Federal Register Vol. 83, No.225,

Federal Register Volume 83, Issue 225 (November 21, 2018)

Page Range58721-59268
FR Document

83_FR_225
Current View
Page and SubjectPDF
83 FR 58757 - Sunshine Act Meeting NoticePDF
83 FR 58757 - Sunshine Act MeetingPDF
83 FR 58765 - Board of Visitors, National Defense University; Notice of Federal Advisory Committee MeetingPDF
83 FR 58767 - Proposed Information Collection Request; Comment Request; Information Collection Request for Reporting Requirements for BEACH Act Grants (Renewal)PDF
83 FR 58768 - Request for Public Review and Comment: Draft Human Health Toxicity Assessments for Hexafluoropropylene Oxide Dimer Acid and Its Ammonium Salt (GenX Chemicals) and for Perfluorobutane Sulfonic Acid (PFBS) and Related Compound Potassium Perfluorobutane SulfonatePDF
83 FR 58762 - Community Bank Advisory Council MeetingPDF
83 FR 58763 - Consumer Advisory Board Subcommittee MeetingsPDF
83 FR 58762 - Credit Union Advisory Council MeetingPDF
83 FR 58809 - KET, LLC-Operation Exemption-Lines of Railroad in Benton County, Wash.PDF
83 FR 58758 - Request for Comments and Notice of Roundtable on Energy, Information and Communication Technology, and Infrastructure in the Indo-Pacific RegionPDF
83 FR 58771 - Logfret, Inc., Complainant v. Kirsha, B.V., Leendert Johanness Bergwerff a/k/a Hans Bergwerff, Linda Sieval, Respondents; Notice of Filing of Complaint and AssignmentPDF
83 FR 58763 - Agency Information Collection Activities; Submission to the Office of Management and Budget for Review and Approval; Comment Request; National Service Criminal History Check Recordkeeping RequirementPDF
83 FR 58806 - Paul Didelius-Continuance in Control Exemption-KET, LLCPDF
83 FR 58784 - Notice of Intent To Prepare an Environmental Impact Statement for the Proposed Campo Wind Energy Project, San Diego, CaliforniaPDF
83 FR 58783 - Draft Environmental Impact Statement for the Little River Band Trust Acquisition and Casino Project, Township of Fruitport, Muskegon County, MichiganPDF
83 FR 58760 - Submission for OMB Review; Comment Request; “Patents for Humanity Program”PDF
83 FR 58761 - Submission for OMB Review; Comment Request; “Patent Review and Derivation Proceedings”PDF
83 FR 58761 - Submission for OMB Review; Comment Request; “Matters Related to First Inventor to File”PDF
83 FR 58814 - Joint Biomedical Laboratory Research and Development and Clinical Science Research and Development Services Scientific Merit Review Board; Notice of MeetingsPDF
83 FR 58765 - Agency Information Collection Activities; Comment Request; Performance Partnership Pilots ApplicationPDF
83 FR 58756 - Submission for OMB Review; Comment RequestPDF
83 FR 58755 - Notice of Public Meeting of the Assembly of the Administrative Conference of the United StatesPDF
83 FR 58754 - Fisheries of the Exclusive Economic Zone Off Alaska; Pacific Cod by Catcher/Processors Using Trawl Gear in the Central Regulatory Area of the Gulf of AlaskaPDF
83 FR 58782 - Habitat Conservation Plan for Seven Species in the Santa Clara River Watershed; Categorical Exclusion for Foothill Feeder Inspection and Maintenance Activities, Los Angeles County, CaliforniaPDF
83 FR 58764 - Proposed Collection; Comment RequestPDF
83 FR 58771 - Notice of Agreement FiledPDF
83 FR 58807 - CSX Transportation, Inc.-Lease-Western and Atlantic RailroadPDF
83 FR 58771 - Change in Bank Control Notices; Acquisitions of Shares of a Bank or Bank Holding CompanyPDF
83 FR 58766 - Fusion Energy Sciences Advisory CommitteePDF
83 FR 58757 - Heavy Walled Rectangular Welded Carbon Steel Pipes and Tubes From the Republic of Turkey: Affirmative Final Results of Countervailing Duty Administrative ReviewPDF
83 FR 58813 - Department of Transportation Advisory Committee on Human Trafficking; Notice of Public MeetingPDF
83 FR 58745 - Safety Zone; Ohio River, Mile 28.0 to 29.2, Vanport, PennsylvaniaPDF
83 FR 58721 - Miscellaneous Corrections-Organizational ChangesPDF
83 FR 58788 - New Postal ProductsPDF
83 FR 58787 - Arts Advisory Panel MeetingsPDF
83 FR 58775 - Administration on Intellectual and Developmental Disabilities, President's Committee for People With Intellectual DisabilitiesPDF
83 FR 58777 - Charter Renewal of the Advisory Committee on Blood and Tissue Safety and AvailabilityPDF
83 FR 58766 - Combined Notice of Filings #1PDF
83 FR 58760 - Submission for OMB Review; Comment RequestPDF
83 FR 58787 - Memorandum of Understanding Between the U.S. Nuclear Regulatory Commission and the Wyoming Department of Environmental QualityPDF
83 FR 58770 - FDIC Systemic Resolution Advisory Committee; Notice of MeetingPDF
83 FR 58806 - 60-Day Notice of Proposed Information Collection: Overseas Schools Grant Status ReportPDF
83 FR 58811 - Petition for Exemption; Summary of Petition Received; Delta Air Lines, Inc.PDF
83 FR 58739 - Special Conditions: Garmin International, Textron Aviation Inc. Model 560XL; Airplane Electronic-System Security Protection From Unauthorized Internal AccessPDF
83 FR 58740 - Special Conditions: Garmin International, Textron Aviation Inc. Model 560XL; Airplane Electronic-System Security Protection From Unauthorized External AccessPDF
83 FR 58810 - Agency Information Collection Activities: Requests for Comments; Clearance of Renewed Approval of Information Collection: Certification of AirportsPDF
83 FR 58810 - Agency Information Collection Activities: Requests for Comments; Clearance of Renewed Approval of Information Collection: Pilot Certification and Qualification Requirements for Air Carrier OperationsPDF
83 FR 58812 - Agency Information Collection Activities: Requests for Comments; Clearance of Renewed Approval of Information Collection: Report of Inspections Required by Airworthiness DirectivesPDF
83 FR 58800 - Self-Regulatory Organizations; Cboe Futures Exchange, LLC; Notice of Filing of a Proposed Rule Change Regarding Minor Rule ViolationsPDF
83 FR 58805 - Data Collection Available for Public CommentsPDF
83 FR 58779 - Center for Scientific Review; Notice of Closed MeetingPDF
83 FR 58778 - National Institute of Neurological Disorders and Stroke; Notice of Closed MeetingsPDF
83 FR 58778 - National Heart, Lung, and Blood Institute; Notice of Closed MeetingPDF
83 FR 58779 - National Heart, Lung, and Blood Institute; Notice of MeetingsPDF
83 FR 58776 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; General Licensing Provisions; Requirements on Content and Format of Labeling for Human Prescription Drug and Biological ProductsPDF
83 FR 58778 - National Institute on Aging; Notice of Closed MeetingPDF
83 FR 58724 - Large Financial Institution Rating System; Regulations K and LLPDF
83 FR 58779 - Fiscal Year (FY) 2019 Funding OpportunityPDF
83 FR 58775 - Use of the Names of Dairy Foods in the Labeling of Plant-Based Products; Extension of Comment PeriodPDF
83 FR 58813 - Notice of OFAC Sanctions ActionsPDF
83 FR 58781 - Agency Information Collection Activities; Revision of a Currently Approved Collection; Application for NaturalizationPDF
83 FR 58789 - Self-Regulatory Organizations; Cboe BZX Exchange, Inc.; Notice of Filing of a Proposed Rule Change To List and Trade Shares of the JPMorgan Inflation Managed Bond ETF of the J.P. Morgan Exchange-Traded Fund Trust Under Rule 14.11(i), Managed Fund SharesPDF
83 FR 58794 - Self-Regulatory Organizations; NYSE American LLC; Notice of Filing and Immediate Effectiveness of Proposed Change To Modify the NYSE American Options Fee SchedulePDF
83 FR 58798 - Self-Regulatory Organizations; LCH SA; Notice of Filing and Immediate Effectiveness of Proposed Rule Change, as Modified by Amendment No. 1, Relating to a New Fee Incentive SchemePDF
83 FR 58802 - Self-Regulatory Organizations; Cboe BYX Exchange, Inc.; Order Instituting Proceedings To Determine Whether To Approve or Disapprove a Proposed Rule Change To Make Permanent Exchange Rule 11.24, Which Sets Forth the Exchange's Pilot Retail Price Improvement ProgramPDF
83 FR 58795 - Self-Regulatory Organizations; Cboe EDGA Exchange, Inc.; Notice of Filing and Immediate Effectiveness of a Proposed Rule Change Relating To Amend the Exchange's Fee Schedule Applicable to its Equities Trading PlatformPDF
83 FR 58771 - Agency Information Collection Activities: Announcement of Board Approval Under Delegated Authority and Submission to OMBPDF
83 FR 58773 - Agency Information Collection Activities: Announcement of Board Approval Under Delegated Authority and Submission to OMBPDF
83 FR 58785 - Notice of Intent To Prepare an Integrated Activity Plan and Environmental Impact Statement for the National Petroleum Reserve in AlaskaPDF
83 FR 58804 - Data Collection Available for Public CommentsPDF
83 FR 58786 - Supplemental Information Regarding Arizona Capital Counsel MechanismPDF
83 FR 58745 - Drawbridge Operation Regulation; Okeechobee Waterway (Caloosahatchee River), LaBelle, FLPDF
83 FR 58743 - Amendment of Class E Airspace, Mountain City, TN; and Establishment of Class E Airspace; Elizabethton, TNPDF
83 FR 58742 - Amendment of Class D Airspace and Establishment of Class E Airspace; Tyndall AFB, FLPDF
83 FR 58747 - Endangered and Threatened Wildlife and Plants; Endangered Species Status for the Candy DarterPDF
83 FR 59232 - Endangered and Threatened Wildlife and Plants; Designation of Critical Habitat for the Candy DarterPDF
83 FR 58780 - Collection of Information Under Review by Office of Management and Budget; OMB Control Number: 1625-0035PDF
83 FR 59182 - Passenger Equipment Safety Standards; Standards for Alternative Compliance and High-Speed TrainsetsPDF
83 FR 58818 - Medicare Program: Changes to Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems and Quality Reporting ProgramsPDF

Issue

83 225 Wednesday, November 21, 2018 Contents Administrative Administrative Conference of the United States NOTICES Meetings: Assembly of the Administrative Conference of the United States, 58755-58756 2018-25401 Agriculture Agriculture Department NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 58756-58757 2018-25395 2018-25403 Consumer Financial Protection Bureau of Consumer Financial Protection NOTICES Meetings: Community Bank Advisory Council, 58762-58763 2018-25421 Consumer Advisory Board Subcommittee, 58763 2018-25420 Credit Union Advisory Council, 58762 2018-25419 Centers Medicare Centers for Medicare & Medicaid Services RULES Medicare Program: Changes to Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems and Quality Reporting Programs, 58818-59179 2018-24243 Chemical Chemical Safety and Hazard Investigation Board NOTICES Meetings; Sunshine Act, 58757 2018-25534 Civil Rights Civil Rights Commission NOTICES Meetings; Sunshine Act, 58757 2018-25588 Coast Guard Coast Guard RULES Drawbridge Operations: Okeechobee Waterway (Caloosahatchee River), LaBelle, FL, 58745 2018-25332 Safety Zone: Ohio River, Mile 28.0 to 29.2, Vanport, Pennsylvania, 58745-58747 2018-25379 NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 58780-58781 2018-25268 Commerce Commerce Department See

International Trade Administration

See

National Oceanic and Atmospheric Administration

See

Patent and Trademark Office

Community Living Administration Community Living Administration NOTICES Meetings: Administration on Intellectual and Developmental Disabilities, Presidents Committee for People With Intellectual Disabilities, 58775 2018-25375 Corporation Corporation for National and Community Service NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: National Service Criminal History Check Recordkeeping Requirement, 58763-58764 2018-25414 Defense Department Defense Department NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 58764-58765 2018-25393 Meetings: Board of Visitors, National Defense University, 58765 2018-25432 Education Department Education Department NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Performance Partnership Pilots Application, 58765-58766 2018-25404 Energy Department Energy Department See

Federal Energy Regulatory Commission

NOTICES Meetings: Fusion Energy Sciences Advisory Committee, 58766 2018-25382
Environmental Protection Environmental Protection Agency NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Reporting Requirements for BEACH Act Grants (Renewal), 58767-58768 2018-25423 Draft Human Health Toxicity Assessments for Hexafluoropropylene Oxide Dimer Acid and its Ammonium Salt (GenX Chemicals) and for Perfluorobutane Sulfonic Acid (PFBS) and Related Compound Potassium Perfluorobutane Sulfonate, 58768-58770 2018-25422 Federal Aviation Federal Aviation Administration RULES Amendment of Class D Airspace and Establishment of Class E Airspace: Tyndall AFB, FL, 58742-58743 2018-25328 Amendment of Class E Airspace; and Establishment of Class E Airspace: Mountain City, TN; and Elizabethton, TN, 58743-58744 2018-25329 Special Conditions: Garmin International, Textron Aviation Inc. Model 560XL; Airplane Electronic-System Security Protection From Unauthorized External Access, 58740-58742 2018-25362 Garmin International, Textron Aviation Inc. Model 560XL; Airplane Electronic-System Security Protection From Unauthorized Internal Access, 58739-58740 2018-25363 NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Certification of Airports, 58810-58811 2018-25361 Pilot Certification and Qualification Requirements for Air Carrier Operations, 58810 2018-25360 Report of Inspections Required by Airworthiness Directives, 58812-58813 2018-25359 Petitions for Exemptions; Summaries: Delta Air Lines, Inc., 58811-58812 2018-25364 Federal Deposit Federal Deposit Insurance Corporation NOTICES Meetings: Systemic Resolution Advisory Committee, 58770-58771 2018-25366 Federal Energy Federal Energy Regulatory Commission NOTICES Combined Filings, 58766-58767 2018-25371 Federal Maritime Federal Maritime Commission NOTICES Agreements Filed, 58771 2018-25389 Complaints: Logfret, Inc., v. Kirsha, B. V., Leendert Johanness Bergwerff a/k/a Hans Bergwerff, Linda Sieval, 58771 2018-25415 Federal Railroad Federal Railroad Administration RULES Passenger Equipment Safety Standards; Standards for Alternative Compliance and High-Speed Trainsets, 59182-59230 2018-25020 Federal Reserve Federal Reserve System RULES Large Financial Institution Rating System (Regulations K and LL), 58724-58739 2018-25350 NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 58771-58775 2018-25338 2018-25339 Changes in Bank Control: Acquisitions of Shares of a Bank or Bank Holding Company, 58771 2018-25383 Fish Fish and Wildlife Service RULES Endangered and Threatened Species: Endangered Species Status for the Candy Darter, 58747-58754 2018-25316 PROPOSED RULES Endangered and Threatened Species: Designation of Critical Habitat for the Candy Darter, 59232-59268 2018-25315 NOTICES Habitat Conservation Plan for Seven Species in the Santa Clara River Watershed; Categorical Exclusion for Foothill Feeder Inspection and Maintenance Activities, Los Angeles County, California, 58782-58783 2018-25397 Food and Drug Food and Drug Administration NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: General Licensing Provisions; Requirements on Content and Format of Labeling for Human Prescription Drug and Biological Products, 58776-58777 2018-25352 Use of the Names of Dairy Foods in the Labeling of Plant-Based Products; Extension of Comment Period, 58775-58776 2018-25347 Foreign Assets Foreign Assets Control Office NOTICES Blocking or Unblocking of Persons and Properties, 58813-58814 2018-25346 Health and Human Health and Human Services Department See

Centers for Medicare & Medicaid Services

See

Community Living Administration

See

Food and Drug Administration

See

National Institutes of Health

See

Substance Abuse and Mental Health Services Administration

NOTICES Charter Renewals: Advisory Committee on Blood and Tissue Safety and Availability, 58777-58778 2018-25374
Homeland Homeland Security Department See

Coast Guard

See

U.S. Citizenship and Immigration Services

Indian Affairs Indian Affairs Bureau NOTICES Environmental Impact Statements; Availability, etc.: Little River Band Trust Acquisition and Casino Project, Township of Fruitport, Muskegon County, MI, 58783-58784 2018-25411 Proposed Campo Wind Energy Project, San Diego, CA, 58784-58785 2018-25412 Interior Interior Department See

Fish and Wildlife Service

See

Indian Affairs Bureau

See

Land Management Bureau

International Trade Adm International Trade Administration NOTICES Antidumping or Countervailing Duty Investigations, Orders, or Reviews: Heavy Walled Rectangular Welded Carbon Steel Pipes and Tubes From the Republic of Turkey, 58757-58758 2018-25381 Meetings: Roundtable on Energy, Information and Communication Technology, and Infrastructure in the Indo-Pacific Region, 58758-58760 2018-25417 Justice Department Justice Department NOTICES Supplemental Information Regarding Arizona Capital Counsel Mechanism, 58786-58787 2018-25333 Land Land Management Bureau NOTICES Environmental Impact Statements; Availability, etc.: National Petroleum Reserve in Alaska, 58785-58786 2018-25336 National Endowment for the Arts National Endowment for the Arts NOTICES Meetings: Arts Advisory Panel, 58787 2018-25376 National Foundation National Foundation on the Arts and the Humanities See

National Endowment for the Arts

National Institute National Institutes of Health NOTICES Meetings: Center for Scientific Review, 58779 2018-25356 National Heart, Lung, and Blood Institute, 58778-58779 2018-25353 2018-25354 National Institute of Neurological Disorders and Stroke, 58778-58779 2018-25355 National Institute on Aging, 58778 2018-25351 National Oceanic National Oceanic and Atmospheric Administration RULES Fisheries of the Exclusive Economic Zone Off Alaska: Pacific Cod by Catcher/Processors Using Trawl Gear in the Central Regulatory Area of the Gulf of Alaska, 58754 2018-25399 NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 58760 2018-25368 Nuclear Regulatory Nuclear Regulatory Commission RULES Organizational Changes; Miscellaneous Corrections, 58721-58724 2018-25378 NOTICES Memorandum of Understanding Between the U.S. Nuclear Regulatory Commission and the Wyoming Department of Environmental Quality, 58787-58788 2018-25367 Patent Patent and Trademark Office NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Matters Related to First Inventor To File, 58761-58762 2018-25408 Patent Review and Derivation Proceedings, 58761 2018-25409 Patents for Humanity Program, 58760 2018-25410 Postal Regulatory Postal Regulatory Commission NOTICES New Postal Products, 58788-58789 2018-25377 Securities Securities and Exchange Commission NOTICES Self-Regulatory Organizations; Proposed Rule Changes: Cboe BYX Exchange, Inc., 58802-58804 2018-25341 Cboe BZX Exchange, Inc., 58789-58794 2018-25344 Cboe EDGA Exchange, Inc., 58795-58798 2018-25340 Cboe Futures Exchange, LLC, 58800-58802 2018-25358 LCH SA, 58798-58800 2018-25342 NYSE American, LLC, 58794-58795 2018-25343 Small Business Small Business Administration NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 58804-58805 2018-25335 2018-25348 2018-25357 State Department State Department NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Overseas Schools Grant Status Report, 58806 2018-25365 Substance Substance Abuse and Mental Health Services Administration NOTICES Funding Opportunities: Fiscal Year 2019; Single Source Grant to the Community Anti-Drug Coalitions of America, 58779-58780 2018-25349 Surface Transportation Surface Transportation Board NOTICES Continuances in Control Exemptions: Paul Didelius; KET, LLC, 58806-58807 2018-25413 Leases: CSX Transportation, Inc.; Western and Atlantic Railroad, 58807-58809 2018-25388 Operation Exemptions: KET, LLC; Lines of Railroad in Benton County, WA, 58809-58810 2018-25418 Transportation Department Transportation Department See

Federal Aviation Administration

See

Federal Railroad Administration

NOTICES Meetings: Advisory Committee on Human Trafficking, 58813 2018-25380
Treasury Treasury Department See

Foreign Assets Control Office

U.S. Citizenship U.S. Citizenship and Immigration Services NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Application for Naturalization, 58781-58782 2018-25345 Veteran Affairs Veterans Affairs Department NOTICES Meetings: Joint Biomedical Laboratory Research and Development and Clinical Science Research and Development Services Scientific Merit Review Board, 58814-58815 2018-25405 Separate Parts In This Issue Part II Health and Human Services Department, Centers for Medicare & Medicaid Services, 58818-59179 2018-24243 Part III Transportation Department, Federal Railroad Administration, 59182-59230 2018-25020 Part IV Interior Department, Fish and Wildlife Service, 59232-59268 2018-25315 Reader Aids

Consult the Reader Aids section at the end of this issue for phone numbers, online resources, finding aids, and notice of recently enacted public laws.

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83 225 Wednesday, November 21, 2018 Rules and Regulations NUCLEAR REGULATORY COMMISSION 10 CFR Parts 37, 40, 70, 71, 72, 73, 76, and 95 [NRC-2018-0183] RIN 3150-AK14 Miscellaneous Corrections—Organizational Changes AGENCY:

Nuclear Regulatory Commission.

ACTION:

Final rule.

SUMMARY:

The U.S. Nuclear Regulatory Commission (NRC) is amending its regulations to make miscellaneous corrections. These changes include removing an office from a list of office recipients, removing an office reference, correcting an office designation and a phone number, removing and correcting division titles, and removing a followup reporting instruction. This document is necessary to inform the public of these non-substantive amendments to the NRC's regulations.

DATES:

This final rule is effective on December 21, 2018.

ADDRESSES:

Please refer to Docket ID NRC-2018-0183 when contacting the NRC about the availability of information for this action. You may obtain publicly-available information related to this action by any of the following methods:

Federal Rulemaking Website: Go to http://www.regulations.gov and search for Docket ID NRC-2018-0183. Address questions about NRC dockets to Carol Gallagher; telephone: 301-415-3463; email: [email protected].

NRC's Agencywide Documents Access and Management System (ADAMS): You may obtain publicly-available documents online in the ADAMS Public Documents Collection at http://www.nrc.gov/reading-rm/adams.html. To begin the search, select “Begin Web-based ADAMS Search.” For problems with ADAMS, please contact the NRC's Public Document Room (PDR) reference staff at 1-800-397-4209, 301-415-4737, or by email to [email protected].

NRC's PDR: You may examine and purchase copies of public documents at the NRC's PDR, Room O1-F21, One White Flint North, 11555 Rockville Pike, Rockville, Maryland 20852.

FOR FURTHER INFORMATION CONTACT:

Jill Shepherd-Vladimir, Office of Nuclear Material Safety and Safeguards, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001; telephone: 301-415-1230, email: [email protected].

SUPPLEMENTARY INFORMATION: I. Introduction

The NRC is amending its regulations in parts 37, 40, 70, 71, 72, 73, 76, and 95 of title 10 of the Code of Federal Regulations (10 CFR) to make miscellaneous corrections. These changes include removing an office from a list of office recipients, removing an office reference, correcting an office designation and a phone number, removing and correcting division titles, and removing a followup reporting instruction. This document is necessary to inform the public of these non-substantive amendments to the NRC's regulations.

II. Summary of Changes 10 CFR Part 37

Remove Office Reference. In § 37.7(a), this final rule removes the Director, Division of Security Policy, Office of Nuclear Security and Incident Response, from the list of recipients.

10 CFR Parts 37 and 40

Remove Reporting Instruction. In §§ 37.81(g) and 40.64(c)(2) and (3), this final rule removes the erroneous instructions for where to submit a copy of a followup notification. These paragraphs already point to the sections that provide the appropriate mailing address and addressee(s).

10 CFR Parts 37, 40, 70, 71, 72, and 73

Remove Division Title. In §§ 37.77, 40.23(b)(1), 40.66(a) and (b)(5), 40.67(a), 70.5, 70.20, 71.97, 73.4, 73.37, 73.71, 73.72, 73.73, and 73.74, this final rule removes the Division of Security Policy to ensure that correspondence goes directly to the Director, Office of Nuclear Security and Incident Response rather than to a division director.

10 CFR Parts 40, 73, and 76

Correct Division Title. In §§ 40.23(c), 40.66(c), and 40.67(c) and (d), 73.26, 73.27, 73.67, and 76.5a, this final rule corrects the title of the Division of Security Policy to read as Division of Physical and Cyber Security Policy.

10 CFR Part 40

Correct Designation. In § 40.23(b)(2)(ix), this final rule replaces the Division of Security Policy with the higher level designation of the Office of Nuclear Security and Incident Response.

Correct Telephone Number. In § 40.23(d), this final rule removes the incorrect telephone number “(301) 415-6828” and replaces it with the correct telephone number “(301) 287-3598” for the Director of the Division of Physical and Cyber Security Policy.

10 CFR Part 70

Correct Office Designation. In § 70.32(c)(2), (e), and (i), this final rule replaces the Office of Nuclear Security and Incident Response with the Office of Nuclear Material Safety and Safeguards.

10 CFR Part 72

Remove Division Title. In § 72.186(b), this final rule removes the Division of Spent Fuel Management so that notifications go to the Director, Office of Nuclear Material Safety and Safeguards rather than to division level management.

10 CFR Part 95

Remove Division Title. In § 95.9(a), this final rule removes the Division of Security Operations so that notification go to Office level management rather than division level management.

III. Rulemaking Procedure

Under section 553(b) of the Administrative Procedure Act (5 U.S.C. 553(b)), an agency may waive the requirements for publication in the Federal Register of a notice of proposed rulemaking and opportunity for comment if it finds, for good cause, that it is impracticable, unnecessary, or contrary to the public interest. As authorized by 5 U.S.C. 553(b)(3)(B), the NRC finds good cause to waive notice and opportunity for comment on these amendments, because notice and opportunity for comment is unnecessary. The amendments will have no substantive impact and are of a minor and administrative nature dealing with corrections to certain CFR sections or are related only to management, organization, procedure, and practice. These changes include removing an office from a list of office recipients, removing an office reference, correcting an office designation and a phone number, removing and correcting division titles, and removing a followup reporting instruction. The Commission is exercising its authority under 5 U.S.C. 553(b) to publish these amendments as a final rule. The amendments are effective December 21, 2018. These amendments do not require action by any person or entity regulated by the NRC, and do not change the substantive responsibilities of any person or entity regulated by the NRC.

IV. Environmental Impact: Categorical Exclusion

The NRC has determined that this final rule is the type of action described in 10 CFR 51.22(c)(2), which categorically excludes from environmental review rules that are corrective or of a minor, nonpolicy nature and do not substantially modify existing regulations. Therefore, neither an environmental impact statement nor an environmental assessment has been prepared for this rule.

V. Paperwork Reduction Act

This final rule does not contain a collection of information as defined in the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq.) and, therefore, is not subject to the requirements of the Paperwork Reduction Act of 1995.

Public Protection Notification

The NRC may not conduct or sponsor, and a person is not required to respond to, a collection of information unless the document requesting or requiring the collection displays a currently valid OMB control number.

VI. Plain Writing

The Plain Writing Act of 2010 (Pub. L. 111-274) requires Federal agencies to write documents in a clear, concise, and well-organized manner. The NRC has written this document to be consistent with the Plain Writing Act as well as the Presidential Memorandum, “Plain Language in Government Writing,” published June 10, 1998 (63 FR 31883).

VII. Backfitting and Issue Finality

The NRC has determined that the corrections in this final rule do not constitute backfitting and are not inconsistent with any of the issue finality provisions in 10 CFR part 52. The amendments are non-substantive in nature, including removing an office from a list of office recipients, removing an office reference, correcting an office designation and a phone number, removing and correcting division titles, and removing a followup reporting instruction. They impose no new requirements and make no substantive changes to the regulations. The corrections do not involve any provisions that would impose backfits as defined in 10 CFR chapter I, or would be inconsistent with the issue finality provisions in 10 CFR part 52. For these reasons, the issuance of the rule in final form would not constitute backfitting or represent a violation of any of the issue finality provisions in 10 CFR part 52. Therefore, the NRC has not prepared any additional documentation for this correction rulemaking addressing backfitting or issue finality.

