Vol. 83 Thursday, No. 183 September 20, 2018

Pages 47547–47800

OFFICE OF THE FEDERAL REGISTER

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Contents Federal Register Vol. 83, No. 183

Thursday, September 20, 2018

Agency for Healthcare Research and Quality Commerce Department NOTICES See National Oceanic and Atmospheric Administration Requests for Supplemental Evidence and Data Submissions: Depression in Children: Systematic Review, 47616–47619 Commodity Futures Trading Commission NOTICES Agriculture Department Agency Information Collection Activities; Proposals, See Animal and Plant Health Inspection Service Submissions, and Approvals, 47608–47609 See The U.S. Codex Office Meetings: NOTICES Technology Advisory Committee, 47608 Meetings: Meetings; Sunshine Act, 47608 National Agricultural Research, Extension, Education, and Economics Advisory Board, 47600 Consumer Product Safety Commission NOTICES Animal and Plant Health Inspection Service Meetings; Sunshine Act, 47609 NOTICES Agency Information Collection Activities; Proposals, Defense Department Submissions, and Approvals: See Army Department Importation of Fresh Peppers From Peru Into Continental See Navy Department United States and Territories, 47600–47601 NOTICES Agency Information Collection Activities; Proposals, Antitrust Division Submissions, and Approvals, 47610–47611 Arms Sales, 47611–47613 NOTICES Changes Under the National Cooperative Research and Education Department Production Act: NOTICES Advanced Media Workflow Assn., Inc., 47642–47643 Agency Information Collection Activities; Proposals, PXI Systems Alliance, Inc., 47643 Submissions, and Approvals: Borrower Defenses Against Loan Repayment, 47614– Army Department 47615 NOTICES Agency Information Collection Activities; Proposals, Employment and Training Administration Submissions, and Approvals, 47609–47610 NOTICES Agency Information Collection Activities; Proposals, Centers for Disease Control and Prevention Submissions, and Approvals: NOTICES Data Collections From Industry-Recognized Performance Review Board Membership, 47619 Apprenticeship Program Accreditors, 47643–47644

Centers for Medicare & Medicaid Services Energy Department PROPOSED RULES See Federal Energy Regulatory Commission Medicare and Medicaid Programs: Regulatory Provisions To Promote Program Efficiency, Environmental Protection Agency Transparency, and Burden Reduction, 47686–47762 RULES NOTICES Air Quality State Implementation Plans; Approvals and Medicare Program: Promulgations: Medicare Appeals; Adjustment to Amount in Controversy Arkansas; Interstate Transport Requirements for 2012 Threshold Amounts for Calendar Year 2019, 47619– PM2.5 NAAQS and Definition Update, 47569–47571 47620 Missouri; Redesignation of Missouri Portion of St. Louis- Privacy Act; Matching Programs, 47620–47622 St. Charles-Farmington, MO-IL 2008 Ozone Area to Attainment, 47572–47574 Civil Rights Commission Utah; Infrastructure Monitoring Requirements for 2008 NOTICES Lead, 2010 Sulfur Dioxide, 2010 Nitrogen Dioxide Meetings: and 2012 Fine Particulate Matter National Ambient Colorado Advisory Committee, 47604 Air Quality Standards, 47566–47568 Washington; Interstate Transport Requirements for 2015 Coast Guard Ozone NAAQS, 47568–47569 RULES Wyoming; Incorporation by Reference Updates, 47564– Drawbridge Operations: 47566 Atlantic Intracoastal Waterway, Palm Beach, FL, 47560– 47562 Federal Aviation Administration Safety Zones: RULES C and S Worldwide Holdings, Inc., Fireworks, Lake Transport Airplane Fuel Tank and System Lightning Ontario, Oswego, NY, 47562–47564 Protection, 47548–47557

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PROPOSED RULES See Food and Drug Administration Amendment of Class D Airspace: See Health Resources and Services Administration Detroit, MI, 47580–47581 See National Institutes of Health Pontiac, MI, 47578–47580 Amendment of Class D and E Airspace and Revocation of Health Resources and Services Administration Class E Airspace: NOTICES Fayetteville, AR, 47585–47587 Meetings: Amendment of Class E Airspace: Advisory Committee on Heritable Disorders in Newborns Cabool, MO, 47583–47585 and Children, 47628–47629 Amendment of Class E Airspace; and Establishment of Class E Airspace: Homeland Security Department Mountain City, TN; and Elizabethton, TN, 47577–47578 See Coast Guard Establishment of Class E Airspace, and Amendment of See Transportation Security Administration Class D Airspace and Class E Airspace: Dothan, AL, 47581–47583 Housing and Urban Development Department Federal Election Commission NOTICES NOTICES Environmental Impact Statements; Availability, etc.: Meetings; Sunshine Act, 47616 Rose Hill Courts Redevelopment, 47638–47639

Federal Energy Regulatory Commission Interior Department NOTICES See Land Management Bureau Meetings; Sunshine Act, 47615–47616 See National Park Service

Federal Highway Administration International Trade Commission NOTICES NOTICES Experimental Project To Evaluate Proposals for Delegation Complaints: of Certain Program-Wide FHWA Responsibilities to Certain LTE- and 3G- Compliant Cellular States, 47674–47676 Communications Devices, 47641–47642 Investigations; Determinations, Modifications, and Rulings, Federal Motor Carrier Safety Administration etc.: PROPOSED RULES Certain Network Devices, Related Software and Hours of Service, 47589–47591 Components Thereof, 47641 Hours of Service of Drivers, 47591–47592 Forged Steel Fittings From Taiwan, 47640–47641 Lease and Interchange of Vehicles: Motor Carriers of Passengers, 47764–47788 Justice Department See Antitrust Division Federal Retirement Thrift Investment Board RULES Labor Department Tax Withholding on Court Ordered Payments, 47547–47548 See Employment and Training Administration NOTICES Federal Transit Administration 2018 Update to Department of Labor’s List of Goods RULES Produced by Child Labor or Forced Labor, 47644– Capital Leases, 47574–47576 47645 Food and Drug Administration Land Management Bureau RULES Food Additives Permitted for Direct Addition to Food for NOTICES Human Consumption: Oil and Gas Leases: Vitamin D3, 47557–47560 Ohio; Proposed Reinstatement, 47639–47640 NOTICES Wyoming (Southland 17); Proposed Reinstatement, 47640 Guidance: Grandfathering Policy for Packages and Homogenous Maritime Administration Cases of Product Without a Product Identifier, NOTICES 47622–47623 Requests for Administrative Waivers of the Coastwise Trade Heparin-Containing Medical Devices and Combination Laws: Products: Recommendations for Labeling and Safety Vessel FIRST WAVE, 47680 Testing, 47623–47625 Vessel GIOVANNINO, 47679–47680 Product Identifier Requirements Under the Drug Supply Vessel MISS BROOKE, 47681–47682 Chain Security Act—Compliance Policy, 47625– Vessel OCEAN SPIRIT, 47681 47626 Vessel ONE IRON, 47677–47678 Product Identifiers Under the Drug Supply Chain Vessel REBEL SOUL, 47676–47677 Security Act Questions and Answers, 47626–47628 Vessel RICHARD H. DANA, 47678–47679

Health and Human Services Department National Aeronautics and Space Administration See Agency for Healthcare Research and Quality NOTICES See Centers for Disease Control and Prevention Meetings: See Centers for Medicare & Medicaid Services Astrophysics Advisory Committee, 47645

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National Institutes of Health Nuclear Regulatory Commission NOTICES NOTICES Government-Owned Inventions; Availability for Licensing, Guidance: 47629–47630 Protection Against Malevolent Use of Vehicles at Nuclear Meetings: Power Plants; Withdrawal, 47648 Center for Scientific Review, 47630–47633, 47635–47637 License Renewals: Center for Scientific Review; Amendment, 47630 Entergy Nuclear Operations, Inc., Indian Point Nuclear National Advisory Council for Complementary and Generating Unit Nos. 2 and 3, 47648–47650 Integrative Health, 47637 Proposed Revisions to Branch Technical Position 5–3 National Cancer Institute, 47629, 47635 Fracture Toughness Requirements, 47647–47648 National Institute of Allergy and Infectious Diseases, Postal Regulatory Commission 47630, 47633 NOTICES National Institute of Dental and Craniofacial Research, New Postal Products, 47650–47651 47630 National Institute of General Medical Sciences, 47632 Postal Service National Institute on Aging, 47634 NOTICES National Institute on Drug Abuse, 47633–47634 Meetings; Sunshine Act, 47651 Policy Manual: Product Changes: Preventing and Addressing Harassment and Inappropriate Parcel Select Negotiated Service Agreement, 47651 Conduct and New Policy Statement on Inappropriate Relationships in the Workplace, 47634–47635 Presidential Documents ADMINISTRATIVE ORDERS International Postal System, Monetary Reimbursement National Oceanic and Atmospheric Administration Model for Delivery of Goods and Security Protocols; PROPOSED RULES Modernization Efforts (Memorandum of August 23, Atlantic Highly Migratory Species: 2018), 47789–47794 Shortfin Mako Shark Management Measures; Proposed Reinforcing Education Accountability in Development Act; Amendment 11, 47598–47599 Delegation of Authorities (Memorandum of August 31, Endangered and Threatened Species: 2018), 47795 Positive 90-Day Finding on Petition To List Cauliflower Terrorist Attacks; Continuation of National Emergency With Coral, Pocillopora Meandrina, in Hawaii, 47592– Respect to Persons, 47797–47799 47598 NOTICES Presidio Trust Applications: NOTICES Marine Mammals; File No. 21425, 47606 Meetings: Meetings: Board of Directors, 47651 Columbia Basin Partnership Task Force of Marine Fisheries Advisory Committee, 47607 Securities and Exchange Commission Gulf of Mexico Fishery Management Council, 47605– NOTICES 47606 Applications: New England Fishery Management Council, 47605 Exact Sciences Corp., 47657–47659 Pacific Fishery Management Council, 47605 Self-Regulatory Organizations; Proposed Rule Changes: Permits: Cboe BZX Exchange, Inc., 47659–47662 Marine Mammals and Endangered Species, 47606–47607 Cboe C2 Exchange, Inc., 47651–47654 Cboe EDGA Exchange, Inc., 47654–47657 Cboe Exchange, Inc., 47663–47665 National Park Service Financial Industry Regulatory Authority, Inc., 47666– PROPOSED RULES 47673 Special Regulations, Areas of the National Park System: ICE Clear Credit, LLC, 47665–47666 Death Valley National Park; Designation of Airstrip, NYSE Arca, Inc., 47654 47587–47589 Small Business Administration NOTICES National Science Foundation Disaster Declarations: NOTICES Alaska; Public Assistance Only, 47673 Antarctic Conservation Act Permits, 47645–47646 Minnesota; Public Assistance Only, 47673–47674 Meetings: Meetings: Advisory Committee for Education and Human Audit and Financial Management Advisory Committee, Resources, 47646–47647 47673–47674 Proposal Review Panel for International Science and Engineering, 47646 The U.S. Codex Office NOTICES Meetings: Navy Department Codex Alimentarius Commission: Codex Committee on NOTICES Food Hygiene, 47603–47604 Agency Information Collection Activities; Proposals, Codex Alimentarius Commission: Codex Committee on Submissions, and Approvals, 47613–47614 Nutrition and Foods for Special Dietary Uses, 47601– Privacy Act; Systems of Records; Correction, 47614 47603

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Transportation Department Part III See Federal Aviation Administration Transportation Department, Federal Motor Carrier Safety See Federal Highway Administration Administration, 47764–47788 See Federal Motor Carrier Safety Administration See Federal Transit Administration See Maritime Administration Part IV Presidential Documents, 47789–47794 Transportation Security Administration NOTICES Agency Information Collection Activities; Proposals, Part V Submissions, and Approvals: Presidential Documents, 47797–47799 TSA Claims Application, 47637–47638 Veterans Affairs Department NOTICES Reader Aids Meetings: Consult the Reader Aids section at the end of this issue for Advisory Committee on Prosthetics and Special- phone numbers, online resources, finding aids, and notice Disabilities Programs, 47682–47683 of recently enacted public laws. To subscribe to the Federal Register Table of Contents Separate Parts In This Issue electronic mailing list, go to https://public.govdelivery.com/ accounts/USGPOOFR/subscriber/new, enter your e-mail Part II address, then follow the instructions to join, leave, or Health and Human Services Department, Centers for manage your subscription. Medicare & Medicaid Services, 47686–47762

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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 Adminstrative Orders: Memorandums: Memorandum of August 23, 2018...... 47791 Memorandum of August 31, 2018...... 47795 Notices: Notice of September 19, 2018 ...... 47799 5 CFR 1653...... 47547 14 CFR 25...... 47548 Proposed Rules: 71 (6 documents) ...... 47577, 47578, 47580, 47581, 47583, 47585 21 CFR 172...... 47557 33 CFR 117...... 47560 165...... 47562 36 CFR Proposed Rules: 7...... 47587 40 CFR 52 (5 documents) ...... 47564, 47566, 47568, 47569, 47572 81...... 47572 42 CFR Proposed Rules: 403...... 47686 416...... 47686 418...... 47686 441...... 47686 460...... 47686 482...... 47686 483...... 47686 484...... 47686 485...... 47686 486...... 47686 488...... 47686 491...... 47686 494...... 47686 49 CFR 639...... 47574 Proposed Rules: 390...... 47764 395 (2 documents) ...... 47589, 47591 50 CFR Proposed Rules: 223...... 47592 224...... 47592 635...... 47598

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Rules and Regulations Federal Register Vol. 83, No. 183

Thursday, September 20, 2018

This section of the FEDERAL REGISTER System Act of 1986 (FERSA), Public savings plan created under the Federal contains regulatory documents having general Law 99–335, 100 Stat. 514. The TSP Employees’ Retirement System Act of applicability and legal effect, most of which provisions of FERSA are codified, as 1986 (FERSA), Public Law 99–335, 100 are keyed to and codified in the Code of amended, largely at 5 U.S.C. 8351 and Stat. 514, and which is administered by Federal Regulations, which is published under 8401–79. The TSP is a tax-deferred the FRTIB. 50 titles pursuant to 44 U.S.C. 1510. retirement savings plan for Federal Paperwork Reduction Act The Code of Federal Regulations is sold by civilian employees and members of the the Superintendent of Documents. uniformed services. The TSP is similar I certify that these regulations do not to cash or deferred arrangements require additional reporting under the established for private-sector employees criteria of the Paperwork Reduction Act. FEDERAL RETIREMENT THRIFT under section 401(k) of the Internal INVESTMENT BOARD Unfunded Mandates Reform Act of Revenue Code (26 U.S.C. 401(k)). 1995 Currently, paragraph (e) of 5 CFR 5 CFR Part 1653 1635.5 specifies the person to whom a Pursuant to the Unfunded Mandates court ordered payment from the TSP Reform Act of 1995, 2 U.S.C. 602, 632, Tax Withholding on Court Ordered may be made and, in addition, specifies 653, 1501–1571, the effects of this Payments the Federal income tax withholding regulation on state, local, and tribal AGENCY: Federal Retirement Thrift rates on such payments. This rule governments and the private sector have Investment Board. deletes the language that specifies the been assessed. This regulation will not ACTION: Direct final rule. Federal income tax withholding rates on compel the expenditure in any one year court ordered TSP payments. of $100 million or more by state, local, SUMMARY: This rule deletes regulatory The Federal income tax withholding and tribal governments, in the aggregate, language that provides for the Federal rates on all TSP payments are dictated or by the private sector. Therefore, a income tax withholding rates on court by the Internal Revenue Code. As such, statement under section 1532 is not ordered payments from the Thrift any FRTIB regulatory language that required. Savings Plan. expresses the withholding rates are, at best, duplicative of the Internal Revenue Submission to Congress and the DATES: This rule is effective without General Accounting Office further action on October 22, 2018, Code. The Federal income tax unless significant adverse comment is withholding rates required by the Pursuant to 5 U.S.C. 810(a)(1)(A), the received by October 15, 2018. If Internal Revenue Code are more Agency submitted a report containing significant adverse comment is received, appropriately communicated to this rule and other required information the FRTIB will publish a timely participants and beneficiaries via the to the U.S. Senate, the U.S. House of withdrawal of the rule in the Federal TSP website or via forms and Representatives, and the Comptroller Register. publications provided directly to them. General of the United States before publication of this rule in the Federal Type of Rulemaking ADDRESSES: You may submit comments Register. This rule is not a major rule as using one of the following methods: In a direct final rulemaking, an agency • defined at 5 U.S.C. 814(2). Federal Rulemaking Portal: http:// publishes a direct final rule in the www.regulations.gov. Follow the Federal Register along with a statement List of Subjects in 5 CFR Part 1653 instructions for submitting comments. • that the rule will become effective Alimony, Child support, Government Mail: Office of General Counsel, unless the agency receives significant employees, Pensions, Retirement. Attn: Megan G. Grumbine, Federal adverse comment within a specified Retirement Thrift Investment Board, 77 period. The FRTIB is using a direct final Ravindra Deo, K Street NE, Suite 1000, Washington, rule for this rulemaking because it Executive Director, Federal Retirement Thrift DC 20002. Investment Board. • expects this regulation to be Hand Delivery/Courier: The address noncontroversial. The FRTIB will For the reasons stated in the for sending comments by hand delivery withdraw the rule if it receives preamble, the Agency amends 5 CFR or courier is the same as that for significant adverse comment. Comments chapter VI as follows: submitting comments by mail. • that are not adverse may be considered Facsimile: Comments may be for modifications to part 1653 at a future PART 1653—COURT ORDERS AND submitted by facsimile at (202) 942– date. If no significant adverse comment LEGAL PROCESSES AFFECTING 1676. is received, the rule will become THRIFT SAVINGS PLAN ACCOUNTS The most helpful comments explain effective without additional action. the reason for any recommended change ■ 1. The authority citation for part 1653 and include data, information, and the Regulatory Flexibility Act continues to read as follows: authority that supports the I certify that this regulation will not Authority: 5 U.S.C. 8432d, 8435, 8436(b), recommended change. have a significant economic impact on 8437(e), 8439(a)(3), 8467, 8474(b)(5) and FOR FURTHER INFORMATION CONTACT: a substantial number of small entities. 8474(c)(1). Laurissa Stokes at (202) 942–1645. This regulation will affect Federal ■ 2. Amend § 1653.5 by revising SUPPLEMENTARY INFORMATION: The employees and members of the paragraph (e) to read as follows: FRTIB administers the Thrift Savings uniformed services who participate in Plan (TSP), which was established by the Thrift Savings Plan, which is a § 1653.5 Payment. the Federal Employees’ Retirement Federal defined contribution retirement * * * * *

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(e) Payment will be made only to the FOR FURTHER INFORMATION CONTACT: For effects to be extremely improbable; and person or persons specified in the court questions concerning this action, requires applicants to add airworthiness order. However, if the court order contact Stephen Slotte, Airplane and limitations to the airplane’s Instructions specifies a third-party mailing address Flight Crew Interface Section, AIR–671, for Continued Airworthiness (ICA) to for the payment, the TSP will mail to Transport Standards Branch, Policy and prevent catastrophic fuel vapor ignition the address specified any portion of the Innovation Division, Aircraft caused by lightning. These changes payment that is not transferred to a Certification Service, Federal Aviation align the rule with the current traditional IRA, Roth IRA, or eligible Administration, 2200 South 216th understanding of lightning-related risk, employer plan. Street, Des Moines, WA 98198; fuel tank flammability exposure, and * * * * * telephone and fax (206) 231–3163; email current airplane design practices. It also [FR Doc. 2018–20471 Filed 9–19–18; 8:45 am] [email protected]. revises the title of § 25.981 to ‘‘Fuel tank BILLING CODE 6760–01–P SUPPLEMENTARY INFORMATION: explosion prevention.’’ This amendment removes lightning Authority for This Rulemaking from the ignition sources regulated by § 25.981(a)(3). Inclusion of lightning in DEPARTMENT OF TRANSPORTATION The FAA’s authority to issue rules on aviation safety is found in Title 49 of the that section has resulted in applicants Federal Aviation Administration United States Code. Subtitle I, Section showing that compliance was 106 describes the authority of the FAA impractical, leading them to seek 14 CFR Part 25 Administrator. Subtitle VII, Aviation exemptions to compliance with § 25.981 Programs, describes in more detail the for fuel tank structure and systems. The [Docket No.: FAA–2014–1027; Amdt. No. scope of the agency’s authority. FAA has granted several exemptions for 25–146] This rulemaking is promulgated fuel tank structure and systems. The RIN 2120–AK24 under the authority described in FAA agrees, however, with the Large Subtitle VII, Part A, Subpart III, Section Airplane Fuel System Lightning Transport Airplane Fuel Tank and 44701, ‘‘General Requirements.’’ Under Protection Aviation Rulemaking System Lightning Protection that section, the FAA is charged with Committee (Lightning ARC) 4 that common regulatory treatment of AGENCY: Federal Aviation promoting safe flight of civil aircraft in structure- and systems-related lightning Administration (FAA), DOT. air commerce by prescribing regulations and minimum standards for the design protection in the fuel system is ACTION: Final rule. and performance of aircraft that the appropriate. Applicants have also SUMMARY: The FAA is amending certain Administrator finds necessary for safety requested that the FAA develop special airworthiness regulations for transport in air commerce. This regulation is conditions to allow the consideration of category airplanes regarding lightning within the scope of that authority. It fuel tank flammability and the protection of fuel systems. This action is prescribes revised safety standards for probability of lightning strikes when relieving in several ways. It removes the the design and operation of transport meeting the requirement that a fuel tank requirement for manufacturers to category airplanes. explosion caused by lightning be extremely improbable. This amendment provide triple-redundant fault tolerance I. Overview of Final Rule in lightning protection. It removes removes the necessity for such special regulatory inconsistency by establishing The FAA is amending the conditions by incorporating such a single standard for lightning airworthiness regulations in title 14, considerations into the rule. To maintain the integrity of lightning protection of both fuel tank structure Code of Federal Regulations (14 CFR) protection features of airplanes, this and fuel tank systems. It establishes a part 25 related to the lightning 1 amendment adds a new paragraph (d) to performance-based standard that the protection of fuel systems (including 2 § 25.954 and amends part 25, appendix design and installation of fuel systems fuel tank structure and fuel tank 3 H, section H25.4(a) to require applicants prevent catastrophic fuel vapor ignition systems ). This amendment removes to establish airworthiness limitations to caused by lightning and its effects. This the requirement for prevention of protect the continued function of the performance-based standard allows lightning ignition sources from lightning protection features of fuel tank applicants to choose how to provide the § 25.981(a)(3), ‘‘Fuel tank ignition prevention,’’ at amendment 25–102 and structure and fuel systems. required level of safety. This action This rule applies to applications for requires airworthiness limitations to modifies § 25.954, ‘‘Fuel system lightning protection.’’ The modification new type certificates, and applications preclude the degradation of design for amended or supplemental type features that prevent catastrophic fuel to § 25.954 creates a performance-based standard that provides definitions for certificates on significant product-level vapor ignition caused by lightning. Its change projects in which § 25.954, intended effects are to align ‘‘critical lightning strike’’ and ‘‘fuel systems;’’ requires catastrophic fuel ‘‘Fuel system lightning protection,’’ is airworthiness standards with industry’s applicable to the changed area. and the FAA’s understanding of vapor ignition due to lightning and its lightning, and to address issues of II. Background inconsistency and impracticality that 1 Fuel system, in the context of this final rule, includes any component within either the fuel tank A. Statement of the Problem applicants experienced with previous structure or the fuel tank systems and any airplane lightning protection regulations. structure or system components that penetrate, Section 25.954, adopted in 1967, required protection of the airplane from DATES: Effective November 19, 2018. connect to, or are located within a fuel tank. 2 Fuel tank structure, in the context of this final the effects of lightning, regardless of the ADDRESSES: For information on where to rule, includes structural members of the fuel tank likelihood that lightning would strike obtain copies of rulemaking documents such as airplane skins, access panels, joints, ribs, the airplane. The regulation did not spars, stringers, and associated fasteners, brackets, and other information related to this acknowledge that lightning protection final rule, see ‘‘How To Obtain coatings, and sealant. 3 Fuel tank systems, or systems, in the context of Additional Information’’ in the this final rule, include tubing, components, and 4 See the ‘‘Large Airplane Fuel System Lightning SUPPLEMENTARY INFORMATION section of wiring that penetrate, connect to, or are located Protection Rulemaking Recommendations’’ report, this document. within a fuel tank. May 2011, available in the docket.

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features, or other features, could fail or On June 24, 2014, the FAA critical lightning strike, and fuel tank become ineffective. The regulation also superseded that policy memorandum flammability exposure; did not require evaluation of with Policy Statement PS–ANM– • Add maintenance requirements to probabilities of failures affecting 25.981–02, ‘‘Policy on Issuance of maintain the integrity of lightning lightning protection features, nor did it Special Conditions and Exemptions protection features during the airplane require maintenance actions to ensure Related to Lightning Protection of Fuel service life; and the continued effectiveness of design Tank Structure and Systems,’’ • Define critical lightning strike and features that prevent catastrophic fuel expanding the scope of the policy to fuel system. vapor ignition. include systems. The policy statement 2. ‘‘Fuel Tank Ignition Prevention,’’ Compliance with § 25.981(a)(3), at provided guidance for approval of (§ 25.981) 5 special conditions and exemptions for amendment 25–102, required the • assumption that lightning would strike lightning protection features in fuel tank Remove the requirement to prevent the airplane (i.e., that the probability of structure and fuel systems with respect lightning ignition sources and instead lightning was one) and that the design to § 25.981(a)(3). refer applicants to § 25.954 for lightning The revisions to § 25.981(a)(3) in this protection requirements; provide fail-safe ignition prevention • means to preclude ignition sources from amendment should eliminate the need Clarify that the applicant must being present in fuel tanks when to issue such special conditions and provide critical design control component failures, malfunctions, or exemptions. However, some of the configuration limitations (CDCCLs) to lightning strikes occur. This typically information in that policy statement identify critical design features in resulted in the need for triple-redundant will remain in Advisory Circular (AC) addition to inspections or other procedures; and lightning ignition protection features 25.981–1D, ‘‘Fuel Tank Ignition Source • because some structural failures may Prevention Guidelines,’’ 7 for this rule Change the title to ‘‘Fuel tank explosion prevention.’’ have long latency periods.6 The FAA because the FAA expects that the found, however, that for lightning information will continue to be useful 3. ‘‘Instructions for Continued protection, providing triple-redundant in ensuring the level of safety required Airworthiness,’’ Appendix H to Part 25 by the amended § 25.954 for fuel tank features is not always practical. This • Add a new paragraph to make structure and systems. impracticality has led applicants to mandatory any inspection and test apply for exemptions and special The final rule will maintain the level procedures that are needed to sustain conditions to ensure the design and of safety established by these policies. It the integrity of the lightning protection maintenance actions provide for, and codifies these policies into a design features used to show maintain, an acceptable level of safety. performance-based rule that allows the compliance with § 25.954; and However, the processing and issuance of applicant to choose the means of • Add a new section to require these exemptions and special conditions compliance. applicants to develop ICA that protect has created an administrative burden on C. Summary of the NPRM the lightning protection features industry and the FAA. required by § 25.954. On December 9, 2014, the FAA issued B. Related Actions The FAA proposed these changes a notice of proposed rulemaking based on recommendations from the On May 26, 2009, the FAA issued a (NPRM) to amend §§ 25.954 and 25.981 Lightning ARC. The comment period policy memorandum to standardize the and appendix H to part 25. The Federal closed on March 18, 2015. process for granting exemptions and Register published NPRM Notice No. issuing special conditions for fuel tank 14–09, Docket No. FAA–2014–1027, on III. Discussion of the Final Rule and structure lightning protection. FAA December 18, 2014. In the NPRM, the Public Comments Policy Memorandum ANM–112–08– FAA proposed the following changes: The FAA received comments from 002, ‘‘Policy on Issuance of Special 1. ‘‘Fuel System Lightning Protection,’’ eight (8) manufacturers and one (1) Conditions and Exemptions Related to (§ 25.954) industry group. All of the commenters Lightning Protection of Fuel Tank generally supported the proposed • Structure,’’ defined alternative methods Consolidate the requirements for amendments. Some of the comments that could be applied through special the prevention of fuel vapor ignition suggested changes. conditions or exemptions to some areas due to lightning, currently in §§ 25.954 In the discussion below, some of structural designs where compliance and 25.981, into § 25.954; comments identify paragraph • with § 25.981(a)(3) was impractical. Retain and renumber the existing designations of the rules as proposed in This policy allowed the applicant’s risk rule text; the NPRM. In this final rule, the FAA is assessment to account for the reduced • Add lightning-induced or revising and reorganizing some of those likelihood of the simultaneous conducted electrical transients 8 to the paragraphs, so paragraph references in occurrence of a critical lightning strike lightning effects that applicants must the comments may be different from and a fuel tank being flammable. The consider; their designation in the final rule. This policy explained the level of safety • Add a new performance-based section references each paragraph intended by § 25.981(a)(3) for fuel tank standard to require that a catastrophic according to its designation in this final structure, and provided guidance for fuel tank explosion be extremely rule, with the NPRM paragraph alternatives to compliance that still improbable when taking into account designation noted in brackets when achieve that level of safety. the risk of failures, probability of a there has been a change. A. ‘‘Fuel System Lightning Protection’’ 5 See 66 FR 23086 (May 7, 2001), ‘‘Transport 7 AC 25.981–1D is available in the docket and on Airplane Fuel Tank System Design Review, the internet at http://www.faa.gov/regulations_ (§ 25.954) Flammability Reduction, and Maintenance and policies/advisory_circulars/. With some differences from what the Inspection Requirements.’’ 8 As used in this discussion, a transient is a brief 6 In this context, latency period means the time electrical disturbance on wiring and equipment FAA proposed in the NPRM, this interval between a failure and the discovery of that caused by the intense voltage, current, and amendment requires that the design and failure. electromagnetic fields associate with lightning. installation of the airplane fuel system

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prevent catastrophic fuel vapor ignition The proposed definition of a ‘‘critical includes ‘‘any design feature or due to lightning and its effects. This lightning strike’’ was ‘‘. . . a lightning structure.’’ final rule removes ‘‘corona and strike that attaches to the airplane in a Related to the definition of critical streamering at fuel vent outlets’’ as a location that affects a failed feature or a lightning strike, the NPRM stated that a lightning effect that applicants must structural failure, and the amplitude of critical lightning strike occurs ‘‘on the consider, and adds ‘‘lightning-induced the strike is sufficient to create an order of once every 100,000 hours of or conducted electrical transients’’ to ignition source when combined with airplane operation.’’ The SAE Lightning the non-exclusive list of lightning that failure.’’ The SAE Lightning Group Group commented that the location of effects against which the fuel system requested changes to this definition for the lightning’s attachment to the must be protected. This amendment clarity. The commenter requested that airplane, whether the strike’s amplitude adds definitions for ‘‘critical lightning the term ‘‘failed feature’’ be changed to is sufficient to create an ignition source, strike’’ and ‘‘fuel system’’ to ensure ‘‘failed protection feature,’’ but did not and the effect of a failed feature or common understanding and consistent provide a rationale. The commenter also structural failure are all design- application of those terms. stated that it is unnecessary to list dependent. The SAE Lightning Group To comply with the revised § 25.954, structural failures separately. The also commented that compliance with this amendment requires applicants to commenter further stated that the § 25.954 would require use of a strike show that catastrophic fuel vapor inclusion of ‘‘a failed [protection] rate of 1 in 100,000 hours. The ignition is extremely improbable, taking feature’’ already includes structural commenter suggested that the FAA into account flammability, critical failures, which otherwise could result in should allow applicants to identify how lightning strikes, and failures within the an ignition source. The commenter also often a critical lightning strike might fuel system. suggested revising the definition to, ‘‘A occur relative to their designs. To protect those features of the critical lightning strike is a lightning The intent of the statement in the airplane that prevent catastrophic fuel strike that attaches to the airplane in a NPRM that a critical lightning strike vapor ignition due to lightning, this location that affects a failed protection occurs once per 100,000 hours was to amendment adds a requirement that the feature with characteristics that could provide a general understanding of their type design include CDCCLs identifying create an ignition source when average rate of occurrence. It was not those features and providing combined with that failure.’’ intended as a rate to be used in information to protect them. To ensure The FAA partially agrees with the demonstrating compliance. The FAA the continued effectiveness of those SAE Lightning Group’s requests. The agrees with the SAE Lightning Group features, the rule requires that the type FAA modified the definition of critical that the actual rate of a critical strike design specify necessary inspections lightning strike by deleting ‘‘the would be based on an applicant’s and test procedures, intervals between amplitude of the strike is sufficient,’’ analysis of the specific airplane design repetitive inspections and tests, and but did not replace that text with features, which include additional mandatory replacement times. The rule ‘‘characteristics that could,’’ as the factors such as location of the strike, also requires the applicant to include commenter recommended. The characteristics of the lightning strike, information regarding CDCCLs and definition is clear without either of failure of design features and structure, methods for ensuring continued those phrases. The FAA also did not and specific ignition source thresholds effectiveness of lightning protection replace ‘‘failed feature’’ with ‘‘failed for each feature failure and failure features in the Airworthiness protection feature,’’ or delete the phrase mode. Limitations section (ALS) of the ICA. ‘‘structural failure.’’ To address the Related to this same discussion in the The following is a discussion of comments, we have revised the NPRM, Parker Aerospace (‘‘Parker’’) comments the FAA received on the definition by removing the phrase requested that the FAA add a paragraph changes to § 25.954 as they were ‘‘failed feature’’ and stating instead that, to § 25.954 that describes all of the proposed in the NPRM. ‘‘A critical lightning strike is a lightning conditions and guidance regarding strike that attaches to the airplane in a 1. Definitions probabilities that the applicant must location that, when combined with the consider, such as flammability exposure The NPRM proposed adding failure of any design feature or and failure latency of inerting systems. definitions of ‘‘critical lightning strike’’ structure, could create an ignition The FAA disagrees with Parker’s and ‘‘fuel system’’ to § 25.954(d). This source.’’ request. Rather than make such final rule revises these definitions and In this revised definition, a ‘‘design conditions and guidance on moves them to paragraph (a) of the feature’’ means any feature specifically probabilities mandatory via a new section. designed for lightning protection or any paragraph in § 25.954, such guidance is The AE–2 and WG–31 Lightning other design feature whose failure, included in AC 25.954–1, ‘‘Transport Committees (SAE Lightning Group) when combined with a lightning strike, Airplane Fuel System Lightning supported the proposed definition of could cause ignition. An example of a Protection.’’ 9 The AC discusses the ‘‘fuel system.’’ However, the FAA design feature that is specifically probability for different airplane determined that the inclusion of the designed for lightning protection is a composite tank structures and threat word ‘‘other’’ in the definition, ‘‘A fuel metal foil layer installed between the levels. system includes any component within laminate layers of a composite wing. An either the fuel tank structure or the fuel example of a design feature that is not 2. Relationship of § 25.954 to §§ 25.901 tank systems, and any other airplane specifically designed for lightning and 25.1309 structure or system components that protection but whose failure, when The SAE Lightning Group suggested penetrate, connect to, or are located combined with a lightning strike, could that the FAA clearly state that the within a fuel tank,’’ could be cause ignition is a swaged fitting on a revised § 25.954 takes precedence over misinterpreted to exclude basic hydraulic tube located within the fuel the general requirements of §§ 25.901, structure, such as wings, in the context tank. Structural failures that could of the definition. Therefore, the create an ignition source in the event of 9 AC 25.954–1 is available in the docket and on definition of fuel system in the final rule a lightning strike must also be addressed the internet at http://www.faa.gov/regulations_ does not include ‘‘other.’’ and, therefore, the final definition policies/advisory_circulars/.

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‘‘Installation’’ (‘‘Subpart E— fuel vapor ignition due to lightning and limited the requirement to fault Powerplant’’), and 25.1309, its effects, including . . . .’’ tolerance as requested by the SAE ‘‘Equipment, systems, and The SAE Lightning Group Lightning Group, such a design installations.’’ The FAA disagrees. recommended the removal of ‘‘corona approach, or others as technology Section 25.954 does not supersede the and streamering at fuel vent outlets’’ progresses, would not be allowed. requirements of § 25.901 or § 25.1309. from the list of lightning effects because Regardless of the design approach However, compliance with § 25.954 may that term is inconsistent with the chosen by the applicant to prevent assist applicants in showing compliance terminology in the industry guidance lightning-induced catastrophic fuel with other regulations. material recommended by AC 20–155A. vapor ignition, a safety analysis will be The FAA agrees and has removed this necessary to demonstrate extreme 3. Lightning Effects term from the final rule. improbability. The complexity of the analysis can range from a relatively The NPRM proposed adding 4. Fault-Tolerant Design ‘‘lightning-induced or conducted simple assessment to establish any electrical transients’’ to the lightning Regarding § 25.954(c) [paragraph (b) maintenance requirements for reliable effects in § 25.954(b) [paragraph (a) in in the NPRM], the SAE Lightning Group fault-tolerant ignition protection the NPRM] that applicants must ensure requested that the FAA require that features, to a more in-depth analysis if catastrophic fuel vapor ignition due to will not cause ignition of fuel vapor non-fault-tolerant design features are lightning be prevented by demonstrating within the fuel system. The SAE used. For reliable fault-tolerant features, that the fuel system ignition source Lightning Group recommended that, this analysis would be substantially less protection design is fault tolerant, or for rather than adding to the existing list of costly than traditional methods for designs that are not fault tolerant, by lightning threats in the rule, the FAA showing that catastrophic failures are showing catastrophic fuel vapor ignition delete the list of lightning effects. extremely improbable. The supporting to be extremely improbable, taking into Instead, the SAE Lightning Group AC 25.954–1 provides guidance on account flammability, critical lightning recommended that the rule include a methods for both fault-tolerant and FRM strikes, and failures in the fuel system. more general and inclusive reference to compliance approaches, including the The SAE Lightning Group argued that lightning that requires that the airplane necessary safety assessment, which the proposed broader requirement to could be numerical, qualitative, or a be protected against catastrophic effects show that catastrophic ignition is from lightning. The SAE Lightning combination of the two. extremely improbable, without The FAA disagrees with Bombardier’s Group suggested that the list may not be requiring a fault tolerant design, would request to define fault-tolerant in complete and may be inconsistent with be costly and would negate the savings § 25.954. Since a fault-tolerant design is lightning environments defined in the to industry stated in the regulatory not a requirement for compliance with industry documents accepted by the evaluation. In a related comment, this rule, there is no need to provide a FAA in AC 20–155A, ‘‘Industry Bombardier S.A. (Bombardier) requested regulatory definition. However, the Documents to Support Aircraft that ‘‘fault tolerant’’ be defined to clarify supporting AC 25.954–1 includes the Lightning Protection Certification.’’ In if it is equivalent to single fault definition for fault-tolerant design noted contrast, Parker supported keeping the tolerance and the type of compliance earlier in this section (4. Fault-Tolerant text as proposed, including ‘‘lightning- that the FAA would expect, numerical Design), ‘‘A fault-tolerant fuel system induced or conducted electrical analysis or qualitative. Although the design is a design that precludes transients.’’ term was not used in the proposed rule ignition sources in the fuel system even The FAA disagrees with the SAE (and is not in the final rule), Bombardier when a fault is present.’’ Lightning Group’s suggestion to include suggested more clarity was needed in Therefore, this amendment retains the only a general lightning requirement. the rule and supporting guidance. requirement in § 25.954(c) that Relying on guidance material to detail The FAA agrees that fuel systems catastrophic fuel vapor ignition be the lightning effects that applicants designed with reliable fault-tolerant extremely improbable, and clarifies its must consider could result in some ignition source protection features relationship with paragraph (b). The applicants not addressing all effects. should comply with the requirement revised § 25.954(c) states, ‘‘To comply However, the FAA recognizes that the that catastrophic fuel vapor ignition be with paragraph (b) of this section, list of effects, as proposed, could be extremely improbable. As used in this catastrophic fuel vapor ignition must be misinterpreted as an exhaustive list. context, a fault-tolerant fuel system extremely improbable, taking into Therefore, the FAA added ‘‘including’’ design is a design that precludes account flammability, critical lightning to the text that introduces the list to ignition sources in the fuel system even strikes, and failures within the fuel clarify that the list is not exhaustive. when a fault is present; ‘‘reliable’’ system.’’ The FAA agrees to limit, in § 25.954(b), means the ability to maintain the The SAE Lightning Group also the type of fuel vapor ignition that must effectiveness of the protection features commented that the FAA should revise be prevented to ‘‘catastrophic’’ events. over the service life of the individual the regulatory evaluation if the FAA This change will make the requirement airplane. does not adopt the SAE Lightning consistent with Policy Statement PS– However, the FAA disagrees that fault Group’s recommendation to replace the ANM–25.981–02, which states that ‘‘the tolerance should be required because requirement of extreme improbability fuel tank structure and systems must be fault tolerance is only one possible with fault tolerance. The commenter designed and installed to prevent means of compliance with the argued that the requirement to show catastrophic fuel vapor ignition due to requirement that catastrophic fuel vapor that fuel tank ignition is extremely lightning.’’ This change also makes ignition be extremely improbable. The improbable would be costly and negate § 25.954(b) consistent with § 25.581, use of a full-time flammability control the savings to industry shown in the which requires that the airplane be system (e.g., fuel system inerting) regulatory evaluation. The SAE protected against ‘‘catastrophic’’ effects exceeding the current part 25 Lightning Group did not submit any from lightning. Thus, § 25.954(b) now flammability reduction means (FRM) supporting financial data. states, ‘‘The design and installation of a performance standard could be another The FAA does not agree that the fuel system must prevent catastrophic means of compliance. If the FAA requirement to show that fuel tank

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ignition is extremely improbable would the fuel tank being flammable, and the commenter stated that if the FAA does be costly and negate the savings to creation of an ignition source due to the not agree with this approach, then only industry. In general, an applicant that failure of fuel system or structural critical information necessary to can show its design is reliably fault- lightning protection features. If demonstrate compliance, along with tolerant will not need to conduct an designers develop a full-time fuel tank CDCCLs, should be included as extensive safety analysis. The flammability control system that airworthiness limitations, and proposed requirement to develop airworthiness prevents the fuel tanks from being that the regulatory text be amended to limitations for critical lightning flammable during all foreseeable reflect this request. The SAE Lightning protection features will result in the operating conditions and all phases of Group did not define what it considered need for the applicant to assess the airplane operation (including descent), critical information. reliability of the features and provide resulting in the probability of a fuel tank The FAA disagrees with the SAE appropriate maintenance tasks to explosion being extremely improbable, Lightning Group’s request to move the achieve an acceptable level of this could achieve the level of safety CDCCLs from the ALS of the ICA to the reliability. that § 25.954 requires, and could be Cautions section of the maintenance In addition, this rule allows both used as a means of compliance without manual. CDCCLs provide information fault-tolerant and non-fault-tolerant the need for fault-tolerant lightning that is essential for protecting the design design approaches. Under the rule, the protection features. While fuel tank features that are critical for preventing fuel system must prevent catastrophic flammability control system technology fuel tank explosions. The Caution fuel vapor ignition due to lightning. To has not evolved to a state where section of the maintenance manual is comply with this requirement, flammability control can replace the not mandatory for U.S. operators, and catastrophic fuel vapor ignition must be need for fault-tolerant ignition therefore CDCCLs need to be included extremely improbable. If an applicant’s prevention, the FAA’s goal is to develop in the ALS of the ICA, which is design achieves this requirement rules that are performance-based, and in mandatory. through the use of fault-tolerant design, this case, to allow designers to comply The SAE Lightning Group commented the safety analysis (§ 25.1309) to support via the use of flammability control when that, since the Lightning ARC study and the design will not have to be as the technology is adequately developed. report in 2011, the use of Air Transport extensive as one that would be Allowing the use of fuel tank FRM for Association (ATA) Maintenance necessary to support a non-fault-tolerant demonstrating compliance with the rule Steering Group (MSG)–3 11 processes design. As a result, the rule allows could offer designers the opportunity to has not been effective in establishing industry the flexibility to select the reduce the number of fault-tolerant maintenance requirements for lightning means of compliance based on design features and mandatory maintenance protection features and does not take approach, safety analysis, and costs. actions. into consideration the many factors that Therefore, the FAA determined that the are critical for certification. This can regulatory evaluation did not need to be 6. CDCCLs create conflicting or duplicate fuel tank revised as a result of this comment. Section 25.954(d) [paragraph (c) in the entry requirements. To eliminate this NPRM] requires that the type design potential duplication, the SAE 5. Flammability Reduction Means include CDCCLs identifying those Lightning Group stated that industry (FRM) as a Means of Compliance design features that prevent catastrophic now recommends that maintenance The SAE Lightning Group, fuel vapor ignition caused by lightning practices for both fault-tolerant and non- Bombardier, and Parker all commented and providing information to protect fault-tolerant protection features be on the discussion of fuel tank them. To ensure the continued established via the type certification flammability reduction in the NPRM effectiveness of those features, process only, and that the ATA MSG– and asked for clarification of how paragraph (d) also requires that the type 3 process should not be used for this flammability reduction could be used as design include inspections and test purpose. a means of compliance with § 25.954. procedures, intervals between repetitive Airbus and Airlines for America Boeing stated that the majority of the inspections and tests, and mandatory disagreed with the request to establish NPRM discussion of fuel tank FRM was replacement times. This paragraph also maintenance practices for both fault- unnecessary because applicants could requires applicants to place all this tolerant and non-fault-tolerant infer that the FAA would relax the information in the ALS of the ICA. protection features via the type requirement for providing fault The SAE Lightning Group proposed certification process. Both commenters tolerance if the FAA allowed FRM as a that CDCCLs be included as cautions 10 proposed that the FAA require sole means of compliance. Boeing did in the airplane maintenance manual, not airworthiness limitations and CDCCLs not agree that the FAA should accept as airworthiness limitations in the ALS for only non-fault-tolerant design controlling fuel tank flammability as the of the ICA. The SAE Lightning Group features. Both commenters stated that an primary means for preventing a fuel suggested that, as proposed, the airworthiness limitation requirement for tank explosion without providing fault- requirement would create a burden on fault-tolerant design features could be a tolerant lightning protection features. the airlines because the ALS documents disincentive to develop fault-tolerant As discussed in the previous section are not used by the airline mechanics, designs and may increase the burden on (4. Fault-Tolerant Design), the FAA does and therefore the CDCCL information operators unnecessarily. As an not agree that the lightning protection must be duplicated and links created for alternative, they proposed reliance on requirement in § 25.954 should dictate the information in both the ALS the current ATA MSG–3 process for the use of fault-tolerant ignition documents and the maintenance establishing maintenance programs for protection features in the design documents used by the mechanics. The without allowing the use of 11 ATA MSG–3 is a maintenance steering group flammability control means. As 10 Cautions in an airplane maintenance manual composed of regulatory authorities, operators, and explained in the NPRM, the intent of the call attention to methods and procedures that must manufacturers that, through a process, develop be followed to avoid damage to equipment (ATA documents that present a methodology for amendment to § 25.954 is to require the iSpec 2200, Information Standards for Aviation developing scheduled maintenance tasks and design to take into account the Maintenance, published by Airlines for America, intervals for aircraft structure, systems, and likelihood of a critical lightning strike, 2014). components.

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fault-tolerant design features. Airbus system lightning protection, it is not 2. CDCCL Visible Means also suggested that operational rules and practical to require installation of guidance could be established to visible means of identification for all Boeing requested that the FAA revise prevent tasks identified through the lightning-related CDCCLs. However, all § 25.981(d) to delete the requirement for ATA MSG–3 process from being deleted critical lightning protection features placement of visible means, limit that in service. identified as CDCCLs must be included placement to areas where the means The FAA agrees with the SAE in the ALS of the ICA. Although the would be ‘‘practical and meaningful,’’ or Lightning Group that all maintenance FAA made minor editorial changes 13 to provide more clear guidance. Boeing practices for both fault-tolerant and non- the final § 25.954(d), the requirement stated that, as proposed, the regulation fault-tolerant protection features be that the type design include CDCCLs is provides no practical way to fully established via the type certification adopted as proposed. comply with the requirement to provide process and not through the ATA MSG– visible means of identifying CDCCL. 3 process. Using the certification B. ‘‘Fuel Tank Explosion Protection’’ Boeing argued that, ‘‘While it may be process will ensure that applicants (§ 25.981) easy to pick the color of external fuel develop necessary maintenance actions Section 25.981 requires that the quantity wiring, much of the fuel tank to maintain the integrity of lightning airplane design protect the fuel tank and design for ignition prevention is basic to ignition source protection features. As fuel tank system against ignition from airplane design, such as bonding, all maintenance actions necessary to all sources. This amendment adds an grounding, sealing, etc. There is no ensure the integrity of lightning ignition exception to § 25.981(a)(3) to remove practical way to color code or otherwise source protection features will be lightning as an ignition source from the identify these design features.’’ addressed by compliance with section scope of this section and refers The FAA partially agrees. The intent H25.4(a)(5), the ICA requirement in the applicants to § 25.954 for lightning is not to require markings in all proposed section H25.X is not necessary protection requirements. locations—only in those locations and has been deleted from the final rule. Paragraph (d) of § 25.981 requires where foreseeable errors due to This is discussed further in the applicants to establish CDCCLs, maintenance actions, repairs, or discussion regarding appendix H. inspections, or other procedures to alterations may compromise critical The FAA disagrees with Airbus’ and features. This is not a new requirement Airlines for America’s proposal to rely ensure fuel tank safety. This amendment revises paragraph (d) to clarify that with this amendment. However, this on the ATA MSG–3 process for amendment deletes the example of development of maintenance actions for applicants must provide CDCCLs to identify critical design features, in visible means (color coding of wire to fault-tolerant design features. U.S. identify separation limitation), and it operators are not required to adopt the addition to inspections or other procedures. The FAA received the removes the requirement of identifying ATA MSG–3 developed maintenance visible means as CDCCLs, both of which program, but they are required to following comments on the proposed changes to this section. had been added at amendment 25–125. include all airworthiness limitations in AC 25.981–1D provides additional 12 their maintenance program. Therefore, 1. Consistency of Language guidance. airworthiness limitations are needed to ensure an operator’s maintenance Boeing suggested that the FAA C. ‘‘Instructions for Continued program includes all tasks determined expand the applicability of § 25.981(d) Airworthiness’’ (Appendix H to Part 25) by the safety analysis, performed as part to include the fuel tank system, in With some differences from what the of the system’s certification activity, to addition to the fuel tank, to be FAA proposed in the NPRM, this be critical. The safety analysis may consistent with § 25.981(a). Paragraph amendment adds a new paragraph, show that some fault-tolerant features (a) of § 25.981 requires ignition source (a)(5), to section H25.4 of appendix H to are life-limited or require periodic prevention in the ‘‘fuel tank or fuel tank part 25. This paragraph requires any inspection, so mandatory maintenance system.’’ mandatory replacement times, tasks established through engineering The FAA agrees and revised the final inspection intervals, related inspection review and approval would be needed. rule to add, ‘‘. . . or fuel tank system and test procedures, and CDCCLs for Therefore, the FAA did not change this according to paragraph (a) of this lightning protection features approved rule as a result of these comments. section. . . .’’ This addition makes it The SAE Lightning Group also stated consistent with § 25.981(a). under § 25.954 to be included in the ALS of the ICA. that the reference to § 25.1729 in Boeing proposed that § 25.981(d) refer § 25.954(d) is not within the scope of to paragraph (b) of that section in The SAE Lightning Group proposed this rule and requested that it be addition to the references to paragraphs revisions to the airworthiness limitation removed. The FAA agrees and removed (a) and (c) of that section because requirements of section H25.4(a)(5) by that reference from the final rule. mandatory maintenance required by adding the phrases ‘‘critical design Embraer suggested that § 25.954(d) paragraph (d) should also apply to configuration control limitations’’ and include the same requirement that is in flammability reduction means. ‘‘fault tolerant and non-fault tolerant.’’ The commenter stated that the revisions § 25.981(d). Section 25.981(d) requires The FAA agrees, and this amendment would align this paragraph with the the type design to include visible means includes a reference to paragraph (b) in SAE Lightning Group’s requested for identifying critical features in areas § 25.981(d). where foreseeable maintenance actions, changes to § 25.954 regarding fault- repairs, or alterations may compromise tolerant and non-fault tolerant designs. 13 The FAA deleted ‘‘on how’’ in the first the CDCCLs. Embraer stated that this sentence of the paragraph, ‘‘. . . (CDCCLs) The commenter also requested deletion would harmonize both requirements. identifying those features and providing of the proposed section H25.X, stating The FAA does not agree. Because of information on how to protect them,’’ and added that the MSG–3 process has been shown the large number and multiple types of ‘‘used in demonstrating compliance to paragraph (b) to be ineffective for maintenance of this section’’ in the second sentence, ‘‘. . . and bonding features used for fuel tank and mandatory replacement times for those design inspections and procedures that are features used in demonstrating compliance to critical to fuel tank systems lightning 12 Section H25.4(a) and 14 CFR 91.403(c). paragraph (b) of this section.’’ protection.

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Although Airbus was a participant in Section 25.899 specifically addresses or more annually (adjusted for inflation the SAE Lightning Group, it disagreed electrostatic charge, and § 25.981 with base year of 1995). This portion of with the above comments on section addresses all ignition sources, which the preamble summarizes the FAA’s H25.4(a)(5) because it makes reference would include electrostatic charge. analysis of the economic impacts of this to the ALS as being the only means to Lightning is the only exception, and it final rule. We suggest readers seeking develop the ICA for both fault-tolerant is now addressed by § 25.954. Adding a greater detail read the full regulatory and non-fault tolerant lightning specific requirement for electrostatic evaluation, a copy of which we have protection features. Airbus suggested charge to §§ 25.954 and 25.981 would be placed in the docket for this rulemaking. instead that the FAA limit the redundant and may cause confusion. In conducting these analyses, FAA applicability of section H25.4(a)(5) to Therefore, the FAA did not revise the has determined that this final rule: (1) non-fault-tolerant lightning protection rules because of this comment. Has benefits that justify its costs; (2) is features rather than to all lightning 2. Regulatory Evaluation not an economically ‘‘significant protection features. Airbus also asked regulatory action’’ as defined in section that the FAA delete the reference to Boeing requested that the FAA 3(f) of Executive Order 12866; (3) is not sampling programs in section H25.X. explain the assumption made in ‘‘significant’’ as defined in DOT’s Airbus stated that sampling programs paragraph IV.A.3 of the NPRM Regulatory Policies and Procedures; (4) are typically managed by the type preamble, ‘‘Regulatory Notices and will not have a significant economic certificate applicant, not the operator of Analyses, Regulatory Evaluation, impact on a substantial number of small the airplane that uses the ICA to Assumptions and Data Sources,’’ that entities; (5) will not create unnecessary develop their maintenance programs. computational weights of composite obstacles to the foreign commerce of the The FAA partially agrees with the wing airplanes would change from United States; and (6) will not impose SAE Lightning Group’s proposed current approximate 15%–25% level an unfunded mandate on state, local, or changes. The FAA does not agree to the linearly increasing to 50% level for a tribal governments, or on the private proposed changes to section H25.4(a)(5) ten-year production cycle. sector by exceeding the threshold as the FAA did not adopt the SAE The FAA clarified the information identified above. These analyses are Lightning Group’s requested changes to with the major manufacturer that had summarized below. § 25.954, with the exception of deleting provided the data during the reference to § 25.1729. However, the development of the NPRM regulatory 1. Total Benefits and Costs of This Rule FAA did add the term ‘‘critical design evaluation. The assumption is more This final rule will be relieving for configuration control limitations’’ to the correctly stated that the weighted both government and industries with final section H25.4(a)(5). Thus, section production rate of composite wing the estimated net benefits. The FAA H25.4(a)(5) now states, ‘‘Each airplanes is estimated at 15%–25% of assesses cost savings based on resources mandatory replacement time, inspection total production at the beginning of the saved for reducing regulatory burden on interval, and related inspection and test 10-year production cycle, increasing both industry and the FAA. This rule procedure, and each critical design linearly to 50% at the end of the cycle. results in cost savings by reducing the configuration control limitation for each IV. Regulatory Notices and Analyses number of exemptions and special lightning protection feature approved conditions. under § 25.954.’’ A. Regulatory Evaluation Over a 10-year period, the average The FAA agrees with the request to Changes to Federal regulations must total present value savings to delete the proposed new section H25.X undergo several economic analyses. manufacturers and the FAA are about because all necessary maintenance First, Executive Order 12866 and $29.03 million at a 7% discount rate actions for ensuring the integrity of Executive Order 13563 direct that each with annualized savings of about $4.13 lightning ignition source protection Federal agency shall propose or adopt a million. The lower and the higher features will be addressed by regulation only upon a reasoned estimates of the total present value compliance with section H25.4(a)(5). determination that the benefits of the savings are $16.17 million and $41.93 Therefore, the ICA requirement in the intended regulation justify its costs. million at a 7% discount rate, with proposed section H25.X is not Second, the Regulatory Flexibility Act annualized savings of $2.30 million and necessary, so that section is not of 1980 (Pub. L. 96–354) requires $5.97 million, respectively. The final included in the final rule. This also agencies to analyze the economic rule will maintain achieved safety levels addresses Airbus’s request to delete the impact of regulatory changes on small related to fuel tank structure and system reference to sampling programs in entities. Third, the Trade Agreements lightning protection commensurate with section H25.X. The FAA disagrees with Act (Pub. L. 96–39) prohibits agencies the current requirements. Airbus’s request to add the phrase ‘‘non- from setting standards that create Parties Potentially Affected by this fault-tolerant’’ to section H25.4(a)(5) unnecessary obstacles to the foreign Rulemaking will be: because all necessary maintenance commerce of the United States. In • actions, both fault-tolerant and non- Part 25 airplane manufacturers. developing U.S. standards, this Trade • Operators of part 25 airplanes. fault-tolerant, must be included in the Act requires agencies to consider • The Federal Aviation ALS as required by section H25.4(a)(5). international standards and, where Administration. D. Miscellaneous Comments appropriate, that they be the basis of U.S. standards. Fourth, the Unfunded Assumptions and Data Sources. • 1. Hazards of Electrostatic Charge Mandates Reform Act of 1995 (Pub. L. Data related to industry savings An individual suggested that the FAA 104–4) requires agencies to prepare a mainly come from airplane revise §§ 25.954 and 25.981 to include written assessment of the costs, benefits, manufacturers. a requirement for fuel system design and other effects of final rules that • Data related to requests for features to mitigate the hazards of include a Federal mandate likely to exemptions and special conditions electrostatic charge. The commenter result in the expenditure by State, local, come from FAA internal data sources stated that these design features would or tribal governments, in the aggregate, and the judgments of agency subject also have a role in lightning protection. or by the private sector, of $100 million matter experts.

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• The FAA would process 4 special always practical for transport category E. Paperwork Reduction Act conditions and 7 exemptions in the next airplanes regarding lightning protection 10 years in the absence of this rule.14 of fuel tanks and systems. This final rule The Paperwork Reduction Act of 1995 • Domestic airplane manufacturers provides burden relief and savings to (44 U.S.C. 3507(d)) requires that the would petition for two special airplane manufacturers, who are large FAA consider the impact of paperwork conditions and three exemptions before entities. Therefore, as provided in and other information collection reaching their cost-benefit steady- section 605(b), the head of the FAA burdens imposed on the public. The state.15 certifies that this final rule will not have FAA has determined that there is no • While foreign manufacturers may a significant economic impact on a new requirement for information benefit also from this final rule, cost substantial number of small entities and collection associated with this final savings directly attributable to foreign also certifies that a regulatory flexibility rule. entities are not included in this analysis is not required. The FAA F. International Compatibility analysis. solicited comments in the NPRM and • For the final rule, the FAA did not receive comments with regard to estimates cost savings from avoided In keeping with U.S. obligations this certification. Therefore, the FAA petitions for exemption and special under the Convention on International Administrator certifies that this rule conditions occur at the beginning of a Civil Aviation, it is FAA policy to does not have a significant economic 10-year production cycle. conform to International Civil Aviation • Projected impacts on manufacturers impact on a substantial number of small Organization (ICAO) Standards and and the government are for a 10-year entities. Recommended Practices to the period associated with one production C. International Trade Impact maximum extent practicable. The FAA cycle. has determined that there are no ICAO • Assessment All monetary values are expressed Standards and Recommended Practices in 2016 dollars. The Trade Agreements Act of 1979 that correspond to these regulations. B. Regulatory Flexibility Determination (Pub. L. 96–39), as amended by the Uruguay Round Agreements Act (Pub. G. Environmental Analysis The Regulatory Flexibility Act of 1980 L. 103–465), prohibits Federal agencies FAA Order 1050.1F identifies FAA (Pub. L. 96–354) (RFA) establishes ‘‘as a from establishing standards or engaging actions that are categorically excluded principle of regulatory issuance that in related activities that create from preparation of an environmental agencies shall endeavor, consistent with unnecessary obstacles to the foreign the objectives of the rule and of commerce of the United States. assessment or environmental impact applicable statutes, to fit regulatory and Pursuant to these Acts, the statement under the National informational requirements to the scale establishment of standards is not Environmental Policy Act in the of the businesses, organizations, and considered an unnecessary obstacle to absence of extraordinary circumstances. governmental jurisdictions subject to the foreign commerce of the United The FAA has determined this regulation.’’ To achieve this principle, States, so long as the standard has a rulemaking action qualifies for the agencies are required to solicit and legitimate domestic objective, such as categorical exclusion identified in consider flexible regulatory proposals the protection of safety, and does not paragraph 5–6.6 and involves no and to explain the rationale for their operate in a manner that excludes extraordinary circumstances. actions to assure that such proposals are given serious consideration.’’ The RFA imports that meet this objective. The V. Executive Order Determinations covers a wide-range of small entities, statute also requires consideration of A. Executive Order 13132, Federalism including small businesses, not-for- international standards and, where appropriate, that they be the basis for profit organizations, and small The FAA has analyzed this final rule governmental jurisdictions. U.S. standards. The FAA has assessed the potential effect of this final rule and under the principles and criteria of Agencies must perform a review to Executive Order 13132, Federalism. The determine whether a rule will have a determined that it could result in the same benefits to domestic and agency determined that this action will significant economic impact on a not have a substantial direct effect on substantial number of small entities. If international entities in accord with the the States, or the relationship between the agency determines that it will, the Trade Agreements Act. the Federal Government and the States, agency must prepare a regulatory D. Unfunded Mandates Assessment flexibility analysis as described in the or on the distribution of power and responsibilities among the various RFA. Title II of the Unfunded Mandates levels of government, and, therefore, However, if an agency determines that Reform Act of 1995 (Pub. L. 104–4) does not have Federalism implications. a rule is not expected to have a requires each Federal agency to prepare significant economic impact on a a written statement assessing the effects B. Executive Order 13211, Regulations substantial number of small entities, of any Federal mandate in a proposed or That Significantly Affect Energy Supply, section 605(b) of the RFA provides that final agency rule that may result in an Distribution, or Use the head of the agency may so certify expenditure of $100 million or more (in and a regulatory flexibility analysis is 1995 dollars) in any one year by State, The FAA analyzed this final rule not required. The certification must local, and tribal governments, in the under Executive Order 13211, Actions include a statement providing the aggregate, or by the private sector; such Concerning Regulations that factual basis for this determination, and a mandate is deemed to be a ‘‘significant Significantly Affect Energy Supply, the reasoning should be clear. regulatory action.’’ The FAA currently Distribution, or Use (May 18, 2001). The This final rule amends certain uses an inflation-adjusted value of $155 agency has determined that it is not a airworthiness regulations that were not million in lieu of $100 million. This ‘‘significant energy action’’ under the 14 FAA internal data source and the judgment of final rule does not contain such a executive order and it is not likely to agency subject matter experts. mandate; therefore, the requirements of have a significant adverse effect on the 15 See footnote 14. Title II of the Act do not apply. supply, distribution, or use of energy.

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C. Executive Order 13609, International advice about compliance with statutes (CDCCLs) identifying those features and Cooperation and regulations within its jurisdiction. providing information to protect them. Executive Order 13609, Promoting A small entity with questions regarding To ensure the continued effectiveness of International Regulatory Cooperation, this document, may contact its local those design features, the type design promotes international regulatory FAA official, or the person listed under must also include inspection and test cooperation to meet shared challenges the FOR FURTHER INFORMATION CONTACT procedures, intervals between repetitive involving health, safety, labor, security, heading at the beginning of the inspections and tests, and mandatory environmental, and other issues and to preamble. To find out more about replacement times for those design reduce, eliminate, or prevent SBREFA on the internet, visit http:// features used in demonstrating www.faa.gov/regulations_policies/ compliance to paragraph (b) of this unnecessary differences in regulatory _ requirements. The FAA has analyzed rulemaking/sbre act/. section. The applicant must include the information required by this paragraph this action under the policies and List of Subjects in 14 CFR Part 25 agency responsibilities of Executive in the Airworthiness Limitations section Aircraft, Aviation safety, Reporting Order 13609, and has determined that of the Instructions for Continued and recordkeeping requirements. this action would have no effect on Airworthiness required by § 25.1529. international regulatory cooperation. The Amendment ■ 3. Amend § 25.981 by revising the D. Executive Order 13771, Reducing In consideration of the foregoing, the section heading and paragraphs (a)(3) Regulation and Controlling Regulatory Federal Aviation Administration and (d) to read as follows: Costs amends chapter I of title 14, Code of § 25.981 Fuel tank explosion prevention. Federal Regulations as follows: This final rule is considered an E.O. (a) * * * 13771 deregulatory action. Details on PART 25—AIRWORTHINESS (3) Except for ignition sources due to the estimated cost savings of this rule STANDARDS: TRANSPORT lightning addressed by § 25.954, can be found in the rule’s economic CATEGORY AIRPLANES demonstrating that an ignition source analysis. could not result from each single failure, ■ 1. The authority citation for part 25 VI. How To Obtain Additional from each single failure in combination continues to read as follows: Information with each latent failure condition not Authority: 49 U.S.C. 106(f), 106(g), 40113, shown to be extremely remote, and from A. Rulemaking Documents 44701, 44702 and 44704. all combinations of failures not shown An electronic copy of a rulemaking ■ 2. Revise § 25.954 to read as follows: to be extremely improbable, taking into document may be obtained from the account the effects of manufacturing internet by— § 25.954 Fuel system lightning protection. variability, aging, wear, corrosion, and 1. Searching the Federal eRulemaking (a) For purposes of this section— likely damage. Portal (http://www.regulations.gov); (1) A critical lightning strike is a * * * * * 2. Visiting the FAA’s Regulations and lightning strike that attaches to the Policies web page at http:// airplane in a location that, when (d) To protect design features that www.faa.gov/regulations_policies/; or combined with the failure of any design prevent catastrophic ignition sources 3. Accessing the Government Printing feature or structure, could create an within the fuel tank or fuel tank system Office’s web page at http:// ignition source. according to paragraph (a) of this www.gpo.gov/fdsys/. (2) A fuel system includes any section, and to prevent increasing the Copies may also be obtained by component within either the fuel tank flammability exposure of the tanks sending a request (identified by notice, structure or the fuel tank systems, and above that permitted in paragraph (b) of amendment, or docket number of this any airplane structure or system this section, the type design must rulemaking) to the Federal Aviation components that penetrate, connect to, include critical design configuration Administration, Office of Rulemaking, or are located within a fuel tank. control limitations (CDCCLs) identifying ARM–1, 800 Independence Avenue SW, (b) The design and installation of a those features and providing Washington, DC 20591, or by calling fuel system must prevent catastrophic instructions on how to protect them. To (202) 267–9680. fuel vapor ignition due to lightning and ensure the continued effectiveness of its effects, including: those features, and prevent degradation B. Comments Submitted to the Docket (1) Direct lightning strikes to areas of the performance and reliability of any Comments received may be viewed by having a high probability of stroke means provided according to paragraphs going to http://www.regulations.gov and attachment; (a), (b), or (c) of this section, the type following the online instructions to (2) Swept lightning strokes to areas design must also include necessary search the docket number for this where swept strokes are highly inspection and test procedures, intervals action. Anyone is able to search the probable; and between repetitive inspections and tests, electronic form of all comments (3) Lightning-induced or conducted and mandatory replacement times for received into any of the FAA’s dockets electrical transients. those features. The applicant must by the name of the individual (c) To comply with paragraph (b) of include information required by this submitting the comment (or signing the this section, catastrophic fuel vapor paragraph in the Airworthiness comment, if submitted on behalf of an ignition must be extremely improbable, Limitations section of the Instructions association, business, labor union, etc.). taking into account flammability, for Continued Airworthiness required critical lightning strikes, and failures by § 25.1529. The type design must also C. Small Business Regulatory within the fuel system. include visible means of identifying Enforcement Fairness Act (d) To protect design features that critical features of the design in areas of The Small Business Regulatory prevent catastrophic fuel vapor ignition the airplane where foreseeable Enforcement Fairness Act (SBREFA) of caused by lightning, the type design maintenance actions, repairs, or 1996 requires FAA to comply with must include critical design alterations may compromise the small entity requests for information or configuration control limitations CDCCLs.

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■ 4. In appendix H to part 25, section objections will not be considered. and, except for those submitted as H25.4, add new paragraph (a)(5) to read Electronic objections must be submitted ‘‘Confidential Submissions,’’ publicly as follows: on or before October 22, 2018. The viewable at https://www.regulations.gov https://www.regulations.gov electronic or at the Dockets Management Staff Appendix H to Part 25—Instructions for filing system will accept objections until between 9 a.m. and 4 p.m., Monday Continued Airworthiness midnight Eastern Time at the end of through Friday. * * * * * October 22, 2018. Objections received • Confidential Submissions—To H25.4 Airworthiness Limitations section. by mail/hand delivery/courier (for submit an objection with confidential (a) * * * written/paper submissions) will be information that you do not wish to be (5) Each mandatory replacement time, considered timely if they are made publicly available, submit your inspection interval, and related inspection postmarked or the delivery service objections only as a written/paper and test procedure, and each critical design acceptance receipt is on or before that submission. You should submit two configuration control limitation for each date. copies total. One copy will include the lightning protection feature approved under information you claim to be confidential Electronic Submissions § 25.954. with a heading or cover note that states * * * * * Submit electronic objections in the ‘‘THIS DOCUMENT CONTAINS following way: CONFIDENTIAL INFORMATION.’’ We Issued under authority provided by 49 • U.S.C. 106(f), 44701(a), and 44703 in Federal eRulemaking Portal: will review this copy, including the Washington, DC, on September 6, 2018. https://www.regulations.gov. Follow the claimed confidential information, in our Carl Burleson, instructions for submitting comments. consideration of comments. The second Objections submitted electronically, Acting Deputy Administrator. copy, which will have the claimed including attachments, to https:// [FR Doc. 2018–20174 Filed 9–19–18; 8:45 am] confidential information redacted/ www.regulations.gov will be posted to blacked out, will be available for public BILLING CODE 4910–13–P the docket unchanged. Because your viewing and posted on https:// objection will be made public, you are www.regulations.gov. Submit both solely responsible for ensuring that your copies to the Dockets Management Staff. DEPARTMENT OF HEALTH AND objection does not include any If you do not wish your name and HUMAN SERVICES confidential information that you or a contact information to be made publicly third party may not wish to be posted, Food and Drug Administration available, you can provide this such as medical information, your or information on the cover sheet and not anyone else’s Social Security number, or 21 CFR Part 172 in the body of your comments and you confidential business information, such must identify this information as [Docket No. FDA–2017–F–3717] as a manufacturing process. Please note ‘‘confidential.’’ Any information marked that if you include your name, contact as ‘‘confidential’’ will not be disclosed Food Additives Permitted for Direct information, or other information that except in accordance with 21 CFR 10.20 Addition to Food for Human identifies you in the body of your and other applicable disclosure law. For Consumption; Vitamin D 3 objection, that information will be more information about FDA’s posting posted on https://www.regulations.gov. AGENCY: Food and Drug Administration, • of comments to public dockets, see 80 HHS. If you want to submit an objection FR 56469, September 18, 2015, or access with confidential information that you ACTION: Final rule. the information at: https://www.gpo.gov/ do not wish to be made available to the fdsys/pkg/FR-2015-09-18/pdf/2015- SUMMARY: The Food and Drug public, submit the objection as a 23389.pdf. Administration (FDA or we) is written/paper submission and in the Docket: For access to the docket to amending the food additive regulation manner detailed (see ‘‘Written/Paper read background documents or the Submissions’’ and ‘‘Instructions’’). for vitamin D3 to replace the current electronic and written/paper comments Reference Daily Intake (RDI) percentage Written/Paper Submissions received, go to https:// values of calcium in 100 percent fruit www.regulations.gov and insert the Submit written/paper submissions as juices and fruit juice drinks with docket number, found in brackets in the follows: absolute values and to update the • Mail/Hand Delivery/Courier (for heading of this document, into the reference for vitamin D specifications. 3 written/paper submissions): Dockets ‘‘Search’’ box and follow the prompts We are taking this action in response to Management Staff (HFA–305), Food and and/or go to the Dockets Management a food additive petition filed by the Drug Administration, 5630 Fishers Staff, 5630 Fishers Lane, Rm. 1061, Juice Products Association. Lane, Rm. 1061, Rockville, MD 20852. Rockville, MD 20852. DATES: This rule is effective September • For written/paper objections FOR FURTHER INFORMATION CONTACT: 20, 2018. Submit either electronic or submitted to the Dockets Management Judith Kidwell, Center for Food Safety written objections and requests for a Staff, FDA will post your objection, as and Applied Nutrition (HFS–265), Food hearing on the final rule by October 22, well as any attachments, except for and Drug Administration, 5001 Campus 2018. The Director of the Federal information submitted, marked and Dr., College Park, MD 20740–3835, 240– Register approves the incorporation by identified, as confidential, if submitted 402–1071. reference of certain publications listed as detailed in ‘‘Instructions.’’ SUPPLEMENTARY INFORMATION: in the rule as of September 20, 2018. See Instructions: All submissions received the ADDRESSES section and the must include the Docket No. FDA– I. Background OBJECTIONS section IX of this 2017–F–3717 for ‘‘Food Additives In the Federal Register of July 26, document for further information on Permitted for Direct Addition to Food 2017 (82 FR 34615), amended August filing objections. for Human Consumption; Vitamin D3 22, 2017 (82 FR 39711), we announced ADDRESSES: You may submit objections Final Rule.’’ Received objections, those that we filed a food additive petition and requests for a hearing as follows. filed in a timely manner (see (FAP 7A4818) submitted on behalf of Please note that late, untimely filed ADDRESSES), will be placed in the docket the Juice Products Association by Hogan

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Lovells US LLP, Columbia Square, 555 specified in 21 CFR 171.1 and 171.100 dietary exposure to vitamin D3 or to Thirteenth Street NW, Washington, DC for submitting such petitions calcium. Therefore, we have determined 20004. The petition proposed to amend (§ 171.130(b)). that there are no safety concerns as a the food additive regulations in In the Federal Register of February result of the proposed amendment. § 172.380 (21 CFR 172.380), Vitamin D3, 27, 2003 (68 FR 9000), we issued the Additionally, the current regulation to replace the currently specified regulations at § 172.380(c)(1) and (2) for the use of vitamin D3 in food minimum RDI percentage values of permitting the use of vitamin D3 in (§ 172.380) indicates that the additive calcium in calcium-fortified 100 percent calcium fortified 100 percent fruit juices must meet the specifications in the 9th fruit juices and fruit juice drinks with and fruit juice drinks. We took that edition of the Food Chemicals Codex absolute values. Specifically, action in response to a food additive (FCC 9). The petitioner requested that § 172.380(c)(1) currently provides for petition (FAP 2A4734) from the Minute we update the specifications for vitamin the use of vitamin D3 at a level not to Maid Co. (Minute Maid). Minute Maid D3 in § 172.380 by replacing the existing exceed 100 International Units (IU) per petitioned for vitamin D3 to be allowed FCC 9 reference with the 10th edition of 240 milliliters (mL) in 100 percent fruit to be added to calcium-fortified 100 the Food Chemicals Codex (FCC 10), the juices that are fortified with greater than percent fruit juices and fruit juice drinks most recent edition at the time the or equal to 33 percent of the RDI of so that the calcium and vitamin D levels petition was submitted. The calcium per 240 mL, excluding fruit are comparable to the levels in milk. specifications for vitamin D3 in FCC 10 juices that are specifically formulated or When we issued these regulations in are identical to those in FCC 9. processed for infants. In addition, 2003, the RDI for calcium was 1,000 mg; However, since we received the § 172.380(c)(2) provides for the use of however, in the Federal Register of May petition, FCC has been updated to the up to 100 IU of vitamin D3 per 240 mL 27, 2016 (81 FR 33742), we issued a 11th edition (FCC 11). The in fruit juice drinks that are fortified final rule which, among other things, specifications for vitamin D3 in FCC 11 with greater than or equal to 10 percent redefined the RDI of calcium for adults are identical to those in FCC 10. of the RDI of calcium per 240 mL, and children 4 years of age and older to Therefore, we are amending § 172.380 excluding fruit juice drinks that are 1,300 mg (21 CFR 101.9(c)(8)(iv)). by adopting the specifications for specifically formulated or processed for Because of the change in the RDI for vitamin D3 in FCC 11 in place of FCC infants. The petitioner proposed to calcium, the minimum level of added 9, because FCC 11 is the most current replace the RDI percentage values of calcium in 100 percent fruit juice that version. may be fortified with vitamin D calcium in 100 percent fruit juices and 3 III. Incorporation by Reference fruit juice drinks in these regulations increased from 330 mg to 430 mg and with the absolute values of added in fruit juice drinks from 100 mg to 130 FDA is incorporating by reference the calcium of 330 milligrams (mg) and 100 mg. monograph from Food Chemicals mg per 240 mL, respectively. The The Juice Products Association stated Codex, 11th ed., 2018, pp. 1243–1244 petitioner also requested that we update that the proposed revision of § 172.380 (vitamin D3), which is approved by the the reference for specifications for to specify absolute values of calcium on Director of the Office of the Federal vitamin D3 in § 172.380(b) from the 9th a mg/mL basis rather than a percentage Register. You may purchase a copy of edition of the Food Chemicals Codex of RDI is needed to maintain the relative the material from the United States (FCC 9) to the 10th edition (FCC 10). parity between fortified 100 percent Pharmacopeial Convention, 12601 fruit juices and fruit juice drinks and Twinbrook Pkwy., Rockville, MD 20852, II. Evaluation of Petition many dairy products. Without this 1–800–227–8772, http://www.usp.org/. Section 409(i) of the Federal Food, change, the petitioner stated that 100 Copies also may be examined at FDA’s Drug, and Cosmetic Act (FD&C Act) (21 percent fruit juices with vitamin D3 Main Library, 10903 New Hampshire U.S.C. 348(i)) states that we shall, by would have higher calcium levels than Ave., Bldg. 2, Third Floor, Silver Spring, regulation, establish the procedure for milk. The petitioner also stated that the MD 20993, 301–796–2039. amending or repealing a food additive higher levels of calcium resulting from The FCC monograph establishes the regulation, and that this procedure shall the redefined RDI for calcium present standard for purity and identity for conform to the procedure provided in formulation challenges and may vitamin D3. The monograph provides section 409 of the FD&C Act. Our adversely impact the taste of the juice or specifications and analytical regulations specific to administrative juice drink, which could deter methodologies used to identify the actions for food additives provide that consumers from selecting calcium and substance and establish acceptable the Commissioner of Food and Drugs, vitamin D fortified juices. Therefore, the purity criteria. To ensure that only food on his own initiative or on the petition petitioner proposed that § 172.380 be grade vitamin D3 is used in foods listed of any interested person, may propose amended to express the allowable added in § 172.380, the additive must meet the the issuance of a regulation amending or calcium levels on a mg basis consistent specifications and identity in the FCC repealing a regulation pertaining to a with the calcium levels before the monograph. food additive (§ 171.130(a) (21 CFR revision of the RDI for calcium. In doing 171.130(a))). The regulations further so, the allowable levels of calcium and IV. Conclusion provide that any such petition must vitamin D in 100 percent fruit juices and Based on data and information in the include an assertion of facts, supported juice drinks would again be comparable petition, we conclude that amending the by data, showing that new information to the levels in milk. food additive regulations in the exists with respect to the food additive Because the petitioner sought to regulation for vitamin D3 to replace the or that new uses have been developed revise the existing regulation to restore current RDI percentage values of or old uses abandoned, that new data the amount of calcium fortification calcium in 100 percent fruit juices and are available as to toxicity of the required to levels on par with milk, fruit juice drinks with absolute values is chemical, or that experience with the without introducing new uses for safe and appropriate. Thus, the RDI existing regulation or exemption may vitamin D3 or changing the levels of percentage values of calcium in 100 justify its amendment or repeal. New vitamin D3 and calcium that were percent fruit juices and fruit juice drinks data submitted as a food additive considered when the regulations were in these regulations are replaced with petition must be furnished in the form established, there is no increase in the absolute values of added calcium of

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330 mg and 100 mg per 240 mL, under the Paperwork Reduction Act of Any objections received in response respectively. Consequently, we are 1995 is not required. to the regulation may be seen in the amending the food additive regulations Dockets Management Staff between 9 VIII. Section 301(ll) of the Federal as set forth in this document. a.m. and 4 p.m., Monday through Food, Drug, and Cosmetic Act Additionally, the current regulation Friday, and will be posted to the docket Our review of this petition was for the use of vitamin D3 in food at https://www.regulations.gov. limited to section 409 of the FD&C Act. (§ 172.380) indicates that the additive List of Subjects in 21 CFR Part 172 must meet the specifications in FCC 9. This final rule is not a statement The more current version is FCC 11, regarding compliance with other Food additives, Incorporation by which contains specifications for sections of the FD&C Act. For example, reference, Reporting and recordkeeping vitamin D that are identical to those in section 301(ll) of the FD&C Act (21 requirements. 3 U.S.C. 331(ll)) prohibits the FCC 9. We are amending § 172.380 by Therefore, under the Federal Food, introduction or delivery for introduction adopting the specifications for vitamin Drug, and Cosmetic Act and under into interstate commerce of any food D3 in FCC 11 in place of FCC 9. authority delegated to the Commissioner that contains a drug approved under of Food and Drugs, 21 CFR part 172 is V. Public Disclosure section 505 of the FD&C Act (21 U.S.C. amended as follows: 355), a biological product licensed In accordance with § 171.1(h) (21 CFR under section 351 of the Public Health 171.1(h)), the petition and the PART 172—FOOD ADDITIVES Service Act (42 U.S.C. 262), or a drug or documents that we considered and PERMITTED FOR DIRECT ADDITION biological product for which substantial relied upon in reaching our decision to TO FOOD FOR HUMAN clinical investigations have been approve the petition will be made CONSUMPTION instituted and their existence has been available for public disclosure (see FOR made public, unless one of the ■ FURTHER INFORMATION CONTACT). As 1. The authority citation for part 172 exemptions in section 301(ll)(1) to (4) of continues to read as follows: provided in § 171.1(h), we will delete the FD&C Act applies. In our review of from the documents any materials that Authority: 21 U.S.C. 321, 341, 342, 348, this petition, we did not consider 371, 379e. are not available for public disclosure. whether section 301(ll) of the FD&C Act VI. Analysis of Environmental Impact or any of its exemptions apply to food ■ 2. Amend § 172.380 by revising containing this additive. Accordingly, paragraphs (b) and (c)(1) through (2) to We previously considered the this final rule should not be construed read as follows: environmental effects of this rule, as to be a statement that a food containing § 172.380 Vitamin D . stated in the July 26, 2017, Federal this additive, if introduced or delivered 3 Register notice of filing (82 FR 34615). for introduction into interstate * * * * * We stated in the notice of filing that we commerce, would not violate section (b) Vitamin D3 meets the had determined, under 21 CFR 25.30(i), 301(ll) of the FD&C Act. Furthermore, specifications of ‘‘Vitamin D3,’’, Food that this action ‘‘is of a type that does this language is included in all food Chemicals Codex, 11th ed., copyright not individually or cumulatively have a additive final rules and therefore should 2018, pp. 1243–1244, which is significant effect on the human not be construed to be a statement of the incorporated by reference. The Director environment because the amendments likelihood that section 301(ll) of the of the Office of the Federal Register are administrative in nature’’ such that FD&C Act applies. approves this incorporation by reference neither an environmental assessment in accordance with 5 U.S.C. 552(a) and nor an environmental impact statement IX. Objections 1 CFR part 51. You may obtain copies is required. Upon further consideration, If you will be adversely affected by from the United States Pharmacopeial we determined that FAP 7A4818 is not one or more provisions of this Convention, 12601 Twinbrook Pkwy., solely administrative in nature as this regulation, you may file with the Rockville, MD 20852 (internet address revision has the potential to lead to Dockets Management Staff (see http://www.usp.org). Copies may be manufacturing changes. Consequently, ADDRESSES) either electronic or written examined at the Food and Drug the action being requested is neither a objections. You must separately number Administration’s Main Library, 10903 correction nor technical change and the each objection, and within each New Hampshire Ave., Bldg. 2, Third original categorical exclusion (21 CFR numbered objection you must specify Floor, Silver Spring, MD 20993, 301– 25.30(i)) is not appropriate. Therefore, with particularity the provision(s) to 796–2039, or at the National Archives we have determined under 21 CFR which you object, and the grounds for and Records Administration (NARA). 25.32(k) that this action is of a type that your objection. Within each numbered For information on the availability of does not individually or cumulatively objection, you must specifically state this material at NARA, call 202–741– have a significant effect on the human whether you are requesting a hearing on 6030, or go to: http://www.archives.gov/ environment because the added vitamin the particular provision that you specify federal-register/cfr/ibr-locations.html. D3 and calcium will remain in the fruit in that numbered objection. If you do (c) * * * juice and fruit juice drinks through not request a hearing for any particular (1) At levels not to exceed 100 ingestion by consumers and neither objection, you waive the right to a International Units (IU) per 240 food additive is intended to replace hearing on that objection. If you request milliliters (mL) in 100 percent fruit macronutrients. Therefore, neither an a hearing, your objection must include juices (as defined under § 170.3(n)(35) environmental assessment nor an a detailed description and analysis of of this chapter) that are fortified with environmental impact statement is the specific information you intend to greater than or equal to 330 milligrams required. present in support of the objection in (mg) of calcium per 240 mL, excluding the event that a hearing is held. If you fruit juices that are specially formulated VII. Paperwork Reduction Act of 1995 do not include such a description and or processed for infants. This final rule contains no collection analysis for any particular objection, (2) At levels not to exceed 100 IU per of information. Therefore, clearance by you waive the right to a hearing on the 240 mL in fruit juice drinks (as defined the Office of Management and Budget objection. under § 170.3(n)(35) of this chapter) that

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are fortified with greater than or equal I. Table of Abbreviations leaf bascule bridge that has a vertical to 100 mg of calcium per 240 mL, CFR Code of Federal Regulations clearance of 21 feet at mean high water excluding fruit juice drinks that are DHS Department of Homeland Security in the closed position. The Southern specially formulated or processed for FR Federal Register Boulevard (SR 700/80) Bridge, mile infants. OMB Office of Management and Budget 1024.7, across the AICW (Lake Worth * * * * * NPRM Notice of proposed rulemaking Lagoon) at West Palm Beach, Florida is (Advance, Supplemental) Dated: September 13, 2018. under construction, a temporary lift § Section bridge is in place that has a vertical Leslie Kux, U.S.C. United States Code clearance of 14 feet at mean high water Associate Commissioner for Policy. FL Florida FDOT Florida Department of in the closed position and a 65 foot [FR Doc. 2018–20375 Filed 9–19–18; 8:45 am] Transportation vertical clearance in the open position. BILLING CODE 4164–01–P AICW Atlantic Intracoastal Waterway The existing regulations are published in 33 CFR 117.261(u), Flagler Memorial II. Background Information and Bridge, § 117.261(v) Royal Park Bridge, Regulatory History DEPARTMENT OF HOMELAND and § 117.261(w) Southern Boulevard SECURITY On August 17, 2017, the Coast Guard Bridge. published a notice of deviation from Coast Guard The bridge owner, Florida Department drawbridge regulation with request for of Transportation, requested changes to comments in the Federal Register (82 33 CFR Part 117 the drawbridge operating schedules to FR 39019) to test proposed changes. better facilitate orderly vehicle traffic [Docket No. USCG–2017–0273] Three comments were received. Due to flow across the Flagler Memorial, Royal delays in processing this proposed RIN 1625–AA09 Park and Southern Boulevard bridges regulatory change, on March 6, 2018, when the President of the United States, Drawbridge Operation Regulation; the Coast Guard published a notice of members of the First Family, or other Atlantic Intracoastal Waterway, Palm deviation from regulations with request persons under the protection of the for comments extension in the Federal Beach, FL Secret Service visit Mar-a-Lago. The Register (82 FR 9431) to allow for increase in traffic congestion occurs AGENCY: Coast Guard, DHS. additional time for the public to when the Presidential Security Zone (82 ACTION: Final rule. comment. One comment was received. FR 17295) is enforced which closes the On May 21, 2018, the Coast Guard Southern Boulevard Bridge when the SUMMARY: The Coast Guard is modifying published a notice of proposed the operating schedule that governs the presidential motorcade is in transit. rulemaking (NPRM) entitled Drawbridge This action requires through traffic to operation of the Flagler Memorial (SR Operation Regulation; Atlantic use the Flagler Memorial and Royal Park A1A) Bridge, mile 1021.8, the Royal Intracoastal Waterway, Palm Beach, FL Bridges. Park (SR 704) Bridge, mile 1022.6, and in the Federal Register (83 FR 23398). the Southern Boulevard (SR 700/80) No comments were received. Due to IV. Discussion of Comments, Changes Bridge, mile 1024.7, across the Atlantic delays in processing this regulatory and the Final Rule Intracoastal Waterway, at West Palm change, on June 25, 2018, the Coast As noted above, we received four Beach, Florida. This modification Guard published a notice of deviation allows the Flagler Memorial, Royal Park from regulations with request for comments total on the two notices of and Southern Boulevard Bridges to comments extension in the Federal deviation published on August 17, 2017 operate on alternative schedules when Register (83 FR 29438) to allow and March 6, 2018, respectively. Of the the President of the United States, additional time for public comment and four comments received, one was a members of the First Family, or other to evaluate the changes to the operating political statement with no relevance on persons under the protection of the schedules with the establishment of the the proposed regulation. Three of the Secret Service visit Mar-a-Lago. The Presidential Security Zone (82 FR four comments received were in favor of modifications are necessary to 17295). No comments were received. the regulation. Two of the comments in accommodate the increase in vehicular We are issuing rule under 5 U.S.C. favor of the regulation suggested the traffic when the presidential motorcade 553(d)(3), the Coast Guard finds that changes be made permanent regardless is in transit. good cause exists for making this rule of presidential visits. The Coast Guard has considered this recommendation, DATES: This rule is effective on effective in less than 30 days after however, making the modified operating September 20, 2018. publication in the Federal Register. The schedule permanent would place an ADDRESSES: To view documents notice of deviation published in the Federal Register (83 FR 29438) expires unreasonable burden on navigation and mentioned in this preamble as being potentially have a negative impact on available in the docket, go to http:// on August 29, 2018 and this rule must be in effect immediately thereafter. safe navigation. The modified schedule www.regulations.gov. Type USCG– is only in effect when uninterrupted 2017–0273 in the ‘‘SEARCH’’ box and III. Legal Authority and Need for Rule transit of dignitaries are crossing the click ‘‘SEARCH.’’ Click on Open Docket The Coast Guard is issuing this rule Southern Boulevard Bridge. While Folder on the line associated with this under authority 33 U.S.C. 499. The vessels may have to wait up to an hour, rulemaking. Flagler Memorial (SR A1A) Bridge, mile it is only during the weekdays and for FOR FURTHER INFORMATION CONTACT: If 1021.8, across the AICW (Lake Worth a short period. you have questions on this rule, call or Lagoon) at West Palm Beach, Florida is V. Regulatory Analyses email CWO4 Robert Wooten, Coast a double-leaf bascule bridge that has a Guard Sector Miami, FL, Waterways vertical clearance of 22 feet at mean We developed this rule after Management Division, telephone 305– high water in the closed position. The considering numerous statutes and 535–4311, email robert.a.wooten@ Royal Park (SR 704) Bridge, mile 1022.6, Executive Orders related to rulemaking. uscg.mil. across the AICW (Lake Worth Lagoon) at Below we summarize our analyses SUPPLEMENTARY INFORMATION: West Palm Beach, Florida is a double- based on a number of these statutes and

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Executive Orders, and we discuss First listed in the FOR FURTHER INFORMATION F. Environment Amendment rights of protesters. CONTACT, above. We have analyzed this rule under A. Regulatory Planning and Review Small businesses may send comments Department of Homeland Security on the actions of Federal employees Management Directive 023–01 and Executive Orders 12866 and 13563 who enforce, or otherwise determine Commandant Instruction M16475.lD, direct agencies to assess the costs and compliance with, Federal regulations to which guides the Coast Guard in benefits of available regulatory the Small Business and Agriculture complying with the National alternatives and, if regulation is Regulatory Enforcement Ombudsman Environmental Policy Act of 1969 necessary, to select regulatory and the Regional Small Business (NEPA) (42 U.S.C. 4321–4370f), and approaches that maximize net benefits. Regulatory Fairness Boards. The have made a determination that this Executive Order 13771 directs agencies Ombudsman evaluates these actions action is one of a category of actions to control regulatory costs through a annually and rates each agency’s which do not individually or budgeting process. This rule has not responsiveness to small business. If you cumulatively have a significant effect on been designated a ‘‘significant wish to comment on actions by the human environment. This rule regulatory action,’’ under Executive employees of the Coast Guard, call 1– simply promulgates the operating Order 12866. Accordingly, it has not 888–REG–FAIR (1–888–734–3247). The regulations or procedures for been reviewed by the Office of Coast Guard will not retaliate against drawbridges. This action is categorically Management and Budget (OMB) and small entities that question or complain excluded from further review, under pursuant to OMB guidance it is exempt about this rule or any policy or action figure 2–1, paragraph (32)(e), of the from the requirements of Executive of the Coast Guard. Instruction. Order 13771. A Record of Environmental C. Collection of Information This regulatory action determination Consideration and a Memorandum for is based on the ability that vessels able This rule calls for no new collection the Record are not required for this rule. to pass through the Flagler Memorial of information under the Paperwork G. Protest Activities and Royal Park Bridges in the closed Reduction Act of 1995 (44 U.S.C. 3501– position may do so at any time. The 3520). The Coast Guard respects the First bridges will be able to open for Amendment rights of protesters. D. Federalism and Indian Tribal emergencies. The Southern Boulevard Protesters are asked to contact the Government Bridge will be under the control of the person listed in the FOR FURTHER on-scene designated representative A rule has implications for federalism INFORMATION CONTACT section to when the Presidential Security Zone is under Executive Order 13132, coordinate protest activities so that your enforced. Federalism, if it has a substantial direct message can be received without effect on the States, on the relationship jeopardizing the safety or security of B. Impact on Small Entities between the national government and people, places or vessels. The Regulatory Flexibility Act of 1980 the States, or on the distribution of List of Subjects in 33 CFR Part 117 (RFA), 5 U.S.C. 601–612, as amended, power and responsibilities among the Bridges. requires federal agencies to consider the various levels of government. We have potential impact of regulations on small analyzed this rule under that Order and For the reasons discussed in the entities during rulemaking. The term have determined that it is consistent preamble, the Coast Guard amends 33 ‘‘small entities’’ comprises small with the fundamental federalism CFR part 117 as follows: businesses, not-for-profit organizations principles and preemption requirements PART 117—DRAWBRIDGE that are independently owned and described in Executive Order 13132. OPERATION REGULATIONS operated and are not dominant in their Also, this rule does not have tribal fields, and governmental jurisdictions implications under Executive Order ■ 1. The authority citation for part 117 with populations of less than 50,000. 13175, Consultation and Coordination continues to read as follows: The Coast Guard received zero with Indian Tribal Governments, comments from the Small Business Authority: 33 U.S.C. 499; 33 CFR 1.05–1; because it does not have a substantial Department of Homeland Security Delegation Administration on this rule. The Coast direct effect on one or more Indian No. 0170.1. Guard certifies under 5 U.S.C. 605(b) tribes, on the relationship between the ■ 2. Amend § 117.261 by revising that this rule will not have a significant Federal Government and Indian tribes, paragraphs (u), (v), and (w) to read as economic impact on a substantial or on the distribution of power and follows: number of small entities. responsibilities between the Federal While some owners or operators of Government and Indian tribes. § 117.261 Atlantic Intracoastal Waterway vessels intending to transit the bridge From St. Marys River to Key Largo. E. Unfunded Mandates Reform Act may be small entities, for the reasons * * * * * stated in section V.A above, this rule The Unfunded Mandates Reform Act (u) Flagler Memorial (SR A1A) Bridge, will not have a significant economic of 1995 (2 U.S.C. 1531–1538) requires mile 1021.8, at West Palm Beach. (1) impact on any vessel owner or operator. Federal agencies to assess the effects of The draw shall open on the quarter and Under section 213(a) of the Small their discretionary regulatory actions. In three-quarter hour. Business Regulatory Enforcement particular, the Act addresses actions (2) When the security zone is Fairness Act of 1996 (Pub. L. 104–121), that may result in the expenditure by a enforced, the draw is allowed to remain we want to assist small entities in State, local, or tribal government, in the closed to navigation from 2:15 p.m. to understanding this rule. If the rule aggregate, or by the private sector of 5:30 p.m. with the exception of a once would affect your small business, $100,000,000 (adjusted for inflation) or an hour opening at 2:15 p.m., 3:15 p.m., organization, or governmental more in any one year. Though this rule 4:15 p.m. and 5:15 p.m., weekdays only, jurisdiction and you have questions will not result in such an expenditure, if vessels are requesting an opening. At concerning its provisions or options for we do discuss the effects of this rule all other times the draw shall open on compliance, please contact the person elsewhere in this preamble. the quarter and three-quarter hour.

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(v) Royal Park (SR 704) Bridge, mile DATES: This rule is effective from 7:30 Captain of the Port Buffalo (COTP) has 1022.6, at West Palm Beach. (1) The p.m. until 8:30 p.m. on September 21, determined that a fireworks display draw shall open on the hour and half- 2018. presents significant risks to the public hour. ADDRESSES: To view documents safety and property. Such hazards (2) When the security zone is mentioned in this preamble as being include premature and accidental enforced, the draw is allowed to remain available in the docket, go to http:// detonations, dangerous projectiles, and closed to navigation from 2:15 p.m. to www.regulations.gov, type USCG–2018– falling or burning debris. This rule is 5:30 p.m. with the exception of a once 0860 in the ‘‘SEARCH’’ box and click needed to protect personnel, vessels, an hour opening at 2:30 p.m., 3:30 p.m., ‘‘SEARCH.’’ Click on Open Docket and the marine environment in the 4:30 p.m. and 5:30 p.m., weekdays only, Folder on the line associated with this navigable waters within the safety zone if vessels are requesting an opening. At rule. while the fireworks display takes place. all other times the draw shall open on FOR FURTHER INFORMATION CONTACT: If IV. Discussion of the Rule the hour and half-hour. you have questions on this rule, call or (w) Southern Boulevard (SR 700/80) email LTJG Sean Dolan, Chief This rule establishes a temporary Bridge, mile 1024.7, at West Palm Waterways Management Division, U.S. safety zone on September 21, 2018, from Beach. (1) The draw shall open on the Coast Guard; telephone 716–843–9322, 7:30 p.m. until 8:30 p.m. The safety quarter and three-quarter hour. email D09-SMB-SECBuffalo-WWM@ zone will encompass all waters of Lake (2) When the security zone is Ontario, Oswego, NY contained within uscg.mil. ° ′ ″ enforced, the draw may be closed a 280-foot radius of: 43 30 43.30 N, SUPPLEMENTARY INFORMATION: ° ′ ″ without advance notice to permit 76 26 2.70 W. uninterrupted transit of dignitaries I. Table of Abbreviations Entry into, transiting, or anchoring across the bridge. At all other times the within the safety zone is prohibited CFR Code of Federal Regulations unless authorized by the Captain of the bridge shall open on the quarter and DHS Department of Homeland Security three-quarter hour, or as directed by the FR Federal Register Port Buffalo or his designated on-scene on-scene designated representative. NPRM Notice of proposed rulemaking representative. The Captain of the Port or his designated on-scene * * * * * § Section U.S.C. United States Code representative may be contacted via Dated: August 31, 2018. VHF Channel 16. II. Background Information and James A. Passarelli, Regulatory History V. Regulatory Analyses Captain, U.S. Coast Guard Commander, Seventh Coast Guard District, Acting. The Coast Guard is issuing this We developed this rule after [FR Doc. 2018–20500 Filed 9–19–18; 8:45 am] temporary rule without prior notice and considering numerous statutes and BILLING CODE 9110–04–P opportunity to comment pursuant to Executive orders related to rulemaking. authority under section 4(a) of the Below we summarize our analyses Administrative Procedure Act (APA) (5 based on a number of these statutes and DEPARTMENT OF HOMELAND U.S.C. 553(b)). This provision Executive orders, and we discuss First SECURITY authorizes an agency to issue a rule Amendment rights of protestors. without prior notice and opportunity to A. Regulatory Planning and Review Coast Guard comment when the agency for good cause finds that those procedures are Executive Orders 12866 and 13563 33 CFR Part 165 ‘‘impracticable, unnecessary, or contrary direct agencies to assess the costs and to the public interest.’’ Under 5 U.S.C. benefits of available regulatory [Docket Number USCG–2018–0860] 553 (b)(B), the Coast Guard finds that alternatives and, if regulation is good cause exists for not publishing a necessary, to select regulatory approaches that maximize net benefits. RIN 1625–AA00 notice of proposed rulemaking (NPRM) with respect to this rule because the Executive Order 13771 directs agencies Safety Zone; C&S Worldwide Holdings event sponsor did not submit notice to to control regulatory costs through a Inc. Fireworks, Lake Ontario, Oswego, the Coast Guard with sufficient time budgeting process. This rule has not NY remaining before the event to publish an been designated a ‘‘significant NPRM. Delaying the effective date regulatory action,’’ under Executive AGENCY: Coast Guard, DHS. would be contrary to the rule’s Order 12866. Accordingly, this rule has ACTION: Temporary final rule. objectives of enhancing safety of life on not been reviewed by the Office of the navigable water and protection of Management and Budget (OMB), and SUMMARY: The Coast Guard is persons and vessels in vicinity of the pursuant to OMB guidance it is exempt establishing a temporary safety zone for fireworks display. from the requirements of Executive navigable waters within a 280-foot Under 5 U.S.C. 553(d)(3), the Coast Order 13771. radius of the launch site located at 104 Guard finds that good cause exists for This regulatory action determination Bayshore Rd., Oswego, NY. This safety making this rule effective less than 30 is based on the conclusion that this rule zone is intended to restrict vessels form days after publication in the Federal is not a significant regulatory action. We portions of Lake Ontario during the C&S Register. Delaying the effective date anticipate that it will have minimal Worldwide Holdings Inc. fireworks would be contrary to the rule’s impact on the economy, will not display. This temporary safety zone is objectives of enhancing safety of life on interfere with other agencies, will not necessary to protect mariners and the navigable waters and protection of adversely alter the budget of any grant vessels from the navigational hazards persons and vessels in vicinity of the or loan recipients, and will not raise any associated with a fireworks display. fireworks display. novel legal or policy issues. The safety Entry of vessels or persons into this zone created by this rule will be zone is prohibited unless specifically III. Legal Authority and Need for Rule relatively small and enforced for a authorized by the Captain of the Port The Coast Guard is issuing this rule relatively short time. Also, the safety Buffalo. under authority in 33 U.S.C 1231. The zone has been designed to allow vessels

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to transit around it. Thus, restrictions on D. Federalism and Indian Tribal available in the docket where indicated vessel movement within that particular Governments under ADDRESSES. area are expected to be minimal. Under G. Protest Activities certain conditions, moreover, vessels A rule has implications for federalism may still transit through the safety zone under Executive Order 13132, The Coast Guard respects the First when permitted by the Captain of the Federalism, if it has a substantial direct Amendment rights of protesters. Port. effect on the States, on the relationship Protesters are asked to contact the between the national government and person listed in the FOR FURTHER B. Impact on Small Entities the States, or on the distribution of INFORMATION CONTACT section to power and responsibilities among the The Regulatory Flexibility Act of coordinate protest activities so that your various levels of government. We have 1980, 5 U.S.C. 601–612, as amended, message can be received without analyzed this rule under that Order and requires Federal agencies to consider jeopardizing the safety or security of have determined that it is consistent the potential impact of regulations on people, places or vessels. with the fundamental federalism small entities during rulemaking. The principles and preemption requirements List of Subjects in 33 CFR Part 165 term ‘‘small entities’’ comprises small described in Executive Order 13132. Harbors, Marine safety, Navigation businesses, not-for-profit organizations (water), Reporting and recordkeeping that are independently owned and Also, this rule does not have tribal requirements, Security measures, operated and are not dominant in their implications under Executive Order Waterways. fields, and governmental jurisdictions 13175, Consultation and Coordination with populations of less than 50,000. with Indian Tribal Governments, For the reasons discussed in the The Coast Guard certifies under 5 U.S.C. because it does not have a substantial preamble, the Coast Guard amends 33 605(b) that this rule will not have a direct effect on one or more Indian CFR part 165 as follows: significant economic impact on a tribes, on the relationship between the PART 165—REGULATED NAVIGATION substantial number of small entities. Federal Government and Indian tribes, or on the distribution of power and AREAS AND LIMITED ACCESS AREAS While some owners or operators of responsibilities between the Federal ■ 1. The authority citation for part 165 vessels intending to transit the safety Government and Indian tribes. If you continues to read as follows: zone may be small entities, for the believe this rule has implications for reasons stated in section V.A above, this federalism or Indian tribes, please Authority: 33 U.S.C. 1231; 50 U.S.C. 191; rule will not have a significant contact the person listed in the FOR 33 CFR 1.05–1, 6.04–1, 6.04–6, and 160.5; economic impact on any vessel owner FURTHER INFORMATION CONTACT section Department of Homeland Security Delegation or operator. above. No. 0170.1. Under section 213(a) of the Small ■ 2. Add § 165.T09–0860 to read as Business Regulatory Enforcement E. Unfunded Mandates Reform Act follows: Fairness Act of 1996 (Pub. L. 104–121), The Unfunded Mandates Reform Act § 165.T09–0860 Safety Zone; C&S we want to assist small entities in of 1995 (2 U.S.C. 1531–1538) requires understanding this rule. If the rule Worldwide Holdings Inc. fireworks, Lake Federal agencies to assess the effects of Ontario, Oswego, NY. would affect your small business, their discretionary regulatory actions. In organization, or governmental (a) Location. The safety zone will particular, the Act addresses actions encompass all waters of Lake Ontario; jurisdiction and you have questions that may result in the expenditure by a concerning its provisions or options for Oswego, NY contained within a 280-foot State, local, or tribal government, in the radius of: 43°30′43.30″ N, 76°26′2.70″ compliance, please contact the person aggregate, or by the private sector of listed in the FOR FURTHER INFORMATION W. $100,000,000 (adjusted for inflation) or (b) Enforcement period. This CONTACT section. more in any one year. Though this rule regulation will be enforced from 7:30 Small businesses may send comments will not result in such an expenditure, p.m. until 8:30 p.m. on September 21, on the actions of Federal employees we do discuss the effects of this rule 2018. who enforce, or otherwise determine elsewhere in this preamble. (c) Regulations. (1) In accordance with compliance with, Federal regulations to F. Environment the general regulations in § 165.23, entry the Small Business and Agriculture into, transiting, or anchoring within this Regulatory Enforcement Ombudsman We have analyzed this rule under safety zone is prohibited unless and the Regional Small Business Department of Homeland Security authorized by the Captain of the Port Regulatory Fairness Boards. The Directive 023–01 and Commandant Buffalo or his designated on-scene Ombudsman evaluates these actions Instruction M16475.1D, which guide the representative. annually and rates each agency’s Coast Guard in complying with the (2) This safety zone is closed to all responsiveness to small business. If you National Environmental Policy Act of vessel traffic, except as may be wish to comment on actions by 1969 (42 U.S.C. 4321–4370f), and have permitted by the Captain of the Port employees of the Coast Guard, call 1– determined that this action is one of a Buffalo or his designated on-scene 888–REG–FAIR (1–888–734–3247). The category of actions that do not representative. Coast Guard will not retaliate against individually or cumulatively have a (3) The ‘‘on-scene representative’’ of small entities that question or complain significant effect on the human the Captain of the Port Buffalo is any about this rule or any policy or action environment. This rule establishes a Coast Guard commissioned, warrant or of the Coast Guard. temporary safety zone. It is categorically petty officer who has been designated C. Collection of Information excluded from further review under by the Captain of the Port Buffalo to act paragraph L60(a) of Appendix A, Table on his behalf. This rule will not call for a new 1 of DHS Instruction Manual 023–01– (4) Vessel operators desiring to enter collection of information under the 001–01, Rev. 01. A Record of or operate within the safety zone must Paperwork Reduction Act of 1995 (44 Environmental Consideration contact the Captain of the Port Buffalo U.S.C. 3501–3520). supporting this determination is or his on-scene representative to obtain

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permission to do so. The Captain of the or please contact the person identified Submittal); (3) Chapter 6, Permitting Port Buffalo or his on-scene in the FOR FURTHER INFORMATION Requirements, Section 4, Prevention of representative may be contacted via CONTACT section for additional significant deterioration, to remove an VHF Channel 16. Vessel operators given availability information. outdated Federal Register citation permission to enter or operate in the FOR FURTHER INFORMATION CONTACT: under the definition of ‘tpy CO2 safety zone must comply with all Chris Dresser, Air Program, U.S. equivalent emission (CO2e),’ portions of directions given to them by the Captain Environmental Protection Agency which had been approved in a previous of the Port Buffalo, or his on-scene (EPA), Region 8, Mail Code 8P–AR, October 12, 2016 EPA action (2017 representative. 1595 Wynkoop Street, Denver, Colorado Submittal); (4) Chapter 6, Permitting Dated: September 14, 2018. 80202–1129, (303) 312–6385, Requirements, Section 14, Incorporation by reference (2018 Submittal); (5) Joseph S. Dufresne, [email protected]. SUPPLEMENTARY INFORMATION: Chapter 3, General Emission Standards, Captain, U.S. Coast Guard, Captain of the Section 3, Emission standards for Port Buffalo. I. Background Information nitrogen oxides, which corrects an [FR Doc. 2018–20455 Filed 9–19–18; 8:45 am] In a rulemaking published on July 23, inconsistency regarding internal BILLING CODE 9110–04–P 2018 (83 FR 34811), the EPA proposed combustion engines (2017 Submittal); approval of eight revisions to the (6) Chapter 3, General Emission Wyoming Air Quality Standards and Standards, Section 9, Incorporation by ENVIRONMENTAL PROTECTION Regulations submitted by the State of reference (2018 Submittal); (7) Chapter AGENCY Wyoming; four submitted on March 27, 2, Ambient Standards, Section 6, 2017, and four submitted on March 28, Ambient Standards for ozone, to include 40 CFR Part 52 2018. The revisions include updates to the latest ozone NAAQS (2017 [EPA–R08–OAR–2018–0389; FRL–9983– incorporation by reference within Submittal); and (8) Chapter 2, Ambient 50—Region 8] several parts of the Wyoming Air Standards, Section 12, Incorporation by Quality Standards and Regulations that reference (2018 Submittal). Approval and Promulgation of Air are part of the SIP. Additional revisions IV. Incorporation by Reference Quality Implementation Plans; were proposed that: (1) Correct an Wyoming; Incorporation by Reference inconsistency regarding internal In this rule, the EPA is finalizing Updates combustion engine nitrogen oxide regulatory text that includes requirements; (2) amend three state incorporation by reference. In AGENCY: Environmental Protection accordance with requirements of 1 CFR Agency (EPA). regulations to maintain consistency with federal regulations; and (3) update 51.5, the EPA is finalizing the ACTION: Final rule. a state internet address. In this incorporation by reference of Wyoming Air Quality Standards and Regulations SUMMARY: The Environmental Protection rulemaking the EPA is taking final Agency (EPA) is approving eight State action to approve the proposed described in the amendments set forth to 40 CFR part 52, below. The EPA has Implementation Plan (SIP) revisions revisions. The reasons for our approval made, and will continue to make, these submitted by the State of Wyoming; four are provided in the proposed rule. materials generally available through submitted on March 27, 2017, and four II. Response to Public Comments www.regulations.gov and at the EPA submitted on March 28, 2018. The Region 8 office (please contact the revisions include updates to The EPA received three anonymous person identified in the FOR FURTHER incorporation by reference within comments on the proposed SIP INFORMATION CONTACT section of this several parts of the Wyoming Air amendments to the Wyoming Air preamble for more information). Quality Standards and Regulations that Quality Standards and Regulations. Therefore, these materials have been are part of the SIP. Additional revisions After reviewing the comments, the EPA has determined that the comments are approved by the EPA for inclusion in are being approved that: Correct an outside the scope of our proposed action the SIP, have been incorporated by inconsistency regarding internal or fail to identify any material issue reference by the EPA into that plan, are combustion engine nitrogen oxide necessitating a response. All comments fully federally enforceable under requirements; amend three state received on this action are available for sections 110 and 113 of the CAA as of regulations to maintain consistency review in the docket for this the effective date of the final rulemaking with federal regulations; and update a rulemaking. This rule will be finalized of the EPA’s approval, and will be state internet address. as proposed without revisions. incorporated by reference in the next DATES: This final rule is effective on update to the SIP compilation.1 October 22, 2018. III. Final Action ADDRESSES: The EPA has established a For the reasons expressed in the V. Statutory and Executive Orders docket for this action under Docket ID proposed rule, the EPA is approving the Review No. EPA–R08–OAR–2018–0389. All eight SIP submittals to the Wyoming Air Under the CAA, the Administrator is documents in the docket are listed on Quality Standards and Regulations required to approve a SIP submission the http://www.regulations.gov website. submitted by the State of Wyoming on that complies with the provisions of the Although listed in the index, some March 27, 2017, and March 28, 2018. Act and applicable federal regulations information is not publicly available, This action updates: (1) Chapter 8 Non- (42 U.S.C. 7410(k), 40 CFR 52.02(a)). e.g., CBI or other information whose attainment Area Regulations, Section Thus, in reviewing SIP submissions, the disclosure is restricted by statute. 10, Incorporation by reference (2017 EPA’s role is to approve state choices, Certain other material, such as Submittal); (2) Chapter 8, Non- provided that they meet the criteria of copyrighted material, is not placed on attainment Area Regulations, Section 3, the CAA. Accordingly, this final action the internet and will be publicly Conformity of general federal actions to merely approves some state law as available only in hard copy form. state implementation plans (2018 meeting federal requirements; this final Publicly available docket materials are Submittal), and Section 10, available through www.regulations.gov, Incorporation by reference (2018 1 62 FR 27968 (May 22, 1997).

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action does not impose additional health or environmental effects, using be challenged later in proceedings to requirements beyond those imposed by practicable and legally permissible enforce its requirements. (See CAA state law. For that reason, this final methods, under Executive Order 12898 section 307(b)(2).) action: (59 FR 7629, Feb. 16, 1994). • Is not a ‘‘significant regulatory The SIP is not approved to apply on List of Subjects in 40 CFR Part 52 action’’ subject to review by the Office any Indian reservation land or in any Environmental protection, Air of Management and Budget under other area where the EPA or an Indian pollution control, Carbon monoxide, Executive Order 12866 (58 FR 51735, tribe has demonstrated that a tribe has Incorporation by reference, Oct. 4, 1993) and 13563 (76 FR 3821, jurisdiction. In those areas of Indian Intergovernmental relations, Lead, January 21, 2011); country, the rule does not have tribal Nitrogen dioxide, Ozone, Particulate • This action is not an Executive implications and will not impose matter, Reporting and recordkeeping Order 13771 (82 FR 9339, Feb. 2, 2017) substantial direct costs on tribal requirements. regulatory action because actions such governments or preempt tribal law as Dated: September 14, 2018. as approving SIPs are exempted under specified by Executive Order 13175 (65 Executive Order 12866; FR 67249, November 9, 2000). Douglas Benevento, • Does not impose an information The Congressional Review Act, 5 Regional Administrator, Region 8. collection burden under the provisions U.S.C. 801 et seq., as added by the Small 40 CFR part 52 is amended as follows: of the Paperwork Reduction Act (44 Business Regulatory Enforcement U.S.C. 3501 et seq.); Fairness Act of 1996, generally provides PART 52—APPROVAL AND • Is certified as not having a that before a rule may take effect, the PROMULGATION OF significant economic impact on a agency promulgating the rule must IMPLEMENTATION PLANS substantial number of small entities submit a rule report, which includes a under the Regulatory Flexibility Act (5 copy of the rule, to each House of the ■ 1. The authority citation for part 52 U.S.C. 601 et seq.); Congress and to the Comptroller General continues to read as follows: • Does not contain any unfunded of the United States. The EPA will Authority: 42 U.S.C. 7401 et seq. mandate or significantly or uniquely submit a report containing this action affect small governments, as described and other required information to the Subpart ZZ—Wyoming in the Unfunded Mandates Reform Act U.S. Senate, the U.S. House of of 1995 (Pub. L. 104–4); Representatives, and the Comptroller ■ 2. In § 52.2620, the table in paragraph • Does not have federalism General of the United States prior to (c) is amended by revising: implications as specified in Executive publication of the rule in the Federal ■ a. Under the center heading ‘‘Chapter Order 13132 (64 FR 43255, Aug. 10, Register. A major rule cannot take effect 02, Ambient Standards,’’ the table 1999); until 60 days after it is published in the entries for Section 06 and Section 12; • Is not an economically significant Federal Register. This action is not a ■ b. Under the center heading ‘‘Chapter regulatory action based on health or ‘‘major rule’’ as defined by 5 U.S.C. 03, General Emission Standards,’’ the safety risks subject to Executive Order 804(2). table entries for Section 03 and Section 13045 (62 FR 19885, April 23, 1997); Under section 307(b)(1) of the CAA, • Is not a significant regulatory action petitions for judicial review of this 09; subject to Executive Order 13211 (66 FR action must be filed in the United States ■ c. Under the center heading ‘‘Chapter 28355, May 22, 2001); Court of Appeals for the appropriate 06, Permitting Requirements,’’ Section • Is not subject to requirements of circuit by November 19, 2018. Filing a 04 and Section 14; and Section 12(d) of the National petition for reconsideration by the ■ d. Under the center heading ‘‘Chapter Technology Transfer and Advancement Administrator of this final rule does not 08, Non-attainment Area Regulations,’’ Act of 1995 (15 U.S.C. 272 note) because affect the finality of this action for the Section 03 and Section 10. application of those requirements would purposes of judicial review nor does it The revisions read as follows: be inconsistent with the CAA; and extend the time within which a petition • Does not provide the EPA with the for judicial review may be filed, and § 52.2620 Identification of plan. discretionary authority to address, as shall not postpone the effectiveness of * * * * * appropriate, disproportionate human such rule or action. This action may not (c) * * *

State EPA Rule No. Rule title effective effective Final rule citation/date Comments date date

*******

Chapter 02. Ambient Standards

******* Section 06 ...... Ambient Standards for ozone ...... 12/20/2016 10/22/2018 [Insert Federal Register citation]. 9/20/2018.

******* Section 12 ...... Incorporation by reference ...... 2/5/2018 10/22/2018 [Insert Federal Register citation]. 9/20/2018.

Chapter 03. General Emission Standards

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State EPA Rule No. Rule title effective effective Final rule citation/date Comments date date

******* Section 03 ...... Emission standards for nitrogen ox- 12/20/2016 10/22/2018 [Insert Federal Register ides. citation]. 9/20/2018.

******* Section 09 ...... Incorporation by reference ...... 2/5/2018 10/22/2018 [Insert Federal Register citation]. 9/20/2018.

*******

Chapter 06. Permitting Requirements

******* Section 04 ...... Prevention of significant deterioration 12/20/2016 10/22/2018 [Insert Federal Register citation]. September 20, 2018.

******* Section 14 ...... Incorporation by reference ...... 2/5/2018 10/22/2018 [Insert Federal Register citation]. September 20, 2018.

*******

Chapter 08. Non-attainment Area Regulations

******* Section 03 ...... Conformity of general federal actions 2/5/2018 10/22/2018 [Insert Federal Register to state implementation plans. citation]. September 20, 2018.

******* Section 10 ...... Incorporation by reference ...... 2/5/2018 10/22/2018 [Insert Federal Register citation]. September 20, 2018.

*******

* * * * * infrastructure monitoring requirements available through http:// [FR Doc. 2018–20447 Filed 9–19–18; 8:45 am] of the Clean Air Act (Act or CAA) for www.regulations.gov, or please contact BILLING CODE 6560–50–P the National Ambient Air Quality the person identified in the FOR FURTHER Standards (NAAQS) promulgated for INFORMATION CONTACT section for lead (Pb) on October 15, 2008, nitrogen additional availability information. ENVIRONMENTAL PROTECTION dioxide (NO2) on January 22, 2010, FOR FURTHER INFORMATION CONTACT: Kate AGENCY sulfur dioxide (SO2) on June 2, 2010, Gregory, Air Program, U.S. and fine particulate matter (PM ) on 40 CFR Part 52 2.5 Environmental Protection Agency December 14, 2012. The EPA is taking (EPA), Region 8, Mail Code 8P–AR, [EPA–R08–OAR–2018–0388–0001; FRL– this action pursuant to section 110 of 1595 Wynkoop Street, Denver, Colorado 9983–73—Region 8] the Clean Air Act (CAA). 80202–1129, (303) 312–6175, DATES: This rule is effective on October [email protected]. Air Quality State Implementation 22, 2018. Plans; Approvals and Promulgations: SUPPLEMENTARY INFORMATION: ADDRESSES: Infrastructure Monitoring The EPA has established a Throughout this document ‘‘we,’’ ‘‘us,’’ Requirements for the 2008 Pb, 2010 docket for this action under Docket ID and ‘‘our’’ means the EPA. No. EPA–R08–OAR–2018–0388–0001. SO2, 2010 NO2 and 2012 PM2.5 National I. Background Ambient Air Quality Standards; Utah All documents in the docket are listed on the http://www.regulations.gov The background for this action is AGENCY: Environmental Protection website. Although listed in the index, discussed in detail in our July 23, 2018 Agency (EPA). some information is not publicly proposal (83 FR 34816). In that ACTION: Final rule. available, e.g., CBI or other information document we proposed to approve the whose disclosure is restricted by statute. State’s submittal in reference to SUMMARY: The Environmental Protection Certain other material, such as infrastructure requirements for CAA Agency (EPA) is approving elements of copyrighted material, is not placed on section 110(a)(2)(B), element B: Ambient State Implementation Plan (SIP) the internet and will be publicly air quality monitoring/data system. In revisions from the State of Utah to available only in hard copy form. the proposal, we find that Utah’s SIP demonstrate the State meets Publicly available docket materials are and practices are adequate for the

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ambient air quality monitoring and data • Is not an Executive Order 13771 (82 publication of the rule in the Federal system requirements and therefore FR 9339, February 2, 2017) regulatory Register. A major rule cannot take effect propose to approve the infrastructure action because SIP approvals are until 60 days after it is published in the SIP for the 2008 Pb, 2010 SO2, 2010 NO2 exempted under Executive Order 12866; Federal Register. This action is not a and 2012 PM2.5 NAAQS for this • Does not impose an information ‘‘major rule’’ as defined by 5 U.S.C. element. collection burden under the provisions 804(2). of the Paperwork Reduction Act (44 Under section 307(b)(1) of the Clean II. Response to Comments U.S.C. 3501 et seq.); Air Act, petitions for judicial review of The EPA received six anonymous • Is certified as not having a this action must be filed in the United comments on the proposal. After significant economic impact on a States Court of Appeals for the reviewing the comments, the EPA has substantial number of small entities appropriate circuit by November 19, determined that the comments are under the Regulatory Flexibility Act (5 2018. Filing a petition for outside the scope of our proposed action U.S.C. 601 et seq.); reconsideration by the Administrator of or fail to identify any material issue • Does not contain any unfunded this final rule does not affect the finality necessitating a response. All comments mandate or significantly or uniquely of this action for the purposes of judicial received on this action are available for affect small governments, described in review nor does it extend the time review in the docket for this the Unfunded Mandates Reform Act of within which a petition for judicial rulemaking. This rule will be finalized 1995 (Pub. L. 104–4); review may be filed, and shall not as proposed without revisions. • Does not have federalism postpone the effectiveness of such rule implications as specified in Executive or action. This action may not be III. Final Action Order 13132 (64 FR 43255, August 10, challenged later in proceedings to We are approving infrastructure 1999); enforce its requirements. (See section element B for the 2008 Pb, 2010 SO2, • Is not an economically significant 307(b)(2).) 2010 NO2 and 2012 PM2.5 NAAQS from regulatory action based on health or List of Subjects in 40 CFR Part 52 the State’s certifications as shown in safety risks subject to Executive Order Table 1. 13045 (62 FR 19885, April 23, 1997); Environmental protection, Air • Is not a significant regulatory action pollution control, Carbon monoxide, TABLE 1—LIST OF UTAH INFRASTRUC- subject to Executive Order 13211 (66 FR Incorporation by reference, Intergovernmental relations, TURE ELEMENTS THAT THE EPA IS 28355, May 22, 2001); Greenhouse gases, Lead, Nitrogen APPROVING • Is not subject to requirements of section 12(d) of the National dioxide, Ozone, Particulate matter, Reporting and recordkeeping Approval Element Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272 note) because requirements, Sulfur oxides, Volatile January 19, 2012 submittal—2008 application of those requirements would organic compounds. Pb NAAQS ...... (B) be inconsistent with the CAA; and Dated: September 14, 2018. January 31, 2013 submittal—2010 • Does not provide the EPA with the Douglas Benevento, NO NAAQS ...... (B) 2 discretionary authority to address, as Regional Administrator, Region 8. June 2, 2013 submittal—2010 SO2 NAAQS ...... (B) appropriate, disproportionate human 40 CFR part 52 is amended to follows: December 4, 2015 submittal—2012 health or environmental effects, using PM2.5 NAAQS ...... (B) practicable and legally permissible PART 52—APPROVAL AND methods, under Executive Order 12898 PROMULGATION OF For the basis of our approval, please (59 FR 7629, February 16, 1994). IMPLEMENTATION PLANS refer to the July 23, 2018 proposal (83 In addition, the SIP is not approved to ■ FR 34816). apply on any Indian reservation land or 1. The authority citation for part 52 continues to read as follows: IV. Statutory and Executive Order in any other area where EPA or an Authority: 42 U.S.C. 7401 et seq. Reviews Indian tribe has demonstrated that a tribe has jurisdiction. In those areas of Under the Clean Air Act, the Indian country, the rule does not have Subpart TT—Utah Administrator is required to approve a tribal implications and will not impose ■ 2. Section 52.2355 is amended by SIP submission that complies with the substantial direct costs on tribal adding paragraph (d) to read as follows: provisions of the Act and applicable governments or preempt tribal law as federal regulations. 42 U.S.C. 7410(k); specified by Executive Order 13175 (65 § 52.2355 Section 110(a)(2) infrastructure 40 CFR 52.02(a). Thus, in reviewing SIP FR 67249, November 9, 2000). requirements. submissions, the EPA’s role is to The Congressional Review Act, 5 * * * * * approve state choices, provided that U.S.C. 801 et seq., as added by the Small (d) The Utah Department of they meet the criteria of the Clean Air Business Regulatory Enforcement Environmental Quality submitted Act. Accordingly, this action merely Fairness Act of 1996, generally provides certification of Utah’s infrastructure SIP approves state law as meeting federal that before a rule may take effect, the for the 2008 Pb NAAQS on January 19, requirements and does not impose agency promulgating the rule must 2012; 2010 NO2 NAAQS on January 31, additional requirements beyond those submit a rule report, which includes a 2013; 2010 SO2 NAAQS on June 2, imposed by state law. For that reason, copy of the rule, to each House of the 2013; and 2012 PM2.5 on December 4, this action: Congress and to the Comptroller General 2015. Utah’s infrastructure certifications • Is not a ‘‘significant regulatory of the United States. The EPA will demonstrate how the State, where action’’ subject to review by the Office submit a report containing this action applicable, has plans in place that meet of Management and Budget under and other required information to the the requirements of section 110 for the Executive Orders 12866 (58 FR 51735, U.S. Senate, the U.S. House of 2008 Pb, 2010 NO2, 2010 SO2 and 2012 October 4, 1993) and 13563 (76 FR 3821, Representatives, and the Comptroller PM2.5 NAAQS. The State’s January 21, 2011); General of the United States prior to Infrastructure SIP for 2008 Pb, 2010

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NO2, 2010 SO2 and 2012 PM2.5 NAAQS I. Background Information of the Paperwork Reduction Act (44 is approved with respect to 110(a)(2)(B). U.S.C. 3501 et seq.); On July 23, 2018, the EPA proposed • [FR Doc. 2018–20448 Filed 9–19–18; 8:45 am] to approve Washington as meeting the is certified as not having a significant economic impact on a BILLING CODE 6560–50–P requirement that each SIP contain adequate provisions to prohibit substantial number of small entities emissions that will contribute under the Regulatory Flexibility Act (5 ENVIRONMENTAL PROTECTION U.S.C. 601 et seq.); significantly to nonattainment or • AGENCY interfere with maintenance of the 2015 does not contain any unfunded ozone NAAQS in any other state (83 FR mandate or significantly or uniquely 40 CFR Part 52 34813). An explanation of the Clean Air affect small governments, as described Act requirements, a detailed analysis of in the Unfunded Mandates Reform Act [EPA–R10–OAR–2018–0061; FRL–9983– the submittal, and the EPA’s reasons for of 1995 (Pub. L. 104–4); 83—Region 10] • does not have Federalism proposing approval were provided in the notice of proposed rulemaking, and implications as specified in Executive Air Plan Approval; Washington; Order 13132 (64 FR 43255, August 10, Interstate Transport Requirements for will not be restated here. The public comment period for the proposal ended 1999); the 2015 Ozone NAAQS • is not an economically significant August 22, 2018. AGENCY: Environmental Protection regulatory action based on health or Agency (EPA). II. Response to Comments safety risks subject to Executive Order 13045 (62 FR 19885, April 23, 1997); ACTION: Final rule. We received several anonymous • comments unrelated to Washington’s is not a significant regulatory action SUMMARY: The Clean Air Act (CAA) submission. After reviewing the subject to Executive Order 13211 (66 FR requires each State Implementation Plan anonymous comments, we have 28355, May 22, 2001); • is not subject to requirements of (SIP) to contain adequate provisions determined that the comments are Section 12(d) of the National prohibiting emissions that will have outside the scope of our proposed action Technology Transfer and Advancement certain adverse air quality effects in and fail to identify any material issue Act of 1995 (15 U.S.C. 272 note) because other states. On February 7, 2018, the necessitating a response. For more this action does not involve technical State of Washington made a submittal to information, please see our standards; and the Environmental Protection Agency memorandum included in the docket for • this action. does not provide the EPA with the (EPA) to address these requirements for discretionary authority to address, as the 2015 ozone National Ambient Air III. Final Action appropriate, disproportionate human Quality Standards (NAAQS). The EPA is health or environmental effects, using approving the submittal as meeting the The EPA is approving Washington’s February 7, 2018, submittal certifying practicable and legally permissible requirement that each SIP contain methods, under Executive Order 12898 adequate provisions to prohibit that the SIP is sufficient to meet the interstate transport requirements of (59 FR 7629, February 16, 1994). emissions that will significantly The SIP is not approved to apply on contribute to nonattainment or interfere Clean Air Act section 110(a)(2)(D)(i)(I) for the 2015 ozone NAAQS. any Indian reservation land and is also with maintenance of the 2015 ozone not approved to apply in any other area NAAQS in any other state. IV. Statutory and Executive Order where the EPA or an Indian tribe has DATES: This final rule is effective Reviews demonstrated that a tribe has October 22, 2018. Under the Clean Air Act, the jurisdiction. In those areas of Indian ADDRESSES: The EPA has established a Administrator is required to approve a country, the rule does not have tribal docket for this action under Docket ID SIP submission that complies with the implications as specified by Executive No. EPA–R10–OAR–2018–0061. All provisions of the Clean Air Act and Order 13175 (65 FR 67249, November 9, documents in the docket are listed on applicable federal regulations. 42 U.S.C. 2000). the https://www.regulations.gov 7410(k); 40 CFR 52.02(a). Thus, in The Congressional Review Act, 5 website. Although listed in the index, reviewing SIP submissions, the EPA’s U.S.C. 801 et seq., as added by the Small some information is not publicly role is to approve state choices, Business Regulatory Enforcement available, e.g., CBI or other information provided that they meet the criteria of Fairness Act of 1996, generally provides the disclosure of which is restricted by the Clean Air Act. Accordingly, this that before a rule may take effect, the statute. Certain other material, such as action merely approves state law as agency promulgating the rule must copyrighted material, is not placed on meeting federal requirements and does submit a rule report, which includes a the internet and is publicly available not impose additional requirements copy of the rule, to each House of the only in hard copy form. Publicly beyond those imposed by state law. For Congress and to the Comptroller General available docket materials are available that reason, this action: of the United States. The EPA will at https://www.regulations.gov, or • Is not a ‘‘significant regulatory submit a report containing this action please contact the person identified in action’’ subject to review by the Office and other required information to the the FOR FURTHER INFORMATION CONTACT of Management and Budget under U.S. Senate, the U.S. House of section for additional availability Executive Orders 12866 (58 FR 51735, Representatives, and the Comptroller information. October 4, 1993) and 13563 (76 FR 3821, General of the United States prior to January 21, 2011); publication of the rule in the Federal FOR FURTHER INFORMATION CONTACT: Jeff • is not an Executive Order 13771 (82 Register. A major rule cannot take effect Hunt at (206) 553–0256, or hunt.jeff@ FR 9339, February 2, 2017) regulatory until 60 days after it is published in the epa.gov. action because actions such as SIP Federal Register. This action is not a SUPPLEMENTARY INFORMATION: approvals are exempted under ‘‘major rule’’ as defined by 5 U.S.C. Throughout this document wherever Executive Order 12866; 804(2). ‘‘we,’’ ‘‘us,’’ or ‘‘our’’ is used, it is • does not impose an information Under section 307(b)(1) of the Clean intended to refer to the EPA. collection burden under the provisions Air Act, petitions for judicial review of

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this action must be filed in the United Intergovernmental relations, Lead, Authority: 42 U.S.C. 7401 et seq. States Court of Appeals for the Nitrogen dioxide, Ozone, Particulate appropriate circuit by November 19, matter, Reporting and recordkeeping Subpart WW—Washington 2018. Filing a petition for requirements, Sulfur oxides, Volatile reconsideration by the Administrator of organic compounds. ■ 2. In § 52.2470, table 2 in paragraph this final rule does not affect the finality Authority: 42 U.S.C. 7401 et seq. (e) is amended by adding the entry for of this action for the purposes of judicial ‘‘Interstate Transport for the 2015 Ozone review nor does it extend the time Dated: September 5, 2018. NAAQS’’ immediately below the entry within which a petition for judicial Chris Hladick, for ‘‘Interstate Transport for the 2012 Regional Administrator, Region 10. review may be filed, and shall not PM2.5 NAAQS’’ to read as follows: postpone the effectiveness of such rule For the reasons set forth in the or action. This action may not be preamble, 40 CFR part 52 is amended as § 52.2470 Identification of plan. challenged later in proceedings to follows: * * * * * enforce its requirements (See section (e) * * * 307(b)(2)). PART 52—APPROVAL AND PROMULGATION OF List of Subjects in 40 CFR Part 52 IMPLEMENTATION PLANS Environmental protection, Air pollution control, Carbon monoxide, ■ 1. The authority citation for part 52 Incorporation by reference, continues to read as follows:

TABLE 2—ATTAINMENT, MAINTENANCE, AND OTHER PLANS

Applicable geographic or State Name of SIP provision nonattainment submittal date EPA approval date Explanations area

******* Interstate Transport for the 2015 Statewide ...... 2/7/2018 9/20/2018, [Insert Federal Reg- This action addresses CAA Ozone NAAQS. ister citation]. 110(a)(2)(D)(i)(I).

*******

[FR Doc. 2018–20389 Filed 9–19–18; 8:45 am] Arkansas sources do not contribute SUPPLEMENTARY INFORMATION: BILLING CODE 6560–50–P significantly to nonattainment in, or Throughout this document ‘‘we,’’ ‘‘us,’’ interfere with maintenance by, any and ‘‘our’’ means the EPA. We selected other state with regard to the 2012 PM2.5 a November 7, 2018 effective date for ENVIRONMENTAL PROTECTION NAAQS. The EPA is also approving a this final rule in order for the CFR to AGENCY revision to update incorporation by reflect this approval and our August 8, reference of NAAQS germane to the 40 CFR Part 52 2018 approval of Arkansas Regulation Arkansas SIP. 19 Chapter 2 (83 FR 38964) which has [EPA–R06–OAR–2017–0435; FRL–9983– an effective date of November 6, 2018. 35—Region 6] DATES: This final rule is effective on November 7, 2018. I. Background Approval and Promulgation of ADDRESSES: The EPA has established a Implementation Plans; Arkansas; The background for this action is docket for this action under Docket ID Interstate Transport Requirements for discussed in detail in our June 26, 2018 No EPA–R06–OAR–2017–0435. All the 2012 PM NAAQS and Definition proposal (83 FR 30622). In that 2.5 documents in the docket are listed on Update document we proposed to approve the http://www.regulations.gov website. portions of Arkansas’ State AGENCY: Environmental Protection Although listed in the index, some Agency (EPA). information is not publicly available, Implementation Plan (SIP) March 24, 2017 submittal, that addresses a CAA ACTION: Final rule. e.g., Confidential Business Information or other information whose disclosure is requirement that SIPs account for SUMMARY: Pursuant to the Federal Clean restricted by statute. Certain other potential interstate transport of air Air Act (CAA or the Act), the material, such as copyrighted material, pollution that significantly contributes Environmental Protection Agency (EPA) is not placed on the internet and will be to nonattainment or interferes with is approving portions of the Arkansas publicly available only in hard copy maintenance of the 2012 PM2.5 NAAQS State Implementation Plan (SIP) form. Publicly available docket in other states. We proposed to submittal addressing the CAA materials are available either determine that emissions from Arkansas requirement that SIPs address the electronically through http:// sources do not contribute significantly potential for interstate transport of air www.regulations.gov or in hard copy at to nonattainment in, or interfere with pollution to significantly contribute to the EPA Region 6, 1445 Ross Avenue, maintenance by, any other state with nonattainment or interfere with Suite 700, Dallas, Texas 75202–2733. regard to the 2012 PM2.5 NAAQS. We maintenance of the 2012 fine particulate also proposed to approve updates to that matter (PM2.5) National Ambient Air FOR FURTHER INFORMATION CONTACT: Quality Standard (NAAQS) in other Sherry Fuerst, 214–665–6454, states. EPA finds that emissions from [email protected].

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definition of NAAQS and the NAAQS 51.5, the EPA is finalizing the safety risks subject to Executive Order list.1 incorporation by reference of the 13045 (62 FR 19885, April 23, 1997); We received four anonymous public revisions to the Arkansas regulations as • Is not a significant regulatory action comments on the proposed rulemaking described in the Final Action section subject to Executive Order 13211 (66 FR action. The comments are posted to the above. The EPA has made, and will 28355, May 22, 2001); docket (EPA–R06–OAR–2017–0435). In continue to make, these materials • the first comment, received on July 31, generally available through Is not subject to requirements of 2018, the commenter discusses the costs www.regulations.gov and at the EPA section 12(d) of the National of renewable energy in Europe and in Region 6 Office (please contact Sherry Technology Transfer and Advancement the northeast United States. Such Fuerst, 214–665–6454, fuerst.sherry@ Act of 1995 (15 U.S.C. 272 note) because comment is irrelevant and is outside the epa.gov for more information). application of those requirements would scope of this specific rule making Therefore, these materials have been be inconsistent with the CAA; and action. In the second comment, received approved by EPA for inclusion in the • Does not provide EPA with the July 31, 2018 the commenter discusses SIP, have been incorporated by discretionary authority to address, as the use of child labor in rare earth reference by EPA into that plan, are appropriate, disproportionate human mining, and the dangers associated with fully federally enforceable under health or environmental effects, using this type of mining. Such comment is sections 110 and 113 of the CAA as of practicable and legally permissible irrelevant and outside the scope of this the effective date of the final rulemaking methods, under Executive Order 12898 specific rule making action. In the third of EPA’s approval, and will be (59 FR 7629, February 16, 1994). incorporated by reference in the next comment, received July 31, 2018 the In addition, the SIP is not approved commenter discusses the CO2 emissions update to the SIP compilation. to apply on any Indian reservation land produced by forest fires. Such comment V. Statutory and Executive Order or in any other area where EPA or an is irrelevant and outside the scope of Reviews Indian tribe has demonstrated that a this specific rule making action. In the tribe has jurisdiction. In those areas of fourth comment, received on July 31, Under the Clean Air Act, the Indian country, the rule does not have 2018, the commenter provided personal Administrator is required to approve a tribal implications and will not impose observations regarding the SIP submission that complies with the substantial direct costs on tribal Administration. Such comments are provisions of the Act and applicable governments or preempt tribal law as irrelevant and outside the scope of this Federal regulations. 42 U.S.C. 7410(k); specified by Executive Order 13175 (65 specific rule making action. Since these 40 CFR 52.02(a). Thus, in reviewing SIP FR 67249, November 9, 2000). comments are not relevant to the submissions, the EPA’s role is to specific action EPA proposed, the EPA approve state choices, provided that The Congressional Review Act, 5 will not be responding to these they meet the criteria of the Clean Air U.S.C. 801 et seq., as added by the Small comments or making any changes to our Act. Accordingly, this action merely Business Regulatory Enforcement proposed rulemaking. approves state law as meeting Federal Fairness Act of 1996, generally provides requirements and does not impose that before a rule may take effect, the II. Final Action additional requirements beyond those agency promulgating the rule must Pursuant to section 110 of the CAA imposed by state law. For that reason, submit a rule report, which includes a we are approving the following this action: copy of the rule, to each House of the revisions to the Arkansas SIP submitted • Is not a ‘‘significant regulatory Congress and to the Comptroller General on March 24, 2017: action’’ subject to review by the Office of the United States. EPA will submit a • The portion of the Arkansas SIP of Management and Budget under report containing this action and other submittal, pertaining to interstate Executive Orders 12866 (58 FR 51735, required information to the U.S. Senate, transport of air pollution, that October 4, 1993) and 13563 (76 FR 3821, the U.S. House of Representatives, and establishes emissions from Arkansas January 21, 2011); the Comptroller General of the United • will not significantly contribute to Is not an Executive Order 13771 (82 States prior to publication of the rule in nonattainment or interfere with FR 9339, February 2, 2017) regulatory the Federal Register. A major rule maintenance of the 2012 PM2.5 NAAQS action because SIP approvals are cannot take effect until 60 days after it in any other state. exempted under Executive Order 12866; • is published in the Federal Register. • The portion of the Arkansas SIP Does not impose an information This action is not a ‘‘major rule’’ as submittal that revised the definition of collection burden under the provisions defined by 5 U.S.C. 804(2). of the Paperwork Reduction Act (44 NAAQS in Regulation 19, Chapter 2 and Under section 307(b)(1) of the Clean revised the entry for ‘‘Particle Pollution, U.S.C. 3501 et seq.); • Is certified as not having a Air Act, petitions for judicial review of PM2.5’’ in Regulation 19, Appendix B. this action must be filed in the United We find that emissions from Arkansas significant economic impact on a substantial number of small entities States Court of Appeals for the sources do not contribute significantly appropriate circuit by November 19, to nonattainment in, or interfere with under the Regulatory Flexibility Act (5 U.S.C. 601 et seq.); 2018. Filing a petition for maintenance by, any other state with • reconsideration by the Administrator of regard to the 2012 PM NAAQS. Does not contain any unfunded 2.5 mandate or significantly or uniquely this final rule does not affect the finality III. Incorporation by Reference affect small governments, described in of this action for the purposes of judicial review nor does it extend the time In this rule, the EPA is finalizing the Unfunded Mandates Reform Act of within which a petition for judicial regulatory text that includes 1995 (Pub. L. 104–4); • review may be filed, and shall not incorporation by reference. In Does not have Federalism postpone the effectiveness of such rule accordance with requirements of 1 CFR implications as specified in Executive Order 13132 (64 FR 43255, August 10, or action. This action may not be 1999); challenged later in proceedings to 1 In a separate action we approved other revisions • to definitions in the Arkansas SIP (83 FR 38964, Is not an economically significant enforce its requirements. (See section August 8, 2018). regulatory action based on health or 307(b)(2).)

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List of Subjects in 40 CFR Part 52 PART 52—APPROVAL AND the entries under Regulation 19 for PROMULGATION OF Chapter 2 and Appendix B; and Environmental protection, Air IMPLEMENTATION PLANS ■ b. I paragraph (e), the second table pollution control, Incorporation by titled ‘‘EPA-Approved Non-Regulatory reference, Particulate matter. ■ 1. The authority citation for part 52 Provisions and Quasi-Regulatory Dated: September 13, 2018. continues to read as follows: Measures in the Arkansas SIP’’ is Anne Idsal, Authority: 42 U.S.C. 7401 et seq. amended by revising the entry for ‘‘Infrastructure for the 2012 PM2.5 Regional Administrator, Region 6. Subpart E—Arkansas NAAQS’’. Therefore, 40 CFR part 52 is amended The revisions read as follows: ■ 2. In § 52.170: as follows: ■ a. In paragraph (c), the table titled § 52.170 Identification of plan. ‘‘EPA-Approved Regulations in the * * * * * Arkansas SIP’’ is amended by revising (c) * * *

EPA-APPROVED REGULATIONS IN THE ARKANSAS SIP

State State citation Title/subject submittal/ EPA approval date Explanation effective date

Regulation No. 19: Regulations of the Arkansas Plan of Implementation for Air Pollution Control

*******

Chapter 2: Definitions

Chapter 2 ...... Definitions ...... 3/24/2017 8/8/2018, 83 FR 38964 .... The definition of VOC was approved on 12/21/2017 (82 FR 60517). The defi- nition of National Ambient Air Quality Standards was approved on 9/20/ 2018, [Insert Federal Register cita- tion].

*******

Appendix B: National Ambient Air Quality Standards List

Appendix B ...... National Ambient Air Qual- 3/24/2017 8/8/2018, 83 FR 38964 .... The revision to Particle Pollution, PM2.5 ity Standards List. was approved on 9/20/2018, [Insert Federal Register citation].

*******

(e) * * *

EPA-APPROVED NONREGULATORY PROVISIONS AND QUASI-REGULATORY MEASURES IN THE ARKANSAS SIP

State Name of SIP provision Applicable geographic or submittal/ EPA approval date Explanation nonattainment area effective date

******* Infrastructure for the 2012 Statewide ...... 3/24/2017 2/14/2018, 83 FR 6470.... Approval for 110(a)(2)(A), (B), (C), PM2.5 NAAQS. (D)(i) (portion pertaining to PSD), (D)(ii), (E), (F), (G), (H), (J), (K), (L) and (M). Approval for 110(a)(2)(D)(i)(I) (signifi- cant contribution to nonattainment or interfere with maintenance in any other state) on 9/20/2018, [Insert Federal Register citation].

[FR Doc. 2018–20480 Filed 9–19–18; 8:45 am] BILLING CODE 6560–50–P

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ENVIRONMENTAL PROTECTION Boulevard, Lenexa, Kansas 66219 at plan submission in accordance with 40 AGENCY (913) 551–7214, or by email at CFR 51.102. The submission also [email protected]. satisfied the completeness criteria of 40 40 CFR Parts 52 and 81 SUPPLEMENTARY INFORMATION: CFR part 51, appendix V. The state held [EPA–R07–OAR–2017–0349; FRL–9983– Throughout this document ‘‘we,’’ ‘‘us,’’ a public comment period from June 27, 68—Region 7] and ‘‘our’’ refer to EPA. This section 2016, to August 4, 2016, and received provides additional information by six comments from three commenters. A Approval of Missouri Air Quality addressing the following: public hearing was held on July 28, Implementation Plans; Redesignation 2016. Table of Contents of the Missouri Portion of the St. III. EPA’s Response to Comments Louis-St. Charles-Farmington, MO-IL I. What is being addressed in this document? 2008 Ozone Area to Attainment II. Have the requirements for approval of a EPA provided a thirty-day review and SIP revision been met? comment period for the June 25, 2018 AGENCY: Environmental Protection III. EPA’s Response to Comments proposed rule. The comment period Agency (EPA). IV. What action is EPA taking? ended on July 25, 2018. EPA received ACTION: Final rule. V. Statutory and Executive Order Reviews three sets of comments, specifically I. What is being addressed in this adverse comments from the Missouri SUMMARY: The Environmental Protection document? Department of Natural Resources Agency (EPA) is taking final action to (MDNR) and the Sierra Club. Full sets redesignate the Missouri portion of the This final rulemaking takes final of these comments are provided in the St. Louis-St. Charles-Farmington, MO-IL action on submissions from MDNR docket for this final action. A summary nonattainment area (‘‘St. Louis area’’ or dated September 12, 2016, and of the adverse comments and EPA’s ‘‘area’’) to attainment for the 2008 ozone supplemented on February 16, 2018, responses are provided below. National Ambient Air Quality Standard requesting redesignation of the Missouri Comment: The commenter stated that (NAAQS). EPA is also approving, as a portion of the St. Louis area attainment Missouri’s most recent monitoring revision to the Missouri State for the 2008 ozone NAAQS. The network plan was approved in 2017, as Implementation Plan (SIP), the state’s background for this action is discussed also stated in the proposal. However, a plan for maintaining the 2008 8-hour in detail in EPA’s proposed rulemaking footnote in the proposal references the ozone NAAQS through 2030. Finally, published in the Federal Register on 2016 monitoring network plan and the EPA finds adequate and is approving, as June 25, 2018 (83 FR 29486). In that state’s commitment to verified a SIP revision, the State’s 2030 volatile proposed rulemaking we noted, under attainment. The commenter is organic compound (VOC) and oxides of EPA’s regulations at 40 CFR part 50, the requesting the footnote reference be nitrogen (NOX) Motor Vehicle Emission 2008 8-hour ozone NAAQS is attained changed to reflect the most recent Budgets (MVEBs) for the Missouri when the three-year average of the approved plan. portion of the St. Louis area. The annual fourth highest daily maximum 8- EPA’s Response: EPA agrees with the Missouri Department of Natural hour average concentration is equal to commenter that the most recent Resources (MDNR) submitted this or less than 0.075 ppm at all of the monitoring network plan was approved request on September 12, 2016, with a ozone monitoring sites in the area. See on December 19, 2017, and Missouri has supplemental submission on February 40 CFR 50.15 and appendix P to 40 CFR committed to monitoring air quality for 16, 2018. EPA addressed the Illinois part 50. Under the CAA, EPA may verification of continued attainment. In portion of the St. Louis area in a redesignate nonattainment areas to this final rulemaking notice, we clarify separate rulemaking action published in attainment if sufficient complete, that the monitoring network plan used the Federal Register on March 1, 2018. quality-assured data are available to for verification of continued attainment is the plan approved by EPA on DATES: This final rule is effective on determine that the area has attained the September 20, 2018. standard and if it meets the other CAA December 19, 2017. redesignation requirements in section Comment: The commenter requested ADDRESSES: EPA has established a 107(d)(3)(E). The proposed rule clarification on the source of the 2014 docket for this action under Docket ID provides a detailed discussion of how attainment inventory data, since the No. EPA–R07–OAR–2017–0349. All Missouri has met these CAA proposal states that data for the 2014 documents in the docket are listed on requirements. attainment inventory was not the https://www.regulations.gov As discussed in the June 25, 2018, interpolated between the 2011 and 2018 website. Although listed in the index, proposal, quality-assured and certified Ozone NAAQS Emissions Modeling some information is not publicly monitoring data for 2013–2015 show platform inventories, because EPA’s available, i.e., CBI or other information that the St. Louis area has attained the National Emissions Inventory (NEI) was whose disclosure is restricted by statute. 2008 ozone standard. In the unavailable at the time of the Certain other material, such as maintenance plan submitted for the redesignation request. copyrighted material, is not placed on area, Missouri has demonstrated that the EPA’s Response: EPA agrees with the the internet and will be publicly ozone standard will be maintained in commenter that the Agency’s 2014 NEI available only in hard copy form. the area through 2030. Finally, Missouri was not available at the time Missouri Publicly available docket materials are adopted 2030 MVEBs for its portion of submitted its request for redesignation. available through https:// the St. Louis area that are adequate and EPA also agrees that Missouri did not www.regulations.gov or please contact supported by MDNR’s maintenance interpolate data between 2011 and 2018 the person identified in the FOR FURTHER demonstration. to create inventories for 2014. The state INFORMATION CONTACT section for used Missouri-specific 2014 emissions additional information. II. Have the requirements for approval data for the 2014 attainment year. As of a SIP revision been met? FOR FURTHER INFORMATION CONTACT: indicated in the proposal both NOX and Lachala Kemp, Environmental The state’s submission has met the VOC emissions decreased from the base Protection Agency, Air Planning and public notice requirements for the year to the attainment year and helps Development Branch, 11201 Renner redesignation request and maintenance adequately demonstrate that

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improvement in air quality is due to EPA’s ozone season runs from March– section 553(d)(3) because they do not permanent and enforceable emission October and data collected thus far in create any new regulatory requirements reductions. 2018 has yet to be quality assured or such that affected parties would need Comment: The commenter stated that certified by the state. Individual time to prepare before the actions take EPA should not take final action to readings at air quality monitors that effect. approve the redesignation of the St. exceed the level of the NAAQS do not Louis area to attainment because the mean that an area is no longer attaining V. Statutory and Executive Order state’s data indicate most monitoring the NAAQS. In part because ozone Reviews sites in the nonattainment area have concentrations are influenced by Under the Clean Air Act, the exceeded the 2008 ozone NAAQS in just meteorology and subject to variable Administrator is required to approve a the first half of the 2018 ozone season, conditions, attainment of the 2008 SIP submission that complies with the and that past improvements cannot be ozone NAAQS is measured using the provisions of the Act and applicable reasonably attributed to permanent and three-year average design value at all Federal regulations. 42 U.S.C. 7410(k); enforceable reductions in emissions monitoring sites in the area. Moreover, 40 CFR 52.02(a). Thus, in reviewing SIP because of regular exceedances of the as stated in the proposal, the St. Louis submissions, EPA’s role is to approve 2008 NAAQS at monitoring sites. area has also shown a decrease in both state choices, provided that they meet EPA’s Response: Section 107(d)(3)(E) NOX and VOC emissions which the criteria of the CAA. Accordingly, of the CAA allows redesignation of a indicates that improvement in air this action merely approves state law as nonattainment area to attainment of the quality is due to permanent and meeting Federal requirements and does NAAQS provided that: (1) The enforceable emission reductions, rather not impose additional requirements Administrator determines that the area than temporary conditions. beyond those imposed by state law. For has attained the NAAQS; (2) the that reason, this action: IV. What action is EPA taking? Administrator has fully approved the • Is not a significant regulatory action applicable implementation plan for the EPA has determined that the Missouri subject to review by the Office of area under section 110(k) of the CAA; portion of the St. Louis nonattainment Management and Budget under (3) the Administrator determines that area is attaining the 2008 ozone Executive Orders 12866 (58 FR 51735, the improvement in air quality is due to standard based on quality-assured and October 4, 1993) and 13563 (76 FR 3821, permanent and enforceable reductions certified monitoring data for 2013–2015 January 21, 2011); in emissions resulting from and that the Missouri portion of the St. • Is not an Executive Order 13771 (82 implementation of the applicable SIP, Louis area has met the requirements for FR 9339, February 2, 2017) regulatory applicable Federal air pollutant control redesignation under section 107(d)(3)(E) action because SIP approvals are regulations, and other permanent and of the CAA. exempted under Executive Order 12866. enforceable emission reductions; (4) the EPA is thus approving the state’s • Does not impose an information Administrator has fully approved a request to change the designation of the collection burden under the provisions maintenance plan for the area as Missouri portion of the St. Louis area for of the Paperwork Reduction Act (44 meeting the requirements of section the 2008 ozone standard from U.S.C. 3501 et seq.); 175A of the CAA; and (5) the state nonattainment to attainment. EPA is • Is certified as not having a containing the area has met all also approving, as a revision to the significant economic impact on a requirements applicable to the area for Missouri SIP, the state’s maintenance substantial number of small entities the purposes of redesignation under plan for the area. The maintenance plan under the Regulatory Flexibility Act (5 section 110 and part D of the CAA. is designed to keep the Missouri portion U.S.C. 601 et seq.); Specifically, the CAA section of the St. Louis area in attainment of the • Does not contain any unfunded 107(d)(3)(E)(i) requires EPA to 2008 ozone NAAQS through 2030. mandate or significantly or uniquely determine that the area has attained the Finally, EPA finds adequate and is affect small governments, as described applicable NAAQS. An area is attaining approving the newly-established 2030 in the Unfunded Mandates Reform Act the 2008 ozone NAAQS if it meets the MVEBs for the Missouri portion of the of 1995 (Pub. L. 104–4); 2008 ozone NAAQS, as determined in St. Louis area. • Does not have Federalism accordance with 40 CFR 50.15 and EPA has determined that these actions implications as specified in Executive appendix P of part 50, based on three are effective immediately upon Order 13132 (64 FR 43255, August 10, complete, consecutive calendar years of publication under the authority of 5 1999); quality assured air quality data for all U.S.C. 553(d). The purpose of the thirty- • Is not an economically significant monitoring sites in the area. To attain day waiting period prescribed in section regulatory action based on health or the NAAQS, the three-year average of 553(d) is to give affected parties a safety risks subject to Executive Order the annual fourth-highest daily reasonable time to adjust their behavior 13045 (62 FR 19885, April 23, 1997); maximum 8-hour average ozone and prepare before the final rule takes • Is not a significant regulatory action concentrations (ozone design values) at effect. Section 553(d)(1) allows an subject to Executive Order 13211 (66 FR each monitor must not exceed 0.075 effective date less than thirty days after 28355, May 22, 2001); ppm. EPA disagrees with the publication if a substantive rule • Is not subject to requirements of the commenter that final action should not ‘‘relieves a restriction.’’ These actions National Technology Transfer and be taken to redesignate the St. Louis qualify for the exception under section Advancement Act (NTTA) because this area due to data indicating exceedances 553(d)(1) because they relieve the State rulemaking does not involve technical at monitoring sites in the area. of various requirements for the Area. standards; and EPA’s proposed rulemaking was Furthermore, section 553(d)(3) allows • Does not provide EPA with the based on quality assured data from an effective date less than thirty days discretionary authority to address, as 2013–2015 which demonstrated that the after publication ‘‘as otherwise provided appropriate, disproportionate human St. Louis area is attaining the 2008 by the agency for good cause found and health or environmental effects, using ozone NAAQS. In addition, 2014–2016 published with the rule.’’ EPA finds practicable and legally permissible and 2015–2017 data confirm that the good cause to make these actions methods, under Executive Order 12898 area continues to attain that NAAQS. effective immediately pursuant to (59 FR 7629, February 16, 1994).

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In addition, the SIP is not approved reference, Intergovernmental relations, (e) Redesignation to attainment. On to apply on any Indian reservation land Nitrogen dioxide, Ozone, Volatile September 12, 2016, and February 16, or in any other area where EPA or an organic compounds. 2018, Missouri submitted requests to Indian tribe has demonstrated that a 40 CFR Part 81 redesignate its portion of the St. Louis tribe has jurisdiction. In those areas of MO-IL area to attainment of the 2008 Indian country, the rule does not have Environmental protection, ozone standard. The Missouri portion of tribal implications and will not impose Administrative practice and procedure, the St. Louis MO-IL area includes substantial direct costs on tribal Air pollution control, Designations and Jefferson, Franklin, St. Charles, and St. governments or preempt tribal law as classifications, Intergovernmental Louis Counties along with the City of St. specified by Executive Order 13175 (65 relations, Nitrogen dioxide, Ozone, Louis. As part of the redesignation FR 67249, November 9, 2000). Reporting and recordkeeping request, the State submitted a plan for The Congressional Review Act, 5 requirements, Volatile organic maintaining the 2008 ozone standard U.S.C. 801 et seq., as added by the Small compounds. Business Regulatory Enforcement through 2030 in the area as required by Fairness Act of 1996, generally provides Dated: September 13, 2018. section 175A of the Clean Air Act. James B. Gulliford, that before a rule may take effect, the PART 81—DESIGNATION OF AREAS agency promulgating the rule must Regional Administrator, Region 7. FOR AIR QUALITY PLANNING submit a rule report, which includes a For the reasons stated in the PURPOSES copy of the rule, to each House of the preamble, EPA amends 40 CFR parts 52 Congress and to the Comptroller General and 81 as set forth below: ■ of the United States. EPA will submit a 3. The authority citation for part 81 continues to read as follows: report containing this action and other PART 52—APPROVAL AND required information to the U.S. Senate, PROMULGATION OF Authority: 42 U.S.C. 7401, et seq. the U.S. House of Representatives, and IMPLEMENTATION PLANS the Comptroller General of the United Subpart C—Section 107 Attainment States prior to publication of the rule in ■ 1. The authority citation for part 52 Status Designations the Federal Register. A major rule continues to read as follows: cannot take effect until 60 days after it ■ 4. Section 81.326 is amended by Authority: 42 U.S.C. 7401 et seq. is published in the Federal Register. revising the entry for ‘‘St. Louis-St. This action is not a ‘‘major rule’’ as Subpart—AA Missouri Charles-Farmington, MO-IL’’ in the table defined by 5 U.S.C. 804(2). entitled ‘‘Missouri—2008 8-Hour Ozone List of Subjects ■ 2. Amend § 52.1342 by adding NAAQS (Primary and Secondary)’’ to paragraph (e) to read as follows: read as follows: 40 CFR Part 52 Environmental protection, Air § 52.1342 Control strategy: Ozone. § 81.326 Missouri. pollution control, Incorporation by * * * * * * * * * *

MISSOURI—2008 8-HOUR OZONE NAAQS [Primary and secondary]

Designation Classification Designated area Date 1 Type Date 1 Type

St. Louis-St. Charles-Farmington, MO-IL 2: Franklin County ...... 9/20/2018 Attainment. Jefferson County ...... 9/20/2018 Attainment. St. Charles County ...... 9/20/2018 Attainment. St. Louis County ...... 9/20/2018 Attainment. St. Louis City ...... 9/20/2018 Attainment.

******* 1 This date is July 20, 2012, unless otherwise noted. 2 Excludes Indian country located in each area, unless otherwise noted.

