend in Kentucky Drag Boat Association/Evans- Evansville, IL ...... Kaskaskia River mile marker 9 to 11. July. ville, IL Drag Boat Races.

Dated: April 11, 2018. rulemaking would prohibit persons and COTP Captain of the Port Sector New Scott A. Stoermer, vessels from being in the safety zone Orleans DHS Department of Homeland Security Captain, U.S. Coast Guard, Captain of the unless authorized by the Captain of the FR Federal Register Port Sector Upper Mississippi River. Port Sector New Orleans or a designated NPRM Notice of proposed rulemaking [FR Doc. 2018–08013 Filed 4–16–18; 8:45 am] representative. We invite your § Section BILLING CODE 9110–04–P comments on this proposed rulemaking. U.S.C. United States Code DATES: Comments and related material II. Background, Purpose, and Legal must be received by the Coast Guard on DEPARTMENT OF HOMELAND Basis or before May 17, 2018. SECURITY On April 4, 2018, Geaux Pyro notified ADDRESSES: You may submit comments the Coast Guard that it would conduct Coast Guard identified by docket number USCG– a fireworks display from 7 p.m. through 2018–0332 using the Federal 7:20 p.m. on July 4, 2018, for a wedding 33 CFR Part 165 eRulemaking Portal at http:// celebration. The fireworks are to be [Docket Number USCG–2018–0332] www.regulations.gov. See the ‘‘Public launched from a barge on the Participation and Request for Tchefuncte River, at approximate RIN 1625–AA00 Comments’’ portion of the position 30°24′11.63″ N 090°09′17.39″ SUPPLEMENTARY INFORMATION section for W, in front of the Madisonville Town Safety Zone; Lower Tchefuncte River, further instructions on submitting Hall. Hazards from firework displays Madisonville, LA comments. include accidental discharge of AGENCY: Coast Guard, DHS. fireworks, dangerous projectiles, and FOR FURTHER INFORMATION CONTACT: If ACTION: Notice of proposed rulemaking. falling hot embers or other debris. The you have questions on this rule, call or Captain of the Port Sector New Orleans SUMMARY: The Coast Guard proposes to email Lieutenant Commander Howard (COTP) has determined that potential establish a temporary safety zone for Vacco, Sector New Orleans, U.S. Coast hazards associated with the fireworks to certain navigable waters of the Guard; telephone 504–365–2281, email be used in this display would be a safety Tchefuncte River. This action is [email protected]. concern for anyone within 100 yards of necessary to provide for the safety of life SUPPLEMENTARY INFORMATION: the launch barge. on these navigable waters near The purpose of this rulemaking is to Madisonville, LA, during a fireworks I. Table of Abbreviations ensure the safety of vessels and the display on July 4, 2018. This proposed CFR Code of Federal Regulations navigable waters within a 100-yard

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radius of the launch barge before, from the requirements of Executive D. Federalism and Indian Tribal during, and after the fireworks display. Order 13771. Governments The Coast Guard proposes this This regulatory action determination A rule has implications for federalism rulemaking under authority in 33 U.S.C. is based on the size and duration of the under Executive Order 13132, 1231. safety zone. This proposed safety zone Federalism, if it has a substantial direct III. Discussion of Proposed Rule would only encompass a 100-yard effect on the States, on the relationship radius of the Tchefuncte River for one between the national government and The COTP proposes to establish a hour on one evening. Moreover, the the States, or on the distribution of safety zone from 6:45 p.m. through 7:45 Coast Guard would issue a Broadcast power and responsibilities among the p.m. on July 4, 2018. The safety zone Notice to Mariners via VHF–FM marine various levels of government. We have would cover all navigable waters of the channel 16 about the zone, and the analyzed this proposed rule under that Tchefuncte River within 100-yards of a proposed rule would allow vessels to Order and have determined that it is barge at approximate position seek permission to enter the zone. consistent with the fundamental 30°24′11.63″ N 090°09′17.39″ W, in B. Impact on Small Entities federalism principles and preemption front of the Madisonville Town Hall in requirements described in Executive Madisonville, LA. The duration of the The Regulatory Flexibility Act of Order 13132. zone is intended to ensure the safety of 1980, 5 U.S.C. 601–612, as amended, Also, this proposed rule does not have vessels and these navigable waters requires Federal agencies to consider tribal implications under Executive before, during, and after the scheduled the potential impact of regulations on Order 13175, Consultation and 7 p.m. to 7:20 p.m. fireworks display. small entities during rulemaking. The Coordination with Indian Tribal No vessel or person would be permitted term ‘‘small entities’’ comprises small Governments, because it would not have to enter the safety zone without businesses, not-for-profit organizations a substantial direct effect on one or obtaining permission from the COTP or that are independently owned and more Indian tribes, on the relationship a designated representative. A operated and are not dominant in their between the Federal Government and designated representative is a fields, and governmental jurisdictions Indian tribes, or on the distribution of commissioned, warrant, or petty officer with populations of less than 50,000. power and responsibilities between the of the U.S. Coast Guard assigned to The Coast Guard certifies under 5 U.S.C. Federal Government and Indian tribes. units under the operational control of 605(b) that this proposed rule would not If you believe this proposed rule has USCG Sector New Orleans. have a significant economic impact on implications for federalism or Indian Vessels requiring entry into this safety a substantial number of small entities. tribes, please contact the person listed zone must request permission from the While some owners or operators of in the FOR FURTHER INFORMATION COTP or a designated representative. vessels intending to transit the safety CONTACT section. They may be contacted on VHF–FM zone may be small entities, for the Channel 16 or 67 or by telephone at reasons stated in section IV.A above, E. Unfunded Mandates Reform Act (504) 365–2200. Persons and vessels this proposed rule would not have a The Unfunded Mandates Reform Act permitted to enter this safety zone must significant economic impact on any of 1995 (2 U.S.C. 1531–1538) requires transit at their slowest safe speed and vessel owner or operator. Federal agencies to assess the effects of comply with all lawful directions issued If you think that your business, their discretionary regulatory actions. In by the COTP or the designated organization, or governmental particular, the Act addresses actions representative. The regulatory text we jurisdiction qualifies as a small entity that may result in the expenditure by a are proposing appears at the end of this and that this rulemaking would have a State, local, or tribal government, in the document. significant economic impact on it, aggregate, or by the private sector of please submit a comment (see IV. Regulatory Analyses $100,000,000 (adjusted for inflation) or ADDRESSES) explaining why you think it more in any one year. Though this We developed this proposed rule after qualifies and how and to what degree proposed rule would not result in such considering numerous statutes and this rule would economically affect it. an expenditure, we do discuss the Executive orders related to rulemaking. Under section 213(a) of the Small effects of this rule elsewhere in this Below we summarize our analyses Business Regulatory Enforcement preamble. based on a number of these statutes and Fairness Act of 1996 (Pub. L. 104–121), Executive orders and we discuss First we want to assist small entities in F. Environment Amendment rights of protestors. understanding this proposed rule. If the We have analyzed this proposed rule under Department of Homeland A. Regulatory Planning and Review rulemaking would affect your small business, organization, or governmental Security Directive 023–01 and Executive Orders 12866 and 13563 jurisdiction and you have questions Commandant Instruction M16475.1D, direct agencies to assess the costs and concerning its provisions or options for which guide the Coast Guard in benefits of available regulatory compliance, please contact the person complying with the National alternatives and, if regulation is listed in the FOR FURTHER INFORMATION Environmental Policy Act of 1969 (42 necessary, to select regulatory CONTACT section. The Coast Guard will U.S.C. 4321–4370f), and have made a approaches that maximize net benefits. not retaliate against small entities that preliminary determination that this Executive Order 13771 directs agencies question or complain about this action is one of a category of actions that to control regulatory costs through a proposed rule or any policy or action of do not individually or cumulatively budgeting process. This NPRM has not the Coast Guard. have a significant effect on the human been designated a ‘‘significant environment. This proposed rule C. Collection of Information regulatory action,’’ under Executive involves a safety zone lasting one hour Order 12866. Accordingly, the NPRM This proposed rule would not call for that would prohibit entry within a 100- has not been reviewed by the Office of a new collection of information under yard radius of a barge at approximate Management and Budget (OMB), and the Paperwork Reduction Act of 1995 position of 30°24′11.63″ N 090°09′17.39″ pursuant to OMB guidance it is exempt (44 U.S.C. 3501–3520). W on the Tchefuncte River. Normally

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such actions are categorically excluded List of Subjects in 33 CFR Part 165 DEPARTMENT OF HOMELAND from further review under paragraph Harbors, Marine safety, Navigation SECURITY L60(a) of Appendix A, Table 1 of DHS (water), Reporting and recordkeeping Coast Guard Instruction Manual 023–01–001–01, requirements, Security measures, Rev. 01. A preliminary Record of Waterways. Environmental Consideration 33 CFR Part 165 For the reasons discussed in the supporting this determination is preamble, the Coast Guard proposes to [Docket Number USCG–2018–0331] available in the docket where indicated amend 33 CFR part 165 as follows: under ADDRESSES. We seek any RIN 1625–AA00 comments or information that may lead PART 165—REGULATED NAVIGATION Safety Zone; Lower Mississippi River, to the discovery of a significant AREAS AND LIMITED ACCESS AREAS New Orleans, LA environmental impact from this proposed rule. ■ 1. The authority citation for part 165 AGENCY: Coast Guard, DHS. continues to read as follows: G. Protest Activities ACTION: Notice of proposed rulemaking. Authority: 33 U.S.C. 1231; 50 U.S.C. 191; The Coast Guard respects the First 33 CFR 1.05–1, 6.04–1, 6.04–6, and 160.5; SUMMARY: The Coast Guard proposes to Amendment rights of protesters. Department of Homeland Security Delegation establish a temporary safety zone for Protesters are asked to contact the No. 0170.1. certain navigable waters of the Mississippi River from mile marker person listed in the FOR FURTHER ■ 2. Add § 165.T08–0332 to read as (MM) 94 to MM 95 above Head of INFORMATION CONTACT section to follows: coordinate protest activities so that your Passes. This action is necessary to message can be received without § 165.T08–0332 Safety Zone; Tchefuncte provide for the safety of life on these jeopardizing the safety or security of River, New Orleans, LA. navigable waters near Algiers Point, people, places, or vessels. (a) Location. The following area is a New Orleans, LA, during a fireworks safety zone: All navigable waters of the display on June 30, 2018. This proposed V. Public Participation and Request for Tchefuncte River, 100-yards around a rulemaking would prohibit persons and Comments barge at approximate position vessels from being in the safety zone 30°24′11.63″ N 090°09′17.39″ W, in unless authorized by the Captain of the We view public participation as Port Sector New Orleans or a designated essential to effective rulemaking, and front of the Madisonville Town Hall in Madisonville, LA. representative. We invite your will consider all comments and material comments on this proposed rulemaking. received during the comment period. (b) Effective period. This section is DATES: Comments and related material Your comment can help shape the effective from 6:45 p.m. through 7:45 p.m. on July 4, 2018. must be received by the Coast Guard on outcome of this rulemaking. If you or before May 17, 2018. submit a comment, please include the (c) Regulations. (1) In accordance with docket number for this rulemaking, the general regulations in § 165.23 of ADDRESSES: You may submit comments this part, entry into this zone is indicate the specific section of this identified by docket number USCG– prohibited unless specifically document to which each comment 2018–0331 using the Federal authorized by the Captain of the Port applies, and provide a reason for each eRulemaking Portal at http:// Sector New Orleans (COTP) or suggestion or recommendation. www.regulations.gov. See the ‘‘Public designated representative. A designated Participation and Request for We encourage you to submit representative is a commissioned, Comments’’ portion of the comments through the Federal warrant, or petty officer of the U.S. SUPPLEMENTARY INFORMATION section for eRulemaking Portal at http:// Coast Guard assigned to units under the further instructions on submitting www.regulations.gov. If your material operational control of USCG Sector New comments. cannot be submitted using http:// Orleans. FOR FURTHER INFORMATION CONTACT: If www.regulations.gov, contact the person (2) Vessels requiring entry into this you have questions about this proposed in the FOR FURTHER INFORMATION safety zone must request permission rulemaking, call or email Lieutenant CONTACT section of this document for from the COTP or a designated Commander Howard Vacco, Sector New alternate instructions. representative. They may be contacted Orleans, U.S. Coast Guard; telephone on VHF–FM Channel 16 or 67 or by We accept anonymous comments. All 504–365–2281, email Howard.K.Vacco@ telephone at (504) 365–2200. comments received will be posted uscg.mil. without change to http:// (3) Persons and vessels permitted to SUPPLEMENTARY INFORMATION: www.regulations.gov and will include enter this safety zone must transit at any personal information you have their slowest safe speed and comply I. Table of Abbreviations provided. For more about privacy and with all lawful directions issued by the COTP or the designated representative. CFR Code of Federal Regulations the docket, visit http:// COTP Captain of the Port Sector New www.regulations.gov/privacyNotice. (d) Information broadcasts. The COTP Orleans or a designated representative will Documents mentioned in this NPRM DHS Department of Homeland Security inform the public through Broadcast as being available in the docket, and all FR Federal Register Notices to Mariners of any changes in MM Mile marker public comments, will be in our online the planned schedule. NPRM Notice of proposed rulemaking docket at http://www.regulations.gov § Section and can be viewed by following that Dated: April 11, 2018. U.S.C. United States Code website’s instructions. Additionally, if Wayne R. Arguin, you go to the online docket and sign up Captain, U.S. Coast Guard, Captain of the II. Background, Purpose, and Legal for email alerts, you will be notified Port Sector New Orleans. Basis when comments are posted or a final [FR Doc. 2018–07909 Filed 4–16–18; 8:45 am] On April 4, 2018, AFX Pro, LLC, rule is published. BILLING CODE 9110–04–P notified the Coast Guard that it would

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be conducting a fireworks display from A. Regulatory Planning and Review business, organization, or governmental 10 p.m. through 10:45 p.m. on June 30, Executive Orders 12866 and 13563 jurisdiction and you have questions 2018, for a wedding celebration. The direct agencies to assess the costs and concerning its provisions or options for fireworks are to be launched from a benefits of available regulatory compliance, please contact the person barge in the Mississippi River at alternatives and, if regulation is listed in the FOR FURTHER INFORMATION approximate mile marker (MM) 95.5 necessary, to select regulatory CONTACT section. The Coast Guard will above Head of Passes near Algiers Point, approaches that maximize net benefits. not retaliate against small entities that New Orleans, LA. Hazards from Executive Order 13771 directs agencies question or complain about this firework displays include accidental to control regulatory costs through a proposed rule or any policy or action of discharge of fireworks, dangerous budgeting process. This NPRM has not the Coast Guard. projectiles, and falling hot embers or been designated a ‘‘significant C. Collection of Information other debris. The Captain of the Port regulatory action,’’ under Executive Sector New Orleans (COTP) has This proposed rule would not call for Order 12866. Accordingly, the NPRM a new collection of information under determined that potential hazards has not been reviewed by the Office of associated with the fireworks to be used the Paperwork Reduction Act of 1995 Management and Budget (OMB), and (44 U.S.C. 3501–3520). in this display would be a safety pursuant to OMB guidance it is exempt concern for anyone within a one-mile from the requirements of Executive D. Federalism and Indian Tribal stretch of the river. Order 13771. Governments The purpose of this rulemaking is to This regulatory action determination A rule has implications for federalism ensure the safety of vessels on the is based on the size and duration of the under Executive Order 13132, navigable waters within a one-mile safety zone. This safety zone is for only Federalism, if it has a substantial direct stretch of the river before, during, and one hour on a one-mile section of the effect on the States, on the relationship after the fireworks display. The Coast waterway. Moreover, the Coast Guard between the national government and Guard proposes this rulemaking under would issue a Broadcast Notice to the States, or on the distribution of authority in 33 U.S.C. 1231. Mariners (BNM) via VHF–FM marine power and responsibilities among the III. Discussion of Proposed Rule channel 16 about the zone, and the rule various levels of government. We have would allow vessels to seek permission analyzed this proposed rule under that The COTP proposes to establish a to enter the zone. Order and have determined that it is safety zone from 9:45 p.m. through 11 consistent with the fundamental p.m. on June 30, 2018. The safety zone B. Impact on Small Entities federalism principles and preemption would cover all navigable waters of the The Regulatory Flexibility Act of requirements described in Executive Mississippi River above Head of Passes 1980, 5 U.S.C. 601–612, as amended, Order 13132. between mile markers (MM) 94 and 95. requires Federal agencies to consider Also, this proposed rule does not have The duration of the zone is intended to the potential impact of regulations on tribal implications under Executive ensure the safety of vessels and these small entities during rulemaking. The Order 13175, Consultation and navigable waters before, during, and term ‘‘small entities’’ comprises small Coordination with Indian Tribal after the scheduled fireworks display. businesses, not-for-profit organizations Governments, because it would not have No vessel or person would be permitted that are independently owned and a substantial direct effect on one or to enter the safety zone without operated and are not dominant in their more Indian tribes, on the relationship obtaining permission from the COTP or fields, and governmental jurisdictions between the Federal Government and a designated representative. A with populations of less than 50,000. Indian tribes, or on the distribution of designated representative is a The Coast Guard certifies under 5 U.S.C. power and responsibilities between the commissioned, warrant, or petty officer 605(b) that this proposed rule would not Federal Government and Indian tribes. of the U.S. Coast Guard assigned to have a significant economic impact on If you believe this proposed rule has units under the operational control of a substantial number of small entities. implications for federalism or Indian USCG Sector New Orleans. While some owners or operators of tribes, please contact the person listed Vessels requiring entry into this safety vessels intending to transit the safety in the FOR FURTHER INFORMATION zone must request permission from the zone may be small entities, for the CONTACT section. COTP or a designated representative. reasons stated in section IV.A above, They may be contacted on VHF–FM this proposed rule would not have a E. Unfunded Mandates Reform Act Channel 16 or 67 or by telephone at significant economic impact on any The Unfunded Mandates Reform Act (504) 365–2200. Persons and vessels vessel owner or operator. of 1995 (2 U.S.C. 1531–1538) requires permitted to enter this safety zone must If you think that your business, Federal agencies to assess the effects of transit at their slowest safe speed and organization, or governmental their discretionary regulatory actions. In comply with all lawful directions issued jurisdiction qualifies as a small entity particular, the Act addresses actions by the COTP or a designated and that this proposed rule would have that may result in the expenditure by a representative. The regulatory text we a significant economic impact on it, State, local, or tribal government, in the are proposing appears at the end of this please submit a comment (see aggregate, or by the private sector of document. ADDRESSES) explaining why you think it $100,000,000 (adjusted for inflation) or qualifies and how and to what degree IV. Regulatory Analyses more in any one year. Though this this rulemaking would economically proposed rule would not result in such We developed this proposed rule after affect it. an expenditure, we do discuss the considering numerous statutes and Under section 213(a) of the Small effects of this rule elsewhere in this Executive orders related to rulemaking. Business Regulatory Enforcement preamble. Below we summarize our analyses Fairness Act of 1996 (Pub. L. 104–121), based on a number of these statutes and we want to assist small entities in F. Environment Executive orders and we discuss First understanding this proposed rule. If the We have analyzed this proposed rule Amendment rights of protestors. rulemaking would affect your small under Department of Homeland

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Security Directive 023–01 and the docket, visit http:// Notices to Mariners of any changes in Commandant Instruction M16475.1D, www.regulations.gov/privacyNotice. the planned schedule. which guide the Coast Guard in Documents mentioned in this NPRM Dated: April 11, 2018. complying with the National as being available in the docket, and all Wayne R. Arguin, Environmental Policy Act of 1969 (42 public comments, will be in our online U.S.C. 4321–4370f), and have made a docket at http://www.regulations.gov Captain, U.S. Coast Guard, Captain of the Port Sector New Orleans. preliminary determination that this and can be viewed by following that action is one of a category of actions that website’s instructions. Additionally, if [FR Doc. 2018–07908 Filed 4–16–18; 8:45 am] do not individually or cumulatively you go to the online docket and sign up BILLING CODE 9110–04–P have a significant effect on the human for email alerts, you will be notified environment. This proposed rule when comments are posted or a final involves a safety zone lasting one hour rule is published. DEPARTMENT OF THE INTERIOR that would prohibit entry between mile marker 95 and mile marker 94 on the List of Subjects in 33 CFR Part 165 Fish and Wildlife Service Lower Mississippi River above Head of Harbors, Marine safety, Navigation Passes. Normally such actions are (water), Reporting and recordkeeping 50 CFR Part 17 categorically excluded from further requirements, Security measures, [4500030115] review under paragraph L60(a) of Waterways. Appendix A, Table 1 of DHS Instruction For the reasons discussed in the Endangered and Threatened Wildlife Manual 023–01–001–01, Rev. 01. A preamble, the Coast Guard proposes to and Plants; 90-Day Findings for Two preliminary Record of Environmental amend 33 CFR part 165 as follows: Species Consideration supporting this AGENCY: Fish and Wildlife Service, determination is available in the docket PART 165—REGULATED NAVIGATION Interior. where indicated under ADDRESSES. We AREAS AND LIMITED ACCESS AREAS seek any comments or information that ACTION: Notice of petition findings and may lead to the discovery of a ■ 1. The authority citation for part 165 initiation of a status review. continues to read as follows: significant environmental impact from SUMMARY: We, the U.S. Fish and this proposed rule. Authority: 33 U.S.C. 1231; 50 U.S.C. 191; Wildlife Service (Service), announce 90- 33 CFR 1.05–1, 6.04–1, 6.04–6, and 160.5; G. Protest Activities day findings on two petitions to list, Department of Homeland Security Delegation reclassify, or delist wildlife or plants The Coast Guard respects the First No. 0170.1. under the Endangered Species Act of Amendment rights of protesters. ■ 2. Add § 165.T08–0331 to read as 1973, as amended (Act). Based on our Protesters are asked to contact the follows: review, we find that one petition person listed in the FOR FURTHER presents substantial scientific or INFORMATION CONTACT section to § 165.T08–0331 Safety Zone; Lower commercial information indicating that coordinate protest activities so that your Mississippi River, New Orleans, LA. the petitioned action may be warranted. message can be received without (a) Location. The following area is a Therefore, with the publication of this jeopardizing the safety or security of safety zone: All navigable waters of the document, we announce that we plan to people, places, or vessels. Lower Mississippi River, New Orleans, LA from mile marker (MM) 94 to MM initiate a review of the status of that V. Public Participation and Request for 95 above Head of Passes. species to determine if the petitioned Comments (b) Effective period. This section is action is warranted. To ensure that this We view public participation as effective from 9:45 p.m. through 11 p.m. status review is comprehensive, we are essential to effective rulemaking, and on June 30, 2018. requesting scientific and commercial will consider all comments and material (c) Regulations. (1) In accordance with data and other information regarding received during the comment period. the general regulations in § 165.23 of this species. Based on the status review, Your comment can help shape the this part, entry into this zone is we will issue a 12-month finding on the outcome of this rulemaking. If you prohibited unless authorized by the petition, which will address whether or submit a comment, please include the Captain of the Port Sector New Orleans not the petitioned action is warranted, docket number for this rulemaking, (COTP) or designated representative. A in accordance with the Act. We also indicate the specific section of this designated representative is a find that one petition does not present document to which each comment commissioned, warrant, or petty officer substantial scientific or commercial applies, and provide a reason for each of the U.S. Coast Guard assigned to information indicating that the suggestion or recommendation. units under the operational control of petitioned action may be warranted. We encourage you to submit USCG Sector New Orleans. Therefore, we are not initiating a status comments through the Federal (2) Vessels requiring entry into this review of this species in response to that eRulemaking Portal at http:// safety zone must request permission petition. We refer to this finding as a www.regulations.gov. If your material from the COTP or a designated ‘‘not substantial’’ petition finding. cannot be submitted using http:// representative. They may be contacted DATES: These findings were made on www.regulations.gov, contact the person on VHF–FM Channel 16 or 67 or by April 17, 2018. As we commence work in the FOR FURTHER INFORMATION telephone at (504) 365–2200. on the status review, we seek any new CONTACT section of this document for (3) Persons and vessels permitted to information concerning the status of, or alternate instructions. enter this safety zone must transit at threats to, the species or its habitat. Any We accept anonymous comments. All their slowest safe speed and comply information received during our work comments received will be posted with all lawful directions issued by the on the status review will be considered. without change to http:// COTP or the designated representative. ADDRESSES: www.regulations.gov and will include (d) Information broadcasts. The COTP Supporting documents: Summaries of any personal information you have or a designated representative will the bases for the petition findings provided. For more about privacy and inform the public through Broadcast contained in this document are

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available on http://www.regulations.gov document, you may submit information generally means that we will post any under the appropriate docket number by clicking on ‘‘Comment Now!’’ If your personal information you provide us (see table under SUPPLEMENTARY information will fit in the provided (see Request for Information for Status INFORMATION). Supporting information in comment box, please use this feature of Reviews, below, for more information). preparing these findings is available for http://www.regulations.gov, as it is most Not-substantial petition finding: A public inspection, by appointment, compatible with our information review summary of the basis for the not- during normal business hours by procedures. If you attach your contacting the appropriate person, as information as a separate document, our substantial petition finding contained in specified in FOR FURTHER INFORMATION preferred file format is Microsoft Word. this document is available on http:// CONTACT. If you attach multiple comments (such www.regulations.gov under the Submitting information: If you have as form letters), our preferred format is appropriate docket number (see Table 2 new scientific or commercial data or a spreadsheet in Microsoft Excel. under SUPPLEMENTARY INFORMATION). other information concerning the status (2) By hard copy: Submit by U.S. mail Supporting information in preparing of, or threats to, the species for which or hand-delivery to: Public Comments this finding is available for public we made these petition findings, or their Processing, Attn: [Insert appropriate inspection, by appointment, during habitats, please submit that information docket number; see Table 1 under normal business hours by contacting the by one of the following methods: SUPPLEMENTARY INFORMATION], U.S. Fish appropriate person, as specified under (1) Electronically: Go to the Federal and Wildlife Service, MS: BPHC, 5275 FOR FURTHER INFORMATION CONTACT. If eRulemaking Portal: http:// Leesburg Pike; Falls Church, VA 22041– you have new information concerning www.regulations.gov. In the Search box, 3803. the status of, or threats to, this species, enter the appropriate docket number We request that you send information or its habitat, please submit that SUPPLEMENTARY (see Table 1 under only by the methods described above. information to the appropriate person. INFORMATION). Then, click on the Search We will post all information we receive button. After finding the correct on http://www.regulations.gov. This FOR FURTHER INFORMATION CONTACT:

Common name Contact person

Cape mountain zebra ...... Bridget Fahey, 703–358–2163; [email protected]. Preble’s meadow jumping mouse ...... Mike Thabault, 303–236–4210; [email protected].

SUPPLEMENTARY INFORMATION: petition may be warranted’’ (50 CFR species. The term ‘‘threat’’ includes 424.14(h)(1)(i)). actions or conditions that have a direct Background A species may be determined to be an impact on individuals (direct impacts), Section 4 of the Act (16 U.S.C. 1533) endangered or threatened species as well as those that affect individuals and its implementing regulations in title because of one or more of the five through alteration of their habitat or 50 of the Code of Federal Regulations factors described in section 4(a)(1) of the required resources (stressors). The term (50 CFR part 424) set forth the Act (16 U.S.C 1531 et seq.). The five ‘‘threat’’ may encompass—either procedures for adding a species to, or factors are: together or separately—the source of the removing a species from, the Federal (a) The present or threatened action or condition or the action or Lists of Endangered and Threatened destruction, modification, or condition itself. However, the mere Wildlife and Plants (Lists). Section curtailment of its habitat or range identification of any threat(s) may not 4(b)(3)(A) of the Act requires that we (Factor A); be sufficient to compel a finding that the make a finding on whether a petition to (b) Overutilization for commercial, information in the petition is substantial add a species to the Lists (i.e., ‘‘list’’), recreational, scientific, or educational information indicating that the remove a species from the Lists (i.e., purposes (Factor B); petitioned action may be warranted. The ‘‘delist’’), or to change a listed species’ (c) Disease or predation (Factor C); information presented in the petition status from endangered to threatened, or (d) The inadequacy of existing must include evidence sufficient to from threatened to endangered (i.e., regulatory mechanisms (Factor D); or suggest that these threats may be ‘‘reclassify’’) presents substantial (e) Other natural or manmade factors affecting the species to the point that the scientific or commercial information affecting its continued existence (Factor species may meet the definition of an indicating that the petitioned action E). ‘‘endangered’’ species or ‘‘threatened’’ may be warranted. To the maximum These factors represent broad categories species under the Act. extent practicable, we are to make this of natural or human-caused actions or If we find that a petition presents finding within 90 days of our receipt of conditions that could have an effect on such information, our subsequent status the petition and publish the finding a species’ continued existence. In review will evaluate all identified promptly in the Federal Register. evaluating these actions and conditions, threats by considering the individual, Our regulations in the Code of Federal we look for those that may have a population, and species-level effects, Regulations (CFR) establish that negative effect on individuals of the and the expected response by the substantial scientific or commercial species, as well as other actions or species. We will evaluate individual information with regard to a 90-day conditions that may ameliorate any threats and their expected effects on the petition finding refers to ‘‘credible negative effects or may have positive species, then analyze the cumulative scientific or commercial information in effects. effect of the threats on the species as a support of the petition’s claims such We use the term ‘‘threat’’ to refer in whole. We also consider the cumulative that a reasonable person conducting an general to actions or conditions that are effect of the threats in light of those impartial scientific review would known to or are reasonably likely to actions and conditions that will have conclude that the action proposed in the negatively affect individuals of a positive effects on the species—such as

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any existing regulatory mechanisms or If we find that a petition presents Summaries of Petition Findings conservation efforts that may ameliorate substantial scientific or commercial threats. It is only after conducting this information, the Act requires us to The petition findings contained in cumulative analysis of threats and the promptly commence a review of the this document are listed in the tables actions that may ameliorate them, and status of the species, and we will below and the bases for the findings, the expected effect on the species now subsequently complete a status review along with supporting information, are and in the foreseeable future, that we in accordance with our prioritization available on http://www.regulations.gov can determine whether the species methodology for 12-month findings (81 under the appropriate docket number. meets the definition of an ‘‘endangered FR 49248; July 27, 2016). species’’ or ‘‘threatened species.’’

TABLE 1—STATUS REVIEW

Common name Docket No. URL to docket on http://www.regulations.gov.

Cape mountain zebra ...... FWS–HQ–ES–2017–0100 https://www.regulations.gov/docket?D=FWS-HQ-ES-2017-0100.

TABLE 2—NOT-SUBSTANTIAL PETITION FINDING

Common name Docket No. URL to docket on http://www.regulations.gov

Preble’s meadow jumping mouse ...... FWS–R6–ES–2017–0102 https://www.regulations.gov/docket?D=FWS-R6-ES-2017-0102.

Evaluation of a Petition To Delist the will thoroughly evaluate all potential taxonomic information. The petition Cape Mountain Zebra or Reclassify the threats to the subspecies, including the clearly identified itself as such and Subspecies as a Threatened Species extent to which any protections or other included the requisite identification Under the Act conservation efforts have reduced those information for the petitioners, required threats. Thus, for this subspecies, the at 50 CFR 424.14(c). This finding Species and Range Service requests any information addresses the petition. Cape mountain zebra (Equus zebra relevant to whether the subspecies falls Finding zebra): South Africa (Eastern and within the definition of either Western Cape provinces). ‘‘endangered species’’ under section 3(6) Based on our review of the petition and the source cited in the petition, we Petition History of the Act or ‘‘threatened species’’ under section 3(20) of the Act, including find that the petition presents no On May 10, 2017, we received a information on the five listing factors additional or new information that petition dated May 10, 2017, from under section 4(a)(1) (see Request for would support a taxonomic revision for Conservation Force and the Professional Information for Status Reviews, below). the Preble’s mouse or that would Hunters Association of South Africa The basis for our finding on this indicate that the subspecies is not a requesting that we delist the Cape petition, and other information valid entity under the Act. Therefore, mountain zebra (Equus zebra zebra) or regarding our review of the petition, can we find that the petition does not reclassify the subspecies from an be found as an appendix at http://www. present substantial scientific or endangered species to a threatened regulations.gov under Docket No. FWS– commercial information indicating that species under the Act. The petition HQ–ES–2017–0100 under Supporting delisting the Preble’s meadow jumping clearly identified itself as such and Documents. mouse may be warranted. Because the included the requisite identification petition does not present substantial information for the petitioner, required Evaluation of a Petition To Delist the information indicating that delisting the at 50 CFR 424.14(c). This finding Preble’s Meadow Jumping Mouse Preble’s meadow jumping mouse may addresses the petition. Under the Act be warranted, we are not initiating a Finding Species and Range status review of this species in response to this petition. However, we ask that Based on our review of the petition Preble’s meadow jumping mouse the public submit to us any new and sources cited in the petition, we (Zapus hudsonius preblei): Colorado information that becomes available find that the petition presents and Wyoming. concerning the status of, or threats to, substantial scientific or commercial Petition History this species or its habitat at any time information indicating that the (see Not-substantial petition finding petitioned action may be warranted for On March 30, 2017, we received a under ADDRESSES, above). the Cape mountain zebra due to the petition dated March 29, 2017, from The basis for our finding on this reduction or elimination of threats Pacific Legal Foundation (on behalf of petition, and other information related to the following: Habitat Dr. Rob Roy Ramey II; Center for regarding our review of this petition, availability (Factor A); commercial and Environmental Science, Accuracy and can be found as an appendix at http:// recreational use (Factor B); disease and Reliability; Wyoming Stock Growers www.regulations.gov under Docket No. predation (Factor C); hybridization and Association; Colorado Cattlemen’s FWS–R6–ES–2017–0102 under inbreeding (Factor E); and the Association; Colorado Association of Supporting Documents. inadequacy of existing regulations with Home Builders; and Housing and regards to a number of these threats Building Association of Colorado Request for Information for Status (Factor D) (for information about these Springs), requesting that the Preble’s Reviews factors, see Background, above). meadow jumping mouse be delisted When we make a finding that a However, during our status review, we under the Act due to an error in petition presents substantial

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information indicating that listing, You may submit your information under section 4(b)(3)(A) of the Act, we reclassification, or delisting of a species concerning the status review by one of have determined that the petition may be warranted, we are required to the methods listed in ADDRESSES. If you summarized above for the Cape review the status of the species (a status submit information via http:// mountain zebra presents substantial review). For the status review to be www.regulations.gov, your entire scientific or commercial information complete and based on the best submission—including any personal indicating that the petitioned action available scientific and commercial identifying information—will be posted may be warranted. We are, therefore, information, we request information on on the website. If you submit a initiating a status review to determine the species from governmental agencies, hardcopy that includes personal whether the action is warranted under Native American Tribes, the scientific identifying information, you may the Act. At the conclusion of the status community, industry, and any other request at the top of your document that review, we will issue a finding, in interested parties. We seek information we withhold this personal identifying accordance with section 4(b)(3)(B) of the on: information from public review. Act, as to whether the petitioned action (1) The species’ biology, range, and However, we cannot guarantee that we is not warranted, warranted, or population trends, including: will be able to do so. We will post all warranted but precluded by pending (a) Habitat requirements; hardcopy submissions on http:// proposals to determine whether any (b) Genetics and taxonomy; www.regulations.gov. species is an endangered species or a (c) Historical and current range, threatened species. including distribution patterns; and It is important to note that the (d) Historical and current population standard for a 90-day finding differs In addition, we have determined that levels and current and projected trends. from the Act’s standard that applies to the petition summarized above for the (2) The five factors described in a status review to determine whether a Preble’s meadow jumping mouse does section 4(a)(1) of the Act (see petitioned action is warranted. In not present substantial scientific or Background, above) that are the basis for making a 90-day finding, we consider commercial information indicating that making a listing, reclassification, or information in the petition and sources the requested actions may be warranted. delisting determination for a species cited in the petition, as well as Therefore, we are not initiating a status under section 4(a) of the Act, including information that is readily available, review for this species. and we evaluate merely whether that past and ongoing conservation measures Authors that could decrease the extent to which information constitutes ‘‘substantial one or more of the factors affect the information’’ indicating that the The primary authors of this document species, its habitat, or both. petitioned action ‘‘may be warranted.’’ are staff members of the Ecological (3) The potential effects of climate In a 12-month finding, we must Services Program, U.S. Fish and change on the species and its habitat, complete a thorough status review of the Wildlife Service. and the extent to which it affects the species and evaluate the ‘‘best scientific Authority habitat or range of the species. and commercial data available’’ to Submissions merely stating support determine whether a petitioned action The authority for these actions is the for or opposition to the actions under ‘‘is warranted.’’ Because the Act’s Endangered Species Act of 1973, as consideration without providing standards for 90-day and 12-month amended (16 U.S.C. 1531 et seq.). supporting information, although noted, findings are different, a substantial 90- Dated: February 23, 2018. will not be considered in making a day finding does not mean that the 12- determination. Section 4(b)(1)(A) of the month finding will result in a James W. Kurth, Act directs that determinations as to ‘‘warranted’’ finding. Deputy Director, U.S. Fish and Wildlife whether any species is an endangered or Service, Exercising the Authority of the Conclusion Director, U.S. Fish and Wildlife Service. threatened species must be made ‘‘solely on the basis of the best scientific On the basis of our evaluation of the [FR Doc. 2018–07707 Filed 4–16–18; 8:45 am] and commercial data available.’’ information presented in the petitions BILLING CODE 4333–15–P

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Notices Federal Register Vol. 83, No. 74

Tuesday, April 17, 2018

This section of the FEDERAL REGISTER community. Speakers include Dr. Greg Board will address old and new contains documents other than rules or Collins, Director of USAID’s Center for business and hear updates from USAID proposed rules that are applicable to the Resilience and Dr. Mark Constas, and the university community. The public. Notices of hearings and investigations, Associate Professor at Cornell purpose of the meeting is to develop a committee meetings, agency decisions and University, and Chair of the Food and shared understanding of rural labor rulings, delegations of authority, filing of petitions and applications and agency Nutrition Security Resilience markets and youth-specific constraints, statements of organization and functions are Measurement Technical Working discuss the evidence base on programs examples of documents appearing in this Group. that aim to improve rural youth section. At 4:00 p.m. ET, Acting Chairman employment and livelihoods, outline Deaton will moderate a half-hour public cross-sectoral opportunities to support comment period. At 5:00 p.m., Dr. and empower youth to take advantage of AGENCY FOR INTERNATIONAL Deaton will make closing remarks and agricultural system market DEVELOPMENT adjourn the public meeting. opportunities, and identify knowledge Those wishing to attend the meeting gaps on which U.S. university research Board for International Food and or obtain additional information about partners can generate evidence to Agricultural Development; Notice of BIFAD should contact Clara Cohen, address. Meeting Designated Federal Officer for BIFAD in the Bureau for Food Security at USAID. Following the opening remarks, the Pursuant to the Federal Advisory Interested persons may write to her in meeting will feature experts as well as Committee Act, notice is hereby given of care of the U.S. Agency for International panel discussions on the following the public meeting of the Board for Development, Ronald Reagan Building, topics: International Food and Agricultural Bureau for Food Security, 1300 • A Conceptual Framework on Youth Development (BIFAD). The meeting will Pennsylvania Avenue NW, Washington, and Agricultural Transformation; be held from 9:00 a.m. to 5:00 p.m. ET DC, 20523–2110 or telephone her at • Framing the Evidence Base on Rural on Wednesday, May 9, 2018, at the (202) 712–0119. Rotunda, Ronald Reagan Building and Youth Employment and Livelihoods; International Trade Center, 1300 Clara Cohen, • Youth Perspectives: Challenges and Pennsylvania Ave. NW, Washington, Designated Federal Officer, BIFAD, Bureau Opportunities in the Agricultural and DC. Participants may attend in person or for Food Security, U.S. Agency for Food Sectors; International Development. join via livestream. The link to the • Youth Productivity: Technology, global live stream as well as registration [FR Doc. 2018–07968 Filed 4–16–18; 8:45 am] Mechanization, and Global Value information can be found on BIFAD’s BILLING CODE P Chains; home page: http://www.usaid.gov/bifad. • The central theme of this public Gender Considerations and Youth meeting will be Resilience Measurement AGENCY FOR INTERNATIONAL Employment; and Analysis. Dr. Brady Deaton, Acting DEVELOPMENT • Research, Learning and USAID BIFAD Chair, will preside over the Programming: The Role of U.S. public business meeting, which will Board for International Food and University Research Partners in begin promptly at 9:00 a.m. ET with Agricultural Development; Notice of Generating Evidence. Meeting opening remarks. At this meeting, the The meeting will be chaired by Dr. Board will address old and new Pursuant to the Federal Advisory Brady Deaton, Acting BIFAD Chair and business, including the presentation of Committee Act, notice is hereby given of Chancellor Emeritus of the University of the BIFAD Award for Scientific the public meeting of the Board for Missouri. Expert speakers include Dr. Excellence in an Innovation Lab. The International Food and Agricultural Louise Fox, USAID Chief Economist and purpose of this meeting is to share Development (BIFAD). The meeting will Dr. David Tschirley, Food Security knowledge about theoretical and be held from 9:00 a.m. to 5:00 p.m. ET Group Co-Director, Michigan State applied frameworks for resilience on Tuesday, May 8, 2018, at the University. measurement and analysis and to Rotunda, Ronald Reagan Building and identify opportunities to leverage U.S. International Trade Center, 1300 At 4:15 p.m. ET, Acting Chairman university research capabilities to Pennsylvania Ave. NW, Washington, Deaton will moderate a half-hour public support resilience measurement and DC. Participants may attend in person or comment period. At 5:00 p.m., Dr. analysis. This event responds to join via livestream. The link to the Deaton will make closing remarks and priorities identified during the BIFAD global live stream as well as registration adjourn the public meeting. meeting at the 2017 World Food Prize information can be found on BIFAD’s Those wishing to attend the meeting and the 2017 USAID Resilience home page: http://www.usaid.gov/bifad. or obtain additional information about Evidence Summit. The central theme of this public BIFAD should contact Clara Cohen, The meeting will be chaired by Dr. meeting will be Building an Evidence Designated Federal Officer for BIFAD in Brady Deaton, Acting BIFAD Chair and Base on Rural Youth Employment and the Bureau for Food Security at USAID. Chancellor Emeritus of the University of Livelihoods. Dr. Brady Deaton, Acting Interested persons may write to her in Missouri. The meeting will feature BIFAD Chair, will preside over the care of the U.S. Agency for International thought leaders on resilience public business meeting, which will Development, Ronald Reagan Building, measurement and analysis from USAID, begin promptly at 9:00 a.m. ET with Bureau for Food Security, 1300 academia and the practitioner opening remarks. At this meeting, the Pennsylvania Avenue NW, Washington,

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DC, 20523–2110 or telephone her at requirements of 35 U.S.C. 209 and 37 agreed to pay the USDA Forest Service, (202) 712–0119. CFR 404.7. Northern Region, $219,308 to reimburse it for certain response actions the USDA Clara Cohen, Mojdeh Bahar, Forest Service, Northern Region, has Designated Federal Officer, BIFAD, Bureau Assistant Administrator. undertaken at the Site. The settlement for Food Security, U.S. Agency for [FR Doc. 2018–07977 Filed 4–16–18; 8:45 am] includes a covenant not to sue Grace for International Development. BILLING CODE 3410–03–P certain past costs pursuant to sections [FR Doc. 2018–07966 Filed 4–16–18; 8:45 am] 106 and 107(a) of CERCLA, 42 U.S.C. BILLING CODE P 9606 and 9607(a), with regard to the DEPARTMENT OF AGRICULTURE Site. For thirty (30) days following the date Forest Service of publication of this notice, the United DEPARTMENT OF AGRICULTURE Notice of Settlement Pursuant to States will receive written comments CERCLA; Libby Asbestos Site, Lincoln relating to the settlement. The United Agricultural Research Service County, MT States will consider all comments received and may modify or withdraw Notice of Intent To Grant Exclusive AGENCY: Forest Service, USDA. its consent to the settlement if License ACTION: Notice. comments received disclose facts or considerations which indicate that the AGENCY: Agricultural Research Service, SUMMARY: In accordance with the settlement is inappropriate, improper, USDA. Comprehensive Environmental or inadequate. The United States Response, Compensation, and Liability ACTION: Notice of intent. response to any comments received will Act, as amended (CERCLA), notice is be available for public inspection at the hereby given of an administrative SUMMARY: Notice is hereby given that Libby Ranger District, Canoe Gulch settlement with W.R. Grace & Co. Conn. Ranger Station, 12557 MT Hwy. 37, the U.S. Department of Agriculture, and the Kootenai Development Agricultural Research Service, intends Libby, MT 59923, and at the offices of Company (Grace) for the recovery of the USDA Forest Service, Northern to grant to Koppert B.V. of The past response costs concerning Operable Netherlands, an exclusive license to Region, 26 Fort Missoula Road, Unit 3 (OU3) of the Libby Asbestos Site, Missoula, MT 59804. U.S. Patent Application Serial No. 14/ Lincoln County, Montana (the Site). Dated: March 14, 2018. 854,120, ‘‘STABLE FUNGAL DATES: Comments must be submitted on Chris French, BLASTOSPORES AND METHODS FOR or before May 17, 2018. THEIR PRODUCTION, STABILIZATION Associate Deputy Chief, National Forest ADDRESSES: The proposed settlement is AND USE’’, filed on September 15, System. available for public inspection at the 2015. [FR Doc. 2018–07933 Filed 4–16–18; 8:45 am] Libby Ranger District, Canoe Gulch BILLING CODE 3411–15–P DATES: Comments must be received on Ranger Station, 12557 MT Hwy. 37, or before May 17, 2018. Libby, MT 59923, and at the offices of the USDA Forest Service, Northern DEPARTMENT OF AGRICULTURE ADDRESSES: Send comments to: USDA, Region, 26 Fort Missoula Road, ARS, Office of Technology Transfer, Missoula, MT 59804. A copy of the Forest Service 5601 Sunnyside Avenue, Rm. 4–1174, proposed settlement may be obtained Beltsville, Maryland 20705–5131. from Jeff Johnson at (208) 765–7313, Information Collection; Forest Products Removal Permits and FOR FURTHER INFORMATION CONTACT: Pamela Baltz (406) 283–7597, or from Contracts Brian T. Nakanishi of the Office of Babak Rastgoufard, USDA Office of the Technology Transfer at the Beltsville General Counsel at (406) 329–3061. AGENCY: Forest Service, USDA. Comments should reference the Libby address given above; telephone: 301– ACTION: Notice; request for comment. Asbestos Site OU3, and should be 504–5989. addressed to Babak Rastgoufard, USDA SUMMARY: In accordance with the SUPPLEMENTARY INFORMATION: The Office of the General Counsel, 26 Fort Paperwork Reduction Act of 1995, the Federal Government’s patent rights in Missoula Road, Missoula, MT 59804. Forest Service is seeking comments this invention are assigned to the United FOR FURTHER INFORMATION CONTACT: For from all interested parties on the States of America, as represented by the technical information, contact Jeff extension of a currently approved Secretary of Agriculture. It is in the Johnson, USDA Forest Service Northern information collection, Forest Products public interest to so license this Region, 3815 N Schreiber Way, Coeur Removal Permits and Contracts. invention as Koppert B.V. of The d’Alene, ID 83815; phone (208) 765– DATES: Comments must be received in Netherlands has submitted a complete 7313 or Pamela Baltz, Kootenai National writing on or before June 18, 2018 to be and sufficient application for a license. Forest, 12557 Hwy. 37, Libby, MT assured of consideration. Comments The prospective exclusive license will 59923; phone (406) 283–7597. For legal received after that date will be be royalty-bearing and will comply with information, contact Babak Rastgoufard, considered to the extent practicable. the terms and conditions of 35 U.S.C. USDA Office of the General Counsel, 26 ADDRESSES: Comments concerning this 209 and 37 CFR 404.7. The prospective Fort Missoula Road, Missoula, MT notice should be addressed to Director, exclusive license may be granted unless, 59804; phone (406) 329–3061. Forest & Rangeland Management and within thirty (30) days from the date of SUPPLEMENTARY INFORMATION: Pursuant Vegetation Ecology, Forest Service, this published Notice, the Agricultural to section 122(h)(1) of CERCLA, 42 USDA, Mail Stop 1103, 1400 Research Service receives written U.S.C. 9622(h)(1), the settlement Independence Avenue SW, Washington evidence and argument which agreement resolves, in part, response DC 20250–1103. establishes that the grant of the license costs incurred by the Forest Service at Comments may also be submitted via would not be consistent with the OU3. Under the settlement, Grace has facsimile to (703) 605–1575 or by email

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to [email protected]. In submitted to the local Forest Service Each form listed above implements addition, comments may be submitted District Ranger’s Office(s) in writing. different regulations and has different via the world wide web/internet at: Requests may be made: (1) Directly by provisions for compliance, but collects http://www.regulations.gov. a tribal official(s) who has been similar information from the applicant The public may inspect comments authorized by the Indian tribe to make for related purposes. received at the Forest Service, Forest such requests; or (2) By providing a The Forest Service and the Bureau of Management Staff Office, Third Floor copy of a formal resolution approved by Land Management will use the SW Wing, 201 14th Street SW, the tribal council or other governing information collected on form FS–2400– Washington, DC 20250 during normal body of the Indian tribe.’’ Note: there is 1, to ensure identification of permittees business hours. Visitors are encouraged no stated maximum free use limitation in the field by agency personnel. The to call ahead to (202) 205–1766 to for products requested by Indian tribes, Forest Service will use the information facilitate entry to the building. and there is no limitation to the number collected on forms FS–2400–4/FS– FOR FURTHER INFORMATION CONTACT: of requests that each federally 2400–4ANF and/or FS–2400–8 to: Sharon Nygaard-Scott, Forest recognized Indian tribe may make, • Ensure that permittees obtaining Management Staff, at (202) 205–1766. under section 8105 authority. Should free use of timber or forest products Individuals who use telecommunication federally recognized Indian tribes qualify for the free-use program. devices for the deaf (TDD) may call the seeking such use wish to obtain proof of • Ensure that permittees obtaining Federal Relay Service (FRS) at 1–800– possession, as may be required in some free use of timber or forest products, 877–8339 twenty-four hours a day, States, they could be issued a FS–2400– under 36 CFR 223.8, do not receive every day of the year, including 8 permit which allows use of timber or product value in excess of that allowed holidays. forest products at no charge (36 CFR by regulations. However, as noted above 223.5–223.13). for federally recognized Indian Tribe SUPPLEMENTARY INFORMATION: Upon receiving a permit, the Title: Forest Products Removal requests made under section 8105 permittee must comply with the terms authority, there is no stated maximum Permits and Contracts. of the permit (36 CFR 261.6), which OMB Number: 0596–0085. free use limitation (25 U.S.C. 3055). designates the forest products that can • Ensure that applicants purchasing Expiration Date of Approval: October be harvested and under what 31, 2018. timber harvest or forest products conditions, such as limiting harvest to a permits non-competitively do not Type of Request: Extension of a designated area or permitting harvest of currently approved information exceed the authorized limit in a fiscal only specifically designated material. year (16 U.S.C. 472(a)). collection. The collected information will help the • Ensure identification of permittees, Abstract: Under 16 U.S.C. 551 Forest Service and the Bureau of Land in the field, by Forest Service personnel. Protection of National Forests; Rules Management (for form FS–2400–1) Applicants may apply for more than and Regulations, individuals and oversee the approval and use of forest one forest product permit or contract businesses wishing to remove forest products by the public. products from National Forest System When applying for forest product per year. For example, an applicant may lands must request a permit. To obtain removal permits, applicants (depending obtain a free use permit for a timber a permit, applicants must meet the on the products requested) would product such as, but not limited to, pine criteria at 36 CFR 223.1, 223.2, and provide information needed to complete cones (FS–2400–8) and still purchase 223.5–223.13, which authorizes free use one of the following: fuelwood (FS–2400–1, and/or FS–2400– or sale of timber or forest products. • FS–2400–1, Forest Products 4/2400–4ANF). Additionally, as noted Under the Food, Conservation, and Removal Permit and Cash Receipt, is above, there is no limitation to the Energy Act of 2008 (Pub. L. 110–246, used to sell timber or forest products number of requests that each federally 122 Stat. 1651) section 8105 Forest such as, but not limited to, fuelwood, recognized Indian tribe may make under Products for Traditional and Cultural Christmas trees, or pine cones (36 CFR section 8105 authority (25 U.S.C. 3055). Purposes [hereinafter referred to as 223.1, 223.2). The Bureau of Land Individuals and small business ‘‘section 8105’’], federally recognized Management identifies the FS–2400–1 representatives usually request and Indian tribes may make a request for as BLM–5450–24 (43 U.S.C 1201, 43 apply for permits and contracts in free use of trees, portions of trees, or CFR 5420). This form would not be used person at the office issuing the permit. forest products for traditional and to issue products requested by federally As noted above, Indian tribes seeking cultural purposes, provided the use will recognized Indian tribes under section products under section 8105 authority not be for commercial purposes. Section 8105 authority. must make a written request for free use, 8105 has been codified in 25 U.S.C. • FS–2400–4/FS–2400–4ANF, Forest following the criteria at 36 CFR 223.15. chapter 32A Cultural and Heritage Products Contract and Cash Receipt, are Applicants provide the following Cooperation Authority, section 3055 used to sell timber products such as information, as applicable: Forest Products for Traditional and sawtimber or forest products such as, • Name, Cultural Purposes (25 U.S.C. 3055). but not limited to, fuelwood, or posts • Address, and Additionally, Forest Service issued final and poles. These forms would not be • Personal identification number implementation regulations, for section used to issue products requested by such as tax identification number, social 8105, at 36 CFR 223.15 Provision of federally recognized Indian tribes under security number, driver’s license Trees, Portions of Trees, or Forest section 8105 authority. number, or other unique number Products to Indian Tribes for • FS–2400–8, Forest Products Free identifying the applicant. Traditional and Cultural Purposes. Use Permit, allows use of timber or Agency personnel enter the Indian tribes seeking products, under forest products at no charge to the information into a computerized section 8105 authority, must make a permittee (36 CFR 223.5–223.13). This database to use for subsequent requests request for free use, following the form could be used to issue products by applicants for a forest product permit criteria at 36 CFR 223.15, which requested by federally recognized or contract. The information is printed includes: ‘‘Requests for trees, portions of Indian tribes under section 8105 on paper, which the applicant signs and trees, or forest products . . . must be authority. dates. Agency personnel discuss the

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terms and conditions of the permit or be summarized and included in the Regional Programs Unit at (213) 894– contract with the applicant. submission request toward Office of 3437. The data gathered is not available Management and Budget approval. Records and documents discussed from other sources. The collected data is Dated: March 28, 2018. during the meeting will be available for used to ensure: public viewing prior to and after the Glenn Casamassa, • Applicants for free use permits meeting at https://facadatabase.gov/ meet the criteria for free use of timber Associate Deputy Chief, National Forest committee/meetings.aspx?cid=270. System. or forest products authorized by Please click on the ‘‘Meeting Details’’ regulations at 36 CFR 223.5–223.13; [FR Doc. 2018–07934 Filed 4–16–18; 8:45 am] and ‘‘Documents’’ links. Records and, for federally recognized Indian BILLING CODE 3411–15–P generated from this meeting may also be tribes under section 8105 authority, the inspected and reproduced at the criteria at 36 CFR 223.15; Regional Programs Unit, as they become • Applicants seeking to purchase and COMMISSION ON CIVIL RIGHTS available, both before and after the remove timber or forest products from meeting. Persons interested in the work Agency lands meet the criteria under Notice of Public Meeting of the Oregon of this Committee are directed to the which sale of timber or forest products Advisory Committee to the U.S. Commission’s website, https:// is authorized by regulations at 36 CFR Commission on Civil Rights www.usccr.gov, or may contact the 223.80; and Regional Programs Unit at the above • Permittees comply with regulations AGENCY: U.S. Commission on Civil email or street address. and terms of the permit at 36 CFR 261.6. Rights. Agenda The collection of this information is ACTION: Announcement of meeting. necessary to ensure that applicants meet Opening Remarks (2:00–2:10 p.m.) the requirements of the forest products SUMMARY: Notice is hereby given, program; those obtaining free-use pursuant to the provisions of the rules Panel—Sex Trafficking (2:10–3:50 p.m.) permits for forest products qualify for and regulations of the U.S. Commission • Senator Kathleen Taylor, District 21 the program; applicants purchasing non- on Civil Rights (Commission) and the • Chanpone Sinlapasai, Attorney, competitive permits to harvest forest Federal Advisory Committee Act that Marandas Sinlapasai products do not exceed authorized the Oregon Advisory Committee • Natalie Weaver, Collaboration limits; and that Federal Agency (Committee) will hold a community Specialist focus on Sex Trafficking, employees can identify permittees when forum on Tuesday, May 1, 2018, from Multnomah County, Department of in the field. 2:00 p.m.–5:00 p.m. PST for the purpose Community Justice Estimate of Annual Burden: 5 of hearing public testimony on civil • Desiree´ Coyote, Confederated Tribes minutes. rights concerns of human and labor of Umatilla Indian Reservation, Type of Respondents: Individuals, trafficking in the sex, agriculture, and Family Violence Services small businesses, and, for requests made forestry industries and equal protection • Robin Miller, Mentor and Survivor, under section 8105 of the Food, violations and discrimination based Janus Youth Programs Conservation, and Energy Act of 2008 upon race, national origin, religion, sex, • Cristin Casey, Chief Prosecutor, (Pub. L. 110–246, 122 Stat. 1651), disability, and/or age of survivors. It Bureau of Labor and Industries federally recognized Indian tribes. will also examine the effectiveness of Open Public Comment (4:00–4:55 p.m.) Estimated Annual Number of state and local agency programs for Respondents: 192,224. trafficking survivors. Dated: April 11, 2018. Estimated Annual Number of DATES: The meeting will be held on David Mussatt, Responses per Respondent: 2. Tuesday, May 1, 2018, at 2:00 p.m. PST Estimated Total Annual Burden on Supervisory Chief, Regional Programs Unit. to 5:00 p.m. PST. Respondents: 32,037. [FR Doc. 2018–07897 Filed 4–16–18; 8:45 am] Location: Portland Community Comment is invited on: (1) Whether BILLING CODE P College, Sylvania Campus, CC Building, this collection of information is Room 233, 12000 SW 49th Avenue, necessary for the stated purposes and Portland, OR 97280. the proper performance of the functions COMMISSION ON CIVIL RIGHTS of the agency, including whether the FOR FURTHER INFORMATION CONTACT: Ana Agenda and Notice of Public Meeting information will have practical or Victoria Fortes (DFO) at afortes@ of the Rhode Island Advisory scientific utility; (2) the accuracy of the usccr.gov or (213) 894–3437. Committee agency’s estimate of the burden of the SUPPLEMENTARY INFORMATION: Members collection of information, including the of the public are entitled to make AGENCY: Commission on Civil Rights. validity of the methodology and comments during the open comment ACTION: Announcement of meetings. assumptions used; (3) ways to enhance periods. Members of the public may also the quality, utility, and clarity of the submit written comments; the SUMMARY: Notice is hereby given, information to be collected; and (4) comments must be received in the pursuant to the provisions of the rules ways to minimize the burden of the Regional Programs Unit within 30 days and regulations of the U.S. Commission collection of information on following the meeting. Written on Civil Rights (Commission), and the respondents, including the use of comments may be mailed to the Western Federal Advisory Committee Act automated, electronic, mechanical, or Regional Office, U.S. Commission on (FACA), that a planning meeting of the other technological collection Civil Rights, 300 North Los Angeles Rhode Island State Advisory Committee techniques or other forms of information Street, Suite 2010, Los Angeles, CA to the Commission will convene by technology. 90012. They may be faxed to the conference call, on Tuesday, May 1, All comments received in response to Commission at (213) 894–0508, or 2018 at 11:00 a.m. (EDT). The purpose this notice, including names and emailed Ana Victoria Fortes at afortes@ of the meeting is to review and vote on addresses when provided, will be a usccr.gov. Persons who desire a work product generated at the matter of public record. Comments will additional information may contact the Committee’s briefing on Predatory

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Lending. The Committee will also Agenda: Tuesday, April 3, 2018 at 11:00 Regional Office, U.S. Commission on discuss next steps for the predatory a.m. (EDT) Civil Rights, 300 North Los Angeles lending project. I. Welcome and Introductions Street, Suite 2010, Los Angeles, CA DATES: Tuesday, May 1, 2018, at 11:00 Rollcall 90012. They may be faxed to the a.m. (EDT). II. Planning Meeting Commission at (213) 894–0508, or Public Call-In Information: Review of Work Product on Predatory emailed Ana Victoria Fortes at afortes@ Conference call number: 1–888–334– Lending usccr.gov. Persons who desire 3020 and conference call ID: 8405258. Vote on Predatory Lending Work additional information may contact the FOR FURTHER INFORMATION CONTACT: Product Regional Programs Unit at (213) 894– Evelyn Bohor, at [email protected] or by Discuss Next Steps for Predatory 3437. phone at 202–376–7533. Lending Project Records and documents discussed during the meeting will be available for SUPPLEMENTARY INFORMATION: Interested III. Other Discussion members of the public may listen to the IV. Open Comment public viewing prior to and after the V. Adjournment discussion by calling the following toll- meeting at https://facadatabase.gov/ free conference call number: 1–888– Dated: April 12, 2018. committee/meetings.aspx?cid=270. 334–3020 and conference call ID: David Mussatt, Please click on the ‘‘Meeting Details’’ and ‘‘Documents’’ links. Records 8405258. Please be advised that before Supervisory Chief, Regional Programs Unit. placing them into the conference call, generated from this meeting may also be [FR Doc. 2018–08008 Filed 4–16–18; 8:45 am] inspected and reproduced at the the conference call operator may ask BILLING CODE P callers to provide their names, their Regional Programs Unit, as they become organizational affiliations (if any), and available, both before and after the email addresses (so that callers may be COMMISSION ON CIVIL RIGHTS meeting. Persons interested in the work notified of future meetings). Callers can of this Committee are directed to the expect to incur charges for calls they Notice of Public Meeting of the Oregon Commission’s website, https:// initiate over wireless lines, and the Advisory Committee to the U.S. www.usccr.gov, or may contact the Commission will not refund any Commission on Civil Rights Regional Programs Unit at the above incurred charges. Callers will incur no email or street address. AGENCY: U.S. Commission on Civil charge for calls they initiate over land- Rights. Agenda line connections to the toll-free ACTION: Announcement of meeting. Opening Remarks (2:00–2:10 p.m.) telephone number herein. Panel—Labor Trafficking in the Persons with hearing impairments SUMMARY: Notice is hereby given, Agriculture and Forestry Industries may also follow the discussion by first pursuant to the provisions of the rules (2:10–3:10 p.m.) calling the Federal Relay Service at 1– and regulations of the U.S. Commission • Reyna Lopez, Executive Director, 800–877–8339 and providing the on Civil Rights (Commission) and the Pineros y Campesinos Unidos del operator with the toll-free conference Federal Advisory Committee Act that Noroeste call number:1–888–334–3020 and the Oregon Advisory Committee • Carl Wilmsen, Executive Director, conference call ID: 8405258. (Committee) will hold a community Northwest Forest Worker Center Members of the public are invited to forum on Wednesday, May 2, 2018, • Joel Iboa, Chair, Governor’s submit written comments; the from 2:00 p.m.–5:00 p.m. PST for the Environmental Justice Task Force comments must be received in the purpose of hearing public testimony on Open Public Comment (3:20 p.m.–4:55 regional office approximately 30 days civil rights concerns of human and labor p.m.) after each scheduled meeting. Written trafficking in the sex, agriculture, and Dated: April 11, 2018. comments may be mailed to the Eastern forestry industries and equal protection Regional Office, U.S. Commission on David Mussatt, violations and discrimination based Supervisory Chief, Regional Programs Unit. Civil Rights, 1331 Pennsylvania upon race, national origin, religion, sex, [FR Doc. 2018–07898 Filed 4–16–18; 8:45 am] Avenue, Suite 1150, Washington, DC disability, and/or age of survivors. It 20425, or emailed to Evelyn Bohor at will also examine the effectiveness of BILLING CODE P [email protected]. Persons who desire state and local agency programs for additional information may contact the trafficking survivors. Eastern Regional Office at (202) 376– COMMISSION ON CIVIL RIGHTS DATES: The meeting will be held on 7533. Records and documents discussed Wednesday, May 2, 2018, at 2:00 p.m. Notice of Public Meeting of the West during the meeting will be available for PST to 5:00 p.m. PST. Virginia Advisory Committee ADDRESSES: Chemeketa Woodburn public viewing as they become available AGENCY: Commission on Civil Rights. Center, Room 110, 120 E Lincoln Street, at https://www.facadatabase.gov/ ACTION: Announcement of meeting. committee/meetings.aspx?cid=272; click Woodburn, OR 97071. the ‘‘Meeting Details’’ and ‘‘Documents’’ FOR FURTHER INFORMATION CONTACT: Ana SUMMARY: Notice is hereby given, links. Records generated from this Victoria Fortes (DFO) at afortes@ pursuant to the provisions of the rules meeting may also be inspected and usccr.gov or (213) 894–3437. and regulations of the U.S. Commission reproduced at the Eastern Regional SUPPLEMENTARY INFORMATION: Members on Civil Rights (Commission), and the Office, as they become available, both of the public are entitled to make Federal Advisory Committee Act before and after the meetings. Persons comments during the open comment (FACA) that a briefing meeting of the interested in the work of this advisory periods. Members of the public may also West Virginia Advisory Committee to committee are advised to go to the submit written comments; the the Commission will convene by Commission’s website, www.usccr.gov, comments must be received in the conference call at 12:00 p.m. (EST) on or to contact the Eastern Regional Office Regional Programs Unit within 30 days Friday, May 4, 2018. The purpose of the at the above phone number, email or following the meeting. Written meeting is hear presentations from a street address. comments may be mailed to the Western panel of experts who will provide a

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national perspective on the impact a at the above phone numbers, email or emailed to Evelyn Bohor at ero@ felony conviction/record has on persons street address. usccr.gov. Persons who desire access to employment, housing additional information may contact the Agenda: Friday, May 4, 2018, at 12:00 occupational licenses and public Eastern Regional Office at 202–376– p.m. (EDT) benefits. 7533. I. Rollcall DATES: Friday, May 4, 2018, at 12:00 Records and documents discussed p.m. (EDT). II. Welcome and Introductions during the meeting will be available for III. Panel Presentation public viewing as they become available FOR FURTHER INFORMATION CONTACT: Ivy IV. Adjourn Davis at [email protected] or by phone at at http://facadatabase.gov/committee/ 202–376–7533. Dated: April 11, 2018. meetings.aspx?cid=241; click the ‘‘Meeting Details’’ and ‘‘Documents’’ SUPPLEMENTARY INFORMATION: Public David Mussatt, links. Records generated from this Call-In Information: Conference call-in Supervisory Chief, Regional Programs Unit. meeting may also be inspected and number: 1–800–474–8920 and [FR Doc. 2018–07896 Filed 4–16–18; 8:45 am] reproduced at the Eastern Regional conference call number: 8310490. BILLING CODE P Interested members of the public may Office, as they become available, both listen to the discussion by calling the before and after the meeting. Persons following toll-free conference call-in COMMISSION ON CIVIL RIGHTS interested in the work of this advisory number: 1–800–474–8920 and committee are advised to go to the conference call number: 8310490. Please Agenda and Notice of Public Meeting Commission’s website, www.usccr.gov, be advised that before being placed into of the District of Columbia Advisory or to contact the Eastern Regional Office the conference call, the conference call Committee at the above phone numbers, email or street address. operator will ask callers to provide their AGENCY: Commission on Civil Rights. names, their organizational affiliations ACTION: Announcement of monthly Agenda (if any), and email addresses (so that planning meeting. callers may be notified of future Tuesday, May 8, 2018 at 11:30 a.m. meetings). Callers may incur charges for SUMMARY: Notice is hereby given, I. Rollcall calls they initiate over wireless lines, pursuant to the provisions of the rules II. Welcome and Introductions and the Commission will not refund any and regulations of the U.S. Commission III. Discuss Project Planning incurred charges. Callers will incur no on Civil Rights (Commission), and the IV. Other Business charges for calls they initiate over land- Federal Advisory Committee Act V. Adjourn line connections to the toll-free (FACA), that a planning meeting of the Dated: April 11, 2018. conference call-in number. District of Columbia Advisory David Mussatt, Persons with hearing impairments Committee to the Commission will Chief, Regional Programs Unit. may also follow the discussion by first convene at 11:30 a.m. (EDT) Tuesday, calling the Federal Relay Service at 1– May 8, 2018 at the offices of the U.S. [FR Doc. 2018–07895 Filed 4–16–18; 8:45 am] 888–364–3109 and providing the Commission on Civil Rights, 1331 BILLING CODE P operator with the toll-free conference Pennsylvania Avenue NW, Suite 1150, call-in number: 1–800–474–8920 and Washington, DC 20425. The purpose of conference call number: 8310490. the planning meeting is to continue DEPARTMENT OF COMMERCE Members of the public are entitled to project planning. This fall the submit written comments. The Committee will conduct a briefing International Trade Administration comments must be received in the meeting on its civil rights project, which regional office approximately 30 days examines the treatment of homeless after each scheduled meeting. Written persons that get swept up in the DC [C–570–968] comments may be mailed to the Eastern criminal justice system, including a Aluminum Extrusions From the Regional Office, U.S. Commission on review of the DC Mental Health Court. Civil Rights, 1331 Pennsylvania People’s Republic of China: Correction DATES: May 8, 2018 at 11:30 a.m. (EDT). Avenue, Suite 1150, Washington, DC of Notification of Rescission, in Part; 20425, or emailed to Corrine Sanders at ADDRESSES: 1331 Pennsylvania Avenue 2016 NW, Suite 1150, Washington, DC 20425. [email protected]. Persons who desire AGENCY: Enforcement and Compliance, FOR FURTHER INFORMATION CONTACT: Ivy additional information may contact the International Trade Administration, L. Davis, at [email protected] or by phone Eastern Regional Office at (202) 376– Department of Commerce. 7533. at 202–376–7533. FOR FURTHER INFORMATION CONTACT: Records and documents discussed SUPPLEMENTARY INFORMATION: Persons during the meeting will be available for with accessibility needs should contact Davina Friedmann or Tom Bellhouse, public viewing as they become available the Eastern Regional Office no later than AD/CVD Operations, Office VI, at https://database.faca.gov/committee/ 10 working days before the scheduled Enforcement and Compliance, meetings.aspx?cid=279, click the meeting by sending an email to the International Trade Administration, ‘‘Meeting Details’’ and ‘‘Documents’’ following email address at ero@ U.S. Department of Commerce, 1401 links. Records generated from this usccr.gov. Constitution Avenue NW, Washington, meeting may also be inspected and Members of the public are entitled to DC 20230; telephone: (202) 482–0698 or reproduced at the Eastern Regional submit written comments. The (202) 482–2057, respectively. Office, as they become available, both comments must be received in the SUPPLEMENTARY INFORMATION: On March before and after the meetings. Persons regional office by Friday, June 8, 2018. 15, 2018, the Department of Commerce interested in the work of this advisory Comments may be mailed to the Eastern (Commerce) published the Preliminary committee are advised to go to the Regional Office, U.S. Commission on Results in the 2016 countervailing duty Commission’s website, www.usccr.gov, Civil Rights, 1331 Pennsylvania Avenue administrative review of aluminum or to contact the Eastern Regional Office Suite 1150, Washington, DC 20425 or extrusions from the People’s Republic of

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China.1 In that notice, Commerce Additionally, we determine that CLC (the petitioners), the mandatory AR incorrectly listed Guangdong Xin Wei Guizhou Tyre Co., Ltd. and its affiliate respondents Weihai Zhongwei Rubber Aluminum Products Co., Ltd. among the are ineligible for separate rate status. Co., Ltd. (Zhongwei) and GTC,4 companies for which it was rescinding Finally, the new shipper review with interested party Valmont Industries Inc., the administrative review.2 Commerce respect to The Carlstar Group LLC, the and NSR respondent Carlstar.5 We intended for Guangdong Xin Wei producer Carlisle (Meizhou) Rubber received rebuttal briefs from the Aluminum Products Co., Ltd. to only be Manufacturing Co., Ltd., and its petitioners, Zhongwei, and Carlstar. For listed in the ‘‘Intent to Rescind affiliated exporter CTP HK has been a further discussion of the events that Administrative Review, In Part’’ section rescinded. occurred in this investigation of the Preliminary Results, rather than subsequent to the Preliminary Results, DATES: Applicable: April 17, 2018. in Appendix II.3 see the Issues and Decision This notice serves as a correction that FOR FURTHER INFORMATION CONTACT: Alex Memorandum.6 we have not rescinded this Rosen AD/CVD Operations, Office III, administrative review with respect to Enforcement and Compliance, Scope of the Order Guangdong Xin Wei Aluminum International Trade Administration, The merchandise covered by this Products Co., Ltd. Rather, we U.S. Department of Commerce, 1401 order includes new pneumatic tires preliminarily intend to rescind the Constitution Avenue NW, Washington, designed for off-the-road and off- review with respect to Guangdong Xin DC 20230; telephone (202) 482–7814. highway use, subject to certain Wei Aluminum Products Co., Ltd., SUPPLEMENTARY INFORMATION: exceptions. The subject merchandise is because there is no evidence on the currently classifiable under Harmonized Background record to indicate that it had entries of Tariff Schedule of the United States subject merchandise during the period On October 10, 2017, Commerce (HTSUS) subheadings: 4011.20.10.25, of review. As stated in the Preliminary published its Preliminary Results of the 4011.20.10.35, 4011.20.50.30, Results, a final decision regarding antidumping duty administrative review 4011.20.50.50, 4011.61.00.00, whether to rescind the review of this (AR) and new shipper review (NSR).1 4011.62.00.00, 4011.63.00.00, company will be issued with the final On December 11, 2017, in accordance 4011.69.00.00, 4011.92.00.00, results of review. with section 751(a)(3)(A) of the Tariff 4011.93.40.00, 4011.93.80.00, Dated: April 11, 2018. Act of 1930, as amended (the Act), 4011.94.40.00, and 4011.94.80.00. The Commerce extended the period for HTSUS subheadings are provided for Gary Taverman, issuing the final results of this review by convenience and customs purposes Deputy Assistant Secretary for Antidumping 2 only; the written product description of and Countervailing Duty Operations, 60 days, to April 9, 2018. On January performing the non-exclusive functions and 23, 2018, Commerce exercised its the scope of the order is dispositive. For duties of the Assistant Secretary for discretion to toll all deadlines affected a complete description of the scope of Enforcement and Compliance. by for the duration of the closure of the the order, see the Issues and Decision [FR Doc. 2018–07992 Filed 4–16–18; 8:45 am] Federal Government from January 20 Memorandum. through 22, 2018. As a result, the period BILLING CODE 3510–DS–P1 Analysis of Comments Received for issuing the final results of this review by Commerce has been extended All issues raised in the case and DEPARTMENT OF COMMERCE to April 11, 2018.3 rebuttal briefs filed by parties in this In accordance with 19 CFR 351.309, review are addressed in the Issues and International Trade Administration we invited interested parties to Decision Memorandum, which is hereby [A–570–912] comment on the Preliminary Results, as well as information provided to the 4 In the initial investigation, Commerce collapsed Guizhou Tyre Co., Ltd. and Guizhou Tyre Import Certain New Pneumatic Off-the-Road record subsequently. We received case and Export Corporation (GTCIE) into a single entity, Tires From the People’s Republic of briefs from The United Steel, Paper and see Certain New Pneumatic Off-The-Road Tires China: Final Results of Antidumping Forestry, Rubber, Manufacturing, From the People’s Republic of China; Preliminary Duty Administrative Review and New Energy, Allied Industrial and Service Determination of Sales at Less Than Fair Value and Postponement of Final Determination, 73 FR 9278, Shipper Review; 2015–2016 Workers International Union, AFL–CIO– 9283 (February 20, 2008), unchanged in Certain New Pneumatic Off-The-Road Tires from the AGENCY: Enforcement and Compliance, 1 See Certain New Pneumatic Off-the-Road Tires People’s Republic of China: Final Affirmative International Trade Administration, From the People’s Republic of China: Preliminary Determination of Sales at Less Than Fair Value and Department of Commerce. Results of Antidumping Duty Administrative Partial Affirmative Determination of Critical Review and Preliminary Rescission of New Shipper Circumstances, 73 FR 40485 (July 15, 2008). This SUMMARY : The Department of Commerce Review; 2015–2016, 82 FR 46965 (October 10, 2017) decision is unchallenged in the instant review; (Commerce) determines that Weihai (Preliminary Results) and accompanying ‘‘Decision thus, Commerce continues to treat GTC and GTCIE Zhongwei Rubber Co., Ltd., a Memorandum for Preliminary Results of the as a single entity (collectively, GTC). manufacturer/exporter of certain new Antidumping Duty Administrative Review and 5 The NSR was requested by Carlstar Group LLC pneumatic off-the-road tires (OTR tires) Preliminary Recession of New Shipper Review: (formerly dba CTP Transportation Products) Certain New Pneumatic Off-the-Road Tires from the (Carlstar Group), a U.S. producer, importer and from the People’s Republic of China People’s Republic of China; 2015–2016,’’ dated seller of subject merchandise; concerning (China), sold subject merchandise in the October 2, 2017 (Preliminary Decision merchandise produced by Carlisle (Meizhou) United States at prices below normal Memorandum). Rubber Manufacturing Co., Ltd. (Carlisle Meizhou), value during the period of review (POR). 2 See memorandum, ‘‘Certain New Pneumatic Off- its affiliated producer of OTR tires from China, and the-Road Tires from the People’s Republic of China: exported by CTP Distribution (HK) Limited (CTP Extension of Deadline for Final Results of HK), an affiliated trading company located in Hong 1 See Aluminum Extrusions from the People’s Antidumping Duty Administrative Review and New Kong (collectively, Carlstar). Republic of China: Preliminary Results of Shipper Review; 2015–2016,’’ dated December 11, 6 See memorandum, ‘‘Issues and Decision Countervailing Duty Administrative Review, 2017. Memorandum for Final Results of Antidumping Rescission of Review, in Part, and Intent to Rescind, 3 See memorandum, ‘‘Deadlines Affected by the Duty Administrative Review and New Shipper in Part; 2016, 83 FR 11501 (March 15, 2018) Shutdown of the Federal Government’’ (Tolling Review: Certain New Pneumatic Off-the-Road Tires (Preliminary Results), Memorandum), dated January 23, 2018. All from the People’s Republic of China; 2015–2016,’’ 2 Id., 83 FR at Appendix II. deadlines in this segment of the proceeding have adopted by and dated concurrently with this notice 3 Id., 83 FR at 11502. been extended by 3 days. (Issues and Decision Memorandum).

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adopted by this notice. A list of the Qihang Tyre Co. Ltd. (Qihang) and available.10 In this review, we have issues that parties raised and to which Shandong Zhentai Group Co., Ltd. calculated a weighted-average dumping we responded in the Issues and (Zhentai), were eligible for separate-rate margin for Zhongwei that is above de Decision Memorandum is attached in status. We also preliminarily minimis and not based entirely on facts the Appendix to this notice. The Issues determined that GTC, as well as available. Therefore, consistent with and Decision Memorandum is a public separate rate applicant Cheng Shin Commerce’s practice, we have assigned document and is on file electronically Rubber Industry Ltd. (Cheng Shin), and to Qihang and Zhentai the weighted- via Enforcement and Compliance’s non-responsive respondent Qingdao average dumping margin calculated for Antidumping and Countervailing Duty Milestone Tyres Co. Ltd. (Milestone), Zhongwei as the separate rate for this Centralized Electronic Service System were not eligible for a separate rate, and review. (ACCESS). ACCESS is available to are, thus, part of the China-wide entity.8 Changes Since the Preliminary Results registered users at http:// We received no information since the access.trade.gov and it is available to all issuance of the Preliminary Results that Based on an analysis of the comments parties in the Central Records Unit, provides a basis for reconsidering these received, we made certain calculation room B8024 of the main Department of determinations, therefore, for the final changes and revisions to the valuation Commerce building. In addition, a results we continue to find that of certain factors of production since the complete version of the Issues and Zhongwei, Qihang, and Zhentai are Preliminary Results with respect to Decision Memorandum can be accessed eligible for separate rates and that GTC, Zhongwei’s margin calculation. For directly on the internet at http:// Cheng Shin, and Milestone are further details on the changes made enforcement.trade.gov/frn/index.html. ineligible for separate rates. since the Preliminary Results, see the The signed Issues and Decision Additionally, as a result of Commerce’s Issues and Decision Memorandum.11 Memorandum and electronic version of rescission of the new shipper review In light of changes made since the the Issues and Decision Memorandum with respect to Carlstar, and because Preliminary Results which altered are identical in content. Carlstar did not submit a separate rate Zhongwei’s margin, we have updated Recession of the New Shipper Review application in the administrative the separate rate that assigned to Qihang review, it has not been granted a and Zhentai. In accordance with 19 CFR separate rate. For further discussion, see 351.214(c), an exporter or producer may Issues and Decision Memorandum at Final Results of Review request an NSR within one year of the Comments 1 and 2. date on which subject merchandise was As a result of this administrative first entered, or withdrawn from Rate for Non-Individually-Examined review, we determine that the following warehouse, for consumption, or, if the Separate Rate Companies weighted-average dumping margins exporter or producer cannot establish The statute and Commerce’s exist for the period September 1, 2015, the date of the first entry, then the date regulations do not address the through August 31, 2016: on which it first shipped the establishment of a rate to be assigned to merchandise for export to the United Weighted- respondents not selected for individual average States. examination when Commerce limits its Exporter dumping As discussed in the Issues and examination of companies subject to the margin Decision Memorandum and NSR administrative review pursuant to (percent) Rescission Memorandum, Commerce section 777A(c)(2)(B) of the Act. Weihai Zhongwei Rubber Co., finds that Carlstar’s request for a new Generally, Commerce looks to section shipper review was not timely filed Ltd ...... 11.87 735(c)(5) of the Act, which provides Qingdao Qihang Tyre Co. Ltd .... 11.87 within one year of the date the subject instructions for calculating the all- Shandong Zhentai Group Co., merchandise produced and exported by others rate in an investigation, for Ltd ...... 11.87 Carlstar’s predecessor was first entered guidance when calculating the rate for into the United States, pursuant to 19 respondents not individually examined Additionally, as in the Preliminary CFR 351.214(c).7 As a result, we in an administrative review. Section Results, Commerce determines that determine that Carlstar’s request did not 735(c)(5)(A) of the Act articulates a GTC, Cheng Shin, and Milestone, are meet the requirements of 19 CFR preference for not calculating an all- part of the China-wide entity. 351.214(c), and are rescinding the new others rate using rates which are zero, shipper review for Carlstar. Because de minimis, or based entirely on facts 10 See, e.g., Preliminary Determination of Sales at much of the factual information used in 9 available. Accordingly, Commerce’s Less Than Fair Value and Partial Affirmative our analysis involves business usual practice has been to determine the Determination of Critical Circumstances: Certain proprietary information, a full dumping margin for companies not Polyester Staple Fiber from the People’s Republic of discussion of the basis for our individually examined by averaging the China, 71 FR 77373, 77377 (December 26, 2006), determination is set forth in the NSR unchanged in Final Determination of Sales at Less weighted-average dumping margins for Than Fair Value and Partial Affirmative Rescission Memorandum. the individually examined respondents, Determination of Critical Circumstances: Certain Separate Rates excluding rates that are zero, de Polyester Staple Fiber from the People’s Republic of minimis, or based entirely on facts China, 72 FR 19690 (April 19, 2007). In the Preliminary Results, we 11 See also, memorandum, ‘‘Final Results of the determined that Zhongwei, as well as 2015–2016 Administrative Review of the 8 See Preliminary Results, 82 FR at 46966, and Antidumping Duty Order on Certain New two separate rate applicants, Qingdao accompanying PDM at the ‘‘Separate Rate Analysis’’ Pneumatic Off-The-Road Tires from the People’s section. Republic of China: Surrogate Value Memorandum,’’ 7 See memorandum, ‘‘New Pneumatic Off-the- 9 See Ball Bearings and Parts Thereof from dated concurrently with this notice, and Road Tires from the People’s Republic of China: France, Germany, Italy, Japan, and the United memorandum, ‘‘2015–2016 Administrative Review Final Analysis of Comments Regarding the Kingdom: Final Results of Antidumping Duty of the Antidumping Duty Order on Certain New Determination to Rescind the New Shipper Administrative Reviews and Rescission of Reviews Pneumatic Off-the-Road Tires from the People’s Review,’’ dated concurrently with this in Part, 73 FR 52823, 52824 (September 11, 2008), Republic of China: Analysis of the Final Results memorandum (NSR Final Rescission and accompanying Issues and Decision Margin Calculation for Weihai Zhongwei Rubber Memorandum). Memorandum at Comment 16. Co., Ltd.,’’ dated concurrently with this notice.

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Disclosure Pursuant to a refinement in Commerce’s Because we did not calculate a We intend to disclose the calculations non-market economy (NME) practice, dumping margin for Carlstar or grant performed regarding these final results for entries that were not reported in the Carlstar a separate rate in this new within five days of the date of U.S. sales databases submitted by shipper review, as noted above, we find publication of this notice to parties in companies individually examined that Carlstar continues to be part of the this proceeding, in accordance with 19 during this review, Commerce will China-wide entity. The cash deposit rate CFR 351.224(b). instruct CBP to liquidate such entries at for the China-wide entity is 105.31 the China-wide rate.17 In addition, if percent. These cash deposit Assessment Rates Commerce determines that an exporter requirements shall remain in effect until Commerce shall determine, and CBP under review had no shipments of further notice. subject merchandise, any suspended shall assess, antidumping duties on all Notification to Importers appropriate entries covered by this entries that entered under that review pursuant to section 751(a)(2)(C) exporter’s case number (i.e., at that This notice serves as a final reminder of the Act and 19 CFR 351.212(b)(1).12 exporter’s rate) will be liquidated at the to importers of their responsibility Commerce intends to issue assessment China-wide rate. under 19 CFR 351.402(f)(2) to file a instructions directly to CBP 15 days Because we are rescinding the new certificate regarding the reimbursement after the date of publication of these shipper review of Carlstar, we have not of antidumping and/or countervailing final results of administrative review. made a determination as to whether duties prior to liquidation of the For Zhongwei, Commerce will Carlstar qualifies for a separate rate. relevant entries during this review calculate importer-specific assessment Therefore, Carlstar will remain part of period. Failure to comply with this rates on the basis of the ratio of the total the China-wide entity and, accordingly, requirement could result in the amount of dumping calculated for the any entries covered by this new shipper Secretary’s presumption that importer’s examined sales to the total review will be assessed at the China- reimbursement of the antidumping and/ entered value of sales, in accordance wide rate. or countervailing duties occurred and with 19 CFR 351.212(b)(1). For the subsequent assessment of double Cash Deposit Requirements customers or importers of Zhongwei for antidumping duties. which we do not have entered values, The following cash deposit Administrative Protective Order we calculated importer- (or customer-) requirements will be effective for all This notice also serves as a reminder specific antidumping duty assessment shipments of the subject merchandise to parties subject to administrative amounts based on the ratio of the total entered, or withdrawn from warehouse, protective order (APO) of their amount of dumping duties calculated for consumption on or after the responsibility concerning the return or for the examined sales of subject publication date of the final results of destruction of proprietary information merchandise to the total sales quantity this administrative review, as provided disclosed under the APO in accordance of those same sales.13 For customers or by section 751(a)(2)(C) of the Act: (1) with 19 CFR 351.305(a)(3), which importers of Zhongwei for which we For the exporters listed above, the cash continues to govern business received entered-value information, we deposit rate will be equal to the proprietary information in this segment have calculated importer- (or customer- weighted-average dumping margin of the proceeding. Timely written ) specific antidumping duty assessment identified in the ‘‘Final Results’’ section notification of the return/destruction of rates based on importer- (or customer-) of this notice, above; (2) for previously APO materials or conversion to judicial specific ad valorem rates.14 Where an investigated or reviewed Chinese and protective order is hereby requested. importer- or (customer-) specific ad non-Chinese exporters that are not Failure to comply with the regulations valorem rate is greater than de minimis, under review in this segment of the and terms of an APO is a violation Commerce will instruct CBP to collect proceeding but that received a separate which is subject to sanction. the appropriate duties at the time of rate in a previous segment, the cash We are issuing and publishing these liquidation.15 deposit rate will continue to be the final results of administrative review in For the non-examined separate rate exporter-specific rate (or exporter- accordance with sections 751(a)(1) and companies, we will instruct CBP to producer chain rate) published for the 777(i) of the Act. liquidate all appropriate entries at 11.87 most recently completed segment of this percent, which is equal to the weighted- proceeding in which the exporter was Dated: April 11, 2018. average dumping margin assigned to reviewed; (3) for all Chinese exporters of Gary Taverman, Zhongwei. subject merchandise which have not Deputy Assistant Secretary for Antidumping For those entities that are subject to been found to be entitled to a separate and Countervailing Duty Operations, this review that Commerce has rate, the cash deposit rate will be the performing the non-exclusive functions and determined are part of the China-wide China-wide rate of 105.31 percent; and duties of the Assistant Secretary for entity (i.e., GTC, Cheng Shin and (4) for all non-China exporters of subject Enforcement and Compliance. Milestone), we will instruct CBP to merchandise which have not received Appendix—Issues and Decision liquidate all appropriate entries at the their own rate, the cash deposit rate will Memorandum China-wide rate of 105.31 percent.16 be the rate applicable to the China I. Summary exporter(s) that supplied that non-China 12 II. Background See Antidumping Proceeding: Calculation of exporter. These cash deposit III. Scope of the Order the Weighted-Average Dumping Margin and Assessment Rate in Certain Antidumping Duty requirements, when imposed, shall IV. Changes since the Preliminary Results Proceedings; Final Modification, 77 FR 8103 remain in effect until further notice. V. Discussion of the Issues (February 14, 2012) (NME Antidumping Comment 1: Carlstar’s Eligibility for a New Proceedings). People’s Republic of China: Final Results of Shipper Review (NSR) 13 See 19 CFR 351.212(b)(1). Antidumping Duty Administrative Review; 2012– Comment 2: GTC’s Separate Rate Eligibility 14 Id. 2013, 80 FR 20197 (April 15, 2015). A. The Statutory Authority to Issue a 15 See 19 CFR 351.212(b)(1). 17 See Non-Market Economy Antidumping Country-Wide Rate 16 The China-wide rate was determined in Certain Proceedings: Assessment of Antidumping Duties, 76 B. The Presumption of Chinese New Pneumatic Off-the-Road Tires from the FR 65694 (October 24, 2011). Government Control

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C. The Government Control of GTC’s December 8, 2017, Commerce received merchandise is currently classifiable Export Activities timely filed case briefs from Deacero, under the Harmonized Tariff Schedule D. WTO Obligations and Nucor Corporation (Nucor).2 On of the United States (HTSUS) E. A New China-Wide Rate Applicable to December 20, 2017, Commerce received subheadings: 7213.91.3000, GTC F. Adjustments for Domestic and Export timely filed rebuttal briefs from both 7213.91.3010, 7213.91.3011, Subsidies Found in the Parallel CVD Deacero and Nucor. 7213.91.3015, 7213.91.3020, Review Commerce has exercised its discretion 7213.91.3090, 7213.91.3091, Comment 3: Surrogate Value for Mixed to toll all deadlines affected by the 7213.91.3092, 7213.91.3093, Rubber duration of the closure of the Federal 7213.91.4500, 7213.91.4510, Comment 4: Overhead and Selling, General Government from January 20 through 7213.91.4590, 7213.91.6000, and Administrative Expenses (SG&A) 22, 2018.3 Additionally, on February 27, 7213.91.6010, 7213.91.6090, Ratios Used to Calculate Zhongwei’s 2018, Commerce postponed the final Margin 7213.99.0030, 7213.99.0031, results of this review by 30 days until 7213.99.0038, 7213.99.0090, Comment 5: CVD Rates Used to Calculate 4 April 11, 2018. 7227.20.0000, 7227.20.0010, Double-Remedies Adjustment for Based on an analysis of the comments Zhongwei 7227.20.0020, 7227.20.0030, Comment 6: Irrecoverable Value-Added received, Commerce has made changes 7227.20.0080, 7227.20.0090, Tax (VAT) Rate for Zhongwei to the calculated weighted-average 7227.20.0095, 7227.90.6010, VI. Recommendation dumping margin determined for 7227.90.6020, 7227.90.6030, Deacero. Commerce has listed the final [FR Doc. 2018–07991 Filed 4–16–18; 8:45 am] 7227.90.6035, 7227.90.6050, calculated weighted-average dumping BILLING CODE P 7227.90.6051, 7227.90.6053, margin in the ‘‘Final Results of 7227.90.6058, 7227.90.6059, Administrative Review’’ section below. 7227.90.6080, and 7227.90.6085. The DEPARTMENT OF COMMERCE Scope of the Order 5 HTSUS subheadings are provided for convenience and customs purposes International Trade Administration The product covered by the order is wire rod, in coils, of approximately only; the written product description [A–201–830] round cross section, 5.00 mm or more, remains dispositive. but less than 19.00 mm, in solid cross- Analysis of Comments Received Carbon and Certain Alloy Steel Wire sectional diameter.6 The subject Rod From Mexico: Final Results of Commerce has addressed the issues Antidumping Duty Administrative 2 See Deacero’s Case Brief, ‘‘Carbon and Certain raised by Deacero and Nucor in their Review and Final Determination of No Alloy Steel Wire Rod from Mexico—Case Brief,’’ case and rebuttal briefs in the Issues and Shipments; 2015–2016 dated December 8, 2017 (Deacero’s Case Brief); the Nucor’s Case Brief, ‘‘Carbon and Certain Alloy Steel Decision Memorandum. Commerce has AGENCY: Enforcement and Compliance, Wire Rod from Mexico: Case Brief,’’ dated identified and listed these issues in the International Trade Administration, December 8, 2017 (Nucor’s Case Brief). Appendix to this notice. Because the 3 See Memorandum for The Record from Issues and Decision Memorandum is a Department of Commerce. Christian Marsh, Deputy Assistant Secretary for SUMMARY: The Department of Commerce Enforcement and Compliance, performing the non- public document, parties can find a (Commerce) finds that Deacero S.A.P.I. exclusive functions and duties of the Assistant complete discussion of these issues and de C.V. (Deacero), a producer and Secretary for Enforcement and Compliance, the corresponding recommendations ‘‘Deadlines Affected by the Shutdown of the filed electronically via Enforcement and exporter of carbon and certain alloy Federal Government’’ (Tolling Memorandum), steel wire rod (wire rod) from Mexico, dated January 23, 2018. All deadlines in this Compliance’s Antidumping and made sales of subject merchandise at segment of the proceeding affected by the closure Countervailing Duty Centralized of the Federal Government have been extended by less than normal value (NV) during the Electronic Service System (ACCESS). 3 days. ACCESS is available to registered users period of review (POR), October 1, 2015, 4 See Commerce Letter re: Carbon and Certain through September 30, 2016. We also Alloy Steel Wire Rod from Mexico: Extension of at https://access.trade.gov and in the find that ArcelorMittal las Truchas, S.A. Deadline for Final Results of Antidumping Duty Central Records Unit, room B8024 of the Administrative Review; 2015–2016, dated February de C.V. (AMLT) made no shipments of main Department of Commerce 27, 2018. building. Additionally, parties can subject merchandise during the POR. 5 For the full text of the scope of the order, see DATES: Applicable April 17, 2018. Memorandum, ‘‘Issues and Decision Memorandum access a complete version of the Issues for the Final Results of the 2015–2016 Antidumping and Decision Memorandum directly on FOR FURTHER INFORMATION CONTACT: Duty Administrative Review: Carbon and Certain the internet at http://trade.gov/ Keith Haynes, AD/CVD Operations, Alloy Steel Wire Rod from Mexico,’’ dated enforcement/frn/index.html. The signed Office III, Enforcement and Compliance, concurrently with this determination and hereby Issues and Decision Memorandum and International Trade Administration, adopted by this notice (Issues and Decision Memorandum). electronic versions of the Issues and U.S. Department of Commerce, 1401 6 On October 1, 2012, Commerce determined that Decision Memorandum are identical in Constitution Avenue NW, Washington, Deacero’s shipments to the United States of narrow content. DC 20230; telephone: (202) 482–5139. gauge wire rod (4.75 mm to 5.00 mm) (narrow gauge wire rod) constitute merchandise altered in form or SUPPLEMENTARY INFORMATION: appearance in such minor respects that it should be Changes Since the Preliminary Results included within the scope of the order on wire rod Background from Mexico. See Carbon and Certain Alloy Steel Based on the case brief and rebuttal Commerce published the preliminary Wire Rod from Mexico: Affirmative Final comments received from Deacero and Determination of Circumvention of the Nucor, we made changes to our rate results of this administrative review of Antidumping Order, 77 FR 59892 (October 1, 2012) wire rod from Mexico on November 8, and accompanying Issues and Decision calculation for Deacero. For a discussion 2017.1 We invited interested parties to Memorandum. The U.S. Court of Appeals for the of these issues, see the Issues and comment on the Preliminary Results. On Federal Circuit upheld this determination. See Decision Memorandum. Deacero S.A. de C.V. v. United States, 817 F.3d 1332, 1339 (Fed. Cir. 2016). Because there were no Final Determination of No Shipments 1 See Carbon and Certain Alloy Steel Wire Rod changes to the facts which supported that decision from Mexico: Preliminary Results and Preliminary since that determination, we continue to find In the Preliminary Results, we Determination of No Shipments; 2015–2016, 82 FR Deacero’s narrow gauge wire rod (4.75 mm to 5.00 51819 (November 8, 2017) (Preliminary Results). mm) subject merchandise. preliminarily found that AMLT had no

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shipments during the POR.7 Because importer-specific assessment rate is zero information disclosed under APO in there has not been any contradictory or de minimis. accordance with 19 CFR 351.305(a)(3), information added to the record of this As noted in the ‘‘Final Determination which continues to govern business review since the Preliminary Results, of No Shipments’’ section, above, proprietary information in this segment based on record evidence, Commerce Commerce will instruct CBP to liquidate of proceeding. Timely written continues to find that AMLT did not any existing entries of merchandise notification of the return/destruction of ship subject merchandise during the produced by AMLT but exported by APO materials or conversion to judicial POR. Accordingly, consistent with other parties, at the rate for the protective order is hereby requested. Commerce’s practice, we intend to intermediate reseller, if available, or at Failure to comply with the regulations instruct U.S. Customs and Border the all-others rate. and terms of an APO is a violation Protection (CBP) to liquidate any The following cash deposit which is subject to sanction. existing entries of subject merchandise requirements will be effective upon These final results are issued and made during the POR that were publication of the notice of final results published in accordance with sections produced by AMLT, but exported by of administrative review for all 751(a)(1) and 777(i)(1) of the Act. shipments of subject merchandise other parties without their own rate, at Dated: April 11, 2018. the all-others rate effective during the entered, or withdrawn from warehouse, Gary Taverman, POR.8 for consumption on or after the publication of the final results of this Deputy Assistant Secretary for Antidumping Final Results of Administrative Review administrative review, as provided by and Countervailing Duty Operations, performing the non-exclusive functions and Commerce finds that the following section 751(a)(2) of the Act: (1) The cash deposit rate for Deacero will be the rate duties of the Assistant Secretary for estimated weighted-average dumping Enforcement and Compliance. margin exists during the POR, as established in the final results of this referenced below: administrative review; (2) for Appendix—Issues and Decision merchandise exported by producers or Memorandum Weighted- exporters not covered in this I. Summary average administrative review but covered in a II. Background Producer/exporter dumping prior segment of the proceeding, the margin III. Scope of the Order (percent) cash deposit rate will continue to be the IV. Analysis of Comments company-specific rate published for the Comment 1: Whether Deacero’s Reported Deacero S.A.P.I. de C.V ...... 12.57 most recent period; (3) if the exporter is Billet Cost Data Are Reliable not a firm covered in this review, a prior Comment 2: Whether to Cap Deacero’s Assessment and Cash Deposit review, or the original investigation, but Freight Revenue by its Freight Cost Comment 3: Whether to Rely on a Different Requirements the producer is, the cash deposit rate will be the rate established for the most Cost of Production (COP) Database In accordance with 19 CFR Comment 4: Treatment of Certain Mixed recent period for the producer of the 351.212(b)(1), Commerce intends to Currency Variables Within the Margin merchandise; and (4) the cash deposit Program issue appropriate instructions to CBP 41 rate for all other producer or exporters days after publication of the final results Comment 5: Treatment of Certain 9 will continue to be 20.11 percent, the Commissions Within the Margin of this review. all-others rate established in the For Deacero, because its weighted- Program investigation.10 These cash deposit V. Recommendation average dumping margin is not zero or requirements, when imposed, shall [FR Doc. 2018–07993 Filed 4–16–18; 8:45 am] de minimis (i.e., less than 0.5 percent), remain in effect until further notice. Commerce has calculated importer- BILLING CODE 3510–DS–P specific antidumping duty assessment Notification to Importers rates. We calculated importer-specific This notice also serves as a final DEPARTMENT OF COMMERCE ad valorem antidumping duty reminder to importers of their assessment rates by aggregating the total responsibility under 19 CFR United States Patent and Trademark amount of dumping calculated for the 351.402(f)(2) to file a certificate Office examined sales of each importer and regarding the reimbursement of dividing each of these amounts by the antidumping duties prior to liquidation Submission for OMB Review; total entered value associated with those of the relevant entries during this POR. Comment Request; ‘‘Public Key sales. We will instruct CBP to assess Failure to comply with this requirement Infrastructure (PKI) Certificate Action antidumping duties on all appropriate could result in Commerce’s Form’’ entries covered by this review where an presumption that reimbursement of importer-specific assessment rate is not antidumping duties has occurred and The United States Patent and zero or de minimis. Pursuant to 19 CFR the subsequent assessment of doubled Trademark Office (USPTO) will submit 351.106(c)(2), we will instruct CBP to antidumping duties. to the Office of Management and Budget liquidate without regard to antidumping (OMB) for clearance the following duties any entries for which the Administrative Protective Order proposals for collection of information This notice also serves as a final under the provisions of the Paperwork 7 See Preliminary Results, 82 FR at 51819–20. reminder to parties subject to an Reduction Act (44 U.S.C. Chapter 35). 8 See, e.g., Magnesium Metal from the Russian administrative protective order (APO) of Agency: United States Patent and Federation: Preliminary Results of Antidumping their responsibility concerning the Trademark Office, Commerce. Duty Administrative Review, 75 FR 26922, 26923 Title: Public Key Infrastructure (PKI) (May 13, 2010), unchanged in Magnesium Metal return or destruction of proprietary from the Russian Federation: Final Results of Certificate Action Form. Antidumping Duty Administrative Review, 75 FR 10 See Notice of Antidumping Duty Orders: OMB Control Number: 0651–0045. 56989 (September 17, 2010). See also Antidumping Carbon and Certain Alloy Steel Wire Rod from Form Number(s): and Countervailing Duty Proceedings: Assessment Brazil, Indonesia, Mexico, Moldova, Trinidad and • of Antidumping Duties, 68 FR 23954 (May 6, 2003). Tobago, and Ukraine, 67 FR 65945 (October 29, PTO–2042 9 See 19 CFR 356.8(a). 2002). Type of Request: Regular.

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Number of Respondents: 3,825 fax to 202–395–5197, marked to the account card by providing proper responses per year. attention of Nicholas A. Fraser. identification. Users who wish to Average Hours per Response: The Marcie Lovett, register for the voluntary training USPTO estimates that it will take the courses may do so by completing the public approximately 30 minutes (0.50 Records and Information Governance Division Director, Office of the Chief appropriate form. hours) to read the instructions and Technology Officer, United States Patent and This collection also covers subscriber agreement, gather the Trademark Office. information in applications to establish, necessary information, prepare the [FR Doc. 2018–08020 Filed 4–16–18; 8:45 am] renew, or replace security identification Certificate Action Form, and submit the BILLING CODE 3510–16–P completed request. badges issued under the authority Needs and Uses: provided in 41 CFR part 102–81 to members of the public who wish to This information collection covers the DEPARTMENT OF COMMERCE Certificate Action Form (PTO–2042), access the Public Search Facility. Users which is used by the public to request Patent and Trademark Office may apply for a security badge in person a new digital certificate, revoke a at the USPTO Security Office by current certificate, or recover a lost or Submission for OMB Review; providing the completed application corrupted certificate. Customers may Comment Request; ‘‘Public Search (including applicant and contact also change the name listed on the Facility User ID and Badging’’ information) and presenting a valid form of identification with photograph. certificate or associate the certificate The United States Patent and The security badges include a color with one or more Customer Numbers. A Trademark Office (USPTO) will submit Customer Number allows an applicant to the Office of Management and Budget photograph of the user and must be to associate all correspondence and (OMB) for clearance the following worn always while at the USPTO USPTO actions regarding multiple proposal for collection of information facilities. patent applications to a single address under the Paperwork Reduction Act (44 Frequency: On occasion. and name. The Certificate Action Form U.S.C. Chapter 35). must include a notarized signature in Respondent’s Obligation: Required to Agency: United States Patent and Obtain or Retain Benefits. order to verify the identity of the Trademark Office, Commerce. application. The Certificate Action Form Title: Public Search Facility User ID OMB Desk Officer: Nicholas A. Fraser, _ _ has an accompanying subscriber and Badging. email: Nicholas A. Fraser@ agreement to ensure that customers OMB Control Number: 0651–0041. omb.eop.gov. Once submitted, the understand their obligations regarding Forms: request will be publicly available in the use of the digital certificates and • PTO–2030 electronic format through reginfor.gov. cryptographic software. When • PTO–2224 Follow the instructions to view generating a new certificate, customers Number of Respondents: 6,250 Department of Commerce collections also register to receive a set of seven responses per year. currently under review by OMB. codes that will enable customers to Average Hours per Response: The recover a lost certificate online without Further information can be obtained USPTO estimates that it will take the by: having to contact USPTO support staff. public between approximately 5 • Frequency: On occasion. minutes (0.08 hours) and 10 minutes Email: InformationCollection@ Respondent’s Obligation: Required to (0.17 hours) to complete the information uspto.gov. Include ‘‘0651–0041 copy Obtain or Retain Benefits. in this collection, depending on the request’’ in the subject line of the OMB Desk Officer: Nicholas A. Fraser, application. This includes the time to message. _ _ email: Nicholas A. Fraser@ gather the necessary information, • Mail: Marcie Lovett, Records and omb.eop.gov. Once submitted, this prepare the appropriate form, and Information Governance Division request will be publicly available in submit the completed request to the Director, Office of the Chief Information electronic format through USPTO. Technology Officer, United States www.reginfo.gov. Follow the Burden Hours: 500 hours. Patent and Trademark Office, P.O. Box instructions to view Department of Cost Burden: $1,501.96. 1450, Alexandria, VA 22313–1450. Commerce collections currently under Needs and Uses: review by OMB. This collection covers information Written comments and Further information can be obtained that individuals submit in applications recommendations for the proposed by: to establish a USPTO online access information collection should be sent on • Email: InformationCollection@ account. This application allows users or before May 17, 2018 to Nicholas A. uspto.gov. Include ‘‘0651–0045 copy to obtain, renew, or replace online Fraser. OMB Desk Officer, via email to request’’ in the subject line of the access account cards which provide [email protected] by message. access to the electronic search system at fax to 202–395–5167, marked to the • Mail: Marcie Lovett, Records and the Public Search Facility. The public attention of Nicholas A. Fraser. Information Governance Division may apply for an online access account Director, Office of the Chief Technology only at the Public Search Facility Marcie Lovett, Officer, United States Patent and reference desk by providing the Records and Information Governance Trademark Office, P.O. Box 1450, completed application (including Division Director, Office of the Chief Alexandria, VA 22313–1450. contact information) and proper Technology Officer, United States Patent and Written comments and identification. The access account cards Trademark Office. recommendations for the proposed include a bar-coded user number and an [FR Doc. 2018–08019 Filed 4–16–18; 8:45 am] information collection should be sent on expiration date. Users may renew their BILLING CODE 3510–16–P or before May 17, 2018 to Nicholas A. account card in person by validating Fraser, OMB Desk Officer, via email to and updating the required information [email protected] or by and may obtain a replacement for a lost

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DEPARTMENT OF COMMERCE Individuals and businesses may also denied a filing date. The request must submit various communications to the include evidence showing that the Patent and Trademark Office USPTO, including letters of protest, applicant is entitled to the earlier filing requests to make special, responses to date. Trademark Petitions petition inquiry letters, petitions to If an applicant has proof that an make special, requests to restore a filing ACTION: Proposed collection; comment application was inadvertently date, and requests for reinstatement. request. abandoned due to a USPTO error, an The USPTO uses the information applicant may file a request to reinstate SUMMARY: The United States Patent and described in this collection to process the application instead of a formal Trademark Office (USPTO), as required letters of protests, requests to make petition to revive. To support such a by the Paperwork Reduction Act of special, responses to petition inquiry request, the applicant must include 1995, invites comments on a proposed letters, petitions to make special, clear evidence of the USPTO error. extension of an existing information requests to restore filing date, and II. Method of Collection collection: 0651–0061 (Trademark requests for reinstatement. The Petitions). information is used by the public for a Electronically, if applicants submit variety of private business purposes the information using the forms DATES: Written comments must be related to establishing and enforcing submitted on or before June 18, 2018. available through the Trademark trademark rights. Information relating to Electronic Application System (TEAS). ADDRESSES: You may submit comments the registration of a trademark is made By mail or hand delivery, if applicants by any of the following methods: available to the public by the USPTO. choose to submit the information in • Email: InformationCollection@ However, the release of information in paper form. uspto.gov. Include ‘‘0651–0061 a letter of protest is controlled and may comment’’ in the subject line of the be available only upon request. III. Data message. A letter of protest is an informal OMB Number: 0651–0061. • Federal Rulemaking Portal: http:// procedure whereby third parties who IC Instruments and Forms: N/A. www.regulations.gov. object to the registration of a mark in a • Mail: Marcie Lovett, Records and Type of Review: Revision of a pending application may bring to the currently approved collection. Information Governance Division attention of the USPTO evidence Director, Office of the Chief Technology Affected Public: Individuals or bearing on the registrability of the mark. households; business or other for-profit Officer, United States Patent and A letter of protest must identify the Trademark Office, P.O. Box 1450, organizations; not-for-profit application being protested and the organizations. Alexandria, VA 22313–1450. proposed grounds for refusing Estimated Number of Respondents: FOR FURTHER INFORMATION CONTACT: registration and include relevant 4,768 responses per year. Requests for additional information evidence to support the protest. should be directed to Catherine Cain, A request to make special may be Estimated Time per Response: The Attorney Advisor, Office of the submitted where an applicant requests USPTO estimates that it will take Commissioner for Trademarks, United that initial examination of an approximately between 35 minutes States Patent and Trademark Office, application be advanced out of its (0.58 hours) to 75 minutes (1.25 hours) P.O. Box 1450, Alexandria, VA 22313– regular order because the mark in the to complete items in this collection. 1450; by telephone at 571–272–8946; or application was the subject of an This includes the time to gather the by email to [email protected] inadvertently cancelled or expired necessary information, create the with ‘‘0651–0061 comment’’ in the previous registration. documents, and submit the completed subject line. Additional information A response to a petition inquiry letter request to the USPTO. about this collection is also available at is submitted by a petitioner who is Estimated Total Annual Respondent http://www.reginfo.gov under responding to a notice of deficiency that Burden Hours: 4,333.63 hours per year. ‘‘Information Collection Review.’’ the USPTO issued after receiving an Estimated Total Annual Respondent SUPPLEMENTARY INFORMATION: incomplete petition to the Director. A (Hourly) Cost Burden: $1,898,129.94. petition may be considered incomplete The USPTO expects that an attorney I. Abstract if, for example, it does not include the will complete the instruments The United States Patent and fee required by 37 CFR 2.6 or if it associated with this information Trademark Office (USPTO) administers includes an unverified assertion that is collection. The professional hourly rate the Trademark Act, 15 U.S.C. 1051 et not supported by evidence. for attorneys is $438, which is the seq., which provides for the registration The USPTO generally examines median professional rate for intellectual of trademarks, service marks, collective applications in the order in which they property attorneys in private firms as trademarks and collective service marks, are received. A petition to make special shown in the 2017 Report of the collective membership marks, and is a request by the applicant to advance Economic Survey published by the certification marks. Individuals and the initial examination of an application American Intellectual Property Law businesses that use or intend to use out of its regular order. Association (AIPLA). Using this hourly such marks in commerce may file an A request to restore a filing date is rate, the USPTO estimates that the total application to register their marks with submitted by an applicant who respondent cost burden for this the USPTO. previously filed an application that was collection is $1,898,129.94 per year.

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Time for IC No. Item response Responses Burden hours Rate Total cost (hours)

(a) (b) (c) (d) (e) (a) × (d) (c) × (d)

1 ...... Letter of Protest (TEAS Global) ...... 1 (60 minutes) ...... 3,475 3,475.00 $438.00 $1,522,050.00 1 ...... Letter of Protest (Paper) ...... 1.25 (75 minutes) ...... 10 12.50 438.00 5,475.00 2 ...... Request to Make Special (TEAS 0.58 (35 minutes) ...... 150 87.00 438.00 38,106.00 Global). 2 ...... Request to Make Special (Paper) ...... 0.75 (45 minutes) ...... 1 0.75 438.00 328.50 3 ...... Response to Petition to Director In- 0.75 (45 minutes) ...... 274 205.50 438.00 90,009.00 quiry Letter (TEAS Global). 3 ...... Response to Petition to Director In- 1 (60 minutes) ...... 1 1.00 438.00 438.00 quiry Letter (Paper). 4 ...... Petition to Make Special (TEAS Glob- 0.58 (35 minutes) ...... 531 307.98 438.00 134,895.25 al). 4 ...... Petition to Make Special (Paper) ...... 0.75 (45 minutes) ...... 2 1.5 438.00 657.00 5 ...... Request to Restore Filing Date 0.58 (35 minutes) ...... 5 2.90 438.00 1,270.20 (TEAS Global). 5 ...... Request to Restore Filing Date 0.75 (45 minutes) ...... 1 0.75 438.00 328.50 (Paper). 6 ...... Request for Reinstatement (TEAS 0.75 (45 minutes) ...... 317 237.75 438.00 104,134.50 Global). 6 ...... Request for Reinstatement (Paper) ... 1 (60 minutes) ...... 1 1.00 438.00 438.00

Total ...... 4,768 4,333.63 ...... 1,898,129.94

Estimated Total Annual (Non-hour) This collection does have postage cost to Make Special, which has a fee Respondent Cost Burden: $53,307.84 and filing fees. amount of $100 per respondent. The per year. This collection has no capital Filing Fees total estimated filing-fee cost for this start-up, maintenance, or operating fees. collection is $53,300.00 There are fees associated with this collection, specifically for the Petition

IC No. Item Responses Filing fee Total cost

4 ...... Petition to Make Special (TEAS Global) ...... 531 $100.00 $53,100.00 4 ...... Petition to Make Special (Paper) ...... 2 100.00 200.00

Totals ...... 533 ...... 53,300.00

Postage Cost included in the request for OMB collection techniques or other forms of approval of this information collection. information technology. Applicants incur postage costs when They also will become a matter of submitting non-electronic information Marcie Lovett, public record. to the USPTO by mail through the Records and Information Governance United States Postal Service (USPS). Comments are invited on: Division Director, OCTO, United States Patent The USPTO estimates that the vast (a) Whether the proposed collection of and Trademark Office. majority—approximately 98%—of the information is necessary for the proper [FR Doc. 2018–08021 Filed 4–16–18; 8:45 am] paper forms are submitted to the USPTO performance of the functions of the BILLING CODE 3510–16–P via first-class mail, while the rest are agency, including whether the submitted by hand delivery. The information shall have practical utility; USPTO estimates that 16 forms will be DEPARTMENT OF COMMERCE mailed. The average first-class USPS (b) The accuracy of the agency’s postage cost for a mailed submission is estimate of the burden (including hours Patent and Trademark Office $0.50. Therefore, the USPTO estimates and cost) of the proposed collection of that the postage costs for the mailed information; Third-Party Submissions and Protests submissions in this collection will total (c) Ways to enhance the quality, $8. utility, and clarity of the information to ACTION: Proposed collection; comment Therefore, the USPTO estimates that be collected; and request. the total annual (non-hour) cost burden (d) Ways to minimize the burden of for this collection, in the form of filing SUMMARY: the collection of information on The United States Patent and fees ($53,300) and postage costs ($8), is Trademark Office (USPTO), as required respondents, e.g., the use of automated $53,308 per year. by the Paperwork Reduction Act of 1995, invites comments on a proposed IV. Request for Comments extension of an existing information Comments submitted in response to collection: 0651–0062 (Third-Party this notice will be summarized or Submissions and Protests).

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DATES: Written comments must be I. Abstract 1.291 are supported by a separated submitted on or before June 18, 2018. The United States Patent and statutory provision from third-party ADDRESSES: You may submit comments Trademark Office (USPTO) is required submissions under 37 CFR 1.290 (35 by any of the following methods: by 35 U.S.C. 131 et seq. to examine an U.S.C. 122(c) v. 35 U.S.C. 122(e)). As a result, there are several differences • Email: InformationCollection@ application for patent and, when between protests and third-party uspto.gov. Include ‘‘0651–0062 appropriate, issue a patent. The submissions. comment’’ in the subject line of the provisions of 35 U.S.C. 122(c), 122(e), message. 131, and 151, as well as 37 CFR 1.290 For example, 37 CFR 1.291 permits • and 1.291, limit the ability of a third the submission of information in a Federal Rulemaking Portal: http:// party to have information entered and www.regulations.gov. protest that is not permitted in a third- considered in, or to protest, a patent party submission under 37 CFR 1.290. • Mail: Marcie Lovett, Records and application pending before the Office. Specifically, 37 CFR 1.291 provides for Information Governance Division 37 CFR 1.290 provides a mechanism the submission of information, Director, Office of the Chief Technology for third parties to submit to the including any facts or information Officer, United States Patent and USPTO, for consideration and inclusion adverse to patentability. Further, 37 CFR Trademark Office, P.O. Box 1450, in the record of a patent application, 1.291 requires a protest to include a Alexandria, VA 22313–1450. any patents, published patent concise explanation of the relevance of FOR FURTHER INFORMATION CONTACT: applications, or other printed publications of potential relevance to each item of information submitted. Requests for additional information Unlike the concise description of should be directed to Raul Tamayo, the examination of the application. A third-party submission under 37 relevance required for a third-party Senior Legal Advisor, Office of Patent submission under 37 CFR 1.290, which Legal Administration, United States CFR 1.290 may be made in any non- provisional utility, design, and plant is limited to a description of a Patent and Trademark Office, P.O. Box application, as well as in any continuing document’s relevance, the concise 1450, Alexandria, VA 22313–1450; by application. A third-party submission explanation for a protest under 37 CFR telephone at 571–272–7728; or by email under 37 CFR 1.290 must include a 1.291 allows for arguments against to [email protected] with ‘‘0651– concise description of the asserted patentability. Additionally, the 0062 comment’’ in the subject line. relevance of each document submitted, specified time period for submitting a Additional information about this and must be submitted within a certain protest differs from the time period for collection is also available at http:// statutorily specified time period. submitting third-party submissions, and www.reginfo.gov under ‘‘Information 37 CFR 1.291 permits a member of the is impacted by whether the protest is Collection Review.’’ public to file a protest against a pending accompanied by the written consent of SUPPLEMENTARY INFORMATION: application. Protests pursuant to 37 CFR the applicant.

Comparison Third party submission Protest

Statute/Rule ...... 35 U.S.C. 122(e), 37 CFR 1.290 ...... 35 U.S.C. 122(c), 37 CFR 1.291. Content ...... Printed publications ...... Printing publications and any facts or information ad- verse to patentability. Remarks ...... Concise description of relevance (limited to a concise Concise explanation of the relevance (allows for argu- description of each document’s relevance). ments against patentability). Timing ...... Prior to Allowance and prior to later of: 6 months after Prior to Allowance and prior to Pre-Grant Publication Pre-Grant Publication or first rejection of any claim. OR Prior to Allowance and after and after Pre-Grant Publication with application consent.

This information collection is Affected Public: Individuals or The USPTO expects that intellectual necessary so that the public may households; businesses or other for- property attorneys in private firms will contribute to the quality of issued profits; and not-for-profit institutions. complete the instruments associated patents. The USPTO will use this Estimated Number of Respondents: with this information collection. The information, as appropriate, to assist in 1,450 responses per year. professional hourly rate is $438. The evaluating the patent application as it Estimated Time per Response: The rate is established by estimates in the moves through the patent examination USPTO estimates that it will take the 2017 Report on the Economic Survey, pubic approximately 10 hours to gather process. published by the Committee on the necessary information, prepare the Economics of Legal Practice of the II. Method of Collection appropriate form or document, and American Intellectual Property Law OMB Number: 0651–0062. submit the information to the USPTO. Estimated Total Annual Hour Burden: Association. Using this hourly rate, the IC Instruments: PTO/SB/429. 14,500 hours. USPTO estimates that the total Type of Review: Extension of a Estimated Annual Respondent respondent cost burden for this currently approved collection. (Hourly) Cost Burden: $6,351,000.00. collection is $6,351,000 per year.

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TABLE 1—BURDEN HOUR AND COST

Response Annual IC No. Item time Responses burden Rate Total cost (hours) hours

(a) (b) (c) (d) (e) (a) × (b) (c) × (d)

1 ...... Third-Party Submissions in Non- 10 1,400 14,000 $438.00 $6,132,000.00 issued Applications (electronic). 2 ...... Third-Party Submissions in Non- 10 40 400 438.00 175,200.00 issued Applications (paper). 3 ...... Protests by the Public Against Pend- 10 10 100 438.00 43,800.00 ing Applications Under 37 CFR 1.291 (paper).

Total ...... 1,450 14,500 ...... 6,351,000.00

Estimated Total Annual (Non-hour) a third-party submission listing three or The USPTO estimates that only 1 out of Respondent Cost Burden: $74,160 per fewer total documents is the first third- every 10 protests filed per year will year. There are no capital start-up, party submission submitted in an require this fee. recordkeeping or maintenance costs application by the third party, or a party When electronically submitting the associated with this information in privity with the third party. The information in this collection to the collection. There are, however, annual effect of this is that the first three USPTO, the applicant is encouraged to (non-hour) costs associated with this documents submitted by a third party retain a copy of the file submitted to the information collection in the forms of are exempt from the fee requirement. USPTO as evidence of the application. filing fees and postage costs. In However, the submission of four or Inclusion of an USPS acknowledgement particular, 37 CFR 1.290 requires more documents by a third party receipt with mailed items provides payment of the fee set forth in 37 CFR triggers the collection of the fee. evidence of the date the file was 1.17(o) ($180 undiscounted; $90 for a There is no fee for filing protests received by the USPTO. The USPTO small or micro entity) for every ten under 37 CFR 1.291 unless the filed does not, however, require this documents, or fraction thereof, listed in protest is the second or subsequent recordkeeping, and thus does not each third-party submission. protest by the same real party in consider this action to be a The USPTO provides an exemption interest, in which case the 37 CFR recordkeeping cost imposed on the from the 1.17(o) fee requirement where 1.17(i) fee of $130 must be included. applicant.

TABLE 2—FILING FEES

Estimated Total Non-hour IC No. Item annual Filing fee ($) cost burden responses ($)

(a) (b) (a) × (b) = (c)

1–2 ...... Third-Party Submissions in Non-issued Applications ...... 410 $180.00 $73,800.00 1–2 ...... Third-Party Submissions in Non-issued Applications (small and micro entities) 170 90.00 15,300.00 3 ...... Protests by the Public Against Pending Applications Under 37 CFR 1.291 ...... 1 130.00 130.00

Total ...... 581 ...... 73,930.00

This collection also has non-hourly require postage. Therefore, the performance of the functions of the annual cost burden in the form of estimated postage cost for this collection agency, including whether the postage costs. Customers may incur will be $268. information shall have practical utility; postage costs when submitting the The total non-hour respondent cost (b) The accuracy of the agency’s burden for this collection in the form of instruments contained within this estimate of the burden (including hours filing fees ($73,930) and postage costs collection to the USPTO by mail and cost) of the proposed collection of ($268) is approximately $74,198. through the United States Postal information; Service. The USPTO estimates that the IV. Request for Comments (c) Ways to enhance the quality, average first class postage cost for a one- Comments submitted in response to utility, and clarity of the information to pound submission mailed in a flat-rate this notice will be summarized or be collected; and envelope to be $6.70. The USPTO included in the request for OMB estimates that the vast majority— (d) Ways to minimize the burden of approval of this information collection. the collection of information on roughly 98 percent—of all paper They will also become a matter of respondents, e.g., the use of automated submissions will be delivered by mail, public record. with the remainder being delivered by Comments are invited on: hand delivery, for an estimated that (a) Whether the proposed collection of approximately 40 submissions will information is necessary for the proper

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collection techniques or other forms or NW, Washington, DC 20552, on official the Bureau has not published its information technology. business days between the hours of 10 definition of consumer inquiries; a.m. and 5 p.m. Eastern Time. You can however, as an operational matter for Marcie Lovett, make an appointment to inspect the the purposes of establishing reasonable Records and Information Governance documents by telephoning 202–435– procedures for providing timely Division Director, OCTO, United States Patent 7275. responses to consumer inquiries and for and Trademark Office. All submissions in response to this the purposes of this request for [FR Doc. 2018–08022 Filed 4–16–18; 8:45 am] request for information, including information, the Bureau defines BILLING CODE 3510–16–P attachments and other supporting consumer inquiries as consumer materials, will become part of the public requests for information—typically record and subject to public disclosure. proffered by telephone—to its Office of BUREAU OF CONSUMER FINANCIAL Proprietary information or sensitive Consumer Response about consumer PROTECTION personal information, such as account financial products or services, the status [Docket No. CFPB–2018–0014] numbers or Social Security numbers, or of a complaint, an action taken by the names of other individuals, should not Bureau, and often combinations Request for Information Regarding the be included. Submissions will not be thereof.5 Bureau’s Consumer Complaint and edited to remove any identifying or Since it began accepting consumer Consumer Inquiry Handling Processes contact information. complaints and consumer inquiries in FOR FURTHER INFORMATION CONTACT: July 2011, the Bureau has established AGENCY: Bureau of Consumer Financial Darian Dorsey, Deputy Assistant reasonable procedures to provide Protection. Director, Office of Consumer Response, consumers with timely responses to ACTION: Notice and request for at 202–435–7268. If you require this their complaints and inquiries, in information. document in an alternative electronic writing where appropriate.6 To date, the format, please contact CFPB_ Bureau has received more than 1.5 SUMMARY: The Bureau of Consumer Financial Protection (Bureau) is seeking [email protected]. million consumer complaints. The comments and information from SUPPLEMENTARY INFORMATION: An consumer complaint process seeks to interested parties to assist the Bureau in important aspect of the Bureau’s provide consumers with timely assessing its handling of consumer mission is hearing directly from the responses to their complaints, while the complaints and consumer inquiries and, American public about their consumer inquiry process aims to consistent with law, considering experiences in the consumer financial provide timely answers to consumers whether changes to its processes would marketplace. Pursuant to 12 U.S.C. who submit inquiries. Both processes be appropriate. 5511(c)(2), ‘‘collecting, investigating, support the Bureau’s statutory objective and responding to consumer to provide consumers with timely and DATES: Comments must be received by complaints’’ is one of the six statutory understandable information about July 16, 2018. ‘‘primary functions’’ of the Bureau. In consumer financial products and ADDRESSES: You may submit responsive addition, ensuring that ‘‘consumers are services to make responsible decisions. information and other comments, provided with timely and To that end, the Bureau has established identified by Docket No. CFPB–2018– understandable information to make reasonable procedures for responding to 0014, by any of the following methods: • responsible decisions about financial both consumer complaints and Electronic: Go to http:// transactions’’ is one of its six consumer inquiries. www.regulations.gov. Follow the enumerated objectives.1 Though the Bureau is required to instructions for submitting comments. • In furtherance of these statutory establish reasonable procedures to Email: FederalRegisterComments@ mandates, the Dodd-Frank Wall Street provide timely responses to consumer cfpb.gov. Include Docket No. CFPB– Reform and Consumer Protection Act complaints and consumer inquiries, 2018–0014 in the subject line of the (Dodd-Frank Act) requires the Bureau to certain aspects of the complaint and message. • establish a unit to ‘‘facilitate the inquiry handling processes were Mail: Comment Intake, Consumer centralized collection of, monitoring of, developed in furtherance of those Financial Protection Bureau, 1700 G and response to consumer complaints statutory requirements but are not Street NW, Washington, DC 20552. regarding consumer financial products directly mandated by statute. Mindful of • Hand Delivery/Courier: Comment or services’’ 2 and directs the Bureau to the Bureau’s statutory objective to Intake, Consumer Financial Protection establish reasonable procedures to provide consumers with timely and Bureau, 1700 G Street NW, Washington, provide timely responses to consumer understandable information about DC 20552. complaints and consumer inquiries.3 consumer financial products and Instructions: The Bureau encourages The Bureau defines consumer the early submission of comments. All services so they can make responsible complaints as ‘‘submissions that express decisions, as well as its statutory submissions must include the document dissatisfaction with, or communicate title and docket number. Please note the obligations to (1) establish reasonable suspicion of wrongful conduct by, an procedures to provide consumers with number of the topic on which you are identifiable entity related to a commenting at the top of each response timely responses and (2) centralize the consumer’s personal experience with a collection of consumer complaints (you do not need to address all topics). financial product or service.’’ 4 To date, Because paper mail in the Washington, about consumer financial products or DC area and at the Bureau is subject to 1 12 U.S.C. 5511(b)(1). 5 12 U.S.C. 5511(b)(1) authorizes the Bureau to delay, commenters are encouraged to 2 The Bureau’s Office of Consumer Response ensure that, with respect to consumer financial submit comments electronically. In (‘‘Consumer Response’’) serves these and other products and services, ‘‘consumers are provided general, all comments received will be functions. 12 U.S.C. 5493(b)(3)(A). with timely and understandable information to posted without change to http:// 3 12 U.S.C. 5534(a). make responsible decisions about financial 4 Consumer Financial Protection Bureau, transactions’’; some of this work occurs in the www.regulations.gov. In addition, Consumer Response Annual Report (Mar. 2012), consumer complaint and inquiry processes comments will be available for public available at http://files.consumerfinance.gov/f/ performed within the Office of Consumer Response. inspection and copying at 1700 G Street 201204_cfpb_ConsumerResponseAnnualReport.pdf. 6 12 U.S.C. 5534(a).

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services, the Bureau has used feedback Consumer Inquiry Process. The Bureau’s public reporting practices of from a variety of stakeholders to Bureau’s single, toll-free telephone consumer complaint information, establish and refine its processes over number 11 gives consumers the consistent with law, to consider time to improve stakeholders’ opportunity to ask questions about whether any changes to the practices experience, handle large volumes of financial products or services, submit a would be appropriate.12 The Bureau complaints and inquiries,7 and increase complaint, and check the status of a will consider for the purposes of this overall efficiency. complaint. Consumers can also inquire RFI, and to the extent relevant, all Consumer Complaint Process. To about the Bureau and a subset of its comments previously received in ‘‘facilitate the centralized collection of, recent actions. When consumers call connection with that request. monitoring of, and response to with an inquiry about consumer Respondents, therefore, should not feel consumer complaints regarding financial products or services, a Bureau any obligation to include in their consumer financial products or representative collects basic information responses to this RFI suggestions and services,’’ the Bureau accepts about the consumer, listens to the comments already submitted in complaints through its website; by consumer describe their situation and response to the call for evidence on referral from the White House, question, and provides clear, unbiased public reporting practices of consumer congressional offices, Federal agencies, educational information about financial complaint information. and State agencies; and by telephone, products and services. Representatives Suggested Topics for Commenters mail, email, and fax. When consumers 8 do not provide legal advice to choose to submit complaints, the consumers, nor do they encourage To allow the Bureau to evaluate Bureau’s complaint form prompts them consumers to take any particular action. suggestions more effectively, the Bureau to select the consumer financial product Instead, when appropriate, requests that, where possible, comments or service with which they have a representatives direct consumers to include: problem as well as the type of problem Bureau educational materials and tools, • Specific discussion of the positive they are having with that product or and other relevant government and negative aspects of the Bureau’s service. This provides information that resources. The Bureau’s U.S.-based complaint and inquiry processes; can be used to group complaints to contact center provides services to • Specific suggestions regarding any understand the financial products and consumers in more than 180 languages potential updates or modifications to services about which consumers and to consumers who are deaf, have the Bureau’s complaint and inquiry complain to the Bureau. The complaint hearing loss, or have speech disabilities. processes, consistent with the law and form also requires consumers to affirm In 2017, the Bureau received more than given one of the Bureau’s statutory that the information provided in their 200,000 consumer inquiries. obligations is to establish reasonable complaint is true to the best of their Overview of This Request for procedures to provide consumers with knowledge and belief. The Bureau Information timely responses to complaints and routes complaints about consumer inquiries, including, in as much detail The Bureau is using this request for financial products and services directly as possible, the nature of the information (RFI) to seek public input to financial companies and works with modification, and supporting data or regarding potential changes that can be them to get consumers a timely response other information on impacts and costs; from the company, generally within 15 implemented to the Bureau’s consumer • Specific best practices for days. Where appropriate, complaints are complaint and inquiry handling complaint and inquiry processes given routed to other Federal agencies.9 The processes, consistent with law, to the Bureau’s statutory objectives and company reviews the information, consider whether any changes to functions, including ensuring communicates with the consumer as existing practices would be appropriate consumers are provided with timely and needed, and determines what action to given the Bureau’s statutory objective to understandable information to make take in response. The company then provide consumers with timely and responsible decisions about financial responds to the consumer and the understandable information about transactions 13 and centralizing the Bureau in writing via the secure consumer financial products and collection of consumer complaints company portal, and the Bureau invites services to make responsible decisions about consumer financial products or the consumer to review the company’s as well as its statutory obligations to (1) services. response and provide feedback about establish reasonable procedures to the response received from the provide timely responses to consumers The following represents a company. Consumers can log onto the and (2) centralize the collection of preliminary attempt by the Bureau to secure consumer portal available on the consumer complaints regarding identify elements of the Bureau’s Bureau’s website or call the Bureau to consumer financial products or services. complaint and inquiry processes on receive status updates, provide The Bureau encourages comments from which commenters may want to additional information, and review all interested members of the public, comment. This non-exhaustive list is responses provided by the company. In including financial industry meant to assist in the formulation of 2017, the Bureau handled more than participants, government agencies, comments and is not intended to restrict 320,000 consumer complaints.10 academic and research organizations, the issues that may be addressed. In consumer advocacy and financial addressing these issues and questions, 7 In 2017, the Bureau received more than 500,000 education groups, trade associations, the Bureau requests that commenters consumer complaints and consumer inquiries. and consumers. identify with specificity the complaint 8 The term ‘consumer’ means an individual or an The Bureau previously issued an RFI or inquiry processes feature at issue, agent, trustee, or representative acting on behalf of seeking public input regarding potential providing legal citations where an individual.’’ 12 U.S.C. 5481(4) appropriate and available. 9 The Bureau refers or sends complaints to changes that can be implemented to the another regulator when, for example, a particular complaint does not involve a product or service available at https://www.consumerfinance.gov/ 12 Request for Information Regarding Bureau currently handled by the Bureau. documents/6406/cfpb_consumer-response-annual- Public Reporting Practices of Consumer Complaint 10 Consumer Financial Protection Bureau, report_2017.pdf. Information, 83 FR 9499 (March 6, 2018). Consumer Response Annual Report (Apr. 2018), 11 12 U.S.C. 5493(b)(3)(A). 13 12 U.S.C. 5511(b)(1).

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The Bureau is seeking feedback on all Authority: 12 U.S.C. 5511(c). comments and other submissions from aspects of its consumer complaint and Dated: April 10, 2018. members of the public is to make these inquiry handling processes, including: Mick Mulvaney, submissions available for public 1. Specific statutorily-permissible viewing on the internet at http:// Acting Director, Bureau of Consumer suggestions regarding how the Bureau Financial Protection. www.regulations.gov as they are currently allows consumers to submit received without change, including any [FR Doc. 2018–07943 Filed 4–16–18; 8:45 am] complaints and inquiries, including: personal identifiers or contact a. Should the Bureau require BILLING CODE 4810–AM–P information. consumers to classify their submission FOR FURTHER INFORMATION CONTACT: affirmatively as a consumer complaint DEPARTMENT OF DEFENSE Lieutenant Commander Rachel Trest, or inquiry prior to submission? JAGC, USN, United States Navy-Marine b. How should the Bureau explain the Office of the Secretary Corps Court of Criminal Appeals, (202) difference between a consumer 685–4621, [email protected]. complaint and a consumer inquiry to [Docket ID: DoD–2018–OS–0019] SUPPLEMENTARY INFORMATION: As the consumers at the point of submission? c. Should the Bureau develop a Joint Rules of Appellate Procedure for proposed revisions to the JRAP are process for companies to reclassify Courts of Criminal Appeals; Proposed substantial, the full text of the proposed new JRAP is available electronically at consumers’ submissions? If so, what Changes www.regulations.gov, searchable by criteria should the Bureau establish to AGENCY: Joint Rules of Appellate Docket ID: DoD–2018–OS–0019. The help companies differentiate consumer Procedure for Courts of Criminal current text of the JRAP is available for complaints from consumer inquiries? Appeals (JRAP) Committee, Department 2. Specific statutorily-permissible comparison electronically at of Defense. suggestions regarding the Bureau’s www.regulations.gov, searchable by Docket ID: DoD–2018–OS–0019. consumer complaint processes, ACTION: Notice of availability of The JRAP Committee invites members including: proposed changes to the Joint Rules of of the public to comment on the a. The Bureau currently receives Appellate Procedure for Courts of proposed new rules; such comments complaints via six channels: Website, Criminal Appeals. should address specific recommended referral from Federal and State entities/ SUMMARY: This notice announces changes and provide supporting agencies, telephone, mail, fax, and proposed changes to the Joint Rules of rationale. email. Should the Bureau add or Appellate Procedure for Courts of This notice is intended only to discontinue any channels for accepting Criminal Appeals (JRAP), which improve the internal management of the complaints? prescribe uniform procedures for the Federal Government. It is not intended b. Consistent with the Dodd-Frank service Courts of Criminal Appeals. to create any right or benefit, Act’s definition of ‘‘consumer,’’ the Although these rules of practice and substantive or procedural, enforceable at Bureau currently allows consumers to procedure fall within the law by any party against the United authorize someone else (e.g., lawyer, Administrative Procedure Act’s States, its agencies, its officers, or any advocate, power of attorney) to submit exemptions for notice and comment, the person. complaints on their behalf. Should the Department, as a matter of policy, has Bureau expand, limit, or maintain the Dated: April 10, 2018. decided to make these changes available Shelly E. Finke, ability of authorized third parties to for public review and comment before Alternate OSD Federal Register Liaison submit complaints? they are implemented. The proposed 3. Specific statutorily-permissible Officer, Department of Defense. changes implement the Military Justice suggestions regarding the Bureau’s [FR Doc. 2018–07965 Filed 4–16–18; 8:45 am] Act of 2016 of the National Defense consumer inquiry processes, including: BILLING CODE 5001–06–P Authorization Act of 2017 and the 2018 a. The Bureau currently accepts Amendments to the Manual for Courts- consumer inquiries via telephone and Martial, United States. The approval mail. Should the Bureau add or DEPARTMENT OF EDUCATION authorities for these changes are the discontinue any channels for accepting Judge Advocates General of the Army, [Docket No.: ED–2018–ICCD–0007] inquiries? b. Should the Bureau develop web Navy, Air Force, and Coast Guard. DATES: Comments on the proposed Agency Information Collection chat systems to support consumers’ Activities; Submission to the Office of submission of inquiries? changes must be received no later than May 17, 2018. Management and Budget for Review c. Should the Bureau develop a and Approval; Comment Request; ADDRESSES: process for companies to provide timely You may submit comments, Teacher Education Assistance for responses to consumer inquiries sent to identified by docket number and title by College and Higher Education Grant them by the Bureau? If so, how should any of the following methods: Program (TEACH Grant Program) • Federal eRulemaking Portal: http:// the Bureau balance its objective of Agreement To Serve providing timely and understandable www.regulations.gov. Follow the information to consumers 14 with its instructions for submitting comments. AGENCY: Federal Student Aid (FSA), objective of reducing unwarranted • Mail: Department of Defense, Office Department of Education (ED). regulatory burden on companies? 15 of the Deputy Chief Management ACTION: Notice. d. Should the Bureau publish data Officer, Directorate for Oversight and about consumer inquiries? If so, what Compliance, 4800 Mark Center Drive, SUMMARY: In accordance with the types of data or analyses about Mailbox #24, Alexandria, VA 22350– Paperwork Reduction Act of 1995, ED is consumer inquiries should be shared 1700. proposing a revision of an existing with the public? Instructions: All submissions received information collection. must include the agency name and DATES: Interested persons are invited to 14 12 U.S.C. 5511(b)(1). docket number for this Federal Register submit comments on or before May 17, 15 12 U.S.C. 5511(b)(3). document. The general policy for 2018.

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ADDRESSES: To access and review all the Type of Review: A revision of an disposition; stabilization and documents related to the information existing information collection. disposition of non-stockpile nuclear collection listed in this notice, please Respondents/Affected Public: materials; excess facilities; future land use http://www.regulations.gov by Individuals or Households. use and long-term stewardship; risk searching the Docket ID number ED– Total Estimated Number of Annual assessment and management; and clean- 2018–ICCD–0007. Comments submitted Responses: 50,793. up science and technology activities. in response to this notice should be Total Estimated Number of Annual Additionally, the renewal of the submitted electronically through the Burden Hours: 25,397. Board has been determined to be Federal eRulemaking Portal at http:// Abstract: As a condition for receiving essential to conduct DOE’s business and www.regulations.gov by selecting the a TEACH Grant, a student must sign an to be in the public interest in Docket ID number or via postal mail, Agreement to Serve. A new Agreement connection with the performance of commercial delivery, or hand delivery. to Serve must be signed for each award duties imposed on the DOE by law and Please note that comments submitted by year during which a student wishes to agreement. The Board will operate in fax or email and those submitted after receive a TEACH Grant. By signing the accordance with the provisions of the the comment period will not be Agreement to Serve, a TEACH Grant Federal Advisory Committee Act, and accepted. Written requests for recipient agrees to meet the teaching rules and regulations issued in information or comments submitted by service obligation and other terms and implementation of that Act. conditions of the TEACH Grant Program postal mail or delivery should be FOR FURTHER INFORMATION CONTACT: Mr. that are described in the Agreement to addressed to the Director of the David Borak, Designated Federal Service. In accordance with these terms Information Collection Clearance Officer, at (202) 586–9928 or and conditions, if a TEACH Grant Division, U.S. Department of Education, [email protected]. 400 Maryland Avenue SW, LBJ, Room recipient does not fulfill the required Issued in Washington, DC, on April 11, 216–34, Washington, DC 20202–4537. teaching service obligation or otherwise fails to meet the requirements of the 2018. FOR FURTHER INFORMATION CONTACT: For TEACH Grant Program, any TEACH Wayne D. Smith, specific questions related to collection Grant funds the individual received will Committee Management Officer. activities, please contact Jon Utz, 202– be converted to a Direct Unsubsidized [FR Doc. 2018–07995 Filed 4–16–18; 8:45 am] 377–4040. Loan that the grant recipient must repay BILLING CODE 6450–01–P SUPPLEMENTARY INFORMATION: The in full, with interest. The Agreement to Department of Education (ED), in Serve also explains the repayment terms accordance with the Paperwork and conditions that will apply if a DEPARTMENT OF ENERGY Reduction Act of 1995 (PRA) (44 U.S.C. TEACH Grant is converted to a Direct 3506(c)(2)(A)), provides the general Unsubsidized Loan. Agency Information Collection public and Federal agencies with an Extension opportunity to comment on proposed, Dated: April 11, 2018. revised, and continuing collections of Kate Mullan, AGENCY: U.S. Department of Energy. information. This helps the Department Acting Director, Information Collection ACTION: Notice and request for assess the impact of its information Clearance Division, Office of the Chief Privacy comments. collection requirements and minimize Officer, Office of Management. SUMMARY: The Department of Energy the public’s reporting burden. It also [FR Doc. 2018–07940 Filed 4–16–18; 8:45 am] (DOE), pursuant to the Paperwork helps the public understand the BILLING CODE 4000–01–P Reduction Act of 1995, intends to Department’s information collection extend for three years, an information requirements and provide the requested collection request with the Office of data in the desired format. ED is DEPARTMENT OF ENERGY Management and Budget (OMB). soliciting comments on the proposed Comments are invited on: (a) Whether information collection request (ICR) that Environmental Management Site- the extended collection of information is described below. The Department of Specific Advisory Board is necessary for the proper performance Education is especially interested in AGENCY: Office of Environmental of the functions of the agency, including public comment addressing the Management, Department of Energy. whether the information shall have following issues: (1) Is this collection ACTION: Notice of Renewal. practical utility; (b) the accuracy of the necessary to the proper functions of the agency’s estimate of the burden of the Department; (2) will this information be SUMMARY: Pursuant to the Federal proposed collection of information, processed and used in a timely manner; Advisory Committee Act, and following including the validity of the (3) is the estimate of burden accurate; consultation with the Committee methodology and assumptions used; (c) (4) how might the Department enhance Management Secretariat, General ways to enhance the quality, utility, and the quality, utility, and clarity of the Services Administration, notice is clarity of the information to be information to be collected; and (5) how hereby given that the Environmental collected; and (d) ways to minimize the might the Department minimize the Management Site-Specific Advisory burden of the collection of information burden of this collection on the Board (EM SSAB or Board) will be on respondents, including through the respondents, including through the use renewed for a two-year period beginning use of automated collection techniques of information technology. Please note on April 11, 2018. or other forms of information that written comments received in The Board provides the Assistant technology. response to this notice will be Secretary for Environmental considered public records. Management (EM) with advice and DATES: Comments regarding this Title of Collection: Teacher Education recommendations concerning issues proposed information collection must Assistance for College and Higher affecting the EM program at various be received on or before June 18, 2018. Education Grant Program (TEACH Grant sites. These site-specific issues include If you anticipate difficulty in submitting Program) Agreement to Serve. clean-up standards and environmental comments within that period, contact OMB Control Number: 1845–0083. restoration; waste management and the person listed in the FOR FURTHER

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INFORMATION CONTACT section as soon as FOR FURTHER INFORMATION CONTACT: DEPARTMENT OF ENERGY possible. David Borak, EM SSAB Designated ADDRESSES: Written comments may be Federal Officer, U.S. Department of [FE Docket No. 18–35–LNG] sent to Alesia Gant, U.S. Department of Energy, 1000 Independence Avenue Energy, 1000 Independence Avenue SW, Washington, DC 20585; Phone: Sabine Pass Liquefaction, LLC; SW, Washington, DC 20585–1615, or by (202) 586–9928. Application for Blanket Authorization email at [email protected]; Ms. SUPPLEMENTARY INFORMATION: To Export Previously Imported Gant may also be contacted at (202) Purpose of the Board: The purpose of Liquefied Natural Gas on a Short-Term 287–1476. the Board is to make recommendations Basis FOR FURTHER INFORMATION CONTACT: to DOE–EM and site management in the AGENCY: Office of Fossil Energy, DOE. Alesia Gant at the address listed in areas of environmental restoration, ACTION: Notice of application. ADDRESSES. Reporting requirements can waste management, and related be found at: https://energy.gov/sites/ activities. SUMMARY: The Office of Fossil Energy prod/files/2016/01/f28/ Tentative Agenda Topics: (FE) of the Department of Energy (DOE) Policy%20Flash%202016-11%20- Thursday, May 3, 2018 gives notice of receipt of an application %20Model%20H-Clause%201-14- Æ EM Program Update (Application), filed on March 23, 2018, 16.pdf. Æ EM SSAB Chairs’ Round Robin by Sabine Pass Liquefaction, LLC (SPL), requesting blanket authorization to SUPPLEMENTARY INFORMATION: This Æ Budget and Planning Update export liquefied natural gas (LNG) information collection request contains: Æ Waste Disposition and Regulatory previously imported into the United (1) OMB No. 1910–0600; (2) Information Reform Update States from foreign sources in an Collection Request Titled: Industrial Æ Public Comment Relations; (3) Type of Review: Renewal; amount up to the equivalent of 500 Æ EM SSAB Chairs’ (4) Purpose: This information is billion cubic feet (Bcf) of natural gas on Recommendation(s) Development required for management oversight of a short-term or spot market basis for a and Discussion two-year period commencing on June 7, the Department of Energy’s Facilities Æ Management Contractors and to ensure EM SSAB Designated Federal 2018. SPL states that the existing that the programmatic and Officer’s Update blanket re-export authorization of its administrative management Public Participation: The EM SSAB affiliate, Cheniere Marketing, LLC, set requirements of the contract are Chairs welcome the attendance of the forth in DOE/FE Order No. 3825 (May managed efficiently and effectively; (5) public at their advisory committee 26, 2016) is scheduled to expire on June Annual Estimated Number of meetings and will make every effort to 6, 2018. SPL seeks authorization to Respondents: 42; (6) Annual Estimated accommodate persons with physical export the LNG from the Sabine Pass Number of Total Responses: 316; (7) disabilities or special needs. If you LNG Terminal owned by Sabine Pass Annual Estimated Number of Burden require special accommodations due to LNG, L.P. and located in Cameron Hours: 4,093; (8) Annual Estimated a disability, please contact David Borak Parish, Louisiana, to any country with Reporting and Recordkeeping Cost at least seven days in advance of the the capacity to import LNG via ocean- Burden: $0. meeting at the phone number listed going carrier and with which trade is above. Written statements may be filed not prohibited by U.S. law or policy. Statutory Authority: 42 U.S.C. 7256; 48 either before or after the meeting with SPL states that it does not seek CFR 970.0370–1. the Designated Federal Officer, David authorization to export any domestically Issued in Washington, DC, on March 14, Borak, at the address or telephone listed produced natural gas or LNG. SPL is 2018. above. Individuals who wish to make requesting this authorization on its own John R. Bashista, oral statements pertaining to agenda behalf and as agent for other parties who Director, Office of Acquisition Management. items should also contact David Borak. hold title to the LNG at the time of [FR Doc. 2018–07994 Filed 4–16–18; 8:45 am] Requests must be received five days export. The Application was filed under BILLING CODE 6450–01–P prior to the meeting and reasonable section 3 of the Natural Gas Act (NGA). provision will be made to include the Additional details can be found in SPL’s presentation in the agenda. The Application, posted on the DOE/FE DEPARTMENT OF ENERGY Designated Federal Officer is website at: https://www.energy.gov/ empowered to conduct the meeting in a sites/prod/files/2018/04/f50/18-35- Environmental Management Site- fashion that will facilitate the orderly LNG.pdf. Protests, motions to intervene, Specific Advisory Board Chairs conduct of business. Individuals notices of intervention, and written AGENCY: Department of Energy (DOE). wishing to make public comment will comments are invited. be provided a maximum of five minutes ACTION: Notice of open meeting. DATES: Protests, motions to intervene or to present their comments. notices of intervention, as applicable, SUMMARY: This notice announces a Minutes: Minutes will be available by requests for additional procedures, and meeting of the Environmental writing or calling David Borak at the written comments are to be filed using Management Site-Specific Advisory address or phone number listed above. procedures detailed in the Public Board (EM SSAB) Chairs. The Federal Minutes will also be available at the Comment Procedures section no later Advisory Committee Act requires that following website: https://energy.gov/ than 4:30 p.m., Eastern time, May 17, public notice of this meeting be em/listings/chairs-meetings. 2018. announced in the Federal Register. Issued at Washington, DC on April 11, ADDRESSES: DATES: Thursday, May 3, 2018, 8:00 2018. Electronic Filing by email: fergas@ a.m.–5:00 p.m. Latanya Butler, hq.doe.gov. ADDRESSES: Holiday Inn Roswell, 3620 Deputy Committee Management Officer. Regular Mail: U.S. Department of North Main Street, Roswell, New [FR Doc. 2018–08001 Filed 4–16–18; 8:45 am] Energy (FE–34), Office of Regulation Mexico 88201. BILLING CODE 6450–01–P and International Engagement, Office of

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Fossil Energy, P.O. Box 44375, respect to the Application will not serve interventions, and comments will also Washington, DC 20026–4375. to make the commenter or protestant a be available electronically by going to Hand Delivery or Private Delivery party to the proceeding, although the following DOE/FE Web address: Services (e.g., FedEx, UPS, etc.): U.S. protests and comments received from http://www.fe.doe.gov/programs/ Department of Energy (FE–34), Office of persons who are not parties will be gasregulation/index.html. Regulation and International considered in determining the Engagement, Office of Fossil Energy, appropriate action to be taken on the Issued in Washington, DC, on April 11, 2018. Forrestal Building, Room 3E–042, 1000 Application. All protests, comments, Independence Avenue SW, Washington, motions to intervene, or notices of Robert Smith, DC 20585. intervention must meet the Deputy Assistant Secretary for Oil and FOR FURTHER INFORMATION CONTACT: requirements specified by the Natural Gas (Acting). Beverly Howard or Larine Moore, U.S. regulations in 10 CFR part 590. [FR Doc. 2018–07894 Filed 4–16–18; 8:45 am] Department of Energy (FE–34), Office Filings may be submitted using one of BILLING CODE 6450–01–P of Regulation and International the following methods: (1) Emailing the Engagement, Office of Fossil Energy, filing to [email protected], with FE Forrestal Building, Room 3E–042, Docket No. 18–35–LNG in the title line; DEPARTMENT OF ENERGY 1000 Independence Avenue SW, (2) mailing an original and three paper Washington, DC 20585, (202) 586– copies of the filing to the Office of Federal Energy Regulatory Regulation and International 9387; (202) 586–9478. Commission Engagement at the address listed in Cassandra Bernstein or R.J. Colwell, ADDRESSES; or (3) hand delivering an U.S. Department of Energy Office of Notice of Commissioner Attendance at original and three paper copies of the the Assistant General Counsel for House Committee on Energy and filing to the Office of Regulation and Electricity and Fossil Energy, Commerce Hearing International Engagement at the address Forrestal Building, Room 6D–033, listed in ADDRESSES. All filings must 1000 Independence Ave. SW, The Federal Energy Regulatory include a reference to FE Docket No. Washington, DC 20585, (202) 586– Commission (Commission) hereby gives 18–35–LNG. Please Note: If submitting 9793 or 586–8499. notice that members of the Commission a filing via email, please include all may attend the following hearing: SUPPLEMENTARY INFORMATION: related documents and attachments The House Committee on Energy and DOE/FE Evaluation (e.g., exhibits) in the original email correspondence. Please do not include Commerce will be holding a general The Application will be reviewed any active hyperlinks or password oversight hearing entitled ‘‘Oversight of pursuant to section 3 of the NGA, 15 protection in any of the documents or the Federal Energy Regulatory U.S.C. 717b. In reviewing this attachments related to the filing. All Commission and the FY2019 Budget.’’ Application, DOE will consider electronic filings submitted to DOE All five Commission members may domestic need for the gas, as well as any must follow these guidelines to ensure testify at the hearing. other issues determined to be that all documents are filed in a timely 2123 Rayburn House Office Building, appropriate, including whether the manner. Any hardcopy filing submitted Washington, DC arrangement is consistent with DOE’s greater in length than 50 pages must policy of promoting competition in the also include, at the time of the filing, a April 17, 2018 at 10:00 a.m. eastern time marketplace by allowing commercial digital copy on disk of the entire parties to freely negotiate their own Further information regarding this submission. hearing may be found at: https:// trade arrangements. Parties that may A decisional record on the energycommerce.house.gov/hearings/. oppose this application should Application will be developed through comment in their responses on these responses to this notice by parties, The discussions at the hearing, which issues. including the parties’ written comments are open to the public, may address The National Environmental Policy and replies thereto. Additional issues relevant to Commission Act (NEPA), 42 U.S.C. 4321 et seq., procedures will be used as necessary to proceedings. requires DOE to give appropriate achieve a complete understanding of the For further information, please consideration to the environmental facts and issues. If an additional contact Jehmal Hudson, 202–502–6142, effects of its proposed decisions. No procedure is scheduled, notice will be or [email protected]. final decision will be issued in this provided to all parties. If no party proceeding until DOE has met its NEPA requests additional procedures, a final Dated: April 10, 2018. responsibilities. Opinion and Order may be issued based Kimberly D. Bose, on the official record, including the Public Comment Procedures Secretary. Application and responses filed by [FR Doc. 2018–07925 Filed 4–16–18; 8:45 am] In response to this Notice, any person parties pursuant to this notice, in may file a protest, comments, or a accordance with 10 CFR 590.316. BILLING CODE 6717–01–P motion to intervene or notice of The Application is available for intervention, as applicable. Interested inspection and copying in the Office of parties will be provided 30 days from Regulation and International the date of publication of this Notice in Engagement docket room, Room 3E– which to submit comments, protests, 042, 1000 Independence Avenue SW, motions to intervene, or notices of Washington, DC 20585. The docket intervention. room is open between the hours of 8:00 Any person wishing to become a party a.m. and 4:30 p.m., Monday through to the proceeding must file a motion to Friday, except Federal holidays. The intervene or notice of intervention. The Application and any filed protests, filing of comments or a protest with motions to intervene or notice of

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DEPARTMENT OF ENERGY Commission noted that each RTO and In an order issued March 23, 2018 in ISO may fulfill its obligations under Docket No. ER18–370–000,9 the Federal Energy Regulatory Order No. 890 by delegating certain Commission found that protesters in Commission planning activities to, or otherwise that proceeding raised important relying on, its transmission owning questions that relate to the processes by [Docket No. AD18–12–000; Docket No. 10 EL17–45–000; Docket No. ER18–370–000] members, provided that the rights and which all CAISO PTOs determine responsibilities of all parties are clearly which transmission-related Supplemental Notice of Technical stated in the RTO’s/ISO’s OATT.3 The maintenance and compliance activities, Conference; Transmission Planning Commission also explained that, in including, but not limited to, Within the California Independent many cases, RTO/ISO transmission transmission-related capital additions, System Operator Corporation; planning processes may focus must be submitted to CAISO’s TPP.11 In California Public Utilities Commission, principally on regional problems and that order, the Commission directed Northern California Power Agency, solutions, while local planning issues Commission staff to convene a technical City and County of San Francisco, may be addressed by individual conference to explore these issues. State Water Contractors, Transmission transmission owners.4 Noting that these Given the background provided Agency of Northern California v. local transmission planning issues may herein, participants should be prepared Pacific Gas and Electric Company, be critically important to transmission to discuss the following: Southern California Edison Company customers, the Commission stated that 1. Please define and describe what transmission owners must, to the extent constitutes transmission-related As announced in the Notice of that they perform transmission planning maintenance and compliance activities/ Technical Conference issued on March within an RTO or ISO, comply with facilities. Please provide specific 23, 2018, the Federal Energy Regulatory Order No. 890 as well.5 examples and an explanation regarding Commission staff will hold a technical In a series of orders issued between how it is determined that such an conference on May 1, 2018, at the 2008 and 2010, the Commission example falls into the category of Commission’s headquarters at 888 First accepted CAISO’s TPP as consistent transmission-related maintenance and Street NE, Washington, DC 20426, with the requirements of Order No. compliance activities/facilities. How between 9:00 a.m. and 4:00 p.m. 890.6 As is relevant here, in an order does each CAISO PTO identify the need (Eastern Time). The purpose of the issued on May 21, 2009, the for transmission-related maintenance technical conference is to explore the Commission found that ‘‘the local and compliance activities/facilities and processes used by participating planning activities conducted by the decide which activities/facilities to transmission owners (PTOs) in the participating transmission owners [in undertake? California Independent System Operator CAISO] are reasonable and the process, 2. How does each CASIO PTO Corporation (CAISO) to determine as set forth in the [CAISO] tariff and determine if actions taken to maintain, which transmission-related business practice manual, is repair, or replace facilities should be maintenance and compliance activities/ transparent.’’ 7 However, more recently, considered and reviewed through facilities, including, but not limited to, a number of interested parties have CAISO’s TPP? Which transmission- transmission-related capital additions, raised concerns regarding the lack of related maintenance and compliance are subject to the CAISO Transmission opportunity for stakeholder review of activities/facilities are submitted for 1 Planning Process (TPP). transmission-related maintenance and consideration and review through In Order No. 890, the Commission compliance activities, including, but not CAISO’s TPP and which activities or required all public utility transmission limited to, certain transmission-related transmission facilities are considered providers, including regional capital additions, which CAISO PTOs and reviewed solely by PTOs? Please transmission organizations (RTOs) and do not submit to CAISO’s TPP.8 explain. independent system operators (ISOs), to 3. Are there criteria or parameters that revise their open access transmission openness; (3) transparency; (4) information each CAISO PTO uses to determine tariffs (OATTs) to incorporate a exchange; (5) comparability; (6) dispute resolution; which transmission-related transmission planning process that (7) regional participation; (8) economic planning maintenance and compliance activities/ satisfied nine transmission planning studies; and (9) cost allocation for new projects. facilities to submit to CAISO for 3 principles to limit the opportunities for Order No. 890–A, FERC Stats. & Regs. ¶ 31,261 consideration and review through at P 175. undue discrimination and 4 Order No. 890, FERC Stats. & Regs. ¶ 31,241 at CAISO’s TPP? What factors are anticompetitive conduct in transmission P 440. considered (e.g., cost, voltage level, service.2 In Order No. 890–A, the 5 Id. length, rating)? Please explain. 6 See Cal. Indep. Sys. Operator Corp., 123 FERC 4. Do CAISO’s tariff or BPMs provide 1 Commission staff is using ‘‘transmission-related ¶ 61,283 (2008), order denying reh’g and on guidance and clarity to CAISO PTOs maintenance and compliance activities/facilities’’ compliance filing, 127 FERC ¶ 61,172 (2009), order regarding what transmission-related as a term intended to encompass the activities, on compliance filing, 130 FERC ¶ 61,048 (2010). facilities, and/or projects at issue in the proceedings 7 Cal. Indep. Sys. Operator Corp., 127 FERC ¶ maintenance and compliance activities/ included in this notice. The Parties in these 61,172 at P 118. facilities must be considered and proceedings do not use a common definition or 8 See, e.g., Cal. Pub. Utils. Comm’n, et al. v. reviewed through CAISO’s TPP? If so, phrase that is set out in any tariff or business Pacific Gas & Elec. Co., Complaint, Docket No. please list the relevant sections. practice manual (BPM). Staff’s intent for the EL17–45–000 (filed Feb. 2, 2017) (asserting that technical conference is to include a broad category Pacific Gas & Electric Co. is in violation of Order of transmission-related activities and facilities. This No. 890 because it conducts more than 80 percent 9 S. Cal. Edison, 162 FERC ¶ 61,264 (2018). includes any work on the transmission system, of its transmission planning on an internal basis 10 Although the concerns protesters raised in including, but not limited to, transmission-related without stakeholder review); Cal. Pub. Utils. Docket No. ER18–370–000 relate specifically to maintenance, repair, replacement, or compliance Comm’n Dec. 22, 2017 Protest, Docket No. ER18– SoCal Edison, the Commission found that the activities and associated facilities, as well as 370–000 (protesting Southern California Edison questions raised were also applicable to the transmission-related capital additions. Co.’s filing of an amendment to its Transmission processes that other CAISO PTOs use to identify 2 Order No. 890, FERC Stats. & Regs. ¶ 31,241 at Owner Tariff to create an annual Transmission which transmission-related maintenance and PP 426, 435; see Order No. 890–A, FERC Stats. & Maintenance and Compliance Review process on compliance activities/facilities must be submitted Regs. ¶ 31,261 at P 171. These transmission the basis that the proposed process does not meet to CAISO’s TPP. Id. P 24. planning principles are: (1) Coordination; (2) the requirements of Order No. 890). 11 Id. P 23.

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5. For transmission-related stakeholders to review and provide requested. Those wishing this service maintenance and compliance activities/ input on cost and other factors. Please should register at the link provided and facilities that may enhance the also describe the timeframe for specify the telephone line option. transmission system (such as additions providing this input. The conference will consist of that increase line ratings or extend the 11. How does each CAISO PTO questions posed by Commission staff useful life of a transmission asset), how decide whether to pursue reliability- and responses provided by CAISO, the does each CAISO PTO determine related transmission-related CAISO PTOs, and complainants. There whether this maintenance or maintenance and compliance activities/ may also be an opportunity for follow- compliance activity/facility should be facilities that are not required by the up questions and comments from considered and reviewed as part of North American Electric Reliability attendees during those discussions. The CAISO’s TPP? Where are the criteria or Corporation (NERC), Western Electricity specific agenda and procedures to be parameters related to this determination Coordinating Council (WECC), or other followed at the conference will be documented or otherwise made regulatory entities? What criteria or announced by staff at the opening of the available? parameters are used by each CAISO conference. 6. When deciding whether to submit PTO to make this decision? Where are The technical conference will be a transmission-related maintenance and such criteria or parameters documented transcribed, and the transcript will be compliance activity/facility for or otherwise made available? available immediately for a fee from Ace consideration and review through 12. Is there a difference between (a) Reporting Company ((202) 347–3700). CAISO’s TPP, does each CAISO PTO the process through which each CAISO Commission conferences are differentiate between transmission- PTO pursues solutions to transmission- accessible under section 508 of the related maintenance and compliance related maintenance and compliance Rehabilitation Act of 1973. For activities/facilities that require activities/facilities that arise from NERC accessibility accommodations, please immediate action (e.g., non-functioning and WECC reliability standards or send an email to [email protected] transmission infrastructure) and those reliability standards established by or call toll free (866) 208–3372 (voice) that do not require immediate action other regulatory entities, and (b) the or (202) 502–8659 (TTY), or send a fax and may be addressed over a longer process through which each CAISO PTO to (202) 208–2106 with the required timeframe? Please explain how this pursues solutions to other transmission- accommodations. differentiation is decided. Are there related maintenance and compliance Following the technical conference, criteria or parameters used by the activities/facilities? If so, please explain all interested persons are invited to file CAISO PTO to make this (1) the difference between the two initial and reply post-technical differentiation? If so, where are such processes and (2) elaborate on the conference comments on the topics criteria or parameters documented or reasons for the differences. discussed during the technical 13. Please explain how costs otherwise made available? conference, including the questions 7. Is there a process through which associated with transmission-related listed above. Commenters may reference each CAISO PTO evaluates whether a maintenance and compliance activities/ material previously filed in this docket, transmission-related maintenance and facilities developed outside of the including the technical conference compliance activity/facility that was not CAISO TPP are reflected in wholesale transcript, but are encouraged to avoid initially submitted to CAISO’s TPP and retail transmission rates. repetition or replication of previous should be transitioned into the CAISO 14. How does each CAISO PTO material. Initial comments are due on or TPP for consideration and review? If so, determine whether transmission-related before May 31, 2018; reply comments please describe that process, including maintenance, repair, or replacement are due on or before June 15, 2018. what criteria or parameters are activities/facilities should be capitalized Initial comments should not exceed 15 considered in reaching the conclusion or expensed as operations and pages, and reply comments should not to transition to CAISO’s TPP. Also, maintenance costs? Please explain. exceed 10 pages. The written comments please explain where such criteria or 15. What recommendations do you will be included in the formal record of parameters are documented or have for each CAISO PTO to increase the proceeding, which, together with the otherwise made available. the transparency of the process for 8. What information does each CAISO stakeholders and others with respect to record developed to date, will form the PTO submit to CAISO (during Phase I of the CAISO PTOs’ planning for basis for further Commission action. the TPP) concerning the transmission- transmission-related maintenance and For Further Information, Please related maintenance and compliance compliance activities/facilities? How Contact Individuals Identified for Each activities/facilities planned outside of would these recommendations affect the Topic: CAISO’s TPP? Please explain what type CAISO PTOs? Would such effects be Technical Information: Laura Switzer, of information is provided and what manageable? If not, why not? If changes Office of Energy Markets Regulation, level of detail is included. to increase transparency could be made, Federal Energy Regulatory 9. What is the process through which should they be the same for each CAISO Commission, 888 First Street NE, each CAISO PTO performs transmission PTO? Washington, DC 20426, (202) 502– planning activities outside of CAISO’s The technical conference will be led 6231, [email protected] TPP? Please describe that process in by Commission staff, and is open to the Legal Information for Docket Nos. detail. public. All interested persons may AD18–12–000 and EL17–45–000: 10. Are there processes for attend the conference, and registration Linda Kizuka, Office of the General stakeholders to review and provide is not required. However, in-person Counsel, Federal Energy Regulatory input on transmission-related attendees are encouraged to register on- Commission, 888 First Street NE, maintenance and compliance activities/ line by April 20, 2018 at https:// Washington, DC 20426, (202) 502– facilities, including transmission-related www.ferc.gov/whats-new/registration/ 8773, [email protected] capital additions, not included in 05-01-18-form.asp. This event will NOT Legal Information for Docket Nos. CAISO’s TPP? If so, please describe be webcast. However, for those who AD18–12–000 and ER18–370–000: these processes in detail, including cannot attend in person, we will Susanna Ehrlich, Office of the General whether there is an opportunity for provide a listen-only telephone line, if Counsel, Federal Energy Regulatory

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Commission, 888 First Street NE, Any person desiring to intervene or Persons unable to file electronically Washington, DC 20426, (202) 502– protest in any of the above proceedings should submit an original and 5 copies 6260, [email protected] must file in accordance with Rules 211 of the protest or intervention to the Logistical Information: Sarah McKinley, and 214 of the Commission’s Federal Energy Regulatory Commission, Office of External Affairs, Federal Regulations (18 CFR 385.211 and 888 First Street NE, Washington, DC Energy Regulatory Commission, 888 385.214) on or before 5:00 p.m. Eastern 20426. First Street NE, Washington, DC time on the specified comment date. This filing is accessible on-line at 20426, (202) 502–8368, Protests may be considered, but http://www.ferc.gov, using the [email protected]. intervention is necessary to become a ‘‘eLibrary’’ link and is available for Dated: April 10, 2018. party to the proceeding. review in the Commission’s Public Kimberly D. Bose, eFiling is encouraged. More detailed Reference Room in Washington, DC. information relating to filing There is an ‘‘eSubscription’’ link on the Secretary. requirements, interventions, protests, website that enables subscribers to [FR Doc. 2018–07923 Filed 4–16–18; 8:45 am] service, and qualifying facilities filings receive email notification when a BILLING CODE 6717–01–P can be found at: http://www.ferc.gov/ document is added to a subscribed docs-filing/efiling/filing-req.pdf. For docket(s). For assistance with any FERC other information, call (866) 208–3676 Online service, please email DEPARTMENT OF ENERGY (toll free). For TTY, call (202) 502–8659. [email protected], or call Federal Energy Regulatory Dated: April 11, 2018. (866) 208–3676 (toll free). For TTY, call Commission Nathaniel J. Davis, Sr., (202) 502–8659. Comment Date: 5:00 p.m. Eastern time Deputy Secretary. Combined Notice of Filings on May 7, 2018. [FR Doc. 2018–07998 Filed 4–16–18; 8:45 am] Dated: April 10, 2018. Take notice that the Commission has BILLING CODE 6717–01–P received the following Natural Gas Kimberly D. Bose, Pipeline Rate and Refund Report filings: Secretary. DEPARTMENT OF ENERGY [FR Doc. 2018–07927 Filed 4–16–18; 8:45 am] Filings Instituting Proceedings BILLING CODE 6717–01–P Docket Numbers: RP18–228–001. Federal Energy Regulatory Applicants: Rockies Express Pipeline Commission LLC [Docket No. OR18–20–000] DEPARTMENT OF ENERGY Description: Compliance filing Compliance to RP18–228 Monthly Notice of Petition for Declaratory Federal Energy Regulatory FL&U Postings to be effective 4/19/2018. Order; Marathon Pipe Line LLC, MPLX Commission Filed Date: 4/10/18. Ozark Pipe Line LLC [Docket No. CP18–89–000] Accession Number: 20180410–5148. Comments Due: 5 p.m. ET 4/16/18. Take notice that on April 6, 2018, Notice of Intent To Prepare an pursuant to Rule 207(a)(2) of the Federal Docket Numbers: RP18–694–000. Environmental Assessment for the Energy Regulatory Commission’s Applicants: Rockies Express Pipeline Proposed Empire Pipeline, Inc. Empire (Commission) Rules of Practice and LLC.. North Project and Request for Procedure, 18 CFR 385.207(a)(2) (2017), Description: § 4(d) Rate Filing: Errata Comments on Environmental Issues Marathon Pipe Line LLC and MPLX to RP18–228, Seneca Lateral to be Ozark Pipe Line LLC filed a joint The staff of the Federal Energy effective 4/19/2018. petition for a declaratory order seeking Regulatory Commission (FERC or Filed Date: 4/10/18. approval of certain terms and conditions Commission) will prepare an Accession Number: 20180410–5151. in the transportation services agreement, environmental assessment (EA) that will Comments Due: 5 p.m. ET 4/16/18. related to a joint expansion project, all discuss the environmental impacts of Docket Numbers: RP18–695–000. as more fully explained in the petition. the Empire North Project involving Applicants: Transcontinental Gas Any person desiring to intervene or to construction and operation of facilities Pipe Line Company. protest this filing must file in by Empire Pipeline, Inc. (Empire) in Description: § 4(d) Rate Filing: Non- accordance with Rules 211 and 214 of Tioga County, Pennsylvania and in Conforming—Dalton (Cartersville, GA) the Commission’s Rules of Practice and Ontario, Yates, Schuyler, Chemung, and to be effective 6/1/2018. Procedure (18 CFR 385.211, 385.214). Steuben Counties, New York. The Filed Date: 4/10/18. Protests will be considered by the Commission will use this EA in its Accession Number: 20180410–5199. Commission in determining the decision-making process to determine Comments Due: 5 p.m. ET 4/23/18. appropriate action to be taken, but will whether the project is in the public Docket Numbers: RP18–696–000. not serve to make protestants parties to convenience and necessity. Applicants: El Paso Natural Gas the proceeding. Any person wishing to This notice announces the opening of Company, L.L.C. become a party must file a notice of the scoping process the Commission Description: § 4(d) Rate Filing: intervention or motion to intervene, as will use to gather input from the public Negotiated Rate Update Filing (TGS Apr appropriate. Such notices, motions, or and interested agencies on the project. 18) to be effective 4/11/2018. protests must be filed on or before the You can make a difference by providing Filed Date: 4/10/18. comment date. Anyone filing a motion us with your specific comments or Accession Number: 20180410–5221. to intervene or protest must serve a copy concerns about the project. Your Comments Due: 5 p.m. ET 4/23/18. of that document on the Petitioner. comments should focus on the potential The filings are accessible in the The Commission encourages environmental effects, reasonable Commission’s eLibrary system by electronic submission of protests and alternatives, and measures to avoid or clicking on the links or querying the interventions in lieu of paper using the lessen environmental impacts. Your docket number. ‘‘eFiling’’ link at http://www.ferc.gov. input will help the Commission staff

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determine what issues they need to (2) You can file your comments Land Requirements for Construction evaluate in the EA. To ensure that your electronically by using the eFiling Construction of the proposed facilities comments are timely and properly feature on the Commission’s website would disturb about 50.4 acres of land recorded, please send your comments so (www.ferc.gov) under the link to for the aboveground facilities. Following that the Commission receives them in Documents and Filings. With eFiling, construction, Empire would maintain Washington, DC on or before May 10, you can provide comments in a variety about 17.5 acres for permanent 2018. of formats by attaching them as a file operation of the project’s facilities; the If you sent comments on this project with your submission. New eFiling remaining acreage would be restored to the Commission before the opening of users must first create an account by and revert to former uses. this docket on February 16, 2018, you clicking on ‘‘eRegister.’’ If you are filing will need to file those comments in a comment on a particular project, The EA Process Docket No. CP18–89–000 to ensure they please select ‘‘Comment on a Filing’’ as The National Environmental Policy are considered as part of this the filing type; or Act (NEPA) requires the Commission to proceeding. (3) You can file a paper copy of your take into account the environmental This notice is being sent to the comments by mailing them to the impacts that could result from an action Commission’s current environmental following address. Be sure to reference whenever it considers the issuance of a mailing list for this project. State and the project docket number (CP18–89– Certificate of Public Convenience and local government representatives should 000) with your submission: Kimberly D. Necessity. NEPA also requires us 2 to notify their constituents of this Bose, Secretary, Federal Energy discover and address concerns the proposed project and encourage them to Regulatory Commission, 888 First Street public may have about proposals. This comment on their areas of concern. NE, Room 1A, Washington, DC 20426. process is referred to as ‘‘scoping.’’ The main goal of the scoping process is to If you are a landowner receiving this Summary of the Proposed Project notice, a pipeline company focus the analysis in the EA on the representative may contact you about Empire proposes to construct and important environmental issues. By this the acquisition of an easement to operate gas compression facilities in notice, the Commission requests public construct, operate, and maintain the Tioga County, Pennsylvania and in comments on the scope of the issues to proposed facilities. The company would Ontario, New York. The Empire North address in the EA. We will consider all seek to negotiate a mutually acceptable Project would provide about 205 million filed comments during the preparation agreement. However, if the Commission cubic feet per day of incremental firm of the EA. approves the project, that approval transportation capacity. The Empire In the EA we will discuss impacts that conveys with it the right of eminent North Project would consist of the could occur as a result of the domain. Therefore, if easement following facilities: construction and operation of the negotiations fail to produce an • A new 21,000 horsepower (hp) proposed project under these general agreement, the pipeline company could compressor station in Jackson headings: • Geology and soils; initiate condemnation proceedings Township, Tioga County, Pennsylvania; • water resources, fisheries, and • where compensation would be a new 32,000 hp compressor station wetlands; determined in accordance with state in the Town of Farmington, Ontario • vegetation and wildlife; law. County, New York; • endangered and threatened species; Empire provided landowners with a • modifications of the existing • cultural resources; fact sheet prepared by the FERC entitled regulator valves and station piping and • land use; ‘‘An Interstate Natural Gas Facility On installation of metering facilities at the • socioeconomics; My Land? What Do I Need To Know?’’ • air quality and noise; existing New Victor Regulator Station in • This fact sheet addresses a number of Ontario County, New York; public safety; and • cumulative impacts. typically asked questions, including the • minor modifications to the existing use of eminent domain and how to We will also evaluate reasonable Jackson Meter and Regulator Station in alternatives to the proposed project or participate in the Commission’s Jackson Township, Tioga County, proceedings. It is also available for portions of the project, and make Pennsylvania; and recommendations on how to lessen or viewing on the FERC website • upgrading the maximum allowable (www.ferc.gov). avoid impacts on the various resource operating pressure of the Empire areas. Public Participation Connector Pipeline (ECP) from 1,290 The EA will present our independent pounds per square inch gauge (psig) to analysis of the issues. The EA will be For your convenience, there are three 1,440 psig. The ECP is an existing 76.6- methods you can use to submit your available in the public record through mile-long, 24-inch-diameter pipeline eLibrary. Depending on the comments comments to the Commission. The that runs from Victor, New York to Commission encourages electronic filing received during the scoping process, we Corning, New York in in Ontario, Yates, may also publish and distribute the EA of comments and has expert staff Schuyler, Chemung, and Steuben to the public for an allotted comment available to assist you at (202) 502–8258 Counties, New York. period. We will consider all comments or [email protected]. Please The general location of the project on the EA before making our carefully follow these instructions so facilities is shown in appendix A.1 recommendations to the Commission. that your comments are properly To ensure we have the opportunity to recorded. 1 consider and address your comments, (1) You can file your comments The appendices referenced in this notice will not appear in the Federal Register. Copies of please carefully follow the instructions electronically using the eComment appendices were sent to all those receiving this in the Public Participation section, feature on the Commission’s website notice in the mail and are available at www.ferc.gov beginning on page 2. (www.ferc.gov) under the link to using the link called ‘‘eLibrary’’ or from the Commission’s Public Reference Room, 888 First Documents and Filings. This is an easy Street NE, Washington, DC 20426, or call (202) 502– 2 ‘‘We,’’ ‘‘us,’’ and ‘‘our’’ refer to the method for submitting brief, text-only 8371. For instructions on connecting to eLibrary, environmental staff of the Commission’s Office of comments on a project; refer to the last page of this notice. Energy Projects.