VIII. Congressional Review Act

This final rule is not a rule as defined in the Congressional Review Act (5 U.S.C. 801-808).

List of Subjects 10 CFR Part 37

Byproduct material, Criminal penalties, Exports, Hazardous materials transportation, Imports, Licensed material, Nuclear materials, Penalties, Radioactive materials, Reporting and recordkeeping requirements, Security measures.

10 CFR Part 40

Criminal penalties, Exports, Government contracts, Hazardous materials transportation, Hazardous waste, Nuclear energy, Nuclear materials, Penalties, Reporting and recordkeeping requirements, Source material, Uranium, Whistleblowing.

10 CFR Part 70

Classified information, Criminal penalties, Emergency medical services, Hazardous materials transportation, Material control and accounting, Nuclear energy, Nuclear materials, Packaging and containers, Penalties, Radiation protection, Reporting and recordkeeping requirements, Scientific equipment, Security measures, Special nuclear material, Whistleblowing.

10 CFR Part 71

Criminal penalties, Hazardous materials transportation, Incorporation by reference, Intergovernmental relations, Nuclear materials, Packaging and containers, Penalties, Radioactive materials, Reporting and recordkeeping requirements.

10 CFR Part 72

Administrative practice and procedure, Hazardous waste, Indians, Intergovernmental relations, Nuclear energy, Penalties, Radiation protection, Reporting and recordkeeping requirements, Security measures, Spent fuel, Whistleblowing.

10 CFR Part 73

Criminal penalties, Exports, Hazardous materials transportation, Incorporation by reference, Imports, Nuclear energy, Nuclear materials, Nuclear power plants and reactors, Penalties, Reporting and recordkeeping requirements, Security measures.

10 CFR Part 76

Certification, Criminal penalties, Nuclear energy, Penalties, Radiation protection, Reporting and recordkeeping requirements, Security measures, Special nuclear material, Uranium, Uranium enrichment by gaseous diffusion.

10 CFR Part 95

Classified information, Criminal penalties, Penalties, Reporting and recordkeeping requirements, Security measures.

For the reasons set out in the preamble and under the authority of the Atomic Energy Act of 1954, as amended; the Energy Reorganization Act of 1974, as amended; and 5 U.S.C. 552 and 553, the NRC is adopting the following amendments to 10 CFR parts 37, 40, 70, 71, 72, 73, 76, and 95:

PART 37—PHYSICAL PROTECTION OF CATEGORY 1 AND CATEGORY 2 QUANTITIES OF RADIOACTIVE MATERIAL 1. The authority citation for part 37 continues to read as follows: Authority:

Atomic Energy Act of 1954, secs. 11, 53, 81, 103, 104, 147, 148, 149, 161, 182, 183, 223, 234, 274 (42 U.S.C. 2014, 2073, 2111, 2133, 2134, 2167, 2168, 2169, 2201, 2232, 2233, 2273, 2282, 2021); Energy Reorganization Act of 1974, secs. 201, 202 (42 U.S.C. 5841, 5842); 44 U.S.C. 3504 note.

2. Revise § 37.7(a) to read as follows:
§ 37.7 Communications.

(a) By mail addressed to: ATTN: Document Control Desk; Director, Office of Nuclear Reactor Regulation; Director, Office of New Reactors; or Director, Office of Nuclear Material Safety and Safeguards, as appropriate, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001;

§ 37.77 [Amended]
3. In § 37.77, wherever it appears, remove the title “Division of Security Policy,” and in paragraph (c)(1), remove the phrase “of Nuclear Security”.
§ 37.81 [Amended]
4. In § 37.81(g) introductory text, remove the third sentence. PART 40—DOMESTIC LICENSING OF SOURCE MATERIAL 5. The authority citation for part 40 continues to read as follows: Authority:

Atomic Energy Act of 1954, secs. 62, 63, 64, 65, 69, 81, 83, 84, 122, 161, 181, 182, 183, 184, 186, 187, 193, 223, 234, 274, 275 (42 U.S.C. 2092, 2093, 2094, 2095, 2099, 2111, 2113, 2114, 2152, 2201, 2231, 2232, 2233, 2234, 2236, 2237, 2243, 2273, 2282, 2021, 2022); Energy Reorganization Act of 1974, secs. 201, 202, 206, 211 (42 U.S.C. 5841, 5842, 5846, 5851); Uranium Mill Tailings Radiation Control Act of 1978, sec. 104 (42 U.S.C. 7914); 44 U.S.C. 3504 note.

§ 40.23 [Amended]
6. Amend § 40.23 as follows: a. In paragraph (b)(1), remove the title “Division of Security Policy,”; b. In paragraph (b)(2)(ix), remove the title “Division of Security Policy” and add in its place the title “Office of Nuclear Security and Incident Response”. c. In paragraph (c), remove the title “Division of Security Policy” and add in its place the title “Division of Physical and Cyber Security Policy”. d. In paragraph (d), remove the title “Division of Security Policy” and add in its place the title “Division of Physical and Cyber Security Policy”; and remove the telephone number “(301) 415-6828” and add in its place the telephone number “301-287-3598”.
§ 40.64 [Amended]
7. In § 40.64(c)(2) and (3), remove the last sentence in each paragraph.
§ 40.66 [Amended]
8. Amend § 40.66 as follows: a. In paragraph (a), remove the title “Division of Security Policy,”; b. In paragraph (b)(5), remove the title “Division of Security Policy,” and add in its place the title “Director,”; and c. In paragraph (c), remove the title “Division of Security Policy,” and add in its place the title “Director,”.
§ 40.67 [Amended]
9. Amend § 40.67 as follows: a. In paragraph (a), remove the title “Division of Security Policy,”; and b. In paragraphs (c) and (d), remove the title “Division of Security Policy” and add in its place the phrase “Director, Office of Nuclear Security and Incident Response”. PART 70—DOMESTIC LICENSING OF SPECIAL NUCLEAR MATERIAL 10. The authority citation for part 70 continues to read as follows: Authority:

Atomic Energy Act of 1954, secs. 51, 53, 57(d), 108, 122, 161, 182, 183, 184, 186, 187, 193, 223, 234, 274, 1701 (42 U.S.C. 2071, 2073, 2077(d), 2138, 2152, 2201, 2232, 2233, 2234, 2236, 2237, 2243, 2273, 2282, 2021, 2297f); Energy Reorganization Act of 1974, secs. 201, 202, 206, 211 (42 U.S.C. 5841, 5842, 5846, 5851); Nuclear Waste Policy Act of 1982, secs. 135, 141 (42 U.S.C. 10155, 10161); 44 U.S.C. 3504 note.

§ § 70.5 and 70.20b [Amended]
11. In §§ 70.5 and 70.20b, wherever it appears, remove the title “Division of Security Policy,”.
§ 70.32 [Amended]
12. In § 70.32, wherever it appears, remove the title “Division of Security Policy, Office of Nuclear Security and Incident Response” and add in its place the title “Office of Nuclear Material Safety and Safeguards”. PART 71—PACKAGING AND TRANSPORTATION OF RADIOACTIVE MATERIAL 13. The authority citation for part 71 continues to read as follows: Authority:

Atomic Energy Act of 1954, secs. 53, 57, 62, 63, 81, 161, 182, 183, 223, 234, 1701 (42 U.S.C. 2073, 2077, 2092, 2093, 2111, 2201, 2232, 2233, 2273, 2282, 2297f); Energy Reorganization Act of 1974, secs. 201, 202, 206, 211 (42 U.S.C. 5841, 5842, 5846, 5851); Nuclear Waste Policy Act of 1982, sec. 180 (42 U.S.C. 10175); 44 U.S.C. 3504 note. Section 71.97 also issued under Sec. 301, Public Law 96-295, 94 Stat. 789 (42 U.S.C. 5841 note).

§ 71.97 [Amended]
14. In § 71.97, wherever it appears, remove the title “Division of Security Policy,”. PART 72—LICENSING REQUIREMENTS FOR THE INDEPENDENT STORAGE OF SPENT NUCLEAR FUEL, HIGH-LEVEL RADIOACTIVE WASTE, AND REACTOR-RELATED GREATER THAN CLASS C WASTE 15. The authority citation for part 72 continues to read as follows: Authority:

Atomic Energy Act of 1954, secs. 51, 53, 57, 62, 63, 65, 69, 81, 161, 182, 183, 184, 186, 187, 189, 223, 234, 274 (42 U.S.C. 2071, 2073, 2077, 2092, 2093, 2095, 2099, 2111, 2201, 2210e, 2232, 2233, 2234, 2236, 2237, 2238, 2273, 2282, 2021); Energy Reorganization Act of 1974, secs. 201, 202, 206, 211 (42 U.S.C. 5841, 5842, 5846, 5851); National Environmental Policy Act of 1969 (42 U.S.C. 4332); Nuclear Waste Policy Act of 1982, secs. 117(a), 132, 133, 134, 135, 137, 141, 145(g), 148, 218(a) (42 U.S.C. 10137(a), 10152, 10153, 10154, 10155, 10157, 10161, 10165(g), 10168, 10198(a)); 44 U.S.C. 3504 note.

§ 72.186 [Amended]
16. In § 72.186(b), remove the title “Division of Spent Fuel Management,”. PART 73—PHYSICAL PROTECTION OF PLANTS AND MATERIALS 17. The authority citation for part 73 continues to read as follows: Authority:

Atomic Energy Act of 1954, secs. 53, 147, 149, 161, 170D, 170E, 170H, 170I, 223, 229, 234, 1701 (42 U.S.C. 2073, 2167, 2169, 2201, 2210d, 2210e, 2210h, 2210i, 2273, 2278a, 2282, 2297f); Energy Reorganization Act of 1974, secs. 201, 202 (42 U.S.C. 5841, 5842); Nuclear Waste Policy Act of 1982, secs. 135, 141 (42 U.S.C. 10155, 10161); 44 U.S.C. 3504 note. Section 73.37(b)(2) also issued under Sec. 301, Public Law 96-295, 94 Stat. 789 (42 U.S.C. 5841 note).

§ § 73.4, 73.37, 73.71, 73.72, 73.73 and 73.74 [Amended]
18. In §§ 73.4, 73.37, 73.71, 73.72, 73.73, and 73.74, wherever it appears, remove the title “Division of Security Policy,”.
§ § 73.26, 73.27, and 73.67 [Amended]
19. In §§ 73.26, 73.27, and 73.67, wherever it appears, remove the title “Division of Security Policy” and add in its place the title “Division of Physical and Cyber Security Policy”. PART 76—CERTIFICATION OF GASEOUS DIFFUSION PLANTS 20. The authority citation for part 76 continues to read as follows: Authority:

Atomic Energy Act of 1954, secs. 122, 161, 193(f), 223, 234, 1701 (42 U.S.C. 2152, 2201, 2243(f), 2273, 2282, 2297f); Energy Reorganization Act of 1974, secs. 201, 206, 211 (42 U.S.C. 5841, 5846, 5851); 44 U.S.C. 3504 note.

§ 76.5 [Amended]
21. In § 76.5(a), remove the title “Division of Security Policy,”. PART 95—FACILITY SECURITY CLEARANCE AND SAFEGUARDING OF NATIONAL SECURITY INFORMATION AND RESTRICTED DATA 22. The authority citation for part 95 continues to read as follows: Authority:

Atomic Energy Act of 1954, secs. 145, 161, 223, 234 (42 U.S.C. 2165, 2201, 2273, 2282); Energy Reorganization Act of 1974, sec. 201 (42 U.S.C. 5841); 44 U.S.C. 3504 note; E.O. 10865, as amended, 25 FR 1583, 3 CFR, 1959-1963 Comp., p. 398; E.O. 12829, 58 FR 3479, 3 CFR, 1993 Comp., p. 570; E.O. 12968, 60 FR 40245, 3 CFR, 1995 Comp., p. 391; E.O. 13526, 75 FR 707, 3 CFR, 2009 Comp., p. 298.

§ 95.9 [Amended]
23. In § 95.9(a), remove the title “Division of Security Operations,”. Dated at Rockville, Maryland, this 16th day of November 2018.

For the Nuclear Regulatory Commission.

Pamela J. Shepherd-Vladimir, Acting Chief, Regulatory Analysis and Rulemaking Support Branch, Office of Nuclear Material Safety and Safeguards.
[FR Doc. 2018-25378 Filed 11-20-18; 8:45 am] BILLING CODE 7590-01-P
FEDERAL RESERVE SYSTEM 12 CFR Parts 211 and 238 [Docket No. R-1569] RIN 7100-AE82 Large Financial Institution Rating System; Regulations K and LL AGENCY:

Board of Governors of the Federal Reserve System (Board).

ACTION:

Final rule.

SUMMARY:

The Board is adopting a new rating system for large financial institutions in order to align with the Federal Reserve's current supervisory programs and practices for these firms. The final rating system applies to bank holding companies and non-insurance, non-commercial savings and loan holding companies with total consolidated assets of $100 billion or more, and U.S. intermediate holding companies of foreign banking organizations established under Regulation YY with total consolidated assets of $50 billion or more. The rating system will assign component ratings for capital planning and positions, liquidity risk management and positions, and governance and controls, and introduces a new rating scale. The Federal Reserve will assign initial ratings under the new rating system in 2019 for bank holding companies and U.S. intermediate holding companies subject to the Large Institution Supervision Coordinating Committee framework and in 2020 for all other large financial institutions. The Board is revising provisions in Regulations K and LL so they will remain consistent with certain features of the new rating system.

DATES:

The final rule is effective on February 1, 2019.

FOR FURTHER INFORMATION CONTACT:

Richard Naylor, Associate Director, (202) 728-5854, Molly Mahar, Associate Director, (202) 973-7360, Vaishali Sack, Assistant Director, (202) 452-5221, Christine Graham, Manager, (202) 452-3005, Division of Supervision and Regulation; Laurie Schaffer, Associate General Counsel, (202) 452-2272, Benjamin W. McDonough, Assistant General Counsel, (202) 452-2036, Scott Tkacz, Senior Counsel, (202) 452-2744, Keisha Patrick, Senior Counsel, (202) 452-3559, or Christopher Callanan, Counsel, (202) 452-3594, Legal Division, Board of Governors of the Federal Reserve System, 20th and C Streets NW, Washington, DC 20551. Telecommunications Device for the Deaf (TDD) users may contact (202) 263-4869.

SUPPLEMENTARY INFORMATION: Table of Contents I. Background II. Notice of Proposed Rulemaking and Overview of Comments III. Overview of Final Rule and Modifications From the Proposal IV. Final LFI Rating System A. Applicability B. Timing and Implementation C. LFI Rating Components D. LFI Rating Scale E. General Comments V. Changes to Existing Regulations VI. Comparison of the RFI and LFI Rating Systems VII. Regulatory Analysis A. Paperwork Reduction Act B. Regulatory Flexibility Analysis C. Solicitation of Comments on Use of Plain Language List of Subjects Appendix A—Text of Large Financial Institution Rating System I. Background

The Board is adopting a new supervisory ratings framework for certain large financial institutions that is designed to:

• Align with the Federal Reserve's current supervisory programs and practices;

• Enhance the clarity and consistency of supervisory assessments and communications of supervisory findings and implications; and

• Provide transparency related to the supervisory consequences of a given rating.

The final ratings framework applies to bank holding companies and non-insurance, non-commercial savings and loan holding companies with total consolidated assets of $100 billion or more, and U.S. intermediate holding companies of foreign banking organizations established under Regulation YY with total consolidated assets of $50 billion or more.

In the years following the 2007-2009 financial crisis, the Federal Reserve developed a supervisory program specifically designed to enhance resiliency and address the risks posed by large financial institutions to U.S. financial stability (LFI supervisory program). As set forth in SR letter 12-17/CA letter 12-14, the LFI supervisory program focuses supervisory attention on the core areas that are most likely to threaten the firm's financial and operational strength and resilience (capital, liquidity, and governance and controls).1 This orientation is intended to reduce the likelihood of the failure or material distress of a large financial institution, and reduce the risk to U.S. financial stability in the event of failure.

1 “Financial strength and resilience” is defined as maintaining effective capital and liquidity governance and planning processes, and sufficiency of related positions, to provide for continuity of the consolidated organization (including its critical operations and banking offices) through a range of conditions.

“Operational strength and resilience” is defined as maintaining effective governance and controls to provide for continuity of the consolidated organization (including its critical operations and banking offices) and to promote compliance with laws and regulations, including those related to consumer protection, through a range of conditions.

Under SR letter 12-17/CA letter 12-14, “banking offices” are defined as U.S. depository institution subsidiaries and the U.S. branches and agencies of foreign banking organizations.

The Federal Reserve coordinates its supervision of firms that pose the greatest risk to U.S. financial stability through the Large Institution Supervision Coordinating Committee (LISCC). The LISCC supervisory program conducts annual horizontal reviews of LISCC firms and firm-specific examination work focused on evaluating those firms' (i) capital adequacy under normal and stressed conditions; (ii) liquidity positions and risk management practices; (iii) recovery and resolution preparedness; and (iv) governance and controls.2 For large financial institutions that are not LISCC firms, the Federal Reserve performs horizontal reviews and firm-specific supervisory work focused on capital, liquidity, and governance and control practices, which are tailored to reflect the risk characteristics of these institutions.

2 See the list of firms included in the LISCC supervisory program at https://www.federalreserve.gov/bankinforeg/large-institution-supervision.htm.

Since 2004, the Federal Reserve has used the “RFI/C(D)” rating system (referred to as the “RFI rating system”) to communicate its supervisory assessment of every bank holding company regardless of its asset size, complexity, or systemic importance.3 The RFI rating system is focused on the risk management practices (R component) and financial condition (F component) of the consolidated organization, and includes an assessment of the potential impact (I component) of a bank holding company's nondepository entities on its subsidiary depository institution(s).

3See SR letter 04-18, “Bank Holding Company Rating System,” 69 FR 70444 (December 6, 2004), at https://www.federalreserve.gov/boarddocs/srletters/2004/sr0418.htm.

The Federal Reserve adopted to apply the RFI rating system on a fully implemented basis to all savings and loan holding companies (SLHCs) with total consolidated assets of less than $100 billion, excluding SLHCs engaged in significant insurance or commercial activities. See 83 FR 56081 (November 9, 2018). The Federal Reserve had applied the RFI rating system to SLHCs on an indicative basis since assuming supervisory responsibility for those firms from the Office of Thrift Supervision in 2011.

The Federal Reserve has not modified the RFI rating system to reflect the substantial changes to the statutory and regulatory framework relating to large financial institutions, or the Federal Reserve's implementation of the LFI supervisory program in recent years. In light of these changes, the Board is adopting a new rating system applicable to these firms that is more closely aligned with the LFI supervisory program, so that the ratings more directly communicate the results of the Federal Reserve's supervisory assessment.

Because the statutory, regulatory, and supervisory framework for community and regional bank holding companies has not undergone material changes since the financial crisis, the RFI rating system remains a relevant and effective tool for developing and communicating supervisory assessments for those firms. Therefore, the RFI rating system will continue to be used in the supervision of these organizations.

II. Notice of Proposed Rulemaking and Overview of Comments

On August 17, 2017, the Board invited public comment on a notice of proposed rulemaking to adopt a new rating system for large financial institutions (proposed LFI rating system).4 The proposed LFI rating system would have applied to bank holding companies and non-insurance, non-commercial savings and loan holding companies with total consolidated assets of $50 billion or more, and U.S. intermediate holding companies (U.S. IHCs) of foreign banking organizations established under Regulation YY.5

4 82 FR 39049 (August 17, 2017).

5 12 CFR 252.153.

Under the proposed LFI rating system, each banking organization would have been assigned ratings for three separate components: Capital Planning and Positions; Liquidity Risk Management and Positions; and Governance and Controls. The ratings would have been assigned using a four-point non-numeric scale (Satisfactory/Satisfactory Watch, Deficient-1, and Deficient-2).6 A firm would need a “Satisfactory” or “Satisfactory Watch” rating for each of the three component ratings to be considered “well managed” for various purposes under the Board's rules and federal law. The proposal would not have included the assignment of a standalone composite rating or any subcomponent ratings. In addition, the proposal would have amended certain provisions of the Board's existing regulations (Regulation K and Regulation LL) to make them compatible with the proposed rating scale.

6 In the proposed LFI rating system, Satisfactory Watch was a subcategory of “Satisfactory.”

The Board received 16 comments on the proposal from supervised firms, trade associations, industry consultants, and individuals. In addition, Federal Reserve staff held several meetings on the proposal with members of the public and obtained supplementary information from certain commenters. Summaries of these meetings are available on the Board's public website.

Most commenters generally supported the proposal to develop a new rating system that would be aligned with the Federal Reserve's LFI supervisory program. However, many commenters also expressed concerns regarding specific aspects of the proposal, including the applicability and implementation of the proposed LFI rating system and its underlying components, the lack of a standalone composite rating, the ratings scale, and the consequences of ratings assigned under the rating system.

Separately, the Board invited comment on two other proposals closely related to the proposed LFI rating system. The first proposal addressed proposed guidance on supervisory expectations for boards of directors, which set forth attributes of an effective board of directors of LFIs,7 and the second proposal addressed an LFI's management of business lines and independent risk management and controls.8 The Board continues to consider comments on these proposals, and thus, is not adopting either proposal at this time.

7 82 FR 37219 (August 9, 2017).

8 83 FR 1351 (January 11, 2018).

III. Overview of Final Rule and Modifications From the Proposal

The final rating system adopts the core elements of the proposed LFI rating system, with certain modifications to address commenter concerns. Consistent with the proposal, a banking organization will be assigned three component ratings: Capital Planning and Positions; Liquidity Risk Management and Positions; and Governance and Controls. In addition, although the final LFI rating system retains a four-category, non-numeric rating scale, it identifies the top two categories as “Broadly Meets Expectations” and Conditionally Meets Expectations” to align with the definitions of those categories.

IV. Final LFI Rating System A. Applicability

In the proposal, the LFI rating system would have applied to bank holding companies, non-insurance, non-commercial savings and loan holding companies, and U.S. IHCs of foreign banking organizations with $50 billion or more in total consolidated assets. The Board received several comments regarding the applicability of the LFI rating system. For example, one commenter suggested that the Board should use risk-based factors instead of asset size to determine which firms are subject to the LFI rating system. Another commenter suggested that the $50 billion threshold should be raised.

In addition to the comments received, the Board has taken into consideration that since the proposal, section 401 of the Economic Growth, Regulatory Relief, and Consumer Protection Act (EGRRCPA) amended section 165 of the Dodd-Frank Wall Street Reform and Consumer Protection Act (Dodd-Frank Act) to modify the $50 billion minimum asset threshold for general application of enhanced prudential standards.9 Effective immediately on the date of its enactment, bank holding companies with total consolidated assets equal to or greater than $50 billion and less than $100 billion were no longer subject to these standards.10

9 Public Law 115-174, section 401, 132 Stat. 1296 (2018).

10 Section 401(f) of EGRRCPA also provides that any bank holding company, regardless of asset size, that has been identified as a Global Systemically Important Bank (GSIB) under the Board's GSIB capital surcharge rule shall be considered a bank holding company with $250 billion or more in total consolidated assets for purposes of applying the standards under section 165 and certain other provisions. EGRRCPA section 401.

The Board issued two statements—one individually, and the other jointly with the FDIC and OCC—that provided information on Board-administered regulations and associated reporting requirements that EGRRCPA immediately affected. See Board and Interagency statements regarding the impact of the Economic Growth, Regulatory Relief, and Consumer Protection Act (EGRRCPA), July 6, 2018, available at https://www.federalreserve.gov/newsevents/pressreleases/files/bcreg20180706a1.pdf; https://www.federalreserve.gov/newsevents/pressreleases/files/bcreg20180706b1.pdf. The statements describe interim positions that the Board and other agencies have taken until the agencies finalize amendments to their regulations to implement EGRRCPA.

In consideration of the comments received and the statutory changes under EGRRCPA, the final LFI rating system is being adopted for bank holding companies and, non-insurance and non-commercial savings and loan holding companies with total consolidated assets of $100 billion or more, and for U.S. IHCs of foreign banking organizations established under Regulation YY with total consolidated assets of $50 billion or more.11 The decision to increase the asset threshold to $100 billion for bank holding companies and non-insurance, non-commercial SLHCs is consistent with the minimum threshold for enhanced prudential standards established by EGRRCPA as well as the Board's intention to tailor certain of its regulations for domestic firms to implement EGRRCPA.12 The Board has retained the asset threshold of $50 billion for U.S. IHCs of foreign banking organizations as it continues to consider appropriate tailoring of its regulations for FBOs in light of EGRRCPA; however, the Board may adjust this asset threshold in the future if necessary.

11 For a bank holding company and savings and loan holding company, total consolidated assets of $100 billion or more will be calculated based on the average of the firm's total consolidated assets in the four most recent quarters as reported on the firm's quarterly financial reports filed with the Federal Reserve. A firm will continue to be rated under the final LFI rating system until it has less than $95 billion in total consolidated assets, based on the average total consolidated assets as reported on the firm's four most recent quarterly financial reports filed with the Federal Reserve. As noted in the proposal, the Federal Reserve may determine to apply the RFI rating system or another applicable rating system in certain limited circumstances.

SLHCs are considered to be engaged in significant commercial activities if they derive 50 percent or more of their total consolidated assets or total revenues from activities that are not financial in nature under section 4(k) of the Bank Holding Company Act of 1956, as amended (12 U.S.C. 1843(k)). SLHCs are considered to be engaged in significant insurance underwriting activities if they are either insurance companies or hold 25 percent or more of their total consolidated assets in subsidiaries that are insurance companies. SLHCs that meet these criteria are excluded from the definition of “covered savings and loan holding company” in § 217.2 of the Board's Regulation Q. See 12 CFR 217.2.

12See 83 FR 56081 (November 9, 2018).

Bank holding companies with total consolidated assets of at least $50 billion but less than $100 billion will continue to be evaluated subject to the RFI rating system. The Board is currently reviewing existing supervisory guidance with respect to these firms to determine whether it is appropriate to make revisions to further distinguish supervisory expectations for firms with total consolidated assets of less than $100 billion.

The proposed LFI rating system would not have applied to SLHCs that are predominantly engaged in insurance or commercial activities. The Board continues to consider the appropriate regulatory regime for these firms. As such, the Board will continue to rate these SLHCs on an indicative basis under the RFI rating system as it considers further the appropriate manner to assign supervisory ratings to such firms on a permanent basis.13

13 Concurrent with the issuance of this final LFI rating system, the Board adopted the RFI rating system for SLHCs that are depository in nature. See supra fn. 3. The RFI rating system will cease to apply to SLHCs with $100 billion or more in total consolidated assets upon the effective date of LFI rating system for such firms. The Board also continues to consider the appropriate regulatory regime for systemically important nonbank financial companies designated by the Financial Stability Oversight Council (FSOC) for supervision by the Federal Reserve.

B. Timing and Implementation

Under the proposal, the initial set of LFI ratings would have been assigned starting in 2018. Several commenters provided views regarding the timing and implementation of the final LFI rating system. For instance, commenters suggested that Federal Reserve delay implementation of the LFI rating system for firms with assets of less than $250 billion until the completion of regulatory reforms. Other commenters requested that the Board coordinate the implementation of the final LFI rating system with the related guidance setting forth attributes of effective boards and expectations for the management of business lines and independent risk management and controls, and the Federal Reserve provide more clarity regarding the implementation of the guidance.14 Another commenter requested that the Federal Reserve run a pilot program before implementing the final LFI rating system.