* * * * * DEPARTMENT OF TRANSPORTATION SUMMARY: This rulemaking rescinds the [FR Doc. 2018–20326 Filed 9–19–18; 8:45 am] regulation implementing the BILLING CODE 6560–50–P Federal Transit Administration requirement for recipients to conduct a cost-effectiveness analysis before leasing 49 CFR Part 639 public transportation equipment or [Docket No. FTA–2018–0006] facilities with Federal transit funds. The requirement to conduct a cost- RIN 2132–AB34 effectiveness analysis was rescinded by statute in 2015. Capital Leases DATES: This final rule is effective on AGENCY: Federal Transit Administration September 20, 2018. (FTA), Department of Transportation. FOR FURTHER INFORMATION CONTACT: ACTION: Final rule. Mark Montgomery, Office of Chief

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Counsel, (202) 366–1017 or part 200, nor does it alter the award requirement, and the analysis takes [email protected]. Office management requirements in FTA’s approximately a week for transit hours are from 9 a.m. to 5:30 p.m., ET, Circular 5010.1E. agencies to compile and prepare and Monday through Friday, except Federal Under the Administrative Procedure approximately eight hours for FTA to holidays. Act (APA) (5 U.S.C. 553(b)), an agency review and approve the certification. SUPPLEMENTARY INFORMATION: may waive the normal notice and Thus, removing these requirements comment procedure if it finds, for good would provide a maximum average Electronic Access and Filing cause, that it is impracticable, annual cost savings of $32,373 and This document is viewable online unnecessary, or contrary to the public impose no additional costs on through the Federal eRulemaking portal interest. Additionally, 5 U.S.C. 553(d) recipients. at http://www.regulations.gov. Retrieval provides that an agency may waive the Regulatory Flexibility Act help and guidelines are available on the 30-day delayed effective date upon website. It is available 24 hours each finding of good cause. Because FTA finds good cause under day, 365 days a year. An electronic copy Section 3003 of TEA–21 amended 5 U.S.C. 553(b)(3)(B) to waive notice of this document is available for section 5302 to allow a recipient to use and opportunity for comment for this download from the Office of the Federal capital funds to finance the leasing of rule, the provisions of the Regulatory Register home page at: http:// facilities and equipment, ‘‘subject to Flexibility Act (Pub. L. 96–354, 5 U.S.C. www.ofr.gov and the Government regulations that the Secretary prescribes 601–612) do not apply. FTA evaluated Publishing Office web page at: http:// limiting the leasing arrangements to the effects of this action on small www.gpo.gov. those that are more cost-effective than entities and determined the action would not have a significant economic Background purchase or construction.’’ By removing this language, section 3002 of the FAST impact on a substantial number of small 49 CFR part 639 limits capital leasing Act eliminated the requirement limiting entities. FTA hereby certifies that this arrangements for use in public capital leases to those that are more rule will not have a significant transportation to those that are more cost-effective than purchase or economic impact on a substantial cost-effective than purchase or construction. FTA finds good cause that number of small entities. construction. This part implements notice and comment for this rule is Unfunded Mandates Reform Act of 1995 section 3003 of the Transportation unnecessary due to the nature of the FTA has determined that this rule Equity Act for the 21st Century (Pub. L. revisions (i.e., the rule simply carries does not impose unfunded mandates, as 105–178) (TEA–21), which amended out the statutory language found in the defined by the Unfunded Mandates section 5302 of title 49, United States FAST Act). The statutory language does Reform Act of 1995 (Pub. L. 104–4, Code (Section 5302), to allow a recipient not require regulatory interpretation to March 22, 1995, 109 Stat. 48). This rule to use capital funds to finance the carry out its intent, and comments does not include a Federal mandate that leasing of facilities and equipment on cannot alter the regulation given that the may result in expenditures of $155.1 the condition that the leasing statute abrogated its purpose. Further, million or more in any 1 year (when arrangements are more cost-effective the delayed effective date is adjusted for inflation) in 2012 dollars than purchase or construction. This unnecessary because the removal of the for either State, local, and tribal section also required the Secretary to cost-effectiveness analysis requirement governments in the aggregate, or by the promulgate regulations to implement was already made effective by the FAST private sector. Additionally, the the cost-effectiveness limitation. Act. Accordingly, FTA finds good cause definition of ‘‘Federal mandate’’ in the Recently, section 3002 of the Fixing under 5 U.S.C. 553(b)(3)(B) and (d)(3) to Unfunded Mandates Reform Act America’s Surface Transportation Act waive notice and opportunity for excludes financial assistance of the type (Pub. L. 114–357) (FAST Act) amended comment and the delayed effective date. the definition of ‘‘capital project’’ under in which State, local, or tribal section 5302 to remove this requirement Rulemaking Analyses and Notices governments have authority to adjust their participation in the program in and the mandate to promulgate Executive Order 12866 (Regulatory accordance with changes made in the regulations to carry out this Planning and Review), Executive Order program by the Federal Government. requirement. For this reason, FTA is 13563 (Improving Regulation and The Federal Transit Act permits this issuing this final rule to rescind 49 CFR Regulatory Review), Executive Order type of flexibility. part 639. 13771 (Reducing Regulation and FTA will continue to evaluate its Controlling Regulatory Costs), and Executive Order 13132 (Federalism regulations and guidance to promote Department of Transportation (DOT) Assessment) improvements to the capital leasing Regulatory Policies and Procedures process in the least burdensome Executive Order 13132 requires manner. FTA has determined that this agencies to assure meaningful and rulemaking is not a significant timely input by State and local officials Discussion of the Changes regulatory action within the meaning of in the development of regulatory Under the amended statutory Executive Order 12866, and within the policies that may have a substantial definition of ‘‘capital project,’’ capital meaning of DOT regulatory policies and direct effect on the States, on the leases are no longer subject to the procedures. This action complies with relationship between the national requirement or regulation limiting Executive Orders 12866, 13563 and government and the States, or on the leasing arrangements to those that are 13771 to improve regulation. distribution of power and more cost-effective than purchase or FTA classifies this rule as a responsibilities among the various construction. Accordingly, this deregulatory action under Executive levels of government. This action has rulemaking rescinds 49 CFR part 639, Order 13771, because it removes the been analyzed in accordance with the which outlines the procedures for mandatory cost-effectiveness analysis. principles and criteria contained in conducting the cost-effectiveness FTA finds that the cost savings are Executive Order 13132 dated August 4, analysis. This rule does not affect the minor. On average, there are twelve 1999, and FTA determined this action general procurement standards in 2 CFR leases per year subject to the will not have a substantial direct effect

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or sufficient federalism implications on Executive Order 12988 (Civil Justice human health or environmental effects, the States. FTA also determined this Reform) including interrelated social and action will not preempt any State law or This rule meets applicable standards economic effects, of their programs, regulation or affect the States’ ability to in sections 3(a) and 3(b)(2) of Executive policies, and activities on minority and discharge traditional State governmental Order 12988, Civil Justice Reform, to low-income populations. All DOT functions. minimize litigation, eliminate agencies must address compliance with Executive Order 12372 ambiguity, and reduce burden. Executive Order 12898 and the DOT (Intergovernmental Review) Order in all rulemaking activities. On Executive Order 13045 (Protection of August 15, 2012, FTA’s Circular 4703.1 The regulations implementing Children) became effective, which contains Executive Order 12372 regarding FTA has analyzed this rule under guidance for recipients of FTA financial intergovernmental consultation on Executive Order 13045, Protection of assistance to incorporate EJ principles Federal programs and activities apply to into plans, projects, and activities this program. Children from Environmental Health Risks and Safety Risks. FTA certifies (available online at http:// _ _ Paperwork Reduction Act that this action will not cause an www.fta.dot.gov/documents/FTA EJ Circular_7.14-12_FINAL.pdf). Federal agencies must obtain approval environmental risk to health or safety from the Office of Management and that might disproportionately affect FTA has evaluated this action under Budget (OMB) for each collection of children. the Executive Order, the DOT Order, information they conduct, sponsor, or Executive Order 13175 (Tribal and the FTA Circular. The rule rescinds require through regulations. FTA has Consultation) the requirement of conducting cost- analyzed this rule under the Paperwork effectiveness analysis for capital leases, Reduction Act and believes that it does FTA has analyzed this rule under and FTA has determined that this action not impose additional information Executive Order 13175, dated November will not cause disproportionately high collection requirements for the purposes 6, 2000, and believes that it will not and adverse human health and of the Act above and beyond existing have substantial direct effects on one or environmental effects on minority or information collection clearances from more Indian tribes; will not impose low-income populations. OMB. substantial direct compliance costs on Indian tribal governments; and will not Regulation Identifier Number National Environmental Policy Act preempt tribal laws. Therefore, a tribal A Regulation Identifier Number (RIN) Federal agencies are required to adopt summary impact statement is not is assigned to each regulatory action implementing procedures for the required. listed in the Unified Agenda of Federal National Environmental Policy Act Executive Order 13211 (Energy Effects) Regulations. The Regulatory Information (NEPA) that establish specific criteria Service Center publishes the Unified FTA has analyzed this action under for, and identification of, three classes Agenda in April and October of each Executive Order 13211, Actions of actions: (1) Those that normally year. The RIN number contained in the Concerning Regulations That require preparation of an Environmental heading of this document can be used Significantly Affect Energy Supply, Impact Statement, (2) those that to cross-reference this rule with the Distribution, or Use. FTA has normally require preparation of an Unified Agenda. Environmental Assessment, and (3) determined that this action is not a those that are categorically excluded significant energy action under that List of Subjects in 49 CFR Part 639 from further NEPA review (40 CFR order and is not likely to have a 1507.3(b)). This rule qualifies for significant adverse effect on the supply, Grant programs—transportation, Mass categorical exclusions under 23 CFR distribution, or use of energy. Therefore, transportation. 771.118(c)(4) (planning and a Statement of Energy Effects is not Issued in Washington, DC, under authority administrative activities that do not required. delegated in 49 CFR 1.90: involve or lead directly to construction). Executive Order 12898 (Environmental K. Jane Williams, FTA has evaluated whether the rule will Justice) Acting Administrator. involve unusual or extraordinary circumstances and has determined that Executive Order 12898 (Federal Title 49—Transportation Actions to Address Environmental it will not. PART 639—[REMOVED AND Justice in Minority Populations and RESERVED] Executive Order 12630 (Taking of Low-Income Populations) and DOT Private Property) Order 5610.2(a) (77 FR 27534, May 10, FTA has analyzed this rule under 2012) (available online at http:// ■ In consideration of the foregoing, and Executive Order 12630, Governmental www.fhwa.dot.gov/environment/ under the authority of 49 U.S.C. 5302 Actions and Interference with environmental_justice/ej_at_dot/order_ and Public Law 114–357, amend 49 CFR Constitutionally Protected Property 56102a/index.cf) require DOT agencies chapter VI by removing and reserving Rights. FTA does not believe this rule to achieve Environmental Justice (EJ) as part 639, consisting of §§ 639.1 through effects a taking of private property or part of their mission by identifying and 639.33. otherwise has taking implications under addressing, as appropriate, [FR Doc. 2018–20474 Filed 9–19–18; 8:45 am] Executive Order 12630. disproportionately high and adverse BILLING CODE P

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Proposed Rules Federal Register Vol. 83, No. 183

Thursday, September 20, 2018

This section of the FEDERAL REGISTER FAA Order 7400.11C, Airspace presented are particularly helpful in contains notices to the public of the proposed Designations and Reporting Points, and developing reasoned regulatory issuance of rules and regulations. The subsequent amendments can be viewed decisions on the proposal. Comments purpose of these notices is to give interested on line at http://www.faa.gov/air_ are specifically invited on the overall persons an opportunity to participate in the traffic/publications/. For further regulatory, aeronautical, economic, rule making prior to the adoption of the final rules. information, you can contact the environmental, and energy-related Airspace Policy Group, Federal Aviation aspects of the proposal. Administration, 800 Independence Communications should identify both DEPARTMENT OF TRANSPORTATION Avenue SW, Washington, DC 20591; docket numbers (Docket No. FAA– telephone: (202) 267–8783. The Order is 2018–0745 and Airspace Docket No. 18– Federal Aviation Administration also available for inspection at the ASO–15) and be submitted in triplicate National Archives and Records to DOT Docket Operations (see 14 CFR Part 71 Administration (NARA). For ADDRESSES section for the address and information on the availability of FAA phone number.) You may also submit [Docket No. FAA–2018–0745; Airspace Order 7400.11C at NARA, call (202) comments through the internet at http:// Docket No. 18–ASO–15] 741–6030, or go to https:// www.regulations.gov. Persons wishing the FAA to RIN 2120–AA66 www.archives.gov/federal-register/cfr/ ibr-locations.html. acknowledge receipt of their comments Proposed Amendment of Class E FAA Order 7400.11, Airspace on this action must submit with those Airspace, Mountain City, TN; and Designations and Reporting Points, is comments a self-addressed stamped Proposed Establishment of Class E published yearly and effective on postcard on which the following Airspace; Elizabethton, TN September 15. statement is made: ‘‘Comments to FAA Docket No. FAA–2018–0745; Airspace FOR FURTHER INFORMATION CONTACT: John AGENCY: Docket No. 18–ASO–15.’’ The postcard Federal Aviation Fornito, Operations Support Group, will be date/time stamped and returned Administration (FAA), DOT. Eastern Service Center, Federal Aviation to the commenter. ACTION: Notice of proposed rulemaking Administration, 1701 Columbia Avenue, (NPRM). All communications received before College Park, GA 30337; telephone (404) the specified closing date for comments 305–6364. SUMMARY: This action proposes to will be considered before taking action amend Class E airspace extending SUPPLEMENTARY INFORMATION: on the proposed rule. The proposal upward from 700 feet above the surface Authority for This Rulemaking contained in this document may be in Mountain City, TN, to accommodate changed in light of the comments The FAA’s authority to issue rules new area navigation (RNAV) global received. All comments submitted will regarding aviation safety is found in positioning system (GPS) standard be available for examination in the Title 49 of the United States Code. instrument approach procedures serving public docket both before and after the Subtitle I, Section 106 describes the Johnson County Airport. In addition, comment closing date. A report authority of the FAA Administrator. Class E airspace extending upward from summarizing each substantive public Subtitle VII, Aviation Programs, 700 feet above the surface would be contact with FAA personnel concerned describes in more detail the scope of the established in Elizabethton, TN to with this rulemaking will be filed in the agency’s authority. This rulemaking is accommodate area navigation (RNAV) docket. promulgated under the authority global positioning system (GPS) described in Subtitle VII, Part A, Availability of NPRMs standard instrument approach Subpart I, Section 40103. Under that procedures at Elizabethton Municipal An electronic copy of this document section, the FAA is charged with Airport. Controlled airspace is necessary may be downloaded through the prescribing regulations to assign the use for the safety and management of internet at http://www.regulations.gov. of airspace necessary to ensure the instrument flight rules (IFR) operations Recently published rulemaking safety of aircraft and the efficient use of at these airports. documents can also be accessed through airspace. This regulation is within the the FAA’s web page at http:// DATES: Comments must be received on scope of that authority as it would www.faa.gov/air_traffic/publications/ or before November 5, 2018. amend Class E airspace at Johnson airspace_amendments/. ADDRESSES: Send comments on this County Airport, Mountain City, TN, and You may review the public docket proposal to: The U.S. Department of establish Class E airspace at containing the proposal, any comments Transportation, Docket Operations, 1200 Elizabethton Municipal, Elizabethton, received and any final disposition in New Jersey Avenue SE, West Building TN, to support IFR operations at these person in the Dockets Office (see the Ground Floor, Room W12–140, airports. ADDRESSES section for address and Washington, DC 20590–0001; phone number) between 9:00 a.m. and Telephone: (800) 647–5527, or (202) Comments Invited 5:00 p.m., Monday through Friday, 366–9826. You must identify the Docket Interested persons are invited to except federal holidays. An informal No. FAA–2018–0745; Airspace Docket comment on this proposed rulemaking docket may also be examined between No. 18–ASO–15, at the beginning of by submitting such written data, views, 8:00 a.m. and 4:30 p.m., Monday your comments. You may also submit or arguments, as they may desire. through Friday, except federal holidays comments through the internet at http:// Comments that provide the factual basis at the office of the Eastern Service www.regulations.gov. supporting the views and suggestions Center, Federal Aviation

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Administration, Room 350, 1701 as the anticipated impact is so minimal. radius of Elizabethton Municipal Airport, Columbia Avenue, College Park, GA Since this is a routine matter that will and within 4-miles each side of the 243° 30337. only affect air traffic procedures and air bearing from the airport, extending from the navigation, it is certified that this 9.5-mile radius to 15-miles southwest of the Availability and Summary of airport. proposed rule, when promulgated, will Documents for Incorporation by Issued in College Park, Georgia, on Reference not have a significant economic impact on a substantial number of small entities September 10, 2018. This document proposes to amend under the criteria of the Regulatory Christopher Cox, FAA Order 7400.11C, Airspace Flexibility Act. Acting Manager, Operations Support Group Designations and Reporting Points, Eastern Service Center, Air Traffic dated August 13, 2018, and effective Environmental Review Organization. September 15, 2018. FAA Order This proposal will be subject to an [FR Doc. 2018–20225 Filed 9–19–18; 8:45 am] 7400.11C is publicly available as listed environmental analysis in accordance BILLING CODE 4910–13–P in the ADDRESSES section of this with FAA Order 1050.1F, document. FAA Order 7400.11C lists ‘‘Environmental Impacts: Policies and Class A, B, C, D, and E airspace areas, Procedures’’ prior to any FAA final DEPARTMENT OF TRANSPORTATION air traffic service routes, and reporting regulatory action. points. Federal Aviation Administration Lists of Subjects in 14 CFR Part 71 The Proposal Airspace, Incorporation by reference, 14 CFR Part 71 The FAA proposes an amendment to Navigation (air). [Docket No. FAA–2018–0698; Airspace Title 14 Code of Federal Regulations (14 The Proposed Amendment Docket No. 18–AGL–20] CFR) part 71 to amend Class E airspace extending upward from 700 feet or more In consideration of the foregoing, the RIN 2120–AA66 above the surface at Johnson County Federal Aviation Administration Airport, Mountain City, TN, by proposes to amend 14 CFR part 71 as Proposed Amendment of Class D increasing the northeast extension to follows: Airspace; Pontiac, MI 14.4 miles (from 10.9 miles), and PART 71—DESIGNATION OF CLASS A, AGENCY: Federal Aviation creating a 14-mile extension southwest Administration (FAA), DOT. of the airport, to accommodate new area B, C, D, AND E AIRSPACE AREAS; AIR ACTION: Notice of proposed rulemaking navigation (RNAV) global positioning TRAFFIC SERVICE ROUTES; AND (NPRM). system (GPS) standard instrument REPORTING POINTS approach procedures at the airport. ■ 1. The authority citation for part 71 SUMMARY: This action proposes to Additionally, Class E airspace continues to read as follows: amend Class D airspace at Oakland extending upward from 700 feet above County International Airport, Pontiac, Authority: 49 U.S.C. 106(f), 106(g); 40103, the surface would be established at MI. The FAA is proposing this action as Elizabethton Municipal Airport, 40113, 40120; E.O. 10854, 24 FR 9565, 3 CFR, 1959–1963 Comp., p. 389. the result of an airspace review caused Elizabethton, TN, within a 9.5-mile by the decommissioning of the Pontiac radius of the airport, and within 4-miles § 71.1 [Amended] VHF omnidirectional range (VOR) ° each side of the 243 bearing from the ■ 2. The incorporation by reference in navigation aid, which provided airport, extending from the 9.5-mile 14 CFR 71.1 of Federal Aviation navigation information for the radius to 15-miles southwest of the Administration Order 7400.11C, instrument procedures at this airport, as airport to accommodate RNAV (GPS) Airspace Designations and Reporting part of the VOR Minimum Operational standard instrument approach Points, dated August 13, 2018, and Network (MON) Program. This action procedures for IFR operations at these effective September 15, 2018, is would also replace the outdated term airports. amended as follows: Airport/Facility Directory with Chart Class E airspace designations are Paragraph 6005 Class E Airspace Areas Supplement. Airspace redesign is published in Paragraph 6005, of FAA necessary for the safety and Order 7400.11C, dated August 13, 2018, Extending Upward From 700 Feet or More Above the Surface of the Earth. management of instrument flight rules and effective September 15, 2018, which (IFR) operations at this airport. is incorporated by reference in 14 CFR * * * * * DATES: Comments must be received on 71.1. The Class E airspace designation ASO TN E5 Mountain City, TN [Amended] or before November 5, 2018. listed in this document will be Johnson County Airport, TN published subsequently in the Order. (Lat. 36°25′04″ N, long. 81°49′31″ W) ADDRESSES: Send comments on this proposal to the U.S. Department of Regulatory Notices and Analyses That airspace extending upward from 700 feet above the surface within a 6.7-mile Transportation, Docket Operations, The FAA has determined that this radius of the Johnson County Airport, and West Building Ground Floor, Room proposed regulation only involves an within 3.2 miles each side of the 066° bearing W12–140, 1200 New Jersey Avenue SE, established body of technical from the airport, extending from the 6.7-mile Washington, DC 20590; telephone (202) regulations for which frequent and radius to 14.4 miles northeast of the airport, 366–9826, or (800) 647–5527. You must routine amendments are necessary to and within 3.2 miles each side of the 251° identify FAA Docket No. FAA–2018– keep them operationally current. It, bearing from the airport, extending from the 0698; Airspace Docket No. 18–AGL–20, therefore: (1) Is not a ‘‘significant 6.7-mile radius to 14-miles southwest of the at the beginning of your comments. You airport. regulatory action’’ under Executive may also submit comments through the Order 12866; (2) is not a ‘‘significant ASO TN E5 Elizabethton, TN [New] internet at http://www.regulations.gov. rule’’ under DOT Regulatory Policies Elizabethton Municipal Airport, TN You may review the public docket and Procedures (44 FR 11034; February (Lat. 36°22′16″ N, long. 82°10′24″ W) containing the proposal, any comments 26, 1979); and (3) does not warrant That airspace extending upward from 700 received, and any final disposition in preparation of a Regulatory Evaluation feet above the surface within a 9.5-mile person in the Dockets Office between

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9:00 a.m. and 5:00 p.m., Monday aspects of the proposal. D airspace at Oakland County through Friday, except Federal holidays. Communications should identify both International Airport, Ponitac, MI, FAA Order 7400.11C, Airspace docket numbers and be submitted in adding an extension 1.0 mile each side Designations and Reporting Points, and triplicate to the address listed above. of the 274° bearing from the airport subsequent amendments can be viewed Commenters wishing the FAA to extending from the 4.2-mile radius to online at http://www.faa.gov/air_traffic/ acknowledge receipt of their comments 4.4 miles west of the airport; and adding publications/. For further information, on this notice must submit with those an extension 1.0 mile each side of the you can contact the Airspace Policy comments a self-addressed, stamped 275° bearing from the Oakland County Group, Federal Aviation postcard on which the following Intl: RWY 09R–LOC extending from the Administration, 800 Independence statement is made: ‘‘Comments to 4.2-mile radius to 4.4 miles west of the Avenue SW, Washington, DC 20591; Docket No. FAA–2018–0698; Airspace Oakland County Intl: RWY 09R–LOC. telephone: (202) 267–8783. The Order is Docket No. 18–AGL–20.’’ The postcard This action also would make an also available for inspection at the will be date/time stamped and returned editorial change to the airspace legal National Archives and Records to the commenter. description replacing ‘‘Airport/Facility Administration (NARA). For All communications received before Directory’’ with ‘‘Chart Supplement’’. information on the availability of FAA the specified closing date for comments This action is necessary due to an Order 7400.11C at NARA, call (202) will be considered before taking action airspace review caused by the 741–6030, or go to http:// on the proposed rule. The proposal decommissioning of the Pontiac VOR, www.archives.gov/federal-register/cfr/ contained in this notice may be changed which provided navigation information ibr-locations.html. in light of the comments received. A to the instrument procedures at this FAA Order 7400.11, Airspace report summarizing each substantive airport, as part of the VOR MON Designations and Reporting Points, is public contact with FAA personnel Program. published yearly and effective on concerned with this rulemaking will be Class D airspace designations are September 15. filed in the docket. published in paragraph 5000 of FAA FOR FURTHER INFORMATION CONTACT: Availability of NPRMs Order 7400.11C, dated August 13, 2018, Jeffrey Claypool, Federal Aviation An electronic copy of this document and effective September 15, 2018, which Administration, Operations Support may be downloaded through the is incorporated by reference in 14 CFR Group, Central Service Center, 10101 internet at http://www.regulations.gov. 71.1. The Class D airspace designation Hillwood Parkway, Fort Worth, TX Recently published rulemaking listed in this document will be 76177; telephone (817) 222–5711. documents can also be accessed through published subsequently in the Order. SUPPLEMENTARY INFORMATION: the FAA’s web page at http:// Regulatory Notices and Analyses _ Authority for This Rulemaking www.faa.gov/air traffic/publications/ airspace_amendments/. The FAA has determined that this The FAA’s authority to issue rules You may review the public docket regulation only involves an established regarding aviation safety is found in containing the proposal, any comments body of technical regulations for which Title 49 of the United States Code. received, and any final disposition in frequent and routine amendments are Subtitle I, Section 106 describes the person in the Dockets Office (see the necessary to keep them operationally authority of the FAA Administrator. ADDRESSES section for the address and current, is non-controversial and Subtitle VII, Aviation Programs, phone number) between 9:00 a.m. and unlikely to result in adverse or negative describes in more detail the scope of the 5:00 p.m., Monday through Friday, comments. It, therefore: (1) Is not a agency’s authority. This rulemaking is except federal holidays. An informal ‘‘significant regulatory action’’ under promulgated under the authority docket may also be examined during Executive Order 12866; (2) is not a described in Subtitle VII, Part A, normal business hours at the Federal ‘‘significant rule’’ under DOT Subpart I, Section 40103. Under that Aviation Administration, Air Traffic Regulatory Policies and Procedures (44 section, the FAA is charged with Organization, Central Service Center, FR 11034; February 26, 1979); and (3) prescribing regulations to assign the use Operations Support Group, 10101 does not warrant preparation of a of airspace necessary to ensure the Hillwood Parkway, Fort Worth, TX regulatory evaluation as the anticipated safety of aircraft and the efficient use of 76177. impact is so minimal. Since this is a airspace. This regulation is within the routine matter that will only affect air scope of that authority as it would Availability and Summary of traffic procedures and air navigation, it amend Class D airspace at Oakland Documents for Incorporation by is certified that this rule, when County International Airport, Pontiac, Reference promulgated, would not have a MI, to support IFR operations at this This document proposes to amend significant economic impact on a airport. FAA Order 7400.11C, Airspace substantial number of small entities under the criteria of the Regulatory Comments Invited Designations and Reporting Points, dated August 13, 2018, and effective Flexibility Act. Interested parties are invited to September 15, 2018. FAA Order Environmental Review participate in this proposed rulemaking 7400.11C is publicly available as listed by submitting such written data, views, in the ADDRESSES section of this This proposal will be subject to an or arguments, as they may desire. document. FAA Order 7400.11C lists environmental analysis in accordance Comments that provide the factual basis Class A, B, C, D, and E airspace areas, with FAA Order 1050.1F, supporting the views and suggestions air traffic service routes, and reporting ‘‘Environmental Impacts: Policies and presented are particularly helpful in points. Procedures’’ prior to any FAA final developing reasoned regulatory regulatory action. decisions on the proposal. Comments The Proposal List of Subjects in 14 CFR Part 71 are specifically invited on the overall The FAA is proposing an amendment regulatory, aeronautical, economic, to Title 14 Code of Federal Regulations Airspace, Incorporation by reference, environmental, and energy-related (14 CFR) part 71 by amending the Class Navigation (air).

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The Proposed Amendment DEPARTMENT OF TRANSPORTATION www.archives.gov/federal-register/cfr/ ibr-locations.html. Accordingly, pursuant to the Federal Aviation Administration FAA Order 7400.11, Airspace authority delegated to me, the Federal Designations and Reporting Points, is Aviation Administration proposes to 14 CFR Part 71 published yearly and effective on amend 14 CFR part 71 as follows: September 15. [Docket No. FAA–2018–0685; Airspace FOR FURTHER INFORMATION CONTACT: PART 71—DESIGNATION OF CLASS A, Docket No. 18–AGL–19] Jeffrey Claypool, Federal Aviation B, C, D, AND E AIRSPACE AREAS; AIR RIN 2120–AA66 Administration, Operations Support TRAFFIC SERVICE ROUTES; AND Group, Central Service Center, 10101 REPORTING POINTS Proposed Amendment of Class D Hillwood Parkway, Fort Worth, TX Airspace; Detroit, MI 76177; telephone (817) 222–5711. ■ 1. The authority citation for 14 CFR SUPPLEMENTARY INFORMATION: part 71 continues to read as follows: AGENCY: Federal Aviation Administration (FAA), DOT. Authority for This Rulemaking Authority: 49 U.S.C. 106(f), 106(g); 40103, ACTION: Notice of proposed rulemaking 40113, 40120; E.O. 10854, 24 FR 9565, 3 CFR, The FAA’s authority to issue rules (NPRM). 1959–1963 Comp., p. 389. regarding aviation safety is found in SUMMARY Title 49 of the United States Code. § 71.1 [Amended] : This action proposes to amend Class D airspace at Coleman A. Subtitle I, Section 106 describes the ■ 2. The incorporation by reference in Young Municipal Airport (formerly authority of the FAA Administrator. 14 CFR 71.1 of FAA Order 7400.11C, Detroit City Airport), Detroit, MI, by Subtitle VII, Aviation Programs, Airspace Designations and Reporting changing the airspace designation to describes in more detail the scope of the Points, dated August 13, 2018, and Detroit, MI, thereby removing the old agency’s authority. This rulemaking is effective September 15, 2018, is airport name. The name and geographic promulgated under the authority amended as follows: coordinates of the airport also would be described in Subtitle VII, Part A, updated to coincide with the FAA’s Subpart I, Section 40103. Under that Paragraph 5000 Class D Airspace. aeronautical database. This action is section, the FAA is charged with * * * * * necessary to keep information current prescribing regulations to assign the use of airspace necessary to ensure the AGL MI D Pontiac, MI [Amended] for the safety and management of aircraft within the national airspace safety of aircraft and the efficient use of Oakland County International Airport, MI system. airspace. This regulation is within the (Lat. 42°39′56″ N, long. 83°25′14″ W) scope of that authority as it would Oakland County Intl: RWY 09R–LOC DATES: Comments must be received on amend Class D airspace at Coleman A. (Lat. 42°39′56″ N, long. 83°24′16″ W) or before November 5, 2018. Young Memorial Airport, Detroit, MI. ADDRESSES: Send comments on this That airspace extending upward from the Comments Invited surface to and including 3,500 feet MSL proposal to the U.S. Department of within a 4.2-mile radius of Oakland County Transportation, Docket Operations, Interested parties are invited to International Airport, and within 1.0 mile West Building Ground Floor, Room participate in this proposed rulemaking each side of the 274° bearing from the airport W12–140, 1200 New Jersey Avenue SE, by submitting such written data, views, extending from the 4.2-mile radius to 4.4 Washington, DC 20590; telephone (202) or arguments, as they may desire. miles west of the airport, and within 1.0 mile 366–9826, or (800) 647–5527. You must Comments that provide the factual basis each side of the 275° bearing from the identify FAA Docket No. FAA–2018– supporting the views and suggestions Oakland County Intl: RWY 09R–LOC 0685; Airspace Docket No. 18–AGL–19, presented are particularly helpful in extending from the 4.2-mile radius to 4.4 at the beginning of your comments. You developing reasoned regulatory miles from the Oakland County Intl: RWY may also submit comments through the decisions on the proposal. Comments 09R–LOC. This Class D airspace area is internet at http://www.regulations.gov. are specifically invited on the overall effective during the specific dates and times You may review the public docket regulatory, aeronautical, economic, established in advance by a Notice to containing the proposal, any comments environmental, and energy-related Airmen. The effective date and time will received, and any final disposition in aspects of the proposal. thereafter be continuously published in the person in the Dockets Office between Communications should identify both Chart Supplement. 9:00 a.m. and 5:00 p.m., Monday docket numbers and be submitted in through Friday, except Federal holidays. triplicate to the address listed above. Issued in Fort Worth, Texas, on September FAA Order 7400.11C, Airspace Commenters wishing the FAA to 10, 2018. Designations and Reporting Points, and acknowledge receipt of their comments Walter Tweedy, subsequent amendments can be viewed on this notice must submit with those Acting Manager, Operations Support Group, online at http://www.faa.gov/air_traffic/ comments a self-addressed, stamped ATO Central Service Center. publications/. For further information, postcard on which the following [FR Doc. 2018–20405 Filed 9–19–18; 8:45 am] you can contact the Airspace Policy statement is made: ‘‘Comments to BILLING CODE 4910–13–P Group, Federal Aviation Docket No. FAA–2018–0685; Airspace Administration, 800 Independence Docket No. 18–AGL–19.’’ The postcard Avenue SW, Washington, DC 20591; will be date/time stamped and returned telephone: (202) 267–8783. The Order is to the commenter. also available for inspection at the All communications received before National Archives and Records the specified closing date for comments Administration (NARA). For will be considered before taking action information on the availability of FAA on the proposed rule. The proposal Order 7400.11C at NARA, call (202) contained in this notice may be changed 741–6030, or go to http:// in light of the comments received. A

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report summarizing each substantive Regulatory Notices and Analyses That airspace extending upward from the surface to and including 3,100 feet MSL public contact with FAA personnel The FAA has determined that this concerned with this rulemaking will be within a 4.1-mile radius of the Coleman A. regulation only involves an established Young Municipal Airport. filed in the docket. body of technical regulations for which Issued in Fort Worth, Texas, on September Availability of NPRMs frequent and routine amendments are 10, 2018. necessary to keep them operationally An electronic copy of this document Walter Tweedy, may be downloaded through the current, is non-controversial and unlikely to result in adverse or negative Acting Manager, Operations Support Group, internet at http://www.regulations.gov. ATO Central Service Center. Recently published rulemaking comments. It, therefore: (1) Is not a ‘‘significant regulatory action’’ under [FR Doc. 2018–20403 Filed 9–19–18; 8:45 am] documents can also be accessed through BILLING CODE 4910–13–P the FAA’s web page at http:// Executive Order 12866; (2) is not a www.faa.gov/air_traffic/publications/ ‘‘significant rule’’ under DOT Regulatory Policies and Procedures (44 airspace_amendments/. DEPARTMENT OF TRANSPORTATION You may review the public docket FR 11034; February 26, 1979); and (3) containing the proposal, any comments does not warrant preparation of a Federal Aviation Administration received, and any final disposition in regulatory evaluation as the anticipated person in the Dockets Office (see the impact is so minimal. Since this is a 14 CFR Part 71 ADDRESSES section for the address and routine matter that will only affect air traffic procedures and air navigation, it [Docket No. FAA–2018–0744; Airspace phone number) between 9:00 a.m. and Docket No. 18–ASO–14] 5:00 p.m., Monday through Friday, is certified that this rule, when except federal holidays. An informal promulgated, would not have a RIN 2120–AA66 docket may also be examined during significant economic impact on a normal business hours at the Federal substantial number of small entities Proposed Establishment of Class E Aviation Administration, Air Traffic under the criteria of the Regulatory Airspace, and Amendment of Class D Organization, Central Service Center, Flexibility Act. Airspace and Class E Airspace; Dothan, AL Operations Support Group, 10101 Environmental Review Hillwood Parkway, Fort Worth, TX AGENCY: Federal Aviation This proposal will be subject to an 76177. Administration (FAA), DOT. environmental analysis in accordance Availability and Summary of with FAA Order 1050.1F, ACTION: Notice of proposed rulemaking Documents for Incorporation by ‘‘Environmental Impacts: Policies and (NPRM). Reference Procedures’’ prior to any FAA final SUMMARY: This action proposes to This document proposes to amend regulatory action. establish Class E surface airspace at FAA Order 7400.11C, Airspace List of Subjects in 14 CFR Part 71 Dothan Regional Airport, Dothan, AL. Designations and Reporting Points, The Class E surface airspace would be dated August 13, 2018, and effective Airspace, Incorporation by reference, established for the safety of aircraft September 15, 2018. FAA Order Navigation (air). landing and departing the airport when 7400.11C is publicly available as listed The Proposed Amendment the air traffic control tower is closed. in the ADDRESSES section of this Also, this action proposes to amend Accordingly, pursuant to the document. FAA Order 7400.11C lists Class D airspace by updating the authority delegated to me, the Federal Class A, B, C, D, and E airspace areas, airport’s name and geographic Aviation Administration proposes to air traffic service routes, and reporting coordinates, as well as replacing the amend 14 CFR part 71 as follows: points. outdated term ‘Airport/Facility The Proposal PART 71—DESIGNATION OF CLASS A, Directory’ with ‘Chart Supplement’. B, C, D, AND E AIRSPACE AREAS; AIR Additionally, the geographic The FAA is proposing an amendment coordinates of the airport and Wiregrass to Title 14 Code of Federal Regulations TRAFFIC SERVICE ROUTES; AND REPORTING POINTS VORTAC would be adjusted in the (14 CFR) part 71 amending the Class D associated Class E airspace to match the airspace by updating for the location in ■ 1. The authority citation for 14 CFR FAA’s aeronautical database; as well as the header of the airspace legal part 71 continues to read as follows: removing the part-time status of the description to Detroit, MI (previously airspace for Class E airspace designated Detroit City Airport, MI), at Coleman A. Authority: 49 U.S.C. 106(f), 106(g); 40103, as an extension to a Class D surface area. Young Municipal Airport (formerly 40113, 40120; E.O. 10854, 24 FR 9565, 3 CFR, 1959–1963 Comp., p. 389. Controlled airspace is necessary for the Detroit City Airport), Detroit, MI, to safety and management of instrument comply with FAA Order 7400.2L, § 71.1 [Amended] flight rules (IFR) operations at this Procedures for Handling Airspace ■ airport. Matters. The name and geographic 2. The incorporation by reference in coordinates of the airport would also be 14 CFR 71.1 of FAA Order 7400.11C, DATES: Comments must be received on updated to coincide with the FAA’s Airspace Designations and Reporting or before November 5, 2018. aeronautical database. Points, dated August 13, 2018, and ADDRESSES: Send comments on this rule Class D airspace designations are effective September 15, 2018, is to: U.S. Department of Transportation, published in paragraph 5000 of FAA amended as follows: Docket Operations, 1200 New Jersey Order 7400.11C, dated August 13, 2018, Paragraph 5000 Class D Airspace. Avenue SE, West Bldg. Ground Floor, and effective September 15, 2018, which Rm. W12–140, Washington, DC 20590; * * * * * is incorporated by reference in 14 CFR Telephone: 1–800–647–5527, or (202) 71.1. The Class D airspace designation AGL MI D Detroit, MI [Amended] 366–9826. You must identify the Docket listed in this document will be Coleman A. Young Municipal Airport, MI No. FAA–2018–0744; Airspace Docket published subsequently in the Order. (Lat. 42°24′34″ N, long. 83°00′36″ W) No. 18–ASO–14, at the beginning of

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your comments. You may also submit or arguments, as they may desire. except federal holidays. An informal and review received comments through Comments that provide the factual basis docket may also be examined between the internet at http:// supporting the views and suggestions 8:00 a.m. and 4:30 p.m., Monday www.regulations.gov. You may review presented are particularly helpful in through Friday, except federal holidays the public docket containing the developing reasoned regulatory at the office of the Eastern Service proposal, any comments received, and decisions on the proposal. Comments Center, Federal Aviation any final disposition in person in the are specifically invited on the overall Administration, Room 350, 1701 Dockets Office between 9:00 a.m. and regulatory, aeronautical, economic, Columbia Avenue, College Park, GA 5:00 p.m., Monday through Friday, environmental, and energy-related 30337. except federal holidays. aspects of the proposal. Availability and Summary of FAA Order 7400.11C, Airspace Communications should identify both Documents for Incorporation by Designations and Reporting Points, and docket numbers (Docket No. FAA– Reference subsequent amendments can be viewed 2018–0744 and Airspace Docket No. 18– on line at http://www.faa.gov/air_ ASO–14) and be submitted in triplicate This document proposes to amend traffic/publications/. For further to DOT Docket Operations (see FAA Order 7400.11C, Airspace information, you can contact the ADDRESSES section for the address and Designations and Reporting Points, Airspace Policy Group, Federal Aviation phone number.) You may also submit dated August 13, 2018, and effective Administration, 800 Independence comments through the internet at http:// September 15, 2018. FAA Order Avenue SW, Washington, DC 20591; www.regulations.gov. 7400.11C is publicly available as listed telephone: (202) 267–8783. The Order is Persons wishing the FAA to in the ADDRESSES section of this also available for inspection at the acknowledge receipt of their comments document. FAA Order 7400.11C lists National Archives and Records on this action must submit with those Class A, B, C, D, and E airspace areas, Administration (NARA). For comments a self-addressed stamped air traffic service routes, and reporting information on the availability of FAA postcard on which the following points. Order 7400.11C at NARA, call (202) statement is made: ‘‘Comments to FAA The Proposal 741–6030, or go to https:// Docket No. FAA–2018–0744; Airspace www.archives.gov/federal-register/cfr/ Docket No. 18–ASO–14.’’ The postcard The FAA is considering an ibr-locations.html. will be date/time stamped and returned amendment to Title 14, Code of Federal FAA Order 7400.11, Airspace to the commenter. Regulations (14 CFR) part 71 by: All communications received before Designations and Reporting Points, is Amending Class D airspace at Dothan the specified closing date for comments published yearly and effective on Regional Airport, Dothan, AL by will be considered before taking action September 15. recognizing the airport name change to on the proposed rule. The proposal Dothan Regional Airport (formerly FOR FURTHER INFORMATION CONTACT: John contained in this document may be Dothan Airport), and adjusting the Fornito, Operations Support Group, changed in light of the comments geographic coordinates of the airport to Eastern Service Center, Federal Aviation received. All comments submitted will be in concert with the FAA’s Administration, 1701 Columbia Avenue, be available for examination in the aeronautical database. Also, this action College Park, GA 30337; telephone (404) public docket both before and after the would make an editorial change 305–6364. comment closing date. A report replacing the term ‘‘Airport/Facility SUPPLEMENTARY INFORMATION: summarizing each substantive public Directory’’ with the term ‘‘Chart contact with FAA personnel concerned Authority for This Rulemaking Supplement’’ in the airspace legal with this rulemaking will be filed in the description; The FAA’s authority to issue rules docket. All communications received on regarding aviation safety is found in title or before the specified closing date for Establishing Class E surface area 49 of the United States Code. Subtitle I, comments will be considered before airspace within a 4.7-mile radius of Section 106 describes the authority of taking action on the proposed rule. The Dothan Regional Airport, Dothan, AL, the FAA Administrator. Subtitle VII, proposal contained in this notice may for the safety of aircraft landing and Aviation Programs, describes in more be changed in light of the comments departing the airport after the air traffic detail the scope of the agency’s received. A report summarizing each control tower closes; authority. This proposed rulemaking is substantive public contact with FAA Amending Class E airspace designated promulgated under the authority personnel concerned with this as an extension to a Class D surface area described in Subtitle VII, Part A, rulemaking will be filed in the docket. by adjusting the geographic coordinates Subpart I, Section 40103. Under that of the airport and the Wiregrass section, the FAA is charged with Availability of NPRMs VORTAC to be in concert with the prescribing regulations to assign the use An electronic copy of this document FAA’s aeronautical database. of airspace necessary to ensure the may be downloaded through the In addition, the part-time status safety of aircraft and the efficient use of internet at http://www.regulations.gov. would be removed from this airspace airspace. This regulation is within the Recently published rulemaking description, as the airspace is scope of that authority, as it would documents can also be accessed through continuously active; and establish Class E surface airspace and the FAA’s web page at http:// Amending Class E airspace extending amend Class D airspace and Class E www.faa.gov/air_traffic/publications/ upward from 700 feet above the surface airspace at Dothan Regional Airport, airspace_amendments/. at Dothan Regional Airport, Dothan, AL, Dothan, AL, to support IFR operations at You may review the public docket by adjusting the geographic coordinates this airport. containing the proposal, any comments of the airport and the Wiregrass received and any final disposition in VORTAC to be in concert with the Comments Invited person in the Dockets Office (see the FAA’s aeronautical database, and by Interested persons are invited to ADDRESSES section for address and recognizing the airport name change to comment on this proposed rulemaking phone number) between 9:00 a.m. and Dothan Regional Airport (formerly by submitting such written data, views, 5:00 p.m., Monday through Friday, Dothan Airport).

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Class D and Class E airspace Points, dated August 13, 2018, and Issued in College Park, Georgia, on designations are published in effective September 15, 2018, is September 10, 2018. Paragraphs 5000, 6002, 6004, and 6005, amended as follows: Christopher Cox, respectively of FAA Order 7400.11C, Acting Manager, Operations Support Group, dated August 13, 2018, and effective Paragraph 5000 Class D Airspace. Eastern Service Center, Air Traffic September 15, 2018, which is * * * * * Organization. incorporated by reference in 14 CFR ASO AL D Dothan, AL [Amended] [FR Doc. 2018–20224 Filed 9–19–18; 8:45 am] 71.1. The Class D and Class E airspace BILLING CODE 4910–13–P designations listed in this document Dothan Regional Airport, AL ° ′ ″ ° ′ ″ will be published subsequently in the (Lat. 31 19 16 N, long. 85 26 58 W) Order. That airspace extending upward from the DEPARTMENT OF TRANSPORTATION surface to and including 2,900 feet MSL Regulatory Notices and Analyses within a 4.7-mile radius of Dothan Regional Federal Aviation Administration The FAA has determined that this Airport. This Class D airspace area is proposed regulation only involves an effective during the specific dates and times 14 CFR Part 71 established in advance by a Notice to established body of technical [Docket No. FAA–2018–0682; Airspace regulations for which frequent and Airmen. The effective date and time will Docket No. 18–ACE–5] routine amendments are necessary to thereafter be continuously published in the keep them operationally current. It, Chart Supplement. RIN 2120–AA66 therefore: (1) Is not a ‘‘significant Paragraph 6002 Class E Airspace Proposed Amendment of Class E regulatory action’’ under Executive Designated as Surface Areas. Order 12866; (2) is not a ‘‘significant Airspace; Cabool, MO * * * * * rule’’ under DOT Regulatory Policies AGENCY: Federal Aviation and Procedures (44 FR 11034; February ASO AL E2 Dothan, AL [New] Administration (FAA), DOT. 26, 1979); and (3) does not warrant Dothan Regional Airport, AL ACTION: Notice of proposed rulemaking preparation of a regulatory evaluation as (Lat. 31°19′16″ N, long. 85°26′58″ W) (NPRM). the anticipated impact is so minimal. That airspace extending upward from the Since this is a routine matter that will SUMMARY: surface within a 4.7-mile radius of Dothan This action proposes to only affect air traffic procedures and air amend Class E airspace extending navigation, it is certified that this Regional Airport. This Class E surface airspace area is effective during the specific upward from 700 feet above the surface proposed rule, when promulgated, will at Cabool Memorial Airport, Cabool, not have a significant economic impact dates and times established in advance by a Notice to Airmen. The effective date and time MO. The FAA is proposing this action on a substantial number of small entities as the result of an airspace review under the criteria of the Regulatory will thereafter be continuously published in the Chart Supplement. caused by the decommissioning of the Flexibility Act. Maples VHF omnidirectional range Paragraph 6004 Class E Airspace Environmental Review (VOR) navigation aid, which provided Designated as an Extension to a Class D navigation information for the This proposal would be subject to an Surface Area. instrument procedures at this airport, as environmental analysis in accordance * * * * * part of the VOR Minimum Operational with FAA Order 1050.1F, ASO AL E4 Dothan, AL [Amended] Network (MON) Program. The ‘‘Environmental Impacts: Policies and geographic coordinates of the airport Procedures’’ prior to any FAA final Dothan Regional Airport, AL would also be updated to coincide with ° ′ ″ ° ′ ″ regulatory action. (Lat. 31 19 16 N, long. 85 26 58 W) the FAA’s aeronautical database. This Lists of Subjects in 14 CFR Part 71 Wiregrass VORTAC action is necessary for the safety and (Lat. 31°17′05″ N, long. 85°25′52″ W) Airspace, Incorporation by reference, management of instrument flight rules That airspace extending upward from the (IFR) operations at this airport. Navigation (air). surface within 3.2 miles each side of the ° DATES: Comments must be received on The Proposed Amendment Wiregrass VORTAC 156 radial, extending or before November 5, 2018. In consideration of the foregoing, the from the 4.7-mile radius of Dothan Regional Airport to 7-miles southeast of the VORTAC. ADDRESSES: Send comments on this Federal Aviation Administration proposal to the U.S. Department of proposes to amend 14 CFR part 71 as Paragraph 6005 Class E Airspace Areas Transportation, Docket Operations, 1200 follows: Extending Upward From 700 Feet or More New Jersey Avenue SE, West Building Above the Surface of the Earth. Ground Floor, Room W12–140, PART 71—DESIGNATION OF CLASS A, * * * * * Washington, DC 20590; telephone (202) B, C, D, AND E AIRSPACE AREAS; AIR 366–9826, or (800) 647–5527. You must TRAFFIC SERVICE ROUTES; AND ASO AL E5 Dothan, AL [Amended] identify FAA Docket No. FAA–2018– REPORTING POINTS Dothan Regional Airport, AL 0682; Airspace Docket No. 18–ACE–5 at (Lat. 31°19′16″ N, long. 85°26′58″ W) ■ 1. The authority citation for part 71 the beginning of your comments. You Wiregrass VORTAC may also submit comments through the continues to read as follows: ° ′ ″ ° ′ ″ (Lat. 31 17 05 N, long. 85 25 52 W) internet at http://www.regulations.gov. Authority: 49 U.S.C. 106(f), 106(g); 40103, That airspace extending upward from 700 You may review the public docket 40113, 40120; E.O. 10854, 24 FR 9565, 3 CFR, feet above the surface within a 6.7-mile 1959–1963 Comp., p. 389. containing the proposal, any comments radius of Dothan Regional Airport within 3.2 received, and any final disposition in § 71.1 [Amended] miles each side of Wiregrass VORTAC 156° person in the Dockets Office between ■ 2. The incorporation by reference in radial, extending from the 6.7-mile radius to 9:00 a.m. and 5:00 p.m., Monday 14 CFR 71.1 of Federal Aviation 7 miles SE of the VORTAC excluding that through Friday, except federal holidays. Administration Order 7400.11C, airspace within the Fort Rucker, AL, Class E FAA Order 7400.11C, Airspace Airspace Designations and Reporting airspace area. Designations and Reporting Points, and

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subsequent amendments can be viewed triplicate to the address listed above. removing the Maples VORTAC and online at http://www.faa.gov/air_traffic/ Commenters wishing the FAA to associated extension northeast of the publications/. For further information, acknowledge receipt of their comments airport. This action would also update you can contact the Airspace Policy on this notice must submit with those the geographic coordinates of the airport Group, Federal Aviation comments a self-addressed, stamped to coincide with the FAA’s aeronautical Administration, 800 Independence postcard on which the following database. Avenue SW, Washington, DC 20591; statement is made: ‘‘Comments to This action is necessary due to an telephone: (202) 267–8783. The Order is Docket No. FAA–2018–0682; Airspace airspace review caused by the also available for inspection at the Docket No. 18–ACE–5.’’ The postcard decommissioning of the Maples VOR, National Archives and Records will be date/time stamped and returned Administration (NARA). For to the commenter. which provided navigation information information on the availability of FAA All communications received before to the instrument procedures at this Order 7400.11C at NARA, call (202) the specified closing date for comments airport, as part of the VOR MON 741–6030, or go to https:// will be considered before taking action Program. www.archives.gov/federal-register/cfr/ on the proposed rule. The proposal Class E airspace designations are ibr-locations.html. contained in this notice may be changed published in paragraphs 6005 of FAA FAA Order 7400.11, Airspace in light of the comments received. A Order 7400.11C, dated August 13, 2018, Designations and Reporting Points, is report summarizing each substantive and effective September 15, 2018, which published yearly and effective on public contact with FAA personnel is incorporated by reference in 14 CFR September 15. concerned with this rulemaking will be 71.1. The Class E airspace designations FOR FURTHER INFORMATION CONTACT: filed in the docket. listed in this document will be Jeffrey Claypool, Federal Aviation Availability of NPRMs published subsequently in the Order. Administration, Operations Support An electronic copy of this document Group, Central Service Center, 10101 Regulatory Notices and Analyses may be downloaded through the Hillwood Parkway, Fort Worth, TX internet at http://www.regulations.gov. The FAA has determined that this 76177; telephone (817) 222–5711. Recently published rulemaking proposed regulation only involves an SUPPLEMENTARY INFORMATION: documents can also be accessed through established body of technical Authority for This Rulemaking the FAA’s web page at http:// regulations for which frequent and www.faa.gov/air_traffic/publications/ routine amendments are necessary to The FAA’s authority to issue rules airspace_amendments/. keep them operationally current, is non- regarding aviation safety is found in You may review the public docket controversial and unlikely to result in Title 49 of the United States Code. containing the proposal, any comments adverse or negative comments. It, Subtitle I, Section 106 describes the received, and any final disposition in therefore: (1) Is not a ‘‘significant authority of the FAA Administrator. person in the Dockets Office (see the regulatory action’’ under Executive Subtitle VII, Aviation Programs, ADDRESSES section for the address and Order 12866; (2) is not a ‘‘significant describes in more detail the scope of the phone number) between 9:00 a.m. and rule’’ under DOT Regulatory Policies agency’s authority. This rulemaking is 5:00 p.m., Monday through Friday, and Procedures (44 FR 11034; February promulgated under the authority except federal holidays. An informal 26, 1979); and (3) does not warrant described in Subtitle VII, Part A, docket may also be examined during Subpart I, Section 40103. Under that preparation of a regulatory evaluation as normal business hours at the Federal the anticipated impact is so minimal. section, the FAA is charged with Aviation Administration, Air Traffic prescribing regulations to assign the use Since this is a routine matter that will Organization, Central Service Center, only affect air traffic procedures and air of airspace necessary to ensure the Operations Support Group, 10101 safety of aircraft and the efficient use of navigation, it is certified that this Hillwood Parkway, Fort Worth, TX proposed rule, when promulgated, airspace. This regulation is within the 76177. scope of that authority as it would would not have a significant economic amend Class E airspace extending Availability and Summary of impact on a substantial number of small upward from 700 feet above the surface Documents for Incorporation by entities under the criteria of the at Cabool Memorial Airport, Cabool, Reference Regulatory Flexibility Act. MO, to support IFR operations at the This document proposes to amend Environmental Review airport. FAA Order 7400.11C, Airspace Comments Invited Designations and Reporting Points, This proposal will be subject to an dated August 13, 2018, and effective environmental analysis in accordance Interested parties are invited to September 15, 2018. FAA Order with FAA Order 1050.1F, participate in this proposed rulemaking 7400.11C is publicly available as listed ‘‘Environmental Impacts: Policies and by submitting such written data, views, in the ADDRESSES section of this Procedures’’ prior to any FAA final or arguments, as they may desire. document. FAA Order 7400.11C lists regulatory action. Comments that provide the factual basis Class A, B, C, D, and E airspace areas, supporting the views and suggestions air traffic service routes, and reporting List of Subjects in 14 CFR Part 71 presented are particularly helpful in points. developing reasoned regulatory Airspace, Incorporation by reference, decisions on the proposal. Comments The Proposal Navigation (air). are specifically invited on the overall The FAA is proposing an amendment The Proposed Amendment regulatory, aeronautical, economic, to Title 14 Code of Federal Regulations environmental, and energy-related (14 CFR) part 71 that would amend Accordingly, pursuant to the aspects of the proposal. Class E airspace extending upward from authority delegated to me, the Federal Communications should identify both 700 feet above the surface at Cabool Aviation Administration proposes to docket numbers and be submitted in Memorial Airport, Cabool, MO, by amend 14 CFR part 71 as follows:

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PART 71—DESIGNATION OF CLASS A, instrument procedures at this airport, as section, the FAA is charged with B, C, D, AND E AIRSPACE AREAS; AIR part of the VOR Minimum Operational prescribing regulations to assign the use TRAFFIC SERVICE ROUTES; AND Network (MON) Program. The of airspace necessary to ensure the REPORTING POINTS geographic coordinates of the airport safety of aircraft and the efficient use of would also be updated to coincide with airspace. This regulation is within the ■ 1. The authority citation for 14 CFR the FAA’s aeronautical database. scope of that authority as it would part 71 continues to read as follows: DATES: Comments must be received on amend Class D airspace and Class E Authority: 49 U.S.C. 106(f), 106(g); 40103, or before November 5, 2018. airspace designated as a surface area, 40113, 40120; E.O. 10854, 24 FR 9565, 3 CFR, ADDRESSES: Send comments on this and remove Class E airspace designated 1959–1963 Comp., p. 389. proposal to the U.S. Department of as an extension to a Class D and Class E airspace at Drake Field, Fayetteville, § 71.1 [Amended] Transportation, Docket Operations, West Building Ground Floor, Room AR, to support instrument flight rule ■ 2. The incorporation by reference in W12–140, 1200 New Jersey Avenue SE, operations at the airport. 14 CFR 71.1 of FAA Order 7400.11C, Washington, DC 20590; telephone (202) Airspace Designations and Reporting Comments Invited 366–9826, or (800) 647–5527. You must Points, dated August 13, 2018, and Interested parties are invited to identify FAA Docket No. FAA–2018– effective September 15, 2018, is participate in this proposed rulemaking 0699; Airspace Docket No. 18–ASW–11, amended as follows: by submitting such written data, views, at the beginning of your comments. You or arguments, as they may desire. Paragraph 6005 Class E Airspace Areas may also submit comments through the Comments that provide the factual basis Extending Upward From 700 Feet or More internet at http://www.regulations.gov. Above the Surface of the Earth. supporting the views and suggestions You may review the public docket presented are particularly helpful in * * * * * containing the proposal, any comments developing reasoned regulatory ACE MO E5 Cabool, MO [Amended] received, and any final disposition in decisions on the proposal. Comments person in the Dockets Office between are specifically invited on the overall Cabool Memorial Airport, MO 9:00 a.m. and 5:00 p.m., Monday (Lat. 37°07′57″ N, long. 92°05′02″ W) regulatory, aeronautical, economic, through Friday, except Federal holidays. environmental, and energy-related That airspace extending upward from 700 FAA Order 7400.11C, Airspace feet above the surface within a 6.3-mile aspects of the proposal. radius of Cabool Memorial Airport. Designations and Reporting Points, and Communications should identify both subsequent amendments can be viewed _ docket numbers and be submitted in Issued in Fort Worth, Texas, on September online at http://www.faa.gov/air traffic/ triplicate to the address listed above. 10, 2018. publications/. For further information, Commenters wishing the FAA to Walter Tweedy, you can contact the Airspace Policy acknowledge receipt of their comments Acting Manager, Operations Support Group, Group, Federal Aviation on this notice must submit with those ATO Central Service Center. Administration, 800 Independence comments a self-addressed, stamped [FR Doc. 2018–20398 Filed 9–19–18; 8:45 am] Avenue SW, Washington, DC 20591; postcard on which the following BILLING CODE 4910–13–P telephone: (202) 267–8783. The Order is statement is made: ‘‘Comments to also available for inspection at the Docket No. FAA–2018–0699/Airspace National Archives and Records Docket No. 18–ASW–11.’’ The postcard DEPARTMENT OF TRANSPORTATION Administration (NARA). For will be date/time stamped and returned information on the availability of FAA to the commenter. Federal Aviation Administration Order 7400.11C at NARA, call (202) All communications received before 741–6030, or go to http:// the specified closing date for comments 14 CFR Part 71 www.archives.gov/federal-register/cfr/ will be considered before taking action [Docket No. FAA–2018–0699; Airspace ibr-locations.html. on the proposed rule. The proposal Docket No. 18–ASW–11] FAA Order 7400.11, Airspace contained in this notice may be changed Designations and Reporting Points, is RIN 2120–AA66 in light of the comments received. A published yearly and effective on report summarizing each substantive September 15. Proposed Amendment of Class D and public contact with FAA personnel E Airspace and Revocation of Class E FOR FURTHER INFORMATION CONTACT: concerned with this rulemaking will be Airspace; Fayetteville, AR Jeffrey Claypool, Federal Aviation filed in the docket. Administration, Operations Support AGENCY: Federal Aviation Group, Central Service Center, 10101 Availability of NPRMs Administration (FAA), DOT. Hillwood Parkway, Fort Worth, TX An electronic copy of this document ACTION: Notice of proposed rulemaking 76177; telephone (817) 222–5711. may be downloaded through the (NPRM). SUPPLEMENTARY INFORMATION: internet at http://www.regulations.gov. Recently published rulemaking SUMMARY: This action proposes to Authority for This Rulemaking documents can also be accessed through amend Class D airspace and Class E The FAA’s authority to issue rules the FAA’s web page at http:// airspace designated as a surface area, regarding aviation safety is found in www.faa.gov/air_traffic/publications/ and remove Class E airspace designated Title 49 of the United States Code. airspace_amendments/. as an extension to a Class D and Class Subtitle I, Section 106 describes the You may review the public docket E airspace at Drake Field, Fayetteville, authority of the FAA Administrator. containing the proposal, any comments AR. The FAA is proposing this action as Subtitle VII, Aviation Programs, received, and any final disposition in the result of an airspace review caused describes in more detail the scope of the person in the Dockets Office (see the by the decommissioning of the Drake agency’s authority. This rulemaking is ADDRESSES section for the address and VHF omnidirectional range (VOR) promulgated under the authority phone number) between 9:00 a.m. and navigation aid, which provided described in Subtitle VII, Part A, 5:00 p.m., Monday through Friday, navigation information for the Subpart I, Section 40103. Under that except federal holidays. An informal

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docket may also be examined during 4.0-mile radius to 4.9 miles north of the List of Subjects in 14 CFR Part 71 normal business hours at the Federal airport. The city associated with the Airspace, Incorporation by reference, Aviation Administration, Air Traffic airport would be removed from the Navigation (air). Organization, Central Service Center, airspace legal description to comply Operations Support Group, 10101 with a change to FAA Order 7400.2L, The Proposed Amendment Hillwood Parkway, Fort Worth, TX Procedures for Handling Airspace Accordingly, pursuant to the 76177. Matters, and the outdated term authority delegated to me, the Federal Availability and Summary of ‘‘Airport/Facility Directory’’ would be Aviation Administration proposes to Documents for Incorporation by updated to ‘‘Chart Supplement.’’ amend 14 CFR part 71 as follows: Reference Additionally, the geographic coordinates of the airport would be PART 71—DESIGNATION OF CLASS A, This document proposes to amend updated to coincide with the FAA’s B, C, D, AND E AIRSPACE AREAS; AIR FAA Order 7400.11C, Airspace aeronautical database. TRAFFIC SERVICE ROUTES; AND Designations and Reporting Points, REPORTING POINTS dated August 13, 2018, and effective And removing the Class E airspace designated as an extension to Class D September 15, 2018. FAA Order ■ 1. The authority citation for 14 CFR and Class E at Drake Field as it is no 7400.11C is publicly available as listed part 71 continues to read as follows: in the ADDRESSES section of this longer required. This action as the result of an airspace Authority: 49 U.S.C. 106(f), 106(g); 40103, document. FAA Order 7400.11C lists 40113, 40120; E.O. 10854, 24 FR 9565, 3 CFR, Class A, B, C, D, and E airspace areas, review caused by the decommissioning 1959–1963 Comp., p. 389. air traffic service routes, and reporting of the Drake VOR, which provided points. navigation information for the § 71.1 [Amended] instrument procedures at this airport, as ■ The Proposal 2. The incorporation by reference in part of the VOR MON Program. 14 CFR 71.1 of FAA Order 7400.11C, The FAA is proposing an amendment Class D and E airspace designations Airspace Designations and Reporting to Title 14 Code of Federal Regulations are published in paragraph 5000, 6002, Points, dated August 13, 2018, and (14 CFR) part 71 by: and 6004, respectively, of FAA Order effective September 15, 2018, is Amending the Class D airspace at 7400.11C, dated August 13, 2018, and amended as follows: Drake Field, Fayetteville, AR, to within effective September 15, 2018, which is a 4.0-mile radius (decreased from a 4.1- Paragraph 5000 Class D Airspace. incorporated by reference in 14 CFR mile radius); and adding an extension * * * * * ° 71.1. The Class D and E airspace 1.1 miles each side of the 181 bearing ASW AR D Fayetteville, AR [Amended] from the airport from the 4.0-mile radius designations listed in this document to 5.9 miles north of the airport, and will be published subsequently in the Drake Field, AR (Lat. 36°00′18″ N, long. 94°10′12″ W) adding an extension 1.0 mile each side Order. ° Drake Field: RWY 34–LOC of the 172 bearing from the Drake Field: Regulatory Notices and Analyses (Lat. 36°00′26″ N, long. 94°10′10″ W) RWY 34–LOC from the 4.0-mile radius That airspace extending upward from the to 4.9 miles south of the Drake Field: The FAA has determined that this regulation only involves an established surface to and including 3,800 feet MSL RWY 34–LOC; and adding an extension within a 4.0-mile radius of Drake Field, and 1.0 mile each side of the 347° bearing body of technical regulations for which within 1.1 miles each side of the 181° bearing from the airport from the 4.0-mile radius frequent and routine amendments are from the airport from the 4.0-mile radius to to 4.9 miles north the airport. The city necessary to keep them operationally 5.9 miles south of the airport, and within 1.0 associated with the airport would be current, is non-controversial and mile each sided of the 172° bearing from the removed from the airspace legal unlikely to result in adverse or negative Drake Field: RWY 34–LOC from the 4.0-mile description to comply with a change to comments. It, therefore: (1) Is not a radius to 4.9 miles south of the Drake Field: ‘‘significant regulatory action’’ under RWY 34–LOC, and within 1.0 mile each side FAA Order 7400.2L, Procedures for of the 347° bearing from the airport from the Handling Airspace Matters, and the Executive Order 12866; (2) is not a ‘‘significant rule’’ under DOT 4.0-mile radius to 4.9 miles north of the outdated term ‘‘Airport/Facility airport. This Class D airspace area is effective Directory’’ would be updated to ‘‘Chart Regulatory Policies and Procedures (44 during the specific dates and times Supplement.’’ Additionally, the FR 11034; February 26, 1979); and (3) established in advance by a Notice to geographic coordinates of the airport does not warrant preparation of a Airmen. The effective date and time will would be updated to coincide with the regulatory evaluation as the anticipated thereafter be continuously published in the FAA’s aeronautical database. impact is so minimal. Since this is a Chart Supplement. Amending the Class E airspace routine matter that will only affect air Paragraph 6002 Class E Airspace Areas designated as a surface area at Drake traffic procedures and air navigation, it Designated as Surface Areas. is certified that this rule, when Field to within a 4.0-mile radius * * * * * (decreased from a 4.1-mile radius); and promulgated, would not have a extending the airspace up to and significant economic impact on a ASW AR E2 Fayetteville, AR [Amended] including 3,800 feet MSL; and adding substantial number of small entities Drake Field, AR an extension 1.1 miles each side of the under the criteria of the Regulatory (Lat. 36°00′18″ N, long. 94°10′12″ W) 181° bearing from the airport from the Flexibility Act. Drake Field: RWY 34–LOC (Lat. 36°00′26″ N, long. 94°10′10″ W) 4.0-mile radius to 5.9 miles south of the Environmental Review airport, and adding an extension 1.0 That airspace extending upward from the mile each side of the 172° bearing from This proposal will be subject to an surface to and including 3,800 feet MSL within a 4.0-mile radius of Drake Field, and the Drake Field: RWY 34–LOC from the environmental analysis in accordance within 1.1 miles each side of the 181° bearing 4.0-mile radius to 4.9 miles south of the with FAA Order 1050.1F, from the airport from the 4.0-mile radius to Drake Field: RWY 34–LOC; and adding ‘‘Environmental Impacts: Policies and 5.9 miles south of the airport, and within 1.0 an extension 1.0 mile each side of the Procedures’’ prior to any FAA final mile each sided of the 172° bearing from the 347° bearing from the airport from the regulatory action. Drake Field: RWY 34–LOC from the 4.0-mile

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radius to 4.9 miles south of the Drake Field: ‘‘NPS’’ and must include the docket but the cooler months, October to May, RWY 34–LOC, and within 1.0 mile each side number or RIN (1024–AE48) for this receive the highest use; holidays are ° of the 347 bearing from the airport from the rulemaking. Comments received may be times of especially heavy use. The 4.0-mile radius to 4.9 miles north of the posted without change to http:// Lower Spring area is the most airport. This Class E airspace area is effective developed and includes the following during the specific dates and times www.regulations.gov, including any personal information provided. features: Cool Pool, Sunrise Pool, established in advance by a Notice to • Airmen. The effective date and time will Docket: For access to the docket to Crystal Pool, Children’s Play Tub, thereafter be continuously published in the read background documents or communal fire pit, library, shower, Chart Supplement. comments received, go to http:// bathtub, sink for dishwashing, www.regulations.gov. maintained lawn, settling pond, auto Paragraph 6004 Class E Airspace Designated as an Extension of Class D and FOR FURTHER INFORMATION CONTACT: shop, and the camp host site. It is the Class E Surface Areas. Kelly Daigle, National Park Service, site of many communal activities, such as group fires, communal dinners, and * * * * * Environmental Quality Division, (303) 987–6897, [email protected]. singing. The site contains heavy burro ASW OK E4 Fayetteville, AR [Removed] concentration and use, and invasive SUPPLEMENTARY INFORMATION: species such as palm trees and Bermuda Issued in Fort Worth, Texas, on September grass. 10, 2018. Background Walter Tweedy, Saline Valley is a large desert valley Chicken Strip Airstrip Acting Manager, Operations Support Group, located in the northwest portion of There is a small, unimproved landing ATO Central Service Center. Death Valley National Park (the park). strip to the west of Lower Spring, [FR Doc. 2018–20400 Filed 9–19–18; 8:45 am] The Saline Valley Warm Springs area is referred to as the Chicken Strip. The BILLING CODE 4910–13–P approximately 1,100 acres of formal name of the airstrip is the Saline backcountry surrounded by wilderness. Valley Warm Springs Airfield. The This area is distinctive, both in the airstrip is located at latitude N DEPARTMENT OF THE INTERIOR setting of the site and in its geology. 36°48.41″, longitude W 117°46.90″. In Saline Valley is a closed basin, which past years, there were up to three National Park Service means that the water does not flow to landing strips for small planes in this another body of water. Water in closed area. The Suicide Strip and the 36 CFR Part 7 basins only leaves the system by Crosswinds Strip have been evaporation or diversion. The Saline decommissioned. Historically, the [NPS–DEVA–25759; PPWONRADE2, Valley Warm Springs are among the PMP00EI05.YP0000] landing strips were used by miners and highest-flow springs in the park. The prospectors to access Saline Valley. The RIN 1024–AE48 mountain ranges surrounding this Chicken Strip is the only remaining valley, Saline Range, Last Chance active landing strip within the Saline Special Regulations, Areas of the Range, and Inyo Range, have elevations Valley Warm Springs area. It is National Park System, Death Valley ranging from 7,000 feet to over 11,000 approximately 1,400 feet long and 35 National Park; Designation of Airstrip feet, which result in spectacular views feet wide. The strip has a tie-down area AGENCY: National Park Service, Interior. from the Saline Valley Warm Springs. large enough to accommodate five small The Timbisha Shoshone Tribe (the planes. Features of the airstrip include ACTION: Proposed rule. Tribe), whose homelands encompass the a windsock, painted rocks lining the SUMMARY: The National Park Service entirety of the park, has a deep affinity strip, and two airplane tie-downs. proposes to revise the special for the Saline Valley Warm Springs area Visitors who fly into the Saline Valley regulations for Death Valley National due to the existence of long-lived Warm Springs area via the Chicken Park to designate the Saline Valley historical and ethnographic Strip often camp next to their airplanes. Warm Springs Airfield, commonly connections. The Timbisha Shoshone The Chicken Strip surface is known as the Chicken Strip, within the Homeland Act of 2000 (Homeland Act; maintained by the community of Saline Valley Warm Springs area as a Pub. L. 106–423) specified designated recreational pilots who use it. The location available for the operation of special use areas. Saline Valley is part Recreational Aviation Foundation aircraft. of one of these special use areas. The (RAF), an organization of private pilots, waters of the warm springs in Saline is active in the promotion of the DATES: Comments on the proposed rule Valley are a source of puha for the continued use of the Chicken Strip. In must be received by 11:59 p.m. EDT on Tribe, a life force energy. Although the 2017, the NPS renewed a memorandum November 19, 2018. development of the area by Euro- of understanding (MOU) with the RAF ADDRESSES: You may submit comments, Americans degraded puha and other that allows the RAF to maintain the identified by Regulation Identifier ethnographic resources, Tribal leaders Chicken Strip at no cost to the NPS. Number (RIN) 1024–AE48, by either of still seek these cultural connections Maintenance activities include leveling the following methods: from historic times until the present and the surface, removing stones and debris, • Federal eRulemaking Portal: http:// will continue to do so in the future. and packing the surface. www.regulations.gov. Follow the The Saline Valley Warm Springs area Based on visitor registration logs at instructions for submitting comments. has not been formally or systematically the Chicken Strip, approximately 440 • Mail to: Death Valley National Park, developed for use by the NPS but does people visited Saline Valley via airplane P.O. Box 579, Death Valley, CA 92328, have a number of user-developed and from 2008 to 2012, averaging 88 visitors Attention: Superintendent. user-maintained structures and per year. Of the aircraft reported, • Instructions: Comments will not be facilities. Visitors enjoy backcountry approximately two-thirds were Cessna accepted by fax, email, or in any way camping and soaking tubs created by models. Other types of planes included other than those specified above. All diverting water from natural source various models of Pipers, Maules, and submissions received must include the springs. Visitors use the Saline Valley Beechcraft. The largest number of words ‘‘National Park Service’’ or Warm Springs area throughout the year people recorded in one aircraft was six.

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The Chicken Strip is the last and freedom of choice for the public unique effect on State, local or tribal backcountry airstrip remaining in the where these approaches are relevant, governments or the private sector. It park and provides a unique and feasible, and consistent with regulatory addresses public use of national park challenging aviation experience. objectives. Executive Order 13563 lands, and imposes no requirements on Retaining use of the airstrip would emphasizes further that regulations other agencies or governments. A benefit visitor use and experience for must be based on the best available statement containing the information those visitors who seek this type of science and that the rulemaking process required by the Unfunded Mandates recreation or those visitors who enjoy must allow for public participation and Reform Act is not required. watching the aircraft fly into the Warm an open exchange of ideas. The NPS has Takings (Executive Order 12630) Springs area. For some visitors with developed this rule in a manner injuries or disabilities and who have consistent with these requirements. This rule does not effect a taking of access to small planes, the Chicken private property or otherwise have Reducing Regulation and Controlling Strip airstrip is the only way they can takings implications under Executive Regulatory Costs (Executive Order access the Warm Springs area because Order 12630. A takings implication 13771) the drive is too long and harsh for them. assessment is not required. Enabling regulations are considered Federalism (Executive Order 13132) Proposed Rule deregulatory under guidance This rule would designate the implementing E.O. 13771 (M–17–21). Under the criteria in section 1 of Chicken Strip airstrip as available for This rule authorizes the Superintendent Executive Order 13132, the rule does use by aircraft. This action would to allow a recreational activity for the not have sufficient federalism implement part of the preferred public to enjoy and experience certain implications to warrant the preparation alternative identified in the 2018 Saline areas within the National Park System of a Federalism summary impact Valley Warm Springs Draft Management that would otherwise be prohibited. statement. This proposed rule only Plan/Environmental Impact Statement affects use of federally-administered Regulatory Flexibility Act (DEIS). The airstrip has been in use lands and waters. It has no outside since before the NPS began managing This rule will not have a significant effects on other areas. A Federalism the Saline Valley Warm Springs area in economic effect on a substantial number summary impact statement is not 1994 and this rule would codify the of small entities under the Regulatory required. Flexibility Act (5 U.S.C. 601 et seq.). continued use of the airstrip. National Civil Justice Reform (Executive Order This certification is based on Park Service (NPS) regulations at 36 12988) CFR 2.17(a)(1) prohibit the operation or information in the report entitled use of an aircraft on lands or waters ‘‘Benefit-Cost and Regulatory Flexibility This rule complies with the other than at locations designated Analyses: Cost-Benefit and Regulatory requirements of Executive Order 12988. pursuant to a special regulation. Flexibility Threshold Analyses: This rule: This rule would also remove Proposed Special Regulations for (a) Meets the criteria of section 3(a) references to ‘‘Death Valley National Designation of Airstrip at Death Valley requiring that all regulations be Monument’’ and ‘‘Monument’’ in National Park’’ which is available online reviewed to eliminate errors and section 2.17 and replace them with at http://parkplanning.nps.gov/deva by ambiguity and be written to minimize references to ‘‘Death Valley National clicking on the link entitled ‘‘Saline litigation; and (b) Meets the criteria of section 3(b)(2) Park’’ and ‘‘Park’’. This reflects the Valley Warm Springs Management Plan requiring that all regulations be written abolishment of Death Valley National EIS’’ and then clicking on the link in clear language and contain clear legal Monument and the establishment of entitled ‘‘Document List.’’ standards. Death Valley National Park in 1994. 16 Small Business Regulatory Enforcement U.S.C. 410aaaa–1. Fairness Act Consultation With Indian Tribes (Executive Order 13175 and Department Compliance With Other Laws, This rule is not a major rule under 5 Policy) Executive Orders and Department U.S.C. 804(2), the Small Business Policy Regulatory Enforcement Fairness Act. The Department of the Interior strives This rule: to strengthen its government-to- Regulatory Planning and Review government relationship with Indian (Executive Orders 12866 and 13563) (a) Does not have an annual effect on the economy of $100 million or more. Tribes through a commitment to Executive Order 12866 provides that (b) Will not cause a major increase in consultation with Indian Tribes and the Office of Information and Regulatory costs or prices for consumers, recognition of their right to self- Affairs in the Office of Management and individual industries, Federal, State, or governance and tribal sovereignty. The Budget will review all significant rules. local government agencies, or NPS has evaluated this rule under the The Office of Information and geographic regions. criteria in Executive Order 13175 and Regulatory Affairs has determined that (c) Does not have significant adverse under the Department’s tribal this rule is not significant. effects on competition, employment, consultation policy and has determined Executive Order 13563 reaffirms the investment, productivity, innovation, or that tribal consultation is not required principles of Executive Order 12866 the ability of U.S. based enterprises to because the rule will not have a while calling for improvements in the compete with foreign-based enterprises. substantial direct effect on federally nation’s regulatory system to promote recognized Indian tribes, although predictability, to reduce uncertainty, Unfunded Mandates Reform Act (2 consultation under the National and to use the best, most innovative, U.S.C. 1531 et seq.) Environmental Policy Act and the and least burdensome tools for This rule does not impose an National Historic Preservation Act was achieving regulatory ends. The unfunded mandate on State, local, or completed. The NPS invited the Tribe to executive order directs agencies to tribal governments or the private sector become a cooperating agency on the consider regulatory approaches that of more than $100 million per year. The Draft Management Plan/Environmental reduce burdens and maintain flexibility rule does not have a significant or Impact Statement (DEIS) on April 3,

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2012. The NPS has since conducted the NPS revise the rule, your comments (3) Saline Valley Warm Springs formal consultation with the Tribe and should be as specific as possible. For Airfield, latitude N 36°48.41″, longitude invited their participation on issues and example, you should identify the W 117°46.90. alternatives development and internal numbers of the sections or paragraphs Andrea Travnicek, document review. In addition to formal that you find unclear, which sections or consultation, the NPS commissioned an Principal Deputy Assistant Secretary—Water sentences are too long, the sections and Science Exercising the Authority of the assessment of the eligibility of the where you feel lists or tables would be Assistant Secretary for Fish and Wildlife and Saline Valley Warm Springs area as an useful, etc. Parks. ethnographic site eligible for listing on [FR Doc. 2018–20332 Filed 9–19–18; 8:45 am] Public Participation the National Register of Historic Places BILLING CODE 4310–EJ–P under Criterion A. This assessment was submitted to the State Historic It is the policy of the Department of Preservation Office in early 2018. the Interior, whenever practicable, to afford the public an opportunity to DEPARTMENT OF TRANSPORTATION Paperwork Reduction Act participate in the rulemaking process. Federal Motor Carrier Safety This rule does not contain Accordingly, interested persons may Administration information collection requirements, submit written comments regarding this and a submission to the Office of proposed rule by one of the methods 49 CFR Part 395 Management and Budget under the listed in the ADDRESSES section of this Paperwork Reduction Act is not document. [Docket No. FMCSA–2018–0248] required. The NPS may not conduct or RIN 2126–AC19 sponsor and the public is not required Public Availability of Comments to respond to a collection of information Before including your address, phone Hours of Service unless it displays a currently valid OMB number, email address, or other AGENCY: Federal Motor Carrier Safety control number. personal identifying information in your Administration (FMCSA), DOT. National Environmental Policy Act of comment, you should be aware that ACTION: Announcement of public 1969 (NEPA) your entire comment—including your listening session. This rule is part of a larger planning personal identifying information—may be made publicly available at any time. SUMMARY: The FMCSA announces that it process for Saline Valley Warm Springs will hold a public listening session that constitutes a major Federal action List of Subjects in 36 CFR Part 7 concerning potential changes to its significantly affecting the quality of the hours-of-service (HOS) rules for truck human environment. NPS has prepared District of Columbia, National parks, drivers. On August 23, 2018, FMCSA the DEIS under the NEPA. A copy of the Reporting and Recordkeeping published an Advance Notice of DEIS can be found online at http:// requirements. Proposed Rulemaking (ANPRM) seeking parkplanning.nps.gov/deva, by clicking In consideration of the foregoing, the public comment on four specific aspects on the link entitled ‘‘Saline Valley of the HOS rules for which the Agency Warm Springs Management Plan EIS’’ National Park Service proposes to amend 36 CFR part 7 as set forth below: is considering changes: the short-haul and then clicking on the link entitled HOS limit; the HOS exception for ‘‘Document List.’’ PART 7—SPECIAL REGULATIONS, adverse driving conditions; the 30- Effects on the Energy Supply (Executive AREAS OF THE NATIONAL PARK minute rest break provision; and the Order 13211) SYSTEM sleeper berth rule to allow drivers to split their required time in the sleeper This rule is not a significant energy berth. In addition, the Agency requested ■ 1. The authority citation for part 7 action under the definition in Executive public comment on petitions for Order 13211. A Statement of Energy continues to read as follows: rulemaking from the Owner-Operator Effects in not required. Authority: 54 U.S.C. 100101, 100751, Independent Drivers Association Clarity of This Rule 320102; Sec. 7.96 also issued under DC Code (OOIDA) and TruckerNation.org 10–137 and DC Code 50–2201.07. (TruckerNation). The Agency The NPS is required by Executive encourages vendors of electronic logging Orders 12866 (section 1(b)(12)) and ■ 2. Amend § 7.26 by: devices (ELDs) to participate to address 12988 (section 3(b)(1)(B)), and 13563 ■ a. Revising the section heading. potential implementation issues should (section 1(a)), and by the Presidential ■ b. In paragraphs (a) and (d), removing changes to the HOS rules be made. The Memorandum of June 1, 1998, to write listening session is the third in a series all rules in plain language. This means the term ‘‘Death Valley National Monument’’ and adding in its place and will be held at the National that each rule the NPS publishes must: Automobile Museum in Reno, NV. The (a) Be logically organized; ‘‘Death Valley National Park’’. listening session will be webcast for the (b) Use the active voice to address ■ c. In paragraphs (b) and (c), removing benefit of those not able to attend in readers directly; the term ‘‘Monument’’ and adding in its person. The listening session will allow (c) Use common, everyday words and place ‘‘Park’’. clear language rather than jargon; interested persons to present comments, (d) Be divided into short sections and ■ d. Adding paragraph (e)(3). views, and relevant research on topics mentioned above. All comments will be sentences; and The revision and addition to read as transcribed and placed in the (e) Use lists and tables wherever follows: possible. rulemaking docket for the FMCSA’s If you feel that the NPS has not met § 7.26 Death Valley National Park. consideration. these requirements, send the NPS * * * * * DATES: The listening session will be comments by one of the methods listed Saturday, September 22, 2018, in Reno, (e) * * * in the ADDRESSES section. To better help NV.

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ADDRESSES: The September 22, 2018, material online or by fax, mail, or hand B. Viewing Comments and Documents meeting will be held at the National delivery, but please use only one of To view comments, as well as any Automobile Museum, 10 S. Lake Street, these means. FMCSA recommends that documents mentioned in this preamble Reno, NV 89501. The listening session you include your name and a mailing as being available in the docket, go to will begin at 10 a.m. (PDT) and end at address, an email address, or a phone http://www.regulations.gov. Insert the 12 noon, or earlier, if all participants number in the body of your document docket number, FMCSA–2018–0248, in wishing to express their views have so that FMCSA can contact you if there the keyword box, and click ‘‘Search.’’ done so. are questions regarding your Next, click the ‘‘Open Docket Folder’’ You may submit comments identified submission. button and choose the document to by Docket Number FMCSA-2018-0248 To submit your comment online, go to review. If you do not have access to the using any of the following methods: • http://www.regulations.gov, put the internet, you may view the docket Federal eRulemaking Portal: http:// online by visiting the Docket www.regulations.gov. Follow the online docket number, FMCSA–2018–0248, in the keyword box, and click ‘‘Search.’’ Management Facility in Room W12–140 instructions for submitting comments. on the ground floor of the DOT West • Mail: Docket Management Facility, When the new screen appears, click on the ‘‘Comment Now!’’ button and type Building, 1200 New Jersey Avenue SE, U.S. Department of Transportation, 1200 Washington, DC 20590, between 9 a.m. New Jersey Avenue SE, West Building, your comment into the text box on the following screen. Choose whether you and 5 p.m., e.t., Monday through Friday, Ground Floor, Room W12–140, except Federal holidays. Washington, DC 20590–0001. are submitting your comment as an • Hand Delivery or Courier: West individual or on behalf of a third party C. Privacy Act Building, Ground Floor, Room W12– and then submit. In accordance with 5 U.S.C. 553(c), 140, 1200 New Jersey Avenue SE, If you submit your comments by mail DOT solicits comments from the public Washington, DC, between 9 a.m. and 5 or hand delivery, submit them in an to better inform its rulemaking process. p.m., Monday through Friday, except unbound format, no larger than 81⁄2 by DOT posts these comments, without Federal holidays. 11 inches, suitable for copying and edit, including any personal information • Fax: 202–493–2251. electronic filing. If you submit the commenter provides, to • Submissions Containing comments by mail and would like to www.regulations.gov, as described in Confidential Business Information (CBI): know that they reached the facility, the system of records notice (DOT/ALL– Mr. Brian Dahlin, Chief, Regulatory please enclose a stamped, self-addressed 14 FDMS), which can be reviewed at Analysis Division, 1200 New Jersey postcard or envelope. www.dot.gov/privacy. Avenue SE, Washington, DC 20590. To avoid duplication, please use only FMCSA will consider all comments II. Background one of these four methods. See the and material received during the On August 23, 2018 (83 FR 42631), ‘‘Public Participation and Request for comment period for the ANPRM. Late FMCSA published an ANPRM Comments’’ portion of the comments will be considered to the concerning potential changes to its SUPPLEMENTARY INFORMATION section for extent practicable. hours-of-service rules. The ANPRM instructions on submitting comments, Confidential Business Information indicated the Agency is considering including collection of information changes in four areas of the HOS rules: comments for the Office of Information Confidential Business Information The short-haul HOS limit [49 CFR and Regulatory Affairs, OMB. (CBI) is commercial or financial 395.1(e)(1)(ii)(A)]; the HOS exception FOR FURTHER INFORMATION CONTACT: For information that is customarily not for adverse driving conditions special accommodations for the HOS made available to the public by the [§ 395.1(b)(1)]; the 30-minute rest break listening session, such as sign language submitter. Under the Freedom of provision [§ 395.3(a)(3)(ii)]; and the interpretation, contact Mr. William Information Act, CBI is eligible for sleeper berth rule to allow drivers to Cunnane, Program Specialist, at (202) protection from public disclosure. If you split their required time in the sleeper 366–0055 or [email protected], have CBI that is relevant or responsive berth [§ 395.1(g)(1)(i)(A) and (ii)(A)]. In by Monday, September 17, 2018, to to the ANPRM and this listening addition, the Agency requested public allow us to arrange for such services. session, it is important that you clearly comment on petitions for rulemaking There is no guarantee that interpreter designate the submitted comments as from the Owner-Operator Independent services requested on short notice can CBI. Accordingly, please mark each Drivers Association (OOIDA) and be provided. For information page of your submission as TruckerNation.org (TruckerNation). The concerning the HOS rules, contact Mr. ‘‘confidential’’ or ‘‘CBI.’’ Submissions ANPRM provides an opportunity for Tom Yager, Chief, Driver and Carrier designated as CBI and meeting the additional discussion of each of these Operations Division, (202) 366–4325, definition noted above will not be topics. The listening session will [email protected]. placed in the public docket for the provide interested persons to share their SUPPLEMENTARY INFORMATION: ANPRM and this listening session. views on these topics with Submissions containing CBI should be representatives of the Agency. The I. Public Participation and Request for sent to Mr. Brian Dahlin, Chief, Agency encourages ELD vendors to Comments Regulatory Analysis Division, 1200 New participate to address potential implementation issues should changes A. Submitting Comments Jersey Avenue SE, Washington, DC to the HOS rules be made. If you submit a comment, please 20590 or [email protected]. Any include the docket number for this commentary that FMCSA receives III. Meeting Participation ANPRM (Docket No. FMCSA–2018- which is not specifically designated as The listening session is open to the 0248), indicate the specific section of CBI will be placed in the public docket public. Speakers’ remarks will be this document to which each section for this rulemaking. limited to 2 minutes each. The public applies, and provide a reason for each FMCSA will consider all comments may submit material to the FMCSA staff suggestion or recommendation. You and material received during the at the session for inclusion in the public may submit your comments and comment period for the ANPRM. docket, FMCSA–2018–0248. The

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session will be webcast in its entirety, ADDRESSES: You may submit comments contact you if it has questions regarding providing the opportunity for remote identified by Docket Number FMCSA– your submission. participation via the internet. For 2018–0248 using any one of the To submit your comment online, go to information on participating in the live following methods: http://www.regulations.gov and enter webcast, please go to Federal Rulemaking Portal: either docket number, ‘‘FMCSA–2018– www.fmcsa.dot.gov. www.regulations.gov. Follow the online 0284’’ in the ‘‘Keyword’’ box, and click instructions for submitting comments. ‘‘Search.’’ When the new screen IV. Questions for Discussion During the Mail: Docket Management Facility, appears, click on ‘‘Comment Now!’’ Listening Session U.S. Department of Transportation, 1200 button and type your comment into the In preparing their comments, meeting New Jersey Avenue SE, West Building text box in the following screen. Choose participants should consider the Ground Floor, Room W12–140, whether you are submitting your questions posed in the ANPRM about Washington, DC 20590–0001. comment as an individual or on behalf the current HOS requirements. Answers Fax: 202–493–2251. of a third party and then submit. If you to these questions should be based upon Hand Delivery or Courier: Docket submit your comments by mail or hand the experience of the participants and Management Facility, U.S. Department delivery, submit them in an unbound any data or information they can share of Transportation, 1200 New Jersey format, no larger than 81⁄2 by 11 inches, with FMCSA. Avenue SE, West Building Ground suitable for copying and electronic filing. If you submit comments by mail Issued on: September 14, 2018. Floor, Room W12–140, Washington, DC 20590–0001, between 9 a.m. and 5 p.m., and would like to know that they Cathy F. Gautreaux, reached the facility, please enclose a Deputy Administrator. Monday through Friday, except Federal holidays. stamped, self-addressed postcard or [FR Doc. 2018–20427 Filed 9–19–18; 8:45 am] Submissions Containing Confidential envelope. BILLING CODE 4910–EX–P Business Information (CBI): Mr. Brian FMCSA will consider all comments Dahlin, Chief, Regulatory Evaluation and material received during the comment period and may change this DEPARTMENT OF TRANSPORTATION Division, 1200 New Jersey Ave. SE, Washington, DC 20590. proposed rule based on your comments. To avoid duplication, please use only Late comments will be considered to the Federal Motor Carrier Safety extent practicable. Administration one of these four methods. See the ‘‘Public Participation and Request for Confidential Business Information 49 CFR Part 395 Comments’’ heading under the Confidential Business Information SUPPLEMENTARY INFORMATION section [Docket No. FMCSA–2018–0248] (CBI) is commercial or financial below for instructions regarding information that is customarily not submitting comments. RIN 2126–AC19 made available to the general public by FOR FURTHER INFORMATION CONTACT: Mr. the submitted. Under the Freedom of Hours of Service of Drivers Tom Yager, Chief, Driver and Carrier Information Act, CBI is eligible for Operations Division, Federal Motor protection from public disclosure. If you ACTION: Advance notice of proposed Carrier Safety Administration, U.S. have CVI that is relevant or responsive rulemaking (ANPRM); Extension of Department of Transportation, 1200 to this notice, it is important that you comment period. New Jersey Avenue SE, Washington, DC clearly designate the submitted 20590, at (202) 366–4325, or via email: comments as CBI. Accordingly, please SUMMARY: The Federal Motor Carrier [email protected]. Safety Administration (FMCSA) extends mark each page of your submission as If you have questions on viewing or ‘‘confidential’’ or ‘‘CBI.’’ Submissions the comment period for its August 23, submitting material to the docket, 2018, ANPRM concerning hours of designated as CBI and meeting the contact Docket Services, telephone (202) definition noted above will not be service for drivers of property-carrying 366–9826. commercial motor vehicles (CMVs). placed in the public docket. FMCSA received requests for an SUPPLEMENTARY INFORMATION: Submissions containing CBI should be sent to Brian Dahlin, Chief, Regulatory extension to the comment period from Public Participation and Request for Evaluation Division, 1200 New Jersey a number of organizations, including the Comments American Trucking Association, the Ave. SE, Washington, DC 20590. Any FMCSA encourages you to participate Commercial Vehicle Safety Alliance, the commentary that FMCSA receives by submitting comments and related International Brotherhood of Teamsters, which is not specifically designated as materials. the National Pork Producers Council, CBI will be placed in the public docket and the National Tank Truck Carriers, Submitting Comments for this rulemaking. Inc. The Agency believes it is If you submit a comment, please Viewing Comments and Documents appropriate to extend the comment include the docket number for this To view comments, as well as period to provide interested parties notice (FMCSA–2018–0284), indicate documents available in the docket, go to additional time to submit their the specific section of this document to http://www.regulations.gov and insert responses to the ANPRM. Therefore, the which each comment applies, and the docket number, ‘‘FMCSA–2018– Agency extends the deadline for the provide a reason for each suggestion or 0248’’ in the ‘‘Keyword’’ box and click submission of comments from recommendation. You may submit your ‘‘Search.’’ Next, click ‘‘Open Docket September 24, 2018, to October 10, comments and material online or by fax, Folder’’ button and choose the 2018. mail, or hand delivery, but please use document listed to review. If you do not DATES: The comment period for the only one of these means. FMCSA have access to the internet, you may ANPRM published August 23, 2018 at recommends that you include your view the docket online by visiting the 83 FR 42631 is extended. Comments on name and a mailing address, an email Docket Management Facility in Room the ANPRM must be received on or address, or a phone number in the body W12–140 on the ground floor of the before October 10, 2018. of your document so the Agency can DOT West Building, 1200 New Jersey

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Avenue SE, Washington, DC 20590, DEPARTMENT OF COMMERCE • Electronic Submissions: Submit all between 9 a.m. and 5 p.m., ET, Monday electronic public comments via the through Friday, except Federal holidays. National Oceanic and Atmospheric Federal eRulemaking Portal. Go to Administration www.regulations.gov/ Privacy Act #!docketDetail;D=NOAA-NMFS-2018- 50 CFR Parts 223 and 224 Under 5 U.S.C. 553(c), DOT solicits 0060. Click the ‘‘Comment Now’’ icon, comments from the public to better [Docket No. 180503449–8782–01] complete the required fields, and enter inform its potential rulemaking process. or attach your comments. RIN 0648–XG232 • DOT posts these comments, without Mail: Submit written comments to Lance Smith, NOAA IRC, NMFS/PIRO/ edit, including any personal information Endangered and Threatened Wildlife; PRD, 1845 Wasp Blvd., Bldg. 176, the commenter provides, to Positive 90-Day Finding on a Petition Honolulu, HI 96818. www.regulations.gov, as described in To List the Cauliflower Coral, Instructions: Comments sent by any the system of records notice (DOT/ALL– Pocillopora Meandrina, in Hawaii as other method, to any other address or 14 FDMS), which can be reviewed at Endangered or Threatened Under the individual, or received after the end of www.dot.gov/privacy. Endangered Species Act the comment period, may not be Background AGENCY: National Marine Fisheries considered by NMFS. All comments Service (NMFS), National Oceanic and received are a part of the public record The August 23, 2018 ANPRM (83 FR Atmospheric Administration (NOAA), and will generally be posted for public 42631) asked for public comment on Department of Commerce. viewing on www.regulations.gov four subject areas: Short haul ACTION: 90-day petition finding, request without change. All personal identifying operations, adverse conditions, the 30- for information, and initiation of status information (e.g., name, address, etc.), minute break, and the split-sleeper berth review. confidential business information, or provision. The ANPRM also sought otherwise sensitive information public comment on two petitions for SUMMARY: We, NMFS, announce a 90- submitted voluntarily by the sender will rulemaking from the Owner-Operator day finding on a petition to list the be publicly accessible. NMFS will Independent Drivers Association cauliflower coral (Pocillopora accept anonymous comments (enter (OOIDA) and TruckerNation. meandrina) in Hawaii as an endangered ‘‘N/A’’ in the required fields if you wish FMCSA held a public listening or threatened species under the to remain anonymous). session on August 24, 2018, at the Great Endangered Species Act (ESA). The Copies of the petition and related American Truck Show, in Dallas, Texas petition requested that the Hawaii materials are available on our website at (83 FR 42630). population of P. meandrina be http://www.fisheries.noaa.gov/species/ considered a significant portion of the Pocillopora-meandrina. Extension of the Public Comment range of the species, and that the species FOR FURTHER INFORMATION CONTACT: Period be listed because of its status in Hawaii. Lance Smith, NMFS, Pacific Islands Our policy on the interpretation of the The comment period for the ANPRM Regional Office, Protected Resources phrase ‘‘Significant Portion of Its was set to expire on September 24, 2018 Division, (808) 725–5131; or Chelsey Range’’ (SPR) under the ESA states that, (83 FR 42631). FMCSA received several Young, NMFS, Office of Protected before undergoing an SPR analysis, we Resources, 301–427–8403. requests to extend the comment period, must first find that the species is neither SUPPLEMENTARY INFORMATION: as noted above. Copies of the requests endangered nor threatened throughout are included in the docket referenced at all of its range. Therefore, we interpret Background the beginning of this notice. the petition as a request to consider the On March 14, 2018, we received a The organizations requested various status of P. meandrina throughout its petition from the Center for Biological lengths of time for the extension ranging range first. We find that the petition and Diversity to list the cauliflower coral from 30 to 60 days, stating that the other readily available information in (Pocillopora meandrina) in Hawaii as an additional time was needed to enable our files indicates that P. meandrina endangered or threatened species under them to prepare more comprehensive may warrant listing as a threatened the ESA. The petition asserts that P. responses based on research and species or an endangered species meandrina in Hawaii is threatened by at information that has only recently been throughout its range. Thus, we will least four of the five ESA section 4(a)(1) released or is expected to be released at initiate a global status review of P. factors: (1) Pesent modification of its upcoming industry meetings. meandrina to determine whether listing habitat; (2) disease and predation; (3) FMCSA has determined that it throughout its range is warranted. If inadequacy of existing regulatory extending the comment period would not, we will determine if Hawaii mechanisms: and (4) other natural or provide the organizations additional constitutes an SPR, and proceed manmade factors, specifically ocean time to prepare more detailed comments accordingly. To ensure that the status warming and ocean acidification that are reflective of the concerns of review is comprehensive, we are resulting from global climate change. their members. Accordingly, FMCSA soliciting scientific and commercial Copies of the petition are available upon extends the comment period for all information pertaining to P. meandrina request (see ADDRESSES). comments on the ANPRM to October 10, from any interested party. 2018. DATES: Information and comments on ESA Statutory, Regulatory, and Policy the subject action must be received by Provisions and Evaluation Framework Issued under the authority of delegations November 19, 2018. in 49 CFR 1.87: September 14, 2018. Section 4(b)(3)(A) of the ESA of 1973, ADDRESSES: You may submit comments, as amended (16 U.S.C. 1531 et seq.), Cathy F. Gautreaux, information, or data on this document, requires, to the maximum extent Deputy Administrator. identified by the code NOAA–NMFS– practicable, that within 90 days of [FR Doc. 2018–20430 Filed 9–19–18; 8:45 am] 2018–0060, by either of the following receipt of a petition to list a species as BILLING CODE 4910–EX–P methods: threatened or endangered, the Secretary

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of Commerce make a finding on whether species, any distinct population reliable and a reasonable person would that petition presents substantial segment (DPS) that interbreeds when conclude it supports the petitioners’ scientific or commercial information mature (16 U.S.C. 1532(16)). Because P. assertions. In other words, conclusive indicating that the petitioned action meandrina is an invertebrate, it cannot information indicating the species may may be warranted, and promptly qualify as a DPS. Under the ESA, a meet the ESA’s requirements for listing publish such finding in the Federal species is ‘‘endangered’’ if it is in danger is not required to make a positive 90- Register (16 U.S.C. 1533(b)(3)(A)). When of extinction throughout all or a day finding. We will not conclude that it is found that substantial scientific or significant portion of its range, or a lack of specific information alone commercial information in a petition ‘‘threatened’’ if it is likely to become negates a positive 90-day finding if a indicates the petitioned action may be endangered within the foreseeable reasonable person would conclude that warranted (a ‘‘positive 90-day finding’’), future throughout all or a significant the unknown information itself suggests we are required to commence a portion of its range (ESA sections 3(6) an extinction risk of concern for the comprehensive review of the status of and 3(20), respectively, 16 U.S.C. species at issue. See 50 CFR 424.14 for the species concerned using the best 1532(6) and (20)). The petition requests regulations on petitions under the ESA. available scientific and commercial that the Hawaii portion of the species’ Our determination as to whether the information, which we will conclude range be considered a significant petition provides substantial scientific with a finding as to whether, in fact, the portion of its range, thus the petition or commercial information indicating petitioned action is warranted. This focuses primarily on the status of P. that the petitioned action may be finding is due within 12 months of meandrina in Hawaii. However, the warranted depends in part on the degree receipt of the petition. Because the petition also requests that P. meandrina to which the petition includes the finding at the 12-month stage is based be listed throughout its range, and following types of information: (1) on a more thorough review of the provides some information on its status Information on current population available information, compared to the and threats outside of Hawaii. Our status and trends and estimates of narrow scope of review at the 90-day policy on the interpretation of the current population sizes and stage, a ‘‘may be warranted’’ 90-day phrase ‘‘significant portion of its range’’ distributions, both in captivity and the finding does not prejudge the outcome (SPR) under the ESA (79 FR 37577, July wild, if available; (2) identification of of the 12-month finding. 1, 2014) states that, before undergoing the factors under section 4(a)(1) of the ESA-implementing regulations issued an analysis of SPR, we must first find ESA that may affect the species and jointly by NMFS and USFWS (50 CFR that the species is neither endangered where these factors are acting upon the 424.14(h)(1)(i)) define ‘‘substantial nor threatened throughout all of its species; (3) whether and to what extent scientific or commercial information’’ in range. Therefore, we interpret the any or all of the factors alone or in the context of reviewing a petition to petition as a request to consider the combination identified in section 4(a)(1) list, delist, or reclassify a species as status of P. meandrina throughout its of the ESA may cause the species to be credible scientific or commercial range first; and if appropriate, an endangered species or threatened information in support of the petition’s subsequently consider whether P. species (i.e., the species is currently in claims such that a reasonable person meandrina in Hawaii constitutes an SPR danger of extinction or is likely to conducting an impartial scientific and the status of that SPR. become so within the foreseeable review would conclude that the action future), and, if so, how high in proposed in the petition may be At the 90-day finding stage, we magnitude and how imminent the warranted. Conclusions drawn in the evaluate the petitioners’ request based threats to the species and its habitat are; petition without the support of credible upon the information in the petition (4) information on adequacy of scientific or commercial information including its references and the regulatory protections and effectiveness will not be considered ‘‘substantial information readily available in our of conservation activities by States as information.’’ In evaluating whether files. We do not conduct additional well as other parties, that have been substantial information is contained in research, and we do not solicit initiated or that are ongoing, that may the petition, we consider whether the information from parties outside the protect the species or its habitat; and (5) petition (1) Clearly indicates the agency to help us in evaluating the a complete, balanced representation of administrative measure recommended petition. We are not required to consider the relevant facts, including information and gives the scientific and any any supporting materials cited by the that may contradict claims in the common name of the species involved; petitioner if the petitioner does not petition. See 50 CFR 424.14(d). (2) contains a detailed narrative provide electronic or hard copies, to the The factors under section 4(a)(1) of justification for the recommended extent permitted by U.S. copyright law, the ESA that may affect the species are measure, describing, based on available or appropriate excerpts or quotations as follows: (1) The present or threatened information, past and present numbers from those materials (e.g., publications, destruction, modification, or and distribution of the species involved maps, reports, and letters from curtailment of habitat or range; (2) and any threats faced by the species; (3) authorities). We will accept the overutilization for commercial, provides information regarding the petitioners’ sources and recreational, scientific, or educational status of the species over all or a characterizations of the information purposes; (3) disease or predation; (4) significant portion of its range; and (4) presented if they appear to be based on inadequacy of existing regulatory is accompanied by the appropriate accepted scientific principles, unless we mechanisms to address identified supporting documentation in the form have specific information in our files threats; rand (5) any other natural or of bibliographic references, reprints of that indicates the petition’s information manmade factors affecting the species’ pertinent publications, copies of reports is incorrect, unreliable, obsolete, or existence (16 U.S.C. 1533(a)(1), 50 CFR or letters from authorities, and maps (50 otherwise irrelevant to the requested 424.11(c)). Information presented on CFR 424.14(b)(2)). action. Information that is susceptible to these factors should be specific to the Under the ESA, a listing more than one interpretation or that is species and should reasonably suggest determination addresses the status of a contradicted by other available that one or more of these factors may be species, which is defined to also include information will not be dismissed at the operative threats that act or have acted subspecies and, for any vertebrate 90-day finding stage, so long as it is on the species to the point that it may

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warrant protection under the ESA. of similar environmental conditions or The recent taxonomic revision to some Broad statements about generalized other reasons); and (2) morphologically Pocillopora species did not propose any threats to the species, or identification different colonies may be the same changes to P. meandrina (Schmidt- of factors that could negatively impact species (i.e., colonies of the same Roach et al., 2014); (2) other recent a species, do not constitute substantial species appear different because of papers have found that Pocillopora information indicating that listing may different environmental conditions or species, including P. meandrina, are be warranted. We look for information other reasons). Because of the genetically distinct from one another indicating that not only is the particular taxonomic uncertainty for the genus (Johnston et al., 2017, 2018), and; (3) the species exposed to a factor, but that the Pocillopora, we concluded in the final growing genetic information on P. species may be responding in a negative listing rule that no final listing decision meandrina could lead to the description fashion; then we assess the potential could be made for the two Pocillopora of sub-species rather than new species, significance of that negative response. species that had been proposed for but sub-species are treated as species listing in 2012 (P. elegans, P. danae; 79 under the ESA. Therefore, P. meandrina Taxonomy of the Petitioned P. meandrina FR 53851; September 10, 2014). may be a type of entity that is eligible Other recent papers on genetic or for listing under the ESA. As described in the final rule to list morphological aspects of Pocillopora 20 species of coral under the ESA (79 taxonomy that were in our files when Habitat, Range, and Life History FR 53851; September 10, 2014), the we received the petition (Johnston et al., Pocillopora meandrina occurs on morphology-based taxonomy of the 2017; Johnston et al., 2018; Pas-Garcia et shallow reefs and amongst coral genus Pocillopora, including P. al., 2015; Schmidt-Roach et al., 2014) communities on rocky reefs at depths of meandrina, has been called into indicate that gross morphological 1 to 27m, and is common in high-energy question by several recent genetics plasticity is characteristic of Pocillopora reef front environments (shallow papers. A range-wide phylogeographic species, thus morphological data should forereef) throughout its range (Fenner, survey that included most currently be supplemented with genetic data for 2005; Hoeksma et al., 2014; Veron, recognized pocilloporid species found accurate identification of species 2000). In Hawaii and the eastern Pacific, that reliance on colony morphology is (Johnston et al., 2017). A combined P. meandrina is often the dominant broadly unreliable for species genetics and morphology study of species in shallow forereef coral identification, and that several genetic several Pocillopora species, including P. communities (Fenner, 2005; Glynn, groups have highly limited geographic meandrina, did not propose any 2001). It is found on most coral reefs of distributions. The study concluded that taxonomic changes to P. meandrina. the Indo-Pacific and eastern Pacific, ‘‘a taxonomic revision informed The study found that, in contrast to with its range encompassing over 180° foremost by genetic evidence is needed morphological similarities, P. verrucosa longitude from the western Indian for the entire genus’’ (Pinzo 301;n et al., and P. meandrina are very distinct Ocean to the eastern Pacific Ocean, and 2013). Similarly, a phylogeographic genetically, and P. meandrina is much approximately 60° latitude from the survey of several currently recognized more closely related to P.eydouxi than northern Ryukyu Islands to central pocilloporid species representing a to P. verrucosa genetically (Schmidt- western Australia in the western Pacific, range of atypical morphologies thought Roach et al., 2014). The morphological and the Gulf of California to Easter to be rare or endemic to remote plasticity of Pocillopora species was Island in the eastern Pacific (Corals of locations throughout the Indo-Pacific shown by a study of P. damicornis and the World website http:// found that (1) the current taxonomy of P. inflata at a site in the southern Gulf www.coralsoftheworld.org/). Pocillopora based on colony of California that coincided with a shift Pocillopora meandrina has a morphology shows little to a higher frequency of storms and branching colony morphology, is a correspondence with genetic groups; (2) lower water turbidity. Over the 44- broadcast spawner, and has rapid colony morphology is far more variable month period of the study, 23 percent skeletal growth, allowing it to recruit than previously thought; and (3) there of the P. damicornis colonies changed quickly to available substrate and are numerous cryptic lineages (i.e., two shape to P. inflata morphology, successfully compete for space (Darling or more distinct lineages that are providing an in situ demonstration of et al, 2012). High recruitment rates, classified as one due to morphological the influence of temporal shifts in rapid skeletal growth, and successful similarities). The study concluded that environmental conditions on competition are well documented for P. ‘‘the genus Pocillopora is in need of morphologically plastic responses (Pas- meandrina in Hawaii (e.g., Brown, 2004; taxonomic revision using a combination Garcia et al., 2015). A genomic study Grigg and Maragos, 1974) and the of genetic, microscopic characters, and found that Pocillopora species are eastern Pacific (e.g., Jimee´nez and reproductive data to accurately genetically distinct from one another, Cortee´s, 2003). delineate species’’ (Marti-Puig et al., and that there is a lack of introgressive While such competitive reef coral 2014). Likewise, a more limited study of hybridization between species. Some of species typically dominate ideal several currently recognized these authors went on to develop a environments, they also have higher pocilloporid species in Moorea, French genetic technique for identification of susceptibility to threats such as elevated Polynesia found that genetic groups do Hawaiian Pocillopora species, and seawater temperatures than reef coral not correspond to colony morphology, found that morphology-based species with generalist, weedy, or stress- and exhibit a wide range of identifications often led to P. ligulata tolerant life histories (Darling et al., morphological variation (Forsman et al., being mistaken for P. meandrina 2012). For example, P. meandrina was 2013). (Johnston et al., 2018). among the most affected reef coral These studies demonstrate that colony Despite doubt raised by traditional species in the 2014 and 2015 mass morphology in pocilloporids is a poor morphology-based taxonomy, other bleaching events in Hawaii (Kramer et indicator of taxonomic relationships for readily available information in our files al., 2016; Rodgers et al., 2017). That the following reasons: (1) presents substantial scientific or said, the life history characteristics of P. Morphologically similar colonies may commercial information indicating that meandrina provide some buffering not be the same species (i.e., colonies of P. meandrina may constitute a valid against threats such as warming- different species appear similar because species for the following reasons: (1) induced bleaching by allowing for rapid

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recovery from die-offs. For example, in et al., 2017; see ‘‘Other Natural or Analysis of ESA Section 4(a)(1) Factors 2016, P. meandrina populations in the Manmade Factors—Ocean Warming’’ Although the petition presents main Hawaiian Islands were already section below). While there are information on at least four of the five showing signs of recovery from the 2014 currently no estimates available of the ESA factors in section 4(a)(1) of the ESA and 2015 bleaching mortality (PIFSC, total abundance or overall population (e.g., present modification of its habitat; unpublished data). trends for P. meandrina in the main disease and predation; inadequacy of The species has several other Hawaiian Islands, the above information regulatory mechanisms; and other characteristics that may also provide strongly indicates that the species has natural or manmade factors), the buffering against some threats, been in decline in this area, and that the information presented in the petition, including the capacity for decline was accelerated by the back-to- together with other readily available acclimatization and adaptation to back mass bleaching events of 2014 and information in our files, regarding ocean changing conditions, the potential for 2015. warming (Factor E) is substantial range expansion as previously enough to make a determination that a unsuitable habitat becomes suitable, and It is likely that P. meandrina has a broad range that encompasses declined in abundance across most, if reasonable person conducting an extensive habitat heterogeneity. The not all, of its range, over the past 50 to impartial scientific review could bleaching and mortality of some 100 years, and that the decline has conclude that this species may warrant colonies of a coral species on a reef, recently accelerated. For most of the listing as endangered or threatened followed by the recovery of hardier world’s reef corals, Carpenter et al. based on this factor alone. As such, we colonies, is the process by which (2008; Supplementary Information) focus our discussion below on ocean acclimatization and adaptation of a extrapolated species abundance trend warming and subsequent warming- species to ocean warming occurs, and estimates from total live coral cover induced coral bleaching and mortality, has been documented in some trends (i.e., all reef coral species and present our evaluation of the Pocillopora species (e.g., Rodrı´guez- combined) and habitat types. For P. information regarding this factor alone Troncoso, et al., 2010; Coles et al., meandrina, the overall decline in and its impact on the extinction risk of 2018). As conditions change in response abundance was estimated at 22 percent the species. However, we note that in to ocean warming, some areas that were over the 30-year period up to 2006 the status review for this species, we previously too cold for reef corals may (‘‘Percent Population Reduction’’), and will evaluate all ESA section 4(a)(1) factors to determine whether any one or become suitable, potentially allowing 10 percent over the 30 year period up a combination of these factors are range expansion of certain species into to the 1998 bleaching event (‘‘Back-cast causing declines in the species or likely these areas (Yamano et al., 2011; Yara et Percent Population Reduction’’). to substantially negatively affect the al., 2011). Finally, habitat conditions are However, total live coral cover trends species such that that P. meandrina is highly heterogeneous across the ranges are highly variable both spatially and either presently at risk of extinction or of broadly-distributed reef corals such temporally, thus data from the same likely to become so in the foreseeable as P. meandrina, creating a patchwork location and time period can be future. of conditions that may potentially interpreted differently (Bellwood et al., provide refugia to threats (Fine et al., 2004; Sweatman et al., 2011), and Other Natural or Manmade Factors— 2013; McClanahan et al., 2011). species trends do not necessarily Ocean Warming Abundance and Population Trends correlate with overall live coral cover Information presented in the petition trends. Thus, quantitative inferences of Although there is little species- and other readily available information specific, range-wide data on P. species-specific trends from total live in our files indicate that the most meandrina’s abundance and population coral cover trends should be interpreted important threat to P. meandrina across trends, there are some data available on with caution. At the same time, an its range currently and in the future, and the species’ abundance and population extensive body of literature documents to the Indo-Pacific reef coral trends in the main Hawaiian Islands global declines in live coral cover, communities of which P. meandrina is portion of the Hawaiian archipelago, accompanied by shifts to coral reef a part, is ocean warming and subsequent which indicate a significant decrease in communities dominated by hardier warming-induced coral bleaching and coral cover over a recent 14-year period, coral species or algae over the past 50 mortality. Based on this information, we followed by severe bleaching events. to 100 years (e.g., Birkeland, 2004; provide summaries of the (1) observed The Hawaii Coral Reef Assessment and Brainard et al., 2011; Pandolfi et al., ocean warming to date; (2) projected Monitoring Program (CRAMP) monitors 2003; Sale and Szmant, 2012; Veron et ocean warming; (3) observed effects of species-level live coral cover at 60 al., 2009). Recently, these changes have warming-induced mass bleaching on permanent stations throughout the main accelerated in response to an Indo-Pacific reef coral communities and Hawaiian Islands. From 1999 to 2012, P. unprecedented series of mass bleaching P. meandrina to date; and (4) projected meandrina decreased in live coral cover events across the majority of the world’s effects of warming-induced mass by 36.1 percent for all stations coral reefs (Hoegh-Guldberg et al., 2017; bleaching on Indo-Pacific reef coral combined (Rodgers et al., 2015). Hughes 2018a, 2018b; Lough et al., communities and P. meandrina. Subsequently, P. meandrina was 2018), 90 percent of which are in the (1) Observed Ocean Warming. As severely impacted in parts of the Indo-Pacific. Given that P. meandrina described in the 2014 final rule listing Hawaiian archipelago due to back-to- occurs in many areas affected by these 20 reef coral species as threatened (79 back warming-induced bleaching events broad changes, and it is susceptible to FR 53851; September 10, 2014), we in 2014 and 2015. Surveys of the both global and local threats, the species considered the International Panel on impacts of these bleaching events on P. likely declined in abundance over the Climate Change’s (IPCC) Fifth meandrina in the northwestern and past 50 to 100 years across most, if not Assessment Report (AR5) ‘‘Climate main Hawaiian Islands show high levels all, of its range, and that the decline has Change 2013: The Physical Science of bleaching and post-bleaching recently accelerated; but, a precise Basis’’ (IPCC, 2013) to be the best mortality in some locations (Couch et quantification is not possible based on available information on the physical al., 2017; Kramer et al., 2016; Rodgers the limited species-specific information. basis of ocean warming as well as future

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projections. Thus the following section (e.g., RCP2.6 = 2.6 W/m2 in 2100). The considerably greater (IPCC, 2013). As is based largely on IPCC (2013), four pathways have atmospheric CO2 described in detail in the RCP8.5 supplemented by more recent equivalents of 421 (RCP2.6), 538 Projections section of the 2014 coral information. Since the Industrial (RCP4.5), 670 (RCP6.0), and 936 ppm final listing rule, these global mean Revolution in the mid-19th century, the (RCP 8.5) in 2100, and follow very projections are not necessarily magnitude and pace of greenhouse gases different trajectories to reach those representative of ocean surface emissions (GHGs; e.g., carbon dioxide endpoints. Mean global warming temperature conditions throughout the (CO2) and methane) have rapidly estimates by 2100 for the pathways are ranges and habitats of reef corals in the increased, resulting in steadily higher 1.0°C (RCP2.6), 1.8°C (RCP4.5), 2.2°C future, due both to spatial variability atmospheric GHG concentrations, the (RCP6.0), and 3.7°C (RCP8.5). The four and to statistical range of the RCP8.5 most influential of which is CO2. The new pathways were developed with the ocean warming projections (79 FR IPCC found that these changes have intent of providing a wide range of total 53851; September 10, 2014). resulted in warming of the global climate forcing to guide policy (3) Observed Effects of Warming- climate system since the 1950s due to discussions and specifically include one induced Mass Coral Bleaching. The trapping of the sun’s heat in the mitigation pathway leading to a very frequency, intensity, and magnitude of atmosphere by the GHGs (i.e., the low forcing level (RCP2.6), two mass coral bleaching events has rapidly greenhouse effect). With regard to global stabilization pathways (RCP4.5 and increased since the early 1980s, ocean warming that has already RCP6), and one pathway with continued suggesting that tropical coral reef occurred, the IPCC determined that the high GHG emissions (RCP8.5; IPCC, systems are transitioning to a new era in upper ocean (0¥700 m) warmed from 2013). which the interval between recurrent 1971 to 2010, including warming of the The climate change projections, bouts of coral bleaching is too short for upper 75 m by 0.11°C per decade. including for ocean warming, ocean a full recovery of mature assemblages Warming varied regionally among the acidification, and sea level rise, in the (Hughes et al., 2018b). oceans, but all oceans warmed between 2014 coral final listing rule were based Warming-induced coral bleaching 1971 and 2010, including the tropical on RCP8.5 in IPCC’s AR5 (IPCC, 2013). occurs when elevated seawater and sub-tropical Indo-Pacific (IPCC, RCP8.5 assumes a continued status quo temperatures cause the expulsion of the 2013). increase in global GHG emissions over host coral’s symbiotic zooxanthellae in IPCC (2013) was based on data the 21st century. The NMFS 2014 rule response to thermal stress. While mild collected through 2010, but overall for 20 reef-building corals used RCP8.5 to moderate bleaching does not global warming (oceans and land as its basis. Indeed, global energy- necessary cause coral mortality, combined) and ocean warming have related CO2 emissions grew by repeated or prolonged bleaching can both continued at an even greater pace approximately 10 percent, with seven of lead to colony mortality. Many coral since then. Global temperatures (ocean those 10 years setting new historic highs physiological processes are optimized to and land combined) in 2015 and 2016 (IEA, 2018); and global atmospheric CO2 the local long-term seasonal and were the warmest since instrumental concentration grew from 385 to 407 interannual variations in seawater record keeping began in the 19th parts per million, with each year setting temperature experienced by the corals, century (NASA, 2016). Ocean warming new historic highs, according to and an increase of only 1°C–2°C above has continued, and there was more NOAA’s Earth System Research the normal local seasonal maximum can ocean warming in 2014–2016 than any Laboratory station on Mauna Kea, induce bleaching. Bleaching is best previous three-year period on record Hawaii (https://www.esrl.noaa.gov/gmd/ predicted by using an index of (Jewett and Romanou, 2017). There is ccgg/trends/). Thus, the best available accumulated thermal stress above a consensus among several different current information continues to locally established threshold (Brainard methods of monitoring seawater support the NMFS policy that RCP8.5 is et al., 2011). Most coral species are temperatures that ocean warming has the most likely pathway in the future. susceptible to bleaching, but this continued unabated since 2010 both RCP8.5 projects that global annual susceptibility varies among taxa. In globally and regionally in all of the mean ocean surface temperatures will addition, many coral species exhibit world’s oceans (Gleckler et al., 2016; increase from 2013 levels by various levels of adaptation or Cheng et al., 2017; Wang et al., 2018). approximately 0.4–1.0°C by 2030, acclimatization to elevated seawater Between 1998 and 2015, the greatest approximately 0.7–2.0°C by 2060, and temperatures. While coral bleaching warming was recorded in the Southern approximately 2.0–5.0°C by 2100, patterns are complex, there is general Ocean, the tropical/subtropical Pacific further exacerbating the impacts of agreement that thermal stress has led to Ocean, and the tropical/subtropical ocean warming on corals and coral accelerated bleaching and mass Atlantic Ocean (Cheng, et al., 2017). reefs. In the Indo-Pacific, projected mortality during the past several (2) Projected Ocean Warming. IPCC’s changes in annual median ocean surface decades. During the years 1983, 1987, AR5 uses projected changes in the temperatures under RCP8.5 will 1995, 1996, 1998, 2002, 2004, 2005, global climate system to model potential increase from 2013 levels by 2014, 2015, and 2016, widespread patterns of future climate based on a set approximately 0.0–1.0°C by 2035, 1.0– warming-induced coral bleaching and of four Representative Concentration 3.0°C by 2065, and 2.0–5.0°C by 2100. mortality was documented in many reef Pathways (RCPs) that provide a standard Spatial variability in the projections coral communities that P. meandrina is framework for consistently modeling consists mostly of larger increases in the part of in the Indo-Pacific and the future climate change. The RCP system Red Sea, Persian Gulf, and the Coral eastern Pacific (Jokiel and Brown, 2004; is based on levels of positive ‘‘radiative Triangle, and lower increases in the Kenyon and Brainard, 2006; Brainard et forcing,’’ defined as the net energy gain central and eastern Indian Ocean and al., 2011; Rodgers et al., 2017; Hughes relative to the 1986–2005 average by the south-central Pacific. The percent et al., 2017a, 2018a). The bleachings of year 2100 in terms of watts per square ranges in the projections described 2014–2016 were the longest, most meter (W/m2); thus, higher values above are for the 25 to 75 percent range widespread, and likely the most equate to greater warming over the time confidence intervals, however the range damaging coral bleaching events on period. The four pathways are named of projections within the 5 to 95 percent record. They affected more coral reefs RCP2.6, RCP4.5, RCP6.0, and RCP8.5 range confidence intervals are than any previous global bleaching

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event, and were worse in some locales central and northern GBR to determine mid-21st century then modestly decline than ever recorded before (e.g., Great the responses of 31 reef coral taxonomic as renewable energy becomes more Barrier Reef/GBR, Kiribati, Jarvis groups to the bleaching event, including common, and is most similar to RCP6.0 Island). Heat stress during this event ‘‘other Pocillopora’’ (P. meandrina and (IPCC, 2013). Despite the drop of GHGs also caused mass bleaching in several P. verrucosa). This group was the third- in the late 21st century in the A1B reefs where bleaching had never been most bleached of the 31 groups. A sub- scenario, this analysis projected recorded before (e.g., northernmost sample of 43 of the most affected reefs precipitous declines in live coral cover GBR; Eakin, 2017). was re-surveyed in November 2016 to (all reef corals combined, including P. According to the information in the determine the extent of post-bleaching meandrina) in the northwestern petition and other readily available mortality and subsequent loss of live Hawaiian Islands between 2030 and information in our files, warming- coral cover, which showed that the 2050, and steady declines over the 21st induced bleaching and mortality have ‘‘other Pocillopora’’ group had century in the main Hawaiian Islands impacted P. meandrina, including in approximately 55 percent loss of live (Hoeke et al., 2011). These results the Hawaiian archipelago and the GBR. coral cover (Hughes et al., 2017a, illustrate the concept of ‘‘commitment’’, In Hawaii, P. meandrina is one of the 2018a). i.e., the world’s oceans are currently most common coral species and often Although difficulty in identification committed to some future warming from dominates the forereef coral community. of Pocillopora species and lack of the CO2 build-up already in the The consecutive bleaching events of species-level field surveys means little atmosphere, even if anthropogenic 2014 and 2015 in the Hawaiian of the available information on the emissions went to zero now (IPCC, archipelago were unprecedented in impacts of warming-induced bleaching 2013). As explained above, for the scale, intensity, and magnitude, and P. on Pocillopora species is specifically for purpose of this finding, we will assume meandrina was one of the most severely P. meandrina, the family Pocilloporidae that RCP8.5 in IPCC’s Fifth Assessment affected reef coral species (Couch et al., and the genus Pocillopora are highly Report (IPCC, 2013) is the most likely 2017; Rodgers et al., 2017). Surveys in susceptible to warming-induced pathway, but Hoeke et al. (2011) base late 2014 at multiple sites on four bleaching relative to other reef corals. A their analysis on the more optimistic islands in the northwestern Hawaiian survey of the susceptibilities of 40 reef A1B scenario (similar to RCP6.0). Thus, Islands showed 15.5 percent of P. coral taxa to the 1998 warming-induced we project that conditions in the meandrina colonies had been bleached mass bleaching event on the GBR found Hawaiian Islands in the future will be (colonies that lost >50% of that three Pocilloporidae species (P. worse than projected by Hoeke et al. pigmentation). Surveys were repeated in damicornis, Stylophora pistillata, (2011). 2015 for post-bleaching mortality of Seriatopora hysrix) were among the coral species making up >1 percent of seven most susceptible taxa (Marshal Projections of the responses of the live coral at the 2014 survey sites. Only and Baird, 2000). Similarly, a survey of world’s corals and coral reefs one site had >1 percent of P. meandrina the sensitivities of 39 reef coral genera ecosystems to ocean warming have been in 2014, and that site had no P. to the 1998 bleaching event in the addressed recently by several papers meandrina in 2015 (Couch et al., 2017). Indian Ocean found Pocillopora to be that project coral responses to one or Surveys of eight sites in Hanauma Bay eighth-most susceptible of the 39 genera more of the IPCC’s four pathways in the on Oahu in 2015 and 2016 found that (McClanahan et al., 2007). In a study future. An analysis of the likely reef 64 percent of P. meandrina colonies carried out from 1997 to 2010 on the coral disease outbreaks resulting from showed ‘‘signs of bleaching’’, and that responses of a diverse reef coral ocean warming projected by RCP4.5 and 1.3 percent of the P. meandrina colonies assemblage in Japan to bleaching events RCP8.5 concluded that both pathways suffered total post-bleaching mortality in 1998 and 2001, Pocillopora species are likely to cause sharply increased, (Rodgers et al., 2017). Surveys at eight fared the worst of all genera, nearly but spatially highly variable, levels of permanent monitoring sites on the west dying out in 1998 and not recovering by coral disease in the future, and that the coast of the Big Island of Hawaii in 2015 2010 (van Woesik, et al., 2011). A meta- outbreaks would be more widespread, showed a mean loss in live coral cover analysis of studies conducted between frequent, and severe under RCP8.5 than (all species combined) of 49.6 percent. 1987 and 2012 at five locations in the RCP4.5 (Maynard et al, 2015). An Surveys of the seven sites where P. Indo-Pacific (Moorea, GBR, Kenya, analysis of the timing and extent of meandrina had been abundant before Hawaii, and Taiwan) found that the Annual Severe Bleaching (ASB) of the the bleaching events showed that 77.6 absolute and relative cover of many world’s coral reefs under RCP4.5 vs percent of the P. meandrina colonies coral genera including Pocillopora RCP8.5 found that the global average suffered total post-bleaching mortality declined in abundance, while some timing of ASB would be only 11 years (Kramer et al., 2016). genera showed no change in abundance, later under RCP4.5 than RCP8.5, and The 2016 warming-induced bleaching and a few genera increased in that >75 percent of all reefs still would event across the Indo-Pacific was the abundance (Edmunds et al., 2014). experience ASB before 2070 under worst in recorded history in terms of (4) Projected Effects of Warming- RCP4.5 (van Hooidonk et al, 2016). An severity and duration of elevated induced Mass Coral Bleaching. analysis of the responses of coral reefs seawater temperatures and ensuing Projections of ocean warming and to increased warming and acidification mass coral bleaching and mortality subsequent mass coral bleaching suggest under all four pathways found that only (Lough et al., 2018). Much of the GBR these events will increase in frequency, RCP2.6 would allow the current was affected by the elevated seawater intensity, and magnitude across the downward trend in coral reefs to temperatures, resulting in bleaching Indo-Pacific, including the great stabilize, and that RCP4.5 would likely levels of 75–100 percent on many of the majority of P. meandrina’s range. Hoeke drive the elimination of most coral reefs GBR’s northern reefs, and a mean et al. (2011) projected future changes to by 2040–2050 (Hoegh-Guldberg et al., reduction in live coral cover of 30 coral growth and mortality in the 2017). Hughes et al., (2017b) analyzed percent across the entire 2,300 km GBR Hawaiian archipelago based the A1B the responses of coral reefs to RCP2.6 between March and November 2016. In scenario from the IPCC’s Fourth and to the implementation of the 2015 March and April 2016, a survey was Assessment Report (IPCC, 2007). This Paris Agreement (which would result in conducted on 83 reefs spanning the scenario assumes GHGs will peak in the a scenario roughly equivalent to RCP4.5)

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and found that RCP2.6 would result in Indo-Pacific, is projected to continue at (4) The effects of climate change, approximately the same amount of an accelerated rate in the future; (3) including ocean warming and additional warming and bleaching by substantial warming-induced mass acidification, on the distribution and 2100 that has occurred over the last bleaching of Indo-Pacific reef coral condition of P. meandrina and other century, and that implementation of the communities, including P. meandrina, organisms in coral reef ecosystems over Paris Agreement (i.e., RCP4.5) would has already occurred and continues to the short- and long-term; lead to severe consequences for coral occur; and (4) warming-induced mass (5) The effects of other threats reefs (Hughes et al., 2017b), despite the bleaching of Indo-Pacific reef coral including dredging; coastal fact that RCP6.0 and RCP8.5 would be communities, including P. meandrina, development; land-based sources of even worse. Another analysis regarding is projected to steadily increase in pollution, including coastal point responses of coral reefs if global frequency, intensity, and magnitude in source pollution, and agricultural and warming is limited to 1.5°C, 2.0°C, or the future. In short, ocean warming is land use practices; disease, predation, 3°C (roughly equivalent to RCP4.5, expected to continue to affect P. the trophic effects of fishing, the RCP6.0, and RCP8.5) found that meandrina throughout its range in the aquarium trade, physical damage from estimated levels of thermal stress would future. boats and anchors, marine debris, be approximately seven, 11, and 23 Petition Finding aquatic invasive species on the times, respectively, the level of thermal distribution and abundance of P. stress that these reefs have already After reviewing the information meandrina over the short- and long- experienced since 1878, and presented in the petition and other term; and the inadequacy of regulatory approximately two, three, and six times readily available information in our mechanisms; and the level of thermal stress experienced files, we find that listing P. meandrina (6) Management programs for in 2016 (Lough et al., 2018). across its range may be warranted based conservation of P. meandrina, including All five analyses considered the on the threat of ocean warming alone. mitigation measures related to any of impacts of one or both of the IPCC’s Therefore, in accordance with section the threats listed under (5) above. lower emissions pathways (RCP2.6 and 4(b)(3)(B) of the ESA and NMFS’ We request that all information be RCP4.5), and each analysis reached the implementing regulations (50 CFR accompanied by (1) supporting same conclusion: Even these lower 424.14), we will commence a status documentation such as maps, emissions pathways are likely to have review of this species. During the status bibliographic references, or reprints of more severe impacts to reef corals in the review, we will determine whether P. pertinent publications; and (2) the future than have been observed in meandrina is in danger of extinction submitter’s name, address, and any recent years (Hoegh-Guldberg et al., (endangered) or likely to become so association, institution, or business that 2017; Hughes et al., 2017b; Lough et al., (threatened) throughout all or a the person represents. 2018; Maynard et al, 2015; van significant portion of its range. If listing Hooidonk et al, 2016), partially because is warranted, we will publish a References Cited the GHG emissions that have already proposed rule and solicit public A complete list of references upon occurred have irreversibly locked in a comments before developing and request from Lance Smith, NOAA IRC, certain amount of warming due to publishing a final rule. If we determine NMFS/PIRO/PRD, 1845 Wasp Blvd., ‘‘commitment,’’ as described above. that the species is in danger of Bldg. 176, Honolulu, HI 96818. Indo-Pacific reef corals would likely be extinction or likely to become so in the even more severely impacted by foreseeable future throughout all of its Authority warming-induced bleaching events range, we will list the species as The authority for this action is the resulting from ocean warming under the endangered or threatened, and it will be Endangered Species Act of 1973, as other two pathways in the future, unnecessary to determine if Hawaii amended (16 U.S.C. 1531 et seq.). especially RCP8.5, as shown by two constitutes a significant portion of the Dated: September 17, 2018. analyses (Hoegh-Guldberg et al., 2017b; species’ range. If P. meandrina is not van Hooidonk et al, 2016). Although P. proposed for listing as endangered or Samuel D. Rauch III, meandrina has several life history threatened throughout all of its range, Deputy Assistant Administrator for characteristics that may buffer some of we will then determine if Hawaii Regulatory Programs, National Marine Fisheries Service. the effects of ocean warming (refer back constitutes a significant portion of the to the Habitat, Range, and Life History species’ range. If so, we will determine [FR Doc. 2018–20512 Filed 9–19–18; 8:45 am] section of this finding), based on the the status of P. meandrina in Hawaii, BILLING CODE 3510–22–P effects of warming-induced bleaching to and proceed accordingly (79 FR 37578; date on P. meandrina and its relatively July 1, 2014). high susceptibility to warming, the DEPARTMENT OF COMMERCE information in the petition and other Information Solicited National Oceanic and Atmospheric readily available information in our files To ensure that the status review is Administration suggests this species may be severely based on the best available scientific affected across its range in the future by and commercial data, we are soliciting 50 CFR Part 635 ocean warming projected under RCP8.5. information on whether P. meandrina is Ocean Warming Summary. From the endangered or threatened. Specifically, [Docket No. 180212159–8159–01] above analysis of ocean warming and its we are soliciting information in the RIN 0648–BH75 effects on P. meandrina and the coral following areas: reef community of which P. meandrina (1) Historical and current distribution Atlantic Highly Migratory Species; is a part, we find four key points to be and abundance of P. meandrina Shortfin Mako Shark Management relevant: (1) Substantial ocean warming, throughout its range; Measures; Proposed Amendment 11; including in the tropical/subtropical (2) Historical and current condition of Comment Period Extension Indo-Pacific, has already occurred and P. meandrina and its habitat; continues to occur; (2) ocean warming, (3) Population density and trends of AGENCY: National Marine Fisheries including in the tropical/subtropical P. meandrina; Service (NMFS), National Oceanic and

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Atmospheric Administration (NOAA), • Mail: Submit written comments to Atlantic Tunas (ICCAT) for North Commerce. Guy´ DuBeck, NMFS/SF1, 1315 East- Atlantic shortfin mako sharks. The ACTION: Proposed rule; extension of West Highway, National Marine North Atlantic shortfin mako shark comment period. Fisheries Service, SSMC3, Silver Spring, stock is overfished and is experiencing MD 20910. overfishing. Consistent with the SUMMARY: NMFS previously published, Instructions: Please include the Magnuson-Stevens Fishery on July 27, 2018, a proposed rule to identifier NOAA–NMFS–2018–0011 Conservation and Management Act amend the 2006 Consolidated Atlantic when submitting comments. Comments (Magnuson-Stevens Act) and the Highly Migratory Species (HMS) Fishery sent by any other method, to any other Atlantic Tunas Convention Act (ATCA), Management Plan (FMP) based on the address or individual, or received after NMFS is proposing management results of the 2017 stock assessment and the close of the comment period, may measures that would reduce fishing a subsequent binding recommendation not be considered by NMFS. All mortality on shortfin mako sharks and by the International Commission for the comments received are a part of the establish a foundation for rebuilding the Conservation of Atlantic Tunas (ICCAT) public record and generally will be shortfin mako shark population for North Atlantic shortfin mako sharks. posted for public viewing on consistent with legal requirements. In The comment period on the proposed www.regulations.gov without change. the proposed rule, the end of the rule ends on October 1, 2018. In this All personal identifying information comment period was announced as extension of comment period, NMFS is (e.g., name, address), confidential October 1, 2018. However, due to extending the comment period to business information, or otherwise Hurricane Florence, the South Atlantic October 8, 2018, to provide an sensitive information submitted Fishery Management Council postponed opportunity for the South Atlantic voluntarily by the sender will be its previously scheduled meeting by Fishery Management Council (Council) publicly accessible. NMFS will accept several weeks. Without an extension of to be briefed, and to provide additional anonymous comments (enter ‘‘N/A’’ in the comment period, the Council would opportunities for the Council and other the required fields if you wish to remain be unable to receive the same briefing interested parties to comment on the anonymous). provided to other Councils prior to proposed rule. FOR FURTHER INFORMATION CONTACT: Guy´ providing comments on Amendment 11. DATES: The deadline for receipt of DuBeck or Karyl Brewster-Geisz at (301) As such, NMFS is extending the comments on the proposed rule 427–8503. comment period to provide an published on July 27, 2018 (83 FR SUPPLEMENTARY INFORMATION: The North opportunity to be briefed and an 35637) is extended from October 1, 2018 Atlantic shortfin mako stock is managed additional opportunity for the South to October 8, 2018. primarily under the authority of the Atlantic Fishery Management Council ADDRESSES: You may submit comments Magnuson-Stevens Act and also under and other interested parties to comment on the referenced proposed rule the Atlantic Tunas Convention Act on the proposed rule. Therefore, the published on July 27, 2018 (83 FR (ATCA). The 2006 Consolidated HMS comment period for the proposed rule is 35637), identified by NOAA–NMFS– FMP and its amendments are extended to October 8, 2018. 2018–0011, by any one of the following implemented by regulations at 50 CFR Authority: 16 U.S.C. 971 et seq.; 16 U.S.C. methods: part 635. 1801 et seq. • Electronic Submission: Submit all On July 27, 2018 (83 FR 35637), electronic public comments via the NMFS published a proposed rule that Dated: September 17, 2018. Federal e-Rulemaking Portal. Go to announced NMFS’ intent to amend the Samuel D. Rauch III, www.regulations.gov/ 2006 Consolidated Atlantic HMS FMP Deputy Assistant Administrator for #!docketDetail;D=NOAA-NMFS-2018- based on the results of the 2017 stock Regulatory Programs, National Marine 0011, click the ‘‘Comment Now’’ icon, assessment and a subsequent binding Fisheries Service. complete the required fields, and enter recommendation by the International [FR Doc. 2018–20457 Filed 9–19–18; 8:45 am] or attach your comments. Commission for the Conservation of BILLING CODE 3510–22–P

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Notices Federal Register Vol. 83, No. 183

Thursday, September 20, 2018

This section of the FEDERAL REGISTER Morgan-Jordan, Program Support Agriculture, Room 332A, Jamie L. contains documents other than rules or Coordinator, National Agricultural Whitten Building, Mail Stop 0321, 1400 proposed rules that are applicable to the Research, Extension, Education, and Independence Avenue SW, Washington, public. Notices of hearings and investigations, Economics Advisory Board; telephone: DC 20250–0321; or email: nareee@ committee meetings, agency decisions and (202) 720–3684; fax: (202)720–6199; or ars.usda.gov. All statements will rulings, delegations of authority, filing of petitions and applications and agency email: [email protected]. become a part of the official record of statements of organization and functions are SUPPLEMENTARY INFORMATION: the National Agricultural Research, examples of documents appearing in this Purpose of the meeting: To provide Extension, Education, and Economics section. advice and recommendations on the top Advisory Board and will be kept on file priorities and policies for food and for public review in the Research, agricultural research, education, Education, and Economics Advisory DEPARTMENT OF AGRICULTURE extension, and economics. The focus of Board Office. this meeting will be on the deliberation Office of the Secretary Done on at Washington, DC, this day of of the following report and September 11, 2018. Meeting Notice of the National recommendations: The relevance and Chavonda Jacobs-Young, Agricultural Research, Extension, adequacy of the climate and energy Acting, Deputy Under Secretary, Research, Education, and Economics Advisory needs programs of the USDA Research, Education, and Economics Acting Chief Board Education, and Extension mission area; Scientist. a report from the Science Advisory [FR Doc. 2018–20452 Filed 9–19–18; 8:45 am] AGENCY : Research, Education, and Council (a subcommittee of the NAREEE BILLING CODE 3410–03–P Economics, USDA. Advisory Board) on gene editing; and a ACTION: Notice of public meeting. report from the National Genetic Resources Advisory Council (a DEPARTMENT OF AGRICULTURE SUMMARY: In accordance with the subcommittee of the NAREEE Advisory Federal Advisory Committee Act, 5 Board) on aquatic and animal genetic Animal and Plant Health Inspection U.S.C. App 2, Section 1408 of the resources. A detailed agenda may be Service National Agricultural Research, received from the contact person [Docket No. APHIS–2018–0058] Extension, and Teaching Policy Act of identified in this notice or at https:// 1977 (7 U.S.C. 3123), and the nareeeab.ree.usda.gov/meetings/ Notice of Request for Revision to and Agricultural Act of 2014, the United general-meetings. Extension of Approval of an States Department of Agriculture Tentative Agenda: On Tuesday, Information Collection; Importation of (USDA) announces a virtual meeting of September 28, 2018, the meeting will be Fresh Peppers From Peru Into the the National Agricultural Research, held from 11:00 a.m. EDT until 1:30 Continental United States and the Extension, Education, and Economics p.m. EDT. Territories Advisory Board. Public Participation: This meeting is DATES: The National Agricultural open to the public via telephone and AGENCY: Animal and Plant Health Research Extension, Education, and any interested individuals wishing to Inspection Service, USDA. Economics Advisory Board will meet attend. Opportunity for public comment ACTION: Revision to and extension of virtually by telephone conference on will be offered. To attend the meeting approval of an information collection; September 28, 2018, from 11:30 a.m.– via telephone and/or make oral comment request. 1:00 p.m. Eastern Daylight Time (EDT). statements regarding any items on the The public may file written comments agenda, you must contact Michele Esch SUMMARY: In accordance with the before or up to October 12, 2018. or Shirley Morgan-Jordan at 202–720– Paperwork Reduction Act of 1995, this ADDRESSES: The meeting will take place 3684; email: [email protected] at notice announces the Animal and Plant virtually via teleconference. least 5 business days prior to the Health Inspection Service’s intention to Web Preregistration: Participants meeting. Members of the public will be request a revision to and extension of wishing to participate may preregister heard in the order in which they sign up approval of an information collection by calling 202–720–6012 or email at at the beginning of the meeting. The associated with the regulations for the [email protected]. Upon registration Chair will conduct the meeting to importation of fresh peppers from Peru you will receive a call-in number and facilitate the orderly conduct of into the continental United States and access code. business. Written comments by the Territories. Written comments may be sent to: attendees or other interested DATES: We will consider all comments The National Agricultural Research, stakeholders will be welcomed for the that we receive on or before November Extension, Education, and Economics public record before and up to two 19, 2018. Advisory Board Office, Room 332A, weeks following the Board meeting (or ADDRESSES: You may submit comments Whitten Building, United States by close of business Friday, October 12, by either of the following methods: Department of Agriculture, 1400 2018). All written statements must be • Federal eRulemaking Portal: Go to Independence Avenue SW, Washington, sent to Michele Esch, Designated http://www.regulations.gov/ DC 20250–0321. Federal Officer and Executive Director, #!docketDetail;D=APHIS-2018-0058. FOR FURTHER INFORMATION CONTACT: National Agricultural Research, • Postal Mail/Commercial Delivery: Michele Esch, Executive Director/ Extension, Education, and Economics Send your comment to Docket No. Designated Federal Official, or Shirley Advisory Board, U.S. Department of APHIS–2018–0058, Regulatory Analysis

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and Development, PPD, APHIS, Station required to be imported in commercial Done in Washington, DC, this 14th day of 3A–03.8, 4700 River Road Unit 118, consignments and accompanied by a September 2018. Riverdale, MD 20737–1238. phytosanitary certificate issued by the Kevin Shea, Supporting documents and any national plant protection organization Administrator, Animal and Plant Health comments we receive on this docket (NPPO) of Peru with an additional Inspection Service. may be viewed at http:// declaration stating that the consignment [FR Doc. 2018–20449 Filed 9–19–18; 8:45 am] www.regulations.gov/ was produced in accordance with the BILLING CODE 3410–34–P #!docketDetail;D=APHIS-2018-0058 or systems approach outlined in the in our reading room, which is located in regulations. These actions allow for the Room 1141 of the USDA South importation of fresh peppers from Peru DEPARTMENT OF AGRICULTURE Building, 14th Street and Independence while continuing to provide protection Avenue SW, Washington, DC. Normal against the introduction of plant pests U.S. Codex Office reading room hours are 8 a.m. to 4:30 into the United States and the Codex Alimentarius Commission: p.m., Monday through Friday, except Territories. Meeting of the Codex Committee on holidays. To be sure someone is there to We are asking the Office of Nutrition and Foods for Special Dietary help you, please call (202) 799–7039 Management and Budget (OMB) to Uses (CCNFSDU) before coming. approve our use of these information FOR FURTHER INFORMATION CONTACT: For collection activities, as described, for an AGENCY: U.S. Codex Office, USDA. information on the importation of fresh additional 3 years. ACTION: Notice of public meeting and request for comments. peppers from Peru into the continental The purpose of this notice is to solicit United States and the Territories, comments from the public (as well as SUMMARY: The U.S Codex Program is contact Ms. Claudia Ferguson, Senior affected agencies) concerning our sponsoring a public meeting on Regulatory Policy Coordinator, PPQ, information collection. These comments Tuesday, November 6, 2018. The APHIS, 4700 River Road Unit 39, will help us: objective of the public meeting is to Riverdale, MD 20737; (301) 851–2532. provide information and receive public For more detailed information on the (1) Evaluate whether the collection of comments on agenda items and draft information collection, contact Ms. information is necessary for the proper performance of the functions of the United States (U.S.) positions to be Kimberly Hardy, APHIS’ Information discussed at the 40th session of the Collection Coordinator, at (301) 851– Agency, including whether the information will have practical utility; Codex Committee on Nutrition and 2483. Foods for Special Dietary Uses (2) Evaluate the accuracy of our SUPPLEMENTARY INFORMATION: (CCNFSDU) of the Codex Alimentarius estimate of the burden of the collection Title: Importation of Fresh Peppers Commission in Berlin, Germany of information, including the validity of From Peru Into the Continental United November 26–30, 2018. The U.S. the methodology and assumptions used; States and the Territories. Manager for Codex Alimentarius and OMB Control Number: 0579–0434. (3) Enhance the quality, utility, and the Under Secretary, Office of Trade and Type of Request: Revision to and clarity of the information to be Foreign Agricultural Affairs, recognize extension of approval of an information collected; and the importance of providing interested collection. (4) Minimize the burden of the parties the opportunity to obtain Abstract: The Plant Protection Act collection of information on those who background information on the 40th (PPA, 7 U.S.C. 7701 et seq.) authorizes are to respond, through use, as Session of the CCNFSDU and to address the Secretary of Agriculture to restrict appropriate, of automated, electronic, items on the agenda. the importation, entry, or interstate mechanical, and other collection DATES: The public meeting is scheduled movement of plants, plant products, and technologies; e.g., permitting electronic for Tuesday, November 6, 2018 from other articles to prevent the submission of responses. 1:00 p.m. to 3:00 p.m. introduction of plant pests into the Estimate of burden: The public ADDRESSES: The public meeting will United States or their dissemination burden for this collection of information take place at the Food and Drug within the United States. Regulations is estimated to average 1 hour per Administration (FDA) Center for Food authorized by the PPA concerning the response. Safety and Applied Nutrition, Wiley importation of fruits and vegetables into Building, Room 1A002, 55 Campus the United States from certain parts of Respondents: Exporters, importers, and the NPPO of Peru. Drive, College Park, MD 20740. the world are contained in ‘‘Subpart— Documents related to the 40th Session Fruits and Vegetables’’ (7 CFR 319.56– Estimated annual number of of the CCNFSDU will be accessible via 1 through 319.56–83). respondents: 15. the internet at the following address: The regulations in § 319.56–73 allow Estimated annual number of http://www.codexalimentarius.org/ the importation of fresh peppers into the responses per respondent: 16. meetings-reports/en. continental United States and the Estimated annual number of Dr. Douglas Balentine, U.S. Delegate Territories from Peru. As a condition of responses: 249. to the 40th Session of the CCNFSDU, entry, the peppers have to be produced invites U.S. interested parties to submit in accordance with a systems approach Estimated total annual burden on their comments electronically to the that includes requirements for respondents: 294 hours. (Due to following email address: operational workplans, quality control averaging, the total annual burden hours [email protected]. programs, fruit fly trapping, pre-harvest may not equal the product of the annual Call-In-Number: If you wish to production site inspections, production number of responses multiplied by the participate in the public meeting for the site and packinghouse registration, reporting burden per response.) 40th Session of the CCNFSDU by emergency action notifications, notices All responses to this notice will be conference call, please use the call-in- of arrival for imports, and packinghouse summarized and included in the request number listed below: procedures designed to exclude for OMB approval. All comments will Call-In-Number: 1–877–465–7975— quarantine pests. The peppers are also also become a matter of public record. U.S. Toll Free.

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The participant code will be posted nutritional aspects proposed for opportunity to pose questions and offer on the web page below: http:// inclusion in Codex standards, comments. Written comments may be www.fsis.usda.gov/wps/portal/fsis/ guidelines, and related texts. offered at the meeting or sent to Douglas topics/international-affairs/us-codex- The CCNFSDU is hosted by Germany. Balentine, U.S. Delegate for the 40th alimentarius/public-meetings. The U.S. attends CCNFSDU as a Session of the CCNFSDU (see FOR FURTHER INFORMATION CONTACT: member country of Codex. ADDRESSES). Written comments should state that they relate to activities of the About the 40th Session Of the Issues To Be Discussed at the Public 40th Session of the CCNFSDU. CCNFSDU: Doug Balentine, Director, Meeting Office of Nutrition and Food Labelling, Additional Public Notification Center for Food Safety and Applied The following items on the Agenda Nutrition, U.S. Food and Drug for the 40th Session of the CCNFSDU Public awareness of all segments of Administration, 5001 Campus Drive will be discussed during the public rulemaking and policy development is (HFS–830), College Park, MD 20740. meeting: important. Consequently, the U.S. Phone: +1 240 402 2373. Fax: +1 (301) • Matters referred by the Codex Codex Office will announce this Federal 436–2636. Email: Douglas.Balentine@ Alimentarius Commission and its Register publication on-line through the fda.hhs.gov. subsidiary bodies FSIS web page located at: http:// • About the Public Meeting: Doreen Matters of Interest Arising from FAO www.fsis.usda.gov/federal-register. The Chen-Moulec, U.S. Codex Office, 1400 and WHO: U.S. Codex Office also offers an email Æ Independence Avenue SW, Room 4861, Review of the Standard for Follow- subscription service which provides South Agriculture Building, up Formula (CXS 156–1987)1 automatic and customized access to Washington, DC 20250, Phone: (202) D Comments in reply to CL 2018/62– selected food safety news and NFSDU 720–4063, Fax: (202) 720–3157, Email: Æ information. This service is available at: [email protected]. Review of the Standard for Follow- http://www.fsis.usda.gov/subscribe. up Formula (CXS 156–1987)2 SUPPLEMENTARY INFORMATION: Options range from recalls to export D Comments in reply to CL 2018/63– information, regulations, directives, and Registration NFSDU notices. Customers can add or delete Æ Proposed Draft Guideline for Attendees may register to attend the subscriptions themselves, and have the Ready-to-use Therapeutic Foods option to password protect their public meeting by emailing D Comments at in reply to CL 2018/ accounts. [email protected] by 64–NFSDU October 24, 2018. Æ Proposed Draft Definition for USDA Non-Discrimination Statement Early registration is encouraged Biofortification because it will expedite entry into the D Comments in reply to CL 2018/65– No agency, officer, or employee of the building. The meeting will take place in NFSDU USDA shall, on the grounds of race, a Federal building. Attendees should Æ Proposed Draft NRV–NCD for EPA color, national origin, religion, sex, bring photo identification and plan for and DHA long chain omega-3 fatty gender identity, sexual orientation, adequate time to pass through the acids disability, age, marital status, family/ security screening systems. Attendees D Comments in reply to CL 2018/66– parental status, income derived from a who are not able to attend the meeting NFSDU public assistance program, or political in person, but who wish to participate, Æ Proposed draft Claim for ‘‘free’’ of beliefs, exclude from participation in, may do so by phone, as discussed Trans Fatty Acids deny the benefits of, or subject to above. D Comments in reply to CL 2017/89/ discrimination any person in the United States under any program or activity Background OCS–NFSDU Æ Discussion paper of NRV–R for conducted by the USDA. Codex was established in 1963 by two older infants and young children United Nations organizations, the Food Æ How To File a Complaint of Discussion paper on mechanism/ Discrimination and Agriculture Organization (FAO) and framework for considering the the World Health Organization (WHO). technological justification of food To file a complaint of discrimination, Through adoption of food standards, additives complete the USDA Program codes of practice, and other guidelines Æ Discussion paper on harmonized Discrimination Complaint Form, which developed by its committees, and by probiotic guidelines for use in foods may be accessed online at http:// promoting their adoption and and dietary supplements www.ocio.usda.gov/sites/default/files/ implementation by governments, Codex Æ Discussion paper on general docs/2012/Complain_combined_6_8_ seeks to protect the health of consumers guidelines to establish nutritional 12.pdf, or write a letter signed by you and ensure fair practices in the food profiles or your authorized representative. trade. • Other Business and Future Work. Send your completed complaint form The CCNFSDU is responsible for: Each issue listed will be fully or letter to USDA by mail, fax, or email. (a) Studying nutrition issues referred described in documents distributed, or Mail: U.S. Department of Agriculture, to it by the Codex Alimentarius to be distributed by the Secretariat Director, Office of Adjudication, 1400 Commission; before the Committee meeting. Members Independence Avenue SW, Washington, (b) Drafting general provisions, as of the public may access or request DC 20250–9410. appropriate, on nutritional aspects of all copies of these documents (see foods and developing standards, ADDRESSES). Fax: (202) 690–7442, Email: guidelines, and related texts for foods [email protected]. for special dietary uses, in cooperation Public Meeting Persons with disabilities who require with other committees where necessary; At the Tuesday, November 6, 2018 alternative means for communication and public meeting, draft U.S. positions on (Braille, large print, audiotape, etc.) (c) Considering, amending if the agenda items will be described and should contact USDA’s TARGET Center necessary, and endorsing provisions on discussed, and attendees will have the at (202) 720–2600 (voice and TDD).

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Done at Washington, DC, on September topics/international-affairs/us-codex- • Considering microbiological risk 14th, 2018. alimentarius/public-meetings. management matters in relation to food Mary Lowe, FOR FURTHER INFORMATION CONTACT: hygiene and in relation to the FAO/ U.S. Manager for Codex Alimentarius. About the 50th Session Of The CCFH: WHO risk assessments. [FR Doc. 2018–20443 Filed 9–19–18; 8:45 am] Jenny Scott, Senior Advisor, Office of The CCFH is hosted by the United BILLING CODE P Food Safety, Center for Food Safety and States. The 50th Session will be co- Applied Nutrition, U.S. Food and Drug hosted by Panama and will convene in Administration, 5001 Campus Drive Panama City. DEPARTMENT OF AGRICULTURE HFS–300, Room 3B–014. College Park, Issues To Be Discussed at the Public MD 20740–3835 Phone: +1 (240) 402– Meeting U.S. Codex Office 2166. Fax: +1 (301) 436–2632. Email: [email protected]. The following items on the Agenda Codex Alimentarius Commission: About the Public Meeting: Barbara for the 50th Session of the CCFH will be Meeting of the Codex Committee on McNiff, U.S. Codex Office, 1400 discussed during the public meeting: Food Hygiene (CCFH) Independence Avenue SW, Room 4861, • Matters referred by the Codex AGENCY: U.S. Codex Office, USDA. South Agriculture Building, Alimentarius Commission and its Washington, DC 20250 Phone: (202) subsidiary bodies to the Food Hygiene ACTION: Notice of public meeting and • request for comments. 690–4719, Fax: (202) 720–3157, Email: Matters arising from the Work of FAO [email protected]. and WHO, including the Joint Expert SUMMARY: The U.S Codex Office is SUPPLEMENTARY INFORMATION: Meeting on Microbiological Risk sponsoring a public meeting on October Assessment (JEMRA) Registration 9, 2018. The objective of the public • Information from the World meeting is to provide information and Attendees may register to attend the Organization for Animal Health (OIE) receive public comments on agenda public meeting by emailing • Proposed draft revision of the General items and draft United States (U.S.) [email protected] by Principles of Food Hygiene (CXC 1– positions to be discussed at the 50th October 3, 2018. Early registration is 1969) and its HACCP Annex session of the Codex Committee on encouraged because it will expedite Æ Comments in reply to CL 2018/69– Food Hygiene (CCFH) of the Codex entry into the building. The meeting FH • Alimentarius Commission in Panama will take place in a Federal building. Revision to the Code of Practice for City, Panama on November 12—16, Attendees should bring photo Fish and Fishery Products (CXC 52– 2018. The U.S. Manager for Codex identification and plan for adequate 2003): Placement for the guidance Alimentarius and the Under Secretary, time to pass through the security on histamine control; amendments Office of Trade and Foreign Agricultural screening systems. Attendees who are to other sections, and revisions to Affairs, recognize the importance of not able to attend the meeting in person, the section on sampling, providing interested parties the but who wish to participate, may do so examination and analyses related to opportunity to obtain background by phone, as discussed above. histamine food safety Æ information on the 50th Session of the Comments in reply to CL 2018/70– Background FH CCFH and to address items on the • agenda. Codex was established in 1963 by two Proposed draft code of practice on United Nations organizations, the Food food allergen management for food DATES: The public meeting is scheduled and Agriculture Organization (FAO) and business operators for Tuesday, October 9, 2018 from 1:00 the World Health Organization (WHO). Æ Comments in reply to CL 2018/71– p.m. to 4 p.m. Through adoption of food standards, FH ADDRESSES: The public meeting will codes of practice, and other guidelines • Proposed draft guidance for the take place at the United States developed by its committees, and by management of (micro) biological Department of Agriculture (USDA), promoting their adoption and foodborne crises/outbreaks Jamie L. Whitten Building, 1400 implementation by governments, Codex Æ Comments in reply to CL 2018/72– Independence Avenue SW, Room 107– seeks to protect the health of consumers FH A, Washington, DC 20250. Documents and ensure fair practices in the food • Discussion paper on future on work related to the 50th Session of the CCFH trade. on Shiga toxin-producing Escherichia will be accessible via the internet at the The CCFH is responsible for: coli (STEC) following address: http:// • Developing basic provisions on • Other business and Future Work www.codexalimentarius.org/meetings- food hygiene, applicable to all food or Æ Proposals in reply to CL 2018/35– reports/en. to specific food types; FH) Jenny Scott, U.S. Delegate to the 50th • Considering and amending or Each issue listed will be fully Session of the CCFH, invites U.S. endorsing provisions on food hygiene described in documents distributed, or interested parties to submit their contained in Codex commodity to be distributed by the Secretariat comments electronically to the standards and codes of practice before the Committee meeting. Members following email address: Jenny.Scott@ developed by Codex commodity of the public may access or request fda.hhs.gov. committees; copies of these documents (see Call-In-Number: If you wish to • Considering specific food hygiene ADDRESSES). participate in the public meeting for the problems assigned to it by the Public Meeting 50th Session of the CCFH by conference Commission; call, please use the call-in-number listed • Suggesting and prioritizing areas At the October 9 public meeting, draft below: where there is a need for U.S. positions on the agenda items will Call-In-Number: 1–888–844–9904. microbiological risk assessment at the be described and discussed, and The participant code will be posted international level and developing attendees will have the opportunity to on the web page below: http:// questions to be addressed by the risk pose questions and offer comments. www.fsis.usda.gov/wps/portal/fsis/ assessors; and Written comments may be offered at the

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meeting or sent to Jenny Scott, U.S. Done at Washington, DC, on September conference call operator will ask callers Delegate for the 50th Session of the 15th, 2018. to provide their names, their CCFH (see ADDRESSES). Written Mary Lowe, organizational affiliations (if any), and comments should state that they relate U.S. Manager for Codex Alimentarius. email addresses (so that callers may be to activities of the 50th Session of the [FR Doc. 2018–20442 Filed 9–19–18; 8:45 am] notified of future meetings). Callers can CCFH. BILLING CODE P expect to incur charges for calls they Additional Public Notification initiate over wireless lines, and the Commission will not refund any Public awareness of all segments of COMMISSION ON CIVIL RIGHTS incurred charges. Callers will incur no rulemaking and policy development is charge for calls they initiate over land- important. Consequently, the U.S. Agenda and Notice of Public Meeting line connections to the toll-free Codex Office will announce this Federal of the Colorado Advisory Committee telephone number provided. Register publication on-line through the AGENCY: Commission on Civil Rights. Persons with hearing impairments FSIS web page located at: http:// ACTION: Announcement of bi-monthly may also follow the discussion by first www.fsis.usda.gov/federal-register. The planning meeting. calling the Federal Relay Service at 1– U.S. Codex Office also offers an email 800–877–8339 and providing the subscription service which provides SUMMARY: Notice is hereby given, operator with the toll-free conference automatic and customized access to pursuant to the provisions of the rules call number: 1–888–395–3237 and and regulations of the U.S. Commission selected food safety news and conference call 1659256. information. This service is available at: on Civil Rights (Commission), and the http://www.fsis.usda.gov/subscribe. Federal Advisory Committee Act Members of the public are invited to Options range from recalls to export (FACA) that a meeting of the Colorado make statements during the open information, regulations, directives, and Advisory Committee to the Commission comment period of the meeting or notices. Customers can add or delete will convene by conference call and submit written comments. The subscriptions themselves, and have the video conference at 2:00 p.m. (EDT) on comments must be received in the option to password protect their Friday, October 5, 2018. The purpose of regional office approximately 30 days accounts. the meeting is to plan for project after each scheduled meeting. Written planning. comments may be mailed to the Rocky USDA Non-Discrimination Statement DATES: Friday, October 5, 2018, at 2:00 Mountain Regional Office, U.S. No agency, officer, or employee of the p.m. (EDT). Commission on Civil Rights, 1961 Stout USDA shall, on the grounds of race, Public Call-In Information: Street, Suite 13–201, Denver, CO 80294, color, national origin, religion, sex, Conference call number: 1–888–395– faxed to (303) 866–1040, or emailed to gender identity, sexual orientation, 3237 and conference call ID: 1659256. Evelyn Bohor at [email protected]. disability, age, marital status, family/ Video Conference Information: Persons who desire additional parental status, income derived from a Joining the meeting using audio and information may contact the Rocky public assistance program, or political visual is a two-step process: For audio, Mountain Regional Office at (303) 866– beliefs, exclude from participation in, dial: 1–888–395–3237; ID: 1659256. For 1040. deny the benefits of, or subject to video: Go to this link to register and join Records and documents discussed the meeting: https://cc.readytalk.com/ discrimination any person in the United during the meeting will be available for registration/#/?meeting= States under any program or activity public viewing as they become available gexk5a8wrwg9&campaign= conducted by the USDA. at https://www.facadatabase.gov/ 1kmq4ekr1j4l. Note: although video How To File a Complaint of conference is available, it is not required committee/meetings.aspx?cid=238; click Discrimination in order to listen to the conference call the ‘‘Meeting Details’’ and ‘‘Documents’’ via audio. links. Records generated from this To file a complaint of discrimination, If you have difficulty with the video meeting may also be inspected and complete the USDA Program link, try a browser other than Explorer reproduced at the Rocky Mountain Discrimination Complaint Form, which or contact ReadyTalk Technical Support Regional Office, as they become may be accessed online at http:// at: 1–800–843–9166. Note: Upon receipt available, both before and after the www.ocio.usda.gov/sites/default/files/ of your registration confirmation email, meeting. Persons interested in the work docs/2012/Complain_combined_6_8_ you will receive a link to test your of this advisory committee are advised 12.pdf, or write a letter signed by you computer before the meeting, it would to go to the Commission’s website, or your authorized representative. be advisable to do so. www.usccr.gov, or to contact the Rocky Send your completed complaint form FOR FURTHER INFORMATION CONTACT: Mountain Regional Office at the above or letter to USDA by mail, fax, or email. Evelyn Bohor, [email protected] or by phone number, email or street address. phone at 303–866–1040. Mail: U.S. Department of Agriculture, Agenda Director, Office of Adjudication, 1400 SUPPLEMENTARY INFORMATION: Interested Independence Avenue SW, Washington, members of the public may listen to the I. Roll Call II. Project Planning DC 20250–9410. discussion by calling the following toll- free conference call number: 1–888– III. Other Business Fax: (202) 690–7442, Email: 395–3237 and conference call ID: IV. Adjournment [email protected]. 1659256; video conference link: https:// Dated: September 17, 2018. Persons with disabilities who require cc.readytalk.com/registration/#/ David Mussatt, alternative means for communication ?meeting=gexk5a8wrwg9&campaign= Supervisory Chief, Regional Programs Unit. (Braille, large print, audiotape, etc.) 1kmq4ekr1j4l. should contact USDA’s TARGET Center Please be advised that, before being [FR Doc. 2018–20498 Filed 9–19–18; 8:45 am] at (202) 720–2600 (voice and TDD). placed into the conference call, the BILLING CODE 6335–01–P

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DEPARTMENT OF COMMERCE sign language interpretation or other Herring PDT, the results from recent auxiliary aids should be directed to Mr. Atlantic herring benchmark stock National Oceanic and Atmospheric Kris Kleinschmidt (kris.kleinschmidt@ assessment and using the acceptable Administration noaa.gov; (503) 820–2411) at least 10 biological catch (ABC) control rule RIN 0648–XG484 days prior to the meeting date. selected by the Council, recommend the Dated: September 17, 2018. overfishing level (OFL) and the ABCs Pacific Fishery Management Council; Tracey L. Thompson, for Atlantic herring for 2019–21. Other Public Meeting business will be discussed as needed. Acting Deputy Director, Office of Sustainable Although non-emergency issues not Fisheries, National Marine Fisheries Service. AGENCY: National Marine Fisheries contained in this agenda may come Service (NMFS), National Oceanic and [FR Doc. 2018–20466 Filed 9–19–18; 8:45 am] before this group for discussion, those Atmospheric Administration (NOAA), BILLING CODE 3510–22–P issues may not be the subject of formal Commerce. action during these meetings. Action ACTION: Notice of public meetings. will be restricted to those issues DEPARTMENT OF COMMERCE specifically listed in this notice and any SUMMARY: The Pacific Fishery issues arising after publication of this Management Council’s (Pacific Council) National Oceanic and Atmospheric Administration notice that require emergency action Ad Hoc Sablefish Management and under section 305(c) of the Magnuson- Trawl Allocation Attainment Committee RIN 0648–XG487 Stevens Act, provided the public has (SaMTAAC) will hold a meeting. been notified of the Council’s intent to New England Fishery Management DATES: The meeting will be held take final action to address the Council; Public Meeting Wednesday, October 10, 2018 and emergency. The public also should be Thursday, October 11, 2018, starting at AGENCY: National Marine Fisheries aware that the meeting will be recorded. 8 a.m. and will end when business for Service (NMFS), National Oceanic and Consistent with 16 U.S.C. 1852, a copy the day has been completed. Atmospheric Administration (NOAA), of the recording is available upon ADDRESSES: The meeting will be held at Commerce request. the Hyatt Place Portland Airport, ACTION: Notice; public meeting. Special Accommodations Meeting Place #3, 9750 NE Cascade Station, Portland, OR 97220; telephone: SUMMARY: The New England Fishery This meeting is physically accessible (503) 288–2808. Management Council (Council) is to people with disabilities. Requests for Council address: Pacific Fishery scheduling a public meeting of its sign language interpretation or other Management Council, 7700 NE Scientific & Statistical Committee to auxiliary aids should be directed to Ambassador Place, Suite 101, Portland, consider actions affecting New England Thomas A. Nies, Executive Director, at OR 97220–1384. fisheries in the exclusive economic zone (978) 465–0492, at least 5 days prior to FOR FURTHER INFORMATION CONTACT: Dr. (EEZ). Recommendations from this the meeting date. Jim Seger, Pacific Council; telephone: group will be brought to the full Council Authority: 16 U.S.C. 1801 et seq. (503) 820–2416. for formal consideration and action, if appropriate. Dated: September 17, 2018. SUPPLEMENTARY INFORMATION: At this Tracey L. Thompson, DATES: This meeting will be held on meeting, the SaMTAAC will continue to Acting Deputy Director, Office of Sustainable develop alternatives that address Wednesday, October 10, 2018 beginning Fisheries, National Marine Fisheries Service. at 9 a.m. obstacles to achieving the goals and [FR Doc. 2018–20467 Filed 9–19–18; 8:45 am] ADDRESSES: objectives of the groundfish trawl catch BILLING CODE 3510–22–P share plan related to under attainment Meeting address: The meeting will be of non-sablefish shore based trawl held at the Hilton Garden Inn, Boston allocations and unharvested sablefish Logan, 100 Boardman Street, Boston, DEPARTMENT OF COMMERCE quota pounds south of 36° N. latitude. MA 02128; phone: (617) 567–6789. The committee’s initial work on Council address: New England National Oceanic and Atmospheric alternatives will be presented at the Fishery Management Council, 50 Water Administration Street, Mill 2, Newburyport, MA 01950. November 2018 Council meeting to RIN 0648–XG486 solicit further Council guidance. FOR FURTHER INFORMATION CONTACT: Although non-emergency issues not Thomas A. Nies, Executive Director, Gulf of Mexico Fishery Management contained in the meeting agenda may be New England Fishery Management Council; Public Meeting discussed, those issues may not be the Council; telephone: (978) 465–0492. subject of formal action during this SUPPLEMENTARY INFORMATION: AGENCY: National Marine Fisheries meeting. Action will be restricted to Service (NMFS), National Oceanic and those issues specifically listed in this Agenda Atmospheric Administration (NOAA), document and any issues arising after The Scientific and Statistical Commerce. publication of this document that Committee will review the results of the ACTION: Notice of a public meeting; via require emergency action under section recent benchmark stock assessment webinar. 305(c) of the Magnuson-Stevens Fishery (SAW/SARC 65) and information Conservation and Management Act, provided by the Council’s Scallop Plan SUMMARY: The Gulf of Mexico Fishery provided the public has been notified of Development Team (PDT). The Management Council will hold a the intent to take final action to address Committee will recommend the meeting of its Mackerel Advisory Panel the emergency. overfishing levels (OFLs) and acceptable via webinar. biological catches (ABCs) for Atlantic DATES: The webinar will convene on Special Accommodations sea scallops for fishing years 2019–20 Tuesday, October 9, 2018, 1 p.m. to 3 The meeting is physically accessible (default). They will also review p.m., EDT. to people with disabilities. Requests for information provided by the Council’s ADDRESSES:

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Meeting address: The meeting will be Dated: September 17, 2018. Protection Act of 1972, as amended held via webinar; visit the Gulf Council Tracey L. Thompson, (MMPA; 16 U.S.C. 1361 et seq.), the website for registration and log in Acting Deputy Director, Office of Sustainable regulations governing the taking and information. Fisheries, National Marine Fisheries Service. importing of marine mammals (50 CFR Council address: Gulf of Mexico [FR Doc. 2018–20465 Filed 9–19–18; 8:45 am] part 216), and the Fur Seal Act of 1966, Fishery Management Council, 4701 W BILLING CODE 3510–22–P as amended (16 U.S.C. 1151 et seq.). Spruce Street, Suite 200, Tampa, FL The proposed permit would authorize 33607; telephone: (813) 348–1630. research to study and monitor FOR FURTHER INFORMATION CONTACT: DEPARTMENT OF COMMERCE population trends, health, and ecology Ryan Rindone, Fishery Biologist, Gulf of of pinnipeds in California. Each year, up National Oceanic and Atmospheric to 2,210 Northern elephant seals Mexico Fishery Management Council; Administration [email protected], (Mirounga angustirostris) and 500 telephone: (813) 348–1630. RIN 0648–XG297 northern fur seal (Callorhinus ursinus) will be tagged, marked, and handled SUPPLEMENTARY INFORMATION: Marine Mammals; File No. 21425 annually. A maximum estimated 4,000 Tuesday, October 9, 2018; 1 p.m.–3 harbor seals (Phoca vitulina), 2,500 AGENCY: National Marine Fisheries p.m.; Northern elephant seals, 2,200 Service (NMFS), National Oceanic and California sea lions (Zalophus I. Introductions and Adoption of Atmospheric Administration (NOAA), californianus), 320 Steller sea lions Agenda (Item A1) Commerce. (Eumetopias jubatus) and 1,250 II. Approval of November 29, 2016 ACTION: Notice; receipt of application. northern fur seals will be incidentally Mackerel AP report minutes (Item disturbed annually during pinniped SUMMARY: Notice is hereby given that A2) research operations including ground Point Blue Conservation Science, has III. Review of CMP Framework surveys, scat collection, unmanned applied in due form for a permit to Amendment 7—Modifications to aircraft system operations, and adult/ conduct research on pinnipeds in Gulf Cobia Size and Possession pup tagging. The permit would be valid California. Limits (Item A3) for five years from date of issuance. IV. CMP FA7 Decision Document (Item DATES: Written, telefaxed, or email In compliance with the National A4) comments must be received on or before Environmental Policy Act of 1969 (42 V. AP Recommendations October 22, 2018. U.S.C. 4321 et seq.), an initial VI. Other Business ADDRESSES: The application and related determination has been made that the —Meeting Adjourns documents are available for review by activity proposed is categorically The meeting will held via webinar. selecting ‘‘Records Open for Public excluded from the requirement to You may register for the webinar by Comment’’ from the ‘‘Features’’ box on prepare an environmental assessment or visiting www.gulfcouncil.org and the Applications and Permits for environmental impact statement. clicking on the Mackerel Advisory Panel Protected Species (APPS) home page, Concurrent with the publication of meeting on the calendar. https://apps.nmfs.noaa.gov, and then this notice in the Federal Register, The Agenda is subject to change, and selecting File No. 21425 from the list of NMFS is forwarding copies of the the latest version along with other available applications. application to the Marine Mammal meeting materials will be posted on These documents are available upon Commission and its Committee of www.gulfcouncil.org as they become written request or by appointment in the Scientific Advisors. available. Permits and Conservation Division, Julia Marie Harrison, Office of Protected Resources, NMFS, Although other non-emergency issues Chief, Permits and Conservation Division, not on the agenda may come before the 1315 East-West Highway, Room 13705, Office of Protected Resources, National Advisory Panel for discussion, in Silver Spring, MD 20910; phone (301) Marine Fisheries Service. accordance with the Magnuson-Stevens 427–8401; fax (301) 713–0376. [FR Doc. 2018–20477 Filed 9–19–18; 8:45 am] Written comments on this application Fishery Conservation and Management BILLING CODE 3510–22–P Act, those issues may not be the subject should be submitted to the Chief, of formal action during this meeting. Permits and Conservation Division, at Actions of the Advisory Panel will be the address listed above. Comments may DEPARTMENT OF COMMERCE restricted to those issues specifically also be submitted by facsimile to (301) identified in the agenda and any issues 713–0376, or by email to National Oceanic and Atmospheric arising after publication of this notice [email protected]. Please Administration that require emergency action under include the File No. in the subject line section 305(c) of the Magnuson-Stevens of the email comment. Marine Mammals and Endangered Fishery Conservation and Management Those individuals requesting a public Species hearing should submit a written request Act, provided the public has been AGENCY: National Marine Fisheries to the Chief, Permits and Conservation notified of the Council’s intent to take Service (NMFS), National Oceanic and Division at the address listed above. The action to address the emergency. Atmospheric Administration (NOAA), request should set forth the specific Commerce. Special Accommodations reasons why a hearing on this ACTION: Notice; issuance of permits. This meeting is physically accessible application would be appropriate. to people with disabilities. Requests for FOR FURTHER INFORMATION CONTACT: Sara SUMMARY: Notice is hereby given that sign language interpretation or other Young or Shasta McClenahan, (301) permits or permit amendments have auxiliary aids should be directed to 427–8401. been issued to the following entities Kathy Pereira at the Gulf Council Office SUPPLEMENTARY INFORMATION: The under the Marine Mammal Protection (see ADDRESSES), at least 5 working days subject permit is requested under the Act (MMPA) and the Endangered prior to the meeting. authority of the Marine Mammal Species Act (ESA), as applicable.