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With this notice, we are asking project purposes, or who own homes In addition, the Commission offers a agencies with jurisdiction by law and/ within certain distances of aboveground free service called eSubscription which or special expertise with respect to the facilities, and anyone who submits allows you to keep track of all formal environmental issues of this project to comments on the project. We will issuances and submittals in specific formally cooperate with us in the update the environmental mailing list as dockets. This can reduce the amount of preparation of the EA.3 Agencies that the analysis proceeds to ensure that we time you spend researching proceedings would like to request cooperating send the information related to this by automatically providing you with agency status should follow the environmental review to all individuals, notification of these filings, document instructions for filing comments organizations, and government entities summaries, and direct links to the provided under the Public Participation interested in and/or potentially affected documents. Go to www.ferc.gov/docs- section of this notice. by the proposed project. filing/esubscription.asp. If we publish and distribute the EA, Consultations Under Section 106 of the Finally, public sessions or site visits copies of the EA will be sent to the National Historic Preservation Act will be posted on the Commission’s environmental mailing list for public calendar located at www.ferc.gov/ In accordance with the Advisory review and comment. If you would EventCalendar/EventsList.aspx along Council on Historic Preservation’s prefer to receive a paper copy of the with other related information. implementing regulations for section document instead of the CD version or 106 of the National Historic would like to remove your name from Dated: April 10, 2018. Preservation Act, we are using this the mailing list, please return the Kimberly D. Bose, notice to initiate consultation with the attached Information Request Secretary. applicable State Historic Preservation (appendix 2). [FR Doc. 2018–07924 Filed 4–16–18; 8:45 am] Offices (SHPO), and to solicit their BILLING CODE 6717–01–P views and those of other government Becoming an Intervenor agencies, interested Indian tribes, and In addition to involvement in the EA the public on the project’s potential scoping process, you may want to DEPARTMENT OF ENERGY effects on historic properties.4 We will become an ‘‘intervenor’’ which is an define the project-specific Area of official party to the Commission’s Federal Energy Regulatory Potential Effects (APE) in consultation proceeding. Intervenors play a more Commission with the SHPOs as the project develops. formal role in the process and are able On natural gas facility projects, the APE to file briefs, appear at hearings, and be Sunshine Act Meeting Notice at a minimum encompasses all areas heard by the courts if they choose to The following notice of meeting is subject to ground disturbance (examples appeal the Commission’s final ruling. published pursuant to section 3(a) of the include construction right-of-way, An intervenor formally participates in government in the Sunshine Act (Pub. contractor/pipe storage yards, the proceeding by filing a request to L. 94–409), 5 U.S.C. 552b: compressor stations, and access roads). intervene. Instructions for becoming an Our EA for this project will document intervenor are in the ‘‘Document-less AGENCY HOLDING MEETING: Federal our findings on the impacts on historic Intervention Guide’’ under the ‘‘e-filing’’ Energy Regulatory Commission. properties and summarize the status of link on the Commission’s website. DATE AND TIME: April 19, 2018, 10:00 consultations under section 106. Motions to intervene are more fully a.m. Environmental Mailing List described at http://www.ferc.gov/ resources/guides/how-to/intervene.asp. PLACE: Room 2C, 888 First Street NE, The environmental mailing list Washington, DC 20426. Additional Information includes federal, state, and local STATUS: Open. government representatives and Additional information about the agencies; elected officials; Native project is available from the MATTERS TO BE CONSIDERED: Agenda. American Tribes; other interested Commission’s Office of External Affairs, * Note—Items listed on the agenda parties; and local libraries and at (866) 208–FERC, or on the FERC may be deleted without further notice. newspapers. This list also includes all website at www.ferc.gov using the CONTACT PERSON FOR MORE INFORMATION: affected landowners (as defined in the ‘‘eLibrary’’ link. Click on the eLibrary Kimberly D. Bose, Secretary, Telephone Commission’s regulations) who are link, click on ‘‘General Search’’ and (202) 502–8400. potential right-of-way grantors, whose enter the docket number, excluding the For a recorded message listing items property may be used temporarily for last three digits in the Docket Number struck from or added to the meeting, call field (i.e., CP18–89). Be sure you have (202) 502–8627. 3 The Council on Environmental Quality selected an appropriate date range. For regulations addressing cooperating agency This is a list of matters to be considered responsibilities are at Title 40, Code of Federal assistance, please contact FERC Online Support at [email protected] by the Commission. It does not include a Regulations, Part 1501.6. listing of all documents relevant to the items 4 The Advisory Council on Historic Preservation’s or toll free at (866) 208–3676, or for on the agenda. All public documents, regulations are at Title 36, Code of Federal TTY, contact (202) 502–8659. The however, may be viewed on line at the Regulations, Part 800. Those regulations define eLibrary link also provides access to the historic properties as any prehistoric or historic Commission’s website at http:// district, site, building, structure, or object included texts of formal documents issued by the ferc.capitolconnection.org/ sing the eLibrary in or eligible for inclusion in the National Register Commission, such as orders, notices, link, or may be examined in the of Historic Places. and rulemakings. Commission’s Public Reference Room.

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1042ND—MEETING Regular Meeting [April 19, 2018, 10:00 a.m.]

Item No. Docket No. Company

Administrative

A–1 ...... AD18–1–000 ...... Agency Administrative Matters. A–2 ...... AD18–2–000 ...... Customer Matters, Reliability, Security and Market Operations. A–3 ...... AD06–3–000 ...... Market Update.

Electric

E–1 ...... RM17–2–000 ...... Uplift Cost Allocation and Transparency in Markets Operated by Regional Trans- mission Organizations and Independent System Operators. E–2 ...... RM17–8–000 ...... Reform of Generator Interconnection Procedures and Agreements. E–3 ...... RM17–11–000 ...... Revised Critical Infrastructure Protection Reliability Standard CIP–003–7—Cyber Secu- rity—Security Management Controls. E–4 ...... Omitted. E–5 ...... ER18–459–000, ER18–460–000 ...... PJM Interconnection L.L.C. and Ohio Valley Electric Corporation. E–6 ...... ER17–1016–001 ...... PJM Interconnection, L.L.C. E–7 ...... ER17–219–002 ...... PacifiCorp. E–8 ...... ER17–2229–001 ...... Southwest Power Pool, Inc.

Hydro

H–1 ...... P–12715–013 ...... Fairlawn Hydroelectric Company, LLC. H–2 ...... P–785–034 ...... Consumers Energy Company. H–3 ...... P–14856–001 ...... America First Hydro LLC.

Certificates

C–1 ...... PL18–1–000 ...... Certification of New Interstate Natural Gas Facilities. C–2 ...... CP17–469–000 ...... WBI Energy Transmission, Inc. C–3 ...... CP16–20–001 ...... High Island Offshore System, LLC. C–4 ...... CP14–497–001 ...... Dominion Transmission, Inc. C–5 ...... CP15–77–001 ...... Tennessee Gas Pipeline Company, L.L.C. C–6 ...... CP15–148–001 ...... Tennessee Gas Pipeline Company, L.L.C.

Dated: April 12, 2018. DEPARTMENT OF ENERGY Wheelabrator Saugus Inc., Wheelabrator Nathaniel J. Davis, Sr., Shasta Energy Company Inc., Deputy Secretary. Federal Energy Regulatory Wheelabrator Westchester, L.P., Commission A free webcast of this event is available Cameron Ridge, LLC, Cameron Ridge II, LLC, Coachella Wind, LLC, DifWind through http://ferc.capitolconnection.org/. Combined Notice of Filings #1 Anyone with internet access who desires to Farms Limited I, DifWind Farms view this event can do so by navigating to Take notice that the Commission Limited II, DifWind Farms Limited V, www.ferc.gov’s Calendar of Events and received the following electric rate DifWind Farms LTD VI, EUI Affiliate locating this event in the Calendar. The event filings: LLC, Oak Creek Wind Power, LLC, ON will contain a link to its webcast. The Capitol Wind Energy LLC, Pacific Crest Power, Docket Numbers: ER13–1485–009; LLC, Ridgetop Energy, LLC, San Connection provides technical support for ER10–1992–018; ER10–3230–009; the free webcasts. It also offers access to this Gorgonio Westwinds II, LLC, San ER10–3232–008; ER10–3237–009; event via television in the DC area and via Gorgonio Westwinds II—Windustries, phone bridge for a fee. If you have any ER10–3239–009; ER10–3240–009; LLC, Terra-Gen Energy Services, LLC, questions, visit http:// ER10–3251–011; ER10–3253–009; Terra-Gen Mojave Windfarms, LLC, TGP ferc.capitolconnection.org/ or contact Danelle ER13–1586–012; ER14–1777–008; Energy Management, LLC, Victory Springer or David Reininger at 703–993– ER14–2382–011; ER14–2871–011; Garden Phase IV, LLC, Voyager Wind I, 3100. ER15–110–010; ER15–2722–005; ER15– LLC, Voyager Wind II, LLC, VPI Immediately following the conclusion of 463–010; ER15–621–010; ER15–622– Enterprises, LLC. the Commission Meeting, a press briefing 010; ER16–1129–004; ER16–1130–004; Description: Notice of Change in will be held in the Commission Meeting ER16–1131–004; ER16–1132–004; Status of the ECP MBR Sellers. Room. Members of the public may view this ER16–182–006; ER16–72–006; ER16– Filed Date: 4/9/18. briefing in the designated overflow room. 902–002; ER17–1574–001; ER17–1785– Accession Number: 20180409–5338. This statement is intended to notify the 001; ER17–47–003; ER17–48–003; Comments Due: 5 p.m. ET 4/30/18. public that the press briefings that follow ER18–47–001 Docket Numbers: ER14–1619–004. Commission meetings may now be viewed Applicants: Wheelabrator Baltimore, Applicants: Cottonwood Energy remotely at Commission headquarters, but L.P., Wheelabrator Bridgeport, L.P., Company LP. will not be telecast through the Capitol Wheelabrator Falls Inc., Wheelabrator Description: Compliance filing: Connection service. Frackville Energy Company Inc., Informational Filing Regarding [FR Doc. 2018–08082 Filed 4–13–18; 11:15 am] Wheelabrator North Andover Inc., Upstream Change in Control to be BILLING CODE 6717–01–P Wheelabrator Portsmouth Inc., effective N/A.

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Filed Date: 4/11/18. Filed Date: 4/9/18. DEPARTMENT OF ENERGY Accession Number: 20180411–5076. Accession Number: 20180409–5339. Federal Energy Regulatory Comments Due: 5 p.m. ET 5/2/18. Comments Due: 5 p.m. ET 4/30/18. Docket Numbers: ER14–2080–001. Commission Docket Numbers: ER18–1341–000. Applicants: Louisiana Generating [Docket No. ER18–1321–000] LLC. Applicants: Virginia Electric and Description: Compliance filing: Power Company, PJM Interconnection, Calpine Mid-Merit II, LLC; Informational Filings Regarding L.L.C. Supplemental Notice That Initial Upstream Change in Control to be Description: § 205(d) Rate Filing: Market-Based Rate Filing Includes effective N/A. VEPCO submits revisions to OATT, Request for Blanket Section 204 Filed Date: 4/11/18. Attachment H–16C re: OPEB expense Authorization Accession Number: 20180411–5075. for 2017 to be effective 6/15/2018. This is a supplemental notice in the Comments Due: 5 p.m. ET 5/2/18. Filed Date: 4/11/18. above-referenced proceeding of Calpine Docket Numbers: ER15–502–002. Accession Number: 20180411–5087. Mid-Merit II, LLC’s application for Applicants: Bayou Cove Peaking Comments Due: 5 p.m. ET 5/2/18. market-based rate authority, with an Power, LLC. Docket Numbers: ER18–1343–000. accompanying rate tariff, noting that Description: Compliance filing: such application includes a request for Informational Filings Regarding Applicants: Carolina Solar Power, LLC. blanket authorization, under 18 CFR Upstream Change in Control to be part 34, of future issuances of securities Description: Baseline eTariff Filing: effective N/A. and assumptions of liability. Application and MBR Tariff to be Filed Date: 4/11/18. Any person desiring to intervene or to effective 6/11/2018. Accession Number: 20180411–5073. protest should file with the Federal Comments Due: 5 p.m. ET 5/2/18. Filed Date: 4/11/18. Energy Regulatory Commission, 888 Docket Numbers: ER15–1136–002. Accession Number: 20180411–5129. First Street NE, Washington, DC 20426, Applicants: Big Cajun I Peaking Comments Due: 5 p.m. ET 5/2/18. in accordance with Rules 211 and 214 Power LLC. Take notice that the Commission of the Commission’s Rules of Practice Description: Compliance filing: received the following PURPA and Procedure (18 CFR 385.211 and Informational Filings Regarding 210(m)(3) filings: 385.214). Anyone filing a motion to Upstream Change in Control to be intervene or protest must serve a copy effective N/A. Docket Numbers: QM18–11–000. of that document on the Applicant. Filed Date: 4/11/18. Applicants: Cloverland Electric Notice is hereby given that the Accession Number: 20180411–5074. Cooperative. deadline for filing protests with regard Comments Due: 5 p.m. ET 5/2/18. Description: Application of to the applicant’s request for blanket Docket Numbers: ER18–1337–000. Cloverland Electric Cooperative To authorization, under 18 CFR part 34, of Applicants: Interstate Power and Terminate Mandatory PURPA Purchase future issuances of securities and Light Company. Obligation. assumptions of liability, is May 1, 2018. Description: § 205(d) Rate Filing: IPL Filed Date: 4/10/18. The Commission encourages & MGE (Saratoga)—LBA Agreement to Accession Number: 20180410–5245. electronic submission of protests and interventions in lieu of paper, using the be effective 6/11/2018. Comments Due: 5 p.m. ET 5/8/18. Filed Date: 4/10/18. FERC Online links at http:// Accession Number: 20180410–5232. The filings are accessible in the www.ferc.gov. To facilitate electronic Comments Due: 5 p.m. ET 5/1/18. Commission’s eLibrary system by service, persons with internet access clicking on the links or querying the who will eFile a document and/or be Docket Numbers: ER18–1338–000. docket number. Applicants: Interstate Power and listed as a contact for an intervenor Light Company. Any person desiring to intervene or must create and validate an Description: § 205(d) Rate Filing: IPL protest in any of the above proceedings eRegistration account using the & Turtle Creek—LBA Agreement to be must file in accordance with Rules 211 eRegistration link. Select the eFiling effective 6/11/2018. and 214 of the Commission’s link to log on and submit the Filed Date: 4/11/18. Regulations (18 CFR 385.211 and intervention or protests. Persons unable to file electronically Accession Number: 20180411–5000. 385.214) on or before 5:00 p.m. Eastern should submit an original and 5 copies Comments Due: 5 p.m. ET 5/2/18. time on the specified comment date. Protests may be considered, but of the intervention or protest to the Docket Numbers: ER18–1339–000. intervention is necessary to become a Federal Energy Regulatory Commission, Applicants: California Independent party to the proceeding. 888 First Street NE, Washington, DC System Operator Corporation. eFiling is encouraged. More detailed 20426. Description: Compliance filing: 2018– information relating to filing The filings in the above-referenced 04–10 Petition for Limited Tariff Waiver requirements, interventions, protests, proceeding are accessible in the & Expedited Consideration Request to service, and qualifying facilities filings Commission’s eLibrary system by be effective N/A. can be found at: http://www.ferc.gov/ clicking on the appropriate link in the Filed Date: 4/11/18. docs-filing/efiling/filing-req.pdf. For above list. They are also available for Accession Number: 20180411–5002. other information, call (866) 208–3676 electronic review in the Commission’s Comments Due: 5 p.m. ET 5/2/18. (toll free). For TTY, call (202) 502–8659. Public Reference Room in Washington, Docket Numbers: ER18–1340–000. DC. There is an eSubscription link on Applicants: South Carolina Electric & Dated: April 11, 2018. the website that enables subscribers to Gas Company. Nathaniel J. Davis, Sr., receive email notification when a Description: Contribution in Aid of Deputy Secretary. document is added to a subscribed Construction Agreement of South [FR Doc. 2018–07997 Filed 4–16–18; 8:45 am] docket(s). For assistance with any FERC Carolina Electric & Gas Company. BILLING CODE 6717–01–P Online service, please email

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[email protected]. or call Commission’s eLibrary system by Advisory Committee Act (FACA), Public (866) 208–3676 (toll free). For TTY, call clicking on the appropriate link in the Law 92–463. The MSTRS provides the (202) 502–8659. above list. They are also available for Clean Air Act Advisory Committee Dated: April 11, 2018. electronic review in the Commission’s (CAAAC) with independent advice, Nathaniel J. Davis, Sr., Public Reference Room in Washington, counsel and recommendations on the Deputy Secretary. DC. There is an eSubscription link on scientific and technical aspects of the website that enables subscribers to programs related to mobile source air [FR Doc. 2018–08000 Filed 4–16–18; 8:45 am] receive email notification when a pollution and its control. BILLING CODE 6717–01–P document is added to a subscribed Through its expert members from docket(s). For assistance with any FERC diverse stakeholder groups and from its DEPARTMENT OF ENERGY Online service, please email various workgroups, the subcommittee [email protected], or call reviews and addresses a wide range of Federal Energy Regulatory (866) 208–3676 (toll free). For TTY, call developments, issues and research areas Commission (202) 502–8659. such as emissions modeling, emission Dated: April 11, 2018. standards and standard setting, air [Docket No. ER18–1310–000] toxics, innovative and incentive-based Nathaniel J. Davis, Sr., transportation policies, onboard Wheelabrator Millbury Inc.; Deputy Secretary. Supplemental Notice That Initial diagnostics, heavy-duty engines, diesel [FR Doc. 2018–07999 Filed 4–16–18; 8:45 am] retrofit, and fuel quality. The Market-Based Rate Filing Includes BILLING CODE 6717–01–P Request for Blanket Section 204 Subcommittee’s website is at: http:// Authorization www.epa.gov/caaac/mobile-sources- technical-review-subcommittee-mstrs- This is a supplemental notice in the ENVIRONMENTAL PROTECTION caaac. above-referenced proceeding of AGENCY Members are appointed by the EPA Wheelabrator Millbury Inc.’s [FRL–9976–83–OAR] Administrator for three-year terms with application for market-based rate the possibility of reappointment to a authority, with an accompanying rate Request for Nominations for Mobile second term. The MSTRS usually meets tariff, noting that such application Sources Technical Review two times annually and the average includes a request for blanket Subcommittee workload for the members is authorization, under 18 CFR part 34, of approximately 5 to 10 hours per month. future issuances of securities and AGENCY: Environmental Protection EPA provides reimbursement for travel assumptions of liability. Agency (EPA). and other incidental expenses Any person desiring to intervene or to ACTION: Request for nominations for associated with official government protest should file with the Federal Mobile Sources Technical Review business for members who qualify. Energy Regulatory Commission, 888 Subcommittee (MSTRS). EPA is seeking nominations from First Street NE, Washington, DC 20426, representatives of nonfederal interests in accordance with Rules 211 and 214 SUMMARY: The U.S. Environmental such as: Protection Agency (EPA) invites of the Commission’s Rules of Practice • Future transportation options and nominations from a diverse range of and Procedure (18 CFR 385.211 and shared mobility interests 385.214). Anyone filing a motion to qualified candidates to be considered • Mobile source emission modeling intervene or protest must serve a copy for appointment to its Mobile Sources interests of that document on the Applicant. Technical Review Subcommittee • Transportation and supply chain Notice is hereby given that the (MSTRS). Vacancies are anticipated to shippers deadline for filing protests with regard be filled by Fall, 2018. Sources in • Marine and inland port interests to the applicant’s request for blanket addition to this Federal Register Notice • Environmental advocacy groups authorization, under 18 CFR part 34, of may also be utilized in the solicitation • Community and/or environmental future issuances of securities and of nominees. justice interests assumptions of liability, is May 1, 2018. DATES: Nominations must be • State and local government interests The Commission encourages postmarked or emailed by May 22, 2018. EPA values and welcomes diversity. electronic submission of protests and ADDRESSES: Submit nominations to: To obtain nominations of diverse interventions in lieu of paper, using the Courtney McCubbin, Designated Federal candidates, EPA encourages FERC Online links at http:// Officer, Office of Transportation and Air nominations of women and men of all www.ferc.gov. To facilitate electronic Quality, U.S Environmental Protection racial and ethnic groups. service, persons with internet access Agency (6401A), 1200 Pennsylvania In selecting members, we will who will eFile a document and/or be Avenue NW, Washington, DC 20460. consider technical expertise, coverage of listed as a contact for an intervenor You may also email nominations with broad stakeholder perspectives, must create and validate an subject line MSTRS2018 to diversity and the needs of the eRegistration account using the [email protected]. subcommittee. eRegistration link. Select the eFiling The following criteria will be used to link to log on and submit the FOR FURTHER INFORMATION CONTACT: evaluate nominees: intervention or protests. Courtney McCubbin, Designated Federal • The background and experiences Persons unable to file electronically Officer, U.S. EPA; telephone: (202) 564– that would help members contribute to should submit an original and 5 copies 2436; email: mccubbin.courtney@ the diversity of perspectives on the of the intervention or protest to the epa.gov. committee (e.g., geographic, economic, Federal Energy Regulatory Commission, SUPPLEMENTARY INFORMATION: social, cultural, educational, and other 888 First Street NE, Washington, DC considerations); 20426. Background • Experience in policy engagement The filings in the above-referenced The MSTRS is a federal advisory across a range of mobility source proceeding are accessible in the committee chartered under the Federal transportation topics;

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• Experience working with future Dated: April 3, 2018. inspection at the EPA, Region 5, transportation options and shared Karl Simon, Records Center, 77 W Jackson Blvd., 7th mobility; Director, Transportation and Climate Fl., Chicago, Illinois 60604. Commenters • Experience working with the Division, Office of Transportation and Air may request an opportunity for a public modeling of mobile source emissions; Quality. hearing in the affected area, in • Experience working with producers [FR Doc. 2018–08018 Filed 4–16–18; 8:45 am] accordance with Section 7003(d) of of passenger cars, engines and trucks, BILLING CODE 6560–50–P RCRA. engine and equipment manufacturing; DATES: Comments must be submitted on • Experience working with fuel or or before 30 days after publication in the renewable fuel producers; ENVIRONMENTAL PROTECTION Federal Register. • Experience working with oil AGENCY ADDRESSES: The proposed settlement is refiners, distributors and retailers of [9976–94—Region 5] mobile source fuels; available for public inspection at the EPA, Region 5, Records Center, 77 W • Experience working with clean Proposed Prospective Purchaser Jackson Blvd., 7th Fl., Chicago, Illinois energy producers; Agreement for the Manual 60604. A copy of the proposed • Experience working with Transmission of Muncie Site in settlement may be obtained from Peter agricultural producers (corn and other Muncie, Indiana crop products), distillers, processors Felitti, Assoc. Regional Counsel, EPA, and shippers of biofuels; AGENCY: Environmental Protection Office of Regional Counsel, Region 5, 77 • Experience working with emission Agency (EPA). W Jackson Blvd., mail code: C–14J, control manufacturers, catalyst and ACTION: Notice; request for public Chicago, Illinois 60604. Comments filter manufacturers; comment. should reference the Manual • Experience working for State and Transmission of Muncie Site, Muncie, local environmental agencies or State SUMMARY: In accordance with the Indiana and should be addressed to Air Pollution Control Agencies; Prospective Purchaser Agreement, Peter Felitti, Assoc. Regional Counsel, • Experience working for notice is hereby given of a proposed EPA, Office of Regional Counsel, Region environmental advocacy groups; administrative settlement concerning 5, 77 W Jackson Blvd., mail code: C–14J, • Experience working for the Manual Transmission of Muncie Chicago, Illinois 60604. environmental and/or community Site in Muncie, Indiana with the FOR FURTHER INFORMATION CONTACT: groups; following Settling Party: Fourteen91 Peter Felitti, Assoc. Regional Counsel, • Experience working with supply Loft, LLC. The settlement requires the EPA, Office of Regional Counsel, Region chain logistics and goods movement; Settling Party to, if necessary, execute 5, 77 W Jackson Blvd., mail code: C–14J, • Experience working with marine and record a Declaration of Restrictive Chicago, Illinois 60604. Covenant; provide access to the Site and port interests; SUPPLEMENTARY INFORMATION: The • exercise due care with respect to Experience in working at the Settling Parties propose to acquire existing contamination. The settlement national level on local governments ownership of the former General Motors includes a covenant not to sue the issues; Corporation North American operation, • Settling Parties pursuant to the Demonstrated experience with at 1220 West 8th Street in Muncie, Comprehensive Environmental environmental and sustainability issues; Indiana. The Site is one of the 89 sites • Response, Compensation, and Liability Executive management level that were placed into an Environmental Act or the Resource Conservation and experience with membership in broad- Response Trust (the ‘‘Trust’’) as a result Recovery Act with respect to the based networks; of the resolution of the 2009 GM • Existing Contamination. Existing Excellent interpersonal, oral and bankruptcy. The Trust is administrated Contamination is defined as any written communication and consensus- by Revitalizing Auto Communities hazardous substances, pollutants, or building skills; Environmental Response. • Ability to volunteer time to attend contaminants or Waste Material present meetings two times a year, participate in or existing on or under the Property as Dated: April 3, 2018. teleconference and webinar meetings, of the Effective Date of the Settlement Douglas E. Ballotti, attend listening sessions with the Agreement; any hazardous substances, Deputy Director, Superfund Division. Administrator or other senior-level pollutants, or contaminants or Waste [FR Doc. 2018–08023 Filed 4–16–18; 8:45 am] officials, develop policy Material that migrated from the Property BILLING CODE 6560–50–P recommendations to the Administrator, prior to the Effective Date; and any and prepare reports and advice letters. hazardous substances, pollutants, or Nominations must include a resume contaminants or Waste Material FEDERAL COMMUNICATIONS and a short biography describing the presently at the Site that migrates onto, COMMISSION professional and educational on, under, or from the Property after the qualifications of the nominee, as well as Effective Date. [OMB 3060–1189] the nominee’s current business address, For thirty (30) days following the date Information Collection Being email address, and daytime telephone of publication of this notice, the Agency Submitted for Review and Approval to number. Interested candidates may self- will receive written comments relating the Office of Management and Budget nominate. to the settlement. The Agency will To help the Agency in evaluating the consider all comments received and AGENCY: Federal Communications effectiveness of its outreach efforts, may modify or withdraw its consent to Commission. please tell us how you learned of this the settlement if comments received ACTION: Notice and request for opportunity. disclose facts or considerations which comments. Please be aware that EPA’s policy is indicate that the settlement is that, unless otherwise prescribed by inappropriate, improper, or inadequate. SUMMARY: As part of its continuing effort statute, members generally are The Agency’s response to any comments to reduce paperwork burdens, and as appointed to three-year terms. received will be available for public required by the Paperwork Reduction

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Act (PRA) of 1995, the Federal under review appears, look for the OMB directs carriers to protect the Communications Commission (FCC or control number of this ICR and then information to the extent it is the Commission) invites the general click on the ICR Reference Number. A considered Customer Proprietary public and other Federal agencies to copy of the FCC submission to OMB Network Information (CPNI). take this opportunity to comment on the will be displayed. Nature and Extent of Confidentiality: following information collection. SUPPLEMENTARY INFORMATION: As part of There is no need for confidentiality with Comments are requested concerning: its continuing effort to reduce this collection of information. Whether the proposed collection of paperwork burdens, and as required by Needs and Uses: The Commission is information is necessary for the proper the Paperwork Reduction Act (PRA) of seeking approval from the Office of performance of the functions of the 1995 (44 U.S.C. 3501–3520), the Federal Management and Budget (OMB) Commission, including whether the Communications Commission (FCC or approval for a three year time period for this information collection requirements information shall have practical utility; the Commission) invites the general approved under this collection. The the accuracy of the Commission’s public and other Federal agencies to following information collection burden estimate; ways to enhance the take this opportunity to comment on the requirements are approved under this quality, utility, and clarity of the following information collection. collection: information collected; ways to minimize Comments are requested concerning: the burden of the collection of Labeling Requirements: Sections Whether the proposed collection of 20.21(a)(5), 20.21(f), 90.219(e)(5)—In information on the respondents, information is necessary for the proper including the use of automated order to avoid consumer confusion and performance of the functions of the provide consumers with needed collection techniques or other forms of Commission, including whether the information technology; and ways to information, the Commission adopted information shall have practical utility; labeling requirements for Consumer and further reduce the information the accuracy of the Commission’s collection burden on small business Industrial Signal Boosters. Consumer burden estimate; ways to enhance the Signal Boosters must be labeled to concerns with fewer than 25 employees. quality, utility, and clarity of the The Commission may not conduct or identify the device as a ‘‘consumer’’ information collected; ways to minimize device and make the consumer aware sponsor a collection of information the burden of the collection of unless it displays a currently valid that the device must be registered; may information on the respondents, only be operated with the consent of the Office of Management and Budget including the use of automated (OMB) control number. No person shall consumer’s wireless provider; may only collection techniques or other forms of be operated with approved antennas be subject to any penalty for failing to information technology; and ways to comply with a collection of information and cables; and that E911 further reduce the information communications may be affected for subject to the PRA that does not display collection burden on small business a valid OMB control number. calls served by using the device. concerns with fewer than 25 employees. Industrial Signal Boosters must include DATES: Written comments should be OMB Control Number: 3060–1189. a label stating that the device is not a submitted on or before May 17, 2018. If Title: Signal Boosters, Sections consumer device, is designed for you anticipate that you will be 1.1307(b)(1), 20.3, 20.21(a)(2), installation by FCC licensees or a submitting comments, but find it 20.21(a)(5), 20.21(e)(2), 20.21(e)(8)(I)(G), qualified installer, and the operator difficult to do so within the period of 20.21(e)(9)(I)(H), 20.21(f), 20.21(h), 22.9, must have a FCC license or consent of time allowed by this notice, you should 24.9, 27.9. 90.203, 90.219(b)(l)(I), a FCC licensee to operate the device. advise the contacts listed below as soon 90.219(d)(5), and 90.219(e)(5). Accordingly, all signal boosters as possible. Form Number: N/A. marketed on or after March 1, 2014, ADDRESSES: Direct all PRA comments to Type of Review: Extension of a must include the advisories (1) in on- Nicholas A. Fraser, OMB, via email currently approved collection. line point-of-sale marketing materials; _ _ Nicholas A. [email protected]; and Respondents: Business or other for- (2) in any print or on-line owner’s to Cathy Williams, FCC, via email PRA@ profit entities, Not for profit institutions manual and installation instructions; (3) fcc.gov and to [email protected]. and Individuals or household. on the outside packaging of the device; Include in the comments the OMB Number of Respondents and and (4) on a label affixed to the device. control number as shown in the Responses: 632,595 respondents and Part 90 signal boosters marketed or sold SUPPLEMENTARY INFORMATION below. 635,215 responses. on or after March 1, 2014, must include FOR FURTHER INFORMATION CONTACT: For Estimated Time per Response: .5 a label stating that the device is not a additional information or copies of the hours-40 hours. consumer device; the operator must information collection, contact Cathy Frequency of Response: have a FCC license or consent of a FCC Williams at (202) 418–2918. To view a Recordkeeping requirement, On licensee to operate the device; the copy of this information collection occasion reporting requirement and operator must register Class B signal request (ICR) submitted to OMB: (1) Go Third party disclosure requirement. boosters; and unauthorized use may to the web page http://www.reginfo.gov/ Obligation to Respond: Required to result in significant forfeitures. public/do/PRAMain, (2) look for the obtain or retain benefits. The statutory Section 20.21(f)(1)(iv)(A)(2)—In order section of the web page called authority for this information collection to ensure that consumers are properly ‘‘Currently Under Review,’’ (3) click on is contained in 47 U.S.C. 154(I), 303(g), informed about which devices are the downward-pointing arrow in the 303(r) and 332. suitable for their use and how to comply ‘‘Select Agency’’ box below the Total Annual Burden: 324,470 hours. with our rules, the Commission required ‘‘Currently Under Review’’ heading, (4) Total Annual Cost: No cost. that all Consumer Signal Boosters select ‘‘Federal Communications Privacy Impact Assessment: This certified for fixed, in-building operation Commission’’ from the list of agencies information collection affects include a label directing consumers that presented in the ‘‘Select Agency’’ box, individuals or households; thus, there the device may only be operated in a (5) click the ‘‘Submit’’ button to the are impacts under the Privacy Act. fixed, in-building location. The Verizon right of the ‘‘Select Agency’’ box, (6) However, the government is not directly Petitioners state that this additional when the list of FCC ICRs currently collecting this information and the R&O labeling requirement is necessary to

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inform purchasers of fixed Consumer are impacts under the Privacy Act. certificated with the consent of the Signal Boosters that they may not However, the government is not directly licensee so the manufacturer must lawfully be installed and operated in a collecting this information and the R&O certify that it has obtained such consent moving vehicle or outdoor location. We directs carriers to protect the as part of the equipment certification recognize that our labeling requirement information to the extent it is process. The R&O also requires that if a imposes additional costs on entities that considered Customer Proprietary manufacturer claims that a device will manufacture Consumer Signal Boosters; Network Information (CPNI). not affect E911 communications, the however, on balance, we find that such Section 20.21(h)—By March 1, 2014, manufacturer must certify this claim costs are outweighed by the benefits of all providers who voluntarily consent to during the equipment certification ensuring that consumers purchase the use of Consumer Signal Boosters on process. Note: The ‘‘application for appropriate devices. Accordingly, all their networks must establish a free equipment’’ certification requirements fixed Consumer Signal Boosters, both registration system for their subscribers. are met under OMB Control Number Provider-Specific and Wideband, At a minimum, providers must collect 3060–0057, FCC Form 731. (1) the name of the Consumer Signal manufactured or imported on or after Antenna Kitting Documentation one year from the effective date of the Booster owner and/or operator, if Requirement: Sections 20.21(e)(8)(i)(G), rule change must include the following different individuals; (2) the make, 20.21(e)(9)(i)(H)—The rules require that advisory (1) in on-line point-of-sale model, and serial number of the device; all consumer boosters must be sold with marketing materials, (2) in any print or (3) the location of the device; and (4) the user manuals specifying all antennas on-line owner’s manual and installation date of initial operation. Otherwise, the and cables that meet the requirements of instructions, (3) on the outside Commission permits providers to this section. Part 90 Licensee Consent packaging of the device, and (4) on a develop their own registration systems Documentation Requirement: Section label affixed to the device: ‘‘This device to facilitate provider control and 90.219(b)(1)(i)—This rule requires that may be operated ONLY in a fixed interference resolution, providers non-licensees seeking to operate part 90 location for in-building use.’’ should collect only such information Section 1.1307(b)(1)—Radiofrequency that is reasonably related to achieving signal boosters must obtain the express (RF). This rule requires that a label is these dual goals. Wireless providers consent of the licensee(s) of the affixed to the transmitting antenna that may determine how to collect such frequencies for which the device or provides adequate notice regarding information and how to keep it up-to- system is intended to amplify. The rules potential RF safety hazards and date. Section 90.219(d)(5)—This rule further require that such consent must references the applicable FCC-adopted requires operators of Part 90 Class B be maintained in a recordable format limits for RF exposure. Provider signal boosters to register these devices that can be presented to a FCC Reporting Requirement: In order to in a searchable on-line database that representative or other relevant licensee facilitate review of wireless providers’ will be maintained and operated by the investigating interference. behavior regarding Consumer Signal Wireless Telecommunications Bureau Cross-reference to Other Rule Parts: Boosters, the R&O requires that on via delegated authority from the Sections 22.9, 24.9, and 27.9— March 1, 2015, and March 1, 2016, all Commission. The Commission believes Operation of a consumer signal booster nationwide wireless providers publicly this will be a valuable tool to resolve under Parts 22, 24, and 27 of the indicate their status regarding consent interference should it occur. Commission’s rules must also comply for each Consumer Signal Booster that Certification Requirements: Sections with section 20.21 of the Commission’s has received FCC certification as listed 20.3, 20.21(e)(2), 20.21(e)(8)(i)(G), rules, including all relevant information in a Public Notice to be released by the 20.21(e)(9)(i)(H), 90.203—These rules, collections. Wireless Telecommunications Bureau in conjunction with the R&O, require Federal Communications Commission. 30 days prior to each reporting date. For that signal booster manufacturers each listed Consumer Signal Booster, demonstrate that they meet the new Katura Jackson, wireless providers should publicly technical specifications using the Federal Register Liaison, Office of the indicate whether they (1) consent to use existing and unchanged equipment Secretary. of the device; (2) do not consent to use authorization application, including [FR Doc. 2018–08027 Filed 4–16–18; 8:45 am] of the device; or (3) are still considering submitting a technical document with BILLING CODE 6712–01–P whether or not they will consent to the the application for FCC equipment use of the device. authorization that shows compliance of Registration Requirements: Section all antennas, cables and/or coupling FEDERAL COMMUNICATIONS 20.21(a)(2)—The rules require signal devices with the requirements of COMMISSION booster operators to register Consumer § 20.21(e). The R&O further provides Signal Boosters, existing and new, with that manufacturers must make certain Open Commission Meeting, Tuesday, their serving wireless providers prior to certifications when applying for device April 17, 2018 operation. This is a mandatory certification. Manufacturers must requirement to continue or begin provide an explanation of all measures April 10, 2018. operation of a Consumer Signal Booster. taken to ensure that the technical The Federal Communications The registration requirement will aid in safeguards designed to inhibit harmful Commission will hold an Open Meeting interference resolution and facilitate interference and protect wireless on the subjects listed below on Tuesday, provider control over Consumer Signal networks cannot be deactivated by the April 17, 2018 which is scheduled to Boosters. The information collection user. The R&O requires that commence at 10:30 a.m. in Room TW– contained in Section 20.21(a)(2) affects manufacturers of Provider-Specific C305, at 445 12th Street SW, individuals or households; thus, there Consumer Signal Boosters may only be Washington, DC.

Item No. Bureau Subject

1 ...... Wireline Competition ...... Title: Protecting Against National Security Threats to the Communications Supply Chain Through FCC Programs (WC Docket No. 18–89).

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Item No. Bureau Subject

Summary: The Commission will consider a Notice of Proposed Rulemaking to ensure that universal service support is not used to purchase equipment or services from companies posing a national security threat to the integrity of communications net- works or the communications supply chain. 2 ...... Wireless Tele-Communications ...... Title: Auctions of Upper Microwave Flexible Use Licenses for Next-Generation Wire- less Services; Competitive Bidding Procedures for Auctions 101 (28 GHz) and 102 (24 GHz) (AU Docket No. 18–85). Summary: The Commission will consider a Public Notice that would seek comment on the procedures for the auctions of Upper Microwave Flexible Use Service li- censes in the 28 GHz and 24 GHz bands. 3 ...... International ...... Title: Streamlining Licensing Procedures for Small Satellites (IB Docket No. 18–86). Summary: The Commission will consider a Notice of Proposed Rulemaking that pro- poses a new, alternative application process designed for a class of satellites re- ferred to as ‘‘small satellites.’’ 4 ...... Wireline Competition ...... Title: Rural Call Completion (WC Docket No. 13–39). Summary: The Commission will consider a Report and Order and Further Notice of Proposed Rulemaking that will adopt new measures, and seek comment on others, to better tackle the problem of call completion and ensure that calls are completed to all Americans—including those in rural America. 5 ...... Wireline Competition ...... Title: Regulation of Business Data Services for Rate-of-Return Local Exchange Car- riers (WC Docket No. 17–144). Summary: The Commission will consider a Notice of Proposed Rulemaking to enable model-based rate-of-return carriers to elect incentive regulation for their lower- speed business data services offerings, and to remove ex ante pricing regulation for packet-based and higher-speed circuit-based offerings. 6 ...... Media ...... Title: Cable Channel Lineup Requirements—Sections 76.1705 and 76.1700(a)(4) (MB Docket No. 18–92); Modernization of Media Regulation Initiative (MB Docket No. 17–105). Summary: The Commission will consider a Notice of Proposed Rulemaking proposing to eliminate the requirement that cable operators maintain a channel lineup at their local office and seeking comment on eliminating the requirement that certain cable operators make their channel lineup available via their online public inspection file. 7 ...... Media ...... Title: Amendment of Section 73.624(g) of the Commission’s Rules Regarding Sub- mission of FCC Form 2100, Schedule G, Used to Report TV Stations’ Ancillary or Supplementary Services (MB Docket No. 17–264); Modernization of Media Regula- tion Initiative (MB Docket No. 17–105). Summary: The Commission will consider a Report and Order that would revise Sec- tion 73.624(g) of its rules to reduce broadcaster reporting obligations relating to the provision of ancillary or supplementary services.

* * * * * Connection also will carry the meeting Communications Commission (FCC or The meeting site is fully accessible to live via the internet. To purchase these Commission) invites the general public people using wheelchairs or other services, call (703) 993–3100 or go to and other Federal agencies to take this mobility aids. Sign language www.capitolconnection.gmu.edu. opportunity to comment on the interpreters, open captioning, and Federal Communications Commission. following information collections. assistive listening devices will be Katura Jackson, Comments are requested concerning: provided on site. Other reasonable Whether the proposed collection of Federal Register Liaison Officer, Office of the accommodations for people with Secretary. information is necessary for the proper disabilities are available upon request. performance of the functions of the [FR Doc. 2018–08028 Filed 4–16–18; 8:45 am] In your request, include a description of Commission, including whether the the accommodation you will need and BILLING CODE 6712–01–P information shall have practical utility; a way we can contact you if we need the accuracy of the Commission’s more information. Last minute requests FEDERAL COMMUNICATIONS burden estimate; ways to enhance the will be accepted, but may be impossible COMMISSION quality, utility, and clarity of the to fill. Send an email to: [email protected] information collected; ways to minimize or call the Consumer & Governmental [OMB 3060–0031] the burden of the collection of Affairs Bureau at 202–418–0530 (voice), information on the respondents, 202–418–0432 (TTY). Information Collection Being Reviewed including the use of automated Additional information concerning by the Federal Communications collection techniques or other forms of this meeting may be obtained from the Commission information technology; and ways to Office of Media Relations, (202) 418– AGENCY: Federal Communications further reduce the information 0500; TTY 1–888–835–5322. Audio/ Commission. collection burden on small business Video coverage of the meeting will be ACTION: Notice and request for concerns with fewer than 25 employees. broadcast live with open captioning comments. The FCC may not conduct or sponsor over the internet from the FCC Live web a collection of information unless it page at www.fcc.gov/live. SUMMARY: As part of its continuing effort displays a currently valid Office of For a fee this meeting can be viewed to reduce paperwork burdens, and as Management and Budget (OMB) control live over George Mason University’s required by the Paperwork Reduction number. No person shall be subject to Capitol Connection. The Capitol Act of 1995 (PRA), the Federal any penalty for failing to comply with

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a collection of information subject to the Commission when an approved recordkeeping requirements associated PRA that does not display a valid OMB assignment of a broadcast station with a joint rule implementing the control number. construction permit or license has been Unlawful internet Gambling DATES: Written PRA comments should consummated. Enforcement Act of 2006 (the ‘‘Act’’). be submitted on or before June 18, 2018. FCC Form 315 and applicable DATES: Comments must be submitted on If you anticipate that you will be exhibits/explanations are required to be or before June 18, 2018. filed when applying for transfer of submitting comments, but find it ADDRESSES: Interested parties are difficult to do so within the period of control of an entity holding an AM, FM, invited to submit written comments to time allowed by this notice, you should LPFM or TV broadcast station either or both of the Agencies. All advise the contact listed below as soon construction permit or license. In comments, which should refer to the as possible. addition, the applicant must notify the Office of Management and Budget Commission when an approved transfer ADDRESSES: Direct all PRA comments to (OMB) control numbers, will be shared Cathy Williams, FCC, via email PRA@ of control of a broadcast station between the Agencies. Direct all written fcc.gov and to [email protected]. construction permit or license has been comments as follows: consummated. Board: You may submit comments, FOR FURTHER INFORMATION CONTACT: For Due to the similarities in the identified by OMB control no. 7100– additional information about the information collected by these two 0317, by any of the following methods: information collection, contact Cathy forms, OMB has assigned both forms • Agency Website: http:// Williams at (202) 418–2918. OMB Control Number 3060–0031. www.federalreserve.gov. Follow the SUPPLEMENTARY INFORMATION: 47 CFR 73.3580 requires local public instructions for submitting comments at Control Number: 3060–0031. notice in a newspaper of general http://www.federalreserve.gov/apps/ Title: Application for Consent to circulation published in the community foia/proposedregs.aspx. Assignment of Broadcast Station in which a station is located of the filing • Email: regs.comments@ Construction Permit or License, FCC of all applications for transfer of control federalreserve.gov. Include OMB Form 314; Application for Consent to or assignment of the license/permit. number in the subject line of the Transfer Control of Entity Holding This notice must be completed within message. Broadcast Station Construction Permit 30 days of the tendering of the • Fax: (202) 452–3819 or (202) 452– or License, FCC Form 315; Section application. This notice must be 3102. 73.3580, Local Public Notice of Filing of published at least twice a week for two • Mail: Ann E. Misback, Secretary, Broadcast Applications. consecutive weeks in a three-week Board of Governors of the Federal Form Number: FCC Forms 314 and period. A copy of this notice and the Reserve System, 20th Street and 315. application must be placed in the Constitution Avenue NW, Washington, Type of Review: Extension of a station’s public inspection file along DC 20551. currently approved collection. with the application, pursuant to All public comments are available Respondents: Business or other for- Section 73.3527. Additionally, an from the Board’s website at http:// profit entities; Not-for-profit applicant for transfer of control of a www.federalreserve.gov/apps/foia/ institutions; State, local or Tribal license must broadcast the same notice proposedregs.aspx as submitted, unless government. over the station at least once daily on modified for technical reasons. Number of Respondents and four days in the second week Accordingly, your comments will not be Responses: 4,840 respondents and immediately following the tendering for edited to remove any identifying or 12,880 responses. filing of the application. Estimated Time per Response: 0.084 contact information. Public comments to 6 hours. Federal Communications Commission. may also be viewed electronically or in Frequency of Response: On occasion Katura Jackson, paper form in Room 3515, 1801 K Street reporting requirement; Third party Federal Register Liaison, Office of the NW (between 18th and 19th Streets disclosure requirement. Secretary. NW), Washington, DC 20006 between Obligation to Respond: Required to [FR Doc. 2018–08026 Filed 4–16–18; 8:45 am] 9:00 a.m. and 5:00 p.m. on weekdays. obtain or retain benefits. Statutory BILLING CODE 6712–01–P For security reasons, the Board requires authority for this collection of that visitors make an appointment to information is contained in Sections inspect comments. You may do so by 154(i), 303(b) and 308 of the BOARD OF GOVERNORS OF THE calling (202) 452–3684. Upon arrival, Communications Act of 1934, as FEDERAL RESERVE SYSTEM visitors will be required to present valid amended. government-issued photo identification Total Annual Burden: 18,670 hours. DEPARTMENT OF THE TREASURY and to submit to security screening in Total Annual Cost: $52,519,656. order to inspect and photocopy Privacy Impact Assessment(s): No Proposed Agency Information comments. impacts. Collection Activities; Comment Treasury: You may submit comments, Nature and Extent of Confidentiality: Request identified by OMB control no. 1505– There is no need for confidentiality and AGENCY: Board of Governors of the 0204, by regular mail to Martha Chacon, respondents are not being asked to Federal Reserve System (‘‘Board’’) and Staff Assistant, U.S. Department of the submit confidential information to the Departmental Offices, Department of the Treasury, 1500 Pennsylvania Avenue Commission. Treasury (‘‘Treasury’’) (collectively, the NW, Room 2000, Washington, DC Needs and Uses: FCC Form 314 and ‘‘Agencies’’). 20220. In addition, comments may be the applicable exhibits/explanations are ACTION: Joint notice, request for sent by fax to (202) 622–1974, or by required to be filed when applying for comment. electronic mail to Martha.Chacon- consent for assignment of an AM, FM, [email protected]. In general, the LPFM or TV broadcast station SUMMARY: The Agencies invite comment Treasury will make all comments construction permit or license. In on a proposal to extend for three years, available in their original format, addition, the applicant must notify the without revision, the mandatory including any business or personal

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information provided such as names, Comments submitted in response to transmitting business operators to addresses, email addresses, or telephone this notice will be shared between the which the Agencies estimate the final numbers, for public inspection and Agencies. All comments received, rule applies. copying in the Treasury library, 1500 including attachments and other Board Pennsylvania Avenue NW, Washington, supporting materials, are part of the DC 20220, on official business days public record and will be included in Estimated number of recordkeepers: between the hours of 10 a.m. and 5 p.m. the submission to the Office of 2,628 depository institutions, 2,839 You can make an appointment to Management and Budget (OMB). credit unions, 7 card system operators, inspect comments by calling (202) 622– Title: Prohibition on Funding of 43 money transmitting business 0990. All comments received, including Unlawful internet Gambling. operators, and 3 new or de novo attachments and other supporting OMB Control Numbers: institutions. materials, are part of the public record Board: 7100–0317. Estimated average annual burden and subject to public disclosure. You Treasury: 1505–0204. hours per recordkeeper: Ongoing annual should only submit comments that you General Description of Report: On burden of 8 hours per recordkeeper for wish to make publicly available. November 18, 2008, the Agencies depository institutions, credit unions, FOR FURTHER INFORMATION CONTACT: A published a joint notice of final card system operators, and money copy of the PRA OMB submission, rulemaking in the Federal Register (73 transmitting business operators. One- including the proposed reporting form FR 69382) adopting a rule on a time burden of 100 hours for new or de and instructions, supporting statement, prohibition on the funding of unlawful novo institutions. and other documentation will be placed internet gambling pursuant to the Act. Estimated frequency: Annually. into OMB’s public docket files, once Identical sets of the final joint rule with Estimated total annual recordkeeping approved. Requests for additional identically numbered sections were burden: Ongoing burden, 44,436 hours information or a copy of the collection adopted by the Board and the Treasury and one-time burden, 300 hours. may be obtained by contacting: within their respective titles of the Code Treasury Board: Federal Reserve Board of Federal Regulations (12 CFR part 233 Estimated number of recordkeepers: Clearance Officer—Nuha Elmaghrabi— for the Board and 31 CFR part 132 for 3,146 depository institutions, 2,839 Office of the Chief Data Officer, Board the Treasury). The compliance date for credit unions, 7 card system operators, of Governors of the Federal Reserve the joint rule was June 1, 2010 (74 FR 43 money transmitting business System, Washington, DC 20551, (202) 62687). The collection of information is operators, and 3 new or de novo 452–3829. Telecommunications Device set out in sections 5 and 6 of the joint institutions. for the Deaf (TDD) users may contact rule.1 Section 5 of the joint rule, as (202) 263–4869, Board of Governors of Estimated average annual burden required by the Act, requires all non- hours per recordkeeper: Ongoing annual the Federal Reserve System, exempt participants in designated Washington, DC 20551. burden of 8 hours per recordkeeper for payment systems to establish and depository institutions, credit unions, Treasury: Steven D. Laughton, implement written policies and Assistant General Counsel (Banking and card system operators, and money procedures reasonably designed to transmitting business operators. One- Finance), (202) 622–8413, U.S. identify and block or otherwise prevent Department of the Treasury, 1500 time burden of 100 hours for new or de or prohibit transactions in connection novo institutions. Pennsylvania Avenue NW, Room 2001, with unlawful internet gambling. Washington, DC 20220. Estimated frequency: Annually. Section 6 of the joint rule provides non- Estimated total annual recordkeeping SUPPLEMENTARY INFORMATION: exclusive examples of policies and burden: Ongoing burden, 48,580 hours Request for Comment on Information procedures deemed by the Agencies to and one-time burden, 300 hours. Collection Proposal be reasonably designed to identify and block or otherwise prevent or prohibit Board of Governors of the Federal Reserve System on March 23, 2018. The Agencies invite public comment transactions restricted by the Act. on the following information collection. Affected Public: Businesses or other Ann E. Misback, Comments are invited on the following: for-profit and not-for-profit Secretary of the Board. a. Whether the proposed collection of organizations. Dated: March 29, 2018. information is necessary for the proper By the Department of the Treasury. performance of the Federal Reserve’s Respondent Burden Spencer W. Clark, functions; including whether the For the purpose of estimating burden Clearance Officer. information has practical utility; and accounting for it with OMB, the b. The accuracy of the Federal [FR Doc. 2018–07945 Filed 4–16–18; 8:45 am] total number of depository institutions Reserve’s estimate of the burden of the BILLING CODE 6210–01–P; 4810–25–P listed for each Agency includes the proposed information collection, number of entities regulated by the including the validity of the Agency and half of the remaining methodology and assumptions used; DEPARTMENT OF HEALTH AND depository institutions and third-party c. Ways to enhance the quality, HUMAN SERVICES processors. Each Agency is also utility, and clarity of the information to accounting for the burden for half of the be collected; Agency for Healthcare Research and d. Ways to minimize the burden of card system operators and money Quality

information collection on respondents, 1 including through the use of automated Section 802 of the Act requires the agencies to Agency Information Collection prescribe joint regulations requiring each Activities: Proposed Collection; collection techniques or other forms of designated payment system, and all participants in information technology; and such systems, to identify and block or otherwise Comment Request e. Estimates of capital or startup costs prevent or prohibit restricted transactions through the establishment of policies and procedures AGENCY: Agency for Healthcare Research and costs of operation, maintenance, reasonably designed to identify and block or and Quality, HHS. and purchase of services to provide otherwise prevent or prohibit the acceptance of ACTION: Notice. information. restricted transactions.

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SUMMARY: This notice announces the The development of the OMR measures to identify items for use in intention of the Agency for Healthcare continues these efforts, and aims to their own registry or research. Meeting Research and Quality (AHRQ) to request achieve the following objectives: the needs of both sets of users is an that the Office of Management and (1) Provide a searchable database of important consideration in the design of Budget (OMB) approve the proposed outcome measures used in patient the OMR. information collection project registries in the United States to Estimated Annual Respondent Burden ‘‘Outcome Measure Repository (OMR).’’ promote collaboration, reduce This proposed information collection redundancy, and improve transparency; Exhibit 1 shows the estimated was previously published in the Federal (2) Facilitate the use of standardized annualized burden hours for the Register on January 29, 2018, and data elements and outcome measures; respondent’s time to contribute to the allowed 60 days for public comment. and OMR. (3) Facilitate the identification of AHRQ received no substantive Based on the number of respondents comments from the public. The purpose potential areas of harmonization. The OMR system will be linked to submitting RoPR records in 2016 (65 of this notice is to allow an additional respondents), it is expected that a 30 days for public comment. RoPR in two key ways. First, users entering registry information in the similar number of stakeholders DATES: Comments on this notice must be RoPR system will be able to associate (approximately 70 respondents) will received by May 17, 2018. OMR measure records with the RoPR provide measure information in the ADDRESSES: Written comments should registry records, and, measure stewards OMR on an annual basis. be submitted to: AHRQ’s OMB Desk listing a measure record in the OMR All users will complete required Officer by fax at (202) 395–6974 system will be able to associate the fields on the ‘‘Measure Profile’’ form. (attention: AHRQ’s desk officer) or by measure with an existing patient _ Some users may also choose to complete email at OIRA submission@ registry in RoPR. Second, users will be the ‘‘Sub-Element Profile’’ form for one omb.eop.gov (attention: AHRQ’s desk able to access both databases with a or more sub-elements associated with a officer). single account (i.e., users with a RoPR given measure although this is not FOR FURTHER INFORMATION CONTACT: account will be able to log in/access the required. The number of sub-elements Doris Lefkowitz, AHRQ Reports OMR using that account, and vice for a given measure is expected to vary Clearance Officer, (301) 427–1477, or by versa). widely. Many users may not provide email at [email protected]. This study is being conducted by sub-element information, while others SUPPLEMENTARY INFORMATION: AHRQ through its contractor, L&M may include five or more. It is expected Policy Research and subcontractors that on average, measure stewards will Proposed Project Truven Health Analytics, an IBM enter information for two sub-elements. Company, and OM1, pursuant to Outcome Measure Repository In September 2017, Truven Health AHRQ’s statutory authority to conduct Analytics consulted with several In accordance with the Paperwork and support research on health care and stakeholders and used a sample of Reduction Act, 44 U.S.C. 3501–3521, on systems for the delivery of such care, existing measure definitions to estimate AHRQ invites public comment on this including activities with respect to the the time required to enter all OMR proposed information collection. In outcomes, cost, cost-effectiveness, and fields. The sample included measures accordance with the agency’s mission, use of health care services and access to representing a range of depth and AHRQ developed the Outcome Measure such services, and with respect to health complexity. For example, one measure Repository (OMR), a web-based database statistics and database development. 42 record contained no sub-element with the purpose of providing a readily U.S.C. 299a(a)(3) and (8). available public resource that includes information, only required fields, and definitions of outcome measures Method of Collection short responses to open text fields (e.g., associated with patient registries. The To achieve the three objectives of this title and description). Another record information being collected in each project, outcome measures and related contained two sub-elements, all OMR record will be visible to the public sub-elements from measure stewards optional fields, and longer responses to and readily available for public use. who populate the OMR database system open text fields. This effort is in alignment the AHRQ will be collected. As a result of the knowledge gained Registry of Patient Registries (RoPR), Users of the OMR will primarily fall during these processes, it is estimated which provides a central point of into two types: Those stewarding a that it will take users 16 minutes, on collection for information about all registry who will provide information average, to enter manually the patient registries in the United States. on the data they collect in their registry, additional fields added through the self- The RoPR furthers AHRQ’s goals to and those who will search for registration process (an average of 12 enhance the description of the quality, information about how a particular type minutes to complete the Measure Profile appropriateness, and effectiveness of of outcome measure is collected within form and 4 minutes to complete two health services, and patient registries in patient registries. For the OMR to Sub-Element Profile sub-forms). If 70 particular, in a more readily available, succeed, the first group of users must be respondents complete the Measure central location by enhancing patient able to enter information into the system Profile form and two Sub-Element registry information, extracted from easily and efficiently. The second group Profile sub-forms, the estimated ClinicalTrials.gov or modeled based on of users must be able to find sufficient annualized burden would be 18.7 hours the ClinicalTrials.gov data elements. information efficiently on outcome total.

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EXHIBIT 1—ESTIMATED ANNUALIZED BURDEN HOURS

Number of Form name Number of responses per Minutes per Total burden respondents respondent response hours

OMR Measure Profile/Sub-Element Profile ...... 70 1 16/60 18.7

Total ...... 70 1 16/60 18.7

Exhibit 2 shows the estimated cost time to participate in the OMR. The estimated at an average of $711.72 burden associated with the respondent’s total cost burden to respondents is annually.

EXHIBIT 2—ESTIMATED ANNUALIZED COST BURDEN

Average Form name Number of Total burden hourly wage Total cost respondents hours rate † burden

OMR Measure Profile/Sub-Element Profile ...... 70 18.7 $38.06 $711.72

Total ...... 70 18.7 38.06 711.72 * Based on the mean wages for Healthcare Practitioners and Technical Occupations, 29–0000. National Compensation Survey: Occupational Wages in the United States May 2016, ‘‘U.S. Department of Labor, Bureau of Labor Statistics.’’ Available at: https://www.bls.gov/oes/current/ oes290000.htm.

Request for Comments DEPARTMENT OF HEALTH AND ADDRESSES: You may submit comments, HUMAN SERVICES identified by Docket No. CDC–2018– In accordance with the Paperwork 0031 by any of the following methods: Reduction Act, comments on AHRQ’s Centers for Disease Control and • Federal eRulemaking Portal: information collection are requested Prevention Regulations.gov. Follow the instructions with regard to any of the following: (a) for submitting comments. Whether the proposed collection of [60Day–18–0792; Docket No. CDC–2018– • Mail: Leroy A. Richardson, information is necessary for the proper 0031] Information Collection Review Office, performance of AHRQ health care Centers for Disease Control and Proposed Data Collection Submitted research and health care information Prevention, 1600 Clifton Road NE, MS– for Public Comment and D74, Atlanta, Georgia 30329. dissemination functions, including Recommendations whether the information will have Instructions: All submissions received practical utility; (b) the accuracy of AGENCY: Centers for Disease Control and must include the agency name and AHRQ’s estimate of burden (including Prevention (CDC), Department of Health Docket Number. CDC will post, without hours and costs) of the proposed and Human Services (HHS). change, all relevant comments to Regulations.gov. collection(s) of information; (c) ways to ACTION: Notice with comment period. enhance the quality, utility and clarity Please note: Submit all comments of the information to be collected; and SUMMARY: The Centers for Disease through the Federal eRulemaking portal (regulations.gov) or by U.S. mail to the (d) ways to minimize the burden of the Control and Prevention (CDC), as part of address listed above. collection of information upon the its continuing effort to reduce public respondents, including the use of burden and maximize the utility of FOR FURTHER INFORMATION CONTACT: To automated collection techniques or government information, invites the request more information on the general public and other Federal other forms of information technology. proposed project or to obtain a copy of agencies the opportunity to comment on the information collection plan and Comments submitted in response to a proposed and/or continuing instruments, contact Leroy A. this notice will be summarized and information collection, as required by Richardson, Information Collection included in the Agency’s subsequent the Paperwork Reduction Act of 1995. Review Office, Centers for Disease request for OMB approval of the This notice invites comment on a Control and Prevention, 1600 Clifton proposed information collection. All proposed information collection project Road NE, MS–D74, Atlanta, Georgia comments will become a matter of titled, Environmental Health Specialists 30329; phone: 404–639–7570; Email: public record. Network (EHS–NET) Program Generic [email protected]. Package. The goal of this food safety SUPPLEMENTARY INFORMATION: Karen Migdail, Under the research program is to collect data in Paperwork Reduction Act of 1995 (PRA) Chief of Staff. retail food establishments that will (44 U.S.C. 3501–3520), Federal agencies [FR Doc. 2018–08009 Filed 4–16–18; 8:45 am] identify and help to understand must obtain approval from the Office of BILLING CODE 4160–90–P environmental factors (e.g., manager Management and Budget (OMB) for each food safety certification, collection of information they conduct implementation of food safety practices, or sponsor. In addition, the PRA also etc.) associated with retail-related requires Federal agencies to provide a foodborne illness and outbreaks. 60-day notice in the Federal Register DATES: CDC must receive written concerning each proposed collection of comments on or before June 18, 2018. information, including each new

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proposed collection, each proposed foodborne illness. In October 2008, determine effective food safety extension of existing collection of OMB approved the EHS-Net program prevention methods. Ultimately, these information, and each reinstatement of generic information collection plan. actions can lead to increased regulatory previously approved information OMB approved renewal collections in program effectiveness and decreased collection before submitting the both 2012 and 2015. To date, EHS-Net foodborne illness. The purpose of the collection to the OMB for approval. To has conducted five individual data information collection is to gather data comply with this requirement, we are collections under this plan. that will help us identify and publishing this notice of a proposed CDC seeks a revision to conduct understand environmental factors data collection as described below. information collections through 2021. associated with foodborne illness. The OMB is particularly interested in The CDC plans to revise the plan in the Specifically, the information will be comments that will help: following ways: used to: (1) The burden hours have increased 1. Evaluate whether the proposed (a) Describe retail food establishment to allow for additional statistical collection of information is necessary food handling and food safety practices designs. The number of restaurants per for the proper performance of the and manager/worker and establishment site (8 EHS-Net sites, which has functions of the agency, including characteristics, whether the information will have remained the same) has increased from (b) Determine how retail food practical utility; 47 to 50 restaurants (totaling 400 2. Evaluate the accuracy of the restaurants); the sample size was establishment and worker agency’s estimate of the burden of the increased to detect a greater odds ratio characteristics are related to food proposed collection of information, and establish a stronger power. handling and food safety practices. including the validity of the (2) The number of respondents has The program Environmental Health methodology and assumptions used; increased to gather additional food Specialists Network (EHS-Net), 3. Enhance the quality, utility, and worker responses per establishment. conducted by a collaborative project of clarity of the information to be Collecting data from additional food CDC, Food and Drug Administration collected; and workers (increased to 10 food workers (FDA), U.S. Department of Agriculture 4. Minimize the burden of the per restaurant from 1 food worker per (USDA), and local and state sites. collection of information on those who restaurant, totaling 4,000 food workers) Environmental factors associated with are to respond, including through the will help minimize the potential bias of foodborne illness include both food use of appropriate automated, only having one worker represent all of safety practices (e.g., inadequate electronic, mechanical, or other food workers in a given establishment. cleaning practices) and the factors in the technological collection techniques or Additionally, going forward the environment associated with those other forms of information technology, restaurant observation data collection by practices (e.g., worker and retail food e.g., permitting electronic submissions the health department (HD) staff will establishment characteristics). To of responses. also be included in the burden table. understand these factors, we need to (3) We expect to conduct up to three 5. Assess information collection costs. continue to collect data from those who studies in a 5-year cooperative period; prepare food (i.e., food workers) and on Proposed Project based on a more accurate study the environments in which the food is schedule in a 5-year EHS-Net Environmental Health Specialists prepared (i.e., retail food establishment cooperative agreement. Therefore, due Network (EHS–NET) Program Generic kitchens). Thus, data collection methods to an increase in the number of Package (OMB Control Number 0920– for this generic information collection restaurants, food workers interviews 0792; expiration date 9/30/2018)— plane include: (1) Screener; (2) manager and addition of restaurant observation Revision—National Center for and food worker interviews/surveys; activity the estimated annual burden Environmental Health (NCEH), Centers and (3) observation of kitchen/ hours expected to increase from 295 to for Disease Control and Prevention restaurant environments. These (CDC). 1,777 annual hours. The goal of this information collection methods allow data collection on food Background and Brief Description is to improve food safety and reduce safety practices and environmental factors associated with those practices. The National Center for foodborne illness, which supports the Environmental Health (NCEH), Centers U.S. Department of Health and Human For each data collection, CDC will for Disease Control and Prevention Services’ Healthy People 2020 Goal. collect data in approximately 50 retail (CDC), is requesting a three-year Office Reducing foodborne illness first requires food establishments per site. Thus, there of Management and Budget approval for identification and understanding of the will be approximately 400 the revision Generic Information environmental factors that cause these establishments per data collection (an Collection plan titled the Environmental illnesses. We need to know how and estimated 8 sites with 50 Health Specialists (EHS-Net). why food becomes contaminated with establishments). The EHS-Net program focuses on foodborne illness pathogens. This The total estimated annual burden for identifying the environmental causes of information can then be used to each data collection will be 1,777 hours.

ESTIMATED ANNUALIZED BURDEN HOURS

Number of Average Number of responses per burden per Total burden Type of respondents Form name respondents response (in hours) respondent (in hours)

Managers ...... EHS-Net Manager Recruiting Script 889 1 3/60 44 Managers ...... EHS-Net Manager Informed Con- 400 1 30/60 200 sent and Interview.

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ESTIMATED ANNUALIZED BURDEN HOURS—Continued

Average Number of Number of burden per Total burden Type of respondents Form name respondents responses per response (in hours) respondent (in hours)

Food Workers ...... EHS-Net Food Worker Recruiting 4,000 1 20/60 1,333 Screener, Informed Consent and Interview. HD staff ...... EHS-Net Restaurant Observation .... 400 1 30/60 200

Total ...... 1,777

Leroy A. Richardson, 1. Electronically. You may submit 489 and those pertaining to activities Chief, Information Collection Review Office, electronic comments on this regulation relating to the survey and certification Office of Scientific Integrity, Office of the to http://www.regulations.gov. Follow of facilities are at 42 CFR part 488. The Associate Director for Science, Office of the the ‘‘Submit a comment’’ instructions. regulations at 42 CFR part 482 specify Director, Centers for Disease Control and 2. By regular mail. You may mail the minimum conditions that a hospital Prevention. written comments to the following must meet to participate in the Medicare [FR Doc. 2018–08007 Filed 4–16–18; 8:45 am] address ONLY: Centers for Medicare & program. BILLING CODE 4163–18–P Medicaid Services, Department of Generally, to enter into an agreement, Health and Human Services, Attention: a hospital must first be certified by a CMS–3357–PN, P.O. Box 8016, state survey agency as complying with DEPARTMENT OF HEALTH AND Baltimore, MD 21244–8010. the conditions or requirements set forth HUMAN SERVICES Please allow sufficient time for mailed in part 482 of our regulations. comments to be received before the Thereafter, the hospital is subject to Centers for Medicare & Medicaid close of the comment period. regular surveys by a state survey agency Services 3. By express or overnight mail. You to determine whether it continues to may send written comments to the meet these requirements. There is an [CMS–3357–PN] following address ONLY: Centers for alternative; however, to surveys by state Medicare & Medicaid Services, agencies. Medicare and Medicaid Program; Department of Health and Human Section 1865(a)(1) of the Act provides Application From DNV GL—Healthcare Services, Attention: CMS–3357–PN, that, if a provider entity demonstrates (DNV GL) for Continued Approval of Its Mail Stop C4–26–05, 7500 Security through accreditation by an approved Hospital Accreditation Program Boulevard, Baltimore, MD 21244–1850. national accrediting organization that all For information on viewing public AGENCY: Centers for Medicare & applicable Medicare conditions are met comments, see the beginning of the Medicaid Services (CMS), HHS. or exceeded, we may deem those SUPPLEMENTARY INFORMATION section. provider entities as having met the ACTION: Notice with request for FOR FURTHER INFORMATION CONTACT: requirements. Accreditation by an comment. Karena Meushaw (410) 786–6609, accrediting organization is voluntary SUMMARY: This proposed notice Patricia Chmielewski, (410) 786–6899 or and is not required for Medicare acknowledges the receipt of an Monda Shaver, (410) 786–3410. participation. application from DNV GL—Healthcare SUPPLEMENTARY INFORMATION: If an accrediting organization is recognized by the Secretary of the for continued recognition as a national Inspection of Public Comments: All Department of Health and Human accrediting organization for hospitals comments received before the close of Services (the Secretary) as having that wish to participate in the Medicare the comment period are available for standards for accreditation that meet or or Medicaid programs. The statute viewing by the public, including any exceed Medicare requirements, any requires that we publish, within 60 days personally identifiable or confidential provider entity accredited by the of receipt of an organization’s complete business information that is included in national accrediting body’s approved application, a notice that identifies the a comment. We post all comments program may be deemed to meet the national accrediting body making the received before the close of the Medicare conditions. A national request, describes the nature of the comment period on the following website as soon as possible after they accrediting organization applying for request, and provides at least a 30-day approval of its accreditation program public comment period. have been received: http:// www.regulations.gov. Follow the search under part 488, subpart A, must provide DATES: To be assured consideration, instructions on that website to view the Centers for Medicare and Medicaid comments must be received at one of public comments. Services (CMS) with reasonable the addresses provided below, no later assurance that the accrediting than 5 p.m. on May 17, 2018. I. Background organization requires the accredited ADDRESSES: In commenting, refer to file Under the Medicare program, eligible provider entities to meet requirements code CMS–3357–PN. Because of staff beneficiaries may receive covered that are at least as stringent as the and resource limitations, we cannot services from a hospital, provided that Medicare conditions. Our regulations accept comments by facsimile (FAX) certain requirements are met. Section concerning the approval of accrediting transmission. 1861(e) of the Social Security Act (the organizations are set forth at § 488.5. Comments, including mass comment Act), establishes distinct criteria for The regulations at § 488.5(e)(2)(i) submissions, must be submitted in one facilities seeking designation as a require accrediting organizations to of the following three ways (please hospital. Regulations concerning reapply for continued approval of its choose only one of the ways listed): provider agreements are at 42 CFR part accreditation program every 6 years or

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sooner as determined by CMS. DNV ability of the organization to provide able to acknowledge or respond to them GL—Healthcare (DNV GL) current term continuing surveyor training. individually. We will consider all of approval for their hospital ++ The comparability of DNV GL’s comments we receive by the date and accreditation program expires processes to those of state agencies, time specified in the DATES section of September 26, 2018. including survey frequency, and the this preamble, and, when we proceed ability to investigate and respond with a subsequent document, we will II. Provisions of the Proposed Notice appropriately to complaints against respond to the comments in the A. Approval of Deeming Organizations accredited facilities. preamble to that document. ++ DNV GL’s processes and Section 1865(a)(2) of the Act and our Dated: April 9, 2018. procedures for monitoring a hospital regulations at § 488.5 require that our Seema Verma, found out of compliance with the DNV findings concerning review and GL’s program requirements. These Administrator, Centers for Medicare & approval of a national accrediting Medicaid Services. monitoring procedures are used only organization’s requirements consider, when the DNV GL identifies [FR Doc. 2018–07982 Filed 4–16–18; 8:45 am] among other factors, the applying noncompliance. If noncompliance is BILLING CODE 4120–01–P accrediting organization’s requirements identified through validation reviews or for accreditation; survey procedures; complaint surveys, the state survey resources for conducting required DEPARTMENT OF HEALTH AND agency monitors corrections as specified surveys; capacity to furnish information HUMAN SERVICES at § 488.9(c). for use in enforcement activities; ++ DNV GL’s capacity to report monitoring procedures for provider Food and Drug Administration deficiencies to the surveyed facilities entities found not in compliance with and respond to the facility’s plan of the conditions or requirements; and correction in a timely manner. [Docket No. FDA–2014–N–2294] ability to provide us with the necessary ++ DNV GL’s capacity to provide CMS Agency Information Collection data for validation. with electronic data and reports Section 1865(a)(3)(A) of the Act Activities; Submission for Office of necessary for effective validation and Management and Budget Review; further requires that we publish, within assessment of the organization’s survey 60 days of receipt of an organization’s Comment Request; Evaluation of the process. Fresh Empire Campaign on Tobacco complete application, a notice ++ The adequacy of DNV GL’s staff identifying the national accrediting and other resources, and its financial AGENCY: Food and Drug Administration, body making the request, describing the viability. HHS. nature of the request, and providing at ++ DNV GL’s capacity to adequately ACTION: Notice. least a 30-day public comment period. fund required surveys. We have 210 days from the receipt of a ++ DNV GL’s policies with respect to SUMMARY: The Food and Drug complete application to publish notice whether surveys are announced or Administration (FDA) is announcing of approval or denial of the application. unannounced, to assure that surveys are that a proposed collection of The purpose of this proposed notice unannounced. information has been submitted to the is to inform the public of DNV GL’s ++ DNV GL’s agreement to provide Office of Management and Budget request for continued approval of its CMS with a copy of the most current (OMB) for review and clearance under hospital accreditation program. This accreditation survey together with any the Paperwork Reduction Act of 1995 notice also solicits public comment on other information related to the survey (the PRA). whether DNV GL’s requirements meet or as we may require (including corrective DATES: Fax written comments on the exceed the Medicare conditions of action plans). participation (CoPs) for hospitals. collection of information by May 17, C. Notice Upon Completion of 2018. B. Evaluation of Deeming Authority Evaluation ADDRESSES: Request To ensure that comments on Upon completion of our evaluation, the information collection are received, DNV GL submitted all the necessary including evaluation of public OMB recommends that written materials to enable us to make a comments received as a result of this comments be faxed to the Office of determination concerning its request for notice, we will publish a final notice in Information and Regulatory Affairs, continued approval of its hospital the Federal Register announcing the OMB, Attn: FDA Desk Officer, Fax: 202– accreditation program. This application result of our evaluation. 395–7285, or emailed to oira_ was determined to be complete on [email protected]. All February 28, 2018. Under section III. Collection of Information comments should be identified with the 1865(a)(2) of the Act and our regulations Requirements OMB control number 0910–0788. Also at § 488.5 (Application and re- This document does not impose include the FDA docket number found application procedures for national information collection requirements, in brackets in the heading of this accrediting organizations), our review that is, reporting, recordkeeping or document. and evaluation of DNV GL will be third-party disclosure requirements. FOR FURTHER INFORMATION CONTACT: conducted in accordance with, but not Consequently, there is no need for Amber Sanford, Office of Operations, necessarily limited to, the following review by the Office of Management and Food and Drug Administration, Three factors: Budget under the authority of the White Flint North, 10A–12M, 11601 • The equivalency of DNV GL’s Paperwork Reduction Act of 1995 (44 Landsdown St., North Bethesda, MD standards for hospitals as compared U.S.C. Chapter 35). with CMS’ hospital CoPs. 20852, 301–796–8867, PRAStaff@ • DNV GL’s survey process to IV. Response to Comments fda.hhs.gov. determine the following: Because of the large number of public SUPPLEMENTARY INFORMATION: In ++ The composition of the survey comments we normally receive on compliance with 44 U.S.C. 3507, FDA team, surveyor qualifications, and the Federal Register documents, we are not has submitted the following proposed

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collection of information to OMB for are conducted among youth who A total of 2,100 youth will voluntarily review and clearance. participated in one or more surveys (the complete questionnaires for the fourth embedded longitudinal cohort) and new post-test survey, and the same number Evaluation of the Food and Drug participants who are recruited to make will complete questionnaires for the Administration’s ‘Fresh Empire’ up for attrition. Eligible youth were fifth post-test survey. These respondents Multicultural Youth Tobacco initially 12 to 17 years old and will include existing youth who have Prevention Campaign influenced by the hip-hop peer crowd. participated in one or more surveys OMB Control Number 0910–0788— Youth in the embedded longitudinal previously (‘‘Longitudinal Cohort’’) and Extension cohort may reach the age of 18 over the new youth recruited via a mail-based The 2009 Family Smoking Prevention course of the evaluation. screener or social media ads (‘‘Cross- To date, the pre-test and three post- Sectional Refresher Sample’’). Based on and Tobacco Control Act (Tobacco test surveys have been conducted. earlier response rates and longitudinal Control Act) (Pub. L. 111–31) amended Information has been collected about respondents aging out of the eligibility the Federal Food, Drug, and Cosmetic youth awareness of and exposure to criteria (over the age of 18), we expect Act (FD&C Act) to grant FDA authority campaign events and advertisements to need to recruit a larger number of to regulate the manufacture, marketing, and about tobacco-related knowledge, cross-sectional respondents than in and distribution of tobacco products to attitudes, beliefs, intentions, and use. previous waves. We estimate that protect public health and to reduce Information has also been collected on approximately 600 longitudinal youth tobacco use by minors. Section demographic variables including age, and 1,500 cross-sectional youth will 1003(d)(2)(D) of the FD&C Act (21 sex, race/ethnicity, grade level, and voluntarily participate in each of the U.S.C. 393(d)(2)(D)) supports the primary language. fourth and fifth post-test surveys. With development and implementation of All information is voluntarily an estimated burden of 45 minutes per FDA public education campaigns provided and is being collected through respondent, this adds 450 hours for related to tobacco use. Accordingly, in-person and web-based longitudinal respondents and 1,125 FDA is currently developing and questionnaires. Youth respondents were hours for cross-sectional respondents for implementing a youth-targeted public recruited from two sources: (1) A each of the fourth and fifth post-test education campaign (‘Fresh Empire’) to sample drawn from 30 U.S. media evaluation surveys. help prevent tobacco use among markets gathered using an address- A mail-based screener was one of the multicultural youth and thereby reduce based postal mail sampling of U.S. methods used to identify eligible youth the public health burden of tobacco. The households for the outcome evaluation, for the pre-test survey. This method will campaign features events, and (2) targeted social media (e.g., be used during the fourth post-test advertisements on television and radio Facebook, Instagram). survey to recruit new youth aged 12 to and in print, digital communications This study is being conducted in 17 to ensure that the sample including social media, and other forms support of the provisions of the Tobacco composition is similar across rounds of of media. Control Act that require FDA to protect data collection. As was done during the Evaluation is an essential the public health and to educate the pre-test survey, parents or guardians organizational practice in public health population about the risks and potential will be asked to provide consent and and a systematic way to account for and risks of tobacco use. The information their contact information on this form. improve public health actions. being collected is necessary to inform For the fourth post-test survey, the 5- Comprehensive evaluation of FDA’s FDA’s efforts towards these goals and to minute youth screener and the 1-minute multicultural public education measure the effectiveness and public parental consent will be completed by campaign will be used to document health impact of the campaign. Data 9,869 households for a total of 822 whether the intended audience is aware from the outcome evaluation are being burden hours for youth and an of and understands campaign messages, used to estimate awareness of and additional 164 hours for the parents or and whether campaign exposure exposure to the campaign among youth guardians. This method will not be used influences specific cognitive outcomes in target markets where the campaign is during the fifth post-test survey, for related to tobacco use that are targeted active. Data are also being used to which new participants will be by the campaign. examine statistical associations between recruited only via social media. FDA is in the process of evaluating exposure to the campaign and We will continue to recruit new youth the effectiveness of its multicultural subsequent changes in specific through social media (e.g., Facebook, youth tobacco prevention campaign outcomes of interest, which include Instagram) as a secondary strategy to through an outcome evaluation study knowledge, attitudes, and beliefs related recruit youth aged 13 to 17. An online that follows the multiple, discrete waves to tobacco use. version of the screener described above of media advertising planned for the FDA requests OMB approval to will continue to be used to identify campaign. All information collected is extend OMB approval of the evaluation eligible youth. The screener will take 5 integral to that evaluation. of FDA’s multicultural youth tobacco minutes to complete and will be taken FDA’s Fresh Empire youth tobacco public education campaign and to add by an additional 4,000 youth during public education campaign aims to two additional waves of data collection each of the fourth and fifth post-test reduce tobacco use among youth who with existing youth in the study. To surveys, for a total of 8,000 additional affiliate with a hip-hop peer crowd, accommodate these two additional youth respondents and 666 total predominantly among African surveys, FDA requests approval to additional burden hours. The new total American, Hispanic, and Asian/Pacific increase the number of burden hours number of voluntary participants for the Islander youth. The outcome evaluation under the existing control number. The youth online post-test screener will be of the campaign consists of a pre-test fourth post-test survey will begin in July 32,000 and the total burden will be survey of youth aged 12 to 17 before 2018. The fifth post-test survey will 2,666 hours. This includes the originally campaign launch followed by a series of begin in February 2019. As was done in approved 24,000 participants and 2,000 post-test surveys beginning earlier post-test surveys, new youth will burden hours. approximately 6 months after the be recruited to participate to make up As was done previously, eligible campaign launch. The post-test surveys for attrition. youth aged 13 to 14 who complete the

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online screener will be asked to provide hours. Added to the original 6,000 hours—an estimated increase of 4,813 their parents’ or guardians’ contact parents and 100 burden hours, the total hours from the last approval. information to provide parental consent number of parental online screeners and In the Federal Register of December for the main survey. The process of consents will be 6,700 and the total 26, 2017 (82 FR 61003), FDA published parents and guardians providing burden will be 111 hours. a 60-day notice requesting public consent for eligible youth will take comment on the proposed collection of With these additions, the estimated approximately 1 minute. For the fourth information. One comment was number of voluntary respondents/ and fifth post-test surveys, we estimate received; however, this comment was that an additional 700 adults will be responses for all waves of data not PRA related. contacted to provide consent for eligible collection for the study is 107,743, and FDA estimates the burden of this youth for a total of 11 additional burden the total burden is estimated at 15,135 collection of information as follows:

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

Number of Type of respondent/activity Number of responses per Total annual Average burden per Total hours respondents respondent responses response

Youth Mail screener-outcome survey ...... 23,685 1 23,685 0.0833 (5 minutes) .... 1,973 Cross-Sectional Youth Refresher Sample, Post-test 4,920 1 4,920 0.75 (45 minutes) ...... 3,690 and assent/consent process-outcome surveys 1– 5. Youth Pre-test and assent/consent process-out- 2,194 1 2,194 0.50 (30 minutes) ...... 1,097 come survey. Longitudinal Youth Cohort, Post-test and assent/ 6,039 1 6,039 0.75 (45 minutes) ...... 4,530 consent process-outcome surveys 1–5. Youth Online screener-outcome survey ...... 40,000 1 40,000 0.0833 (5 minutes) .... 3,332 Adult parental permission process-outcome survey 30,905 1 30,905 0.0166 (1 minute) ...... 513

Total ...... 107,743 ...... 15,135 1 There are no capital costs or operating and maintenance costs associated with this collection of information.

Dated: April 12, 2018. Information and Regulatory Affairs, of any person for information respecting Leslie Kux, OMB, Attn: FDA Desk Officer, Fax: 202– the class in which a device has been Associate Commissioner for Policy. 395–7285, or emailed to oira_ classified or the requirements applicable [FR Doc. 2018–07971 Filed 4–16–18; 8:45 am] [email protected]. All to a device under the FD&C Act, the BILLING CODE 4164–01–P comments should be identified with the Secretary of Health and Human Services OMB control number 0910–0705. Also shall provide such person a written include the FDA docket number found statement of the classification (if any) of DEPARTMENT OF HEALTH AND in brackets in the heading of this such device and the requirements of the HUMAN SERVICES document. FD&C Act applicable to the device. FOR FURTHER INFORMATION CONTACT: Regulations governing medical device Food and Drug Administration Amber Sanford, Office of Operations, classification procedures are codified [Docket No. FDA–2014–N–0913] Food and Drug Administration, Three under 21 CFR part 860. White Flint North, 10A–12M, 11601 The guidance document entitled Agency Information Collection Landsdown St., North Bethesda, MD ‘‘FDA and Industry Procedures for Activities; Submission for Office of 20852, 301–796–8867, PRAStaff@ Section 513(g) Requests for Information Management and Budget Review; fda.hhs.gov. Under the Federal Food, Drug, and Comment Request; 513(g) Request for Cosmetic Act; Guidance for Industry Information SUPPLEMENTARY INFORMATION: In and Food and Drug Administration compliance with 44 U.S.C. 3507, FDA Staff’’ establishes procedures for AGENCY: Food and Drug Administration, has submitted the following proposed submitting, reviewing, and responding HHS. collection of information to OMB for to requests for information respecting ACTION: Notice. review and clearance. the class in which a device has been classified or the requirements applicable SUMMARY: The Food and Drug 513(g) Request for Information to a device under the FD&C Act that are Administration (FDA) is announcing OMB Control Number 0910–0705— submitted in accordance with section that a proposed collection of Extension 513(g) of the FD&C Act. FDA does not information has been submitted to the This information collection supports review data related to substantial Office of Management and Budget Agency regulations and accompanying equivalence or safety and effectiveness (OMB) for review and clearance under guidance. Section 513(g) of the Federal in a 513(g) request for information. the Paperwork Reduction Act of 1995. Food, Drug, and Cosmetic Act (the FDA’s responses to 513(g) requests for DATES: Fax written comments on the FD&C Act) (21 U.S.C. 360c(g)) provides information are not device classification collection of information by May 17, a means for obtaining the Agency’s decisions and do not constitute FDA 2018. views about the classification and clearance or approval for marketing. ADDRESSES: To ensure that comments on regulatory requirements that may be Classification decisions and clearance or the information collection are received, applicable to a particular device. approval for marketing require OMB recommends that written Section 513(g) provides that, within 60 submissions under different sections of comments be faxed to the Office of days of the receipt of a written request the FD&C Act.

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Relatedly, the FD&C Act, as amended FDA staff and regulated industry by a 60-day notice requesting public by the Food and Drug Administration describing the user fees associated with comment on the proposed collection of Amendments Act of 2007 (Pub. L. 110– 513(g) requests. The Medical Device information. No comments were 85), requires FDA to collect user fees for User Fee Cover Sheet (Form FDA 3601), received in response to the notice. which accompanies the supplemental 513(g) requests for information. The We therefore retain the currently material described in this information guidance document entitled ‘‘Guidance approved burden estimate for the collection is approved under OMB for Industry and Food and Drug information collection, which is as Administration Staff; User Fees for control number 0910–0511. In the Federal Register of November follows: 513(g) Requests for Information’’ assists 21, 2017 (82 FR 55381) FDA published

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

Number of Average Activity Number of responses per Total annual burden per Total hours respondents respondent responses response

CDRH 513(g) requests ...... 114 1 114 12 1,368 CBER 513(g) requests ...... 4 1 4 12 48

Total ...... 1,416 1 There are no capital costs of operating and maintenance costs associated with this collection off information.

Respondents to the collection of ADDRESSES: You may submit either • For written/paper comments information are mostly device electronic or written comments on submitted to the Dockets Management manufacturers; however, anyone may Agency guidances at any time as Staff, FDA will post your comment, as submit a 513(g) request for information. follows: well as any attachments, except for The total number of annual responses is information submitted, marked and Electronic Submissions based on the average number of 513(g) identified, as confidential, if submitted requests received each year by the Submit electronic comments in the as detailed in ‘‘Instructions.’’ Agency. following way: Instructions: All submissions received must include the Docket No. FDA– Dated: April 12, 2018. • Federal eRulemaking Portal: https://www.regulations.gov. Follow the 2009–D–0524 for ‘‘Listing of Ingredients Leslie Kux, in Tobacco Products.’’ Received Associate Commissioner for Policy. instructions for submitting comments. Comments submitted electronically, comments will be placed in the docket [FR Doc. 2018–07980 Filed 4–16–18; 8:45 am] including attachments, to https:// and, except for those submitted as BILLING CODE 4164–01–P www.regulations.gov will be posted to ‘‘Confidential Submissions,’’ publicly the docket unchanged. Because your viewable at https://www.regulations.gov comment will be made public, you are or at the Dockets Management Staff DEPARTMENT OF HEALTH AND between 9 a.m. and 4 p.m., Monday HUMAN SERVICES solely responsible for ensuring that your comment does not include any through Friday. • Confidential Submissions—To confidential information that you or a Food and Drug Administration submit a comment with confidential third party may not wish to be posted, information that you do not wish to be such as medical information, your or [Docket No. FDA–2009–D–0524] made publicly available, submit your anyone else’s Social Security number, or comments only as a written/paper confidential business information, such Listing of Ingredients in Tobacco submission. You should submit two Products; Guidance for Industry; as a manufacturing process. Please note copies total. One copy will include the Availability that if you include your name, contact information you claim to be confidential information, or other information that with a heading or cover note that states AGENCY: Food and Drug Administration, identifies you in the body of your HHS. ‘‘THIS DOCUMENT CONTAINS comments, that information will be CONFIDENTIAL INFORMATION.’’ The ACTION: Notice of availability. posted on https://www.regulations.gov. Agency will review this copy, including • If you want to submit a comment the claimed confidential information, in SUMMARY: The Food and Drug with confidential information that you its consideration of comments. The Administration (FDA or we) is do not wish to be made available to the second copy, which will have the announcing the availability of a revised public, submit the comment as a claimed confidential information final guidance for industry entitled written/paper submission and in the redacted/blacked out, will be available ‘‘Listing of Ingredients in Tobacco manner detailed (see ‘‘Written/Paper for public viewing and posted on Products.’’ The revised guidance Submissions’’ and ‘‘Instructions’’). https://www.regulations.gov. Submit document is intended to assist persons both copies to the Dockets Management making tobacco product ingredient Written/Paper Submissions Staff. If you do not wish your name and submissions to FDA as required by the Submit written/paper submissions as contact information to be made publicly Family Smoking Prevention and follows: available, you can provide this Tobacco Control Act (Tobacco Control • Mail/Hand delivery/Courier (for information on the cover sheet and not Act). written/paper submissions): Dockets in the body of your comments and you DATES: The announcement of the Management Staff (HFA–305), Food and must identify this information as guidance is published in the Federal Drug Administration, 5630 Fishers ‘‘confidential.’’ Any information marked Register on April 17, 2018. Lane, Rm. 1061, Rockville, MD 20852. as ‘‘confidential’’ will not be disclosed

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except in accordance with 21 CFR 10.20 clarifies ways in which tobacco product Dated: April 11, 2018. and other applicable disclosure law. For manufacturers and importers can submit Leslie Kux, more information about FDA’s posting ingredient listing submissions as Associate Commissioner for Policy. of comments to public dockets, see 80 required by section 904(a)(1) of the [FR Doc. 2018–07973 Filed 4–16–18; 8:45 am] FR 56469, September 18, 2015, or access Federal Food, Drug, and Cosmetic Act BILLING CODE 4164–01–P the information at: https://www.gpo.gov/ (FD&C Act) (21 U.S.C. 387d(a)(1)). fdsys/pkg/FR-2015-09-18/pdf/2015- Although this guidance document is 23389.pdf. immediately effective, it remains subject DEPARTMENT OF HEALTH AND Docket: For access to the docket to to comment in accordance with FDA’s HUMAN SERVICES read background documents or the GGP regulation. electronic and written/paper comments Food and Drug Administration The Tobacco Control Act, enacted on received, go to https:// [Docket No. FDA–2018–N–0001] www.regulations.gov and insert the June 22, 2009, amends the FD&C Act docket number, found in brackets in the and provides FDA with the authority to Advisory Committees; Filing of Closed heading of this document, into the regulate the manufacture, marketing, Meeting Reports ‘‘Search’’ box and follow the prompts and distribution of tobacco products to and/or go to the Dockets Management protect the public health (Pub. L. 111– AGENCY: Food and Drug Administration, Staff, 5630 Fishers Lane, Rm. 1061, 31, 123 Stat. 1776). Among its many HHS. Rockville, MD 20852. provisions, the Tobacco Control Act ACTION: Notice. You may submit comments on any added section 904 to the FD&C Act, SUMMARY: The Food and Drug guidance at any time (see 21 CFR establishing requirements for tobacco Administration (FDA) is announcing 10.115(g)(5)). product ingredient submissions. Submit written requests for single that, as required by the Federal copies of the revised draft guidance to II. Significance of Guidance Advisory Committee Act, the Agency the Center for Tobacco Products, Food has filed with the Library of Congress This revised guidance is being issued and Drug Administration, Document the annual reports of those FDA Control Center, 10903 New Hampshire consistent with FDA’s good guidance advisory committees that held closed Ave., Bldg. 71, Rm. G335, Silver Spring, practices regulation (21 CFR 10.115). meetings during fiscal year 2017. MD 20993–0002. Send two self- The guidance represents the current ADDRESSES: Copies are available at the addressed adhesive labels to assist that thinking of FDA on listing of ingredients Dockets Management Staff (HFA–305), office in processing your requests. See in tobacco products. It does not Food and Drug Administration, 5630 the SUPPLEMENTARY INFORMATION section establish any rights for any person and Fishers Lane, Rm. 1061, Rockville, MD for electronic access to the guidance is not binding on FDA or the public. 20852, 240–402–7500. You also may document. You can use an alternative approach if access the docket at https:// it satisfies the requirements of the www.regulations.gov for the annual FOR FURTHER INFORMATION CONTACT: reports of those FDA advisory Katherine Collins or Deirdre Jurand, applicable statutes and regulations. This committees that held closed meetings Center for Tobacco Products, Food and guidance is not subject to Executive during fiscal year 2017. Insert the Drug Administration, Document Control Order 12866. docket number found in brackets in the Center, 10903 New Hampshire Ave., III. Paperwork Reduction Act of 1995 heading of this document at https:// Bldg. 71, Rm. G335, Silver Spring, MD www.regulations.gov into the ‘‘Search’’ 20993–0002, 1–877–287–1373, email: This revised guidance refers to box, clear filter under Document Type [email protected]. previously approved collections of (left side of screen), and check information found in FDA regulations. SUPPLEMENTARY INFORMATION: ‘‘Supporting and Related Material,’’ The revised draft guidance includes I. Background then Sort By Best Match (from the drop- information and recommendations for down menu; top right side of screen), We are announcing the availability of how to provide ingredient listing ‘‘ID Number (Z–A)’’ or Sort By Best a revised guidance for industry entitled submissions for tobacco products. These Match (from the drop-down menu) ‘‘Listing of Ingredients in Tobacco collections of information are subject to ‘‘Title (A–Z),’’ also found in the heading Products.’’ The revised guidance review by the Office of Management and of this document. document is intended to assist persons Budget (OMB) under the Paperwork FOR FURTHER INFORMATION CONTACT: making tobacco product ingredient Reduction Act of 1995 (44 U.S.C. 3501– submissions to FDA as required by the Russell Fortney, Director, Advisory 3520). The collections of information in Committee Oversight and Management Tobacco Control Act. section 904(a)(1) of the FD&C Act have We are issuing this guidance Staff, Food and Drug Administration, been approved under OMB control consistent with our good guidance 10903 New Hampshire Ave., Silver number 0910–0650. practices (GGP) regulation (§ 10.115 (21 Spring, MD 20993–0002, 301–796–1068. CFR 10.115)). We are implementing this IV. Electronic Access SUPPLEMENTARY INFORMATION: Under guidance without prior public comment section 10(d) of the Federal Advisory because we have determined that prior Persons with access to the internet Committee Act (5 U.S.C. app.) and 21 public participation is not feasible or may obtain an electronic version of the CFR 14.60(d), FDA has filed with the appropriate given the requirement that revised guidance at either https:// Library of Congress the annual reports ingredient listing submissions be www.regulations.gov or https:// for the following FDA advisory submitted by May 8, 2018 www.fda.gov/TobaccoProducts/ committees that held closed meetings (§ 10.115(g)(2)). We made this Labeling/RulesRegulationsGuidance/ during the period October 1, 2016, determination because FDA needs to default.htm. Use the FDA website listed through September 30, 2017: timely communicate that the guidance in the previous sentence to find the Center for Biologics Evaluation and presents a less burdensome policy that most current version of the guidance. Research: is consistent with the public health and Allergenic Products Advisory

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Committee FDA’s performance commitment under as a manufacturing process. Please note Blood Products Advisory Committee PDUFA VI. For this pilot program, that if you include your name, contact National Center for Toxicological MIDD is defined as the application of information, or other information that Research: exposure-based, biological, and/or identifies you in the body of your Science Board to the National Center statistical models derived from comments, that information will be for Toxicological Research preclinical and clinical data sources to posted on https://www.regulations.gov. Center for Drug Evaluation and address drug development and/or • If you want to submit a comment Research: regulatory issues (see Supplementary with confidential information that you Joint Meetings of the Anesthetic and Information, I. Background, and II. do not wish to be made available to the Analgesic Drug Products Advisory Eligibility and Selection for public, submit the comment as a Committee and the Drug Safety and Participation of this notice). For each written/paper submission and in the Risk Management Advisory approved proposal, the pilot program manner detailed (see ‘‘Written/Paper Committee consists of two meetings between Submissions’’ and ‘‘Instructions’’). Drug Safety and Risk Management sponsors or applicants and the relevant Written/Paper Submissions Advisory Committee center and will provide an opportunity Submit written/paper submissions as Annual Reports are available for public for drug developers and FDA to discuss the application of MIDD approaches to follows: inspections between 9 a.m. and 4 p.m., • Mail/Hand delivery/Courier (for the development and regulatory Monday through Friday, at: written/paper submissions): Dockets evaluation of medical products in (1) The Library of Congress, Madison Management Staff (HFA–305), Food and development. Building, Newspaper and Current Drug Administration, 5630 Fishers Periodical Reading Room, 101 DATES: FDA will accept requests to Lane, Rm. 1061, Rockville, MD 20852. Independence Ave. SE, Rm. 133, participate in the program on a • For written/paper comments Washington, DC 20540; and continuous basis beginning on April 17, submitted to the Dockets Management (2) Dockets Management Staff (HFA– 2018 through June 15, 2022. See section Staff, FDA will post your comment, as 305), Food and Drug Administration, III of this notice for instructions about well as any attachments, except for 5630 Fishers Lane, Rm. 1061, Rockville, how to request participation in the pilot information submitted, marked and MD 20852. program. Meeting-granted and -denied identified, as confidential, if submitted Dated: April 12, 2018. decisions will be made the last 2 weeks as detailed in ‘‘Instructions.’’ Leslie Kux, of each quarter of the fiscal year based Instructions: All submissions received Associate Commissioner for Policy. on submissions received to date. must include the Docket No. FDA– 2018–N–1203 for ‘‘Pilot Meetings [FR Doc. 2018–07981 Filed 4–16–18; 8:45 am] Requesters will receive a meeting- granted or -denied notification the first Program for Model-Informed Drug BILLING CODE 4164–01–P week of the new quarter. Development Approaches.’’ Received The pilot program meetings will begin comments will be placed in the docket DEPARTMENT OF HEALTH AND in Q4 of FY 2018 (July 1–September 30, and, except for those submitted as HUMAN SERVICES 2018), and run through Q4 of FY 2022 ‘‘Confidential Submissions,’’ publicly (September 30, 2022). Proposals not viewable at https://www.regulations.gov Food and Drug Administration selected for a given quarter will be so or at the Dockets Management Staff notified by the Agency. Sponsors who between 9 a.m. and 4 p.m., Monday [Docket No. FDA–2018–N–1203] are not chosen to participate in the pilot through Friday. • Pilot Meetings Program for Model- program may seek Agency interaction Confidential Submissions—To Informed Drug Development through existing channels (e.g., Type C submit a comment with confidential Approaches meeting requests, critical path information that you do not wish to be innovation meetings). made publicly available, submit your AGENCY: Food and Drug Administration, ADDRESSES: Comments about this pilot comments only as a written/paper HHS. program can be submitted until May 17, submission. You should submit two ACTION: Notice. 2018. You may submit comments about copies total. One copy will include the the MIDD pilot meetings program as information you claim to be confidential SUMMARY: The sixth iteration of the follows: with a heading or cover note that states Prescription Drug User Fee Act (PDUFA ‘‘THIS DOCUMENT CONTAINS VI), incorporated as part of the FDA Electronic Submissions CONFIDENTIAL INFORMATION.’’ The Reauthorization Act of 2017 (FDARA), Submit electronic comments in the Agency will review this copy, including highlights the goal of advancing model- following way: the claimed confidential information, in informed drug development (MIDD). • Federal eRulemaking Portal: its consideration of comments. The The Food and Drug Administration https://www.regulations.gov. Follow the second copy, which will have the (FDA or Agency) is announcing a pilot instructions for submitting comments. claimed confidential information program that affords sponsors or Comments submitted electronically, redacted/blacked out, will be available applicants who are selected for including attachments, to https:// for public viewing and posted on participation the opportunity to meet www.regulations.gov will be posted to https://www.regulations.gov. Submit with Agency staff to discuss MIDD the docket unchanged. Because your both copies to the Dockets Management approaches in medical product comment will be made public, you are Staff. If you do not wish your name and development. Meetings under the pilot solely responsible for ensuring that your contact information to be made publicly program will be conducted by FDA’s comment does not include any available, you can provide this Center for Drug Evaluation and Research confidential information that you or a information on the cover sheet and not (CDER) and Center for Biologics third party may not wish to be posted, in the body of your comments and you Evaluation and Research (CBER) during such as medical information, your or must identify this information as fiscal years 2018 to 2022. This pilot anyone else’s Social Security number, or ‘‘confidential.’’ Any information marked program is being conducted to fulfill confidential business information, such as ‘‘confidential’’ will not be disclosed

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except in accordance with 21 CFR 10.20 applied, MIDD approaches can improve III. Procedures and Submission and other applicable disclosure law. For clinical trial efficiency, increase the Information more information about FDA’s posting probability of regulatory success, and A. General Information of comments to public dockets, see 80 optimize drug dosing/therapeutic FR 56469, September 18, 2015, or access individualization in the absence of The MIDD pilot program will be the information at: https://www.gpo.gov/ dedicated trials. jointly administered by CDER’s Office of fdsys/pkg/FR-2015-09-18/pdf/2015- Clinical Pharmacology, in the Office of The goal of the early meeting Translational Sciences, which is the 23389.pdf. discussions granted under this pilot Docket: For access to the docket to point of contact for all communications program is to provide advice on how for CDER products, and CBER’s Office of read background documents or the specific, proposed MIDD approaches electronic and written/paper comments Biostatistics and Epidemiology, which can be used in a specific drug received, go to https:// is the point of contact for all development program. FDA has www.regulations.gov and insert the communications for CBER products. committed to accepting two to four docket number, found in brackets in the meeting requests quarterly each fiscal B. How To Submit a Meeting Request heading of this document, into the year. The meetings granted will include and Meeting Package ‘‘Search’’ box and follow the prompts an initial and followup meeting on the Meeting requests should be submitted and/or go to the Dockets Management same drug development issues within electronically to the relevant application Staff, 5630 Fishers Lane, Rm. 1061, the span of approximately 120 days. (i.e., PIND, IND) with ‘‘MIDD Pilot Rockville, MD 20852. Program Meeting Request for CDER’’ FOR FURTHER INFORMATION CONTACT: The listed eligibility factors and procedures outlined in this Federal (CDER applications) or ‘‘MIDD Pilot CDER: Yvonne Knight, Center for Program Meeting Request for CBER’’ Drug Evaluation and Research, Food Register notice reflect the current thinking at the time of publication. (CBER applications) in the subject line. and Drug Administration, 10903 New Information about providing regulatory Hampshire Ave., Bldg. 51, Rm. 2142, Processes may be revised and will be communicated as this pilot program submissions in electronic format is Silver Spring, MD 20993–0002, 301– available at: https://www.fda.gov/Drugs/ evolves. The most current pilot program 796–2133, [email protected], DevelopmentApprovalProcess/ eligibility factors and procedures may with the subject line ‘‘MIDD Pilot FormsSubmissionRequirements/ be found on the MIDD Pilot Program Meetings Program for CDER.’’ %20ElectronicSubmissions/ website: https://www.fda.gov/Drugs/ CBER: Jason Claeys, Center for ucm153574.htm. Biologics Evaluation and Research, DevelopmentApprovalProcess/ Food and Drug Administration, 10903 DevelopmentResources/ C. Content and Format of the Meeting New Hampshire Ave., Bldg. 71, Rm. ucm600311.htm. Request 1223, Silver Spring, MD 20993–0002, II. Eligibility and Selection for Include the following information in 240–402–8589, jason.claeys@ Participation in the MIDD Pilot the meeting request (no more than three fda.hhs.gov, with the subject line Program to four pages): ‘‘MIDD Pilot Meetings Program for 1. Product name. CBER.’’ The requester should be a drug/ 2. Application number. 3. Chemical name and structure. SUPPLEMENTARY INFORMATION: biologics development company (interested consortia or software/device 4. Proposed indication(s) or context of I. Background developer should come in partnership product development. 5. Brief statement of the purpose and Under FDARA FDA agreed, in with a drug development company) and objectives of the meeting. The statement accordance with the ‘‘PDUFA have an investigational new drug should include a brief background of the application (IND) or pre-IND (PIND) Reauthorization Performance Goals and MIDD issues underlying the agenda. Procedures Fiscal Years 2018 Through number for the relevant program. 6. MIDD approach(es) considered for 2022: I. Ensuring the Effectiveness of the Recognizing that FDA will learn both the product under development and Human Drug Review Program, Part J. from the number and types of how MIDD can assess uncertainties Enhancing Regulatory Decision Tools to submissions received for consideration about issues (e.g., dosing, duration, Support Drug Development and into the pilot program, FDA welcomes patient selection) in a way that can Review’’ to provide information on how submissions related to any relevant inform regulatory decision-making. a sponsor can apply to participate in a MIDD topics. However, given that the 7. List of issues for discussion with pilot meetings program with FDA to Agency expects to grant two to four the Agency about the specific MIDD discuss MIDD approaches (https:// meeting requests per quarter as part of proposed approach for the applicable www.fda.gov/downloads/ForIndustry/ the pilot program, the Agency will drug development program. UserFees/PrescriptionDrugUserFee/ initially prioritize selecting requests that UCM511438.pdf). focus on: D. Content and Format of the Meeting Information Package FDA is announcing this pilot • Dose selection or estimation (e.g., meetings program to satisfy the above- for dose/dosing regimen selection or Sponsors or applicants whose meeting mentioned commitment and to facilitate refinement). requests are granted as part of the pilot MIDD approaches. This excludes • program should submit a meeting statistical designs involving complex Clinical trial simulation (e.g., based information package electronically with adaptations, Bayesian methods, or other on drug-trial-disease models to inform ‘‘MIDD Pilot Program Meeting Package features requiring computer simulations the duration of a trial, select appropriate for CDER’’ (CDER applications) or to determine the operating response measures, predict outcomes). ‘‘MIDD Pilot Program Meeting Package characteristics of a confirmatory clinical • Predictive or mechanistic safety for CBER’’ (CBER applications) in the trial. MIDD approaches use a variety of evaluation (e.g., use of systems subject line no later than 30 days before quantitative methods to help balance pharmacology/mechanistic models for each (initial and followup) meeting. the risks and benefits of drug products predicting safety or identifying critical This meeting package should include in development. When successfully biomarkers of interest). the following information:

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1. Product name. DEPARTMENT OF HEALTH AND Service Act (PHS Act) (42 U.S.C. 2. Application number. HUMAN SERVICES 262(a)). Section 351(a) requires that manufacturers of biological products, 3. Chemical name and structure. Food and Drug Administration which include blood and blood 4. Proposed indication(s) or context of [Docket No. FDA–2017–N–6931] components intended for further product development. manufacturing into products, have a 5. Background section that includes a Agency Information Collection license, issued upon a demonstration brief history of the development Activities; Submission for Office of that the product is safe, pure, and potent and that the manufacturing program and the events leading up to Management and Budget Review; establishment meets all applicable the meeting, and the status of product Comment Request; Current Good standards, including those prescribed in development. Manufacturing Practices and Related Regulations for Blood and Blood the FDA regulations designed to ensure 6. Proposed agenda, including Components; and Requirements for the continued safety, purity, and estimated times needed for discussion Donation Testing, Donor Notification, potency of the product. In addition, of each agenda item. and ‘‘Lookback’’ under section 361 of the PHS Act (42 7. List of questions for discussion U.S.C. 264), by delegation from the AGENCY: Food and Drug Administration, with a brief summary for each question Secretary of Health and Human HHS. Services, FDA may make and enforce to explain the need or context for the ACTION: Notice. regulations necessary to prevent the question. introduction, transmission, or spread of 8. Drug development issue (e.g., SUMMARY: The Food and Drug communicable diseases from foreign dosing, clinical trial design, safety Administration (FDA, we, or Agency) is countries into the States or possessions, prediction), including the proposed announcing that a proposed collection or from one State or possession into any MIDD approach to the solution, of information has been submitted to the other State or possession. information to support discussion (e.g., Office of Management and Budget Section 351(j) of the PHS Act states a description of the data used for (OMB) for review and clearance under that the Federal Food, Drug, and developing the models, model the Paperwork Reduction Act of 1995. Cosmetic Act (FD&C Act) also applies to development, simulation plan, results), DATES: Fax written comments on the biological products. Blood and blood and how the Agency can help guide any collection of information by May 17, components for transfusion or for next steps relative to the regulatory 2018. further manufacturing into products are drugs, as that term is defined in section decision making process, which should ADDRESSES: To ensure that comments on 201(g)(1) of the FD&C Act (21 U.S.C. be summarized and clearly articulated the information collection are received, 321(g)(1)). Because blood and blood with any supporting data imperative to OMB recommends that written components are drugs under the FD&C comments be faxed to the Office of the discussion. Act, blood and plasma establishments Information and Regulatory Affairs, must comply with the provisions and E. Meeting Summaries OMB, Attn: FDA Desk Officer, Fax: 202– related regulatory scheme of the FD&C 395–7285, or emailed to oira_ A meeting summary will be sent to Act. For example, under section 501 of [email protected]. All the requester within 60 days of each the FD&C Act (21 U.S.C. 351), drugs are comments should be identified with the meeting. deemed ‘‘adulterated’’ if the methods OMB control number 0910–0116. Also used in their manufacturing, processing, IV. Paperwork Reduction Act of 1995 include the FDA docket number found packing, or holding do not conform to in brackets in the heading of this current good manufacturing practice This notice refers to collections of document. information that are subject to review by (CGMP) and related regulations. FOR FURTHER INFORMATION CONTACT: Ila The CGMP regulations (part 606) (21 the Office of Management and Budget S. Mizrachi, Office of Operations, Food CFR part 606) and related regulations (OMB) under the Paperwork Reduction and Drug Administration, Three White implement FDA’s statutory authority to Act of 1995 (44 U.S.C. 3501–3520). The Flint North, 10A–12M, 11601 ensure the safety, purity, and potency of collection of information resulting from Landsdown St., North Bethesda, MD blood and blood components. The formal meetings between sponsors or 20852, 301–796–7726, PRAStaff@ public health objective in testing human applicants and FDA has been approved fda.hhs.gov. blood donations for evidence of relevant under OMB control number 0910–0429. transfusion-transmitted infections and SUPPLEMENTARY INFORMATION: In The collection of information in 21 CFR in notifying donors is to prevent the compliance with 44 U.S.C. 3507, FDA part 312 (INDs) has been approved transmission of relevant transfusion- has submitted the following proposed under OMB control number 0910–0014. transmitted infections. For example, the collection of information to OMB for ‘‘lookback’’ requirements are intended Dated: April 12, 2018. review and clearance. to help ensure the continued safety of Leslie Kux, Current Good Manufacturing Practices the blood supply by providing necessary Associate Commissioner for Policy. and Related Regulations for Blood and information to consignees of blood and [FR Doc. 2018–08010 Filed 4–16–18; 8:45 am] Blood Components; and Requirements blood components and appropriate BILLING CODE 4164–01–P for Donation Testing, Donor notification of recipients of blood Notification, and ‘‘Lookback’’ components that are at increased risk for transmitting human immunodeficiency OMB Control Number 0910–0116— virus (HIV) or hepatitis C virus (HCV) Extension infection. All blood and blood components The information collection introduced or delivered for introduction requirements in the CGMP, donation into interstate commerce are subject to testing, donor notification, and section 351(a) of the Public Health ‘‘lookback’’ regulations provide FDA

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with the necessary information to 606.145(c)) requires transfusion services appropriate system’’ requires the perform its duty to ensure the safety, to notify certain blood collection collecting establishment to design purity, and potency of blood and blood establishments concerning bacterial standard operating procedures (SOPs) to components. These requirements contamination of platelets and other identify and quarantine all blood and establish accountability and traceability additional information. In table 3, FDA blood components previously collected in the processing and handling of blood estimates that for the approximately from a donor who later tests reactive for and blood components and enable FDA 4,961 transfusion services, there would evidence of HIV or HCV infection, or to perform meaningful inspections. be 1,400 total notifications per year to when the collecting establishment is The recordkeeping requirements serve blood collection establishments (700 made aware of other reliable test results preventive and remedial purposes. The notifications that platelets are or information indicating evidence of third-party disclosure requirements bacterially contaminated and 700 HIV or HCV infection. Within 3 identify various blood and blood notifications per year concerning the calendar days of the donor testing components and important properties of identity or non-identity of the species of reactive by an HIV or HCV screening the product, demonstrate that the CGMP the contaminating organism). test or the collecting establishment requirements have been met, and Section 610.40(c)(1)(ii), in brief, becoming aware of other reliable test facilitate the tracing of a product back requires that each donation dedicated to results or information, the collecting to its original source. The reporting a single identified recipient be labeled establishment must, among other things, requirements inform FDA of certain as required under § 606.121 (21 CFR notify consignees to quarantine all information that may require immediate 606.121) and with a label containing the identified previously collected in-date corrective action. name and identifying information of the blood and blood components Under the reporting requirements, recipient. The information collection (§§ 610.46(a)(1)(ii)(B) and § 606.170(b) (21 CFR 606.170(b)), in requirements under § 606.121 are part of 610.47(a)(1)(ii)(B)) and, within 45 days, brief, requires that facilities notify usual and customary business practice. notify the consignees of supplemental FDA’s Center for Biologics Evaluation Section 610.40(h)(2)(ii)(C) and (D), in test results, or the results of a reactive and Research (CBER), as soon as brief, require an establishment to label screening test if there is no available possible after a complication of blood certain reactive human blood and blood supplemental test that is approved for collection or transfusion is confirmed to components with the appropriate such use by FDA (§§ 610.46(a)(3) and be fatal. The collecting facility is screening test results for evidence of 610.47(a)(3)). required to report donor fatalities, and infection due to the identified relevant the compatibility testing facility is to transfusion-transmitted infection(s), Consignees also must establish, report recipient fatalities. The regulation and, if they are intended for further maintain, and follow an appropriate also requires the reporting facility to manufacturing use into products, to system for performing HIV and HCV submit a written report of the include a statement on the label ‘‘lookback’’ when notified by the investigation within 7 days after the indicating the exempted use specifically collecting establishment that they have fatality. In fiscal year 2016, FDA approved by FDA. Also, received blood and blood components received 81 fatality reports. § 610.40(h)(2)(vi) requires each donation previously collected from donors who Section 610.40(g)(2) (21 CFR of human blood or blood components, later tested reactive for evidence of HIV 610.40(g)(2)) requires an establishment excluding Source Plasma, that tests or HCV infection, or when the collecting to obtain written approval from FDA to reactive by a screening test for syphilis establishment is made aware of other ship human blood or blood components and is determined to be a biological reliable test results or information for further manufacturing use prior to false positive to be labeled with both indicating evidence of HIV or HCV completion of testing for evidence of test results. infection in a donor (§§ 610.46(b) and infection due to relevant transfusion- Section 610.42(a) (21 CFR 610.42(a)) 610.47(b)). This provision for a system transmitted infections. requires a warning statement requires the consignee to establish SOPs Section 610.41(b) (21 CFR 610.41(b)) ‘‘indicating that the product was for, among other things, notifying allows for a previously deferred donor manufactured from a donation found to transfusion recipients of blood and to subsequently be found to be an be reactive by a screening test for blood components, or the recipient’s eligible donor of blood and blood evidence of infection due to the physician of record or legal components by a requalification method identified relevant transfusion- representative, when such action is or process found acceptable for such transmitted infection(s)’’ in the labeling indicated by the results of the purposes by FDA. for medical devices containing human supplemental (additional, more specific) Section 610.40(h)(2)(ii)(A), in brief, blood or a blood component found to be tests or a reactive screening test if there requires an establishment to obtain reactive by a screening test for evidence is no available supplemental test that is written approval from FDA to use or of infection due to a relevant approved for such use by FDA, or if ship human blood or blood components transfusion-transmitted infection(s) or under an investigational new drug found to be reactive by a screening test syphilis. application (IND) or an investigational for evidence of infection due to a In brief, §§ 610.46 and 610.47 (21 CFR device exemption (IDE), is exempted for relevant transfusion-transmitted 610.46 and 610.47) require blood such use by FDA. The consignee must infection(s) or collected from a donor collecting establishments to establish, make reasonable attempts to perform the deferred under § 610.41(a). maintain, and follow an appropriate notification within 12 weeks of receipt In addition, § 630.35(b) (21 CFR system for performing HIV and HCV of the supplemental test result or receipt 630.35(b)) allows for a previously ‘‘lookback’’ when: (1) A donor tests of a reactive screening test result when deferred donor, deferred for reasons reactive for evidence of HIV or HCV there is no available supplemental test other than § 610.41(a), to become infection or (2) the collecting that is approved for such use by FDA, requalified for donation by a method or establishment becomes aware of other or if under an IND or IDE, is exempted process found acceptable for such reliable test results or information for such use by FDA (§§ 610.46(b)(3) purpose by FDA. indicating evidence of HIV or HCV and 610.47(b)(3)). The burden for the Under the third-party disclosure infection (see §§ 610.46(a)(1) and recordkeeping requirements under requirements, § 606.145(c) (21 CFR 610.47(a)(1)). The requirement for ‘‘an §§ 610.46(a) and (b) and 610.47(a) and

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(b) are included under § 606.100 (21 unit of blood and blood components can presents no undue medical risk to the CFR 606.100). be clearly traced, § 606.160 (21 CFR transfusion recipient. Section 630.40(a) (21 CFR 630.40(a)) 606.160) requires that legible and In addition to the CGMP regulations requires an establishment to make indelible contemporaneous records of in part 606, the regulations in 21 CFR reasonable attempts to notify any donor each such step be made and maintained part 630 that include requirements for who has been deferred as required by for no less than 10 years. Section blood and blood components intended § 610.41(a), or who has been determined 606.160(b)(1)(viii) requires records of for transfusion or further manufacturing not to be eligible as a donor. Section the quarantine, notification, testing, and use and in 21 CFR part 640 that require 630.40(d)(1) requires an establishment disposition performed under the HIV additional standards for certain blood to provide certain information to the and HCV ‘‘lookback’’ provisions. and blood products are as follows: 21 referring physician of an autologous Furthermore, § 606.160(b)(1)(x) requires CFR 630.5(b)(1)(i) and(d); 630.10(c)(1) donor who is deferred based on the a blood collection establishment to and (2); 630.10(f)(2) and (4); results of tests as described in § 610.41. maintain records of notification of 630.10(g)(2)(i); 630.15(a)(1)(ii)(A) and Under the recordkeeping donors deferred or determined not to be (B); 630.15(b)(2), (b)(7)(i) and (iii); requirements, § 606.100(b), in brief, eligible for donation, including 630.20(a) and (b); 640.21(e)(4); requires that written SOPs be appropriate followup. Section 640.25(b)(4) and (c)(1); 640.31(b); maintained for all steps to be followed 606.160(b)(1)(xi) requires an 640.33(b); 640.51(b); 640.53(b) and (c); in the collection, processing, establishment to maintain records of 640.56(b) and (d); 640.65(b)(2)(i); compatibility testing, storage, and notification of the referring physician of 640.66; 640.71(b)(1); 640.72; 640.73; and distribution of blood and blood a deferred autologous donor, including 640.76(a) and (b). The information components used for transfusion and appropriate followup. collection requirements and estimated further manufacturing purposes. Section Section 606.165 (21 CFR 606.165), in burdens for these regulations are 606.100(c) requires the review of all brief, requires that distribution and included in the part 606 burden records pertinent to the lot or unit of receipt records be maintained to estimates, as described in tables 1 and blood prior to release or distribution. facilitate recalls, if necessary. 2. Any unexplained discrepancy or the Respondents to this collection of Section 606.170(a) requires records to failure of a lot or unit of final product information are licensed and unlicensed be maintained of any reports of to meet any of its specifications must be blood establishments that collect blood complaints of adverse reactions arising thoroughly investigated, and the and blood components, including as a result of blood collection or investigation, including conclusions Source Plasma and Source Leukocytes, transfusion. Each such report must be and followup, must be recorded. inspected by FDA, and transfusion thoroughly investigated, and a written In brief, § 606.110(a) (21 CFR services inspected by Centers for report, including conclusions and 606.110(a)) provides that the use of Medicare and Medicaid Services (CMS). plateletpheresis and leukapheresis followup, must be prepared and Based on information received from procedures to obtain a product for a maintained. Section 606.170(a) also CBER’s database systems, there are specific recipient may be at variance requires that when an investigation approximately 569 licensed Source with the additional standards for that determines that the product caused the Plasma establishments and specific product if, among other things, transfusion reaction, copies of all such approximately 1,054 licensed blood the physician determines and written reports must be forwarded to collection establishments, for an documents that the donor’s health and maintained by the manufacturer or estimated total of 1,623 (569 + 1,054) permits plateletpheresis or collecting facility. licensed blood collection leukapheresis. Section 606.110(b) Section 610.40(g)(1) requires an establishments. Also, there are an requires establishments to request prior establishment to appropriately estimated total of 680 unlicensed, approval from CBER for plasmapheresis document a medical emergency for the registered blood collection of donors who do not meet donor release of human blood or blood establishments for an approximate total requirements. The information components prior to completion of of 2,303 collection establishments (569 collection requirements for § 606.110(b) required testing. + 1,054 + 680 = 2,303 establishments). are approved under OMB control Under § 630.15(a)(1)(ii)(B) (21 CFR Of these establishments, approximately number 0910–0338 and, therefore, are 630.15(a)(1)(ii)(B)), FDA requires that 901 perform plateletpheresis and not reflected in the tables of this for a dedicated donation based on the leukopheresis. These establishments document. intended recipient’s documented annually collect approximately 53.3 Section 606.151(e) (21 CFR exceptional medical need, the million units of Whole Blood and blood 606.151(e)) requires that SOPs for responsible physician determines and components, including Source Plasma compatibility testing include procedures documents that the health of the donor and Source Leukocytes, and are to expedite transfusion in life- would not be adversely affected by required to follow FDA ‘‘lookback’’ threatening emergencies; records of all donating. procedures. In addition, there are such incidents must be maintained, Under § 630.20(c) (21 CFR 630.20(c)), another estimated 4,961 establishments including complete documentation a collection establishment may collect that fall under the Clinical Laboratory justifying the emergency action, which blood and blood components from a Improvement Amendments of 1988 must be signed by a physician. donor who is determined to be not (CLIA) (formerly referred to as facilities Section 606.171 (21 CFR 606.171) eligible to donate under any provision approved for Medicare reimbursement) requires establishments to establish and of § 630.10(e) and (f) or § 630.15(a), if that transfuse blood and blood maintain procedures related to product the donation is restricted for use solely components. deviations. The burden for the by a specific transfusion recipient based The following reporting, recordkeeping requirements under on documented exceptional medical recordkeeping, and disclosure estimates § 606.171 are included under § 606.100. need and the responsible physician are based on information provided by So that each significant step in the determines and documents that the industry, CMS, and FDA experience. collection, processing, compatibility donor’s health permits the collection Based on information from industry, we testing, storage, and distribution of each procedure, and that the donation estimate that there are approximately

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38.3 million donations of Source Plasma indicating that the product was collecting establishments to notify from approximately 2 million donors manufactured from a donation found to onsite and to explain why the donor is and approximately 15 million donations be reactive for the identified relevant determined not to be suitable for of Whole Blood and apheresis Red transfusion-transmitted infection(s). In donating. Based on such available Blood Cells including approximately addition, on the rare occasion when a information, we estimate that two-thirds 34,500 (approximately 0.23 percent of human blood or blood component with (1,156) of the 1,734 blood collecting 15 million) autologous donations, from a reactive screening test is the only establishments provided onsite approximately 10.9 million donors. component available for a medical additional information and counseling Assuming each autologous donor makes device that does not require a reactive to a donor determined not to be eligible an average of 1.1 donations, FDA component, then a warning statement for donation as usual and customary estimates that there are approximately must be affixed to the medical device. business practice. Consequently, we 31,364 autologous donors (34,500 To account for this rare occasion under estimate that only approximately one- autologous/1.1 average donations). § 610.42(a), we estimate that the third, or 578 of the 1,734 blood FDA estimates that approximately warning statement would be necessary collecting establishments would need to 0.19 percent (21,000/10,794,000) of the no more than once a year. provide, under § 630.40(a), additional 72,000 donations that are donated FDA estimates that approximately information and onsite counseling to the specifically for the use of an identified 3,021 repeat donors will test reactive on estimated 429,000 (one-third of recipient would be tested under the a screening test for HIV. We also approximately 1,287,000) ineligible dedicated donors’ testing provisions in estimate that an average of three donors. § 610.40(c)(1)(ii). components was made from each It is estimated that another 4.5 percent Under § 610.40(g)(2) and (h)(2)(ii)(A), donation. Under § 610.46(a)(1)(ii)(B) and of 10 million potential donors (450,000 Source Leukocytes, a licensed product (a)(3), this estimate results in 9,063 donors) are deferred annually based on that is used in the manufacture of (3,021 × 3) notifications of the HIV test results. We estimate that interferon, which requires rapid screening test results to consignees by approximately 95 percent of the preparation from blood, is currently collecting establishments for the establishments that collect 99 percent of shipped prior to completion of testing purpose of quarantining affected blood the blood and blood components notify for evidence of relevant transfusion- and blood components, and another donors who have reactive test results for transmitted infections. Shipments of 9,063 (3,021 × 3) notifications to HIV, hepatitis B virus, HCV, human T- Source Leukocytes are approved under consignees of subsequent test results. lymphotropic virus, and syphilis as a biologics license application and each We estimate that approximately 4,961 usual and customary business practice. shipment does not have to be reported consignees will be required under Consequently, 5 percent of the 1,623 to the Agency. Based on information § 610.46(b)(3) to notify transfusion licensed establishments (81) collecting 1 from CBER’s database system, FDA recipients, their legal representatives, or percent (4,050) of the deferred donors receives less than one application per physicians of record an average of 0.35 (405,000) would notify donors under year from manufacturers of Source times per year resulting in a total § 630.40(a). Leukocytes. However, for calculation number of 1,755 (585 confirmed As part of usual and customary purposes, we are estimating one positive repeat donors × 3) notifications. business practice, collecting application annually. Also under § 610.46(b)(3), we estimate establishments notify an autologous According to CBER’s database system, and include the time to gather test donor’s referring physician of reactive there are approximately 15 licensed results and records for each recipient test results obtained during the donation manufacturers that ship known reactive and to accommodate multiple attempts process required under § 630.40(d)(1). human blood or blood components to contact the recipient. However, we estimate that under § 610.40(h)(2)(ii)(C) and (D). FDA Furthermore, we estimate that approximately 5 percent of the 1,054 estimates that each manufacturer would approximately 6,799 repeat donors per blood collection establishments (53) ship an estimated 1 unit of human blood year would test reactive for antibody to may not notify the referring physicians or blood components per month (12 per HCV. Under § 610.47(a)(1)(ii)(B) and of the estimated 2 percent of 31,364 year) that would require two labels; one (a)(3), collecting establishments would autologous donors with the initial as reactive for the appropriate screening notify the consignee two times for each reactive test results (627) as their usual test under § 610.40(h)(2)(ii)(C), and the of the 20,397 (6,799 × 3 components) and customary business practice. other stating the exempted use components prepared from these The recordkeeping chart reflects the specifically approved by FDA under donations, once for quarantine purposes estimate that approximately 95 percent § 610.40(h)(2)(ii)(D). and again with additional HCV test of the recordkeepers, which collect 99 Based on information received from results for a total of 40,794 (20,397 × 2) percent of the blood supply, have industry, we estimate that notifications as an annual ongoing developed SOPs as part of their approximately 7,544 donations will test burden. Under § 610.47(b)(3), we customary and usual business practice. reactive by a screening test for syphilis estimate that approximately 4,961 Establishments may minimize burdens and be determined to be biological false consignees would notify approximately associated with CGMP and related positives by additional testing annually. 2,050 recipients or their physicians of regulations by using model standards These units would be labeled according record annually. developed by industries’ accreditation to § 610.40(h)(2)(vi). Based on industry estimates, organizations. These accreditation Human blood or a blood component approximately 14.3 percent of organizations represent almost all with a reactive screening test, as a approximately 9 million potential registered blood establishments. component of a medical device, is an donors (1,287,000 donors) who come to Under § 606.160(b)(1)(x), we estimate integral part of the medical device, e.g., donate annually are determined not to the total annual records based on the a positive control for an in vitro be eligible for donation prior to approximately 1,287,000 donors diagnostic testing kit. It is usual and collection because of failure to satisfy determined not to be eligible to donate customary business practice for eligibility criteria. It is the usual and and each of the estimated 1,692,000 manufacturers to include on the customary business practice of (1,287,000 + 405,000) donors deferred container label a warning statement approximately 1,734 (1,054 + 680) blood based on reactive test results for

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evidence of infection because of donors under § 630.35(b). FDA also day notice requesting public comment relevant transfusion-transmitted estimates the average time for each on the proposed collection of infections. Under § 606.160(b)(1)(xi), submission. information. Although one comment only the 1,734 registered blood FDA permits the shipment of untested was received, it was not responsive to establishments collect autologous or incompletely tested human blood or the four collection of information topics donations and, therefore, are required to blood components in rare medical solicited and therefore will not be notify referring physicians. We estimate emergencies and when appropriately discussed in this document. documented (§ 610.40(g)(1)). We that 4.5 percent of the 31,364 autologous The average burden per response donors (1,411) will be deferred under estimate the recordkeeping under § 610.40(g)(1) to be minimal with one or (hours) and average burden per § 610.41, which in turn will lead to the fewer occurrences per year. The recordkeeping (hours) are based on notification of their referring physicians. reporting of test results to the consignee estimates received from industry or FDA Under § 610.41(b), FDA estimates that in § 610.40(g) is part of the usual and experience with similar reporting or there would be 25 submissions for customary business practice of blood recordkeeping requirements. requalification of donors. In addition, establishments. FDA estimates the burden of this FDA estimates that there would be only In the Federal Register of January 23, collection of information as follows: three notifications for requalification of 2018 (83 FR 3165), FDA published a 60-

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

Number of Average 21 CFR section Number of responses per Total annual burden per Total hours respondents respondent responses response

606.170(b) 2 ...... 81 1 81 20 1,620 610.40(g)(2) ...... 1 1 1 1 1 610.41(b) ...... 1,623 0.015 25 7 175 610.40(h)(2)(ii)(A) ...... 1 1 1 1 1 630.35(b) ...... 1,623 0.002 3 7 21

Total ...... 1,818 1 There are no capital costs or operating and maintenance costs associated with this collection of information. 2 The reporting requirement in § 640.73, which addresses the reporting of fatal donor reactions, is included in the estimate for § 606.170(b).

TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1

Number of Average 21 CFR section/activity Number of records per Total annual burden per Total hours recordkeepers recordkeeper records recordkeeping

606.100(b) 2 ...... 5 363 1 363 24 ...... 8,712 606.100(c) ...... 5 363 10 3,630 1 ...... 3,630 606.110(a) 3 ...... 6 45 1 45 0.5 (30 min) ... 23 606.151(e) ...... 5 363 12 4,356 0.08 (5 min.) .. 348 606.160 4 ...... 5 363 1,055.096 383,000 0.75 (45 min.) 287,250 606.160(b)(1)(viii) HIV consignee notification ...... 1,734 10.4533 18,126 0.17 (10 min.) 3,081 0.17 (10 min.) 4,961 3.6537 18,126 3,081 606.160(b)(1)(viii) HCV consignee notification ...... 1,734 23.5259 40,794 0.17 (10 min.) 6,935 0.17 (10 min) 4,961 8.2229 40,794 6,935 HIV recipient notification ...... 4,961 0.3538 1,755 0.17 (10 min.) 298 HCV recipient notification ...... 4,961 0.4132 2,050 0.17 (10 min.) 349 606.160(b)(1)(x) ...... 2,303 734.6939 1,692,000 0.05 (3 min.) .. 84,600 606.160(b)(1)(xi) ...... 1,734 0.8137 1,411 0.05 (3 min.) .. 71 606.165 ...... 5 363 1,055.096 383,000 0.08 (5 min.) .. 30,640 606.170(a) ...... 5 363 12 4,356 1 ...... 4,356 610.40(g)(1) ...... 2,303 1 2,303 0.5 (30 min.) .. 1,152 630.15(a)(1)(ii)(B) ...... 1,734 1 1,734 1 ...... 1,734 630.20(c) ...... 1,734 1 1,734 1 ...... 1,734

Total ...... 444,930 1 There are no capital costs or operating and maintenance costs associated with this collection of information. 2 The recordkeeping requirements in §§ 606.171, 610.46(a) and (b), 610.47(a) and (b), 630.5(d), 630.10(c)(1) and (2), and 640.66, which ad- dress the maintenance of SOPs, are included in the estimate for § 606.100(b). 3 The recordkeeping requirements in § 640.27(b), which address the maintenance of donor health records for the plateletpheresis, are included in the estimate for § 606.110(a). 4 The recordkeeping requirements in §§ 606.110(a)(2); 630.5(b)(1)(i); 630.109(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); 630.15(b)(2); 640.65(b)(2)(i); 640.71(b)(1); 640.72; 640.73; and 640.76(a) and (b), which address the maintenance of various records are included in the estimate for § 606.160. 5 Five percent of establishments that fall under CLIA that transfuse blood and components and FDA-registered blood establishments (0.05 × 4,961 + 2,303 = 363). 6 Five percent of plateletpheresis and leukopheresis establishments (0.05 × 901 = 45).

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TABLE 3—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1

Number of Number of disclosures Total annual Average 21 CFR section respondents per disclosures burden per Total hours respondent disclosure

606.145(c) ...... 4,961 0.2822 1,400 0.02...... 28 606.170(a) ...... 2 363 12 4,356 0.5 (30 min.) .. 2,178 610.40(c)(1)(ii) ...... 2,303 0.0595 137 0.08 (5 min.) .. 11 610.40(h)(2)(ii)(C) and (h)(2)(ii)(D) ...... 15 12 180 0.20 (12 min.) 36 610.40(h)(2)(vi) ...... 2,303 3.28 7,554 0.08 (5 min.) .. 604 610.42(a) ...... 1 1 1 1 ...... 1 610.46(a)(1)(ii)(B) ...... 1,734 5.2266 9,063 0.17 (10 min.) 1,541 610.46(a)(3) ...... 1,734 5.2266 9,063 0.17 (10 min.) 1,541 610.46(b)(3) ...... 4,961 0.3538 1,755 1...... 1,755 610.47(a)(1)(ii)(B) ...... 1,734 11.7630 20,397 0.17 (10 min.) 3,467 610.47(a)(3) ...... 1,734 11.7630 20,397 0.17 (10 min.) 3,467 610.47(b)(3) ...... 4,961 0.4132 2,050 1...... 2,050 630.40(a) 3 ...... 578 742.214 429,000 0.08 (5 min.) .. 34,320 630.40(a) 4 ...... 81 50 4,050 1.5 ...... 6,075 630.40(d)(1) ...... 53 11.83 627 1...... 627

Total ...... 57,701 1 There are no capital costs or operating and maintenance costs associated with this collection of information. 2 Five percent of establishments that fall under CLIA that transfuse blood and components and FDA-registered blood establishments (0.05 × 4,961 + 2,303 = 363). 3 Notification of donors determined not to be eligible for donation based on failure to satisfy eligibility criteria. 4 Notification of donors deferred based on reactive test results for evidence of infection due to relevant transfusion-transmitted infections.

The burden for this information Maryland 20857, Room 5E29. The and Commerce. The Committee also collection has changed since the last conference call-in number: 1–800–857– develops, publishes, and implements OMB approval. Because of a slight 9729 and Passcode: 1318150. The performance measures and guidelines decrease in the number of blood webinar link is https:// for longitudinal evaluations of programs establishments during the last 3 years, hrsa.connectsolutions.com/actpcmd. authorized under Title VII, Part C, of the FDA has decreased our recordkeeping FOR FURTHER INFORMATION CONTACT: PHSA, and recommends appropriation and third-party disclosure burden Anyone requesting information levels for programs under this Part. estimates. regarding the ACTPCMD should contact During the May 3–4, 2018, meeting, Dated: April 12, 2018. Dr. Kennita R. Carter, Designated ACTPCMD will review the impact of the Leslie Kux, Federal Official (DFO), Division of Title VII, Section 747 and oral health Associate Commissioner for Policy. Medicine and Dentistry, Bureau of training programs, and make [FR Doc. 2018–07972 Filed 4–16–18; 8:45 am] Health Workforce, HRSA, in one of recommendations on funding and BILLING CODE 4164–01–P three ways: (1) Send a request to the appropriation levels. In addition, the following address: Dr. Kennita R. Carter, Committee will identify its strategic DFO, Division of Medicine and priorities for the coming year, and DEPARTMENT OF HEALTH AND Dentistry, HRSA, 5600 Fishers Lane, discuss issues related to pending HUMAN SERVICES Room 15N–116, Rockville, MD 20857; Committee reports on the integration of (2) call 301–945–3505; or (3) send an behavioral health into primary care and Health Resources and Services email to [email protected]. oral health training, and clinical trainee Administration SUPPLEMENTARY INFORMATION: and faculty well-being and resilience. ACTPCMD provides advice and Information about ACTPCMD and the Advisory Committee on Training in recommendations to the Secretary of the agenda for this meeting is located on the Primary Care Medicine and Dentistry Department of Health and Human ACTPCMD website at https:// AGENCY: Health Resources and Service Services on policy, program www.hrsa.gov/advisory-committees/ Administration (HRSA), Department of development, and other matters of primarycare-dentist/index.html. Please Health and Human Services (HHS). significance concerning the activities note that agenda items are subject to ACTION: Notice of Federal Advisory under section 747 of Title VII of the change as priorities dictate. Committee meeting. Public Health Service Act (PHSA). Members of the public will have the ACTPCMD prepares an annual report opportunity to provide comments. SUMMARY: In accordance with the describing the activities of the Public participants may submit written Federal Advisory Committee Act, this Committee, including findings and statements in advance of the scheduled notice announces that the Advisory recommendations made by the meeting. Oral comments will be Committee on Training in Primary Care Committee concerning the activities honored in the order they are requested Medicine and Dentistry (ACTPCMD) under section 747, as well as training and may be limited as time allows. will hold a public meeting. programs in oral health and dentistry. Requests to make oral comments or DATES: Thursday, May 3, 2018, from The annual report is submitted to the provide written comments to the 8:30 a.m. to 5:00 p.m. and Friday, May Secretary and ranking members of the ACTPCMD should be sent to Dr. Carter, 4, 2018, from 8:30 a.m. to 2:00 p.m. ET. Senate Committee on Health, Education, DFO, using the contact information ADDRESSES: The address for the meeting Labor and Pensions, and the House of above at least three business days prior is 5600 Fishers Lane, Rockville, Representatives Committee on Energy to the meeting.

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The building at 5600 Fishers Lane, adoption and processes related to Place: Bureau of Labor Statistics, Janet Rockville, MD 20857, requires a security updating standards and operating rules Norwood Conference and Training screening on entry. To facilitate access for electronic administrative Center, Postal Square Building, 2 to the building, please contact Dr. Carter transactions (e.g., claims, eligibility, Massachusetts Ave NE, Room G440, at the contact information listed above. electronic funds transfer). The agenda Washington, DC 20212 (Entrance on Individuals who plan to attend and and plans for the July meeting First Street across from Union Station). need special assistance, such as sign examining health terminology & Status: Open. There will be a public language interpretation or other vocabulary development, maintenance, comment period during the final 15 reasonable accommodations, should and dissemination processes will be minutes of the subcommittee meeting. notify Dr. Carter at the address and discussed together with a draft Purpose: Health Insurance Portability phone number listed above at least 10 environmental scan report. The and Accountability Act (HIPAA) days prior to the meeting. Committee will continue development legislation from 1996, as amended,1 Amy P. McNulty, of its Health Information Privacy & directed the Secretary of HHS to publish Security Beyond HIPAA project Acting Director, Division of the Executive regulations adopting administrative Secretariat. focusing on clinical registries as a use standards, code sets and identifiers to case. The Committee also will discuss [FR Doc. 2018–07910 Filed 4–16–18; 8:45 am] support the exchange of electronic any recent developments resulting from BILLING CODE 4165–15–P health information between covered the initial wave of the Medicare Card entities. The standards are for retail Project roll out. pharmacy and medical transactions. DEPARTMENT OF HEALTH AND The times and topics are subject to NCVHS is working on the HUMAN SERVICES change. Please refer to the posted development of a standards update and agenda for any updates. adoption roadmap (the predictability National Committee on Vital and Health Contact Persons for More Information: roadmap), in collaboration with Statistics: Meeting Substantive program information may industry stakeholders and the Standards be obtained from Rebecca Hines, MHS, Pursuant to the Federal Advisory Development Organizations (SDOs). The Committee Act, the Department of Executive Secretary, NCVHS, National purpose of this roadmap is to improve Health and Human Services (HHS) Center for Health Statistics, Centers for the predictability of the update and announces the following advisory Disease Control and Prevention, 3311 adoption process of the standards and committee meeting. Toledo Road, Hyattsville, Maryland operating rules. It is the intent of the Name: National Committee on Vital 20782, telephone (301) 458–4715. collaboration effort to identify the and Health Statistics (NCVHS), Full Summaries of meetings and a roster of barriers to updating and adopting Committee Meeting. Committee members are available on the standards and make constructive, Date and Times: Tuesday, May 15, home page of the NCVHS website: actionable recommendations for all 2018: 9:00 a.m.–5:00 p.m. (EDT), www.ncvhs.hhs.gov, where further parties, so that covered entities can Wednesday, May 16, 2018: 8:30 a.m.– information including an agenda and more effectively conduct their business, 2:45 p.m. (EDT). instructions to access the audio operational and technical strategic Place: U.S. Department of Health and broadcast of the meetings will also be planning. Human Services, Hubert H. Humphrey posted. NCVHS held a visioning exercise with Building, 200 Independence Avenue Should you require reasonable the Standards Development SW, Rm. 705A, Washington, DC 20201. accommodation, please contact the CDC Organizations (SDOs) in August 2017, Status: Open. Office of Equal Employment and developed a set of draft action steps Purpose: At the May 15–16, 2018 Opportunity on (770) 488–3210 as soon and recommendations. The next step meeting, the Committee will hear as possible. towards finalizing recommendations for presentations, hold discussions on Dated: April 10, 2018. the Secretary, is to convene a group of several health data policy topics and Laina Bush, Chief Information Officers (CIOs) who work on activities outlined in the work with the standards and operating NCVHS 2018 workplan. Anticipated Deputy Assistant Secretary for Planning and Evaluation, Office of the Assistant Secretary rules as end users, with health care action items during this meeting include for Planning and Evaluation. leaders from various fields of health a letter to the Secretary and a summary [FR Doc. 2018–07928 Filed 4–16–18; 8:45 am] care technology. The CIOs and health report of the hearing held September care innovators will exchange BILLING CODE 4151–05–P 2017 on the topic of the national vital information based on their experience records and vital statistics systems. In and expertise. The CIOs will discuss addition, a letter to the Secretary DEPARTMENT OF HEALTH AND their changing business and technology regarding the Committee’s HUMAN SERVICES needs specifically as these pertain to the recommendations resulting from the standards that have been adopted under March Standards Subcommittee Hearing National Committee on Vital and Health HIPAA such as claims, eligibility, on NCPDP Updates will be considered Statistics: Meeting referrals and authorizations. Some for approval. The Office of the National individuals will share their experience Coordinator (ONC) will give an update Pursuant to the Federal Advisory using the standards day to day, and to and the Committee will discuss its Committee Act, the Department of increase efficiencies in their collaboration with ONC and its advisory Health and Human Services (HHS) organizations. Other participants will committee HITAC. Subcommittee announces the following advisory share their experience implementing or activities for discussion include the CIO committee meeting. seeing innovative technology being used Forum to be held in May and the Name: National Committee on Vital for the exchange of electronic health Predictability Roadmap as part of the and Health Statistics (NCVHS), care information. Standards Subcommittee’s project to Standards Subcommittee Meeting. identify possible approaches to improve Date and Times: Thursday, May 17, 1 Along with Section 1104(c) of the Patient predictability and improvements in the 2018: 9:00 a.m.–4:30 p.m. (EDT). Protection and Affordable Care Act (ACA) of 2010.

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During the second part of the forum, & Medicaid Services, Office of relationship between the United States the group will engage in an open Information Technology, Division of (U.S.) and Indian Tribes. Through the discussion about the roadmap themes National Standards, 7500 Security TSGP, Tribes negotiate with the IHS to and develop additional action items and Boulevard, Baltimore, Maryland, 21244, assume Programs, Services, Functions, recommendations for the Secretary. The telephone (443) 615–1309. Summaries and Activities (PSFAs), or portions roadmap themes and their problem of meetings and a roster of Committee thereof, which gives Tribes the authority statements are listed below: members are available on the NCVHS to manage and tailor health care 1. Standards Development and update website: www.ncvhs.hhs.gov, where programs in a manner that best fits the process. Frequency of updates to further information including an agenda needs of their communities. standards and operating rules is not and instructions to access the live audio Participation in the TSGP affords aligned with industry business and broadcast of the meetings will also be Tribes the most flexibility to tailor technical changes and does not enable posted. health care PSFAs and is one of three covered entities, trading partners, or Should you require reasonable ways that Tribes can choose to obtain business associates to take advantage of accommodation, please contact the CDC health care from the Federal developments in technology. Office of Equal Employment Government for their citizens. 2. Governance, or oversight of the Opportunity on (770) 488–3210 as soon Specifically, Tribes can choose to: (1) standards review process (currently the as possible. Receive health care services directly Designated Standards Maintenance from the IHS, (2) contract with the IHS Dated: April 10, 2018. Organization or DSMO process to administer individual programs and established through regulation). Current Laina Bush, services the IHS would otherwise coordinating body (i.e., the DSMO) is Deputy Assistant Secretary for Planning and provide (referred to as Title I Self- charged with oversight of standards Evaluation, Office of the Assistant Secretary Determination Contracting, and (3) revision priorities but may be operating for Planning and Evaluation. compact with the IHS to assume control with too narrow a charter or lacking the [FR Doc. 2018–07926 Filed 4–16–18; 8:45 am] over health care programs the IHS authority and resources to be effective. BILLING CODE 4151–05–P would otherwise provide (referred to as 3. Federal regulatory process to adopt Title V Self-Governance Compacting or new versions of standards. The Federal the TSGP). These options are not process for adoption of standards and DEPARTMENT OF HEALTH AND exclusive and Tribes may choose to operating rules is lengthy, of HUMAN SERVICES combine options based on their unpredictable duration and contains Indian Health Service individual needs and circumstances. numerous checks and balances that The TSGP is a tribally driven duplicate similar processes within the Office of Tribal Self-Governance; initiative, and strong Federal-Tribal standards development organizations. Negotiation Cooperative Agreement partnerships are essential to the The lack of predictability and timeliness program’s success. The IHS established jeopardizes the smooth adoption and Announcement Type: New—Limited the OTSG to implement the Tribal Self- uptake of standards and operating rules Competition Governance authorities under the once they are developed and published Funding Announcement Number: HHS– ISDEAA. The primary OTSG functions by the SDO. 2018–IHS–TSGN–0001 are to: (1) Serve as the primary liaison 4. Data harmonization. The lack of Catalog of Federal Domestic Assistance and advocate for Tribes participating in data cohesion due to inconsistencies in Number: 93.444 the TSGP, (2) develop, direct, and data dictionaries and data elements Key Dates implement TSGP policies and across SDOs jeopardizes procedures, (3) provide information and interoperability. Application Deadline Date: June 17, technical assistance to Self-Governance 5. Inclusion of non-covered entities 2018 Tribes, and (4) advise the IHS Director under HIPAA. Covered entities include Review Date: June 25–29, 2018 on compliance with TSGP policies, providers, health plans and health care Earliest Anticipated Start Date: July 15, regulations, and guidelines. Each IHS clearinghouses. Vendors and other 2018 Area has an Agency Lead Negotiator business associates are not covered Tribal Resolutions Due Date: June 17, (ALN), designated by the IHS Director to entities but often play a role in the 2018 act on his or her behalf, who has exchange and/or processing of the I. Funding Opportunity Description authority to negotiate Self-Governance adopted standards. The Federal Compacts and Funding Agreements government is limited in its authority Statutory Authority (FA). Prospective Tribes interested in over non-covered entities. This impacts The Indian Health Service (IHS) participating in the TSGP should the use of standards in a variety of ways, Office of Tribal Self-Governance (OTSG) contact their respective ALN to begin from costs to actual utilization. is accepting applications for Negotiation the Self-Governance planning process. The times and topics are subject to Cooperative Agreements for the Tribal Also, Tribes currently participating in change. Please refer to the posted Self-Governance Program (TSGP). This the TSGP, who are interested in agenda for any updates. program is authorized under: Title V of expanding existing or adding new Contact Persons for More Information: the Indian Self-Determination and PSFAs, should also contact their Substantive program information may Education Assistance Act (ISDEAA), 25 respective ALN to discuss the best be obtained from Rebecca Hines, MHS, U.S.C. 5383(e). This program is methods for expanding or adding new Executive Secretary, NCVHS, National described in the Catalog of Federal PSFAs. Center for Health Statistics, Centers for Domestic Assistance (CFDA) under Purpose Disease Control and Prevention, 3311 93.444. Toledo Road, Hyattsville, Maryland The purpose of this Negotiation 20782, telephone (301) 458–4715. Background Cooperative Agreement is to provide Information pertaining to meeting The TSGP is more than an IHS Tribes with resources to help defray the content may be obtained from Lorraine program; it is an expression of the costs associated with preparing for and Doo, MSW, MPH, Centers for Medicare Government-to-Government engaging in TSGP negotiations. TSGP

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negotiations are a dynamic, evolving, those PSFAs. A thorough planning in planning, organizes meetings and tribally driven process that requires phase improves timeliness and efficient between the Tribe and the IHS, and careful planning, preparation and negotiations and ensures that the Tribe coordinates the Agency’s response to sharing of precise, up-to-date is fully prepared to assume the transfer Tribal questions during the negotiations information by both Tribal and Federal of IHS PSFAs to the Tribal health process. The ALN role requires detailed parties. Because each Tribal situation is program. knowledge of the IHS, awareness of unique, a Tribe’s successful transition During pre-negotiations, the Tribal current policy and practice, and into the TSGP, or expansion of their and Federal negotiation teams review understanding of the rights and current program, requires focused and discuss issues identified during the authorities available to a Tribe under discussions between the Federal and planning phase. Pre-negotiations Title V of the ISDEAA. Tribal negotiation teams about the provide an opportunity for the Tribe In post-negotiations, after the Tribe’s specific health care concerns and the IHS to identify and discuss Compact, FA and all negotiations are and plans. One of the hallmarks of the issues directly related to the Tribe’s complete, the documents are signed by TSGP is the collaborative nature of the Compact, FA and Tribal shares. They the authorizing Tribal official and negotiations process, which is designed may take the form of a formal meeting submitted to the ALN who reviews the to: (1) Enable a Tribe to set its own or a series of informal meetings or final package to ensure each document priorities when assuming responsibility conference calls. accurately reflects what was negotiated. for IHS PSFAs, (2) observe and respect In advance of final negotiations, the Once the ALN completes this review, the Government-to-Government Tribe should work with the IHS to then the final package is submitted to relationship between the U.S. and each secure the following: (1) Program titles the OTSG to be prepared for the IHS Tribe, and (3) involve the active and descriptions, (2) financial tables Director’s signature, provided that no participation of both Tribal and IHS and information, (3) information related outstanding issues delay or prevent representatives, including the OTSG. to the identification and justification of signature. After the Compact and FA Negotiations are a method of residuals, and (4) the basis for have been signed by both parties, they determining and agreeing upon the determining Tribal shares (distribution become legally binding and enforceable terms and provisions of a Tribe’s formula). The Tribe may also wish to agreements. A signed Compact and FA Compact and FA, the implementation discuss financial materials that show are necessary for the payment process to documents required for the Tribe to estimated funding for next year, and the begin. The negotiating Tribe then enter into the TSGP. The Compact sets increases or decreases in funding it may becomes a ‘‘Self-Governance Tribe’’ and forth the general terms of the receive in the current year, as well as a participant in the TSGP. Government-to-Government the basis for those changes. Acquiring a Negotiation Cooperative Having reviewed the draft documents relationship between the Tribe and the Agreement is not a prerequisite to enter and funding tables, at final negotiations Secretary of the U.S. Department of the TSGP. A Tribe may use other both negotiation teams work together in resources to develop and negotiate its Health and Human Services (HHS). The good faith to determine and agree upon FA: (1) Describes the length of the the terms and provisions of the Tribe’s Compact and FA. See 42 CFR 137.26. agreement (whether it will be annual or Compact and FA. Negotiations are not Tribes that receive a Negotiation multi-year), (2) identifies the PSFAs, or an allocation process; they provide an Cooperative Agreement are not portions thereof, the Tribe will assume, opportunity to mutually review and obligated to participate in Title V and (3) specifies the amount of funding discuss budget and program issues. As may choose to delay or decline associated with the Tribal assumption, issues arise, both negotiations teams participation or expansion in the TSGP. and (4) includes terms required by work through the issues to reach Limited Competition Justification Federal statute and other terms agreed agreement on the final documents. to by the parties. Both documents are There are various entities involved There is limited competition under required to participate in the TSGP and throughout the negotiations process. For this announcement because the they are mutually negotiated agreements example, a Tribal government selects its authorizing legislation restricts that become legally binding and representative(s) for negotiations and eligibility to Tribes that meet specific mutually enforceable after both parties the Tribal negotiations team, which may criteria identified in Section III. sign the documents. Either document include a Tribal leader from the Eligibility Criteria, 1. Eligibility, A. See can be renegotiated at the request of the governing body, a Tribal health director, 25 U.S.C. 5383(e); 42 CFR 137.10 and 42 Tribe. technical and program staff, legal CFR 137.24–26. The negotiations process has four counsel, and other consultants. II. Award Information major stages, including: (1) Planning, (2) Regardless of the composition of the pre-negotiations, (3) negotiations, and Tribal team, Tribal representatives must Type of Award (4) post-negotiations. Title V of the have decision making authority from the Cooperative Agreement. ISDEAA requires that a Tribe or Tribal Tribal governing body to successfully organization complete a planning phase negotiate and agree to the provisions Estimated Funds Available to the satisfaction of the Tribe. The within the agreements. The Federal The total amount of funding planning phase must include legal and negotiations team is led by the ALN and identified for the current fiscal year (FY) budgetary research and internal Tribal may include area and headquarters staff, 2018 is approximately $240,000. Government planning and including staff from the OTSG, the Individual award amounts are organizational preparation relating to Office of Finance and Accounting, and anticipated to be $48,000. The amount the administration of health care the Office of the General Counsel. The of funding available for awards issued programs. See 25 U.S.C. 5383(d). The ALN is the only member of the Federal under this announcement are subject to planning phase is critical to negotiations negotiations team with delegated the availability of appropriations and and helps Tribes make informed authority to negotiate on behalf of the budgetary priorities of the Agency. The decisions about which PSFAs to assume IHS Director. The ALN is the designated IHS is under no obligation to make and what organizational changes or official that provides Tribes with Self- awards that are selected for funding modifications are necessary to support Governance information, assists Tribes under this announcement.

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Anticipated Number of Awards III. Eligibility Information Meeting the eligibility criteria for a Negotiation Cooperative Agreement 1. Eligibility Approximately five awards will be does not mean that a Tribe/Tribal issued under this program To be eligible for the New Limited Organization is eligible for participation announcement. Competition Negotiation Cooperative in the IHS TSGP under Title V of the Period of Performance Agreement under this announcement, ISDEAA. See 25 U.S.C. 5383; 42 CFR an applicant must: 137.15–23. For additional information The period of performance is for one (A) Be an ‘‘Indian Tribe’’ as defined on the eligibility for the IHS TSGP, year and runs from July 15, 2018, to July in 25 U.S.C. 5304(e); a ‘‘Tribal please visit the ‘‘Eligibility and 14, 2019. Organization’’ as defined in 25 U.S.C. Funding’’ page on the OTSG website Cooperative Agreement 5304(l); or an ‘‘Inter-Tribal Consortium: located at: http://www.ihs.gov/ as defined at 42 CFR 137.10. However, SelfGovernance. Cooperative agreements awarded by Alaska Native Villages or Alaska Native Note: Please refer to Section IV.2 the Department of Health and Human Village Corporations are not eligible if (Application and Submission Information/ Services (HHS) are administered under they are located within the area served Subsection 2, Content and Form of the same policies as a grant. However, by an Alaska Native regional health Application Submission) for additional proof the IHS is required to have substantial entity. See Consolidated Appropriations of applicant status documents required, such programmatic involvement in the Act, 2014, Public Law 113–76. By as Tribal resolutions, proof of non-profit status, etc. project during the entire award segment. statute, the Native Village of Eyak, Below is a detailed description of the Eastern Aleutian Tribes, and the 2. Cost Sharing or Matching level of involvement required for both Council for Athabascan Tribal the IHS and the grantee. The IHS will Governments have also been deemed The IHS does not require matching be responsible for activities listed under Alaska Native regional health entities funds or cost sharing for grants or section A and the grantee will be and therefore are eligible to apply. cooperative agreements. responsible for activities listed under Those Alaska Tribes not represented by 3. Other Requirements section B as stated: a Self-Governance Tribal consortium FA If application budgets exceed the within their area may still be considered Substantial Involvement Description for highest dollar amount outlined under to participate in the TSGP. the Cooperative Agreement the ‘‘Estimated Funds Available’’ (B) Submit Tribal resolution(s) from section within this funding A. IHS Programmatic Involvement the appropriate governing body of each announcement, the application will be Indian Tribe to be served by the considered ineligible and will not be (1) Provide descriptions of PSFAs and ISDEAA Compact authorizing the associated funding at all organizational reviewed for further consideration. If submission of the Negotiation deemed ineligible, the IHS will not levels (Service Unit, Area, and Cooperative Agreement. Tribal consortia Headquarters), including funding return the application. The applicant applying for a TSGP Negotiation will be notified by email by the Division formulas and methodologies related to Cooperative Agreement shall submit determining Tribal shares. of Grants Management (DGM) of this Tribal Council resolutions from each decision. (2) Meet with Negotiation Cooperative Tribe in the consortium. Tribal Agreement recipients to provide resolutions can be attached to the Tribal Resolution(s) program information and discuss electronic online application. Submit Tribal resolution(s) from the methods currently used to manage and (C) Demonstrate for three fiscal years, appropriate governing body of the deliver health care. financial stability and financial Indian Tribe to be served by the (3) Identify and provide statutes, management capability. The Indian ISDEAA Compact authorizing the regulations, and policies that provide Tribe must provide evidence that, for submission of a Negotiation Cooperative authority for administering IHS the three fiscal years prior to requesting Agreement application. Tribal consortia programs. participation in the TSGP, the Indian applying for a TSGP Negotiation (4) Provide technical assistance on the Tribe has had no uncorrected significant Cooperative Agreement shall submit IHS budget, Tribal shares, and other and material audit exceptions in the Tribal Council resolutions from each topics as needed. required annual audit of the Indian Tribe in the consortium. Tribal Tribe’s Self-Determination Contracts or resolutions can be attached to the B. Grantee Cooperative Agreement Self-Governance FAs with any Federal electronic online application. Award Activities Agency. See 25 U.S.C. 5383; 42 CFR An official signed Tribal resolution 137.15–23. must be received by the DGM prior to (1) Determine the PSFAs that will be For Tribes or Tribal organizations (T/ a Notice of Award (NoA) being issued negotiated into the Tribe’s Compact and TO) that expended $750,000 or more to any applicant selected for funding. FA. Prepare and discuss each Program, ($500,000 for fiscal years ending after However, if an official signed Tribal Service Function and Activity in December 31, 2003) in Federal awards, resolution cannot be submitted with the comparison to the current level of the OTSG shall retrieve the audits electronic application submission prior services provided so that an informed directly from the Federal Audit to the official application deadline date, decision can be made on new or Clearinghouse. then a draft Tribal resolution is expanded program assumption. For T/TO that expended less than acceptable and must be submitted by (2) Identify Tribal shares associated $750,000 ($500,000 for fiscal years the deadline in order for the application with the PSFAs that will be included in ending after December 31, 2003) in to be considered complete and eligible the FA. Federal awards, the T/TO must provide for review. The draft Tribal resolution is (3) Develop the terms and conditions evidence of the program review not in lieu of the required signed that will be set for in both the Compact correspondence from IHS or Bureau of resolution, but is acceptable until a and FA to submit to the ALN prior to Indian Affairs officials. See 42 CFR signed resolution is received. If an negotiations. 137.21–23. official signed Tribal resolution is not

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received by DGM when funding • Organizational Chart (optional). Knowledge and expertise to assume or decisions are made, then a (NoA) will • Documentation of current Office of expand PSFAs, and (2) the not be issued to that applicant and they Management and Budget (OMB) administrative infrastructure to support will not receive any IHS funds until Financial Audit. the assumption of PSFAs. Identify the such time as they have submitted a Acceptable forms of documentation need for assistance and how the signed resolution to the Grants include: Negotiation Cooperative Agreement Management Specialist listed in this Æ Email confirmation from Federal would benefit the health activities the Funding Announcement. Audit Clearinghouse (FAC) that audits Tribe is preparing to assume or expand. An applicant submitting Tribal were submitted; or resolution(s) after the initial application Æ Face sheets from audit reports. Part B: Program Planning and submission due date is required to These can be found on the FAC website: Evaluation (4 page limit) ensure the information was received by https://harvester.census.gov/facdissem/ Section 1: Program Plans the IHS by obtaining documentation Main.aspx. Project Objective(s), Work Plan and confirming delivery (i.e., FedEx Approach Public Policy Requirements tracking, postal return receipt, etc.). State in measureable terms the All Federal wide public policies objectives and appropriate activities to IV. Application and Submission apply to IHS grants and cooperative Information achieve the following Negotiation agreements with exception of the Cooperative Agreement recipient award 1. Obtaining Application Materials Discrimination Policy. activities: The application package and detailed Requirements for Project and Budget (A) Determine the PSFAs that will be instructions for this announcement can Narratives negotiated into the Tribe’s Compact and FA. Prepare and discuss each Program, be found at: http://www.Grants.gov or A. Project Narrative: This narrative Service, Function, and Activity in http://www.ihs.gov/dgm/funding/. should be a separate Word document Questions regarding the electronic comparison to the current level of that is not to exceed ten pages and must application process may be directed to services provided so that an informed be single-spaced, type written, have Mr. Paul Gettys at (301) 443–2114 or decision can be made on new or consecutively numbered pages, use (301) 443–5204. expanded program assumption. black type not smaller than 12 points, (B) Identify Tribal shares associated 2. Content and Form Application and be printed on one side only of with the PSFAs that will be included in Submission 1 2″ ″ standard size 8 ⁄ x 11 paper. the FA. The applicant must include the Be sure to succinctly answer all (C) Develop the terms and conditions project narrative as an attachment to the questions listed under the evaluation that will be set forth in both the application package. Mandatory criteria (refer to Section V.1, Evaluation Compact and FA to submit to the ALN documents for all applicants include: criteria in this announcement) and place prior to negotiations. • Table of contents. all responses and required information (D) Describe fully and clearly how the • Abstract (one page) summarizing in the correct section (noted below), or Tribe’s proposal will result in an the project. they will not be considered or scored. improved approach to managing the • Application forms: These narratives will assist the Æ PSFAs to be assumed or expanded. SF–424, Application for Federal Objective Review Committee (ORC) in Include how the Tribe plans to Assistance. becoming familiar with the applicant’s demonstrate improved health services to Æ SF–424A, Budget Information— activities and accomplishments prior to the community and incorporate the Non-Construction Programs. this possible cooperative agreement proposed timelines for negotiations. Æ SF–424B, Assurances—Non- award. If the narrative exceeds the page Organizational Capabilities, Key Construction Programs. limit, then only the first ten pages will Personnel, and Qualifications Line Item Budget and Narrative (must be reviewed. The ten page limit for the be single-spaced and not exceed five narrative does not include the work Describe the organizational structure pages). of the Tribe and its ability to manage the • plan, standard forms, Tribal resolutions, Project Narrative (must be single- table of contents, budget, budget proposed project. Include resumes or spaced and not exceed ten pages). justifications, narratives, and/or other position descriptions of key staff Æ Background information on the appendix items. showing requisite experience and organization. There are three parts to the narrative: expertise. If applicable, include resumes Æ Proposed scope of work, objectives, Part A—Program Information; Part B— and scope of work for consultants that and activities that provide a description Program Planning and Evaluation; and demonstrate experience and expertise of what will be accomplished, including Part C—Program Report. See below for relevant to the project. a one-page Timeframe Chart. Section 2: Program Evaluation • Tribal Resolution(s). additional details about what must be • Letters of Support from included in the narrative. Describe fully and clearly how the organization’s Board of Directors. The page limitations below are for improvements that will be made by the • 501(c)(3) Certificate (if applicable). each narrative and budget submitted. Tribe to manage the health care system • Biographical sketches for all Key Part A: Program Information (4 page and identify the anticipated or expected Personnel. limit) benefits for the Tribe. Define the criteria • Contractor/Consultant resumes or to be used to evaluate objectives qualifications and scope of work. Section 1: Needs associated with the project. • Disclosure of Lobbying Activities Introduction and Need for Assistance Part C: Program Report (2 page limit) (SF–LLL). Demonstrate that the Tribe has • Certification Regarding Lobbying conducted previous Self-Governance Section 1: Describe major (GG-Lobbying Form). planning activities by clearly stating the accomplishments over the last 24 • Copy of current Negotiated Indirect results of what was learned during the months associated with the goals of this Cost rate (IDC) agreement (required in planning process. Explain how the Tribe announcement. Please identify and order to receive IDC). has determined it has the: (1) describe significant health related

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program accomplishments associated • Tribes can apply for a Planning will not be accepted for processing or with the delivery of quality health Cooperative Agreement and a considered for funding. Applicants that services. This section should highlight Negotiation Cooperative Agreement in do not adhere to the timelines for major program achievements over the the same cycle, so long as the project System for Award Management (SAM) last 24 months. proposals are different for each and/or http://www.Grants.gov Section 2: Describe major activities application. Tribes cannot apply for registration or that fail to request timely over the last 24 months. Please provide both the Planning Cooperative assistance with technical issues will not an overview of significant program Agreement and the Negotiation be considered for a waiver to submit a activities associated with the delivery of Cooperative Agreement within the same paper application. quality health services over the last 24 grant cycle with the same proposed Please be aware of the following: months. This section should address project. • Please search for the application significant program activities and • Only one Negotiation grant/ package in http://www.Grants.gov by include those related to the cooperative agreement will be awarded entering the CFDA number or the accomplishments listed in the previous per applicant per grant cycle under this Funding Opportunity Number. Both section. announcement. numbers are located in the header of • IHS will not acknowledge receipt of this announcement. B. Budget Narrative (5 page limit) applications. • If you experience technical This narrative must include a line 6. Electronic Submission Requirements challenges while submitting your item budget with a narrative application electronically, please justification for all expenditures All applications must be submitted contact Grants.gov support directly at: identifying reasonable allowable, electronically. Please use the http:// [email protected] or (800) 518–4726. allocable costs necessary to accomplish www.Grants.gov website to submit an Customer Support is available to the goals and objectives as outlined in application electronically and select the address questions 24 hours a day, 7 days the project narrative. Budget should ‘‘Search Grants’’ link on the homepage. a week (except on Federal holidays). match the scope of work described in Follow the instructions for submitting • Upon contacting Grants.gov, obtain the project narrative. an application under the Package tab. a tracking number as proof of contact. Electronic copies of the application may The tracking number is helpful if there 3. Submission Dates and Times not be submitted as attachments to are technical issues that cannot be Applications must be submitted email messages addressed to IHS resolved and a waiver from the agency electronically through Grants.gov by employees or offices. must be obtained. • 11:59 p.m. Eastern Daylight Time (EDT) Waiver Request Applicants are strongly encouraged on the Application Deadline Date listed not to wait until the deadline date to in the Key Dates section on page one of If the applicant needs to submit a begin the application process through this announcement. Any application paper application instead of submitting Grants.gov as the registration process for received after the application deadline electronically through Grants.gov, a SAM and Grants.gov could take up to will not be accepted for processing, nor waiver must be requested. Prior fifteen working days. will it be given further consideration for approval must be requested and • Please use the optional attachment funding. Grants.gov will notify the obtained from Mr. Robert Tarwater, feature in Grants.gov to attach applicant via email if the application is Director, DGM, (see Section IV.6 below additional documentation that may be rejected. for additional information). A written requested by the DGM. If technical challenges arise and waiver request must be sent to • All applicants must comply with assistance is required with the [email protected] with a copy to any page limitation requirements electronic application process, contact [email protected]. The waiver described in this funding Grants.gov Customer Support via email must: (1) Be documented in writing announcement. to [email protected] or at (800) 518– (emails are acceptable), before • After electronically submitting the 4726. Customer Support is available to submitting a paper application, and (2) application, the applicant will receive address questions 24 hours a day, 7 days include clear justification for the need an automatic acknowledgment from a week (except on Federal holidays). If to deviate from the required electronic Grants.gov that contains a Grants.gov problems persist, contact Mr. Gettys grants submission process. tracking number. The DGM will ([email protected]), DGM Grant Once the waiver request has been download the application from Systems Coordinator, by telephone at approved, the applicant will receive a Grants.gov and provide necessary copies (301) 443–2114 or (301) 443–5204. confirmation of approval email to the appropriate agency officials. Please be sure to contact Mr. Gettys at containing submission instructions and Neither the DGM nor the OTSG will least ten days prior to the application the mailing address to submit the notify the applicant that the application deadline. Please do not contact the DGM application. A copy of the written has been received. until you have received a Grants.gov approval must be submitted along with • Email applications will not be tracking number. In the event you are the hardcopy of the application that is accepted under this announcement. mailed to DGM. Paper applications that not able to obtain a tracking number, Dun and Bradstreet (D&B) Data call the DGM as soon as possible. are submitted without a copy of the signed waiver from the Director of the Universal Numbering System (DUNS) 4. Intergovernmental Review DGM will not be reviewed or considered All IHS applicants and grantee Executive Order 12372 requiring for funding. The applicant will be organizations are required to obtain a intergovernmental review is not notified via email of this decision by the DUNS number and maintain an active applicable to this program. Grants Management Officer of the DGM. registration in the SAM database. The Paper applications must be received by DUNS number is a unique 9-digit 5. Funding Restrictions the DGM no later than 5:00 p.m., EDT, identification number provided by D&B • Pre-award costs are not allowable. on the Application Deadline Date listed which uniquely identifies each entity. • The available funds are inclusive of in the Key Dates section on page one of The DUNS number is site specific; direct and appropriate indirect costs. this announcement. Late applications therefore, each distinct performance site

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may be assigned a DUNS number. 1. Criteria demonstrate experience and expertise Obtaining a DUNS number is easy, and relevant to the project. A. Introduction and Need for Assistance there is no charge. To obtain a DUNS (25 points) E. Categorical Budget and Budget number, you may access it through Justification (10 points) http://fedgov.dnb.com/webform, or to Demonstrate that the Tribe has expedite the process, call (866) 705– conducted previous Self-Governance Submit a budget with a narrative 5711. planning activities by clearly stating the describing the budget request and All HHS recipients are required by the results of what was learned during the matching the scope of work described in Federal Funding Accountability and planning process. Explain how the Tribe the project narrative. Justify all Transparency Act of 2006, as amended has determined it has the: (1) expenditures identifying reasonable and (‘‘Transparency Act’’), to report Knowledge and expertise to assume or allowable costs necessary to accomplish information on sub-awards. expand PSFAs, and (2) the the goals and objectives as outlined in Accordingly, all IHS grantees must administrative infrastructure to support the project narrative. notify potential first-tier sub-recipients the assumption of PSFAs. Identify the Additional documents can be that no entity may receive a first-tier need for assistance and how the uploaded as Appendix Items in sub-award unless the entity has Negotiation Cooperative Agreement Grants.gov: provided its DUNS number to the prime would benefit the health activities the • Work plan, logic model and/or time grantee organization. This requirement Tribe is preparing to assume or expand. line for proposed objectives. ensures the use of a universal identifier • Position descriptions for key staff. to enhance the quality of information B. Project Objective(s), Work Plan and • Approach (25 points) Resumes of key staff that reflect available to the public pursuant to the current duties. Transparency Act. State in measurable terms the • Consultant or contractor proposed System for Award Management (SAM) objectives and appropriate activities to scope of work and letter of commitment achieve the following Planning Organizations that were not registered (if applicable). Cooperative Agreement recipient award • with Central Contractor Registration and Current Indirect Cost Agreement. activities: • have not registered with SAM will need Organizational chart. • to obtain a DUNS number first and then (1) Determine the PSFAs that will be Map of area identifying project access the SAM online registration negotiated into the Tribe’s Compact and location(s). • through the SAM home page at: https:// FA. Prepare and discuss each Program, Additional documents to support www.sam.gov (U.S. organizations will Service, Function and Activity in narrative (i.e. data tables, key news also need to provide an Employer comparison to the level of services articles, etc.). provided so that an informed decision Identification Number from the Internal 2. Review and Selection Revenue Service that may take an can be made on new or expanded additional 2–5 weeks to become active). program assumption. Each application will be prescreened Completing and submitting the (2) Identify Tribal shares associated by the DGM staff for eligibility and registration takes approximately one with the PSFAs that will be included in completeness as outlined in the funding hour to complete and SAM registration the FA. announcement. Applications that meet will take 3–5 business days to process. (3) Develop the terms and conditions the eligibility criteria shall be reviewed Registration with the SAM is free of that will be set forth in both the for merit by the ORC based on charge. Applicants may register online Compact and FA to submit to the ALN evaluation criteria in this funding at: https://www.sam.gov. prior to negotiations. Clearly describe announcement. The ORC could be Additional information on how the Tribe’s proposal will result in composed of both Tribal and Federal implementing the Transparency Act, an improved approach to managing the reviewers appointed by the IHS Program including the specific requirements for PSFAs to be assumed or expanded. to review and make recommendations DUNS and SAM, can be found on the Include how the Tribe plans to on these applications. The technical IHS Grants Management, Grants Policy demonstrate improved health care review process ensures selection of website: http://www.ihs.gov/dgm/ services to the community and quality projects in a national policytopics/. incorporate the proposed timelines for competition for limited funding. negotiations. Incomplete applications and V. Application Review Information applications that are non-responsive to C. Program Evaluation (25 points) The instructions for preparing the the eligibility criteria will not be application narrative also constitute the Describe fully the improvements that referred to the ORC. The applicant will evaluation criteria for reviewing and will be made by the Tribe to manage the be notified via email of this decision by scoring the application. Weights health care system and identify the the Grants Management Officer of the assigned to each section are noted in anticipated or expected benefits for the DGM. Applicants will be notified by parentheses. The ten page narrative Tribe. Define the criteria to be used to DGM, via email, to outline minor section should be written in a manner evaluate objectives associated with the missing components (i.e., budget that is clear to outside reviewers project. narratives, audit documentation, key unfamiliar with prior related activities contact form) needed for an otherwise D. Organizational Capabilities, Key of the applicant. It should be well complete application. All missing Personnel and Qualifications (15 points) organized, succinct, and contain all documents must be sent to DGM on or information necessary for reviewers to Describe the organizational structure before the due date listed in the email understand the project fully. Points will of the Tribe and its ability to manage the of notification of missing documents be assigned to each evaluation criteria proposed project. Include resumes or required. adding up to a total of 100 points. A position descriptions of key staff To obtain a minimum score for minimum score of 60 points is required showing requisite experience and funding by the ORC, applicants must for funding. Points are assigned as expertise. If applicable, include resumes address all program requirements and follows: and scope of work for consultants that provide all required documentation.