14 Comments related to implementation of the LFI rating system for FBOs are discussed below.

In light of the changes to the application of enhanced prudential standards under EGRRCPA, the Board is currently considering ways to tailor the regulatory and supervisory framework for firms that are not in the LISCC portfolio. Accordingly, in order to conduct that review and seek public comment on any proposed revisions to the Board's regulations, the Federal Reserve will continue to use the RFI rating system for ratings in 2019 for holding companies with assets of $100 billion or more and U.S. intermediate holding companies of foreign banking organizations that are not subject to the LISCC framework. The Federal Reserve will assign ratings using the final LFI rating system beginning in early 2020.15

15 In early 2020, banking organizations that are not LISCC firms will receive all three component ratings under the LFI rating system; following the initial rating assignment, updates to individual rating components may be assigned and communicated to the firm on a rolling basis, but at least annually.

For bank holding companies and U.S. IHCs of foreign banking organizations subject to the LISCC framework, the Federal Reserve will begin assigning ratings using the final LFI rating system in early 2019. In early 2019, LISCC firms will receive all three component ratings under the LFI rating system; following the initial rating assignment, updates to individual rating components may be assigned and communicated to the firm on a rolling basis, but at least annually.

The Board believes that it is important to have the LFI rating system become effective soon in order to align the supervisory rating system with the Board's current consolidated supervisory framework for large financial institutions. This alignment will enhance the clarity of the Board's supervisory program, as both the Board's supervisory assessment of a firm and its related assignment of the firm's ratings will directly relate with the three core areas of focus in the consolidated supervisory framework: Capital, liquidity, and governance and controls. For example, supervisory assessments of a firm's capital and liquidity can be prominently reflected in the ratings assigned under the LFI rating system, whereas such assessments are less easily communicated within the structure of the RFI rating system. To ensure that ratings are assigned in a consistent and fair manner, the Federal Reserve is implementing staff training and will undertake a multi-level review and vetting before ratings are assigned.

As noted above, the Board invited comment on two sets of guidance that related to the governance and controls component rating—the first established principles regarding effective boards of directors focused on the performance of a board's core responsibilities, and the second set forth core principles of effective senior management, the management of business lines, and independent risk management and controls for large financial institutions. The Board continues to consider comments on both proposals, and thus, is not adopting either set of guidance at this time. Given that the guidance establishing principles regarding effective boards of directors is not finalized, the Federal Reserve intends to rely primarily on principles set forth in SR letter 12-17/CA letter 12-14 and safety and soundness to assess the effectiveness of a firm's board of directors. Given that the management of business lines and independent risk management and controls guidance is not finalized, the Federal Reserve will rely on existing risk management guidance to assess the effectiveness of a firm's management of business lines and independent risk management and controls.16

16 Existing risk management guidance includes, but is not limited to, SR letter 95-51, “Rating the Adequacy of Risk Management Processes and Internal Controls at State Member Banks and Bank Holding Companies;” SR letter 03-5, “Amended Interagency Guidance on the Internal Audit Function and its Outsourcing;” SR letter 12-17/CA letter 12-14, “Consolidated Supervision Framework for Large Financial Institutions;” SR letter 10-6, “Interagency Policy Statement on Funding and Liquidity Risk Management,” SR letter 13-1/CA letter 13-1, “Supplemental Policy Statement on the Internal Audit Function and Its Outsourcing;” SR letter 13-19/CA letter 13-21, “Guidance on Managing Outsourcing Risk;” SR letter 15-18, “Supervisory Assessment of Capital Planning and Positions for LISCC Firms and Large and Complex Firms;” and SR letter 15-19, “Supervisory Assessment of Capital Planning and Positions for Large and Noncomplex Firms.” In addition, Regulation YY sets forth risk management requirements, including liquidity risk management requirements.

Reliance on other regulators

Commenters requested that the Federal Reserve rely to a greater extent on the supervisory evaluations conducted by other regulators, including both domestic and foreign supervisors. Coordination with other domestic regulators and foreign supervisory authorities is a critical component of the LFI supervisory program. Federal Reserve staff meets regularly with counterparts at domestic and foreign regulatory agencies that have primary supervisory responsibility with respect to a banking organization or its subsidiaries, or its foreign bank parent, in order to leverage work and ensure effective coordination. In assigning LFI component ratings under the final LFI rating system, the Federal Reserve will continue to rely to the fullest extent possible on applicable information and assessments developed by other relevant supervisors and functional regulators.

Application to U.S. IHCs

The proposed LFI rating system would have applied to U.S. IHCs of foreign banking organizations. Some commenters requested that the Board delay application of the LFI rating system to U.S. IHCs until the Board sought comment on governance and controls guidance designed specifically for U.S. IHCs. Commenters requested clarification on how the assignment of LFI ratings to U.S. IHCs would interact with other ratings assigned to the U.S. operations of foreign banking organizations (the combined U.S. operations assessment) and the ROCA rating for U.S. branches and agencies.

Under the principle of national treatment, the Federal Reserve generally applies standards to the U.S. operations of a foreign banking organization consistent with those that apply to similarly situated U.S. banking organizations. The U.S. operations of a foreign banking organization are subject to regulatory standards set forth in Regulation YY, and expectations related to capital planning and positions, liquidity risk management and positions, and governance and controls, that are parallel to those that apply to a U.S. bank holding company. Applying the final LFI rating system to U.S. IHCs of foreign banking organizations would be consistent with national treatment and the Board's approach to regulating and supervising foreign banking organizations.

As commenters note, the Board did not apply the guidance setting forth attributes of effective boards to U.S. IHCs, in recognition of the fact that a U.S. IHC is a subsidiary of a foreign banking organization. U.S. IHCs will not be subject to examinations solely focused on effectiveness of the U.S. IHC's board of directors.17 Rather, the Federal Reserve will indirectly assess the effectiveness of a U.S. IHC's board by considering whether weaknesses or deficiencies that are identified within the organization while conducting other supervisory work may be evidence of, or resulting from, governance-related oversight deficiencies. For example, governance-related oversight deficiencies could be noted in the context of a significant risk management or control weakness that is identified during an examination of capital planning or business line management.

17 However, the Federal Reserve may consider the effectiveness of the IHC's board of directors in connection with other examinations. For example, the Federal Reserve may consider governance-related oversight deficiencies in the context of a significant risk management or control weakness that is identified during an examination of capital planning or business line management.

The Board will continue to evaluate the U.S. branches of foreign banks under the ROCA system, and assign a single component rating to the foreign banking organization's U.S. operations. As noted in the preamble to the proposal, the Board is considering adjustments to the ratings for U.S. branches and the U.S. operations to better align with the LFI framework.

Commenters also requested clarity in how the LFI rating would impact the “well managed” status of a foreign banking organization that is a financial holding company. Under current law, a foreign banking organization that is a financial holding company must be well capitalized and must have a satisfactory composite rating of its U.S. branch and agency operations and a satisfactory rating of its U.S. combined operations, if one is given. As with the rating currently assigned to a U.S. IHC under the RFI system, the LFI rating assigned to the U.S. IHC would be an input into the rating of the combined U.S. operations of a foreign bank.

C. LFI Rating Components

Under the proposed LFI rating system, the Federal Reserve would have evaluated and assigned ratings for the following three components: Capital Planning and Positions; Liquidity Risk Management and Positions; and Governance and Controls. The final LFI rating system adopts these component categories as proposed.

Capital Planning and Positions

As proposed, the Capital Planning and Positions rating would have encompassed assessments of (i) the effectiveness of the governance and planning processes used by a firm to determine the amount of capital necessary to cover risks and exposures, and to support activities through a range of conditions; and (ii) the sufficiency of a firm's capital positions to comply with applicable regulatory requirements and to support the firm's ability to continue to serve as a financial intermediary through a range of conditions.

Several commenters sought clarification regarding the relationship between a firm's compliance with regulatory capital requirements and a firm's Capital Planning and Positions rating. In addition, some commenters asserted that receipt of a non-objection to a capital plan should result in (or create the presumption of) a firm receiving a “Satisfactory” rating for the Capital Planning and Positions component under the LFI rating system.

The final LFI rating system adopts the description of the Capital Planning and Positions component rating used in the proposal. A firm's capital rating under the LFI rating system will reflect a broad assessment of the firm's capital planning and positions, based on horizontal reviews and firm-specific supervisory work focused on capital planning and positions. In consolidating supervisory findings into a comprehensive assessment of a firm's capital planning and positions, the Federal Reserve will take into account the materiality of a firm's outstanding and newly identified supervisory issues.

A firm's compliance with minimum regulatory capital requirements will be considered in assigning the firm's Capital Planning and Positions component rating; however, the Federal Reserve may determine that a firm does not meet expectations regarding its capital position in light of its idiosyncratic activities and risks, even if the firm meets minimum regulatory capital requirements. Any findings from supervisory stress testing, such as CCAR or similar activities, will represent inputs into the Capital Planning and Positions component rating. However, with respect to any firm that may be subject to a qualitative review of its capital planning practices, there is no automatic link between the results of that review and the firm's capital rating.

Some commenters argued that the Board should discontinue its practice of publicly objecting or not-objecting to a firm's capital plan. Last year, the Board exempted firms with less than $250 billion in assets and less than $75 billion in nonbank assets from the CCAR qualitative assessment, and in the recent stress capital buffer proposal, the Board sought comments on potential changes to the CCAR qualitative assessment.18 The Board is currently in the process of evaluating these comments.

18 83 FR 9308 (February 3, 2017); 83 FR 18160 (April 25, 2018).

In addition, commenters noted that the Board should clarify that the final LFI rating system does not create any new qualitative standards for capital planning, and others requested that the Board separately seek comment on the capital planning expectations included in SR letters 15-18 and 15-19. Consistent with the commenters' request, the Board confirms that the final LFI rating system does not create any new capital planning expectations applicable to LFIs. When the Board adopted SR letters 15-18 and 15-19, it did not seek comment on those letters, as they largely consolidated the Federal Reserve's existing capital planning guidance in one place. To the extent the Board considers adjustments to those letters in the future, the Board will take commenters' views into account.

Liquidity Risk Management and Positions

As proposed, the Liquidity Risk Management and Positions component rating would have encompassed assessments of (i) the effectiveness of a firm's governance and risk management processes used to determine the amount of liquidity necessary to cover risks and exposures, and to support activities through a range of conditions; and (ii) the sufficiency of a firm's liquidity positions to comply with applicable regulatory requirements and to support the firm's ongoing obligations through a range of conditions.

Several commenters requested that the Board clarify how the liquidity rating would be assigned and clarify the linkage between a firm's rating and its compliance with the minimum liquidity requirements. The final ratings system adopts the description of the Liquidity Risk Management and Positions component rating used in the proposal without change. In assessing the liquidity risk management and position of a banking organization, the Federal Reserve evaluates each firm's risk management practices by reviewing the processes that firms use to identify, measure, monitor, and manage liquidity risk and make funding decisions, and evaluating the firm's compliance with the liquidity risk management requirements of Regulation YY. The Federal Reserve evaluates a firm's liquidity positions against applicable regulatory requirements, and assesses the firm's ability to support its obligations through other means, such as its funding concentrations. A firm's liquidity rating will reflect the materiality of issues identified through the supervisory process.

In addition, commenters requested additional detail on the relationship between the Liquidity Risk Management and Positions rating of a LISCC firm and its performance in the Comprehensive Liquidity Assessment Review (CLAR). As for all component ratings, horizontal and firm-specific examination work conducted under the LISCC liquidity program, which is inclusive of the horizontal work covered under the CLAR, will represent a material input into a firm's liquidity rating. Unlike CCAR, the LISCC liquidity program's assessment does not result in an objection or non-objection ; rather, it results in supervisory findings communicated to the firm, which may include “matters requiring attention” and “matters requiring immediate attention,” as applicable.

Governance and Controls

The proposed Governance and Controls component rating would have evaluated the effectiveness of a firm's (i) board of directors,19 (ii) management of business lines and independent risk management and controls,20 and (iii) recovery planning (for domestic LISCC firms only).21

19 “Board” or “board of directors” also refers to the equivalent to a board of directors, as appropriate, as well as committees of the board of directors or the equivalent thereof, as appropriate.

20 The final LFI rating system uses the term “management of business lines” instead of “management of core business lines,” in order to align with the proposed guidance on the management of business lines and independent risk management and controls.

21 At this time, recovery planning expectations only apply to domestic bank holding companies subject to the Federal Reserve's LISCC supervisory framework. See SR letter 14-8, “Consolidated Recovery Planning for Certain Large Domestic Bank Holding Companies.” Should the Federal Reserve expand the scope of recovery planning expectations to encompass additional firms, this rating will reflect such expectations for the broader set of firms.

There are eight domestic firms in the LISCC portfolio: (1) Bank of America Corporation; (2) Bank of New York Mellon Corporation; (3) Citigroup, Inc.; (4) Goldman Sachs Group, Inc.; (5) JP Morgan Chase & Co.; (6) Morgan Stanley; (7) State Street Corporation; and (8) Wells Fargo & Company.

This component rating would have included consideration of a firm's compliance practices. One commenter suggested that the rating take into account only compliance matters that would have a material impact on a firm's financial and operational strength and resiliency. The Board expects all firms to comply fully with applicable laws and regulations, including those related to consumer protection. In assigning a supervisory rating, the Board will take into account the materiality of outstanding and identified supervisory issues, including the extent to which a matter would have a material impact on a firm's financial and operational strength and resiliency.

The proposed Governance and Controls component rating would have included a consideration of recovery planning for domestic LISCC firms, given the heightened risks that LISCC firms present to financial stability. One commenter suggested that the governance and controls rating not include recovery planning for domestic LISCC firms, because related supervisory expectations are already reflected in other aspects of the LFI rating system. The final LFI rating system maintains consideration of recovery planning in assessing the governance and controls of a LISCC firm, as effective recovery planning practices are central to ensuring that a LISCC firm has sufficient financial and operational strength to continue operations through a range of conditions.

The Board requested comment on whether resolution planning should also be a component of, or otherwise factored into, the LFI rating system. Several commenters argued against inclusion of resolution planning, stating, for example, that adding a separate component rating for resolution planning would be duplicative in light the current public deficiency findings under the resolution plan rule. One commenter supported the inclusion of resolution planning in the LFI rating system.

The Board has determined not to include a separate component rating for a firm's resolution planning as part of the final LFI rating system. The Board will continue to consider whether the LFI rating system should be modified in the future to include an assessment of the sufficiency of a firm's resolution planning efforts.

D. LFI Rating Scale

Under the proposed LFI rating system, ratings would have been assigned based on a four-point scale, with the following categories: Satisfactory/Satisfactory Watch, Deficient-1, and Deficient-2. One commenter expressed concern that the reduction in the number of ratings categories from five, as in the current RFI framework, to four, would result in the new rating framework being less flexible and nuanced, and lead to inadvertent rating downgrades.

A four-category rating scale is intended to increase the usability of the scale—under the RFI rating system, the highest rating of “1” and the lowest rating of “5” were rarely used when rating LFIs. Further, the “Conditionally Meets Expectations” rating category enables the Federal Reserve to identify certain material issues at a firm and provide a firm with notice and the ability to fix those issues before the firm experiences regulatory consequences as a result of the ratings downgrade.

The final LFI rating system adopts a similar four-category scale, but uses different terminology to improve the descriptiveness of the rating categories. Specifically, the final rating categories are: Broadly Meets Expectations, Conditionally Meets Expectations, Deficient-1, and Deficient-2. The final LFI rating system also clarifies the definitions within each category to provide additional guidance to examiners and provide transparency to firms about the calibration of each category.

Several commenters also expressed the need for the use of additional quantitative measures improve transparency and consistency in how ratings are derived. The Federal Reserve will continue to use quantitative measures, together with supervisory judgment, to inform a comprehensive assessment of a firm's Capital, Liquidity, and Governance and Controls.

Broadly Meets Expectations

In the proposal, the highest rating category was “Satisfactory.” A “Satisfactory” rating would have indicated that a firm is considered safe and sound and broadly meets supervisory expectations.

The final LFI rating system renames the rating category as “Broadly Meets Expectations,” to align more closely with the underlying definition of the rating category.22 As with the proposal, the final ratings definition for “Broadly Meets Expectations” provides that a firm may have supervisory issues requiring corrective action; however, these issues are unlikely to present a threat to the firm's ability to maintain safe-and-sound operations through a range of conditions.

22 References to “safe and sound” or “safety and soundness” in the LFI rating system apply to a firm's consolidated organization as well as to its critical operations and banking offices.

Two commenters suggested that the rating scale should include a higher rating above the “Satisfactory” designation, similar to the “Strong” rating utilized with the RFI, CAMELS, and other supervisory rating systems. The final LFI rating system does not include a “Strong” rating, which may suggest that the Federal Reserve expects firms to exceed, not simply meet, supervisory expectations. In addition, a “Strong” rating would not enhance or clarify supervisory communications, as a “Strong” rating would have no supervisory consequences.23

23 One comment requested removal of the term “strong,” which was used to describe practices related to controls. To provide the clarity requested by the commenter, the final terminology has been changed to use the term “effective.”

One commenter stated that the rule should clarify the circumstances under which MRAs or MRIAs would trigger a downgrade from the “Satisfactory” rating. As noted above, in consolidating supervisory findings into a comprehensive assessment in each category, the Board will take into account the materiality of a firm's outstanding and newly identified supervisory issues. While a given ratings assessment will depend on the circumstances, the LFI rating scale is designed to clarify the relationship between supervisory issues and deficiencies, and a firm's progress in remediation and mitigation efforts.

Conditionally Meets Expectations

In the proposed LFI rating system, the second highest rating category was “Satisfactory Watch.” This rating would have indicated that a firm was generally considered safe and sound; however, certain issues were sufficiently material that, if not resolved in a timely manner in the normal course of business, they would put the firm's prospects for remaining safe and sound through a range of conditions at risk. As noted in the proposal, the “Satisfactory Watch” rating was intended to be consistent with the Federal Reserve's practice of providing notice to firms that they are likely to be downgraded if identified weaknesses are not resolved in a timely manner.

The preamble to the proposal noted that the “Satisfactory Watch” rating was not intended to be used for a prolonged period; rather, firms would have had a specified timeframe to fully resolve issues leading to that rating (as is the case with all supervisory issues), but generally no longer than 18 months. Several commenters noted that many supervisory issues take longer than 18 months to resolve, and that resolution of certain issues requires substantial infrastructure investment and changes in processes and controls. As such, these commenters argued that the specified remediation timeframes in the “Satisfactory Watch” rating should be based on the specific facts and circumstances of the supervisory issue(s) in question, rather than limited to an 18-month period. These commenters also argued that a firm should not be downgraded provided the firm makes good faith efforts to remediate the issues and progress is made.

As in the proposal, the final ratings framework states that the Federal Reserve does not intend for a firm to be rated “Conditionally Meets Expectations” for a prolonged period. However, unlike the proposal, the final ratings framework does not establish a fixed timeline for how long a firm can be rated “Conditionally Meets Expectations.” Instead, the final ratings framework reflects an understanding that timelines will be issues-specific, noting that the Federal Reserve will work with the firm to develop an appropriate timeframe during which the firm would be expected to resolve each supervisory issue leading to the “Conditionally Meets Expectations” rating. Further, the final ratings framework reflects an understanding that completion and validation of remediation activities for selected supervisory issues—such as those involving information technology modifications—will require an extended time horizon. In all instances, appropriate and effective risk mitigation techniques must be utilized in the interim to maintain safe-and-sound operations under a range of conditions until remediation activities are completed, validated, and fully operational.

One commenter recommended that the “Satisfactory Watch” rating should be permanent, rather than temporary, while another argued that the “Satisfactory Watch” rating should be used infrequently. The final LFI rating system acknowledges there are circumstances when a firm may be rated “Conditionally Meets Expectations” for a longer period of time if, for instance, the firm is close to completing resolution of the supervisory issues leading to the “Conditionally Meets Expectations” rating, but new issues may be identified that, taken alone, would be consistent with a “Conditionally Meets Expectations” rating. In this event, the firm may continue to be rated “Conditionally Meets Expectations,” provided the new issues do not reflect a pattern of deeper or prolonged capital planning or position weaknesses consistent with a “Deficient” rating.

The proposal would have provided that “Satisfactory Watch” would be appropriate when a firm could resolve the issue in a timely manner in the normal course of business. Commenters requested clarification on expectations regarding “normal course of business.” The final LFI rating system clarifies that “normal course of business” means that a firm has the ability to resolve these issues through measures that do not require a material change to the firm's business model or financial profile, or its governance, risk management, or internal control structures or practices.

Several commenters also argued that a firm rated “Deficient” should be upgraded to the “Satisfactory Watch” rating if the firm has remediated identified deficiencies but a validation process had not yet been completed. As indicated in the Deficient-1 section below, the final LFI framework indicates that a firm previously rated “Deficient” may be upgraded to “Conditionally Meets Expectations” if the firm's remediation and mitigation activities are sufficiently advanced so that its prospects for remaining safe and sound are no longer at significant risk, even if the firm has outstanding supervisory issues or is subject to an active enforcement action.

Deficient-1

In the proposal, the third rating category was “Deficient-1,” which would have indicated that, although the firm's current condition is not considered to be materially threatened, there were financial and/or operational deficiencies that put its prospects for remaining safe and sound through a range of conditions at significant risk. The final ratings framework maintains the name of the third rating category.

Under the proposed LFI rating system, a firm that received a rating of “Deficient-1” or “Deficient-2” in any component rating would not be considered “well managed” for purposes of the Bank Holding Company Act (BHC Act).24 Several commenters suggested that the “well managed” determination should be made on the basis of an assessment of the firm as a whole, rather than the automatic consequence of any one component rating. One commenter argued that the separate, standalone composite rating should form the sole basis for determining a firm's “well managed” status.

24 For purposes of determining whether a firm is considered to be “well managed” under section 2(o)(9) of the BHC Act, the Federal Reserve considers the three component ratings, taken together, to be equivalent to assigning a standalone composite rating. In addition, the RFI rating system designates the “Risk Management” rating as the “management” rating when making “well managed” determinations under section 2(o)(9)(A)(ii) of the BHC Act. See SR letter 04-8. In contrast, the LFI rating system would not designate any of the three component ratings as a “management” rating, because each component evaluates different areas of the firm's management.

Conditioning a firm's “well managed” status on all three rating categories reflects the judgment that a banking organization is not in satisfactory condition overall unless it is considered sound in each of the key areas of capital, liquidity, and governance and controls. Each rating category includes assessments of key aspects of a firm's practices and capabilities, including management, that are necessary to operate in a safe-and-sound manner. A “Deficient” rating in any of the components reflects the supervisory conclusion that financial or operational deficiencies have placed the firm's safety and soundness at significant risk, which would not warrant a firm being deemed “well managed.” Accordingly, the final LFI rating system maintains the proposed approach to determining whether a firm is “well managed.”

Under current law, a firm must receive a “Satisfactory” risk management and composite rating in order to qualify as “well managed.” Several commenters argued that the proposed rating scale would introduce a more rigid standard compared with the RFI rating system, potentially making LFIs less likely to be considered “well managed.” In the Board's view, any rigidity is balanced by the introduction of the “Conditionally Meets Expectations” rating, which provides notice to firms that they are likely to be downgraded if identified weaknesses are not resolved in a timely manner.

The proposal noted that a “Deficient-1” component rating would often be an indication that the firm should be subject to either an informal or formal enforcement action, and may also result in the designation of the firm as being in “troubled condition.” 25 Several commenters requested clarity under what circumstances a “Deficient-1” rating would result in “troubled condition” status or a formal enforcement action.

25See 12 CFR 225.71(d).

Consistent with commenters' views, the final LFI rating system reflects that there is no presumption that a firm rated “Deficient-1” would be deemed to be in “troubled condition.” Whether a firm rated “Deficient-1” receives a “troubled condition” designation will be determined by the facts and circumstances at that firm. However, firms rated “Deficient-1” due to financial weaknesses in either capital or liquidity would be more likely to be deemed in “troubled condition” than firms rated “Deficient-1” due solely to issues of governance or controls.

While a commenter asked that a “Deficient-1” rating be an automatic bar to new or expansionary activity, others suggested that firms rated “Deficient-1” not be subject to any restrictions on growth. Consistent with the proposal, receiving a “Deficient-1” rating under the final LFI rating system would result in automatic consequences for a firm's “well managed” status, which would limit the firm's ability to engage in new or expansionary nonbanking activities. Further, as with the proposal, a “Deficient-1” rating in the final LFI rating system could be a barrier for a firm seeking the Federal Reserve's approval of a proposal to engage in new or expansionary activities, unless the firm can demonstrate that (i) it is making meaningful, sustained progress in resolving identified deficiencies and issues; (ii) the proposed new or expansionary activities would not present a risk of exacerbating current deficiencies or issues or lead to new concerns; and (iii) the proposed activities would not distract the firm from remediating current deficiencies or issues.

Deficient-2

A “Deficient-2” rating indicates that financial and/or operational deficiencies materially threaten the firm's safety and soundness, or have already put the firm in an unsafe and unsound condition. The proposal noted that a firm with a “Deficient-2” component rating would be required to immediately (i) implement comprehensive corrective measures sufficient to restore and maintain appropriate capital planning capabilities and adequate capital positions; and (ii) demonstrate the sufficiency, credibility and readiness of contingency planning in the event of further deterioration of the firm's financial or operational strength or resiliency. It also noted that there is a strong presumption that a firm rated “Deficient-2” will be subject to a formal enforcement action by the Federal Reserve, and that the Federal Reserve would be unlikely to approve a proposal from a firm to engage in new or expansionary activities.

The final LFI rating system adopts the “Deficient-2” ratings category without change.

E. General Comments Eliminating Subcomponent Ratings

The proposed LFI rating system described the areas of assessment under each component rating, but would not have assigned separate subcomponents for each area of assessment. A few commenters recommended that each of the three component ratings include subcomponent ratings, as used in the RFI rating system. These commenters argued that subcomponent ratings aid supervisory staff to consistently apply the component rating across institutions, and allow firms to more easily identify, communicate, and correct deficiencies across the organization.

Communicating a single rating in each component is intended to reinforce the Board's view that the strength of a firm's capital and liquidity position is integrated with the effectiveness the firm's capital planning and liquidity risk management, respectively, and the strength of a firm's risk management depends on the effectiveness of the board oversight. In developing the rating, the Federal Reserve will rely on firm-specific and horizontal examination work. Throughout the year, and in connection with its rating, firms will receive feedback relating to the supervisory activities that inform the ratings, which will provide firms with specific feedback relating to the elements of the rating.

Composite Rating

Several commenters asserted that the LFI rating system should include a separate, standalone composite rating in addition to the three component ratings. These commenters asserted that a composite rating would provide a fuller view of the health of each institution.

Unlike other supervisory rating systems, including the RFI rating system, the Federal Reserve will not assign a standalone composite rating under the LFI rating system. As noted in the proposal, assigning a standalone composite rating is not necessary because the three component ratings are designed to clearly communicate supervisory assessments and associated consequences for each of the core areas (capital, liquidity, and governance and controls). Further, the components identify those core areas that are necessary and critical to a firm's strength and resilience. It is unlikely that the assignment of a standalone composite rating would convey new or additional information regarding these supervisory assessments not already communicated by the three component ratings, and a standalone composite rating could dilute the clarity and impact of the component ratings. As such, the final LFI rating system does not include a separate standalone composite rating.

Disclosure and Challenge to Ratings

In accordance with the Federal Reserve's regulations governing confidential supervisory information,26 ratings assigned under the proposed LFI rating system would have been communicated by the Federal Reserve to the firm but not disclosed publicly. One commenter requested that LFI rating components be publicly disclosed, as the public would benefit from additional supervisory disclosure regarding individual firms. The Board has traditionally maintained the confidentiality of supervisory ratings in order to preserve candor in communication between supervised institutions and the Board. For this reason, in accordance with the Federal Reserve's regulations governing confidential supervisory information, ratings assigned under the LFI rating system will be communicated by the Federal Reserve to the firm, but individual ratings will not be disclosed publicly. The Federal Reserve will continue to think broadly in considering ways to enhance transparency across its processes and communications in support of improved supervisory approaches and outcomes.

26See 12 CFR 261.20.