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ADDRESSES: The permits and related FOR FURTHER INFORMATION CONTACT: for a permit or permit amendment had documents are available for review Amy Hapeman (Permit No. 21233), Erin been submitted by the below-named upon written request or by appointment Markin (Permit No. 20561), and Carrie applicants. To locate the Federal in the Permits and Conservation Hubard (Permit No. 22292); at (301) Register notice that announced our Division, Office of Protected Resources, 427–8401. receipt of the application and a NMFS, 1315 East-West Highway, Room complete description of the research, go SUPPLEMENTARY INFORMATION: Notices 13705, Silver Spring, MD 20910; phone: to www.federalregister.gov and search were published in the Federal Register (301) 427–8401; fax: (301) 713–0376. on the permit number provided in the on the dates listed below that requests table below.

Permit or Permit No. RIN Applicant Previous Federal Amendment Register Notice Issuance Date

20561 ...... 0648–XG282 Virginia Aquarium and Marine Science Center (Re- 83 FR 28413; June 19, 8/24/18 sponsible Party: W. Mark Swingle), 717 General 2018. Booth Boulevard, Virginia Beach, VA 23451. 21233 ...... 0648–XG104 NMFS Southeast Fisheries Science Center (Re- 83 FR 13477; March 29, 8/7/18 sponsible Party: Theophilus Brainerd, Ph.D.), 75 2018. Virginia Beach Drive, Miami, FL 33149. 22292 ...... 0648–XG319 Icon Films, (Responsible Party: Laura Marshall), 3rd 83 FR 30916; July 2, 8/3/2018 Floor College House, 32–36 College Green, Bris- 2018. tol, BS1 5SP, United Kingdom.

In compliance with the National DEPARTMENT OF COMMERCE meeting information are located online Environmental Policy Act of 1969 (42 at https://www.fisheries.noaa.gov/topic/ U.S.C. 4321 et seq.), a final National Oceanic and Atmospheric partners#marine-fisheries-advisory- determination has been made that the Administration committee-. The CBP Task Force reports to MAFAC and is being convened to activities proposed are categorically Meeting of the Columbia Basin excluded from the requirement to develop recommendations for long-term Partnership Task Force of the Marine goals to meet Columbia Basin salmon prepare an environmental assessment or Fisheries Advisory Committee environmental impact statement. recovery, conservation needs, and AGENCY: National Marine Fisheries harvest opportunities, in the context of As required by the ESA, as applicable, Service (NMFS), National Oceanic and habitat capacity and other factors that issuance of these permit was based on Atmospheric Administration (NOAA), affect salmon mortality. More a finding that such permits: (1) Were Department of Commerce. information is available at the CBP Task applied for in good faith; (2) will not ACTION: Notice of open public meeting. Force web page: http:// operate to the disadvantage of such www.westcoast.fisheries.noaa.gov/ endangered species; and (3) are SUMMARY: This notice sets forth the columbia_river/index.html. consistent with the purposes and proposed schedule and agenda of a policies set forth in Section 2 of the forthcoming meeting of the Marine Matters To Be Considered ESA. Fisheries Advisory Committee’s The meeting time and agenda are (MAFAC’s) Columbia Basin Partnership Authority: The requested permits have subject to change. Meeting topics Task Force (CBP Task Force). The CBP been issued under the Marine Mammal include continuing to seek agreement on Task Force will discuss the issues Protection Act of 1972, as amended (16 qualitative and quantitative goals for outlined in the SUPPLEMENTARY U.S.C. 1361 et seq.), the regulations Columbia Basin salmon and steelhead, INFORMATION governing the taking and importing of marine below. discussing approaches to integrate the mammals (50 CFR part 216), the Endangered DATES: The meeting will be held information towards developing basin- Species Act of 1973, as amended (ESA; 16 October 2, 2018, from 8 a.m. to 5 p.m. wide goals, and working on the draft U.S.C. 1531 et seq.), and the regulations and on October 3, 2018, from 8 a.m. to recommendations report. The meeting is governing the taking, importing, and 4 p.m. open to the public as observers, and exporting of endangered and threatened ADDRESSES: The meeting will be held at public input will be accepted on species (50 CFR parts 222–226), as the Port of Portland, 7200 NE Airport October 3, 2018, from 1:30 to 2 p.m. applicable. Way, Portland, OR 97218; 503–415– Special Accommodations Dated: September 17, 2018. 6000. The meeting is physically accessible Julia Marie Harrison, FOR FURTHER INFORMATION CONTACT: Katherine Cheney; NFMS West Coast to people with disabilities. Requests for Chief, Permits and Conservation Division, sign language interpretation or other Office of Protected Resources, National Region; 503–231–6730; email: [email protected]. auxiliary aids should be directed to Marine Fisheries Service. Katherine Cheney, 503–231–6730, by SUPPLEMENTARY INFORMATION: Notice is [FR Doc. 2018–20479 Filed 9–19–18; 8:45 am] September 25, 2018. hereby given of a meeting of MAFAC’s BILLING CODE 3510–22–P CBP Task Force. The MAFAC was Dated: September 17, 2018. established by the Secretary of Jennifer L. Lukens, Commerce (Secretary) and, since 1971, Federal Program Officer, Marine Fisheries advises the Secretary on all living Advisory Committee, National Marine marine resource matters that are the Fisheries Service. responsibility of the Department of [FR Doc. 2018–20511 Filed 9–19–18; 8:45 am] Commerce. The MAFAC charter and BILLING CODE 3510–22–P

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COMMODITY FUTURES TRADING SUPPLEMENTARY INFORMATION: The COMMODITY FUTURES TRADING COMMISSION meeting will be open to the public with COMMISSION seating on a first-come, first-served Technology Advisory Committee; basis. Members of the public may also Agency Information Collection Meeting listen to the meeting by telephone by Activities Under OMB Review calling a domestic toll-free telephone or AGENCY: Commodity Futures Trading AGENCY: Commodity Futures Trading international toll or toll-free number to Commission. Commission. connect to a live, listen-only audio feed. ACTION: Notice of meeting. Call-in participants should be prepared ACTION: Notice. SUMMARY: The Commodity Futures to provide their first name, last name, SUMMARY: In compliance with the Trading Commission (CFTC) announces and affiliation. Paperwork Reduction Act of 1995 that on October 5, 2018, from 10:00 a.m. Domestic Toll Free: 1–877–951–7311 (PRA), this notice announces that the to 3:30 p.m., the Technology Advisory International Toll and Toll Free: Will Information Collection Request (ICR) Committee (TAC) will hold a public be posted on the CFTC’s website, http:// abstracted below has been forwarded to meeting in the Conference Center at the www.cftc.gov, on the page for the the Office of Management and Budget CFTC’s Washington, DC, headquarters. meeting, under Related Links. (OMB) for review and comment. The At this meeting, the TAC will hear Pass Code/Pin Code: 5965976 The meeting agenda may change to ICR describes the nature of the presentations and actionable accommodate other TAC priorities. For information collection and its expected recommendations from select TAC agenda updates, please visit the TAC costs and burden. subcommittees (potentially including committee site at: http://www.cftc.gov/ DATES: Comments must be submitted on Automated and Modern Trading About/CFTCCommittees/ or before October 22, 2018. Markets; Distributed Ledger Technology TechnologyAdvisory/tac_meetings. ADDRESSES: Comments regarding the and Market Infrastructure; Virtual After the meeting, a transcript of the burden estimated or any other aspect of Currencies; and Cyber Security meeting will be published through a the information collection, including subcommittees); and discuss how link on the CFTC’s website, http:// suggestions for reducing the burden, RegTech is opening up the possibility of www.cftc.gov. All written submissions may be submitted directly to the Office machine readable and executable provided to the CFTC in any form will of Information and Regulatory Affairs regulatory rulebooks (i.e., Robo also be published on the CFTC’s (OIRA), in OMB, within 30 days of this Rulebooks), as well as the potential role website. Persons requiring special notice’s publication by either of the of regulators. accommodations to attend the meeting following methods. Please identify the DATES: The meeting will be held on because of a disability should notify the comments by ‘‘OMB Control No. 3038– October 5, 2018, from 10:00 a.m. to 3:30 contact person above. 97. p.m. Members of the public who wish • Authority: 5 U.S.C. app. 2, sec. 10(a)(2). By email addressed to: to submit written statements in [email protected] or connection with the meeting should Dated: September 17, 2018. • By mail addressed to: the Office of submit them by October 12, 2018. Christopher Kirkpatrick, Information and Regulatory Affairs, ADDRESSES: The meeting will take place Secretary of the Commission. Office of Management and Budget, in the Conference Center at the CFTC’s [FR Doc. 2018–20508 Filed 9–19–18; 8:45 am] Attention Desk Officer for the headquarters, Three Lafayette Centre, BILLING CODE 6351–01–P Commodity Futures Trading 1155 21st Street NW, Washington, DC Commission, 725 17th Street NW, 20581. You may submit public Washington, DC 20503. comments, identified by ‘‘Technology COMMODITY FUTURES TRADING A copy of all comments submitted to Advisory Committee,’’ by any of the COMMISSION OIRA should be sent to the Commodity following methods: Futures Trading Commission (the • CFTC website: https:// Sunshine Act Meetings ‘‘Commission’’) by any of the following comments.cftc.gov. Follow the methods. The copies should refer to TIME AND DATE: 10:00 a.m., Wednesday, instructions for submitting comments ‘‘OMB Control No. 3038–0097.’’ September 26, 2018. through the Comments Online process • By mail addressed to: Christopher on the website. PLACE: Three Lafayette Centre, 1155 21st Kirkpatrick, Secretary of the • Mail: Christopher Kirkpatrick, Street NW, Washington, DC, 9th Floor Commission, Commodity Futures Secretary of the Commission, Commission Conference Room. Trading Commission, Three Lafayette Commodity Futures Trading STATUS: Closed. Centre, 1155 21st Street NW, Commission, Three Lafayette Center, MATTERS TO BE CONSIDERED: Washington, DC 20581; 1155 21st Street NW, Washington, DC Examinations and enforcement matters. • By Hand Delivery/Courier to the 20581. In the event that the time, date, or same address; or • Hand Delivery/Courier: Same as location of this meeting changes, an • Through the Commission’s website Mail, above. announcement of the change, along with at https://comments.cftc.gov. Please Any statements submitted in the new time, date, and/or place of the follow the instructions for submitting connection with the committee meeting meeting will be posted on the comments through the website. will be made available to the public, Commission’s website at http:// A copy of the supporting statement including publication on the CFTC www.cftc.gov. for the collection of information website, http://www.cftc.gov. CONTACT PERSON FOR MORE INFORMATION: discussed herein may be obtained by FOR FURTHER INFORMATION CONTACT: Christopher Kirkpatrick, 202–418–5964. visiting https://RegInfo.gov. Daniel Gorfine, TAC Designated Federal All comments must be submitted in Officer, Commodity Futures Trading Natise L. Allen, English, or if not, accompanied by an Commission, Three Lafayette Centre, Secretariat Program Assistant. English translation. Comments will be 1155 21st Street NW, Washington, DC [FR Doc. 2018–20540 Filed 9–18–18; 11:15 am] posted as received to https:// 20581; (202) 418–5625. BILLING CODE 6351–01–P www.cftc.gov. You should submit only

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information that you wish to make and provided 60 days for public DEPARTMENT OF DEFENSE available publicly. If you wish the comment on the proposed extension, 83 Commission to consider information FR 31530 (‘‘60-Day Notice’’). The Department of the Army that is exempt from disclosure under the Commission did not receive any [Docket ID: USA–2016–HQ–0038] Freedom of Information Act, a petition relevant comments on the 60-Day for confidential treatment of the exempt Notice. Proposed Collection; Comment information may be submitted according Burden Statement: The respondent Request to the procedures set forth in section 145.9 of the Commission’s regulations.1 burden for this collection is estimated to AGENCY: Department of the Army, DoD. The Commission reserves the right, but be as follows: ACTION: Information collection notice. shall have no obligation, to review, pre- Respondents/Affected Entities: SUMMARY: In compliance with the screen, filter, redact, refuse or remove Derivatives clearing organizations. Paperwork Reduction Act of 1995, the any or all of your submission from Estimated Number of Respondents: Department of the Army announces a https://www.cftc.gov that it may deem to 16. proposed public information collection be inappropriate for publication, such as and seeks public comment on the obscene language. All submissions that Estimated Average Burden Hours per provisions thereof. Comments are have been redacted or removed that Respondent: 40. invited on: whether the proposed contain comments on the merits of the Estimated Total Annual Burden collection of information is necessary ICR will be retained in the public Hours: 640 hours. for the proper performance of the comment file and will be considered as Frequency of Collection: On functions of the agency, including required under the Administrative occasion.3 whether the information shall have Procedure Act and other applicable practical utility; the accuracy of the laws, and may be accessible under the Authority: 44 U.S.C. 3501 et seq. agency’s estimate of the burden of the Freedom of Information Act. Dated: September 17, 2018. proposed information collection; ways FOR FURTHER INFORMATION CONTACT: Robert Sidman, to enhance the quality, utility, and Megan Wallace, Senior Special Counsel, Deputy Secretary of the Commission. clarity of the information to be Division of Clearing and Risk, [FR Doc. 2018–20509 Filed 9–19–18; 8:45 am] collected; and ways to minimize the Commodity Futures Trading BILLING CODE 6351–01–P burden of the information collection on Commission, (202) 418–5150; email: respondents, including through the use [email protected]. of automated collection techniques or SUPPLEMENTARY INFORMATION: other forms of information technology. Title: Part 39, Process for Review of CONSUMER PRODUCT SAFETY DATES: Consideration will be given to all Swaps for Mandatory Clearing (OMB COMMISSION comments received by November 19, Control No. 3038–0097). This is a 2018. request for extension and revision 2 of a Sunshine Act Meetings currently approved information ADDRESSES: You may submit comments, collection. identified by docket number and title, TIME AND DATE: Wednesday, September Abstract: The Commodity Exchange by any of the following methods: 26, 2018, 10:00 a.m.–12:00 p.m. Act and Commission regulations require Federal eRulemaking Portal: http:// www.regulations.gov. Follow the a derivatives clearing organization PLACE: Hearing Room 420, Bethesda instructions for submitting comments. (‘‘DCO’’) that wishes to accept a swap Towers, 4330 East West Highway, Mail: Department of Defense, Office of for clearing to be eligible to clear the Bethesda, MD. the Chief Management Officer, swap and to submit the swap to the STATUS: Directorate for Oversight and Commission for a determination as to Commission Meeting—Open to Compliance, 4800 Mark Center Drive, whether the swap is required to be the Public. Mailbox #24 Suite 08D09, Alexandria, cleared. Commission Regulation 39.5 MATTER TO BE CONSIDERED: Briefing VA 22350–1700. sets forth the process for these Matter: Fiscal Year 2019 Operating Plan. Instructions: All submissions received submissions. The Commission uses the A live webcast of the Meeting can be must include the agency name, docket information in this collection to viewed at https://www.cpsc.gov/live. number and title for this Federal determine whether a DCO that wishes to Register document. The general policy accept a swap for clearing is eligible to CONTACT PERSON FOR MORE INFORMATION : for comments and other submissions clear the swap and whether the swap Rockelle Hammond, Office of the from members of the public is to make should be required to be cleared. Secretariat, Office of the General these submissions available for public An agency may not conduct or Counsel, U.S. Consumer Product Safety viewing on the internet at http:// sponsor, and a person is not required to Commission, 4330 East West Highway, www.regulations.gov as they are respond to, a collection of information Bethesda, MD 20814, (301) 504–6833. received without change, including any unless it displays a currently valid OMB personal identifiers or contact control number. On July 6, 2018, the Dated: September 18, 2018. information. Commission published in the Federal Alberta E. Mills, Register notice of the proposed Secretary. FOR FURTHER INFORMATION CONTACT: To extension of this information collection [FR Doc. 2018–20607 Filed 9–18–18; 4:15 pm] request more information on this proposed information collection or to BILLING CODE 6355–01–P 1 17 CFR 145.9. obtain a copy of the proposal and 2 The total number of respondents has been associated collection instruments, increased from 14 in 2015 to 16 in 2018, based on 3 please write to the Office of the Product the current number of registered DCOs, thus While the 60-Day Notice indicates ‘‘daily, increasing the total annual burden hours from the annual, and on occasion,’’ the frequency of Manager for Force Protection Systems previous 560 hours (40 hrs/response × 14) to 640 information collection is only ‘‘on occasion’’ based (PdM–FPS), 5900 Putnam Road, hours (40 hrs./response × 16) currently. on current data. Building 365/Suite 1, (SFAE–IEW–TF),

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ATTN: Mark Shuler, Fort Belvoir, VA proposed information collection by DoD Dated: September 17, 2018. 22060–5420, or call PdM–FPS at 703– Desk Officer, Docket ID number, and Shelly E. Finke, 704–2402. title of the information collection. Alternate OSD Federal Register, Liaison SUPPLEMENTARY INFORMATION: FOR FURTHER INFORMATION CONTACT: Fred Officer, Department of Defense. Title; Associated Form; and OMB Licari, 571–372–0493, or whs.mc- [FR Doc. 2018–20482 Filed 9–19–18; 8:45 am] Number: Automated Installation Entry alex.esd.mbx.dd-dod-information- BILLING CODE 5001–06–P (AIE) System; OMB Control Number [email protected]. 0702–0125. SUPPLEMENTARY INFORMATION: Needs and Uses: The information DEPARTMENT OF DEFENSE collection requirement is necessary to Title; Associated Form; and OMB verify the identity of an individual and Number: Exceptional Family Member Office of the Secretary determine the fitness of an individual Program (EFMP) Family Needs [Docket ID: DOD–2018–OS–0015] requesting and/or requiring access to Assessment (FNA); DD X768; OMB installations, and issuance of local Control Number 0704–XXXX. Submission for OMB Review; access credentials. The information Type of Request: New collection. Comment Request collection methodology involves the Number of Respondents: 20,000. AGENCY: Office of the Under Secretary of employment of technological collection Responses per Respondent: 1. Defense for Personnel and Readiness, of data via an electronic physical access Annual Responses: 20,000. DoD. control system (PACS) which provides Average Burden per Response: 30 the capability to rapidly and ACTION: 30-day information collection minutes. electronically authenticate credentials notice. and validate and individual’s Annual Burden Hours: 10,000. Needs and Uses: This information SUMMARY: The Department of Defense authorization to enter an installation. has submitted to OMB for clearance the Affected Public: Individuals or collection is necessary to address following proposal for collection of Households; Business or Other For- current differences in assessment information under the provisions of the Profit. processes and inconsistent transfer of Paperwork Reduction Act. Annual Burden Hours: 44,315 Hours. cases across the Services. With this Number of Respondents: 886,294. standardized form, installation-level DATES: Consideration will be given to all Responses per Respondent: 1. EFMP Family Support Offices can comments received by October 22, 2018. Annual Responses: 886,294. provide a family support experience ADDRESSES: Comments and Average Burden per Response: 3 that is consistent across the Services recommendations on the proposed minutes. and maintains continuity of services information collection should be Frequency: On Occasion. when military families with special emailed to Ms. Jasmeet Seehra, DoD _ Dated: September 17, 2018. needs have Permanent Change of Desk Officer, at oira submission@ Shelly E. Finke, Station (PCS) orders to a joint base or omb.eop.gov. Please identify the sister-Service location. proposed information collection by DoD Alternate OSD Federal Register, Liaison Officer, Department of Defense. Affected Public: Individuals or Desk Officer, Docket ID number, and title of the information collection. [FR Doc. 2018–20486 Filed 9–19–18; 8:45 am] Households. FOR FURTHER INFORMATION CONTACT: Fred BILLING CODE 5001–06–P Frequency: On occasion. Respondent’s Obligation: Voluntary. Licari, 571–372–0493, or whs.mc- OMB Desk Officer: Ms. Jasmeet alex.esd.mbx.dd-dod-information- DEPARTMENT OF DEFENSE Seehra. [email protected]. SUPPLEMENTARY INFORMATION: Office of the Secretary You may also submit comments and recommendations, identified by Docket Title; Associated Form; and OMB [Docket ID: DOD–2018–OS–0034] ID number and title, by the following Number: Personnel Security System method: Access Request (PSSAR) Form; DD Submission for OMB Review; Form 2962–1, DD Form 2962–2; OMB • Federal eRulemaking Portal: http:// Comment Request Control Number 0704–0542. www.regulations.gov. Follow the Type of Request: Revision. instructions for submitting comments. AGENCY: Office of the Under Secretary of Number of Respondents: 22,225. Defense for Personnel and Readiness, Instructions: All submissions received Responses per Respondent: 1. DoD. must include the agency name, Docket Annual Responses: 22,225. ACTION: 30-day information collection ID number, and title for this Federal Average Burden per Response: 10 notice. Register document. The general policy minutes. for comments and other submissions Annual Burden Hours: 3,704. SUMMARY: The Department of Defense from members of the public is to make Needs and Uses: The information has submitted to OMB for clearance the these submissions available for public collection requirement is necessary following proposal for collection of viewing on the internet at http:// because the Joint Personnel information under the provisions of the www.regulations.gov as they are Adjudication System, Defense Paperwork Reduction Act. received without change, including any Information System for Security, Secure DATES: Consideration will be given to all personal identifiers or contact Web Fingerprint Transmission, and comments received by October 22, 2018. information. Defense Central Index of Investigations ADDRESSES: Comments and DOD Clearance Officer: Mr. Frederick require personal data collection to recommendations on the proposed Licari. facilitate the granting of access to the information collection should be Requests for copies of the information suite of DMDC systems to Security emailed to Ms. Jasmeet Seehra, DoD collection proposal should be sent to Managers for the purpose of the Desk Officer, at oira_submission@ Mr. Licari at whs.mc-alex.esd.mbx.dd- initiation, investigation and omb.eop.gov. Please identify the [email protected]. adjudication of information relevant to

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DoD security clearances and these submissions available for public ACTION: Arms sales notice. employment suitability determinations viewing on the internet at http:// for active duty military, civilian www.regulations.gov as they are SUMMARY: The Department of Defense is employees and contractors requiring the received without change, including any publishing the unclassified text of an aforementioned clearances. As a suite of personal identifiers or contact arms sales notification. Personnel Security Systems, they are the information. authoritative source for clearance DOD Clearance Officer: Mr. Frederick FOR FURTHER INFORMATION CONTACT: information resulting in accesses Licari. DSCA at dsca.ncr.lmo.mbx.info@ determinations to sensitive/classified Requests for copies of the information mail.mil or (703) 697–9709. collection proposal should be sent to information and facilities. SUPPLEMENTARY INFORMATION: This Mr. Licari at whs.mc-alex.esd.mbx.dd- Affected Public: Business or other for- 36(b)(1) arms sales notification is profit. [email protected]. published to fulfill the requirements of Frequency: As required. Dated: September 17, 2018. section 155 of Public Law 104–164 Respondent’s Obligation: Voluntary. Shelly E. Finke, OMB Desk Officer: Ms. Jasmeet dated July 21, 1996. The following is a Alternate OSD Federal Register, Liaison copy of a letter to the Speaker of the Seehra. Officer, Department of Defense. You may also submit comments and House of Representatives, Transmittal [FR Doc. 2018–20485 Filed 9–19–18; 8:45 am] recommendations, identified by Docket 18–27 with attached Policy Justification ID number and title, by the following BILLING CODE 5001–06–P and Sensitivity of Technology. method: Dated: September 17, 2018. • Federal eRulemaking Portal: http:// DEPARTMENT OF DEFENSE Shelly E. Finke, www.regulations.gov. Follow the Alternate OSD Federal Register Liaison instructions for submitting comments. Office of the Secretary Instructions: All submissions received Officer, Department of Defense. must include the agency name, Docket [Transmittal No. 18–27] BILLING CODE 5001–06–P ID number, and title for this Federal Arms Sales Notification Register document. The general policy for comments and other submissions AGENCY: Defense Security Cooperation from members of the public is to make Agency, Department of Defense.

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BILLING CODE 5001–06–C Total ...... $169 million Exercise Section (FES) and fuel tanks; Transmittal No. 18–27 (iii) Description and Quantity or air launch accessories for rotary wing aircraft; torpedo launcher interface Notice of Proposed Issuance of Letter of Quantities of Articles or Services under cabinets; ground handling equipment; Offer Pursuant to Section 36(b)(1) of the Consideration for Purchase: Arms Export Control Act, as amended Major Defense Equipment (MDE): torpedo spare parts; training; publications; support and test (i) Prospective Purchaser: The One hundred six (106) MK 54 Lightweight Torpedo Conversion Kits equipment; U.S. Government and Government of the Netherlands contractor engineering, technical, and (ii) Total Estimated Value: Non-MDE: logistics support services; and other Also included are torpedo containers, Major Defense Equipment * $122 million related elements of logistics and Other ...... $ 47 million Recoverable Exercise Torpedoes (REXTORP) with containers; Fleet program support.

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(iv) Military Department: Navy (NE– Transmittal No. 18–27 ACTION: Information collection notice. P–LHP) Notice of Proposed Issuance of Letter of (v) Prior Related Cases, if any: None SUMMARY: In compliance with the Offer Pursuant to Section 36(b)(1) of the Paperwork Reduction Act of 1995, the (vi) Sales Commission, Fee, etc., Paid, Arms Export Control Act Office of Civilian Human Resources Offered, or Agreed to be Paid: None Annex Item No. vii announces a proposed public (vii) Sensitivity of Technology information collection and seeks public Contained in the Defense Article or (vii) Sensitivity of Technology: 1. The MK 54 Torpedo is a comment on the provisions thereof. Defense Services Proposed to be Sold: conventional torpedo that can be Comments are invited on: Whether the None launched from surface ships, proposed collection of information is (viii) Date Report Delivered to helicopters, and fixed wing aircraft. The necessary for the proper performance of Congress: July 31, 2018 MK 54 is an upgrade to the MK 46 the functions of the agency, including * As defined in Section 47(6) of the Torpedo, which is currently in-service whether the information shall have Arms Export Control Act. in Netherlands. The upgrade to the MK practical utility; the accuracy of the agency’s estimate of the burden of the POLICY JUSTIFICATION 54 entails replacement of the torpedo’s sonar and guidance and control systems proposed information collection; ways The Netherlands—MK 54 Lightweight with modem technology. The new to enhance the quality, utility, and Torpedoes guidance and control system uses a clarity of the information to be collected; and ways to minimize the The Netherlands requests to buy one mixture of commercial-off-the-shelf and burden of the information collection on hundred six (106) MK 54 conversion custom-built electronics. The warhead, respondents, including through the use kits. Also included are torpedo fuel tank and propulsion system from of automated collection techniques or containers, Recoverable Exercise the MK 46 torpedo are re-used in the other forms of information technology. Torpedoes (REXTORP) with containers; MK 54 configuration with minor Fleet Exercise Section (FES) and fuel modifications. There is no sensitive DATES: Consideration will be given to all tanks; air launch accessories for rotary technology in the MK 54 or its support comments received by November 19, wing aircraft; torpedo launcher interface and test equipment. The assembled MK 2018. cabinets; ground handling equipment; 54 torpedo and several of its individual components are classified ADDRESSES: You may submit comments, torpedo spare parts; training; identified by docket number and title, publications; support and test CONFIDENTIAL. The MK 54 operational software is classified as by any of the following methods: equipment; U.S. Government and Federal eRulemaking Portal: http:// contractor engineering, technical, and SECRET. Netherlands will not be provided with the source code for the www.regulations.gov. Follow the logistics support services; and other instructions for submitting comments. related elements of logistics and MK 54 operational software. 2. If a technologically advanced Mail: Department of Defense, Office of program support. The estimated adversary were to obtain knowledge of the Chief Management Officer, program value is $169 million. the hardware and software elements, the Directorate for Oversight and This proposed sale will support the information could be used to develop Compliance, 4800 Mark Center Drive, foreign policy and national security countermeasures or equivalent systems Mailbox #24 Suite 08D09, Alexandria, objectives of the United States by which might reduce system VA 22350–1700. improving the security of a NATO Ally, effectiveness or be used in the Instructions: All submissions received which is an important force for political development of a system with similar or must include the agency name, docket stability and economic progress in advanced capabilities. number and title for this Federal Europe. 3. A determination has been made Register document. The general policy The Royal Netherlands Navy intends that the Government of the Netherlands for comments and other submissions to upgrade its current MK 46 torpedoes can provide substantially the same from members of the public is to make to the MK 54 with the purchase of these degree of protection for the sensitive these submissions available for public kits. The Netherlands will have no technology being released as the U.S. viewing on the internet at http:// difficulty absorbing the MK 54 Government. This sale is necessary in www.regulations.gov as they are torpedoes. furtherance of the U.S. foreign policy received without change, including any The proposed sale of this equipment and national security objectives personal identifiers or contact and support will not alter the basic outlined in the Policy Justification. information. military balance in the region. 4. All defense articles and services FOR FURTHER INFORMATION CONTACT: To The principal contractor will be listed in this transmittal have been request more information on this Raytheon Integrated Defense System, authorized for release and export to the proposed information collection or to Portsmouth, Rhode Island. There are no Netherlands. obtain a copy of the proposal and known offset agreements proposed in [FR Doc. 2018–20507 Filed 9–19–18; 8:45 am] associated collection instruments, connection with this potential sale. BILLING CODE 5001–06–P please write to Office of the Assistant Implementation of this proposed sale Secretary of the Navy, Office of Civilian will not require the assignment of any Human Resources (ASN/OCHR), 614 additional U.S. Government or DEPARTMENT OF DEFENSE Sicard Street, Building 201, Washington, DC 20374 or call OCHR at contractor representatives to Department of the Navy Netherlands; however, U.S. Government [202–685–6466]. Engineering and Technical Services may [Docket ID: USN–2018–HQ–0015] SUPPLEMENTARY INFORMATION: be required on an interim basis for Title; Associated Form; and OMB installations and integration. Proposed Collection; Comment Request Number: Department of the Navy (DON) There will be no adverse impact on Reasonable Accommodations (RA) U.S. defense readiness as a result of this AGENCY: Office of the Assistant Tracker; SECNAV Form 12306/1T proposed sale. Secretary of the Navy, DoD. Confirmation of Reasonable

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Accommodation Request; OMB Control Dated: September 17, 2018. DEPARTMENT OF EDUCATION Number 0703–0063. Shelly E. Finke, [Docket No.: ED–2018–ICCD–0099] Needs and Uses: The information Alternate OSD Federal Register, Liaison collection requirement is necessary to Officer, Department of Defense. Agency Information Collection track, monitor, review, and process [FR Doc. 2018–20489 Filed 9–19–18; 8:45 am] Activities; Comment Request; requests for reasonable accommodation BILLING CODE 5001–06–P Borrower Defenses Against Loan applicants for employment. This Repayment information will be collected by DON AGENCY: Federal Student Aid (FSA), EEO personnel involved in the DEPARTMENT OF DEFENSE Department of Education (ED). Reasonable Accommodation process and input data into the Reasonable Department of the Navy ACTION: Notice. Accommodation Tracker (electronic SUMMARY: In accordance with the information system) pursuant to [Docket ID USN–2018–HQ–0014] Paperwork Reduction Act of 1995, ED is Executive Order 13163. Official proposing an extension of an existing Reasonable Accommodation case files Privacy Act of 1974; System of information collection. are secured with access granted on a Records; Correction DATES: Interested persons are invited to strictly limited basis. submit comments on or before AGENCY: Affected Public: Individuals or Department of the Navy, DoD. November 19, 2018. Households. ACTION: Notice of a modified system of ADDRESSES: To access and review all the Annual Burden Hours: 33. records; correction. documents related to the information collection listed in this notice, please Number of Respondents: 100. SUMMARY: On September 5, 2018, the use http://www.regulations.gov by Responses per Respondent: 1. Department of Defense published a searching the Docket ID number ED– Annual Responses: 100. system of records notice that proposed 2018–ICCD–0099. Comments submitted in response to this notice should be Average Burden per Response: 20 to modify Family and Unaccompanied submitted electronically through the minutes. Housing Program, NM11101–1. Subsequent to the publication of the Federal eRulemaking Portal at http:// Frequency: On occasion. notice, DoD discovered that the system www.regulations.gov by selecting the The Department of the Navy number had published incorrectly. This Docket ID number or via postal mail, Reasonable Accommodation Tracker notice corrects that error. commercial delivery, or hand delivery. will maintain employment information, Please note that comments submitted by contact information, and information DATES: This correction is applicable on fax or email and those submitted after related to the disabilities and reasonable September 20, 2018. the comment period will not be accepted. Written requests for accommodations/potential reasonable FOR FURTHER INFORMATION CONTACT: information or comments submitted by accommodations for employees, Patricia Toppings, 571–372–0485. contractors, and applicants for postal mail or delivery should be employment who request reasonable SUPPLEMENTARY INFORMATION: addressed to the Director of the Information Collection Clearance accommodations. Reasonable Correction accommodations applicants complete Division, U.S. Department of Education, SECNAV 12306/1T Form-Confirmation On September 5, 2018 (83 FR 45112– 550 12th Street SW, PCP, Room 9086, of Reasonable Accommodation Request, 45115), the Department of Defense Washington, DC 20202–0023. information from the form will be input published a system of records notice, FR FOR FURTHER INFORMATION CONTACT: For into the Reasonable Accommodation Doc. 2018–19204, that proposed to specific questions related to collection Tracker. Contact information of modify Family and Unaccompanied activities, please contact Beth deciding officials and health care Housing Program, NM11101–1. Grebeldinger, 202–377–4018. providers will also be maintained in the Subsequent to the publication of the SUPPLEMENTARY INFORMATION: The system. Data collected is required for notice, DoD discovered that the system Department of Education (ED), in DON EEO officials and employees to name had published incorrectly. The accordance with the Paperwork track, monitor, review, and process Reduction Act of 1995 (PRA) (44 U.S.C. system name incorrectly published as requests for reasonable 3506(c)(2)(A)), provides the general ‘‘NM1110–01’’ in the two places it accommodations. Individuals involved public and Federal agencies with an appeared in the notice. The system in the reasonable accommodation opportunity to comment on proposed, process would not be able to perform name is corrected as follows: revised, and continuing collections of their official duties of processing or 1. On page 45112, in the first column, in information. This helps the Department deciding on cases if the subject the SUMMARY paragraph, ‘‘NM1110–01’’ is assess the impact of its information information is not collected and corrected to read ‘‘NM11101–1.’’ collection requirements and minimize maintained by DON EEO personnel. 2. On page 45112, in the third column, in the public’s reporting burden. It also Official Reasonable Accommodation the SYSTEM NAME AND NUMBER helps the public understand the case files are secured with access paragraph, ‘‘NM1110–01’’ is corrected to read Department’s information collection granted on a strictly limited basis. Case ‘‘NM11101–1.’’ requirements and provide the requested files will be retained for the duration of Dated: September 17, 2018. data in the desired format. ED is that individual’s employment with the Aaron T. Siegel, soliciting comments on the proposed Department of the Navy. Case files information collection request (ICR) that maintained will be retained and Alternate OSD Federal Register Liaison is described below. The Department of Officer, Department of Defense. disposed of in accordance with the Education is especially interested in provisions of the OPM Government [FR Doc. 2018–20513 Filed 9–19–18; 8:45 am] public comment addressing the wide Systems of Records, 65 CFR 27432. BILLING CODE 5001–06–P following issues: (1) Is this collection

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necessary to the proper functions of the of a student loan. There is no change to government in the Sunshine Act (Pub. Department; (2) will this information be statutory or regulatory requirements. L. 94–409), 5 U.S.C. 552b: processed and used in a timely manner; This collection continues to be AGENCY HOLDING MEETING: Federal (3) is the estimate of burden accurate; necessary to ensure Heald, Everest and/ Energy Regulatory Commission. (4) how might the Department enhance or WyoTech College borrowers who the quality, utility, and clarity of the wish to invoke the borrower defense TIME AND DATE: September 20, 2018 information to be collected; and (5) how against repayment of federal student 10:00 a.m. might the Department minimize the loans can do so in a uniform and PLACE: burden of this collection on the informed manner. It will also allow for Room 2C, 888 First Street NE, respondents, including through the use the uniform and directed collection of Washington, DC 20426. of information technology. Please note minimum borrower defense information STATUS: Open. that written comments received in from other federal student loan response to this notice will be borrowers that attended the school who MATTERS TO BE CONSIDERED: Agenda considered public records. believe they can provide evidence of Note: Items listed on the agenda may be Title of Collection: Borrower Defenses such an application for loan forgiveness. deleted without further notice. Against Loan Repayment. Dated: September 17, 2018. OMB Control Number: 1845–0132. CONTACT PERSON FOR MORE INFORMATION: Kate Mullan, Type of Review: An extension of an Kimberly D. Bose, Secretary, Telephone Acting Director, Information Collection existing information collection. (202) 502–8400. Respondents/Affected Public: Clearance Division, Office of the Chief Privacy Officer, Office of Management. For a recorded message listing items Individuals or Households. struck from or added to the meeting, call Total Estimated Number of Annual [FR Doc. 2018–20456 Filed 9–19–18; 8:45 am] (202) 502–8627. Responses: 150,000. BILLING CODE 4000–01–P Total Estimated Number of Annual This is a list of matters to be Burden Hours: 150,000. considered by the Commission. It does Abstract: This is a request for an DEPARTMENT OF ENERGY not include a listing of all documents extension of the current information relevant to the items on the agenda. All collection for Form 1845–0132. The U.S. Federal Energy Regulatory public documents, however, may be Department of Education continues to Commission viewed on line at the Commission’s require the collection of this Sunshine Act Meetings website at http://ferc.capitol information from borrowers who believe connection.org/ using the eLibrary link, they have cause to invoke the borrower The following notice of meeting is or may be examined in the defense to loan repayment forgiveness published pursuant to section 3(a) of the Commission’s Public Reference Room.

1047TH—MEETING [Open Meeting September 20, 2018 10:00 p.m.]

Item No. Docket No. Company

ADMINISTRATIVE

A–1 ...... AD18–2–000 ...... Customer Matters, Reliability, Security and Market Operations. A–2 ...... AD18–1–000 ...... Agency Administrative Matters. A–3 ...... AD18–17–000 ...... Memorandum of Understanding Between the Department of Transportation and the Federal Energy Regulatory Commission Regarding Liquefied Natural Gas Trans- portation Facilities.

ELECTRIC

E–1 ...... EL18–152–000 ...... Louisiana Public Service Commission v. System Energy Resources, Inc. and Entergy Services, Inc. E–2 ...... EL16–120–002 ...... New England Power Generators Association, Inc. v. ISO New England Inc. ER17–2153–002 ...... ISO New England. Inc. ER18–1153–000 ...... ISO New England, Inc. E–3 ...... ER10–1791–004 ...... Midwest Independent Transmission System Operator, Inc. E–4 ...... ER17–2073–001 ...... PJM Interconnection, L.L.C. E–5 ...... ER17–2267–001 ...... PJM Interconnection, L.L.C. E–6 ...... ER14–2154–006 ...... Midcontinent Independent System Operator, Inc. ER15–277–005 (consolidated) E–7 ...... EL17–44–000 ...... Northern States Power Company, Minnesota. E–8 ...... EL18–145–000 ...... Tilton Energy LLC v. PJM Interconnection, L.L.C. E–9 ...... ER14–1409–000 ...... ISO New England Inc. E–10 ...... EL18–131–000 ...... Nevada Hydro Company, Inc. E–11 ...... ER17–1750–002 ...... Pacific Gas and Electric Company.

GAS

G–1 ...... OMITTED. G–2 ...... OMITTED. G–3 ...... OR18–7–000 ...... Epsilon Trading, LLC, Chevron Products Company, and Valero Marketing and Sup- ply Company v. Colonial Pipeline Company.

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1047TH—MEETING—Continued [Open Meeting September 20, 2018 10:00 p.m.]

Item No. Docket No. Company

OR18–12–000 ...... BP Products North America, Inc., Trafigura Trading LLC, and TCPU, Inc. v. Colo- nial Pipeline Company. OR18–17–000 ...... TransMontaigne Product Services LLC v. Colonial Pipeline Company. OR18–21–000 ...... CITGO Petroleum Corporation v. Colonial Pipeline Company. (consolidated) ......

HYDRO

H–1 ...... EL18–56–000 ...... Utah Board of Water Resources. P–12966–005 ...... H–2 ...... P–2611–087 ...... Hydro-Kennebec LLC.

CERTIFICATES

C–1 ...... CP09–465–002 ...... Northern Natural Gas Company. C–2 ...... CP17–219–000 ...... Southern Star Central Gas Pipeline, Inc.

Issued: September 13, 2018. MATTERS TO BE CONSIDERED: Compliance Print submissions: Kimberly D. Bose, matters pursuant to 52 U.S.C. 30109. Mailing Address: Center for Evidence Secretary. Matters concerning participation in civil and Practice Improvement, Agency for actions or proceedings or arbitration. A free webcast of this event is Healthcare Research and Quality, available through http:// * * * * * ATTN: EPC SEADs Coordinator, 5600 ferc.capitolconnection.org/. Anyone CONTACT PERSON FOR MORE INFORMATION: Fishers Lane, Mail Stop 06E53A, with internet access who desires to view Judith Ingram, Press Officer, Telephone: Rockville, MD 20857. this event can do so by navigating to (202) 694–1220. Shipping Address (FedEx, UPS, etc.): Center for Evidence and Practice www.ferc.gov’s Calendar of Events and Laura E. Sinram, locating this event in the Calendar. The Improvement, Agency for Healthcare Deputy Secretary of the Commission. event will contain a link to its webcast. Research and Quality, ATTN: EPC The Capitol Connection provides [FR Doc. 2018–20632 Filed 9–18–18; 4:15 pm] SEADs Coordinator, 5600 Fishers Lane, technical support for the free webcasts. BILLING CODE 6715–01–P Mail Stop 06E77D, Rockville, MD It also offers access to this event via 20857. television in the DC area and via phone bridge for a fee. If you have any DEPARTMENT OF HEALTH AND FOR FURTHER INFORMATION CONTACT: questions, visit http:// HUMAN SERVICES Jenae Benns, Telephone: 301–427–1496 ferc.capitolconnection.org/ or contact or Email: [email protected]. Agency for Healthcare Research and Danelle Springer or David Reininger at SUPPLEMENTARY INFORMATION: The Quality 703–993–3100. Agency for Healthcare Research and Immediately following the conclusion Supplemental Evidence and Data Quality has commissioned the of the Commission Meeting, a press Request on Depression in Children: Evidence-based Practice Centers (EPC) briefing will be held in the Commission Systematic Review Program to complete a review of the Meeting Room. Members of the public evidence for Depression in Children: may view this briefing in the designated AGENCY: Agency for Healthcare Research Systematic Review. AHRQ is conducting overflow room. This statement is and Quality (AHRQ), HHS. this systematic review pursuant to intended to notify the public that the ACTION: Request for Supplemental Section 902(a) of the Public Health press briefings that follow Commission Evidence and Data Submissions. Service Act, 42 U.S.C. 299a(a). The EPC meetings may now be viewed remotely Program is dedicated to identifying as at Commission headquarters, but will SUMMARY: The Agency for Healthcare many studies as possible that are not be telecast through the Capitol Research and Quality (AHRQ) is seeking relevant to the questions for each of its Connection service. scientific information submissions from reviews. In order to do so, we are [FR Doc. 2018–20619 Filed 9–18–18; 4:15 pm] the public. Scientific information is supplementing the usual manual and BILLING CODE 6717–01–P being solicited to inform our review of electronic database searches of the Depression in Children: Systematic literature by requesting information Review, which is currently being from the public (e.g., details of studies FEDERAL ELECTION COMMISSION conducted by the AHRQ’s Evidence- conducted). We are looking for studies based Practice Centers (EPC) Program. that report on Depression in Children: Sunshine Act Meetings Access to published and unpublished Systematic Review, including those that pertinent scientific information will describe adverse events. The entire TIME AND DATE: Tuesday, September 25, improve the quality of this review. research protocol, including the key 2018 at 10:00 a.m. DATES: Submission Deadline on or questions, is also available online at: PLACE: 1050 First Street NE, before October 22, 2018. https://effectivehealthcare.ahrq.gov/ Washington, DC. ADDRESSES: topic/childhood-depression/protocol STATUS: This Meeting will be Closed to Email submissions: epc@ This is to notify the public that the the Public. ahrq.hhs.gov. EPC Program would find the following

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information on Depression in Children: are considered confidential; marketing characteristics, disorder characteristics, Systematic Review helpful: materials; study types not included in history of previous treatment, comorbid • A list of completed studies that the review; or information on condition, exposure to a traumatic life your organization has sponsored for this indications not included in the review event? indication. In the list, please indicate cannot be used by the EPC Program. 3a. In adolescents and children, what whether results are available on This is a voluntary request for are the benefits and harms of ClinicalTrials.gov along with the information, and all costs for complying combination interventions for ClinicalTrials.gov trial number. with this request must be borne by the depressive disorders (defined as MDD or • For completed studies that do not submitter. PDD/DD)? The draft of this review will be posted have results on ClinicalTrials.gov, 3b. How do the benefits and harms on AHRQ’s EPC Program website and please provide a summary, including vary by subpopulation (e.g., patient the following elements: Study number, available for public comment for a period of 4 weeks. If you would like to characteristics, disorder characteristics, study period, design, methodology, history of previous treatment, comorbid indication and diagnosis, proper use be notified when the draft is posted, please sign up for the email list at: condition, exposure to a traumatic life instructions, inclusion and exclusion event)? criteria, primary and secondary https:// 4a: In adolescents and children, what outcomes, baseline characteristics, www.effectivehealthcare.ahrq.gov/ are the benefits and harms of number of patients screened/eligible/ email-updates. collaborative care interventions for enrolled/lost to follow-up/withdrawn/ The systematic review will answer the depressive disorders (defined as MDD or analyzed, effectiveness/efficacy, and following questions. This information is PDD/DD)? safety results. provided as background. AHRQ is not • A list of ongoing studies that your requesting that the public provide 4b: How do the benefits and harms answers to these questions. organization has sponsored for this vary by subpopulation (e.g., patient The Key Questions (KQs) indication. In the list, please provide the characteristics, disorder characteristics, 1a. In adolescents and children, what history of previous treatment, comorbid ClinicalTrials.gov trial number or, if the are the benefits and harms of trial is not registered, the protocol for condition, exposure to a traumatic life nonpharmacological interventions for event)? the study including a study number, the depressive disorders (defined as MDD or 5a: In adolescents and children, what study period, design, methodology, PDD/DD)? indication and diagnosis, proper use 1b. How do these benefits and harms are the comparative benefits and harms instructions, inclusion and exclusion vary by subpopulation (e.g., patient of treatments (pharmacological, criteria, and primary and secondary characteristics, parent/caregiver nonpharmacological, combined, outcomes. characteristics, disorder characteristics, collaborative care interventions) for • Description of whether the above history of previous treatment, comorbid depressive disorders (defined as MDD or studies constitute ALL Phase II and condition, exposure to a traumatic life PDD/DD)? above clinical trials sponsored by your event)? 5b. How do these benefits and harms organization for this indication and an 2a. In adolescents and children, what vary by subpopulation (e.g., patient index outlining the relevant information are the benefits and harms of characteristics, disorder characteristics, in each submitted file. pharmacological interventions for history of previous treatment, comorbid Your contribution will be very depressive disorders (defined as MDD or condition, exposure to a traumatic life beneficial to the EPC Program. Materials PDD/DD)? event)?PICOTS (Populations, submitted must be publicly available or 2b. How do the benefits and harms Interventions, Comparators, Outcomes, able to be made public. Materials that vary by subpopulation (e.g., patient Timing, Settings)

TABLE 1—PICOTS (POPULATIONS, INTERVENTIONS, COMPARATORS, OUTCOMES, TIMING, SETTINGS) AND INCLUSION/ EXCLUSION CRITERIA

PICOTS Inclusion Exclusion

Population ...... Children and adolescents (≤18 years old) with a depressive disorder All other children and adolescents (MDD or PDD/DD) as indicated by a diagnosis made from an es- (≤18 years old); all adults >18 tablished taxonomy (e.g., DSM, ICD) via administration of a struc- years old. tured or semi-structured clinical interview (CIDI, DISC, SCID, PRIME–MD, Kinder-DIPS, K–SADS, DICA, CAS, SADS, DAWBA, SCAN), use of a cutpoint indicative of clinical MDD or PDD/DD as measured by a clinically validated depression scale (BDI, CDI, CESD, PHQ, MFQ, ChilD–S),* or via a clinician diagnosis. Subgroups of interest (KQs 1b, 2b, 3b, 4b, 5b) include those distin- guished by patient characteristics (e.g., developmental age—child or adolescent, gender, race/ethnicity), parent/caregiver characteris- tics, disorder characteristics (e.g., type, severity), history of pre- vious treatment, comorbid condition, and exposure to a traumatic life event. Intervention ...... Nonpharmacological interventions: ...... All other interventions. Psychological/psychosocial: Cognitive behavioral therapy, rational emotive behavior therapy, behavioral activation, other behavioral therapy, interpersonal therapy, directive counseling, Katathym- imaginative Psychotherapy, family therapy, parent education, self- help groups, problem-solving therapy, autonomic training, com- bined-modality therapy, psychological adaptation therapies.

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TABLE 1—PICOTS (POPULATIONS, INTERVENTIONS, COMPARATORS, OUTCOMES, TIMING, SETTINGS) AND INCLUSION/ EXCLUSION CRITERIA—Continued

PICOTS Inclusion Exclusion

Lifestyle: Exercise (physical activity), diet therapy, mindfulness (in- cluding mindfulness-based stress reduction), meditation (including mindfulness mediation), relaxation therapy, massage therapy, music therapy, art therapy, integrative restoration, visualization, tai- chi, yoga, spirituality, acupuncture. Supplements: St. John’s Wort, SAMe, fish oil, melatonin, L-trypto- phan, folic acid, 5–HTP, zinc, chromium, gingko biloba, vitamin E, omega-3 fatty acids, hypericum, inositol, selenium. Other: Electroconvulsive therapy, transcranial magnetic stimulation, light therapy (phototherapy), hypnotherapy (including self-hypno- therapy), neurofeedback, deep brain stimulation, biofeedback. Pharmacological interventions:. Selective serotonin reuptake inhibitors (SSRIs): Citalopram, escitalopram, fluvoxamine, paroxetine, sertraline, vilazodone. Serotonin and norepinephrine reuptake inhibitors (SNRIs): Duloxetine, venlafaxine. Tricyclic antidepressants: Amitriptyline, desipramine, imipramine, nortriptyline, doxepin, clomipramine. Monoamine oxidase inhibitors: Rasagiline, selegiline, isocarboxazid, phenelzine, tranylcypromine. Atypical antidepressants: Bupropion, mirtazapine, nefazodone, trazodone, vortioxetine. Combination interventions: Any combined treatment that includes two or more types of nonpharmacological, pharmacological, and/or col- laborative care interventions, either started together or given as augments to initial treatment types. Collaborative care interventions: Collaborative care, integrated care, integrative care, stepped care, coordinated care, co-managed care, co-located care. Comparator ...... KQ 1: Treatment as usual, sham, attention control, wait list control .... All other comparators. KQ 2: Placebo, treatment as usual, attention control, wait list control. KQ 3: Treatment as usual, placebo, sham, attention control, wait list control. KQ 4: Treatment as usual, placebo, sham, attention control, wait list control. KQ 5: Any nonpharmacologic, pharmacologic, or collaborative care intervention alone or in combination. Outcomes **** ...... Benefits: ...... All other outcomes. Remission. Response. Relapse. Depressive symptoms. Suicidality. Mortality. Functional impairment. Harms: ...... Any AEs of intervention (e.g., death, serious adverse events). Time frame ...... Any publication dates ...... Less than 6 weeks of treatment. At least 6 weeks of treatment. Settings ...... Outpatient care in countries with a very high Human Development Inpatient care, studies conducted Index **. in countries without a very high Human Development Index. Study design ...... For benefits: ...... All other designs and studies • Adolescents (sample age >12 and ≤18): randomized controlled using included designs that do trials (RCTs). not meet the sample size cri- • Children (sample age ≤12): RCTs or controlled clinical trials terion. (CCTs). For harms: • RCTs, CCTs, and observational studies ***. Reference lists of relevant systematic reviews published in 2013 or later will be used to ensure our search strategies captured all rel- evant studies. Language ...... Studies published in English ...... Studies published in languages other than English. * In the absence of clear, clinically validated cutoffs of depression scales used to indicate a either MDD or PDD/DD, the research team will consult two recent systematic reviews 12 on the topic and discuss required thresholds with the Technical Expert Panel (TEP) for each scale. ** http://hdr.undp.org/en/content/human-development-index-hdi. *** The research team will evaluate the yield for harms. When studies with sample sizes of 1,000 or more participants are available for a given intervention and comparator, the team plans to restrict the analysis to that group. If large samples are not available, the team plans to include studies with smaller sample sizes.

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**** The research team anticipates grading all outcomes but if needed (based on the volume of evidence), they may seek input from the TEP on prioritizing outcomes for strength of evidence grading. AE = adverse event; BDI = Beck Depression Inventory; CAS: The Child Assessment Schedule; CBT = cognitive behavioral therapy; CCT = controlled clinical trial; CIDI = Composite International Diagnostic Interview; CDI = Children’s Depression Inventory; CES–D = Center for Epide- miological Studies Depression Scale; ChilD–S: Children’s Depression Screener; DAWBA = The Development and Wellbeing Assessment; DD = dysthymic disorder; DICA = Diagnostic Interview for Children and Adolescents; DISC = Diagnostic Interview Schedule for Children; DSM = Diag- nostic and Statistical Manual; IPT = interpersonal therapy; Kinder-DIPS = The Diagnostic Interview for Psychiatric Disorders in Children and Ado- lescents; K–SADS = The Schedule for Affective Disorders and Schizophrenia for School-Age Children; MDD = major depressive disorder; MFQ = Mood and Feelings Questionnaire; PDD = persistent depressive disorder; PHQ = Patient Health Questionnaire; PICOTS = populations, interven- tions, comparators, outcomes, timing, and setting; PRIME–MD = The Primary Care Evaluation of Mental Disorders; RCT = randomized controlled trial; SADS = The Schedule for Affective Disorders and Schizophrenia; SCAN = Schedules for Clinical Assessment in Neuropsychiatry; SCID = Structured Clinical Interview for DSM disorders.

References CDC Performance Review Boards or FOR FURTHER INFORMATION CONTACT: Liz 1. Roseman M, Kloda LA, Saadat N, et al. Panels, which will oversee the Hosna ([email protected]), Accuracy of Depression Screening Tools evaluation of performance appraisals of (410) 786–4993. to Detect Major Depression in Children Senior Executive Service members for SUPPLEMENTARY INFORMATION: and Adolescents: A Systematic Review. the Fiscal Year 2018 review period: I. Background Can J Psychiatry. 2016 Dec;61(12):746– Dean, Hazel Co-Chair 57. doi: 10.1177/0706743716651833. Shelton, Dana Co-Chair Section 1869(b)(1)(E) of the Social PMID: 27310247. Arispe, Irma Security Act (the Act), as amended by 2. Stockings E, Degenhardt L, Lee YY, et al. Boyle, Coleen section 521 of the Medicare, Medicaid, Symptom screening scales for detecting Branche, Christine and SCHIP Benefits Improvement and major depressive disorder in children Curlee, Robert C. Protection Act of 2000 (BIPA), and adolescents: a systematic review and meta-analysis of reliability, validity and Kosmos, Christine established the amount in controversy diagnostic utility. J Affect Disord. 2015 Peeples, Amy (AIC) threshold amounts for Mar 15;174:447–63. doi: 10.1016/ Qualters, Judith Administrative Law Judge (ALJ) j.jad.2014.11.061. PMID: 25553406. Ruiz, Roberto hearings and judicial review at $100 and Smagh, Kalwant $1,000, respectively, for Medicare Part Francis D. Chesley, Jr., Dated: September 17, 2018. A and Part B appeals. Section 940 of the Deputy Director. Sandra Cashman, Medicare Prescription Drug, [FR Doc. 2018–20481 Filed 9–19–18; 8:45 am] Executive Secretary, Centers for Disease Improvement, and Modernization Act of BILLING CODE 4160–90–P Control and Prevention. 2003 (MMA), amended section [FR Doc. 2018–20445 Filed 9–19–18; 8:45 am] 1869(b)(1)(E) of the Act to require the BILLING CODE 4163–18–P AIC threshold amounts for ALJ hearings DEPARTMENT OF HEALTH AND and judicial review to be adjusted HUMAN SERVICES annually. Beginning in January 2005, Centers for Disease Control and DEPARTMENT OF HEALTH AND the AIC threshold amounts are to be Prevention HUMAN SERVICES adjusted by the percentage increase in the medical care component of the Performance Review Board Members Centers for Medicare & Medicaid consumer price index (CPI) for all urban Services consumers (U.S. city average) for July AGENCY: Centers for Disease Control and 2003 to July of the year preceding the [CMS–4184–N] Prevention (CDC), Department of Health year involved and rounded to the and Human Services (HHS). Medicare Program; Medicare Appeals; nearest multiple of $10. Section ACTION: Notice. Adjustment to the Amount in 940(b)(2) of the MMA provided conforming amendments to apply the SUMMARY: The Centers for Disease Controversy Threshold Amounts for Calendar Year 2019 AIC adjustment requirement to Control and Prevention (CDC) located Medicare Part C/Medicare Advantage within the Department of Health and AGENCY: Centers for Medicare & (MA) appeals and certain health Human Services (HHS) is publishing the Medicaid Services (CMS), HHS. maintenance organization and names of the Performance Review Board ACTION: Notice. competitive health plan appeals. Health Members who are reviewing care prepayment plans are also subject performance for Fiscal Year 2018. SUMMARY: This notice announces the to MA appeals rules, including the AIC FOR FURTHER INFORMATION CONTACT: annual adjustment in the amount in adjustment requirement. Section 101 of Sandra DeShields, Chief, Compensation controversy (AIC) threshold amounts for the MMA provides for the application of and Performance Management Team, Administrative Law Judge (ALJ) the AIC adjustment requirement to Executive and Scientific Resources hearings and judicial review under the Medicare Part D appeals. Office, Human Resources Office, Centers Medicare appeals process. The for Disease Control and Prevention, 11 adjustment to the AIC threshold A. Medicare Part A and Part B Appeals Corporate Square Blvd., Mailstop US11– amounts will be effective for requests The statutory formula for the annual 2, Atlanta, Georgia 30341, Telephone for ALJ hearings and judicial review adjustment to the AIC threshold (770) 488–0252. filed on or after January 1, 2019. The amounts for ALJ hearings and judicial SUPPLEMENTARY INFORMATION: Title 5, calendar year 2019 AIC threshold review of Medicare Part A and Part B U.S.C. Section 4314(c)(4) of the Civil amounts are $160 for ALJ hearings and appeals, set forth at section Service Reform Act of 1978, Public Law $1,630 for judicial review. 1869(b)(1)(E) of the Act, is included in 95–454, requires that the appointment DATES: This annual adjustment is the applicable implementing of Performance Review Board Members effective for requests for ALJ hearings regulations, 42 CFR 405.1006(b) and (c). be published in the Federal Register. and judicial review filed on or after The regulations require the Secretary of The following persons will serve on the January 1, 2019. Health and Human Services (the

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Secretary) to publish changes to the AIC accordance with 42 CFR 417.600(b). The II. Provisions of the Notice—Annual threshold amounts in the Federal Medicare Part C appeals rules also apply AIC Adjustments Register (§ 405.1006(b)(2)). In order to to health care prepayment plan appeals be entitled to a hearing before an ALJ, in accordance with 42 CFR 417.840. A. AIC Adjustment Formula and AIC a party to a proceeding must meet the Adjustments D. Medicare Part D (Prescription Drug AIC requirements at § 405.1006(b). As previously noted, section 940 of Similarly, a party must meet the AIC Plan) Appeals the MMA requires that the AIC requirements at § 405.1006(c) at the time The annually adjusted AIC threshold threshold amounts be adjusted judicial review is requested for the court amounts for ALJ hearings and judicial annually, beginning in January 2005, by to have jurisdiction over the appeal review that apply to Medicare Parts A, (§ 405.1136(a)). the percentage increase in the medical B, and C appeals also apply to Medicare care component of the CPI for all urban B. Medicare Part C/MA Appeals Part D appeals. Section 101 of the MMA consumers (U.S. city average) from July added section 1860D–4(h)(1) of the Act Section 940(b)(2) of the MMA applies 2003 to July of the year preceding the regarding Part D appeals. This statutory the AIC adjustment requirement to year involved and rounded to the provision requires a prescription drug Medicare Part C appeals by amending nearest multiple of $10. section 1852(g)(5) of the Act. The plan sponsor to meet the requirements implementing regulations for Medicare set forth in sections 1852(g)(4) and (g)(5) B. Calendar Year 2019 Part C appeals are found at 42 CFR 422, of the Act, in a similar manner as MA organizations. As noted previously, the The AIC threshold amount for ALJ subpart M. Specifically, §§ 422.600 and hearings will remain at $160 and the 422.612 discuss the AIC threshold annually adjusted AIC threshold AIC threshold amount for judicial amounts for ALJ hearings and judicial requirement was added to section review will rise to $1,630 for CY 2019. review. Section 422.600 grants any party 1852(g)(5) of the Act by section to the reconsideration (except the MA 940(b)(2)(A) of the MMA. The These amounts are based on the 63.035 organization) who is dissatisfied with implementing regulations for Medicare percent increase in the medical care the reconsideration determination a Part D appeals can be found at 42 CFR component of the CPI, which was at right to an ALJ hearing as long as the 423, subparts M and U. The regulations 297.600 in July 2003 and rose to 485.193 amount remaining in controversy after at § 423.562(c) prescribe that, unless the in July 2018. The AIC threshold amount reconsideration meets the threshold Part D appeals rules provide otherwise, for ALJ hearings changes to $163.04 requirement established annually by the the Part C appeals rules (including the based on the 63.035 percent increase Secretary. Section 422.612 states, in annually adjusted AIC threshold over the initial threshold amount of part, that any party, including the MA amount) apply to Part D appeals to the $100 established in 2003. In accordance organization, may request judicial extent they are appropriate. More with section 1869(b)(1)(E)(iii) of the Act, review if the AIC meets the threshold specifically, §§ 423.1970 and 423.1976 the adjusted threshold amounts are requirement established annually by the of the Part D appeals rules discuss the rounded to the nearest multiple of $10. Secretary. AIC threshold amounts for ALJ hearings Therefore, the CY 2019 AIC threshold and judicial review. Section 423.1970(a) C. Health Maintenance Organizations, amount for ALJ hearings is $160.00. The grants a Part D enrollee, who is AIC threshold amount for judicial Competitive Medical Plans, and Health dissatisfied with the independent review changes to $1,630.35 based on Care Prepayment Plans review entity (IRE) reconsideration the 63.035 percent increase over the Section 1876(c)(5)(B) of the Act states determination, a right to an ALJ hearing initial threshold amount of $1,000. This that the annual adjustment to the AIC if the amount remaining in controversy amount was rounded to the nearest dollar amounts set forth in section after the IRE reconsideration meets the 1869(b)(1)(E)(iii) of the Act applies to threshold amount established annually multiple of $10, resulting in the CY certain beneficiary appeals within the by the Secretary. Sections 423.1976(a) 2019 AIC threshold amount of $1,630.00 context of health maintenance and (b) allow a Part D enrollee to for judicial review. organizations and competitive medical request judicial review of an ALJ or C. Summary Table of Adjustments in plans. The applicable implementing Medicare Appeals Council decision if, the AIC Threshold Amounts regulations for Medicare Part C appeals in part, the AIC meets the threshold are set forth in 42 CFR 422, subpart M amount established annually by the In the following table we list the CYs and apply to these appeals in Secretary. 2015 through 2019 threshold amounts.

CY 2015 CY 2016 CY 2017 CY 2018 CY 2019

ALJ Hearing ...... $150 $150 $160 $160 $160 Judicial Review...... 1,460 1,500 1,560 1,600 1,630

III. Collection of Information Paperwork Reduction Act of 1995 (44 DEPARTMENT OF HEALTH AND Requirements U.S.C. 3501 et seq.). HUMAN SERVICES Dated: August 31, 2018. This document does not impose Centers for Medicare & Medicaid information collection requirements, Seema Verma, Services that is, reporting, recordkeeping or Administrator, Centers for Medicare & third-party disclosure requirements. Medicaid Services. Privacy Act of 1974; Matching Program Consequently, there is no need for [FR Doc. 2018–20506 Filed 9–19–18; 8:45 am] review by the Office of Management and BILLING CODE 4120–01–P AGENCY: Centers for Medicare & Budget under the authority of the Medicaid Services (CMS), Department of Health and Human Services (HHS).

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ACTION: Notice of New Matching SUPPLEMENTARY INFORMATION: The immigrant, nonimmigrant, and Program. Privacy Act of 1974, as amended (5 naturalized or derived citizenship status U.S.C. 552a) provides certain information from USCIS’s SAVE SUMMARY: In accordance with subsection protections for individuals applying for program and VIS system. This data will (e)(12) of the Privacy Act of 1974, as and receiving federal benefits. The law indicate whether an applicant or amended, the Department of Health and governs the use of computer matching enrollee is lawfully present, a qualified Human Services (HHS), Centers for by federal agencies when records in a non-citizen, a naturalized or derived Medicare & Medicaid Services (CMS) is system of records (meaning, federal citizen, and whether the five-year providing notice of a new computer agency records about individuals waiting period for many non-citizens matching program between CMS and retrieved by name or other personal applies and has been met. CMS and the Department of Homeland Security identifier) are matched with records of state administering entities will use the (DHS)/United States Citizenship and other federal or non-federal agencies. data to determine the individual’s Immigration Services (USCIS), The Privacy Act requires agencies eligibility for enrollment in a qualified ‘‘Verification of United States involved in a matching program to: health plan through a federally- Citizenship and Immigration Status Data 1. Enter into a written agreement, facilitated exchange (FFE) and for for Eligibility Determinations.’’ In this which must be prepared in accordance insurance affordability programs and matching program, DHS/USCIS with the Privacy Act, approved by the certificates of exemption, and to make provides CMS with immigrant, Data Integrity Board of each source and eligibility redetermination and renewal nonimmigrant, and naturalized or recipient federal agency, provided to decisions, including appeal derived citizenship status information Congress and the Office of Management determinations. USCIS will provide the needed to make enrollment and and Budget (OMB), and made available data from USCIS’s SAVE program and exemption eligibility determinations as to the public, as required by 5 U.S.C. VIS system about individuals whose required by the Patient Protection and 552a(o), (u)(3)(A), and (u)(4). identifying information matches Affordable Care Act (ACA). 2. Notify the individuals whose identifying information that CMS information will be used in the DATES: The deadline for comments on submits to USCIS. CMS will make the this notice is October 22, 2018. The re- matching program that the information USCIS data available to requesting state established matching program will they provide is subject to verification administering entities through a data commence not sooner than 30 days after through matching, as required by 5 services hub (Hub). publication of this notice, provided no U.S.C. 552a(o)(1)(D). 3. Verify match findings before CATEGORIES OF INDIVIDUALS: comments are received that warrant a suspending, terminating, reducing, or The individuals whose information change to this notice. The matching making a final denial of an individual’s will be used in the matching program program will be conducted for an initial benefits or payments or taking other are consumers who apply for any of the term of 18 months (from approximately adverse action against the individual, as following eligibility determinations: October 2018 to April 2020) and within required by 5 U.S.C. 552a(p). eligibility to enroll in a qualified health 3 months of expiration may be renewed 4. Report the matching program to plan through an exchange established for one additional year if the parties Congress and the OMB, in advance and under the ACA, eligibility for insurance make no change to the matching annually, as required by 5 U.S.C. affordability programs and certificates of program and certify that the program 552a(o) (2)(A)(i), (r), and (u)(3)(D). exemption, and subsequent eligibility has been conducted in compliance with 5. Publish advance notice of the redeterminations and renewals, the matching agreement. matching program in the Federal including appeal determinations ADDRESSES: Interested parties may Register as required by 5 U.S.C. CATEGORIES OF RECORDS: submit comments on the new matching 552a(e)(12). The categories of records used in the program to the CMS Privacy Officer by This matching program meets these matching program are identity and mail at: Division of Security, Privacy requirements. citizenship status records. The data Policy & Governance, Information Barbara Demopulos, elements are described below. Security & Privacy Group, Office of • From the CMS to USCIS. CMS will Information Technology, Centers for CMS Privacy Advisor, Division of Security, submit data elements pertaining to Medicare & Medicaid Services, Privacy Policy and Governance, Information Security and Privacy Group, Office of applicants and enrollees through SAVE Location: N1–14–56, 7500 Security Information Technology, Centers for Medicare to the USCIS VIS. These data elements Blvd., Baltimore, MD 21244–1850, or & Medicaid Services. may include the following: [email protected]. Comments identification number (e.g., foreign received will be available for review PARTICIPATING AGENCIES: passport number, I–94 number, alien without redaction unless otherwise The Department of Health and Human registration number/USCIS number); advised by the commenter at this Services (HHS), Centers for Medicare & immigration document type; last name; location, by appointment, during regular Medicaid Services (CMS) is the middle initial; first name; date of birth; business hours, Monday through Friday recipient agency, and the Department of document expiration date (if from 9:00 a.m. to 3:00 p.m. Homeland Security (DHS), United States applicable); and information contained Citizenship and Immigration Services FOR FURTHER INFORMATION CONTACT: If in the comment field, such as USCIS (USCIS) is the source agency. you have questions about the matching benefit application receipt numbers, program, you may contact Jack Lavelle, AUTHORITY FOR CONDUCTING THE MATCHING maiden names, nicknames, and Senior Advisor, Marketplace Eligibility PROGRAM: additional immigration document and Enrollment Group, Centers for The statutory authority for the numbers. • Consumer Information and Insurance matching program is 42 U.S.C. 18001. From USCIS to CMS. USCIS Oversight, CMS, at (410) 786–0639, by through SAVE will send the Hub email at [email protected], or PURPOSE(S): responses that contain data from records by mail at 7501 Wisconsin Ave., The matching program will provide provided to VIS and databases VIS Bethesda, MD 20814. CMS with USCIS data, including accesses. These responses may include

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the following data elements: alien Electronic Submissions with a heading or cover note that states registration number/USCIS number; I– Submit electronic comments in the ‘‘THIS DOCUMENT CONTAINS 94 number; last name; first name; date following way: CONFIDENTIAL INFORMATION.’’ The of birth; date of entry; status grant date, • Federal eRulemaking Portal: Agency will review this copy, including if available; and immigration status https://www.regulations.gov. Follow the the claimed confidential information, in data. instructions for submitting comments. its consideration of comments. The Comments submitted electronically, second copy, which will have the SYSTEM OF RECORDS: claimed confidential information The records used in this matching including attachments, to https:// www.regulations.gov will be posted to redacted/blacked out, will be available program are disclosed from the for public viewing and posted on following systems of records, as the docket unchanged. Because your comment will be made public, you are https://www.regulations.gov. Submit authorized by routine uses published in both copies to the Dockets Management the System of Records Notices (SORNs) solely responsible for ensuring that your comment does not include any Staff. If you do not wish your name and cited below: contact information to be made publicly A. CMS System of Records: confidential information that you or a third party may not wish to be posted, available, you can provide this • CMS Health Insurance Exchanges information on the cover sheet and not System (HIX), CMS System No. 09–70– such as medical information, your or anyone else’s Social Security number, or in the body of your comments and you 0560, last published in full at 78 FR must identify this information as 63211 (Oct. 23, 2013), as amended at 83 confidential business information, such as a manufacturing process. Please note ‘‘confidential.’’ Any information marked FR 6591 (Feb. 14, 2018). Routine use 3 as ‘‘confidential’’ will not be disclosed supports CMS’s disclosures to USCIS. that if you include your name, contact information, or other information that except in accordance with 21 CFR 10.20 B. USCIS System of Records: and other applicable disclosure law. For • DHS/USCIS–004 Systematic Alien identifies you in the body of your comments, that information will be more information about FDA’s posting Verification for Entitlements Program, of comments to public dockets, see 80 81 FR 78619 (Nov. 8, 2016). Routine use posted on https://www.regulations.gov. • If you want to submit a comment FR 56469, September 18, 2015, or access H permits USCIS’ disclosures to CMS. with confidential information that you the information at: https://www.gpo.gov/ [FR Doc. 2018–20510 Filed 9–19–18; 8:45 am] do not wish to be made available to the fdsys/pkg/FR-2015-09-18/pdf/2015- BILLING CODE 4120–03–P public, submit the comment as a 23389.pdf. written/paper submission and in the Docket: For access to the docket to manner detailed (see ‘‘Written/Paper read background documents or the DEPARTMENT OF HEALTH AND Submissions’’ and ‘‘Instructions’’). electronic and written/paper comments HUMAN SERVICES received, go to https:// Written/Paper Submissions www.regulations.gov and insert the Food and Drug Administration Submit written/paper submissions as docket number, found in brackets in the heading of this document, into the [Docket No. FDA–2017–D–6526] follows: • Mail/Hand delivery/Courier (for ‘‘Search’’ box and follow the prompts Grandfathering Policy for Packages written/paper submissions): Dockets and/or go to the Dockets Management and Homogenous Cases of Product Management Staff (HFA–305), Food and Staff, 5630 Fishers Lane, Rm. 1061, Without a Product Identifier; Guidance Drug Administration, 5630 Fishers Rockville, MD 20852. for Industry; Availability Lane, Rm. 1061, Rockville, MD 20852. You may submit comments on any • For written/paper comments guidance at any time (see 21 CFR AGENCY: Food and Drug Administration, submitted to the Dockets Management 10.115(g)(5)). HHS. Staff, FDA will post your comment, as Submit written requests for single ACTION: Notice of availability. well as any attachments, except for copies of this guidance to the Division information submitted, marked and of Drug Information, Center for Drug SUMMARY: The Food and Drug identified, as confidential, if submitted Evaluation and Research, Food and Administration (FDA or Agency) is as detailed in ‘‘Instructions.’’ Drug Administration, 10001 New announcing the availability of a final Instructions: All submissions received Hampshire Ave., Hillandale Building, guidance for industry entitled must include the Docket No. FDA– 4th Floor, Silver Spring, MD 20993– ‘‘Grandfathering Policy for Packages and 2017–D–6526 for ‘‘Grandfathering 0002, or the Office of Communication, Homogenous Cases of Product Without Policy for Packages and Homogenous Outreach, and Development, Center for a Product Identifier.’’ This guidance Cases of Product Without a Product Biologics Evaluation and Research, specifies whether and under what Identifier.’’ Received comments will be Food and Drug Administration, 10903 circumstances packages and placed in the docket and, except for New Hampshire Ave., Bldg. 71, Rm. homogenous cases of product not those submitted as ‘‘Confidential 3128, Silver Spring, MD 20993–0002. labeled with a product identifier shall Submissions,’’ publicly viewable at Send one self-addressed adhesive label be grandfathered from certain https://www.regulations.gov or at the to assist that office in processing your requirements of the Federal Food, Drug, Dockets Management Staff between 9 requests. See the SUPPLEMENTARY and Cosmetic Act (FD&C Act). This a.m. and 4 p.m., Monday through INFORMATION section for electronic guidance finalizes the draft guidance Friday. access to the guidance document. issued on November 27, 2017. • Confidential Submissions—To FOR FURTHER INFORMATION CONTACT: DATES: The announcement of the submit a comment with confidential Abha Kundi, Office of Compliance, guidance is published in the Federal information that you do not wish to be Center for Drug Evaluation and Register on September 20, 2018. made publicly available, submit your Research, Food and Drug ADDRESSES: You may submit either comments only as a written/paper Administration, 10903 New Hampshire electronic or written comments on submission. You should submit two Ave., Silver Spring, MD 20993–0002, Agency guidances at any time as copies total. One copy will include the 301–796–3130, drugtrackandtrace@ follows: information you claim to be confidential fda.hhs.gov.

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SUPPLEMENTARY INFORMATION: November 27, 2019, and November 27, Dated: September 14, 2018. 2020, respectively. Leslie Kux, I. Background In section 582(a)(5)(A) of the FD&C Associate Commissioner for Policy. FDA is announcing the availability of Act, Congress directed FDA to issue [FR Doc. 2018–20503 Filed 9–19–18; 8:45 am] a guidance for industry entitled guidance specifying ‘‘whether and BILLING CODE 4164–01–P ‘‘Grandfathering Policy for Packages and under what circumstances product that Homogenous Cases of Product Without is not labeled with a product identifier a Product Identifier.’’ On November 27, and that is in the pharmaceutical supply DEPARTMENT OF HEALTH AND 2013, the Drug Supply Chain Security chain at the time at the time of the HUMAN SERVICES Act (DSCSA) (Title II of Pub. L. 113–54) effective date of the requirements of was signed into law. Section 202 of the [section 582] shall be exempted’’ from Food and Drug Administration DSCSA added section 582 to the FD&C the product tracing requirements [Docket No. FDA–2015–D–2167] Act (21 U.S.C. 360eee–1), which discussed previously. The guidance established product tracing addresses this requirement. As Heparin-Containing Medical Devices requirements for manufacturers, explained in the guidance, only and Combination Products: repackagers, wholesale distributors, and packages and homogenous cases of Recommendations for Labeling and dispensers. The DSCSA phases in its product that are in the pharmaceutical Safety Testing; Guidance for Industry requirements over a 10-year period. distribution supply chain at the time of and Food and Drug Administration A critical set of phased product the effective date of the requirements of Staff; Availability tracing requirements outlined in section section 582 are eligible for 582 of the FD&C Act relates to the grandfathering under section AGENCY: Food and Drug Administration, product identifier. Among its 582(a)(5)(A) of the FD&C Act. HHS. provisions, section 582 of the FD&C Act In the Federal Register of November ACTION: Notice of availability. requires that each package and 27, 2017 (82 FR 56033), FDA issued a homogenous case of product in the notice announcing the availability of the SUMMARY: The Food and Drug pharmaceutical distribution supply draft version of this guidance. The Administration (FDA or Agency) is chain bear a product identifier that is comment period for the draft guidance announcing the availability of a final encoded with the product’s ended January 26, 2018. FDA received guidance entitled ‘‘Heparin-Containing standardized numerical identifier, lot approximately 10 comments on the draft Medical Devices and Combination number, and expiration date by specific guidance. In response to received Products: Recommendations for dates. Under the statute, manufacturers comments or on its own initiative, FDA Labeling and Safety Testing.’’ The were required to begin affixing or made several changes. The most United States Pharmacopeia (USP) drug imprinting a product identifier to each significant change FDA made was to substance monograph for Heparin package and homogenous case of a revise the grandfathering exemption to Sodium, and drug product monographs product intended to be introduced into include products repackaged by a for Heparin Lock Flush Solution and commerce no later than November 27, repackager before November 27, 2018. Heparin Sodium Injection, recently have 2017. Repackagers are required to do the FDA made this change in response to undergone several revisions following same no later than November 27, 2018. comments indicating that repackagers serious and fatal events related to the Sections 582(c)(2), (d)(2), and will need time beyond November 27, use of heparin sodium products. (e)(2)(A)(iii) of the FD&C Act restrict 2018, to sell such product. In addition, Investigation of heparin product trading partners’ ability to engage in FDA made editorial and formatting overdose errors identified the transactions involving packages and changes to improve clarity. expression of drug strength in the labels homogenous cases of product that are This guidance is being issued as a major contributing factor in these not labeled with a product identifier consistent with FDA’s good guidance errors. This guidance document after specific dates. Beginning practices regulation (21 CFR 10.115). addresses these safety concerns by November 27, 2018, repackagers may The guidance represents the current clarifying new expectations for labeling not engage in a transaction involving a thinking of FDA on ‘‘Grandfathering with regard to the revised heparin USP package or homogenous case of a Policy for Packages and Homogenous monographs, as well as outlining safety product that is not encoded with a Cases of Product Without a Product testing recommendations. product identifier. Similar restrictions Identifier.’’ It does not establish any DATES: The announcement of the go into effect for wholesale distributors rights for any person and, with the guidance is published in the Federal and dispensers on November 27, 2019, exception of specified material in Register on September 20, 2018. and November 27, 2020, respectively. section IV, is not binding on FDA or the ADDRESSES: You may submit either In addition, section 582 of the FD&C public. You can use an alternative electronic or written comments on Act requires trading partners to verify approach if it satisfies the requirements Agency guidances at any time as product identifiers on packages and of the applicable statutes and follows: homogenous cases starting on November regulations. This guidance is not subject 27, 2017, for manufacturers (section to Executive Order 12866. Electronic Submissions 582(b)(4)); on November 27, 2019, for Submit electronic comments in the wholesale distributors (section II. Electronic Access following way: 582(c)(4)); on November 27, 2020, for Persons with access to the internet • Federal eRulemaking Portal: dispensers (section 582(d)(4)); and on may obtain the guidance at https:// https://www.regulations.gov. Follow the November 27, 2018, for repackagers www.fda.gov/Drugs/Guidance instructions for submitting comments. (section 582(e)(4)). Manufacturers, ComplianceRegulatoryInformation/ Comments submitted electronically, repackagers, wholesale distributors, and Guidances/default.htm, https:// including attachments, to https:// dispensers are also required to verify the www.fda.gov/BiologicsBloodVaccines/ www.regulations.gov will be posted to product identifier of a saleable returned GuidanceComplianceRegulatory the docket unchanged. Because your package or sealed homogenous case on Information/Guidances/default.htm, or comment will be made public, you are November 27, 2017, November 27, 2018, https://www.regulations.gov. solely responsible for ensuring that your

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comment does not include any contact information to be made publicly products. Investigation of heparin confidential information that you or a available, you can provide this product overdose errors identified the third party may not wish to be posted, information on the cover sheet and not expression of drug strength in the labels such as medical information, your or in the body of your comments and you as a major contributing factor in these anyone else’s Social Security number, or must identify this information as errors. This guidance document confidential business information, such ‘‘confidential.’’ Any information marked addresses these safety concerns by as a manufacturing process. Please note as ‘‘confidential’’ will not be disclosed clarifying new expectations for labeling that if you include your name, contact except in accordance with 21 CFR 10.20 with regard to the revised heparin USP information, or other information that and other applicable disclosure law. For monographs, as well as outlining safety identifies you in the body of your more information about FDA’s posting testing recommendations. comments, that information will be of comments to public dockets, see 80 In addition, the outbreak of serious posted on https://www.regulations.gov. FR 56469, September 18, 2015, or access and often fatal events due to heparin • If you want to submit a comment the information at: https://www.gpo.gov/ contamination with over-sulfated with confidential information that you fdsys/pkg/FR-2015-09-18/pdf/2015- chondroitin sulfate in 2008 led the USP do not wish to be made available to the 23389.pdf. to include in its monograph additional public, submit the comment as a Docket: For access to the docket to testing of heparin source material to written/paper submission and in the read background documents or the ensure its quality and purity. This manner detailed (see ‘‘Written/Paper electronic and written/paper comments guidance also outlines use of Submissions’’ and ‘‘Instructions’’). received, go to https:// conformance to the monograph in premarket submissions, specifically Written/Paper Submissions www.regulations.gov and insert the docket number, found in brackets in the testing and documentation requirements Submit written/paper submissions as heading of this document, into the and/or recommendations contained in follows: ‘‘Search’’ box and follow the prompts the current USP monographs and the • Mail/Hand delivery/Courier (for and/or go to the Dockets Management guidance document ‘‘Heparin for Drug written/paper submissions): Dockets Staff, 5630 Fishers Lane, Rm. 1061, and Medical Device Use: Monitoring Management Staff (HFA–305), Food and Rockville, MD 20852. Crude Heparin for Quality’’ (https:// Drug Administration, 5630 Fishers You may submit comments on any www.fda.gov/downloads/Drugs/ Lane, Rm. 1061, Rockville, MD 20852. guidance at any time (see 21 CFR GuidanceComplianceRegulatory • For written/paper comments 10.115(g)(5)). Information/Guidances/ submitted to the Dockets Management 2 An electronic copy of the guidance UCM291390.pdf). Staff, FDA will post your comment, as document is available for download FDA considered comments received well as any attachments, except for from the internet. See the on the draft guidance that appeared in information submitted, marked and SUPPLEMENTARY INFORMATION section for the Federal Register of July 9, 2015 (80 identified, as confidential, if submitted information on electronic access to the FR 39440). FDA revised the guidance as as detailed in ‘‘Instructions.’’ guidance. Submit written requests for a appropriate in response to the Instructions: All submissions received comments. must include the Docket No. FDA– single hard copy of the guidance 2015–D–2167 for ‘‘Heparin-Containing document entitled ‘‘Heparin-Containing II. Significance of Guidance Medical Devices and Combination Medical Devices and Combination This guidance is being issued Products: Recommendations for Products: Recommendations for consistent with FDA’s good guidance Labeling and Safety Testing.’’ Received Labeling and Safety Testing’’ to the practices regulation (21 CFR 10.115). comments will be placed in the docket Office of the Center Director, Guidance The guidance represents the current and, except for those submitted as and Policy Development, Center for thinking of FDA on ‘‘Heparin- ‘‘Confidential Submissions,’’ publicly Devices and Radiological Health, Food Containing Medical Devices and viewable at https://www.regulations.gov and Drug Administration, 10903 New Combination Products: or at the Dockets Management Staff Hampshire Ave., Bldg. 66, Rm. 5431, Recommendations for Labeling and between 9 a.m. and 4 p.m., Monday Silver Spring, MD 20993–0002. Send Safety Testing.’’ It does not establish through Friday. one self-addressed adhesive label to any rights for any person and is not • Confidential Submissions—To assist that office in processing your binding on FDA or the public. You can submit a comment with confidential request. use an alternative approach if it satisfies information that you do not wish to be FOR FURTHER INFORMATION CONTACT: the requirements of the applicable made publicly available, submit your Andrew Yeatts, Center for Devices and statutes and regulations. This guidance comments only as a written/paper Radiological Health, Food and Drug is not subject to Executive Order 12866. submission. You should submit two Administration, 10903 New Hampshire III. Electronic Access copies total. One copy will include the Ave., Bldg. 66, Rm. 1643, Silver Spring, information you claim to be confidential MD 20993–0002, 301–796–4539. Persons interested in obtaining a copy with a heading or cover note that states SUPPLEMENTARY INFORMATION: of the guidance may do so by ‘‘THIS DOCUMENT CONTAINS downloading an electronic copy from CONFIDENTIAL INFORMATION.’’ The I. Background the internet. A search capability for all Agency will review this copy, including The USP 1 heparin monographs have Center for Devices and Radiological the claimed confidential information, in recently undergone several revisions Health guidance documents is available its consideration of comments. The following serious and fatal events at https://www.fda.gov/MedicalDevices/ second copy, which will have the related to the use of heparin sodium DeviceRegulationandGuidance/ claimed confidential information GuidanceDocuments/default.htm. This redacted/blacked out, will be available 1 USP is a scientific nonprofit organization that for public viewing and posted on develops standards for the identity, strength, 2 The Agency updates guidances periodically. To quality, and purity of drugs and drug ingredients make sure you have the most recent version of this https://www.regulations.gov. Submit marketed in the United States. These standards are guidance, check the FDA guidance page at https:// both copies to the Dockets Management published in USP’s official compendia, U.S. www.fda.gov/RegulatoryInformation/Guidances/ Staff. If you do not wish your name and Pharmacopeia and National Formulary. default.htm.

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guidance is also available at https:// to receive an electronic copy of the subject to review by the Office of www.regulations.gov. Persons unable to document. Please use the document Management and Budget (OMB) under download an electronic copy of number 1817 to identify the guidance the Paperwork Reduction Act of 1995 ‘‘Heparin-Containing Medical Devices you are requesting. (44 U.S.C. 3501–3520). The collections and Combination Products: IV. Paperwork Reduction Act of 1995 of information in the following FDA Recommendations for Labeling and regulations and guidance have been This guidance refers to previously Safety Testing’’ may send an email approved by OMB as listed in the approved collections of information. request to [email protected] following table: These collections of information are

OMB 21 CFR part; guidance; or FDA form Topic control No.

211 ...... Current good manufacturing practice for finished pharmaceuticals ...... 0910–0139 807, subpart E ...... Premarket notification ...... 0910–0120 814, subparts A through E ...... Premarket approval ...... 0910–0231 814, subpart H ...... Humanitarian Device Exemption ...... 0910–0332 812 ...... Investigational Device Exemption ...... 0910–0078 ‘‘De Novo Classification Process (Evaluation of De Novo classification process ...... 0910–0844 Automatic Class III Designation)’’. 801 ...... Medical Device Labeling Regulations ...... 0910–0485 803 ...... Medical Devices; Medical Device Reporting; Manufacturer reporting, importer 0910–0437 reporting, user facility reporting, distributor reporting. 820 ...... Quality System (QS) Regulation ...... 0910–0073

Dated: September 17, 2018. Electronic Submissions information submitted, marked and Leslie Kux, Submit electronic comments in the identified, as confidential, if submitted Associate Commissioner for Policy. following way: as detailed in ‘‘Instructions.’’ [FR Doc. 2018–20472 Filed 9–19–18; 8:45 am] • Federal eRulemaking Portal: Instructions: All submissions received must include the Docket No. FDA– BILLING CODE 4164–01–P https://www.regulations.gov. Follow the instructions for submitting comments. 2017–D–2232 for ‘‘Product Identifier Comments submitted electronically, Requirements Under the Drug Supply DEPARTMENT OF HEALTH AND including attachments, to https:// Chain Security Act—Compliance HUMAN SERVICES www.regulations.gov will be posted to Policy.’’ Received comments will be the docket unchanged. Because your placed in the docket and, except for Food and Drug Administration comment will be made public, you are those submitted as ‘‘Confidential Submissions,’’ publicly viewable at [Docket No. FDA–2017–D–2232] solely responsible for ensuring that your comment does not include any https://www.regulations.gov or at the Product Identifier Requirements Under confidential information that you or a Dockets Management Staff between 9 the Drug Supply Chain Security Act— third party may not wish to be posted, a.m. and 4 p.m., Monday through Friday. Compliance Policy; Guidance for such as medical information, your or • Industry; Availability anyone else’s Social Security number, or Confidential Submissions—To confidential business information, such submit a comment with confidential AGENCY: Food and Drug Administration, as a manufacturing process. Please note information that you do not wish to be HHS. that if you include your name, contact made publicly available, submit your ACTION: Notice of availability. information, or other information that comments only as a written/paper submission. You should submit two SUMMARY: The Food and Drug identifies you in the body of your comments, that information will be copies total. One copy will include the Administration (FDA or Agency) is information you claim to be confidential announcing the availability of a final posted on https://www.regulations.gov. • If you want to submit a comment with a heading or cover note that states guidance for industry entitled ‘‘Product ‘‘THIS DOCUMENT CONTAINS Identifier Requirements Under the Drug with confidential information that you do not wish to be made available to the CONFIDENTIAL INFORMATION.’’ The Supply Chain Security Act— Agency will review this copy, including Compliance Policy.’’ This guidance public, submit the comment as a written/paper submission and in the the claimed confidential information, in describes FDA’s intention with regard to its consideration of comments. The enforcement of the Drug Supply Chain manner detailed (see ‘‘Written/Paper Submissions’’ and ‘‘Instructions’’). second copy, which will have the Security Act (DSCSA) provision claimed confidential information requiring manufacturers to begin Written/Paper Submissions redacted/blacked out, will be available affixing or imprinting product Submit written/paper submissions as for public viewing and posted on identifiers on their products beginning follows: https://www.regulations.gov. Submit November 27, 2017. This guidance • Mail/Hand delivery/Courier (for both copies to the Dockets Management finalizes the draft guidance issued on written/paper submissions): Dockets Staff. If you do not wish your name and July 3, 2017. Management Staff (HFA–305), Food and contact information to be made publicly DATES: The announcement of the Drug Administration, 5630 Fishers available, you can provide this guidance is published in the Federal Lane, Rm. 1061, Rockville, MD 20852. information on the cover sheet and not Register on September 20, 2018. • For written/paper comments in the body of your comments and you ADDRESSES: You may submit either submitted to the Dockets Management must identify this information as electronic or written comments on Staff, FDA will post your comment, as ‘‘confidential.’’ Any information marked Agency Guidance at any time as follows: well as any attachments, except for as ‘‘confidential’’ will not be disclosed

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except in accordance with 21 CFR 10.20 section 582 of the FD&C Act requires product purchased from repackagers and other applicable disclosure law. For that each package and homogenous case after November 27, 2018, is affixed or more information about FDA’s posting of product in the pharmaceutical imprinted with a product identifier. of comments to public dockets, see 80 distribution supply chain bear a product Finally, FDA removed the FR 56469, September 18, 2015, or access identifier that is encoded with the recommendations in the draft version of the information at: https://www.gpo.gov/ product’s standardized numerical this guidance related to the fdsys/pkg/FR-2015-09-18/pdf/2015- identifier, lot number, and expiration documentation for determining when a 23389.pdf. date by specific dates. Under the statute, product without a product identifier Docket: For access to the docket to manufacturers were required to begin was introduced in a transaction into read background documents or the affixing or imprinting a product commerce by a manufacturer. The topic electronic and written/paper comments identifier to each package and of documentation is addressed in the received, go to https:// homogenous case of a product intended final grandfathering policy guidance. www.regulations.gov and insert the to be introduced into commerce no later This guidance is being issued docket number, found in brackets in the than November 27, 2017. Failure to consistent with FDA’s good guidance heading of this document, into the comply with this and other practices regulation (21 CFR 10.115). ‘‘Search’’ box and follow the prompts requirements of section 582 is The guidance represents the current and/or go to the Dockets Management prohibited under section 301(t) of the thinking of FDA on ‘‘Product Identifier Staff, 5630 Fishers Lane, Rm. 1061, FD&C Act (21 U.S.C. 331(t)) and subject Requirements Under the Drug Supply Rockville, MD 20852. You may submit to enforcement action under the FD&C Chain Security Act—Compliance comments on any guidance at any time Act. Policy.’’ It does not establish any rights (see 21 CFR 10.115(g)(5)). In the Federal Register of July 3, 2017 for any person and is not binding on Submit written requests for single (82 FR 30868), FDA issued a notice FDA or the public. You can use an copies of the draft guidance to the announcing the availability of the draft alternative approach if it satisfies the Division of Drug Information, Center for version of this guidance. As described requirements of the applicable statutes Drug Evaluation and Research, Food in the guidance, in the years since the and regulations. This guidance is not and Drug Administration, 10001 New passage of DSCSA, FDA had received subject to Executive Order 12866. comments and feedback from Hampshire Ave., Hillandale Building, II. Electronic Access 4th Floor, Silver Spring, MD 20993– manufacturers and other trading 0002, or the Office of Communication, partners expressing concern with Persons with access to the internet Outreach and Development, Center for industry-wide readiness for may obtain the guidance at https:// Biologics Evaluation and Research, implementation of the DSCSA provision www.fda.gov/Drugs/Guidance Food and Drug Administration, 10903 requiring manufacturers to begin putting ComplianceRegulatoryInformation/ New Hampshire Ave., Building 71, Rm. product identifiers on their products by Guidances/default.htm, https:// 3128, Silver Spring, MD 20993–0002. November 27, 2017. Given the www.fda.gov/BiologicsBloodVaccines/ Send one self-addressed adhesive label implementation challenges that industry GuidanceComplianceRegulatory to assist that office in processing your has encountered, FDA recognized that Information/Guidances/default.htm, or requests. See the SUPPLEMENTARY some manufacturers would need https://www.regulations.gov. INFORMATION section for electronic additional time beyond November 27, Dated: September 14, 2018. access to the draft guidance document. 2017, to ensure that their products bear Leslie Kux, a product identifier as required by the FOR FURTHER INFORMATION CONTACT: Associate Commissioner for Policy. DSCSA. To minimize possible Connie Jung, Office of Compliance, [FR Doc. 2018–20444 Filed 9–19–18; 8:45 am] disruptions in the distribution of Center for Drug Evaluation and BILLING CODE 4164–01–P prescription drugs in the United States, Research, Food and Drug FDA does not intend to take action Administration, 10903 New Hampshire against manufacturers who do not affix Ave., Silver Spring, MD 20993–0002, DEPARTMENT OF HEALTH AND or imprint a product identifier to HUMAN SERVICES 301–796–3130, drugtrackandtrace@ packages or homogenous cases of fda.hhs.gov. product that are packaged before Food and Drug Administration SUPPLEMENTARY INFORMATION: November 27, 2018. This includes [Docket No. FDA–2018–D–3175] I. Background packages and homogenous cases of product that are packaged by a Product Identifiers Under the Drug FDA is announcing the availability of manufacturer on or after November 27, Supply Chain Security Act Questions a guidance for industry entitled 2017. The comment period for the draft and Answers; Draft Guidance for ‘‘Product Identifier Requirements Under guidance ended September 1, 2017. Industry; Availability the Drug Supply Chain Security Act— FDA received 19 comments on the draft Compliance Policy.’’ On November 27, guidance. AGENCY: Food and Drug Administration, 2013, the DSCSA (Title II of Pub. L. FDA made several changes to the HHS. 113–54) was signed into law. Section guidance. We streamlined the guidance ACTION: Notice of availability. 202 of the DSCSA added section 582 to to remove information that is portions of the Federal Food, Drug, and Cosmetic the draft version of this guidance SUMMARY: The Food and Drug Act (FD&C Act) (21 U.S.C. 360eee–1) because they were repetitive of the Administration FDA or Agency) is which established product tracing, information in the final guidance for announcing the availability of a draft product identifier, authorized trading industry entitled, ‘‘Grandfathering guidance for industry entitled ‘‘Product partner and verification requirements Policy for Packages and Homogenous Identifiers Under the Drug Supply for manufacturers, repackagers, Cases of Product Without a Product Chain Security Act Questions and wholesale distributors, and dispensers Identifier.’’ In addition, FDA removed Answers.’’ This draft guidance intends to facilitate the tracing of products the language in the draft version of this to clarify questions relating to product through the pharmaceutical distribution guidance on wholesale distributor and identifiers that are required by the supply chain. Among its provisions, dispenser responsibilities to ensure Federal Food, Drug, and Cosmetic Act

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(FD&C Act), as amended by the Drug Staff, FDA will post your comment, as Division of Drug Information, Center for Supply Chain Security Act (DSCSA) for well as any attachments, except for Drug Evaluation and Research, Food packages and homogenous cases of information submitted, marked, and and Drug Administration, 10001 New certain drug products. Sections of the identified, as confidential, if submitted Hampshire Ave., Hillandale Building, FD&C Act require manufacturers and as detailed in ‘‘Instructions.’’ 4th Floor, Silver Spring, MD 20993– repackagers to affix or imprint a product Instructions: All submissions received 0002; or to the Office of identifier to each package and must include the Docket No. FDA– Communication, Outreach and homogenous case of a product intended 2018–D–3175 for ‘‘Product Identifiers Development, Center for Biologics to be introduced in a transaction into Under the Drug Supply Chain Security Evaluation and Research, Food and commerce beginning November 27, Act Questions and Answers.’’ Received Drug Administration, 10903 New 2017, and November 28, 2018, comments will be placed in the docket Hampshire Ave., Bldg. 71, Rm. 3128, respectively. This draft guidance and, except for those submitted as Silver Spring, MD 20993–0002. Send intends to clarify these requirements. ‘‘Confidential Submissions,’’ publicly one self-addressed adhesive label to DATES: Submit either electronic or viewable at https://www.regulations.gov assist that office in processing your written comments on the draft guidance or at the Dockets Management Staff requests. See the SUPPLEMENTARY by November 19, 2018 to ensure that the between 9 a.m. and 4 p.m., Monday INFORMATION section for electronic Agency considers your comment on this through Friday. access to the draft guidance document. • Confidential Submissions—To draft guidance before it begins work on FOR FURTHER INFORMATION CONTACT: Tia submit a comment with confidential the final version of the guidance. Harper-Velazquez, Office of information that you do not wish to be Submit either electronic or written Compliance, Center for Drug Evaluation made publicly available, submit your and Research, Food and Drug comments concerning the collection of comments only as a written/paper Administration, 10903 New Hampshire information proposed in the draft submission. You should submit two Ave., Silver Spring, MD 20993–0002, guidance by November 19, 2018. copies total. One copy will include the ADDRESSES: You may submit comments information you claim to be confidential 301–796–3130, as follows: with a heading or cover note that states [email protected]. SUPPLEMENTARY INFORMATION: Electronic Submissions ‘‘THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.’’ The I. Background Submit electronic comments in the Agency will review this copy, including following way: the claimed confidential information, in The DSCSA (Title II of Pub. L. 113– • Federal eRulemaking Portal: its consideration of comments. The 54) was signed into law on November https://www.regulations.gov. Follow the second copy, which will have the 27, 2013. Section 202 of the DSCSA instructions for submitting comments. claimed confidential information added section 582 to the FD&C Act (21 Comments submitted electronically, redacted/blacked out, will be available U.S.C. 360eee–1). This section including attachments, to https:// for public viewing and posted on establishes product tracing, product www.regulations.gov will be posted to https://www.regulations.gov. Submit identifier, and verification requirements the docket unchanged. Because your both copies to the Dockets Management for manufacturers, repackagers, comment will be made public, you are Staff. If you do not wish your name and wholesale distributors, and dispensers solely responsible for ensuring that your contact information to be made publicly to facilitate the tracing of products comment does not include any available, you can provide this through the pharmaceutical distribution confidential information that you or a information on the cover sheet and not supply chain. Failure to comply with third party may not wish to be posted, in the body of your comments and you the requirements of section 582 is a such as medical information, your or must identify this information as prohibited act under section 301(t) of anyone else’s Social Security number, or ‘‘confidential.’’ Any information marked the FD&C Act (21 U.S.C. 331(t)). confidential business information, such as ‘‘confidential’’ will not be disclosed The effective date for manufacturers as a manufacturing process. Please note except in accordance with 21 CFR 10.20 to ‘‘affix or imprint a product identifier that if you include your name, contact and other applicable disclosure law. For to each package and homogenous case information, or other information that more information about FDA’s posting of a product intended to be introduced identifies you in the body of your of comments to public dockets, see 80 in a transaction into commerce’’ under comments, that information will be FR 56469, September 18, 2015, or access section 582(b)(2)(A) of the FD&C Act, is posted on https://www.regulations.gov. the information at: https://www.gpo.gov/ not later than November 27, 2017. In • If you want to submit a comment fdsys/pkg/FR-2015-09-18/pdf/2015- June 2017, FDA published a draft with confidential information that you 23389.pdf. guidance entitled ‘‘Product Identifier do not wish to be made available to the Docket: For access to the docket to Requirements Under the Drug Supply public, submit the comment as a read background documents or the Chain Security Act—Compliance written/paper submission and in the electronic and written/paper comments Policy,’’ in which FDA describes its manner detailed (see ‘‘Written/Paper received, go to https:// intention regarding the enforcement of Submissions’’ and ‘‘Instructions’’). www.regulations.gov and insert the certain product identifiers under the DSCSA. As described in the draft Written/Paper Submissions docket number, found in brackets in the heading of this document, into the guidance, FDA does not intend to take Submit written/paper submissions as ‘‘Search’’ box and follow the prompts action against manufacturers who do follows: and/or go to the Dockets Management not affix or imprint a product identifier • Mail/Hand delivery/Courier (for Staff, 5630 Fishers Lane, Rm. 1061, to each package and homogenous case written/paper submissions): Dockets Rockville, MD 20852. of products intended to be introduced in Management Staff (HFA–305), Food and You may submit comments on any a transaction into commerce before Drug Administration, 5630 Fishers guidance at any time (see 21 CFR November 26, 2018. This represents a 1- Lane, Rm. 1061, Rockville, MD 20852. 10.115(g)(5)). year delay in enforcement of the • For written/paper comments Submit written requests for single requirement for manufacturers to affix submitted to the Dockets Management copies of the draft guidance to the or imprint product identifiers. The

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effective date for repackagers to ‘‘affix or Dated: September 14, 2018. grandfathered group health plans and imprint a product identifier to each Leslie Kux, health insurance issuers offering group package and homogenous case of a Associate Commissioner for Policy. or individual health insurance are product intended to be introduced in a [FR Doc. 2018–20502 Filed 9–19–18; 8:45 am] required to provide insurance coverage transaction in commerce’’ under section BILLING CODE 4164–01–P without cost-sharing (a co-payment, co- 582(e)(2)(A) of the FD&C Act, is not later insurance, or deductible) for preventive than November 27, 2018. services for plan years (i.e., policy years) beginning on or after the date that is one This guidance is intended to assist DEPARTMENT OF HEALTH AND HUMAN SERVICES year from the Secretary’s adoption of the manufacturers and repackagers in condition for screening. understanding the requirements to affix Health Resources and Services During the November meeting, the or imprint a product identifier on each Administration Meeting of the Advisory ACHDNC will hear from experts in the package and homogenous case of Committee on Heritable Disorders in field and discuss issues related to product that they introduce in a Newborns and Children newborn screening information, transaction into commerce to satisfy the education, training activities, and product identifier requirement of AGENCY: Health Resources and Services training resources. The ACHDNC will section 582 of the FD&C Act. The Administration (HRSA), Department of hear presentations on the use of recommendations in this guidance are Health and Human Services (HHS). genomic sequencing in newborn intended to assist manufacturers and ACTION: Notice. screening as well as the clinical setting repackagers in standardizing both the for both well and sick infants. The human-readable and machine-readable SUMMARY: The Advisory Committee on ACHDNC will also discuss the format of the information that is Heritable Disorders in Newborns and nomination of cerebrotendinous contained in the product identifier. This Children (ACHDNC) has scheduled a xanthomatosis (CTX) to the RUSP and guidance also intends to clarify that public meeting. Information about the vote on whether to move the these requirements do not change the ACHDNC, a roster of members, the nomination forward to evidence review. linear barcode requirements. meeting agenda, as well as past meeting Note that this vote is not on a proposed summaries is located on the ACHDNC This draft guidance is being issued addition of a condition to the RUSP. website at https://www.hrsa.gov/ Agenda items are subject to change as consistent with FDA’s good guidance advisory-committees/heritable- priorities dictate. Refer to the ACHDNC practices regulation (21 CFR 10.115). disorders/index.html. website for any updated information The draft guidance, when finalized, will DATES: November 1, 2018, 10:30 a.m.– concerning the meeting. Members of the represent the current thinking of FDA 5:30 p.m. ET and November 2, 2018, public will have the opportunity to on ‘‘Product Identifiers Under the 9:00 a.m.–3:00 p.m. ET. provide comments, which are part of the Supply Chain Security Act Questions ADDRESSES: This meeting will be held in official Committee record. To submit and Answers.’’ It does not establish any written comments or request time for an rights for any person and is not binding person and by webinar. Advanced registration is required. Please register oral comment at the meeting, please on FDA or the public. You can use an online at http:// register online by 12:00 p.m. ET on alternative approach if it satisfies the www.achdncmeetings.org/ by 12:00 p.m. October 26, 2018, at http:// requirements of the applicable statutes ET on October 29, 2018. The address for www.achdncmeetings.org. Oral and regulations. This guidance is not the meeting is 5600 Fishers Lane, comments will be honored in the order subject to Executive Order 12866. Rockville, Maryland 20857. they are requested and may be limited as time allows. Individuals associated II. Paperwork Reduction Act of 1995 FOR FURTHER INFORMATION CONTACT: Ann with groups or who plan to provide Ferrero, Maternal and Child Health comments on similar topics may be This draft guidance includes Bureau (MCHB), HRSA, 5600 Fishers asked to combine their comments and information collection provisions that Lane, Room 18N100C, Rockville, present them through a single are subject to review by the Office of Maryland 20857; 301–443–3999; or representative. No audiovisual Management and Budget (OMB) under [email protected]. the Paperwork Reduction Act (PRA) of presentations are permitted. Written SUPPLEMENTARY INFORMATION: The 1995 (44 U.S.C. 3501–3520) (PRA). In comments should identify the ACHDNC provides advice and accordance with the PRA, prior to individual’s name, address, email, recommendations to the Secretary of publication of any final guidance telephone number, professional or HHS (Secretary) on the development of document, FDA intends to solicit public organization affiliation, background or newborn screening activities, area of expertise (i.e., parent, family comment and obtain OMB approval for technologies, policies, guidelines, and any information collections member, researcher, clinician, public programs for effectively reducing health, etc.) and the topic/subject recommended in this guidance that are morbidity and mortality in newborns new or that would represent material matter. and children having, or at risk for, Individuals who plan to attend and modifications to those previously heritable disorders. In addition, need special assistance or another approved collections of information ACHDNC’s recommendations regarding reasonable accommodation should found in FDA regulations or guidances. inclusion of additional conditions for notify Ann Ferrero at the address and III. Electronic Access screening, following adoption by the phone number listed above at least 10 Secretary, are evidence-informed business days prior to the meeting. Persons with access to the internet preventive health services provided for Since this meeting occurs in a federal may obtain the draft guidance at either in the comprehensive guidelines government building, attendees must go https://www.fda.gov/Drugs/ supported by HRSA through the through a security check to enter the GuidanceCompliance Recommended Uniform Screening Panel building. Non-U.S. Citizens attendees RegulatoryInformation/Guidances/ (RUSP) pursuant to section 2713 of the planning to attend must notify HRSA of default.htm or https:// Public Health Service Act (42 U.S.C. their planned attendance at least 10 www.regulations.gov. 300gg–13). Under this provision, non- business days prior to the meeting in

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order to facilitate their entry into the government-issued photo ID, driver’s license, The VRC01-class of potent, broadly building. Contact Ann Ferrero using the or passport) and to state the purpose of their neutralizing antibodies (bnAbs) targets information mentioned above by visit. the conserved CD4-binding site (CD4bs) Information is also available on the Thursday, October 18, 2018, 12:00 p.m. Institute’s/Center’s home page: NCRA: http:// of HIV-1 Env which has been a major ET. All attendees are required to present deainfo.nci.nih.gov/advisory/ncra/ncra.htm, target of HIV-vaccine design. The government-issued identification prior where an agenda and any additional current best priming immunogen to to entry. The meeting will also be information for the meeting will be posted engage the VRC01-class germline accessible via webcast. Instructions on when available. precursors is the eOD-GT8 60mer, how to access the meeting via webcast (Catalogue of Federal Domestic Assistance which elicits VRC01-class precursors in will be provided upon registration. Program Nos. 93.392, Cancer Construction; multiple transgenic mouse models. 93.393, Cancer Cause and Prevention However, a large proportion of the Amy P. McNulty, Research; 93.394, Cancer Detection and antibodies elicited by eOD-GT8 60mer Acting Director, Division of the Executive Diagnosis Research; 93.395, Cancer are non-CD4bs or ‘‘off-target’’ Secretariat. Treatment Research; 93.396, Cancer Biology antibodies, undermining its [FR Doc. 2018–20428 Filed 9–19–18; 8:45 am] Research; 93.397, Cancer Centers Support; 93.398, Cancer Research Manpower; 93.399, effectiveness in eliciting the VRC01- BILLING CODE 4165–15–P Cancer Control, National Institutes of Health, class bnAb precursors. HHS) Researchers at the Vaccine Research Center (VRC) of the National Institute of DEPARTMENT OF HEALTH AND Dated: September 14, 2018. Allergy and Infectious Diseases HUMAN SERVICES Melanie J. Pantoja, introduced multiple N-linked Program Analyst, Office of Federal Advisory glycosylation sites to mask non-CD4bs National Institutes of Health Committee Policy. regions of eOD-GT8 60mer to focus the [FR Doc. 2018–20418 Filed 9–19–18; 8:45 am] National Cancer Institute; Notice of antibody immune response to the Meeting BILLING CODE 4140–01–P CD4bs. Several glycan-masked mutants Pursuant to section 10(d) of the showed significantly decreased DEPARTMENT OF HEALTH AND Federal Advisory Committee Act, as antibody binding to non-CD4bs ‘‘off- HUMAN SERVICES amended, notice is hereby given of a target’’ epitopes while maintaining meeting of the National Cancer Institute National Institutes of Health strong binding to CD4bs-specific bnAbs. Council of Research Advocates. Furthermore, in vivo studies showed The meeting will be open to the Government-Owned Inventions; that immunization with the best glycan- public, with attendance limited to space Availability for Licensing masked eOD-GT8 mutants resulted in available. Individuals who plan to significant increases in the elicitation of attend and need special assistance, such AGENCY: National Institutes of Health, CD4bs-specific serum antibodies, as sign language interpretation or other HHS. CD4bs-specific B cells in the spleen, and reasonable accommodations, should ACTION: Notice. VRC01-class precursors, compared to notify the Contact Person listed below immunization with the parental eOD- in advance of the meeting. The open SUMMARY: The invention listed below is owned by an agency of the U.S. GT8 immunogen. In conclusion, session will be videocast and can be because of their improved antigenic and accessed from the NIH Videocasting and Government and is available for licensing to achieve expeditious immunogenic profiles, glycan-masked Podcasting website (http:// eOD-GT8 60mer mutants may serve as videocast.nih.gov). commercialization of results of federally-funded research and improved priming immunogens to elicit Name of Committee: National Cancer development. Foreign patent VRC01-class bnAbs in humans. Institute Council of Research Advocates. applications are filed on selected Potential Commercial Applications: Date: October 19, 2018. • HIV-1 vaccine—the priming inventions to extend market coverage Time: 9:00 a.m. to 4:30 p.m. component in a prime-boost approach. Agenda: Welcome and Chairman’s for companies and may also be available Competitive Advantages: Remarks, NCI Updates, Legislative Update, for licensing. • Reduced off-target immunogenicity. Budget Update, and Director’s Update. FOR FURTHER INFORMATION CONTACT: • Improved efficacy in eliciting Place: National Institutes of Health, 35A Barry Buchbinder, Ph.D., 240–627– precursors for broadly neutralizing Convent Drive, Building 35A, 640, Bethesda, 3678; [email protected]. CD4bs antibodies. MD 20892. Licensing information and copies of the • Contact Person: Amy Williams, NCI Office Facilitates the development of of Advocacy Relations, National Cancer U.S. patent application listed below VRC01-class bnAbs in humans. Institute, NIH, 31 Center Drive, Building 31, may be obtained by communicating Development Stage: In vivo testing Room 10A28, Bethesda, MD 20892, 240–781– with the indicated licensing contact at (rodents). 3360 [email protected]. the Technology Transfer and Inventors: John R. Mascola (NIAID), Any interested person may file written Intellectual Property Office, National Hongying Duan (NIAID), Xuejun Chen comments with the committee by forwarding Institute of Allergy and Infectious (NIAID), Cheng Cheng (NIAID) and the statement to the Contact Person listed on Diseases, 5601 Fishers Lane, Rockville, Jeffrey C. Boyington (NIAID). this notice. The statement should include the MD 20852; tel. 301–496–2644. A signed Publications: Duan, H. et al., Glycan name, address, telephone number and when Confidential Disclosure Agreement will Masking Focuses Immune Responses to applicable, the business or professional be required to receive copies of the HIV-1 CD4-Binding Site and affiliation of the interested person. unpublished patent applications. Enhances Elicitation of VRC01-Class In the interest of security, NIH has Precursor Antibodies. Immunity 49, 301 instituted stringent procedures for entrance SUPPLEMENTARY INFORMATION: onto the NIH campus. All visitor vehicles, Technology description follows. (2018). Intellectual Property: HHS Reference including taxicabs, hotel, and airport shuttles Glycan-Masked Engineered Outer will be inspected before being allowed on Number E–083–2017 includes U.S. campus. Visitors will be asked to show one Domains of HIV-1 GP120 and Their Use Provisional Patent Application Number form of identification (for example, a Description of Technology: 62/476,397 filed 03/24/2017 and PCT

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Application Number PCT/US2018/ 672, Bethesda, MD 20892, zhanggu@ DEPARTMENT OF HEALTH AND 024330 filed 03/26/2018. mail.nih.gov. HUMAN SERVICES Licensing Contact: Barry Buchbinder, (Catalogue of Federal Domestic Assistance Ph.D., 240–627–3678; Program Nos. 93.121, Oral Diseases and National Institutes of Health [email protected]. Disorders Research, National Institutes of Health, HHS) Center for Scientific Review; Amended Dated: September 10, 2018. Dated: September 14, 2018. Notice of Meeting Suzanne M. Frisbie, Natasha M. Copeland, Deputy Director, Technology Transfer and Notice is hereby given of a change in Intellectual Property Office, National Institute Program Analyst, Office of Federal Advisory the meeting of the Molecular Genetics B of Allergy and Infectious Diseases. Committee Policy. Study Section, September 27, 2018, [FR Doc. 2018–20484 Filed 9–19–18; 8:45 am] [FR Doc. 2018–20424 Filed 9–19–18; 8:45 am] 10:00 a.m. to September 28, 2018, 06:00 BILLING CODE 4140–01–P BILLING CODE 4140–01–P p.m., National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD, 20892 which was published in the Federal DEPARTMENT OF HEALTH AND DEPARTMENT OF HEALTH AND Register on September 06, 2018, HUMAN SERVICES HUMAN SERVICES 83FR173 pg. 45264. National Institutes of Health The meeting will be held on National Institutes of Health September 27, 2018, starting at 8:30 a.m. National Institute of Dental & National Institute of Allergy and The meeting location remains the same. Craniofacial Research; Notice of Infectious Diseases; Notice of Closed The meeting is closed to the public. Closed Meetings Meeting Dated: September 14, 2018. Melanie J. Pantoja, Pursuant to section 10(d) of the Pursuant to section 10(d) of the Program Analyst, Office of Federal Advisory Federal Advisory Committee Act, as Federal Advisory Committee Act, as Committee Policy. amended, notice is hereby given of the amended, notice is hereby given of the [FR Doc. 2018–20415 Filed 9–19–18; 8:45 am] following meetings. following meeting. BILLING CODE 4140–01–P The meetings will be closed to the The meeting will be closed to the public in accordance with the public in accordance with the provisions set forth in section provisions set forth in sections DEPARTMENT OF HEALTH AND 552b(c)(6), Title 5 U.S.C., as amended. 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., HUMAN SERVICES The grant applications and the as amended. The grant applications and discussions could disclose confidential the discussions could disclose National Institutes of Health trade secrets or commercial property confidential trade secrets or commercial Center for Scientific Review; Notice of such as patentable material, and property such as patentable material, Closed Meetings personal information concerning and personal information concerning individuals associated with the grant individuals associated with the grant applications, the disclosure of which Pursuant to section 10(d) of the applications, the disclosure of which Federal Advisory Committee Act, as would constitute a clearly unwarranted would constitute a clearly unwarranted invasion of personal privacy. amended, notice is hereby given of the invasion of personal privacy. following meetings. Name of Committee: National Institute of Name of Committee: National Institute of The meetings will be closed to the Dental and Craniofacial Research Special Allergy and Infectious Diseases Special Emphasis Panel; DPBRN ARC. public in accordance with the Emphasis Panel Centers of Excellence for provisions set forth in sections Date: November 14, 2018. Translational Research (CETR) (U19). Time: 8:00 a.m. to 5:00 p.m. 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., Date: October 11–12, 2018. as amended. The grant applications and Agenda: To review and evaluate grant Time: 8:00 a.m. to 6:00 p.m. applications. Agenda: To review and evaluate grant the discussions could disclose Place: Hilton Garden Inn, 7301 Waverly applications. confidential trade secrets or commercial Street, Bethesda, MD 20814. Place: Doubletree Hotel Bethesda, property such as patentable material, Contact Person: Guo He Zhang, MPH, (Formerly Holiday Inn Select), 8120 and personal information concerning Ph.D., Scientific Review Officer, Scientific Wisconsin Avenue, Bethesda, MD 20814. individuals associated with the grant Review Branch, National Institute of Dental Contact Person: Yong Gao, Ph.D., Scientific and Craniofacial Research, National Institutes applications, the disclosure of which Review Officer Scientific Review Program, of Health, 6701 Democracy Boulevard, Suite would constitute a clearly unwarranted Division of Extramural Activities, Room 672, Bethesda, MD 20892, zhanggu@ invasion of personal privacy. #3G13B, National Institutes of Health/NIAID, mail.nih.gov. 5601 Fishers Lane, MSC 9823, Rockville, MD Name of Committee: Brain Disorders and Name of Committee: National Institute of 20892–7616, (240) 669–5048, yong.gao@ Clinical Neuroscience Integrated Review Dental and Craniofacial Research Special nih.gov. Group; Clinical Neuroscience and Emphasis Panel; DPBRN Coordinating Neurodegeneration Study Section. Center. (Catalogue of Federal Domestic Assistance Date: October 3–4, 2018. Date: November 14, 2018. Program Nos. 93.855, Allergy, Immunology, Time: 8:00 a.m. to 5:00 p.m. Time: 10:00 a.m. to 5:00 p.m. and Transplantation Research; 93.856, Agenda: To review and evaluate grant Agenda: To review and evaluate grant Microbiology and Infectious Diseases applications. applications. Research, National Institutes of Health, HHS) Place: National Institutes of Health, 6701 Place: Hilton Garden Inn Bethesda, 7301 Dated: September 14, 2018. Rockledge Drive, Bethesda, MD 20892. Waverly Street, Bethesda, MD 20814. Natasha M. Copeland, Contact Person: Alessandra C. Rovescalli, Contact Person: Guo He Zhang, MPH, Ph.D., Scientific Review Officer, National Program Analyst, Office of Federal Advisory Ph.D., Scientific Review Officer, Scientific Institutes of Health, Center for Scientific Committee Policy. Review Branch, National Institute of Dental Review, 6701 Rockledge Drive, Rm 5205 and Craniofacial Research, National Institutes [FR Doc. 2018–20421 Filed 9–19–18; 8:45 am] MSC7846, Bethesda, MD 20892, (301) 435– of Health, 6701 Democracy Boulevard, Suite BILLING CODE 4140–01–P 1021, [email protected].

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Name of Committee: Center for Scientific Contact Person: Sara Ahlgren, Ph.D., Agenda: To review and evaluate grant Review Special Emphasis Panel; PAR–15– Scientific Review Officer, Center for applications. 357: Understanding Alzheimer’s Disease in Scientific Review, National Institutes of Place: Courtyard Seattle Downtown the Context of the Aging Brain. Health, 6701 Rockledge Drive, RM 4136, Pioneer Square, 612 2nd Avenue, Seattle, Date: October 3, 2018. Bethesda, MD 20892, 301–435–0904, WA 98104. Time: 11:00 a.m. to 4:00 p.m. [email protected]. Contact Person: Karin F Helmers, Ph.D., Agenda: To review and evaluate grant Name of Committee: Oncology 1-Basic Scientific Review Officer, Center for applications. Translational Integrated Review Group; Scientific Review, National Institutes of Place: National Institutes of Health, 6701 Molecular Oncogenesis Study Section. Health, 6701 Rockledge Drive, Room 3166, Rockledge Drive, Bethesda, MD 20892, Date: October 15–16, 2018. MSC 7770, Bethesda, MD 20892, 301–254– (Virtual Meeting). Time: 8:00 a.m. to 5:00 p.m. 9975, [email protected]. Contact Person: Boris P. Sokolov, Ph.D., Agenda: To review and evaluate grant Name of Committee: Oncology 1-Basic Scientific Review Officer, Center for applications. Translational Integrated Review Group; Scientific Review, National Institutes of Place: Ritz-Carlton Hotel, 1700 Tysons Tumor Cell Biology Study Section. Health, 6701 Rockledge Drive, Room 5217A, Boulevard, McLean, VA 22102. Date: October 15–16, 2018. MSC 7846, Bethesda, MD 20892, 301–408– Contact Person: Nywana Sizemore, Ph.D., Time: 8:00 a.m. to 5:00 p.m. 9115, [email protected]. Scientific Review Officer, Center for Agenda: To review and evaluate grant Name of Committee: Center for Scientific Scientific Review, National Institutes of applications. Review Special Emphasis Panel; Health, 6701 Rockledge Drive, Room 6204, Place: Hilton Alexandria Old Town, 1767 Biostatistical Methods and Research Design. MSC 7804, Bethesda, MD 20892, 301–435– King Street, Alexandria, VA 22314. Date: October 4, 2018. 1718, [email protected]. Contact Person: Charles Morrow, MD, Ph.D., Scientific Review Officer, Center for Time: 2:00 p.m. to 3:00 p.m. Name of Committee: Cell Biology Scientific Review, National Institutes of Agenda: To review and evaluate grant Integrated Review Group; Development—2 Health, 6701 Rockledge Drive, Room 6202, applications. Study Section. MSC 7804, Bethesda, MD 20892, 301–408– Place: Washington Plaza Hotel, 10 Thomas Date: October 15–16, 2018. 9850, [email protected]. Circle NW, Washington, DC 20005. Time: 8:00 a.m. to 12:00 p.m. Contact Person: Denise Wiesch, Ph.D., Agenda: To review and evaluate grant Name of Committee: Musculoskeletal, Oral Scientific Review Officer, Center for applications. and Skin Sciences Integrated Review Group; Scientific Review, National Institutes of Place: Embassy Suites at the Chevy Chase Arthritis, Connective Tissue and Skin Study Health, 6701 Rockledge Drive, Room 3138, Pavilion, 4300 Military Road NW, Section. MSC 7770, Bethesda, MD 20892, (301) 437– Washington, DC 20015. Date: October 15–16, 2018. 3478, [email protected]. Contact Person: Rass M Shayiq, Ph.D., Time: 8:00 a.m. to 5:00 p.m. Agenda: To review and evaluate grant Name of Committee: Molecular, Cellular Scientific Review Officer, Center for Scientific Review, National Institutes of applications. and Developmental Neuroscience Integrated Place: Doubletree Hotel Bethesda, Review Group; Biophysics of Neural Systems Health, 6701 Rockledge Drive, Room 2182, MSC 7818, Bethesda, MD 20892, (301) 435– (Formerly Holiday Inn Select), 8120 Study Section. Wisconsin Avenue, Bethesda, MD 20814. 2359, [email protected]. Date: October 11–12, 2018. Contact Person: Alexey Belkin, Ph.D., Time: 8:00 a.m. to 2:00 p.m. Name of Committee: Brain Disorders and Scientific Review Officer, Center for Agenda: To review and evaluate grant Clinical Neuroscience Integrated Review Scientific Review, National Institutes of applications. Group; Brain Injury and Neurovascular Health, 6701 Rockledge Drive, Room 4102, Place: Hotel Monaco Baltimore, 2 N Pathologies Study Section. Bethesda, MD 20817, 301–435–1786, Charles, Baltimore, MD 21201. Date: October 15–16, 2018. [email protected]. Contact Person: Geoffrey G. Schofield, Time: 8:00 a.m. to 5:00 p.m. Name of Committee: Infectious Diseases Ph.D., Scientific Review Officer, Center for Agenda: To review and evaluate grant and Microbiology Integrated Review Group; Scientific Review, National Institutes of applications. Vector Biology Study Section. Health, 6701 Rockledge Drive, Room 4040–A, Place: Embassy Suites at the Chevy Chase Date: October 15–16, 2018. MSC 7850, Bethesda, MD 20892, 301–435– Pavilion, 4300 Military Road NW, Time: 8:30 a.m. to 1:00 p.m. 1235, [email protected]. Washington, DC 20015. Agenda: To review and evaluate grant Name of Committee: Brain Disorders and Contact Person: Alexander Yakovlev, applications. Clinical Neuroscience Integrated Review Ph.D., Scientific Review Officer, Center for Place: The River Inn, 924 25th Street NW, Group; Clinical Neuroimmunology and Brain Scientific Review, National Institutes of Washington, DC 20037. Tumors Study Section. Health, 6701 Rockledge Drive, Room 5206, Contact Person: Liangbiao Zheng, Ph.D., Date: October 11–12, 2018. MSC 7846, Bethesda, MD 20892, 301–435– Scientific Review Officer, Center for Time: 8:00 a.m. to 5:00 p.m. 1254, [email protected]. Scientific Review, National Institutes of Agenda: To review and evaluate grant Name of Committee: Brain Disorders and Health, 6701 Rockledge Drive, Room 3214, applications. Clinical Neuroscience Integrated Review MSC 7808, Bethesda, MD 20892, 301–402– Place: Doubletree Hotel Bethesda, Group; Chronic Dysfunction and Integrative 5671, [email protected]. (Formerly Holiday Inn Select), 8120 Neurodegeneration Study Section. Name of Committee: Infectious Diseases Wisconsin Avenue, Bethesda, MD 20814. Date: October 15–16, 2018. and Microbiology Integrated Review Group; Contact Person: Wei-Qin Zhao, Ph.D., Time: 8:00 a.m. to 5:00 p.m. Clinical Research and Field Studies of Scientific Review Officer, Center for Agenda: To review and evaluate grant Infectious Diseases Study Section. Scientific Review, National Institutes of applications. Date: October 15–16, 2018. Health, 6701 Rockledge Drive, Room 5181, Place: Residence Inn Bethesda, 7335 Time: 8:30 a.m. to 5:00 p.m. MSC 7846, Bethesda, MD 20892–7846, 301– Wisconsin Avenue, Bethesda, MD 20814. Agenda: To review and evaluate grant 435–1236, [email protected]. Contact Person: Alexei Kondratyev, Ph.D., applications. Name of Committee: Cardiovascular and Scientific Review Officer, Center for Place: Crowne Plaza Chicago West Loop, Respiratory Sciences Integrated Review Scientific Review, National Institutes of 733 West Madison, Chicago, IL 60661. Group; Electrical Signaling, Ion Transport, Health, 6701 Rockledge Drive, Room 5200, Contact Person: Soheyla Saadi, Ph.D., and Arrhythmias Study Section. MSC 7846, Bethesda, MD 20892, 301–435– Scientific Review Officer, Center for Date: October 11, 2018. 1785, [email protected]. Scientific Review, National Institutes of Time: 8:00 a.m. to 6:00 p.m. Name of Committee: Center for Scientific Health, 6701 Rockledge Drive, Room 3211, Agenda: To review and evaluate grant Review Special Emphasis Panel; Societal and MSC 7808, Bethesda, MD 20892, 301–435– applications. Ethical Issues in Research. 0903, [email protected]. Place: Bethesda Marriott, 5151 Pooks Hill Date: October 15, 2018. (Catalogue of Federal Domestic Assistance Road, Bethesda, MD 20814. Time: 8:00 a.m. to 5:00 p.m. Program Nos. 93.306, Comparative Medicine;

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93.333, Clinical Research, 93.306, 93.333, DEPARTMENT OF HEALTH AND Name of Committee: Cell Biology 93.337, 93.393–93.396, 93.837–93.844, HUMAN SERVICES Integrated Review Group; Nuclear and 93.846–93.878, 93.892, 93.893, National Cytoplasmic Structure/Function and Institutes of Health, HHS) National Institutes of Health Dynamics Study Section. Date: October 11, 2018. Dated: September 14, 2018. Time: 8:00 a.m. to 7:00 p.m. Natasha M. Copeland, Center for Scientific Review; Notice of Closed Meetings Agenda: To review and evaluate grant Program Analyst, Office of Federal Advisory applications. Committee Policy. Pursuant to section 10(d) of the Place: Canopy Washington DC Bethesda [FR Doc. 2018–20413 Filed 9–19–18; 8:45 am] Federal Advisory Committee Act, as North, 940 Rose Avenue, North Bethesda, MD 20852. BILLING CODE 4140–01–P amended, notice is hereby given of the Contact Person: Jessica Smith, Ph.D., following meetings. Scientific Review Officer, Center for The meetings will be closed to the DEPARTMENT OF HEALTH AND Scientific Review, National Institutes of public in accordance with the Health, 6701 Rockledge Drive, Bethesda, MD HUMAN SERVICES provisions set forth in sections 20892, [email protected]. 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., National Institutes of Health Name of Committee: Population Sciences as amended. The grant applications and and Epidemiology Integrated Review Group; National Institute of General Medical the discussions could disclose Kidney, Nutrition, Obesity and Diabetes Sciences; Notice of Closed Meeting confidential trade secrets or commercial Study Section. property such as patentable material, Date: October 11–12, 2018. Pursuant to section 10(d) of the and personal information concerning Time: 8:00 a.m. to 6:00 p.m. Federal Advisory Committee Act, as individuals associated with the grant Agenda: To review and evaluate grant amended, notice is hereby given of the applications, the disclosure of which applications. following meeting. Place: Melrose Hotel, 2430 Pennsylvania would constitute a clearly unwarranted Ave. NW, Washington, DC 20037. The meeting will be closed to the invasion of personal privacy. Contact Person: Fungai Chanetsa, Ph.D., public in accordance with the Name of Committee: Center for Scientific MPH, Scientific Review Officer, Center for provisions set forth in sections Review Special Emphasis Panel; RFA Panel: Scientific Review, National Institutes of 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., Tobacco Regulatory Science—Basic Science. Health, 6701 Rockledge Drive, Room 3135, as amended. The grant applications and Date: October 2, 2018. MSC 7770, Bethesda, MD 20892, 301–408– the discussions could disclose Time: 10:00 a.m. to 6:00 p.m. 9436, [email protected]. confidential trade secrets or commercial Agenda: To review and evaluate grant Name of Committee: Surgical Sciences, property such as patentable material, applications. Biomedical Imaging and Bioengineering and personal information concerning Place: National Institutes of Health, 6701 Integrated Review Group; Clinical Molecular Rockledge Drive, Bethesda, MD 20892 Imaging and Probe Development. individuals associated with the grant (Virtual Meeting). applications, the disclosure of which Date: October 11–12, 2018. Contact Person: Joseph Thomas Peterson, Time: 8:00 a.m. to 5:00 p.m. would constitute a clearly unwarranted Ph.D., Scientific Review Officer, Center for Agenda: To review and evaluate grant invasion of personal privacy. Scientific Review, National Institutes of applications. Health, 6701 Rockledge Drive, Room 4118, Name of Committee: National Institute of Place: Hilton Alexandria Mark Center, MSC 7814, Bethesda, MD 20892, 301–408– General Medical Sciences Special Emphasis 5000 Seminary Road, Alexandria, VA 22311. 9694, [email protected]. Panel; Review of Support of Competitive Contact Person: Donald Scott Wright, Research (SCORE) Award Applications. Name of Committee: Healthcare Delivery Ph.D., Scientific Review Officer, Center for Date: November 2, 2018. and Methodologies Integrated Review Group; Scientific Review, National Institutes of Time: 8:00 a.m. to 5:00 p.m. Dissemination and Implementation Research Health, 6701 Rockledge Drive, Room 5108, Agenda: To review and evaluate grant in Health Study Section. MSC 7854, Bethesda, MD 20892, (301) 435– applications Date: October 10–11, 2018. 8363, [email protected]. Place: Cambria Suites Rockville, 1 Helen Time: 8:00 a.m. to 6:00 p.m. Agenda: To review and evaluate grant Name of Committee: Population Sciences Heneghan Way, Rockville, MD 20850. and Epidemiology Integrated Review Group; Contact Person: Shinako Takada, Ph.D., applications. Place: Capitol Skyline Hotel, 10 I St. SW, Neurological, Aging and Musculoskeletal Scientific Review Officer, Office of Scientific Epidemiology Study Section. Review, National Institute of General Medical Washington, DC 20024. Contact Person: Yvonne Owens Ferguson, Date: October 11–12, 2018. Sciences, National Institutes of Health, 45 Time: 8:00 a.m. to 6:00 p.m. Center Drive, Room 3An.22, Bethesda, MD Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Agenda: To review and evaluate grant 20892–6200, 301–402–9448, applications. [email protected]. Health, 6701 Rockledge Drive, Room 3139, Bethesda, MD 20892, 301–827–3689, Place: Residence Inn by Marriott Arlington (Catalogue of Federal Domestic Assistance [email protected]. Pentagon City, 550 Army Navy Dr., Program Nos. 93.375, Minority Biomedical Name of Committee: Center for Scientific Arlington, VA 22202. Research Support; 93.821, Cell Biology and Review Special Emphasis Panel; PAR–17– Contact Person: Heidi B. Friedman, Ph.D., Biophysics Research; 93.859, Pharmacology, 094: Maximizing Investigators’ Research Scientific Review Officer, Center for Physiology, and Biological Chemistry Award (R35). Scientific Review, National Institutes of Research; 93.862, Genetics and Date: October 10, 2018. Health, 6701 Rockledge Drive, Room 1012A, Developmental Biology Research; 93.88, Time: 8:00 a.m. to 5:00 p.m. MSC 7770, Bethesda, MD 20892, 301–435– Minority Access to Research Careers; 93.96, Agenda: To review and evaluate grant 1721, [email protected]. Special Minority Initiatives; 93.859, applications. Name of Committee: Endocrinology, Biomedical Research and Research Training, Place: Residence Inn Capital View, 2850 Metabolism, Nutrition and Reproductive National Institutes of Health, HHS) South Potomac Avenue, Arlington, VA Sciences Integrated Review Group; Molecular Dated: September 14, 2018. 22202. and Cellular Endocrinology Study Section. Melanie J. Pantoja, Contact Person: Maqsood A. Wani, Ph.D., Date: October 11–12, 2018. Scientific Review Officer, Center for Time: 8:00 a.m. to 5:00 p.m. Program Analyst, Office of Federal Advisory Scientific Review, National Institutes of Agenda: To review and evaluate grant Committee Policy. Health, 6701 Rockledge Drive, Room 2114, applications. [FR Doc. 2018–20425 Filed 9–19–18; 8:45 am] MSC 7814, Bethesda, MD 20892, 301–435– Place: Lorien Hotel & Spa, 1600 King BILLING CODE 4140–01–P 2270, [email protected]. Street, Alexandria, VA 22314.

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Contact Person: Liliana Norma Berti- and personal information concerning provisions set forth in sections Mattera, Ph.D., Scientific Review Officer, individuals associated with the contract 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., Center for Scientific Review, National proposals, the disclosure of which as amended. The grant applications and Institutes of Health, 6701 Rockledge Drive, would constitute a clearly unwarranted the discussions could disclose Room 4215, Bethesda, MD 20892, [email protected]. invasion of personal privacy. confidential trade secrets or commercial property such as patentable material, Name of Committee: Healthcare Delivery Name of Committee: National Institute on and Methodologies Integrated Review Group; Drug Abuse Special Emphasis Panel; State-of- and personal information concerning Community-Level Health Promotion Study the-Art Functional MRI Approaches individuals associated with the grant Section. Combined with MVPA (9916). applications, the disclosure of which Date: October 15–16, 2018. Date: October 4, 2018. would constitute a clearly unwarranted Time: 8:00 a.m. to 6:00 p.m. Time: 10:00 a.m. to 12:00 p.m. invasion of personal privacy. Agenda: To review and evaluate grant Agenda: To review and evaluate contract applications. proposals. Name of Committee: Microbiology, Place: Westin Georgetown, 2350 M Street, Place: National Institutes of Health, Infectious Diseases and AIDS Initial Review Group; Microbiology and Infectious Diseases NW, Washington, DC 20037. Neuroscience Center, 6001 Executive Research Committee. Contact Person: Ping Wu, Ph.D., Scientific Boulevard, Rockville, MD 20852 (Telephone Date: October 18–19, 2018. Review Officer, Center for Scientific Review, Conference Call). Time: 8:00 a.m. to 5:30 p.m. National Institutes of Health, 6701 Rockledge Contact Person: Lyle Furr, Scientific Agenda: To review and evaluate grant Drive, Room 3166, Bethesda, MD 20892, 301– Review Officer, Office of Extramural Affairs, applications. 451–8428 [email protected]. National Institute on Drug Abuse, NIH, Place: National Institutes of Health, 5601 Name of Committee: Center for Scientific DHHS, Room 4227, MSC 9550, 6001 Fishers Lane, Rockville, MD 20892 Review Special Emphasis Panel; RFA–GM– Executive Boulevard, Bethesda, MD 20892– (Telephone Conference Call). 18–002: Training Modules to Enhance the 9550, (301) 827–5702, lf33c.nih.gov. Contact Person: Amir E. Zeituni, Ph.D., Rigor and Reproducibility of Biomedical Name of Committee: National Institute on Scientific Review Program, Division of Research (R25). Drug Abuse Special Emphasis Panel; Extramural Activities, SRP, RM 3G51 Date: October 16, 2018. Assessment of Potential Substance Abuse National Institutes of Health, NIAID, 5601 Time: 10:00 a.m. to 3:00 p.m. Treatment Medications in Nonhuman Fishers Lane, MSC 9823, Rockville, MD Agenda: To review and evaluate grant Primate Models (8946). 20852–9823, 301–496–2550, amir.zeituni@ applications. Date: October 18, 2018. nih.gov. Place: National Institutes of Health, 6701 Time: 10:00 a.m. to 12:00 p.m. (Catalogue of Federal Domestic Assistance Rockledge Drive, Bethesda, MD 20892 Agenda: To review and evaluate contract Program Nos. 93.855, Allergy, Immunology, (Virtual Meeting). proposals. and Transplantation Research; 93.856, Contact Person: Vonda K. Smith, Ph.D., Place: National Institutes of Health, Microbiology and Infectious Diseases Scientific Review Officer, Center for Neuroscience Center, 6001 Executive Research, National Institutes of Health, HHS) Scientific Review, National Institutes of Boulevard, Rockville, MD 20852 (Telephone Health, 6701 Rockledge Drive, Room 6188, Conference Call). Dated: September 14, 2018. MSC 7892, Bethesda, MD 20892, 301–435– Contact Person: Lyle Furr, Scientific Natasha M. Copeland, 1789, [email protected]. Review Officer, Office of Extramural Affairs, Program Analyst, Office of Federal Advisory (Catalogue of Federal Domestic Assistance National Institute on Drug Abuse, NIH, Committee Policy. Program Nos. 93.306, Comparative Medicine; DHHS, Room 4227, MSC 9550, 6001 [FR Doc. 2018–20422 Filed 9–19–18; 8:45 am] 93.333, Clinical Research, 93.306, 93.333, Executive Boulevard, Bethesda, MD 20892– BILLING CODE 4140–01–P 93.337, 93.393–93.396, 93.837–93.844, 9550, (301) 827–5702, f33c.nih.gov. 93.846–93.878, 93.892, 93.893, National (Catalogue of Federal Domestic Assistance Institutes of Health, HHS) Program No.: 93.279, Drug Abuse and DEPARTMENT OF HEALTH AND Dated: September 14, 2018. Addiction Research Programs, National HUMAN SERVICES Institutes of Health, HHS) Melanie J. Pantoja, Program Analyst, Office of Federal Advisory Dated: September 14, 2018. National Institutes of Health Committee Policy. Natasha M. Copeland, National Institute on Drug Abuse; [FR Doc. 2018–20414 Filed 9–19–18; 8:45 am] Program Analyst, Office of Federal Advisory Notice of Closed Meetings BILLING CODE 4140–01–P Committee Policy. [FR Doc. 2018–20417 Filed 9–19–18; 8:45 am] Pursuant to section 10(d) of the BILLING CODE 4140–01–P Federal Advisory Committee Act, as DEPARTMENT OF HEALTH AND amended, notice is hereby given of the HUMAN SERVICES following meetings. DEPARTMENT OF HEALTH AND The meetings will be closed to the National Institutes of Health HUMAN SERVICES public in accordance with the provisions set forth in sections National Institute on Drug Abuse; National Institutes of Health 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., Notice of Closed Meetings as amended. The grant applications and National Institute of Allergy and the discussions could disclose Pursuant to section 10(d) of the Infectious Diseases Notice of Closed confidential trade secrets or commercial Federal Advisory Committee Act, as Meeting amended, notice is hereby given of the property such as patentable material, following meetings. Pursuant to section 10(d) of the and personal information concerning The meetings will be closed to the Federal Advisory Committee Act, as individuals associated with the grant public in accordance with the amended, notice is hereby given of a applications, the disclosure of which provisions set forth in sections meeting Microbiology, Infectious would constitute a clearly unwarranted 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., Diseases and AIDS Initial Review Group invasion of personal privacy. as amended. The contract proposals and Microbiology and Infectious Diseases Name of Committee: National Institute on the discussions could disclose Research Committee. Drug Abuse Special Emphasis Panel; confidential trade secrets or commercial The meeting will be closed to the Exploiting Omics Assays to Investigate property such as patentable material, public in accordance with the Molecular Regulation of Persistent HIV in

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Individuals with Substance Use Disorder DEPARTMENT OF HEALTH AND Addressing Harassment and (R61/R33 Clinical Trial Optional). HUMAN SERVICES Inappropriate Conduct and a new Policy Date: October 3, 2018. Statement addressing Personal Time: 12:00 p.m. to 4:30 p.m. National Institutes of Health Relationships in the Workplace. These Agenda: To review and evaluate grant policies apply to federal employees, applications. National Institute on Aging; Notice of contractors, trainees, and fellows who Place: National Institutes of Health, Closed Meeting perform work for the NIH. The NIH Neuroscience Center, 6001 Executive Pursuant to section 10(d) of the expects that organizations receiving NIH Boulevard, Rockville, MD 20852 (Telephone funds have in place similarly rigorous Conference Call). Federal Advisory Committee Act, as amended, notice is hereby given of the policies and related procedures for their Contact Person: Ipolia R. Ramadan, Ph.D., employees, contractors, trainees, and Scientific Review Officer, Office of following meeting. fellows who engage in agency-funded Extramural Policy and Review, Division of The meeting will be closed to the Extramural Research, National Institute on public in accordance with the activities. Drug Abuse, NIH, DHHS, 6001 Executive provisions set forth in sections FOR FURTHER INFORMATION CONTACT: For Boulevard, Room 4228, MSC 9550, Bethesda, 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., further information about these new MD 20892, 301–827–5842, ramadanir@ as amended. The grant applications and policies, contact Jessica Hawkins, Office mail.nih.gov. the discussions could disclose of Human Resources, National Institutes Name of Committee: National Institute on confidential trade secrets or commercial of Health, Building 31, Room 1/B37, Drug Abuse Special Emphasis Panel; property such as patentable material, Bethesda, Maryland 20892, telephone Exploring Epigenomic or Non-Coding RNA and personal information concerning 301–402–8006 (not a toll-free number), Regulation in the Development, individuals associated with the grant [email protected]. Maintenance, or Treatment of Chronic Pain applications, the disclosure of which SUPPLEMENTARY INFORMATION: Policy (R61/R33 Clinical Trial Optional). would constitute a clearly unwarranted Manual 1311—Preventing and Date: October 12, 2018. invasion of personal privacy. Addressing Harassment and Time: 12:00 p.m. to 4:00 p.m. Inappropriate Conduct states that the Agenda: To review and evaluate grant Name of Committee: National Institute on Aging Special Emphasis Panel; Institutional NIH will not tolerate inappropriate applications. Training Grants. Place: National Institutes of Health, conduct or harassment, including sexual Date: October 17, 2018. harassment. Timely and appropriate Neuroscience Center, 6001 Executive Time: 9:00 a.m. to 1:00 p.m. Boulevard, Rockville, MD 20852 (Telephone action will be taken against any Agenda: To review and evaluate grant individual found to be in violation of Conference Call). applications. Contact Person: Ipolia R. Ramadan, Ph.D., Place: Hyatt Regency Bethesda, One the policy outlined in the Manual Scientific Review Officer, Office of Bethesda Metro Center, 7400 Wisconsin Chapter. Through enforcement of this Extramural Policy and Review, Division of Avenue, Bethesda, MD 20814. policy, the NIH seeks to prevent, Extramural Research, National Institute on Contact Person: Kimberly Firth, Ph.D., correct, and eliminate unacceptable Drug Abuse, NIH, DHHS, 6001 Executive National Institutes of Health, National behavior that is inconsistent with the Boulevard, Room 4228, MSC 9550, Bethesda, Institute on Aging, Gateway Building, 7201 values and culture of respect and MD 20892, 301–827–5842, ramadanir@ Wisconsin Avenue, Suite 2C212, Bethesda, inclusion. Further, the policy is mail.nih.gov. MD 20892, 301–402–7702, firthkm@ intended to increase the transparency Name of Committee: National Institute on mail.nih.gov. and consistency in how allegations of Drug Abuse Special Emphasis Panel; (Catalogue of Federal Domestic Assistance harassment are reviewed and resolved. Coordinating Center to Support NIDA Rural Program Nos. 93.866, Aging Research, NIH leadership has designated the National Institutes of Health, HHS) Opioid HIV and Comorbidity Initiative Office of Human Resources’ Civil (U24—Clinical Trial Not Allowed). Dated: September 14, 2018. Program as the entity charged with Date: October 17, 2018. Melanie J. Pantoja, receiving allegations of harassment and Time: 2:00 p.m. to 4:30 p.m. Program Analyst, Office of Federal Advisory overseeing relevant administrative Agenda: To review and evaluate Committee Policy. inquiries. cooperative agreement applications. [FR Doc. 2018–20420 Filed 9–19–18; 8:45 am] The NIH Policy Statement on Personal Place: National Institutes of Health, BILLING CODE 4140–01–P Relationships in the Workplace states Neuroscience Center, 6001 Executive that personal relationships (including Boulevard, Rockville, MD 20852 (Telephone romantic and/or sexual) between Conference Call). DEPARTMENT OF HEALTH AND Contact Person: Hiromi Ono, Ph.D., individuals in inherently unequal Scientific Review Officer, Office of HUMAN SERVICES positions, where one party has real or perceived authority over the other in Extramural Policy and Review, National National Institutes of Health Institute on Drug Abuse, National Institutes their professional roles, may be of Health, DHHS, 6001 Executive Boulevard, inappropriate in the workplace and are Notice of New NIH Policy Manual strongly discouraged. If such a Room 4238, MSC 9550, Bethesda, MD 20892, 1311—Preventing and Addressing 301–827–5820, [email protected]. relationship exists or develops, it must Harassment and Inappropriate be disclosed. Upon such notification, (Catalogue of Federal Domestic Assistance Conduct and New Policy Statement on Program Nos.: 93.279, Drug Abuse and the responsible agency official must Inappropriate Relationships in the insure that the NIH Institute/Center Addiction Research Programs, National Workplace Institutes of Health, HHS) manages, decreases, or eliminates potential risk as a result of the Dated: September 14, 2018. AGENCY: National Institutes of Health, HHS. relationship. Natasha M. Copeland, ACTION: Notice. This applies to all individuals in the Program Analyst, Office of Federal Advisory NIH community, including employees, Committee Policy. SUMMARY: The National Institutes of contractors, students, trainees, and [FR Doc. 2018–20423 Filed 9–19–18; 8:45 am] Health (NIH) announces Policy Manual fellows and includes anyone who holds BILLING CODE 4140–01–P Chapter: 1311—Preventing and a position of authority or perceived

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authority over another individual from Name of Committee: National Cancer Contact Person: Craig Giroux, Ph.D., a scientific or administrative Institute Special Emphasis Panel; Scientific Review Officer, BST IRG, Center perspective. Investigation of the Transmission of Kaposi for Scientific Review, National Institutes of Sarcoma-Associated Herpesvirus. Health, 6701 Rockledge Drive, Room 5150, Dated: September 17, 2018. Date: November 14, 2018. Bethesda, MD 20892, 301–435–2204, Francis S. Collins, Time: 12:30 p.m. to 4:30 p.m. [email protected]. Director, National Institutes of Health. Agenda: To review and evaluate grant Name of Committee: Vascular and applications. [FR Doc. 2018–20505 Filed 9–19–18; 8:45 am] Hematology Integrated Review Group; Place: National Cancer Institute, Shady Hemostasis and Thrombosis Study Section. BILLING CODE 4140–01–P Grove, 9609 Medical Center Drive, Room Date: October 18, 2018. 7W238, Rockville, MD 20850 (Telephone Time: 8:00 a.m. to 6:00 p.m. Conference Call). Agenda: To review and evaluate grant DEPARTMENT OF HEALTH AND Contact Person: Byeong-Chel Lee, Ph.D., applications. HUMAN SERVICES Scientific Review Officer, Resources and Place: Hyatt Regency Bethesda, One Training Review Branch, Division of Bethesda Metro Center, 7400 Wisconsin National Institutes of Health Extramural Activities, National Cancer Avenue, Bethesda, MD 20814. Institute, NIH, 9609 Medical Center Drive, Contact Person: Bukhtiar H Shah, DVM, National Cancer Institute Notice of Room 7W238, Bethesda, MD 20892–9750, Ph.D., Scientific Review Officer, Vascular Closed Meetings 240–276–7755, [email protected]. and Hematology IRG, Center for Scientific (Catalogue of Federal Domestic Assistance Review, National Institutes of Health, 6701 Pursuant to section 10(d) of the Program Nos. 93.392, Cancer Construction; Rockledge Drive, Room 4120, MSC 7802, Bethesda, MD 20892, (301) 806–7314, Federal Advisory Committee Act, as 93.393, Cancer Cause and Prevention [email protected]. amended, notice is hereby given of the Research; 93.394, Cancer Detection and following meetings. Diagnosis Research; 93.395, Cancer Name of Committee: Infectious Diseases Treatment Research; 93.396, Cancer Biology and Microbiology Integrated Review Group; The meetings will be closed to the Research; 93.397, Cancer Centers Support; Host Interactions with Bacterial Pathogens public in accordance with the 93.398, Cancer Research Manpower; 93.399, Study Section. provisions set forth in sections Cancer Control, National Institutes of Health, Date: October 18–19, 2018. 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., HHS) Time: 8:00 a.m. to 3:00 p.m. as amended. The grant applications and Agenda: To review and evaluate grant Dated: September 14, 2018. applications. the discussions could disclose Melanie J. Pantoja, Place: Warwick Denver, 1776 Grant Street, confidential trade secrets or commercial Denver, CO 80203. property such as patentable material, Program Analyst, Office of Federal Advisory Committee Policy. Contact Person: Fouad A El-Zaatari, Ph.D., and personal information concerning Scientific Review Officer, Center for individuals associated with grant [FR Doc. 2018–20419 Filed 9–19–18; 8:45 am] Scientific Review, National Institutes of applications, the disclosure of which BILLING CODE 4140–01–P Health, 6701 Rockledge Drive, Room 3186, would constitute a clearly unwarranted MSC 7808, Bethesda, MD 20892, (301) 435– invasion of personal privacy. 1149, [email protected]. DEPARTMENT OF HEALTH AND Name of Committee: Musculoskeletal, Oral Name of Committee: National Cancer HUMAN SERVICES and Skin Sciences Integrated Review Group; Institute Special Emphasis Panel; Innovative Oral, Dental and Craniofacial Sciences Study Molecular and Cellular Analysis National Institutes of Health Section. Technologies (IMAT). Date: October 18–19, 2018. Date: October 19, 2018. Center for Scientific Review; Notice of Time: 8:00 a.m. to 12:00 p.m. Time: 8:30 a.m. to 5:30 p.m. Closed Meetings Agenda: To review and evaluate grant Agenda: To review and evaluate grant applications. applications. Pursuant to section 10(d) of the Place: Residence Inn Capital View, 2850 Place: National Cancer Institute, Shady Federal Advisory Committee Act, as South Potomac Avenue, Arlington, VA Grove, 9609 Medical Center Drive, Room amended, notice is hereby given of the 22202. 2E908, Rockville, MD 20850 (Telephone following meetings. Contact Person: Yi-Hsin Liu, Ph.D., Conference Call). The meetings will be closed to the Scientific Review Officer, Center for Contact Person: Jeffrey E. DeClue, Ph.D., Scientific Review, National Institutes of Scientific Review Officer, Research public in accordance with the Health, 6701 Rockledge Drive, Room 4214, Technology and Contract Review Branch, provisions set forth in sections MSC 7814, Bethesda, MD 20892, 301–435– Division of Extramural Activities, National 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., 1781, [email protected]. Cancer Institute, NIH, 9609 Medical Center as amended. The grant applications and Name of Committee: Center for Scientific Drive, Room 7W114, Bethesda, MD 20892– the discussions could disclose Review Special Emphasis Panel; 9750, 240–276–5287, [email protected]. confidential trade secrets or commercial Fellowships: Neurodevelopment, Synaptic Name of Committee: National Cancer property such as patentable material, Plasticity and Neurodegeneration. Institute Special Emphasis Panel; Cancer and personal information concerning Date: October 18–19, 2018. Systems Biology. individuals associated with the grant Time: 8:00 a.m. to 5:00 p.m. Date: November 1, 2018. applications, the disclosure of which Agenda: To review and evaluate grant applications. Time: 8:00 a.m. to 4:00 p.m. would constitute a clearly unwarranted Agenda: To review and evaluate grant Place: Doubletree Hotel Bethesda, applications. invasion of personal privacy. (Formerly Holiday Inn Select), 8120 Place: Embassy Suites at the Chevy Chase Name of Committee: Bioengineering Wisconsin Avenue, Bethesda, MD 20814. Pavilion, 5335 Wisconsin Ave. NW, Sciences & Technologies Integrated Review Contact Person: Mary Schueler, Ph.D., Washington, DC 20015. Group; Modeling and Analysis of Biological Scientific Review Officer, Center for Contact Person: Eun Ah Cho, Ph.D., Systems Study Section. Scientific Review, National Institutes of Scientific Review Officer, Special Review Date: October 18–19, 2018. Health, 6701 Rockledge Drive, Room 5214, Branch, Division of Extramural Activities, Time: 8:00 a.m. to 5:00 p.m. MSC 7846, Bethesda, MD 20892, 301–451– National Cancer Institute, NIH, 9609 Medical Agenda: To review and evaluate grant 0996, [email protected]. Center Drive, Room 7W124, Bethesda, MD applications. Name of Committee: Center for Scientific 20892–9750, 240–276–6342, choe@ Place: The William F. Bolger Center, 9600 Review Special Emphasis Panel; Fellowship: mail.nih.gov. Newbridge Drive, Potomac, MD 20854. Behavioral Neuroscience.