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VI. Award Administration Information 2. Administrative Requirements reports within the time allowed may result in suspension or termination of 1. Award Notices Cooperative agreements are administered in accordance with the an active grant, withholding of The NoA is a legally binding following regulations and policies: additional awards for the project, or document signed by the Grants A. The criteria as outlined in this other enforcement actions such as Management Officer and serves as the program announcement. withholding of payments or converting official notification of the grant award. B. Administrative Regulations for to the reimbursement method of payment. Continued failure to submit The NoA will be initiated by the DGM Grants: required reports may result in one or in our grant system, GrantSolutions • Uniform Administrative both of the following: (1) The (https://www.grantsolutions.gov). Each Requirements for HHS Awards, located imposition of special award provisions; entity that is approved for funding at 45 CFR part 75, located on the U.S. Government Publishing Office website and (2) the non-funding or non-award of under this announcement will need to other eligible projects or activities. This request or have a user account in at: http://www.ecfr.gov/cgi-bin/text- idx?node=pt45.1.75. requirement applies whether the GrantSolutions in order to retrieve their delinquency is attributable to the failure NoA. The NoA is the authorizing C. Grants Policy: • HHS Grants Policy Statement, of the grantee organization or the document for which funds are dispersed individual responsible for preparation to the approved entities and reflects the Revised 01/07, located at: http:// www.hhs.gov/sites/default/files/grants/ of the reports. Per DGM policy, all amount of Federal funds awarded, the grants/policies-regulations/ reports are required to be submitted purpose of the grant, the terms and hhsgps107.pdf. electronically by attaching them as a conditions of the award, the effective D. Cost Principles: ‘‘Grant Note’’ in GrantSolutions. date of the award, and the budget/ • Uniform Administrative Personnel responsible for submitting period of performance. Requirements for HHS Awards, ‘‘Cost reports will be required to obtain a login and password for GrantSolutions. Please Disapproved Applicants Principles,’’ located at 45 CFR part 75, subpart E. see the Agency Contacts list in section Applicants who received a score less E. Audit Requirements: VII for the systems contact information. The reporting requirements for this than the recommended funding level for • Uniform Administrative program are noted below. approval, 60 and were deemed to be Requirements for HHS Awards, ‘‘Audit disapproved by the ORC, will receive an Requirements,’’ located at 45 CFR part A. Progress Reports Executive Summary Statement from the 75, subpart F. Program progress reports are required OTSG within 30 days of the conclusion 3. Indirect Costs semi-annually. These reports must of the ORC outlining the strengths and include a brief comparison of actual weaknesses of their application. The This section applies to all grant accomplishments to the goals summary statement will be sent to the recipients that request reimbursement of established for the six month period, a Authorized Organizational indirect costs (IDC) in their grant summary of progress to date or, if Representative that is identified on the application. In accordance with HHS applicable, provide sound justification Grants Policy Statement, Part II–27, IHS face page (SF–424) of the application. for the lack of progress, and other requires applicants to obtain a current The OTSG will also provide additional pertinent information as required by the IDC rate agreement prior to award. The program office. A final report must be contact information as needed to rate agreement must be prepared in address questions and concerns as well submitted within 90 days of expiration accordance with the applicable cost of the budget or period of performance. as provide technical assistance if principles and guidance as provided by desired. the cognizant agency or office. A current B. Financial Reports Approved but Unfunded Applicants rate covers the applicable grant Federal Financial Report (FFR or SF– activities under the current award’s 425), Cash Transaction Reports are due Approved but unfunded applicants budget period. If the current rate is not 30 days after the close of every calendar that met the minimum scoring range on file with the DGM at the time of quarter to the Payment Management and were deemed by the ORC to be award, the IDC portion of the budget Services, HHS at: https://pms.psc.gov. It ‘‘Approved,’’ but were not funded due will be restricted. The restrictions is recommended that the applicant also to lack of funding, will have their remain in place until the current rate is send a copy of the FFR (SF–425) report applications held by DGM for a period provided to the DGM. to the Grants Management Specialist. of one year. If additional funding Generally, IDC rates for IHS grantees Failure to submit timely reports may becomes available during the course of are negotiated with the Division of Cost cause a disruption in timely payments FY 2018 the approved but unfunded Allocation (DCA) https://rates.psc.gov/ to the organization. application may be re-considered by the and the Department of the Interior Grantees are responsible and OTSG for possible funding. The (Interior Business Center) https:// accountable for accurate information applicant will also receive an Executive www.doi.gov/ibc/services/finance/ being reported on all required reports: indirect-Cost-Services/indian-tribes. For Summary Statement from the OTSG The Progress Reports and Federal questions regarding the indirect cost within 30 days of the conclusion of the Financial Report. policy, please call the Grants ORC. Management Specialist listed under C. Federal Sub-Award Reporting System Note: Any correspondence other than the ‘‘Agency Contacts’’ or the main DGM (FSRS) official NoA signed by an IHS grants office at (301) 443–5204. This award may be subject to the management official announcing to the Transparency Act sub-award and 4. Reporting Requirements project director that an award has been made executive compensation reporting to their organization is not an authorization The grantee must submit required requirements of 2 CFR part 170. to implement their program on behalf of the reports consistent with the applicable The Transparency Act requires the IHS. deadlines. Failure to submit required OMB to establish a single searchable

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database, accessible to the public, with index.html; and http://www.hhs.gov/ about criminal, civil, and administrative information on financial assistance civil-rights/index.html. Recipients of proceedings, and/or affirm that there is awards made by Federal agencies. The FFA also have specific legal obligations no new information to provide. This Transparency Act also includes a for serving qualified individuals with applies to NFEs that receive Federal requirement for recipients of Federal disabilities. Please see http:// awards (currently active grants, grants to report information about first- www.hhs.gov/civil-rights/for- cooperative agreements, and tier sub-awards and executive individuals/disability/index.html. procurement contracts) greater than compensation under Federal assistance Please contact the HHS OCR for more $10,000,000 for any period of time awards. information about obligations and during the period of performance of an IHS has implemented a Term of prohibitions under Federal civil rights award/project. Award into all IHS Standard Terms and laws at: https://www.hhs.gov/ocr/about- Mandatory Disclosure Requirements Conditions, NoAs and funding us/contact-us/index.html or call (800) announcements regarding the FSRS 368–1019 or TDD (800) 537–7697. Also As required by 2 CFR part 200 of the reporting requirement. This IHS Term of note it is an HHS Departmental goal to Uniform Guidance, and the HHS Award is applicable to all IHS grant and ensure access to quality, culturally implementing regulations at 45 CFR part cooperative agreements issued on or competent care, including long-term 75, effective January 1, 2016, the IHS after October 1, 2010, with a $25,000 services and supports, for vulnerable must require a non-Federal entity or an sub-award obligation dollar threshold populations. For further guidance on applicant for a Federal award to met for any specific reporting period. providing culturally and linguistically disclose, in a timely manner, in writing Additionally, all new (discretionary) appropriate services, recipients should to the IHS or pass-through entity all IHS awards (where the period of review the National Standards for violations of Federal criminal law performance is made up of more than Culturally and Linguistically involving fraud, bribery, or gratuity one budget period) and where: (1) The Appropriate Services in Health and violations potentially affecting the period of performance start date was Health Care at: https:// Federal award. October 1, 2010 or after, and (2) the minorityhealth.hhs.gov/omh/ Submission is required for all primary awardee will have a $25,000 browse.aspx?lvl=2&lvlid=53. applicants and recipients, in writing, to sub-award obligation dollar threshold Pursuant to 45 CFR 80.3(d), an the IHS and to the HHS Office of during any specific reporting period individual shall not be deemed Inspector General all information will be required to address the FSRS subjected to discrimination by reason of related to violations of Federal criminal reporting. his/her exclusion from benefits limited law involving fraud, bribery, or gratuity For the full IHS award term by Federal law to individuals eligible violations potentially affecting the implementing this requirement and for benefits and services from the IHS. Federal award. 45 CFR 75.113. additional award applicability Recipients will be required to sign the Disclosures must be sent in writing to: information, visit the DGM Grants HHS–690 Assurance of Compliance U.S. Department of Health and Human Policy website at: http://www.ihs.gov/ form which can be obtained from the Services, Indian Health Service, dgm/policytopics/. following website: http://www.hhs.gov/ Division of Grants Management, sites/default/files/forms/hhs-690.pdf, ATTN: Robert Tarwater, Director, D. Compliance With Executive Order and send it directly to the: U.S. 5600 Fishers Lane, Mail Stop: 09E70, 13166 Implementation of Services Department of Health and Human Rockville, MD 20857, (Include Accessibility Provisions for All Grant Services, Office of Civil Rights, 200 ‘‘Mandatory Grant Disclosures’’ in Application Packages and Funding Independence Avenue SW, Washington, subject line), Office: (301) 443–5204, Opportunity Announcements DC 20201. Fax: (301) 594–0899, Email: Recipients of Federal financial E. Federal Awardee Performance and [email protected]. assistance (FFA) from HHS must Integrity Information System (FAPIIS) AND administer their programs in The IHS is required to review and U.S. Department of Health and Human compliance with Federal civil rights consider any information about the Services, Office of Inspector General, law. This means that recipients of HHS applicant that is in the Federal Awardee ATTN: Mandatory Grant Disclosures, funds must ensure equal access to their Performance and Integrity Information Intake Coordinator, 330 Independence programs without regard to a person’s System (FAPIIS) before making any Avenue SW, Cohen Building, Room race, color, national origin, disability, award in excess of the simplified 5527, Washington, DC 20201, URL: age and, in some circumstances, sex and acquisition threshold (currently http://oig.hhs.gov/fraud/report-fraud/ religion. This includes ensuring your $150,000) over the period of index.asp, (Include ‘‘Mandatory Grant programs are accessible to persons with performance. An applicant may review Disclosures’’ in subject line), Fax: limited English proficiency. HHS and comment on any information about (202) 205–0604 (Include ‘‘Mandatory provides guidance to recipients of FFA itself that a Federal awarding agency Grant Disclosures’’ in subject line) or on meeting their legal obligation to take previously entered. IHS will consider Email: reasonable steps to provide meaningful any comments by the applicant, in MandatoryGranteeDisclosures@ access to their programs by persons with addition to other information in FAPIIS oig.hhs.gov. limited English proficiency. Please see in making a judgment about the Failure to make required disclosures http://www.hhs.gov/civil-rights/for- applicant’s integrity, business ethics, can result in any of the remedies individuals/special-topics/limited- and record of performance under described in 45 CFR 75.371 Remedies english-proficiency/guidance-federal- Federal awards when completing the for noncompliance, including financial-assistance-recipients-title-VI/. review of risk posed by applicants as suspension or debarment (See 2 CFR The HHS Office for Civil Rights (OCR) described in 45 CFR 75.205. parts 180 & 376 and 31 U.S.C. 3321). also provides guidance on complying As required by 45 CFR part 75 with civil rights laws enforced by HHS. Appendix XII of the Uniform Guidance, VII. Agency Contacts Please see http://www.hhs.gov/civil- non-Federal entities (NFEs) are required 1. Questions on the programmatic rights/for-individuals/section-1557/ to disclose in FAPIIS any information issues may be directed to: Roxanne

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Houston, Program Officer, Office of Tribal Resolutions Due Date: June 17, Area has an Agency Lead Negotiator Tribal Self-Governance, 5600 Fishers 2018 (ALN), designated by the IHS Director to Lane, Mail Stop: 08E05, Rockville, MD act on his or her behalf, who has I. Funding Opportunity Description 20857, Phone: (301) 443–7821, Email: authority to negotiate Self-Governance [email protected], website: Statutory Authority Compacts and Funding Agreements. http://www.ihs.gov/self-governance. The Indian Health Service (IHS) Prospective Tribes interested in 2. Questions on grants management Office of Tribal Self-Governance participating in the TSGP should and fiscal matters may be directed to: (OTSG), is accepting applications for contact their respective ALN to begin Vanietta Armstrong, Grants Planning Cooperative Agreements for the Self-Governance planning process. Management Specialist, 5600 Fishers the Tribal Self-Governance Program Also, Tribes currently participating in Lane, Mail Stop: 09E70, Rockville, MD (TSGP). This program is authorized the TSGP, who are interested in 20857, Phone: (301) 443–4792, Fax: under: Title V of the Indian Self- expanding existing or adding new (301) 594–0899, Email: Determination and Education PSFAs should also contact their [email protected]. Assistance Act (ISDEAA), 25 U.S.C. respective ALN to discuss the best 3. Questions on systems matters may 5383(e). This program is described in methods for expanding or adding new be directed to: Paul Gettys, Grant the Catalog of Federal Domestic PSFAs. Systems Coordinator, 5600 Fishers Assistance (CFDA) under 93.444. Lane, Mail Stop: 09E70, Rockville, MD Purpose 20857, Phone: (301) 443–2114; or the Background The purpose of this Planning DGM main line (301) 443–5204, Fax: The TSGP is more than an IHS Cooperative Agreement is to provide (301) 594–0899, Email: Paul.Gettys@ program; it is an expression of the resources to Tribes interested in ihs.gov. Government-to-Government entering the TSGP and to existing Self- VIII. Other Information relationship between the United States Governance Tribes interested in The Public Health Service strongly (U.S.) and Indian Tribes. Through the assuming new or expanded PSFAs. Title encourages all cooperative agreement TSGP, Tribes negotiate with the IHS to V of the ISDEAA requires a Tribe or and contract recipients to provide a assume Programs, Services, Functions, Tribal organization to complete a smoke-free workplace and promote the and Activities (PSFAs), or portions planning phase to the satisfaction of the non-use of all tobacco products. In thereof, which gives Tribes the authority Tribe. The planning phase must include addition, Public Law 103–227, the Pro- to manage and tailor health care legal and budgetary research and Children Act of 1994, prohibits smoking programs in a manner that best fits the internal Tribal government planning in certain facilities (or in some cases, needs of their communities. and organizational preparation relating any portion of the facility) in which Participation in the TSGP affords to the administration of health care regular or routine education, library, Tribes the most flexibility to tailor programs. See 25 U.S.C. 5383(d). day care, health care, or early childhood health care PSFAs and is one of three The planning phase is critical to development services are provided to ways that Tribes can choose to obtain negotiations and helps Tribes make children. This is consistent with the health care from the Federal informed decisions about which PSFAs HHS mission to protect and advance the Government for their citizens. to assume and what organizational physical and mental health of the Specifically, Tribes can choose to: (1) changes or modifications are necessary American people. Receive health care services directly to successfully support those PSFAs. A from the IHS, (2) contract with the IHS Dated: April 5, 2018. thorough planning phase improves to administer individual programs and timeliness and efficient negotiations and Michael D. Weahkee, services the IHS would otherwise ensures that the Tribe is fully prepared Assistant Surgeon General, U.S. Public Health provide (referred to as Title I Self- to assume the transfer of IHS PSFAs to Service, Acting Director, Indian Health Determination Contracting, and (3) the Tribal health program. Service. compact with the IHS to assume control [FR Doc. 2018–07941 Filed 4–16–18; 8:45 am] over health care programs the IHS A Planning Cooperative Agreement is BILLING CODE 4165–16–P would otherwise provide (referred to as not a prerequisite to enter the TSGP and Title V Self-Governance Compacting or a Tribe may use other resources to meet the TSGP). These options are not the planning requirement. Tribes that DEPARTMENT OF HEALTH AND exclusive and Tribes may choose to receive Planning Cooperative HUMAN SERVICES combine options based on their Agreements are not obligated to individual needs and circumstances. participate in the TSGP and may choose Indian Health Service The TSGP is a tribally driven to delay or decline participation based initiative, and strong Federal-Tribal on the outcome of their planning Office of Tribal Self-Governance; activities. This also applies to existing Planning Cooperative Agreement partnerships are essential to the program’s success. The IHS established Self-Governance Tribes exploring the Announcement Type: New—Limited the OTSG to implement the self- option to expand their current PSFAs or Competition governance authorities under the assume additional PSFAs. Funding Announcement Number: HHS– ISDEAA. The primary OTSG functions Limited Competition Justification 2018–IHS–TSGP–0001 are to: (1) Serve as the primary liaison Catalog of Federal Domestic Assistance Number: 93.444 and advocate for Tribes participating in There is limited competition under the TSGP, (2) develop, direct, and this announcement because the Key Dates implement TSGP policies and authorizing legislation restricts Application Deadline Date: June 17, procedures, (3) provide information and eligibility to Tribes that meet specific 2018 technical assistance to Self-Governance criteria identified in Section III. Review Date: June 25–29, 2018 Tribes, and (4) advise the IHS Director Eligibility Criteria, 1. Eligibility, A. See Earliest Anticipated Start Date: July 15, on compliance with TSGP policies, 25 U.S.C. 5383(e); 42 CFR 137.10 and 2018 regulations, and guidelines. Each IHS §§ 137.24–26.

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II. Award Information B. Grantee Cooperative Agreement Tribe’s Self-Determination Contracts or Award Activities Self-Governance Funding Agreements Type of Award (1) Research and analyze the complex with any Federal Agency. See 25 U.S.C. Cooperative Agreement. IHS budget to gain a thorough 5383; 42 CFR 137.15–23. For Tribes or Tribal organizations Estimated Funds Available understanding of funding distribution at all organizational levels and to (T/TO) that expended $750,000 or more The total amount of funding determine which PSFAs the Tribe may ($500,000 for fiscal years ending after identified for the current fiscal year (FY) elect to assume or expand. December 31, 2003) in Federal awards, 2018 is approximately $600,000. (2) Establish a process by which the OTSG shall retrieve the audits Individual award amounts are Tribes may approach the IHS to identify directly from the Federal Audit anticipated to be $120,000. The amount PSFAs and associated funding that may Clearinghouse. For T/TO that expended less than of funding available for awards issued be incorporated into their current $750,000 ($500,000 for fiscal years under this announcement are subject to programs. ending after December 31, 2003) in the availability of appropriations and (3) Determine the Tribe’s share of Federal awards, the T/TO must provide budgetary priorities of the Agency. The each Program, Service, Function and evidence of the program review IHS is under no obligation to make Activity and evaluate the current level correspondence from IHS or Bureau of awards that are selected for funding of healthcare services being provided to Indian Affairs officials. See 42 CFR under this announcement. make an informed decision on new or expanded program assumption(s). 137.21–23. Anticipated Number of Awards Meeting the eligibility criteria for a III. Eligibility Information Planning Cooperative Agreement does Approximately five awards will be 1. Eligibility not mean that a Tribe/Tribal issued under this program Organization is eligible for participation announcement. To be eligible for the New Limited in the IHS TSGP under Title V of the Competition Planning Cooperative Period of Performance ISDEAA. See 25 U.S.C. 5383; 42 CFR Agreement under this announcement, 137.15–23. For additional information The period of performance is for one an applicant must: on the eligibility for the IHS TSGP, year and will run consecutively from (A) Be an ‘‘Indian Tribe’’ as defined please visit the ‘‘Eligibility and July 15, 2018, to July 14, 2019. in 25 U.S.C. 5304(e); a ‘‘Tribal Funding’’ page on the OTSG website Organization’’ as defined in 25 U.S.C. Cooperative Agreement located at: http://www.ihs.gov/ 5304(l); or an ‘‘Inter-Tribal Consortium: SelfGovernance. As defined at 42 CFR 137.10. However, Cooperative agreements awarded by Note: Please refer to Section IV.2 the Department of Health and Human Alaska Native Villages or Alaska Native Village Corporations are not eligible if (Application and Submission Information/ Services (HHS) are administered under Subsection 2, Content and Form of the same policies as a grant. However, they are located within the area served Application Submission) for additional proof the IHS is required to have substantial by an Alaska Native regional health of applicant status documents required, such programmatic involvement in the entity. See Consolidated Appropriations as Tribal resolutions, proof of non-profit project during the entire award segment. Act, 2014, Public Law 113–76. By status, etc. Below is a detailed description of the statute, the Native Village of Eyak, 2. Cost Sharing or Matching level of involvement required for both Eastern Aleutian Tribes, and the IHS and the grantee. The IHS will be Council for Athabascan Tribal The IHS does not require matching responsible for activities listed under Governments have also been deemed funds or cost sharing for grants or section A and the grantee will be Alaska Native regional health entities cooperative agreements. and therefore are eligible to apply. responsible for activities listed under 3. Other Requirements section B as stated: Those Alaska Tribes not represented by a Self-Governance Tribal consortium If application budgets exceed the Substantial Involvement Description for Funding Agreement within their area highest dollar amount outlined under Cooperative Agreement may still be considered to participate in the ‘‘Estimated Funds Available’’ A. IHS Programmatic Involvement the TSGP. section within this funding (B) Submit Tribal resolution(s) from announcement, the application will be (1) Provide descriptions of PSFAs and the appropriate governing body of each considered ineligible and will not be associated funding at all organizational Indian Tribe to be served by the reviewed for further consideration. If levels (service unit, area, and ISDEAA Compact authorizing the deemed ineligible, IHS will not return headquarters), including funding submission of the Planning Cooperative the application. The applicant will be formulas and methodologies related to Agreement. Tribal consortia applying notified by email by the Division of determining Tribal shares. for a Planning Cooperative Agreement Grants Management (DGM) of this (2) Meet with Planning Cooperative shall submit Tribal Council resolutions decision. from each Tribe in the consortium. Agreement recipients to provide Tribal Resolution(s) program information and discuss Tribal resolutions can be attached to the Submit Tribal resolution(s) from the methods currently used to manage and electronic online application. (C) Demonstrate for three fiscal years, appropriate governing body of the deliver health care. financial stability and financial Indian Tribe to be served by the (3) Identify and provide statutes, management capability. The Indian ISDEAA Compact authorizing the regulations, and policies that provide Tribe must provide evidence that, for submission of a Negotiation Cooperative authority for administering IHS the three fiscal years prior to requesting Agreement application. Tribal consortia programs. participation in the TSGP, the Indian applying for a TSGP Negotiation (4) Provide technical assistance on the Tribe has had no uncorrected significant Cooperative Agreement shall submit IHS budget, Tribal shares, and other and material audit exceptions in the Tribal Council resolutions from each topics as needed. required annual audit of the Indian Tribe in the consortium. Tribal

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resolutions can be attached to the Æ Background information on the table of contents, budget, budget electronic online application. organization. justifications, narratives, and/or other An official signed Tribal resolution Æ Proposed scope of work, objectives, appendix items. must be received by the DGM prior to and activities that provide a description There are three parts to the narrative: a Notice of Award (NoA) being issued of what will be accomplished, including Part A—Program Information; Part B— to any applicant selected for funding. a one-page Timeframe Chart. Program Planning and Evaluation; and However, if an official signed Tribal • Tribal Resolution(s). Part C—Program Report. See below for resolution cannot be submitted with the • Letters of Support from additional details about what must be electronic application submission prior organization’s Board of Directors. included in the narrative. to the official application deadline date, • 501(c)(3) Certificate (if applicable). The page limitations below are for then a draft Tribal resolution is • Biographical sketches for all Key each narrative and budget submitted. acceptable and must be submitted by Personnel. • Contractor/Consultant resumes or Part A: Program Information (4 Page the deadline in order for the application Limit) to be considered complete and eligible qualifications and scope of work. • for review. The draft Tribal resolution is Disclosure of Lobbying Activities Section 1: Needs not in lieu of the required signed (SF–LLL). • Describe the Tribe’s current health resolution, but is acceptable until a Certification Regarding Lobbying program activities, including: How long (GG-Lobbying Form). signed resolution is received. If an • it has been operating, what programs or official signed Tribal resolution is not Copy of current Negotiated Indirect services are currently being provided, received by DGM when funding Cost rate (IDC) agreement (required in and if the applicant is currently decisions are made, then a NoA will not order to receive IDC). administering any ISDEAA Title I Self- • Organizational Chart (optional). be issued to that applicant and they will Determination Contracts or Title V Self- • Documentation of current Office of not receive any IHS funds until such Governance Compacts. Identify the need Management and Budget (OMB) time as they have submitted a signed for assistance and how the Planning Financial Audit. resolution to the Grants Management Cooperative Agreement would benefit Acceptable forms of documentation Specialist listed in this funding the health activities the Tribe is include: announcement. currently administering or looking to Æ Email confirmation from Federal An applicant submitting Tribal expand. Audit Clearinghouse (FAC) that audits resolution(s) after the initial application were submitted; or submission due date is required to Part B: Program Planning and Æ Face sheets from audit reports. ensure the information was received by Evaluation (4 Page Limit) These can be found on the FAC website: the IHS by obtaining documentation Section 1: Program Plans https://harvester.census.gov/facdissem/ confirming delivery (i.e., FedEx Main.aspx. Project Objective(s), Work Plan and tracking, postal return receipt, etc.). Approach Public Policy Requirements: IV. Application and Submission State in measureable terms the Information All Federal-wide public policies objectives and appropriate activities to apply to IHS grants and cooperative 1. Obtaining Application Materials achieve the following Planning agreements with exception of the Cooperative Agreement recipient award The application package and detailed Discrimination Policy. activities: instructions for this announcement can Requirements for Project and Budget (A) Research and analyze the complex be found at: http://www.Grants.gov or Narratives IHS budget to gain a thorough http://www.ihs.gov/dgm/funding/. understanding of funding distribution at Questions regarding the electronic A. Project Narrative: This narrative all organizational levels and determine application process may be directed to should be a separate Word document which PSFAs the Tribe may elect to Mr. Paul Gettys at (301) 443–2114 or that is not to exceed ten pages and must assume or expand. (301) 443–5204. be single-spaced, type written, have (B) Establish a process to identify consecutively numbered pages, use PSFAs and associated funding that may 2. Content and Form Application black type not smaller than 12 Submission be incorporated into current programs. characters per one inch, and be printed (C) Determine the Tribe’s share of 1 ″ The applicant must include the on one side only of standard size 8 ⁄2 each Program, Service, Function and project narrative as an attachment to the x 11″ paper. Activity and evaluate the current level application package. Mandatory Be sure to succinctly answer all of health care services being provided to documents for all applicants include: questions listed under the evaluation make an informed decision on new or • Table of contents. criteria (refer to Section V.1, Evaluation expanded program assumption. • Abstract (one page) summarizing criteria in this announcement) and place (D) Describe how the objectives are the project. all responses and required information consistent with the purpose of the • Application forms: in the correct section (noted below), or program, the needs of the people to be Æ SF–424, Application for Federal they will not be considered or scored. served, and how they will be achieved Assistance. These narratives will assist the within the proposed time frame. Æ SF–424A, Budget Information— Objective Review Committee (ORC) in Identify the expected results, benefits, Non-Construction Programs. becoming familiar with the applicant’s and outcomes or products to be derived Æ SF–424B, Assurances—Non- activities and accomplishments prior to from each objective of the project. Construction Programs. this possible cooperative agreement • Line Item Budget and Narrative award. If the narrative exceeds the page Organizational Capabilities, Key (must be single-spaced and not exceed limit, then only the first ten pages will Personnel, and Qualifications five pages). be reviewed. The ten page limit for the Describe the organizational structure • Project Narrative (must be single- narrative does not include the work of the Tribe and its ability to manage the spaced and not exceed ten pages). plan, standard forms, Tribal resolutions, proposed project. Include resumes or

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position descriptions of key staff will not be accepted for processing, nor waiver must be requested. Prior showing requisite experience and will it be given further consideration for approval must be requested and expertise. If applicable, include resumes funding. Grants.gov will notify the obtained from Mr. Robert Tarwater, and scope of work for consultants that applicant via email if the application is Director, DGM, (see Section IV.6 below demonstrate experience and expertise rejected. for additional information). A written relevant to the project. If technical challenges arise and waiver request must be sent to assistance is required with the [email protected] with a copy to Section 2: Program Evaluation electronic application process, contact [email protected]. The waiver Define the criteria to be used to Grants.gov Customer Support via email must: (1) Be documented in writing evaluate planning activities. Describe to [email protected] or at (800) 518– (emails are acceptable), before fully and clearly the methodology that 4726. Customer Support is available to submitting a paper application, and (2) will be used to determine if the needs address questions 24 hours a day, 7 days include clear justification for the need identified are being met and if the a week (except on Federal holidays). If to deviate from the required electronic outcomes are being achieved. This problems persist, contact Mr. Gettys grants submission process. section must address the following ([email protected]), DGM Grant Once the waiver request has been questions: Systems Coordinator, by telephone at approved, the applicant will receive a (A) Are the goals and objectives (301) 443–2114 or (301) 443–5204. confirmation of approval email measurable and consistent with the Please be sure to contact Mr. Gettys at containing submission instructions and purpose of the program and the needs least ten days prior to the application the mailing address to submit the of the people to be served? deadline. Please do not contact the DGM application. A copy of the written (B) Are they achievable within the until you have received a Grants.gov approval must be submitted along with proposed time frame? tracking number. In the event you are the hardcopy of the application that is Part C: Program Report (2 Page Limit) not able to obtain a tracking number, mailed to DGM. Paper applications that call the DGM as soon as possible. are submitted without a copy of the Section 1: Describe major signed waiver from the Director of the accomplishments over the last 24 4. Intergovernmental Review DGM will not be reviewed or considered months associated with the goals of this Executive Order 12372 requiring for funding. The applicant will be announcement. Please identify and intergovernmental review is not notified via email of this decision by the describe significant health related applicable to this program. Grants Management Officer of the DGM. program activities and achievements Paper applications must be received by associated with the delivery of quality 5. Funding Restrictions the DGM no later than 5:00 p.m., EDT, health services. Provide a comparison of • Pre-award costs are not allowable. on the Application Deadline Date listed the actual accomplishments to the goals • The available funds are inclusive of in the Key Dates section on page one of established for the period of direct and appropriate indirect costs. this announcement. Late applications performance, or if applicable, provide • Tribes can apply and be awarded will not be accepted for processing or justification for the lack of progress. both a Planning Cooperative Agreement considered for funding. Applicants that This section should highlight major and a Negotiation Cooperative do not adhere to the timelines for program achievements over the last 24 Agreement in the same cycle, so long as System for Award Management (SAM) months. the project proposals are different for and/or http://www.Grants.gov Section 2: Describe major activities each application. Tribes cannot apply registration or that fail to request timely over the last 24 months. Please provide for both the Planning Cooperative assistance with technical issues will not an overview of significant program Agreement and the Negotiation be considered for a waiver to submit a activities associated with the delivery of Cooperative Agreement within the same paper application. quality health services over the last 24 grant cycle with the same proposed Please be aware of the following: months. This section should address project. • significant program activities and • Only one Planning grant/ Please search for the application include those related to the cooperative agreement will be awarded package in http://www.Grants.gov by accomplishments listed in the previous per applicant per grant cycle under this entering the CFDA number or the section. announcement. Funding Opportunity Number. Both • IHS will not acknowledge receipt of numbers are located in the header of B. Budget Narrative (5 Page Limit) applications. this announcement. This narrative must include a line • If you experience technical item budget with a narrative 6. Electronic Submission Requirements challenges while submitting your justification for all expenditures All applications must be submitted application electronically, please identifying reasonable allowable, electronically. Please use the http:// contact Grants.gov support directly at: allocable costs necessary to accomplish www.Grants.gov website to submit an [email protected] or (800) 518–4726. the goals and objectives as outlined in application electronically and select the Customer Support is available to the project narrative. Budget should ‘‘Find Grant Opportunities’’ link on the address questions 24 hours a day, 7 days match the scope of work described in homepage. Follow the instructions for a week (except on Federal holidays). the project narrative. submitting an application under the • Upon contacting Grants.gov, obtain Package tab. Electronic copies of the a tracking number as proof of contact. 3. Submission Dates and Times application may not be submitted as The tracking number is helpful if there Applications must be submitted attachments to email messages are technical issues that cannot be electronically through Grants.gov by addressed to IHS employees or offices. resolved and a waiver from the agency 11:59 p.m. Eastern Daylight Time (EDT) must be obtained. on the Application Deadline Date listed Waiver Request • Applicants are strongly encouraged in the Key Dates section on page one of If the applicant needs to submit a not to wait until the deadline date to this announcement. Any application paper application instead of submitting begin the application process through received after the application deadline electronically through Grants.gov, a Grants.gov as the registration process for

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SAM and Grants.gov could take up to additional 2–5 weeks to become active). (3) Determine the Tribe’s share of fifteen working days. Completing and submitting the each Program, Service, Function and • Please use the optional attachment registration takes approximately one Activity and evaluate the current level feature in Grants.gov to attach hour to complete and SAM registration of health care services being provided to additional documentation that may be will take 3–5 business days to process. make an informed decision on new or requested by the DGM. Registration with the SAM is free of expanded program assumption. • All applicants must comply with charge. Applicants may register online (4) Describe how the objectives are any page limitation requirements at: https://www.sam.gov. consistent with the purpose of the described in this funding Additional information on program, the needs of the people to be announcement. implementing the Transparency Act, served, and how they will be achieved • After electronically submitting the including the specific requirements for within the proposed time frame. application, the applicant will receive DUNS and SAM, can be found on the Identify the expected results, benefits, an automatic acknowledgment from IHS Grants Management, Grants Policy and outcomes or products to be derived Grants.gov that contains a Grants.gov website: http://www.ihs.gov/dgm/ from each objective of the project. tracking number. The DGM will policytopics/. download the application from C. Program Evaluation (25 Points) V. Application Review Information Grants.gov and provide necessary copies Define the criteria to be used to to the appropriate agency officials. The instructions for preparing the evaluate planning activities. Clearly Neither the DGM nor the OTSG will application narrative also constitute the describe the methodologies and notify the applicant that the application evaluation criteria for reviewing and parameters that will be used to has been received. scoring the application. Weights determine if the needs identified are • Email applications will not be assigned to each section are noted in being met and if the outcomes identified accepted under this announcement. parentheses. The ten page narrative are being achieved. Are the goals and section should be written in a manner objectives measurable and consistent Dun and Bradstreet (D&B) Data that is clear to outside reviewers Universal Numbering System (DUNS) with the purpose of the program and unfamiliar with prior related activities meet the needs of the people to be All IHS applicants and grantee of the applicant. It should be well served? Are they achievable within the organizations are required to obtain a organized, succinct, and contain all proposed time frame? Describe how the DUNS number and maintain an active information necessary for reviewers to assumption of PSFAs enhances registration in the SAM database. The understand the project fully. Points will sustainable health delivery. Ensure the DUNS number is a unique 9-digit be assigned to each evaluation criteria measurement includes activities that identification number provided by D&B adding up to a total of 100 points. A will lead to sustainability. which uniquely identifies each entity. minimum score of 60 points is required The DUNS number is site specific; for funding. Points are assigned as D. Organizational Capabilities, Key therefore, each distinct performance site follows: Personnel and Qualifications (15 Points) may be assigned a DUNS number. 1. Criteria Describe the organizational structure Obtaining a DUNS number is easy, and of the Tribe and its ability to manage the there is no charge. To obtain a DUNS A. Introduction and Need for Assistance proposed project. Include resumes or number, you may access it through (25 Points) position descriptions of key staff http://fedgov.dnb.com/webform, or to Describe the Tribe’s current health showing requisite experience and expedite the process, call (866) 705– program activities, including: How long expertise. If applicable, include resumes 5711. it has been operating, what programs or and scope of work for consultants that All HHS recipients are required by the services are currently being provided, demonstrate experience and expertise Federal Funding Accountability and and if the applicant is currently relevant to the project. Transparency Act of 2006, as amended administering any ISDEAA Title I Self- E. Categorical Budget and Budget (‘‘Transparency Act’’), to report Determination Contracts or Title V Self- information on sub-awards. Governance Compacts. Identify the need Justification (10 Points) Accordingly, all IHS grantees must for assistance and how the Planning Submit a budget with a narrative notify potential first-tier sub-recipients Cooperative Agreement would benefit describing the budget request and that no entity may receive a first-tier the health activities the Tribe is matching the scope of work described in sub-award unless the entity has currently administering and/or looking the project narrative. Justify all provided its DUNS number to the prime to expand. expenditures identifying reasonable and grantee organization. This requirement allowable costs necessary to accomplish B. Project Objective(s), Work Plan and ensures the use of a universal identifier the goals and objectives as outlined in Approach (25 Points) to enhance the quality of information the project narrative. available to the public pursuant to the State in measurable terms the Transparency Act. objectives and appropriate activities to Additional Documents Can Be achieve the following Planning Uploaded as Appendix Items in System for Award Management (SAM) Cooperative Agreement recipient award Grants.gov Organizations that were not registered activities: • Work plan, logic model and/or time with Central Contractor Registration and (1) Research and analyze the complex line for proposed objectives. have not registered with SAM will need IHS budget to gain a thorough • Position descriptions for key staff. to obtain a DUNS number first and then understanding of funding distribution at • Resumes of key staff that reflect access the SAM online registration all organizational levels and determine current duties. through the SAM home page at: https:// which PSFAs the Tribe may elect to • Consultant or contractor proposed www.sam.gov (U.S. organizations will assume or expand. scope of work and letter of commitment also need to provide an Employer (2) Establish a process to identify (if applicable). Identification Number from the Internal PSFAs and associated funding that may • Current Indirect Cost Agreement. Revenue Service that may take an be incorporated into current programs. • Organizational chart.

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• Map of area identifying project approval, 60 and were deemed to be Requirements,’’ located at 45 CFR part location(s). disapproved by the ORC, will receive an 75, subpart F. • Additional documents to support Executive Summary Statement from the narrative (i.e. data tables, key news OTSG within 30 days of the conclusion 3. Indirect Costs articles, etc.). of the ORC outlining the strengths and This section applies to all grant weaknesses of their application. The 2. Review and Selection recipients that request reimbursement of summary statement will be sent to the indirect costs (IDC) in their grant Each application will be prescreened Authorized Organizational application. In accordance with HHS by the DGM staff for eligibility and Representative that is identified on the Grants Policy Statement, Part II–27, IHS completeness as outlined in the funding face page (SF–424) of the application. requires applicants to obtain a current announcement. Applications that meet The OTSG will also provide additional IDC rate agreement prior to award. The the eligibility criteria shall be reviewed contact information as needed to rate agreement must be prepared in for merit by the ORC based on address questions and concerns as well accordance with the applicable cost evaluation criteria in this funding as provide technical assistance if principles and guidance as provided by announcement. The ORC could be desired. the cognizant agency or office. A current composed of both Tribal and Federal Approved But Unfunded Applicants rate covers the applicable grant reviewers appointed by the IHS Program activities under the current award’s to review and make recommendations Approved but unfunded applicants budget period. If the current rate is not on these applications. The technical that met the minimum scoring range on file with the DGM at the time of review process ensures selection of and were deemed by the ORC to be award, the IDC portion of the budget quality projects in a national ‘‘Approved,’’ but were not funded due will be restricted. The restrictions competition for limited funding. to lack of funding, will have their remain in place until the current rate is Incomplete applications and applications held by DGM for a period provided to the DGM. applications that are non-responsive to of one year. If additional funding the eligibility criteria will not be becomes available during the course of Generally, IDC rates for IHS grantees referred to the ORC. The applicant will FY 2018 the approved but unfunded are negotiated with the Division of Cost be notified via email of this decision by application may be re-considered by the Allocation (DCA) https://rates.psc.gov/ the Grants Management Officer of the OTSG for possible funding. The and the Department of Interior (Interior DGM. Applicants will be notified by applicant will also receive an Executive Business Center) https://www.doi.gov/ DGM, via email, to outline minor Summary Statement from the OTSG ibc/services/finance/indirect-Cost- missing components (i.e., budget within 30 days of the conclusion of the Services/indian-tribes. For questions narratives, audit documentation, key ORC. regarding the indirect cost policy, please call the Grants Management Specialist contact form) needed for an otherwise Note: Any correspondence other than the complete application. All missing listed under ‘‘Agency Contacts’’ or the official NoA signed by an IHS grants main DGM office at (301) 443–5204. documents must be sent to DGM on or management official announcing to the before the due date listed in the email project director that an award has been made 4. Reporting Requirements of notification of missing documents to their organization is not an authorization required. to implement their program on behalf of the The grantee must submit required To obtain a minimum score for IHS. reports consistent with the applicable funding by the ORC, applicants must deadlines. Failure to submit required address all program requirements and 2. Administrative Requirements reports within the time allowed may provide all required documentation. Cooperative agreements are result in suspension or termination of an active grant, withholding of VI. Award Administration Information administered in accordance with the following regulations and policies: additional awards for the project, or 1. Award Notices A. The criteria as outlined in this other enforcement actions such as The NoA is a legally binding program announcement. withholding of payments or converting document signed by the Grants B. Administrative Regulations for to the reimbursement method of Management Officer and serves as the Grants: payment. Continued failure to submit • official notification of the grant award. Uniform Administrative required reports may result in one or The NoA will be initiated by the DGM Requirements for HHS Awards, located both of the following: (1) The in our grant system, GrantSolutions at 45 CFR part 75, located on the U.S. imposition of special award provisions, (https://www.grantsolutions.gov). Each Government Publishing Office website and (2) the non-funding or non-award of entity that is approved for funding at: http://www.ecfr.gov/cgi-bin/text- other eligible projects or activities. This under this announcement will need to idx?node=pt45.1.75. requirement applies whether the request or have a user account in C. Grants Policy: delinquency is attributable to the failure GrantSolutions in order to retrieve their • HHS Grants Policy Statement, of the grantee organization or the NoA. The NoA is the authorizing Revised 01/07 located at: http:// individual responsible for preparation document for which funds are dispersed www.hhs.gov/sites/default/files/grants/ of the reports. Per DGM policy, all to the approved entities and reflects the grants/policies-regulations/ reports are required to be submitted amount of Federal funds awarded, the hhsgps107.pdf. electronically by attaching them as a purpose of the grant, the terms and D. Cost Principles: ‘‘Grant Note’’ in GrantSolutions. conditions of the award, the effective • Uniform Administrative Personnel responsible for submitting date of the award, and the budget/ Requirements for HHS Awards, ‘‘Cost reports will be required to obtain a login period of performance. Principles,’’ located at 45 CFR part 75, and password for GrantSolutions. Please subpart E. see the Agency Contacts list in section Disapproved Applicants E. Audit Requirements: VII for the systems contact information. Applicants who received a score less • Uniform Administrative The reporting requirements for this than the recommended funding level for Requirements for HHS Awards, ‘‘Audit program are noted below.

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A. Progress Reports will be required to address the FSRS his/her exclusion from benefits limited Program progress reports are required reporting. by Federal law to individuals eligible For the full IHS award term semi-annually. These reports must for benefits and services from the IHS. implementing this requirement and Recipients will be required to sign the include a brief comparison of actual additional award applicability HHS–690 Assurance of Compliance accomplishments to the goals information, visit the DGM Grants form which can be obtained from the established for the six month period, a Policy website at: http://www.ihs.gov/ following website: http://www.hhs.gov/ summary of progress to date or, if dgm/policytopics/. sites/default/files/forms/hhs-690.pdf, applicable, provide sound justification and send it directly to the: U.S. D. Compliance With Executive Order for the lack of progress, and other Department of Health and Human 13166 Implementation of Services pertinent information as required by the Services, Office of Civil Rights, 200 Accessibility Provisions for All Grant program office. A final report must be Independence Avenue SW, Washington, Application Packages and Funding submitted within 90 days of expiration DC 20201. of the budget or period of performance. Opportunity Announcements E. Federal Awardee Performance and B. Financial Reports Recipients of Federal financial assistance (FFA) from HHS must Integrity Information System (FAPIIS) Federal Financial Report (FFR or SF– administer their programs in The IHS is required to review and 425), Cash Transaction Reports are due compliance with Federal civil rights consider any information about the 30 days after the close of every calendar law. This means that recipients of HHS applicant that is in the Federal Awardee quarter to the Payment Management funds must ensure equal access to their Performance and Integrity Information Services, HHS at: https://pms.psc.gov. It programs without regard to a person’s System (FAPIIS) before making any is recommended that the applicant also race, color, national origin, disability, award in excess of the simplified send a copy of the FFR (SF–425) report age and, in some circumstances, sex and acquisition threshold (currently to the Grants Management Specialist. religion. This includes ensuring your $150,000) over the period of Failure to submit timely reports may programs are accessible to persons with performance. An applicant may review cause a disruption in timely payments limited English proficiency. HHS and comment on any information about to the organization. provides guidance to recipients of FFA itself that a Federal awarding agency Grantees are responsible and on meeting their legal obligation to take previously entered. IHS will consider accountable for accurate information reasonable steps to provide meaningful any comments by the applicant, in being reported on all required reports: access to their programs by persons with addition to other information in FAPIIS The Progress Reports and Federal limited English proficiency. Please see in making a judgment about the Financial Report. http://www.hhs.gov/civil-rights/for- applicant’s integrity, business ethics, C. Federal Sub-Award Reporting System individuals/special-topics/limited- and record of performance under (FSRS) english-proficiency/guidance-federal- Federal awards when completing the financial-assistance-recipients-title-VI/. review of risk posed by applicants as This award may be subject to the The HHS Office for Civil Rights (OCR) described in 45 CFR 75.205. Transparency Act sub-award and also provides guidance on complying As required by 45 CFR part 75 executive compensation reporting with civil rights laws enforced by HHS. Appendix XII of the Uniform Guidance, requirements of 2 CFR part 170. Please see http://www.hhs.gov/civil- non-Federal entities (NFEs) are required The Transparency Act requires the rights/for-individuals/section-1557/ to disclose in FAPIIS any information OMB to establish a single searchable index.html; and http://www.hhs.gov/ about criminal, civil, and administrative database, accessible to the public, with civil-rights/index.html. Recipients of proceedings, and/or affirm that there is information on financial assistance FFA also have specific legal obligations no new information to provide. This awards made by Federal agencies. The for serving qualified individuals with applies to NFEs that receive Federal Transparency Act also includes a disabilities. Please see http:// awards (currently active grants, requirement for recipients of Federal www.hhs.gov/civil-rights/for- cooperative agreements, and grants to report information about first- individuals/disability/index.html. procurement contracts) greater than tier sub-awards and executive Please contact the HHS OCR for more $10,000,000 for any period of time compensation under Federal assistance information about obligations and during the period of performance of an awards. prohibitions under Federal civil rights award/project. IHS has implemented a Term of laws at: https://www.hhs.gov/ocr/about- Award into all IHS Standard Terms and us/contact-us/index.html or call (800) Mandatory Disclosure Requirements Conditions, NoAs and funding 368–1019 or TDD (800) 537–7697. Also As required by 2 CFR part 200 of the announcements regarding the FSRS note it is an HHS Departmental goal to Uniform Guidance, and the HHS reporting requirement. This IHS Term of ensure access to quality, culturally implementing regulations at 45 CFR part Award is applicable to all IHS grant and competent care, including long-term 75, effective January 1, 2016, the IHS cooperative agreements issued on or services and supports, for vulnerable must require a non-Federal entity or an after October 1, 2010, with a $25,000 populations. For further guidance on applicant for a Federal award to sub-award obligation dollar threshold providing culturally and linguistically disclose, in a timely manner, in writing met for any specific reporting period. appropriate services, recipients should to the IHS or pass-through entity all Additionally, all new (discretionary) review the National Standards for violations of Federal criminal law IHS awards (where the period of Culturally and Linguistically involving fraud, bribery, or gratuity performance is made up of more than Appropriate Services in Health and violations potentially affecting the one budget period) and where: (1) The Health Care at: https:// Federal award. period of performance start date was minorityhealth.hhs.gov/omh/ Submission is required for all October 1, 2010, or after, and (2) the browse.aspx?lvl=2&lvlid=53. applicants and recipients, in writing, to primary awardee will have a $25,000 Pursuant to 45 CFR 80.3(d), an the IHS and to the HHS Office of sub-award obligation dollar threshold individual shall not be deemed Inspector General all information during any specific reporting period subjected to discrimination by reason of related to violations of Federal criminal

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law involving fraud, bribery, or gratuity Children Act of 1994, prohibits smoking Place: Bethesda North Marriott Hotel & violations potentially affecting the in certain facilities (or in some cases, Conference Center, 5701 Marinelli Road, Federal award. 45 CFR 75.113. any portion of the facility) in which Bethesda, MD 20852. Disclosures must be sent in writing to: regular or routine education, library, Contact Person: Susana Mendez, DVM, Ph.D., Scientific Review Officer, Scientific U.S. Department of Health and Human day care, health care, or early childhood Review Program, Division of Extramural Services, Indian Health Service, development services are provided to Activities, Room 3G53B, National Institutes Division of Grants Management, children. This is consistent with the of Health, NIAID, 5601 Fishers Lane Dr., ATTN: Robert Tarwater, Director, HHS mission to protect and advance the MSC 9823, Bethesda, MD 20892–9823, (240) 5600 Fishers Lane, Mail Stop: 09E70, physical and mental health of the 669–5077, [email protected]. Rockville, MD 20857. (Include American people. Name of Committee: National Institute of ‘‘Mandatory Grant Disclosures’’ in Dated: April 5, 2018. Allergy and Infectious Diseases Special subject line). Office: (301) 443–5204, Emphasis Panel; NIAID Peer Review Meeting. Michael D. Weahkee, Fax: (301) 594–0899, Email: Date: May 10, 2018. [email protected] Assistant Surgeon General, U.S. Public Health Time: 8:00 a.m. to 12:30 p.m. Service, Acting Director, Indian Health Agenda: To review and evaluate contract AND Service. proposals. U.S. Department of Health and Human [FR Doc. 2018–07942 Filed 4–16–18; 8:45 am] Place: Bethesda North Marriott Hotel & Conference Center, 5701 Marinelli Road, Services, Office of Inspector General, BILLING CODE 4165–16–P Bethesda, MD 20852. ATTN: Mandatory Grant Disclosures, Contact Person: Annie Walker-Abbey, Intake Coordinator, 330 Independence DEPARTMENT OF HEALTH AND Ph.D., Scientific Review Officer, Scientific Avenue SW, Cohen Building, Room Review Program, NIAID/NIH/DHHS, 5601 5527, Washington, DC 20201, URL: HUMAN SERVICES Fishers Lane, Room 3E70A, Rockville, MD http://oig.hhs.gov/fraud/report-fraud/ 20852, 240–627–3390, [email protected]. National Institutes of Health index.asp. (Include ‘‘Mandatory Grant (Catalogue of Federal Domestic Assistance Disclosures’’ in subject line). Fax: National Institute of Allergy and Program Nos. 93.855, Allergy, Immunology, (202) 205–0604 (Include ‘‘Mandatory and Transplantation Research; 93.856, Infectious Diseases; Notice of Closed Grant Disclosures’’ in subject line) or Microbiology and Infectious Diseases Meetings Email: MandatoryGrantee Research, National Institutes of Health, HHS) [email protected] Pursuant to section 10(d) of the Dated: April 11, 2018. Failure to make required disclosures Federal Advisory Committee Act, as Natasha M. Copeland, can result in any of the remedies amended, notice is hereby given of the Program Analyst, Office of Federal Advisory described in 45 CFR 75.371 Remedies following meetings. Committee Policy. for noncompliance, including The meetings will be closed to the [FR Doc. 2018–07915 Filed 4–16–18; 8:45 am] suspension or debarment (See 2 CFR BILLING CODE 4140–01–P parts 180 & 376 and 31 U.S.C. 3321). public in accordance with the provisions set forth in sections VII. Agency Contacts 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., DEPARTMENT OF HEALTH AND 1. Questions on the programmatic as amended. The contract proposals and HUMAN SERVICES issues may be directed to: Roxanne the discussions could disclose Houston, Program Officer, Office of confidential trade secrets or commercial National Institutes of Health Tribal Self-Governance, 5600 Fishers property such as patentable material, Lane, Mail Stop: 08E05, Rockville, MD and personal information concerning National Institute of Allergy and 20857, Phone: (301) 443–7821, Email: individuals associated with the contract Infectious Diseases Notice of Closed [email protected], Website: proposals, the disclosure of which Meetings http://www.ihs.gov/self-governance. would constitute a clearly unwarranted 2. Questions on grants management invasion of personal privacy. Pursuant to section 10(d) of the Federal Advisory Committee Act, as and fiscal matters may be directed to: Name of Committee: National Institute of Vanietta Armstrong, Grants Allergy and Infectious Diseases Special amended, notice is hereby given of the Management Specialist, 5600 Fishers Emphasis Panel; NIAID Peer Review Meeting. following meetings. Lane, Mail Stop: 09E70, Rockville, MD Date: May 9, 2018. The meetings will be closed to the 20857, Phone: (301) 443–4792, Fax: Time: 8:00 a.m. to 12:00 p.m. public in accordance with the 301–594–0899, Email: Agenda: To review and evaluate contract provisions set forth in sections [email protected]. proposals. 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., 3. Questions on systems matters may Place: Bethesda North Marriott Hotel & as amended. The grant applications and be directed to: Paul Gettys, Grant Conference Center, 5701 Marinelli Road, the discussions could disclose Systems Coordinator, 5600 Fishers Bethesda, MD 20852. confidential trade secrets or commercial Contact Person: Susana Mendez, DVM, Lane, Mail Stop: 09E70, Rockville, MD property such as patentable material, 20857, Phone: (301) 443–2114; or the Ph.D., Scientific Review Officer, Scientific Review Program, Division of Extramural and personal information concerning DGM main line (301) 443–5204, Fax: Activities, Room 3G53B, National Institutes individuals associated with the grant (301) 594–0899, E-Mail: Paul.Gettys@ of Health, NIAID, 5601 Fishers Lane Dr., applications, the disclosure of which ihs.gov. MSC 9823, Bethesda, MD 20892–9823, (240) would constitute a clearly unwarranted VIII. Other Information 669–5077, [email protected]. invasion of personal privacy. Name of Committee: National Institute of The Public Health Service strongly Name of Committee: National Institute of Allergy and Infectious Diseases Special Allergy and Infectious Diseases Special encourages all cooperative agreement Emphasis Panel; NIAID Peer Review Meeting. Emphasis Panel; NIAID Peer Review Meeting. and contract recipients to provide a Date: May 9, 2018. Date: May 8, 2018. smoke-free workplace and promote the Time: 1:00 p.m. to 5:00 p.m. Time: 8:00 a.m. to 5:30 p.m. non-use of all tobacco products. In Agenda: To review and evaluate contract Agenda: To review and evaluate contract addition, Public Law 103–227, the Pro- proposals. proposals.

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Place: Bethesda North Marriott Hotel & would constitute a clearly unwarranted Craniofacial Research, including Conference Center, 5701 Marinelli Road, invasion of personal privacy. consideration of personnel Bethesda, MD 20852. Name of Committee: National Advisory qualifications and performance, and the Contact Person: Annie Walker-Abbey, competence of individual investigators, Ph.D., Scientific Review Officer, Scientific Dental and Craniofacial Research Council. Review Program, NIAID/NIH/DHHS, 5601 Date: May 25, 2018. the disclosure of which would Fishers Lane, Room 3E70A, Rockville, MD Open: 8:30 a.m. to 12:20 p.m. constitute a clearly unwarranted 20852, 240–627–3390, [email protected]. Agenda: Report to the Director, NIDCR. invasion of personal privacy. Place: National Institutes of Health, Name of Committee: National Institute of Building 31, 6th Floor, Conference Room 10, Name of Committee: Board of Scientific Allergy and Infectious Diseases Special 31 Center Drive, Bethesda, MD 20892. Counselors, National Institute of Dental and Emphasis Panel; AIDSRRC Independent SEP. Closed: 1:30 p.m. to 2:30 p.m. Craniofacial Research. Date: May 8, 2018. Agenda: To review and evaluate grant Date: May 8–10, 2018. Time: 1:00 p.m. to 5:00 p.m. applications. Time: May 8, 2018, 7:00 p.m. to 8:00 p.m. Agenda: To review and evaluate grant Place: National Institutes of Health, Agenda: To review and evaluate personal applications. Building 31, 6th Floor, Conference Room 10, qualifications and performance, and Place: National Institutes of Health, 5601 31 Center Drive, Bethesda, MD 20892. competence of individual investigators. Fishers Lane, Rockville, MD 20892 Contact Person: Alicia J. Dombroski, Ph.D., Place: Doubletree Hotel Bethesda (Telephone Conference Call). Director, Division of Extramural Activities, (Formerly Holiday Inn Select), 8120 Contact Person: Audrey O. Lau, Ph.D., National Institute of Dental and Craniofacial Wisconsin Avenue, Bethesda, MD 20814. MPH, Scientific Review Officer, AIDS Research, National Institutes of Health, Time: May 9, 2018, 8:00 a.m. to 6:00 p.m. Review Branch, SRP, RM 3E70, National Bethesda, MD 20892, 301–594–4805, Agenda: To review and evaluate personal Institutes of Health, NIAID, 5601 Fishers [email protected]. qualifications and performance, and Lane, MSC 9834, Rockville, MD 20852–9834, competence of individual investigators. In the interest of security, NIH has 240–669–2081, [email protected]. Place: National Institutes of Health, instituted stringent procedures for entrance Building 30, Room 117, 30 Center Drive, (Catalogue of Federal Domestic Assistance onto the NIH campus. All visitor vehicles, Bethesda, MD 20892. Program Nos. 93.855, Allergy, Immunology, including taxicabs, hotel, and airport shuttles Time: May 10, 2018, 8:00 a.m. to 4:15 p.m. and Transplantation Research; 93.856, will be inspected before being allowed on Agenda: To review and evaluate personal Microbiology and Infectious Diseases campus. Visitors will be asked to show one qualifications and performance, and Research, National Institutes of Health, HHS) form of identification (for example, a competence of individual investigators. government-issued photo ID, driver’s license, Dated: April 11, 2018. Place: National Institutes of Health, or passport) and to state the purpose of their Natasha M. Copeland, Building 30, Room 117, 30 Center Drive, visit. Bethesda, MD 20892. Program Analyst, Office of Federal Advisory Information is also available on the Contact Person: Alicia J. Dombroski, Ph.D., Committee Policy. Institute’s/Center’s home page: http:// Director, Division of Extramural Activities, [FR Doc. 2018–07914 Filed 4–16–18; 8:45 am] www.nidcr.nih.gov/about, where an agenda National Institute of Dental and Craniofacial BILLING CODE 4140–01–P and any additional information for the Research, National Institutes of Health, meeting will be posted when available. Bethesda, MD 20892. (Catalogue of Federal Domestic Assistance Information is also available on the DEPARTMENT OF HEALTH AND Program Nos. 93.121, Oral Diseases and Institute’s/Center’s home page: http:// Disorders Research, National Institutes of HUMAN SERVICES www.nidcr.nih.gov/about/ Health, HHS) CouncilCommittees.asp, where an agenda National Institutes of Health Dated: April 11, 2018. and any additional information for the Natasha M. Copeland, meeting will be posted when available. National Institute of Dental and (Catalogue of Federal Domestic Assistance Craniofacial Research; Notice of Program Analyst, Office of Federal Advisory Committee Policy. Program Nos. 93.121, Oral Diseases and Meeting Disorders Research, National Institutes of [FR Doc. 2018–07917 Filed 4–16–18; 8:45 am] Health, HHS) Pursuant to section 10(d) of the BILLING CODE 4140–01–P Federal Advisory Committee Act, as Dated: April 11, 2018. amended, notice is hereby given of a Natasha M. Copeland, meeting of the National Advisory Dental DEPARTMENT OF HEALTH AND Program Analyst, Office of Federal Advisory and Craniofacial Research Council. HUMAN SERVICES Committee Policy. The meeting will be open to the [FR Doc. 2018–07916 Filed 4–16–18; 8:45 am] National Institutes of Health public as indicated below, with BILLING CODE 4140–01–P attendance limited to space available. National Institute of Dental and Individuals who plan to attend and Craniofacial Research; Notice of need special assistance, such as sign DEPARTMENT OF HEALTH AND Closed Meeting language interpretation or other HUMAN SERVICES reasonable accommodations, should Pursuant to section 10(d) of the notify the Contact Person listed below Federal Advisory Committee Act, as National Institutes of Health in advance of the meeting. amended, notice is hereby given of a Office of the Secretary; Notice of The meeting will be closed to the meeting of the Board of Scientific Meetings public in accordance with the Counselors, National Institute of Dental provisions set forth in sections and Craniofacial Research. Pursuant to section 10(a) of the 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., The meeting will be closed to the Federal Advisory Committee Act, as as amended. The grant applications and public as indicated below in accordance amended, notice is hereby given of the discussions could disclose with the provisions set forth in section meetings of the Task Force on Research confidential trade secrets or commercial 552b(c)(6), Title 5 U.S.C., as amended Specific to Pregnant Women and property such as patentable material, for the review, discussion, and Lactating Women. and personal information concerning evaluation of individual intramural The meetings will be open to the individuals associated with the grant programs and projects conducted by the public, with attendance limited to space applications, the disclosure of which National Institute of Dental and available. Individuals who plan to

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attend and need special assistance, such three to five minutes per speaker depending commercial gauger and laboratory as sign language interpretation or other on the number of speakers to be became effective on July 6, 2017. The reasonable accommodations, should accommodated within the allotted time. next triennial inspection date will be Speakers will be assigned a time to speak in notify the Contact Person listed below the order of the date and time when their scheduled for July 2020. in advance of the meeting. request to speak is received. Both printed and FOR FURTHER INFORMATION CONTACT: Mr. Name of Committee: Task Force on electronic copies are requested for the record. Stephen Cassata, Laboratories and Research Specific to Pregnant Women and Details and additional information about these meetings can be found at the NICHD Scientific Services Directorate, U.S. Lactating Women. Customs and Border Protection, 1300 Date: May 14–15, 2018. website for the Task Force on Research Time: May 14, 2018 8:30 a.m. to 5:00 p.m., Specific to Pregnant Women and Lactating Pennsylvania Avenue NW, Suite 1500N, May 15, 2018 8:00 a.m. to 2:30 p.m. Women (PRGLAC) https:// Washington, DC 20229, tel. 202–344– Agenda: The Task Force is charged with www.nichd.nih.gov/about/advisory/PRGLAC/ 1060. providing advice and guidance to the Pages/index.aspx. Secretary of HHS, regarding Federal activities Dated: April 11, 2018. SUPPLEMENTARY INFORMATION: Notice is hereby given pursuant to 19 CFR 151.12 related to identifying and addressing gaps in Michelle D. Trout, knowledge and research regarding safe and and 19 CFR 151.13, that Camin Cargo effective therapies for pregnant women and Analyst, Office of Federal Advisory Committee Policy. Control, Inc., 1301 Metropolitan Ave., lactating women, including the development Thorofare, NJ 08086, has been approved of such therapies and the collaboration on [FR Doc. 2018–07918 Filed 4–16–18; 8:45 am] to gauge and accredited to test and coordination of such activities. BILLING CODE 4140–01–P Place: 6710B Rockledge Drive, Room 1425/ petroleum and certain petroleum 1427 (1st Floor), Bethesda, MD 20817. products for customs purposes, in Contact Person: Ms. Lisa Kaeser, Executive accordance with the provisions of 19 Secretary, Eunice Kennedy Shriver National DEPARTMENT OF HOMELAND CFR 151.12 and 19 CFR 151.13. Camin Institute of Child Health and Human SECURITY Cargo Control, Inc., is approved for the Development, 31 Center Drive, Room 2A03, Customs and Border Protection following gauging procedures for MSC 2425, Bethesda, MD 20892, (301) 496– petroleum and certain petroleum 0536, [email protected]. products set forth by the American Public comments are welcome either by Accreditation and Approval of Camin filing written comments and/or providing Cargo Control, Inc., as a Commercial Petroleum Institute (API): oral comments at the meeting. Oral Gauger and Laboratory comments from the public will be scheduled API chapters Title AGENCY on May 14, 2018, from approximately 10:00 : U.S. Customs and Border a.m.–10:45 a.m. Any member of the public Protection, Department of Homeland 3 ...... Tank Gauging. interested in presenting oral comments on Security. 7 ...... Temperature Determination. 8 ...... Sampling. May 14, 2018, should submit a letter of ACTION: Notice of accreditation and 11 ...... Physical Property. intent, a brief description of the organization approval of Camin Cargo Control, Inc., 12 ...... Calculations. represented, and the oral presentation to Ms. as a commercial gauger and laboratory. Lisa Kaeser ([email protected]) by 5:00 17 ...... Maritime Measurements. p.m. on Monday, May 7, 2018. Written SUMMARY: Notice is hereby given, comments to be included at the meeting pursuant to CBP regulations, that Camin Camin Cargo Control, Inc., is should also be sent to Lisa Kaeser by 5:00 Cargo Control, Inc., has been approved accredited for the following laboratory p.m. on Monday, May 7, 2018. to gauge and accredited to test analysis procedures and methods for The submitted presentations and any petroleum and certain petroleum petroleum and certain petroleum written comments will be formatted to be posted on the PRGLAC website for the products for customs purposes for the products set forth by the U.S. Customs record. Only one representative of an next three years as of July 6, 2017. and Border Protection Laboratory organization may be allowed to present oral DATES: The accreditation and approval Methods (CBPL) and American Society comments. Presentations will be limited to of Camin Cargo Control, Inc., as for Testing and Materials (ASTM):

CBPL No. Method Title

27–08 ...... ASTM D86 Standard Test Method for Distillation of Petroleum Products. 27–48 ...... ASTM D4052 Standard Test Method for Density and Relative Density of Liquids by Digital Density Meter. 27–58 ...... ASTM D5191 Standard Test Method For Vapor Pressure of Petroleum Products (Mini Method).

Anyone wishing to employ this entity website listed below for the current CBP DEPARTMENT OF HOMELAND to conduct laboratory analyses and Approved Gaugers and Accredited SECURITY gauger services should request and Laboratories List. http://www.cbp.gov/ receive written assurances from the about/labs-scientific/commercial- Customs and Border Protection entity that it is accredited or approved gaugers-and-laboratories. Approval of Intertek USA, Inc., as a by the U.S. Customs and Border Dated: April 10, 2018. Commercial Gauger Protection to conduct the specific test or James D. Sweet, gauger service requested. Alternatively, AGENCY: U.S. Customs and Border inquiries regarding the specific test or Acting Executive Director, Laboratories and Scientific Services Directorate. Protection, Department of Homeland gauger service this entity is accredited Security. or approved to perform may be directed [FR Doc. 2018–07969 Filed 4–16–18; 8:45 am] BILLING CODE 9111–14–P ACTION: Notice of approval of Intertek to the U.S. Customs and Border USA, Inc., as a commercial gauger. Protection by calling (202) 344–1060. The inquiry may also be sent to SUMMARY: Notice is hereby given, [email protected]. Please reference the pursuant to CBP regulations, that

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Intertek USA, Inc., has been approved to DEPARTMENT OF HOMELAND Federal agencies to comment on the gauge petroleum and certain petroleum SECURITY proposed and/or continuing information products for customs purposes for the collections pursuant to the Paperwork next three years as of September 20, U.S. Customs and Border Protection Reduction Act of 1995 (44 U.S.C. 3501 2017. [1651–0024] et seq.). This process is conducted in accordance with 5 CFR 1320.8. Written DATES: The approval of Intertek USA, Agency Information Collection comments and suggestions from the Inc., as commercial gauger became Activities: Entry/Immediate Delivery public and affected agencies should effective on September 20, 2017. The Application and ACE Cargo Release address one or more of the following next triennial inspection date will be four points: (1) Whether the proposed scheduled for September 2020. AGENCY: U.S. Customs and Border collection of information is necessary Protection (CBP), Department of for the proper performance of the FOR FURTHER INFORMATION CONTACT: Mr. Homeland Security. Stephen Cassata, Laboratories and functions of the agency, including ACTION: 60-Day Notice and request for Scientific Services, U.S. Customs and whether the information will have comments; revision and extension of an practical utility; (2) the accuracy of the Border Protection, 1300 Pennsylvania existing collection of information. Avenue NW, Suite 1500N, Washington, agency’s estimate of the burden of the DC 20229, tel. 202–344–1060. SUMMARY: The Department of Homeland proposed collection of information, Security, U.S. Customs and Border including the validity of the SUPPLEMENTARY INFORMATION: Notice is Protection will be submitting the methodology and assumptions used; (3) hereby given pursuant to 19 CFR 151.13, following information collection request suggestions to enhance the quality, that Intertek USA, Inc., 1020 South to the Office of Management and Budget utility, and clarity of the information to Holland Sylvania Rd., Holland, OH (OMB) for review and approval in be collected; and (4) suggestions to 43528, has been approved to gauge accordance with the Paperwork minimize the burden of the collection of petroleum and certain petroleum Reduction Act of 1995 (PRA). The information on those who are to products for customs purposes, in information collection is published in respond, including through the use of accordance with the provisions of 19 the Federal Register to obtain comments appropriate automated, electronic, CFR 151.13. Intertek USA, Inc., is from the public and affected agencies. mechanical, or other technological approved for the following gauging Comments are encouraged and will be collection techniques or other forms of procedures for petroleum and certain accepted (no later than June 18, 2018) to information technology, e.g., permitting petroleum products set forth by the be assured of consideration. electronic submission of responses. The American Petroleum Institute (API): ADDRESSES: Written comments and/or comments that are submitted will be suggestions regarding the item(s) summarized and included in the request API for approval. All comments will become chapters Title contained in this notice must include the OMB Control Number 1651–0024 in a matter of public record. 2 ...... Tank Calibration. the subject line and the agency name. Overview of This Information 3 ...... Tank gauging. To avoid duplicate submissions, please Collection 7 ...... Temperature Determination. use only one of the following methods 8 ...... Sampling. to submit comments: Title: Entry/Immediate Delivery 12 ...... Calculations. (1) Email. Submit comments to: CBP_ Application and ACE Cargo Release. 14 ...... Natural Gas Fluids Measure- [email protected]. OMB Number: 1651–0024. ments. (2) Mail. Submit written comments to Form Number: 3461 and 3461 ALT. 17 ...... Maritime Measurements. CBP Paperwork Reduction Act Officer, Current Actions: This submission is U.S. Customs and Border Protection, being made to extend the expiration Anyone wishing to employ this entity Office of Trade, Regulations and date with a change in the data collected. to conduct gauger services should Rulings, Economic Impact Analysis There is an increase to the annual request and receive written assurances Branch, 90 K Street NE, 10th Floor, burden hours based on updated agency from the entity that it is approved by the Washington, DC 20229–1177. estimates. Since the last OMB Renewal U.S. Customs and Border Protection to FOR FURTHER INFORMATION CONTACT: there have been two submissions for a conduct the specific gauger service Requests for additional PRA information Non Substantive Change for this requested. Alternatively, inquiries should be directed to Seth Renkema, information collection. The Non regarding the specific gauger service this Chief, Economic Impact Analysis Substantive Changes made are the entity is approved to perform may be Branch, U.S. Customs and Border following: directed to the U.S. Customs and Border Protection, Office of Trade, Regulations Change one submitted on February Protection by calling (202) 344–1060. and Rulings, 90 K Street NE, 10th Floor, 22, 2018: CBP is submitting this Non The inquiry may also be sent to Washington, DC 20229–1177, Substantive Change to OMB to reflect a [email protected]. Please reference the Telephone number (202) 325–0056 or change in the Harmonized Tariff _ website listed below for a complete via email CBP [email protected]. Please Schedule (HTS) which is maintained by listing of CBP approved gaugers and note that the contact information the U.S. International Trade accredited laboratories. http:// provided here is solely for questions Commission (USITC). HTS data is www.cbp.gov/about/labs-scientific/ regarding this notice. Individuals provided to CBP at entry. commercial-gaugers-and-laboratories. seeking information about other CBP Effective February 7, 2018, the programs should contact the CBP following changes to the Harmonized Dated: April 10, 2018. National Customer Service Center at Tariff Schedule for units of quantity James D. Sweet, 877–227–5511, (TTY) 1–800–877–8339, reporting will take effect: Acting Executive Director, Laboratories and or CBP website at https://www.cbp. • For HTS 8450.90.20 and Scientific Services Directorate. gov/. 8450.90.60, certain parts of washing [FR Doc. 2018–07975 Filed 4–16–18; 8:45 am] SUPPLEMENTARY INFORMATION: CBP machines, the new unit of quantity will BILLING CODE 9111–14–P invites the general public and other be ‘‘No.’’ instead of ‘‘X’’.

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• For HTS 8541.40.6030, solar cells, a 3461 are accessible at: http:// DEPARTMENT OF HOUSING AND second unit of quantity, ‘‘W’’ (for total www.cbp.gov/newsroom/publications/ URBAN DEVELOPMENT wattage), will be added. forms • [Docket No. FR–7001–N–10] For statistical reporting purposes ACE Cargo Release is a program for under subheading 8541.40.6030, ACE entry summary filers in which 30-Day Notice of Proposed Information importers should report the total watts importers or brokers may file Simplified Collection: Mortgagor’s Certificate of at maximum power based on standard Entry data in lieu of filing the CBP Form Actual Cost test conditions according to the latest 3461. This data consists of 12 required revision of International elements: Importer of record; buyer AGENCY: Office of the Chief Information Electrotechnical Commission (IEC) name and address; buyer employer Officer, HUD. 60904, ‘‘Photovoltaic Devices.’’ ACTION: Notice. • identification number (consignee These modifications will take effect number), seller name and address; SUMMARY: as announced in Presidential manufacturer/supplier name and HUD submitted the proposed Proclamations 9693 (83 FR 3541) and address; Harmonized Tariff Schedule information collection requirement 9694 (83 FR 3553), of January 23, 2018. 10-digit number; country of origin; bill described below to the Office of For additional information regarding Management and Budget (OMB) for the HTS please follow this link: https:// of lading; house air waybill number; bill of lading issuer code; entry number; review, in accordance with the hts.usitc.gov/current Paperwork Reduction Act. The purpose Change two submitted on March 19, entry type; and estimated shipment value. Three optional data elements are of this notice is to allow for 30 days of 2018: CBP is submitting this Non public comment. Substantive change to reflect an the container stuffing location; consolidator name and address, and DATES: Comments Due Date: May 17, adjustment in ACE Cargo due to U.S. 2018. Department of Commerce Bureau of ship to party name and address. The Industry and Security (BIS) for data collected under the ACE Cargo ADDRESSES: Interested persons are Procedures for Submitting Requests for Release program is intended to reduce invited to submit comments regarding Exclusions from the Section 232 transaction costs, expedite cargo release, this proposal. Comments should refer to National Security Adjustments of and enhance cargo security. ACE Cargo the proposal by name and/or OMB Imports of Steel and Aluminum Release filing minimizes the Control Number and should be sent to: information collection. Importers who redundancy of data submitted by the HUD Desk Officer, Office of have submitted for exclusion from filer to CBP through receiving carrier Management and Budget, New Section 232 shall submit the BIS data from the carrier. This design allows Executive Office Building, Washington, exclusion number in the additional the participants to file earlier in the DC 20503; fax:202–395–5806, Email: importer declaration field. This transportation flow. Guidance on using OIRA [email protected]. collection is authorized by 15 CFR 705, ACE Cargo Release may be found at FOR FURTHER INFORMATION CONTACT: Inez https://www.gpo.gov/fdsys/pkg/CFR- http://www.cbp.gov/trade/ace/features. C. Downs, Reports Management Officer, 2016-title15-vol2/pdf/CFR-2016-title15- Affected Public: Businesses QMAC, Department of Housing and vol2-part705.pdf CBP Form 3461 paper form only: Urban Development, 451 7th Street SW, Type of Review: Extension and Estimated Number of Respondents: Washington, DC 20410; email Revision (with change) 12,307. [email protected], or telephone Abstract: All items imported into the 202–402–8046. This is not a toll-free Estimated Number of Responses per United States are subject to examination number. Person with hearing or speech Respondent: 1. before entering the commerce of the impairments may access this number United States. There are two procedures Estimated Total Annual Responses: through TTY by calling the toll-free available to effect the release of 12,307. Federal Relay Service at (800) 877–8339. imported merchandise, including Estimated Time per Response: 15 Copies of available documents ‘‘entry’’ pursuant to 19 U.S.C. 1484, and minutes. submitted to OMB may be obtained ‘‘immediate delivery’’ pursuant to 19 Estimated Total Annual Burden from Ms. Downs. U.S.C. 1448(b). Under both procedures, Hours: 3,077. SUPPLEMENTARY INFORMATION: This CBP Forms 3461, Entry/Immediate ACE Cargo Release to include notice informs the public that HUD is Delivery, and 3461 ALT are the source electronic submission for 3461/ seeking approval from OMB for the documents in the packages presented to 3461ALT: information collection described in Customs and Border Protection (CBP). Section A. The information collected on CBP Estimated Number of Respondents: 9,810. The Federal Register notice that Forms 3461 and 3461 ALT allow CBP solicited public comment on the Estimated Number of Responses per officers to verify that the information information collection for a period of 60 Respondent: 2,994. regarding the consignee and shipment is days was published on January 16, correct and that a bond is on file with Estimated Total Annual Responses: 2018. CBP. CBP also uses these forms to close 29,371,140. out the manifest and to establish the Estimated Time per Response: 10 A. Overview of Information Collection obligation to pay estimated duties in the minutes. Title of Information Collection: time period prescribed by law or Estimated Total Annual Burden Mortgagor’s Certificate of Actual Cost. regulation. CBP Form 3461 is also a Hours: 4,875,609. OMB Approved Number: 2502–0112. delivery authorization document and is Type of Request: Extension of given to the importing carrier to Dated: April 12, 2018. currently approved collection. authorize the release of the Seth D Renkema, Form Number: HUD–92330. merchandise. Branch Chief, Economic Impact Analysis Description of the need for the CBP Forms 3461 and 3461 ALT are Branch, U.S. Customs and Border Protection. information and proposed use: HUD provided for by 19 CFR 141 and 142. [FR Doc. 2018–08029 Filed 4–16–18; 8:45 am] uses form to obtain data from a These forms and instructions for Form BILLING CODE 9111–14–P mortgagor relative to actual cost of a

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project. HUD uses the cost information SUMMARY: HUD submitted the proposed Respondents: (i.e., affected public): to determine the maximum insurable information collection requirement Business or other for-profit (lenders). mortgage for final endorsement of an described below to the Office of Estimated Number of Respondents: insured mortgage. Actual cost is defined Management and Budget (OMB) for 50. in Section 227c of the National Housing review, in accordance with the Estimated Number of Responses: 420. Act. In addition, form HUD–92330 must Paperwork Reduction Act. The purpose Frequency of Response: 8.40. be accompanied by an audited balance of this notice is to allow for 30 days of Average Hours per Response: 4.25. sheet certified by Certified Public public comment. Total Estimated Burdens: 1,785 hours. Accountant unless the project has less DATES: Comments Due Date: May 17, Solicitation of Public Comment than 40 units, or if it is a refinancing or 2018. a purchase of an existing project under This notice is soliciting comments ADDRESSES: Interested persons are 207/223f or 232/223f. from members of the public and affected invited to submit comments regarding Respondents: 1,206. parties concerning the collection of Estimated Number of Respondents: 1. this proposal. Comments should refer to information described in Section A on Estimated Number of Responses: the proposal by name and/or OMB the following: 1,206. Control Number and should be sent to: (1) Whether the proposed collection Frequency of Response: 1. HUD Desk Officer, Office of of information is necessary for the Average Hours per Response: 8. Management and Budget, New proper performance of the functions of Total Estimated Burdens: 9,648. Executive Office Building, Washington, the agency, including whether the DC 20503; fax:202–395–5806, Email: B. Solicitation of Public Comment _ information will have practical utility; OIRA [email protected]. (2) The accuracy of the agency’s This notice is soliciting comments FOR FURTHER INFORMATION CONTACT: estimate of the burden of the proposed from members of the public and affected Colette Pollard, Reports Management collection of information; parties concerning the collection of Officer, QMAC, Department of Housing (3) Ways to enhance the quality, information described in Section A on and Urban Development, 451 7th Street utility, and clarity of the information to the following: SW, Washington, DC 20410; email be collected; and (1) Whether the proposed collection [email protected], or telephone (4) Ways to minimize the burden of of information is necessary for the 202–402–3400. This is not a toll-free the collection of information on those proper performance of the functions of number. Person with hearing or speech who are to respond: including through the agency, including whether the impairments may access this number the use of appropriate automated information will have practical utility; through TTY by calling the toll-free collection techniques or other forms of (2) The accuracy of the agency’s Federal Relay Service at (800) 877–8339. information technology, e.g., permitting estimate of the burden of the proposed Copies of available documents electronic submission of responses. collection of information; submitted to OMB may be obtained HUD encourages interested parties to (3) Ways to enhance the quality, from Ms. Pollard. utility, and clarity of the information to submit comment in response to these SUPPLEMENTARY INFORMATION: This questions. be collected; and notice informs the public that HUD is (4) Ways to minimize the burden of Authority: Section 3507 of the Paperwork seeking approval from OMB for the the collection of information on those Reduction Act of 1995, 44 U.S.C. Chapter 35. information collection described in who are to respond: Including through Section A. Dated: April 5 2018. the use of appropriate automated The Federal Register notice that Colette Pollard, collection techniques or other forms of solicited public comment on the Department Reports Management Officer, information technology, e.g., permitting information collection for a period of 60 Office of the Chief Information Officer. electronic submission of responses. days was published on February 7, 2018 [FR Doc. 2018–07935 Filed 4–16–18; 8:45 am] HUD encourages interested parties to at 83 FR 5455. BILLING CODE 4210–67–P submit comment in response to these questions. A. Overview of Information Collection Authority: Section 3507 of the Paperwork Title of Information Collection: DEPARTMENT OF HOUSING AND Reduction Act of 1995, 44 U.S.C. Chapter 35. Energy Efficient Mortgages (EEMs). URBAN DEVELOPMENT OMB Approval Number: 2502–0561. Dated: April 4, 2018. [Docket No. FR–6068–D–02] Inez C. Downs, Type of Request: Extension of currently approved collection. Redelegation of Authority to the Department Reports Management Officer, Form Number: None. Office of the Chief Information Officer. General Deputy Assistant Secretary for Description of the Need for the Administration [FR Doc. 2018–07936 Filed 4–16–18; 8:45 am] Information and Proposed Use: Lenders BILLING CODE 4210–67–P provide the required information to AGENCY: Office of the Assistant determine the eligibility of a mortgage to Secretary for Administration, HUD. be insured under Section 513 of the DEPARTMENT OF HOUSING AND ACTION: Notice of redelegation of Housing and Community Development URBAN DEVELOPMENT authority. Act of 1992 (Section 106 of the Energy [Docket No. FR–7001–N–11] Policy Act of 1992). Section 2123 of the SUMMARY: Through this notice, the Housing and Economic Recovery Act of Assistant Secretary for Administration 30-Day Notice of Proposed Information 2008 (HERA) (Pub. L. 110–289, redelegates to the General Deputy Collection: Energy Efficient Mortgages approved July 30, 2008) amended Assistant Secretary for Administration (EEMs) Section 106 of the Energy Policy Act of concurrent authority, vested in or AGENCY: Office of the Chief Information 1992 by revising the maximum dollar delegated or assigned to the Assistant Officer, HUD. amount that can be added to an FHA- Secretary for Administration, including insured mortgage for energy efficient authority and responsibility for the ACTION: Notice. improvements. coordination, management and

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supervision for the following offices: retirement; and human capital Dated: April 10, 2018. Chief Human Capital Officer, Chief information systems. More detailed Suzanne Israel Tufts, Procurement Officer, and Chief information can be found in the Assistant Secretary for Administration. Administrative Officer. delegation of authority notice for the [FR Doc. 2018–07921 Filed 4–11–18; 4:15 pm] DATES: This redelegation of authority is Chief Human Capital Officer, posted at BILLING CODE 4210–67–P applicable upon signature. https://www.hud.gov/sites/documents/ _ FOR FURTHER INFORMATION CONTACT: John 5562-D-01 DELEGATION.PDF. B. Shumway, Assistant General Counsel 2. Office of the Chief Procurement DEPARTMENT OF THE INTERIOR for Administrative Law, Office of Officer: This office is responsible for General Counsel, Department of obtaining all contracted goods and Bureau of Safety and Environmental Housing and Urban Development, 451 services required by the Department Enforcement efficiently and in the most cost-effective 7th Street SW, Room 9262, Washington, [Docket ID BSEE–2018–0012; 189E1700D2 DC 20410–0500, telephone number 202– manner possible to enable the ET1SF0000.PSB000.EEEE500000; OMB 402–5190. (This is not a toll-free Department to meet its strategic Control Number 1014–0005] number.) Individuals with speech or objectives. The office provides logistical hearing impairments may access this support to HUD’s program offices and Agency Information Collection number through TTY by calling 1–800– other support offices in meeting their Activities; Relief or Reduction in 877–8339. mission needs and provides leadership Royalty Rates SUPPLEMENTARY INFORMATION: In January on developing fundamentally sound business practices. This redelegation AGENCY: Bureau of Safety and 2018, the Deputy Secretary delegated Environmental Enforcement, Interior. authority to the Assistant Secretary for does not include the authority to ACTION: Notice of information collection; Administration, which was published in perform the duties and functions of the request for comment. the Federal Register at 83 FR 3764. In Chief Acquisition Officer, which was provided to the Assistant Secretary for that notice, the Assistant Secretary for SUMMARY: In accordance with the Administration and, if the Assistant Administration was authorized to Paperwork Reduction Act of 1995, the Secretary for Administration position is redelegate to employees of HUD the Bureau of Safety and Environmental vacant, the Senior Procurement authority delegated by the Deputy Enforcement (BSEE) proposes to renew Executive in a designation notice Secretary. Through this notice, the an information collection. published in the Federal Register at 83 Assistant Secretary for Administration DATES: Interested persons are invited to hereby redelegates to the General FR 3765. The functions of the Chief Acquisition Officer are outlined at 41 submit comments on or before June 18, Deputy Assistant Secretary for 2018. Administration concurrent authority, U.S.C. 1702. ADDRESSES: Send your comments on vested in or delegated or assigned to the 3. Office of the Chief Administrative Officer: This office is responsible for this information collection request (ICR) Assistant Secretary for Administration by either of the following methods listed including the authority to coordinate, headquarters and field support services, Executive Secretariat and compliance below: manage and supervise the activities of • Electronically go to http:// the offices of the Chief Human Capital functions (including privacy, records, and Freedom of Information Act www.regulations.gov. In the Search box, Officer, the Chief Procurement Officer, enter BSEE–2018–0012 then click and the Chief Administrative Officer. compliance), facilities management, disaster management, national security, search. Follow the instructions to This redelegation of authority does not submit public comments and view all include the authority to perform the security of the Secretary, Deputy Secretary, and of the various HUD related materials. We will post all duties and functions of the Chief comments. Acquisition Officer, which was buildings, and communication support • services, including digital and Email [email protected], fax provided to the Assistant Secretary for (703) 787–1546, or mail or hand-carry Administration and, if the Assistant multimedia. More detailed information can be found in the delegation of comments to the Department of the Secretary for Administration position is Interior; Bureau of Safety and vacant, the Senior Procurement authority notice for the Chief Administrative Officer, posted at Environmental Enforcement; Executive in a designation published in Regulations and Standards Branch; the Federal Register at 83 FR 3765. https://www.hud.gov/sites/documents/ DOAADMIN071814.PDF. ATTN: Kelly Odom; 45600 Woodland Section A. Authority Road, Sterling, VA 20166. Please Section B. Authority to Redelegate reference OMB Control Number 1014– The Assistant Secretary for 0005 in the subject line of your Administration hereby redelegates to The General Deputy Assistant comments. the General Deputy Assistant Secretary Secretary for Administration is for Administration the concurrent authorized to redelegate to employees of FOR FURTHER INFORMATION CONTACT: To authority to coordinate, manage and HUD any of the authority delegated request additional information about supervise the activities of the following under Section A above. this ICR, contact Kelly Odom by email at [email protected] or by telephone offices and functions: Section C. Authority Superseded 1. Office of the Chief Human Capital at (703) 787–1775. Officer: This office is responsible for This delegation does not supersede SUPPLEMENTARY INFORMATION: In employee performance management; the previous delegation of authority accordance with the Paperwork executive resources; human capital from the Deputy Secretary to the Reduction Act of 1995, we provide the headquarters and field support; human Assistant Secretary of Administration, general public and other Federal capital policy; planning and training; which was published in the Federal agencies with an opportunity to recruitment and staffing; personnel Register at 83 FR 3764. comment on new, proposed, revised, security; employee assistance program; Authority: Section 7(d), Department of and continuing collections of health and wellness; employee and Housing and Urban Development Act (42 information. This helps us assess the labor relations; pay; benefits and U.S.C. 3535(d)). impact of our information collection

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requirements and minimize the public’s Respondents/Affected Public: by either of the following methods listed reporting burden. It also helps the Potential respondents comprise Federal below: public understand our information OCS oil, gas, and sulfur lessees/ • Electronically go to http:// collection requirements and provide the operators. www.regulations.gov. In the Search box, requested data in the desired format. Total Estimated Number of Annual enter BSEE–2018–0010 then click We are soliciting comments on the Respondents: Varies, not all of the search. Follow the instructions to proposed ICR that is described below. potential respondents will submit submit public comments and view all We are especially interested in public information in any given year and some related materials. We will post all comments addressing the following may submit multiple times. comments. issues: (1) Is the collection necessary to Total Estimated Number of Annual • Email [email protected], fax the proper functions of BSEE; (2) Will Responses: 16. (703) 787–1546, or mail or hand-carry this information be processed and used Estimated Completion Time per comments to the Department of the in a timely manner; (3) Is the estimate Response: Varies from 1 hour to 2,000 Interior; Bureau of Safety and of burden accurate; (4) How might BSEE hours, depending on activity. Environmental Enforcement; enhance the quality, utility, and clarity Total Estimated Number of Annual Regulations and Standards Branch; of the information to be collected; and Burden Hours: 724. ATTN: Nicole Mason; 45600 Woodland (5) How might BSEE minimize the Respondent’s Obligation: Most Road, Sterling, VA 20166. Please burden of this collection on the responses are mandatory, while others reference OMB Control Number 1014– respondents, including through the use are required to obtain or retain benefits. 0008 in the subject line of your Frequency of Collection: On occasion. comments. of information technology. Total Estimated Annual Nonhour Comments that you submit in Burden Cost: We have identified FOR FURTHER INFORMATION CONTACT: To response to this notice are a matter of application and audit fees; as well as an request additional information about public record. We will include or independent certified public accountant this ICR, contact Nicole Mason by email summarize each comment in our request report. The non-hour cost burdens at [email protected] or by telephone to OMB to approve this ICR. Before associated with this collection of at (703) 787–1607. including your address, phone number, information amount to $27,950. SUPPLEMENTARY INFORMATION: In email address, or other personal An agency may not conduct or accordance with the Paperwork identifying information in your sponsor and a person is not required to Reduction Act of 1995, we provide the comment, you should be aware that respond to a collection of information general public and other Federal your entire comment—including your unless it displays a currently valid OMB agencies with an opportunity to personal identifying information—may control number. comment on new, proposed, revised, be made publicly available at any time. The authority for this action is the and continuing collections of While you can ask us in your comment Paperwork Reduction Act of 1995 (44 information. This helps us assess the to withhold your personal identifying U.S.C. 3501 et seq). impact of our information collection information from public review, we Dated: March 15, 2018. requirements and minimize the public’s cannot guarantee that we will be able to Doug Morris, reporting burden. It also helps the do so. public understand our information Chief, Office of Offshore Regulatory Programs. Abstract: The regulations at 30 CFR collection requirements and provide the part 203, concern relief or reduction in [FR Doc. 2018–07974 Filed 4–16–18; 8:45 am] requested data in the desired format. royalty rates and are the subject of this BILLING CODE 4310–VH–P We are soliciting comments on the collection. This request also covers any proposed ICR that is described below. related Notices to Lessees and Operators We are especially interested in public DEPARTMENT OF THE INTERIOR (NTLs) that BSEE issues to clarify, comments addressing the following supplement, or provide additional Bureau of Safety and Environmental issues: (1) Is the collection necessary to guidance on some aspects of our Enforcement the proper functions of BSEE; (2) Will regulations. this information be processed and used The BSEE uses the information to [Docket ID BSEE–2018–0010; 189E1700D2 in a timely manner; (3) Is the estimate make decisions on the economic ET1SF0000.PSB000.EEEE500000; OMB of burden accurate; (4) How might BSEE viability of leases requesting a Control Number 1014–0008] enhance the quality, utility, and clarity suspension or elimination of royalty or Agency Information Collection of the information to be collected; and net profit share. These decisions have Activities; Well Control and Production (5) How might BSEE minimize the enormous monetary impact on both the Safety Training burden of this collection on the lessee and the Federal Government. respondents, including through the use Royalty relief can lead to increased AGENCY: Bureau of Safety and of information technology. production of natural gas and oil, Environmental Enforcement, Interior. Comments that you submit in creating profits for lessees, and royalty ACTION: Notice of information collection; response to this notice are a matter of and tax revenues for the Federal request for comment. public record. We will include or Government that they might not summarize each comment in our request otherwise receive. We could not make SUMMARY: In accordance with the to OMB to approve this ICR. Before an informed decision without the Paperwork Reduction Act of 1995, the including your address, phone number, collection of information required by 30 Bureau of Safety and Environmental email address, or other personal CFR part 203. Enforcement (BSEE) proposes to renew identifying information in your Title of Collection: 30 CFR part 203, an information collection. comment, you should be aware that Relief or Reduction in Royalty Rates. DATES: Interested persons are invited to your entire comment—including your OMB Control Number: 1014–0005. submit comments on or before June 18, personal identifying information—may Form Number: None. 2018. be made publicly available at any time. Type of Review: Extension of a ADDRESSES: Send your comments on While you can ask us in your comment currently approved collection. this information collection request (ICR) to withhold your personal identifying

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information from public review, we Dated: March 5, 2018. obtain information on this matter by cannot guarantee that we will be able to Doug Morris, contacting the Commission’s TDD do so. Chief, Office of Offshore Regulatory Programs. terminal at 202–205–1810. General Abstract: The regulations at 30 CFR [FR Doc. 2018–07976 Filed 4–16–18; 8:45 am] information concerning the Commission part 250, subpart O, concern well BILLING CODE 4310–VH–P may also be obtained by accessing its control and production safety training internet server (http://www.usitc.gov). and are the subject of this collection. Persons with mobility impairments who This request also covers any related will need special assistance in gaining INTERNATIONAL TRADE access to the Commission should Notices to Lessees and Operators (NTLs) COMMISSION that BSEE issues to clarify, supplement, contact the Office of the Secretary at or provide additional guidance on some [Investigation No. U.S.-Korea FTA–103–031] 202–205–2000. aspects of our regulations. Background: In his request letter (received April 6, 2018), the USTR The BSEE will use the information U.S.-Korea FTA: Advice on stated that U.S. negotiators have collected under subpart O regulations to Modifications to Duty Rates for Certain recently reached an agreement in ensure that workers in the OCS are Motor Vehicles principle with representatives of the properly trained with the necessary AGENCY: United States International government of Korea on modifications skills to perform their jobs in a safe and Trade Commission. to the FTA regarding the staging of duty pollution-free manner. ACTION: Institution of investigation and treatment for certain motor vehicles. In some instances, we may conduct notice of opportunity to provide written The USTR noted that section 201(b)(2) oral interviews of offshore employees to comments. of the United States—Korea Free Trade evaluate the effectiveness of a Agreement Implementation Act (the company’s training program. The oral SUMMARY: Following receipt on April 6, Act) authorizes the President, subject to interviews are used to gauge how 2018, of a request from the U.S. Trade the consultation and layover effectively the companies are Representative (USTR), the Commission requirements of section 104 of the Act, implementing their own training instituted investigation No. U.S.-Korea to proclaim such tariff modifications as program. FTA–103–031, U.S.-Korea FTA: Advice the President determines to be necessary Title of Collection: 30 CFR 250, on Modifications to Duty Rates for or appropriate to maintain the general Subpart O, Well Control and Production Certain Motor Vehicles, for the purpose level of reciprocal and mutually Safety Training. of providing advice on the probable advantageous concessions with respect OMB Control Number: 1014–0008. economic effect of modifications to the to Korea provided for by the FTA. He Form Number: None. United States-Korea Free Trade noted that one of the requirements set Agreement regarding the staging of duty Type of Review: Extension of a out in section 104 of the Act is that the treatment for certain motor vehicles. currently approved collection. President obtain advice regarding the DATES: proposed action from the U.S. Respondents/Affected Public: May 1, 2018: Deadline for filing International Trade Commission. Potential respondents comprise Federal written submissions. June 1, 2018: Transmittal of In the request letter, the USTR asked OCS oil, gas, and sulfur lessees/ that the Commission provide advice on operators and holders of pipeline rights- Commission report to USTR. ADDRESSES: All Commission offices, the probable economic effect of the of-way. modifications on U.S. trade under the Total Estimated Number of Annual including the Commission’s hearing rooms, are located in the United States FTA and on domestic producers of the Respondents: Varies, not all of the affected articles. He asked that the potential respondents will submit International Trade Commission Building, 500 E Street SW, Washington, Commission provide its advice at the information in any given year and some earliest possible date but no later than may submit multiple times. DC. All written submissions should be addressed to the Secretary, United eight weeks from receipt of the request. Total Estimated Number of Annual States International Trade Commission, He also asked that the Commission Responses: 6. 500 E Street SW, Washington, DC issue, as soon as possible thereafter, a Estimated Completion Time per 20436. The public record for this public version of its report with any Response: Varies from 1 hour to 105 investigation may be viewed on the confidential business information hours, depending on activity. Commission’s electronic docket (EDIS) deleted. The products identified in the Total Estimated Number of Annual at http://www.usitc.gov/secretary/ proposal are motor vehicles for the Burden Hours: 202. edis.htm. Respondent’s Obligation: Most transport of goods provided for in FOR FURTHER INFORMATION CONTACT: responses are mandatory, while others subheadings 8704.21.00, 8704.22.50, Project Leader Jeff Horowitz (202–205– are required to obtain or retain benefits. 8704.23.00, 8704.31.00, 8704.32.00, and 2750 or [email protected]) or 8704.90.00 of the U.S. Harmonized Frequency of Collection: On occasion. Deputy Project Leader Mitch Semanik Tariff Schedule. The request letter and Total Estimated Annual Nonhour (202–205–2034 or mitchell.semanik@ the proposed modification are available Burden Cost: We have not identified any usitc.gov) for information specific to this on the Commission’s website at http:// non-hour cost burdens associated with investigation. For information on the www.usitc.gov/research_and_analysis/ this collection of information. legal aspects of this investigation, what_we_are_working_on.htm. As An agency may not conduct or contact William Gearhart of the requested, the Commission will provide sponsor and a person is not required to Commission’s Office of the General its advice to USTR by June 1, 2018. respond to a collection of information Counsel (202–205–3091 or Written Submissions: No public unless it displays a currently valid OMB [email protected]). The media hearing is planned. However, interested control number. should contact Margaret O’Laughlin, parties are invited to file written The authority for this action is the Office of External Relations (202–205– submissions. All written submissions Paperwork Reduction Act of 1995 (44 1819 or [email protected]). should be addressed to the Secretary, U.S.C. 3501 et seq). Hearing-impaired individuals may and should be received no later than

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5:15 p.m., May 1, 2018. All written Commission including under 5 U.S.C. proposed registration on or before May submissions must conform with the Appendix 3; or (ii) by U.S. government 17, 2018. Such persons may also file a provisions of section 201.8 of the employees and contract personnel for written request for a hearing on the Commission’s Rules of Practice and cybersecurity purposes. The application on or before May 17, 2018. Procedure (19 CFR 201.8). Section 201.8 Commission will not otherwise disclose ADDRESSES: and the Commission’s Handbook on any confidential business information in Written comments should Filing Procedures require that interested a manner that would reveal the be sent to: Drug Enforcement parties file documents electronically on operations of the firm supplying the Administration, Attention: DEA Federal or before the filing deadline and submit information. Register Representative/DRW, 8701 eight (8) true paper copies by 12:00 p.m. Summaries Of Written Submissions: Morrissette Drive, Springfield, Virginia eastern time on the next business day. The Commission intends to publish 22152. All requests for hearing must be In the event that confidential treatment summaries of the positions of interested sent to: Drug Enforcement of a document is requested, interested persons in an appendix to its report. Administration, Attn: Administrator, parties must file, at the same time as the Persons wishing to have a summary of 8701 Morrissette Drive, Springfield, eight paper copies, at least four (4) their position included in the appendix Virginia 22152. All request for hearing additional true paper copies in which should include a summary with their should also be sent to: (1) Drug the confidential information must be written submission. The summary may Enforcement Administration, Attn: deleted (see the following paragraph for not exceed 500 words, should be in Hearing Clerk/LJ, 8701 Morrissette further information regarding MSWord format or a format that can be Drive, Springfield, Virginia 22152; and confidential business information). easily converted to MSWord, and (2) Drug Enforcement Administration, Persons with questions regarding should not include any CBI. The Attn: DEA Federal Register electronic filing should contact the summary will be included in the report Representative/DRW, 8701 Morrissette Office of the Secretary, Docket Services as provided if it meets these Drive, Springfield, Virginia 22152. Division (202–205–1802). requirements and is germane to the Comments and requests for hearings on Confidential Business Information: subject matter of the investigation. In applications to import narcotic raw Any submissions that contain the appendix, the Commission will material are not appropriate. 72 FR confidential business information must identify the name of the organization 3417, (January 25, 2007) also conform with the requirements of furnishing the summary and will SUPPLEMENTARY INFORMATION: The section 201.6 of the Commission’s Rules include a link to the Commission’s Attorney General has delegated his of Practice and Procedure (19 CFR Electronic Document Information authority under the Controlled 201.6). Section 201.6 of the rules System (EDIS) where the full written Substances Act to the Administrator of requires that the cover of the document submission can be found. the Drug Enforcement Administration and the individual pages be clearly (DEA), 28 CFR 0.100(b). Authority to marked as to whether they are the By order of the Commission. exercise all necessary functions with ‘‘confidential’’ or ‘‘non-confidential’’ Issued: April 12, 2018. respect to the promulgation and version, and that the confidential Lisa Barton, implementation of 21 CFR part 1301, business information is clearly Secretary to the Commission. incident to the registration of identified by means of brackets. All [FR Doc. 2018–08015 Filed 4–16–18; 8:45 am] manufacturers, distributors, dispensers, written submissions, except for those BILLING CODE 7020–02–P importers, and exporters of controlled containing CBI, will be made available substances (other than final orders in for inspection by interested parties. connection with suspension, denial, or The Commission may include some or DEPARTMENT OF JUSTICE all of the confidential business revocation of registration) has been redelegated to the Assistant information submitted in the course of Drug Enforcement Administration this investigation in the report it sends Administrator of the DEA Diversion to the USTR. Additionally, all [Docket No. DEA–392] Control Division (‘‘Assistant information, including CBI, submitted Administrator’’) pursuant to section 7 of Importer of Controlled Substances 28 CFR part 0, appendix to subpart R. in this investigation may be disclosed to Application: Clinical Supplies and used: (i) By the Commission, its Management Holdings, Inc. In accordance with 21 CFR employees and Offices, and contract 1301.34(a), this is notice that on March personnel (a) for developing or ACTION: Notice of application. 14, 2018, Clinical Supplies Management maintaining the records of this or a Holdings, Inc., 342 42nd Street South, related proceeding, or (b) in internal DATES: Registered bulk importers of the Fargo, ND 58103 applied to be investigations, audits, reviews, and affected basic classes, and applicants registered as an importer of the evaluations relating to the programs, therefore, may file written comments on following basic classes of controlled personnel, and operations of the or objections to the issuance of the substances:

Controlled substance Drug code Schedule

Marihuana ...... 7360 I Tetrahydrocannabinols ...... 7370 I

The company plans to import automatic approval of subsequent under 21 U.S.C. 952(a)(2). Authorization analytical reference standards for permit applications to import controlled will not extend to the import of FDA distribution to its customers for research substances. Approval of permit approved or non-approved finished and analytical purposes. Placement of applications will occur only when the dosage forms for commercial sale. these drug codes onto the company’s registrant’s business activity is registration does not translate into consistent with what is authorized

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Dated: April 10, 2018. additional information, please contact 2. Title of the Form/Collection: Susan A. Gibson, Michael J. Lewis, Diversion Control Application for Registration, Deputy Assistant Administrator. Division, Drug Enforcement Application for Registration Renewal. [FR Doc. 2018–07978 Filed 4–16–18; 8:45 am] Administration; Mailing Address: 8701 3. The agency form number, if any, BILLING CODE 4410–09–P Morrissette Drive, Springfield, Virginia and the applicable component of the 22152; Telephone: (202) 598–6812 or Department sponsoring the collection: sent to [email protected]. The form numbers are DEA Forms 363, DEPARTMENT OF JUSTICE SUPPLEMENTARY INFORMATION: Written 363a. The applicable component within the Department of Justice is the Drug [OMB Number 1117–0015] comments and suggestions from the public and affected agencies concerning Enforcement Administration, Diversion Agency Information Collection the proposed collection of information Control Division. Activities; Proposed eCollection, are encouraged. Your comments should 4. Affected public who will be asked eComments Requested; Extension address one or more of the following or required to respond, as well as a brief Without Change of a Previously four points: abstract: Affected public: Business or other for- Approved Collection; Application for —Evaluate whether the proposed Registration, Application for profit. collection of information is necessary Affected public (Other): Not-for-profit Registration Renewal; DEA Forms 363, for the proper performance of the 363a institutions, Federal, State, local, and functions of the agency, including tribal governments. AGENCY: Drug Enforcement whether the information will have Abstract: The Controlled Substances Administration, Department of Justice. practical utility; Act requires practitioners who dispense ACTION: 30-Day Notice. —Evaluate the accuracy of the agency’s narcotic drugs to individuals for estimate of the burden of the maintenance or detoxification treatment SUMMARY: The Department of Justice proposed collection of information, to register annually with DEA.1 21 (DOJ), Drug Enforcement including the validity of the U.S.C. 822, 823; 21 CFR 1301.11 and Administration (DEA), will be methodology and assumptions used; 1301.13. Registration is a necessary submitting the following information —Evaluate whether and if so how the control measure and helps to prevent collection request to the Office of quality, utility, and clarity of the diversion by ensuring the closed system Management and Budget (OMB) for information proposed to be collected of distribution of controlled substances review and approval in accordance with can be enhanced; and can be monitored by DEA and the the Paperwork Reduction Act of 1995. —Minimize the burden of the collection businesses and individuals handling The proposed information collection of information on those who are to controlled substances are qualified to do was previously published in the Federal respond, including through the use of so and are accountable. Register, on February 21, 2018, allowing appropriate automated, electronic, 5. An estimate of the total number of for a 60 day comment period. mechanical, or other forms of respondents and the amount of time DATES: Comments are encouraged and information technology, e.g., estimated for an average respondent to will be accepted for 30 days until May permitting electronic submission of respond: DEA Form 363 is submitted on 17, 2018. responses. an as needed basis by persons seeking FOR FURTHER INFORMATION CONTACT: If to become registered; DEA Form 363a is Overview of This Information you have comments on the estimated submitted on an annual basis thereafter Collection public burden or associated response to renew existing registrations. The time, suggestions, or need a copy of the 1. Type of Information Collection: below table presents information proposed information collection Extension of a currently approved regarding the number of respondents, instrument with instructions or collection. responses and associated burden hours.

Number of annual Average time per response Total annual respondents hours

DEA Form 363 (paper) ...... 15 0.30 hours (18 minutes) ...... 5 DEA Form 363 (online) ...... 223 0.13 hours (8 minutes) ...... 30 DEA Form 363a (paper) ...... 51 0.22 hours (13 minutes) ...... 11 DEA Form 363a (online) ...... 1,437 0.10 hours (6 minutes) ...... 144

Total ...... 1,726 ...... 189 Figures are rounded.

6. An estimate of the total public Department Clearance Officer, United Dated: April 11, 2018. burden (in hours) associated with the States Department of Justice, Justice Melody Braswell, proposed collection: The DEA estimates Management Division, Policy and Department Clearance Officer for PRA, U.S. that this collection takes 189 annual Planning Staff, Two Constitution Department of Justice. burden hours. Square, 145 N Street NE, Suite 3E.405B, [FR Doc. 2018–07904 Filed 4–16–18; 8:45 am] If additional information is required Washington, DC 20530. BILLING CODE 4410–09–P please contact: Melody Braswell,

1 This registration requirement is waived for certain practitioners under specified circumstances. See 21 U.S.C. 823(g)(2).

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DEPARTMENT OF JUSTICE —Evaluate the accuracy of the agency’s estimated for an average respondent to estimate of the burden of the respond: 11,192 respondents per year at Civil Rights Division collection of information, including 0.75 hours per complaint form. the validity of the methodology and 6. An estimate of the total public [OMB Number 1190–0009] assumptions used; burden (in hours) associated with the —Evaluate whether and if so, how, the collection: The estimated annual public Agency Information Collection quality, utility, and clarity of the burden associated with this collection is Activities; Proposed eCollection information to be collected can be 8,394 hours, which is equal to 11,192 eComments Requested; Extension enhanced; and respondents * .75 hours. Without Change of a Currently- —Minimize the burden of the collection If additional information is required Approved Collection, Title II of the of information on those who are to contact: Melody Braswell, Department Americans With Disabilities Act of respond, including through the use of Clearance Officer, United States 1990/Section 504 of the Rehabilitation appropriate automated, electronic, Department of Justice, Justice Act of 1973 Discrimination Complaint mechanical, or other technological Management Division, Policy and Form collection techniques or other forms Planning Staff, Two Constitution of information technology (e.g., AGENCY: Disability Rights Section, Civil Square, 145 N Street NE, 3E.405A, permitting electronic submission of Washington, DC 20530. Rights Division, U.S. Department of responses). Justice. Dated: April 12, 2018. ACTION: 60 Day notice. Overview of This Information Melody Braswell, Collection Department Clearance Officer for PRA, U.S. SUMMARY: The Department of Justice, 1. Type of information collection: Department of Justice. Civil Rights Division, Disability Rights Extension of Currently Approved [FR Doc. 2018–07979 Filed 4–16–18; 8:45 am] Section, is submitting the following Collection. BILLING CODE 4410–13–P information collection request to the 2. The Title of the Form/Collection: Office of Management and Budget Title II of the Americans with (OMB) for review and approval in Disabilities Act/Section 504 of the DEPARTMENT OF JUSTICE accordance with the Paperwork Rehabilitation Act of 1973 [OMB Number 1117–0012] Reduction Act of 1995. Discrimination Complaint Form. DATES: The Department of Justice 3. The agency form number and Agency Information Collection encourages public comment and will applicable component of the Activities; Proposed eCollection, accept input until June 18, 2018. Department sponsoring the collection: eComments Requested; Extension Comments received after the close of The document has no agency form Without Change of a Previously the comment period are disfavored and number. The applicable component Approved Collection; Application for will be marked ‘‘late.’’ The Department within the Department of Justice is the Registration, Application for is not required to consider late Disability Rights Section, Civil Rights Registration Renewal, Affidavit for comments. Division. Chain Renewal; DEA Forms 225, 225a 4. Affected public who will be asked FOR FURTHER INFORMATION CONTACT: If and 225b to respond, as well as a brief abstract: you have additional comments, Primary: Individuals alleging AGENCY: Drug Enforcement especially on the estimated public discrimination by public entities based Administration, Department of Justice. burden or associated response time, on disability. Under title II of the ACTION: 30-Day notice. suggestions, or need a copy of the Americans with Disabilities Act, an proposed information collection individual who believes that he or she SUMMARY: The Department of Justice instrument with instructions or has been subjected to discrimination on (DOJ), Drug Enforcement additional information, please contact the basis of disability by a public entity Administration (DEA), will be Rebecca Bond, Chief, U.S. Department may, by himself or herself or by an submitting the following information of Justice, Civil Rights Division, authorized representative, file a collection request to the Office of Disability Rights Section, NYA, 950 complaint. The Department of Justice Management and Budget (OMB) for Pennsylvania Avenue NW, Washington, must address the complaint or refer the review and approval in accordance with DC 20530, [email protected], or by complaint to the appropriate Federal the Paperwork Reduction Act of 1995. telephone at (800) 514–0301 (Voice) or agency. Any Federal agency that The proposed information collection (800) 514–0383 (TTY) (the Division’s receives a complaint of discrimination was previously published in the Federal ADA Information Line). All submissions on the basis of disability by a public Register, on February 21, 2018, allowing should reference the eight-digit OMB entity must review the complaint to for a 60-day comment period. number for the collection or the title of determine whether it has jurisdiction DATES: Comments are encouraged and the collection. under Section 504. If the agency does will be accepted for 30 days until May SUPPLEMENTARY INFORMATION: Written not have jurisdiction under Section 504, 17, 2018. comments and suggestions from the it must determine whether it is the FOR FURTHER INFORMATION CONTACT: If public and affected agencies concerning designated agency responsible for you have comments on the estimated the proposed collection of information complaints filed against that public public burden or associated response are encouraged. Your comments should entity under title II of the ADA. If the time, suggestions, or need a copy of the address one or more of the following agency does not have jurisdiction under proposed information collection four points: section 504 and is not the designated instrument with instructions or —Evaluate whether the collection of agency under title II of the ADA, it must additional information, please contact information is necessary for the refer the complaint to the Department of Michael J. Lewis, Diversion Control proper performance of the function of Justice. Division, Drug Enforcement the agency, including whether the 5. An estimate of the total number of Administration; Mailing Address: 8701 information will have practical utility; respondents and the amount of time Morrissette Drive, Springfield, Virginia

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22152; Telephone: (202) 598–6812 or appropriate automated, electronic, Affected public: Business or other for- sent to [email protected]. mechanical, or other forms of profit. SUPPLEMENTARY INFORMATION: Written information technology, e.g., Affected public (Other): Not-for-profit comments and suggestions from the permitting electronic submission of institutions, Federal, State, local, and public and affected agencies concerning responses. tribal governments. the proposed collection of information Overview of This Information Abstract: The Controlled Substances are encouraged. Your comments should Collection Act requires all businesses and address one or more of the following individuals who manufacture, four points: 1. Type of Information Collection: distribute, import, export, and conduct —Evaluate whether the proposed Extension of a currently approved research and laboratory analysis with collection of information is necessary collection. controlled substances to register with for the proper performance of the 2. Title of the Form/Collection: DEA. 21 U.S.C. 822, 21 CFR 1301.11 and functions of the agency, including Application for Registration, 1301.13. Registration is a necessary whether the information will have Application for Registration Renewal, control measure and helps to prevent practical utility; Affidavit for Chain Renewal. diversion by ensuring the closed system —Evaluate the accuracy of the agency’s 3. The agency form number, if any, of distribution of controlled substances estimate of the burden of the and the applicable component of the can be monitored by DEA and the proposed collection of information, Department sponsoring the collection: businesses and individuals handling including the validity of the The form numbers are DEA Forms 225, controlled substances are qualified to do methodology and assumptions used; 225a, and 225b. The applicable so and are accountable. —Evaluate whether and if so how the component within the Department of 5. An estimate of the total number of quality, utility, and clarity of the Justice is the Drug Enforcement respondents and the amount of time information proposed to be collected Administration, Diversion Control estimated for an average respondent to can be enhanced; and Division. respond: The below table presents —Minimize the burden of the collection 4. Affected public who will be asked information regarding the number of of information on those who are to or required to respond, as well as a brief respondents, responses and associated respond, including through the use of abstract: burden hours.

Number of annual Average time per response Total annual respondents hours

DEA–225 (paper) ...... 308 0.33 hours (20 minutes) ...... 103 DEA–225 (online) ...... 1,993 0.17 hours (10 minutes) ...... 332 DEA–225a (paper) ...... 366 0.25 hours (15 minutes) ...... 92 DEA–225a (online) ...... 13,248 0.12 hours (7 minutes) ...... 1,546 DEA–225b (chain renewal) * ...... 4 1 hour ...... 4

Total ...... 15,919 ...... 2,076 * In total, 4 chains represent 82 individual registrant locations. Figures are rounded.

6. An estimate of the total public DEPARTMENT OF JUSTICE DEPARTMENT OF JUSTICE burden (in hours) associated with the proposed collection: The DEA estimates Parole Commission Parole Commission that this collection takes 2,076 annual Sunshine Act Meeting burden hours. Sunshine Act Meeting If additional information is required TIME AND DATE: 11:00 a.m. Tuesday, TIME AND DATE: 12:00 a.m., Tuesday, please contact: Melody Braswell, April 24, 2018 April 24, 2018. Department Clearance Officer, United States Department of Justice, Justice PLACE: U.S. Parole Commission, 90 K PLACE: U.S. Parole Commission, 90 K Management Division, Policy and Street NE, 3rd Floor, Washington, DC. Street NE, 3rd Floor, Washington, DC. STATUS: Planning Staff, Two Constitution Open. STATUS: Closed. Square, 145 N Street NE, Suite 3E.405B, MATTERS TO BE CONSIDERED: Approval of MATTERS TO BE CONSIDERED: Washington, DC 20530. February 13, 2018 minutes; Reports Determination on ONE original Dated: April 11, 2018. from the Vice Chairman, Commissioners jurisdiction cases. Melody Braswell, and Senior Staff. CONTACT PERSON FOR MORE INFORMATION: Department Clearance Officer for PRA, U.S. CONTACT PERSON FOR MORE INFORMATION: Department of Justice. Jacqueline Graham, Staff Assistant to Jacqueline Graham, Staff Assistant to [FR Doc. 2018–07905 Filed 4–16–18; 8:45 am] the Chairman, U.S. Parole Commission, the Chairman, U.S. Parole Commission, 90 K Street NE, 3rd Floor, Washington, BILLING CODE 4410–09–P 90 K Street NE, 3rd Floor, Washington, DC 20530, (202) 346–7010. DC. 20530, (202) 346–7001. Dated: April 13, 2018. Dated: April 13, 2018. J. Patricia Wilson Smoot, J. Patricia Wilson Smoot, Chairperson, U.S. Parole Commission. Chairperson, U.S. Parole Commission. [FR Doc. 2018–08143 Filed 4–13–18; 4:15 pm] [FR Doc. 2018–08144 Filed 4–13–18; 4:15 pm] BILLING CODE 4410–31–P BILLING CODE 4410–31–P

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NATIONAL SCIENCE FOUNDATION supports an integrated, interdisciplinary binding between the academic research environment to advance institution and the NSF. Notice of Intent To Seek Approval To fundamental engineering knowledge Each Center’s annual report will Renew an Information Collection and engineered systems; educate a address the following categories of globally competitive and diverse activities: (1) Vision and impact, (2) AGENCY: National Science Foundation. engineering workforce from K–12 on; strategic plan, (3) research program, (4) ACTION: Notice and request for and join academe and industry in innovation ecosystem and industrial comments. partnership to achieve these goals. ERCs collaboration, (5) education, (6) SUMMARY: Under the Paperwork conduct world-class research through infrastructure (leadership, management, Reduction Act of 1995, and as part of its partnerships of academic institutions, facilities, diversity) and (7) budget continuing effort to reduce paperwork national laboratories, industrial issues. and respondent burden, the National organizations, and/or other public/ For each of the categories the report Science Foundation (NSF) is inviting private entities. New knowledge thus will describe overall objectives for the the general public or other Federal created is meaningfully linked to year, progress toward center goals, agencies to comment on this proposed society. problems the Center has encountered in ERCs conduct world-class research continuing information collection. NSF making progress towards goals and how with an engineered systems perspective will publish periodic summaries of the they were overcome, plans for the future that integrates materials, devices, proposed projects. and anticipated research and other processes, components, control barriers to overcome in the following DATES: Written comments on this notice algorithms and/or other enabling year, and specific outputs and must be received by June 18, 2018, to be elements to perform a well-defined outcomes. assured consideration. Comments function. These systems provide a Use of the Information: The data received after that date will be unique academic research and collected will be used for NSF internal considered to the extent practicable. education experience that involves reports, historical data, performance Send comments to address below. integrative complexity and review by peer site visit teams, program FOR FURTHER INFORMATION CONTACT: technological realization. The level studies and evaluations, and for Suzanne H. Plimpton, Reports Clearance complexity of the systems perspective securing future funding for continued Officer, National Science Foundation, includes the factors associated with its ERC program maintenance and growth. 2415 Eisenhower Avenue, Alexandria, use in industry, society/environment, or Estimate of Burden: 150 hours per Virginia 22314; telephone (703) 292– the human body. center for 17 centers for a total of 2,550 7556; or send email to splimpto@ ERCs enable and foster excellent hours. nsf.gov. Individuals who use a education, integrate research and Respondents: Academic institutions. telecommunications device for the deaf education, speed knowledge/technology Estimated Number of Responses per (TDD) may call the Federal Information transfer through partnerships between Report: One from each of the 17 ERCs. Relay Service (FIRS) at 1–800–877– academe and industry, and prepare a Dated: April 12, 2018. 8339, which is accessible 24 hours a more competitive future workforce. Suzanne H. Plimpton, day, 7 days a week, 365 days a year ERCs capitalize on diversity through Reports Clearance Officer, National Science (including federal holidays). participation in center activities and Foundation. SUPPLEMENTARY INFORMATION demonstrate leadership in the : [FR Doc. 2018–07983 Filed 4–16–18; 8:45 am] Comments: Comments are invited on: involvement of groups BILLING CODE 7555–01–P (a) Whether the proposed collection of underrepresented in science and information is necessary for the proper engineering. performance of the functions of the Centers are required to submit annual NUCLEAR REGULATORY Foundation, including whether the reports on progress and plans, which COMMISSION information will have practical utility; will be used as a basis for performance review and determining the level of (b) the accuracy of the Foundation’s Advisory Committee on Reactor estimate of the burden of the proposed continued funding. To support this review and the management of a Center, Safeguards (ACRS); Meeting of the collection of information; (c) ways to ACRS Subcommittee on Reliability and enhance the quality, utility, and clarity ERCs also are required to submit management and performance Probabilistic Risk Assessment; Notice of the information to be collected; and of Meeting (d) ways to minimize the burden of the indicators annually to NSF via a data collection of information on those who collection website that is managed by a The ACRS Subcommittee on are to respond, including through the technical assistance contractor. These Reliability and Probabilistic Risk use of automated collection techniques indicators are both quantitative and Assessment will hold a meeting on May or other forms of information descriptive and may include, for 2, 2018 at 11545 Rockville Pike, Room technology. example, the characteristics of center T–2B1, Rockville, Maryland 20852. Title of Collection: Grantee Reporting personnel and students; sources of cash The meeting will be open to public Requirements for the Engineering and in-kind support; expenditures by attendance with the exception of Research Centers (ERCs). operational component; characteristics portions that will be closed to protect OMB Number: 3145–0220. of industrial and/or other sector information that is proprietary pursuant Expiration Date of Approval: June 30, participation; research activities; to 5 U.S.C. 552b(c)(4). The agenda for 2018. education activities; knowledge transfer the subject meeting shall be as follows: Type of Request: Intent to seek activities; patents, licenses; Wednesday, May 2, 2018—8:30 a.m. approval to renew an information publications; degrees granted to Until 5:00 p.m. collection. students involved in Center activities; descriptions of significant advances and The Subcommittee will hear Abstract other outcomes of the ERC effort. Such presentations by and hold discussions Proposed Project: The Engineering reporting requirements will be included with the NRC staff and other interested Research Centers (ERC) program in the cooperative agreement which is persons on the progress of the Level 3

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Probabilistic Risk Assessment Project. NUCLEAR REGULATORY Rockville, Maryland 20852. After The Subcommittee will gather COMMISSION registering with Security, please contact information, analyze relevant issues and Mr. Theron Brown at 301–415–6702 to facts, and formulate proposed positions Advisory Committee on Reactor be escorted to the meeting room. Safeguards (ACRS); Meeting of the and actions, as appropriate, for Dated: April 11, 2018. deliberation by the Full Committee. ACRS Subcommittee on Planning and Procedures; Notice of Meeting Mark L. Banks, Members of the public desiring to Chief, Technical Support Branch, Advisory provide oral statements and/or written The ACRS Subcommittee on Planning Committee on Reactor Safeguards. comments should notify the Designated and Procedures will hold a meeting on [FR Doc. 2018–07937 Filed 4–16–18; 8:45 am] Federal Official (DFO), Christiana Lui May 2, 2018, 11545 Rockville Pike, BILLING CODE 7590–01–P (Telephone 301–415–2492 or Email Room T–2B3, Rockville, Maryland [email protected]) five days prior 20852. to the meeting, if possible, so that The meeting will be open to public appropriate arrangements can be made. attendance. SECURITIES AND EXCHANGE Thirty-five hard copies of each The agenda for the subject meeting COMMISSION presentation or handout should be shall be as follows: Sunshine Act Meetings provided to the DFO thirty minutes Wednesday, May 2, 2018—12:00 p.m. before the meeting. In addition, one until 1:00 p.m. electronic copy of each presentation TIME AND DATE: 2:30 p.m. on Thursday, should be emailed to the DFO one day The Subcommittee will discuss April 19, 2018. before the meeting. If an electronic copy proposed ACRS activities and related PLACE: Closed Commission Hearing, cannot be provided within this matters. The Subcommittee will gather Room 10800. timeframe, presenters should provide information, analyze relevant issues and STATUS: This meeting will be closed to the DFO with a CD containing each facts, and formulate proposed positions the public. presentation at least thirty minutes and actions, as appropriate, for deliberation by the Full Committee. MATTERS TO BE CONSIDERED: before the meeting. Electronic Commissioners, Counsel to the recordings will be permitted only Members of the public desiring to provide oral statements and/or written Commissioners, the Secretary to the during those portions of the meeting Commission, and recording secretaries that are open to the public. Detailed comments should notify the Designated Federal Official (DFO), Quynh Nguyen will attend the closed meeting. Certain procedures for the conduct of and staff members who have an interest in participation in ACRS meetings were (Telephone 301–415–5844 or Email: [email protected]) five days prior the matters also may be present. published in the Federal Register on The General Counsel of the October 4, 2017 (82 FR 46312). to the meeting, if possible, so that arrangements can be made. Thirty-five Commission, or his designee, has Detailed meeting agendas and meeting hard copies of each presentation or certified that, in his opinion, one or transcripts are available on the NRC handout should be provided to the DFO more of the exemptions set forth in 5 website at http://www.nrc.gov/reading- thirty minutes before the meeting. In U.S.C. 552b(c)(3), (5), (6), (7), (8), 9(B) rm/doc-collections/acrs. Information addition, one electronic copy of each and (10) and 17 CFR 200.402(a)(3), regarding topics to be discussed, presentation should be emailed to the (a)(5), (a)(6), (a)(7), (a)(8), (a)(9)(ii) and changes to the agenda, whether the DFO one day before the meeting. If an (a)(10), permit consideration of the meeting has been canceled or electronic copy cannot be provided scheduled matters at the closed meeting. rescheduled, and the time allotted to within this timeframe, presenters Commissioner Jackson, as duty present oral statements can be obtained should provide the DFO with a CD officer, voted to consider the items from the website cited above or by containing each presentation at least listed for the closed meeting in closed contacting the identified DFO. thirty minutes before the meeting. session. Moreover, in view of the possibility that Electronic recordings will be permitted The subject matters of the closed the schedule for ACRS meetings may be only during those portions of the meeting will be: adjusted by the Chairman as necessary meeting that are open to the public. Institution of injunctive actions; to facilitate the conduct of the meeting, Detailed procedures for the conduct of Institution and settlement of persons planning to attend should check and participation in ACRS meetings administrative proceedings; with these references if such were published in the Federal Register Litigation matter; and rescheduling would result in a major on October 4, 2017 (82 FR 46312). Other matters relating to enforcement inconvenience. Information regarding changes to the proceedings. If attending this meeting, please enter agenda, whether the meeting has been At times, changes in Commission through the One White Flint North canceled or rescheduled, and the time priorities require alterations in the building, 11555 Rockville Pike, allotted to present oral statements can scheduling of meeting items. Rockville, Maryland 20852. After be obtained by contacting the identified CONTACT PERSON FOR MORE INFORMATION: registering with Security, please contact DFO. Moreover, in view of the For further information and to ascertain Mr. Theron Brown (Telephone 301– possibility that the schedule for ACRS what, if any, matters have been added, 415–6702) to be escorted to the meeting meetings may be adjusted by the deleted or postponed; please contact room. Chairman as necessary to facilitate the Brent J. Fields from the Office of the conduct of the meeting, persons Dated: April 11, 2018. Secretary at (202) 551–5400. planning to attend should check with Mark L. Banks, the DFO if such rescheduling would Dated: April 12, 2018. Chief, Technical Support Branch, Advisory result in a major inconvenience. Brent J. Fields, Committee on Reactor Safeguards. If attending this meeting, please enter Secretary. [FR Doc. 2018–07938 Filed 4–16–18; 8:45 am] through the One White Flint North [FR Doc. 2018–08083 Filed 4–13–18; 11:15 am] BILLING CODE 7590–01–P building, 11555 Rockville Pike, BILLING CODE 8011–01–P

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SECURITIES AND EXCHANGE regarding the proposed rule change. higher than the Maximum Value 12 or COMMISSION This order approves the proposed rule lower than the Minimum Value 13 will change, as modified by Amendment be cancelled. A box spread entered as a [Release No. 34–83033; File No. SR–Phlx– 2018–14) Nos. 1, 2, and 3. market order will be accepted but will be restricted from trading at a price that II. Description of the Proposed Rule Self-Regulatory Organizations; Nasdaq is higher than the Maximum Value or Change, as Modified by Amendment 14 PHLX LLC; Order Approving a Nos. 1, 2, and 3 lower than the Minimum Value. The Proposed Rule Change, as Modified by Butterfly Spread Protection and the Box Amendment Nos. 1, 2, and 3, To Adopt As described more fully in the Notice, Spread Protection apply to orders being Protections for Butterfly Spreads and the Exchange proposes to amend Phlx auctioned and to auction responses, and Box Spreads Rule 1098 to adopt protections that will they apply throughout the trading day, prevent the execution of a butterfly including during the pre-market, the April 11, 2018. spread 6 or a box spread 7 at a price opening process, and trading halts.15 outside of specified minimum and I. Introduction The Phlx states that the proposal is maximum values (the ‘‘Butterfly Spread responsive to member input and will On February 9, 2018, Nasdaq PHLX Protection’’ and the ‘‘Box Spread provide members with additional LLC (‘‘Phlx’’ or the ‘‘Exchange’’) filed 8 Protection,’’ respectively). Under the functionality that will assist them in with the Securities and Exchange Butterfly Spread Protection, a butterfly managing risk.16 In addition, the Phlx Commission (‘‘Commission’’), pursuant spread that is priced higher than the states that the buffer allowance from the to Section 19(b)(1) of the Securities 9 Maximum Value or lower than the minimum and maximum values Exchange Act of 1934 (‘‘Act’’) 1 and Rule 10 Minimum Value will be cancelled. A permitted for the execution of butterfly 19b–4 thereunder,2 a proposed rule butterfly spread entered as a market and box spreads will provide market change to amend Phlx Rule 1098, order will be accepted but will be participants with flexibility to manage ‘‘Complex Orders on the System,’’ to restricted from trading at a price that is their business.17 adopt protections for Complex Orders The Phlx notes that it higher than the Maximum Value or currently offers similar order protection that are box spreads or butterfly 11 lower than the Minimum Value. features for Complex Orders to avoid spreads.3 On February 21, 2018, the Similarly, under the Box Spread erroneous trades, including the Strategy Exchange filed Amendment No. 1 to the Protection, a box spread that is priced Price Protection and the Acceptable proposed rule change, which Complex Execution (‘‘ACE’’) superseded the original filing in its 6 A butterfly spread is a three legged Complex Parameter.18 entirety. The proposed rule change, as Order with the following: (1) Two legs to buy (sell) modified by Amendment No. 1, was the same number of calls (puts); (2) one leg to sell (buy) twice the number of calls (puts) with a strike III. Discussion and Commission published for comment in the Federal price at mid-point of the two legs to buy (sell); (3) Findings Register on March 1, 2018.4 On April 9, all legs have the same expiration; and (4) each leg After careful review, the Commission 2018, the Exchange filed Amendment strike price is equidistant from the next sequential finds that the proposed rule change is No. 2 to the proposal. On April 10, strike price. See proposed Phlx Rule 1098(i). 7 A box spread is a four legged Complex Order consistent with the requirements of the 2018, the Exchange filed Amendment with the following: (1) One pair of legs with the Act and the rules and regulations No. 3 to the proposal, which superseded same strike price with one leg to buy a call (put) thereunder applicable to a national Amendment No. 2 in its entirety.5 The and one leg to sell a put (call); (2) a second pair securities exchange.19 In particular, the Commission received no comments of legs with a different strike price from the pair described in (1) with one leg to sell a call (put) and Commission finds that the proposed one leg to buy a put (call); (3) all legs have the same 1 rule change is consistent with Section 15 U.S.C. 78s(b)(1). expiration; and (4) all legs have equal volume. See 20 2 17 CFR 240.19b–4. proposed Phlx Rule 1098(j). 6(b)(5) of the Act, which requires, 3 For purposes of the electronic trading of 8 See Notice, 83 FR at 8915. among other things, that the rules of a Complex Orders, a ‘‘Complex Order’’ is an order 9 For a butterfly spread, the Maximum Value is national securities exchange be involving the simultaneous purchase and/or sale of calculated by adding the Initial Maximum Value two or more different options series in the same (the distance between strike price of the leg with 12 For a box spread, the Maximum Value is underlying security, priced as a net debit or credit the mid-point strike and either of the outer leg calculated by adding the Initial Maximum Value based on the relative prices of the individual strike prices) and the Maximum Value Buffer. The (the distance between the strike prices of each pair components, for the same account, for the purpose Maximum Value Buffer is the lesser of a of leg strike prices) and the Maximum Value Buffer. of executing a particular investment strategy. See configurable absolute dollar value or percentage of The Maximum Value Buffer is the lesser of a Phlx Rule 1098(a)(i). the Initial Maximum Value set by the Exchange and configurable absolute dollar value or percentage of 4 See Securities Exchange Act Release No. 82766 announced via a notice to members. See proposed the Initial Maximum value set by the Exchange and (February 23, 2018), 83 FR 8914 (March 1, 2018) Phlx Rule 1098(i)(i)(a). announced via a notice to members. See proposed (‘‘Notice’’). 10 For a butterfly spread, the Minimum Value is Phlx Rule 1098(j)(i)(a). 5 In Amendment No. 3, the Phlx revised the calculated by subtracting the Minimum Value 13 For a box spread, the Minimum Value is proposal to (1) replace references in proposed Phlx Buffer (a configurable absolute dollar value set by calculated by subtracting the Minimum Value Rule 1098(i)(i) to ‘‘Complex Order’’ with ‘‘Butterfly the Exchange and announced via a notice to Buffer (a configurable absolute dollar value set by Spread,’’ and to ‘‘Complex Market Order’’ with members) from the Initial Minimum Value of zero. the Exchange and announced via a notice to ‘‘Butterfly Spread entered as a Market Order;’’ (2) See proposed Phlx Rule 1098(i)(i)(b). The Phlx members) from the Initial Minimum Value of zero. revise proposed Phlx Rule 1098(i)(i)(a) to indicate notes that the Minimum Value could be less than See proposed Phlx Rule 1098(j)(i)(b). that the Initial Maximum Value is the distance zero. See Notice, 83 FR at 8915. The Phlx states that 14 See proposed Phlx Rule 1098(j)(i). a market participant seeking to trade out of a between the strike price of the leg with the mid- 15 See proposed Phlx Rules 1098(i)(i) and (ii), and position at intrinsic value might not find a contra- point and either of the outer leg strike prices; (3) 1098(j)(i) and (ii). replace references in proposed Phlx Rule 1098(j)(i) side willing to trade without a premium. The Phlx 16 See Notice, 83 FR at 8916. to ‘‘Complex Order’’ with ‘‘Box Spread’’ and to notes that an incremental allowance outside of the 17 ‘‘Complex Market Order’’ with ‘‘Box Spread entered minimum/maximum value would allow for a small See id. at 8917. as a Market Order;’’ (4) amend proposed Phlx Rules premium to offset commissions associated with 18 See id. at 8915. See also Phlx Rules 1098(g) 1098(i)(i) and (j)(i) to refer to ‘‘an order being trading and could incentivize participants to take (Strategy Price Protection) and 1098(h)(i) (ACE auctioned,’’ rather than an ‘‘auction;’’ and (5) delete the other side of a spread trading at intrinsic value. Parameter). the reference to ‘‘spread’’ in proposed Phlx Rule The Phlx further notes that a participant might find 19 In approving this proposed rule change, the 1098(j)(i)(b). Because Amendment No. 3 makes only it financially beneficial to pay a small premium to Commission has considered the proposed rule’s clarifying and technical changes, and does not close out its position rather than carry the position impact on efficiency, competition, and capital present unique or novel regulatory issues, it is not to expiration and take delivery. See id. formation. See 15 U.S.C. 78c(f). subject to notice and comment. 11 See proposed Phlx Rule 1098(i)(i). 20 15 U.S.C. 78f(b)(5).

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designed to prevent fraudulent and the Office of Management and Budget Rule 6e–2 and Form N–6EI–1, SEC File No. manipulative acts and practices, to (‘‘OMB’’) for extension and approval. 270–177, OMB Control No. 3235–0177 promote just and equitable principles of Rule 15g–4 requires brokers and Notice is hereby given that, pursuant dealers effecting transactions in penny trade, to remove impediments to and to the Paperwork Reduction Act of 1995 stocks for or with customers to disclose perfect the mechanism of a free and (44 U.S.C. 3501 et seq.), the Securities the amount of compensation received by open market and a national market and Exchange Commission the broker-dealer in connection with the system and, in general, to protect (‘‘Commission’’) has submitted to the transaction. The purpose of the rule is investors and the public interest. Office of Management and Budget a to increase the level of disclosure to The Commission believes that the request for extension of the previously investors concerning penny stocks Butterfly Spread Protection and the Box approved collection of information generally and specific penny stock Spread Protection will help market discussed below. participants mitigate risk by preventing transactions. the execution of butterfly and box The Commission estimates that Rule 6e–2 (17 CFR 270.6e–2) under spreads at prices that are outside of approximately 195 broker-dealers will the Investment Company Act of 1940 specified minimum and maximum spend an average of 87 hours annually (‘‘Act’’) (15 U.S.C. 80a) is an exemptive values. The Commission notes that the to comply with this rule. Thus, the total rule that provides separate accounts Phlx has indicated that the protections compliance burden is approximately formed by life insurance companies to are responsive to input from Phlx 16,965 burden-hours per year. fund certain variable life insurance members.21 In addition, the Written comments are invited on: (a) products, exemptions from certain Commission notes that another options Whether the proposed collection of provisions of the Act, subject to exchange has adopted similar price information is necessary for the proper conditions set forth in the rule. protections.22 performance of the functions of the Rule 6e–2 provides a separate account agency, including whether the with an exemption from the registration IV. Conclusion information shall have practical utility; provisions of section 8(a) of the Act if It is therefore ordered, pursuant to (b) the accuracy of the agency’s the account files with the Commission Section 19(b)(2) of the Act,23 that the estimates of the burden of the proposed Form N–6EI–1 (17 CFR 274.301), a proposed rule change (SR–Phlx–2018– collection of information; (c) ways to notification of claim of exemption. 14), as modified by Amendment Nos. 1, enhance the quality, utility, and clarity The rule also exempts a separate 2, and 3, is approved. of the information to be collected; and account from a number of other sections (d) ways to minimize the burden of the For the Commission, by the Division of of the Act, provided that the separate Trading and Markets, pursuant to delegated collection of information on account makes certain disclosure in its authority.24 respondents, including through the use registration statements (in the case of Eduardo A. Aleman, of automated collection techniques or those separate account that elect to other forms of information technology. Assistant Secretary. register), reports to contract holders, Consideration will be given to proxy solicitations, and submissions to [FR Doc. 2018–07932 Filed 4–16–18; 8:45 am] comments and suggestions submitted in BILLING CODE 8011–01–P state regulatory authorities, as writing within 60 days of this prescribed by the rule. publication. An agency may not conduct or Since 2008, there have been no filings SECURITIES AND EXCHANGE sponsor, and a person is not required to of Form N–6EI–1 by separate accounts. COMMISSION respond to, a collection of information Therefore, there has been no cost or under the PRA unless it displays a burden to the industry since that time. Proposed Collection; Comment currently valid OMB control number. The Commission requests authorization Request Please direct your written comments to maintain an inventory of one burden Upon Written Request, Copies Available to: Pamela Dyson, Acting Director/Chief hour for administrative purposes. From: Securities and Exchange Information Officer, Securities and An agency may not conduct or Commission, Office of FOIA Services, Exchange Commission, c/o Remi Pavlik- sponsor, and a person is not required to Washington, DC 20549–2736 Simon, 100 F Street NE, Washington, respond to, a collection of information DC 20549 or send an email to PRA_ unless it displays a currently valid Extension: control number. Rule 15g–4, SEC File No. 270–347, OMB [email protected]. Control No. 3235–0393 Dated: April 11, 2018. The public may view the background Eduardo A. Aleman, documentation for this information Notice is hereby given that pursuant collection at the following website, Assistant Secretary. to the Paperwork Reduction Act of 1995 www.reginfo.gov. Comments should be (‘‘PRA’’) (44 U.S.C. 3501 et seq.), the [FR Doc. 2018–07961 Filed 4–16–18; 8:45 am] directed to: (i) Desk Officer for the Securities and Exchange Commission BILLING CODE 8011–01–P Securities and Exchange Commission, (‘‘Commission’’) is soliciting comments Office of Information and Regulatory on the existing collection of information Affairs, Office of Management and provided for in Rule 15g–4—Disclosure SECURITIES AND EXCHANGE COMMISSION Budget, Room 10102, New Executive of compensation to brokers or dealers Office Building, Washington, DC 20503, (17 CRF 240.15g–4) under the Securities or by sending an email to: Shagufta_ Exchange Act of 1934 (15 U.S.C. 78a et Submission for OMB Review; Comment Request [email protected]; and (ii) Pamela seq.). The Commission plans to submit Dyson, Director/Chief Information this existing collection of information to Upon Written Request, Copies Available Officer, Securities and Exchange From: Securities and Exchange Commission, c/o Remi Pavlik-Simon, 21 See Notice, 83 FR at 8916. Commission, Office of FOIA Services, 22 100 F Street NE, Washington, DC 20549 See CBOE Rule 6.53C, Interpretation and Policy 100 F Street NE, Washington, DC _ .08(g). or send an email to: PRA Mailbox@ 23 15 U.S.C. 78s(b)(2). 20549–2736 sec.gov. Comments must be submitted to 24 17 CFR 200.30–3(a)(12). Extension: OMB within 30 days of this notice.

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Dated: April 11, 2018. II. Self-Regulatory Organization’s Holder’s or Market Maker’s providing Eduardo A. Aleman, Statement of the Purpose of, and average daily volume in July 2016, and Assistant Secretary. Statutory Basis for, the Proposed Rule (ii) sets a new NYSE Arca Best Bid or Change [FR Doc. 2018–07960 Filed 4–16–18; 8:45 am] Offer with at least 25% in each of the ETP Holder’s or Market Maker’s Tape A, BILLING CODE 8011–01–P In its filing with the Commission, the self-regulatory organization included Tape B and Tape C providing ADV. ETP statements concerning the purpose of, Holders and Market Makers can SECURITIES AND EXCHANGE and basis for, the proposed rule change alternatively qualify for the Step-Up COMMISSION and discussed any comments it received Tier if such ETP Holder or Market on the proposed rule change. The text Maker, on a daily basis, measured of those statements may be examined at monthly: (i) Directly execute providing [Release No. 34–83032; File No. SR– the places specified in Item IV below. average daily volume that is an increase NYSEArca–2018–20] The Exchange has prepared summaries, of no less than 0.15% of US CADV for Self-Regulatory Organizations; NYSE set forth in sections A, B, and C below, that month over the ETP Holder’s or Market Maker’s providing average daily Arca, Inc.; Notice of Filing and of the most significant parts of such statements. volume in July 2016, and (ii) sets a new Immediate Effectiveness of Proposed NYSE Arca Best Bid or Offer with at Rule Change To Amend the NYSE Arca A. Self-Regulatory Organization’s least 20% in the ETP Holder’s or Market Equities Fees and Charges Statement of the Purpose of, and Maker’s Tape A providing ADV, at least Statutory Basis for, the Proposed Rule April 11, 2018. Change 25% in the ETP Holder’s or Market Maker’s Tape B providing ADV, and at 1 Pursuant to Section 19(b)(1) of the 1. Purpose least 30% in the ETP Holder’s or Market Securities Exchange Act of 1934 (the The Exchange proposes to amend the Maker’s Tape C providing ADV, and (iii) ‘‘Act’’) 2 and Rule 19b–4 thereunder, 3 Fee Schedule, as described below, to (i) directly execute taking average daily notice is hereby given that, on March revise the requirements for the Step-Up volume of at least 15 million shares. 30, 2018, NYSE Arca, Inc. (the Tier; (ii) adopt a new pricing tier, BBO ETP Holders and Market Makers that ‘‘Exchange’’ or ‘‘NYSE Arca’’) filed with Setter Tier; (iii) delete the Tape A and qualify for the Step-Up Tier receive a the Securities and Exchange Tape C Tier; (iv) eliminate the credits credit of $0.0029 per share for orders Commission (the ‘‘Commission’’) the associated with IOIs; (v) delete obsolete that provide liquidity to the Book in proposed rule change as described in language related to an ETP Incentive Tape A and Tape C Securities and Items I, II, and III below, which Items Program; and (vi) modify the credit the $0.0028 per share for orders that have been prepared by the self- Exchange provides for orders with the provide liquidity to the Book in Tape B regulatory organization. The STPC and STPD Modifiers. The Securities. Commission is publishing this notice to Exchange proposes to implement the fee The Step-Up Tier has not encouraged solicit comments on the proposed rule changes on April 2, 2018. ETP Holders and Market Makers to change from interested persons. Step-Up Tier increase their activity to qualify for this I. Self-Regulatory Organization’s In September 2016, the Exchange filed pricing tier as significantly as the Statement of the Terms of the Substance a proposed rule change to adopt a new Exchange had anticipated that it would. of the Proposed Rule Change Step-Up pricing tier that was intended As a result, the Exchange proposes to to incentivize ETP Holders and Market revise the current requirements to The Exchange proposes to amend the Makers to increase order flow and qualify for the Step-Up Tier. As NYSE Arca Equities Fees and Charges provide additional liquidity.4 In proposed, ETP Holders and Market (‘‘Fee Schedule’’) to (i) revise the September 2017, the Exchange filed a Makers would qualify for the Step-Up requirements to qualify for the Step-Up proposed rule change to adopt a second Tier if they directly execute providing Tier; (ii) adopt a new pricing tier, BBO way by which an ETP Holder or Market average daily volume per month of Setter Tier; (iii) delete the Tape A and Maker could qualify for the Step-Up 0.50% or more but less than 0.70% of Tape C Tier; (iv) eliminate the credits Tier.5 Currently, to qualify for the Step- the US CADV, and directly execute associated with indications of interest Up Tier, ETP Holders and Market providing ADV that is an increase of no (‘‘IOIs’’); (v) delete obsolete language Makers, on a daily basis, measured less than 0.10% of US CADV for that related to an Exchange Traded Product monthly must: (i) directly execute month over the ETP Holder’s or Market (‘‘ETP’’) Incentive Program; and (vi) providing average daily volume that is Maker’s providing ADV in Q1 2018. ETP modify the credit the Exchange provides an increase of no less than 0.15% of US Holders and Market Makers that qualify for orders with the Self Trade CADV 6 for that month over the ETP for the Step-Up Tier would receive a Prevention (‘‘STP’’) Cancel Both credit of $0.0030 per share for orders (‘‘STPC’’) and STP Decrement and 4 See Securities Exchange Act Release No. 78892 that provide displayed liquidity to the Cancel (‘‘STPD’’) Modifiers. The (September 21, 2016), 81 FR 66315 (September 27, Book in Tape A Securities, $0.0023 per 2016) (SR–NYSEArca–2016–128). Exchange proposes to implement the fee share for orders that provide displayed 5 See Securities Exchange Act Release No. 81601 liquidity to the Book in Tape B changes effective April 2, 2018. The (September 13, 2017), 82 FR 43633 (September 18, Securities, and $0.0031 per share for proposed rule change is available on the 2017) (SR–NYSEArca–2017–104). orders that provide displayed liquidity Exchange’s website at www.nyse.com, at 6 US CADV means United States Consolidated Average Daily Volume for transactions reported to in Tape C Securities. the principal office of the Exchange, and the Consolidated Tape, excluding odd lots through at the Commission’s Public Reference January 31, 2014 (except for purposes of Lead The goal of the Step-Up Tier remains Room. Market Maker pricing), and excludes volume on the same, i.e., to incentivize ETP days when the market closes early and on the date Holders and Market Makers to increase of the annual reconstitution of the Russell the orders sent directly to NYSE Arca 1 15 U.S.C. 78s(b)(1). Investments Indexes. Transactions that are not and therefore provide liquidity that 2 15 U.S.C. 78a. reported to the Consolidated Tape are not included 3 17 CFR 240.19b–4. in US CADV. supports the quality of price discovery

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and promotes market transparency.7 BBO Setter Tier, which would provide elimination of the credits by adopting The Exchange believes that the an additional credit of $0.0004 per share rule text on the Fee Schedule that proposed new qualifying requirement to the qualifying ETP ID, and combined would replace the current tiered credits for the Step-Up Tier will provide an with the ETP Holder or Market Maker’s with ‘‘No Credit.’’ incentive for ETP Holders or Market credit of $0.0033 per share, the ETP Makers that are active traders on the Holder or Market Maker in this example ETP Incentive Program would receive a total credit of $0.0037 Exchange to increase the orders sent to The Exchange proposes to amend the per share for orders that set a new NYSE the Exchange that would provide Fee Schedule to reflect the termination Arca BBO. The ETP ID’s orders that do liquidity. of a pilot program designed to not set a new NYSE Arca BBO would BBO Setter Tier not receive the proposed BBO Setter incentivize quoting and trading in The Exchange proposes a new pricing Tier credit. Exchange Traded Products (‘‘ETPs’’) and tier—BBO Setter Tier—for securities to add competition among existing Tape A and Tape C Tier 12 with a per share price of $1.00 or above. qualified Market Makers (‘‘ETP As proposed, a new BBO Setter Tier In July 2017, the Exchange filed a Incentive Program’’). The ETP Incentive credit of $0.0004 per share for orders proposed rule change to adopt a new Program was also designed to enhance that set a new NYSE Arca BBO in Tape pricing tier—Tape A and Tape C Tier— the market quality for ETPs by A and Tape C Securities and $0.0002 as an incentive for ETP Holders and incentivizing Market Makers to take per share for orders that set a new NYSE Market Makers to provide liquidity in Lead Market Maker (‘‘LMM’’) 13 Arca BBO in Tape B Securities would Tape A and Tape C Securities.10 The assignments in certain lower-volume apply to ETP Holders and Market Tape A and Tape C Tier has not ETPs by offering an alternative fee Makers that directly execute providing encouraged ETP Holders and Market structure for such LMMs.14 The ETP ADV per month of 0.70% or more of the Makers to increase their activity to Incentive Program was established in US CADV, and provided that an ETP qualify for this pricing tier as 2013.15 The Exchange subsequently ID 8 associated with an ETP Holder or significantly as the Exchange had filed to extend it in 2014,16 in 2015,17 Market Maker, on a daily basis, anticipated they would. As a result, the and finally in 2016.18 However, the measured monthly (1) Directly executes Exchange proposes to remove this Exchange did not extend the program providing ADV of at least 0.20% of US pricing tier from the Fee Schedule. and it expired on July 31, 2017. The CADV, (2) sets a new NYSE Arca BBO IOI Credit Exchange proposes to remove reference with at least 0.10% of US CADV; and (3) to the ETP Incentive Program from the In August 2008, the Exchange filed a sets a new NYSE Arca BBO of at least proposed rule change to adopt credits Fee Schedule. 40% of that ETP Holder’s or Market that apply to indications of interest STP Modifier Maker’s ETP ID providing ADV. The (‘‘IOIs’’) submitted by ETP Holders that proposed credit would be in addition to result in routed and executed orders.11 The Exchange currently provides STP the ETP Holder’s or Market Maker’s IOIs are non-displayed indications of Modifiers that allow ETP Holders Tiered or Basic Rate credit(s), and for symbol, size and side, which do not entering orders to elect to prevent those Tape B and Tape C Securities, the interact with the NYSE Arca Book. At orders from executing against other proposed credit would be in addition to their discretion, participating ETP 9 orders entered on the Exchange by the any capped credit. Holders may send an IOI to the For example, assume an ETP Holder Exchange, which in turn considers the 12 With respect to equities traded on the or Market Maker qualifies for the Tape IOI when determining potential Exchange, the term Market Maker refers to an ETP C Tier 1 credit of $0.0032 per share for destinations for outbound routes. The Holder that acts as a Market Maker pursuant to orders that provide liquidity to the purpose for adopting IOI Credits was to NYSE Arca Rule 7–E. See NYSE Arca Rule 1.1(z). Book. Assume further that the same ETP An ETP Holder is a sole proprietorship, incentivize ETP Holders to participate partnership, corporation, limited liability company, Holder or Market Maker also qualifies in the Exchange’s IOI program and or other organization in good standing that has been for the Tape C Tier 2 incremental credit provide additional liquidity to the issued an ETP. See NYSE Arca Rule 1.1(o). of $0.0002 per share. Pursuant to the marketplace. The IOI Credits have not 13 With respect to equities traded on the Tape C Tier 2 pricing tier, the ETP Exchange, the term Lead Market Maker refers to incentivized ETP Holders to participate registered Market Maker that is the exclusive Holder or Market Maker’s credit cannot in the IOI program as anticipated by the Designated Market Maker in listings for which the exceed $0.0033 per share. In this Exchange. As a result, the Exchange Exchange is the primary listing market. See NYSE example, the ETP Holder or Market proposes to eliminate the credits Arca Rule 1.1(w). Maker’s credit would be capped at associated with IOIs by deleting IOI 14 The LMM program was designed to incentivize $0.0033 per share. Assume further that firms to take on the LMM designation and foster Credit Tier 2 and IOI Credit Tier 3 liquidity provision and stability in the market. In the ETP Holder or Market Maker has an entirely and renaming IOI Credit Tier 1 order to accomplish this, the Exchange provided ETP ID that qualifies for the proposed as IOI Credit. With this proposed rule LMMs with an opportunity to receive incrementally change, the Exchange would no longer higher transaction credits and incur incrementally 7 lower transaction fees compared to standard See supra, note 5, at 43634. provide credits associated with IOIs. 8 ETP Holders enter orders and order instructions liquidity maker-taker rates. by using communication protocols that map to the The Exchange proposes to reflect the 15 See Securities Exchange Act Release No. 69706 order types and modifiers described in Exchange (June 6, 2013), 78 FR 35340 (June 12, 2013) (SR– rules. The Exchange makes available ports that 10 See Securities Exchange Act Release No. 81134 NYSEArca–2013–34) (‘‘ETP Incentive Program communicate with the Exchange using Pillar phase (July 12, 2017), 82 FR 32911 (July 18, 2017) (SR– Approval’’). I protocols and Pillar phase II protocols. For NYSEArca–2017–72). 16 See Securities Exchange Act Release No. 72963 purposes of the BBO Setter Tier, references to ETP 11 See Securities Exchange Act Release Nos. (September 3, 2014), 79 FR 53492 (September 9, ID means an ETP ID when using Pillar phase I 58397 (August 20, 2008), 73 FR 50389 (August 26, 2014) (SR–NYSEArca–2014–99). protocols to communicate with the NYSE Arca 2008) (SR–NYSEArca–2008–83); 59521 (March 5, 17 See Securities Exchange Act Release No. 75846 Marketplace or an MPID when using Pillar phase 2009), 74 FR 10640 (March 11, 2009) (SR– (September 4, 2015), 80 FR 54646 (September 10, II protocols to communicate with the NYSE Arca NYSEArca–2009–15); 60495 (August 13, 2009), 74 2015) (SR–NYSEArca–2015–78). Marketplace. FR 41957 (August 19, 2009) (SR–NYSEArca–2009– 18 See Securities Exchange Act Release No. 78497 9 The Exchange does not have any capped credits 72); and 66379 (February 10, 2012), 77 FR 9277 (August 8, 2016), 81 FR 53524 (August 12, 2016) for trading in Tape A Securities. (February 16, 2012) (SR–NYSEArca–2012–11). (SR–NYSEArca–2016–110).

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same ETP Holder.19 In connection with facilities and does not unfairly which would benefit all investors by the STP functionality, the Exchange discriminate between customers, deepening the Exchange’s liquidity adopted credits and fees for orders issuers, brokers or dealers. pool, improving displayed prices and returned to an ETP Holder using the The Exchange believes that the promoting market transparency. The STP Modifiers.20 Currently, ETP proposed revised Step-Up Tier is Exchange believes the proposed pricing Holders entering an incoming order equitable because it is open to all ETP tier is equitable and not unfairly with either the STP Cancel Both Holders and Market Makers on an equal discriminatory because the per share (‘‘STPC’’) or the STP Decrement and basis and provides credits that are credit(s) under the BBO Setter Tier Cancel (‘‘STPD’’) Modifier are charged reasonably related to the value to an would be available to all ETP Holders’ $0.0030 per share for orders returned to exchange’s market quality associated and Market Makers’ ETP IDs on an equal the ETP Holder. The ETP Holder’s with higher volumes. As stated above, basis and provides an incremental credit corresponding resting order marked the Exchange believes that the Step-Up for activity that improves the with any of the STP Modifiers that Tier is intended to incentivize market Exchange’s market quality through interacts with an incoming STPC or participants to increase the orders sent increased activity and by encouraging STPD Modifier is credited $0.0029 per directly to NYSE Arca and therefore the setting of the BBO. In this regard, share for orders returned to the ETP provide liquidity that supports the the BBO Setter Tier is intended to Holder. The Exchange proposes to quality of price discovery and promotes encourage higher levels of liquidity modify the credit from $0.0029 per market transparency. Moreover, the provision into the price discovery share to $0.0030 per share for an ETP addition of the Step-Up Tier would process and is consistent with the Holder’s resting order that is returned to benefit market participants whose overall goals of enhancing market the ETP Holder. The Exchange is not increased order flow provides quality. proposing any change to the fees and meaningful added levels of liquidity The Exchange believes that it is credits applicable to orders with the thereby contributing to the depth and reasonable to delete obsolete pricing STP Cancel Newest and the STP Cancel market quality on the Exchange. The tiers from the Fee Schedule because ETP Oldest Modifiers. Exchange believes that the proposed Holders and Market Makers have not On incoming orders marked with the change is equitable and not unfairly increased their activity to qualify for the STPD Modifier, both orders are discriminatory because providing Tape A and Tape C Tier as significantly cancelled back to the ETP Holder if the incentives for orders that are executed as the Exchange anticipated they would. orders are equivalent in size. If the on a registered national securities The Exchange believes that it is orders are not equivalent in size, the exchange would contribute to investors’ equitable and not unfairly equivalent size is cancelled back to the confidence in the fairness of their discriminatory to eliminate the Tape A ETP Holder and the larger order is transactions and would benefit all and Tape C Tier because, as proposed, decremented by the size of the smaller investors by deepening the Exchange’s such pricing tier would be eliminated order with the balance remaining on the liquidity pool, supporting the quality of entirely—ETP Holders and Market NYSE Arca Book. For billing purposes, price discovery, promoting market Makers would no longer be able to only the size of the portion of the orders transparency and improving investor qualify for this pricing tier. This aspect cancelled back to the ETP Holder is protection. of the proposed rule change would charged or credited. On incoming orders The Exchange believes that the result in the removal of obsolete text marked with the STPC Modifier, the proposed NBBO Setter Tier is from the Fee Schedule and therefore entire size of both orders is cancelled reasonable because it provides an add greater clarity to the Fee Schedule. back to ETP Holder. However, for billing opportunity for ETP Holders and Market The Exchange believes that it is purposes, incoming orders marked with Makers that qualify to receive an reasonable to eliminate the credits that the STPC Modifier are only charged or incremental per share credit if the ETP apply to IOIs submitted by ETP Holders credited up to the equivalent size of ID associated with an ETP Holder or that result in routed and executed both orders.21 Market Maker meets certain trading orders because the IOI Credits have not 2. Statutory Basis qualifications and establishes the BBO incentivized ETP Holders to participate on the Exchange.24 Thus the credit The Exchange believes that the in the IOI program as anticipated by the provides incentive to members to Exchange. The Exchange believes that it proposed rule change is consistent with provide aggressively priced orders that Section 6(b) of the Act,22 in general, and is equitable and not unfairly improve the market by setting the BBO discriminatory to eliminate the IOI furthers the objectives of Sections on the Exchange. The Exchange believes 6(b)(4) and (5) of the Act,23 in particular, Credits because, as proposed, such that it is reasonable to adopt higher credits would be eliminated entirely— because it provides for the equitable credit to Tape A and Tape C securities allocation of reasonable dues, fees, and ETP Holders would no longer be able to because it desires to improve the market qualify for such credits. other charges among its members, on the Exchange in those securities in issuers and other persons using its The Exchange believes it is equitable, terms of setting the BBO, which is reasonable and not unfairly currently not as robust as price setting 19 See Securities Exchange Act Release No. 60191 discriminatory to remove reference to (June 30, 2009), 74 FR 32660 (July 8, 2009) (SR– in Tape B securities. The Exchange the ETP Pilot from the Fee Schedule NYSEArca–2009–58). further believes that providing a credit because the ETP Pilot expired in July 20 See Securities Exchange Act Release No. 60322 for qualifying orders in Tape C 2017 and deleting rules that no longer (July 16, 2009), 74 FR 36794 (July 24, 2009) (SR– securities beyond the Tape C Tier 2 cap apply will bring clarity to the Fee NYSEArca–2009–68). The incoming order (last is reasonable as it would create an received order) marked with one of the STP Schedule. The Exchange believes the Modifiers controls the billing treatment of both additional incentive for participants to proposed rule change will make the Fee interacting orders marked with STP Modifiers. See quote aggressively on the Exchange, Schedule clearer and eliminate potential Schedule of Fees, Self Trade Prevention Modifiers, investor confusion, thereby removing footnote 6. 24 This is similar to programs currently in place 21 See supra, note 19. on other exchanges. See NBBO Program, Nasdaq impediments to and perfecting the 22 15 U.S.C. 78f(b). Stock Market, at https://www.nasdaqtrader.com/ mechanism of a free and open market 23 15 U.S.C. 78f(b)(4) and (5). Trader.aspx?id=PriceListTrading2. and a national market system, and in

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general, protecting investors and the available at other venues to be more Electronic Comments public interest. favorable. In such an environment, the • The Exchange believes it is reasonable Exchange must continually adjust its Use the Commission’s internet to modify the credit provided to an ETP fees and rebates to remain competitive comment form (http://www.sec.gov/ Holder’s resting STP order that is with other exchanges and to attract rules/sro.shtml); or returned to the ETP Holder. The order flow to the Exchange. Because • Send an email to rule-comments@ Exchange believes standardizing the competitors are free to modify their own sec.gov. Please include File Number SR– fees and credits applicable to orders fees and credits in response, and NYSEArca–2018–20 on the subject line. marked with the STPC and STPD because market participants may readily Modifier would encourage ETP Holders adjust their order routing practices, the Paper Comments to increase their utilization of the STP Exchange believes that the degree to • Send paper comments in triplicate functionality in order to better manage which fee changes in this market may to Brent J. Fields, Secretary, Securities order flow and prevent undesirable or impose any burden on competition is and Exchange Commission, 100 F Street unexpected executions with themselves. extremely limited. As a result of all of NE, Washington, DC 20549–1090. The Exchange further believes the these considerations, the Exchange does proposed increased credit is equitable not believe that the proposed changes All submissions should refer to File and not unfairly discriminatory because will impair the ability of ETP Holders or Number SR–NYSEArca–2018–20. This it would be available to all similarly competing order execution venues to file number should be included on the situated ETP Holders on an equal basis. maintain their competitive standing in subject line if email is used. To help the For the foregoing reasons, the the financial markets. Exchange believes that the proposal is Commission process and review your consistent with the Act. C. Self-Regulatory Organization’s comments more efficiently, please use Statement on Comments on the only one method. The Commission will B. Self-Regulatory Organization’s Proposed Rule Change Received From post all comments on the Commission’s Statement on Burden on Competition Members, Participants, or Others internet website (http://www.sec.gov/ In accordance with Section 6(b)(8) of rules/sro.shtml). Copies of the the Act,25 the Exchange believes that the No written comments were solicited submission, all subsequent proposed rule change would not impose or received with respect to the proposed amendments, all written statements any burden on competition that is not rule change. with respect to the proposed rule necessary or appropriate in furtherance III. Date of Effectiveness of the change that are filed with the of the purposes of the Act. Instead, the Commission, and all written Exchange believes that the proposal to Proposed Rule Change and Timing for Commission Action communications relating to the add new pricing tiers would encourage proposed rule change between the the submission of additional liquidity to The foregoing rule change is effective Commission and any person, other than a public exchange, thereby promoting upon filing pursuant to Section those that may be withheld from the price discovery and transparency and 19(b)(3)(A) 26 of the Act and enhancing order execution public in accordance with the subparagraph (f)(2) of Rule 19b–4 27 provisions of 5 U.S.C. 552, will be opportunities for ETP Holders and thereunder, because it establishes a due, Market Makers. In addition, the removal available for website viewing and fee, or other charge imposed by the printing in the Commission’s Public of pricing tiers and fee credits, and Exchange. deletion of obsolete text from the Fee Reference Room, 100 F Street NE, Schedule would not have any impact on At any time within 60 days of the Washington, DC 20549 on official inter- or intra-market competition filing of such proposed rule change, the business days between the hours of because the proposed change would Commission summarily may 10:00 a.m. and 3:00 p.m. Copies of such result in a streamlined Fee Schedule. temporarily suspend such rule change if filing also will be available for Also, the Exchange believes the it appears to the Commission that such inspection and copying at the principal proposed increased credit for resting action is necessary or appropriate in the office of the Exchange. All comments STP orders returned to an ETP Holder public interest, for the protection of received will be posted without change. would encourage ETP Holders to investors, or otherwise in furtherance of Persons submitting comments are increase their utilization of the STP the purposes of the Act. If the cautioned that we do not redact or edit Commission takes such action, the functionality in order to better manage personal identifying information from order flow and prevent undesirable or Commission shall institute proceedings 28 comment submissions. You should unexpected executions with themselves under Section 19(b)(2)(B) of the Act to determine whether the proposed rule submit only information that you wish and thus would enhance order to make available publicly. All execution opportunities for ETP change should be approved or disapproved. submissions should refer to File Holders. The Exchange believes that this Number SR–NYSEArca–2018–20, and could promote competition between the IV. Solicitation of Comments should be submitted on or before May Exchange and other execution venues, 8, 2018. including those that currently offer Interested persons are invited to similar STP functionality and submit written data, views, and For the Commission, by the Division of comparable transaction pricing. arguments concerning the foregoing, Trading and Markets, pursuant to delegated The Exchange notes that it operates in including whether the proposed rule authority.29 a highly competitive market in which change is consistent with the Act. Eduardo A. Aleman, market participants can readily favor Comments may be submitted by any of Assistant Secretary. competing venues if they deem fee the following methods: [FR Doc. 2018–07931 Filed 4–16–18; 8:45 am] levels at a particular venue to be BILLING CODE 8011–01–P excessive or rebate opportunities 26 15 U.S.C. 78s(b)(3)(A). 27 17 CFR 240.19b–4(f)(2). 25 15 U.S.C. 78f(b)(8). 28 15 U.S.C. 78s(b)(2)(B). 29 17 CFR 200.30–3(a)(12).