In addition, some commenters indicated that there should be a more effective process for firms to challenge and seek review of supervisory findings, such as additional opportunities to respond to adverse findings by examiners, and meetings with the Federal Reserve. The Federal Reserve is committed to engaging in ongoing dialogue with banking organizations regarding supervisory findings to ensure that firms understand supervisory expectations and that the Federal Reserve understands the way that firms think about their business and risks. The Board also is committed to maintaining an effective independent appellate process to allow institutions to seek review of material supervisory determinations. The Board recently issued a proposal that is out for comment and is currently considering comments on that proposal.27

27See 83 FR 8391 (February 27, 2018).

V. Changes to Existing Regulations

References to holding company ratings are included in a number of the Federal Reserve's existing regulations. In certain cases, the regulations are narrowly constructed such that they contemplate only the assignment of a standalone composite rating using a numerical rating scale. This is consistent with the current RFI rating system but is not compatible with the LFI rating system. Three provisions in the Federal Reserve's existing regulations are written in this manner, including two in Regulation K and one in Regulation LL.

In Regulation K, § 211.2(z) includes a definition of “well managed” which, in part, requires a bank holding company to have received a composite rating of 1 or 2 at its most recent examination or review; and § 211.9(a)(2) requires an investor (which by definition can be a bank holding company) to have received a composite rating of at least 2 at its most recent examination in order to make investments under the general consent or limited general consent procedures contained in § 211.9(b) and (c).

In Regulation LL, § 238.54(a)(1) restricts savings and loan holding companies from commencing certain activities without the Federal Reserve's prior approval unless the company received a composite rating of 1 or 2 at its most recent examination.

To ensure that the Federal Reserve's regulations are consistent and compatible with all aspects of both the RFI rating system as well as the LFI rating system, the Federal Reserve is amending those three regulatory provisions so that they will apply to entities which receive numerical composite ratings as well as to entities which do not receive numerical composite ratings (including firms subject to the LFI rating system).28 To satisfy the requirements of those provisions, firms that do not receive numerical composite ratings will have to be considered satisfactory under the LFI rating system. To be considered satisfactory, a firm would have to be rated “Broadly Meets Expectations” or “Conditionally Meets Expectations” for each component of the LFI rating system; a firm which is rated “Deficient-1” or lower for any component would not be considered satisfactory. This standard applies to any provision contained in the Federal Reserve's regulations, which requires or refers to a firm having a satisfactory composite rating.

28 The Board may propose additional necessary revisions to its regulations resulting from the adoption of a final LFI rating system.

VI. Comparison of the RFI and LFI Rating Systems

As compared to the RFI rating system, the proposed LFI rating system did not include an explicit assessment of a banking organization's ability to protect depository institutions from the activities of non-depository or capital market subsidiaries. The commenter suggested the Board revise the proposal to recognize the importance of this concept.

In response to the commenter, the final LFI rating system acknowledges that a banking organization is expected to ensure that the consolidated organization, including its critical operations and banking offices, remains safe and sound through a range of potentially stressful conditions.

The final LFI rating system includes several structural changes from the RFI rating system. The following table provides a broad comparison between the two rating systems.

RFI rating system LFI rating system R—Risk Management An evaluation of the ability of the bank holding company's board of directors and senior management to identify, measure, monitor, and control risk Assessment of the effectiveness of a firm's governance and risk management practices is central to the Governance and Controls component rating. The Governance and Controls component rating evaluates a firm's effectiveness in aligning strategic business objectives with risk management capabilities; maintaining effective and independent risk management and control functions, including internal audit; promoting compliance with laws and regulations, including those related to consumer protection; and otherwise providing for the ongoing resiliency of the firm. The rating is supported by four subcomponent ratings
  • • Board and Senior Management Oversight
  • • Policies, Procedures, and Limits
  • • Risk Monitoring and Management Information Systems
  • • Internal Controls
  • Governance and risk management practices specifically related to maintaining financial strength and resilience are also incorporated into the Capital Planning and Positions and Liquidity Risk Management and Positions component ratings.
    F—Financial Condition An evaluation of the consolidated organization's financial strength Assessment of a firm's financial strength and resilience is specifically evaluated through the Capital Planning and Positions and Liquidity Risk Management and Positions component ratings. The rating is supported by four subcomponent ratings
  • • Capital Adequacy
  • • Asset Quality
  • • Earnings
  • • Liquidity
  • These component ratings also assess the effectiveness of associated planning and risk management processes, and the sufficiency of related positions.
  • Although asset quality and earnings are not rated separately, they continue to be important elements in assessing a firm's safety and soundness and resiliency, and are important considerations within each of the LFI component ratings.
  • I—Impact An assessment of the potential impact of the firm's nondepository entities on its subsidiary depository institution(s) Although a separate “Impact” rating will not be assigned, the LFI rating system will assess a firm's ability to protect the safety and soundness of its subsidiary depository institutions, including whether the firm can provide financial and operational strength to its subsidiary depository institutions.29 D—Depository Institutions Generally reflects the composite CAMELS rating assigned by the primary supervisor of the subsidiary depository institution(s).30 The LFI rating system would not assign a separate rating for a firm's depository institution subsidiaries. The Federal Reserve will continue to rely to the fullest extent possible on supervisory assessments developed by the primary supervisor of the subsidiary depository institution(s). C—Composite Rating The overall composite assessment of the bank holding company as reflected by the R, F, and I ratings, and supported by examiner judgment with respect to the relative importance of each component to the safe and sound operation of the bank holding company. A standalone composite rating will not be assigned. The three LFI component ratings are designed to clearly communicate supervisory assessments and associated consequences for each of the core areas (capital, liquidity, and governance and controls) that are considered critical to an LFI's strength and resilience.
  • For purposes of determining whether a firm is “well managed,” each component must be rated either “Broadly Meets Expectations” or “Conditionally Meets Expectations” in order for a firm to be deemed “well managed.”
  • VII. Regulatory Analysis

    29See Sections 616 of Dodd-Frank Act (financial strength), 12 CFR 225.4 of the Board's Regulation Y, and 12 CFR 238.8 of the Board's Regulation LL.

    30See SR letter 96-38, “Uniform Financial Institutions Rating System,” at http://www.federalreserve.gov/boarddocs/srletters/1996/sr9638.htm.

    A. Paperwork Reduction Act

    There is no collection of information required by this proposal that would be subject to the Paperwork Reduction Act of 1995, 44 U.S.C. 3501 et seq.

    B. Regulatory Flexibility Analysis

    The Regulatory Flexibility Act (RFA), 5 U.S.C. 601 et seq., generally requires that, in connection with a proposed rulemaking, an agency prepare and make available for public comment an initial regulatory flexibility analysis (IRFA). The Board solicited public comment on the LFI rating system in a notice of proposed rulemaking and has since considered the potential impact of this final rule on small entities in accordance with section 604 of the RFA. Based on the Board's analysis, and for the reasons stated below, the Board believes the final rule will not have a significant economic impact on a substantial number of small entities.

    The RFA requires an agency to prepare a final regulatory flexibility analysis (FRFA) unless the agency certifies that the rule will not, if promulgated, have a significant economic impact on a substantial number of small entities. The FRFA must contain: (1) A statement of the need for, and objectives of, the rule; (2) a statement of the significant issues raised by the public comments in response to the IRFA, a statement of the agency's assessment of such issues, and a statement of any changes made in the proposed rule as a result of such comments; (3) the response of the agency to any comments filed by the Chief Counsel for Advocacy of the Small Business Administration in response to the proposed rule, and a detailed statement of any changes made to the proposed rule in the final rule as a result of the comments; (4) a description of an estimate of the number of small entities to which the rule will apply or an explanation of why no such estimate is available; (5) a description of the projected reporting, recordkeeping and other compliance requirements of the rule, including an estimate of the classes of small entities which will be subject to the requirement and type of professional skills necessary for preparation of the report or record; and (6) a description of the steps the agency has taken to minimize the economic impact on small entities, including a statement for selecting or rejecting the other significant alternatives to the rule considered by the agency.

    The final rule adopts a new holding company rating system for large financial institutions, and amend the Board's Regulations K and LL to ensure the Board's regulations are compatible with all aspects of the LFI rating system, but will not change the operation of those regulations for any entity that is not subject to the LFI rating system. Commenters did not raise any issues in response to the IRFA. In addition, the Chief Counsel for Advocacy of the Small Business Administration did not file any comments in response to the proposed rule.

    Under regulations issued by the Small Business Administration (SBA), a “small entity” includes a depository institution, bank holding company, or savings and loan holding company with assets of $550 million or less (small banking organizations). As discussed in the SUPPLEMENTARY INFORMATION, the final rule will apply to all bank holding companies with total consolidated assets of $100 billion or more; all non-insurance, non-commercial savings and loan holding companies with total consolidated assets of $100 billion or more; and U.S. intermediate holding companies of foreign banking organizations with total consolidated assets of $50 billion or more.

    Companies that are subject to the final rule therefore substantially exceed the $550 million asset threshold at which a banking entity is considered a “small entity” under SBA regulations. Because the final rule does not apply to any company with assets of $550 million or less, the final rule would not apply to any “small entity” for purposes of the RFA.

    There are no projected reporting, recordkeeping, or other compliance requirements associated with the final rule. As discussed above, the final rule does not apply to small entities.

    The Board does not believe that the final rule duplicates, overlaps, or conflicts with any other Federal Rules. In addition, the Board does not believe there are significant alternatives to the final rule that have less economic impact on small entities. In light of the foregoing, the Board does not believe the final rule will have a significant economic impact on a substantial number of small entities.

    C. Solicitation of Comments on Use of Plain Language

    Section 722 of the Gramm-Leach-Bliley Act requires the Board to use plain language in all proposed and final rules published after January 1, 2000. The Board received no comments on these matters and believes that the final rule is written plainly and clearly.

    List of Subjects 12 CFR Part 211

    Exports, Federal Reserve System, Foreign banking, Holding companies, Investments, Reporting and recordkeeping requirements.

    12 CFR Part 238

    Administrative practice and procedure, Banks, Banking, Federal Reserve System, Holding companies, Reporting and recordkeeping requirements.

    Authority and Issuance

    For the reasons stated in the preamble, the Board amends 12 CFR parts 211 and 238 as follows:

    PART 211—INTERNATIONAL BANKING OPERATIONS (REGULATION K) 1. The authority citations for part 211 continues to read as follows: Authority:

    12 U.S.C. 221 et seq., 1818, 1835a, 1841 et seq., 3101 et seq., 3901 et seq., and 5101 et seq.; 15 U.S.C. 1681s, 1681w, 6801 and 6805.

    2. Section 211.2 is amended by revising paragraph (z) to read as follows:
    § 211.2 Definitions.

    (z) Well managed means that the Edge or agreement corporation, any parent insured bank, and the bank holding company either received a composite rating of 1 or 2 or is considered satisfactory under the applicable rating system, and has at least a satisfactory rating for management if such a rating is given, at their most recent examination or review.

    3. Section 211.9 is amended by revising paragraph (a)(2) to read as follows:
    § 211.9 Investment procedures.

    (a) * * *

    (2) Composite rating. Except as the Board may otherwise determine, in order for an investor to make investments under the general consent or limited general consent procedures of paragraphs (b) and (c) of this section, at the most recent examination the investor and any parent insured bank must have either received a composite rating of at least 2 or be considered satisfactory under the applicable rating system.

    PART 238—SAVINGS AND LOAN HOLDING COMPANIES (REGULATION LL) 4. The authority citations for part 238 continues to read as follows: Authority:

    5 U.S.C. 552, 559; 12 U.S.C. 1462, 1462a, 1463, 1464, 1467, 1467a, 1468, 1813, 1817, 1829e, 1831i, 1972; 15 U.S.C. 78l.

    5. Section 238.54 is amended by revising paragraph (a)(1) to read as follows:
    § 238.54 Permissible bank holding company activities of savings and loan holding companies.

    (a) * * *

    (1) The holding company received a rating of satisfactory or above prior to January 1, 2008, or thereafter, either received a composite rating of “1” or “2” or be considered satisfactory under the applicable rating system in its most recent examination, and is not in a troubled condition as defined in § 238.72, and the holding company does not propose to commence the activity by an acquisition (in whole or in part) of a going concern; or

    Note:

    The following appendix will not appear in the Code of Federal Regulations.

    Appendix A—Text of Large Financial Institution Rating System A. Overview

    Each large financial institution (LFI) is expected to ensure that the consolidated organization (or the combined U.S. operations in the case of foreign banking organizations), including its critical operations and banking offices, remain safe and sound and in compliance with laws and regulations, including those related to consumer protection.1 The LFI rating system provides a supervisory evaluation of whether a covered firm possesses sufficient financial and operational strength and resilience to maintain safe-and-sound operations through a range of conditions, including stressful ones.2 The LFI rating system applies to bank holding companies with total consolidated assets of $100 billion or more; all non-insurance, non-commercial savings and loan holding companies with total consolidated assets of $100 billion or more; and U.S. intermediate holding companies of foreign banking organizations with combined U.S. assets of $50 billion or more established pursuant to the Federal Reserve's Regulation YY.3

    1 See SR letter 12-17/CA letter 12-14, “Consolidated Supervisory Framework for Large Financial Institutions,” at http://www.federalreserve.gov/bankinforeg/srletters/sr1217.htm.

    Hereinafter, when “safe and sound” or “safety and soundness” is used in this framework, related expectations apply to the consolidated organization and the firm's critical operations and banking offices.

    “Critical operations” are a firm's operations, including associated services, functions and support, the failure or discontinuance of which, in the view of the firm or the Federal Reserve, would pose a threat to the financial stability of the United States.

    “Banking offices” are defined as U.S. depository institution subsidiaries, as well as the U.S. branches and agencies of foreign banking organizations.

    2 “Financial strength and resilience” is defined as maintaining effective capital and liquidity governance and planning processes, and sufficiency of related positions, to provide for the continuity of the consolidated organization (including its critical operations and banking offices) through a range of conditions.

    “Operational strength and resilience” is defined as maintaining effective governance and controls to provide for the continuity of the consolidated organization (including its critical operations and banking offices) and to promote compliance with laws and regulations, including those related to consumer protection, through a range of conditions.

    References to “financial or operational” weaknesses or deficiencies implicate a firm's financial or operational strength and resilience.

    3 Total consolidated assets will be calculated based on the average of the firm's total consolidated assets in the four most recent quarters as reported on the firm's quarterly financial reports filed with the Federal Reserve. A firm will continue to be rated under the LFI rating system until it has less than $95 billion in total consolidated assets, based on the average total consolidated assets as reported on the firm's four most recent quarterly financial reports filed with the Federal Reserve. As noted in the proposal, the Federal Reserve may determine to apply the RFI rating system or another applicable rating system in certain limited circumstances.

    The LFI rating system is designed to:

    • Fully align with the Federal Reserve's current supervisory programs and practices, which are based upon the LFI supervision framework's core objectives of reducing the probability of LFIs failing or experiencing material distress and reducing the risk to U.S. financial stability;

    • Enhance the clarity and consistency of supervisory assessments and communications of supervisory findings and implications; and

    • Provide transparency related to the supervisory consequences of a given rating.

    The LFI rating system is comprised of three components:

    Capital Planning and Positions: An evaluation of (i) the effectiveness of a firm's governance and planning processes used to determine the amount of capital necessary to cover risks and exposures, and to support activities through a range of conditions and events; and (ii) the sufficiency of a firm's capital positions to comply with applicable regulatory requirements and to support the firm's ability to continue to serve as a financial intermediary through a range of conditions.

    Liquidity Risk Management and Positions: An evaluation of (i) the effectiveness of a firm's governance and risk management processes used to determine the amount of liquidity necessary to cover risks and exposures, and to support activities through a range of conditions; and (ii) the sufficiency of a firm's liquidity positions to comply with applicable regulatory requirements and to support the firm's ongoing obligations through a range of conditions.

    Governance and Controls: An evaluation of the effectiveness of a firm's (i) board of directors,4 (ii) management of business lines and independent risk management and controls,5 and (iii) recovery planning (only for domestic firms that are subject to the Board's Large Institution Supervision Coordinating Committee (LISCC) Framework).6 This rating assesses a firm's effectiveness in aligning strategic business objectives with the firm's risk appetite and risk management capabilities; maintaining effective and independent risk management and control functions, including internal audit; promoting compliance with laws and regulations, including those related to consumer protection; and otherwise planning for the ongoing resiliency of the firm.7

    4 References to “board” or “board of directors” in this framework includes the equivalent to a board of directors, as appropriate, as well as committees of the board of directors or the equivalent thereof, as appropriate.

    At this time, recovery planning expectations only apply to domestic bank holding companies subject to the Federal Reserve's LISCC supervisory framework. Should the Federal Reserve expand the scope of recovery planning expectations to encompass additional firms, this rating will reflect such expectations for the broader set of firms.

    5 The evaluation of the effectiveness of management of business lines would include management of critical operations.

    6 There are eight domestic firms in the LISCC portfolio: (1) Bank of America Corporation; (2) Bank of New York Mellon Corporation; (3) Citigroup, Inc.; (4) Goldman Sachs Group, Inc.; (5) JP Morgan Chase & Co.; (6) Morgan Stanley; (7) State Street Corporation; and (8) Wells Fargo & Company. In this guidance, these eight firms may collectively be referred to as “domestic LISCC firms.”

    7 “Risk appetite” is defined as the aggregate level and types of risk the board and senior management are willing to assume to achieve the firm's strategic business objectives, consistent with applicable capital, liquidity, and other requirements and constraints.

    B. Assignment of the LFI Component Ratings

    Each LFI component rating is assigned along a four-level scale:

    Broadly Meets Expectations: A firm's practices and capabilities broadly meet supervisory expectations, and the firm possesses sufficient financial and operational strength and resilience to maintain safe-and-sound operations through a range of conditions. The firm may be subject to identified supervisory issues requiring corrective action. These issues are unlikely to present a threat to the firm's ability to maintain safe-and-sound operations through a range of conditions.

    Conditionally Meets Expectations: Certain, material financial or operational weaknesses in a firm's practices or capabilities may place the firm's prospects for remaining safe and sound through a range of conditions at risk if not resolved in a timely manner during the normal course of business.

    The Federal Reserve does not intend for a firm to be assigned a “Conditionally Meets Expectations” rating for a prolonged period, and will work with the firm to develop an appropriate timeframe to fully resolve the issues leading to the rating assignment and merit upgrade to a “Broadly Meets Expectations” rating.

    A firm is assigned a “Conditionally Meets Expectations” rating—as opposed to a “Deficient” rating—when it has the ability to resolve these issues through measures that do not require a material change to the firm's business model or financial profile, or its governance, risk management or internal control structures or practices. Failure to resolve the issues in a timely manner would most likely result in the firm's downgrade to a “Deficient” rating, since the inability to resolve the issues would indicate that the firm does not possess sufficient financial or operational capabilities to maintain its safety and soundness through a range of conditions.

    It is recognized that completion and validation of remediation activities for select supervisory issues—such as those involving information technology modifications—may require an extended time horizon. In all instances, appropriate and effective risk mitigation techniques must be utilized in the interim to maintain safe-and-sound operations under a range of conditions until remediation activities are completed, validated, and fully operational.

    Deficient-1: Financial or operational deficiencies in a firm's practices or capabilities put the firm's prospects for remaining safe and sound through a range of conditions at significant risk. The firm is unable to remediate these deficiencies in the normal course of business, and remediation would typically require the firm to make a material change to its business model or financial profile, or its practices or capabilities.

    A firm's failure to resolve the issues in a timely manner that gave rise to a “Conditionally Meets Expectations” rating would most likely result in its downgrade to a “Deficient” rating.

    A firm with a “Deficient-1” rating is required to take timely corrective action to correct financial or operational deficiencies and to restore and maintain its safety and soundness and compliance with laws and regulations, including those related to consumer protection. There is a strong presumption that a firm with a “Deficient-1” rating will be subject to an informal or formal enforcement action, and this rating assignment could be a barrier for a firm seeking Federal Reserve approval to engage in new or expansionary activities.

    Deficient-2: Financial or operational deficiencies in a firm's practices or capabilities present a threat to the firm's safety and soundness, or have already put the firm in an unsafe and unsound condition.

    A firm with a “Deficient-2” rating is required to immediately implement comprehensive corrective measures, and demonstrate the sufficiency of contingency planning in the event of further deterioration. There is a strong presumption that a firm with a “Deficient-2” rating will be subject to a formal enforcement action, and the Federal Reserve would be unlikely to approve any proposal from a firm with this rating to engage in new or expansionary activities.

    The Federal Reserve will take into account a number of individual elements of a firm's practices, capabilities and performance when making each component rating assignment. The weighting of an individual element in assigning a component rating will depend on its impact on the firm's safety, soundness and resilience as provided for in the LFI rating system definitions. For example, for purposes of the Governance and Controls rating, a limited number of significant deficiencies—or even just one significant deficiency—noted for management of a single material business line could be viewed as sufficiently important to warrant a “Deficient-1” for the Governance and Controls component rating, even if the firm meets supervisory expectations under the Governance and Controls component in all other respects.

    Under the LFI rating system, a firm must be rated “Broadly Meets Expectations” or “Conditionally Meets Expectations” for each of the three component ratings (Capital, Liquidity, Governance and Controls) to be considered “well managed” in accordance with various statutes and regulations.8 A “well managed” firm has sufficient financial and operational strength and resilience to maintain safe-and-sound operations through a range of conditions, including stressful ones.

    8 12 U.S.C. 1841 et seq. and 12 U.S.C. 1461 et seq. See, e.g., 12 CFR 225.4(b)(6), 225.14, 225.22(a), 225.23, 225.85, and 225.86; 12 CFR 211.9(b), 211.10(a)(14), and 211.34; and 12 CFR 223.41.

    C. LFI Rating Components

    The LFI rating system is comprised of three component ratings: 9

    9 There may be instances where deficiencies or supervisory issues may be relevant to the Federal Reserve's assessment of more than one component area. As such, the LFI rating will reflect these deficiencies or issues within multiple rating components when necessary to provide a comprehensive supervisory assessment.

    1. Capital Planning and Positions Component Rating

    The Capital Planning and Positions component rating evaluates (i) the effectiveness of a firm's governance and planning processes used to determine the amount of capital necessary to cover risks and exposures, and to support activities through a range of conditions; and (ii) the sufficiency of a firm's capital positions to comply with applicable regulatory requirements and to support the firm's ability to continue to serve as a financial intermediary through a range of conditions.

    In developing this rating, the Federal Reserve evaluates:

    Capital Planning: The extent to which a firm maintains sound capital planning practices through effective governance and oversight; effective risk management and controls; maintenance of updated capital policies and contingency plans for addressing potential shortfalls; and incorporation of appropriately stressful conditions into capital planning and projections of capital positions; and

    Capital Positions: The extent to which a firm's capital is sufficient to comply with regulatory requirements, and to support its ability to meet its obligations to depositors, creditors, and other counterparties and continue to serve as a financial intermediary through a range of conditions.

    Definitions for the Capital Planning and Positions Component Rating Broadly Meets Expectations

    A firm's capital planning and positions broadly meet supervisory expectations and support maintenance of safe-and-sound operations. Specifically:

    • The firm is capable of producing sound assessments of capital adequacy through a range of conditions; and

    • The firm's current and projected capital positions comply with regulatory requirements, and support its ability to absorb current and potential losses, to meet obligations, and to continue to serve as a financial intermediary through a range of conditions.

    A firm rated “Broadly Meets Expectations” may be subject to identified supervisory issues requiring corrective action. However, these issues are unlikely to present a threat to the firm's ability to maintain safe-and-sound operations through a range of potentially stressful conditions.

    A firm that does not meet the capital planning and position expectations associated with a “Broadly Meets Expectations” rating will be rated “Conditionally Meets Expectations,” “Deficient-1,” or “Deficient-2,” and subject to potential consequences as outlined below.

    Conditionally Meets Expectations

    Certain, material financial or operational weaknesses in a firm's capital planning or positions may place the firm's prospects for remaining safe and sound through a range of conditions at risk if not resolved in a timely manner during the normal course of business.

    Specifically, if left unresolved, these weaknesses:

    • May threaten the firm's ability to produce sound assessments of capital adequacy through a range of conditions; and/or

    • May result in the firm's projected capital positions being insufficient to absorb potential losses, comply with regulatory requirements, and support the firm's ability to meet current and prospective obligations and to continue to serve as a financial intermediary through a range of conditions.

    The Federal Reserve does not intend for a firm to be rated “Conditionally Meets Expectations” for a prolonged period. The firm has the ability to resolve these issues through measures that do not require a material change to the firm's business model or financial profile, or its governance, risk management, or internal control structures or practices. The Federal Reserve will work with the firm to develop an appropriate timeframe during which the firm would be required to resolve each supervisory issue leading to the “Conditionally Meets Expectations” rating.

    The Federal Reserve will closely monitor the firm's remediation and mitigation activities; in most instances, the firm will either:

    (i) Resolve the issues in a timely manner and, if no new material supervisory issues arise, be upgraded to a “Broadly Meets Expectations” rating because the firm's capital planning practices and related positions would broadly meet supervisory expectations; or

    (ii) Fail to resolve the issues in a timely manner and be downgraded to a “Deficient-1” rating, because the inability to resolve the issues would indicate that the firm does not possess sufficient financial or operational capabilities to maintain its safety and soundness through a range of conditions.

    It is possible that a firm may be close to completing resolution of the supervisory issues leading to the “Conditionally Meets Expectations” rating, but new issues are identified that, taken alone, would be consistent with a “Conditionally Meets Expectations” rating. In this event, the firm may continue to be rated “Conditionally Meets Expectations,” provided the new issues do not reflect a pattern of deeper or prolonged capital planning or position weaknesses consistent with a “Deficient” rating.

    A “Conditionally Meets Expectations” rating may be assigned to a firm that meets the above definition regardless of its prior rating. A firm previously rated “Deficient-1” may be upgraded to “Conditionally Meets Expectations” if the firm's remediation and mitigation activities are sufficiently advanced so that the firm's prospects for remaining safe and sound are no longer at significant risk, even if the firm has outstanding supervisory issues or is subject to an active enforcement action.

    Deficient-1

    Financial or operational deficiencies in a firm's capital planning or positions put the firm's prospects for remaining safe and sound through a range of conditions at significant risk. The firm is unable to remediate these deficiencies in the normal course of business, and remediation would typically require a material change to the firm's business model or financial profile, or its capital planning practices.

    Specifically, although the firm's current condition is not considered to be materially threatened:

    • Deficiencies in the firm's capital planning processes are not effectively mitigated. These deficiencies limit the firm's ability to effectively assess capital adequacy through a range of conditions; and/or

    • The firm's projected capital positions may be insufficient to absorb potential losses and to support its ability to meet current and prospective obligations and serve as a financial intermediary through a range of conditions.

    Supervisory issues that place the firm's safety and soundness at significant risk, and where resolution is likely to require steps that clearly go beyond the normal course of business—such as issues requiring a material change to the firm's business model or financial profile, or its governance, risk management or internal control structures or practices—would generally warrant assignment of a “Deficient-1” rating.

    A “Deficient-1” rating may be assigned to a firm regardless of its prior rating. A firm previously rated “Broadly Meets Expectations” may be downgraded to “Deficient-1” when supervisory issues are identified that place the firm's prospects for maintaining safe-and-sound operations through a range of potentially stressful conditions at significant risk. A firm previously rated “Conditionally Meets Expectations” may be downgraded to “Deficient-1” when the firm's inability to resolve supervisory issues in a timely manner indicates that the firm does not possess sufficient financial or operational capabilities to maintain its safety and soundness through a range of conditions.

    To address these financial or operational deficiencies, the firm is required to take timely corrective action to restore and maintain its capital planning and positions consistent with supervisory expectations. There is a strong presumption that a firm rated “Deficient-1” will be subject to an informal or formal enforcement action by the Federal Reserve.

    A firm rated “Deficient-1” for any rating component would not be considered “well managed,” which would subject the firm to various consequences. A “Deficient-1” rating could be a barrier for a firm seeking Federal Reserve approval of a proposal to engage in new or expansionary activities, unless the firm can demonstrate that (i) it is making meaningful, sustained progress in resolving identified deficiencies and issues; (ii) the proposed new or expansionary activities would not present a risk of exacerbating current deficiencies or issues or lead to new concerns; and (iii) the proposed activities would not distract the firm from remediating current deficiencies or issues.