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Date: October 18–19, 2018. Contact Person: John Burch, Ph.D., Time: 8:00 a.m. to 12:00 p.m. Time: 8:00 a.m. to 5:00 p.m. Scientific Review Officer, Center for Agenda: To review and evaluate grant Agenda: To review and evaluate grant Scientific Review, National Institute of applications. applications. Health, 6701 Rockledge Drive, Room 3213, Place: Melrose Hotel, 2430 Pennsylvania Place: Embassy Suites DC Convention MSC 7808, Bethesda, MD 20892, 301–408– Ave. NW, Washington, DC 20037. Center, 900 10th Street NW, Washington, DC 9519, [email protected]. Contact Person: Chee Lim, Ph.D., Scientific 20001. Name of Committee: Oncology 2— Review Officer, Center for Scientific Review, Contact Person: Mei Qin, MD, Ph.D., Translational Clinical Integrated Review National Institutes of Health, 6701 Rockledge Scientific Review Officer, Center for Group; Cancer Biomarkers Study Section. Drive, Room 4128, Bethesda, MD 20892, 301– Scientific Review, National Institutes of Date: October 18–19, 2018. 435–1850, [email protected]. Health, 6701 Rockledge Drive, Room 5213, Time: 8:00 a.m. to 5:00 p.m. Name of Committee: Endocrinology, Bethesda, MD 20892, 301–875–2215, Agenda: To review and evaluate grant Metabolism, Nutrition and Reproductive [email protected]. applications. Sciences Integrated Review Group; Clinical Name of Committee: Center for Scientific Place: Embassy Suites at the Chevy Chase and Integrative Diabetes and Obesity Study Review Special Emphasis Panel; Pavilion, 4300 Military Road NW, Section. Fellowships: Biophysical, Physiological, Washington, DC 20015. Date: October 18–19, 2018. Pharmacological and Bioengineering Contact Person: Lawrence Ka-Yun Ng, Time: 8:00 a.m. to 5:00 p.m. Neuroscience. Ph.D., Scientific Review Officer, Center for Agenda: To review and evaluate grant Date: October 18–19, 2018. Scientific Review, National Institutes of applications. Time: 8:00 a.m. to 5:00 p.m. Health, 6701 Rockledge Drive, Room 6152, Place: Embassy Suites at the Chevy Chase Agenda: To review and evaluate grant MSC 7804, Bethesda, MD 20892, 301–357– Pavilion, 4300 Military Road NW, applications. 9318, [email protected]. Washington, DC 20015. Contact Person: Hui Chen, MD, Scientific Place: Doubletree Hotel Bethesda, Name of Committee: Molecular, Cellular Review Officer, Center for Scientific Review, (Formerly Holiday Inn Select), 8120 and Developmental Neuroscience Integrated National Institutes of Health, 6701 Rockledge Wisconsin Avenue, Bethesda, MD 20814. Review Group; Drug Discovery for the Drive, Bethesda, MD 20892, 301–435–1044, Contact Person: Sussan Paydar, Ph.D., Nervous System Study Section. [email protected]. Scientific Review Officer, Center for Date: October 18–19, 2018. Scientific Review, National Institutes of Time: 8:00 a.m. to 4:00 p.m. Name of Committee: Population Sciences Health, 6701 Rockledge Drive, RM 5222, Agenda: To review and evaluate grant and Epidemiology Integrated Review Group; Bethesda, MD 20817, (301) 827–4994, applications. Social Sciences and Population Studies B [email protected]. Place: Embassy Suites Alexandria Old Study Section. Date: October 18, 2018. Name of Committee: Brain Disorders and Town, 1900 Digonal Road, Alexandria, VA Time: 8:30 a.m. to 6:30 p.m. Clinical Neuroscience Integrated Review 22314. Agenda: To review and evaluate grant Group; Developmental Brain Disorders Study Contact Person: Mary Custer, Ph.D., Scientific Review Officer, Center for applications. Section. Place: Marriott Wardman Park Washington Date: October 18–19, 2018. Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 4148, DC Hotel, 2660 Woodley Road NW, Time: 8:00 a.m. to 5:00 p.m. Washington, DC 20008. Agenda: To review and evaluate grant MSC 7850, Bethesda, MD 20892, (301) 435– 1164, [email protected]. Contact Person: Kate Fothergill, Ph.D., applications. Scientific Review Officer, Center for Place: Beacon Hotel and Corporate Name of Committee: Immunology Scientific Review, National Institutes of Quarters, 1615 Rhode Island Avenue NW, Integrated Review Group; Immunity and Host Health, 6701 Rockledge Drive, Room 3142, Washington, DC 20036. Defense Study Section. Bethesda, MD 20892, 301–435–2309, Contact Person: Pat Manos, Ph.D., Date: October 18–19, 2018. [email protected]. Scientific Review Officer, Center for Time: 8:00 a.m. to 5:00 p.m. Name of Committee: Center for Scientific Scientific Review, National Institutes of Agenda: To review and evaluate grant Review Special Emphasis Panel; Member Health, 6701 Rockledge Drive, Room 5200, applications. Conflict: Topics in Infectious Diseases. MSC 7846, Bethesda, MD 20892, 301–408– Place: The William F. Bolger Center, 9600 Date: October 18, 2018. 9866, [email protected]. Newbridge Drive, Potomac, MD 20854. Time: 3:00 p.m. to 5:00 p.m. Contact Person: Scott Jakes, Ph.D., Name of Committee: Integrative, Agenda: To review and evaluate grant Scientific Review Officer, Center for Functional and Cognitive Neuroscience applications. Scientific Review, National Institutes of Integrated Review Group; Somatosensory and Place: National Institutes of Health, 6701 Health, 6701 Rockledge Drive, Room 4198, Pain Systems Study Section. Rockledge Drive, Bethesda, MD 20892 MSC 7812, Bethesda, MD 20892, 301–435– Date: October 18–19, 2018. (Telephone Conference Call). Time: 8:00 a.m. to 5:00 p.m. 1506, [email protected]. Contact Person: Neerja Kaushik-Basu, Agenda: To review and evaluate grant Name of Committee: Digestive, Kidney and Ph.D., Scientific Review Officer, Center for applications. Urological Systems Integrated Review Group; Scientific Review, National Institutes of Place: Holiday Inn Hotel & Suites, 625 First Systemic Injury by Environmental Exposure. Health, 6701 Rockledge Drive, Room 3198, Street, Alexandria, VA 22314. Date: October 18–19, 2018. MSC 7808, Bethesda, MD 20892, (301) 435– Contact Person: M. Catherine Bennett, Time: 8:00 a.m. to 5:00 p.m. 2306, [email protected]. Ph.D., Scientific Review Officer, Center for Agenda: To review and evaluate grant Name of Committee: Integrative, Scientific Review, National Institutes of applications. Functional and Cognitive Neuroscience Health, 6701 Rockledge Drive, Room 5182, Place: Mayflower Park Hotel, 405 Olive Integrated Review Group; Chemosensory MSC 7846, Bethesda, MD 20892, 301–435– Way, Seattle, WA 98101. Systems Study Section. 1766, [email protected]. Contact Person: Meenakshisundar Date: October 19, 2018. Name of Committee: Cell Biology Ananthanarayanan, Ph.D., Scientific Review Time: 8:00 a.m. to 6:00 p.m. Integrated Review Group; Cellular Officer, Center for Scientific Review, Agenda: To review and evaluate grant Mechanisms in Aging and Development National Institutes of Health, 6701 Rockledge applications. Study Section. Drive, Room 4200, Bethesda, MD 20817, 301– Place: Washington Plaza Hotel, 10 Thomas Date: October 18–19, 2018. 435–1234, ananth.ananthanarayanan@ Circle NW, Washington, DC 20005. Time: 8:00 a.m. to 5:00 p.m. nih.gov. Contact Person: John Bishop, Ph.D., Agenda: To review and evaluate grant Name of Committee: Cardiovascular and Scientific Review Officer, Center for applications. Respiratory Sciences Integrated Review Scientific Review, National Institutes of Place: Hyatt Regency Bethesda, One Group; Clinical and Integrative Health, 6701 Rockledge Drive, Room 5182, Bethesda Metro Center, 7400 Wisconsin Cardiovascular Sciences Study Section. MSC 7844, Bethesda, MD 20892, (301) 408– Avenue, Bethesda, MD 20814. Date: October 18–19, 2018. 9664, [email protected].

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Name of Committee: Center for Scientific ACTION: 30-Day notice. (3) Enhance the quality, utility, and Review Special Emphasis Panel; Academic clarity of the information to be Research Enhancement Award. SUMMARY: This notice announces that collected; and Date: October 19, 2018. the Transportation Security Time: 1:00 p.m. to 5:00 p.m. (4) Minimize the burden of the Agenda: To review and evaluate grant Administration (TSA) has forwarded the collection of information on those who applications. Information Collection Request (ICR), are to respond, including using Place: National Institutes of Health, 6701 Office of Management and Budget appropriate automated, electronic, Rockledge Drive, Bethesda, MD 20892. (OMB) control number 1652–0039, mechanical, or other technological Contact Person: Inna Gorshkova, Ph.D., abstracted below to OMB for review and collection techniques or other forms of Scientific Review Officer, Center for approval of a revision of the currently information technology. Scientific Review, National Institutes of approved collection under the Health, 6701 Rockledge Drive, Bethesda, MD Paperwork Reduction Act (PRA). The Consistent with the requirements of 20892, 301–435–1784, [email protected]. ICR describes the nature of the Executive Order (E.O.) 13771, Reducing (Catalogue of Federal Domestic Assistance information collection and its expected Regulation and Controlling Regulatory Program Nos. 93.306, Comparative Medicine; burden. The collection involves the Costs, and E.O.13777, Enforcing the 93.333, Clinical Research, 93.306, 93.333, Regulatory Reform Agenda, TSA is also 93.337, 93.393–93.396, 93.837–93.844, submission of information from claimants to examine and resolve tort requesting comments on the extent to 93.846–93.878, 93.892, 93.893, National which this request for information could Institutes of Health, HHS) claims against the agency. be modified to reduce the burden on Dated: September 14, 2018. DATES: Send your comments by October respondents. Sylvia L. Neal, 22, 2018. A comment to OMB is most Program Analyst, Office of Federal Advisory effective if OMB receives it within 30 Information Collection Requirement Committee Policy. days of publication. Title: TSA Claims Application. [FR Doc. 2018–20416 Filed 9–19–18; 8:45 am] ADDRESSES: Interested persons are Type of Request: Revision of a BILLING CODE 4140–01–P invited to submit written comments on currently approved collection. the proposed information collection to the Office of Information and Regulatory OMB Control Number: 1652–0039. DEPARTMENT OF HEALTH AND Affairs, OMB. Comments should be Forms(s): Supplemental Information HUMAN SERVICES addressed to Desk Officer, Department Form, Payment Form. National Institutes of Health of Homeland Security/TSA, and sent via Affected Public: Members of the electronic mail to dhsdeskofficer@ traveling public who believe they have National Center for Complementary & omb.eop.gov. experienced property loss or damage, a personal injury, or other damages due to Integrative Health; Amended Notice of FOR FURTHER INFORMATION CONTACT: the negligent or wrongful act or Meeting Christina A. Walsh, TSA PRA Officer, omission of a TSA employee within Information Technology (IT), TSA–11, Notice is hereby given of a change in their scope of employment, and decide Transportation Security Administration, the meeting of the National Advisory to seek compensation by filing a federal 601 South 12th Street, Arlington, VA Council for Complementary and tort claim against TSA. Integrative Health, October 5, 2018, 8:30 20598–6011; telephone (571) 227–2062; a.m. to October 5, 2018, 04:00 p.m., email [email protected]. Abstract: The TSA Claims, Outreach, National Institutes of Health, Building and Debt Branch adjudicates tort claims SUPPLEMENTARY INFORMATION: TSA pursuant to the Federal Tort Claims Act 31, 31 Center Drive, Conference Room published a Federal Register notice, 10, Bethesda, MD 20892 which was (28 U.S.C. 1346(b), 1402(b), 2401(b), with a 60-day comment period soliciting 2671–2680). OMB Control Number published in the Federal Register on comments, of the following collection of August 28, 2018, 83 FR167, page 43883. 1652–0039, TSA Claims Application, information on May 10, 2018, at 83 FR allows the agency to collect information This meeting notice is amended to 21788. change the starting time of the OPEN from claimants to examine and resolve SESSION from 10:00 a.m. to 9:30 a.m. Comments Invited tort claims against the agency. (EDT). The meeting is partially Closed In accordance with the Paperwork The claims branch has changed its to the public. Reduction Act of 1995 (44 U.S.C. 3501 name from Claims Management Branch Dated: September 17, 2018. et seq.), an agency may not conduct or to Claims, Outreach, and Debt Branch and is revising the information Ronald J. Livingston, Jr., sponsor, and a person is not required to collection form by changing the name Program Analyst, Office of Federal Advisory respond to, a collection of information from ‘‘TSA Claims Management Branch Committee Policy. unless it displays a valid OMB control number. The ICR documentation will be Program’’ to ‘‘TSA Claims Application.’’ [FR Doc. 2018–20483 Filed 9–19–18; 8:45 am] These changes provide the public with BILLING CODE 4140–01–P available at http://www.reginfo.gov upon its submission to OMB. Therefore, a better understanding of the in preparation for OMB review and operational functions conducted when a approval of the following information member of the traveling public files an DEPARTMENT OF HOMELAND SF–95, claims application. SECURITY collection, TSA is soliciting comments to— TSA receives approximately 850 tort Transportation Security Administration (1) Evaluate whether the proposed claims per month arising from airport information requirement is necessary for screening activities, motor vehicle Revision of Agency Information the proper performance of the functions accidents, and employee loss, among Collection Activity Under OMB Review: of the agency, including whether the others. TSA Claims Application information will have practical utility; Number of Respondents: 10,200. AGENCY: Transportation Security (2) Evaluate the accuracy of the Estimated Annual Burden Hours: An Administration, DHS. agency’s estimate of the burden; estimated 5,300 hours.

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Dated: September 14, 2018. also be directed to robert.manford@ City of Los Angeles Department of Christina A. Walsh, lacity.org, Fax: (213) 808–8914, (NEPA) Building and Safety; (3) Public Benefits TSA Paperwork Reduction Act Officer, and Dhiraj Narayan, Development Project and Alternative Compliance Information Technology. Officer, Development Services, HACLA, approval from the Los Angeles [FR Doc. 2018–20412 Filed 9–19–18; 8:45 am] [email protected], telephone Department of City Planning; (4) BILLING CODE 9110–05–P number 213–252–6120, fax number National Environmental Policy Act 213–252–2739 (CEQA). (NEPA) Part 58 Compliance necessary Public Participation: The public will for Demolition/Disposition and Rental DEPARTMENT OF HOUSING AND be invited to participate in the review of Assistance Demonstration (RAD) URBAN DEVELOPMENT the Draft EIR/EIS. Release of the Draft Conversion of the existing Rose Hill EIR/EIS will be announced through Courts development to Section 8 Project [Docket No. FR–6126–N–01] public mailings as well as the local Based Vouchers from the United States news media. All interested Federal, Department of Housing and Urban Notice of Intent To Prepare a Draft state, and local agencies, Indian tribes, Development (HUD); (5) Certification of Environmental Impact Statement for groups, and the public are invited to the Environmental Impact Report/ the Rose Hill Courts Redevelopment comment on the scope of the EIR/EIS. If Environmental Impact Statement; (6) AGENCY: Office of the Assistant you are an agency with jurisdiction by Haul route approval from the Los Secretary for Community Planning and law over natural or other public Angeles Department of Building and Development, HUD. resources affected by the project, HCID Safety (if required); (7) Permit for needs to know what environmental removal of street trees from the Los ACTION: Notice of Intent (NOI) to prepare information germane to your statutory an Environmental Impact Statement Angeles Board of Public Works (if responsibilities should be included in (EIS). required); and (8) Other discretionary the EIR/EIS. and ministerial permits and approvals SUMMARY: The City of Los Angeles, SUPPLEMENTARY INFORMATION: that may be deemed necessary, including, but not limited to, temporary through the Housing and Community Project Name and Description Development Investment Department street closure permits, grading permits, (HCID), is providing notice of its intent HCID will consider a proposal to excavation permits, foundation permits, to prepare a combined Environmental redevelop the project site including new building permits, and sign permits in Impact Statement (EIS) in accordance construction of 191 new affordable order to execute and implement the with the National Environmental Policy housing units, developed in two phases. Project. Act (NEPA) and Environmental Impact Proposed improvements include 176 This is to be a combined Report (EIR) in accordance with the parking spaces, a new property environmental document, an EIR, California Environmental Quality Act management and maintenance office, prepared under the State of California (CEQA) (EIR/EIS) for the Rose Hill and new landscaping. The project site is CEQA (Public Resources Code 21000 et Courts Redevelopment Project located 5.24-acres in size and is located at 4446 seq. and 14 California Code of in Los Angeles, CA. The proposed Florizel Street in Los Angeles, Regulations 15000 et seq.), and an EIS, California. The site slopes in a west to prepared under NEPA (42 U.S.C. 4321) action is subject to compliance with ¥ NEPA because the Housing Authority of east direction by +/ 65 feet, and it is and implementing regulations of the the City of the City of Los Angeles currently developed with a total of 15 Council on Environmental Quality (40 (HACLA) is proposing a HUD Section 18 buildings, comprised of 14 residential CFR parts 1500–1508) and HUD (24 CFR demolition/disposition and the buildings with 100-multi-family units, part 58). The Project involves funding from developer is planning to use Project and one administration building (i.e., HUD that qualifies as an ‘‘undertaking’’ Based Section 8 vouchers. HACLA will offices and a common room with a subject to the Programmatic Agreement consider a Disposition and Development kitchen, pantry, and two bathrooms). The project site is bounded by (PA) Among the City of Los Angeles, the Agreement. This Notice of Intent to Florizel Street to the north; McKenzie California State Historic Preservation prepare an EIS represents the beginning Avenue to the east; Mercury Avenue to Officer, and the Advisory Council on of the public scoping process. Following the south; and Boundary Avenue to the Historic Preservation Regarding Historic the scoping meeting referenced below, a west. An onsite driveway, Victorine Properties Affected by use of Draft EIS will be prepared and Street, runs in an east-west direction Community Development Block Grants; ultimately circulated. across the middle of the project McKinney Act Homeless Programs ADDRESSES: Comments relating to the bisecting the site into two parts: The including the Emergency Shelter Grants scope of the EIR/EIS are requested and northern part and the southern part. Program, Transitional Housing, will be accepted by the contact persons Land uses surrounding the project site Permanent Housing for the Homeless listed below until October 20, 2018. Any include the Ernest E. Debs Regional Park Handicapped, and Supplemental person or agency interested in receiving to the west, along Mercury Avenue and Assistance for Facilities to Assist the a notice and wishing to comment on the Boundary Avenue; Rose Hill Park to the Homeless; Home Investment draft EIR/EIS should contact the persons north; the Rose Hill Recreation Center to Partnership Funds, and the Shelter Plus listed below. Documents are available at the southeast. Our Lady of Guadalupe Care Program for compliance with 36 the following website: http:// Catholic Church and Elementary School CFR part 800, the regulations hcidla.lacity.org/NEPA-review. is located east of the project site, along implementing Section 106 of the FOR FURTHER INFORMATION CONTACT: Dr. Browne Avenue. Single-family and National Historic Preservation Act. Robert Manford, Environmental Affairs multi-family residential developments HCID will be initiating the Section 106 Officer, Planning and Land Use, Finance are located to the south and east. consultation process with the SHPO & Development Division of the City of The project would require the through the PA. Los Angeles Housing, Community following discretionary approvals: (1) The project proposes the demolition Investment Department, 1200 West 7th Disposition and Development of all 15 buildings at Rose Hill Courts Street, 8th Floor, Los Angeles, CA Agreement approval from HACLA; (2) and subsequent construction of 191 90017. Comments and questions can Grading and Building Permits from the affordable public housing units. Rose

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Hill Courts was constructed in 1942 by Probable Environmental Effects Dated: September 14, 2018. HACLA as a low-income public housing Neal J. Rackleff, project. Rose Hill Courts was The following subject areas will be Assistant Secretary. analyzed in the combined EIR/EIS for determined eligible for listing in the [FR Doc. 2018–20514 Filed 9–17–18; 4:15 pm] probable environmental effects: National Register of Historic Places. The BILLING CODE 4210–67–P Rose Hill Courts complex is located at Aesthetics, Air Quality, Biological 4446 Florizel Street, on a 5.24-acre site. Resources, Cultural Resources, Geology The site is located within the Northeast and Soils, Greenhouse Gas Emissions, DEPARTMENT OF THE INTERIOR Los Angeles Community Plan, in the Hazards and Hazardous Materials, Land Rose Hills neighborhood area of the City Use and Planning, Noise, Population Bureau of Land Management of Los Angeles. and Housing, Public Services, [LLES930000.L51040000.FI0000. 18X] Alternatives to the Proposed Action Recreation, Transportation/Traffic, and Tribal Cultural Resources. Notice of Proposed Reinstatement of The EIR/EIS will discuss the Terminated Oil and Gas Leases in Ohio alternatives that were considered for Scoping Meeting analysis, identify those that were AGENCY: A public scoping meeting will be held Bureau of Land Management, eliminated from further consideration Interior. from 5:00 p.m. to 7:00 p.m. on October because they do not meet the stated 4, 2018, at the Rose Hill Courts ACTION: Notice of reinstatement. purpose and need, and identify those that will be analyzed further. It is Community Center at 4446 Florizel SUMMARY: As provided for under the expected that project alternatives will Street, Los Angeles, California. The Mineral Leasing Act of 1920, as continue to be developed and refined scoping process also includes the amended, the Bureau of Land during the public scoping process, with initiation of the NHPA Section 106 Management (BLM) received a petition input from the public, agencies, and consultation process. We invite for reinstatement of competitive oil and other stakeholders. The EIR/EIS comments from all interested parties gas leases OHES058186, OHES058187, alternatives analysis will consist of a about the potential impacts this project OHES058188, OHES058191, comparison of the impacts under each may have on historic properties, OHES058198, OHES058199, alternative pursuant to 24 CFR part 58, cultural resources, or biological and OHES058200, OHES058203, in addition to how well each alternative natural resources as well as the impacts OHES058204, OHES058205, and achieves the project’s purpose and need. these resources may have on the project. OHES058213 from Eclipse Resources I, This process, which will be described in We invite all interested parties to LP for land in Monroe County, Ohio. detail in the EIR/EIS, will lead to the participate in the scoping meeting. The lessee filed the petition on time, designation of a Preferred Alternative. along with all rentals due since the At this time, it is anticipated that the Lead Agencies leases terminated under the law. No leases affecting these lands were issued following alternatives will be analyzed: HCID is the responsible entity (RE) before the petition was filed. The BLM (1) No Project/No Action Alternative; (2) and lead agency for this project in proposes to reinstate the leases. Non-Historically Compliant accordance with 24 CFR part 58, Rehabilitation Alternative; and (3) ‘‘Environmental Review Procedures for FOR FURTHER INFORMATION CONTACT: Historic Rehabilitation. Entities Assuming HUD Environmental Kathy Gunderman, Branch Chief for Fluid Minerals Adjudication, Bureau of 1. No Project/No Action Alternative. Responsibilities.’’ As a RE, the HCID This alternative would be the Land Management, Eastern States State assumes the responsibility for continuation of uses on the site; Office, 20 M Street SE, Suite 950, environmental review, decision-making, therefore, existing buildings and tenants Washington, DC 20003; phone 202–912– would remain at the project site and no and action that would otherwise apply 7721; email [email protected]. buildings or uses would be constructed to HUD under NEPA. Section 26 of the Persons who use a or demolished. United States Housing Act (42 U.S.C. telecommunications device for the deaf 2. Non-Historically Compliant 1437x) allows units of general local may call the Federal Relay Service (FRS) Rehabilitation Alternative. This government to assume NEPA at 1–800–877–8339 to contact Kathy alternative would redevelop the existing responsibilities in projects involving Gunderman during normal business units at Rose Hill Courts but not in a Section 18 demolition/disposition and hours. The FRS is available 24 hours a way that would preserve their historic Section 8 Project-Based Vouchers. The day, 7 days a week, to leave a message integrity. However, the Non-Historically project may use CDBG and HOME or question with the above individual. Compliant Rehabilitation Alternative funds. If so, Section 104(g) of the A reply will be sent during normal would retain the existing 100 units on Housing and Community Development business hours. the project site and would not allow for Act of 1974 (42 U.S.C. 5304(g)) and SUPPLEMENTARY INFORMATION: The lessee the opportunity to increase the number Section 288 of the HOME Investment agreed to the amended lease terms for of affordable housing units on the Partnerships Act (42 U.S.C. 12838) rentals and royalties at rates of $10 per project site. allow CDBG recipients and HOME acre, or fraction thereof, per year and 3. Historic Rehabilitation. This jurisdictions, respectively, to assume 162⁄3 percent, respectively. The lessee alternative would redevelop the existing NEPA responsibilities for CDBG and has paid the required $500 units at Rose Hill Courts in a way that HOME projects. administrative fee and the $159 cost of would preserve the historic integrity of publishing this notice for each lease. In addition, the HACLA is the CEQA the buildings. This alternative would The lessee met the requirements for lead agency and is responsible for restore the characteristics of the Garden reinstatement of the leases per Sec. preparing an EIR. Questions may be Style design utilized in the Rose Hill 31(d) and (e) of the Mineral Leasing Act Courts development, including but not directed to the individuals named in of 1920 (30 U.S.C. 188). The BLM limited to low-slung buildings, large this notice under the heading FOR proposes to reinstate the leases effective open spaces, and recreational amenities. FURTHER INFORMATION CONTACT. February 1, 2018, under the original

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terms and conditions of the leases, and administrative fee and the $159 cost of Background the increased rental and royalty rates publishing this notice. The lessee agreed cited above. to additional lease stipulations on lease The Commission instituted this investigation effective October 5, 2017, Authority: 30 U.S.C. 188 (e)(4) and 43 CFR WYW–177798 to protect nesting raptors, 3108.2–3(b)(2)(v). Greater Sage-Grouse habitat, amphibian following receipt of a petition filed with and reptile species habitat, and to the Commission and Commerce by Mitchell Leverette, protect the historic and visual values of Bonney Forge Corporation, Mount Acting State Director, Eastern States. the Lincoln Highway/Union Pacific Union, Pennsylvania, and the United [FR Doc. 2018–20504 Filed 9–19–18; 8:45 am] Railroad Grade historic property. The Steel, Paper and Forestry, Rubber, BILLING CODE 4310–GJ–P lessee agreed to additional lease Manufacturing, Energy, Allied stipulations on leases WYW–183048, Industrial and Service Workers WYW–183807, and WYW–185588 to International Union, Pittsburgh, DEPARTMENT OF THE INTERIOR protect Greater Sage-Grouse habitat. The Pennsylvania. The Commission lessee agreed to additional lease Bureau of Land Management established a general schedule for the stipulations on lease WYW–183830 to final phase of its investigations on [LLWY920000.L51040000.FI0000. protect raptor nesting habitat. The lessee forged steel fittings from China, India, 18XL5017AR] agreed to the removal of a lease and Taiwan 3 following notifications of stipulation to protect Greater Sage- Notice of Proposed Reinstatement of preliminary determinations by Grouse habitat on lease WYW185283 Commerce that imports of forged steel Terminated Oil and Gas Leases in because the lease is no longer within 2 Wyoming (Southland 17) fittings from China, Italy, and Taiwan miles of a lek managed as occupied. No were being sold at LTFV within the additional stipulations were added to AGENCY: Bureau of Land Management, meaning of section 733(b) of the Act (19 the other leases. Interior. U.S.C. 1673b(b)).4 Notice of the The lessee met the requirements for ACTION: Notice. scheduling of the final phase of the reinstatement of the leases per Sec. Commission’s investigation and of a SUMMARY: As provided for under the 31(d) and (e) of the Mineral Leasing Act Mineral Leasing Act of 1920, as of 1920 (30 U.S.C. 188). The BLM public hearing to be held in connection amended, the Bureau of Land proposes to reinstate each of the leases therewith was given by posting copies Management (BLM) received petitions effective on the date of termination, of the notice in the Office of the for reinstatement of competitive oil and under amended terms and conditions Secretary, U.S. International Trade gas leases WYW–177798, WYW– including the increased rental and Commission, Washington, DC, and by 183048, WYW–183798, WYW- 183807, royalty rates cited above. publishing the notice in the Federal Register of June 4, 2018, (83 FR 25715, WYW–183830, WYW–185283, WYW– Authority: 30 U.S.C. 188(e)(4) and 43 CFR 185588, WYW–185589, WYW–185591, 3108.2–3(b)(2)(v). June 4, 2018). The hearing was held in WYW–185593, WYW–185594, WYW– Washington, DC, on August 2, 2018, and 185595, WYW–185596, WYW–185597, Chris Hite, all persons who requested the WYW–185598, WYW–185599, and Chief, Branch of Fluid Minerals Adjudication. opportunity were permitted to appear in WYW–185601 from Southland Royalty [FR Doc. 2018–20501 Filed 9–19–18; 8:45 am] person or by counsel. Company LLC for land in Carbon and BILLING CODE 4310–22–P The Commission made this Sweetwater Counties, Wyoming. The determination pursuant to section lessee filed the petitions on time, along 735(b) of the Act (19 U.S.C. 1673d(b)). with all rentals due since the leases INTERNATIONAL TRADE It completed and filed its determination terminated under the law. No new in this investigation on September 14, leases affecting these lands were issued COMMISSION 2018. The views of the Commission are before the petitions were filed. The BLM contained in USITC Publication 4823 proposes to reinstate the leases. [Investigation No. 731–TA–1396 (Final)] (September 2018), entitled Forged Steel FOR FURTHER INFORMATION CONTACT: Fittings from Taiwan: Investigation No. Chris Hite, Branch Chief for Fluid Forged Steel Fittings From Taiwan 731–TA–1396 (Final). Minerals Adjudication, Bureau of Land Determination Management, Wyoming State Office, By order of the Commission. 5353 Yellowstone Road, P.O. Box 1828, On the basis of the record 1 developed Cheyenne, Wyoming, 82003; phone in the subject investigation, the United 3 Forged Steel Fittings From China, India, and 307–775–6176; email [email protected]. States International Trade Commission Taiwan: Scheduling of the Final Phase of Persons who use a (‘‘Commission’’) determines, pursuant Countervailing Duty and Antidumping Duty Investigations, 83 FR 25715, June 4, 2018. telecommunications device for the deaf to the Tariff Act of 1930 (‘‘the Act’’), 4 Forged Steel Fittings From the People’s Republic may call the Federal Relay Service (FRS) that an industry in the United States is of China: Affirmative Preliminary Determination of at 1–800–877–8339 to contact Mr. Hite materially injured by reason of imports Sales at Less Than Fair Value, Postponement of during normal business hours. The FRS of forged steel fittings from Taiwan that Final Determination and Extension of Provisional Measures, 83 FR 22948, May 17, 2018; Forged Steel is available 24 hours a day, 7 days a have been found by the U.S. Department Fittings From Italy: Preliminary Affirmative week, to leave a message or question of Commerce (‘‘Commerce’’) to be sold Determination of Sales at Less Than Fair Value, with the above individual. A reply will in the United States at less than fair Postponement of Final Determination and be sent during normal business hours. value (‘‘LTFV’’).2 Extension of Provisional Measures, 83 FR 22954, May 17, 2018; and Forged Steel Fittings From SUPPLEMENTARY INFORMATION: The lessee Taiwan: Affirmative Preliminary Determination of agreed to the amended lease terms for 1 The record is defined in sec. 207.2(f) of the Sales at Less Than Fair Value, 83 FR 22957, May rentals and royalties at rates of $10 per Commission’s Rules of Practice and Procedure (19 17, 2018; see also Forged Steel Fittings From the CFR 207.2(f)). People’s Republic of China: Preliminary Affirmative acre, or fraction thereof, per year and 2 Forged Steel Fittings From Taiwan: Final Countervailing Duty Determination and Alignment 2 16 ⁄3 percent, respectively. The lessee Determination of Sales at Less Than Fair Value, 83 of Final Determination With Final Antidumping has paid the required $500 FR 36519, July 30, 2018. Duty Determination, 83 FR 11170, March 14, 2018.

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Issued: September 14, 2018. of U.S. Patent No. 7,162,537 (‘‘the ’537 INTERNATIONAL TRADE Lisa Barton, patent’’); U.S. Patent No. 8,356,296 (‘‘the COMMISSION Secretary to the Commission. ’296 patent’’); U.S. Patent No. 7,290,164 [FR Doc. 2018–20441 Filed 9–19–18; 8:45 am] (‘‘the ’164 patent’’); U.S. Patent No. Notice of Receipt of Complaint; Solicitation of Comments Relating to BILLING CODE 7020–02–P 7,340,597 (‘‘the ’597 patent’’); U.S. Patent No. 6,741,592 (‘‘the ’592 patent’’); the Public Interest and U.S. Patent No. 7,200,145 (‘‘the ’145 AGENCY: U.S. International Trade INTERNATIONAL TRADE patent’’), and alleges that an industry in Commission. the United States exists as required by COMMISSION ACTION: Notice. subsection (a)(2) of section 337. The [Investigation No. 337–TA–944 ’296 patent was withdrawn from the (Enforcement Proceeding)] SUMMARY: Notice is hereby given that investigation. The notice of the U.S. International Trade Certain Network Devices, Related investigation named Arista Networks, Commission has received a complaint Software and Components Thereof (I): Inc. (‘‘Arista’’) of Santa Clara, California entitled Certain LTE- and 3G-Compliant Commission Decision To Terminate as the respondent. A Commission Cellular Communications Devices, DN the Enforcement Proceeding Based on investigative attorney participated in the 3342; the Commission is soliciting Settlement investigation. comments on any public interest issues On June 23, 2016, the Commission raised by the complaint or AGENCY: U.S. International Trade found that a Section 337 violation had complainant’s filing pursuant to the Commission. occurred as to the ’537, ’592, and ’145 Commission’s Rules of Practice and ACTION: Notice. patents and therefore issued a limited Procedure. exclusion order and a cease and desist FOR FURTHER INFORMATION CONTACT: Lisa SUMMARY: Notice is hereby given that order (‘‘CDO’’) against Arista. 81 FR R. Barton, Secretary to the Commission, the U.S. International Trade 42375–76 (June 29, 2016). U.S. International Trade Commission, Commission has determined to grant the 500 E Street SW, Washington, DC private parties’ joint motion to terminate On August 26, 2016, Cisco filed an 20436, telephone (202) 205–2000. The the enforcement proceeding based on enforcement complaint alleging that public version of the complaint can be settlement. The enforcement proceeding Arista had violated the June 23, 2016 accessed on the Commission’s is terminated. CDO by reason of infringement of the ’537 patent. The Commission instituted Electronic Document Information FOR FURTHER INFORMATION CONTACT: this enforcement proceeding on October System (EDIS) at https://edis.usitc.gov, Amanda Pitcher Fisherow, Esq., Office and will be available for inspection of the General Counsel, U.S. 4, 2016, based on Cisco’s complaint. 81 FR 68455 (Oct. 4, 2016). during official business hours (8:45 a.m. International Trade Commission, 500 E to 5:15 p.m.) in the Office of the Street SW, Washington, DC 20436, On August 24, 2018, Cisco and Arista Secretary, U.S. International Trade telephone (202) 205–2737. Copies of filed a joint motion to terminate the Commission, 500 E Street SW, non-confidential documents filed in enforcement proceeding based on Washington, DC 20436, telephone (202) connection with this investigation are or settlement. The motion includes both 205–2000. will be available for inspection during confidential and public versions of a General information concerning the official business hours (8:45 a.m. to 5:15 binding term sheet, and the parties Commission may also be obtained by p.m.) in the Office of the Secretary, U.S. represent that there are no other accessing its internet server at United International Trade Commission, 500 E agreements, written or oral, express or States International Trade Commission Street SW, Washington, DC 20436, implied between them concerning the (USITC) at https://www.usitc.gov. The telephone (202) 205–2000. General subject matter of the proceeding. The public record for this investigation may information concerning the Commission parties also contend that the termination be viewed on the Commission’s may also be obtained by accessing its of the investigation would not adversely Electronic Document Information internet server at http://www.usitc.gov. affect the public interest. System (EDIS) at https://edis.usitc.gov. The public record for this investigation The Commission has determined to Hearing-impaired persons are advised may be viewed on the Commission’s grant the joint motion. The Commission that information on this matter can be electronic docket (EDIS) at http:// finds that the private parties have obtained by contacting the edis.usitc.gov. Hearing-impaired complied with the Commission’s Rules, Commission’s TDD terminal on (202) persons are advised that information on and that termination of the enforcement 205–1810. this matter can be obtained by proceeding would not adversely affect SUPPLEMENTARY INFORMATION: The contacting the Commission’s TDD the public interest. The proceeding is Commission has received a complaint terminal on (202) 205–1810. terminated. and a submission pursuant to § 210.8(b) SUPPLEMENTARY INFORMATION: The The authority for the Commission’s of the Commission’s Rules of Practice Commission instituted the underlying determination is contained in section and Procedure filed on behalf of INVT investigation on January 27, 2015, based 337 of the Tariff Act of 1930, as SPE LLC on September 14, 2018. The on a complaint filed on behalf of Cisco amended, 19 U.S.C. 1337, and in Part complaint alleges violations of section Systems, Inc. (‘‘Cisco’’) of San Jose, 210 of the Commission’s Rules of 337 of the Tariff Act of 1930 (19 U.S.C. California. 80 FR 4314–15 (Jan. 27, Practice and Procedure, 19 CFR part 1337) in the importation into the United 2015). The complaint alleges violations 210. States, the sale for importation, and the of section 337 based upon the sale within the United States after By order of the Commission. importation into the United States, the importation of certain LTE- and 3G- sale for importation, and the sale within Issued: September 17, 2018. compliant cellular communications the United States after importation of Lisa Barton, devices. The complaint names as certain network devices, related Secretary to the Commission. respondents: Apple Inc. of Cupertino, software and components thereof by [FR Doc. 2018–20473 Filed 9–19–18; 8:45 am] CA; HTC Corporation of China; HTC reason of infringement of certain claims BILLING CODE 7020–02–P America, Inc. of Seattle, Washington;

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ZTE Corporation of China; and ZTE under § 210.8(c)(2) of the Commission’s of 1930, as amended (19 U.S.C. 1337), (USA) Inc. of Richardson, TX. The Rules of Practice and Procedure (19 CFR and of §§ 201.10 and 210.8(c) of the complainant requests that the 210.8(c)(2)). Commission’s Rules of Practice and Commission issue a limited exclusion Persons filing written submissions Procedure (19 CFR 201.10, 210.8(c)). order, cease and desist order or orders, must file the original document By order of the Commission. and impose a bond during the 60-day electronically on or before the deadlines Issued: September 14, 2018. review period pursuant to 19 U.S.C. stated above and submit 8 true paper 1337(j). copies to the Office of the Secretary by Lisa Barton, Proposed respondents, other noon the next day pursuant to § 210.4(f) Secretary to the Commission. interested parties, and members of the of the Commission’s Rules of Practice [FR Doc. 2018–20429 Filed 9–19–18; 8:45 am] public are invited to file comments, not and Procedure (19 CFR 210.4(f)). BILLING CODE 7020–02–P to exceed five (5) pages in length, Submissions should refer to the docket inclusive of attachments, on any public number (‘‘Docket No. 3342’’) in a interest issues raised by the complaint prominent place on the cover page and/ DEPARTMENT OF JUSTICE or § 210.8(b) filing. Comments should or the first page. (See Handbook for address whether issuance of the relief Electonic Filing Procedures, Electronic Antitrust Division specifically requested by the Filing Procedures 1). Persons with complainant in this investigation would questions regarding filing should Notice Pursuant to the National affect the public health and welfare in contact the Secretary (202–205–2000). Cooperative Research and Production the United States, competitive Any person desiring to submit a Act of 1993—Advanced Media conditions in the United States document to the Commission in Workflow Association, Inc. economy, the production of like or confidence must request confidential treatment. All such requests should be Notice is hereby given that, on directly competitive articles in the September 10, 2018, pursuant to Section United States, or United States directed to the Secretary to the Commission and must include a full 6(a) of the National Cooperative consumers. Research and Production Act of 1993, In particular, the Commission is statement of the reasons why the 15 U.S.C. 4301 et seq. (‘‘the Act’’), interested in comments that: Commission should grant such (i) Explain how the articles treatment. See 19 CFR 201.6. Documents Advanced Media Workflow Association, potentially subject to the requested for which confidential treatment by the Inc. has filed written notifications remedial orders are used in the United Commission is properly sought will be simultaneously with the Attorney States; treated accordingly. All such requests General and the Federal Trade (ii) identify any public health, safety, should be directed to the Secretary to Commission disclosing changes in its or welfare concerns in the United States the Commission and must include a full membership. The notifications were relating to the requested remedial statement of the reasons why the filed for the purpose of extending the orders; Commission should grant such Act’s provisions limiting the recovery of (iii) identify like or directly treatment. See 19 CFR 201.6. Documents antitrust plaintiffs to actual damages competitive articles that complainant, for which confidential treatment by the under specified circumstances. its licensees, or third parties make in the Commission is properly sought will be Specifically, DHD Audio GmbH, United States which could replace the treated accordingly. All information, Leipzig, GERMANY; and Philip Soares subject articles if they were to be including confidential business (individual member), Bellevue, WA, excluded; information and documents for which have been added as parties to this (iv) indicate whether complainant, confidential treatment is properly venture. complainant’s licensees, and/or third sought, submitted to the Commission for Also, Univision, Teaneck, NJ; party suppliers have the capacity to purposes of this Investigation may be SuperSport, Johannesburg, SOUTH replace the volume of articles disclosed to and used: (i) By the AFRICA; Xytech Systems Corporation, potentially subject to the requested Commission, its employees and Offices, Mission Hills, CA; Iain Collins exclusion order and/or a cease and and contract personnel (a) for (individual member), London, UNITED desist order within a commercially developing or maintaining the records KINGDOM; and Keith Ian Graham reasonable time; and of this or a related proceeding, or (b) in (individual member), San Jose, CA, have (v) explain how the requested internal investigations, audits, reviews, withdrawn as parties to this venture. remedial orders would impact United and evaluations relating to the No other changes have been made in States consumers. programs, personnel, and operations of either the membership or planned Written submissions on the public the Commission including under 5 activity of the group research project. interest must be filed no later than by U.S.C. Appendix 3; or (ii) by U.S. Membership in this group research close of business, eight calendar days government employees and contract project remains open, and Advanced after the date of publication of this personnel,2 solely for cybersecurity Media Workflow Association, Inc. notice in the Federal Register. There purposes. All nonconfidential written intends to file additional written will be further opportunities for submissions will be available for public notifications disclosing all changes in comment on the public interest after the inspection at the Office of the Secretary membership. issuance of any final initial and on EDIS.3 On March 28, 2000, Advanced Media determination in this investigation. Any This action is taken under the Workflow Association, Inc. filed its written submissions on other issues authority of section 337 of the Tariff Act original notification pursuant to Section should be filed no later than by close of 6(a) of the Act. The Department of business nine calendar days after the 1 Handbook for Electronic Filing Procedures: Justice published a notice in the Federal date of publication of this notice in the https://www.usitc.gov/documents/handbook_on_ Register pursuant to Section 6(b) of the _ Federal Register. Complainant may file filing procedures.pdf. Act on June 29, 2000 (65 FR 40127). 2 All contract personnel will sign appropriate a reply to any written submission no nondisclosure agreements. The last notification was filed with later than the date on which 3 Electronic Document Information System the Department on June 22, 2018. A complainant’s reply would be due (EDIS): https://edis.usitc.gov. notice was published in the Federal

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Register pursuant to Section 6(b) of the DEPARTMENT OF LABOR collection request. In addition, Act on July 18, 2018 (83 FR 33949). comments, regardless of the delivery Employment and Training method, will be posted without change Suzanne Morris, Administration on the http://www.regulations.gov Chief, Premerger and Division Statistics Unit, website; consequently, the Department Antitrust Division. Agency Information Collection recommends comments not include [FR Doc. 2018–20497 Filed 9–19–18; 8:45 am] Activities; Comment Request; Data personal information such as social BILLING CODE 4410–11–P Collections From Industry-Recognized security number, personal address, Apprenticeship Program Accreditors telephone number, email address, or AGENCY: Employment and Training confidential business information that DEPARTMENT OF JUSTICE Administration, Labor. they do not want made public. It is the responsibility of the commenter to ACTION: Notice. Antitrust Division determine what to include in the public SUMMARY: The Department of Labor record. Notice Pursuant to the National (DOL), Employment and Training FOR FURTHER INFORMATION CONTACT: Cooperative Research and Production Administration (ETA), is soliciting Mark Judge by telephone at 202–693– Act of 1993—PXI Systems Alliance, comments concerning proposed 3470 (this is not a toll-free number) or Inc. authority to conduct the voluntary by email at [email protected]. information collection request (ICR) SUPPLEMENTARY INFORMATION: DOL, as Notice is hereby given that, on titled, ‘‘Industry-Recognized part of its continuing efforts to reduce September 4, 2018, pursuant to Section Apprenticeship Programs Accrediting paperwork and respondent burden, 6(a) of the National Cooperative Entity Information.’’ This comment conducts a pre-clearance consultation Research and Production Act of 1993, request is part of continuing program to provide the general public 15 U.S.C. 4301 et seq. (‘‘the Act’’), PXI Departmental efforts to reduce and Federal agencies an opportunity to Systems Alliance, Inc. (‘‘PXI Systems’’) paperwork and respondent burden in comment on proposed and/or has filed written notifications accordance with the Paperwork continuing collections of information simultaneously with the Attorney Reduction Act of 1995 (PRA). before submitting them to OMB for final General and the Federal Trade DATES: Consideration will be given to all approval. This program helps to ensure Commission disclosing changes in its written comments received by requested data can be provided in the membership. The notifications were November 19, 2018. desired format, reporting burden (time filed for the purpose of extending the ADDRESSES: Comments submitted in and financial resources) is minimized, Act’s provisions limiting the recovery of response to this notice should be collection instruments are clearly antitrust plaintiffs to actual damages submitted electronically through the understood, and the impact of collection under specified circumstances. Federal eRulemaking Portal at http:// requirements can be properly assessed. Specifically, Power Value Technologies www.regulations.gov by selecting ETA has requested that OMB approve Co., LTD, Shanghai, PEOPLE’S Docket ID number ETA–2018–0001 or an Information Collection Request pursuant to the Paperwork Reduction REPUBLIC OF CHINA, has been added via postal mail, commercial delivery, or Act. If approved, this request will as a party to this venture. hand delivery. A copy of this ICR with applicable supporting documentation; enable ETA to collect essential data No other changes have been made in including a description of the likely under Training and Employment Notice either the membership or planned respondents, proposed frequency of (TEN) No. 3–18 concerning the activity of the group research project. response, and estimated total burden operational characteristics of certain Membership in this group research may be obtained free of charge from industry-recognized apprenticeship project remains open, and PXI Systems http://www.regulations.gov or by programs that are being established intends to file additional written contacting Mark Judge by telephone at under the statutory authority of the Act 1 notifications disclosing all changes in 202–693–3470 (this is not a toll-free (located at 29 U.S.C. 50). On June 15, 2017, President Trump membership. number), or by email at IRAP.PRA@ issued Executive Order 13801, entitled On November 22, 2000, PXI Systems dol.gov. Individuals with hearing or ‘‘Expanding Apprenticeships in speech impairments may access the filed its original notification pursuant to America,’’ which directed the Secretary telephone number above via TTY by Section 6(a) of the Act. The Department of Labor (in consultation with the calling the toll-free Federal Information of Justice published a notice in the Secretaries of Education and Commerce) Federal Register pursuant to Section Relay Service at 1–877–889–5627 (TTY/ TDD). 6(b) of the Act on March 8, 2001 (66 FR 1 Please note that the projected duties of program 13971). Submit written comments about, or ‘‘certifiers’’ (as referenced in TEN 3–18) in assessing requests for a copy of, this ICR by mail the quality and rigor of industry-recognized The last notification was filed with or courier to the U.S. Department of apprenticeship programs are the same job functions the Department on June 14, 2018. A Labor, Employment and Training traditionally performed by accreditation bodies. notice was published in the Federal Accreditation is a statement from an accreditation Administration, Office of body—an independent organization that oversees Register pursuant to Section 6(b) of the Apprenticeship, Room C–5321, U.S. the development of voluntary consensus Act on July 9, 2018 (83 FR 31774). Department of Labor, 200 Constitution standards—declaring that another entity offering Avenue NW, Washington, DC 20210; or credentials, education, and/or training within a Suzanne Morris, program (such as an industry-recognized by email: [email protected]. apprenticeship program) has met specified Chief, Premerger and Division Statistics Unit, Comments submitted in response to Antitrust Division. certification standards. Additional information on this comment request will become a accreditation bodies can be found at the website of [FR Doc. 2018–20499 Filed 9–19–18; 8:45 am] matter of public record and will be the American National Standards Institute: https:// _ BILLING CODE 4410–11–P www.standardsportal.org/usa en/resources/ summarized and included in the request USaccreditation_bodies.aspx. The Department for Office of Management and Budget intends to elaborate further upon these (OMB) approval of the information accreditation duties in amending 29 CFR part 29.

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to consider ‘‘proposing regulations, satisfied the foregoing criteria, the whether the information will have consistent with applicable law, Department proposes the development practical utility; including 29 U.S.C. 50, that promote the of a form titled ‘‘Industry-Recognized • Evaluate the accuracy of the development of apprenticeship Apprenticeship Programs Accrediting agency’s estimate of the burden of the programs.’’ Under section 4(a) of the Entity Information,’’ intended for proposed collection of information, Executive Order, these accreditors may completion by the accrediting entity, including the validity of the include trade and industry groups, that will enable the Department to methodology and assumptions used; companies, non-profit organizations, determine whether that entity’s • Enhance the quality, utility, and unions, and joint labor-management standards meet the criteria outlined in clarity of the information to be organizations. Section 4(a) also directs the TEN. An electronic version of this collected; and the Department to determine how information collection form will be • Minimize the burden of the qualified accreditors may provide posted on the Department’s website, and collection of information on those who recognition to ‘‘industry-recognized will be capable of being completed and are to respond, including through the apprenticeship programs,’’ and to submitted online. use of appropriate automated, ‘‘establish guidelines or requirements Under the National Apprenticeship electronic, mechanical, or other that qualified [accreditors] should or Act of 1937, the Secretary of Labor is technological collection techniques or must follow to ensure that [the industry- charged with the establishment of labor other forms of information technology, recognized] apprenticeship programs standards designed to safeguard the e.g., permitting electronic submission of they recognize meet quality standards.’’ welfare of apprentices and promote responses. The Secretary has determined to move apprenticeship opportunity. Pursuant to Agency: DOL–ETA. forward with the development of the this statutory authority, and in Type of Review: New. industry-recognized apprenticeship furtherance of the policy objectives Title of Collection: Data Collections programs contemplated by the foregoing stated in Executive Order 13801, the from Industry-Recognized Programs provisions of the Executive Order. To Secretary has determined that the Accreditors. accomplish this goal, the Department immediate establishment of industry- Form: Industry-Recognized issued an interim informational and recognized apprenticeship programs is a Apprenticeship Programs Accrediting guidance document (TEN No., 3–18) on matter of vital national interest. 44 Entity Information. July 27, 2018 titled ‘‘Creating Industry- U.S.C. 3506(c)(2)(A) authorizes this OMB Control Number: 1205–0NEW. Recognized Apprenticeship Programs to information collection. Affected Public: Individuals/ Expand Opportunity in America.’’ This information collection is subject households, state/local/tribal According to the TEN, these new to the PRA. A Federal agency generally governments, Federal government, industry-recognized apprenticeship cannot conduct or sponsor a collection private sector (businesses or other for- programs will be reviewed and of information, and the public is profits, and, not-for-profit institutions). recognized by qualified accrediting generally not required to respond to an Estimated Total Annual Respondents: entities; the accrediting entities, in turn, information collection, unless OMB 308. may request a determination from the under the PRA approves it and displays Estimated Number of Respondents: Department concerning their a currently valid OMB Control Number. 308. qualifications to act as a accreditor. The In addition, notwithstanding any other Frequency: Generally, once every five Department intends to promulgate a provisions of law, no person shall years. regulation amending 29 CFR part 29; generally be subject to penalty for Total Estimated Annual Responses: this regulation would, among other 308. things, establish guidelines or failing to comply with a collection of Estimated Average Time per requirements that qualified entities information that does not display a Response: 82 minutes. must follow to ensure that the industry- valid Control Number. See 5 CFR Estimated Total Annual Burden recognized programs they accredit meet 1320.5(a) and 1320.6. Hours: 6,980. quality standards. Interested parties are encouraged to The TEN provides interim provide comments to the contact shown Total Estimated Annual Other Cost information and guidance to accreditors in the ADDRESSES section of this notice. Burden: $0. on the process for obtaining a Comments must be written to receive Rosemary Lahasky, consideration, and they will be determination from the Department on Deputy Assistant Secretary for the whether that entity’s standards meet the summarized and included in the request Employment and Training Administration. for OMB approval of the final ICR. In criteria outlined in TEN No. 3–18. To [FR Doc. 2018–20436 Filed 9–19–18; 8:45 am] order to help ensure appropriate obtain a favorable determination from BILLING CODE 4510–FR–P the Department, the accrediting entity consideration, comments should should, among other things, mention 1205–0NEW. demonstrate that it has received broad Submitted comments will also be a DEPARTMENT OF LABOR sector-wide input and consensus in the matter of public record for this ICR and setting of industry-wide quality posted on the internet, without [Agency Docket Number DOL–2018–0005] standards. The accrediting entity should redaction. DOL encourages commenters also demonstrate that their program not to include personally identifiable Notice of Publication of 2018 Update to accreditation process ensures that the information, confidential business data, the Department of Labor’s List of industry programs will operate in a or other sensitive statements/ Goods Produced by Child Labor or manner consistent with DOL-identified information in any comments. DOL is Forced Labor hallmarks of high-quality particularly interested in comments AGENCY: Office of the Secretary, Bureau apprenticeship programs. To collect the that: of International Labor Affairs, • information necessary for the Evaluate whether the proposed Department of Labor. Department to determine whether the collection of information is necessary ACTION: Announcement of public entity accrediting these industry- for the proper performance of the availability of updated list of goods. recognized apprenticeship programs has functions of the agency, including

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SUMMARY: This notice announces the Signed at Washington, DC, this 13th day of page: https://science.nasa.gov/ publication of an updated list of September 2018. researchers/nac/science-advisory- goods—along with countries of origin— Martha E. Newton, committees/apac. that the Bureau of International Labor Deputy Undersecretary for International It is imperative that the meeting be Affairs (ILAB) has reason to believe are Affairs. held on this date to accommodate the produced by child labor or forced labor [FR Doc. 2018–20391 Filed 9–19–18; 8:45 am] scheduling priorities of the key in violation of international standards BILLING CODE 4510–28–P participants. (TVPRA List). ILAB is required to develop and make available to the Patricia Rausch, public the TVPRA List pursuant to the NATIONAL AERONAUTICS AND Advisory Committee Management Officer, Trafficking Victims Protection National Aeronautics and Space SPACE ADMINISTRATION Administration. Reauthorization Act (TVPRA) of 2005, as amended. [Notice: (18–070)] [FR Doc. 2018–20426 Filed 9–19–18; 8:45 am] BILLING CODE 7510–13–P FOR FURTHER INFORMATION CONTACT: NASA Astrophysics Advisory Rachel Rigby, Office of Child Labor, Committee; Meeting Forced Labor, and Human Trafficking, AGENCY: National Aeronautics and Bureau of International Labor Affairs, Space Administration. NATIONAL SCIENCE FOUNDATION U.S. Department of Labor, at (202) 693– 4843 (this is not a toll-free number). ACTION: Notice of meeting. Notice of Permit Applications Received Under the Antarctic Conservation Act SUPPLEMENTARY INFORMATION: The SUMMARY: In accordance with the Bureau of International Labor Affairs Federal Advisory Committee Act, as of 1978 (ILAB) announces the publication of the amended, the National Aeronautics and AGENCY: National Science Foundation. eighth edition of the List of Goods Space Administration (NASA) ACTION: Notice of permit applications Produced by Child Labor or Forced announces a meeting of the received. Labor (TVPRA List), pursuant to the Astrophysics Advisory Committee. This Trafficking Victims Protection Committee reports to the Director, SUMMARY: The National Science Reauthorization Act (TVPRA) of 2005, Astrophysics Division, Science Mission Foundation (NSF) is required to publish as amended. ILAB published the initial Directorate, NASA Headquarters. The a notice of permit applications received TVPRA List on September 10, 2009, and meeting will be held for the purpose of to conduct activities regulated under the has since published seven updated soliciting, from the scientific Antarctic Conservation Act of 1978. editions. The 2018 edition adds 10 new community and other persons, scientific NSF has published regulations under goods (amber, bovines, cabbages, and technical information relevant to the Antarctic Conservation Act in the carrots, cereal grains, lettuce, mica, program planning. Code of Federal Regulations. This is the peppers, sheep, and sweet potatoes) DATES: Monday, October 22, 2018, 11:00 required notice of permit applications from particular countries and one new a.m.–5:00 p.m.; and Tuesday, October received. country (Eswatini) to the TVPRA List. 23, 2018, 11:00 a.m.–5:00 p.m., Eastern This edition also features the removal Time. DATES: Interested parties are invited to submit written data, comments, or from the TVPRA List of physic nuts FOR FURTHER INFORMATION CONTACT: Ms. from Burma produced by forced labor, KarShelia Henderson, Science Mission views with respect to this permit sugarcane from Panama produced by Directorate, NASA Headquarters, application by October 22, 2018. This child labor, and cotton from both Washington, DC 20546, (202) 358–2355, application may be inspected by Paraguay and Uzbekistan produced by fax (202) 358–2779, or khenderson@ interested parties at the Permit Office, child labor. nasa.gov. address below. ADDRESSES: Comments should be Section 105(b) of the TVPRA SUPPLEMENTARY INFORMATION: The addressed to Permit Office, Office of mandates that ILAB develop and meeting will be open to the public Polar Programs, National Science publish a list of goods from countries telephonically and by WebEx. You must Foundation, 2415 Eisenhower Avenue, that ILAB ‘‘has reason to believe are use a touch-tone phone to participate in Alexandria, Virginia 22314. produced by forced labor or child labor this meeting. Any interested person may in violation of international standards.’’ dial the USA toll free conference call FOR FURTHER INFORMATION CONTACT: 22 U.S.C. 7112(b)(2). ILAB’s Office of number 1–888–324–2912 or toll number Nature McGinn, ACA Permit Officer, at Child Labor, Forced Labor, and Human 1–312–470–7002, passcode 7682264, to the above address, 703–292–8030, or Trafficking (OCFT) carries out this participate in this meeting by telephone [email protected]. mandate. The primary purposes of the on both days. The WebEx link is https:// SUPPLEMENTARY INFORMATION: The TVPRA List are to raise public nasa.webex.com/; the meeting number National Science Foundation, as awareness about the incidence of child on October 22 is 991 683 794, password directed by the Antarctic Conservation labor and forced labor in the production is APAC1018#; and the meeting number Act of 1978 (Pub. L. 95–541, 45 CFR of goods in the countries listed and to on October 23 is 998 343 087, password 670), as amended by the Antarctic promote efforts to eliminate such is APAC1018#. Science, Tourism and Conservation Act practices. A full report, including the The agenda for the meeting includes of 1996, has developed regulations for updated TVPRA List and a discussion of the following topics: the establishment of a permit system for the TVPRA List’s methodology, as well • Astrophysics Division Update various activities in Antarctica and as Frequently Asked Questions and a • Updates on Specific Astrophysics designation of certain animals and bibliography of sources, are available on Missions certain geographic areas a requiring the Department of Labor website at: • Reports from the Program Analysis special protection. The regulations http://www.dol.gov/ilab/reports/child- Groups establish such a permit system to labor/list-of-goods/. The agenda will be posted on the designate Antarctic Specially Protected Authority: 22 U.S.C. 7112(b)(2)(C). Astrophysics Advisory Committee web Areas.

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Application Details ASPAs visited. The results of this work Dated: September 17, 2018. are expected to be useful for outreach Crystal Robinson, Permit Application: 2019–007 and education about Antarctica and the Committee Management Officer. 1. Applicant scientific research conducted there. National Science Foundation, 2415 Natasja van Gestel, Texas Tech Location: ASPA 121, Cape Royds, Eisenhower Avenue, Alexandria, VA 22314 University, Biological Sciences Ross Island; ASPA 155, Cape Evans, Department, 2901 Main Street, Lubbock, Ross Island; ASPA 157, Backdoor Bay, Partnerships for International Research and TX 79409. Cape Royds, Ross Island; ASPA 158, Education (PIRE) Activity for Which Permit Is Hut Point, Ross Island; ASPA 172, Reverse Site Visit Agenda—NSF Room Requested: Enter Antarctic Specially Lower Taylor Glacier and Blood Falls, C3010 Protected Area, collect soil and Taylor Valley; McMurdo Station area; Thursday, October 25, 2018 vegetation samples. The applicant McMurdo Dry Valleys. 8:00 a.m. Panelists arrive. Coffee/light proposes to enter Antarctic Specially Dates of Permitted Activities: October Protected Area (ASPA) 113, Litchfield refreshments available. 22–November 19, 2018. 8:15 a.m.–8:45 a.m. Panel Orientation— Island, Arthur Harbor, to study (CLOSED) Suzanne H. Plimpton, Antarctic soils, microbial communities, PIRE Rationale and Goals, Charge to Panel and vegetation. The studies would Reports Clearance Officer, National Science 8:45 a.m. PIs arrive. Introductions. (OPEN) involve short-term, temporary Foundation. 9:00 a.m.–11:30 a.m. PIRE Project installation of chambers around study [FR Doc. 2018–20470 Filed 9–19–18; 8:45 am] Presentation should cover the following: plots; temporary installations of data BILLING CODE 7555–01–P (OPEN) loggers, sensors, and gauges; minimal Research soil sample collection; and collection of Integrating Research & Education minimal vegetation samples. The NATIONAL SCIENCE FOUNDATION Students (e.g. involvement in project, recruitment, diversity) applicant would collect 5 plants each of Proposal Review Panel for Project Management and Communication the species Deschampsia antarctica and Evaluation & Assessment Colobanthus quitensis and up to 20 International Science and Engineering; Notice of Meeting Institutional Support small samples of various moss species. International Partnerships Moss samples would be collected near In accordance with the Federal 11:30 a.m.–12:30 p.m. Questions and Answers Palmer Station preferentially, if species Advisory Committee Act (Pub. L. 92– are available there. All samples would 12:30 p.m.—2:00 p.m. Working Lunch— 463, as amended), the National Science Panel Discussion—(CLOSED) be taken to the home institution for Foundation (NSF) announces the analysis and, ultimately, herbarium 2:00 p.m.–2:30 p.m. Initial Feedback to following meeting: Project Team (CLOSED) curation. Name and Committee Code: Proposal 2:30 p.m. PIRE PI and presenters are Location: ASPA 113, Litchfield dismissed Island, Arthur Harbor; Anvers Island, Review Panel for Office of International Science and Engineering—PIRE: 2:30 p.m.–4:30 p.m. Panel meets for Reverse Palmer Station area. Site Visit Report Dates of Permitted Activities: Translating Cognitive and Brain Science Preparation—(CLOSED) December 5, 2018–April 10, 2019. in the Laboratory and Field to Language 4:30 p.m.–4:45 p.m. Report presented to Learning Environments—Reverse Site and discussion held with NSF staff— Permit Application: 2019–008 Visit (#10749). (CLOSED) 2. Applicant Date and Time: October 25, 2018; 8:00 5:00 p.m. End of Reverse Site Visit Caitlin Saks, WGBH, 1 Guest Street, a.m.–5:00 p.m. [FR Doc. 2018–20454 Filed 9–19–18; 8:45 am] Boston, MA 02135. Place: National Science Foundation, BILLING CODE 7555–01–P Activity for Which Permit Is 2415 Eisenhower Avenue, Alexandria, Requested: Enter Antarctic Specially Virginia 22314. NATIONAL SCIENCE FOUNDATION Protected Areas (ASPA). The applicant Type of Meeting: Part-Open. would enter ASPA 121, Cape Royds, Contact Person: Cassandra Dudka, Advisory Committee for Education and Ross Island; ASPA 155, Cape Evans, PIRE Program Manager, National Human Resources; Notice of Meeting Ross Island; ASPA 157, Backdoor Bay, Science Foundation, 2415 Eisenhower Cape Royds, Ross Island; ASPA 158, Avenue, Alexandria, VA 22314; In accordance with the Federal Hut Point, Ross Island; ASPA 172, Telephone 703/292–7250. Advisory Committee Act (Pub. L. 92– Lower Taylor Glacier and Blood Falls, 463, as amended), the National Science Taylor Valley to film scientific research Purpose of Meeting: NSF reverse site Foundation (NSF) announces the being conducted, historically significant visit to conduct a review during year 3 following meeting: locations, and the natural environment. of the five-year award period. To Name and Committee Code: Advisory The resulting film and photography conduct an in-depth evaluation of Committee for Education and Human would be used to create a series of performance, to assess progress towards Resources (EHR) (#1119). media products including a two-hour goals, and to provide recommendations. Date and Time: October 18, 2018; 8:00 documentary. The applicant proposes to Agenda: See attached. a.m.–5:00 p.m. employ a video-camera and tripod, Reason for Closing: Topics to be October 19, 2018; 8:00 a.m.–2:00 p.m. possibly a light stand (inside historic discussed and evaluated during closed Place: National Science Foundation, huts), a 360 degree virtual reality portions of the site review will include 2415 Eisenhower Avenue, Room E2020, camera, and, where feasible and information of a proprietary or Alexandria, VA 22314. allowable, a small, remotely piloted confidential nature, including technical To attend the meeting in person, all aircraft system with a camera payload. information; and information on visitors must contact the Directorate for The applicant would enter the historic personnel. These matters are exempt Education and Human Resources at huts with a trained guide and would under 5 U.S.C. 552b(c), (4) and (6) of the least 48 hours prior to the meeting to abide by the management plans of all Government in the Sunshine Act. arrange for a visitor’s badge. All visitors

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must access NSF via the Visitor Center NUCLEAR REGULATORY telephone: 301–415–3053; email: entry adjacent to the south building COMMISSION [email protected]; U.S. Nuclear Regulatory Commission, Washington, entrance on Eisenhower Avenue on the [NRC–2018–0145] day of the meeting to receive a visitor’s DC 20555–0001. badge. It is suggested that visitors allow Proposed Revisions to Branch SUPPLEMENTARY INFORMATION: time to pass through security screening. Technical Position 5–3: Fracture I. Obtaining Information and Type of Meeting: Open. Toughness Requirements Submitting Comments Contact Person: Keaven M. Stevenson, AGENCY: Nuclear Regulatory A. Obtaining Information National Science Foundation, 2415 Commission. Please refer to Docket ID NRC–2018– Eisenhower Avenue, Room C11001, ACTION: Standard review plan—draft 0145 when contacting the NRC about Alexandria, VA 22314; (703) 292–8600/ section revision; reopening of comment the availability of information for this [email protected]. period. action. You may obtain publicly- Summary of Minutes: Minutes and SUMMARY: On July 13, 2018, the U.S. available information related to this meeting materials will be available on Nuclear Regulatory Commission (NRC) action by any of the following methods: the EHR Advisory Committee website at published a request for public comment • Federal Rulemaking Website: Go to http://www.nsf.gov/ehr/advisory.jsp or on draft NUREG–0800, ‘‘Standard http://www.regulations.gov and search can be obtained from Dr. Ellen McCallie, Review Plan for the Review of Safety for Docket ID NRC–2018–0145. National Science Foundation, 2415 Analysis Reports for Nuclear Power • NRC’s Agencywide Documents Eisenhower Ave., Room C11233, Plants: LWR Edition,’’ Branch Technical Access and Management System Alexandria, VA 22314; (703) 292–8600; Position (BTP) 5–3, ‘‘Fracture (ADAMS): You may obtain publicly- [email protected]. Toughness Requirements.’’ The public available documents online in the ADAMS Public Documents collection at Purpose of Meeting: To provide comment period was originally http://www.nrc.gov/reading-rm/ advice with respect to the Foundation’s scheduled to close on September 11, adams.html. To begin the search, select science, technology, engineering, and 2018. The NRC has decided to reopen the public comment period on this ‘‘Begin Web-based ADAMS Search.’’ For mathematics (STEM) education and problems with ADAMS, please contact human resources programming. document for 30 days to allow more time for members of the public to the NRC’s Public Document Room (PDR) Agenda review additional revisions that the reference staff at 1–800–397–4209, 301– NRC made to BTP 5–3 since the draft 415–4737, or by email to pdr.resource@ Thursday, October 18, 2018, 8:00 a.m.– was issued on July 13, 2018, and to nrc.gov. 5:00 p.m. assemble and submit their comments. NRC’s PDR: You may examine and DATES: The comment period for the purchase copies of public documents at Remarks by the EHR AC Committee the NRC’s PDR, Room O1–F21, One Chair and the EHR Assistant document published on July 13, 2018 (83 FR 32690) has been reopened. White Flint North, 11555 Rockville Director for Education and Human Pike, Rockville, Maryland 20852. Resources (EHR). Comments must be filed no later than October 22, 2018. Comments received B. Submitting Comments Public Private Partnerships. after this date will be considered, if it Please include Docket ID NRC–2018– STEM Education of the Future. is practical to do so, but the 0145 in your comment submission. Commission is able to ensure Mid-scale Research Infrastructure. The NRC cautions you not to include consideration only for comments identifying or contact information that Broadening Participation. received on or before this date. Discussion with France Co´rdova, NSF you do not want to be publicly ADDRESSES: You may submit comments disclosed in your comment submission. Director and F. Fleming Crim, Chief by any of the following methods: The NRC will post all comment Operating Officer. • Federal Rulemaking Website: Go to submissions at http:// Friday, October 19, 2018, 8:00 a.m.–2:00 http://www.regulations.gov and search www.regulations.gov as well as enter the p.m. for Docket ID NRC–2018–0145. Address comment submissions into ADAMS. questions about Docket IDs in The NRC does not routinely edit Day 1 Recap. Regulations.gov to Jennifer Borges; comment submissions to remove Quick briefings. telephone: 301–287–9127; email: identifying or contact information. [email protected]. For technical If you are requesting or aggregating Update on EHR Programs. questions, contact the individual listed comments from other persons for Update on Subcommittees Reflections in the FOR FURTHER INFORMATION submission to the NRC, then you should from the EHR AD. CONTACT section of this document. inform those persons not to include • Committee Business. Mail comments to: May Ma, Office identifying or contact information that of Administration, Mail Stop: TWFN 7 they do not want to be publicly Advisory Committee Recommendations. A60M, U.S. Nuclear Regulatory disclosed in their comment submission. Final agenda can be located on the Commission, Washington, DC 20555– Your request should state that the NRC EHR AC website: https://www.nsf.gov/ 0001. does not routinely edit comment ehr/advisory.jsp. For additional direction on obtaining submissions to remove such information information and submitting comments, before making the comment Dated: September 17, 2018. see ‘‘Obtaining Information and submissions available to the public or Crystal Robinson, Submitting Comments’’ in the entering the comment into ADAMS. Committee Management Officer. SUPPLEMENTARY INFORMATION section of II. Further Information [FR Doc. 2018–20453 Filed 9–19–18; 8:45 am] this document. BILLING CODE 7555–01–P FOR FURTHER INFORMATION CONTACT: On July 13, 2018 (83 FR 32690), the Mark D. Notich, Office of New Reactors, NRC published a request for public

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comment on draft NUREG–0800, DATES: The effective date of the nuclear power plants to incorporate ‘‘Standard Review Plan for the Review withdrawal of RG 5.68 is September 20, requirements that were issued through of Safety Analysis Reports for Nuclear 2018. Commission orders as a result of the Power Plants: LWR Edition,’’ BTP 5–3, ADDRESSES: Please refer to Docket ID September 11, 2001, terrorist attacks (74 ‘‘Fracture Toughness Requirements,’’ NRC–2018–0206 when contacting the FR 13925). In addition, the rulemaking (ADAMS Accession No. ML18081A184). NRC about the availability of added several new requirements This section has been developed to information regarding this document. consistent with insights gained from assist NRC staff in reviewing You may obtain publicly-available implementation of the orders, review of applications submitted per the information related to this document site security plans, implementation of requirements under part 50 of title 10 of using any of the following methods: the enhanced baseline inspection the Code of Federal Regulations (10 • Federal Rulemaking Website: Go to program, and NRC evaluation of force- CFR). http://www.regulations.gov and search on-force exercises. Since RG 5.68 was The public comment period was for Docket ID NRC–2018–0206. Address published in August 1994, it does not originally closed on September 11, questions about NRC dockets in account for the updated requirements of 2018. The NRC has included additional Regulations.gov to Jennifer Borges; 10 CFR part 73. As a result, the revisions to the text of BTP 5–3 since telephone: 301–287–9127; email: guidance in RG 5.68 is outdated. In the section was issued for comment. [email protected]. For technical addition, the NRC is withdrawing RG Accordingly, the NRC has decided to questions, contact the individuals listed 5.68 because it has been superseded by reopen the public comment period on in the FOR FURTHER INFORMATION updated guidance that can be found in this document to allow more time for CONTACT section of this document. other regulatory documents. These members of the public to assemble and • NRC’s Agencywide Documents documents provide licensees with submit their comments. The revised text Access and Management System acceptable approaches to address for BTP 5–3 can be found in (ADAMS): You may obtain publicly- various issues, including vehicle access ML18254A090. The redline/strikeout available documents online in the controls, use of explosives, target set comparing the current version of BTP 5– ADAMS Public Documents collection at identification and the appropriate use of 3 and the revised version can be found http://www.nrc.gov/reading-rm/ vehicles. in ML18257A032. adams.html. To begin the search, select II. Further Information Dated at Rockville, Maryland, this 17th day ‘‘Begin Web-based ADAMS Search.’’ For problems with ADAMS, please contact The withdrawal of RG 5.68 does not of September 2018. alter any prior or existing NRC licensing For the Nuclear Regulatory Commission. the NRC’s Public Document Room (PDR) reference staff at 1–800–397–4209, 301– approval or the acceptability of licensee Jennivine K. Rankin, 415–4737, or by email to pdr.resource@ commitments made in accordance with Acting Branch Chief, Licensing Branch 3, nrc.gov. The ADAMS accession number the withdrawn guidance. Although RG Division of Licensing, Siting, and 5.68 is withdrawn, current licensees Environmental Analysis, Office of New for each document referenced (if it available in ADAMS) is provided the referencing this RG may continue to do Reactors. so, and withdrawal does not affect any [FR Doc. 2018–20451 Filed 9–19–18; 8:45 am] first time that a document is referenced. The basis for withdrawal of RG 5.68 is existing licenses or agreements. BILLING CODE 7590–01–P available in ADAMS under Accession However, by withdrawing RG 5.68, the No. ML18187A345. NRC will no longer approve use of the • NRC’s PDR: You may examine and guidance in future requests or NUCLEAR REGULATORY applications for NRC licensing actions. COMMISSION purchase copies of public documents at the NRC’s PDR, Room O1–F21, One Dated at Rockville, Maryland, this 17th day White Flint North, 11555 Rockville of September, 2018. [NRC–2018–0206] Pike, Rockville, Maryland 20852. For the Nuclear Regulatory Commission. Protection Against Malevolent Use of FOR FURTHER INFORMATION CONTACT: Thomas H. Boyce, Vehicles at Nuclear Power Plants Bernard Stapleton, telephone: 301–287– Chief, Regulatory Guidance and Generic 3532, email: [email protected], Issues Branch, Division of Engineering, Office AGENCY: Nuclear Regulatory or Mekonen Bayssie, telephone: 301– of Nuclear Regulatory Research. Commission. 415–1699, email: Mekonen.Bayssie@ [FR Doc. 2018–20476 Filed 9–19–18; 8:45 am] ACTION: Regulatory guide; withdrawal. nrc.gov; U.S. Nuclear Regulatory BILLING CODE 7590–01–P Commission, Washington, DC 20555– SUMMARY: The U.S. Nuclear Regulatory 0001. Both are staff of the U.S. Nuclear Commission (NRC) is withdrawing Regulatory Commission, Washington, NUCLEAR REGULATORY Regulatory Guide (RG) 5.68, ‘‘Protection DC 20555–0001. COMMISSION against Malevolent use of Vehicles at SUPPLEMENTARY INFORMATION: [Docket Nos. 50–247 and 50–286; NRC– Nuclear Power Plants,’’ dated August 2008–0672] 1994. This document is being I. Background withdrawn because it is outdated and The NRC is withdrawing RG 5.68, Entergy Nuclear Operations, Inc.: has been superseded by other NRC ‘‘Protection against Malevolent use of Indian Point Nuclear Generating Unit guidance. Therefore, it no longer Vehicles at Nuclear Power Plants,’’ Nos. 2 and 3 provides methods that the NRC staff because the guidance contained in the AGENCY: Nuclear Regulatory finds acceptable to protect against the document is outdated, has been Commission. malevolent use of vehicles as a means superseded by new guidance, and ACTION: License renewal and record of to gain unauthorized access to protected therefore is no longer acceptable to meet decision; issuance. areas and vital areas and to ensure that NRC regulatory requirements. In these vehicles are operated only by particular, on March 27, 2009, the NRC SUMMARY: The U.S. Nuclear Regulatory authorized persons with a legitimate issued a revised rule that enhanced the Commission (NRC) has issued renewed need for access. security requirements pertaining to Facility Operating License Nos. DPR–26

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and DPR–64 to Entergy Nuclear I. Introduction reasonable alternatives to license Operations, Inc. (Entergy or licensee), Notice is hereby given that the NRC renewal that included natural gas for Indian Point Nuclear Generating has issued Renewed Facility Operating combined-cycle (NGCC); purchased Unit Nos. 2 (IP2) and 3 (IP3). Renewed License Nos. DPR–26 and DPR–64 to electric power; conservation; Facility Operating License Nos. DPR–26 Entergy Nuclear Operations, Inc. combination alternative 1 (license and DPR–64 authorize Entergy to (Entergy or licensee), for the Indian renewal of either IP2 or IP3 along with operate IP2 and IP3 at reactor core Point Nuclear Generating Unit Nos. 2 wind power, hydropower, biomass power levels not in excess of 3,216 (IP2) and 3 (IP3). IP2 and IP3 are fuels, landfill-gas fuels, and megawatts thermal for each unit, in pressurized-water reactors located in conservation); combination alternative 2 accordance with the provisions of the Buchanan, NY (24 miles north of New (fossil-fired power (combined-cycle) IP2 and IP3 renewed licenses and York City, NY). Renewed Facility with wind power, biomass fuels, technical specifications. In addition, the Operating License Nos. DPR–26 and hydropower, landfill-gas fuels, and NRC has prepared a Record of Decision DPR–64 authorize the licensee to conservation); the no-action alternative; (ROD) that supports the NRC’s decision operate IP2 and IP3 at reactor core and operation of IP2 and IP3 using to issue renewed Facility Operating power levels not in excess of 3,216 cooling towers. The FSEIS and FSEIS License Nos. DPR–26 and DPR–64. megawatts thermal for each unit, in supplements document the environmental review, including the DATES: The NRC issued the Renewed accordance with the provisions of the IP2 and IP3 renewed licenses and determination that the adverse Facility Operating License Nos. DPR–26 environmental impacts of license and DPR–64 on September 17, 2018. technical specifications. The renewed licenses authorize operation of IP2 and renewal for IP2 and IP3 are not so great ADDRESSES: Please refer to Docket ID IP3 until April 30, 2024 and April 30, that preserving the option of license NRC–2008–0672 when contacting the 2025, respectively. The NRC’s record of renewal for energy planning NRC about the availability of decision (ROD) that supports the NRC’s decisionmakers would be unreasonable. information regarding this document. decision to issue Renewed Facility The NRC staff documented the results You may obtain publicly available Operating License Nos. DPR–26 and of its safety review in its ‘‘Safety information related to this document DPR–64 is available in ADAMS under Evaluation Report (SER) Related to the using any of the following methods: Accession No. ML18212A032. License Renewal of Indian Point • Federal Rulemaking Website: Go to The NRC has concluded that the Nuclear Generating Unit Nos. 2 and 3,’’ http://www.regulations.gov and search application for the renewed licenses, issued August 11, 2009 (ADAMS for Docket ID NRC–2008–0672. Address ‘‘Indian Point Energy Center License Accession No. ML092240268). On questions about Docket IDs in Renewal Application,’’ dated April 23, November 30, 2009, the NRC staff Regulations.gov to Jennifer Borges; 2007 (ADAMS Accession No. published its final report in two telephone: 301–287–9127; email: ML071210512), as amended, complies volumes as NUREG–1930, ‘‘Safety [email protected]. For technical with the standards and requirements of Evaluation Report Related to the License questions, contact the individual listed the Atomic Energy Act of 1954, as Renewal of Indian Point Nuclear in the FOR FURTHER INFORMATION amended (the Act), and the NRC’s Generating Unit Nos. 2 and 3’’ (for CONTACT section of this document. regulations. As required by the Act and Volume 1, see ADAMS Accession No. • the NRC’s regulations set forth in title ML093170451 and for Volume 2 see NRC’s Agencywide Documents 10 of the Code of Federal Regulations ADAMS Accession No. ML093170671). Access and Management System (10 CFR), the NRC has made appropriate On August 31, 2011, the NRC staff (ADAMS): You may obtain publicly findings, which are set forth in the issued Supplement 1 to NUREG–1930 available documents online in the renewed licenses. No adjudicatory (ADAMS Accession No. ML11242A215). ADAMS Public Documents collection at matters are pending before the Supplement 1 documents the NRC http://www.nrc.gov/reading-rm/ Commission or the Atomic Safety and staff’s review of supplemental adams.html. To begin the search, select Licensing Board regarding the IP2 and information provided by the applicant ‘‘Begin Web-based ADAMS Search.’’ For IP3 license renewal application. since the issuance of NUREG–1930, problems with ADAMS, please contact The NRC staff published its final including annual updates required by the NRC’s Public Document Room (PDR) supplemental environmental impact 10 CFR 54.21(b), and updated reference staff at 1–800–397–4209, 301– statement (FSEIS) in five volumes of information and commitments in 415–4737, or by email to pdr.resource@ NUREG–1437, Supplement 38, ‘‘Generic response to NRC staff requests for nrc.gov. For the convenience of the Environmental Impact Statement for additional information. On July 31, reader, instructions about obtaining License Renewal of Nuclear Plants 2015, the NRC staff issued Supplement materials referenced in this document Regarding Indian Point Nuclear 2 to NUREG–1930 (ADAMS Accession are provided in the ‘‘Availability of Generating Unit Nos. 2 and 3 (NUREG– No. ML15188A383). Supplement 2 Documents’’ section. 1437, Supplement 38) Final Report.’’ documents the NRC staff’s review of • NRC’s PDR: You may examine and For Volumes 1 through 3, dated supplemental information provided by purchase copies of public documents at December 3, 2010, see ADAMS Package the applicant since the issuance of the NRC’s PDR, Room O1–F21, One Accession No. ML103270072; for Supplement 1, including information White Flint North, 11555 Rockville Volume 4, dated June 30, 2013 (FSEIS committed to by Entergy as documented Pike, Rockville, MD 20852. Supplement 1), see ADAMS Accession in Commitment No. 30 (pertaining to No. ML13162A616; and for Volume 5, reactor vessel internals), annual updates FOR FURTHER INFORMATION CONTACT: dated April 30, 2018 (FSEIS required by 10 CFR 54.21(b), updated William Burton, Office of Nuclear Supplement 2), see ADAMS Accession information and commitments, as well Reactor Regulation, U.S. Nuclear No. ML18107A759. As discussed in the as information provided in response to Regulatory Commission, Washington DC ROD, FSEIS, and FSEIS supplements, NRC staff requests for additional 20555–0001; telephone: 301–415–6332, the NRC has considered the reasonably information. On August 1, 2018, the email: [email protected]. foreseeable impacts of IP2 and IP3 NRC staff issued Supplement 3 to SUPPLEMENTARY INFORMATION: license renewal as well as a range of NUREG–1930 (ADAMS Accession No.

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ML18200A333). Supplement 3 Generating Unit Nos. 2 and 3 renewed Commission or the Atomic Safety and documents the NRC staff’s review of licenses, ‘‘Indian Point Energy Center Licensing Board regarding the IP2 and supplemental information provided by License Renewal Application,’’ dated IP3 license renewal application. the applicant since the issuance of April 23, 2007, as amended, complies Accordingly, the NRC has issued Supplement 2, including annual with the standards and requirements of Renewed Facility Operating License updates required by 10 CFR 54.21(b), the Atomic Energy Act of 1954, as Nos. DPR–26 and DPR–64, authorizing updated information to address new or amended (the Act), and the NRC’s operation of IP2 and IP3 until April 30, updated interim staff guidance, and regulations. As required by the Act and 2024 and April 30, 2025, respectively. recent operating experience. the NRC’s regulations in 10 CFR, the III. Availability of Documents NRC has made appropriate findings, II. Conclusion which are set forth in the renewed The documents identified in the The NRC has determined that the licenses and the ROD. No adjudicatory following table are available to application for the Indian Point Nuclear matters are pending before the interested persons as indicated.

Document ADAMS accession No.

Indian Point Energy Center License Renewal Application,’’ dated April 23, 2007 ...... ML071210512. NUREG-1437, Supplement 38, ‘‘Generic Environmental Impact Statement for License Renewal of Nuclear Plants Re- ML103270072. garding Indian Point Nuclear Generating Unit Nos. 2 and 3 (NUREG–1437, Supplement 38) Final Report.’’ (Vol- umes 1–3, December 3, 2010). NUREG-1437, Supplement 38, ‘‘Generic Environmental Impact Statement for License Renewal of Nuclear Plants Re- ML13162A616. garding Indian Point Nuclear Generating Unit Nos. 2 and 3 (NUREG–1437, Supplement 38) Final Report.’’ (Volume 4, June 30, 2013). NUREG-1437, Supplement 38, ‘‘Generic Environmental Impact Statement for License Renewal of Nuclear Plants Re- ML18107A759. garding Indian Point Nuclear Generating Unit Nos. 2 and 3 (NUREG–1437, Supplement 38) Final Report.’’ (Volume 5, April 30, 2018). ‘‘Safety Evaluation Report (SER) Related to the License Renewal of Indian Point Nuclear Generating Unit Nos. 2 and ML092240268. 3’’ (August 11, 2009). NUREG–1930, ‘‘Safety Evaluation Report (SER) Related to the License Renewal of Indian Point Nuclear Generating ML093170451. Unit Nos. 2 and 3’’ (Volume 1 November 30, 2009). NUREG–1930 ‘‘Safety Evaluation Report (SER) Related to the License Renewal of Indian Point Nuclear Generating ML093170671. Unit Nos. 2 and 3’’ (Volume 2 November 30, 2009). NUREG–1930 ‘‘Safety Evaluation Report (SER) Related to the License Renewal of Indian Point Nuclear Generating ML11242A215. Unit Nos. 2 and 3’’ (August 31, 2011). NUREG–1930 ‘‘Safety Evaluation Report (SER) Related to the License Renewal of Indian Point Nuclear Generating ML15188A383. Unit Nos. 2 and 3’’ (July 31, 2015). NUREG–1930 ‘‘Safety Evaluation Report (SER) Related to the License Renewal of Indian Point Nuclear Generating ML18200A333. Unit Nos. 2 and 3’’ (August 1, 2018). Record of Decision for License Renewal Application For Indian Point Nuclear Generating (September 17, 2018) ...... ML18212A032.

Dated at Rockville, MD, this 17th day of ADDRESSES: Submit comments dominant or the competitive product September 2018. electronically via the Commission’s list. For the Nuclear Regulatory Commission. Filing Online system at http:// Section II identifies the docket George A. Wilson, Jr., www.prc.gov. Those who cannot submit number(s) associated with each Postal Director, Division of Materials and License comments electronically should contact Service request, the title of each Postal Renewal, Office of Nuclear Reactor the person identified in the FOR FURTHER Service request, the request’s acceptance Regulation. INFORMATION CONTACT section by date, and the authority cited by the [FR Doc. 2018–20450 Filed 9–19–18; 8:45 am] telephone for advice on filing Postal Service for each request. For each BILLING CODE 7590–01–P alternatives. request, the Commission appoints an officer of the Commission to represent FOR FURTHER INFORMATION CONTACT: the interests of the general public in the David A. Trissell, General Counsel, at proceeding, pursuant to 39 U.S.C. 505 POSTAL REGULATORY COMMISSION 202–789–6820. (Public Representative). Section II also [Docket Nos. CP2018–216; MC2018–221 and SUPPLEMENTARY INFORMATION: establishes comment deadline(s) CP2018–307] Table of Contents pertaining to each request. The public portions of the Postal New Postal Products I. Introduction Service’s request(s) can be accessed via II. Docketed Proceeding(s) AGENCY: Postal Regulatory Commission. the Commission’s website (http:// I. Introduction www.prc.gov). Non-public portions of ACTION: Notice. the Postal Service’s request(s), if any, The Commission gives notice that the can be accessed through compliance SUMMARY: The Commission is noticing a Postal Service filed request(s) for the with the requirements of 39 CFR recent Postal Service filing for the Commission to consider matters related 3007.301.1 Commission’s consideration concerning to negotiated service agreement(s). The The Commission invites comments on negotiated service agreements. This request(s) may propose the addition or whether the Postal Service’s request(s) notice informs the public of the filing, removal of a negotiated service invites public comment, and takes other agreement from the market dominant or administrative steps. 1 See Docket No. RM2018–3, Order Adopting the competitive product list, or the Final Rules Relating to Non-Public Information, DATES: Comments are due: September modification of an existing product June 27, 2018, Attachment A at 19–22 (Order No. 24, 2018. currently appearing on the market 4679).

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in the captioned docket(s) are consistent General Counsel Certification: The 50 Moraga Avenue, Presidio of San with the policies of title 39. For General Counsel of the United States Francisco, California. request(s) that the Postal Service states Postal Service has certified that these The purposes of this meeting are to: concern market dominant product(s), meetings may be closed under the Provide the Board Chair’s report; applicable statutory and regulatory Government in the Sunshine Act. provide the Chief Executive Officer’s requirements include 39 U.S.C. 3622, 39 CONTACT PERSON FOR MORE INFORMATION: report; hold a National Environmental U.S.C. 3642, 39 CFR part 3010, and 39 Michael J. Elston, Acting Secretary of Policy Act scoping workshop for the CFR part 3020, subpart B. For request(s) the Board, U.S. Postal Service, 475 Fort Winfield Scott project; and receive that the Postal Service states concern L’Enfant Plaza SW, Washington, DC public comment on these and other competitive product(s), applicable 20260–1000. Telephone: (202) 268– matters pertaining to Trust business. statutory and regulatory requirements 4800. Individuals requiring special include 39 U.S.C. 3632, 39 U.S.C. 3633, accommodation at this meeting, such as 39 U.S.C. 3642, 39 CFR part 3015, and Michael J. Elston, needing a sign language interpreter, 39 CFR part 3020, subpart B. Comment Acting Secretary. should contact Mollie Matull at deadline(s) for each request appear in [FR Doc. 2018–20602 Filed 9–18–18; 4:15 pm] 415.561.5300 prior to October 9, 2018. section II. BILLING CODE 7710–12–P DATES: The meeting will begin at 5:00 II. Docketed Proceeding(s) p.m. on October 18, 2018. 1. Docket No(s).: CP2018–216; Filing POSTAL SERVICE ADDRESSES: The meeting will be held at Title: Notice of the United States Postal the Officers’ Club, 50 Moraga Avenue, Service of Filing Modification Two to a Product Change—Parcel Select Presidio of San Francisco. Global Plus 4 Negotiated Service Negotiated Service Agreement FOR FURTHER INFORMATION CONTACT: Agreement; Filing Acceptance Date: AGENCY: Postal ServiceTM. Nancy J. Koch, General Counsel, the September 14, 2018; Filing Authority: 39 Presidio Trust, 103 Montgomery Street, ACTION: Notice. CFR 3015.5; Public Representative: P.O. Box 29052, San Francisco, Kenneth R. Moeller; Comments Due: SUMMARY: The Postal Service gives California 94129–0052, Telephone: September 24, 2018. notice of filing a request with the Postal 415.561.5300. 2. Docket No(s).: MC2018–221 and Regulatory Commission to add a Dated: September 13, 2018. CP2018–307; Filing Title: USPS Request domestic shipping services contract to Nancy J. Koch, to Add Parcel Select Contract 33 to the list of Negotiated Service Competitive Product List and Notice of General Counsel. Agreements in the Mail Classification [FR Doc. 2018–20492 Filed 9–19–18; 8:45 am] Filing Materials Under Seal; Filing Schedule’s Competitive Products List. Acceptance Date: September 14, 2018; BILLING CODE 4310–4R–P DATES: Filing Authority: 39 U.S.C. 3642, 39 CFR Date of notice required under 39 3020.30 et seq., and 39 CFR 3015.5; U.S.C. 3642(d)(1): September 20, 2018. Public Representative: Kenneth R. FOR FURTHER INFORMATION CONTACT: Moeller; Comments Due: September 24, Elizabeth Reed, 202–268–3179. SECURITIES AND EXCHANGE 2018. SUPPLEMENTARY INFORMATION: The COMMISSION This Notice will be published in the United States Postal Service® hereby Federal Register. gives notice that, pursuant to 39 U.S.C. [Release No. 34–84141; File No. SR–C2– 3642 and 3632(b)(3), on September 14, 2018–020] Stacy L. Ruble, 2018, it filed with the Postal Regulatory Secretary. Commission a Request of the United Self-Regulatory Organizations; Cboe [FR Doc. 2018–20496 Filed 9–19–18; 8:45 am] States Postal Service to Add Parcel C2 Exchange, Inc.; Notice of Filing and BILLING CODE 7710–FW–P Select Contract 33 to Competitive Immediate Effectiveness of a Proposed Product List. Documents are available at Rule Change Relating To Amend Its www.prc.gov, Docket Nos. MC2018–221, Rules Relating to Categories of POSTAL SERVICE CP2018–307. Registration and Respective Qualification Examinations Required Sunshine Act Meetings; Temporary Elizabeth Reed, for Trading Permit Holders (‘‘TPHs’’) Emergency Committee of the Board of Attorney, Corporate and Postal Business Law. and Associated Persons That Engage Governors [FR Doc. 2018–20440 Filed 9–19–18; 8:45 am] in Trading Activities on the Exchange BILLING CODE 7710–12–P TIME AND DATE: Tuesday, September 11, September 14, 2018. 2018, at 8:30 a.m. and Wednesday, Pursuant to Section 19(b)(1) of the September 12, 2018, at 8:30 a.m. Securities Exchange Act of 1934 (the PRESIDIO TRUST PLACE: Washington, DC. ‘‘Act’’),1 and Rule 19b–4 thereunder,2 STATUS: Closed. Notice of Public Meeting notice is hereby given that on September 7, 2018, Cboe C2 Exchange, MATTERS TO BE CONSIDERED: AGENCY: The Presidio Trust. Inc. (the ‘‘Exchange’’ or ‘‘C2’’) filed with Tuesday, September 11, 2018, at 8:30 ACTION: Notice of public meeting. the Securities and Exchange a.m. Commission (the ‘‘Commission’’) the 1. Strategic Items. SUMMARY: In accordance with the proposed rule change as described in 2. Executive Session. Presidio Trust Act, and in accordance Items I and II below, which Items have with the Presidio Trust’s bylaws, notice been prepared by the Exchange. The Wednesday, September 12, at 8:30 a.m. is hereby given that a public meeting of Commission is publishing this notice to 1. Strategic Items. the Presidio Trust Board of Directors 2. Financial Matters. will be held commencing 5:00 p.m. on 1 15 U.S.C. 78s(b)(1). 3. Executive Session. October 18, 2018, at the Officers’ Club, 2 17 CFR 240.19b–4.

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solicit comments on the proposed rule passing the SIE alone will not qualify an Exchange must pass the SIE before their change from interested persons. individual for registration with the registrations can become effective. The Exchange. To be eligible for registration, Exchange proposes to make the I. Self-Regulatory Organization’s an individual must also be associated requirement operative on October 1, Statement of the Terms of Substance of with a firm, pass an appropriate 2018 to coincide with the effective date the Proposed Rule Change qualification examination for a of FINRA’s requirement.4 Cboe C2 Exchange, Inc. (the representative or principal and satisfy The Exchange notes that individuals ‘‘Exchange’’ or ‘‘C2’’) proposes to amend the other requirements relating to the who are registered as of October 1, 2018 its rules relating to categories of registration process. are eligible to maintain their registration and respective qualification The SIE would assess basic product registrations without being subject to examinations required for Trading knowledge; the structure and function any additional requirements. Permit Holders (‘‘TPHs’’) and associated of the securities industry markets, Individuals who had been registered persons that engage in trading activities regulatory agencies and their functions; within the past two years prior to on the Exchange. and regulated and prohibited practices. October 1, 2018, would also be eligible The text of the proposed rule change In particular, the SIE will cover four to maintain those registrations without is also available on the Exchange’s major areas. The first, ‘‘Knowledge of being subject to any additional website (http://www.cboe.com/ Capital Markets,’’ focuses on topics such requirements, provided they register AboutCBOE/ as types of markets and offerings, within two years from the date of their CBOELegalRegulatoryHome.aspx), at broker-dealers and depositories, and last registration. However, with respect the Exchange’s Office of the Secretary, economic cycles. The second, to an individual who is not registered and at the Commission’s Public ‘‘Understanding Products and Their on the effective date of the proposed Reference Room. Risks,’’ covers securities products at a rule change but was registered within II. Self-Regulatory Organization’s high level as well as associated the past two years prior to the effective Statement of the Purpose of, and investment risks. The third, date of the proposed rule change, the Statutory Basis for, the Proposed Rule ‘‘Understanding Trading, Customer individual’s SIE status in the CRD Change Accounts and Prohibited Activities,’’ system would be administratively focuses on accounts, orders, settlement terminated if such individual does not In its filing with the Commission, the and prohibited activities. The final area, register with the Exchange within four Exchange included statements ‘‘Overview of the Regulatory years from the date of the individual’s concerning the purpose of and basis for Framework,’’ encompasses topics such last registration. The Exchange also the proposed rule change and discussed as SROs, registration requirements and notes that consistent with Interpretation any comments it received on the specified conduct rules. It’s anticipated and Policy .04 of Rule 3.4, the Exchange proposed rule change. The text of these that the SIE would include 75 scored will consider waivers of the SIE alone statements may be examined at the questions plus an additional 10 or the SIE and the representative or places specified in Item IV below. The unscored pretest questions. The passing principal-level examination(s) for TPHs Exchange has prepared summaries, set score would be determined through who are seeking registration in a forth in sections A, B, and C below, of methodologies compliant with testing representative- or principal-level the most significant aspects of such industry standards used to develop registration category.5 statements. examinations and set passing standards. Lastly, the Exchange proposes to A. Self-Regulatory Organization’s The restructured program eliminates adopt Interpretation and Policy .08 of Statement of the Purpose of, and duplicative testing of general securities Rule 3.4 to provide individuals who are Statutory Basis for, the Proposed Rule knowledge on the current associated persons of firms and who Change representative-level qualification hold foreign registrations an alternative, examinations by moving such content more flexible, process to obtain an 1. Purpose into the SIE. The SIE will test Exchange representative-level The SEC recently approved a fundamental securities related registration.6 The Exchange believes proposed rule change to restructure the knowledge, including knowledge of FINRA representative-level qualification basic products, the structure and 4 The Exchange notes that the Exchange’s affiliate, 3 function of the securities industry, the Cboe Exchange, Inc. (‘‘Cboe Options’’) is also examination program. The rule change, submitting a similar rule change to require the SIE which will become effective on October regulatory agencies and their functions for representative-level registrations. In that rule 1, 2018, restructures the examination and regulated and prohibited practices, filing, Cboe Options proposes to make clear in Rule program into a more efficient format whereas the revised representative-level 9.3 that persons required to register as a General qualification examinations will test Securities Representative must also pass the SIE. whereby all new representative-level The Exchange notes that Chapter IX of Cboe applicants will be required to take a knowledge relevant to day-to-day Options Rules is incorporated by reference and as general knowledge examination (the activities, responsibilities and job such, the proposed requirement will similarly apply Securities Industry Essentials functions of representatives. The SIE to the Exchange. 5 Pursuant to a Regulatory Services Agreement Examination (‘‘SIE’’)) and a tailored, was developed in consultation with a committee of industry representatives between FINRA and the Exchange, FINRA provides specialized knowledge examination (a the Exchange certain exam waiver services in revised representative-level and representatives of several other responding to exam waiver requests from Exchange qualification examination) for their SROs. Each of the current TPHs. 6 particular registered role. Individuals representative-level examinations As previously noted, Cboe Options is submitting covers general securities knowledge, a similar rule change which includes the proposed are not required to be associated with an language in Rule 3.4.08. Cboe Options also proposes Exchange or any other self-regulatory with the exception of the Research to include such language in a new Interpretation organization (‘‘SRO’’) member to be Analyst (Series 86 and 87) and Policy .02 of Cboe Options Rule 9.3 to make eligible to take the SIE. However, examinations. clear that such requirement also applies to The Exchange proposes to require that representative-level registrations required for persons who do business with the public. Chapter 3 See Securities Exchange Act Release No. 81098 effective October 1, 2018, new IX of Cboe Options Rules is incorporated by (July 7, 2017), 82 FR 32419 (July 13, 2017) (Order applicants seeking to register in a reference and as such, the proposed requirement Approving File No. SR–FINRA–2017–007). representative capacity with the will similarly apply to the Exchange.

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that there is sufficient overlap between structure and function of the securities 19(b)(3)(A) of the Act 12 and Rule 19b– the SIE and these foreign qualification industry markets, regulatory agencies 4(f)(6) thereunder. requirements to permit them to act as and their functions; and regulated and A proposed rule change filed under exemptions to the SIE. As such the prohibited practices. The Exchange also Rule 19b–4(f)(6) normally does not Exchange proposes to provide that notes that the introduction of the SIE become operative for 30 days from the individuals who are in good standing as and expansion of the pool of individuals date of filing. However, Rule 19b– representatives with the Financial who are eligible to take the SIE, has the 4(f)(6)(iii) 13 permits the Commission to Conduct Authority in the United potential of enhancing the pool of designate a shorter time if such action Kingdom or with a Canadian stock prospective securities industry is consistent with the protection of exchange or securities regulator would professionals by introducing them to investors and the public interest. The be exempt from the requirement to pass securities laws, rules and regulations Exchange has asked the Commission to the SIE, and thus would be required and appropriate conduct before they waive the 30-day operative delay so that only to pass a specialized knowledge join the industry in a registered the proposal may become operative on examination to register with the capacity. Lastly, the Exchange notes October 1, 2018 to coincide with the Exchange as a representative. The adopting the SIE requirement is effective date of FINRA’s proposed rule proposed approach would provide consistent with the requirement recently change on which the proposal is individuals with a United Kingdom or adopted by FINRA.11 based.14 The waiver of the operative Canadian qualification more flexibility delay would make the Exchange’s to obtain an Exchange representative- B. Self-Regulatory Organization’s qualification requirements consistent level registration. The Exchange notes Statement on Burden on Competition with those of FINRA. Therefore, the 7 that FINRA has adopted a similar rule. The Exchange does not believe that Commission believes that the waiver of 2. Statutory Basis the proposed rule change will impose the 30-day operative delay is consistent with the protection of investors and the The Exchange believes the proposed any burden on competition that is not necessary or appropriate in furtherance public interest and hereby waives the rule change is consistent with the 30-day operative delay and designates Securities Exchange Act of 1934 (the of the purposes of the Act. The Exchange believes that the proposed the proposal operative on October 1, ‘‘Act’’) and the rules and regulations 2018.15 thereunder applicable to the Exchange rule change, which harmonizes its rules with recent rule changes adopted by At any time within 60 days of the and, in particular, the requirements of filing of the proposed rule change, the 8 FINRA and which is being filed in Section 6(b) of the Act. Specifically, Commission summarily may the Exchange believes the proposed rule conjunction with similar filings by the other national securities exchanges, will temporarily suspend such rule change if change is consistent with the Section it appears to the Commission that such 6(b)(5) 9 requirements that the rules of reduce the regulatory burden placed on market participants engaged in trading action is necessary or appropriate in the an exchange be designed to prevent public interest, for the protection of fraudulent and manipulative acts and activities across different markets. The Exchange believes that the investors, or otherwise in furtherance of practices, to promote just and equitable the purposes of the Act. principles of trade, to foster cooperation harmonization of these registration and coordination with persons engaged requirements across the various markets IV. Solicitation of Comments will reduce burdens on competition by in regulating, clearing, settling, Interested persons are invited to removing impediments to participation processing information with respect to, submit written data, views, and in the national market system and and facilitating transactions in arguments concerning the foregoing, promoting competition among securities, to remove impediments to including whether the proposed rule participants across the multiple national and perfect the mechanism of a free and change is consistent with the Act. securities exchanges. open market and a national market Comments may be submitted by any of system, and, in general, to protect C. Self-Regulatory Organization’s the following methods: investors and the public interest. Statement on Comments on the Electronic Comments Additionally, the Exchange believes the Proposed Rule Change Received From proposed rule change is consistent with Members, Participants, or Others • Use the Commission’s internet the Section 6(b)(5) 10 requirement that comment form (http://www.sec.gov/ the rules of an exchange not be designed The Exchange neither solicited nor rules/sro.shtml); or to permit unfair discrimination between received written comments on the • Send an email to rule-comments@ customers, issuers, brokers, or dealers. proposed rule change. sec.gov. Please include File Number SR– The Exchange believes that the C2–2018–020 on the subject line. proposed rule change will improve the III. Date of Effectiveness of the efficiency of the Exchange’s Proposed Rule Change and Timing for Paper Comments examination requirements, without Commission Action • Send paper comments in triplicate compromising the qualification Because the foregoing proposed rule to Secretary, Securities and Exchange standards, by eliminating duplicative change does not: (i) Significantly affect Commission, 100 F Street NE, testing of general securities knowledge the protection of investors or the public Washington, DC 20549–1090. on examinations. FINRA has indicated interest; (ii) impose any significant All submissions should refer to File that the SIE was developed in an effort burden on competition; and (iii) become Number SR–C2–2018–020. This file to adopt an examination that would operative for 30 days from the date on assess basic product knowledge; the which it was filed, or such shorter time 12 15 U.S.C. 78s(b)(3)(A). as the Commission may designate, it has 13 17 CFR 240.19b–4(f)(6)(iii). 7 See Securities Exchange Act Release No. 81098 14 become effective pursuant to Section See supra note 3. (July 7, 2017), 82 FR 32419 (July 13, 2017) (Order 15 For purposes only of waiving the 30-day Approving File No. SR–FINRA–2017–007). operative delay, the Commission has also 8 15 U.S.C. 78f(b). 11 See Securities Exchange Act Release No. 81098 considered the proposed rule’s impact on 9 15 U.S.C. 78f(b)(5). (July 7, 2017), 82 FR 32419 (July 13, 2017) (Order efficiency, competition, and capital formation. See 10 Id. Approving File No. SR–FINRA–2017–007). 15 U.S.C. 78c(f).

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number should be included on the of 1934 (‘‘Act’’) 1 and Rule 19b–4 SECURITIES AND EXCHANGE subject line if email is used. To help the thereunder,2 a proposed rule change to COMMISSION Commission process and review your modify investments of the First Trust comments more efficiently, please use TCW Unconstrained Plus Bond ETF, the [Release No. 34–84140; File No. SR– only one method. The Commission will shares of which are currently listed and CboeEDGA–2018–015] post all comments on the Commission’s traded on the Exchange pursuant to internet website (http://www.sec.gov/ NYSE Arca Rule 8.600–E. The proposed Self-Regulatory Organizations; Cboe rules/sro.shtml). Copies of the rule change was published for comment EDGA Exchange, Inc.; Notice of Filing submission, all subsequent in the Federal Register on August 1, and Immediate Effectiveness of a amendments, all written statements 2018.3 The Commission has received no Proposed Rule Change To Amend Its with respect to the proposed rule comment letters on the proposed rule Rules Relating to Categories of change that are filed with the change. Registration and Respective Commission, and all written 4 Qualification Examinations Required communications relating to the Section 19(b)(2) of the Act provides for Members That Engage in Trading proposed rule change between the that within 45 days of the publication of Activities on the Exchange Commission and any person, other than notice of the filing of a proposed rule those that may be withheld from the change, or within such longer period up September 14, 2018. public in accordance with the to 90 days as the Commission may Pursuant to Section 19(b)(1) of the provisions of 5 U.S.C. 552, will be designate if it finds such longer period Securities Exchange Act of 1934 (the available for website viewing and to be appropriate and publishes its ‘‘Act’’),1 and Rule 19b–4 thereunder,2 printing in the Commission’s Public reasons for so finding, or as to which the notice is hereby given that on Reference Room, 100 F Street NE, self-regulatory organization consents, September 7, 2018, Cboe EDGA Washington, DC 20549 on official the Commission shall either approve the Exchange, Inc. (the ‘‘Exchange’’ or business days between the hours of proposed rule change, disapprove the ‘‘EDGA’’) filed with the Securities and 10:00 a.m. and 3:00 p.m. Copies of the proposed rule change, or institute Exchange Commission (‘‘Commission’’) filing also will be available for proceedings to determine whether the the proposed rule change as described inspection and copying at the principal proposed rule change should be in Items I and II below, which Items office of the Exchange. All comments disapproved. The 45th day after have been prepared by the Exchange. received will be posted without change. publication of the notice for this The Commission is publishing this Persons submitting comments are proposed rule change is September 15, notice to solicit comments on the cautioned that we do not redact or edit 2018. The Commission is extending this proposed rule change from interested personal identifying information from 45-day time period. persons. comment submissions. You should submit only information that you wish The Commission finds it appropriate I. Self-Regulatory Organization’s to make available publicly. All to designate a longer period within Statement of the Terms of Substance of submissions should refer to File which to take action on the proposed the Proposed Rule Change Number SR–C2–2018–020 and should rule change so that it has sufficient time be submitted on or before October 11, to consider the proposed rule change. The Exchange is proposing to amend 2018. Accordingly, the Commission, pursuant its rules relating to categories of registration and respective qualification to Section 19(b)(2) of the Act,5 For the Commission, by the Division of examinations required for Members that designates October 30, 2018 as the date Trading and Markets, pursuant to delegated engage in trading activities on the authority.16 by which the Commission shall either Exchange. Eduardo A. Aleman, approve or disapprove, or institute Assistant Secretary. proceedings to determine whether to The text of the proposed rule change is available at the Exchange’s website at [FR Doc. 2018–20431 Filed 9–19–18; 8:45 am] disapprove, the proposed rule change (File No. SR–NYSEArca–2018–43). www.markets.cboe.com, at the principal BILLING CODE 8011–01–P office of the Exchange, and at the For the Commission, by the Division of Commission’s Public Reference Room. Trading and Markets, pursuant to delegated SECURITIES AND EXCHANGE authority.6 II. Self-Regulatory Organization’s COMMISSION Eduardo A. Aleman, Statement of the Purpose of, and Statutory Basis for, the Proposed Rule [Release No. 34–84123; File No. SR– Assistant Secretary. Change NYSEArca–2018–43] [FR Doc. 2018–20437 Filed 9–19–18; 8:45 am] Self-Regulatory Organizations; NYSE BILLING CODE 8011–01–P In its filing with the Commission, the Arca, Inc.; Notice of Designation of a Exchange included statements Longer Period for Commission Action concerning the purpose of and basis for on a Proposed Rule Change Regarding the proposed rule change and discussed Investments of the First Trust TCW any comments it received on the Unconstrained Plus Bond ETF proposed rule change. The text of these statements may be examined at the September 14, 2018. places specified in Item IV below. The On July 11, 2018, NYSE Arca, Inc. 1 15 U.S.C. 78s(b)(1). Exchange has prepared summaries, set (‘‘Exchange’’) filed with the Securities 2 17 CFR 240.19b–4. forth in Sections A, B, and C below, of and Exchange Commission 3 See Securities Exchange Act Release No. 83720 the most significant parts of such (‘‘Commission’’), pursuant to Section (July 26, 2018), 83 FR 37560. statements. 19(b)(1) of the Securities Exchange Act 4 15 U.S.C. 78s(b)(2). 5 Id. 1 15 U.S.C. 78s(b)(1). 16 17 CFR 200.30–3(a)(12). 6 17 CFR 200.30–3(a)(31). 2 17 CFR 240.19b–4.

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A. Self-Regulatory Organization’s The restructured program eliminates seeking registration in a representative- Statement of the Purpose of, and duplicative testing of general securities or principal-level registration category.4 Statutory Basis for, the Proposed Rule knowledge on the current Lastly, the Exchange proposes to Change representative-level qualification eliminate references in its rules to alternative foreign examination 1. Purpose examinations by moving such content into the SIE. The SIE will test modules, along with specific references The SEC recently approved a fundamental securities related to the Series 17, 37 and 38 proposed rule change to restructure the knowledge, including knowledge of examinations. Particularly, the FINRA representative-level qualification basic products, the structure and Exchange notes that FINRA recently 3 examination program. The rule change, function of the securities industry, the announced it was eliminating the which will become effective on October regulatory agencies and their functions United Kingdom Securities 1, 2018, restructures the examination and regulated and prohibited practices, Representative and the Canadian program into a more efficient format whereas the revised representative-level Securities Representative registration whereby all new representative-level qualification examinations will test categories, along with the respective applicants will be required to take a knowledge relevant to day-to-day associated exams (i.e., Series 17, Series 5 general knowledge examination (the activities, responsibilities and job 37 and Series 38). FINRA also stated Securities Industry Essentials functions of representatives. The SIE that it intended to provide individuals Examination (‘‘SIE’’)) and a tailored, was developed in consultation with a who are associated persons of firms and specialized knowledge examination (a committee of industry representatives who hold foreign registrations an revised representative-level and representatives of several other alternative, more flexible, process to qualification examination) for their obtain an Exchange representative-level SROs. Each of the current particular registered role. Individuals registration.6 The Exchange believes representative-level examinations are not required to be associated with an that there is sufficient overlap between covers general securities knowledge, Exchange or any other self-regulatory the SIE and foreign qualification with the exception of the Research organization (‘‘SRO’’) member to be requirements to permit them to act as Analyst (Series 86 and 87) eligible to take the SIE. However, exemptions to the SIE. As such, the examinations. passing the SIE alone will not qualify an Exchange proposes to provide that individual for registration with the The Exchange proposes to require that individuals who are in good standing as Exchange. To be eligible for registration, effective October 1, 2018, new representatives with the Financial an individual must also be associated applicants seeking to register in a Conduct Authority in the United with a firm, pass an appropriate representative capacity with the Kingdom or with a Canadian stock qualification examination for a Exchange must pass the SIE exchange or securities regulator would representative or principal and satisfy examination [sic] before their be exempt from the requirement to pass the other requirements relating to the registrations can become effective. The the SIE, and thus would be required registration process. Exchange proposes to make the only to pass a specialized knowledge The SIE would assess basic product requirement operative on October 1, examination to register with the knowledge; the structure and function 2018 to coincide with the effective date Exchange as a representative. The of the securities industry markets, of FINRA’s requirement. proposed approach would provide regulatory agencies and their functions; The Exchange notes that individuals individuals with a United Kingdom or and regulated and prohibited practices. who are registered as of October 1, 2018 Canadian qualification more flexibility to obtain an Exchange representative- In particular, the SIE will cover four are eligible to maintain their level registration. The Exchange notes major areas. The first, ‘‘Knowledge of registrations without being subject to that FINRA has adopted a similar rule.7 Capital Markets,’’ focuses on topics such any additional requirements. as types of markets and offerings, Individuals who had been registered 2. Statutory Basis broker-dealers and depositories, and within the past two years prior to The Exchange believes the proposed economic cycles. The second, October 1, 2018, would also be eligible ‘‘Understanding Products and Their rule change is consistent with the to maintain those registrations without Securities Exchange Act of 1934 (the Risks,’’ covers securities products at a being subject to any additional high level as well as associated ‘‘Act’’) and the rules and regulations requirements, provided they register thereunder applicable to the Exchange investment risks. The third, within two years from the date of their ‘‘Understanding Trading, Customer and, in particular, the requirements of last registration. However, with respect 8 Accounts and Prohibited Activities,’’ Section 6(b) of the Act. Specifically, to an individual who is not registered the Exchange believes the proposed rule focuses on accounts, orders, settlement on the effective date of the proposed and prohibited activities. The final area, change is consistent with the Section rule change but was registered within 9 ‘‘Overview of the Regulatory 6(b)(5) requirements that the rules of the past two years prior to the effective an exchange be designed to prevent Framework,’’ encompasses topics such date of the proposed rule change, the as SROs, registration requirements and fraudulent and manipulative acts and individual’s SIE status in the CRD practices, to promote just and equitable specified conduct rules. It’s anticipated system would be administratively that the SIE would include 75 scored terminated if such individual does not 4 Pursuant to a Regulatory Services Agreement questions plus an additional 10 register with the Exchange within four between FINRA and the Exchange, FINRA provides unscored pretest questions. The passing years from the date of the individual’s the Exchange certain exam waiver services in responding to exam waiver requests from Exchange score would be determined through last registration. The Exchange also methodologies compliant with testing Members. notes that consistent with Interpretation 5 See Securities Exchange Act Release No. 81098 industry standards used to develop and Policy .01(b) of Rule 2.5, the (July 7, 2017), 82 FR 32419 (July 13, 2017) (Order examinations and set passing standards. Exchange will consider waivers of the Approving File No. SR–FINRA–2017–007). 6 SIE alone or the SIE and the Id. 3 7 Id. See Securities Exchange Act Release No. 81098 representative or principal-level (July 7, 2017), 82 FR 32419 (July 13, 2017) (Order 8 15 U.S.C. 78f(b). Approving File No. SR–FINRA–2017–007). examination(s) for Members who are 9 15 U.S.C. 78f(b)(5).

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principles of trade, to foster cooperation will reduce burdens on competition by public interest, for the protection of and coordination with persons engaged removing impediments to participation investors, or otherwise in furtherance of in regulating, clearing, settling, in the national market system and the purposes of the Act. processing information with respect to, promoting competition among and facilitating transactions in participants across the multiple national IV. Solicitation of Comments securities, to remove impediments to securities exchanges. Interested persons are invited to and perfect the mechanism of a free and C. Self-Regulatory Organization’s submit written data, views and open market and a national market Statement on Comments on the arguments concerning the foregoing, system, and, in general, to protect Proposed Rule Change Received From including whether the proposal is investors and the public interest. Members, Participants or Others consistent with the Act. Comments may Additionally, the Exchange believes the The Exchange has neither solicited be submitted by any of the following proposed rule change is consistent with methods: the Section 6(b)(5) 10 requirement that nor received written comments on the the rules of an exchange not be designed proposed rule change. Electronic Comments to permit unfair discrimination between III. Date of Effectiveness of the • Use the Commission’s internet customers, issuers, brokers, or dealers. Proposed Rule Change and Timing for comment form (http://www.sec.gov/ The Exchange believes that the Commission Action proposed rule change will improve the rules/sro.shtml); or Because the foregoing proposed rule efficiency of the Exchange’s • Send an email to rule-comments@ change does not: (i) Significantly affect examination requirements, without sec.gov. Please include File No. SR– the protection of investors or the public compromising the qualification CboeEDGA–2018–015 on the subject interest; (ii) impose any significant standards, by eliminating duplicative line. testing of general securities knowledge burden on competition; and (iii) become on examinations. FINRA has indicated operative for 30 days from the date on Paper Comments that the SIE was developed in an effort which it was filed, or such shorter time as the Commission may designate, it has • Send paper comments in triplicate to adopt an examination that would to Secretary, Securities and Exchange assess basic product knowledge; the become effective pursuant to Section 12 Commission, 100 F Street NE, structure and function of the securities 19(b)(3)(A) of the Act and Rule 19b– Washington, DC 20549–1090. industry markets, regulatory agencies 4(f)(6) thereunder. A proposed rule change filed under and their functions; and regulated and All submissions should refer to File No. Rule 19b–4(f)(6) normally does not prohibited practices. The Exchange also SR–CboeEDGA–2018–015. This file become operative for 30 days from the notes that the introduction of the SIE number should be included on the date of filing. However, Rule 19b– and expansion of the pool of individuals subject line if email is used. To help the 4(f)(6)(iii) 13 permits the Commission to who are eligible to take the SIE, has the Commission process and review your designate a shorter time if such action potential of enhancing the pool of comments more efficiently, please use is consistent with the protection of prospective securities industry only one method. The Commission will investors and the public interest. The professionals by introducing them to post all comments on the Commission’s Exchange has asked the Commission to securities laws, rules and regulations internet website (http://www.sec.gov/ waive the 30-day operative delay so that and appropriate conduct before they the proposal may become operative on rules/sro.shtml). Copies of the join the industry in a registered October 1, 2018 to coincide with the submission, all subsequent capacity. Lastly, the Exchange notes effective date of FINRA’s proposed rule amendments, all written statements adopting the SIE requirement is change on which the proposal is with respect to the proposed rule consistent with the requirement recently based.14 The waiver of the operative change that are filed with the adopted by FINRA.11 delay would make the Exchange’s Commission, and all written B. Self-Regulatory Organization’s qualification requirements consistent communications relating to the Statement on Burden on Competition with those of FINRA at the same time proposed rule change between the Commission and any person, other than The Exchange does not believe that that FINRA does. Therefore, the Commission believes that the waiver of those that may be withheld from the the proposed rule change will impose public in accordance with the any burden on competition that is not the 30-day operative delay is consistent with the protection of investors and the provisions of 5 U.S.C. 552, will be necessary or appropriate in furtherance available for website viewing and of the purposes of the Act. The public interest and hereby waives the 30-day operative delay and designates printing in the Commission’s Public Exchange believes that the proposed Reference Room, 100 F Street NE, rule change, which harmonizes its rules the proposal operative on October 1, 2018.15 Washington, DC 20549, on official with recent rule changes adopted by business days between the hours of FINRA and which is being filed in At any time within 60 days of the filing of the proposed rule change, the 10:00 a.m. and 3:00 p.m. Copies of such conjunction with similar filings by the filing will also be available for other national securities exchanges, will Commission summarily may temporarily suspend such rule change if inspection and copying at the principal reduce the regulatory burden placed on office of the Exchange. All comments market participants engaged in trading it appears to the Commission that such action is necessary or appropriate in the received will be posted without change. activities across different markets. The Persons submitting comments are Exchange believes that the 12 cautioned that we do not redact or edit harmonization of these registration 15 U.S.C. 78s(b)(3)(A). 13 17 CFR 240.19b–4(f)(6)(iii). personal identifying information from requirements across the various markets 14 See supra note 5. comment submissions. You should 15 For purposes only of waiving the 30-day submit only information that you wish 10 Id. operative delay, the Commission has also to make available publicly. All 11 See Securities Exchange Act Release No. 81098 considered the proposed rule’s impact on (July 7, 2017), 82 FR 32419 (July 13, 2017) (Order efficiency, competition, and capital formation. See submissions should refer to File No. Approving File No. SR–FINRA–2017–007). 15 U.S.C. 78c(f). SR–CboeEDGA–2018–015 and should

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be submitted on or before October 11, FOR FURTHER INFORMATION CONTACT: activities. Applicant does not invest in 2018. Rochelle Kauffman Plesset, Senior securities for short-term speculative For the Commission, by the Division of Counsel, at (202) 551–6840, or Nadya B. purposes. Roytblat, Assistant Chief Counsel, at Trading and Markets, pursuant to delegated Applicant’s Legal Analysis authority.16 (202) 551–6825 (Division of Investment Eduardo A. Aleman, Management, Chief Counsel’s Office). 1. Applicant seeks an order under Assistant Secretary. SUPPLEMENTARY INFORMATION: The Section 3(b)(2) of the Act declaring that following is a summary of the it is primarily engaged in a business [FR Doc. 2018–20438 Filed 9–19–18; 8:45 am] other than that of investing, reinvesting, BILLING CODE 8011–01–P application. The complete application may be obtained via the Commission’s owning, holding or trading in securities website by searching for the file and therefore is not an investment SECURITIES AND EXCHANGE number, or applicant using the company as defined in the Act. 2. Section 3(a)(l)(A) of the Act defines COMMISSION Company name box, at http:// www.sec.gov/search/search.htm or by the term ‘‘investment company’’ to [Investment Company Act Release No. calling (202) 551–8090. include an issuer that is or holds itself 33228; File No. 812–14875] out as being engaged primarily, or Applicant’s Representations proposes to engage primarily, in the Exact Sciences Corporation 1. Formed in 1995, Applicant is a business of investing, reinvesting or September 14, 2018. Delaware corporation that is in the trading in securities. Section 3(a)(l)(C) of AGENCY: Securities and Exchange business of developing, clinical testing, the Act further defines an investment Commission (‘‘Commission’’). marketing and commercializing cancer company as an issuer that is engaged or proposes to engage in the business of ACTION: Notice. and pre-cancer screening and diagnostic tests. Applicant currently manufactures investing, reinvesting, owning, holding Notice of application for an order a non-invasive, patient-friendly or trading in securities, and owns or under Section 3(b)(2) of the Investment screening test called Cologuard and proposes to acquire investment Company Act of 1940 (‘‘Act’’). provides it to patients on a prescription- securities having a value in excess of Applicant: Exact Sciences only basis through its clinical 40% of the value of the issuer’s total Corporation. laboratory. Applicant is also currently assets (exclusive of Government Summary of Application: Applicant working on the development of securities and cash items) on an seeks an order under Section 3(b)(2) of additional tests for other types of unconsolidated basis. Section 3(a)(2) of the Act declaring it to be primarily cancers. the Act defines ‘‘investment securities’’ engaged in a business other than that of 2. Applicant states that companies in to include all securities except investing, reinvesting, owning, holding the heathcare sector such as itself Government securities, securities issued or trading in securities. Applicant is in generally need significant liquid capital by employees’ securities companies, the business of producing and to finance their operations and meet and securities issued by majority-owned developing screening and diagnostic high production, commercialization and subsidiaries of the owner which (a) are tests for the early detection and regulatory costs. Such companies often not investment companies and (b) are prevention of certain cancers. spend a significant proportion of their not relying on the exclusions from the Filing Dates: The application was revenues on research and development definition of investment company in filed on January 30, 2018 and amended (‘‘R&D’’) in order to bring a product to Section 3(c)(1) or Section 3(c)(7) of the on June 1, 2018, July 6, 2018 and August market and to bring products through Act. While Applicant states that it does 24, 2018. the Food and Drug Administration’s not hold itself out as being engaged Hearing or Notification of Hearing: An (‘‘FDA’’) approval process. primarily in the business of investing, order granting the requested relief will 3. Applicant states that it currently reinvesting or trading in securities, be issued unless the Commission orders depends on raised capital to finance Applicant states that it consistently a hearing. Interested persons may operations and continued growth but holds investment securities that exceed request a hearing by writing to the ultimately seeks to generate cash from 40% of its total assets on an Commission’s Secretary and serving its operations to support its business. unconsolidated basis (exclusive of applicant with a copy of the request, Applicant states that it has successfully Government securities and cash items). personally or by mail. Hearing requests raised capital to finance its operations Applicant states that it therefore falls should be received by the Commission and commercialization of Cologuard in within the definition of investment by 5:30 p.m. on October 10, 2018 and large part through various public company under Section 3(a)(l)(C) of the should be accompanied by proof of offerings of its debt and equity Act. service on Applicant, in the form of an securities. Applicant seeks to preserve 3. Rule 3a–8 under the Act provides affidavit or, for lawyers, a certificate of its capital and maintain liquidity, an exclusion from the definition of service. Hearing requests should state pending the use of such capital to investment company if, among other the nature of the writer’s interest, the support its business operations, by factors, a company’s R&D expenses are reason for the request, and the issues investing in short-term investment grade a substantial percentage of its total contested. Persons who wish to be and liquid fixed income and money expenses for the last four fiscal quarters notified of a hearing may request market instruments that earn combined. While Applicant believes notification by writing to the competitive market returns and provide that it complies with the conditions of Commission’s Secretary. a low level of credit risk (‘‘Capital Rule 3a–8, Applicant is concerned that ADDRESSES: Secretary, Securities and Preservation Investments’’). Applicant its R&D expenses, while substantial in Exchange Commission, 100 F Street NE, also, to a limited extent, makes strategic absolute terms, may not be substantial Washington, DC 20549–1090. investments in companies that are as a ratio of overall expenses, Applicant, 441 Charmany Drive, complementary to its core business. particularly given the expense increase Madison, Wisconsin 53719. Applicant’s board of directors oversees in connection with the Applicant’s investment practices and commercialization of Cologuard. 16 17 CFR 200.30–3(a)(12). defines the parameters for investment Applicant’s R&D expenses as a ratio of

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total expenses have declined from a opportunities in developing a screening spend more than 1% of his or her time high of 74% of total expenses in 2012 test for colorectal cancer, culminating in on any securities investment activities to approximately 11% of total expenses the development of Cologuard, which on behalf of the Applicant. They, along for year-end 2017 and 12% as of March received FDA approval in 2014. Since with the Applicant’s approximately 31, 2018. Applicant explains that since 2014, Applicant has been engaged in 1,268 full-time employees, are dedicated the FDA’s approval of Cologuard, sales and marketing Cologuard and has to the production and Applicant has devoted more resources begun research and development on commercialization of Cologuard and the to sales and marketing. Although testing related to other types of cancers. development of new cancer screening Applicant’s R&D expenses have Applicant has nine wholly-owned and diagnostic products. generally increased or remained steady subsidiaries, each of which is an d. Nature of Assets. Applicant states overtime, its overall expenses have operating company integrally related to that as of March 31, 2018, Applicant’s disproportionately increased, causing a Applicant’s business. Applicant has investment securities constituted decline in the ratio of R&D expenses to never sold any of its subsidiaries since approximately 79% of its total assets overall expenses. While Applicant inception. (excluding Government securities and expects to increase funding for R&D for b. Public Representations of Policy. cash items) on an unconsolidated basis.2 other products, it also expects to Applicant states it has never made any Furthermore, more than 99% of its increase funding with respect to the public representations that would investment securities consisted of commercialization of Cologuard. Thus, indicate that it is in any business other Capital Preservation Investments. Applicant does not expect its additional than developing and commercializing Applicant’s remaining investment funding for R&D to cause a significant cancer screening technologies. securities consist of a strategic increase in the ratio of R&D funding to Applicant represents that it has never investment in a company whose overall expenses. held and does not now hold itself out business is complementary to the 4. Section 3(b)(2) of the Act provides as an investment company within the Applicant’s business. Applicant that, notwithstanding Section 3(a)(l)(C) meaning of the Act. Applicant states anticipates that its investment securities of the Act, the Commission may issue that all annual reports, web postings, other than Capital Preservation an order declaring an issuer to be press releases and written Investments will not exceed 10% of its primarily engaged in a business other communications issued by Applicant total unconsolidated assets (excluding than that of investing, reinvesting, have related to its business as a cancer Government securities and cash items) owning, holding, or trading in securities screening and diagnostics company. in the future. Applicant uses current directly, through majority-owned Applicant further states that its public assets, including its Capital Preservation subsidiaries, or controlled companies representations make clear that Investments, to finance its continued conducting similar types of businesses. shareholders invest in the Applicant’s R&D program and operations in Applicant requests an order under securities with the expectation of connection with the commercialization Section 3(b)(2) of the Act declaring that realizing gains from Applicant’s of Cologuard. it is primarily engaged in a business development and commercialization of e. Sources of Income and Revenue. other than that of investing, reinvesting, cancer-screening and diagnostic Applicant represents that since its owning, holding or trading in securities, technologies and not from returns on an inception it has had net operating and therefore is not an investment investment portfolio. Applicant’s only losses. It does, however, derive income company as defined in the Act. public representations regarding its from its investment securities. investment securities are those required 5. In determining whether an issuer is Applicant states that, particularly to be disclosed in public filings with the ‘‘primarily engaged’’ in a non- given its commercialization of investment company business under Commission. c. Activities of Officers and Directors. Cologuard, a review of its current Section 3(b)(2) of the Act, the sources of revenues provides a more Commission considers the following Applicant represents that its board of directors and officers devote accurate picture of its operating factors: (a) The company’s historical company status. Applicant states that, development, (b) its public substantially all of their time managing Applicant’s business as a cancer for the year ended December 31, 2017, representations of policy, (c) the Applicant had approximately $266 activities of its officers and directors, (d) screening and diagnostics company. Applicant states that its management million of revenues attributable to the nature of its present assets, and (e) Cologuard. For the three months ended 1 and corporate governance structure is the sources of its present income. March 31, 2018, Cologuard revenues 6. Applicant submits that it satisfies comprised of professionals with were approximately $90.3 million. In the criteria for issuance of an order expertise in technology, science, contrast, Applicant earned $3.9 million under Section 3(b)(2) of the Act because medicine, life science/biotechnology, in net investment income in 2017, and Applicant is primarily engaged in the and government. Applicant states that $3.7 million for the three months ended business of developing, testing, day-to-day management of the Capital March 31, 2018, all derived from Capital marketing and commercializing cancer Preservation Investments is handled by Preservation Investments.3 Applicant and pre-cancer diagnostic screening external asset managers consistent with states that if investment income were tests and not in the business of investment guidelines adopted by the compared to its revenues from investing, reinvesting, owning, holding Applicant’s board of directors on an Cologuard, it would account for less or trading in securities. annual basis. Applicant states that while a. Historical Development. Applicant the board of directors may review than 2%. Applicant states it does not states that since its inception in 1995 it strategic investments in companies that expect its net investment income to has operated in the healthcare sector to are complementary to the Applicant’s exceed 2% of its revenues over the long develop and commercialize cancer and business, these reviews are made for term. pre-cancer screening and diagnostic long-term business, not speculative investment strategies. None of the 2 Applicant states that none of its subsidiaries tests. Applicant has focused its strategic owns investment securities. members of management or the board of 3 Applicant states that it has not, and does not 1 Tonopah Mining Company of Nevada, 26 SEC directors, even when reviewing strategic expect to, earn investment income from its strategic 426, 427 (1947). investments, spends or proposes to investment.

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7. Applicant asserts that its historical March 21, 2018.3 On April 25, 2018, the has received no comments on the development, its public representations Commission extended the time period proposed rule change. This order grants of policy, the activities of its officers within which to approve the proposed approval of the proposed rule change, as and directors, the nature of its assets rule change, disapprove the proposed modified by Amendment No. 3. and its sources of income and revenue, rule change, or institute proceedings to II. The Exchange’s Description of the determine whether to approve or as discussed in the application, Proposal, as Modified by Amendment disapprove the proposed rule change.4 demonstrate that it is engaged primarily No. 3 10 in a business other than that of Also on April 25, 2018, the Exchange investing, reinvesting, owning, holding filed Amendment No. 1 to the proposed The Exchange proposes to list and or trading securities. Applicant thus rule change.5 On May 17, 2018, the trade the Shares under Exchange Rule asserts that it satisfies the criteria for Exchange filed Amendment No. 2 to the 14.11(i), which governs the listing and issuing an order under Section 3(b)(2) of proposed rule change.6 On June 19, trading of Managed Fund Shares. The the Act. 2018, the Commission instituted Funds are a series of, and the Shares proceedings under Section 19(b)(2)(B) of will be offered by, the Trust.11 Precidian Applicant’s Conditions the Act 7 to determine whether to Funds LLC (‘‘Adviser’’) will serve as the Applicant agrees that any order approve or disapprove the proposed investment adviser to the Funds.12 8 granted pursuant to the application will rule change. On August 14, 2018, the A. Description of the ADRPLUS Funds be subject to the following conditions: Exchange filed Amendment No. 3 to the 1. Applicant will continue to allocate proposed rule change.9 The Commission According to the Exchange, each and use its accumulated cash and Fund seeks to provide investment investment securities for bona fide 3 See Securities Exchange Act Release No. 82881 results that correspond generally, before business purposes; and (March 15, 2018), 83 FR 12449. fees and expenses, to the price and yield 4 2. Applicant will refrain from See Securities Exchange Act Release No. 83102, performance of a particular American 83 FR 19126 (May 1, 2018). Depositary Receipt, hedged against investing or trading in securities for 5 Amendment No. 1, which amended and short-term speculative purposes. replaced the proposed rule change in its entirety, is available at: https://www.sec.gov/comments/sr- reported to the Trade Reporting and Compliance For the Commission, by the Division of cboebzx-2018-019/cboebzx2018019-3551361- Engine (‘‘TRACE’’); (j) clarified a criterion regarding Investment Management, under delegated 162325.pdf. when an order to redeem creation units of a Fund authority. 6 Amendment No. 2, which amended and would be deemed received by the distributor; (k) Eduardo A. Aleman, replaced the proposed rule change in its entirety, specified that the Information Circular (as discussed is available at: https://www.sec.gov/comments/sr- herein) will discuss how information regarding the Assistant Secretary. cboebzx-2018-019/cboebzx2018019-3665011- Disclosed Portfolio (as defined in Exchange Rule [FR Doc. 2018–20408 Filed 9–19–18; 8:45 am] 162423.pdf. 14.11(i)(3)(B)) is disseminated; and (l) made other 7 15 U.S.C. 78s(b)(2)(B). non-substantive, technical, and clarifying BILLING CODE 8011–01–P corrections to the proposal. Because Amendment 8 See Securities Exchange Act Release No. 83467, No. 3 clarifies the derivatives in which the Funds 83 FR 29589 (June 25, 2018). may invest, adds specificity to certain requirements, 9 In Amendment No. 3, which amended and made additional representations, and otherwise SECURITIES AND EXCHANGE replaced, in its entirety, the proposed rule change COMMISSION does not materially alter the substance of the as modified by Amendment No. 2, the Exchange: (a) proposed rule change or raise unique or novel Specified that the derivatives in which the Funds regulatory issues under the Act, Amendment No. 3 [Release No. 34–84143; File No. SR– may invest are over-the-counter (‘‘OTC’’) currency is not subject to notice and comment. Amendment swaps; (b) corrected references to, and specified CboeBZX–2018–019] No. 3 to the proposed rule change is available at: with greater particularity, the Exchange https://www.sec.gov/comments/sr-cboebzx-2018- requirements the Funds would not meet; (c) deleted Self-Regulatory Organizations; Cboe 019/cboebzx2018019-4290642-173190.pdf. a representation that the Funds may not meet the 10 BZX Exchange, Inc.; Order Granting requirement of Exchange Rule 14.11(i)(4)(C)(iv)(b) Additional information regarding the Funds, Approval of a Proposed Rule Change, that the aggregate gross notional value of listed the Trust, and the Shares can be found in as Modified by Amendment No. 3, To derivatives based on any single underlying Amendment No. 3 and the Registration Statement. reference asset shall not exceed 30% of the weight See supra note 9 and infra note 11. List and Trade Shares of Eighteen 11 of the portfolio (including gross notional The Trust is registered under the Investment ADRPLUS Funds of the Precidian ETFs exposures); (d) modified a trading halt Company Act of 1940 (‘‘1940 Act’’). See Trust Under Rule 14.11(i), Managed representation to state that the Exchange will also Registration Statement on Form N–1A for the Trust, Fund Shares halt trading in the Shares where a market-wide dated June 14, 2017 (File Nos. 333–171987 and trading halt is declared in the associated Unhedged 811–22524) (‘‘Registration Statement’’). In addition, September 14, 2018. ADR (as defined herein) and that trading in the the Exchange states that the Commission has issued Shares will remain halted until trading in the an order granting certain exemptive relief to the I. Introduction Unhedged ADR resumes; (e) represented that Shares Trust under the 1940 Act. See Investment Company of the Funds would meet and be subject to Act Release No. 32622 (May 2, 2017) (File No. 812– On March 5, 2018, Cboe BZX Exchange Rule 14.11(i)(2)(C); (f) stated that each 14584). Exchange, Inc. (‘‘Exchange’’ or ‘‘BZX’’) Fund expects to invest in excess of 95% of its net 12 The Exchange represents that the Adviser is not assets in the Unhedged ADRs, and each Fund a registered broker-dealer and is not affiliated with filed with the Securities and Exchange expects that the gross notional value of the a broker-dealer. In addition, Adviser personnel who Commission (‘‘Commission’’), pursuant Currency Hedge (as defined herein) would be equal make decisions regarding a Fund’s portfolio are to Section 19(b)(1) of the Securities to the value of the Unhedged ADRs, which would subject to procedures designed to prevent the use Exchange Act of 1934 (‘‘Act’’) 1 and Rule be approximately 50% of the weight of the portfolio and dissemination of material nonpublic 2 (including gross notional exposures); (g) addressed information regarding the Fund’s portfolio. The 19b–4 thereunder, a proposed rule policy concerns related to the Currency Hedge held Exchange states that in the event that (a) the change to list and trade shares by the Funds in excess of the limit as provided in Adviser becomes registered as a broker-dealer or (‘‘Shares’’) of eighteen ADRPLUS Funds the Exchange Rule 14.11(i)(4)(C)(v); (h) modified a newly affiliated with a broker-dealer, or (b) any new of the Precidian ETFs Trust (‘‘Trust’’), representation to state that the Exchange will adviser or sub-adviser is a registered broker-dealer suspend trading and commence delisting or becomes affiliated with a broker-dealer, it will under Exchange Rule 14.11(i) proceedings pursuant to Exchange Rule 14.12 for implement and maintain a fire wall with respect to (‘‘Managed Fund Shares’’). The the Shares if the Unhedged ADR held by a Fund its relevant personnel or such broker-dealer proposed rule change was published for has been suspended from trading or delisted by the affiliate, as applicable, regarding access to comment in the Federal Register on Unhedged ADR’s listing exchange; (i) stated that the information concerning the composition and/or Exchange or Financial Industry Regulatory changes to the portfolio, and will be subject to Authority, Inc. (‘‘FINRA’’), on behalf of the procedures designed to prevent the use and 1 15 U.S.C. 78s(b)(1). Exchange, are able to access, as needed, trade dissemination of material non-public information 2 17 CFR 240.19b–4. information for certain fixed income instruments regarding such portfolio.

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fluctuations in the exchange rate SA/NV ADRPLUS Fund seeks to fluctuations in the exchange rate between the U.S. dollar and the local provide investment results that between the U.S. dollar and the euro. currency of the foreign security correspond generally, before fees and The following chart includes the underlying the American Depositary expenses, to the price and yield underlying company and the Local Receipt (‘‘Local Currency’’). For performance of Anheuser-Busch InBev Currency for each of the Funds. example, the Anheuser-Busch InBev SA/NV (ADR), hedged against

Fund name Underlying company Local currency

Anheuser-Busch InBev SA/NV ADRPLUS Fund ...... Anheuser-Busch InBev SA/NV ...... Euro. AstraZeneca PLC ADRPLUS Fund ...... AstraZeneca PLC ...... British pound. Banco Santander, S.A. ADRPLUS Fund ...... Banco Santander, S.A ...... Euro. BP P.L.C. ADRPLUS Fund ...... BP p.l.c ...... British pound. British American Tobacco p.l.c. ADRPLUS Fund ...... British American Tobacco p.l.c ...... British pound. Diageo plc ADRPLUS Fund ...... Diageo plc ...... British pound. GlaxoSmithKline plc ADRPLUS Fund ...... GlaxoSmithKline plc ...... British pound. HSBC Holdings Plc ADRPLUS Fund ...... HSBC Holdings Plc ...... British pound. Mitsubishi UFJ Financial Group, Inc. ADRPLUS Fund ...... Mitsubishi UFJ Financial Group, Inc ...... Japanese yen. Novartis AG ADRPLUS Fund ...... Novartis AG ...... Swiss franc. Novo Nordisk A/S (B Shares) ADRPLUS Fund ...... Novo Nordisk A/S (B Shares) ...... Danish krone. Royal Dutch Shell plc (Class A) ADRPLUS Fund ...... Royal Dutch Shell plc (Class A) ...... Euro. Royal Dutch Shell plc (Class B) ADRPLUS Fund ...... Royal Dutch Shell plc (Class B) ...... British pound. Sanofi ADRPLUS Fund ...... Sanofi ...... Euro. SAP AG ADRPLUS Fund ...... SAP AG ...... Euro. Total S.A. ADRPLUS Fund ...... Total S.A ...... Euro. Toyota Motor Corporation ADRPLUS Fund ...... Toyota Motor Corporation ...... Japanese yen. Vodafone Group Plc ADRPLUS Fund ...... Vodafone Group Plc ...... British pound.

According to the Exchange, each requirement that the Disclosed Portfolio listing standards for Managed Fund Fund will hold only: (i) Shares of an and the net asset value (‘‘NAV’’) will be Shares (‘‘Generic Listing Standards’’), in American Depositary Receipt made available to all market particular Exchange Rules (‘‘Unhedged ADR’’) listed on a U.S. participants at the same time); 15 and the 14.11(i)(4)(C)(i)(a)(3)–(4) 23 and national securities exchange; (ii) OTC requirements regarding intraday 14.11(i)(4)(C)(v),24 the policy issues that currency swaps that hedge against indicative value,16 suspension of those rules are intended to address are fluctuations in the exchange rate trading or removal,17 trading halts,18 otherwise mitigated by the structure, between the U.S. dollar and the Local disclosure,19 firewalls,20 and holdings, and purpose of the Funds.25 Currency (‘‘Currency Hedge’’); and (iii) surveillance.21 Further, at least 100,000 According to the Exchange, Exchange cash and cash equivalents.13 Shares of each Fund will be outstanding Rule 14.11(i)(4)(C)(i)(a)(3) is intended to The Trust is required to comply with upon the commencement of trading.22 ensure that no single equity security Rule 10A–3 under the Act 14 for the constitutes too concentrated of a initial and continued listing of the B. The Exchange’s Policy Discussion position in a series of Managed Fund Shares of each Fund. In addition, the According to the Exchange, the Funds Shares, and Exchange Rule Exchange represents that the Shares of will provide investors with the 14.11(i)(4)(C)(i)(a)(4) is similarly each Fund will meet and be subject to opportunity to easily eliminate currency intended to diversify the holdings of a all other requirements of the Generic exposure that they may not even realize series of Managed Fund Shares. The Listing Standards, as defined below, and exists with Unhedged ADRs without Exchange believes that these policy other applicable continued listing having to transact in the currency concerns are mitigated as they relate to requirements for Managed Fund Shares derivatives market. The Exchange the Funds because: (i) The Unhedged under Exchange Rule 14.11(i), such as believes that this would confer a ADR will meet the market cap and the listing requirements regarding the significant benefit to investors and the liquidity requirements of Exchange Disclosed Portfolio (including the broader marketplace by adding Rules 14.11(i)(4)(C)(i)(a)(1) and (2); and transparency and simplifying the 13 For purposes of this filing and consistent with process of eliminating risk from an 23 The Exchange represents that the Funds will Exchange Rule 14.11(i)(4)(C)(iii), cash equivalents investor’s portfolio. not meet: (i) The requirement under Exchange Rule are short-term instruments with maturities of less 14.11(i)(4)(C)(i)(a)(3) that the most heavily weighted than three months that include only the following: The Exchange believes that while the component stock shall not exceed 30% of the equity (i) U.S. Government securities, including bills, Funds would not meet the generic weight of the portfolio; and (ii) the requirement notes, and bonds differing as to maturity and rates under Exchange Rule 14.11(i)(4)(C)(i)(a)(4) that the of interest, which are either issued or guaranteed by 15 See Exchange Rules 14.11(i)(4)(A)(ii) and equity portion of the portfolio shall include a the U.S. Treasury or by U.S. Government agencies 14.11(i)(4)(B)(ii). minimum of 13 component stocks. 24 or instrumentalities; (ii) certificates of deposit 16 See Exchange Rule 14.11(i)(4)(B)(i). The Exchange represents that the Funds may issued against funds deposited in a bank or savings not meet the requirement under Exchange Rule 17 See Exchange Rule 14.11(i)(4)(B)(iii). and loan association; (iii) bankers acceptances, 14.11(i)(4)(C)(v) that the aggregate gross notional 18 which are short-term credit instruments used to See Exchange Rule 14.11(i)(4)(B)(iv). The value of OTC derivatives shall not exceed 20% of finance commercial transactions; (iv) repurchase Exchange will also halt trading in a Fund where a the weight of the portfolio (including gross notional agreements and reverse repurchase agreements; (v) market-wide trading halt is declared in the exposures). associated Unhedged ADR and trading in the Fund bank time deposits, which are monies kept on 25 The Exchange represents that each Fund will remain halted until trading in the Unhedged deposit with banks or savings and loan associations expects to invest in excess of 95% of its net assets ADR resumes. for a stated period of time at a fixed rate of interest; in the Unhedged ADRs. Each Fund expects that the 19 (vi) commercial paper, which are short-term See Exchange Rule 14.11(i)(6). gross notional value of the Currency Hedge would unsecured promissory notes; and (vii) money 20 See Exchange Rule 14.11(i)(7). be equal to the value of the Unhedged ADRs, which market funds. 21 See Exchange Rule 14.11(i)(2)(C). would be approximately 50% of the weight of the 14 17 CFR 240.10A–3. 22 See Exchange Rule 14.11(i)(4)(A)(i). portfolio (including gross notional exposures).

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(ii) the intended function of the Funds securities exchange.26 In particular, the website will include the prospectus for is to eliminate currency exposure risk Commission finds that the proposed the applicable Fund and additional for a single security, which means that rule change is consistent with Section information related to NAV and other the Funds are necessarily concentrated. 6(b)(5) of the Act,27 which requires, applicable quantitative information. The Exchange also believes that the among other things, that the Exchange’s The Commission further believes that creation and redemption mechanism rules be designed to prevent fraudulent the proposal to list and trade the Shares will provide a near frictionless arbitrage and manipulative acts and practices, to is reasonably designed to promote fair opportunity that would minimize the promote just and equitable principles of disclosure of information that may be risk of manipulation of either the trade, to remove impediments to and necessary to price the Shares Unhedged ADR or the applicable Fund perfect the mechanism of a free and appropriately and to prevent trading and, thus, mitigate the manipulation open market and a national market when a reasonable degree of concerns that Exchange Rules system, and, in general, to protect transparency cannot be assured. Trading 14.11(i)(4)(C)(i)(a)(3) and (4) were investors and the public interest. in the Shares may be halted for market intended to address. According to the The Commission also finds that the conditions or for reasons that, in the Exchange, the policy issues that proposal to list and trade the Shares on view of the Exchange, make trading inadvisable. The Exchange will also halt Exchange Rule 14.11(i)(4)(C)(v) is the Exchange is consistent with Section 11A(a)(1)(C)(iii) of the Act 28 which sets trading in a Fund where a market-wide intended to address are also mitigated forth Congress’ finding that it is in the trading halt is declared in the associated by the way that the Funds would use public interest and appropriate for the Unhedged ADR, and trading in the Fund OTC currency swaps. The Exchange protection of investors and the will remain halted until trading in the states that the rule is intended to maintenance of fair and orderly markets Unhedged ADR resumes. mitigate concerns regarding the to assure the availability to brokers, In addition, the Exchange represents manipulability of a particular dealers and investors of information that the Adviser is not a registered underlying reference asset or derivatives with respect to quotations for and broker-dealer and is not affiliated with contract and to minimize counterparty transactions in securities. As noted a broker-dealer.29 risk. While the Currency Hedge above, each Fund will comply with the Trading in the Shares will be subject positions taken by the Funds would not requirements for Managed Fund Shares to the Exchange’s surveillance meet the Generic Listing Standards under Exchange Rule 14.11(i) related to procedures, which are adequate to related to OTC derivatives holdings, the Disclosed Portfolio, NAV (including the properly monitor the trading of the Exchange believes that the policy requirement that the Disclosed Portfolio Shares on the Exchange during all concerns about limiting exposure to and the NAV will be made available to trading sessions and to deter and detect potentially manipulable underlying all market participants at the same violations of Exchange rules and the reference assets that the Generic Listing time), and the intraday indicative value. applicable federal securities laws. The Standards are intended to address are The intraday, closing and settlement Exchange represents that trading in the otherwise mitigated by the liquidity in prices of exchange-traded portfolio Shares will be subject to the Exchange’s the underlying spot currency market. assets, which include only Unhedged existing rules governing the trading of The Exchange represents that the Funds ADRs, will be readily available from the equity securities. will attempt to limit counterparty risk in securities exchanges on which such All Unhedged ADRs will be listed on OTC currency swaps by: (i) Entering Unhedged ADRs are traded, automated a U.S. national securities exchange, all into such contracts only with quotation systems, published or other of which are members of the Intermarket counterparties the Advisor believes are public sources, or online information Surveillance Group (‘‘ISG’’) or are creditworthy; (ii) limiting a Fund’s services such as Bloomberg or Reuters. exchanges with which the Exchange has exposure to each counterparty; and (iii) Intraday price quotations on OTC in place a comprehensive surveillance monitoring the creditworthiness of each currency swaps are available from major counterparty and the Fund’s exposure to broker-dealer firms and from third- 29 See supra note 12. The Commission also notes parties, which may provide prices free that that an investment adviser to an open-end fund each counterparty on an ongoing basis. is required to be registered under the Investment The Exchange believes that counterparty with a time delay or in real-time for a Advisers Act of 1940 (‘‘Advisers Act’’). As a result, risk associated with OTC currency paid fee. Price information for cash the Adviser and its related personnel are subject to swaps is further mitigated because the equivalents will be available from major the provisions of Rule 204A–1 under the Advisers Act relating to codes of ethics. This Rule requires currency swaps are settled on a daily market data vendors. Each Fund’s Disclosed Portfolio will be available on investment advisers to adopt a code of ethics that basis and, thus, the counterparty risk for reflects the fiduciary nature of the relationship to any particular swap is limited in two the issuer’s website clients as well as compliance with other applicable (www.precidian.com) free of charge. securities laws. Accordingly, procedures designed ways—first, counterparty credit Information regarding market price and to prevent the communication and misuse of non- exposure is always limited to a 24 hour trading volume of the Shares will be public information by an investment adviser must period and, second, the exposure of the be consistent with Rule 204A–1 under the Advisers continuously available throughout the swap is only to the movement in the Act. In addition, Rule 206(4)–7 under the Advisers day on brokers’ computer screens and Act makes it unlawful for an investment adviser to currencies over that same 24 hour other electronic services. Information provide investment advice to clients unless such period. investment adviser has (i) adopted and regarding the previous day’s closing implemented written policies and procedures III. Discussion and Commission price and trading volume for the Shares reasonably designed to prevent violation, by the Findings will be published daily in the financial investment adviser and its supervised persons, of section of newspapers. Each Fund’s the Advisers Act and the Commission rules adopted After careful review, the Commission thereunder; (ii) implemented, at a minimum, an annual review regarding the adequacy of the finds that the Exchange’s proposal to list 26 In approving this proposed rule change, the policies and procedures established pursuant to and trade the Shares, as modified by Commission has considered the proposed rule’s subparagraph (i) above and the effectiveness of their Amendment No. 3, is consistent with impact on efficiency, competition, and capital implementation; and (iii) designated an individual formation. See 15 U.S.C. 78c(f). the Act and the rules and regulations (who is a supervised person) responsible for 27 15 U.S.C. 78f(b)(5). administering the policies and procedures adopted thereunder applicable to a national 28 15 U.S.C. 78k–1(a)(1)(C)(iii). under subparagraph (i) above.

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sharing agreement.30 The Exchange may (5) The Funds will attempt to limit initial and continued listing of the obtain information regarding trading in counterparty risk in OTC currency Shares of each Fund. the Funds and Unhedged ADRs held by swaps by: (i) Entering into such (10) A minimum of 100,000 Shares for each Fund via the ISG, from other contracts only with counterparties the each Fund will be outstanding at the exchanges that are members or affiliates Advisor believes are creditworthy; (ii) commencement of trading on the of the ISG, or with which the Exchange limiting a Fund’s exposure to each Exchange. has entered into a comprehensive counterparty; and (iii) monitoring the surveillance sharing agreement. creditworthiness of each counterparty In addition, the Exchange represents Additionally, the Exchange or FINRA, and the Fund’s exposure to each that all statements and representations on behalf of the Exchange, are able to counterparty on an ongoing basis. made in this filing regarding the description of the portfolio or reference access, as needed, trade information for (6) Other than Exchange Rules assets, limitations on portfolio holdings certain fixed income instruments 14.11(i)(4)(C)(i)(a)(3)–(4) and or reference assets, dissemination and reported to TRACE. 14.11(i)(4)(C)(v), the Shares of each availability of reference assets and The Exchange represents that it deems Fund will meet and be subject to all intraday indicative values, and the the Shares to be equity securities, thus requirements of the Generic Listing applicability of Exchange listing rules rendering trading in the Shares subject Standards and other applicable specified in this filing shall constitute to the Exchange’s existing rules continued listing requirements for continued listing requirements for the governing the trading of equity Managed Fund Shares under Exchange Funds. In addition, the Trust, on behalf securities. In support of this proposal, Rule 14.11(i), such as the listing of the Funds, has represented to the the Exchange has made the following requirements regarding the Disclosed Exchange that it will advise the representations: Portfolio (including the requirement Exchange of any failure by a Fund or the that the Disclosed Portfolio and NAV (1) The Exchange has appropriate Shares to comply with the continued will be made available to all market rules to facilitate transactions in the listing requirements, and, pursuant to participants at the same time); and the Shares during all trading sessions. its obligations under Section 19(g)(1) of requirements regarding intraday (2) Trading of the Shares through the the Act, the Exchange will surveil for indicative value, suspension of trading Exchange will be subject to the compliance with the continued listing or removal, trading halts, disclosure, Exchange’s surveillance procedures for requirements. If a Fund or the Shares firewalls, and surveillance. derivative products, including Managed are not in compliance with the (7) Prior to the commencement of Fund Shares, and these procedures are applicable listing requirements, the trading, the Exchange will inform its adequate to properly monitor the Exchange will commence delisting members in an Information Circular of trading of the Shares on the Exchange procedures under Exchange Rule 14.12. during all trading sessions and to deter the special characteristics and risks and detect violations of Exchange rules associated with trading the Shares. This approval order is based on all of and the applicable federal securities Specifically, the Information Circular the Exchange’s representations, laws. will discuss the following: (i) The including those set forth above and in (3) Each of the Funds will hold only: procedures for purchases and Amendment No. 3. For the foregoing (i) Shares of an Unhedged ADR listed on redemptions of Shares in Creation Units reasons, the Commission finds that the a U.S. national securities exchange; (ii) (and that Shares are not individually proposed rule change, as modified by OTC currency swaps that hedge against redeemable); (ii) Exchange Rule 3.7, Amendment No. 3, is consistent with which imposes suitability obligations on Section 6(b)(5) of the Act 32 and Section fluctuations in the exchange rate 33 between the U.S. dollar and the Local Exchange members with respect to 11A(a)(1)(C)(iii) of the Act and the Currency; and (iii) cash and cash recommending transactions in the rules and regulations thereunder equivalents. Shares to customers; (iii) how applicable to a national securities exchange.34 (4) The U.S. national securities information regarding the intraday exchanges on which the Unhedged indicative value and Disclosed Portfolio IV. Conclusion ADRs will be listed are members of ISG is disseminated; (iv) the risks involved or are exchanges with which the in trading the Shares during the Pre- It is therefore ordered, pursuant to 35 Exchange has in place a comprehensive Opening and After Hours Trading Section 19(b)(2) of the Act, that the surveillance sharing agreement. The Sessions when an updated intraday proposed rule change (SR–CboeBZX– Exchange may obtain information indicative value will not be calculated 2018–019), as modified by Amendment regarding trading in the Funds and or publicly disseminated; (v) the No. 3, be, and it hereby is, approved. Unhedged ADRs held by each Fund via requirement that members deliver a For the Commission, by the Division of the ISG, from other exchanges that are prospectus to investors purchasing Trading and Markets, pursuant to delegated members or affiliates of the ISG, or with newly issued Shares prior to or authority.36 which the Exchange has entered into a concurrently with the confirmation of a Eduardo A. Aleman, comprehensive surveillance sharing transaction; and (vi) trading Assistant Secretary. agreement. Additionally, the Exchange information. [FR Doc. 2018–20432 Filed 9–19–18; 8:45 am] (8) The Exchange will suspend or FINRA, on behalf of the Exchange, BILLING CODE 8011–01–P are able to access, as needed, trade trading and commence delisting proceedings pursuant to Exchange Rule information for certain fixed income 32 14.12 for a Fund if the Unhedged ADR 15 U.S.C. 78f(b)(5). instruments reported to TRACE. 33 15 U.S.C. 78k–1(a)(1)(C)(iii). held by a Fund has been suspended 34 As noted above, on June 19, 2018, the 30 For a list of the current members and affiliate from trading or delisted by the Commission instituted proceedings to determine members of ISG, see www.isgportal.com. The Unhedged ADR’s listing exchange. whether to approve or disapprove the proposed rule Exchange notes that not all components of the (9) The Trust is required to comply change. No comments were received in connection with that order instituting proceedings. See supra Disclosed Portfolio for a Fund may trade on markets with Rule 10A–3 under the Act 31 for the that are members of ISG or with which the note 7. Exchange has in place a comprehensive 35 15 U.S.C. 78s(b)(2). surveillance sharing agreement. 31 17 CFR 240.10A–3. 36 17 CFR 200.30–3(a)(12).

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SECURITIES AND EXCHANGE the most significant aspects of such industry standards used to develop COMMISSION statements. examinations and set passing standards. The restructured program eliminates [Release No. 34–84142; File No. SR–CBOE– A. Self-Regulatory Organization’s duplicative testing of general securities 2018–064] Statement of the Purpose of, and Statutory Basis for, the Proposed Rule knowledge on the current Self-Regulatory Organizations; Cboe Change representative-level qualification Exchange, Inc.; Notice of Filing and examinations by moving such content Immediate Effectiveness of a Proposed 1. Purpose into the SIE. The SIE will test Rule Change Relating To Amend Its The SEC recently approved a fundamental securities related Rules Relating to Categories of proposed rule change to restructure the knowledge, including knowledge of Registration and Respective FINRA representative-level qualification basic products, the structure and Qualification Examinations Required examination program.3 The rule change, function of the securities industry, the for Trading Permit Holders (‘‘TPHs’’) which will become effective on October regulatory agencies and their functions and Associated Persons That Engage 1, 2018, restructures the examination and regulated and prohibited practices, in Trading Activities on the Exchange program into a more efficient format whereas the revised representative-level whereby all new representative-level qualification examinations will test September 14, 2018. applicants will be required to take a knowledge relevant to day-to-day Pursuant to Section 19(b)(1) of the general knowledge examination (the activities, responsibilities and job Securities Exchange Act of 1934 (the Securities Industry Essentials functions of representatives. The SIE 1 2 ‘‘Act’’), and Rule 19b–4 thereunder, Examination (‘‘SIE’’)) and a tailored, was developed in consultation with a notice is hereby given that on specialized knowledge examination (a committee of industry representatives September 7, 2018, Cboe Exchange, Inc. revised representative-level and representatives of several other (the ‘‘Exchange’’ or ‘‘Cboe Options’’) qualification examination) for their SROs. Each of the current filed with the Securities and Exchange particular registered role. Individuals representative-level examinations Commission (the ‘‘Commission’’) the are not required to be associated with an covers general securities knowledge, proposed rule change as described in Exchange or any other self-regulatory with the exception of the Research Items I and II below, which Items have organization (‘‘SRO’’) member to be Analyst (Series 86 and 87) been prepared by the Exchange. The eligible to take the SIE. However, examinations. Commission is publishing this notice to passing the SIE alone will not qualify an The Exchange proposes to require that solicit comments on the proposed rule individual for registration with the effective October 1, 2018, new change from interested persons. Exchange. To be eligible for registration, applicants seeking to register in a I. Self-Regulatory Organization’s an individual must also be associated representative capacity with the Statement of the Terms of Substance of with a firm, pass an appropriate Exchange must pass the SIE before their the Proposed Rule Change qualification examination for a registrations can become effective. The representative or principal and satisfy Exchange proposes to make the Cboe Exchange, Inc. (the ‘‘Exchange’’ the other requirements relating to the requirement operative on October 1, or ‘‘Cboe Options’’) proposes to amend registration process. 2018 to coincide with the effective date its rules relating to categories of The SIE would assess basic product of FINRA’s requirement. registration and respective qualification knowledge; the structure and function The Exchange notes that individuals examinations required for Trading of the securities industry markets, who are registered as of October 1, 2018 Permit Holders (‘‘TPHs’’) and associated regulatory agencies and their functions; are eligible to maintain their persons that engage in trading activities and regulated and prohibited practices. registrations without being subject to on the Exchange. In particular, the SIE will cover four any additional requirements. The text of the proposed rule change major areas. The first, ‘‘Knowledge of Individuals who had been registered is also available on the Exchange’s Capital Markets,’’ focuses on topics such within the past two years prior to website (http://www.cboe.com/ as types of markets and offerings, October 1, 2018, would also be eligible AboutCBOE/ broker-dealers and depositories, and to maintain those registrations without CBOELegalRegulatoryHome.aspx), at economic cycles. The second, being subject to any additional the Exchange’s Office of the Secretary, ‘‘Understanding Products and Their requirements, provided they register and at the Commission’s Public Risks,’’ covers securities products at a within two years from the date of their Reference Room. high level as well as associated last registration. However, with respect II. Self-Regulatory Organization’s investment risks. The third, to an individual who is not registered Statement of the Purpose of, and ‘‘Understanding Trading, Customer on the effective date of the proposed Statutory Basis for, the Proposed Rule Accounts and Prohibited Activities,’’ rule change but was registered within Change focuses on accounts, orders, settlement the past two years prior to the effective and prohibited activities. The final area, date of the proposed rule change, the In its filing with the Commission, the ‘‘Overview of the Regulatory Exchange included statements individual’s SIE status in the CRD Framework,’’ encompasses topics such system would be administratively concerning the purpose of and basis for as SROs, registration requirements and the proposed rule change and discussed terminated if such individual does not specified conduct rules. It’s anticipated register with the Exchange within four any comments it received on the that the SIE would include 75 scored proposed rule change. The text of these years from the date of the individual’s questions plus an additional 10 last registration. The Exchange also statements may be examined at the unscored pretest questions. The passing places specified in Item IV below. The notes that consistent with Interpretation score would be determined through and Policy .05 of Rule 3.6A, the Exchange has prepared summaries, set methodologies compliant with testing forth in sections A, B, and C below, of Exchange will consider waivers of the SIE alone or the SIE and the 3 See Securities Exchange Act Release No. 81098 1 15 U.S.C. 78s(b)(1). (July 7, 2017), 82 FR 32419 (July 13, 2017) (Order representative or principal-level 2 17 CFR 240.19b–4. Approving File No. SR–FINRA–2017–007). examination(s) for TPHs who are

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seeking registration in a representative- the Section 6(b)(5) 8 requirement that C. Self-Regulatory Organization’s or principal-level registration category.4 the rules of an exchange not be designed Statement on Comments on the Lastly, the Exchange proposes to to permit unfair discrimination between Proposed Rule Change Received From adopt Interpretation and Policy .09 of customers, issuers, brokers, or dealers. Members, Participants, or Others Rule 3.6A and Interpretation and Policy The Exchange believes that the The Exchange neither solicited nor .02 of Rule 9.3 to provide individuals proposed rule change will improve the received written comments on the who are associated persons of firms and proposed rule change. who hold foreign registrations an efficiency of the Exchange’s alternative, more flexible, process to examination requirements, without III. Date of Effectiveness of the obtain an Exchange representative-level compromising the qualification Proposed Rule Change and Timing for registration. The Exchange believes that standards, by eliminating duplicative Commission Action there is sufficient overlap between the testing of general securities knowledge Because the foregoing proposed rule SIE and these foreign qualification on examinations. FINRA has indicated change does not: (i) Significantly affect requirements to permit them to act as that the SIE was developed in an effort the protection of investors or the public exemptions to the SIE. As such the to adopt an examination that would interest; (ii) impose any significant Exchange proposes to provide that assess basic product knowledge; the burden on competition; and (iii) become individuals who are in good standing as structure and function of the securities operative for 30 days from the date on representatives with the Financial industry markets, regulatory agencies which it was filed, or such shorter time Conduct Authority in the United and their functions; and regulated and as the Commission may designate, it has Kingdom or with a Canadian stock prohibited practices. The Exchange also become effective pursuant to Section exchange or securities regulator would notes that the introduction of the SIE 19(b)(3)(A) of the Act 10 and Rule 19b– be exempt from the requirement to pass and expansion of the pool of individuals 4(f)(6) thereunder. the SIE, and thus would be required who are eligible to take the SIE, has the A proposed rule change filed under only to pass a specialized knowledge potential of enhancing the pool of Rule 19b–4(f)(6) normally does not examination to register with the prospective securities industry become operative for 30 days from the Exchange as a representative. The date of filing. However, Rule 19b– professionals by introducing them to 11 proposed approach would provide securities laws, rules and regulations 4(f)(6)(iii) permits the Commission to designate a shorter time if such action individuals with a United Kingdom or and appropriate conduct before they is consistent with the protection of Canadian qualification more flexibility join the industry in a registered to obtain an Exchange representative- investors and the public interest. The capacity. Lastly, the Exchange notes level registration. The Exchange notes Exchange has asked the Commission to adopting the SIE requirement is that FINRA has adopted a similar rule.5 waive the 30-day operative delay so that consistent with the requirement recently the proposal may become operative on 2. Statutory Basis adopted by FINRA.9 October 1, 2018 to coincide with the The Exchange believes the proposed B. Self-Regulatory Organization’s effective date of FINRA’s proposed rule rule change is consistent with the Statement on Burden on Competition change on which the proposal is Securities Exchange Act of 1934 (the based.12 The waiver of the operative ‘‘Act’’) and the rules and regulations The Exchange does not believe that delay would make the Exchange’s thereunder applicable to the Exchange the proposed rule change will impose qualification requirements consistent and, in particular, the requirements of any burden on competition that is not with those of FINRA. Therefore, the Section 6(b) of the Act.6 Specifically, necessary or appropriate in furtherance Commission believes that the waiver of the Exchange believes the proposed rule of the purposes of the Act. The the 30-day operative delay is consistent change is consistent with the Section Exchange believes that the proposed with the protection of investors and the 7 6(b)(5) requirements that the rules of rule change, which harmonizes its rules public interest and hereby waives the 30-day operative delay and designates an exchange be designed to prevent with recent rule changes adopted by the proposal operative on October 1, fraudulent and manipulative acts and FINRA and which is being filed in practices, to promote just and equitable 2018.13 conjunction with similar filings by the principles of trade, to foster cooperation At any time within 60 days of the other national securities exchanges, will and coordination with persons engaged filing of the proposed rule change, the in regulating, clearing, settling, reduce the regulatory burden placed on Commission summarily may processing information with respect to, market participants engaged in trading temporarily suspend such rule change if and facilitating transactions in activities across different markets. The it appears to the Commission that such securities, to remove impediments to Exchange believes that the action is necessary or appropriate in the and perfect the mechanism of a free and harmonization of these registration public interest, for the protection of open market and a national market requirements across the various markets investors, or otherwise in furtherance of system, and, in general, to protect will reduce burdens on competition by the purposes of the Act. investors and the public interest. removing impediments to participation IV. Solicitation of Comments Additionally, the Exchange believes the in the national market system and proposed rule change is consistent with promoting competition among Interested persons are invited to participants across the multiple national submit written data, views, and 4 Pursuant to a Regulatory Services Agreement securities exchanges. arguments concerning the foregoing, between FINRA and Cboe Options, FINRA provides Cboe Options certain exam waiver services in 10 15 U.S.C. 78s(b)(3)(A). responding to exam waiver requests from Cboe 11 17 CFR 240.19b–4(f)(6)(iii). Options TPHs. 12 See supra note 3. 5 See Securities Exchange Act Release No. 81098 13 8 For purposes only of waiving the 30-day (July 7, 2017), 82 FR 32419 (July 13, 2017) (Order Id. operative delay, the Commission has also Approving File No. SR–FINRA–2017–007). 9 See Securities Exchange Act Release No. 81098 considered the proposed rule’s impact on 6 15 U.S.C. 78f(b). (July 7, 2017), 82 FR 32419 (July 13, 2017) (Order efficiency, competition, and capital formation. See 7 15 U.S.C. 78f(b)(5). Approving File No. SR–FINRA–2017–007). 15 U.S.C. 78c(f).