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SURFACE TRANSPORTATION BOARD Transportation Board, 395 E Street SW, C. Approval of Minutes from 87th Washington, DC 20423–0001. In Meeting of SC–147 [Docket No. FD 36172] addition, a copy must be served on John D. Approval of Agenda JP Rail, Inc. d/b/a Southern Railroad K. Fiorilla, Capehart & Scatchard, P.A., E. Future Meeting Scheduling 3. Updates on TSO Schedule, CERT Company of New Jersey—Lease and 8000 Midlantic Drive, Suite 300S, Plan and Final Products (30 min/ Operation Exemption—Consolidated Mount Laurel, NJ 08054. 945–1015) Rail Corporation According to SRNJ, this action is exempt from environmental review 4. SC–147 TOR Revisions JP Rail, Inc. d/b/a Southern Railroad under 49 CFR 1105.6(c) and exempt A. Final MASPS for Interoperability Company of New Jersey (SRNJ), a Class from historic review under 49 CFR of Collision Avoidance Systems III rail carrier, has filed a verified notice 1105.8(b). Language 5. ACAS XA/XO MOPS of exemption under 49 CFR 1150.41 to Board decisions and notices are lease from Consolidated Rail 6. Final Review and Comment/Open available on our website at Consultation Overview Corporation (Conrail),1 a Class III ‘‘WWW.STB.GOV.’’ railroad, and to operate an 7. Working Group Comment Resolution approximately 10.86-mile rail line, Decided: April 11, 2018. Review and Status 8. Open Comments known as the Salem Running Track and By the Board, Scott M. Zimmerman, Acting Director, Office of Proceedings. A. Discussion the Swede Industrial Track, which 9. ACAS XA/XO MOPS Approval extends from a point 125 feet +/¥ south Raina Contee, Clearance Clerk. Consideration of the southern edge of South Barber 10. Next Steps Avenue in the City of Woodbury, to [FR Doc. 2018–08024 Filed 4–16–18; 8:45 am] A. Comment Resolution milepost 10.86, at the southeast corner BILLING CODE 4915–01–P Implementation Work–Plan of Auburn Road in the Borough of B. European Validation Process/ Swedesboro, all in Gloucester County, Schedule N.J. (the Line). SRNJ states that the Line DEPARTMENT OF TRANSPORTATION 11. ACAS XU includes a public delivery track I. Report from ACAS XU WG connected to the Salem Running Track Federal Aviation Administration 12. Summary and Adjourn near its northern terminus but does not 13. Note: Plenary May Continue to include the Penns Grove Wye. Eighty Eighth RTCA SC–147 Plenary Friday, May 18th Only if All According to SRNJ, it is entering into Session Joint With EUROCAE WG–75 Business is not Concluded on Thursday, May 17th. a lease agreement and an interchange AGENCY: Federal Aviation agreement with Conrail, which would Administration (FAA), U.S. Department Attendance is open to the interested allow SRNJ to operate over the Line and of Transportation (DOT). public but limited to space availability. interchange railcars with Conrail at an With the approval of the chairman, interchange track located in the City of ACTION: Eighty Eighth RTCA SC–147 members of the public may present oral Woodbury. Plenary Session Joint With EUROCAE statements at the meeting. Persons SRNJ certifies that its projected WG–75. wishing to present statements or obtain revenues will not exceed those that SUMMARY: The FAA is issuing this notice information should contact the person would qualify it as a Class III rail carrier to advise the public of a meeting of listed in the FOR FURTHER INFORMATION and will not exceed $5 million. SRNJ Eighty Eighth RTCA SC–147 Plenary CONTACT section. Members of the public states that the agreement does not Session Joint with EUROCAE WG–75. may present a written statement to the involve a provision or agreement that committee at any time. may limit future interchange with a DATES: The meeting will be held May 18, 2018 9:00 a.m.–3:30 p.m. Issued in Washington, DC, on April 12, third party connecting carrier. 2018. The transaction may be consummated ADDRESSES: The meeting will be held at: Michelle Swearingen, on or after May 2, 2018, the effective RTCA Headquarters, 1150 18th Street date of the exemption (30 days after the NW, Suite 910, Washington, DC 20036. Systems and Equipment Standards Branch, 2 AIR–6B0, Policy and Innovation Division, verified notice was filed). FOR FURTHER INFORMATION CONTACT: Al AIR–600, Federal Aviation Administration. If the verified notice contains false or Secen at [email protected] or 202–330– [FR Doc. 2018–07953 Filed 4–16–18; 8:45 am] misleading information, the exemption 0647, or The RTCA Secretariat, 1150 BILLING CODE 4910–13–P is void ab initio. Petitions to revoke the 18th Street NW, Suite 910, Washington, exemption under 49 U.S.C. 10502(d) DC 20036, or by telephone at (202) 833– may be filed at any time. The filing of 9339, fax at (202) 833–9434, or website DEPARTMENT OF TRANSPORTATION a petition to revoke will not at http://www.rtca.org. automatically stay the effectiveness of SUPPLEMENTARY INFORMATION: Pursuant Federal Highway Administration the exemption. Petitions to stay must be to section 10(a)(2) of the Federal [Docket No. FHWA–2018–0026] filed no later than April 24, 2018 (at Advisory Committee Act (Pub. L. 92– least seven days before the exemption 463, 5 U.S.C., App.), notice is hereby Agency Information Collection becomes effective). given for a meeting of the Eighty Eighth Activities: Request for Comments for An original and 10 copies of all RTCA SC–147 Plenary Session Joint the Renewal of a Previously Approved pleadings, referring to Docket No. FD with EUROCAE WG–75. The agenda Information Collection 36172, must be filed with the Surface will include the following: AGENCY: Federal Highway 1 SRNJ states that Conrail is indirectly owned by 1. Thursday, May 17 (and Possibly Administration (FHWA), DOT. CSX Corporation and Norfolk Southern Friday May 18), 2018 ACTION: Notice and request for Corporation. 2. Opening Plenary Session 2 SRNJ has requested that the effective date of the comments. exemption be advanced to May 1, 2018, so that A. Chairmen’s Opening Remarks/ operations may commence on that date. This Introductions SUMMARY: In compliance with the request will be addressed in a separate decision. B. DFO Statement and RTCA Policies Paperwork Reduction Act (PRA) of

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1995, this notice announces that FHWA increasing dependence on truck Authority: The Paperwork Reduction Act will submit the collection of transport requires that data be available of 1995; 44 U.S.C. Chapter 35, as amended; information described below to the to better assess its overall contribution and 49 CFR 1.48. Office of Management and Budget to the Nation’s well-being. In Issued On: April 11, 2018. (OMB) for review and comment. The conducting the data collection, the Michael Howell, Federal Register Notice with a 60-day FHWA will be requesting that State Information Collection Officer. comment period soliciting comments on Departments of Transportations [FR Doc. 2018–07985 Filed 4–16–18; 8:45 am] the following collection of information (SDOTs) report traffic volume, vehicle BILLING CODE 4910–22–P was published on February 8, 2018. The classification, vehicle weight data and PRA submission describes the nature of nonmotorized data which they collect as the information collection and its part of their existing traffic monitoring DEPARTMENT OF TRANSPORTATION expected cost and burden. programs, including other sources such DATES: Please submit comments by May as local governments and traffic Federal Highway Administration operations. States and local 17, 2018. [Docket No. FHWA–2018–0023] ADDRESSES: You may submit comments governments collect nonmotorized and identified by DOT Docket ID 2018–0026 motorized traffic volume, vehicle Agency Information Collection by any of the following methods: classification data, and vehicle weight Activities: Request for Comments for Website: For access to the docket to data throughout the year using detection the Renewal of a Previously Approved read background documents or devices. The data should be Information Collection comments received go to the Federal representative of all public roads within eRulemaking Portal: Go to http:// State boundaries. The data will allow AGENCY: Federal Highway www.regulations.gov.. Follow the online transportation professionals at the Administration (FHWA), DOT. instructions for submitting comments. Federal, State, and metropolitan levels ACTION: Notice and request for Fax: 1–202–493–2251. to make informed decisions about comments. Mail: Docket Management Facility, policies and plans. U.S. Department of Transportation, Respondents: 52 SDOTs, including SUMMARY: In compliance with the West Building Ground Floor, Room the District of Columbia and Puerto Paperwork Reduction Act (PRA) of W12–140, 1200 New Jersey Avenue SE, Rico. 1995, this notice announces that FHWA Washington, DC 20590–0001. Frequency: Annually. will submit the collection of Hand Delivery or Courier: U.S. Estimated Average Burden per information described below to the Department of Transportation, West Response: Each of the SDOTs already Office of Management and Budget Building Ground Floor, Room W12–140, collect traffic data for various purposes. (OMB) for review and comment. The 1200 New Jersey Avenue SE, In accordance with 23 U.S.C. 303, each Federal Register Notice with a 60-day Washington, DC 20590, between 9 a.m. State has a Traffic Monitoring System in comment period soliciting comments on and 5 p.m. ET, Monday through Friday, place so the data collection burden the following collection of information except Federal holidays. relevant for this notice is the additional was published on February 8, 2018. The PRA submission describes the nature of FOR FURTHER INFORMATION CONTACT: burden for each State to provide a copy the information collection and its Steven Jessberger, 202–366–5052, of their traffic data using the record expected cost and burden. Federal Highway Administration, formats specified in the Traffic Department of Transportation, Office of Monitoring Guide. Automation and DATES: Please submit comments by May Highway Policy Information, 1200 New online tools continue to be developed in 17, 2018. Jersey Avenue SE, Washington, DC support of the TMAS and the capability ADDRESSES: You may submit comments 20590, Monday through Friday, except now exists for online submission and identified by DOT Docket ID 2014–0028 Federal holidays. validation of total volume data. The by any of the following methods: SUPPLEMENTARY INFORMATION: estimated average monthly burden is 2.5 Website: For access to the docket to Title: Travel Monitoring Analysis hours for an annual burden of 30 hours. read background documents or System (TMAS). Estimated Total Annual Burden comments received go to the Federal OMB Control Number: 2125–0587. Hours: Total burden will be 1,560 hours. eRulemaking Portal: Go to http:// Background: Title 49, United States Public Comments Invited: You are www.regulations.gov. Follow the online Code, Section 301, authorizes the DOT asked to comment on any aspect of this instructions for submitting comments. to collect statistical information relevant information collection, including: (1) Fax: 1–202–493–2251. to domestic transportation. The FHWA Whether the proposed collection of Mail: Docket Management Facility, is continuing to develop the TMAS to information is necessary for the U.S. U.S. Department of Transportation, house data that will enable analysis of DOT’s performance, including whether West Building Ground Floor, Room the amount and nature of both vehicular the information will have practical W12–140, 1200 New Jersey Avenue SE, and nonmotorized travel at the national utility; (2) the accuracy of the U.S. Washington, DC 20590–0001. and regional levels. The information DOT’s estimate of the burden of the Hand Delivery or Courier: U.S. will be used by the FHWA and other proposed information collection; (3) Department of Transportation, West DOT agencies to evaluate changes in ways to enhance the quality, usefulness, Building Ground Floor, Room W12–140, vehicular and nonmotorized travel to and clarity of the collected information; 1200 New Jersey Avenue SE, assess impacts on highway safety, and (4) ways that the burden could be Washington, DC 20590, between 9 a.m. national travel trend, national travel minimized, including the use of and 5 p.m. ET, Monday through Friday, demand, the role of travel in economic electronic technology, without reducing except Federal holidays. productivity, impacts of changes in the quality of the collected information. FOR FURTHER INFORMATION CONTACT: truck travel on infrastructure condition, The agency will summarize and/or Samantha Lubkin, 202–366–1575, Office and maintenance of our Nation’s include your comments in the request of Bridges and Structures, Federal mobility while protecting the human for OMB’s clearance of this information Highway Administration, Department of and natural environment. The collection. Transportation, 1200 New Jersey

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Avenue SE, Washington, DC 20590, associated with this renewal is the following collection of information Monday through Friday, except Federal 2,496,990 hours. This estimated figure is was published on February 8, 2018. The holidays. based on 307,500 annual instances for PRA submission describes the nature of SUPPLEMENTARY INFORMATION: routine, fracture critical, and the information collection and its Title: National Bridge Inspection underwater inspections multiplied by 8 expected cost and burden. Program. hours (2,460,000 hours); plus 72,552 DATES: Please submit comments by May Background: This collection is annual element inspections multiplied 17, 2018. necessary to meet legislative by 25 minutes (30,230 hours); plus 90 ADDRESSES: You may submit comments requirements of Title 23 United States hours for each cost report multiplied by identified by DOT Docket ID 2014–0027 Code section 144, and the Code of 52 reports (4,680 hours); plus 40 hours by any of the following methods: Federal Regulations, 23 Highways Part for follow up on critical findings Website: For access to the docket to 650, Subpart C—National Bridge multiplied by 52 respondents (2,080 read background documents or Inspection Standards which require hours) for a combined annual burden of comments received go to the Federal States, Federal Agencies, and Tribal 2,496,990 hours. eRulemaking Portal: Go to http:// Governments to: (1) Perform and report Public Comments Invited: You are www.regulations.gov. Follow the online inventory data from routine inspections, asked to comment on any aspect of this instructions for submitting comments. fracture critical inspections, and information collection, including: (1) Fax: 1–202–493–2251. underwater inspections as appropriate Whether the proposed collection of Mail: Docket Management Facility, for all highway bridges on public roads, information is necessary for the U.S. U.S. Department of Transportation, and element level inspections for DOT’s performance, including whether West Building Ground Floor, Room highway bridges on the National the information will have practical W12–140, 1200 New Jersey Avenue SE, Highway System; (2) report costs utility; (2) the accuracy of the U.S. Washington, DC 20590–0001. associated with the replacement of DOT’s estimate of the burden of the Hand Delivery or Courier: U.S. structurally deficient bridges; and (3) proposed information collection; (3) Department of Transportation, West follow up on critical findings. The ways to enhance the quality, usefulness, Building Ground Floor, Room W12–140, bridge inspection and replacement cost and clarity of the collected information; 1200 New Jersey Avenue SE, information that is provided to the and (4) ways that the burden could be Washington, DC 20590, between 9 a.m. FHWA is on an annual basis. The minimized, including the use of and 5 p.m. ET, Monday through Friday, critical findings information is electronic technology, without reducing except Federal holidays. periodically provided to the FHWA. The the quality of the collected information. bridge information is used for multiple SUPPLEMENTARY INFORMATION: The agency will summarize and/or Title: Emergency Relief Funding purposes, including: (1) The include your comments in the request determination of the condition of the Applications. for OMB’s clearance of this information OMB Control Number: 2125–0525. Nation’s bridges which is included in a collection. biennial report to Congress on the Status Background: Congress authorized in of the Nation’s Bridges; (2) for various Authority: The Paperwork Reduction Act Title 23, United States Code, Section additional reports to Congress on Bridge of 1995; 44 U.S.C. Chapter 35, as amended; 125, a special program from the and 49 CFR 1.48. Safety; (3) the data source for executing Highway Trust Fund for the repair or various sections of the Federal-aid Issued On: April 11, 2018. reconstruction of Federal-aid highways program which involve highway Michael Howell, and roads on Federal lands which have bridges; (4) the data source for assessing Information Collection Officer. suffered serious damage as a result of natural disasters or catastrophic failures the bridge penalty provisions of Title 23 [FR Doc. 2018–07989 Filed 4–16–18; 8:45 am] from an external cause. This program, United States Code section 119; (5) the BILLING CODE 4910–22–P data source for the evaluation of bridge commonly referred to as the Emergency performance measures established in Relief or ER program, supplements the Title 23 United States Code section 150; DEPARTMENT OF TRANSPORTATION commitment of resources by States, (6) for conducting oversight of the their political subdivisions, or other National Bridge Inspection Program at Federal Highway Administration Federal agencies to help pay for unusually heavy expenses resulting the State, Federal agency, and Tribal [Docket No. FHWA–2018–0024] level; and (7) for strategic national from extraordinary conditions. The defense needs. Agency Information Collection applicability of the ER program to a Respondents: 52 State highway Activities: Request for Comments for natural disaster is based on the extent agencies including the District of the Renewal of a Previously Approved and intensity of the disaster. Damage to Columbia and Puerto Rico, Federal Information Collection. highways must be severe, occur over a Agencies, and Tribal Governments. The wide area, and result in unusually high number of inspections per respondent AGENCY: Federal Highway expenses to the highway agency. varies in accordance with the National Administration (FHWA), DOT. Examples of natural disasters include Bridge Inspection Standards. ACTION: Notice and request for floods, hurricanes, earthquakes, Estimated Average Burden per comments. tornadoes, tidal waves, severe storms, Response: The estimated average burden and landslides. Applicability of the ER for each bridge inspection is 8 hours. SUMMARY: In compliance with the program to a catastrophic failure due to The estimated average burden for each Paperwork Reduction Act (PRA) of an external cause is based on the criteria element level inspection is 25 minutes. 1995, this notice announces that FHWA that the failure was not the result of an The estimated average burden for each will submit the collection of inherent flaw in the facility but was cost collection report is 90 hours. The information described below to the sudden, caused a disastrous impact on estimated average burden for follow up Office of Management and Budget transportation services, and resulted in on critical findings is 40 hours. (OMB) for review and comment. The unusually high expenses to the highway Estimated Total Annual Burden Federal Register Notice with a 60-day agency. A bridge suddenly collapsing Hours: The annual burden hours comment period soliciting comments on after being struck by a barge is an

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example of a catastrophic failure from Issued On: April 11, 2018. actions were taken, are described in the an external cause. The ER program Michael Howell, environmental assessment (EA) or provides for repair and restoration of Information Collection Officer. environmental impact statement (EIS) highway facilities to pre-disaster [FR Doc. 2018–07986 Filed 4–16–18; 8:45 am] issued in connection with the project conditions. Restoration in kind is BILLING CODE 4910–22–P and in other key project documents. The therefore the predominate type of repair EA or EIS, and other key documents for expected to be accomplished with ER the listed projects are available by funds. Generally, all elements of the DEPARTMENT OF TRANSPORTATION contacting the FHWA or the Colorado damaged highway within its cross Department of Transportation at the Federal Highway Administration addresses provided above. The EA, section are eligible for ER funds. Finding of No Significant Impact Roadway items that are eligible may Notice of Final Federal Agency Actions (FONSI), Final EIS, and Record of include: Pavement, shoulders, slopes on Proposed Highways in Colorado Decision (ROD) documents can be and embankments, guardrail, signs and viewed and downloaded from the traffic control devices, bridges, culverts, AGENCY: Federal Highway Administration (FHWA), Department of websites listed below. bike and pedestrian paths, fencing, and Transportation (DOT). This notice applies to all Federal retaining walls. Other eligible items may agency decisions on each project as of ACTION: Notice of limitation on claims include: Engineering and right-of-way the issuance date of this notice and all for judicial review of actions by FHWA costs, debris removal, transportation laws under which such actions were and other Federal agencies. system management strategies, taken. This notice does not, however, administrative expenses, and equipment SUMMARY: This notice announces actions alter or extend the limitation period of rental expenses. This information taken by the FHWA and other Federal 150 days for challenges to final agency collection is needed for the FHWA to agencies that are final. The actions actions subject to previous notices fulfill its statutory obligations regarding relate to various proposed highway published in the Federal Register. funding determinations for ER eligible projects in the State of Colorado. Those This notice applies to all Federal damages following a disaster. The actions grant licenses, permits, and agency decisions, actions, approvals, regulations covering the FHWA ER approvals for the projects. licenses and permits on the project as of the issuance date of this notice, program are contained in 23 CFR part DATES: By this notice, the FHWA is including but not limited to those 668. advising the public of final agency actions subject to 23 U.S.C. 139(l)(1). A arising under the following laws, as Respondents: 50 State Transportation claim seeking judicial review of the amended: Departments, the District of Columbia, Federal agency actions on any of the 1. General: National Environmental Puerto Rico, Guam, American Samoa, listed highway projects will be barred Policy Act (NEPA) [42 U.S.C. 4321– Northern Mariana Islands, and the unless the claim is filed on or before 4370h]; Federal-Aid Highway Act [Title Virgin Islands. September 14, 2018. If the Federal law 23] and associated regulations [CFR part Estimated Average Annual Burden: that authorizes judicial review of a 23]. 2. Air: Clean Air Act, [42 U.S.C. 7401– The respondents submit an estimated claim provides a time period of less 7671(q)] (transportation conformity); total of 30 applications each year. Each than 150 days for filing such claim, then Intermodal Surface Transportation that shorter time period still applies. application requires an estimated Efficiency Act of 1991, Congestion average of 250 hours to complete. FOR FURTHER INFORMATION CONTACT: Mitigation and Air Quality Estimated Total Annual Burden Stephanie Gibson, Environmental Improvement Program (Sec. 1008 U.S.C. Hours: Total estimated average annual Program Manager, Federal Highway 149). burden is 7,500 hours. Administration Colorado Division, 3. Land: Section 4(f) of The 12300 W Dakota Avenue, Suite 180, Public Comments Invited: You are Department of Transportation Act: [49 Lakewood, Colorado 80228, telephone: U.S.C. 303] Farmland Protection Policy asked to comment on any aspect of this 720–963–3013, email: Act (FPPA) [7 U.S.C. 4201–4209]. Solid information collection, including: (1) [email protected]. Normal Waste Disposal Act, as amended by the Whether the proposed collection of business hours are 8:30 a.m. to 5:00 p.m. Resource Conservation and Recovery information is necessary for the U.S. (Mountain time), Monday through Act of 1976 (42 U.S.C. 6901, et seq.); DOT’s performance, including whether Friday, except Federal Holidays. You Landscaping and Scenic Enhancement the information will have practical may also contact David Singer, NEPA (Wildflowers) [23 U.S.C. 319]. utility; (2) the accuracy of the U.S. Program Manager, Colorado Department 4. Wildlife: Endangered Species Act DOT’s estimate of the burden of the of Transportation, 4201 E. Arkansas [16 U.S.C. 1531–1544]; Fish and proposed information collection; (3) Avenue, Shumate Building, Denver, Wildlife Coordination Act [16 U.S.C. ways to enhance the quality, usefulness, Colorado 80222, 303–757–9878, 661–667(e)]; Migratory Bird Treaty Act and clarity of the collected information; [email protected], normal [16 U.S.C. 703–712]. Plant Protection and (4) ways that the burden could be business hours are 8:00 a.m. to 4:30 p.m. Act [7 U.S.C. 7701 et seq.]. minimized, including the use of (Mountain time), Monday through 5. Historic and Cultural Resources: electronic technology, without reducing Friday, except Federal Holidays. Section 106 of the National Historic the quality of the collected information. SUPPLEMENTARY INFORMATION: Notice is Preservation Act of 1966, [54 U.S.C. The agency will summarize and/or hereby given that the FHWA and other 306108]; Archeological Resources include your comments in the request Federal agencies have taken final agency Protection Act of 1977 [16 U.S.C. for OMB’s clearance of this information actions 23 U.S.C. 139(l)(1) by issuing 470(aa)–470(mm)]; Archeological and collection. licenses, permits, and approvals for the Historic Preservation Act [16 U.S.C. highway projects in the State of 469–469c–2]; American Indian Authority: The Paperwork Reduction Act Colorado that are listed below. The Religious Freedom Act [42 U.S.C. 1996]; of 1995; 44 U.S.C. Chapter 35, as amended; actions by the Federal agencies on a Native American Grave Protection and and 49 CFR 1.48. project, and the laws under which such Repatriation Act [25 U.S.C. 3001–3013].

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6. Social and Economic: Civil Rights 30 and E–470 in the regional deficiencies, improve safety, mobility Act of 1964 [42 U.S.C. 2000(d)– transportation network of northeastern and accessibility, and replace aging and 2000(d)(1)]; Uniform Relocation Aurora. Signed NEPA documents and obsolete infrastructure. Signed NEPA Assistance and Real Property permits: EA signed June 23, 2016 and documents and permits: FEIS was Acquisition Act [42 U.S.C. 61]. FONSI signed December 8, 2016. signed August 19, 2011. Revised ROD1 7. Wetlands and Water Resources: https://www.auroragov.org/ (SH 392 to SH 14) was signed August Clean Water Act [33 U.S.C. 1251–1387 business_services/planning/ 16, 2017. Revised ROD1 (I–25/SH 7 (Sections 319, 401, 404, and 408)]; Land plans_and_studies/transportation_ Interchange) was signed October 20, and Water Conservation Fund Act [16 planning/6th_avenue_parkway_ 2017. ROD2 (120th Avenue to SH 7) was U.S.C. 460l–4–460l–11]; Safe Drinking extension/ and https://www.codot.gov/ signed September 28, 2015. ROD3 Water Act [42 U.S.C. 300f—300j–9.]; projects/sixth-avenue-parkway- (Crossroads Boulevard) was signed June Flood Disaster Protection Act [42 U.S.C. extension-to-e-470. 8, 2016. ROD4 (SH 56 to SH 392) was 4001–4129]. 3. Martin Luther King, Jr. Boulevard signed April 27, 2017. ROD5 (Vine 8. Hazardous Materials: Extension EA and FONSI. Project Drive/County Road 48 Bridge Comprehensive Environmental Location: Near Havana Way, between Replacement) was signed December 1, Response, Compensation, and Liability Havana Street and Peoria Street, Denver, 2017. https://www.codot.gov/projects/ Act [42 U.S.C. 9601–9675]; Superfund Colorado. Project reference number: north-i-25-eis/Northi25rod. Amendments and Reauthorization Act STU M320–099. Project overview: The 6. US 50 Tier 1 Combined Final EIS of 1986 [Pub. L. 99–499]; Resource existing Havana Way would be renamed and ROD. Project Location: A 150-mile- Conservation and Recovery Act [42 MLK Blvd., widened to a four-lane long portion of US 50 between Pueblo U.S.C. 6901–6992(k)]. arterial, and extended east to the Peoria and the vicinity of the Colorado-Kansas 9. Executive Orders: E.O. 11514 Street and Fitzsimons Parkway state line, going through Pueblo, Otero, Protection and Enhancement of intersection. Project Purpose: The Bent, and Prowers Counties. Project Environmental Quality; E.O. 11593 purpose of the project is to improve an reference number: NH 0504–037. Project Protection and Enhancement of Cultural east-west arterial connection between overview: The Build Alternative Resources; E.O. 11988 Floodplain Havana Street and Peoria Street, a consists of constructing a four-lane Management; E.O. 11990 Protection of distance of 1.1 miles, improving traffic expressway on or near the existing US Wetlands; E.O. 12898 Federal Actions to congestion and reducing out-of- 50 alignment, including new alignments Address Environmental Justice in direction travel. Signed NEPA around ten towns to preserve their Minority Populations and Low Income documents and permits: EA signed July business districts and historic Populations; E.O. 13007 Indian Sacred 25, 2011 and FONSI signed October 19, downtown areas. Project Purpose: The Sites; E.O. 13112 Invasive Species; E.O. 2017. https://www.denvergov.org/ purpose of the project is to improve 13175 Consultation and Coordination content/denvergov/en/denver- safety and mobility for local, regional, with Indian Tribal Governments; E.O. department-of-public-works/projects/ and long-distance users of US 50 for 13287 Preserve America. current/mlk-boulevard-extension.html. present and future travel demand. This The projects subject to this notice are: 4. US 50 West, Wills Blvd. to will be accomplished by balancing the 1. I–76 and Bridge Street Interchange McCulloch Blvd. (Milepost 313 to mobility and access needs of these users EA and FONSI. Project Location: I–76 Milepost 307) EA and FONSI. Project and also providing the flexibility to and Bridge Street, Brighton, Colorado. Location: US 50 in the western part of meet future travel demands. Signed Project reference number: 0761–202. Pueblo, Colorado. Project reference NEPA documents and permits: The Project overview: The project would number: STA 0503–088. Project Combined Final EIS/ROD was signed on construct a new interchange at I–76 and overview: The project would widen US December 11, 2017. https:// Bridge Street (SH 7). Project Purpose: 50 from four to six lanes, and change www.codot.gov/projects/us50e. The purpose of the project is to increase intersections to interchanges at US 50 at 7. Colorado State Highway 470 local and regional east-west Purcell Blvd. and Pueblo Blvd. Project (C–470) Corridor, Kipling Parkway to connectivity, reduce the amount of Purpose: The purpose of the project is I–25 EA and FONSI. Project Location: A travel delay through the planning to improve safety; increase mobility, 13.75-mile portion of C–470 in the horizon year of 2035, and improve such as reducing travel time, relieving southern portion of the Denver traffic flow in the project area. Signed traffic congestion; and improve level of metropolitan area. Project reference NEPA documents and permits: EA was service to the connecting road network. number: NH 4701–103. Project signed January 23, 2015 and FONSI was Signed NEPA documents and permits: overview: The project involves adding signed July 8, 2015. https:// EA signed April 21, 2016 and FONSI one managed, tolled express lane in www.brightonco.gov/605/I-76-and- signed August 17, 2016. https:// each direction between I–25 and Kipling Bridge-Street-Interchange-Proje and www.codot.gov/library/studies/us50ea. Parkway, and a second managed lane as https://www.codot.gov/library/studies/ 5. North I–25 EIS and RODs. Project follows: Westbound, I–25 to Lucent i76bridgestreetea. Location: I–25 corridor from Denver to Boulevard, and eastbound, Broadway to 2. 6th Avenue Parkway Extension EA Wellington in northern Colorado. I–25. The purpose of the project is to and FONSI. Project Location: 6th Project reference number: IM 0253(179). provide congestion relief, decrease Avenue from SH 30 to E–470, Aurora, Project overview: The I–25 North project travel delay, and improve corridor Colorado. Project overview: This project is an improvements project that reliability between Kipling Parkway and would construct the 6th Avenue includes; general purpose lanes, tolled I–25 on the C–470 corridor. Project Parkway extension along a new roadway express lanes, interchange Purpose: The purpose of the project is alignment between State Highway (SH reconstruction, and multi-modal to address existing and future C–470 30) and the 6th Avenue Parkway/E–470 services such as: I–25 express bus, US congestion between Kipling Parkway Tollway (E–470) interchange Project 85 commuter bus, and commuter rail and I–25, reduce traveler delay, and Purpose: The purpose of this project is service. Project purpose: The purpose of improve travel time reliability for to enhance east-west mobility by the I–25 North project is to make corridor users through the year 2035. implementing a transportation solution improvements to provide modal Signed NEPA documents and permits: that will close a critical gap between SH alternatives, correct geometric This statute of limitations notice applies

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to the Reevaluation signed on March 28, Ground Floor, Room W12–140, exemption.’’ The statute also allows the 2018 that provided additional detail to Washington, DC 20590–0001. Agency to renew exemptions at the end the noise analysis that was contained in • Hand Delivery: West Building of the five-year period. FMCSA grants the Revised Environmental Assessment Ground Floor, Room W12–140, 1200 exemptions from the FMCSRs for a two- (EA) (signed on July 24, 2015) and the New Jersey Avenue SE, Washington, year period to align with the maximum Finding of No Significant Impact DC, between 9 a.m. and 5 p.m., e.t., duration of a driver’s medical (FONSI) (signed on November 20, 2015). Monday through Friday, except Federal certification. The statute of limitations notice for the Holidays. The physical qualification standard FONSI expired on May 16, 2016. • Fax: 1–202–493–2251. for drivers regarding diabetes found in 49 CFR 391.41(b)(3) states that a person Authority: 23 U.S.C. 139(l)(1). Instructions: Each submission must include the Agency name and the is physically qualified to drive a CMV Issued on: April 2, 2018. docket number(s) for this notice. Note if that person has no established John M. Cater, that all comments received will be medical history or clinical diagnosis of Division Administrator, Lakewood, Colorado. posted without change to http:// diabetes mellitus currently requiring [FR Doc. 2018–07877 Filed 4–16–18; 8:45 am] www.regulations.gov, including any insulin for control. BILLING CODE 4910–22–P personal information provided. Please The 191 individuals listed in this see the Privacy Act heading below for notice have requested renewal of their further information. exemptions from the diabetes standard DEPARTMENT OF TRANSPORTATION Docket: For access to the docket to in 49 CFR 391.41(b)(3), in accordance read background documents or with FMCSA procedures. Accordingly, Federal Motor Carrier Safety comments, go to http:// FMCSA has evaluated these Administration www.regulations.gov at any time or applications for renewal on their merits [Docket No. FMCSA–2011–0382; FMCSA– Room W12–140 on the ground level of and decided to extend each exemption 2011–0383; FMCSA–2013–0194; FMCSA– the West Building, 1200 New Jersey for a renewable two-year period. 2014–0012; FMCSA–2014–0013; FMCSA– Avenue SE, Washington, DC, between 9 II. Request for Comments 2015–0342; FMCSA–2015–0343; FMCSA– a.m. and 5 p.m., e.t., Monday through 2016–0034] Friday, except Federal holidays. The Interested parties or organizations FDMS is available 24 hours each day possessing information that would Qualification of Drivers; Exemption e.t., 365 days each year. If you want otherwise show that any, or all, of these Applications; Diabetes acknowledgment that we received your drivers are not currently achieving the comments, please include a self- statutory level of safety should AGENCY: Federal Motor Carrier Safety immediately notify FMCSA. The Administration (FMCSA), DOT. addressed, stamped envelope or postcard or print the acknowledgement Agency will evaluate any adverse ACTION: Notice of renewal of evidence submitted and, if safety is exemptions; request for comments. page that appears after submitting comments online. being compromised or if continuation of the exemption would not be consistent SUMMARY: FMCSA announces its Privacy Act: In accordance with 5 with the goals and objectives of 49 decision to renew exemptions for 191 U.S.C. 553(c), DOT solicits comments U.S.C. 31136(e) and 31315, FMCSA will individuals from its prohibition in the from the public to better inform its take immediate steps to revoke the Federal Motor Carrier Safety rulemaking process. DOT posts these exemption of a driver. Regulations (FMCSRs) against persons comments, without edit, including any with insulin-treated diabetes mellitus personal information the commenter III. Basis for Renewing Exemptions (ITDM) from operating commercial provides, to http://www.regulations.gov, Under 49 U.S.C. 31315(b)(1), an motor vehicles (CMVs) in interstate as described in the system of records exemption may be granted for no longer commerce. The exemptions enable these notice (DOT/ALL–14 FDMS), which can than two years from its approval date individuals with ITDM to continue to be reviewed at http://www.dot.gov/ and may be renewed upon application. operate CMVs in interstate commerce. privacy. In accordance with 49 U.S.C. 31136(e) DATES: Each group of renewed FOR FURTHER INFORMATION CONTACT: Ms. and 31315, each of the 191 applicants exemptions were applicable on the Christine A. Hydock, Chief, Medical has satisfied the renewal conditions for dates stated in the discussions below Programs Division, 202–366–4001, obtaining an exemption from the and will expire on the dates stated in [email protected], FMCSA, diabetes requirement (77 FR 10612; 77 the discussions below. Comments must Department of Transportation, 1200 FR 13686; 77 FR 20874; 77 FR 25227; be received on or before May 17, 2018. New Jersey Avenue SE, Room W64–224, 79 FR 6987; 79 FR 10612; 79 FR 14579; ADDRESSES: You may submit comments Washington, DC 20590–0001. Office 79 FR 18388; 79 FR 27685; 79 FR 28590; bearing the Federal Docket Management hours are from 8:30 a.m. to 5:30 p.m., 81 FR 10703; 81 FR 14179; 81 FR 14197; System (FDMS) Docket No. FMCSA– e.t., Monday through Friday, except 81 FR 39318; 81 FR 40743; 81 FR 42043; 2011–0382; FMCSA–2011–0383; Federal holidays. If you have questions 81 FR 85317). They have maintained FMCSA–2013–0194; FMCSA–2014– regarding viewing or submitting their required medical monitoring and 0012; FMCSA–2014–0013; FMCSA– material to the docket, contact Docket have not exhibited any medical issues 2015–0342; FMCSA–2015–0343; Services, telephone (202) 366–9826. that would compromise their ability to FMCSA–2016–0034 using any of the SUPPLEMENTARY INFORMATION: safely operate a CMV during the following methods: previous two-year exemption period. • Federal eRulemaking Portal: Go to I. Background These factors provide an adequate basis http://www.regulations.gov. Follow the Under 49 U.S.C. 31136(e) and 31315, for predicting each driver’s ability to online instructions for submitting FMCSA may grant an exemption for five continue to drive safely in interstate comments. years if it finds ‘‘such exemption would commerce. Therefore, FMCSA • Mail: Docket Management Facility; likely achieve a level of safety that is concludes that extending the exemption U.S. Department of Transportation, 1200 equivalent to or greater than the level for each of these drivers for a period of New Jersey Avenue SE, West Building that would be achieved absent such two years is likely to achieve a level of

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safety equal to that existing without the William C. Nelson (IA) Harold E. Adams, Sr. (IL) exemption. Howard L. Nelson (IA) Jerry J. Altenburg (WI) In accordance with 49 U.S.C. 31136(e) Chris R. Niles (WA) Juanita K. Anderson (MN) and 31315, the following groups of Keith E. Osterbaan (MI) Chris L. Austin (AL) drivers received renewed exemptions in Ryan M. Ottis (ND) Cory M. Bessette (NY) the month of April and are discussed Bolaji B. Oyegbola (DC) Daryl K. Birr (WI) below: Steven M. Parsons (WV) Samuel E. Bostic (WV) As of April 1, 2018, and in accordance Teddy D. Peller (AL) James R. Burch, II (NC) with 49 U.S.C. 31136(e) and 31315, the Jeffrey P. Peloquin (NC) Walter L. Butcher, IV (PA) following 84 individuals have satisfied Scott A. Pietruszynksi (IL) Russell W. Cadman (CO) the renewal conditions for obtaining an William L. Reece (ND) Michael J. Chevalier, Jr. (NJ) exemption from the rule prohibiting John P. Reed, III (DE) James R. Cockerham (IN) drivers with ITDM from driving CMVs Randy D. Rinnels (IA) Alexander W. Coleman (WA) in interstate commerce (79 FR 6987; 79 Denise D. Ruffin (MS) Earl J. Collier, Jr. (MA) FR 18388; 81 FR 10703; 81 FR 40743; Thomas W. Scott, Jr. (PA) Michael R. Conley (WI) 81 FR 85317): Charles L. Spencer (NY) Carolyn J. Conover (TN) Ryan E. Stretch (MO) Gary R. Craig (PA) Dennis D. Basmajian (PA) William F. Sullivan, IV (NY) Sebastian Dacruz, Jr. (NJ) Glen A. Bayne (ND) Robert B. Thomas (PA) Scott D. Davis (KS) John R. Benshoff (OH) John R. Thompson (WI) James D. Deardoff (WA) Harry Berrios (MA) Raymond L. Torrez (MI) Joel R. Farmer (ID) Terry D. Bettcher (NE) Bore Trivuncic (FL) Samuel M. Feaganes, Jr. (VA) Jeremy S. Beyerl (PA) William M. Turner (NJ) Ronald Floyd (NY) Robert P. Blum (IA) Everette L. Twyman (MO) Donald W. Fowler, Jr. (NY) Mario Boccio (FL) James H. Vogt (IL) William A. Garrett (GA) Christopher J. Branham (SC) Ronald L. Voigt (MN) William J. Garrett (SD) Willard A. Brown (VA) Michael P. Volpe (MA) Tyrone B. Gary, Sr. (PA) Terrence K. Cannon (IL) John F. Whitesides (NC) Hardy D. Glanzer (ND) Candace L. Coccimiglio (PA) Michael C.J Wilcox (NY) Kevin E. Griebel (SD) Matthew C. Costa (MA) Donald L. Winslow (ME) Martin R. Hair (CT) Joseph F. Coyle (KY) James J. Wolf, Jr. (PA) Bruce T. Hanson (MN) Robert P. Crisp (SD) Kevin J. Yates (IL) Darrell E. Holtsoi (NM) Philip W. Cumbie (AL) The drivers were included in docket Roger J. Huffsmith (WA) John H. Cuppett (GA) numbers FMCSA–2013–0194; FMCSA– Arrington Hughes (DC) Quentin W.S. Dasilva (PA) 2015–0342. Their exemptions are Joseph P. Hurston (MA) Trisha J. Davis (ME) applicable as of April 1, 2018, and will Brian K. Hyler (WI) Eudes N. De Leon (PA) expire on April 1, 2020. James A. Iozia (NJ) Randal L. DeBord (TN) As of April 6, 2018, and in accordance Joshua D. Jaramillo (WA) Aleksandr Faynkikh (NY) with 49 U.S.C. 31136(e) and 31315, the Keven E. Johnson (TX) Paul D. Ferris (NY) following eight individuals have Calvin E. Jones, Jr. (VA) Berry C. Feuerbacher (AR) satisfied the renewal conditions for Jerry M. Kilpatrick (AL) Isaac W. Fitzgerald (UT) obtaining an exemption from the rule Rex O. King (IA) Alex C. Ford (IL) prohibiting drivers with ITDM from Russell D. Koehler (WI) Robert C. Freeman (VA) driving CMVs in interstate commerce Edward D. Krager (PA) Timothy D. Frye (MA) (77 FR 10612; 77 FR 20874; 81 FR Richard A. Lange (IL) Larry Gaskill (RI) 85317): Michael P. Leggett (WV) Thomas H. Gaskins (NC) John K. Long (MA) Rick J. Birdsall (NE) Samuel J. Gonzales (NM) George S. Luce, Jr. (OH) Steven L. Drake (CA) Gary A. Grant (WA) Russell J. Luedecker (NJ) Benjamin J. Duea (MN) Brian C. Halcomb (IL) Renee N. Lycksell (WA) Jonathan E. Hunsaker (OR) Steven R. Hatch (MI) Eugene D. Maessner (ND) William D. Larsen (SD) William D. Herman (MN) Daniel J. Mandell (NC) William W. Simmons (FL) Floyd E. Holt (VA) Brady T. Mart (IA) Ronald O. Snyder (OH) Randall L. Jastram (SD) Jack L. McClintock (PA) Douglas J. Wood (NY) Thomas M. Johnson (NM) John D. McGinley, Jr. (CA) Steven R. Jordan (NC) The drivers were included in docket Jimmie L. Melton (FL) Kevin A. Kane (NY) number FMCSA–2011–0382. Their Gareth L. Miller (OH) Ryan B. Kincade (CA) exemptions are applicable as of April 6, Jimmy C. Morcom (MI) William M. LaPrade (VA) 2018, and will expire on April 6, 2020. Kirk A. Mosier (IA) Gerald Lee (CA) As of April 16, 2018, and in Daniel A. Neuens (WI) Timothy R. Lewis (OR) accordance with 49 U.S.C. 31136(e) and Peter J. Niedzwiecki (PA) Gregory J. Littlefield (MN) 31315, the following 89 individuals Kevin R. OToole (WI) John Malloy (PA) have satisfied the renewal conditions for Mark C. Overbaugh (NY) James W. McMenamin (PA) obtaining an exemption from the rule Mario A. Papa (RI) Glen H. Miller (MI) prohibiting drivers with ITDM from Joseph R. Puliafico (NY) Daniel J. Milles, Jr. (FL) driving CMVs in interstate commerce Neal M. Quinton, Jr. (MA) Miguel A. Molina (CO) (81 FR 14179; 81 FR 14197; 81 FR Howard G. Rau (MD) Douglas B. Murrell (IN) 39318; 81 FR 42043): Andrew W. Reid (IN) Joshua A. Myers (OH) Korey D. Adams (MO) Brett M. Rice (PA)

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Jacob C. Rojan (IN) treating endocrinologist as well as an ACTION: Notice and request for Sholom Rub (NY) annual checklist with a comprehensive comments. David J. Scimecca (NY) medical evaluation; (2) each driver must Ronald D. Smith (IN) report within two business days of SUMMARY: The Internal Revenue Service, Kenneth W. Swisher (IL) occurrence, all episodes of severe as part of its continuing effort to reduce Melissa Tell (NY) hypoglycemia, significant paperwork and respondent burden, Jeremy N. Thompson (NY) complications, or inability to manage invites the general public and other Charles R. Thompson, Jr. (KY) diabetes; also, any involvement in an Federal agencies to take this Blane Tor (NJ) accident or any other adverse event in opportunity to comment on proposed Samuel C. Tracy (WA) a CMV or personal vehicle, whether or and/or continuing information Terry L. Underwood, Jr. (VA) not it is related to an episode of collections, as required by the Aaron M. Vanlanduit (MO) hypoglycemia; (3) each driver must Paperwork Reduction Act of 1995. William O. Wallen (IL) submit an annual ophthalmologist’s or DATES: Written comments should be Steven G. Wehrle (MO) optometrist’s report; and (4) each driver received on or before June 18, 2018 to James H. Wilkey (ID) must provide a copy of the annual be assured of consideration. Joseph M. Wilson, II (WA) medical certification to the employer for ADDRESSES: Direct all written comments Joseph A. Wilson, Sr. (MA) retention in the driver’s qualification to Laurie Brimmer, Internal Revenue Jefferson Yazzie (NM) file, or keep a copy in his/her driver’s Service, Room 6526, 1111 Constitution Michael A. Zuke, Sr. (NY) qualification file if he/she is self- Avenue NW, Washington, DC 20224. The drivers were included in docket employed. The driver must also have a FOR FURTHER INFORMATION CONTACT: To numbers FMCSA–2015–0343; FMCSA– copy of the exemption when driving, for obtain additional information, or copies 2016–0034. Their exemptions are presentation to a duly authorized of the information collection and applicable as of April 16, 2018, and will Federal, State, or local enforcement instructions, or copies of any comments expire on April 16, 2020. official. The exemption will be received, contact LaNita Van Dyke, at As of April 27, 2018, and in rescinded if: (1) The person fails to (202) 317–6009, at Internal Revenue accordance with 49 U.S.C. 31136(e) and comply with the terms and conditions Service, Room 6526, 1111 Constitution 31315, the following eight individuals of the exemption; (2) the exemption has Avenue NW, Washington, DC 20224, or have satisfied the renewal conditions for resulted in a lower level of safety than through the internet, at obtaining an exemption from the rule was maintained before it was granted; or [email protected]. prohibiting drivers with ITDM from (3) continuation of the exemption would SUPPLEMENTARY INFORMATION: driving CMVs in interstate commerce not be consistent with the goals and (77 FR 13686; 77 FR 25227; 81 FR objectives of 49 U.S.C. 31136(e) and Request for Comments 85317): 31315. The Internal Revenue Service, as part Bobby D. Bennett (GA) V. Preemption of their continuing effort to reduce Mark S. Clemence (KS) paperwork and respondent burden, Mike W. Holland (IL) During the period the exemption is in invite the general public and other Dan M. McAllister (WI) effect, no State shall enforce any law or Federal agencies to take this Paul F. Rivers (MN) regulation that conflicts with this opportunity to comment on the Marcus V. Romo (ID) exemption with respect to a person proposed or continuing information Wayne L. Snyder (OH) operating under the exemption. collections listed below in this notice, Justin K. Zimmerschied (KS) VI. Conclusion as required by the Paperwork Reduction The drivers were included in docket Act of 1995, (44 U.S.C. 3501 et seq.). number FMCSA–2011–0383. Their Based upon its evaluation of the 191 Request for Comments: Comments exemptions are applicable as of April exemption applications, FMCSA renews submitted in response to this notice will 27, 2018, and will expire on April 27, the exemptions of the aforementioned be summarized and/or included in our 2020. drivers from the rule prohibiting drivers request for Office of Management and As of April 30, 2018, and in with ITDM from driving CMVs in Budget (OMB) approval of the relevant accordance with 49 U.S.C. 31136(e) and interstate commerce. In accordance with information collection. All comments 31315, the following two individuals 49 U.S.C. 31136(e) and 31315, each will become a matter of public record. have satisfied the renewal conditions for exemption will be valid for two years Please do not include any confidential obtaining an exemption from the rule unless revoked earlier by FMCSA. or inappropriate material in your prohibiting drivers with ITDM from Issued on: April 2, 2018. comments. driving CMVs in interstate commerce Larry W. Minor, We invite comments on: (a) Whether the collection of information is (79 FR 10612; 79 FR 14579; 79 FR Associate Administrator for Policy. 27685; 79 FR 28590; 81 FR 85317): necessary for the proper performance of Charles L. Bryant, (PA); Christopher P. [FR Doc. 2018–07988 Filed 4–16–18; 8:45 am] the agency’s functions, including Martin, (NH). BILLING CODE 4910–EX–P whether the information has practical The drivers were included in docket utility; (b) the accuracy of the agency’s numbers FMCSA–2014–0012; FMCSA– estimate of the burden of the collection 2014–0013. Their exemptions are of information; (c) ways to enhance the DEPARTMENT OF THE TREASURY applicable as of April 30, 2018, and will quality, utility, and clarity of the expire on April 30, 2020. Internal Revenue Service information to be collected; (d) ways to minimize the burden of the collection of IV. Conditions and Requirements Proposed Information Collection; information on respondents, including The exemptions are extended subject Comment Request the use of automated collection to the following conditions: (1) Each techniques or other forms of information driver must submit a quarterly AGENCY: Internal Revenue Service (IRS), technology; and (e) estimates of capital monitoring checklist completed by the Treasury. or start-up costs and costs of operation,

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maintenance, and purchase of services abstracted below to the Office of Spirometry Screening Module—1,033 to provide the requested information. Management and Budget (OMB) for hours. The IRS is seeking comments review and comment. The PRA Military Overview Module—517 concerning the following form, and submission describes the nature of the hours. reporting and record-keeping information collection and its expected OEF/OIF/OND Location Module— requirements: cost and burden and it includes the 1,550 hours. Title: Distributions From an HSA, actual data collection instrument. Non-OEF/OIF/OND Location Archer MSA or Medical Advantage DATES: Comments must be submitted on Module—1,550 hours. MSA. or before May 17, 2018. OEF/OIF/OND Exposure Module— 1,033 hours. OMB Number: 1545–1517. ADDRESSES: Submit written comments Non-OEF/OIF/OND Exposure Form Number: 1099–SA. on the collection of information through Abstract: This form is used to report Module—1,033 hours. www.Regulations.gov, or to Office of Civilian Occupation and Hobby distributions from a medical savings Information and Regulatory Affairs, account as required by Internal Revenue Exposure Module—517 hours. Office of Management and Budget, Attn: Health, Smoking, and Demographics Code section 220(h). VA Desk Officer; 725 17th St. NW, Current Actions: There are no changes Module—1,550 hours. Washington, DC 20503 or sent through Medication and Dietary Supplement being made to the form at this time. electronic mail to oira_submission@ Type of Review: Extension of a Module—1,033 hours. omb.eop.gov. Please refer to ‘‘OMB Participant Status Check-In Module— currently approved collection. Control No. 2900–NEW’’ in any Affected Public: Business or other for- 517 hours. correspondence. profit organizations. Spirometry—3,617 hours. Estimated Number of Responses: FOR FURTHER INFORMATION CONTACT: Medical History Module—517 hours. 25,839. Cynthia D. Harvey-Pryor, Office of Functional Health Module—413 Estimated Time per Response: 8 min. Quality, Privacy and Risk (OQPR), hours. Estimated Total Annual Burden Department of Veterans Affairs, 810 Health Symptoms Module—310 Hours: 3,618. Vermont Avenue NW, Washington, DC hours. The following paragraph applies to 20420, (202) 461–5870 or email Current Mood Module—517 hours. Participant Feedback Module—310 the collection of information covered by [email protected]. Please hours. this notice: refer to ‘‘OMB Control No. 2900–NEW’’ Post-Visit Feedback Module—52 An agency may not conduct or in any correspondence. hours. sponsor, and a person is not required to SUPPLEMENTARY INFORMATION: Estimated Average Burden per Authority: 38 CFR part 16. respond to, a collection of information Respondent: Title: Pulmonary Health and unless the collection of information Recruitment Screening Module—5 Deployment to Southwest Asia and displays a valid OMB control number. minutes. Books or records relating to a collection Afghanistan. Spirometry Screening Module—10 of information must be retained as long OMB Control Number: 2900–NEW. Type of Review: New collection. minutes. as their contents may become material Military Overview Module—5 in the administration of any internal Abstract: The Department of Veterans Affairs Cooperative Studies Program minutes. revenue law. Generally, tax returns and OEF/OIF/OND Location Module—15 (CSP) is conducting a human subjects tax return information are confidential, minutes. research study to understand the as required by 26 U.S.C. 6103. Non-OEF/OIF/OND Location association between military Approved: April 10, 2018. Module—15 minutes. deployment to Afghanistan, Iraq, and 5 OEF/OIF/OND Exposure Module—10 Laurie Brimmer, other countries and current pulmonary Senior Tax Analyst. minutes. function. Data on deployment locations, Non-OEF/OIF/OND Exposure [FR Doc. 2018–07967 Filed 4–16–18; 8:45 am] exposures while deployed, current Module—10 minutes. BILLING CODE 4830–01–P pulmonary function and several Civilian Occupation and Hobby important covariates are not available Exposure Module—5 minutes. and will need to be collected from Health, Smoking, and Demographics DEPARTMENT OF VETERANS participants. This research study will Module—15 minutes. AFFAIRS generate data which will be used to Medication and Dietary Supplement assist VA in obtaining information that [OMB Control No. 2900—NEW] Module—10 minutes. can be used to improve health care for Participant Status Check-In Module— Agency Information Collection Veterans. 5 minutes. Activity: Pulmonary Health and An agency may not conduct or Spirometry—35 minutes. Deployment to Southwest Asia and sponsor, and a person is not required to Medical History Module—5 minutes. Afghanistan respond to a collection of information Functional Health Module—4 unless it displays a currently valid OMB minutes. AGENCY: Veterans Health control number. The Federal Register Health Symptoms Module—3 Administration, Department of Veterans Notice with a 60-day comment period minutes. Affairs. soliciting comments on this collection Current Mood Module—5 minutes. ACTION: Notice. of information was published at 83 FR Participant Feedback Module—3 2876 on January 19, 2018, pages 2876– minutes. SUMMARY: In compliance with the 2877. Post-Visit Feedback Module—10 Paperwork Reduction Act (PRA) of Affected Public: Individuals and minutes. 1995, this notice announces that the households. Frequency of Response: Annually. Veterans Health Administration, Estimated Annual Burden: Estimated Number of Respondents: Department of Veterans Affairs, will Recruitment Screening Module—517 Recruitment Screening Module— submit the collection of information hours. 6200.

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Spirometry Screening Module—6200. (FDMS) at www.Regulations.gov or to Frequency of Response: On occasion. Military Overview Module—6200. Nancy J. Kessinger, Veterans Benefits Estimated Number of Respondents: OEF/OIF/OND Location Module— Administration (20M33), Department of 36,000. 6200. Veterans Affairs, 810 Vermont Avenue By direction of the Secretary. Non-OEF/OIF/OND Location NW, Washington, DC 20420 or email to Cynthia D. Harvey-Pryor, Module—6200. [email protected]. Please refer to OEF/OIF/OND Exposure Module– ‘‘OMB Control No. 2900–0744’’ in any Department Clearance Officer, Office of Quality, Privacy and Risk, Department of 6200. correspondence. During the comment Veterans Affairs. Non-OEF/OIF/OND Exposure period, comments may be viewed online [FR Doc. 2018–07949 Filed 4–16–18; 8:45 am] Module—6200. through the FDMS. BILLING CODE 8320–01–P Civilian Occupation and Hobby FOR FURTHER INFORMATION CONTACT: Exposure Module—6200. Cynthia D. Harvey-Pryor at (202) 461– Health, Smoking, and Demographics 5870. DEPARTMENT OF VETERANS Module—6200. SUPPLEMENTARY INFORMATION: Under the AFFAIRS Medication and Dietary Supplement PRA of 1995, Federal agencies must Module—6200. [OMB Control No. 2900—NEW] obtain approval from the Office of Participant Status Check-In Module– Management and Budget (OMB) for each 6200. Agency Information Collection collection of information they conduct Spirometry—6200. Activity: Federal Medical Care or sponsor. This request for comment is Medical History Module—6200. Recovery Act Bill Requests being made pursuant to the PRA. Functional Health Module—6200. With respect to the following AGENCY: Veterans Health Health Symptoms Module—6200. collection of information, VBA invites Administration, Department of Veterans Current Mood Module—6200. comments on: (1) Whether the proposed Affairs. Participant Feedback Module—6200. collection of information is necessary ACTION: Notice. Post-Visit Feedback Module—310. for the proper performance of VBA’s By direction of the Secretary. functions, including whether the SUMMARY: Veterans Health Cynthia D. Harvey-Pryor, information will have practical utility; Administration, Department of Veterans Department Clearance Officer, Office of (2) the accuracy of VBA’s estimate of the Affairs (VA), is announcing an Quality, Privacy and Risk, Department of burden of the proposed collection of opportunity for public comment on the Veterans Affairs. information; (3) ways to enhance the proposed collection of certain [FR Doc. 2018–07952 Filed 4–16–18; 8:45 am] quality, utility, and clarity of the information by the agency. Under the BILLING CODE 8320–01–P information to be collected; and (4) Paperwork Reduction Act (PRA) of ways to minimize the burden of the 1995, Federal agencies are required to collection of information on publish notice in the Federal Register DEPARTMENT OF VETERANS respondents, including through the use concerning each proposed collection of AFFAIRS of automated collection techniques or information, including each proposed the use of other forms of information [OMB Control No. 2900–0744] new collection, and allow 60 days for technology. public comment in response to the Agency Information Collection Authority: The Government notice. Performance and Results Act of 1993, Activity: VBA Call Center Satisfaction DATES: Written comments and Survey Public Law 103–62. August 3, 1993 and Title 38 U.S.C., § 527, Evaluation and recommendations on the proposed AGENCY: Veterans Benefits Data Collection; 5 CFR 1320: Section collection of information should be Administration, Department of Veterans 3506(c)(2)(A) of received on or before June 18, 2018. Affairs. Title: VBA Call Center Satisfaction ADDRESSES: Submit written comments ACTION: Notice. Survey. on the collection of information through OMB Control Number: 2900–0744. Federal Docket Management System SUMMARY: The Veterans Benefits Type of Review: Revision of a (FDMS) at www.Regulations.gov or to Administration (VBA), Department of currently approved collection. Brian McCarthy, Office of Regulatory Veterans Affairs (VA), is announcing an Abstract: VBA maintains a and Administrative Affairs (10B4), opportunity for public comment on the commitment to improve the overall Department of Veterans Affairs, 810 proposed collection of certain quality of service for Veterans. Feedback Vermont Avenue NW, Washington, DC information by the agency. Under the from Veterans regarding their recent 20420 or email to Brian.McCarthy4@ Paperwork Reduction Act (PRA) of experience to the VA call centers will va.gov. Please refer to ‘‘OMB Control 1995, Federal agencies are required to provide VBA with three key benefits to: No. 2900—NEW’’ in any publish notice in the Federal Register (1) Identify what is most important to correspondence. During the comment concerning each proposed collection of Veterans; (2) determine what to do to period, comments may be viewed online information, including each proposed improve the call center experience; and through FDMS. (3) serve to guide training and/or revision of a currently approved FOR FURTHER INFORMATION CONTACT: operational activities aimed at collection, and allow 60 days for public Brian McCarthy at (202) 615–9241. comment in response to the notice. enhancing the quality of service provided to Veterans and active duty SUPPLEMENTARY INFORMATION: Under the DATES: Written comments and personnel. PRA of 1995, Federal agencies must recommendations on the proposed Affected Public: Individuals or obtain approval from the Office of collection of information should be households. Management and Budget (OMB) for each received on or before June 18, 2018. Estimated Annual Burden: 3,600 collection of information they conduct ADDRESSES: Submit written comments hours. or sponsor. This request for comment is on the collection of information through Estimated Average Burden per being made pursuant to Section 3506 of Federal Docket Management System Respondent: 6 minutes. the PRA.

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With respect to the following By direction of the Secretary. DATES: Comments should be submitted collection of information, VHA invites Cynthia D. Harvey-Pryor, within 30 days from when this comments on: (1) Whether the proposed Department Clearance Officer, Office of announcement is published in the collection of information is necessary Quality, Privacy and Risk, Department of Federal Register. for the proper performance of VHA’s Veterans Affairs. ADDRESSES: Written comments may be functions, including whether the [FR Doc. 2018–07947 Filed 4–16–18; 8:45 am] submitted by email through http:// information will have practical utility; BILLING CODE 8320–01–P www.regulations.gov. Comments should (2) the accuracy of VHA’s estimate of indicate that they are submitted in the burden of the proposed collection of response to ‘‘Notice of availability and information; (3) ways to enhance the DEPARTMENT OF VETERANS request for comments—Programmatic quality, utility, and clarity of the AFFAIRS Consideration of Historic Properties in information to be collected; and (4) Transfer of Property Rights of Vacant ways to minimize the burden of the Programmatic Consideration of and Underutilized Buildings, Structures collection of information on Historic Properties in Transfer of and Land.’’ During the comment period, respondents, including through the use Property Rights of Vacant and comments may be viewed online of automated collection techniques or Underutilized Buildings, Structures through the Federal Docket Management the use of other forms of information and Land System at http://www.regulations.gov. technology. AGENCY: Department of Veterans Affairs. FOR FURTHER INFORMATION CONTACT: Authority: 38 U.S.C. 501, 38 CFR Douglas Pulak, Federal Preservation ACTION: Notice of availability and 1.900 et seq.; 42 U.S.C. 2651–2653; 38 Officer (003C2), Department of Veterans request for comment. U.S.C. 1729; 28 CFR 43.2; and E.O. Affairs, 810 Vermont Avenue NW, 9397. Washington, DC 20420. SUMMARY: The Department of Veterans SUPPLEMENTARY INFORMATION: Section Title: Federal Medical Care Recovery Affairs (VA) is reviewing its capital 106 of the National Historic Act Bill Requests; Request for VA asset inventory and identifying vacant Preservation Act (54 U.S.C. 306108) Billing, CHAMPVA Request for Billing. and underutilized buildings, structures requires Federal agencies to take into and land. VA may consider sales, public OMB Control Number: 2900—NEW. account the effects of their undertakings benefit conveyances, demolition and Type of Review: New collection. on historic properties and provide deconstruction to reduce its unneeded ACHP a reasonable opportunity to Abstract: The purpose of collecting real property. Additionally, VA may comment with regard to such this information is to provide basic consider leases and exchanges to non- undertakings. ACHP regulations, information from which potential Federal entities for potential reuse of codified at 36 CFR part 800, set forth the liability can be assessed for VA to vacant and underutilized buildings and process by which Federal agencies recover the cost of care from the liable structures. This announcement pertains comply with NHPA requirements. party instead of the American taxpayer to an alternative process VA may utilize and Veteran paying for the care. Failure Under Section 800.14(e), Federal to comply with the requirements of the agencies may request ACHP to provide to provide any or all of the requested National Historic Preservation Act information may delay or result in VA’s a Program Comment on a particular (NHPA). program and category of undertakings in inability to create accident-related The Advisory Council on Historic billing, assert a claim for lieu of conducting individual reviews of Preservation (ACHP) is a Federal agency each individual undertaking as set forth reimbursement, and assist the Veteran tasked with review of other Federal in their personal injury or workers in 36 CFR Sections 800.4 through 800.6. agencies’ compliance with NHPA and A Federal agency can meet its Section compensation claim. Without a third the implementing regulations. VA party paying for the care, the Veteran 106 responsibilities for a category of intends to request ACHP to consider a undertakings by taking into account may owe VA copayments. With regards Program Comment for the entire to the CHAMPVA form alone: Failure to ACHP’s Program Comment and by program of reduction of vacant and following the steps set forth in those provide any or all of the requested underutilized properties. ACHP may information may delay or result in VA’s comments. agree or decline to consider VA’s To initiate this process, VA intends to inability to provide CHAMPVA benefits. Program Comment request. If ACHP request ACHP to consider a Program Affected Public: Individuals and does issue a Program Comment in lieu Comment for its program to reduce its households. of case-by-case review, this alternative real property inventory of vacant and Estimated Annual Burden: will conserve VA’s time, budget and underutilized properties at VA Medical staff resources. It will enable VA to Request for VA Billing—385 hours. Centers and National Cemeteries transfer real property rights of the nationwide. VA intends the program CHAMPVA Request for Billing—303 vacant and underutilized properties comment to ACHP will encompass a hours. more quickly while still giving variety of real estate actions such as Estimated Average Burden per consideration to historic properties as leases (including both Enhanced-Use Respondent: required by NHPA. Leases under VA’s authority at 38 U.S.C. Request for VA Billing—7 minutes. This Notice of Availability announces 8161–8169, and NHPA Section 111 and invites public involvement in the leases authorized under 16 U.S.C. 470h– CHAMPVA Request for Billing—7 process of development of the Program 3), exchanges, sales, transfers, minutes. Comment for consideration of historic deconstruction and demolition of Frequency of Response: Annually. properties that are vacant and buildings and structures. ACHP will Estimated Number of Respondents: underutilized buildings, structures and decide whether to issue a Program land that may be historic properties. Comment to VA or decline. If ACHP Request for VA Billing—3,300. Historic properties are those listed on decides to issue the Program Comment, CHAMPVA Request for Billing— the National Register of Historic Places they will publish a draft in the Federal 2,600. or eligible for such listing. Register for public review and

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comment. Following consideration of Dated: April 11, 2018. or sponsor. This request for comment is such comments by ACHP and VA, the Jeffrey M. Martin, being made pursuant to of the PRA. final Program Comment will be Impact Analyst, Office of Regulation Policy With respect to the following published in the Federal Register. & Management, Office of the Secretary, collection of information, VBA invites VA initiated the identification of Department of Veterans Affairs. comments on: (1) Whether the proposed historic properties in its capital asset [FR Doc. 2018–07958 Filed 4–16–18; 8:45 am] collection of information is necessary inventory several decades ago. VA BILLING CODE 8320–01–P for the proper performance of VBA’s identified, in consultation with State functions, including whether the Historic Preservation Offices, information will have practical utility; approximately 65 percent of the medical DEPARTMENT OF VETERANS (2) the accuracy of VBA’s estimate of the centers as having some buildings and AFFAIRS burden of the proposed collection of structures, or districts eligible or listed information; (3) ways to enhance the [OMB Control No. 2900–0074] on the National Register of Historic quality, utility, and clarity of the information to be collected; and (4) Places. All of the National Veterans Agency Information Collection Cemeteries are listed on the National ways to minimize the burden of the Activity: Request for Change of collection of information on Register. The development of VA and its Program or Place of Training historic role in the care and treatment of respondents, including through the use veterans over time is significant in the AGENCY: Veterans Benefits of automated collection techniques or history of the United States. Administration, Department of Veterans the use of other forms of information Affairs. technology. The analysis of buildings and Authority: Public Law 104–13; 44 ACTION: Notice. structures that are no longer needed or U.S.C. 3501–21; 5 CFR 1320, Section cannot be adapted for current use will SUMMARY: 3506(c)(2)(A). aid VA in reducing its real property The Veterans Benefits Administration (VBA), Department of Title: Request for Change of Program inventory. Many buildings and or Place of Training (VA Form 22–1995). structures are not useful for VA’s Veterans Affairs (VA), is announcing an opportunity for public comment on the OMB Control Number: 2900–0074. mission. In general, they tend to be Type of Review: Extension of an warehouses, garages, sheds, animal proposed collection of certain information by the agency. Under the approved collection. research structures, and other utilitarian Abstract: VA Form 22–1995 is used to buildings. Most of these types of Paperwork Reduction Act (PRA) of 1995, Federal agencies are required to determine the applicant’s continued buildings and structures are not eligible eligibility to educational assistance or contributing to a historic district. VA publish notice in the Federal Register concerning each proposed collection of administered by VA after a change in intends to propose deconstruction or training or the place where training is demolition of these properties without information, including each proposed extension of a currently approved pursued. further consideration under the Program Affected Public: Individuals or Comment. collection, and allow 60 days for public comment in response to the notice. households. For buildings, structures and land that The VA Form 22–1995 is used to Estimated Annual Burden: 57,009 may serve other non-Federal entities determine the applicant’s continued hours. purpose, VA may be able to out lease eligibility to educational assistance Estimated Average Burden per them. The leases would contain specific administered by VA after a change in Respondent: 15 minutes (Electronic) 20 requirements for treatment of the training or the place where training is minutes (Paper). character defining features of the pursued. Frequency of Response: One time. historic property if the lessee is Estimated Number of Respondents: pursuing tax credits for rehabilitation of DATES: Written comments and 184,894. recommendations on the proposed the historic property. For all other leases By direction of the Secretary. of historic properties, the reuse proposal collection of information should be Cynthia D. Harvey-Pryor, would be evaluated with the lessee for received on or before June 18, 2018. potential retention of any character ADDRESSES: Submit written comments Department Clearance Officer, Office of on the collection of information through Quality, Privacy and Risk, Department of defining features such as windows, Veterans Affairs. entry spaces, staircases and historic Federal Docket Management System [FR Doc. 2018–07948 Filed 4–16–18; 8:45 am] landscaping. If it is not possible to (FDMS) at www.Regulations.gov or to retain significant historic features of a Nancy J. Kessinger, Veterans Benefits BILLING CODE 8320–01–P building or structure, they will be Administration (20M33), Department of Veterans Affairs, 810 Vermont Avenue documented prior to removal or DEPARTMENT OF VETERANS NW, Washington, DC 20420 or email to alteration. AFFAIRS [email protected]. Please refer to Signing Authority ‘‘OMB Control No. 2900–0074’’ in any [OMB Control No. 2900–0790] correspondence. During the comment The Secretary of Veterans Affairs, or Agency Information Collection designee, approved this document and period, comments may be viewed online through the FDMS. Activity: Application and Reporting authorized the undersigned to sign and Requirements To Receive Grants submit the document to the Office of the FOR FURTHER INFORMATION CONTACT: Federal Register for publication Nancy J. Kessinger at (202) 632–8924 or AGENCY: Veterans Health electronically as an official document of FAX (202) 632–8925. Administration, Department of Veterans the Department of Veterans Affairs. SUPPLEMENTARY INFORMATION: Under the Affairs Jacquelyn Hayes-Byrd, Deputy Chief of PRA of 1995, Federal agencies must ACTION: Notice. Staff, Department of Veterans Affairs, obtain approval from the Office of approved this document on April 11, Management and Budget (OMB) for each SUMMARY: Veterans Health 2018, for publication. collection of information they conduct Administration, Department of Veterans

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Affairs (VA), is announcing an 307) requires VA to establish a program collection of information should be opportunity for public comment on the to provide grants to eligible entities to received on or before June 18, 2018. proposed collection of certain assist veterans in highly rural areas ADDRESSES: Submit written comments information by the agency. Under the through innovative transportation on the collection of information through Paperwork Reduction Act (PRA) of services to travel to VA medical centers, the Federal Docket Management System 1995, Federal agencies are required to and to otherwise assist in providing (FDMS) at www.Regulations.gov; or to publish notice in the Federal Register transportation services in connection Brian McCarthy, Office of Regulatory concerning each proposed collection of with the provision of VA medical care and Administrative Affairs, Veterans information, including each proposed to these veterans. Paragraph (a) of Health Administration (10B4), extension of a currently approved section 307 mandates that VA will Department of Veterans Affairs, 810 collection, and allow 60 days for public award grants to eligible entities for these Vermont Avenue NW, Washington, DC comment in response to the notice. purposes, and paragraph (b) of section 20420 or email: Brian.McCarthy4@ DATES: Written comments and 307 mandates that VA will establish va.gov. Please refer to ‘‘OMB Control recommendations on the proposed procedures for evaluating grant No. 2900–0793’’ in any correspondence. collection of information should be applications. This collection of During the comment period, comments received on or before June 18, 2018. information is necessary to fulfill VA’s may be viewed online through FDMS. ADDRESSES: Submit written comments obligations under section 307. FOR FURTHER INFORMATION CONTACT: on the collection of information through Affected Public: Individuals and Brian McCarthy at (202) 461–6345. Federal Docket Management System households. SUPPLEMENTARY INFORMATION: Under the (FDMS) at www.Regulations.gov or to Estimated Annual Burden: 200 hours. PRA of 1995, Federal agencies must Brian McCarthy, Office of Regulatory Estimated Average Burden per obtain approval from OMB for each and Administrative Affairs (10B4), Respondent: 111 minutes. collection of information they conduct Department of Veterans Affairs, 810 Frequency of Response: Annually. or sponsor. This request for comment is Estimated Number of Respondents: Vermont Avenue NW, Washington, DC being made pursuant to Section 100. 20420 or email to Brian.McCarthy4@ 3506(c)(2)(A) of the PRA. va.gov. Please refer to ‘‘OMB Control By direction of the Secretary. With respect to the following No. 2900–0790’’ in any correspondence. Cynthia D. Harvey-Pryor, collection of information, VHA invites During the comment period, comments Department Clearance Officer, Office of comments on: (1) Whether the proposed may be viewed online through FDMS. Quality, Privacy and Risk, Department of collection of information is necessary FOR FURTHER INFORMATION CONTACT: Veterans Affairs. for the proper performance of VHA’s Brian McCarthy at (202) 461–6345. [FR Doc. 2018–07951 Filed 4–16–18; 8:45 am] functions, including whether the SUPPLEMENTARY INFORMATION: Under the BILLING CODE 8320–01–P information will have practical utility; PRA of 1995, Federal agencies must (2) the accuracy of VHA’s estimate of obtain approval from the Office of the burden of the proposed collection of DEPARTMENT OF VETERANS Management and Budget (OMB) for each information; (3) ways to enhance the AFFAIRS collection of information they conduct quality, utility, and clarity of the or sponsor. This request for comment is [OMB Control No. 2900–0793] information to be collected; and (4) being made pursuant to Section 3506 of ways to minimize the burden of the the PRA. Agency Information Collection collection of information on With respect to the following Activity: VA Health Professional respondents, including through the use collection of information, VHA invites Scholarship and Visual Impairment of automated collection techniques or comments on: (1) Whether the proposed and Orientation and Mobility the use of other forms of information collection of information is necessary Professional Scholarship Programs technology. for the proper performance of VHA’s Authority: Public Law 104–13; 44 AGENCY: Veterans Health functions, including whether the U.S.C. 3501–3521. Administration, Department of Veterans Titles: information will have practical utility; Affairs. 1. Academic Verification, VA Form (2) the accuracy of VHA’s estimate of ACTION: Notice. 10–0491. the burden of the proposed collection of 2. Addendum to Application, VA information; (3) ways to enhance the SUMMARY: The Veterans Health Form 10–0491a. quality, utility, and clarity of the Administration (VHA) is announcing an 3. Annual VA Employment Deferment information to be collected; and (4) opportunity for public comment on the Verification, VA Form 10–0491c ways to minimize the burden of the proposed collection of certain 4. Education Program Completion collection of information on information by the agency. Under the Notice Service Obligation Placement, respondents, including through the use Paperwork Reduction Act (PRA) of VA Form 10–0491d of automated collection techniques or 1995, Federal agencies are required to 5. Evaluation Recommendation Form, the use of other forms of information publish notice in the Federal Register VA Form 10–0491e technology. concerning each proposed collection of 6. HPSP Agreement, VA Form 10– Authority: Public Law 111–163 information, including each proposed 0491f Section 307. revision of a currently approved 7. HPSP/OMPSP Application, VA Title: Application and Reporting collection, and allow 60 days for public Form 10–0491g Requirements to Receive Grants under 8. Notice of Approaching Graduation, comment in response to the notice. This 38 CFR 17.703; VA Form 10–10055, VA VA Form 10–0491h notice solicits comments on information Form 10–10056. 9. Notice of Change and/or Annual needed to identify areas for OMB Control Number: 2900–0790. Academic Status Report, VA Form 10– Type of Review: New collection. improvement in clinical training 0491i Abstract: Section 307 of Title III of the programs. 10. Request for Deferment for Caregivers and Veterans Omnibus DATES: Written comments and Advanced Education, VA Form 10– Health Services Act of 2010 (section recommendations on the proposed 0491j

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11. VA Scholarship Offer Response, through 7619, and 38 U.S.C. 7501 United States. The Visual Impairment VA Form 10–0491k through 7505. The information is and Orientation and Mobility 12. VIOMPSP Agreement, VA Form needed to apply for the VA Health Professional Scholarship Program 10–0491l Professional Scholarship Program or awards scholarships to students 13. Mobility Agreement, VA Form 10– Visual Impairment and Orientation and pursuing a program of study leading to 0491m Mobility Professional Scholarship a degree in visual impairment or OMB Control Number: 2900–0793. Program. The VA Health Professional orientation and mobility in order to Type of Review: Revision of a increase the supply of qualified blind currently approved collection. Scholarship Program awards scholarships to students receiving rehabilitation specialists for VA and the Abstracts: Nation. The information required determines education or training in a direct or the eligibility or suitability of an indirect healthcare services discipline to Affected Public: Individuals or applicant desiring to receive an award assist in providing an adequate supply households. under the provisions of 38 U.S.C. 7601 of such personnel for VA and for the Estimated Burden:

APPLICANTS

# of × # of × # of Equals ÷ by Number VA Forms respondents responses Equals minutes (minutes) 60 = of hours

10–0491g—Application 1,500 1 1,500 60 90,000 ...... 1,500 10–0491—Academic Verification ...... 1,500 1 1,500 60 90,000 ...... 1,500 10–0491e—Evaluation & Recommendation .. 1,500 2 3,000 50 150,000 ...... 2,500 10–0491a—Addendum to Application ...... 450 (30%) 1 450 10 4,500 ...... 75

Total ...... 5,575

APPLICANTS SELECTED TO RECEIVE A SCHOLARSHIP

# of × # of × # of Equals ÷ by Number VA Forms respondents responses Equals minutes (minutes) 60 = of hours

10–0491m—Mobility Agreement ...... 30 1 30 10 300 ...... 5 10–0491L—Agreement for the VIOMPSP ...... 30 1 30 15 450 ...... 8 10–0491k—VA Scholar- ship Offer Response 30 1 30 10 300 ...... 5 10–0491i—Notice of Change and/or An- nual Academic Status Report ...... 30 1 30 20 600 ...... 10 10–0491h—Notice of Approaching Gradua- tion ...... 30 1 30 10 300 ...... 5 10–0491d—Education Program Completion Notice/Service Obli- gation Placement ...... 30 1 30 20 600 ...... 10 10–0491j—Request for Deferment for Ad- vanced Education ..... 6 1 6 10 60 ...... 1 10–0491c—Annual VA Employment/ Deferment Verification ...... 30 1 24 10 240 ...... 4

Total ...... 48

Grand Total for VIOMPSP ...... 5,623

HEALTH PROFESSIONAL SCHOLARSHIP PROGRAM (HPSP) APPLICANTS

# of × # of × # of Equals ÷ by Number VA Forms respondents responses Equals minutes (minutes) 60 = of hours

10–0491g—Application 5,000 1 5,000 60 300,000 ...... 5,000

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HEALTH PROFESSIONAL SCHOLARSHIP PROGRAM (HPSP) APPLICANTS—Continued

# of × # of × # of Equals ÷ by Number VA Forms respondents responses Equals minutes (minutes) 60 = of hours

10–0491—Academic Verification ...... 5,000 1 5,000 60 300,000 ...... 5,000 10–0491e—Evaluation & Recommendation .. 5,000 2 10,000 50 500,000 ...... 8,333 10–0491a—Addendum to Application ...... 1500 (30%) 1 1500 10 15,000 ...... 250

Total ...... 18,583

APPLICANTS SELECTED TO RECEIVE A SCHOLARSHIP

# of × # of × # of Equals ÷ by Number VA Forms respondents responses Equals minutes (minutes) 60 = of hours

10–0491m—Mobility Agreement ...... 100 1 100 10 1,000 ...... 17 10–0491f—Agreement for the HPSP ...... 100 1 100 15 1,500 ...... 25 10–0491k—VA Scholar- ship Offer Response 100 1 100 10 1,000 ...... 17 10–0491i—Notice of Change and/or An- nual Academic Status Report ...... 100 1 100 20 2,000 ...... 33 10–0491h—Notice of Approaching Gradua- tion ...... 100 1 100 10 1,000 ...... 17 10–0491d—Education Program Completion Notice/Service Obli- gation Placement ...... 100 1 100 20 2,000 ...... 33 10–0491j—Request for Deferment for Ad- vanced Education ..... 20 1 20 10 200 ...... 3 10–0491c—Annual VA Employment/ Deferment Verification ...... 80 1 80 10 800 ...... 13

Total ...... 158

Grand Total for HPSP ...... 18,741

Grand Total for Both VIOMP- SP and HPSP ...... 24,364

Frequency of Response: Annually. By direction of the Secretary. Cynthia D. Harvey-Pryor, Department Clearance Officer, Office of Quality, Privacy and Risk, Department of Veterans Affairs. [FR Doc. 2018–07950 Filed 4–16–18; 8:45 am] BILLING CODE 8320–01–P

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Part II

Department of Health and Human Services

45 CFR Parts 147, 153, 154, et al. Patient Protection and Affordable Care Act; HHS Notice of Benefit and Payment Parameters for 2019; Final Rule

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DEPARTMENT OF HEALTH AND Emily Ames, (301) 492–4246, for G. Part 158—Issuer Use of Premium HUMAN SERVICES matters related to Navigators and non- Revenue: Reporting and Rebate Navigator assistance personnel. Requirements 45 CFR Parts 147, 153, 154, 155, 156, Elissa Dines, (301) 492–4388, for IV. Collection of Information Requirements 157, and 158 A. Wage Estimates matters related to employer-sponsored B. ICRs Regarding State Flexibility for Risk coverage verification. Adjustment [CMS–9930–F] Kendra May, (301) 492–4477, for C. ICRs Regarding Risk Adjustment Data matters related to the requirement to file Validation RIN 0938–AT12 an income tax return and reconcile D. ICRs Regarding Health Insurance Issuer Patient Protection and Affordable Care APTC and terminations. Rate Increases: Disclosure and Review Carolyn Kraemer, (301) 492–4197, for Requirements—Applicability Act; HHS Notice of Benefit and E. ICRs Regarding Rate Increases Subject Payment Parameters for 2019 matters related to special enrollment periods under part 155. To Review F. ICRs Regarding the Small Business AGENCY: Centers for Medicare & Amanda Brander, (202) 690–7892, for Health Options Program Medicaid Services (CMS), HHS. matters related to exemptions from the G. ICRs Regarding Essential Health Benefits ACTION: Final rule. individual shared responsibility H. ICRs Regarding Medical Loss Ratio payment. I. Summary of Annual Burden Estimates SUMMARY: This final rule sets forth Terence Kane, (301) 492–4449, for for Final Requirements payment parameters and provisions matters related to income J. Submission of PRA-Related Comments related to the risk adjustment and risk inconsistencies. V. Regulatory Impact Analysis adjustment data validation programs; Jacob Schnur, (410) 786–7703, for A. Statement of Need cost-sharing parameters; and user fees matters related to direct enrollment. B. Overall Impact C. Impact Estimates of the Payment Notice for Federally-facilitated Exchanges and Laura Eldon, (301) 492–4372, for Provisions and Accounting Table State Exchanges on the Federal matters related to the Federally- D. Regulatory Alternatives Considered platform. It finalizes changes that facilitated SHOP. E. Regulatory Flexibility Act provide additional flexibility to States to Shilpa Gogna, (301) 492–4257, for F. Unfunded Mandates apply the definition of essential health matters related to SHOP in State G. Federalism benefits (EHB) to their markets, enhance Exchanges. H. Congressional Review Act the role of States regarding the Leigha Basini, (301) 492–4380, I. Reducing Regulation and Controlling certification of qualified health plans Rebecca Zimmermann, (301) 492–4396, Regulatory Costs (QHPs); and provide States with or Allison Yadsko, (410) 786–1740, for I. Executive Summary additional flexibility in the operation matters related to standardized options, American Health Benefit Exchanges, and establishment of Exchanges, essential health benefits, stand-alone or ‘‘Exchanges’’ (also called including the Small Business Health dental plans and other standards for ‘‘Marketplaces’’) are entities established Options Program (SHOP) Exchanges. It QHP issuers. under the Patient Protection and includes changes to standards related to Cam Moultrie Clemmons, (206) 615– Affordable Care Act (PPACA) through Exchanges; the required functions of the 2338, for matters related to minimum which qualified individuals and SHOPs; actuarial value for stand-alone essential coverage. qualified employers can purchase health dental plans; the rate review program; Christina Whitefield, (301) 492–4172, insurance coverage. Many individuals the medical loss ratio program; for matters related to the medical loss who enroll in qualified health plans eligibility and enrollment; exemptions; ratio program. (QHPs) through individual market and other related topics. SUPPLEMENTARY INFORMATION: Exchanges are eligible to receive a DATES: Effective Date: These regulations Table of Contents premium tax credit (PTC) to reduce are effective on June 18, 2018. their costs for health insurance FOR FURTHER INFORMATION CONTACT: I. Executive Summary II. Background premiums, and receive reductions in Lindsey Murtagh, (301) 492–4106, A. Legislative and Regulatory Overview required cost-sharing payments to Rachel Arguello, (301) 492–4263, Alper B. Stakeholder Consultation and Input reduce out-of-pocket expenses for health Ozinal, (301) 492–4178, or Abigail C. Structure of Final Rule care services. The PPACA also Walker, (410) 786–1725, for general III. Provisions of the Proposed Rule and established the risk adjustment program, information. Analysis of and Responses to Public which is intended to mitigate the Krutika Amin, (301) 492–5153, for Comments potential impact of adverse selection matters related to risk adjustment, and A. Part 147—Health Insurance Reform and stabilize the price of health user fees for Federally-facilitated Requirements for the Group and insurance in the individual and small Exchanges and State-Exchanges on the Individual Health Insurance Markets B. Part 153—Standards Related to group markets, both on and off Federal platform. Reinsurance, Risk Corridors, and Risk Exchanges. Adrianne Patterson, (410) 786–0686, Adjustment Under the Affordable Care Over time, issuer exits and increasing or Abigail Walker, (410) 786–1725, for Act insurance premiums have threatened matters related to sequestration. C. Part 154—Health Insurance Issuer Rate the stability of the individual and small Melissa Jaffe, (301) 492–4129, for Increases: Disclosure and Review group Exchanges in many geographic matters related to risk adjustment data Requirements areas. In previous rulemaking, we validation, cost-sharing reductions, and D. Part 155—Exchange Establishment established provisions and parameters the premium adjustment percentage. Standards and Other Related Standards to implement many PPACA provisions Lisa Cuozzo, (410) 786–1746, for Under the Affordable Care Act and programs. In this final rule, we E. Part 156—Health Insurance Issuer matters related to rate review. Standards Under the Affordable Care amend these provisions and parameters, Jenny Chen, (301) 492–5156, for Act, Including Standards Related to with a focus on enhancing the role of matters related to establishing a State Exchanges States in these programs and providing Exchange, and State Exchanges on the F. Part 157—Employer Interactions With States with additional flexibilities, Federal platform. Exchanges and SHOP Participation reducing unnecessary regulatory burden

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on stakeholders, empowering changes would allow for a more constraints, we are changing the consumers, and improving affordability. efficient SHOP, such that employers and requirements regarding Navigators, and On January 20, 2017, the President employees could enroll in SHOP the requirements regarding non- issued an Executive Order which stated coverage by working with a QHP issuer Navigator assistance personnel subject that, to the maximum extent permitted or SHOP-registered agent or broker. to § 155.215, to enable Exchanges to by law, the Secretary of HHS and heads Additionally, the finalized policies more easily operate these programs with of all other executive departments and provide States more flexibility regarding limited resources. Similarly, we are agencies with authorities and risk adjustment transfers in their allowing an agent, broker or issuer responsibilities under the PPACA markets. We also make it easier for participating in direct enrollment to should exercise all authority and States to apply for and be granted an have its selected third-party entity discretion available to them to waive, adjustment to the individual market conduct operational readiness reviews, defer, grant exemptions from, or delay medical loss ratio (MLR) standard in rather than requiring that those reviews the implementation of any provision or their State. We believe this change be conducted by entities approved by requirement of the PPACA that would provides States with an additional tool HHS. impose a fiscal burden on any State or to help stabilize, innovate and provide We also finalize relatively minor a cost, fee, tax, penalty, or regulatory relief in their individual markets. adjustments to our programs and rules burden on individuals, families, health Additionally, we make other changes to as we do each year in the HHS notice care providers, health insurers, patients, the MLR program to reduce the burden of benefit and payment parameters. We recipients of health care services, on issuers. are finalizing a number of incremental purchasers of health insurance, or Risk adjustment continues to be a core amendments to our policies around makers of medical devices, products, or program for stabilizing the individual coverage, eligibility, enrollment, and medications. In this rule, within the and small group markets both on and off affordability exemptions. limitations of the current statute, we are Exchanges, and we are finalizing We continue to be very interested in finalizing policies to reduce fiscal and recalibrated parameters for the HHS risk exploring ways to improve Exchange regulatory burdens across different adjustment methodology. We are also program integrity. In the proposed rule, program areas, and to support finalizing several changes related to the we sought comment on a number of innovative health insurance models. risk adjustment data validation program program integrity items, including We are finalizing several changes that that are intended to ensure the integrity whether we should consider shortening would significantly expand the role of of the results of risk adjustment, while the length of time the Exchanges are States in the administration of the alleviating issuer burden. authorized to obtain enrollee tax PPACA. We received comments on As we do every year in the HHS information, as well as ways to prompt additional ways to support State notice of benefit and payment more timely consumer reporting of Exchanges (SBEs) in adopting parameters final rule, we are finalizing changes in circumstances during the innovative approaches to operating and updated parameters applicable in the benefit year that may impact an sustaining their Exchanges, and to make individual and small group markets. We individual’s eligibility for coverage and the State Exchange on the Federal are finalizing the user fee rate for issuers financial assistance. In addition, we platform (SBE–FP) model a more participating on FFEs and SBE–FPs for requested comment on any additional appealing and viable model for States. 2019 to be 3.5 and 3.0 percent of program integrity improvements that We finalize policies under which States premiums, respectively. We are were not outlined in the proposed rule, assume a larger role in reviewing the finalizing the premium adjustment but could be beneficial in a future QHP certification standards of network percentage for 2019, which is used to set rulemaking. adequacy and essential community the rate of increase for several Finally, as noted in the proposed rule, providers for the Federally-facilitated parameters detailed in the PPACA, we intend to consider proposals in Exchanges (FFEs). This will confirm including the maximum annual future rulemaking that would help States’ traditional role in overseeing limitation on cost sharing for 2019, the reduce drug costs and promote drug their health insurance markets, and required contribution percentage used price transparency. We also intend to reduce the issuer burden associated to determine eligibility for certain provide guidance on other aspects of with having to comply with duplicative exemptions under section 5000A of the Exchange eligibility in the near future. State and Federal reviews. Internal Revenue Code of 1986 (the In particular, we intend to reconsider This rule also finalizes several Code), and the assessable payment the appropriate thresholds for changes policies that will provide States with amounts under section 4980H(a) and (b) in income that will trigger a data greater flexibility. For example, this rule of the Code. We are finalizing updates matching inconsistency, processes for provides States with additional to the maximum annual limitations on denying eligibility for advance subsidies flexibility in applying the definition of cost sharing for the 2019 benefit year for for individuals who fail to reconcile EHBs to their markets starting with the cost-sharing reductions plan variations. advance payments of the premium tax 2020 plan year. In addition to granting We are finalizing a number of changes credit (APTC) on their Federal income States more flexibility regulating their related to rate review that are intended tax return, processes for matching markets, we believe this change would to reduce regulatory burden on States enrollment data with the Medicare and permit States to modify EHBs to and issuers in regard to the rate filing Medicaid programs in order to help increase affordability of health process. Specifically, we are exempting consumers avoid duplicate enrollments, insurance in the individual and small student health insurance coverage from and the appropriate manner of group markets. This rule also provides Federal rate review requirements, recalculating APTC following a midyear States with significantly more flexibility beginning with coverage effective on or change in eligibility, and sought in how they operate a Small Business after July 1, 2018. We are also modifying comments on each of these issues as we Health Options Program (SHOP), the 10 percent threshold for prepare rulemaking on these topics. permitting them to operate these reasonableness review to a 15 percent Instituting strong program safeguards Exchanges more efficiently, and default threshold. to ensure that only individuals who are therefore benefitting States, issuers, Recognizing that Exchanges, eligible are enrolled in Exchange employers, and employees. These including the FFEs, face resource coverage, and that they are only

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receiving the amount of financial Section 2703 of the PHS Act, as added health and substance use disorder assistance for which they are eligible, is by the PPACA, and sections 2712 and services, including behavioral health essential to ensuring that the Exchanges 2741 of the PHS Act, as added by the treatment; prescription drugs; operate as intended, and is also a key Health Insurance Portability and rehabilitative and habilitative services priority for the Administration. We have Accountability Act of 1996 (Pub. L. and devices; laboratory services; already taken action to strengthen 104–191) (HIPAA) prior to the preventive and wellness services and safeguards around Exchange eligibility, enactment of the PPACA, require health chronic disease management; and most recently through the insurance issuers that offer health pediatric services, including oral and implementation of pre-enrollment insurance coverage in the group or vision care. verification for special enrollment individual market to renew or continue Section 1301(a)(1)(B) of the PPACA periods; however, we continue to be in force such coverage at the option of directs all issuers of QHPs to cover the interested in exploring ways to further the plan sponsor or individual unless an EHB package described in section safeguard Federal tax dollars flowing exception applies. 1302(a) of the PPACA, including through Exchanges. Section 2718 of the PHS Act, as added coverage of the services described in by the PPACA, generally requires health II. Background section 1302(b) of the PPACA, to adhere insurance issuers to submit an annual to the cost-sharing limits described in A. Legislative and Regulatory Overview MLR report to HHS, and provide rebates section 1302(c) of the PPACA and to The Patient Protection and Affordable to enrollees if the issuers do not achieve meet the AV levels established in Care Act (Pub. L. 111–148) was enacted specified MLR thresholds. section 1302(d) of the PPACA. Section Section 2794 of the PHS Act, as added on March 23, 2010. The Health Care and 2707(a) of the PHS Act, which is by the PPACA, directs the Secretary of Education Reconciliation Act of 2010 effective for plan or policy years HHS (the Secretary), in conjunction (Pub. L. 111–152), which amended and beginning on or after January 1, 2014, with the States, to establish a process for revised several provisions of the Patient extends the coverage of the EHB the annual review of ‘‘unreasonable Protection and Affordable Care Act, was package to non-grandfathered increases in premiums for health enacted on March 30, 2010. In this final individual and small group health insurance coverage.’’ 2 The law also rule, we refer to the two statutes insurance coverage, irrespective of requires health insurance issuers to collectively as the ‘‘Patient Protection whether such coverage is offered submit to the Secretary and the and Affordable Care Act’’ or ‘‘PPACA.’’ through an Exchange. In addition, applicable State justifications for Subtitles A and C of title I of the section 2707(b) of the PHS Act directs unreasonable premium increases prior PPACA reorganized, amended, and non-grandfathered group health plans to to the implementation of the increases. added to the provisions of part A of title ensure that cost sharing under the plan Section 2794(b)(2) of the PHS Act XXVII of the Public Health Service Act does not exceed the limitations further specifies that beginning with (PHS Act) relating to group health plans described in sections 1302(c)(1) of the plan years starting in 2014, the and health insurance issuers in the PPACA. Secretary, in conjunction with the group and individual markets. Section 1302(d) of the PPACA Section 2701 of the PHS Act, as added States, will monitor premium increases of health insurance coverage offered describes the various levels of coverage by the PPACA, restricts the variation in based on actuarial value (AV). premium rates charged by a health through an Exchange and outside of an Exchange. Consistent with section 1302(d)(2)(A) of insurance issuer for non-grandfathered the PPACA, AV is calculated based on health insurance coverage in the Section 1252 of the PPACA provides that any standard or requirement the provision of EHB to a standard individual or small group market to population. Section 1302(d)(3) of the certain specified factors. These factors adopted by a State under title I of the PPACA, or any amendment made by PPACA directs the Secretary to develop are family size, rating area, age and guidelines that allow for de minimis tobacco use. title I of the PPACA, is to be applied uniformly to all health plans in each variation in AV calculations. Section 2701 of the PHS Act operates Section 1311(b)(1)(B) of the PPACA in coordination with section 1312(c) of insurance market to which the standard and requirement apply. directs that the Small Business Health the PPACA. Section 1312(c) of the Options Program assist qualified small PPACA generally requires a health Section 1302 of the PPACA provides employers in facilitating the enrollment insurance issuer to consider all for the establishment of an EHB package of their employees in QHPs offered in enrollees in all health plans (except for that includes coverage of EHB (as the small group market. Sections grandfathered health plans) offered by defined by the Secretary), cost-sharing 1312(f)(1) and (2) of the PPACA define such issuer to be members of a single limits, and actuarial value requirements. qualified individuals and qualified risk pool for each of its individual and The law directs that EHBs be equal in employers. Under section 1312(f)(2)(B) small group markets. States have the scope to the benefits provided under a of the PPACA, beginning in 2017, States option to merge the individual market typical employer plan, and that they have the option to allow issuers to offer and small group market risk pools under cover at least the following 10 general categories: Ambulatory patient services; QHPs in the large group market through section 1312(c)(3) of the PPACA. 3 Section 2702 of the PHS Act, as added emergency services; hospitalization; an Exchange. Section 1312(a)(2) of the by the PPACA, requires health maternity and newborn care; mental PPACA provides that in a SHOP, a insurance issuers that offer health qualified employer may select a level of Portability and Accountability Act of 1996 (HIPAA) coverage, and that employees may then, insurance coverage in the group or amended the PHS Act (formerly section 2711) to individual market in a State to offer in turn, choose SHOP plans within the generally require guaranteed availability of coverage level selected by the qualified employer. coverage to and accept every employer for employers in the small group market. and individual in the State that applies 2 The implementing regulations in part 154 limit for such coverage unless an exception the scope of the requirements under section 2794 3 If a State elects this option, the rating rules in 1 of the PHS Act to health insurance issuers offering section 2701 of the PHS Act and its implementing applies. health insurance coverage in the individual market regulations will apply to all coverage offered in or small group market. See Rate Increase Disclosure such State’s large group market (except for self- 1 Before enactment of the Patient Protection and and Review; Final Rule, 76 FR 29964, 29966 (May insured group health plans) pursuant to section Affordable Care Act, the Health Insurance 23, 2011). 2701(a)(5) of the PHS Act.

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Section 1311(c)(1)(B) of the PPACA beyond those received by the general Treasury, to designate other health requires the Secretary to establish public. benefits coverage as MEC. Under tax minimum criteria for provider network Section 1321(c)(2) of the PPACA reform legislation that was enacted on adequacy that a health plan must meet authorizes the Secretary to enforce the December 22, 2017, the individual to be certified as a QHP. Exchange standards using civil money shared responsibility payment is Section 1311(c)(5) of the PPACA penalties (CMPs) on the same basis as reduced to $0, effective for months requires the Secretary to continue to detailed in section 2723(b) of the PHS beginning after December 31, 2018.5 operate, maintain, and update the Act. Section 2723(b) of the PHS Act The Protecting Affordable Coverage internet portal developed under section authorizes the Secretary to impose for Employees Act (Pub. L. 114–60) 1103 of the PPACA to provide CMPs as a means of enforcing the amended section 1304(b) of the PPACA information to consumers and small individual and group market reforms and section 2791(e) of the PHS Act to businesses on affordable health contained in Part A of title XXVII of the amend the definition of small employer insurance coverage options. PHS Act when a State fails to in these statutes to mean, in connection Sections 1311(d)(4)(K) and 1311(i) of substantially enforce these provisions. with a group health plan with respect to the PPACA direct all Exchanges to Section 1321(d) of the PPACA a calendar year and a plan year, an establish a Navigator program. provides that nothing in title I of the employer who employed an average of Section 1311(c)(6)(C) of the PPACA PPACA should be construed to preempt at least 1 but not more than 50 establishes special enrollment periods any State law that does not prevent the employees on business days during the and section 1311(c)(6)(D) of the PPACA application of title I of the PPACA. preceding calendar year and who establishes the monthly enrollment Section 1311(k) of the PPACA specifies employs at least 1 employee on the first period for Indians, as defined by section that Exchanges may not establish rules day of the plan year. It also amended 4 of the Indian Health Care that conflict with or prevent the these statutes to make conforming Improvement Act. application of regulations issued by the changes to the definition of large Section 1312(e) of the PPACA directs Secretary. employer, and to provide that a State the Secretary to establish procedures Section 1343 of the PPACA may treat as a small employer, with under which a State may permit agents establishes a permanent risk adjustment respect to a calendar year and a plan and brokers to enroll qualified program to provide payments to health year, an employer who employed an individuals and qualified employers in insurance issuers that attract higher-risk average of at least 1 but not more than QHPs through an Exchange and to assist populations, such as those with chronic 100 employees on business days during individuals in applying for financial conditions, funded by payments from the preceding calendar year and who assistance for QHPs sold through an those that attract lower-risk populations; employs at least 1 employee on the first Exchange. thereby, reducing incentives for issuers day of the plan year. Section 1321(a) of the PPACA to avoid higher-risk enrollees. provides broad authority for the Section 1402 of the PPACA provides 1. Premium Stabilization Programs 6 Secretary to establish standards and for, among other things, reductions in In the July 15, 2011 Federal Register regulations to implement the statutory cost sharing for EHB for qualified low- (76 FR 41929), we published a proposed requirements related to Exchanges, and moderate-income enrollees in silver rule outlining the framework for the level health plans offered through the QHPs and other components of title I of premium stabilization programs. We individual market Exchanges. This the PPACA. Section 1321(a)(1) of the implemented the premium stabilization section also provides for reductions in PPACA directs the Secretary to issue programs in a final rule, published in cost sharing for Indians enrolled in regulations that set standards for the March 23, 2012 Federal Register (77 meeting the requirements of title I of the QHPs at any metal level. Section 5000A of the Code, as added FR 17219) (Premium Stabilization Rule). PPACA with respect to, among other In the December 7, 2012 Federal things, the establishment and operation by section 1501(b) of the PPACA, requires all applicable individuals to Register (77 FR 73117), we published a of Exchanges. proposed rule outlining the benefit and Sections 1313 and 1321 of the PPACA maintain minimum essential coverage payment parameters for the 2014 benefit provide the Secretary with the authority (MEC) for each month or make an year to expand the provisions related to to oversee the financial integrity of State individual shared responsibility the premium stabilization programs and Exchanges, their compliance with HHS payment. Section 5000A(f) of the Code set forth payment parameters in those standards, and the efficient and non- defines MEC as any of the following: (1) programs (proposed 2014 Payment discriminatory administration of State Coverage under a specified government Notice). We published the 2014 Exchange activities. Section 1321 of the sponsored program; (2) coverage under Payment Notice final rule in the March PPACA provides for State flexibility in an eligible employer-sponsored plan; (3) 11, 2013 Federal Register (78 FR the operation and enforcement of coverage under a health plan offered in 15409). Exchanges and related requirements. the individual market within a State; In the December 2, 2013 Federal When operating an FFE under section and (4) coverage under a grandfathered Register (78 FR 72321), we published a 1321(c)(1) of the PPACA, HHS has the health plan. In addition, the HEALTHY proposed rule outlining the benefit and authority under sections 1321(c)(1) and KIDS Act amended section payment parameters for the 2015 benefit 1311(d)(5)(A) of the PPACA to collect 5000A(f)(1)(A)(iii) of the Code to year to expand the provisions related to and spend user fees. In addition, 31 include in the definition of MEC CHIP the premium stabilization programs, U.S.C. 9701 permits a Federal agency to look-alike plans, which are CHIP buy-in setting forth certain oversight provisions establish a charge for a service provided programs that provide benefits that are and establishing the payment by the agency. Office of Management at least identical to the benefits parameters in those programs (proposed and Budget (OMB) Circular A–25 provided by the title XXI CHIP 2015 Payment Notice). We published Revised establishes Federal policy program.4 Section 5000A(f)(1)(E) of the regarding user fees and specifies that a Code authorizes the Secretary of HHS, 5 Public Law 115–97, 131 Stat. 2054. user charge will be assessed against in coordination with the Secretary of the 6 By ‘‘premium stabilization programs,’’ we are each identifiable recipient for special referring to the risk adjustment, risk corridors and benefits derived from Federal activities 4 Public Law 115–120, 101 (2018). reinsurance programs established by the PPACA.

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the 2015 Payment Notice final rule in implement components of the published a bulletin that outlined its the March 11, 2014 Federal Register (79 Exchanges, and a rule in the August 17, intended regulatory approach to FR 13743). 2011 Federal Register (76 FR 51201) calculations of AV on February 24, In the November 26, 2014 Federal regarding Exchange functions in the 2012.8 A proposed rule relating to EHBs Register (79 FR 70673), we published a individual market and SHOP, eligibility and AVs was published in the proposed rule outlining the benefit and determinations, and Exchange standards November 26, 2012 Federal Register (77 payment parameters for the 2016 benefit for employers. A final rule FR 70643). We established requirements year to expand the provisions related to implementing components of the relating to EHBs and AVs in the the premium stabilization programs, Exchanges and setting forth standards Standards Related to Essential Health setting forth certain oversight provisions for eligibility for Exchanges was Benefits, Actuarial Value, and and establishing the payment published in the March 27, 2012 Accreditation Final Rule, which was parameters in those programs (proposed Federal Register (77 FR 18309) published in the February 25, 2013 2016 Payment Notice). We published (Exchange Establishment Rule). Federal Register (78 FR 12833) (EHB the 2016 Payment Notice final rule in We established additional standards Rule). In the April 18, 2017 Market the February 27, 2015 Federal Register for SHOP in the 2014 Payment Notice Stabilization final rule (82 FR 18346), (80 FR 10749). and in the Amendments to the HHS we expanded the de minimis range In the December 2, 2015 Federal Notice of Benefit and Payment applicable to plan metal levels. Register (80 FR 75487), we published a Parameters for 2014 interim final rule, 5. Minimum Essential Coverage proposed rule outlining the benefit and published in the March 11, 2013 payment parameters for the 2017 benefit Federal Register (78 FR 15541). The In the February 1, 2013 Federal year to expand the provisions related to provisions established in the interim Register (78 FR 7348), we published a the premium stabilization programs, final rule were finalized in the second proposed rule that designates other setting forth certain oversight provisions Program Integrity Rule. We also set forth health benefits coverage as MEC and and establishing the payment standards related to Exchange user fees outlines substantive and procedural parameters in those programs (proposed in the 2014 Payment Notice. We requirements that other types of 2017 Payment Notice). We published established an adjustment to the FFE coverage must fulfill in order to be the 2017 Payment Notice final rule in user fee in the Coverage of Certain recognized as MEC. The provisions were the March 8, 2016 Federal Register (81 Preventive Services Under the finalized in the July 1, 2013 Federal FR 12203). Affordable Care Act final rule, Register (78 FR 39494). In the November 26, 2014 Federal In the September 6, 2016 Federal published in the July 2, 2013 Federal Register (79 FR 70674), we published a Register (81 FR 61455), we published a Register (78 FR 39869) (Preventive proposed rule seeking comments on proposed rule outlining the benefit and Services Rule). payment parameters for the 2018 benefit whether State high risk pools should be In a final rule published in the July permanently designated as MEC or year, and to further promote stable 17, 2013 Federal Register (78 FR premiums in the individual and small whether the designation should be time- 42823), we established standards for limited. In the February 27, 2015 group markets. We proposed updates to Navigators and non-Navigator assistance the risk adjustment methodology, new Federal Register (80 FR 10750), we personnel in FFEs and for non- designated State high risk pools policies around the use of external data Navigator assistance personnel funded for recalibration of our risk adjustment established on or before November 26, through an Exchange establishment 2014 as MEC. models, and amendments to the risk grant. This final rule also established a adjustment data validation process certified application counselor program 6. Market Rules (proposed 2018 Payment Notice). We for Exchanges and set standards for that published the 2018 Payment Notice A proposed rule relating to the 2014 program. health insurance market rules was final rule in the December 22, 2016 In an interim final rule, published in Federal Register (81 FR 94058). published in the November 26, 2012 the May 11, 2016 Federal Register (81 Federal Register (77 FR 70584). A final 2. Program Integrity FR 29146), we made amendments to the rule implementing the health insurance In the June 19, 2013 Federal Register parameters of certain special enrollment market rules was published in the (78 FR 37031), we published a proposed periods (2016 Interim Final Rule). We February 27, 2013 Federal Register (78 rule that proposed certain program finalized these in the 2018 Payment FR 13406) (2014 Market Rules). integrity standards related to Exchanges Notice final rule in the December 22, A proposed rule relating to Exchanges and the premium stabilization programs 2016 Federal Register (81 FR 94058). In and Insurance Market Standards for (proposed Program Integrity Rule). The the April 18, 2017 Market Stabilization 2015 and Beyond was published in the provisions of that proposed rule were final rule Federal Register (82 FR March 21, 2014 Federal Register (79 FR finalized in two rules, the ‘‘first Program 18346), we amended standards relating 15808) (2015 Market Standards Integrity Rule’’ published in the August to special enrollment periods and QHP Proposed Rule). A final rule 30, 2013 Federal Register (78 FR 54069) certification. implementing the Exchange and Insurance Market Standards for 2015 and the ‘‘second Program Integrity 4. Essential Health Benefits and and Beyond was published in the May Rule’’ published in the October 30, 2013 Actuarial Value 27, 2014 Federal Register (79 FR 30240) Federal Register (78 FR 65045). On December 16, 2011, HHS released (2015 Market Standards Rule). The 2018 3. Exchanges a bulletin 7 (the EHB Bulletin) that Payment Notice final rule in the We published a request for comment outlined an intended regulatory December 22, 2016 Federal Register (81 relating to Exchanges in the August 3, approach for defining EHB, including a FR 94058) provided additional guidance 2010 Federal Register (75 FR 45584). benchmark-based framework. HHS also on guaranteed availability and We issued initial guidance to States on 7 Exchanges on November 18, 2010. We ‘‘Essential Health Benefits Bulletin.’’ December 8 ‘‘Actuarial Value and Cost-Sharing Reductions 16, 2011. Available at https://www.cms.gov/CCIIO/ Bulletin.’’ February 24, 2012. Available at https:// proposed a rule in the July 15, 2011 Resources/Files/Downloads/essential_health_ www.cms.gov/CCIIO/Resources/Files/Downloads/ Federal Register (76 FR 41865) to benefits_bulletin.pdf. Av-csr-bulletin.pdf.

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guaranteed renewability. In the April regular contact with States through the Programs to set later submission 18, 2017 Market Stabilization final rule Exchange Establishment grant and deadlines for rate filings from issuers (82 FR 18346), we released further Exchange Blueprint approval processes, that offer non-QHPs only. In addition, guidance related to guaranteed and meetings with Tribal leaders and we are finalizing the change to the availability. representatives, health insurance notification period for States with issuers, trade groups, consumer Effective Rate Review Programs to 7. Rate Review advocates, employers, and other provide advance notice to HHS prior to A proposed rule to establish the rate interested parties. We considered all posting rate increases (from 30 days to review program was published in the public input we received as we 5 business days). December 23, 2010 Federal Register (75 developed the policies in this final rule. The final regulations in part 155 FR 81003). A final rule with comment HHS also received several thousand include modifications to the functions period implementing the rate review unique comments in response to a of an Exchange, and a new approach to program was published in the May 23, request for information, entitled operational readiness reviews for direct 2011 Federal Register (76 FR 29963) ‘‘Reducing Regulatory Burdens Imposed enrollment partners which will allow (Rate Review Rule). The provisions of by the Patient Protection and Affordable agents, brokers, and issuers to select the Rate Review Rule were amended in Care Act and Improving Healthcare their own third-party entities for final rules published in the September Choices to Empower Patients’’, conducting those reviews. We are 6, 2011 Federal Register (76 FR 54969), published in the June 12, 2017 Federal finalizing modifications to the rules the February 27, 2013 Federal Register Register (82 FR 26885) (Request for around verification of eligibility. We are (78 FR 13405), the May 27, 2014 Federal Information). We anticipate continuing also finalizing increased flexibility in Register (79 FR 30239), the February 27, to address comments in future the Navigator program by removing the 2015 Federal Register (80 FR 10749), rulemaking and guidance. requirement that each Exchange must the March 8, 2016 Federal Register (81 have at least two Navigator entities, one C. Structure of Final Rule FR 12203) and the December 22, 2016 of which must be a community and Federal Register (81 FR 94058). The regulations outlined in this final consumer focused non-profit, and by rule will be codified in 45 CFR parts 8. Medical Loss Ratio removing the standard requiring 147, 153, 154, 155, 156, 157, and 158. physical presence of the Navigator We published a request for comment The final regulations in part 147 entity in the Exchange service area. We on section 2718 of the PHS Act in the amend the rules regarding fair health are modifying the parameters around April 14, 2010 Federal Register (75 FR insurance premiums and guaranteed certain special enrollment periods. We 19297), and published an interim final availability to reflect final changes are modifying the effective date options rule with a 60-day comment period related to the SHOPs and special for enrollee-initiated terminations, at relating to the MLR program on enrollment periods. the option of the Exchange, and December 1, 2010 (75 FR 74863). A final In connection with part 153, we are amending the affordability exemption so rule with a 30-day comment period was recalibrating the risk adjustment models that it may be based on the lowest cost published in the December 7, 2011 consistent with the methodology Exchange plan if there is no bronze level Federal Register (76 FR 76573). An finalized for the 2018 benefit year with plan sold through the Exchange in that interim final rule with a 60-day slight modifications to the drug classes rating area. comment period was published in the included in the 2019 benefit year adult The final regulations in part 156 December 7, 2011 Federal Register (76 models and the incorporation of include changes to EHB and the QHP ® FR 76595). A final rule was published blended MarketScan and the most certification process. The final in the Federal Register on May 16, 2012 recent enrollee-level External Data regulations in part 156 set forth (77 FR 28790). The medical loss ratio Gathering Environment (EDGE) data. parameters related to cost sharing, program requirements were amended in This final rule addresses the high-cost including the premium adjustment final rules published in the March 11, risk pooling adjustment, where we are percentage, the maximum annual 2014 Federal Register (79 FR 13743), finalizing the same parameters that limitation on cost sharing, and the the May 27, 2014 Federal Register (79 applied to the 2018 benefit year for the reductions in the maximum annual FR 30339), the February 27, 2015 2019 benefit year risk adjustment. The limitation for cost-sharing plan Federal Register (80 FR 10749), the finalized provisions related to part 153 variations for 2019. The regulations at March 8, 2016 Federal Register (81 FR include the risk adjustment user fee and part 156 also include finalized FFE and 12203), and the December 22, 2016 modifications to risk adjustment data SBE–FP user fee rates for the 2019 Federal Register (81 FR 94183). validation. We also finalize a policy to benefit year for all issuers participating provide States flexibility to request on the FFEs or SBE–FPs. The B. Stakeholder Consultation and Input reductions in risk adjustment transfers regulations at part 156 also include HHS has consulted with stakeholders in the small group market starting for finalized policies related to actuarial on policies related to the operation of the 2020 benefit year and beyond. value for stand-alone dental plans Exchanges, including the SHOP, and the The final regulations in part 154 (SADPs). premium stabilization programs. We finalize certain modifications to reduce The final amendments to the have held a number of listening sessions regulatory burden and enhance State regulations in parts 155, 156, and 157 with consumers, providers, employers, flexibility for the rate review program. include finalized proposals that would health plans, and the actuarial We are finalizing an exemption for provide SHOPs with additional community to gather public input. We student health insurance coverage from operational flexibility, and would have solicited input from State Federal rate review requirements. We modify the requirements for issuers, representatives on numerous topics, are finalizing a proposal to raise the employers, and employees interacting particularly EHB, QHP certification and default threshold for review of with SHOPs. Exchange establishment. We consulted reasonableness in the rate review The final amendments to the with stakeholders through regular process from 10 percent to 15 percent. regulations in part 158 include revisions meetings with the National Association We also are finalizing a proposal to related to reporting quality of Insurance Commissioners (NAIC), allow States with Effective Rate Review improvement activity expenses as part

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of the formula for calculating MLR, and also providing industry and other acknowledged the consumer benefits of revisions related to State requests for stakeholders with more time to lowering drug costs and having more adjustment to the individual market implement the final rule. transparent drug pricing; however, MLR standard. Comment: We received some commenters cautioned that any changes comments generally supportive of State be done in a thoughtful manner, that III. Provisions of the Proposed Rule and flexibility, stating that by removing considers value in addition to cost, with Analysis of and Responses to Public existing regulatory barriers, issuers will Comments input from all stakeholders. be able to offer a more diverse selection Response: We appreciate the ideas for In the November 2, 2017 Federal of coverage options that meet both the future rulemaking and will consider Register (82 FR 51052), we published financial and health coverage needs of these suggestions. the ‘‘Patient Protection and Affordable consumers while meeting various State Care Act; HHS Notice of Benefit and needs. A. Part 147—Health Insurance Reform Payment Parameters for 2019’’ proposed Response: We agree that State Requirements for the Group and rule (proposed 2019 Payment Notice or flexibility with respect to oversight of Individual Health Insurance Markets proposed rule). We received 416 State insurance markets is an important 1. Fair Health Insurance Premiums comments, including 99 comments that goal, and recognize the traditional role (§ 147.102) were substantially similar to one of four States have as the primary regulators of different letters, each regarding the their insurance markets. States are best As discussed elsewhere in this final proposals on EHBs, one addressing positioned to address the specific needs rule, we are finalizing substantial EHBs and the Navigator program, and of their consumers, and may be better changes to the requirements applicable one addressing proposals related to able than the Federal government to to SHOPs to provide those programs EHBs, Navigators, SHOPs and network develop policies that are tailored to with the flexibility to operate in a leaner adequacy. Comments were received allow issuers in their State to develop fashion, a flexibility that we intend to from State entities, such as departments plans that address both the needs and utilize in the Federally-facilitated Small of insurance and State Exchanges; cost concerns of beneficiaries in their Business Health Options Program (FF– health insurance issuers; providers, both State. SHOP). As part of these changes and, as individuals and provider groups; Comment: We received numerous discussed in the preamble to §§ 156.285 consumer groups; industry groups; comments cautioning us about making and 156.286, we proposed that, effective national interest groups; and other changes that would weaken the PPACA. on the effective date of this rule, the stakeholders. The comments ranged Some commenters expressed concern requirement in § 156.285(a)(4)(ii) from general support of or opposition to that the proposed changes would regarding premium rating standards in the proposed provisions to specific remove some of the protections afforded the FF–SHOPs would not apply for plan questions or comments regarding by the PPACA, such as the certainty of years beginning on or after January 1, proposed changes. We received a EHBs. 2018. Therefore, we proposed to delete number of comments and suggestions Response: Our top priority at HHS is from § 147.102(c)(3)(iii)(D) a reference to that were outside the scope of the putting consumers first. While we have § 156.285(a)(4), and to replace the proposed rule that will not be addressed made great strides forward, there is still reference to FF–SHOPs with a reference in this final rule. work to be done, including ensuring to SHOPs generally, to reflect that, In this final rule, we provide a that coverage is affordable to all under the proposed approach for summary of each proposed provision, a consumers. We have already taken SHOPs, some SHOPs may want to summary of those public comments important steps to streamline our prohibit issuers from offering average received that directly related to the regulations and our operations with the enrollee premiums. proposals, our responses to them, and a goal of reducing unnecessary burden, We did not receive comments on this description of the provisions we are increasing efficiencies and improving proposal, and are finalizing the change finalizing. the consumer experience. Yet, we have as proposed, with one minor Comment: We received multiple recently seen how regulations intended typographical correction. comments criticizing the short comment to protect consumers can, instead, We also sought comment on whether period, stating that the comment period undermine consumers’ access to issuers offering coverage through SHOPs made it difficult for stakeholders to affordable health coverage. In this final should always be required to offer conduct an in-depth analysis of the rule, we finalize policies that are average enrollee premiums, or should be proposed rule. Commenters suggested intended to help control costs of required to do so only if required under that HHS adopt a comment period of at coverage in order to make coverage applicable State law. least 30 days from rule publication, and more affordable for consumers, Comment: Comments were mixed to fully comply with notice-and- particularly unsubsidized consumers. regarding whether issuers offering comment requirements under the We will continue to find innovative coverage through SHOPs should always Administrative Procedure Act. ways to reduce costs and burdens while be required to offer average enrollee Response: The timeline for meeting the health needs of all premiums. One commenter stated that publication of this final rule Americans. We are continuing to issuers offering coverage through SHOPs accommodates issuer filing deadlines address feedback we receive from should always be required to offer for the 2019 benefit year. A longer stakeholders and the public, and in turn average enrollee premiums, while others comment period would have delayed we are making changes that will better stated that issuers should be required to the publication of this final rule, and serve consumers and allow States to do so only if required by applicable created significant challenges for States, address the unique health needs of their State law. One of these commenters Exchanges, issuers, and other entities in populations. further recommended that average meeting deadlines related to Comment: Commenters responded to premium rating should be permitted implementing these rules. We will our request for comment on ideas for only when a SHOP does not allow continue to try to expand the comment future rulemaking about ways to help employees to choose plans among period for the annual HHS notice of reduce drug costs and promote drug multiple issuers. The commenter stated benefit and payment parameters while price transparency. All commenters that average enrollee premiums based

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on employees selecting a particular plan January 1, 2018, QHPs offered in the reference to clarify that it is permissible could result in illogical rates, such as a SHOP may restrict the availability of for issuers to apply an effective date of richer plan having lower rates than a coverage, with respect to a group health coverage that is before or on the leaner plan because only younger plan that cannot comply with group specified dates. We are also modifying employees selected the richer plan. participation rules, to an annual the proposed language so that the Another commenter stated that all enrollment period of November 15 effective date of coverage is tied to the issuers, regardless of whether they are through December 15 of each calendar date a group enrollment is received, offering coverage on or off SHOP, year. Because we are finalizing new rather than to the date a plan selection should be allowed to offer average § 156.286(e) as proposed, we are also is received. enrollee premiums. finalizing the proposal to reference new Comment: All commenters supported Response: For purposes of § 156.286(e) in § 147.104(b)(1)(i)(B). in principle the proposal to eliminate, consistency, we believe that issuers Comment: One commenter supported from § 147.104(b)(1)(i)(C), the cross offering coverage through a SHOP the proposal to add to reference to the effective dates of should be permitted to offer average § 147.104(b)(1)(i)(B) a reference to coverage in § 155.725, and in its place enrollee premiums to the same extent § 156.286(e). One commenter opposed explicitly specify in § 147.104(b)(1)(i)(C) that issuers may do so off SHOP under permitting QHPs to restrict coverage those effective dates for coverage in the existing State rules. Also, given the availability when a group health plan small group market, and for the large decrease in issuer participation in the cannot comply with group participation group market if such coverage is offered FF–SHOPs, some SHOP employers only rules, while another commenter stated through a SHOP. However, several have one issuer offering FF–SHOP plans that an employer that fails to comply commenters noted that our proposal did in their area and will not be able to offer with such rules should not be afforded not import the provisions in § 155.725, their employers a choice of plans across guaranteed availability of coverage, describing the coverage effective dates, issuers. In addition, historically, a either generally or during an annual verbatim into § 147.104(b)(1)(i)(C). They majority of employers have not offered open enrollment period, either on or off- observed that the proposed language in employee choice across different SHOP. § 147.104(b)(1)(i)(C) tied the coverage issuers, thus mitigating the risk of Response: As indicated in the section effective date to the date a plan variance in average premium rates of the preamble discussing the SHOP selection was received, rather than to across plans. Therefore, we do not rule, we are finalizing, as proposed, the the date a group enrollment was believe Federal guidance or regulation is proposal to add new § 156.286(e), which received, and that tying the coverage currently warranted in this area. Thus, would apply, to plan years starting on date to the date a group enrollment was issuers offering coverage through a or after January 1, 2018, the existing received (as in the effective-date-of- SHOP may offer average enrollee regulatory provision that allows QHPs coverage language currently set forth in premiums to the extent required or offered in the SHOP to restrict the § 155.725) would be more appropriate. permitted by the applicable State, and availability of coverage with respect to Commenters also stated that the will not be required under Federal law a group health plan that cannot comply language we proposed to add in to do so, unless required by the State. with group participation rules, to an § 147.104(b)(1)(i)(C), unlike the language annual enrollment period of November in current regulations in § 155.725, 2. Guaranteed Availability of Coverage 15 through December 15 of each would prohibit issuers from applying a (§ 147.104) calendar year. Thus, we are also coverage effective date that falls before i. SHOP finalizing the proposal to reference new the first day of the following month, or § 156.286(e) in § 147.104(b)(1)(i)(B). before the first day of the second As discussed elsewhere in this final We also proposed, and are finalizing, following month, as applicable, after the rule, we proposed and are finalizing the removal of the small group coverage date a group enrollment is received. substantial changes to the requirements effective dates that are found in the Response: As commenters pointed applicable to SHOPs to provide them SHOP regulations at § 155.725 with out, in the language we proposed for with the flexibility to operate in a leaner respect to plan years beginning on or § 147.104(b)(1)(i)(C), we tied the fashion, a flexibility that we will utilize after January 1, 2018, effective on the coverage effective date to the date a plan in the FF–SHOPs. Among those effective date of this rule. However, selection, rather than a group changes, effective on the effective date there are currently requirements in enrollment, was received. Given that the of this rule, the requirements in § 147.104(b)(1)(i)(C) that, by cross- proposed language we added appears in § 156.285 will apply for plan years referencing § 155.725, apply those same a section of the rules (§ 147.104) that starting before January 1, 2018. New requirements marketwide, and we did applies marketwide, and not just in § 156.286 specifies those requirements not propose to remove that marketwide SHOPs, we agree with the commenters contained in § 156.285 that, effective on requirement. We proposed changes to that tying the coverage date to a group the effective date of this rule, will § 147.104 to reflect the SHOP changes. enrollment, which is a broader term continue to apply for plan years starting Specifically, we proposed to eliminate, than a plan selection (the latter is a on or after January 1, 2018. Among from § 147.104(b)(1)(i)(C), the cross- SHOP-specific term), would be more those requirements is the requirement in reference to § 155.725. We proposed in appropriate. We also agree with the § 156.285(e) which permits a QHP place of the cross-reference to explicitly commenters that the existing language offered in the SHOP to apply group specify in § 147.104(b)(1)(i)(C) those in § 155.725, which requires issuers to participation rules under certain same coverage effective dates for ensure a coverage effective date of, circumstances. This provision will be coverage in the small group market, and rather than on, the dates specified in the listed in new § 156.286(e). The for the large group market if such existing language, permits issuers to marketwide regulations at coverage is offered through a SHOP, that apply an enrollment date that falls § 147.104(b)(1)(i)(B) currently reference would be eliminated from the SHOP before, rather than only on, the first day § 156.285(e), and we proposed to add a regulations under our proposal for of the first month or the first day of the reference to § 156.286(e) to clarify that, § 155.725. We are finalizing this second month (as applicable) following effective on the effective date of this proposal, but are modifying the the date a group enrollment is received, rule, for plan years that start on or after language that will replace the cross- and that issuers should continue to have

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the flexibility to apply an enrollment would also apply.9 However, in this placement in foster care, or through a date that falls before those dates. instance the reference to ‘‘QHP’’ should child support order or other court order. Therefore, in light of those comments, not be deemed to refer to a plan for We sought comment on whether this we are finalizing language in purposes of applying § 147.104(b)(2). special enrollment period should afford § 147.104(b)(1)(i)(C). Therefore, we proposed to amend an individual’s existing dependents an § 147.104(b)(2)(ii) to state that a independent opportunity to enroll, off- ii. Special Enrollment Periods reference in § 155.420 (other than in Exchange, in new coverage or make Section 147.104(b)(2)(i) extends § 155.420(a)(5)) to a ‘‘QHP’’ is deemed to changes to their existing coverage. As several of the special enrollment periods refer to a plan, a reference to ‘‘the applied to on-Exchange coverage, when that apply to issuers on the Exchange, Exchange’’ is deemed to refer to the a qualified individual gains or becomes to all issuers in the individual market. applicable State authority, and a a new dependent under the Although § 147.104(b)(2)(i) is intended reference to a ‘‘qualified individual’’ is circumstances described in to specify which special enrollment deemed to refer to an individual in the § 155.420(d)(2)(i), the qualified periods offered through the Exchange individual market. We are finalizing this individual is afforded a special must also be offered by health insurance change as proposed. enrollment period to enroll in or change issuers with respect to coverage offered Comment: All commenters supported Exchange coverage with his or her outside of an Exchange, the paragraph this proposal, while some commenters dependents, including his or her newly- as currently written could be read to stated more generally that special gained dependent, in accordance with apply the exceptions to any coverage enrollment periods should be the same, any applicable metal level restrictions offered by a health insurance issuer in regardless of whether an individual is outlined in § 155.420(a)(4)(i). The new the individual market. We recognize the seeking coverage on or off-Exchange. dependent is also afforded an potential for confusion, as coverage One commenter suggested that we independent special enrollment period offered through an Exchange is offered publish a list of bare counties so that the under which he or she can enroll in or by a health insurance issuer in the exemption to the prior-coverage change Exchange coverage as a individual market, but this coverage is requirement can be properly applied subscriber, as opposed to as a subject to the special enrollment rule at both on and off-Exchange. dependent of the qualified individual. § 155.420(d), which is intended to Response: We are finalizing the Under the HIPAA special enrollment require special enrollment periods for proposal, consistent with the way in provisions that continue to apply to qualifying events including those listed which the amendment to § 155.420(a)(5) group health plans and health insurance in the exceptions in § 147.104(b)(2)(i). is being finalized, and if there are ever issuers in connection with group health Therefore, we proposed to amend that any service areas in which no qualified coverage, there are similar special phrase in § 147.104(b)(2)(i) to clarify health plans are offered through the enrollment periods when a child that the exceptions in the paragraph Exchange, we will consider publishing becomes a dependent of the employee only apply with respect to coverage a list of them, as the commenter through marriage, birth, adoption, or offered outside of the Exchange in the suggested. For a more detailed response placement for adoption.10 We sought individual market. We received no to comments regarding the amendment comment on whether, in the off- comments on this proposal, and are to § 155.420(a)(5), see the preamble to Exchange individual market, the special finalizing it as proposed. that section. enrollment periods for when an With respect to the subset of special Among the special enrollment periods individual gains a dependent or enrollment periods in § 155.420 that in § 155.420 that apply off-Exchange are becomes a new dependent under the apply off-Exchange, current regulations those specified in § 155.420(d)(2)(i), circumstances described in at § 147.104(b)(2)(ii) state that, in under which a qualified individual § 147.104(b)(2), which cross-references applying § 147.104(b)(2), a reference in gains a dependent or becomes a new § 155.420(d)(2)(i), should continue to § 155.420 to a ‘‘QHP’’ is deemed to refer dependent through marriage, birth, operate in the same manner as they do to a plan, a reference to ‘‘the Exchange’’ adoption, placement for adoption, or on-Exchange, whether they should is deemed to refer to the applicable operate in a manner consistent with the State authority, and a reference to a 9 As stated in the preamble in the proposed rule HIPAA group market regulations, or ‘‘qualified individual’’ is deemed to to § 155.420, the exception to the requirement to whether we should adopt some other refer to an individual in the individual have previous coverage is intended to relieve approach. market. As discussed in the preamble to individuals of that requirement when there was no affordable coverage (that is, coverage that could be With respect to off-Exchange § 155.420, we are finalizing a change to purchased through an Exchange to which APTC coverage, we are maintaining current § 155.420(a)(5) to exempt qualified might apply) available in their previous service policy under which an individual who individuals from the prior coverage area. We believe affordability is key to this qualifies for a special enrollment period requirement that applies to certain exception, and therefore, that the scope of the exception should apply equally, regardless of for gaining a dependent through special enrollment periods if they lived whether the individual is seeking to purchase marriage, birth, adoption, placement for in a service area where no qualified coverage inside or outside an Exchange during the adoption, or placement in foster care, or health plan was available through the special enrollment periods for which this exception through a child support order or other Exchange for 1 or more days during the applies; that is, the exception should apply if there court order under § 147.104(b)(2) may was no such affordable coverage available in the 60 days preceding the qualifying event individual’s previous service area (regardless of enroll in or change coverage along with or during their most recent preceding whether or not any coverage was being actively his or her dependents, including the enrollment period, as specified in marketed in that service area outside the Exchange). newly-gained dependent(s) and any §§ 155.410 and 155.420. Section Also, when an individual sought to purchase existing dependents. The new coverage outside an Exchange during such a special 155.420(a)(5) applies to qualifying enrollment period, we believe it might be dependent is also afforded an individuals seeking off-Exchange unreasonably difficult for an issuer to determine if independent special enrollment period coverage through an applicable special at least one issuer was actively marketing coverage under which he or she can enroll in or enrollment period, so we proposed that in the individual’s previous service area outside the change coverage as a subscriber, as Exchange, as opposed to determining if at least one this exception for individuals living in issuer was making coverage available in that service opposed to as a dependent of the a service area where there were no area specifically through an Exchange. We solicited QHPs offered through an Exchange comments on this approach. 10 See § 146.117(b).

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individual. This off-Exchange special reinsurance payments in the 2018 fiscal these age groups. In each of the adult enrollment period does not otherwise year, as the second contribution and child models, the relative risk provide to existing dependents an collection deadline for the 2016 benefit assigned to an individual’s age, sex, and independent opportunity to enroll in year was November 15, 2017. Therefore, diagnoses are added together to produce new coverage or make changes to their the reinsurance program will be an individual risk score. Additionally, existing coverage. sequestered at a rate of 6.6 percent for in the adult models, we added Comment: Some commenters stated payments made from fiscal year 2018 enrollment duration factors beginning that existing dependents should be resources (that is, funds collected for the 2017 benefit year, and entitled to enroll with other family during the 2018 fiscal year). The risk prescription drug utilization factors members who have qualified for the adjustment program will also be (RXCs) beginning for the 2018 benefit special enrollment period when a sequestered at a rate of 6.6 percent for year, in the calculation of enrollees’ risk qualified individual in their household payments made from fiscal year 2018 scores. Infant risk scores are determined gains a dependent or becomes a new resources (that is, funds collected by inclusion in one of 25 mutually dependent through marriage, birth, during the 2018 fiscal year). exclusive groups, based on the infant’s adoption, placement for adoption, or HHS, in coordination with the OMB, maturity and the severity of diagnoses. placement in foster care, or through a has determined that, under section If applicable, the risk score for adults, child support order or other court order, 256(k)(6) of the Balanced Budget and children or infants is multiplied by a while others believed they should not, Emergency Deficit Control Act of 1985, cost-sharing reductions adjustment. stating that allowing this practice would as amended, and the underlying The enrollment-weighted average risk contribute to adverse selection. Some authority for the reinsurance and risk score of all enrollees in a particular risk commenters stated that special adjustment programs, the funds that are adjustment covered plan (also referred enrollment periods should apply sequestered in fiscal year 2018 from the to as the plan liability risk score) within uniformly on-Exchange and off- reinsurance and risk adjustment a geographic rating area is one of the Exchange. programs will become available for inputs into the risk adjustment payment Response: As stated previously, we payment to issuers in fiscal year 2019 transfer formula, which determines the are continuing to apply the parameters without further Congressional action. If payment or charge that an issuer will of the special enrollment period for Congress does not enact deficit receive or be required to pay for that those who have gained or become a new reduction provisions that replace the plan. Thus, the HHS risk adjustment dependent through marriage, birth, Joint Committee reductions, these model predicts average group costs to adoption, foster care placement, or a programs would be sequestered in account for risk across plans, which child support or other court order off- future fiscal years, and any sequestered accords with the Actuarial Standards Exchange in the same manner as funding would become available in the Board’s Actuarial Standards of Practice applied on-Exchange. We believe the fiscal year following that in which it for risk classification. advantages and simplicity of uniformity was sequestered. b. Final Updates to the Risk Adjustment between on-Exchange and off-Exchange 2. Provisions and Parameters for the Model (§ 153.320) coverage in this instance outweigh the Risk Adjustment Program concern about adverse selection. For the 2019 benefit year, we In subparts D and G of part 153, we proposed to recalibrate the risk iii. Technical Changes established standards for the adjustment models using the We proposed to remove paragraph administration of the risk adjustment methodology finalized for the 2018 § 147.104(b)(1)(iii), along with the cross- program. The risk adjustment program benefit year, with small modifications to reference to it in § 147.104(b)(1)(ii), as is a permanent program created by the drug classes included in the 2019 paragraph (b)(1)(iii) applies to plan section 1343 of the PPACA that transfers benefit year adult models, and selections made in 2013, and is funds from lower risk, non- incorporation of the 2016 benefit year therefore no longer necessary. We grandfathered plans to higher risk, non- enrollee-level EDGE data in the 2019 received no comments regarding this grandfathered plans in the individual benefit year risk adjustment model proposal, and are finalizing these and small group markets, inside and recalibration. changes as proposed. outside the Exchanges. In accordance i. Recalibration Using EDGE Data B. Part 153—Standards Related to with § 153.310(a), a State that is approved or conditionally approved by To recalibrate the 2016, 2017 and Reinsurance, Risk Corridors, and Risk 2018 benefit year risk adjustment Adjustment Under the Affordable Care the Secretary to operate an Exchange may establish a risk adjustment models, we used the 3 most recent years Act ® program, or have HHS do so on its of Truven MarketScan data. This 1. Sequestration behalf. Beginning with the 2017 benefit approach allowed for using the blended, In accordance with the OMB Report to year, HHS is operating risk adjustment or averaged, coefficients from 3 years of Congress on the Joint Committee in every State, and did not receive any separately solved models, which promotes stability for the risk Reductions for Fiscal Year 2018,11 both applications from States to operate risk adjustment coefficients year-to-year, the transitional reinsurance program adjustment for the 2019 benefit year. particularly for rare conditions with and permanent risk adjustment program a. Overview of the HHS Risk small sample sizes. We finalized in the are subject to the fiscal year 2018 Adjustment Model (§ 153.320) 2018 Payment Notice the collection of sequestration. The Federal government’s The HHS risk adjustment model enrollee-level EDGE data and the 2018 fiscal year began October 1, 2017. predicts plan liability for an average recalibration of the risk adjustment Although the 2016 benefit year was the enrollee based on that person’s age, sex, model for the 2019 benefit year using final year of the transitional reinsurance and diagnoses (risk factors), producing a 2016 benefit year EDGE data. We believe program, HHS will continue to make risk score. The HHS risk adjustment that blending the coefficients calculated

11 methodology utilizes separate models from the 2016 benefit year enrollee-level Available at https://www.whitehouse.gov/sites/ ® whitehouse.gov/files/omb/sequestration_reports/ for adults, children, and infants to EDGE data with MarketScan data will 2018_jc_sequestration_report_may2017_potus.pdf. account for cost differences in each of provide stability within the risk

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adjustment program and minimize coefficients from the 2014 MarketScan®, to differences in the datasets’ volatility in changes to risk scores from 2015 MarketScan®, and 2016 enrollee- underlying populations. Another the 2018 to 2019 benefit years due to level EDGE data for the final commenter requested that recalibration differences in the datasets’ underlying coefficients, instead of using only the using EDGE data be postponed until all populations. As such, we proposed 2016 enrollee-level EDGE data to States’ data is available in the 2017 blending 3 years of data to recalibrate recalibrate the risk adjustment model benefit year.13 Some commenters the coefficients used in the risk coefficients for the 2019 benefit year. requested separate publication of the adjustment models and, for the 2019 We are finalizing the approach using coefficients from the 2016 enrollee-level benefit year, blending separately solved equally blended coefficients from EDGE data. One commenter requested coefficients from the 2016 benefit year separately solved 2014 MarketScan®, ® clarification as to what weights would enrollee-level EDGE data and the 2014 2015 MarketScan , and 2016 enrollee- be applied in blending coefficients from ® and 2015 MarketScan data. level EDGE data to recalibrate the risk the 3 years of data. Most commenters Given the timing of the proposed rule, adjustment model coefficients for the also supported HHS finalizing the 2019 we were not able to incorporate the 2019 benefit year. We are not making benefit year coefficients prior to rate 2016 benefit year enrollee-level EDGE any changes to age-sex or HCC setting in guidance, while a few others data in the proposed rule. Instead, we categories, because we did not find ® requested the coefficients be finalized in used the 2014 and 2015 MarketScan significant distributional differences, the final rule. One commenter noted data for the coefficients displayed in the and we will continue to assess whether that delaying publication of the final proposed rule. We proposed to finalize to propose any specific changes to the coefficients past the publication of the the 2019 benefit year blended categories for future benefit years in final rule would pose challenges in coefficients with the separately solved future rulemaking. We did not propose issuers’ rate setting timelines, while models from the 2016 benefit year and are not making any changes to the some commenters suggested that if HHS enrollee-level EDGE data, and the 2014 enrollment duration categories. Please needs additional time beyond the and 2015 MarketScan® data. This is see the preamble section below on publication of the final rule, the final similar to our approach in previous ‘‘Prescription Drugs’’ for a discussion of years, in which we updated the final changes being finalized with respect to coefficients for the 2019 benefit year coefficients using data from the most the RXC categories. The final risk should be published no later than recently available benefit year.12 We adjustment model coefficients for the February 28, 2018. explained that we expected to publish 2019 benefit year risk adjustment Response: For small sample sizes, the final risk adjustment model program are listed in Tables 2, 4 and 5 year-to-year differences in spending due coefficients for the 2019 benefit year in of this rule. to data anomalies can cause significant the final rule. However, we sought Comment: Commenters supported the differences in a particular solved comment on whether we should publish use of enrollee-level EDGE data in coefficient. We agree that blending the final risk adjustment model model recalibration noting the data coefficients from multiple years of data coefficients in guidance in the spring of would more closely reflect the relative can provide stability in changes in the 2018, prior to rate setting for the 2019 risk differences of individuals in the recalibrated model coefficients and benefit year, if we needed additional individual and small group markets provide certainty to issuers, particularly ® time to analyze the 2016 enrollee-level compared to the MarketScan data. where small sample sizes could lead to EDGE data. Under either approach, we Most commenters also supported volatility in the solved coefficients from proposed that the final risk adjustment equally blending coefficients from year-to-year. Additionally, while there model coefficients for the 2019 benefit separately solved models using 3 years are differences in total spending in year would be determined using the of data to promote stability year over MarketScan® compared to enrollee-level methodology that we would finalize in year, thereby phasing in the use of EDGE data, we have found that the this rule, and would be published prior enrollee-level EDGE data. A few relative risk differences for age-sex, HCC to the 2019 benefit year rate setting. commenters supported overweighting and RXC categories are generally similar Additionally, if we found significant the 2016 enrollee-level EDGE data, with to those in the MarketScan® data, and demographic or distributional one commenter supporting therefore, do not believe that blending differences in the enrollee-level EDGE overweighting of the 2016 data if sample the data will cause significant over- or ® data compared to the MarketScan data, sizes are adequate. A few commenters under-prediction of relative risk scores we sought comment on whether we supported using only the 2016 enrollee- on average. Enrollee-level EDGE data should make adjustments to the risk level EDGE data for recalibration, stating ® shows lower spending and relative risk adjustment recalibration model age-sex, that MarketScan data will have patterns for shorter enrollment hierarchical condition categories different utilization and risk patterns, durations compared to the MarketScan® (HCCs), and RXC categories for the 2019 and socioeconomic status for enrollees data, resulting in smaller enrollment benefit year. In such a case, we with employer-based coverage than the duration coefficients for all 11 months. proposed we would make adjustments EDGE data, which directly reflects This result was expected, given that to the models to better align them with PPACA individual and small group enrollees in large group coverage have the enrollee-level EDGE data, to market enrollees. These commenters longer enrollment duration and a higher improve the prediction of plan liability. also stated that these differences in the proportion of individuals with a full- We sought comment on our proposal underlying data could cause the risk year of enrollment on average than to determine coefficients based on a adjustment coefficients to over- or enrollees in the individual and small ® blend of 2014 and 2015 MarketScan under-predict risk differences. One group markets, and that the greater commenter stated that relying on older data and 2016 enrollee-level EDGE data. number of shorter average enrollment data to calibrate the model could lead to We also sought comment on the durations in the enrollee-level EDGE proposed methodology to equally significant gaps in the risk adjustment methodology. One commenter requested weight the separately solved model 13 Massachusetts is not included in the 2016 clarification as to the volatility in benefit year enrollee-level EDGE data, because 12 See, for example, 2018 Payment Notice, 81 FR changes to risk scores from the 2018 to Massachusetts operated its own risk adjustment 94058 (December 22, 2016). 2019 benefit years that could occur due program through the 2016 benefit year.

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data account for lower relative risk on enrolled in individual and small group EDGE data, which provides more average. market coverage, and will continue to granular claims data from the individual Additionally, while Massachusetts is do so for the 2019 benefit year. We will and small group markets, and is being not included in the 2016 benefit year consider whether to propose expanding used to improve the recalibration of enrollee-level EDGE data, the relative the age and sex factors to include age HHS programs. Additionally, as noted risk differences for enrollees in groups and associated costs for enrollees in the 2018 Payment Notice, HHS Massachusetts are likely similar on ages 65 and above in future model recognizes the sensitivity of enrollee- average to those for enrollees in other recalibrations. We also excluded level EDGE data, and is not collecting States. The 2017 benefit year enrollee- derived claims, any newborn diagnoses masked enrollee IDs from issuers’ EDGE level risk EDGE data will not be for infants older than one year of age, servers, plan or issuer IDs, rating areas, available until the end of summer 2018, anomalous claims (for example, or State data elements to safeguard the after the 2019 benefit year risk pregnancy diagnoses if sex is male) and privacy and security of protected health adjustment factors need to be published those with sex unknown. There were information (PHI) and minimize to support 2019 benefit year benefit approximately 47 million, 28 million potential risks to issuers’ proprietary design and rate development, and and 31 million total unique enrollees in information. therefore cannot be used for this the 2014 MarketScan®, 2015 ii. Prescription Drugs recalibration effort. We believe that a MarketScan®, and 2016 enrollee-level national dataset of individual and small EDGE data, respectively. Relative risks In the 2018 Payment Notice, we group market claims experience for the were similar in the 2016 enrollee-level finalized the inclusion of 12 RXCs that most recent benefit year is the preferable EDGE data for most categories in all interact with HCCs, or drug-diagnosis data source—even without the three adult, infant and child samples. (RXC–HCC) pairs, in the adult risk incorporation of one State—compared to As mentioned above, enrollee-level adjustment models for the 2018 benefit only using commercial claims data for EDGE data reflected lower spending and year. Ten of the RXC–HCC pairs have risk adjustment model recalibration and relative risk patterns for shorter three levels of incremental predicted risk estimation in the individual and enrollment duration enrollees compared costs (diagnosis-only, prescription drug- small group markets. to MarketScan® data. only, and both diagnosis and In all, we believe blending the Comment: In case of significant prescription drug), indicating that they coefficients promotes stability and demographic or distributional can be used to impute a particular certainty for issuers in rate setting, differences in the EDGE data compared diagnosis. The 2018 benefit year risk smoothing any significant differences as to the MarketScan® data, most adjustment adult models also included with the EDGE enrollment duration commenters supported HHS making two RXC–HCC pairs that are used for factors, while maintaining the relative adjustments to give greater weight to the severity-only—that is, they predict average risk differences stakeholders EDGE data when recalibrating the model incremental costs for enrollees with the have expected from the MarketScan®- coefficients. However, commenters did diagnosis-only, or with both the only coefficients. Therefore, we are not support making changes to the age- diagnosis and the prescription drug. For finalizing our proposal to equally sex, HCC, enrollment duration or RXC enrollees without the associated weight coefficients from separately factors categorizations beyond what was diagnoses documented for these solved models using 2014 MarketScan®, in the proposed rule, and instead severity-only RXC–HCC pairs, the 2015 MarketScan®, and 2016 enrollee- supported such changes to be presence of the drug alone would not level EDGE data for the final 2019 implemented for the 2020 benefit year. lead to the attribution of additional plan benefit year risk adjustment model Response: We did not identify liability costs to the plan. recalibration. We also were able to significant differences in the relative For the 2019 benefit year, we complete our analysis of the 2016 EDGE risk for enrollees over 65 compared to proposed to remove the two severity- data in time to publish the final those in the 60–64 age group in the only RXCs (RXC 11: Ammonia coefficients blended with 2016 enrollee- enrollee-level EDGE data compared to Detoxicants, and RXC 12: Diuretics, level EDGE data in this final rule. The the MarketScan® data, and therefore, are Loop and Select Potassium-Sparing). final 2019 benefit year risk adjustment finalizing the risk adjustment model Both have low average costs per enrollee model coefficients listed in Tables 2, 4, categories as proposed. As noted above, per year and were constrained in the and 5 are blended coefficients using we will continue to assess relative 2018 benefit year adult risk adjustment equally weighted coefficients solved differences in demographic and models final coefficients to the average from the 2014 MarketScan®, 2015 spending patterns in the EDGE data and cost of the drugs to avoid MarketScan®, and 2016 enrollee-level will consider amending the risk overcompensating issuers for these EDGE data. adjustment model categories in future RXCs. Constraining these RXCs removed Comment: Commenters requested recalibrations, particularly once we overprescribing and gaming incentives clarification on the analytical dataset have multiple years of enrollee-level to prescribe a low-cost drug to receive development process using the 2016 EDGE data. a much larger risk adjustment payment. enrollee-level EDGE data, sample size of Comment: A few commenters However, after constraints, these two the enrollee-level EDGE data, and requested that HHS limit the scope of severity-only RXCs have extremely differences in EDGE and MarketScan® enrollee-level EDGE data collection and small coefficients that no longer predict data. use, clarify the types of data elements meaningful incremental plan risk Response: We arrived at the 2016 collected in the enrollee-level EDGE associated with a severe health enrollee-level EDGE analytical dataset data, proceed with caution given the condition. Therefore, we proposed using several criteria. We limited the data privacy and trade secret eliminating these two RXCs from the sample to ages 0–64 to maintain the information, and prohibit any other use adult models beginning with the 2019 same age categories as those HHS has of the data. benefit year. As explained in the used in the MarketScan® data, with Response: These comments are proposed rule, we believe the remaining which the EDGE coefficients are outside the scope of the proposed rule. RXCs do not engender significant blended. Currently, we use the age 60– As finalized in the 2018 Payment gaming concerns due to the cost and 64 factors for those over 65 years of age Notice, HHS is collecting enrollee-level side-effects of the drugs if prescribed

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without cause. As we noted in the 2018 release a mapping of RXCUIs to RXC of RXCUIs that would be included for Payment Notice, where the risk of factors for issuers to adequately assess 2018 benefit year risk adjustment adult unintended effects on provider how inclusion and exclusion of drugs models in the HHS-operated risk prescribing behavior is low, we will will impact risk adjustment, and adjustment program. As we noted in the continue to include a small number of suggested HHS provide a crosswalk crosswalk, drugs were excluded based prescription drug classes as predictors with the RXCUIs mapped to the RXCs on expert or clinician input as to drugs’ of risk and plan liability. For the prior to January 1, 2018. The commenter cross indications, empirical and remaining RXCs, we explained there is also noted that since there is a lag in the statistical analyses that indicated a weak a high rate of presence of a diagnosis data used for recalibration, HHS should association between the drug and the code in the associated HCC in the consider how to incorporate newer diagnoses, or if drugs were older or MarketScan® data, indicating a positive drugs that are approved after the data discontinued. Drugs were also excluded predictive value for using these RXCs to years and before or during the benefit in situations where drugs had impute missing diagnoses. Additionally, year. On the other hand, commenters substantially lower costs compared to we noted that we intend to monitor who had a chance to review the draft other drugs included in the RXC, and prescription drug utilization for RXC crosswalk HHS released in therefore these drugs were less likely to unintended effects, and may propose to September 2017 for the 2018 benefit be the focus of risk-selection behavior remove drug classes based on such year risk adjustment adult models by health plans. In these instances, USP evidence in future rulemaking. We are suggested that if a drug is included, then classes contained a mix of newer, more finalizing the removal of RXC11 and all strengths and formulations of that expensive drug treatments, and older, RXC12 from the adult risk adjustment drug ought to be included in the drug often generic, lower-cost drug models beginning with the 2019 benefit class, including the generic or brand treatments. For example, the combined year. Table 1 contains the final list of name drugs, or requested clarification as USP classes Immune Suppressants and prescription drug factors included in the to why specific drugs were excluded. A Immunomodulators encompass a wide 2019 benefit year risk adjustment adult few commenters requested that HHS range of drugs. They include expensive models. We will continue to evaluate consider including prescription drugs biologics costing several thousands of the effects of incorporating prescription used by individuals with mental health dollars each month and drugs like drugs in the adult models to determine and substance use disorders in the generic methotrexate, a month’s supply whether to continue, broaden or reduce model, with one suggesting that adding of which can cost less than $100. the impact of this set of factors. drugs used by those with mental health Clinician review determined that many and substance use disorders to the of the drugs in this class are Comment: Most commenters model may better capture the costs substitutable and the general prescribing supported the removal of the two associated with these individuals, and process would be to first prescribe a severity-only RXCs due to their low citing a study suggesting that those costs cheaper drug, and if the patient does not impact in predicting meaningful may not be well captured in the respond to that then move to a more differences in risk. Commenters also associated HCCs in the current model.14 expensive biologic. However, because supported HHS’s intention to evaluate Response: We are finalizing our concern over patient access and health the impact of incorporating the proposal to remove the two severity- plan selection behavior (reflected in prescription drug factors in the model only RXCs (RXC 11: Ammonia formulary design) centers around the and adding or removing drugs in future Detoxicants, and RXC 12: Diuretics, expensive biologics, the cheaper non- model recalibrations as appropriate. Loop and Select Potassium-Sparing) biologics were removed from RXC 9. Commenters generally supported the from the 2019 benefit year risk We review drugs in the United States inclusion of prescription drug factors in adjustment adult models. As we Pharmacopeia (USP) classification and the HHS risk adjustment model, noting explained in the 2018 Payment Notice, consult clinicians and experts to ensure the benefit in imputing missing we selected the RxNorm tool developed relevant drugs are included. However, diagnoses. Additionally, we note that by the U.S. National Library of Medicine as some commenters noted in response commenters on the Request for because it is frequently updated, to the proposed rule, new drugs have Information also supported the reliable, and easily accessible, and been released since we released the inclusion of prescription drugs in the issuers commented on the ease of the draft 2018 benefit year crosswalk and a risk adjustment methodology. One RxNorm tool in mapping drugs to few drugs that may be eligible under our commenter to the proposed rule RXCUIs. As such, we do not see a need other criteria were not classified by the suggested HHS should use the MedID to adopt another classification system at USP classification version used for the for drug classification instead of the this time. HHS posted an RXC to RXCUI draft crosswalk. We expect to publish RXNorm Concept Unique Identifier draft crosswalk on September 18, the final 2018 benefit year crosswalk in (RXCUI) system. The commenter noted 2017,15 to provide issuers an initial set the spring of 2019, after the conclusion MedID would improve stability, of the 2018 benefit year, so that newly accessibility and predictability of the 14 Montz, E., Layton, T., Busch, A.B., Ellis, R.P., approved drugs released through the RXCs, as acquiring RXCUI mapping, Rose, S., & McGuire, T.G. (2016). Risk-adjustment end of the year and the latest USP keeping it up to-date, anticipating simulation: Plans may have incentives to distort mental health and substance use coverage. Health classification are evaluated and changes and ensuring drug inclusion Affairs, 35(6), 1022–1028. included, as appropriate. As such, we has been a challenge for issuers in 15 Creation of the 2018 Benefit Year HHS- intend to make quarterly updates to the determining formularies and often Operated Risk Adjustment Adult Models Draft 2018 benefit year prescription drug excludes some drugs. Another Prescription Drug (RXCUIs) to HHS Drug Classes (RXCs) Crosswalk Memorandum. September 18, crosswalk, to ensure we are capturing commenter sought clarification as to 2017. Available at https://www.cms.gov/CCIIO/ all new drug releases and drug class whether drugs administered through Resources/Regulations-and-Guidance/Downloads/ inclusions or modifications. We are also hospital, office-based or home health Draft-RxC-Crosswalk-Memo-9-18-17.pdf. reviewing drugs administered through settings and found on medical claims 2018 Benefit Year HHS-Operated Risk clinicians in hospital, office-based, or would receive credit for the RXC factors, Adjustment Adult Models Draft Prescription Drug (RXCUIs) to HHS Drug Classes (RXCs) Crosswalk. in addition to drugs found on pharmacy September 18, 2017. Available at https:// Guidance/Downloads/RARx_RxCUIs-Crosswalk-9- claims. One commenter requested HHS www.cms.gov/CCIIO/Resources/Regulations-and- 6-17.xlsx.

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home health settings crosswalked to antimanic agents for depression and with the intent of determining whether national drug codes (NDCs) to bipolar disorders due to their low a clinician correctly diagnosed a patient. determine whether it is appropriate imputation value in identifying the risk Rather, the goal for the HHS-operated under our inclusion criteria to include solely based on the RXC and low risk adjustment program is to ensure these drugs in the 2018 benefit year relative cost of the drugs. We are that enrollees’ diagnoses on paid claims crosswalk for 2018 benefit year risk continuing to assess if mental health reflect the appropriately assigned HCCs, adjustment risk score calculation. and substance use disorder treatments and were diagnosed by a licensed However, as these drugs are often more should be included in the adult models clinician. Likewise, in validating expensive when administered in in future benefit years. pharmacy claims, we intend to validate hospital, office-based, or home health Comment: One commenter noted that factors such as whether the prescription settings, we are not including such pharmacy claims should not be was filled and paid by the issuer, and drugs in the recalibration of the adult included in the risk adjustment data models for the 2019 benefit year to limit validation process as no clinical whether the appropriate RXC gaming incentives. We anticipate the documentation is available for interaction was assigned. We 2019 benefit year drug crosswalk will be pharmacy claims, and HHS should not understand commenters’ concerns published on a similar quarterly include data that cannot be easily regarding prescription drug data and schedule, following the final 2018 audited in risk adjustment. Another intend to closely monitor prescribing benefit year crosswalk publication. We commenter sought clarification as to behavior in the 2018 benefit year and also intend to monitor the impact of the how HHS intends to conduct risk beyond. We will consider whether drugs included in the adult models on adjustment data validation for additional adjustments to the risk prescribing incentives and will evaluate prescription drugs included in the risk adjustment data validation process are adding or removing other RXCs as adjustment adult models. needed for the 2018 benefit year to appropriate in future recalibrations for Response: As we noted in the 2018 ensure risk adjustment data validation future benefit years. We had previously Payment Notice, HHS does not perform appropriately audits pharmacy claims considered, but did not include, risk adjustment data validation audits submitted to EDGE by issuers.

TABLE 1—FINAL DRUG-DIAGNOSIS (RXC–HCC) PAIRS FOR THE 2019 ADULT MODEL

RXC RXC label HCC HCC label Final RXC use

RXC 01 ...... Anti-HIV Agents ...... 001 ...... HIV/AIDS ...... imputation/severity. RXC 02 ...... Anti-Hepatitis C (HCV) 037C, 036, 035, 034 Chronic Hepatitis C, Cirrhosis of Liver, End-Stage imputation/severity. Agents. Liver Disease, and Liver Transplant Status/Com- plications. RXC 03 ...... Antiarrhythmics ...... 142 ...... Specified Heart Arrhythmias ...... imputation/severity. RXC 04 ...... Phosphate Binders ...... 184, 183, 187, 188 .. End Stage Renal Disease, Kidney Transplant Status, imputation/severity. Chronic Kidney Disease, Stage 5, Chronic Kidney Disease, Severe (Stage 4). RXC 05 ...... Inflammatory Bowel Dis- 048, 041 ...... Inflammatory Bowel Disease, Intestine Transplant imputation/severity. ease Agents. Status/Complications. RXC 06 ...... Insulin ...... 019, 020, 021, 018 .. Diabetes with Acute Complications; Diabetes with imputation/severity. Chronic Complications; Diabetes without Com- plication, Pancreas Transplant Status/Complica- tions. RXC 07 ...... Anti-Diabetic Agents, Ex- 019, 020, 021, 018 .. Diabetes with Acute Complications, Diabetes with imputation/severity. cept Insulin and Chronic Complications, Diabetes without Com- Metformin Only. plication, Pancreas Transplant Status/Complica- tions. RXC 08 ...... Multiple Sclerosis Agents 118 ...... Multiple Sclerosis ...... imputation/severity. RXC 09 ...... Immune Suppressants 056, 057, 048, 041 .. Rheumatoid Arthritis and Specified Autoimmune Dis- imputation/severity. and Immunomodulators. orders, Systemic Lupus Erythematosus and Other Autoimmune Disorders, Inflammatory Bowel Dis- ease, Intestine Transplant Status/Complications. RXC 10 ...... Cystic Fibrosis Agents ..... 159, 158 ...... Cystic Fibrosis, Lung Transplant Status/Complica- imputation/severity. tions.

iii. High-Cost Risk Pool Adjustment adjustment factors are calculated high-cost enrollees will receive a without the high-cost risk, because the payment for the percentage of costs HHS finalized a high-cost risk pool average risk associated with HCCs and above the threshold in their respective adjustment in the 2018 Payment Notice RXCs is better accounted for without the transfers. Using claims data submitted to account for the incorporation of risk inclusion of the high-cost enrollees. In to the EDGE server by issuers of risk associated with high-cost enrollees in addition, to account for issuers’ risk adjustment covered plans, HHS will the risk adjustment model. Specifically, associated with the high-cost enrollees, calculate the total amount of paid we finalized adjusting the risk issuers will be compensated for a claims costs for high-cost enrollees adjustment model for high-cost percentage of costs above the threshold. based on the threshold and the enrollees beginning for the 2018 benefit We set the threshold and percentage of coinsurance rate. HHS will then year by excluding a percentage of costs costs at a level that would continue to calculate a charge as a percentage of the above a certain threshold level in the incentivize issuers to control costs issuers’ total premiums in the calculation of enrollee-level plan while improving the risk prediction of individual (including catastrophic and liability risk scores so that risk the risk adjustment model. Issuers with non-catastrophic plans and merged

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market plans), or small group markets, based on what appears to be a c. List of Factors To Be Employed in the which will be applied to the total misunderstanding that the high-cost risk Risk Adjustment Model (§ 153.320) transfer amount in that market, pool adjustment requires individuals to The final factors resulting from the maintaining the balance of payments pay 40 percent of costs above $1 equally weighted blended factors from and charges within the risk adjustment million. Some commenters did not the 2014 and 2015 MarketScan® data program. In the 2018 Payment Notice, support tiering the high-cost risk pool and the 2016 enrollee-level EDGE data we finalized a threshold of $1 million adjustment program for the 2019 benefit separately solved models (with the and a coinsurance rate of 60 percent year without the first year of experience incorporation of the partial year across all States for the individual with this adjustment, noting it would enrollment adjustment and prescription lead to additional complexity. One (including catastrophic and non- drugs reflected in the adult models catastrophic plans and merged market commenter supported a tiered approach only) are shown in Tables 2, 4, and 5. plans) and small group markets for the in parameters with maximum The adult, child and infant models have 2018 benefit year. coinsurance rates of 80 to 90 percent been truncated to account for the high- For the 2019 benefit year, we phased in over multiple years, and cost enrollee pool payment parameters proposed to maintain the same another commenter supported a tiered by removing 60 percent of costs above parameters that apply to the 2018 approach if the approach and the $1 million threshold as finalized in benefit year. Therefore, we proposed to parameters result in an equivalent cost this rule. As discussed in the preceding maintain a $1 million threshold and 60 and scope as the $1 million threshold section, we are finalizing our proposal percent coinsurance rate for the high- and 60 percent coinsurance rate cost risk pool for the 2019 benefit year parameters. to keep the 2019 benefit year high-cost risk adjustment program. We explained Response: As we noted in the 2018 enrollee risk pool payment parameters that we believe this threshold and Payment Notice, removing extremely the same as those finalized for the 2018 coinsurance rate would result in total high costs improves the risk adjustment benefit year. The final factors for the payments or charges nationally that are model’s predictive ability. Additionally, adult models also reflect the removal of very small as a percentage of premiums the high-cost risk pool adjustment to the the two severity-only RXCs (RXC 11: for issuers, and will prevent States and transfer formula mitigates issuers’ risk Ammonia Detoxicants, and RXC 12: issuers with very high-cost enrollees selection incentives to avoid high-cost Diuretics, Loop and Select Potassium- from bearing a disproportionate amount risk enrollees. Because high-cost Sparing) discussed above in the of unpredictable risk. We sought enrollees are outliers and thus, preamble section on ‘‘Prescription comments on alternative methods for unpredictable, they have the potential to Drugs.’’ Table 2 contains factors for each reimbursing issuers for exceptionally significantly distort risk in smaller adult model, including the age-sex, high-cost enrollees through the high- markets. Removing the high-cost risk HCCs, RXCs, HCC–RXC interaction, and cost risk pool and improving the from the recalibration model and enrollment duration coefficients. As we calculation of plan liability in the HHS- separately adjusting transfers will allow previously noted,16 some interactions of operated risk adjustment models for for greater stability in risk scores to RXCs and HCCs have negative future benefit years. We also shared compensate issuers for predictable risk coefficients; however, this does not suggestions from stakeholders that the and transfers to compensate issuers for mean that an enrollee’s risk score pool be multi-tiered, with multiple unpredictable risk. We will consider decreases due to the presence of an thresholds and increased coinsurance as whether a tiered approach would RXC, an HCC, or both. the thresholds increase to account for improve model prediction and better Table 3 contains the HHS HCCs in the the reduced number of enrollees at compensate issuers for high-cost severity illness indicator variable. Table higher thresholds where costs to an enrollees than the current approach for 4 contains the factors for each child issuer are catastrophic. future benefit years. We are continuing model. Table 5 contains the factors for We are finalizing the high-cost risk to assess the market impact of tiered each infant model. Tables 6 and 7 pool adjustment parameters for the 2019 approaches nationally on the model’s contain the HCCs included in the infant benefit year as proposed. risk prediction and issuers’ risk model maturity and severity categories, Comment: Most commenters differences, and whether such an respectively. supported our proposal to maintain the approach would meaningfully improve Comment: A few commenters same high-cost risk pool adjustment the model in accounting for high-cost requested for HHS to separately publish parameters as those used for the 2018 enrollees’ risk. We continue to believe a the coefficients solved only from the benefit year and noted that keeping the $1 million threshold and 60 percent 2016 enrollee-level EDGE data. parameters the same provides stability coinsurance rate for the 2019 benefit Response: We are not separately and certainty in the markets. One year are appropriate to incentivize publishing the coefficients from only 1 commenter questioned why the issuers to control costs while improving year of data to avoid any confusion that parameters are not trended for the risk adjustment model’s risk could be caused from publishing two increasing medical costs. Some prediction. Additionally, as we noted in sets of coefficients in the final rule. commenters noted that the $1 million the 2018 Payment Notice, if an issuer However, we note that stakeholders threshold level may be too high to have were to fail the data quality analysis for interested in coefficients from the 2016 any meaningful impact on premiums or a risk adjustment transfer and be enrollee-level EDGE data will be able to provide stability in smaller State assessed a default charge under solve for them based on the proposed markets with low claims costs that § 153.740(b) on that basis, we would and finalized coefficients. We published would have additional charges assessed, perform additional data quality analysis the model coefficients using equally which could cause volatility. A few to determine an issuer’s eligibility for weighted coefficients solved from the commenters did not support the high- high-cost risk pool adjustments. cost risk pool adjustment to transfers, We are finalizing our proposal to 16 2018 Benefit Year Final HHS Risk Adjustment yet one of these commenters supported maintain a $1 million threshold and 60 Model Coefficients. April 18, 2017. Available at https://www.cms.gov/CCIIO/Programs-and- the removal of these costs from the risk percent coinsurance rate for the high- Initiatives/Premium-Stabilization-Programs/ adjustment model recalibration. One cost risk pool for the 2019 benefit year Downloads/2018-Benefit-Year-Final-HHS-Risk- commenter did not support the proposal risk adjustment program. Adjustment-Model-Coefficients.pdf.

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2014 and 2015 MarketScan® data in the enrollee-level EDGE data without equally weighted coefficients solved proposed rule. The coefficients finalized changing the coefficients solved from from the 3 years of data. in Tables 2, 4 and 5 include the the 2014 and 2015 MarketScan® data coefficients solved from the 2016 published in the proposed rule, and TABLE 2—FINAL ADULT RISK ADJUSTMENT MODEL FACTORS FOR 2019 BENEFIT YEAR

HCC or RXC No. Factor Platinum Gold Silver Bronze Catastrophic

Demographic Factors

Age 21–24, Male ...... 0.167 0.133 0.091 0.051 0.048 Age 25–29, Male ...... 0.153 0.119 0.078 0.037 0.034 Age 30–34, Male ...... 0.186 0.144 0.093 0.043 0.039 Age 35–39, Male ...... 0.236 0.185 0.125 0.063 0.058 Age 40–44, Male ...... 0.292 0.233 0.164 0.093 0.088 Age 45–49, Male ...... 0.346 0.280 0.202 0.121 0.115 Age 50–54, Male ...... 0.455 0.378 0.287 0.192 0.184 Age 55–59, Male ...... 0.511 0.424 0.324 0.217 0.209 Age 60–64, Male ...... 0.573 0.473 0.359 0.235 0.225 Age 21–24, Female ...... 0.269 0.218 0.153 0.088 0.083 Age 25–29, Female ...... 0.304 0.245 0.173 0.098 0.092 Age 30–34, Female ...... 0.410 0.338 0.253 0.167 0.160 Age 35–39, Female ...... 0.491 0.410 0.317 0.226 0.219 Age 40–44, Female ...... 0.545 0.454 0.352 0.249 0.241 Age 45–49, Female ...... 0.553 0.458 0.350 0.237 0.229 Age 50–54, Female ...... 0.616 0.516 0.401 0.278 0.268 Age 55–59, Female ...... 0.601 0.499 0.380 0.252 0.241 Age 60–64, Female ...... 0.616 0.505 0.379 0.240 0.229

Diagnosis Factors

HCC001 ...... HIV/AIDS ...... 0.626 0.529 0.434 0.359 0.352 HCC002 ...... Septicemia, Sepsis, Systemic Inflammatory Response Syndrome/Shock .. 8.000 7.812 7.688 7.731 7.737 HCC003 ...... Central Nervous System Infections, Except Viral Meningitis ...... 5.750 5.666 5.604 5.625 5.626 HCC004 ...... Viral or Unspecified Meningitis ...... 4.396 4.192 4.060 3.989 3.983 HCC006 ...... Opportunistic Infections ...... 6.143 6.060 6.006 5.972 5.968 HCC008 ...... Metastatic Cancer ...... 21.806 21.372 21.040 21.084 21.087 HCC009 ...... Lung, Brain, and Other Severe Cancers, Including Pediatric Acute 12.392 12.068 11.825 11.807 11.804 Lymphoid Leukemia. HCC010 ...... Non-Hodgkin‘s Lymphomas and Other Cancers and Tumors ...... 5.575 5.356 5.189 5.117 5.110 HCC011 ...... Colorectal, Breast (Age <50), Kidney, and Other Cancers ...... 4.291 4.074 3.905 3.831 3.823 HCC012 ...... Breast (Age 50+) and Prostate Cancer, Benign/Uncertain Brain Tumors, 2.640 2.482 2.356 2.283 2.276 and Other Cancers and Tumors. HCC013 ...... Thyroid Cancer, Melanoma, Neurofibromatosis, and Other Cancers and 1.211 1.084 0.976 0.860 0.849 Tumors. HCC018 ...... Pancreas Transplant Status/Complications ...... 4.439 4.246 4.114 4.122 4.122 HCC019 ...... Diabetes with Acute Complications ...... 0.603 0.531 0.463 0.389 0.381 HCC020 ...... Diabetes with Chronic Complications ...... 0.603 0.531 0.463 0.389 0.381 HCC021 ...... Diabetes without Complication ...... 0.603 0.531 0.463 0.389 0.381 HCC023 ...... Protein-Calorie Malnutrition ...... 11.438 11.430 11.416 11.494 11.502 HCC026 ...... Mucopolysaccharidosis ...... 2.380 2.280 2.200 2.137 2.132 HCC027 ...... Lipidoses and Glycogenosis ...... 2.380 2.280 2.200 2.137 2.132 HCC029 ...... Amyloidosis, Porphyria, and Other Metabolic Disorders ...... NA NA NA NA NA HCC030 ...... Adrenal, Pituitary, and Other Significant Endocrine Disorders ...... 2.380 2.280 2.200 2.137 2.132 HCC034 ...... Liver Transplant Status/Complications ...... 2.380 2.280 2.200 2.137 2.132 HCC035 ...... End-Stage Liver Disease ...... 10.515 10.418 10.353 10.334 10.331 HCC036 ...... Cirrhosis of Liver ...... 5.696 5.491 5.349 5.341 5.339 HCC037_1 ...... Chronic Viral Hepatitis C ...... 0.707 0.604 0.545 0.509 0.505 HCC037_2 ...... Chronic Hepatitis, Other/Unspecified ...... 0.703 0.584 0.523 0.474 0.469 HCC038 ...... Acute Liver Failure/Disease, Including Neonatal Hepatitis ...... 4.300 4.155 4.055 4.026 4.024 HCC041 ...... Intestine Transplant Status/Complications ...... 28.253 28.206 28.169 28.209 28.209 HCC042 ...... Peritonitis/Gastrointestinal Perforation/Necrotizing Enterocolitis ...... 9.718 9.488 9.318 9.328 9.329 HCC045 ...... Intestinal Obstruction ...... 5.510 5.274 5.115 5.104 5.102 HCC046 ...... Chronic Pancreatitis ...... 4.439 4.246 4.114 4.122 4.122 HCC047 ...... Acute Pancreatitis/Other Pancreatic Disorders and Intestinal Malabsorp- 2.243 2.085 1.972 1.896 1.888 tion. HCC048 ...... Inflammatory Bowel Disease ...... 2.192 2.011 1.868 1.765 1.755 HCC054 ...... Necrotizing Fasciitis ...... 5.507 5.332 5.200 5.206 5.207 HCC055 ...... Bone/Joint/Muscle Infections/Necrosis ...... 5.507 5.332 5.200 5.206 5.207 HCC056 ...... Rheumatoid Arthritis and Specified Autoimmune Disorders ...... 3.316 3.130 2.980 2.923 2.918 HCC057 ...... Systemic Lupus Erythematosus and Other Autoimmune Disorders ...... 0.993 0.878 0.780 0.666 0.654 HCC061 ...... Osteogenesis Imperfecta and Other Osteodystrophies ...... 2.654 2.477 2.337 2.257 2.249 HCC062 ...... Congenital/Developmental Skeletal and Connective Tissue Disorders ...... 2.654 2.477 2.337 2.257 2.249 HCC063 ...... Cleft Lip/Cleft Palate ...... 1.417 1.266 1.155 1.071 1.065 HCC066 ...... Hemophilia ...... 53.096 52.795 52.549 52.553 52.553 HCC067 ...... Myelodysplastic Syndromes and Myelofibrosis ...... 12.454 12.326 12.228 12.227 12.227 HCC068 ...... Aplastic Anemia ...... 12.454 12.326 12.228 12.227 12.227 HCC069 ...... Acquired Hemolytic Anemia, Including Hemolytic Disease of Newborn ..... 7.864 7.738 7.636 7.604 7.602 HCC070 ...... Sickle Cell Anemia (Hb–SS) ...... 7.864 7.738 7.636 7.604 7.602 HCC071 ...... Thalassemia Major ...... 7.864 7.738 7.636 7.604 7.602 HCC073 ...... Combined and Other Severe Immunodeficiencies ...... 5.198 5.074 4.982 4.979 4.979 HCC074 ...... Disorders of the Immune Mechanism ...... 5.198 5.074 4.982 4.979 4.979 HCC075 ...... Coagulation Defects and Other Specified Hematological Disorders ...... 2.657 2.572 2.503 2.464 2.461 HCC081 ...... Drug Psychosis ...... 3.804 3.574 3.401 3.278 3.265

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TABLE 2—FINAL ADULT RISK ADJUSTMENT MODEL FACTORS FOR 2019 BENEFIT YEAR—Continued

HCC or RXC No. Factor Platinum Gold Silver Bronze Catastrophic

HCC082 ...... Drug Dependence ...... 3.804 3.574 3.401 3.278 3.265 HCC087 ...... Schizophrenia ...... 3.057 2.822 2.651 2.559 2.550 HCC088 ...... Major Depressive and Bipolar Disorders ...... 1.624 1.472 1.350 1.231 1.219 HCC089 ...... Reactive and Unspecified Psychosis, Delusional Disorders ...... 1.624 1.472 1.350 1.231 1.219 HCC090 ...... Personality Disorders ...... 1.124 1.010 0.901 0.780 0.769 HCC094 ...... Anorexia/Bulimia Nervosa ...... 2.549 2.397 2.275 2.201 2.194 HCC096 ...... Prader-Willi, Patau, Edwards, and Autosomal Deletion Syndromes ...... 4.019 3.924 3.847 3.789 3.783 HCC097 ...... Down Syndrome, Fragile X, Other Chromosomal Anomalies, and Con- 1.056 0.963 0.880 0.802 0.795 genital Malformation Syndromes. HCC102 ...... Autistic Disorder ...... 1.124 1.010 0.901 0.780 0.769 HCC103 ...... Pervasive Developmental Disorders, Except Autistic Disorder ...... 1.124 1.010 0.901 0.780 0.769 HCC106 ...... Traumatic Complete Lesion Cervical Spinal Cord ...... 9.989 9.853 9.752 9.735 9.732 HCC107 ...... Quadriplegia ...... 9.989 9.853 9.752 9.735 9.732 HCC108 ...... Traumatic Complete Lesion Dorsal Spinal Cord ...... 7.568 7.420 7.310 7.278 7.274 HCC109 ...... Paraplegia ...... 7.568 7.420 7.310 7.278 7.274 HCC110 ...... Spinal Cord Disorders/Injuries ...... 5.212 5.008 4.857 4.816 4.812 HCC111 ...... Amyotrophic Lateral Sclerosis and Other Anterior Horn Cell Disease ...... 1.965 1.764 1.620 1.534 1.524 HCC112 ...... Quadriplegic Cerebral Palsy ...... 0.302 0.192 0.120 0.072 0.071 HCC113 ...... Cerebral Palsy, Except Quadriplegic ...... 0.255 0.176 0.120 0.072 0.071 HCC114 ...... Spina Bifida and Other Brain/Spinal/Nervous System Congenital Anoma- 0.355 0.300 0.265 0.241 0.236 lies. HCC115 ...... Myasthenia Gravis/Myoneural Disorders and Guillain-Barre Syndrome/In- 5.262 5.137 5.045 5.027 5.025 flammatory and Toxic Neuropathy. HCC117 ...... Muscular Dystrophy ...... 2.064 1.922 1.819 1.720 1.708 HCC118 ...... Multiple Sclerosis ...... 8.436 8.144 7.920 7.895 7.892 HCC119 ...... Parkinson’s, Huntington’s, and Spinocerebellar Disease, and Other 2.064 1.922 1.819 1.720 1.708 Neurodegenerative Disorders. HCC120 ...... Seizure Disorders and Convulsions ...... 1.390 1.248 1.138 1.044 1.035 HCC121 ...... Hydrocephalus ...... 5.922 5.814 5.724 5.696 5.694 HCC122 ...... Non-Traumatic Coma, and Brain Compression/Anoxic Damage ...... 8.310 8.176 8.067 8.059 8.058 HCC125 ...... Respirator Dependence/Tracheostomy Status ...... 26.626 26.590 26.555 26.637 26.644 HCC126 ...... Respiratory Arrest ...... 8.048 7.900 7.794 7.864 7.872 HCC127 ...... Cardio-Respiratory Failure and Shock, Including Respiratory Distress 8.048 7.900 7.794 7.864 7.872 Syndromes. HCC128 ...... Heart Assistive Device/Artificial Heart ...... 28.421 28.219 28.071 28.120 28.125 HCC129 ...... Heart Transplant ...... 28.421 28.219 28.071 28.120 28.125 HCC130 ...... Congestive Heart Failure ...... 2.800 2.705 2.635 2.624 2.623 HCC131 ...... Acute Myocardial Infarction ...... 8.077 7.789 7.577 7.664 7.672 HCC132 ...... Unstable Angina and Other Acute Ischemic Heart Disease ...... 4.820 4.558 4.388 4.378 4.378 HCC135 ...... Heart Infection/Inflammation, Except Rheumatic ...... 5.473 5.356 5.268 5.237 5.235 HCC142 ...... Specified Heart Arrhythmias ...... 2.467 2.335 2.233 2.158 2.150 HCC145 ...... Intracranial Hemorrhage ...... 7.621 7.366 7.186 7.162 7.159 HCC146 ...... Ischemic or Unspecified Stroke ...... 2.164 2.012 1.918 1.896 1.894 HCC149 ...... Cerebral Aneurysm and Arteriovenous Malformation ...... 3.167 2.994 2.869 2.802 2.796 HCC150 ...... Hemiplegia/Hemiparesis ...... 4.517 4.422 4.355 4.402 4.407 HCC151 ...... Monoplegia, Other Paralytic Syndromes ...... 2.734 2.612 2.525 2.486 2.482 HCC153 ...... Atherosclerosis of the Extremities with Ulceration or Gangrene ...... 9.056 8.976 8.915 9.004 9.013 HCC154 ...... Vascular Disease with Complications ...... 6.714 6.556 6.439 6.424 6.422 HCC156 ...... Pulmonary Embolism and Deep Vein Thrombosis ...... 3.352 3.207 3.101 3.044 3.038 HCC158 ...... Lung Transplant Status/Complications ...... 25.564 25.421 25.310 25.384 25.391 HCC159 ...... Cystic Fibrosis ...... 14.108 13.825 13.596 13.601 13.601 HCC160 ...... Chronic Obstructive Pulmonary Disease, Including Bronchiectasis ...... 0.878 0.776 0.686 0.591 0.582 HCC161 ...... Asthma ...... 0.878 0.776 0.686 0.591 0.582 HCC162 ...... Fibrosis of Lung and Other Lung Disorders ...... 1.869 1.767 1.693 1.639 1.633 HCC163 ...... Aspiration and Specified Bacterial Pneumonias and Other Severe Lung 6.270 6.223 6.188 6.194 6.195 Infections. HCC183 ...... Kidney Transplant Status ...... 7.462 7.260 7.119 7.070 7.064 HCC184 ...... End Stage Renal Disease ...... 29.905 29.678 29.495 29.641 29.654 HCC187 ...... Chronic Kidney Disease, Stage 5 ...... 1.319 1.263 1.224 1.233 1.235 HCC188 ...... Chronic Kidney Disease, Stage 4 ...... 1.319 1.263 1.224 1.233 1.235 HCC203 ...... Ectopic and Molar Pregnancy, Except with Renal Failure, Shock, or Em- 1.156 1.011 0.879 0.670 0.648 bolism. HCC204 ...... Miscarriage with Complications ...... 1.156 1.011 0.879 0.670 0.648 HCC205 ...... Miscarriage with No or Minor Complications ...... 1.156 1.011 0.879 0.670 0.648 HCC207 ...... Completed Pregnancy With Major Complications ...... 3.329 2.913 2.690 2.416 2.386 HCC208 ...... Completed Pregnancy With Complications ...... 3.329 2.913 2.690 2.416 2.386 HCC209 ...... Completed Pregnancy with No or Minor Complications ...... 3.329 2.913 2.690 2.416 2.386 HCC217 ...... Chronic Ulcer of Skin, Except Pressure ...... 1.988 1.888 1.818 1.798 1.796 HCC226 ...... Hip Fractures and Pathological Vertebral or Humerus Fractures ...... 8.801 8.587 8.428 8.457 8.460 HCC227 ...... Pathological Fractures, Except of Vertebrae, Hip, or Humerus ...... 3.874 3.744 3.644 3.579 3.575 HCC251 ...... Stem Cell, Including Bone Marrow, Transplant Status/Complications ...... 24.334 24.334 24.329 24.357 24.360 HCC253 ...... Artificial Openings for Feeding or Elimination ...... 8.284 8.198 8.131 8.164 8.168 HCC254 ...... Amputation Status, Lower Limb/Amputation Complications ...... 3.486 3.371 3.290 3.313 3.316

Interaction Factors

SEVERE x HCC006 ...... Severe illness x Opportunistic Infections ...... 7.694 7.897 8.035 8.180 8.193 SEVERE x HCC008 ...... Severe illness x Metastatic Cancer ...... 7.694 7.897 8.035 8.180 8.193 SEVERE x HCC009 ...... Severe illness x Lung, Brain, and Other Severe Cancers, Including Pedi- 7.694 7.897 8.035 8.180 8.193 atric Acute Lymphoid Leukemia. SEVERE x HCC010 ...... Severe illness x Non-Hodgkin’s Lymphomas and Other Cancers and Tu- 7.694 7.897 8.035 8.180 8.193 mors.