    Deficient-2

    Financial or operational deficiencies in a firm's capital planning or positions present a threat to the firm's safety and soundness, or have already put the firm in an unsafe and unsound condition.

    Specifically, as a result of these deficiencies:

    • The firm's capital planning processes are insufficient to effectively assess the firm's capital adequacy through a range of conditions; and/or

    • The firm's current or projected capital positions are insufficient to absorb current or potential losses, and to support the firm's ability to meet current and prospective obligations and serve as a financial intermediary through a range of conditions.

    To address these deficiencies, the firm is required to immediately (i) implement comprehensive corrective measures sufficient to restore and maintain appropriate capital planning capabilities and adequate capital positions; and (ii) demonstrate the sufficiency, credibility and readiness of contingency planning in the event of further deterioration of the firm's financial or operational strength or resiliency. There is a strong presumption that a firm rated “Deficient-2” will be subject to a formal enforcement action by the Federal Reserve.

    A firm rated “Deficient-2” for any rating component would not be considered “well managed,” which would subject the firm to various consequences. The Federal Reserve would be unlikely to approve any proposal from a firm rated “Deficient-2” to engage in new or expansionary activities.

    2. Liquidity Risk Management and Positions Component Rating

    The Liquidity Risk Management and Positions component rating evaluates (i) the effectiveness of a firm's governance and risk management processes used to determine the amount of liquidity necessary to cover risks and exposures, and to support activities through a range of conditions; and (ii) the sufficiency of a firm's liquidity positions to comply with applicable regulatory requirements and to support the firm's ongoing obligations through a range of conditions.

    In developing this rating, the Federal Reserve evaluates:

    Liquidity Risk Management: The extent to which a firm maintains sound liquidity risk management practices through effective governance and oversight; effective risk management and controls; maintenance of updated liquidity policies and contingency plans for addressing potential shortfalls; and incorporation of appropriately stressful conditions into liquidity planning and projections of liquidity positions; and

    Liquidity Positions: The extent to which a firm's liquidity is sufficient to comply with regulatory requirements, and to support its ability to meet current and prospective obligations to depositors, creditors and other counterparties through a range of conditions.

    Definitions for the Liquidity Risk Management and Positions Component Rating Broadly Meets Expectations

    A firm's liquidity risk management and positions broadly meet supervisory expectations and support maintenance of safe-and-sound operations. Specifically:

    • The firm is capable of producing sound assessments of liquidity adequacy through a range of conditions; and

    • The firm's current and projected liquidity positions comply with regulatory requirements, and support its ability to meet current and prospective obligations and to continue to serve as a financial intermediary through a range of conditions.

    A firm rated “Broadly Meets Expectations” may be subject to identified supervisory issues requiring corrective action. However, these issues are unlikely to present a threat to the firm's ability to maintain safe-and-sound operations through a range of potentially stressful conditions.

    A firm that does not meet the liquidity risk management and position expectations associated with a “Broadly Meets Expectations” rating will be rated “Conditionally Meets Expectations,” “Deficient-1,” or “Deficient-2,” and subject to potential consequences as outlined below.

    Conditionally Meets Expectations

    Certain, material financial or operational weaknesses in a firm's liquidity risk management or positions may place the firm's prospects for remaining safe and sound through a range of conditions at risk if not resolved in a timely manner during the normal course of business.

    Specifically, if left unresolved, these weaknesses:

    • May threaten the firm's ability to produce sound assessments of liquidity adequacy through a range of conditions; and/or

    • May result in the firm's projected liquidity positions being insufficient to comply with regulatory requirements, and support its ability to meet current and prospective obligations and to continue to serve as a financial intermediary through a range of conditions.

    The Federal Reserve does not intend for a firm to be rated “Conditionally Meets Expectations” for a prolonged period. The firm has the ability to resolve these issues through measures that do not require a material change to the firm's business model or financial profile, or its governance, risk management or internal control structures or practices. The Federal Reserve will work with the firm to develop an appropriate timeframe during which the firm would be required to resolve each supervisory issue leading to the “Conditionally Meets Expectations” rating.

    The Federal Reserve will closely monitor the firm's remediation and mitigation activities; in most instances, the firm will either:

    (i) Resolve the issues in a timely manner and, if no new material supervisory issues arise, and be upgraded to a “Broadly Meets Expectations” rating because the firm's liquidity risk management practices and related positions would broadly meet supervisory expectations; or

    (ii) Fail to resolve the issues in a timely manner and be downgraded to a “Deficient-1” rating, because the firm's inability to resolve those issues would indicate that the firm does not possess sufficient financial or operational capabilities to maintain its safety and soundness through a range of conditions.

    It is possible that a firm may be close to completing resolution of the supervisory issues leading to the “Conditionally Meets Expectations” rating, but new issues are identified that, taken alone, would be consistent with a “Conditionally Meets Expectations” rating. In this event, the firm may continue to be rated “Conditionally Meets Expectations,” provided the new issues do not reflect a pattern of deeper or prolonged capital planning or position weaknesses consistent with a “Deficient” rating.

    A “Conditionally Meets Expectations” rating may be assigned to a firm that meets the above definition regardless of its prior rating. A firm previously rated “Deficient-1” may be upgraded to “Conditionally Meets Expectations” if the firm's remediation and mitigation activities are sufficiently advanced so that the firm's prospects for remaining safe and sound are no longer at significant risk, even if the firm has outstanding supervisory issues or is subject to an active enforcement action.

    Deficient-1

    Financial or operational deficiencies in a firm's liquidity risk management or positions put the firm's prospects for remaining safe and sound through a range of conditions at significant risk. The firm is unable to remediate these deficiencies in the normal course of business, and remediation would typically require a material change to the firm's business model or financial profile, or its liquidity risk management practices.

    Specifically, although the firm's current condition is not considered to be materially threatened:

    • Deficiencies in the firm's liquidity risk management processes are not effectively mitigated. These deficiencies limit the firm's ability to effectively assess liquidity adequacy through a range of conditions; and/or

    • The firm's projected liquidity positions may be insufficient to support its ability to meet prospective obligations and serve as a financial intermediary through a range of conditions.

    Supervisory issues that place the firm's safety and soundness at significant risk, and where resolution is likely to require steps that clearly go beyond the normal course of business—such as issues requiring a material change to the firm's business model or financial profile, or its governance, risk management or internal control structures or practices—would generally warrant assignment of a “Deficient-1” rating.

    A “Deficient-1” rating may be assigned to a firm regardless of its prior rating. A firm previously rated “Broadly Meets Expectations” may be downgraded to “Deficient-1” when supervisory issues are identified that place the firm's prospects for maintaining safe-and-sound operations through a range of potentially stressful conditions at significant risk. A firm previously rated “Conditionally Meets Expectations” may be downgraded to “Deficient-1” when the firm's inability to resolve supervisory issues in a timely manner indicates that the firm does not possess sufficient financial or operational capabilities to maintain its safety and soundness through a range of conditions.

    To address these financial or operational deficiencies, the firm is required to take timely corrective action to restore and maintain its liquidity risk management and positions consistent with supervisory expectations. There is a strong presumption that a firm rated “Deficient-1” will be subject to an informal or formal enforcement action by the Federal Reserve.

    A firm rated “Deficient-1” for any rating component would not be considered “well managed,” which would subject the firm to various consequences. A “Deficient-1” rating could be a barrier for a firm seeking Federal Reserve approval of a proposal to engage in new or expansionary activities, unless the firm can demonstrate that (i) it is making meaningful, sustained progress in resolving identified deficiencies and issues; (ii) the proposed new or expansionary activities would not present a risk of exacerbating current deficiencies or issues or lead to new concerns; and (iii) the proposed activities would not distract the firm from remediating current deficiencies or issues.

    Deficient-2

    Financial or operational deficiencies in a firm's liquidity risk management or positions present a threat to the firm's safety and soundness, or have already put the firm in an unsafe and unsound condition.

    Specifically, as a result of these deficiencies:

    • The firm's liquidity risk management processes are insufficient to effectively assess the firm's liquidity adequacy through a range of conditions; and/or

    • The firm's current or projected liquidity positions are insufficient to support the firm's ability to meet current and prospective obligations and serve as a financial intermediary through a range of conditions.

    To address these deficiencies, the firm is required to immediately (i) implement comprehensive corrective measures sufficient to restore and maintain appropriate liquidity risk management capabilities and adequate liquidity positions; and (ii) demonstrate the sufficiency, credibility and readiness of contingency planning in the event of further deterioration of the firm's financial or operational strength or resiliency. There is a strong presumption that a firm rated “Deficient-2” will be subject to a formal enforcement action by the Federal Reserve.

    A firm rated “Deficient-2” for any rating component would not be considered “well managed,” which would subject the firm to various consequences. The Federal Reserve would be unlikely to approve any proposal from a firm rated “Deficient-2” to engage in new or expansionary activities.

    3. Governance and Controls Component Rating

    The Governance and Controls component rating evaluates the effectiveness of a firm's (i) board of directors, (ii) management of business lines and independent risk management and controls, and (iii) recovery planning (for domestic LISCC firms only). This rating assesses a firm's effectiveness in aligning strategic business objectives with the firm's risk appetite and risk management capabilities; maintaining effective and independent risk management and control functions, including internal audit; promoting compliance with laws and regulations, including those related to consumer protection; and otherwise providing for the ongoing resiliency of the firm.

    In developing this rating, the Federal Reserve evaluates:

    Effectiveness of the Board of Directors: The extent to which the board exhibits attributes that are consistent with those of effective boards in carrying out its core roles and responsibilities, including: (i) Setting a clear, aligned, and consistent direction regarding the firm's strategy and risk appetite; (ii) directing senior management regarding the board's information; (iii) overseeing and holding senior management accountable, (iv) supporting the independence and stature of independent risk management and internal audit; and (v) maintaining a capable board composition and governance structure.

    Management of Business Lines and Independent Risk Management and Controls

    The extent to which:

    ○ Senior management effectively and prudently manages the day-to-day operations of the firm and provides for ongoing resiliency; implements the firm's strategy and risk appetite; maintains an effective risk management framework and system of internal controls; and promotes prudent risk taking behaviors and business practices, including compliance with laws and regulations, including those related to consumer protection.

    ○ Business line management executes business line activities consistent with the firm's strategy and risk appetite; identifies and manages risks; and ensures an effective system of internal controls for its operations.

    ○ Independent risk management effectively evaluates whether the firm's risk appetite appropriately captures material risks and is consistent with the firm's risk management capacity; establishes and monitors risk limits that are consistent with the firm's risk appetite; identifies and measures the firm's risks; and aggregates, assesses and reports on the firm's risk profile and positions. Additionally, the firm demonstrates that its internal controls are appropriate and tested for effectiveness. Finally, internal audit effectively and independently assesses the firm's risk management framework and internal control systems, and reports findings to senior management and the firm's audit committee.

    Recovery Planning (domestic LISCC firms only): The extent to which recovery planning processes effectively identify options that provide a reasonable chance of a firm being able to remedy financial weakness and restore market confidence without extraordinary official sector support.

    Definitions for the Governance and Controls Component Rating Broadly Meets Expectations

    A firm's governance and controls broadly meet supervisory expectations and support maintenance of safe-and-sound operations.

    Specifically, the firm's practices and capabilities are sufficient to align strategic business objectives with its risk appetite and risk management capabilities,10 maintain effective and independent risk management and control functions, including internal audit; promote compliance with laws and regulations (including those related to consumer protection); and otherwise provide for the firm's ongoing financial and operational resiliency through a range of conditions.

    10 References to risk management capabilities includes risk management of business lines and independent risk management and control functions, including internal audit.

    A firm rated “Broadly Meets Expectations” may be subject to identified supervisory issues requiring corrective action. However, these issues are unlikely to present a threat to the firm's ability to maintain safe-and-sound operations through a range of potentially stressful conditions.

    A firm that does not meet supervisory expectations associated with a “Broadly Meets Expectations” rating will be rated “Conditionally Meets Expectations,” “Deficient-1,” or “Deficient-2,” and subject to potential consequences, as outlined below.

    Conditionally Meets Expectations

    Certain, material financial or operational weaknesses in a firm's governance and controls practices may place the firm's prospects for remaining safe and sound through a range of conditions at risk if not resolved in a timely manner during the normal course of business.

    Specifically, if left unresolved, these weaknesses may threaten the firm's ability to align strategic business objectives with the firm's risk appetite and risk management capabilities; maintain effective and independent risk management and control functions, including internal audit; promote compliance with laws and regulations (including those related to consumer protection); or otherwise provide for the firm's ongoing resiliency through a range of conditions.

    The Federal Reserve does not intend for a firm to be rated “Conditionally Meets Expectations” for a prolonged period. The firm has the ability to resolve these issues through measures that do not require a material change to the firm's business model or financial profile, or its governance, risk management or internal control structures or practices. The Federal Reserve will work with the firm to develop an appropriate timeframe during which the firm would be required to resolve each supervisory issue leading to the “Conditionally Meets Expectations” rating.

    The Federal Reserve will closely monitor the firm's remediation and mitigation activities; in most instances, the firm will either:

    (i) Resolve the issues in a timely manner and, if no new material supervisory issues arise, and be upgraded to a “Broadly Meets Expectations” rating because the firm's governance and controls would broadly meet supervisory expectations; or

    (ii) Fail to resolve the issues in a timely manner and be downgraded to a “Deficient-1” rating, because the firm's inability to resolve those issues would indicate that the firm does not possess sufficient financial or operational capabilities to maintain its safety and soundness through a range of conditions.

    It is possible that a firm may be close to completing resolution of the supervisory issues leading to the “Conditionally Meets Expectations” rating, but new issues are identified that, taken alone, would be consistent with a “Conditionally Meets Expectations” rating. In this event, the firm may continue to be rated “Conditionally Meets Expectations,” provided the new issues do not reflect a pattern of deeper or prolonged capital planning or position weaknesses consistent with a “Deficient” rating.

    A “Conditionally Meets Expectations” rating may be assigned to a firm that meets the above definition regardless of its prior rating. A firm previously rated “Deficient” may be upgraded to “Conditionally Meets Expectations” if the firm's remediation and mitigation activities are sufficiently advanced so that the firm's prospects for remaining safe and sound are no longer at significant risk, even if the firm has outstanding supervisory issues or is subject to an active enforcement action.

    Deficient-1

    Financial or operational deficiencies in a firm's governance and controls put the firm's prospects for remaining safe and sound through a range of conditions at significant risk. The firm is unable to remediate these deficiencies in the normal course of business, and remediation would typically require a material change to the firm's business model or financial profile, or its governance, risk management or internal control structures or practices.

    Specifically, although the firm's current condition is not considered to be materially threatened, these deficiencies limit the firm's ability to align strategic business objectives with its risk appetite and risk management capabilities; maintain effective and independent risk management and control functions, including internal audit; promote compliance with laws and regulations (including those related to consumer protection); or otherwise provide for the firm's ongoing resiliency through a range of conditions.

    A “Deficient-1” rating may be assigned to a firm regardless of its prior rating. A firm previously rated “Broadly Meets Expectations” may be downgraded to “Deficient-1” when supervisory issues are identified that place the firm's prospects for maintaining safe-and-sound operations through a range of potentially stressful conditions at significant risk. A firm previously rated “Conditionally Meets Expectations” may be downgraded to “Deficient-1” when the firm's inability to resolve supervisory issues in a timely manner indicates that the firm does not possess sufficient financial or operational capabilities to maintain its safety and soundness through a range of conditions.

    To address these financial or operational deficiencies, the firm is required to take timely corrective action to restore and maintain its governance and controls consistent with supervisory expectations. There is a strong presumption that a firm rated “Deficient-1” will be subject to an informal or formal enforcement action by the Federal Reserve.

    A firm rated “Deficient-1” for any rating component would not be considered “well managed,” which would subject the firm to various consequences. A “Deficient-1” rating could be a barrier for a firm seeking Federal Reserve approval of a proposal to engage in new or expansionary activities, unless the firm can demonstrate that (i) it is making meaningful, sustained progress in resolving identified deficiencies and issues; (ii) the proposed new or expansionary activities would not present a risk of exacerbating current deficiencies or issues or lead to new concerns; and (iii) the proposed activities would not distract the firm from remediating current deficiencies or issues.

    Deficient-2

    Financial or operational deficiencies in governance or controls present a threat to the firm's safety and soundness, or have already put the firm in an unsafe and unsound condition. Specifically, as a result of these deficiencies, the firm is unable to align strategic business objectives with its risk appetite and risk management capabilities; maintain effective and independent risk management and control functions, including internal audit; promote compliance with laws and regulations (including those related to consumer protection); or otherwise provide for the firm's ongoing resiliency.

    To address these deficiencies, the firm is required to immediately (i) implement comprehensive corrective measures sufficient to restore and maintain appropriate governance and control capabilities; and (ii) demonstrate the sufficiency, credibility, and readiness of contingency planning in the event of further deterioration of the firm's financial or operational strength or resiliency. There is a strong presumption that a firm rated “Deficient-2” will be subject to a formal enforcement action by the Federal Reserve.

    A firm rated “Deficient-2” for any rating component would not be considered “well managed,” which would subject the firm to various consequences. The Federal Reserve would be unlikely to approve any proposal from a firm rated “Deficient-2” to engage in new or expansionary activities.

    By order of the Board of Governors of the Federal Reserve System, November 2, 2018. Ann Misback, Secretary of the Board.
    [FR Doc. 2018-25350 Filed 11-19-18; 11:15 am] BILLING CODE P
    DEPARTMENT OF TRANSPORTATION Federal Aviation Administration 14 CFR Part 25 [Docket No. FAA-2018-0782; Special Conditions No. 25-736-SC] Special Conditions: Garmin International, Textron Aviation Inc. Model 560XL; Airplane Electronic-System Security Protection From Unauthorized Internal Access AGENCY:

    Federal Aviation Administration (FAA), DOT.

    ACTION:

    Final special conditions; request for comments.

    SUMMARY:

    These special conditions are issued for the Textron Aviation Inc. (Textron) Model 560XL, formerly known as, prior to July 29, 2015, the Cessna Model 560XL. This airplane, as modified by Garmin International (Garmin), will have a novel or unusual design feature when compared to the state of technology envisioned in the airworthiness standards for transport category airplanes. This design feature is Garmin G5000 avionics that allow internal connection to previously isolated data networks, which are connected to systems that perform functions required for the safe operation of the airplane. The applicable airworthiness regulations do not contain adequate or appropriate safety standards for this design feature. These special conditions contain the additional safety standards that the Administrator considers necessary to establish a level of safety equivalent to that established by the existing airworthiness standards.

    DATES:

    This action is effective on Garmin on November 21, 2018. Send comments on or before January 7, 2019.

    ADDRESSES:

    Send comments identified by docket no. FAA-2018-0782 using any of the following methods:

    Federal eRegulations Portal: Go to http://www.regulations.gov/ and follow the online instructions for sending your comments electronically.

    Mail: Send comments to Docket Operations, M-30, U.S. Department of Transportation (DOT), 1200 New Jersey Avenue SE, Room W12-140, West Building Ground Floor, Washington, DC 20590-0001.

    Hand Delivery or Courier: Take comments to Docket Operations in Room W12-140 of the West Building Ground Floor at 1200 New Jersey Avenue SE, Washington, DC, between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays.

    Fax: Fax comments to Docket Operations at 202-493-2251.

    Privacy: The FAA will post all comments it receives, without change, to http://www.regulations.gov/, including any personal information the commenter provides. Using the search function of the docket website, anyone can find and read the electronic form of all comments received into any FAA docket, including the name of the individual sending the comment (or signing the comment for an association, business, labor union, etc.). DOT's complete Privacy Act Statement can be found in the Federal Register published on April 11, 2000 (65 FR 19477-19478).

    Docket: Background documents or comments received may be read at http://www.regulations.gov/ at any time. Follow the online instructions for accessing the docket or go to Docket Operations in Room W12-140 of the West Building Ground Floor at 1200 New Jersey Avenue SE., Washington, DC, between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays.

    FOR FURTHER INFORMATION CONTACT:

    Varun Khanna, Airplane and Flightcrew Interface Section, AIR-671, Transport Standards Branch, Policy and Innovation Division, Aircraft Certification Service, Federal Aviation Administration, 2200 South 216th Street, Des Moines, Washington 98198; telephone and fax 206-231-3159; email [email protected].

    SUPPLEMENTARY INFORMATION:

    The substance of these special conditions has been published in the Federal Register for public comment in several prior instances with no substantive comments received. The FAA therefore finds it unnecessary to delay the effective date and finds that good cause exists for making these special conditions effective upon publication in the Federal Register.

    Comments Invited

    We invite interested people to take part in this rulemaking by sending written comments, data, or views. The most helpful comments reference a specific portion of the special conditions, explain the reason for any recommended change, and include supporting data.

    We will consider all comments we receive by the closing date for comments. We may change these special conditions based on the comments we receive.

    Background

    On March 21, 2017, Garmin applied for a supplemental type certificate to install Garmin G5000 avionics connected to the aircraft-control domain and airline information-services domain in Textron Model 560XL airplanes. This is a twin-engine, turbofan airplane with seating for 12 passengers and two crew members, and a maximum takeoff weight of 20,200 pounds.

    Type Certification Basis

    Under the provisions of title 14, Code of Federal Regulations (14 CFR) 21.101, Garmin must show that the Textron Model 560XL airplane, as changed, continues to meet the applicable provisions of the regulations listed in Type Certificate No. A22CE, or the applicable regulations in effect on the date of application for the change, except for earlier amendments as agreed upon by the FAA.

    If the Administrator finds that the applicable airworthiness regulations (i.e., 14 CFR part 25) do not contain adequate or appropriate safety standards for the Textron Model 560XL airplane because of a novel or unusual design feature, special conditions are prescribed under the provisions of § 21.16.

    Special conditions are initially applicable to the model for which they are issued. Should the applicant apply for a supplemental type certificate to modify any other model included on the same type certificate to incorporate the same novel or unusual design feature, these special conditions would also apply to the other model under § 21.101.

    In addition to the applicable airworthiness regulations and special conditions, the Textron Model 560XL airplane must comply with the fuel-vent and exhaust-emission requirements of 14 CFR part 34, and the noise-certification requirements of 14 CFR part 36.

    The FAA issues special conditions, as defined in 14 CFR 11.19, in accordance with § 11.38, and they become part of the type certification basis under § 21.101.

    Novel or Unusual Design Features

    The Textron Model 560XL airplane, as modified by Garmin, will incorporate the following novel or unusual design features:

    Garmin G5000 avionics that allow internal connection to previously isolated data networks, which are connected to systems that perform functions required for the safe operation of the airplane.

    Discussion

    The Textron Model 560XL airplane architecture is novel or unusual for commercial transport airplanes because it allows connection to previously isolated data networks connected to systems that perform functions required for the safe operation of the airplane. This data network and design integration creates a potential for unauthorized persons to access the aircraft-control domain and airline information-services domain, and presents security vulnerabilities related to the introduction of computer viruses and worms, user errors, and intentional sabotage of airplane electronic assets (networks, systems, and databases) critical to the safety and maintenance of the airplane.

    The existing regulations and guidance material did not anticipate this type of system architecture or electronic access to airplane systems. Furthermore, 14 CFR regulations and the current system-safety assessment policy and techniques do not address potential security vulnerabilities, which could be exploited by unauthorized access to airplane networks and servers. Therefore, these special conditions ensure that the security of airplane systems and networks is not compromised by unauthorized wired or wireless internal access.

    These special conditions contain the additional safety standards that the Administrator considers necessary to establish a level of safety equivalent to that established by the existing airworthiness standards.

    Applicability

    As discussed above, these special conditions are applicable to the Textron Model 560XL airplane. Should Garmin apply at a later date for a supplemental type certificate to modify any other model included on Type Certificate No. A22CE to incorporate the same novel or unusual design feature, these special conditions would apply to that model as well.

    Conclusion

    This action affects only certain novel or unusual design features on one model of airplane. It is not a rule of general applicability and affects only the applicant who applied to the FAA for approval of the features on the airplane.

    List of Subjects in 14 CFR Part 25

    Aircraft, Aviation safety, Reporting and recordkeeping requirements.

    Authority Citation

    The authority citation for these special conditions is as follows:

    Authority:

    49 U.S.C. 106(f), 106(g), 40113, 44701, 44702, 44704.

    The Special Conditions

    Accordingly, pursuant to the authority delegated to me by the Administrator, the following special conditions are issued as part of the type certification basis for Textron Model 560XL airplanes as modified by Garmin, for airplane electronic-system security protection from unauthorized internal access.

    1. The applicant must ensure that the design provides isolation from, or airplane electronic-system security protection against, access by unauthorized sources internal to the airplane. The design must prevent inadvertent and malicious changes to, and all adverse impacts upon, airplane equipment, systems, networks, or other assets required for safe flight and operations.

    2. The applicant must establish appropriate procedures to allow the operator to ensure that continued airworthiness of the airplane is maintained, including all post-type-certification modifications that may have an impact on the approved electronic-system security safeguards.

    Issued in Des Moines, Washington, on November 15, 2018. Chris R. Parker, Acting Manager, Transport Standards Branch, Policy and Innovation Division, Aircraft Certification Service.
    [FR Doc. 2018-25363 Filed 11-20-18; 8:45 am] BILLING CODE 4910-13-P
    DEPARTMENT OF TRANSPORTATION Federal Aviation Administration 14 CFR Part 25 [Docket No. FAA-2018-0781; Special Conditions No. 25-737-SC] Special Conditions: Garmin International, Textron Aviation Inc. Model 560XL; Airplane Electronic-System Security Protection From Unauthorized External Access AGENCY:

    Federal Aviation Administration (FAA), DOT.

    ACTION:

    Final special conditions; request for comments.

    SUMMARY:

    These special conditions are issued for the Textron Aviation (Textron) Model 560XL, formerly known as, prior to July 29, 2015, the Cessna Model 560XL. This airplane, as modified by Garmin International (Garmin), will have a novel or unusual design feature when compared to the state of technology envisioned in the airworthiness standards for transport category airplanes. This design feature is Garmin G5000 avionics that allow external connection to previously isolated data networks, which are connected to systems that perform functions required for the safe operation of the airplane. This feature creates a potential for unauthorized persons to access the aircraft-control domain and airline information-services domain, and presents security vulnerabilities related to the introduction of computer viruses and worms, user errors, and intentional sabotage of airplane electronic assets (networks, systems, and databases). The applicable airworthiness regulations do not contain adequate or appropriate safety standards for this design feature. These special conditions contain the additional safety standards that the Administrator considers necessary to establish a level of safety equivalent to that established by the existing airworthiness standards.

    DATES:

    This action is effective on Garmin on November 21, 2018. Send comments on or before January 7, 2019.

    ADDRESSES:

    Send comments identified by docket no. FAA-2018-0781 using any of the following methods:

    Federal eRegulations Portal: Go to http://www.regulations.gov/ and follow the online instructions for sending your comments electronically.

    Mail: Send comments to Docket Operations, M-30, U.S. Department of Transportation (DOT), 1200 New Jersey Avenue SE, Room W12-140, West Building Ground Floor, Washington, DC 20590-0001.

    Hand Delivery or Courier: Take comments to Docket Operations in Room W12-140 of the West Building Ground Floor at 1200 New Jersey Avenue SE, Washington, DC, between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays.

    Fax: Fax comments to Docket Operations at 202-493-2251.

    Privacy: The FAA will post all comments it receives, without change, to http://www.regulations.gov/, including any personal information the commenter provides. Using the search function of the docket website, anyone can find and read the electronic form of all comments received into any FAA docket, including the name of the individual sending the comment (or signing the comment for an association, business, labor union, etc.). DOT's complete Privacy Act Statement can be found in the Federal Register published on April 11, 2000 (65 FR 19477-19478).

    Docket: Background documents or comments received may be read at http://www.regulations.gov/ at any time. Follow the online instructions for accessing the docket or go to Docket Operations in Room W12-140 of the West Building Ground Floor at 1200 New Jersey Avenue SE, Washington, DC, between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays.