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including whether the proposed rule SECURITIES AND EXCHANGE list of specific Eligible SES Reference change is consistent with the Act. COMMISSION Entities to be cleared by ICC. ICC has Comments may be submitted by any of also represented that clearing of the [Release No. 34–84130; File No. SR–ICC– the following methods: 2018–007] additional EM Contract will not require any changes to ICC’s Risk Management Electronic Comments Self-Regulatory Organizations; ICE Framework or other policies and • Use the Commission’s internet Clear Credit LLC; Order Approving procedures constituting rules within the comment form (http://www.sec.gov/ Proposed Rule Change Relating to the meaning of the Securities Exchange Act rules/sro.shtml); or of 1934 (‘‘Act’’).7 • Clearance of an Additional Credit Send an email to rule-comments@ Default Swap Contract sec.gov. Please include File Number SR– III. Discussion and Commission CBOE–2018–064 on the subject line. September 14, 2018. Findings Section 19(b)(2)(C) of the Act directs Paper Comments I. Introduction the Commission to approve a proposed • Send paper comments in triplicate On June 13, 2018, ICE Clear Credit rule change of a self-regulatory to Secretary, Securities and Exchange LLC (‘‘ICC’’) filed with the Securities organization if it finds that such Commission, 100 F Street NE, and Exchange Commission proposed rule change is consistent with Washington, DC 20549–1090. (‘‘Commission’’), pursuant to Section the requirements of the Act and the All submissions should refer to File 19(b)(1) of the Securities Exchange Act rules and regulations thereunder Number SR–CBOE–2018–064. This file of 1934 1 and Rule 19b–4 thereunder,2 a applicable to such organization.8 number should be included on the proposed rule change to revise the ICC Section 17A(b)(3)(F) of the Act requires, subject line if email is used. To help the Rulebook (the ‘‘Rules’’) 3 to provide for among other things, that the rules of a Commission process and review your the clearance of an additional Standard registered clearing agency be designed comments more efficiently, please use Emerging Market Sovereign CDS to promote the prompt and accurate only one method. The Commission will contract (‘‘EM Contract’’). The proposed clearance and settlement of securities post all comments on the Commission’s rule change was published for comment transactions, assure the safeguarding of 4 internet website (http://www.sec.gov/ in the Federal Register on July 3, 2018. securities and funds which are in the rules/sro.shtml). Copies of the The Commission did not receive custody or control of the clearing agency submission, all subsequent comments regarding the proposed rule for which it is responsible and, in amendments, all written statements change. On August 16, 2018, the general, to protect investors and the with respect to the proposed rule Commission designated a longer period public interest.9 for Commission action on the proposed The Commission finds that the rule change that are filed with the 5 Commission, and all written rule change. For the reasons discussed change is consistent with Section communications relating to the below, the Commission is approving the 17A(b)(3)(F) of the Act 10 and the rules proposed rule change between the proposed rule change. and regulations thereunder applicable to Commission and any person, other than II. Description of the Proposed Rule ICC. The Commission has reviewed the those that may be withheld from the Change terms and conditions of this contract and has determined that it is public in accordance with the The proposed rule change will substantially similar to the other provisions of 5 U.S.C. 552, will be provide the basis for ICC to clear an contracts listed in Subchapter 26D of available for website viewing and additional credit default swap contract. the ICC Rules, all of which ICC printing in the Commission’s Public ICC proposes to amend Subchapter 26D currently clears, the key difference Reference Room, 100 F Street NE, of its Rules to provide for the clearance being that the underlying reference Washington, DC 20549 on official of an additional EM Contract, the obligations will be issuances by the business days between the hours of Lebanese Republic. ICC represents that Lebanese Republic. Moreover, after 10:00 a.m. and 3:00 p.m. Copies of the this additional EM Contract has terms reviewing the Notice and ICC’s Rules, filing also will be available for consistent with the other EM Contracts policies and procedures, the inspection and copying at the principal approved for clearing at ICC and is Commission finds that the additional office of the Exchange. All comments governed by Subchapter 26D of the EM Contract will be cleared pursuant to received will be posted without change. Rules.6 Minor revisions to Subchapter ICC’s existing clearing arrangements and Persons submitting comments are 26D (Standard Emerging Market related financial safeguards, protections cautioned that we do not redact or edit Sovereign (‘‘SES’’) Single Name) are and risk management procedures.11 In personal identifying information from being made to provide for clearing the addition, based on its own experience comment submissions. You should additional EM Contract. Specifically, in and expertise, including a review of submit only information that you wish Rule 26D–102 (Definitions), ‘‘Eligible data on volume, open interest, and the to make available publicly. All SES Reference Entities’’ is modified to number of ICC clearing participants submissions should refer to File include the Lebanese Republic in the Number SR–CBOE–2018–064 and (‘‘CPs’’) that currently trade in the additional EM Contract as well as should be submitted on or before 1 15 U.S.C. 78s(b)(1). October 11, 2018. 2 17 CFR 240.19b–4. certain model parameters for the For the Commission, by the Division of 3 Capitalized terms used herein but not otherwise additional EM Contract, the Trading and Markets, pursuant to delegated defined have the meaning set forth in the ICC Rules. Commission finds that ICC’s rules, 14 Available at https://www.theice.com/publicdocs/ policies, and procedures are reasonably authority. _ _ _ _ clear credit/ICE Clear Credit Rules.pdf. designed to price and measure the Eduardo A. Aleman, 4 Securities Exchange Act Release No. 34–83545 Assistant Secretary. (June 28, 2018), 83 FR 31244 (July 3, 2018) (SR– ICC–2018–007) (‘‘Notice’’). 7 Id. [FR Doc. 2018–20433 Filed 9–19–18; 8:45 am] 5 Securities Exchange Act Release No. 34–83864 8 15 U.S.C. 78s(b)(2)(C). BILLING CODE 8011–01–P (August 16, 2018), 83 FR 42540 (August 22, 2018) 9 15 U.S.C. 78q–1(b)(3)(F). (SR–ICC–2018–007). 10 15 U.S.C. 78q–1. 14 17 CFR 200.30–3(a)(12). 6 Notice, 83 FR at 31245. 11 Notice, 83 FR at 31245.

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potential risk presented by this product, For the Commission, by the Division of position limit for conventional options collect financial resources in proportion Trading and Markets, pursuant to delegated on the following exchange-traded funds 16 to such risk, and liquidate this product authority. (‘‘ETF’’): The Standard and Poor’s in the event of a CP default, all of which Eduardo A. Aleman, Depositary Receipts Trust (‘‘SPY’’), should help ensure ICC’s ability to Assistant Secretary. iShares Russell 2000 ETF (‘‘IWM’’), maintain the financial resources it needs [FR Doc. 2018–20434 Filed 9–19–18; 8:45 am] PowerShares QQQ Trust (‘‘QQQ’’), to provide its critical services and BILLING CODE 8011–01–P iShares MSCI Emerging Markets ETF function as a central counter party, (‘‘EEM’’), iShares China Large-Cap ETF thereby promoting the prompt and (‘‘FXI’’), iShares MSCI EAFE ETF SECURITIES AND EXCHANGE (‘‘EFA’’), iShares MSCI Brazil Capped accurate settlement of EM Contracts and COMMISSION other credit default swap transactions. ETF (‘‘EWZ’’), iShares 20+ Year For the same reasons, the Commission [Release No. 34–84127; File No. SR–FINRA– Treasury Bond Fund ETF (‘‘TLT’’), and iShares MSCI Japan ETF (‘‘EWJ’’). believes that the rule change would help 2018–034] assure the safeguarding of securities or Below is the text of the proposed rule Self-Regulatory Organizations; change. Proposed new language is in funds in the custody or control of ICC, Financial Industry Regulatory and would be consistent with the italics; proposed deletions are in Authority, Inc.; Notice of Filing and brackets. protection of investors and the public Immediate Effectiveness of a Proposed interest. Rule Change To Amend Rule 2360 * * * * * Therefore, the Commission finds that (Options) To Increase Position Limits 2360. Options acceptance of the additional EM on Options on Certain Exchange- (a) No Change. Contract, on the terms and conditions Traded Funds set out in ICC’s Rules, is consistent with September 14, 2018. (b) Requirements the prompt and accurate clearance and Pursuant to Section 19(b)(1) of the (1) through (2) No Change. settlement of securities transactions and Securities Exchange Act of 1934 derivative agreements, contracts, and (‘‘Act’’) 1 and Rule 19b–4 thereunder,2 (3) Position Limits transactions cleared by ICC, the notice is hereby given that on August (A) Stock Options— safeguarding of securities and funds in 31, 2018, Financial Industry Regulatory the custody or control of ICC, and the Authority, Inc. (‘‘FINRA’’) filed with the (i) through (ii) No Change. protection of investors and the public Securities and Exchange Commission (iii) Conventional Equity Options interest, within the meaning of Section (‘‘SEC’’ or ‘‘Commission’’) the proposed a. For purposes of this paragraph (b), 17A(b)(3)(F) of the Act.12 rule change as described in Items I and standardized equity option contracts of II below, which Items have been the put class and call class on the same IV. Conclusion prepared by FINRA. FINRA has side of the market overlying the same designated the proposed rule change as On the basis of the foregoing, the security shall not be aggregated with constituting a ‘‘non-controversial’’ rule Commission finds that the proposed conventional equity option contracts or change under paragraph (f)(6) of Rule rule change is consistent with the FLEX Equity Option contracts overlying 19b–4 under the Act,3 which renders the same security on the same side of requirements of the Act and in the proposal effective upon receipt of particular with the requirements of the market. Conventional equity option this filing by the Commission. The contracts of the put class and call class Section 17A of the Act,13 and the rules Commission is publishing this notice to and regulations thereunder. on the same side of the market overlying solicit comments on the proposed rule the same security shall be subject to a It is therefore ordered pursuant to change from interested persons. position limit of: 14 Section 19(b)(2) of the Act that the I. Self-Regulatory Organization’s 1. through 5. No Change. proposed rule change (SR–ICC–2018– Statement of the Terms of the Substance 007) be, and hereby is, approved.15 6. for selected conventional options of the Proposed Rule Change on exchange-traded funds (‘‘ETF’’), the FINRA is proposing to amend FINRA position limits are listed in the chart Rule 2360 (Options) to increase the below:

Security underlying option Position limit

The DIAMONDS Trust (DIA) ...... 300,000 contracts. The Standard and Poor’s Depositary Receipts Trust (SPY) ...... [900,000]1,800,000 contracts. The iShares Russell 2000 [Index Fund]ETF (IWM) ...... [500,000]1,000,000 contracts. The PowerShares QQQ Trust (QQQ[Q]) ...... [900,000]1,800,000 contracts. The iShares MSCI Emerging Markets [Index Fund]ETF (EEM) ...... [500,000]1,000,000 contracts. iShares China Large-Cap ETF (FXI) ...... 500,000 contracts. iShares MSCI EAFE ETF (EFA) ...... 500,000 contracts. iShares MSCI Brazil Capped ETF (EWZ) ...... 500,000 contracts. iShares 20+ Year Treasury Bond Fund ETF (TLT) ...... 500,000 contracts. iShares MSCI Japan ETF (EWJ) ...... 500,000 contracts.

12 15 U.S.C. 78q–1(b)(3)(F). 15 In approving the proposed rule change, the 16 17 CFR 200.30–3(a)(12). 13 15 U.S.C. 78q–1. Commission considered the proposal’s impact on 1 15 U.S.C. 78s(b)(1). 14 15 U.S.C. 78s(b)(2). efficiency, competition, and capital formation. 15 2 17 CFR 240.19b–4. U.S.C. 78c(f). 3 17 CFR 240.19b–4(f)(6).

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b. No Change. particular equity option is the The proposed rule change would (B) through (D) No Change. applicable position limit for purposes of amend the table provided in Rule (4) through (24) No Change. Rule 2360.6 Rule 2360(b)(3)(A)(iii) 2360(b)(3)(A)(iii)a.6. as follows: (c) No Change. provides that conventional equity • The position limits for options on •••Supplementary Material:—— options are subject to a basic position SPY would be increased from 900,000 limit of 25,000 contracts or a higher tier contracts to 1,800,000 contracts; .01 through .03 No Change. for conventional option contracts on • The position limit for options on * * * * * securities that underlie exchange-traded IWM would be increased from 500,000 options qualifying for such higher tier as II. Self-Regulatory Organization’s contracts to 1,000,000 contracts; determined by the rules of the options • Statement of the Purpose of, and The position limit for options on exchanges. In addition, FINRA lists QQQ would be increased from 900,000 Statutory Basis for, the Proposed Rule position limits for options on securities Change contracts to 1,800,000 contracts; and that have higher position limits— • The position limit for options on In its filing with the Commission, currently, only the ETFs listed in Rule EEM would be increased from 500,000 FINRA included statements concerning 2360(b)(3)(A)(iii)a.6.—that also contracts to 1,000,000 contracts. the purpose of and basis for the generally mirror the options exchange In addition, the proposed rule change proposed rule change and discussed any position limits.7 At this time, FINRA would add to the table provided in Rule comments it received on the proposed proposes to conform to the options 2360(b)(3)(A)(iii)a.6. as follows, with the rule change. The text of these statements exchanges’ recent amendments that effect of each ETF being increased from may be examined at the places specified increased (or in the case of SPY the current position limit of 250,000 in Item IV below. FINRA has prepared decreased from the pilot program) the contracts: summaries, set forth in sections A, B, position limit options on the following • The position limit for options on and C below, of the most significant ETFs: SPY, IWM, QQQ, EEM, FXI, EFA, FXI would be increased to 500,000 aspects of such statements. EWZ, TLT and EWJ.8 contracts; • A. Self-Regulatory Organization’s The position limit for options on 6 See e.g., CBOE Rule 4.11; ISE Rule 412; EFA would be increased to 500,000 Statement of the Purpose of, and NASDAQ PHLX Rule 1001; NYSE American Rule Statutory Basis for, the Proposed Rule 904; NYSE Arca Rule 6.8; MIAX Rule 307; BOX contracts; • Change Rule 3120 and IM–3120–2; Nasdaq Chapter III, The position limit for options on Section 7; BX Chapter III, Section 7; and BZX Rule EWZ would be increased to 500,000 1. Purpose 18.7. contracts; 7 The options exchanges have recently revised the • FINRA Rule 2360(b)(3)(A) imposes a position limit on SPY options to 1,800,000 contracts The position limit for options on position limit on the number of equity after expiration of a pilot program on July 12, 2018 TLT would be increased to 500,000 options contracts in each class on the that eliminated position limits on SPY options. contracts; and FINRA retained its position for conventional • The position limit for options on same side of the market that can be held options on SPY at 900,000 contracts. The proposed or written by a member, a person rule change proposes to increase the position limit EWJ would be increased to 500,000 associated with a member, or a customer on SPY to 1,800,000 consistent with the options contracts.9 or a group of customers acting in exchanges updating the position limit on SPY to In support of the proposed rule 1,800,000 contracts. See Securities Exchange Act change, as noted by Cboe, position concert. Position limits are intended to Release No. 83349 (May 30, 2018), 83 FR 26123 prevent the establishment of options (June 5, 2018) (Notice of Filing and Immediate limits are determined by the option positions that can be used to manipulate Effectiveness of File No. SR–MIAX–2018–11). See exchange’s requirements according to or disrupt the underlying market or also Securities Exchange Act Release No. 83412 the number of outstanding shares and might create incentives to manipulate or (June 12, 2018), 83 FR 28298 (June 18, 2018) (Notice the trading volume of the underlying of Filing and Immediate Effectiveness of File No. 10 disrupt the underlying market so as to SR–PHLX–2018–44); Securities Exchange Act ETF over the past six months. The benefit the options position. In addition, Release No. 83414 (June 12, 2018), 83 FR 28296 ETFs that underlie options subject to the position limits serve to reduce the (June 18, 2018) (Notice of Filing and Immediate proposed rule change are highly liquid, Effectiveness of File No. SR–BOX–2018–22); and are based on a broad set of highly potential for disruption of the options Securities Exchange Act Release No. 83415 (June market itself, especially in illiquid 12, 2018), 83 FR 28274 (June 18, 2018) (Notice of liquid securities and other reference options classes.4 This consideration has Filing and Immediate Effectiveness of File No. SR– assets. The above listed ETFs are listed been balanced by the concern that the CBOE–2018–042); Securities Exchange Act Release on various national securities exchanges No. 83413 (June 12, 2018), 83 FR 28277 (June 18, and meet their listing standards. limits ‘‘not be established at levels that 2018) (Notice of Filing and Immediate Effectiveness are so low as to discourage participation of File No. SR–NYSEArca-2018–44); and Securities FXI tracks the performance of the in the options market by institutions Exchange Act Release No. 83417 (June 12, 2018), 83 FTSE China 50 Index, which is and other investors with substantial FR 28279 (June 18, 2018) (Notice of Filing and composed of the 50 largest Chinese Immediate Effectiveness of File No. SR– stocks.11 EEM tracks the performance of hedging needs or to prevent specialists NYSEAMER–2018–26). and market makers from adequately 8 See note 7 for discussion regarding position meeting their obligations to maintain a limits for options on SPY. See also Securities 18099 (April 25, 2018) (Notice of Filing and 5 Exchange Act Release No. 82770 (February 23, Immediate Effectiveness of File No. SR–NYSEArca- fair and orderly market.’’ 2018–23) and Securities Exchange Act Release No. Rule 2360(b)(3)(A)(i) does not 2018), 83 FR 8907 (March 1, 2018) (Order Granting Accelerated Approval of File No. SR–CBOE–2017– 83065 (April 19, 2018), 83 FR 18093 (April 25, independently establish a position limit 057). See also Securities Exchange Act Release No. 2018) (Notice of Filing and Immediate Effectiveness for standardized equity options. Rather, 82931 (March 22, 2018), 83 FR 13323 (March 28, of File No. SR–NYSEAMER–2018–14). the position limit established by the 2018) (Notice of Filing and Immediate Effectiveness 9 The proposed rule filing would also make certain wording changes to the listing of the names rules of an options exchange for a of File No. SR–MIAX–2018–10); Securities Exchange Act Release No. 82930 (March 22, 2018), of the ETFs and change in two places ‘‘Index Fund’’ 83 FR 13330 (March 28, 2018) (Notice of Filing and to ‘‘ETF’’. The proposed rule filing would also 4 See Securities Exchange Act Release No. 40969 Immediate Effectiveness of File No. SR–BOX–2018– revise the symbol of The PowerShares QQQ Trust (January 22, 1999), 64 FR 4911, 4912–4913 10); Securities Exchange Act Release No. 82932 to ‘‘QQQ.’’ (February 1, 1999) (Order Approving File No. SR– (March 22, 2018), 83 FR 13316 (March 28, 2018) 10 See for example, Cboe Rule 4.11 Interpretations CBOE–98–23) (citing H.R. No. IFC–3, 96th Cong., (Notice of Filing and Immediate Effectiveness of and Policies: .02. 1st Sess. at 189–91 (Comm. Print 1978)). File No. SR–PHLX–2018–24); Securities Exchange 11 See https://www.ishares.com/us/products/ 5 Id. at 4913. Act Release No. 83066 (April 19, 2018), 83 FR 239536/ishares-china-largecap-etf.

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the MSCI Emerging Markets Index, in Europe, Australia and the Far East, EWJ tracks the MSCI Japan Index, which which is composed of approximately excluding the U.S. and Canada.15 EWZ tracks the performance of large and mid- 800 component securities from tracks the performance of the MSCI sized companies in Japan.19 SPY tracks emerging market countries from all over Brazil 25/50 Index, which is composed the performance of the S&P 500® Index, the world.12 IWM tracks the of shares of large and mid-size which is an index of diversified large performance of the Russell 2000 Index, companies in Brazil.16 TLT tracks the cap U.S. companies.20 which is composed of 2,000 small-cap performance of ICE U.S. Treasury 20+ domestic stocks.13 EFA tracks the Year Bond Index, which is composed of In support of this proposal, all trading performance of MSCI EAFE Index, long-term U.S. Treasury bonds.17 QQQ and other statistics, except SPY which which has over 900 component tracks the performance of the Nasdaq- were compiled by FINRA, have been securities.14 The MSCI EAFE Index is 100 Index, which is composed of 100 of compiled by Cboe as of the dates designed to represent the performance the largest domestic and international provided by Cboe and provided in its of large and mid-cap securities across 21 non-financial companies listed on the proposed rule change to increase the developed markets, including countries Nasdaq Stock Market LLC (‘‘Nasdaq’’).18 applicable positions limits: 21

2017 ADV Shares Fund market ETF 2017 ADV (option outstanding cap. (mil. shares) contracts) (mil.) ($mil.)

FXI ...... 15.08 71,944 78.6 $3,343.6 EEM ...... 52.12 287,357 797.4 34,926.1 IWM ...... 27.46 490,070 253.1 35,809.1 EFA ...... 19.42 98,844 1178.4 78,870.3 EWZ ...... 17.08 95,152 159.4 6,023.4 TLT ...... 8.53 80,476 60.0 7,442.4 QQQ ...... 26.25 579,404 351.6 50,359.7 EWJ ...... 6.06 4,715 303.6 16,625.1 SPY ...... 64.63 2,575,153 976.23 240,540.0

FINRA agrees as proposed by Cboe position limits reflecting notional values For example, the PowerShares QQQ that the liquidity in the underlying that are larger than the current position Trust or QQQ is an ETF that tracks the ETFs, and the liquidity in the ETF limits for ETF analogues (EEM and Nasdaq 100 Index or NDX, which is an options support its request to increase EFA). Where there was no approved index composed of 100 of the largest the position limits for the options index analogue, FINRA believes, based non-financial securities listed on the subject to the proposed rule change. As on the liquidity, breadth and depth of Nasdaq Stock Market LLC (‘‘Nasdaq’’). to the underlying ETF shares, the the underlying market, that the index Options on NDX are currently subject to average daily trading volume across all referenced by the ETF would be no position limits but share similar exchanges for the period of January 1 to considered a broad-based index trading characteristics as QQQ. Based July 31, 2017 was: (i) FXI–15.08 million (example FXI and EWJ).22 FINRA on QQQ’s share price of $154.5422 and shares; (ii) EEM–52.12 million shares; believes that if certain position limits NDX’s index level of 6,339.14, (iii) IWM–27.46 million shares; (iv) are appropriate for the options overlying approximately 40 contracts of QQQ EFA–19.42 million shares; (v) EWZ– equals one contract of NDX. Assume the same index, or an analogue to the 17.08 million shares; (vi) TLT–8.53 that options on NDX are subject to the basket of securities that the ETF tracks, million shares; (vii) QQQ– 26.25 million standard position limit of 25,000 shares; (vii) EWJ–6.06 million shares; then those same economically contracts for broad-based index options and (viii) SPY–64.63 million shares. equivalent position limits should be under options exchange rules. Based on In proposing the increased position appropriate for the option overlying the the above comparison of notional limits, FINRA considered the ETF. In addition, the market values, this would result in a position availability of economically equivalent capitalization of the underlying index or limit equivalent to 1,000,000 contracts products and their respective position reference asset is large enough to absorb for QQQ as NDX’s analogue. However, limits. For instance, some of the ETFs any price movements that may be options on NDX are not subject to underlying options subject to this caused by an oversized trade. Also, the position limits and has an average daily proposal are based on broad-based issuer may look to the stocks comprising trading volume of 15,300 contracts. indices that underlie cash-settled the analogous underlying index or Options on QQQ are currently subject to options that are economically reference asset when seeking to create a position limit of 900,000 contracts but equivalent to the ETF options that are additional ETF shares which are part of has a much higher average daily trading the subject of this proposal and have no the creation/redemption process to volume of 579,404 contracts. position limits (NDX and SPX). Other address supply and demand or to Furthermore, NDX currently has a ETFs are based on broad-based indexes mitigate the price movement of the price market capitalization of $17.2 trillion that underlie cash-settled options with of the ETF. and QQQ has a market capitalization of

12 See https://www.ishares.com/us/products/ 17 See https://www.ishares.com/us/products/ 22 FINRA Rule 2360(b)(3)(B) establishes position 239637/ishares-msci-emerging-markets-etf. 239454/. limits for index options by incorporating by 13 See https://www.ishares.com/us/products/ 18 See https://indexes.nasdaqomx.com/Index/ reference the position limit established by the 239710/ishares-russell-2000-etf. Overview/NDX. options exchange on which the option trades. 14 See https://www.ishares.com/us/products/ 19 See https://www.ishares.com/us/products/ Options exchanges establish rules for index options 239623/. 239665/EWJ. based on the characteristic of the underlying index. 15 20 See https://www.msci.com/eafe. See https://us.spdrs.com/en/etf/spdr-sp-500- See, e.g., Cboe Rule 24.4 and MIAX Rule 1804. 16 See https://www.ishares.com/us/products/ etf-SPY. 239612/ishares-msci-brazil-capped-etf. 21 See note 8.

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$50,359.7 million, and the component Russell 2000 index or RUT, which is an has a market capitalization of $5.18 securities of NDX, in aggregate, have index composed of 2,000 small-cap trillion and EEM has a market traded an average of 440 million shares domestic companies in the Russell 2000 capitalization of $34,926.1 million, and per day in 2017, both market index. Options on RUT are currently the component securities of MXEF, in capitalizations being large enough to subject to no position limits but share aggregate, have traded an average of 33.6 absorb any price movement caused by a similar trading characteristics as IWM. billion shares per day in 2017, both large trade in the QQQ. The Based on IWM’s share price of $144.77 large enough to absorb any price Commission has also approved no and RUT’s index level of 1,486.88, movement caused by a large trade in the position limit for options on NDX, approximately 10 contracts of IWM EEM. Therefore, based on the although it has a much lower daily equals one contract of RUT. Assume comparison of average daily trading trading volume than its analogue, the that options on RUT are subject to the volume, FINRA believes it is reasonable QQQ. Therefore, FINRA believes it is standard position limit of 25,000 to increase the position limit for options reasonable to increase the position limit contracts for broad-based index options on EEM from 500,000 to 1,000,000 for options on QQQ from 900,000 to under options exchange rules. Based on contracts. 1,800,000 contracts. the above comparison of notional EFA tracks the performance of the ® ® The SPDR S&P 500 ETF Trust or values, this would result in a position MSCI EAFE Index or MXEA, which has SPY seeks to provide investment results limit equivalent to 250,000 contracts for over 900 component securities designed that, before expenses, correspond options on IWM as RUT’s analogue. to represent the performance of large generally to the price and yield and mid-cap securities across 21 ® However, options on RUT are not performance of the S&P 500 Index or subject to position limits and has an developed markets, including countries SPX, which is an index composed of average daily trading volume of 66,200 in Europe, Australia and the Far East, 500 large-cap U.S. companies. Options contracts. Options on IWM are currently excluding the U.S. and Canada. Below on the SPX have no position limits and subject to a position limit of 500,000 makes the same notional value share similar trading characteristics as contracts but has a much higher average comparison as made above. Based on SPY. Based on SPY’s price of $263.15 daily trading volume of 490,070 EFA’s share price of $69.16 and MXEA’s and SPX’s index level of 2640.87, contracts. The Commission has index level of 1,986.15, approximately approximately 10 contracts of SPY approved no position limit for options 29 contracts of EFA equals one contract 23 equals one contract of SPX. Assume on RUT, although it has a much lower of MXEA. Assume options on MXEA are that options on SPX are subject to the average daily trading volume than its subject to the standard position limit of standard position limit of 25,000 analogue, the IWM. Furthermore, RUT 25,000 contracts for broad-based index contracts for broad-based index options currently has a market capitalization of options under options exchange rules. under options exchange rules. Based on $2.4 trillion and IWM has a market Based on the above comparison of the above comparison of notional capitalization of $35,809.1 million, and notional values, this would result in a values, this would result in a position the component securities of RUT, in position limit economically equivalent limit equivalent to 250,000 contracts for aggregate, have traded an average of 270 to 721,000 contracts for EFA as MXEA’s options on SPY as SPX’s analogue. million shares per day in 2017, both analogue. Furthermore, MXEA currently However, options on SPX are not large enough to absorb any price has a market capitalization of $18.7 subject to position limits and has an movement caused by a large trade in the trillion and EFA has a market capitalization of $78,870.3 million, and average daily trading volume of IWM. Therefore, FINRA believes it is 1,101,185 contracts.24 Options on SPY the component securities of MXEA, in reasonable to increase the position limit were recently changed to a position aggregate, have traded an average of 4.6 for options on IWM from 500,000 to limit of 1,800,000 contracts for billion shares per day in 2017, both 1,000,000 contracts. standardized options, but is currently large enough to absorb any price subject to a conventional option EEM tracks the performance of the movement caused by a large trade in position limit of 900,000 contracts but MSCI Emerging Markets Index or MXEF, EFA. However, MXEA has an average has a much higher average daily trading which is composed of approximately daily trading volume of 270 contracts. volume of 2,575,153 contracts.25 800 component securities from Options on EFA is currently subject to Furthermore, as of December 29, 2017, emerging market countries from all over a position limit of 250,000 contracts but SPX had a market capitalization of $23.9 the world. Below makes the same has a much higher average daily trading trillion and SPY has a market notional value comparisons as made volume of 98,844 contracts. Based on capitalization of $277.54 billion, large above. Based on EEM’s share price of the above comparisons, FINRA believes enough to absorb any price movement $47.06 and MXEF’s index level of it is reasonable to increase the position caused by a large trade in the SPY. The 1,136.45, approximately 24 contracts of limit for options on EFA from 250,000 Commission has also approved no EEM equals one contract of MXEF. to 500,000 contracts. position limit for options on SPX, Assume that options on MXEF are FXI tracks the performance of the although it has a much lower daily subject to the standard position limit of FTSE China 50 Index, which is trading volume than its analogue, the 25,000 contracts for broad-based index composed of the 50 largest Chinese SPY, for which the exchanges recently options under options exchange rules. stocks. There is currently no index changed the position limit to 1,800,000 Based on the above comparison of analogue for FXI approved for options contracts. Therefore, FINRA believes it notional values, this would result in a trading. Options on FXI are currently is reasonable to increase the position position limit economically equivalent subject to a position limit of 250,000 limits for options on SPY from 900,000 to 604,000 contracts for options on EEM contracts but has a much higher average to 1,800,000 contracts. as MXEF’s analogue. However, MXEF daily trading volume of 15.08 million The iShares Russell 2000 ETF or has an average daily trading volume of shares. However, the FTSE China 50 IWM, is an ETF that also tracks the 180 contracts. Options on EEM is Index currently has a market currently subject to a position limit of capitalization of $1.7 trillion and FXI 23 As of March 29, 2018. 500,000 contracts but has a much higher has a market capitalization of $2,623.18 24 As of July 31, 2017. average daily trading volume of 287,357 million, both large enough to absorb any 25 See note 7. contracts. Furthermore, MXEF currently price movement caused by a large trade

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in FXI. The components of the FTSE subject to a position limit of 250,000 members to the extent of any margin China 50 Index, in aggregate, have an contracts and has an average daily deficiency resulting from the higher average daily trading volume of 2.3 trading volume of 6.6 million shares. margin requirement. billion shares. Based on the above Based on the above comparisons, FINRA FINRA has filed the proposed rule comparisons, FINRA believes it is believes it is reasonable to increase the change for immediate effectiveness and reasonable to increase the position limit position limit for options on EWJ from has requested that the SEC waive the for options on FXI from 250,000 to 250,000 to 500,000 contracts. requirement that the proposed rule 500,000 contracts. FINRA believes that increasing the change not become operative for 30 days EWZ tracks the performance of the position limits for the conventional after the date of the filing, so FINRA can MSCI Brazil 25/50 Index, which is options subject to the proposed rule implement the proposed rule change composed of shares of large and mid- change would lead to a more liquid and immediately. size companies in Brazil. There is competitive market environment for currently no index analogue for EWZ these options, which will benefit 2. Statutory Basis approved for options trading. Options customers interested in these products. FINRA believes that the proposed rule on EWZ are currently subject to a Surveillance and Reporting change is consistent with the provisions position limit of 250,000 contracts but of Section 15A(b)(6) of the Act,30 which the ETF has a much higher average daily Further, FINRA believes that the increased position limits provisions are requires, among other things, that trading volume of 17.08 million shares. FINRA rules must be designed to However, the MSCI Brazil 25/50 Index appropriate in light of the existing surveillance procedures and reporting prevent fraudulent and manipulative currently has a market capitalization of acts and practices, to promote just and $700 billion and EWZ has a market requirements at FINRA,26 the options exchanges, and at the several clearing equitable principles of trade, and, in capitalization of $6,023.4 million, both general, to protect investors and the large enough to absorb any price firms, which are capable of properly public interest. FINRA believes that the movement caused by a large trade in identifying unusual or illegal trading proposed rule change promotes EWZ. The components of the MSCI activity. These procedures use daily consistent regulation by harmonizing Brazil 25/50 Index, in aggregate, have an monitoring of market movements by position limits with those of the other average daily trading volume of 285 automated surveillance techniques to self-regulatory organizations. FINRA million shares. Based on the above identify unusual activity in both options 27 further believes that increasing the comparisons, FINRA believes it is and underlying stocks. position limit on conventional options reasonable to increase the position limit In addition, large stock holdings must promotes consistent regulation by for options on EWZ from 250,000 to be disclosed to the Commission by way 28 harmonizing the position limit with its 500,000 contracts. of Schedules 13D or 13G. Options TLT tracks the performance of the ICE positions are part of any reportable standardized counterpart. In addition, U.S. Treasury 20+ Year Bond Index, positions and cannot legally be hidden. FINRA believes the proposed rule which is composed of long-term U.S. Moreover, the previously noted Rule change will be beneficial to large market Treasury bonds. There is currently no 2360(b)(5) requirement that members makers and institutions (which index analogue for TLT approved for must file reports with FINRA for any generally have the greatest ability to options trading. However, the U.S. customer that held aggregate large long provide liquidity and depth in products Treasury market is one of the largest and or short positions of any single class for that may be subject to higher position most liquid markets in the world, with the previous day will continue to serve limits as has been the case with recently over $14 trillion outstanding and as an important part of FINRA’s approved increased position limits),31 turnover of approximately $500 billion surveillance efforts. as well as retail traders and public per day. TLT currently has a market Finally, FINRA believes that the customers, by providing them with a capitalization of $7,442.4 million, both current financial requirements imposed more effective trading and hedging large enough to absorb any price by FINRA and by the Commission vehicle. In addition, FINRA believes movement caused by a large trade in adequately address financial that the structure of the options subject TLT. Therefore, any potential for responsibility concerns that a member to the proposed rule change and the manipulation will not increase solely or its customer will maintain an considerable liquidity of the market for due to the increase in position limits as inordinately large unhedged position in those options diminishes the set forth in this proposal. Based on the any option with a higher position limit. opportunity to manipulate these above comparisons, FINRA believes it is Current margin and risk-based haircut products and disrupt the underlying reasonable to increase the position limit methodologies serve to limit the size of market that a lower position limit may for options on TLT from 250,000 to positions maintained by any one protect against. 500,000 contracts. account by increasing the margin or Increased position limits for select EWJ tracks the MSCI Japan Index, capital that a member must maintain for actively traded options, such as those which tracks the performance of large a large position. Under Rule proposed herein, is not novel and has and mid-sized companies in Japan. 4210(f)(8)(A), FINRA also may impose a been previously approved by the There is currently no index analogue for higher margin requirement upon a Commission. For example, the EWJ approved for options trading. member when FINRA determines a Commission has previously approved a However, the MSCI Japan Index has a higher requirement is warranted. In position limit of 1,800,000 contracts on market capitalization of $3.5 trillion and addition, the Commission’s net capital options on SPY.32 Additionally, the EWJ has a market capitalization of rule 29 imposes a capital charge on Commission has approved similar $16,625.1 million, and the component proposed rule changes by the options securities of the MSCI Japan Index, in 26 See Rule 2360(b)(5) for the options reporting exchanges to increase position and aggregate, have traded an average of 1.1 requirements. exercise limits for options on highly 27 These procedures have been effective for the billion shares per day in 2017, both surveillance of options trading and will continue to large enough to absorb any price be employed. 30 15 U.S.C. 78o–3(b)(6). movement caused by a large trade in 28 17 CFR 240.13d–1. 31 See note 8. EWJ. Options on EWJ is currently 29 17 CFR 240.15c3–1. 32 See note 7.

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liquid, actively-traded ETFs,33 shares to the ETF provider. In exchange, Economic Impact Analysis including a proposal to permanently the ETF provider gives the Authorized FINRA has undertaken an economic eliminate the position and exercise Participant a block of equally valued impact assessment, as set forth below, to limits for options overlaying the S&P ETF shares, on a one-for-one fair value analyze the potential economic impacts, 500 Index, S&P 100 Index, Dow Jones basis. The price is based on the net asset including anticipated costs, benefits, Industrial Average, and Nasdaq 100 value, not the market value at which the 34 and distributional and competitive Index. In approving the permanent ETF is trading. The creation of new ETF effects transfers of wealth, relative to the elimination of position and exercise units can be conducted all trading day current baseline, and the alternatives limits, the Commission relied heavily and is not subject to position limits. FINRA considered in assessing how to upon surveillance capabilities, and the This process can also work in reverse best meet its regulatory objectives. Commission expressed trust in the where the ETF company seeks to enhanced surveillance and reporting decrease the number of shares that are Regulatory Objective safeguards in order to detect and deter available to trade. The creation and FINRA is proposing to amend Rule possible manipulative behavior, which redemption process, therefore, creates a 2360 to harmonize FINRA’s position might arise from eliminating position direct link to the underlying limits for conventional options with the 35 and exercise limits. Furthermore, as components of the ETF, and serves to position limit for standardized described more fully above, options on mitigate potential price impact of the options.37 other ETFs have the position limits ETF shares that might otherwise result proposed herein, but their trading from increased position limits. Economic Baseline volumes are significantly lower than the Per FINRA Rule 2360(b)(30)(A)(iii) ETFs subject to the proposed rule The ETF creation and redemption process keeps ETF share prices trading conventional equity options are subject change. to a basic position limit of 25,000 Furthermore, the proposed position in line with the ETF’s underlying net asset value. Because an ETF trades like contracts or higher for conventional limits would continue to address option contracts on securities that potential manipulative activity while a stock, its price will fluctuate during the trading day, due to simple supply underlie exchange-traded options allowing for potential hedging activity qualifying for a higher tier as for appropriate economic purposes. The and demand. If demand to buy an ETF is high, for instance, the ETF’s share determined by option exchange rules. creation and redemption process for The existing position limits for these ETFs also lessens the potential for price might rise above the value of its conventional options on ETFs are: manipulative activity. When an ETF underlying securities. When this 900,000 contracts for SPY or QQQ, company wants to create more ETF happens, an Authorized Participant can 500,000 contracts for IWM or EEM, and shares, it looks to an Authorized arbitrage this difference by buying the 250,000 contracts for FXI, EFA, EWZ, Participant, which is a market maker or underlying shares that compose the ETF TLT, or EWJ. Option exchanges have other large financial institution, to and then selling the ETF shares on the recently increased (or in the case of SPY acquire the securities the ETF is to hold. open market. This drives the ETF’s decreased from the pilot program) For instance, IWM is designed to track share price back toward fair value. position limit options on several ETFs the performance of the Russell 2000 Likewise, if the ETF starts trading at a such as SPY, IWM, QQQ, EEM, FXI, Index. The Authorized Participant will discount to the securities it holds, the purchase all the Russell 2000 Authorized Participant can buy shares EFA, EWZ, TLT, and EWJ. constituent securities in the exact same of the ETF and redeem them for the Economic Impact weight as the index, then deliver those underlying securities. Buying Benefits undervalued ETF shares drives the price 33 See Securities Exchange Act Release No. 68086 of the ETF back toward fair value. This As noted above, the proposed rule (October 23, 2012), 77 FR 65600 (October 29, 2012) arbitrage process helps to keep an ETF’s change would amend Rule 2360 to (Order Approving File No. SR–CBOE–2012–66); harmonize FINRA’s position limits for Securities Exchange Act Release No. 68478 price in line with the value of its (December 19, 2012), 77 FR 76132 (December 26, underlying portfolio. conventional options with the position 38 2012) (Notice of Filing and Immediate Effectiveness Lastly, the Commission expressed the limit for standardized options. For of File No. SR–BOX–2012–23); Securities Exchange belief that removing position and investors that short conventional equity Act Release No. 68398 (December 11, 2012), 77 FR options or buy them long, there is likely 74700 (December 17, 2012) (Notice of Filing and exercise limits may bring additional Immediate Effectiveness of File No. SR–ISE–2012– depth and liquidity without increasing to be a natural size for an executed order 93); Securities Exchange Act Release No. 68293 that minimizes fixed and variable (November 27, 2012), 77 FR 71644 (December 3, concerns regarding intermarket manipulation or disruption of the transaction costs, including but not 2012) (Notice of Filing and Immediate Effectiveness limited to the bid-ask spread, price of File No. SR–Phlx–2012–132); Securities options or the underlying securities.36 Exchange Act Release No. 68358 (December 5, FINRA’s existing surveillance and impact, and transaction fees. If the 2012), 77 FR 73708 (December 11, 2012) (Notice of existing position limits for conventional Filing and Immediate Effectiveness of File No. SR– reporting safeguards are designed to deter and detect possible manipulative equity options on select ETFs constrains NYSE MKT–2012–71); Securities Exchange Act the order size such that fixed and Release No. 68359 (December 5, 2012), 77 FR 73716 behavior, which might arise from (December 11, 2012) (Notice of Filing and eliminating position and exercise limits. variable transaction costs are higher Immediate Effectiveness of File No. SR–NYSE than optimal, then investors may benefit Arca–2012–132) and Securities Exchange Act B. Self-Regulatory Organization’s if the new position limit is no less than Release No. 69457 (April 25, 2013), 78 FR 25502 Statement on Burden on Competition the natural size. In such an event, the (May 1, 2013) (Notice of Filing and Immediate Effectiveness of File No. SR–MIAX–2013–17). cost to hedge an ETF would decline, 34 See Securities Exchange Act Release No. 44994 FINRA does not believe that the thereby making it less costly to manage (October 26, 2001), 66 FR 55722 (November 2, 2001) proposed rule change will result in any downside risk. (Order Approving File No. SR–CBOE–2001–22) and burden on competition that is not In addition, if the existing position Securities Exchange Act Release No. 52650 (October necessary or appropriate in furtherance 21, 2005), 70 FR 62147 (October 28, 2005) (Order limits serve as a constraint, then an Approving File No. SR–CBOE–2005–41) (‘‘NDX of the purposes of the Act. Approval’’). 37 See note 8. 35 See NDX Approval at 62149. 36 See NDX Approval at 62149. 38 See note 8.

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increase in the position limit for Alternatives IV. Solicitation of Comments conventional options on select ETFs would permit investors to more easily No further alternatives are under Interested persons are invited to find a counterparty. If the number of consideration. submit written data, views, and counterparties increases, then the cost C. Self-Regulatory Organization’s arguments concerning the foregoing, of hedging should decline as the half- Statement on Comments on the including whether the proposed rule spread narrows, thereby making it less Proposed Rule Change Received From change is consistent with the Act. expensive to manage downside risk. Members, Participants, or Others Comments may be submitted by any of The extent of the constraint imposed the following methods: by the current limit on conventional Written comments were neither options is related to the ability of an solicited nor received. Electronic Comments investor to achieve similar economic • Use the Commission’s internet exposure through other means. If there III. Date of Effectiveness of the comment form (http://www.sec.gov/ are other securities, such as an option Proposed Rule Change and Timing for on a closely related index, that exist and Commission Action rules/sro.shtml); or • provide similar economic exposure less Because the foregoing proposed rule Send an email to rule-comments@ expensively, then the value of lessening change does not: (i) Significantly affect sec.gov. Please include File Number SR– the position limit on conventional the protection of investors or the public FINRA–2018–034 on the subject line. options on ETFs is lower. Members may interest; (ii) impose any significant Paper Comments rely on information and data feeds from burden on competition; and (iii) become the Options Clearing Corporation to operative for 30 days after the date of • Send paper comments in triplicate assist in their monitoring position the filing, or such shorter time as the to Secretary, Securities and Exchange limits. Because position limits on the Commission may designate if consistent Commission, 100 F Street NE, standardized and conventional side with the protection of investors and the Washington, DC 20549–1090. have traditionally been consistent, public interest, it has become effective members have relied on this feed for pursuant to Section 19(b)(3)(A) of the All submissions should refer to File both standardized and conventional Act 39 and Rule 19b–4(f)(6) 40 Number SR–FINRA–2018–034. This file options. If the position limits between thereunder. number should be included on the standardized and conventional options subject line if email is used. To help the are conformed, then the cost from FINRA has asked the Commission to Commission process and review your waive the 30-day operative delay so that monitoring position limits should comments more efficiently, please use FINRA may immediately harmonize decline for member firms. only one method. The Commission will position limits with those of other self- Cost regulatory organizations to ensure post all comments on the Commission’s The proposed rule change may consistent regulation. For this reason, internet website (http://www.sec.gov/ impose limited operational cost on the Commission believes that waiving rules/sro.shtml). Copies of the member firms that trade conventional the 30-day operative delay is consistent submission, all subsequent options on ETFs, as these same firms with the protection of investors and the amendments, all written statements would need to revise position limits that public interest. Therefore, the with respect to the proposed rule are used in trading systems. However, Commission hereby waives the change that are filed with the the proposed rule change should not operative delay and designates the Commission, and all written impose additional costs, because it is proposal operative upon filing.41 communications relating to the difficult to disrupt or manipulate the At any time within 60 days of the proposed rule change between the underlying market, create an incentive filing of the proposed rule change, the Commission and any person, other than to disrupt or manipulate the underlying Commission summarily may those that may be withheld from the market for the purpose of profiting from temporarily suspend such rule change if public in accordance with the the options position, or disrupt or it appears to the Commission that such provisions of 5 U.S.C. 552, will be manipulate the options market for action is necessary or appropriate in the available for website viewing and conventional options on ETFs affected public interest, for the protection of printing in the Commission’s Public by this proposed rule. ETFs that investors, or otherwise in furtherance of Reference Room, 100 F Street NE, underlie options subject to the proposed the purposes of the Act. If the Washington, DC 20549 on official rule change are highly liquid, and are Commission takes such action, the business days between the hours of based on a broad set of highly liquid Commission shall institute proceedings 10:00 a.m. and 3:00 p.m. Copies of such securities, which makes the market to determine whether the proposed rule filing also will be available for difficult to manipulate or disrupt. In should be approved or disapproved. fact, options on certain broad-based inspection and copying at the principal security indexes have no position limits. office of FINRA. All comments received 39 Furthermore, the creation and 15 U.S.C. 78s(b)(3)(A). will be posted without change. Persons 40 17 CFR 240.19b–4(f)(6). In addition, Rule 19b– submitting comments are cautioned that redemption process for these ETFs 4(f)(6)(iii) requires a self-regulatory organization to reduces the potential for disruptive or give the Commission written notice of its intent to we do not redact or edit personal manipulative activity. New ETF units file the proposed rule change, along with a brief identifying information from comment may be created at any time during the description and the text of the proposed rule submissions. You should submit only change, at least five business days prior to the date information that you wish to make trading day and are not subject to of filing of the proposed rule change, or such position limits. Consequently, there is a shorter time as designated by the Commission. available publicly. All submissions direct link between the underlying FINRA has satisfied this requirement. should refer to File Number SR–FINRA– components of the ETF and the ETF, 41 For purposes only of waiving the 30-day 2018–034, and should be submitted on operative delay, the Commission has also or before October 11, 2018. which keeps ETF share prices trading in considered the proposed rule’s impact on line with the ETF’s underlying net asset efficiency, competition, and capital formation. See value. 15 U.S.C. 78c(f). 42 17 CFR 200.30–3(a)(12).

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For the Commission, by the Division of Percent Advisory Committee Act (5 U.S.C., Trading and Markets, pursuant to delegated Appendix 2), SBA announces the authority.42 For Economic Injury: meeting of the AFMAC. The AFMAC is Eduardo A. Aleman, Non-Profit Organizations with- tasked with providing recommendation Assistant Secretary. out Credit Available Else- and advice regarding the Agency’s where ...... 2.500 [FR Doc. 2018–20435 Filed 9–19–18; 8:45 am] financial management, including the BILLING CODE 8011–01–P financial reporting process, systems of The number assigned to this disaster internal controls, and audit process and for physical damage is 156906 and for process for monitoring compliance with economic injury is 156910. SMALL BUSINESS ADMINISTRATION relevant law and regulations. (Catalog of Federal Domestic Assistance The purpose of the meeting is to [Disaster Declaration #15690 and #15691; Number 59008) discuss the SBA’s Financial Reporting, ALASKA Disaster Number AK–00039] James Rivera, Audit Findings Remediation, Ongoing Presidential Declaration of a Major Associate Administrator for Disaster OIG Audits including the Information Disaster for Public Assistance Only for Assistance. Technology Audit, FMFIA Assurance/ the State of ALASKA [FR Doc. 2018–20407 Filed 9–19–18; 8:45 am] A–123 Internal Control Program, Credit BILLING CODE 8025–01–P Modeling, Performance Management, AGENCY: U.S. Small Business Acquisition Division Update, Improper Administration. Payments and current initiatives. ACTION: Notice. SMALL BUSINESS ADMINISTRATION Timothy Gribben, SUMMARY: This is a Notice of the Audit and Financial Management Chief Financial Officer and Associate Presidential declaration of a major Advisory Committee (AFMAC) Administrator, Office of Performance disaster for Public Assistance Only for Management and Chief Financial Officer. AGENCY: the State of ALASKA (FEMA—4391— U.S. Small Business [FR Doc. 2018–20493 Filed 9–19–18; 8:45 am] Administration. DR), dated 09/05/2018. BILLING CODE 8025–01–P Incident: Flooding. ACTION: Notice of open Federal Advisory Incident Period: 05/11/2018 through committee meeting. SMALL BUSINESS ADMINISTRATION 05/13/2018. SUMMARY: The SBA is issuing this notice DATES: Issued on 09/05/2018. to announce the location, date, time and [Disaster Declaration #15688 and #15689; Physical Loan Application Deadline agenda for the next meeting of the Audit MINNESOTA Disaster Number MN–00063] Date: 11/05/2018. and Financial Management Advisory Presidential Declaration of a Major Economic Injury (EIDL) Loan Committee (AFMAC). The meeting will Application Deadline Date: 06/05/2019. Disaster for Public Assistance Only for be open to the public. the State of Minnesota ADDRESSES: Submit completed loan DATES: The meeting will be held on applications to: U.S. Small Business Wednesday, October 31, 2018, starting AGENCY: U.S. Small Business Administration, Processing and at 2:00 p.m. until approximately 4:00 Administration. Disbursement Center, 14925 Kingsport p.m. Eastern time. ACTION: Notice. Road, Fort Worth, TX 76155. ADDRESSES: The meeting will be held at SUMMARY: This is a Notice of the FOR FURTHER INFORMATION CONTACT: A. the U.S. Small Business Administration, Escobar, Office of Disaster Assistance, 409 3rd Street SW, Office of Presidential declaration of a major U.S. Small Business Administration, Performance Management and Chief disaster for Public Assistance Only for 409 3rd Street SW, Suite 6050, Financial Officer Conference Room, 6th the State of Minnesota (FEMA–4390– Washington, DC 20416, (202) 205–6734. Floor, Washington, DC 20416. DR), dated 09/05/2018. Incident: Severe Storms, Tornadoes, FOR FURTHER INFORMATION CONTACT: The SUPPLEMENTARY INFORMATION: Notice is Straight-line Winds, and Flooding. hereby given that as a result of the meeting is open to the public; however Incident Period: 06/15/2018 through President’s major disaster declaration on advance notice of attendance is 07/11/2018. 09/05/2018, Private Non-Profit requested. Anyone wishing to attend and/or make a presentation to the DATES: Issued on 09/05/2018. organizations that provide essential Physical Loan Application Deadline services of a governmental nature may AFMAC must contact Tim Gribben by fax or email, in order to be placed on the Date: 11/05/2018. file disaster loan applications at the Economic Injury (EIDL) Loan agenda. Tim Gribben, Chief Financial address listed above or other locally Application Deadline Date: 06/05/2019. announced locations. Officer, 409 3rd Street SW, 6th Floor, ADDRESSES: Submit completed loan The following areas have been Washington, DC 20416, phone (202) 205–6449; fax: (202) 481–0546; email: applications to: U.S. Small Business determined to be adversely affected by Administration, Processing and the disaster: [email protected]. Additionally, if you need Disbursement Center, 14925 Kingsport Primary Counties: Matanuska-Susitna accommodations because of a disability Road, Fort Worth, TX 76155. Borough. or require additional information, please FOR FURTHER INFORMATION CONTACT: A. The Interest Rates are: contact Donna Wood at (202) 619–1608; Escobar, Office of Disaster Assistance, email [email protected]; SBA Office U.S. Small Business Administration, Percent of Performance Management & Chief 409 3rd Street SW, Suite 6050, Financial Officer, 409 3rd Street SW, Washington, DC 20416, (202) 205–6734. For Physical Damage: Washington, DC 20416. For more Non-Profit Organizations with SUPPLEMENTARY INFORMATION: Notice is Credit Available Elsewhere ... 2.500 information, please visit www.sba.gov/ hereby given that as a result of the Non-Profit Organizations with- about-sba/sba-performance. President’s major disaster declaration on out Credit Available Else- SUPPLEMENTARY INFORMATION: Pursuant 09/05/2018, Private Non-Profit where ...... 2.500 to section 10(a)(2) of the Federal organizations that provide essential

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services of a governmental nature may Financial Officer Conference Room, 6th 16) to test and evaluate the delegation file disaster loan applications at the Floor, Washington, DC 20416. of program-level responsibilities of the address listed above or other locally FOR FURTHER INFORMATION CONTACT: The Federal-aid highway program (FAHP) to announced locations. meeting is open to the public; however States, including the appropriate steps The following areas have been advance notice of attendance is States should take to request to exercise determined to be adversely affected by requested. Anyone wishing to attend delegated authority. The FHWA the disaster: and/or make a presentation to the anticipates there is interest in State Primary Counties: Aitkin, Beltrami, Blue AFMAC must contact Tim Gribben by assumption of program-level actions for Earth, Brown, Carlton, Cass, fax or email, in order to be placed on the approval of design standards, noise Clearwater, Cottonwood, Faribault, agenda. Tim Gribben, Chief Financial policies, preventative maintenance Itasca, Jackson, Koochiching, Lake, Officer, 409 3rd Street SW, 6th Floor, programs, and real property acquisitions Lyon, Martin, Murray, Nicollet, Washington, DC 20416, phone (202) and disposals. The term ‘‘program-level Nobles, Pine, Pipestone, Polk, 205–6449; fax: (202) 481–0546; email: actions’’ in this context means decisions Redwood, Renville, Rock, St. Louis, [email protected]. that apply generally to projects in a Sibley, and Watonwan Counties, Additionally, if you need State and broadly affect the and the Leech Lake Band of Ojibwe, accommodations because of a disability implementation of the Federal-aid Red Lake Nation, and White Earth or require additional information, please highway program in the State, but Nation contact Donna Wood at (202) 619–1608, excludes Federal decisions relating to The Interest Rates are: email: [email protected]; SBA eligibility, obligation, reimbursement, Office of Performance Management & authorization, and compliance. Percent Chief Financial Officer, 409 3rd Street DATES: This new SEP–16 project is being SW, Washington, DC 20416. For more initiated on September 20, 2018. For Physical Damage: information, please visit www.sba.gov/ FOR FURTHER INFORMATION CONTACT: For Non-Profit Organizations with about-sba/sba-performance. Credit Available Elsewhere ... 2.500 technical information: Cindi Ptak, Office SUPPLEMENTARY INFORMATION: Pursuant of Innovative Program Delivery (HIN), Non-Profit Organizations with- to section 10(a)(2) of the Federal out Credit Available Else- (202) 366–8408; for legal information: where ...... 2.500 Advisory Committee Act (5 U.S.C., Janet Myers, Office of the Chief Counsel For Economic Injury: Appendix 2), SBA announces the (HCC), (202) 366–2019, 1200 New Jersey Non-Profit Organizations with- meeting of the AFMAC. The AFMAC is Avenue SE, Washington, DC 20590. out Credit Available Else- tasked with providing recommendation Office hours are from 8:00 a.m. to 4:30 where ...... 2.500 and advice regarding the Agency’s p.m., ET, Monday through Friday, financial management, including the except Federal holidays. The number assigned to this disaster financial reporting process, systems of SUPPLEMENTARY INFORMATION: for physical damage is 156886 and for internal controls, audit process and economic injury is 156890. process for monitoring compliance with Electronic Access relevant law and regulations. (Catalog of Federal Domestic Assistance An electronic copy of this notice may Number 59008) The purpose of the meeting is to discuss the SBA’s Financial Reporting, be downloaded from the Federal James Rivera, Audit Findings Remediation, Ongoing Register’s home page at: http:// Associate Administrator for Disaster OIG Audits including the Information www.archives.gov; the Government Assistance. Technology Audit, FMFIA Assurance/ Publishing Office’s database at: https:// [FR Doc. 2018–20406 Filed 9–19–18; 8:45 am] A–123 Internal Control Program, Credit www.gpo.gov/fdsys/; or the specific docket page at: www.regulations.gov. BILLING CODE 8025–01–P Modeling, Performance Management, Acquisition Division Update, Improper Background Payments and current initiatives. SMALL BUSINESS ADMINISTRATION The Fixing America’s Surface Timothy Gribben, Transportation (FAST) Act (Pub. L. 114– Audit and Financial Management Chief Financial Officer and Associate 94) builds on the authorities and Advisory Committee (AFMAC) Administrator, Office of Performance requirements in earlier legislation to Management and Chief Financial Officer. promote the transition from FHWA AGENCY: U.S. Small Business [FR Doc. 2018–20491 Filed 9–19–18; 8:45 am] project-level ‘‘full-oversight’’ of the Administration. BILLING CODE P FAHP to a risk-based approach to ACTION: Notice of open Federal Advisory FHWA oversight activities. The FHWA’s committee meeting use of a risk-based approach to DEPARTMENT OF TRANSPORTATION stewardship and oversight is intended SUMMARY: The SBA is issuing this notice to optimize the successful delivery of to announce the location, date, time and Federal Highway Administration projects and to ensure compliance with agenda for the next meeting of the Audit Federal requirements by focusing and Financial Management Advisory New Special Experimental Project FHWA resources most efficiently and Committee (AFMAC). The meeting will (SEP–16) To Evaluate Proposals for effectively. be open to the public. Delegation of Certain Program-Wide Unless authorized by law, FHWA may DATES: The meeting will be held on FHWA Responsibilities to States not delegate or assign its decision- Friday, October 5, 2018, starting at 1:00 AGENCY: Federal Highway making responsibilities to a State p.m. until approximately 3:00 p.m. Administration (FHWA), U.S department of transportation (State Eastern Time. Department of Transportation (DOT). DOT). Section 106(c) of Title 23, United ADDRESSES: The meeting will be held at ACTION: Notice. States Code (U.S.C.), authorizes States to the U.S. Small Business Administration, assume project responsibilities for 409 3rd Street SW, Office of SUMMARY: The FHWA is establishing a design, plans, specifications, estimates, Performance Management and Chief new Special Experimental Project (SEP– contract awards, and inspections for

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projects that receive funding under Title program. The FHWA is establishing this demonstrate experience with project- 23, U.S.C., and are on the National SEP–16 to consider program-level level delegation in the affected program Highway System (NHS), including authorities (as opposed to project-level area(s), if applicable, as well as the level projects on the Interstate System. The actions) States may want to assume. The of collaboration conducted so far with States may assume these responsibilities term ‘‘program-level authority’’ in this relevant FHWA Division or Program unless FHWA, acting under a delegation context means decisions that apply Offices about the proposal. of authority from the Secretary, generally to projects in a State and Application Process determines that the assumption is not broadly affect the Federal-aid system in appropriate (23 U.S.C. 106(c)(1)). For the State, but excludes Federal The application process is three-tiered non-NHS projects, States must assume decisions relating to eligibility, with each step developing more such responsibilities (23 U.S.C. obligation, reimbursement, specifics of the proposed program-level 106(c)(2)). authorization, and compliance. assumption(s) for FHWA consideration Section 1316(a) of the FAST Act This SEP–16 is intended to allow and feedback. The FHWA will evaluate directs the Secretary of Transportation States to propose the assumption of each step to determine whether a to use the authority under 23 U.S.C. Title 23 program-level responsibilities proposal falls within the scope of 106(c) to the maximum extent provided they can demonstrate they section 502(b) and is appropriate for this practicable to allow a State to assume have, or can reasonably put in place, the experimental process before inviting the responsibilities described in 23 necessary laws, regulations, controls, and working with an Applicant to U.S.C. 106(c) on both a project-specific and resources to take on the Federal proceed to the next step for more and a programmatic basis. Section 1316 role. Because States already have detailed proposal development. of the FAST Act seeks to expand the use experience with project-level The first step in the application of the 23 U.S.C. 106(c) authority for assumptions under 23 U.S.C. 106(c), process is the Letter of Interest State assumption of responsibilities. FHWA anticipates initially receiving described above. The FHWA will State assumption of certain proposals for program-level authority acknowledge receipt of the Letter of responsibilities is part of the transition affecting these types of areas. Interest and provide an anticipated to risk-based oversight of the FAHP. To This SEP–16 will allow FHWA to timeframe for initially evaluating the implement section 1316 of the FAST understand the implications of proposal and providing a formal Act, FHWA published a Federal delegation of program-wide decisions in response. After review of the proposal, Register notice soliciting feedback from various program areas. The lessons FHWA will provide a formal response States and other stakeholders on learned from SEP–16 will aid FHWA in that will either request the Applicant to additional project-level authorities to developing comprehensive policies and proceed with submitting a Concept assume under Title 23.1 The responses inform stakeholders if the delegation of Paper, or provide FHWA’s explanation received indicated an interest in State specific program-level authorities, or for not advancing the proposal. assumption of program-level actions for other discretionary authorities If a Concept Paper is requested, the approval of design standards, noise established in Title 23, is appropriate. Applicant should submit to the policies, preventative maintenance To facilitate public access to SEP–16 appropriate FHWA Division Office a programs, and utility procedures, as information, all SEP–16 proposals, narrative further detailing the well as some areas of real estate workplans, and reports will be posted Applicant’s proposal. This Concept acquisition. Some responses requested on a public facing website. Paper should not exceed 5 pages and be formatted single-spaced, using a authority in areas that FHWA has Solicitation of Letters of Interest determined already are within the 23 standard 12-point font with 1-inch U.S.C. 106(c) assumption authority. This notice announces SEP–16 and margins. Charts, tables, and other items The FHWA is initiating a new SEP– requests Letters of Interest. Entities may also be submitted as attachments to 16 pursuant to authority granted to the eligible to submit letters (‘‘Applicants’’) supplement the narrative and do not Secretary in 23 U.S.C. 502(b) to evaluate are State DOTs as defined in 23 U.S.C. count toward the five-page limit. The potential effects of State assumption of 101. Letters of Interest, which should be Concept Paper should demonstrate that program-level FAHP responsibilities submitted to the appropriate FHWA the State has the necessary laws, that are not currently assumable. The Division Office, initiate the application regulations, controls, and resources in experimental authority may be used to process described below. The Letter of place to assume the Federal role for the test deviations from Title 23 statutory, Interest should include a high-level program-level responsibilities regulatory, or policy provisions, description of the Applicant’s proposal, requested. If applicable, the Applicant provided that the experimental features reasons for wanting to assume the may use experience with assumption of are consistent with the overall purpose program-level authority, and the project-level authorities to demonstrate and intent of the underlying statute, anticipated resulting improvements to readiness to assume program-level regulation, or policy being tested. program delivery. Ideally, the Applicant responsibilities. If any necessary piece Actions explicitly prohibited by statute will quantify the resulting is missing, the Applicant should outline cannot be the subject of a SEP–16 improvements in terms of project time a plan and timeline anticipated to put experiment. The experiment must be and/or cost savings. The Applicant pieces in place. In addition, the Concept consistent with other Federal laws that should include enough detail to allow Paper should detail supporting analysis apply to Title 23 funded activities. For FHWA to determine how the proposal for the anticipated program delivery example, the recording statute, 31 deviates from current law (including improvements and consider a risk U.S.C. 1501, and the Antideficiency Act regulations) and practice, and how the assessment of the expected impact the (31 U.S.C. 1341(a)(1)(A)), vest the actions covered by the proposal are assumption of authority may have on responsibility to record obligations of addressed in current policy. The Letter the State’s program—specifically on the Federal Government with the of Interest should reference the Title 23 resources, processes, and stakeholders— Federal agency responsible for program and the specific legal and include measures the State would administering the Federal assistance authority(ies) being requested for use to ensure the responsibilities are delegation. Further, the Applicant carried out in accordance with Federal 1 81 FR 59715 (August 30, 2016). should provide specific examples that requirements. The Concept Paper

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should also summarize any preparation DEPARTMENT OF TRANSPORTATION Washington, DC 20590. Telephone 202– the Applicant may need to make if the 366–9309, Email [email protected]. experiment is approved and the time Maritime Administration SUPPLEMENTARY INFORMATION: As necessary for that preparation (e.g., [Docket No. MARAD–2018–0148] described by the applicant the intended provide training for staff; make needed service of the vessel REBEL SOUL is: changes to procedures, organization Requested Administrative Waiver of —Intended Commercial use of Vessel: charts, etc.). The FHWA will evaluate the Coastwise Trade Laws: Vessel ‘‘Charter sport fishing and cruising’’ the Concept Paper, and either request REBEL SOUL; Invitation for Public —Geographic Region Including Base of the Applicant to proceed to the Detailed Comments Operations: ‘‘Florida’’ (Base of Proposal stage, or provide an AGENCY: Maritime Administration, DOT. Operations: Fort Lauderdale, FL) explanation for not advancing the ′ ACTION: Notice. —Vessel Length and Type: 65 motor request. vessel Since the requirements for the SUMMARY: The Secretary of The complete application is available Detailed Proposal will vary depending Transportation, as represented by the for review identified in the DOT docket on the complexity of the proposed Maritime Administration (MARAD), is as MARAD–2018–0148 at http:// program assumption and the results of authorized to grant waivers of the U.S.- www.regulations.gov. Interested parties FHWA’s evaluation of the Concept build requirements of the coastwise may comment on the effect this action Paper, the appropriate FHWA Division trade laws to allow the carriage of no may have on U.S. vessel builders or will coordinate with the Applicant in more than twelve passengers for hire on businesses in the U.S. that use U.S.-flag preparing the Detailed Proposal. At a vessels, which are three years old or vessels. If MARAD determines, in more. A request for such a waiver has minimum, the Applicant’s Detailed accordance with 46 U.S.C. 12121 and been received by MARAD. The vessel, Proposal should: (1) Propose a duration MARAD’s regulations at 46 CFR part and a brief description of the proposed 388, that the issuance of the waiver will for conducting the experiment, service, is listed below. including a timeline for any transition have an unduly adverse effect on a U.S.- DATES: Submit comments on or before activities; (2) identify key personnel and vessel builder or a business that uses October 22, 2018. contacts with proposed roles and U.S.-flag vessels in that business, a responsibilities; and (3) recommend an ADDRESSES: You may submit comments waiver will not be granted. Comments Evaluation Plan with reporting identified by DOT Docket Number should refer to the vessel name, state the commenter’s interest in the waiver mechanisms, performance measures, MARAD–2018–0148 by any one of the following methods: application, and address the waiver goals, and other evaluation criteria, and • Federal eRulemaking Portal: Go to criteria given in section 388.4 of frequency of reviews. To provide http://www.regulations.gov. Search MARAD’s regulations at 46 CFR part consistency among the SEP–16 MARAD–2018–0148 and follow the 388. experiments, FHWA will provide the instructions for submitting comments. Public Participation Applicant certain performance measures • Mail or Hand Delivery: Docket and evaluation criteria common to all Management Facility is in the West How do I submit comments? SEP–16 Evaluation Plans. Building, Ground Floor of the U.S. Please submit your comments, Should FHWA decide to proceed with Department of Transportation. The including the attachments, following the the experiment, FHWA and the Docket Management Facility location instructions provided under the above address is: U.S. Department of Applicant will enter into a heading entitled ADDRESSES. Be advised memorandum of understanding and Transportation, MARAD–2018–0148, • that it may take a few hours or even develop a workplan for the experiment. 1200 New Jersey Avenue SE, West days for your comment to be reflected Building, Room W12–140, Washington, Conclusion on the docket. In addition, your DC 20590, between 9 a.m. and 5 p.m., comments must be written in English. Monday through Friday, except on We encourage you to provide concise The FHWA is committed to Federal holidays. continuing its transition to a risk-based comments and you may attach approach to stewardship and oversight Note: If you mail or hand-deliver your additional documents as necessary. comments, we recommend that you include of the FAHP. To this end, SEP–16 is There is no limit on the length of the your name and a mailing address, an email attachments. designed to provide FHWA with a better address, or a telephone number in the body understanding of the implications of of your document so that we can contact you Where do I go to read public comments, allowing States to assume program-level if we have questions regarding your and find supporting information? authorities in various program areas. submission. Go to the docket online at http:// This notice announces the SEP–16 and Instructions: All submissions received www.regulations.gov., keyword search identifies the process for States to apply must include the agency name and MARAD–2018–0148 or visit the Docket to assume program-level responsibilities specific docket number. All comments Management Facility (see ADDRESSES for for the FAHP in their States. received will be posted without change hours of operation). We recommend that (Authority: 23 U.S.C. 315 and 502). to the docket at www.regulations.gov, you periodically check the Docket for including any personal information Issued in Washington, DC, on September new submissions and supporting provided. For detailed instructions on material. 11, 2018. submitting comments, see the section Brandye L. Hendrickson, entitled Public Participation. Will my comments be made available to Deputy Administrator, Federal Highway FOR FURTHER INFORMATION CONTACT: the public? Administration. Bianca Carr, U.S. Department of Yes. Be aware that your entire [FR Doc. 2018–20347 Filed 9–19–18; 8:45 am] Transportation, Maritime comment, including your personal BILLING CODE 4910–22–P Administration, 1200 New Jersey identifying information, will be made Avenue SE, Room W23–453, publicly available.

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May I submit comments confidentially? more than twelve passengers for hire on may have on U.S. vessel builders or If you wish to submit comments vessels, which are three years old or businesses in the U.S. that use U.S.-flag under a claim of confidentiality, you more. A request for such a waiver has vessels. If MARAD determines, in should submit three copies of your been received by MARAD. The vessel, accordance with 46 U.S.C. 12121 and complete submission, including the and a brief description of the proposed MARAD’s regulations at 46 CFR part information you claim to be confidential service, is listed below. 388, that the issuance of the waiver will business information, to the Department DATES: Submit comments on or before have an unduly adverse effect on a U.S.- of Transportation, Maritime October 22, 2018. vessel builder or a business that uses Administration, Office of Legislation ADDRESSES: You may submit comments U.S.-flag vessels in that business, a and Regulations, MAR–225, W24–220, identified by DOT Docket Number waiver will not be granted. Comments 1200 New Jersey Avenue SE, MARAD–2018–0147 by any one of the should refer to the vessel name, state the Washington, DC 20590. Include a cover following methods: commenter’s interest in the waiver letter setting forth with specificity the • Federal eRulemaking Portal: Go to application, and address the waiver basis for any such claim and, if possible, http://www.regulations.gov. Search criteria given in section 388.4 of a summary of your submission that can MARAD–2018–0147 and follow the MARAD’s regulations at 46 CFR part be made available to the public. instructions for submitting comments. 388. • Mail or Hand Delivery: Docket Privacy Act Public Participation Management Facility is in the West In accordance with 5 U.S.C. 553(c), Building, Ground Floor of the U.S. How do I submit comments? DOT solicits comments from the public Department of Transportation. The to better inform its rulemaking process. Please submit your comments, Docket Management Facility location including the attachments, following the DOT posts these comments, without address is: U.S. Department of edit, to www.regulations.gov, as instructions provided under the above Transportation, MARAD–2018–0147, heading entitled ADDRESSES. Be advised described in the system of records 1200 New Jersey Avenue SE, West notice, DOT/ALL–14 FDMS, accessible that it may take a few hours or even Building, Room W12–140, Washington, days for your comment to be reflected through www.dot.gov/privacy. To DC 20590, between 9 a.m. and 5 p.m., facilitate comment tracking and on the docket. In addition, your Monday through Friday, except on comments must be written in English. response, we encourage commenters to Federal holidays. provide their name, or the name of their We encourage you to provide concise Note: If you mail or hand-deliver your organization; however, submission of comments and you may attach comments, we recommend that you include additional documents as necessary. names is completely optional. Whether your name and a mailing address, an email or not commenters identify themselves, There is no limit on the length of the address, or a telephone number in the body attachments. all timely comments will be fully of your document so that we can contact you considered. If you wish to provide if we have questions regarding your Where do I go to read public comments, comments containing proprietary or submission. and find supporting information? confidential information, please contact Instructions: All submissions received Go to the docket online at http:// the agency for alternate submission must include the agency name and www.regulations.gov., keyword search instructions. specific docket number. All comments MARAD–2018–0147 or visit the Docket (Authority: 49 CFR 1.93(a), 46 U.S.C. 55103, received will be posted without change Management Facility (see ADDRESSES for 46 U.S.C. 12121) to the docket at www.regulations.gov, hours of operation). We recommend that *** including any personal information you periodically check the Docket for provided. For detailed instructions on Dated: September 17, 2018. new submissions and supporting submitting comments, see the section By Order of the Maritime Administrator. material. entitled Public Participation. T. Mitchell Hudson, Jr., FOR FURTHER INFORMATION CONTACT: Will my comments be made available to Secretary, Maritime Administration. Bianca Carr, U.S. Department of the public? [FR Doc. 2018–20463 Filed 9–19–18; 8:45 am] Transportation, Maritime BILLING CODE 4910–81–P Yes. Be aware that your entire Administration, 1200 New Jersey comment, including your personal Avenue SE, Room W23–453, identifying information, will be made Washington, DC 20590. Telephone 202– DEPARTMENT OF TRANSPORTATION publicly available. 366–9309, Email [email protected]. Maritime Administration SUPPLEMENTARY INFORMATION: As May I submit comments confidentially? described by the applicant the intended [Docket No. MARAD–2018–0147] If you wish to submit comments service of the vessel ONE IRON is: under a claim of confidentiality, you Requested Administrative Waiver of —Intended Commercial Use of Vessel: should submit three copies of your the Coastwise Trade Laws: Vessel ‘‘pleasure charters, day charters complete submission, including the ONE IRON; Invitation for Public around the Miami Area’’ information you claim to be confidential Comments —Geographic Region Including Base of business information, to the Department Operations: ‘‘Florida’’ (Base of of Transportation, Maritime AGENCY: Maritime Administration, DOT. Operations: Miami, FL) ACTION: Notice. ′ Administration, Office of Legislation —Vessel Length and Type: 49 motor and Regulations, MAR–225, W24–220, SUMMARY: The Secretary of vessel 1200 New Jersey Avenue SE, Transportation, as represented by the The complete application is available Washington, DC 20590. Include a cover Maritime Administration (MARAD), is for review identified in the DOT docket letter setting forth with specificity the authorized to grant waivers of the U.S.- as MARAD–2018–0147 at http:// basis for any such claim and, if possible, build requirements of the coastwise www.regulations.gov. Interested parties a summary of your submission that can trade laws to allow the carriage of no may comment on the effect this action be made available to the public.

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Privacy Act • Mail or Hand Delivery: Docket commenter’s interest in the waiver In accordance with 5 U.S.C. 553(c), Management Facility is in the West application, and address the waiver DOT solicits comments from the public Building, Ground Floor of the U.S. criteria given in section 388.4 of to better inform its rulemaking process. Department of Transportation. The MARAD’s regulations at 46 CFR part DOT posts these comments, without Docket Management Facility location 388. edit, to www.regulations.gov, as address is: U.S. Department of Public Participation described in the system of records Transportation, MARAD–2018–0149, How do I submit comments? notice, DOT/ALL–14 FDMS, accessible 1200 New Jersey Avenue SE, West through www.dot.gov/privacy. To Building, Room W12–140, Washington, Please submit your comments, facilitate comment tracking and DC 20590, between 9 a.m. and 5 p.m., including the attachments, following the response, we encourage commenters to Monday through Friday, except on instructions provided under the above provide their name, or the name of their Federal holidays. heading entitled ADDRESSES. Be advised organization; however, submission of Note: If you mail or hand-deliver your that it may take a few hours or even names is completely optional. Whether comments, we recommend that you include days for your comment to be reflected or not commenters identify themselves, your name and a mailing address, an email on the docket. In addition, your all timely comments will be fully address, or a telephone number in the body comments must be written in English. of your document so that we can contact you We encourage you to provide concise considered. If you wish to provide if we have questions regarding your comments containing proprietary or submission. comments and you may attach confidential information, please contact additional documents as necessary. Instructions: All submissions received the agency for alternate submission There is no limit on the length of the must include the agency name and instructions. attachments. specific docket number. All comments (Authority: 49 CFR 1.93(a), 46 U.S.C. 55103, received will be posted without change Where do I go to read public comments, 46 U.S.C. 12121) to the docket at www.regulations.gov, and find supporting information? *** including any personal information Go to the docket online at http:// Dated: September 17, 2018. provided. For detailed instructions on www.regulations.gov., keyword search By Order of the Maritime Administrator. submitting comments, see the section MARAD–2018–0149 or visit the Docket T. Mitchell Hudson, Jr., entitled Public Participation. Management Facility (see ADDRESSES for hours of operation). We recommend that Secretary, Maritime Administration. FOR FURTHER INFORMATION CONTACT: Bianca Carr, U.S. Department of you periodically check the Docket for [FR Doc. 2018–20462 Filed 9–19–18; 8:45 am] Transportation, Maritime new submissions and supporting BILLING CODE 4910–81–P Administration, 1200 New Jersey material. Avenue SE, Room W23–453, Will my comments be made available to DEPARTMENT OF TRANSPORTATION Washington, DC 20590. Telephone 202– the public? 366–9309, Email [email protected]. Yes. Be aware that your entire Maritime Administration SUPPLEMENTARY INFORMATION: As comment, including your personal described by the applicant the intended [Docket No. MARAD–2018–0149] identifying information, will be made service of the vessel RICHARD H. publicly available. Requested Administrative Waiver of DANA is: the Coastwise Trade Laws: Vessel —Intended Commercial Use of Vessel: May I submit comments confidentially? RICHARD H. DANA; Invitation for ‘‘Coastwise transportation of If you wish to submit comments Public Comments passengers between points in the under a claim of confidentiality, you United States, its territorial sea, or the should submit three copies of your AGENCY: Maritime Administration, DOT. EEZ. This includes carriage of complete submission, including the ACTION: Notice. passengers, including charter parties, information you claim to be confidential entirely within our territorial waters.’’ business information, to the Department SUMMARY: The Secretary of —Geographic Region Including Base of of Transportation, Maritime Transportation, as represented by the Operations: ‘‘California’’ (Base of Administration, Office of Legislation Maritime Administration (MARAD), is Operations: San Diego, CA) and Regulations, MAR–225, W24–220, authorized to grant waivers of the U.S.- ′ —Vessel Length and Type: 35 full 1200 New Jersey Avenue SE, build requirements of the coastwise keeled cutter rigged twin masted Washington, DC 20590. Include a cover trade laws to allow the carriage of no ketch sailboat letter setting forth with specificity the more than twelve passengers for hire on The complete application is available basis for any such claim and, if possible, vessels, which are three years old or for review identified in the DOT docket a summary of your submission that can more. A request for such a waiver has as MARAD–2018–0149 at http:// be made available to the public. been received by MARAD. The vessel, www.regulations.gov. Interested parties and a brief description of the proposed may comment on the effect this action Privacy Act service, is listed below. may have on U.S. vessel builders or In accordance with 5 U.S.C. 553(c), DATES: Submit comments on or before businesses in the U.S. that use U.S.-flag DOT solicits comments from the public October 22, 2018. vessels. If MARAD determines, in to better inform its rulemaking process. ADDRESSES: You may submit comments accordance with 46 U.S.C. 12121 and DOT posts these comments, without identified by DOT Docket Number MARAD’s regulations at 46 CFR part edit, to www.regulations.gov, as MARAD–2018–0149 by any one of the 388, that the issuance of the waiver will described in the system of records following methods: have an unduly adverse effect on a U.S.- notice, DOT/ALL–14 FDMS, accessible • Federal eRulemaking Portal: Go to vessel builder or a business that uses through www.dot.gov/privacy. To http://www.regulations.gov. Search U.S.-flag vessels in that business, a facilitate comment tracking and MARAD–2018–0149 and follow the waiver will not be granted. Comments response, we encourage commenters to instructions for submitting comments. should refer to the vessel name, state the provide their name, or the name of their

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organization; however, submission of Note: If you mail or hand-deliver your We encourage you to provide concise names is completely optional. Whether comments, we recommend that you include comments and you may attach or not commenters identify themselves, your name and a mailing address, an email additional documents as necessary. address, or a telephone number in the body all timely comments will be fully of your document so that we can contact you There is no limit on the length of the considered. If you wish to provide if we have questions regarding your attachments. comments containing proprietary or submission. Where do I go to read public comments, confidential information, please contact Instructions: All submissions received and find supporting information? the agency for alternate submission must include the agency name and instructions. specific docket number. All comments Go to the docket online at http:// (Authority: 49 CFR 1.93(a), 46 U.S.C. 55103, received will be posted without change www.regulations.gov., keyword search 46 U.S.C. 12121) to the docket at www.regulations.gov, MARAD–2018–0146 or visit the Docket *** including any personal information Management Facility (see ADDRESSES for hours of operation). We recommend that Dated: September 17, 2018. provided. For detailed instructions on you periodically check the Docket for By Order of the Maritime Administrator. submitting comments, see the section entitled Public Participation. new submissions and supporting T. Mitchell Hudson, Jr., FOR FURTHER INFORMATION CONTACT: material. Secretary, Maritime Administration. Bianca Carr, U.S. Department of [FR Doc. 2018–20464 Filed 9–19–18; 8:45 am] Will my comments be made available to Transportation, Maritime the public? BILLING CODE 4910–81–P Administration, 1200 New Jersey Avenue SE, Room W23–453, Yes. Be aware that your entire Washington, DC 20590. Telephone 202– comment, including your personal DEPARTMENT OF TRANSPORTATION 366–9309, Email [email protected]. identifying information, will be made Maritime Administration SUPPLEMENTARY INFORMATION: As publicly available. described by the applicant the intended May I submit comments confidentially? [Docket No. MARAD–2018–0146] service of the vessel GIOVANNINO is: —Intended Commercial Use of Vessel: Requested Administrative Waiver of If you wish to submit comments ‘‘Term charters, week long all- the Coastwise Trade Laws: Vessel under a claim of confidentiality, you inclusive yacht charters’’ should submit three copies of your GIOVANNINO; Invitation for Public —Geographic Region Including Base of Comments complete submission, including the Operations: ‘‘Florida, Georgia, North information you claim to be confidential AGENCY: Maritime Administration, DOT. Carolina, South Carolina, Virginia, business information, to the Department ACTION: Notice. Delaware’’ (Base of Operations: of Transportation, Maritime Nassau, Bahamas) Administration, Office of Legislation ′ SUMMARY: The Secretary of —Vessel Length and Type: 52 power and Regulations, MAR–225, W24–220, Transportation, as represented by the catamaran 1200 New Jersey Avenue SE, Maritime Administration (MARAD), is The complete application is available Washington, DC 20590. Include a cover authorized to grant waivers of the U.S.- for review identified in the DOT docket letter setting forth with specificity the build requirements of the coastwise as MARAD–2018–0146 at http:// basis for any such claim and, if possible, trade laws to allow the carriage of no www.regulations.gov. Interested parties a summary of your submission that can more than twelve passengers for hire on may comment on the effect this action be made available to the public. vessels, which are three years old or may have on U.S. vessel builders or Privacy Act more. A request for such a waiver has businesses in the U.S. that use U.S.-flag been received by MARAD. The vessel, vessels. If MARAD determines, in In accordance with 5 U.S.C. 553(c), and a brief description of the proposed accordance with 46 U.S.C. 12121 and DOT solicits comments from the public service, is listed below. MARAD’s regulations at 46 CFR part to better inform its rulemaking process. DATES: Submit comments on or before 388, that the issuance of the waiver will DOT posts these comments, without October 22, 2018. have an unduly adverse effect on a U.S.- edit, to www.regulations.gov, as ADDRESSES: You may submit comments vessel builder or a business that uses described in the system of records identified by DOT Docket Number U.S.-flag vessels in that business, a notice, DOT/ALL–14 FDMS, accessible MARAD 2018–0146 by any one of the waiver will not be granted. Comments through www.dot.gov/privacy. To following methods: should refer to the vessel name, state the facilitate comment tracking and • Federal eRulemaking Portal: Go to commenter’s interest in the waiver response, we encourage commenters to http://www.regulations.gov. Search application, and address the waiver provide their name, or the name of their MARAD–2018–0146 and follow the criteria given in section 388.4 of organization; however, submission of instructions for submitting comments. MARAD’s regulations at 46 CFR part names is completely optional. Whether • Mail or Hand Delivery: Docket 388. or not commenters identify themselves, Management Facility is in the West Public Participation all timely comments will be fully Building, Ground Floor of the U.S. considered. If you wish to provide Department of Transportation. The How do I submit comments? comments containing proprietary or Docket Management Facility location Please submit your comments, confidential information, please contact address is: U.S. Department of including the attachments, following the the agency for alternate submission Transportation, MARAD–2018–0146, instructions provided under the above instructions. 1200 New Jersey Avenue SE, West heading entitled ADDRESSES. Be advised (Authority: 49 CFR 1.93(a), 46 U.S.C. 55103, Building, Room W12–140, Washington, that it may take a few hours or even 46 U.S.C. 12121) DC 20590, between 9 a.m. and 5 p.m., days for your comment to be reflected Monday through Friday, except on on the docket. In addition, your *** Federal holidays. comments must be written in English. Dated: September 17, 2018.

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By Order of the Maritime Administrator. submitting comments, see the section you periodically check the Docket for T. Mitchell Hudson, Jr., entitled Public Participation. new submissions and supporting Secretary, Maritime Administration. FOR FURTHER INFORMATION CONTACT: material. [FR Doc. 2018–20459 Filed 9–19–18; 8:45 am] Bianca Carr, U.S. Department of Will my comments be made available to Transportation, Maritime BILLING CODE 4910–81–P the public? Administration, 1200 New Jersey Avenue SE, Room W23–453, Yes. Be aware that your entire DEPARTMENT OF TRANSPORTATION Washington, DC 20590. Telephone 202– comment, including your personal 366–9309, Email [email protected]. Maritime Administration identifying information, will be made SUPPLEMENTARY INFORMATION: As publicly available. [Docket No. MARAD–2018–0145] described by the applicant the intended service of the vessel FIRST WAVE is: May I submit comments confidentially? Requested Administrative Waiver of —Intended Commercial Use of Vessel: the Coastwise Trade Laws: Vessel If you wish to submit comments ‘‘sunset cruises, half day or full day under a claim of confidentiality, you FIRST WAVE; Invitation for Public sailing trips, catamaran charters. On Comments should submit three copies of your rare occasions, we might do a short complete submission, including the two or three-day cruise.’’ AGENCY: Maritime Administration, DOT. information you claim to be confidential —Geographic Region Including Base of ACTION: Notice. business information, to the Department Operations: ‘‘Florida’’ (Base of of Transportation, Maritime SUMMARY: Operations: South Florida) The Secretary of Administration, Office of Legislation Transportation, as represented by the —Vessel Length and Type: 39′ and Regulations, MAR–225, W24–220, Maritime Administration (MARAD), is Catamaran 1200 New Jersey Avenue SE, authorized to grant waivers of the U.S.- The complete application is available Washington, DC 20590. Include a cover build requirements of the coastwise for review identified in the DOT docket letter setting forth with specificity the trade laws to allow the carriage of no as MARAD–2018–0145 at http:// more than twelve passengers for hire on basis for any such claim and, if possible, www.regulations.gov. Interested parties a summary of your submission that can vessels, which are three years old or may comment on the effect this action be made available to the public. more. A request for such a waiver has may have on U.S. vessel builders or been received by MARAD. The vessel, businesses in the U.S. that use U.S.-flag Privacy Act and a brief description of the proposed vessels. If MARAD determines, in service, is listed below. accordance with 46 U.S.C. 12121 and In accordance with 5 U.S.C. 553(c), DATES: Submit comments on or before MARAD’s regulations at 46 CFR part DOT solicits comments from the public October 22, 2018. 388, that the issuance of the waiver will to better inform its rulemaking process. ADDRESSES: You may submit comments have an unduly adverse effect on a U.S.- DOT posts these comments, without identified by DOT Docket Number vessel builder or a business that uses edit, to www.regulations.gov, as MARAD–2018–0145 by any one of the U.S.-flag vessels in that business, a described in the system of records following methods: waiver will not be granted. Comments notice, DOT/ALL–14 FDMS, accessible • Federal eRulemaking Portal: Go to should refer to the vessel name, state the through www.dot.gov/privacy. To http://www.regulations.gov. Search commenter’s interest in the waiver facilitate comment tracking and MARAD–2018–0145 and follow the application, and address the waiver response, we encourage commenters to instructions for submitting comments. criteria given in section 388.4 of provide their name, or the name of their • Mail or Hand Delivery: Docket MARAD’s regulations at 46 CFR part organization; however, submission of Management Facility is in the West 388. names is completely optional. Whether Building, Ground Floor of the U.S. Public Participation or not commenters identify themselves, Department of Transportation. The all timely comments will be fully Docket Management Facility location How do I submit comments? considered. If you wish to provide address is: U.S. Department of Please submit your comments, comments containing proprietary or Transportation, MARAD–2018–0145, including the attachments, following the confidential information, please contact 1200 New Jersey Avenue SE, West instructions provided under the above the agency for alternate submission Building, Room W12–140, Washington, heading entitled ADDRESSES. Be advised instructions. DC 20590, between 9 a.m. and 5 p.m., that it may take a few hours or even Monday through Friday, except on days for your comment to be reflected (Authority: 49 CFR 1.93(a), 46 U.S.C. 55103, 46 U.S.C. 12121) Federal holidays. on the docket. In addition, your Note: If you mail or hand-deliver your comments must be written in English. *** comments, we recommend that you include We encourage you to provide concise Dated: September 17, 2018. your name and a mailing address, an email comments and you may attach address, or a telephone number in the body additional documents as necessary. By Order of the Maritime Administrator. of your document so that we can contact you There is no limit on the length of the T. Mitchell Hudson, Jr., if we have questions regarding your attachments. Secretary, Maritime Administration. submission. Where do I go to read public comments, [FR Doc. 2018–20458 Filed 9–19–18; 8:45 am] Instructions: All submissions received BILLING CODE 4910–81–P must include the agency name and and find supporting information? specific docket number. All comments Go to the docket online at http:// received will be posted without change www.regulations.gov., keyword search to the docket at www.regulations.gov, MARAD–2018–0145 or visit the Docket including any personal information Management Facility (see ADDRESSES for provided. For detailed instructions on hours of operation). We recommend that

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DEPARTMENT OF TRANSPORTATION Washington, DC 20590. Telephone 202– May I submit comments confidentially? 366–9309, Email [email protected]. If you wish to submit comments Maritime Administration SUPPLEMENTARY INFORMATION: As under a claim of confidentiality, you [Docket No. MARAD–2018–0152] described by the applicant the intended should submit three copies of your service of the vessel OCEAN SPIRIT is: complete submission, including the Requested Administrative Waiver of —Intended Commercial Use of Vessel: information you claim to be confidential the Coastwise Trade Laws: Vessel ‘‘Charter-Sailing Lessons’’ business information, to the Department OCEAN SPIRIT; Invitation for Public —Geographic Region Including Base of of Transportation, Maritime Comments Operations: ‘‘California’’ (Base of Administration, Office of Legislation AGENCY: Maritime Administration, DOT. Operations: San Diego, CA) and Regulations, MAR–225, W24–220, ′ 1200 New Jersey Avenue SE, ACTION: Notice. —Vessel Length and Type: 36 sailing catamaran Washington, DC 20590. Include a cover SUMMARY: The Secretary of letter setting forth with specificity the The complete application is available basis for any such claim and, if possible, Transportation, as represented by the for review identified in the DOT docket Maritime Administration (MARAD), is a summary of your submission that can as MARAD–2018–0152 at http:// be made available to the public. authorized to grant waivers of the U.S.- www.regulations.gov. Interested parties build requirements of the coastwise may comment on the effect this action Privacy Act trade laws to allow the carriage of no may have on U.S. vessel builders or In accordance with 5 U.S.C. 553(c), more than twelve passengers for hire on businesses in the U.S. that use U.S.-flag DOT solicits comments from the public vessels, which are three years old or vessels. If MARAD determines, in to better inform its rulemaking process. more. A request for such a waiver has accordance with 46 U.S.C. 12121 and DOT posts these comments, without been received by MARAD. The vessel, MARAD’s regulations at 46 CFR part edit, to www.regulations.gov, as and a brief description of the proposed 388, that the issuance of the waiver will described in the system of records service, is listed below. have an unduly adverse effect on a U.S.- notice, DOT/ALL–14 FDMS, accessible DATES: Submit comments on or before vessel builder or a business that uses through www.dot.gov/privacy. To October 22, 2018. U.S.-flag vessels in that business, a facilitate comment tracking and ADDRESSES: You may submit comments waiver will not be granted. Comments response, we encourage commenters to identified by DOT Docket Number should refer to the vessel name, state the provide their name, or the name of their MARAD–2018–0152 by any one of the commenter’s interest in the waiver organization; however, submission of following methods: application, and address the waiver names is completely optional. Whether • Federal eRulemaking Portal: Go to criteria given in section 388.4 of or not commenters identify themselves, http://www.regulations.gov. Search MARAD’s regulations at 46 CFR part all timely comments will be fully MARAD–2018–0152 and follow the 388. considered. If you wish to provide instructions for submitting comments. Public Participation comments containing proprietary or • Mail or Hand Delivery: Docket confidential information, please contact Management Facility is in the West How do I submit comments? the agency for alternate submission Building, Ground Floor of the U.S. Please submit your comments, instructions. Department of Transportation. The including the attachments, following the (Authority: 49 CFR 1.93(a), 46 U.S.C. 55103, Docket Management Facility location instructions provided under the above 46 U.S.C. 12121) address is: U.S. Department of heading entitled ADDRESSES. Be advised *** Transportation, MARAD–2018–0152, that it may take a few hours or even 1200 New Jersey Avenue SE, West Dated: September 17, 2018. days for your comment to be reflected By Order of the Maritime Administrator. Building, Room W12–140, Washington, on the docket. In addition, your T. Mitchell Hudson, Jr., DC 20590, between 9 a.m. and 5 p.m., comments must be written in English. Monday through Friday, except on We encourage you to provide concise Secretary, Maritime Administration. Federal holidays. comments and you may attach [FR Doc. 2018–20461 Filed 9–19–18; 8:45 am] Note: If you mail or hand-deliver your additional documents as necessary. BILLING CODE 4910–81–P comments, we recommend that you include There is no limit on the length of the your name and a mailing address, an email attachments. address, or a telephone number in the body DEPARTMENT OF TRANSPORTATION of your document so that we can contact you Where do I go to read public comments, if we have questions regarding your and find supporting information? Maritime Administration submission. Go to the docket online at http:// [Docket No. MARAD–2018–0151] Instructions: All submissions received www.regulations.gov., keyword search must include the agency name and MARAD–2018–0152 or visit the Docket Requested Administrative Waiver of specific docket number. All comments Management Facility (see ADDRESSES for the Coastwise Trade Laws: Vessel received will be posted without change hours of operation). We recommend that MISS BROOKE; Invitation for Public to the docket at www.regulations.gov, you periodically check the Docket for Comments including any personal information new submissions and supporting AGENCY: Maritime Administration, DOT. provided. For detailed instructions on material. ACTION: submitting comments, see the section Notice. Will my comments be made available to entitled Public Participation. SUMMARY: The Secretary of the public? FOR FURTHER INFORMATION CONTACT: Transportation, as represented by the Bianca Carr, U.S. Department of Yes. Be aware that your entire Maritime Administration (MARAD), is Transportation, Maritime comment, including your personal authorized to grant waivers of the U.S.- Administration, 1200 New Jersey identifying information, will be made build requirements of the coastwise Avenue SE, Room W23–453, publicly available. trade laws to allow the carriage of no

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more than twelve passengers for hire on may have on U.S. vessel builders or Privacy Act vessels, which are three years old or businesses in the U.S. that use U.S.-flag In accordance with 5 U.S.C. 553(c), more. A request for such a waiver has vessels. If MARAD determines, in DOT solicits comments from the public been received by MARAD. The vessel, accordance with 46 U.S.C. 12121 and to better inform its rulemaking process. and a brief description of the proposed MARAD’s regulations at 46 CFR part DOT posts these comments, without service, is listed below. 388, that the issuance of the waiver will edit, to www.regulations.gov, as DATES: Submit comments on or before have an unduly adverse effect on a U.S.- described in the system of records October 22, 2018. vessel builder or a business that uses notice, DOT/ALL–14 FDMS, accessible ADDRESSES: You may submit comments U.S.-flag vessels in that business, a through www.dot.gov/privacy. To identified by DOT Docket Number waiver will not be granted. Comments facilitate comment tracking and MARAD–2018–0151 by any one of the should refer to the vessel name, state the response, we encourage commenters to following methods: commenter’s interest in the waiver provide their name, or the name of their • Federal eRulemaking Portal: Go to application, and address the waiver organization; however, submission of http://www.regulations.gov. Search criteria given in section 388.4 of names is completely optional. Whether MARAD–2018–0151 and follow the MARAD’s regulations at 46 CFR part or not commenters identify themselves, instructions for submitting comments. 388. all timely comments will be fully • Mail or Hand Delivery: Docket Public Participation considered. If you wish to provide Management Facility is in the West comments containing proprietary or Building, Ground Floor of the U.S. How do I submit comments? confidential information, please contact Department of Transportation. The Please submit your comments, the agency for alternate submission Docket Management Facility location including the attachments, following the instructions. address is: U.S. Department of instructions provided under the above (Authority: 49 CFR 1.93(a), 46 U.S.C. 55103, Transportation, MARAD–2018–0151, heading entitled ADDRESSES. Be advised 46 U.S.C. 12121) 1200 New Jersey Avenue SE, West that it may take a few hours or even *** Building, Room W12–140, Washington, days for your comment to be reflected Dated: September 17, 2018. DC 20590, between 9 a.m. and 5 p.m., on the docket. In addition, your By Order of the Maritime Administrator. Monday through Friday, except on comments must be written in English. Federal holidays. We encourage you to provide concise T. Mitchell Hudson, Jr., Note: If you mail or hand-deliver your comments and you may attach Secretary, Maritime Administration. comments, we recommend that you include additional documents as necessary. [FR Doc. 2018–20460 Filed 9–19–18; 8:45 am] your name and a mailing address, an email There is no limit on the length of the BILLING CODE 4910–81–P address, or a telephone number in the body attachments. of your document so that we can contact you if we have questions regarding your Where do I go to read public comments, submission. and find supporting information? DEPARTMENT OF VETERANS AFFAIRS Instructions: All submissions received Go to the docket online at http:// must include the agency name and www.regulations.gov., keyword search Advisory Committee on Prosthetics specific docket number. All comments MARAD–2018–0151 or visit the Docket and Special-Disabilities Programs; received will be posted without change Management Facility (see ADDRESSES for Notice of Meeting to the docket at www.regulations.gov, hours of operation). We recommend that The Department of Veterans Affairs including any personal information you periodically check the Docket for provided. For detailed instructions on (VA) gives notice under the Federal new submissions and supporting Advisory Committee Act that a meeting submitting comments, see the section material. entitled Public Participation. of the Federal Advisory Committee on Prosthetics and Special-Disabilities FOR FURTHER INFORMATION CONTACT: Will my comments be made available to Bianca Carr, U.S. Department of the public? Programs will be held on October 17, Transportation, Maritime 2018, in Room 530 and on October 18, Yes. Be aware that your entire 2018, in Room 730 at VA Central Office, Administration, 1200 New Jersey comment, including your personal Avenue SE, Room W23–453, 810 Vermont Avenue NW, Washington, identifying information, will be made DC 20420. The meeting will convene at Washington, DC 20590. Telephone 202– publicly available. 366–9309, Email [email protected]. 8:30 a.m. on both days, and will adjourn May I submit comments confidentially? at 4:30 p.m. on October 17 and at 12 SUPPLEMENTARY INFORMATION: As noon on October 18. This meeting is described by the applicant the intended If you wish to submit comments open to the public. service of the vessel MISS BROOKE is: under a claim of confidentiality, you The purpose of the Committee is to —Intended Commercial Use of Vessel: should submit three copies of your advise the Secretary of VA on VA’s ‘‘Sportfishing and sightseeing complete submission, including the prosthetics programs designed to charter.’’ information you claim to be confidential provide state-of-the-art prosthetics and —Geographic Region Including Base of business information, to the Department the associated rehabilitation research, Operations: ‘‘Oregon’’ (Base of of Transportation, Maritime development, and evaluation of such Operations: Brookings, Oregon’’ Administration, Office of Legislation technology. The Committee also —Vessel Length and Type: 28′ and Regulations, MAR–225, W24–220, provides advice to the Secretary to serve Aluminum hull cabin boat 1200 New Jersey Avenue SE, Veterans with spinal cord injuries, The complete application is available Washington, DC 20590. Include a cover blindness or visual impairments, loss of for review identified in the DOT docket letter setting forth with specificity the extremities or loss of function, deafness as MARAD–2018–0151 at http:// basis for any such claim and, if possible, or hearing impairment, and other www.regulations.gov. Interested parties a summary of your submission that can serious incapacities in terms of daily life may comment on the effect this action be made available to the public. functions.

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On October 17, the Committee will however, members of the public may Desk as a part of the clearance process. receive briefings on Ethics; Audiology direct questions or submit written Therefore, you should allow an and Speech Pathology Services; Blind statements for review by the Committee additional 30 minutes before the Rehabilitation Service; Pain in advance of the meeting to Judy meeting begins. Any member of the Management; Prosthetic and Sensory Schafer, Ph.D., Designated Federal public wishing to attend the meeting Aids Service; and the Comprehensive Officer, Veterans Health Administration, should contact Dr. Schafer at (202) 461– Addiction and Recovery Act (CARA). Patient Care Services, Rehabilitation 7315. On October 18, the Committee members and Prosthetic Services (10P4R), VA, Dated: September 17, 2018. will receive briefings from National 810 Vermont Avenue NW, Washington, Veterans Sports Programs and Special LaTonya L. Small, DC 20420, or by email at Judy.Schafer@ Events; Recreation Therapy Service; and Federal Advisory Committee Management va.gov. Because the meeting is being Rehabilitation Technology Update. Officer. No time will be allocated for receiving held in a Government building, a photo [FR Doc. 2018–20475 Filed 9–19–18; 8:45 am] oral presentations from the public; I.D. must be presented at the Guard’s BILLING CODE 8320–01–P

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Part II

Department of Health and Human Services

Centers for Medicare & Medicaid Services 42 CFR Parts 403, 416, 418, et al. Medicare and Medicaid Programs; Regulatory Provisions To Promote Program Efficiency, Transparency, and Burden Reduction; Proposed Rule

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DEPARTMENT OF HEALTH AND For information on viewing public I. Executive Summary and Background comments, see the beginning of the HUMAN SERVICES A. Purpose SUPPLEMENTARY INFORMATION section. Centers for Medicare & Medicaid Over the past several years, we have FOR FURTHER INFORMATION CONTACT: Services revised the Conditions of Participation Alpha-Banu Wilson, (410) 786–8687. (CoPs) and Conditions for Coverage 42 CFR Parts 403, 416, 418, 441, 460, We have also included a subject matter (CfCs) to reduce the regulatory burden 482, 483, 484, 485, 486, 488, 491, and expert under the ‘‘Provisions of the on providers and suppliers while 494 Proposed Rule’’ section for each preserving health and safety. We provision set out in the proposed rule. [CMS–3346–P] identified obsolete and burdensome SUPPLEMENTARY INFORMATION: Inspection regulations that could be eliminated or RIN 0938–AT23 of Public Comments: All comments reformed to improve effectiveness or received before the close of the reduce unnecessary reporting Medicare and Medicaid Programs; comment period are available for requirements and other costs, with a Regulatory Provisions To Promote viewing by the public, including any particular focus on freeing up resources Program Efficiency, Transparency, and personally identifiable or confidential that health care providers, health plans, Burden Reduction business information that is included in and States could use to improve or AGENCY: Centers for Medicare & a comment. We post all comments enhance patient health and safety. We Medicaid Services (CMS), HHS. received before the close of the also examined policies and practices not ACTION: Proposed rule. comment period on the following codified in rules that could be changed website as soon as possible after they or streamlined to achieve better SUMMARY: This proposed rule would have been received: http:// outcomes for patients while reducing reform Medicare regulations that are www.regulations.gov. Follow the search burden on providers and suppliers of identified as unnecessary, obsolete, or instructions on that website to view care, and we identified non-regulatory excessively burdensome on health care public comments. changes to increase transparency and to providers and suppliers. This proposed become a better business partner. In rule would increase the ability of health Table of Contents addition, the Centers for Medicare & care professionals to devote resources to To assist readers in referencing Medicaid Services (CMS) and the improving patient care by eliminating or sections contained in this preamble, we Department of Health and Human reducing requirements that impede are providing a Table of Contents. Services (HHS) have reaffirmed their quality patient care or that divert commitment to the vision of creating an resources away from furnishing high I. Executive Summary and Background environment where agencies quality patient care. A. Purpose incorporate and integrate the ongoing B. Summary of Major Provisions retrospective review of regulations into DATES: To be assured consideration, C. Summary of Costs and Benefits Department operations to achieve a comments must be received at one of II. Provisions of the Proposed Regulations the addresses provided below, no later A. Religious Nonmedical Health Care more streamlined and effective than 5 p.m. on November 19, 2018. Institutions (RNHCIs)—Discharge regulatory framework. The objectives ADDRESSES: In commenting, please refer Planning (§ 403.736(a) and (b)) were to improve the quality of existing to file code CMS–3346–P. Because of B. Ambulatory Surgical Centers regulations consistent with statutory staff and resource limitations, we cannot C. Hospice requirements; streamline procedural accept comments by facsimile (FAX) D. Hospitals solutions for businesses to enter and transmission. E. Transplant Centers operate in the marketplace; maximize Comments, including mass comment F. Home Health Agencies net benefits (including benefits that are submissions, must be submitted in one G. Comprehensive Outpatient difficult to quantify); and reduce costs Rehabilitation Facility (CORF)— and other burdens on businesses to of the following three ways (please Utilization Review Plan (§ 485.66) choose only one of the ways listed): comply with regulations. H. Critical Access Hospitals In accordance with these goals, we 1. Electronically. You may submit I. Community Mental Health Center electronic comments on this regulation published three final rules that (§ 485.914(d)) identified unnecessary, obsolete, or to http://www.regulations.gov. Follow J. Portable X-Ray Services (§ 486.104(a) and the ‘‘Submit a comment’’ instructions. 486.106(a)) excessively burdensome regulations on 2. By regular mail. You may mail K. Rural Health Clinics (RHCs) and health care providers, suppliers, and written comments to the following Federally Qualified Health Centers beneficiaries. These rules further address ONLY: Centers for Medicare & (FQHCs) increased the ability of health care Medicaid Services, Department of L. Emergency Preparedness for Providers professionals to devote resources to Health and Human Services, Attention: and Suppliers improving patient care by eliminating or CMS–3346–P, P.O. Box 8010, Baltimore, III. Collection of Information Requirements reducing requirements that impede MD 21244–1810. IV. Response to Comments quality patient care or that divert Please allow sufficient time for mailed V. Regulatory Impact Analysis providing high quality patient care: comments to be received before the A. Statement of Need • ‘‘Reform of Hospital and Critical close of the comment period. B. Overall Impact Access Hospital Conditions of 3. By express or overnight mail. You C. Sources of Data Used in Estimates of Participation’’, published May 16, 2012 Burden Hours and Cost Estimates may send written comments to the (77 FR 29034); D. Anticipated Effects • following address ONLY: Centers for E. Alternatives Considered ‘‘Regulatory Provisions to Promote Medicare & Medicaid Services, F. Uncertainty Program Efficiency, Transparency, and Department of Health and Human G. Accounting Statement and Table Burden Reduction’’, published May 16, Services, Attention: CMS–3346–P, Mail H. Reducing Regulation and Controlling 2012 (77 FR 29002) and; Stop C4–26–05, 7500 Security Regulatory Costs • ‘‘Regulatory Provisions to Promote Boulevard, Baltimore, MD 21244–1850. I. Conclusion Program Efficiency, Transparency, and

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Burden Reduction; Part II’’, published found at https://www.regulations.gov/ obsolete, duplicative, or that contain May 12, 2014 (79 FR 27105). docket?D=CMS-2017-0084. unnecessary requirements, as follows. This proposed rule is a continuation • CY 2018 Home Health Prospective 1. Proposals That Simplify and of our efforts to reduce regulatory Payment System Rate Update; Value- Streamline Processes burden and is in accordance with the Based Purchasing Model; and Quality January 30, 2017 Executive Order Reporting Requirements found at a. Discharge Planning in Religious ‘‘Reducing Regulation and Controlling https://www.regulations.gov/ Nonmedical Health Care Institutions Regulatory Costs’’ (Executive Order docket?D=CMS-2017-0100. (RNHCIs) • 13771). We propose changes to the FY 2018 Hospice Wage Index and We have concluded that a more current requirements, CoPs, and Payment Rate Update and Hospice condensed and flexible process for Conditions for Coverage (CfCs) that will Quality found at https:// discharge planning for RNHCIs would simplify and streamline the current www.regulations.gov/ reduce burden and simplify the regulations and thereby increase document?D=CMS-2017-0062-0001. discharge process for patients. • provider flexibility and reduce FY 2018 Hospital Inpatient Specifically, we propose to revise the excessively burdensome regulations, Prospective Payment System for Acute requirements at 42 CFR 403.736(a), while also allowing providers to focus Care Hospitals and the Long-Term Care requiring an evaluation, and on providing high-quality healthcare to Hospital Prospective Payment System § 403.736(b), requiring a discharge plan. their patients. This proposed rule will RFI, found at https:// Instead of specifying detailed discharge also reduce the frequency of certain www.regulations.gov/docket?D=CMS- processes, we would simply require required activities and, where 2017-0055. RNHCIs to assess the need for a • appropriate, revise timelines for certain CY 2018 Hospital Outpatient PPS discharge plan for any patient identified requirements for providers and Policy Changes and Payment Rates and as likely to suffer adverse consequences suppliers and remove obsolete, Ambulatory Surgical Center Payment if there is no plan, and provide duplicative, or unnecessary System Policy Changes and Payment discharge instructions to the patient and requirements. Ultimately, these Rates found at https:// the patient’s caregiver as necessary proposals balance patient safety and www.regulations.gov/docket?D=CMS- when the patient is discharged home. quality, while also providing broad 2017-0091. regulatory relief for providers and • FY 2018 Inpatient Rehabilitation b. Ambulatory Surgical Center (ASC): suppliers. Facility Prospective Payment System Transfer Agreements With Hospitals We seek to reduce burdens for health found at https://www.regulations.gov/ We propose to remove the care providers and patients, improve the document?D=CMS-2017-0059-0002. requirements at 42 CFR 416.41(b)(3), quality of care, decrease costs, and • FY 2018 Inpatient Psychiatric ‘‘Standard: Hospitalization.’’ This ensure that patients and their providers Facilities Prospective Payment System would address the competition barriers and physicians are making the best found at https://www.regulations.gov/ that currently exist in some situations health care choices possible. Therefore, document?D=CMS-2018-0053-0002. where hospitals providing outpatient we are soliciting public comments on • CY 2018 Revisions to Payment surgical services refuse to sign written additional regulatory reforms for burden Policies under the Physician Fee transfer agreements or grant admitting reduction in future rulemaking. Schedule and Other Revisions to Part B privileges to physicians performing Specifically, we are seeking public found at https://www.regulations.gov/ surgery in an ambulatory surgical center comment on additional proposals or docket?D=CMS-2017-0092. (ASC). The Emergency Medical modifications to the proposals set forth • FY 2018 Prospective Payment Treatment and Labor Act emergency in this rule that would further reduce System and Consolidated Billing for response regulations would continue to burden on Medicare and Medicaid Skilled Nursing Facilities found at address emergency transfer of a patient participating providers and suppliers https://www.regulations.gov/ from an ASC to a nearby hospital. and create cost savings, while also document?D=CMS-2017-0060-0002. preserving quality of care and patient Public comments on the RFIs can be c. ASC Requirements for health and safety. Consistent with our found by searching for the terms ‘‘RFI’’ Comprehensive Medical History and ‘‘Patients Over Paperwork’’ Initiative, or ‘‘request for information’’ in the Physical Assessment we are particularly interested in any aforementioned 2017 payment We propose to remove the current suggestions to improve existing regulation dockets on requirements at § 416.52(a) and replace requirements, within our statutory www.regulations.gov. them with requirements that defer, to a authority, where they make providing The most useful comments will be certain extent, to the ASC policy and quality care difficult or less effective. those that include data or evidence to operating physician’s clinical judgment We also note that such suggestions support the position, offer suggestions to ensure that patients receive the could include or expand upon to amend specific sections of the appropriate pre-surgical assessments comments submitted in response to existing regulations, or offer particular tailored to the patient and the type of Requests for Information (RFIs) that additions. surgery being performed. We still would were included in the 2017 prospective require the operating physician to payment regulations for most provider B. Summary of Major Provisions document any pre-existing medical types. We refer readers to the public We propose to reduce regulatory conditions and appropriate test results, comments that were submitted in burden on providers and suppliers by in the medical record, which would response to the RFI for the following modifying, removing, or streamlining have to be considered before, during 2017 payment regulations: current regulations that we now believe and after surgery. In addition, we have • End-Stage Renal Disease are excessively burdensome. The retained the requirement that all pre- Prospective Payment System and proposals fall under three categories: (1) surgical assessments include Payment for Renal Dialysis Services Proposals that simplify and streamline documentation regarding any allergies Furnished to Individuals with Acute processes, (2) proposals that reduce the to drugs and biologicals, and that the Kidney Injury, and End-Stage Renal frequency of activities and revise medical history and physical Disease Quality Incentive Program timelines, and (3) proposals that are examination (H&P), if completed, be

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placed in the patient’s medical record unified and integrated Quality integrated QAPI program, the proposed prior to the surgical procedure. Assessment and Performance standard for infection control would Improvement (QAPI) program for all of allow a hospital that is part of a hospital d. Hospice Requirements for Medication its member hospitals after determining system consisting of multiple separately Management that such a decision was in accordance certified hospitals using a system We have concluded that the with all applicable State and local laws. governing body that is legally requirements at 42 CFR 418.106(a)(1), The system governing body is responsible for the conduct of two or related to having on the hospice staff, an responsible and accountable for more hospitals, the system governing individual with specialty knowledge of ensuring that each of its separately body can elect to have a unified and hospice medications, is no longer certified hospitals meets all of the integrated infection control program for necessary for various reasons. Therefore, requirements of this section. Each all of its member hospitals after we propose to remove these separately certified hospital within the determining that such a decision is in requirements. system would have to demonstrate that: accordance with all applicable State and In addition, we propose to replace the The unified and integrated QAPI local laws. The system governing body requirement that hospices provide a program was established in a manner is responsible and accountable for copy of medication policies and that takes into account each member ensuring that each of its separately procedures to patients, families and hospital’s unique circumstances and certified hospitals meets all of the caregivers with a requirement that any significant differences in patient requirements of this section. Each hospices provide information regarding populations and services offered in each separately certified hospital within the the use, storage, and disposal of hospital; and the unified and integrated system must demonstrate that: The controlled drugs to the patient or patient QAPI program would establish and unified and integrated infection control representative, and family. This implement policies and procedures to program is established in a manner that information would be provided in a ensure that the needs and concerns of takes into account each member more user-friendly manner, as each of its separately certified hospitals, hospital’s unique circumstances and determined by each hospice. We believe regardless of practice or location, were any significant differences in patient this could improve patients’ and given due consideration, and that the populations and services offered in each caregivers’ comprehension and unified and integrated QAPI program hospital; the unified and integrated maximize the effectiveness of the would have mechanisms in place to infection control program establishes education effort. ensure that issues localized to particular and implements policies and e. Hospice Requirements: Orientation of hospitals were duly considered and procedures to ensure that the needs and Skilled Nursing Facility (SNF) and addressed. concerns of each of its separately certified hospitals, regardless of practice Intermediate Care Facilities for g. Hospital Requirements for or location, are given due consideration, Individuals With Intellectual Comprehensive Medical History and and that the unified and integrated Disabilities (ICF/IID) Staff Physical Examinations (§§ 482.22, infection control program has 482.24, and 482.51) We propose to move the requirements mechanisms in place to ensure that at § 418.112(f) to the ‘‘Written We propose to allow hospitals the issues localized to particular hospitals agreement’’ standard at new flexibility to establish a medical staff are duly considered and addressed; and § 418.112(c)(10). Moving the policy describing the circumstances a qualified individual (or individuals) requirement for facility staff orientation under which such hospitals could has been designated at the hospital as from a standalone requirement that utilize a pre-surgery/pre-procedure responsible for communicating with the places responsibility solely on hospices assessment for an outpatient, instead of unified infection control program and to the section of the rule related to the a comprehensive medical history and for implementing and maintaining the written agreement established between physical examination (H&P). We believe policies and procedures governing hospices and skilled nursing facilities that the burden on the hospital, the infection control as directed by the (SNFs) and intermediate care facilities practitioner, and the patient could be unified infection control program. for individuals with intellectual greatly reduced by allowing this option. disabilities (ICFs/IID) will allow both In order to exercise this option, a i. Special Requirements for Psychiatric entities to negotiate the terms for hospital would need to document the Hospitals assuring orientation of facility staff. This assessment in a patient’s medical We propose at § 482.61(d) to clarify will give hospices more freedom to record. The hospital’s policy would the scope of authority for non-physician develop innovative approaches and have to consider patient age, diagnoses, practitioners or Doctor of Medicine avoid effort duplication with other the type and number of surgeries and Doctor of Osteopathic Medicine (MD/ hospices that are orienting the same procedures scheduled to be performed, DOs) to document progress notes of facility staff. comorbidities, and the level of patients receiving services in anesthesia required for the surgery or psychiatric hospitals. f. Hospital Quality Assessment and procedure; nationally recognized Performance Improvement Program j. Special Requirement for Transplant guidelines and standards of practice for (QAPI Program) Centers and Definitions assessment of specific types of patients We propose a new standard at 42 CFR prior to specific outpatient surgeries and We are proposing a nomenclature 482.21(f), ‘‘Unified and integrated QAPI procedures; and applicable state and change at part 482 and the transplant program for multi-hospital systems.’’ local health and safety laws. center regulations at §§ 482.68, 482.70, We would allow a hospital that was part 482.72 through 482.104, and at § 488.61. of a hospital system consisting of h. Hospital Infection Control Program This change would update the multiple separately certified hospitals We propose a new standard at terminology used in the regulations to using a system governing body that was § 482.42(c), ‘‘Unified and integrated conform to the terminology that is legally responsible for the conduct of infection control program for multi- widely used and understood within the two or more hospitals, the system hospital systems.’’ Like the proposed transplant community, thereby reducing governing body could elect to have a requirements for a unified and provider confusion.

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k. Data Submission, Clinical Experience, the ordering process for portable x-rays c. Comprehensive Outpatient and Outcome Requirements for Re- and promote the use of more efficient Rehabilitation Facility (CORF) Approval of Transplant Centers ordering methods, such as electronic Utilization Review Plans We propose to remove the orders. We propose to amend the utilization requirements at § 482.82 that require p. Emergency Preparedness transplant centers to submit clinical review plan requirements at § 485.66 to Requirements: Requirements for reduce the frequency of utilization experience, outcomes, and other data in Emergency Plans order to obtain Medicare re-approval. reviews from quarterly to annually. This Transplant centers will still be required We propose to eliminate part of the would allow an entire year to collect to comply with the CoPs at §§ 482.72 requirement from § 482.15(a)(4) for and analyze data to inform changes to through 482.104 and the data hospitals and other parallel provisions the facility and the services provided. submission, clinical experience, and for other affected Medicare and d. Community Mental Health Center outcome requirements for initial Medicaid providers and suppliers (CMHC) Requirements for Updating the Medicare approval under § 482.80. (referred to collectively as ‘‘facilities,’’ Client Assessment l. Special Procedures for Approval and throughout the remainder of this Re-Approval of Organ Transplant proposed rule where applicable), that We propose to remove the Centers facilities document efforts to contact requirement that all Community Mental local, tribal, regional, State, and Federal Health Center (CMHC) clients receive an We propose to remove the emergency preparedness officials, and updated assessment every 30 days. requirements at § 488.61(f) through (h) that facilities document their with respect to the re-approval process Instead, we would require updates of participation in collaborative and the patient assessment in accordance for transplant centers. This change cooperative planning efforts. In corresponds to the proposed removal of with client needs and standards of accordance with the remaining practice. For clients receiving partial the provisions § 482.82. requirement at § 482.15(a)(4), facilities hospitalization services, we propose to would still be required to include a m. HHA Requirements for Verbal retain the 30 day assessment update process for cooperation and Notification of Patient Rights and time frame in accordance with existing Responsibilities collaboration with local, tribal, regional, State and Federal emergency Medicare payment requirements for We propose to remove the partial hospitalization services. requirements for verbal (meaning preparedness officials’ efforts to spoken) notification of patient rights to maintain an integrated response during e. RHC and FQHC Review of Patient those patient rights elements for which a disaster or emergency situation. Only Care Policies the Social Security Act (the Act) the documentation requirements would requires such verbal notification. be eliminated. We propose to revise the requirement at § 491.9(b)(4) that RHC and FQHC Specifically, we propose to only require 2. Proposals That Reduce the Frequency patient care policies are reviewed at verbal notice for those rights related to of Activities and Revise Timelines payments made by Medicare, Medicaid, least annually by a group of professional and other federally funded programs, a. Home Health Agency (HHA) personnel to review every other year to and potential patient financial Requirements for Providing Patients reduce the frequency of policy reviews. With Copies of Clinical Records liabilities. f. RHC and FQHC Program Evaluation n. Personnel Requirements for Portable We propose to remove the X-Ray Technologists requirement that Home Health Agencies We propose to revise the requirement (HHAs) provide a copy of the clinical at § 491.11(a) by changing the frequency We propose to revise § 486.104, record to a patient, upon request, by the of the required RHC or FQHC evaluation ‘‘Condition for coverage: Qualifications, next home visit. We propose to retain from annually to every other year. orientation and health of technical the requirement that the copy of the personnel’’, to align the current g. Emergency Preparedness clinical record must be provided, upon requirements at § 486.104(a)(1), (2), (3), Requirements: Requirements for Annual request, within 4 business days. (4) with § 482.26(c)(2), which refers to Review of Emergency Program qualifications of radiologic technologists b. CAH Annual Review of Policies and in hospitals and is focused on the Procedures On September 16, 2016, we finalized qualifications of the individual a rule imposing emergency performing services. We propose to change the preparedness requirements on most requirement at § 485.635(a)(4) to reflect Medicare and Medicaid facilities o. Portable X-Ray Requirements for the current medical practice where (Emergency Preparedness Requirements Orders providers are expected to update their for Medicare and Medicaid Participating We propose to revise the requirements policies and procedures as needed in Providers and Suppliers, 81 FR 63860). for portable x-ray orders at response to regulatory changes, changes Facilities participating in Medicare and/ § 486.106(a)(2). We propose to remove in the standard of care, or nationally or Medicaid are now required, among the requirement that physician or non- recognized guidelines. The current CoP other things, to review their emergency at § 485.635(a)(4) requires a CAH’s physician practitioner’s orders for preparedness programs annually. This portable x-ray services must be written professional personnel to review its includes a review of their emergency and signed. We also propose to replace policies at least annually and the CAH plans, policies and procedures, the specific requirements related to the to review as necessary. We propose to content of each portable x-ray order reduce burden and provide flexibility by communication plans, and training and with a cross-reference to the requiring the CAH’s, professional testing programs. We propose to revise requirements at 42 CFR 410.32, which personnel, at a minimum, to conduct a these requirements, so that applicable also apply to portable x-ray services. biennial review of its policies and providers and suppliers have increased These proposed changes would simplify procedures instead of an annual review. flexibility with compliance.

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h. Emergency Preparedness hospice. We would defer to State routine and 24-hour emergency dental Requirements: Requirements for licensure requirements regardless of care. Training their content or format, and would d. Home Health Agency Home Health allow states to set forth training and As with the review of the emergency Aide Supervision Requirements plan previously discussed, we propose competency requirements that meet the to revise the requirement that facilities needs of their populations. We believe We propose to revise the requirement develop and maintain a training that this change would streamline the at § 418.76(h) related to completing a program based on the facility’s hiring process for most hospices. full competency evaluation when an emergency plan annually. Instead, we b. Medical Staff: Autopsies aide is found to be deficient in one or would require that facilities provide more skills. Instead of completing a full We propose to remove the training biennially (every 2 years) after competency evaluation, an aide would requirement for hospitals at § 482.22(d), facilities conduct initial training for only be required to complete retraining which states that a hospital’s medical their emergency program. In addition, and a competency evaluation directly staff should attempt to secure autopsies we propose to require additional related to the deficient skills. in all cases of unusual deaths and of training when the emergency plan is medical-legal and educational interest. e. CAH Disclosure Requirements significantly updated. We propose to instead defer to State law i. Emergency Preparedness regarding such medical-legal We propose to remove § 485.627(b)(1), Requirements: Requirements for Testing requirements. the requirement for CAHs to disclose the names of people with a financial For inpatient providers, we propose to c. Hospital and CAH Swing-Bed interest in the CAH. This is currently a expand the types of acceptable testing Requirements requirement under the program integrity exercises that may be conducted such We propose to remove the cross requirements at 42 CFR 420.206, which that one of the two annually required reference to § 483.10(f)(9) at are referenced in the provider agreement testing exercises may be an exercise of § 482.58(b)(1) (for hospital swing-bed rules in 42 CFR 489.53(a)(8). The their choice, which may include one providers) and § 485.645(d)(1) (for CAH provider agreement rules note that the community-based full-scale exercise, if swing-bed providers). The cross- basis for termination of the provider available, an individual facility-based reference gives a resident the right to agreement includes failure of the functional exercise, a drill, or a tabletop choose to, or refuse to, perform services provider to furnish ownership exercise or workshop that includes a for the facility if they so choose. If the information as required in § 420.206, group discussion led by a facilitator. For resident works, the facility must making this CAH CoP requirement outpatient providers, we propose to document it in the resident’s plan of duplicative of those regulations. revise the requirement such that only care, noting whether the services are one testing exercise is required C. Summary of Costs and Benefits voluntary or paid, and, if paid, annually, which may be either one providing wages for the work being 1. Overall Impact community-based full-scale exercise, if performed, at prevailing rates. available, or an individual facility-based We propose to remove the cross- This proposed rule would create functional exercise, every other year and reference to § 483.24(c) at § 482.58(b)(4) savings and reduce burden in many in the opposite years, these providers (for hospital swing-bed providers) and areas. Several of the proposed changes may chose the testing exercise of their § 485.645(d)(4) (for CAH swing-bed would create measurable monetary choice which may include a providers). This cross reference requires savings for providers and suppliers, community-based full-scale exercise, if that the facility provide an ongoing while others would create less available, a facility-based functional activity program based on the resident’s quantifiable savings of time and exercise, a drill, or a tabletop exercise or comprehensive assessment and care administrative burden. We estimate a workshop that includes a group plan directed by a type of qualified total annual savings of $1,123 million discussion led by a facilitator. professional specified in the regulation. using the midpoints of estimated ranges. 3. Proposals That Are Obsolete, We propose to remove the cross- We also estimate a one-time Duplicative, or That Contain reference to § 483.70(p) at § 482.58(b)(5) implementation cost of $64 million. Unnecessary Requirements (for hospital swing-bed providers) and 2. Section-by-Section Economic Impact § 485.645(d)(5) (for CAH swing-bed Estimates a. Hospice Aide Training and providers requiring facilities with more Competency Requirements than 120 beds to employ a social worker Table 1 summarizes the provisions for We propose to revise § 418.76(a)(1)(iv) on full-time basis). which we are able to provide specific to remove the requirement that a State We propose to remove the cross- estimates for savings or burden licensure program meet the specific reference to § 483.55(a)(1) at reductions (these estimates are training and competency requirements § 482.58(b)(8) (for hospital swing-bed uncertain and could be substantially set forth in § 418.76(b) and (c) in order providers) and § 485.645(d)(8) (for CAH higher or lower, as explained in the for such licensure to qualify a hospice swing-bed providers) requiring that the regulatory impact analysis section of aide to work at a Medicare-participating facility assist residents in obtaining this proposed rule):

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TABLE 1—SUMMARY OF COSTS AND BENEFITS

Estimated Number of annual Provider or supplier type and description of proposed provisions Frequency affected savings entities or benefits ($millions)

Religious Nonmedical Health Care Institution: • Discharge Planning...... As patients are discharged (Esti- 18 (*) mated 619 annual discharges). Ambulatory Surgical Center: • Governing Body and Management ...... Upon failed hospital transfer agree- 5,557 (*) ment attempts. • Patient Admission, Assessment and Discharge (History and Every patient admission to an ASC 1 5,557 454 Physical) **. or hospital outpatient. 2 5,031 • Medical Records ...... Recurring annually ...... 5,557 0 Hospices: • Drugs and Biologicals, Medical Supplies, and Durable Medical Recurring annually ...... 1,151 80 Equipment. • Hospices That Provide Hospice Care to residents of a SNF/NF or Recurring annually ...... 4,602 (*) ICF/IID. • Hospice Aide and Homemaker Services ...... Recurring annually ...... 3,498 2 Hospitals: • Quality Assessment and Performance Improvement Program ...... Recurring annually ...... 5,031 28 • Medical staff: Autopsies ...... Recurring annually ...... 5,031 0 • Infection Control ...... Recurring annually ...... 5,031 105 • Special requirements for hospital providers of long-term care Recurring annually ...... 5,031 30 services (‘‘swing-beds’’). • Special Requirements for Psychiatric Hospitals ...... Recurring annually ...... 574 62 Transplant Programs: • Various provisions related to performance *** ...... Recurring annually ...... 750 (3) Home Health Agencies: • Patient rights ...... Recurring annually ...... 12,624 55 • Home health aide services ...... Recurring annually ...... 12,624 0 • Clinical records ...... Recurring annually ...... 12,624 0 Critical Access Hospitals: • Provision of Services ...... Recurring biennially ...... 1,343 2 • Organizational structure ...... Recurring annually ...... 1,343 (*) • Special requirements for hospital providers of long-term care Recurring annually ...... 1,246 86 services (‘‘swing-beds’’). Comprehensive Outpatient Rehabilitation Facilities: • Utilization Review Plan ...... Recurring annually ...... 188 (*) Community Mental Health Centers: • Assessment Update ...... Recurring annually ...... 52 (*) Portable X-Ray Services: • Qualifications of X-ray technicians *** ...... Annual ...... 500 31 • Removing written orders ...... Annual ...... 500 29 RHC (4,160 clinics) & FQHC (7,874 center locations): • Provision of Services ...... Recurring biennially ...... 12,034 7 • Program Evaluation ...... Recurring biennially ...... 12,034 9 Emergency Preparedness for Providers and Suppliers: • Annual Review of Emergency Preparedness Program ...... Recurring annually ...... 72,844 94 • Emergency Plan ...... Recurring annually ...... 68,254 7 • Training and Testing-Training Program ...... Recurring annually ...... 69,196 33 • Training and Testing-Testing ...... Recurring annually ...... 36,971 9

Total Annual Savings ...... 1,123 Life-extending benefits for transplant patients ** ...... (3) * Amount is less than 1 million dollars. ** These include proposed changes to the following requirements: Special Requirements for Transplant Programs; Data submission, Clinical Experience, and Outcome Requirement for Re-approval of Transplant Programs; and Special Procedures for Approval and Re-Approval of Organ Transplant Programs. *** This estimate is for first full year savings only and will increase in future years. 1 (ACSs). 2 (Hospitals). 3 Not Quantified.

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II. Provisions of the Proposed • An assessment of the possibility of leaves the RNHCI, because doing so is Regulations a patient needing post-RNHCI services not in keeping with the religious tenets and of the availability of those services. and goals of the facility. However, we A. Religious Nonmedical Health Care • An assessment of the probability of believe that it is important to discuss Institutions (RNHCIs)—Discharge a patient’s capacity for self-care or of the with the caregiver at home about a safe Planning (§ 403.736(a) and (b)) possibility of the patient being cared for and healing environment at home and to Section 1861(ss)(1) of the Act defines in the environment from which he or monitor the individual to access any the term ‘‘Religious Nonmedical Health she entered the RNHCI. changes in the patient’s well-being and Care Institution’’ (RNHCI) and lists the • The staff must complete the the need to seek additional care. We requirements that a RNHCI must meet to assessment on a timely basis so that would expect RNHCIs to have policies be eligible for Medicare participation. arrangements for post-RNHCI care are and procedures that address their We have implemented these provisions made before discharge and so that discharge processes. If the RNHCI in 42 CFR part 403, subpart G, unnecessary delays in discharge are determines that a patient either does or ‘‘Religious Nonmedical Health Care avoided. does not require discharge instructions, Institutions Benefits, Conditions of • The discharge planning evaluation this decision must be made based on the Participation, and Payment.’’ Currently must be included in the patient’s care RNHCI’s existing policies. Surveyors there are 18 Medicare-certified RNHCIs record for use in establishing an would be expected to review the RNHCI that are subject to the RNHCI appropriate discharge plan. Staff must policies and confirm that either the regulations. discuss the results of the discharge existence or lack of discharge A RNHCI provides only non-medical planning evaluation with the patient or instructions is consistent with policies items and services through non-medical a legal representative acting on his or established by the RNHCI. nursing personnel on a 24-hour basis. her behalf. We propose a more condensed and These services are provided to • If the discharge planning evaluation flexible process for discharge planning beneficiaries who choose to rely solely indicates a need for a discharge plan, and instructions for RNHCIs. upon a religious method of healing and qualified and experienced personnel Specifically, we propose to remove the for whom the acceptance of medical must develop or supervise the requirements at § 403.736(a) and (b), services would be inconsistent with development of the plan. proposing instead to require RNHCIs to their religious beliefs. ‘‘Religious non- • In the absence of a finding by the provide discharge instructions to the medical care’’ or ‘‘religious method of RNHCI that the beneficiary needs a patient and/or the patient’s caregiver healing’’ means care provided under discharge plan, the beneficiary or his or when the patient is discharged home. established religious tenets that prohibit her legal representative may request a We also propose that paragraphs (c) and conventional or unconventional medical discharge plan. In this case, the RNHCI (d) be redesignated as paragraphs (b) care for the treatment of the patient, and must develop a discharge plan for the and (c). exclusive reliance on religious activity beneficiary. We seek to reduce burdens for health to fulfill a patient’s total healthcare • The RNHCI must arrange for the care providers and patients, improve the needs. The RNHCI does not furnish initial implementation of the quality of care, decrease costs, and medical screening, examination, beneficiary’s discharge plan. ensure that patients and their providers diagnosis, prognosis, treatment, or the • If there are factors that may affect and physicians are making the best administration of drugs or biologicals to continuing care needs or the health care choices possible. Therefore, its patients. appropriateness of the discharge plan, we are soliciting public comments on Section 403.736(a) and (b) of the the RNHCI must reevaluate the additional regulatory reforms for burden RNHCI’s CoPs, as amended in the beneficiary’s discharge plan. The RNHCI reduction for future rulemaking. November 28, 2003 Federal Register (68 must inform the beneficiary or legal Specifically, we are seeking public FR 66710), requires RNHCIs to have a representative about the beneficiary’s comment on additional proposals or discharge planning process for patients. post-RNHCI care requirements. modifications to the proposals set forth We reviewed the current CoPs and • The discharge plan must inform the in this rule that would further reduce payment for RNHCIs at 42 CFR part 403, beneficiary or his or her legal burden on RNHCIs and create cost subpart G, in an effort to reduce burden representative about the freedom to savings, while also preserving quality of and provide flexibility as feasible. As a choose among providers of care when a care and patient health and safety. result of the review, we identified variety of providers is available that are Consistent with our ‘‘Patients Over discharge planning as one area where willing to respect the discharge Paperwork’’ Initiative, we are we could reduce burden. The current preferences of the beneficiary or legal particularly interested in any discharge planning requirements at representative. suggestions to improve existing § 403.736(a) and (b) require RNHCIs to Since the RNHCI’s religious tenets requirements, within our statutory have a discharge planning process that prohibit conventional or authority, where they make providing applies to all patients, and to assure that unconventional medical treatment of a quality care difficult or less effective. appropriate post-institution services are beneficiary, we believe that the We also note that such suggestions obtained for each patient, as necessary. extensive requirements previously could include or expand upon Currently, § 403.736(a)(1) requires discussed are unnecessarily comments submitted in response to the RNHCIs to assess the need for a burdensome, because medical post- FY 2018 Hospital Inpatient Prospective discharge plan for any patient identified institution services are not utilized by Payment System for Acute Care as likely to suffer adverse consequences RNHCI patients. Hospitals and the Long-Term Care if there is no planning and for any other Based on our experience with Hospital Prospective Payment System patient upon his or her request or at the RNHCIs, patients are routinely RFI, found at https:// request of his or her legal representative. discharged to home and not to an acute www.regulations.gov/docket?D=CMS- In accordance with § 403.736, this or post-acute care medical provider or 2017-0055. Public comments on the RFI discharge planning evaluation must be supplier. We do not see a need for can be found by searching for the terms initiated at admission and must include RNHCIs to develop a discharge plan that ‘‘RFI’’ or ‘‘request for information’’ in the following: includes medical care once a patient the aforementioned 2017 payment

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regulation docket on patient hospital transfers. Section patient care or safety. In the absence of www.regulations.gov. 416.41(b)(3)(i) and (ii) requires ASCs to a transfer agreement or admitting The most useful comments will be have a written transfer agreement with privileges, ASCs would continue to those that include data or evidence to a hospital that meets certain Medicare have access to local emergency services support the position, offer suggestions requirements or ensure all physicians to transfer patients to the nearest to amend specific sections of the performing surgery in the ASC have appropriate hospital for continued care. existing regulations, or offer particular admitting privileges in a hospital that Hospitals are required to provide additions. meets certain Medicare requirements. A appropriate screening and stabilizing Contact: Mary Collins, (410) 786– written transfer agreement and treatment for patients experiencing 3189. physician admitting privileges is emergency medical conditions in intended to make sure there is a accordance with the regulations set B. Ambulatory Surgical Centers relationship between the ASC and local forth at § 489.24. Section 416.2 defines an ambulatory hospital that would serve the patient in In light of these factors, we propose to surgical center (ASC) as any distinct the event of a medical emergency. Over remove the requirement for a written entity that operates exclusively for the the past 5 years, we have heard from the hospital transfer agreement or hospital purpose of providing surgical services to largest ASC trade association and physician admitting privileges at patients not requiring hospitalization, in multiple ASCs that we need to address § 416.41(b)(3). We believe the proposed which the expected duration of services the widespread issue of the growing changes to the ASC hospitalization would not exceed 24 hours following an number of hospitals that are declining to standard requirements would streamline admission. The surgical services work with ASCs (either by declining to ASC administrative operations and still performed at ASCs are scheduled, sign a transfer agreement or by declining assure the safety of these services while primarily elective, non-life-threatening to allow admitting privileges to the being less burdensome for Medicare- procedures that can be safely performed hospital by physicians who work in certified ASC facilities. The in an ambulatory setting. Currently, ASCs) due to competition between requirements in § 416.41(b)(1) and (2) there are 5,591 Medicare certified ASCs hospital outpatient surgery departments continue to require the ASC to have an in the United States. and ASCs. CMS has continually worked effective procedure for the immediate Section 1832(a)(2)(F)(i) of the Act with the ASCs and hospitals directly to transfer, to a hospital, of patients specifies that ASCs must meet health, resolve this requirement issue, however, requiring emergency medical care safety, and other requirements specified several facilities have not been able to beyond the capabilities of the ASC and by the Secretary in regulation in order reach a positive outcome. Furthermore, that the hospital must be a local hospital to participate in Medicare. The we have seen no evidence of negative that meets the requirements for payment Secretary of the Department of Health patient outcomes due to a lack of such for emergency services under § 482.2. and Human Services (the Secretary) is transfer agreements and admitting As part of this effective procedure, ASCs responsible for ensuring that the CfCs privileges. Research reports published are not precluded from obtaining a protect the health and safety of all by the ASC Quality Collaborative hospital transfer agreements or hospital individuals treated by ASCs, whether indicate the national hospital transfer physician admitting privileges when they are Medicare beneficiaries or other rate from an ASC to a hospital for care possible. We would also like to solicit patients. is about 1.25 per 1,000 ASC admissions comments on burden that may result from the absence of a transfer agreement The ASC regulations were first (https://www.cms.gov/Medicare/ between ASCs and hospitals. published on August 5, 1982 (47 FR Quality-Initiatives-Patient-Assessment- 34082) and have since been amended Instruments/ASC-Quality-Reporting/ 2. Patient Admission, Assessment and several times. On November 18, 2008, index.html). ASCs are already required Discharge (§ 416.52(a)(1), (2), (3) and (4)) we published a final rule, entitled to have personnel trained and available The current regulations at § 416.52 ‘‘Medicare Program: Changes to the for emergency response when there is a require ASCs to ensure that a physician Ambulatory Surgical Center Conditions patient in the ASC. In addition, the ASC or other qualified practitioner provide a for Coverage’’, (73 FR 68502) revising is expected to provide initial stabilizing comprehensive medical history and four existing health and safety CfCs and treatment until the patient is physical assessment completed not created three new health and safety transferred. Finally, the current more than 30 days before the date of the CfCs. In addition, several other small requirement dates back to 1982, when scheduled surgery. We have received changes have been made in the past ASCs were a newly emerging medical feedback from stakeholders that the several years to amend the emergency care option and there was reasonable current requirement is overly equipment requirements (77 FR 29002) concern as to needed emergency care burdensome for a large majority of and radiologic services requirements being available. healthy patients, specifically those required in the ASCs (79 FR 27106). EMTALA was enacted in 1986 and as patients who are receiving minimally 1. Governing Body and Management its enforcement evolved over time this invasive surgical procedures that are (§ 416.41(b)(3)(i) and (ii)) effectively has rendered such transfer performed under minimal sedation or agreements unnecessary, since local anesthesia alone. For example, Hospitalization Requirements EMTALA imposed requirements on all cataract surgery is the most commonly Section 416.41(b) outlines the patient hospitals to provide emergency care performed ASC surgical procedure hospitalization procedures that ASCs without regard to prior arrangements among Medicare beneficiaries. Modern must have in place to participate in until a patient could be stabilized and, cataract surgery is a short procedure Medicare. Section 416.41(b)(1) states the as appropriate, either discharged using mild sedation and local ASC must have an effective procedure because further care was not necessary, anesthesia. Medical complications for for the immediate transfer, to a hospital, or transferred to another facility or care cataract surgery before, during and after of patients requiring emergency medical arrangement. Therefore, we conclude surgery are extremely rare. Other care that surpass the capabilities of the that these requirements are creating an ophthalmic procedures, such as ASC. Additionally, there are two administrative barrier to efficient ASC Yttrium-Aluminum Garnet (YAG) laser requirements that also pertain to ASC operations without any improvement in capsulotomy, does not require a local

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anesthetic and is a painless 60 second procedure in both eyes, a 31-day delay We would retain the requirement that procedure that can be completed during between the two operations would the physician performing the surgery or a routine patient visit. However, when trigger the need for another physical other qualified practitioner perform a it is performed in an ASC, which examination and, possibly, another set pre-surgical assessment for each ASC enables one laser to be utilized by of laboratory tests. Likewise, if an patient, including documentation multiple surgeons for procedures, the unanticipated event such as a death in regarding any allergies to drugs and requirement for a history and physical the family required delaying a biologicals. We would also retain the is burdensome to the patient and procedure by more than the 30th day requirement that any documentation medical staff without any additional after the examination, a duplicative related to the H&P that may have been benefits. One study published in the examination and any necessary tests performed would be placed in the New England Journal of Medicine would be required. Moreover, if the patient’s medical record prior to the concluded that routine preoperative examination and tests had been surgical procedure. medical testing (blood counts, clotting performed timely, but the results not Our proposed change would simply studies, chemistry panels, transmitted in time, the duplicative eliminate the requirement for a pre- electrocardiograms, chest x-ray, etc.) examination and tests would be operative H&P, while allowing patient- conferred no measurable value in required. specific physician decisions and ASC- reducing adverse medical events on the We propose to remove the current wide policy decisions to determine day of surgery or up to one week requirements at § 416.52(a) and replace what examinations and tests are postoperatively (Schein OD, Katz J, Bass them with requirements that defer to the necessary for each patient. Such EB, et al. Study of Medical Testing for facility’s established policies for pre- decisions could be informed by Cataract Surgery. The value of routine surgical medical histories and physical specialty societies, medical literature, preoperative medical testing before examinations (including any associated past experience, or other factors. We cataract surgery. New England Journal testing) and the operating physician’s believe the proposed changes will of Medicine. 2000; 342(3): 168–75). clinical judgment, to ensure patients reduce burden and provide flexibility Another article on this issue from the receive the appropriate pre-surgical for patients while maintaining a balance Cochrane Database of Systematic assessments that are tailored for the of health and safety requirements for Reviews reviewed three randomized patient and the type of surgery being providers. clinical trials and also found that performed. We propose to require each In reading the discussion that follows, routine preoperative testing did not ASC to establish and implement a it is important to understand that the increase the safety of cataract surgery policy that identifies patients who requirement for making a patient (Keay L, Lindsley K, Tielsch J, Katz J, require an H&P prior to surgery. We assessment at the ASC, on the day of surgery and before surgery commences, and Schein O. Routine preoperative propose that the policy would include remains unchanged. This assessment medical testing for cataract surgery, the time frame for the H&P to be addresses any new surgical risks for the 2012;3:CD007293). These results are completed prior to surgery. ASCs may patient with procedure-specific or consistently found for other ambulatory choose to continue the 30 day policy patient-specific questions (for example, surgeries. For example, one study tested that has existed in regulation since has the patient had a fever in the last 24 over one thousand patients over a wide 2008, or may choose a different time hours or, for a patient with diabetes, range of surgeries and found no increase frame based on available evidence and standards of practice. We propose that have there been any recent changes to in adverse events as a result of no the policy would be required to random blood glucose levels with at- preoperative testing (Chung F, Yuan H, consider the age of patients, their home monitoring?). The questions focus Yin L, Vairavanathan S, and Wong DT. diagnoses, the type and number of on any recent changes or updates to the Elimination of preoperative testing in surgeries that are scheduled to be patient’s condition since the last H&P ambulatory surgery. Anaesth Analg. performed at one time, all known that might adversely impact the 2009 Feb: 108(s):467–75). Another and comorbidities, and the planned level of outcome of the procedure for the much larger study reviewed the anesthesia for the surgery to be patient. This assessment must occur literature on a broad range of performed. ASCs would not be limited before proceeding with the procedure. ambulatory surgeries and examined to these factors, and would be permitted Furthermore, we are not proposing to records of results for over 73,000 to include others to meet the needs of eliminate or discourage comprehensive patients who underwent various hernia their patient populations. Furthermore, pre-surgical H&Ps where warranted. To surgeries and found that preoperative we propose that each ASC’s policy replace the current arbitrary 30-day rule testing was not associated with rates of would be required to follow nationally applying to all patients, regardless of postoperative complications. recognized standards of practice and procedure or risk, we propose that each The vast majority of outpatient guidelines, as well as applicable state facility make an independent surgeries are performed on an outpatient and local health and safety laws. determination as to which procedures or ‘‘ambulatory’’ basis precisely because Particular subgroups of patients may and which patient profiles would they involve extremely low risk of benefit from more extensive and dictate requiring a pre-operative history complications due either to preexisting complete medical history and physical and examination, taken before (but not conditions or to the risk of the surgical assessments prior to surgery. Those necessarily 30 days before and possibly procedure itself. Most such procedures subgroups, for example, might include many months before) the day of surgery. are among those that are also routinely patients who cannot lie supine, have We request comment on whether we performed in physician offices. We chest pain or shortness of breath, have should make exceptions, such as for further note that the specification of any pacemakers, have had a recent heart particular patient conditions or surgical short time period for the acceptability of attack, on dialysis, or take insulin procedures, that should not be entitled pre-surgical evaluations (in other words, (Schein OD, Pronovost PJ. A to such broad discretion, and for any within 30 days) is inherently arbitrary Preoperative Medical History and evidence that would support such and burdensome for the ASC patient Physical Should Not Be a Requirement exceptions. We would also be interested population. For example, in the case of for All Cataract Patients. DOI: 10.1007/ in knowing if particular examinations or a cataract patient who needs a s11606–017–4043–9, March 20, 2017.) tests should be normal for those

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conditions or procedures, and whether Contact: CAPT Jacqueline Leach, shifted. While section 1891(a) of the Act such standards would need be imposed USPHS, 410–786–4282. requires CMS to establish prescriptive by regulation or could rely on physician requirements for aides who provide C. Hospice and facility judgment and practices. services on behalf of home health 1. Hospice Aide and Homemaker agencies, the Act does not establish 3. Medical Records (§ 416.47) Services (§ 418.76) similarly prescriptive requirements for The current regulations at § 416.47 aides who provide services on behalf of require ASCs to maintain complete, Under the current hospice CoP requirements at § 418.76, all hospice hospices. In addition to the hospice aide comprehensive, and accurate medical qualifications that are established in the records to ensure adequate patient care. aides are required to meet specific, federally-established, training and hospice CoPs, hospice aides must also Section 416.47(b) sets out the form and be licensed, certified, or registered by content of the record, including specific education requirements. The requirements are based on the training the State in which they are practicing (if items that must be included in the available), in accordance with the and education requirements for home medical record. To conform to the requirements at § 418.116(a). A hospice health aides as set forth at section proposed changes to the medical history industry association conducted an 1891(a)(3)(D) and 1861(m)(4) of the Act. and physical examination requirements informal survey of all 50 states and Specifically, the current CoPs at § 416.52(a), we propose to revise the found that 76 percent of those states (§ 418.76(a)) require that a hospice aide requirement at § 416.47(b)(2) that states currently have their own hospice aide must be a person who has completed ‘‘Significant medical history and results qualifications for licensure, one of the following: A training program of physical examination’’, by adding ‘‘as certification, or registration. Therefore, and competency evaluation as specified applicable.’’ This proposed revision we assume that in 76 percent of states, in the regulations; a competency would reflect the fact that, in hospice aides are required to meet two accordance with our proposed changes evaluation program that meets the different qualification standards (one for to § 416.52(a), not all ASC patients may requirements specified in the regulation; state licensure, certification, or have a medical history and physical a nurse aide training and competency registration; and one for compliance examination report that would be evaluation program in accordance with with the Federal CoPs). included in the medical record. the requirements set forth in the long This regulatory approach has created We seek to reduce burdens for health term care requirements; or a State unintentional burden during the hiring care providers and patients, improve the licensure program that meets the process for all of the non HHA-based quality of care, decrease costs, and requirements at § 418.76(b) (training) hospices, as well as those HHA-based ensure that patients and their providers and (c) (competency evaluation). At hospices that do not share staff with the and physicians are making the best § 418.76(b) and (c) of the hospice CoPs, home health agency portion of their health care choices possible. Therefore, we specifically detail the content and organization. The unintentional burden we are soliciting public comments on format of aide education, training, and is the result of hospices having to verify additional regulatory reforms for burden of competency evaluations, including during the aide hiring process that the reduction in future rulemaking. the number of classroom and practical applicant meets both the state licensure, Specifically, we are seeking public training hours that must be completed, certification, or registration comment on additional proposals or the skills that must be addressed, and requirements, and also meets the modifications to the proposals set forth the general method (exam or practical specific training and competency in this rule that would further reduce observation) used for assessing requirements set forth in the CoPs. State burden on ASCs and create cost savings, competency in those various skills. requirements may change at any time while also preserving quality of care and We initially proposed and finalized and hospices may receive employment patient health and safety. Consistent these requirements in order to be applications from aides that have been with our ‘‘Patients Over Paperwork’’ consistent with the requirements that trained in another setting such as nurse Initiative, we are particularly interested apply to home health aides (§ 484.80). aide training in the long term care in any suggestions to improve existing Historically, a significant number of environment or private duty aide requirements, within our statutory hospice agencies were HHA-based, training not subject to Federal authority, where they make providing meaning that the same entity provides regulations, so hospices are burdened quality care difficult or less effective. both hospice and home health care with the need to review, in detail, each We also note that such suggestions services, often utilizing the same pool of employment applicant’s training and could include or expand upon staff to furnish both services. Using competency content and format each comments submitted in response to the similar requirements for both hospices time they need to make a new hire. For RFI that was included in the CY 2018 and home health agencies streamlines example, State requirements may OPPS/ASC proposed rule. Public operations for hospices that are home specify a different number of training comments in response to this RFI can be health agency based. Due to the hours to be completed, a different found at the following link: https:// evolution of the hospice industry as a format for assessing competency in a www.regulations.gov/docket?D=CMS- whole, the proportion of HHA-based specific skill, or even a different set of 2017-0091. Public comments on the RFI hospices has significantly declined, mandatory skills in accordance with can be found by searching for the terms reducing the streamlining benefits that State scope of practice requirements. We ‘‘RFI’’ or ‘‘request for information’’ in occur by having the same requirements believe that this is an unnecessary and the aforementioned 2017 payment for aides in both hospice and home inefficient use of hospice staff time that regulation docket on health settings. does not serve to improve patient care www.regulations.gov. As the streamlining benefits for the and safety. The most useful comments will be hospice industry as a whole have To address these concerns, we those that include data or evidence to reduced, the burden/benefit ratio related propose to revise § 418.76(a)(1)(iv) to support the position, offer suggestions to meeting the prescriptive home health remove the requirement that a State to amend specific sections of the aide qualification requirements, which licensure program must meet the existing regulations, or offer particular are required to be set forth in regulation specific training and competency additions. by section 1891(a) of the Act, has requirements set forth in § 418.76(b) and

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(c) in order to be deemed an appropriate (§ 418.58). While deferring to state companies to provide drugs and qualification for employment. This requirements for hospice aide pharmacist services to each of their change would defer to State licensure qualifications would likely introduce a patients at a single bundled service rate. requirements, except in states where no new level of variability in the aide These hospices were already realizing requirements exist, regardless of their hiring process, we believe that the the benefits of specialized drug content or format, and would allow remaining hospice CoPs would continue management expertise in the absence of states to set forth training and to assure that hospice aide services meet Federal regulations. Since 2008, the use competency requirements that meet the the needs of patients and families, and of pharmacy benefit management needs of their populations. We do not are delivered in a safe and effective companies, including their built-in believe that it is necessary for the manner. pharmacy experts, has continued to Federal government to oversee the 2. Drugs and Biologicals, Medical grow at a rapid pace. Although there qualifications established by states Supplies, and Durable Medical have been no formal studies on the because these states have already Equipment (§ 418.106(a)(1) and (e)(2)(i)) proliferation of pharmacy benefit demonstrated their willingness and management company use in hospice, The June 5, 2008 Hospice CoP final ability to regulate this area along with conversations with industry experts rule (73 FR 32088) required hospices to federally established requirements. This lead us to estimate that, at minimum, 75 ensure that the interdisciplinary group change would also streamline the hiring percent of existing hospices use such confers with an individual with process for most hospices. We would services. Experts estimate that the more education and training in drug continue to require that hospice aides likely number is between 90 and 95 management as defined in hospice may only perform those skills that are percent of hospices due to various policies and procedures and State law, factors that hospices find to be consistent with the training that the aide who is an employee of or under contract has received (§ 418.76(g)(2)(iv)), and desirable, such as predictable capitated with the hospice to ensure that drugs medication fees and direct to the patient would continue to require that, if an and biologicals meet each patient’s area of concern is verified by the door medication delivery services. Since needs (§ 418.106(a)(1)). This the use of pharmacology experts has hospice during an on-site aide requirement was implemented as a supervision visit, then the hospice must become routine due to the proliferation direct result of public comments that of pharmacy benefit management conduct, and the hospice aide must were submitted in regards to the May complete, a competency evaluation in companies that provide pharmacist 2005 Hospice CoP proposed rule (70 FR services for each patient bundled with accordance with § 418.76(c) and 30840). The May 2005 Hospice CoP drug and biologics supply services, we (h)(1)(iii). We believe that these proposed rule proposed to retain believe that it is no longer necessary to requirements will ensure that aides only longstanding requirements for include a regulatory requirement perform duties for which they are pharmacist involvement in the planning specifically related to the use of a trained and that they perform such and delivery of drugs and biologicals for pharmacology expert. As pharmacy duties in a safe and effective manner. patients that receive care in the hospice benefit management services bundle Furthermore, we would continue to inpatient setting. Commenters suggested drug and biologics supply services with require that hospices must that we broaden our proposal and apply expert advice, and since industry comprehensively assess patients on a it to patients receiving care in all experts estimate that at least 75 percent regular schedule and on an as needed settings. The commenters stated that, basis (§ 418.54(a), (b) and (d)), assure since drugs are prescribed to virtually and as many as 95 percent of hospices that each patient’s plan of care is all hospice patients, these patients use pharmacy benefit management developed and continually updated to should benefit from the expertise of a services for reasons primarily unrelated meet each patient’s needs as identified pharmacist and the additional level of to this specific regulatory requirement, in the assessment process (§ 418.56(b) drug oversight required by the we conclude that the vast majority of through (d)), assure that the plan of care regulatory standards. We agreed with hospices, and thus the vast majority of reflects patient and family goals the commenters that it would be hospice patients, will continue to (§ 418.56(b) and includes all services beneficial to patients to broaden the receive such advice and guidance in the (including aide services) necessary to scope of the pharmacy requirements. absence of regulation. This proposed manage pain and symptoms For this reason, we finalized a change would allow hospices to more (§ 418.56(c)), and ensure that hospice requirement at paragraph (a), ‘‘Managing seamlessly integrate the information care and services are provided in drugs and biologicals,’’ to require that provided by the drug management accordance with the plan of care and are each hospice ensures that the expert into routine interdisciplinary based on all assessments of the patient interdisciplinary group confers with an group meetings rather than having to and family needs (§ 418.56(e)). individual with education and training use burdensome formulaic approaches Furthermore, hospices would continue in drug management as defined in that hospices currently implement in to be required to provide hospice care hospice policies and procedures and order to demonstrate compliance with that optimizes comfort and dignity, and State law, who is an employee of or the regulation. is consistent with patient and family under contract with the hospice to In addition to changes in the needs and goals (§ 418.100(a)). Finally, ensure that drugs and biologicals meet pharmacy benefit management hospices would continue to be required each patient’s needs. Hospices have the landscape, there have also been to maintain an effective, ongoing, option of using a licensed pharmacist or significant changes in the hospice and hospice-wide data-driven quality an individual who has an extensive and palliative care nursing and physician assessment and performance up-to-date knowledge of drugs, to fulfill landscapes. Since publication of the improvement program that involves all this role. 2008 Hospice CoP final rule (73 FR hospice services, including aide At the time when this requirement 32088), the number of hospice and services, that focuses on indicators was finalized in 2008, we estimated that palliative care nursing and physician related to improved patient outcomes, 1,600 hospices (56 percent of all specialty training and certification and takes actions to demonstrate hospices) were already contracting with programs has rapidly expanded. As improvement in hospice performance pharmacy benefit management more hospice and palliative care