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TABLE 2—FINAL ADULT RISK ADJUSTMENT MODEL FACTORS FOR 2019 BENEFIT YEAR—Continued

HCC or RXC No. Factor Platinum Gold Silver Bronze Catastrophic

SEVERE x HCC115 ...... Severe illness x Myasthenia Gravis/Myoneural Disorders and Guillain- 7.694 7.897 8.035 8.180 8.193 Barre Syndrome/Inflammatory and Toxic Neuropathy. SEVERE x HCC135 ...... Severe illness x Heart Infection/Inflammation, Except Rheumatic ...... 7.694 7.897 8.035 8.180 8.193 SEVERE x HCC145 ...... Severe illness x Intracranial Hemorrhage ...... 7.694 7.897 8.035 8.180 8.193 SEVERE x G06 ...... Severe illness x HCC group G06 (G06 is HCC Group 6 which includes 7.694 7.897 8.035 8.180 8.193 the following HCCs in the blood disease category: 67, 68). SEVERE x G08 ...... Severe illness x HCC group G08 (G08 is HCC Group 8 which includes 7.694 7.897 8.035 8.180 8.193 the following HCCs in the blood disease category: 73, 74). SEVERE x HCC035 ...... Severe illness x End-Stage Liver Disease ...... 1.449 1.541 1.596 1.722 1.733 SEVERE x HCC038 ...... Severe illness x Acute Liver Failure/Disease, Including Neonatal Hepatitis 1.449 1.541 1.596 1.722 1.733 SEVERE x HCC153 ...... Severe illness x Atherosclerosis of the Extremities with Ulceration or 1.449 1.541 1.596 1.722 1.733 Gangrene. SEVERE x HCC154 ...... Severe illness x Vascular Disease with Complications ...... 1.449 1.541 1.596 1.722 1.733 SEVERE x HCC163 ...... Severe illness x Aspiration and Specified Bacterial Pneumonias and 1.449 1.541 1.596 1.722 1.733 Other Severe Lung Infections. SEVERE x HCC253 ...... Severe illness x Artificial Openings for Feeding or Elimination ...... 1.449 1.541 1.596 1.722 1.733 SEVERE x G03 ...... Severe illness x HCC group G03 (G03 is HCC Group 3 which includes 1.449 1.541 1.596 1.722 1.733 the following HCCs in the musculoskeletal disease category: 54, 55).

Enrollment Duration Factors

1 month of enrollment ...... 0.417 0.365 0.325 0.306 0.305 2 months of enrollment ...... 0.382 0.333 0.293 0.275 0.273 3 months of enrollment ...... 0.327 0.282 0.244 0.227 0.225 4 months of enrollment ...... 0.279 0.240 0.206 0.189 0.188 5 months of enrollment ...... 0.249 0.216 0.185 0.169 0.168 6 months of enrollment ...... 0.207 0.181 0.153 0.138 0.137 7 months of enrollment ...... 0.189 0.165 0.141 0.126 0.125 8 months of enrollment ...... 0.137 0.120 0.102 0.091 0.091 9 months of enrollment ...... 0.097 0.085 0.074 0.067 0.067 10 months of enrollment ...... 0.070 0.065 0.060 0.057 0.057 11 months of enrollment ...... 0.064 0.060 0.057 0.055 0.055

Prescription Drug Factors

RXC 01 ...... Anti-HIV Agents ...... 7.822 7.257 6.830 6.605 6.580 RXC 02 ...... Anti-Hepatitis C (HCV) Agents ...... 39.880 39.337 38.905 39.062 39.075 RXC 03 ...... Antiarrhythmics ...... 0.113 0.113 0.113 0.113 0.113 RXC 04 ...... Phosphate Binders ...... 0.730 0.730 0.730 0.730 0.730 RXC 05 ...... Inflammatory Bowel Disease Agents ...... 2.022 1.842 1.701 1.509 1.487 RXC 06 ...... Insulin ...... 1.498 1.349 1.185 0.993 0.973 RXC 07 ...... Anti-Diabetic Agents, Except Insulin and Metformin Only ...... 0.495 0.430 0.361 0.272 0.264 RXC 08 ...... Multiple Sclerosis Agents ...... 21.141 20.350 19.757 19.731 19.721 RXC 09 ...... Immune Suppressants and Immunomodulators ...... 13.273 12.681 12.240 12.270 12.268 RXC 10 ...... Cystic Fibrosis Agents ...... 13.045 12.712 12.485 12.565 12.574 RXC 01 x HCC001 ...... Additional effect for enrollees with RXC 01 (Anti-HIV Agents) and HCC 2.459 2.560 2.655 3.010 3.046 001 (HIV/AIDS). RXC 02 x HCC037_1, Additional effect for enrollees with RXC 02 (Anti-Hepatitis C (HCV) 2.645 2.838 2.974 3.020 3.025 036, 035, 034. Agents) and (HCC 037_1 (Chronic Viral Hepatitis C) or 036 (Cirrhosis of Liver) or 035 (End-Stage Liver Disease) or 034 (Liver Transplant Status/Complications)). RXC 03 x HCC142 ...... Additional effect for enrollees with RxC 03 (Antiarrhythmics) and HCC 0.000 0.000 0.000 0.000 0.000 142 (Specified Heart Arrhythmias). RXC 04 x HCC184, 183, Additional effect for enrollees with RxC 04 (Phosphate Binders) and 0.000 0.000 0.000 0.000 0.000 187, 188. (HCC 184 (End Stage Renal Disease) or 183 (Kidney Transplant Sta- tus) or 187 (Chronic Kidney Disease, Stage 5) or 188 (Chronic Kidney Disease, Severe Stage 4)). RXC 05 x HCC048, 041 Additional effect for enrollees with RxC 05 (Inflammatory Bowel Disease ¥1.192 ¥1.096 ¥0.997 ¥0.888 ¥0.878 Agents) and (HCC 048 (Inflammatory Bowel Disease) or 041 (Intestine Transplant Status/Complications)). RXC 06 x HCC018, 019, Additional effect for enrollees with RxC 06 (Insulin) and (HCC 018 (Pan- 0.421 0.395 0.456 0.533 0.538 020, 021. creas Transplant Status/Complications) or 019 (Diabetes with Acute Complications) or 020 (Diabetes with Chronic Complications) or 021 (Diabetes without Complication)). RXC 07 x HCC018, 019, Additional effect for enrollees with RxC 07 (Anti-Diabetic Agents, Except ¥0.202 ¥0.184 ¥0.153 ¥0.153 ¥0.155 020, 021. Insulin and Metformin Only) and (HCC 018 (Pancreas Transplant Sta- tus/Complications) or 019 (Diabetes with Acute Complications) or 020 (Diabetes with Chronic Complications) or 021 (Diabetes without Com- plication)). RXC 08 x HCC118 ...... Additional effect for enrollees with RxC 08 (Multiple Sclerosis Agents) ¥5.507 ¥4.981 ¥4.597 ¥4.422 ¥4.399 and HCC 118 (Multiple Sclerosis). RXC 09 x HCC056 or Additional effect for enrollees with RxC 09 (Immune Suppressants and ¥0.337 ¥0.352 ¥0.336 ¥0.370 ¥0.375 057 and 048 or 041. Immunomodulators) and (HCC 048 (Inflammatory Bowel Disease) or 041 (Intestine Transplant Status/Complications)) and (HCC 056 (Rheu- matoid Arthritis and Specified Autoimmune Disorders) or 057 (Systemic Lupus Erythematosus and Other Autoimmune Disorders)). RXC 09 x HCC056 ...... Additional effect for enrollees with RxC 09 (Immune Suppressants and ¥2.862 ¥2.632 ¥2.452 ¥2.323 ¥2.307 Immunomodulators) and HCC 056 (Rheumatoid Arthritis and Specified Autoimmune Disorders). RXC 09 x HCC057 ...... Additional effect for enrollees with RxC 09 (Immune Suppressants and ¥0.595 ¥0.444 ¥0.322 ¥0.175 ¥0.161 Immunomodulators) and HCC 057 (Systemic Lupus Erythematosus and Other Autoimmune Disorders).

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TABLE 2—FINAL ADULT RISK ADJUSTMENT MODEL FACTORS FOR 2019 BENEFIT YEAR—Continued

HCC or RXC No. Factor Platinum Gold Silver Bronze Catastrophic

RXC 09 x HCC048, 041 Additional effect for enrollees with RxC 09 (Immune Suppressants and 1.128 1.392 1.563 1.764 1.788 Immunomodulators) and (HCC 048 (Inflammatory Bowel Disease) or 041 (Intestine Transplant Status/Complications)). RXC 10 x HCC159, 158 Additional effect for enrollees with RxC 10 (Cystic Fibrosis Agents) and 29.170 29.398 29.528 29.588 29.594 (HCC 159 (Cystic Fibrosis) or 158 (Lung Transplant Status/Complica- tions)).

TABLE 3—HHS HCCSINTHESEVERITY ILLNESS INDICATOR VARIABLE

Description

Septicemia, Sepsis, Systemic Inflammatory Response Syndrome/Shock. Peritonitis/Gastrointestinal Perforation/Necrotizing Enter colitis. Seizure Disorders and Convulsions. Non-Traumatic Coma, Brain Compression/Anoxic Damage. Respirator Dependence/Tracheostomy Status. Respiratory Arrest. Cardio-Respiratory Failure and Shock, Including Respiratory Distress Syndromes. Pulmonary Embolism and Deep Vein Thrombosis.

TABLE 4—FINAL CHILD RISK ADJUSTMENT MODEL FACTORS FOR 2019 BENEFIT YEAR

Factor Platinum Gold Silver Bronze Catastrophic

Demographic Factors

Age 2–4, Male ...... 0.200 0.149 0.092 0.042 0.038 Age 5–9, Male ...... 0.138 0.100 0.055 0.018 0.015 Age 10–14, Male...... 0.193 0.152 0.100 0.060 0.058 Age 15–20, Male...... 0.258 0.209 0.151 0.099 0.095 Age 2–4, Female...... 0.153 0.109 0.062 0.025 0.022 Age 5–9, Female...... 0.102 0.068 0.031 0.005 0.003 Age 10–14, Female...... 0.182 0.142 0.095 0.059 0.056 Age 15–20, Female...... 0.281 0.224 0.155 0.091 0.086

Diagnosis Factors

HIV/AIDS ...... 5.368 4.942 4.622 4.506 4.493 Septicemia, Sepsis, Systemic Inflammatory Response Syndrome/Shock ...... 13.803 13.633 13.522 13.529 13.530 Central Nervous System Infections, Except Viral Menin- gitis ...... 8.179 8.020 7.905 7.913 7.913 Viral or Unspecified Meningitis ...... 3.563 3.358 3.225 3.077 3.063 Opportunistic Infections ...... 16.934 16.887 16.848 16.832 16.829 Metastatic Cancer...... 32.479 32.270 32.092 32.101 32.102 Lung, Brain, and Other Severe Cancers, Including Pedi- atric Acute Lymphoid Leukemia ...... 10.021 9.785 9.590 9.509 9.501 Non-Hodgkin’s Lymphomas and Other Cancers and Tu- mors ...... 7.835 7.601 7.411 7.304 7.292 Colorectal, Breast (Age <50), Kidney, and Other Cancers 3.051 2.879 2.737 2.618 2.605 Breast (Age 50+) and Prostate Cancer, Benign/Uncertain Brain Tumors, and Other Cancers and Tumors ...... 3.051 2.879 2.737 2.618 2.605 Thyroid Cancer, Melanoma, Neurofibromatosis, and Other Cancers and Tumors...... 1.188 1.057 0.943 0.818 0.805 Pancreas Transplant Status/Complications ...... 22.337 22.078 21.875 21.901 21.904 Diabetes with Acute Complications ...... 2.550 2.234 2.032 1.749 1.721 Diabetes with Chronic Complications ...... 2.550 2.234 2.032 1.749 1.721 Diabetes without Complication ...... 2.550 2.234 2.032 1.749 1.721 Protein-Calorie Malnutrition ...... 12.783 12.694 12.618 12.658 12.661 Mucopolysaccharidosis ...... 7.948 7.723 7.536 7.494 7.489 Lipidoses and Glycogenosis...... 7.948 7.723 7.536 7.494 7.489 Congenital Metabolic Disorders, Not Elsewhere Classified 7.948 7.723 7.536 7.494 7.489 Amyloidosis, Porphyria, and Other Metabolic Disorders ..... 7.948 7.723 7.536 7.494 7.489 Adrenal, Pituitary, and Other Significant Endocrine Dis- orders ...... 7.948 7.723 7.536 7.494 7.489 Liver Transplant Status/Complications ...... 22.337 22.078 21.875 21.901 21.904 End-Stage Liver Disease ...... 11.834 11.685 11.584 11.580 11.579 Cirrhosis of Liver ...... 5.782 5.646 5.535 5.507 5.507 Chronic Viral Hepatitis C ...... 6.269 6.114 5.983 5.966 5.967 Chronic Hepatitis, Other/Unspecified...... 1.200 1.086 0.983 0.923 0.920 Acute Liver Failure/Disease, Including Neonatal Hepatitis 11.636 11.494 11.390 11.392 11.391

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TABLE 4—FINAL CHILD RISK ADJUSTMENT MODEL FACTORS FOR 2019 BENEFIT YEAR—Continued

Factor Platinum Gold Silver Bronze Catastrophic

Intestine Transplant Status/Complications ...... 22.337 22.078 21.875 21.901 21.904 Peritonitis/Gastrointestinal Perforation/Necrotizing Enterocolitis ...... 11.572 11.283 11.063 11.060 11.061 Intestinal Obstruction...... 4.506 4.310 4.154 4.057 4.049 Chronic Pancreatitis...... 10.521 10.314 10.163 10.167 10.167 Acute Pancreatitis/Other Pancreatic Disorders and Intes- tinal Malabsorption...... 2.265 2.148 2.046 1.948 1.938 Inflammatory Bowel Disease...... 7.055 6.685 6.402 6.291 6.279 Necrotizing Fasciitis...... 3.907 3.706 3.544 3.468 3.461 Bone/Joint/Muscle Infections/Necrosis...... 3.907 3.706 3.544 3.468 3.461 Rheumatoid Arthritis and Specified Autoimmune Disorders 4.282 4.052 3.856 3.762 3.754 Systemic Lupus Erythematosus and Other Autoimmune Disorders ...... 1.092 0.970 0.854 0.726 0.714 Osteogenesis Imperfecta and Other Osteodystrophies ...... 1.402 1.292 1.193 1.110 1.102 Congenital/Developmental Skeletal and Connective Tissue Disorders ...... 1.402 1.292 1.193 1.110 1.102 Cleft Lip/Cleft Palate...... 1.435 1.260 1.121 0.992 0.980 Hemophilia ...... 61.183 60.705 60.325 60.299 60.296 Myelodysplastic Syndromes and Myelofibrosis ...... 14.718 14.596 14.505 14.474 14.470 Aplastic Anemia ...... 14.718 14.596 14.505 14.474 14.470 Acquired Hemolytic Anemia, Including Hemolytic Disease of Newborn...... 6.928 6.714 6.544 6.456 6.448 Sickle Cell Anemia (Hb–SS) ...... 6.928 6.714 6.544 6.456 6.448 Thalassemia Major...... 6.928 6.714 6.544 6.456 6.448 Combined and Other Severe Immunodeficiencies ...... 5.849 5.705 5.592 5.531 5.526 Disorders of the Immune Mechanism ...... 5.849 5.705 5.592 5.531 5.526 Coagulation Defects and Other Specified Hematological Disorders ...... 4.662 4.542 4.439 4.366 4.359 Drug Psychosis...... 5.648 5.392 5.211 5.131 5.125 Drug Dependence...... 5.648 5.392 5.211 5.131 5.125 Schizophrenia ...... 4.819 4.473 4.217 4.086 4.073 Major Depressive and Bipolar Disorders ...... 2.214 2.007 1.833 1.653 1.636 Reactive and Unspecified Psychosis, Delusional Disorders 2.129 1.931 1.762 1.584 1.567 Personality Disorders...... 0.622 0.517 0.405 0.257 0.243 Anorexia/Bulimia Nervosa...... 2.657 2.471 2.318 2.238 2.228 Prader-Willi, Patau, Edwards, and Autosomal Deletion Syndromes ...... 2.119 1.961 1.850 1.796 1.790 Down Syndrome, Fragile X, Other Chromosomal Anoma- lies, and Congenital Malformation Syndromes ...... 1.785 1.639 1.526 1.435 1.427 Autistic Disorder...... 2.017 1.836 1.677 1.511 1.495 Pervasive Developmental Disorders, Except Autistic Dis- order ...... 0.686 0.592 0.484 0.349 0.338 Traumatic Complete Lesion Cervical Spinal Cord ...... 11.525 11.463 11.427 11.507 11.514 Quadriplegia ...... 11.525 11.463 11.427 11.507 11.514 Traumatic Complete Lesion Dorsal Spinal Cord ...... 9.265 9.094 8.948 8.933 8.928 Paraplegia ...... 9.265 9.094 8.948 8.933 8.928 Spinal Cord Disorders/Injuries ...... 3.678 3.487 3.339 3.247 3.239 Amyotrophic Lateral Sclerosis and Other Anterior Horn Cell Disease...... 4.952 4.754 4.592 4.506 4.499 Quadriplegic Cerebral Palsy ...... 2.968 2.768 2.638 2.642 2.642 Cerebral Palsy, Except Quadriplegic ...... 0.496 0.392 0.322 0.263 0.261 Spina Bifida and Other Brain/Spinal/Nervous System Con- genital Anomalies...... 1.422 1.303 1.209 1.137 1.130 Myasthenia Gravis/Myoneural Disorders and Guillain-Barre Syndrome/Inflammatory and Toxic Neuropathy ...... 9.749 9.588 9.461 9.440 9.440 Muscular Dystrophy...... 2.584 2.410 2.280 2.179 2.168 Multiple Sclerosis ...... 10.447 10.104 9.835 9.801 9.797 Parkinson’s, Huntington’s, and Spinocerebellar Disease, and Other Neurodegenerative Disorders ...... 2.584 2.410 2.280 2.179 2.168 Seizure Disorders and Convulsions ...... 2.004 1.852 1.714 1.567 1.553 Hydrocephalus ...... 4.256 4.146 4.063 4.044 4.042 Non-Traumatic Coma, and Brain Compression/Anoxic Damage ...... 5.714 5.590 5.487 5.444 5.440 Respirator Dependence/Tracheostomy Status ...... 31.959 31.852 31.774 31.912 31.924 Respiratory Arrest...... 9.776 9.552 9.401 9.366 9.360 Cardio-Respiratory Failure and Shock, Including Res- piratory Distress Syndromes...... 9.776 9.552 9.401 9.366 9.360 Heart Assistive Device/Artificial Heart ...... 22.337 22.078 21.875 21.901 21.904 Heart Transplant...... 22.337 22.078 21.875 21.901 21.904 Congestive Heart Failure ...... 5.773 5.674 5.588 5.545 5.540 Acute Myocardial Infarction...... 5.179 5.104 5.062 5.048 5.046 Unstable Angina and Other Acute Ischemic Heart Disease 3.842 3.765 3.707 3.676 3.675

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TABLE 4—FINAL CHILD RISK ADJUSTMENT MODEL FACTORS FOR 2019 BENEFIT YEAR—Continued

Factor Platinum Gold Silver Bronze Catastrophic

Heart Infection/Inflammation, Except Rheumatic ...... 11.892 11.786 11.703 11.684 11.683 Hypoplastic Left Heart Syndrome and Other Severe Con- genital Heart Disorders ...... 4.742 4.584 4.427 4.311 4.301 Major Congenital Heart/Circulatory Disorders ...... 1.345 1.248 1.130 1.012 1.002 Atrial and Ventricular Septal Defects, Patent Ductus Arteriosus, and Other Congenital Heart/Circulatory Dis- orders ...... 0.876 0.787 0.684 0.591 0.584 Specified Heart Arrhythmias ...... 3.734 3.576 3.438 3.360 3.353 Intracranial Hemorrhage...... 12.674 12.462 12.308 12.302 12.303 Ischemic or Unspecified Stroke ...... 5.445 5.367 5.318 5.328 5.331 Cerebral Aneurysm and Arteriovenous Malformation ...... 3.374 3.188 3.056 2.980 2.972 Hemiplegia/Hemiparesis ...... 4.146 4.041 3.967 3.933 3.927 Monoplegia, Other Paralytic Syndromes ...... 3.501 3.373 3.284 3.255 3.254 Atherosclerosis of the Extremities with Ulceration or Gan- grene ...... 11.717 11.481 11.305 11.230 11.223 Vascular Disease with Complications ...... 14.161 14.049 13.958 13.980 13.981 Pulmonary Embolism and Deep Vein Thrombosis ...... 13.582 13.475 13.396 13.432 13.436 Lung Transplant Status/Complications ...... 22.337 22.078 21.875 21.901 21.904 Cystic Fibrosis...... 22.337 22.078 21.875 21.901 21.904 Chronic Obstructive Pulmonary Disease, Including Bronchiectasis ...... 0.375 0.310 0.225 0.134 0.126 Asthma ...... 0.375 0.310 0.225 0.134 0.126 Fibrosis of Lung and Other Lung Disorders ...... 3.073 2.971 2.872 2.801 2.795 Aspiration and Specified Bacterial Pneumonias and Other Severe Lung Infections ...... 8.178 8.122 8.074 8.105 8.108 Kidney Transplant Status ...... 12.436 12.166 11.969 11.943 11.938 End Stage Renal Disease ...... 36.073 35.963 35.872 35.976 35.985 Chronic Kidney Disease, Stage 5 ...... 4.148 4.017 3.909 3.812 3.806 Chronic Kidney Disease, Severe (Stage 4) ...... 4.148 4.017 3.909 3.812 3.806 Ectopic and Molar Pregnancy, Except with Renal Failure, Shock, or Embolism ...... 1.061 0.906 0.761 0.532 0.507 Miscarriage with Complications...... 1.061 0.906 0.761 0.532 0.507 Miscarriage with No or Minor Complications ...... 1.061 0.906 0.761 0.532 0.507 Completed Pregnancy With Major Complications ...... 2.897 2.512 2.294 1.986 1.950 Completed Pregnancy With Complications ...... 2.897 2.512 2.294 1.986 1.950 Completed Pregnancy with No or Minor Complications ...... 2.897 2.512 2.294 1.986 1.950 Chronic Ulcer of Skin, Except Pressure ...... 2.338 2.247 2.159 2.086 2.079 Hip Fractures and Pathological Vertebral or Humerus Fractures ...... 5.437 5.163 4.942 4.830 4.822 Pathological Fractures, Except of Vertebrae, Hip, or Hu- merus ...... 1.665 1.535 1.404 1.262 1.248 Stem Cell, Including Bone Marrow, Transplant Status/ Complications ...... 22.337 22.078 21.875 21.901 21.904 Artificial Openings for Feeding or Elimination ...... 11.371 11.258 11.185 11.294 11.305 Amputation Status, Lower Limb/Amputation Complications 6.737 6.497 6.322 6.207 6.195

TABLE 5—FINAL INFANT RISK ADJUSTMENT MODEL FACTORS FOR 2019 BENEFIT YEAR

Group Platinum Gold Silver Bronze Catastrophic

Extremely Immature * Severity Level 5 (Highest) ...... 253.927 252.583 251.467 251.462 251.464 Extremely Immature * Severity Level 4 ...... 154.510 153.094 151.930 151.820 151.808 Extremely Immature * Severity Level 3 ...... 33.920 32.887 32.017 31.768 31.749 Extremely Immature * Severity Level 2 ...... 33.920 32.887 32.017 31.768 31.749 Extremely Immature * Severity Level 1 (Lowest) ...... 33.920 32.887 32.017 31.768 31.749 Immature * Severity Level 5 (Highest) ...... 159.462 158.128 157.021 157.005 157.004 Immature * Severity Level 4 ...... 72.478 71.132 70.018 69.946 69.937 Immature * Severity Level 3 ...... 32.912 31.777 30.841 30.633 30.613 Immature * Severity Level 2 ...... 24.333 23.245 22.351 22.082 22.055 Immature * Severity Level 1 (Lowest) ...... 24.333 23.245 22.351 22.082 22.055 Premature/Multiples * Severity Level 5 (Highest) ...... 115.833 114.548 113.499 113.406 113.398 Premature/Multiples * Severity Level 4 ...... 27.460 26.234 25.253 25.043 25.026 Premature/Multiples * Severity Level 3 ...... 14.214 13.255 12.482 12.044 12.001 Premature/Multiples * Severity Level 2 ...... 7.992 7.259 6.638 6.009 5.940 Premature/Multiples * Severity Level 1 (Lowest) ...... 5.323 4.790 4.246 3.652 3.600 Term * Severity Level 5 (Highest) ...... 91.593 90.463 89.524 89.335 89.320 Term * Severity Level 4 ...... 14.962 14.042 13.315 12.830 12.788 Term * Severity Level 3 ...... 5.857 5.300 4.767 4.150 4.092 Term * Severity Level 2 ...... 3.574 3.148 2.666 1.994 1.935 Term * Severity Level 1 (Lowest) ...... 1.546 1.321 0.916 0.449 0.423 Age1 * Severity Level 5 (Highest) ...... 253.927 252.583 251.467 251.462 251.464

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TABLE 5—FINAL INFANT RISK ADJUSTMENT MODEL FACTORS FOR 2019 BENEFIT YEAR—Continued

Group Platinum Gold Silver Bronze Catastrophic

Age1 * Severity Level 4 ...... 154.510 153.094 151.930 151.820 151.808 Age1 * Severity Level 3 ...... 33.920 32.887 32.017 31.768 31.749 Age1 * Severity Level 2 ...... 33.920 32.887 32.017 31.768 31.749 Age1 * Severity Level 1 (Lowest) ...... 33.920 32.887 32.017 31.768 31.749 Age 0 Male ...... 159.462 158.128 157.021 157.005 157.004 Age 1 Male ...... 72.478 71.132 70.018 69.946 69.937

TABLE 6—HHS HCCS INCLUDED IN INFANT MODEL MATURITY CATEGORIES

Maturity category HCC/description

Extremely Immature ...... Extremely Immature Newborns, Birth weight <500 Grams. Extremely Immature ...... Extremely Immature Newborns, Including Birth weight 500–749 Grams. Extremely Immature ...... Extremely Immature Newborns, Including Birth weight 750–999 Grams. Immature ...... Premature Newborns, Including Birth weight 1,000–1,499 Grams. Immature ...... Premature Newborns, Including Birth weight 1,500–1,999 Grams. Premature/Multiples ...... Premature Newborns, Including Birth weight 2,000–2,499 Grams. Premature/Multiples ...... Other Premature, Low Birth weight, Malnourished, or Multiple Birth Newborns. Term ...... Term or Post-Term Singleton Newborn, Normal or High Birth weight. Age 1 ...... All age 1 infants.

TABLE 7—HHS HCCS INCLUDED IN INFANT MODEL SEVERITY CATEGORIES

Severity category HCC

Severity Level 5 (Highest) ...... Metastatic Cancer. Severity Level 5 ...... Pancreas Transplant Status/Complications. Severity Level 5 ...... Liver Transplant Status/Complications. Severity Level 5 ...... End-Stage Liver Disease. Severity Level 5 ...... Intestine Transplant Status/Complications. Severity Level 5 ...... Peritonitis/Gastrointestinal Perforation/Necrotizing Enterocolitis. Severity Level 5 ...... Respirator Dependence/Tracheostomy Status. Severity Level 5 ...... Heart Assistive Device/Artificial Heart. Severity Level 5 ...... Heart Transplant. Severity Level 5 ...... Congestive Heart Failure. Severity Level 5 ...... Hypoplastic Left Heart Syndrome and Other Severe Congenital Heart Disorders. Severity Level 5 ...... Lung Transplant Status/Complications. Severity Level 5 ...... Kidney Transplant Status. Severity Level 5 ...... End Stage Renal Disease. Severity Level 5 ...... Stem Cell, Including Bone Marrow, Transplant Status/Complications. Severity Level 4 ...... Septicemia, Sepsis, Systemic Inflammatory Response Syndrome/Shock. Severity Level 4 ...... Lung, Brain, and Other Severe Cancers, Including Pediatric Acute Lymphoid Leukemia. Severity Level 4 ...... Mucopolysaccharidosis. Severity Level 4 ...... Major Congenital Anomalies of Diaphragm, Abdominal Wall, and Esophagus, Age <2. Severity Level 4 ...... Myelodysplastic Syndromes and Myelofibrosis. Severity Level 4 ...... Aplastic Anemia. Severity Level 4 ...... Combined and Other Severe Immunodeficiencies. Severity Level 4 ...... Traumatic Complete Lesion Cervical Spinal Cord. Severity Level 4 ...... Quadriplegia. Severity Level 4 ...... Amyotrophic Lateral Sclerosis and Other Anterior Horn Cell Disease. Severity Level 4 ...... Quadriplegic Cerebral Palsy. Severity Level 4 ...... Myasthenia Gravis/Myoneural Disorders and Guillain-Barre Syndrome/Inflammatory and Toxic Neuropathy. Severity Level 4 ...... Non-Traumatic Coma, Brain Compression/Anoxic Damage. Severity Level 4 ...... Respiratory Arrest. Severity Level 4 ...... Cardio-Respiratory Failure and Shock, Including Respiratory Distress Syndromes. Severity Level 4 ...... Acute Myocardial Infarction. Severity Level 4 ...... Heart Infection/Inflammation, Except Rheumatic. Severity Level 4 ...... Major Congenital Heart/Circulatory Disorders. Severity Level 4 ...... Intracranial Hemorrhage. Severity Level 4 ...... Ischemic or Unspecified Stroke. Severity Level 4 ...... Vascular Disease with Complications. Severity Level 4 ...... Pulmonary Embolism and Deep Vein Thrombosis. Severity Level 4 ...... Aspiration and Specified Bacterial Pneumonias and Other Severe Lung Infections. Severity Level 4 ...... Chronic Kidney Disease, Stage 5. Severity Level 4 ...... Hip Fractures and Pathological Vertebral or Humerus Fractures. Severity Level 4 ...... Artificial Openings for Feeding or Elimination. Severity Level 3 ...... HIV/AIDS. Severity Level 3 ...... Central Nervous System Infections, Except Viral Meningitis.

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TABLE 7—HHS HCCS INCLUDED IN INFANT MODEL SEVERITY CATEGORIES—Continued

Severity category HCC

Severity Level 3 ...... Opportunistic Infections. Severity Level 3 ...... Non-Hodgkin’s Lymphomas and Other Cancers and Tumors. Severity Level 3 ...... Colorectal, Breast (Age <50), Kidney and Other Cancers. Severity Level 3 ...... Breast (Age 50+), Prostate Cancer, Benign/Uncertain Brain Tumors, and Other Cancers and Tumors. Severity Level 3 ...... Lipidoses and Glycogenosis. Severity Level 3 ...... Adrenal, Pituitary, and Other Significant Endocrine Disorders. Severity Level 3 ...... Acute Liver Failure/Disease, Including Neonatal Hepatitis. Severity Level 3 ...... Intestinal Obstruction. Severity Level 3 ...... Necrotizing Fasciitis. Severity Level 3 ...... Bone/Joint/Muscle Infections/Necrosis. Severity Level 3 ...... Osteogenesis Imperfecta and Other Osteodystrophies. Severity Level 3 ...... Cleft Lip/Cleft Palate. Severity Level 3 ...... Hemophilia. Severity Level 3 ...... Disorders of the Immune Mechanism. Severity Level 3 ...... Coagulation Defects and Other Specified Hematological Disorders. Severity Level 3 ...... Prader-Willi, Patau, Edwards, and Autosomal Deletion Syndromes. Severity Level 3 ...... Traumatic Complete Lesion Dorsal Spinal Cord. Severity Level 3 ...... Paraplegia. Severity Level 3 ...... Spinal Cord Disorders/Injuries. Severity Level 3 ...... Cerebral Palsy, Except Quadriplegic. Severity Level 3 ...... Muscular Dystrophy. Severity Level 3 ...... Parkinson’s, Huntington’s, and Spinocerebellar Disease, and Other Neurodegenerative Dis- orders. Severity Level 3 ...... Hydrocephalus. Severity Level 3 ...... Unstable Angina and Other Acute Ischemic Heart Disease. Severity Level 3 ...... Atrial and Ventricular Septal Defects, Patent Ductus Arteriosus, and Other Congenital Heart/ Circulatory Disorders. Severity Level 3 ...... Specified Heart Arrhythmias. Severity Level 3 ...... Cerebral Aneurysm and Arteriovenous Malformation. Severity Level 3 ...... Hemiplegia/Hemiparesis. Severity Level 3 ...... Cystic Fibrosis. Severity Level 3 ...... Fibrosis of Lung and Other Lung Disorders. Severity Level 3 ...... Pathological Fractures, Except of Vertebrae, Hip, or Humerus. Severity Level 2 ...... Viral or Unspecified Meningitis. Severity Level 2 ...... Thyroid, Melanoma, Neurofibromatosis, and Other Cancers and Tumors. Severity Level 2 ...... Diabetes with Acute Complications. Severity Level 2 ...... Diabetes with Chronic Complications. Severity Level 2 ...... Diabetes without Complication. Severity Level 2 ...... Protein-Calorie Malnutrition. Severity Level 2 ...... Congenital Metabolic Disorders, Not Elsewhere Classified. Severity Level 2 ...... Amyloidosis, Porphyria, and Other Metabolic Disorders. Severity Level 2 ...... Cirrhosis of Liver. Severity Level 2 ...... Chronic Pancreatitis. Severity Level 2 ...... Inflammatory Bowel Disease. Severity Level 2 ...... Rheumatoid Arthritis and Specified Autoimmune Disorders. Severity Level 2 ...... Systemic Lupus Erythematosus and Other Autoimmune Disorders. Severity Level 2 ...... Congenital/Developmental Skeletal and Connective Tissue Disorders. Severity Level 2 ...... Acquired Hemolytic Anemia, Including Hemolytic Disease of Newborn. Severity Level 2 ...... Sickle Cell Anemia (Hb–SS). Severity Level 2 ...... Drug Psychosis. Severity Level 2 ...... Drug Dependence. Severity Level 2 ...... Down Syndrome, Fragile X, Other Chromosomal Anomalies, and Congenital Malformation Syndromes. Severity Level 2 ...... Spina Bifida and Other Brain/Spinal/Nervous System Congenital Anomalies. Severity Level 2 ...... Seizure Disorders and Convulsions. Severity Level 2 ...... Monoplegia, Other Paralytic Syndromes. Severity Level 2 ...... Atherosclerosis of the Extremities with Ulceration or Gangrene. Severity Level 2 ...... Chronic Obstructive Pulmonary Disease, Including Bronchiectasis. Severity Level 2 ...... Chronic Ulcer of Skin, Except Pressure. Severity Level 1 (Lowest) ...... Chronic Hepatitis. Severity Level 1 ...... Acute Pancreatitis/Other Pancreatic Disorders and Intestinal Malabsorption. Severity Level 1 ...... Thalassemia Major. Severity Level 1 ...... Autistic Disorder. Severity Level 1 ...... Pervasive Developmental Disorders, Except Autistic Disorder. Severity Level 1 ...... Multiple Sclerosis. Severity Level 1 ...... Asthma. Severity Level 1 ...... Chronic Kidney Disease, Severe (Stage 4). Severity Level 1 ...... Amputation Status, Lower Limb/Amputation Complications. Severity Level 1 ...... No Severity HCCs.

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d. Cost-Sharing Reductions Adjustments drug utilization factors (for the adult and used by Massachusetts for the 2014, (§ 153.320) models). We are finalizing the cost- 2015 and 2016 benefit years. We proposed to continue including an sharing reductions adjustment factors as Response: We are finalizing the cost- adjustment for the receipt of cost- proposed. See Table 8 for the list of final sharing reductions adjustment induced sharing reductions in the model to cost-sharing reductions adjustments for demand factors as proposed. We account for increased plan liability due the 2019 benefit year. anticipate proposing adjustments to the to increased utilization of health care Comment: Commenters supported our cost-sharing reductions adjustment services by enrollees receiving cost- proposal to use the same cost-sharing induced demand factors in the annual sharing reductions (induced demand) in reductions adjustment induced demand HHS notice of benefit and payment all States where HHS operates risk factors as prior years, noting that the use parameters for the 2020 benefit year adjustment. The proposed cost-sharing of these factors would promote stability based on enrollee-level EDGE data. reductions adjustment factors for the and certainty in the markets, and Consistent with the approach outlined 2019 benefit year were unchanged from supported making updates in 2020 to in the final 2017 Payment Notice, we those finalized in the 2018 Payment the induced demand factors based on will continue to use cost-sharing Notice. These adjustments would be EDGE enrollee-level data. One reductions adjustment factors of 1.12 for effective for 2016, 2017, 2018, and 2019 commenter requested that HHS all Massachusetts wrap-around plans in risk adjustment, and would be maintain the induced demand factors of the risk adjustment transfers multiplied against the sum of the 1.12 for wrap-around, premium calculation, as all of Massachusetts’ demographic, diagnosis, and interaction assistance plans for Massachusetts, as cost-sharing plan variations have factors, and enrollment and prescription established in the 2014 Payment Notice actuarial values above 94 percent.

TABLE 8—COST-SHARING REDUCTIONS ADJUSTMENT

Induced Household income Plan AV utilization factor

Silver Plan Variant Recipients

100–150% of FPL ...... Plan Variation 94% ...... 1.12 150–200% of FPL ...... Plan Variation 87% ...... 1.12 200–250% of FPL ...... Plan Variation 73% ...... 1.00 >250% of FPL ...... Standard Plan 70% ...... 1.00

Zero Cost-Sharing Recipients

<300% of FPL ...... Platinum (90%) ...... 1.00 <300% of FPL ...... Gold (80%) ...... 1.07 <300% of FPL ...... Silver (70%) ...... 1.12 <300% of FPL ...... Bronze (60%) ...... 1.15

Limited Cost-Sharing Recipients

>300% of FPL ...... Platinum (90%) ...... 1.00 >300% of FPL ...... Gold (80%) ...... 1.07 >300% of FPL ...... Silver (70%) ...... 1.12 >300% of FPL ...... Bronze (60%) ...... 1.15

e. Model Performance Statistics subpopulations. The predictive ratio for squared statistic and the predictive (§ 153.320) each of the HHS risk adjustment models ratios are in the range of published is the ratio of the weighted mean estimates for concurrent risk adjustment To evaluate model performance, we predicted plan liability for the model models.17 Because we are blending the examined each model’s R-squared sample population to the weighted coefficients from separately solved statistic and predictive ratios. The R- mean actual plan liability for the model models based on 2014 and 2015 squared statistic, which calculates the sample population. The predictive ratio MarketScan® data and 2016 enrollee- percentage of individual variation represents how well the model does on level EDGE data, we are publishing the explained by a model, measures the average at predicting plan liability for R-squared statistic for each model and predictive accuracy of the model that subpopulation. A subpopulation benefit year separately to verify their overall. The predictive ratios measure that is predicted perfectly would have a statistical validity. The R-squared the predictive accuracy of a model for predictive ratio of 1.0. For each of the statistic for each model is shown in different validation groups or HHS risk adjustment models, the R- Table 9.

17 Winkleman, Ross and Syed Mehmud. ‘‘A Health Risk Assessment.’’ Society of Actuaries. Comparative Analysis of Claims-Based Tools for April 2007.

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TABLE 9—R-SQUARED STATISTIC FOR FINAL HHS RISK ADJUSTMENT MODELS

R-squared statistic 2016 Risk adjustment model 2014 2015 ® ® Enroll-level MarketScan MarketScan EDGE

Platinum Adult ...... 0.4221 0.4212 0.4283 Platinum Child ...... 0.293 0.3314 0.3099 Platinum Infant ...... 0.3284 0.3329 0.3239 Gold Adult ...... 0.4179 0.4164 0.4228 Gold Child ...... 0.2883 0.3269 0.3053 Gold Infant ...... 0.3264 0.3309 0.3201 Silver Adult ...... 0.4143 0.4123 0.4181 Silver Child ...... 0.2841 0.3227 0.3013 Silver Infant ...... 0.325 0.3295 0.317 Bronze Adult ...... 0.4117 0.4095 0.4152 Bronze Child ...... 0.2805 0.3188 0.2978 Bronze Infant ...... 0.3247 0.3292 0.3154 Catastrophic Adult ...... 0.4115 0.4094 0.4145 Catastrophic Child ...... 0.2803 0.3186 0.2971 Catastrophic Infant ...... 0.3247 0.3292 0.3151

f. Overview of the Payment Transfer transfers for the entire market sum to needed to assess a charge, or otherwise Formula (§ 153.320) zero. collect additional funds, or prorate In the absence of additional funding, i. Accounting for High-Cost Risk Pool in payments based on the charges collected we established, through notice and the Transfer Formula to balance the risk adjustment transfers. comment rulemaking,18 risk adjustment This uncertainty would conflict with We previously defined the calculation as a budget neutral program in order to the overall goals of the risk adjustment of plan average actuarial risk and the provide certainty to issuers regarding program: to stabilize premiums and calculation of payments and charges in risk adjustment payments and allow reduce incentives for issuers to avoid the Premium Stabilization Rule. In the them to set rates based on those enrolling individuals with higher than 2014 Payment Notice, we combined expectations. Adopting an approach that average actuarial risk. those concepts into a risk adjustment would not result in balanced payments The State payment transfer formula in payment transfer formula. Risk and charges would create considerable adjustment transfers (total payments the HHS risk adjustment methodology is uncertainty for issuers regarding the designed to provide a per member per and charges including high-cost risk proportion of risk adjustment payments pool payments and charges) will be month (PMPM) transfer amount. The they could expect to receive from the PMPM transfer amount derived from the calculated after issuers have completed Federal government. Additionally, in risk adjustment data reporting. The State payment transfer formula would establishing the HHS-operated risk be multiplied by each plan’s total payment transfer formula includes a set adjustment program, HHS could not of cost adjustment terms that require billable member months for the benefit have relied on the potential availability year to determine the total payment due transfers to be calculated at the of general appropriation funds without geographic rating area level for each to or charge owed by the issuer for that creating uncertainty for issuers in the plan in a rating area. The total payment plan (that is, HHS will calculate amount of risk adjustment payments separate transfer amounts for each rating or charge is thus calculated to balance they could expect, or reducing funding the State market risk pool in question. area in which a plan operates). available for other programs. Relying on In addition to the total charge or The risk adjustment transfer formula each year’s budget would have required payment assessed for an issuer in a State generally calculates the difference HHS to delay setting the parameters for market risk pool based on plan liability between the revenues required by a any risk adjustment payment proration risk scores, in the 2018 Payment Notice, plan, based on the health risk of the rates well after the plans were in effect we added to the risk adjustment plan’s enrollees, and the revenues that for the applicable benefit year. HHS also methodology additional transfers that a plan can generate for those enrollees. would not have been able to rely on any would reflect the payments and charges These differences are compared across potential State budget appropriations for assessed with respect to the high-cost plans in the State market risk pool and States that elected to operate a State- risk pool. To account for costs converted to a dollar amount based on based risk adjustment program as such associated with exceptionally high-risk the Statewide average premium. Thus, funds would not have been available for enrollees, we added transfer terms (a each plan in the risk pool receives a risk purposes of administering the HHS- payment term and a charge term) that adjustment payment or charge designed operated risk adjustment program. would be calculated separately from the to compensate for risk for a plan with Without the adoption of a budget State transfer formula in the HHS risk average efficiency. Scaling the risk neutral framework, HHS would have adjustment transfers by the Statewide adjustment methodology. Beginning for average premium, as opposed to, for 18 See, for example, Standards Related to the 2018 benefit year, we added one example, the plan’s own premium, Reinsurance, Risk Corridors and Risk Adjustment. term that reflects 60 percent of costs minimizes issuers’ ability to manipulate Proposed Rule, 76 FR 41938 (July 15, 2011); above $1 million (HRPi, in the total plan their transfers by adjusting their own Standards Related to Reinsurance, Risk Corridors transfer calculation described below), and Risk Adjustment. Final Rule, 77 FR 17232 plan premiums, and results in a (March 23, 2012); and HHS Notice of Benefit and and another term that reflects a percent calculation of equal payments and Payment Parameters for 2014. Final Rule, 78 FR of premium adjustment to fund the charges, ensuring that risk adjustment 15441 (March 11, 2013). high-cost risk pool and maintain the

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balance of payment and charges within with claims for the 2019 benefit year administrative cost percentage that does the risk adjustment program. The and future benefit years until changed not vary with claims is 14 percent. We percent of premium adjustment factor in rulemaking. As a note, we have continue to believe that this percentage applied to a plan’s total premium previously defined the cost scaling represents the mean administrative cost amounts results in the same adjustment factor, or the Statewide average percentage that does not vary with as a percent of PMPM premium premium term, as the sum of average claims in the individual and small adjustment factor applied to a plan’s premium per member month of plan (Pi) group markets, and represents a PMPM premium amount and multiplied multiplied by plan i’s share of Statewide reasonable percentage of administrative by the plan’s number of billable member enrollment in the market in the risk costs on which risk adjustment transfers months. For this calculation, we will pool (si). For the 2019 benefit year, the should not be calculated. Based on this use a percent of premium adjustment Statewide average premium, which will analysis, we are finalizing the policy as factor that is applied to each plan’s total also be used for the transfer calculation proposed to reduce the Statewide premium amounts, rather than the for the 2018 benefit year, will be average premium factor of the risk percent of PMPM premium adjustment adjusted to remove a portion of the adjustment formula by 14 percent. factor described in 2018 Payment Notice administrative costs as follows: Allowing the factor to vary with claims and the proposed rule, for simplicity; P¯ S = (Si(si · Pi)) * 0.86 experience could lead to gaming and and, as detailed above, we note that the risk selection, as issuers with lower risk Where: mathematical outcome is the same. The would receive lower charges if their percent of premium adjustment factor si = plan i’s share of Statewide enrollment in administrative costs are relatively the market in the risk pool; (HRPCm) is determined based on the higher. Therefore, we will continue to Pi = average premium per member month of sum of payments for the high-cost risk plan i. reduce the Statewide average premium pool enrollees divided by the sum of factor of the risk adjustment formula by We are finalizing the policy to reduce premiums in the respective high-cost the same percentage for all issuers. risk pool market (m), nationally—one the Statewide average premium in the for the individual market, including risk adjustment formula by 14 percent, iii. State Flexibility catastrophic, non-catastrophic and as proposed, for the 2019 benefit year The HHS risk adjustment payment merged market plans, and another for and future benefit years until changed transfer formula generally transfers the small group market. The percent of in rulemaking. amounts from issuers with lower than premium adjustment factor is Comment: Most commenters average actuarial risk to those with multiplied by the plan’s total premium supported our proposal to continue to higher than average actuarial risk. Risk remove a portion of the administrative (HRPCm · Pi). adjustment is widely used in health For the 2019 benefit year, we are costs from the Statewide average insurance markets, and is recognized as finalizing the proposed policy to premium factor of the risk adjustment a critical measure in mitigating the maintain this adjustment to the risk transfer formula. Other commenters effects of adverse selection, ensuring adjustment transfers with the threshold requested HHS publish the methodology financial viability of plans that enroll a of $1 million and a coinsurance rate of used to create the 14 percent reduction higher proportion of high-risk enrollees, 60 percent, as finalized for the 2018 from the MLR data. One commenter and fostering competitive health benefit year. suggested HHS increase the reduction to insurance markets. The State transfer Comment: In addition to the 16 percent and another commenter formula in the HHS-operated risk comments discussed above, one requested HHS set the 14 percent adjustment program is scaled with the commenter requested that the high-cost reduction as the floor. Another Statewide average premium in the risk pool adjustment factors be included commenter suggested HHS should set applicable State market. In the 2018 in the risk adjustment formula. the factor closer to the market average Payment Notice, we noted that Response: We have included a of administrative costs, or allow the compared to other scaling factors, such calculation for the total plan transfer level to vary with issuers’ claims as plans’ own premiums, our analyses amount below to illustrate the inclusion experience. found that the Statewide average of the high-cost risk pool adjustment Response: As we noted in the 2018 premium proves to be a more terms in the HHS risk adjustment Payment Notice, we analyzed appropriate means of scaling the methodology. As noted above, these administrative and other non-claims transfers for differences in relative terms will be applied within the high- expenses, including quality actuarial risk, particularly in the context cost risk pool markets nationally—one improvement expenses, taxes and fees, of a budget-neutral system. As noted in for the individual market, including and non-claims costs, in the MLR the above section, beginning with the catastrophic, non-catastrophic and Annual Reporting Form, and estimated, 2018 benefit year, we also adopted an merged market plans, and another for by category, the extent to which the administrative cost adjustment to the the small group market. We are expenses varied with claims. We Statewide average premium to remove a finalizing the high-cost risk pool compared those expenses to the total portion of administrative costs that did adjustment parameters for the 2019 costs that issuers finance through not vary based on claims differences benefit year as proposed. premiums, including claims, from the Statewide average premium administrative expenses, and taxes, and base the transfers on the portion of ii. Administrative Cost Reduction to netting out claims costs financed the premiums that vary with claims.19 Statewide Average Premium through cost-sharing reductions We continue to believe the Statewide Additionally, we proposed to payments. We compared these expenses average premium, as adjusted, is a continue the policy finalized in the to total costs, rather than directly to reasonable metric to measure the costs 2018 Payment Notice to reduce the premiums, to ensure that the estimated of adverse selection. Based on our Statewide average premium, the cost administrative cost percentage was not experience operating the risk scaling factor in the risk adjustment distorted by under- or over-pricing transfer formula, by 14 percent to during the years for which MLR data are 19 81 FR 94099, 94100. (December 22, 2016). account for the proportion of available. Using this methodology, we Available at https://www.gpo.gov/fdsys/pkg/FR- administrative costs that do not vary determined that the mean 2016-12-22/pdf/2016-30433.pdf.

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adjustment program, HHS has become their own State risk adjustment program this proposal for the small group aware that certain issuers, including under a Federally certified alternate risk market, including the size of the some new, rapidly growing, or smaller adjustment methodology and are free to reduction, the timing of the request issuers, owed substantial risk exercise that authority to develop a risk submission, what evidence States adjustment charges that they did not adjustment program tailored to the should be required to provide, and what anticipate. HHS has had a number of markets in their State. However, we also procedural requirements should be discussions with issuers and State believe that allowing certain State- established. regulators on ways to encourage new specific adjustments to the HHS risk We also sought comment on whether participation in the health insurance adjustment methodology can account we should establish a similar process markets and mitigate the effects of for the effect of State-specific rules through which States could request a substantial risk adjustment charge without the necessity for States to reduction to the calculation of risk amounts. We believe that a robust risk undertake operation of their own risk adjustment transfers in the individual adjustment program that addresses adjustment program. market. Although adverse selection in concerns of risk selection is critical to In the case of small group markets, the individual market is not mitigated the proper functioning of health where States can demonstrate that the by group enrollment or minimum insurance markets. However, we differential risk profiles observed in the participation requirements as is the recognize that States are the primary small group market plans in that State selection in the small group market, we regulators of their insurance markets. In are attributable to factors other than recognized that a State may believe the the May 2016 Interim Final Rule,20 HHS systematic risk selection, and adverse HHS risk adjustment methodology, recognized some State regulators’ belief selection risk is mitigated by the small which is calibrated on a national that reducing the magnitude of risk group market dynamics, such as those dataset, may not precisely account for adjustment charge amounts could be described above, we proposed to permit relative actuarial risk differences in its beneficial to the insurance markets in States’ primary insurance regulators to individual market risk pool. We sought their States. For some States, an request a percentage reduction in the comment on whether, if a State can adjustment to risk adjustment transfers calculation of the risk adjustment demonstrate such a difference in calculated under the HHS-operated risk transfer amounts in the small group calculated relative actuarial risk, we adjustment program might more market in their State, beginning for the should reduce States’ administrative precisely account for cost differences 2019 benefit year. burden in operating its own risk attributable to adverse selection in the We proposed that HHS would require adjustment program by allowing some respective State market risk pools. We any State that seeks this flexibility to flexibility in the HHS risk adjustment encouraged States to examine whether submit its proposal for an adjustment to methodology to the extent permissible any local approaches under State legal the Statewide average premium in the under the statute. Therefore, we sought authority are warranted to help ease the small group market within 30 calendar comment on what individual market transition for new entrants to the health days after publication of the proposed features would justify such a reduction, insurance markets and mitigate the HHS notice of benefit and payment and what additional submissions a State effects of large risk adjustment charge parameters for the applicable benefit should provide in order to justify such amounts. In the small group market, year, in order to permit issuers to a departure for that market. employers select the plans offered to incorporate any such adjustment into We recognize that it is possible the their employees and often pay a their proposed rates. In order to promote HHS risk adjustment methodology, significant portion of employees’ transparency and solicit feedback from which is calibrated on a national dataset premiums to encourage enrollment. consumers and stakeholders on the and does not take into account State- Depending on the participation rules proposed reductions to the HHS risk specific rules or market dynamics, may and market dynamics within a adjustment transfer formula, we not precisely account for relative particular State, risk selection can be proposed HHS would publish the actuarial risk differences in certain significantly less in a State’s small requested State reduction percentages States’ individual, small group or group market compared to its individual for public comment in guidance while merged markets, and those State- market. The HHS methodology it begins its initial review of the State specific rules or other relevant factors calculates relative risk scores between requests. We proposed that HHS would could support a reduction to transfers in issuers in a State market, and in the case then make final determinations on State that State’s individual, small group or of the small group market, the requests by March 1 of the benefit year merged market. To accommodate differences between risk scores for prior to the applicable benefit year, in situations where there may be such issuers within State markets are time for issuers’ initial rate setting differences in State factors compared to generally smaller, leading to a smaller deadline. The proposed timing of the the national norm, HHS is finalizing the magnitude of risk adjustment transfers State adjustment request, publication of policy to provide States the flexibility to in the small group market as compared HHS guidance setting forth the request a reduction to the otherwise to the individual market. Certain States requested State reduction percentages, applicable risk adjustment transfers in have opined that the HHS risk public notice and comment period and the individual, small group or merged adjustment methodology, which is HHS approval process would permit market by up to 50 percent with some calibrated on a national dataset and plans to incorporate approved modifications, outlined below, in does not take into account the effect of adjustments in their rates for the response to comments. In States that State-specific laws and rating rules, in applicable benefit year. request a reduction to transfers, the Under the proposal, HHS would some circumstances may not precisely reduction percentage up to 50 percent, consider requests from State regulators account for risk differences for their if approved by HHS, would be applied to reduce the calculation of the particular State. We note that States to the plan PMPM payment or charge Statewide average premium used in the have the statutory authority to operate transfer amount (Ti in the State transfer HHS risk adjustment transfer formula in formula below), beginning with the 20 91 FR 29146, 29152. (May 11, 2016). Available the small group market by up to 50 2020 benefit year. We are amending at https://www.gpo.gov/fdsys/pkg/FR-2016-05-11/ percent for the applicable benefit year. § 153.320 to add a new paragraph (d) to pdf/2016-11017.pdf. We sought comment on all aspects of capture this State flexibility to request

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reduction to transfers in the individual, the reduction to transfers would have a paragraph (d)(3), we will publish the small group or merged market. States de minimis impact as described above. 2020 and future benefit year requests in requesting such reductions must submit As reflected in paragraph (d)(4)(ii) to the respective benefit year’s proposed evidence and analysis to HHS § 153.320, HHS may approve a HHS notice of benefit and payment identifying the State-specific rules or reduction amount lower than that parameters and make the supporting market dynamics that warrant an requested by the State if the supporting evidence available to the public in order adjustment and demonstrating the evidence and analysis do not fully to seek public comment, and will actuarial risk differences in plans in the support the percentage reduction publish any approved State reduction applicable State market are attributable requested. In response to commenters’ requests or denied State reduction to factors other than systematic risk concerns about market impacts on requests in the respective benefit year’s selection, as well as substantiating the issuers with higher than average final HHS notice of benefit and payment amount of the transfer reduction actuarial risk, HHS will assess other parameters. requested. For example, a State could relevant factors, including the premium Comment: A few commenters submit evidence and analysis detailing impact of the transfer reduction for the supported providing States the the effect of a State rating rule that State market. flexibility to request transfer reductions might lead to a portion of the State The approved reductions will be in the individual, small group and average premium that does not precisely made on the calculated risk adjustment merged markets, noting that the risk reflect the cost of relative differences in transfer amounts, rather than the adjustment program has been a barrier actuarial risk in the individual, small Statewide average premium as to entry for issuers in certain States. proposed, prior to the application of the These commenters stated such a group or merged market. The State high-cost risk pool adjustments (high- reduction to transfers could enable request must specify in detail the State- cost risk pool payment and charge issuer participation in the individual, specific rules or market dynamics that amounts). Applying the reduction is small group and merged markets. warrant an adjustment to the HHS risk simply a mathematical operation and Additionally, these commenters noted adjustment methodology to more applying it on the otherwise calculated the expense of operating a State-based precisely account for the expected cost transfer amounts will result in the same risk adjustment program limits States of relative risk differences in the State’s final transfer amount mathematically as from establishing their own risk individual, small group or merged if the reduction was applied to the adjustment methodologies. A few State market. Additionally, the State must Statewide average premium, but will regulators noted their intent to consider submit evidence and analysis justifying simplify the process for submission, the reduction and potential impacts for the reduction percentage requested. To review and calculation of the reductions future benefit years, and requested ‘‘off- justify the amount of the transfer to transfers. cycle’’ dialogues with HHS to consider reduction requested, the State’s We are finalizing modified timelines such reductions. evidence and analysis must explain how and adding paragraphs (d)(2) and (d)(3) Several commenters supported the the requested transfer adjustment was at § 153.320 to capture the timeframe for reduction to transfers only for the small determined by outlining the set of State- submission and publication of State group market, noting that the adverse specific factors and the percentage requests to reduce transfers in the selection in the individual market reduction warranted to account for individual, small group and merged requires the risk adjustment program to those factors in the State’s market; or markets in response to comments. We ensure competitive and stable markets. alternatively, it must demonstrate the are not finalizing this proposed policy These commenters noted such a requested reduction in risk adjustment for the 2019 benefit year, in order to reduction to transfers would be payments would be so small for issuers accommodate the evidence and analysis detrimental to market stability in the who would receive risk adjustment required and to provide more time for individual market, with one commenter payments, that the reduction would the development and review of such noting that unexpectedly large charges have a de minimis effect on the requests. Additionally, we believe the were a risk for issuers in the early years necessary premium increase to cover the requests should be published in the of the program and the markets have affected issuer’s or issuers’ reduced relevant benefit year’s proposed HHS since stabilized. A few commenters payments. In the latter case, a State notice of benefit and payment noted that HHS should allow States to must demonstrate that the reduced risk parameters to seek comment from permit reductions in merged markets as adjustment payments would result in relevant stakeholders. As such, well, while others noted this policy less than a 1 percent increase in the consistent with paragraph (d)(2), should not be made available in merged affected issuer’s or issuers’ premiums. beginning with 2020 and future benefit markets given the impact on individual We are adding paragraph (d)(1) to years, States must submit requests with market dynamics in the merged market § 153.320 to specify the submission the supporting evidence and analysis by States. Yet a few commenters suggested requirements for the State requests, as August 1st, 2 calendar years prior to the the flexibility be allowed across the outlined above. We are also adding beginning of the applicable benefit year individual, small group and merged paragraph (d)(4) to specify that HHS (for example, August 1, 2018, for the markets. One commenter noted that will approve the State requests if, based 2020 benefit year) to such a reduction would be appropriate on a review of the information [email protected] in the individual market as well to submitted as part of the State request, with the subject ‘‘[Insert applicable reduce carrier-specific transfers to along with other relevant factors, benefit year] State request to reduce risk adjust for administrative costs, limit including the premium impact of the adjustment transfers.’’ This modified distortions due to how many family transfer reduction for the State market, timeline responds to comment received members are counted toward premiums, and relevant public comments, HHS and provides States the opportunity to or prevent perverse incentives to avoid determines that the State-specific factors review the most recent year of risk care management or network variations warrant an adjustment and the State adjustment transfers data in determining that lower costs. request includes support justifying the the requested percentage reduction to Other commenters did not support a percentage reduction requested or transfers and when submitting the reduction to the risk adjustment includes information demonstrating that supporting evidence. As outlined in transfers, stating the reduction to

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transfers would undermine affordability methodology appropriately accounts for HHS risk adjustment methodology. of plans with sicker patients. these market differences because the Therefore, a State requesting a reduction Commenters were also concerned that lower adverse selection is reflected in of up to 50 percent of transfers in its providing such reductions would the lower risk score differential. small group market must provide encourage risk selection behavior by Commenters noted that Oliver Wyman, supporting evidence and analysis issuers, encourage risk segmentation in American Academy of Actuaries, and outlining the State-specific factors that the markets, reduce effectiveness of the HHS’s studies have all shown the risk warrant an adjustment to the HHS risk risk adjustment program, lead to higher adjustment program is working as adjustment methodology to more premiums for small employers and intended in mitigating adverse precisely account for relative risk consumers where issuers with higher selection. A few commenters also noted differences in that State market than average risk are not adequately a study by Oliver Wyman 21 that compared to the national norm, rather compensated for their risk, reduce suggested reducing transfers by up to 50 than demonstrating the factors that are choices for consumers even further, and percent may make the risk adjustment addressed in the current methodology. destabilize the markets. Commenters program less effective in compensating States must also justify the amount stated the importance of the risk plans with higher than average risk and requested by outlining how the adjustment program in promoting would therefore increase issuers’ risk percentage reduction would more competition in the individual, small selection incentives. Additionally, one precisely account for risk differences in group, and merged markets by commenter noted that the significant the State’s individual, small group or mitigating the issuers’ risk of adverse adjustments to the risk adjustment merged market or by demonstrating that selection. Commenters noted that the program being implemented for the the reduction in risk adjustment risk adjustment methodology already 2017 and 2018 benefit years should be payments would have a de minimis adjusts for a multitude of State- and evaluated prior to making any effect on the necessary premium rating area-specific factors as the additional changes. increase to cover the affected issuer or Response: In certain State individual, methodology calculates risk scores at issuers’ reduced payments. HHS will small group or merged markets, it is the individual level, and transfers at the not approve State requests for reduction possible that the HHS risk adjustment rating area level. A few commenters also to transfers based on factors in the methodology, which is calibrated on a noted that maintaining risk adjustment State’s individual, small group or national dataset, may not reflect State- as is would become increasingly merged market that are addressed by the specific factors that could result in important, especially if HHS were to current HHS risk adjustment relative risk differences in the State’s methodology. move forward with the EHB flexibilities market(s) compared to the national discussed elsewhere in this rule, as norm. Such unique State rules or other We appreciate commenters’ concerns issuers could enroll differential risk relevant factors could support a about extending the flexibility to the enrollees based on the EHBs offered. reduction to the otherwise applicable individual or merged markets. We Commenters noted that if HHS finalizes risk adjustment transfers to more believe that those enrolled in the the policy to permit requests for precisely account for the differences in individual or merged markets typically adjustments in the small group market, relative actuarial risk in the State’s have higher actuarial risk, risk selection, issuers would no longer have an individual, small group or merged and risk segmentation in plan selection incentive to enroll all types of market. We agree with commenters that, than those enrolled in the small group employers and could target healthier in such instances, allowing certain market, and risk adjustment transfers employers in certain sized employers State-specific adjustments to the are particularly required in these through marketing and other strategies. otherwise applicable transfers can tailor markets to mitigate issuers’ risk of Additionally, commenters noted that if the HHS-operated risk adjustment adverse selection and incentives to relative risk for health conditions in an program to the particularities of a State’s avoid risk. However, we recognize that, individual State is substantially individual, small group or merged just as with certain States’ small group different than the national average, it is market without requiring the State to markets, it is possible that certain not clear that a reduction of 50 percent undertake operation of its own risk factors unique to the States’ individual to risk adjustment transfers would be adjustment program or pursue a section or merged market, such as State rating appropriate, and the State ought to 1332 waiver to implement a reinsurance requirements, could support a reduction consider developing its own risk program. In those circumstances, in to transfers in that State market, and adjustment model to address significant which States can provide evidence and therefore are finalizing the State deviations in the State’s risk profiles analysis showing the State-specific rules flexibility to request reduction to that deviate from the national average or or market dynamics that warrant an otherwise applicable risk adjustment use the section 1332 of PPACA waiver adjustment to the HHS risk adjustment transfers in the individual and merged process to implement a reinsurance type methodology to more precisely account markets as well. We note that program. Commenters agreed with HHS for the relative risk differences in the guaranteed availability, guaranteed that the smaller magnitude of transfers State’s market, HHS will consider renewability, as well as the non- in the small group market than in the requests to reduce transfers beginning discrimination provisions at individual market indicates the lower with the 2020 benefit year. We agree §§ 147.104(e), 147.110 and 156.125(a), adverse selection risk in the small group with commenters that the small group provide protections against potential market, but stated that the HHS risk market features, such as employers’ employment of marketing practices or adjustment program is properly selection of plans, and minimum benefit designs that have the effect of calibrated for this lower risk of adverse participation and contribution rules, avoiding less healthy employer groups, selection in the small group market. that lead to lower risk of adverse discriminating based on health Commenters noted that while employer selection compared to the individual conditions, or otherwise discouraging contributions, employer choice of market are addressed in the current enrollment of individuals with benefit plans, and participation rules significant health needs. Finally, mitigate selection in the small group 21 Available at http://health.oliverwyman.com/ allowing for the State flexibility for the market, the risk adjustment transform-care/2017/11/risk_adjustment.html. 2020 benefit year, will allow us to assess

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the impact of the changes made to the adjustment factor, an attestation that the proposed rulemaking for the respective risk adjustment program beginning for percent reduction requested results in a benefit year and make the supporting the 2017 and 2018 benefit years, and we risk adjustment methodology that evidence publicly available for intend to monitor the impact of the complies with Actuarial Standard of comment, and consider the relevant changes to the risk adjustment program. Practice (ASOP) 12, Risk Classification, comments in its review. We note that States will also have the opportunity to and an assessment of adverse selection the data integrity issues flagged by assess the effects of the risk adjustment effects that may result from the commenters are assessed during the model changes implemented for the implementation of the payment transfer EDGE server data quality and quantity 2017 benefit year prior to submitting reduction. A few commenters also assessments, as well as through the risk any State requests to reduce transfers for suggested HHS require States to provide adjustment data validation program. the 2020 benefit year. evidence that issuers with large charges Comment: Commenters generally Comment: A few commenters noted in the risk adjustment program did not requested additional time for States to the extent of the reduction seemed have issues related to coding, submit requests. Commenters noted that arbitrary or too high, and requested HHS operational data submission, incorrect if HHS were to move forward with this explain how it chose the 50 percent rate setting, or suboptimal provider proposal, the agency should consider adjustment threshold. Commenters also contracting and medical expenses that implementing the policy in 2020, as this suggested that HHS should finalize a contributed to their risk adjustment policy will affect small group policies smaller percentage reduction if it results rather than differences in the that are offered starting on and after finalizes the proposal. One commenter State risk pool compared to the national January 1, 2018, as small group plans stated that it is equally likely that a average. are not offered on a calendar year basis, State needs to increase the risk and quarterly rate filings, which would Response: We agree with commenters adjustment transfers and HHS ought to already be in effect, would adversely that States should be required to submit allow for this type of a request as well. affect these plans. One commenter evidence and analysis supporting the Response: We are clarifying that the suggested HHS set the State request requests for reductions to transfers in adjustment applicable to a State deadline at 30 days after the June 30, the individual, small group or merged individual, small group or merged 2018 risk adjustment summary report or market, and therefore, are requiring that market would not necessarily be 50 request State submissions for the 2020 States requesting a reduction in risk percent, but would be the amount, up to benefit year before August 2018. Other 50 percent, justified by the State adjustment transfers submit supporting commenters suggested HHS allow States request. HHS reviewed transfers, the evidence and analysis to HHS. We are to provide the requests and any potential impact of such a reduction on requiring States to submit supporting supporting material 60 days or 75 days market premiums and the proportion of evidence and analysis demonstrating from the publication of the proposed the transfers as a percent of issuers’ the State-specific rules or relevant rule. Most commenters agreed that HHS payments when considering the factors that warrant an adjustment to should provide an opportunity for appropriate threshold. We believe that more precisely account for risk comment for the issuers and other an adjustment of up to 50 percent, differences in the State’s individual, stakeholders in the States that make justified by State-specific factors, small group or merged market. such requests before approving or represents a reasonable balance between Additionally, we are requiring the States denying the reduction. One commenter adjustment for actuarial risk based on a to justify the percentage reduction also noted States require additional time national methodology and recognition requested based on supporting evidence to develop their respective requests and of unique State-specific factors that and analysis that demonstrate how the issuers require additional time to suggest that actuarial risk difference is adjustment would accommodate the communicate their position with State not precisely accounted for by the State-specific factors and more precisely regulators than that allowed by the national methodology. In instances account for risk differences in the timing in the proposed rule. where a State believes that an increase State’s individual, small group or Response: We appreciate commenters’ to risk adjustment transfers would be merged market or how the reduction suggestions regarding timing, and are appropriate, State regulators under their would have a de minimis effect on the finalizing modified timelines for States own State authority could take actions percent of premium increase necessary to request a reduction to the risk outside of this flexibility to ease the to cover the reduced payments to the adjustment transfers in response to transition for new entrants and/or affected issuers. We considered but are these comments. As discussed above, mitigate the effects of large risk not requiring States to submit States will be permitted to request these adjustment transfers. States can also actuarially certified reports, an adjustments to transfers beginning for elect to establish and operate the attestation, or simulation of the the 2020 benefit year. We agree with PPACA risk adjustment program. potential effects of the requested commenters that small group market Additionally, we do not believe that an reduction as part of their requests. We issuers may have already begun policies increase to the transfers could be determined that to ensure issuers are that would be affected by a reduction to deemed necessary as the current adequately compensated for the transfers for the 2019 benefit year, and methodology would be sufficient to actuarial risk of their enrollees and do issuers may need additional time to calculate the transfers necessary to not have incentives to avoid higher risk incorporate changes and reflect any compensate for the relative actuarial enrollees, the State regulators need to reduction to transfers in their rates. risk differences scaled to the average submit evidence and analysis Additionally, for the individual, small cost for the State market. demonstrating the State-specific factors group and merged markets, we also Comment: Some commenters noted that warrant an adjustment to more considered the amount of time State that States should be required to submit precisely account for the differences in regulators would require to assemble the an actuarially certified report actuarial risk in the State’s market, and supporting evidence and analysis to demonstrating the extent to which the justifying the percent reduction justify their requests and to consider the transfers overstate differentials in requested based on the State factors or annual HHS June 30th risk adjustment uncompensated predicted risk, the a de minimis effect. Additionally, HHS transfers calculation results in method of estimating the requested will publish the requests in the determining the State reduction request.

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The timeframe we are adopting in including the delayed application of any local approaches under State legal response to comments requires States to this policy until the 2020 benefit year, authority are warranted to help ease the submit the request by August 1st, 2 are intended to provide States, issuers transition for new participants to the calendar years prior to the applicable and other stakeholders with sufficient health insurance markets. States that benefit year which will allow States to opportunity to develop, submit and take such actions and make adjustments submit documentation to satisfy the comment on these reduction requests do not generally need HHS approval as supporting evidence and analysis prior to finalization of the HHS-operated these States are acting under their own requirements in this rule and risk adjustment methodology for the State authority and using State incorporate the most recent available applicable benefit year. resources. However, the flexibility year of HHS risk adjustment transfer Comment: A few commenters noted finalized in this rule involves a results in the State’s request. that New York has already taken action reduction to the risk adjustment to reduce transfers under the State’s Additionally, we agree with transfers calculated by HHS and will authority, and requested clarification commenters about the importance of require HHS review as outlined above. whether other States could continue to providing issuers and stakeholders an take steps under existing State iv. The Payment Transfer Formula opportunity to comment on the request authority. One commenter noted that and supporting evidence. As outlined in the New York adjustment could be seen The finalized State payment transfer paragraph (d)(3) of § 153.320, HHS will as permitting States to make formula for the 2019 benefit year is publish the requests in the respective adjustments without HHS approval and unchanged from what was finalized in benefit year’s proposed HHS notice of requested clarification that States the 2014 Payment Notice (78 FR 15430 benefit and payment parameters and making adjustments to the risk through 15434). We believe it useful to make the supporting evidence available adjustment formula must first obtain republish the formula in its entirety. to the public to seek comment from approval from HHS under the risk Transfers (payments and charges) will relevant stakeholders, and will publish adjustment program prior to be calculated as the difference between any final approved or denied reduction implementing any State-specific the plan premium estimate reflecting amounts in the final HHS notice of adjustments. risk selection and the plan premium benefit and payment parameters for the Response: As we noted above, States estimate not reflecting risk selection. respective benefit year. The modified are the primary regulators of their The State payment transfer calculation timelines and supporting evidence insurance markets, and as such, we that is part of the HHS risk adjustment requirements finalized in this rule, encourage States to examine whether payment transfer formula is:

Where: and charges. This resulting PMPM plan calculation, we will use a percent of P¯ S = Statewide average premium; payment or charge is multiplied by the premium adjustment factor that is PLRSi = plan i’s plan liability risk score; number of billable member months to applied to each plan’s total premium AVi = plan i’s metal level AV; determine the plan payment or charge amounts, rather than the percent of ARFi = allowable rating factor; based on plan liability risk scores for a PMPM premium adjustment factor for IDFi = plan i’s induced demand factor; plan’s geographic rating area for the risk simplicity; and reiterate that the GCFi = plan i’s geographic cost factor; pool market within the State. mathematical outcome is the same. si = plan i’s share of State enrollment; Beginning with the 2018 benefit year, With the high-cost risk pool The denominator is summed across all the high-cost risk pool adjustment adjustment amount, the total plan plans in the risk pool in the market in amount will be added to the plan transfers would be calculated as the the State. transfers (payment or charge) to account product of the plan PMPM transfer The difference between the two for: (1) The payment term, representing amount (T ) multiplied by the plan’s premium estimates in the State payment i the portion of costs above the threshold billable member months (M ), plus the transfer calculation determines whether i reimbursed to the issuer for high-cost high-cost risk pool adjustments. The a plan pays a risk adjustment charge or risk pool payments (HRPi), if applicable, total plan transfer (payment or charge) receives a risk adjustment payment. The and (2) the charge term, representing a amounts under the HHS risk adjustment value of the plan average risk score by percent of premium adjustment, which payment transfer formula would be itself does not determine whether a plan is the product of the high-cost risk pool calculated as follows: would be assessed a charge or receive a adjustment factor (HRPCm) for the ¥ payment—even if the risk score is respective national high-cost risk pool Total transferi = (Ti · Mi) + HRPi greater than 1.0, it is possible that the m (one for the individual market, (HRPCm · Pi) plan would be assessed a charge if the including catastrophic, non-catastrophic Where:

premium compensation that the plan and merged market plans, and another Ti = Plan i’s PMPM transfer amount; may receive through its rating (as for the small group market), and the Mi = Plan i’s billable member months; measured through the allowable rating plan’s total premiums (Pi). As we noted HRPi = Plan i’s total high-cost risk pool factor) exceeds the plan’s predicted above, the percent of premium payment; liability associated with risk selection. adjustment factor applied to a plan’s HRPCm = High-cost risk pool percent of Risk adjustment transfers are calculated total premium amounts results in the premium adjustment factor for the at the risk pool level, and catastrophic same adjustment as a percent of PMPM respective national high-cost risk pool m; Pi = Plan i’s total premium amounts. plans are treated as a separate risk pool premium adjustment factor applied to a for purposes of the risk adjustment plan’s PMPM premium amount and In States that requested a reduction to transfer calculation, not including the multiplied by the plan’s number of transfers in the individual, small group national high-cost risk pool payments billable member months. For this or merged market, the reduction

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percentage up to 50 percent, if approved adjustment data validation pilot for the a group of HCCs is statistically different by HHS for the applicable benefit year 2015 benefit year reinforce this belief. from the weighted mean failure rate, or beginning with the 2020 benefit year, To avoid adjusting all issuers’ risk total failure rate, for that group of HCCs would be applied to the plan PMPM adjustment payments for expected for all issuers that submitted initial payment or charge transfer amount (Ti). variation and error, we proposed validation audits. We are selecting this This potential reduction to the PMPM evaluating material statistical deviation approach based on comments received, transfer amounts is not shown in the in error rates beginning with 2017 which generally were more supportive risk adjustment transfer formula above. benefit year risk adjustment data of the HCC or HCC-grouping validation. In the proposed rule, we methodology for evaluating failure rates g. Risk Adjustment Data Validation explained that we were considering than an approach under which we Requirements When HHS Operates Risk adjusting an issuer’s risk score only would calculate a national overall error Adjustment (§ 153.630) when the issuer’s error rate materially rate. Additionally, we believe HHS will conduct risk adjustment deviates from a statistically meaningful determining outlier failure rates based data validation under § 153.630 in any value, such as the central tendency (a on HCC groups mitigates gaming State where HHS is operating risk mean or typical value) of errors, concerns raised by commenters in using adjustment on a State’s behalf.22 The nationally. When an error rate a national error rate, and mitigates purpose of risk adjustment data materially deviates from the central commenters’ sample size concerns in validation is to ensure issuers are tendency, we proposed to apply the using HCC-specific failure rates. Our providing accurate high-quality difference between the mean error rate simulations of failure rates by HCC information to HHS, which is crucial for or the confidence interval around the group suggest that such an approach the proper functioning of the risk population’s central tendency and the yields a more equitable measure to adjustment program. Risk adjustment calculated error rate instead of the full evaluate statistically different HCC data validation consists of an initial error rate. If all error rates in a State risk failure rates affecting an issuer’s error validation audit and a second validation pool do not materially deviate from the rate than an approach based on an audit. Under § 153.630, each issuer of a national central tendency of error rates, overall failure rate, which may overly risk adjustment covered plan must we proposed to not apply any adjust issuers with abnormal engage an independent initial validation adjustments to issuers’ risk scores for distributions of certain HCCs due to audit entity. The issuer provides that benefit year in the respective State their underlying populations rather than demographic, enrollment, and medical risk pool. differences due to errors in diagnoses record documentation for a sample of We also noted that alternatively, HHS codes. Illustrations of the methodology enrollees selected by HHS to its initial could evaluate error rates within each we will use to evaluate failure rate validation auditor for data validation. HCC, or groups of HCCs, and then only differences by HCC group, calculate Set forth below are final amendments apply error rates to outlier issuers’ risk error rates based on failure rates, and and clarifications to the risk adjustment scores within each HCC or group of apply error rates to risk scores are data validation program in light of HCCs. In evaluating the ‘‘error rate’’ of provided below. experience and feedback from issuers HCCs, or groups of HCCs, we mean the Using data from the 2017 benefit year during the first pilot year. probability of an assigned HCC being risk adjustment data validation, HHS found to be incorrect based on the risk will first calculate the failure rate for i. Payment Adjustments for Error Rates adjustment data validation audit, or a each HCC in issuers’ initial validation Under § 153.350(c), HHS may adjust ‘‘failure rate.’’ The percent of the EDGE audit samples as: risk adjustment payments and charges risk score that is incorrect due to audit to all issuers of risk adjustment covered findings (that is, due to HCCs that could plans based on adjustments to the not be validated through audit), we average actuarial risk of a risk consider to be the issuer’s risk score Where: error rate. For example, an issuer could adjustment plan due to errors Freq_EDGEh is the frequency of HCC code h discovered during risk adjustment data have a 50 percent failure rate for an occurring on EDGE, which is the number validation. Under the original risk HCC, in that two of four instances of the of sampled enrollees recording HCC code adjustment data validation payment HCC on EDGE could not be validated. h on EDGE. _ h adjustment approach, all issuers of risk The impact of HCC failure rates on an Freq IVA is the frequency of HCC code h issuer’s error rate will then depend on occurring in IVA results, which is the adjustment covered plans would receive number of sampled enrollees with HCC an adjustment to payment transfers in the magnitude of the missing HCC’s coefficient and the incidence of that code h on in IVA results. the subsequent benefit year based on FRh is the failure rate of HCC code h. risk adjustment data validation audit HCC in the audit sample. We believe the implementation of any HHS will then create three HCC results and using the audit-confirmed, of the alternative evaluations and groups based on the HCC failure rates issuer-specific risk score error rate. subsequent adjustments we proposed derived in the calculation above. These However, we believe that some variation would streamline the risk adjustment HCC groups will be determined by first and error should be expected in the data validation process, improve ranking all HCC failure rates and then compilation of data for risk scores, issuers’ ability to predict risk dividing the rankings into three groups, because providers’ documentation of adjustment transfers, and promote weighted by total observations or enrollee health status varies across confidence and stability in the budget- frequencies, of that HCC across all provider types and groups. Our neutral payment transfer methodology, issuers’ initial validation audit samples, experiences with the Medicare while ensuring the integrity and quality to assign each unique HCC in the initial Advantage risk adjustment data of data provided by issuers. validation audit samples to a high, validation program and the HHS risk We are finalizing the approach medium, or low failure rate group with described above of using failure rates an approximately even number of 22 Starting with the 2017 benefit year, no State has elected to operate a risk adjustment program. specific to HCC groups and observations in each group. That is, Therefore, HHS operates risk adjustment in all subsequently adjusting the issuer’s risk each HCC group may have an unequal States. score when the issuer’s failure rate for number of unique HCCs, but the total

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observations in each group should be HHS will then compare each issuer’s issuer’s HCC group failure rate will be approximately equal based on total failure rate for each HCC group based on compared to the weighted mean failure observations of HCCs reflected in EDGE the number of HCCs validated in the rate, or total failure rate, for that HCC data for all issuers’ initial validation initial validation audit, compared to the group. We calculate an issuer’s HCC audit sample enrollees, to prevent small number of HCCs recorded on EDGE group failure rate as: sample sizes for an HCC group for any within that HCC group for the initial issuer. validation audit sample enrollees. The

We will also calculate the weighted mean failure rate and the standard deviation of each HCC group as:

If an issuer’s failure rate for an HCC Where: Specifically, this will result in the group falls outside the confidence sigma_cutoff is the parameter used to set the sample enrollees’ applicable HCC risk interval for the weighted mean failure threshold for the outlier detection as the score components being reduced (or rate for the HCC group, the failure rate number of standard deviations away increased) by a partial value, or for the issuer’s HCCs in that group from the mean. percentage, calculated as the difference LBG, UBG are the lower and upper thresholds would be considered an outlier. We will between the outlier failure rate for the use a 1.96 standard deviation cutoff, for to classify issuers as outliers or not outliers for group G. HCC group and the weighted mean a 95 percent confidence interval, to failure rate for the applicable HCC identify outliers. To calculate the When an issuer’s HCC group failure group. The adjustment amount for thresholds to classify an issuer’s group rate is an outlier, we will reduce (or outliers will be the distance between failure rate as outliers or not, the lower increase) each of the applicable initial i issuer i’s Group Failure Rate GFR G and and upper limits are computed as: validation audit sample enrollees’ HCC the weighted mean m(GFRG), calculated G m G ¥ _ coefficients by the difference between LB = (GFR ) sigma cutoff * as: Sd(GFRG) the outlier issuer’s failure rate for the UBG = m(GFRG) + sigma_cutoff * HCC group and the weighted mean Sd(GFRG) failure rate for the HCC group.

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The adjustment to an enrollee’s total AIDS HCC and the issuer’s HCC group enrollee’s HIV/AIDS coefficient would risk score is calculated as the ratio of the adjustment rate is 10 percent (the be reduced by 10 percent. We calculate total adjusted risk score for individual difference between the issuer’s group the total adjustment amount across all HCCs to the total risk score components failure rate and the weighted mean HCCs per enrollee as: for individual HCCs. For example, if an failure rate) for the HCC group that issuer has one enrollee with the HIV/ contains the HIV/AIDS HCC, the

The adjusted risk score for enrollee e of We will then calculate an issuer’s the enrollee, to extrapolate the sample issuer i is calculated as: error rate using the EDGE risk score and adjusted risk scores and determine the AdjRSi,e = EdgeRSi,e * (1 ¥ adjusted risk score for all enrollees in issuer’s risk score error rate. The Adjustmenti,e) the sample (excluding enrollees with no formula to compute the error rate using Where: HCCs). The weight we in the error rate the stratum weighted risk score for calculation formula is obtained by the EdgeRSi,e is the risk score for EDGE HCCs of issuer i before and after the adjustment enrollee e of issuer i. ratio of an enrollee’s stratum size in the is shown as: AdjRSi,e is the adjusted risk score for sampled issuer’s population to the number of enrollee e of issuer i. sample enrollees in the same stratum as

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The risk score error rate would then note that we intend to propose updates rates should improve and stabilize, be applied to the subsequent benefit to the sampling methodology for the rather than grow. year calculated plan level risk scores, to 2018 benefit year HHS-operated risk Comment: Several commenters adjust the issuer’s plan level risk scores adjustment data validation initial recommended that HHS provide issuers before risk adjustment transfers are validation audit samples in the 2020 with more transparency about the calculated, unless the issuer exited the Payment Notice. calculation of error rates, as well as market during or at the end of the benchmark national and State-level 23 Comment: One commenter supported benefit year being audited. the proposed application of the error rate data against which issuers Comment: Most commenters difference between the calculated error could evaluate their performance supported the proposal to only adjust relative to other issuers and in the issuers’ risk scores if their failure or rate and the statistically meaningful value, instead of the full error rate, to context of this proposal. Two error rates materially deviate from a commenters suggested that HHS apply the issuer’s subsequent year risk score statistical mean, with some noting that the proposed approach to the 2016 when material deviation occurs. One this approach could help streamline risk benefit year pilot results to illustrate commenter opposed the proposal due to adjustment data validation and increase how issuers’ risk scores and payment concerns that if the average failure rate market stability. A few commenters transfers might be affected in future is exceedingly high or increasing, it noted the complexity of the approach years. could encourage issuers to be less and requested more information on Response: We appreciate the accurate over time in their risk various aspects of the proposed recommendations, and we intend to approach, such as the definitions of adjustment data, as long as they are not publish benchmark failure and error rate material deviation and statistically outliers relative to other issuers. data based on the results of the 2016 meaningful value, the methodology that Another commenter expressed concerns benefit year data validation second pilot HHS would use to evaluate material that issuers within the calculated year. We also intend to provide deviation, the calculation of national or confidence interval would receive no additional information to issuers about HCC-level error rates, and the adjustments, while issuers outside of risk score error rates based on 2016 sufficiency of the sample sizes under the confidence interval would receive benefit year risk adjustment data the HCC or group of HCCs approach. substantial and punitive adjustments. validation results, prior to Response: As outlined above, for the Response: The primary purpose of implementation in 2017 benefit year purposes of risk adjustment data determining statistically meaningful risk adjustment data validation. In validation, we will determine that an differences is to avoid the unwarranted addition, illustrations of the issuer’s failure rate is statistically application of risk score adjustments— methodology we will use to evaluate different if the issuer’s failure rate for a that is, risk scores would be adjusted failure rate differences by HCC group, particular HCC group is more than 1.96 only when the issuers’ failure rates are calculate error rates based on failure standard deviations away from the outside a range of statistically rates and apply error rates to risk scores weighted mean failure rate for the high, acceptable errors. We believe that are provided above. medium, or low HCC group. Issuers statistically meaningful errors should be Comment: Two commenters with outlier failure rates in a particular adjusted to the weighted mean failure recommended that HHS continue to HCC group will then have their sample rate of each HCC group. We are study failure rates by HCCs or groups of enrollee risk scores adjusted by the finalizing an approach under which, HCCs for a longer period of time before difference between the issuer’s failure when an issuer’s failure rate for its proceeding with this approach, and rate and the mean failure rate for that associated HCCs in one of the HCC another commenter opposed the HCC group for all applicable HCCs in groupings is statistically different than calculation of failure rates at the HCC or their sample enrollees’ risk scores. We the mean for that grouping, HHS will HCC group-level. will not use an overall mean failure rate adjust the sample enrollees’ risk score Response: We evaluated the HCC or error rate to determine outliers under component for that HCC group by the group-level and other proposed the approach finalized in this rule. We difference between the issuer’s failure approaches using a simulation with believe that the HCC grouping approach rate for the HCCs in that group and the underlying Medicare risk adjustment described above, which utilizes three weighted mean failure rate for the HCC data validation failure rates, and we large HCC groupings, will mitigate the group for all issuers that submitted agree with commenters that additional risk of an issuer having a small sample initial validation audits. We will data from HHS-operated risk adjustment size for a particular HCC group. We also continue to evaluate this approach; data validation results in a payment however, we expect that as issuers and adjustment year would be preferable. 23 See section III.B.2.g.ii. of this rule, for a However, under the current error rate discussion of changes being finalized with respect initial validation auditors gain to payment adjustments for issuers that have exited additional experience performing risk estimation and application policy for the market. adjustment data validation, HCC failure HHS-operated risk adjustment data

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validation, all issuers’ risk scores and prospective approach to adjust risk beginning with the 2017 benefit year payment transfers would be adjusted, scores and payment transfers based on risk adjustment data validation. for any identified error, regardless of the results of risk adjustment data Therefore, for an issuer that exited a issuer size or distribution of HCCs in its validation. Specifically, HHS will apply State market during or at the end of the enrollee population beginning with the the error rate calculated through the risk 2017 benefit year who had a statistically 2017 benefit year data validation. We adjustment data validation process for meaningful error rate under the revised believe the approach being finalized in the applicable benefit year to plan risk approach to payment adjustments this rule will increase predictability of scores in the subsequent benefit year, finalized above in this rule, HHS would risk adjustment transfers for issuers, and and then make risk adjustment payment apply the risk score error rate to the improve our ability to identify transfers based on adjusted plan average issuer’s 2017 benefit year risk score, and statistically meaningful data risk scores in that subsequent benefit recalculate 2017 benefit year risk discrepancies in the data validation year. However, in some cases, an issuer adjustment transfers for the affected process. By focusing on issuer errors of a risk adjustment covered plan may State market risk pools. We note that, that are statistically meaningful, we can have exited a State market during or at under this timeline, issuers that exited adjust issuers’ risk scores with the end of the benefit year being audited a State market during or at the end of confidence, as opposed to adjusting all and therefore would not have risk scores 2017 benefit year have ample issuers for any difference, significant or or payment transfers in the subsequent opportunity to review and correct data not, from EDGE data. As such, we benefit year to which HHS could make submitted to their EDGE servers that believe implementing this approach as adjustments. will be used to calculate risk scores for soon as possible ensures the most As previously noted, the purpose of the 2017 benefit year. accurate payment adjustments and risk adjustment data validation is to Comment: The majority of promotes stability and predictability of promote confidence in the budget- commenters supported using the error risk adjustment transfers. neutral payment transfer methodology rate derived from data validation for the Comment: A few commenters raised by ensuring the integrity and quality of most recent benefit year in which an concerns that the calculation of a data provided from issuers. HHS exited issuer participated in risk national average error rate could fail to believes that the prospect of not adjustment to make an adjustment to account for State or regional variations receiving payment adjustments based on exited issuers’ risk adjustment transfers in provider coding practices, and the results of risk adjustment data for their final benefit year in the State therefore result in harmful adjustments validation results could undermine market, and to reallocate the adjusted that could discourage new entrants in these goals by eliminating the incentive amount to the other issuers in the State some States. for an exiting issuer to carefully and market in that year. Commenters agreed Response: We agree with commenters accurately submit risk adjustment data that a post-transfer adjustment, based on and believe the evaluation of failure rate for its final benefit year in the market. results of data validation for the most deviation by groups of HCCs, based on Not only could this type of inaccuracy recent benefit year for which the issuer HCC failure rates outlined above, rather result in overpayments to the exiting participated in risk adjustment, would than a single, national average failure issuer, it could also cause the other reduce the risk of gaming by an issuer rate for all HCCs, will mitigate the risk issuers in the market to be over or leaving a State market and ensure that of adjustments due to errors or undercompensated for the actual risk of other issuers remaining in the State differences that can be explained by their enrollee populations. Therefore, market are not harmed by an exited regional variation in provider we proposed that HHS would use the issuer’s incorrect or incomplete data. documentation of enrollee health status. error rate derived from the risk One commenter expressed concern that We will evaluate the impact of this adjustment data validation process to the adjustments for exited issuers would approach on issuers across regions and adjust the payment transfer for the complicate payment transfers and States and consider adjustments in issuer’s final benefit year in the State requested that HHS provide additional future years if there is evidence of market, which would be concurrent guidance or create a forum with issuers regional bias in payment adjustments with the benefit year being audited, for to discuss which method would result resulting from this policy. issuers that exit a State market during or in the least disruption to the data Comment: One commenter requested at the end of the benefit year being validation process over multiple years. that HHS conduct another pilot year audited. Because risk adjustment Response: We agree with commenters prior to implementing payment transfers for a given benefit year are who supported a post-transfer adjustments, since data validation is calculated and paid before the risk adjustment for issuers who exit the still new for issuers in the commercial adjustment data validation process for market during or at the end of a given market. that benefit year is completed, this benefit year, and we are finalizing the Response: While we will continue to approach would require HHS to make a policy as proposed. Adjusting an exited educate issuers about the HHS risk retroactive (that is, post-transfer) issuer’s payment transfer will help adjustment data validation process, we adjustment to the issuer’s payment ensure that an issuer with inaccurate or believe that it is necessary to use the transfer for its final benefit year and incomplete data does not benefit from results of data validation to adjust risk reallocate the adjusted transfer amount this error and that other issuers in the scores beginning with 2017 benefit year to the other issuers in the State market State market are not harmed by it. We data validation to encourage issuers to in that year. acknowledge that adjustments to final continue to improve the accuracy of We sought comment on this proposal benefit year payment transfers for data used to compile risk scores and to to make these adjustments to payment issuers that exited a State market could preserve confidence in the HHS- transfers for issuers that have exited the complicate the calculation of transfers; operated risk adjustment program. market based on the results of risk however, we believe the revised policy adjustment data validation for the most for error rate payment adjustments ii. Payment Adjustments for Issuers recent benefit year in which they finalized above will help mitigate the That Have Exited the Market participated in risk adjustment. We are potential complexity, because only In the 2015 Payment Notice, we finalizing this policy as proposed, and exited issuers with statistically established that HHS will use a we clarify that it will be effective meaningful failure rates will receive

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post-transfer adjustments. Furthermore, for small issuers, the determination of to an initial validation audit we believe the benefits associated with whether an issuer has 500 billable approximately every 3 years. HHS based applying adjustments to exited issuers’ member months or fewer will be the timeline for enforcement of the payment transfers, based on the results calculated Statewide (that is, combining materiality threshold on the expectation of risk adjustment data validation for an issuer’s enrollment in a State’s that we would begin making payment the most recent benefit year in which individual and small group markets in adjustments based on the results of the they participated in risk adjustment, a benefit year). 2016 benefit year risk adjustment data outweigh the complexities. For State Comment: A commenter agreed with validation, effectively requiring all market risk pools where HHS the proposal, but suggested that issuers issuers of risk adjustment covered plans determines that an issuer that exited the with 500 or fewer billable member to participate in the first benefit year for market will receive an adjustment to months be excluded from risk which risk adjustment payments are their risk adjustment transfer for their adjustment data validation entirely. One adjusted. However, in light of our final benefit year in the market, we commenter disagreed with the proposal subsequent decision to convert the 2016 intend to provide all issuers in the stating that all issuers should be subject benefit year to another pilot year,24 in affected prior year risk pool with the to audits for accountability. One the proposed rule, we proposed to adjustments for exited issuers at the commenter agreed with the proposal, postpone application of the materiality same time as adjustments for any issuers but wanted an option for small issuers threshold to the 2018 benefit year. remaining in the market are made in the to be adjusted by a default error rate Therefore, all issuers of risk adjustment subsequent benefit year. based on the issuer’s parent company’s covered plans would be required to aggregate or average error rate. conduct an initial validation audit for iii. 500 Billable Member Months Response: HHS recognizes that the 2017 benefit year risk adjustment Numerous small issuers have issuers’ company-level affiliations may data validation, other than issuers with expressed concern regarding the vary in size considerably, but note that 500 billable member months or fewer regulatory burden and cost associated regardless of parent company size, Statewide as discussed above. with complying with the risk issuers with 500 or fewer billable Beginning with the 2018 benefit year adjustment data validation program. member months Statewide face a risk adjustment data validation, issuers HHS has previously considered these relatively large burden in complying below the $15 million premium concerns and provided relief where with an initial validation audit where materiality threshold would not be possible. In the proposed rule, we the initial validation audit sample required to conduct an initial validation proposed that, beginning with 2017 would be the issuer’s entire population. audit every year. Under this proposal, benefit year risk adjustment data Consistent with the risk adjustment data HHS would still conduct random and validation, issuers with 500 billable validation error rate payment targeted sampling under which issuers member months or fewer that elect to adjustment policy finalized above, we below the materiality threshold would establish and submit data to an EDGE believe that only issuers with be subject to an initial validation audit server would not be subject to the statistically meaningful errors should approximately every 3 years, beginning requirement to hire an initial validation receive payment adjustments. We with 2018 benefit year risk adjustment auditor or submit initial validation audit believe that the implementation of this data validation.25 In addition, we results. We explained that we believe policy provides similar relief to smaller explained that if the proposed approach exempting issuers with 500 billable issuers for whom audits would have a for error rate payment adjustments member months or fewer from the disproportionately high cost and who, outlined in the proposed rule were to be requirement to hire an initial validation due to small size, are unlikely to have finalized, issuers below the $15 million auditor is appropriate because issuers of a significant or material impact on threshold that are not selected for the this size would have a adjustments to other issuers. We note random and targeted sampling might disproportionately high operational that the risk adjustment data validation not have their risk adjustment transfers burden for compliance with risk policies finalized in this rule result in adjusted for a given benefit year. adjustment data validation. We noted issuers with 500 or fewer billable We are finalizing the postponement of that, beginning with 2018 benefit year member months Statewide effectively the materiality threshold to 2018 benefit risk adjustment data validation, these being excluded from risk adjustment year risk adjustment data validation, as issuers would not be subject to random data validation, as they do not have to proposed. sampling under the materiality hire an initial validation auditor, submit Comment: One commenter agreed threshold discussed below, and would initial validation audit results, or be with the proposal. Another commenter continue to not be subject to the subject to risk adjustment data advocated for having a lower materiality requirement to hire an initial validation validation payment adjustments. threshold such as 12,000 or fewer auditor or submit initial validation audit billable member months. Some iv. Materiality Threshold for Risk results. We also explained that if the commenters stated that there should be Adjustment Data Validation approach for payment adjustments for no materiality threshold, and that all error rates outlined in the proposed rule In the 2018 Payment Notice, HHS issuers should be subject to risk were finalized, then it would be implemented a materiality threshold for adjustment data validation. possible that no adjustment would risk adjustment data validation to ease occur for issuers below this threshold. the burden of annual audit requirements 24 ‘‘HHS-Operated Risk Adjustment Data We sought comments on the proposal, for smaller issuers of risk adjustment Validation (HHS–RADV)—2016 Benefit Year including the 500 billable member covered plans. Specifically, we stated Implementation and Enforcement.’’ May 3, 2017. Available at https://www.regtap.info/uploads/ month threshold. that issuers with total annual premiums library/HRADV_PilotGuidance_5CR_050317.pdf. We are finalizing the exemption for at or below $15 million (calculated 25 In the 2018 Payment Notice, we stated that we issuers with 500 billable member based on the premiums of the benefit would consider risk-based metrics such as an months or fewer as proposed. We clarify year being validated) would not be issuer’s prior year risk adjustment data validation results and material changes to data submission, as that, consistent with the approach in the subject to annual initial validation audit measured by our quality metrics, in selecting 2017 Payment Notice for the lower, requirements, beginning with the 2017 issuers below the materiality threshold for more separate risk adjustment default charge benefit year, but would still be subject frequent initial validation audits.

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Response: Although we appreciate the year data validation, the initial data documentation from providers of comments, we did not propose and are validation audit sample would only services to each enrollee in the not modifying the level at which the include enrollees from State risk pools applicable sample without unreasonable materiality threshold is set in this rule. in which there was more than one delay and in a manner that reasonably The proposal addresses the timing for issuer.27 We are finalizing this policy as assures confidentiality and security in implementation of the threshold and the proposed. transmission. Issuers have advised HHS applicability of potential adjustments to Comment: One commenter stated that that certain States’ medical privacy laws risk adjustment transfers for issuers at or the proposed approach to allow sole may limit providers’ ability to furnish below the $15 million threshold. All issuers to participate in another market mental and behavioral health records for issuers of risk adjustment covered plans in the State where it is not the sole risk adjustment data validation will be required to conduct an initial issuer has the potential to create market purposes. As we explained in the validation audit for the 2017 benefit instability, as non-similar plans are proposed rule, we believe that section year risk adjustment data validation, brought into the calculation. 1343 of the PPACA and associated other than issuers with 500 billable Response: We clarify that, under the regulations require issuers of risk member months or fewer Statewide as finalized policy, HHS would only adjustment covered plans to furnish any discussed above. Beginning with the sample from the issuer’s risk pool where records needed for purposes of the risk 2018 benefit year, issuers at or below it is not the only issuer in the risk pool adjustment program, including mental the $15 million premium threshold will for the initial validation audit. and behavioral health records, and that not be required to conduct an initial Currently, the initial validation audit the HIPAA Privacy Rule at 45 CFR validation audit every year. HHS will sample pulls from an issuer’s 164.512(a) generally permits disclosures still conduct random and targeted population across a State, irrespective of of protected health information that are sampling under which issuers below the risk pool. The finalized policy ensures required by law within the meaning of materiality threshold would be subject that only enrollee data for which risk § 164.103. Nevertheless, we recognize to an initial validation audit adjustment transfers were calculated in that some State and Federal privacy approximately every 3 years, beginning a risk pool are validated. laws impose requirements for mental with 2018 benefit year risk adjustment Comment: One commenter disagreed and behavioral health information that data validation. Under the policy with our proposal due to concerns about are different from, and potentially more finalized in this rule with respect to accountability of sole issuers. restrictive than, the HIPAA regulations. Response: For issuers that are the sole error rate payment adjustments, issuers However, without the necessary mental issuer in a risk pool, there is no risk below the $15 million materiality and behavioral health information, the adjustment transfer and thus, there is no threshold that are not selected for the diagnosis code for an applicable payment or accountability to other random and targeted sampling will not enrollee cannot be validated and, issuers in that risk pool. As explained have their risk adjustment transfers therefore, it would be rejected during above, HHS will not calculate a risk adjusted. risk adjustment data validation. score or risk adjustment payment To address these potential issues, we v. Data Validation Sampling transfers, on behalf of a State in a Methodology proposed to amend § 153.630(b)(6) to market and risk pool in which there is provide that, if a provider is prohibited Section 153.350(a) requires that a only one issuer, except for high-cost risk from furnishing a full mental or statistically valid sample of enrollees pool transfers beginning with the 2018 behavioral health record by State or from each issuer of risk adjustment benefit year, and data submitted for Federal privacy laws, the provider covered plans be validated. In the 2015 high-cost risk pool transfers by all instead may furnish a mental or Payment Notice, HHS finalized its issuers will be subject to a separate behavioral health assessment that methodology for selecting the sample of audit. Therefore, we are finalizing the providers routinely prepare, for enrollees for the initial validation audit proposal to change the sampling validation of a mental or behavioral for each issuer of a risk adjustment methodology so that, beginning with health diagnosis. We explained that, covered plan. We established a sample 2017 benefit year risk adjustment data although HHS needs the full content of size per issuer for each State in which validation, the initial validation audit the mental or behavioral health record the issuer offers risk adjustment covered sample will only include enrollees from to ensure full validation of the accuracy plans.26 In the proposed rule, we State risk pools in which there was explained that HHS would not calculate of diagnosis codes, we believed that we more than one issuer and where HHS can still perform some risk adjustment a risk score, or apply risk adjustment conducted risk adjustment on behalf of payment transfers except for high-cost data validation based on the information the State for the benefit year being contained in mental or behavioral risk pool transfers beginning with the validated. 2018 benefit year, on behalf of a State health assessments in those instances in in a market and risk pool when there is vi. Mental and Behavioral Health which State or Federal law prohibits only one issuer in the market and risk Records submission of the full record. For risk pool. In addition, we proposed that the Under § 153.630(b)(6), the issuer of a adjustment data validation purposes, we issuer would not be required to validate risk adjustment covered plan must would expect a mental or behavioral data for its plans in a risk pool that was provide the initial validation auditor health assessment to be signed by a not risk adjusted against another issuer and second validation auditor with all qualified provider who is licensed by in the State risk pool in the applicable relevant source enrollment the State to diagnose mental illness and, benefit year. Therefore, we proposed to documentation, all claims and to the extent permissible under change the sampling methodology so encounter data, and medical record governing privacy and confidentiality that, beginning with the 2017 benefit laws, to contain: (i) The enrollee’s name; 28 27 For the 2018 and future benefit years, HHS (ii) sex; (iii) date of birth; (iv) current 26 The proposed rule described the sampling would not require the sole issuer in the State methodology incorrectly by stating that the sample market risk pool to include high-cost risk pool 28 For purposes of consistency, we made a would include 200 enrollees per issuer for each risk enrollees in its sample for data validation, as these technical revision to the name of this data element pool in which the issuer participates, instead of 200 payments will be subject to a separate audit to ‘‘sex’’ in the final rule, rather than ‘‘gender’’ as enrollees per issuer across risk pools. process. Continued

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status of all mental or behavioral health explained in the proposed rule that we data collection, and engage in a separate diagnoses; and (v) dates of service. We also believed that the proposal supports solicitation of input from stakeholders noted that ‘‘psychotherapy notes,’’ a the integrity of the risk adjustment data on this topic. subset of mental and behavioral health validation program by ensuring that an Response: Since we only have final information that receives special initial validation auditor obtains data results from the first pilot year of risk protections under the HIPAA Privacy that will enable proper validation of adjustment data validation thus far, we Rule, are not required for the purposes mental or behavioral health HCCs, do not currently have adequate of risk adjustment data validation.29 We which are susceptible to discretionary experience to be able to determine also noted that some State and Federal coding. Furthermore, we noted our whether failure rates for mental health privacy laws require that providers belief that the flexibility to use mental diagnoses are higher than other obtain patient consent before disclosing or behavioral health assessments would diagnoses, and whether those failure mental or behavioral health records, and minimize the burden on providers of rates are consistent by State. The policy that these consent requirements may complying with this requirement for error rate payment adjustments apply to mental or behavioral health because providers may be able to utilize finalized in this rule mitigates the assessments. We clarified that we do not records they routinely prepare and may potential for punitive payment view a State or Federal law requiring already have, as opposed to preparing adjustments, because only issuers with patient consent as inconsistent with the special summaries solely for the statistically meaningful failure rates will risk adjustment data validation purpose of risk adjustment data receive risk score error rates resulting in requirements to furnish a mental or validation. payment transfer adjustments.30 We will behavioral health record or assessment. Based on our review of the comments continue to evaluate whether additional Additionally, we noted that certain we received, we are generally finalizing relief is necessary, based on analysis of substance use disorder patient records the amendments to § 153.630(b)(6) to risk adjustment data validation results. are subject to the Federal confidentiality permit providers that are prohibited by Our policy to permit the use of mental law at 42 U.S.C. 290dd–2 and the State law from furnishing a full mental or behavioral health assessments by regulations issued thereunder in 42 CFR or behavioral health record to submit an providers that are prohibited by State part 2 and certain State laws, and assessment instead. We are making one law from furnishing a full record is generally require consent prior to clarification to convey that this intended to offer broadly applicable disclosure. We stated that we believed flexibility will not apply to providers relief and flexibility to account for the that this proposal is consistent with the that are prohibited solely by Federal law variation in privacy laws in particular foregoing Federal and State from furnishing a full mental or States. Therefore, we do not intend to confidentiality rules, and that the behavioral health record. We recognize solicit input on or otherwise engage in substance use disorder confidentiality that other State and Federal laws, an evaluation of State-specific requirements should govern when including the Federal confidentiality requirements. applicable. Therefore, issuers or law at 42 U.S.C. 290dd–2 and associated Comment: Two commenters providers may be required to obtain regulations that govern certain patient expressed concern that initial validation written patient consent to comply with substance use disorder records auditors may interpret or utilize mental this proposal. potentially apply to mental or or behavioral health assessments We noted the proposal would allow behavioral health assessments, and differently, and requested that HHS issuers an additional avenue to achieve would require a provider to obtain provide guidance or training to ensure compliance by permitting abbreviated enrollee consent before disclosing the consistent interpretation of the mental or behavioral health assessments assessment if applicable. We reiterate assessments. for risk adjustment data validation in that the proposal on mental or Response: We agree that consistent the event that a provider is subject to behavioral health assessments was not interpretation and utilization of mental State or Federal privacy laws that intended to provide an exception to any and behavioral health assessments is prohibit the provider from providing a applicable enrollee consent requirement important, and seek to encourage it. For complete mental or behavioral health under State or Federal law. purposes of risk adjustment data record to HHS. Under the proposal, to Comment: Most commenters validation, the assessment is limited to submit a mental or behavioral health supported the proposal. These the five discrete elements specified in assessment instead of the full mental or commenters stated that the proposal § 153.630(b)(6), most of which are behavioral health record, a provider would reduce burden, ensure straightforward, so HHS does not would be required to attest that relevant compliance with privacy rules, and anticipate a material risk of disparate State or Federal privacy laws prohibit assist with the chart retrieval process. interpretation or utilization of mental or him or her from providing the complete Others supported the proposal with behavioral health assessments by initial mental or behavioral health record. We certain modifications. For example, one validation auditors. HHS continues to commenter requested a safe harbor if work to leverage existing provider was specified in the proposed rule. HHS uses the mental health diagnosis failure, or error networks and communication channels data element of sex, as biologically determined, to rates, are high due to noncompliance to educate providers on the HHS- calculate enrollees’ risk scores under the PPACA from mental health providers. Similarly, risk adjustment program. operated risk adjustment data validation another commenter requested that HHS 29 ‘‘Psychotherapy notes’’ are notes recorded by a requirements. health care provider who is a mental health avoid punitive payment adjustments for Comment: One commenter requested professional documenting or analyzing the contents issuers whose production of records is of conversation during a private counseling session, the extension of flexibility to the actual constrained by compliance with State submission of documentation regarding or a group, joint, or family counseling session and law. The commenter also requested that that are separated from the rest of the individual’s treatment for mental or behavioral medical record. Psychotherapy notes do not include HHS acknowledge the existence of health conditions, expressing concern medication prescription and monitoring, counseling varying State-specific limitations on that there may not be an affected session start and stop times, modalities and consent for disclosure of mental or frequency of treatment, test results, and summaries of diagnoses, functional status, treatment plan, behavioral health records, evaluate the 30 Please see the above preamble section on symptoms, prognosis, and progress to date. See extent to which State-specific rules can ‘‘Payment Adjustments for Error Rates’’ for more § 164.501. be appropriately incorporated into the information.

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underlying record to identify in the first HHS does not intend to limit or restrictive than, the HIPAA regulations, instance. The commenter also requested otherwise affect the application of any and may require that providers obtain additional information regarding who such consent requirements under State patient consent before disclosing mental bears responsibility for preparation of or Federal law, which provide or behavioral health records or the mental or behavioral health important protections to enrollees. assessments. We do not view the risk assessment and how it differs from a full HHS recognizes, however, that our adjustment data validation requirements record. policy to allow providers to furnish a to furnish a mental or behavioral health Response: The provider is responsible mental or behavioral health assessment record or assessment as inconsistent for preparing the mental or behavioral may impose a slight increase in the with these consent requirements or health assessment, and the assessment burden of compliance with risk involving any ‘‘waiver’’ of enrollee is limited to the five elements specified adjustment data validation requirements privacy rights. in § 153.630(b)(6). When being used for because the assessment must be As discussed in the 2018 Payment risk adjustment data validation accompanied by an attestation from the Notice, in specific instances, risk purposes, it should be accompanied by provider. Attestations are necessary to adjustment permits the use of the provider’s signature and an demonstrate that the provider is prescription drugs to impute diagnoses. attestation that State privacy laws prohibited from furnishing the complete As noted elsewhere in this rule, HHS prohibit the provider from furnishing a medical record by State privacy laws, will continue to evaluate the inclusion complete medical record. This policy but we do not expect compliance with of additional prescription drug classes provides flexibility in cases where the the attestation requirement to be in the risk adjustment model, including State law prevents submission of the difficult. mental or behavioral health treatments, full record, but that flexibility does not As noted above, HHS does not intend to potentially impute missing diagnoses extend to the provision of any to exempt providers from any other for future benefit years. documentation regarding mental or applicable consent requirements under Comment: One commenter requested behavioral health conditions. HCCs State or Federal law, and we do not yet that HHS provide issuers flexibility to without adequate documentation, have adequate experience as to whether develop standard language requiring the whether through a full record or a failure rates will be higher for mental provider’s signature to ease the mental or behavioral health assessment, health conditions or substance use administrative burden of creating would result in an error. disorders. We reiterate that only issuers mental or behavioral health Comment: Several commenters did with statistically meaningful failure assessments. not support the proposal. For example, rates will receive risk score error rates Response: The approach being one commenter indicated that this and subsequent payment transfer finalized in this rule does not prevent policy of permitting mental or adjustments pursuant to the policy an issuer from developing standard behavioral health assessments would finalized in this rule.31 We will analyze language for the provider attestation if not significantly reduce burden, and risk adjustment data validation results the issuer believes it will help providers generally objected to the other State or to evaluate the impact of this policy on furnish mental or behavioral health Federal laws that may require the error rates, and will consider whether assessments and other required provider to obtain patient consent, further refinements are appropriate. documentation for risk adjustment data indicating that doing so may not be Comment: Commenters expressed validation purposes. possible. One commenter stated that concern that enrollees could be waiving Comment: Some commenters requiring provider attestation or patient their HIPAA rights if their providers expressed concerns about the Federal consent will add burden and reduce the furnish medical records that include rules governing confidentiality of likelihood of mental or behavioral enrollees’ diagnoses for risk adjustment substance use disorder patient records health records being furnished by data validation. The commenter under 42 CFR part 2, or their alignment issuers in risk adjustment data suggested that if a diagnosis can be with the HIPAA Privacy Rule. validation. The commenter also imputed by the presence of a Response: The comments on the expressed concern that there will likely prescription drug, HHS should include Federal rules governing confidentiality be higher error rates for HCCs related to treatments for mental illness as a drug of substance use disorder patient mental health or substance use class in the risk adjustment models, to records under 42 CFR part 2 and the disorders. impute diagnoses for which a medical HIPAA Privacy Rule concern Response: HHS believes that the record cannot easily be obtained. regulations that are implemented and finalized policy to permit the use of Response: As noted above and in the enforced by other agencies within HHS, existing mental or behavioral health proposed rule, we believe that section the Substance Abuse and Mental Health assessments affords flexibility to 1343 of the PPACA and associated Services Administration and the Office providers to use an alternative source regulations require issuers of risk for Civil Rights, respectively. Although for the documentation that otherwise adjustment covered plans to furnish any we appreciate these comments, we are would be necessary under risk records needed for purposes of the risk not able to address them in this adjustment data validation to maintain adjustment program, including mental rulemaking. the integrity of the risk adjustment and behavioral health records. The vii. Inter-Rater Reliability Rates program while complying with State HIPAA Privacy Rule generally permits Under § 153.630(b)(8), the initial and Federal privacy requirements. As disclosures that are required by law (see validation auditor must measure and discussed previously in this section and 45 CFR 164.512(a)). We recognize that report to the issuer and HHS, in a in the proposed rule, State and Federal some State and Federal privacy laws manner and timeframe specified by privacy requirements may impose requirements for mental and HHS, its inter-rater reliability rates independently require a provider to behavioral health information that are among its reviewers. An initial obtain patient consent in order to different from, and potentially more furnish a mental or behavioral health validation auditor must achieve a assessment. In providing the flexibility 31 Please see the above preamble section on consistency measure of at least 95 to submit assessments for risk ‘‘Payment Adjustments for Error Rates’’ for more percent for his or her review outcomes, adjustment data validation purposes, information. except for the initial benefit years of risk

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adjustment data validation, for which impose CMPs in accordance with the we believe this additional authority is the initial validation auditor may meet procedures set forth in § 156.805(b) necessary in light of the policies an inter-rater reliability standard of 85 through (e). We note that § 153.630(b)(9) finalized in the 2018 Payment Notice, percent. Consistent with our decision to already addresses the possible specifically, the concerns HHS make the 2016 benefit year another pilot imposition of CMPs for (1) and (2) highlighted around gaming and the year as referenced above, we proposed above, and provides a cross-reference to inclusion of prescription drug data in to amend § 153.630(b)(8) to add the § 156.805, which contains the bases and the risk adjustment model. We are 2016 benefit year as an initial year of procedures for imposing CMPs for (3) finalizing as proposed the amendments risk adjustment data validation for and (4) above. Section 153.630(b)(9) to § 153.630(b)(9) to clarify and which the initial validation auditor may provides the authority to assess CMPs strengthen HHS’s CMP authority. We meet the lower inter-rater reliability on all issuers of risk adjustment covered also clarify that HHS would not impose standard of 85 percent. We are finalizing plans, not just issuers on an FFE as does a CMP under § 153.630(b)(9) for a the amendment to § 153.630(b)(8) as § 156.805.32 We clarified that the benefit year on an issuer that is not proposed. proposal to impose CMPs for (3) and (4) required to submit an initial validation Comment: All commenters supported would apply to all issuers of risk audit for risk adjustment data validation the addition of the 2016 benefit year as adjustment covered plans, not just those for that benefit year. an initial year of risk adjustment data issuers on an FFE. We noted that the Comment: Most of the comments validation for which the initial CMP authority would be in addition to received supported the proposal. One validation auditor may meet an inter- HHS’s ability to adjust an issuer’s commenter requested definitions for rater reliability standard of 85 percent. transfers under § 153.350(c). misconduct, substantial noncompliance, One commenter noted that permitting As previously noted in the Second and reckless misrepresentation, along the 85 percent standard for another year 2013 Program Integrity Rule, and in the with examples for each case under would allow issuers to gain an 2015 Payment Notice, we proposed that which an issuer could receive a CMP. additional year of experience and HHS’s possible application of CMPs Response: The terms misconduct, process improvement before the would continue to take into account the substantial noncompliance, and reckless standard is increased. totality of the issuer’s circumstances, misrepresentation are incorporated from Response: We agree with commenters including such factors as an issuer’s § 156.805(a)(1) and (5). Examples of and are finalizing the amendment to previous record of non-compliance (if issuer misconduct that could warrant § 153.630(b)(8) as proposed. any), the frequency and level of the imposition of a CMP under the amended § 153.630(b)(9) include knowingly viii. Civil Money Penalties violation, and any aggravating or mitigating circumstances. Additionally, hiring an initial validation auditor who An effective risk adjustment data we would continue to impose any CMPs has conflicts of interest, or failing to validation program is essential to the so that the level of the enforcement ensure confidentiality and security of proper functioning of the HHS-operated action is proportional to the level of the data transmitted to the initial validation risk adjustment program. In order to violation. While we reserved the right to auditor or second validation auditors. enforce risk adjustment data validation impose penalties up to the maximum Examples of substantial noncompliance standards when operating risk amounts set forth in § 156.805(c), as a include unreasonable delays in adjustment data validation on behalf of general principle, we explained that we providing complete enrollment a State, we proposed to clarify and intend to work collaboratively with documentation, claims and encounter amend the bases upon which HHS may issuers to address any problems in data, or medical records documentation impose CMPs for violations of risk conducting the risk adjustment data to an auditor, or failing to properly adjustment data validation validation process. oversee an initial validation auditor. requirements. We believe this additional CMP However, the determination of whether To give HHS additional flexibility for authority will improve program conduct rises to the level of any of these ensuring compliance with the risk integrity and fairness by permitting HHS terms in any specific case is highly fact adjustment data validation requirements the authority to assess CMPs on issuers sensitive, involving consideration of any and in light of our experience in the first that engage in misconduct in risk mitigating or aggravating factors. pilot year of the risk adjustment data adjustment data validation. Although ix. Adjustment of Risk Adjustment validation program, HHS proposed to § 153.630(e) permits HHS to adjust Transfers Due to Submission of amend § 153.630(b)(9) to give HHS the payments and charges for issuers that do Incorrect Data authority to impose a CMP on an issuer not comply with audit requirements and of a risk adjustment covered plan in the standards, this provision only makes the On September 2, 2015, HHS released event of misconduct or substantial non- markets whole in the event of a the Adjustment of Risk Adjustment compliance with the risk adjustment violation of the risk adjustment data Transfers Due to Submission of data validation standards and validation standards or misconduct. We Incorrect Data guidance,33 describing requirements. Specifically, we proposed do not believe this provision provides a the process by which HHS addresses to amend § 153.630(b)(9) to state that, if sufficient deterrent effect to ensure instances of materially incorrect EDGE an issuer of a risk adjustment covered program integrity of the risk adjustment server data submissions. We reiterated plan (1) fails to engage an initial data validation program. Additionally, this guidance on November 3, 2017, validation auditor; (2) fails to submit the through the release of Evaluation of results of an initial validation audit to 32 Pursuant to § 153.20, risk adjustment covered EDGE Data Submissions for the 2017 HHS; (3) engages in misconduct or plan means, for the purpose of the risk adjustment Benefit Year.34 We proposed to include program, any health insurance coverage offered in risk adjustment data validation as a substantial non-compliance with the the individual or small group market with the risk adjustment data validation exception of grandfathered health plans, group standards and requirements applicable health insurance coverage described in 45 CFR 33 Available at https://www.cms.gov/CCIIO/ to issuers of risk adjustment covered 146.145(c), individual health insurance coverage Resources/Regulations-and-Guidance/Downloads/ described in 45 CFR 148.220, and any plan RA-Adjustment-Guidance-9-2-15.pdf. plans; or (4) intentionally or recklessly determined not to be a risk adjustment covered plan 34 Available at https://www.cms.gov/CCIIO/ misrepresents or falsifies information in the applicable Federally certified risk adjustment Resources/Regulations-and-Guidance/Downloads/ that it furnishes to HHS, HHS may methodology. EDGE-Submissions-2017.pdf.

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method of discovering materially adjustment program efficiently, while effect on the transfer formula, error rate, incorrect EDGE server data submissions ensuring that issuers do not profit from or both amounts will depend on the and making adjustments pursuant to their data submission errors or harm specifics of the error. For example, if an § 153.630(e), as described in the their competitors in the relevant market. error affects premiums alone, only the September 2, 2015 guidance.35 We We sought comment on this proposal. Statewide average premium would need proposed that demographic or We are finalizing this policy as to be adjusted. HHS intends to be in enrollment errors discovered during risk proposed. communication with affected issuers adjustment data validation would be the Comment: Commenters supported the throughout the second validation audit basis for an adjustment to the applicable proposal, or agreed with it but requested process, and to resolve potential benefit year transfer amount, rather than additional clarification. For example, discrepancies in a manner similar to the the subsequent benefit year risk score. one commenter requested examples of EDGE data submission discrepancy The elements being validated are related materially incorrect data submissions. process. to the transfer formula and demographic Another commenter sought clarification on certain technical issues related to the h. Risk Adjustment User Fee for the variables in the risk adjustment models. 2019 Benefit Year (§ 153.610(f)) We explained that we believe the proposal, including the definition of process of identifying demographic and demographic and enrollment data As noted above, if a State is not enrollment errors is substantially errors, whether these errors will impact approved to operate, or chooses to forgo similar to a discrepancy in the transfer elements of the transfer formula, the operating its own risk adjustment formula, which is addressed in the error rate, or both, and the timing of any program, HHS will operate risk current benefit year as part of the EDGE adjustments that HHS would make with adjustment on its behalf. In 2019, HHS data discrepancy process under respect to current year risk adjustment will be operating a risk adjustment § 153.710, as opposed to a discrepancy transfer amounts and related data program in every State. As described in in underlying enrollee diagnoses transfer element errors. One commenter the 2014 Payment Notice, HHS’s contributing to risk scores, which is supported HHS’s current approach of operation of risk adjustment on behalf of addressed through subsequent year risk taking a subsample of 50 enrollees to States is funded through a risk score adjustments as part of risk verify demographic and enrollment adjustment user fee. Section adjustment data validation. information, but stressed that the 153.610(f)(2) provides that an issuer of An overstatement or understatement subsample results should not be the sole a risk adjustment covered plan must of premium data may affect issuers basis for applying current year transfer remit a user fee to HHS equal to the product of its monthly billable member differently, because it will lead to an adjustments. Rather, if errors are enrollment in the plan and the per increase or decrease in the absolute identified from the subsample, HHS member per month risk adjustment user value of the magnitude of the risk should then investigate the issuer’s data further to assess if there were materially fee specified in the annual HHS notice adjustment transfers (and will affect the incorrect EDGE data submissions. of benefit and payment parameters for calculation of the geographic rating area Response: We clarify that significant the applicable benefit year. factors). Therefore, an issuer’s errors found in the risk adjustment data OMB Circular No. A–25R established submission of incorrect EDGE server validation demographic and enrollment Federal policy regarding user fees, and premium data may have the effect of subsample review will result in specified that a user charge will be increasing or decreasing the magnitude communications from HHS to the issuer assessed against each identifiable of risk adjustment transfers to other regarding the issuer’s underlying data recipient for special benefits derived issuers in the market, depending on the before the potential application of any from Federal activities beyond those direction of the premium error, holding adjustments to risk adjustment transfers. received by the general public. The risk constant the other elements of the The demographic and enrollment data adjustment program will provide special payment transfer formula. In cases elements collected for purposes of risk benefits as defined in section 6(a)(1)(B) where there is a material impact on risk adjustment are date of birth, sex, plan of Circular No. A–25R to issuers of risk adjustment transfers for that particular identifier, enrollment start and end adjustment covered plans because it market as a result of incorrect EDGE dates, premium amount, and rating area. mitigates the financial instability server premium data, HHS would In addition to the issues described associated with potential adverse risk calculate the dollar value of differences above regarding incorrect premium, selection. The risk adjustment program in risk adjustment transfers, and, where certain demographic or enrollment also contributes to consumer confidence the difference is detrimental to one or errors could indicate the presence of in the health insurance industry by more issuers in the market, adjust the larger issues such as assignment of helping to stabilize premiums across the other issuers’ risk adjustment transfer enrollees to the incorrect model or metal individual and small group markets. amount by that calculation, and increase level, which would lead to incorrect risk In the 2018 Payment Notice, we the risk adjustment charge (or decrease scores and a miscalculation of the AVs calculated the Federal administrative the risk adjustment payment) to the and induced demand factors (IDF) in the expenses of operating the risk issuer that made the data error, in order transfer formula, or incorrect age factors. adjustment program for the 2018 benefit to balance the market.36 We explained If this occurs, we would initiate a year to result in a risk adjustment user that we believe this approach would separate process outside of risk fee rate of $1.68 per billable member per allow HHS to operate the risk adjustment data validation to further year or $0.14 PMPM, based on our evaluate the impact of the incorrect data estimated contract costs for risk 35 This guidance is also included in the submission, determine whether the adjustment operations and estimates of Evaluation of EDGE Data Submissions for the 2017 Benefit Year, released on November 3, 2017, market needs to be made whole due to billable member months for individuals available at https://www.cms.gov/CCIIO/Resources/ the errors, and then make the necessary enrolled in a risk adjustment covered Regulations-and-Guidance/Downloads/EDGE- adjustments to affected issuers. plan. For the 2019 benefit year, we Submissions-2017.pdf. Therefore, HHS will not be relying proposed to use the same methodology 36 Calculation of the dollar value will include adjustment to the Statewide premium average and, solely on subsample results as the basis to estimate our administrative expenses to the extent possible, adjustment to the geographic for applying current year transfer to operate the program. These contract cost factor. adjustments. Whether an error has an costs cover development of the model

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and methodology, collections, other forms of individual health 2. Rate Increases Subject to Review payments, account management, data insurance coverage.37 (§ 154.200) collection, data validation, program States have allowed rating practices Section 2794(a)(1) of the PHS Act integrity and audit functions, for student health insurance coverage to requires the Secretary, in conjunction operational and fraud analytics, be more in line with large group pricing, with States, to establish a process for the stakeholder training, and operational in which experience rating and other annual review of unreasonable premium support. To calculate the user fee, we factors can be used to determine rates. increases for health insurance coverage. divided HHS’s projected total costs for Because student health insurance Section 2794(a)(2) of the PHS Act administering the risk adjustment coverage is typically experience rated, requires health insurance issuers to programs on behalf of States by the and is typically only available to submit to the Secretary and relevant expected number of billable member students and their dependents with an State a justification for an unreasonable months in risk adjustment covered open enrollment period coinciding with premium increase prior to plans in HHS-operated risk adjustment the start of the academic year, it is implementation. States may establish a States for the benefit year. exempt from single risk pool rating more robust review process, and many requirements and not guaranteed to be have. We previously estimated that the total available or renewable to individuals cost for HHS to operate the risk Section 154.200(a)(1) currently who are not students or dependents of provides that a rate increase for single adjustment program on behalf of States students in an institution of higher risk pool coverage beginning on or after for 2019 will be approximately $38 education. We are finalizing the January 1, 2017 is subject to a million, and the risk adjustment user fee exemption as proposed, except that we reasonableness review if: (1) The would be $1.68 per billable member per are modifying the applicability date to average increase, including premium year, or $0.14 PMPM. However, we now align with the timing of when student rating factors described in § 147.102, for estimate the cost for HHS to operate the health insurance coverage typically all enrollees, weighted by premium risk adjustment program on behalf of begins, such that the exemption will be volume for any plan within the product, States for the 2019 benefit year to be effective for student health rate filings meets or exceeds 10 percent; or (2) the approximately $40 million, and are for the next plan year. This change, increase exceeds a State-specific finalizing a risk adjustment user fee of effective for student health insurance threshold approved by the Secretary. $1.80 per billable member per year, or coverage effective on or after July 1, We proposed to amend this provision to $0.15 PMPM, to take account of eligible 2018, will reduce the regulatory burden establish a 15 percent default threshold administrative and personnel costs on States and issuers of student health for reasonableness review, in related to the operation of the HHS- insurance plans. recognition of significant rate increases operated risk adjustment program that Comment: Most commenters in the past number of years, rather than were previously excluded from the supported the proposal to exempt the current 10 percent default estimate. student health insurance coverage from threshold.38 Federal rate review requirements. Section 154.200(a)(2) currently C. Part 154—Health Insurance Issuer Commenters suggested that the requires States to submit a proposal to Rate Increases: Disclosure and Review exemption should apply to coverage the Secretary for approval of any State- Requirements effective on or after July 1, 2018, to specific threshold. We proposed to 1. Applicability (§ 154.103) coincide with the traditional school amend § 154.200(a)(2) to require year. Some commenters expressed submission of a proposal only if the Since July 18, 2011, issuers have been concern that exempting student health State-specific threshold is higher than required to submit rate filing insurance coverage would result in the Federal default threshold. We justifications for rate increases for non- minimal oversight and decreased proposed this change to reduce burden grandfathered plans in the individual affordability. and promote State flexibility. and small group markets. This Response: We are finalizing the We also proposed to delete paragraph requirement was established, in part, to exemption and it will apply to student (b) in its entirety. That paragraph carry out the Secretary’s responsibility, health insurance coverage, as defined in currently requires that the Secretary in conjunction with States, under § 147.145, with an effective date on or publish a notice each year indicating section 2794(b)(2)(A) of the PHS Act to after July 1, 2018. We note that States which threshold applies to each State. monitor premium increases of health maintain the flexibility to review rate For States that request a State-specific insurance coverage offered through an increases of any size and any other threshold above what is set by CMS, Exchange and outside of an Exchange. aspects of student health insurance CMS noted it would continue to post Student health insurance coverage is coverage. In States that do not have an information on its website beginning considered by HHS to be a type of Effective Rate Review Program, we will with requests submitted on or after individual market coverage and is continue to monitor the compliance of January 1, 2019. generally subject to the PHS Act student health insurance coverage with We proposed to redesignate paragraph individual market requirements, which applicable market rating reforms based (c) as paragraph (b) and revise that paragraph to delete the language related has included rate review. We proposed on complaints and as part of targeted to modify § 154.103(b) to exempt market conduct examinations. In States where we are enforcing market reforms, 38 The 10 percent threshold was established in the student health insurance coverage from ‘‘Rate Increase Disclosure and Review’’ Final rule the Federal rate review requirements, we will continue to review form filings (76 FR 29963, May 23, 2011) based upon three effective for plan or policy years for student health insurance coverage indices. These indices are: (1) The medical beginning on or after January 1, 2019. for compliance with applicable PHS Act component of the Consumer Price Index (CPI); (2) individual market requirements. the Expenditure data (NHE); and As we discussed in the proposed rule, (3) the Standard and Poor’s Healthcare Economic and as commenters noted, student Commercial Index. The threshold was finalized at health insurance coverage is generally 37 See preamble discussion in the final rule, 10 percent based on the analysis of the trend in ‘‘Health Insurance Market Rules; Rate Review’’ 78 health care costs and rate increases provided in the rated and administered differently from FR 13406, 13424 (February 27, 2013). preamble to the proposed rule.

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to rates filed for coverage beginning believe this change will normalize 3. Submission of Rate Filing before January 1, 2017, currently excessive increases. Justification (§ 154.215) We are not lowering the threshold to captured in paragraph (c)(1) as this Section 154.215(h)(2) includes a 39 6 percent, as doing so may increase the provision is no longer necessary. We reference to 45 CFR 5.65, which defined burden on issuers and States. We are not proposed to redesignate paragraph (d) as trade secret and confidential establishing two thresholds (one at the paragraph (c). Finally, we proposed commercial or financial information product level and one at the plan level). conforming changes to update the cross under HHS regulations implementing When determining whether an increase references in § 154.200 to align with the the Freedom of Information Act, 5 is subject to review, rate increases are changes described above. U.S.C. 552. HHS revised 45 CFR part 5 We are finalizing these changes as calculated at the plan level. That ensures that a plan that experiences a in a final rule issued on October 28, proposed with one modification, 2016, effective on November 28, 2016 described below. These changes will significant rate increase does not avoid review simply because the average (81 FR 74930). We proposed to make a apply to single risk pool rate filings technical correction to § 154.215(h)(2) to submitted by issuers for plan or policy increase for the product did not meet or exceed the applicable threshold. refer to 45 CFR 5.31(d) because 45 CFR years beginning on or after January 1, 5.65 no longer exists and § 5.31(d) now 2019. Because consumers are affected by rate increases at the plan level, we believe lists the reasons a record may be Comment: Some commenters withheld. We are finalizing the change supported a threshold increase, noting that increases for the plan, not the product, should continue to be the as proposed. that raising the threshold to 15 percent trigger for determining whether an Comment: Some commenters opposed would allow regulators to focus their increase is subject to review. CMS’s use of the Freedom of attention on higher rate increases and We expect the change to have a Information Act and requested issuer reduce the regulatory burden for both minimal impact on transparency. All information be provided without any States and issuers. Other commenters issuers must continue to submit a redaction. supported raising the threshold, but did Uniform Rate Review Template (URRT) Response: We proposed and are not specify an alternative to 10 percent. (Part I of the Rate Filing Justification) for finalizing a technical correction to the Many commenters opposed changing all single risk pool plan submissions. regulatory reference. We did not the reasonableness review threshold to Issuers offering a QHP or any single risk propose any change to our 15 percent, concerned that the change pool submission containing a rate interpretation of a trade secret and may normalize excessive increases. increase of any size must continue to confidential commercial or financial Other commenters opposed the change submit an actuarial memorandum (Part information. The issuer may submit a because it would negatively affect III of the Rate Filing Justification). We redacted actuarial memorandum, but transparency of rate setting, noting that are finalizing the proposal to change the CMS does not make any redaction the Consumer Justification Narrative Federal default review threshold to 15 beyond what is submitted in the rate (Part II of the Rate Filing Justification) percent beginning with single risk pool filing. is only required for increases that meet rate filings submitted by issuers for plan or exceed the review threshold. Some 4. Timing of Providing the Rate Filing or policy years beginning on or after Justification (§ 154.220) commenters suggested a 6 percent January 1, 2019. threshold would be appropriate because Comment: Some commenters opposed Section 154.220(b) provides that a that would be in line with health CMS requiring submission of a proposal health insurance issuer must submit expenditures and still above the general (and posting of that proposal) only if the applicable sections of the Rate Filing rate of inflation. A few commenters State-specific threshold is higher than Justification for all single risk pool suggested there should be a 15 percent the Federal default threshold. coverage in the individual or small threshold at the product level and 20 Response: The Federal review group market by the earlier of (1) the percent threshold at the plan level. threshold is a minimum standard. States date by which the State requires Response: We note that the threshold are able to apply a stricter standard, and submission of a rate filing; or (2) the set by HHS constitutes a minimum many already do. Because States that date specified in guidance by the standard. By increasing the threshold apply a lower threshold meet the Secretary. We have interpreted that trigger to 15 percent, we are providing Federal minimum standard, we do not section to require submission of all rate an opportunity for States to reduce their believe it is necessary or appropriate to filings, for both QHPs and non-QHPs, at review burden, although most States require those States to submit a proposal a uniform time.40 We proposed to allow currently employ stricter rate review to CMS. Therefore, we are finalizing the a State to set a later submission deadline standards and may continue to do so. proposed changes to § 154.200(a)(2) for issuers who offer non-QHPs only, Additionally, increasing the Federal with the following modification: We starting with the 2019 plan year. We are default threshold for review will reduce added language to clarify that these finalizing the change as proposed. burden for issuers. After an analysis of State proposals must be submitted in Comment: Some commenters all rates subject to review that were the form and manner specified by the expressed concern that the proposal determined to be ‘‘unreasonable’’ since Secretary. CMS will only require a provides an advantage to issuers the inception of the review threshold, proposal from States requesting a higher offering only non-QHPs and may only one filing with this determination threshold. States that impose stricter provide an opportunity for competitors has fallen between the 10 to 15 percent standards will communicate those to shadow price. Many commenters range. For these reasons, we do not standards to their issuers as they supported the proposal, in order to currently do with many other aspects of reduce State burden. 39 This standard (that is, the average increase for State-specific requirements. CMS will Response: We are finalizing the all enrollees weighted by premium volume meets or post information from States that proposal. We remind issuers that offer exceeds the applicable threshold), however, request a threshold higher than 15 both QHPs and non-QHPs in a market continues to apply to rates filed for coverage beginning before January 1, 2017, including with percent and will issue further guidance in a given State to submit its rate filing respect to compliance reviews and enforcement on the process for submission and actions. review of such State requests. 40 80 FR 10782.

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in accordance with the deadlines are finalizing the proposal. This change § 154.301(b)(1)(i) and (ii) is made established for QHPs to support will reduce the amount of time prior to available to the public at a uniform time regulatory review of compliance with posting that the State must notify CMS, for all proposed and final rate increases, the single risk pool requirement. but does not reduce the public comment as applicable, in the relevant market Establishing a later submission deadline period. segment and without regard to whether for issuers that offer only non-QHPs is b. Posting of Rate Increases coverage is offered on or off of an a State option, not a requirement. We Exchange. believe it will reduce burden while Section 154.301(b)(3) provides that a D. Part 155—Exchange Establishment empowering States to pick the State with an Effective Rate Review Standards and Other Related Standards timeframe that works best for their Program must ensure that information Under the Affordable Care Act markets, and also accounts for market regarding rate increases is made differences between States. We also available to the public at a uniform time 1. Standardized Options (§ 155.20) for all proposed and final rate increases, remind States and issuers that even if In the 2017 Payment Notice, HHS the submission deadlines differ; all as applicable, in the relevant market segment and without regard to whether introduced standardized options (also information must be submitted to CMS now referred to as Simple Choice plans). by the earlier of the State deadline or coverage is offered on or off of an Exchange. That provision was codified A standardized option is a QHP offered the Federal deadline. We also remind for sale through an individual market States and issuers that only submission in order to set a level playing field, to prevent issuers that submit rate filings Exchange that either has a standardized deadlines may vary; uniform posting cost-sharing structure specified by HHS will still be required, as discussed later from having an advantage over their competitors that submitted rate in rulemaking or has a standardized below, to help mitigate the potential for cost-sharing structure specified by HHS shadow pricing and other anti- filings earlier. We proposed to eliminate the in rulemaking that is modified only to competitive behaviors. requirement for uniform posting so that the extent necessary to align with the 5. Determinations of Effective Rate States that have an Effective Rate high deductible health plan (HDHP) Review Programs (§ 154.301) Review Program would have the option requirements under section 223 of the Code or the applicable annual limitation a. State Posting of Rate Increases to post proposed and final rate filing information on a rolling basis. We are on cost sharing and HHS actuarial value We proposed to modify not finalizing this proposal. requirements. For the 2017 and 2018 § 154.301(b)(2), by reducing the advance Comment: A few commenters benefit years, HHS specified notification required, so that a State supported the proposal, but the majority standardized options in rulemaking, with an Effective Rate Review Program of commenters opposed the proposal, encouraged issuers to offer such plans, must notify us in writing, no later than noting that uniform posting protects and provided differential display of 5 business days prior to the date it issuers from shadow pricing and these plans on HealthCare.gov. intends to make any proposed or final ensures a level playing field in a fair As noted in the proposed rule, we rate filing information public if the State competitive market. Those commenters seek to encourage free market principles will be posting prior to the date were also concerned that posting on a in the individual market, and to specified by the Secretary. We are rolling basis may promote manipulation maximize innovation by issuers in finalizing this change as proposed. by some market competitors, and could designing and offering a wide range of Comment: The majority of inadvertently contribute to market plans to consumers. We noted concerns commenters supported this proposal. destabilization. that providing differential display for Some commenters requested that CMS Response: We proposed to give States these plans may limit enrollment in require States to inform issuers prior to the option to post rate increase coverage with plan designs that do not posting. Some commenters requested information on a rolling basis in order match the standardized options, that CMS require States to post rate to accommodate a few States that have removing incentives for issuers to offer filing information on State websites laws requiring immediate posting upon coverage with innovative plan designs. even if the information is also posted on receipt. We did not receive We believe that encouraging innovation CMS’s website. Two commenters overwhelming support for that change, is especially important now, given the opposed the proposal because they as only two States supported it; the stresses faced by the individual market. interpreted the proposal as a reduction majority of commenters opposed the Therefore, we are finalizing our to the public’s opportunity to review change. We agree with commenters’ proposal to not specify any standardized and comment. concerns that removing the requirement options for the 2019 benefit year, and Response: We appreciate the for uniform posting could have not to provide differential display for importance of State communication unintended, negative effects on standardized options on with issuers, and we expect States to competition in the markets. Some HealthCare.gov. Agents, brokers, and maintain satisfactory communication commenters also feared that posting on issuers that assist consumers with QHP regarding posting deadlines to issuers, a rolling basis could cause confusion selection and enrollment as described in but decline to propose requirements among consumers, and eliminate the § 155.220(c)(3) and § 156.265(b), related to such. We also did not propose likelihood of consumers easily respectively, are also not required to and are not making changes to the comparing a rate increase across all provide differential display for requirements regarding States posting products. We do not want to provide standardized options on those third- on their own website. States are unfair advantages to issuers that file party websites. We are finalizing the permitted to use CMS’s website because later in the filing season, or contribute policies on standardized options as we are mindful of the burden and cost to consumer confusion. Therefore, we proposed. associated with such posting, but we are not finalizing the proposal. We are Comment: Many commenters encourage States to consider posting retaining § 154.301(b)(3) as it exists in supported the proposed policy to rate filing information directly on their our current regulations to require that a discontinue standardized options for the respective websites, while also State with an Effective Rate Review 2019 plan year. Commenters noted that providing a link to the CMS website. We Program ensure that the information in they believed standardized options

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stifled issuers’ ability to develop such as annual limitations on cost regarding recent enrollment in innovative plan designs. Commenters sharing and deductibles, previously standardized options could cause also noted that because of the specified as part of standardized options competitive harm to issuers, but intend differential display, issuers may have are mostly available to consumers in to continue to release historical offered and consumers may have FFEs. Therefore, we do not believe it is enrollment data for all QHPs, including purchased HHS-designed plans that did necessary to mandate or otherwise standardized options, in the future. not best meet consumers’ needs. Other further provide an incentive for issuers Commenter: A commenter noted that commenters noted that consumers may to offer plans that meet the standardized options assist States in have mistakenly thought that characteristics of standardized options. Federal and State review, certification, standardized options were superior to We agree with commenters that and oversight. other plans; and that other tools, such HealthCare.gov plan filters for other Response: States have previously been as AV, EHB, and other HealthCare.gov tools are sufficient to enable most able to complete QHP certification, plan filters were sufficient in assisting consumers to make plan selections. review, and oversight for issuers that are consumers in selecting and comparing However, we continue to explore not offering standardized options, and plans. Other commenters questioned the strategies to make shopping on therefore, we believe that they will be benefits of standardized options. HealthCare.gov as easy as possible, and able to continue doing so without Many other commenters supported to better support consumers in choosing relying on standardized options. HHS continuing to specify standardized coverage that is best for them. options, noting that they are a useful Consumers are able to select a QHP 2. General Standards Related to the consumer-support tool that aids in plan based on metal level, and are generally Establishment of an Exchange comparisons and selection and that offered coverage of a similar set of a. Flexibility for State Exchanges and withdrawing the standardized options essential health benefits. We agree with State Exchanges on the Federal Platform could create confusion for consumers, commenters that certain populations (§ 155.106 and § 155.200) especially those with low health literacy with specific health conditions may not While the PPACA allowed each State or certain health conditions. Others purchase a QHP that best meets their to operate its own State Exchange, noted that removing the standardized needs if they merely select based on a currently 11 States and the District of option designation could make plan standardized option designation. selection more difficult resulting in Standardized options offer simple plan Columbia operate their own Exchanges, fewer people enrolling in QHPs. comparisons at a high level to assess five States utilize the SBE–FP model, Some commenters noted that the comparability on cost sharing of certain and FFEs operate in the remaining 34 standardized cost sharing encourages services. However, consumers with States. We seek to support innovation issuers to innovate on other plan specific health conditions may be better by States operating State Exchanges by features and encourages issuers to served by a different QHP that provides providing opportunities for increased compete on networks and formularies. benefits better suited for their program flexibilities to help support the Other commenters noted that the individual needs. By removing retention and financial self- standardized plan designs ensure standardized options, we are mitigating sustainability of States that adopted the offerings had certain desirable features, the risk that consumers with special SBE model. In particular, we sought such as fewer specialty drug tiers and coverage needs choose a standardized comment on how HHS can best support first dollar coverage. Commenters noted option plan that may not provide the State Exchange efforts to utilize that standardized options were optimal mix of cost-sharing protections, commercial platform services, including voluntary and therefore could not stifle benefits, and networks for their what type of technical support would be innovation. Another commenter noted situation. We believe these benefits useful and what, if any, specific that removing standardized options outweigh any potential additional regulatory changes would facilitate the could result in issuers designing plans difficulty in selecting a QHP that could use of these services. specifically for a healthy population. result from the elimination of the We also proposed to explore strategies Another commenter supported making standardized option designation. to make the SBE–FP model more standardized options mandatory and For these reasons we are finalizing the appealing and viable to States with expanding to include SADPs. policy as proposed. FFEs, as well as to support retention of Response: As we noted in the Comment: One commenter requested existing SBE–FPs. As codified in the proposed rule, we believe that not clarification that if the proposal is 2017 Payment Notice, the SBE–FP specifying standardized options for the finalized as proposed standardized model allows States to establish the 2019 plan year will remove options would not appear on legal status of their Exchanges as State disincentives for issuers to offer HealthCare.gov or be designated in Exchanges while leveraging the coverage with innovative plan designs. public use files. Another commenter economies of scale available through the We agree that issuers are in the best requested that HHS release data related Federal eligibility and enrollment position to design and offer innovative to standardized options offerings and platform and information technology plan designs. We are similarly finalizing enrollment publicly prior to making a infrastructure. The SBE–FP model offers the removal of the differential display of decision about ceasing to specify States opportunities to retain more standardized options. standardized options. control over their Exchanges than if an As we noted in the 2017 Payment Response: The proposal is being FFE operated in the State, as it allows Notice final rule,41 we designed the finalized as proposed. Therefore them to control plan management and standardized options to be as similar as standardized options will not display as consumer assistance activities, without possible to the most popular (weighted ‘‘Simple Choice Plans’’ on the additional responsibility of building by enrollment) QHPs in the FFEs in HealthCare.gov, nor will information be the infrastructure required to operate an order to minimize market disruption collected and reported in public use information technology eligibility and and impact on premiums. Consequently, files for the 2019 benefit year. We have enrollment platform. Accordingly, we we believe that the plan design features, previously released data regarding seek to explore options for streamlining standardized options offerings in public current requirements and leveraging 41 81 FR at 12289 (March 8, 2016). use files. We believe releasing data private sector and Federal platform

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technologies and advances to increase Response: We appreciate the 2017 Payment Notice, States can elect to opportunities for those States interested comments, and will consider them as operate an individual market SBE–FP, in remaining or becoming SBE–FPs. We we continue to explore incentives and an SBE–FP for SHOP, or both. If a State also intend to continue to explore areas program flexibilities for the SBE and operates an SBE–FP for SHOP, the SBE– where current authority, technology, SBE–FP models. The SBE–FP model FP utilizes the Federal platform for and operational capacities would permit was intended to improve States’ ability enrollment, eligibility, and premium HHS to provide additional options in to operate efficient Exchanges by aggregation functions. operational functions to SBE–FPs and providing the option for State As discussed more fully in section provide SBE–FPs with a greater role in Exchanges to agree to rely on the III.D.9 of this final rule, we proposed decision-making. We sought comment Federal eligibility and enrollment changes to required SHOP functionality, on ways to strengthen and enhance the platform and information technology effective on the effective date of this SBE–FP model. infrastructure to carry out certain rule, for plan years beginning on or after Comment: Several commenters functions in order for the State to fulfill January 1, 2018, under which qualified supported further actions by HHS to requirements as a State Exchange. We employers and employees could enroll allow SBE–FPs greater access to continue to explore ways to make this in SHOP plans by working with a QHP enrollment data and consumer a more appealing option to States that issuer or SHOP-registered agent or assistance tools, and supported efforts to currently have FFEs. In 2017, at the broker. As a result of the finalization of customize the Federal platform to meet request of the SBE–FPs, we shared new these proposals, many Federal platform SBE–FP needs. Other commenters data with the SBE–FPs to enhance their functions currently available to a State encouraged HHS to lower or eliminate consumer outreach functions, customer operating an SBE–FP for SHOP will no the SBE–FP user fee, increase relationships, and fiscal planning longer exist, including employee predictability of the user fee, or to tailor activities. HHS intends to continue to eligibility, enrollment, and premium the user fee to an Exchange based on use enhance these data-sharing efforts with aggregation functions. Therefore, States of certain Federal platform options. One SBE–FPs to support their ability to operating an SBE–FP for SHOP will no commenter proposed HHS consider new fulfill their responsibilities. However, at longer be able to utilize the Federal Federal grant funding for State this time, HHS is unable to offer a menu platform for those functions. Exchanges to purchase commercial of Federal platform functionalities to an We proposed to amend § 155.106(c) to technology platforms, while others SBE–FP. Likewise, at this time, HHS is remove the option for States to seek requested HHS reduce market unable to offer State-specific approval to operate an SBE–FP for uncertainty and further streamline customization of the Federal platform SHOP after the effective date of this eligibility verification requirements to agreement, but will continue engaging rule, and are finalizing the policy as support the success of SBEs. Another with SBE–FPs to refine the agreement. proposed. Nonetheless, States that are commenter requested that HHS promote We also note that § 155.140 permits currently operating an SBE–FP for regional State Exchanges to mitigate States to participate in regional SHOP, which include Kentucky and financial sustainability challenges faced Exchanges spanning two or more States. Nevada, can choose to maintain their by smaller States. Several commenters This allows States interested in existing SBE–FPs for SHOP, using the encouraged the use of direct enrollment operating State Exchanges to partner Federal platform functionality that and enhanced direct enrollment with each other and leverage economies would remain, subject to the applicable capabilities and private and Federal of scale by sharing a common requirements in § 155.200(f)(4), which platform technologies by State information technology infrastructure or we are amending to align with the Exchanges and SBE–FPs. One platform, and HHS encourages States to changes to SHOP functionality commenter suggested State Exchanges explore this as an option. States that are requirements. Issuers in these SBE–FPs consolidate into a single entity utilizing interested in this option would need to for SHOP will continue to be subject to Federal platform technology while obtain HHS approval to operate as a § 156.350, which we are amending to enabling private partnerships and non- regional Exchange, fulfill the align with the changes to SHOP profit entities to perform consumer requirements under § 155.140, and meet functionality requirements. For those facing functions. Two commenters the functional requirements in 45 CFR issuers that offer SHOP QHPs in SBE– suggested the Federal platform include part 155 that are applicable to States FPs for SHOP beginning on or after functionality to support independent who wish to operate their own SBE. We January 1, 2018, the expected burden (as enrollment in dental plans in SBE–FPs. also note that HHS has provided the well as expected reduction in burden) Other commenters supported the authority and flexibility for SBEs to should be similar to that of issuers in concepts of innovation and increased utilize the direct enrollment pathway as the FF–SHOPs. customization of the Federal platform, an alternative option for enrolling Comment: One commenter suggested but suggested HHS prioritize consumers into SBEs. HHS continues to HHS should consider continuing to improvements to the overall encourage SBEs and SBE–FPs to explore permit States to elect to operate as an HealthCare.gov system infrastructure this option in the context of evaluating SBE–FP for SHOP, to increase the type before focusing on State-specific options that best suit the needs of their of Exchange models available to States. enhancements to HealthCare.gov. Some Exchange, State, and consumers. Otherwise, we did not receive commenters emphasized the need for substantive comments regarding the guardrails to protect patients and b. Election To Operate an Exchange proposed changes to § 155.106. consumers as HHS explores flexibilities After 2014 (§ 155.106) Response: As described above, as a and innovations in Exchange models. Section 155.106 describes the process result of the finalization of the SHOP One commenter expressed concern that for a State electing to operate a State proposals described in this rule, the HHS’s support for expanding the SBE– Exchange, terminating its State SHOP Federal platform currently FP model signaled an intent to reduce Exchange and transitioning to an FFE, available to a State operating an SBE–FP Federal support for small population or seeking to operate an SBE–FP. This for SHOP will essentially no longer States and requested assurance the FFE section applies to both individual exist, including the Federal platform would continue to be available for small market and SHOP Exchanges. Currently, functions of employee eligibility, States. under § 155.106(c), as finalized in the enrollment, and premium aggregation

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on which SBE–FPs for SHOP currently applies to § 156.110, and that the changing needs. These commenters rely. Therefore, States operating an proposed § 156.111, which offers States requested that HHS create a public SBE–FP for SHOP will no longer have the flexibility to select a new EHB- process for States to consider new State- an option to rely on the Federal benchmark plan, would not remove the required benefits as EHB without platform for those functions. We are obligations required with regard to additional cost to the State. Other finalizing the policy as proposed, with maximum allowed generosity for a commenters opposed requiring States to a minor, non-substantive change to the State’s EHB-benchmark plan. For further defray mandated benefits at all, because regulatory text. discussion of how the State mandate the policy discourages States from policy at § 155.170 would apply to EHB ensuring access to key health care c. Additional Required Benefits under the proposals at § 156.111 services for consumers—such as autism (§ 155.170) providing States with options to select and opioid dependency disorder Section 1311(d)(3)(B) of the PPACA a new EHB-benchmark plan for plan services. Several commenters supported permits a State, at its option, to require years beginning in 2020 and later, see the proposal to maintain the policies at QHPs to cover benefits in addition to the preamble to § 156.111. § 155.170, noting that section the EHB, but requires a State to make We sought comments on this 1302(b)(4)(H) of the PPACA grants the payments, either to the individual approach. Specifically, we were Secretary flexibility to update EHB enrollee or to the issuer on behalf of the interested in comments on different benefit categories as it becomes enrollee, to defray the cost of these applications of the State mandate policy necessary to do so. Other commenters additional State-required benefits. In to the proposed policy for EHB- believed that a stricter standard previous rulemaking, we directed States benchmark plan selections at § 156.111 regarding defrayal is needed to ensure to identify additional State-required that would increase State flexibility that States comply with the current benefits that are subject to defrayal and while also being cost effective for States, defrayal requirement at § 155.170, and provided direction on how QHP issuers consumers, and the Federal government, to ensure that a sufficient defrayal in a State must calculate the cost of such as an approach that would allow requirement is in place based on new those benefits.42 States the flexibility to update benefits State EHB-benchmark plan selection We made a number of proposals at mandated by State action prior to or on options at § 156.111. § 156.111 related to State changes to December 31, 2011, that are considered Response: We understand the EHB-benchmark plans beginning for the EHB, so long as the State can prove that importance of benefit mandates to States 2019 plan year. In light of those the update to the State mandate is under the policies described above. proposed changes, we stated that we budget neutral. With the finalization of the State’s new were not proposing any changes to the In this final rule, we are finalizing the EHB-benchmark plan options at policies governing State-required approach described above of not making § 156.111, States will continue to have benefits at § 155.170. That is, whether a changes to the policy under § 155.170. the authority to implement benefit benefit mandated by State action could Comment: Many commenters mandates as part of EHB, in accordance be considered EHB would continue to requested changes to the policies with § 155.170. depend on when the State enacted the governing State-required benefits at Specifically, if a State selects a new mandate (unless the benefit mandated § 155.170 in light of new EHB- EHB-benchmark plan under any of the was for the purposes of compliance with benchmark plan selection options options finalized in this rule at Federal requirements). Under any of the established at § 156.111. Some of these § 156.111, the benefits mandated by the proposed methods for a State to select commenters were concerned about selecting State’s action prior to or on a new EHB-benchmark plan, benefits States selecting a more generous December 31, 2011 will continue to be mandated by a State action prior to or benchmark plan under the proposed considered EHB and will not be subject on December 31, 2011 would be options at § 156.111(a) that could reduce to defrayal, in accordance with considered EHB in that State according affordability by allowing the selecting § 155.170. If the State is selecting from to the continuing policy described State to include another State’s another State’s EHB-benchmark plan above and would not require State mandates in its benchmark plan and under the first or second option, as defrayal. However, State-required thereby allow the selecting State to discussed in preamble to § 156.111, and benefits mandated by State action taking indirectly adopt another State’s the selected EHB-benchmark plan (or place after December 31, 2011, other mandates without defrayal. These category of services) includes benefits than for purposes of compliance with commenters recommended that States mandated by the State from which the Federal requirements, would continue be required to defray the costs of any plan originated that are EHB, those additional required benefits that result to be considered in addition to EHB benefits will also be incorporated into from the selection of a new EHB- even if embedded in the State’s newly the selecting State’s EHB-benchmark benchmark plan if those benefits are selected EHB-benchmark plan under the plan without a requirement that the more generous than the State’s previous proposals at § 156.111. Therefore, their selecting State defray their related costs, EHB-benchmark plan, regardless of costs would be required to be defrayed unless the selecting State has its own whether the additional benefits were by the State. mandates regarding these same benefits As discussed more fully in the put in place by the newly-selected EHB- and those mandates meet the preamble for § 156.111, we proposed benchmark plan or were the result of requirements for defrayal in § 155.170. benefits mandated by State action in the Relatedly, our decision to maintain that § 155.170 would continue to apply selecting State. Other commenters were the policies governing State-required in the same manner as it currently concerned that the current policy of benefits at § 155.170 is motivated by our 42 See 155.170(b) and (c). Also see the EHB Rule, requiring States to defray the costs of goal to provide States with more available at https://www.gpo.gov/fdsys/pkg/FR- State-required benefits mandated after flexibility and reduce administrative 2013-02-25/pdf/2013-04084.pdf, the 2016 Payment December 31, 2011, other than for burden for selecting a new EHB- Notice Final Rule, available at https://www.gpo.gov/ purposes of compliance with Federal benchmark plan under Option 1 or 2 fdsys/pkg/FR-2015-02-27/pdf/2015-03751.pdf, and the 2017 Payment Notice Final Rule, available at requirements, would prevent States described in § 156.111. Specifically, we https://www.gpo.gov/fdsys/pkg/FR-2016-03-08/pdf/ from updating benefits in response to believe that many benefits that are State 2016-04439.pdf. medical advances and their population’s mandates are likely already embedded

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in States’ existing 2017 EHB-benchmark both the State and Federal perspective, oversight of networks to ensure that the plans, and removing them would be and to promote the goal of returning States in fact have the capacity to ensure complicated for a selecting State. In regulatory authority over the insurance health plan compliance. Other particular, we are concerned that this markets to States, we proposed to commenters supported this proposal, additional level of effort would create a eliminate requirements for SBE–FPs to stating that they believe networks are barrier to States trying to select another enforce FFE standards for network best developed and regulated at the State’s 2017 EHB-benchmark plan under adequacy at § 155.200(f)(2)(ii) and State level to allow for variations in Options 1 or 2 being finalized at essential community providers at State geography, demographics, and § 156.111(a)(1) and (2), particularly § 155.200(f)(2)(iii). Instead, we proposed market conditions. when several types of benefits mandated that the SBE–FPs, like other State Response: We are finalizing the by State action overlap with one of the Exchanges, would have the flexibility to proposal to remove the requirement that ten EHB categories. More specifically, determine how to implement the SBE–FPs establish and oversee because benefits mandated by State network adequacy and essential requirements for their issuers that are no action are generally EHB if the mandates community provider (ECP) standards less strict than the manner in which were enacted on or before December 31, with which issuers offering QHPs these regulatory requirements are 2011, and the 2017 EHB-benchmark through the SBE–FP must comply. We applied to FFE issuers. We believe SBE– plans that are used for the options under believe SBE–FPs are best positioned to FPs are best positioned to determine § 156.111 are based on base-benchmark determine these standards for the QHP these standards for the QHP certification plans that were available in 2014, we certification process in their States, and process in their States, and elimination believe that the majority of benefits that the removal of the requirement that of this requirement would streamline mandated by State action that are EHB SBE–FPs establish and oversee certain aspects of the QHP certification in accordance with § 155.170 are requirements for their issuers that are no process by reducing oversight burden on already embedded in the originating less strict than the manner in which SBE–FPs. State’s EHB-benchmark plan these regulatory requirements are Section 155.200(f)(4) describes documents. applied to FFE issuers would streamline requirements for States that operate an We also note that we are finalizing certain aspects of the QHP certification SBE–FP for SHOP. As discussed earlier that all options for a State to select a process, and return traditional in this preamble, although we proposed new EHB-benchmark plan described in insurance market regulatory authority to that States can no longer elect to operate § 156.111 are limited by a generosity the States. Additionally, HHS proposed SBE–FPs for SHOP after the effective standard. This generosity standard will that, for 2019 plan years and later, the date of this rule, which we are finalizing limit the State’s ability to increase the FFEs would rely on State reviews of as proposed, Kentucky and Nevada are overall scope of benefits in its EHB- network adequacy standards where the already approved to operate SBE–FPs benchmark plan beyond the generosity States have been determined to have an for SHOP, and thus the requirements in of a set of comparison plans that adequate review process. Accordingly, § 155.200(f)(4) remain relevant for those includes a State’s 2017 EHB-benchmark we believe similar deference should be SBE–FPs for SHOP. Therefore, we plan and any of the State’s base- granted to States with SBE–FPs. We proposed to amend § 155.200(f)(4) to reflect the proposed amendments benchmark plan options for the 2017 believe these changes will further (described in section III.D.9 of this final plan year described in § 156.100(a)(1), empower SBE–FPs to use their QHP rule) under which the functionality of supplemented as necessary under certification authority to encourage the FF–SHOPs’ platform would be § 156.110. In practice, this requirement issuers to stay in the Exchange, enter the reduced for plan years beginning on or limits States’ overall ability to select a Exchange for the first time, or expand after January 1, 2018. Specifically, we new EHB-benchmark plan that transfers into additional service areas. We are proposed to amend the introductory text benefits that were previously only finalizing these changes as proposed. We also proposed to remove the to § 155.200(f)(4) to describe the applied to the State’s large group requirement at § 155.200(f)(2)(iv) that requirement applicable, effective on the market, or that were mandated by other QHP issuers in SBE–FPs comply with effective date of this rule for plan years States’ actions prior to 2012, into its the Federal meaningful difference beginning on January 1, 2018 and new EHB-benchmark plan. As a result, standard to reflect the removal of beyond, and to make the requirements we believe that this approach balances § 156.298 described elsewhere in this in paragraphs (f)(4)(i) through (vii), our goal to promote State flexibility rule. We are finalizing this change as effective on the effective date of this with the need to preserve coverage proposed. rule applicable for only plan years affordability. For additional discussion Comment: Several commenters beginning prior to January 1, 2018. on considerations related to § 155.170 opposed eliminating requirements for Specifically the requirements in for States that select a new EHB- SBE–FPs to enforce FFE standards for (f)(4)(i) and (iv), which require SBE–FPs benchmark plan using an option network adequacy at § 155.200(f)(2)(ii) for SHOP to align their premium described at § 156.111, see the preamble and ECPs at § 155.200(f)(2)(iii) for the payment and employer contribution to section § 156.111. 2019 benefit year and beyond. They calculation methodologies with those 3. General Functions of an Exchange urged HHS to continue requiring SBE– used by the Federal platform, would not FPs to enforce these FFE standards, apply for plan years beginning on or a. Functions of an Exchange (§ 155.200) stating that some State Exchanges that after January 1, 2018, effective on the The 2017 Payment Notice finalized do not currently use the Federal effective date of this rule. Because under requirements at § 155.200(f)(2) for SBE– platform have adopted less robust our amendments to § 155.705 and newly FPs to establish and oversee certain network adequacy and ECP standards, finalized § 155.706, for plan years requirements for their QHPs and QHP which are critical to providing access to beginning on or after January 1, 2018, issuers that are no less strict than the providers that serve vulnerable the Federal platform for SHOP will no requirements that apply to QHPs and populations. Other commenters longer calculate premium rates or QHP issuers on an FFE. Due to the supported this proposal if the States employer contributions, and will no operational complexities in have an adequate review process, and longer aggregate premium payments (as implementing these requirements from encouraged HHS to monitor State of the effective date of the final rule),

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there will be no further need for such beginning prior to January 1, 2018, amounts available to direct investments alignment for plan years beginning on or effective on the effective date of this to effective and efficient Navigators, after January 1, 2018. rule. which may include selecting a single, Because under the approach we are We are finalizing as proposed the high performing grantee in an Exchange. finalizing, the Federal platform will changes to § 155.200. Substantive The requirement that one Navigator continue to include plan display with comments related to SHOP proposals grantee in each Exchange must be a premium amounts, we did not propose are summarized in section III.D.9 of this community and consumer-focused changes to the requirement that States final rule. nonprofit group may unnecessarily limit operating an SBE–FP must require its an Exchange’s ability to award grants to b. Navigator Program Standards QHP issuers to make any changes to the strongest applicants, particularly in (§ 155.210) rates in accordance with the timeline an Exchange that opts under this final applicable in a Federally-facilitated Each Exchange is required under rule to have only one Navigator grantee SHOP under current section 1311(d)(4)(K) and 1311(i) of the and where the strongest applicant is not § 155.705(b)(6)(i)(A), which regulation is PPACA to establish a Navigator program a community and consumer-focused mirrored in our proposed introduction under which it awards grants to entities nonprofit group. Keeping this of § 155.706(b)(6)(i)(A). However, we that, among other things: Conduct requirement would effectively exclude proposed to specify that this public education activities to raise any other type of statutorily eligible requirement applies in the introductory awareness of the availability of QHPs, entities from becoming Navigators in an text to (f)(4), to reflect the proposed distribute fair and impartial information Exchange that opts to have only one change to make the requirements in concerning enrollment in QHPs and the Navigator grantee. Eliminating this (f)(4)(i) through (vii) applicable for only availability of PTCs and CSRs, and requirement will provide Exchanges plan years beginning prior to January 1, facilitate enrollment in QHPs. Under with the flexibility to target grants to the 2018, effective on the effective date of section 1311(i)(2)(B) of the PPACA, highest scoring and performing entities, this rule. these entities may include trade, regardless of organization type. Additionally, because under the industry, and professional associations; Removing these requirements at approach we are finalizing, for plan commercial fishing industry § 155.210(c)(2) will also promote years beginning on or after January 1, organizations; ranching and farming Exchange flexibility and autonomy to 2018, the Federal platform will, organizations; community and structure Navigator programs tailored to effective on the effective date of this consumer-focused nonprofit groups; each Exchange. An Exchange could rule no longer calculate whether a chambers of commerce; unions; award a grant to a single Navigator qualified employer has met the resource partners of the Small Business entity from any of the permitted types. applicable minimum participation rate, Administration; other licensed Alternatively, Exchanges could elect to there will no longer be any need for insurance agents and brokers; and other continue awarding two or more grants, States operating an SBE–FP for SHOP to entities that meet the statutory as they have been doing thus far, and align their minimum participation rate requirements at section 1311(i)(3), (4), include a community and consumer- requirements and calculation and (5) of the PPACA. focused nonprofit group among those methodologies with those applicable in Currently, § 155.210(c)(2) specifies grantees. the FF–SHOPs for plan years beginning that each Exchange must include among Section 155.210(e)(7) requires each on or after January 1, 2018. Therefore, its Navigator grantees both a community Navigator entity to maintain a physical we proposed that this requirement and consumer-focused nonprofit group presence in the Exchange service area, would only apply for plan years and at least one other entity that is from so that face-to-face assistance can be beginning prior to January 1, 2018, one of the other categories listed at provided to applicants and enrollees. effective on the effective date of this § 155.210(c)(2), including other public We proposed to remove this rule. or private entities or individuals that requirement to provide more flexibility To align with our amendments at meet the requirements of § 155.210. to each Exchange to structure its § 155.725 and newly finalized § 155.726, Section 155.210(c)(2)(viii) specifies that Navigator program to best serve the under which the FF–SHOPs, effective these other entities may include Indian Exchange service area, and as discussed on the effective date of this rule, for tribes, tribal organizations, urban Indian further below, are finalizing this plan years beginning on or after January organizations, and State or local human amendment as proposed. Under section 1, 2018, will no longer establish annual service agencies. 1311(i)(2)(A) of the PPACA and employee open enrollment periods, or To maximize the flexibility and § 155.210(c)(1)(ii), entities seeking to establish effective dates of coverage for efficiency of the Navigator program, we become Navigator grantees must an initial group enrollment or group proposed to amend § 155.210(c)(2) to demonstrate to the Exchange that they renewal, we also proposed that the remove the requirements that each have existing relationships, or could requirements in § 155.200(f)(4)(v) and Exchange must have at least two readily establish relationships, with (vi) would only apply for plan years Navigator entities and that one of these employers and employees, consumers beginning prior to January 1, 2018, entities must be a community and (including uninsured and underinsured effective on the effective date of this consumer-focused nonprofit group. As consumers), or self-employed rule. Finally, to align with our discussed further below, we are individuals likely to be eligible for amendments at § 155.735, under which finalizing this amendment as proposed. enrollment in a QHP. Consistent with the FF–SHOP, effective on the effective We believe removing these requirements those provisions, Navigator grant date of this rule for plan years beginning will provide Exchanges with improved applicants in the FFEs are scored on on or after January 1, 2018, will no flexibility to award funding to the their ability to make this demonstration. longer determine the timing, form, and number and type of entities that will be Based on HHS’s experience with manner in which coverage or most effective for the specific Exchange. Navigator programs in FFEs and other enrollment in a SHOP QHP may be We believe that eliminating the public programs, we believe entities terminated, we proposed that the requirement to have at least two with strong relationships in their FFE requirement in § 155.200(f)(4)(vii) Navigator entities will allow each service areas tend to deliver the most would only apply for plan years Exchange to optimally use the funding effective outreach and enrollment

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results. However, we believe that each funding to the number and type of rule), would be unable to select its Exchange is best suited to determine the entities that would be most effective for strongest applicant absent a change to weight to give a physical presence in the each specific Exchange. We appreciate the requirement that one Navigator Exchange service area when selecting the importance of consumer access to grantee in each Exchange must be a Navigator entities, as long as the experienced, in-person assistance, and community and consumer-focused Exchange’s Navigator grantee selection believe this change will allow each nonprofit group. We also agree with process is consistent with section Exchange to optimally use available commenters that removing this 1311(i)(2)(A) of the PPACA and funding amounts, such as by selecting a requirement will support Exchange § 155.210(c)(1)(ii). single, high-performing grantee in an flexibility and autonomy to structure For reasons similar to those Exchange. In this way, we do not Navigator programs tailored to each motivating our proposed changes to believe this change will have a Exchange and target grants to the § 155.210(e)(7), as well as to promote detrimental effect on the availability of highest scoring and performing entities, consistency across programs, we professional, unbiased, in-person regardless of organization type. We proposed to remove the corresponding consumer assistance. Additionally, the believe that Exchanges are well-situated requirement at § 155.215(h) that requires proposal does not require an Exchange to determine the proper use of the maintenance of a physical presence in to have only one Navigator. It simply funding amounts available and are able the Exchange service area by all non- provides Exchanges with that option. to determine the type of entity or Navigator entities subject to § 155.215. We are finalizing this change as entities that will serve their Exchange We are also finalizing this amendment proposed. service areas best. We are finalizing this as proposed. Comment: We received comments in change as proposed. In addition to the requirement to support of removing the requirement Comment: We received comments in maintain a physical presence in the that each Exchange must have one support of removing the standard Exchange service area, §§ 155.210(e)(7) Navigator entity that is a community requiring Navigators to maintain a and 155.215(h) currently provide that, and consumer-focused nonprofit. physical presence in the Exchange in an FFE, no individual or entity is Several of these commenters supported service area. Several commenters ineligible to operate as a Navigator or HHS’s promotion of Exchange flexibility believed that removing this requirement non-Navigator assistance personnel with this change. However, many will provide Exchanges with greater solely because its principal place of commenters expressed concern about flexibility and enable them to expand business is outside of the Exchange removing this requirement, conveying options for consumer support. On the service area. We did not propose to that Navigators, and in particular other hand, many commenters believed amend or remove that language, and it independent, nonprofit Navigators, have that entities not physically present in an will remain in effect. proven to be a critical resource for Exchange service area may not be able In addition to seeking comment on helping consumers enroll in coverage to provide a full spectrum of local the proposed amendments described that is appropriate for their needs in outreach, education, and assistance to above, we also sought comment on previous enrollment periods. Many support enrollment and post-enrollment statutorily acceptable alternative types commenters stated that nonprofit activities. Many commenters suggested of entities that could serve as Navigators Navigator entities are unique among that removing this requirement would and on possible new ways in which other types of Navigator groups because negatively affect hard-to-reach Navigators could carry out their duties. they typically have expertise with one populations, as the in-person assistance Comment: We received comments in or more hard-to-reach populations provided by Navigator entities is often support of removing the requirement within their communities, such as the only known resource and form of that each Exchange must have at least veterans, limited English proficiency support for some low-income and other two Navigator entities. Several individuals, or other targeted at-risk populations. In addition, some commenters believed that adopting this populations, and have the trust of many commenters believe that web or phone- change could assist HHS with ensuring community members. In addition, based assistance is a poor substitute for that Navigator grants are expended commenters suggested that this in-person assistance delivered by a efficiently and effectively. Many requirement was initially added to known and trusted community-based commenters, however, expressed address concerns about fraud, abuse, organization, and that this is concern about reducing the number of and the difficulty that Exchanges faced particularly true for those living with required Navigator entities per overseeing other types of Navigator significant health needs for whom Exchange, conveying that removing this entities. remote assistance may prove inadequate requirement could potentially Response: We agree with commenters and frustrating. negatively affect consumer access to in- who emphasized the importance of Response: We agree with commenters person assistance, and therefore make it funding nonprofit Navigator entities, who emphasized the importance of harder for consumers to understand and also agree that nonprofit Navigator providing more flexibility to each their coverage options and enroll in entities often have expertise with one or Exchange to structure its Navigator health coverage. Several commenters more hard-to-reach populations within program to best serve the Exchange’s suggested that having two Navigator their communities. Nothing in this rule service area. As we stated in the entities per Exchange ensures that an prevents an Exchange from selecting proposed rule, we believe that entities Exchange can have a general entity and and funding a nonprofit Navigator entity with a physical presence and strong one more tailored to specific needs if it determines that such an entity best relationships in their FFE service areas within an Exchange, such as a focus on meets the needs of the community tend to deliver the most effective young adults, limited English proficient served by the Exchange. However, we outreach and enrollment results. individuals, or other targeted also recognize that there are Nothing in this final rule prevents an populations. circumstances in which another type of Exchange from selecting grantees that Response: We agree with commenters entity may be the strongest applicant. In are physically present and available to who stated that removing these these cases, an Exchange that chooses to provide a spectrum of in-person, local requirements will provide Exchanges have only one Navigator grantee (as outreach, education, and assistance, with improved flexibility to award permitted by the change finalized in this including directing these services

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towards vulnerable and hard-to-reach c. Standards Applicable to Navigators applicable requirements in §§ 155.220, populations, if the Exchange elects to and Non-Navigator Assistance 155.260, 156.265, and 156.1230, and weight its selection process in that way Personnel Carrying Out Consumer would need to be completed prior to the and its selection process is consistent Assistance Functions Under use of the agent, broker, or issuer with section 1311(i)(2)(A) of PPACA §§ 155.205(d) and (e) and 155.210 in a internet website for submission of an and § 155.210(c)(1)(ii). Furthermore, we Federally-Facilitated Exchange and to Exchange application or completion of believe that there are various Non-Navigator Assistance Personnel QHP selection. HHS would publish organizations that might prove to be Funded Through an Exchange technical guidance outlining the review promising partners in the delivery of Establishment Grant (§ 155.215) standards and other operational details, both local and remote consumer For a discussion of the provisions of as well as provide other resources to assistance with regard to health this final rule related to standards assist the third-party entities in coverage enrollment and education. applicable to non-Navigator Assistance conducting the reviews at a later date. As outlined in the last sentence of the While in-person assistance may be more Personnel subject to § 155.215, please new § 155.221(a), the third-party entity helpful than remote services in some see the preamble to § 155.210. would be a downstream or delegated situations, we believe that determining d. Standards for Third-Party Entities To entity of the agent, broker, or issuer that which entities are well-situated to serve Perform Audits of Agents, Brokers, and participates or wishes to participate in consumers within a particular Exchange Issuers Participating in Direct direct enrollment. Therefore, these is best left up to each Exchange. By Enrollment (§ 155.221) third-party entities would be subject to allowing Exchanges greater flexibility, HHS proposed new standards in the HHS oversight as delegated or each Exchange will be better able to proposed rule to replace the standards downstream entities of an agent, broker, ensure that its service area can be set forth in the 2018 Payment Notice for or issuer, and the agent, broker, or issuer assisted by the entity or entities that § 155.221 for third-party onboarding will remain responsible for compliance best fits the needs of its population. We operational readiness reviews and with all applicable direct enrollment are finalizing this change as proposed. audits for direct enrollment partners. requirements. Comment: We received comments HHS also proposed to expand the We also proposed revisions to about the potential use of other entities applicability of this section to require § 155.221(b), which establishes to provide enrollment assistance or issuers, in addition to agents and standards that third-party entities must remote services to consumers, beyond brokers, participating in direct satisfy to perform the reviews to Navigator entities. Some commenters enrollment to engage third-party entities demonstrate operational readiness conveyed that other types of to conduct the required operational under § 155.220(c)(3)(i)(K) and organizations are well-situated to readiness reviews. We proposed a § 156.1230(b)(2), beginning with the provide enrollment assistance, such as conforming edit to § 156.1230(b)(2) to open enrollment period for the 2019 local agents and brokers and direct reflect this proposal. benefit year. The proposed new enrollment partners. Some commenters HHS proposed to implement an introductory language at § 155.221(b) believe that an approach to consumer approach wherein agents, brokers, and aligns with the new approach where the issuers that participate in direct agent, broker, or issuer selects the third- assistance that leverages experts from enrollment and use their own internet party entity to perform the audit under different types of organizations that website for QHP selection or to paragraph (a). As proposed, new have strong ties to the community is a complete the Exchange eligibility § 155.221(b)(1) would require the entity comprehensive way to provide application would select their own to have experience conducting audits or consumers with the best available third-party entities for conducting similar services, including specific expertise. audits, rather than requiring HHS to experience with relevant privacy and Response: We agree that local initially review and approve these security standards due to the collaboration and leveraging community entities. As detailed in the proposed operational requirements of the current partnerships can help in reaching rule, HHS anticipates this approach direct enrollment processes and any marginalized communities. For FFEs, would reduce the regulatory burden for potential future enhancements. This we will take these comments into agents, brokers, and issuers, and reduce would include demonstrated experience consideration when drafting Navigator duplicative HHS oversight. This with current National Institute of selection criteria for Navigator funding approach will also reduce the burden on Standards and Technology (NIST) SP opportunity announcements in future third-party entity reviewers. 800–53 or the HIPAA Security Rule years. While agents, brokers, and direct Beginning with the open enrollment standards, and the review of compliance enrollment partners might in many period for the 2019 benefit year, we with those standards. We proposed that cases not be eligible to become proposed that an agent, broker, or issuer auditors must also be capable of Navigators due to statutory limitations must engage a third-party entity that performing penetration testing on all meets the standards outlined in the new interfaces that collect personally on Navigator eligibility at section § 155.221(b) to conduct an annual identifiable information or connect with 1311(i)(4) of PPACA, we also agree that operational readiness review prior to HHS. We proposed to modify agents, brokers, and direct enrollment participating in direct enrollment. § 155.221(b)(2) to include issuers partners can be well situated to provide Consistent with § 155.220(c)(3)(i)(K) and participating in direct enrollment and to enrollment assistance or remote services § 156.1230(b)(2), the operational expand the scope of the audit to also to consumers, and we intend to readiness review would be performed include review of compliance with continue to work with these using the third parties’ own audit other applicable program requirements stakeholders to ensure consumers in processes and methods subject to HHS- (for example, website design, or FFEs have access to a range of defined specifications and consumer disclosures). Under proposed enrollment assistance, including requirements. The third-party entity’s § 155.221(b)(3), auditors would be Navigators. review would verify compliance by the required to collect, store, and share with agent, broker, or issuer with the HHS all data related to its audits of

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agents, brokers, and issuers under ‘‘OIG’’. We have put in place guidelines We are finalizing this policy as paragraph (a) in a manner, format, and and processes to oversee the activities of proposed. frequency specified by HHS until 10 agents, brokers, and issuers Comment: Nearly all commenters on years from the date of creation, and participating in direct enrollment, and this issue expressed concern that relying would be required to comply with the anticipate continuing to monitor on a notice that is not explicit to inform privacy and security standards HHS enrollments through the direct consumers that APTC eligibility may be adopts for agents, brokers, and issuers as enrollment pathway for evidence of discontinued—without giving required in accordance with § 155.260. fraud or abuse. While we acknowledge consumers the specific reason and The proposed revisions to paragraph the potential for conflicts of interest, we clearly instructing them how to correct (b)(4) would implement a conflict of believe the required disclosures, the issue—is insufficient to ensure those interest standard that requires continuous monitoring and oversight, wishing to continue their eligibility disclosure of financial relationships and standards established for third- have the necessary information to do so. between a third-party entity conducting party auditors will sufficiently mitigate A few commenters stated that FFE 43 a direct enrollment operational these concerns. Furthermore, we believe notices are often difficult for consumers readiness review and the agent, broker, the requirements being finalized in this to understand, and consumers often or issuer. In addition, the third-party rule will ensure that quality operational bring their notices to assisters for help entity would be required, under readiness reviews are conducted. Lastly, understanding them. One commenter § 155.221(b)(5), to comply with all we agree that it is important that stated that this confusion can be applicable Federal and State consumers enrolling using direct compounded for non-English or non- requirements; under § 155.221(b)(6), to enrollment be able to make informed Spanish speakers, who often are unable ensure, on an annual basis, that decisions about coverage. We believe to understand notices because they are appropriate staff successfully complete § 155.220, which establishes standards unable to read them and may not take operational readiness review training as that apply when Exchange consumers the notices to an enrollment assister or established by HHS prior to conducting select an individual market QHP otherwise have the notice translated in audits under paragraph (a) of this through an agent’s or broker’s website, time to take the appropriate action. One section; and, under § 155.221(b)(7), to including a requirement that agents and commenter recommended Exchanges permit access by the Secretary and the brokers engaged in direct enrollment send multiple notices regarding failure Office of the Inspector General (OIG), or display all QHP data provided by the to file and reconcile to affected their designees, in connection with their Exchange, will help promote informed consumers and tax filers. right to evaluate through audit, consumer choice about all available Response: We recognize that inspection, or other means, to the third- QHPs, not just those with which the describing complex information about party entity’s books, contracts, agent or broker has an existing eligibility for APTC to consumers involves a complicated balance between computers, or other electronic systems, relationship. relating to the third-party entity’s audits providing complete and accurate of agents, broker’s, or issuer’s 4. Exchange Functions in the Individual information, and being clear and obligations in accordance with Federal Market: Eligibility Determinations for concise enough that the consumer is standards under paragraph (a) of this Exchange Participation and Insurance likely to read and understand the section until 10 years from the date of Affordability Programs information. Understanding this creation. Finally, to provide flexibility, a. Eligibility Standards (§ 155.305) information can be especially under § 155.221(c) an agent, broker, or challenging for non-English speakers. issuer would be permitted to engage Section 155.305(f)(4)(i) prohibits an Exchanges must notify consumers when multiple third-party entities to perform Exchange from determining a consumer they make eligibility determinations the audits under paragraph (a) and each eligible for APTC if APTC payments based on FTR, but rules on the such third-party entity would need to were made on behalf of the tax filer for disclosure of Federal tax information separately comply with the standards the consumer’s household (or either (FTI) present significant challenges in under paragraph (b). We are finalizing spouse, if the tax filer is married) for a communicating with this population. these amendments as proposed, with a previous year for which tax data would Historically, all communications minor, non-substantive change be used for verification of household regarding FFE applicants and enrollees described below. income and family size, and the tax filer are addressed to the household contact, Comment: Most commenters were or his or her spouse did not comply who in most cases is the tax filer for the concerned that enrollment through a with the requirement to file an income applicants on the relevant application. non-governmental site would occur tax return and reconcile APTC paid on Internal Revenue Service (IRS) rules without proper oversight and controls. their behalf that year. Under the current generally prohibit the disclosure of FTI They expressed concern about the regulation at paragraph (f)(4)(ii), to anyone other than the tax filer, and potential for fraud, or the possibility Exchanges cannot discontinue APTC FTI includes all information from a tax that agents, brokers, and issuers would due to a failure to file and reconcile return, including information as to unfairly direct consumers to QHPs with (FTR) associated APTC unless direct whether a tax return has been filed with which the agent, broker, or issuer, had notification is first sent to the tax filer IRS. Also considered FTI is any list that an existing relationship. Additionally, a that his or her eligibility will be is generated based only on information number of commenters were concerned discontinued as a result of the tax filer’s that is FTI itself. For example, a list of about the potential for conflicts of failure to comply with the requirement consumers who have not filed a tax interest arising from relationships specified under paragraph (f)(4)(i) of return is considered FTI. The FFE’s between the agents, brokers, and issuers § 155.305. current noticing infrastructure does not and the third-party auditors they select We proposed to amend § 155.305(f)(4) to conduct their audits. by removing the direct notification 43 All Exchanges using the Federal eligibility and Response: We are finalizing the requirement in paragraph (f)(4)(ii) and enrollment platform, including SBE–FPs, take the same approach to handling FTR associated APTC. modifications to § 155.221 as proposed, revising the remaining paragraph (f)(4) Therefore, in this section, the term ‘‘FFE’’ describes with a minor non-substantive edit to to move the content in paragraph all Exchanges using the Federal eligibility and paragraph (b)(7) to remove the acronym (f)(4)(i) into paragraph (f)(4). enrollment platform.