    FOR FURTHER INFORMATION CONTACT:

    Varun Khanna, Airplane and Flightcrew Interface Section, AIR-671, Transport Standards Branch, Policy and Innovation Division, Aircraft Certification Service, Federal Aviation Administration, 2200 South 216th Street, Des Moines, Washington 98198; telephone and fax 206-231-3159; email [email protected].

    SUPPLEMENTARY INFORMATION:

    The substance of these special conditions has been published in the Federal Register for public comment in several prior instances with no substantive comments received. The FAA therefore finds it unnecessary to delay the effective date and finds that good cause exists for making these special conditions effective upon publication in the Federal Register.

    Comments Invited

    We invite interested people to take part in this rulemaking by sending written comments, data, or views. The most helpful comments reference a specific portion of the special conditions, explain the reason for any recommended change, and include supporting data.

    We will consider all comments we receive by the closing date for comments. We may change these special conditions based on the comments we receive.

    Background

    On March 21, 2017, Garmin applied for a supplemental type certificate to install Garmin G5000 avionics connected to the aircraft-control domain and airline information-services domain in Textron Model 560XL airplanes. This is a twin-engine, turbofan airplane with seating for 12 passengers and two crew members, and a maximum takeoff weight of 20,200 pounds.

    Type Certification Basis

    Under the provisions of title 14, Code of Federal Regulations (14 CFR) 21.101, Garmin must show that the Textron Model 560XL airplane, as changed, continues to meet the applicable provisions of the regulations listed in Type Certificate No. A22CE, or the applicable regulations in effect on the date of application for the change, except for earlier amendments as agreed upon by the FAA.

    If the Administrator finds that the applicable airworthiness regulations (i.e., 14 CFR part 25) do not contain adequate or appropriate safety standards for the Textron Model 560XL airplane because of a novel or unusual design feature, special conditions are prescribed under the provisions of § 21.16.

    Special conditions are initially applicable to the model for which they are issued. Should the applicant apply for a supplemental type certificate to modify any other model included on the same type certificate to incorporate the same novel or unusual design feature, these special conditions would also apply to the other model under § 21.101.

    In addition to the applicable airworthiness regulations and special conditions, the Textron Model 560XL airplane must comply with the fuel-vent and exhaust-emission requirements of 14 CFR part 34, and the noise-certification requirements of 14 CFR part 36.

    The FAA issues special conditions, as defined in 14 CFR 11.19, in accordance with § 11.38, and they become part of the type certification basis under § 21.101.

    Novel or Unusual Design Features

    The Textron Model 560XL airplane, as modified by Garmin, will incorporate the following novel or unusual design features:

    Garmin G5000 avionics that allow external connection to previously isolated data networks, which are connected to systems that perform functions required for the safe operation of the airplane.

    Discussion

    The Textron Model 560XL airplane architecture and network configuration may allow increased connectivity to and access from external network sources and airline operations and maintenance networks to the airplane control domain and airline information services domain. The airplane control domain and airline information-services domain perform functions required for the safe operation and maintenance of the airplane. Previously, these domains had very limited connectivity with external network sources. This data network and design integration creates a potential for unauthorized persons to access the aircraft-control domain and airline information-services domain, and presents security vulnerabilities related to the introduction of computer viruses and worms, user errors, and intentional sabotage of airplane electronic assets (networks, systems, and databases) critical to the safety and maintenance of the airplane.

    The existing regulations and guidance material did not anticipate these types of airplane system architectures. Furthermore, 14 CFR regulations and the current system safety assessment policy and techniques do not address potential security vulnerabilities, which could be exploited by unauthorized access to airplane networks, data buses, and servers. Therefore, these special conditions ensure that the security (i.e., confidentiality, integrity, and availability) of airplane systems is not compromised by unauthorized wired or wireless electronic connections.

    These special conditions contain the additional safety standards that the Administrator considers necessary to establish a level of safety equivalent to that established by the existing airworthiness standards.

    Applicability

    As discussed above, these special conditions are applicable to the Textron Model 560XL airplane. Should Garmin apply at a later date for a supplemental type certificate to modify any other model included on Type Certificate No. A22CE to incorporate the same novel or unusual design feature, these special conditions would apply to that model as well.

    Conclusion

    This action affects only certain novel or unusual design features on one model of airplane. It is not a rule of general applicability and affects only the applicant who applied to the FAA for approval of the features on the airplane.

    List of Subjects in 14 CFR Part 25

    Aircraft, Aviation safety, Reporting and recordkeeping requirements.

    Authority Citation

    The authority citation for these special conditions is as follows:

    Authority:

    49 U.S.C. 106(f), 106(g), 40113, 44701, 44702, 44704.

    The Special Conditions

    Accordingly, pursuant to the authority delegated to me by the Administrator, the following special conditions are issued as part of the type certification basis for Textron Model 560XL airplanes, as modified by Garmin, for airplane electronic-system security protection from unauthorized external access.

    1. The applicant must ensure airplane electronic-system security protection from access by unauthorized sources external to the airplane, including those possibly caused by maintenance activity.

    2. The applicant must ensure that electronic-system security threats are identified and assessed, and that effective electronic-system security protection strategies are implemented to protect the airplane from all adverse impacts on safety, functionality, and continued airworthiness.

    3. The applicant must establish appropriate procedures to allow the operator to ensure that continued airworthiness of the airplane is maintained, including all post-type-certification modifications that may have an impact on the approved electronic-system security safeguards.

    Issued in Des Moines, Washington, on November 15, 2018. Chris R. Parker, Acting Manager, Transport Standards Branch, Policy and Innovation Division, Aircraft Certification Service.
    [FR Doc. 2018-25362 Filed 11-20-18; 8:45 am] BILLING CODE 4910-13-P
    DEPARTMENT OF TRANSPORTATION Federal Aviation Administration 14 CFR Part 71 [Docket No. FAA-2018-0741; Airspace Docket No. 18-ASO-13] RIN 2120-AA66 Amendment of Class D Airspace and Establishment of Class E Airspace; Tyndall AFB, FL AGENCY:

    Federal Aviation Administration (FAA), DOT.

    ACTION:

    Final rule.

    SUMMARY:

    This action establishes Class E surface airspace at Tyndall Air Force Base, (AFB), FL, for the safety of aircraft landing and departing the airport when the air traffic control tower is closed. Also, this action amends Class D airspace by updating the geographic coordinates of this airport, as well as replacing the outdated term “Airport/Facility Directory” with “Chart Supplement”. Controlled airspace is necessary for the safety and management of instrument flight rules (IFR) operations at this airport.

    DATES:

    Effective 0901 UTC, January 3, 2019. The Director of the Federal Register approves this incorporation by reference action under Title 1 Code of Federal Regulations part 51, subject to the annual revision of FAA Order 7400.11 and publication of conforming amendments.

    ADDRESSES:

    FAA Order 7400.11C, Airspace Designations and Reporting Points, and subsequent amendments can be viewed on line at http://www.faa.gov/air_traffic/publications/. For further information, you can contact the Airspace Policy Group, Federal Aviation Administration, 800 Independence Avenue SW, Washington, DC, 20591; telephone: (202) 267-8783. The Order is also available for inspection at the National Archives and Records Administration (NARA). For information on the availability of FAA Order 7400.11C at NARA, call (202) 741-6030, or go to https://www.archives.gov/federal-register/cfr/ibr-locations.html.

    FAA Order 7400.11, Airspace Designations and Reporting Points, is published yearly and effective on September 15.

    FOR FURTHER INFORMATION CONTACT:

    John Fornito, Operations Support Group, Eastern Service Center, Federal Aviation Administration, 1701 Columbia Ave, College Park, GA 30337; telephone (404) 305-6364.

    SUPPLEMENTARY INFORMATION: Authority for This Rulemaking

    The FAA's authority to issue rules regarding aviation safety is found in Title 49 of the United States Code. Subtitle I, Section 106 describes the authority of the FAA Administrator. Subtitle VII, Aviation Programs, describes in more detail the scope of the agency's authority. This rulemaking is promulgated under the authority described in Subtitle VII, Part A, Subpart I, Section 40103. Under that section, the FAA is charged with prescribing regulations to assign the use of airspace necessary to ensure the safety of aircraft and the efficient use of airspace. This regulation is within the scope of that authority as it establishes Class E surface airspace and amends Class D airspace at Tyndall AFB, FL, to support IFR operations at this airport.

    History

    The FAA published a notice of proposed rulemaking in the Federal Register (83 FR 45861, September 11, 2018) for Docket No. FAA-2018-0741 to establish Class E surface airspace and amend Class D airspace at Tyndall AFB, FL, to support IFR operations at this airport.

    Interested parties were invited to participate in this rulemaking effort by submitting written comments on the proposal to the FAA. One comment supporting the action was received. After the comment period closed, two additional comments were received that did not clearly indicate a position in support of the proposal, or in opposition to the proposal.

    Class D and E airspace designations are published in Paragraphs 5000 and 6002, respectively, dated August 13, 2018, and effective September 15, 2018, which is incorporated by reference in 14 CFR part 71.1. The Class D and Class E airspace designations listed in this document will be published subsequently in the Order.

    Availability and Summary of Documents for Incorporation by Reference

    This document amends FAA Order 7400.11C, Airspace Designations and Reporting Points, dated August 13, 2018, and effective September 15, 2018. FAA Order 7400.11C is publicly available as listed in the ADDRESSES section of this document. FAA Order 7400.11C lists Class A, B, C, D, and E airspace areas, air traffic service routes, and reporting points.

    The Rule

    This amendment to Title 14 Code of Federal Regulations (14 CFR) part 71 establishes Class E surface airspace within a 5.4-mile radius of Tyndall AFB, FL, for the safety of aircraft landing and departing the airport when the air traffic control tower is closed.

    In addition, the geographic coordinates of the airport in Class D airspace are updated to coincide with the FAA's database.

    Finally, the outdated term `Airport/Facility Directory' is replaced with `Chart Supplement' under the Class D description.

    These changes are necessary for continued safety and management of IFR operations at this airport.

    Regulatory Notices and Analyses

    The FAA has determined that this regulation only involves an established body of technical regulations for which frequent and routine amendments are necessary to keep them operationally current. It, therefore: (1) Is not a “significant regulatory action” under Executive Order 12866; (2) is not a “significant rule” under DOT Regulatory Policies and Procedures (44 FR 11034; February 26, 1979); and (3) does not warrant preparation of a regulatory evaluation as the anticipated impact is so minimal. Since this is a routine matter that only affects air traffic procedures and air navigation, it is certified that this rule, when promulgated, does not have a significant economic impact on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.

    Environmental Review

    The FAA has determined that this action qualifies for categorical exclusion under the National Environmental Policy Act in accordance with FAA Order 1050.1F, “Environmental Impacts: Policies and Procedures,” paragraph 5-6.5a. This airspace action is not expected to cause any potentially significant environmental impacts, and no extraordinary circumstances exist that warrant preparation of an environmental assessment.

    Lists of Subjects in 14 CFR Part 71

    Airspace, Incorporation by reference, Navigation (air).

    Adoption of the Amendment

    In consideration of the foregoing, the Federal Aviation Administration amends 14 CFR part 71 as follows:

    PART 71—DESIGNATION OF CLASS A, B, C, D, AND E AIRSPACE AREAS; AIR TRAFFIC SERVICE ROUTES; AND REPORTING POINTS 1. The authority citation for part 71 continues to read as follows: Authority:

    49 U.S.C. 106(f), 106(g); 40103, 40113, 40120; E.O. 10854, 24 FR 9565, 3 CFR, 1959-1963 Comp., p. 389.

    § 71.1 [Amended]
    2. The incorporation by reference in 14 CFR 71.1 of FAA Order 7400.11C, Airspace Designations and Reporting Points, dated August 13, 2018, effective September 15, 2018, is amended as follows: Paragraph 5000 Class D Airspace. ASO FL D Tyndall AFB, FL [Amended] Tyndall AFB, FL (Lat. 30°04′09″ N, long. 85°34′30″ W)

    That airspace extending upward from the surface to and including 2,500 feet MSL within a 5.4-mile radius of Tyndall AFB. This Class D airspace area is effective during the specific dates and times established in advance by a Notice to Airmen. The effective date and time will thereafter be continuously published in the Chart Supplement.

    Paragraph 6002 Class E Airspace Areas Designated as Surface Areas. ASO FL E2 Tyndall AFB, FL [New] Tyndall AFB, FL (Lat. 30°04′09″ N, long. 85°34′30″ W)

    That airspace extending upward from the surface within a 5.4-mile radius of Tyndall AFB. This Class E airspace is effective during specific dates and times established in advance by a Notice to Airmen. The effective date and time will thereafter be continuously published in the Chart Supplement.

    Issued in College Park, Georgia, on November 13, 2018. Matthew Cathcart, Acting Manager, Operations Support Group, Eastern Service Center, Air Traffic Organization.
    [FR Doc. 2018-25328 Filed 11-20-18; 8:45 am] BILLING CODE 4910-13-P
    DEPARTMENT OF TRANSPORTATION Federal Aviation Administration 14 CFR Part 71 [Docket No. FAA-2018-0745; Airspace Docket No. 18-ASO-15] RIN 2120-AA66 Amendment of Class E Airspace, Mountain City, TN; and Establishment of Class E Airspace; Elizabethton, TN AGENCY:

    Federal Aviation Administration (FAA), DOT.

    ACTION:

    Final rule.

    SUMMARY:

    This action amends Class E airspace extending upward from 700 feet above the surface in Mountain City, TN, to accommodate new area navigation (RNAV) global positioning system (GPS) standard instrument approach procedures serving Johnson County Airport. In addition, Class E airspace extending upward from 700 feet above the surface is established in Elizabethton, TN, to accommodate area navigation (RNAV) global positioning system (GPS) standard instrument approach procedures at Elizabethton Municipal Airport. Controlled airspace is necessary for the safety and management of instrument flight rules (IFR) operations at these airports.

    DATES:

    Effective 0901 UTC, January 3, 2019. The Director of the Federal Register approves this incorporation by reference action under Title 1 Code of Federal Regulations part 51, subject to the annual revision of FAA Order 7400.11 and publication of conforming amendments.

    ADDRESSES:

    FAA Order 7400.11C, Airspace Designations and Reporting Points, and subsequent amendments can be viewed online at http://www.faa.gov/air_traffic/publications/. For further information, you can contact the Airspace Policy Group, Federal Aviation Administration, 800 Independence Avenue SW, Washington, DC 20591; telephone: (202) 267-8783. The Order is also available for inspection at the National Archives and Records Administration (NARA). For information on the availability of FAA Order 7400.11C at NARA, call (202) 741-6030, or go to https://www.archives.gov/federal-register/cfr/ibr-locations.html.

    FAA Order 7400.11, Airspace Designations and Reporting Points, is published yearly and effective on September 15.

    FOR FURTHER INFORMATION CONTACT:

    John Fornito, Operations Support Group, Eastern Service Center, Federal Aviation Administration, 1701 Columbia Avenue, College Park, GA 30337; telephone (404) 305-6364.

    SUPPLEMENTARY INFORMATION: Authority for This Rulemaking

    The FAA's authority to issue rules regarding aviation safety is found in Title 49 of the United States Code. Subtitle I, Section 106 describes the authority of the FAA Administrator. Subtitle VII, Aviation Programs, describes in more detail the scope of the agency's authority. This rulemaking is promulgated under the authority described in Subtitle VII, Part A, Subpart I, Section 40103. Under that section, the FAA is charged with prescribing regulations to assign the use of airspace necessary to ensure the safety of aircraft and the efficient use of airspace. This regulation is within the scope of that authority as it amends Class E airspace at Johnson County Airport, Mountain City, TN, and establishes Class E airspace at Elizabethton Municipal, Elizabethton, TN, to support IFR operations at these airports.

    History

    The FAA published a notice of proposed rulemaking in the Federal Register (83 FR 47577, September 20, 2018) for Docket No. FAA-2018-0745 to amend Class E airspace at Johnson County Airport, Mountain City, TN, and establish Class E airspace at Elizabethton Municipal, Elizabethton, TN, to support IFR operations at these airports.

    Interested parties were invited to participate in this rulemaking effort by submitting written comments on the proposal to the FAA. No comments were received.

    Class E airspace designations are published in paragraph 6005, of FAA Order 7400.11C dated August 13, 2018, and effective September 15, 2018, which is incorporated by reference in 14 CFR part 71.1. The Class E airspace designation listed in this document will be published subsequently in the Order.

    Availability and Summary of Documents for Incorporation by Reference

    This document amends FAA Order 7400.11C, Airspace Designations and Reporting Points, dated August 13, 2018, and effective September 15, 2018. FAA Order 7400.11C is publicly available as listed in the ADDRESSES section of this document. FAA Order 7400.11C lists Class A, B, C, D, and E airspace areas, air traffic service routes, and reporting points.

    The Rule

    This amendment to Title 14 Code of Federal Regulations (14 CFR) part 71 will amend Class E airspace extending upward from 700 feet or more above the surface at Johnson County Airport, Mountain City, TN, by increasing the northeast extension to 14.4 miles (from 10.9 miles), and creating a 14-mile extension southwest of the airport, to accommodate new area navigation (RNAV) global positioning system (GPS) standard instrument approach procedures at the airport.

    Additionally, Class E airspace extending upward from 700 feet above the surface is established at Elizabethton Municipal Airport, Elizabethton, TN, within a 9.5-mile radius of the airport, and within 4-miles each side of the 243° bearing from the airport, extending from the 9.5-mile radius to 15-miles southwest of the airport to accommodate RNAV (GPS) standard instrument approach procedures for IFR operations at these airports.

    Regulatory Notices and Analyses

    The FAA has determined that this regulation only involves an established body of technical regulations for which frequent and routine amendments are necessary to keep them operationally current. It, therefore: (1) Is not a “significant regulatory action” under Executive Order 12866; (2) is not a “significant rule” under DOT Regulatory Policies and Procedures (44 FR 11034; February 26, 1979); and (3) does not warrant preparation of a regulatory evaluation as the anticipated impact is so minimal. Since this is a routine matter that only affects air traffic procedures and air navigation, it is certified that this rule, when promulgated, does not have a significant economic impact on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.

    Environmental Review

    The FAA has determined that this action qualifies for categorical exclusion under the National Environmental Policy Act in accordance with FAA Order 1050.1F, “Environmental Impacts: Policies and Procedures,” paragraph 5-6.5a. This airspace action is not expected to cause any potentially significant environmental impacts, and no extraordinary circumstances exist that warrant preparation of an environmental assessment.

    Lists of Subjects in 14 CFR Part 71

    Airspace, Incorporation by reference, Navigation (air).

    Adoption of the Amendment

    In consideration of the foregoing, the Federal Aviation Administration amends 14 CFR part 71 as follows:

    PART 71—DESIGNATION OF CLASS A, B, C, D, AND E AIRSPACE AREAS; AIR TRAFFIC SERVICE ROUTES; AND REPORTING POINTS 1. The authority citation for part 71 continues to read as follows: Authority:

    49 U.S.C. 106(f), 106(g); 40103, 40113, 40120; E.O. 10854, 24 FR 9565, 3 CFR, 1959-1963 Comp., p. 389.

    § 71.1 [Amended]
    2. The incorporation by reference in 14 CFR 71.1 of Federal Aviation Administration Order 7400.11C, Airspace Designations and Reporting Points, dated August 13, 2018, and effective September 15, 2018, is amended as follows: Paragraph 6005 Class E Airspace Areas Extending Upward From 700 Feet or More Above the Surface of the Earth. ASO TN E5 Mountain City, TN [Amended] Johnson County Airport, TN (Lat. 36°25′04″ N, long. 81°49′31″ W)

    That airspace extending upward from 700 feet above the surface within a 6.7 -mile radius of the Johnson County Airport, and within 3.2 miles each side of the 066° bearing from the airport, extending from the 6.7-mile radius to 14.4 miles northeast of the airport, and within 3.2 miles each side of the 251° bearing from the airport, extending from the 6.7-mile radius to 14-miles southwest of the airport.

    ASO TN E5 Elizabethton, TN [New] Elizabethton Municipal Airport, TN (Lat. 36°22′16″ N, long. 82°10′24″ W)

    That airspace extending upward from 700 feet above the surface within a 9.5-mile radius of Elizabethton Municipal Airport, and within 4-miles each side of the 243° bearing from the airport, extending from the 9.5-mile radius to 15-miles southwest of the airport.

    Issued in College Park, Georgia, on November 13, 2018. Matthew Cathcart, Acting Manager, Operations Support Group, Eastern Service Center, Air Traffic Organization.
    [FR Doc. 2018-25329 Filed 11-20-18; 8:45 am] BILLING CODE 4910-13-P
    DEPARTMENT OF HOMELAND SECURITY Coast Guard 33 CFR Part 117 [Docket No. USCG-2018-0825] Drawbridge Operation Regulation; Okeechobee Waterway (Caloosahatchee River), LaBelle, FL AGENCY:

    Coast Guard, DHS.

    ACTION:

    Notice of deviation from drawbridge regulation.

    SUMMARY:

    The Coast Guard has issued a temporary deviation from the operating schedule that governs the Caloosahatchee River (SR 29/LaBelle) Bridge across the Okeechobee Waterway (Caloosahatchee River), mile 103, at LaBelle, FL. The deviation is necessary to accommodate repairs to the bridge. This deviation allows the bridge single-leaf openings with advanced notice for a double-leaf opening.

    DATES:

    This deviation is effective without actual notice from November 21, 2018 through 6 a.m. on December 31, 2018. For the purposes of enforcement, actual notice will be used from 6 a.m. on August 13, 2018, until November 21, 2018.

    ADDRESSES:

    The docket for this deviation, USCG-2018-0825 is available at http://www.regulations.gov. Type the docket number in the “SEARCH” box and click “SEARCH”. Click on Open Docket Folder on the line associated with this deviation.

    FOR FURTHER INFORMATION CONTACT:

    If you have questions on this temporary deviation, call or email MST1 Deborah A. Schneller, Coast Guard Sector Saint Petersburg Waterways Management Division; telephone (813) 228-2194 x 8133, email [email protected].

    SUPPLEMENTARY INFORMATION:

    Seacoast Inc., on behalf of the bridge owner, Florida Department of Transportation (FDOT), has requested a temporary deviation from the current operating regulation that governs the Caloosahatchee River (SR29/LaBelle) Bridge across the Okeechobee Waterway (Caloosahatchee River), mile 103, at LaBelle, FL. The deviation is necessary to facilitate necessary repairs to the structural integrity of the bridge. The existing bridge is a double-leaf bascule bridge with at vertical clearance in the closed to navigation position of 28 feet under normal water level conditions on the Okeechobee Waterway.

    The current operating schedule is set out in 33 CFR 117.317(i)(j). Under this temporary deviation, the bridge will provide single-leaf openings utilizing the current operating schedule. Request for a double-leaf opening requires advance notice by contacting the bridge tender at (813) 228-2191 at least four hours in advance. The vertical clearance of the bridge will be reduced to 26 feet under normal water level conditions on the Okeechobee Waterway to allow for post tensioning of the existing steel floor beams. The Okeechobee Waterway (Caloosahatchee River) is used by a variety of vessels including U.S. government vessels, small commercial vessels, recreational vessels and tugs and barge traffic. The Coast Guard has carefully considered the restrictions with waterway users in publishing this temporary deviation.

    Vessels able to pass through the bridge in the closed position may do so at any time. The bridge will not be able to provide a double-leaf opening for emergencies and there is no immediate alternate route for vessels to pass. The Coast Guard will also inform the users of the waterways through our Local and Broadcast Notices to Mariners of the change in operating schedule for the bridge so that vessel operators can arrange their transits to minimize any impact caused by the temporary deviation.

    In accordance with 33 CFR 117.35(e), the drawbridge must return to its regular operating schedule immediately at the end of the effective period of this temporary deviation. This deviation from the operating regulations is authorized under 33 CFR 117.35.

    Dated: November 15, 2018. Barry L. Dragon, Director, Bridge Branch, Seventh Coast Guard District.
    [FR Doc. 2018-25332 Filed 11-20-18; 8:45 am] BILLING CODE 9110-04-P
    DEPARTMENT OF HOMELAND SECURITY Coast Guard 33 CFR Part 165 [Docket Number USCG-2018-0653] RIN 1625-AA00 Safety Zone; Ohio River, Mile 28.0 to 29.2, Vanport, Pennsylvania AGENCY:

    Coast Guard, DHS.

    ACTION:

    Temporary final rule.

    SUMMARY:

    The Coast Guard is establishing a temporary safety zone for all navigable waters of the Ohio River from mile 28.0 to mile 29.2. This action is necessary to protect persons, vessels, and the marine environment from potential hazards associated with power line work across the river. Entry of persons or vessels into this zone is prohibited unless authorized by the Captain of the Port Marine Safety Unit Pittsburgh or a designated representative.

    DATES:

    This rule is effective without actual notice from November 21, 2018 through December 31, 2018. For the purposes of enforcement, actual notice will be used from 6 a.m. on November 16, 2018 through November 21, 2018.

    ADDRESSES:

    To view documents mentioned in this preamble as being available in the docket, go to http://www.regulations.gov, type USCG-2018-0653 in the “SEARCH” box and click “SEARCH.” Click on Open Docket Folder on the line associated with this rule.

    FOR FURTHER INFORMATION CONTACT:

    If you have questions on this rule, call or email Petty Officer Jennifer Haggins, Marine Safety Unit Pittsburgh, U.S. Coast Guard; telephone 412-221-0807, email [email protected].

    SUPPLEMENTARY INFORMATION: I. Table of Abbreviations CFR Code of Federal Regulations COTP Captain of the Port Marine Safety Unit Pittsburgh DHS Department of Homeland Security FR Federal Register NPRM Notice of proposed rulemaking § Section U.S.C. United States Code II. Background Information and Regulatory History

    The Coast Guard is issuing this temporary rule without prior notice and opportunity to comment pursuant to authority under section 4(a) of the Administrative Procedure Act (APA) (5 U.S.C. 553(b)). This provision authorizes an agency to issue a rule without prior notice and opportunity to comment when the agency for good cause finds that those procedures are “impracticable, unnecessary, or contrary to the public interest.” Under 5 U.S.C. 553(b)(3)(B), the Coast Guard finds that good cause exists for not publishing a notice of proposed rulemaking (NPRM) with respect to this rule because it is impracticable. This safety zone must be established by November 16, 2018 and we lack sufficient time to provide a reasonable comment period and then consider those comments before issuing this rule. The NPRM process would delay the establishment of the safety zone until after the date of the power line pulls and compromise public safety.

    Under 5 U.S.C. 553(d)(3), the Coast Guard finds that good cause exists for making this rule effective less than 30 days after publication in the Federal Register. Delaying this rule would be contrary to the public interest because immediate action is necessary to respond to the potential safety hazards associated with power line work, which could pose a risk to the operation and waterways users if the normal vessel traffic were to interfere with the work. Possible hazards include risks of injury or death from near or actual contact among working vessels and mariners traversing through the safety zone.

    III. Legal Authority and Need for Rule

    The Coast Guard is issuing this rule under authority in 33 U.S.C. 1231. The Captain of the Port Marine Safety Unit Pittsburgh (COTP) has determined that potential hazards associated with power line pulls across the Ohio River will be a safety hazard for anyone within a 1.2 mile stretch of the Ohio River. The rule is needed to protect people from power line work which could pose a risk to the operation and waterways users if the normal vessel traffic were to interfere with the work. Possible hazards include risks of injury or death from near or actual contact among working vessels and mariners traversing through the safety zone.