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nursing and physician specialists have the family in a language and manner and other otherwise translating the entered the job market, more hospices that they understand to ensure that policies and procedures into layperson’s are employing these clinicians with these parties are educated regarding the terms. This would create more advanced skill sets. In hospices that do safe use and disposal of controlled efficiency while simultaneously not use a pharmacy benefit management drugs; and (3) document in the patient’s improving hospice-patient service, these clinicians typically fill the clinical record that the written policies communications. Hospices would be role of the required individual with and procedures for managing controlled free to choose the content and format(s) education and training in drug drugs was provided and discussed. We that best suits their needs and the needs management in addition to being the believe that the hospice, as well as the of their patient population. We propose regular physician or nurse member of patient, family, and caregivers share the to require that, regardless of the format the interdisciplinary group. As these responsibility and accountability for chosen, this information must be clinicians are already members of the maintaining controlled substances in provided to patients and families in a core interdisciplinary group in the home. We believe that hospices manner that allows for continual access accordance with the requirements at must assume responsibility to educate to the information on an as-needed basis § 418.56(a), we believe that hospices the patient and family about the proper in order to assure that patients and will continue to benefit from their use and disposal of controlled drugs and families have information available expertise in the absence of Federal biologicals that are maintained in the when they need it. CMS is soliciting regulations. For these reasons, we home environment. The drug policies input concerning what a standardized conclude that the requirements at and procedures also help the hospice educational format should entail, § 418.106(a)(1) are no longer necessary explain its own role in controlled drug including whether the format should be to assure patient safety and the management. paper or electronic; in writing, pictorial, effectiveness of hospice care. We believe that this requirement video, or audio; what general subjects Furthermore, we believe that hospices continues to be relevant, particularly in should be addressed in regards to may achieve a cost savings upon relationship to implementing proper storage, disposal, use, and risks; and removal of this requirement because storage and security precautions that what specific content should be they will no longer need to assure a can prevent theft and other drug included to minimize opioid diversion dedicated time in each interdisciplinary diversion in the home, and proper and maximize safety. group meeting in order to be able to disposal when a drug is no longer We would continue to require that document that a specific conversation needed to prevent inappropriate access hospices discuss the information occurred among group members, and and environmental damage. Therefore, regarding the safe use, storage and thus document compliance with the we continue to expect that hospices disposal of controlled drugs with the regulation. Therefore, we propose to would have such policies and patient or representative, and the delete the requirements at procedures for their own internal use as family, in a language and manner that § 418.106(a)(1). part of routine business practice. they understand to ensure that these Hospices would continue to be However, hospice policies and parties are effectively educated. This required to comprehensively assess procedures are typically written in ways requirement is included in the current patients on a regular schedule and on an that are not easily understood by the hospice CoPs and is consistent with as needed basis (§ 418.54(a), (b) and (d)), general public. Hospice clinicians spend Department of Health and Human and to assure that each patient’s plan of more time than expected explaining Services guidance regarding Title VI of care is developed and continually technical terms and otherwise the Civil Rights Act (‘‘Guidance to updated to meet each patient’s needs as translating the policies and procedures Federal Assistance Recipients Regarding identified in the assessment process into layperson’s terms. We do not Title VI Prohibition Against National (§ 418.56(b) through (d)). To the extent believe that this process of explaining Origin Discrimination Affecting Limited that a hospice needs additional expert complex documents in a manner that is English Proficient Persons,’’ 68 FR information or expertise beyond what is meaningful to patients and families is 47311, August 8, 2003, https:// provided by hospice employees and the beneficial to patients, families, www.hhs.gov/civil-rights/for- pharmacy expertise of any pharmacy caregivers, or hospices. individuals/special-topics/limited- benefit manager that a hospice may We propose to replace the english-proficiency/guidance-Federal- choose to use in order to meet a given requirement that hospices provide a financial-assistance-recipients-title-VI/). patient’s assessment, care planning, and physical paper copy of policies and We continue to expect hospices to care delivery medication-related needs, procedures, which are written to guide utilize technology, such as telephonic we would continue to require that it the actions of hospice staff, with a interpreting services and any other secure such information and expertise. requirement that hospices provide available resources for oral Meeting each patient’s needs would information regarding the use, storage, communication in the individual’s continue to be the responsibility of all and disposal of controlled drugs to the primary or preferred language. We Medicare-participating hospices in patient or patient representative, and would also continue to require that accordance with the requirements of all family, which can be developed in a hospices document in the patient’s other hospice CoPs. manner that speaks to the perspectives clinical record that the information was The 2008 Hospice CoP final rule (73 and information needs of patients and provided and discussed. FR 32088) also required hospices, at families. This information would be § 418.106(e)(2)), to: (1) Provide a copy of provided in a more user-friendly 3. Hospices That Provide Hospice Care the hospice written policies and manner, as decided by each hospice, to Residents of a SNF/NF or ICF/IID procedures on the management and which we believe can improve (§ 418.112 (c)(10) and (f)) disposal of controlled drugs to the comprehension and maximize the Section 418.112(f) of the hospice patient or patient representative and effectiveness of the education effort. CoPs, as finalized in the 2008 Hospice family; (2) discuss the hospice policies Furthermore, by providing information CoP final rule (73 FR 32088), requires and procedures for managing the safe in a more user-friendly manner, hospices to assure orientation of Skilled use and disposal of controlled drugs hospices would be able to eliminate Nursing Facility/Nursing Facility (SNF/ with the patient or representative and time spent explaining technical terms NF) or ICF/IID staff furnishing care to

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hospice patients. This orientation is addition, we note that we seek to reduce system believes that its interests are best required to include information burdens for health care providers and served by using a system governing concerning the hospice philosophy, patients, improve the quality of care, body legally responsible for two or more including hospice policies and decrease costs, and ensure that patients hospitals, under the CMS regulations, procedures regarding methods of and their providers and physicians are that system will have the flexibility to comfort, pain control, symptom making the best health care choices do so, just as system that owns two or management, as well as principles about possible. Therefore, we are soliciting more hospitals will have the flexibility death and dying, individual responses public comments on additional to continue with the model of a separate to death, patient rights, appropriate regulatory reforms for burden reduction governing body for each hospital in its forms, and record keeping requirements. in future rulemaking. Specifically, we system if it determines that course The intent of this standard is to ensure are seeking public comment on would best serve its interests. that facility staff who furnish care to additional proposals or modifications to After publication of the May 2012 residents who are hospice patients are the proposals set forth in this rule that final rule, we received a considerable provided information on the hospice would further reduce burden on amount of feedback regarding our philosophy and approach to care, much hospices and create cost savings, while responses in the rule (77 FR 29061) in the same way that home caregivers also preserving quality of care and where we discussed our interpretation are routinely provided information on patient health and safety. Consistent of the Medical staff CoP at § 482.22 as the hospice philosophy and approach to with our ‘‘Patients Over Paperwork’’ requiring that each hospital have its care. It is the hospice’s responsibility to Initiative, we are particularly interested own independent medical staff despite coordinate the trainings with in any suggestions to improve existing the arguable ambiguity of the regulatory representatives of the facility. It is also requirements, within our statutory language. It was brought to our attention the hospice’s responsibility to authority, where they make providing that, over the years, this apparently determine how frequently training quality care difficult or less effective. ambiguous language might have led needs to be offered in order to ensure We also note that such suggestions some stakeholders to interpret § 482.22 that the staff furnishing care to hospice could include or expand upon as allowing for separately certified patients are oriented to the philosophy comments submitted in response to the hospitals, as members of a multi- of hospice care. RFI that was included in the FY 2018 hospital system, to share a unified and We believe that the intent of the Hospice Wage Index and Payment Rate integrated medical staff. This eventually requirement to educate facility staff Update and Hospice Quality Reporting led to us proposing a requirement in a about hospice care continues to be an Requirements. Public comments in February 7, 2013 proposed rule, entitled appropriate regulatory requirement. response to this RFI can be found at the ‘‘Regulatory Provisions To Promote However, we believe that, as currently following link: https:// Program Efficiency, Transparency, and written and implemented, this www.regulations.gov/ Burden Reduction—Part II’’ (78 FR requirement may create duplication document?D=CMS-2017-0062-0001. 9216), which proposed to prohibit the when multiple hospices provide care to Public comments on the RFI can be use of a unified and integrated medical the residents of a single facility. found by searching for the terms ‘‘RFI’’ staff subject to a system governing body. In the May 12, 2014 final rule, Furthermore, by assigning sole or ‘‘request for information’’ in the Medicare and Medicaid Programs; responsibility for this effort to hospice aforementioned 2017 payment Regulatory Provisions To Promote providers, this requirement may impede regulation docket on joint hospice-facility collaboration and Program Efficiency, Transparency, and www.regulations.gov. Burden Reduction (79 FR 27105) that training innovations. Creating The most useful comments will be followed, and after carefully considering duplicative efforts and impeding those that include data or evidence to all of the arguments for and against collaboration may increase hospice support the position, offer suggestions allowing a system that owns two or burden without improving the care of to amend specific sections of the more hospitals to use a unified and hospice patients. Therefore, we believe existing regulations, or offer particular integrated medical staff structure for its that it is appropriate to revise the additions. member hospitals that are subject to a current requirement. Contact: Danielle Shearer, 410–786– Specifically, we propose to remove common system governing body, we 6617. § 418.112(f) and add a new requirement came to the conclusion that it was in the at § 418.112(c)(10), ‘‘Written D. Hospitals best interest of hospitals, medical staff agreement,’’ to address this issue. members, and patients for us to modify 1. Quality Assessment and Performance Moving the requirement for facility staff the proposed prohibition on the use of Improvement Program (§ 482.21) orientation to the standard related to the a unified and integrated medical staff written agreement established between On May 16, 2012, we published a for a multi-hospital system and its hospices and facilities would ensure final rule, entitled ‘‘Reform of Hospital member hospitals so as to enable the that both entities negotiate the and Critical Access Hospital Conditions medical staff of each hospital that is mechanism and schedule for assuring of Participation’’ (77 FR 29034). In that subject to a common system governing orientation of facility staff. Additionally, rule, we finalized changes to the body to voluntarily integrate itself into enabling hospices and facilities to requirements of the ‘‘Governing body’’ a larger system medical staff. negotiate their now shared role would CoP, § 482.12, and adopted a policy to The fact that many hospital systems encourage collaboration between both allow one governing body to oversee had been using a unified medical staff entities, avoid duplication of efforts multiple hospitals in a multi-hospital model for a number of years, without with other hospices that are orienting system. We noted in this rule that the evidence showing that such a model the same facility staff, and provide regulations, as finalized, were intended was detrimental to patients or decreased incentives to facilities to become more to provide systems that own two or the quality of care delivered, was a engaged in the hospice orientation more hospitals with an option, but not major factor in our decision to allow process for facility staff. a requirement, to use a system hospitals and their respective medical We are seeking public comment on all governing body for two or more staffs the flexibility to decide which of the proposed hospice changes. In hospitals. In those instances where a medical staff framework worked best for

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their particular situations. We received one public commenter, writing on Systems,’’ identified specific best a large number of comments from behalf of a multi-hospital system that practices associated with health systems individual physicians as well as the commenter references as the largest (http://www.hpoe.org/Reports-HPOE/ national and State physician in their State, stated that ‘‘we believe highperformance3.2010.pdf). The organizations that supported our the concept of a single medical staff has publication stated that ‘‘due to the size proposed changes to reaffirm and make substantially contributed to our success and breadth of their organizations, more explicit the requirement that each as an integrated delivery system and has multi-hospital health system leaders hospital to have its own medical staff, accelerated our quality, safety and have significant impact on the quality of specifically those hospitals that are part efficiency performance.’’ The health care in the United States. More of a multi-hospital system. These commenter also cited the system’s than half of all U.S. hospitals belong to commenters stated they believe that achievements, which the commenter multi-hospital health systems, and allowing a multi-hospital system to have stated that they believe were a result of about 60 percent of all hospital a unified and integrated medical staff this single and integrated medical staff admissions occurs in system hospitals. instead of separate medical staffs for model: Core measures in the top quartile While a wide range of quality each hospital would destroy the concept with excellent value-based purchasing improvement mechanisms can be of medical staff self-governance that is scores according to CMS; lower in- applied in individual hospitals, there ‘‘a basic requirement’’ for TJC hospital hospital mortality rates that are has been a lack of actionable accreditation and which is ‘‘mandated statistically significant, that is, 17 information that leaders of multi- by some states.’’ Additionally, there percent lower than expected; lower hospital systems can leverage to were some comments from individuals hospital readmission rates that are improve quality across their systems.’’ as well as hospital leaders that stated statistically significant, that is, 15 Therefore, we propose to apply this that while they support the proposed percent lower than expected; and the same level of flexibility and regulatory requirement overall, they believe that second lowest congestive heart failure burden reduction to a hospital’s QAPI there should be some allowance for readmission rate in the nation, program as an option for system hospitals within a system to share according to published CMS data. governing bodies that directly control medical staff bylaws, rules, and Since those rules were published, we and are legally responsible for two or regulations. have not received any negative feedback more separately certified hospitals. As However, these arguments against on the regulatory changes or any with our allowances for system allowing this flexibility through the evidence that the use of a unified governing bodies and unified medical CoPs did not provide any evidence that medical staff model is detrimental to staffs noted previously, we believe that having a single and separate medical patients and their care. And because the system governing bodies that are legally staff for each hospital within a system potential benefits to using such a system responsible for two or more separately was inherently superior, particularly in appear to point to patient safety and certified hospitals should be given the the areas of patient safety and quality of quality of care specifically, we began to flexibility to determine which model of care, to the unified and integrated look at two areas in the CoPs for a QAPI program works best for their medical staff model for two or more possible revision along these lines, two individual member and separately hospitals subject to a system governing areas that we believe have the most certified hospitals. We also believe that, body. We weighed this argument against direct impact on ensuring and in addition to the efficiencies that might the comments from the physician promoting a culture of safety in be gained in the management and leaders and members of unified and hospitals—QAPI and infection control. administration of QAPI programs integrated medical staffs who provided We believe that applying the unified through the increased resources of the testimony and anecdotal evidence for model to a hospital’s QAPI program hospital system, there might also be the benefits of this type of structure. and/or a hospital’s infection control significant improvements in patient Additionally, we considered program would be a natural progression safety and outcomes to be achieved preliminary evidence that appeared to for a multi-hospital system currently through such resources. Allowing for a show that hospitals using a unified using a system governing body and a unified and integrated QAPI program for medical staff might be achieving some unified medical staff. By allowing a its member hospitals would provide a success in reducing Hospital-Acquired system governing body the option of system governing body with the needed Conditions (HACs), Healthcare- unifying and integrating its various flexibility and ease of administration to Associated Infections (HAIs), and member hospital QAPI programs and/or more readily apply the best practices readmissions, and in improving patient infection control programs into unified and innovations learned and developed safety and outcomes. During our programs incorporating each individual at one hospital to other hospitals subject preliminary development of this rule, hospital’s QAPI program and/or to the same system governing body that we carefully considered any additional infection control program (and thus might be facing the same problem-prone areas where we could provide further applying the greater resources of the areas of patient care. We believe that by flexibility and reduce regulatory burden system to each hospital’s QAPI program allowing system governing bodies this for hospitals. We were particularly and/or infection control program), we regulatory option, greater interested in those areas that we had not believe a system might be able to more communication between member considered or proposed in the previous efficiently and effectively disseminate hospitals would be fostered so that a rulemaking efforts discussed. As we innovations, solutions, and best culture of patient safety and quality care noted with regard to the use of a unified practices for patient care to each of its could then be more fully integrated medical staff model under a system member hospitals through these throughout the system. Given this governing body, much of the evidence respective unified programs. The Health flexibility and opportunity for and testimony provided to us at that Research and Educational Trust, in integration, we believe that member time focused on observed improvements partnership with the American Hospital hospitals subject to the same system in patient safety, quality of care, and Association in a March 2010 publication governing body would replace the overall patient outcomes. In the May entitled, ‘‘A Guide to Achieving High approach of each hospital operating 2014 final rule previously referenced, Performance in Multi-Hospital Health within its own ‘‘silo,’’ a still all-too-

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common operating standard, even more than 30 days before or 24 hours patients, as in ASCs) and because these within multi-hospital systems, that after admission or registration, but prior requirements are contained under three thwarts advances and innovations in to surgery or a procedure requiring separate CoPs, any proposed hospital improving patient care across the anesthesia services. The bylaws must requirements for pre-surgical system. also include a requirement that an assessments in lieu of the current We propose a new standard at updated examination of the patient, requirements for a comprehensive H&P § 482.21(f), ‘‘Unified and integrated including any changes in the patient’s would need to be structured somewhat QAPI program for multi-hospital condition, be completed and differently than those proposed for systems’’. We would allow that for a documented within 24 hours after ASCs. However, we are basing certain hospital that is part of a hospital system admission or registration, but prior to aspects of the proposed hospital consisting of two or more separately surgery or a procedure requiring requirements on those proposed for certified hospitals subject to a system anesthesia services, when the H&P are ASCs in order to take into account some governing body legally responsible for completed within 30 days before of the similarities of the two provider the conduct of each hospital, the system admission or registration. These medical types. governing body could elect to have a staff bylaws requirements addressing We would revise the current unified and integrated QAPI program for patient H&Ps form the basis for similar requirements at § 482.22(c)(5)(i) and (ii) all of its member hospitals after requirements in the hospital CoPs at with respect to medical staff bylaws to determining that such a decision is in § 482.24, ‘‘Medical Record Services,’’ allow for an exception under the accordance with all applicable State and and § 482.51, ‘‘Surgical Services.’’ proposed paragraph (c)(5)(iii). We are Current hospital H&P requirements local laws. The system governing body retaining the current language in were proposed and finalized between would be responsible and accountable paragraphs (c)(5)(i) and (ii) that the 2005 and 2007, and similar ASC for ensuring that each of its separately H&P, and any update to it, must be requirements were finalized 1 year later. certified hospitals meets all of the completed and documented by a According to a February 28, 2017, requirements of this section. Each physician (as defined in section 1861(r) Centers for Disease Control and separately certified hospital subject to of the Act), an oromaxillofacial surgeon, Prevention (CDC) National Health the system governing body would have or other qualified licensed individual in Statistics Report (Hall MJ, Schwartzman to demonstrate that: The unified and accordance with State law and hospital A, Zhang J, Liu X. Ambulatory surgery integrated QAPI program was policy. We propose to include this same established in a manner that took into data from hospitals and ambulatory surgery centers: United States, 2010. language regarding who can complete account each member hospital’s unique and document the assessment in the circumstances and any significant National health statistics reports; no. 102. Hyattsville, MD: National Center proposed provision at § 482.22(c)(5)(iii). differences in patient populations and This provision would require the services offered in each hospital; and for Health Statistics. 2017), in 2010, 28.6 million ambulatory surgery visits to medical staff bylaws to state that an the unified and integrated QAPI assessment of the patient (in lieu of the program establishes and implements hospitals and ASCs occurred, with an estimated 48.3 million surgical and requirements of paragraphs (c)(5)(i) and policies and procedures to ensure that (ii)) be completed and documented after the needs and concerns of each of its nonsurgical procedures performed. The report also states that an estimated 25.7 registration, but prior to surgery or a separately certified hospitals, regardless procedure requiring anesthesia services, of practice or location, are given due million (53 percent) ambulatory surgery procedures were performed in hospitals when the patient is receiving specific consideration, and that the unified and outpatient surgical or procedural integrated QAPI program has and 22.5 million (47 percent) were performed in ASCs during this time. services and when the medical staff has mechanisms in place to ensure that chosen to develop and maintain a policy issues localized to particular hospitals Further, the report found that the most frequently performed procedures (for that identifies, in accordance with the are duly considered and addressed. Our both ASCs and hospital outpatient/ requirements at paragraph (c)(5)(v), expectation is that the focus on quality ambulatory surgery departments) specific patients as not requiring a assessment, performance improvement, included endoscopy of large intestine comprehensive medical history and and patient safety within a certified (4.0 million), endoscopy of small physical examination, or any update to hospital that is part of a unified and intestine (2.2 million), extraction of lens it, prior to specific outpatient surgical or integrated QAPI program would be (2.9 million), insertion of prosthetic lens procedural services. The proposed maintained and enhanced through the (2.6 million), and injection of agent into paragraphs (c)(5)(iii) and (iv) would benefits of such integration. spinal canal (2.9 million). These require the medical staff to develop and 2. Medical Staff, Medical Records statistics, which also show similarities maintain a policy that identifies those Services, and Surgical Services between the characteristics of patients patients for whom the assessment (§§ 482.22, 482.24, and 482.51) seen by ASCs and hospital outpatient/ requirements of paragraph (c)(5)(iii) ambulatory surgery departments, would apply. We are also proposing a Hospital Medical History and Physical combined with the evidence already new requirement at paragraph (c)(5)(v) Examination Requirements discussed in section II.B.2, ‘‘Patient for a medical staff that chooses to The current CoP at § 482.22, ‘‘Medical Admission, Assessment and Discharge’’ develop and maintain a policy for the Staff,’’ requires that a hospital have an (§ 416.52(a)(1), (2), (3) and (4)) have led identification of specific patients to organized medical staff that operates us to conclude that we should propose whom the assessment requirements in under bylaws approved by the a less burdensome option for the paragraph (c)(5)(iii) would apply. Under governing body, and which is assessment of a patient prior to a this proposed paragraph, if the medical responsible for the quality of medical hospital outpatient/ambulatory surgery staff exercised the option to perform a care provided to patients by the or procedure for specific patients and simplified assessment in some cases, the hospital. At § 482.22(c)(5), the hospital procedures. written policy would have to indicate medical staff bylaws must include a Because the hospital H&P the specific outpatient surgical or requirement that a H&P be completed requirements apply to all hospital procedural services to which it applied. and documented for each patient no patients (not just ambulatory surgery The policy for each procedure would

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need to indicate the hospital’s must be completed and documented coroner’s or medical examiner’s legal consideration of patient age, diagnoses, within 24 hours after admission or jurisdiction (https://www.cdc.gov/phlp/ the type and number of surgeries and registration when the medical history publications/topic/coroner.html). procedures scheduled to be performed, and physical examination are completed Although the regulations specify that comorbidities, and the level of within 30 days before admission or hospitals should attempt to secure anesthesia required for the surgery or registration. We are revising these permission to perform autopsies in procedure; nationally recognized requirements to allow for an exception certain cases, each state has established guidelines and standards of practice for to them under proposed paragraph specific standards, laws, and regulations assessment of specific types of patients (b)(1)(iii), where we propose a new regarding the performance of autopsies prior to specific outpatient surgeries and requirement that, prior to surgery or a for medical-legal investigative purposes procedures; and applicable State and procedure requiring anesthesia services for hospital patients. According to local health and safety laws. and except in the case of emergencies, CDC’s Public Health Law Program, each In order to make clear that this an assessment of the patient must be State sets its own standards for what proposed requirement would be an completed and documented after kinds of deaths require investigation option that a hospital and its medical registration (and in lieu of the and its own professional and continuing staff could elect to use at their requirements of paragraphs (b)(1)(i) and education requirements for individuals discretion, we propose language that (ii)). This proposed requirement would carrying out these investigations. For states ‘‘the provisions of paragraphs only apply in those instances when the example, the Medicolegal Death (c)(5)(iii), (iv), and (v) do not apply to patient is receiving specific outpatient Investigation system for the state of New a medical staff that chooses to maintain surgical or procedural services and York specifies the use of coroners and a policy that adheres to the when the medical staff has chosen to medical examiners, who have specific requirements of paragraphs (c)(5)(i) and develop and maintain a policy that medical and residency qualifications. (ii) for all patients.’’ In other words, a identifies, in accordance with the Maine’s Medicolegal Death Investigation hospital and its medical staff would be requirements at § 482.22(c)(5)(v), system only specifies the role of a free to exercise their clinical judgment specific patients as not requiring a medical examiner. Unlike the in determining whether a policy for comprehensive medical history and regulations of the individual States, identifying specific patients as not physical examination, or any update to § 482.22(d) does not provide specifics requiring a comprehensive H&P (or any it, prior to specific outpatient surgical or on who should perform an autopsy, nor update to it) prior to specific outpatient procedural services. does it delve into the specifics of the surgical or procedural services, and As we did in the ASC section’s medical-legal investigation process. As instead requiring only a pre-surgical discussion of these proposed changes to with all other CoPs, our intention was assessment for these patients, would be the H&P requirements, we request not to be overly prescriptive or overly their best course. Or, if a hospital and comment on whether there are any burdensome in our requirements. In this its medical staff decided against such a evidence-based exceptions or specific case, the individual States have more policy, then only the current H&P and guidelines, such as for particular patient specific requirements than the CoPs. update requirements (at §§ 482.22, conditions or surgical procedures, that After reexamining this CoP, and in an 482.24, and 482.51) would continue to would prohibit this level of discretion effort to reduce duplicative or apply and the proposed requirements for determining those hospital redundant requirements for hospitals, for this CoP, as well as those proposed outpatient surgery patients who would we believe that it is appropriate to for §§ 482.24 and 482.51, would not not require a comprehensive H&P prior remove the requirement at § 482.22(d). apply. to outpatient surgeries or procedures. We believe that more detailed, specific For the current CoP at § 482.24, Contact: CDR Scott Cooper, USPHS, requirements regarding medical-legal ‘‘Medical Record Services,’’ we would 410–786–9465. investigations and autopsies for revise the provisions at 3. Medical Staff: Autopsies (§ 482.22(d)) hospitals are more appropriately and § 482.24(c)(4)(i)(A) and (B) regarding an more effectively covered by the H&P and its update to allow for an In the June 1986 final rule, Medicare individual State laws in which the exception under proposed paragraph and Medicaid Programs, Conditions of hospital is located. Therefore, we (c)(4)(i)(C) where are proposing to add a Participation for Hospitals (51 FR propose to remove the requirement at new requirement that, if applicable, the 22010), we finalized a regulation to § 482.22(d). However, we continue to medical record would have to document recommend that a hospital’s medical believe that the performance of assessment of the patient (in lieu of the staff attempt to secure autopsies in all autopsies further advances medical requirements of paragraphs (c)(4)(i)(A) cases of unusual deaths and of medical- knowledge. and (B) after registration, but prior to legal and educational interest. Hospitals Contact: Alpha-Banu Wilson, 410– surgery or a procedure requiring are further required to define a 786–8687. anesthesia services, for specific mechanism for documenting permission outpatient surgical or procedural to perform an autopsy, and they must 4. Infection Control (§ 482.42) services. have a system for notifying the medical Similar to our proposal for a unified The current CoP at § 482.51, ‘‘Surgical staff, and specifically the attending and integrated QAPI program for multi- Services,’’ contains provisions at practitioner, when an autopsy is being hospital systems previously discussed, § 482.51(b)(1)(i) and (ii) that require, performed. In that final rule, we stated we believe that the same level of prior to surgery or a procedure requiring that autopsies were an essential flexibility and regulatory burden anesthesia services and except in the educational tool which contributed to reduction can be applied to a hospital’s case of emergencies that a medical the quality of care furnished by a infection control program. We firmly history and physical examination must hospital. Medical-legal investigative believe that the same efficiency of be completed and documented no more autopsies are conducted by a coroner’s administration, and improved patient than 30 days before or 24 hours after or medical examiner’s office to outcomes, patient safety, and quality of admission or registration an updated determine the circumstances under care would be achieved in the infection examination of the patient, including which someone died and combine a control realm through a consistent any changes in the patient’s condition, scientific inquiry into a death under a system-wide approach as would be

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allowed by this proposed rule. Our governing body legally responsible for requirements within the hospital and expectation is that the focus on the conduct of each separately certified CAH CoPs include a subset of cross- infection control within a certified hospital. referenced long-term care requirements hospital that is part of a unified and Contact: CDR Scott Cooper, USPHS, contained in 42 CFR part 483, subpart integrated infection control program 410–786–9465. B, for which hospital and CAH swing- would be maintained and enhanced 5. Special Requirements for Hospital bed providers are surveyed as they are through the benefits of such integration, Providers of Long-Term Care Services for all of the CoPs in their respective and that the trajectory toward continued (‘‘Swing-Beds’’) (§ 482.58(b)(1), (4), (5), programs. The long-term care requirements reductions in infections would be and (8), and Identical CAH under 42 CFR part 483 frequently continued. Requirements: § 485.645(d)(1), (4), (5), Therefore, we propose a new standard reference residents given the average (6), and (7)) at § 482.42(c), ‘‘Unified and integrated length of stay in long-term care facilities infection control program for multi- Section 1883 of the Act permits (28 days for skilled nursing facilities hospital systems.’’ Like the proposed certain small, rural hospitals to enter and 835 days for nursing homes) requirements for a unified and into a swing-bed agreement, under (Medicare Skilled Nursing Facility integrated QAPI program, the proposed which a hospital or CAH can use its (SNF) Transparency Data (CY2013), standard for infection control would beds as needed, to provide either acute https://www.cms.gov/Newsroom/ allow that for a hospital that is part of or SNF care. Swing-beds are beneficial MediaReleaseDatabase/Fact-sheets/ a hospital system consisting of multiple when a patient is ready to leave the 2016-Fact-sheets-items/2016-03- separately certified hospitals subject to acute care level of a hospital stay, but 09.html#; Centers for Disease Control a system governing body legally still requires further skilled nursing and Prevention, Nursing Home Care responsible for the conduct of each care. They are often the only option in FastStats, https://www.cdc.gov/nchs/ hospital, such system governing body rural areas to provide this level of care. data/series/sr_03/sr03_038.pdf). could elect to have a unified and As defined in our regulations, a swing- However, individuals receiving swing- integrated infection control program for bed hospital is a hospital or CAH bed services in a hospital or CAH are all of its member hospitals after participating in Medicare that has CMS receiving SNF services and generally determining that such a decision was in approval to provide post-hospital SNF have shorter length of stays, with an the accordance with all applicable State and care and meets certain requirements. average length of stay of 11.4 days local laws. The system governing body Hospitals providing swing-bed services (Centers for Medicare & Medicaid would be responsible and accountable must meet all of the requirements at 42 Services, Office of Enterprise Data and for ensuring that each of its separately CFR part 482, which includes the Analytics, 2016). Note that this is still certified hospitals met all of the swing-bed requirements at § 482.58 for less than the average 28-day length of requirements of this section. Each patients receiving swing-bed services, stay in a SNF. While we understand that separately certified hospital subject to and CAHs providing swing-bed services some patients receiving swing-bed the system governing body would have must meet all of the requirements at 42 services in a hospital or CAH may have to demonstrate that the unified and CFR part 485, subpart F, which includes longer than average length of stays, we integrated infection control program: (1) the swing-bed requirements at § 485.645 have determined that some of the cross- Was established in a manner that took for patients receiving swing-bed referenced long-term care requirements into account each member hospital’s services. for hospitals and CAH swing-bed unique circumstances and any The hospital CoPs at § 482.58(a)(1) providers are unnecessary and unduly significant differences in patient and (2) specify that hospitals providing burdensome given their focus on populations and services offered in each swing-bed services must be located in a ‘‘residents’’ and longer length of stays. hospital; (2) established and rural area and have less than 100 beds. Thus, we propose to remove the implemented policies and procedures to Section 482.58(a)(1) excludes from the following requirements: ensure that the needs and concerns of count beds for newborns and beds in • §§ 482.58(b)(1) and (c) and each of its separately certified hospitals, intensive care type inpatient units, and 485.645(d)(1) (incorporating long-term regardless of practice or location, are § 482.58(a)(2) requires that the hospital care facility requirements at given due consideration; (3) had be located in rural area, which includes § 483.10(f)(9): Under our current mechanisms in place to ensure that all areas not delineated as ‘‘urbanized’’ regulations at § 483.10(f)(9), the resident issues localized to particular hospitals areas by the Census Bureau, based on has a right to choose to or refuse to are duly considered and addressed; and the most recent census. perform services for the facility, and the (4) designated a qualified individual(s) The CAH CoPs at § 485.645(a)(2) state facility must not require a resident to at the hospital with expertise in that a CAH must not maintain more perform services for the facility. infection prevention and control to be than 25 inpatient beds that may be used Regulations at §§ 482.58(b)(1) and responsible for communicating with the for the provision of inpatient or swing- 485.645(d)(1) incorporate this resident unified infection control program, for bed services, and as required at right by reference. The resident may implementing and maintaining the § 485.635(b)(1)(ii), the CAH must perform services for the facility, if he or policies and procedures governing furnish acute care inpatient services to she chooses. infection control, and for providing patients who present to the CAH for The current requirement for LTCFs infection prevention education and treatment, so long as the CAH has an also states that residents of these training to hospital staff. available inpatient bed and the providers who are receiving swing-bed We are specifically seeking comment treatment required to appropriately care services who choose to perform services on whether there are any other programs for the patient is within the scope of for the facility may do so when the currently required under the CoPs for services offered by the CAH (State facility has documented the need or each separately certified hospital, Operations Manual, Appendix W). desire for the resident to work in the beyond the QAPI and Infection control Hospitals and CAHs must both meet plan of care; the plan specifies the programs proposed here, that eligibility requirements to be granted nature of the services performed and stakeholders believe would likewise be approval from CMS to provide swing- whether the services are voluntary or better managed under a system bed services. The swing-bed paid; compensation for paid services is

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at or above prevailing rates; and the patients receiving swing-bed services in on an outpatient basis. We expect that resident agrees to the work arrangement a hospital or CAH are not long term any required dental services that described in the plan of care. Provided residents of the facility and generally necessitate immediate treatment would that those receiving hospital and CAH only receive swing-bed services for a be considered an emergency and would swing-bed services are not residents and brief period of time for transition after be addressed accordingly. In addition, spend a limited amount of time the provision of acute care services. We the American Dental Association receiving swing-bed services, we have expect that for those patients who recommends that routine dental care be determined that this is an unduly receive swing-bed services for an obtained at least every 6 months, which burdensome requirement. Swing-bed extended period of time, their nursing greatly exceeds that average length of services are transitional SNF-level care plan—as required under stay in a hospital or CAH swing-bed. services provided on a temporary basis. § 482.23(b)(4) for hospitals and However, hospitals and CAHs are As a result, only a limited number of the § 485.635(d)(4) for CAHs—is based on required to provide care in accordance SNF requirements are applicable to assessing the patient’s nursing care with the needs of the patient that have these patients. Therefore, we believe needs and will support care that been identified in such patients’ plans that it is unlikely that patients receiving holistically meets the needs of the of care; this could include non- hospital and CAH swing-bed services patient, taking into consideration emergency dental care. We expect that would be assigned a job and given an physiological and psychosocial factors. hospital swing-bed providers are opportunity to provide services at the • §§ 482.58(b)(5) and 485.645(d)(5) currently addressing the emergent hospital or CAH due to their relatively (incorporating long-term care facility dental care needs of their patients under short length of stay. With the proposed requirements at § 483.70(p)): Any the existing hospital CoP at removal of this requirement, a hospital facility with more than 120 beds must § 482.12(f)(2), which requires that or CAH may permit patients receiving employ a qualified social worker on a hospitals have written policies and swing-bed services to provide services full-time basis. procedures for appraisal of emergencies, at the facility upon mutual agreement We propose to revise the requirements initial treatment, and referral when between the patient and the facility; at §§ 482.58(b)(5) and 485.645(d)(5) for appropriate. Similarly, we expect that thus, we believe that this requirement is hospitals and CAHs. The requirement CAH swing-bed providers are currently unnecessary. We expect hospital and that hospital and CAH swing-bed addressing the emergent dental care CAH swing-bed providers who do offer providers with more than 120 beds needs of their patients under the patients the option of providing services employ a full-time social worker is not existing emergency services CoP at for the facility to have current policies applicable to either provider type. In § 485.618, which requires CAHs to and procedures that reflect this policy accordance with the hospital and CAH provide emergency care necessary to that includes protocol for establishing swing-bed requirements, hospital swing- meet the needs of its inpatients and an agreement between the two parties. bed providers are not permitted to have outpatients. As a result, we believe that In addition, in the absence of these more than 100 beds while CAH swing- this portion of the requirement is requirements, we believe patients’ rights bed providers are not permitted to have duplicative, given the current CoP requirements for hospitals at § 482.13 more than 25 beds for the provision of requirements. and CAHs providing swing-bed services inpatient or swing-bed services. Based Contact: Kianna Banks, 410–786– at § 485.645(d)(3) (which incorporates on feedback from stakeholders, 3498. the long-term care requirements that removing this requirement would eliminate confusion for providers and 6. Special Requirements for Psychiatric patients be free from abuse, neglect and Hospitals (§ 482.61(d)) exploitation) would address such accreditation organizations. situations. We would monitor for any • §§ 482.58(b)(7) and 485.645(d)(7) Section 482.61(d) of our regulations, unintended consequences, as well as (incorporating the long-term care facility as finalized in the June 1986 final rule through evaluation of complaints that requirement at § 483.55(a)(1)): Under (51 FR 22050), requires that progress might be submitted regarding our long-term care facility requirements, notes be documented by the doctor of involuntary work performed by patients the facility, must provide or obtain from medicine (MD) or doctor of osteopathy receiving swing-bed services in an outside resource, in accordance with (DO) responsible for the care of the hospitals and CAHs. We would also § 483.70(g), routine and emergency patient and, when appropriate, others ensure patient protections were dental services to meet the needs of significantly involved in active maintained via the survey process and each resident. We believe that this treatment modalities. ‘‘Others the process used to determine requirement is unnecessary and unduly significantly involved in active allegations of non-compliance with burdensome for hospital and CAH treatment modalities’’ has been Federal or State requirements. swing-bed providers, as patients interpreted as staff from other • §§ 482.58(b)(4) and 485.645(d)(4) receiving swing-bed services in a disciplines, such as rehabilitative (incorporating long-term care facility hospitals or CAHs are not ‘‘generally therapy and psychology, which are requirements at § 483.24(c)): The facility long term residents’’ of the facility and significantly involved in active must provide, based on the are meant to receive swing-bed services treatment modalities and interventions. comprehensive assessment and care for a brief period of time for transition The intent of this requirement is to plan and the preferences of each after the provision of acute care assure that the patient’s medical record resident, an ongoing program to support services. The American Dental contains documentation of the patient’s residents in their choice of activities Association recommends regular dental response to treatment planning and and the activities program must be checkups at least once a year for routine course of treatment. This documentation directed by a qualified professional who dental care for adults over 60 years of also serves to apprise all staff about is a qualified therapeutic recreation age. With an average length of stay in a patient’s progress and any new specialist or an activities professional. hospital or CAH swing-bed of 11.4 days problems or regression. We believe that Similar to the requirements noted and an average daily swing-bed census the intent of the requirement to record previously, we believe that this of 2 patients, we believe that it is progress notes in the patient’s medical requirement is also unnecessary and unlikely that there is a need for routine record continues to be an appropriate burdensome for hospitals and CAHs, as dental services that cannot be provided regulatory requirement. However, we

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believe that as currently written and Public comments on the RFIs can be approval of transplant centers. We also implemented, this requirement requires found by searching for the terms ‘‘RFI’’ placed Medicare-approved transplant clarification. We believe that non- or ‘‘request for information’’ in the centers under the survey and physician practitioners, including aforementioned 2017 payment certification enforcement process we physician assistants, nurse practitioners, regulation dockets on use for all other providers and suppliers psychologists, and clinical nurse www.regulations.gov. of Medicare items and services (72 FR specialists, when acting in accordance The most useful comments will be 15198). The transplant center CoPs with State law, their scope of practice, those that include data or evidence to include data submission, clinical and hospital policy, should have the support the position, offer suggestions experience, outcome, and process authority to record progress notes of to amend specific sections of the requirements for approval and re- psychiatric patients for whom they are existing regulations, or offer particular approval of transplant centers. The responsible. Therefore, we propose to additions. requirements focus on an organ allow the use of non-physician E. Transplant Centers transplant program’s ability to perform practitioners or MD/DOs to document successful transplants and deliver progress notes of patient receiving Transplant programs, located within a quality patient care, as evidenced by services in psychiatric hospitals. transplant hospital that has a Medicare outcomes as well as sound policies and Contact: Kianna Banks, 410–786– provider agreement, provide procedures. The CoPs include transplantation services for a particular 3498. requirements to protect the health and organ type. Transplant programs must We are seeking public comment on all safety of both transplant recipients and comply with the transplant center CoPs, of the proposed hospital changes. In living donors. located at §§ 482.72 through 482.104, addition, we note that we seek to reduce We have continued to review and and with the hospital CoPs. There are burdens for health care providers and analyze the effectiveness of the several types of transplant programs transplant center CoPs, the effects of patients, improve the quality of care, including heart, lung, liver, and kidney. interpretive guidance, and the data decrease costs, and ensure that patients Intestine, pancreas, and multi-organ and their providers and physicians are transplants are performed within derived from surveys of transplant making the best health care choices existing transplant programs. For the programs. We also received comments possible. Therefore, we are soliciting purposes of this discussion, we define a from various stakeholders within the public comments on additional transplant center as a group of transplant center community that regulatory reforms for burden reduction transplant programs that are located in detailed the impacts of the in future rulemaking. Specifically, we a transplant hospital. A transplant implementation of the CoPs on are seeking public comment on program is a component of the transplant programs and transplant additional proposals or modifications to transplant center, within a transplant recipients. Upon further review, and the proposals set forth in this rule that hospital, that provides transplantation taking into account input from various would further reduce burden on for a particular type of organ. Transplant stakeholders, we believe that it is hospitals and create cost savings, while programs are surveyed for compliance appropriate and necessary to revise the also preserving quality of care and with the CoPs. transplant center CoPs in order to patient health and safety. Consistent This proposed rule uses the term reduce provider burden, increase long- with our ‘‘Patients Over Paperwork ‘‘transplant center’’ when discussing the term savings to the Medicare program, Initiative,’’ we are particularly current requirements and language used and eliminate obsolete or unnecessary interested in any suggestions to improve in the regulations. In accordance with requirements, while also continuing to existing requirements, within our our proposed nomenclature change, protect the health and safety of statutory authority, where they make discussed later in this proposed rule, transplant recipients and living donors. providing quality care difficult or less the term ‘‘transplant program’’ is widely Furthermore, we believe that revising effective. We also note that such used throughout the preamble and in the transplant center CoPs will suggestions could include or expand the proposed regulation text. positively impact organ donation and upon comments submitted in response Section 1881(b)(1) of the Act sets out transplantation in the United States by to RFIs that were included in the our authority for the Secretary to increasing the number of transplants following 2017 prospective payment prescribe regulations for facilities performed each year and increasing the regulations for hospitals: furnishing end stage renal disease care organ utilization rate, for reasons we • FY 2018 Hospital Inpatient to beneficiaries, including renal discuss in further detail below. Prospective Payment System for Acute transplant centers. Section 1861(e)(9) of According to the Organ Procurement Care Hospitals and the Long-Term Care the Act permits the Secretary to issue and Transplantation Network (OPTN) Hospital Prospective Payment System regulations for the health and safety of 33,610, organ transplants were found at https://www.regulations.gov/ individuals furnished services in performed and 15,948 donors (both docket?D=CMS-2017-0055. hospitals. living and deceased) provided organs in • CY 2018 Outpatient Prospective In response to the relative scarcity of the United States in 2016. However, as Payment System/Ambulatory Surgical donated organs compared to the number of the writing of this proposed rule, Center proposed rule (https:// of people on transplant waitlists and the 117,104 people still need a lifesaving www.regulations.gov/docket?D=CMS- critical need to use these limited organ transplant in 2017 (number 2017-0091). resources efficiently, we published a represents total waiting list candidates, • FY 2018 Inpatient Rehabilitation final rule that established CoPs for https://optn.transplant.hrsa.gov/, July Facility Prospective Payment System transplant centers on March 30, 2007, 2017). While strides are being made to (https://www.regulations.gov/ (Medicare Program; Hospital Conditions improve organ donation and increase document?D=CMS-2017-0059-0002). of Participation: Requirements for the number of organ transplants in the • FY 2018 Inpatient Psychiatric Approval and Re-Approval of United States, there continues to be a Facilities Prospective Payment System Transplant Centers To Perform Organ shortage of organs. (https://www.regulations.gov/ Transplants) which codified Therefore, we propose to revise the document?D=CMS-2018-0053-0002). requirements for approval and re- transplant center CoPs, as follows:

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1. Special Requirement for Transplant submission, clinical experience, and study found that the 2007 regulations Centers (§§ 482.68 and 482.70) outcome requirements in order to be re- had the effect of altering waitlist Section 482.68 generally describes the approved. In the March 2007 final rule management and clinical decision requirements that a transplant center (72 FR 15198), we also finalized these making, thereby increasing the removal must meet in order to participate in the requirements for initial Medicare of the sickest patients from the waitlist. Medicare program; section § 482.70 sets approval of transplant centers, as The impacts were seen through a 16 out definitions of terms used in the described in § 482.80. Since the percent increase in delisting of patients publication of the final rule, several due to the severity of their illness after regulations. Specifically, in addition to studies have been published that the implementation of the 2007 meeting all the CoPs as a hospital, a examine the impact of these regulation, and likelihood of being transplant center must meet the CoPs requirements on transplantation and delisted continued to increase specified in §§ 482.72 through 482.104 organ utilization in the United States. A thereafter. The authors concluded that in order to be granted approval from 2016 article published in the American the 2007 regulation, which aimed to CMS to provide transplant services. Medical Association Journal of Ethics improve patient outcomes, had the Throughout the regulation, we use concluded that ‘‘using measured consequence of instead failing to show terminology relevant to transplantation outcomes for punitive purposes may any benefit to liver transplant patients. and organ procurement to describe have resulted in significant unintended The authors suggested that future transplant centers, programs, living consequences’’ and that ‘‘transplant national policy decisions consider donors, and transplant center recipients. professionals will, by necessity, adapt rebalance of the waitlist and transplant Because the terminology currently used practice to minimize the risk of outcomes scale (Dolgin, Natasha H. et al. in the regulation is not consistent with regulatory citation and loss of transplant Decade-Long Trends in Liver Transplant current nomenclature used throughout volume’’ which contributes to ‘‘lower Waitlist Removal Due to Illness the transplant community and by the transplant rates (typically among higher- Severity: The Impact of Centers for OPTN, Scientific Registry of Transplant risk candidates)’’ and increased organ Medicare and Medicaid Services Policy. Recipients (SRTR), and the Department discard of marginal organs. (Adler, Joel Journal of the American College of of Health and Human Services (HHS), T. and Axelrod, David A. Regulations’ Surgeons. Volume 222, Issue 6, Pages we propose to update the terminology Impact on Donor and Recipient 1054–1065. DOI: http://dx.doi.org/ within the hospital regulation at part Selection for Liver Transplantation: 10.1016/j.jamcollsurg.2016.03.021, June 482 and the transplant regulations at How Should Outcomes be Measured 2016.). §§ 482.68, 482.70, 482.72 through and MELD Exception Scores be Another study of kidney 482.104, and at § 488.61, for Considered, AMA Journal of Ethics, Vol. transplantation found that most of the clarification and consistency. Volume 18, Number 2: 133–142. Doi: increases in the discard rate from 1988 Specifically, we propose a nomenclature 10.1001/journalofethics.2016.18.02. to 2009 could be explained by recovery change which would: pfor1–1602, February 2016.). of organs from an increasing donor pool • Replace the term transplant Another study linked performance and changes in ‘‘pumping’’ or perfusion ‘‘center’’ in the regulation language with evaluations to transplant volume in practices. ‘‘However, the presence of an transplant ‘‘program’’ (each organ type kidney transplant centers. The authors unexplained, residual increase suggests would be a transplant program). A observed that centers that had low behavioral factors (e.g., increased risk transplant program is located within a performance evaluations were more aversion) . . . may have played a role.’’ transplant hospital that provides likely to have fewer kidney transplants (Darren E. Stewart, et al. Diagnosing the transplantation services for a particular than other kidney transplant centers. Decades-Long Rise in the Deceased type of organ. Since individual The study stated that kidney transplant Donor Kidney Discard Rate in the transplant programs are surveyed for centers that were identified with poor United States. Transplantation. 2017; compliance with the CoPs, using the outcomes ‘‘may be more likely to have 101: 575–587.). term transplant program throughout the staff turnover which may lead to A different approach was taken in a regulation better aligns with current declines in transplant volume’’ and recent study using data from 2000 to surveyor practice and will reduce ‘‘[c]enters that have been evaluated with 2015. This study found that by provider confusion. In order to provide lower performance may generally comparing donors from whom one only further clarity, we are also proposing to become more conservative in overall one kidney was discarded and the other update the definitions at § 482.70. acceptance rates of candidates and was transplanted reasons for discard • Consistently use Independent donor organs’’ (Schold, JD, et al. The could be better assessed. In this study ‘‘a Living Donor Advocate (ILDA) Association of Center Performance large number of discarded kidneys were throughout the regulation. Evaluations and Kidney Transplant procured from donors whose • Change ‘‘beneficiaries’’ to Volume in the United States. American contralateral kidneys were transplanted ‘‘recipients’’. Journal of Transplantation 2013; 13: 67– with good post-transplant outcomes.’’ It Since these changes would make our 75. doi: 10.1111/j.1600– found that when two kidneys were terms consistent with the terminology 6143.2012.04345, 2013.). retrieved from a deceased donor, and utilized by the OPTN and the transplant Another study covering over 90,000 one of the two was discarded and the community, we believe these proposed liver transplant candidates concluded other used in a transplant, it was often changes would reduce provider that the transplant center regulations the case that these ‘‘discarded organs confusion. that were finalized in the March 2007 could have possibly demonstrated final rule (72 FR 15198) increased the excellent performance if transplanted’’ 2. Data Submission, Clinical Experience, likelihood that liver transplant and ‘‘the use of even a fraction of them and Outcome Requirements for Re- candidates would be removed from the could substantially reduce the number Approval of Transplant Centers liver transplant candidate waitlist and of patients who never receive an organ.’’ (§ 482.82) that this policy change led to the sickest As for the cause of these discards, the Section 482.82 requires that patients being increasingly ‘‘denied this authors analyzed several factors and transplant centers that are applying for lifesaving procedure while transplant stated that ‘‘the current report card Medicare re-approval meet all data mortality risks remain unaffected.’’ The system for transplant centers in the

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United States . . . creates a disincentive § 482.102(a)(5) ‘‘Condition of previously. We believe that repeal of to broader organ acceptance for centers participation, Patient and living donor these paragraphs would significantly concerned about payment penalties’’ rights’’ and § 488.61 ‘‘Special reduce transplant programs’ regulatory and that ‘‘realignment of [these] Procedures for Approval and Re- burden by no longer requiring them to incentives to promote more appropriate Approval of Organ Transplant Centers.’’ submit mitigating factors applications or utilization is a key factor in reducing Although we propose to remove these enter into systems improvement discards.’’ (Syed Ali Husain, et al. requirements, we continue to strongly agreements for outcomes non- Characteristics and Performance of believe that transplant programs should compliance (for re-approval surveys, Unilateral Kidney Transplants from focus on maintaining high standards certifications, and enforcement actions Deceased Donors. Clinical Journal that protect patient health and safety for transplant programs). Transplant American Society of Nephrology 13: and produce positive outcomes for programs will continue to be afforded 2018.) transplant recipients. Therefore, we will the opportunity to submit mitigating We also received comments and continue to monitor and assess factors or to enter into transplant feedback from pertinent stakeholders in outcomes, after initial Medicare systems improvement agreements the transplant community that align approval, through the transplant and during the initial application process to with the conclusions of these studies. hospital QAPI programs. In addition, the Medicare program under § 488.61 (f) For instance, UNOS has presented at quality of care will be monitored by through (h). public meetings that up to 1⁄3 of kidneys assessing the other transplant program We seek to reduce burdens for health that are discarded could be successfully CoPs, including §§ 482.72 through care providers and patients, improve the transplanted. Furthermore, the 482.104. We also encourage transplant quality of care, decrease costs, and transplant community has noted that programs and their respective hospitals’ ensure that patients and their providers transplant programs may not use these QAPI programs to conduct thorough and physicians are making the best kidneys due to the perception that they analyses of adverse events, document health care choices possible. Therefore, are of higher risk and that the utilization such events, and implement we are soliciting public comments on of these kidneys may lead to outcomes improvement activities to prevent additional regulatory reforms for burden non-compliance under § 482.82. These recurrences. We further note that reduction in future rulemaking. programs have avoided using these transplant programs must continue to Specifically, we are seeking public kidneys for fear of non-compliance with comply with the CoPs at §§ 482.72 comment on additional proposals or the CoPs and potential Medicare through 482.104 and the data modifications to the proposals set forth termination of the program, despite submission, clinical experience, and in this rule that would further reduce evidence to the contrary that outcome requirements for initial burden on transplant programs and demonstrates that the use of these Medicare approval under § 482.80. We create cost savings, while also kidneys would not pose a problem for believe this proposal will eliminate preserving quality of care and patient transplant recipients. The transplant provider disincentives for performing health and safety. Consistent with our community has therefore concluded that transplantations and will lead to ‘‘Patients Over Paperwork Initiative,’’ the regulations have led to behavioral increased transplantation opportunities we are particularly interested in any changes in organ selection and for patients on the waitlist; improved suggestions to improve existing transplantation on patients with fewer organ procurement for transplantation; requirements, within our statutory comorbidities and lower risk. This has greater organ utilization; lifesaving authority, where they make providing resulted in transplant programs effects, reduced burden on transplant quality care difficult or less effective. potentially avoiding performing programs; and reductions in costs to We also note that such suggestions transplant procedures on certain both public and private insurance. could include or expand upon patients and many organs going unused. We are seeking public comment on comments submitted in response to the While it was our intent to ensure the removal of this requirement. RFI that was included in the FY 2018 quality of care in transplant programs 3. Special Procedures for Approval and Hospital Inpatient Prospective Payment with the implementation of the System for Acute Care Hospitals and the regulations in § 482.82, we acknowledge Re-Approval of Organ Transplant Centers (§ 488.61(f) Through (h)) Long-Term Care Hospital Prospective that the final regulation may have Payment System proposed rule. Public caused unintended consequences that Section 488.61 describes the survey, comments in response to this RFI can be impact transplantation and transplant certification, and enforcement found at the following link: https:// programs in the U.S. Given the findings procedures for transplant centers, www.regulations.gov/docket?D=CMS- of published studies and articles, and including the periodic review of 2017-0055. Public comments on the RFI the public feedback we have received, compliance and approval as set out at can be found by searching for the terms we believe that it is appropriate to § 488.20. Section 488.61(f) through (h) ‘‘RFI’’ or ‘‘request for information’’ in remove these requirements for re- set out the process for our consideration the aforementioned 2017 payment approval of transplant programs in the of a transplant center’s mitigating regulation docket on Medicare program. factors in initial approval and re- www.regulations.gov. Therefore, we propose to remove the approval surveys, certifications, and The most useful comments will be requirements at § 482.82 that require enforcement actions for transplant those that include data or evidence to transplant centers to submit data centers. The provisions also set out support the position, offer suggestions (including, but not limited to, definitions and rules for transplant to amend specific sections of the submission of the appropriate OPTN systems improvement agreements. We existing regulations, or offer particular forms for transplant candidate propose to remove the requirements at additions. registration, transplant beneficiary § 488.61(f) through (h) for mitigating Contact: Alpha-Banu Wilson, 410– registration and follow-up, and living factors and transplant systems 786–8687. donor registration and follow-up), improvement agreements for the re- clinical experience, and outcome approval process for transplant centers. F. Home Health Agencies requirements for Medicare re-approval, This change is complementary to the Home health services are covered for and make conforming changes to proposed removal of § 482.82, described the elderly and disabled under the

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Hospital Insurance (Part A) and with respect to items and services independently establishing and Supplemental Medical Insurance (Part furnished by (or under arrangements enforcing verbal notification B) benefits of the Medicare program, with) the agency, and requirements for all patient rights for and are described in section 1861(m) of • Any changes to the charges or items purposes other than the HHA CoPs, nor the Social Security Act (the Act). These and services set forth in the previous would it prohibit HHAs from providing services, provided under a plan of care bullets. such verbal notification of all patient established and periodically reviewed Section 1891(a)(1)(F) of the Act rights in the absence of Federal by a physician, must be furnished by, or requires that HHAs provide the notice of regulation. Furthermore, this change under arrangement with, a home health patient rights in writing. would not alter the other requirements agency (HHA) that participates in the The requirements at § 484.50(a)(3) at § 484.50(a), which requires HHAs to Medicare or Medicaid programs. implement these statutory requirements, provide the notice of patient rights in Services are provided on a visiting basis and require spoken notice of all patient writing, nor would it alter the in the beneficiary’s home, and may rights, rather than limiting such notice requirements at § 484.50(f), include the following: to those rights specified in the Act. On Accessibility, which requires HHAs to • Part-time or intermittent skilled July 28, 2017, we published a proposed provide information to patients in plain nursing care furnished by or under the rule entitled ‘‘CY 2018 Home Health language and in a manner that is both supervision of a registered professional Prospective Payment System Rate accessible and timely to: (1) Persons nurse. Update; Home Health Value Based with disabilities in accordance with the • Physical therapy, speech-language Purchasing Model; and Home Health Americans with Disabilities Act and pathology, and occupational therapy. Quality Reporting Requirements’’ (82 FR Section 504 of the Rehabilitation Act, • Medical social services under the 35270) that solicited public comments and (2) persons with limited English direction of a physician. on ways to reduce regulatory burden. In proficiency. While HHAs would no • Part-time or intermittent home response to this solicitation, we longer be required to provide a verbal health aide services. received feedback from HHA notification of all patient rights, we • Medical supplies (other than drugs stakeholders that the requirement to would continue to expect that HHAs and biologicals) and durable medical provide verbal notice of all rights to answer any questions from patients or equipment. patients and their representatives was their representatives regarding the • Services of interns and residents if overly burdensome to the HHA content of the written notice of rights. the HHA is owned by or affiliated with clinicians that would be required to We believe that this proposed change a hospital that has an approved medical discuss the notice with patients when would continue to provide adequate residency training program. they could be furnishing hands-on notice to patients while reducing • Services at hospitals, skilled patient care during that time, and lacked burden on HHAs. nursing facilities, or rehabilitation evidence that such explanations would centers when the services involve result in improvements to patient safety 2. Home Health Aide Services equipment too cumbersome to bring to or care. Furthermore, comments (§ 484.80(h)(3)) the home. received encouraged us to reexamine all Section 484.80(h)(3) of the January Under the authority of sections burdens in the January 2017 HHA CoP 2017 HHA CoP final rule (82 FR 4504) 1861(o) and 1891 of the Act, the final rule to weigh potential benefits requires that, when a supervisory visit Secretary has established in regulations against estimated costs. identifies a deficiency in a home health the requirements that an HHA must We believe that the concerns aide’s skills, the HHA must conduct, meet to participate in the Medicare expressed by commenters have merit. In and the aide must complete, a full program. These requirements are set light of this information, we believe that competency evaluation to assess all aide forth in regulations at 42 CFR part 484, any benefits of this requirement are skills and identify any other skill Home Health Services. outweighed by the burdens imposed by deficiencies that were not identified this requirement. For this reason, we while observing the aide performing 1. Patient Rights (§ 484.50(a)(3) and propose to delete the requirement that care with a patient. In public comments (c)(7)) HHAs must provide verbal notification submitted for the July 2017 proposed Section 484.50(a)(3) of the January of all patient rights. This change would rule ‘‘CY 2018 Home Health Prospective 2017 HHA CoP final rule (82 FR 4504), be consistent with the notice of patient Payment System Rate Update’’ (82 FR effective January 13, 2018, requires rights requirements for other outpatient 35270), a commenter suggested that HHAs to provide verbal (meaning provider types, such as hospices, completing a full competency spoken) notice of the patient’s rights ambulatory surgery centers, and evaluation was overly burdensome for and responsibilities in addition to the community mental health centers, for HHAs and aides. Although this requirement to provide such notice in which written notice of patient rights is comment was not submitted during the writing. Section 1891(a)(1)(E) of the Act the only requirement. We propose to proposed rule public comment period requires additional oral notice of rights limit the verbal notification for the HHA CoP proposed rule, we for specified information as follows: requirements to those requirements set believe that the concern expressed by • All items and services furnished by out in section 1891(a)(1)(E) of the Act the commenter has merit. In light of this (or under arrangements with) the agency for which verbal notification is new comment, we reconsidered the for which payment may be made under mandatory. We propose to revise requirement, and concluded that a full Medicare, § 484.50(c)(7) to implement this more competency evaluation is unnecessary • The coverage available for such limited verbal notification requirement. and overly burdensome when only items and services under Medicare, Revised § 484.50(c)(7) would require certain skills have been identified as Medicaid, and any other Federal HHAs to verbally discuss HHA payment deficient. We propose to eliminate the program of which the agency is and patient financial liability requirement to conduct a full reasonably aware, information with each HHA patient as competency evaluation, and replace it • Any charges for items and services described above. with a requirement to retrain the aide not covered under Medicare and any This change would not prevent states regarding the identified deficient skill(s) charges the individual may have to pay or Accrediting Organizations (AOs) from and require the aide to complete a

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competency evaluation related only to authority, where they make providing requirement from a quarterly to an those skills. This targeted retraining and quality care difficult or less effective. annual review would not preclude the competency evaluation requirement We also note that such suggestions CORF from implementing their would reduce the time spent completing could include or expand upon utilization review plan more frequently, competency evaluations and retraining comments submitted in response to the if required by facility policy. We believe efforts. RFI that was included in the CY 2018 that an annual utilization review plan Home Health Prospective Payment will serve as a useful measurement tool 3. Clinical Records (§ 484.110(e)) System Rate Update; Value-Based for the facility, and that the change from In the January 2017 HHA CoPs final Purchasing Model; and Quality quarterly to annual would not rule (82 FR 4504), effective January 13, Reporting Requirements. Public negatively affect patient health and 2018, we finalized a requirement, comments in response to this RFI can be safety. codified at § 484.110(e), that an HHA found at the following link: https:// We seek to reduce burdens for health must make available, upon request, a www.regulations.gov/docket?D=CMS- care providers and patients, improve the copy of the patient’s clinical record at 2017-0100. Public comments on the RFI quality of care, decrease costs, and the next home visit, or within 4 can be found by searching for the terms ensure that patients and their providers business days (whichever comes first). ‘‘RFI’’ or ‘‘request for information’’ in and physicians are making the best In response to the July 2017 proposed the aforementioned 2017 payment health care choices possible. Therefore, rule solicitation of public comment on regulation docket on we are soliciting public comments on burden reduction via the CY 2018 Home www.regulations.gov. additional regulatory reforms for burden Health Prospective Payment System The most useful comments will be reduction in future rulemaking. Rate Update (82 FR 35270), we received those that include data or evidence to Specifically, we are seeking public feedback from HHA stakeholders that support the position, offer suggestions comment on additional proposals or this requirement was impractical for to amend specific sections of the modifications to the proposals set forth HHAs to comply with because existing regulations, or offer particular in this rule that would further reduce providing the record at the next visit additions. burden on CORFs and create cost Contact: Danielle Shearer, 410–786– may not allow enough time for HHAs to savings, while also preserving quality of 6617. create a physical or electronic copy of care and patient health and safety. the clinical record content, provide that G. Comprehensive Outpatient Consistent with our ‘‘Patients Over copy to the next visiting clinician who Rehabilitation Facilities (CORFs)— Paperwork’’ Initiative, we are may not be scheduled to come into the Utilization Review Plan (§ 485.66) particularly interested in any HHA office prior to the visit due to the Section 485.51 of our rules defines a suggestions to improve existing nature of home based care and the Comprehensive Outpatient requirements, within our statutory significant travel that HHA clinicians Rehabilitation Facility (CORF) as a authority, where they make providing must do in order to make patient visits, nonresidential facility that is quality care difficult or less effective. and successfully deliver the copy to the established and operated exclusively for We also note that such suggestions patient. The comments suggested that the purpose of providing diagnostic, could include or expand upon the 4 business day timeline was more therapeutic, and restorative services to comments submitted in response to RFIs practical and is an appropriate outpatients for the rehabilitation of that were included in the 2017 payment regulatory requirement. We agree that injured, disabled, or sick persons, at a regulations. We refer readers to the providing the record at the next visit is single fixed location, by or under the public comments that were submitted in not practical or even possible in some supervision of a physician. As of May response to the RFI for the following cases. Furthermore, we agree that 2017, there were 188 Medicare-certified 2017 payment regulations: retaining the 4 business day timeframe CORFs in the United States. Section • End-Stage Renal Disease is an appropriate regulatory 1861(cc)(2)(G) of the Act requires Prospective Payment System and requirement. Therefore, we propose to CORFs to maintain utilization review Payment for Renal Dialysis Services remove the requirement that the programs. Under this authority, the Furnished to Individuals with Acute requested clinical record copy must be Secretary has established requirements Kidney Injury, and End-Stage Renal provided at the next home visit. at § 485.66 with respect to such Disease Quality Incentive Program We seek to reduce burdens for health programs. Currently, § 485.66 requires found at https://www.regulations.gov/ care providers and patients, improve the the CORF to have in effect a written docket?D=CMS-2017-0084. quality of care, decrease costs, and utilization review plan that is • CY 2018 Home Health Prospective ensure that patients and their providers implemented at least each quarter, to Payment System Rate Update; Value- and physicians are making the best assess the necessity of services and Based Purchasing Model; and Quality health care choices possible. Therefore, promotes the most efficient use of Reporting Requirements found at we are soliciting public comments on services provided by the facility. https://www.regulations.gov/ additional regulatory reforms for burden We propose to amend the utilization docket?D=CMS-2017-0100. reduction. Specifically, we are seeking review plan requirements at § 485.66 to • FY 2018 Hospice Wage Index and public comment on additional proposals reduce the frequency of utilization Payment Rate Update and Hospice or modifications to the proposals set reviews. We believe the requirement to Quality found at https:// forth in this rule that would further implement a utilization review plan 4 www.regulations.gov/ reduce burden on HHAs and create cost times a year is overly burdensome and document?D=CMS-2017-0062-0001. savings, while also preserving quality of diverts staff from providing patient care. • FY 2018 Hospital Inpatient care and patient health and safety. We propose to require the utilization Prospective Payment System for Acute Consistent with our ‘‘Patients Over review plan be implemented annually Care Hospitals and the Long-Term Care Paperwork Initiative,’’ we are by the facility, which would allow an Hospital Prospective Payment System particularly interested in any entire year to collect and analyze data RFI, found at https:// suggestions to improve existing to inform changes to the facility and the www.regulations.gov/docket?D=CMS- requirements, within our statutory services provided. Changing the 2017-0055.

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• CY 2018 Hospital Outpatient PPS requirements of section 1866 of the Act specialists, if they are on staff under the Policy Changes and Payment Rates and (Agreements with Providers of Services; provisions of § 485.631(a)(1). The Ambulatory Surgical Center Payment Enrollment Processes). Providers must policies that are reviewed must include System Policy Changes and Payment meet the terms of the agreement to be the following: Rates found at https:// qualified to participate in the Medicare • A description of the services the www.regulations.gov/docket?D=CMS- program. CAH furnishes, including those 2017-0091. We propose to remove this disclosure furnished through agreement or • FY 2018 Inpatient Rehabilitation requirement from the CAH CoPs as it is arrangement; Facility Prospective Payment System duplicative of requirements for the • Policies and procedures for found at https://www.regulations.gov/ provider agreement. Specifically, emergency medical services; disclosure of individuals with a document?D=CMS-2017-0059-0002. • Guidelines for the medical • FY 2018 Inpatient Psychiatric financial interest in the CAH is a management of health problems that Facilities Prospective Payment System requirement under the provider include the conditions requiring found at https://www.regulations.gov/ agreement rules in § 489.12(a)(2) and medical consultation and/or patient document?D=CMS-2018-0053-0002. must be completed during the provider referral, the maintenance of health care • CY 2018 Revisions to Payment enrollment process. This information must be disclosed on the provider’s records; Policies under the Physician Fee • Schedule and Other Revisions to Part B Medicare enrollment application (Form Rules for the storage, handling, found at https://www.regulations.gov/ CMS–855A for CAHs) and the dispensation, and administration of docket?D=CMS-2017-0092. enrollment application must be updated drugs and biologicals; • • FY 2018 Prospective Payment with any changes, such as address Procedures for reporting adverse System and Consolidated Billing for changes, practice name or change of drug reactions and errors in the Skilled Nursing Facilities found at ownership of information and must be administration of drugs; and https://www.regulations.gov/ submitted to CMS. Also note that this is • A system for identifying, reporting, document?D=CMS-2017-0060-0002. not a requirement in the hospital CoPs investigating and controlling infections Public comments on the RFIs can be under 42 CFR part 482 because it is and communicable diseases of patients found by searching for the terms ‘‘RFI’’ already a requirement in the provider and personnel. or ‘‘request for information’’ in the agreement rules under § 498.12(a)(2). • Procedures that ensure that the aforementioned 2017 payment Contact: Kianna Banks, 410–786– nutritional needs of post-hospital SNF regulation dockets on 3498. inpatients are met in accordance with www.regulations.gov. 2. Provision of Services (§ 485.635(a)(4)) recognized dietary practices. The most useful comments will be Current regulations at § 485.635 Based on feedback from stakeholders, those that include data or evidence to require CAHs to review policies and the prescriptive annual schedule can be support the position, offer suggestions procedures annually. We believe that burdensome or, in some situations, to amend specific sections of the medical practice has evolved such that ineffective. Providers stated that they existing regulations, or offer particular we can provide flexibility for facilities make annual, monthly and biannual additions. to review, correct, or change their changes to their policies. Some have Contact: CAPT Jacqueline Leach, policies and procedures. Based on our stated that they make changes as needed USPHS, 410–786–4282. experience with medical care providers or infrequently. They also stated that the H. Critical Access Hospitals and information from organizations time that it took to review the policies such as the Brookings Institution varied. Some stated it would take as 1. Organizational Structure (https://www.brookings.edu/ little as 2 hours while a few stated a (§ 485.627(b)(1)) testimonies/improving-health-care- much longer period time such as a Current regulations at § 485.627 quality-the-path-forward/), the month, depending on what was being require CAHs to disclose the names and expanded use of Web-based information changed. We believe that taking a month addresses of its owners, those with a and resources has fundamentally would represent a new facility or a controlling interest in the CAH or in any changed patient care, medical practice, facility that is experiencing major subcontractor in which the CAH and education. It has enabled providers restructuring. After a careful review of directly or indirectly has a 5 percent or to easily adjust policies and procedures the varied responses, we propose to more ownership interest, in accordance on an as-needed basis. We believe that provide flexibility and reduce burden by with 42 CFR part 420, subpart C. a prescriptive requirement to review revising the requirement at Section 42 CFR part 420, subpart C, sets policies and procedures annually could § 485.635(a)(4) to, at a minimum, only forth requirements for providers, Part B be eliminated to allow providers to require a biennial review of policies and suppliers, intermediaries, and carriers to review biennially and update as procedures. The 2-year review would disclose ownership and control necessary, or more frequently if needed. not preclude a facility from conducting information and sets forth requirements For example, we expect providers to a review more frequently if needed or for disclosure of information about a update their policies and procedures as organizing the review such that it would provider’s or Part B supplier’s owners needed in response to regulatory be completed over a 2-year period. and those with a controlling interest. changes, changes in the standard of Based on our experience with other The disclosure of ownership care, or nationally recognized providers, we believe that this approach provisions at 42 CFR part 420, subpart guidelines. would allow CAHs to maintain their C, are also required under the provider The current CoP at § 485.635(a)(4) health and safety policies in such a agreement rules under 42 CFR part 489. requires a CAH to review its policies at manner as to achieve the intended The term ‘‘provider agreement’’ is least annually by the CAH’s professional outcomes for all patients. Thus, we defined in § 489.3 as an agreement healthcare staff, including one or more propose to change the requirement at between CMS and a provider or supplier doctors of medicine or osteopathy and § 485.635(a)(4) from ‘‘annual’’ to to provide services to Medicare one or more physician assistants, nurse ‘‘biennial’’. beneficiaries and to comply with the practitioners, or clinical nurse Contact: Mary Collins, 410–786–3189.

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3. Special Requirements for CAH Consistent with our ‘‘Patients Over a week for several hours a day. The PHP Providers of Long-Term Care Services Paperwork’’ Initiative’’ we are client will have changing needs as they (‘‘Swing-Beds’’) (§ 485.645(d)(1), (4), (5) particularly interested in any progress through their treatment plan; and (8)) suggestions to improve existing therefore, updating the assessment every The special requirements for CAH requirements, within our statutory 30 days or sooner if the client’s swing-bed providers are nearly identical authority, where they make providing condition changes continues to be an to the requirements for hospital quality care difficult or less effective. important requirement for the PHP providers of swing-bed services. As a We also note that such suggestions client. could include or expand upon While the minimum 30 day update result, please refer to the discussion on comments submitted in response to the time fame at § 485.914(d) is needed for the special requirements for hospital FY 2018 Hospital Inpatient Prospective clients receiving PHP services, we do providers of swing-bed services under Payment System for Acute Care not believe that this time frame section II.D.3 for the details of the Hospitals and the Long-Term Care requirement supports the needs of all proposed changes for these Hospital Prospective Payment System CMHC clients. Clients that do not requirements. We propose the following RFI, found at https:// receive PHP services may be seen revisions to the CAH swing-bed www.regulations.gov/docket?D=CMS- weekly or every 2 weeks, while others requirements: 2017-0055. Public comments on the RFI are only seen every 2–6 months for a • Revision of § 485.645(d)(1) to can be found by searching for the terms medication follow up. Requiring an remove the cross-referenced long-term ‘‘RFI’’ or ‘‘request for information’’ in updated assessment every 30 days may care requirement in § 483.10(f)(9), the aforementioned 2017 payment not be practical for the non-PHP client, which requires that CAH swing-bed regulation docket on causing either additional visits or phone providers to offer residents the right to www.regulations.gov. calls from the CMHC to the client to choose to or refuse to perform services The most useful comments will be document ‘‘no changes in the client’s for the facility and prohibits a facility those that include data or evidence to assessment’’. This is not an efficient use from requiring a resident to perform support the position, offer suggestions of CMHC clinician or client time. services for the facility; • to amend specific sections of the Therefore, we propose to modify this Removal of § 485.645(d)(4), which existing regulations, or offer particular standard at § 485.914(d)(1) to require requires CAH swing-bed providers to additions. that the CMHC update each client’s provide an ongoing activity program comprehensive assessment via the I. Community Mental Health Center that is directed by a qualified CMHC interdisciplinary treatment team, (§ 485.914(d)) therapeutic recreation specialist or an in consultation with the client’s primary activities professional who meets On October 29, 2013, we published a health care provider (if any), when certain requirements (cross-referenced final rule (78 FR 209) that established, changes in the client’s status, responses long-term care requirement § 483.24(c)); for the first time, a set of requirements to treatment, or goal achievement have • Redesignation of paragraphs (d)(5) that Medicare-certified CMHCs must occurred, and in accordance with through (9) as (d)(4) through (8), meet in order to participate in the current standards of practice. respectively; Medicare program. These CoPs ensure Additionally at § 485.914(d)(3), we • Revision of § 485.645(d)(4) (as the quality and safety of CMHC care for propose to retain the minimum 30 day redesignated) to remove the cross- all clients served by the CMHC, assessment update time frame for those referenced long-term care requirement regardless of payment source. These clients who receive PHP services. We § 483.70(p), which requires that CAH requirements focus on a person- believe this proposed change will allow swing-bed providers with more than 120 centered, outcome-oriented process that for the provider and client to choose a beds to employ a qualified social worker promotes quality client care. These CoPs visit schedule that is appropriate for the on a full-time basis; and are set forth at 42 CFR part 485 and client’s condition and not cause extra • Revision of § 485.645(d)(7) (as apply to all Medicare participating work or time for documentation that is redesignated) to remove the cross- CMHCs. unnecessary. Ultimately, this proposed referenced long-term care requirement Medicare certified CMHCs provide change may allow for greater flexibility § 483.55(a)(1), which requires CAH services to a wide range of clients, from for the provider and client, saving time swing-bed providers to assist in those needing partial hospitalization for both. obtaining routine and 24-hour program (PHP) services to clients We seek to reduce burdens for health emergency dental care to its residents. needing routine counseling. Partial care providers and patients, improve the Contact: Kianna Banks, 410–786– hospitalization services are an intense quality of care, decrease costs, and 3498. level of services needed ‘‘to improve or ensure that patients and their providers We seek to reduce burdens for health maintain the individual’s condition and and physicians are making the best care providers and patients, improve the functional level and to prevent relapse health care choices possible. Therefore, quality of care, decrease costs, and or hospitalization. . . .’’ (section we are soliciting public comments on ensure that patients and their providers 1861(ff)(2) of the Act). As written, the additional regulatory reforms for burden and physicians are making the best current standard at § 485.914(d) requires reduction in future rulemaking. health care choices possible. Therefore, the CMHC to update the client Specifically, we are seeking public we are soliciting public comments on comprehensive assessment every 30 comment on additional proposals or additional regulatory reforms for burden days regardless of the client’s needs or modifications to the proposals set forth reduction in future rulemaking. treatment schedule. This 30 day update in this rule that would further reduce Specifically, we are seeking public of the comprehensive assessment burden on CMHCs and create cost comment on additional proposals or correlates with the CMS PHP payment savings, while also preserving quality of modifications to the proposals set forth regulations, requiring PHP clients to care and patient health and safety. in this rule that would further reduce receive an updated active treatment Consistent with our ‘‘Patients Over burden on CAHs and create cost plan every 30 days. Clients receiving Paperwork Initiative,’’ we are savings, while also preserving quality of PHP are more acute and typically particularly interested in any care and patient health and safety. receive care in the CMHC multiple days suggestions to improve existing

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requirements, within our statutory § 486.106, Condition for coverage: § 482.26(c)(2), which refers to authority, where they make providing Referral for service and preservation of qualifications of radiologic technologists quality care difficult or less effective. records. in hospitals, and is focused on the We also note that such suggestions At § 486.104, Condition for coverage: qualifications of the individual could include or expand upon Qualifications, orientation and health of performing services as permitted by comments submitted in response to the technical personnel, the portable x-ray State law. This change would not RFI that was included in the CY 2018 technologist must meet any one of four preclude state licensure entities and OPPS/ASC proposed rule. Public training and education requirements in portable x-ray suppliers from comments in response to this RFI can be § 486.104(a)(1), (2), (3), or (4). The establishing personnel requirements found at the following link: https:// requirement focuses on the that are more stringent that the www.regulations.gov/docket?D=CMS- accreditation of the school rather than proposed Federal requirements. 2017-0091. Public comments on the RFI the competency of the individual. In Second, paragraphs (a)(2), (3), and (4) can be found by searching for the terms contrast, § 482.26(c)(2), referring to establish different personnel ‘‘RFI’’ or ‘‘request for information’’ in qualifications of radiologic technologists qualifications based on the date that a the aforementioned 2017 payment in hospitals, is focused on the technologist received his or her regulation docket on qualifications of the individual education and training. We do not www.regulations.gov. performing services as permitted by believe that it is efficient or necessary to The most useful comments will be State law. Additionally, § 410.33(c), have varying qualifications based those that include data or evidence to which sets forth the personnel simply on the date that such training support the position, offer suggestions requirements for non-physician was received. We propose to replace to amend specific sections of the personnel used by an independent these four different qualifications with a existing regulations, or offer particular testing facility to perform tests, requires single, streamlined qualification that additions. that testing personnel, including x-ray focuses on the skills and abilities of the Contact: CAPT Mary Rossi-Coajou, technologists, must demonstrate the technologist. We believe that removing USPHS, 410–786–6051. basic qualifications to perform the tests school accreditation requirements and J. Portable X-Ray Services (§§ 486.104(a) in question and have training and simplifying the requirements will and 486.106(a)) proficiency as evidenced by licensure or reduce regulatory burden, streamline certification by the appropriate State the hiring process, and widen the pool Portable x-rays are basic radiology health or education department. These of individuals who may be employed by studies (predominately chest and two other regulatory requirements that portable x-ray suppliers to perform extremity x-rays) performed on patients govern the same type of technologists do portable x-ray services, particularly in skilled nursing facilities, residents of not have any accreditation those individuals who received training long term care facilities and homebound requirements. Based on our survey through the military for performing patients. Under the authority of section findings in hospitals, which have not portable x-rays, as military training 1861(s)(3) of the Act, the Secretary has identified widespread patient safety or programs are not accredited. established the CfCs that the supplier of quality of care concerns related to the Section 486.106(a)(2) contains portable x-ray services must meet to training and education levels of specific requirements for the content of participate in Medicare and Medicaid, technologists, we do not believe that the order for portable x-ray services, and and these conditions are set forth at removing the school accreditation requires that physician or non-physician §§ 486.100 through 486.110. The requirement from the portable x-ray practitioners orders for portable x-ray portable x-ray CfCs set forth at § 486.104 personnel requirements would services must be written and signed. were originally published on January negatively impact portable x-ray patient The requirements at § 486.106(a)(2) are 10, 1969 (34 FR 388) and were health and safety. inconsistent with the order redesignated on September 30, 1977 (42 We propose to remove the four requirements at § 410.32, which also FR 528260), and amended on April 12, training and education requirements for apply to portable x-ray suppliers, in two 1988 (53 FR 12015), August 30, 1995 (60 two reasons. First, paragraph (a)(1), and ways. First, the requirements at FR 45086), and November 19, 2008 (73 to some extent paragraph (a)(4), focus on § 486.106(a)(2) have different order FR 69942). The portable x-ray CfCs set the accreditation of the school where content requirements. Second, the forth at § 486.106 were originally the technologist received training, requirements at § 486.106(a)(2) have the published on January 10, 1969 (34 FR instead of focusing on the qualifications effect of limiting or precluding 388) and were redesignated on of the technologist performing the telephonic and electronic orders, which September 30, 1977 (42 FR 52826) and diagnostic test. Radiologic technicians are often more efficient ordering further redesignated and amended who practice in a hospital, and for methods. Section 410.32 allows for the January 9, 1995 (60 FR 2326), August whom there are no requirements to diagnostic service to be ordered in 30, 1995 (60 FR 45086), and November receive education and training by an writing, by telephone, or by secure 16, 2012 (77 FR 69372). The November accredited program, are legally allowed electronic methods. Although, § 410.32 2012 revision to the portable x-ray to perform any diagnostic imaging does not prescribe the form of an order. requirements allowed nurse procedure, including computed The Medicare Benefit Policy Manual practitioners and non-physician topography scans, mammograms, (Pub. 100–02), chapter 15, section 80.6 providers acting within their scope of sonograms, and many other procedures provides additional guidance on practice to order portable x-ray studies. that are more complex and require more § 410.32, and states: The current regulations are inconsistent expertise than portable x-rays. In ‘‘An order may be delivered via the with other rules governing diagnostic contrast, portable x-ray radiologic following forms of communication: studies, as described later in this section technicians typically perform basic x- • A written document signed by the of this proposed rule. In order to rays of the limbs (hand, foot) and chest, treating physician/practitioner, which is improve consistency, we propose and are limited in their duties by State hand delivered, mailed, or faxed to the changes to both § 486.104, Condition for scope of practice rules. For this reason testing facility; NOTE: No signature is coverage: Qualifications, orientation and we are aligning the current requirements required on orders for clinical health of technical personnel and at § 486.104(a)(1), (2), (3), and (4) with diagnostic tests paid on the basis of the

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clinical laboratory fee schedule, the providing quality care difficult or less utilizes costly staff resources. We physician fee schedule, or for physician effective. We also note that such propose to revise the current pathology services; suggestions could include or expand requirement at § 491.11(a) by changing • A telephone call by the treating upon comments submitted in response the frequency of the RHC or FQHC physician/practitioner or his or her to the RFI that was included in the CY evaluation from annually to every other office to the testing facility; and 2018 Revisions to Payment Policies year. The revised requirement would • An electronic mail by the treating under the Physician Fee Schedule and then require a biennial evaluation of its physician/practitioner or his or her Other Revisions to Part B. Public total program. Changing the program office to the testing facility. comments in response to this RFI can be evaluation requirement from annually to If the order is communicated via found at the following link: https:// every other year would not preclude the telephone, both the treating physician/ www.regulations.gov/docket?D=CMS- RHC or FQHC from conducting an practitioner or his or her office, and the 2017-0092. Public comments on the RFI evaluation more frequently or testing facility must document the can be found by searching for the terms maintaining their current annual telephone call in their respective copies ‘‘RFI’’ or ‘‘request for information’’ in evaluation, if they believe it is necessary of the beneficiary’s medical records. the aforementioned 2017 payment or if it is required by facility policy. While a physician order is not required regulation docket on Furthermore, the proposed changes to be signed, the physician must clearly www.regulations.gov. would give the RHC or FQHC the document, in the medical record, his or The most useful comments will be flexibility to focus only on certain her intent that the test be performed. those that include data or evidence to program areas, if they choose to do so, We propose to update § 486.106 support the position, offer suggestions for the off year in-between required (specific to portable x-ray services) to to amend specific sections of the program evaluations. The proposed cross reference the requirements at existing regulations, or offer particular change would reduce the paperwork § 410.32. We propose to retain the additions. burden of the RHC or FQHC and allow requirement that the portable x-ray Contact: Sonia Swancy, 410–786– clinicians to focus more on patient care. order must include a statement on why 8445. We believe that an evaluation of the it is necessary to perform a portable x- RHC or FQHC’s total program every ray as opposed to performing the study K. Rural Health Clinics (RHCs) and other year is sufficient to ensure in a facility where x-rays are more Federally Qualified Health Centers consistent quality of care, and that the typically performed. This change would (FQHCs) change from annual to biennial would allow for portable x-ray services to be 1. Provision of Services (§ 491.9(b)(4)) not negatively affect patient health and ordered in writing, by telephone, or by safety. We welcome the public’s electronic methods. The change would Currently, § 491.9(b)(4) requires RHCs comments on these proposed changes. also streamline the ordering process by and FQHCs to have their patient care We seek to reduce burdens for health avoiding the need to write two separate policies reviewed at least annually by care providers and patients, improve the orders for the same study, one to meet the designated group of professional quality of care, decrease costs, and the Medicare payment requirements in personnel who advise the RHC or FQHC ensure that patients and their providers accordance with § 410.32 and its in developing these policies (described and physicians are making the best associated Manual guidance, and at § 491.9(b)(2)), and reviewed as health care choices possible. Therefore, another to meet the content necessary by the RHC or FQHC. We we are soliciting public comments on requirements of the regulation set forth propose to reduce the frequency of additional regulatory reforms for burden at § 486.106. We believe the proposed policy reviews. We believe the reduction in future rulemaking. change would allow for additional requirement to review patient care Specifically, we are seeking public ordering flexibility to streamline policies annually is burdensome and comment on additional proposals or ordering practices while maintaining diverts staff from providing patient care. modifications to the proposals set forth ordering and documentation We propose to require the patient care in this rule that would further reduce requirements consistent with all other policies be reviewed on a biennial basis burden on RHCs and FQHCs and create diagnostic testing. by the group of professional personnel. cost savings, while also preserving We seek to reduce burdens for health Changing the review requirement from quality of care and patient health and care providers and patients, improve the annually to every other year would not safety. Consistent with our ‘‘Patients quality of care, decrease costs, and preclude the RHC or FQHC from Over Paperwork’’ Initiative, we are ensure that patients and their providers maintaining their current annual particularly interested in any and physicians are making the best review, if they believe it is necessary or suggestions to improve existing health care choices possible. Therefore, if it is required by facility policy. We requirements, within our statutory we are soliciting public comments on believe that this approach would allow authority, where they make providing additional regulatory reforms for burden RHCs and FQHCs to maintain their quality care difficult or less effective. reduction in future rulemaking. health and safety policies in such a We also note that such suggestions Specifically, we are seeking public manner as to achieve the intended could include or expand upon comment on additional proposals or outcomes for all patients. Thus, we comments submitted in response to RFIs modifications to the proposals set forth propose to change the requirement at that were included in the 2017 in this rule that would further reduce § 491.9(b)(4) from ‘‘annual’’ to prospective payment regulations for burden on suppliers of portable x-ray ‘‘biennial’’. most provider types. We refer readers to services and create cost savings, while the public comments that were 2. Program Evaluation (§ 491.11(a)) also preserving quality of care and submitted in response to the RFI for the patient health and safety. Consistent The current requirement at § 491.11(a) following 2017 payment regulations: with our ‘‘Patients Over Paperwork requires that the RHC or FQHC carries • End-Stage Renal Disease Initiative,’’ we are particularly out, or arranges for, an annual Prospective Payment System and interested in any suggestions to improve evaluation of its total program. Some Payment for Renal Dialysis Services existing requirements, within our RHCs and FQHCs have reported to us Furnished to Individuals with Acute statutory authority, where they make that this requirement is burdensome and Kidney Injury, and End-Stage Renal

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Disease Quality Incentive Program which established national emergency review of the emergency program is found at https://www.regulations.gov/ preparedness requirements for Medicare necessary or beneficial to the facility. In docket?D=CMS-2017-0084. and Medicaid participating providers response to their comments, we are • CY 2018 Home Health Prospective and suppliers (referred to collectively as therefore proposing to change this Payment System Rate Update; Value- ‘‘facilities’’ in the subsequent section) to requirement to require facilities to Based Purchasing Model; and Quality plan adequately for both natural and review their program at least every 2 Reporting Requirements found at man-made disasters and coordinate with years. This will increase the facility’s https://www.regulations.gov/ Federal, State, tribal, regional, and local flexibility to review their programs as docket?D=CMS-2017-0100. emergency preparedness systems. In they determine best fits their needs. We • FY 2018 Hospice Wage Index and that final rule, we emphasized the need expect that facilities would routinely Payment Rate Update and Hospice for facilities to maintain access to revise and update their policies and Quality found at https:// healthcare services during emergencies, operational procedures to ensure that www.regulations.gov/ safeguard human resources, and they are operating based on best document?D=CMS-2017-0062-0001. maintain business continuity and practices. In addition, facilities should • FY 2018 Hospital Inpatient protect physical resources. A facility’s Prospective Payment System for Acute emergency preparedness program must update their emergency preparedness Care Hospitals and the Long-Term Care include the following elements: program more frequently than every 2 years as needed (for example, if staff Hospital Prospective Payment System • Risk assessment and emergency changes occur or lessons-learned are RFI, found at https:// planning www.regulations.gov/docket?D=CMS- • Policies and procedures acquired from a real-life event or 2017-0055. • exercise). • Communication plan CY 2018 Hospital Outpatient PPS • Training and testing As noted in the Emergency Policy Changes and Payment Rates and After the publication of that final rule, Preparedness final rule (81 FR 63860), Ambulatory Surgical Center Payment we continued to review and analyze the ‘‘. . . there are various infections and System Policy Changes and Payment final emergency preparedness diseases, such as the Ebola outbreak in Rates found at https:// requirements and pertinent stakeholder October, 2014, that required updates in www.regulations.gov/docket?D=CMS- feedback. Upon further review, we facility assessments, policies and 2017-0091. • FY 2018 Inpatient Rehabilitation believe that some emergency procedures and training of staff beyond Facility Prospective Payment System preparedness requirements could be the directly affected hospitals. The final found at https://www.regulations.gov/ modified or eliminated to reduce rule requires that if a facility document?D=CMS-2017-0059-0002. provider and supplier burden while experiences an emergency, an analysis • FY 2018 Inpatient Psychiatric continuing to maintain essential of the response and any revisions to the Facilities Prospective Payment System emergency preparedness requirements emergency plan will be made and gaps found at https://www.regulations.gov/ that preserve the health and safety of and areas for improvement should be document?D=CMS-2017-0105-0002. patients in the United States. The addressed in their plans to improve the • CY 2018 Revisions to Payment following proposals would simplify the response to similar challenges for any Policies under the Physician Fee emergency preparedness requirements, future emergencies.’’ eliminate duplicative requirements, Schedule and Other Revisions to Part B The Assistant Secretary for found at https://www.regulations.gov/ and/or reduce the frequency with which Preparedness and Response (ASPR) docket?D=CMS-2017-0092. providers and suppliers would need to • FY 2018 Prospective Payment perform certain required activities. We Technical Resources, Assistance Center, System and Consolidated Billing for note that the current emergency and Information Exchange (TRACIE) Skilled Nursing Facilities found at preparedness standards are similar located at: https://asprtracie.hhs.gov/, is https://www.regulations.gov/ amongst all provider and supplier types, an excellent resource for the various document?D=CMS-2017-0060-0002. with a few variations to account for CMS providers and suppliers as they Public comments on the RFIs can be differences in health care settings. For seek to implement the emergency found by searching for the terms ‘‘RFI’’ clarity in the discussion later in this preparedness requirements. TRACIE is or ‘‘request for information’’ in the section of this proposed rule, we often designed to provide resources and aforementioned 2017 payment refer to the hospital regulatory citation technical assistance to healthcare regulation dockets on and we include specific references to system preparedness stakeholders in www.regulations.gov. other provider or supplier types when building a resilient healthcare system. The most useful comments will be necessary. There are numerous products and those that include data or evidence to 1. Annual Review of Emergency resources located within the TRACIE support the position, offer suggestions Preparedness Program (§§ 403.748, website that target specific provider to amend specific sections of the 416.54, 418.113, 441.184, 460.84, types affected by the emergency existing regulations, or offer particular 482.15, 483.73, 483.475, 484.102, preparedness aspects of this proposed additions. 485.68, 485.625, 485.727, 485.920, rule. While TRACIE does not focus Contact: CAPT Jacqueline Leach, 486.360, 491.12, and 494.62 (a), (b), (c), specifically on the requirements USPHS, 410–786–4282. and (d)) implemented in this proposed L. Emergency Preparedness for Facilities are currently required to regulation, this is a valuable resource to Providers and Suppliers annually review their emergency aid a wide spectrum of partners with On September 16, 2016, we published preparedness program, which includes a their health system emergency a final rule entitled, ‘‘Medicare and review of their emergency plan, policies preparedness activities. We strongly Medicaid Programs; Emergency and procedures, communication plan, encourage providers and suppliers to Preparedness Requirements for and training and testing program. utilize TRACIE and leverage the Medicare and Medicaid Participating However, pertinent stakeholders information provided by ASPR. Providers and Suppliers’’ (81 FR 63860), continue to question whether an annual

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2. Documentation of Cooperation Efforts 3. Annual Emergency Preparedness natural or-man made emergency that (§§ 403.748(a)(4), 416.54(a)(4), Training Program (§§ 403.748(d)(1)(ii), requires activation of the emergency 418.113(a)(4), 441.184(a)(4), 416.54(d)(1)(ii), 418.113(d)(1)(ii), plan (including their communication 460.84(a)(4), 482.15(a)(4), 483.73(a)(4), 441.184(d)(1)(ii), 460.84(d)(1)(ii), plan) and revision of the plan as 483.475(a)(4), 484.102(a)(4), 482.15(d)(1)(ii), 483.73(d)(1)(ii), needed), the facility is exempt from 485.68(a)(4), 485.625(a)(4), 483.475(d)(1)(ii), 484.102(d)(1)(ii), engaging in a community-based or 485.920(a)(4), 486.360(a)(4), 485.68(d)(1)(ii), 485.625(d)(1)(ii), individual, facility based full-scale 491.12(a)(4), and 494.62(a)(4)) 485.727(d)(1)(ii), 485.920(d)(1)(ii), exercise for 1 year following the onset 486.360(d)(1)(ii), 491.12(d)(1)(ii), and of the actual event; Facilities are currently required to 494.62(d)(1)(ii) • Conduct an additional exercise that may include either a second full-scale develop and maintain an emergency Facilities are required to develop and exercise that is community-based or preparedness plan that includes a maintain a training program that is process for cooperation and individual, facility-based or a tabletop based on the facility’s emergency plan. exercise that includes a group collaboration with local, tribal, regional, This emergency preparedness training State, and Federal emergency discussion led by a facilitator. must be provided at least annually and Upon further analysis of this preparedness officials’ efforts to a well-organized effective training requirement, and taking into account maintain an integrated response during program must include initial training in stakeholder feedback, we have a disaster or emergency situation, emergency preparedness policies and determined that there is also a need to including documentation of the procedures. We revisited the public clarify and revise some of the facilities’ efforts to contact such officials comments received on the Emergency requirements included in the and, when applicable, of its Preparedness proposed rule (81 FR Emergency Preparedness final rule (81 participation in collaborative and 63890 through 63891) and determined FR 63860). We propose to clarify our cooperative planning efforts. Upon that requiring facilities to provide intent with regard to the types of testing further review of this requirement, we annual training may be unduly exercises, specifically full-scale believe that elements of this burdensome. We are therefore proposing exercises and functional exercises. As requirement are unduly burdensome on to change this requirement to require noted in the Emergency Preparedness facilities. Therefore, we propose to that facilities provide training biennially proposed rule (78 FR 79101), a full-scale eliminate the requirement that facilities or every 2 years, after facilities conduct exercise is a multi-agency, document efforts to contact local, tribal, initial training on their emergency multijurisdictional, multi-discipline regional, State, and Federal emergency program. In addition, we propose to exercise involving functional (for require additional training when the preparedness officials and facilities’ example, joint field office, emergency emergency plan is significantly updated. participation in collaborative and operation centers, etc.) and ‘‘boots on For example, when a facility makes the ground’’ responses (for example, cooperative planning efforts. Facilities substantial changes to the procedures or will still be required to include a firefighters decontaminating mock protocols within the emergency plan, victims). We expect facilities to engage process for cooperation and we would require additional training on in such comprehensive exercises with collaboration with local, tribal, regional, the updated emergency plan. Other non- coordination across the public health State and Federal emergency significant updates, such as revisions to system and local geographic area, if preparedness officials’ efforts to the communication plan regarding possible. Moreover, a functional maintain an integrated response during contact information for staff, could be exercise examines or validates the a disaster or emergency situation. We sent in company memorandum or coordination, command, and control believe that eliminating this provided to the facility’s staff through between various multiagency documentation requirement will reduce other means. These proposed changes coordination centers (for example, provider and supplier burden by not give facilities additional flexibility to emergency operation center, joint field requiring facilities to demonstrate that determine what is appropriate for their office, etc.). A functional exercise does they have contacted local, tribal, facility’s or staff’s needs while not involve any ‘‘boots on the ground’’ regional, State, and Federal emergency maintaining adequate readiness. (that is, first responders or emergency officials responding to an incident in preparedness officials or participated in 4. Annual Emergency Preparedness real time). The term ‘‘functional collaborative and cooperative planning Testing (§§ 403.748(d)(2), 416.54(d)(2), exercise’’ more accurately reflects our in the community, while still requiring 418.113(d)(2), 441.184(d)(2), intentions for the testing requirement in facilities to at least include a process for 460.84(d)(2), 482.15(d)(2), 483.73(d)(2), the Emergency Preparedness final rule cooperation and collaboration. We 483.475(d)(2), 484.102(d)(2), (81 FR 63860). We believe that there are continue to encourage facilities to 485.68(d)(2), 485.625(d)(2), participate, when available, in opportunities to reduce the burden for 485.727(d)(2), 485.920(d)(2), inpatient and outpatient providers to community cooperative and 486.360(d)(2), 491.12(d)(2), and meet the testing requirement. collaborative planning efforts and 494.62(d)(2)) For providers of inpatient services, we execute the training and testing Facilities are currently required to propose to expand the testing requirements in § 482.15 (d) for conduct exercises to test the emergency requirement options such that one of the hospitals and similar parallel citations plan at least annually. The facility must two annually required testing exercises for other facilities. conduct two emergency preparedness may be an exercise of their choice, testing exercises every year. which may include one community- Specifically, facilities must: based full-scale exercise (if available), • Participate in a full-scale exercise an individual facility-based functional that is community-based or when a exercise, a drill, or a tabletop exercise or community-based exercise is not workshop that includes a group accessible, an individual, facility-based. discussion led by a facilitator. As If the facility experiences an actual indicated in the Emergency

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Preparedness proposed rule, ‘‘A outpatient providers will be exempt www.regulations.gov/docket?D=CMS- workshop resembles a seminar, but is from their next required full-scale 2017-0055. employed to build specific products, community-based exercise or • CY 2018 Hospital Outpatient PPS such as a draft plan or policy (for individual, facility-based functional Policy Changes and Payment Rates and example, a Training and Exercise Plan exercise following the onset of the Ambulatory Surgical Center Payment Workshop is used to develop a actual event. A facility’s communication System Policy Changes and Payment Multiyear Training and Exercise Plan)’’ plan is part of their emergency plan, as Rates found at https:// (78 FR 79101). Providers of inpatient is coordination with other community www.regulations.gov/docket?D=CMS- services include RNHCIs, inpatient emergency preparedness officials (for 2017-0091. hospice facilities, Psychiatric example, emergency management and • FY 2018 Inpatient Rehabilitation Residential Treatment Facilities public health), and we expect that these Facility Prospective Payment System (PRTFs), hospitals, long-term care elements, along with the completion of found at https://www.regulations.gov/ facilities (LTCFs), ICFs/IIDs, and CAHs. a corrective action plan, are part of the document?D=CMS-2017-0059-0002. We believe this will allow greater activation of their emergency plan. • FY 2018 Inpatient Psychiatric flexibility for inpatient providers to We seek to reduce burdens for health Facilities Prospective Payment System meet this requirement. We note that care providers and patients, improve the found at https://www.regulations.gov/ although RNHCIs provide inpatient quality of care, decrease costs, and document?D=CMS-2017-0105-0002. • services, we have determined that ensure that patients and their providers CY 2018 Revisions to Payment changing their existing requirements to and physicians are making the best Policies under the Physician Fee make them consistent with this health care choices possible. Therefore, Schedule and Other Revisions to Part B proposed provision will be unduly we are soliciting public comments on found at https://www.regulations.gov/ burdensome as they are currently docket?D=CMS-2017-0092. additional regulatory reforms for burden • required to conduct a paper-based, reduction in future rulemaking. FY 2018 Prospective Payment tabletop exercise at least annually. Specifically, we are seeking public System and Consolidated Billing for For providers of outpatient services, comment on additional proposals or Skilled Nursing Facilities found at we believe that conducting two testing modifications to the proposals set forth https://www.regulations.gov/ exercises per year is overly burdensome in this rule that would further reduce document?D=CMS-2017-0060-0002. as these providers do not provide the burden on all Medicare and Medicaid Public comments on the RFIs can be same level of acuity or inpatient participating providers and suppliers found by searching for the terms ‘‘RFI’’ services for their patients. Therefore, we mentioned in this section and create or ‘‘request for information’’ in the propose to require that providers of cost savings, while also preserving aforementioned 2017 payment outpatient services conduct only one quality of care and patient health and regulation dockets on testing exercise per year. Furthermore, safety. Consistent with our ‘‘Patients www.regulations.gov. The most useful we propose to require that these Over Paperwork’’ Initiative, we are comments will be those that include providers participate in either a particularly interested in any data or evidence to support the position, community-based full-scale exercise (if suggestions to improve existing offer suggestions to amend specific available) or conduct an individual requirements, within our statutory sections of the existing regulations, or facility-based functional exercise every authority, where they make providing offer particular additions. other year. In the opposite years, we quality care difficult or less effective. Contact: Kianna Banks, 410–786– propose to allow these providers to We also note that such suggestions 3498. conduct the testing exercise of their could include or expand upon choice, which may include either a III. Collection of Information comments submitted in response to RFIs community-based full-scale exercise (if Requirements that were included in the following available), an individual, facility-based Under the Paperwork Reduction Act 2017 payment regulations: functional exercise, a drill, or a tabletop • of 1995 (PRA), we are required to exercise or workshop that includes a End-Stage Renal Disease provide 60-day notice in the Federal group discussion led by a facilitator. Prospective Payment System and Register and solicit public comment Providers of outpatient services include Payment for Renal Dialysis Services before a collection of information ASCs, freestanding/home-based Furnished to Individuals with Acute requirement is submitted to the Office of hospice, Program for the All-Inclusive Kidney Injury, and End-Stage Renal Management and Budget (OMB) for Care for the Elderly (PACE), HHAs, Disease Quality Incentive Program review and approval. In order to fairly CORFs, Organizations (which include found at https://www.regulations.gov/ evaluate whether an information Clinics, Rehabilitation Agencies, and docket?D=CMS-2017-0084. • collection should be approved by OMB, Public Health Agencies as Providers of CY 2018 Home Health Prospective section 3506(c)(2)(A) of the PRA Outpatient Physical Therapy and Payment System Rate Update; Value- requires that we solicit comment on the Speech-Language Pathology Services), Based Purchasing Model; and Quality following issues: CMHCs, Organ Procurement Reporting Requirements found at • The need for the information Organizations (OPOs), RHCs, FQHCs, https://www.regulations.gov/ collection and its usefulness in carrying and ESRD facilities. Due to the nature of docket?D=CMS-2017-0100. out the proper functions of our agency. services provided by OPOs we propose • FY 2018 Hospice Wage Index and • The accuracy of our estimate of the to require that they have the option of Payment Rate Update and Hospice information collection burden. providing either a tabletop exercise or Quality found at https:// • The quality, utility, and clarity of workshop every year. www.regulations.gov/ the information to be collected. Lastly, we propose to clarify the document?D=CMS-2017-0062-000. • Recommendations to minimize the testing requirement exemption by • FY 2018 Hospital Inpatient information collection burden on the noting that if a provider experiences an Prospective Payment System for Acute affected public, including automated actual natural or man-made emergency Care Hospitals and the Long-Term Care collection techniques. that requires activation of their Hospital Prospective Payment System We are soliciting public comment on emergency plan, inpatient and RFI, found at https:// each of the section 3506(c)(2)(A)-

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required issues for the following A. Wages oes/2016/may/oes_nat.htm). In this information collection requirements To derive average costs, we used data regard, the following table presents the (ICRs). from the U.S. Bureau of Labor Statistics’ mean hourly wage, the cost of fringe May 2016 National Occupational benefits and overhead costs (calculated Employment and Wage Estimates for all at 100 percent of salary), and the salary estimates (https://www.bls.gov/ adjusted hourly wage.

NATIONAL OCCUPATIONAL EMPLOYMENT AND WAGE ESTIMATES

Mean hourly Fringe Adjusted Occupation title Occupation wage benefit hourly wage code ($/hour) ($/hour) ($/hour)

Healthcare Support Worker ...... 31–9099 $18.13 $18.13 $36 Physicians and Surgeons ...... 29–1060 101.04 101.04 202 Physicians and Surgeons, All Other ...... 29–1069 98.83 98.83 198 Physicians, Psychiatrists ...... 29–1066 94.26 94.26 189 Surgeons ...... 29–1067 121.59 121.59 243 Registered Nurse (RN—Quality Improvement, Home Care Coordinator, HealthCare Trainer, Quality Assurance Nurse, QAPI Nurse Coordinator, Infection Control Nurse Coordinator, Psychiatric RN) ...... 29–1141 34.70 34.70 69 Medical Secretary (Clerical, Administrative Assistant) ...... 43–6013 16.85 16.85 34 Administrative Services Manager (Facility Director) ...... 11–3011 47.56 47.56 96 Management Occupations (Director, Community Relations Manager, Admin- istrator) ...... 11–0000 56.74 56.74 114 Pharmacist ...... 29–1051 57.82 57.82 115 Medical and Health Services Manager (Administrator, Transplant Program Senior Administrator/Hospital Administrator/Medical and Health Services Managers, Program Director, Risk Management Director. QAPI Director, Organ Procurement Coordinator, Nurse manager, Director of Nursing, Nursing care facilities/skilled nursing facilities) ...... 11–9111 52.58 52.58 105 Managers, All Others(Administrator) ...... 11–9199 53.92 53.92 108 * Activities Specialist (Recreational Therapists, Nursing Care Facilities/ SNFs) ...... 29–1125 19.92 19.92 40 Internists (Medical Director, General Physician ...... 29–1063 97.04 97.04 194 Family and General Practitioner (Medical Director) ...... 29–1062 96.54 96.54 194 Physical Therapist (Director of Rehab) ...... 29–1123 41.93 41.93 84 Healthcare Social Worker (Social Worker) ...... 21–1022 26.69 26.69 53 Mental Health and Substance Abuse Social Worker (Social Worker) ...... 21–1023 23.02 23.02 46 Nurse Practitioner (Clinician, Nurse Practitioner Outpatient Care Center) ..... 29–1171 50.30 50.30 101 Mental Health Counselor ...... 21–1014 22.14 22.14 44 Physician Assistant ...... 29–1071 49.08 49.08 98 Licensed Practical and Licensed Vocational Nurses (Director of Nursing) .... 29–2061 21.56 21.56 44 First Line Supervisors of Office and Administrative Support Workers (Office Manager) ...... 43–1011 27.83 27.83 56 Office Clerks, General (Clerical staff) ...... 43–9061 15.87 15.87 32 Secretaries and Administrative Assistants (Clerical staff) ...... 43–6010 19.39 19.39 38 Chief Executive ...... 11–1011 93.44 93.44 186 * Salary information used is for Nursing Care Facility/SNF industry. As indicated, we are adjusting our employee hourly wage estimates by a factor of 100 percent. This is necessarily a rough adjustment, both because fringe benefits and overhead costs vary significantly from employer to employer, and because methods of estimating these costs vary widely from study to study. Nonetheless, there is no practical alternative and we believe that doubling the hourly wage to estimate total cost is a reasonably accurate estimation method.

B. ICRs Regarding RNHCI Discharge data, there was a combined annual total serve. We estimate that the healthcare Planning (§ 403.736(a) and (b)) of 619 beneficiaries that stayed in the 18 support worker responsible for a facilities. patients discharge plan is paid at mean Section 403.736 will reduce the wage of $36, including 100 percent for extensive requirements for an RNHCI to We estimate that the time currently coordinate with other medical providers required to develop and document fringe and overhead costs. Based on our for post-RNHCI care. The discharge discharge plans and activities is 1,238 experience with RNHCIs, we estimate evaluation must include an assessment burden hours (2 hours for each of the that it would take 1 hour to develop the of a patient’s capacity for self-care and 619 beneficiaries discharged) and that it proposed discharge instructions and information regarding the care once the would be reduced by half. Of the discuss them with the patient and/or patient leaves the facility. The nursing approximately 619 annual discharges, caregiver. We estimate a total of 619 staff would need to prepare the patient we estimate that a RNHCIs burden annual discharges from RNHCIs at a and/or their caregiver for discharge. would be reduced to one hour for each savings of $36 per discharge for a total Most patients are discharged to home or discharged individual. A RNHCI would savings of $22,284 ($36 × 619 hours). to another facility that adheres to the not need to develop a discharge plan same religious tenets. Although all that includes medical care once a patients must have a discharge planning patient leaves the RNHCI because doing evaluation, not all patients require a so would not be in keeping with the discharge plan. Based on recent claims religious tenets of the patients they

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C. ICRs Regarding ASC Governing Body form of history and physical that would State law, who is an employee of or and Management (§ 416.41(b)(3)(i) and require pre-operative examination and under contract with the hospice to (ii)) testing, and on what time schedule. The ensure that drugs and biologicals meet We propose to eliminate the current information collection request each patient’s needs. The information requirements at § 416.41(b)(3) that states for the ASC rules (OMB control number collection request for the hospice 0938–1071) does not account for any the ASC must have a written transfer requirements (OMB control number information collection related burden agreement with a hospital or ensure all 0938–1067, currently under review at associated with the comprehensive H&P physicians performing surgery in the OMB) states that the burden associated requirement. We assume that creating ASC have admitting privileges at a local with this requirement is the time these policies (which could leave such hospital that meets CMS hospitalization necessary to document the results of decisions to the surgeon’s discretion in requirements. All ASCs easily meet this this consultation in each patient’s most or all cases) would require 10 requirement and have established a clinical record. In the information hours of physician time, 10 hours of RN relationship with their local hospital collection request we assumed that an time, and 10 hours of clerical time, at and obtained an agreement as usual and average hospice would confer with a the preceding hourly rates, for a total of customary practice for running an ASC pharmacist, and that the pharmacist 30 hours per facility. This would be a would document the results of his/her with the exception of approximately one-time cost of $3,440 per facility ([10 twenty ASCs that have difficult consultation. We estimated that it × $243] + [10 × $69] + [10 × $32]), and requires 5 minutes to document the relationships with their local hospitals. $19.1 million for all 5,557 facilities. The savings would not be significant, initial review of a patient’s drug and Therefore, this proposed requirement biologicals. Additionally, we estimated however, it does affect the 20 ASCs by would increase the information removing the requirement. The current that it requires 5 minutes of the collection related burden by $19.1 pharmacist’s time to document a review information collection request for the million and 166,710 hours (30 hours × ASC rules (OMB control number 0938– of updates to the patient’s drug profile. 5,557 facilities) on a one-time basis for Based on a 17 day median length of 1071) does not address any potential all ASCs. The information collection burden associated with this service, we assumed that each patient request will be revised to account for would likely receive one update to their requirement. We believe that having and the additional burden. maintaining written agreements is plans of care. At an average hourly rate standard practice. Therefore, removing F. ICRs Regarding Hospice Aide and of $115 for a pharmacist, we estimated this requirement would not alter the Homemaker Services (§ 418.76) that it would cost a hospice $19 per patient ($115 × [5 minutes for initial + current information collection burden At § 418.76(a) we propose to defer to 5 minutes for 1 update]) and an annual for ASCs. State training and competency cost of $6,764 ($19 × 356 patients). The requirements, where they exist, for D. ICR Regarding ASC Medical Records total annual burden hours for all hospice aides. The information (§ 416.47(b)(2)) hospices was estimated to be 264,588 collection request for the hospice hours (1,587,527 patients × .1666 hour We propose to revise § 416.47(b)(2) by requirements (OMB control number per patient), and the total annual burden adding the phrase ‘‘(as applicable)’’ to 0938–1067) is currently under review at cost for all hospices was estimated to be the significant medical history and OMB. It estimates that a hospice would $30,163,013 ($19 per patient × 1,587,527 results of physical examination spend 5 minutes per newly hired requirement of documents that must be hospice aide to document verification patients). Therefore, removing the included in the medical record in order that an aide meets the required training requirement that a hospice must ensure to conform to the changes that we are and competency requirements, for a that the interdisciplinary group confers proposing to the mandatory medical total of 372 annual burden hours for all with an individual with education and history and physical examination hospices at a cost of $11,540. This training in drug management would requirement. There are no collection of proposed change to the actual training result in a burden reduction of 264,588 information requirements associated and competency requirements would hours and $30,163,013. with this proposed change because not alter the requirement to document We assume that, upon maintaining a medical record for each the fact that a hospice aide meets one of implementation of the proposed change patient is a usual and customary the training and competency to allow hospices to provide practice in accordance with the requirements set forth in the rule; information regarding the safe implementing regulations of the PRA at therefore there would be no change to maintenance and disposal of controlled 5 CFR 1320.3(b)(2). the existing collection of information drugs in a more user-friendly manner, hospices would develop understandable E. ICRs Regarding ASC Patient estimates because the estimates relate to the unchanged documentation instructions in layperson terms to Admission, Assessment and Discharge replace the copy of the policies and (§ 416.52(a)(1), (2), (3) and (4)) requirements rather than the actual training and competency requirements procedures that is currently provided. At § 416.52 we propose to replace the that would be revised by this proposed While the instructions could be created requirement that every patient have a change. in any number of formats, such as a comprehensive medical history and slide show, video, podcast, or physical examination (H&P) within 30 G. ICRs Regarding Drugs and pictograph, for purposes of our analysis days prior to surgery in an ASC with a Biologicals, Medical Supplies, and we assume that hospices would create requirement that allows the operating Durable Medical Equipment written instructions. We estimate that a physician and ASC to determine which (§ 418.106(a) and (e)(2)(i)) hospice would use 1 hour of patients would require more extensive At § 418.106(a) we propose to remove administrator time to develop a new testing and assessment prior to surgery. the requirement that a hospice ensure form at $105 per hour. For all 4,602 The burden associated with this that the interdisciplinary group confers hospices, the total initial cost would be requirement would be the time and with an individual with education and $483,210. effort necessary to create new policies training in drug management as defined The information collection request for when, and whether, to require some in hospice policies and procedures and will be revised and sent to OMB.

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H. ICRs Regarding Hospices That local laws. The system governing body prior to surgery in an ASC with a Provide Hospice Care to Residents of a would be responsible and accountable requirement that allows the operating SNF/NF or ICF/IID (§ 418.112(c)(10) and for ensuring that each of its separately physician and ASC to determine which (f)) certified hospitals meets all of the patients would require more extensive At § 418.112(f) we propose to allow requirements of this section. Each testing and assessment prior to surgery. hospices and long term care facilities separately certified hospital subject to As discussed in ‘‘Provisions of the the additional flexibility to negotiate the the system governing body would have Proposed Regulations,’’ section II.D.2 of format and schedule for orienting long to demonstrate that: the unified and this proposed rule, there is a similar term care facility staff regarding certain integrated QAPI program was regulatory requirement for hospital hospice-specific information. A hospice established in a manner that took into outpatient surgery. Based on the account each member hospital’s unique substantial similarity between these two and SNF/NF or ICF/IID must have a circumstances and any significant service settings, we propose, through written agreement that specifies the differences in patient populations and the revisions to §§ 482.22, 482.24, and provision of hospice services in the services offered in each hospital; and 482.51 discussed in section II.D.2, to facility. The agreement must be signed the unified and integrated QAPI provide an exception to these by authorized representatives of the program establishes and implements requirements for outpatient surgery in hospices and the SNF/NF or ICF/IID policies and procedures to ensure that hospitals. prior to the provision of hospice care the needs and concerns of each of its As stated in the information services. The burden associated with separately certified hospitals, regardless collection request for the hospital this requirement is the time and effort of practice or location, are given due requirements (OMB control number necessary to develop, draft, sign, and consideration, and that the unified and 0938–0328), which is in the process of maintain the written agreement. As integrated QAPI program has being reinstated, we estimate that the stated in the hospice information mechanisms in place to ensure that burden associated with updating and, in collection request (OMB control number issues localized to particular hospitals some instances, writing new hospital 0938–1067, currently under review at are duly considered and addressed. policies directly related to patient care OMB), the use of this type of written As stated in the information would be an average of eight (8) hours agreement is a usual and customary collection request for the hospital annually for each member of hospital business practice and the associated requirements (OMB control number staff involved in the specific patient burden is exempt from the PRA under 0938–0328), which is in the process of care policies addressed. the implementing regulations at 5 CFR being reinstated, we estimate that the Patient care policy development (and 1320.3(b)(2). However, updating the burden associated with updating and, in revision) by hospital medical staff is written agreement to address this new some instances, writing new hospital essential to patient health and safety requirement would not constitute a policies directly related to patient care because it provides the framework usual and customary business practice; would be an average of eight (8) hours within which all patient care services therefore, we believe that a one-time annually for each member of hospital are furnished. Thus, we have included burden to update the written agreement staff involved in the specific patient the involvement of a physician at would be imposed by this change. For care policies addressed. approximately $1,584 annually (8 purposes of this analysis only, we Patient care policy development (and burden hours × $198), a nurse estimate that each hospice would use 8 revision) by hospital medical staff is coordinator at $552 annually (8 burden hours of administrator time to revise the essential to patient health and safety hours × $69), and a medical secretary at existing written agreement. At a cost of because it provides the framework $272 annually (8 burden hours × $34). $105 per hour for an administrator to within which all patient care services We estimate that the necessary policy complete this task, we estimate that the are furnished. Thus, we have included changes needed to comply with the onetime cost per hospice would be the involvement of a physician at requirements proposed in this rule $840. For all hospices the onetime cost approximately $1,584 annually (8 would cost $2,408 per year ($1,584 + would be $3,865,680 (4,602 hospices × burden hours × $198), a QAPI nurse $552 + $272) for each of the 5,031 $840) for 36,816 hours (4,602 hospices coordinator at $552 annually (8 burden hospitals that might choose to exercise × 8 hours). The information collection hours × $69), and a medical secretary at this option. Therefore, the total annual request will be revised to account for $272 annually (8 burden hours × $34). cost for all hospitals to meet these this one time increase in burden and We estimate the necessary policy information collection requirements sent to OMB. changes needed to comply with the would be approximately $12.1 million. requirements proposed in this rule I. ICRs Regarding Hospital Quality K. ICRs Regarding Hospital Medical would cost $2,408 per year ($1,584 + Assessment and Performance Staff: Autopsies (§ 482.22)(d)) $552 + $272) for each of the 424 Improvement (QAPI) Program (§ 482.21) hospital systems that would be eligible We propose to remove the We propose a new standard at to do so and that would choose to requirement at § 482.22(d), which § 482.21(f), ‘‘Unified and integrated exercise this option. Therefore, the total recommends that a hospital’s medical QAPI program for multi-hospital annual cost for all eligible hospital staff attempt to secure autopsies in all systems’’. We would allow that for a systems to meet these information cases of unusual deaths and of medical- hospital that is part of a hospital system collection requirements would be legal and educational interest. Hospitals consisting of two or more separately approximately $1 million. are further required to define a certified hospitals subject to a system mechanism for documenting permission governing body legally responsible for J. ICRs Regarding Hospital Medical to perform an autopsy, and they must the conduct of each hospital, the system Staff, Medical Records Services, and have a system for notifying the medical governing body could elect to have a Surgical Services (§§ 482.22, 482.24, staff, and specifically the attending unified and integrated QAPI program for and 482.51) practitioner, when an autopsy is being all of its member hospitals after At § 416.52 we propose to replace the performed. Since more detailed, specific determining that such a decision is in requirement that every patient have a requirements regarding medical-legal accordance with all applicable State and comprehensive H&P within 30 days investigations and autopsies for

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hospitals are covered by the individual staff involved in the specific patient this requirement is approximately $29 State laws in which the hospital is care policies addressed. million for all hospital and CAH swing- located, there are no collection of Patient care policy development (and bed providers, or $16,821 per hospital information requirements associated revision) by hospital medical staff is or CAH swing-bed provider (1,724 with this proposed change. essential to patient health and safety hospital and CAH swing-bed providers because it provides the framework × $40 an hour for an activities specialist L. ICRs Regarding Hospital Infection within which all patient care services × 8 hours per week × 52 weeks per year), Control (§ 482.42) are furnished. Thus, we have included which are the cost savings to the We propose a new standard at the involvement of a physician at providers as a result of the removal of § 482.42(c), ‘‘Unified and integrated approximately $1,584 annually (8 this requirement. infection control program for multi- burden hours × $198), an infection At § 482.58(b)(4) (and § 485.645(d)(4)) hospital systems.’’ Like the proposed control nurse coordinator at $552 (cross-referenced long-term care requirements for a unified and annually (8 burden hours × $69), and a requirement at § 483.24(c)), we propose integrated QAPI program, the proposed medical secretary at $272 annually (8 to remove the requirement for hospital standard for infection control would burden hours × $34). and CAH swing-bed providers to allow that for a hospital that is part of We estimate the necessary policy provide an ongoing activity program a hospital system consisting of multiple changes needed to comply with the that is directed by a qualified separately certified hospitals subject to requirements proposed in this rule therapeutic recreation specialist or an a system governing body legally would cost $2,408 per year ($1,584 + activities professional who meets responsible for the conduct of each $552 + $288) for each of the 424 certain requirements as listed at hospital, such system governing body hospital systems that would be eligible § 483.24(c)(2). We assume that each of could elect to have a unified and to do so and that would elect to exercise the hospital swing-bed providers (478 integrated infection control program for this option. Therefore, the total annual hospitals) and CAH swing-bed providers all of its member hospitals after cost for all eligible hospital systems to (1,246 CAHs) has an activities specialist determining that such a decision was in meet these information collection employed at least part time at $40 per accordance with all applicable State and requirements would be approximately hour. CAHs are required to provide local laws. The system governing body $1 million. activity services by either a qualified would be responsible and accountable M. ICRs Regarding Special individual who meet the requirements for ensuring that each of its separately Requirements for Hospital Providers of of § 483.24(c)(2), or by an individual on certified hospitals met all of the Long-Term Care Services (‘‘Swing- the facility staff who is designated as the requirements of this section. Each Beds’’) (§ 482.58(b)(1), (4), (5), and (8), activities director and who serves in separately certified hospital subject to and Identical CAH requirements: consultation with a therapeutic the system governing body would have § 485.645(d)(1), (4), (5), and (8)) recreation specialist, occupational to demonstrate that the unified and therapist, or other professional with integrated infection control program: (1) At §§ 482.58(b)(1) and 485.645(d)(1) experience or education in recreational Was established in a manner that took (cross-referenced long-term care therapy. For the purpose of this into account each member hospital’s requirement at § 483.10(f)(9)) we analysis, we assume that the cost of unique circumstances and any propose to remove the requirement for each would be the same due to the rural significant differences in patient hospital and CAH swing-bed providers location of CAHs. The current populations and services offered in each to provide the right for patients to regulatory burden for compliance with hospital; (2) established and choose to or refuse to perform services this requirement is based on the implemented policies and procedures to for the facility and if they so choose; (a) activities specialist organizing, ensure that the needs and concerns of document in the resident’s plan of care, overseeing, and scheduling the activity. each of its separately certified hospitals, (b) noting whether the services are The cost savings as a result of the regardless of practice or location, were voluntary or paid and (c) provide wages removal of this requirement are given due consideration; (3) had for the work being performed given the approximately $72 million for all mechanisms in place to ensure that location quality, and quantity of work hospital and CAH swing-bed providers, issues localized to particular hospitals requiring comparable skills. We believe or $41,800 per hospital or CAH swing- were duly considered and addressed; this requirement is unduly burdensome bed provider (1,724 hospital and CAH and (4) has designated a qualified as we do not expect patient’s receiving swing-bed providers × $40 an hour for individual(s) with expertise in infection hospital or CAH swing-bed services an activities specialist × 1,040 hours per prevention and control at the hospital to have an average length of stay long year) which are the cost savings to the be responsible for communicating with enough to be positively impacted by providers. Our analysis assumes that the the unified infection control program, providing services to the facility. We reduced staffing is largely for part-time for implementing and maintaining the assume that each of the hospital swing- work assignment (1,040 hours annually) policies and procedures governing bed providers (478 hospitals) and CAH at hospital and CAH swing-bed infection control, and for providing swing-bed providers (1,246 CAHs) has providers. It is likely that many of the infection prevention education and an activities specialist employed at $40 actual persons holding these positions training to hospital staff. per hour who would oversee the were full-time workers not devoted As stated in the information residents who have chosen to perform solely to recreational therapy, whose collection request for the hospital services for the facility, and document hours will simply be reassigned to other requirements (OMB control number and update the plan of care accordingly. functions, with providers ultimately 0938–0328), which is in the process of We believe that given the limited budget saving these full-time equivalent hours being reinstated, we estimate that the of most rural providers, services are through ripple effects on an even wider burden associated with updating and, in being provided to the CAH on a range of staffing functions through some instances, writing new hospital voluntary basis and that these providers turnover over time. policies directly related to patient care are not compensating patients for We propose to remove the would be an average of eight (8) hours providing these services. The current requirement at §§ 482.58(b)(5) and annually for each member of hospital regulatory burden for compliance with 485.645(d)(5) (cross-referenced long-

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term care requirement at § 483.70(p) for psychiatric hospitals with non- P. ICRs Regarding Data Submission, hospital and CAH swing-bed providers physician practitioners and will Clinical Experience, and Outcome to employ a qualified social worker on decrease costs associated with this Requirements for Re-Approval of a full-time basis if the facility has more activity. In accordance with the Transplant Centers (§ 482.82) than 120 beds. Given that this provision information collection request for the Section 482.82 requires that, except as is not applicable to either provider type hospital requirements, which includes specified in § 488.61, transplant centers due to the regulatory requirements for the special requirements for psychiatric must meet all the data submission, each, it does not impose a burden upon hospitals (OMB control number 0938– clinical experience, and outcome hospitals and as such, its removal 0328), no burden is associated with requirements to be re-approved for would not result in a savings of recordkeeping, as the documentation Medicare participation. Section economic burden hours or dollars. At §§ 482.58(b)(8) and 485.645(d)(8) and maintenance of medical records is 482.82(a) requires that no later than 90 (cross-referenced long-term care usual and customary. However, since days after the due date established by requirement at § 483.55(a)(1)) we we believe that clarification of the intent the OPTN, a transplant center must propose to remove the requirement for of the regulation is necessary and will submit to the OPTN at least 95 percent hospital and CAH swing-bed providers result in non-physician practitioners of the required data submissions on all to assist in obtaining routine and 24- (specifically physician assistants, nurse transplants (deceased and living donors) hour emergency dental care to its practitioners, psychologists, and clinical it has performed over the 3 year residents. nurse specialists) documenting the approval period. The required data Under the current CoPs, hospitals and progress notes for patients receiving submissions include, but are not limited CAHs are currently required to address services in psychiatric hospitals, we are to, submission of the appropriate OPTN the emergent dental care needs of their attributing ICR burden savings for this forms for transplant candidate registration, transplant recipient patients at § 482.12(f)(2) for hospitals, provision. For purposes of this analysis registration and follow up, and living and at § 485.618 (emergency services) only, we estimate that MDs/DOs spend donor registration and follow up. for CAHs. As a result, we have approximately 30 minutes documenting calculated the burden associated with Furthermore, § 482.82(b) requires progress notes in psychiatric hospitals. transplant centers to perform an average the provision of routine dental care for We estimate that 33 percent of this time hospital and swing-bed patients. The of 10 transplants per year during the would be covered by non-physician American Dental Association prior 3 years and § 482.82(c) requires practitioners. Of the 5,031 Medicare recommends annual dental checkups for transplant centers to meet the outcome routine dental care for adults over 60 participating hospitals, 574 (or 11 requirements for Medicare re-approval. years of age. With an average length of percent) are psychiatric hospitals. The burden associated with this stay in a hospital or CAH swing-bed of According to AHA, there were requirement would be the time it would 1–2 weeks and an average daily census 35,061,292 inpatient hospital stays in take a transplant program to submit the of 2 patients, we assume that 1 patient 2015, and an estimated 11 percent of required information. However, as receiving swing-bed services will these stays were at psychiatric hospitals. required by §§ 482.72 and 482.45(b), a require routine dental services per The proposed change would result in a hospital in which a transplant program month. While a dentist and dental savings of $62.4 million (3,856,742 is located, must belong to the OPTN, hygienist provide the dental services, psychiatric hospital stays × 0.5 hours of and the OPTN requires that these Medicare is billed for the provision of physician/psychiatrist time × $98 per hospitals submit this data to the OPTN. these services. The costs to the provider hourly wage difference between Therefore, we believe that the are related to the nursing activities physicians/psychiatrists ($198) and requirements under § 482.82 do not associated with the patient receiving the non-physician practitioners ($100, the impose an additional burden on dental services. The current regulatory average wage between nurse transplant programs because all burden for compliance with this practitioners and physician assistants) × Medicare participating transplant requirement is approximately $2.9 33 percent of physician time spent programs are already submitting this million for all hospital and CAH swing- writing progress notes covered by non- information to the OPTN. Removing bed providers, or $1,682 per hospital or physician practitioners). This savings is these requirements will have no CAH swing-bed provider (1,724 hospital additional collection of information equivalent to $108,647 per psychiatric and CAH swing-bed providers × $69 an burden on transplant programs. We hospital per year. hour for a RN × 24 hours per year), describe additional life-saving benefits which are the cost savings to the O. ICRs Regarding Special Requirement that result from the removal of this providers as a result of the removal of for Transplant Centers and Definitions proposal in the subsequent RIA section. this requirement. The information (§§ 482.68 and 482.70) Q. ICRs Regarding Special Procedures collection requests will be revised and for Approval and Re-Approval of Organ sent to OMB for approval (OMB control We are proposing a nomenclature Transplant Centers (§ 488.61(f) Through number 0938–0328 for hospitals and change at part 482 and the transplant (h)) 0938–1043 for CAHs). center regulations at §§ 482.68, 482.70, 482.72 through 482.104, and at § 488.61. Section 488.61(f) through (h) sets out N. ICRs Regarding Special Requirements the process for our consideration of a for Psychiatric Hospitals (§ 482.61(d)) Because this change would update the terminology used in the regulations to transplant center’s mitigating factors in At § 482.61(d) we propose to clarify conform to the terminology that is initial approval and re-approval the requirement allowing non-physician widely used and understood within the surveys, certifications, and enforcement practitioners to document progress transplant community, there are no actions for transplant centers. The notes in accordance with State laws and collection of information requirements provisions also set out definitions and scope of practice requirements. We rules for transplant systems associated with this proposal. believe this would apportion the burden improvement agreements. We are associated with having MDs/DOs proposing to remove the requirements at document their progress notes in § 488.61(f) through (h) for mitigating

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factors and transplant systems approval process. Therefore, we transplant center senior administrator, improvement agreements for the re- estimate that the requirements under and a hospital administrator approval process for transplant centers. § 488.61(f) would require a transplant approximately 5 hours, or 2 hours for This change is complementary to the program to write and submit the initial the medical director and the transplant proposed removal of § 482.82, described formal notice of the program’s intent to program senior administrator and 1 previously. The information collection seek mitigating factors re-approval, and hour for the hospital administrator, to request (OMB Control Number 0938– write and submit a request for complete and submit these mitigating 1069) does not account for any consideration of mitigating factors factors for re-approval, as described in information collection related burden (which would include all of the content Table 2. associated with the requirements in listed in § 488.61(f)(2)). We estimate that § 488.61(f) through (h) for the re- this would take a medical director, a

TABLE 2—ANNUAL BURDEN HOURS AND COST FOR TRANSPLANT PROGRAMS TO SUBMIT MITIGATING FACTORS FOR RE- APPROVAL

Total Position Hourly wage Hours required cost estimate

Medical Director ...... $194 2 $388 Transplant Program Senior Administrator ...... 105 2 210 Hospital Administrator ...... 105 1 105

Totals ...... 5 703

In total, we estimate that an average achieve compliance with the CoPs. The compares policies, procedures, and of 14 programs would submit mitigating agreement would require hospitals to protocols of the transplant program with factors annually. Thus, for those 14 complete certain tasks as listed and those of other programs in areas of programs we estimate that it would described in § 488.61(h)(1), which endeavor that are relevant to the center’s require 70 burden hours (5 burden include (but are not limited to): Patient current quality improvement needs, hours × 14 programs) at a cost of $9,842 notification about the degree and type of amongst other requirements listed in ($703 × 14 programs). In the context of noncompliance by the program, an § 488.61(h)(1)(i) through (x). We this proposed rule, removing this explanation of what the program estimate that this would take a medical requirement would yield an estimated improvement efforts mean for patients director, a transplant program senior savings to transplant programs of 5 and financial assistance to defray the administrator, a hospital administrator, burden hours each and a total of 70 out-of-pocket costs of copayments and and an administrative assistant burden hours for all 14 programs, with testing expenses for any wait-listed approximately 14 hours, or 4 hours for a total cost savings of $9,842. individual who wishes to be listed with the medical director, transplant program In addition, we estimate that the another program, an external senior administrator, and an transplant hospital in conjunction with independent peer review team that administrative assistant, and 2 hours for the transplant program that is located in conducts an onsite assessment of the the hospital administrator to complete the hospital, would submit mitigating program, an action plan that addresses these activities (including notifying factors and then would also enter into systemic quality improvements and is patients about the degree of systems improvement agreements, as updated after the onsite peer review, an noncompliance by mail and organizing described under § 488.61(h) annually. onsite consultant who provides services and completing the other tasks listed in This would require the hospital to enter for 8 days per month on average for the § 488.61(h)(1) as required by the terms into a binding agreement with CMS to duration of the agreement, a in the systems improvement agreement), allow the program additional time to comparative effectiveness analysis that as described in Table 3.

TABLE 3—ANNUAL BURDEN HOURS AND COST FOR TRANSPLANT PROGRAMS TO ENTER INTO A SYSTEMS IMPROVEMENT AGREEMENT FOR RE-APPROVAL

Total Position Hourly wage Hours required cost estimate

Medical Director ...... $194 4 $776 Transplant Program Senior Administrator ...... 105 4 420 Hospital Administrator ...... 105 2 210 Administrative Assistant ...... 34 4 136

Totals ...... 14 1,542

In total, we estimate that an average programs). In the context of this R. ICRs Regarding HHA Home Health of 14 programs will submit mitigating proposed rule, removing this Aide Services (§ 484.80(h)(3)) factors annually. Thus, for those 14 requirement would yield an estimated programs we estimate that it would savings to transplant programs of 14 We propose to eliminate the require 196 burden hours (14 burden burden hours each and a total of 196 requirement at § 484.80(h)(3) that the hours × 14 programs) at a cost of burden hours for all 14 programs, with HHA conduct a full competency $21,588 ($1,542 × 14 transplant a total cost savings of $21,588. evaluation of deficient home health

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aides, and replace it with a requirement in the January 2017 HHA CoP final rule would reduce the current to retrain the aide regarding the (82 FR 4568 and 4575), we believe that documentation requirements (OMB identified deficient skill(s) and require providing such information to patients control number 0938–1091) on CORFs the aide to complete a competency is a usual and customary practice that by 75 percent each year. For the evaluation related only to those skills. does not impose a burden upon HHAs purposes of our analysis, we estimate The content of an aide competency and would not be subject to the PRA in that it would take a CORF examination does not have an accordance with the implementing approximately 8 hours for associated collection of information regulations of the PRA at 5 CFR administrative, clinical and clerical staff requirement. Therefore, this proposed 1320.3(b)(2). As such, removing the to review and evaluate the necessary change would neither impose nor ‘‘next home visit’’ timeframe and efficient use of services provided by remove any collection of information requirement would not result in a the facility on a quarterly basis, for a burdens. savings of burden hours or dollars. total of 32 hours per year per CORF and S. ICRs Regarding HHA Clinical Records T. ICRs Regarding CORF Utilization 6,016 hours for all 188 CORFs. In a (§ 484.110(e)) Review Plan (§ 485.66) 1-year period, we estimate a savings of We propose to remove the We propose to reduce the required $1,644 per facility ($548 × 3 quarters), requirement at § 484.110(e) related to frequency in which CORFs would be and a combined total savings of providing a requested copy of required to complete a ‘‘utilization $309,072 for all CORFs ($1644 × 188 information contained in the clinical review plan’’ from quarterly to annually. CORFs). We will submit the revised record at the next home visit, while Changing from a quarterly information collection request to OMB retaining the requirement to provide the implementation of the utilization review for approval. record within 4 business days. As stated plan to an annual implementation

TABLE 4—CORF—HOURLY WAGES AND BURDEN HOURS

Burden hours Position Hourly wage per Cost estimate per CORF * CORF per CORF

Administrator ...... $105 2 $210 Clerical Staff ...... 32 2 64 Physical Therapist ...... 84 2 168 Social Worker ...... 53 2 106

Total ...... 274 8 548 * Includes 100% fringe benefits & overhead costs.

U. ICRs Regarding CAH Organizational Durable Medical Equipment, ineffective. Our proposed revision of the Structure (§ 485.627(b)(1)) Prosthetics, Orthotics and Supplies patient care policies requirements As of May 2017, there were 1,343 (DMEPOS); Final Rule and Request for imposed on CAHs would reduce the CAHs that are certified by Medicare. Comments (57 FR 2790, June 18, 1992), frequency that is currently required for Our proposed revision of the CAH the burden associated with this CAHs to perform a review of all their disclosure requirements imposed on requirement is 1-hour per facility. As a policies and procedures. We propose CAHs would remove the requirement result, this proposal will save all CAHs that a change from an annual review to for CAHs to disclose to CMS its owners, an estimated $141,000 and will save a biennial review would reduce the or those with a controlling interest in each CAH $105 (1-burden hour for an burden on CAHs by half in a given × the CAH or in any subcontractor in administrator at $105 per hour 1,343 period of time. For the purposes of our which the CAH directly or indirectly CAHs). We will submit the revised analysis, we estimate that it would take has a 5 percent or more ownership information collection request to OMB a CAH approximately 16 hours for interest, in accordance with 42 CFR part for approval (OMB control number administrative and clinical staff to 420, subpart C. While we estimate that 0938–0328). review and make changes to policies and procedures annually. In a 2-year these changes occur at 2 CAHs per year V. ICRs Regarding CAH Provision of period, we estimate a savings of on average between all 1,343 CAHs, Services (§ 485.635(a)(4)) with the vast majority not experiencing $1,956.10 per facility, and a combined any such changes throughout the Section 485.635(a)(4) requires CAHs total savings of $2.6 million for CAHs lifetime of the CAH, each CAH is still to conduct an annual review of all its ($1,956.10 × 1,343 CAHs). required to review the duplicative policies and procedures. Based on We estimate that the CAH staff time documentation. In accordance with feedback from stakeholders, the and associated costs would be assigned Medicare Program; Criteria and prescriptive annual schedule is to a biennial review as shown in Table Standards for Evaluating Regional burdensome or, in some situations, 5.

TABLE 5—HOURLY WAGES AND BURDEN HOURS

Hourly wage Burden hours Cost estimate Position per CAH per CAH per CAH

Administrator ...... $186.88 4 $747.52 Clerical staff ...... 38.78 3 116.34 Registered Nurse ...... 69.40 3 208.20

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TABLE 5—HOURLY WAGES AND BURDEN HOURS—Continued

Hourly wage Burden hours Cost estimate Position per CAH per CAH per CAH

Nurse practitioner ...... 100.60 3 301.80 Physician ...... 194.08 3 582.24

Totals ...... 589.74 16 1,956.10

W. ICRs Regarding Special with the commenter that the 30 day Y. ICRs Regarding Portable X-Ray Requirements for CAH Providers of requirement does, in fact, impose a Services (§§ 486.104(a) and 486.106(a)) Long-Term Care Services (‘‘Swing- burden and is not usual and customary We propose to revise the requirements Beds’’) (§ 485.645(d)(1), (4), (5) and (8)) practice. Therefore, removing this for portable x-ray technologist personnel We have included the discussion of requirement would reduce information qualifications at § 486.104 to align the the ICRs regarding special requirements collection burden for CMHCs. current requirements at § 486.104(a)(1), for CAH providers of long-term care Under the current 30-day time frame (2), (3), and (4) with those for hospital services in the discussion of the ICRs requirement, each client receives an radiologic technologists at § 482.26(c)(2) regarding special requirements for updated assessment 12 times per year. which are focused on the qualifications hospital providers of long-term care We estimate that, in accordance with of the individual performing services as services which can be found under the proposed need-based assessment permitted by State law. Although section L of this part. update requirements, each non-PHP changing the qualifications would require management time, with the X. ICRs Regarding CMHCs (§ 485.914(d)) client would receive 2 assessment updates in a year. Therefore, we associated cost of those hours, in order Section 485.914(d)(1) requires each estimate that this change would reduce to revise the internal personnel CMHC to update each client’s the burden of 10 assessments per client, descriptions and qualifications, we comprehensive assessment via the per year. believe that this proposed change would CMHC interdisciplinary treatment team, impose no burden because maintaining in consultation with the client’s primary As of August 2017 there are 52 internal personnel descriptions and health care provider (if any), no less Medicare participating CMHCs serving qualifications is a standard business frequently than every 30 days. We 3,122 Medicare beneficiaries and an practice. Therefore, this burden would propose to modify the requirement at estimated 2,080 non-Medicare clients, not be subject to the PRA in accordance § 485.914(d) to remove the 30-day for an average of 100 clients per CMHC. with the implementing regulations of assessment update time frame for those In order to develop the estimated the PRA at 5 CFR 1320.3(b)(2). clients who do not receive PHP services. number of non-Medicare clients we We propose to revise the requirements Instead of a fixed 30-day time frame, divided the total number of Medicare for portable x-ray orders at assessment updates would be completed beneficiaries who received partial § 486.106(a)(2). We propose to remove when changes in the client’s status, hospitalization services by the total the requirement that physician or non- responses to treatment, or goal number of Medicare-participating physician practitioner’s orders for achievement have occurred, and in CMHCs to establish the average number portable x-ray services must be written accordance with current standards of of Medicare beneficiaries per CMHC. and signed. We also propose to replace practice. The burden associated with This resulted in 60 beneficiaries per the specific requirements related to the these requirements is the time required CMHC. We then assumed that, in order content of each portable x-ray order to record an updated assessment. The to comply with the 40 percent with a cross-reference to the current information collection request requirement (§ 485.918(b)(1)(v)), those requirements at 42 CFR 410.32, which (OMB Control number 0938–1245) does 60 beneficiaries only accounted for 60 also apply to portable x-ray services. not account for any information percent of an average CMHC’s total These proposed changes would simplify collected related to the burden patient population. This means that an the ordering process for portable x-rays associated with updating the average CMHC also treated another 40 and promote the use of more efficient comprehensive assessment requirement. clients who did not have Medicare as a ordering methods, such as electronic While in the past we believed that this payer source, for a total of 100 clients orders. is considered usual and customary (Medicare + non-Medicare) in an This change would allow for portable practice, recent comments from the average CMHC. Therefore, all CMHCs x-ray services to be ordered in writing, CMHC provider community, submitted combined would have approximately by telephone, or by electronic methods. in response to CMS’ solicitation for 2,080 non-PHP clients per year (40 per The change would also streamline the public comments pertaining to burden CMHC), and approximately 20,800 ordering process by avoiding the need to reduction suggestions, stated that it is assessments would be reduced write two separate orders for the same not usual and customary to update nationwide per year (2,080 patients × 10 study, one to meet the Medicare assessments for non-PHP clients on a 30 assessments per patient). We estimate payment requirements in accordance day schedule as required by the CMHC that documenting each assessment with § 410.32 and its associated Manual regulations. The commenters stated that update requires 10 minutes of a CMHC guidance, and another to meet the the 30 day requirement was overly clinician’s time, for a total savings of content requirements of the regulation burdensome, and suggested that the 3,466 hours nationwide (1,666 hours × set forth at § 486.106. We believe the CMHC assessment update requirement 20,800 assessment updates). At a cost of proposed change would allow for should more closely align with the $7.33 for a mental health counselor to additional ordering flexibility to patient-oriented approach of other document each assessment, the total streamline ordering practices. In the entities that govern CMHC operations. cost savings would be $152,464 ($7.33 information collection request (OMB Upon further consideration, we agreed × 20,800 assessments). control number 0938–0338) we estimate

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that the current order requirements Z. ICRs Regarding RHC and FQHC period of time. In the currently would impose the following burdens: Provision of Services (§ 491.9(b)(4)) approved information collection request • 3 minutes to write an order × There are currently more than 4,100 (OMB control number 0938–0334), we 3,986,000 portable x-rays exams ordered RHCs and approximately 1,400 FQHC estimate that it would take a RHC or = 199,300 hours × $69/hour for a nurse organizations furnishing services at FQHC approximately 4 hours for = $13,751,700. approximately 12,000 or more total clinical staff to review and make locations. Many FQHC organizations changes to policies and procedures • $1 for printing and faxing verbal have multiple delivery sites, so to be as annually, for a total of 48,136 hours for orders to physician offices for signature accurate as possible, our burden all 12,034 RHC and FQHC locations. In × 2,500,000 verbal orders = $2,500,000. reduction calculations are based on the a 2-year period, RHCs and FQHCs • 2,000,000 follow-up calls regarding most recent data available, which shows would use 96,272 total hours to comply the status of faxes × 10 minutes of time that as of May 2017, there were 4,160 with the requirements to annually for clerical staff (5 minutes for portable RHCs and 7,874 FQHC delivery sites. review all of their policies and x-ray clerical staff + 5 minutes for All CMS-certified sites are subject to our procedures. Under the proposed change ordering physician clerical staff) = requirements and we are therefore to a review every other year, we 333,333 hours × $32/hour = utilizing the total number of current estimate that in a 2-year period, it will sites in our burden reduction $10,666,656. take a total of 48,136 hours, for a savings calculations. All of these burdens would be We propose to revise § 491.9(b)(4) to of 48,136 hours per year. We estimate a eliminated by revising the current reduce the number of times that RHCs savings of $592 per facility (see Table 6) ordering standards. Therefore, we and FQHCs perform a review of all their for a combined total savings of $7.1 estimate a proposed information policies and procedures. Changing from million for 12,034 RHCs or FQHCs × collection savings of $26,918,356 from an annual review to a review every ($592 12,034 RHCs and FQHCs). We this proposed change. other year would reduce the burden on will submit a revised information RHCs and FQHCs by half in a given collection request to OMB for approval.

TABLE 6—HOURLY WAGES AND BURDEN HOURS

Hourly wage per RHC/FQHC Burden hours Cost estimate Position (Includes per per 100% benefit RHC/FQHC RHC/FQHC package)

Physician ...... $198 2 $396 Mid-Level Provider (PA or NP) ...... 98 2 196

Total ...... 296 4 592

AA. ICRs Regarding RHC and FQHC currently approved information comply with the requirement for an Program Evaluation (§ 491.11(a)) collection request (OMB control number evaluation of the total program. Under We propose to revise § 491.11(a) to 0938–0334), we estimate that it would the proposed change to evaluate the reduce the number of times that RHCs take a RHC or FQHC approximately 6 total program every other year, we and FQHCs carry out or arrange for an hours for administrative and clinical estimate a hourly savings of 72,204 total annual evaluation of the total program. staff to perform an evaluation of its total hours and a cost savings of $802 per Changing from an annual evaluation to program annually for a total of 72,204 facility (see Table 7), for a combined an evaluation every other year would hours for all 12,034 RHC and FQHC total savings of $9.7 million for 12,034 reduce the burden on RHCs and FQHCs locations. In a 2-year period, RHCs and RHCs or FQHCs ($802 × 12,034 RHC by half in a given period of time. In the FQHCs would use 144,408 total hours to and FQHC locations).

TABLE 7—HOURLY WAGES AND BURDEN HOURS

Hourly wage per RHC/FQHC Burden hours Cost estimate Position (Includes per RHC/ per 100% benefit FQHC RHC/FQHC package)

Administrator/Health Services Manager ...... $105 2 $210 Physician ...... 198 2 396 Mid-Level Provider (PA or NP) ...... 98 2 196.00

Total ...... 401 6 802

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BB. ICRs Regarding Emergency $44 per hour) × 18 RNHCIs × 50 hour plus 8 burden hours for a nursing Preparedness for Providers and percent). director at $105 per hour plus 8 burden Suppliers • ASCs: Combined total savings of hours for a director of rehab at $84 per $6,134,928 for 5,557 ASCs ((8 burden hour plus 4 burden hours for an office 1. Review of the Emergency hours for an administrator at $108 per manager at $56 per hour) × 12,624 Preparedness Program hour plus 4 burden hours for a HHAs × 50 percent). At § 482.15(a), (b), (c), and (d) for physician at $198 per hour plus 8 • CORF: Combined total savings of hospitals and parallel regulatory burden hours for a quality improvement $142,128 for 188 CORFs ((8 burden citations for other facilities, we propose RN at $69 per hour) × 5,557 ASCs × 50 hours for an administrator at $105 per to allow providers to review their percent). hour plus 8 burden hours for a physical program at least every 2 years. As of • Hospices: Combined total savings of therapist at $84 per hour) × 188 CORFs May 2017, there were approximately $5,781,832 for 4,489 hospice facilities × 50 percent). 74,246 total facilities. All are required to ((8 burden hours for an administrator at • CAH: Combined total savings of review their emergency preparedness an hourly wage of $105 per hour plus $1,643,832 for 1,343 CAHs ((8 burden program annually, which includes a 4 burden hours for a physician at $198 hours for an administrator at $105 per review of their emergency plan, policies per hour plus 4 burden hours for a hour plus 8 burden hours for a director and procedures, communication plan, counselor at $44 per hour plus 4 burden of nursing at $105 per hour plus 8 and training and testing program. hours for a social worker at $54 per hour burden hours for a facility director at For our analysis, we estimate that plus 8 burden hours for a RN at $69 per $96 per hour) × 1,343 CAHs × 50 × × reducing this requirement from hour) 4,489 hospices 50 percent). percent). annually to biennially would reduce • PRTFs: Combined total savings of • Organizations: Combined total compliance costs related to review of $556,512 for 374 PRTFs ((8 burden savings of $1,220,688 for 2,076 the emergency plan by 50 percent. The hours for an administrator $105 per our Organizations ((8 burden hours for an methodology used for our cost estimate plus 8 burden hours for a physician at administrator at $105 per hour plus 4 analysis generally mirrors the $198 per hour plus 8 burden hours for burden hours for a physical therapist at methodology used for the annual review × × a RN at $69 per hour) 374 PRTFs 50 $84 per hour) × 2,076 Organizations × of the emergency plan Emergency percent). • 50 percent). Preparedness final rule (81 FR 63930) PACE: Combined total savings of • with a 50 percent reduction in the cost $226,476 for 233 PACE organizations ((8 CMHCs: Combined total savings of estimate calculation; however, after burden hours for an administrator at $146,832 for 161 CMHCs ((8 burden receiving additional feedback from $105 per hour plus 8 burden hours for hours for an administrator at $105 per stakeholders, we have determined that a home care coordinator at $69 per hour hour plus 8 burden hours for a RN at we underestimated the amount of time plus 8 burden hours for a RN at $69 per $69 per hour plus 8 burden hours for a × × social worker at $54 per hour) × 161 it would take to review the emergency hour) 233 PACE organizations 50 × plan. As a result, we have presented CMHCs 50 percent). percent). • current burden hours associated with • Hospitals: Combined total savings OPOs: Combined total savings of reviewing the emergency plan that of $11,933,532 for 5,031 hospitals ((8 $119,016 for 58 OPOs ((8 burden hours reflects the increased associated burden burden hours for an administrator at for an OPO director at $105 per hour hours relative to the information $108 per hour plus 8 burden hours for plus 8 burden hours for a physician at collection request for this provision a physician at $198 per hour plus 8 $198 per hour plus 8 burden hours for (OMB control number 0938–1325). As burden hours for a risk management a QAPI director at $105 per hour plus in the Emergency Preparedness final director at $105 per hour plus 8 burden 8 burden hours for an organ rule (81 FR 63930), we assume that the hours for a quality assurance nurse at procurement coordinator at $105 per × × individuals involved in the review of $69 per hour plus 8 burden hours for a hour) 58 OPOs 50 percent). • the emergency plan include an facility director at $96 per hour plus 4 RHC/FQHC: Combined total savings administrator, director of nursing, a RN, burden hours for a medical secretary at of $9,916,016 ((8 burden hours for an a physician, a social worker, a $34 per hour) × 5,031 hospitals × 50 administrator at $105 per hour plus 8 counselor, and an office manager, percent). burden hours for a nurse practitioner/ × depending on the facility type. Based on • LTCF: Combined total savings of physician assistant at $101 per hour) × May 2016 BLS salary data, we $25,562,016 for 15,663 LTCF facilities 4,160 RHCs 50 percent) $3,427,840 + calculated the hourly mean wage for ((8 burden hours for an administrator at ((8 burden hours for an administrator at each position for this requirement $105 per hour plus 8 burden hours for $105 per hour plus 8 burden hours for identified in the Emergency a physician at $198 per hour plus 8 a nurse practitioner/physician assistant × × Preparedness final rule (81 FR 63930). burden hours for a director of nursing at at $101 per hour 7,874 FQHCs 50 We estimate that the proposed change $105 per hour) × 15,663 LTCFs × 50 percent) $6,488,176). will accrue a total annual cost savings percent). • ESRD Facilities: Combined total of $94,312,719 and 187 burden hours • ICF/IID: Combined total savings savings of $11,064,392 for 6,898 dialysis saved. We list a detailed calculation for $3,402,126 for 6,097 ICF/IIDs ((8 burden facilities ((8 burden hours for an each facility below, based on facility hours for an administrator at $105 per administrator at $105 per hour plus 8 numbers available as of May 2017: hour plus 4 burden hours for a RN $69 burden hour for a medical director/ • RNHCIs: Combined total savings of per hour) × 6,097 ICF/IIDs × 50 percent). physician at $198 per hour plus 8 $9,540 for 18 RNHCIs ((8 burden hours • HHA: Combined total savings of burden hours for a nurse manager at for an administrator at $105 plus 5 $16,259,712 for 12,624 HHAs ((8 burden $105) × 6,898 dialysis facilities × 50 burden hours for a director of nursing at hours for an administrator at $105 per percent) as shown in Table 8.

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TABLE 8—COST SAVINGS FOR ANNUAL REVIEW OF EMERGENCY PREPAREDNESS PLAN

Cost savings Provider/supplier per provider/ Combined total savings supplier

RNHCIs ...... $530 $9,540 for 18 RNHCIs. ASCs ...... 1,104 $6,134,928 for 5,557 ASCs. Hospices ...... 1,288 $5,781,832 for 4,489 hospice facilities both inpatient and freestanding/home based. PRTFs ...... 1,488 $556,512 for 374 PRTFs. PACEs ...... 972 $226,476 for 233 PACEs. Hospitals ...... 2,372 $11,933,532 for 5,031 hospitals. LTCFs ...... 1,632 $25,562,016 for 15,663 LTCFs. ICFs/IIDs ...... 558 $3,402,126 for 6,097 ICF/IIDs. HHAs ...... 1,288 $16,259,712 for 12,624 HHAs. CORFs ...... 756 $142,128 for 188 CORFs. CAHs ...... 1,224 $1,643,832 for 1,343 CAHs. Organizations ...... 588 $1,220,688 for 2,076 Organizations. CMHCs ...... 912 $146,832 for 161 CMHCs. OPOs ...... 2,052 $119,016 for 58 OPOs. RHCs/FQHCs ...... 824 $9,916,016 for RHCs and FQHCs ($3,427,840 for 4,160 RHCs and $6,488,176 for 7,874 FQHCs). ESRD Facilities ...... 1,6332 $11,257,536 for 6,898 dialysis facilities.

2. Contents of the Emergency Plan accredited ASCs, TJC-accredited CAHs, administrator, a PACE Program Director, and TJC-accredited hospitals have or QAPI director and a cost savings of At § 482.15(a)(4) for hospitals, and emergency preparedness requirements $105 per facility for RNHCIs, non-TJC other parallel citations for the facilities for developing an emergency accredited ASCs, hospices (both mentioned in section II.J.2 of this preparedness plan that are comparable inpatient and freestanding), PRTFs, proposed rule, we propose to eliminate to the current emergency preparedness PACEs, LTCFs, ICF/IIDs, HHAs, CORFs, the requirement that facilities document CoPs (81 FR 63937, 63954, and 63978 non-TJC accredited CAHs, efforts to contact local, tribal, regional, through 63979). Utilizing the same Organizations, CMHCs, OPOs, RHC/ State, and Federal emergency assumptions we used in the Emergency FQHCs, and dialysis facilities ($105 preparedness officials and that facilities Preparedness final rule (81 FR 63937, hourly mean wage × 1 burden hour). For document participation in collaborative 63954, and 63978 through 63979), we non-TJC accredited hospitals, we and cooperative planning efforts. We estimate that cost savings will estimate that an administrator, or in the accumulate from non-TJC accredited estimate an hourly mean wage of $114 case of a hospital a community relations for a community relations manager, and ASC, CAHs, and hospitals, since TJC- × manager, a program director for a PACE, accredited ASCs, CAHs and hospitals a $114 cost per facility ($114 1 hour). or a QAPI director for OPOs, would take are already required by the TJC to Therefore, we estimate the following for 1 hour to document efforts to contact develop emergency preparedness plans. each facility affected by the proposed local, tribal, regional, State and Federal As a result, these facilities are excluded change, for a total savings of $7,179,117 emergency preparedness officials and, from the analysis given the and 18 burden hours. We list a summary when applicable, document the requirements of their accreditation of the calculation for savings accrued by facility’s participation in collaborative organization standards. Based on May removing this requirement for each and cooperative planning efforts. We 2016 BLS salary data, we calculate an facility in Table 9, based on facility note that the Joint Commission (TJC)- hourly mean wage of $105 for an numbers available as of May 2017.

TABLE 9—COST SAVINGS: DOCUMENTATION OF THE FACILITY’S PARTICIPATION IN COLLABORATIVE AND COOPERATIVE PLANNING EFFORTS

Cost savings Provider/supplier per provider/ Combined total savings supplier

RNHCIs ...... $105 $1,890 for 18 RNHCIs. ASCs (Non-TJC accredited) ...... 105 $522,375 for 4,975 non-TJC accredited ASCs. Hospices ...... 105 $471,345 for 4,489 hospice facilities both inpatient and freestanding/home based. PRTFs ...... 105 $39,270 for 374 PRTFs. PACEs ...... 105 $24,465 for 233 PACEs. Hospitals (Non-TJC accredited) ...... 114 $157,662 for 1,383 non-TJC accredited hospitals. LTCFs ...... 105 $1,644,615 for 15,663 LTCFs. ICFs/IIDs ...... 105 $640,185 for 6,097 ICF/IIDs. HHAs ...... 105 $1,325,520 for 12,624 HHAs. CORFs ...... 105 $19,740 for 188 CORFs. CAHs (Non-TJC accredited) ...... 105 $103,215 for 983 non-TJC accredited CAHs. Organizations ...... 105 $217,980 for 2,076 Organizations. CMHCs ...... 105 $16,905 for 161 CMHCs. OPOs ...... 105 6,090 for 58 OPOs. RHCs/FQHCs ...... 105 $1,263,570 for RHCs and FQHCs ($436,800 for 4,160 RHCs and $826,770 for 7,874 FQHCs).

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TABLE 9—COST SAVINGS: DOCUMENTATION OF THE FACILITY’S PARTICIPATION IN COLLABORATIVE AND COOPERATIVE PLANNING EFFORTS—Continued

Cost savings Provider/supplier per provider/ Combined total savings supplier

ESRD Facilities ...... 105 $724,290 for 6,898 dialysis facilities.

3. Training We estimate that the proposed change • LTCF: Combined total savings of will accrue a total annual cost savings $8,223,075 for 15,663 LTCFs (2 burden At § 482.15(d)(1)(ii) for hospitals, and of $33,267,864 and 111 burden hours. hours for an administrator at $105 per other parallel citations for other We list a detailed calculation for each hour plus 8 burden hours for a director facilities mentioned in section II.J.2 of facility below, based on facility numbers of nursing at $105 per hour × 15,663 this proposed rule, we propose to available as of May 2017 with a LTCFs × 50 percent). require that facilities provide training summary of these calculations provided • ICF/IID: Combined total savings biennially, or every 2 years, after in Table 10: $1,691,918 for 6,097 ICF/IIDs (2 burden facilities conduct initial training on • RNHCIs: Combined total savings of hours for an administrator at $105 per their emergency program. In addition, $3,870 for 18 RNHCIs ((2 burden hours hour plus 5 burden hours for a RN $69 we propose to require additional for an administrator at $105 plus 5 per hour × 6,097 ICF/IIDs × 50 percent). training when the emergency plan is burden hours for a director of nursing at • HHA: Combined total savings of significantly updated. We believe that $44 per hour) × 18 RNHCIs × 50 $7,902,624 for 12,624 HHAs (2 burden the annual training requirement is too percent). hours for an administrator at $105 per prescriptive as annual may not always • ASCs: Combined total savings of hour plus 2 burden hours for a nursing be necessary. We propose to maintain $1,258660 for 5,557 ASCs ((1 burden director at $105 per hour plus 2 burden the requirement that providers and hour for an administrator at $108 per hours for a director of rehab at $84 per suppliers develop a well-organized, hour plus 5 burden hours for a quality hour plus 2 burden hours for an office effective training program that includes improvement RN at $69 per hour) × manager at $56 per hour plus 8 burden initial training for new and existing staff 5,557 ASCs × 50 percent). hours for a director of training at $69 × in emergency preparedness policies and • Hospices: Combined total savings of 12,624 HHAs × 50 percent). procedures and would require training $929,223 for 4,489 hospice facilities (6 • CORF: Combined total savings of when the emergency plan is burden hours for a RN at $69 per hour $73,038 for 188 CORFs (5 burden hours significantly updated. Facilities would × 4,489 hospices × 50 percent). for an administrator at $105 per hour have the flexibility to determine what is • PRTFs: Combined total savings of plus 3 burden hours for a physical considered a significant update to the $129,030 for 374 PRTFs (10 burden therapist at $84 per hour × 188 CORFs emergency plan. hours for a RN at $69 per hour × 374 × 50 percent). For our analysis, we estimate that PRTFs × 50 percent). • CAH: Combined total savings of reducing this requirement from • PACE: Combined total savings of $968,974 for 1,343 CAHs (2 burden annually to biennially will reduce $96,462 for 233 PACE organizations (3 hours for an administrator at $105 per compliance costs related to providing burden hours for a home care hour plus 9 burden hours for a director emergency preparedness training by 50 coordinator at $69 per hour plus 9 of nursing at $105 per hour plus 3 percent. The methodology used for our burden hours for a RN at $69 per hour burden hours for a facility director at cost estimate analysis mirrors the × 233 PACE organizations × 50 percent). $96 per hour × 1,343 CAHs × 50 • methodology used for the annual Hospitals: As we stated in the percent). training requirement in the Emergency Emergency Preparedness final rule (81 • Organizations: Combined total Preparedness final rule (81 FR 63930) FR 63958), TJC-accredited hospitals are savings of $828,324 for 2,076 with a 50 percent reduction in the cost required to train their staff for their Organizations (6 burden hours for an estimate calculation. As in the assigned roles during emergencies administrator at $105 per hour plus 2 Emergency Preparedness final rule (81 (CAMH, Standard EC.4.16, Eps 1–2, p. burden hours for a physical therapist at FR 63930), we assume that the EC–13e). In addition, the TJC-accredited $84 per hour × 2,076 Organizations × 50 individuals involved in the hospitals also must provide on-going percent). development and provision of training training to their staff, including training • CMHCs: Combined total savings of include an administrator, director of on specific job-related safety (CAMH, $55,545 for 161 CMHCs (10 burden nursing, a RN, and an office manager, Standard HR–2.30, EP 4, CAMH hours for a psychiatric RN at $69 per depending on the facility type. Refreshed Core, January 2008, p. HR– hour × 161 CMHCs × 50 percent). Providers and suppliers are expected to 11), and we expect that emergency • OPOs: Combined total savings of provide initial training in emergency preparedness is part of such on-going $111,012 for 58 OPOs (2 burden hours preparedness policies and procedures to training. As a result, we estimate a for a director at $114 per hour plus 2 all new and existing staff, individuals combined total savings of $2,015,031 for burden hours for a medical director/ providing services under arrangement, 1,383 non-TJC accredited hospitals (2 physician at $198 per hour plus 12 and volunteers, consistent with their burden hours for an administrator at burden hours for a QAPI director at expected roles, and maintain $108 per hour plus 6 burden hours for $105 per hour plus 8 hours for an organ documentation of the training. Based on a risk management director at $105 per procurement coordinator at $105 per May 2016 BLS salary data, we hour plus 28 hours for a healthcare hour plus 16 burden hours for an calculated the hourly mean wage for trainer (RN) at $69 per hour plus 4 education coordinator at $69 per hour × each position for this requirement burden hours for a medical secretary at 58 OPOs × 50 percent). identified in the Emergency $34 per hour × 1,383 hospitals × 50 • RHC/FQHC: Combined total savings Preparedness final rule (81 FR 63930). percent). of $6,125,306 ((2 burden hours for an

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administrator at $105 per hour plus 8 a nurse practitioner/physician assistant administrator at $105 per hour plus 1 burden hours for a nurse practitioner/ at $101 per hour × 7,874 FQHCs × 50 burden hour for a medical director/ physician assistant at $101 per hour × percent) $4,007,866). physician at $198 per hour plus 3 4,160 RHCs × 50 percent) $2,117,440 + • ESRD Facilities: Combined total burden hours for a nurse manager at (2 burden hours for an administrator at savings of $2,855,772 for 6,898 dialysis $105 × 6,898 dialysis facilities × 50 $105 per hour plus 8 burden hours for facilities (3 burden hours for an percent).

TABLE 10—COST SAVINGS: TRAINING

Cost savings Provider/supplier per provider/ Combined total savings supplier

RNHCIs ...... $215 $3,870 for 18 RNHCIs. ASCs ...... 226 $1,258,660 for 5,557 ASCs. Hospices ...... 207 $929,223 for 4,489 hospice facilities both inpatient and freestanding/home based. PRTFs ...... 345 $129,030 for 374 PRTFs. PACEs ...... 414 $96,462 for 233 PACE organizations. Hospitals (Non-TJC accredited) ...... 1,457 $2,015,031 for 1,383 non-TJC accredited hospitals. LTCFs ...... 525 $8,223,075 for 15,663 LTCFs. ICFs/IIDs ...... 278 $1,691,918 for 6,097 ICF/IIDs. HHAs ...... 626 $ 7,902,624 for 12,624 HHAs. CORFs ...... 389 $73,038 for 188 CORFs. Organizations ...... 399 $828,324 for 2,076 Organizations. CAHs ...... 721 $968,974 for 1,343 CAHs. CMHCs ...... 345 $55,545 for 161 CMHCs. OPOs ...... 1,914 $1111,012 for 58 OPOs. RHCs/FQHCs ...... 509 $6,125,306 for RHCs and FQHCs ($2,117,440 for 4,160 RHCs and $4,007,866 for 7,874 FQHCs). ESRD Facilities ...... 414 $2,855,772 for 6,898 dialysis facilities.