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have FTI privacy safeguards built into U.S. mail) that will be available in Response: We recognize there are its system to send notices to tax filers consumers’ online accounts and to the limitations with the combined notices, (as distinct from the household contact), Exchange call center; and (2) a direct which are unable to be explicit; to store notices in a manner compliant notice sent via U.S. mail to the tax filer however, this approach may be the only with required protections for FTI, or to that is not available electronically in the option available to many State establish user permissions for approved household’s online account or to the Exchanges whose systems (including Exchange and Exchange contractor Exchange call center, in order to protect notice functionality) were not built for personnel only to access these notices FTI. The direct notice serves to FTI compliance, and for which costly for operationally necessary purposes, unambiguously explain that the tax filer and time-consuming infrastructure such as Call Center support, casework, has been identified as having failed to upgrades are infeasible in the short or appeals. meet the requirement to file and term. As described previously, the FFE To avoid unauthorized disclosure of reconcile and must come into has begun mailing FTI-compliant direct FTI to individuals who are not the compliance to avoid termination of notices to tax filers that contain a relevant tax filer, the FFE sends notices APTC. In 2018, the FFE will also send statement of the intended action, to FTR and non-FTR consumers that a combined notice and a direct notice in reasons for the action including contain language regarding FTR, but connection with its periodic check of regulatory support for the action, and an also language that is broad enough to tax data described in explanation of the individual’s appeal apply to all consumers who receive § 155.330(e)(2)(iii)(B). As commenters rights if APTC is discontinued. While them; these notices are referred to as noted, we believe sending more than the FFE has been able to develop this ‘‘combined notices.’’ For example, the one notice may increase the likelihood workaround to provide FTI-compliant FFE sends the same Marketplace Open that consumers identify and read the notices directly to tax filers, SBEs may Enrollment Notice to three groups of notices and ultimately take action. have fewer options available to them. consumers at risk for APTC Comment: Many commenters While some SBEs may be able to discontinuation in the upcoming disagreed with our suggestion that a contract with the FFE’s print contractor coverage year: Those flagged as FTR, success rate of 60 percent of FFE or another FTI-compliant contractor, we those for whom the FFE has received household tax filers taking appropriate have heard that some are required to use updated income information that action to file and reconcile in response only in-State contractors, which can suggests the consumers may have to the combined notices was sufficient create a significant barrier if there are no income too high to qualify for APTC, and stated that 40 percent of households FTI-compliant contractors in the State. and those who did not permit the failing to take appropriate action We agree with commenters that it is Exchange to check IRS data. Because the demonstrates the lack of clarity the important for all Exchanges to protect consumers’ due process rights. Even in combined notices apply and are sent to combined noticing approach creates some consumers who are currently the case of an Exchange that cannot among consumers. unaffected by FTR, and not exclusively arrange to send direct notices that Response: We agree that there is room to individuals who are affected by FTR, explicitly address FTR to the tax filer these notices are not considered FTI for improvement on a success rate of 60 and that is limited to the combined under IRS rules and are able to be sent percent. We foresee this success rate notice approach, we believe there are using the standard FFE notice rising as the Exchanges mature and adequate protections for due process. functionality. consumers become more familiar with First, the tax filer still has an To supplement the combined notice, the requirement to file and reconcile, opportunity before the Exchange in November 2017, the FFE also mailed and as the FFE continues pairing the redetermines eligibility to file a tax warning notices that complied with FTI combined notices with direct notices to return (or an amended tax return, as rules to tax filers on whose behalf APTC tax filers that more explicitly address applicable) and reconcile APTC paid for was being paid but for whom the FFE the requirement to file and reconcile. the relevant benefit and tax year. We had information the tax filer had not Comment: Many commenters were expect Exchanges to send appropriate met the requirement to file and concerned that our proposal to remove notices to households affected by FTR reconcile. These notices, which we refer § 155.305(f)(4)(ii) does not comply with that alert the tax filer that FTR may be to as ‘‘direct notices,’’ urged the tax constitutional due process rights— the reason enrollees’ eligibility for filers to file and reconcile to avoid stating that when determining a tax filer APTC is at risk. Second, for enrollees losing APTC starting in January 2018. ineligible to continue receiving APTC, whose eligibility for APTC is terminated To comply with FTI requirements, the Exchanges must issue a direct as a result of FTR, the enrollee will direct notices were not generated by the individual notice that contains a receive an updated eligibility FFE itself; rather, data was securely sent statement of the intended action, determination notice that contains a full to an FTI-compliant print contractor for reasons for the action, specific legal explanation of appeal rights. Enrollees printing and mailing. In order to be FTI- support for the action, an explanation of who appeal may request to continue compliant—including being accessible the individual’s hearing rights, and receiving financial assistance during the only to the tax filer—direct notices are rights to representation and to appeal, consistent with § 155.525. We not available through the online continued benefits. They expressed believe these measures, including the Exchange account for the application. concerns about consumer confusion option to maintain eligibility during an We intend for the FFE to continue given that neither the FFE’s combined appeal, are consistent with due process. sending two notices in advance of open (non-FTI) notices nor follow-up through Comment: Some commenters stated enrollment where the Exchange has the call center can give consumers that tax filers have a property interest in information that the tax filer on whose definitive guidance on their household the continued receipt of APTC for behalf APTC is being paid has failed to tax filer’s current tax filing status, which they are eligible, and challenged meet the requirement to file and whether they will be redetermined our belief that the financial and reconcile: (1) A combined notice ineligible for APTC for the upcoming operational burden for the Exchange of provided according to the benefit year (and why), how to correct establishing a mechanism to notify tax communication preference set for the the problem, or how to challenge a filers without making an unauthorized household contact (electronic or via redetermination of eligibility for APTC. disclosure of protected FTI would be

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out of proportion with the limited need options, as discussed above. The FFE abandonment. One commenter for FTI handling in Exchange plans to continue sending direct notices suggested that the combined notice sent operations, including generating to tax filers to supplement the combined to the household contact explain that notices. Some referenced a Federal notices; we encourage SBEs to take a the specific reason for the potential judicial decision 44 stating that the similar noticing approach, where discontinuation of APTC will be ‘‘public interest in assuring that health feasible. We are available to provide contained in the direct notice to the tax benefits will not be erroneously technical assistance, as needed. filer. This commenter further suggested terminated or denied outweighs the Comment: A few commenters that the mailing addresses be verified State’s competing fiscal and recommended more research be done against the United States Postal Service administrative concerns. Any prior to the rule change. One commenter National Change of Address Database to inconvenience the State might suffer is suggested we learn more about why help ensure deliverability, and that the out-balanced by the State’s and the taxes are not being filed in a timely way, envelopes be conspicuous to signify recipient’s interest in providing health suggesting there may be many reasons their importance (for example, red in benefits to those who cannot otherwise for non-compliance, and that this color). afford them.’’ additional understanding could inform Response: We recognize there are One SBE supported the proposal to appropriate Exchange and IRS policies. household circumstances in which the remove the direct notification provision Other commenters recommended we tax filer and the household contact on in § 155.305(f)(4)(ii), citing significant retain the current rule until we the application do not live together. implementation challenges to understand the impact of the new direct However, our data show that for 2017 communicate with consumers without notice mailed in November 2017 to FFE and 2018 applications for which any violating IRS’s FTI security protections. enrollee tax filers affected by FTR. They amount of APTC was paid, 99.8 percent It stated that current FTR processes and suggested that, following the open of household contacts listed on the notifications being implemented by enrollment period for 2018, we should application were also the tax filer. We most Exchanges provide adequate notice assess whether there was an increase in agree that adding language to the to consumers. the proportion of tax filers who took the combined notice pointing to the direct Response: HHS is committed to necessary action to file their tax return notice for additional specifics may help ensuring consumers eligible for APTC and reconcile APTC, and a decrease in increase the likelihood that the tax filer maintain that important benefit; consumer confusion (for example, fully understands the risk to continued however, we also believe that ensuring evidenced by the number of FTR-related APTC eligibility for enrollees in the consumers are not receiving APTC call center questions), and consider household, and we may explore this improperly is necessary for program whether any change is due to the approach through discussions with IRS integrity. Additionally, it is important to cumulative impact of the two notices regarding any potential FTI concerns. reduce burden on Exchanges, which before finalizing any regulatory changes The FTI-compliant print contractor used have varying capacities. Establishing a related to FTR procedures. by the FFE in November 2017 does mechanism through which to notify tax Response: We agree that gathering verify addresses against the USPS filers without making an unauthorized data on the effectiveness of FTR notices National Change of Address Database, disclosure of protected FTI is a heavy is a worthwhile endeavor, and we look and we acknowledge that making undertaking for an Exchange if its forward to analyzing the numbers as envelopes more conspicuous could help notification system was not originally suggested by the commenter, now that ensure FTR notices are opened and read designed with that capability in mind. the open enrollment period for 2018 by consumers. For the FFE, it would involve not only coverage is closed, to determine if When consumers submit an FFE changes to its notice generation and recent messaging increased compliance application, the filer of the application storage infrastructure, including and reduced the discontinuation of must agree to a statement that he or she enhancements to segregate and secure APTC as a result of FTR. However, we has obtained consent for all people FTI data, but also substantial believe this regulatory change must be listed on the application for their modification to its entire account implemented in the short term in the information to be used for eligibility creation framework.45 For a number of interest of program integrity and to determination purposes, including SBEs, upgrading their systems to be FTI reduce burden on Exchanges. verifying this information using the compliant represents an undertaking Comment: A few commenters Exchange’s trusted electronic data that may be infeasible to implement in discussed the limitations when the sources. In addition, following the short term. SBEs may also be unable household tax filer (to whom the FFE application submission and when to take the FFE’s dual noticing approach sent the direct notice in November selecting a plan and choosing the because of limited print contracting 2017) does not reside with the amount of APTC to apply to the household contact on the application (to monthly premium, the tax filer is 44 Rodriguez by and through Corella v. Chen, 985 whom the FFE sent the combined required to agree to a statement that he F.Supp. 1189 (D. Ariz. 1996). Marketplace Open Enrollment Notice in or she must file a tax return for the year 45 The FFE’s current workaround of sending October 2017), which could hinder the during which APTC is paid on his or print-only FTI notices directly to tax filers is being affected individual’s ability to her behalf (or on behalf of his or her performed outside of the FFE’s standard notice processes, which allow household contacts to be understand the totality of the spouse) and to reconcile those payments notified according to their communication circumstances, and disagreed with our with IRS. The filer of the application preferences (U.S. mail or electronic) and provides assumption that the household contact specifies the contact person for availability of all notices in consumers’ online is likely to share the combined notice Exchange communications (the accounts. At a minimum, enhancements to the FFE’s identity proofing requirements for all FFE with the tax filer, since not all household contact), as well as the accounts would be required in order to prevent household contacts and tax filers on an method of communication they prefer— disclosure of FTI information to anyone except the application can readily and easily either electronic or via U.S. mail to the tax filer. Further, the call center’s identity proofing communicate with one another, address they enter on the application. practices and data systems would need to be enhanced to safeguard the information to an FTI including during medical or other Because this household contact is standard, in order to continue assisting consumers emergency situations, death, separation designated as the point of contact for the with the application and enrollment process. or divorce, domestic abuse, or spousal enrollee(s) on the application, we

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believe it is reasonable to assume he or integrity perspective when both the account that consumers with incomes she intends to receive communications attestation and data from trusted data near 100 percent FPL have a smaller about enrollees’ eligibility for and sources are over 100 percent Federal margin for error in dollar terms. enrollment in health coverage through poverty level (FPL), since an attestation Therefore, a reasonable threshold might the Exchange. Further, as this that is higher than data from trusted also include a fixed dollar amount in designated point of contact for Exchange data sources in that situation would addition to a percentage threshold. enrollees, we believe this household reflect a lower APTC than would be We are finalizing this policy as contact would likely read these provided if the information from trusted proposed, with two changes. First, after communications, and if their content data were used instead. considering the intended purpose of this discussed risk for financial assistance However, where electronic data new program integrity measure, we have loss, share with the tax filer in the rare sources reflect income under 100 decided to add additional regulatory case that he or she is not the tax filer. percent FPL and a consumer attests to language to § 155.320(c)(3)(iii)(D) that We further believe it is reasonable to income between 100 percent FPL and exempts from this additional assume that the tax filer—if not the 400 percent FPL, where the attested verification check non-citizen household contact—would be in contact income exceeds the income reflected in applicants who are lawfully present and with the Exchange enrollees for whom trusted data sources by more than some ineligible for Medicaid by reason of he or she is responsible with respect to reasonable threshold, we believe it immigration status.46 These applicants tax filing, managing communications would be reasonable to request do not have the same incentive to inflate related to health coverage through the additional documentation to protect their reported household income to Exchange, or both. against overpayment of APTC, since the qualify for APTC, since they are also We are finalizing these provisions as consumer’s attested income could make able to qualify for APTC with a proposed, but remain committed to him or her eligible for APTC that would household income under 100 percent improving the clarity and effectiveness not be available using income data from FPL. Additionally, if these applicants of the FTR notification process in electronic data sources. Accordingly, we inflate their income, they will receive circumstances where the Exchange has proposed to add new paragraphs less APTC than they are eligible for, information that the tax filer has failed (c)(3)(iii)(D) and (E), and to modify and, therefore, performing the to file and reconcile. paragraphs (c)(3)(vi)(C), (D), (F), and (G), additional verification check is not to specify that the Exchange will follow necessary to prevent overpayment of b. Verification Process Related to the procedures in § 155.315(f)(1) APTC. Second, we also removed the Eligibility for Insurance Affordability through (4) to create an annual income proposed regulatory language that Programs (§ 155.320) data matching issue for consumers if: (1) clarified that non-citizens who attested i. Income Inconsistencies (§ 155.320(c)) The consumer attested to projected to projected income under 100 percent annual income between 100 percent and FPL are not subject to this verification, Section § 155.320(c)(3)(iii) sets forth 400 percent of the FPL; (2) the Exchange because the policy only applies to the verification process for increases in has data from IRS and SSA that consumers who attested to projected household income. Generally, if income indicates income is below 100 percent annual income between 100 percent and data from our electronic data sources FPL; (3) the Exchange has not assessed 400 percent of the FPL, and therefore indicate a tax filer’s attested projected or determined the consumer to have would not apply to any applicant (either annual income is more than the income income within the Medicaid or CHIP citizen or lawfully present non-citizen), amount represented by income data eligibility standard; and (4) the making this clarifying language returned by the IRS and the SSA and consumer’s attested projected annual unnecessary. current income data sources, income exceeds the income reflected in At § 155.320(c)(3)(vi)(D), we proposed § 155.320(c)(3)(iii) requires the the data available from electronic data to make changes to provide consistency Exchange to accept the attestation sources by a reasonable threshold with changes finalized in the 2017 without further verification. Currently, established by the Exchange and Payment Notice regarding the threshold Exchanges generally are not permitted approved by HHS. We proposed that a for the generation of annual income data to create inconsistencies (data matching reasonable threshold must not be less matching issues for decreases in annual issues) for consumers when the than 10 percent, and can also include a household income. This proposed consumer’s attested income is greater threshold dollar amount. In accordance change would specify that the 10 than the amount represented by income with the existing process in percent threshold standard no longer data returned by IRS and the SSA and § 155.315(f)(1) through (4), if the applies to cases when a tax filer’s current income data sources. applicant fails to provide attested projected income is less than all We proposed to revise documentation verifying their income data sources, or when no electronic data § 155.320(c)(3)(iii) to specify that the attestation, the Exchange would sources are available. Instead, an Exchange will generate annual income redetermine the applicant’s eligibility Exchange would use the reasonable inconsistencies in certain circumstances for APTC and CSRs based on available threshold established in accordance when a tax filer’s attested projected IRS and SSA data, which under this with § 155.320(c)(3)(vi). We are annual income is greater than the proposal would typically result in finalizing this change as proposed. income amount represented by income discontinuing APTC and CSR as In the proposed rule, we also noted data returned by IRS and the SSA and required in paragraph (c)(3)(vi)(G). The our interest in providing further current income data sources. Current adjustment and notification process guidance on the appropriate thresholds regulations generally require the would work in a manner consistent with for the generation of data matching Exchange to accept a consumer’s other inconsistency adjustments laid out issues generally. We intend to attestation to projected annual in paragraph (c)(3)(vi)(F). reconsider and provide further guidance household income when the attestation We proposed to allow the Exchange to reflects a higher income than what is set the threshold for setting a data 46 FFEs generally verify citizenship/immigration indicated in data from the IRS and matching issue similar to status prior to verifying income. If an applicant’s immigration status has not been verified when the Social Security Administration. This § 155.320(c)(3)(vi). We proposed that a income verification would occur, they would not be approach makes sense from a program reasonable threshold should take into exempted from this additional verification check.

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on these thresholds in the near future, this proposal would exacerbate that practical ability to purchase health and in anticipation of that effort, we problem. Commenters also suggested insurance. sought comment on the appropriate that HHS should more strongly consider Response: HHS understands the thresholds to use at various income providing notice to applicants that they concern regarding these consumers and levels and in various circumstances. In should update their application with believes the alternate verification particular, we welcomed data and any income changes, rather than process will be able to verify income evidence on this issue. creating annual income data matching information for applicants who We intend to address this issue as part issues for this population. accurately reported their income of broader rulemaking and guidance on Response: We recognize that information. Applicants who inflate a number of related program integrity households with lower income might their income to gain access to APTC issues, including further examination of experience higher relative levels of would not be able to produce our processes for denying eligibility for variance in their income from year-to- documentation required to verify their subsidies for individuals who have year. This policy recognizes the need to income attestation, which would failed to reconcile APTC on their have a reasonable threshold for income properly result in the inconsistency Federal income tax return, Exchange discrepancies to allow for normal process under the proposed policy processes for matching enrollment data variations in income, which may determining these applicants ineligible with Medicare and Medicaid in order to include a dollar threshold amount. HHS for APTC. This proposal is designed to address consumers who may be enrolled believes that the alternate verification provide a program integrity check that in duplicative coverage, and our rules process has improved significantly since helps protect taxpayers from the around recalculation of eligibility for the program has launched. The overpayment of APTC. APTC following a mid-year change in calculator used by HHS to calculate Comment: One commenter stated that eligibility. In anticipation of these income submitted by applicants has the proposal would not result in the actions, we sought comment generally been specifically modified to handle Treasury recouping excess APTC paid on these and other program integrity instances where income fluctuates, or is for applicants who inflated their income topics. seasonal in nature. We released a to gain access to APTC because Comment: Several SBEs expressed consumer guide to households to help applicants with household income concerns over the cost and time needed them provide the correct documentation under 100 percent FPL are exempted to implement the change in their IT to verify their income in the event of an from repaying APTC through the systems to accommodate the proposed inconsistency. We also released a reconciliation process at tax time under new verification process. They also worksheet for households to help them current regulations. stated that State Exchanges should have verify their attested income amount. Response: We view this policy as a the flexibility to not conduct this HHS supports encouraging applicants to critical program integrity measure, verification. One commented that there continue to update their income notwithstanding any liability that the is no incentive for applicants to inflate throughout the year, as needed, through tax filer may have when filing income their income in a State that expanded notices and other appropriate consumer taxes and reconciling APTC paid during Medicaid. outreach and educational materials. We the inconsistency period. As observed Response: HHS understands that are also exploring strategies to promote by the U.S. Government Accountability Exchanges may need additional time to more timely and accurate reporting of Office, without proper procedures for implement this proposal in order to changes in circumstances by consumers. verifying incomes and family sizes, the update their information technology Comment: Several commenters risk of providing APTC on behalf of systems to incorporate new logic. expressed concern that HHS did not individuals who do not meet the However, we believe this is a critical provide evidence or data that this issue minimum income eligibility program integrity measure. This process was sufficiently problematic to require a requirements—including those who is primarily intended as a program change in the regulation. may purposefully misstate their integrity safeguard with respect to States Response: HHS acknowledges that it incomes in order to gain access for that did not expand Medicaid. However does not have firm data on the number APTC—is increased.47 Particularly to the verification check could also help of applicants that might be inflating the extent funds paid for APTC cannot identify some applicants who their income to gain APTC, but believes be recouped through the tax inaccurately attested to too high an that it is reasonable to design an reconciliation process, it is important to income amount and were therefore appropriate program integrity check, ensure these funds are not paid out inaccurately determined or assessed not particularly when incentives may exist inappropriately in the first instance. to be eligible for Medicaid. This check for applicants to do so. Comment: One commenter suggested could help applicants identify potential Comment: Commenters also suggested that the proposed policy could result in eligibility through their State Medicaid that instead of generating annual increased churn between Medicaid and program and encourage them to income data matching issues for this coverage through the Exchange for disenroll from their Exchange plan. population, HHS should instead closely Comment: Many commenters were assess the eligibility for loss of MEC 47 U.S. Government Accountability Office, concerned that this new verification special enrollment periods involving the Improper Payments: Improvements Needed in CMS and IRS Controls over Health Insurance Premium process would disadvantage households loss of Medicaid. Tax Credit (July 2017), available at https:// with lower household incomes, since Response: HHS currently monitors www.gao.gov/assets/690/685777.pdf. See, also these households often have income and verifies eligibility for special Office of Inspector General, U.S. Department of amounts that fluctuate more regularly enrollment periods due to loss of MEC, Health and Human Services, Not All of the Federally Facilitated Marketplace’s Internal and by a larger percentage margin than including the loss of eligibility for Controls Were Effective in Ensuring That higher income households. Medicaid/CHIP. Individuals Were Properly Determined Eligible for Additionally, many commenters Comment: Several commenters Qualified Health Plans and Insurance Affordability expressed concern that low-income expressed concern that applicants who Programs (August 2015), available at https:// oig.hhs.gov/oas/reports/region9/91401011.pdf consumers have difficulty in providing could not successfully verify their (concluding that HHS should improve its processes documentation to resolve their annual income in States that have not expanded for verifying income eligibility for insurance income data matching issues and that Medicaid would be left with no affordability programs).

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consumers whose household income requirement to connect to the data complete and accurate to satisfy fluctuates near the 100 percent FPL sources set forth in (d)(2), the Exchange requirements under paragraph (d)(2)(i), level if they are unable to verify their is required to conduct sampling as we stated we anticipate many income for APTC eligibility. The described under paragraph (d)(4)(i), or— Exchanges will fulfill verification commenter was concerned that in States for benefit years 2016 and 2017—it may requirements using an alternate process, that expanded Medicaid, the applicants conduct an HHS-approved alternative as described under paragraph (d)(4). In that lost their APTC would not process instead of sampling, as provided recognition of the challenges that necessarily know that their income may under paragraph (d)(4)(ii). Exchanges may encounter with make them eligible for Medicaid. We proposed to amend conducting sampling, as explained Response: HHS acknowledges this § 155.320(d)(4) to allow an Exchange to below, we proposed to extend the concern and will explore ways to conduct an HHS-approved alternative option for Exchanges to conduct an provide helpful information in any process instead of sampling, as provided alternative process to sampling through notice provided to these applicants that under paragraph (d)(4)(ii), for benefit benefit year 2019. Our hope is that lose APTC because of their inability to years through 2019. When we Exchanges can continue to compile verify their income and may be eligible introduced this option for benefit years databases sufficient to meet verification for Medicaid. 2016 and 2017, we received comments requirements under paragraph (d)(2) We are finalizing the changes as that encouraged us to make this option and to continue to refine their proposed. permanent. However, at the time we approaches to sampling to meet ii. Verification of Eligibility for stated that we believed the alternative verification requirements under Employer Sponsored Coverage process should be used as an interim paragraph (d)(4)(i). (§ 155.320(d)) measure to gather information about the In accordance with the requirement at verification process as Exchanges paragraph (d)(4) to pursue an alternate An employee, or a member of the improve their long-term verification process, the FFE conducted a pilot employee’s family, who is eligible to programs.48 When we first introduced study that incorporated many enroll in qualifying coverage in an this option, we also stated that we components of sampling. The pilot was eligible employer-sponsored plan is not believed the temporary option would intended to assess sampling’s value eligible for the PTC unless the plan’s provide Exchanges with needed protecting the integrity of the attestation coverage for the employee is either flexibility as verification processes are process regarding applicant access to unaffordable, as defined in section refined and employer databases and enrollment in employer-sponsored 36B(c)(2)(C)(i)(II) of the Code, or does compiled, to improve long-term coverage. As part of this sampling pilot, not provide minimum value, as defined verification programs. We noted in the employers for a small sample of in section 36B(c)(2)(C)(ii) of the Code. proposed rule that while Exchanges enrollees receiving APTC through the An employee (or member of the have since gained greater access to data FFEs were contacted by telephone, employee’s family) also is not eligible if and explored approaches to sampling, based on the employer contact he or she actually enrolls in the challenges remain. To reduce regulatory information applicants provided on employer-sponsored plan, even if the burdens on Exchanges while they their Exchange applications, and asked plan is not affordable or fails to provide address remaining hurdles to whether specified employees were also minimum value. developing a long-term approach to enrolled in a qualifying employer- When an individual submits a request verification, we stated we believe the sponsored plan or were offered for an eligibility determination for option to use an alternative process qualifying coverage in an employer- insurance affordability programs, instead of sampling should be extended sponsored plan. Since the FFE does not including as part of the eligibility through plan year 2019. have access to relevant data from verification process for APTC and CSRs, After the option to use an alternate employers across the 38 States for § 155.320(d) requires the Exchange to process for benefit years 2016 or 2017 which the FFE operates Exchanges, this verify whether the applicant reasonably was finalized, HHS investigated the effort provided an attempt to collect expects to be enrolled in an eligible feasibility of connecting to a information on each sampled employee employer-sponsored plan or is eligible comprehensive database of information by contacting employers’ human for qualifying coverage in an eligible on employer-sponsored coverage that resources personnel. The FFE found that employer-sponsored plan for the benefit could be used by all Exchanges to fulfill this approach was not a cost-effective year for which coverage is requested. verification requirements under way for the FFE to fulfill verification Paragraph (d)(2) of § 155.320 describes § 155.320(d)(2)(i). Such a database requirements using an alternate process. the data sources an Exchange must use would be most useful and cost-effective We acknowledged that sampling may to perform verification. Paragraph if it contained information on employer- be a more cost-effective option for SBEs (d)(2)(i) requires an Exchange to obtain sponsored coverage from as many non- compared to FFEs. For example, the FFE data from any electronic data sources Federal and non-SHOP employers as operates Exchanges for 38 States, and that are available to the Exchange and possible. We found that a the volume of employers that the FFE which have been approved by HHS comprehensive database does not encompasses may inherently present based on evidence showing that such currently exist and building such a challenges in relying on sampling data sources are sufficiently current, database would be a resource-intensive results that States may not face. Some accurate, and minimize administrative endeavor. In addition, employers are not States may collect and have access to burden. Paragraph (d)(2)(ii) requires that required to provide information to data from employers that make verifying the Exchange also obtain available data Exchanges or HHS regarding the consumers’ attestations more efficient based on Federal employment through coverage they offer, potentially limiting and reliable, or may have existing HHS, and paragraph (d)(2)(iii) requires the completeness of such a database. channels through which they can the Exchange to obtain available data Because of the current challenges communicate with in-State employers. from the SHOP that corresponds to the associated with building an HHS- Therefore, we proposed to maintain the State in which the Exchange is approved database that is sufficiently option to use sampling as an alternate operating. Under § 155.320(d)(4), if an method of verification under paragraph Exchange is unable to fulfill the 48 81 FR 12203, 12269 (March 8, 2016). (d)(4) to allow SBEs maximum

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flexibility. We stated that we expect that connect, requiring verification through support Exchanges in considering this the proposed change to paragraph (d)(4) SHOP imposes a technical and financial option for verification. to allow Exchanges to continue to use challenge for States that may not be the c. Eligibility Redetermination During a an HHS-approved alternative process to most efficient and cost-effective way to Benefit Year (§ 155.330) sampling through plan year 2019 will perform verification. provide Exchanges with important Additionally, we sought information We sought comment on ways to better flexibility to conduct the most efficient, and suggestions on ways to improve encourage enrollees to report changes in reliable alternate method of verification verification of whether an applicant circumstance occurring during the as Exchanges refine their approaches to reasonably expects to be enrolled in an benefit year that may affect their conducting sampling over time, and eligible employer-sponsored plan or is eligibility for Exchange coverage or for until data sources exist that provide an eligible for qualifying coverage in an APTC or CSRs. The FFEs currently effective way to verify consumers’ eligible employer-sponsored plan for the conduct proactive outreach to enrollees enrollment in or access to qualifying benefit year for which coverage is through a variety of means, including employer-sponsored coverage. If SBEs requested. emails, phone calls, and paper mail, to use an alternative process to sampling to We are finalizing this policy as encourage them to return to the conduct verification under paragraph proposed. Exchange to update their information (d)(4)(ii), the process must be approved Comment: All commenters supported throughout the benefit year and during by HHS. To be approved by HHS, we the proposal to amend § 155.320(d)(4) to key Exchange operational efforts, such expect an Exchange to develop an allow an Exchange to conduct an HHS- as open enrollment. The FFEs also alternate process that provides insight approved alternative process instead of periodically provide general into whether employees provide sampling, as provided under paragraph information and reminders to enrollees. accurate information or the Exchange (d)(4)(ii), for benefit years through 2019. However, many changes in effectively verifies information about Most commenters noted the continued circumstance, such as changes in enrollment in and eligibility for need to perform verification through an household income or size, remain qualifying coverage in an eligible alternate process under paragraph (d)(4), unknown by the Exchanges until employer-sponsored plan.49 This and supported the flexibility to perform reported by the enrollee. requires Exchanges to conduct reliable alternative methods of verification to We are interested in hearing from and sufficient verification, while giving sampling under paragraph (d)(4)(ii). stakeholders about ways to increase them the flexibility to find the most Response: We acknowledge the enrollee reporting of individual changes efficient ways of doing so for their continuing need Exchanges may have to in circumstance within 30 days of the Exchange. use an alternate verification process and change in order to ensure compliance We noted that to the extent an the flexibility to perform an alternative with § 155.330(b). Increasing such Exchange believes an alternate process verification procedure to sampling. We reporting would benefit enrollees by to verification through data sources or are finalizing this provision as ensuring that they continue to be methods other than those described proposed. enrolled based on their current under paragraph (d) may result in a Comment: Most commenters eligibility for financial assistance, and more efficient or comprehensive indicated that challenges remain in would improve program integrity. verification procedure, the Exchange performing verification through some or Comment: Commenters supported may also, in accordance with all of the databases described under finding ways to better encourage §§ 155.315(h) and 155.320(a)(2), request paragraph (d)(2). One commenter Exchange enrollees to report changes in HHS approval for use of an alternate questioned the value of verifying based circumstance during the benefit year so process for verifying enrollment in and on Federal employment data and that they receive updated eligibility access to employer-sponsored coverage. through data based on the State’s SHOP determinations, including with respect We noted that HHS received support for Exchange due to the low number of to any APTC they are receiving. providing flexibility for the use of applicants offered eligible coverage from Commenters acknowledged the benefit alternate data sources by Exchanges in those sources in the relevant State. of timely updates to an enrollee’s comments to the Request for Several commenters supported the household income or family size as a Information. For example, we received flexibility provided under § 155.315(h) way to help minimize any large APTC comments indicating that, for some for Exchanges to request HHS approval reconciliation payments due to the Exchanges, due to the limited number of to perform verification through data Federal government upon filing a Federal employees in their State, sources or methods other than those Federal income tax return. Commenters connecting to the database containing specified in paragraph (d) where an also acknowledged the benefit to the data on Federal employment provides Exchange believes alternate data sources program integrity of the Exchanges, so little utility in Exchange verification of or methods may result in a more that they may continue to have updated applicants’ eligibility for employer- efficient verification procedure for that and accurate enrollee information, as sponsored coverage. One commenter Exchange. well as the benefit to the Federal encouraged HHS to consider removing Response: We agree that challenges government to minimize the amount of the regulatory requirement to connect to remain to performing verification financial assistance being paid on behalf this database for purposes of employer- through databases described under of enrollees who are not eligible (or are sponsored coverage verification. We paragraph (d)(2), and that an Exchange eligible for a lesser amount). have also received feedback from some may believe verification through Commenters recommended increasing Exchanges noting challenges and alternate data sources would be a more Exchange outreach efforts, through mail, limitations connecting to a SHOP appropriate method of verification for email, and social media networks, to database. These Exchanges noted that, their Exchange. While we believe that periodically remind consumers to report given the limited enrollment in SHOP in verification through databases described any life changes that may have many States and that many States do not under paragraph (d)(2) remains a viable occurred. One commenter have a SHOP database with which to option for some Exchanges, we continue recommended that Exchanges use more to provide Exchanges the flexibility distinct envelopes when an enrollee 49 81 FR 94058, 94125 (December 22, 2016). afforded under § 155.315(h), and action is required to improve the rate at

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which these mailings are recognized, period accurately balances the situation is akin to when an enrollee read, and acted upon. Commenters Exchanges’ need for updated adds a new dependent to their coverage, acknowledged the benefit of personal information with the consumer burden even though in this situation the interactions as a way to encourage of actively authorizing Exchanges to dependent is qualifying for a different consumer behavior and recommended access this information. One commenter special enrollment period. that Exchanges engage Navigators who recommended that we consider Proposed new paragraph (a)(4)(iii)(A) have personal relationships with many extending the authorization period past would address the coverage options Exchange enrollees to keep in contact 5 years, and another recommended that available to current enrollees and with the enrollees throughout the year Exchanges be able to access this dependents who qualify for a special and remind them that they should information indefinitely. In addition, enrollment period. As is current policy timely report changes in circumstance several commenters questioned how under paragraph (a)(4)(iii), paragraph to the Exchange. shortening this authorization window (a)(4)(iii)(A) would continue to allow Commenters recommended that would improve Exchange program enrollees and their dependents who Exchanges make it easier for enrollees to integrity. qualify for the special enrollment report changes in circumstance online. Response: We appreciate the periods specified in paragraphs (d), One State Exchange stated they have comments and will take them into other than those described in information about reporting changes in consideration in future rulemaking. paragraphs (d)(2)(i), (d)(4), (d)(6)(i) or circumstance on the main page of their (ii) for becoming newly eligible for 5. Exchange Functions in the Individual Exchange website outside of open CSRs, (d)(8), (d)(9), and (d)(10) of this Market: Enrollment in Qualified Health enrollment, and that enrollees are asked section, to use their special enrollment Plans about whether they need to report a period to change to another QHP within change either over the phone if they call a. Special Enrollment Periods the same level of coverage or one metal the Exchange call center, or online upon (§ 155.420) level higher or lower, if no such QHP is logging into their Exchange accounts. i. Plan Options Under Select Special available, as outlined in § 156.140(b) of Response: We appreciate comments Enrollment Periods this subchapter. received on this topic and will take Proposed new paragraph (a)(4)(iii)(B) them into consideration for FFE For many special enrollment periods, would address the coverage options operations and possibly in future a dependent of an Exchange enrollee available when only a dependent who is rulemaking. may newly enroll in Exchange coverage not currently enrolled in Exchange or switch Exchange plans when the coverage qualifies for a special d. Annual Eligibility Redetermination dependent or another qualified enrollment period. We proposed to (§ 155.335) individual on the Exchange application revise the policy for these qualified We are considering the possibility of qualifies for a special enrollment period. individuals to align with paragraph amending the length of time that Even though dependents may access (a)(4)(i) of this section. We proposed individuals may authorize the special enrollment periods based on that, if a new dependent qualifies for Exchanges to obtain the updated tax different qualifying events, when they one of the special enrollment periods return information for enrollees as qualify for a special enrollment period specified in paragraphs (d)(1), (d)(3), described in § 155.335(k)(2). Currently, to newly enroll in Exchange coverage, (d)(6)(iii), (d)(6)(iv), (d)(7), (d)(11), and the Exchanges may obtain updated tax regardless of whether it is a special (d)(13) of this section and an enrollee return information for a period of no enrollment period due to gaining or would like to add the dependent to his more than 5 years based on a single becoming a dependent or due to a loss or her QHP at that time, the Exchange authorization. of minimum essential coverage, we must allow the enrollee to add the We sought comment on whether 5 believe that they should be treated alike. dependent to his or her current QHP; or, years is an appropriate duration for this Section 155.420(a)(4) defines the if the plan’s business rules do not allow type of an authorization, or whether a coverage changes Exchange enrollees the dependent to enroll, the Exchange shorter time period should be may make when they or their must allow the enrollee and dependent considered. In particular, we are dependents qualify for special to change to another QHP within the contemplating whether shortening this enrollment periods. We proposed to same level of coverage; or, if no such authorization period would improve modify how paragraph (a)(4)(iii) treats QHP is available, allow them to switch Exchange program integrity by helping dependents to align more closely with to a QHP one metal level lower or to ensure that the enrollee’s application paragraph (a)(4)(i) which addresses higher, as outlined in § 156.140(b) of at the time of re-enrollment accurately when an existing enrollee gains a new this subchapter. Alternatively, the reflects his or her data collection dependent. To do this, we proposed to enrollee may enroll the dependent in a preferences, that all sources of income modify paragraph (a)(4)(iii) to establish separate QHP at any metal level. that may affect his or her eligibility for a distinction between how the rule We believe that these modifications APTC and cost-sharing reductions are treats existing enrollees who qualify for are needed in order to align the listed on the application, and that one of the relevant special enrollment flexibilities available to enrollees and individuals update their applications on periods themselves or when existing dependents when a dependent is newly a more regular basis to reflect other Exchange enrollees themselves and their enrolling in Exchange coverage during changes in circumstances that affect dependent(s) qualify for one of the the benefit year due to qualifying for a eligibility (such as changes in relevant special enrollment periods; and special enrollment period. With this employment or marital status). when only new dependents qualify for proposed change, regardless of the Comment: Many commenters opposed one of the relevant special enrollment special enrollment period for which a changing the length of time that periods and are enrolling in coverage dependent qualifies, an enrollee may individuals may authorize Exchanges to with an existing Exchange enrollee. We either add the dependent to his or her obtain their updated tax information. proposed to establish this distinction by existing QHP, as long as he or she Many commenters agreed that 5 years is separating these situations into new continues to qualify for it, or enroll the the appropriate length of time for this paragraphs (a)(4)(iii)(A) and new dependent in a separate QHP at any type of authorization, and that this (a)(4)(iii)(B). We believe the latter metal level.

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In the event that both the enrollee and paragraph (d)(1) of this section and for it is appropriate for States to take the new dependent qualify for special being determined ineligible for additional time, as needed, in order to enrollment periods referenced in Medicaid or the Children’s Health comply with this change. proposed paragraphs (a)(4)(iii)(A) and Insurance Program, may similarly Lastly, as we noted in the 2017 (a)(4)(iii)(B), respectively, and the change a household’s health care needs Market Stabilization Rule, we enrollee wants to add this new if, for example, dependents had been considered the concerns regarding dependent to his or her QHP, the previously enrolled in Medicaid or conflicts of this policy with the statute, Exchange would allow both the enrollee CHIP and are losing that coverage for but believe that limiting enrollees’ and dependent to switch to a new QHP the first time. ability to change QHPs or metal levels at the same metal level, if available, as Several commenters expressed is consistent with the requirements in described in proposed paragraph concern about the technical impact the section 1311(c)(6)(C) of the PPACA (a)(4)(iii)(A). proposed changes would have on State directing the Secretary to require We are finalizing this policy as Exchanges, especially those States that Exchanges to establish special proposed. had already been working toward enrollment periods as specified in Comment: The majority of implementing the plan option section 9801 of the Code and under commenters supported the proposal to restrictions as finalized in the 2017 circumstances similar to such periods align plan options for a dependent of an Market Stabilization Rule. States under Part D of title XVIII of the Act, as Exchange enrollee who qualifies for a cautioned that finalizing this proposal well as the Secretary’s authority under special enrollment period to newly would delay their ability to implement section 2702(b)(3) of the PHS Act to enroll in Exchange coverage along with this policy and several States requested promulgate regulations for the the existing Exchange enrollee, State flexibility with respect to this individual market with respect to regardless of the special enrollment proposal. special enrollment periods for period the dependent qualifies for, Other commenters expressed qualifying events under section 603 of thereby aligning the dependent policies opposition to this proposed change the Employee Retirement Income in paragraphs (a)(4)(i) and (a)(4)(iii)(B). because it would further restrict plan Security Act of 1974. Given that the Commenters appreciated the options available to enrollees and PPACA itself called for one annual open simplification of plan option rules for dependents newly enrolling in QHP enrollment period and additional enrollees who seek to newly enroll a coverage. These commenters stated that enrollment opportunities only in the dependent in Exchange coverage after imposing restrictions of individuals’ case of special circumstances, we that dependent has qualified for a choice of QHPs to enroll in after he or believe it is reasonable to interpret the special enrollment period, and stated she qualifies for a special enrollment special enrollment period and that this simplification will benefit period contradicts the intent of special guaranteed issue provisions of the Exchange enrollees, as well as those enrollment periods. One commenter PPACA in this manner. providing enrollment assistance, such as stated that limiting plan options for We proposed to exclude the special Navigators, agents, and brokers, by enrollees or dependents upon qualifying enrollment period in paragraph (d)(12) making it easier for them to understand for a special enrollment period is for material plan or benefit display and explain the enrollee’s enrollment prohibited by the guaranteed issue errors from paragraph (a)(4)(iii). This is options. In addition, some commenters provision of the PPACA statute. The because we understand that certain supported aligning the plan option rules guaranteed issue provision requires that material plan or benefit display errors out of fairness, to ensure that all issuers accept every individual in the may impact an enrollees’ decision to similarly situated dependents who are State who applies for such coverage enroll in a level of coverage, in addition newly enrolling in Exchange coverage and, while issuers may restrict to his or her decision to enroll in a should have the same enrollment enrollment periods, they stated, specific QHP. Therefore, we believe options available to them. restrictions on the type of plan the that, if an enrollee qualifies for the A few commenters supported this individual enrolls in is not permitted. special enrollment period because of a proposal, but also requested that Response: We agree that there is a material plan or benefit display error, he changes to the plan option restrictions benefit to aligning the plan options or she should be allowed to switch to in paragraph (a)(4) be amended to give available to enrollees who are adding a a different QHP at any metal level that affected enrollees and dependents the dependent newly enrolling in Exchange better meets his or her needs. option to enroll in a QHP at a lower coverage through a special enrollment We are finalizing the policy as level of coverage, alongside the option period. We appreciate commenters’ proposed. to enroll in either the same QHP or concerns about the impact household Comment: Commenters supported the another QHP at the same level of changes may have on a family’s health proposal to exempt from the plan option coverage, as applicable. Commenters coverage needs, but believe that restrictions in paragraph (a)(4)(iii) the stated that this increased flexibility is maintaining these restrictions is special enrollment period in paragraph especially necessary for situations necessary in order to continue to avoid (d)(12) for when a qualified individual, where enrollees are gaining or become adverse selection. We continue to enrollee, or his or her dependent a new dependent, in accordance with encourage enrollees to explore all adequately demonstrates to the paragraph (d)(2)(i) of this section, available QHPs during open enrollment, Exchange that a material error related to because changes in household and to change plans if another QHP plan benefits, service area, or premium composition, especially the addition of better meets their or their family’s influenced the qualified individual’s or a new infant or child to a household, needs. enrollee’s decision to purchase a QHP likely change a household’s health care We understand that the proposed through the Exchange. Such a material needs and what level of coverage is best changes may delay State Exchanges’ plan error may have impacted not only suited to meet those needs. Other ability to implement the plan option the specific QHP an individual enrolled special enrollment periods included in restrictions, especially in those States in, but also the level of coverage the paragraph (a)(4)(iii)(B), such as the where this proposal will require a individual decided to purchase. One special enrollment periods for loss of change to Exchange system commenter requested that we provide minimum essential coverage in functionality, and, therefore, we believe additional guidance regarding the types

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of errors that we would consider the 60 days prior to the date of their exception, in particular that a person material for purposes of being excluded qualifying event, they lived in a service only have lived for 1 of the 60 days from the plan option restrictions in area where there were no QHPs offered prior to their qualifying event in a paragraph (a)(4)(iii). through an Exchange. Absent this service area where there were no QHPs Response: We are finalizing this change, qualified individuals who have offered through an Exchange, was not policy as proposed. We also clarify that, lived for part of the benefit year in a stringent enough. This commenter while we are finalizing an amendment location where no QHPs were offered suggested that such a brief residency to exempt this special enrollment period through an Exchange, and, therefore, requirement could lead individuals to from the plan option restrictions in may have been unable to enroll in move to an affected service area on a paragraph (a)(4)(iii), we are not minimum essential coverage, would be transitional basis in order to avoid the amending the criteria for qualifying for prevented from subsequently qualifying prior coverage requirement. To reduce the special enrollment period in for a special enrollment period due to a the likelihood that individuals who did paragraph (d)(12), which is intended for permanent move or marriage. not qualify would be able to take when an enrollee adequately Additionally, we noted that the advantage of this exception, the demonstrates to the Exchange that a proposed amendment to paragraph commenter recommended that we material error related to plan benefits, (a)(5) would apply, along with the rest require individuals to have been service area, or premium influenced the of the paragraph, to the individual residents in a service area without QHPs qualified individual’s or enrollee’s market outside of the Exchange through for the entire 60 day period prior to decision to purchase a QHP through the the cross-reference to § 155.420(d) in their qualifying event. Exchange and refer the commenter to § 147.104(b)(2). In this context, health Response: We will consider the preamble discussion of the 2018 insurance issuers offering coverage publishing a list of service areas in Payment Notice where we discuss this outside an Exchange would not be able which no QHPs are offered by the special enrollment period. to require qualified individuals to Exchange, so that this exception can be demonstrate prior coverage if they lived applied consistently and accurately off- ii. Exception to Prior Coverage for at least 1 of the 60 days prior to their Exchange. In addition, we may release Requirement for Qualified Individuals qualifying event in a service area where additional guidance if a service area is Who Have Lived in Service Areas there were no QHPs offered through an left without QHP coverage and it Where No QHP Is Offered Through an Exchange. becomes necessary to implement this Exchange We are finalizing the policy as exception. HHS recently added a prior coverage proposed, except that we are amending We understand concerns that requirement to the special enrollment the regulatory text to ensure the individuals may seek to fraudulently period for gaining access to new QHPs exception applies to individuals who claim this exception in order to avoid as a result of a permanent move, lived in a service area where no QHPs the prior coverage requirement, and we described in § 155.420(d)(7), and the were offered through an Exchange remain committed to promoting special enrollment period for gaining or during their most recent Exchange continuity of coverage and ensuring that becoming a dependent through enrollment period, regardless of only eligible consumers may access marriage, described in § 155.420(d)(2)(i). whether that enrollment period was an coverage through special enrollment Section 155.420(a)(5) specifies how a Exchange open enrollment period or a periods. However, we believe that this qualified individual can satisfy the prior special enrollment period. This change exception for individuals who have coverage requirement. Qualified will address situations where no QHPs lived in a service area where no QHPs individuals can demonstrate that they were available to an individual during are offered by the Exchange for at least had minimum essential coverage as their enrollment window, but later 1 of the 60 days before a qualifying described in 26 CFR 1.5000A–1(b) for 1 became available in the individual’s event or during their most recent or more days during the 60 days service area prior to his or her marriage preceding enrollment period is preceding the date of the qualifying or move. important, because it takes into account event; lived in a foreign country or in Comment: Commenters supported the the potential for a service area to a United States territory for 1 or more proposal to exempt qualified temporarily be without a QHP, such as days during the 60 days preceding the individuals from the prior coverage in the case of a temporary QHP date of the qualifying event; or are an requirement if, for at least 1 of the 60 suppression or mid-year QHP Indian, as defined by section 4 of the days prior to the date of their qualifying decertification, and the need to protect Indian Health Care Improvement Act. event, they lived in a service area where individuals who may be affected by this This prior coverage requirement there were no QHPs offered through an lack of availability. Additionally, we encourages individuals to maintain Exchange. Several commenters added note the need to ensure that individuals coverage throughout the year. that HHS should continue to implement are not prevented from accessing However, we recognize that procedures currently in place to verify coverage through a special enrollment individuals living in a service area other aspects of the applicable special period mid-year because of having lived where no Exchange QHPs are offered enrollment period qualifying event, in a service area where no QHPs were may not be able to obtain affordable such as a move, within the required 60- offered through the Exchange during coverage. We believe that individuals in day window. Commenters also their most recent enrollment period this situation should not later be requested, if this exception to the prior (open enrollment or special enrollment prevented from enrolling in coverage coverage requirement becomes period) when they could have otherwise through a special enrollment period that necessary, that HHS publish a list of enrolled in affordable coverage, even if requires prior coverage when they were service areas in which no QHPs are during the 60 days before a subsequent previously unable to enroll in Exchange offered through an Exchange, in part to qualifying event a QHP is available in coverage because it was unavailable or ensure that issuers can apply the their service area. Therefore, we are inaccessible. Therefore, we proposed to exception accurately in the off-Exchange finalizing this exception to the prior amend paragraph (a)(5) to exempt individual market. coverage requirement that currently qualified individuals from the prior One commenter raised the concern applies to certain special enrollment coverage requirement if, for at least 1 of that our proposed criteria for the periods to include consumers who lived

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in a service area where no QHP was enrollment period for a court order and updating their systems to reflect new available through the Exchange during redesignate current paragraph (b)(2)(vi) effective date options in States that offer their most recent preceding enrollment as paragraph (b)(2)(v). These revisions this optional alternate coverage effective period. would align the coverage effective dates date option to consumers, and limit We also note that concerns that for all special enrollment periods based individuals’ access to retroactive individuals will fraudulently claim on gaining or becoming a dependent, coverage options. eligibility for an exception to the prior with the exception of gaining or Response: We agree that these coverage requirement are addressed in becoming a dependent through changes will promote the goals of part because the FFE will continue to marriage. Aligning coverage effective providing the same alternate coverage require document-based verification of date options ensures that Exchanges the individual’s eligibility for the provide qualified individuals in similar effective date options to consumers who special enrollment period and, in order situations with the same flexibility with qualify for a special enrollment period to qualify for the special enrollment regard to coverage effective dates. due to gaining or becoming a dependent period due to a permanent move, We also proposed to modify through a birth, adoption, foster care individuals will continue to be required paragraph (b)(2)(i) so that, in addition to placement, or court order, and of to meet the residency requirements for requiring an Exchange to ensure that streamlining Exchange operations by their new and former addresses, in coverage is effective retroactive to the revising the ‘‘first of the month’’ accordance with § 155.305(a)(3) and as date of the qualifying event, it may coverage effective date option so that it explained in the January 2016 FAQs on permit the qualified individual or can be operationalized in the same way the Marketplace Residency Requirement enrollee to elect a coverage effective for all special enrollment periods for and the Special Enrollment Period due date of the first of the month following which it is an option. We note that this to a Permanent Move.50 Finally, we plan selection, rather than the first of proposal does not remove or alter the anticipate that this exception will be the month following the qualifying requirement at § 155.420(b)(2) that granted extremely rarely, which event, as currently written, or following Exchanges ensure that coverage is minimizes the risk that it will be used regular coverage effective dates, in effective retroactive to the date of the inappropriately. accordance with paragraph (b)(1) of this qualifying event for consumers who section. This amendment would qualify for a special enrollment period iii. Effective Date Options for Special streamline Exchange operations and due to gaining or becoming a dependent Enrollment Periods Relating To Gaining align this coverage effective date option through a birth, adoption, foster care or Becoming a Dependent with the accelerated prospective placement, or court order. coverage effective date rule as it applies Paragraph (b)(2)(i) of § 155.420 We acknowledge that allowing requires Exchanges to provide to other special enrollment periods, Exchanges to permit individuals to elect individuals who qualify for a special including the special enrollment period that their coverage take effect on the enrollment period due to gaining or for gaining or becoming a dependent first of the month following plan becoming a dependent through birth, through marriage, as described in selection instead of on the first of the adoption, placement for adoption, or (b)(2)(ii) of this section. month after the date of their qualifying placement in foster care, as described in Therefore, individuals who qualify for paragraph (d)(2)(i), with a retroactive a special enrollment period due to event will mean that consumers only coverage effective date back to the date gaining or becoming a dependent have one option for their coverage to of the qualifying event. It also gives through birth, adoption, placement for take effect retroactively—back to the Exchanges the option to allow these adoption, or placement in foster care, or date of their qualifying event—whereas consumers to elect an effective date of through a child support or other court prior to the change, they could request the first of the month following the date order, will be able to elect from the that coverage take effect retroactive to of the event or following regular same alternate coverage effective date the first of the month after their coverage effective dates, in accordance options, if offered by their Exchange. qualifying event if their Exchange with paragraph (b)(1) of this section. We are finalizing this policy as allowed this option. However, we also Paragraph (b)(2)(v) addresses coverage proposed. note that the proposed change adds an Comment: Commenters supported the effective date options for special accelerated prospective option that is proposal to align the coverage effective enrollment periods related to gaining or not currently available to these date options for those who gain or becoming a dependent due to a child consumers. become a dependent through birth, support or other court order, as also adoption, or foster care placement with Additionally, we believe that, while described in paragraph (d)(2)(i). It those who gain or become a dependent some Exchanges may need to make requires Exchanges to ensure that through a child support or other court system updates based on this change, coverage takes effect on the date of the order. Commenters agreed that aligning they will have the flexibility that they court order, and it permits Exchanges to special enrollment period coverage need in order to manage the potential allow qualified individuals to elect an effective date options for most situations impact because Exchanges are not effective date based on paragraph (b)(1). where individuals are gaining or required to offer these alternate coverage However, it does not provide Exchanges becoming a dependent would result in effective date options and may delay with the option to allow qualified a simpler rule and more intuitive implementation if necessary. Finally, individuals to elect that their coverage operational processes, both reducing the alignment of this effective date begin the first of the month following administrative burden on issuers and on option with the ‘‘first of the month’’ the date of the event. agents and brokers and helping effective date that also applies to other We proposed to remove paragraph individuals better understand their types of special enrollment periods (in (b)(2)(v) of this section and to revise coverage effective date options. One particular the special enrollment period paragraph (b)(2)(i) to include the special commenter opposed this proposal due due to gaining or becoming a dependent through a marriage), will also likely 50 Available at https://www.regtap.info/uploads/ to concerns that it would reduce State library/ENR_FAQ_ResidencyPermanentMove_SEP_ flexibility, could increase burden on generate efficiencies for Exchanges in 5CR_011916.pdf. Exchanges due to costs associated with the long term.

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iv. Loss of Coverage Special Enrollment the option of the Exchange, as provided is determined eligible for Medicaid, Period (§ 155.420(d)(1)(iii)) under paragraph (b)(2)(iv). We believe CHIP, or BHP. Section 155.420(d)(1) establishes a that this revision is needed to ensure a We proposed to remove paragraphs special enrollment period for qualified pathway to coverage for women in the (d)(1)(i) and (d)(2)(i) through (d)(2)(iii) to align the effective dates for all individuals who lose certain types of 17 States that offer unborn child CHIP enrollee-initiated terminations on the coverage, including minimum essential coverage, so that they may maintain date on which the termination is coverage. As described in paragraph access to continuous coverage after the requested by the enrollee or on another (d)(1)(iii), qualified individuals who birth of their child. We are finalizing this policy as prospective date selected by the lose certain types of Medicaid proposed. enrollee. We also proposed removing pregnancy-related coverage not Comment: We received overwhelming existing paragraph (d)(2)(iv), which considered minimum essential coverage support for this proposal; commenters states that the QHP termination date for may also qualify for this special did not raise any concerns, and noted an enrollee newly determined eligible enrollment period. This is to ensure that that it would help streamline Exchange for Medicaid, CHIP or a BHP is the date women losing eligibility for coverage of operations and ensure that women before the Medicaid, CHIP, or BHP pregnancy-related services that often losing access to CHIP coverage for their eligibility determination. We invited meet their primary and specialty health unborn child are able to maintain comment from Exchanges, issuers, and care needs are not left without the continuous coverage. other stakeholders on any burdens these option to enroll in a QHP through an Response: We are finalizing this rule changes may impose, as well as Exchange after they lose access to those provision as proposed. whether we should make the changes at services. iv. Technical Amendment the option of the Exchange or the issuer. We proposed to revise paragraph We are not finalizing this policy as (§ 155.420(d)(10)(i)) (d)(1)(iii) to include women who lose proposed. Rather, we are restructuring access to health care services that they We proposed to make a technical paragraph (d)(2) to improve its were receiving through CHIP coverage amendment to update the cross readability, and, in response to for their unborn child. While CHIP reference to 26 CFR 1.36B–2T in comments from Exchanges responding coverage for unborn children, provided § 155.420(d)(10)(i), regarding the special to our solicitation of comments, based on the definition of a child enrollment period for victims of providing additional flexibility to allow described in 42 CFR 457.10, is domestic abuse or spousal Exchanges to retain the current policy or considered minimum essential coverage abandonment. The temporary regulation operate under the proposed policy. for the unborn child, it is not considered under section 36B of the Code originally Comment: Supporters of our proposal minimum essential coverage for the cited has now been finalized without to eliminate the ‘‘reasonable notice’’ pregnant woman. Nonetheless, these change to the definition cited in this requirement referenced the more pregnant women may receive a set of special enrollment period. This streamlined and straightforward health services comparable to those technical correction would not alter the approach to terminations for consumers available to women enrolled in parameters of this special enrollment and its ability to reduce duplicate or Medicaid pregnancy-related coverage. period. overlapping coverage when enrollees For this reason, pregnant women who Commenters supported this proposal; obtain other coverage. Many supporters have received prenatal care as part of we are finalizing this change as cited challenges consumers face CHIP coverage for their unborn child proposed. transitioning into Medicare and stated may apply and be determined eligible that being able to choose the date of b. Effective Dates for Terminations for a hardship exemption from the FFEs their QHP termination would alleviate (§ 155.430) so that they are not required to also the need to reach out to the Exchange maintain minimum essential coverage Section 155.430 specifies the multiple times to ensure the proper during that time. termination dates for Exchange termination date to avoid having dual The proposed revision to paragraph enrollees. Paragraph (d)(1)(i) of coverage. (d)(1)(iii) would provide a pathway to § 155.430 defines ‘‘reasonable notice’’ as Response: We agree that allowing coverage for new mothers who lose at least 14 days before the requested enrollees to terminate their coverage access to health care services provided effective date of termination. Paragraph immediately or on a future date of their through unborn child CHIP coverage (d)(2) sets forth three possible effective choosing will provide consumers with following the birth of their child, and dates for enrollee-initiated terminations greater control over ending their QHP who are otherwise eligible to enroll in made in accordance with paragraph coverage and will help minimize or a QHP through the Exchange. Under (b)(1): (1) The termination date specified eliminate overlaps in coverage, for paragraph (c)(2) of this section, these by the enrollee, if the enrollee provides example, when aging into Medicare. qualified individuals would have up to reasonable notice; (2) 14 days after the Such flexibility will also allow 60 days before or after the loss of access termination is requested by the enrollee, Exchanges to send termination to CHIP unborn child coverage to if the enrollee does not provide transactions to issuers that do not need qualify for the loss of coverage special reasonable notice; or (3) on a date on or subsequent adjustment, reducing the enrollment period and enroll in a QHP. after the date on which the termination need for casework or direct consumer If they select a plan prior to their loss is requested by the enrollee, if the contact with issuers to request of CHIP unborn child coverage, their enrollee’s QHP issuer agrees to termination dates to effectuate in less Exchange coverage would begin as soon effectuate termination in fewer than 14 than 14 days. as the first day of the month following days, and the enrollee requests an Comment: Some commenters the loss of coverage. If they select a plan earlier termination effective date. requested that we provide flexibility in after the loss of CHIP unborn child Further, current paragraph (d)(2)(iv) sets the implementation of this rule, citing coverage, their Exchange coverage the QHP termination effective date for technical and operational challenges would begin either the first of the enrollees newly eligible for Medicaid, with premium proration, in addition to following month or following regular, CHIP, or the Basic Health Program the common consumer desire to prospective coverage effective dates at (BHP) as the day before the individual terminate plans at the end of the month.

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Response: We acknowledge that not A few commenters encouraged costs for consumers. Finally, we agree all Exchanges have the same system flexibility to maintain existing policy that automatic transition from QHP capabilities, and are providing and business operations, and others coverage to Medicaid/CHIP/BHP Exchanges flexibility to implement this encouraged HHS to allow States to coverage without consumer intervention change at their discretion. determine how the change would is a worthy goal, but we recognize that Comment: Several commenters impact their populations, given their many Exchanges do not have real-time opposed the rule, stating that 14 days is Medicaid eligibility processing times, as coordination with their Medicaid/CHIP/ a reasonable industry practice for well as their ability to reach and inform BHP agencies in order to do so. issuers, while others expressed concerns consumers about their need to take Comment: A few commenters that same-day terminations are not action. expressed concerns about possible feasible for issuer processing, due to the Response: We agree that the current downstream effects on eligibility for timing of Exchange-sent 834 Medicaid/CHIP/BHP rule causes transactions. Some urged HHS to work unnecessary confusion, given that we do future QHP coverage from putting the with issuers to determine a more not provide QHP termination dates full responsibility for QHP termination realistic timeframe—ranging from next- according to eligibility for other forms of on the Medicaid/CHIP/BHP consumer. day to 5 days—and implement a default coverage, such as Medicare or employer- For example, if a consumer fails to end-of-month termination effective date. sponsored coverage. We also recognize terminate QHP coverage for which One commenter discussed the that eligibility determinations APTC are paid, he may stop paying importance of coordination between conducted through the State Medicaid premiums because he is enrolled in issuers and Exchanges to synchronize agency, instead of the Exchange, can Medicaid and the issuer will terminate enrollment and termination effective result in challenges coordinating his coverage for nonpayment. At the end dates to reduce adverse downstream effective dates through the State agency, of the grace period, he will still owe effects on payment reconciliation the Exchange, and its issuers; and can premium for one month of coverage processes. result in consumer complaints and after the Medicaid determination.51 Response: Issuers already process a subsequent casework. We recognize Under certain circumstances set forth in significant number of same-day issuer challenges with retroactive the Market Stabilization final rule,52 the terminations when removing less than terminations and appreciate willingness QHP issuer could then attribute the whole enrollment group from QHP to process limited retroactive payments made toward subsequent coverage, and they have reported no terminations. However, because we enrollments to the premium amount difficulties in doing so. While we expect recognize that Exchanges’ coordination owed, and deny enrollment in the new with their Medicaid and CHIP programs the vast majority of enrollees will want coverage for failure to pay the binder varies, we are providing Exchanges their coverage to end at the end of payment. In regions with only one flexibility to implement this change at month, this option for a more precise issuer, this could leave consumers who their discretion. termination date is necessary for Comment: Most commenters who rise above the Medicaid income consumers because retroactive opposed the proposal to remove the threshold without access to coverage terminations are only available in very Medicaid/CHIP/BHP rule cited adverse options. limited circumstances. consumer impact, and were primarily Response: We acknowledge there may Comment: One commenter urged us concerned about placing the burden to be downstream effects on eligibility for to allow issuers to transmit 834 files to terminate QHP coverage on the future QHP coverage due to non- the Exchange with consumer-initiated Medicaid/CHIP/BHP enrollee who may payment of premiums for those who do terminations, stating that most not understand the need to terminate. not terminate their coverage timely and consumers notify their issuers first One commenter stated it was important enter a grace period. The FFEs continue when terminating coverage. for QHP enrollees to continue to be able to make IT improvements and enhance Response: We recognize that many to recoup premium payments made consumer education and outreach with enrollees reach out to their issuers to when in fact eligible for Medicaid due the purpose of making it easier and initiate terminations. However, to Medicaid’s 90-day retroactive clearer for an individual to terminate terminations must be triggered through eligibility rules. Others stated that the QHP coverage in a timely manner. the Exchange so enrollees remaining on QHP should terminate automatically the application can receive an updated with Medicaid eligibility. 6. Definitions (§ 155.500) eligibility determination. Response: We recognize there may be Comment: Supporters of the proposal some consumer impacts with the This section defines terms that are to remove the current Medicaid/CHIP/ implementation of this rule. We also relevant to this subpart. We proposed to BHP termination rule—which allows for recognize that the removal of this rule amend the definitions of ‘‘Appeal retroactive QHP terminations based on may limit enrollees’ ability to request’’ and ‘‘Appeals entity’’ by new Medicaid/CHIP/BHP eligibility retroactively terminate QHP coverage adding a cross reference to proposed determinations—described the current when it overlaps with Medicaid/CHIP/ section § 155.716(e)’’ to align with other rule as a source of confusion for issuers, BHP coverage, which could result in proposals discussed throughout the States, Exchanges and consumers, and consumers being unable to recoup proposed rule, and finalized in this rule, noted challenges coordinating with premiums paid for periods when the regarding SHOP. We did not receive State Medicaid agencies, as well as the enrollee was enrolled in QHP coverage substantive comments specific to this volume of complex casework the rule through the Exchange and gains proposal, and are finalizing as proposed. currently triggers. One commenter retroactive eligibility for Medicaid/ recommended that HHS permit CHIP/BHP. However, these types of 51 This grace period only applies to APTC retroactive QHP terminations if the retroactive terminations can lead to recipients. Termination rules for non-payment of Medicaid, CHIP or BHP determination major challenges for consumers as premium default to State law for non-financial assistance enrollees, for whom the last day of was less than 30 days in the past Medicaid/CHIP/BHP providers may not coverage is generally the last day of the month in because it is more difficult for plans to cover claims reversed by the QHP— good standing. reverse claims after 30 days. leading to unexpected out-of-pocket 52 82 FR 18349–18353.

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7. Eligibility Standards for Exemptions individuals may lack access to under § 155.605(d)(2)(iv), certain (§ 155.605) affordable coverage, but be unable to employed individuals are exempt if, on a. Hardship Exemptions (§ 155.605(d)) qualify for an exemption determination an individual basis, the cost of self-only from the Exchange due to the coverage is less than the required Section 1311(d)(4)(H) of the PPACA Exchange’s inability to calculate contribution percentage, but the and section 5000A(e)(5) of the Code whether coverage is unaffordable due to aggregate cost of individual coverage allow individuals to seek an exemption the absence of a bronze plan in that through employers exceeds the required from the individual shared county. Under the proposed amendment contribution percentage and no family responsibility provision due to a lack of to § 155.605(d)(2), Exchanges would use coverage is available through an affordable coverage based on an the amount of the lowest cost Exchange employer at a cost less than the required individual’s projected income. Although metal level plan available to the contribution percentage. Although tax tax reform legislation enacted in individual when no bronze level plan is reform legislation enacted in December December 2017 reduces to $0 the available. 2017 reduces to $0 the individual individual shared responsibility Comment: All commenters supported shared responsibility payment for payment for months beginning after the proposed change to use the lowest months beginning after December 31, December 31, 2018, individuals may cost metal level plan when calculating 2018, individuals may continue to seek still have a need to seek a hardship whether a plan is affordable in the a hardship exemption based on the exemption for 2019 and future years due instances when no bronze plan is required contribution amount after 2018 to a lack of affordable coverage based on available. Commenters suggested that to obtain catastrophic coverage. Further, projected income. For example, the regulatory text clarify that the the excess of the rate of premium individuals may continue to seek a determination of the lowest-cost plan is growth over the rate of income growth hardship exemption after 2018 to be made at the county level rather than the also is used for determining the eligible for catastrophic coverage. rating area level, and that the applicable percentage in section Section 155.605(d)(2) establishes the determination of the ‘‘lowest-cost circumstances under which an 36B(b)(3)(A) of the Code and the Exchange plan’’ on which to base required contribution percentage in Exchange must determine an applicant eligibility for an exemption should be eligible for an exemption due to lack of section 36B(c)(2)(C) of the Code. As made without consideration of such, we are continuing to finalize the affordable coverage based on projected catastrophic plans. Some commenters income. For determining whether excess of the rate of premium growth supported the proposal, but asked that over the rate of income growth and the affordable coverage is available, the exemption not be interpreted paragraph (d)(2) states that the Exchange required contribution percentage for the broadly so that the exemption would 2019 benefit year below. should use the standards specified in weaken the risk pool. One commenter section 5000A(e)(1) of the Code that, Section 5000A of the Code established recommended that HHS bring forward the 2014 required contribution among other things, specify that the the effective date of the rule to plan year Exchange should use, for individuals percentage at 8 percent. For plan years 2018. after 2014, section 5000A(e)(1)(D) of the not eligible for employer-sponsored Response: We are finalizing this Code and 26 CFR 1.5000A–3(e)(2)(ii) coverage, the annual premium for the policy, and are clarifying that eligibility provide that the required contribution lowest-cost bronze plan available in the for an exemption should be made at the individual market through the Exchange county level and without consideration percentage is the percentage determined in the State in the county in which the of catastrophic plans. We appreciate the by the Secretary of HHS that reflects the individual resides. concerns about the risk pool, but believe excess of the rate of premium growth However, market instability has that this change is targeted specifically between the preceding calendar year resulted in limited offerings of plans on to handle the issue of when no bronze and 2013, over the rate of income the Exchanges in many regions, and plans are available to the individual. growth for that period. there may be individuals who live in a This change will be effective on the We established a methodology for county without a bronze plan. Under effective date of this rule, which occurs determining the excess of the rate of the current regulation, the Exchange during the 2018 plan year. premium growth over the rate of income would not be able to make a growth for plan years after 2014 in the determination as to whether an b. Required Contribution Percentage 2015 Market Standards Rule (79 FR individual not eligible for employer- (§ 155.605(e)(3)) 30302), and we stated that future sponsored coverage who lives in a rating Under section 5000A of the Code, an adjustments would be published area without a bronze plan is eligible for individual must have minimum annually in the HHS notice of benefit the exemption due to lack of affordable essential coverage for each month, and payment parameters. coverage based on projected income. We qualify for an exemption, or make an Under the HHS methodology, the rate proposed to amend paragraph individual shared responsibility of premium growth over the rate of § 155.605(d)(2)(iv), to allow an payment. Under section 5000A(e)(1) of income growth for a particular calendar Exchange to make a determination of the Code, an individual is exempt if the year is the quotient of (x) 1 plus the rate lack of affordable coverage based on amount that he or she would be of premium growth between the projected income for individuals not required to pay for minimum essential preceding calendar year and 2013, eligible for employer-sponsored coverage (the required contribution) carried out to ten significant digits, coverage using the annual premium for exceeds a particular percentage (the divided by (y) 1 plus the rate of income the lowest cost Exchange metal level required contribution percentage) of his growth between the preceding calendar plan, excluding catastrophic plans, or her actual household income for a year and 2013, carried out to ten available in the individual market taxable year. In addition, under significant digits.53 through the Exchange in the State in the § 155.605(d)(2), an individual is exempt county in which the individual resides if his or her required contribution 53 We also defined the required contribution percentage at § 155.600(a) to mean the product of if there is no bronze level plan sold exceeds the required contribution 8 percent and the rate of premium growth over the through the Exchange in that county. percentage of his or her projected rate of income growth for the calendar year, Absent this proposed change, household income for a year. Finally, Continued

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As the measure of premium growth Comment: We received no comments order to participate in an FFE. As a for a calendar year, we established in on other measures of premium growth result, HHS expected a significant the 2015 Market Standards Rule that we or income growth that we could use to decrease in the number of issuers in the would use the premium adjustment calculate the required contribution FF–SHOPs in the 2018 plan year and percentage. The premium adjustment percentage. One commenter supported fewer enrollments in the FF–SHOPs and percentage is based on projections of the current methodology, saying it SBE–FPs for SHOP. With the significant average per enrollee employer- provides consistency and stability, decreases in SHOP QHP issuer sponsored insurance premiums from the given highly volatile premiums. participation and enrollment for plan National Health Expenditure Accounts Response: We are finalizing the year 2018, and, due to lower than (NHEA), which are calculated by the required contribution percentage as expected enrollment in the FF–SHOPs CMS Office of the Actuary.54 (As proposed. and SBE–FPs for SHOP to date, it is not cost effective for the Federal discussed elsewhere in this preamble, 8. Eligibility Process for Exemptions we are finalizing the proposed 2019 government to continue to maintain premium adjustment percentage of Section 155.610(h)(2) describes the certain FF–SHOP functionalities, collect 1.2516634051, (or an increase of about timeframe during which the Exchange significantly reduced user fees on a 25 percent over the period from 2013 to will accept an individual’s application monthly basis, maintain the 2018). This reflects an increase of about for a hardship exemption. We proposed technologies required to maintain an 7.7 percent over the 2018 premium to make a technical correction to FF–SHOP website and payment adjustment percentage (1.2516634051/ § 155.610(h)(2) to reflect the prior platform, generate enrollment and 1.1617303196).) redesignation of paragraph payment transaction files, and perform § 155.605(g)(1), which describes the As the measure of income growth for enrollment reconciliation. criteria for a hardship exemption, to We proposed to remove regulatory a calendar year, we established in the § 155.605(d)(1) in the 2017 Payment burden on SHOPs by removing several 2017 Payment Notice that we would use Notice.55 of the existing requirements imposed per capita personal income (PI). Under Commenters did not oppose this upon the SHOPs, focusing on removing the approach finalized in the 2017 correction, and we are finalizing as requirements to provide certain Payment Notice, and using the NHEA proposed. functionality that is not expressly data, the rate of income growth for 2019 required by the PPACA, while still 9. Exchange Functions: Small Business is the percentage (if any) by which the ensuring appropriate implementation of Health Options Program most recent projection of per capita PI statutorily required functions of the for the preceding calendar year ($53,729 We previously interpreted the SHOP. Under the proposals, employer for 2018) exceeds per capita PI for 2013 PPACA’s provisions regarding the groups that are currently enrolled in a ($44,555), carried out to ten significant SHOPs to require that all SHOPs SHOP QHP for plan years that began digits. The ratio of per capita PI for 2018 provide for employer eligibility, prior to January 1, 2018, would not be over the per capita PI for 2013 is employee eligibility, and certain affected by the proposed changes to estimated to be 1.2059028167 (that is, enrollment functions, including enrollment through a SHOP. We are per capita income growth of about 20.6 premium aggregation functions. generally finalizing this rule as percent). This reflects an increase of As we have stated in previously proposed, and describe changes to about 4.5 percent relative to the increase released guidance,56 the FF–SHOPs and certain of the regulations later in this for 2013 to 2017 (1.2059028167/ the SBE–FPs for SHOPs have seen lower section of the preamble. The changes 1.1540603665) used in the 2019 than expected enrollment, to date. As of will take effect for plan years beginning Payment Notice final rule. January 1, 2017, approximately 7,554 on or after January 1, 2018, as of the Thus, using the 2019 premium employer groups were enrolled in the effective date of this rule. adjustment percentage finalized in this FF–SHOPs, covering 38,749 lives. Under the approach we proposed and rule, the excess of the rate of premium Further, we recognize that many SHOPs, are finalizing, SHOPs will no longer be growth over the rate of income growth including FF–SHOPs, continue to face required to provide employee eligibility, for 2013 to 2018 is 1.2516634051/ challenges and, to accommodate those premium aggregation, and online 1.2059028167, or 1.0379471610. This challenges and to provide SHOPs with enrollment functionality for plan years results in a required contribution more flexibility in operating their beginning on or after January 1, 2018, percentage for 2019 of programs, we proposed to allow SHOPs effective on the effective date of this 8.00 * 1.0379471610 or 8.30 percent, to operate in a leaner fashion beginning rule. The FF–SHOPs, and SBE–FP for when rounded to the nearest one- for plan years beginning on or after SHOPs, will take advantage of these hundredth of one percent, an increase of January 1, 2018. We are generally flexibilities. Despite the removal of 0.25 percentage point from 2018 finalizing the policies as proposed, and several regulations on SHOPs, State (8.30358–8.05317). describe changes to certain of the Exchanges will continue to have the We sought comment on whether there regulations later in this section of the flexibility to operate their SHOPs as are other measures of premium growth preamble. These changes will be they choose, in accordance with or income growth that we could use to effective as of the effective date of this applicable Federal and State law. calculate the required contribution rule. In the 2018 Payment Notice, HHS Notably, we received comments to the percentage. finalized the removal of a participation Request for Information that provided provision that had required certain QHP support for this proposed enrollment approach. Moreover, a few State rounded to the nearest one-hundredth of one issuers to participate in an FF–SHOP in percent. Exchanges currently utilize a similar 54 For any given year, the premium adjustment 55 81 FR 12346 (March 8, 2016). enrollment approach as is being percentage is the percentage (if any) by which the 56 https://www.cms.gov/CCIIO/Resources/ finalized as a transitional measure that most recent NHEA projection of per enrollee Regulations-and-Guidance/Downloads/The-Future- was expected to extend through plan employer-sponsored insurance premiums for the of-the-SHOP-CMS-Intends-to-Allow-Small- preceding year exceeds the most recent NHEA Businesses-in-SHOPs-Using-HealthCaregov-More- years beginning in 2018. These SBEs estimate of per enrollee employer-sponsored Flexibility-when-Enrolling-in-Healthcare- have already inquired about continuing insurance premiums for 2013. Coverage.pdf. to permit enrollment of their SHOP

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consumers through a participating QHP take when this rule becomes effective. file the appeal directly with the SHOP issuer, or a SHOP-registered agent In light of the substantial changes, we insurance company, or could take or broker, for plan years beginning in have made conforming amendments and advantage of other appeals mechanisms 2019 and beyond.57 Additionally, these updated applicable cross references in under applicable State and Federal law. SBEs have each indicated that this these and other regulations, including If an employer group member enrolled enrollment method has contributed to §§ 147.102, 147.104, 155.500, 156.200, in coverage though a SHOP operating reduced SHOP Exchange programmatic and 156.340. under the flexibilities outlined in this expenses, which is critical for SBEs to We are finalizing the following rule and believes that he or she were maintain financial sustainability as policies as proposed. SHOPs that opt to entitled to a SHOP special enrollment required by section 1311(d)(5)(A) of the operate in a leaner fashion, such as the period, but was denied that special PPACA. FF–SHOPs, will still assist qualified enrollment period, the employer group We are finalizing the modifications employers who are small employers in member could file a complaint with the throughout the requirements applicable facilitating the enrollment of their SHOP and the SHOP will investigate. in the SHOPs for plan years beginning employees in QHPs offered in the small SHOP special enrollment periods will on or after January 1, 2018, effective on group market in the State, consistent continue to be available to enrollees the effective date of this rule. However, with section 1311(b)(1)(B) of the who experience specified qualifying because some groups’ plan years that PPACA, because the basic events. SHOPs that use the new begin prior to the effective date of this functionalities of an Exchange will still flexibilities, such as the FF–SHOPs, will final rule will continue beyond the be provided. SHOPs will continue to be no longer have the information required effective date of this rule, both the required to certify plans for sale through to determine employer group members’ existing requirements applicable to a SHOP, and the following features will eligibility for special enrollment plans beginning before January 1, 2018, still be available: An internet website periods. Therefore, issuers wishing to and the new requirements applicable to that displays and provides QHP participate in such a SHOP will be plans beginning after January 1, 2018 information, a premium calculator that required to administer special will need to be in place simultaneously. generates estimated prices of the enrollment periods. For this reason, we are finalizing our available QHPs, and a call center to SHOPs opting to operate in a leaner proposal to make many of the existing answer questions related to the SHOP. fashion, like the FF–SHOPs, will regulatory sections regarding SHOP Further, small employers will continue continue to provide employers with the applicable for plan years beginning to obtain an eligibility determination option to offer a choice of plans, prior to January 1, 2018 only, and new from the SHOP website but will enroll consistent with section 1312(a)(2) of the regulatory sections applicable for plan in a SHOP QHP by working with a PPACA, by continuing to allow years beginning on or after January 1, SHOP-registered agent or broker, or with employers to offer their employees a 2018. After the effective date of this a QHP issuer participating in a SHOP to choice of plans, either by coverage level, rule, the new regulatory sections will be complete the enrollment process. or, in some States, by participating QHP effective for all 2018 plans, regardless of An enrollment completed by working issuer. Employers will be able to see the whether the plans started prior to the with a SHOP-registered agent or broker, SHOP plans available, by coverage level effective date of the rule. Except as or with a QHP issuer participating in a and issuers, in their area using the plan described in this rule, we proposed and SHOP in the SHOPs that decide to comparison tool available on a SHOP now finalize that these new regulatory operate in a leaner fashion, like the FF– website. Employers who choose to offer sections will mirror the existing SHOPs, will be considered to be an a choice of plans to employees would regulatory sections. enrollment through a SHOP, and an contact the participating QHP issuers Specifically, we proposed to amend employer will be considered to have whose plans they would like to offer to §§ 155.705, 155.715, 155.720, 155.725, offered its employees coverage through their employees to obtain the 155.730, 155.735, 155.740, 156.285 and a SHOP for purposes of section 45R of application information necessary in 157.205 to make each section applicable the Code (the Small Business Health order to enroll in coverage. only to plan years beginning prior to Care Tax Credit), if the employer: (1) Once the necessary information January 1, 2018. Additionally, we Obtains from the SHOP a favorable required to enroll is obtained from the proposed to introduce mirroring new determination of eligibility to QHP issuer or issuers or from the SHOP- sections, applicable for plan years participate in the SHOP; (2) enrolls in registered agent or broker, the employer beginning on or after January 1, 2018, at a SHOP QHP offered by an issuer; and could disseminate the application §§ 155.706, 155.716, 155.721, 155.726, (3) chooses to have the enrollment information to its employees. The 155.731, 155.741, 156.286 and 157.206. identified as being through the SHOP. If employer could later collect the We did not propose a new section an enrollment meets this definition, the information from its employees and mirroring current § 155.735, as further QHP issuer will be required to conduct send it to the applicable QHP issuer or explained later in this preamble. We enrollment with all applicable SHOP issuers or the SHOP-registered agent or also proposed minor changes to rules and policies. broker. Employers generally will also be § 155.700. These are described in the Because SHOPs will be required to responsible for collecting monthly sections that follow. We also proposed determine employer eligibility to premium payments from employees and additional changes related to the participate in a SHOP only, and will not sending them to the appropriate issuers. proposed new approach to SHOP in be required to determine employer While initially offered to support §§ 155.106, 155.200, and 156.350, to group members’ eligibility to enroll, employers’ option to offer a choice of define the streamlined enrollment SHOPs will only be required to handle plans across issuers, premium approach that groups enrolling in a appeals as they relate to an employer’s aggregation functions are not a function SHOP QHP in an SBE–FP for SHOP will eligibility in a SHOP, as currently mandated by the PPACA and therefore described in § 155.740. If, under the may be altered or removed, as 57 Extension of State-based SHOP Direct flexibilities described here, employer previously proposed and now finalized Enrollment Transition (April 18, 2016), available at group members enrolled in a SHOP with this rule. SHOP-registered agents https://www.cms.gov/CCIIO/Resources/Regulations- and-Guidance/Downloads/1332-and-SHOP- QHP needed to file an appeal related to and brokers will be able to assist Guidance-508-FINAL.pdf. their SHOP coverage, they generally will employers in performing these tasks, if

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the employer chooses to work with a The current regulations will also be in sections of the preamble. The primary SHOP-registered agent or broker. place for the beginning of plan year purpose of these regulatory changes was Additionally, to further support 2018 for those plans that start before the not to increase the attractiveness of employers’ option to offer a choice of effective date of this rule. But, after the SHOPs to small employers, but to plans across issuers, under the effective date of this rule, the finalized remove the regulatory burden on SHOPs proposals we are finalizing, an regulations pertaining to plan year 2018 to give Exchanges the flexibility to employer’s minimum participation rate will be effective for all plans that begin operate their SHOPs in a cost-effective will continue to be calculated at the or began in 2018, regardless of whether way that best meets the needs of their employer level, though the SHOPs will the enrollment occurred prior to the State’s small group market. We believe not be required to calculate it, and the effective date. HHS acknowledged that this rule achieves that primary purpose. FF–SHOPs will no longer calculate it. this transition would create challenges Nonetheless, under this rule, SHOPs No changes were proposed to the way and was concerned about employers will continue to offer a centralized in which an employer’s minimum enrolling between when rates become system that will provide certain free and participation rate is calculated or to the available for plan years beginning in impartial information to small 70 percent minimum participation rate 2018 and when the flexibilities in this employers looking for coverage. For default in FF–SHOPs. Participating QHP rule will go into effect. We sought example, all SHOPs, including FF– issuers will not be permitted to deny comment on how to best ease this SHOPs, will still be required to make a enrollment on the basis of failure to transition and did not receive any premium calculator available. This meet minimum participation comments on this point. In addition, we calculator will provide small employers requirements to employers who have released guidance on this issue in seeking SHOP coverage with free and been determined eligible to participate conjunction with the release of the impartial information about the SHOP in the SHOP, and who have met the proposed rule.58 QHP and stand-alone dental plan QHP applicable minimum participation rate, Because many comments focused on options available in their area. With as specified by the SHOP, even if only the general approach we had proposed regard to any burden on agents, brokers, one employee in a group wishes to for SHOPs, we have summarized and issuers, we believe that the enroll with a particular issuer. comments related to SHOP proposals proposed changes will reduce, rather Under the approach we proposed and here, with a few exceptions, rather than than increase, the burden for agents, are finalizing, SHOPs will also still be after summarizing the proposed brokers and issuers. For example, in able to administer the provision at amendments to each section. SHOPs that use the finalized section 1304(b)(4)(D) of the PPACA that Comment: Many commenters flexibilities, issuers will no longer be guarantees continuing eligibility for supported our proposal to remove many required to maintain the infrastructure growing small employers by limiting the of the regulatory requirements imposed to connect with SHOPs, and agents and validity of an employer’s eligibility upon SHOPs. Some commenters brokers who assist small groups in determination such that it terminates expressed concern over our proposal to enrolling in SHOP coverage will use the when the employer makes a change that remove the regulatory burden on issuer enrollment channels they are could end its eligibility under SHOPs, stating that removing such most familiar with, not a SHOP website. § 155.710(b), by requiring the employer requirements does not address the As previously noted, given the to submit a new single employer reasons the SHOP Exchanges have been reduction in issuer participation in the application to the SHOP if the employer unattractive to small employers. We SHOPs, HHS believes the impact of makes a change that could end its received a comment specifically noting removing the requirement to maintain eligibility under § 155.710, and by that SHOPs saw low enrollment for premium aggregation functions, which requiring issuers to be able to reasons other than a poor enrollment the FF–SHOPs and SBE–FPs for SHOP distinguish SHOP enrollments from system. Some commenters requested will no longer have, will be minimal. non-SHOP enrollments. Under the that HHS should require that State HHS also notes that State Exchanges are flexibilities being finalized, issuers will Exchanges either operate entirely under encouraged to continue to operate their be expected to rely on the determination the SHOP regulations prior to them SHOPs as they do today, or design a of eligibility to reflect the employer’s being amended or otherwise identically SHOP within the bounds of the ongoing eligibility to participate in the to how the FF–SHOP will operate. We flexibilities being finalized within this SHOP, and the IRS will have the option also received a comment stating that final rule. to follow up with an employer for removing many of the requirements on Comment: We received comments additional information if necessary. SHOPs will also do away with a seeking clarification on the applicability HHS understands that the changes centralized system for free and impartial of other Exchange requirements to outlined in this final rule will allow information for small employers looking SHOPs where we did not explicitly SHOPs to adopt changes (and that the for coverage. One commenter noted that propose changes. Specifically, we FF–SHOPs will adopt such changes) the proposals would impose an received comments requesting that result in a substantial departure additional burden on agents, brokers, clarification on whether HHS will from current operations for participating and issuers without providing collect SHOP enrollment data under SHOP QHP issuers, employers, and additional compensation. § 155.1200(b)(2) from either States or enrollees. It is important to note that Response: We are finalizing the issuers, in States where the Exchange employer groups enrolled in a SHOP policies as proposed, with minor, pursues the flexibilities outlined herein, plan that began in 2017 in a SHOP that mostly non-substantive adjustments such as the FF–SHOP States. We also will opt to operate in a leaner fashion, further described in the following received a comment seeking like the FF–SHOPs, will not be affected clarification on whether States that until their plan year ends, as the current 58 CMS to Allow Small Businesses and Issuers operate under the flexibilities described regulations will be in effect for the New Flexibilities in the Small Business Health herein would be required to perform entirety of a plan that began in 2017. We Options Program (SHOP) For Plan Year 2018 enrollee satisfaction surveys, as (October 27, 2017), available at https:// recognize that some employers have www.cms.gov/CCIIO/Resources/Regulations-and- described under § 155.200(d). already completed an enrollment that Guidance/Downloads/New-Flexibilities-SHOP- Response: HHS recognizes that took effect on or after January 1, 2018. 2018.pdf. Exchanges that operate under these

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SHOP flexibilities may not have records paragraph (f), to state that the section § 155.705(b)(4) that would be applicable of SHOP enrollments, and as such, does would apply only for plan years that in plan years beginning on or after not expect these Exchanges to submit begin prior to January 1, 2018. We January 1, 2018, would be an amended SHOP enrollment data to HHS under discuss new § 155.706 below. version of the function in § 155.1200(b)(2). QHP issuers are We are finalizing this policy as § 155.705(b)(4)(ii)(A), relating to the required to contract with an HHS- proposed. Comments related to the continuation of coverage. State approved enrollee satisfaction survey proposed approach for SHOP are Exchanges would be permitted to vendor to administer the enrollee discussed at the beginning of section continue providing remaining premium satisfaction survey of QHPs’ enrollees, III.D.9 of this rule. aggregation functions in their SHOPs and Exchanges, including SHOPs, are c. Functions of a SHOP for Plan Years currently described at § 155.705(b)(4) if merely required to continue overseeing Beginning on or After January 1, 2018 they choose to do so. SHOPs electing implementation of the enrollee (§ 155.706) not to provide premium aggregation satisfaction surveys, as described at functions, like the FF–SHOPs, would § 155.200(d). Section 155.705 describes required still be required to provide an Exchange functions that are specific to opportunity for employers to offer a. Standards for the Establishment of a SHOPs. To permit SHOPs to operate in employees a choice of plans. In SHOPs SHOP (§ 155.700) a leaner fashion for plan years beginning not offering premium aggregation Section 155.700 outlines the general on or after January 1, 2018, we proposed functions, we stated that we expected requirements to establish a SHOP and several changes to the required that employers generally would receive defines certain terms specific to SHOPs. functions of a SHOP to become effective premium bills from each of the plans or We proposed to amend § 155.700(a) by as of the effective date of this rule. issuers with which an employee enrolls adding paragraph (a)(1) to make the Under these proposals, which we and will pay premiums to each such current requirements applicable for only proposed to introduce in new § 155.706, plan or issuer. Section plan years beginning prior to January 1, certain functions that are currently 155.705(b)(4)(ii)(A) (which we proposed 2018. We proposed to add paragraph required would become optional for to include in a revised form in (a)(2) to describe the general SHOPs for plan years beginning on or § 155.706) describes the process through requirements applicable for plan years after January 1, 2018, and the FF– which the SHOP may enter into an beginning on or after January 1, 2018. SHOPs would not provide them. With agreement with a qualified employer Proposed paragraph (a)(2) more closely the exception of the proposed changes related to the administration of aligns with the statutory language in to the functions described here, the continuation coverage. Under the section 1311(b)(1)(B) of the PPACA than functions would remain the same as in approach for enrollment in a SHOP QHP existing paragraph (a), and will specify § 155.705. We proposed only to include for plan years beginning on or after that SHOPs must assist qualified the paragraphs in current paragraph January 1, 2018, the FF–SHOPs would employers in facilitating the enrollment (b)(3) of § 155.705, that would be no longer facilitate the collection of of their employees in small group applicable to plan years beginning on or premiums. Therefore, we proposed that market QHPs. We believe that the after January 1, 2018, maintaining the § 155.706(b)(4) would mirror PPACA does not have to be interpreted currently applicable policy requiring § 155.705(b)(4)(ii)(A), but would not to require SHOPs to process the SHOPs to allow employers to select a include the provision that permits the enrollment of qualified employees into level of coverage and to offer a choice FF–SHOPs to limit the service to the QHPs, as is required by the current of QHPs across that level of coverage, collection of premiums related to the regulation. Instead, we believe it can and permitting SHOPs to allow requirements under 29 U.S.C. 1161, et also be interpreted in a less burdensome employers to offer a choice of all QHPs seq. way, to require SHOPs to assist from a single issuer, or another method Paragraph (b)(7) of § 155.705 describes qualified employers in facilitating of providing employer choice. To the SHOP function related to QHP employees’ enrollment into QHPs, provide additional flexibility, we also availability in merged markets and which will still be provided for under proposed to codify that State Exchanges paragraph (b)(8) describes the function our proposals. We sought comment on may, as the FF–SHOPs have, offer related to QHP availability in unmerged this proposal. employers a choice of SADPs in their markets. We proposed to include these We are finalizing as proposed; these SHOPs. To reflect the proposals functions in § 155.706(b)(7) and (b)(8). changes will be effective as of the described in § 156.150(b) of this However, under the proposal to effective date of this rule. Comments document, we proposed that State streamline SHOP enrollment for plan related to the proposed approach for Exchanges could, and FF–SHOPs years beginning on or after January 1, SHOP are discussed at the beginning of would, allow employers to offer a 2018, we proposed to change the section III.D.9 of this rule. choice of SADPs in their SHOP. If no references to a ‘‘qualified employee’’ to SADP coverage levels are available, an ‘‘employer group’’ in both b. Functions of a SHOP (§ 155.705) for employers would be able to offer a paragraphs, as the SHOP would no Plan Years Beginning Prior to January 1, choice of all SADPs offered in an area. longer be required to process employee 2018 (§ 155.705) We also proposed conforming enrollments. As discussed in the following section, amendments to the structure of this Paragraph (b)(10) of § 155.705 we proposed to modify the regulatory paragraph. establishes requirements related to requirements regarding functions of a Because, as discussed earlier in this minimum participation rates and SHOP SHOP for plan years beginning on or preamble, premium aggregation coverage; we proposed to include these after January 1, 2018, and to introduce functions are not mandated by the requirements in § 155.706(b)(10), with those requirements in a new § 155.706. PPACA and to maximize the flexibilities certain modifications. In order to To reflect the proposal that the associated with operating a SHOP, we facilitate employers’ ability to offer requirements currently in § 155.705 will proposed to remove required functions employees a choice of plans through a apply only for plan years beginning related to premium aggregation. SHOP, as is required under section before January 1, 2018, we proposed to Specifically, we proposed that the only 1312(a)(2) of the PPACA, amend the heading of § 155.705 and add premium aggregation function from § 155.705(b)(10) requires that any

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minimum participation rate applicable Specifically, § 155.706 (b)(11) would rate in FF–SHOPs, and another in a SHOP be calculated based on the specify that the premium calculator requested that the 70 percent minimum rate of employee participation in the described in § 155.205(b)(6) must participation rate be lowered. We also SHOP, rather than on the rate of facilitate the comparison of available received a comment disagreeing with participation in any particular QHP or QHPs. This would reflect that SHOPs the intent of the proposals within this QHPs of any particular issuer. In the would no longer be required to maintain section. A commenter noted that groups FF–SHOPs, this requirement has been enrollment and premium payment that do not meet the minimum implemented through the requirements information or administer premium participation rate should not be currently outlined at § 155.705(b)(10)(i)– billing, and therefore, would no longer permitted to enroll in coverage. Finally, (iii). Currently, the FF–SHOPs calculate necessarily have employer contribution a commenter requested that HHS a group’s minimum participation rate information. SHOPs would be required continue to promote the annual 1-month based on the information provided by to maintain a calculator that facilitates window in which the minimum the employer and the employees during the comparison of available QHPs and participation rate does not apply. online enrollment. Under the approach would generate premium estimates, but Response: In our proposed changes to we proposed, SHOPs would not be would no longer be required to reflect SHOPs, we did not propose to change required to collect the enrollment any employer contribution. Therefore, the applicable minimum participation information needed to calculate a we proposed to not include the rate, or the way in which the minimum group’s minimum participation rate. requirements in § 155.705(b)(11)(i) or participation rate is calculated. The FF– Issuers would be permitted to use their (ii) in § 155.706(b)(11), since these SHOPs will continue to maintain a established practices allowed under reflect methods SHOPs would use for minimum participation rate of 70 State law for groups enrolling in their determining employer contributions. In percent unless otherwise specified by certified SHOP plans for plan years the FF–SHOPs, this premium calculator the State. This percentage is consistent beginning on or after January 1, 2018, so would be where an employer or SHOP- with industry standards. The annual long as they comply with § 147.104, and registered agent or broker could go to 1-month window from November 15– so long as the minimum participation see a complete listing of all the QHPs December 15, when employers can rate is calculated based on the level of available in a given area. The tool has enroll in a SHOP QHP without meeting participation in the SHOP instead of on served and would continue to serve as any minimum participation rate for the level of participation in any one a resource for employers and SHOP- their State, will remain in place. This QHP or with any one issuer (that is, so registered agents and brokers. Because window aligns with the guaranteed long as SHOP participation is measured we believe the premium calculator availability standards outlined in the at the employer group level). We did not requirement at section 1311(d)(4)(G) of PPACA. Comment: We received a comment in propose to make any changes to the way the PPACA could be interpreted to support of our proposal to codify an in which the minimum participation apply to only individual market employer’s ability to offer a choice of rate in SHOPs is calculated or the Exchanges based on its reference to SADPs and our proposal to allow default 70 percent minimum APTCs and CSRs, which are not employers to offer a choice of all SADPs participation rate used in the FF–SHOPs available through SHOPs, we believe offered through a SHOP, in accordance unless otherwise determined by a State. that this proposal is consistent with the with the proposals made elsewhere in Issuers participating in the FF–SHOPs statute. Section 155.705(c) generally requires this rule to remove actuarial values for would be required to adhere to the level a SHOP to provide data related to SADPs. of participation as would continue to be eligibility and enrollment of a qualified Response: We are finalizing this specified in § 155.706(b)(10), and employee to the applicable individual policy as proposed, with revisions to the issuers offering QHPs in State market Exchange. For plan years regulation text to reflect the changes to Exchanges would be subject to any beginning on or after January 1, 2018, the actuarial value requirements for minimum participation rate established we proposed that this requirement SADP QHPs, as noted in the proposed by the SHOP, consistent with this would apply only in SHOPs that collect rule, and to clarify that the third option provision. We also proposed that employee enrollment data related to refers to all SADPs offered in an area by § 155.706(b)(10) would not include the eligibility and enrollment of a qualified a single issuer. We also added a title for language in § 155.705(b)(10)(i) because employee, unless the SHOP is operated paragraph (b)(4) that was inadvertently it applies to plan years beginning before pursuant to § 155.100(a)(2). omitted in the proposed rule. January 1, 2016, and would therefore Finally, we proposed in paragraph (e) Comment: We received a comment not be applicable for the period covered that the provisions of the section would requesting that the option for States to in § 155.706. We also proposed to clarify be applicable for plan years beginning submit an annual letter opting out of the that, under the proposed approach, the on or after January 1, 2018. third method of employee choice, a reference in proposed § 155.706(b)(10) We are finalizing these policies as choice of all plans offered by a single to the time the employer submits the proposed, except that we are finalizing issuer, be removed. SHOP group enrollment would be minor changes to reflect the changes to Response: We did not propose to interpreted to mean the time when the the actuarial value requirements for remove this option in the proposed rule, employer submits a complete group SADP QHPs in § 156.150 of this rule, and are finalizing this section as enrollment or renewal to the QHP issuer and small, nonsubstantive changes to described earlier in the preamble for or SHOP-registered agent or broker, if the regulatory text for clarity and this section. We continue to believe it is applicable. consistency; these policies will be important for States to have a choice Section 155.705(b)(11) specifies the effective as of the effective date of this regarding whether employee choice of requirements related to an online rule. all QHPs offered by a single issuer premium calculator. For plan years Comment: We received a few applies in their markets. beginning on or after January 1, 2018, comments regarding the minimum Comment: One commenter noted that we proposed to modify these participation rate in SHOPs. One without premium aggregation, it is requirements and include the modified commenter requested that we maintain difficult or impossible for small requirements in § 155.706(b)(11). the 70 percent minimum participation businesses to offer a choice of multiple

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insurers and plans to their employees. eligibility determination process for sufficient proof that they meet The commenter recommended that HHS SHOPs for plan years beginning on or applicable criteria. Part of the provide data on the number of after January 1, 2018. With the employer’s responsibility in providing employers currently offering employee exception of the changes to the process evidence that it is a small employer choice in the FF–SHOPs and provide described here, the process will remain eligible for the Small Business Health annual updates on that data, so that the same as in § 155.715. However, this Care Tax Credit includes the ability to HHS, stakeholders, and policymakers new section will modify and remove verify not only the purchase of a SHOP can monitor the impact of this change some of the requirements in § 155.715. QHP, but the ability to produce a on employee choice in SHOP. The proposals described in this section favorable eligibility determination from Response: As discussed throughout will be effective on the effective date of a SHOP. Therefore, employers applying this preamble, HHS believes that the this rule. for the Small Business Health Care Tax PPACA does not have to be interpreted Section 155.715(a) requires that before Credit are also encouraged to obtain an to require SHOPs to provide premium permitting the purchase of coverage in eligibility determination from the SHOP aggregation functions and thus is a QHP, a SHOP must determine that the in the taxable year in which they intend finalizing the proposals to allow SHOPs employer or individual who requests to apply for the credit. to not provide premium aggregation coverage is eligible. This requirement Section 155.715(b) requires the SHOP functions other than those related to means that employers and employees to accept SHOP applications from both continuation of coverage under finalized must complete an application to employers and employees, and § 155.706(b)(4). State SHOPs are participate in a SHOP. Accordingly, the § 155.715(c) provides for the verification permitted to continue offering premium FF–SHOPs have established certain of both employer and employee aggregation functionality. While we operational requirements related to eligibility. For plan years beginning on recognize that the elimination of submitting an application through the or after January 1, 2018, we proposed to premium aggregation in the FF–SHOPs FF–SHOP website, including providing provide SHOPs flexibility to forgo could increase the administrative information on the business (including providing for employee eligibility burden on employers, we believe that location, Employer Identification determinations and related functionality potential increased burden is Number, and number of employees), and obligations (and the FF–SHOPs will outweighed by the other benefits to the and identity verification. pursue this flexibility). We proposed SHOPs and, ultimately, to the To reduce the barriers on employers that SHOPs would not be required to employers described throughout this to obtain SHOP coverage, we proposed accept applications by employees or preamble regarding the changes to the in § 155.716 that SHOPs must determine determine eligibility of employees SHOPs. Under the proposals being that the employer who requests because, under the proposed approach finalized in this rule, SHOPs will not be coverage is eligible, but that SHOPs to enrollment in a SHOP, SHOPs will required to have access to ongoing generally would not always need to do not be required to interact with enrollment information, and the FF– so before the issuer permits the employees. Proposed paragraphs (b) and SHOPs will not require issuers to report purchase of coverage in a QHP through (c) of § 155.716 would still require SHOP employee choice enrollment a SHOP, for plan years beginning on or SHOPs to accept a SHOP single information to HHS. after January 1, 2018. This would employer application form from generally permit an employer to employers, and to verify employer d. Eligibility Determination Process for purchase a QHP before obtaining a eligibility subject to provisions like SHOP for Plan Years Beginning Prior to determination of SHOP eligibility and those currently in § 155.715(c)(2) January 1, 2018 (§ 155.715) confirming with the issuer the status of through (4). We have updated and made As discussed in the following section, the enrollment as being through the available a single employer application we proposed to modify the regulatory SHOP. As further explained in the that SHOPs can use to determine requirements regarding the eligibility preamble to § 156.286, issuers would be employer eligibility to participate in the determination process for SHOP for expected to establish processes to SHOP to reflect the new rule at plan years beginning on or after January ensure that they can accurately identify § 155.731, described elsewhere in this 1, 2018, effective on the effective date of which enrollments are considered preamble. Currently, employee this rule, and to introduce those SHOP enrollments and which are not. information is primarily collected for requirements in a new § 155.716. To We encouraged employers to obtain an purposes of enrollment, and therefore reflect that the requirements currently eligibility determination from a SHOP will not be necessary for SHOPs to in § 155.715 will apply only for plan as close to the date in which they collect under the approach we are years beginning before January 1, 2018, purchase a SHOP QHP as possible. We finalizing, allowing SHOPs to operate in we proposed to amend the heading of considered establishing a limit on how a leaner fashion. State Exchanges that § 155.715 and add paragraph (h), to state long an employer can wait between intend to maintain more robust SHOP that the section applies only for plan purchasing the QHP and obtaining the functionalities, in lieu of the flexibilities years that begin prior to January 1, 2018. determination of eligibility for that QHP adopted in this rule, will be permitted We are finalizing this section as to be considered purchased through the to continue to determine employee proposed. Comments related to the SHOP. We solicited comments on eligibility. We believe this proposal is proposed approach for SHOP are whether to establish such a limit, and consistent with the statute because, as discussed at the beginning of section how long it should be. Ultimately, we noted above, the PPACA does not have III.D.9 of this rule. are finalizing this policy as proposed, to be interpreted to require SHOPs to and are not establishing a timeline provide for employee enrollment e. Eligibility Determination Process for under which employers must obtain an functionality, and does not define SHOP for Plan Years Beginning on or eligibility determination from a SHOP qualified employees. After January 1, 2018 (§ 155.716) for their enrollments to be considered Paragraph (d) of § 155.715 describes Section 155.715 describes the SHOP through the SHOP. the eligibility adjustment period. We eligibility determination process for As a condition of claiming the Small proposed to include in § 155.716(d) employers and employees. We proposed Business Health Care Tax Credit, small these requirements as they relate to to add new § 155.716 to describe the employers must be prepared to provide eligibility for employers. However,

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because SHOPs will not be required to This could include terminating offers of employer’s withdrawal. The commenter accept applications from employees, we coverage to employees maintaining full- recommended that we not require proposed not to include the time status, growing to be a large employers to notify the SHOP of their requirements in § 155.715(d)(2), relating employer without having maintained intent to withdraw their participation to eligibility for employees, in new continuous SHOP coverage, or moving from a SHOP and, therefore not require § 155.716. We also proposed to add its principal business address or eligible SHOPs to acknowledge an employer’s language to reflect that SHOPs also must employee worksites out of the SHOP withdrawal. address inconsistencies in employer service area. The employer will be Response: Although we appreciate the eligibility information received from required under new regulations being commenter’s suggestion as another way sources other than those used in the finalized in part 157 to take further to ease burden on employers, for SHOPs employer eligibility process described action upon termination of the validity to be able to determine which in § 155.715(c). of the determination of eligibility to employers remain eligible to participate, To reflect our proposed changes to the participate in a SHOP to submit a new the rules must impose some obligation employer eligibility verification process, application for determination of on employers to notify the SHOP when as further described in this section and eligibility or to withdraw from their eligibility ends. As such, as further in the preamble to § 157.205, and our participation in the SHOP. We described in the preamble to § 157.206, proposal not to include a section considered requiring SHOPs to we are finalizing our proposal that mirroring § 155.735 regarding acknowledge an employer’s withdrawal requires employers to submit a new terminations, we are adding a from participation in the SHOP within single employer application to the requirement in the paragraphs mirroring a reasonable time. Alternatively, we SHOP or withdraw from participating in paragraphs (d)(3)(i) and (e) of § 155.715 considered requiring that employers the SHOP if the employer makes a to require the SHOP to notify employers reapply to determine their SHOP change that could end its eligibility not only of a denial of the employer’s eligibility on an annual basis. We sought under § 155.710 of this subchapter. As eligibility to participate in the SHOP, comment on these proposals, and noted above, SHOPs will not be but also of a termination of the ultimately are moving to finalize our required to acknowledge an employer’s employer’s eligibility to participate in proposal without requiring employers to withdrawal. the SHOP. reapply to determine their SHOP f. Enrollment of Employees Into QHPs Paragraph (f) of § 155.715 specifies the eligibility on an annual basis or requirement that the SHOP notify an Under SHOP for Plan Years Beginning requiring SHOPs to acknowledge such a Prior to January 1, 2018 (§ 155.720) employee of his or her eligibility to withdrawal. enroll in a SHOP. Because we will not We proposed to specify in paragraph Section 155.720 contains be requiring SHOPs to determine (g) that the provisions in § 155.716 will requirements related to the enrollment employee eligibility for plan years be applicable for plan years beginning of employees into QHPs under SHOP. beginning on or after January 1, 2018, on or after January 1, 2018. To reflect that our proposed approach we proposed not to include this We are finalizing these policies as would no longer require SHOPs to requirement in § 155.716. SHOPs that proposed. These changes will become provide functionality related to continue to provide employee eligibility effective as of the effective date of this enrollment of employees for plan years functionality should continue notifying rule. beginning on or after January 1, 2018, employees of their eligibility. In the Comment: We received several we proposed to amend the heading of SHOPs that operate in a leaner fashion, comments urging us not to establish a § 155.720 and add paragraph (j), to state like the FF–SHOPs, we anticipate that 30-day timeline on employers to obtain that the section will apply only for plan the participating QHP issuer or an eligibility determination because the years that begin prior to January 1, 2018. employer will determine the method of timeframe would be burdensome on Specifically, we proposed that the employee enrollment and notification, employers. We received comments from requirement in paragraph (b) of consistent with otherwise applicable State Exchanges also recommending § 155.720 that SHOPs establish a Federal or State law. that no timeline should be established timeline and process for QHP issuers Paragraph (g) of § 155.715 describes for SHOP. These State Exchanges do not and employers to follow regarding the requirements surrounding impose such a timeline in their SHOPs purchasing coverage and processing of communication between the SHOP and and have found success with the model. enrollment would not be applicable for QHP issuers in the event of an employer Response: We are finalizing this plan years that begin on or after January withdrawing from the SHOP and the section as proposed, and no timeline 1, 2018. State Exchanges that choose to notification of qualified employees of an will be imposed on employers to obtain maintain their current operations may employer’s withdrawal from SHOP. an eligibility determination from a continue establishing enrollment Under the proposed approach for SHOP. We note that issuers may require timelines, as State law and SHOP SHOPs beginning for plan years that employers to obtain an eligibility technology permit. We also proposed begin on or after January 1, 2018, the determination from the SHOP as a that the requirements to transmit enrollment and disenrollment processes condition of enrollment when there is a enrollment information on behalf of would be addressed between the legal basis for restricting enrollment to qualified employers and employees to employer and the issuer or the agent or enrollment through the SHOP. Further, QHP issuers as described in current broker. Therefore, we proposed not the IRS may request to see an paragraph (c), and to process payments including these requirements in employer’s eligibility determination as described in current paragraph (d) § 155.716. from the SHOP if the employer chooses would not apply after plan year 2017, We further proposed in paragraph (f) to apply for the Small Business Health since SHOPs may not have enrollment of § 155.716 that an employer’s Care Tax Credit. or payment information to transmit. We determination of eligibility to Comment: We received one comment proposed that the requirement in participate in the SHOP obtained under regarding whether employers should be paragraph (e) that SHOPs ensure a QHP paragraph (a) remains valid until the required to notify a SHOP of their intent issuer notifies a qualified employee employer makes a change that could to withdraw from a SHOP, and if a enrolled in a QHP of the effective date end its eligibility under § 155.710(b). SHOP should acknowledge an of his or her coverage would not apply

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for plan years beginning on or after after January 1, 2018, effective on the h. Enrollment Periods Under SHOP for January 1, 2018 because SHOPs may not effective date of this final rule, SHOPs Plan Years Beginning Prior to January 1, have the enrollment information would be required to send the IRS 2018 (§ 155.725) necessary to enforce this requirement. information about the employers As discussed in the following section, We anticipated QHP issuers will notify determined eligible to purchase a SHOP we proposed to modify the regulatory employees in accordance with QHP only upon the request of the IRS. requirements regarding enrollment applicable State law. Additionally, after We stated that we believe providing the periods under a SHOP for plan years plan year 2017 plans have ended, we IRS with a list of employers determined beginning on or after January 1, 2018, proposed not to require SHOPs to eligible to participate in a SHOP, at the and to introduce those requirements in reconcile enrollment information as IRS’s request, fulfills HHS’s reporting a new § 155.726. To reflect the proposal described in paragraph (g), as SHOPs responsibility. As mentioned earlier in that the requirements currently in may not have enrollment files to this document, employers in all States § 155.725 would apply only for plan reconcile with issuers. We also must be able to provide sufficient years beginning before January 1, 2018, proposed that the requirements evidence to the IRS that they meet all we proposed to amend the heading of described in current paragraph (h), the necessary eligibility requirements § 155.725 and add paragraph (l), to state which requires a SHOP to notify a for the Small Business Health Care Tax that the section would only apply for qualified employee’s employer in the Credit, if they intend to apply for it. The plan years that begin prior to January 1, event the qualified employee terminates IRS may ask employers to produce the 2018. These changes would become his or her SHOP coverage, would no aforementioned evidence and employers effective as of the effective date of the longer apply for plan years beginning on final rule. We discuss the proposed new or after January 1, 2018. Under the have a responsibility to produce it. proposed approach, SHOPs may not Further, we stated that employers may § 155.726 below. We are finalizing these policies as have that information to communicate work with their issuer to verify their proposed. Comments related to the to the qualified employee’s employer. contribution information, employee We are finalizing these policies as enrollment information, and any other proposed approach for SHOP are proposed. These changes will become applicable information required to discussed at the beginning of section effective as of the effective date of the apply for the Small Business Health III.D.9 of this rule. final rule. Comments related to the Care Tax Credit through their tax filings. i. Enrollment Periods Under SHOP for proposed approach for SHOP are We are finalizing these policies as Plan Years Beginning on or After discussed at the beginning of section proposed. January 1, 2018 (§ 155.726) III.D.9 of this rule. Comment: Commenters were Section 155.725 describes enrollment g. Record Retention and IRS Reporting generally supportive of these proposals. periods under SHOP, including the for Plan Years Beginning on or After One commenter disagreed with the timeline under which employer groups January 1, 2018 (§ 155.721) premise of this section, citing their lack must enroll in SHOP coverage, and the The approach we are finalizing will of support for the overall proposed notices the SHOP is required to send not require SHOPs to provide approach to allow SHOPs to operate in related to enrollment periods. We functionality related to enrollment of a leaner fashion. We also received a proposed to introduce a new § 155.726, employees for plan years beginning on comment supporting the proposals to which would retain the rolling or after January 1, 2018, and therefore, require SHOPs to only report enrollment and minimum participation we proposed that § 155.720 be information to the IRS as requested. rate provisions of § 155.725(b) and (k), inapplicable for those plan years, This commenter sought clarification on but would remove the requirements effective on the effective date of this whether HHS will continue to collect applicable to enrollment periods under rule. However, there are requirements in SHOP enrollment data per § 155.1200, SHOP other than those related to special that section related to record retention which was addressed earlier in this rule enrollment periods for plan years and IRS reporting that will continue to at the beginning of section III.D.9. beginning on or after January 1, 2018, to be applicable with some modifications. Finally, one commenter expressed reflect the increased flexibility we We proposed to include modified concern about an employer’s access to proposed. The policies described in this versions of these requirements in a new claim the Small Business Health Care section were proposed to be effective on § 155.721, titled ‘‘Record retention and Tax Credit if an employer is in a county the effective date of this rule. IRS Reporting for plan years beginning where no SHOP plans are available. The Section § 155.725(a) requires that on or after January 1, 2018.’’ commenter noted that in the past, the SHOPs ensure that enrollment We proposed that all SHOPs still be IRS has granted flexibility to employers transactions are sent to QHP issuers and required to maintain records of in counties that had no SHOP plans that issuers adhere to coverage effective employer eligibility for 10 years, as available and allowed employers to still dates in accordance with this section. We proposed that many previously described in paragraph (f). Because claim the Small Business Health Care required enrollment and election SHOPs utilizing the proposed Tax Credit, if otherwise applicable. flexibilities, like the FF–SHOPs, would periods would no longer apply for plan not have information on employees, we Response: We are finalizing this years beginning on or after January 1, did not propose to continue requiring section as proposed. As noted above, we 2018. State Exchanges that continue to that SHOPs maintain information on believe that the information being provide online enrollment functionality employees. collected under our proposals and for their SHOP will be able to continue Section 155.720(i) describes the communicating that information only as to adhere to these requirements. information a SHOP is currently requested by the IRS is sufficient for the However, under the proposed approach, required to communicate to the IRS for purposes of their administration of the some SHOPs (including the FF–SHOPs) purposes of the Small Business Health Small Business Health Care Tax Credit. may not have enrollment information to Care Tax Credit. We proposed to modify The Treasury Department and the IRS communicate to the issuers and may not the reporting requirement for SHOPs have jurisdiction over the Small want to continue setting and enforcing such that for plan years beginning on or Business Health Care Tax Credit. coverage effective dates under the

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previously specified requirements. In SHOPs that utilize these proposed responsibilities with respect to special SHOPs that pursue the full extent of the flexibilities, like the FF–SHOPs, may be enrollment periods. As stated earlier in proposed approach, like the FF–SHOPs, unable to satisfy the requirements in this preamble, under the new we anticipated that most enrollment § 155.725(g). To align with these flexibilities for SHOPs beginning in plan timelines, deadlines, and coverage proposed amendments, we proposed years starting on or after January 1, effective dates in SHOPs would be set that the requirements in § 155.725(g) 2018, SHOPs would no longer be by employers and issuers consistent would not apply for plan years required to provide functionality related with applicable State law and otherwise beginning on or after January 1, 2018. to enrollment of employees. For SHOPs applicable Federal law. We stated that Instead, we anticipated that enrollment that pursue this flexibility, like the FF– we did, however, believe that, under the timelines, deadlines, and coverage SHOPs, issuers will preliminarily be proposed approach, the SHOP should be effective dates for newly qualified responsible for completing enrollments, responsible for ensuring that QHP employees in SHOPs that pursue the and so we expected issuers would issuers adhere to the remaining required proposed approach would be set by implement enrollment periods. enrollment periods and their employers and issuers consistent with Therefore, we proposed to modify the corresponding coverage effective dates. applicable State law and otherwise requirements to reflect that the SHOP’s Therefore, we proposed to include this applicable Federal law, including revised role would not be to provide requirement in § 155.726(a). § 147.116. Further, as noted above, special enrollment periods, but to Paragraph (c) of § 155.725 states that issuers offering plans in SHOPs would ensure that QHP issuers offering the SHOP must provide qualified still be required to adhere to the coverage through the SHOP provide the employers with an annual election guaranteed availability requirements set special enrollment periods set forth in period prior to completion of the in § 147.104(b)(1)(i) and the special regulation. employer’s plan year and paragraph (d) enrollment period requirements in We are finalizing these policies as of § 155.725 requires the SHOP to proposed § 155.726(c). proposed, with one minor non- provide notice of that period in We also proposed that the substantive change to correct the advance. Given that, under the proposed requirement in § 155.725(h)(1) that a placement of numbering in the approach for SHOPs for plan years SHOP establish the effective dates of regulation text. beginning on or after January 1, 2018, coverage for initial and annual group Comment: Some commenters SHOPs would not be required to process enrollments would not apply for plan requested clarification on our proposals enrollments, we proposed that these years beginning on or after January 1, at § 155.726(c), and recommended that requirements would not apply for plan 2018. Because SHOPs utilizing the the proposals better align with years beginning on or after January 1, proposed flexibilities, like the FF– § 155.420, while another recommended 2018. We anticipated that participating SHOPs, would no longer be involved in that issuers be permitted to provide the QHP issuers in SHOPs pursuing the processing group enrollments, and same special enrollment periods as they proposed approach, like in the FF– would therefore not be able to hold provide outside the SHOP. SHOPs, would be responsible for setting issuers accountable to these enrollment Response: Special enrollment periods any requirements around renewals, deadlines, we stated that we believed it offered through a SHOP are aligned with annual employer election periods, and was more appropriate to permit QHP the special enrollment periods available annual employee open enrollment issuers in SHOPs to set their own in the individual market FFEs unless periods, based on their current enrollment timelines. However, State the special enrollment periods offered practices, and subject to applicable State Exchanges would be permitted to in the FFEs do not practically apply in law and otherwise applicable Federal continue establishing these effective the SHOP. We did not propose any law, including §§ 147.104 and 147.106. dates for their SHOPs. We also proposed changes to special enrollment periods in For similar reasons, we proposed that to remove paragraph (h)(2) for plan SHOPs and finalize this section as the requirements in § 155.725(e), which years beginning on or after January 1, proposed. requires the SHOP to set a standard 2018, which establishes the effective j. Application Standards for SHOP for open enrollment period for qualified dates for initial and annual group Plan Years Beginning Prior to January 1, employees, and § 155.725(f), which enrollments in FF–SHOPs, because the 2018 (§ 155.730) requires the SHOP to send a notice to FF–SHOPs would utilize the proposed the employee about the open enrollment flexibilities. We anticipated that issuers As discussed in the following section, period, would not apply for plan years in SHOPs that pursue this approach, we proposed to modify the regulatory beginning on or after January 1, 2018. like in FF–SHOPs, would set enrollment requirements regarding application Section 155.725(g) requires SHOPs to timelines for employer groups standards of a SHOP for plan years establish and maintain enrollment and participating in these SHOPs, based on beginning on or after January 1, 2018 coverage effective dates, including their current practices, and consistent and to introduce those requirements in waiting periods, for newly qualified with the market rules set forth in a new § 155.731. To reflect the proposal employees. However, the amendments §§ 147.104 and 147.106, and otherwise that the requirements currently in we proposed at § 155.716 would remove applicable State law. § 155.730 would apply only for plan the requirement for SHOPs to perform We proposed that the special years beginning before January 1, 2018, employee eligibility determinations, enrollment periods specified in we proposed to amend the heading of accept and process single employee § 155.725(j) would continue to be § 155.730 and add paragraph (h), to state SHOP application forms, as well as applicable in the SHOPs for plan years that the section would apply for only verify employee eligibility for plan years beginning on or after January 1, 2018, plan years that begin prior to January 1, beginning on or after January 1,2018. and proposed to include these in 2018. Furthermore, our proposed amendments § 155.726(c). We also proposed that the We are finalizing these policies as not to include paragraphs (c) and (d) of requirements regarding special proposed; the policies will be effective § 155.725 in § 155.726 would remove enrollment periods in § 155.725(j)(3) on the effective date of the final rule. the requirement for SHOPs to maintain would apply for plan years beginning on Comments related to the proposed enrollment records for plan years or after January 1, 2018. However, we approach for SHOP are discussed at the beginning on or after January 1, 2018. proposed to modify the SHOPs’ beginning of section III.D.9 of this rule.

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k. Application Standards for SHOP for new approach to SHOP, we proposed l. Termination of SHOP Enrollment or Plan Years Beginning on or After not to reference a model single Coverage (§ 155.735) January 1, 2018. (§ 155.731) employee application. The model single employer application with the elements Section 155.735 outlines requirements Section 155.730 describes the related to terminations of SHOP requirements for employer and described in proposed § 155.731(b) has been updated to reflect these changes.59 coverage or enrollment. Under our employee applications in the SHOPs. proposed approach, described in detail We proposed to modify these Paragraph (g) of § 155.730 describes additional application safeguards for in the preamble to earlier sections of requirements for plan years beginning this final rule, the process of completing on or after January 1, 2018, and to SHOP employer and employee applications, which we proposed to enrollments, as well as terminating introduce these modified requirements coverage, could be completed by in § 155.731. With the exception of the maintain in § 155.731(f) with minor amendments to reflect the proposal to issuers, and would not be required to be proposed changes to the requirements completed by SHOPs operating in a described here, the requirements would eliminate the requirement to collect a single employee application. We also leaner fashion under the flexibilities remain the same as in § 155.730. provided for in this rule, like the FF– In accordance with our approach proposed in new paragraph (g) to state that § 155.731 would only be applicable SHOPs. Issuers would be expected to allowing SHOPs to operate in a leaner comply with otherwise applicable State fashion for plan years beginning on or for plan years beginning on or after January 1, 2018. and Federal law regarding terminating after January 1, 2018, effective as of the coverage, the timelines and effective We are finalizing these policies as effective date of this rule, QHP issuers dates for termination, and any notice proposed. These changes will become would complete the process of enrolling requirements, including those at effective as of the effective date of this qualified employees into coverage in §§ 147.106 and 156.285. Accordingly, rule. SHOPs that will operate in a leaner we proposed that this section would be fashion, like the FF–SHOPs. In those Comment: One commenter expressed applicable for only plan years beginning SHOPs it would not be necessary for a concern that our proposals to approve prior to January 1, 2018, as described in SHOP to collect information necessary alternative applications will be the proposed amendment to the heading for purchasing coverage. Therefore, we burdensome, since applications are and new paragraph (h), effective on the proposed to modify the information reviewed by the State. effective date of this rule. SHOPs collection requirements related to the Response: Section 155.731(b) maintaining current enrollment single employer application to require discusses the application an employer functions were encouraged to set SHOPs to collect only information that submits to the SHOP for the purposes of termination guidelines and distribute would be necessary for SHOPs to determining eligibility to participate in notices for terminations based on determine employer eligibility to a SHOP. No State review is required nonpayment of premiums or loss of participate in the SHOP under under § 155.731(b) (although a State employee eligibility, unless State law § 155.710(b). To more closely align the Exchange could perform such a review, requires QHP issuers to send the description of the data elements at its option, for its SHOP). The notices. Because SHOPs, such as the collected with those standards for information that SHOPs are required to FF–SHOPs, would no longer be required eligibility to participate, we proposed to collect under these rules is minimal. to enroll groups into a SHOP QHP, they require the SHOP to collect the HHS does not believe that additional would no longer be required to maintain employer name and address of the information to determine an employer’s the ability to terminate coverage. We employer’s locations; information eligibility to participate in a SHOP is believe new §§ 155.716 and 157.206 sufficient to confirm that the employer necessary, and therefore maintains the sufficiently address terminations of is a small employer; the Employer ability to review any alternate eligibility for participation in a SHOP. Identification Number; and information application a SHOP may use to We are finalizing these policies as sufficient to confirm that the employer determine an employer’s eligibility to proposed. Comments related to the is offering, at a minimum, all full-time participate in a SHOP. This section is proposed approach for SHOP are employees’ coverage in a QHP through being finalized as proposed. a SHOP. SHOPs could collect other discussed at the beginning of section Comment: We received one comment III.D.9 of this rule. information, at their option subject to requesting clarification that State the limitations in § 155.716(c)(2) and Exchanges can meet § 155.731(e)(2) by m. SHOP Employer and Employee § 155.731(f). making an application available for Eligibility Appeals Requirements for Paragraph (c) of § 155.730 requires the download on a website as opposed to Plan Years Beginning Prior to January 1, use of a single employee application. implementing an interactive web 2018 (§ 155.740) We proposed that this requirement application portal. As discussed in the following section, would not apply for SHOP beginning for Response: Section 155.730(e)(2) does we proposed to modify the regulatory plan years starting on or after January 1, not currently distinguish whether an requirements regarding employer and 2018, as the information collected in employer application be available for employee eligibility appeals in SHOP this application would no longer be download on an internet website as for plan years beginning on or after necessary, since the SHOP would no opposed to through an interactive web January 1, 2018, and to introduce those longer be required to process application portal on an internet modified requirements in a new employees’ enrollment. website, so long as the tools to file an Section 155.730(d) permits a SHOP to § 155.741. To reflect the proposal that application be available on an internet use a model single employer application the requirements currently in § 155.740 website. We did not make any changes and model single employee application would apply only for plan years to this language in § 155.731(e)(2). provided by HHS, and § 155.730(e) beginning before January 1, 2018, permits the use of HHS-approved effective on the effective date of this 59 Available at https://www.cms.gov/CCIIO/ rule, we proposed to amend the heading alternatives to these model applications. Programs-and-Initiatives/Health-Insurance- We also proposed to maintain these Marketplaces/Downloads/SHOP-Eligibility- of § 155.740 and add paragraph (p), to options, but for consistency with the Determination-Form.pdf. state that the section would apply only

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for plan years that begin prior to January of the PPACA directs HHS to operate an HHS to leverage the systems established 1, 2018. Exchange within the State. Accordingly, for the FFEs to perform certain We are finalizing these policies as in § 156.50(c), we specified that a Exchange functions, and to enhance proposed. Comments related to the participating issuer offering a plan efficiency and coordination between proposed approach for SHOP are through an FFE or SBE–FP must remit State and Federal programs. discussed at the beginning of section a user fee to HHS each month that is Accordingly, in § 156.50(c)(2), we III.D.9 of this rule. equal to the product of the monthly user specified that an issuer offering a plan fee rate specified in the annual HHS n. SHOP Employer and Employee through an SBE–FP must remit a user notice of benefit and payment Eligibility Appeals Requirements for fee to HHS, in the timeframe and parameters for FFEs and SBE–FPs for Plan Years Beginning on or After manner established by HHS, equal to the applicable benefit year, and the January 1, 2018 (§ 155.741) the product of the monthly user fee rate monthly premium charged by the issuer specified in the annual HHS notice of Section 155.740 describes the SHOP for each policy under the plan where benefit and payment parameters for eligibility appeals process for employers enrollment is through an FFE or SBE– SBE–FPs for the applicable benefit year, and employees. These provisions FP. unless the SBE–FP and HHS agree on an describe the applicable definitions, the OMB Circular No. A–25R establishes alternative mechanism to collect the general requirements to provide for Federal policy regarding user fees; it funds from the SBE–FP or State instead appeals, and employers’ and employees’ specifies that a user fee charge will be of direct collection from the SBE–FP rights to appeal an eligibility assessed against each identifiable issuers. The benefits provided to issuers determination from the SHOP. recipient for special benefits derived in SBE–FPs by the Federal government To continue to provide for employer from Federal activities beyond those will include use of the Federal eligibility appeals, we proposed to add received by the general public. As in Exchange information technology and new § 155.741, mirroring § 155.740, benefit years 2014 through 2018, issuers call center infrastructure used in with the following exceptions. Because seeking to participate in an FFE in the connection with eligibility we proposed elsewhere that the 2019 benefit year will receive two determinations for enrollment in QHPs requirement to provide employees with special benefits not available to the and other applicable State health eligibility determinations and the general public: (1) The certification of requirement in § 155.715(f) regarding their plans as QHPs; and (2) the ability subsidy programs, as defined at section notification of employee eligibility to sell health insurance coverage 1413(e) of the PPACA, and enrollment would no longer apply in plan years through an FFE to individuals in QHPs under § 155.400. As previously beginning on or after January 1, 2018, determined eligible for enrollment in a discussed, OMB Circular No. A–25R we proposed not to include a paragraph QHP. These special benefits are established Federal policy regarding mirroring § 155.740(d), which describes provided to participating issuers user fees, and specified that a user employees’ rights to appeal. We also through the following Federal activities charge will be assessed against each proposed to omit other references to for the 2019 benefit year in connection identifiable recipient for special benefits employee appeal rights, to add with the operation of FFEs: derived from Federal activities beyond references to provide for appeals of • Provision of consumer assistance those received by the general public. terminations of eligibility to participate tools; The user fee rate for SBE–FPs is in a SHOP, and to update cross- • Consumer outreach and education; calculated based on the proportion of references as applicable. • Management of a Navigator FFE costs that are associated with the We proposed in paragraph (o) that the program; FFE information technology provisions of § 155.741 would only be • Regulation of agents and brokers; infrastructure, the consumer call center • applicable to plan years beginning on or Eligibility determinations; infrastructure, and eligibility and • Enrollment processes; and enrollment functions, and allocating a after January 1, 2018, effective on the • effective date of this rule. Certification processes for QHPs share of those costs to issuers in the We are finalizing these policies as (including ongoing compliance relevant SBE–FPs. A significant portion proposed. Comments related to the verification, recertification and of expenditures for FFE functions are proposed approach for SHOP are decertification). associated with the information OMB Circular No. A–25R further discussed at the beginning of section technology, call center infrastructure, states that user fee charges should III.D.9 of this rule. and eligibility determinations for generally be set at a level that is enrollment in QHPs and other E. Part 156—Health Insurance Issuer sufficient to recover the full cost to the applicable State health subsidy Standards Under the Affordable Care Federal government of providing the programs as defined at section 1413(e) Act, Including Standards Related to service when the government is acting of the PPACA, and personnel who Exchanges in its capacity as sovereign (as is the perform the functions set forth in case when HHS operates an FFE). 1. FFE and SBE–FP User Fee Rates for § 155.400 to facilitate enrollment in Activities performed by the Federal the 2019 Benefit Year (§ 156.50) QHPs. Based on this methodology, we government that do not provide issuers Section 1311(d)(5)(A) of the PPACA proposed to charge issuers offering participating in an FFE with a special QHPs through an SBE–FP a user fee rate permits an Exchange to charge benefit are not covered by this user fee. of 3.0 percent of the monthly premium assessments or user fees on participating Based on estimated contract costs, charged by the issuer for each policy health insurance issuers as a means of enrollment and premiums for the 2019 under plans offered through an SBE–FP. generating funding to support its benefit year, we proposed to maintain operations. In addition, 31 U.S.C. 9701 the 2019 benefit year user fee rate for all This fee would support FFE operations permits a Federal agency to establish a participating FFE issuers at 3.5 percent associated with providing the functions charge for a service provided by the of total monthly premiums. We sought described above. We sought comment agency. If a State does not elect to comment on this proposal. on this proposal. operate an Exchange or does not have an State Exchanges on the Federal We are finalizing the FFE and SBE– approved Exchange, section 1321(c)(1) platform enter into an agreement with FP user fees rates at 3.5 and 3.0 percent

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of monthly premiums, respectively, as reductions amounts loaded to silver allocate a certain share of the State’s proposed. premiums ought to also reduce the user assessments on various functions, and As we describe elsewhere in this rule, fee rate. Some of these commenters also we are not requiring the SBE–FPs to set for plan years beginning on or after stated that HHS has not provided SBE– the State assessment at any specific rate. January 1, 2018, effective on the FPs with enrollment data or access to If SBE–FP States require more than 0.5 effective date of this rule, we are HealthCare.gov back-end customer tools percent of premiums to carry out State removing employee eligibility, premium that the SBE–FPs could use to improve functions for the 2019 benefit year, one aggregation, and online enrollment outreach and enrollment activities at the option for the SBE–FP States could be functionality through the FF–SHOPs for State level. Commenters suggested that to assess a higher State charge on FFE and SBE–FP SHOP issuers. Given HHS maintain the 2018 benefit year issuers, and another option is for the the changes to the functionality for the SBE–FP user fee rate of 2 percent given SBE–FP States to assess a charge more FF–SHOPs, HHS will not provide these the impact of user fee rates on market broadly on issuers rather than just on special benefits through the FF–SHOPs premiums. issuers offering QHPs on the respective or SBE–FP SHOPs after the effective Response: The final SBE–FP user fee SBE–FPs. We are setting the 2019 SBE– date of the rule. Therefore, we proposed rate for the 2019 benefit year of 3.0 FP user fee rate at 3.0 percent of that HHS would not assess a user fee on percent of premiums is based on HHS’s premiums charged on participating issuers offering QHPs through FF– calculation of the percent of contract issuers in SBE–FPs to recover the SHOPs or SBE–FP SHOPs because these costs of the total FFE functions utilized proportion of costs to the Federal user fees are only charged to issuers by SBE–FPs—the costs associated with government for the benefits associated who receive special benefits from the information technology, call center with SBE–FPs, as required under OMB enrolling individuals through the infrastructure, and eligibility Circular No. A–25R. We continue to Federal platform. In instances where determinations for enrollment in QHPs encourage and support States in enrollment did occur through the and other applicable State health pursuing the SBE–FP model, in Federal platform, for example, for plan subsidy programs. We have calculated assessing charges on participating years beginning prior to the effective the total costs allocated to SBE–FP issuers, or otherwise, to recover the date of the final rule, HHS will continue functions and enrollment and premium costs associated with the State’s charging SHOP issuers monthly FFE or estimates to yield a user fee rate of 3.0 functions and most effectively carry out SBE–FP user fees, as applicable. We are percent for SBE–FP issuers benefiting those functions. We do not believe the finalizing this policy as proposed. from functions provided by the Federal total Federal charge assessed on FFE Comment: Commenters noted the FFE platform. We believe issuers offering issuers are appropriately compared to user fee rate should decrease over time, QHPs through the Federal platform, the total State and Federal charge particularly given the reduction in either the FFEs or SBE–FPs, ought to be assessed on SBE–FP issuers because outreach and education activities that charged proportionally for the special SBE–FPs provide the benefit of more HHS conducts. Additionally, benefits provided by the Federal proximately engaging issuers and commenters noted that the collection platform. HHS has provided SBE–FPs 2 consumers. and allocation of the user fees should be years to transition to the full rate. made more transparent. Other Additionally, although HHS reduced its 2. Essential Health Benefits Package commenters also noted that HHS should outreach and education costs, we do not Section 2707(a) of the PHS Act, as allocate a greater portion of the user fees charge SBE–FPs for these costs as added by the PPACA, directs health to outreach and education programs. outreach and education activities are insurance issuers that offer non- Response: The FFE and SBE–FP user SBE–FPs’ responsibility, and therefore grandfathered health insurance coverage fee rates for the 2019 benefit year are the proportion of Federal platform costs in the individual or small group market based on expected total costs to offer the associated with SBE–FP functions to ensure that such coverage includes special benefits to issuers offering plans increased slightly compared to prior the EHB package, which is defined on FFEs or SBE–FPs and evaluation of years. We also continuously collaborate under section 1302(a) of the PPACA to expected enrollment and premiums for with our SBE–FP partners to share data include coverage that provides for the the 2019 benefit year. These estimates within our information disclosure EHB defined by the Secretary under yielded an FFE user fee rate of 3.5 agreements, and welcome continued section 1302(b) of the PPACA; limits percent of premiums and an SBE–FP conversations with SBE–FPs on their cost sharing in accordance with section user fee rate of 3.0 percent of premiums. data needs. 1302(c) of the PPACA; and provides We reiterate that under OMB Circular Comment: Commenters also noted either the bronze, silver, gold, or No. A–25R, collections are only spent that HHS setting the SBE–FP user fee platinum level of coverage, or is a on user fee eligible activities. We will rate at 3 percent requires State entities catastrophic plan under sections continue to examine cost estimates for to operate a referral hotline, consumer 1302(d) and (e) of the PPACA. Section the special benefits provided to issuers assistance, QHP rate review and 1302(b) of the PPACA states that the offering QHPs on the FFEs and SBE–FPs certification, legal and finance Secretary is to define EHB, except that for future benefit years. Additionally, operations, auditing and other functions EHB must include at least the following outreach and education efforts will be with collections based on a State user general categories and the items and evaluated annually and funded at the fee rate of 0.5 percent of premiums, services covered within the categories: appropriate level. which would not be feasible, or require (1) Ambulatory patient services; (2) Comment: Some commenters did not SBE–FPs to increase assessments on emergency services; (3) hospitalization; support the proposed SBE–FP user fee carriers. Commenters noted keeping a (4) maternity and newborn care; (5) rate, stating the proportion of FFE costs lower user fee rate for the SBE–FP mental health and substance use allocated to SBE–FP functions do not model would likely increase States’ disorder services including behavioral represent market value, the fee is take-up of these models and enrollment health treatment; (6) prescription drugs; overstated particularly in context of due to the resulting slightly lower (7) rehabilitative and habilitative reduced outreach and education increase in premiums. services and devices; (8) laboratory functions by the Federal platform, and Response: As we have previously services; (9) preventive and wellness increased premiums due to cost-sharing stated, we are not requiring SBE–FPs to services and chronic disease

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management; and (10) pediatric by aggregate enrollment that is offered Federal default definition of EHB would services, including oral and vision care. to all health-benefits-eligible Federal be implemented in the pursuit of Additionally, section 1302(b)(2) of the employees under 5 U.S.C. 8903, or the seeking arbitrary benefit limits, even at PPACA states that the Secretary must coverage plan with the largest insured the cost of inferior health outcomes. ensure that the scope of EHB for the 10 commercial non-Medicaid enrollment Some commenters expressed concern EHB categories be equal to the scope of offered by a health maintenance over diminishing the State’s flexibility benefits provided under a typical organization operating in the State. in defining their own EHB, especially employer plan, as determined by the States were required at § 156.110 to since other proposals with regard to Secretary. Furthermore, section supplement their base-benchmark plan EHB concentrated on giving additional 1302(b)(2) of the PPACA states, in from § 156.100 to ensure the 10 EHB flexibility to the States. These defining and revising EHB, that the categories were being covered to commenters also expressed concern Secretary is to submit a report to the establish the State’s EHB-benchmark over requiring States to defray the costs appropriate committees of Congress plan. Section 156.110 also ensures that of benefits in excess of a Federal containing a certification from the CMS the EHB-benchmark plan meets the standard. Chief Actuary that such EHB are equal standards of nondiscrimination and Many commenters expressed support in scope to the benefits provided under balance of benefits, and allows for a Federal default EHB definition if a typical employer plan. In defining and habilitative services to be determined by such a standard represented a minimum revising the 10 EHB categories, the the State. level of benefits required in an EHB- Secretary must also provide notice and We believe that States should have benchmark plan, rather than a an opportunity for public comment. additional choices with respect to maximum level of benefits. Commenters Additionally, section 1302(b)(4)(G) and benefits and affordable coverage. As noted that plans should include a wide (H) of the PPACA require the Secretary such, we proposed to provide States array of benefits to account for the to periodically review and update the with additional flexibility in their diverse needs of the population at large. definition of EHB and provide a report selection of an EHB-benchmark plan for Other commenters supported a Federal to Congress and the public that contains plan year 2019 and later plan years. In default EHB definition to the extent that assessments related to the need to addition to granting States more certain benefits would be included in update the definition of EHB. flexibility regulating their markets, we such a definition. Section 1302(b)(4) of the PPACA believed these changes would permit Most commenters opposed a Federal requires the Secretary, in defining the States to modify EHB to increase default definition of EHB as it pertains EHB, to: (1) Ensure that such EHB affordability of health insurance in the to a national prescription drug benefit, reflect an appropriate balance among individual and small group markets noting that States and issuers are best the categories so that benefits are not beginning in 2019. We proposed that the positioned to evaluate and respond to unduly weighted toward any category; current EHB-benchmark plan selection prescription drug needs. Many of these (2) not make coverage decisions, would continue to apply for any year for commenters expressed concerns similar determine reimbursement rates, which a State does not select a new to those raised regarding a general establish incentive programs, or design EHB-benchmark plan under this Federal default EHB definition: benefits in ways that discriminate proposal. Concerns that such a standard would, in against individuals because of their age, In the preamble of the proposed rule, the pursuit of arbitrary benefit limits, disability, or expected length of life; (3) we stated that we were considering have a negative impact on health take into account the health care needs establishing a Federal default definition outcomes by inhibiting the availability of diverse segments of the population, of EHB for plan years further in the of needed drugs; establish a maximum including women, children, persons future that would allow States level of benefits for EHB-benchmark with disabilities, and other groups; (4) continued flexibility to adopt their own plans; diminish the States’ flexibility to ensure the health benefits established as EHB-benchmark plans, provided they define EHB; and increase the defrayals essential not be subject to denial to defray costs that exceed the Federal required by States. individuals against their wishes on the default. We understood that in Some commenters noted that a basis of the individuals’ age or expected developing this type of default national prescription drug benefit length of life or of the individuals’ definition there are trade-offs in standard would require continuous and present or predicted disability, degree of adjusting benefits and services. We gave frequent updating to account for medical dependency, or quality of life; an example of establishing a national changes in clinical guidelines and drug and (5) provide that a QHP shall not be benchmark plan standard for innovation. These commenters treated as providing coverage for EHB prescription drugs that could balance supported a national prescription drug unless it meets certain requirements for these tradeoffs and provide a consistent benefit standard that uses a qualitative coverage of emergency services. prescription drug default standard approach reliant upon Pharmacy & To implement section 1302(b) of the across States. We solicited initial Therapeutics Committees to respond to PPACA, HHS defined EHB based on a comments on this type of long-term such rapid changes, rather than a benchmark plan approach, which approach and the trade-offs in adjusting standard based on providing a provided at § 156.100 for the States’ benefits from the current EHBs with a minimum number of drugs per category selection from one of 10 base- plan to solicit further comments in the or class. benchmark plans, including the largest future. A few commenters supported a health plan by enrollment in any of the Comment: Many commenters national prescription drug benefit, three largest small group insurance requested more detail on a Federal noting that multi-State issuers face products by enrollment, any of the default definition of EHB, with some complexity dealing with minimum drug largest three employee health benefit commenters suggesting the publication counts which vary widely across EHB- plan options by enrollment offered and of a white paper to discuss such a policy benchmark plans, with no rational generally available to State employees in more detail. medical justification for the variation. in the State, any of the largest three Most commenters opposed a Federal Some commenters expressed concern national Federal Employees Health default definition of EHB. Many about the impact of a Federal Benefits Program (FEHBP) plan options commenters were concerned that a prescription drug benefit on the ability

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of entities to negotiate drug prices. One flexibility to update their EHB- benchmark plan from another State commenter noted that a Federal default benchmark plans more frequently and to using this option, the selecting State EHB definition for prescription drugs select among more options. Specifically, would still be required to defray the cost would stifle innovation due to we proposed that a State may change its of any benefits included in that State’s uncertainty over whether a new drug EHB-benchmark plan by: (1) Selecting EHB-benchmark plan that are benefits would be covered. the EHB-benchmark plan that another mandated by the selecting State after Response: Our intention is to better State used for the 2017 plan year 60 December 31, 2011, and that are subject align medical risk in insurance products under § 156.100 and § 156.110; (2) to defrayal under the current by balancing costs to the scope of replacing one or more EHB categories of regulations.62 For example, if State A benefits. We will take these comments benefits under § 156.110(a) in its EHB- selects the EHB-benchmark plan of State under consideration as we consider this benchmark plan used for the 2017 plan B, State A would be required to defray policy. In order to avoid market year with the same categories of benefits the cost of any benefits included in instability and inefficiencies for States from another State’s EHB-benchmark State B’s EHB-benchmark plan that are that have used the expanded flexibilities plan used for the 2017 plan year under required to be provided by State A’s regarding EHB that we are finalizing in § 156.100 and § 156.110; or (3) action after December 31, 2011, and that this rule and issuers in those States, it otherwise selecting a set of benefits that are subject to defrayal under current is our intent that any Federal default would become the State’s EHB- regulations. We solicited comments on standard would not require a State to benchmark plan, provided that the EHB- this proposal, including on the make immediate changes to its EHB- benchmark plan does not exceed the application of the State mandate policy benchmark plan within 3 years generosity of the most generous plan under this proposal and on whether following a State change. among a set of comparison plans. Under other flexibilities are needed by States this third option, the comparison plans under this proposed option. a. State Selection of Benchmark Plan for would be the State’s EHB-benchmark Plan Years Beginning Prior to January 1, Option 2: Replace Category or plan used for the 2017 plan year and the 2020 (§ 156.100) Categories From Another State’s EHB- plans described in § 156.100(a)(1) for Benchmark Plan To reflect the proposed options in the 2017 plan year, supplemented as § 156.111 for States to adopt new EHB- necessary under § 156.110. These plans Under the second option, we benchmark plans for plan years 2019 would include the largest health plan by proposed that a State be allowed to and later, we proposed to make enrollment in each of the three largest partially replace its current EHB- conforming changes to § 156.100 to small group insurance products by benchmark plan, using EHB-benchmark explicitly state that the selection process enrollment from the State’s 2017 base- plans used by other States for the 2017 in § 156.100 applies only through plan benchmark plan options.61 Under any of plan year. Under this option, we years beginning in 2018, and § 156.111 the available three options, we proposed proposed that a State may replace any applies for plan years beginning after that a State could change its EHB- EHB category or categories of benefits in its EHB-benchmark plan from the 10 2018. Because we are finalizing benchmark plan in any given year, not required EHB categories with the same § 156.111 to apply for plan years 2020 only in the years that HHS specified. At category or categories of benefits from and later, we are not finalizing these the same time, this proposed policy another State’s EHB-benchmark plan conforming changes as proposed, but would also allow States that prefer to used for the 2017 plan year. For are instead making changes to § 156.100 maintain their current EHB-benchmark example, a State may select the to state that the selection process in plans to do so without action. prescription drug coverage from another § 156.100 applies only through plan Option 1: Select Another State’s EHB- State’s EHB-benchmark plan (which years beginning in 2019, and § 156.111 Benchmark Plan might include a different formulary drug applies for plan years beginning on or count) and a third State’s EHB- after January 1, 2020. Under the first option, we proposed benchmark plan hospitalization Comment: A few commenters that a State be permitted to select one category. Similar to the first option, we commented on the proposal to make of the EHB-benchmark plans used for proposed that benefits mandated by conforming changes to § 156.100 as a the 2017 plan year by another State. We State action prior to or on December 31, result of our proposed changes to did not propose to change the State 2011, could continue to be considered § 156.111. These commenters generally mandate policy at § 155.170 under this option. Under this proposed policy, we EHB under this proposal in accordance did not support the proposed policy of with § 155.170, and would not require § 156.111 and supported retaining the proposed that benefits mandated by State action prior to or on December 31, the State to defray their costs. However, current benchmark plan options at if a State uses this option to replace one § 156.100 that provided benchmark plan 2011 could continue to be considered EHB under § 155.170, and would not or more categories of its EHB- options at the State level. benchmark plan used for the 2017 plan require the State to defray the costs. Response: Since we are finalizing the year with a category or categories of Conversely, if a State selects an EHB- new options for a State’s EHB- benefits from another State’s EHB- benchmark plan at § 156.111 starting for benchmark plan used for the 2017 plan plan year 2020, we are finalizing 60 The States’ EHB-benchmark plans used for the 2017 plan year are based on plans from the 2014 year, the selecting State would be conforming changes to § 156.100, to plan year, but we occasionally refer to them as 2017 required to defray the cost of any reflect § 156.111. plans because these plans are applicable as the benefits included in the categories of States’ EHB-benchmark plans for plan years benefits from the other State’s EHB- b. State Selection of EHB-Benchmark beginning in 2017. Plan for Plan Years Beginning on or 61 The Essential Health Benefits: List of the benchmark plan that are mandated by After January 1, 2020 (§ 156.111) Largest Three Small Group Products by State for the selecting State’s action after 2017 is available at https://www.cms.gov/CCIIO/ i. States’ EHB-Benchmark Plan Options Resources/Regulations-and-Guidance/Downloads/ 62 Under § 155.170, the State must make (§ 156.111(a)) Top3ListFinal-5-19-2015.pdf. States’ EHB- payments to defray the cost of additional required benchmark plans used for the 2017 plan year are benefits either to an enrollee, as defined in § 155.20, We proposed to add new § 156.111, able at https://www.cms.gov/CCIIO/Resources/Data- or directly to the QHP issuer on behalf of the which would provide States with the Resources/Downloads/Final-List-of-BMPs_4816.pdf. enrollee.

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December 31, 2011 and that are subject defrayal. However, if a State selects its diminish care, increase or shift costs or to defrayal under current regulations. EHB-benchmark plan using this option, affect issuer competition. For example, if State A replaces a the State must continue to defray the Other commenters believed that the category of benefits in its EHB- cost of any benefits mandated by State proposed policy was inconsistent with benchmark plan with a category of action after December 31, 2011 that are the statutory requirements that the benefits from State B’s EHB-benchmark subject to defrayal under current Secretary define EHB and that the plan, State A must defray the cost of any regulations. For example, if the State Secretary ensure other EHB consumer benefits in that category mandated by selects a set of benefits to become its protections under section 1302(b)(2), State A after December 31, 2011 that are EHB-benchmark plan under paragraph (3), and (4) of the PPACA are included in the replacement category of (a)(3), any benefits mandated by that incorporated into the definition of EHB. benefits and that are subject to defrayal State after December 31, 2011 that are These commenters believed that the under current regulations. subject to defrayal under current Secretary has no authority to delegate defining EHB or its parameters to States Option 3: Select a Set of Benefits To regulations would not be considered EHB, and the State would be required to or issuers. Commenters also believed Become the State’s EHB-Benchmark that the proposed options allowed Plan defray the cost of any such benefits included in the State’s EHB-benchmark States to select an EHB-benchmark plan Lastly, under the third option, we plan under this proposed option. from among an endless set of options, proposed that a State be permitted to We solicited comments on all of the whereas the prior policy allowed a select a set of benefits that would proposals, including on whether to preset list of 10 plan options per State, become its EHB-benchmark plan using a allow a State to select its EHB- with most options being from the State different process, so long as the new benchmark plan from any of the 10 in which the plan was applying. Some EHB-benchmark plan does not exceed previous base-benchmark plan options commenters also believed that the the generosity of the most generous available to the State or other States proposed policy was inconsistent with among a set of comparison plans. Under under § 156.100, supplemented as the statutory requirement that the this option, the set of comparison plans necessary under § 156.110, on whether Secretary update EHB based on gaps in would be the State’s EHB-benchmark a different approach is needed to defray coverage or changes in the evidence plan used for the 2017 plan year and the the cost of any benefits mandated by identified in the Secretary’s report to plans described in § 156.100(a)(1) that State action, on whether other Congress as established at section were available as base-benchmark plan 1302(b)(4)(H) of PPACA. Some of these flexibilities are needed by States under options for the 2017 plan year, commenters also noted that this report the proposed options, on our proposed supplemented as necessary under has not been completed. § 156.110. These plans would include approach to limit a State’s new EHB- Response: As described in the EHB the largest health plan by enrollment in benchmark plan under Option 3, such Final Rule, we originally established the each of the three largest small group that it does not exceed the generosity of benchmark plan policy to ensure that insurance products by enrollment from the comparison plans, and on whether EHB is equal to the scope of benefits the State’s base-benchmark options for other options should be provided to provided under a typical employer plan the 2017 plan year. We proposed that States to select their EHB-benchmark and in recognition that the typical the State would determine if its plans beyond the three proposed employer plans differ by State. proposed EHB-benchmark plan does not options. We are finalizing these new Specifically, the Secretary balanced exceed the generosity of the most EHB-benchmark plan options as these directives, and minimized market generous of a set of comparison plans proposed, with one amendment. As disruption, by directing plans to offer using an actuarial certification, further discussed in the comments and the 10 statutory EHB categories while developed by an actuary who is a responses below, we are extending the allowing the State to select the specific member of American Academy of proposed requirements at details of their EHB coverage from a set Actuaries, in accordance with generally § 156.111(a)(3)(i) and (ii) that ensure of reference plans. Accordingly, States accepted actuarial principles and that the State’s new EHB-benchmark maintained their traditional role in methodologies. For this actuarial plan does not exceed the generosity of defining the scope of insurance benefits certification, we proposed that the State the most generous among a set of and exercised that authority by selecting could determine generosity in the same comparison plans to all of the State’s a plan that reflects the benefit priorities manner as we would use to measure options to select a new EHB-benchmark of that State, within the bounds of the whether the plan provides benefits that plan at § 156.111(a). We are finalizing definition of EHB set by the Secretary.63 are equal in scope of benefits provided these requirements at § 156.111(b)(2)(ii). This deference to States within the under a typical employer plan, Comment: Some commenters definition established by the Secretary described later in this section. supported the proposed EHB- continues under the policies finalized in We also recognized that the increased benchmark plan options for States this rule. flexibility offered to States under this because they offer increased State We believe that States should have proposed option to define an EHB- flexibility through additional options for additional choices with respect to benchmark plan could allow a State to States. Many commenters did not benefits, which may foster innovation in embed any desired benefit mandate into support the proposed EHB-benchmark plan design and greater access to the EHB-benchmark plan, without any plan policy or supported retaining the coverage, and provide States with a requirement to defray the obligation. For current policy, and noted that it already mechanism for affecting affordability. this reason, we proposed to apply the allows State flexibility. Many of these This approach may balance these benefit mandate defrayal policy under commenters were concerned that States considerations in manners different § 155.170 to this option. Specifically, we would decrease EHB benefits as a result from the balance achieved under the proposed that benefits mandated by of the proposed policy, or that issuers previous benchmark plans. The State action prior to or on December 31, would not cover benefits that are not Secretary is defining an expanded set of 2011 could continue to be considered EHB. Some commenters were concerned options from which the State can select EHB under this proposal according to that the options would create a § 155.170, and would not require State patchwork of benefit designs that could 63 EHB Rule, 78 FR at 12843. February 23, 2013.