    IV. Discussion of the Rule

    This rule establishes a temporary safety zone from 6 a.m. through 8 p.m. on November 16, 2018 through December 31, 2018. The safety zone will cover all navigable waters of the Ohio River, from mile 28.0 to mile 29.2. The duration of the zone is intended to protect persons, vessels, and the marine environment on these navigable waters before, during, and after the power line pulls. No vessel or person will be permitted to enter the safety zone without obtaining permission from the COTP or a designated representative. A designated representative is a commissioned, warrant, or petty officer of the U.S. Coast Guard assigned to units under the operational control of USCG Marine Safety Unit Pittsburgh. Persons and vessels seeking entry into this safety zone must request permission from the COTP or a designated representative. They may be contacted on VHF-FM Channel 16 or by telephone at (412) 221-0807. Persons and vessels permitted to enter this safety zone must transit at their slowest safe speed and comply with all lawful instructions of the COTP or a designated representative. The COTP or a designated representative will inform the public of the enforcement period for the safety zone as well as any changes in the schedule through Broadcast Notices to Mariners (BNMs), Local Notices to Mariners (LNMs), and/or Marine Safety Information Bulletins (MSIBs) as appropriate.

    V. Regulatory Analyses

    We developed this rule after considering numerous statutes and Executive orders related to rulemaking. Below we summarize our analyses based on a number of these statutes and Executive orders, and we discuss First Amendment rights of protestors.

    A. Regulatory Planning and Review

    Executive Orders 13563 (“Improving Regulation and Regulatory Review”) and 12866 (“Regulatory Planning and Review”) direct agencies to assess the costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, distributive impacts, and equity). Executive Order 13563 emphasizes the importance of quantifying both costs and benefits, of reducing costs, of harmonizing rules, and of promoting flexibility. Executive Order 13771 (“Reducing Regulation and Controlling Regulatory Costs”) directs agencies to reduce regulation and control regulatory costs and provides that “for every one new regulation issued, at least two prior regulations be identified for elimination, and that the cost of planned regulations be prudently managed and controlled through a budgeting process.”

    The Office of Management and Budget (OMB) has not designated this rule a “significant regulatory action,” under section 3(f) of Executive Order 12866. Accordingly, OMB has not reviewed it. As this rule is not a significant regulatory action, this rule is exempt from the requirements of Executive Order 13771. See OMB's Memorandum “Guidance Implementing Executive Order 13771, Titled `Reducing Regulation and Controlling Regulatory Costs'” (April 5, 2017).

    B. Impact on Small Entities

    The Regulatory Flexibility Act of 1980, 5 U.S.C. 601-612, as amended, requires Federal agencies to consider the potential impact of regulations on small entities during rulemaking. The term “small entities” comprises small businesses, not-for-profit organizations that are independently owned and operated and are not dominant in their fields, and governmental jurisdictions with populations of less than 50,000. The Coast Guard certifies under 5 U.S.C. 605(b) that this rule will not have a significant economic impact on a substantial number of small entities.

    While some owners or operators of vessels intending to transit the temporary safety zone may be small entities, for the reasons stated in section V.A above, this rule will not have a significant economic impact on any vessel owner or operator.

    Under section 213(a) of the Small Business Regulatory Enforcement Fairness Act of 1996 (Pub. L. 104-121), we want to assist small entities in understanding this rule. If the rule would affect your small business, organization, or governmental jurisdiction and you have questions concerning its provisions or options for compliance, please contact the person listed in the FOR FURTHER INFORMATION CONTACT section.

    Small businesses may send comments on the actions of Federal employees who enforce, or otherwise determine compliance with, Federal regulations to the Small Business and Agriculture Regulatory Enforcement Ombudsman and the Regional Small Business Regulatory Fairness Boards. The Ombudsman evaluates these actions annually and rates each agency's responsiveness to small business. If you wish to comment on actions by employees of the Coast Guard, call 1-888-REG-FAIR (1-888-734-3247). The Coast Guard will not retaliate against small entities that question or complain about this rule or any policy or action of the Coast Guard.

    C. Collection of Information

    This rule will not call for a new collection of information under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).

    D. Federalism and Indian Tribal Governments

    A rule has implications for federalism under Executive Order 13132, Federalism, if it has a substantial direct effect on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government. We have analyzed this rule under that Order and have determined that it is consistent with the fundamental federalism principles and preemption requirements described in Executive Order 13132.

    Also, this rule does not have tribal implications under Executive Order 13175, Consultation and Coordination with Indian Tribal Governments, because it does not have a substantial direct effect on one or more Indian tribes, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes. If you believe this rule has implications for federalism or Indian tribes, please contact the person listed in the FOR FURTHER INFORMATION CONTACT section above.

    E. Unfunded Mandates Reform Act

    The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538) requires Federal agencies to assess the effects of their discretionary regulatory actions. In particular, the Act addresses actions that may result in the expenditure by a State, local, or tribal government, in the aggregate, or by the private sector of $100,000,000 (adjusted for inflation) or more in any one year. Though this rule will not result in such an expenditure, we do discuss the effects of this rule elsewhere in this preamble.

    F. Environment

    We have analyzed this rule under Department of Homeland Security Directive 023-01 and Commandant Instruction M16475.1D, which guide the Coast Guard in complying with the National Environmental Policy Act of 1969 (42 U.S.C. 4321-4370f), and have determined that this action is one of a category of actions that do not individually or cumulatively have a significant effect on the human environment. This rule involves a safety zone lasting 13 hours on each day that will prohibit entry on a 1.2 mile stretch of the Ohio River. It is categorically excluded from further review under paragraph L60(a) of Appendix A, Table 1 of DHS Instruction Manual 023-01-001-01, Rev. 01. A Record of Environmental Consideration supporting this determination is available in the docket where indicated under ADDRESSES.

    G. Protest Activities

    The Coast Guard respects the First Amendment rights of protesters. Protesters are asked to contact the person listed in the FOR FURTHER INFORMATION CONTACT section to coordinate protest activities so that your message can be received without jeopardizing the safety or security of people, places or vessels.

    List of Subjects in 33 CFR Part 165

    Harbors, Marine safety, Navigation (water), Reporting and recordkeeping requirements, Security measures, Waterways.

    For the reasons discussed in the preamble, the Coast Guard amends 33 CFR part 165 as follows:

    PART 165—REGULATED NAVIGATION AREAS AND LIMITED ACCESS AREAS 1. The authority citation for part 165 continues to read as follows: Authority:

    33 U.S.C. 1231; 50 U.S.C. 191; 33 CFR 1.05-1, 6.04-1, 6.04-6, and 160.5; Department of Homeland Security Delegation No. 0170.1.

    2. Add § 165.T08-0653 to read as follows:
    § 165.T08-0653 Safety Zone; Ohio River, mile 28.0 to mile 29.2, Vanport, PA.

    (a) Location. The following area is a safety zone: All navigable waters of the Ohio River from mile 28.0 to mile 29.2.

    (b) Effective period. This section is effective without actual notice from November 21, 2018 through December 31, 2018. For the purposes of enforcement, actual notice will be used from 6 a.m. on November 16, 2018 through November 21, 2018.

    (c) Enforcement periods. This section will be enforced from 6 a.m. through 8 p.m. daily. Breaks in the power line work will occur during the enforcement periods, which will allow for vessels to pass through the safety zone. The Captain of the Port Marine Safety Unit Pittsburgh (COTP) or a designated representative will provide notice of breaks as appropriate under paragraph (e) of this section.

    (d) Regulations. (1) In accordance with the general regulations in § 165.23, entry into this zone is prohibited unless authorized by the COTP or a designated representative. A designated representative is a commissioned, warrant, or petty officer of the U.S. Coast Guard assigned to units under the operational control of USCG Marine Safety Unit Pittsburgh.

    (2) Persons and vessels seeking entry into this safety zone must request permission from the COTP or a designated representative. They may be contacted on VHF-FM Channel 16 or by telephone at (412) 221-0807.

    (3) Persons and vessels permitted to enter this safety zone must transit at their slowest safe speed and comply with all lawful instructions of the COTP or a designated representative.

    (e) Informational broadcasts. The COTP or a designated representative will inform the public of the enforcement period for the safety zone as well as any changes in the schedule through Broadcast Notices to Mariners (BNMs), Local Notices to Mariners (LNMs), and/or Marine Safety Information Bulletins (MSIBs) as appropriate.

    Dated: November 16, 2018. A.W. Demo, Commander, U.S. Coast Guard, Captain of the Port Marine Safety Unit Pittsburgh.
    [FR Doc. 2018-25379 Filed 11-20-18; 8:45 am] BILLING CODE 9110-04-P
    DEPARTMENT OF THE INTERIOR Fish and Wildlife Service 50 CFR Part 17 [Docket No. FWS-R5-ES-2017-0056; 4500030113] RIN 1018-BC44 Endangered and Threatened Wildlife and Plants; Endangered Species Status for the Candy Darter AGENCY:

    Fish and Wildlife Service, Interior.

    ACTION:

    Final rule.

    SUMMARY:

    We, the U.S. Fish and Wildlife Service (Service), determine endangered species status under the Endangered Species Act of 1973 (Act), as amended, for the candy darter (Etheostoma osburni), a freshwater fish species from Virginia and West Virginia. This rule adds this species to the Federal List of Endangered and Threatened Wildlife.

    DATES:

    This rule is effective December 21, 2018.

    ADDRESSES:

    This final rule is available on the internet at http://www.regulations.gov and https://www.fws.gov/northeast/candydarter. Comments and materials we received, as well as supporting documentation we used in preparing this rule, are available for public inspection at http://www.regulations.gov. Comments, materials, and documentation that we considered in this rulemaking will be available by appointment, during normal business hours, at: U.S. Fish and Wildlife Service, West Virginia Ecological Services Field Office, 694 Beverly Pike, Elkins, WV 26241-9475; telephone 304-636-6586.

    FOR FURTHER INFORMATION CONTACT:

    John Schmidt, Field Supervisor, West Virginia Ecological Services Field Office, 694 Beverly Pike, Elkins, WV 26241-9475; telephone 304-636-6586. Persons who use a telecommunications device for the deaf (TDD) may call the Federal Relay Service at 800-877-8339.

    SUPPLEMENTARY INFORMATION: Previous Federal Actions

    Please refer to our October 4, 2017, proposed rule (82 FR 46197) for a detailed description of previous Federal actions concerning the candy darter. Elsewhere in today's Federal Register, we propose the designation of critical habitat for the candy darter; that proposal also discusses our intent to reestablish populations within the candy darter's historical range under section 10(j) of the Act in a future publication. And we are seeking public input on other potential recovery tools (e.g., safe harbor agreements), through the proposed critical habitat designation public comment period.

    Background

    Please refer to our October 4, 2017, proposed rule (82 FR 46197) for a summary of species information available to the Service at the time that it was published. Based on information we received during the proposed rule's public comment period, we updated the current condition discussion in the species status assessment (SSA) report to more accurately reflect the current spread level of hybridization, which is the primary threat to the species, in the candy darter's range (Service 2018). The candy darter's current condition is more degraded than we understood when we published the October 4, 2017, proposed listing rule. Consequently, because the species' current condition (i.e., the baseline or starting point for the SSA's future scenario projections) is more degraded, the species' future condition is also likely to be further degraded than we had previously estimated. With this more accurate reflection of the candy darter's current condition, the risk of extinction is greater than we had previously understood, and we have determined that the species does not meet the definition of a threatened species (as proposed). We find that endangered is the appropriate status for the candy darter (see Determination, below).

    We also received information during the public comment period that demonstrates a stronger genetic separation between candy darters in the Greenbrier watershed and the Gauley watershed. All the information was incorporated into an updated version of the SSA report, which is available online at https://www.fws.gov/northeast/candydarter.

    Summary of Biological Status and Threats

    The Act directs us to determine whether any species is an endangered species or a threatened species because of any factors affecting its continued existence. We completed a comprehensive assessment of the biological status of the candy darter and prepared a report of the assessment (SSA report), which provides a thorough account of the species' overall viability using the conservation biology principles of resiliency, redundancy, and representation (collectively, the “3Rs”). We have used the SSA report's assessment of the candy darter's current and potential future status, based on the factors influencing the species, framed in the context of the 3Rs, and information provided during the public comment period on the October 4, 2017, proposed listing rule to inform our determination of whether the candy darter meets the definition of an endangered or a threatened species (see Determination, below).

    Because we have included information below about the candy darter's 3Rs, we further define those terms here. Resiliency means having sufficiently large populations for the species to withstand stochastic events (arising from random factors). We can measure resiliency based on metrics of population health; for example, birth versus death rates and population size, if that information exists. Resilient populations are better able to withstand disturbances such as random fluctuations in birth rates (demographic stochasticity), variations in rainfall (environmental stochasticity), or the effects of human activities. Redundancy means having a sufficient number of populations for the species to withstand catastrophic events (such as a rare destructive natural event or episode involving many populations). Redundancy is about spreading the risk and can be measured through the duplication and distribution of populations across the range of the species. Generally, the greater the number of populations a species has distributed over a larger landscape, the better it can withstand catastrophic events. Representation means having the breadth of genetic makeup for the species to adapt to changing environmental conditions. Representation can be measured through the genetic diversity within and among populations and the ecological diversity (also called environmental variation or diversity) of populations across the species' range. The more representation, or diversity, a species has, the more it is capable of adapting to changes (natural or human caused) in its environment.

    In the absence of species-specific genetic and ecological diversity information, we evaluate representation based on the extent and variability of habitat characteristics within the geographical range. We define viability here as the ability of the species to persist in the wild over time and, conversely, to avoid extinction.

    Below, we summarize the conclusions of the candy darter's SSA analysis (Service 2018, entire), which can be accessed at Docket FWS-R5-ES-2017-0056 on http://www.regulations.gov and at https://www.fws.gov/northeast/candydarter. The SSA report documents the results of our comprehensive biological status review for the candy darter, including an assessment of the factors influencing its continued existence. The SSA report does not represent a decision by the Service on whether the candy darter should be listed as an endangered or a threatened species under the Act. Rather, the SSA report provides the scientific basis that informs our regulatory decision, which involves the further application of standards within the Act and its implementing regulations and policies. The Act directs us to determine whether any species is an endangered species or a threatened species (i.e., whether it meets the definition of a threatened or endangered species) because of any factors affecting its continued existence. Below, we review the biological condition of the species and its resources and the factors influencing the species and resources to assess the species' overall viability and the risks to that viability.

    Summary of Current Condition

    Historically, the candy darter consisted 35 populations in Virginia and West Virginia distributed across 7 metapopulations in the Bluestone, Lower New River, Upper Gauley, Lower Gauley, and Middle New watersheds in the Appalachian Plateaus physiographic province and the Upper New River and Greenbrier watersheds in the Valley and Ridge physiographic province. See Chapter 3 of the SSA report for more details (Service 2018, pp. 30-31).

    Within these two physiographic provinces, the candy darter has been extirpated from almost half of its historical range (17 of 35 (49 percent) known populations, and 2 of 7 (29 percent) known metapopulations), with the extirpations representing a complete loss of resiliency in those populations (or metapopulations). We qualitatively assessed the remaining (extant) populations, placing them in “low,” “moderate,” or “high” categories that represent the populations' potential to rebound after stochastic events. These categories were based on a combination of eight physical habitat, nonnative competition, and candy darter demographic metrics (see Service 2018, pp. 51, 84-102). Of the 18 extant populations, 5 (28 percent) have a current score of high or moderate to high resiliency, 9 (50 percent) have moderate resiliency, and 4 (22 percent) have low or moderate to low resiliency (see table 4 in the SSA report (Service 2018, p, 46). The five populations with higher resiliency constitute three metapopulations (the Upper Gauley in the Appalachian Plateaus physiographic province and the Greenbrier and Middle New in the Valley and Ridge physiographic province); the remaining two extant metapopulations (the Lower Gauley in the Appalachian Plateaus physiographic province and the Upper New River in the Valley and Ridge physiographic province) maintain populations with moderate and low resiliency. Therefore, we conclude the candy darter's populations currently have moderate resiliency because the four out of the five metapopulations have moderate to high resiliency.

    This loss of these candy darter populations, which represent the species' genetic, ecological, and niche diversity within its historical range, as well as the fragmentation of extant populations, has compromised the species' ability to repatriate those areas or avoid species-level effects of a catastrophic event. Based on the species' distribution and condition within each of the seven historical metapopulations (one with moderate to high internal redundancy, one with moderate internal redundancy, one with low internal redundancy, two with no internal redundancy, and two that have been extirpated), we conclude, based on the best available data, that the candy darter's current redundancy is low (Service 2018, pp. 26-28, 49-50).

    While the candy darter currently maintains representation in both the Appalachian Plateaus and Valley and Ridge physiographic provinces, only a single metapopulation in each province has a moderate to high resiliency score. As related to the species' occupation in a diversity of environmental settings, candy darters have lost representation from lower mainstem rivers and tributaries. While researchers have noted differences in the genetic, physical, behavioral, or developmental characteristics of some stream fish species based on the species' longitudinal position in the watershed (e.g., stream size) (Neville et al. 2006, pp. 911-913), but we have no data indicating candy darters exhibit similar differences based on their particular environmental setting. Although the candy darter retains representation in both the Appalachian Plateaus and Valley and Ridge physiographic provinces, the species has a reduced distribution than it had historically and likely a reduced ability to respond to stochastic and catastrophic events, thereby putting the species at increased risk of extinction from any such events (Service 2018, pp. 50-51). The available genetic data for the candy darter indicate that the Upper and Lower Gauley River metapopulations are different from the Greenbrier metapopulation. While we have no information regarding the evolutionary significance of these genetic differences to either metapopulation, the loss of either metapopulation would represent a loss to the species' genetic diversity. Therefore, we conclude that the species' representation is currently moderate to low (Service 2018, pp. 26-29, 50-51).

    The candy darter is currently distributed in five of the historical seven metapopulations. The populations within those metapopulations generally have moderate to low resiliency and redundancy scores. While the candy darter is present in the two physiographic provinces from which it is historically known, the species is not found in lower mainstem rivers and tributaries in which it once existed (Service 2018, Chapter 3). This fact leads us to conclude the candy darter's representation is also moderate to low. Therefore, our analysis under the 3Rs leads us to conclude that the current condition of the candy darter is currently moderate to low.

    Risk Factors for the Candy Darter

    Based on the candy darter's life history and habitat needs, and in consultation with species' experts from Virginia and West Virginia State and Federal agencies and academic institutions, we identified the potential stressors (negative influences), the contributing sources of those stressors, and conservation measures to address those stressors that are likely to affect the species' current condition and viability (Service 2018, pp. 32-43). We evaluated how these stressors may be currently affecting the species and whether, and to what extent, they would affect the species in the future (Service 2018, pp. 52-66). Water temperature, excessive sedimentation, habitat fragmentation, water chemistry, water flow, and nonnative competition likely influenced the species in the past and contributed to its current condition, and may continue to affect some populations in the future (Service 2018, pp. 44, 46, 52-67). However, habitat stressors are not considered to be a primary source of risk to candy darter viability in the future. Hybridization with the closely related variegate darter (Etheostoma variatum) appears to be having, and will continue to have, the greatest influence on candy darter populations and the candy darter's overall viability within the next 25 years (Service 2018, pp. 52-66). While we acknowledge there is uncertainty regarding some of the scientific data and assumptions used to assess the biological condition of the candy darter, the species' experts generally agreed with the overall methodology for assessing the candy darter's current and projected future condition, and confirmed that the results were reflective of their observations of the candy darter and its habitat.

    As mentioned above, the primary stressor to the candy darter is hybridization with the variegate darter (Service 2018, pp. 32-37), a species that is native to the Kanawha River basin below the Kanawha Falls in Fayette County, West Virginia. The Kanawha Falls serve as a natural barrier to fish dispersal from the lower Kanawha River basin (and greater Ohio River basin) upstream into the range of the candy darter in the upper Kanawha River basin. However, in the late 20th century, the variegate darter was introduced, likely by “bait bucket transfer,” into the upper Kanawha basin. Since they were first observed in the upper Kanawha basin in 1982 and 2002, variegate darters have expanded their range approximately 3 to 9 stream miles per year over the course of the last 20 or more years within the range of the candy darter. Genetic studies have demonstrated that where variegate and candy darter ranges now overlap, the two species will hybridize, and consistent, repeated contact will quickly result in “genetic swamping” (the homogenization or replacement of native genotypes) of the endemic candy darter population and eventually its complete replacement by variegate darters or hybrids (Service 2018, pp. 32-37).

    Summary of Future Conditions Analysis

    We modeled five scenarios to assess the potential viability of the candy darter at a point up to 25 years in the future (Service 2018, pp. 52-66). Two scenarios were focused on habitat change (one positive and the other negative), and three scenarios were focused on variegate darter invasion. However, the habitat change scenarios, by themselves, are not plausible scenarios because variegate darter hybridization is ongoing and highly likely to continue (see chapter 4 and appendix B of the SSA report for additional information). We chose to model all scenarios out to 25 years because we have data to reasonably predict potential habitat and variegate darter changes and their effects on the candy darter within this timeframe.

    Under the three most plausible scenarios, those that include the variegate darter invasion, the predicted rate of variegate darter expansion and hybridization remains the same, and at the end of 25 years, the candy darter will likely occur in four isolated populations and maintain little resilience, redundancy, or representation. The effects of significant positive or negative habitat changes do not alter this outcome; however, because variegate darters may be more tolerant of a wider range of habitat conditions, negative habitat changes could selectively benefit variegate darters and increase the rate at which candy darters are extirpated (Service 2018, p. 64).

    The candy darter SSA report (Service 2018, entire) contains a more detailed discussion of our evaluation of the biological status of the candy darter and the influences that may affect its continued existence. Our conclusions are based upon the best available scientific and commercial data, including the expert opinion of the species' experts (fishery biologists, aquatic ecologists, and geneticists from State and Federal agencies and academic institutions) and the SSA team members. Please see the SSA report for a complete list of the species experts and peer reviewers and their affiliations.

    Summary of Changes From the Proposed Rule

    We received information during the public comment period that concluded we had inaccurately described the current condition of some populations of the candy darter. The current condition of the candy darter populations in five streams in the Upper Gauley watershed is more degraded than we had understood when we proposed the candy darter for listing. We inaccurately stated that “[v]ariegate darters have not yet been detected in the remainder of the candy darter's range (i.e., the Upper Gauley watershed in West Virginia.” Based on comments we received regarding the spread of the variegate darter in the upper Gauley drainage, the risk of hybridization appears imminent and may already be widespread (see Summary of Comments and Recommendations, below). We incorporated this information into an updated version of the SSA report (Service 2018). The risk of extinction is higher (see Determination, below) than we characterized in the proposal to list the candy darter as a threatened species (82 FR 46197; October 4, 2017).

    Additionally, we received information during the public comment period that demonstrated that there is greater genetic differentiation between candy darter in the Greenbrier watershed and candy darter in the Gauley watershed (see Summary of Comments and Recommendations, below). We incorporated this information into an updated version of the SSA report (Service 2018).

    We reassessed our analysis (after reviewing all public comments), updated the SSA report, and, after evaluating the best available information and the Act's regulation and policies, determined that the candy darter meets the definition of an endangered species, and such designation is more appropriate than that of a threatened species as originally proposed.

    Summary of Comments and Recommendations

    In the proposed rule published on October 4, 2017 (82 FR 46197), we requested that all interested parties submit written comments on the proposal by December 4, 2017. We also contacted appropriate Federal and State agencies, scientific experts and organizations, and other interested parties and invited them to comment on the proposal. A newspaper notification inviting general public comment was published in the USA Today on October 10, 2017. We did not receive any requests for a public hearing. All substantive information provided during the comment period has either been incorporated directly into this final determination or is addressed below, as appropriate.

    Peer Reviewer Comments

    In accordance with our joint policy on peer review published in the Federal Register on July 1, 1994 (59 FR 34270) and our August 22, 2016, memorandum updating and clarifying the role of peer review of listing actions under the Act, we sought the expert opinions of six individuals (and received responses from four) with expertise in darters; fisheries, population, or landscape ecology; genetics and conservation genetics; and/or speciation and conservation biology regarding the SSA report (Service 2018). The purpose of peer review is to ensure that our designation is based on scientifically sound data, assumptions, and analyses. The peer reviewers generally concurred with our methods and conclusions and provided additional information, clarifications, and suggestions to improve the final SSA report. The SSA report and peer reviews can be found on http://www.regulations.gov under Docket No. FWS-R5-ES-2017-0056. The SSA report informed the proposed rule (82 FR 46197; October 4, 2017) and this final rule.

    Comments From States

    (1) Comment: The West Virginia Division of Natural Resources (WVDNR) and one public commenter stated that given the fact that variegate darter alleles were detected in the Upper Gauley in 2014 the spread of hybrids in the Upper Gauley drainage appears imminent and may already be widespread based on the rapid spread of hybrids in the Greenbrier drainage.

    Our Response: After reviewing how we assessed the hybridization metric, one of eight metrics in our candy darter condition model, we concluded that we had previously underestimated the risk of hybridization in the Upper Gauley. Therefore, we have updated the analysis in the SSA report to address this concern. This information was the primary reason we changed our determination from threatened to endangered.

    (2) Comment: The WVDNR stated that the Gauley and Greenbrier river populations of candy darter have a high level of genetic differentiation that borders on species-level differentiation. The Greenbrier River population appears to be on a definite “trajectory to extinction.” Loss of candy darter in the Greenbrier river would drastically reduce genetic diversity of the species and leave the Gauley River and Virginia populations separated by substantial geographic distance and two physical barriers (i.e., Summersville and Bluestone dams).

    Our Response: The best available genetic information suggests genetic differences exist between these watersheds. We have updated the SSA report to reflect the importance of these genetic differences.

    Public Comments

    (3) Comment: One commenter provided additional supporting evidence of the genetic differentiation between the Greenbrier and Gauley metapopulations.

    Our Response: We incorporated the information into our SSA report.

    (4) Comment: One commenter believed that the candy darter has been extirpated from 77.2 its range rather than 49 percent, as we stated in the proposed rule. They also stated that the situation is likely worse than that because three of the four populations in the Upper Gauley that are labeled as “extant candy darter populations” have not been genetically analyzed; if they were genetically analyzed, they may fall into the category of “extant candy darter population with variegate darter alleles.”

    Our Response: This final determination relies on the best scientific information available. At this time, we do not have genetic information (or evidence otherwise) to fully evaluate the genetics of the populations in the Gauley; therefore, we do not assume they are candy darter with variegate darter alleles. We we recognize uncertainty in the data and that the situation may be worse than we are aware.

    (5) Comment: Three commenters recommended exemptions for activities for the Service to consider in the event that we drafted a species-specific rule under section 4(d) of the Act (“4(d) rule”).

    Our Response: The Service has determined that the candy darter meets the definition of an endangered species, and the Act does not allow for the promulgation of a 4(d) rule when a species is listed as endangered.

    Determination

    Section 4 of the Act (16 U.S.C. 1533), and its implementing regulations at 50 CFR part 424, set forth the procedures for adding species to the Federal Lists of Endangered and Threatened Wildlife and Plants. Under section 4(a)(1) of the Act, we may list a species based on (A) The present or threatened destruction, modification, or curtailment of its habitat or range; (B) overutilization for commercial, recreational, scientific, or educational purposes; (C) disease or predation; (D) the inadequacy of existing regulatory mechanisms; or (E) other natural or manmade factors affecting its continued existence.

    We have carefully assessed the best scientific and commercial information available regarding the past, present, and future threats to the candy darter. Our analysis of this information indicates that, at the species level, hybridization with variegate darters (Factor E) is the most influential factor affecting the candy darter now and into the future. Excessive sedimentation and increased water temperatures degraded once-suitable habitat (Factor A) and likely caused historical declines of the candy darter. We also analyzed existing regulatory mechanisms (such as the Federal Clean Water Act of 1977 (33 U.S.C. 1251 et seq.), Surface Mining Control and Reclamation Act of 1977 (30 U.S.C. 1234-1328), West Virginia Water Pollution Control Act (WVSC § 22-11) and the increased implementation of forestry and construction “best management practices” designed to reduce erosion and sedimentation) (Factor D) to reduce or eliminate sedimentation and found that these mechanisms were not sufficient to protect the species from extinction as excessive sedimentation and increased water temperatures continue to affect some of the remaining populations. There may be additional infrastructure projects (e.g., roads, pipeline, etc.) that increase sediment loading within the range of the candy darter as a result of stream crossings or forest clearing for permanent rights of way. Additionally, the current level of habitat fragmentation (Factor A) isolates some populations, which reduces gene flow and limits the potential for the species to colonize or recolonize streams if habitat conditions change. Other factors such as flow alterations and water quality degradation that affect habitat (Factor A), and the stocking of nonnative species that can eat (Factor C) or outcompete (Factor E) the candy darter are not expected to cause species-level effects. In addition, we have no evidence that overutilization (Factor B) or disease (Factor C) is affecting individuals or populations of candy darters.