4. Testing available), a facility-based functional summary of these calculations provided in Table 11: Finally, at § 482.15(d)(2), we propose exercise, a drill, or a tabletop exercise or • ASCs: Combined total savings of to require that providers of inpatient workshop that includes a group $1,066,944 for 5,557 ASCs ((1 burden services mentioned in section II.J.2 of discussion led by a facilitator. For our analysis, we estimate that hour for an administrator at $108 per this proposed rule conduct two testing hour plus 4 burden hours for a quality exercises annually, one of which may be reducing this requirement from × biannually to annually for outpatient improvement RN at $69 per hour) an exercise of their choice that must be 5,557 ASCs × 50 percent). either a community-based full-scale providers will reduce compliance costs • related to conducting emergency Freestanding/home-based hospices: exercise (if available), an individual Combined total savings of $557,520 for facility-based functional exercise, a preparedness testing by 50 percent. The methodology used for our cost estimate 4,040 hospice facilities (4 burden hours drill, a tabletop exercise or workshop for a RN at $69 per hour × 4,040 that includes a group discussion led by analysis mirrors the methodology used × for the biannual testing requirement in hospices 50 percent). a facilitator. We estimate that revising • PACE: Combined total savings of the Emergency Preparedness final rule this requirement to include additional $40,193 for 233 PACE organizations (4 (81 FR 63930) with a 50 percent options for the types testing exercises burden hours for a home care reduction in the cost estimate that may be conducted for one of the coordinator at $69 per hour plus 1 calculation. As in the Emergency two annually required exercises will burden hours for a RN at $69 per hour Preparedness final rule (81 FR 63930), provide greater flexibility for these × 233 PACE organizations × 50 percent). providers. Given that these providers we will assume that the same • HHA: Combined total savings of are currently required to conduct two individuals involved with developing $3,970,248 for 12,624 HHAs (1 burden testing exercises annually, and because training would typically also develop hour for an administrator at $105 per they may choose to conduct the same the scenarios, materials, as well as any hour plus 3 burden hours for a nursing types of testing exercises, we do not accompanying documentation director at $105 per hour plus 1 burden anticipate that this requirement will associated with testing exercises. Based hours for a director of rehab at $84 per impose a burden upon providers of on May 2016 BLS salary data, we hour plus 1 burden hour for an office inpatient services and as such, this calculated the hourly mean wage for manager at $56 per hour plus 1 burden revision would not result in a savings of each position for this requirement hours for a director of training at $69 × burden hours or dollars. identified in the Emergency 12,624 HHAs × 50 percent). We propose to require that providers Preparedness final rule (81 FR 63930) • CORF: Combined total savings of of outpatient services mentioned in and decreased the cost by 50 percent $55,272 for 188 CORFs (4 burden hours section II.J.2 of this proposed rule due to the 50 percent reduction in the for an administrator at $105 per hour conduct one testing exercise annually frequency requirement. plus 2 burden hours for a physical which must be either a community- We estimate that the proposed change therapist at $84 per hour × 188 CORFs based full-scale exercise (if available) or will accrue a total annual cost savings × 50 percent). an individual facility-based functional of $9,117,425 and 25 burden hours. We • Organizations: Combined total exercise every other year, and in the list a detailed calculation for each savings of $305,172 for 2,076 opposite years, may be either a facility below, based on facility numbers organizations (2 burden hours for an community-based full-scale exercise (if available as of May 2017 with a administrator at $105 per hour plus 1

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burden hour for a physical therapist at coordinator at $69 per hour × 58 OPOs • ESRD: As identified in the $84 per hour × 2,076 organizations × 50 × 50 percent). Emergency Preparedness final rule (81 percent). • RHC/FQHC: Combined total savings FR 64006), the current CFCs already of $3,086,721 ((2 burden hours for an • CMHCs: Combined total savings of require dialysis facilities to evaluate administrator at $105 per hour plus 3 $22,218 for 161 CMHCs (4 burden hours their emergency preparedness plan at × burden hours for a nurse practitioner/ least annually (§ 494.60(d)(4)(ii)); thus, for a psychiatric RN at $69 per hour physician assistant at $101 per hour × 161 CMHCs × 50 percent). × we expect that all dialysis facilities are 4,160 RHCs 50 percent) + (2 burden already conducting some type of tests to • OPOs: Combined total savings of hours for an administrator at $105 per evaluate their emergency preparedness $12,673 for 58 OPOs (3 burden hours for hour plus 3 burden hours for a nurse plans. As a result, ESRDs are not a QAPI director at $105 per hour plus practitioner/physician assistant at $101 included in the burden calculation. 2 burden hours for an education per hour × 7,874 FQHCs × 50 percent)).

TABLE 11—COST SAVINGS: TESTING

Cost savings Provider/supplier per provider/ Combined total savings supplier

ASCs ...... $192 $1,066,944 for 5,557 ASCs. Hospices (freestanding/home-based) ...... 138 $557,520 for 4,040 hospices. PACEs ...... 173 $40,193 for 233 PACE organizations. HHAs ...... 314 $3,970,248 for 12,624 HHAs. CORFs ...... 294 $55,272 for 188 CORFs. Organizations ...... 147 $305,172 for 2,076 Organizations. CMHCs ...... 138 $22,218 for 161 CMHCs. OPOs ...... 226 $13,137 for 58 OPOs. RHCs/FQHCs ...... 256 $3,086,721 ($1,067,040 for 4,160 RHCs and $2,019,681 for 7,874 FQHCs).

We will submit a revised information better outcomes for patients while This proposed rule is not just a collection request to OMB to account for reducing burden on providers of care, continuation of our efforts to reduce the burden hour and cost savings. and we identified non-regulatory regulatory burden but also directly changes that would increase responds to the January 30, 2017 IV. Response to Comments transparency and allow CMS to become Executive Order ‘‘Reducing Regulation Because of the large number of public a better business partner. In accordance and Controlling Regulatory Costs’’ comments we normally receive on with these goals, we published three (Executive Order 13771). We propose Federal Register documents, we are not final rules that identified unnecessary, changes to the current CoPs or CfCs that able to acknowledge or respond to them obsolete, or excessively burdensome will simplify and streamline the current individually. We will consider all regulations on health care providers, regulations and thereby increase comments we receive by the date and suppliers, and beneficiaries. These rules provider flexibility and reduce time specified in the DATES section of further increased the ability of health excessively burdensome regulations, this preamble, and, when we proceed care professionals to devote resources to while also allowing providers to focus with a subsequent document, we will improving patient care by eliminating or on providing high-quality healthcare to respond to the comments in the reducing requirements that impede their patients. This proposed rule will preamble to that document. quality patient care or that divert also reduce the frequency of certain V. Regulatory Impact Analysis providing high quality patient care: required activities and, where • ‘‘Reform of Hospital and Critical appropriate, revise timelines for certain A. Statement of Need Access Hospital Conditions of requirements for providers and All major and many ostensibly minor Participation’’, published May 16, 2012 suppliers and remove obsolete, government regulations should undergo (77 FR 29034); duplicative, or unnecessary periodic review to ensure that they do • ‘‘Regulatory Provisions to Promote requirements. Ultimately, these not unduly burden regulated entities or Program Efficiency, Transparency, and proposals balance patient safety and the American people, and reflect current Burden Reduction’’, published May 16, quality, while also providing broad knowledge as to regulatory effects. In 2012 (77 FR 29002) and; regulatory relief for providers and recent years, we have revised the CoPs suppliers, and reducing the associated • ‘‘Regulatory Provisions to Promote and CfCs to reduce the regulatory burden on patients. burden on providers and suppliers. In Program Efficiency, Transparency, and doing so, we identified obsolete and Burden Reduction; Part II’’, published B. Overall Impact burdensome regulations that could be May 12, 2014 (79 FR 27105). We have examined the impacts of this eliminated or reformed to improve These reforms, however, did not rule as required by Executive Order effectiveness or reduce unnecessary exhaust the potential for burden- 12866 on Regulatory Planning and reporting requirements and other costs, reducing reforms. We have continued to Review (September 30, 1993), Executive with a particular focus on freeing up consult with regulated entities, have Order 13563 on Improving Regulation resources that health care providers, reviewed new research findings, have and Regulatory Review (January 18, health plans, and States could use to reviewed comments on previous 2011), the Regulatory Flexibility Act improve or enhance patient health and rulemakings, and in these and other (RFA) (September 19, 1980, Pub. L. 96– safety. We also examined policies and ways have identified additional reforms. 354), section 1102(b) of the Social practices not codified in rules that could These reforms are addressed in this Security Act, section 202 of the be changed or streamlined to achieve proposed rule. Unfunded Mandates Reform Act of 1995

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(March 22, 1995; Pub. L. 104–4), another agency; (3) materially altering providers and patients will realize Executive Order 13132 on Federalism the budgetary impacts of entitlement throughout this preamble, and (August 4, 1999), the Congressional grants, user fees, or loan programs or the substantial lifesaving benefits. These Review Act (5 U.S.C. 804(2)) and rights and obligations of recipients life-saving effects arise by removing the Executive Order 13771 on Reducing thereof; or (4) raising novel legal or incentives created by the current Regulation and Controlling Regulatory policy issues arising out of legal transplant center regulations to decline Costs (January 30, 2017). mandates, the President’s priorities, or to transplant patients with slightly Executive Orders 12866 and 13563 the principles set forth in the Executive lower probability of success, and to direct agencies to assess all costs and Order. decline to use organs with a slightly benefits of available regulatory A regulatory impact analysis (RIA) lower probability of success. alternatives and, if regulation is must be prepared for major rules with We welcome public comments on all necessary, to select regulatory economically significant effects ($100 of our burden assumptions and approaches that maximize net benefits million or more in any 1 year). We estimates as well as comments (including potential economic, estimate that this rulemaking is identifying additional reforms that environmental, public health and safety ‘‘economically significant’’ as measured should be considered for future effects, distributive impacts, and by the $100 million threshold, and rulemakings. As discussed later in this equity). Section 3(f) of Executive Order hence also a major rule under the regulatory impact analysis, substantial 12866 defines a ‘‘significant regulatory Congressional Review Act. Accordingly, uncertainty surrounds these estimates action’’ as an action that is likely to we have prepared a RIA that, to the best and we especially solicit comments on result in a rule: (1) Having an annual of our ability, presents the costs and either our estimates of likely impacts or effect on the economy of $100 million benefits of the rulemaking. the specific regulatory changes that or more in any 1 year, or adversely and In accordance with the provisions of drive these estimates. materially affecting a sector of the Executive Order 12866, this regulation As stated in the ICR section of this economy, productivity, competition, was reviewed by the Office of proposed rule, we obtained all salary jobs, the environment, public health or Management and Budget. This proposed information from the May 2016 National safety, or state, local or tribal rule would create ongoing cost savings Occupational Employment and Wage governments or communities (also to providers and suppliers in many Estimates, United States by the Bureau referred to as ‘‘economically areas. Other changes we have proposed of Labor Statistics (BLS) at https:// significant’’); (2) creating a serious would clarify existing policy and relieve www.bls.gov/oes/2016/may/oes_nat.htm inconsistency or otherwise interfering some administrative burdens. We have and calculated the added value of 100 with an action taken or planned by identified other kinds of savings that percent for overhead and fringe benefits.

TABLE 12—SECTION–BY–SECTION ECONOMIC IMPACT ESTIMATES

Estimated Number of annual Provider and supplier type and description Frequency affected savings or of proposed provisions entities benefits ($ millions)

Religious Nonmedical Health Care Institutions: • Discharge Planning ...... As patients are discharged (Estimated 619 18 * annual discharges). Ambulatory Surgical Centers: • Governing Body and Management ...... Upon failed hospital transfer agreement at- 5,557 * tempts. • Patient Admission, Assessment and Discharge (History Every patient registration at an ASC or at 5,557 (ASCs) 454 and Physical). a hospital outpatient/ambulatory surgery 5,031 department. (Hospitals) • Medical Records ...... Recurring annually ...... 5,557 0 Hospices: • Drugs and Biologicals, Medical Supplies, and Durable Recurring annually ...... 1,151 80 Medical Equipment. • Hospices That Provide Hospice Care to residents of a Recurring annually ...... 4,602 * SNF/NF or ICF/IID. • Hospice Aide and Homemaker Services ...... Recurring annually ...... 3,498 2 Hospitals: • Quality Assessment and Performance Improvement Pro- Recurring annually ...... 5,031 28 gram. • Medical staff: Autopsies ...... Recurring annually ...... 5,031 0 • Infection Control ...... Recurring annually ...... 5,031 105 • Special requirements for hospital providers of long-term Recurring annually ...... 1,724 30 care services (‘‘swing-beds’’). • Special Requirements for Psychiatric Hospitals ...... Recurring annually ...... 574 62 Transplant programs: • Various provisions related to performance * * ...... Recurring annually ...... 750 Not Quantified Home Health Agencies: • Patient rights ...... Recurring annually ...... 12,624 55 • Home health aide services ...... Recurring annually ...... 12,624 0 • Clinical records ...... Recurring annually ...... 12,624 0 Critical Access Hospitals: • Provision of Services ...... Recurring biennially ...... 1,343 2 • Organizational structure ...... Recurring annually ...... 1,343 *

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TABLE 12—SECTION–BY–SECTION ECONOMIC IMPACT ESTIMATES—Continued

Estimated Number of annual Provider and supplier type and description Frequency affected savings or of proposed provisions entities benefits ($ millions)

• Special requirements for CAH providers of long-term care Recurring annually ...... 1,246 86 services (‘‘swing-beds’’). Comprehensive Outpatient Rehabilitation Facilities: • Utilization Review Plan ...... Recurring annually ...... 188 * Community Mental Health Centers: • Assessment Update ...... Recurring annually ...... 52 * Portable X-Ray Services: • Qualifications of X-ray technicians*** ...... Annual ...... 500 31 • Removing written orders ...... Annual ...... 500 29 RHC (4,160 clinics) & FQHC (7,874 center locations): • Provision of Services ...... Recurring biennially ...... 12,034 7 • Program Evaluation ...... Recurring biennially ...... 12,034 9 Emergency Preparedness for Providers and Suppliers: • Annual Review of Emergency Preparedness Program ...... Recurring annually ...... 72,844 94 • Emergency Plan ...... Recurring annually ...... 68,254 7 • Training and Testing-Training Program ...... Recurring annually ...... 69,196 33 • Training and Testing-Testing ...... Recurring annually ...... 36,971 9

Total Annual Savings ...... 1,123 Life-extending benefits for transplant patients ...... Not Quantified * Amount is less than one million dollars. ** These include proposed changes to the following requirements: Special Requirements for Transplant Programs; Data submission, Clinical Experience, and Outcome Requirement for Re-approval of Transplant Programs; and Special Procedures for Approval and Re-Approval of Organ Transplant Programs. *** This estimate is for first full year savings only and will increase in future years.

C. Anticipated Effects administrative burden associated with point in perspective, emergencies or 1. Effects on Religious Nonmedical preparing an agreement for signature other unforeseen adverse events can Health Care Institutions and going through the hospital arise in any ambulatory medical or credentialing process in order to obtain dental setting, or in home settings. Over As detailed in the Collection of admitting privileges. Currently, all time, ‘‘911’’ emergency calls and direct Information section of this rule, we Medicare-certified ASCs are meeting the ambulance responses have become propose to reduce the discharge transfer agreement or admitting standard operating procedures virtually planning requirements for RNHCIs privileges requirement with the nationwide, regardless of the place in because RNHCIs do not provide medical exception of approximately twenty which the problem arose. Under modern treatment or services. Most patients are ASCs that have tenuous relationships procedures, emergency responders (and discharged to home or to another facility with their local hospital. We estimate patients themselves) take patients to that also does not provide medical the ASCs that do have difficulty with hospital emergency rooms without treatment or services. Although all meeting this requirement would regard to prior agreements between patients must have a discharge planning appreciate the annual burden savings of particular physicians and particular evaluation, not all patients require a 2 to 4 administrator hours spent on hospitals. Indeed, the most appropriate discharge plan. The discharge planning paperwork and documentation. For emergency treatment setting for a cost would be reduced by an estimated those already with the transfer particular patient may not be one $27,013.16. agreements in place, there would not be involving such an agreement even any more follow-up burden related to where the agreement exists. Of course, 2. Effects on Ambulatory Surgical renewals or updates to the documents. nothing prevents particular Centers and Hospital Outpatient/ We estimate the savings at less than arrangements where a hospital and ASC Ambulatory Surgery Departments $10,000 overall and largely believe this agree that this is beneficial for a As of May 2017 there were 5,557 change will not produce significant particular type of surgery or patient Medicare-participating ASCs. We savings, however, it does affect twenty condition and where patient transport proposed to revise the ASC CfCs in or more ASCs in the short term by can be appropriately arranged to reflect order to reduce unnecessary removing the transfer agreement this. Accordingly, we estimate that there duplications and streamline processes requirement. We welcome any feedback will be no consequential adverse health in order to reduce ASC compliance related to the time and effort for those effects of this proposed change, and burden while maintaining minimum ASCs that have secured an agreement, therefore estimate no medical costs. standards for patient safety and care. and if we have underestimated the There will be competitive benefits in The specific savings for each proposed savings of removing this transfer those places where an ASC will now be change are described later in this agreement in the future. As previously allowed to operate and provide care at section of this proposed rule. At discussed, the enactment of EMTALA reduced cost compared to inpatient § 416.41(b)(3), we propose to remove the and its increasingly effective treatment. Nonetheless, we believe that requirements related to transfer enforcement over time has rendered the number of affected areas and agreements and admitting privileges. these transfer and admitting privileges facilities are few, and that annual This change would eliminate the obsolete and unnecessary. To put this benefits are unlikely to reach the

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million dollar range. We welcome personnel spend following up on associated with co-pays and other comments on these effects and on the patient visits to obtain the necessary healthcare cost sharing requirements. preceding analysis of health effects. H&P information and that it will Finally, we believe this change would At § 416.52 we propose to replace the provide for an increase in scheduling reduce expenses for healthcare insurers requirement that every patient must flexibility for the facility. We believe to include Medicare, Medicaid, and have a comprehensive H&P within 30 these changes may have the effect of private healthcare insurance companies. days prior to surgery in an ASC with a improving patient satisfaction and requirement that allows the operating increasing positive patient referrals for This change would reduce costs physician and ASC to determine which the ASC. associated with reduced pre-operative patients would require more extensive For community-based healthcare exams, laboratory testing, chest testing and assessment prior to surgery. providers, to include primary care radiographs, and echocardiograms. We believe that this change would providers, we believe this change would It is difficult to estimate the savings reduce patient and provider burden in reduce unnecessary examinations that from this change, because they depend a multitude of ways that includes the are required to be performed and reduce on a number of factors previously community-based physician, the ASC, administrative paperwork burden described, and additional factors for and the patient. We believe that in associated with providing ASCs with which we do not have precise measures, almost all situations ASCs can the necessary H&P documentation and such as the number of patients (both reasonably rely on existing H&P results additional testing requirements. This Medicare and non-Medicare) who that are more than 30 days old and then change may potentially provide an received two or more ASC services are updated by patient responses on the opportunity for increased access to within the 30-day window allowed for day of surgery, but we cannot forecast community-based providers because of one physical examination. This is a with any precision what medical available appointments that are not common occurrence because, for specialty societies, ASC governing being filled by unnecessary patient bodies, hospital governing bodies, or appointments for H&P requirements for example, patients often receive cataract accreditation bodies will decide to do in surgery in an ASC. Those vacant surgery on one eye and then, a week replacing the current requirement. appointments may also generate more later, on the other eye. Furthermore, Therefore, we do not forecast specific revenue. there are an immense number of cost savings at this time, and solicit For patients, we believe this change different outpatient surgical services. At public comments to help us with our would reduce the time spent to prepare present, for example, there are about estimate in the final rule. for surgery (time in community-based 137 services that account for about 90 For ASCs, we believe this change physician office, travel time and costs, percent of ASC volume, and these would reduce administrative burden by time missed from the work place and services are highly diverse, as shown in decreasing the amount of time that ASC lost productivity) and the cost Table 13.

TABLE 13—TWENTY MOST FREQUENT ASC SERVICES IN 2015

Percent of Surgical service Rank volume

Cataract surgery w/IOL insert ...... 1 18.60 Upper GI endoscopy, biopsy ...... 2 8.2 Colonoscopy and biopsy ...... 3 6.8 Lesion removal colonoscopy (snare technique) ...... 4 5.6 Inject foramen epidural: Lumbar, sacral ...... 7 4.8 After cataract laser surgery ...... 6 4.4 Injection spine: Lumbar, sacral (caudal) ...... 8 3.3 Inject paravertebral: Lumbar, sacral ...... 9 3.1 Diagnostic colonoscopy ...... 5 2.3 Colorectal screen, high-risk individual ...... 10 2.0 Colorectal screen, not high-risk individual ...... 12 1.9 Cataract surgery, complex ...... 11 1.6 Injection procedure for sacroiliac joint, anesthetic ...... 19 1.3 Cystoscopy ...... 15 1.2 Upper GI endoscopy, diagnosis ...... 13 1.0 Inject spine, cervical or thoracic ...... 17 1.0 Revision of upper eyelid ...... 16 0.9 Lesion removal colonoscopy (hot biopsy forceps) ...... 14 0.8 Upper GI endoscopy, insertion of guide wire ...... 18 0.8 Carpal tunnel surgery ...... 20 0.7

Total ...... 70.4 Source: MEDPAC. Ambulatory surgical center services. 2017, p. 140.

In total, ASCs provided about 6.4 another H&P with its associated battery would then require a new H&P and tests million services in 2015 (MEDPAC. of tests were required for each of the before surgery under the current Ambulatory surgical centers services, remaining 4.8 million individuals. requirements. In the great majority of 2017, p. 139). If we assume that 25 Assuming that 5 percent of these would cases involving eye or eyelid surgery of percent of these had two or more otherwise have already had an overall one kind or another, the ophthalmology services within the 30-day ‘‘window’’ H&P and associated tests within 30 days examination preceding the ASC surgery allowed in the current rule, then of the surgery, 4.56 million persons would not have involved a

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comprehensive H&P or battery of tests, requirement existed. Of course, it is percent of ambulatory plastic surgeries. and a similar situation would be unlikely that in such cases a strict 30- This leaves an upper bound of 33 to 38 involved for most other surgeries day window would be insisted on. percent of non-cataract outpatient preceded by specialist rather than Assuming that such examination and surgery H&P costs that could reasonably primary care visits. testing information would continue to be expected to be avoided as a result of Although we are unable to estimate be needed for 10 percent of all patients, this rulemaking. In order to more the likely number of cases, one way to and that in half of these cases the successfully tailor the upper bound of estimate the costs of these examinations information would require a new potential cost savings to H&P activity— and tests would be as follows. First, the examination and tests within a 30-day rather than just extrapolating from H&P itself would cost approximately window, the net costs of the current testing behavior—we request comment $100 (the exact amount depending on regulatory requirement would be 5 on the possibility of building on Chen diagnostic details, and not necessarily percent less than the preceding et al.’s data and methodology to corresponding to any particular calculations. Supposing that such estimate the increased frequency of payment schedule). The battery of tests examination and testing information within-30-day office visits (presumed to would cost approximately $100, would still be required for 50 percent of be H&P) when ophthalmologist visits assuming both urine and blood testing, all patients, the costs of the current are at least 31 days prior to surgery and, in some cases, an requirement and hence the potential relative to when ophthalmologist visits electrocardiogram, but only half of savings from its reform would fall much are no more than 30 days prior. physical examinations (for example, few further. Absent more specific As noted in the medical literature or no ophthalmologist exams) would information, the estimates of potential previously discussed, Chung F, Yuan H, include such tests. The travel of the costs and savings in Table 14 are Yin L, Vairavanathan S, and Wong DT. patient to and from the physician office suggestive but not robust until or unless Elimination of preoperative testing in to obtain the examination and tests improved through public comment and ambulatory surgery. Anesth Analg. 2009 would on average require 1 hour, which additional information. In our summary Feb, 108(s):467–75, there are no known when valued at the average wage rate in estimates, we have assumed a range of consequential medical benefits from the the economy of $24 (increased by 50 savings from zero to 50 percent, with a testing often performed in association percent to include fringe benefits but midpoint of 25 percent. with the current regulatory not overhead) would cost about $36. In As support for the 50 percent upper requirements. This study covered hernia addition, ASCs incur substantial costs bound, we note that Chen CL, Lin GA, patients but similar results have been for the time and trouble needed to found in studies of cataract surgery. contact physician offices and arrange for Bardach NS, Clay TH, Boscardin WJ, Accordingly, eliminating the testing the results to be delivered. The Gelb AW, Maze M, Gropper MA and could in theory produce very substantial physician offices themselves would be Dudley RA, Preoperative Medical annual ASC cost savings with no put through the trouble of transferring Testing in Medicare Patients offsetting medical cost increases or those medical records. Assuming Undergoing Cataract Surgery, New harm to patients. H&P itself, however, is average time spent (the median would England Journal of Medicine 372:1530– distinct from testing, and literature be less but a small number of difficult 1538, April 16, 2015, find that indicating that testing is wasteful does cases would bring the average well approximately 53 percent of Medicare not necessarily speak to the importance above the median) would reach 10 cataract patients undergo pre-operative of H&P. Therefore, if H&P is avoided, minutes, and the use of a general office testing, none of which is mandated by clerk at $32 an hour, the cost per patient CMS regulation. If these patients’ rather than more thoroughly integrated would average $5 per patient. A further physicians are cautious enough to into same-day presurgical assessments, cost arises because in many cases the currently pursue more preoperative there could be adverse consequences to examination and test results simply activity (testing, H&P, etc.) than what is patients; these impacts have not been cannot be obtained timely, and a required, or state or hospital rules are quantified. scheduled surgery has to be postponed. driving physician behavior beyond what As discussed in ‘‘Provisions of the Assuming that in such cases a half hour Medicare necessitates, then there is Proposed Regulations,’’ section II.D. 2. of surgeon time (at $243 an hour) and little reason to believe that that behavior of this proposed rule, there is a similar a half hour of registered nurse (RN) time will change with the finalization of this regulatory requirement for hospital (at $69 an hour) is wasted, and that rule. Given that other procedures tend outpatient surgery. Based on the clerical time ($32 an hour) to reschedule to be more invasive than cataract substantial similarity between these two averages 10 minutes, the average cost surgery, pre-operative caution on the service settings, we also propose to per postponement would be $161. (In part of physicians is likely to be even eliminate these requirements for such some of these cases patient time would greater in the non-cataract context. surgery. Although we do not have be wasted, as well as the time of family Indeed, Benarroch-Gampel J, Sheffield detailed data for hospital outpatient members accompanying the patient—we KM, Duncan CB, Brown KM, Han Y, surgery, it is widely agree to be roughly have not estimated these costs.) Townsend CM and Riall TS, equal in size and composition to ASC Aggregating these calculations, one Preoperative Laboratory Testing in surgery, though spending is higher estimate of the annual costs of the Patients Undergoing Elective, Low-Risk because a higher payment schedule is current regulatory requirement, as Ambulatory Surgery, Annals of Surgery used by some insurers, including shown in Table 14, could be as much as 256(3):518–528, September 2012, and Medicare, for most hospital outpatient $972 million for ASCs and a similar Fischer JP, Shang EK, Nelson JA, Wu surgery. Regardless, estimates should be amount for hospital outpatient surgery. LC, Serletti JM and Kovach SJ, Patterns based on economic costs, not any For many and perhaps most cases, of Preoperative Laboratory Testing in particular payment schedules. however, either the surgeon or the Patients Undergoing Plastic Surgery Accordingly, potential total annual facility would decide that H&P Procedures, Aesthetic Surgery Journal savings, and hence benefits, for both information is needed for particular 1(1):133–141, January 2014, find that settings taken together could be as much patients or particular procedures almost two-thirds of hernia procedures as $1.7 billion. This would depend on whether or not this regulatory are preceded by testing, as are 62 whether hospital-based outpatient

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surgery decisions parallel those of literature shows that we can be to present a predetermined figure in this independent ASCs. reasonably certain that for some proposed rule. Instead, we are If, after ASCs and hospitals make procedures, such as cataract surgery, requesting public comments on all the policy decisions on which types of few or possibly even no costs would be parameters of our estimates to inform outpatient/ambulatory surgery patients self-imposed, there may be other the estimates we will make in the final would require a comprehensive H&P, it procedures where ensuing policy rule. We welcome information on likely is found that only 50 percent of current decisions would retain all current decisions in both ASC and hospital costs were continued, potential total history and physical requirements, outpatient settings, and if possible for annual savings, and hence benefits, for though likely removing the strict 30-day the most common procedures shown in both settings taken together could be as rule. Because of the proposed Table 13 and for the likelihood and cost much as $908 million, assuming that hospital-based outpatient surgery H&P requirements, and other uncertainties, saving effects for procedure and patient policy decisions parallel those of the potential savings from lifting the categories where the facility chooses to independent ASCs. Alternatively, if 75 current requirements encompass at least retain an external H&P requirement, but percent of current costs were continued, this broad range and quite possibly extends the time window to a year or potential savings would be only about more. Because there is great uncertainty some other period that is far longer than $454 million annually. While the in these estimates we have decided not 30 days.

TABLE 14—CURRENT COSTS AND POTENTIAL ANNUAL SAVINGS FROM CREATING AND OBTAINING EXAMINATION AND TEST RESULTS

Twenty-five Seventy-five Number Current percent Fifty percent percent Type of cost Unit cost (M) total cost retained retained retained ($M) ($M) ($M) ($M)

Physical Examinations ...... $100 4.56 $456 $114 $228 $342 Test Batteries ...... 100 2.28 228 57 114 171 Patient Travel Cost ...... 36 4.56 164 41 82 123 Administrative Cost to ASC ...... 5 4.56 23 6 11 17 Surgery Cancellations * ...... 161 0.228 37 9 18 28

Total Cost, ASCs ...... 908 227 454 681 Total Cost, Hospital Outpatient ** ...... 908 227 454 681

Total Cost ...... 1,815 454 908 1,362

Total Savings ...... 1,362 908 454 * Based on information from a major ambulatory surgery facility, this estimate assumes that 5 percent of scheduled cataract operations are cancelled at the last minute since the required H&P information has not arrived from the physician office where the examination was performed and the tests ordered or performed. Staff salaries must still be paid. Our estimates assume one half hour of surgeon time wasted (at $243 an hour), one half hour of RN time wasted (at $69 an hour), and ten minutes of clerical time (at $32 an hour) to reschedule. ** Hospital outpatient savings assumed to be equal to ASC savings.

We assume that the one-time costs of exempting ASCs, but not hospital burden while maintaining minimum developing such policies for hospital outpatient departments, changing the standards for patient safety and care. outpatient surgery in 5,031 Medicare- 30-day requirement to something much At § 418.76(a) we propose to defer to participating hospitals would be the longer in duration such as 6 months or State training and competency same in the aggregate, though the mix of a year, and likely others. Absent requirements, where they exist, for personnel used would be somewhat contrary evidence, however, we believe hospice aides. Deferring to state different and the cost at free-standing that relying on physician and facility requirements would streamline the hospitals would likely be several times judgment maximizes benefits and hiring process because hospices would higher (for example, for involvement of presents no consequential costs. not have to verify that a job candidate’s the governing body and legal review). qualifications meet or exceed the We welcome comments on these About 3,200 of these hospitals are in Federal standard in addition to verifying estimates and on both the proposal and multi-hospital systems that would, that the candidate meets State however, reap economies of scale, and any alternatives, and particularly requirements. welcome any evidence-based about 574 are psychiatric hospitals that According to the BLS, 408,920 aides information that would inform both our we assume rarely perform surgery. In are currently employed in ‘‘home care’’. ability to provide cost savings estimates total, we estimate that, first year savings The term ‘‘home care’’ encompasses and a policy choice between either the for both types of facilities would be $38 both home health agency and hospice million less, regardless of the proposed reform or an alternative. employers. There are 12,624 HHAs and replacement rules that each facility 3. Effects on Hospices 4,602 hospices, meaning that hospices imposed on itself. represent 27 percent of the ‘‘home care’’ There are possible alternatives, As of May 2017 there are 4,602 employer market. Thus, we conclude including limiting the regulatory reform Medicare participating hospices. We that hospices employ 110,408 aides (27 to the lowest risk procedures, which proposed to revise the hospice CoPs in percent of all aide positions in ‘‘home would probably mean almost all order to reduce unnecessary care’’). Based on an informal survey procedures, excluding certain duplications and streamline processes conducted by the largest hospice procedures from the regulatory reform, in order to reduce hospice compliance industry association, 76 percent of

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States have their own training and overall group discussion time, new, more easily understandable competency requirements, accounting particularly for the 3 members of the materials for patient education, we for approximately 83,910 aide positions. interdisciplinary group that are not believe that hospices would realize a Hospices in these states would benefit charged with being the pharmacology savings of 10 minutes per patient from the proposed change because they expert. Based on 1.6 million hospice because it would require less hospice would be permitted to rely on the patients and an assumed 3 staff time to explain the more completion of state mandated training interdisciplinary group meetings per understandable material. Based on an and competency programs to assure that patient, there are a total of 4,800,000 assumed 10 minutes of saved nursing a candidate is qualified for employment, interdisciplinary group meetings per time per patient, and 1.6 million and would no longer have to take the year. We assume that each patients, hospices would save 266,667 additional step of verifying that each interdisciplinary group meeting hours. At a cost of $69 per hour, the potential job candidate also meet the includes 2 minutes of time specifically total savings would be $18,400,023. Federal requirements. We assume a 25 related to discussing the results of the First year: $18,400,023 percent turnover rate based on pharmacy advisement service for savings¥$483,210 initial year cost = discussions with industry experts, or purposes of complying with the $17,916,813 net savings. 20,978 aide job listings per year. Based regulation, or 160,000 hours per year Annually thereafter: $18,400,023 on an assumed 20 candidates that nationwide. At a cost of $299 per hour savings. would require the qualifications ($198 physician + $53 social worker + At § 418.112(f) we propose to allow verification per job listing, we estimate $48 pastoral counselor), we estimate hospices and long term care facilities that hospices must verify the training that removing this requirement would the additional flexibility to negotiate the and competency program content and save $47,840,000 annually. format and schedule for orienting long Additionally, we believe that this format for 419,560 candidates per year. term care facility staff regarding certain change would reduce the specialist We assume that it would take 10 hospice-specific information. We nursing time spent specifically on minutes per candidate to verify believe that this would allow for advisement services. We believe that compliance with the Federal innovation and streamlining, and moving away from a regulatory requirements, for a total of 69,927 hours reduce hospice compliance costs related compliance ‘‘check box’’ approach per year nationwide. At a cost of $32 per to this requirement by 20 percent. For would allow the specialist nurse to hour for a general office clerk to perform purposes of our analysis only, we incorporate medication management this check, we estimate that hospices assume that a typical hospice conducts more seamlessly into regular clinical will save $2,237,664 annually. 6 orientation sessions per year, and that practice. The 2008 Hospice CoP final At § 418.106(a) we propose to delete rule (73 FR 32088) estimated a 1 hour each orientation requires 2 hours of time the requirement that a hospice must burden per patient for expert pharmacy from a hospice nurse. At a cost of $69 ensure that the interdisciplinary group services (30 minute initial advisement per hour, a typical hospice would spend confers with an individual with per patient + 2 15 minute update $828 each year to orient long term care education and training in drug advisements) for a total cost of $69 per facility staff. Assuming a 20 percent management as defined in hospice patient for all advisement services reduction in burden that can be policies and procedures and State law, (updated to 2017 dollars). We estimate achieved through innovation and who is an employee of or under contract that this proposed change would reduce streamlining, a typical hospice would with the hospice to ensure that drugs that time by 50 percent, to 30 minutes save $166 a year, or $763,932 savings and biologicals meet each patient’s per patient, resulting in a $35 per annually for all 4,602 hospices. needs. Not requiring the specific patient savings. Based on the Taken together, these proposed pharmacy advisement function would assumption that 25 percent of hospices reforms would generate annual savings allow for more streamlined use their own employee to perform this of approximately $82.8 million ($47.8 interdisciplinary group meetings. We function, we estimate that this reduction million for reduced interdisciplinary assume that 25 percent of hospices would occur for 400,000 patients group meeting time + $14 million for currently use their own staff (employee nationwide (25 percent of 1.6 million reduced specialty nursing time + $18 or contract) for this function, and that hospice patients), for a total annual million for streamlined controlled drug this staff member is typically the nurse savings of $14,000,000. education practices + $2.2 million for member of the interdisciplinary group. Together with the previously stated streamlined hospice aide qualification The nurse member of the estimate, total savings would be requirements + $0.8 million for interdisciplinary group is also required $47,840,000 + $14 million = streamlined facility staff orientation). by § 418.56(a); therefore we believe that $61,840,000 annually. We welcome public comment regarding removing this requirement will not We propose to revise the requirement these burden estimates, and additional result in removing the expertise from at § 418.106(d) to allow hospices to regulatory reforms to reduce the burden the group. Rather, we believe that provide information regarding safe of the hospice CoPs. removing this requirement will remove medication use, storage, and disposal in 4. Effects on Hospitals the formulaic approach to a more understandable manner. Under interdisciplinary discussions whereby the current requirements, hospices are As of May 2017, there were 5,031 the group allots time in each meeting required to provide patients and Medicare participating hospitals. We specifically for this discussion in order families with a copy of the hospice’s propose to revise the hospital CoPs in to assure regulatory compliance. In the policies and procedures, which are not order to simplify some requirements absence of regulation, the written in layperson terms. The and streamline processes in order to interdisciplinary group would have the proposed change would alleviate the reduce burden associated with hospital authority to decide whether the burden associated with addressing the compliance with the Medicare CoPs discussion is pertinent for a given confusion created by the policies and while maintaining minimum health and patient and the information can be procedures document. Following the safety standards. The specific savings woven into the discussion at large. This initial cost of $483,210 (described in for each proposed change are described approach has the potential to reduce the section III.E. of this rule) for developing below.

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At § 482.21, we propose to allow for (2,255 × $10,000), for an annual total estimation. At §§ 482.58(b)(1) and multi-hospital systems using a system savings of approximately $28 million. 485.645(d)(1) (cross-referenced long- governing body, as allowed under the We welcome comments on the term care requirement at § 483.10(f)(9)) CoPs, and that is legally responsible for quantitative and non-quantitative we propose to remove the requirement two or more separately certified member portions of the preceding discussion for hospital and CAH swing-bed hospitals, to have a unified QAPI and seek any empirical evidence that providers to provide the right for program for the member hospitals would improve the accuracy and patients to choose to or refuse to subject to the system governing body. thoroughness of the relevant benefits perform services for the facility and if This will afford hospitals flexibility and estimation. they so choose, (a) document in the the ability to gain efficiencies and We propose to remove the resident’s plan of care, (b) noting achieve significant progress in quality requirement for hospitals at § 482.22(d), whether the services are voluntary or by sharing best practices among all which states that a hospital’s medical paid and (c) provide wages for the work hospitals subject to the system staff should attempt to secure autopsies being performed given the location governing body. This would be similar in all cases of unusual deaths and of quality, and quantity of work requiring to current allowances for system medical-legal and educational interest. comparable skills. We discuss the governing bodies and unified medical Because this requirement is redundant economic impact for this provision in staffs. and more detailed, specific the ICR section of this rule, which is While there are no current requirements regarding medical-legal estimated to be $32 million. requirements that explicitly prohibit the investigative autopsies are required by sharing of best practices across a system, individual state law, we do not At § 482.58(b)(4) (and § 485.645(d)(4)) the current requirements for each anticipate that hospitals would accrue (cross-referenced long-term care hospital to have its own separate and additional savings from this change. The requirement at § 483.24(c)), we propose distinct QAPI program and Infection benefit to hospitals from eliminating to remove the requirement for hospital Control program certainly have this requirement is realized through a and CAH swing-bed providers to inhibited and stifled sharing of best reduction in burden from no longer provide an ongoing activity program practices and innovations among having to comply with two similar that is directed by a qualified individual hospitals within a system as requirements of the Federal government therapeutic recreation specialist or an we point out in the preamble to this and the State government. Hospitals activities professional who meets proposed rule, and which we support would instead be required to follow the certain requirements as listed at with our reference to the Health more detailed, specific regulations of § 483.24(c)(2). We discuss the economic Research and Educational Trust, in the state in which they are located. impact for this provision in the ICR partnership with the American Hospital At § 482.42, we propose to allow for section of this rule, which is estimated Association March 2010 publication multi-hospital systems using a system to be $81 million. entitled, ‘‘A Guide to Achieving High governing body as currently allowed We propose to remove the Performance in Multi-Hospital Health under the CoPs, and that is legally requirement at §§ 482.58(b)(5) and Systems.’’ This publication, along with responsible for two or more separately 485.645(d)(5) (cross-referenced long- positive public comments regarding certified member hospitals, to have a term care requirement at § 483.70(p)) for unified medical staffs that we discussed unified infection control program for hospital and CAH swing-bed providers in the May 2014 final rule and to which those member hospitals subject to the to employ a qualified social worker on we refer in this proposed rule, clearly system governing body. This would a full-time basis if the facility has more point to multi-hospitals more efficiently allow hospitals flexibility and the than 120 beds. Given that this provision and effectively collecting, ability to gain efficiencies and achieve is not applicable to either provider type disseminating, and sharing innovations, significant progress in infection due to the regulatory requirements for solutions, and best practices for patient prevention and control. This would also each, it does not impose a burden upon care to each of its member hospitals be similar to current allowances for hospitals and as such, its removal through these unified patient care system governing bodies and unified would not result in a savings of burden programs. medical staffs. hours or dollars. Approximately 3,200 of the 5,031 The current regulatory burden for At §§ 482.58(b)(8) and 485.645(d)(8) Medicare-participating hospitals compliance with the Infection Control (cross-referenced long-term care participate in a hospital system program requirement is approximately requirement at § 483.55(a)(1)) we (American Hospital Association (AHA), $191 million annually for all hospitals propose to remove the requirement for Fast Facts 2017 (https://www.aha.org/ or $38,000 per hospital. If we were to system/files/2018-01/fast-facts-us- allow a unified Infection Control hospital and CAH swing-bed providers hospitals-2017_0.pdf)). According to the program for multi-hospital systems, this to assist in obtaining routine and 24- 2017 AHA Guide, there are 424 multi- would remove 3,200 hospitals from the hour emergency dental care to its hospital systems. The current regulatory total 5,031 (replaced by the 424 multi- residents. We discuss the economic burden for compliance with the QAPI hospital systems) for a total of 2,255 impact for this provision in the ICR program requirement is approximately hospitals/multi-hospital systems that section of this rule, which is estimated $10,000 annually per hospital or $50.3 would still need to comply. The new to be $2.9 million for all hospital and million annually for all 5,031 hospitals. regulatory burden would be a total of CAH swing-bed providers. If we were to allow a unified QAPI approximately $86 million annually At § 482.61(d), we propose to allow program for multi-hospital systems, this (2,255 × $38,000), for an annual total non-physician practitioners to would remove 3,200 hospitals from the savings of approximately $105 million. document progress notes in accordance total 5,031 (replaced by the 424 multi- We welcome comments on the with State laws and scope of practice hospital systems) for a total of 2,255 quantitative and non-quantitative requirements. We discuss the economic hospitals/multi-hospital systems that portions of the preceding discussion impact for this provision in the ICR would still need to comply. The new and seek any empirical evidence that section, which is estimated at $54.7 regulatory burden would be a total of would improve the accuracy and million in savings for psychiatric approximately $22.6 million annually thoroughness of the relevant benefits hospitals.

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5. Effects on Transplant Programs and all kidney failure patients, regardless of United States,’’ American Journal of Patients age, and these patients receive costly Transplantation, Volume 16, Issue 12, There are approximately 750 dialysis for a prolonged period of time. December 2016, pages 3371–3377; Medicare approved transplant programs As is the case for all CoPs, our Howard R, Cornell D, and Schold J, in the United States, of which 250 are regulations for Medicare-approved ‘‘CMS Oversight, OPOs and transplant kidney transplant programs. All organ transplant programs have the centers and the law of unintended Medicare approved transplant programs potential to protect all patients, not just consequences, Clinical Transplantation, must be a part of a Medicare approved Medicare beneficiaries. Volume 23, Issue 6, November/ hospital, and many hospitals have As discussed earlier in this preamble, December 2009, pages 778–783; and several types of organ programs. we have long regulated transplant Abecassis M, Burke R, Klintmaim G, programs, but put in place additional Oversight of these programs occurs in Matas A, Merion R, Millman D, Olhoff CoPs in the March 2007 final rule (72 two major ways: By the Organ K, and Roberts J, ‘‘American Society of FR 15198) in an effort to increase the Procurement and Transplantation Transplant Surgeons Transplant Center quality of care by specifying minimal Network (OPTN), which is a non-profit Outcome Requirements—A Threat to health and safety standards. In addition, membership-based organization Innovation,’’ American Journal of outcome metrics (1 year graft and operated under a Federal contract Transplantation, Volume 9, Issue 6, patient survival) were included in the administered by the Health Resources June 2009, pages 1279–1286; and regulation and mirrored the OPTN and Services Administration (HRSA), Schold J, Miller C, Mitchell H, Buccine outcomes metrics as calculated by the and by CMS under the CoPs. The L, Flechner S, Goldfarb D, Poggio E, and SRTR. Over time, increased emphasis current and long-term OPTN contractor Andreoni K, ‘‘Evaluation of Flagging on organ and patient survival rates, as Criteria of United States Kidney is the United Network for Organ Sharing key metrics of transplant performance, (UNOS), which performs many Transplant Performance: How to Best created incentives for transplant Define Outliers,’’ Transplantation, June transplantation functions, including programs to select organs most likely to matching donated organs to waiting lists 2017, Volume 101, Issue 6, pages 1373– survive after transplant without 1380. These studies regarding the of patients who have failing organs, and rejection, and to select recipients most reviewing the performance of transplant reduced number of transplants that likely to survive after the transplant. In would otherwise have occurred, yielded centers on a variety of criteria, including particular, due to the increasing patient patient and organ survival. There is a several relevant facts. The number of and organ survival rates over time, the deceased donor organs that are third mechanism encouraging better 2007 standards have become transplant program performance, the discarded has been increasing over time increasingly stringent over time as an and for kidneys, is above 20 percent. For SRTR (accessed at https://www.srtr.org). artifact of the performance calculation The SRTR, also operated under a HRSA example, about 33 percent of kidneys method established in the 2007 rule, an recovered from donors age 50 to 64 are contract, provides detailed data on the outcome that was never intended by performance of all transplant programs, discarded, as are about 62 percent of CMS. In addition, the 2007 rule created kidneys recovered from donors age 65 or and allows the OPTN, individual performance standards that focused transplant programs, and patients older (Hart A. et al., OPTN/SRTR 2015 only on organ and patient survival rates ‘‘Annual Data Report: Kidney.’’ themselves to compare results on such for those who received a transplant, not vital metrics as patient survival rates Accessed at http:// on survival rates of patients awaiting onlinelibrary.wiley.com/doi/10.1111/ after transplant. transplant. We refer readers to a ajt.14124/full). Officials of the UNOS For patients with most types of organ discussion of this problem in the have stated at public meetings that in failure, a transplant is the only option following CMS compliance Guidelines their judgment up to 1,000 kidneys of for long-term survival. In the case of that could only partially lighten this the approximately 3,000 that are kidney failure, however, kidney dialysis unintended regulatory burden at https:// discarded each year are of good enough is a viable medium-term and sometimes www.cms.gov/Medicare/Provider- quality to be transplanted successfully. long-term option for most patients. On Enrollment-and-Certification/Survey The number of organ transplantations average these patients can survive a CertificationGenInfo/Downloads/ reached record highs in 2016 (33,500), dozen or more years on dialysis; Survey-and-Cert-Letter-16-24.pdf. however, without a transplant, they There is extensive literature on these about 20 percent more than 5 years suffer increasingly high morbidity and incentives and other phenomena in earlier, due mainly to increased mortality rates. We provide Medicare transplant medicine that strongly donation rates (OPTN, ‘‘United States coverage for such patients through the suggests some unintended consequences organ transplants and deceased donors ESRD program. Under the ESRD on organ utilization (decreased use of set new records in 2016.’’ Accessed at program, patients receive dialysis ‘‘marginal’’ organs in their patients) and https://optn.transplant.hrsa.gov/news/ treatment, usually three times a week, de-selection of some patients who are us-organ-transplants-and-deceased- through machines that cleanse their slightly less likely to survive for an donors-set-new-records-in-2016/). blood in much the same way as healthy extended period post-transplant. These For purposes of this analysis, one kidneys would do. Since its inception in unintended consequences have been approach to estimating effects is to 1973, more than one million patients anecdotal and measuring the extent to isolate the number of kidneys (and other have received treatment under this which they have occurred is difficult. In organs) that have been discarded as a program. Kidney failure patients are addition to the studies previously cited result of the March 2007 rule; indeed, a unique in another way: Unlike most in the preamble (Adler et al., Schold et reasonable assumption would be that other organs, with the partial exception al., Dolgin et al., Stewart et al., Husain this proposed rule’s rescission of the of some liver donations, it is possible for et al.), other studies on this issue 2007 requirements would have an equal living individuals to donate ‘‘live’’ include Kasiske B, Salkowski N, Wey A, and opposite effect. A slide presentation kidneys, whether the living donor is a Israni A, and Snyder J, ‘‘Potential by UNOS researcher Darren Stewart relative or an unrelated altruistic donor. Implications of Recent and Proposed (2017; accessed at https:// In the case of ESRD patients, the Changes in the Regulatory Oversight of www.myast.org/sites/default/files/ Medicare ESRD program serves almost Solid Organ Transplantation in the ceot2017/AST%20CEOT%2001%20

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Stewart%20-%20No%20Organ%20 provide a baseline, these studies make of Participation for Transplant Left%20Behind%20-%20S3.pdf), the conservative assumption that those Programs,’’ Health Services Research, presents an estimate that about 1,110 of programs with zero sanctions have not April 2015, 330–350). White et al.’s about 2,759 kidneys discarded in 2012 removed any patients from their finding of reduced transplant volumes were of transplant quality and that transplant waiting list in order to avoid at particular kidney transplant centers between 500 and 1,000 of these could sanctions. For kidneys, one study does not necessarily indicate decreased have been used in transplants (the most estimated that in the seven year period transplant volumes overall, with the recent discard numbers, for 2016, are from 2007 to 2014, the lower performing authors stating that their aggregate about 20 percent higher than in 2012 programs removed from waiting lists results ‘‘do not indicate that the and one-third higher than in 2007). This over 2500 patients more than would introduction of the [2007] CoPs has presentation cites the study previously have been expected absent sanctions, an systematically reduced opportunities for discussed in this preamble (Stewart et average of over 350 per year (J.D. Schold marginal candidates or that there has al. (2017)), that shows kidney discard et al., ‘‘Association of Candidate been a systematic shift away from rates rising from between 5 and 7 Removals From the Kidney Transplant utilization of higher risk deceased donor percent in the late 1980s to 19.2 percent Waiting List and Center Performance kidneys.’’ In other words, regulatory in 2015. Notably, the discard rate had Oversight,’’ American Journal of sanctions could have triggered already reached approximately 18 Transplantation 2016, 1276–1284). The behavioral responses by some patients, percent by 2007, making the rate of implications, for the present time, of some transplant surgeons, or some increase much lower after the March wait list changes initiated in 2007 is health insurance plans to shift patients 2007 rule was implemented than it had unclear. Increased mortality in 2007 away from these centers (many insurers been in the previous two decades. among the very sick patients who were restrict coverage through ‘‘centers of Although this contrary evidence is far dropped from the wait list would have excellence’’ programs). Schold et al. from definitive, it suggests that the freed up organs for 2007’s moderately (2013) find additional support for this effect of the March 2007 rule was too sick patients; these patients otherwise phenomenon, describing their empirical small to be observable in the kidney would have declined in health so as to result as follows: ‘‘Among 203 [adult discard data. be the very sick population in 2008. kidney transplant] centers, 46 (23%) Unfortunately, these and other studies Thus the absolute level of health in were low performing (LP) . . . Among have had to deal with other trends 2008 would have been relatively good, LP centers, there was a mean decline in during the last two decades that greatly in which case the phenomenon of transplant volume of 22.4 cases complicate measuring the independent patients being dropped from the wait compared to a mean increase of 7.8 effect of the 2007 rule. These include list might not have perpetuated into the transplants among other centers.’’ The the increasing age of the donor pool and future, leaving little or no scope for estimated decrease per low-performing the attendant decline in some benefits to be achieved now as a result transplant center is roughly three times dimensions of organ quality, and the of the proposed CoP revision. (We note the increase per other center, but there opposite effects of improved techniques that one year, from 2007 to 2008, may are also roughly three times as many for maintaining organ quality between be an exaggeration as to the short-term other centers as low-performing centers; the time of donation and the time of nature of this wait list-related effect, but as such, the most straightforward transplantion. As a result, the published a somewhat longer tapering period interpretation of this paper is that the studies using data on organ discards could still have reached completion same number of transplants is being have had to use complicated now, more than a decade after the concentrated in a smaller number of multivariate statistical procedures in implementation of the 2007 CoP, thus transplant centers. This outcome could attempting to estimate the effects of the leaving little scope for benefits.) On the still have real impacts, such as changes 2007 rule, and invariably conclude that other hand, if the sickest patients in in travel time for patients, but although their findings are subject to considerable 2008 were dropped based on their these impacts are valid for inclusion in uncertainty. The preceding analysis focuses on relative health levels—in spite of their a regulatory impact assessment, they discard rates as a tool that transplant improved absolute health relative to the would be much smaller in magnitude programs can use to reduce risk of lower sickest patients in 2007—there would be than the longevity benefits emphasized patient or organ survival rates, and potential wait list-related benefits from elsewhere in this analysis. hence risk of closure under the 2007 revising this CoP at the present time. A feature common to most of these rule. A second tool that a transplant The benefits of shifting transplants to studies that is that they use data that are program can use to reduce its risk of the sickest patients from relatively less already several years old when the lower overall patient survival rates is to sick patients have not been quantified, study is published, both because of the remove patients who are slightly less but because the harm to the less sick usual publishing lag and because likely to survive from its waiting list, patients would need to be netted off the performance data such as one-year most commonly by making a judgmental benefit to the sickest patients, the per- survival rates necessarily make decision that the patient is ‘‘too sick for transplant magnitude would be much transplant program results less timely. transplantation.’’ Programs that are on lower than the per-transplant benefits of None of these studies covers the last two the margin of receiving regulatory avoided organ discards. or three years of transplant program sanctions, or that have received such Another quantitative study of kidney performance. As a result, none of these sanctions already, are particularly likely transplant effects used a similar studies has been able to use actual data to exercise such judgments to reduce methodology and estimated that as a to assess the effects of the May 13, 2016 regulatory risk. Several studies have result of the 2007 rule, in 2011 CMS changes that slightly reduced the estimated specific numbers of transplant sanctioned programs performed 766 performance level for finding a reductions due to the 2007 rule by fewer kidney transplants than would ‘‘condition-level’’ violation that comparing the number of patients otherwise have been the case (Sarah L. threaten’s program closure. For recent removed from the waiting list at White et al., ‘‘Patient Selection and reviews of potential effects of those programs that have received regulatory Volume in the Era Surrounding changes see B.L. Kasiske et al., sanctions to those that have not. To Implementation of Medicare Conditions ‘‘Potential Implications of Recent and

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Proposed Changes in the Regulatory uncertainties involved, make a precise transplant recipients compared to those Oversight of Solid Organ as well as reliable estimate all but remaining on dialysis. The Annual Data Transplantation in the United States,’’ impossible and would render arbitrary Report of the United States Renal Data Am J Transplant, December 2016, any non-zero lower bound estimate of System utilizes national data on ESRD, 16(12), 3371–3377, and Colleen Jay and health and longevity impacts. (As noted and reports that deaths per 1,000 patient Jesse Schold, ‘‘Measuring transplant above, however, even in the absence of years are about 180 for dialysis patients center performance: The goals are not health and longevity effects, there may and about 32 for transplant recipients controversial but the methods and be other benefits, such as reduced travel (see 2016 report, volume 2, Figure i.13 consequences can be,’’ Curr Transplant costs, if the proposed rule reduces and Tables H.4 and H.10; accessed at Rep, March 2017, 4(1), 52–58. Using concentration of transplants in a smaller https://www.usrds.org/adr.aspx). There past data to measure potential effects, number of facilities.) Therefore, we have are similar data on other organs. For these studies predict little or no positive shown the effects of the proposed example, in 1998, HHS published a final effect from the revised standards (which change as ‘‘not quantified.’’ This is not rule with comment period that both studies conclude will still mis- unusual in Regulatory Impact Analyses established governance procedures for identify lower performing programs), that address complex phenomena that the OPTN (63 FR 16296). In the RIA for but cannot evaluate actual effects cannot be measured directly, or whose that rule, the Department estimated that because post-issuance evidence is not effects are intertwined with other ‘‘the annual benefits of organ yet available. This may not be relevant changing circumstances. That said, we transplantation include about eleven policy-wise, since we propose to welcome any additional information thousand lives vastly improved by eliminate those standards, but it is a key that might allow a quantitative estimate kidney transplantation, and another question for estimating the remaining in the final rule. eight thousand lives both vastly scope (if any) of CoP-associated Every transplant quality organ that is improved and prolonged by unnecessary organ discards, and it does used for transplantation rather than transplantation of other major organs’’ flag the pervasive problem of timeliness discarded has a very high probability of (63 FR 16323). Even without a robust aggregate of data and timeliness of study findings. substantially extending the life of the There are several studies that make estimate of likely increases in organ recipient. There is a particularly similar estimates for liver transplant utilization as a result of this proposed extensive literature on life expectancy programs (for example, L.D. Buccini, et regulatory change, the potential benefits before and after transplant, quality of al., ‘‘Association Between Liver are very substantial. For each new Transplant Center Performance life, and cost savings for kidney kidney transplantation, there would be Evaluations and Transplant Volume,’’ patients. A literature synthesis on ‘‘The an average of 10 additional life years per American Journal of Transplantation Cost-Effectiveness of Renal transplant patient compared to those on 2014, 2097–2105). This study found a Transplantation,’’ by Elbert S. Huang, dialysis (see Wolfe A. et al., large difference in transplant volume Nidhi Thakur, and David O. Meltzer, in ‘‘Comparisons of Mortality in All between programs rated as lower Sally Satel, When Altruism Isn’t Enough Patients on Dialysis, Patients on Dialysis performing by the SRTR (average (AEI Press, 2008) found essentially Awaiting Transplantation, and decrease of 39.9 transplants from 2007 universal agreement that kidney Recipients of a First Cadaveric to 2012) and those not receiving adverse transplants were not only substantially Transplant,’’ NEJM, 1999, 341:1725–30; SRTR ratings (average increase of 9.3 life extending, but also cost reducing. accessed at http://www.nejm.org/doi/ transplants over the same period). The The authors performed an extensive full/10.1056/NEJM199912023412303 27 lower performing centers thus literature search and found that from #t=article). Valuing each year of life reduced their total number of liver 1968 to 2007 seventeen studies assessed gained using a ‘‘value of a statistical life transplants by over 1,000, and compared the cost-effectiveness of renal year’’ (VSLY) of $490,000 in 2014 to the higher performing centers the transplantation. The authors concluded dollars, the total benefits from each decrease was even larger. This study did that ‘‘Renal transplantation . . . is the additional transplantation in 2018 not, however, tie its estimates to the most beneficial treatment option for would be $4.9 million before performance standards in the 2007 rule patients with end-stage renal disease discounting and $4.4 million after (which are similar but not identical to and is highly cost-effective compared to inflating to 2016 dollars and SRTR standards), to sanctions under no therapy. In comparison to dialysis, discounting at either 3 percent over the that rule, or to specific center decisions, renal transplantation has been found to 10-year period (life-year figure for 2014 such as removing candidates from the reduce costs by nontrivial amounts from Office of the Assistant Secretary wait list. Hence, while it certainly while improving health both in terms of for Planning and Evaluation, HHS, contributes to the body of scholarship the number of years of life and the Guidelines for Regulatory Impact indicating that since 2007 transplants quality of those years of life’’ (page 31). Analysis, 2016, page 21, accessed at have been performed in a more More recent studies have reached https://aspe.hhs.gov/pdf-report/ concentrated set of programs, it does not similar conclusions, as have other guidelines-regulatory-impact-analysis). appear to provide direct estimates of the syntheses. For example, the ‘‘Systematic The HHS methodology produces the quantitative effects of the 2007 rule on Review: Kidney Transplantation same result at either discount rate in overall numbers of liver transplants. Compared with Dialysis in Clinically order to reach the same predetermined Taking into account all the various Relevant Outcome’’ (M. Tonelli, N. ‘‘real’’ value. For an explanation and uncertainties involved in these studies, Wiebe, G. Knoll, A. Bello, S. Browne, D. justification of this VSLY approach, see we do not believe that we can estimate Jadhov, S. Klarenbach, and J. Gill, Cass R. Sunstein, ‘‘Lives, Life-Years, and the effects of the 2007 rule on numbers American Journal of Transplantation Willingness to Pay,’’ 104 Columbia Law of transplantations for any organ other 2011: 2093–2109) focused on life Review [i] (2004). than kidneys, and that even for kidneys expectancy and quality of life. This Those HHS guidelines also explain in there is no clear central estimate of article reviewed 110 studies, and some detail the concept of quality likely quantitative effects. The wide concluded that the vast majority showed adjusted life years. The key point to variation in published results, and the major improvement in life quality and understand is that these are research- disclaimers as to the various reductions in mortality among based estimates of the value that people

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are willing to pay for life-prolonging and seek any empirical evidence that positive and adverse incentives for and life-improving health care would allow robust estimates of transplant programs, with unanticipated interventions of any kind (see sections benefits, and in particular robust side effects on both utilization of 3.2 and 3.3 of the HHS Guidelines for quantitative estimates of the number of donated organs and the ability of the a detailed explanation). The QALY patients deprived of transplantation as a highest risk patients to obtain amount used in any estimate of overall result of the 2007 rule, as currently transplants. We expect the proposed benefits is not meant to be a precise implemented to reflect the 2016 change to provide substantial net estimate, but instead is a rough guidance, for each organ type. We also benefits, particularly since other statistical measure that allows an overall welcome comments on whether we have regulatory and informational incentives estimate of benefits expressed in dollars. accurately and reasonably summarized remain in place. An alternative and more sophisticated the research evidence on the effects of We welcome comments on this analysis would take into account that the 2007 rules, particularly in the light analysis as well as information that the life-extending effect of a kidney of the many other factors influencing would enable a more robust quantitative transplant is not its first effect, but transplantation trends and performance. analysis of the impacts of this change typically follows a number of years off We note that life-extending estimates and on any alternative reforms that dialysis, until the organ fails and the are averages across patients who vary might provide even higher benefits. patient returns to dialysis or is widely in age, medical condition, and 6. Effects on HHAs retransplanted. Such an analysis can be life expectancy, as well as type of organ found in a recent study by P.J. Held et failure. For example, the sickest patients As of May 2017 there are 12,624 al., ‘‘A Cost-Benefit Analysis of typically have very low life HHAs that participate in Medicare and Government Compensation of Kidney expectancies without transplant, and Medicaid. In the January 2017 HHA CoP Donors,’’ American Journal of hence stand to gain the most years of final rule (82 FR 4149) we estimated Transplantation, 2016, pages 877–885 life from a transplant. Partly offsetting that compliance with the requirements (plus 65 pages of supplementary details this, these same patients, on average, at § 484.50(a)(3) related to providing explaining all assumptions, data have slightly lower survival rates post- oral notice of all rights to each patient sources, and calculations). The largest transplant. Organ and patient survival would impose a burden of 5 minutes per differences between the base case issues are complex and dealt with by patient, or 330,246 hours of burden estimated in that study and the detailed policies and procedures nationwide at a cost of $80,030,370, preceding estimates is that this RIA uses developed and used by the transplant annually. The cost estimate was based the considerably higher value of a community under the auspices of the on a $63 per hour estimate for the statistical year of life under HHS OPTN. These policies are reviewed and services of a RN as derived from the BLS guidelines, and this RIA uses the full revised frequently based on actual Occupational Handbook, 2014–2015 value of a statistical life year without a experience and changing technology— edition, including a 100 percent benefit ‘‘quality’’ adjustment for the added over time the success rate from and overhead package. Adjusted to years of life (we use QALYs only for the previously marginal organs, and in older reflect more updated salary information, improved quality of life during years patients, have both increased as described previously, we estimate that would otherwise be on kidney substantially. For purposes of this that compliance with this provision dialysis). Under such an estimation analysis, the proper measure is the would impose a $91,786,974 burden, approach, potential life-extending average gain across all patients who based on a RN earning $69 per hour. benefits could be somewhat larger. For would receive transplants as a result of We propose to revise the verbal example, if the proposed reform eliminating the 2007 rule, net of these notification requirements to limit them increased the number of life-extending other factors. to those that are required by section kidney transplants by only 100 a year, There could be potential offsets to 1891 of the Act. Limiting the amount of and the benefits of both additional life these calculated and uncalculated information that is required to be years and QALY gains were estimated at benefits and cost reductions. However, provided orally will reduce the time per $5.1 million per patient, its total annual the particular regulatory requirements patient that is required to comply with benefits for kidney patients would be we propose to remove are unlikely to the revised requirement. For purposes of approximately $510 million a year (100 drive any further significant increases in this analysis only, we assume that × $5.1 million). graft and patient survival. For renal providing oral notice regarding financial There are additional benefits from transplants, the expected 1-year graft liability only will require 2 minutes per kidney transplantation. As previously and patient survival rates are already at patient, reducing burden by 60 percent. discussed, kidney transplants do reduce 95 percent or better. Transplant program Based on this assumption, this proposed medical costs, with ‘‘breakeven’’ after outcomes will continue to be monitored change would reduce the burden of the about 5 years and net savings of several by the OPTN and programs that are not patient rights notification requirement hundred thousand dollars per patient. in compliance with the OPTN outcomes by 198,148 hours (330,246 hours Other organ transplants create lesser or are referred to their Membership and originally estimated × 0.6) and no medical savings because the Professional Standards Committee for $55,072,184 ($91,786,974 burden as alternative is not dialysis. Clearly, quality improvement activities. The updated to reflect more recent salary however, these kidney transplant SRTR also publishes detailed data on estimates × 0.6). savings are small in relation to the life- transplant program performance that We also propose two changes that do extending benefits. We have not allows patients and their physicians to not have a savings estimate. First, we estimated medical savings or costs for compare transplant programs and this propose to eliminate the requirement at kidneys or other organs in this RIA transparency creates pressures to § 484.80(h)(3) that the HHA conduct a because any such estimates would maintain and improve survival rates in full competency evaluation of deficient depend on the number of additional order to attract these patients. home health aides, and replace it with transplants that we have not estimated. The current regulatory requirements a requirement to retrain the aide We welcome comments on the for transplant centers, as discussed in regarding the identified deficient skill(s) quantitative and non-quantitative section II.E ‘‘Transplant Centers’’ of this and require the aide to complete a portions of the preceding discussion proposed rule, have created both competency evaluation related to those

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skills. As we stated in the January 2017 suppliers employing an estimated 5,000 calculate the economic impact and the HHA CoP final rule (82 FR 4575), it is portable x-ray technologists. Hiring costs associated with the proposed standard practice within the HHA limited x-ray technologists or those with changes to the emergency preparedness industry to supervise home health aides, State licensure would allow portable x- requirements is the same methodology and the regulatory requirements for ray suppliers to fill vacant positions at used to calculate the economic impact such supervision do not impose any a lower hourly cost. Assuming a 10 in the Emergency Preparedness final additional burden. percent annual turnover rate, all rule (81 FR 63860). Second, we propose to remove the technologists could be hired at the At § 482.15(a), (b), (c), and (d) for requirement at § 484.110(e) related to lower salary over a period of 10 years. hospitals and parallel regulatory providing a requested copy of the Limited x-ray technologists can be hired citations for other facilities, we propose clinical record at the next home visit, for approximately $30 an hour ($62,400 to allow providers to review their while retaining the requirement to per year), whereas, according to the program at least every 2 years. We provide the record within 4 business BLS, x-ray technologists with advanced discuss the economic impact for this days. As stated in the January 2017 certification (ARRT) are hired at a rate requirement in the ICR section of this HHA CoP final rule (82 FR 4568 and of approximately $60 dollars per hour rule, which represents $94,312,719 in 4575), we believe that providing such ($124,800 per year). This creates a savings. information to patients is a usual and savings opportunity of $30 per hour, or At § 482.15(a)(4) for hospitals, and customary practice that does not impose $62,400 per year, per technologist other parallel citations for the facilities a burden upon HHAs. As such, position. Based on an assumed 10 mentioned in section II.J.2 of this removing the ‘‘next home visit’’ percent turnover rate, or 500 positions proposed rule, we propose to eliminate timeframe requirement would not result filled in any given year, this change the requirement that facilities document in a savings of burden hours or dollars. would create a savings of $31,200,000 efforts to contact local, tribal, regional, We welcome public comment savings in the first year. We believe that State, and Federal emergency regarding these burden estimates, and these savings would be increased every preparedness officials and that facilities additional regulatory reforms to reduce year as more positions are filled at the document participation in collaborative the burden of the HHA CoPs. lower salary rate. and cooperative planning efforts. We We welcome public comment discuss the economic impact for this 7. Effects on CAHs regarding these burden estimates, and requirement in the ICR section of this We propose to remove the additional regulatory reforms to reduce rule, which represents $7,179,117 in requirement at § 485.627(b)(1) for CAHs the burden of the portable x-ray CfCs. savings. At § 482.15(d)(1)(ii) for hospitals, and to disclose to CMS its owners or those 11. Effects on RHCs and FQHCs with a controlling interest in the CAH other parallel citations for other or any subcontractor in which the CAH We discussed the burden reduction facilities mentioned in section II.J.2 of directly or indirectly ha a 5 percent or for our proposed revision of this proposed rule, we propose to more ownership interest in accordance § 491.9(b)(4) ‘‘review of patient care require that facilities provide training with 42 CFR part 420, subpart C. We policies’’ requirements imposed on biennially, or every 2 years, after discuss the economic impact of this RHCs and FQHCs in the ICR section, facilities conduct initial training on provision in the ICR section, which is which is an estimated savings of $6.8 their emergency program. In addition, estimated at $141,000 total for all CAHs. million. In addition, the burden we propose to require additional We discussed the burden reduction for reduction for our proposed revision of training when the emergency plan is our proposed revision of the ‘‘patient § 491.11(a) ‘‘program evaluation’’ significantly updated. We discuss the care policies’’ requirements imposed on requirements imposed on RHCs and economic impact for this requirement in CAHs in the ICR section of this rule, FQHCs in the ICR section of this rule, the ICR section of this rule, which which is estimated at $2.5 million. which is an estimated savings of $9.4 represents $33,267,864 in savings. million. Finally, at § 482.15(d)(2), we propose to 8. Effects on CORFs require that providers of inpatient 12. Effects of Emergency Preparedness We discussed the burden reduction services mentioned in section II.J.2 of Requirements on Providers and this proposed rule conduct two testing for our proposed revision of the Suppliers ‘‘utilization review plan’’ requirements exercises annually, one of which may be imposed on CORFs in the ICR section of This proposed rule revises the an exercise of their choice that must be this rule, which is estimated at emergency preparedness requirements either a community-based full-scale $309,072. for Medicare and Medicaid participating exercise (if available), an individual providers and suppliers, as discussed in facility-based functional exercise, a 9. Effects on CMHCs detail in section II.M of this proposed drill, a tabletop exercise or workshop We discussed the burden reduction rule. The proposed modifications to the that includes a group discussion led by for our proposed revision of emergency preparedness requirements a facilitator. We propose to require that § 485.914(d)(1) ‘‘update of the either simplify the requirements, providers of outpatient services comprehensive assessment’’ eliminate duplicative requirements, or mentioned in section II.J.2 of this requirements imposed on CMHCs in the reduce the frequency in which proposed rule conduct one testing ICR section, which is an estimated providers would need to comply with exercise annually which must be either savings of $152,464. the emergency preparedness a community-based full-scale exercise requirements. We estimate that the (if available) or an individual facility- 10. Effects on Portable X-Ray Services proposed changes to the emergency based functional exercise every other At § 486.104 we propose to revise the preparedness requirements would year, and in the opposite years, may be portable x-ray CfCs to focus on the accrue an annual cost savings of $155 either a community-based full-scale qualifications of the technologist million in total. The potential, estimated exercise (if available), a facility-based performing the diagnostic test. As of cost savings for each revised emergency functional exercise, a drill, or a tabletop May 2017 there were approximately 500 preparedness requirement is outlined in exercise or workshop that includes a Medicare-participating portable x-ray detail below. The methodology used to group discussion led by a facilitator. We

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discuss the majority of this economic this provision for CORFs and • HHAs: Combined total savings of impact for this requirement in the ICR Organizations will be limited to the $2,632,104 ((2 hours for an section, which represents $9,117,425 in estimated ICR burden of $55,272 and administrator at $105 per hour plus 3 savings. We do not estimate any $305,172, respectively. hours for a director of training at $69 economic impact for the providers of We estimate a total impact savings of per hour) × 12,624 HHAs × 50 percent). $10,997,373 for this proposed change. inpatient services as we are not • CMHCs: Combined total savings of With an estimated ICR savings of proposing any changes to the number of $58,926 ((5 hours for an administrator at $9,117,425, we estimate that the total testing exercises that must be conducted $105 per hour plus 3 hours for a nurse economic impact of this rule for the by these providers; however, we at $69 per hour) × 161 CMHCs × 50 affected providers will be $20,114,798. estimate an additional economic impact percent). for this provision for each outpatient We list a summary of the calculation for • OPOs: Combined total savings of provider due to a reduction in the the impact savings accrued by removing $5,046 ((1 hour for a QAPI Director at testing requirement from two exercises this requirement for each facility in Table 15, based on facility numbers $105 per hour plus 1 hour for an per year to one exercise per year. We available as of May 2017. education coordinator at $69 per hour) would like to note that for CORFs and • ASCs: Combined total savings of × 58 OPOs × 50 percent). Organizations, consistent with the $1,967,178 for 5,557 ASCs ((4 hours for • Emergency Preparedness Final Rule RHCs/FQHCs: Combined total an administrator at $108 per hour plus savings of $ 4,187,832 (((4 hours for an (Medicare and Medicaid Programs; 4 hours for a registered nurse at $69 per Emergency Preparedness Requirements × × administrator at $105 per hour plus 4 hour) 5,557 ASCs 50 percent). hours for a registered nurse at $69 per for Medicare and Medicaid Participating • Outpatient Hospice: Combined total hour) × 4,160 RHCs × 50 percent) plus Providers and Suppliers; Final Rule, 81 savings of $1,405,920 ((4 hours for an (4 hours for an administrator at $105 per FR 63860), the CoPs for these providers administrator at $105 per hour plus 4 previously required them to have hour plus 4 hours for a registered nurse hours for a registered nurse at $69 per × × ongoing drills and exercises to test their hour) × 4,040 outpatient hospices × 50 at $69 per hour) 7,874 FQHCs 50 disaster plans. Therefore, we continue percent). percent). to expect, as we did in the Emergency • PACE: Combined total savings of • ESRDs: Combined total savings of Preparedness final rule, that the $16,077 ((1 hour home for a care $724,290 ((1 hour for an administrator at economic impact to comply with this coordinator at $69 per hour plus 1 hour $105 per hour plus 1 hour for a nurse requirement will be minimal, if any. for a quality improvement nurse at $69) manager at $105 per hour) × 6,898 Therefore, the total economic impact of × 233 PACEs × 50 percent). dialysis facilities × 50 percent).

TABLE 15—COST SAVINGS FOR EMERGENCY PREPAREDNESS TESTING

Cost savings Provider/supplier per provider/ Combined total savings supplier

ASCs ...... $354 $1,967,178 for 5,557 ASCs. Hospices (outpatient) ...... 348 $1,405,920 for 4,040 outpatient hospice facilities. PACEs ...... 69 $16,077 for 233 PACEs. HHAs ...... 209 $2,632,104 for 12,624 HHAs. CMHCs ...... 366 $58,926 for 161 CMHCs. OPOs ...... 87 $5,046 for 58 OPOs. RHCs/FQHCs ...... 348 $4,187,832 for RHCs and FQHCs ($1,447,680 for 4,160 RHCs and $2,740,152 for 7,874 FQHCs). ESRD Facilities ...... 105 $724,290 for 6,898 dialysis facilities.

13. One-Time Implementation Costs medical histories and physical regulatory change(s) and make the All of the changes presented above examinations will be required or appropriate changes in procedures. We will necessarily have to be read, and encouraged as a matter of policy. Rather further estimate that for one tenth of understood, and implemented by than attempt to estimate these these providers, 2 hours of physician affected providers. This will create one- situational variables in detail for each time will be needed to consider changes time costs even though the underlying facility type, we believe it possible to in facility policy. Average hourly costs change reduces burden. In most cases make reasonable overall estimates of for these professions, with wage rates these costs will be very low, and may these one-time costs, recognizing that doubled to account for fringe benefits be as simple as observing that a there will be considerable variations and overhead costs, are $134 for particular procedure will need only to among provider types and among lawyers, $105 for managers, $70 for be performed once rather than twice a individual providers. registered nurses, and $198 for year, and changing the schedule In total, there are about 122 thousand physicians. These numbers are from accordingly. In some cases, the facility affected entities, as shown in the Table BLS statistics for 2016, at https:// _ will need to adjust in response to 17 that follows. We assume that on www.bls.gov/oes/2016/may/oes multiple burden reduction changes. In average there will be 1 hour of time nat.htm. still other cases, time will have to be spent by a lawyer, 2 hours of time by an The estimated costs for an average spent deciding how to change existing administrator or health services provider would therefore be 1 hour at policy. For example, as discussed manager, and 2 hours of time by other $134 and in total for the lawyers, 2 previously, ASCs and hospital staff (we assume registered nurses or hours at $105 or $210 in total for the outpatient facilities will need to decide equivalent in wage costs) of each managers, 2 hours at $69 or $138 in total whether and in what circumstances affected provider to understand the for the other staff, and two-tenths of 1

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hour at $198 or $40 in total for the to $522 per provider on average, and in physicians. These one-time costs add up total to about $64 million.

TABLE 16—ONE-TIME IMPLEMENTATION COSTS

Number of Provider type affected providers

Religious Nonmedical Health Care Institutions ...... 18 Ambulatory Surgical Centers and hospital outpatient ...... 10,587 Hospices ...... 4,602 Hospitals ...... 5,031 Transplant programs ...... 750 Home Health Agencies ...... 12,624 Critical Access Hospitals ...... 1,343 Comprehensive Outpatient Rehabilitation Facilities ...... 188 Community Mental Health Centers ...... 52 Portable X-Ray Services ...... 500 Rural Health Clinics and Federally Qualified Health Centers ...... 12,034 Emergency Preparedness of Providers and Suppliers ...... 74,246

Total Number of Providers ...... 122,180 Average Cost Per Provider ...... $522

Total One-Time Cost ...... $63,777,960

13. Effects on Small Entities, Effects on number of affected entities will be about mandates that will impose spending Small Rural Hospitals, Unfunded 122,000, including those affected by costs on State, local, or tribal Mandates, and Federalism more than one provision. The rule of governments, or on the private sector. thumb used by HHS for determining Indeed, it substantially reduces existing The RFA requires agencies to analyze whether an impact is ‘‘significant’’ is an private sector mandates. options for regulatory relief of small effect of 3 percent or more of annual Executive Order 13132 establishes entities, if a rule has a significant impact revenues. These savings do not certain requirements that an agency on a substantial number of small approach that threshold. Hospitals must meet when it promulgates a entities. For purposes of the RFA, we account for about one-third of all health proposed rule (and subsequent final estimate that almost all health care care spending and even if all these rule) that imposes substantial direct providers regulated by CMS are small savings accrued to hospitals this requirement costs on State and local entities as that term is used in the RFA threshold would not be approached. governments, preempts State law, or (including small businesses, nonprofit Therefore, the Secretary has determined otherwise has federalism implications. organizations, and small governmental that this proposed rule will not have a This proposed rule imposes no such jurisdictions). The great majority of significant economic impact on a requirements. Importantly, it would hospitals and most other health care substantial number of small entities. remove Federal requirements setting providers and suppliers are small In addition, section 1102(b) of the qualification standards for hospice entities, either by being nonprofit Social Security Act requires us to aides. Setting qualifications for health organizations or by meeting the SBA prepare a regulatory impact analysis if care workers is traditionally a State definition of a small business (having a rule may have a significant impact on function, and this change would revenues of less than $7.5 million to the operations of a substantial number therefore remove an infringement on $38.5 million in any 1 year, varying by of small rural hospitals. This analysis State prerogatives. type of provider and highest for must conform to the provisions of hospitals). Accordingly, almost all of the section 603 of the RFA. For purposes of 14. Effects on Costs to Facilities, savings that this proposed rule would section 1102(b) of the Act, we define a Providers, Medicare, Other Insurance, create will benefit small entities. We small rural hospital as a hospital that is and Patients note that individual persons are not located outside of a metropolitan Most of the individual proposals small entities for purposes of the RFA, statistical area and has fewer than 100 addressed in the preceding analysis and hence the life-extending beds. For the reasons previously given, involve reducing burdensome costs on transplantation benefits of the proposed the Secretary has determined that this facilities, health care professionals, and rule are not relevant to the RFA. proposed rule will not have a significant patients. Most of those reductions save The RFA requires that a Regulatory impact on the operations of a substantial time and effort currently performed on Flexibility Analysis (RFA) be prepared number of small rural hospitals. tasks that we propose to eliminate or if a proposed rule would have a Section 202 of the Unfunded reform and those reductions will result ‘‘significant impact on a substantial Mandates Reform Act of 1995 (UMRA) ultimately in reduced medical care costs number’’ of such entities. HHS also requires that agencies assess in these facilities, some of which will interprets the statute as mandating this anticipated costs and benefits before result in further effects on public and analysis only the impact is adverse, issuing any rule whose mandates private insurance costs. In this regard, it though there are differing require spending in any 1 year of $100 is important to emphasize that the CoPs interpretations. Regardless, there is no million in 1995 dollars, updated and CfCs generally apply to all patients question that this proposed rule would annually for inflation. In 2018, that served by a Medicare and/or Medicaid affect a ‘‘substantial number’’ of small threshold is approximately $148 participating provider or supplier, not entities. As shown in Table 17, the total million. This proposed rule contains no just Medicare or Medicaid patients, and

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to the entire operations of the provider. each affected entity for those particular surgery) performed in ASCs and in Revisions to those requirements apply costs. According to the National Health hospital outpatient surgery will broadly to the entire health care system. Expenditure Accounts, approximate disproportionately reduce Medicare We are hopeful that cost reductions payer shares in 2016 were 11 percent for costs, since use of these services rises ultimately flow to reductions in charges, consumer out of pocket, 35 percent for with age. Additional transplantation of to reductions in third party payments, private health insurance, 21 percent for kidneys will reduce Medicare’s ESRD and hence to reductions in insurance Medicare, 18 percent for Medicaid, and costs, partially offset by increased costs and to those who pay those costs. 15 percent for other public and private transplantation costs. Because of the In total, we estimate that the payers such as the Department of difficulty in finding evidence of the approximately 40 specific provisions Veteran Affairs and the Department of volume of such savings, we cannot summarized in Tables 1 and 2 that are Defense. We would expect savings to estimate the likely effects on Medicare not related to reductions in pre- approximate these shares. Ultimately, spending. operative physical examinations and all costs are paid by workers and Most of the facility and provider tests in outpatient surgery, or to taxpayers who pay for all health care savings will accrue to Medicare and transplantation, will save facilities and directly or indirectly, quite apart from other providers, insurers, and patients immediate cost subsidies or cost other insurers over time as payment rate about $669 million annually. The initial sharing. increases are slightly reduced, and the savings will accrue primarily to Two provisions directly reduce remainder will accrue to other payers providers. How much of these savings Medicare and other insurance costs. and to patients. will flow to insurers and patients Eliminating unnecessary patient history The following table shows our depends primarily on the payment and and physical examinations and medical estimates of savings by major burden reimbursement mechanisms in place for tests for procedures (such as cataract reduction category and by type of payer.

TABLE 17—SAVINGS BY MAJOR PAYER CATEGORIES [$ Millions]

Ambulatory All other cost Savings to: surgery Transplant programs reductions Total

Medicare ...... 123 not estimated...... 141 264 Medicaid ...... 57 not estimated...... 120 177 Private Insurance ...... 110 not estimated ...... 234 344 Other Payers ...... 47 not estimated ...... 100 147 Patients ...... 117 not estimated...... 74 191

Total ...... 454 not estimated...... 669 1,123 Note: Calculations based largely on payer percentages in ‘‘National Health Care Spending in 2016,’’ Health Affairs, January 2018, pages 150– 160. Patient share for ambulatory surgery savings reflects travel time, not medical costs.

15. Benefits to Patients reform as identified by stakeholders, by suggest the potential savings these recent research, or by experts as reforms could achieve under certain We discussed life-extending and life- unusually burdensome. This subset of assumptions. We appreciate that those saving benefits at length in the analysis the universe of standards is the focus of assumptions are simplified, and that of increases in transplantation. These this proposed rule. For all of the actual results could be substantially result from removal of disincentives to proposed provisions, we considered not higher or lower. Although there is transplant patients, or to use organs, making these changes. Ultimately, we uncertainty concerning the magnitude where this could reduce success rates by saw no good reasons not to propose of all of our estimates, we do not have a few percent and possibly trigger these burden reducing changes. the data to provide specific estimates for closure of transplant centers or We welcome comments on whether each reform proposed, as to the range of programs under current rules. As we properly selected the best candidates possibilities, or to estimate all categories previously explained, we do not have for change, and welcome suggestions for of possible benefits, including health robust estimates. There are additional additional reform candidates from the effects. and substantial patient benefits likely to entire body of CoPs and other regulatory result from the cost-reducing reforms provisions that fall directly on F. Accounting Statement and Table that we propose. Time not wasted by providers. As required by OMB Circular A–4 medical care providers or facilities on (available at https:// unnecessary tasks is time that can be E. Uncertainty obamawhitehouse.archives.gov/omb/ used to focus on better care. While such Our estimates of the effects of this circulars_a004_a-4/), in Table 18, we effects could be measured in principal, regulation are subject to significant have prepared an accounting statement there is little existing data on uncertainty. While the Department is showing the classification of the magnitudes of such effects. We do, confident that these reforms will transfers and costs associated with the however, welcome public comments on provide flexibilities to facilities that will various provisions of this proposed rule. these or any other aspects of costs and yield major cost savings, there are While most provisions of the benefits of the proposed rule. uncertainties about the magnitude of proposed rule have clearly predictable D. Alternatives Considered these effects. Despite these effects we do not in most cases have uncertainties, we are confident that the detailed empirical information on the From within the entire body of CoPs rule will yield substantial overall cost precise magnitude of efforts involved and CfCs, we selected what we believe reductions and other benefits. In this (for example, time spent in meeting to be the most viable candidates for analysis we have provided estimates to paperwork or other administrative tasks

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that apply to a particular provider type). have estimated an upper and lower level lower bound is zero cost reductions and Other provisions (notably those related for benefit and cost reduction estimates our upper bound is a 50% reduction in to organ transplantation and removal of that is 25 percent higher or lower than H&P and associated laboratory testing strict H & P requirements before our primary estimate for all quantified costs. ambulatory surgery) have even more reforms other than those related to uncertain effect sizes. Therefore, we ambulatory surgery, and in that area our

TABLE 18—ACCOUNTING STATEMENT: CLASSIFICATION OF ESTIMATED BENEFITS AND SAVINGS [$ Millions]

Units Category Primary Lower Upper Discount estimate bound bound Year dollars rate Period (%) covered

Life-Extending Benefits (monetized) ...... Not Quantified

Medical Cost Reduction Benefits (monetized) ...... Not Quantified

Other Cost Reductions (monetized) ...... ¥$1,240 ¥$580 ¥$1,890 2016 7 2018 onward. ¥$1,250 ¥$590 ¥$1,900 2016 3 2018 onward.

Costs ...... None

Transfers ...... None

G. Reducing Regulation and Controlling some provisions, health benefits to Medicaid, Penalties, reporting and Regulatory Costs patients will be substantial and direct. recordkeeping requirements. Other provisions will free up time and Executive Order 13771, titled 42 CFR Part 460 efforts of health care providers to focus Reducing Regulation and Controlling Aged, Health care, Health records, Regulatory Costs, was issued on January on improving health care quality and service delivery. Although this Medicaid, Medicare, Reporting and 30, 2017 and requires that the costs recordkeeping requirements. associated with significant new proposed rule does not require an Initial regulations ‘‘shall, to the extent Regulatory Flexibility Analysis, this 42 CFR Part 482 regulatory impact analysis, together permitted by law, be offset by the Grant program—health, Hospitals, elimination of existing costs associated with the remainder of this preamble, meets the requirements for such an Medicaid, Medicare, Reporting and with at least two prior regulations.’’ recordkeeping requirements. This proposed rule will, if finalized as analysis. Furthermore, the analysis in proposed, be considered an E.O. 13771 this section of the preamble, together 42 CFR Part 483 deregulatory action. We estimate that with the remainder of this preamble, Grant programs—health, Health this rule generates $1,051 million in provides a complete Regulatory Impact facilities, Health professions, Health annualized cost savings, discounted at 7 Analysis. records, Medicaid, Medicare, Nursing percent relative to year 2018, over a In accordance with the provisions of home, Nutrition, Reporting and perpetual time horizon. This estimate is Executive Order 12866, this regulation recordkeeping requirements, Safety. was reviewed by the Office of based on cost reductions starting at 42 CFR Part 484 $1,123 million, and growing by $31 Management and Budget. Health facilities, Health professions, million annually due to salary savings List of Subjects from X-ray technician turnover, Medicare, Reporting and recordkeeping partially offset by one-time first-year 42 CFR Part 403 requirements. implementation costs of $64 million, all Grant programs—health, Health 42 CFR Part 485 in 2016 dollars. Details on the estimated insurance, Hospitals, Intergovernmental Grant programs—health, Health cost savings from this rule can be found relations, Medicare, Reporting and facilities, Medicaid, Reporting and in the preceding analysis. We note that recordkeeping requirements. recordkeeping requirements. public comments and additional information may enable us to estimate 42 CFR Part 416 42 CFR Part 486 considerably larger savings from Grant programs—health, Health reforming H & P requirements for Health facilities, Health professions, Medicare, Reporting and recordkeeping facilities, Medicare, Reporting and ambulatory surgery or to narrow the recordkeeping requirements, X-rays. uncertainty within the range of the requirements. preliminary estimates. 42 CFR Part 418 42 CFR Part 488 H. Conclusion Administrative practice and Health facilities, Hospice care, procedures, Health facilities, Health This proposed rule would Medicare, Reporting and recordkeeping professions, Medicare, reporting and substantially reduce existing regulatory requirements. recordkeeping requirements. requirements imposed on health care 42 CFR Part 441 providers through the CoPs and related 42 CFR Part 491 regulatory provisions that Medicare and Aged, Family planning, Grant Grant programs—health, Health Medicaid providers must meet. For programs-health, Infants and children, facilities, Medicaid, Medicare,

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Reporting and recordkeeping § 403.748 Condition of participation: Authority: Secs. 1102, 1138, and 1871 of requirements, Rural and Urban areas. Emergency preparedness. the Social Security Act (42 U.S.C. 1302, * * * * * 1320–8, and 1395hh) and section 371 of the 42 CFR Part 494 (a) Emergency plan. The RNHCI must Public Health Service Act (42 U.S.C. 273)). Health facilities, Diseases, Medicare, develop and maintain an emergency § 416.41 [Amended] Reporting and recordkeeping preparedness plan that must be ■ 5. Section 416.41 is amended by requirements. reviewed, and updated at least every 2 removing paragraph (b)(3). For the reasons set forth in the years. The plan must do all of the ■ 6. Section 416.47 is amended by preamble, the Centers for Medicare & following: revising paragraph (b)(2) to read as Medicaid Services proposes to amend * * * * * follows: 42 CFR chapter IV as set forth below: (4) Include a process for cooperation and collaboration with local, tribal, § 416.47 Condition for coverage—Medical PART 403—SPECIAL PROGRAMS AND regional, State, and Federal emergency records. PROJECTS preparedness officials’ efforts to * * * * * maintain an integrated response during (b) * * * ■ 1. The authority citation for part 403 a disaster or emergency situation. (2) Significant medical history and continues to read as follows: (b) Policies and procedures. The results of physical examination (as Authority: 42 U.S.C. 1395b-3 and Secs. RNHCI must develop and implement applicable). 1102 and 1871 of the Social Security Act (42 emergency preparedness policies and * * * * * U.S.C. 1302 and 1395hh). procedures, based on the emergency ■ 7. Section 416.52 is amended by ■ 2. Section 403.736 is amended by— plan set forth in paragraph (a) of this revising the section heading and ■ a. Removing the introductory text; section, risk assessment at paragraph paragraph (a) to read as follows: (a)(1) of this section, and the ■ b. Revising paragraph (a); § 416.52 Condition for coverage—Patient ■ communication plan at paragraph (c) of c. Removing paragraph (b); and this section. The policies and admission, assessment and discharge. ■ d. Redesignating paragraphs (c) and procedures must be reviewed and * * * * * (d) as paragraphs (b) and (c). updated at least every 2 years. At a (a) Standard: Patient assessment and The revision reads as follows: minimum, the policies and procedures admission. (1) The ASC must develop § 403.736 Condition of participation: must address the following: and maintain a policy that identifies Discharge planning. * * * * * those patients who require a medical history and physical examination prior (a) Discharge planning and (c) Communication plan. The RNHCI must develop and maintain an to surgery. The policy must— instructions. The RNHCI must have in (i) Include the timeframe for medical effect a discharge planning process that emergency preparedness communication plan that complies with history and physical examination to be applies to all patients. The process must completed prior to surgery. assure that appropriate post-institution Federal, State, and local laws and must be reviewed and updated at least every (ii) Address, but is not limited to, the services are obtained for each patient, as following factors: Patient age, diagnosis, necessary. The RNHCI must assess the 2 years. The communication plan must include all of the following: the type and number of procedures need for a discharge plan for any patient scheduled to be performed on the same * * * * * likely to suffer adverse consequences if surgery date, known comorbidities, and (d) Training and testing. The RNHCI there is no planning. the planned anesthesia level. must develop and maintain an (1) Discharge instructions must be (iii) Follow nationally recognized emergency preparedness training and provided at the time of discharge to the standards of practice and guidelines, testing program that is based on the patient or the patient’s caregiver as and applicable State and local health emergency plan set forth in paragraph necessary. and safety laws. (a) of this section, risk assessment at (2) If the patient assessment indicates (2) Upon admission, each patient paragraph (a)(1) of this section, policies a need for a discharge plan, the must have a pre-surgical assessment and procedures at paragraph (b) of this discharge plan must include completed by a physician who will be section, and the communication plan at instructions on post-RNHCI care to be performing the surgery or other paragraph (c) of this section. The used by the patient or the caregiver in qualified practitioner in accordance training and testing program must be the patient’s home, as identified in the with applicable State health and safety reviewed and updated at least every 2 discharge plan. laws, standards of practice, and ASC years. (3) If the RNHCI’s patient assessment policy. (1) * * * does not indicate a need for a discharge (3) The pre-surgical assessment must plan, the beneficiary or his or her legal (ii) Provide emergency preparedness training at least every 2 years. include documentation of any allergies representative may request a discharge to drugs and biologicals. plan. In this case, the RNHCI must * * * * * (4) The patient’s medical history and develop a discharge plan for the (v) If the emergency preparedness physical examination (if any) must be beneficiary. policies and procedures are significantly placed in the patient’s medical record * * * * * updated, the RNHCI must conduct prior to the surgical procedure. ■ 3. Section 403.748 is amended by— training on the updated policies and procedures. * * * * * ■ a. Revising paragraphs (a) ■ 8. Section 416.54 is amended by— introductory text, (a)(4), (b) introductory * * * * * ■ a. Revising paragraphs (a) text, (c) introductory text, (d) PART 416—AMBULATORY SURGICAL introductory text, (a)(4), (b) introductory introductory text, and (d)(1)(ii); and SERVICES text, (c) introductory text, (d) ■ b. Adding paragraph (d)(1)(v). introductory text, and (d)(1)(ii); The revisions and addition read as ■ 4. The authority citation for part 416 ■ b. Adding paragraph (d)(1)(v); and follows: continues to read as follows: ■ c. Revising paragraph (d)(2).

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The revisions and addition read as community-based exercise is not (e) * * * follows: accessible, individual, a facility-based (2) * * * functional exercise every 2 years. If the (i) Safe use and disposal of controlled § 416.54 Condition for coverage— ASC experiences an actual natural or drugs in the patient’s home. The Emergency preparedness. man-made emergency that requires hospice must have written policies and * * * * * activation of the emergency plan, the procedures for the management, use, (a) Emergency plan. The ASC must ASC is exempt from engaging in its next storage, and disposal of controlled drugs develop and maintain an emergency required community-based or in the patient’s home. At the time when preparedness plan that must be individual, facility-based functional controlled drugs are first ordered the reviewed, and updated at least every 2 exercise following the onset of the hospice must: years. The plan must do the following: actual event. (A) Provide information regarding the * * * * * (ii) Conduct an additional exercise at use, storage, and disposal of controlled (4) Include a process for cooperation least every 2 years, opposite the year the drugs to the patient or patient and collaboration with local, tribal, full-scale or functional exercise under representative and family in a format regional, State, and Federal emergency paragraph (d)(2)(i) of this section is that is available on a continual basis; preparedness officials’ efforts to conducted, that may include, but is not (B) Discuss the information regarding maintain an integrated response during limited to the following: the safe use, storage and disposal of a disaster or emergency situation. (A) A second full-scale exercise that is controlled drugs with the patient or (b) Policies and procedures. The ASC community-based, or an individual, representative, and the family, in a must develop and implement facility-based functional exercise; or language and manner that they emergency preparedness policies and (B) A mock disaster drill; or understand to ensure that these parties procedures, based on the emergency (C) A tabletop exercise or workshop are effectively educated; and plan set forth in paragraph (a) of this that includes a group discussion led by (C) Document in the patient’s clinical section, risk assessment at paragraph a facilitator, using a narrated, clinically- record that the information was (a)(1) of this section, and the relevant emergency scenario, and a set provided and discussed. communication plan at paragraph (c) of of problem statements, directed * * * * * this section. The policies and messages, or prepared questions ■ 12. Section 418.112 is amended by procedures must be reviewed and designed to challenge an emergency adding paragraph (c)(10) and removing updated at least every 2 years. At a plan. paragraph (f) to read as follows: (iii) Analyze the ASC’s response to minimum, the policies and procedures § 418.112 Condition of participation: must address the following: and maintain documentation of all Hospices that provide hospice care to * * * * * drills, tabletop exercises, and emergency residents of a SNF/NF or ICF/IID. (c) Communication plan. The ASC events and revise the ASC’s emergency * * * * * must develop and maintain an plan, as needed. (c) * * * emergency preparedness * * * * * (10) A delineation of responsibilities communication plan that complies with for assuring orientation of SNF/NF or PART 418—HOSPICE CARE Federal, State, and local laws and must ICF/IID staff furnishing care to hospice be reviewed and updated at least every ■ 9. The authority citation for part 418 patients, to include information 2 years. The communication plan must continues to read as follows: regarding the hospice philosophy; hospice policies and procedures include all of the following: Authority: Secs. 1102 and 1871 of the * * * * * Social Security Act (42 U.S.C. 1302 and regarding methods of comfort, pain (d) Training and testing. The ASC 1395hh). control, and symptom management; principles about death, dying, and must develop and maintain an ■ 10. Section 418.76 is amended by emergency preparedness training and individual responses to death; patient revising paragraph (a)(1)(iv) to read as rights; appropriate forms; and record testing program that is based on the follows: emergency plan set forth in paragraph keeping requirements. (a) of this section, risk assessment at § 418.76 Condition of participation: * * * * * paragraph (a)(1) of this section, policies Hospice aide and homemaker services. ■ 13. Section 418.113 is amended by— and procedures at paragraph (b) of this * * * * * ■ a. Revising paragraphs (a) section, and the communication plan at (a) * * * introductory text, (a)(4), (b) introductory paragraph (c) of this section. The (1) * * * text, (c) introductory text, (d) training and testing program must be (iv) A State licensure program. introductory text, and (d)(1)(iii); ■ reviewed and updated at least every 2 * * * * * b. Adding paragraph (d)(1)(vi); ■ c. Revising paragraph (d)(2); and years. ■ 11. Section 418.106 is amended by— ■ d. Adding paragraph (d)(3). (1) * * * ■ a. Removing paragraph (a)(1); ■ b. Redesignating paragraph (a)(2) as The revisions and addition to read as (ii) Provide emergency preparedness follows: training at least every 2 years. paragraph (a)(1); ■ c. Adding a new reserved paragraph * * * * * § 418.113 Condition of participation: (a)(2); and Emergency preparedness. (v) If the emergency preparedness ■ d. Revising paragraph (e)(2)(i). policies and procedures are significantly The revision reads as follows: * * * * * updated, the ASC must conduct training (a) Emergency plan. The hospice must on the updated policies and procedures. § 418.106 Condition of participation: Drugs develop and maintain an emergency (2) Testing. The ASC must conduct and biologicals, medical supplies, and preparedness plan that must be exercises to test the emergency plan at durable medical equipment. reviewed, and updated at least every 2 least annually. The ASC must do the * * * * * years. The plan must do the following: following: (a) * * * * * * * * (i) Participate in a full-scale exercise (2) [Reserved] (4) Include a process for cooperation that is community-based or when a * * * * * and collaboration with local, tribal,

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regional, State, or Federal emergency (ii) Conduct an additional exercise at text, (c) introductory text, (d) preparedness officials’ efforts to least every 2 years, opposite the year the introductory text, and (d)(1)(ii); maintain an integrated response during full-scale or functional exercise under ■ b. Adding paragraph (d)(1)(v); and a disaster or emergency situation. paragraph (d)(2)(i) of this section is ■ c. Revising paragraph (d)(2). (b) Policies and procedures. The conducted, that may include, but is not The revisions and addition read as hospice must develop and implement limited to the following: follows: emergency preparedness policies and (A) A second full-scale exercise that is § 441.184 Emergency preparedness. procedures, based on the emergency community-based or an individual, facility-based functional exercise; or * * * * * plan set forth in paragraph (a) of this (a) Emergency plan. The PRTF must section, risk assessment at paragraph (B) A mock disaster drill; or (C) A tabletop exercise or workshop develop and maintain an emergency (a)(1) of this section, and the preparedness plan that must be communication plan at paragraph (c) of that includes a group discussion led by a facilitator, using a narrated, clinically- reviewed, and updated at least every 2 this section. The policies and years. The plan must do the following: procedures must be reviewed and relevant emergency scenario, and a set * * * * * updated at least every 2 years. At a of problem statements, directed messages, or prepared questions (4) Include a process for cooperation minimum, the policies and procedures and collaboration with local, tribal, must address the following: designed to challenge an emergency plan. regional, State, and Federal emergency * * * * * (3) Testing for hospices that provide preparedness officials’ efforts to (c) Communication plan. The hospice inpatient care directly. The hospice maintain an integrated response during must develop and maintain an must conduct exercises to test the a disaster or emergency situation. emergency preparedness emergency plan twice per year. The (b) Policies and procedures. The PRTF communication plan that complies with hospice must do the following: must develop and implement Federal, State, and local laws and must (i) Participate in a full-scale exercise emergency preparedness policies and be reviewed and updated at least every that is community-based or when a procedures, based on the emergency 2 years. The communication plan must community-based exercise is not plan set forth in paragraph (a) of this include all of the following: accessible, an individual, facility-based section, risk assessment at paragraph * * * * * functional exercise annually. If the (a)(1) of this section, and the (d) Training and testing. The hospice hospice experiences an actual natural or communication plan at paragraph (c) of must develop and maintain an man-made emergency that requires this section. The policies and emergency preparedness training and activation of the emergency plan, the procedures must be reviewed and testing program that is based on the hospice is exempt from engaging in its updated at least every 2 years. At a emergency plan set forth in paragraph next required full-scale community- minimum, the policies and procedures (a) of this section, risk assessment at based or individual, facility-based must address the following: paragraph (a)(1) of this section, policies functional exercise following the onset * * * * * and procedures at paragraph (b) of this of the actual event. (c) Communication plan. The PRTF section, and the communication plan at (ii) Conduct an additional exercise at must develop and maintain an paragraph (c) of this section. The least annually that may include, but is emergency preparedness training and testing program must be not limited to the following: communication plan that complies with reviewed and updated at least every 2 (A) A second full-scale exercise that is Federal, State, and local laws and must years. community-based or an individual, be reviewed and updated at least every (1) * * * facility-based functional exercise; or 2 years. The communication plan must include all of the following: (iii) Provide emergency preparedness (B) A mock disaster drill; or (C) A tabletop exercise or workshop training at least every 2 years. * * * * * that includes a group discussion led by (d) Training and testing. The PRTF * * * * * a facilitator, using a narrated, clinically- must develop and maintain an (vi) If the emergency preparedness relevant emergency scenario, and a set emergency preparedness training policies and procedures are significantly of problem statements, directed program that is based on the emergency updated, the hospice must conduct messages, or prepared questions plan set forth in paragraph (a) of this training on the updated policies and designed to challenge an emergency section, risk assessment at paragraph procedures. plan. (a)(1) of this section, policies and (2) Testing for hospices that provide (iii) Analyze the hospice’s response to procedures at paragraph (b) of this care in the patient’s home. The hospice and maintain documentation of all section, and the communication plan at must conduct exercises to test the drills, tabletop exercises, and emergency paragraph (c) of this section. The emergency plan at least annually. The events and revise the hospice’s training and testing program must be hospice must do the following: emergency plan, as needed. reviewed and updated at least every 2 (i) Participate in a full-scale exercise * * * * * years. that is community-based or when a (1) * * * community-based exercise is not PART 441—SERVICES: (ii) After initial training, provide accessible, an individual, facility-based REQUIREMENTS AND LIMITS emergency preparedness training every functional exercise every 2 years. If the APPLICABLE TO SPECIFIC SERVICES 2 years. hospice experiences an actual natural or ■ 14. The authority citation for part 441 * * * * * man-made emergency that requires (v) If the emergency preparedness continues to read as follows: activation of the emergency plan, the policies and procedures are significantly hospital is exempt from engaging in its Authority: Secs. 1102, 1902, and 1928 of updated, the PRTF must conduct next required full-scale community- the Social Security Act (42 U.S.C. 1302). training on the updated policies and based or individual, facility-based ■ 15. Section 441.184 is amended by— procedures. functional exercise following the onset ■ a. Revising paragraphs (a) (2) Testing. The PRTF must conduct of the actual event. introductory text, (a)(4), (b) introductory exercises to test the emergency plan

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twice per year. The PRTF must do the maintain an integrated response during PACE is exempt from engaging in its following: a disaster or emergency situation. next required full-scale community- (i) Participate in a full-scale exercise (b) Policies and procedures. The based or individual, facility-based annually that is community-based or PACE organization must develop and functional exercise following the onset when a community-based exercise is not implement emergency preparedness of the actual event. accessible, an individual, facility-based policies and procedures, based on the (ii) Conduct an additional exercise at functional exercise annually. If the emergency plan set forth in paragraph least every 2 years opposite the year the PRTF experiences an actual natural or (a) of this section, risk assessment at full-scale or functional exercise under man-made emergency that requires paragraph (a)(1) of this section, and the paragraph (d)(2)(i) of this section is activation of the emergency plan, the communication plan at paragraph (c) of conducted that may include, but is not PRTF is exempt from engaging in its this section. The policies and limited to the following: next required full-scale community- procedures must address management (A) A second full-scale exercise that is based or individual, facility-based of medical and nonmedical community-based or an individual, functional exercise following the onset emergencies, including, but not limited facility-based functional exercise; or of the actual event. to: Fire; equipment, power, or water (B) A mock disaster drill; or (ii) Conduct an additional exercise at failure; care-related emergencies; and (C) A tabletop exercise or workshop least annually that may include, but is natural disasters likely to threaten the that includes a group discussion led by not limited to the following: health or safety of the participants, staff, a facilitator, using a narrated, clinically- (A) A second full-scale exercise that is or the public. Policies and procedures relevant emergency scenario, and a set community-based or individual, a must be reviewed and updated at least of problem statements, directed facility-based functional exercise; or every 2 years. At a minimum, the messages, or prepared questions (B) A mock disaster drill; or policies and procedures must address designed to challenge an emergency (C) A tabletop exercise or workshop the following: plan. that includes a group discussion led by (iii) Analyze the PACE’s response to * * * * * a facilitator, using a narrated, clinically- (c) Communication plan. The PACE and maintain documentation of all relevant emergency scenario, and a set organization must develop and maintain drills, tabletop exercises, and emergency of problem statements, directed an emergency preparedness events and revise the PACE’s emergency messages, or prepared questions communication plan that complies with plan, as needed. designed to challenge an emergency Federal, State, and local laws and must * * * * * plan. be reviewed and updated at least every (iii) Analyze the PRTF’s response to 2 years. The communication plan must PART 482—CONDITIONS OF and maintain documentation of all include all of the following: PARTICIPATION FOR HOSPITALS drills, tabletop exercises, and emergency ■ events and revise the PRTF’s emergency * * * * * 18. The authority citation for part 482 plan, as needed. (d) Training and testing. The PACE continues to read as follows: organization must develop and maintain * * * * * Authority: Secs. 1102, 1871, and 1881 of an emergency preparedness training and the Social Security Act (42 U.S.C. 1302, PART 460—PROGRAMS OF ALL- testing program that is based on the 1395hh, and 1395rr), unless otherwise noted. emergency plan set forth in paragraph INCLUSIVE CARE FOR THE ELDERLY ■ 19. Section 482.15 is amended— (PACE) (a) of this section, risk assessment at ■ a. By revising paragraphs (a) paragraph (a)(1) of this section, policies introductory text, (a)(4), (b) introductory ■ 16. The authority citation for part 460 and procedures at paragraph (b) of this text, (c) introductory text, (d) continues to read as follows: section, and the communication plan at introductory text, and (d)(1)(ii); Authority: Secs: 1102, 1871, 1894(f), and paragraph (c) of this section. The ■ b. By adding paragraph (d)(1)(v); 1934(f) of the Social Security Act (42 U.S.C. training and testing program must be ■ c. By revising paragraph (d)(2); 1302, 1395, 1395eee(f), and 1396u–4(f)). reviewed and updated at lease every 2 ■ d. In paragraph (g) introductory text, ■ 17. Section 460.84 is amended by— years. by removing the phrase ‘‘transplant ■ a. Revising paragraphs (a) (1) * * * centers’’ and adding into its place the introductory text, (a)(4), (b) introductory (ii) Provide emergency preparedness phrase ‘‘transplant programs’’; and text, (c) introductory text, (d) training at least every 2 years. ■ e. In paragraphs (g)(1) and (2), by introductory text, and (d)(1)(ii); * * * * * removing the phrase ‘‘transplant center’’ ■ b. Adding paragraph (d)(1)(v); and (v) If the emergency preparedness and adding into its place the phrase ■ c. Revising paragraph (d)(2). policies and procedures are significantly ‘‘transplant program’’. The revisions and addition read as updated, the PACE must conduct The revisions and addition read as follows: training on the updated policies and follows: procedures. § 460.84 Emergency preparedness. (2) Testing. The PACE organization § 482.15 Condition of participation: * * * * * must conduct exercises to test the Emergency preparedness. (a) Emergency plan. The PACE emergency plan at least annually. The * * * * * organization must develop and maintain PACE organization must do the (a) Emergency plan. The hospital an emergency preparedness plan that following: must develop and maintain an must be reviewed, and updated at least (i) Participate in a full-scale exercise emergency preparedness plan that must every 2 years. The plan must do the that is community-based or when a be reviewed, and updated at least every following: community-based exercise is not 2 years. The plan must do the following: * * * * * accessible, an individual, facility-based * * * * * (4) Include a process for cooperation functional exercise every 2 years. If the (4) Include a process for cooperation and collaboration with local, tribal, PACE experiences an actual natural or and collaboration with local, tribal, regional, State, and Federal emergency man-made emergency that requires regional, State, and Federal emergency preparedness officials’ efforts to activation of the emergency plan, the preparedness officials’ efforts to

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maintain an integrated response during (A) A second full-scale exercise that is The revisions and additions read as a disaster or emergency situation. community-based or an individual, follows: (b) Policies and procedures. The facility-based functional exercise; or (B) A mock disaster drill; or § 482.22 Condition of participation: hospital must develop and implement Medical staff. emergency preparedness policies and (C) A tabletop exercise or workshop procedures, based on the emergency that includes a group discussion led by * * * * * plan set forth in paragraph (a) of this a facilitator, using a narrated, clinically- (c) * * * section, risk assessment at paragraph relevant emergency scenario, and a set (5) * * * (a)(1) of this section, and the of problem statements, directed (i) A medical history and physical communication plan at paragraph (c) of messages, or prepared questions examination be completed and this section. The policies and designed to challenge an emergency documented for each patient no more procedures must be reviewed and plan. than 30 days before or 24 hours after updated at least every 2 years. At a (iii) Analyze the hospital’s response to admission or registration, but prior to minimum, the policies and procedures and maintain documentation of all surgery or a procedure requiring must address the following: drills, tabletop exercises, and emergency anesthesia services, and except as events, and revise the hospital’s * * * * * provided under paragraph (c)(5)(iii) of emergency plan, as needed. (c) Communication plan. The hospital this section. The medical history and must develop and maintain an * * * * * physical examination must be ■ emergency preparedness 20. Section 482.21 is amended by completed and documented by a communication plan that complies with adding paragraph (f) to read as follows: physician (as defined in section 1861(r) Federal, State, and local laws and must of the Act), an oromaxillofacial surgeon, § 482.21 Condition of participation: Quality or other qualified licensed individual in be reviewed and updated at least every assessment and performance improvement 2 years. The communication plan must program. accordance with State law and hospital policy. include all of the following: * * * * * * * * * * (f) Standard: Unified and integrated (ii) An updated examination of the patient, including any changes in the (d) Training and testing. The hospital QAPI program for multi-hospital patient’s condition, be completed and must develop and maintain an systems. If a hospital is part of a hospital documented within 24 hours after emergency preparedness training and system consisting of multiple separately admission or registration, but prior to testing program that is based on the certified hospitals using a system surgery or a procedure requiring emergency plan set forth in paragraph governing body that is legally anesthesia services, when the medical (a) of this section, risk assessment at responsible for the conduct of two or history and physical examination are paragraph (a)(1) of this section, policies more hospitals, the system governing completed within 30 days before and procedures at paragraph (b) of this body can elect to have a unified and admission or registration, and except as section, and the communication plan at integrated QAPI program for all of its provided under paragraph (c)(5)(iii) of paragraph (c) of this section. The member hospitals after determining that this section. The updated examination training and testing program must be such a decision is in accordance with all of the patient, including any changes in reviewed and updated at least every 2 applicable State and local laws. The the patient’s condition, must be years. system governing body is responsible and accountable for ensuring that each completed and documented by a (1) * * * physician (as defined in section 1861(r) (ii) Provide emergency preparedness of its separately certified hospitals meets all of the requirements of this of the Act), an oromaxillofacial surgeon, training at least every 2 years. or other qualified licensed individual in * * * * * section. Each separately certified hospital subject to the system governing accordance with State law and hospital (v) If the emergency preparedness body must demonstrate that: policy. policies and procedures are significantly (1) The unified and integrated QAPI (iii) An assessment of the patient (in updated, the hospital must conduct program is established in a manner that lieu of the requirements of paragraphs training on the updated policies and takes into account each member (c)(5)(i) and (ii) of this section) be procedures. hospital’s unique circumstances and completed and documented after (2) Testing. The hospital must any significant differences in patient registration, but prior to surgery or a conduct exercises to test the emergency populations and services offered in each procedure requiring anesthesia services, plan at least twice per year. The hospital hospital; and when the patient is receiving specific must do all of the following: (2) The unified and integrated QAPI outpatient surgical or procedural (i) Participate in an annual full-scale program establishes and implements services and when the medical staff has exercise that is community-based or policies and procedures to ensure that chosen to develop and maintain a policy when a community-based exercise is not the needs and concerns of each of its that identifies, in accordance with the accessible, an individual, facility-based separately certified hospitals, regardless requirements at paragraph (c)(5)(v) of functional exercise annually. If the of practice or location, are given due this section, specific patients as not hospital experiences an actual natural or consideration, and that the unified and requiring a comprehensive medical man-made emergency that requires integrated QAPI program has history and physical examination, or activation of the emergency plan, the mechanisms in place to ensure that any update to it, prior to specific hospital is exempt from engaging in its issues localized to particular hospitals outpatient surgical or procedural next required full-scale community- are duly considered and addressed. services. The assessment must be based exercise or individual, facility- ■ 21. Section 482.22 is amended by— completed and documented by a based functional exercise following the ■ a. Revising paragraphs (c)(5)(i) and physician (as defined in section 1861(r) onset of the actual event. (ii); of the Act), an oromaxillofacial surgeon, (ii) Conduct an additional exercise at ■ b. Adding paragraphs (c)(5)(iii), (iv), or other qualified licensed individual in least annually that may include, but is and (v); and accordance with State law and hospital not limited to the following: ■ c. Removing paragraph (d). policy.

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(iv) The medical staff develop and the patient’s medical record within 24 (4) A qualified individual (or maintain a policy that identifies those hours after admission or registration, individuals) with expertise in infection patients for whom the assessment but prior to surgery or a procedure prevention and control has been requirements of paragraph (c)(5)(iii) of requiring anesthesia services. designated at the hospital as responsible this section would apply. The (C) An assessment of the patient (in for communicating with the unified provisions of paragraphs (c)(5)(iii), (iv), lieu of the requirements of paragraphs infection control program, for and (v) of this section do not apply to (c)(4)(i)(A) and (B) of this section) implementing and maintaining the a medical staff that chooses to maintain completed and documented after policies and procedures governing a policy that adheres to the registration, but prior to surgery or a infection control as directed by the requirements of paragraphs of (c)(5)(i) procedure requiring anesthesia services, unified infection control program, and and (ii) of this section for all patients. when the patient is receiving specific for providing infection prevention (v) The medical staff, if it chooses to outpatient surgical or procedural education and training to hospital staff. develop and maintain a policy for the services and when the medical staff has ■ 24. Section 482.51 is amended by identification of specific patients to chosen to develop and maintain a policy revising paragraphs (b)(1)(i) and (ii) and whom the assessment requirements in that identifies, in accordance with the adding paragraph (b)(1)(iii) to read as paragraph (c)(5)(iii) of this section requirements at § 482.22(c)(5)(v), follows: would apply, must demonstrate specific patients as not requiring a § 482.51 Condition of participation: evidence that the policy applies only to comprehensive medical history and Surgical services. those patients receiving specific physical examination, or any update to * * * * * outpatient surgical or procedural it, prior to specific outpatient surgical or (b) * * * services as well as evidence that the procedural services. (1) * * * policy is based on: * * * * * (i) A medical history and physical (A) Patient age, diagnoses, the type ■ 23. Section 482.42 is amended by examination must be completed and and number of surgeries and procedures adding paragraph (c) to read as follows: documented no more than 30 days scheduled to be performed, before or 24 hours after admission or comorbidities, and the level of § 482.42 Condition of participation: registration, and except as provided anesthesia required for the surgery or Infection control. under paragraph (b)(1)(iii) of this procedure. * * * * * section. (B) Nationally recognized guidelines (c) Standard: Unified and integrated (ii) An updated examination of the and standards of practice for assessment infection control program for multi- patient, including any changes in the of specific types of patients prior to hospital systems. If a hospital is part of patient’s condition, must be completed specific outpatient surgeries and a hospital system consisting of multiple and documented within 24 hours after procedures. separately certified hospitals using a admission or registration when the (C) Applicable state and local health system governing body that is legally medical history and physical and safety laws. responsible for the conduct of two or examination are completed within 30 * * * * * more hospitals, the system governing days before admission or registration, ■ 22. Section 482.24 is amended by body can elect to have a unified and and except as provided under paragraph revising paragraphs (c)(4)(i)(A) and (B) integrated infection control program for (b)(1)(iii) of this section. and adding paragraph (c)(4)(i)(C) to read all of its member hospitals after (iii) An assessment of the patient must as follows: determining that such a decision is in be completed and documented after registration (in lieu of the requirements § 482.24 Condition of participation: accordance with all applicable State and Medical record services. local laws. The system governing body of paragraphs (b)(1)(i) and (ii) of this is responsible and accountable for section) when the patient is receiving * * * * * specific outpatient surgical or (c) * * * ensuring that each of its separately procedural services and when the (4) * * * certified hospitals meets all of the (i) * * * requirements of this section. Each medical staff has chosen to develop and (A) A medical history and physical separately certified hospital subject to maintain a policy that identifies, in examination completed and the system governing body must accordance with the requirements at documented no more than 30 days demonstrate that: § 482.22(c)(5)(v), specific patients as not before or 24 hours after admission or (1) The unified and integrated requiring a comprehensive medical registration, but prior to surgery or a infection control program is established history and physical examination, or procedure requiring anesthesia services, in a manner that takes into account each any update to it, prior to specific and except as provided under paragraph member hospital’s unique outpatient surgical or procedural (c)(4)(i)(C) of this section. The medical circumstances and any significant services. history and physical examination must differences in patient populations and * * * * * be placed in the patient’s medical services offered in each hospital; ■ 25. Section 482.58 is amended by— record within 24 hours after admission (2) The unified and integrated ■ a. Revising paragraph (b)(1); ■ or registration, but prior to surgery or a infection control program establishes b. Removing paragraph (b)(4); ■ c. Redesignating paragraphs (b)(5) procedure requiring anesthesia services. and implements policies and (B) An updated examination of the procedures to ensure that the needs and through (8) as paragraphs (b)(4) through patient, including any changes in the concerns of each of its separately (7); and ■ d. Revising newly redesignated patient’s condition, when the medical certified hospitals, regardless of practice or location, are given due consideration; paragraphs (b)(4) and (7). history and physical examination are The revisions read as follows: completed within 30 days before (3) The unified and integrated admission or registration, and except as infection control program has § 482.58 Special requirements for hospital provided under paragraph (c)(4)(i)(C) of mechanisms in place to ensure that providers of long-term care services this section. Documentation of the issues localized to particular hospitals (‘‘swing-beds’’). updated examination must be placed in are duly considered and addressed; and * * * * *

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(b) * * * progress in accordance with the original § 482.70 Definitions. (1) Resident rights (§ 483.10(b)(7), or revised treatment plan. * * * * * (c)(1), (c)(2)(iii), (c)(6), (d), (e)(2) and (4), * * * * * Heart-Lung transplant program means (f)(4)(ii) and (iii), (h), (g)(8) and (17), and a transplant program that is located in § 482.68 [Amended] (g)(18) introductory text of this chapter). a hospital with an existing Medicare- * * * * * ■ 27. Section 482.68 is amended— approved heart transplant program and (4) Social services (§ 483.40(d) of this ■ a. In the section heading by removing an existing Medicare-approved lung chapter). the phrase ‘‘transplant centers’’ and program that performs combined heart- * * * * * adding in its place the phrase lung transplants. (7) Dental services (§ 483.55(a)(2), (3), ‘‘transplant programs’’; and Intestine transplant program means a ■ (4), and (5) and (b) of this chapter). b. In the introductory text and in Medicare-approved liver transplant ■ 26. Section 482.61 is amended by paragraph (b) by removing the phrase program that performs intestine revising paragraph (d) to read as ‘‘transplant center’’ and adding in its transplants, combined liver-intestine follows: place the phrase ‘‘transplant program’’. transplants, or multivisceral transplants. ■ 28. Section 482.70 is amended— § 482.61 Condition of participation: ■ a. In the definition of ‘‘Adverse event’’ * * * * * Special medical record requirements for by removing the phrase ‘‘transplant Pancreas transplant program means a psychiatric hospitals. centers’’ and adding in its place the Medicare-approved kidney transplant * * * * * phrase ‘‘transplant programs’’; program that performs pancreas (d) Standard: Recording progress. ■ b. By removing the definitions of transplants alone or subsequent to a Progress notes must be recorded by the ‘‘Heart-Lung transplant center’’ and kidney transplant as well as kidney- physician(s), psychologists, or other ‘‘Intestine transplant center’’; pancreas transplants. licensed independent practitioner(s) ■ c. By adding the definitions of ‘‘Heart- * * * * * responsible for the care of the patient as Lung transplant program’’ and Transplant program means an organ- specified in § 482.12(c), nurse, social ‘‘Intestine transplant program’’ in specific transplant program within a worker and, when appropriate, others alphabetical order; transplant hospital (as defined in this significantly involved in active ■ d. By removing the definitions of section). treatment modalities. The frequency of ‘‘Pancreas transplant center’’ and progress notes is determined by the ‘‘Transplant center’’; §§ 482.72, 482.74, 482.78, and 482.80 condition of the patient but must be ■ e. By adding the definition of [Amended] recorded at least weekly for the first 2 ‘‘Pancreas transplant program’’ in ■ 29. In the following table, for each months and at least once a month alphabetical order; and section and paragraph indicated in the thereafter and must contain ■ f. By revising the definition of first two columns, remove the phrase recommendations for revisions in the ‘‘Transplant program’’. indicated in the third column each time treatment plan as indicated as well as The additions and revision read as it appears and add the reference precise assessment of the patient’s follows: indicated in the fourth column:

Section Paragraphs Remove Add

§ 482.72 ...... transplant center ...... transplant program. § 482.74 ...... (a) introductory text ...... transplant center ...... transplant program. § 482.74 ...... (a) introductory text ...... center’s ...... hospital’s. § 482.74 ...... (a)(1) ...... transplant center ...... transplant program. § 482.74 ...... (a)(1) ...... center’s ...... program’s. § 482.74 ...... (a)(2) ...... transplant center ...... transplant program. § 482.74 ...... (a)(3) ...... transplant center ...... transplant program. § 482.74 ...... (b) introductory text ...... transplant center ...... transplant program. § 482.78 ...... Section heading ...... transplant centers ...... transplant programs. § 482.78 ...... Introductory text ...... transplant center ...... transplant program. § 482.78 ...... (a) ...... transplant center ...... transplant program. § 482.78 ...... (b) ...... transplant center ...... transplant program. § 482.80 ...... Section heading ...... transplant centers ...... transplant programs. § 482.80 ...... Introductory text ...... transplant centers ...... transplant programs. § 482.80 ...... (a) ...... transplant center ...... transplant program. § 482.80 ...... (a) ...... beneficiary ...... recipient. § 482.80 ...... (b) ...... transplant center ...... transplant program. § 482.80 ...... (c) introductory text ...... center ...... program. § 482.80 ...... (c)(1) ...... transplant center’s ...... transplant program’s. § 482.80 ...... (c)(1) ...... center-specific report ...... program-specific report. § 482.80 ...... (c)(1) ...... Beneficiaries ...... Recipients. § 482.80 ...... (c)(2) ...... center’s ...... program’s. § 482.80 ...... (d)(1) ...... transplant center ...... transplant program. § 482.80 ...... (d)(2) ...... transplant center ...... transplant program. § 482.80 ...... (d)(3) ...... transplant center ...... transplant program. § 482.80 ...... (d)(4) ...... transplant center ...... transplant program. § 482.80 ...... (d)(5) ...... transplant center ...... transplant program.

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§ 482.82 [Removed] §§ 482.90, 482.92, 482.94, 482.96, 482.98, first two columns, remove the phrase 482.100, and 482.102 [Amended] ■ 30. Section 482.82 is removed. indicated in the third column each time ■ 31. In the following table, for each it appears and add the reference section and paragraph indicated in the indicated in the fourth column:

Section Paragraphs Remove Add

§ 482.90 ...... Introductory text ...... transplant center ...... transplant program. § 482.90 ...... Introductory text ...... center ...... program. § 482.90 ...... (a)(2) ...... transplant center ...... transplant program. § 482.90 ...... (a)(4) ...... transplant center ...... transplant program. § 482.90 ...... (b) introductory text ...... Transplant centers ...... Transplant programs. § 482.92 ...... Introductory text ...... donor-beneficiary ...... donor-recipient. § 482.92 ...... Introductory text ...... beneficiary ...... recipient. § 482.92 ...... Introductory text ...... Transplant centers ...... Transplant programs. § 482.92 ...... Introductory text ...... transplant center ...... transplant program. § 482.92 ...... (a) ...... transplant center ...... transplant program. § 482.92 ...... (a) ...... beneficiary ...... recipient. § 482.92 ...... (b) ...... beneficiary ...... recipient. § 482.92 ...... (b) ...... beneficiary’s ...... recipient’s. § 482.94 ...... Introductory text ...... Transplant centers ...... Transplant programs. § 482.94 ...... Introductory text ...... transplant center ...... transplant programs. § 482.94 ...... Introductory text ...... the center also ...... the program also. § 482.94 ...... (a) introductory text ...... transplant center’s ...... transplant program’s. § 482.94 ...... (a)(2) ...... center ...... program. § 482.94 ...... (b) introductory text ...... Transplant centers ...... Transplant programs. § 482.94 ...... (b)(2) ...... center’s ...... program’s. § 482.94 ...... (b)(3) ...... center’s ...... program’s. § 482.94 ...... (c) introductory text ...... Transplant centers ...... Transplant programs. § 482.94 ...... (c) introductory text ...... center’s waiting list ...... program’s waiting list. § 482.94 ...... (c)(2) ...... transplant center ...... transplant program. § 482.94 ...... (c)(3) introductory text ...... transplant centers ...... transplant programs. § 482.94 ...... (d) introductory text ...... transplant center ...... transplant program. § 482.94 ...... (d)(2) ...... transplant center ...... transplant program. § 482.94 ...... (e) ...... Transplant centers ...... Transplant programs. § 482.96 ...... Introductory text ...... Transplant centers ...... Transplant programs. § 482.96 ...... (a) ...... transplant center’s ...... transplant program’s. § 482.96 ...... (a) ...... beneficiary ...... recipient. § 482.96 ...... (a) ...... transplant center ...... transplant program. § 482.96 ...... (b) introductory text ...... transplant center ...... transplant program. § 482.96 ...... (b)(2) ...... transplant center ...... transplant program. § 482.96 ...... (b)(2) ...... transplant center’s ...... transplant program’s. § 482.98 ...... Introductory text ...... transplant center ...... transplant program. § 482.98 ...... Introductory text ...... the center ...... the program. § 482.98 ...... (a) (a) heading and introductory text ... transplant center ...... transplant program. § 482.98 ...... (a)(1) ...... transplant center ...... transplant program. § 482.98 ...... (b) introductory text ...... transplant center ...... transplant program. § 482.98 ...... (c) introductory text ...... transplant center ...... transplant program. § 482.98 ...... (c)(2) ...... transplant center ...... transplant program. § 482.98 ...... (d) introductory text ...... transplant center ...... transplant program. § 482.98 ...... (d) heading ...... living donor advocate team ...... independent living donor advocate team. § 482.98 ...... (d)(1) ...... living donor advocate ...... independent living donor advocate. § 482.98 ...... (d)(2) introductory text ...... living donor advocate team ...... independent living donor advocate team. § 482.98 ...... (d)(3) introductory text ...... living donor advocate team ...... independent living donor advocate team. § 482.98 ...... (e) ...... transplant center ...... transplant program. § 482.98 ...... (f) ...... transplant center ...... transplant program. § 482.100 ...... transplant center ...... transplant program. § 482.102 ...... Introductory text ...... transplant center ...... transplant program. § 482.102 ...... (a) introductory text ...... Transplant centers ...... Transplant programs. § 482.102 ...... (a)(8) ...... transplant center ...... transplant program. § 482.102 ...... (a)(8) ...... beneficiary’s ...... recipient’s. § 482.102 ...... (b) introductory text ...... Transplant centers ...... Transplant programs. § 482.102 ...... (b)(1) ...... transplant center ...... transplant program. § 482.102 ...... (b)(4) ...... beneficiary ...... recipient. § 482.102 ...... (b)(6) ...... transplant center-specific ...... transplant program-specific. § 482.102 ...... (b)(6) ...... beneficiaries ...... receipients. § 482.102 ...... (b)(6) ...... center-specific outcomes ...... transplant-specific outcomes. § 482.102 ...... (b)(9) ...... transplant center ...... transplant program. § 482.102 ...... (b)(9) ...... beneficiary’s ...... recipient’s. § 482.102 ...... (c) introductory text ...... Transplant centers ...... Transplant programs. § 482.102 ...... (c) introductory text ...... center’s ...... program’s. § 482.102 ...... (c) introductory text ...... center ...... program. § 482.102 ...... (c)(1) introductory text ...... transplant center ...... transplant program.

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Section Paragraphs Remove Add

§ 482.102 ...... (c)(1) introductory text ...... center’s waiting list ...... program’s waiting list. § 482.102 ...... (c)(2)(i) ...... center’s waiting list ...... program’s waiting list. § 482.102 ...... (c)(2)(i) ...... transplant center ...... transplant program. § 482.102 ...... (c)(2)(ii) ...... beneficiaries ...... recipients. § 482.102 ...... (c)(2)(ii) ...... center’s waiting list ...... program’s waiting list. § 482.102 ...... (c)(2)(ii) ...... the center ...... the program. § 482.102 ...... (c)(2)(ii) ...... center’s termination of approval ...... program’s termination of approval. § 482.102 ...... (c)(3) ...... transplant center’s ...... transplant program’s. § 482.102 ...... (c)(3) ...... the center ...... the program. § 482.102 ...... (c)(3) ...... center’s waiting list ...... program’s waiting list. § 482.102 ...... (c)(3) ...... transplant center ...... transplant program.

■ 32. Section 482.102 is further (5) National and transplant program- § 482.104 [Amended] amended by revising paragraph (a)(5) to specific outcomes, from the most recent ■ 33. For § 482.104, in the following read as follows: SRTR program-specific report, including table, for the heading and each (but not limited to) the transplant paragraph indicated in the first column, § 482.102 Condition of participation: program’s observed and expected 1-year Patient and living donor rights. remove the phrase indicated in the patient and graft survival, and national second column each time it appears and * * * * * 1-year patient and graft survival; add the reference indicated in the third (a) * * * * * * * * column:

Paragraphs Remove Add

Section heading ...... transplant centers ...... transplant programs. (a) ...... transplant centers ...... transplant programs. (a) ...... transplant center ...... transplant program. (b) ...... transplant centers ...... transplant programs. (c) ...... transplant centers ...... transplant programs.

PART 483—REQUIREMENTS FOR emergency preparedness policies and (ii) Provide emergency preparedness STATES AND LONG TERM CARE procedures, based on the emergency training at least every 2 years. FACILITIES plan set forth in paragraph (a) of this * * * * * section, risk assessment at paragraph ■ (v) If the emergency preparedness 34. The authority citation for part 483 (a)(1) of this section, and the continues to read as follows: policies and procedures are significantly communication plan at paragraph (c) of updated, the LTC facility must conduct Authority: Secs. 1102, 1128I, 1819, 1871 this section. The policies and training on the updated policies and and 1919 of the Social Security Act (42 procedures must be reviewed and procedures. U.S.C. 1302, 1320a–7, 1395i, 1395hh and updated at least every 2 years. At a 1396r). (2) Testing. The LTC facility must minimum, the policies and procedures conduct exercises to test the emergency ■ 35. Section 483.73 is amended by— must address the following: ■ plan at least twice per year, including a. Revising paragraphs (a) * * * * * unannounced staff drills using the introductory text, (a)(4), (b) introductory emergency procedures. The LTC facility text, (c) introductory text, (d) (c) Communication plan. The LTC facility must develop and maintain an must do the following: introductory text, and (d)(1)(ii); (i) Participate in an annual full-scale ■ b. Adding paragraph (d)(1)(v); and emergency preparedness ■ c. Revising paragraph (d)(2). communication plan that complies with exercise that is community-based or The revisions and addition read as Federal, State, and local laws and must when a community-based exercise is not follows: be reviewed and updated at least every accessible, an individual, facility-based 2 years. The communication plan must functional exercise annually. If the LTC § 483.73 Emergency preparedness. include all of the following: facility experiences an actual natural or man-made emergency that requires * * * * * * * * * * (a) Emergency plan. The LTC facility activation of the emergency plan, the must develop and maintain an (d) Training and testing. The LTC LTC facility is exempt from engaging its emergency preparedness plan that must facility must develop and maintain an next required a full-scale community- be reviewed, and updated at least every emergency preparedness training and based or individual, facility-based 2 years. The plan must do all of the testing program that is based on the functional exercise following the onset following: emergency plan set forth in paragraph of the actual event. * * * * * (a) of this section, risk assessment at (ii) Conduct an additional exercise at (4) Include a process for cooperation paragraph (a)(1) of this section, policies least annually that may include, but is and collaboration with local, tribal, and procedures at paragraph (b) of this not limited to the following: regional, State, or Federal emergency section, and the communication plan at (A) A second full-scale exercise that is preparedness officials’ efforts to paragraph (c) of this section. The community-based or an individual, maintain an integrated response during training and testing program must be facility-based functional exercise; or a disaster or emergency situation. reviewed and updated at least every 2 (B) A mock disaster drill; or (b) Policies and procedures. The LTC years. (C) A tabletop exercise or workshop facility must develop and implement (1) * * * that includes a group discussion led by

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a facilitator, using a narrated, clinically- paragraph (a)(1) of this section, policies § 484.50 Condition of participation: Patient relevant emergency scenario, and a set and procedures at paragraph (b) of this rights. of problem statements, directed section, and the communication plan at * * * * * messages, or prepared questions paragraph (c) of this section. The (c) * * * designed to challenge an emergency training and testing program must be (7) Be advised, orally and in writing, plan. reviewed and updated at least every 2 of— (iii) Analyze the LTC facility’s years. The ICF/IID must meet the * * * * * response to and maintain requirements for evacuation drills and ■ 39. Section 484.80 is amended by documentation of all drills, tabletop training at § 483.470(i). revising paragraph (h)(3) to read as exercises, and emergency events, and (1) * * * follows: revise the LTC facility’s emergency (ii) Provide emergency preparedness plan, as needed. training at least every 2 years. § 484.80 Condition of participation: Home health aide services. * * * * * * * * * * * * * * * ■ 36. Section 483.475 is amended by— (v) If the emergency preparedness ■ (h) * * * a. Revising paragraphs (a) policies and procedures are significantly (3) If a deficiency in aide services is introductory text, (a)(4), (b) introductory updated, the ICF/IID must conduct verified by the registered nurse or other text, (c) introductory text, (d) training on the updated policies and appropriate skilled professional during introductory text, and (d)(1)(ii); procedures. an on-site visit, then the agency must ■ b. Adding paragraph (d)(1)(v); and (2) Testing. The ICF/IID must conduct conduct, and the home health aide must ■ c. Revising paragraph (d)(2). exercises to test the emergency plan at complete, retraining and a competency The revisions and addition read as least twice per year. The ICF/IID must evaluation related to the deficient follows: do the following: skill(s). (i) Participate in an annual full-scale § 483.475 Condition of participation: exercise that is community-based or * * * * * Emergency preparedness. ■ 40. Section 484.102 is amended by— when a community-based exercise is not ■ a. Revising paragraphs (a) * * * * * accessible, an individual, facility-based (a) Emergency plan. The ICF/IID must introductory text, (a)(4), (b) introductory functional exercise annually. If the ICF/ develop and maintain an emergency text, (c) introductory text, and (d) IID experiences an actual natural or preparedness plan that must be introductory text and the first paragraph man-made emergency that requires reviewed, and updated at least every 2 (d)(1)(ii); activation of the emergency plan, the years The plan must do all of the ■ b. Redesignating the second paragraph ICF/IID is exempt from engaging in its following: (d)(1)(ii) as paragraph (d)(1)(iv); next required full-scale community- ■ * * * * * c. Adding paragraph (d)(1)(v); and based or individual, facility-based ■ d. Revising paragraph (d)(2). (4) Include a process for cooperation functional exercise following the onset The revisions and addition read as and collaboration with local, tribal, of the actual event. follows: regional, State, and Federal emergency (ii) Conduct an additional exercise at preparedness officials’ efforts to least annually that may include, but is § 484.102 Condition of participation: maintain an integrated response during not limited to the following: Emergency preparedness. a disaster or emergency situation. (A) A second full-scale exercise that is * * * * * (b) Policies and procedures. The ICF/ community-based or an individual, (a) Emergency plan. The HHA must IID must develop and implement facility-based functional exercise; or develop and maintain an emergency emergency preparedness policies and (B) A mock disaster drill; or preparedness plan that must be procedures, based on the emergency (C) A tabletop exercise or workshop reviewed, and updated at least every 2 plan set forth in paragraph (a) of this that includes a group discussion led by years. The plan must do all of the section, risk assessment at paragraph a facilitator, using a narrated, clinically- following: (a)(1) of this section, and the relevant emergency scenario, and a set * * * * * communication plan at paragraph (c) of of problem statements, directed (4) Include a process for cooperation this section. The policies and messages, or prepared questions and collaboration with local, tribal, procedures must be reviewed and designed to challenge an emergency regional, State, and Federal emergency updated at least every 2 years. At a plan. preparedness officials’ efforts to minimum, the policies and procedures (iii) Analyze the ICF/IID’s response to maintain an integrated response during must address the following: and maintain documentation of all a disaster or emergency situation. * * * * * drills, tabletop exercises, and emergency (b) Policies and procedures. The HHA (c) Communication plan. The ICF/IID events, and revise the ICF/IID’s must develop and implement must develop and maintain an emergency plan, as needed. emergency preparedness policies and emergency preparedness * * * * * procedures, based on the emergency communication plan that complies with plan set forth in paragraph (a) of this Federal, State, and local laws and must PART 484—HOME HEALTH SERVICES section, risk assessment at paragraph be reviewed and updated at least every (a)(1) of this section, and the ■ 2 years. The communication plan must 37. The authority citation for part 484 communication plan at paragraph (c) of include the following: continues to read as follows: this section. The policies and * * * * * Authority: Secs. 1102 and 1871 of the procedures must be reviewed and (d) Training and testing. The ICF/IID Social Security Act (42 U.S.C. 1302 and updated at least every 2 years. At a must develop and maintain an 1395(hh)) unless otherwise indicated. minimum, the policies and procedures emergency preparedness training and ■ 38. Section 484.50 is amended by must address the following: testing program that is based on the removing and reserving paragraph (a)(3) * * * * * emergency plan set forth in paragraph and revising paragraph (c)(7) (c) Communication plan. The HHA (a) of this section, risk assessment at introductory text to read as follows: must develop and maintain an

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emergency preparedness events, and revise the HHA’s emergency plan set forth in paragraph (a) of this communication plan that complies with plan, as needed. section, risk assessment at paragraph Federal, State, and local laws and must * * * * * (a)(1) of this section, and the be reviewed and updated at least every ■ 41. Section 484.110 is amended by communication plan at paragraph (c) of 2 years. The communication plan must revising paragraph (e) to read as follows: this section. The policies and include all of the following: procedures must be reviewed and § 484.110 Condition of participation: updated at least every 2 years. At a * * * * * Clinical records. (d) Training and testing. The HHA minimum, the policies and procedures must develop and maintain an * * * * * must address the following: (e) Standard: Retrieval of clinical emergency preparedness training and * * * * * records. A patient’s clinical record testing program that is based on the (c) Communication plan. The CORF (whether hardcopy or electronic form) emergency plan set forth in paragraph must develop and maintain an must be made available to a patient, free (a) of this section, risk assessment at emergency preparedness of charge, upon request within 4 paragraph (a)(1) of this section, policies communication plan that complies with business days. and procedures at paragraph (b) of this Federal, State, and local laws and must section, and the communication plan at PART 485—CONDITIONS OF be reviewed and updated at least every paragraph (c) of this section. The PARTICIPATION: SPECIALIZED 2 years. The communication plan must training and testing program must be PROVIDERS include all of the following: reviewed and updated at least every 2 * * * * * years. ■ 42. The authority citation for part 485 (d) Training and testing. The CORF (1) * * * continues to read as follows: must develop and maintain an (ii) Provide emergency preparedness Authority: Secs. 1102 and 1871 of the emergency preparedness training and training at least every 2 years. Social Security Act (42 U.S.C. 1302 and testing program that is based on the * * * * * 1395(hh)). emergency plan set forth in paragraph (v) If the emergency preparedness ■ 43. Section 485.66 is amended by (a) of this section, risk assessment at policies and procedures are significantly revising the introductory text to read as paragraph (a)(1) of this section, policies updated, the HHA must conduct follows: and procedures at paragraph (b) of this training on the updated policies and section, and the communication plan at § 485.66 Condition of participation: procedures. paragraph (c) of this section. The Utilization review plan. training and testing program must be (2) Testing. The HHA must conduct The facility must have in effect a reviewed and updated at least every 2 exercises to test the emergency plan at written utilization review plan that is years. least annually. The HHA must do the implemented annually, to assess the (1) * * * following: necessity of services and promotes the (ii) Provide emergency preparedness (i) Participate in a full-scale exercise most efficient use of services provided training at least every 2 years. that is community-based or when a by the facility. community-based exercise is not * * * * * (v) If the emergency preparedness accessible, an individual, facility-based * * * * * ■ policies and procedures are significantly functional exercise every 2 years. If the 44. Section 485.68 is amended by— ■ a. Revising paragraphs (a) updated, the CORF must conduct HHA experiences an actual natural or introductory text, (a)(4), (b) introductory training on the updated policies and man-made emergency that requires text, (c) introductory text, (d) procedures. activation of the emergency plan, the introductory text, and (d)(1)(ii); (2) Testing. The CORF must conduct HHA is exempt from engaging in its ■ b. Adding paragraph (d)(1)(v); and exercises to test the emergency plan at next required full-scale community- ■ c. Revising paragraph (d)(2). least annually. The CORF must do the based or individual, facility-based The revisions and addition read as following: functional exercise following the onset follows: (i) Participate in a full-scale exercise of the actual event. that is community-based or when a (ii) Conduct an additional exercise at § 485.68 Condition of participation: Emergency preparedness. community-based exercise is not least every 2 years, opposite the year the accessible, an individual, facility-based full-scale or functional exercise under * * * * * functional exercise every 2 years. If the paragraph (d)(2)(i) of this section is (a) Emergency plan. The CORF must CORF experiences an actual natural or conducted, that may include, but is not develop and maintain an emergency man-made emergency that requires limited to the following: preparedness plan that must be activation of the emergency plan, the (A) A second full-scale exercise that is reviewed and updated at least every 2 CORF is exempt from engaging in its community-based or an individual, years. The plan must do all of the next required community-based or facility-based functional exercise; or following: individual, facility-based functional (B) A mock disaster drill; or * * * * * exercise following the onset of the (C) A tabletop exercise or workshop (4) Include a process for cooperation actual event. that includes a group discussion led by and collaboration with local, tribal, (ii) Conduct an additional exercise at a facilitator, using a narrated, clinically- regional, State, and Federal emergency least every 2 years, opposite the year the relevant emergency scenario, and a set preparedness officials’ efforts to full-scale or functional exercise under of problem statements, directed maintain an integrated response during paragraph (d)(2)(i) of this section is messages, or prepared questions a disaster or emergency situation. conducted, that may include, but is not designed to challenge an emergency * * * * * limited to the following: plan. (b) Policies and procedures. The (A) A second full-scale exercise that is (iii) Analyze the HHA’s response to CORF must develop and implement community-based or an individual, and maintain documentation of all emergency preparedness policies and facility-based functional exercise; or drills, tabletop exercises, and emergency procedures, based on the emergency (B) A mock disaster drill; or

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(C) A tabletop exercise or workshop (a) of this section, risk assessment at professional personnel required under that includes a group discussion led by paragraph (a)(1) of this section, policies paragraph (a)(2) of this section and a facilitator, using a narrated, clinically- and procedures at paragraph (b) of this updated as necessary by the CAH. relevant emergency scenario, and a set section, and the communication plan at * * * * * of problem statements, directed paragraph (c) of this section. The ■ 48. Section 485.645 is amended by— messages, or prepared questions training and testing program must be ■ a. Revising paragraph (d)(1); designed to challenge an emergency reviewed and updated at least every 2 ■ b. Removing paragraph (d)(4); plan. years. ■ c. Redesignating paragraphs (d)(5) (iii) Analyze the CORF’s response to (1) * * * through (9) as paragraphs (d)(4) through and maintain documentation of all (ii) Provide emergency preparedness (8), respectively; and drills, tabletop exercises, and emergency training at least every 2 years. ■ d. Revising newly redesignated events, and revise the CORF’s * * * * * paragraphs (d)(4) and (7). emergency plan, as needed. (v) If the emergency preparedness The revisions read as follows: * * * * * policies and procedures are significantly ■ updated, the CAH must conduct § 485.645 Special requirements for CAH 45. Section 485.625 is amended by— providers of long-term care services ■ a. Revising paragraphs (a) training on the updated policies and (‘‘swing-beds’’). introductory text, (a)(4), (b) introductory procedures. text, (c) introductory text, (d) (2) Testing. The CAH must conduct * * * * * introductory text, and (d)(1)(ii); exercises to test the emergency plan at (d) * * * ■ b. Adding paragraph (d)(1)(v); and least twice per year. The CAH must do (1) Resident rights (§ 483.10(b)(7), ■ c. Revising paragraph (d)(2). the following: (c)(1), (c)(2)(iii), (c)(6), (d), (e)(2) and (4), The revisions and addition read as (i) Participate in a full-scale exercise (f)(4)(ii) and (iii), (g)(8) and (17), (g)(18) follows: that is community-based or when a introductory text, and (h) of this community-based exercise is not chapter). § 485.625 Condition of participation: accessible, an individual, facility-based * * * * * Emergency preparedness. functional exercise once per year. If the (4) Social services (§ 483.40(d) of this * * * * * CAH experiences an actual natural or chapter). (a) Emergency plan. The CAH must man-made emergency that requires * * * * * develop and maintain an emergency activation of the emergency plan, the (7) Dental services (§ 483.55(a)(2), (3), preparedness plan that must be CAH is exempt from engaging in its next (4), and (5) and (b) of this chapter). reviewed and updated at least every 2 required full-scale community-based or * * * * * years. The plan must do all of the individual, facility-based functional ■ 49. Section 485.727 is amended by— following: exercise following the onset of the ■ a. Revising paragraphs (a) * * * * * actual event. introductory text, (a)(5), (b) introductory (4) Include a process for cooperation (ii) Conduct an additional exercise at text, (c) introductory text, (d) and collaboration with local, tribal, least annually, that may include, but is introductory text, and (d)(1)(ii); regional, State, and Federal emergency not limited to the following: ■ b. Adding paragraph (d)(1)(v); and preparedness officials’ efforts to (A) A second full-scale exercise that is ■ c. Revising paragraph (d)(2). maintain an integrated response during community-based or an individual, The revisions and addition read as a disaster or emergency situation. facility-based functional exercise; or follows: (b) Policies and procedures. The CAH (B) A mock disaster drill; or must develop and implement (C) A tabletop exercise or workshop § 485.727 Condition of participation: emergency preparedness policies and that includes a group discussion led by Emergency preparedness. procedures, based on the emergency a facilitator, using a narrated, clinically- * * * * * plan set forth in paragraph (a) of this relevant emergency scenario, and a set (a) Emergency plan. The section, risk assessment at paragraph of problem statements, directed Organizations must develop and (a)(1) of this section, and the messages, or prepared questions maintain an emergency preparedness communication plan at paragraph (c) of designed to challenge an emergency plan that must be reviewed and updated this section. The policies and plan. at least every 2 years. The plan must do procedures must be reviewed and (iii) Analyze the CAH’s response to all of the following: updated at least every 2 years. At a and maintain documentation of all * * * * * minimum, the policies and procedures drills, tabletop exercises, and emergency (5) Include a process for cooperation must address the following: events, and revise the CAH’s emergency and collaboration with local, tribal, * * * * * plan, as needed. regional, State, and Federal emergency (c) Communication plan. The CAH * * * * * preparedness officials’ efforts to must develop and maintain an maintain an integrated response during § 485.627 [Amended] emergency preparedness a disaster or emergency situation. ■ communication plan that complies with 46. Section 485.627 is amended by removing and reserving paragraph * * * * * Federal, State, and local laws and must (b) Policies and procedures. The be reviewed and updated at least every (b)(1). ■ 47. Section 485.635 is amended by Organizations must develop and 2 years. The communication plan must implement emergency preparedness include all of the following: revising paragraph (a)(4) to read as follows: policies and procedures, based on the * * * * * emergency plan set forth in paragraph (d) Training and testing. The CAH § 485.635 Condition of participation: (a) of this section, risk assessment at must develop and maintain an Provision of services. paragraph (a)(1) of this section, and the emergency preparedness training and (a) * * * communication plan at paragraph (c) of testing program that is based on the (4) These policies are reviewed at this section. The policies and emergency plan set forth in paragraph least biennially by the group of procedures must be reviewed and

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updated at least every 2 years. At a designed to challenge an emergency minimum, the policies and procedures minimum, the policies and procedures plan. must address the following: must address the following: (iii) Analyze the Organization’s * * * * * * * * * * response to and maintain (c) Communication plan. The CMHC (c) Communication plan. The documentation of all drills, tabletop must develop and maintain an Organizations must develop and exercises, and emergency events, and emergency preparedness maintain an emergency preparedness revise their emergency plan, as needed. communication plan that complies with communication plan that complies with * * * * * Federal, State, and local laws and must Federal, State, and local laws and must ■ 50. Section 485.914 is amended by be reviewed and updated at least every be reviewed and updated at least every revising paragraphs (d)(1) and (3) to 2 years. The communication plan must 2 years. The communication plan must read as follows: include all of the following: include all of the following: * * * * * * * * * * § 485.914 Condition of participation: (d) Training and testing. The CMHC (d) Training and testing. The Admission, initial evaluation, must develop and maintain an comprehensive assessment, and discharge Organizations must develop and or transfer of the client. emergency preparedness training and maintain an emergency preparedness testing program that is based on the training and testing program that is * * * * * emergency plan set forth in paragraph based on the emergency plan set forth (d) * * * (a) of this section, risk assessment at in paragraph (a) of this section, risk (1) The CMHC must update each paragraph (a)(1) of this section, policies assessment at paragraph (a)(1) of this client’s comprehensive assessment via and procedures at paragraph (b) of this section, policies and procedures at the CMHC interdisciplinary treatment section, and the communication plan at paragraph (b) of this section, and the team, in consultation with the client’s paragraph (c) of this section. The communication plan at paragraph (c) of primary health care provider (if any), training and testing program must be this section. The training and testing when changes in the client’s status, reviewed and updated at least every 2 program must be reviewed and updated responses to treatment, or goal years. If the emergency preparedness at least every 2 years. achievement have occurred and in policies and procedures are significantly (1) * * * accordance with current standards of updated, the CMHC must conduct (ii) Provide emergency preparedness practice. training on the updated policies and training at least every 2 years. * * * * * procedures. * * * * * (3) For clients that receive PHP (1) Training. The CMHC must provide (v) If the emergency preparedness services, the assessment must be initial training in emergency policies and procedures are significantly updated no less frequently than every preparedness policies and procedures to updated, the Organizations must 30 days. all new and existing staff, individuals providing services under arrangement, conduct training on the updated * * * * * and volunteers, consistent with their policies and procedures. ■ (2) Testing. The Organizations must 51. Section 485.920 is amended by expected roles, and maintain conduct exercises to test the emergency revising paragraphs (a) introductory documentation of the training. The plan at least annually. The text, (a)(4), (b) introductory text, (c) CMHC must demonstrate staff Organizations must do the following: introductory text, and (d) to read as knowledge of emergency procedures. (i) Participate in a full-scale exercise follows: Thereafter, the CMHC must provide that is community-based or when a § 485.920 Condition of participation: emergency preparedness training at community-based exercise is not Emergency preparedness. least every 2 years. accessible, an individual, facility-based * * * * * (2) Testing. The CMHC must conduct exercises to test the emergency plan at functional exercise every 2 years. If the (a) Emergency plan. The CMHC must least annually. The CMHC must: Organizations experience an actual develop and maintain an emergency (i) Participate in a full-scale exercise natural or man-made emergency that preparedness plan that must be that is community-based or when a requires activation of the emergency reviewed, and updated at least every 2 community-based exercise is not plan, the organization is exempt from years. The plan must do all of the accessible, an individual, facility-based engaging in its next required full-scale following: community-based or individual, facility- every 2 years. If the CMHC experiences based functional exercise following the * * * * * an actual natural or man-made onset of the actual event. (4) Include a process for cooperation emergency that requires activation of (ii) Conduct an additional exercise at and collaboration with local, tribal, the emergency plan, the CMHC is least every 2 years, opposite the year the regional, State, and Federal emergency exempt from engaging in its next full-scale or functional exercise under preparedness officials’ efforts to required community-based or paragraph (d)(2)(i) of this section is maintain an integrated response during individual, facility-based functional conducted, that may include, but is not a disaster or emergency situation. exercise following the onset of the limited to the following: (b) Policies and procedures. The actual event. (A) A second full-scale exercise that is CMHC must develop and implement (ii) Conduct an additional exercise at community-based or an individual, emergency preparedness policies and least every 2 years, opposite the year the facility-based functional exercise; or procedures, based on the emergency full-scale or functional exercise under (B) A mock disaster drill; or plan set forth in paragraph (a) of this paragraph (d)(2)(i) of this section is (C) A tabletop exercise or workshop section, risk assessment at paragraph conducted, that may include, but is not that includes a group discussion led by (a)(1) of this section, and the limited to following: a facilitator, using a narrated, clinically- communication plan at paragraph (c) of (A) A second full-scale exercise that is relevant emergency scenario, and a set this section. The policies and community-based or an individual, of problem statements, directed procedures must be reviewed and facility-based functional exercise; or messages, or prepared questions updated at least every 2 years. At a (B) A mock disaster drill; or

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(C) A tabletop exercise or workshop ■ 55. Section 486.360 is amended by— updated, the OPO must conduct training that includes a group discussion led by ■ a. Revising paragraphs (a) on the updated policies and procedures. a facilitator, using a narrated, clinically- introductory text, (a)(4), (b) introductory (2) * * * relevant emergency scenario, and a set text, (c) introductory text, (d) (i) Conduct a paper-based, tabletop of problem statements, directed introductory text, and (d)(1)(ii); exercise or workshop at least annually. messages, or prepared questions ■ b. Adding paragraph (d)(1)(v); and A tabletop exercise is a group designed to challenge an emergency ■ c. Revising paragraph (d)(2)(i). discussion led by a facilitator, using a plan. The revisions and addition read as narrated, clinically-relevant emergency (iii) Analyze the CMHC’s response to follows: scenario, and a set of problem and maintain documentation of all statements, directed messages, or drills, tabletop exercises, and emergency § 486.360 Condition for coverage: Emergency preparedness. prepared questions designed to events, and revise the CMHC’s * * * * * challenge an emergency plan. If the emergency plan, as needed. OPO experiences an actual natural or * * * * * (a) Emergency plan. The OPO must develop and maintain an emergency man-made emergency that requires preparedness plan that must be activation of the emergency plan, the PART 486—CONDITIONS FOR OPO is exempt from engaging in its next COVERAGE OF SPECIALIZED reviewed and updated at least every 2 years. The plan must do all of the required testing exercise following the SERVICES FURNISHED BY onset of the actual event. SUPPLIERS following: * * * * * * * * * * ■ 52. The authority citation for part 486 (4) Include a process for cooperation continues to read as follows: PART 488—SURVEY, CERTIFICATION, and collaboration with local, tribal, AND ENFORCEMENT PROCEDURES Authority: Secs. 1102, 1138, and 1871 of regional, State, and Federal emergency the Social Security Act (42 U.S.C. 1302, preparedness officials’ efforts to ■ 56. The authority citation for part 488 1320b–8, and 1395hh) and section 371 of the maintain an integrated response during Public Health Service Act (42 U.S.C 273). continues to read as follows: a disaster or emergency situation. Authority: Secs. 1102, 1128l, 1864, 1865, ■ 53. Section 486.104 is amended by (b) Policies and procedures. The OPO revising paragraph (a) to read as follows: 1871 and 1875 of the Social Security Act, must develop and implement unless otherwise noted (42 U.S.C 1302, § 486.104 Condition for coverage: emergency preparedness policies and 1320a–7j, 1395aa, 1395bb, 1395hh and Qualifications, orientation and health of procedures, based on the emergency 1395ll). technical personnel. plan set forth in paragraph (a) of this section, risk assessment at paragraph § 488.30 [Amended] * * * * * ■ (a) Standard: qualifications of (a)(1) of this section, and, the 57. Section 488.30(a) is amended in technologists. All operators of the communication plan at paragraph (c) of the definition for ‘‘Provider of services, portable X-ray equipment meet the this section. The policies and provider, or supplier’’ by removing the requirements of paragraph (a)(1) or (2) of procedures must be reviewed and phrase ‘‘transplant centers’’ and adding this section. updated at least every 2 years. At a in its place the phrase ‘‘transplant (1) Successful completion of a minimum, the policies and procedures programs’’. program of formal training in X-ray must address the following: ■ 58. Section 488.61 is amended— technology at which the operator * * * * * ■ a. By revising the section heading; received appropriate training and (c) Communication plan. The OPO ■ b. In the introductory text by demonstrated competence in the use of must develop and maintain an removing the phrase ‘‘transplant equipment and administration of emergency preparedness centers’’ and adding in its place the portable x-ray procedures; or communication plan that complies with phrase ‘‘transplant programs’’; (2) Successful completion of 24 full Federal, State, and local laws and must ■ c. In paragraph (a) by removing the months of training and experience be reviewed and updated at least every phrases ‘‘centers’’ and ‘‘center’’ each under the direct supervision of a 2 years. The communication plan must time they appear and adding in their physician who is certified in radiology include all of the following: place the phrases ‘‘programs’’ and or who possesses qualifications which * * * * * ‘‘program,’’ respectively; are equivalent to those required for such (d) Training and testing. The OPO ■ d. In paragraph (a)(2) by removing the certification. must develop and maintain an phrases ‘‘Scientific Registry of * * * * * emergency preparedness training and Transplant Beneficiary (SRTR) center- ■ 54. Section 486.106 is amended by testing program that is based on the specific’’ and ‘‘Scientific Registry of revising paragraph (a)(2) to read as emergency plan set forth in paragraph Transplant Recipient (SRTR) program- follows: (a) of this section, risk assessment at specific’’ and adding in its place the § 486.106 Conditions for coverage: paragraph (a)(1) of this section, policies phrase ‘‘Scientific Registry of Referral for service and preservation of and procedures at paragraph (b) of this Transplant Recipient (SRTR) program- records. section, and the communication plan at specific’’; * * * * * paragraph (c) of this section. The ■ e. By revising paragraph (a)(5); (a) * * * training and testing program must be ■ f. By removing paragraph (c); (2) Such physician or nonphysician reviewed and updated at least every 2 ■ g. By redesignating paragraphs (d) practitioner’s order meets the years. through (h) as paragraphs (c) through requirements at § 410.32 of this chapter, (1) * * * (g), respectively; and includes a statement concerning the (ii) Provide emergency preparedness ■ h. By revising newly redesignated condition of the patient which indicates training at every 2 years. paragraphs (c), (d), (e) introductory text, why portable X-ray services are * * * * * (e)(1) introductory text, (e)(1)(iv), (e)(3), necessary. (v) If the emergency preparedness and (f)(1)(i), (ii), and (iii). * * * * * policies and procedures are significantly The revisions read as follows:

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§ 488.61 Special procedures for approval failures or patient deaths, that have been Authority: Sec. 1102 of the Social Security and re-approval of organ transplant implemented and institutionalized on a Act (42 U.S.C. 1302); and sec. 353 of the programs. sustainable basis, and that are supported Public Health Service Act (42 U.S.C. 263a). * * * * * by outcomes more recent than the latest ■ 60. Section 491.9 is amended by (a) * * * available SRTR report, for which there revising paragraph (b)(4) to read as (5) If CMS determines that a is a sufficient post-transplant patient follows: transplant program has met the data and graft survival period and a submission, clinical experience, and sufficient number of transplants such § 491.9 Provision of services. outcome requirements, CMS will review that CMS finds that the program * * * * * the program’s compliance with the demonstrates present-day compliance (b) * * * conditions of participation contained at with the requirements at (4) These policies are reviewed at §§ 482.72 through 482.76 and §§ 482.90 § 482.80(c)(2)(ii)(C) of this chapter; least biennially by the group of through 482.104 of this chapter using professional personnel required under the procedures described in subpart A * * * * * (3) Timing. Within 14 calendar days paragraph (b)(2) of this section and of this part. If the transplant program is after CMS has issued formal written reviewed as necessary by the RHC or found to be in compliance with all the notice of a condition-level deficiency to FQHC. conditions of participation at §§ 482.72 the program, CMS must receive * * * * * through 482.104 of this chapter, CMS notification of the program’s intent to ■ 61. Section 491.11 is amended by will notify the transplant program in seek mitigating factors approval, and revising paragraph (a) to read as follows: writing of the effective date of its receive all information for consideration Medicare-approval. CMS will notify the of mitigating factors within 120 calendar § 491.11 Program evaluation. transplant program in writing if it is not (a) The clinic or center carries out, or Medicare-approved. days of the CMS written notification for a deficiency due to data submission, arranges for, a biennial evaluation of its * * * * * clinical experience or outcomes at total program. (c) Loss of Medicare approval. § 482.80 of this chapter. Failure to meet * * * * * Programs that have lost their Medicare these timeframes may be the basis for ■ 62. Section 491.12 is amended by— approval may seek re-entry into the denial of mitigating factors. CMS may ■ a. Revising paragraphs (a) Medicare program at any time. A permit an extension of the timeline for introductory text, (a)(4), (b) introductory program that has lost its Medicare good cause, such as a declared public text, (c) introductory text, (d) approval must: introductory text, and (d)(1)(ii); (1) Request initial approval using the health emergency. (f) * * * ■ b. Adding paragraph (d)(1)(v); and procedures described in paragraph (a) of (1) * * * ■ c. Revising paragraph (d)(2). this section; (i) Approve initial approval of a (2) Be in compliance with §§ 482.72 The revisions and addition read as program’s Medicare participation based through 482.104 of this chapter at the follows: upon approval of mitigating factors. time of the request for Medicare (ii) Deny the program’s request for § 491.12 Emergency preparedness. approval; and Medicare approval based on mitigating * * * * * (3) Submit a report to CMS factors. (a) Emergency plan. The RHC or documenting any changes or corrective (iii) Offer a time-limited Systems FQHC must develop and maintain an actions taken by the program as a result Improvement Agreement, in accordance emergency preparedness plan that must of the loss of its Medicare approval with paragraph (g) of this section, when be reviewed and updated at least every status. a transplant program has waived its (d) Transplant program inactivity. A 2 years. The plan must do all of the appeal rights, has implemented transplant program may remain inactive following: substantial program improvements that and retain its Medicare approval for a * * * * * address root causes and are period not to exceed 12 months. A (4) Include a process for cooperation institutionally supported by the transplant program must notify CMS and collaboration with local, tribal, hospital’s governing body on a upon its voluntary inactivation as regional, State, and Federal emergency sustainable basis, and has requested required by § 482.74(a)(3) of this preparedness officials’ efforts to more time to design or implement chapter. maintain an integrated response during (e) Consideration of mitigating factors additional improvements or a disaster or emergency situation. in initial approval survey, certification, demonstrate compliance with CMS (b) Policies and procedures. The RHC and enforcement actions for transplant outcome requirements. Upon or FQHC must develop and implement programs—(1) Factors. Except for completion of the Systems Improvement emergency preparedness policies and situations of immediate jeopardy or Agreement or a CMS finding that the procedures, based on the emergency deficiencies other than failure to meet hospital has failed to meet the terms of plan set forth in paragraph (a) of this requirements at § 482.80 of this chapter, the Agreement, CMS makes a final section, risk assessment at paragraph CMS will consider such mitigating determination of whether to approve or (a)(1) of this section, and the factors as may be appropriate in light of deny a program’s request for Medicare communication plan at paragraph (c) of the nature of the deficiency and approval based on mitigating factors. A this section. The policies and circumstances, including (but not Systems Improvement Agreement procedures must be reviewed and limited to) the following, in making a follows the process specified in updated at least every 2 years. At a decision of initial approval of a paragraph (g) of this section. minimum, the policies and procedures transplant program that does not meet * * * * * must address the following: the data submission, clinical PART 491—CERTIFICATION OF * * * * * experience, or outcome requirements: CERTAIN HEALTH FACILITIES (c) Communication plan. The RHC or * * * * * FQHC must develop and maintain an (iv) Program improvements that ■ 59. The authority citation for part 491 emergency preparedness substantially address root causes of graft continues to read as follows: communication plan that complies with

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Federal, State, and local laws and must PART 494—CONDITIONS FOR (d) Training, testing, and orientation. be reviewed and updated at least every COVERAGE FOR END-STAGE RENAL The dialysis facility must develop and 2 years. The communication plan must DISEASE FACILITIES maintain an emergency preparedness include all of the following: training, testing and patient orientation ■ 63. The authority citation for part 494 * * * * * program that is based on the emergency (d) Training and testing. The RHC or continues to read as follows: plan set forth in paragraph (a) of this FQHC must develop and maintain an Authority: Secs. 1102 and 1871 of the section, risk assessment at paragraph emergency preparedness training and Social Security Act (42 U.S.C. l302 and (a)(1) of this section, policies and testing program that is based on the l395hh). procedures at paragraph (b) of this emergency plan set forth in paragraph ■ 64. Section 494.62 is amended by— section, and the communication plan at (a) of this section, risk assessment at ■ a. Revising paragraphs (a) paragraph (c) of this section. The paragraph (a)(1) of this section, policies introductory text, (a)(4), (b) introductory training, testing, and patient orientation and procedures at paragraph (b) of this text, (c) introductory text, (d) program must be evaluated and updated section, and the communication plan at introductory text, and (d)(1)(ii); at least every 2 years. paragraph (c) of this section. The ■ b. Adding paragraph (d)(1)(vii); and (1) * * * training and testing program must be ■ c. Revising paragraph (d)(2). (ii) Provide emergency preparedness reviewed and updated at least every 2 The revisions and addition read as training at least every 2 years. years. follows: (1) * * * * * * * * (ii) Provide emergency preparedness § 494.62 Condition of participation: (vii) If the emergency preparedness Emergency preparedness. training at least every 2 years. policies and procedures are significantly * * * * * * * * * * updated, the dialysis facility must (v) If the emergency preparedness (a) Emergency plan. The dialysis conduct training on the updated policies and procedures are significantly facility must develop and maintain an policies and procedures. updated, the RHC/FQHC must conduct emergency preparedness plan that must (2) Testing. The dialysis facility must training on the updated policies and be evaluated and updated at least every conduct exercises to test the emergency procedures. 2 years. The plan must do all of the (2) Testing. The RHC or FQHC must following: plan at least annually. The dialysis facility must do all of the following: conduct exercises to test the emergency * * * * * plan at least annually. The RHC or (4) Include a process for cooperation (i) Participate in a full-scale exercise FQHC must do the following: and collaboration with local, tribal, that is community-based or when a (i) Participate in a full-scale exercise regional, State, and Federal emergency community-based exercise is not that is community-based or when a preparedness officials’ efforts to accessible, an individual, a facility- community-based exercise is not maintain an integrated response during based functional exercise every 2 years. accessible, an individual, facility-based a disaster or emergency situation. The If the dialysis facility experiences an functional exercise every 2 years. If the dialysis facility must contact the local actual natural or man-made emergency RHC or FQHC experiences an actual emergency preparedness agency at least that requires activation of the natural or man-made emergency that annually to confirm that the agency is emergency plan, the ESRD is exempt requires activation of the emergency aware of the dialysis facility’s needs in from engaging in its next required full- plan, the RHC or FQHC is exempt from the event of an emergency. scale community-based or individual, engaging in its next required full-scale (b) Policies and procedures. The facility-based functional exercise community-based or individual, facility- dialysis facility must develop and following the onset of the actual event. based functional exercise following the implement emergency preparedness (ii) Conduct an additional exercise at onset of the actual event. policies and procedures, based on the least every 2 years, opposite the year the (ii) Conduct an additional exercise at emergency plan set forth in paragraph full-scale or functional exercise under least every 2 years, opposite the year the (a) of this section, risk assessment at paragraph (d)(2)(i) of this section is full-scale or functional exercise under paragraph (a)(1) of this section, and the conducted, that may include, but is not paragraph (d)(2)(i) of this section is communication plan at paragraph (c) of limited to the following: conducted, that may include, but is not this section. The policies and (A) A second full-scale exercise that is limited to following: procedures must be reviewed and (A) A second full-scale exercise that is community-based or an individual, updated at least every 2 years. These community-based or an individual, facility-based functional exercise; or emergencies include, but are not limited facility-based functional exercise; or (B) A mock disaster drill; or (B) A mock disaster drill; or to, fire, equipment or power failures, (C) A tabletop exercise or workshop care-related emergencies, water supply (C) A tabletop exercise or workshop that includes a group discussion led by interruption, and natural disasters likely that includes a group discussion led by a facilitator, using a narrated, clinically- to occur in the facility’s geographic area. a facilitator, using a narrated, clinically- relevant emergency scenario, and a set At a minimum, the policies and relevant emergency scenario, and a set of problem statements, directed procedures must address the following: of problem statements, directed messages, or prepared questions * * * * * messages, or prepared questions designed to challenge an emergency (c) Communication plan. The dialysis designed to challenge an emergency plan. facility must develop and maintain an plan. (iii) Analyze the RHC or FQHC’s emergency preparedness (iii) Analyze the dialysis facility’s response to and maintain communication plan that complies with response to and maintain documentation of all drills, tabletop Federal, State, and local laws and must documentation of all drills, tabletop exercises, and emergency events, and be reviewed and updated at least every exercises, and emergency events, and revise the RHC or FQHC’s emergency 2 years. The communication plan must revise the dialysis facility’s emergency plan, as needed. include all of the following: plan, as needed. * * * * * * * * * * * * * * *

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Dated: August 6, 2018. Seema Verma, Administrator, Centers for Medicare & Medicaid Services. Dated: August 9, 2018. Alex M. Azar II, Secretary, Department of Health and Human Services. [FR Doc. 2018–19599 Filed 9–17–18; 11:15 am] BILLING CODE 4120–01–P

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Part III

Department of Transportation

Federal Motor Carrier Safety Administration 49 CFR Part 390 Lease and Interchange of Vehicles; Motor Carriers of Passengers; Proposed Rule

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DEPARTMENT OF TRANSPORTATION Comments’’ portion of the K. Privacy SUPPLEMENTARY INFORMATION section L. E.O. 12372 (Intergovernmental Review) Federal Motor Carrier Safety below for instructions on submitting M. E.O. 13211 (Energy Supply, Administration Distribution, or Use) comments. N. E.O. 13783 (Promoting Energy FOR FURTHER INFORMATION CONTACT: Ms. Independence and Economic Growth) 49 CFR Part 390 Loretta Bitner, (202) 366–2400, O. E.O. 13175 (Indian Tribal Governments) [Docket No. FMCSA–2012–0103] [email protected], Office of P. National Technology Transfer and Enforcement and Compliance. FMCSA Advancement Act (Technical Standards) RIN 2126–AC07 Q. Environment (NEPA, CAA, E.O. 12898 office hours are from 9 a.m. to 5 p.m., Environmental Justice) Lease and Interchange of Vehicles; Monday through Friday, except Federal Motor Carriers of Passengers holidays. I. Public Participation and Request for SUPPLEMENTARY INFORMATION: This Comments AGENCY: Federal Motor Carrier Safety notice of proposed rulemaking (NPRM) Administration (FMCSA), DOT. FMCSA encourages you to participate is organized as follows: in this rulemaking by submitting ACTION: Notice of proposed rulemaking I. Public Participation and Request for (NPRM); request for comments. comments, reply comments, and related Comments materials. All comments received will A. Submitting Comments be posted without change to http:// SUMMARY: FMCSA proposes to amend its B. Viewing Comments and Documents May 27, 2015, Lease and Interchange of C. Privacy Act www.regulations.gov and will include Vehicles; Motor Carriers of Passengers D. Waiver of Advance Notice of Proposed any personal information you provide. final rule in response to petitions for Rulemaking A. Submitting Comments rulemaking and extend the January 1, E. Comments on the Collection of 2019, compliance date to January 1, Information If you submit a comment, please 2021. Today’s proposal would narrow II. Acronyms and Abbreviations include the docket number for this the applicability of the rule, by III. Executive Summary NPRM (Docket No. FMCSA–2012– A. Purpose of the Proposed Rule 0103), indicate the specific section of excluding from the definition of lease B. Summary of the Major Provisions and the associated regulatory this document to which each comment C. Costs and Benefits applies, and provide a reason for each requirements, certain contracts and IV. Legal Basis for the Rulemaking other agreements between motor carriers V. Rulemaking History and Purpose recommendation. You may submit your of passengers that have active passenger VI. Petitions for Reconsideration and comments and material online or by fax, carrier operating authority registrations Subsequent Events mail, or hand delivery, but please use with FMCSA. For passenger carriers that A. History of Petitions only one of these means. FMCSA would remain subject to the leasing and B. Discussion of Comments and Responses recommends that you include your to the June 16, 2017 Proposal in name and a mailing address, an email interchange requirements, FMCSA Response to Petitions for proposes to return the bus marking address, or a phone number in the body Reconsideration of your document so that the Agency requirement to its July 1, 2015, state VII. General Discussion of the Proposed Rule with slight modifications to add A. Discussion of the Proposed Rule can contact you if there are questions references to leased vehicles; revise the B. Examples of Proposed Rule regarding your submission. delayed writing of a lease during certain Implementation To submit your comment online, go to emergencies; and remove the 24-hour C. Alternatives http://www.regulations.gov, put the lease notification requirement. This VIII. International Impacts docket number, FMCSA–2012–0103, in IX. Section-by-Section Description of the proposal would be a deregulatory action the keyword box, and click ‘‘Search.’’ Proposed Rule When the new screen appears, click on as defined by Executive Order 13771, A. Section 390.5 (Suspended) and 390.5T ‘‘Reducing Regulation and Controlling the ‘‘Comment Now!’’ button and type Definitions your comment into the text box on the Regulatory Costs.’’ B. Section 390.21 (Suspended) and 390.21T Marking of Self-Propelled CMVs following screen. Choose whether you DATES: Comments must be received by are submitting your comment as an November 19, 2018. and Intermodal Equipment C. Part 390, Subpart F Lease and individual or on behalf of a third party ADDRESSES: You may submit comments Interchange of Passenger-Carrying and then submit. identified by Docket Number FMCSA– Commercial Motor Vehicles If you submit your comments by mail 2012–0103 using any of the following D. Part 390, Subpart G Lease and or hand delivery, submit them in an methods: Interchange of Passenger-Carrying unbound format, no larger than 81⁄2 by • Website: http:// Commercial Motor Vehicles 11 inches, suitable for copying and www.regulations.gov. Follow the E. Section 390.401 Applicability electronic filing. If you submit instructions for submitting comments F. Section 390.403 Lease and Interchange Requirements comments by mail and would like to on the Federal electronic docket site. X. Regulatory Analyses know that they reached the facility, • Fax: 1–202–493–2251. please enclose a stamped, self-addressed • A. E.O. 12866 (Regulatory Planning and Mail: Docket Services, U.S. Review), E.O. 13563 (Improving postcard or envelope. Department of Transportation, Room Regulation and Regulatory Review), and FMCSA will consider all comments W12–140, 1200 New Jersey Avenue SE., DOT Regulatory Policies and Procedures and material received during the Washington, DC 20590–0001. B. E.O. 13771 (Reducing Regulation and comment period and may change this • Hand Delivery: Ground Floor, Room Controlling Regulatory Costs) proposed rule based on your comments. W12–140, DOT Building, 1200 New C. Regulatory Flexibility Act FMCSA may issue a final rule at any Jersey Avenue SE, Washington, DC, D. Assistance for Small Entities E. Unfunded Mandates Reform Act of 1995 time after the close of the comment between 9 a.m. and 5 p.m. Monday F. Paperwork Reduction Act period. through Friday, except Federal holidays. G. E.O. 13132 (Federalism) B. Viewing Comments and Documents To avoid duplication, please use only H. E.O. 12988 (Civil Justice Reform) one of these four methods. See the I. E.O. 13045 (Protection of Children) To view comments, as well as any ‘‘Public Participation and Request for J. E.O. 12630 (Taking of Private Property) documents mentioned in this preamble

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as being available in the docket, go to comments were placed in the docket of VIN ...... Vehicle Identification Number. http://www.regulations.gov. Insert the this rulemaking. docket number, FMCSA–2012–0103, in On June 16, 2017, FMCSA published III. Executive Summary the keyword box, and click ‘‘Search.’’ a proposal (2017 proposal) in the A. Purpose of the Proposed Rule Next, click the ‘‘Open Docket Folder’’ Federal Register (82 FR 27768). The button and choose the document to 2017 proposal provided information Based on a review of the petitions for review. If you do not have access to the about FMCSA’s planned revisions to the reconsideration and stakeholder input, internet, you may view the docket 2015 final rule and requested public FMCSA proposes to revise its online by visiting the Docket comment on the proposed revisions. regulations governing the lease and Management Facility in Room W12–140 The 2017 proposal and comments interchange of passenger-carrying on the ground floor of the DOT West received are discussed in more detail commercial motor vehicles (CMVs). Building, 1200 New Jersey Avenue SE, below. This proposed rule would exclude Washington, DC 20590, between 9 a.m. The Agency’s intent to issue this motor carriers that operate CMVs and and 5 p.m., e.t., Monday through Friday, NPRM has been announced repeatedly, have active operating authority except Federal holidays. with opportunities for stakeholder registration with FMCSA to transport comment available at each stage. passengers—hereafter called C. Privacy Act Therefore, FMCSA believes a further ‘‘authorized carriers’’ or ‘‘carriers with In accordance with 5 U.S.C. 553(c), opportunity to provide comments before operating authority’’ for the sake of DOT solicits comments from the public issuance of this NPRM would be simplicity—from the lease and to better inform its rulemaking process. unnecessary. interchange requirements. For leases DOT posts these comments, without between authorized carriers, because E. Comments on the Collection of FMCSA believes their identity can be edit, including any personal information Information the commenter provides, to determined by other means, the www.regulations.gov, as described in If you have comments on the assignment of responsibility for the system of records notice (DOT/ALL– collection of information discussed in regulatory compliance would require no 14 FDMS), which can be reviewed at this NPRM, you must also send those additional regulatory obligations. FMCSA also proposes to extend the www.transportation.gov/privacy. comments to the Office of Information and Regulatory Affairs at Office of compliance date for the 2015 final rule D. Waiver of Advance Notice of Management and Budget (OMB). To to January 1, 2021, to give the Agency Proposed Rulemaking ensure that your comments are received sufficient time to complete this on time, the preferred methods of rulemaking. Under 49 U.S.C. 31136(g)(1), as _ amended by section 5202 of the Fixing submission are by email to oira B. Summary of the Major Provisions [email protected] (include America’s Surface Transportation The proposed rule would (1) revise (FAST) Act, Public Law 114–94, for any docket number ‘‘FMCSA–2012–0103’’ and ‘‘Attention: Desk Officer for the definition of lease to exclude regulatory proposal likely to lead to the authorized carriers that grant the use of publication of a major rule,. FMCSA is FMCSA, DOT’’ in the subject line of the email) or fax at 202 395 6566. An their vehicles to each other; (2) retain required to publish an advance notice of the provisions adopted in 2015 to proposed rulemaking (ANPRM), unless alternative, though slower, method is by U.S. Mail to the Office of Information identify the party responsible for the Agency finds good cause pursuant to compliance with the Federal Motor sec. 31136(g)(3) that an ANPRM is and Regulatory Affairs, Office of Management and Budget, 725 17th Carrier Safety Regulations (FMCSRs) impracticable, unnecessary, or contrary when at least one of the passenger to the public interest. For purposes of Street NW, Washington, DC 20503, ATTN: Desk Officer, FMCSA, DOT. carriers involved in the lease or compliance with the FAST Act, the interchange of CMVs is not an Agency has adopted the Congressional II. Acronyms and Abbreviations authorized carrier; (3) ensure that a Review Act’s definition of ‘‘major rule’’ lessor subject to the proposed rule, i.e., (5 U.S.C. 804(2)), namely a rule that has 1935 Act ... Motor Carrier Act of 1935. the entity providing the vehicle, an annual effect on the economy of $100 1984 Act ... Motor Carrier Safety Act of 1984. ABA ...... American Bus Association. surrenders control of the CMV for the million or more. This final rule is not a BLS ...... Bureau of Labor Statistics. full term of the lease or temporary major rule by that standard and 49 CMV ...... Commercial Motor Vehicle. exchange of CMVs; (4) remove the May U.S.C. 31136(g)(1) therefore does not DOT ...... United States Department of Transpor- tation. 27, 2015 final rule’s marking apply. Even if it were a major rule, E.O ...... Executive Order. requirements and return the marking however, FMCSA would find an FMCSA ..... Federal Motor Carrier Safety Adminis- rule in 49 CFR 390.21(e), with slight ANPRM to be unnecessary. tration. modifications; (5) revise the provision On August 31, 2016, FMCSA FMCSRs ... Federal Motor Carrier Safety Regula- tions, 49 CFR parts 350 through allowing a delay in the completion of a published a notice of intent (2016 NOI) 399. lease during certain emergencies; and announcing that four potential changes FR ...... Federal Register. (6) remove the requirement that motor to the final rule were under L&I ...... Licensing and Insurance. carriers that are hired to provide charter consideration and its plan to issue a MAP–21 ... Moving Ahead for Progress in the 21st Century Act. transportation and lease a CMV from rulemaking notice to reconsider those MCMIS ..... Motor Carrier Management Information another carrier notify the tour operator four areas of concern (81 FR 59951). The System. or group of passengers about the lease four changes are discussed in more NOI ...... Notice of Intent. and the lessor. FMCSA requests detail later in this proposal. NPRM ...... Notice of Proposed Rulemaking. NTSB ...... National Transportation Safety Board. comments to identify other methods to FMCSA held a public roundtable on OMB ...... Office of Management and Budget. achieve the safety objectives of this October 31, 2016 to discuss the four PRA ...... Paperwork Reduction Act of 1995. rulemaking. issues outlined in the 2016 NOI. The RFA ...... Regulatory Flexibility Act. SBA ...... Small Business Administration. C. Costs and Benefits stakeholders represented spoke about SOC ...... Standard Occupational Classification. those issues and provided information STB ...... Surface Transportation Board. The Agency estimates that annually on how to address them. All public UMA ...... United Motorcoach Association. 8,215 motor carriers of passengers and

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537,134 passenger-carrying CMV trips percent of these passenger carriers and on an undiscounted basis, $66.5 million would experience regulatory relief CMV trips would experience partial discounted at 3 percent, and $57.5 under the proposed rule. The Agency regulatory relief and remain subject to million discounted at 7 percent over the estimates that approximately 75 percent reduced lease and interchange 10-year analysis period. Expressed on of these passenger carriers and CMV requirements, compared to those of the an annualized basis, this equates to a trips would experience full regulatory 2015 final rule. 10-year cost savings of $7.8 million at a relief and would no longer be subject to As presented in Table 1, the Agency 3 percent discount rate and $8.2 million the lease and interchange requirements estimates that the proposed rule would at a 7 percent discount rate. of the 2015 final rule. The remaining 25 result in a cost savings of $75.1 million TABLE 1—SUMMARY OF THE TOTAL COST OF THE PROPOSED RULE [In thousands of 2016$]

Passenger-carrying Undiscounted Discounted Passenger carriers CMV trips experiencing experiencing Year regulatory relief regulatory relief Lease and Charter party Total Discounted Discounted under the proposed interchange notification (a) under the proposed (b) costs at 3% at 7% rule rule costs costs

2019 ...... 7,906 516,952 ($25,298) ($1,168) ($26,467) ($25,697) ($24,736) 2020 ...... 7,973 521,337 (4,042) (1,178) (5,221) (4,921) (4,560) 2021 ...... 8,041 525,758 (4,077) (1,188) (5,265) (4,819) (4,298) 2022 ...... 8,109 530,217 (4,111) (1,198) (5,310) (4,718) (4,051) 2023 ...... 8,178 534,714 (4,146) (1,208) (5,355) (4,619) (3,818) 2024 ...... 8,247 539,249 (4,182) (1,219) (5,401) (4,523) (3,599) 2025 ...... 8,317 543,822 (4,217) (1,229) (5,446) (4,428) (3,392) 2026 ...... 8,387 548,434 (4,252) (1,239) (5,493) (4,336) (3,197) 2027 ...... 8,459 553,085 (4,289) (1,250) (5,539) (4,245) (3,013) 2028 ...... 8,530 557,776 (4,326) (1,261) (5,586) (4,157) (2,840)

Total ...... (62,946) (12,139) (75,084) (66,463) (57,504) Annualized ...... (7,508) (7,792) (8,187) Notes: (a) Total cost values may not equal the sum of the components due to rounding. (The totals shown in this column are the rounded sum of unrounded components.) (b) Values shown in parentheses are negative values (i.e., less than zero) and represent a decrease in cost or a cost savings.