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its EHB-benchmark plan, allowing the Exchanges. These QHP markets have Other commenters noted that the State to select the specific details of that seen significant changes from year to second option allows the State to define plan. This policy recognizes the need year since their inception, with the EHB by selecting the least generous for increased State flexibility beyond number of issuers offering plans in each benefits for each category, thus creating that which the original policy allowed. market changing on an annual basis and a standard that does not resemble any For this reason, we are finalizing the the number of enrollees in these plans existing plan in the market today. new options for a State’s EHB- fluctuating. Furthermore, the frequent Commenters were similarly concerned benchmark plan, along with additional modifications to EHB policies and other that the third option could allow a State requirements for the State’s selection as related Federal benefit policies, such as to greatly reduce the generosity of detailed later in this preamble. We guidance on complying with the Paul coverage, even though the definition believe these requirements, when taken Wellstone and Pete Domenici Mental would still require the coverage of the together, provide States with significant Health Parity and Addiction Equity Act 10 EHB categories. Some commenters flexibility while appropriately limiting of 2008 (MHPAEA) and preventive were concerned that the third option the range of choices, thereby fulfilling services regulations, have not allowed was too broad and did not ensure the Secretary’s obligation to define EHB. these plans’ benefit structures to consumer protections to ensure the Specifically, the requirement that a stabilize enough for conclusive analysis. comprehensive scope of benefits. State’s EHB-benchmark plan provide a Since the PPACA only requires this Response: We are not persuaded that scope of benefits that is equal to, or report to Congress to be conducted the new options will create a race for greater than, to the extent any periodically, and we do not believe that States to establish the least generous supplementation is required to provide conducting this report at this time will plan possible because all States’ EHB- coverage within each EHB category at establish meaningful conclusions, this benchmark plans will be required to § 156.110(a), the scope of benefits report will not be completed at this include coverage for all 10 EHB provided under a typical employer plan, time. We intend to conduct this report categories of benefits, and the State will as defined at § 156.111(b)(2), establishes once the market has stabilized, which be required to confirm its EHB- a minimum scope of benefits that is we believe will be furthered by the benchmark plan includes coverage for required to be covered as EHB. policy we are finalizing in this rule. each EHB category in accordance with Furthermore, the requirement that the Comment: Many commenters were § 156.111(e)(1). Section 156.111(e)(1) EHB-benchmark plan cannot exceed the concerned that the proposed EHB- also requires States to confirm that its generosity of the most generous among benchmark plan options would create a new EHB-benchmark plan meets the a set of comparison plans, which are race to the bottom among States’ scope applicable requirements of § 156.111(b) those group market plans that comprise of benefits for their EHB-benchmark on scope of benefits, including that the the basis for the scope of benefits under plans. These commenters were State’s EHB-benchmark plan provide a the current definition of EHB, further especially concerned that these benefit scope of benefits that is equal to, or limits the range of benefits that can be designs would not meet the needs of greater than, to the extent any considered EHB. Together with the vulnerable populations, would increase supplementation is required to provide other requirements specified at costs to consumers, and would reduce coverage within each EHB category at § 156.111(b)(2), these requirements the value of coverage. Some commenters § 156.110(a), the scope of benefits provide States with flexibility to adjust were concerned that benchmark plans provided under a typical employer plan their States’ EHB-benchmark plan selected under one of the first two in accordance with § 156.111(e)(2).64 within a limited range. options would not reflect plans in the Through those requirements, the At the same time, this policy also State or meet the needs of beneficiaries options at § 156.111(a) do not allow a allows a State to retain its current EHB- in that State. Some commenters were State to substantially reduce the level of benchmark plan. This flexibility was not concerned that these proposed options coverage, and instead allow a State the afforded under the previous policy. In discourage States from selecting more option to adjust its EHB-benchmark fact, the previous default option, which generous coverage, with some was the largest plan by enrollment in commenters stating that if the true goal 64 We are also retaining the current issuer the largest product by enrollment in the of the policy was to increase State requirements related to EHB at §§ 156.115, 156.122, State’s small group market, could vary flexibility, the State should also have and 156.125 and those requirements would between benchmark plan selection the option to increase benefits. continue to apply to all plans subject to the EHB years, creating unnecessary disruption Other commenters were concerned requirements. This includes 45 CFR 156.122(a)(1) that establishes that, generally, a health plan does for States that were unable to select a that the first two options allow States to not provide EHB unless it covers at least the greater benchmark plan. Under the new policy, pick more generous plans, and some of: (1) One drug in every USP category and class; these States, as well as States that do not commenters recommended preventing or (2) the same number of prescription drugs in wish to make changes, will not be States from being able to select an each category and class as the EHB-benchmark plan. Under the current version of the USP required to do so, and will not need to option without being responsible for the Medicare Model Guidelines (MMG) drug take action to prevent the disruption costs of the additional benefits. In classification system used for the EHB drug count caused by a change to the State’s EHB- general, these commenters were at § 156.122(a)(1), this proposal means that all benchmark plan. concerned that the proposed policy plans required to comply with EHB will continue to have to cover at least one drug in the Anti- We are not completing the report to would allow States to select benchmark Addiction/Substance Abuse Treatment Agents Congress and the public on the periodic plans with more generous State (Opioid Reversal Agent) class. Naloxone is review of EHB under section mandates. Other commenters were currently the only active ingredient in the Opioid 1302(b)(4)(G) of the PPACA at this time. concerned that there is significant Reversal Agent class, and as a result all plans required to comply with EHB would be required to We do not believe that a report on EHB variation in benchmark plan coverage of continue to cover at least one form of naloxone at this time will provide conclusive particular services, and some under this proposed policy. This was previously results on the assessments required commenters stated that the goal of addressed in the 2018 Letter to Issuers in the under section 1302(b)(4)(G) of the allowing State flexibility should be Federally-facilitated Marketplaces available at https://www.cms.gov/CCIIO/Resources/Regulations- PPACA, as a large portion of plans secondary to ensuring and-Guidance/Downloads/Final-2018-Letter-to- required to comply with EHB are QHPs comprehensiveness of the benefit Issuers-in-the-Federally-facilitated-Marketplaces- offered both on and off of the package. and-February-17-Addendum.pdf.

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plan to use benefit structures that have protections to ensure that a State’s EHB- plans. These commenters noted that worked well in other States or other benchmark plan selections take into States are only supplementing parts of the employer markets, or account affordability of coverage, by categories of benefits in those plans otherwise innovate benefits within the applying the generosity test proposed in when those categories are missing and range of plans in the employer market. connection with the third option to all are not considering the scope of benefits Because each State has different market three EHB-benchmark plan selection within the category, leading to conditions and demographic options for States. Accordingly, inadequate coverage. Other commenters distributions, a plan that may be the § 156.111(b)(2)(ii) provides that a State wanted to understand how least generous plan in one State may not may not select a new EHB-benchmark supplementation would work under the be the least generous plan in another plan that exceeds the most generous options. State, and for that reason, we are not among a set of comparison plans, no Response: Additional concerned that this policy is going to matter the option used to generate the supplementation of the EHB-benchmark create a race to establish the least EHB-benchmark plan. These plans generally should not be required generous plan. comparison plans include the State’s under the three State EHB-benchmark In short, this flexibility established EHB-benchmark plan used for the 2017 plan selection options being finalized at under § 156.111(a) is not intended to plan year and the plans described in § 156.111(a). For the first option at reduce benefits, but to allow for more § 156.100(a)(1) for the 2017 plan year, § 156.111(a)(1), the selecting State innovative benefits within the current supplemented as necessary under would be selecting another State’s EHB- benefit requirements. This means that a § 156.110.66 We recognize that it may be benchmark plan, which already would State’s EHB-benchmark plan may not possible for a State’s EHB-benchmark be supplemented, as necessary.67 For have the exact same benefits and limits plan to provide a scope of benefits that the second option at § 156.111(a)(2), the as the typical employer plan the State is equal to (or greater than, to the extent State would replace a category or identifies under this policy, but this any supplementation is required to categories of benefit from its current policy will still result in the State’s provide coverage within each EHB EHB-benchmark plan with another EHB-benchmark plan providing a scope category at § 156.110(a)) the scope of State’s EHB-benchmark plan’s category of benefits equal to, or greater than, to benefits provided under a typical or categories of benefits, which already the extent any supplementation is employer plan at § 156.111(b)(2)(i), and would have been supplemented, if required to provide coverage within not meet the generosity standard at necessary, by that other State. each EHB category at § 156.110(a), the § 156.111(b)(2)(ii) (for example, a A State using the third option will scope of benefits provided under a proposed EHB-benchmark plan could need to ensure that its EHB-benchmark typical employer plan, satisfying the satisfy the typical employer plan plan satisfies the requirements being Secretary’s obligations at section requirement but exceed the generosity finalized at § 156.111(b), such as the 1302(b) of the PPACA. Furthermore, as standard because of the way requirements to cover items and described later in this rule, we are supplementation was performed). services in each of the ten statutory finalizing a definition of a typical However, we believe that by extending categories of EHB; to not have benefits employer plan that requires the plan this generosity limit to all selection unduly weighted towards any of those have enrollment and be sold in the options, we are minimizing the categories of benefits; and to provide a State. This definition ensures that opportunity for a State to select EHB in scope of benefits equal to (or greater regardless of the benchmark plan option a manner that would make coverage than, to the extent any supplementation selected by the State under this rule, unaffordable for patients and increase is required to provide coverage within that benchmark plan will be at least Federal costs, while still helping to each EHB category at § 156.110(a)), the equal to the scope of benefits to a ensure that States are ensuring that scope of benefits provided under a popular employer plan that was benefits are equal to the scope of typical employer plan. Since States have previously offered in the State’s benefits provided under a typical been supplementing their EHB- employer plan market. employer plan. benchmark plans since the inception of Furthermore, we encourage States to Comment: Some commenters were the EHB policy, we expect States to be select EHB-benchmark plans that foster concerned that a State would have familiar with categorizing benefits. innovation in plan design that would difficulty knowing what another State’s Comment: Various commenters provide greater access to coverage that EHB-benchmark plan was covering, supported coverage of specific services would ultimately improve affordability. because the benefits or benchmark plan within an EHB category, with some As discussed in the proposed rule, in documentation were not broken into commenters noting that many of the addition to granting States more separate EHB categories. Some services that might be considered for flexibility in regulating their markets, commenters were generally concerned reduction are only a small portion of one of the goals with this policy was to about using the 2017 EHB-benchmark spending. They stated that not covering permit States to modify EHB to increase these services would not meaningfully affordability of health insurance in the 66 The actual number of comparison plans for reduce premiums and would increase or individual and small group markets.65 each State depends on the State’s EHB-benchmark shift costs for the services for the As we also note in our discussion of plan for 2017. Most States will only have three consumers who need them. Other comparison plans as the State’s EHB-benchmark benefits mandated by State action at plan for 2017 is a plan within the options at commenters noted that all of the options § 155.170, we want to ensure that States § 156.100(a)(1). However, a few States will have are linked in part to the 2017 EHB- do not select EHB in a manner that four comparison plans as the State’s EHB- benchmark plans (including the decreases affordability of coverage. benchmark plan for 2017 is not a plan within the generosity standard under Option 3), options at § 156.100(a)(1). The list of plan options and that these are in fact 2014 plans. Therefore, in response to commenters’ at § 156.100(a)(1) for each State for 2017 is available concerns about ensuring that the at https://www.cms.gov/CCIIO/Resources/ Certain commenters were concerned options under § 156.111(a) do not Regulations-and-Guidance/Downloads/ undermine the goal of affordability, we Top3ListFinal-5-19-2015.pdf. Also, the States’ EHB- 67 Information on whether the State benchmark plans used for the 2017 plan year are supplemented its EHB-benchmark plan for 2017 is are incorporating into the regulation available at https://www.cms.gov/CCIIO/Resources/ available at https://www.cms.gov/CCIIO/Resources/ Data-Resources/Downloads/Final-List-of-BMPs_ Data-Resources/Downloads/Final-List-of-BMPs_ 65 82 FR at 51102. 4816.pdf. 4816.pdf.

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that these 2014 plans do not comply what entity has the authority to select and lifetime dollar limit prohibition or with new requirements, such as the the State’s EHB-benchmark plan. We the annual limitation on cost sharing. applicability of requirements under therefore will not dictate which State ii. The Requirements for States’ EHB- MHPAEA or noted that using 2014 entity must act to select a State’s EHB- Benchmark Plans (§ 156.111(b) Through plans in the long term means that EHB benchmark plan, but we may consider (d)) would still be linked to 2014 plans. providing States with additional Comments varied on whether States that technical assistance to aid in their Under the proposed options for States are selecting an EHB-benchmark plan selection under the policy finalized in to select a new EHB-benchmark plan, should be allowed to select from any this rule. we proposed that a State’s EHB- States’ previous EHB-benchmark plans Comment: Many commenters were benchmark plan must meet certain for options § 156.111(a)(1) or (2). A few concerned about the impact of the requirements established under the commenters recommended that HHS proposed policy on the determination of PPACA with regard to EHB coverage, give States additional technical which benefits are subject to the scope of benefits, and notice and assistance. For example, one commenter prohibition of annual and lifetime dollar opportunity for public comment. First, sought clarification on which State limits in section 2711 of the PHS Act, under paragraph (b)(1), we proposed to entity would be authorized to select the as added by the PPACA, and the annual require that the State’s EHB-benchmark State’s EHB-benchmark plan. Certain limitation on cost sharing at section plan provide an appropriate balance of commenters also had concerns about 1302(c) of the PPACA (which is coverage for the 10 EHB categories of provider discrimination under the incorporated into section 2707(b) of the benefits as established at § 156.110(a) proposed policy. PHS Act). Some commenters were and under section 1302(b)(1) of the Response: Because § 156.111 particularly concerned about the impact PPACA. Second, we proposed at continues to define EHB based on a of this policy on markets beyond the paragraph (b)(2) to define requirements ‘‘benchmark plan’’ approach, we are Exchanges, particularly the large group regarding the scope of benefits that must continuing the policy of not requiring market and self-insured group health be provided by a State’s EHB- that a State’s EHB-benchmark plan plans. These plans are not required to benchmark plan. Specifically, we cover a specific service or services or provide coverage of EHB but must use proposed at paragraph (b)(2)(i) that the use particular providers. We are limiting a definition of EHB to determine which State’s EHB-benchmark plan must be the policy to the 2017 EHB-benchmark benefits apply to the prohibition of equal in scope of benefits to what is plans under Options 1 and 2 at annual and lifetime dollar limits and the provided under a typical employer plan. § 156.111(a)(1) and (2) to ensure that the annual limitation on cost sharing. These This proposed requirement reflects set of plans available for States to select commenters were generally concerned section 1302(b)(2) of the PPACA, which from under Option 1 and 2 are clearly about increased or shifting costs to requires the Secretary to ensure that the defined and reflect an EHB-benchmark consumers for benefits that are no scope of the EHB is equal to the scope plan that was used by another State. We longer EHB, particularly for vulnerable of benefits provided under a typical believe that this policy balances populations. Some commenters were employer plan, as determined by the providing flexibility to States to select concerned that since large group market Secretary. We proposed to define a from more options for their EHB- and self-insured group health plans typical employer plan as an employer benchmark plans while at the same time could use any State’s definition of EHB plan within a product (as these terms providing simplification of choice for purposes of the annual and lifetime are defined in § 144.103 of this within a defined set of plan options. dollar limit prohibition and the annual subchapter) with substantial enrollment Furthermore, this policy will not overly limitation on cost sharing, any State’s in the product of at least 5,000 enrollees limit State flexibility, as the third option definition could have the potential to sold in the small group or large group would permit a State to select from any impact plans nationwide. Other market, in one or more States, or a self- of the other 10 previous base-benchmark commenters wanted additional insured group health plan with plan options. While the 2017 EHB- information and evaluation of the substantial enrollment of at least 5,000 benchmark plans and the benchmark impact on how the change in definition enrollees in one or more States. We plans selected by States under would be implemented. sought comment on many parts of this § 156.111(a)(3) may not comply with all Response: As discussed in more detail definition, including: of the market reforms and consumer earlier in this section, the flexibility • Whether the definition of a typical protections applicable to plans offered established under § 156.111(a) is not employer plan should reflect in in the individual and small group intended to reduce benefits, but to allow substantial part a plan that would be markets, this is not a departure from the for more innovative benefits within the typical in the State in question; benchmarks that have been used to date. current benefit requirements. This • Whether an appropriate way to We reiterate the policy that non- means that a State’s EHB-benchmark measure typicality in that case would be grandfathered insurance plans in the plan may not have the exact same to provide that the typical employer individual and small group markets that benefits and limits as the typical plan be defined to also have at least 100 are required to comply with EHB must employer plan the State identifies under enrollees enrolled in that plan or not only provide benefits that are this policy, but this policy will still product in the applicable State; substantially equal to the EHB- result in the State’s EHB-benchmark • Whether typicality should be benchmark plan, but must also comply plan providing a scope of benefits that defined in other ways, including with all Federal requirements applicable is equal to, or greater than, the scope of whether it should be based upon the to plans offered in those markets, such benefits provided under a typical State’s 10 base-benchmark plan options as those benefit requirements at employer plan in accordance with for plan year 2017, supplemented as §§ 156.115, 156.122, 156.125, and § 156.111(b)(2)(i), satisfying the required to become the State’s EHB- 156.130(g). Secretary’s obligations at section benchmark plan under § 156.110; We also recognize that States have 1302(b) of the PPACA. Accordingly, we • Whether the definition of a typical different processes for selecting a do not expect that there will be a employer plan for this purpose should benchmark plan and as a result, the substantial change to the scope of the be limited to plans that already cover all State needs discretion in determining protections afforded under the annual 10 EHB categories;

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• Whether the proposed typical established under section 1302(b)(4)(C) particularly with regard to various employer plan definition should of the PPACA. populations. Some commenters exclude self-insured plans, since States At paragraph (c), we proposed that the appreciated the codification of certain may not have the ability to obtain the State must provide reasonable public EHB protections under section 1302(b) required information on those plans; notice and an opportunity for public of the PPACA into the regulation text, and comment on the State’s selection of an with some requesting the non- • Whether we should provide EHB-benchmark plan. We proposed that discrimination provisions from section additional guidance or requirements for this process would apply whenever a 1302(b) of the PPACA be included, too. the definition of a typical employer State changes its EHB-benchmark plan Some commenters wanted strong plan, such as requiring that the plan in accordance with proposed Federal enforcement of EHB selected as a typical employer plan be § 156.111(a). requirements, such as non- from a recent year after December 31, Lastly, we proposed at paragraph (d) discrimination. Some commenters 2013, requiring that the plan provide that a State must notify HHS of the believed that the standards were too minimum value, or requiring that the selection of a new EHB-benchmark plan vague or wanted additional guardrails plan selected as a typical employer plan by a date to be determined by HHS for on States’ EHB-benchmark plans. A few not be an indemnity plan or an account- each applicable plan year. We also commenters wanted certain based plan like a health reimbursement proposed that if the State does not make clarifications to § 156.111(b)(1), such as arrangement. a selection by the annual selection date, the inclusion of items and services or on Given that the proposed definition of the State’s EHB-benchmark plan for the requiring coverage of the 10 EHB a typical employer plan was a plan with applicable plan year would be that categories. enrollment of at least 5,000 enrollees in State’s EHB-benchmark plan applicable Response: In the proposed rule, we one or more States, we believed that the for the prior plan year. Taken together, did not propose to eliminate the EHB- State’s option to select another State’s these proposed requirements were benchmark plan standards under EHB-benchmark plan at proposed intended to align with statutory § 156.110. However, we recognize based § 156.111(a)(1) would automatically requirements. We affirmed that on comments that the applicability of meet the typical employer plan §§ 156.115, 156.122, and 156.125 would that section to benchmark plans selected requirement because each of the continue to apply to all plans subject to under the proposed § 156.111 was not as available options is an employer plan the EHB requirements. clear as it could have been. Therefore, that had substantial enrollment. We are finalizing the requirements for in response to commenters, we are We also solicited comment on a State’s EHB-benchmark plan with finalizing § 156.111(b) with certain whether actuaries could develop a certain amendments to: (1) Clarify that amendments that align with the statute standard of practice for a benefit the State’s EHB-benchmark must and that clarify the applicability of EHB- comparison calculation to determine provide coverage of items and services benchmark plan standards. We are that a plan is equal to the scope of for at least the 10 EHB categories; (2) amending § 156.111(b)(1) to more benefits provided under a typical add a codification of the currently explicitly state that the EHB-benchmark employer plan that could also apply to applicable requirement at § 156.110(d) plan must not only provide an determine that a State’s EHB-benchmark that the State’s EHB-benchmark plans appropriate balance of coverage of the must not include discriminatory benefit plan does not exceed the generosity of 10 statutory categories of EHB, but also designs that contravene the non- the most generous plan in accordance cover items and services in all 10 discrimination standards defined in with the third option under proposed categories. § 156.125; (3) modify the definition of a § 156.111(a)(3). We specifically sought We are also adding a new typical employer plan; (4) add a comment on our draft example of an § 156.111(b)(2)(v) to codify the requirement that the State must post a acceptable methodology for comparing continuing applicability of the currently notice of its opportunity for public applicable benchmark plan non- benefits of a State’s EHB-benchmark comment with associated information discrimination provisions under plan selection to the benefits of a typical on a relevant State website; (5) provide § 156.110(d) to the EHB-benchmark plan employer plan.68 that any State EHB-benchmark plan may selection options under § 156.111(a). In addition to meeting the typical be no more generous than the most Specifically, a State’s EHB-benchmark employer plan requirements, we generous among a set of comparison plan may not violate the non- proposed at paragraph (b)(2)(ii) that the plans, as described above; and (6) codify discrimination standards defined in State’s EHB-benchmark plan must also in regulation text the proposed standard § 156.125, which reflects the non- not have benefits unduly weighted in the preamble of the proposed rule discrimination provisions of section towards any of the categories of benefits that if a State’s benchmark plan 1302(b)(4) of the PPACA. at § 156.110(a) as established under selection does not meet the Comment: Many commenters opposed section 1302(b)(4)(A) of the PPACA. requirements of this section and section allowing States to annually update their Furthermore, we proposed at paragraph 1302 of the PPACA, the State’s EHB- EHB-benchmark plans. These (b)(2)(iii) that the State’s EHB- benchmark plan will be the State’s EHB- commenters had a variety of concerns benchmark plan must provide benefits benchmark plan applicable for the prior about annual updates to the benchmark for diverse segments of the population, year, as further described under the data plans, such as annual updating would including women, children, persons collection section below. To reflect the be administratively and financially with disabilities, and other groups as application of the generosity standard to burdensome to issuers, confusing for all three options under this regulation, consumers, lack predictability, or would 68 The Draft Example of an Acceptable Methodology for Comparing Benefits of a State’s we moved that provision from create instability that would not allow EHB-benchmark Plan Selection to Benefits of a § 156.111(a)(3) to § 156.111(b)(2), and issuers to assess the effectiveness of Typical Employer Plan As Proposed under the HHS have renumbered parts of previous changes before new changes Notice of Benefit and Payment Parameters for 2019 § 156.111(b)(2) for clarity. are implemented. Some commenters (CMS–9930–F) is available at https://www.cms.gov/ CCIIO/Resources/Regulations-and-Guidance/ Comment: Many commenters stated recommended limiting the changes to Downloads/Example-Acceptable-Methodology- that the definition of EHB provides every few years, with some supporting States-EHB.pdf. important protection to consumers, every 3 years, which aligns with the

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frequency with which the benchmark benefit designs, and are not directly or did not believe enrollment should be plans have previously been updated. regulated by States, and because it an indicator for typicality (as typicality Some commenters recommended would be difficult to obtain plan is about comparability and enrollment is timeframes for the State’s annual information for such plans. Some about size). submission process, such as requiring commenters stated that the lack of Response: We agree with commenters the EHB-benchmark plans to be specificity in the definition of a typical that the definition of EHB should finalized 18 months prior to the benefit employer plan could allow rare, outlier establish a minimum level of benefits. year, to help ensure that issuers have plans with extremely limited coverage In response to commenters’ concerns sufficient time to design products in to become the typical employer plan, or with the proposed definition of typical advance of the filing deadlines for the they requested that there be additional employer plan, we are finalizing two upcoming benefit year. requirements on the typical employer sets of typical employer plans from Response: As discussed in the plan to prevent outlier plans from being which a State may choose for purposes proposed rule, we recognize the burden the typical employer plan. Commenters of ensuring a minimum scope of on States and issuers of making changes were concerned that the definition benefits for the State’s EHB-benchmark to a State’s EHB-benchmark plan. could jeopardize adequate coverage of plan, which establishes the State’s EHB Specifically, we anticipated most States the 10 EHB categories, lowering the definition. would need to invest resources to threshold for minimum coverage, or First, we are finalizing that the typical analyze the three new EHB-benchmark allowing insurers to offer plans with employer plan may be one of the plan selection options to make an less generous benefits, weakening the selecting State’s 10 base-benchmark informed selection, even if a State PPACA protections for individuals with plan options established at § 156.100 defaults. We also anticipated that disabilities and complex medical needs. from which the State could select for the issuers offering plans that provide EHB Some commenters were particularly 2017 plan year. This definition, which would incur additional administrative concerned that the policy in the allows the selecting State to continue to costs associated with designing plans proposed rule generally focused on select from its previous options, will compliant with the State’s newly using the definition of EHB to create a allow a selecting State to modify its selected EHB-benchmark plan.69 ceiling for the scope of benefits. They previous base-benchmark plan options Because of the level of effort needed by expressed concern that the generosity to innovate those benefits to better meet the State and its issuers to make changes standard limits the scope of benefits to the needs of consumers in its market. to a State’s EHB-benchmark plan, we certain previous benchmark plan Second, we are finalizing that a believe that in only very limited cases options, instead of providing the floor typical employer plan also may be the will a State choose to make EHB- for the scope of benefits, as they stated largest health insurance plan by benchmark plan changes on an annual PPACA intended the definition of EHB enrollment in any of the five largest basis. We believe that if a State does to be. These commenters were large group health insurance products decide to make changes annually, there concerned that decreased benefits by enrollment in the selecting State, as may be a specific reason for needing an would result in high costs for product and plan are defined at annual change such as for a medical consumers to access those services. § 144.103, provided that: (1) The innovation where such benefits would Some commenters wanted more product has at least 10 percent of the outweigh any potential for consumer specificity in the definition of typical total enrollment of the five largest large confusion. We also do not believe that employer plan, such as wanting the plan group health insurance products by such changes would rise to the level of to be specific to the State to ensure enrollment in the selecting State; (2) the creating market instability. The purpose compatibility in the State or meet State plan provides minimum value, as of this policy is to allow for State requirements, be required to cover all 10 defined under § 156.145; (3) the benefits flexibility in selecting an EHB- EHB categories or minimum benefit are not excepted benefits, as established benchmark plan, and we believe it is standards, be from a recent plan year, under § 146.145(b) and § 148.220; and important for States to retain the constitute MEC, provide minimum (4) the benefits in the plan are from a flexibility to choose when the State value (or some other actuarial value plan year beginning after December 31, wants to make changes to its EHB- standard), not be an account-based plan, 2013. benchmark plan. Therefore, we are not be a preventive-services-only plan For purposes of this definition, we are finalizing the policy as proposed. or an excepted benefit plan or not be an applying the Federal definitions of plan As described in the next section, we indemnity plan. Some commenters and product at § 144.103.70 Under these are finalizing the 2020 deadline for supported the definition of a typical definitions, the product comprises all submission of a State’s EHB-benchmark employer plan for its flexibility or plans offered with the same covered plan under § 156.111(a). For plan years supported aspects of the proposed benefits and as a result, each plan after 2020, we intend to announce the definition. Another commenter noted within a product must have the same annual EHB-benchmark plan selection that if a State-specific enrollment benefit package. To ensure that these deadline to States in the annual notice requirement is added, current EHB- plans are typical within the selecting of benefits and payment parameters. benchmark plans under the first option State, the determination of each Because we expect that the number of may not automatically meet the product’s enrollment numbers is based submissions for each plan year will definition. on enrollment in the selecting State. vary, we will not be providing a specific Commenters recommended different date as to when the State’s EHB- enrollment thresholds for the typical 70 Section 144.103 defines ‘‘product’’ as ‘‘a benchmark plans for a given plan year employer plan, with some commenters discrete package of health insurance coverage benefits that are offered using a particular product will be finalized. noting that substantial enrollment varies network type (such as health maintenance Comment: Many commenters opposed by State or the lack of justification for organization, preferred provider organization, allowing the definition of typical the 5,000 enrollee threshold. Other exclusive provider organization, point of service, or employer plan to include self-insured commenters believed that the proposed indemnity) within a service area’’ and a plan as ‘‘with respect to a product, the pairing of the health plans, as these plans can have unique policy disregarded the concept of insurance coverage benefits under the product with typicality as being the scope of coverage a particular cost-sharing structure, provider 69 82 FR at 51131. typically seen in employer-based plans network, and service area.’’

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Also, to ensure that none of these requirements under § 156.145. Under plan, respond to commenters’ concerns products are outliers within the State, § 156.145, an employer-sponsored plan regarding the risk that the definition of only plans from products that have at provides minimum value only if the typical employer plan would include least 10 percent of the total enrollment percentage of the total allowed costs of atypical plans and ensure that the of the five largest large group health benefits provided under the plan is requirement for the EHB-benchmark insurance products can be selected. For greater than or equal to 60 percent, and plans’ scope of benefits to be equal to example, if a selecting State’s three the benefits under the plan must that of a typical employer plan can largest large group health insurance include substantial coverage of inpatient account for benefits within each EHB products under the second definition at hospital services and physician services, category at § 156.110(a). § 156.111(b)(2)(ii) have 92 percent of the characteristics that we believe are Comment: Some commenters believed enrollment in the selecting State among reflective of typical employer plans. For that the statute requires that the scope the five largest large group health example, by requiring the typical of benefits for the typical employer plan insurance products in the State, the employer plan meet MV, outlier plans, be informed by the Department of Labor fourth and fifth largest large group such as preventive-services-only plans, report 71 required under section health insurance products in the which do not provide substantial 1302(b)(2)(A) of PPACA. These selecting State will not have at least 10 coverage of inpatient hospital and commenters did not believe that the percent of the enrollment and therefore, physician services in accordance with proposed typical employer plan will not be an option under the second the MV requirement, could not satisfy definition was informed by the 2011 prong of the typical employer plan the second definition of typical DOL report and were concerned that definition. The use of enrollment size in employer plan. defining the typical employer plan defining the typical employer plan To further respond to comments using enrollment instead of typicality of aligns with the previous policy where recommending that we ensure that benefits allows skimpier benefits, which the base-benchmark plan options were outlier plans are excluded from the would have a detrimental effect on the also determined based on the definition of typical employer plan, we most vulnerable enrollees in a way that enrollment in those markets. are finalizing as part of the second contravenes the PPACA requirement Furthermore, by using the largest prong of the definition a requirement and implicates the Americans with products by enrollment in the selecting that the plan’s benefits are not excepted Disabilities Act. Some commenters were State, rather than on a specified benefits, as defined under § 146.145(b), particularly concerned about the impact enrollment size, we ensure that any and § 148.220. For example, a worker’s of the proposed typical employer plan variation in population size by the compensation plan would not meet the definition under the third option and selecting State is taken into account. We second prong of the definition of a some commenters expressed concern believe this second prong of the typical employer plan. This requirement about the potential scope of coverage definition provides States with specifically ensures that the typical under plans that meet the proposed important additional flexibility, as it employer plan is a major medical plan. definition. Some commenters expressed expands the comparison options Lastly, we are requiring that the benefits concern about coverage of benefits for available to States when comparing in the plan are from a plan year specific groups, such as those with their selected EHB-benchmark plan to a beginning after December 31, 2013. This opioid use disorders. typical employer plan, while requirement is consistent with the Response: As required by section simultaneously ensuring the statutory options under the first prong of the 1302(b)(2)(A) of the PPACA, the requirement that the definition of EHB typical employer plan definition, which Department of Labor conducted a survey be equal in scope to a typical employer references plans originally offered in of employer-sponsored coverage and plan is met. 2014. published a report on the survey on We agree with commenters that self- In applying the typical employer plan April 15, 2011. In determining what insured plans have a significantly definition, we recognize that States may constitutes a typical employer plan, greater likelihood of being plans with find that the plans that meet the HHS reviewed and considered the atypical benefit designs. Therefore, this definition of a typical employer plan findings of this survey. As discussed in definition for typical employer plan may not provide coverage for items and more detail earlier in this section, the services within each EHB category at does not include self-insured plans, flexibility established under § 156.110(a). Therefore, we are including health reimbursement § 156.111(a) is not intended to reduce finalizing that the State’s EHB- arrangements. We also recognize that benefits, but to allow for more benchmark plan must provide a scope of States would have challenges obtaining innovative benefits within the current benefits that is equal to, or greater than, information about these other types of benefit requirements. Similarly, with to the extent any supplementation is plans, especially at the level of detail regard to comparing the scope of required to provide coverage within needed for the plan to be used as a benefits of an EHB-benchmark plan to a comparison to the State’s EHB- each EHB category at § 156.110(a), the typical employer plan, we note that the benchmark plan. To limit the burden on scope of benefits provided under a scope of benefits refers to the overall States to determine which plans in the typical employer plan. The purpose of extent of benefits covered, not to the State would be included in the second this approach is to permit States’ EHB- inclusion of any particular benefits. A set of plans, we are limiting the second benchmark plans’ scope of benefits not State’s EHB-benchmark plan is not set under the definition of typical to be equal to the benefits under the required to cover a particular benefit employer plan to large group market typical employer plan definition, only because that benefit is part of the typical health insurance plans and products. by exceeding the scope of benefits In response to commenters who provided by the typical employer plan, employer plan the State uses to assess recommended that the typical employer and only if necessary to ensure that all the scope of benefits in its EHB- plan be required to provide minimum EHB categories of benefits are being benchmark plan. Rather, the particular value (MV), we are also finalizing as covered. We believe that these 71 Selected Medical Benefits: A Report from the part of the second prong of the requirements, when taken together, Department of Labor to the Department of Health definition of the typical employer plan ensure outlier plans are excluded from and Human Services. April 15, 2011. https:// that the plan must meet MV the definition of a typical employer www.bls.gov/ncs/ebs/sp/selmedbensreport.pdf.

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benefits and limitations in a State’s previously to provide public notice and (3), that the State’s documentation must EHB-benchmark plan are established an opportunity for public comment on include an actuarial certification and an through one of the options defined in their EHB-benchmark plan selections. associated actuarial report from an §§ 156.100, 156.110 or 156.111 and the Therefore, in an effort to retain State actuary, who is a member of the resulting EHB-benchmark plan provides flexibility under this requirement, with American Academy of Actuaries, in a scope of benefits that is equal to, or one exception, we are finalizing a policy accordance with generally accepted greater than the scope of benefits that under which States must provide actuarial principles and methodologies, typical employer plan, as explained reasonable public notice and affirming that the State’s EHB- earlier in this preamble. opportunity for public comment, but benchmark plan is equal in scope of We encourage States to consider, as will look to States to reasonably benefits provided under a typical they select their EHB-benchmark plans, interpret that requirement. In response employer plan. We proposed that if the the potential impact on vulnerable to comments, we are finalizing a State is selecting its EHB-benchmark populations, and the need to educate requirement that the State, regardless of plan using § 156.111(a)(3), which allows consumers on benefit design changes. the public comment process it uses to the State considerable flexibility to Specifically, as States work to address select its EHB-benchmark plan, must otherwise select a set of benefits that the opioid crisis, we urge States to post a notice on a relevant State website would become its EHB-benchmark plan, consider whether and how selecting a regarding the opportunity for public that the actuarial certification and new EHB-benchmark plan could help comment with associated information. associated report would also affirm that address the crisis in their State. For States that do not have a public the new EHB-benchmark plan does not Comment: Commenters generally notice and comment process for these exceed the generosity of the most supported requiring States to provide purposes, these States should consider generous among the set of comparison public notice and an opportunity for using a similar process for public plans specified in paragraph (a)(3). For public comment on its selection of an comment to the one established at the actuarial certification, we proposed EHB-benchmark plan, with some § 155.1312(a)–(c). We also remind States that these documents, in accordance commenters supporting State flexibility that any public participation processes with generally accepted actuarial to determine the process. Most must continue to comply with principles and methodologies, would commenters, on the other hand, wanted applicable Federal civil rights laws, include complying with all applicable minimum or standardized requirements including those that require covered Actuarial Standards of Practice (ASOP) for the public comment process, such as entities to provide meaningful access for (including but not limited to ASOP 41 requiring the solicitation of input from individuals with limited English on actuarial communications). We also certain groups, a public hearing, a proficiency, and those that require sought comment on a draft methodology comment period of 30 days or 60 days, effective communications for for comparing benefits of a State’s EHB- the posting of usable and individuals with disabilities, including benchmark plan selection to the benefits understandable data, analysis and plan web accessibility requirements. The of a typical employer plan for the documents (such as the documentation public notice process at § 156.111(c) actuarial certification and associated to be submitted to HHS under applies whenever a State changes its actuarial report 72 and on whether the § 156.111(e)), posting of any changes, a EHB-benchmark plan in accordance draft methodology should be the requirement that the State submit with § 156.111(a). required approach for the State’s documentation on its public hearing iii. Data Collection for State’s EHB- actuarial certification and associated process to HHS, or some combination of Benchmark Plans for 2020 Plan Year actuarial report. these standards. These commenters and Later (§ 156.111(e)) Third, we proposed at paragraph typically wanted a transparent process We proposed data collection (e)(3) that the State would be required to ensure meaningful and equal to submit an EHB-benchmark plan participation of consumers, or wanted to requirements at § 156.111(e) for a State that opts to select a new EHB- document that reflects the benefits and reduce the burden of having a different limitations in the benchmark plan, process for each State. One commenter benchmark plan under § 156.111(a) in any given year, beginning with the 2019 including the medical management wanted the regulation to at least requirements, a schedule of benefits reference the State’s applicable public plan year. We proposed that a State and, if the State is selecting its EHB- comment period under the State’s must submit documents in a format and benchmark plan using the option in administrative procedure act or manner specified by HHS by a date paragraph (a)(3), a formulary drug list in department of insurance rules while determined by HHS and proposed four a format and manner specified by HHS another was concerned that the rule areas of documentation. First, at similar to current § 156.120. For a State assumes that a State has in place a paragraph (e)(1), we proposed to require that chooses an EHB-benchmark plan reasonable public comment process. documentation that would confirm that under proposed § 156.111(a)(1), the Some commenters supported requiring the State’s EHB-benchmark plan State may submit the plan document the State to post public notice while complies with the requirements under from the other State’s EHB-benchmark other comments wanted a process to proposed § 156.111(a), (b) and (c), identify inadequacies or appeal a State’s which includes the requirement that the plan used for the 2017 plan year to decision. 10 EHB categories of benefits are fulfill this proposed requirement. For a Response: We agree with commenters covered under the State’s EHB- State that selects an EHB-benchmark that the State public notice and benchmark plan. This documentation plan under proposed § 156.111(a)(2), the comment period is important for would also include information on 72 The Draft Example of an Acceptable transparency to allow consumers to which selection option under proposed Methodology for Comparing Benefits of a State’s provide feedback on the States’ § 156.111(a) the State is using, including EHB-benchmark Plan Selection to Benefits of a proposed changes to their EHB- whether the State is using another Typical Employer Plan As Proposed under the HHS benchmark plans. However, we believe State’s EHB-benchmark plan. Notice of Benefit and Payment Parameters for 2019 (CMS–9930–F) is available on CCIIO’s Regulation that States have varying processes for Second, in paragraph (e)(2), we and Guidance web page at https://www.cms.gov/ soliciting and receiving comments and proposed, for a State selecting an EHB- cciio/resources/regulations-and-guidance/ may have used varying processes benchmark plan under § 156.111(a)(2) or index.html.

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State could create a combined plan (CCIIO) website. We also considered State’s EHB-benchmark plan drug list document by assembling parts of the posting the State’s EHB-benchmark plan will be posted in the category and class plan documents from the other State’s confirmations proposed at count format in the EHB summary chart or States’ benchmark plan documents. § 156.111(e)(1). as the current drug counts are currently We acknowledged that States may need We proposed that in order for a State’s posted.76 to make conforming edits in the other selection of a new EHB-benchmark plan Because EHB-benchmark plan States’ plan documents to align from the proposed options to be benefits are based on plans that were language and terminology. For a State accepted, the State’s new EHB- sold in 2014, some of the benchmark that chooses the option proposed at benchmark plan must comply with the plan documents may not comply with § 156.111(a)(3), the State may need to associated EHB regulatory and statutory current Federal requirements. For this develop a plan document. Additionally, requirements, including those under reason, the State confirmations require under proposed § 156.111(e)(3), if the this final rule. If a State’s EHB- the State to confirm that its EHB- State is selecting its EHB-benchmark benchmark plan selection does not meet benchmark plan meets the requirements plan using the option in § 156.111(a)(3), these regulatory and statutory to be an EHB-benchmark plan. Since we proposed that the State must also requirements, the State’s current EHB- States are typically the primary enforcer include a formulary drug list for the benchmark plan would continue to of EHB policy, States may take varying State’s EHB-benchmark plan in a format apply. We solicited comments on the approaches to the level of details and manner specified by HHS. We also proposed processes and deadlines for included in the EHB Summary Chart, as proposed that for a benefit, such as the the 2019 and 2020 plan years.74 We also we believe the manner in which the pediatric dental benefit, that is defined solicited comments on the proposed State displays the EHB-benchmark plan by another program under the State’s data collection and associated in the EHB Summary Chart may be EHB-benchmark plan, the State may documents and whether other reflective of the State’s EHB submit a separate document that reflects specifications for these documents are enforcement strategies. the benefits and limitations, including needed. We are finalizing the provisions Furthermore, we also recognize that the medical management requirements at § 156.111(e) with an amendment to the States’ 2017 EHB-benchmark plans and a schedule of benefits comparable § 156.111(e)(2) to reflect the changes to may need conforming edits to comply to how States that defined their dental § 156.111(b)(2)(i) and (ii) described with other laws and regulations, and to coverage using their State’s CHIP above. We are finalizing that the policy account for any benefits considered EHB programs have done previously. will begin applying for the 2020 plan under § 155.170. For these reasons, we Otherwise, regardless of which option year. clarified in the proposed rule that the State is using to select a new EHB- Comment: Commenters generally benefits and limits described in the benchmark plan, the State would be supported transparency in EHB- available benchmark plan documents on our website may not be fully applicable expected to submit one comprehensive benchmark plan documents and making due to other laws and regulations. For plan document for the entire State’s these documents publicly available. instance, under section 2711 of the PHS EHB-benchmark plan selection. Some commenters noted concerns about Lastly, we proposed under paragraph the completeness and accuracy of Act, as added by the PPACA, issuers (e)(4) to require the State to submit current EHB-benchmark plan may not impose lifetime or annual documentation specified by HHS, which documents and the inconsistent level of dollar limits on EHBs. When lifetime or is necessary to operationalize the State’s detail among EHB summary charts, annual dollar limits are specified in EHB-benchmark plan. This encouraging accuracy in plan available EHB-benchmark plan documentation would be used to information to limit confusion. documents, States would have removed provide public resources on a State’s Response: Section 156.111(e) is the dollar limits or converted them to EHB-benchmark plan and support designed to ensure that the State’s EHB- non-dollar limits when interpreting and related templates and tools. We benchmark plan meets the requirements applying EHB policy. HHS recognizes proposed that this documentation at § 156.111(b), (c), and (d) and to most States as the primary enforcers of would include a complete and accurate ensure that the State’s EHB-benchmark EHB policy. Thus, when a State would EHB summary chart that reflects the plan has a clearly defined set of covered use an EHB-benchmark plan that State’s EHB-benchmark plan and aligns benefits. In an effort to support originated in another State under any with the documentation that we transparency, we will post all proposals under § 156.111, we would 75 currently make publicly available on a documents that a State submits generally defer to the selecting State’s State’s EHB-benchmark plan. For States pertaining to its EHB-benchmark plan implementation of the benefits and that choose § 156.111(a)(1) or (a)(2) selection on CCIIO’s website with the limits consistent with otherwise where the State is developing its exception of the drug list. These applicable law, even when such benchmark plan based on another documents will include the State’s interpretation differs from the State’s EHB-benchmark plan, the State confirmations (§ 156.111(e)(1)), any originating State’s interpretation. Where could develop this document utilizing actuarial certification and associated possible, States should provide clarity information from the EHB summary actuarial report (§ 156.111(e)(2)), the on benefits and limits in the documents chart that is currently publicly plan documents (§ 156.111(e)(3)), and collected under § 156.111(e) or note available.73 the documents necessary to differences in the States’ EHB summary We proposed that HHS would post operationalize the State’s EHB- chart. the State’s EHB summary document and benchmark plan (§ 156.111(e)(4)). The Lastly, we are codifying in regulation the State’s EHB-benchmark plan text at § 156.111(d)(1) a proposed document on the Center for Consumer 74 For the 2019 plan year, HHS would post States’ standard that we discussed in the EHB-benchmark plan documents after the proposed Information and Insurance Oversight preamble of the proposed rule, under State submission deadline, which would likely be which the State’s new EHB-benchmark in April 2018. 73 All States’ current benchmark plan documents 75 CMS’s PRA website is available at https:// plan must comply with the regulatory are posted on CCIIO’s website at https:// www.cms.gov/Regulations-and-Guidance/ www.cms.gov/CCIIO/Resources/Data-Resources/ Legislation/PaperworkReductionActof1995/PRA- 76 https://www.cms.gov/CCIIO/Resources/Data- ehb.html. Listing.html. Resources/ehb.html.

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and statutory requirements, including The purpose of the policy being the determination of the typical those under this final rule, in order for finalized at § 156.111 is to strike a employer plan, and further explained HHS to accept a State’s selection of a balance between providing flexibility to how an actuary could use a typical new EHB-benchmark plan from the allow States’ additional options to select employer plan or a comparison plan for options under § 156.111(a). If a State’s their EHB-benchmark plans and this certification and associated report. EHB-benchmark plan selection does not ensuring that States’ EHB-benchmark Second, we are finalizing the meet these regulatory and statutory plans meet the associated statutory definition of a typical employer plan to requirements, the State’s current EHB- requirements. To that end, the actuarial establish the minimum level of benefits benchmark plan would continue to certification and associated actuarial for the State’s EHB-benchmark plan and apply. report are intended to ensure that the the generosity standard to establish the Comment: Some commenters on the scope of EHB is equal in scope to the maximum level of benefits for a State’s Draft Example of an Acceptable benefits provided under a typical EHB-benchmark plan selection. By tying Methodology for Comparing Benefits of employer plan, and to provide the the maximum level of benefits, in part, a State’s EHB-benchmark Plan Selection information to support the certification to certain previous States’ EHB- to Benefits of a Typical Employer Plan from the Chief Actuary of CMS for the benchmark plan options, the new State As Proposed under the HHS Notice of Secretary to submit along with a report EHB-benchmark plan selections are tied Benefit and Payment Parameters for to Congress, consistent with section to generosity of the current EHB- 2019 (CMS–9930–F) did not support 1302(b)(2)(B) of the PPACA. Section benchmark plans in the States, which is parts of the proposed methodological 1302(b)(2)(B) of the PPACA requires that not what a 102 percent upper bound approach. Comments generally did not the Chief Actuary of CMS certify that limit would provide. For these reasons, support the use of small group index the scope of EHB as defined by the we believe that creating an additional rates or wanted an upper-bound limit of Secretary is equal to the scope of upper-bound limit under the typical 98 percent to 102 percent for the benefits provided under a typical employer plan in the example category comparison, with some employer plan. Through this rule, the methodology is not necessary, would be commenters, noting the difficulty in Secretary is determining that the duplicative, and would be difficult to conducting this type of calculation or actuarial certification and associated implement with the generosity standard recommending additional input or more actuarial report at § 156.111(e)(2) at § 156.111(b)(2)(ii). detail. Others wanted to require ensures any EHB-benchmark plan Lastly, to support the use of more actuarial data from the States to justify selection is meeting the requirements at appropriate data for the actuarial adoption of a benchmark plan that section 1302(b)(2)(A) of PPACA; certification and associated actuarial varies significantly from their current therefore, we are finalizing these report, we removed the use of small benchmarks in any category. Comments requirements. group index rates from the calculation on the actuarial certification and This includes the requirement that the of the expected value. Instead, we associated actuarial report requirements actuarial certification and associated provide other examples of acceptable varied on which EHB-benchmark actuarial report be prepared in data that an actuary may use, including selection options it should apply to. accordance with generally accepted data acquired from issuers in the State Response: To account for the actuarial principles and methodologies. for a recent plan year, and weighted the application of the typical employer plan This includes all applicable ASOPs. For services and benefits provided in each definition at § 156.111(b)(2)(i) and the example, ASOP 41 contains disclosure EHB category. We believe that the generosity standard at § 156.111(b)(2)(ii) requirements, including those that changes to the methodology will help to all selection options, we are finalizing apply to the disclosure of information inform actuaries on how to approach the § 156.111(e)(2) with certain changes. on the methods and assumptions being actuarial certification and associated Specifically, we are finalizing the used and ASOP 50 contains information report at § 156.111(e)(2). requirement that States provide an on determining MV and AV. In Comment: Commenters generally actuarial certification and an associated accordance with ASOP 41, we would opposed implementing the new EHB- report from an actuary from the expect that the actuarial report is based benchmark plan options for the 2019 American Academy of Actuaries, in on a data analysis that is reflective of an benefit year. Some of these commenters accordance with generally accepted appropriate population. were concerned about operational and actuarial principles and methodologies, State actuaries may need flexibility in administrative feasibility and burden to that affirms: (1) That the State’s EHB- developing the actuarial certification implement an EHB change for 2019, as benchmark plan provides a scope of and report depending on the type of well as the lack of adequate time to benefits that is equal to, or greater than, changes that the State is interested in design products and meet 2019 rate and to the extent any supplementation is making to its EHB-benchmark plan and form filing deadlines. Other commenters required to provide coverage within depending on the typical employer plan were concerned about the ability for each EHB category at § 156.110(a), the that the State is using for the States and issuers to evaluate options, or scope of benefits provided under a certification and report. For these the impact of the policy leading to typical employer plan as defined at reasons, we are finalizing an example market instability, increased costs, or § 156.111(b)(2)(i); and (2) the State’s methodology with several changes.77 consumer confusion. Some commenters EHB-benchmark plan does not exceed First, to provide clarification for noted that the goal of market stability the generosity of the most generous actuaries, we expanded the was more important than the goal of among the set of comparison plans at methodology to address the providing States with added flexibility. § 156.111(b)(2)(ii)(A) and (B). States will determination of the plan generosity Another commenter was concerned be required to submit an actuarial under § 156.111(b)(2)(ii) in parallel to about the potential for data errors due certification and an associated report to short timeframes. under § 156.111(e)(2) to affirm that both 77 Example of an Acceptable Methodology for Commenters generally supported of the standards at § 156.111(b)(2)(i) and Comparing Benefits of a State’s EHB-benchmark making EHB-benchmark plan changes Plan Selection in Accordance with 45 CFR § 156.111(b)(2)(ii) are met, regardless of 156.111(b)(2)(i) and (ii) is available at https:// for the 2020 plan year at the earliest, which selection option under www.cms.gov/cciio/resources/regulations-and- with some noting that the 2020 § 156.111(a) they use. guidance/index.html. timelines aligns with previous

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benchmark plan timelines. Certain paragraph (b)(1)(ii) to allow States to We believe States are best positioned commenters wanted additional analysis permit issuers to substitute benefits to weigh the benefits of innovative plan or information before implementing any within the same EHB category and design with any effects on State risk change. Other commenters wanted to between EHB categories, as long as the pools, and therefore, will only permit ensure that States provide outreach to substituted benefit is actuarially substitution between EHB categories in consumers on the EHB-benchmark plan equivalent to the benefit being replaced States that have notified HHS that changes. A commenter wanted to and is not a prescription drug benefit. substitution between EHB categories is understand how guaranteed The plan with substitutions would still permitted by the State. Further, because renewability might affect changes to be required to provide benefits that are States are generally the primary plans being made to reflect changes substantially equal to the EHB- enforcers of EHB requirements, from a new State EHB-benchmark plan benchmark plan, to provide an including the prohibition on selection. appropriate balance among the EHB discrimination at § 156.125, we believe Response: We acknowledge the categories such that benefits are not States can best assure that plan designs operational and administrative unduly weighted towards any category, meet the needs of their State residents. difficulties for States, issuers and and to provide benefits for diverse We anticipate that States will notify consumers with implementing a segments of the population. It is HHS of their decision, if any, to allow changing benefit design under the generally the State’s responsibility to substitution between EHB categories timeframes for the 2019 benefit year, assess that plans required to provide through the same means States use to and believe that a 2020 implementation EHB adhere to these requirements. notify HHS of an updated EHB- date would provide these stakeholders We noted that nothing in this benchmark plan selection under with additional time to ensure a smooth proposal would prohibit plans required § 156.111. If a State wishes to permit implementation of any benefit design to provide EHB from imposing non- between-category substitution, it will changes. For these reasons, we will dollar limits, unless otherwise notify HHS, and that notification will be 80 make § 156.111 effective for the 2020 prohibited by Federal law. In addition, in effect unless and until the State plan year. We are also finalizing the we noted that we would continue to notifies HHS otherwise. States that deadline for State submission of its defer to States, which have the option permit between-category substitution EHB-benchmark plan as July 2, 2018, for to set criteria for benefit substitution, to should work with their issuers to ensure 78 the 2020 plan year. This deadline enforce a stricter standard on benefit they are aware of this option. We plan aligns with the timing of HHS’s substitution, or to prohibit it altogether to post on CCIIO’s website a list of previous updates to the benchmark consistent with paragraph (b) of this States that allow substitution between plans. section. We sought comment on EHB categories. As for guaranteed renewability, under examples of substitution that issuers some circumstances, issuers may be would be interested in pursuing. Comment: The majority of permitted to change their products to We are finalizing the proposal with commenters to this proposal expressed reflect new requirements for providing amendments to clarify when issuers concerns about this proposed policy, EHB as uniform modifications of their may substitute benefits and States’ roles and many commenters to this proposal products. Otherwise, if the changes to in permitting or prohibiting raised concerns about this policy’s products are deemed to result in the substitution. Specifically, we are potential impact on the risk pool. removal of products from the market, finalizing the change to allow issuers to Specifically, commenters were issuers would be required to meet the substitute benefits between EHB concerned that the proposal would product discontinuance requirements categories, beginning with plan year permit issuers to design products that under § 147.106, which generally 2020, if the State in which the plan will are intended to be unattractive to require at least 90 days advanced notice be offered permits such substitution and higher-cost populations to discourage to the enrollees of the discontinuance. notifies HHS of its decision to allow enrollment from these populations. Some of these commenters were c. Provision of EHB (§ 156.115) substitution between categories. We also add a clarification at § 156.115(b)(3)(i) concerned about resulting adverse Currently, to provide EHB, plans are that plans with substitutions are not selection, and were concerned that required to provide benefits that are relieved of their requirements under finalizing the policy could ultimately substantially equal to the EHB- § 156.115(a), including the requirement interfere with the stability of the benchmark plan. However, an issuer of to cover preventive health services, as individual and small group market risk a plan offering EHB may substitute required under 45 CFR part 147. pools. Several commenters were benefits within categories, if allowed by We are finalizing 2020 as the first concerned that the requirement that the State, provided that the benefits are plan year in which issuers, with the substituted benefits be actuarially actuarially equivalent to the benefit that permission of the State, may substitute equivalent does not address this is being replaced. Substitutions of benefits between categories to align with concern, because actuarial equivalence prescription drug benefits are not the first year for which States may is based on a standard population and 79 permitted. In the EHB Rule, we update their EHB-benchmark plans cannot take into account the potential finalized a policy at § 156.115(b)(1) under § 156.111. effects of adverse selection. Commenters under which substitution may not occur were concerned that this type of between different benefit categories. 80 See Frequently Asked Questions on Essential ‘‘gaming’’ to deter enrollment from In an effort to promote greater Health Benefits Bulletin (February 17, 2012), Q9, members of certain groups could flexibility, consumer choice, and plan available at https://www.cms.gov/CCIIO/Resources/ undermine State risk adjustment innovation through coverage and plan Files/Downloads/ehb-faq-508.pdf and the EHB rule. programs. Additionally, many design options, we proposed modifying As finalized in the EHB Rule, issuers of QHPs were permitted to make actuarially equivalent commenters requested that if we chose substitutions within statutory categories under to finalize this proposal, we publish 78 We proposed July 1, 2018, but recognize that § 156.115(b)(1)(ii). Therefore, and as further additional guidance clarifying how July 1, 2018 is a Sunday, so we are finalizing the explained in the EHB FAQ, plans are permitted to 2020 deadline as July 2, 2018. impose non-dollar limits, consistent with other issuers could utilize substitution 79 See § 156.115(b)(1)(iii), as established in the guidance, that are at least actuarially equivalent to between EHB categories without EHB Rule. the annual dollar limits. violating antidiscrimination

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requirements. Some commenters stated services in that EHB category. However, offered has notified HHS that that they could not conceive of a this equivalence of dollar amounts and substitution between EHB categories is situation in which cross-category proportionality does not apply when permitted in the State. We recognize substitution would be useful, and comparing between different categories, that State legislative cycles may make it notwithstanding our request for such making a comparison more difficult. challenging for States to adopt examples, we did not receive any.81 Relatedly, another commenter noted legislative requirements allowing or Response: We seek to promote issuer that the lack of uniformity among plans prohibiting substitution between flexibility and consumer choice with this policy could produce could categories in time for plan year 2020. By this proposal, but recognize that there increase administrative burden on finalizing this notification approach, we are potential trade-offs with regard to issuers, as well as States, by making it seek to make it easier for States to the risk pool and risk adjustment more difficult for issuers to conform immediately exercise the flexibility programs. We believe that States are plans to filing templates related to QHP provided in this rule. more attuned to the needs of their certification. We appreciate the comment about issuers and consumers than HHS and Due to concerns including additional increased burden on issuers. Because can better assess the proper balance burden on State regulators, commenters issuers are already familiar with between flexibility in plan benefits and also requested that if we were to finalize substituting benefits within benefit risk pool stability. Because issuers are this proposal, States be permitted to bar categories, we do not believe that required under the rule to provide substitution between EHB categories. broadening the policy to allow benefit benefits that are substantially equal to Almost all commenters asked that we substitution between benefit categories the EHB-benchmark plan, provide an consider the increased burden that will create additional burden for issuers. appropriate balance among the EHB consumers would face when comparing However, if it does, issuers have the categories such that benefits are not plans due to plan complexity related to discretion to avoid additional burden by unduly weighted towards any category, a possible lack of uniformity across EHB choosing not to substitute benefits and provide benefits for diverse benefit categories and across available between EHB categories, even if allowed segments of the population, we expect plans. In particular, commenters noted by their State. If a State chooses, we that effects on the risk pool will be that it would become more difficult for believe issuers should be permitted to limited and can be appropriately consumers in States that chose to permit decide whether the additional flexibility managed through State regulation. this option to make meaningful in plan design provided by substitution Because States are generally the primary comparisons between plans due to the between categories is worth any enforcers of the prohibition on difficulty in determining whether additional required effort. We also discrimination in the provision of EHB, benefits had been substituted between encourage States to consider the impact we defer to States to provide guidance EHB categories and, if so, whether the on issuers as they weigh whether to to issuers on how to utilize substitution resulting coverage package adequately allow substitution between categories. while meeting anti-discrimination met their needs. One commenter added We recognize that consumers may requirements. that these difficulties could also face some additional burden in Comment: While commenters undermine the value of the market comparing plans when States allow generally supported efforts to provide signals that consumers’ choices between-benefit substitution and one or States and issuers with additional currently generate to issuers and other more issuers in the State utilize such flexibility, a majority of commenters key stakeholders. substitution. However, we believe expressed strong concerns that this Finally, in addition to concerns about permitting substitution between specific policy would put undue burden consumer burden due to increased plan categories could offer significant benefit on multiple stakeholders due to complexity, many commenters also to consumers in the form of more increased plan design complexity. For objected to this proposal due to the choices, particularly those actively example, many commenters wrote that possibility that it could undermine engaged in shopping for health plans. regulators in States that choose to coverage for services that are crucial for Some consumers are likely to find plans permit substitution between EHB vulnerable consumers and prevent that better meet their needs under this benefit categories would face additional coverage of chronic conditions. change, because issuers are likely to challenges due to the difficulty of Response: We agree that permitting make substitutions that fulfill consumer determining whether plans that substitution between EHB categories demands. Further, we believe States are substituted benefits between EHB could make it more difficult for State best positioned to weigh the benefits of offered an adequate distribution of regulators to review plans. However, we innovative plan design with the benefits across all EHB categories. One believe States should have the flexibility potential for increased burden for commenter added that evaluating plans to determine whether allowing such a consumers in their individual and small that incorporated substitution between policy will in fact create challenges for group markets. EHB categories would be more difficult State regulators, and if so, whether those We believe that this change will not for States than evaluating plans with challenges are offset by the benefits of undermine coverage for vulnerable substitution within EHB categories, allowing more innovation in plan consumers or prevent coverage of because when comparing the allowed design in the form of between-category chronic conditions, because issuers will cost associated with particular types of substitution. Under the policy we are still be required to offer benefits services and limits on those services finalizing, States that determine that substantially equal to the EHB- with other services in the same EHB allowing substitution between EHB benchmark plan, cover each EHB category, the same dollar amount categories would pose excessive burden category without undue weight toward represents the same proportion of all on regulators have the authority to any, provide benefits for diverse withhold permission and avoid such segments of the population, and refrain 81 One commenter submitted what they described burden. from discrimination based on an as an example of how an issuer could use this In response to comments, we are individual’s age, expected length of life, policy to promote the use of high-value services, but their example was a case of adjustments to finalizing that substitution between present or predicted disability, degree of actuarial value, as opposed to an example of categories would only be permitted if medical dependency, quality of life, or substitution between EHB categories. the State in which the plan will be other health conditions.

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d. Premium Adjustment Percentage we proposed the following cost-sharing cost sharing early in the year, but the (§ 156.130) parameters for calendar year 2019. indexing of this parameter is required by statute, and a payment plan for the Section 1302(c)(4) of the PPACA Maximum Annual Limitation on Cost maximum annual limitation is directs the Secretary of HHS to Sharing for Calendar Year 2019 determine an annual premium inconsistent with industry practice. We Under § 156.130(a)(2), for the 2019 adjustment percentage, which is used to are finalizing the 2019 maximum calendar year, cost sharing for self-only set the rate of increase for three limitation on cost sharing as proposed. coverage may not exceed the dollar limit parameters detailed in the PPACA: The for calendar year 2014 increased by an e. Reduced Maximum Annual maximum annual limitation on cost amount equal to the product of that Limitation on Cost Sharing (§ 156.130) sharing (defined at § 156.130(a)); The amount and the premium adjustment Sections 1402(a) through (c) of the required contribution percentage used percentage for 2019, and for other than PPACA direct issuers to reduce cost to determine eligibility for certain self-only coverage, the limit is twice the sharing for EHBs for eligible individuals exemptions under section 5000A of the dollar limit for self-only coverage. enrolled in a silver level QHP. In the Code; 82 and the assessable payment Under § 156.130(d), these amounts must 2014 Payment Notice, we established amounts under section 4980H(a) and (b) be rounded down to the next lowest standards related to the provision of of the Code. Section 156.130(e) provides multiple of $50. Using the premium these cost-sharing reductions. that the premium adjustment percentage adjustment percentage of 1.2516634051 Specifically, in part 156, subpart E, we is the percentage (if any) by which the for 2019 as proposed above, and the specified that QHP issuers must provide average per capita premium for health 2014 maximum annual limitation on cost-sharing reductions by developing insurance coverage for the preceding plan variations, which are separate cost- calendar year exceeds such average per cost sharing of $6,350 for self-only sharing structures for each eligibility capita premium for health insurance for coverage, which was published by the 84 category. At § 156.420(a), we detailed 2013, and that this percentage will be IRS on May 2, 2013, we proposed that the structure of these plan variations published in the annual HHS notice of the 2019 maximum annual limitation on and specified that QHP issuers must benefit and payment parameters. cost sharing would be $7,900 for self- Under the methodology established in only coverage and $15,800 for other ensure that each silver plan variation the 2015 Payment Notice and amended than self-only coverage. This represents has an annual limitation on cost sharing in the 2015 Market Standards Rule for an approximately 7 percent increase no greater than the applicable reduced estimating average per capita premium above the 2018 parameters of $7,350 for maximum annual limitation on cost for purposes of calculating the premium self-only coverage and $14,700 for other sharing specified in the annual HHS adjustment percentage, the premium than self-only coverage. notice of benefit and payment adjustment percentage is calculated Comment: Several commenters parameters. Although the amount of the based on the estimates and projections supported the 7 percent increase in the reduction in the maximum annual of average per enrollee employer- maximum limitation on cost sharing, limitation on cost sharing is specified in sponsored insurance premiums from the saying it permits flexible plan design. section 1402(c)(1)(A) of the PPACA, NHEA, which are calculated by the CMS Many other commenters objected to the section 1402(c)(1)(B)(ii) of the PPACA Office of the Actuary. Accordingly, 2019 maximum limitation on cost states that the Secretary may adjust the using the employer-sponsored insurance sharing noting it is the highest increase cost-sharing limits to ensure that the data, the premium adjustment since 2014, saying the HHS resulting limits do not cause the AVs of percentage for 2019 is the percentage (if methodology no longer works when the health plans to exceed the levels any) by which the most recent NHEA paired with plan designs that offer less specified in section 1402(c)(1)(B)(i) of projection of per enrollee employer- generous EHBs and asked HHS to revisit the PPACA (that is, 73 percent, 87 sponsored insurance premiums for 2018 factors including the premium percent, or 94 percent, depending on the ($6,396) exceeds the most recent NHEA adjustment percentage used in the income of the enrollee). Accordingly, estimate of per enrollee employer- methodology. we proposed to continue to use a sponsored insurance premiums for 2013 Commenters noted that while many method we established in the 2014 ($5,110).83 Using this formula, the people with high health needs benefit Payment Notice for determining the premium adjustment percentage for from a maximum limitation on cost appropriate reductions in the maximum 2019 is 1.2516634051 or approximately sharing, the percentage increase in 2019 annual limitation on cost sharing for 25 percent. We are finalizing this index is more than twice the rate of medical cost-sharing plan variations. As we as proposed. Based on the proposed inflation and wage growth and far discussed above, the 2019 maximum 2019 premium adjustment percentage, higher than general inflation. Two annual limitation on cost sharing is commenters asked HHS to spread the $7,900 for self-only coverage and 82 As noted above, although the individual shared maximum limitation over the benefit $15,800 for other than self-only responsibility payment in section 5000A is reduced year to reduce the financial burden on coverage. We analyzed the effect on AV to $0, effective for months beginning after December chronically ill enrollees whose medical of the reductions in the maximum 31, 2018, individuals may still have a need to seek conditions require them to meet the annual limitation on cost sharing certain exemptions under section 5000A of the described in the statute to determine Code to obtain catastrophic coverage after 2018. limitation during the first month or 83 We note that the 2013 premium used for this quarter of the year. whether to adjust the reductions so that calculation has been updated to reflect the latest Response: The annual maximum the AV of a silver plan variation will not NHEA data. See ‘‘NHE Projections 2016–2025— limitation on cost sharing reflects exceed the AV specified in the statute. Tables’’ available at https://www.cms.gov/Research- Below, we describe our analysis for the Statistics-Data-and-Systems/Statistics-Trends-and- changes in the underlying economic Reports/NationalHealthExpendData/ data, as stated above. We are 2019 benefit year and our proposed NationalHealthAccountsProjected.html in Tables 1 sympathetic to the hardship faced by results. and 17. A detailed description of the NHE those whose health needs require them Consistent with our analysis in the projection methodology is available at https:// 2014 through 2018 Payment Notices, we www.cms.gov/Research-Statistics-Data-and- to meet their maximum limitation on Systems/Statistics-Trends-and-Reports/ developed three test silver level QHPs, NationalHealthExpendData/Downloads/ 84 See http://www.irs.gov/pub/irs-drop/rp-13- and analyzed the impact on AV of the proj2016.pdf. 25.pdf. reductions described in the PPACA to

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the estimated 2019 maximum annual percent FPL (2⁄3 reduction in the cost sharing, if the required reduction limitation on cost sharing for self-only maximum annual limitation on cost does not cause the AV of the QHP to coverage ($7,900). The test plan designs sharing), and 150 and 200 percent of the meet the specified level. We are are based on data collected for 2017 FPL (2⁄3 reduction), would not cause the finalizing these reductions as proposed. plan year QHP certification to ensure AV of any of the model QHPs to exceed In prior years, we have found that for that they represent a range of plan the statutorily specified AV levels (94 individuals with household incomes of designs that we expect issuers to offer and 87 percent, respectively). In 250 to 400 percent of the FPL, without at the silver level of coverage through contrast, the reduction in the maximum any change in other forms of cost the Exchanges. For 2019, the test silver annual limitation on cost sharing sharing, any reduction in the maximum level QHPs included a PPO with typical specified in the PPACA for enrollees annual limitation on cost sharing will cost-sharing structure ($7,900 annual with a household income between 200 cause an increase in AV that exceeds the limitation on cost sharing, $2,350 and 250 percent of FPL (1⁄2 reduction), maximum 70 percent level set in the deductible, and 20 percent in-network would cause the AVs of two of the test statute. In the Market Stabilization Rule, coinsurance rate), a PPO with a lower QHPs to exceed the specified AV level we analyzed the effect of reducing the annual limitation on cost sharing of 73 percent. As a result, we proposed maximum annual limitation on cost ($5,250 annual limitation on cost that the maximum annual limitation on sharing based on how we calculated the sharing, $3,050 deductible, and 20 cost sharing for enrollees in the 2017 2018 reduced maximum annual percent in-network coinsurance rate), benefit year with a household income and an HMO ($7,900 annual limitation between 200 and 250 percent of FPL be limitation on cost sharing. We stated that we were not certain what the AV on cost sharing, $3,375 deductible, 20 reduced by approximately 1⁄5, rather spread of plan designs will be under the percent in-network coinsurance rate, than 1⁄2. We further proposed that the and the following services with maximum annual limitation on cost finalized policy, whether issuers will in copayments that are not subject to the sharing for enrollees with a household fact reduce the AVs of their base silver deductible or coinsurance: $500 income between 100 and 200 percent of plans to the lower end of the de minimis inpatient stay per day, $500 emergency the FPL be reduced by approximately range, and whether issuers will retain plan designs above the 70 percent AV department visit, $25 primary care 2⁄3, as specified in the statute, and as office visit, and $55 specialist office shown in Table 10. These proposed range and that we would monitor 2018 visit). All three test QHPs meet the AV reductions in the maximum annual standard silver plan designs. As a result, requirements for silver level health limitation on cost sharing should we did not propose to reduce the plans. adequately account for unique plan maximum annual limitation on cost We then entered these test plans into designs that may not be captured by our sharing for individuals with household the proposed 2019 AV Calculator and three model QHPs. We also note that incomes between 250 and 400 percent 85 observed how the reductions in the selecting a reduction for the maximum FPL. maximum annual limitation on cost annual limitation on cost sharing that is We note that for 2019, as described in sharing specified in the PPACA affected less than the reduction specified in the § 156.135(d), States are permitted to the AVs of the plans. We found that the statute would not reduce the benefit submit for approval by HHS State- reduction in the maximum annual afforded to enrollees in aggregate specific datasets for use as the standard limitation on cost sharing specified in because QHP issuers are required to population to calculate AV.86 No State the PPACA for enrollees with a further reduce their annual limitation submitted a dataset by the September 1, household income between 100 and 150 on cost sharing, or reduce other types of 2017 deadline.

TABLE 10—REDUCTIONS IN MAXIMUM ANNUAL LIMITATION ON COST SHARING FOR 2019

Reduced maximum Reduced maximum annual limitation on annual limitation cost sharing Eligibility category on cost sharing for other than for self-only self-only coverage coverage for 2019 for 2019

Individuals eligible for cost-sharing reductions under § 155.305(g)(2)(i) (that is, 100–150 per- cent of FPL) ...... $2,600 $5,200 Individuals eligible for cost-sharing reductions under § 155.305(g)(2)(ii) (that is, 150–200 per- cent of FPL) ...... 2,600 5,200 Individuals eligible for cost-sharing reductions under § 155.305(g)(2)(iii) (that is, 200–250 per- cent of FPL) ...... 6,300 12,600

Comment: Several commenters consumers. Commenters asked HHS to of actual 2018 plans submitted for objected to reducing the maximum revise its test plan, with one commenter certification. We understand State-by- annual limitation on cost sharing by saying it does not reflect shifts in plan State plans may differ from the HHS test only one-fifth for enrollees with 200– network type and structure and, as a plans and we will continue to apply 250 percent FPL, calling the resulting result, hurts enrollees in this income statutory reductions in maximum reduced maximum annual limitation on level. annual limitation on cost sharing to cost sharing about 28 percent of income Response: When developing our test plans that most accurately represent in this category and too high for most plan, we generally try to match features those submitted for certification.

85 2014 Payment Notice, 78 FR at 15481; Market 86 The annual deadline for submitting State Resources/Regulations-and-Guidance/Downloads/ Stabilization Rule. 82 FR at 18370–18371. specific data for the AV Calculator was announced final-state-avc-guidance.pdf. August 15, 2014. See https://www.cms.gov/CCIIO/

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Comment: One commenter cautioned required to be offered at certain levels enrollees who are adults. HHS will HHS against introducing a new plan of coverage. However, HHS will consider ways to provide consumers variation for enrollees with incomes continue to require certification by a with additional information to assist in between 250–400 percent FPL in the member of the American Academy of comparison and selection of SADPs. absence of Federal payments to issuers Actuaries of the AV of the SADPs’ Comment: Some commenters for cost-sharing reductions, stating that coverage of EHB. HHS will consider questioned whether an SADP with a additional requirements to provide ways to use the certified AV to provide different AV from one year to the next reduced cost sharing would cause consumers with additional information would be considered the same plan for issuers to increase premium for all to assist in plan selection. the purposes of guaranteed renewability enrollees, and disproportionately hurt Comment: Several commenters or plan crosswalk. those not eligible for any or all opposed the proposal. They expressed Response: We note that guaranteed subsidies. concern that the removal of AV renewability requirements at 45 CFR Response: We share the commenter’s requirements for EHB would allow 147.106 generally do not apply to concern that additional reductions for SADP issuers to offer plans with little SADPs because they are excepted some enrollees could result in higher value, and that consumers would have benefit plans. HHS plans to develop a charges for others without other difficulty comparing SADPs. Several plan crosswalk hierarchy for Exchanges changes. We will continue to monitor commenters requested that HHS that use the Federal eligibility and plan AV and benefit design for impact establish a minimum AV of 70 percent enrollment platform that does not rely on premiums and out-of-pocket costs. for EHB covered by SADPs, and that the on SADPs being offered at either a high level of coverage of EHB of an SADP be or low level of coverage. f. Application to Stand-Alone Dental displayed to consumers when they Plans Inside the Exchange (§ 156.150) 3. Qualified Health Plan Minimum choose plans. Certification Standards Section 1302(d)(2) of the PPACA Several commenters supported the directs the Secretary to issue regulations proposal. They expected the proposal to a. Qualified Health Plan Certification on the calculation of AV and its result in greater plan choice for (Subpart C) application to the levels of coverage. In consumers. Some also expected SADPs HHS is committed to recognizing the 2013 EHB Rule, HHS finalized the to have greater ability to maintain States’ role as the primary regulator of requirements for the calculation of AV similar cost sharing from year to year, their insurance markets, and has made for stand-alone dental plans. since SADP issuers would not be a number of recent changes in the QHP Specifically, § 156.150 directs SADPs to required to alter their plans to meet a certification process to promote this cover the pediatric dental EHB at one of particular level of coverage. One role, and to limit duplicative oversight two AV levels, within an allowable de commenter observed that AV for over issuers. Previously, in the ¥ minimis variation of +/ 2 percentage pediatric EHB is a poor indicator of plan Guidance to States on Review of points. value for SADPs, since most SADP Qualified Health Plan Certification We proposed to remove the enrollees are adults. Some commenters Standards in Federally-facilitated requirement under § 156.150(b) for requested that HHS implement Marketplaces for Plan Years 2018 and SADP issuers to meet the low (70 consumer support tools to aid Later,87 released on April 13, 2017, we percent +/¥ 2 percentage points) or consumers in choosing among SADPs. ¥ outlined areas where, starting in plan high (85 percent +/ 2 percentage Response: In order to facilitate the year 2018, HHS began relying on State points) AV level. We are finalizing the implementation of consumer support reviews of QHP certification standards elimination of the requirement that tools related to SADPs in the future, we for States with FFEs, including States SADP issuers offer EHBs at the low or are not finalizing the elimination of the with FFEs that perform plan high levels of coverage. The PPACA requirement that SADPs’ AV for EHB be management functions in partnership does not specifically require SADP certified by a member of the American with HHS. We made these changes to issuers to offer coverage at the high or Academy of Actuaries. Further, we are streamline the QHP certification process low levels of AV. Removing the AV codifying an operational requirement and avoid duplicative Federal and State level requirement will give SADP that such certification be reported to the efforts. In that guidance, we provided issuers the opportunity to offer more Exchange, which issuers of SADPs have that in FFE States that do not perform flexible plan designs to consumers. In already been fulfilling, as part of the plan management functions, HHS will previous comments, SADP issuers had QHP certification process. continue to review QHP data, but will noted that it is difficult to meet the low We believe consumers benefit when rely on State review for licensure and AV requirement and offer preventive they have a range of plan choices, good standing standards required at including some plans with lower care without cost sharing, to which § 156.200(b)(4), and for network premiums and a lower AV. All SADPs consumers are accustomed in the large adequacy standards required at will continue to be required to cover the group market. Issuers could offer SADPs § 156.230. For FFEs in States performing pediatric dental EHB and to limit at varying premiums and levels of plan management functions, HHS will annual cost sharing on EHB. We expect coverage, so long as they continue to continue to rely on State plan data many SADPs with AVs at and above 70 offer the pediatric dental EHB and meet review for QHP certification standards, percent will remain available to the annual limitations on cost sharing. including for service area and consumers, even without a minimum We believe that this will allow prescription drug formulary outliers and AV standard, because SADPs often consumers to select from a greater non-discrimination in cost sharing. We provide preventive services without cost variety of plans and find one that is stated that we will continue to review sharing. While we acknowledge that more likely to meet their specific needs. plan data relating to Federal funds or We are not finalizing the elimination removing AV standards will make plan plan display on HealthCare.gov, such as of the requirement that SADP issuers comparison more difficult for some cost-sharing reductions structures, data certify their plans’ level of coverage of consumers, we note that standardized EHB, as proposed. We will no longer levels of coverage of pediatric dental 87 https://www.cms.gov/CCIIO/Resources/ require certification of the level of EHB are not a useful plan comparison Regulations-and-Guidance/Downloads/QHP- coverage since SADPs will no longer be tool for the large share of SADP Certifcation-Reviews-Guidance-41317.pdf.

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integrity, and plan crosswalks to standards that are at least equal to the would include the number of contracts implement annual re-enrollment at ‘‘reasonable access standard’’ defined in offered to ECPs for the applicable plan § 155.335(j). In the proposed rule, we § 156.230 and means to assess issuer year; the number of additional contracts reaffirmed this approach, and did not network adequacy. In States that do not an issuer expects to offer and the propose changes to this guidance. have the authority and means to timeframe of those planned To further streamline QHP conduct sufficient network adequacy negotiations; the names of the specific certification by avoiding duplicative reviews, we proposed for the 2019 ECPs to which the issuer has offered reviews, we also previously announced benefit year and beyond to rely on an contracts that are still pending; and in the QHP Rate Outlier Analysis for issuer’s accreditation (commercial, contingency plans for how the issuer’s Plan Year 2018 and Beyond 88 that we Medicaid, or Exchange) from an HHS- provider network, as currently designed, would rely on States to identify rate recognized accrediting entity, which we will provide adequate care to enrollees outliers for purposes of QHP proposed would include the three who might otherwise be cared for by certification,89 except for those States accrediting entities HHS has previously relevant ECP types that are missing from that do not have an Effective Rate recognized for the accreditation of the issuer’s provider network. Review Program. These changes were QHPs: The National Committee for We are finalizing as proposed the intended to allow States and issuers Quality Assurance, URAC, and policies for network adequacy greater flexibility in facilitating the Accreditation Association for (§ 156.230) and ECPs (§ 156.235). certification of plans best suited to their Ambulatory Health Care.90 Comment: Many commenters markets, while avoiding duplicative Unaccredited issuers would be required supported the network adequacy State and Federal activities. We did not to submit an access plan as part of the proposal, favoring the elimination of propose any changes to the approach QHP application. To show that the duplicative reviews, while others described in this guidance. QHP’s network meets the requirement opposed the proposal, stating that In the Market Stabilization final rule, in § 156.230(a)(2), the access plan would States’ and accrediting entities’ review HHS also finalized several standards to need to demonstrate that an issuer has processes do not do enough to ensure affirm the traditional role of States in standards and procedures in place to enrollees have adequate access to overseeing their health insurance maintain an adequate network necessary care. We also received many markets while reducing the regulatory consistent with the National Association comments that strongly opposed the burden of participating in Exchanges for of Insurance Commissioners’ Health continuation of the 20 percent ECP issuers for the 2018 plan year. Benefit Plan Network Access and standard and urged that HHS return to In the proposed rule, we continued Adequacy Model Act (the Model Act is the 30 percent ECP standard, expressing these efforts to enhance States’ role in available at http://www.naic.org/store/ concerns that the lower threshold requirement will result in access the QHP certification process. We free/MDL-74.pdf). We proposed to barriers to care for low-income proposed to continue to enhance the further coordinate with States to monitor network adequacy, for example, consumers. State flexibilities in QHP certification Response: We are finalizing as that began for plan year 2018 by through complaint tracking. With respect to QHP certification proposed our policies for network identifying additional areas where adequacy and ECP, as we believe they States are already performing reviews review for the essential community provider (ECP) standard, we proposed will continue to help stabilize the that are duplicative of the Federal QHP markets by reducing regulatory burden certification process and incorporating for the 2019 benefit year and beyond that we would continue to allow issuers on issuers, while also preserving these reviews into the QHP certification to use the ECP write-in process to adequate access to care, and process. In addition to empowering identify ECPs that are not on the HHS streamlining the QHP certification States, we believed these proposals list of available ECPs and would process. We have relied on State and would reduce issuer burden. maintain the 20 percent ECP standard. accrediting entities for this review in the We proposed to extend for the 2019 We believe this standard will past, and believe they provide benefit year and beyond policies related substantially reduce the regulatory appropriate review because both to QHP certification standards for burden on issuers while preserving typically have requirements in place network adequacy (§ 156.230) and adequate access to care provided by that specifically address access to essential community providers ECPs. As in previous years, if an issuer’s adequate networks. Many States already (§ 156.235) that we had finalized in the application does not satisfy the ECP address issuer network adequacy in Market Stabilization final rule for only standard, the issuer would be required State-specific regulation. The National plan year 2018. Specifically, with to include as part of its application for Committee for Quality Assurance respect to network adequacy, we QHP certification a satisfactory narrative requires accredited plans to create proposed to rely on the States’ reviews justification describing how the issuer’s standards for the number and in States in which an FFE is operating, provider networks, as presently geographic distribution of providers and provided the State has a sufficient constituted, provide an adequate level establish standards regarding the ability network adequacy review process. For of service for low-income and medically of consumers to access care. Similarly, the 2019 benefit year and beyond, we underserved individuals and how the URAC requires that plans have proper proposed to defer to the States’ reviews issuer plans to increase ECP methods in place to build, manage, and in States with the authority to enforce participation in the issuer’s provider evaluate their networks. We will also continue to monitor enrollee complaints 88 _ networks in future years. At a https://www.regtap.info/uploads/library/QHP for access concerns. RateOutlier_FAQ_5CR_071017.pdf. minimum, such narrative justification 89 This review generally identifies rates that are For plan years 2019 and later, HHS relatively low compared to other QHP rates in the 90 Recognition of Entities for the Accreditation of proposed to further expand the role of same rating area. The identification of a QHP rate Qualified Health Plans 77 FR 70163 (November 23, States in the QHP certification process as an outlier does not necessarily indicate 2012) and Approval of an Application by the for FFEs, including FFEs where the inappropriate rate development; instead, this Accreditation Association for Ambulatory Health information helps inform the determination of Care (AAAHC) To Be a Recognized Accrediting State performs plan management whether certifying the QHP to be offered on the Entity for the Accreditation of Qualified Health functions. Specifically, we proposed to Exchange would be in the interest of consumers. Plans 78 FR 77470 (December 23, 2013). defer to States for additional review

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areas, including accreditation c. Additional Standards Specific to premium payments. For the same requirements at § 156.275, compliance SHOP for Plan Years Beginning Prior to reason, we also proposed a narrower reviews at § 156.715, minimum January 1, 2018 (§ 156.285) version of § 156.285(b) as § 156.286(b), geographic area of the plan’s service As discussed in the following section, requiring only that issuers adhere to the area at § 155.1055, and quality we proposed and are finalizing a enrollment periods and processes improvement strategy reporting at modification to the regulatory established by the SHOP consistent with § 156.1130, if feasible and appropriate. requirements regarding additional § 155.726, and establish uniform In the proposed rule, we stated that we standards specific to SHOP for plan enrollment timelines and processes for believed States currently perform years beginning on or after January 1, qualified employers and group reviews in these areas that are 2018 and are introducing those members. We also proposed in duplicative of the Federal reviews for requirements in a new § 156.286. To § 156.286(c) to include only those QHP certification. As a result, we did reflect the proposal that the requirements from § 156.285(c) that do not relate to the payment and not believe this policy would require requirements currently in § 156.285 enrollment processes that we have States to undertake additional reviews would apply only for plan years proposed would no longer be required. or change existing reviews to match the beginning before January 1, 2018, we We proposed not to include a Federal standards for QHPs. We are not proposed to amend the heading of § 156.285 and add paragraph (f), to state paragraph mirroring paragraph (d) of finalizing the proposal to defer to States § 156.285. This reflects our proposal to for reviews in these four areas. that the section would only apply for plan years that begin prior to January 1, remove the requirements contained in Comment: Some commenters 2018. We discuss the new standards current § 155.735, and generally not to supported the proposal to defer the applicable for plan years beginning on impose coverage related timelines on additional review areas of accreditation, or after January 1, 2018 in the following issuers of QHPs through the SHOPs for minimum geographic area of the plan’s section. These changes will be effective plans beginning on or after January 1, service area, compliance reviews, and on the effective date of the final rule. 2018. We proposed to include a quality improvement strategy reporting Comments related to the proposed paragraph mirroring § 155.285(e) as to States for purpose of QHP approach for SHOP are discussed at the § 156.286(d). certification, while some commenters— beginning of section III.D.9 of this rule; Finally, under our proposed and including some States—opposed the we are finalizing these policies as finalized approach, SHOPs will no proposal, citing lack of State resources, proposed. longer be required to provide employee enrollment functionality. When insufficient staff, and the possibility of d. Additional Standards Specific to increased costs. enrollments are completed by working SHOP for Plan Years Beginning on or with SHOP issuers or SHOP-registered Response: We are not finalizing as After January 1, 2018 (§ 156.286) agents or brokers, which will be the case proposed the deferral to States for the As discussed above, we proposed to for FF–SHOPs, it may not always be review of service area; accreditation; make § 156.285, which describes the immediately apparent to the issuer compliance review—which in this requirements on QHP issuers whether the enrollment is through the context we interpreted to be review of participating in SHOPs to accept SHOP, and whether it is part of an an issuer’s organizational chart and enrollment and payment information employer’s offering a choice of plans. To compliance plan; and quality from a SHOP on behalf of an employer ensure that issuers offering QHPs improvement strategy reporting. Based or enrollee applicable only for plan through a SHOP do so in a manner that on comments received, we understand years beginning prior to January 1, 2018, is consistent with our new that States presently lack resources, and to modify the additional standards interpretation of the SHOP provisions of including staffing resources, to conduct specific to QHP issuers participating in the statute, we proposed to add new these reviews. We are less concerned SHOPs applicable for plan years paragraphs (e) and (f) in § 156.286. about the potential for Federal reviews beginning on or after January 1, 2018, These will require that QHP issuers to impose unnecessary additional through the introduction of a new offering a QHP through the SHOP accept burden on issuers, given information § 156.286. We proposed that new enrollments from groups in accordance from States and commenters that not all § 156.286 would include only those with the employer choice policies States currently perform these reviews. standards that have been applicable applicable to the SHOP under Our proposal was intended to eliminate under § 156.285 that would continue to § 155.706(b)(3), that they maintain duplication in reviews, not to compel apply to the SHOPs under the proposed processes sufficient to identify whether States to take on reviews that they are approach discussed earlier in this a group market enrollment is an not already performing. preamble, with minor modifications and enrollment through the SHOP, and they clarifications. maintain records of SHOP enrollments b. QHP Issuer Participation Standards We proposed to retain § 156.285(a) as for a period of 10 years following the § 156.286(a). However, we proposed to enrollment. Proposed paragraph (f) also Section 156.200 sets forth many of the require issuers to accept payment not would require issuers to utilize a standards a plan must meet to be only from the SHOP, but from a uniform enrollment form, as required by certified as a QHP. We proposed to qualified employer or enrollee or a section 1311(c)(1)(F) of the PPACA. As amend paragraph (b)(2) to add a cross SHOP, to reflect the proposal that a noted in the preamble to § 155.716, we reference to proposed § 155.706 to align SHOP would not be required to process intend to update the single employer with other changes made throughout enrollments and payments. We also application to reflect our changes in this final rule regarding changes to proposed not to include the requirement § 155.731. An issuer will be considered SHOP. Comments related to the currently in § 156.285(a)(4)(ii), which to satisfy this requirement if it uses that proposed approach for SHOP are prohibits issuers in FF–SHOPs from application form. discussed at the beginning of section using average enrollee premiums, as the Finally, we proposed in paragraph (g) III.D.9 of this rule. We are finalizing the FF–SHOPs and SBE–FPs for SHOP, to state that the requirements contained change as proposed. would no longer be involved in within § 156.286 are only applicable for

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plan years beginning on or after January necessary. We believe removing the regulations or policies in place that we 1, 2018. meaningful difference standard would should modify in order to better meet We are finalizing these policies as encourage plan design innovation, by the goals of affordability, quality, and proposed, with a minor change to providing more flexibility to issuers in access to care. § 156.286(a)(1) to reflect that SBEs can designing plans, and thus increase plan We also sought comment on how we continue operating their SHOPs under offerings and choice for consumers. may encourage value-based insurance current practices. These changes are We are finalizing this policy as design within the individual and small effective as of the effective date of this proposed. group markets and ways to support rule. Comment: While some commenters issuers in using cost sharing to Comment: We received a comment supported removing the meaningful incentivize more cost-effective enrollee that requested clarification on the issuer difference standard, several commenters behavior and higher quality health requirements at § 156.286(a)(1), opposed removing it, stating that the outcomes, in accordance with section regarding whether the proposal standard helps consumers avoid 2713(c) of the PHS Act. Currently, under precluded State Exchanges from confusion and improves the consumer our rules, issuers have considerable directing issuers offering QHPs in their shopping experience. Some commenters discretion in the design of cost-sharing SHOPs to accept payments only from stated that removing the standard would structures, subject to certain statutory the SHOP. decrease the comparative value of the AV requirements, non-discrimination Response: State Exchanges that do not data and increase the probability of laws and rules,91 and other applicable take advantage of the flexibilities duplicative QHP offerings, with one law, such as MHPAEA. described above for their SHOPs are commenter stating that removing the We would like to encourage issuers to encouraged to continue operating in a standard would encourage a offer HDHPs that can be paired with a manner consistent with § 156.285, or in proliferation of plans. One commenter health savings account (HSA) as a cost a way that best meets the needs of their stated that removing the standard could effective option for enrollees. While the small group market. The requirements lead to benefit designs aimed to attract proportion of available HSA-eligible in § 156.286(a)(1) represent minimum healthy enrollees and repel sick HDHPs has been stable in the FFEs, the SHOP requirements for issuers that enrollees. One commenter percentage of enrollees in HDHPs has would apply to all SHOPs, including recommended that we provide an decreased slightly over the last 3 years those that take advantage of the exception to the meaningful difference as there are certain technical barriers for flexibilities provided for by this final standard in cases where a comparison is issuers in offering HDHPs.92 We are rule, like the FF–SHOPs. We did not not feasible, while maintaining the particularly interested in exploring how intend that the leaner approach to SHOP requirement in cases where to use plan display options on prohibit State Exchanges from requiring comparisons are feasible. One HealthCare.gov to promote the QHP issuers in their SHOPs from commenter supported removing the availability of HDHPs to applicants, and accepting payments on behalf of a standard as long as certain conditions sought comment on how best to do so. qualified employer or enrollee from outside the scope of this rule were met. We are also interested in value-based sources other than the SHOP, as the FF– Response: We believe that removing insurance designs that focus on cost SHOPs had previously done. We have the meaningful difference standard will effective drug tiering structures; address clarified the regulatory text accordingly. not substantially increase the number of materially similar plans from the same overused, higher cost health services; e. Meaningful Difference Standard for issuer. Plan selection tools provide provide innovative network design that Qualified Health Plans in the Federally- consumers with information to incentivizes enrollees to use higher Facilitated Exchanges (§ 156.298) distinguish between plans and see quality care; and promote use of We proposed to remove § 156.298 to similarities or differences. With fewer preventive care and wellness services. eliminate meaningful difference plans on the Exchanges than in prior We solicited comments on how HHS standards for QHPs offered through an years, we believe removing this can better encourage these types of plan FFE or SBE–FP. Under this standard, in standard will encourage innovation and designs, and whether any existing order to be certified as a QHP, a plan increase plan offerings and choice for regulatory provisions or practices must be meaningfully different from all consumers, the benefits of which would discourage such designs. other QHPs offered by the same issuer outweigh any potential confusion. Comment: Many commenters of that plan within a service area and supported HHS exploring ways to level of coverage in the Exchange. As f. Other Considerations encourage innovation and value-based defined in § 156.298(b), QHPs are We sought comment on ways in insurance design. There was general considered meaningfully different from which HHS can foster market-driven support for HHS to drive towards other plans if a reasonable consumer programs that can improve the improved health outcomes and efficient would be able to identify one or more management and costs of care and that health care delivery. Commenters noted material differences among five key provide consumers with quality, person- that issuers should be encouraged to characteristics between the plan and centered coverage. As we stated in the 91 other plans to be offered by the same 2017 and 2018 Payment Notices, we We note that issuers are also subject to Federal civil rights laws, including Title VI of the Civil issuer. believe that innovative issuer, provider, Rights Act, section 504 of the Rehabilitation Act, This meaningful difference standard Exchange, and local programs or the Age Discrimination Act, section 1557 of the was implemented to make it easier for strategies can successfully promote and Affordable Care Act, and conscience and religious consumers to understand differences manage care, in a manner that freedom laws. 92 For instance, the maximum annual limitation between plans, and choose the right contributes to better health outcomes on cost sharing established at section 1302(c) of the plan option for them. However, with and lower rates while creating PPACA is increasing at a faster rate than the fewer issuers participating in the important differentiation opportunities maximum out of pocket cost limits for HDHPs Exchange, and fewer plans for for market participants. We sought under section 223 of the Code. Therefore, a plan that utilizes the maximum annual limitation on cost consumers to choose from, we proposed comment on ways in which we can sharing under the PPACA would not meet the to remove these standards, as we no facilitate such innovation, and in requirements to be an HDHP under the Code that longer believe the requirement is particular on whether there are could be paired with an HSA.

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engage in value-based insurance design standardized options, HHS should 6. Minimum Essential Coverage that utilizes clinical effectiveness consider other ways to incentivize a. Other Coverage That Qualifies as research and drives consumers to issuers to offer at least some QHPs with Minimum Essential Coverage efficient high quality providers. prescription drugs not subject to the (§ 156.602) Commenters questioned how services deductible. Other commenters noted would be deemed high-value and specific examples where issuers were A CHIP program is a type of cautioned against disincentivizing waiving cost sharing for high value government-sponsored coverage, consumers from seeking preventive and prescription drugs, such as those to treat defined under title XXI of the Act that wellness care, and care for chronic high blood pressure. Others suggested provides low-cost health coverage to conditions. Commenters suggested that that drug rebates could be available to children in low-income families that do HHS seek public comment on services consumers at the point of sale. not otherwise have health coverage. that are high value or leverage data from Additional commenters expressed States may be eligible to receive Federal comparative effectiveness research to concerns about changes to the 340B funds to initiate and expand such identify low-value services. drug discount program. programs. A CHIP buy-in program, a Commenters generally supported ‘‘full pay’’ option where a covered Response: We appreciate these increasing transparency of health family pays the full premium typically comments and will take them under information, but cautioned that without any Federal or State assistance, consideration. We note that the consumers would need education and often provides similar or identical Treasury Department and the IRS have tools in order to make information benefits as the State’s CHIP program jurisdiction over HSAs and HSA-eligible useful. Some requested that additional under title XXI of the Act (the title XXI HDHPs under section 223 of the Code. information be incorporated into CHIP program) for children in families HealthCare.gov, plan selection tools, the 4. Standards for Downstream and that do not financially qualify for the Summary of Benefits and Coverage, or Delegated Entities (§ 156.340) title XXI CHIP program.93 We proposed the out-of-pocket estimator tool. to amend § 156.602 to specifically Others suggested that specific Section 156.340 sets forth the designate as MEC CHIP buy-in programs alternative payment options be responsibilities of a QHP issuer and its that provide identical coverage to that allowable, such as reference pricing or applicable downstream entities. We title XXI CHIP program pursuant to the allowing issuers the flexibility to apply proposed to amend paragraph (a)(2) to Secretary’s authority under section the annual limitation on cost sharing to add a cross reference to proposed 5000A(f)(1)(E) of the Code. We sought accumulate differently in tiered § 155.706 to align with other changes comment on whether CHIP buy-in networks. made throughout this rule regarding programs that provide greater coverage Comments were mixed regarding SHOP. Comments related to the than the title XXI CHIP program should HSA-eligible HDHPs. Many commenters proposed approach for SHOP are be categorically designated as MEC. cautioned that HDHPs do not meet the discussed at the beginning of section Finally, we sought comment on whether needs of low-income consumers and III.D.9 of this rule. other types of government-sponsored urged that HHS provide appropriate We are finalizing the change as buy-in programs, such as Medicaid buy- explanations and ensure there are proposed. in programs, should be categorically consumer protections to make sure designated as MEC. We are not consumers make appropriate plan 5. Eligibility and Enrollment Standards finalizing the policy to categorically selections. Others noted that for Qualified Health Plan Issuers on designate as MEC CHIP buy-in programs HealthCare.gov should provide more State-Based Exchanges on the Federal that provide identical or greater information on how to use HDHPs and Platform (§ 156.350) coverage to the title XXI CHIP program. how to set up HSAs. Others commented Comment: Some commenters that promoting HDHPs would require Section 156.350 describes the supported categorically designating as training of Navigators and call center eligibility and enrollment standards for MEC CHIP buy-in programs that provide staff to handle additional questions. issuers that offer QHP coverage in the identical or greater coverage to the title Some noted that HealthCare.gov support SBE–FPs. Currently, § 156.350(a)(1) and XXI CHIP program because the should not answer questions more (2) state that for a QHP issuer to categorical designation would drive appropriate for HSA custodians. participate in an SBE–FP for SHOP, it down premiums and out-of-pocket costs Commenters noted the statutory and must comply with the requirements at for full-pay families, as well as regulatory issues with offering HSA- § 156.285(a)(4)(ii) and § 156.285(c)(5) eliminate deductibles. In addition, the eligible HDHPs on Exchanges, including and (c)(8)(iii), respectively. However, as change would permit consumers to the misalignment of annual limitations discussed elsewhere in this final rule, to move between the title XXI CHIP on cost sharing between the PPACA and align with our proposal regarding the program and CHIP buy-in programs the Code. Others requested that the IRS SHOPs, we proposed, and are finalizing, without experiencing a change in expand preventive care safe harbors that these referenced requirements at benefits. Other commenters expressed under section 223(c)(2)(C) of the Code to § 156.285 would not be applicable for concern that a categorical designation include services and benefits related to plan years beginning on or after January would prevent HHS from verifying that the management of chronic conditions 1, 2018, effective on the effective date of the benefits of a CHIP buy-in program and medications. this rule. Therefore, we proposed to are identical to the title XXI CHIP One commenter suggested that HHS amend § 156.350(a)(1) and (a)(2) to program which could lead to adverse provide subsidies in the form of HSA specify that they only apply through selection in the individual market or contributions instead of cost-sharing plan years beginning prior to January 1, erosion of CHIP benefits. reductions. Other commenters offered 2018. additional responses related to drug Comments related to the proposed 93 Under IRS Notice 2015–37, individuals who pricing, encouraging HHS to prioritize approach for SHOP are discussed at the may enroll in a CHIP buy-in program designated as MEC are eligible for MEC under the CHIP buy-in the transparency of drug pricing in beginning of section III.D.9 of this rule. program for purposes of the premium tax credit general, and other health care costs. We are finalizing the changes as under section 36B of the Code only if they are Others noted that with the removal of proposed. enrolled in the program.

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Response: Following the publication ‘‘substantially all’’ of the provisions of fewer benefits for the children in those of the proposed rule, Congress title I of the PPACA that apply to non- programs. designated qualified CHIP look-alike grandfathered individual health Response: After reviewing these plans as MEC. Section insurance coverage. comments, we agree that it is important 5000A(f)(1)(A)(iii) of the Code, as CHIP buy-in plans that are not CHIP for HHS to provide clear standards of amended by section 3002(g)(2)(A) of the look-alike plans may also continue to review for the MEC application process HEALTHY KIDS Act, specifically receive MEC recognition through the and to ensure that enrollees in these designates CHIP look-alike plans as MEC application process if the State can programs obtain benefits that are similar MEC. Section 2107 of the Social demonstrate that the coverage meets to the benefits in PPACA compliant Security Act, as amended by section substantially all the requirements of title coverage. We are not finalizing a 3002(g)(1) of the HEALTHY KIDS Act, I of the PPACA pertaining to non- ‘‘substantially resemble’’ standard. As defines a CHIP look-alike plan as a CHIP grandfathered, individual health described in the previous section, buy-in program that provides ‘‘benefits insurance coverage. section 5000A(f)(1)(A)(iii) of the Code, that are at least identical to the benefits Comment: One commenter stated that as amended by section 3002(g)(2)(A) of provided’’ by the title XXI CHIP States should have the flexibility to offer the HEALTHY KIDS Act, specifically program.94 Therefore, we are not a Medicaid buy-in program in an effort designates CHIP buy-in programs that finalizing the proposed changes to to stabilize the market and increase provide benefits that are at least § 156.602 since CHIP look-alike plans competition. identical to the benefits provided by the are now statutorily designated as MEC. Response: While we are not finalizing title XXI CHIP program as MEC. CHIP However, because the amendment that Medicaid buy-in programs are buy-in programs that do not provide identical or greater benefits than what is does not designate all CHIP buy-in designated as MEC, HHS invites all provided in the State’s title XXI program programs as MEC, we recognize that States to apply for their Medicaid buy- will be subject to the ‘‘substantially all’’ States and enrollees may have questions in programs to be recognized as MEC in standard for MEC recognition. regarding whether a particular State’s the process outlined in § 156.604. CHIP buy-in program is MEC. To 7. Quality Rating System (§ 156.1120) provide States and enrollees with b. Requirements for Recognition as We recognize that social risk factors certainty as to whether their coverage Minimum Essential Coverage for Types play a major role in health, and one of constitutes MEC, States will have the of Coverage Not Otherwise Designated our core objectives is to improve option to verify with HHS that their Minimum Essential Coverage in the patients’ outcomes including reducing CHIP buy-in program meets the Statute or This Subpart (§ 156.604) health disparities. In addition, we seek definition of a CHIP look-alike plan. A Under § 156.604, the Secretary may to ensure that the quality of care State may verify that a CHIP buy-in recognize coverage as MEC provided furnished by providers and health plans program is a qualified CHIP look-alike HHS determines that the plan meets is assessed as fairly and accurately as plan by submitting documentation to substantially all the requirements of title possible under HHS quality reporting HHS via the Health Insurance Oversight I of the PPACA pertaining to non- programs, including the Quality Rating System (HIOS) (as described in section grandfathered, individual health System established under section V of the October 31, 2013 Insurance insurance coverage (the ‘‘substantially 1311(c)(3) of the PPACA, while helping 95 Bulletin ) that provides a detailed all’’ standard). In the proposed rule, we to ensure that individuals and summary of the coverage provided by sought comment on whether HHS populations receive high quality, the CHIP buy-in program and the title should create a new standard of review person-centered care. In response to XXI CHIP program. Upon review and under which CHIP buy-in programs several comments we received from the comparison of the coverage, if HHS must ‘‘substantially resemble’’ the title Request for Information, we continue to determines that the CHIP buy-in XXI CHIP program under title XXI to assess ways to reduce burden and program provides at least the same qualify as MEC under § 156.604. We are promote State flexibility in the coverage as the title XXI CHIP program, not finalizing a substantially resemble implementation of all statutorily then HHS will confirm that the CHIP standard of review. required Exchange quality programs, buy-in program is a CHIP look-alike Comment: One commenter stated that including the Quality Rating System, plan. If HHS determines that the CHIP the ‘‘substantially resemble’’ standard is and we continue to prioritize strategies buy-in program does not provide at least more meaningful to State CHIP to improve the value for consumers. We the same coverage as the title XXI CHIP administrators than the ‘‘substantially received many comments as part of the program, then the plan sponsor may all’’ standard and would allow for more annual Quality Rating System Call work with HHS to modify the CHIP buy- reasonable evaluation by HHS of each Letter process in response to our request in program to offer at least the same individual buy-in program. Some for public comment on whether we coverage as the title XXI CHIP program. commenters stated the ‘‘substantially should account for social risk factors in In the alternative, the plan sponsor may resemble’’ standard must be better the Quality Rating System, which apply for MEC recognition through the defined and delineated to provide clear provides quality ratings (or star ratings process outlined in § 156.604 under guidelines on what constitutes a from 1 to 5 stars) that account for which HHS will evaluate whether the qualifying buy-in program. The member experience, medical care and CHIP buy-in program complies with commenters stated that, without clarity, health plan administration for QHPs, there would be confusion and States offered through an Exchange. We did 94 Extension of Continuing Appropriations Act, could be more arbitrary in their not propose amendments to the Quality 2018; HEALTHY KIDS Act; Federal Register Printing Savings Act of 2017, Public Law 115–120, decision-making for the scope of Rating System regulations in the 101 (2018). benefits. Other commenters stated that proposed rule. 95 See CCIIO Sub-regulatory Guidance: Process for the CHIP buy-in programs should be We sought comment as part of this Obtaining Recognition as Minimum Essential subject to the ‘‘substantially all’’ rulemaking on types of social risk Coverage (October 31, 2013). Available at http:// www.cms.gov/CCIIO/Resources/Regulations-and- standard that applies to other MEC factors that may be most appropriate, as Guidance/Downloads/mec-guidance-10-31- applicants. To provide a lesser standard well as the methods to account for 2013.pdf. to CHIP buy-in programs could result in social risk factors for QHP issuer quality

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reporting. Examples of social risk factors social connections and social isolation, applies in all circumstances where an include: Low income subsidy; race and stress, housing status, insurance status, issuer participating in an FFE performs ethnicity; and geographic area of employment, transportation, such a direct enrollment. A QHP issuer residence. Approaches to account for incarceration and refugee status. participating in an SBE–FP may also, social risk factors include stratifying Commenters also provided support for under § 156.350, directly enroll measure scores or risk adjustment of a stratifying measure data and not risk applicants, and must comply with the particular measure. We sought comment adjusting the Quality Rating System for requirements in § 156.1230(b)(2) as if it on which social risk factors could be social risk factors, to help plans identify were an issuer of QHPs on an FFE when used alone or in combination, current and distinguish efforts to improve using the direct enrollment pathway. data sources where this information quality from efforts to reduce would be available, and whether other disparities. Commenters stated that F. Part 157—Employer Interactions With data should be collected to better stratifying measure results by Exchanges and SHOP Participation capture the effects of social risk. socioeconomic status of patients within 1. Qualified Employer Participation Comment: Although many affected measures would highlight Process in a SHOP for Plan Years commenters expressed that accounting disparities, showing plans which Beginning Prior to January 1, 2018 for social risk factors in measuring subpopulations among their enrollees (§ 157.205) performance is contentious and most need targeted quality improvement As discussed in the following section, challenging, there was overall support efforts. for the need to address socioeconomic Response: We appreciate the we proposed to modify the regulatory factors that can affect quality in comments, and will take them under requirements regarding the qualified reporting of quality data and for CMS to consideration as we continue to assess employer participation process in a closely monitor the ongoing work of the the appropriateness and feasibility of SHOP for plan years beginning on or Office of the Assistant Secretary for accounting for social risk factors in the after January 1, 2018 and to introduce Planning and Evaluation and the Quality Rating System. We will those requirements in a new § 157.206. National Quality Forum regarding continue to collaborate with the Office To reflect the proposal that the socioeconomic status in health of the Assistant Secretary for Planning requirements currently in § 157.205 outcomes and quality. Commenters and Evaluation, the National Quality would apply only for plan years encouraged HHS to increase Forum, and with issuer, provider, and beginning before January 1, 2018, we opportunities for collaboration across all enrollee stakeholders to assess methods proposed to amend the heading of HHS quality rating programs, including for the collection and application of § 157.205 and add paragraph (h), to state the Exchange Quality Rating System, social risk factor information for future that the section would apply only for Medicare Advantage and Medicaid years of the Quality Rating System plan years that begin prior to January 1, health plans and provided some program. 2018. recommendations on methods of Comments related to the proposed 8. Direct Enrollment With the QHP accounting for social risk factors in the approach for SHOP are discussed at the Issuer in a Manner Considered To Be Quality Rating System. Some beginning of section III.D.9 of this rule. Through the Exchange (§ 156.1230) commenters did not support adjusting We are finalizing these policies as for socioeconomic status because they We proposed to amend paragraph proposed. These changes will be believe that could be counter-productive (b)(2) of § 156.1230 to conform with the effective on the effective date of this and potentially signal an expectation, proposed amendments to § 155.221. The rule. change requires that, prior to a QHP even acceptance, of lower outcomes for 2. Qualified Employer Participation issuer’s internet website being used to financially disadvantaged consumers. Process in a SHOP for Plan Years complete a QHP selection, the QHP Commenters provided examples of Beginning on or After January 1, 2018 issuer must engage a third-party entity types of social risk factors and (§ 157.206) combination of factors that would most in accordance with § 155.221 to appropriately account for QHP issuer demonstrate operational readiness and Section 157.205 describes quality reporting and clarified which compliance with applicable requirements for participating SHOP data is readily collected by Exchanges. requirements. For a discussion of the employers. To reflect the proposal to The types of social risk factors provisions of this final rule related to allow SHOPs to operate in a leaner mentioned included patient level data third-party entities performing fashion, we proposed several changes to about race and ethnicity; income level; operational readiness reviews, please the requirements related to qualified preferred language; disability status; see the preamble to § 155.221. We are employer participation process in a sexual orientation and gender identity; finalizing the amendments to § 156.1230 SHOP for plan years beginning on or psychological and behavioral status; as proposed. after January 1, 2018, and proposed to alcohol and tobacco use; residential Comment: One commenter requested introduce these requirements in address; low-income subsidy eligibility clarification on whether the proposed § 157.206. With the exception of the status; and per the recommendations of § 156.1230(b)(2) is meant to apply only proposed changes to the process the National Academies of Sciences, when an Exchange delegates the described here, the process will remain Engineering, and Medicine: Health and enrollment function to plans operating the same as in § 157.205. The proposals Medicine Division,96 the systematic in the individual market. described in this section will be collection of data in the following Response: No FFE has delegated the effective on the effective date of the domains: Depression, education, enrollment function to plans operating final rule. financial resource strain, intimate in the individual market. Paragraph (d) of § 157.205 requires a partner violence, physical activity, Notwithstanding this, § 156.1230(b) qualified employer to submit any permits QHPs in FFEs to directly enroll contribution towards the premiums of 96 IOM (Institute of Medicine). 2014. Capturing individual market applicants in a any qualified employee according to the social and behavioral domains and measures in manner that is considered through the standards and processes described in electronic health records: Phase 2. Washington, DC: The National Academies Press. https:// Exchange, to the extent permitted by § 155.705. Because we proposed that the www.nap.edu/read/18951/chapter/1. applicable State law. Paragraph (b)(2) requirements in § 155.705 regarding

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employer contribution methods will not § 157.205(e)(1) that employers must to terminate their participation in the apply for plan years beginning on or submit a new application to the SHOP SHOP in cases where the SHOP has after January 1, 2018, we also proposed if the employer makes a change that notified the issuer. We are making this that the requirement in § 157.705(d) will could end its eligibility under § 155.710 change to recognize that State-based not apply for those plan years. or withdraw from participation in the SHOPs may continue to provide these Paragraph (e)(1) of § 157.205 describes SHOP. Second, because under the notifications, in which case employers obligations of qualified employers to changes we have finalized elsewhere in should not be required to provide employees hired outside of the initial or this rule, SHOPs will not be required to duplicative notifications. Section annual open enrollment periods. We process group enrollments, and 156.206 will become effective as of the proposed in § 157.206(d) that qualified therefore will not necessarily effective date of the final rule. employers must provide employees communicate with QHP issuers about hired outside of the initial or annual employer eligibility determinations, we G. Part 158—Issuer Use of Premium open enrollment period with proposed to require employers to notify Revenue: Reporting and Rebate information about the enrollment the QHP issuer of an unfavorable Requirements process. We proposed that the eligibility determination. However, we 1. Reporting of Federal and State Taxes requirement in paragraph (e)(1) of proposed that the employer be required (§ 158.162) § 157.705, which requires qualified to provide the notification within 5 Section 2718 of the PHS Act requires employers to provide these employees business days of the end of any that Federal and State taxes be reported, with an enrollment period in applicable appeal process under but that such amounts be excluded from accordance with § 155.725(g), would not § 155.741. Specifically, the end of the premium revenue when calculating an be included in § 157.206, as the appeal process could occur when the issuer’s MLR and accompanying rebates. requirement in § 155.725(g) will not be time to file an appeal lapses without an However, the statute does not define applicable for plan years beginning on appeal being filed, when the appeal is or after January 1, 2018. We also rejected or dismissed, or when the what is included in Federal and State proposed that the requirement in appeal process concludes with an taxes. The MLR December 1, 2010, § 157.205(e)(2) to provide information adjudication by the appeals entity, as interim final rule (75 FR 74864) about the enrollment process in applicable. We also proposed in interprets this language and broadly accordance with § 155.725 would not paragraph (e)(3) to describe the describes Federal and State taxes that apply for plan years beginning on or employer’s obligations regarding loss of must be reported but are excluded from after January 1, 2018 to reflect that the eligibility to participate in a SHOP or premiums in the MLR and rebate process provided for in many of the termination of enrollment or coverage calculations, and Federal and State provisions in § 155.725 will not apply through the SHOP. Given that under the taxes that must be reported and are not for those plan years. approach finalized in this rule there will excluded from premiums in MLR and We also proposed that the not necessarily be communication rebate calculations. In order to provide requirements in § 157.205(f) regarding between the SHOP and a participating consistency and clarity for MLR the process for notifying the SHOP in QHP issuer regarding employer reporting, HHS amended § 158.162 in the event the eligibility status of an eligibility, enrollment, or terminations, the 2016 Payment Notice (80 FR 10750) employee, or employee’s dependent has there may be no way for the SHOP to to specify that all issuers must include changed would not apply for plan years notify an issuer in the event an employment taxes in earned premiums beginning on or after January 1, 2018. employer becomes ineligible to and must not deduct such taxes in the Under the approach finalized in this participate in SHOP. Therefore, we MLR and rebate calculations starting rule for plan years beginning on or after proposed to add paragraph (e)(3) to with the 2016 MLR reporting year. January 1, 2018, SHOPs will not be require employers to notify an issuer of However, we received several required to process employee a loss of eligibility to participate in comments in favor of allowing issuers to enrollment, so there will be no reason SHOP, or a desire to terminate SHOP deduct such taxes from these for all qualified employers to provide enrollment or coverage. calculations in response to the Request such information. We proposed in paragraph (f) of for Information. Therefore, in the Further, we proposed that the § 157.205 that the section would apply proposed rule, we invited comments on requirement in § 157.205(g) that for plan years beginning on or after whether, in order to encourage issuer qualified employers adhere to the January 1, 2018, only. participation and competition in the annual employer election period under Substantive comments relating to our markets, HHS should revise paragraph § 155.725(c) would not apply for plan proposals regarding SHOP are addressed (a)(2) and paragraph (b)(2)(iv) of years beginning on or after January 1, in section III.D.9 of this rule, as well as § 158.162 to allow all issuers to deduct 2018. Elsewhere, we finalized that the in the preamble discussing §§ 156.285 Federal and State employment taxes annual employer election period and 156.286. We are finalizing new from premiums in their MLR and rebate provision in § 155.725(c) will not apply § 157.206 as proposed, with minor calculations, starting with the 2017 MLR for those plan years, and this change changes to paragraphs (e)(2) and (e)(3). reporting year for reports to be filed by reflects that removal. As noted in the preamble to the SHOP July 31, 2018. Finally, we proposed in paragraph (e) sections in part 155, State Exchanges are We solicited comments on this of § 157.206 to include new encouraged to continue to operate their approach from all stakeholders, requirements for qualified employers SHOPs as they do today, or design a including on whether we should instead reflective of the proposed approach for SHOP within the bounds of the amend the MLR regulations to collect SHOPs generally. First, since we flexibilities being finalized within this the employment tax data separately proposed in § 155.716(f) that an rule. To ensure that SHOPs can from other tax data as an informational employer’s determination of eligibility continue to operate as they do today, we item on the MLR Annual Reporting to participate in the SHOP remains valid are providing flexibility to employers to Form to gather data to inform a decision until the employer makes a change that allow them not to notify issuers of regarding whether to amend the could end its eligibility under determinations of ineligibility to regulation for future years, and whether § 155.710(b), we proposed in participate in the SHOP or their desire changing the treatment of employment

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taxes would be likely to help improve whether a modification to the current MLR regulations require a substantial market stability and competition. policy would be appropriate. effort by issuers to accurately identify, Comment: We received almost an Specifically, while issuers already track and report QIA expenses. HHS has equal number of comments opposing report the employment tax amounts also observed that, between 2011 and and supporting exclusion of Federal and together with other taxes on the MLR 2015, issuers that did report QIA State employment taxes from earned reporting form, HHS intends to propose expenses have reported spending, on premium in the MLR and rebate changes to the MLR Annual Reporting average, a consistent percentage of calculations. Some who commented in Form to include a separate line that will premium on total QIA: approximately opposition noted that modifying the show these tax amounts for each issuer. 0.7 percent in 2011, and 0.8 percent in treatment of employment taxes would This will provide HHS with more up-to- 2012 through 2015. contradict HHS’s previous decision. date and consistent data on employment Given issuers’ relatively low and Other commenters expressed concern taxes to more precisely estimate how consistent reported expenditures on that such policy would raise MLRs potential modifications to the current QIA and the significant burden without producing greater value for policy may affect issuers and consumers associated with identifying, tracking consumers and would undermine and to determine whether such and reporting these expenditures, we consumer protections. Several modifications would likely improve proposed adding § 158.221(b)(8) to commenters stated that it is the market stability. permit issuers an option to report on uncertainty and the changes to the MLR their MLR reporting form a single QIA reporting parameters, rather than 2. Allocation of Expenses (§ 158.170) amount equal to 0.8 percent of earned employment taxes that negatively affect For a discussion of the proposed premium in the relevant State and market stability. In contrast, several amendment to § 158.170(b) regarding market, in lieu of tracking and reporting other commenters stated that excluding the description of the allocation method the issuer’s actual expenditures for QIA, employment taxes would improve for quality improvement activity (QIA) as defined in § 158.150 and § 158.151. market stability and provide incentives expenses and a summary of the The accompanying proposed for issuers to enter or remain in the comments received and responses amendments to § 158.170(b) would market. Some commenters stated that provided, please see the preamble to require issuers that elect the option to the PPACA provides for the exclusion of § 158.221. We are finalizing the change include 0.8 percent of earned premium taxes from the MLR calculation and that as proposed. for QIA expenses to indicate as such including employment taxes is 3. Formula for Calculating an Issuer’s when describing the allocation method inconsistent with the treatment of other Medical Loss Ratio (§ 158.221) used for QIA expenses. Issuers that taxes. Lastly, a number of commenters spend more than 0.8 percent of earned recommended that HHS gather We proposed amending § 158.221 by premium on QIA would have the option additional information on the impact of adding new paragraph (b)(8) to provide to report the total actual, higher amount excluding employment taxes on issuers with an option to report quality spent and, if choosing this option, consumers and issuers before making improvement activity (QIA) expenses as would have to report QIA in the five changes to the current policy. One a single fixed percentage of premium categories described in commenter encouraged HHS to consider amount starting with the 2017 MLR § 158.150(b)(2)(i)–(v), as well as comply the impact on issuers providing reporting year (for reports to be filed by with the allocation of expenses coverage on- versus off-Exchanges, as July 31, 2018). We also proposed requirements established under well as the potential double-counting conforming amendments to § 158.170(b) § 158.170. that may occur between excluding (Allocation of expenses) to recognize the We are finalizing this policy as employment taxes from premium while new proposed option for reporting QIA proposed, except that, in response to also including them in quality expenses. comments, we are specifying, as improvement activity (QIA) expenses. Consistent with the NAIC’s described below, how the optional QIA Response: HHS appreciates the recommendation to HHS,97 the MLR reporting method may be used across comments submitted regarding the interim final rule, published on affiliated issuers, markets, and years. treatment of Federal and State December 1, 2010 (75 FR 74863), allows Comment: We received comments employment taxes in the MLR and issuers to include in the MLR numerator from consumer and patient advocacy rebate calculations. We share the expenditures for five categories of groups, health insurance issuers, States, concern of some commenters that activities that improve health care and individuals regarding the proposal reversing the policy on the treatment of quality. Accordingly, issuers are to provide a standardized option to employment taxes only 1 year after the currently required to report QIA report QIA. Most commenters opposing policy became effective could contribute expenditures in alignment with the five the proposal stated that the current QIA to instability. We also continue to separate categories codified in requirements motivate issuers to invest disagree that the PPACA unambiguously § 158.150(b)(2)(i)–(v). Additionally, in improving the health and well-being requires exclusion of employment taxes § 158.170 requires issuers to use and of consumers, and therefore allowing from the MLR and rebate calculations. disclose specific allocation methods to issuers who spend nothing on QIA to However, it is our objective to explore report expenses, including QIA take a standardized credit for QIA and pursue all policy solutions that may expenditures. would disincentivize issuers from help stabilize the health insurance In the course of conducting the MLR making such investments. Many market. Therefore, after reviewing the audits, HHS observed that the current commenters stated that by giving issuers comments and recommendations, HHS credit for expenses that issuers may not 97 intends to gather data to help analyze National Association of Insurance actually incur, the proposal would Commissioners—Model Regulation Service, the potential impact on consumers and Regulation for Uniform Definitions and result in consumers receiving coverage issuers that would result from excluding Standardized Methodologies for Calculation of the of a lower value. Some commenters Federal and State employment taxes Medical Loss Ratio for Plan Years 2011, 2012 and expressed concern that the 0.8 percent from earned premium in the MLR and 2013 per Section 2718(b) of the Public Health standardized option would further Service Act (Oct 27, 2010), available at http:// rebate calculations, and perform www.naic.org/documents/committees_ex_mlr_reg_ provide a competitive advantage to additional data analysis to inform asadopted.pdf. issuers that get credit without investing

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in QIA. Many commenters stated that QIA reporting option, and in order to there is variation in QIA spending State regulators and consumers are address commenters’ concerns regarding between different issuers, we continue interested in knowing how much and the impact of the new QIA reporting to believe that 0.8 of earned premium is what types of innovative QIA are being option on the integrity of the MLR appropriate based on the average of implemented, and would lose access to program, we are specifying that issuers MLR data over 2011–2015, and that a this information under the proposal. and their affiliates that elect the single nationwide percentage provides These commenters were also concerned standardized QIA reporting option must the benefit of simplicity and reduces that reduced accountability would apply it consistently across all of their burdens associated with tracking and adversely affect the integrity of the MLR States and markets that are subject to reporting QIA expenses. As noted program. One commenter pointed out the MLR requirements in section 2718 previously, issuers will continue to have that premiums tend to increase faster of the Public Health Service Act. the option to report the actual than non-medical expenses so using a Further, similarly to some other expenditures and therefore will retain flat 0.8 percent may overstate QIA in the optional MLR reporting provisions,98 the ability to take full credit if these future. Most commenters who issuers and their affiliates that elect the expenditures exceed 0.8 percent of supported the proposal stated that the standardized QIA reporting option must premium. With respect to commenters’ current process for identifying, tracking apply this reporting method for a concern that QIA expenditures may not and reporting QIA expenses is minimum of 3 consecutive reporting grow proportionately to premium and burdensome, time consuming and years. In addition, we will require all that 0.8 percent may overstate issuers’ costly. Some commenters indicated that affiliated issuers to elect the same QIA average QIA expenditures in the future, it is hard for issuers to segregate QIA reporting method. These provisions will as well as commenters’ concern that expenses since QIA is ingrained ensure that the new QIA reporting they may lose access to the detailed QIA throughout issuers’ activities and the option is appropriately utilized by data, we also note that presently, issuers current process requires issuers to track issuers to simplify reporting, rather than continue to report to States QIA data individual employees’ time spent on a to inflate the MLR based on the that in some respects are even more specific task. A few commenters experience of a particular year. Further, detailed than the data previously suggested raising the standardized in the course of conducting the MLR collected by HHS. Therefore, the public credit to 1.0 percent of premiums, some audits, HHS observed that QIA and States retain the ability to access stated that 0.8 percent would be initiatives are often developed and this type of information. In addition, appropriate, while others contended administered at the parent company HHS will monitor QIA reporting and that 0.8 percent would be excessive. level and the costs are then prorated review available data, and may modify One commenter requested that HHS down to each issuer, State, and market the QIA reporting policy in the future if clarify whether issuers must make an segment using complex allocation HHS determines it to be necessary. election to use the optional QIA methods. Therefore, the requirement Finally, we note this change will also reporting method prior to the plan year; that the new QIA reporting option be help level the playing field among whether it must be elected for a applied in a consistent manner across issuers, since many issuers likely do minimum fixed period of years; and the all States, relevant markets, and engage in QIA but currently forego issuer, State, and market aggregation affiliates will additionally eliminate reporting because the burden of level(s) to which the election applies. gaming incentives for companies to use analyzing, documenting, tracking, One commenter recommended that the standardized 0.8 percent of allocating, and reporting QIA expenses issuers be allowed to retroactively premium QIA amount for some of their exceeds the benefits for MLR purposes. issuers, States, or markets and change the QIA reporting method with 4. Potential Adjustment to the MLR for simultaneously maximize the allocation respect to the 2 prior years included in a State’s Individual Market (Subpart C) of the actual QIA costs to their other the MLR calculation, while another We proposed to amend 45 CFR part commenter recommended that issuers issuers, States, or markets. This approach is also consistent with the fact 158, subpart C to modify the process be allowed to elect the standardized and criteria for the Secretary to QIA option for only some of their that the 0.8 percent of premium threshold was identified based on the determine whether to adjust the 80 markets. In contrast, another commenter average across all issuers, States, and percent MLR standard in the individual expressed concern that such approach markets. We note that the new QIA market in a State. Because the majority could lead to inadvertent or intentional reporting method is optional, and does of comments focused on the broader double-counting, particularly for those not prevent issuers from continuing to merits of amending subpart C, rather issuers that incur QIA expenses at the allocate and benefit from reporting the than on the specific sections, we holding group level, and recommended actual QIA expenses for each State and address all comments after summarizing that HHS require a consistent reporting market. While we acknowledge the proposed amendments to each methodology across all markets at the commenters’ concerns that the section. holding group level and for a minimum standardized QIA reporting option may Section 2718(d) of the PHS Act of 3 consecutive years. Several in some cases give issuers credit for provides that the Secretary may adjust commenters requested inclusion of activities that they do not perform, we the MLR standard in the individual certain other activities in QIA, which note that issuers also have financial market if the Secretary determines it we note is beyond the scope of the incentives to improve the health of their appropriate on account of the volatility amendments proposed in the proposed enrollees because healthier populations of the individual market due to the rule. incur lower medical costs, and reducing establishment of Exchanges. The MLR Response: We reviewed each of the the administrative burden associated December 1, 2010, interim final rule (75 comments and recommendations and with tracking QIA will free up funds FR 74864) set forth the framework for a are finalizing the amendments as that issuers can invest in QIA. State to request such an adjustment and proposed with the following Additionally, while we recognize that the process and criteria for the Secretary modification. In response to to determine whether to grant a State’s commenters’ request for clarification 98 Such as the reporting of group health insurance request. Subpart C of 45 CFR part 158 regarding the application of the new coverage with dual contracts in § 158.120(c). specifies that the adjustment request

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must be initiated by the State, the redesignate paragraph (d) as paragraph guidance,99 and non-grandfathered adjustment may be granted for up to 3 (a) and to revise the redesignated single risk pool coverage, in order to years at a time, the information that the paragraph to describe the information enable the Secretary to assess the State must provide to support its the State must submit regarding the situation in the State’s individual request, and the criteria that HHS may State’s individual health insurance market and to appropriately evaluate the consider in making a determination. It market, as outlined below. State’s proposal. Proposed new also requires the Secretary to invite We also proposed to replace the § 158.321(b) would also require the public comments on the adjustment requirement previously codified at State to report the RBC information at requests, allows States to hold optional § 158.321(d)(1) that a State provide the issuer level for each issuer actively public hearings, and enables States to detailed product-level enrollment and offering coverage in the State’s request reconsideration of adverse premium data with a requirement at individual market. A State would not be determinations. § 158.321(a)(2) to submit information required to provide information on Because in the current environment, it only on the total number of enrollees student health insurance coverage as generally is not the MLR standard in (life-years and covered lives) for each defined in § 147.145 or individual isolation but rather factors that, taken type of coverage sold or renewed in the market excepted benefits as defined in together, can contribute to instability of State’s individual market. Similarly, we § 148.220. the individual market in certain States, proposed to eliminate the requirement To further reduce the burden on the current framework in subpart C previously codified in § 158.321(d)(1) to States, we proposed to remove the restricts the States’ ability to obtain submit product-level premium data in requirements to provide net adjustments to the MLR standard as part favor of the total earned premium data underwriting profit for each issuer’s of innovative solutions for stabilizing in the proposed § 158.321(a)(1), and to total business in the State and after-tax their individual markets. Therefore, as eliminate the § 158.321(d)(1) profit and profit margin for the outlined below, we proposed to make requirement to submit the issuer’s individual market and total business in amendments throughout subpart C of individual market share. the State (§ 158.321(d)(2)(vii)), as well as part 158 to allow for adjustments to the We proposed to continue to require to rename the remaining requirement to individual market MLR standard in any States to include information on total provide the individual market ‘‘net State that demonstrates that a lower earned premium (proposed underwriting profit’’ to ‘‘net MLR standard could help stabilize its § 158.321(a)(1)) and total agent and underwriting gain’’ to more accurately individual market, and to streamline the broker commission expenses (proposed reflect the accounting term (proposed process for applying for such § 158.321(a)(3)) for each type of § 158.321(a)(4)). We also proposed to adjustments to reduce burdens for States coverage sold or renewed in the State’s delete the requirement to provide and HHS. individual market, as described in more information on estimated MLR rebates (§ 158.321(d)(2)(v)). Additionally, we a. Standard for Adjustment to the detail below, as well as the risk-based proposed to revise the language at Medical Loss Ratio (§ 158.301) capital (RBC) level (proposed § 158.321(a)(5)), which, due to the current paragraph § 158.321(d)(2)(ix), For the reasons described above, we proposed to be redesignated at proposed to amend § 158.301 to permit manner in which RBC is calculated, would only be appropriate to report at § 158.321(a)(6), to require the State to the Secretary to adjust the individual provide information not only on notices market MLR standard in any State if the the issuer level, rather than for each type of coverage. We also proposed to by issuers covered in § 158.321(a) of Secretary determines that there is a market exits, but also the equally or revise the accompanying regulation text reasonable likelihood that an more pertinent issuer notices of for these data elements for readability. adjustment to the 80 percent MLR beginning to offer coverage in the We further proposed that State requests standard will help stabilize the individual market, as well as ceasing or should include information on total individual market in that State. We are commencing offering individual market incurred claims (proposed finalizing the amendments as proposed. coverage on the Exchange or in specific § 158.321(a)(1)) for each type of geographic areas (for example, b. Information Regarding the State’s individual market coverage described counties); and to add a new § 158.321(c) Individual Health Insurance Market below, in lieu of the previous more to require similar information on issuers (§ 158.321) burdensome requirement to provide not actively offering coverage in the reported and estimated individual We proposed to amend § 158.321 to individual market that have indicated market MLRs (§ 158.321(d)(2)(ii) modify the information that a State must an intent to enter or exit the individual through (iii)). submit to the Secretary with its request market, including ceasing or We proposed to modify these for an adjustment to the 80 percent MLR commencing offering individual market requirements to require States to only standard in its individual market. coverage on the Exchange or in specific include the information for each issuer Specifically, because we sought to make geographic areas. Lastly, we recognize actively offering individual market the MLR adjustment process less that in many situations the information coverage. We also proposed to add a burdensome on States and make proposed to be required in § 158.321(a) new § 158.321(b) to require that a State adjustments available to enable States to will only be available for the preceding request include the individual market develop innovative solutions for calendar year, but we proposed to data required in the proposed new stabilizing their individual markets, we provide States with an option to also § 158.321(a)(1) through (4) and (6) proposed to remove the requirements include information for the current year separately for each issuer actively that the State must describe the State (where available), which may be more MLR standard and formula for assessing offering individual market plans in that State group by the following categories, compliance (§ 158.321(a)), its market 99 See, for example, CMS ‘‘Insurance Standards withdrawal requirements (§ 158.321(b)), as applicable: On-Exchange, off- Bulletin Series—Information—Extension of and the mechanisms available to the Exchange, grandfathered health plans as Transitional Policy through Calendar Year 2018 State to provide consumers with options defined in § 147.140, coverage that (February 23, 2017) available at https:// meets the criteria for transitional www.cms.gov/CCIIO/Resources/Regulations-and- for alternate coverage (§ 158.321(c)). Guidance/Downloads/Extension-Transitional- Additionally, we proposed to policies outlined in applicable Policy-CY2018.pdf.

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relevant if a State makes a request in a financial performance of issuers actively other relevant information submitted by later part of the year. offering individual market coverage on- the State. We are finalizing the amendments as Exchange, off-Exchange, grandfathered We are finalizing the amendments as proposed, with one correction to health plans as defined in § 147.140, proposed. § 158.321(b) to indicate that the coverage that meets the criteria for e. Treatment as a Public Document information required in paragraph transitional policies outlined in (§ 158.341) § 158.321(a)(5) is the only information applicable guidance, and non- Because the format in which States that must be provided at the issuer grandfathered single risk pool coverage; may submit requests for adjustments level. the number of issuers reasonably likely may not comply with Federal to cease or begin offering such c. Proposal for Adjusted Medical Loss requirements for documents posted on Ratio (§ 158.322) individual market coverage in the State; Federal websites, some of these To reduce the burden on States, we and the likelihood that an adjustment documents may not be able to be posted proposed to remove paragraphs (a), (c) would increase competition in the directly to the applicable Federal and (d) of § 158.322, which would State’s individual market, including in website. For example, a State may remove the requirements for a State to underserved areas (proposed submit spreadsheets containing data or justify how its proposed adjustment was § 158.330(a)). We proposed to delete the copies of issuer letters in a format that determined, and to estimate rebates that existing criteria captured at § 158.330(b) is not accessible for individuals with would be paid with and without an related to consideration of the number visual impairments. However, HHS is adjustment because HHS can make of individual market enrollees covered committed to transparency and making these estimates instead of the State. by issuers that are reasonably likely to this information promptly available to Consistent with our proposed changes exit the State’s individual market absent the public. HHS is also committed to to § 158.301, we proposed to revise the requested adjustment because the providing accessible information to § 158.322 to require the State to both goal of a State request for adjustment members of the public, including provide its proposed, adjusted MLR may be to ensure that health insurance individuals with disabilities, and will standard and explain how this proposed coverage is available to all, rather than provide such individuals with standard would help stabilize its a certain percentage of, consumers who accessible copies of documents individual market. We also proposed to want it, and that consumers not only submitted by States unless doing so delete current paragraph (b), which have coverage, but also a choice of would impose an undue burden on the requires an explanation of how an several issuers. We proposed agency. Therefore, we proposed to adjustment would permit issuers to conforming amendments to the criteria amend § 158.341 to reflect that Federal adjust current business models and currently captured at § 158.330(c), requirements for documents posted on practices in order to meet an 80 percent proposed to be redesignated at Federal websites may not permit these MLR as soon as is practicable, to further § 158.330(b), regarding whether an documents to be posted, and to specify reduce burden on States submitting adjustment might improve consumers’ that instructions for the public to access adjustment requests. access to agents and brokers. Similar to information on requests for adjustment We are finalizing the amendments as the proposed amendments to § 158.321 to the MLR standard submitted by States proposed. described above to remove the will be provided on the Secretary’s d. Criteria for Assessing Request for requirement for States to provide internet website. We are finalizing the Adjustment to the Medical Loss Ratio information on available mechanisms to amendments as proposed, with a non- (§ 158.330) provide alternate coverage, we proposed substantive change to the regulatory text. Section 158.330 lists the criteria that to replace the current criteria outlined at the Secretary may consider in § 158.330(d)(1)–(5) with consideration f. Subsequent Requests for Adjustment determining whether to approve a State of information on the capacity of any to the Medical Loss Ratio (§ 158.350) new issuers or issuers remaining in the request to adjust the 80 percent MLR We proposed to make conforming individual market to write additional standard for the individual market. We amendments to § 158.350, which business in the event one or more proposed amendments throughout the describes the information that a State section to reflect the proposal in issuers were to cease or begin offering must submit with a subsequent request § 158.301 to allow adjustments if the individual market coverage on for an adjustment to the MLR standard, Secretary determines the adjustment Exchanges, in certain geographic areas, to make this information consistent with would help stabilize the individual or in the entire individual market in the our proposed changes to § 158.301 and market in that State, and the proposed State (proposed § 158.330(c)). We § 158.330. We are finalizing the changes to the information requirements proposed to retain and modify the amendments as proposed. in § 158.321. Specifically, we proposed existing criteria at § 158.330(e), The following is a summary of the conforming amendments to the proposed to be redesignated at public comments received on these introductory text of § 158.330 to provide § 158.330(d), on the impact on proposals and our responses. that the Secretary may consider the premiums charged, and on benefits and Comment: We received comments identified criteria when assessing cost sharing provided, to consumers by from consumer and patient advocacy whether an adjustment to the individual issuers remaining in or entering the groups, health insurance issuers, States, market MLR standard would be individual market in the event one or and individuals regarding the proposal reasonably likely to help stabilize the more issuers were to cease offering to modify the process for submission of individual market in a State that has individual market coverage on the State requests to adjust the individual requested such an adjustment. We Exchange, in certain geographic areas, market MLR standard and the proposed to replace the information or in the entire individual market in the accompanying criteria for the Secretary currently outlined at § 158.330(a)(1)–(4) State. Finally, we proposed to retain the to determine whether to adjust the 80 regarding individual market issuers existing criteria at § 158.330(f), percent MLR standard in the individual reasonably likely to exit the State with proposed to be redesignated at market in a State. The majority of information regarding the number and § 158.330(e), for consideration of any comments focused on the merits of the

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proposed amendments to subpart C as a stability of their markets. We incentives for issuers that contemplate whole, rather than offering comments acknowledge the concerns expressed by entering a market. These include the on the specific sections of subpart C. many commenters that the adjustments credibility adjustment for smaller Most commenters opposing the to the individual market MLR standard issuers in § 158.323 and the options to proposals stated that it is unlikely that should not undermine consumer defer MLR and rebate calculation for the MLR standard is a primary driver of protections and that the integrity of the newer business in § 158.121 and to limit market instability and that most insurers adjustment review process should not the total rebate payment in § 158.240(d). already meet or exceed the MLR be compromised. However, we believe IV. Collection of Information standard. These commenters stated that that if States can develop strategies Requirements lowering the MLR standard would involving an adjusted MLR standard undermine one of the few consumer that States can demonstrate would be Under the Paperwork Reduction Act protections and lead to higher reasonably likely to lead to a more of 1995, we are required to provide 30- premiums with consumers receiving robust and stable individual market, day notice in the Federal Register and lower value for those premiums, then this would benefit consumers and solicit public comment before a without strengthening the market. Many ultimately lead to higher quality and collection of information requirement is commenters focused on the benefits the more affordable coverage. We note that submitted to the Office of Management MLR rule has delivered to consumers the amendments to subpart C are not and Budget (OMB) for review and and objected to weakening the rule. intended to reduce the overall burden of approval. This final rule contains Several commenters expressed concern proof on States applying for information collection requirements that the proposal could lead to adjustments, but rather require States to (ICRs) that are subject to review by discrepancies in standards and access to provide more pertinent information and OMB. A description of these provisions care. Several commenters disagreed remove duplicative, burdensome is given in the following paragraphs with the proposed elimination or requirements, such as those that with an estimate of the annual burden, reduction of various requirements on mandate States submit data that is summarized in Table 12. To fairly States seeking adjustments due to otherwise publicly available to both evaluate whether an information concerns over the possibility of arbitrary HHS and consumers. Given that the goal collection should be approved by OMB, and unjustified requests, inadequately of the amendments to subpart C is to section 3506(c)(2)(A) of the Paperwork rigorous review, and a decrease in provide States the flexibility to innovate Reduction Act of 1995 (PRA) requires transparency. Most commenters who and pursue the best solutions for their that we solicited comment on the supported the proposals expressed markets, we believe that it would be following issues: appreciation that the proposals would inconsistent to impose up-front • The need for the information give greater flexibility to the States. restrictions on how much or what collection and its usefulness in carrying Some of these commenters stated that a direction of an adjustment a State may out the proper functions of our agency. lower MLR standard may have seek. For the same reason, we will • The accuracy of our estimate of the competitive benefits that outweigh determine the effective date for each information collection burden. potential costs and that States are in the adjustment in consultation with the • The quality, utility, and clarity of best position to assess that tradeoff. respective State and based on the timing the information to be collected. Several commenters stated that the of the request submitted by the State, • Recommendations to minimize the proposals could incentivize issuer but will, as appropriate, take information collection burden on the expansion and innovation. commenters’ recommendations on the affected public, including automated Additionally, several commenters proposed rule into consideration when collection techniques. recommended that States be allowed to making those determinations. We We solicited public comment on each only lower (not increase) the MLR further clarify that a State should of the required issues under section include an effective date and duration 3506(c)(2)(A) of the PRA for the standard, and that adjustments not be 100 effective prior to 2020 in order to give (for up to 3 MLR reporting years ) for following information collection issuers time to incorporate adjusted the requested adjustment to the requirements. individual market MLR standard as part MLR standards into issuers’ market of its proposal. In addition, we note A. Wage Estimates participation and pricing decisions. there will be opportunities for public Lastly, one commenter recommended To derive wage estimates, we comment on individual State allowing States to adjust the MLR generally used data from the Bureau of adjustment requests. Sections 158.342 standard for only specific issuers, such Labor Statistics to derive average labor and 158.343 are being retained in their as new entrants, while another costs (including a 100 percent increase current form, which require the commenter urged HHS to disallow this for fringe benefits and overhead) for Secretary to invite public comment on in order to not disadvantage established estimating the burden associated with State adjustment requests and provide 101 issuers and to avoid encouraging such the ICRs. Table 11 in this final rule for optional State public hearings, issuers to leave the market. presents the mean hourly wage respectively. Lastly, because we (calculated at 100 percent of salary), the Response: We are finalizing the interpret the statute as only permitting cost of fringe benefits and overhead, and proposed amendments to subpart C as the Secretary to adjust the MLR the adjusted hourly wage. proposed, with one technical correction standard for the entire individual As indicated, employee hourly wage to § 158.321(b) to indicate that the market within a State, we are not able estimates have been adjusted by a factor information required in paragraph to allow issuer-specific adjustments § 158.321(a)(5) is the only section that within a State. However, we note that 101 See May 2016 Bureau of Labor Statistics, must be provided at the issuer level. We there are several other provisions in the Occupational Employment Statistics, National appreciate both the comments MLR regulations that are designed to Occupational Employment and Wage Estimates at _ highlighting the benefits of the current recognize the special circumstances of https://www.bls.gov/oes/current/oes nat.htm. For State Government Employees see NAICS 999200— MLR rule, as well as the comments smaller and newer plans, and provide State Government, excluding schools and hospitals supporting our efforts to provide more (OES Designation) https://www.bls.gov/oes/current/ flexibility to States to improve the 100 See 45 CFR 158.311. naics4_999200.htm.

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of 100 percent. This is necessarily a because methods of estimating these doubling the hourly wage to estimate rough adjustment, both because fringe costs vary widely across studies. total cost is a reasonably accurate benefits and overhead costs vary Nonetheless, there is no practical estimation method. significantly across employers, and alternative, and we believe that

TABLE 11—ADJUSTED HOURLY WAGES USED IN BURDEN ESTIMATES

Mean Fringe Adjusted Occupational hourly benefits and hourly Occupation title code wage overhead wage ($/hr.) ($/hr.) ($/hr.)

Business operation specialist * ...... 13–1199 $31.59 $31.59 $63.18 Operations Manager ...... 11–1021 58.70 58.70 117.40 Software Developers, Systems Software ...... 15–1133 53.17 53.17 106.34 Actuary ...... 15–2011 54.87 54.87 109.74 Actuary * ...... 15–2011 40.41 40.41 80.82 Financial Examiner * ...... 13–2061 33.02 33.02 66.04 Financial Analyst * ...... 13–2051 34.39 34.39 68.78 Financial Manager * ...... 11–3031 45.83 45.83 91.66 Lawyer * ...... 23–1011 44.87 44.87 89.74 Secretaries and Administrative Assistants, Except Legal, Medical, and Ex- ecutive ...... 43–6014 17.38 17.38 34.76 Commissioner ** ...... 58.45 58.45 116.90 Market Research Analyst ...... 13–1161 33.95 33.95 67.90 Medical Records Technician ...... 29–2071 19.93 19.93 39.86 Psychiatrist ...... 29–1066 96.26 96.26 192.52 * Denotes occupations where wages were obtained for State Government employees (https://www.bls.gov/oes/current/naics4_999200.htm). ** Data on compensation of State Insurance Commissioners collected by the Council of State Governments and compiled by Ballotpedia (http:// www.ballotpedia.org). The wage data used in the burden estimates include the cost of fringe benefits and the adjusted hourly wage.

B. ICRs Regarding State Flexibility for evidence and analysis by August 1st, 2 Payment Appeals, for comment on Risk Adjustment (§ 153.320) calendar years prior to the beginning of December 28, 2017, and intend to We are finalizing our proposal to the applicable benefit year (for example, update it to account for this change in allow State regulators to request a August 1, 2018, for the 2020 benefit burden. year). The burden associated with this reduction, beginning for the 2020 C. ICRs Regarding Risk Adjustment Data requirement is the time and effort for benefit year, to risk adjustment transfers Validation (§ 153.630) in the individual, small group or merged the State regulators to submit its request markets. We are finalizing the and supporting evidence and analysis to We finalize that, beginning with 2017 requirement for any State requesting HHS. We are updating the burden benefit year risk adjustment data this reduction to otherwise applicable estimates from those proposed based on validation, issuers with 500 billable transfers to submit its request with the the State request and supporting member months or fewer Statewide that supporting evidence and analysis to evidence and analysis requirements we elect to establish and submit data to an HHS identifying the State-specific are finalizing in this rule. We estimate EDGE server will not be subject to the factors that warrant the adjustment to submitting the request and supporting requirement to hire an initial validation more precisely account for the evidence and analysis will take a auditor or submit initial validation audit differences in actuarial risk in the business operations specialist 40 hours results. We note that, beginning with State’s individual, small group or (at a rate of $63.18 per hour) to prepare 2018 benefit year risk adjustment data merged market. Additionally, the State the request and 20 hours for a senior validation, these issuers will not be must submit supporting evidence and manager (at a rate of $117.40 per hour) subject to random sampling under the analysis demonstrating the reduction to review the request and transmit it materiality threshold discussed below, percentage requested is appropriate. electronically to HHS. We estimate that and will continue to not be subject to This evidence and analysis justifying each State seeking a reduction will the requirement to hire an initial the percentage requested must either incur a burden of 60 hours at a cost of validation auditor or submit initial demonstrate the set of factors and the approximately $4,875 per State to validation audit results. As 2016 benefit percentage by which those factors comply with this reporting requirement year risk adjustment data validation will warrant an adjustment to more precisely (40 hours for the insurance operations be another pilot year, we are also account for the differences in actuarial analyst and 20 hours for the senior finalizing the postponement of the risk in the State’s individual, small manager). Although we are unable to application of the materiality threshold group or merged market compared to precisely estimate the number of States to the 2018 benefit year. Under this the national norm, or it must that will make this request, we expect policy, all issuers of risk adjustment demonstrate the requested reduction in that no more than 25 States will make covered plans will be required to risk adjustment payments would be so these requests annually, resulting in a conduct an initial validation audit for small for issuers who would receive risk total annual burden of approximately the 2017 benefit year risk adjustment adjustment payments, that the reduction 1,500 hours with an associated total cost data validation, other than issuers with would have a de minimis effect on the of $121,880. We published a revised 500 billable member months or fewer necessary premium increase to cover the information collection approved under Statewide as discussed above. affected issuer or issuers’ reduced OMB control number 0938–1155: Beginning with the 2018 benefit year, payments. States are required to submit Standards Related to Reinsurance, Risk issuers below the $15 million premium the requests with the supporting Corridors, Risk Adjustment, and materiality threshold will not be

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required to conduct an initial validation must ensure that it is accompanied by Number 0938–1155: Standards Related audit every year, but rather, HHS will an attestation from the provider that to Reinsurance, Risk Corridors, Risk conduct random and targeted sampling applicable State privacy laws prevent Adjustment, and Payment Appeals, to under which issuers below the him or her from providing the complete account for this additional burden. materiality threshold would be subject mental or behavioral health record. D. ICRs Regarding Health Insurance to an initial validation audit HHS expects that this provision may Issuer Rate Increases: Disclosure and approximately every 3 years. affect 10 percent of issuers or HHS estimates that not requiring approximately 70 issuers in States with Review Requirements—Applicability issuers that have 500 or fewer billable stricter privacy laws on medical records. (§ 154.103) member months Statewide to conduct Based on our experience with the first We are finalizing the proposal to an initial validation audit beginning in pilot year risk adjustment data exempt student health insurance the 2017 benefit year will exempt 50 validation audits, we estimate that coverage as defined in § 147.145 from issuers from an initial validation audit approximately 40 enrollees in any the Federal rate review requirements. and reduce administrative costs for each initial validation audit sample of 200 Because we will no longer be reviewing issuer by 828 hours with an estimated enrollees could be affected. Since the reasonableness of rate increases for cost reduction on average of up to providers routinely prepare mental or student health insurance coverage, we $100,000. The total burden reduction for behavioral health assessments to expect to collect less information for the all 50 issuers will be 41,400 hours with validate diagnoses, we believe the slight 2019 plan or policy year than collected an associated reduction in cost of additional burden is the time it would for previous years. This will reduce $3,520,000. The postponement of the take to seek patient consent to provide burden related to the submission and effectiveness of the materiality the assessment, in States that require review for issuers and States. We threshold to the 2018 benefit year will such permission, to review and edit the estimate that 75 student health not impact issuer burden relative to preexisting assessment for each medical insurance issuers will no longer be previous estimates for the risk record to include the data elements required to submit rate increases to adjustment data validation program specified in § 153.630(b)(6), and to attest HHS. We estimate that each rate review included in the 2014 and 2015 Payment that relevant State privacy laws prohibit submission takes 11 hours for an Notices, particularly given that the him or her from providing the complete actuary (at a rate of $109.74 per hour) program has been converted to a pilot mental or behavioral health record. to prepare, and that each issuer will for the first 2 years of operation. We are Comment: Several commenters stated submit an average of 2.5 plans, at an revising the current information that obtaining patient consent and estimated annual cost of $3,018, collection approved under OMB control provider attestations for mental or resulting in a total reduction in the number 0938–1155: Standards Related behavioral health assessments would annual burden to issuers of to Reinsurance, Risk Corridors, Risk impose a significant administrative, approximately 2,063 hours and an Adjustment, and Payment Appeals, to professional, and personal burden on associated reduction in cost of account for this reduction in burden. issuers, providers, and patients, while approximately $226,339. We estimate For risk adjustment data validation, one commenter stated that this that States will no longer submit rate HHS requires issuers to document flexibility could reduce administrative increases for 188 student health mental and behavioral health records burden if issuers could develop a insurance plans to HHS. We estimate a included in audit sampling. Without the standard form for physicians to sign. reduction in burden to States of one necessary mental and behavioral health Response: As noted above, HHS hour per plan for an actuary (at a rate information for each sample, the believes that the policy to permit the of $80.82 per hour) to prepare and diagnosis code for an applicable use of existing mental or behavioral electronically submit the appropriate enrollee cannot be validated and, health assessments may result in a slight materials, for a total reduction in burden therefore, it would be rejected during increase in the burden on issuers and of approximately 188 hours annually risk adjustment data validation. providers, primarily due to the new with an associated cost reduction of Because providers may be prevented provider attestation requirement. approximately $15,194. We will revise by some State privacy laws from We estimate it will take a medical our current burden estimate approved furnishing a full mental health or records technician (at an hourly rate of under OMB control number 0938–1141: behavioral health record, we are $39.86) 15 minutes to obtain consent Rate Increase Disclosure and Review amending § 153.630(b)(6) to allow from each patient, or approximately 10 Reporting Requirements, to reflect the issuers an additional avenue to achieve burden hours at an estimated cost of reduced burden on States and issuers. compliance with data validation $399 per issuer. In addition, we estimate requirements by permitting the a qualified licensed provider E. ICRs Regarding Rate Increases submission of mental or behavioral (psychiatrist, at an hourly rate of Subject To Review (§ 154.200) health assessments for risk adjustment $192.52) will need 45 minutes to We are finalizing our proposal to data validation in the event that a prepare an abbreviated assessment and establish a 15 percent Federal default provider is subject to State privacy laws sign an attestation, for a total of $144 threshold for reasonableness review. We that prohibit the provider from per enrollee, or $5,776 per issuer. expect this to reduce burden for issuers providing HHS with a complete mental Therefore, for 40 patients, the total because Part II of the Rate Filing or behavioral health record. For risk burden per issuer for the provider to Justification (Consumer Justification adjustment data validation purposes, to obtain consent from each patient and Narrative) is only required for increases the extent permissible under applicable prepare an abbreviated assessment and that meet or exceed the threshold. In the Federal and State privacy laws, an signed attestation will be 40 hours and 2019 plan year, we estimate that the assessment should contain: (1) The approximately $6,174. The aggregated number of written justifications that enrollee’s name; (2) sex; (3) date of burden for the estimated 70 affected will be submitted will decrease by birth; (4) current status of all mental or issuers will be 2,800 hours and approximately 125 submissions. That behavioral health diagnoses; and (5) approximately $432,194. We are estimate is based on data from the 2018 dates of service. To submit a mental or revising the current information plan year. We reached this estimate by behavioral health assessment, an issuer collection approved under OMB Control counting the number of submissions

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with a product subject to review due to needs of their State and complies with determination or enroll in a SHOP QHP. an increase between 10 percent and 15 the regulatory flexibilities outlined Therefore, HHS estimates that it will percent. Specifically, CMS received 786 herein. cost an employer approximately $3 to submissions for the 2018 plan year; 579 Under the proposals being finalized in complete an eligibility determination. of those included a rate increase at or this rule several pieces of information Assuming that 6,000 employers will above 10 percent; while 454 of those currently being collected by a SHOP complete an eligibility determination, included a rate increase at or above 15 may no longer be collected by a SHOP, HHS estimates that the total annual percent, resulting in 125 submissions or, the way in which the information is burden will be approximately 500 falling between 10 percent and 15 collected may change. For example, hours, with an estimated total cost of percent. employers, employees, and agents and $17,400. This will result in a net burden We estimate that each written brokers may be required to provide the reduction of 11,500 hours and a net cost justification will require 1.5 hours for an information currently collected by a reduction of approximately $543,840 actuary (at a cost of $109.74 per hour) SHOP to an issuer for the purposes of annually. Under § 157.206(e)(1), to prepare and electronically transmit enrollment in a SHOP plan. A SHOP, employers will be responsible for the documentation. Therefore, the like the FF–SHOPs and SBE–FPs for submitting a new eligibility annual burden for issuers will be SHOP, however, will not be the entity determination or, submitting a notice of reduced by 187.5 hours, with an collecting the information and the withdrawal, in the event the group estimated annual savings of $20,576. Federal government thus will experienced a change that will impact As stated above, we estimate 125 experience a reduction in burden. the group’s eligibility to participate in a fewer submissions with rate increases Under the new regulatory flexibilities SHOP. Under § 157.206(e)(2), employers subject to review. Assuming that States being finalized and described will also be required to notify their QHP adopt the Federal default threshold, we throughout this rule, employers and issuer(s) of a determination of expect the number of State reviews will employees will no longer be required to ineligibility. Finally, employers will 102 decrease by 123 submissions. We visit a SHOP website in order to enroll also, under § 157.206(e)(3) be required estimate that each State review will in a SHOP plan and a SHOP will no to notify their issuers of their intent to require 38.5 hours of work by an actuary longer be required to have the capability no longer participate in a SHOP. While (at a cost of $80.82 per hour). Therefore, or the need to collect enrollment these proposals will require employers the State burden will decrease by information. Employers will however, to communicate with issuers in ways approximately 4,735.5 hours, with an be required to apply to the SHOP to they do not under current SHOP estimated annual savings of $382,723. obtain an eligibility determination, as enrollment practices, HHS does not We will revise our current burden described in § 155.710, at which point anticipate that these practices will estimate approved under OMB control the employer will be requested to increase the burden on employers as number 0938–1141: Rate Increase provide: (1) Employer name and address they, under current practice, must notify Disclosure and Review Reporting of employer’s locations; (2) Information the SHOP of changes in eligibility and Requirements, to reflect the reduced sufficient to confirm the employer is a termination. Although the policy in burden on issuers. small employer; (3) Employer § 155.716 imposes an information F. ICRs Regarding the Small Business Identification Number (EIN); and (4) collection requirement, the information Health Options Program (SHOP) Information sufficient to confirm that that will be collected is no different the employer is offering, at a minimum, from what is already approved under We are finalizing the proposals all full-time employees coverage in a OMB control number 0938–1193: Data granting additional flexibilities, QHP through a SHOP. Under current Collection to Support Eligibility effective on the effective date of this regulations, the employer provides, and Determinations and Enrollment for rule and applicable for plan years a SHOP collects, this information as part Small Businesses in the Small Business beginning on or after January 1, 2018, to of enrolling in a SHOP QHP through a Health Options, and therefore we are SHOPs, to qualified employers and SHOP. HHS previously estimated that not revising the information collection employees enrolling in SHOP plans, and an employer needed two hours to at this time. to participating QHP issuers and SHOP- complete the eligibility determination Employees, under § 155.716 will not registered agents and brokers in how when it was included as part of experience an increase in burden. Under they interact with a SHOP. Under the enrolling in a SHOP QHP and that 6,000 the policies described throughout this proposals being finalized throughout employers will complete an application final rule, employees will no longer be this document, SHOPs will no longer be annually to determine their eligibility required to visit an FF–SHOP website to required to provide enrollment, through a SHOP website. Based on these create an account, or, for any premium aggregation functions, and criteria, HHS estimated that the total application or enrollment purpose, but online enrollment functionality through annual burden for 6,000 employers was they may need to provide similar a SHOP website, and the FF–SHOPs and 12,000 hours, with a total annual cost of information to an agent or broker or SBE–FPs for SHOP, will no longer $561,240 to complete the SHOP issuer as a condition of enrollment into continue to perform these functions. application and eligibility a SHOP QHP. HHS previously estimated Instead, small groups will enroll in a determination process. With the new that 60,000 employees will complete an SHOP plan through a SHOP-registered regulatory flexibilities being granted to application annually, each spending agent or broker or through a SHOPs, HHS estimates that for each approximately one hour to complete an participating QHP issuer participating employer, an administrative assistant online application through an FF–SHOP in a SHOP. FF–SHOPs will follow the will need less than 5 minutes (at rate of website. The estimated annual burden approach as outlined in this final rule. $34.76 per hour) to complete the was 60,000 hours with an annual cost of SBEs will have the flexibility to operate required eligibility determination. $1,025,400. With the finalized their SHOP in a way that meets the Under the new flexibilities, employers flexibilities to a SHOP as described in will also no longer be required to create this rule, HHS predicts that the burden 102 For the 2018 plan year, CMS reviewed two submissions proposing a rate increase between 10 an account on an FF–SHOP website in on employees to complete an online percent and 15 percent. order to complete the eligibility application will shift as no application

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will be provided through a SHOP Alternative Benefit Plans, Eligibility document. We estimate that it costs website, but the information may be Notices, Fair Hearing and Appeal each State $264 to meet this reporting required by an agent or broker or an Processes, and Premiums and Cost requirement, with a total annual burden issuer in order for the employee to Sharing; Exchanges: Eligibility and for all 10 States of 40 hours and an complete an enrollment into a SHOP Enrollment. Issuers will be required to associated total cost of $2,642. QHP. The proposals described collect premiums, as premium Second, we require at § 156.111(e)(2) throughout this final rule will allow aggregation functions will no longer be that the State submit an actuarial agents and brokers and issuers to enroll provided by the SHOPs that take certification and associated actuarial consumers in SHOP plans using the advantage of the new flexibilities. HHS report of the methods and assumptions channels they are most familiar with, does not anticipate a significant increase when selecting options under potentially reducing the burden of of issuers’ burden in this scenario, as it § 156.111(a). Specifically, we are enrolling SHOP groups. This is not significantly different from their finalizing at § 156.111(b)(2)(i) and (ii) information collection is currently current operating practices. that a State’s EHB- benchmark plan approved under OMB control number must provide a scope of benefits equal G. ICRs Regarding Essential Health to, or greater than, to the extent any 0938–1194: Data Collection to Support Benefits (§ 156.111(e)) Eligibility Determinations and supplementation is required to provide Enrollment for Employees in the Small In the rule, we are finalizing at coverage within each EHB category at Business Health Options Program. § 156.111(e) to revise the collection of § 156.110(a), the scope of benefits Therefore, we are not revising the data for selection of States’ EHB- provided under a typical employer plan, information collection at this time. benchmark plans for plan years and that the State’s EHB-benchmark beginning on or after January 1, 2020. plan must not exceed the generosity of Sections 155.705, 155.715, 155.720, This proposal includes the the most generous among a set of 155.725, require SHOPs to generate documentation that States would be comparison plans. The actuarial certain notices. These notices may required to submit if the State chooses certification that is being collected include: (1) Notices of annual election to change its EHB-benchmark plan. For under this ICR is required to include an periods; (2) notices to employers of this purpose, we are amending the actuarial report that complies with employee coverage terminations; (3) currently approved information generally accepted actuarial principles notices of application inconsistencies; collection (OMB Control Number: 0938– and methodologies. This estimate (4) notices of appeal rights and 1174) to reflect the finalized policy in includes complying with all applicable instructions; (5) notices of employee this rule. Because § 156.111(e) is ASOPs. For example, ASOP 41 on and employer eligibility; (6) notices of replacing the current data collection actuarial communications includes employer withdrawal; (7) (in FF–SHOPs requirements at § 156.120, we are disclosure requirements, including only) notices to employees if a updating the current EHB-benchmark those that apply to the disclosure of dependent turns 26 and is no longer plan selection to account for the new information on the methods and eligible for dependent coverage; (8) regulation and any associated burden assumptions being used and ASOP 50 billing invoices, successful and with this requirement that falls on those contains information on determining unsuccessful payment confirmation States that choose to reselect their EHB- MV and AV. In accordance with ASOP notices; and (9) past due payment benchmark plan. Under the previous 41, we would expect that the actuarial notices. In prior guidance, HHS benchmark plan selection policy, 29 report is based on a data analysis that previously estimated costs for paper States selected one of the 10 base- is reflective of an appropriate notices in an FF–SHOP. In that estimate, benchmark plan options and 22 States population. The actuarial certification HHS assumed that 80 percent of defaulted. The previous benchmark plan for this requirement is provided in a enrollees requested electronic notices policy did not allow for States to make template and includes an attestation and 20 percent of enrollees requested an annual selection. The regulation that the standard actuarial practices paper notices. HHS estimated that allows States the opportunity to modify have been followed or that exceptions mailing paper notices costs a SHOP their EHB-benchmark plans annually. have been noted. The signing actuary is Exchange $0.53 per notice. HHS The regulation also does not require the required to be a Member of the determined that SHOPs sent State to respond to this ICR for any year American Academy of Actuaries. approximately 48,000 notices to for which they did not change their We estimate that an actuary, who is a enrollees when—(1) A dependent EHB-benchmark plan. As such, for member of the American Academy of became ineligible to remain on the plan; purposes of the new EHB-benchmark Actuaries, requires 18 hours (at a rate of (2) successful payment was processed; plan selection options finalized in this $80.82 per hour) on average for and (3) a payment was unsuccessful in rule, we estimate that 10 States would § 156.111(e)(2). This includes the the last year. Assuming that 20 percent choose to make a change to their EHB- certification and associated actuarial of enrollees will opt to receive paper benchmark plans in any given year report from an actuary to affirm, in notices instead of electronic (total of 30 States over 3 years within accordance with generally accepted notifications, HHS estimated that the authorization of this ICR) and actuarial principles and methodologies, approximately 9,600 notices will be respond to this ICR. that the State’s EHB-benchmark plan sent, costing FF–SHOPs approximately To select a new EHB-benchmark plan, provides a scope of benefits that is equal $5,088. Under the flexibilities being we require at § 156.111(e)(1) that the to, or greater than, to the extent any finalized, SHOPs will only be required State provide confirmation that the supplementation is required to provide to send notices of employer eligibility State’s EHB-benchmark plan selection coverage within an EHB category at and appeals. This cost will not directly complies with certain requirements, § 156.110(a), the scope of benefits be transferred to issuers as issuers may including those under § 156.111(a), (b), provided under a typical employer plan, already be required to send such notices and (c). To complete this requirement, and that the State’s EHB-benchmark per other applicable State and Federal we estimate that a financial examiner plan definition does not exceed the law. This collection is currently will require 4 hours (at a rate of $66.04 generosity of the most generous among approved under OMB control number per hour) to fill out, review, and the set of comparison plans. We are also 0938–1207: Essential Health Benefits in transmit a complete and accurate finalizing a document entitled Example

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of an Acceptable Methodology for State’s EHB-benchmark plan purpose. To collect the formulary drug Comparing Benefits of a State’s EHB- submission. list, the State is required to use the benchmark Plan Selection in We increased the estimated burden template provided by HHS and submit Accordance with 45 CFR 156.111(b)(2)(i) hours from 16 hours to 18 hours for the the formulary drug list as a list of and (ii) 103 that provides an example of actuary to complete the actuarial RxNorm Concept Unique Identifiers a method an actuary could use to certification and associated report in (RxCUIs). develop the actuarial certification and recognition of the extension of the Section 156.111(e)(4) requires the associated report at § 156.111(e)(2) for generosity standard and in recognition State to submit the documentation both the typical employer plan and that the definition of typical employer necessary to operationalize the State’s comparison plan standards. plan may require the actuary to EHB-benchmark plan. This reporting For these calculations, the actuary determine whether the typical employer requirement includes the EHB summary needs to conduct the appropriate plan meets MV requirements. We are file that is currently posted on CCIIO’s calculations to create and review an also increasing the estimated number of website, used as part of the QHP actuarial certification and associated States that need to respond to this certification process, and integrated into actuarial report, including minimal time section of the ICR from 7 to 10 since the HHS’s IT Build systems that feed into required for recordkeeping. The precise typical employer plan standard and the the data that is displayed on level of effort for the actuarial generosity standard applies to all State’s HealthCare.gov. While this document is certification and associated actuarial EHB-benchmark plan options at not a new document, the burden report under § 156.111(e)(2) will likely § 156.111(a). We estimate that each State associated with this document is new vary depending on the State’s approach incurs a burden of 19 hours with an for States. We estimate that it requires to its EHB-benchmark plan and this associated cost of $1,520.80 with a total a financial examiner 12 hours, on certification requirement. For example, annual burden for 10 States of 190 hours average, (at a rate of $66.04 per hour) to as described in the Example of an at associated total cost of $15,208. We create, review, and electronically submit Acceptable Methodology for Comparing did not receive comments on this a complete and accurate document to Benefits of a State’s EHB-benchmark specific estimate. HHS resulting in a burden of 12 hours Third, we require at § 156.111(e)(3) Plan Selection in Accordance with 45 and an associated cost of $792, with a each State to submit its proposed EHB- CFR 156.111(b)(2)(i) and (ii), to reduce total annual burden for all 10 States of benchmark plan documents. The level the burden of these standards, the 120 hours and an associated cost of of effort associated with this $7,925. actuary may want to consider using the requirement will depend on the State’s Under the previous policy, the burden same plan for both the generosity and selection of the EHB-benchmark plan estimates 226 respondents per year, for the typicality tests, provided that the options under the regulation at a total yearly burden total of 165 annual plan meets the standards at both § 156.111(a). However, for the purposes burden hours and a total annual § 156.111(b)(2)(i) and (ii). For example, of this estimate, we estimate that it associated cost of $8,094 to meet these the actuary may only need to do one requires a financial examiner (at a rate reporting requirements. Under the new plan comparison for the purposes of of $66.04 per hour) 12 hours on average policy related to EHB, we estimate that both of these certification requirements. to create, review, and electronically the total number of respondents will be Specifically, the actuary could use the transmit the State’s EHB-benchmark 10 per year, for a total yearly burden of same plan, such as the State’s EHB- plan document that accurately reflects 470 hours and an associated cost of benchmark plan used for the 2017 plan the benefits and limitations, including $33,699 to meet these reporting year. That plan would, by definition, be medical management requirements and requirements. The estimated burden a ‘‘Comparison Plan.’’ Because the a schedule of benefits, resulting in a associated with the changes represents State’s EHB-benchmark plan used for burden of 12 hours and an associated an increase of 305 hours (increase from the 2017 plan year would simply be one cost of $792, with a total annual burden 165 hours to 470 hours) and an annual of the State’s base-benchmark plans, for all 10 States of 120 hours and an costs increase of $25,605 (from $8,094 to supplemented as necessary under associated cost of $7,925. The burden $33,699) over the previously approved § 156.110, that plan also could be used for producing these documents is information collection (OMB Control for purposes of determining typicality, significantly higher than previous Number: 0938–1174). as a proposed State EHB-benchmark estimates because the previous data As part of the update to this OMB plan that was equal in scope of benefits collection generally only required the control number: 0938–1174, we also to the State’s EHB-benchmark plan used State (or issuer) to transmit the selected sought comment on requirements for for the 2017 plan year within each EHB benchmark plan document. In contrast, SADPs to submit voluntary reporting. category at § 156.110(a) would be equal in some cases, the § 156.111(a) may This collection includes data on to or greater in scope of benefits within result in the State needing to create a whether the issuer intends to offer each EHB category at § 156.110(a) than completely new document or SADP coverage, the anticipated the base-benchmark plan underlying the significantly modify the current Exchange market in which coverage will EHB-benchmark plan used for the 2017 document to represent the plan be offered, and the State and service plan year, to the extent of the required document. Additionally, this estimate of area in which the issuer offers coverage. supplementation. We estimate that a 12 hours also includes the burden The burden associated with meeting this financial examiner will require 1 hour necessary for a State selecting the option requirement includes the time and effort (at a rate of $66.04 per hour) to review, at § 156.111(e)(3) where the State is needed by the issuer to report on combine, and electronically transmit required to submit a formulary drug list whether it intends to offer SADP these documents to HHS, as part of a for the State’s EHB-benchmark plan in coverage. We estimate that it will take a format and manner specified by HHS. one half hour for a health insurance 103 Example of an Acceptable Methodology for Specifically, the burden for the State issuer to meet this reporting Comparing Benefits of a State’s EHB-benchmark selecting this option is also likely to requirement. We estimate that Plan Selection in Accordance with 45 CFR 156.111(b)(2)(i) and (ii) is available at https:// vary as the State could use an existing approximately 175 issuers will respond www.cms.gov/cciio/resources/regulations-and- formulary drug list or create its own to this data collection. Therefore, we guidance/index.html. formulary drug list separately for this anticipate that the reporting

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requirement will require a market changes to the MLR annual reporting for every individual market issuer at the research analyst one half-hour annually form and the associated burden. In product level (§ 158.321(d)(1)) and the to identify and submit the responsive addition, while we are not making reported and estimated MLRs records to HHS (at a rate of $67.90 per changes to § 158.162, pursuant to public (§ 158.321(d)(2)(ii) and (iii)) for issuers hour), for a total cost of $34 a year per comments, we intend to make a change with at least 1,000 enrollees, with total reporting entity. This will result in an to the MLR annual reporting form in enrollment (life-years and covered annual burden of 87.5 hours for all 175 order to collect the information on lives), premium, and total incurred issuers and a resulting estimated annual issuers’ employment taxes separately claims for only active individual market cost of $5,941. OMB approvals are from other taxes. We do not anticipate issuers, separately for five types of issued for 3 years; therefore, the that implementing this provision will individual market coverage: On- aggregate burden for 3 years will be significantly change the reporting Exchange plans, off-Exchange plans, approximately 263 hours with an burden either, as issuers already include grandfathered health plans as defined in associated cost of approximately this information on the reporting form, § 147.140, coverage that meets the $17,824. We did not receive comments and would simply have to include it on criteria for transitional policies outlined on these estimates. a different line on the form. The burden in applicable guidance, and non- Lastly, as part of the update to this related to this collection is currently grandfathered single risk pool coverage. OMB control number: 0938–1174, we approved under OMB control number States will not be required to provide are adding an information collection 0938–1164; Medical Loss Ratio Annual information on student health insurance request to this ICR to account for the Reports, MLR Notices, and coverage as defined in § 147.145 or finalized policy at § 156.115(b)(2)(ii) Recordkeeping Requirements. excepted benefits as defined in that allows the State the option to notify We are also amending subpart C to § 148.220. We expect these amendments HHS that the State will allow modify the data and narratives which a to result in a net reduction in burden on substitution between EHB categories of State must submit as part of the State’s States seeking an adjustment. We will benefits, beginning with the 2020 plan request for an adjustment to the MLR continue to collect data on total agents’ year. Specifically, § 156.115(b)(2)(ii) standard in the individual market for and broker’s commission expenses and will allow issuers to substitute benefits that State. There is no standardized net underwriting gain (proposed to be only when the State in which the plan application form associated with a redesignated from § 158.321(d)(2)(iv) will be offered permits such substitution State’s request, but each request must and (vi) to § 158.321(a)(3) and (4), and notifies HHS of its decision to allow contain certain data elements in order to substitution between categories. We receive consideration by the Secretary, respectively) for only active individual anticipate that States will notify HHS which are described in §§ 158.320– market issuers, but separately for the through the same means the States will 158.323, 158.340, 158.346, and 158.350. five types of coverage described above. notify HHS of an updated EHB- The burden related to the proposed We will also continue to collect benchmark plan selection under requirements was previously approved information on risk-based capital levels § 156.111 and we intend to provide a under OMB control number 0938–1114, (proposed to be redesignated from preformatted response for States to use Medical Loss Ratio (IFR) Information § 158.321(d)(2)(viii) to § 158.321(a)(5)) at to provide the notification to HHS. To Collection Requirements and the issuer level. While the amendments provide notification under Supporting Regulations; the approval will require more breakdown of the data § 156.115(b)(2)(ii), we estimate that it expired in 2014. We intend to reinstate than § 158.321 previously required, in most States there are more issuers with will require a financial examiner 1⁄2 this information collection, with hour, on average, (at a rate of $66.04 per modifications to reflect our finalized at least 1,000 enrollees than there are hour) to review and electronically revisions to subpart C of part 158. The active issuers in the individual market, submit a notification to HHS. proposed rule (82 FR 51052), published and consequently we expect that these Furthermore, we estimate that at most 5 on November 2, 2017, served as the 60- amendments will have no net impact on States will want to allow the flexibility day notice to afford the public an the burden. Additionally, we are for their issuers to substitute between opportunity to comment on this updating § 158.321(d)(2)(ix) to collect categories under § 156.115(b)(2)(ii). collection of information requirement. more specific information on issuer While this aspect of the ICR is not We are eliminating collection of the notices to the State of changes to subject to the PRA because we estimate following information from a State participation in the State’s individual that no more than 5 States will be requesting an adjustment: The State market, rather than focusing exclusively affected annually, we nonetheless MLR standard and formula for assessing on notices to exit the individual market. provide a total annual burden estimate compliance (§ 158.321(a)), its market We do not expect this amendment to for § 156.115(b)(2)(ii), which is 2.5 withdrawal requirements (§ 158.321(b)), have an appreciable impact on the hours and a total associated cost of and the mechanisms available to the burden. We are further eliminating the $165. State to provide consumers with options requirement that a State requesting an for alternate coverage (§ 158.321(c)); as adjustment provide information H. ICRs Regarding Medical Loss Ratio well as the net underwriting profit for explaining and justifying how its (§§ 158.170, 158.221, 158.320–323, the total business in the State and the proposed adjustment was determined 158.340, 158.346, and 158.350) after-tax profit and profit margin for the and estimating rebates that would be We are amending § 158.221 to allow individual market and total business in paid with and without an adjustment issuers the option to report quality the State (§ 158.321(d)(2)(vii)), and the (§ 158.322(a), (c), and (d)); as well as improvement activity expenses as a estimated rebate (§ 158.321(d)(2)(v)) of replacing what information a State must single fixed percentage of premium each issuer with at least 1,000 enrollees provide pursuant to § 158.322(b) with a amount beginning with the 2017 MLR in the State. We expect these requirement to explain how the reporting year (that is, for reports filed amendments to reduce the burden on adjustment would help stabilize the by July 31, 2018), and making States seeking an adjustment. We are State’s individual market. We expect conforming amendments to § 158.170. also replacing the requirement that a these amendments to reduce the burden. We do not anticipate that implementing State requesting an adjustment must Lastly, we have updated what this provision will require significant submit enrollment and premium data information a State must submit with a

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subsequent request for adjustment insurance commissioner 4 hours (at a information from health insurance pursuant to § 158.350. We do not expect rate of $116.90 per hour) to assemble issuers in their States, which could this amendment to change the burden. and review the various components of increase their burden. Some States may, Based on preliminary data analysis the application, resulting in a total if providing the requested information is and previous State requests for burden for each State of 140 hours with an undue burden, ask the Secretary to adjustments, we estimate that an associated cost of $10,626 per consider their application without some approximately 22 States will submit response, representing an estimated of the information elements. We applications in the first year. We total burden reduction of 45 hours per received a few comments that generally estimate that it will take approximately response. The documents will be questioned whether the burden on 140 hours on average for each State to submitted electronically at minimal States related to the information complete the application, including cost. We estimate that the total burden collection requirements prior to the gathering and analyzing data, for 22 States to submit a request for an finalized amendments may have been synthesizing information, and adjustment to the individual market overstated, but that did not specify the developing a proposal for an adjusted MLR standard will be 3,080 hours with basis for such concerns and did not MLR standard. Specifically, we assume an associated cost of approximately relate to the estimates for the revised that the application will take a financial $233,767, with an estimated net total information collection requirements. We analyst approximately 96 hours (at a reduction in burden of 620 hours. We also received one comment that agreed rate of $68.78 per hour), an actuary 6 recognize that this burden may vary with the estimates for the revised hours (at a rate of $80.82 per hour), a between States, as some States may have information collection. financial manager 10 hours (at a rate of better access to the required application $91.66 per hour), a lawyer 24 hours (at information elements, while other States I. Summary of Annual Burden Estimates a rate of $89.74 per hour), and the may have to seek some of the required for Final Requirements TABLE 12—FINAL ANNUAL RECORDKEEPING AND REPORTING REQUIREMENTS

Labor cost OMB control Burden per Total annual of Total cost Regulation section(s) No. Respondents Responses response burden reporting ($) (hours) (hours) ($)

§ 153.320 ...... 0938–1155 25 25 60 1,500 $121,880.00 $121,880.00 § 153.630(b)(6) ...... 0938–1155 70 2,800 1 2,800 432,194.00 432,194.00 § 156.111(e)(1) ...... 0938–1174 * 10 10 4 40 2,641.60 2,641.60 § 156.111(e)(2) ...... 0938–1174 * 10 10 19 190 15,208.00 15,208.00 § 156.111(e)(3) ...... 0938–1174 * 10 10 12 120 7,924.80 7,924.80 § 156.111(e)(4) ...... 0938–1174 * 10 10 12 120 7,924.80 7,924.80 § 156.115(b)(2)(ii) ...... 0938–1174 * 5 5 0.5 2.5 165.10 165.10 § 156.150 ...... 0938–1174 175 175 0.5 87.5 5,941.25 5,941.25 §§ 158.320–323, 158.340, 158.346–350 ...... 0938–1114 22 22 140 3,080 233,766.72 233,766.72

Total ...... 302 3,067 ...... 7,940 827,646.27 827,646.27 * Denote the same entities. For purposes of calculating the total, the value is used only once. Note: There are no capital/maintenance costs associated with the information collection requirements contained in this rule; therefore, we have removed the associ- ated column from Table 12.