The regulatory evaluation for the 2015 between lease and interchange of, and standards of equipment of, a final rule addressed the potential safety requirements for passenger-carrying motor private carrier, when needed to benefits of lease and interchange CMVs and improved safety outcomes. promote safety of operation’’ (49 U.S.C. requirements for motor carriers of Lease and interchange requirements for 31502(b)).2 passengers.1 There were insufficient motor carriers of passengers improve the The 1984 Act confers on DOT data and empirical evidence to ability of the Agency and our State authority to regulate drivers, motor demonstrate a measurable quantitative partners to attribute the inspection, carriers, and vehicle equipment. ‘‘At a relationship between lease and compliance, enforcement, and safety minimum, the regulations shall ensure interchange requirements for passenger- data to the correct motor carrier and that—(1) commercial motor vehicles are carrying CMVs and improved safety driver, allowing FMCSA and our State maintained, equipped, loaded, and outcomes such as reduced frequency partners to more accurately identify operated safely; (2) the responsibilities and/or severity of crashes or reduced unsafe carriers and initiate appropriate imposed on operators of commercial frequency of violations. Therefore, interventions. FMCSA believes that the motor vehicles do not impair their FMCSA performed a threshold analysis, lease and interchange requirements of ability to operate the vehicles safely; (3) also referred to as a break-even analysis, the proposed rule are a less costly and the physical condition of operators of estimating the reduction in crashes that burdensome regulatory approach than commercial motor vehicles is adequate would need to occur as a consequence the requirements of the 2015 final rule, to enable them to operate the vehicles of the 2015 final rule in order for the yet still enable safety officials and the safely . . .; and (4) the operation of benefits of the rule to exactly offset the general public to sufficiently identify commercial motor vehicles does not estimated costs of the rule. the passenger carrier responsible for have a deleterious effect on the physical In considering the potential impact to safety. Therefore, the Agency does not condition of the operators’’ (49 U.S.C. safety benefits from today’s proposed anticipate any change to safety benefits 31136(a)). Section 32911 of the Moving rule, the Agency notes that there as a result of the proposed rule. Ahead for Progress in the 21st Century remains insufficient data and empirical IV. Legal Basis for the Rulemaking Act (MAP–21) [Pub. L. 112–141, 126 evidence to clearly demonstrate a Stat. 405, 818, July 6, 2012] enacted a measurable quantitative relationship This rule is based on the authority of fifth requirement, i.e., to ensure that ‘‘(5) the Motor Carrier Act of 1935 (1935 Act) an operator of a commercial motor 1 U.S. Department of Transportation (DOT), and the Motor Carrier Safety Act of 1984 vehicle is not coerced by a motor Federal Motor Carrier Safety Administration (1984 Act), as amended. (FMCSA). ‘‘Final Rule, Lease and Interchange of carrier, shipper, receiver, or Vehicles; Motor Carriers of Passengers. Regulatory The 1935 Act authorizes DOT to transportation intermediary to operate a Evaluation.’’ (Lease and Interchange of Vehicles, ‘‘prescribe requirements for—(1) commercial motor vehicle in violation Motor Carriers of Passengers, 2015 Final Rule qualifications and maximum hours of of a regulation promulgated under this Regulatory Evaluation). May 2015. Available at: service of employees of, and safety of https://www.regulations.gov/contentStreamer ?documentId=FMCSA-2012-0103-0022&attach operation and equipment of, a motor 2 See https://www.gpo.gov/fdsys/pkg/USCODE- mentNumber=1&contentType=pdf (accessed March carrier; and (2) qualifications and 2015-title49/pdf/USCODE-2015-title49-subtitleVI- 9, 2018). maximum hours of service of employees partB-chap315.pdf.

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section, or chapter 51 or chapter 313 of rented, loaned, leased, interchanged, The Agency ultimately received 37 this title’’ [49 U.S.C. 31136(a)(5)].3 assigned, and reassigned with few petitions for reconsideration which have The 1984 Act also includes more records and little formality, which been filed in the public docket general authority to ‘‘(8) prescribe obscured the operational safety referenced above. In addition, 11 recordkeeping . . . requirements; . . . responsibility of many industry informal comments were received. and (10) perform other acts the participants. Multiple affiliated entities Upon review of these requests, FMCSA Secretary considers appropriate’’ (49 shared drivers and vehicles within their concluded that some have merit. U.S.C. 31133(a)).4 network intentionally to avoid FMCSA, therefore, extended the This rule imposes legal and identification of the motor carrier compliance date of the final rule from recordkeeping requirements consistent responsible for safety management, and January 1, 2017, to January 1, 2018, to with the 1935 and 1984 Acts on certain to conceal excessive and illegal driver allow the Agency time to complete its for-hire and private passenger carriers work hours that resulted in fatigue- analysis and amend the rule where that operate CMVs, to enable safety related crashes in some cases. necessary (82 FR 13998, Mar. 16, 2016). officials and the general public to Investigators were eventually able to The petitioners argued and explained identify the passenger carrier document multiple patterns of serious in more detail that FMCSA had taken a responsible for safety. Currently, safety violations by three networks of regulatory scheme from the trucking passenger-carrying CMVs and drivers businesses that deliberately structured industry and applied it to the bus are frequently rented, loaned, leased, their operations to evade Federal industry, which has a vastly different interchanged, assigned, and reassigned regulatory oversight. Each time FMCSA operating structure and liability regime. with few records and little formality, had shut them down in the past, the Moreover, the application of these truck thus obscuring the operational safety three networks re-created or regulations to the bus industry offered responsibility of many industry reincarnated themselves. These no additional protection to the public participants. Because this rule has only companies, which together transported from illegal or unsafe bus operators. indirect and minimal application to almost 2,000 passengers daily, showed Petitioners further stated that the final drivers of passenger-carrying CMVs—at flagrant disregard for public safety by rule created an economic and regulatory most, their employers might require using drivers without valid commercial burden for passenger carriers that them to pick up a lease document and driver’s licenses or medical already operate safely and have a high place it on the vehicle, though that task qualification certificates, failing to degree of compliance. By imposing lease could also be assigned to other conduct required drug testing of drivers, requirements, some of the petitioners employees—FMCSA believes that allowing or requiring drivers to exceed argued, the rule did not affect carriers coercion of drivers to violate the rule the maximum number of driving hours, that choose to violate the regulations, will not occur. and operating buses that were but instead burdened those who already Before prescribing any regulations, mechanically unsafe and in disrepair. operate safely and are in compliance. FMCSA must also consider their ‘‘costs FMCSA shut down these three networks Another petitioner stated that, while it and benefits’’ (49 U.S.C. 31136(c)(2)(A) of bus operators after a time-consuming, supported efforts to identify and address and 31502(d)). Those factors are also complex and detailed review of their chameleon carriers or carriers that may discussed in this proposed rule. operations. try to operate under the cloak of another V. Rulemaking History and Purpose In response to an NPRM intended to carrier, the final rule did not accomplish this goal and, in fact, provided a On September 20, 2013, FMCSA better ensure the correct identity of the motor carrier responsible for the roadmap for irresponsible carriers to published an NPRM that discussed the operate legally under the authority of National Transportation Safety Board’s operation of a passenger-carrying vehicle, 12 parties submitted comments. another carrier. (NTSB) recommendation that FMCSA One carrier stated that it had On May 27, 2015, FMCSA published a regulate the leasing of passenger carriers identified several instances where the final rule (2015 final rule) concerning in much the same way as it regulates the final rule lacked sufficient clarity to the lease and interchange of passenger- leasing of for-hire property carriers (78 enable it to comply, and that these issue carrying CMVs (80 FR 30164). Although FR 57822). This NTSB recommendation areas affected all of its operations. The several of the proposed regulations were resulted from several investigations of final rule also added administrative revised in response to comments bus crashes that occurred in 2008 (78 FR costs and reduced operational flexibility received in response to the NPRM, the 57822, 57824–57826). Starting in 2011, for charter and tour bus operations, motorcoach industry took exception to FMCSA investigated bus companies which would, in the end, reduce some of the requirements of the final operating unsafely along the I–95 connectivity and transportation options rule. The Agency published several corridor. That investigation uncovered for the traveling public. Another carrier documents to respond to the industry additional problems and serious safety named two insurance companies that objections. These documents are violations with other carriers. As have restrictions in their policies that discussed in detail in the following Agency investigators tried to understand prohibit the use of non-owned section. the relationships and links between bus equipment and non-employed drivers, companies operating in complex VI. Petitions for Reconsideration and which were major concerns of the networks, they encountered significant Subsequent Events NPRM and final rule. difficulties in identifying the motor On August 31, 2016, FMCSA carriers responsible for regulatory A. History of Petitions published the 2016 NOI announcing compliance on numerous trips. Vehicles The American Bus Association (ABA) that the following four potential changes and drivers were found to be frequently and United Motorcoach Association to the final rule were under (UMA) filed a joint request for an consideration: 3 See https://www.gpo.gov/fdsys/pkg/USCODE- extension of the June 26, 2015, deadline (1) Exclusion of ‘‘chartering’’ from the 2015-title49/pdf/USCODE-2015-title49-subtitleVI- for the submission of petitions for definition of lease in 49 CFR 390.5. The partB-chap311-subchapIII-sec31136.pdf. 2015 rule merged the concepts of 4 See https://www.gpo.gov/fdsys/pkg/USCODE- reconsideration of the final rule. On July 2015-title49/pdf/USCODE-2015-title49-subtitleVI- 1, 2015, FMCSA extended the deadline leasing with ‘‘chartering’’ partB-chap311-subchapIII-sec31133.pdf. to August 25, 2015 (80 FR 37553). (subcontracting or reassigning

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contracts). Authorized carriers routinely vehicles from other carriers to meet the Trailways, California Bus Association, subcontract or reassign contracts to demand. There might be a last-minute Capitol Bus Lines Inc., Connecticut Bus other authorized carriers to handle maintenance or mechanical issue, or Association, FTI Coach Lines, Georgia demand surges, emergencies, or events driver illness, that arises late in the Motorcoach Operators Association, that require more than the available evening or during the night (such as on Indian Trails, Inc., Minnesota Charter capacity. Subcontractors or assignees a multi-day charter or tour trip), or just Bus Operator’s Association, Onondaga with their own operating authority have prior to picking up a group for a charter Coach Corp., Pennsylvania Bus traditionally assumed responsibility for or scheduled service run. Association, Shuttle Express, Inc., and their own vehicles and drivers. Under In the 2016 NOI, FMCSA announced Trans-Bridge Lines. the 2015 rule, however, a passenger its plan to issue a rulemaking notice to FMCSA also received unique carrier that subcontracted or reassigned reconsider the four areas of concern comments from Academy Bus LLC and work to another carrier would be listed above. The Agency expressed its Greyhound Lines, Inc.; Delainey Banks, responsible for that second carrier’s belief that it might be possible to adopt an individual; Coach USA, a non-carrier compliance with the regulations. less burdensome regulatory alternatives entity that controls numerous motor Petitioners claimed that making a carrier that would not adversely impact safety. carriers of passengers; Reston responsible for the subcontractor’s or FMCSA also explicitly denied other Limousine; National Interstate assignees’ vehicles, drivers, and liability requested revisions because they would Insurance; and the UMA. would make most short-term either have impaired the purpose of the Request for an NPRM subcontracts impossible. final rule or did not represent practical (2) Amending the CMV requirements alternatives. Neither the 2016 NOI nor the 2017 for the location of temporary markings proposal contained specific regulatory for leased/interchanged vehicles (49 Public Roundtable text. The 2016 NOI announced CFR 390.21(f), 390.303(f)). The FMCSA held a public roundtable on FMCSA’s intent to revise the 2015 final petitioners argued that the frequent October 31, 2016 to discuss the four rule in response to petitions. As marking changes needed during leases issues outlined in the 2016 NOI. The indicated above, the 2016 NOI described or interchanges would be impractical stakeholders represented spoke about four major changes that were under and unnecessary because the those issues and provided the Agency consideration for regulatory changes. information required is recorded on the with information on how to address In the 2017 proposal, the Agency driver’s records of duty status for safety them. All public comments were placed identified its intention to revise the inspectors and safety investigators to in the docket of this rulemaking. regulations to address ‘‘chartering’’ and review; carriers would have to depend the 48 hour delay in preparing a lease. Second Extension of Compliance Date completely on drivers to properly Comments: Industry commenters, and the Proposal in Response to change vehicle markings dozens of including Academy Bus LLC., times per day in remote locations; and Petitions for Reconsideration Greyhound Lines, Inc., UMA, Coach it would be unlikely that a member of On June 16, 2017, FMCSA published USA, and DATTCO, Inc. asked FMCSA the public would understand the a final rule (2017 final rule) and a 2017 to publish a formal NPRM that included significance of the markings in the event proposal in the Federal Register (82 FR proposed regulatory text. Coach USA, that he or she focused on the temporary 27766, and 27768). The 2017 final rule among others, noted that the 2017 ‘‘operated by’’ markings rather than the extended the compliance date of the proposal limited its discussion to only permanent markings on the bus 2015 final rule from January 1, 2018, to two of the four issues addressed in the representing the vehicle owner or long- January 1, 2019. The 2017 proposal 2016 NOI; however, they believed that term lessee. provided information about FMCSA’s all four issues should be addressed in (3) Changing the requirement that planned revisions to the 2015 final rule rulemaking. carriers notify customers within 24 and requested public comment on the FMCSA Response: After publication hours when they subcontract service to proposed revisions. of the 2016 NOI, FMCSA decided to other carriers (49 CFR 390.305). publish an NPRM to continue the Petitioners argued that a 24-hour B. Discussion of Comments and process of revising subpart F of 49 CFR deadline is impractical because if an Responses to the June 16, 2017 Proposal part 390. FMCSA proposes to maintain emergency maintenance issue occurs, it in Response to Petitions for and expand the emergency 48-hour may not be possible to notify the Reconsideration delay in preparing a lease. FMCSA customer in a timely manner, FMCSA received 24 comments in proposes to remove the 2015 final rule’s particularly if the issue occurs on the response to the 2017 proposal regarding CMV marking requirements when a weekend, when the customer’s offices the petitions for reconsideration. Two passenger-carrying CMV is leased or are closed, and the trip is scheduled to submissions requested an extension of interchanged. Furthermore, FMCSA start before the customer’s Monday time to comment, one from Coach USA proposes changes that would reduce the opening time. and another from Adirondack number of required leases because (4) Expanding the 48-hour delay in Trailways, Pine Hill Trailways and New authorized carriers would not be subject preparing a lease to include emergencies York Trailways. to this proposed rule when using when passengers are not actually on The following commenters (hereafter vehicles or acquiring transportation board a bus (49 CFR 390.303(a)(2)). the ‘‘industry commenters’’), submitted services from other authorized carriers. Sometimes events requiring a responses to the June 2017 proposal that replacement vehicle might occur when were largely the same, both in wording Lease and Interchange there are no passengers on a vehicle, and in format. The industry commenters The 2015 final rule merged the such as when Amtrak or airline service include: AC Coach Operations, Inc. dba concepts of leasing and chartering (or is suspended or disrupted and buses are Anderson Coach and Travel, subcontracting). Carriers routinely needed to transport stranded Adirondack Trailways, Pine Hill subcontract work to other registered passengers. A bus operator contracted to Trailways and New York Trailways carriers to handle demand surges, provide the emergency service might (Responding together), ABA, Beeline emergencies, or events that require more need to obtain additional drivers and Charters and Tours, Burlington than their available capacity.

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Subcontractors with their own operating protect the traveling public without the arrangements with secondary carriers authority have traditionally assumed burden of the lease and marking must often be made at the last minute. responsibility for their own vehicles or requirement. Capitol Bus Lines, Inc. Industry commenters added that the drivers. Under the 2015 rule, however, reported that, as a result of its need to Agency should clarify that the current a passenger carrier that subcontracted comply with the 2015 final rule definition of the term ‘‘interchange’’ in work to another carrier would be requirements, it lost the ability to § 390.5, as used in § 390.21(f) and responsible for that second carrier’s provide shuttle service for a large subpart F of part 390, does not include compliance with the regulations. In the fireworks display, which cost the the act of providing a passenger-carrying 2015 final rule, FMCSA used the company business. UMA believed the CMV by one motor carrier of passengers following definition for ‘‘Lease’’ in rule needlessly harms passenger groups to another. The industry commenters § 390.5: ‘‘Lease, as used in § 390.21(f) and carriers in need of immediate suggested edits to the definition of and subpart F of this part, means a assistance. Greyhound wrote the rule ‘‘interchange’’ that they believed would contract or arrangement in which a would severely curtail, if not eliminate, resolve the issue. motor carrier grants the use of a its leasing of buses to meet peak period FMCSA Response: Under this NPRM, passenger-carrying commercial motor demand. authorized carriers would not be subject vehicle to another motor carrier, with or Industry commenters believed that without a driver, for a specified period to leasing requirements when they use the rule may exacerbate the problem of vehicles or acquire transportation for the transportation of passengers, in non-compliant carriers by creating safe exchange for compensation. The term services from other authorized carriers. havens and encouraging a switch from FMCSA believes this proposed lease includes an interchange, as chartering to passenger broker defined in this section, or other regulatory change, as explained operations that the Agency has no elsewhere in this NPRM, would resolve agreement granting the use of a authority to regulate. UMA commented passenger-carrying commercial motor the objections and concerns of most that the rule does not identify commenters, without impacting safety. vehicle for a specified period, with or chameleon carriers, but instead provides without a driver, whether or not a roadmap for carriers that may have Assignment of Responsibility compensation for such use is specified compliance or operating authority or required.’’ The 2016 NOI indicated issues. UMA thought the rule might The 2015 final rule governing the that the Agency would address, through compel special event organizers and lease and interchange of passenger- rulemaking, this concern relating to the community leaders to spend needless carrying CMVs holds the lessee carrier 2015 final rule’s merger of the leasing time engaging multiple carriers or to directly responsible for violations of the and chartering concepts. In the 2017 turn to brokers. FMCSRs. proposal, FMCSA said that it intended While many commenters, including Comments: UMA consistently argued to revise subpart F of 49 CFR part 390 National Interstate Insurance, supported that FMCSA should not compel two or to exclude ‘‘chartering’’ from the leasing the exclusion of ‘‘chartering’’ from the more carriers, all possessing the requirements of that rule. requisite Federal operating authority, to Comments: UMA, Greyhound, leasing requirements of the rule, as stated in the 2017 proposal, some enter a lease they would not otherwise Academy Bus LLC, and others stated enter when engaging each other’s that the 2015 final rule is overly commenters, including Greyhound Lines, Inc., UMA, and Reston services. UMA believed that forcing burdensome to motor carriers. passenger-carriers into a lease would According to Coach USA Inc. and Limousine, wanted the Agency to clarify compel the assignment of inspection other commenters, the rule broadens the this term. In their joint request for an violations and crashes to the lessee. The term ‘‘lease’’ to capture charter and extension of time Adirondack commenter wrote that inspections and similar operations, thus placing Trailways, Pine Hill Trailways, and crashes should be attributed to the unnecessary burdens on compliant New York Trailways noted that the chartered, contracted, or subcontracted motor coach operators, while doing proposal equates ‘‘chartering’’ to carrier that possesses the sole, direct little to target the safety concern ‘‘subcontracting’’ in one section, but responsibility for compliance and associated with non-compliant carriers. then excludes the term ‘‘chartering’’ control of vehicle maintenance and Commenters believed FMCSA should from the entire rule. Reston Limousine driver qualifications and behavior. UMA exclude from the definition of ‘‘Lease’’ suggested defining ‘‘lease’’ to exclude in § 390.5 all passenger-carrying motor contracts, subcontracts, or charter wrote that the burden of the 2015 rule carriers that have FMCSA operating arrangements between two or more falls disproportionately on small-fleet authority. Specifically, they asked the passenger-carrying motor carriers with passenger carriers and disadvantages Agency to modify the definition of valid individual USDOT operating them by creating untenable regulatory ‘‘Lease’’ by clarifying that it does not authority. liability. include a ‘‘contract, subcontract, Coach USA commented that the FMCSA Response: Because Federal sublease, rental or charter arrangement administrative and paperwork burden operating authority and the practices of between two or more passenger-carrying associated with the full range of other the insurance industry both assign motor carriers where all parties have regulatory obligations related to responsibility to the operating motor operating authority.’’ chartering/subcontracting arrangements carrier, FMCSA agrees that there is no The Minnesota Charter Bus Operator’s would be prohibitive. Further, Coach need to reassign responsibility through Association stated that the rule would USA did not believe that it would be this rulemaking. As mentioned above, prohibit the necessary collaboration possible for a primary contractor to authorized carriers would not be subject among multiple operators to meet the obtain insurance for vehicles operated to this proposed rule when they use needs of large events that occur in by subcontractor, as the final rule seems vehicles or acquire transportation Minnesota. This commenter added that to require. Coach USA noted that it is services from other authorized carriers. the nature of the business requires not practicable for the primary carrier to FMCSA believes that this proposed operators to assist one another in the ensure that the subcontracting carrier is regulatory change would resolve the event of a mechanical breakdown, so in full compliance with many FMCSA objections and concerns of most they have to act quickly to service and regulations, particularly given that commenters, without impacting safety.

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Marking Requirements temporary markings required by of § 390.305 Notification, would not The 2015 final rule added a new § 390.21 and thought they would result apply. § 390.21(f) to cover the marking of in confusion. Academy Bus LLC noted that the 24- leased and interchanged passenger- Greyhound Lines Inc. urged FMCSA hour notice to customers was not carrying CMVs, as defined in § 390.5 (80 to exempt from the temporary marking addressed in the 2017 proposal and said FR 30178). Carriers operating such or placarding requirements the the issue was still of concern. Academy CMVs must meet certain standards for operation of vehicles that are being Bus LLC added that the industry is marking in § 390.21. They must also leased or interchanged between carriers required to be flexible and respond to display a placard, sign, or other that have FMCSA operating authority. the public demand on very short notice. permanent or removable device on the FMCSA Response: FMCSA proposes Coach USA believed that excluding right (curb) side of the passenger- to remove the 2015 final rule’s CMV chartering and subcontracting carrying CMV on or near the front marking requirements when a arrangements would also eliminate the passenger door. The device must show passenger-carrying CMV subject to the requirement to notify customers of the name and USDOT number of the proposed rule is leased or interchanged. subcontracting arrangements. Coach carrier operating the vehicle, preceded The Agency believes this proposed USA, however, supported a notification by the words ‘‘operated by,’’ e.g., regulatory change would resolve the requirement for carriers that had been ‘‘Operated by ABC Motorcoach, Inc., objections and concerns of the prohibited from operating by FMCSA or USDOT 12345678.’’ commenters. Under this NPRM, a motor a State and intended to lease, Comments: Industry commenters carrier operating a passenger-carrying interchange or otherwise convey use of generally argued that the 2015 final rule CMV under a lease having a term of not a vehicle to another carrier. In fact, imposes burdensome marking more than 30 calendar days could mark Coach USA argued that these carriers requirements that are impractical, and the CMV with either (1) the name and must provide written notice to FMCSA that there are less burdensome ways to USDOT identification number of the before taking such an action. address the Agency’s concerns. In their lessee, or (2) the name and USDOT FMCSA Response: FMCSA proposes joint request for extension of time, identification number of the lessor if, in to remove the lease notification Adirondack Trailways, Pine Hill the latter case, a fully complete lease is requirement, and believes its removal at Trailways, and New York Trailways carried on the leased CMV during the this time may alleviate unnecessary commented that ‘‘temporary markings’’ full term of the lease. These proposals regulatory burdens that, based on is a matter of particular importance to would remove the cost of additional available evidence, do not significantly them. They argued that the current final marking of the vehicles while aid travel groups in arranging trips or rules for temporary markings are maintaining all of the information avoiding particular carriers. If this unreasonable. They wrote that necessary for enforcement officials to conclusion is inaccurate, please provide compliance would be impractical or identify the carrier for regulatory data or information in regard to this unsafe, and arguably impossible, due to compliance. FMCSA proposes to add matter. paragraph (e)(2)(v) to allow a passenger- the design and construction of modern Expanding the 48-Hour Delay in carrying CMV operating under the 48- motor coaches. Preparing a Lease In its comments, Coach USA hour emergency exception pursuant to recommended that the Agency eliminate § 390.403(a)(2) to be excepted from When passengers are on a CMV and the requirement to change vehicle paragraphs (e)(2)(iii) and (iv) regarding an emergency occurs that requires a markings when vehicles are exchanged a lease document with required replacement vehicle from another motor between commonly owned carriers. information being carried on the carrier, § 390.303(a)(2) allows the two Coach USA wrote that changing vehicle, provided the lessor and lessee carriers to postpone writing a lease or markings on vehicles exchanged comply with the requirements of the other written agreement for up to 48 between commonly-owned Coach USA provision in § 390.403(a)(2). hours. The Agency believed the 48-hour window would provide ample time for companies would be highly burdensome Twenty-Four Hour Notice of Lease given the large number of such the parties to document the transaction. exchanges. Coach USA commented that If a motor carrier was originally hired One of the issues listed in the 2016 magnetic marking placards and paper to provide charter transportation of NOI was that FMCSA would reconsider signs are not a practical option. Placing passengers and subsequently expanding applicability of the 48-hour a sign on the inside of the bus could subcontracted this work to another delay provision for preparing a lease to obstruct the driver’s view and/or would motor carrier of passengers, the 2015 include emergencies when passengers not meet the legibility requirements due final rule required the original motor are not actually on board a bus (81 FR to window glare or window tinting. carrier to notify the tour operator or 59952, Aug. 31, 2016). FMCSA provided Coach USA also argued that requiring group of passengers within 24 hours examples of events that might require a vehicles interchanged between after hiring the subcontractor and motor carrier to obtain a replacement commonly-owned companies to be advising that the transportation would vehicle immediately: marked in accordance with § 390.21 is be provided by the subcontractor. The • Buses might be needed to transport likely to cause more confusion among 2016 NOI said that FMCSA was stranded passengers in the event that passengers than it resolves. It reported reconsidering that requirement based on Amtrak or airline service was that most of the vehicle exchanges petitioners’ arguments that the 24-hour suspended or disrupted. A bus operator between Coach USA carriers occur deadline is impractical in an emergency. contracted to provide emergency service between companies that have Comments: Industry commenters might need to obtain additional drivers ‘‘Megabus.com’’ written across their asked that the 24-hour requirement for and vehicles without delay; vehicles in huge letters. From the notification be clarified in a proposed • Last minute maintenance or public’s perspective, these rule. They also believed that excluding mechanical issues, or driver illness, motorcoaches are operated by Megabus. passenger carriers that have operating might arise late in the evening or during Coach USA did not believe that authority from the definition of ‘‘lease’’ the night (such as on a multi-day charter individuals would understand the in § 390.5 would mean the requirements or tour trip), or just prior to picking up

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a group for a charter or scheduled the regulatory exception that permits parties to the agreement, including the service run. the delayed writing of a lease during USDOT numbers and business In the 2017 proposal, FMCSA certain emergencies (e.g., a crash, the addresses. These summary documents explained that it intended to broaden vehicle is disabled) including when no would be produced upon the demand of the emergency 48-hour delay provision passengers are on the vehicle. Therefore, a law enforcement official. for preparing a lease authorized by 49 FMCSA proposes to move the exception In its request for an extension of time, CFR 390.303(a)(2) and remove the in 49 CFR 390.303(a)(2) to 49 CFR Coach USA argued that the information requirement that passengers actually be 390.403(a)(2). If a motor carrier obtains required in § 390.301(b)(2)(i) is trip on board a bus when the exception a replacement vehicle from, or specific, and would require the occurs. subcontracts for service with, another company to create a new summary Comments: In response to the 2017 motor carrier, the motor carriers may document for each of more than 10,000 proposal, industry commenters delay writing of a lease during these trips annually. Such a document would indicated that the expansion of the 48- emergency situations. However, a impose an unnecessary regulatory hour exemption could be addressed by summary document signed and dated by burden. Coach USA requested that the changing the definitions in § 390.5. the lessee’s driver or available company summary document required by this First, it was recommended that official must state: ‘‘[Carrier A, USDOT provision include only a ‘‘listing of all operations conducted under revenue number, telephone number] has leased members of the corporate family along pooling arrangements or common this vehicle to [Carrier B, USDOT with their USDOT numbers, business ownership and control be excluded number, telephone number] pursuant to addresses and contact telephone from the definition of ‘‘interchange’’ in 49 CFR 390.403(a)(2)’’ and the summary numbers.’’ The company also asked the § 390.5. Second, FMCSA was asked to document must be carried on the Agency to clarify that any summary exclude passenger motor carriers from replacement vehicle for the duration of document may be maintained in the definition of ‘‘lease’’ in § 390.5 when the lease. Enforcement officials will be electronic format and stored on an all parties have operating authority. able to use this summary document to electronic logging device. Academy Bus LLC was concerned about determine the identity of the carrier In its response to the Agency’s 2017, lease preparation issues, noting that responsible for regulatory compliance. proposal, Coach USA, like other ‘‘Our industry, by its nature, is required industry commenters, reiterated its to be flexible and respond to the public Summary Document Requirements in § 390.301(b)(2) and (3) previous comments. demand on very short notice.’’ FMCSA Response: Since this An individual believed that the 48- In § 390.301(b)(2), the 2015 rule proposed rule would not apply to hour time period for preparing leases allows passenger-carrying CMVs to be transactions between or among might be a good idea for the trucking exchanged or interchanged without authorized carriers under the proposed industry, but that is not the case for leases or receipts among commonly exception in § 390.401(b)(1) Contracts passenger carriers. This commenter owned and controlled motor carriers, and agreements between motor carriers stated that at peak times ‘‘every worker provided the driver carries and of passengers with active passenger is stretched thin and there is a need to produces, upon demand of a Federal, carrier operating authority registrations, bring in more operators to provide the State, or local law enforcement official, FMCSA believes that regulatory same services,’’ otherwise customers a summary document listing certain exceptions for commonly owned and may be left stranded. In these instances, information [see 80 FR at 30179]. controlled carriers, and carriers Section 390.301(b)(3) provides that it is ‘‘an emergency to both the busing participating in STB-approved revenue companies and the customers to bring in passenger-carrying CMVs may be pooling agreements, are no longer another operator to provide the exchanged or interchanged without necessary. The industry commenters necessary backup to complete the job in leases or receipts among motor carriers suggested making the rule inapplicable an efficient manner. To combat this that are party to a revenue pooling to commonly owned and controlled situation, companies need to work agreement approved by the Surface carriers and carriers participating in together before, during and after leasing Transportation Board (STB) provided STB-approved revenue pooling passenger vehicles.’’ This commenter that the driver carries and, upon agreements, and the Agency agrees with also recommended that accountability demand of a Federal, State, or local law these comments. Therefore, FMCSA be placed directly on the subcontractor enforcement official, displays other proposes to rescind the exceptions in 49 and its driver. information, including a summary CFR 390.303(b)(2) and (b)(3). All Coach USA wrote that the exception document [see 80 FR at 30179]. in 49 CFR 390.303(a)(2) would likely Neither the 2016 NOI nor the 2017 passenger carriers that are commonly apply only in rare instances if FMCSA proposal addressed the summary owned and controlled or participate in exempted chartering and subcontracting document requirements. STB-approved revenue pooling arrangements from the regulations. Comments: The industry commenters agreements operate in interstate Coach USA supported extending the 48- suggested removing the requirements in commerce and have operating authority. hour delay to cases of emergencies § 390.301(b)(2) and (3) and instead An authorized carrier that obtains a where passengers are not yet on the bus. including language about an abbreviated vehicle from another commonly owned Because operators will likely not have summary document in the definition of and controlled authorized carrier or time to mark vehicles in the event of an ‘‘interchange’’ in § 390.5. If the another participant in an STB-approved emergency that requires replacement of interchange occurred among commonly pooling agreement, would not be subject a vehicle on very short notice, Coach owned/controlled motor carriers, the to this proposed rule. USA proposed eliminating the final summary document would identify the VII. General Discussion of the Proposed sentence of § 390.303(a)(2), ‘‘The lessee carriers in that ‘‘family,’’ including Rule must also mark the vehicle in USDOT numbers and business accordance with § 390.21(f) before addresses. If the interchange occurred A. The Proposed Rule operating it.’’ pursuant to a revenue pooling FMCSA proposes removing and FMCSA Response: FMCSA adopts the agreement approved by the STB, the reserving subpart F of part 390, moving petitioners’ recommendation to expand summary document would identify the it to subpart G with the same title,

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‘‘Lease and Interchange of Passenger- CMVs. For a lease of 30 calendar days § 390.303(a)(1)(iii), which covers written Carrying Commercial Motor Vehicles,’’ or less, the lessee can opt to mark the agreements governing the renting, and making some further regulatory vehicle with either the lessee’s borrowing, loaning, or similar transfer of changes discussed later in this information or the lessor’s information. a passenger-carrying CMV from another document. FMCSA is planning to use However, the latter would require a party. The rule would be revised and subpart F in a future NPRM to be fully executed copy of the lease be moved to § 390.403(a)(1) to include such published under RIN 2126–AB56, carried on the vehicle. transactions as either a lease or Unified Registration System If the motor carrier is operating a interchange, which makes paragraph Enhancements and Updates. passenger-carrying CMV under a lease (a)(1)(iii) unnecessary. FMCSA is or rental agreement for more than 30 proposing to expand the emergency- Definitions calendar days, such CMV must be related exception in § 390.303(a)(2) The Agency proposes to revise the marked with the lessee’s identification (after transferring it to § 390.403(a)(2)) definition of lease in § 390.5 to include information. In a lease situation, the that allows the postponement of the only contracts and agreements in which operating motor carrier is the lessee. completion of a lease for up to 48 hours a motor carrier grants the use of a These revised regulations would for situations, such as a crash or vehicle passenger-carrying CMV to another address petitioners’ concerns that there breakdown, when a replacement vehicle motor carrier when at least one of the is no easy way to display a temporary must be immediately obtained from motor carriers is not an authorized marking on certain passenger-carrying another motor carrier. Industry carrier.5 Authorized carriers routinely motor vehicles for short term leases. commenters requested this expansion of assist one another by providing FMCSA specifically requests comments the limited exception and FMCSA transportation services during demand from State Agencies that participate in agrees with them. FMCSA proposes to surges, emergencies, or events that the Motor Carrier Safety Assistance allow the exception even when require more than their available Program about the effectiveness of these passengers are not on the bus. capacity. These common agreements, proposed marking regulations for leased Section 390.403(b) specifies the some of which amount to passenger-carrying CMVs and any contents of lease and interchange subcontracting, would not meet the potential inspection or enforcement documents. This paragraph requires the regulatory definition of a lease in this problems. lease, interchange agreement, or other agreement to contain: (1) The name of proposed rule. Authorized carriers that General Applicability and Exceptions are hired by another authorized carrier the vehicle manufacturer, the year of have traditionally assumed The general applicability section manufacture, and the last 6 digits of the responsibility for their own regulatory would be revised slightly to reflect the Vehicle Identification Number; (2) the compliance and liability. This practice removal of exceptions in paragraph (b). legal names, contact information, and has long been acceptable to the Section 390.401(b) would be modified signatures 6 of both parties; (3) the time insurance industry. Furthermore, in several ways. First, a new exception and date when the lease begins and authorized carriers are readily would appear in paragraph (b)(1) to ends; and (4) a statement that the lessee identifiable to enforcement personnel, exclude from the rule contracts and has exclusive possession and control of agreements between passenger carriers making a separate lease agreement the leased vehicle and is responsible for with active operating authority when assigning regulatory responsibility regulatory compliance. one such carrier acquires transportation unnecessary. Current § 390.303(b)(4)(i)–(iii) is a The definition of lease would become services from another such carrier. slightly revised version of 49 CFR narrower by including only contracts Second, the current exception for 376.12(c)(1), (2) and (4). Paragraph and agreements to grant the use of a financial leases in paragraph (b)(4)(i) is essential because it sets forth passenger-carrying CMV between motor § 390.301(b)(1) would be moved to the basic reason for a lease, from carriers when one (or more) such carrier paragraph § 390.401(b)(2) as an FMCSA’s point of view, to assign full does not have operating authority. The exception with a revision. The provision responsibility for regulatory compliance term lease would also be revised with that the financial organization, to the lessee. FMCSA proposes to make added language to include manufacturer, or dealer must not be a this paragraph more concise. Current circumstances when no compensation is motor carrier to utilize the exception paragraph (b)(4)(ii) would be moved to specified. The terms lessee and lessor from the rule is proposed for removal § 390.403(b)(4)(ii) and would retain only would both be revised slightly to specify because such entities are motor carriers the last sentence of that provision. that the granting of passenger-carrying when they move their vehicle inventory Paragraph (b)(4)(iii) is a useful CMV usage is through a lease. between business locations before disclaimer, should the issue of status of purchases. Third, the limited exception the lessor (contractor or employee) arise Marking of Self-Propelled CMVs and in paragraph (b)(2) for passenger- in a tax context, but FMCSA does not Intermodal Equipment carrying CMVs exchanged or believe it is essential. Therefore, Section 390.21 (suspended) and interchanged between or among FMCSA proposes to shorten paragraphs 390.21T would be returned nearly to the commonly owned and controlled motor (b)(4)(i) and (b)(4)(ii) and remove form before the March 27, 2015, final carriers would be removed. Fourth, the paragraph (b)(4)(iii). rule. FMCSA would remove the special limited exception in paragraph (b)(3) for FMCSA proposes to remove the marking regulations for leased and passenger-carrying CMVs exchanged or requirement in § 390.303(b)(5) that the interchanged passenger-carrying CMVs interchanged between or among motor lease contain a statement that the lessee in paragraph (f). Section 390.21 carriers that are a party to a revenue is responsible for compliance with the (suspended) and 390.21T would be pooling agreement approved by the STB revised to treat leased passenger- in accordance with 49 U.S.C 14302 6 FMCSA allows the use of electronic signatures would also be removed. in accordance with the Government Paperwork carrying CMVs like all other rented Elimination Act (Pub. L. 105–277, Title XVII, Secs. Lease and Interchange Requirements 1701–1710, 44 U.S.C. 3504 note, 112 Stat. 2681– 5 This rulemaking does not propose a change to 749). See 76 FR 411, Jan. 4, 2011 and the Electronic the definition of lease in the context of property- Lease and interchange requirements Signature final rule’s §§ 390.5, 390.5T, and 390.32, carrying vehicles in 49 CFR 376.2. would be revised by removing April 16, 2018 (83 FR 16226–7).

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insurance requirements of 49 CFR part authorized carrier B that has the pays carrier B for the transportation 387. necessary capacity. Carrier A may or service. This arrangement is not a lease, Section 390.303(c) and (d) would be may not pay a fee to carrier B for taking first because carrier B is not granting the merged and made more concise. Revised over the contract. A complete transfer use of a passenger-carrying CMV to § 390.403(c) would state that a copy of would require carrier A to cancel its carrier A, and second because both the lease must be carried in the contract with the customer and carrier carriers are authorized carriers. This passenger-carrying CMV during the B to create a new contract with the arrangement is also not an interchange period of the lease or interchange customer. The proposed rule would not because carriers A and B are not agreement. Both the lessee and lessor apply to these transactions because conducting a through movement. The would retain the lease or interchange these transactions do not qualify as a proposed rule would not apply to this agreement for 1 year afterwards. ‘‘lease’’ (or interchange), as defined in arrangement. Carrier B will conduct the Section 390.303(e) would be removed. § 390.5, of a passenger-carrying CMV. transportation in its own name, on its FMCSA has decided it does not need own authority, with its own vehicle(s), Complete Subcontracting Among receipts when vehicles are surrendered and is therefore responsible for Authorized Carriers to the lessee and returned to the lessor. compliance with the FMCSRs. If FMCSA or another government Authorized carrier A lacks the enforcement agency sought to assign a capacity to execute a contracted trip and Other Business Arrangements Between safety incident to the lessee or the lessor hires authorized carrier B to make the Passenger Carriers based on a lease or other agreement that trip while maintaining its contract with Example 1 had already been terminated, the former the customer. This arrangement is Carrier A is exempt under 49 U.S.C. parties to the lease would have to documented by a charter contract 13506 from the requirement for decide how to document that premature between carriers A and B. Carrier A operating authority—for example, termination. pays carrier B for the trip. This because of the hotel exemption in FMCSA proposes to remove the arrangement is not a lease, first because section 13506(a)(3) 8—but finds itself requirements in § 390.303(f) for carrier B is not granting the use of a without the capacity to accommodate a additional temporary markings of leased passenger-carrying CMV to carrier A, group that it originally intended to and interchanged passenger-carrying and second because both carriers are transport. When this occurs, carrier A CMVs, and to return to the text of the authorized carriers. Instead, carrier B is 7 hires authorized carrier B to provide marking rule in § 390.21(e) that was making the trip in its own name, on its charter passenger transportation of the effective on July 1, 2015, with slight own authority, with its own vehicles group in whole or in part. This modifications. The modifications would and is therefore responsible for arrangement is documented by a charter add references to leased CMVs in compliance with the FMCSRs. The contract between carriers A and B. paragraph (e) to provide a similar option proposed rule therefore would not apply Carrier A pays carrier B for the to rented CMVs. to this arrangement. transportation service, but is not a lessee FMCSA believes that this eliminates of carrier B’s vehicle. Therefore, this one of petitioners’ major objections to Partial Subcontracting Among arrangement is not a lease. Carrier B the 2015 final rule. The proposed rule Authorized Carriers does not claim the exemption in section would require a leased passenger- Assuming the same facts as described 13506(a)(3) but conducts the carrying CMV be marked with the above, except that authorized carrier A transportation in its own name, on its lessee’s identification information if the provides some of the transportation own authority, with its own vehicle(s) lease is longer than 30 days. Leased service while contracting with and is therefore responsible for passenger-carrying CMVs would be authorized carrier B for the remainder, compliance with the FMCSRs. The required to be marked with either the this arrangement is not a lease, first proposed rule would not apply to this lessor’s or lessee’s identification because carrier B is not granting the use arrangement. information if the lease is 30 days or of a passenger-carrying CMV to carrier less. A, and second because both carriers are Example 2 Finally, the proposed rule removes authorized carriers. Carrier A pays Private motor carrier of passengers A the requirement in § 390.305 to notify carrier B for the transportation service finds itself without the capacity to the passenger group or their as part of a charter contract. Carrier B transport the members of its representative within 24 hours after the is not surrendering control of a organization. Carrier A therefore hires primary contractor reassigns the passenger-carrying CMV to carrier A for authorized carrier B to provide charter transportation to a subcontractor. its own use. Both carriers are authorized passenger transportation of the group in B. Examples of Proposed Rule carriers providing transportation in their whole or in part. This arrangement is Implementation own name, on their own authority, with documented by a charter contract their own vehicles, and each is between carriers A and B. Carrier A The following examples illustrate the independently responsible for pays carrier B for the transportation proposed application of this compliance with the FMCSRs. service. Carrier A is not a lessee and the rulemaking: Subcontracting Among Regular Route arrangement is not a lease or Complete Contract Transfer Example Authorized Carriers interchange because carrier B conducts Authorized carrier A is contracted to the transportation in its own name, on Authorized carrier A, which provides its own authority, with its own transport a tour or travel group on a trip, regular route passenger transportation but finds itself without the capacity to vehicle(s) and is therefore responsible services according to a fixed schedule, for compliance with the FMCSRs. The accommodate the group. Carrier A finds itself without the capacity to completely transfers the contract to execute a route. Carrier A hires 8 Section 13506 lists the miscellaneous motor authorized carrier B to continue this carrier transportation exemptions. Under section 7 See e-CFR text in effect on July 1, 2015 at service. This arrangement is 13506(a)(3), neither the Secretary nor the Board has https://www.ecfr.gov/cgi-bin/text-idx?SID= jurisdiction over a motor vehicle owned or operated b9ddca68b462ed0f3d5758839de97752&pitd=20150 documented by a charter contract by or for hotel patrons between the hotel and the 701&node=pt49.5.390&rgn=div5#se49.5.390_121. between carriers A and B. Carrier A local station of a carrier.

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proposed rule would not apply to this provided by carrier B, and is therefore IX. Section-by-Section Description of arrangement. responsible for compliance with the the Proposed Rule Example 3 FMCSRs. A. Section 390.5 (Suspended) and Carrier A is an exempt for-hire motor Example 6 390.5T Definitions carrier of passengers (under 49 U.S.C. Section 390.5 (suspended) and 390.5T Private motor carrier of passengers A 13506) that finds itself without the would be amended to revise the finds itself without the capacity to capacity to accommodate a group it definitions of lease, lessee, and lessor transport the members of its originally intended to transport. Carrier and all of these terms would apply organization and uses a passenger- A uses a passenger-carrying CMV specifically to motor carriers of carrying CMV owned by private motor owned by authorized carrier B. This passengers. transaction is a lease under the carrier of passengers B. This transaction proposed rule and would be subject to is a lease under the proposed rule and B. Section 390.21 (Suspended) and its requirements because carrier A is not would be subject to the requirements of 390.21T Marking of Self-Propelled authorized to operate for-hire in this rule because neither carrier has the CMVs and Intermodal Equipment interstate commerce. In this case, carrier authority to conduct for-hire operations Section 390.21 (suspended) and B is a lessor that is surrendering control in interstate commerce. In this case, 390.21T would be returned nearly to the of a passenger-carrying CMVs to carrier carrier B is a lessor that is surrendering form before the March 27, 2015, final A for the use of that carrier. Carrier A control of its passenger-carrying CMV to rule. In the paragraph (e) header, will conduct the transportation in its carrier A for the use of that carrier. FMCSA replaces ‘‘Rented property- own name under its own safety Carrier A will conduct the carrying commercial motor vehicles’’ registration (i.e., USDOT number) with transportation in its own name, under with the header phrase ‘‘Rented CMVs the CMV leased from carrier B, with or its own safety registration (i.e., USDOT and leased passenger-carrying CMVs.’’ without drivers provided by carrier B, number), with the CMV leased from Throughout paragraph (e), the Agency and is therefore responsible for carrier B, with or without drivers adds the phrase ‘‘or lease’’ after the term compliance with the FMCSRs. provided by carrier B, and is therefore ‘‘rental agreement.’’ When referring to a Example 4 responsible for compliance with the ‘‘renting motor carrier,’’ the Agency applicable FMCSRs. adds the phrase ‘‘or lessee’’ immediately Private motor carrier of passengers A after it. In paragraph (e)(2)(iv), in Example 7 finds itself without the capacity to addition to the cross reference to the accommodate a group it originally property-carrying leasing regulations in intended to transport. Carrier A uses a For-hire passenger carrier A had its operating authority revoked for lack of 49 CFR part 376, FMCSA adds a cross passenger-carrying CMV owned by reference to the passenger-carrying authorized carrier B. This transaction is adequate insurance coverage. Carrier A wishes to generate revenue from its leasing regulations in subpart G of part a lease under the proposed rule and 390 so that the revised sentence reads would be subject to its requirements otherwise idle CMVs. It therefore negotiates an arrangement with ‘‘See the property-carrying leasing because carrier A is not authorized to regulations at 49 CFR part 376 and the operate for-hire in interstate commerce. authorized carrier B to surrender control of its passenger-carrying CMVs to carrier passenger-carrying leasing regulations at In this case, carrier B is a lessor that is subpart G of this part for information surrendering control of a passenger- B for a fee. This arrangement is a lease under the proposed rule and would be that should be included in all leasing carrying CMVs to carrier A for the use documents.’’ FMCSA proposes to add subject to its requirements because of that carrier. Carrier A will conduct paragraph (e)(2)(v) to allow the carrier A is not authorized to operate the transportation in its own name passenger-carrying CMV operating for-hire in interstate commerce. In this under its own safety registration (i.e., under the 48-hour emergency exception case, carrier A is simply a lessor. Carrier USDOT number) with the CMV leased pursuant to § 390.403(a)(2) to be B would conduct the transportation in from carrier B, with or without drivers excepted from paragraphs (iii) and (iv) provided by carrier B, and is therefore its own name, on its own authority, regarding a lease document with responsible for compliance with the with the CMVs leased from carrier A, required information being carried on applicable FMCSRs. with or without drivers provided by the vehicle, provided the lessor and carrier A, and is therefore responsible Example 5 lessee comply with the requirements of for compliance with the FMCSRs. Authorized carrier A lacks the the provision in § 390.403(a)(2). capacity to execute a contracted trip and C. Alternatives In paragraph (f), FMCSA would uses a passenger-carrying CMV owned remove the special marking regulations FMCSA requests comments to by private motor carrier of passengers, for leased and interchanged passenger- identify other methods to achieve the carrier B. This transaction is a lease carrying CMVs. This proposal would under the proposed rule and would be safety objectives of this rulemaking. redesignate paragraphs (g) and (h) as paragraphs (f) and (g), respectively, as subject to its requirements because VIII. International Impacts 9 private carrier B is not authorized to they were on July 1, 2015. operate for-hire in interstate commerce The FMCSRs, and any exceptions to C. Part 390, Subpart F Lease and and cannot be hired to provide the FMCSRs, apply only within the Interchange of Passenger-Carrying transportation. In this case, carrier B is United States (and, in some cases, Commercial Motor Vehicles a lessor that is surrendering control of United States territories). Motor carriers Subpart F, including §§ 390.301, its passenger-carrying CMV to carrier A. and drivers are subject to the laws and 390.303, and 390.305, would be Carrier A will conduct the regulations of the countries in which removed and reserved. transportation in its own name, under they operate, unless an international agreement states otherwise. Drivers and its own authority, with the CMV leased 9 See https://www.ecfr.gov/cgi-bin/text-idx?SID= from the private motor carrier of carriers should be aware of the b9ddca68b462ed0f3d5758839de97752&pitd=20150 passengers, with or without drivers regulatory differences among nations. 701&node=pt49.5.390&rgn=div5#se49.5.390_121.

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D. Part 390, Subpart G Lease and X. Regulatory Analyses representing a decrease in cost or a cost Interchange of Passenger-Carrying savings. A. E.O. 12866 (Regulatory Planning and Commercial Motor Vehicles Review), E.O. 13563 (Improving Key Inputs to the Analysis Subpart G, consisting of §§ 390.401 Regulation and Regulatory Review), and DOT Regulatory Policies and Procedures The proposed rule revises regulations and 390.403, would be added. established in the 2015 final rule, FMCSA performed an analysis of the E. Section 390.401 Applicability therefore the 2015 final rule serves as impacts of the proposed rule and the baseline against which the effects of Paragraph (a) would add the general determined it is not a significant the proposed rule are evaluated. Many applicability for passenger-carrying regulatory action under section 3(f) of of the key inputs to this analysis of the CMV leases and interchanges as the E.O. 12866 (58 FR 51735, October 4, proposed rule are based on the same terms ‘‘lease’’ and ‘‘interchange’’ would 1993), Regulatory Planning and Review, data sources and methods as those be defined in this proposal’s §§ 390.5 as supplemented by E.O. 13563 (76 FR developed and used in the evaluation of (suspended) and 390.5T. 3821, January 21, 2011), Improving the 2015 final rule, with various updates Regulation and Regulatory Review. made as needed to reflect more recently Paragraph (b) would provide the two Accordingly, the Office of Management proposed exceptions to the general rule. available data and information. and Budget (OMB) has not reviewed it Therefore, a copy of the regulatory Paragraph (c) would provide that if the under that Order. It is also not use of a passenger-carrying commercial evaluation for the 2015 final rule is significant within the meaning of DOT available in the docket for the proposed motor vehicle is conferred between regulatory policies and procedures rule, and, where applicable, the Agency motor carriers subject to this proposal (DOT Order 2100.5 dated May 22, 1980; and either carrier fails to meet all cites that document in the analysis 44 FR 11034 (February 26, 1979)). 10 applicable requirements of subpart G, As described earlier, the proposed below. A 10-year analysis period of both motor carriers shall be subject to a rule would reduce the scope of the lease 2019 to 2028 is utilized for this analysis civil penalty. and interchange requirements for motor of the proposed rule, and all monetary values are expressed in 2016 dollars. F. Section 390.403 Lease and carriers of passengers. Furthermore, Interchange Requirements those passenger carriers and passenger- Number of Passenger Carriers carrying CMV trips for which the Experiencing Regulatory Relief Under In paragraph (a)(1), this proposal proposed rule would remain applicable the Proposed Rule would set out the two instances in would be subject to lease and which a lease or other agreement is interchange requirements that are The Agency estimates that an annual required (and the lease or agreement reduced in comparison to those of the average of 8,215 motor carriers of must then meet the conditions of 2015 final rule. At the same time, passengers would experience regulatory paragraphs (b) and (c) of this section). In FMCSA believes that the lease and relief under the proposed rule, as paragraph (a)(2), this proposal would interchange requirements of the discussed below. This represents the allow the delayed writing of a lease after proposed rule would still enable safety average over the 10-year analysis period an emergency, such as a disabled officials and the general public to of the individual annual estimates of the vehicle, that disrupts or delays a trip, sufficiently identify the passenger total number of passenger carriers and would not limit the exception to carrier responsible for safety. As a experiencing regulatory relief under the times when passengers are on the bus. consequence, FMCSA estimates that the proposed rule, which are presented in proposed rule would result in a cost Table 2. As also shown in Table 2, the Paragraph (b) would specify the four savings, but would not result in any Agency estimates that approximately 75 minimum required items of any lease, change to safety benefits. percent of this total number of sublease, or interchange document The Agency estimates that the passenger carriers would experience full required under this proposal: (1) Vehicle proposed rule would result in a cost regulatory relief and would no longer be identification information; (2) Parties; savings of $75.1 million on an subject to the lease and interchange (3) Specific duration; and (4) Exclusive undiscounted basis, $66.5 million requirements for passenger-carrying possession and responsibilities. discounted at 3 percent, and $57.5 CMVs as a consequence of the proposed Paragraph (c) would provide when a million discounted at 7 percent over the rule. The remaining 25 percent of these copy of the lease must be on the 10-year analysis period. Expressed on passenger carriers would experience passenger-carrying CMV and how long an annualized basis, this equates to a partial regulatory relief and remain both the lessor and lessee must retain 10-year cost savings of $7.8 million at a subject to reduced lease and interchange copies of the lease, sublease, or 3 percent discount rate and $8.2 million requirements compared to those of the agreement. at a 7 percent discount rate, again 2015 final rule.

TABLE 2—ESTIMATED NUMBER OF PASSENGER CARRIERS EXPERIENCING REGULATORY RELIEF UNDER THE PROPOSED RULE

Passenger Passenger Total passenger carriers carriers carriers experiencing experiencing experiencing Year full regulatory partial regulatory regulatory relief under the relief under the relief under the proposed rule proposed rule proposed rule

2019 ...... 5,929 1,977 7,906 2020 ...... 5,980 1,993 7,973

10 DOT FMCSA, ‘‘Lease and Interchange of Vehicles, Motor Carriers of Passengers, 2015 Final Rule Regulatory Evaluation.’’

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TABLE 2—ESTIMATED NUMBER OF PASSENGER CARRIERS EXPERIENCING REGULATORY RELIEF—Continued UNDER THE PROPOSED RULE

Passenger Passenger Total passenger carriers carriers carriers experiencing experiencing experiencing Year full regulatory partial regulatory regulatory relief under the relief under the relief under the proposed rule proposed rule proposed rule

2021 ...... 6,031 2,010 8,041 2022 ...... 6,082 2,027 8,109 2023 ...... 6,134 2,044 8,178 2024 ...... 6,185 2,062 8,247 2025 ...... 6,238 2,079 8,317 2026 ...... 6,290 2,097 8,387 2027 ...... 6,344 2,115 8,459 2028 ...... 6,397 2,133 8,530

Annual average ...... 6,161 2,054 8,215

To derive the estimates presented in available data and information. Data carriers would be subject to the May Table 2 of the number of passenger from the FMCSA Motor Carrier 2015 final rule. This estimate is based carriers experiencing regulatory relief Management Information System on the same methods as those under the proposed rule, FMCSA first (MCMIS) and the FMCSA Licensing and developed and used in the evaluation of estimated the number of passenger Insurance (L&I) system were used to the 2015 final rule, and assumes that carriers that, in the absence of the develop a new baseline value for the under that rule 100 percent of proposed rule, would be affected by the reported number of all active interstate authorized for-hire carriers, 100 percent lease and interchange requirements of passenger carriers operating in the U.S. of exempt for-hire carriers, and 10 the 2015 final rule. This estimate is as of the end of calendar year 2017, percent of private passenger carriers 12 13 based on the same data sources and namely 13,386 carriers. would be subject to the lease and methods as those developed and used in Of this total population, the Agency interchange requirements for passenger- the evaluation of the 2015 final rule 11 estimates that, in the absence of the carrying CMVs.14 but updated to reflect more recently proposed rule, 7,774 of these passenger

TABLE 3—REPORTED NUMBER OF ACTIVE INTERSTATE PASSENGER CARRIERS OPERATING IN THE U.S. (AS OF DECEMBER 29, 2017), AND ESTIMATED NUMBER THAT WOULD BE SUBJECT TO THE MAY 2015 FINAL RULE IN THE ABSENCE OF THE PROPOSED RULE

Number (and percent) estimated to be subject Type of passenger carrier operation Total number to the May 2015 final rule of carriers in the absence of the proposed rule

Authorized For-Hire (a) ...... 6,629 6,629 (100% of total). Exempt For-Hire (9+) (b) ...... 340 340 (100% of total). Exempt For-Hire (16+) (c) ...... 181 181 (100% of total). Private (business) (d) ...... 2,599 260 (10% of total). Private (non-business) (e) ...... 3,637 364 (10% of total).

Total (f) ...... 13,386 7,774. Notes: (a) A commercial entity whose primary business activity is the transportation of passengers by motor vehicle for compensation. (b) A for-hire entity that is exempt under 49 U.S.C. 13506, and operates at least one passenger vehicle designed or used to accommodate 9 or more passengers including the driver. (c) A for-hire entity that is exempt under 49 U.S.C. 13506, and operates at least one passenger vehicle designed or used to accommodate 16 or more passengers including the driver. (d) A private entity engaged in the interstate transportation of passengers which is provided in the furtherance of a commercial enterprise and is not available to the public at large. (e) A private entity involved in the interstate transportation of passengers that does not otherwise meet the definition of a ‘‘private (business)’’ motor carrier of passengers as noted above.

11 Further details regarding the specific data (L&I) system. Snapshots as of December 29, 2017 to not risk underestimating the number of affected sources and methods can be found in DOT FMCSA, (DART request ID #38883). passenger carriers and the corresponding cost of the ‘‘Lease and Interchange of Vehicles, Motor Carriers 13 The total number of 13,386 passenger carriers lease and interchange requirements of the May 2015 of Passengers, 2015 Final Rule Regulatory as of the end of 2017 actually represents 11,705 final rule. Evaluation.’’ Pages 9–12. unique carriers, because some carriers provide 14 DOT FMCSA, ‘‘Lease and Interchange of 12 U.S. Department of Transportation (DOT), passenger service in more than one of the operation Federal Motor Carrier Safety Administration classifications shown. Consistent with the approach Vehicles, Motor Carriers of Passengers, 2015 Final (FMCSA). Motor Carrier Management Information used in the regulatory evaluation for the May 2015 Rule Regulatory Evaluation.’’ Pages 9–12. System (MCMIS), and Licensing and Insurance final rule, the larger number was used here so as

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(f) The total number of 13,386 passenger carriers shown actually represents 11,705 unique carriers, because some carriers provide passenger service in more than one of the operation classifications shown. Consistent with the approach used in the regulatory evaluation for the May 2015 final rule, the larger number was used here so as to not risk underestimating the number of affected passenger carriers and the corresponding cost of the lease and interchange requirements of the May 2015 final rule.

The 2017 value of 7,774 passenger For exempt for-hire carriers and regulatory relief. As noted earlier, carriers that would be subject to the private passenger carriers, the analysis however, these carriers would be subject 2015 final rule was then used as the assumes that 100 percent and 10 to reduced requirements compared to basis to develop future projections over percent, respectively, of these carriers those of the 2015 final rule. the 2019 to 2028 analysis period. These would continue to be subject to the FMCSA requests comments and projections were developed by lease and interchange requirements submission of quantitative or qualitative increasing the baseline 2017 value of under the proposed rule, the same data addressing the potential number of 7,774 passenger carriers consistent with percentages as under the 2015 final rule passenger carriers that would the occupation-specific employment and also as shown in Table 3. experience regulatory relief under the growth projections for Standard Combined, these changes result in an proposed rule. Occupational Classification (SOC) Code estimated overall reduction of Number of CMV Trips Experiencing 53–3021 (Bus drivers, transit and approximately 75 percent in the number Regulatory Relief Under the Proposed intercity) obtained from the Bureau of of passenger carriers subject to lease and Rule Labor Statistics (BLS) Employment interchange requirements under the Projections Program which, from 2016 proposed rule.16 This reduction is The Agency estimates that an annual to 2026, is forecast to grow by 0.85 consistent with the comments and average of 537,134 passenger-carrying percent annually.15 This results in a petitions for reconsideration that the CMV trips would experience regulatory projection of the number of passenger Agency received, a number of which relief under the proposed rule over the carriers that, in the absence of the suggested that the scope of the 2015 10-year analysis period, as presented in proposed rule, would be subject to the final rule likely encompassed a Table 4 and discussed below. This 2015 rule each year over the 2019 to relatively large proportion of passenger- estimate is based on the same methods 2028 analysis period. In the absence of carrying CMV trips in which both the as those developed and used in the the proposed rule, all of these passenger lessor and the lessee were authorized evaluation of the 2015 final rule.17 The carriers would be subject to the 2015 carriers. Petitioners generally argued estimated number of passenger carriers rule. As discussed earlier, under the that such carriers should not be subject that would experience regulatory relief proposed rule a large portion of these to lease and interchange requirements. under the proposed rule (see Table 2) passenger carriers would no longer be Finally, Table 2 also presents an serves as the primary basis for the subject to lease and interchange estimate of the remaining subset of the estimate of the number of trips that requirements, and the remaining annual average of 8,215 passenger would experience regulatory relief carriers would be subject to reduced carriers that would experience partial under the proposed rule. For each of the requirements. In Table 2, the column on regulatory relief and remain subject to carriers in Table 2, we assumed an the far right shows the projected number reduced lease and interchange estimated average of 64 trips per year of passenger carriers that would requirements compared to those of the are operated with leased or experience regulatory relief under the 2015 rule. Over the 10-year analysis interchanged vehicles. This is consistent proposed rule over the 10-year analysis period, the Agency estimates that an with the assumptions used in the period of 2019 to 2028, which equals an annual average of 2,054 passenger regulatory evaluation for the 2015 final annual average of 8,215 passenger carriers, or approximately 25 percent of rule.18 The estimated number of trips carriers. the total, would experience partial that would experience regulatory relief Table 2 also shows the subset of those under the proposed rule (see Table 4) 16 As shown in Table 3, in 2017 an estimated also incorporates a modest upward 8,215 passenger carriers that under the 7,774 passenger carriers would be subject to the proposed rule would experience full lease and interchange requirements of passenger- adjustment to reflect an annual average regulatory relief and would no longer be carrying CMVs under the May 2015 final rule. of 11,400 trips operated by Greyhound, subject to lease and interchange Under the proposed rule, as noted, the analysis one of the largest U.S. interstate assumed that only 10 percent of authorized for-hire passenger carriers. This adjustment is requirements. Over the 10-year analysis carriers would be subject to the lease and period, the Agency estimates that an interchange requirements of passenger-carrying consistent with the methods used in the annual average of 6,161 passenger CMVs, or 10 percent of 6,629, which equals 663 evaluation of the 2015 final rule,19 and authorized for-hire passenger carriers. The analysis is based on data that was provided to carriers, or approximately 75 percent of also assumed that 100 percent of exempt for-hire the total number of carriers that would carriers and 10 percent of private passenger carriers FMCSA by Greyhound regarding trips experience regulatory relief, would would continue to be subject to the lease and with leased and interchanged vehicles experience full regulatory relief. This interchange requirements for passenger-carrying in 2012.20 value was estimated by assuming that CMVs under the proposed rule, which equals 100 percent of 340 and 181 exempt for-hire carriers 17 DOT FMCSA, ‘‘Lease and Interchange of approximately 10 percent of authorized (totaling 521 exempt for-hire carriers), and 10 Vehicles, Motor Carriers of Passengers, 2015 Final percent of 2,599 and 3,637 private carriers (totaling for-hire carriers would be subject to the Rule Regulatory Evaluation.’’ Page 21, Table 6. 624 private carriers). Therefore, the Agency lease and interchange requirements 18 estimates that 1,808 passenger carriers would be DOT FMCSA, ‘‘Lease and Interchange of under the proposed rule, rather than 100 subject to the lease and interchange requirements of Vehicles, Motor Carriers of Passengers, 2015 Final percent as assumed previously under passenger-carrying CMVs in 2017 under the Rule Regulatory Evaluation.’’ Page 21, Table 6. the 2015 final rule and as shown in proposed rule, or 23.3 percent of those subject to 19 DOT FMCSA, ‘‘Lease and Interchange of Vehicles, Motor Carriers of Passengers, 2015 Final Table 3. the requirements under the 2015 final rule, which is rounded to 25 percent for purposes of developing Rule Regulatory Evaluation.’’ Pages 12 to 13. the future projections of affected passenger carriers 20 ‘‘Lease and Interchange of Vehicles; Motor 15 U.S. DOLBLS. ‘‘Occupational Employment presented in Table 2. This is a 75 percent reduction Carriers of Passengers. NPRM.’’ September 20, 2013. Projections. Table 1.2: Employment by detailed in the number of passenger carriers affected by the Comments of Greyhound Lines, Inc.. Docket ID occupation, 2016 and projected 2026.’’ Available at: lease and interchange requirements of passenger- number FMCSA–2012–0103–0010. Page 2. https://www.bls.gov/emp/ep_data_occupational_ carrying CMVs as a consequence of the proposed November 12, 2013. Available at: https:// data.htm (accessed December 29, 2017). rule. Continued

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The Agency estimates that 2015 final rule. The remaining 25 FMCSA requests comments and approximately 75 percent of these percent of these trips would experience submission of quantitative or qualitative passenger-carrying CMV trips would partial regulatory relief and remain data addressing the potential number of experience full regulatory relief and subject to reduced lease and interchange passenger-carrying CMV trips that would no longer be subject to the lease requirements compared to those of the would experience regulatory relief and interchange requirements of the 2015 final rule. under the proposed rule.

TABLE 4—ESTIMATED NUMBER OF PASSENGER-CARRYING CMV TRIPS EXPERIENCING REGULATORY RELIEF UNDER THE PROPOSED RULE

Passenger- Passenger- carrying CMV trips carrying CMV trips Total CMV trips experiencing full experiencing experiencing Year regulatory relief partial regulatory regulatory relief under the relief under the under the proposed rule proposed rule proposed rule

2019 ...... 387,714 129,238 516,952 2020 ...... 391,003 130,334 521,337 2021 ...... 394,318 131,440 525,758 2022 ...... 397,663 132,554 530,217 2023 ...... 401,036 133,678 534,714 2024 ...... 404,437 134,812 539,249 2025 ...... 407,866 135,956 543,822 2026 ...... 411,325 137,109 548,434 2027 ...... 414,814 138,271 553,085 2028 ...... 418,332 139,444 557,776

Annual average ...... 402,851 134,284 537,134

Other Key Inputs to the Analysis case a passenger carrier, include all which represents 57 percent of wages The opportunity cost of the time forms of compensation and labor related and salaries in that industry segment of 22 employees of passenger carriers spend expenses. For this regulatory evaluation, $24.73 per hour. complying with the lease and the costs of labor to the firm are Finally, for estimating overhead rates, interchange requirements represents calculated to include base wages and the Agency used industry data gathered approximately 95 percent of the total fringe benefits, plus overhead. for the Truck Costing Model developed cost of the 2015 final rule. The cost For the regulatory evaluation of both by the Upper Great Plains savings from the proposed rule are the 2015 final rule and this proposed Transportation Institute, North Dakota likewise heavily influenced by aggregate rule, the median hourly base wage rate State University.23 Research conducted changes in the opportunity cost of for the BLS SOC code 53–1031, ‘‘First- for this model found an average cost of employee time. Line Supervisors of Transportation and $0.107 per mile of CMV operation for The Agency evaluates changes in Material-Moving Machine and Vehicle management and overhead, and $0.39 employee opportunity cost by using Operators,’’ is used as the basis for per mile for labor, indicating an their labor costs. Labor costs comprise calculating the relevant cost of labor. overhead rate of 27 percent (27% = wages, fringe benefits, and overhead. For 2016, BLS reports an hourly base $0.107 ÷ $0.39 (rounded to the nearest Fringe benefits include paid leave, wage rate of $27.54 for this whole percent)). bonuses and overtime pay, health and occupation.21 Combined, the overall relevant cost of other types of insurance, retirement BLS does not publish data on fringe labor, including base wage rate, fringe plans, and legally required benefits benefits for specific occupations, but it benefits, and overhead, for passenger (Social Security, Medicare, does do so for broad industry groups in carriers that would experience unemployment insurance, and workers’ its Employer Costs for Employee regulatory relief under the proposed compensation insurance). Overhead Compensation (ECEC) publication. A rule is $54.91 per hour. includes any expenses to a firm fringe benefit rate of 57 percent (i.e., Costs associated with labor that are not part of equal to 57 percent of the base wage employees’ compensation, and typically rate) is used. This is based on The proposed rule would not result in includes many types of fixed costs of information from the June 2016 BLS any increase in costs. It revises the 2015 managing a body of employees, such as ECEC data, which for the final rule, which serves as the baseline management and human resource staff ‘‘Transportation and warehousing’’ against which the effects of the salaries or payroll services. The segment of private industry reports a proposed rule are evaluated. Absent the economic costs of labor to a firm, in this benefits cost of $14.09 per hour worked, proposed rule, the Agency estimates

www.regulations.gov/contentStreamer?document reflect employment growth projection for SOC Code workers, by industry group, March 2015.’’ Available Id=FMCSA-2012-0103-0010&attachmentNumber=1 53–3021 (Bus drivers, transit and intercity). at: https://www.bls.gov/news.release/archives/ecec_ &contentType=pdf (accessed March 12, 2018). 21 U.S. DOLBLS. ‘‘Occupational Employment 09082016.pdf (accessed March 5, 2017). Greyhound reported 10,263 passenger-carrying Statistics (OES). National.’’ May 2016. March 31, 23 Berwick, Farooq. Truck Costing Model for CMV trips performed in 2012 by vehicles leased 2017. Available at: https://www.bls.gov/oes/ Transportation Managers. North Dakota State and interchanged. This 2012 value was then special.requests/oesm16nat.zip (accessed January adjusted to reflect observed industry growth from 18, 2018). University. Upper Great Plains Transportation 2012 to 2016 as represented by growth in 22 U.S. DOLBLS . ‘‘Table 10: Employer costs per Institute. August 2003. Appendix A, pp. 42–47. employment for SOC Code 53–3021 (Bus drivers, hour worked for employee compensation and costs Available at: http://www.mountain-plains.org/pubs/ transit and intercity), and then further adjusted to as a percent of total compensation: Private industry pdf/MPC03-152.pdf (accessed July 20, 2015).

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that the baseline costs of the 2015 final trip.25 This savings is valued at the total Lease copying cost savings under the rule over the 10-year analysis period of labor cost of $54.91 per hour, described proposed rule are calculated based on 2019 to 2028 would be $10.4 million on earlier. The resulting savings in one- the number of CMV trips that would an annualized basis at a 7 percent time costs of lease negotiation under the experience regulatory relief under the discount rate.24 As noted earlier, the proposed rule would be $21.3 million proposed rule for this cost category, and Agency estimates that the proposed rule on an undiscounted basis over the 10- an estimated cost per copy. The number would result in a cost savings of $8.2 year analysis period, and $2.8 million of trips that would experience million at a 7 percent discount rate on an annualized basis at a 7 percent regulatory relief under the proposed relative to the 2015 baseline, discount rate. As noted earlier, FMCSA rule for this cost category are the same representing a 79 percent overall proposes to remove the requirement in as above, an annual average of 402,851 reduction in cost. § 390.303(b)(5) that the lease contain a such trips. As in the 2015 regulatory The estimated reduction of statement that the lessee is responsible evaluation, it assumed that for each trip approximately 75 percent in the number for compliance with the insurance one copy of the lease is made for the of passenger carriers and CMV trips requirements of 49 CFR part 387. lessor and another for the lessee, each under the proposed rule is responsible Although in theory this proposed at a cost of $0.15, for a total cost of $0.30 27 for most of the annualized cost savings. change may result in a modest per trip. The resulting in lease copying The remaining cost savings are the incremental reduction in the amount of cost savings under the proposed rule result of reduced requirements for those time passenger carrier employees would be $1.2 million on an approximately 25 percent of passenger expend in negotiating the lease and undiscounted basis over the 10-year carriers and CMV trips that would developing the lease document for analysis period, and $0.12 million on an remain subject to the lease and carriers still subject to the leasing and annualized basis at a 7 percent discount interchange rules. interchange requirements, there is no rate. empirical basis upon which to estimate The remaining three cost categories Under both the 2015 rule and the such a possible impact. Therefore the (lease receipts, vehicle marking, and proposed rule, costs are organized into Agency has chosen not to make any charter party notification) would be six major categories. Five are related to such incremental reduction in its eliminated for all passenger carriers and the requirements under § 390.303 of the analysis. Also, not quantifying such a passenger-carrying trips, including 2015 rule, and include: One-time costs potential impact is a conservative those that would still be subject to lease of lease negotiation; lease approach that helps to avoid and interchange requirements under the documentation costs; lease copying overestimating the cost savings of the proposed rule. costs; lease receipt costs; and vehicle proposed rule. Lease receipt cost savings under the marking costs. The sixth cost category is Lease documentation costs under the 2015 rule are calculated based on the related to the charter party notification number of CMV trips that would proposed rule are calculated based on requirement under § 390.305 of the 2015 experience regulatory relief under the the number of CMV trips that would rule. proposed rule for this cost category, experience regulatory relief under the with two receipts assumed per trip (one One-time costs of lease negotiation proposed rule for this cost category, the for obtaining, the other for surrendering under the proposed rule are calculated time spent by carrier employees the vehicle), and both the lessor and based on the number of CMV trips that verifying the information and signing lessee requiring copies of each, for a would experience regulatory relief the lease, and the total labor cost of total of four receipts per trip. Because under the proposed rule for this cost these employees. The number of trips the proposed rule would remove the category, the time expended by that would experience regulatory relief employees in negotiating the lease and receipt provision in its entirety, the cost under the proposed rule for this cost savings would apply to all trips listed in developing the lease document, and the category are the same as above, an total labor cost of these employees. The Table 4, an annual average of 537,134 annual average of 402,851 trips that trips. Consistent with the 2015 number of trips that would experience would no longer be subject to the lease regulatory relief under the proposed regulatory evaluation, each receipt is and interchange requirements. assumed to cost $0.15, with four rule for this cost category are the trips Consistent with the 2015 regulatory that would no longer be subject to the receipts required for a total of $0.60 per evaluation, for each trip that would 28 lease and interchange requirements. As trip. The resulting cost savings in experience regulatory relief under the lease receipt under the proposed rule presented earlier in Table 4, the Agency proposed rule for this cost category this estimates that an annual average of would be $3.2 million on an analysis assumes that both the lessor undiscounted basis over the 10-year 402,851 passenger-carrying CMV trips and the lessee save 5 minutes of would no longer be subject to the lease analysis period, and $0.321 million on employee time, for a total savings of 10 an annualized basis at a 7 percent and interchange requirements. minutes for each such trip.26 This is Consistent with the approach used in discount rate. valued at the total labor cost of $54.91 Vehicle marking cost savings under the 2015 regulatory evaluation, for each per hour. The resulting savings in lease the 2015 rule are calculated based on of these trips it is assumed that 30 documentation costs under the the number of CMV trips that would minutes of employee time is saved, for proposed rule would be $36.9 million experience regulatory relief under the both the lessor and the lessee, for a total on an undiscounted basis over the 10- proposed rule for this cost category, and time savings of one hour for each such year analysis period, and $3.7 million marking costs per vehicle that include on an annualized basis at a 7 percent two sheets of letter size paper per trip 24 This annualized cost estimate of $10.4 million discount rate. at $0.014 per sheet, plus $0.04 for differs somewhat from the value of $8.0 million that was presented in the regulatory evaluation for the 2015 final rule primarily due to various real and 25 DOT FMCSA, ‘‘Lease and Interchange of 27 DOT FMCSA, ‘‘Lease and Interchange of nominal updates made to reflect more recently Vehicles, Motor Carriers of Passengers, 2015 Final Vehicles, Motor Carriers of Passengers, 2015 Final available data and information, as well as the Rule Regulatory Evaluation.’’ Pages 16 to 17. Rule Regulatory Evaluation.’’ Page 17. different time frames covered by the 10-year 26 DOT FMCSA, ‘‘Lease and Interchange of 28 DOT FMCSA, ‘‘Lease and Interchange of analysis period for each respective analysis Vehicles, Motor Carriers of Passengers, 2015 Final Vehicles, Motor Carriers of Passengers, 2015 Final (previously 2017 to 2026, and now 2019 to 2028). Rule Regulatory Evaluation.’’ Page 17. Rule Regulatory Evaluation.’’ Page 17 to 18.

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adhesive tape. Because the proposed an estimated expenditure by passenger analysis period, and $1.2 million on an rule would remove the marking carrier employees of 5 minutes per annualized basis at a 7 percent discount provision in its entirety, the cost savings notification.29 Because the proposed rate. would apply to all trips listed in Table rule would remove the notification In summary, and as presented in 4, an annual average of 537,134 trips. provision in its entirety, the resulting Table 5, the Agency estimates that the The resulting cost savings in vehicle cost savings would apply to all trips in proposed rule would result in a cost marking under the proposed rule would which notification would otherwise be $0.355 million on an undiscounted savings of $75.1 million on an have been necessary, which are undiscounted basis, $66.5 million basis over the 10-year analysis period, assumed to be 50 percent of the total and $0.035 million on an annualized discounted at 3 percent, and $57.5 annual average of 537,134 passenger- million discounted at 7 percent over the basis at a 7 percent discount rate. 30 Charter party notification cost savings carrying CMV trips listed in Table 4. 10-year analysis period. Expressed on under the 2015 rule are calculated based The resulting savings in charter party an annualized basis, this equates to a on the number of CMV trips that would notification costs under the proposed 10-year cost savings of $7.8 million at a experience regulatory relief under the rule would be $12.1 million on an 3 percent discount rate and $8.2 million proposed rule for this cost category, and undiscounted basis over the 10-year at a 7 percent discount rate.

TABLE 5—TOTAL COST OF THE PROPOSED RULE [In thousands of 2016$]

Undiscounted Discounted Lease and interchange costs Lease Year Charter party Discounted Discounted documentation, Vehicle (a) Lease notification Total cost at 3% at 7% negotiation copying, and marking costs costs (b) lease receipt costs costs

2019 ...... ($21,290) ($3,974) ($34) ($1,168) ($26,467) ($25,697) ($24,736) 2020 ...... 0 (4,008) (34) (1,178) (5,221) (4,921) (4,560) 2021 ...... 0 (4,042) (35) (1,188) (5,265) (4,819) (4,298) 2022 ...... 0 (4,076) (35) (1,198) (5,310) (4,718) (4,051) 2023 ...... 0 (4,111) (35) (1,208) (5,355) (4,619) (3,818) 2024 ...... 0 (4,146) (36) (1,219) (5,401) (4,523) (3,599) 2025 ...... 0 (4,181) (36) (1,229) (5,446) (4,428) (3,392) 2026 ...... 0 (4,216) (36) (1,239) (5,493) (4,336) (3,197) 2027 ...... 0 (4,252) (37) (1,250) (5,539) (4,245) (3,013) 2028 ...... 0 (4,289) (37) (1,261) (5,586) (4,157) (2,840)

Total ...... (21,290) (41,301) (355) (12,139) (75,084) (66,463) (57,504) Annualized ...... (7,508) (7,792) (8,187) Notes: (a) Total cost values may not equal the sum of the components due to rounding. (The totals shown in this column are the rounded sum of unrounded components.) (b) Values shown in parentheses are negative values (i.e., less than zero) and represent a decrease in cost or a cost savings.

Benefits analysis.32 Also referred to as a break- safety, both the 2015 final rule and this even analysis, a threshold analysis proposed rule affect safety less directly The regulatory evaluation for the 2015 attempts to determine the amount of and immediately. Lease and interchange final rule attempted to estimate the safety benefits (e.g., reduced crashes and requirements for motor carriers of potential safety benefits of lease and corresponding reductions in fatalities, passengers improve the ability of the interchange requirements,31 but there injuries, and property damage) that Agency to attribute the inspection, were insufficient data and empirical would need to occur as a consequence compliance, enforcement, and safety evidence to demonstrate a measurable of a rule in order for the rule to yield data collected by the Agency and its quantitative relationship between lease zero net benefits (i.e., for the benefits of State partners to the correct motor and interchange requirements and the rule to equal, or exactly to offset, the carrier and driver, allowing FMCSA to improved safety outcomes, such as estimated costs of the rule). more accurately identify unsafe carriers reduced frequency and/or severity of The problem of insufficient data and and initiate appropriate interventions. crashes or reduced frequency of empirical evidence noted in 2015 is still FMCSA believes that this proposed rule violations. Therefore, FMCSA followed present today. Unlike regulations would be a less costly and burdensome the guidance of the Office of dealing with vehicle equipment or regulatory approach than the 2015 final Management and Budget (OMB) in its driver behaviors that can be clearly rule, yet would still enable safety Circular A–4 and performed a threshold linked to reduced crashes and improved officials and the general public to

29 DOT FMCSA, ‘‘Lease and Interchange of 31 DOT FMCSA, ‘‘Lease and Interchange of www.whitehouse.gov/sites/whitehouse.gov/files/ Vehicles, Motor Carriers of Passengers, 2015 Final Vehicles, Motor Carriers of Passengers, 2015 Final omb/circulars/A4/a-4.pdf (accessed March 9, 2018). Rule Regulatory Evaluation.’’ Page 24 to 26. Rule Regulatory Evaluation.’’ 30 DOT FMCSA, ‘‘Lease and Interchange of 32 OMB. ‘‘Circular A–4. Regulatory Analysis.’’ Vehicles, Motor Carriers of Passengers, 2015 Final September 17, 2003. Available at: https:// Rule Regulatory Evaluation.’’ Page 24 to 26.

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sufficiently identify the passenger on small entities, and mandates that As presented earlier in Table 3 of the carrier responsible for safety. Therefore, agencies strive to lessen any adverse Regulatory Analyses section, as of 2017 the Agency does not anticipate any effects on these entities. Section 605 of there were an estimated 7,774 passenger change to safety benefits as a result of the RFA allows an Agency to certify a carriers subject to the existing lease and the proposed rule. rule, in lieu of preparing an analysis, if interchange requirements, representing FMCSA requests comments and the rulemaking is not expected to have approximately 58 percent of all active submission of quantitative or qualitative a significant economic impact on a interstate passenger carriers. As data addressing the potential impacts to substantial number of small entities. presented in Table 2, this population of safety benefits from the proposed rule. The proposed rule would not result in passenger carriers is projected to B. E.O. 13771 (Reducing Regulation and any increase in costs or any increase in increase slightly due to general baseline Controlling Regulatory Costs) burden. The proposed rule would industry growth to 7,906 passenger reduce the applicability of the lease and This rulemaking is expected to be an carriers in 2019, the first year that the interchange requirements for motor E.O. 13771 deregulatory action.33 proposed rule is anticipated to be in carriers of passengers, resulting in a Details on the estimated cost savings of effect. Therefore, it is estimated that substantial reduction in the number of this rulemaking can be found in the 7,906 passenger carriers would entities that would be subject to these rule’s economic analysis. The present experience regulatory relief under the requirements and a commensurate value of the cost savings of this proposed rule. The number of these reduction in costs and burden rulemaking, measured on an infinite 7,906 passenger carriers that are small experienced by these entities. time horizon at a 7 percent discount entities is not directly known by rate, is $83.6 million. Expressed on an Furthermore, for those motor carriers of FMCSA, and is therefore estimated annualized basis, the cost savings are passengers that would continue to be below. subject to the lease and interchange $5.9 million. These values are expressed The U.S. Small Business in 2016 dollars. requirements under the proposed rule, the requirements would be reduced in Administration (SBA) defines the size C. Regulatory Flexibility Act comparison to the existing standards used to classify entities as small. SBA establishes separate The Regulatory Flexibility Act of 1980 requirements. This would also result in standards for each industry, as defined (RFA) (5 U.S.C. 601 et seq.), as amended a reduction in costs and burden experienced by these entities. by the North American Industry by the Small Business Regulatory 35 Enforcement Fairness Act of 1996 The regulated entities that would Classification System (NAICS). It is (SBREFA) (Pub. L. 104–121, 110 Stat. experience regulatory relief under the estimated that the passenger carriers 857), requires Federal agencies to proposed rule include all of the that would experience regulatory relief consider the impact of their regulatory passenger carriers that are subject to the under the proposed rule would be in proposals on small entities, analyze existing lease and interchange industries within Subsector 485 (Transit effective alternatives that minimize requirements. Approximately 75 percent and Ground Passenger Transportation). small entity impacts, and make their of this total number of passenger All eleven 6-digit NAICS industries analyses available for public comment. carriers would experience full within Subsector 485 have an SBA size The term ‘‘small entities’’ means small regulatory relief, and would no longer standard based on annual revenue of businesses and not-for-profit be subject to lease and interchange $15.0 million. Three of the eleven 6- organizations that are independently requirements for passenger-carrying digit NAICS industries within Subsector owned and operated and are not CMVs. The remaining 25 percent of 485 are likely to encompass most of the dominant in their fields, and these passenger carriers would passenger carriers that would governmental jurisdictions with experience partial regulatory relief and experience regulatory relief under the populations under 50,000.34 remain subject to reduced lease and proposed rule, and details regarding the Accordingly, DOT policy requires an interchange requirements compared to SBA size standards for those three analysis of the impact of all regulations those of the 2015 final rule. industries are presented in Table 6.

TABLE 6—SBA SIZE STANDARDS FOR SELECTED INDUSTRIES (a)

SBA size standard SBA size (annual standard NAICS code NAICS industry description revenue in (number of millions employees) of dollars)

485113 ...... Bus and Other Motor Vehicle Transit Systems ...... $15.0 (none). 485210 ...... Interurban and Rural Bus Transportation ...... 15.0 (none). 485510 ...... Charter Bus Industry ...... 15.0 (none). Notes: (a) U.S. Small Business Administration (SBA). ‘‘Table of Small Business Size Standards.’’ October 1, 2017. Available at: https://www.sba.gov/ sites/default/files/files/Size_Standards_Table_2017.xlsx (accessed March 20, 2018).

Data regarding the annual revenue carriers that would experience rule is not collected by FMCSA and is earned by the estimated 7,906 passenger regulatory relief under the proposed not otherwise available from other

33 Executive Office of the President. Executive 34 Regulatory Flexibility Act, Public Law 96–354, 35 OMB. ‘‘North American Industry Classification Order 13771 of January 30, 2017. Reducing 94 Stat. 1164 (codified at 5 U.S.C. 601 et seq.). System.’’ 2017. Available at: https:// Regulation and Controlling Regulatory Costs. 82 FR www.census.gov/eos/www/naics/2017NAICS/2017_ 9339–9341. Feb. 3, 2017. NAICS_Manual.pdf (accessed March 20, 2018).

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sources. Therefore, the SBA size that the proposed rule would significant economic impact on a standard of $15.0 million in annual disproportionately apply to either larger substantial number of small entities. revenue cannot be directly applied in or smaller passenger carriers, and we FMCSA requests comments on this order to determine how many of the therefore estimate that a similar 98 certification and on the analysis 7,906 passenger carriers that would percent of the 7,906 passenger carriers presented in support of it. experience regulatory relief under the that would experience regulatory relief D. Assistance for Small Entities proposed rule are small entities. FMCSA under the proposed rule, or does, however, collect information approximately 7,750 passenger carriers, In accordance with section 213(a) of regarding the number of passenger- would be small entities. Therefore, the Small Business Regulatory carrying vehicles operated by these FMCSA has determined that this Enforcement Fairness Act of 1996, carriers. As of the end of 2017, of the proposed rule will have an impact on a FMCSA wants to assist small entities in active interstate passenger carriers substantial number of small entities. understanding this proposed rule so that operating in the U.S. as presented Although FMCSA has determined that they can better evaluate its effects and earlier in Table 3, approximately 81 this proposed rule would have an participate in the rulemaking initiative. percent operated six or fewer passenger impact on a substantial number of small If the proposed rule would affect your vehicles, and approximately 93 percent entities, the Agency has determined that small business, organization, or operated 19 or fewer passenger the impact on the small entities that governmental jurisdiction, and you have vehicles.36 We estimate that in the would experience regulatory relief questions concerning its provisions or passenger carrier industry, the average under the proposed rule would not be options for compliance, please consult revenue earned per motorcoach is significant. The proposed rule would the FMCSA point of contact, Ms. Loretta approximately $200,000.37 38 39 This not result in any increase in costs or any Bitner, listed in the FOR FURTHER would mean that the SBA size standard increase in burden for passenger carriers INFORMATION CONTACT section of this of $15.0 million in annual revenue that are small entities. The effect of the proposed rule. would equate to a carrier size of 75 proposed rule would be a reduction in Small businesses may send comments passenger vehicles. Therefore, carriers costs and burden, and would be entirely on the actions of Federal employees operating 75 passenger vehicles or fewer beneficial to the passenger carriers that who enforce or otherwise determine would be classified as small, consistent are small entities. As discussed in the compliance with Federal regulations to with the SBA size standard of $15.0 Regulatory Analyses section, the Agency the Small Business Administration’s million. As of the end of 2017, of the estimates that the proposed rule would Small Business and Agriculture active interstate passenger carriers result in a total cost savings of $75.1 Regulatory Enforcement Ombudsman operating in the U.S. as presented million on an undiscounted basis over and the Regional Small Business earlier in Table 3, approximately 98 the 10-year analysis period used for the Regulatory Fairness Boards. The percent operated 75 or fewer passenger regulatory evaluation, or $7.5 million on Ombudsman evaluates these actions vehicles. The Agency does not believe an annualized basis. As presented in annually and rates each agency’s Table 2, an annual average of responsiveness to small business. If you 36 U.S. DOT, FMCSA. Motor Carrier Management approximately 8,215 passenger carriers wish to comment on actions by Information System (MCMIS), and Licensing and would experience regulatory relief employees of FMCSA, call 1–888–REG– Insurance (L&I) system. Snapshots as of December FAIR (1–888–734–3247). The DOT has a 29, 2017 (DART request ID #38883). under the proposed rule over the same 37 The information available regarding revenue 10-year analysis period, 98 percent of policy regarding the rights of small for the passenger carrier industry is limited. The which are estimated to be small entities. entities to regulatory enforcement American Bus Associated reported that for 2004, The annual cost savings per small fairness and an explicit policy against revenue per motorcoach was approximately carrier would therefore be at most $914 retaliation for exercising these rights.40 $160,000. Inflated from 2004 dollars to 2016 dollars using either CPI–U or the Implicit Price Deflator for on average (potentially even somewhat E. Unfunded Mandates Reform Act of GDP, this value becomes approximately $200,000 less, given that approximately 2 percent 1995 per vehicle. of passenger carriers that would 38 American Bus Association (ABA). ‘‘Motorcoach experience regulatory relief under the The Unfunded Mandates Reform Act Census 2005.’’ September 2006. Page 19, Table of 1995 (2 U.S.C. 1531–1538) requires 3–5 (Carrier Revenue per Motorcoach, Averages, proposed rule are not small entities and 2004). Available at: https://www.iru.org/apps/cms- therefore may represent a Federal agencies to assess the effects of filesystem-action?file=events_2007_busandcoach/ disproportionately larger share of the their discretionary regulatory actions. In Motorcoach%20Census%202005%2009-21- overall absolute cost savings because of particular, the Act requires agencies to 20061.pdf (accessed March 8, 2018). prepare a comprehensive written 39 Greyhound, one of the largest interstate the larger scale of their operations). For passenger carriers operating in the U.S., reported even the smallest of the small entities, statement for any proposed or final rule total revenue for 2017 of $894 million, with 78 those operating only one passenger that may result in the expenditure by percent of that total, or $697 million, being vehicle, this $914 in annual savings State, local, and tribal governments, in passenger revenue. With a fleet size reported to the aggregate, or by the private sector, of consist of 1,600 buses for the same year, this equals represents only about one half of one an average passenger revenue per motorcoach of percent of the estimated total annual $156 million (which is the value $435,000. We believe that substantially higher revenues of $200,000 for a carrier with equivalent of $100 million in 1995, levels of per vehicle revenue such as this are not just one vehicle. Therefore, although adjusted for inflation to 2015 levels) or representative of the smaller passenger carriers that more in any one year. Because this make up most of the industry, and therefore the FMCSA has determined that this lesser estimate of $200,000 revenue per motorcoach proposed rule would have an impact on proposed rule would not result in such described above was used here so as not to risk a substantial number of small entities, an expenditure, a written statement is underestimating the number of small entities in the the Agency has also determined that the not required. However, the Agency does passenger carrier industry when used to compare discuss the costs and benefits of this against the SBA size standard of $15.0 million in impact on these small entities would annual revenue. Greyhound data is from not be significant, and furthermore will ‘‘FirstGroup plc, Annual Report and Accounts, be entirely beneficial. 40 U.S. Department of Transportation (DOT). ‘‘The 2017’’, pages 18–19, available at http://www.first Accordingly, pursuant to section Rights of Small Entities To Enforcement Fairness ∼ groupplc.com/ /media/Files/F/Firstgroup-Plc/ 605(b) of the Regulatory Flexibility Act, and Policy Against Retaliation.’’ Available at: indexed-pdfs/2017%20ARA/2017%20FirstGroup https://www.transportation.gov/sites/dot.gov/files/ %20plc%20Annual%20Report%20and%20 5 U.S.C. 605(b), I hereby certify that the docs/SBREFAnotice2.pdf (accessed January 17, Accounts.pdf (accessed March 19, 2018). proposed rule would not have a 2018).

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proposed rule elsewhere in this approved information collection, the Description of the respondents: preamble. temporary marking of leased Freight-carrying commercial motor commercial passenger vehicles was carriers, passenger-carrying commercial F. Paperwork Reduction Act assumed to have de minimis time motor carriers, and intermodal This proposed rule would amend two burden, and therefore no separate time equipment providers. OMB-approved information collections burden was estimated for that element Number of respondents: titled ‘‘Commercial Motor Vehicle of the passenger-carrying commercial IC–1 (freight carriers) number of Marking Requirements,’’ OMB No. motor carrier marking requirements. respondents: 204,390 2126–0054, and ‘‘Lease and Interchange Because of this, in the proposed revision IC–2 (passenger carriers) number of of Vehicles,’’ OMB No. 2126–0056, to this information collection, there is respondents: 5,007 under the Paperwork Reduction Act of no change in time burden due to IC–3 (intermodal equipment providers) 1995 (44 U.S.C. 3501–3520). As defined program change, and the estimated number of respondents: 11 in 5 CFR 1320.3(c), ‘‘collection of changes in time burden from the Total number of respondents: 209,408 information’’ includes reporting, currently approved information Frequency of response: recordkeeping, monitoring, posting, collection are due to adjustments related IC–1 (freight carriers) frequency of labeling, and other, similar actions. The to factors such as revised estimates of response: 7.9 responses per year, per title and description of the information the population of passenger-carrying respondent collections, a description of those who motor carriers and industry growth rate. IC–2 (passenger carriers) frequency of must collect the information, and an There is a small reduction in the annual response: 20.4 responses per year, per estimate of the total annual burden cost burden, however, related to the respondent follow. The estimate covers the time for elimination of the cost of materials IC–3 (intermodal equipment providers) reviewing instructions, searching (paper and adhesive tape) estimated to frequency of response: 1,910 existing sources of data, gathering and be used for the temporary vehicle responses per year, per respondent maintaining the data needed, and markings that are proposed to be Overall average frequency of response: completing and reviewing the eliminated. 8.3 response per year, per respondent collection. Title: Commercial Motor Vehicle Burden of response: The Agency’s CMV marking Marking Requirements. IC–1 (freight carriers) burden of regulations require freight-carrying response: 0.43 hours commercial motor carriers, passenger- OMB control number: 2126–0054. IC–2 (passenger carriers) burden of carrying commercial motor carriers, and Summary of the collection of response: 0.43 hours intermodal equipment providers to information: Under the information collection, freight-carrying commercial IC–3 (intermodal equipment providers) display the USDOT number and the burden of response: 0.43 hours legal name or a single trade name of the motor carriers, passenger-carrying commercial motor carriers, and Overall average burden of response: 0.43 carrier or intermodal equipment hours provider on their vehicles. The USDOT intermodal equipment providers mark Estimate of Total Annual Burden: number is used to identify all motor their vehicles to display the USDOT carriers in FMCSA’s registration and number and the legal name or a single IC–1 (freight carriers) burden: 699,902 information systems. It is also used by trade name of the carrier or intermodal hours States as the key identifier in the equipment provider. This vehicle IC–2 (passenger carriers) burden: 44,300 Performance and Registration marking occurs when a new vehicle is hours Information Systems Management purchased, when a used vehicle is IC–3 (intermodal equipment providers) (PRISM) system, a cooperative Federal/ purchased and requires re-marking, and burden: 9,108 hours State program that makes motor carrier when a vehicle is retained by the owner Total annual burden: 753,310 hours safety a requirement for obtaining and but the existing label reaches the end of The Agency’s lease and interchange of maintaining CMV registration and its useful life. vehicles regulations ensure that truck privileges. Vehicle marking Need for information: Vehicle and bus carriers are identified (and in requirements are intended to ensure that marking requirements are needed to some cases protected) when they agree FMCSA, the National Transportation ensure that FMCSA, the NTSB, and to lease their equipment and drivers to Safety Board (NTSB), and State safety State safety officials are able to identify other carriers. These regulations also officials are able to identify motor motor carriers and correctly assign ensure that the government and carriers and correctly assign responsibility for regulatory violations members of the public can determine responsibility for regulatory violations during inspections, investigations, who is responsible for a CMV. Prior to during inspections, investigations, compliance reviews, and crash studies. these regulations, some equipment was compliance reviews, and crash studies. These marking requirements also leased without written agreements, These marking requirements also provide the public with beneficial leading to disputes and confusion over provide the public with beneficial information that could assist in which party to the lease was responsible information that could assist in identifying carriers for the purposes of for charges and actions and, at times, identifying carriers for the purposes of commerce, complaints, or emergency who was legally responsible for the commerce, complaints, or emergency notification. vehicle. These recordkeeping notification. Proposed use of information: The requirements enable the general public The proposed rule would eliminate USDOT number is used to identify all and investigators to identify the the existing requirement under 49 CFR motor carriers in FMCSA’s registration passenger carrier responsible for safety, 390.303(f) for the temporary marking of and information systems, is used as the and ensure that FMCSA, our State leased commercial passenger vehicles. key identifier in the PRISM system, and partners, and the NTSB are better able The proposed rule would therefore is used by the public with beneficial to identify the responsible motor carrier amend the OMB-approved information information that could also assist in and therefore correctly assign regulatory collection titled ‘‘Commercial Motor identifying carriers for the purposes of violations to the appropriate carrier Vehicle Marking Requirements,’’ OMB commerce, complaints, or emergency during inspections, investigations, No. 2126–0054. In the currently notification. compliance reviews, and crash studies.

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The proposed rule would reduce the held by the lessor (e.g., those granting the States, or on the distribution of scope of the lease and interchange use of equipment) and lessee (e.g., party power and responsibilities among the requirements for motor carriers of acquiring equipment). They are used to various levels of government.’’ FMCSA passengers. Furthermore, those assign duties and responsibilities. The determined that this proposal would not passenger carriers and passenger- information may also be used by law have substantial direct costs on or for carrying CMV trips for which the enforcement to determine legal States, nor would it limit the proposed rule would remain applicable responsibility in the event that a leased policymaking discretion of States. would be subject to lease and vehicle is in violation of the regulations Nothing in this document preempts any interchange requirements that are or is involved in a crash. State law or regulation. Therefore, this reduced from the current requirements. Description of the respondents: rule does not have sufficient Federalism The applicability of the existing lease Freight-carrying commercial motor implications to warrant the preparation and interchange requirements for motor carriers, and passenger-carrying of a Federalism Impact Statement. carriers of passengers under 49 CFR commercial motor carriers. 390.301 would be revised, resulting in Number of respondents: H. E.O. 12988 (Civil Justice Reform) a substantial reduction of approximately IC–1 (property-carrying CMVs) number This proposed rule meets applicable 75% in the number of passenger carriers of respondents: 35,902 standards in sections 3(a) and 3(b)(2) of and passenger-carrying CMV trips that IC–2 (passenger-carrying CMVs) number E.O. 12988, Civil Justice Reform, to would be subject to the lease and of respondents: 3,987 minimize litigation, eliminate interchange requirement for motor Total number of respondents: 39,889 ambiguity, and reduce burden. carriers of passengers. For those motor Frequency of response: I. E.O. 13045 (Protection of Children) carriers of passengers that would remain subject to the lease and interchange IC–1 (property-carrying CMVs) Executive Order 13045, Protection of requirements under the proposed rule, frequency of response: 19.9 responses Children from Environmental Health the existing requirements under 49 CFR per year, per respondent Risks and Safety Risks (62 FR 19885, 390.303(e) for lease receipt copies IC–2 (passenger-carrying CMVs) April 23, 1997), requires agencies would be eliminated, and the existing frequency of response: 152.4 issuing ‘‘economically significant’’ requirements under 49 CFR 390.305 for responses per year, per respondent rules, if the regulation also concerns an charter party notification would also be Overall average frequency of response: environmental health or safety risk that eliminated. 33.2 response per year, per an agency has reason to believe may The proposed rule would therefore respondent disproportionately affect children, to amend the OMB-approved information Burden of response: include an evaluation of the regulation’s collection titled ‘‘Lease and Interchange IC–1 (property-carrying CMVs) burden environmental health and safety effects of Vehicles,’’ OMB No. 2126–0056. In of response: 0.11 hours on children. The Agency determined the proposed revision to this IC–2 (passenger-carrying CMVs) burden this proposed rule is not economically information collection, there is of response: 0.11 hours significant. Therefore, no analysis of the substantial reduction in time burden Overall average burden of response: 0.11 impacts on children is required. In any due to program change from the hours event, the Agency does not anticipate currently approved information Estimate of total annual burden: that this regulatory action could in any collection as a result of the proposed respect present an environmental or rule. IC–1 (property-carrying CMVs) burden: safety risk that could disproportionately Title: Lease and Interchange of 77,554 hours affect children. Vehicles IC–2 (passenger-carrying CMVs) burden: OMB control number: 2126–0056. 64,802 hours J. E.O. 12630 (Taking of Private Summary of the collection of Total annual burden: 142,356 hours Property) information: Under the information As required by the Paperwork FMCSA reviewed this proposed rule collection, freight-carrying commercial Reduction Act of 1995 (44 U.S.C. in accordance with E.O. 12630, motor carriers and passenger-carrying 3507(d)), FMCSA will submit a copy of Governmental Actions and Interference commercial motor carriers negotiate this proposed rule to OMB for its review with Constitutionally Protected Property leases, prepare and sign lease of the collection of information. Rights, and has determined it would not documents, and produce copies of lease FMCSA asks for public comment on effect a taking of private property or documents. the proposed collection of information otherwise have taking implications. Need for information: The Agency’s to help us determine how useful the lease and interchange of vehicles information is; whether it can help the K. Privacy regulations ensure that truck and bus Agency perform our functions better; Section 522 of title I of division H of carriers are identified (and in some whether it is readily available the Consolidated Appropriations Act, cases protected) when they agree to elsewhere; how accurate our estimate of 2005, enacted December 8, 2004 (Pub. L. lease their equipment and drivers to the burden of collection is; how valid 108–447, 118 Stat. 2809, 3268, 5 U.S.C. other carriers. These regulations also our methods for determining burden 552a note), requires the Agency to ensure that the government and are; how FMCSA can improve the conduct a Privacy Impact Assessment members of the public can determine quality, usefulness, and clarity of the (PIA) of a regulation that will affect the who is responsible for a CMV. These information; and how FMCSA can privacy of individuals. This proposed recordkeeping requirements enable the minimize the burden of collection. rule does not require the collection of general public and investigators to any personally identifiable information. G. E.O. 13132 (Federalism) identify the passenger carrier The Privacy Act (5 U.S.C. 552a) responsible for safety. A rule has implications for applies only to Federal agencies and any Proposed use of information: The Federalism under Section 1(a) of E.O. non-Federal agency that receives government generally collects little 13132 if it has ‘‘substantial direct effects records contained in a system of records information with this ICR. The leases on the States, on the relationship from a Federal agency for use in a and other agreements are developed and between the national government and matching program. FMCSA has

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determined that this rule would not O. E.O. 13175 (Indian Tribal regulations.gov website listed under result in a new or revised Privacy Act Governments) ADDRESSES. System of Records for FMCSA. FMCSA also analyzed this rule under This rule does not have tribal section 176(c) of the Clean Air Act, as The E–Government Act of 2002, implications under E.O. 13175, amended (CAA) (42 U.S.C. 7401 et seq.), Public Law 107–347, sec. 208, 116 Stat. Consultation and Coordination with and implementing regulations 2899, 2921 (December 17, 2002), Indian Tribal Governments, because it promulgated by the Environmental requires Federal agencies to conduct a does not have a substantial direct effect Protection Agency. Approval of this PIA for new or substantially changed on one or more Indian tribes, on the action is exempt from the CAA’s general technology that collects, maintains, or relationship between the Federal conformity requirement since it does disseminates information in an government and Indian tribes, or on the not affect direct or indirect emissions of identifiable form. No new or distribution of power and criteria pollutants. substantially changed technology would responsibilities between the Federal collect, maintain, or disseminate Government and Indian tribes. List of Subjects in 49 CFR Part 390 Highway safety, Intermodal information as a result of this rule. P. National Technology Transfer and transportation, Motor carriers, Motor Accordingly, FMCSA has not conducted Advancement Act (Technical vehicle safety, Reporting and a privacy impact assessment. Standards) recordkeeping requirements. L. E.O. 12372 (Intergovernmental The National Technology Transfer In consideration of the foregoing, Review) and Advancement Act (NTTAA) (15 FMCSA proposes to amend 49 CFR The regulations implementing E.O. U.S.C. 272 note) directs agencies to use chapter III, subchapter B, part 390 to 12372 regarding intergovernmental voluntary consensus standards in their read as follows: regulatory activities unless the agency consultation on Federal programs and PART 390—FEDERAL MOTOR activities do not apply to this program. provides Congress, through OMB, with an explanation of why using these CARRIER SAFETY REGULATIONS; M. E.O. 13211 (Energy Supply, standards would be inconsistent with GENERAL Distribution, or Use) applicable law or otherwise impractical. ■ 1. The authority citation for part 390 Voluntary consensus standards (e.g., continues to read as follows: FMCSA has analyzed this proposed specifications of materials, performance, rule under E.O. 13211, Actions design, or operation; test methods; Authority: 49 U.S.C. 504, 508, 31132, Concerning Regulations That sampling procedures; and related 31133, 31134, 31136, 31137, 31144, 31149, Significantly Affect Energy Supply, management systems practices) are 31151, 31502; sec. 114, Pub. L. 103–311, 108 Distribution, or Use. The Agency has Stat. 1673, 1677; sec. 212 and 217, Pub. L. standards developed or adopted by 106–159, 113 Stat. 1748, 1766, 1767; sec. 229, determined that it is not a ‘‘significant voluntary consensus standards bodies. Pub. L. 106–159 (as added and transferred by energy action’’ under that order because This rule does not use technical sec. 4115 and amended by secs. 4130–4132, it is not a ‘‘significant regulatory action’’ standards. Therefore, FMCSA did not Pub. L. 109–59, 119 Stat. 1144, 1726, 1743; likely to have a significant adverse effect consider the use of voluntary consensus sec. 4136, Pub. L. 109–59, 119 Stat. 1144, on the supply, distribution, or use of standards. 1745; secs. 32101(d) and 32934, Pub. L. 112– 141, 126 Stat. 405, 778, 830; sec. 2, Pub. L. energy. Therefore, it does not require a Q. Environment (NEPA and CAA) Statement of Energy Effects under E.O. 113–125, 128 Stat. 1388; secs. 5403, 5518, and 5524, Pub. L. 114–94, 129 Stat. 1312, 13211. FMCSA analyzed this NPRM for the 1548, 1558, 1560; sec. 2, Pub. L. 115–105, purpose of the National Environmental 131 Stat. 2263; and 49 CFR 1.81, 1.81a, 1.87. N. E.O. 13783 (Promoting Energy Policy Act of 1969 (42 U.S.C. 4321 et Independence and Economic Growth) ■ 2. Amend § 390.5 as follows: seq.) and determined this action is ■ a. Lift the suspension of the section; Executive Order 13783 directs categorically excluded from further ■ b. Revise the definition of ‘‘Lease,’’ executive departments and agencies to analysis and documentation in an ‘‘Lessee,’’ and ‘‘Lessor’’ in alphabetical review existing regulations that environmental assessment or order’’; potentially burden the development or environmental impact statement under ■ c. Suspend § 390.5 indefinitely. FMCSA Order 5610.1 (69 FR 9680, use of domestically produced energy The revised text reads as follows: March 1, 2004), Appendix 2, paragraphs resources, and to appropriately suspend, (6)(y)(2) and (6)(y)(7). The Categorical § 390.5 Definitions. revise, or rescind those that unduly Exclusion (CE) in paragraph (6)(y)(2) * * * * * burden the development of domestic covers regulations implementing motor Lease, as used in subpart G of this 41 energy resources. In accordance with carrier identification and registration part, means a contract or agreement in E.O. 13783, the DOT prepared and reports. The Categorical Exclusion (CE) which a motor carrier of passengers submitted a report to the Director of in paragraph (6)(y)(7) covers regulations grants the use of a passenger-carrying OMB providing specific implementing prohibitions on motor commercial motor vehicle to another recommendations that, to the extent carriers, agents, officers, representatives, motor carrier, with or without a driver, permitted by law, could alleviate or and employees from making fraudulent for a specified period for the eliminate aspects of agency action that or intentionally false statements on any transportation of passengers, whether or burden domestic energy production. application, certificate, report, or record not compensation for such use is The DOT has not identified this required by FMCSA. The proposed specified or required, when one of the proposed rule as potentially alleviating requirements in this rule are covered by motor carriers of passengers is not unnecessary burdens on domestic these CEs, and the proposed action does authorized to operate in interstate energy production under E.O. 13783. not have the potential to significantly commerce pursuant to 49 U.S.C. 13901– affect the quality of the environment. 13902. The term lease includes an 41 Exec. Order No. 13783, 82 FR 16093 (March 31, The CE determination is available for interchange, as defined in this section, 2017). inspection or copying in the or other agreement granting the use of

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a passenger-carrying commercial motor the context of property-carrying displayed in accordance with vehicle for a specified period, with or vehicles, see § 376.2 of this subchapter. paragraphs (c) and (d) of this section; without a driver, whether or not Lessee, as used in subpart G of this and compensation for such use is specified part, means the motor carrier obtaining (iii) The rental agreement or lease as or required. For a definition of lease in the use of a passenger-carrying applicable entered into by the lessor and the context of property-carrying commercial motor vehicle through a the renting motor carrier or lessee vehicles, see § 376.2 of this subchapter. lease as defined in this section, with or conspicuously contains the following Lessee, as used in subpart G of this without the driver, from another motor information: part, means the motor carrier obtaining carrier. The term lessee includes a (A) The name and complete physical the use of a passenger-carrying motor carrier obtaining the use of a address of the principal place of commercial motor vehicle through a passenger-carrying commercial motor business of the renting motor carrier or lease as defined in this section, with or vehicle from another motor carrier lessee; without the driver, from another motor under an interchange or other (B) The identification number issued carrier. The term lessee includes a agreement, with or without a driver, to the renting motor carrier or lessee by motor carrier obtaining the use of a whether or not compensation for such FMCSA, preceded by the letters passenger-carrying commercial motor use is specified. For a definition of ‘‘USDOT,’’ if the motor carrier has been vehicle from another motor carrier lessee in the context of property- issued such a number. In lieu of the under an interchange or other carrying vehicles, see § 376.2 of this identification number required in this agreement, with or without a driver, subchapter. paragraph, the following information whether or not compensation for such Lessor, as used in subpart G of this may be shown in a rental agreement: use is specified. For a definition of part, means the motor carrier granting (1) Whether the motor carrier is lessee in the context of property- the use of a passenger-carrying engaged in ‘‘interstate’’ or ‘‘intrastate’’ carrying vehicles, see § 376.2 of this commercial motor vehicle through a commerce; and subchapter. lease as defined in this section, with or (2) Whether the renting motor carrier Lessor, as used in subpart G of this without a driver, to another motor is transporting hazardous materials in part, means the motor carrier granting carrier. The term lessor includes a motor the rented CMV; the use of a passenger-carrying carrier granting the use of a passenger- (C) The sentence: ‘‘This lessor commercial motor vehicle through a carrying commercial motor vehicle to cooperates with all Federal, State, and lease as defined in this section, with or another motor carrier under an local law enforcement officials without a driver, to another motor interchange or other agreement, with or nationwide to provide the identity of carrier. The term lessor includes a motor without a driver, whether or not customers who operate this rental carrier granting the use of a passenger- compensation for such use is specified. CMV’’; and carrying commercial motor vehicle to For a definition of lessor in the context (iv) The rental agreement or lease as another motor carrier under an of property-carrying vehicles, see applicable entered into by the lessor and interchange or other agreement, with or § 376.2 of this subchapter. the renting motor carrier or lessee is without a driver, whether or not * * * * * carried on the rental CMV or leased compensation for such use is specified. ■ passenger-carrying CMV during the full For a definition of lessor in the context 4. Amend § 390.21 as follows: ■ a. Lift the suspension of the section; term of the rental agreement or lease. of property-carrying vehicles, see ■ b. Revise paragraph (e); See the property-carrying leasing § 376.2 of this subchapter. ■ c. Remove paragraph (f); regulations at 49 CFR part 376 and the * * * * * ■ d. Redesignate paragraphs (g) and (h) passenger-carrying leasing regulations at ■ 3. Amend § 390.5T by revising the as paragraphs (f) and (g), respectively; subpart G of this part for information definitions of ‘‘Lease,’’ ‘‘Lessee,’’ and ■ e. Suspend § 390.21 indefinitely. that should be included in all leasing ‘‘Lessor’’ in alphabetical order to read as The revised text reads as follows: documents. follows: (v) Exception. The passenger-carrying § 390.21 Marking of self-propelled CMVs CMV operating under the 48-hour § 390.5T Definitions. and intermodal equipment. emergency exception pursuant to * * * * * * * * * * § 390.403(a)(2) of this part does not need Lease, as used in subpart G of this (e) Rented CMVs and leased to comply with paragraphs (iii) and (iv) part, means a contract or agreement in passenger-carrying CMVs. A motor of this section, provided the lessor and which a motor carrier of passengers carrier operating a self-propelled CMV lessee comply with the requirements of grants the use of a passenger-carrying under a rental agreement or a passenger- § 390.403(a)(2). commercial motor vehicle to another carrying CMV under a lease, when the * * * * * motor carrier, with or without a driver, rental agreement or lease has a term not ■ for a specified period for the 5. Amend § 390.21T by in excess of 30 calendar days, meets the ■ a. Revising paragraph (e); transportation of passengers, whether or requirements of this section if: ■ b. Removing paragraph (f); not compensation for such use is (1) The CMV is marked in accordance ■ c. Redesignating paragraphs (g) and specified or required, when one of the with the provisions of paragraphs (b) (h) as paragraphs (f) and (g), motor carriers of passengers is not through (d) of this section; or respectively. authorized to operate in interstate (2) Except as provided in paragraph The revision to read as follows: commerce pursuant to 49 U.S.C. 13901– (e)(2)(v), the CMV is marked as set forth 13902. The term lease includes an in paragraph (e)(2)(i) through (iv) of this § 390.21T Marking of self-propelled CMVs interchange, as defined in this section, section: and intermodal equipment. or other agreement granting the use of (i) The legal name or a single trade * * * * * a passenger-carrying commercial motor name of the lessor is displayed in (e) Rented CMVs and leased vehicle for a specified period, with or accordance with paragraphs (c) and (d) passenger-carrying CMVs. A motor without a driver, whether or not of this section. carrier operating a self-propelled CMV compensation for such use is specified (ii) The lessor’s identification number under a rental agreement or a passenger- or required. For a definition of lease in preceded by the letters ‘‘USDOT’’ is carrying CMV under a lease, when the

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rental agreement or lease has a term not Subpart F—[Removed and Reserved] § 390.403 Lease and interchange in excess of 30 calendar days, meets the requirements. requirements of this section if: ■ 6. Remove and reserve subpart F of Except as provided in § 390.401(b) of (1) The CMV is marked in accordance part 390., consisting of §§ 390.301 this section, a motor carrier may with the provisions of paragraphs (b) through 390.305, to read as follows: transport passengers in a leased or through (d) of this section; or ■ 7. Add subpart G, consisting of interchanged commercial motor vehicle (2) Except as provided in paragraph §§ 390.401 and 390.403, to read as only under the following conditions: (e)(2)(v), the CMV is marked as set forth follows: (a) In general—(1) Lease or agreement in paragraph (e)(2)(i) through (iv) of this required. There shall be in effect either: section: (i) A lease granting the use of the (i) The legal name or a single trade Subpart G—Lease and Interchange of passenger-carrying commercial motor name of the lessor is displayed in Passenger-Carrying Commercial Motor vehicle and meeting the conditions of accordance with paragraphs (c) and (d) Vehicles paragraphs (b) and (c) of this section. of this section. Sec. The provisions of the lease shall be (ii) The lessor’s identification number 390.401 Applicability. adhered to and performed by the lessee; preceded by the letters ‘‘USDOT’’ is 390.403 Lease and interchange or displayed in accordance with requirements. (ii) An agreement meeting the paragraphs (c) and (d) of this section; conditions of paragraphs (b) and (c) of and Subpart G—Lease and Interchange of this section and governing the (iii) The rental agreement or lease as Passenger-Carrying Commercial Motor interchange of passenger-carrying applicable entered into by the lessor and Vehicles commercial motor vehicles between motor carriers of passengers conducting the renting motor carrier or lessee § 390.401 Applicability. conspicuously contains the following service on a route or series of routes. information: (a) General. Except as provided in The provisions of the interchange (A) The name and complete physical paragraphs (b)(1) and (2) of this section, agreement shall be adhered to and address of the principal place of this subpart applies to the following performed by the lessee. business of the renting motor carrier or actions, irrespective of duration, or the (2) Exception. When an event occurs lessee; presence or absence of compensation, (e.g., a crash, the vehicle is disabled) (B) The identification number issued by motor carriers operating commercial that requires a motor carrier of to the renting motor carrier or lessee by motor vehicles to transport passengers: passengers immediately to obtain a FMCSA, preceded by the letters (1) The lease of passenger-carrying replacement vehicle from another motor ‘‘USDOT,’’ if the motor carrier has been commercial motor vehicles; and carrier of passengers, the two carriers issued such a number. In lieu of the (2) The interchange of passenger- may postpone the writing of the lease or identification number required in this carrying commercial motor vehicles written agreement for the replacement paragraph, the following information between motor carriers. vehicle for up to 48 hours after the time may be shown in a rental agreement: (b) Exceptions—(1) Contracts and the lessee takes exclusive possession (1) Whether the motor carrier is agreements between motor carriers of and control of the replacement vehicle. engaged in ‘‘interstate’’ or ‘‘intrastate’’ passengers with active passenger carrier However, during that 48-hour (or commerce; and operating authority registrations. This shorter) period, the driver of the vehicle (2) Whether the renting motor carrier subpart does not apply to contracts and must carry, and upon demand of an or lessee is transporting hazardous agreements between motor carriers of enforcement official produce, a materials in the rented or leased CMV; document signed and dated by the (C) The sentence: ‘‘This lessor passengers that have active passenger carrier operating authority registrations lessee’s driver or available company cooperates with all Federal, State, and official stating: ‘‘[Carrier A, USDOT local law enforcement officials with the Federal Motor Carrier Safety Administration when one such motor number, telephone number] has leased nationwide to provide the identity of this vehicle to [Carrier B, USDOT customers who operate this rental or carrier acquires transportation service(s) from another such motor carrier(s). number, telephone number] pursuant to leased CMV’’; and 49 CFR 390.403(a)(2).’’ (iv) The rental agreement or lease as (2) Financial leases. This subpart does (b) Contents of the lease. The lease or applicable entered into by the lessor and not apply to a contract (however interchange agreement required by the renting motor carrier or lessee is designated, e.g., lease, closed-end lease, paragraph (a) of this section shall carried on the rental CMV or leased hire purchase, lease purchase, purchase contain: passenger-carrying CMV during the full agreement, installment plan, etc.) (1) Vehicle identification information. term of the rental agreement or lease. between a motor carrier and a financial The name of the vehicle manufacturer, See the property-carrying leasing organization or a manufacturer or dealer the year of manufacture, and at least the regulations at 49 CFR part 376 and the of passenger-carrying commercial motor last 6 digits of the Vehicle Identification passenger-carrying leasing regulations at vehicles allowing the motor carrier to Number (VIN) of each passenger- subpart G of this part for information use the passenger-carrying commercial carrying commercial motor vehicle that should be included in all leasing motor vehicle. transferred between motor carriers documents. (c) Penalties. If the use of a passenger- pursuant to the lease or interchange (v) Exception. The passenger-carrying carrying commercial motor vehicle is agreement. CMV operating under the 48-hour conferred on one motor carrier subject (2) Parties. The legal name, USDOT emergency exception pursuant to to this subpart by another such motor number, and telephone number of the § 390.403(a)(2) of this part does not need carrier without a lease or interchange motor carrier providing passenger to comply with paragraphs (iii) and (iv) agreement, or pursuant to a lease or transportation in a commercial motor of this section, provided the lessor and interchange agreement that fails to meet vehicle (lessee) and the legal name, lessee comply with the requirements of all applicable requirements of subpart USDOT number, and telephone number § 390.403(a)(2). G, both motor carriers shall be subject of the motor carrier providing the * * * * * to a civil penalty. equipment (lessor), and signatures of

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both parties or their authorized passenger-carrying commercial motor commercial motor vehicle during the representatives. vehicle for the duration of the period of the lease or interchange (3) Specific duration. The time and agreement, and assumes complete agreement, and both the lessee and date when, and the location where, the responsibility for operation of the lessor shall retain a copy of the lease or lease or interchange agreement begins vehicle and compliance with all interchange agreement for 1 year after and ends. applicable Federal regulations for the the expiration date. duration of the agreement. (4) Exclusive possession and Issued under the authority delegated in 49 responsibilities. (i) A clear statement (ii) In the event of a sublease between CFR 1.87 on: September 11, 2018. that the motor carrier obtaining the motor carriers, all of the requirements of Raymond P. Martinez, passenger-carrying commercial motor this section shall apply to a sublease. Administrator. vehicle (the lessee) has exclusive (c) Copies of the lease. A copy shall [FR Doc. 2018–20162 Filed 9–19–18; 8:45 am] possession, control, and use of the be on the passenger-carrying BILLING CODE 4910–EX–P

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Part IV

The President

Memorandum of August 23, 2018—Modernizing the Monetary Reimbursement Model for the Delivery of Goods Through the International Postal System and Enhancing the Security and Safety of International Mail Memorandum of August 31, 2018—Delegation of Authorities Under the Reinforcing Education Accountability in Development Act

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Federal Register Presidential Documents Vol. 83, No. 183

Thursday, September 20, 2018

Title 3— Memorandum of August 23, 2018

The President Modernizing the Monetary Reimbursement Model for the De- livery of Goods Through the International Postal System and Enhancing the Security and Safety of International Mail

Memorandum for the Secretary of State[,] the Secretary of the Treasury[,] the Secretary of Homeland Security[,] the Postmaster General[, and] the Chairman of the Postal Regulatory Commission

By the authority vested in me as President by the Constitution and the laws of the United States of America, it is hereby ordered as follows: Section 1. Definitions. (a) ‘‘Good’’ means any tangible and movable object that can be conveyed by the international postal system, excluding (i) written, drawn, printed, or digital information recorded on a tangible medium that is not an object of merchandise and (ii) money. (b) ‘‘Non-postal operator’’ means a private express carrier, freight forwarder, or other provider of services for the collection, transportation, and delivery of international documents and packages, other than a postal operator. (c) ‘‘Postal operator’’ means a governmental or non-governmental entity officially designated by a Universal Postal Union (UPU) member country to operate postal services and to fulfill the related obligations arising out of the Acts of the UPU on its territory. (d) ‘‘Terminal dues’’ means the rates or fees determined through the UPU and paid by the postal operator in the country of origin to the postal operator in the country of destination to compensate for costs incurred in the country of destination for processing, transportation, and delivery of international ‘‘letter post’’ items, which may include documents or goods and generally weigh up to 4.4 pounds. Sec. 2. Policy. (a) The UPU was established in 1874 by 21 countries. The United States played an integral role in the UPU’s creation and, since that time, the United States has actively participated in all phases of the UPU’s work. The United States is a party to the current Constitution of the UPU—which was adopted in 1964—and intends to continue to participate fully in and financially contribute to the UPU, as provided in Article 21 of the UPU Constitution. As a member country of the UPU, the United States recognizes the importance of this long-standing organization and is proud of the United States’ unbroken record of participation in it. The Congress has provided that the Secretary of State (Secretary), in concluding postal treaties, conventions, or other international agreements, shall, to the maximum extent practicable, take measures to encourage govern- ments of other countries to make available to the United States Postal Service (USPS) and private companies a range of nondiscriminatory customs procedures that will fully meet the needs of all types of American shippers (39 U.S.C. 407(e)(3)). The Congress has likewise directed that responsible officials shall apply the customs laws of the United States and all other laws relating to importa- tion or exportation of goods in the same manner to shipments of goods that are competitive products of the USPS and to similar shipments by private companies (39 U.S.C. 407(e)(2)).

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It is the policy of the United States to promote and encourage the develop- ment of an efficient and competitive global system that provides for fair and nondiscriminatory postal rates. (b) It is in the interest of the United States to: (i) promote and encourage communications between peoples by efficient operation of international postal services and other international delivery services for cultural, social, and economic purposes (39 U.S.C. 407(a)(1)); (ii) promote and encourage unrestricted and undistorted competition in the provision of international postal services and other international deliv- ery services, except where provision of such services by private companies may be prohibited by the laws of the United States (39 U.S.C. 407(a)(2)); (iii) promote and encourage a clear distinction between governmental and operational responsibilities with respect to the provision of international postal services and other international delivery services by the Government of the United States and by intergovernmental organizations of which the United States is a member (39 U.S.C. 407(a)(3)); and (iv) participate in multilateral and bilateral agreements with other countries to accomplish these objectives (39 U.S.C. 407(a)(4)). (c) Some current international postal practices in the UPU do not align with United States economic and national security interests: (i) UPU terminal dues, in many cases, are less than comparable domestic postage rates. As a result: (A) the United States, along with other member countries of the UPU, is in many cases not fully reimbursed by the foreign postal operator for the cost of delivering foreign-origin letter post items, which can result in substantial preferences for foreign mailers relative to domestic mailers; (B) the current terminal dues rates undermine the goal of unrestricted and undistorted competition in cross-border delivery services because they disadvantage non-postal operators seeking to offer competing collection and outward transportation services for goods covered by terminal dues in foreign markets; and (C) the current system of terminal dues distorts the flow of small packages around the world by incentivizing the shipping of goods from foreign countries that benefit from artificially low reimbursement rates. (ii) The UPU has not done enough to reorient international mail to achieve a clear distinction between documents and goods. Without such a distinc- tion, it is difficult to achieve essential pricing reforms or to ensure that customs requirements, including provision of electronic customs data for goods, are met. Under the current system, foreign postal operators do not uniformly furnish advance electronic customs data that are needed to enhance targeting and risk management for national security and to facilitate importation and customs clearance. My Administration’s Initiative to Stop Opioids Abuse and Reduce Drug Supply and Demand, launched in March of this year, requires accurate advance electronic customs data for 90 percent of all international mail shipments that contain goods and consignment shipments within 3 years, so that the Department of Homeland Security can better detect and flag high-risk shipments. (d) It shall be the policy of the executive branch to support efforts that further the policies in this memorandum, including supporting a system of unrestricted and undistorted competition between United States and for- eign merchants. Such efforts include: (i) ensuring that rates charged for delivery of foreign-origin mail containing goods do not favor foreign mailers over domestic mailers; (ii) setting rates charged for delivery of foreign- origin mail in a manner that does not favor postal operators over non-postal operators; and (iii) ensuring the collection of advance electronic customs data.

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Sec. 3. Relations with the UPU. (a) The United States must seek reforms to the UPU that promote the policies outlined in this memorandum. Such reforms shall provide for: (i) a system of fair and nondiscriminatory rates for goods that promotes unrestricted and undistorted competition; and (ii) terminal dues rates that: (A) fully reimburse the USPS for costs to the same extent as domestic rates for comparable services; (B) avoid a preference for inbound foreign small packages containing goods that favors foreign mailers over domestic mailers; and (C) avoid a preference for inbound foreign small packages containing goods that favors postal operators over private-sector entities providing transportation services. (b) If negotiations at the UPU’s September 2018 Second Extraordinary Congress in Ethiopia fail to yield reforms that satisfy the criteria set forth in subsection (a) of this section, the United States will consider taking any appropriate actions to ensure that rates for the delivery of inbound foreign packages satisfy those criteria, consistent with applicable law. Sec. 4. Actions by the Secretary. (a) The Secretary shall notify the Director General of the UPU of the policies and intentions of the United States described in this memorandum. (b) The Secretary or his designee shall, consistent with 39 U.S.C. 407(b)(1), seek agreement on future Convention texts that comport with the policies of this memorandum in meetings of the UPU, including at the September 2018 Extraordinary Congress. (c) No later than November 1, 2018, the Secretary shall submit to the President a report summarizing the steps being taken to implement this memorandum. If the Secretary determines that sufficient progress on reforms to promote compatibility of the Acts of the UPU with the policy of this memorandum is not being achieved, the Secretary shall include recommenda- tions for future action, including the possibility of adopting self-declared rates. Sec. 5. General Provisions. (a) Nothing in this memorandum shall be con- strued to impair or otherwise affect: (i) the authority granted by law to an executive department or agency, or the head thereof; or (ii) the functions of the Director of the Office of Management and Budget relating to budgetary, administrative, or legislative proposals. (b) This memorandum shall be implemented consistent with applicable law and subject to the availability of appropriations. (c) This memorandum is not intended to, and does not, create any right or benefit, substantive or procedural, enforceable at law or in equity by any party against the United States, its departments, agencies, or entities, its officers, employees, or agents, or any other person.

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(d) The Secretary is authorized and directed to publish this memorandum in the Federal Register.

THE WHITE HOUSE, Washington, August 23, 2018

[FR Doc. 2018–20667 Filed 9–19–18; 11:15 am] Billing code 4710–10–P

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Memorandum of August 31, 2018

Delegation of Authorities Under the Reinforcing Education Accountability in Development Act

Memorandum for the Secretary of State [and] the Administrator of the United States Agency for International Development

By the authority vested in me as President by the Constitution and the laws of the United States of America, including section 301 of title 3, United States Code, I hereby: (1) delegate to the Secretary of State the functions and authorities vested in the President by sections 4, 6, and 7 of the Reinforcing Education Account- ability in Development (READ) Act, (Div. A, Public Law 115–56); and (2) delegate to the Administrator of the United States Agency for Inter- national Development the functions and authorities vested in the President by section 5(c) of the READ Act. The delegations in this memorandum shall apply to any provisions of any future public laws that are the same or substantially the same as the provi- sions referenced in this memorandum. The Secretary of State or the Adminis- trator of the United States Agency for International Development, as appro- priate, may redelegate the functions delegated by this memorandum to the extent authorized by law. The Secretary of State is authorized and directed to publish this memo- randum in the Federal Register.

THE WHITE HOUSE, Washington, August 31, 2018

[FR Doc. 2018–20668 Filed 9–19–18; 11:15 am] Billing code 4710–10–P

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Part V

The President

Notice of September 19, 2018—Continuation of the National Emergency With Respect to Persons Who Commit, Threaten To Commit, or Support Terrorism

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Federal Register Presidential Documents Vol. 83, No. 183

Thursday, September 20, 2018

Title 3— Notice of September 19, 2018

The President Continuation of the National Emergency With Respect to Per- sons Who Commit, Threaten To Commit, or Support Ter- rorism

On September 23, 2001, by Executive Order 13224, the President declared a national emergency with respect to persons who commit, threaten to commit, or support terrorism, pursuant to the International Emergency Eco- nomic Powers Act (50 U.S.C. 1701–1706) to deal with the unusual and extraordinary threat to the national security, foreign policy, and economy of the United States constituted by grave acts of terrorism and threats of terrorism committed by foreign terrorists, including the terrorist attacks on September 11, 2001, in New York and Pennsylvania and against the Pentagon, and the continuing and immediate threat of further attacks against United States nationals or the United States. The actions of persons who commit, threaten to commit, or support terrorism continue to pose an unusual and extraordinary threat to the national security, foreign policy, and economy of the United States. For this reason, the national emergency declared in Executive Order 13224 of September 23, 2001, and the measures adopted on that date to deal with that emergency, must continue in effect beyond September 23, 2018. Therefore, in accordance with section 202(d) of the National Emergencies Act (50 U.S.C. 1622(d)), I am continuing for 1 year the national emergency with respect to persons who commit, threaten to commit, or support terrorism declared in Executive Order 13224. This notice shall be published in the Federal Register and transmitted to the Congress.

THE WHITE HOUSE, September 19, 2018. [FR Doc. 2018–20703 Filed 9–19–18; 2:00 pm] Billing code 3295–F8–P

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Reader Aids Federal Register Vol. 83, No. 183 Thursday, September 20, 2018

CUSTOMER SERVICE AND INFORMATION CFR PARTS AFFECTED DURING SEPTEMBER

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. 8 CFR Presidential Documents 3 CFR Executive orders and proclamations 741–6000 Proposed Rules: Proclamations: 212...... 45486 The United States Government Manual 741–6000 9704...... 45019 236...... 45486 Other Services 9705...... 45025 9710...... 45019 9 CFR 741–6020 Electronic and on-line services (voice) 9711...... 45025 Privacy Act Compilation 741–6050 Proposed Rules: 9739...... 45019 557 ...... 47524, 47528, 47532 Public Laws Update Service (numbers, dates, etc.) 741–6043 9740...... 45025 9776...... 45019 10 CFR 9777...... 45025 ELECTRONIC RESEARCH Proposed Rules: 9778...... 45313 Ch. I ...... 45359 9779...... 45315 World Wide Web 430...... 46886 9780...... 45317 431 ...... 45052, 45851, 46886 Full text of the daily Federal Register, CFR and other publications 9781...... 46345 is located at: www.fdsys.gov. 9782...... 46625 11 CFR Federal Register information and research tools, including Public 9783...... 47279 9784...... 47281 Proposed Rules: Inspection List, indexes, and Code of Federal Regulations are 113...... 46888 located at: www.ofr.gov. 9785...... 47539 9786...... 47541 12 CFR E-mail 9787...... 47543 9788...... 47545 229...... 46849 FEDREGTOC (Daily Federal Register Table of Contents Electronic 1003...... 45325 Executive Orders: Mailing List) is an open e-mail service that provides subscribers 1022...... 47027 13847...... 45321 with a digital form of the Federal Register Table of Contents. The 1070...... 46075 13848...... 46843 digital form of the Federal Register Table of Contents includes Proposed Rules: Adminstrative Orders: HTML and PDF links to the full text of each document. 25...... 45053 Memorandums: To join or leave, go to https://public.govdelivery.com/accounts/ 30...... 47313 Memorandum of USGPOOFR/subscriber/new, enter your email address, then 44...... 45860 August 23, 2018...... 47791 follow the instructions to join, leave, or manage your 101...... 47101 Memorandum of subscription. 195...... 45053 August 31, 2018...... 47795 248...... 45860 PENS (Public Law Electronic Notification Service) is an e-mail Presidential 351...... 45860 service that notifies subscribers of recently enacted laws. Determination No. Ch. X...... 45574 2018–11 of To subscribe, go to http://listserv.gsa.gov/archives/publaws-l.html 1248...... 46889 and select Join or leave the list (or change settings); then follow September 10, the instructions. 2018 ...... 46347 14 CFR Notices: FEDREGTOC and PENS are mailing lists only. We cannot Notice of August 31, 25 ...... 45034, 45037, 46098, respond to specific inquiries. 2018 ...... 45191 46101, 47548 Reference questions. Send questions and comments about the Notice of September 39 ...... 44815, 45037, 45041, Federal Register system to: [email protected] 10, 2018 ...... 46067 45044, 45333, 45335, 45539, 45545, 45548, 45550, 45811, The Federal Register staff cannot interpret specific documents or Notice of September 19, 2018 ...... 47799 46369, 46372, 46374, 46377, regulations. 46380, 46384, 46853, 46857, CFR Checklist. Effective January 1, 2009, the CFR Checklist no 5 CFR 46859, 46862, 47042, 47044, longer appears in the Federal Register. This information can be 47047, 47054, 47056 found online at http://bookstore.gpo.gov/. Ch. XIV ...... 46349 71 ...... 45337, 45554, 45813, 1653...... 47547 45814, 45815, 45816, 45818, FEDERAL REGISTER PAGES AND DATE, SEPTEMBER 45819, 45820, 46386, 46387, 7 CFR 46389, 46390, 46391, 46639, 318...... 46627 46864 44815–45030...... 4 47027–47282...... 18 319...... 46627 91...... 47059 45031–45192...... 5 47283–47546...... 19 45193–45324...... 6 457...... 45535 93...... 46865, 47065 47547–47800...... 20 929...... 46069 97 ...... 44816, 44819, 45822, 45325–45534...... 7 1709...... 45031 45824 45535–45810...... 10 1739...... 45031 295...... 46867 45811–46066...... 11 1776...... 45031 298...... 46867 46067–46348...... 12 1783...... 45031 Proposed Rules: 46349–46626...... 13 Proposed Rules: 39 ...... 44844, 45359, 45362, 46627–46848...... 14 301...... 47310 45364, 45578, 45580, 46424, 46849–47026...... 17 927...... 46119 46426, 46428, 46664, 46666, 929...... 46661 46670, 46677, 46679, 46895, 3201...... 46780 46898, 46900, 46902, 46905,

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47113, 47116, 47315, 47318, Proposed Rules: 81 ...... 45830, 45836, 47572 14...... 44831 47321 310...... 46542 180 ...... 45838, 45841, 45844, 20...... 44831 71 ...... 45861, 45863, 46434, 46115, 46394, 46401, 46403, 64...... 44831, 47296 33 CFR 46435, 47577, 47578, 47580, 46405, 47074 68...... 44831 47581, 47583, 47585 100 ...... 44828, 45047, 45339, 300 ...... 46117, 46408, 46660, Proposed Rules: 47069 47076, 47295 63...... 47325 15 CFR 117 ...... 45827, 46392, 46659, 721...... 47004 705...... 46026 46879, 47560 Proposed Rules: 48 CFR 744 ...... 44821, 46103, 46391 151...... 47284 51...... 45588 831...... 46413 165 ...... 44828, 44830, 45047, 52...... 45588 833...... 46413 16 CFR 45049, 45342, 45344, 45346, 60...... 45588 844...... 47097 305...... 47067 45567, 45569, 45571, 46392, 62...... 45589 845...... 47097 310...... 46639 47293, 47562 63...... 46262 852...... 46413 801...... 45555 Proposed Rules: 261...... 46126 871...... 46413 802...... 45555 140...... 47324 271...... 45061, 45068 1506...... 46418 803...... 45555 141...... 47324 300...... 46460 1552...... 46418 Proposed Rules: 142...... 47324 Ch. IX...... 44846 18...... 45582 143...... 47324 721...... 47026 Proposed Rules: 144...... 47324 7...... 45072 17 CFR 145...... 47324 41 CFR 232...... 45592 146...... 47324 301...... 46413 242...... 45592 Proposed Rules: 252...... 45592 75...... 45860 147...... 47324 42 CFR 801...... 45374, 45384 255...... 45860 165 ...... 45059, 45584, 45864, 46449, 47324 Proposed Rules 815...... 45374 19 CFR 403...... 47686 816...... 45374 34 CFR 825...... 45384 12...... 47283 416...... 47686 222...... 47070 418...... 47686 836...... 45384 21 CFR 441...... 47686 837...... 45374 36 CFR 842...... 45384 74...... 47069 460...... 47686 2...... 47071 482...... 47686 846...... 45384 110...... 46104 849...... 45374 117...... 46878 Proposed Rules: 483...... 47686 7...... 47587 484...... 47686 852...... 45374, 45384 172...... 47557 853...... 45384 507...... 46878 13...... 45203 485...... 47686 228...... 46451, 46458 486...... 47686 871...... 45374 Proposed Rules: 1236...... 45587 488...... 47686 20...... 46437 491...... 47686 49 CFR 172...... 47118 37 CFR 494...... 47686 310...... 46121 228...... 46884 Proposed Rules: 720...... 46437 391...... 47486 387...... 45203 43 CFR 807...... 46444 639...... 47574 8365...... 45196 812...... 46444 38 CFR Proposed Rules: 814...... 46444 44 CFR 390...... 47764 3...... 47246 395 ...... 45204, 47589, 47591 64...... 45199, 47077 26 CFR 39 CFR 50 CFR 1...... 45826 Proposed Rules: 45 CFR 3035...... 47119 Proposed Rules: 32...... 45758 29 CFR 410...... 45486 300...... 45849 4022...... 46641 40 CFR 679 ...... 45201, 45202, 46118, 4044...... 46641 9...... 47004 46 CFR 47099 4231...... 46642 52 ...... 45193, 45194, 45348, Proposed Rules: Proposed Rules: Proposed Rules: 45351, 45356, 45827, 45830, 530...... 47123 17...... 45073 Ch. I ...... 46681 45836, 46880, 46882, 47073, 545...... 45367 223...... 47592 2200...... 45366 47564, 47566, 47568, 47569, 224...... 47592 47572 47 CFR 635...... 45866, 47598 32 CFR 60...... 46107 1 ...... 44831, 46812, 47079 648...... 47326 300...... 47069 61...... 46107 6...... 44831 660...... 45396, 47416 571...... 47284 63...... 46107 7...... 44831 665...... 46466

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U.S. Government Publishing Courthouse in Amarillo, Texas, listserv.gsa.gov/archives/ Office, Washington, DC 20402 as the ‘‘J. Marvin Jones publaws-l.html LIST OF PUBLIC LAWS (phone, 202–512–1808). The Federal Building and Mary text will also be made Lou Robinson United States Note: This service is strictly This is a continuing list of available on the Internet from Courthouse’’. (Sept. 18, 2018; public bills from the current GPO’s Federal Digital System 132 Stat. 2893) for E-mail notification of new laws. The text of laws is not session of Congress which (FDsys) at http://www.gpo.gov/ Last List September 19, 2018 have become Federal laws. fdsys. Some laws may not yet available through this service. This list is also available be available. PENS cannot respond to online at http:// specific inquiries sent to this H.R. 5385/P.L. 115–241 www.archives.gov/federal- Public Laws Electronic address. register/laws. Dr. Benjy Frances Brooks Notification Service Children’s Hospital GME (PENS) The text of laws is not Support Reauthorization Act of published in the Federal 2018 (Sept. 18, 2018; 132 Register but may be ordered Stat. 2892) PENS is a free electronic mail in ‘‘slip law’’ (individual H.R. 5772/P.L. 115–242 notification service of newly pamphlet) form from the To designate the J. Marvin enacted public laws. To Superintendent of Documents, Jones Federal Building and subscribe, go to http://

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