J. Submission of PRA-Related V. Regulatory Impact Analysis Health Options Program; and FFE and Comments SBE–FP user fees. A. Statement of Need We have submitted a copy of this final B. Overall Impact rule to OMB for its review of the rule’s This rule finalizes standards related to information collection and the risk adjustment program for the We have examined the impacts of this rule as required by Executive Order recordkeeping requirements. These 2019 benefit year, as well as certain 12866 on Regulatory Planning and requirements are not effective until they modifications that will promote State Review (September 30, 1993), Executive have been approved by the OMB. flexibility and control over their Order 13563 on Improving Regulation To obtain copies of the supporting insurance markets, reduce burden on statement and any related forms for the and Regulatory Review (January 18, stakeholders, and protect consumers 2011), the Regulatory Flexibility Act final collections discussed above, please from increases in premiums due to visit CMS’s website at (RFA) (September 19, 1980, Pub. L. 96– issuer uncertainty. The Premium 354), section 202 of the Unfunded www.cms.hhs.gov/ Stabilization Rule and previous PaperworkReductionActof1995, or call Mandates Reform Act of 1995 (March Payment Notices provided detail on the the Reports Clearance Office at 410– 22, 1995, Pub. L. 104–4), Executive implementation of the risk adjustment 786–1326. Order 13132 on Federalism (August 4, We invite public comments on these program, including the specific 1999), and the Congressional Review information collection requirements. If parameters applicable for the 2014, Act (5 U.S.C. 804(2)), and Executive you wish to comment, please submit 2015, 2016, 2017, and 2018 benefit Order 13771 on Reducing Regulation your comments electronically as years. This rule finalizes additional and Controlling Regulatory Costs specified in the ADDRESSES section of standards related to EHBs; cost-sharing (January 30, 2017). this final rule and identify the rule parameters; QHP certification; the Executive Orders 12866 and 13563 (CMS–9930–F), the ICR’s CFR citation, Exchanges, including terminations, direct agencies to assess all costs and CMS ID number, and OMB control exemptions, eligibility and enrollment; benefits of available regulatory number. AV for stand-alone dental plans; MEC; alternatives and, if regulation is ICR-related comments are due May the rate review program; the medical necessary, to select regulatory 17, 2018. loss ratio program; the Small Business approaches that maximize net benefits

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(including potential economic, increase access to affordable health group health insurance markets and in environmental, public health and safety coverage. Although there is some an Exchange. We are unable to quantify effects, distributive impacts, and uncertainty regarding the net effect on certain benefits of this final rule—such equity). Executive Order 13563 enrollment and premiums, we as any reduction in burden related to emphasizes the importance of anticipate that the provisions of this changes in the timing related to State quantifying both costs and benefits, of final rule will help further HHS’s goal deadlines for submission of rate filings reducing costs, of harmonizing rules, of ensuring that all consumers have from issuers that only offer non-QHPs; and of promoting flexibility. A access to quality, affordable health care; increased flexibility for Exchanges regulatory impact analysis (RIA) must that markets are stable; and that related to the removal of certain be prepared for rules with economically Exchanges operate smoothly. requirements for Navigator programs significant effects ($100 million or more Although it is difficult to discuss the and non-Navigator assistance personnel in any 1 year). wide-ranging effects of these provisions entities; increased access to the direct OMB has determined that this final in isolation, the overarching goal of the enrollment pathway stemming from rule is ‘‘economically significant’’ premium stabilization, market permitting a third-party entity to within the meaning of section 3(f)(1) of standards, and Exchange-related conduct operational readiness reviews Executive Order 12866, because it is provisions and policies in the PPACA is for agents, brokers, and issuers; benefits likely to have an annual effect of $100 to make affordable health insurance to Exchanges related to proposed million in any 1 year. Accordingly, we available to individuals who do not simplifications of verification have prepared an RIA that presents the have access to affordable employer- requirements; benefits to consumers, costs and benefits of this final rule. sponsored coverage or government- issuers or Exchanges related to the Section 3(f) of Executive Order 12866 sponsored coverage. The provisions changes related to the special defines a ‘‘significant regulatory action’’ within this final rule are integral to the enrollment periods; increased flexibility as an action that is likely to result in a goal of expanding coverage. For for States relating to the proposals rule—(1) Having an annual effect on the example, the risk adjustment program regarding the SHOP enrollment process; economy of $100 million or more in any helps prevent risk selection and and potential decreases in premiums to 1 year, or adversely and materially decrease the risk of financial loss that consumers related to removing actuarial affecting a sector of the economy, health insurance issuers might value standards for SADPs—and certain productivity, competition, jobs, the otherwise expect in 2019. environment, public health or safety, or HHS anticipates that the provisions of costs—such as the costs incurred by State, local or tribal governments or this final rule will help further the small employers, agents and brokers, communities (also referred to as Department’s goal of ensuring that all and potential increases in out-of-pocket ‘‘economically significant’’); (2) creating consumers have access to quality and costs to consumers related to removing a serious inconsistency or otherwise affordable health care and are able to actuarial value standards for SADPs; interfering with an action taken or make informed choices, that Exchanges and costs to issuers, brokers, agents, and planned by another agency; (3) operate smoothly, that the risk employers related to changes in SHOP materially altering the budgetary adjustment program works as intended, enrollment procedures. The effects in impacts of entitlement grants, user fees, and that States have more control and Table 13 reflect qualitative impacts and or loan programs or the rights and flexibility over EHBs, QHP certification estimated direct monetary costs and obligations of recipients thereof; or (4) and the operation and establishment of transfers resulting from the provisions raising novel legal or policy issues Exchanges. Affected entities such as of this final rule for health insurance arising out of legal mandates, the QHP issuers will incur costs to comply issuers. The annualized monetized costs President’s priorities, or the principles with the proposed provisions, for described in Table 13 reflect direct set forth in the Executive Order. A example, those related to the functions administrative costs to health insurance regulatory impact analysis (RIA) must of a SHOP; including calculating the issuers as a result of the finalized be prepared for major rules with minimum participation rate at the provisions, and include administrative economically significant effects ($100 employer level and processing SHOP costs associated with States requesting a million or more in any 1 year), and a enrollments for employers and reduction in risk adjustment transfers ‘‘significant’’ regulatory action is subject employees; and States will incur costs if for the State’s individual, small group or to review by OMB. HHS has concluded they select a new EHB-benchmark plan merged market, the reduction in costs that this rule is likely to have economic under the new regulations. In relating to issuers and States having to impacts of $100 million or more in at accordance with Executive Order 12866, no longer submit rate increases for least 1 year, and therefore, meets the HHS believes that the benefits of this student health insurance plans to HHS, definition of ‘‘significant rule’’ under regulatory action justify the costs. and costs associated with States seeking Executive Order 12866. Therefore, HHS an adjustment to the MLR standard in has provided an assessment of the C. Impact Estimates of the Payment the State’s individual market that are potential costs, benefits, and transfers Notice Provisions and Accounting Table estimated in the Collection of associated with this rule. In accordance with OMB Circular A– Information section of this final rule. The provisions in this final rule aim 4, Table 13 depicts an accounting The annual monetized transfers to improve the health and stability of statement summarizing HHS’s described in Table 13 include costs the Exchanges, and to provide States assessment of the benefits, costs, and associated with SBE–FP user fees, the with additional flexibility and control transfers associated with this regulatory risk adjustment user fee paid to HHS by over their insurance markets. They will action. issuers, and reductions in rebate reduce regulatory burden, and reduce This final rule implements standards payments from issuers to consumers administrative costs for issuers and for programs that will have numerous related to QIA and MLR adjustments. States, and will lower net premiums for effects, including providing consumers We are finalizing a risk adjustment user consumers. Through the reduction in with access to affordable health fee to collect $1.80 per enrollee per year financial uncertainty for issuers and insurance coverage, reducing the impact from risk adjustment issuers to operate increased affordability for consumers, of adverse selection, and stabilizing the risk adjustment program on behalf of these provisions are expected to premiums in the individual and small States, which we expect to cost

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approximately $40 million, similar to which together results in a slightly FFE functions for the 2019 benefit year the $40 million in contract costs higher risk adjustment user fee rate than will be similar to the updated costs for expected for benefit year 2018 when we the benefit year 2018 rate. As we the 2018 benefit year, and the user fee established a $1.68 per-enrollee-per-year generally expect similar risk adjustment rate will yield the same amount of risk adjustment user fee rate. As in user fee costs as the 2018 benefit year, transfers from FFE issuers to the Federal 2018, the risk adjustment user fee there are no changes to the risk government as in the prior benefit year. contract costs for 2019 include adjustment user fee transfers to include Therefore, there are no changes to the additional costs for risk adjustment data in Table 13. Also, we expect a decrease FFE user fee transfers to include in validation; however, we expect reduced in FFE user fee collections necessary as Table 13. We also proposed an SBE–FP costs related to issuer outreach and we estimate lower contract costs due to user fee rate to be set at 3.0 percent for education as issuers gain familiarity streamlining of FFE operations and an benefit year 2019, which is higher than with the risk adjustment program, and increase in premiums but also lower the 2.0 percent SBE–FP user fee rate we lower enrollment in risk adjustment enrollment, resulting in a proposed user finalized for the 2018 benefit year. In covered QHPs, and additional costs to fee rate of 3.5 percent for 2019, which this rule, we also finalized a proposal to include administrative and personnel is the same as the FFE user fee rate cease charging user fees on SHOP costs related to the risk adjustment established for 2014 through 2018 issuers offering plans through an FFE or program that were inadvertently benefit years. However, the decrease in SBE–FP starting for plan years excluded in prior years’ cost estimation, user fee collections required to support beginning on and after January 1, 2018.

TABLE 13—ACCOUNTING TABLE

Benefits:

Qualitative: • Greater market stability resulting from improvements to the risk adjustment methodology. • Potential increased enrollment in the individual market stemming from lower premiums, leading to improved access to health care for the previously uninsured, especially individuals with medical conditions, which will result in improved health and protection from the risk of catastrophic medical expenditures.a • More informed Exchange QHP certification decisions. • Increased coverage options for small businesses and employees with less adverse selection. • Cost savings to consumers and issuers due to reduced administrative costs for issuers. • Potential decreases in premiums associated with States opting to select a new EHB-benchmark plan. • Reduced burden to Exchanges, due to the removal of 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, and the removal of the requirement that each Navigator (and each non-Navigator entity subject to § 155.215) maintain a physical presence in the Exchange service area. • Reduced costs and burden and increased flexibility to agents and brokers performing direct enrollment and their third-party auditors due to the removal of the requirement to obtain HHS approval to perform reviews. • Reduction in administrative costs to issuers due to the removal of the meaningful difference standard, and final changes to the SHOPs.

Estimate Year Discount rate Period Costs: (million) dollar (percent) covered

Annualized Monetized ($/year) ...... ¥$26.71 2016 7 2018–2022

¥25.54 2016 3 2018–2022

Quantitative: • Costs incurred by issuers and States to comply with provisions in the final rule as detailed in the Collection of Information Requirements section, taking into account the reduction in burden and costs for issuers and States due to the elimination of the requirement to submit rate reviews to HHS for student health insurance coverage b and increase in the rate review threshold and the reduction in burden and costs to States related to the requests for adjustment to the MLR standard in their individual markets. • Reduction in costs to issuers due to changes to the requirements for risk adjustment data validation. • Reduction in potential costs to Exchanges since they will no longer be required to conduct sampling as a verification process for eligibility for employer-based insurance starting plan year 2018, and can instead conduct an alternate process through plan year 2019. • Costs incurred by Exchanges to implement new verification requirements for income inconsistencies. • Regulatory familiarization costs.

Qualitative: • Costs due to increases in providing medical services (if health insurance enrollment increases). • Costs to issuers of redesigning SADPs to account for the removal of actuarial value standards for SADPs. • Potential increases in out of pocket costs associated with States opting to select a new EHB-benchmark plan. • Potential increases in out of pocket costs and loss of benefits and services associated with substitution between EHB categories.c • Potential increase in consumer burden related to plan comparisons in those States allowing substitution between EHB categories.

Transfers: Estimate Year Discount rate Period (million) dollar (percent) covered

Federal Annualized Monetized ($/year) ...... $17.8 2017 7 2018–2022

18.6 2017 3 2018–2022

Other Annualized Monetized ($/year) ...... 87 2017 7 2018–2022

87 2017 3 2018–2022

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Estimate Year Discount rate Period Costs: (million) dollar (percent) covered

Quantitative: • Transfer from health insurance issuers to the Federal government of $40 million as risk adjustment user fees for 2022 (the same amount as previously estimated for 2018–2021). • Increased transfers from SBE–FP issuers to the Federal government of $20 million due to increase in user fee rate from 2.0 set in 2018 to 3.0 percent final for 2019. • Decrease in user fee transfers from SHOP issuers offering plans through an FF–SHOP or SBE–FP for SHOP to the Federal government of approximately $6 million in 2019. • Reduced transfers to consumers from health insurance issuers in the form of rebates of $75 million to $87 million due to final amend- ments to the medical loss ratio requirements.d

Qualitative: • Lower premium rates in the individual market due to the improved risk profile of the insured, competition, and pooling. • A decrease in the premiums and risk adjustment transfers in the individual, small group or merged markets as a result of potential State requests to reduce risk adjustment transfers for the State’s individual, small group or merged market. • Potential increases in premiums associated with adjustments to MLR. • Potential decreases in premiums associated with removal of AV standards for SADPs. • Potential increases in out of pocket costs associated with removal of AV standards for SADPs. a Removal of AV standards for SADPs may reduce enrollment due to reductions in coverage and potential higher out-of-pocket costs. b The reduction in burden and costs associated with student health insurance could result in lower premiums. c Some consumers may experience an increase in services and benefits. The net result is uncertain. d For the purpose of calculating total transfers, the upper bound was used.

This RIA expands upon the impact budget from fiscal years 2018 through accounting statement for this final rule analyses of previous rules and utilizes 2022, with the additional, societal (Table 13). the Congressional Budget Office’s (CBO) effects of this final rule discussed in this In addition to utilizing CBO analysis of the PPACA’s impact on RIA. We do not expect the provisions of projections, HHS conducted an internal Federal spending, revenue collection, this final rule to significantly alter analysis of the effects of its regulations and insurance enrollment. The PPACA CBO’s estimates of the budget impact of on enrollment and premiums. Based on transitional reinsurance program and the premium stabilization programs that these internal analyses, we anticipate temporary risk corridors program end are described in Table 14. We note that that the quantitative effects of the after the benefit year 2016. Therefore, transfers associated with the risk provisions proposed in this rule are the costs associated with those programs adjustment program were previously consistent with our previous estimates are not included in Tables 14 or 15 for estimated in the Premium Stabilization in the 2018 Payment Notice for the fiscal years 2019–2022. Table 14 Rule; therefore, to avoid double- impacts associated with the APTC, the summarizes the effects of the risk premium stabilization programs, and counting, we do not include them in the adjustment program on the Federal FFE user fee requirements. TABLE 14—ESTIMATED FEDERAL GOVERNMENT OUTLAYS AND RECEIPTS FOR THE RISK ADJUSTMENT, REINSURANCE, AND RISK CORRIDORS PROGRAMS FROM FISCAL YEAR 2018–2022 [In billions of dollars]

Year 2018 2019 2020 2021 2022 2018–2022

Risk Adjustment, Reinsurance, and Risk Corridors Program Payments ...... 5 5 5 6 6 27 Risk Adjustment, Reinsurance, and Risk Corridors Program Collections * ...... 5 5 6 6 6 28 Note 1: Risk adjustment program payments and receipts lag by one quarter. Receipt will fully offset payments over time. Note 2: The CBO score reflects an additional $1 million in payments in FY 2018 that are collected in prior fiscal years. CBO does not expect a shortfall in these programs. Source: Congressional Budget Office. Federal Subsidies for Health Insurance Coverage for People Under Age 65: 2017 to 2027 Table 2. September 2017. Avail- able at https://www.cbo.gov/system/files/115th-congress-2017-2018/reports/53091-fshic.pdf.

1. Risk Adjustment on its behalf. As described in the 2014 adjustment issuer outreach and through 2018 Payment Notices, if HHS education and lower enrollment in risk The risk adjustment program is a operates risk adjustment on behalf of a adjustment covered QHPs, and includes permanent program created by the State, it will fund its risk adjustment administrative and personnel cost PPACA that transfers funds from lower program operations by assessing a risk related to the risk adjustment program, risk, non-grandfathered plans to higher adjustment user fee on issuers of risk resulting in a slightly higher user fee risk, non-grandfathered plans in the adjustment covered plans. For the 2019 rate for 2019 than the 2018 benefit year individual and small group markets, benefit year, we estimate that the total rate. inside and outside the Exchanges. We cost for HHS to operate the risk We believe that the approach of established standards for the adjustment program on behalf of States blending the coefficients calculated administration of the risk adjustment for 2019 will be approximately $40 from the 2016 benefit year enrollee-level program, in subparts D and G of part million, and that the risk adjustment EDGE data with 2014 and 2015 153 in Title 45 of the CFR. user fee would be approximately $1.80 MarketScan® data finalized in this rule A State approved or conditionally per enrollee per year. This user fee will provide stability within the risk approved by the Secretary to operate an reflects costs to support the risk adjustment program and minimize Exchange may establish a risk adjustment data validation process in volatility in changes to risk scores from adjustment program, or have HHS do so 2019, lower costs related to risk the 2018 benefit year to the 2019 benefit

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year due to differences in the datasets’ Therefore, this change will not have a Raising the Federal default review underlying populations. significant impact on costs or burden for threshold from 10 percent to 15 percent We are finalizing the provision for affected issuers. will reduce administrative burden for States to request a reduction in risk We are finalizing an amendment to issuers and States while continuing to adjustment transfers in the individual, § 153.630(b)(6) to state that a qualified provide the Secretary and the States small group or merged market. We provider licensed to diagnose mental with the information necessary to expect this policy will reduce transfers illness that is prohibited by State effectively carry out their proportional to the percent by which the privacy laws from furnishing a complete responsibilities to monitor rate increases States seek to reduce the transfers to medical record for data validation may inside and outside of Exchanges. As account for State-specific market rules furnish a signed mental or behavioral discussed previously in the Collection or relevant factors without the necessity health assessment that providers of Information Requirements section, for States to undertake operation of their routinely prepare along with the issuer burden will decrease by an own risk adjustment program. However, required attestation. For risk adjustment estimated $20,576 and the State burden because the risk adjustment program is data validation purposes, a mental or will decrease by an estimated $519,674 budget neutral, any State decision to behavioral health assessment should, to annually. Given that only one rate filing request a reduction in the risk the extent permissible under applicable subject to review over the last 4 years adjustment transfers will have no net State and Federal privacy laws, contain: in the 10 to 15 percent rate increase impact on risk adjustment transfers. (i) The enrollee’s name; (ii) sex; (iii) date range was determined to be of birth; (iv) current status of all mental 2. Risk Adjustment Data Validation unreasonable, we feel this is a or behavioral health diagnoses; and (v) reasonable tradeoff for the potential We are finalizing several changes to dates of service. The burden associated burden savings. the requirements for risk adjustment with this requirement has been data validation that overall would discussed previously in the Collection 4. Additional Required Benefits reduce regulatory burden and costs for of Information Requirements section. (§ 155.170) issuers of risk adjustment covered plans. We are finalizing an amendment to We are extending the applicability of HHS believes that adjusting issuers’ risk § 153.630(b)(9) to state that, if an issuer the policies governing State-required adjustment risk scores only when an of a risk adjustment covered plan (1) benefits at § 155.170 to the policies issuer’s failure rate for a group of HCCs fails to engage an initial validation finalized at § 156.111, which provide is statistically different from the auditor; (2) fails to submit the results of States with new options for selecting weighted mean failure rate for that an initial validation audit to HHS; (3) their EHB-benchmark plans beginning group of HCCs for all issuers that engages in misconduct or substantial for the 2019 plan year. Specifically, submitted initial validation audits will non-compliance with the risk under any of the three EHB-benchmark help market stability by increasing adjustment data validation standards plan selection options, or if the State issuers’ ability to predict risk and requirements applicable to issuers defaults to its current EHB-benchmark adjustment transfers and liquidity of risk adjustment covered plans; or (4) plan, the policies regarding State- needs. We anticipate that many issuers intentionally or recklessly misrepresents required benefits will continue to apply. required to participate in risk or falsifies information that it furnishes Because these policies continue to be in adjustment data validation will not have to HHS, HHS may impose CMPs in effect, we do not anticipate any their risk scores adjusted, based on our accordance with the procedures set additional burden on States or issuers. analysis of error rates in the Medicare forth in § 156.805(b) through (e). 5. Standards for Navigators and Certain risk adjustment data validation program. Because risk adjustment data validation Non-Navigator Assistance Personnel We anticipate that the post-transfer has thus far operated as a pilot program, (§§ 155.210 and 155.215) adjustment of risk adjustment transfers we cannot estimate the number of for issuers that exited a State market issuers that will be subject to CMPs. We amended § 155.210(c)(2) to will result in transfer adjustments for a However, we do not expect that a remove the requirements that each small subset of issuers that previously significant number of issuers will Exchange must have at least two would not have had their transfers engage in the extreme misconduct Navigator entities and that one of these adjusted, but HHS does not expect this required to warrant a CMP under this entities must be a community and policy to increase burden for these amended regulation. consumer-focused nonprofit group. We issuers, especially in light of the revised also amended §§ 155.210(e)(7) and 3. Rate Review payment adjustments for error rates 155.215(h) to remove the requirements policy finalized in this rule. We are amending § 154.103 to exclude that Navigators and non-Navigator HHS estimates that not requiring student health insurance coverage assistance personnel entities subject to issuers that have 500 or fewer billable effective on or after July 1, 2018 from those regulations maintain a physical member months Statewide to conduct the Federal rate review requirements. presence in the Exchange service area. an initial validation audit beginning in This will reduce burden related to rate These amendments to § 155.210(c)(2) the 2017 benefit year will reduce the review submission and review for will reduce the burden on Exchanges to administrative burden and costs on issuers and States. In addition, have at least two separate Navigator those issuers. The reduction in burden providing States with more flexibility entities, and as a result, Exchanges may and costs related to this ICR has been regarding timing of submission of rate be able to reduce funding amounts discussed previously in the Collection filing justification from issuers that offer while still meeting program of Information Requirements section. non-QHPs only, and reducing the requirements. Removing these Under the change to the sampling advance notification requirement for requirements will help promote methodology finalized in this rule, rate increase announcements, will flexibility and autonomy for each issuers that were the sole issuer in a risk reduce regulatory burden for issuers and Exchange to structure its Navigator pool will still need to provide a sample States. The reduction in burden and program, and to award grant funding to for data validation, but the sample will costs related to ICRs have been the number and type of entities that will not include enrollees from the risk pool discussed previously in the Collection be most effective and efficient for that where they were the sole issuer. of Information Requirements section. specific Exchange service area. To the

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extent that Exchanges take advantage of additional technical details regarding relieve Exchanges from the burden of these flexibilities, consumers may have compliance with the specific investing resources to conduct sampling fewer options of Navigator grantees and requirements under these rules in when the FFEs’ study of a sampling-like may not have access to a Navigator guidance in the future. process found that this method of grantee or a non-Navigator assistance verification may not be cost-effective for 7. Eligibility Standards (§ 155.305) personnel entity that maintains a some Exchanges at this time. We physical presence in the Exchange The requirement in § 155.305(f)(4)(ii) estimate the burden associated with service area. Exchanges continue to that the Exchange must send direct sampling based in part on the have the flexibility to fund more than notification to the tax filer before alternative process used for the FFEs. one Navigator grantee and State denying eligibility for APTC to HHS incurred approximately $750,000 Exchanges continue to have the consumers who fail to file and reconcile in costs to design and operationalize flexibility to require that Navigators went into effect in mid-January 2017; this study and the study indicated that maintain a physical presence in the therefore, it did not impact operations $353,581 of APTC was potentially Exchange service area. for the 2017 open enrollment period, incorrectly granted to individuals who which was nearly over then. At that inaccurately attested to their eligibility 6. Standards for Third-Party Entities To point in time, for the FFE, the Perform Audits of Agents, Brokers, and for or enrollment in a qualifying eligible household contacts for non-filers had employer-sponsored plan. We placed Issuers Participating in Direct been notified of their tax filer’s non- Enrollment (§ 155.221) calls to employers to verify 15,125 cases compliance, and APTC had been but were only able to verify 1,948 cases. The final regulations replace the discontinued at auto re-enrollment for A large number of employers either requirement that an HHS-approved those who did not file a Federal income could not be reached or were unable to third party perform audits of agents and tax return according to IRS data or verify a consumer’s information, brokers participating in direct inform the FFE that they had filed a resulting in a verification rate of enrollment and use their own internet Federal tax return and reconciled past approximately 13 percent. The sample- website for QHP selection or to APTC. Requiring the Exchange to deny size involved in the 2016 study did not complete the Exchange eligibility APTC for failure to file and reconcile represent a statistically significant application to instead permit an agent, even in the absence of ‘‘direct sample of the target population and did broker or issuer to select a third-party notification . . . to the tax filer’’ is not fulfill all regulatory requirements for entity that meets HHS requirements to unlikely to add new burden since sampling under paragraph (d)(4)(i) of conduct an annual operational readiness Exchanges have not yet implemented § 155.320. review prior to participating in direct § 155.305(f)(4)(ii). We do not believe enrollment. HHS anticipates this that Exchanges have built an FTI- Taking additional costs into approach will reduce the regulatory compliant noticing infrastructure since account—namely, the cost of sending burden on agents, brokers, and issuers the publication of the final rule notices to employees as required under participating in direct enrollment. HHS establishing § 155.305(f)(4)(ii) that they paragraph (d)(4)(i)(A), the cost of also anticipates these changes will will need to dismantle. However, building the infrastructure and reduce the burden on third-party removing § 155.305(f)(4)(ii) avoids implementing the first year of auditors performing reviews under significant costs for Exchanges that, as operationalizing this process, and the § 155.221, as those entities will no discussed above, no longer must build cost of expanding the number of cases longer be required to obtain HHS the infrastructure necessary to directly to a statistically significant sample size approval to perform the reviews. notify tax filers about their tax filing of approximately 1 million cases—we Furthermore, we believe this policy will status while protecting FTI. estimate that the overall cost of expand the available number of implementing sampling would be qualified third-party auditors by 8. Verification Requirements (155.320) approximately $8 million for the FFE, removing any time and operational This rule amends § 155.320(c)(3)(iii) and between $2 million and $7 million restrictions imposed by the HHS pre- to create annual income data matching for other Exchanges, depending on their approval requirement, which will issues when applicants attest to income enrollment volume and existing provide more flexibility to agents, above 100 percent FPL, but trusted data infrastructure. Therefore, we estimate brokers, or issuers as they complete sources show income below 100 percent that the average per-Exchange cost of operational readiness reviews. FPL. We estimate that each SBE will implementing sampling that resembles Additionally, we believe this will incur one-time costs of approximately the FFE’s approach would be enable more agents, brokers and issuers $450,000 to complete the necessary approximately $4.5 million for a total to demonstrate operational readiness by system changes to implement this cost to SBEs of $54 million, when reducing the burden on HHS for policy. For 12 SBEs, the estimated total assuming 12 SBEs (operating in 11 conducting reviews, expediting the cost will be $5.4 million. This estimate States and the District of Columbia). ability of these entities to demonstrate does not take into account the ongoing This cost estimate does not, however, readiness, and increasing the feasibility operational expenses of processing data take into account the cost of notifying of approval for use of innovative matching issues from this new consumers when the information pathways, thereby creating more requirement. Ongoing operational costs provided by their employer changes opportunities for enrollment in QHP will be dependent on the Exchange’s their eligibility determination described coverage for consumers, potentially number of applicants with income under paragraph (d)(4)(i)(E), the cost of increasing enrollment. HHS anticipates inconsistencies and the threshold for providing employees consumer support that some of the burden will be lessened setting a data matching issue. that may be needed to understand by the fact that many agents, brokers, or This final rule will amend notices and any change in eligibility, or issuers already have the established § 155.320(d)(4) to allow an Exchange to the cost of ending those consumers’ privacy and security controls, and may conduct an HHS-approved alternative APTCs, when necessary. This estimate have existing relationships with process instead of sampling, as provided also does not account for the unique auditors that could be leveraged for under paragraph (d)(4)(ii) through operating costs of each Exchange, the these reviews. We intend to provide benefit year 2019. We believe this will change to paragraph (d)(4) to allow

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Exchanges to continue to use an month after the date of their qualifying available to dependents who are newly alternate process through benefit year event may need to make updates so that enrolling in a plan with a QHP enrollee 2019, and the flexibility afforded consumers instead have the option to through a special enrollment period will Exchanges described at § 155.315(h) and elect that their coverage take effect the increase the burden on States, which referenced in § 155.320(a)(2). first of the month after their date of plan will be required to do a system build to We believe this finalized change will selection. However, as discussed in the align their systems with this change. We lessen the financial and technical preamble, we believe that this burden appreciate these concerns raised by burdens on Exchanges under current will be limited, and mitigated due to the States, but do not anticipate that this regulation and allow Exchanges to fact that offering a ‘‘first of the month’’ change will add significant additional conduct an alternative process to coverage effective date is optional for burden on top of the system builds sampling under paragraph (d)(4) as Exchanges, permitting a delayed rollout States are already doing. The intent of approaches to sampling are refined and if necessary. this policy change is to streamline the data bases are compiled over time. We Additionally, amending paragraph plan option rules for dependents who sought comment on the reduction in (a)(5) to exempt qualified individuals are newly enrolling in coverage with burden associated with extending the from the prior coverage requirement that enrollees through a special enrollment option to allow Exchanges to fulfill applies to certain special enrollment period and so we anticipate that any verification requirements by conducting periods if they lived in a service area additional burden incurred to amend an HHS-approved alternative process to where no qualified health plan was Exchange system functionality will be sampling through plan year 2019. We available through the Exchange for 1 or offset by the efficiencies gained in did not receive any comments on the more days during the 60 days preceding streamlining Exchange eligibility rules. reduction of burden associated with our the qualifying event or during their most proposed change. recent preceding enrollment period, as 10. Effective Dates for Terminations specified in §§ 155.410 and 155.420, (§ 155.430) 9. Special Enrollment Periods may provide a pathway to coverage for Permitting all enrollee-initiated (§ 155.420) a small group of individuals, and is not terminations to become effective on the We do not anticipate that the anticipated to impact the Exchange risk date of enrollee request or a later date revisions to § 155.420 will create pool. It may generate burden on of their choosing, and removing the significant costs or burdens because Exchanges due to required technical and special termination effective date for several changes will simplify special operational updates should it become newly eligible Medicaid/CHIP/BHP enrollment period policy, and we also necessary to implement, but we consumers streamlines termination believe that they will generate some anticipate that this burden will be effective dates for Exchanges and benefit in the form of added efficiency mitigated by the small size of the reduces complication and confusion for Exchanges and improvements in affected group and by practices that are among consumers and issuers. some consumers’ ability to maintain already in place in many Exchanges to Exchanges and issuers were not continuous coverage and understand verify eligibility for special enrollment expected to incur new costs by aligning their coverage options. periods. Additionally, Exchanges these termination dates, as Exchanges For example, the amendment to already exempt qualified individuals and issuers are well acquainted with paragraph (d)(1)(iii) allows Exchanges to from the prior coverage requirement same-day termination transactions. provide similar treatment to all women who may not previously have had However, we received comments from losing non-MEC pregnancy-related access to QHP coverage through an some SBEs that their systems would not coverage, which enables a more Exchange, including those who were allow for mid-month terminations. streamlined special enrollment period previously living in a foreign country or Therefore, we are not requiring the eligibility process. United States territory and Indians as alignment of termination effective dates Additionally, the revisions in defined by section 4 of the Indian as proposed, but rather are providing paragraph (b)(2)(i) align regulatory Health Care Improvement Act. Exchanges flexibility to choose whether policy for special enrollment periods Therefore, we do not believe that adding to implement the changes that were based on a court order with other an additional small population to this proposed. Operationalizing the aligned similar special enrollment period types, exemption will create additional costs termination dates may reduce system and create operational efficiencies for or burdens. errors and related casework, as well as Exchanges by streamlining effective date Finally, because simplified special confusion for consumers, issuers, and options across similar special enrollment period eligibility policy caseworker and call center staff based enrollment periods with qualifying provides improved pathways to on contradictory rules for different events related to gaining or becoming a continuous coverage for special scenarios. dependent. For example, this revision to enrollment period-eligible consumers, the regulation will enable the FFE to use we anticipate that the provisions in this 11. Eligibility Standards for Exemptions a simpler online, automated application rule may result in less burden on call (§ 155.605) pathway for more special enrollment center representatives and caseworkers We do not anticipate that the period-eligible consumers, meaning that related to fewer questions about special amendment to § 155.605(d) will create fewer consumers will need to use a enrollment periods due to gaining or additional costs or burdens. The manual and costly casework process to becoming a dependent and loss of amendment to § 155.605(d)(2)(iv) will use their special enrollment period. For certain types of pregnancy-related enable the Exchanges to process the limited cases when casework support is coverage. We also anticipate that the consumer’s exemption from the required, operations would also be revisions will reduce burden on individual shared responsibility simplified. consumers, have a positive effect on the provision due to lack of affordable We acknowledge that this may not be risk pool, and not result in additional coverage based on projected income, for the case for all Exchanges, and that an costs or burdens for issuers. those not eligible for employer- Exchange that has automated the option In addition, some States that operate sponsored coverage, when there is no for consumers to elect that their Exchanges expressed concern that bronze plan available by allowing the coverage take effect on the first of the amending the plan option restrictions Exchanges to process the consumer’s

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exemption based on the lowest cost groups enrolled in SHOP QHPs for plan their employees a choice of plans. HHS Exchange metal level plan, excluding years before January 1, 2018 will not be can foresee a circumstance where an catastrophic coverage, available in the affected by the proposed changes to employer offers its employees a choice individual market through the Exchange enrollment through a SHOP until they of plans, across plan categories, and in the State in the county in which the are due to renew in a SHOP QHP for the where the employees choose to enroll in individual resides. This policy will not 2018 plan year. While some additional plans offered by multiple issuers. In this increase the burden on consumers or requirements will be imposed onto circumstance, it will also be possible Exchanges. Without these revisions, issuers, HHS anticipates that any that an issuer will receive one individuals may lack access to additional burden on issuers as a result application for enrollment from a group. qualifying or affordable health coverage, of the changes in this rule will be Under the approach to SHOP but be unable to qualify for an negated in an ultimate net reduction in enrollment being finalized, the issuer exemption from the individual shared burden as many Federal regulations are will be required to accept that single responsibility provision to purchase being removed and any additional enrollment so long as the employer’s qualifying health coverage and the requirements onto issuers mainly group has met the minimum associated financial penalty due to the consist of practices they currently participation rate for their State, or is lack of coverage in their area or the perform in the private market. enrolling between November 15 and inability to calculate whether coverage In the 2018 Payment Notice, HHS December 15, when the minimum is unaffordable. This policy will also not finalized the removal of a participation participation rate rules do not apply. result in additional costs or burdens for provision that had required certain QHP With the decrease in issuer participation issuers. issuers to participate in an FF–SHOP in in the SHOPs beginning in plan year order to participate in an FFE. As a 2018, HHS believes that a circumstance, 12. Small Business Health Options result, there has been a significant Program (Part 155, Subpart H, § 155.200, similar to the one discussed above may decrease in the number of issuers in the occur. In the absence of premium §§ 156.285 and 156.286, § 156.350, FF–SHOPs in the 2018 plan year and §§ 157.205 and 157.206) aggregation functions, issuers, under the therefore, HHS also expects fewer approach being finalized will be HHS is finalizing the proposal to grant enrollments in the FF–SHOPs for plan working directly with an employer, or additional flexibilities, for plan years year 2018. As of January 1, 2017, their appointed SHOP-registered agent beginning on or after January 1, 2018, to approximately 7,554 employer groups or broker for matters of enrollment and small employers enrolling in SHOP were enrolled in the FF–SHOPs, premium billing and payment. Under QHPs and to participating QHP issuers covering 38,749 lives. With the the new regulations, effective as of the in how they interact with a SHOP. anticipated significant decreases in QHP effective date of this rule, issuers will be These changes will be effective as of the issuer participation for enrollment required to enroll consumers into plans, effective date of the final rule and the beginning in 2018, it is not cost effective even if only one employee of a group FF–SHOPs and SBE–FPs for SHOP will for the Federal government to continue wants to enroll. Further, issuers will operate under the new enrollment to maintain certain FF–SHOP also be required to process enrollments approach. Under this final rule, several functionalities, collect significantly into SHOP QHPs, and, handle appeals existing requirements on SHOPs will reduced user fees on a monthly basis, (other than appeals related to employer not apply for plan years beginning on or maintain the technologies required to eligibility), administer special after January 1, 2018, allowing State maintain an FF–SHOP website and enrollment periods and terminations. Exchanges the flexibility to operate their payment platform, generate enrollment Issuers will still be subject to the market SHOP in a way that makes sense for the and payment transaction files, and wide effective dates outlined in small businesses in their State, with perform enrollment reconciliation. reduced limitations imposed by Federal Under the approach being finalized in § 147.104(b)(1)(i)(C). While HHS regulation. The FF–SHOPs and SBE–FPs this rule, issuers will still be subject to believes that issuers currently perform for SHOP will take advantage of the their State requirements, and HHS will the majority of these tasks, issuers may flexibility of the enrollment approach minimize Federal requirements related experience an increase in burden as it described through this final rule and to SHOP plans (that is, notice relates to the volume of consumers operate in a leaner fashion. Under the requirements, etc.) for plan years enrolling in their SHOP QHPs. Overall, approach being finalized, SHOPs are no beginning on or after January 1, 2018. HHS believes that under this approach, longer required to enroll small groups in For example, issuers are often required issuers will see a net cost savings, as SHOP QHPs through a SHOP website. by State law to generate enrollment and their business processes for SHOP Instead, small employers will, in SHOPs payment notices, and will continue to enrollments may be more closely that operate under this approach, enroll generate any State-required notices aligned with their current business through a participating QHP issuer, or a under the new SHOP enrollment practices for enrollments outside the SHOP-registered agent or broker. approach. Under the proposed SHOP, and they will no longer be HHS believes that the changes will approach, the FF–SHOPs and SBE–FPs remitting user fees for FF–SHOP and reduce burden on participating QHP for SHOP will no longer generate SBE–FP SHOP enrollments. issuers, small employers, and agents enrollment notices, but the notice As noted, SHOPs will be given the and brokers for several reasons. Under requirements for the FF–SHOPs and flexibility to adopt an enrollment the approach being finalized, for plan SBE–FPs for SHOP will not necessarily approach through which enrollments years beginning on or after January 1, be transferred directly to participating occur directly with issuers or SHOP- 2018, effective on the effective date of QHP issuers. HHS can imagine a registered agents or brokers, to continue this rule, participating QHP issuers will, scenario where an issuer might generate to operate with the same functionalities in SHOPs that operate under the new an additional notice to a SHOP as they currently do or to develop new flexibilities like the FF–SHOPs and consumer that they are not required by practices as permitted by the proposals SBE–FPs for SHOP, enroll small groups Federal law to send, but may be in this rule. In any case, SHOPs will through their existing enrollment required by State law, to send. need to meet only the regulatory channels—utilizing their existing Issuers will still be required to accept minimums outlined in this final rule, technologies and processes. Small enrollment from employers that offer therefore minimizing the overall amount

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of regulatory requirements that SHOPs issuer offering FF–SHOP plans in their charging monthly user fees to SHOP will otherwise need to meet. HHS area and will not be able to offer their issuers offering plans through an FF– believes that the new flexibility for employees a choice of plans across SHOP or SBE–FP SHOP for plan years SHOPs will result in an overall issuers. In addition, historically, a beginning on and after January 1, 2018, reduction in burden and cost for States majority of employers have not offered effective on the effective date of the operating their own SHOPs because we employee choice across different final rule. This will decrease user fee are providing States with the flexibility issuers. Therefore HHS does not believe transfers from SHOP issuers offering to pursue the enrollment approach that the potential increased burden in this plans through an FFE or SBE–FP by best meets their needs, because we are area due the removal of premium approximately $6 million. reducing the overall regulatory aggregation functions to be significant. 14. Provision of EHB requirements for the SHOP Exchanges, Employers will still be able to view a and for the same reasons described listing of all of the SHOP QHPs Under § 156.111, we provide States above regarding why the enrollment available, by plan category and issuer on with more flexibility by offering States approach being finalized will reduce a SHOP website. HHS expects that the three new methods for selecting their burdens on the FF–SHOP and its actual process of enrolling in SHOP State EHB-benchmark plans. Under this stakeholders. QHPs under this approach will be less policy, if the State does not select one Under the new enrollment approach burdensome than the existing of the three methods for changing its for SHOP plan years beginning on or enrollment approach through a SHOP EHB-benchmark plan, the State will after January 1, 2018, HHS believes that website. As previously mentioned, HHS default to its current EHB-benchmark employers seeking to purchase coverage anticipated significantly lower issuer plan. We recognize that, to the extent through an FF–SHOP or SBE–FP for participation for the SHOP in the 2018 that States take advantage of the EHB- SHOP will experience a reduction in plan year. A decrease in issuer benchmark plan selection options at regulatory burden related to enrollment, participation unfortunately also results § 156.111, States and issuers will despite the fact that they may be in less choice for consumers. While experience an increase in burden to required to visit at least two websites employers may experience an increase develop new policies and implement (the SHOP website and the issuer’s in burden, especially if offering new plan designs. We anticipate that website) prior to completing an employees a choice of plans, under the most States will need to invest resources enrollment in SHOP coverage as they new flexibilities for SHOPs, HHS to analyze the three new EHB- will be able to enroll in coverage anticipates the benefits of the finalized benchmark selection options to make an through a SHOP-registered agent or approach will ultimately outweigh the informed selection, even if the State broker or through a participating QHP minimal additional costs employers ultimately defaults. Several States may issuer—using issuers’ streamlined could face. select one of the new options, and will enrollment technologies. Employers will Further, the Federal government will need additional resources to facilitate a also be required, as described experience a dramatic reduction in the public notice and comment period and throughout this document to notify their role it plays in operating an FF–SHOP develop and submit the necessary QHP issuer of their eligibility to and the contract support that it requires documents specified by HHS (including purchase a SHOP QHP and of their in order to support it. In 2016, the cost the requisite actuarial certification) to ineligibility, if their eligibility were to of running the FF–SHOP website effectuate the State’s selection. be revoked. Employers will also be (utilized by both FF–SHOPs and SBE– Additionally, in States that choose to required to inform the SHOP if they FPs for SHOP) was approximately $30 select their EHB-benchmark plan under become ineligible to participate in a million, and HHS expects annual any of the three available options, SHOP, or choose to withdraw their expenditures to drop significantly—by issuers offering plans that provide EHB eligibility, unless the issuer is notified at least 90 percent—within a few years, will incur additional administrative by the SHOP. We believe this is still less as it responsibly wind-downs the costs associated with designing plans cumbersome than the existing eligibility integration of the FF–SHOPs. compliant with the State’s newly and enrollment process. selected EHB-benchmark plan. Under the flexibilities being finalized 13. User Fees (§ 156.50) Due to the many PPACA policies with this rule, some employers, To support the operation of FFEs, we directly or indirectly tied to EHB, HHS specifically those who offer their require in § 156.50(c) that a recognizes the impact this policy will employees a choice of plans, will participating issuer offering a plan have on parties beyond issuers required experience an increase in administrative through an FFE or SBE–FP must remit to provide EHB-compliant plans. For burden with the removal of a SHOP’s a user fee to HHS each month equal to example, the State’s new EHB- premium aggregation functions. Without the product of the monthly user fee rate benchmark selection can impact how a SHOP’s premium aggregation specified in the annual HHS notice of issuers set their annual limitation on functions, employers will have to benefit and payment parameters for the cost sharing and how issuers determine collect the enrollment and payment applicable benefit year and the monthly which benefits may not be subject to information needed from each of the premium charged by the issuer for each annual and lifetime dollar limits.104 issuers whose plans the employer policy under the plan where enrollment It is our aim that the flexibility under intends to offer to its employees. In the is through an FFE. In this final rule, for the policy will allow for States and event employees select plans from the 2019 benefit year, we set the issuers to be more innovative in multiple insurance companies, the monthly FFE user fee rate at 3.5 percent designing benefit structures that will employer will be responsible for of the monthly premium, and the ultimately affect affordability for distributing the applications for monthly SBE–FP user fee rate at 3.0 consumers. However, we realize that enrollment to the individual issuers, percent of the monthly premium. This collecting payments from the employees increase in SBE–FP user fee rate from 104 The definition of EHB also has an impact on and sending the individual payments to 2.0 percent in 2018 to 3.0 percent in the annual limitation on cost sharing at section 1302(c) of the PPACA (which is incorporated into each issuer. Due to the decrease in 2019 will increase transfers from SBE– section 2707(b) of the PHS Act) and the prohibition issuer participation in the FF–SHOPs, FP issuers to the Federal government by of annual and lifetime dollar limits at section 2711 some SHOP employers only have one $20 million. Additionally, we will cease of the PHS Act, as added by the PPACA.

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this policy will have varying impact on flexibility, and States are not required to continue to have the option to set consumers depending on how a State make any changes under this policy, we criteria for benefit substitution. chooses to implement the policy. also believe the additional flexibility in We solicited comments on the impact Consumers enrolled in individual and plan and benefit design may produce of the proposed EHB policy and on small group market plans will be long-term premium savings. The whether other impacts should be affected by changes to EHB in that their policies offer issuers in States that use considered. benefits may change and in some cases the flexibility to select a new EHB- Comment: Many commenters were premiums may increase or decrease benchmark plan the opportunity to concerned about the impact of the depending upon State implementation lower plan premiums, which will proposed EHB-benchmark plan policies. of the policies. Additionally, in States increase affordability of health Some commenters were concerned that that use one of the methods to select a insurance for consumers in the reduced benefits might lead to new EHB-benchmark plan, the new individual and small group markets consumers forgoing care, which could EHB-benchmark plan selection may who do not receive PTC and do not lead to a more serious condition that impact the amount of PTC and CSRs for require the benefits that are no longer would increase or shift costs. Some enrollees in the State. For these considered EHB. commenters focused on the potential consumers, subsidies will increase or When adjusting coverage of services downstream effects, with most decrease when compared to their State’s under the options, we encourage States commenters agreeing with our current EHB-benchmark plan. PTC is to consider the spillover effects in assessment that there may be potential available only for that portion of a addition to the costs and utilization of downstream effects that a State would plan’s premium attributed to EHB. To these services. Spillover effects include want to take under consideration, with the extent that a State’s EHB-benchmark increased use of other services, such as some noting that the spillover could plan, under the policy, leads to lower increased use of emergency services or also affect the productivity of the premiums for the second lowest cost increased use of public services nation, leading to even higher silver plan, PTC will be reduced, but not provided by the State or other government costs. the percent of income a consumer with government entities, when a certain Commenters on the premium impact PTC is expected to contribute to their service is no longer covered by and cost impact of the proposed policy premium. This effect will represent a insurance. Depending on the State typically were concerned that reducing transfer from consumers who receive population’s use of services and health benefits would only have a minor or no PTC to the Federal government. care needs, States may arrive at different premium impact and would result in Individual and small group market conclusions about the effects of consumers having to pay more for enrollees who do not receive PTC will adjusting a particular benefit. Because services that are not covered, which experience lower premiums for less we do not know how States will choose some noted is not what consumers comprehensive coverage that can result to adjust their benchmark plans, we are want. Some of these commenters noted in more affordable coverage options but not able to predict the effects these that premiums are affected by other possibly higher out-of-pocket costs for modifications may have on costs. factors than benefits while some the consumer. We anticipate that States are more Additionally, we also proposed at commenters were concerned about the likely to select EHB-benchmark plans § 156.115 to allow for benefit risk pool impact and risk adjustment under this policy such that premiums substitution to occur within the same since enrollment could be affected by have the potential to be reduced in the EHB category or between EHB categories the scope of benefits being offered. long-term to achieve affordability in to offer additional issuer flexibility. Other commenters noted that Medicaid, benefit design. However, even with the Because issuers are already familiar the large group and self-insured plans, generosity standard now being applied with substituting benefits within benefit and PTC are also affected by the to all of the EHB-benchmark selection categories, we did not believe that definition of EHB. options, the policy may provide some broadening the policy to allow benefit Commenters also opposed allowing ability for States, depending on the substitution between benefit categories issuers to substitute benefits between State, to select EHB-benchmark plans in would create additional burden for EHB categories. Commenters cited a a manner that will increase premiums. issuers. We are finalizing § 156.115 to wide range of concerns, including those To the extent that a State’s EHB- allow issuers to substitute benefits we acknowledged in the proposed rule, benchmark plan leads to higher between EHB categories to the extent as well as several that we did not, and premiums for the second lowest cost allowed by the State, beginning in plan suggested that the proposal’s negative silver plan, PTC will be increased. year 2020. As finalized, this rule will impact would be significant. For Consumers who have specific health increase burden on consumers, when example, commenters noted that this needs may also be affected by the their State allows between-category type of substitution would permit policy. In the individual and small substitution and issuers in their State issuers to design plans so that they were group markets, depending on the utilize such substitution. Under such unattractive to people with certain high- selection made by the State in which the circumstances, consumers who choose cost health conditions, or people with consumer lives, consumers with less between plans offered in the individual conditions not adequately reimbursed comprehensive plans may no longer and small group markets may need to by risk adjustment. They voiced have coverage for certain services. In spend more time and effort comparing concerns that this new market dynamic other States, again depending on State benefits offered by different plans in could harm the individual market risk choices, consumers may gain coverage order to determine what, if any, benefits pool and State risk adjustment for some services. are substituted, and what plan would programs, as well as imposing burden As explained above, HHS anticipates best suit their health care and financial on certain individuals with chronic or that § 156.111 will generate additional needs. However, some consumers may high cost conditions affected by the lack costs for States, issuers, and certain benefit from expanded access to plans of coverage options that met their needs consumers in the short run. However, that better suit their needs. We also note and the difficulty of comparing plans although we are uncertain as to how that States are generally primarily due to the increased complexity of plan States will take advantage of this responsible for enforcement of EHB and design.

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Commenters also stated that for substitution between categories. We report a SADP’s AV is newly codified in substitution between EHB benefit also expect minimal impact on issuers, regulation, issuers of SADPs previously categories is significantly different than since they have experience in reported level of coverage as part of the substitution within categories and, substituting benefits within EHB QHP certification process, so this therefore that current substitution categories and may decline to substitute change is not expected to have an practices do not provide helpful between categories even when their impact on issuers’ reporting burden. precedent for plan design, or for States’ State allows it. 16. Qualified Health Plan Certification review of plans that include substitution We anticipate both additional burden within categories. One commenter and benefit for consumers, to the extent For plan years 2019 and later, we stated that it would be particularly that their States permit and issuers proposed to further expand the role of difficult to establish actuarial utilize substitution between EHB States in the QHP certification process equivalence between benefits from categories. It may require greater time for FFEs, including FFEs where the different EHB-benefit categories, which and effort for consumers to choose State performs plan management could result in added burden for State among plans in the individual and small functions. Specifically, we proposed to regulators and for issuers required to group market if some of those plans defer to States for additional review comply with varying standards in substitute some benefits for those in areas, including accreditation different States. One commenter added separate EHB categories. However, we requirements at § 156.275, compliance that while this proposal would allow anticipate that this additional time and reviews at § 156.715, minimum States to bar issuers from using benefit effort will be limited because issuers geographic area of the plan’s service substitution between EHB categories, must meet the requirement at area at § 155.1055, and quality some States would need to take this step § 156.115(b)(3)(i) to provide benefits improvement strategy reporting at through legislative action, which would that are substantially equal to their § 156.1130, if feasible and appropriate. require time and resources simply to State’s EHB-benchmark plan. The We received comments that this policy maintain their current policy. Finally, impact on consumers of the substituted would impose burdens on States, we did not receive any examples of how benefits themselves will be mixed— particularly those States that are not issuers could use substitution between some consumers stand to benefit by performing these reviews, and we are EHB benefit categories to improve gaining access to benefits they desire not finalizing this proposal for these coverage options. that would not have been provided four review areas. Some States Response: In response to commenters, without this policy, while other commented that they presently lack we are finalizing the new EHB- consumers may find that a particular resources, including staffing resources, benchmark plan options at § 156.111 issuer no longer offers benefits they to conduct these reviews. We are with certain modifications. Because we desire. Benefits no longer offered by one finalizing a policy to extend for the 2019 do not know how States will choose to issuer, however, may be offered by benefit year and beyond the QHP adjust their benchmark plans, we are another issuer. The net effect is certification review standards related to not able to predict the effects these uncertain. network adequacy and ECPs that we modifications may have on costs. finalized in the Market Stabilization 15. Application to Stand-Alone Dental Furthermore, we also recognize that the rule. We do not anticipate this policy Plans Inside the Exchange (§ 156.150) effects of a specific change will likely will increase burden on States because vary from State to State given market We are removing AV level of coverage we believe these reviews are already and demographic differences. Therefore, requirements for SADP issuers for being performed by States. We we emphasize that States may also wish coverage of pediatric dental EHB, anticipated slight reduction in burden to consider a variety of different factors however we are maintaining the AV for issuers due to not needing to when selecting an EHB-benchmark plan. certification requirement at revised undergo duplicative reviews and a We encourage States to consider the § 156.150(b)(2) and codifying an reduction in costs to the Federal impact of the EHB-benchmark plan’s operational requirement that such government. We sought comment on scope of benefits on the availability of certification be reported to the whether there are burdens we are not PTC and CSRs for enrollees in the State, Exchange, which issuers of SADPs have considering. While commenters as the PTC is based on the amount of already been fulfilling, as part of the expressed concern that these policies premiums allocable to EHB, and CSRs QHP certification process. We estimate could increase burden for consumers to provide reduced cost sharing for EHB that the change in AV could lead to a obtain care from needed providers, we only. Additionally, we encourage States reduction in premiums for certain believe that State reviews related to to consider the impact on Medicaid, and SADPs. Issuers may choose to offer network adequacy are capable of on large group and self-insured group more SADPs at varying premiums and adequately preserving consumer access health plans. While we cannot predict levels of coverage. The offering of more to care from such providers. the effects of the policy, we hope that SADPs and SADPs with lower We are removing the meaningful this policy, as finalized, allows States premiums may lead to increased difference standard at § 156.298. Issuers the flexibility to innovate their EHB- enrollment in SADPs. Because certain will have a potential reduction in benchmark plans that balances access eligible taxpayers can use PTC to pay for administrative costs since they will no and costs. We hope to learn from those the portion of SADP premiums longer have to implement their internal States that choose a new EHB- attributable to EHB, a reduction in assessments as to whether their plan benchmark plan under this policy, as premiums will likely reduce the offerings meet this standard. We we consider creating a Federal default premium for purposes of the PTC, acknowledged and commenters noted benchmark plan in the future. leading to a small transfer from credit that consumers may have more QHPs to We appreciate commenters’ concerns recipients to the government. If select from which may increase the about the impact of allowing enrollment increases due to potentially burden in selecting a QHP. However, we substitution between EHB categories. lower premiums there may be an overall do not have evidence from any We assess the impact on States to be increase in the total PTC payments by Exchange that removing the meaningful minimal, as under the final rule they the government. The net effect is difference standard creates any new have authority to withhold permission uncertain. While the requirement to burden on consumers.

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We also anticipate that the removal of economic impact. Therefore, we do not 19. Medical Loss Ratio (Part 158) the meaningful difference standard will believe the provisions related to cost- We are amending § 158.221(b) to reduce the regulatory burden on SBE– sharing reductions in this final rule will allow issuers the option to report a FPs. Under § 155.200(f)(2)(iv), SBE–FPs have an impact on the program single quality improvement activity are required to establish and oversee established by and described in past expense amount equal to 0.8 percent of requirements for their issuers that are no Payment Notices. earned premium, in lieu of reporting the We also finalized the premium less stringent than the meaningful actual QIA amounts in five separate adjustment percentage for the 2019 difference standard as it applies to categories described in benefit year. Under § 156.130(e), and issuers participating in the FFEs. SBE– § 158.150(b)(2)(i)–(v). Based on MLR under the methodology established in FPs will no longer need to establish data for the 2015 MLR reporting year, the 2015 Payment Notice and amended such a standard or oversee it. HHS estimates that the amendment will in the 2015 Market Standards Rule for We are removing the requirements for decrease rebate payments from issuers estimating average per capita premium SBE–FPs to enforce FFE standards for to consumers by approximately $23 network adequacy at § 155.200(f)(2)(ii) for purposes of calculating the premium adjustment percentage, the premium million. and essential community providers at We are also amending several sections § 155.200(f)(2)(iii). We anticipate that adjustment percentage is the percentage (if any) by which the average per of 45 CFR part 158, subpart C SBE–FPs will have a potential reduction (§§ 158.301, 158.321–158.322, 158.330, in administrative costs since they will enrollee premium for employer- sponsored health insurance coverage for 158.341, 158.350) to modify the process have the flexibility to determine how to and criteria for the Secretary to implement the network adequacy and the preceding calendar year exceeds such average per enrollee premium for determine whether to adjust the 80 essential community provider standards percent MLR standard in the individual with which issuers offering QHPs employer-sponsored health insurance for 2013. The annual premium market in a State. While it is uncertain through the SBE–FP must comply. We what specific adjustments States may believe SBE–FPs are best positioned to adjustment percentage sets the rate of increase for three parameters detailed in request, most adjustments previously determine these standards for the QHP granted by the Secretary have ranged certification process in their States, and the PPACA: The annual limitation on cost sharing (defined at § 156.130(a)), from 70 to 75 percent. Based on MLR that the removal of the requirement that data for the 2015 MLR reporting year, SBE–FPs establish and oversee the required contribution percentage used to determine eligibility for certain and assuming that 22 States will request requirements for their issuers that are no an adjustment (including 17 States that less strict that the manner in which exemptions under section 5000A of the Code, and the assessable payments previously requested adjustments prior these regulatory requirements are to 2014), HHS estimates that the applied to FFE issuers will streamline under sections 4980H(a) and 4980H(b) of the Code. We believe that the 2019 amendments will decrease rebate certain aspects of the QHP certification payments from issuers to consumers or process, reduce issuer burden, and premium adjustment percentage is well within the parameters used in the increase premiums paid by consumers return traditional insurance market to issuers by approximately $52 million regulatory authority to the States. modeling of the PPACA, and we do not expect that these provisions will alter (assuming a reduction of the 80 percent 17. Provisions Related to Cost Sharing CBO’s March 2016 baseline estimates of MLR standard to 75 percent for all 22 (§ 156.130) the budget impact. States) to $64 million (assuming a reduction of the MLR standard to 70 The PPACA provides for the 18. Minimum Essential Coverage percent for all 22 States) annually, for reduction or elimination of cost sharing (§ 156.602, § 156.604) up to 3 years at a time. This represents for certain eligible individuals enrolled We proposed to designate CHIP buy- an estimated 74 percent to 91 percent in QHPs offered through the Exchanges. in programs that provide identical reduction, respectively, in rebates This assistance helps many low- and coverage to the CHIP program under payable in those 22 States, which moderate-income individuals and title XXI of the Act in the applicable together accounted for $70 million out families obtain health insurance—for State as minimum essential coverage. of the nationwide total $107 million in many people, cost sharing is a barrier to This final rule does not provide 105 rebates that issuers owed to individual obtaining needed health care. categorical designation of CHIP buy-in market consumers for 2015. The actual We set forth in this final rule the programs as minimum essential reduction in rebates may be lower or reductions in the maximum annual coverage. States will have the option of higher depending on which States apply limitation on cost sharing for silver plan electronically submitting to HHS for an adjustment, and whether and how variations. Consistent with our analysis information regarding their plans and, much the Secretary may adjust the in previous Payment Notices, we after review and comparison of the individual market MLR standard in each developed three model silver level coverage, HHS will verify whether or State. QHPs and analyzed the impact on their not the CHIP buy-in programs provide at AVs of the reductions described in the least the same coverage as the title XXI 20. Regulatory Review Costs PPACA to the estimated 2019 maximum CHIP programs, such that they If regulations impose administrative annual limitation on cost sharing for statutorily qualify as minimum essential costs on private entities, such as the self-only coverage. We do not believe coverage. Currently, very few States time needed to read and interpret this these changes will result in a significant offer CHIP buy-in programs, and such final rule, we should estimate the cost plans in two States have applied for and associated with regulatory review. Due 105 Brook, Robert H., John E. Ware, William H. Rogers, Emmett B. Keeler, Allyson Ross Davies, been recognized as minimum essential to the uncertainty involved with Cathy D. Sherbourne, George A. Goldberg, Kathleen coverage. Of the States that opt into the accurately quantifying the number of N. Lohr, Patricia Camp and Joseph P. Newhouse. verification process, there will be a entities that will review the rule, we The Effect of Coinsurance on the Health of Adults: reduction in burden related to making assume that the total number of unique Results from the RAND Health Insurance Experiment. Santa Monica, CA: RAND Corporation, changes to their plans to provide at least commenters on the proposed rule will 1984. Available at http://www.rand.org/pubs/ the same coverage as the title XXI CHIP be the number of reviewers of this final reports/R3055. program. rule. We acknowledge that this

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assumption may understate or overstate estimated cost of approximately effect of the reduction on State’s market the costs of reviewing this rule. It is $673,024. risk pool. We determined that to ensure possible that not all commenters issuers are adequately compensated for D. Regulatory Alternatives Considered reviewed the proposed rule in detail, the actuarial risk of their enrollees and and it is also possible that some In developing the policies contained do not have incentives to avoid higher reviewers chose not to comment on the in the final rule, we considered risk enrollees, the State regulators need proposed rule. For these reasons we numerous alternatives to the policies to submit evidence and analysis thought that the number of past being finalized. Below, we discuss the demonstrating the State-specific factors commenters would be a fair estimate of key regulatory alternatives that we that warrant an adjustment to more the number of reviewers of this rule. considered. precisely account for the differences in We are required to promulgate a For the 2019 benefit year, we actuarial risk in the State’s market. substantial portion of this rule each year considered using only the 2016 benefit States must also justify the percentage under our regulations and we estimate year enrollee-level EDGE data to reduction by providing evidence and that approximately half of the remaining recalibrate the risk adjustment model analysis demonstrating the State- provisions will cause additional coefficients. However, this could lead to specific factors and the percentage by regulatory review burden that uncertainty in issuers’ expectation of which those factors warrant an risk adjustment transfers due to the sole stakeholders do not already anticipate. adjustment to more precisely account use of a new dataset for recalibrating the We also recognize that different types of for the differences in actuarial risk in model coefficients. We believe that entities are in many cases affected by the State’s market as compared to the blending multiple years of data will mutually exclusive sections of this national norm, or demonstrating the promote stability for the risk adjustment proposed rule, and therefore for the requested reduction in risk adjustment coefficients year-to-year, particularly for purposes of our estimate we assume that payments would be so small for issuers rare conditions with small sample sizes. each reviewer reads approximately 50 who would receive risk adjustment Therefore, we proposed to blend percent of the rule, excluding the payments, that the reduction would coefficients calculated from the 2016 portion of the rule that we are required have a de minimis effect on the benefit year enrollee-level EDGE data necessary premium increase to cover the to promulgate each year. ® with 2014 and 2015 MarketScan data. affected issuer’s or issuers’ reduced Using the wage information from the Additionally, given the timing of the BLS for medical and health service payments. We also considered only proposed rule, we were unable to making the flexibility available to States managers (Code 11–9111), we estimate analyze the 2016 enrollee-level EDGE that the cost of reviewing this rule is in the small group market, but data in time to publish the coefficients determined that just as with the States’ $105.16 per hour, including overhead calibrated using the EDGE data in the 106 small group markets, it is possible that and fringe benefits. Assuming an proposed rule. Similar to the 2018 average reading speed, we estimate that the national methodology may not benefit year final risk adjustment precisely account for unique State it will take approximately 1 hour for the coefficients, we considered publishing staff to review the relevant portions of market dynamics in the individual or the 2019 benefit year final risk merged markets. this proposed rule that causes adjustment coefficients in guidance after For the risk adjustment data unanticipated burden. We received 416 the publication of the final rule with validation program, HHS considered ® comments, including 99 comments that more recent MarketScan data that will alternate approaches for evaluating error were substantially similar to one of four become available at the end of this year. rates and adjusting risk scores when an different letters, resulting in 322 unique However, the 2016 benefit year enrollee- error rate deviates from a statistically comments on the proposed rule. We level risk adjustment data was available significant value. We considered assume that for form letters, only the in time to complete our analysis and calculating a national central tendency staff at the organization that arranged for publish the final coefficients in this of errors and then adjusting risk scores those letters will review the final rule. rule. Additionally, we considered but only when an error rate that falls For each entity that reviews the rule, the did not propose to use the 2016 outside of the confidence interval ® estimated cost is $105.16. Therefore, we MarketScan data that will become around the national central tendency; estimate that the total cost of reviewing available at the end of this year for the however, we determined that the this regulation is approximately $33,862 2019 benefit year risk adjustment model × evaluation of error rates relative to a ($105.16 322 reviewers). This may recalibration. We also considered national average would likely result in underestimate the review costs, since assigning higher weights to the significantly less accurate risk score not all reviewers may have submitted coefficients solved from more recent adjustments, primarily because it would comments. In addition, stakeholders data, however, to allow stability in the not account for differences in error rates that will need to do a detailed analysis market have equally blended the 3 years due to issuer size or the distribution of in order to implement the unanticipated of data. We are finalizing the 2019 HCCs in the enrollee population. provisions of this rule will need benefit year model coefficients blended We considered maintaining the additional time and personnel, which with 2016 EDGE data, and 2014 and current applicability of the Federal rate will vary depending on the extent to 2015 MarketScan® data published in review requirements, and continuing to which they are affected. To estimate an this rule. review the reasonableness of student upper bound, we assumed that on For the State flexibility to request health insurance coverage rate increases average 530 issuers and 50 States will reductions of other applicable risk subject to review. However, this rule spend 10 hours each, 100 other adjustment transfers, we considered will provide States with greater organizations will spend 5 hours each alternate requirements for States flexibility to meet the needs of their and 100 individuals will spend 1 hour requesting a reduction. We considered markets and reduce the burden each to review the rule. Under these requiring actuarially certified standards, associated with review of plans that are assumptions, total time spent reviewing State’s attestation noting consensus not part of the single risk pool. As a the rule would be 6,400 hours with an from all issuers of risk adjustment practical matter, student health covered plans in the State’s market, or insurance coverage has generally been 106 https://www.bls.gov/oes/current/oes_nat.htm. simulation studies demonstrating the given the same plan design flexibility as

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plans in the large group market. Just like not require employers to provide to the expanded de minimis range for QHPs purchasers of large group plans, Exchange the relevant information on (¥4/+2 percentage points) or of +/¥3 purchasers in the student market are what coverage they offer, Exchanges and percentage points. We determined that viewed as more sophisticated, with HHS would not receive data from all these alternatives were less desirable greater leverage and ability to avoid the employers. After weighing our options, because they do not provide issuers imposition of unreasonable rate we decided that this approach would be with as much flexibility to offer a range increases. Single risk pool pricing, the overly costly and burdensome, and of of SADPs as the proposed removal of primary focus of the rate review limited value due to gaps in the data the AV standards for SADPs. We program, does not apply to student Exchanges and HHS would be able to finalized the policy to remove the level health insurance coverage. collect. We also considered removing of coverage AV requirement for SADPs We considered maintaining the the requirement to connect to an HHS- as proposed, but retained a requirement current 30-day notice requirement for approved data source, and the to certify AV and codified an States to notify HHS prior to posting the requirement to use an alternative operational requirement that such required information on proposed and method if the Exchange does not certification be reported to the final rate increases. However, such connect to the required data sources, but Exchange, which SADP issuers already advanced notice may be impractical in were concerned about the potential have been doing, as part of the QHP some States so we have decreased the impact on program integrity. certification process. For the QHP notice requirement to 5 business days. In finalizing the policy related to the certification standard regarding We considered permitting States to post SHOP enrollment process, we meaningful difference, we considered the required information on rate considered maintaining the status quo, maintaining the requirement on issuers, increases on a rolling basis. However, but believe that the increase in but we believe that removing this we agree with the concerns shared by flexibility, cost savings and reduction in provision will promote the offering of a the majority of public comments burden resulting from the new variety of affordable QHPs that will opposing that proposal, so we are enrollment approach, will have a meet consumers’ needs, will provide maintaining the uniform posting positive impact on small businesses issuers with more flexibility, and will requirement. across the country and provide States remove an unnecessary regulatory In adding standards for § 155.221, with needed flexibility. requirement. HHS considered making no changes to In finalizing the policy for the new For the amendments to § 158.221(b), the existing rule and retaining the EHB-benchmark plan selection options we considered retaining the current existing standard for agents and brokers described at § 156.111, we considered a quality improvement activity reporting to contract with a third-party entity variety of alternatives, including requirements, since giving issuers the approved by HHS for conducting audits maintaining the current EHB-benchmark option to report a standardized rate for under the section. In finalizing the policy without modification. Although QIA expenditures may inhibit HHS from proposal, we continue to believe that it maintaining the current policy would being able to analyze trends in issuers’ is necessary to include issuers and to have promoted stability by preserving investment in improving the quality of provide the necessary flexibility in the current EHB-benchmarks across all health care in the future, and may also oversight that both protects consumers States, we do not believe it would have reduce rebates to consumers by allowing and encourages enrollment pathway offered the additional flexibility that issuers to effectively increase their innovation for agents, brokers, and States have requested in selecting an MLRs by 0.8 percent even if those issuers using direct enrollment. EHB-benchmark plan to best meet the issuers engaged in and spent only trivial For the amendments to § 155.320, we needs of their consumer population. We amounts on QIA. However, this change considered developing a comprehensive also considered whether it was feasible will also potentially level the playing database using information from to offer States increased flexibility by field among issuers to a certain extent employers on the plans they offer to allowing them to set a range of and lead to more accurate rebate their employees and their family acceptable EHB within their State, such payments, since many issuers likely do members that could satisfy verification that issuers could offer plans within that engage in QIA but forego reporting that requirements under paragraph (d)(2) for range with more limited EHB coverage spending because the burden of all Exchanges. This approach would be or more robust EHB coverage. However, analyzing, documenting, tracking, resource-intensive for Exchanges, and we determined that this option did not allocating, and reporting QIA expenses would produce a database with limited meet statutory requirements. To balance exceeds the benefits for MLR purposes. utility due to data limitations. stability, flexibility, and statutory Because the finalized approach of giving Developing a database; recruiting and requirements, we instead finalized the issuers the option to report a minimal, educating employers to participate in proposal to offer States the expanded standardized rate will reduce voluntarily submitting the data; and EHB-benchmark plan selection options unwarranted regulatory and economic providing technical assistance to at § 156.111, as well as the option to burdens for issuers that do not want to employers for the first year of default to the State’s current EHB- track and report the exact QIA amounts implementation on how to input the benchmark plan. We believe this for their MLR calculation, we believe data is estimated to cost at least $38 approach will provide States with the that the finalized approach will be more million. Building such a database would opportunity to take advantage of greater effective and represents a better balance also rely on the voluntary participation flexibility in selecting an EHB- than the current requirements. of substantially all employers. This benchmark plan while also providing For the amendments to part 158, participation would be onerous for those States that value stability with the subpart C, we considered retaining the employers. Employers would need to option to retain their current benchmark current requirements for States to provide individual employee level data plan. request an adjustment to the 80 percent regarding plans the employer will offer, With respect to the provision MLR standard in the individual market information that may not be available in regarding removing the AV requirement in a State. However, HHS recognizes time to populate a comprehensive for SADPs, we considered making no that many of the current State database prior to the Exchange’s plan change or proposing an expansion to the application requirements are year. In addition, since the PPACA does de minimis range to mirror the burdensome and less relevant in the

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post-2014 reformed environment, and million or less.107 We believe that few, MLR will not affect a substantial may preclude or discourage States from if any, insurance companies selling number of small entities, and further, proposing innovative solutions to help comprehensive health insurance the impact of the proposed QIA stabilize their individual markets. policies (in contrast, for example, to provisions on small entities will be Therefore, we believe the finalized travel insurance policies or dental positive. discount policies) fall below these size amendments will reduce regulatory F. Unfunded Mandates burdens on States, and provide States thresholds. with an additional tool to promote This final rule will allow enrollment Section 202 of the Unfunded stability in their individual markets. in a SHOP QHP through a SHOP- Mandates Reform Act of 1995 (UMRA) registered agent or broker, or through a requires that agencies assess anticipated E. Regulatory Flexibility Act participating QHP issuer. The SHOPs costs and benefits and take certain other The Regulatory Flexibility Act, (5 are generally limited by statute to actions before issuing a final rule that U.S.C. 601, et seq.), requires agencies to employers with at least one but not includes any Federal mandate that may prepare an initial regulatory flexibility more than 50 employees, unless a State result in expenditures in any 1 year by analysis to describe the impact of the opts to provide that employers with a State, local, or Tribal governments, in proposed rule on small entities, unless from 1 to 100 employees are ‘‘small the aggregate, or by the private sector, of the head of the agency can certify that employers.’’ For this reason, we expect $100 million in 1995 dollars, updated the rule will not have a significant that many employers who will be annually for inflation. Currently, that economic impact on a substantial affected by the finalized policies will threshold is approximately $148 number of small entities. The RFA meet the SBA standard for small million. Although we have not been generally defines a ‘‘small entity’’ as (1) entities. We do not believe that the able to quantify all costs, we expect the a proprietary firm meeting the size finalized policies impose requirements combined impact on State, local, or standards of the Small Business on employers offering health insurance Tribal governments and the private Administration (SBA), (2) a not-for- through a SHOP that are more restrictive sector to be below the threshold. profit organization that is not dominant than the current requirements on small G. Federalism in its field, or (3) a small government businesses offering employer sponsored Executive Order 13132 establishes jurisdiction with a population of less insurance. We believe the processes that certain requirements that an agency than 50,000. States and individuals are we have established constitute the must meet when it promulgates a final not included in the definition of ‘‘small minimum amount of requirements rule that imposes substantial direct entity.’’ HHS uses a change in revenues necessary to implement the SHOP costs on State and local governments, of more than 3 to 5 percent as its program and accomplish our policy preempts State law, or otherwise has measure of significant economic impact goals, and that no appropriate regulatory alternatives can be developed to further Federalism implications. on a substantial number of small In compliance with the requirement entities. lessen the compliance burden. Based on data from MLR annual of Executive Order 13132 that agencies This final rule includes standards for examine closely any policies that may the risk adjustment and risk adjustment report submissions for the 2015 MLR reporting year, approximately 92 out of have Federalism implications or limit data validation programs, which are the policy making discretion of the intended to stabilize premiums as over 530 issuers of health insurance coverage nationwide had total premium States, HHS has engaged in efforts to insurance market reforms are revenue of $38.5 million or less. This consult with and work cooperatively implemented and Exchanges facilitate estimate may overstate the actual with affected States, including increased enrollment. Because we number of small health insurance participating in conference calls with believe that insurance firms offering companies that may be affected, since and attending conferences of the comprehensive health insurance almost 50 percent of these small National Association of Insurance policies generally exceed the size companies belong to larger holding Commissioners, and consulting with thresholds for ‘‘small entities’’ groups, and many if not all of these State insurance officials on an established by the SBA, we do not small companies are likely to have non- individual basis. believe that an initial regulatory health lines of business that would While developing this rule, HHS flexibility analysis is required for such result in their revenues exceeding $38.5 attempted to balance the States’ firms. million. We estimate that 57 of these 92 interests in regulating health insurance For purposes of the RFA, we expect potentially small entities may issuers with the need to ensure market the following types of entities to be experience a decrease in the rebate stability. By doing so, it is HHS’s view affected by this final rule: amount owed to consumers under the that we have complied with the • Health insurance issuers. amendments to the quality requirements of Executive Order 13132. • Group health plans. improvement activity reporting Because States have flexibility in We believe that health insurance provisions in part 158, and 27 of these designing their Exchange and Exchange- issuers and group health plans will be 57 entities are part of larger holding related programs, State decisions will classified under the North American groups. In addition, we estimate that no ultimately influence both administrative Industry Classification System code small entities will be impacted by the expenses and overall premiums. States 524114 (Direct Health and Medical amendments to 45 CFR part 158, are not required to establish an Insurance Carriers). According to SBA subpart C. Therefore, we believe that the Exchange or risk adjustment program. size standards, entities with average provisions of this final rule regarding For States that elected previously to annual receipts of $38.5 million or less operate an Exchange, or risk adjustment would be considered small entities for 107 ‘‘Table of Small Business Size Standards program, much of the initial cost of these North American Industry Matched to North American Industry Classification creating these programs was funded by Classification System codes. Issuers may System Codes’’, effective February 26, 2016, U.S. Exchange Planning and Establishment possibly be classified in 621491 (HMO Small Business Administration, available at https:// www.sba.gov/contracting/getting-started-contractor/ Grants. After establishment, Exchanges Medical Centers) and, if this is the case, make-sure-you-meet-sba-size-standards/table- must be financially self-sustaining, with the SBA size standard would be $32.5 smallbusiness-size-standards. revenue sources at the discretion of the

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State. Current State Exchanges charge furtherance of this requirement, section local governments, Sunshine Act, user fees to issuers. 2(c) of Executive Order 13771 requires Technical assistance, Women, Youth. In HHS’s view, while this final rule that the new incremental costs 45 CFR Part 157 will not impose substantial direct associated with new regulations shall, to requirement costs on State and local the extent permitted by law, be offset by Employee benefit plans, Health governments, this regulation has the elimination of existing costs insurance, Health maintenance Federalism implications due to direct associated with at least two prior organizations (HMO), Health records, effects on the distribution of power and regulations. This final rule is an E.O. Hospitals, Indians, Individuals with responsibilities among the State and 13771 deregulatory action.108 disabilities, Medicaid, Organization and Federal governments relating to functions (Government agencies), Public determining standards relating to health List of Subjects assistance programs, Reporting and insurance that is offered in the 45 CFR Part 147 recordkeeping requirements, Technical individual and small group markets. For Health care, Health insurance, assistance, Women and youth. example, we are finalizing proposals to Reporting and recordkeeping 45 CFR Part 158 provide States with substantially more requirements. flexibility in selecting an EHB- Administrative practice and benchmark plan, to explore ways to 45 CFR Part 153 procedure, Claims, Health care, Health make it easier for States to establish and Administrative practice and insurance, Penalties, Reporting and maintain a State Exchange, to provide procedure, Health care, Health recordkeeping requirements. States with substantially more flexibility insurance, Health records, For the reasons set forth in the in how they operate a SHOP, to provide Intergovernmental relations, preamble, the Department of Health and States with the option to request a Organization and functions Human Services amends 45 CFR parts reduction to risk adjustment transfers in (Government agencies), Reporting and 147, 153, 154, 155, 156, 157 and 158 as their small group market; and to make recordkeeping requirements. set forth below. it easier for States to apply for and be granted an adjustment to the MLR 45 CFR Part 154 PART 147—HEALTH INSURANCE standard in their State. We are also Administrative practice and REFORM REQUIREMENTS FOR THE returning flexibility to States in their procedure, Claims, Health care, Health GROUP AND INDIVIDUAL HEALTH review of rate increases. We are also insurance, Penalties, Reporting and INSURANCE MARKETS finalizing the proposal to give States the recordkeeping requirements. choice to review rate increases for ■ 1. The authority citation for part 147 45 CFR Part 155 student health insurance coverage. We continues to read as follows: are also reducing the advanced Administrative practice and Authority: Secs. 2701 through 2763, 2791, notification that States must give HHS procedure, Advertising, Brokers, and 2792 of the Public Health Service Act (42 about the posting of rate increases from Conflict of interests, Consumer U.S.C. 300gg through 300gg–63, 300gg–91, 30 days to 5 business days. Finally, protection, Grants administration, Grant and 300gg–92), as amended. States will no longer be required to seek programs—health, Health care, Health ■ 2. Section 147.102 is amended by approval if the State-specific threshold insurance, Health maintenance revising paragraph (c)(3)(iii)((D) to read for reasonableness review is lower than organizations (HMO), Health records, as follows: the Federal default rate review Hospitals, Indians, Individuals with threshold. disabilities, Intergovernmental relations, § 147.102 Fair health insurance premiums. Loan programs—health, Medicaid, * * * * * H. Congressional Review Act Organization and functions (c) * * * This final rule is subject to the (Government agencies), Public (3) * * * Congressional Review Act provisions of assistance programs, Reporting and (iii) * * * the Small Business Regulatory recordkeeping requirements, Technical (D) To the extent permitted by Enforcement Fairness Act of 1996 (5 assistance, Women and youth. applicable State law and, in the case of U.S.C. 801, et seq.), which specifies that coverage offered through a SHOP, as 45 CFR Part 156 before a rule can take effect, the Federal permitted by the SHOP, apply this agency promulgating the rule shall Administrative practice and paragraph (c)(3)(iii) uniformly among submit to each House of the Congress procedure, Advertising, Advisory group health plans enrolling in that and to the Comptroller General a report committees, Conflict of interests, product, giving those group health plans containing a copy of the rule along with Consumer protection, Grant programs— the option to pay premiums based on other specified information, and has health, Grants administration, Health average enrollee premium amounts. been transmitted to Congress and the care, Health insurance, Health * * * * * maintenance organization (HMO), Comptroller for review. ■ 3. Section 147.104 is amended by— Health records, Hospitals, Indians, ■ a. Revising paragraphs (b)(1)(i)(B), I. Reducing Regulation and Controlling Individuals with disabilities, Loan (b)(1)(i)(C) and (b)(1)(ii); Regulatory Costs programs—health, Medicaid, ■ b. Removing paragraph (b)(1)(iii); and Executive Order 13771, titled Organization and functions ■ c. Revising paragraphs (b)(2)(i) Reducing Regulation and Controlling (Government agencies), Public introductory text and (ii). Regulatory Costs, was issued on January assistance programs, Reporting and The revisions read as follows: 30, 2017. Section 2(a) of Executive recordkeeping requirements, State and Order 13771 requires an agency, unless § 147.104 Guaranteed availability of prohibited by law, to identify at least 108 We estimate cost savings of approximately coverage. two existing regulations to be repealed $52.74 million in 2018, $58.12 million in 2019, and * * * * * annual cost savings of $4.12 million thereafter. when the agency publicly proposes for Thus the annualized value of cost savings, as of (b) * * * notice and comment, or otherwise 2016 and calculated over a perpetual time horizon (1) * * * promulgates, a new regulation. In with a 7 percent discount rate, is $9.26 million. (i) * * *

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(B) In the case of a group health plan Authority: Secs. 1311, 1321, 1341–1343, (A) That State-specific rules or other in the small group market that cannot Pub. L. 111–148, 24 Stat. 119. relevant factors warrant an adjustment comply with employer contribution or ■ 5. Section 153.320 is amended by to more precisely account for relative group participation rules for the offering adding paragraph (d) to read as follows: risk differences in the State individual, of health insurance coverage, as allowed small group or merged market and under applicable State law, and in the § 153.320 Federally certified risk support the percentage reduction to risk case of a QHP offered in the SHOP, as adjustment methodology. adjustment transfers requested; or permitted by § 156.285(e) or § 156.286(e) * * * * * (B) That State-specific rules or other of this subchapter, a health insurance (d) State flexibility to request relevant factors warrant an adjustment issuer may restrict the availability of reductions to transfers. Beginning with to more precisely account for relative coverage to an annual enrollment period the 2020 benefit year, States can request risk differences in the State’s individual, that begins November 15 and extends to reduce risk adjustment transfers in small group or merged market and the through December 15 of each calendar the State’s individual, small group or requested reduction would have de year. merged markets by up to 50 percent in minimis impact on the necessary (C) With respect to coverage in the States where HHS operates the risk premium increase to cover the transfers small group market, and in the large adjustment program. for issuers that would receive reduced group market if such coverage is offered (1) State requests. State requests for a transfer payments. through a SHOP in a State, for a group reduction to transfers must include: (ii) HHS may approve a reduction (i) Supporting evidence and analysis enrollment received on the first through amount that is lower than the amount demonstrating the State-specific factors the fifteenth day of any month, the requested by the State if the supporting that warrant an adjustment to more coverage effective date must be no later evidence and analysis do not fully precisely account for the differences in than the first day of the following support the requested reduction actuarial risk in the State market; month. For a group enrollment received amount. HHS will assess other relevant (ii) The adjustment percentage of up on the 16th through last day of any factors, including the premium impact to 50 percent requested for the State month, the coverage effective date must of the transfer reduction for the State individual, small group or merged be no later than the first day of the market. second following month. In either such market; and ■ case, a small employer may instead opt (iii) A justification for the reduction 6. Section 153.630 is amended by for a later effective date within a quarter requested demonstrating the State- revising paragraphs (b)(6), (8), and (9) to for which small group market rates are specific factors that warrant an read as follows: available. adjustment to more precisely account § 153.630 Data validation requirements (ii) Individual market. A health for relative risk differences in the State when HHS operates risk adjustment. individual, small group or merged insurance issuer in the individual * * * * * market must allow an individual to market, or demonstrating the requested reduction would have de minimis (b) * * * purchase health insurance coverage (6) An issuer must provide the initial during the initial and annual open impact on the necessary premium increase to cover the transfers for issuers validation auditor and the second enrollment periods described in validation auditor with all relevant § 155.410(b) and (e) of this subchapter. that would receive reduced transfer payments. source enrollment documentation, all Coverage must become effective claims and encounter data, and medical consistent with the dates described in (2) Timeframe to Submit Reduction Requests. States must submit requests record documentation from providers of § 155.410(c) and (f) of this subchapter. services to each enrollee in the (2) * * * for a reduction to transfer in the (i) A health insurance issuer in the individual, small group or merged applicable sample without unreasonable individual market must provide a market by August 1 of the year, 2 delay and in a manner that reasonably limited open enrollment period for the calendar years prior to the applicable assures confidentiality and security in triggering events described in benefit year in the form and manner transmission. Notwithstanding any § 155.420(d) of this subchapter, specified by HHS. other provision of this section, a excluding, with respect to coverage (3) Publication of Reduction Requests. qualified provider that is licensed to offered outside of an Exchange, the HHS will publish State reduction diagnose mental illness by the State and following: requests in the applicable benefit year’s that is prohibited from furnishing a HHS notice of benefit and payment complete medical record by applicable * * * * * State privacy laws concerning any (ii) In applying this paragraph (b)(2), parameters proposed rule and make the enrollee’s treatment for one or more a reference in § 155.420 (other than in supporting evidence available to the mental or behavioral health conditions § 155.420(a)(5)) of this subchapter to a public for comment. HHS will publish may furnish a signed mental or ‘‘QHP’’ is deemed to refer to a plan, a any approved State reduction requests behavioral health assessment that, to the reference to ‘‘the Exchange’’ is deemed or denied State reduction requests in the extent permissible under applicable to refer to the applicable State authority, applicable benefit year’s HHS notice of Federal and State privacy laws, should and a reference to a ‘‘qualified benefit and payment parameters final contain: The enrollee’s name; sex; date individual’’ is deemed to refer to an rule. of birth; current status of all mental or individual in the individual market. (4) HHS approval. (i) Subject to paragraph (d)(4)(ii) of this section, HHS behavioral health diagnoses; and dates * * * * * will approve State requests if HHS of service. The mental or behavioral PART 153—STANDARDS RELATED TO determines, based on the review of the health assessment should be signed by REINSURANCE, RISK CORRIDORS, information submitted as part of the the provider and submitted with an AND RISK ADJUSTMENT UNDER THE State’s request, along with other attestation that the provider is AFFORDABLE CARE ACT relevant factors, including the premium prohibited from furnishing a complete impact of the transfer reduction for the medical record by applicable State ■ 4. The authority citation for part 153 State market, and relevant public privacy laws. continues to read as follows: comments: * * * * *

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(8) The initial validation auditor must (1) The rate increase is 15 percent or § 154.301 CMS’s determinations of measure and report to the issuer and more applicable to a 12-month period Effective Rate Review Programs. HHS, in a manner and timeframe that begins on January 1, as calculated * * * * * specified by HHS, its inter-rater under paragraph (b) of this section; or (b) * * * (2) If a State intends to make the reliability rates among its reviewers. (2) The rate increase meets or exceeds information in paragraph (b)(1)(i) of this The initial validation auditor must a State-specific threshold applicable to section available to the public prior to achieve a consistency measure of at a 12-month period that begins on the date specified by the Secretary, or if least 95 percent for his or her review January 1, as calculated under it intends to make the information in outcomes, except that for validation of paragraph (b) of this section, determined paragraph (b)(1)(ii) of this section risk adjustment data for the 2015 and by the Secretary. A State-specific available to the public prior to the first 2016 benefit years, the initial validation threshold shall be based on factors day of the annual open enrollment auditor may meet an inter-rater impacting rate increases in a State to the period in the individual market for the reliability standard of 85 percent for extent that the data relating to such review outcomes. applicable calendar year, the State must State-specific factors are available by notify CMS in writing, no later than five (9) HHS may impose civil money August 1 of the preceding year. States penalties in accordance with the (5) business days prior to the date it interested in proposing a State-specific intends to make the information public, procedures set forth in § 156.805(b) threshold greater than the Federal through (e) of this subchapter if an of its intent to do so and the date it default stated in paragraph (a)(1) of this intends to make the information public. issuer of a risk adjustment covered section are required to submit a plan— proposal for approval of such threshold * * * * * (i) Fails to engage an initial validation to the Secretary by August 1 of the PART 155—EXCHANGE auditor; preceding year, in the form and manner (ii) Fails to submit the results of an ESTABLISHMENT STANDARDS AND specified by the Secretary. initial validation audit to HHS; OTHER RELATED STANDARDS (iii) Engages in misconduct or (b) A rate increase meets or exceeds UNDER THE AFFORDABLE CARE ACT substantial non-compliance with the the applicable threshold set forth in ■ risk adjustment data validation paragraph (a) of this section if the 12. The authority citation for part 155 standards and requirements applicable average increase, including premium continues to read as follows: to issuers of risk adjustment covered rating factors described in § 147.102 of Authority: Title I of the Affordable Care plans; or this subchapter, for all enrollees Act, sections 1301, 1302, 1303, 1304, 1311, (iv) Intentionally or recklessly weighted by premium volume for any 1312, 1313, 1321, 1322, 1331, 1332, 1334, misrepresents or falsifies information plan within the product meets or 1402, 1411, 1412, 1413, Pub. L. 111–148, 124 exceeds the applicable threshold. Stat. 119 (42 U.S.C. 18021–18024, 18031– that it furnishes to HHS. 18033, 18041–18042, 18051, 18054, 18071, * * * * * (c) If a rate increase that does not and 18081–18083). otherwise meet or exceed the threshold ■ 13. Section 155.106 is amended by PART 154—HEALTH INSURANCE under paragraph (b) of this section revising paragraph (c) introductory text ISSUER RATE INCREASES: meets or exceeds the threshold when to read as follows: DISCLOSURE AND REVIEW combined with a previous increase or REQUIREMENTS increases during the 12-month period § 155.106 Election to operate an Exchange after 2014. ■ preceding the date on which the rate 7. The authority citation for part 154 increase would become effective, then * * * * * continues to read as follows: the rate increase must be considered to (c) Process for State Exchanges that Authority: Section 2794 of the Public meet or exceed the threshold and is seek to utilize the Federal platform for Health Service Act (42 U.S.C. 300gg–94). subject to review under § 154.210, and select functions. States may seek ■ 8. Section 154.103 is amended by such review shall include a review of approval to operate a State Exchange revising paragraph (b) to read as follows: the aggregate rate increases during the utilizing the Federal platform for only applicable 12-month period. the individual market. A State seeking § 154.103 Applicability. approval to operate a State Exchange ■ * * * * * 10. Section 154.215 is amended by utilizing the Federal platform for the (b) Exceptions. The requirements of revising paragraph (h)(2) to read as individual market to support select this part do not apply to— follows: functions through a Federal platform (1) Grandfathered health plan § 154.215 Submission of rate filing agreement under § 155.200(f) must: coverage as defined in § 147.140 of this justification. * * * * * subchapter; * * * * * ■ 14. Section 155.200 is amended by (2) Excepted benefits as described in removing and reserving paragraphs (h) * * * section 2791(c) of the PHS Act; and (f)(2)(ii) through (iv); and revising (3) For coverage effective on or after (2) CMS will make available to the paragraph (f)(4) introductory text to read July 1, 2018, student health insurance public on its website the information as follows; coverage as defined in § 147.145 of this contained in Parts I and III of each Rate subchapter. Filing Justification that is not a trade § 155.200 Functions of an Exchange. ■ 9. Section 154.200 is revised to read secret or confidential commercial or * * * * * as follows: financial information as defined in (f) * * * HHS’s Freedom of Information Act (2) * * * § 154.200 Rate increases subject to regulations, 45 CFR 5.31(d). (ii) [Reserved] review. (iii) [Reserved] * * * * * (a) A rate increase filed in a State, or (iv) [Reserved] effective in a State that does not require ■ 11. Section 154.301 is amended by * * * * * a rate increase to be filed, is subject to revising paragraph (b)(2) to read as (4) A State Exchange on the Federal review if: follows: platform that utilizes the Federal

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platform for SHOP functions, for plan or delegated entity of the agent, broker ■ 18. Section 155.305 is amended by years beginning on or after January 1, or issuer that participates or wishes to revising paragraph (f)(4) to read as 2018, must require its QHP issuers to participate in direct enrollment. follows: make any changes to rates in accordance (b) An agent, broker, or issuer with the timeline applicable in a participating in direct enrollment must § 155.305 Eligibility standards. Federally-facilitated SHOP under satisfy the requirement to demonstrate * * * * * § 155.706(b)(6)(i)(A). A State Exchange operational readiness under paragraph (f) * * * on the Federal platform that utilizes the (a) of this section by engaging a third- (4) Compliance with filing Federal platform for SHOP functions, as party entity that meets each of the requirement. The Exchange may not set forth in paragraphs (f)(4)(i) through following standards: determine a tax filer eligible for APTC (vii) of this section, for plan years (1) Has experience conducting audits if HHS notifies the Exchange as part of beginning prior to January 1, 2018, or similar services, including experience the process described in § 155.320(c)(3) must— with relevant privacy and security that APTC were made on behalf of the standards; tax filer or either spouse if the tax filer * * * * * is a married couple for a year for which ■ 15. Section 155.210 is amended by (2) Adheres to HHS specifications for content, format, privacy, and security in tax data would be utilized for revising paragraphs (c)(2) introductory verification of household income and text and (e)(7) to read as follows: the conduct of an operational readiness review, which includes ensuring that family size in accordance with § 155.210 Navigator program standards. agents, brokers, and issuers are in § 155.320(c)(1)(i), and the tax filer or his or her spouse did not comply with the * * * * * compliance with the applicable privacy (c) * * * and security standards and other requirement to file an income tax return (2) The Exchange must include an applicable requirements; for that year as required by 26 U.S.C. entity from at least one of the following (3) Collects, stores, and shares with 6011, 6012, and implementing categories for receipt of a Navigator HHS all data related to the third-party regulations and reconcile the advance grant: entity’s audit of agents, brokers, and payments of the premium tax credit for that period. * * * * * issuers in a manner, format, and (e) * * * frequency specified by HHS until 10 * * * * * (7) In a Federally-facilitated years from the date of creation, and ■ 19. Section 155.320 is amended by— Exchange, no individual or entity shall complies with the privacy and security ■ a. Revising paragraphs (c)(3)(iii) be ineligible to operate as a Navigator standards HHS adopts for agents, introductory text, and paragraph solely because its principal place of brokers, and issuers as required in (c)(3)(iii)(A); business is outside of the Exchange accordance with § 155.260; ■ b. Adding paragraphs (c)(3)(iii)(D) service area; (4) Discloses to HHS any financial through (F); ■ * * * * * relationships between the entity and c. Revising paragraph (c)(3)(vi)(C), (D), ■ individuals who own or are employed (F) and (G); and 16. Section 155.215 is amended by ■ d. Revising paragraph (d)(4) revising paragraph (h) to read as by an agent, broker, or issuer for which it is conducting an operational readiness introductory text. follows: The revisions and additions read as review. follows: § 155.215 Standards applicable to (5) Complies with all applicable Navigators and Non-Navigator Assistance Federal and State requirements; § 155.320 Verification process related to Personnel carrying out consumer (6) Ensures, on an annual basis, that eligibility for insurance affordability assistance functions under §§ 155.205(d) programs. and (e) and 155.210 in a Federally-facilitated appropriate staff successfully complete Exchange and to Non-Navigator Assistance operational readiness review training as * * * * * Personnel funded through an Exchange established by HHS prior to conducting (c) * * * Establishment Grant. audits under paragraph (a) of this (3) * * * * * * * * section; (iii) Verification process for changes (h) Physical presence. In a Federally- (7) Permits access by the Secretary in household income. (A) Except as facilitated Exchange, no individual or and the Office of the Inspector General specified in paragraph (c)(3)(iii)(B), (C), entity shall be ineligible to operate as a or their designees in connection with and (D) of this section, if an applicant’s non-Navigator entity or as non- their right to evaluate through audit, attestation, in accordance with Navigator assistance personnel solely inspection, or other means, to the third- paragraph (c)(3)(ii)(B) of this section, because its principal place of business party entity’s books, contracts, indicates that a tax filer’s annual is outside of the Exchange service area. computers, or other electronic systems, household income has increased or is reasonably expected to increase from * * * * * relating to the third-party entity’s audits of agent’s, broker’s, or issuer’s the data described in paragraph ■ 17. Section 155.221 is revised to read obligations in accordance with Federal (c)(3)(ii)(A) of this section for the benefit as follows: standards under paragraph (a) of this year for which the applicant(s) in the § 155.221 Standards for third-parties to section until 10 years from the date of tax filer’s family are requesting coverage perform audits of agents, brokers, and creation; and and the Exchange has not verified the issuers participating in direct enrollment. (8) Complies with other minimum applicant’s MAGI-based income through (a) An agent, broker, or issuer business criteria as specified in the process specified in paragraph participating in direct enrollment must guidance by HHS. (c)(2)(ii) of this section to be within the engage a third-party entity to conduct an (c) An agent, broker or issuer may applicable Medicaid or CHIP MAGI- annual review to demonstrate engage multiple third-party entities to based income standard, the Exchange operational readiness in accordance conduct the audit under paragraph (a) of must accept the applicant’s attestation with § 155.220(c)(3)(i)(K) and with this section and each third-party entity regarding a tax filer’s annual household § 156.1230(b)(2) of this subchapter. The must satisfy the standards outlined income without further verification. third-party entity will be a downstream under paragraph (b) of this section. * * * * *

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(D) If an applicant’s attestation to of this section, indicates that a tax filer’s eligibility based on the information projected annual household income, as annual household income has increased described in paragraph (c)(3)(ii)(A) of described in paragraph (c)(3)(ii)(B) of or is reasonably expected to increase this section, notify the applicant of such this section, is greater than or equal to from the data described in paragraph determination in accordance with the 100 percent but not more than 400 (c)(3)(vi)(A) of this section to the benefit notice requirements specified in percent of the FPL for the benefit year year for which the applicant(s) in the § 155.310(g), and implement such for which coverage is requested and is tax filer’s family are requesting coverage determination in accordance with the more than a reasonable threshold above and the Exchange has not verified the effective dates specified in § 155.330(f). the annual household income computed applicant’s MAGI-based income through (G) If, at the conclusion of the period in accordance with paragraph the process specified in paragraph specified in § 155.315(f)(2)(ii), the (c)(3)(ii)(A) of this section, the data (c)(2)(ii) of this section to be within the Exchange remains unable to verify the described in paragraph (c)(3)(ii)(A) of applicable Medicaid or CHIP MAGI- applicant’s attestation for the tax filer this section indicates that projected based income standard, the Exchange and the information described in annual household income is under 100 must accept the applicant’s attestation paragraph (c)(3)(ii)(A) of this section is percent FPL, and the Exchange has not for the tax filer’s family without further unavailable, the Exchange must verified the applicant’s MAGI-based verification, unless: determine the tax filer ineligible for income through the process specified in (1) The Exchange finds that an advance payments of the premium tax paragraph (c)(2)(ii) of this section to be applicant’s attestation of a tax filer’s credit and cost-sharing reductions, within the applicable Medicaid or CHIP annual household income is not notify the applicant of such MAGI-based income standard, the reasonably compatible with other determination in accordance with the Exchange must proceed in accordance information provided by the application notice requirement specified in with § 155.315(f)(1) through (4). filer, or § 155.310(g), and discontinue any However, this paragraph (c)(3)(iii)(D) (2) The data described in paragraph advance payments of the premium tax does not apply if the applicant is a non- (c)(3)(vi)(A) of this section indicates that credit and cost-sharing reductions in citizen who is lawfully present and projected annual household income is accordance with the effective dates ineligible for Medicaid by reason of under 100 percent FPL and the specified in § 155.330(f). immigration status. For the purposes of applicant’s attestation to projected * * * * * this paragraph, a reasonable threshold is household income, as described in (d) * * * established by the Exchange in guidance paragraph (c)(3)(ii)(B) of this section, is (4) Alternate procedures. For any and approved by HHS, but must not be greater than or equal to 100 percent but benefit year for which it does not less than 10 percent, and can also not more than 400 percent of the FPL for reasonably expect to obtain sufficient include a threshold dollar amount. the benefit year for which coverage is verification data as described in (E) If, at the conclusion of the period requested and is more than a reasonable paragraphs (d)(2)(i) through (iii) of this specified in § 155.315(f)(2)(ii), the threshold above the annual household section, the Exchange must follow the Exchange remains unable to verify the income as computed using data sources procedures specified in paragraph applicant’s attestation, the Exchange described in paragraph (c)(3)(vi)(A) of (d)(4)(i) of this section or, for benefit must determine the applicant’s this section, in which case the Exchange years 2016 through 2019, the Exchange eligibility based on the information must follow the procedures specified in may follow the procedures specified in described in paragraph (c)(3)(ii)(A) of § 155.315(f)(1) through (4). The paragraph (d)(4)(ii) of this section. For this section, notify the applicant of such reasonable threshold used under this purposes of this paragraph (d)(4), the determination in accordance with the paragraph must be equal to the Exchange reasonably expects to obtain notice requirements specified in reasonable threshold established in sufficient verification data for any § 155.310(g), and implement such accordance with paragraph (c)(3)(iii)(D) benefit year when, for the benefit year, determination in accordance with the of this section. the Exchange is able to obtain data effective dates specified in § 155.330(f). (D) Decreases in annual household about enrollment in and eligibility for (F) If, at the conclusion of the period income and situations in which qualifying coverage in an eligible specified in § 155.315(f)(2)(ii), the electronic data is unavailable. If employer-sponsored plan from at least Exchange remains unable to verify the electronic data are unavailable or an one electronic data source that is applicant’s attestation and the applicant’s attestation to projected available to the Exchange and that has information described in paragraph annual household income, as described been approved by HHS, based on (c)(3)(ii)(A) of this section is in paragraph (c)(3)(ii)(B) of this section, evidence showing that the data source is unavailable, the Exchange must is more than a reasonable threshold sufficiently current, accurate, and determine the tax filer ineligible for below the annual household income as minimizes administrative burden, as advance payments of the premium tax computed using data sources described described under paragraph (d)(2)(i) of credit and cost-sharing reductions, in paragraphs (c)(3)(vi)(A) of this this section. notify the applicant of such section, the Exchange must follow the * * * * * determination in accordance with the procedures specified in § 155.315(f)(1) ■ 20. Section 155.420 is amended by: notice requirements specified in through (4). The reasonable threshold ■ a. Revising paragraphs (a)(4)(iii), (a)(5) § 155.310(g), and discontinue any used under this paragraph must be and (b)(2)(i); advance payments of the premium tax equal to the reasonable threshold ■ b. Removing paragraph (b)(2)(v); credit and cost-sharing reductions in established in accordance with ■ c. Redesignating paragraph (b)(2)(vi) accordance with the effective dates paragraph (c)(3)(vi) of this section. as paragraph (b)(2)(v); specified in § 155.330(f). * * * * * ■ d. Revising paragraph (d)(1)(iii); and * * * * * (F) If, at the conclusion of the period ■ e. Revising paragraph (d)(10)(i). (vi) * * * specified in § 155.315(f)(2)(ii), the The revisions read as follows: (C) Increases in annual household Exchange remains unable to verify the income. If an applicant’s attestation, in applicant’s attestation, the Exchange § 155.420 Special enrollment periods. accordance with paragraph (c)(3)(ii)(B) must determine the applicant’s (a) * * *

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(4) * * * paragraph (b)(1) of this section. If the at the option of the QHP issuer, on a (iii) For the other triggering events Exchange permits the qualified date on or after the termination is specified in paragraph (d) of this individual or enrollee to elect a requested by the enrollee that is less section, except for paragraphs (d)(2)(i), coverage effective date of either the first than 14 days after the termination is (d)(4), (d)(6)(i) and (ii) of this section for of the month following the date of plan requested by the enrollee, if the enrollee becoming newly eligible for CSRs, selection or in accordance with requests an earlier termination date; or (d)(8), (9), (10) and (12) of this section: paragraph (b)(1) of this section, the (v) At the option of the Exchange, for (A) If an enrollee qualifies for a Exchange must ensure coverage is an individual who is newly determined special enrollment period, the Exchange effective on the date duly selected by eligible for Medicaid, CHIP, or the Basic must allow the enrollee and his or her the qualified individual or enrollee. Health Program, if a Basic Health dependents to change to another QHP * * * * * Program is operating in the service area within the same level of coverage (or (d) * * * of the Exchange, the day before the one metal level higher or lower, if no (1) * * * enrollee’s date of eligibility for such QHP is available), as outlined in (iii) Loses pregnancy-related coverage Medicaid, CHIP, or the Basic Health § 156.140(b) of this subchapter; or described under section Program. (B) If a dependent qualifies for a 1902(a)(10)(A)(i)(IV) and * * * * * special enrollment period, and an (a)(10)(A)(ii)(IX) of the Act (42 U.S.C. ■ enrollee is adding the dependent to his 22. Section 155.500 is amended by 1396a(a)(10)(A)(i)(IV), (a)(10)(A)(ii)(IX)) or her QHP, the Exchange must allow revising the definitions of ‘‘Appeal or loses access to health care services the enrollee to add the dependent to his request’’ and ‘‘Appeals entity’’ to read as through coverage provided to a pregnant or her current QHP; or, if the QHP’s follows: woman’s unborn child, based on the business rules do not allow the § 155.500 Definitions. dependent to enroll, the Exchange must definition of a child in 42 CFR 457.10. allow the enrollee and his or her The date of the loss of coverage is the * * * * * dependents to change to another QHP last day the qualified individual would Appeal request means a clear within the same level of coverage (or have pregnancy-related coverage or expression, either orally or in writing, one metal level higher or lower, if no access to health care services through by an applicant, enrollee, employer, or such QHP is available), as outlined in the unborn child coverage; or small business employer or employee to § 156.140(b) of this subchapter, or enroll * * * * * have any eligibility determination or the new qualified individual in a (10) * * * redetermination contained in a notice separate QHP. (i) Is a victim of domestic abuse or issued in accordance with § 155.310(g), (5) Prior coverage requirement. spousal abandonment as defined by 26 § 155.330(e)(1)(ii), § 155.335(h)(1)(ii), Qualified individuals who are required CFR 1.36B–2 or a dependent or § 155.610(i), § 155.715(e) or (f), or to demonstrate coverage in the 60 days unmarried victim within a household, is § 155.716(e) reviewed by an appeals prior to a qualifying event can either enrolled in minimum essential entity. demonstrate that they had minimum coverage, and sought to enroll in Appeals entity means a body essential coverage as described in 26 coverage separate from the perpetrator designated to hear appeals of eligibility CFR 1.5000A–1(b) for 1 or more days of the abuse or abandonment; or determinations or redeterminations during the 60 days preceding the date of * * * * * contained in notices issued in accordance with § 155.310(g), the qualifying event; lived in a foreign ■ 21. Section 155.430 is amended by: § 155.330(e)(1)(ii), § 155.335(h)(1)(ii), country or in a United States territory ■ a. Revising paragraph (d)(2)(ii); § 155.610(i), § 155.715(e) and (f), or for 1 or more days during the 60 days ■ b. Redesignating paragraphs (d)(2)(iii), § 155.716(e). preceding the date of the qualifying (d)(2)(iv) and (d)(2)(v) as paragraphs event; are an Indian as defined by (d)(2)(iv), (d)(2)(v), and (d)(2)(vi), * * * * * section 4 of the Indian Health Care respectively; ■ 23. Section 155.605 is amended by Improvement Act; or lived for 1 or more ■ c. Adding new paragraph (d)(2)(iii); revising paragraph (d)(2)(iv) to read as days during the 60 days preceding the and follows: qualifying event or during their most ■ d. Revising newly redesignated recent preceding enrollment period, as § 155.605 Eligibility standards for paragraphs (d)(2)(iv), and (v). exemptions. specified in §§ 155.410 and 155.420, in The revisions and additions read as a service area where no qualified health follows: * * * * * plan was available through the (d) * * * Exchange. § 155.430 Termination of Exchange (2) * * * (b) * * * enrollment or coverage. (iv) For an individual who is (2) * * * * * * * * ineligible to purchase coverage under an (i) In the case of birth, adoption, (d) * * * eligible employer-sponsored plan, the placement for adoption, placement in (2) * * * Exchange determines the required foster care, or child support or other (ii) If the enrollee does not provide contribution for coverage in accordance court order as described in paragraph reasonable notice, fourteen days after with section 5000A(e)(1)(B)(ii) of the (d)(2)(i) of this section, the Exchange the termination is requested by the Code, inclusive of all members of the must ensure that coverage is effective enrollee; or family, as defined in 26 CFR 1.36B–1(d), for a qualified individual or enrollee on (iii) At the option of the Exchange, on who have not otherwise been granted an the date of birth, adoption, placement the date on which the termination is exemption through the Exchange and for adoption, placement in foster care, requested by the enrollee, or on another who are not treated as eligible to or effective date of court order; or it may prospective date selected by the purchase coverage under an eligible permit the qualified individual or enrollee; or employer-sponsored plan, in accordance enrollee to elect a coverage effective (iv) If an Exchange does not require an with paragraph (d)(4)(ii) of this section. date of the first of the month following earlier termination date in accordance If there is not a bronze level plan offered plan selection; or in accordance with with paragraph (d)(2)(iii) of this section, through the Exchange in the

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individual’s county, the Exchange must required functions of an Exchange qualified employees a choice of all use the annual premium for the lowest described in this subpart and in QHPs offered through the SHOP by a cost Exchange metal level plan, subparts C, E, K, and M of this part, single issuer across all available levels excluding catastrophic coverage, except: of coverage, as described in section available in the individual market (1) Requirements related to individual 1302(d)(1) of the Affordable Care Act through the Exchange in the State in the eligibility determinations in subpart D and implemented in § 156.140(b) of this county in which the individual resides of this part; subchapter. A State with a Federally- to determine whether coverage exceeds (2) Requirements related to facilitated SHOP may recommend that the affordability threshold specified in enrollment of qualified individuals the Federally-facilitated SHOP not make section 5000A(e)(1) of the Code; and described in subpart E of this part; this additional option available in that * * * * * (3) The requirement to issue State, by submitting a letter to HHS in certificates of exemption in accordance ■ 24. Section 155.610 is amended by advance of the annual QHP certification with § 155.200(b); and application deadline, by a date to be revising paragraph (h)(2) to read as (4) Requirements related to the follows: established by HHS. The State’s letter payment of premiums by individuals, must describe and justify the State’s § 155.610 Eligibility process for Indian tribes, tribal organizations and recommendation, based on the exemptions. urban Indian organizations under anticipated impact this additional * * * * * § 155.240. option would have on the small group (h) * * * (b) Unique functions of a SHOP. The market and consumers. (2) The Exchange will only accept an SHOP must also provide the following (v) A SHOP may also provide a application for an exemption described unique functions: qualified employer with a choice of a in § 155.605(d)(1) during one of the 3 (1) Enrollment and eligibility third method to make stand-alone calendar years after the month or functions. The SHOP must adhere to the dental plans available to qualified months during which the applicant requirements outlined in subpart H. employees by offering its qualified attests that the hardship occurred. (2) Employer choice requirements. employees a choice of all stand-alone The SHOP must allow a qualified * * * * * dental plans offered through the SHOP employer to select a level of coverage as by a single issuer. A State with a ■ 25. Section 155.700 is amended by described in section 1302(d)(1) of the revising paragraph (a) to read as follows: Federally-facilitated SHOP may Affordable Care Act, in which all QHPs recommend that the Federally- within that level are made available to § 155.700 Standards for the establishment facilitated SHOP not make this of a SHOP. the qualified employees of the additional option available in that State, employer. by submitting a letter to HHS in advance (a) General requirement. (1) For plan (3) SHOP options with respect to of the annual QHP certification years beginning before January 1, 2018, employer choice requirements. (i) A application deadline, by a date to be an Exchange must provide for the SHOP: established by HHS. The State’s letter establishment of a SHOP that meets the (A) Must allow an employer to make must describe and justify the State’s requirements of this subpart and is available to qualified employees all recommendation, based on the designed to assist qualified employers QHPs at the level of coverage selected anticipated impact this additional and facilitate the enrollment of qualified by the employer as described in option would have on the small group employees into qualified health plans. paragraph (b)(2) of this section, and (2) For plan years beginning on or (B) May allow an employer to make market and consumers. after January 1, 2018, an Exchange must one or more QHPs available to qualified (vi) States operating a State Exchange provide for the establishment of a SHOP employees by a method other than the utilizing the Federal platform for SHOP that meets the requirements of this method described in paragraph (b)(2) of enrollment functions will have the same subpart and is designed to assist this section. employer choice models available as qualified employers in facilitating the (ii) A Federally-facilitated SHOP will States with a Federally-facilitated enrollment of their employees in provide a qualified employer a choice of SHOP, except that a State with a State qualified health plans. two methods to make QHPs available to Exchange utilizing the Federal platform * * * * * qualified employees: for SHOP enrollment functions may decide against offering the employer ■ 26. Section 155.705 is amended by (A) The employer may choose a level choice models specified in paragraphs revising the section heading and adding of coverage as described in paragraph (b)(3)(iv) and (v) of this section in that paragraph (e) to read as follows: (b)(2) of this section, or (B) The employer may choose a single State, provided that the State notifies § 155.705 Functions of a SHOP for plan QHP. HHS of that decision in advance of the years beginning prior to January 1, 2018. (iii) A SHOP may, and a Federally- annual QHP certification application * * * * * facilitated SHOP will provide a deadline, by a date to be established by (e) Applicability date. The provisions qualified employer a choice of two HHS. of this section apply for plan years methods to make stand-alone dental (4) Continuation of Coverage. The beginning prior to January 1, 2018. plans available to qualified employees: SHOP may, upon an election by a Section 155.706 is applicable for plan (A) The employer may choose to make qualified employer, enter into an years beginning on or after January 1, available a single stand-alone dental agreement with a qualified employer to 2018. plan. facilitate the administration of ■ 27. Section 155.706 is added to read (B) The employer may choose to make continuation coverage by collecting as follows: available all stand-alone dental plans premiums for continuation coverage offered through a SHOP. enrolled in through the SHOP directly § 155.706 Functions of a SHOP for plan (iv) A SHOP may also provide a from a person enrolled in continuation years beginning on or after January 1, 2018. qualified employer with a choice of a coverage through the SHOP consistent (a) Exchange functions that apply to third method to make QHPs available to with applicable law and the terms of the SHOP. The SHOP must carry out all the qualified employees by offering its group health plan, and remitting

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premium payments for this coverage to employees accepting coverage offered § 155.716 Eligibility determination process QHP issuers. by a qualified employer plus the for SHOP for plan years beginning on or (5) QHP Certification. With respect to number of full-time employees who, at after January 1, 2018. certification of QHPs in the small group the time the employer submits the (a) General requirement. The SHOP market, the SHOP must ensure each SHOP group enrollment, are enrolled in must determine whether an employer QHP meets the requirements specified coverage through another group health requesting a determination of eligibility in § 156.285 of this subchapter. plan, governmental coverage (such as to participate in a SHOP is eligible in (6) Rates and rate changes. The SHOP Medicare, Medicaid, or TRICARE), accordance with the requirements of must— coverage sold through the individual § 155.710. (i) Require all QHP issuers to make market, or in other minimum essential (b) Applications. The SHOP must any change to rates at a uniform time coverage, divided by the number of full- accept a SHOP single employer that is no more frequently than time employees offered coverage. application form from employers, in quarterly. accordance with the relevant standards (ii) Notwithstanding paragraphs (A) In a Federally-facilitated SHOP, of § 155.730. (b)(10)(i) of this section, a Federally- rates may be updated quarterly with (c) Verification of eligibility. For the facilitated SHOP may utilize a different effective dates of January 1, April 1, July purpose of verifying employer minimum participation rate in a State if 1, or October 1 of each calendar year. eligibility, the SHOP— there is evidence that a State law sets a The updated rates must be submitted to (1) May establish, in addition to or in minimum participation rate or that a HHS at least 60 days in advance of the lieu of reliance on the application, higher or lower minimum participation effective date of the rates. additional methods to verify the rate is customarily used by the majority (B) [Reserved] information provided by the applicant (ii) Prohibit all QHP issuers from of QHP issuers in that State for products on the applicable application; varying rates for a qualified employer in the State’s small group market (2) Must collect only the minimum during the employer’s plan year. outside the SHOP. information necessary for verification of (7) QHP availability in merged (11) Premium calculator. In the markets. If a State merges the individual eligibility in accordance with the SHOP, the premium calculator eligibility standards described in market and the small group market risk described in § 155.205(b)(6) must pools in accordance with section § 155.710; and facilitate the comparison of available (3) May not perform individual 1312(c)(3) of the Affordable Care Act, QHPs. the SHOP may permit employer groups market Exchange eligibility to enroll in any QHP meeting level of (c) Coordination with individual determinations or verifications coverage requirements described in market Exchange for eligibility described in subpart D of this part. section 1302(d) of the Affordable Care determinations. A SHOP that collects (d) Eligibility adjustment period. Act. employee eligibility or enrollment data When the information submitted on the (8) QHP availability in unmerged must provide data related to eligibility SHOP single employer application is markets. If a State does not merge the and enrollment of a qualified employee inconsistent with information collected individual and small group market risk to the individual market Exchange that from third-party data sources through pools, the SHOP must permit employer corresponds to the service area of the the verification process described in groups to enroll only in QHPs in the SHOP, unless the SHOP is operated paragraph (c)(1) of this section or small group market. pursuant to § 155.100(a)(2). otherwise received by the SHOP, the SHOP must— (9) SHOP expansion to large group (d) Duties of Navigators in the SHOP. (1) Make a reasonable effort to market. If a State elects to expand the In States that have elected to operate identify and address the causes of such SHOP to the large group market, a SHOP only a SHOP pursuant to inconsistency, including through must allow issuers of health insurance § 155.100(a)(2), at State option and if typographical or other clerical errors; coverage in the large group market in State law permits the Navigator duties (2) Notify the employer of the the State to offer QHPs in such market described in § 155.210(e)(3) and (4) may inconsistency; through a SHOP beginning in 2017 be fulfilled through referrals to agents (3) Provide the employer with a provided that a large employer meets and brokers. the qualified employer requirements period of 30 days from the date on other than that it be a small employer. (e) Applicability date. The provisions which the notice described in paragraph (10) Participation rules. Subject to of this section apply for plan years (d)(2) of this section is sent to the § 147.104 of this subchapter, the SHOP beginning on or after January 1, 2018. employer to either present satisfactory may authorize a uniform group ■ 28. Section 155.715 is amended by documentary evidence to support the participation rate for the offering of revising the section heading and adding employer’s application, or resolve the health insurance coverage in the SHOP, paragraph (h) to read as follows: inconsistency; and which must be a single, uniform rate (4) If, after the 30-day period that applies to all groups and issuers in § 155.715 Eligibility determination process described in paragraph (d)(2) of this the SHOP. If the SHOP authorizes a for SHOP for plan years beginning prior to section, the SHOP has not received minimum participation rate, such rate January 1, 2018. satisfactory documentary evidence, the must be based on the rate of employee * * * * * SHOP must— (i) Notify the employer of its denial or participation in the SHOP, not on the (h) Applicability date. The provisions termination of eligibility in accordance rate of employee participation in any of this section apply for plan years with paragraph (e) of this section and of particular QHP or QHPs of any beginning prior to January 1, 2018. the employer’s right to appeal such particular issuer. Section 155.716 is applicable for plan (i) Subject to § 147.104 of this determination; and years beginning on or after January 1, subchapter, a Federally-facilitated (ii) If the employer was enrolled 2018. SHOP must use a minimum pending the confirmation or verification participation rate of 70 percent, ■ 29. Section 155.716 is added to read of eligibility information, discontinue calculated as the number of full-time as follows: the employer’s participation in the

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SHOP at the end of the month following § 155.726 Enrollment periods under SHOP (5) The effective dates of coverage for the month in which the notice is sent. for plan years beginning on or after January special enrollment periods are (e) Notification of employer eligibility. 1, 2018. determined using the provisions of The SHOP must provide an employer (a) General requirements. The SHOP § 155.420(b). requesting eligibility to purchase must ensure that issuers offering QHPs (6) Loss of minimum essential coverage through the SHOP with a through the SHOP adhere to applicable coverage is determined using the notice of approval or denial or enrollment periods, including special provisions of § 155.420(e). termination of eligibility and the enrollment periods. (d) Limitation. Qualified employees employer’s right to appeal such (b) Rolling enrollment in the SHOP. will not be able to enroll unless the eligibility determination. The SHOP must permit a qualified employer group meets any applicable (f) Validity of Eligibility employer to purchase coverage for its minimum participation rate Determination. An employer’s small group at any point during the implemented under § 155.706(b)(10). determination of eligibility to year. The employer’s plan year must (e) Applicability date. The provisions participate in SHOP remains valid until consist of the 12-month period of this section apply for plan years the employer makes a change that could beginning with the qualified employer’s beginning on or after January 1, 2018. end its eligibility under § 155.710(b) or effective date of coverage, unless the ■ 34. Section 155.730 is amended by withdraws from participation in the plan is issued in a State that has elected revising the section heading and adding SHOP. to merge its individual and small group paragraph (h) to read as follows: (g) Applicability date. The provisions risk pools under section 1312(c)(3) of of this section apply for plan years the Affordable Care Act, in which case § 155.730 Application standards for SHOP beginning on or after January 1, 2018. the plan year will end on December 31 for plan year beginning prior to January 1, ■ 30. Section 155.720 is amended by of the calendar year in which coverage 2018. revising the section heading and adding first became effective. * * * * * paragraph (j) to read as follows: (c) Special enrollment periods. (1) The (h) Applicability date. The provisions SHOP must ensure that issuers offering of this section apply for plan years § 155.720 Enrollment of employees into QHPs through the SHOP provide special beginning prior to January 1, 2018. QHPs under SHOP for plan years beginning prior to January 1, 2018. enrollment periods consistent with the Section 155.731 is applicable for plan section, during which certain qualified years beginning on or after January 1, * * * * * employees or dependents of qualified 2018. (j) Applicability date. The provisions employees may enroll in QHPs and ■ of this section apply for plan years 35. Section 155.731 is added to read beginning prior to January 1, 2018. enrollees may change QHPs. as follows: (2) The SHOP must ensure that Section 155.721 is applicable for plan issuers offering QHPs through a SHOP § 155.731 Application standards for SHOP years beginning on or after January 1, provide a special enrollment period for for plan years beginning on or after January 2018. a qualified employee or a dependent of 1, 2018. ■ 31. Section 155.721 is added to read a qualified employee who; (a) General requirements. Application as follows: (i) Experiences an event described in forms used by the SHOP must meet the § 155.721 Record retention and IRS § 155.420(d)(1) (other than paragraph requirements set forth in this section. Reporting for plan years beginning on or (d)(1)(ii)), or experiences an event (b) Single employer application. The after January 1, 2018. described in § 155.420(d)(2), (4), (5), (7), SHOP must use a single application to (a) Records. The SHOP must receive (8), (9), (10), (11), or (12); determine employer eligibility. Such and maintain for at least 10 years (ii) Loses eligibility for coverage application must collect the following— records of qualified employers under a Medicaid plan under title XIX (1) Employer name and address of participating in the SHOP. of the Social Security Act or a State employer’s locations; (b) Reporting requirement for tax child health plan under title XXI of the (2) Information sufficient to confirm administration purposes. The SHOP Social Security Act; or the employer is a small employer; must, at the request of the IRS, report (iii) Becomes eligible for assistance, (3) Employer Identification Number information to the IRS about employer with respect to coverage under a SHOP, (EIN); and eligibility to participate in SHOP under such Medicaid plan or a State (4) Information sufficient to confirm coverage. child health plan (including any waiver that the employer is offering, at a (c) Applicability date. The provisions or demonstration project conducted minimum, all full-time employees of this section apply for plan years under or in relation to such a plan). coverage in a QHP through a SHOP. beginning on or after January 1, 2018. (3) A qualified employee or (c) Model application. The SHOP may ■ 32. Section 155.725 is amended by dependent of a qualified employee who use the model single employer revising the section heading and adding experiences a qualifying event described application provided by HHS. paragraph (l) to read as follows: in paragraph (j)(2) of this section has: (d) Alternative employer application. (i) Thirty (30) days from the date of The SHOP may use an alternative § 155.725 Enrollment periods under SHOP a triggering event described in application if such application is for plan years beginning prior to January 1, paragraph (c)(2)(i) of this section to approved by HHS and collects the 2018. select a QHP through the SHOP; and information described in paragraph (b). * * * * * (ii) Sixty (60) days from the date of a (e) Filing. The SHOP must: (l) Applicability date. The provisions triggering event described in paragraph (1) Accept applications from SHOP of this section apply for plan years (c)(2)(ii) or (iii) of this section to select application filers; and beginning prior to January 1, 2018. a QHP through the SHOP; (2) Provide the tools to file an Section 155.726 is applicable for plan (4) A dependent of a qualified employer eligibility application via an years beginning on or after January 1, employee is not eligible for a special internet website. 2018. enrollment period if the employer does (f) Additional safeguards. (1) The ■ 33. Section 155.726 is added to read not extend the offer of coverage to SHOP may not provide to the employer as follows: dependents. any information collected on an

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employee application with respect to (2) A failure by the SHOP to provide (g) Transmittal and receipt of records. spouses or dependents other than the a timely eligibility determination or a (1) Upon receipt of a valid appeal name, address, and birth date of the timely notice of an eligibility request under this section, or upon spouse or dependent. determination in accordance with receipt of the notice under paragraph (2) The SHOP is not permitted to § 155.716(e). (f)(2) of this section, the SHOP must collect information on the single (d) Appeals notice requirement. promptly transmit, via secure electronic employer or on an employee application Notices of the right to appeal a denial interface, to the appeals entity— unless that information is necessary to of eligibility under § 155.716(e) must be (i) The appeal request, if the appeal determine SHOP eligibility or effectuate written and include— request was initially made to the SHOP; enrollment through the SHOP. (1) The reason for the denial or and (g) Applicability date. The provisions termination of eligibility, including a (ii) The eligibility record of the of this section apply for plan years citation to the applicable regulations; employer that is appealing. beginning on or after January 1, 2018. and (2) The appeals entity must promptly ■ 36. Section 155.735 is amended by (2) The procedure by which the confirm receipt of records transmitted revising the section heading and adding employer may request an appeal of the pursuant to paragraph (g)(1) of this paragraph (h) to read as follows: denial or termination of eligibility. section to the SHOP that transmitted the (e) Appeal request. The SHOP and records. § 155.735 Termination of SHOP enrollment appeals entity must— (h) Dismissal of appeal. The appeals or coverage for plan years beginning prior (1) Allow an employer to request an entity— to January 1, 2018. appeal within 90 days from the date of (1) Must dismiss an appeal if the * * * * * the notice of denial or termination of employer that is appealing— (h) Applicability date. The provisions eligibility to— (i) Withdraws the request in of this section apply for plan years (i) The SHOP or the appeals entity; or accordance with the standards set forth beginning before January 1, 2018. (ii) HHS, if no State Exchange that in § 155.530(a)(1); or ■ 37. Section 155.740 is amended by provides for establishment of a SHOP (ii) Fails to submit an appeal request revising the section heading and adding has been established; meeting the standards specified in paragraph (p) to read as follows: (2) Accept appeal requests submitted paragraph (e) of this section. through any of the methods described in (2) Must provide timely notice to the § 155.740 SHOP employer and employee § 155.520(a)(1); employer that is appealing of the eligibility appeals requirements for plan (3) Comply with the requirements of dismissal of the appeal request, years beginning prior to January 1, 2018. § 155.520(a)(2) and (3); and including the reason for dismissal, and * * * * * (4) Consider an appeal request valid if must notify the SHOP of the dismissal. (p) Applicability date. The provisions it is submitted in accordance with (3) May vacate a dismissal if the of this section apply for plan years paragraph (e)(1) of this section. employer makes a written request beginning prior to January 1, 2018. (f) Notice of appeal request. (1) Upon within 30 days of the date of the notice Section 155.741 is applicable for plan receipt of a valid appeal request, the of dismissal showing good cause why years beginning on or after January 1, appeals entity must— the dismissal should be vacated. 2018. (i) Send timely acknowledgement to (i) Procedural rights of the employer. ■ 38. Section 155.741 is added to the employer of the receipt of the appeal The appeals entity must provide the subpart H to read as follows: request, including— employer the opportunity to submit (A) An explanation of the appeals relevant evidence for review of the § 155.741 SHOP employer and employee process; and eligibility determination. eligibility appeals requirements for plan (B) Instructions for submitting (j) Adjudication of SHOP appeals. year beginning on or after January 1, 2018. additional evidence for consideration by SHOP appeals must— (a) Definitions. The definitions in the appeals entity. (1) Comply with the standards set §§ 155.20, 155.300, and 155.500 apply (ii) Promptly notify the SHOP of the forth in § 155.555(i)(1) and (3); and to this section. appeal, if the appeal request was not (2) Consider the information used to (b) General requirements. (1) A State, initially made to the SHOP. determine the employer’s eligibility as establishing an Exchange that provides (2) Upon receipt of an appeal request well as any additional relevant evidence for the establishment of a SHOP that is not valid because it fails to meet submitted during the course of the pursuant to § 155.100 must provide an the requirements of this section, the appeal by the employer or employee. eligibility appeals process for the SHOP. appeals entity must— (k) Appeal decisions. Appeal Where a State has not established an (i) Promptly and without undue decisions must— Exchange that provides for the delay, send written notice to the (1) Be based solely on— establishment of a SHOP pursuant to employer that is appealing that— (i) The evidence referenced in § 155.100, HHS will provide an (A) The appeal request has not been paragraph (j)(2) of this section; eligibility appeals process for the SHOP accepted, (ii) The eligibility requirements for that meets the requirements of this (B) The nature of the defect in the the SHOP under § 155.710(b), as section and the requirements in appeal request; and applicable. paragraph (b)(2) of this section. (C) An explanation that the employer (2) Comply with the standards set (2) The appeals entity must conduct may cure the defect and resubmit the forth in § 155.545(a)(2) through (5) appeals in accordance with the appeal request if it meets the timeliness (3) Be effective as follows: requirements established in this section requirements of paragraph (e) of this (i) If an employer is found eligible and §§ 155.505(e) through (h) and section, or within a reasonable under the decision, then at the 155.510(a)(1) and (2) and (c). timeframe established by the appeals employer’s option, the effective date of (c) Employer right to appeal. An entity. coverage or enrollment through the employer may appeal— (ii) Treat as valid an amended appeal SHOP under the decision can either be (1) A notice of denial or termination request that meets the requirements of made retroactive to the effective date of of eligibility under § 155.716(e); or this section. coverage or enrollment through the

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SHOP that the employer would have State may change its EHB-benchmark women, children, persons with had if the employer had been correctly plan by: disabilities, and other groups; and determined eligible, or prospective to (1) Selecting the EHB-benchmark plan (v) Not include discriminatory benefit the first day of the month following the that another State used for the 2017 plan designs that contravene the non- date of the notice of the appeal decision. year under § 156.100 and § 156.110; discrimination standards defined in (ii) If the employer is found ineligible (2) Replacing one or more categories § 156.125. under the decision, then the appeal of EHBs established at § 156.110(a) in (c) The State must provide reasonable decision is effective as of the date of the the State’s EHB-benchmark plan used public notice and an opportunity for notice of the appeal decision. for the 2017 plan year with the same public comment on the State’s selection (l) Notice of appeal decision. The category or categories of EHB from the of an EHB-benchmark plan that includes appeals entity must issue written notice EHB-benchmark plan that another State posting a notice on its opportunity for of the appeal decision to the employer used for the 2017 plan year under public comment with associated and to the SHOP within 90 days of the § 156.100 and § 156.110; or information on a relevant State website. date the appeal request is received. (3) Otherwise selecting a set of (d) A State must notify HHS of the (m) Implementation of SHOP appeal benefits that would become the State’s selection of a new EHB-benchmark plan decisions. The SHOP must promptly EHB-benchmark plan. by a date to be determined by HHS for implement the appeal decision upon (b) A State’s EHB-benchmark plan each applicable plan year. receiving the notice under paragraph (l) must: (1) If the State does not make a (1) EHB coverage. Provide coverage of of this section. selection by the annual selection date, items and services for at least the (n) Appeal record. Subject to the or its benchmark plan selection does not categories of benefits at § 156.110(a), requirements of § 155.550, the appeal meet the requirements of this section including an appropriate balance of record must be accessible to the and section 1302 of the PPACA, the coverage for these categories of benefits. employer in a convenient format and at State’s EHB-benchmark plan for the (2) Scope of benefits. (i) Provide a applicable plan year will be that State’s a convenient time. scope of benefits equal to, or greater (o) Applicability date. The provisions EHB-benchmark plan applicable for the than, to the extent any supplementation prior year. of this section apply for plan years is required to provide coverage within beginning on or after January 1, 2018. (2) [Reserved] each EHB category at § 156.110(a), the (e) A State changing its EHB- PART 156—HEALTH INSURANCE scope of benefits provided under a benchmark plan under this section must ISSUER STANDARDS UNDER THE typical employer plan, defined as either: submit documents in a format and (A) One of the selecting State’s 10 AFFORDABLE CARE ACT, INCLUDING manner specified by HHS by a date base-benchmark plan options STANDARDS RELATED TO determined by HHS. These must established at § 156.100, and available EXCHANGES include: for the selecting State’s selection for the (1) A document confirming that the ■ 39. The authority citation for part 156 2017 plan year; or State’s EHB-benchmark plan definition (B) The largest health insurance plan continues to read as follows: complies with the requirements under by enrollment within one of the five paragraphs (a), (b) and (c) of this Authority: Title I of the Affordable Care largest large group health insurance Act, sections 1301–1304, 1311–1313, 1321– section, including information on which products by enrollment in the State, as selection option under paragraph (a) of 1322, 1324, 1334, 1342–1343, 1401–1402, product and plan are defined at Pub. L. 111–148, 124 Stat. 119 (42 U.S.C. this section the State is using, and § 144.103 of this subchapter, provided 18021–18024, 18031–18032, 18041–18042, whether the State is using another 18044, 18054, 18061, 18063, 18071, 18082, that: State’s EHB-benchmark plan; (1) The product has at least 10 percent 26 U.S.C. 36B, and 31 U.S.C. 9701). (2) An actuarial certification and an of the total enrollment of the five largest associated actuarial report from an ■ 40. Section 156.100 is amended by large group health insurance products in actuary, who is a member of the revising the section heading and the the State; introductory text and by adding (2) The plan provides minimum American Academy of Actuaries, in paragraph (d) to read as follows: value, as defined under § 156.145; accordance with generally accepted (3) The benefits are not excepted actuarial principles and methodologies, § 156.100 State selection of benchmark benefits, as established under that affirms: plan for plan years beginning prior to (i) That the State’s EHB-benchmark January 1, 2020. § 146.145(b), and § 148.220 of this subchapter; and plan provides a scope of benefits that is For plan years beginning before (4) The benefits in the plan are from equal to, or greater than, to the extent January 1, 2020, each State may identify a plan year beginning after December any supplementation is required to a base-benchmark plan according to the 31, 2013. provide coverage within each EHB selection criteria described below: (ii) Not exceed the generosity of the category at § 156.110(a), the scope of * * * * * most generous among a set of benefits provided under a typical (d) Applicability date: For plan years comparison plans, including: employer plan, as defined at (b)(2)(i) of beginning on or after January 1, 2020, (A) The State’s EHB-benchmark plan this section; and § 156.111 applies in place of this used for the 2017 plan year, and (ii) That the State’s EHB-benchmark section. (B) Any of the State’s base-benchmark plan does not exceed the generosity of ■ 41. Section 156.111 is added to plan options for the 2017 plan year the most generous among the plans Subpart B to read as follows: described in § 156.100(a)(1), listed in paragraphs (b)(2)(ii)(A) and (B) supplemented as necessary under of this section. § 156.111 State selection of EHB- § 156.110. (3) The State’s EHB-benchmark plan benchmark plan for plan years beginning (iii) Not have benefits unduly document that reflects the benefits and on or after January 1, 2020. weighted towards any of the categories limitations, including medical (a) Subject to paragraphs (b), (c), (d) of benefits at § 156.110(a); management requirements, a schedule and (e) of this section, for plan years (iv) Provide benefits for diverse of benefits and, if the State is selecting beginning on or after January 1, 2020, a segments of the population, including its EHB-benchmark plan using the

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option in paragraph (a)(3) of this (2) Must have the plan’s actuarial and process for enrolling qualified section, a formulary drug list in a format value of coverage for pediatric dental employers and employer group and manner specified by HHS; and essential health benefits certified by a members. (4) Other documentation specified by member of the American Academy of (c) Enrollment process for the SHOP. HHS, which is necessary to Actuaries using generally accepted A QHP issuer offering a QHP through operationalize the State’s EHB- actuarial principles and reported to the the SHOP must: benchmark plan. Exchange. (1) Provide new enrollees with the ■ 42. Section 156.115 is amended by * * * * * enrollment information package as revising paragraph (b) to read as follows: ■ described in § 156.265(e); and 44. Section 156.200 is amended by (2) Enroll all qualified employees § 156.115 Provision of EHB. revising paragraph (b)(2) to read as consistent with the plan year of the * * * * * follows: applicable qualified employer. (b) An issuer of a plan offering EHB § 156.200 QHP issuer participation (d) Participation rules. QHP issuers may substitute benefits for those standards. offering a QHP through the SHOP may impose group participation rules for the provided in the EHB-benchmark plan * * * * * under the following conditions— (b) * * * offering of health insurance coverage in (1) The issuer substitutes a benefit (2) Comply with Exchange processes, connection with a QHP only if and to that: procedures, and requirements set forth the extent authorized by the SHOP in (i) Is actuarially equivalent to the in accordance with subpart K of part accordance with § 155.706 of this benefit that is being replaced as 155 of this subchapter and, in the small subchapter. determined in paragraph (b)(4) of this (e) Employer choice. QHP issuers group market, §§ 155.705 and 155.706 of section; and offering a QHP through the SHOP must this subchapter; (ii) Is not a prescription drug benefit. accept enrollments from groups in (2) An issuer may substitute a benefit * * * * * accordance with the employer choice under this paragraph: ■ 45. Section 156.285 is amended by policies applicable to the SHOP under (i) Within the same EHB category, revising the section heading and adding § 155.706(b)(3) of this subchapter. unless prohibited by applicable State paragraph (f) to read as follows: (f) Identification of SHOP requirements; and enrollments. QHP issuers offering a QHP (ii) For plan years beginning on or § 156.285 Additional standards specific to through the SHOP must use a uniform after January 1, 2020, between EHB SHOP for plan years beginning prior to January 1, 2018. enrollment form, maintain processes categories, if the State in which the plan sufficient to identify whether a group will be offered has notified HHS that * * * * * market enrollment is an enrollment (f) Applicability date. The provisions substitution between EHB categories is through the SHOP, and maintain permitted in the State. of this section apply for plan years records of SHOP enrollments for a (3) The plan that includes substituted beginning prior to January 1, 2018. period of 10 years following the benefits must: Additional standards specific to SHOP enrollment. (i) Continue to comply with the for plan years beginning on or after (g) Applicability date. The provisions requirements of paragraph (a) of this January 1, 2018 are in § 156.286. of this section apply for plan years section, including by providing benefits ■ 46. Section 156.286 is added to read beginning on or after January 1, 2018. that are substantially equal to the EHB- as follows: benchmark plan; § 156.298 [Removed] § 156.286 Additional standards specific to (ii) Provide an appropriate balance ■ 47. Section 156.298 is removed. among the EHB categories such that SHOP for plan years beginning on or after January 1, 2018. ■ 48. Section 156.340 is amended by benefits are not unduly weighted toward (a) SHOP rating and premium revising paragraph (a)(2) to read as any category; and follows: (iii) Provide benefits for diverse payment requirements. QHP issuers segments of the population. offering a QHP through a SHOP must: § 156.340 Standards for downstream and (4) The issuer submits to the State (1) Accept payment from a qualified delegated entities. evidence of actuarial equivalence that employer or an enrollee, or a SHOP on (a) * * * is: behalf of a qualified employer or (2) Exchange processes, procedures, (i) Certified by a member of the enrollee, in accordance with applicable and standards in accordance with American Academy of Actuaries; SHOP requirements. subparts H and K of part 155 and, in the (ii) Based on an analysis performed in (2) Adhere to the SHOP timeline for small group market, § 155.705 and accordance with generally accepted rate setting as established in § 155.706 of this subchapter; § 155.706(b)(6) of this subchapter; actuarial principles and methodologies; * * * * * (iii) Based on a standardized plan (3) Charge the same contract rate for ■ 49. Section 156.350 is amended by population; and a plan year; and (iv) Determined without taking cost- (4) Adhere to the premium rating revising paragraphs (a)(1) and (2) to read sharing into account. standards described in § 147.102 of this as follows: * * * * * subchapter regardless of whether the § 156.350 Eligibility and enrollment QHP being sold through the SHOP is ■ 43. Section 156.150 is amended by standards for Qualified Health Plan issuers sold in the small group market or the revising paragraph (b) to read as follows: on State-based Exchanges on the Federal large group market. platform. § 156.150 Application to stand-alone (b) Enrollment periods and processes (a) * * * dental plans inside the Exchange. for the SHOP. QHP issuers offering a (1) Section 156.285(a)(4)(ii) regarding * * * * * QHP through the SHOP must adhere to the premiums for plans offered on the (b) Calculation of AV. A stand-alone enrollment periods and processes SHOP, for plan years beginning prior to dental plan: established by the SHOP, consistent January 1, 2018; (1) May not use the AV calculator in with § 155.726 of this subchapter, and (2) Section 156.285(c)(5) and (c)(8)(iii) § 156.135; and establish a uniform enrollment timeline regarding the enrollment process for

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SHOP, for plan years beginning prior to (d) Employees hired outside of the of premium option described in January 1, 2018; and initial or annual open enrollment § 158.221(b)(8), in which case the * * * * * period. Qualified employers must allocation method description should ■ 50. Section 156.1230 is amended by provide employees hired outside of the state so), Federal and State taxes and revising paragraph (b)(2) to read as initial or annual open enrollment period licensing or regulatory fees, and other follows: with information about the enrollment non-claims costs, to each health process. insurance market in each State. A § 156.1230 Direct enrollment with the QHP (e) Participation in the SHOP and detailed description of each expense issuer in a manner considered to be termination of coverage or enrollment element must be provided, including through the Exchange. through the SHOP. (1) Changes affecting how each specific expense meets the * * * * * participation. Employers must submit a criteria for the type of expense in which (b) * * * new single employer application to the it is categorized, as well as the method (2) The QHP issuer must engage a SHOP or withdraw from participating in by which it was aggregated. third-party entity in accordance with the SHOP if the employer makes a * * * * * § 155.221 of this subchapter to change that could end its eligibility ■ 56. Section 158.221 is amended by demonstrate operational readiness and under § 155.710 of this subchapter. compliance with applicable (2) If an employer receives a adding paragraph (b)(8) to read as requirements prior to the QHP issuer’s determination of ineligibility to follows: internet website being used to complete participate in the SHOP or the SHOP § 158.221 Formula for calculating an a QHP selection. terminates its eligibility to participate in issuer’s medical loss ratio. * * * * * the SHOP, unless the SHOP notifies the * * * * * issuer or issuers of the determination of PART 157—EMPLOYER (b) * * * ineligibility or termination of eligibility, (8) Beginning with the 2017 MLR INTERACTIONS WITH EXCHANGES the employer must notify the issuer or AND SHOP PARTICIPATION reporting year, an issuer has the option issuers of QHPs in which their group of reporting an amount equal to 0.8 ■ 51. The authority citation for part 157 members are enrolled in coverage of its percent of earned premium in the continues to read as follows: ineligibility or termination of eligibility relevant State and market in lieu of within 5 business days of the end of any Authority: Title I of the Affordable Care reporting the issuer’s actual applicable appeal process under expenditures for activities that improve Act, Sections 1311, 1312, 1321, 1411, 1412, § 155.741 of this subchapter, which Pub. L. 111–148, 124 Stat. 199. health care quality, as defined in could include when the time to file an ■ 52. Section 157.205 is amended by §§ 158.150 and 158.151. If an issuer appeal lapses without an appeal being chooses this method of reporting, it revising the section heading and adding filed, when the appeal is rejected or paragraph (h) to read as follows: must apply it for a minimum of 3 dismissed, or when the appeal process consecutive MLR reporting years and for § 157.205 Qualified employer participation concludes with an adjudication by the all of its individual, small group, and process in a SHOP for plan years beginning appeals entity, as applicable. large group markets; and all affiliated prior to January 1, 2018. (3) Employers must promptly notify issuers must choose the same reporting * * * * * the issuer or issuers of QHPs in which method. (h) Applicability date. The provisions their group members are enrolled in * * * * * of this section apply for plan years coverage if it wishes to terminate beginning prior to January 1, 2018. coverage or enrollment through the ■ 57. Section 158.301 is revised to read Section 157.206 is applicable for plan SHOP, unless the SHOP notifies the as follows: years beginning on or after January 1, issuer or issuers. § 158.301 Standard for adjustment to the 2018. (f) Applicability date. The provisions medical loss ratio. ■ 53. Section 157.206 is added to read of this section apply for plan years beginning on or after January 1, 2018. The Secretary may adjust the MLR as follows: standard that must be met by issuers § 157.206 Qualified employer participation PART 158—ISSUER USE OF PREMIUM offering coverage in the individual process in a SHOP for plan years beginning REVENUE: REPORTING AND REBATE market in a State, as defined in section on or after January 1, 2018. REQUIREMENTS 2791 of the PHS Act, for a given MLR (a) General requirements. When reporting year if, in the Secretary’s joining the SHOP, a qualified employer ■ 54. The authority citation for part 158 discretion, the Secretary determines that must comply with the requirements, continues to read as follows: there is a reasonable likelihood that an processes, and timelines set forth by this Authority: Section 2718 of the Public adjustment to the 80 percent MLR part and must remain in compliance for Health Service Act (42 U.S.C. 300gg–18), as standard of section 2718(b)(1)(A)(ii) of the duration of the employer’s amended. the Public Health Service Act will help participation in the SHOP. ■ 55. Section 158.170 is amended by stabilize the individual market in that (b) Selecting QHPs. During an election revising paragraph (b) introductory text State. period, a qualified employer may make to read as follows: ■ 58. Section 158.321 is revised to read coverage in a QHP available through the as follows: SHOP in accordance with the processes § 158.170 Allocation of expenses. developed by the SHOP in accordance * * * * * § 158.321 Information regarding the with § 155.706 of this subchapter. (b) Description of the methods used to State’s individual health insurance market. (c) Information dissemination to allocate expenses. The report required (a) Subject to § 158.320, the State employees. A qualified employer in § 158.110 must include a detailed must provide, for each issuer who participating in the SHOP must description of the methods used to actively offers coverage in the disseminate information to its qualified allocate expenses, including incurred individual market in the State, the employees about the process to enroll in claims, quality improvement expenses following information, in accordance a QHP through the SHOP. (unless the report utilizes the percentage with paragraph (b) of this section, for

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the preceding calendar year and, at the standard. This proposal must include an remaining in or entering the individual State’s option, for the current year: explanation of how an adjustment to the market in the event one or more issuers (1) Total earned premium and MLR standard for the State’s individual were to cease or begin offering incurred claims; market will help stabilize the State’s individual market coverage on the (2) Total number of enrollees (life- individual market. Exchange, in certain geographic areas, years and covered lives); ■ 60. Section 158.330 is revised to read or in the entire individual market in the (3) Total agents’ and brokers’ as follows: State. commission expenses; (4) Net underwriting gain; § 158.330 Criteria for assessing request (e) Any other relevant information (5) Risk-based capital level; and for adjustment to the medical loss ratio. submitted by the State’s insurance (6) Whether the issuer has provided The Secretary may consider the commissioner, superintendent, or notice to the State’s insurance following criteria in assessing whether comparable official in the State’s commissioner, superintendent, or an adjustment to the 80 percent MLR request. comparable State authority that the standard, as calculated in accordance issuer will cease or begin offering ■ 61. Section 158.341 is revised to read with this subpart, would be reasonably as follows: individual market coverage on the likely to help stabilize the individual Exchange, certain geographic areas, or market in a State that has requested § 158.341 Treatment as a public document. the entire individual market in the such adjustment: State. (a) The number and financial A State’s request for an adjustment to (b) The information required in performance (based on data provided by the MLR standard, and all information paragraphs (a)(1) through (4) and (6) of a State under § 158.321) of issuers submitted as part of its request, will be this section must be provided separately actively offering individual health treated as a public document. for the issuer’s individual market plans insurance coverage on- and off- Instructions for how to access grouped by the following categories, as Exchange, grandfathered health plans as documents related to a State’s request applicable: On-Exchange, off-Exchange, for an adjustment to the MLR standard grandfathered health plans as defined in defined in § 147.140 of this subchapter, coverage that meets the criteria for will be made available on the § 147.140 of this subchapter, coverage Secretary’s website. that meets the criteria for transitional transitional policies outlined in policies outlined in applicable applicable guidance, and non- ■ 62. Section 158.350 is revised to read guidance, and non-grandfathered single grandfathered single risk pool coverage; as follows: risk pool coverage. The information the number of issuers reasonably likely required in paragraph (a)(5) of this to cease or begin offering individual § 158.350 Subsequent requests for adjustment to the medical loss ratio. section must be provided at the issuer market coverage in the State; and the level. likelihood that an adjustment to the 80 A State that has made a previous (c) The State must also provide percent MLR standard could help request for an adjustment to the MLR information regarding whether any increase competition in the individual standard must, in addition to the other market in the State, including in issuer other than those described in information required by this subpart, underserved areas. paragraph (a) of this section has submit information as to what steps the (b) Whether an adjustment to the 80 provided notice to the State’s insurance State has taken since its prior requests, percent MLR standard for the individual commissioner, superintendent, or if any, to improve the stability of the market may improve consumers’ access comparable State authority that the State’s individual market. issuer will cease or begin offering to agents and brokers. individual market coverage on the (c) The capacity of any new issuers or Dated: March 6, 2018. Exchange, certain geographic areas, or issuers remaining in the individual Seema Verma, the entire individual market in the market to write additional business in Administrator, Centers for Medicare & State. the event one or more issuers were to Medicaid Services. ■ 59. Section 158.322 is revised to read cease offering individual market Dated: March 28, 2018. as follows: coverage on the Exchange, in certain geographic areas, or in the entire Alex M. Azar II, § 158.322 Proposal for adjusted medical individual market in the State. Secretary, Department of Health and Human loss ratio. (d) The impact on premiums charged, Services. A State must provide its own proposal and on benefits and cost sharing [FR Doc. 2018–07355 Filed 4–9–18; 4:15 pm] as to the adjustment it seeks to the MLR provided, to consumers by issuers BILLING CODE 4120–01–P

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Part III

The President

Proclamation 9725—Pan American Day and Pan American Week, 2018

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Federal Register Presidential Documents Vol. 83, No. 74

Tuesday, April 17, 2018

Title 3— Proclamation 9725 of April 12, 2018

The President Pan American Day and Pan American Week, 2018

By the President of the United States of America

A Proclamation On Pan American Day and during Pan American Week, we commemorate the 128th anniversary of the First International Conference of American States, which concluded on April 14, 1890, and paved the way for the establishment of the Organization of American States in 1948. As the Organi- zation of American States celebrates the 70th anniversary of its founding this year, the United States reaffirms our commitment to partner with the nations of the Americas to advance security, economic and energy prosperity, and democratic governance throughout the hemisphere. This week, Vice President Pence will join with leaders in the Pan American region to address corruption and develop strategies to defeat transnational criminal organizations in our hemisphere. During the eighth Summit of the Americas, the United States will look to strengthen the region’s collective commitment to representative democracy, to government accountability, and to confront threats to freedom. Tragically, the core tenets of free society have been abandoned in Venezuela and Cuba. Our hemispheric community of democracies must support the Venezuelan people and their right to have a voice in their government through free, fair, and internationally validated elections. Furthermore, the United States will not cease in its efforts to secure a future of freedom, peace, and prosperity for the people of Cuba. Under my Administration, the United States will continue to be a steady, enduring partner to Latin American and Caribbean countries. The United States will continue bilateral discussions on efforts to disrupt the organized crime organizations and trafficking routes that harm our citizens and drive irregular migration. My Administration supports ongoing regional security coordination through programs such as the Merida Initiative in Mexico, the Central American Regional Security Initiative, and the Caribbean Basin Security Initiative, as well as regular meetings, including our Strategic Dia- logue to Disrupt Transnational Criminal Organizations with Mexico. At the heart of our engagement is the belief that by working together we can achieve a more prosperous and secure future for our region. As we observe Pan American Day and Pan American Week, let us capitalize on this momentum and build on our common history with a mutual purpose to achieve hemispheric peace and prosperity. NOW, THEREFORE, I, DONALD J. TRUMP, President of the United States of America, by virtue of the authority vested in me by the Constitution and the laws of the United States, do hereby proclaim April 14, 2018, as Pan American Day and April 8 through April 14, 2018, as Pan American Week. I urge the Governors of the 50 States, the Governor of the Common- wealth of Puerto Rico, and the officials of the other areas under the flag of the United States of America to honor these observances with appropriate ceremonies and activities.

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IN WITNESS WHEREOF, I have hereunto set my hand this twelfth day of April, in the year of our Lord two thousand eighteen, and of the Independ- ence of the United States of America the two hundred and forty-second.

[FR Doc. 2018–08172 4–16–18; 11:15 am] Billing code 3295–F8–P

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Reader Aids Federal Register Vol. 83, No. 74 Tuesday, April 17, 2018

CUSTOMER SERVICE AND INFORMATION CFR PARTS AFFECTED DURING APRIL

Federal Register/Code of Federal Regulations At the end of each month the Office of the Federal Register General Information, indexes and other finding 202–741–6000 publishes separately a List of CFR Sections Affected (LSA), which aids lists parts and sections affected –by documents published since Laws 741–6000 the revision date of each title. 956...... 14736 Presidential Documents 3 CFR 958...... 14736 Executive orders and proclamations 741–6000 Proclamations: 966...... 14357 The United States Government Manual 741–6000 9713...... 14341 981...... 14738 9714...... 14343 Other Services 984...... 14738 9715...... 14345 987...... 14738 Electronic and on-line services (voice) 741–6020 9716...... 14559 993...... 14738 741–6050 Privacy Act Compilation 9717...... 14561 Proposed Rules: Public Laws Update Service (numbers, dates, etc.) 741–6043 9718...... 14563 205...... 16010 9719...... 14727 905...... 14203 9720...... 15017 ELECTRONIC RESEARCH 932...... 14379 9721...... 15727 985...... 14766 World Wide Web 9722...... 15729 1051...... 14110 9723...... 15937 1206...... 14771 Full text of the daily Federal Register, CFR and other publications 9724...... 16183 is located at: www.fdsys.gov. 9725...... 17075 8 CFR Federal Register information and research tools, including Public Executive Orders: 270...... 13826 Inspection List, indexes, and Code of Federal Regulations are 13828...... 15941 274a...... 13826 located at: www.ofr.gov. Administrative Orders: 280...... 13826 Memorandums: 9 CFR E-mail Memorandum of April 53...... 15491 FEDREGTOC (Daily Federal Register Table of Contents Electronic 4, 2018 ...... 15289 71...... 15491 Mailing List) is an open e-mail service that provides subscribers Memorandum of April 91...... 15491 with a digital form of the Federal Register Table of Contents. The 6, 2018 ...... 16179 93...... 15491 digital form of the Federal Register Table of Contents includes Memorandum of April 94...... 15491 HTML and PDF links to the full text of each document. 12, 2018 ...... 16761 Notices: 95...... 15491 To join or leave, go to https://public.govdelivery.com/accounts/ Notice of April 4, 98...... 15491 USGPOOFR/subscriber/new, enter your email address, then 2018 ...... 14731 104...... 15491 follow the instructions to join, leave, or manage your Proposed Rules: subscription. 4 CFR 93...... 15756 PENS (Public Law Electronic Notification Service) is an e-mail 21...... 13817 145...... 15082 service that notifies subscribers of recently enacted laws. 146...... 15082 5 CFR 147...... 15082 To subscribe, go to http://listserv.gsa.gov/archives/publaws-l.html 630...... 15291 and select Join or leave the list (or change settings); then follow 10 CFR the instructions. 6 CFR Proposed Rules: FEDREGTOC and PENS are mailing lists only. We cannot 27...... 13826 431...... 15514 respond to specific inquiries. 7 CFR 12 CFR Reference questions. Send questions and comments about the Federal Register system to: [email protected] 205...... 14347 25...... 15298 215...... 14173 34...... 15019 The Federal Register staff cannot interpret specific documents or 227...... 14173 195...... 15298 regulations. 246...... 14173 225...... 15019 CFR Checklist. Effective January 1, 2009, the CFR Checklist no 247...... 14173 228...... 15298 longer appears in the Federal Register. This information can be 248...... 14173 323...... 15019 found online at http://bookstore.gpo.gov/. 249...... 14173 326...... 13839 272...... 14173 327...... 14565 FEDERAL REGISTER PAGES AND DATE, APRIL 277...... 14173 343...... 13843 319...... 14733 345...... 15298 13817–14172...... 2 457...... 16767 390...... 13843 14173–14346...... 3 900...... 14736 391...... 13839 14347–14564...... 4 905...... 14348 741...... 14741 14565–14732...... 5 915...... 14736 Proposed Rules: 14733–15018...... 6 917...... 14736 303...... 15327 923...... 14736 325...... 13880 15019–15290...... 9 925...... 14736 333...... 15327 15291–15490...... 10 929...... 14350 390...... 15327 15491–15726...... 11 932...... 14736 900...... 14205 15727–15936...... 12 946...... 14736 906...... 14205 15937–16182...... 13 948...... 14736 956...... 14205 16183–16766...... 16 953...... 14736 957...... 14205 16767–17076...... 17 955...... 14736 958...... 14205

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959...... 14205 Proposed Rules: 15316, 15743, 16774, 16775, 156...... 16930 960...... 14205 312...... 14611 16776 157...... 16930 961...... 14205 165 ...... 14367, 14589, 14752, 158...... 16930 962...... 14205 19 CFR 15499, 15948, 15950, 15952, 1603...... 16785 963...... 14205 4...... 13826 16778, 16780 964...... 14205 101...... 15498 334...... 16783 47 CFR 965...... 14205 149...... 15736 Proposed Rules: 2...... 15754 966...... 14205 100 ...... 14219, 14381, 15096, 51...... 14185 967...... 14205 20 CFR 15099, 16808 54 ...... 14185, 15502, 15982 968...... 14205 404...... 13862 165 ...... 14226, 14384, 14801, 69...... 14185 969...... 14205 16265, 16267, 16811, 16815, Proposed Rules: 970...... 14205 21 CFR 16817 1 ...... 13888, 14395, 15531 971...... 14205 510...... 14584 2...... 13888 972...... 14205 520...... 14584 37 CFR 5...... 13888 973...... 14205 522...... 14584 401...... 15954 15...... 13888 974...... 14205 526...... 14584 404...... 15954 73...... 13903, 15531 975...... 14205 558...... 14584 Proposed Rules: 101...... 13888 976...... 14205 890...... 13863 977...... 14205 202...... 16269 48 CFR 900...... 13863 978...... 14205 1020...... 13863 38 CFR 202...... 15994 979...... 14205 1040...... 13863 4...... 15068, 15316 207...... 15995 980...... 14205 210...... 15995 Proposed Rules: Proposed Rules: 981...... 14205 211...... 15996 73...... 15089 1...... 14613 982...... 14205 212...... 16001 3...... 14803 983...... 14205 22 CFR 213...... 16001 5...... 14803 984...... 14205 215...... 15996 193...... 15740 17...... 14804 985...... 14205 219 ...... 15995, 15996, 16001 986...... 14205 225...... 16003 987...... 14205 23 CFR 39 CFR 237...... 16001, 16004 988...... 14205 Proposed Rules: 111...... 14369 239...... 15994 989...... 14205 658...... 15524 242...... 15996 990...... 14205 790...... 16262 40 CFR 252...... 15996, 16001 991...... 14205 52 ...... 13867, 13869, 13871, 992...... 14205 25 CFR 801...... 16206 13872, 13875, 14175, 14179, 802...... 16206 993...... 14205 Proposed Rules: 14373, 14591, 14754, 14757, 803...... 16206 994...... 14205 30...... 16806 14759, 14762, 15074, 15744, 812...... 16206 995...... 14205 15746, 16200 996...... 14205 26 CFR 814...... 16206 60...... 15964 822...... 16206 997...... 14205 1...... 14175 61...... 15964 852...... 16206 998...... 14205 62...... 13878 Proposed Rules: 999...... 14205 27 CFR 63...... 15964 831...... 14826 Ch. XII...... 14605 9...... 14745 70...... 14762 833...... 14826 1239...... 14781 81...... 14373, 14597 Proposed Rules: 844...... 14833 1273...... 14781 180 ...... 15748, 15971, 15977, 9 ...... 14787, 14791, 14795, 845...... 14833 16200 14 CFR 15091 852...... 14826 770...... 14375 25 ...... 14360, 15301, 15304 871...... 14826 28 CFR Proposed Rules: 27...... 15945 1009...... 15502 52 ...... 14386, 14389, 14807, 39 ...... 14568, 14741, 14743, 16...... 14749 1052...... 15502 15336, 15343, 15526, 16017, 15036, 15038, 15041, 15043, 2402...... 15101 29 CFR 16021, 16276, 16279 15045, 15048, 15310, 15313, 2416...... 15101 60...... 15458, 16027 15495, 15731, 15733, 16185, 1926...... 15499 2437...... 15101 61...... 16027 16188, 16191, 16194, 16768 4022...... 15946 2442...... 15101 62...... 14232 71 ...... 14574, 14576, 14580, 2452...... 15101 30 CFR 63 ...... 14984, 15458, 16027 14745, 15050 81...... 16021 49 CFR 73...... 14174 56...... 15055 97...... 15051, 15052 57...... 15055 180...... 15528 370...... 16210 371...... 16210 Proposed Rules: 31 CFR 42 CFR 39 ...... 13883, 13885, 14207, 373...... 16210 405...... 16440 14606, 15517, 15519, 16010, Proposed Rules: 375...... 16210 417...... 16440 16013, 16015, 16243, 16245, 30...... 15095 376...... 16210 422...... 16440 16248, 16251, 16787, 16792, 32...... 15095 378...... 16210 423...... 16440 16794, 16796, 16799 379...... 16210 32 CFR 460...... 16440 71 ...... 14608, 14610, 14785, 380...... 16210 498...... 16440 15521, 16256, 16258, 16259, 81...... 15065 382...... 16210 16261, 16802, 16804 182...... 14588 Proposed Rules: 387...... 16210 135...... 15332 185...... 14589 100...... 14391 390...... 16210 215...... 16774 391...... 16210 15 CFR 706...... 16198 44 CFR 395...... 16210 738...... 13849 734...... 16199 64...... 14376 396...... 16210 740...... 13849 398...... 16210 745...... 13849 33 CFR 45 CFR 1001...... 15075, 16786 774...... 13849, 14580 27...... 13826 5b...... 14183 1003...... 15075, 16786 2008...... 15054 100 ...... 14364, 14751, 15065, 147...... 16930 1004...... 15075, 16786 15741 153...... 16930 1005...... 15075, 16786 16 CFR 117 ...... 13865, 13866, 13867, 154...... 16930 1007...... 15075, 16786 305...... 14583 14365, 14367, 15067, 15315, 155...... 16930 1011...... 15075, 16786

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1012...... 15075, 16786 1114...... 15075, 16786 1200...... 15075, 16786 578...... 13904 1013...... 15075, 16786 1116...... 15075, 16786 1220...... 15075, 16786 1016...... 15075, 16786 1117...... 15075, 16786 1242...... 15075, 16786 50 CFR 1018...... 15075, 16786 1119...... 15075, 16786 1243...... 15075, 16786 17 ...... 14189, 14198, 14958, 1019...... 15075, 16786 1120...... 15075, 16786 1244...... 15075, 16786 16228 1033...... 15075, 16786 1132...... 15075, 16786 1245...... 15075, 16786 23...... 15503 1034...... 15075, 16786 1133...... 15075, 16786 1246...... 15075, 16786 300...... 15503 1035...... 15075, 16786 1135...... 15075, 16786 1247...... 15075, 16786 622...... 14202 1037...... 15075, 16786 1141...... 15075, 16786 1248...... 15075, 16786 648 ...... 15240, 15511, 15754 1090...... 15075, 16786 1144...... 15075, 16786 1253...... 15075, 16786 660...... 16005 1100...... 15075, 16786 1146...... 15075, 16786 1305...... 15075, 16786 679 ...... 14603, 15324, 15325, 1101...... 15075, 16786 1147...... 15075, 16786 1310...... 15075, 16786 15755, 16008 1103...... 15075, 16786 1150...... 15075, 16786 1312...... 15075, 16786 Proposed Rules: 1104...... 15075, 16786 1152...... 15075, 16786 1313...... 15075, 16786 17 ...... 13919, 14836, 15758, 1105...... 15075, 16786 1155...... 15075, 16786 1319...... 15075, 16786 15900, 16819 1106...... 15075, 16786 1177...... 15075, 16786 1331...... 15075, 16786 217...... 16027 1108...... 15075, 16786 1180...... 15075, 16786 1333...... 15075, 16786 218...... 15117 1110...... 15075, 16786 1182...... 15075, 16786 1503...... 13826 622 ...... 14234, 14400, 16282 1112...... 15075, 16786 1184...... 15075, 16786 Proposed Rules: 648 ...... 14236, 15535, 15780 1113...... 15075, 16786 1185...... 15075, 16786 571...... 16280 679...... 15538

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in ‘‘slip law’’ (individual Act of 2018 (Apr. 13, 2018; enacted public laws. To pamphlet) form from the 132 Stat. 1257) subscribe, go to http:// LIST OF PUBLIC LAWS Superintendent of Documents, S. 772/P.L. 115–166 listserv.gsa.gov/archives/ U.S. Government Publishing Ashlynne Mike AMBER Alert publaws-l.html This is a continuing list of Office, Washington, DC 20402 in Indian Country Act (Apr. 13, public bills from the current (phone, 202–512–1808). The 2018; 132 Stat. 1274) Note: This service is strictly session of Congress which text will also be made Last List April 13, 2018 have become Federal laws. available on the Internet from for E-mail notification of new This list is also available GPO’s Federal Digital System laws. The text of laws is not online at http:// (FDsys) at http://www.gpo.gov/ Public Laws Electronic available through this service. www.archives.gov/federal- fdsys. Some laws may not yet Notification Service PENS cannot respond to register/laws. be available. (PENS) specific inquiries sent to this address. The text of laws is not H.R. 4547/P.L. 115–165 published in the Federal Strengthening Protections for PENS is a free electronic mail Register but may be ordered Social Security Beneficiaries notification service of newly

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