    Active hybridization with variegate darters has occurred or is currently occurring in multiple streams within the Lower New, Lower Gauley, and Greenbrier River watersheds in West Virginia (Service 2018, p. 37). Although variegate darter individuals have not yet been detected in the remainder of the candy darter's range (i.e., the Middle New and Upper New watersheds in Virginia), variegate darter alleles have been detected in two separate locations in the Upper Gauley watershed, indicating that hybridization occurred at one time and currently likely underway. Additionally, the risk is moderately high that variegate darter introductions will continue to occur in these watersheds because if watersheds occupied by variegate darters (and hybrids) are adjacent to candy darter watersheds, the likelihood that variegate darters will be collected as bait and transported into an adjacent candy darter watershed is increased. When this happens, variegate darters ultimately replace most candy darter populations throughout the candy darter's range. The Act defines an endangered species as any species that is “in danger of extinction throughout all or a significant portion of its range.” We find that an endangered species status is appropriate for the candy darter because the species is facing a catastrophic threat from which the risk of extinction is imminent and certain. The introduction of variegate darters is occurring, and the consequence that it will extirpate any local candy darter population that variegate darters come into sustained contact with is imminent and certain across the species' remaining range. As a result of their limited range and/or population size, narrowly endemic species are inherently vulnerable to extinction when subject to elevated threats. The candy darter has a moderately small range, which has only become more restricted, as 77 percent (27 of 35 populations (see SSA report, table 4)) of its range has been lost through historical land use changes and/or has been invaded by the variegate darter. Therefore, we conclude that the current risk of extinction of the candy darter is such that it does not meet the definition of a threatened species under the Act.

    The Act defines an endangered species as any species that is “in danger of extinction throughout all or a significant portion of its range” and a threatened species as any species “that is likely to become endangered throughout all or a significant portion of its range within the foreseeable future.” We find that the candy darter is presently in danger of extinction throughout its entire range based on the severity and immediacy of threats currently affecting the species. The overall range has been significantly reduced, and the remaining populations are threatened by hybridization and, to a lesser extent, a combination of other threats, reducing the overall viability of the species. The risk of extinction is high because the remaining populations are isolated and the threat of hybridization is ongoing and increasing. Therefore, on the basis of the best available scientific and commercial data, we are listing the candy darter as endangered in accordance with sections 3(6) and 4(a)(1) of the Act. We find that a threatened species status is not appropriate for the candy darter because of the reasons previously outlined and because the threats, which occur throughout the species' range, are expected to continue to increase, putting the species at risk of extinction now.

    Under the Act and our implementing regulations, a species may warrant listing if it is endangered or threatened throughout all or a significant portion of its range. Because we have determined that the candy darter is in danger of extinction throughout its range, we find it unnecessary to proceed to an evaluation of potentially significant portions of the range. Where the best available information allows the Services to determine a status for the species rangewide, that determination should be given conclusive weight because a rangewide determination of status more accurately reflects the species' degree of imperilment and better promotes the purposes of the statute. Under this reading, we should first consider whether listing is appropriate based on a rangewide analysis and proceed to conduct a “significant portion of its range” analysis if, and only if, a species does not qualify for listing as either endangered or threatened according to the “all” language. We note that the court in Desert Survivors v. Department of the Interior, No. 16-cv-01165-JCS, 2018 WL 4053447 (N.D. Cal. Aug. 24, 2018), did not address this issue, and our conclusion is therefore consistent with the opinion in that case.

    Available Conservation Measures

    Conservation measures provided to species listed as endangered or threatened species under the Act include recognition, recovery actions, requirements for Federal protection, and prohibitions against certain practices. Recognition through listing results in public awareness, and conservation by Federal, state, Tribal, and local agencies; private organizations; and individuals. The Act encourages cooperation with the States and requires that recovery actions be carried out for all listed species. The protection required by Federal agencies and the prohibitions against certain activities are discussed, in part, below.

    The primary purpose of the Act is the conservation of endangered and threatened species and the ecosystems upon which they depend. The ultimate goal of such conservation efforts is the recovery of these listed species, so that they no longer need the protective measures of the Act. Subsection 4(f) of the Act requires the Service to develop and implement recovery plans for the conservation of endangered and threatened species. The recovery planning process involves the identification of actions that are necessary to halt or reverse the species' decline by addressing the threats to its survival and recovery. The goal of this process is to restore listed species to a point where they are secure, self-sustaining, and functioning components of their ecosystems.

    Recovery planning includes the development of a recovery outline shortly after a species is listed and preparation of a draft and final recovery plan. The recovery outline guides the immediate implementation of urgent recovery actions and describes the process to be used to develop a recovery plan. As part of our conservation strategy for the candy darter, which will inform the forthcoming recovery outline and informs the proposed critical habitat rule published elsewhere in today's Federal Register, we identified the need to reestablish candy darter populations within areas of its historical range. Because the candy darter is extirpated from some areas and natural repopulation is not possible without human assistance, use of a 10(j) rule under the Act may be one appropriate tool to achieve this recovery objective. An overview of the process to establish an experimental population under section 10(j) of the Act is described in detail in the proposed critical habitat rule published elsewhere in today's Federal Register. In addition to using the authorities under 10(j) of the Act in areas not currently occupied by the candy darter, the condition of existing candy darter populations may be improved by working with non-Federal landowners through safe harbor agreements, authorized under section 10(a)(1)(A) of the Act. More information about safe harbor agreements can be found online at: https://www.fws.gov/endangered/landowners/safe-harbor-agreements.html. We intend to fully explore all of the appropriate recovery tools for the candy darter with our State, Federal, non-governmental, and private partners.

    The recovery plan identifies site-specific management actions that set a trigger for review of whether a species remains endangered or may be reclassified from endangered to threatened (“downlisted”) or removed from the Lists of Endangered and Threatened Wildlife and Plants (“delisted”), and methods for monitoring recovery progress. Recovery plans also establish a framework for agencies to coordinate their recovery efforts and provide estimates of the cost of implementing recovery tasks. Recovery teams (composed of species experts, Federal and State agencies, nongovernmental organizations, and stakeholders) are often established to develop recovery plans. When completed, the recovery outline, draft recovery plan, and the final recovery plan will be available on our website (http://www.fws.gov/endangered) or from the person listed under FOR FURTHER INFORMATION CONTACT.

    Implementation of recovery actions generally requires the participation of a broad range of partners, including other Federal agencies, states, Tribes, nongovernmental organizations, businesses, and private landowners. Examples of recovery actions include habitat restoration (e.g., restoration of native vegetation), research, captive propagation and reintroduction, and outreach and education. The recovery of many listed species cannot be accomplished solely on Federal lands because their range may occur primarily or solely on non-Federal lands. Achieving recovery of these species requires cooperative conservation efforts on private, state, and Tribal lands.

    Following publication of this final listing rule, funding for recovery actions will be available from a variety of sources, including Federal budgets, state programs, and cost share grants for non-Federal landowners, the academic community, and nongovernmental organizations. In addition, pursuant to section 6 of the Act, the States of Virginia and West Virginia will be eligible for Federal funds to implement management actions that promote the recovery of the candy darter. Information on our grant programs that are available to aid species recovery can be found at: http://www.fws.gov/grants.

    Please let us know if you are interested in participating in recovery efforts for the candy darter. Additionally, we invite you to submit any new information on this species whenever it becomes available and any information you may have for recovery planning purposes (see FOR FURTHER INFORMATION CONTACT).

    Section 7(a) of the Act requires Federal agencies to evaluate their actions with respect to any species that is listed as an endangered or threatened species and with respect to its critical habitat, if any is designated. Regulations implementing this interagency cooperation provision of the Act are codified at 50 CFR part 402. Section 7(a)(2) of the Act requires Federal agencies to ensure that activities they authorize, fund, or carry out are not likely to jeopardize the continued existence of any endangered or threatened species or destroy or adversely modify its critical habitat. If a Federal action may affect a listed species or its critical habitat, the responsible Federal agency must enter into consultation with the Service.

    Federal agency actions within the species' habitat that may require consultation as described in the preceding paragraph include, but are not limited to, management (e.g., captive propagation) and any other landscape-altering activities on Federal lands administered by the U.S. Forest Service (Monongahela and the George Washington and Jefferson National Forests) and the National Park Service; issuance of section 404 Clean Water Act (33 U.S.C. 1251 et seq.) permits by the U.S. Army Corps of Engineers; and construction and maintenance of roads or highways by the Federal Highway Administration.

    The Act and its implementing regulations set forth a series of general prohibitions and exceptions that apply to endangered wildlife. The prohibitions of section 9(a)(1) of the Act, codified at 50 CFR 17.21, make it illegal for any person subject to the jurisdiction of the United States to take (which includes harass, harm, pursue, hunt, shoot, wound, kill, trap, capture, or collect; or to attempt any of these) endangered wildlife within the United States or on the high seas. In addition, it is unlawful to import; export; deliver, receive, carry, transport, or ship in interstate or foreign commerce in the course of commercial activity; or sell or offer for sale in interstate or foreign commerce any listed species. It is also illegal to possess, sell, deliver, carry, transport, or ship any such wildlife that has been taken illegally. Certain exceptions apply to employees of the Service, the National Marine Fisheries Service, other Federal land management agencies, and State conservation agencies.

    We may issue permits to carry out otherwise prohibited activities involving endangered wildlife under certain circumstances. Regulations governing permits are codified at 50 CFR 17.22. With regard to endangered wildlife, a permit may be issued for the following purposes: For scientific purposes, to enhance the propagation or survival of the species, and for incidental take in connection with otherwise lawful activities. There are also certain statutory exemptions from the prohibitions, which are found in sections 9 and 10 of the Act.

    It is our policy, as published in the Federal Register on July 1, 1994 (59 FR 34272), to identify to the maximum extent practicable at the time a species is listed, those activities that would or would not constitute a violation of section 9 of the Act. The intent of this policy is to increase public awareness of the effect of a final listing on proposed and ongoing activities within the range of a listed species. Based on the best available information, the following actions are unlikely to result in a violation of section 9, if these activities are carried out in accordance with existing regulations and permit requirements; this list is not comprehensive:

    • Normal agricultural practices, including herbicide and pesticide use, carried out in accordance with any existing regulations and with permit and label requirements.

    Based on the best available information, the following activities may potentially result in a violation of section 9 the Act; this list is not comprehensive:

    (1) Introduction of variegate darters into suitable candy darter habitat;

    (2) Stocking of nonnative species into suitable candy darter habitat;

    (3) Destruction or alteration of the habitat of the candy darter (e.g., unpermitted instream dredging, impoundment, water diversion or withdrawal, channelization, discharge of fill material) that impairs essential behaviors such as breeding, feeding, or sheltering, or results in killing or injuring a candy darter; and

    (4) Discharges or dumping of toxic chemicals or other pollutants into waters supporting the candy darter that kills or injures individuals, or otherwise impairs essential life-sustaining behaviors such as breeding, feeding, or finding shelter.

    Questions regarding whether specific activities would constitute a violation of section 9 of the Act should be directed, as follows:

    • In West Virginia, to the West Virginia Ecological Services Field Office (see FOR FURTHER INFORMATION CONTACT); or

    • In Virginia, to the Southwestern Virginia Field Office (330 Cummings Street, Abingdon, VA 24210-3208; telephone 276-623-1233).

    Required Determinations National Environmental Policy Act (42 U.S.C. 4321 et seq.)

    We have determined that environmental assessments and environmental impact statements, as defined under the authority of the National Environmental Policy Act (NEPA; 42 U.S.C. 4321 et seq.), need not be prepared in connection with listing a species as an endangered or threatened species under the Endangered Species Act. We published a notice outlining our reasons for this determination in the Federal Register on October 25, 1983 (48 FR 49244).

    Government-to-Government Relationship With Tribes

    In accordance with the President's memorandum of April 29, 1994 (Government-to-Government Relations with Native American Tribal Governments; 59 FR 22951), Executive Order 13175 (Consultation and Coordination With Indian Tribal Governments), and the Department of the Interior's manual at 512 DM 2, we readily acknowledge our responsibility to communicate meaningfully with recognized Federal Tribes on a government-to-government basis. In accordance with Secretarial Order 3206 of June 5, 1997 (American Indian Tribal Rights, Federal-Tribal Trust Responsibilities, and the Endangered Species Act), we readily acknowledge our responsibilities to work directly with Tribes in developing programs for healthy ecosystems, to acknowledge that tribal lands are not subject to the same controls as Federal public lands, to remain sensitive to Indian culture, and to make information available to tribes. The candy darter does not occur on federally recognized Tribal or Tribal interest lands.

    References Cited

    A complete list of references cited in this rulemaking is available on the internet at http://www.regulations.gov and upon request from the West Virginia Ecological Services Field Office (see FOR FURTHER INFORMATION CONTACT).

    Authors

    The primary authors of this final rule are the staff members of the Services' Species Assessment Team, the West Virginia Ecological Services Field Office, and the Southwestern Virginia Ecological Services Field Office.

    List of Subjects in 50 CFR Part 17

    Endangered and threatened species, Exports, Imports, Reporting and recordkeeping requirements, Transportation.

    Regulation Promulgation

    Accordingly, we amend part 17, subchapter B of chapter I, title 50 of the Code of Federal Regulations, as follows:

    PART 17—ENDANGERED AND THREATENED WILDLIFE AND PLANTS 1. The authority citation for part 17 continues to read as follows: Authority:

    16 U.S.C. 1361-1407; 1531-1544; and 4201-4245, unless otherwise noted.

    2. Amend § 17.11(h) by adding, in alphabetical order under FISHES, an entry for “Darter, candy” to the List of Endangered and Threatened Wildlife to read as follows:
    § 17.11 Endangered and threatened wildlife.

    (h) * * *

    Common name Scientific name Where listed Status Listing citations and applicable rules *         *         *         *         *         *         * Fishes *         *         *         *         *         *         * Darter, candy Etheostoma osburni Wherever found E 83 FR [insert Federal Register page where the document begins], 11/21/2018. *         *         *         *         *         *         *
    Dated: September 6, 2018. James W. Kurth, Deputy Director, U.S. Fish and Wildlife Service, Exercising the Authority of the Director, U.S. Fish and Wildlife Service.
    [FR Doc. 2018-25316 Filed 11-20-18; 8:45 am] BILLING CODE 4333-15-P
    DEPARTMENT OF COMMERCE National Oceanic and Atmospheric Administration 50 CFR Part 679 [Docket No. 170816769-8162-02] RIN 0648-XG639 Fisheries of the Exclusive Economic Zone Off Alaska; Pacific Cod by Catcher/Processors Using Trawl Gear in the Central Regulatory Area of the Gulf of Alaska AGENCY:

    National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.

    ACTION:

    Temporary rule; closure.

    SUMMARY:

    NMFS is prohibiting retention of Pacific cod by catcher/processors using trawl gear in the Central Regulatory Area of the Gulf of Alaska (GOA). This action is necessary because the 2018 Pacific cod apportionment for catcher/processors using trawl gear in the Central Regulatory Area of the GOA has been reached.

    DATES:

    Effective 1200 hours, Alaska local time (A.l.t.), November 19, 2018, through 2400 hours, A.l.t., December 31, 2018.

    FOR FURTHER INFORMATION CONTACT:

    Josh Keaton, 907-586-7228.

    SUPPLEMENTARY INFORMATION:

    NMFS manages the groundfish fishery in the GOA exclusive economic zone according to the Fishery Management Plan for Groundfish of the Gulf of Alaska (FMP) prepared by the North Pacific Fishery Management Council under authority of the Magnuson-Stevens Fishery Conservation and Management Act. Regulations governing fishing by U.S. vessels in accordance with the FMP appear at subpart H of 50 CFR part 600 and 50 CFR part 679.

    The 2018 Pacific cod apportionment for catcher/processors using trawl gear in the Central Regulatory Area of the GOA is 253 metric tons (mt) as established by the final 2018 and 2019 harvest specifications for groundfish of the GOA (83 FR 8768, March 1, 2018).

    In accordance with § 679.20(d)(2), the Administrator, Alaska Region, NMFS, has determined that the 2018 Pacific cod apportionment for catcher/processors using trawl gear in the Central Regulatory Area of the GOA will be reached. Therefore, NMFS is requiring that Pacific cod by catcher/processors using trawl gear in the Central Regulatory Area of the GOA be treated as prohibited species in accordance with § 679.21(b).

    Classification

    This action responds to the best available information recently obtained from the fishery. The Assistant Administrator for Fisheries, NOAA (AA), finds good cause to waive the requirement to provide prior notice and opportunity for public comment pursuant to the authority set forth at 5 U.S.C. 553(b)(B) as such requirement is impracticable and contrary to the public interest. This requirement is impracticable and contrary to the public interest as it would prevent NMFS from responding to the most recent fisheries data in a timely fashion and would delay prohibiting the retention of Pacific cod by catcher/processors using trawl gear in the Central Regulatory Area of the GOA. NMFS was unable to publish a notice providing time for public comment because the most recent, relevant data only became available as of November 15, 2018.

    The AA also finds good cause to waive the 30-day delay in the effective date of this action under 5 U.S.C. 553(d)(3). This finding is based upon the reasons provided above for waiver of prior notice and opportunity for public comment.

    This action is required by § 679.20 and § 679.21 and is exempt from review under Executive Order 12866.

    Authority:

    16 U.S.C. 1801 et seq.

    Dated: November 16, 2018. Karen H. Abrams, Acting Director, Office of Sustainable Fisheries, National Marine Fisheries Service.
    [FR Doc. 2018-25399 Filed 11-16-18; 4:15 pm] BILLING CODE 3510-22-P
    83 225 Wednesday, November 21, 2018 Notices ADMINISTRATIVE CONFERENCE OF THE UNITED STATES Notice of Public Meeting of the Assembly of the Administrative Conference of the United States AGENCY:

    Administrative Conference of the United States.

    ACTION:

    Notice.

    SUMMARY:

    Pursuant to the Federal Advisory Committee Act, the Assembly of the Administrative Conference of the United States will hold a meeting to consider five proposed recommendations and to conduct other business. This meeting will be open to the public.

    DATES:

    The meeting will take place on Thursday, December 13, 2018, 1:00 p.m. to 5:15 p.m., and Friday, December 14, 2018, 9:00 a.m. to 11:45 a.m. The meeting may adjourn early if all business is finished.

    ADDRESSES:

    The meeting will be held at the George Washington University Law School, Jacob Burns Moot Court Room, 2000 H Street NW, Washington, DC 20052.

    FOR FURTHER INFORMATION CONTACT:

    Shawne McGibbon, General Counsel (Designated Federal Officer), Administrative Conference of the United States, Suite 706 South, 1120 20th Street NW, Washington, DC 20036; Telephone 202-480-2080; email [email protected].

    SUPPLEMENTARY INFORMATION:

    The Administrative Conference of the United States makes recommendations to federal agencies, the President, Congress, and the Judicial Conference of the United States regarding the improvement of administrative procedures (5 U.S.C. 594). The membership of the Conference, when meeting in plenary session, constitutes the Assembly of the Conference (5 U.S.C. 595).

    Agenda: The Assembly will consider five proposed recommendations as described below:

    Recusal Rules for Administrative Adjudicators. This proposed recommendation urges agencies to adopt procedural regulations governing the recusal of adjudicators—as distinct from the ethics laws and regulations generally applicable to all federal employees—and provides guidance on how such regulations should be promulgated and enforced. The proposed recommendation expands upon ACUS Recommendation 2016-4, Evidentiary Hearings Not Required by the Administrative Procedure Act, and revisits parts of the recommendation proposed by the Committee on Adjudication entitled Administrative Judges. Unlike these earlier recommendations, the proposed recommendation covers both administrative law judges (ALJs) and non-ALJ adjudicators.

    Public Availability of Adjudication Rules. This proposed recommendation offers best practices to agencies for enhancing the accessibility of the procedural rules that govern the adjudications they conduct. Among other things, it encourages agencies to make procedural rules for adjudications and related guidance documents available on their websites and to organize those materials in a way that allows both parties appearing before the agencies and members of the public to easily access the documents and understand their legal significance.

    Regulations.gov and the Federal Docket Management System (FDMS). This proposed recommendation offers suggested improvements to Regulations.gov, the website that allows the public to comment on many federal agencies' rulemaking proposals. It provides recommendations to the governing body of Regulations.gov, called the eRulemaking Program, and to agencies that participate in Regulations.gov for ensuring that rulemaking materials on Regulations.gov are easily searchable and categorized consistently and clearly.

    Public Engagement in Rulemaking. This proposed recommendation offers strategies for agencies to enhance public engagement prior to and during informal rulemaking. It encourages agencies to invest resources in a way that maximizes the probability that rule-writers obtain high quality public information as early in the process as possible. It recommends expanding the use of requests for information and advance notices of proposed rulemaking, targeting outreach to reach individuals who might otherwise be unlikely to participate, and taking advantage of in-person engagement opportunities to solicit stakeholder input and support future informed participation.

    Public-Private Partnerships. This proposed recommendation offers agencies guidance on legal and other considerations for participating in public-private partnerships. It commends to agencies a Guide to Legal Issues Encountered in Public-Private Partnerships, published by an interagency working group convened by the Office of the Chairman of the Administrative Conference, and proposes mechanisms that allow agencies to share resources and best practices with one another for purposes of creating and maintaining public-private partnerships.

    Additional information about the proposed recommendations and the order of the agenda, as well as other materials related to the meeting, can be found at the 70th Plenary Session page on the Conference's website: https://www.acus.gov/meetings-and-events/plenary-meeting/70th-plenary-session.

    Public Participation: The Conference welcomes the attendance of the public at the meeting, subject to space limitations, and will make every effort to accommodate persons with disabilities or special needs. Members of the public who wish to attend in person are asked to RSVP online at the 70th Plenary Session web page shown above, no later than two days before the meeting, in order to facilitate entry. Members of the public who attend the meeting may be permitted to speak only with the consent of the Chairman and the unanimous approval of the members of the Assembly. If you need special accommodations due to disability, please inform the Designated Federal Officer noted above at least 7 days in advance of the meeting. The public may also view the meeting through a live webcast, which will be available at https://www.youtube.com/user/gwlawschool during the course of the event. At the conclusion of the event, the webcast will be archived and available for later viewing on the 70th Plenary Session web page.

    Written Comments: Persons who wish to comment on any of the proposed recommendations may do so by submitting a written statement either online by clicking “Submit a Comment” on the 70th Plenary Session web page shown above or by mail addressed to: December 2018 Plenary Session Comments, Administrative Conference of the United States, Suite 706 South, 1120 20th Street NW, Washington, DC 20036. Written submissions must be received no later than 10:00 a.m. (EDT), Friday, December 7, 2018, to assure consideration by the Assembly.

    Dated: November 16, 2018. Shawne McGibbon, General Counsel.
    [FR Doc. 2018-25401 Filed 11-20-18; 8:45 am] BILLING CODE 6110-01-P
    DEPARTMENT OF AGRICULTURE Submission for OMB Review; Comment Request November 16, 2018.

    The Department of Agriculture has submitted the following information collection requirement(s) to OMB for review and clearance under the Paperwork Reduction Act of 1995, Public Law 104-13. Comments are requested regarding (1) whether the collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility; (2) the accuracy of the agency's estimate of burden including the validity of the methodology and assumptions used; (3) ways to enhance the quality, utility and clarity of the information to be collected; and (4) ways to minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology.

    Comments regarding this information collection received by December 21, 2018 will be considered. Written comments should be addressed to: Desk Officer for Agriculture, Office of Information and Regulatory Affairs, Office of Management and Budget (OMB), New Executive Office Building, 725-17th Street NW, Washington, DC 20502. Commenters are encouraged to submit their comments to OMB via email to: [email protected] or fax (202) 395-5806 and to Departmental Clearance Office, USDA, OCIO, Mail Stop 7602, Washington, DC 20250-7602. Copies of the submission(s) may be obtained by calling (202) 720-8958.

    An agency may not conduct or sponsor a collection of information unless the collection of information displays a currently valid OMB control number and the agency informs potential persons who are to respond to the collection of information that such persons are not required to respond to the collection of information unless it displays a currently valid OMB control number.

    Food Safety and Inspection Service

    Title: Notice of Request for a New Information Collection: (Consumer Research on the Safe Handling Instructions Label for Raw and Partially Cooked Meat and Poultry Products and Labeling Statements for Ready-to-Eat and Not-Ready-to-Eat Products).

    OMB Control Number: 0583-New.

    Summary of Collection: The Food Safety and Inspection Service (FSIS) has been delegated the authority to exercise the functions of the Secretary as provided in the Federal Meat Inspection Act (FMIA) (21 U.S.C. 601 et seq.), the Poultry Products Inspection Act (PPIA) (21 U.S.C. 451, et seq.), and the Egg Products Inspection Act (EPIA) (21 U.S.C. 1031). These statues mandate that FSIS protect the public by ensuring that meat, poultry, and egg products are safe, wholesome, unadulterated, and properly labeled and packaged.

    Need and Use of the Information: FSIS is announcing its intention to collect information in the form of consumer research that will include a web-based experimental study and a behavior change study to help inform potential revisions to the current Safe Handling Instructions (SHI) label and assess whether a label revision would improve consumer food safety behaviors. FSIS also will collect information on consumer use and understanding of the labeling on ready-to-eat (RTE) and not-ready-to-eat (NRTE) meat and poultry products, in particular consumers' ability to discern between the two types of products and to ensure that NRTE products that may appear to be ready to eat are thoroughly cooked.

    Description of Respondents: Individuals or households.

    Number of Respondents: 73,395.

    Frequency of Responses: Reporting: On occasion.

    Total Burden Hours: 5,115.

    Ruth Brown, Departmental Information Collection Clearance Officer.
    [FR Doc. 2018-25395 Filed 11-20-18; 8:45 am] BILLING CODE 3410-DM-P
    DEPARTMENT OF AGRICULTURE Submission for OMB Review; Comment Request November 16, 2018.

    The Department of Agriculture has submitted the following information collection requirement(s) to OMB for review and clearance under the Paperwork Reduction Act of 1995, Public Law 104-13. Comments are requested regarding (1) whether the collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility; (2) the accuracy of the agency's estimate of burden including the validity of the methodology and assumptions used; (3) ways to enhance the quality, utility and clarity of the information to be collected; and (4) ways to minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology.

    Comments regarding this information collection received by December 21, 2018 will be considered. Written comments should be addressed to: Desk Officer for Agriculture, Office of Information and Regulatory Affairs, Office of Management and Budget (OMB), New Executive Office Building, 725 17th Street NW, Washington, DC 20502. Commenters are encouraged to submit their comments to OMB via email to: [email protected] or fax (202) 395-5806 and to Departmental Clearance Office, USDA, OCIO, Mail Stop 7602, Washington, DC 20250-7602. Copies of the submission(s) may be obtained by calling (202) 720-8958.

    An agency may not conduct or sponsor a collection of information unless the collection of information displays a currently valid OMB control number and the agency informs potential persons who are to respond to the collection of information that such persons are not required to respond to the collection of information unless it displays a currently valid OMB control number.

    National Institute of Food and Agriculture

    Title: Organizational Information.

    OMB Control Number: 0524-0026.

    Summary of Collection: The National Institute of Food and Agriculture (NIFA) has primary responsibility for providing linkages between the Federal and State components of a broad-based, national agricultural research, extension, and higher education system. Focused on national issues, its purpose is to represent the Secretary of Agriculture and the intent of Congress by administering formula and grant funds appropriated for agricultural research, extension, and higher education. Before awards can be made, certain information is required from applicant to effectively assess the potential recipient's capacity to manage Federal funds. NIFA will collection information using form NIFA 666, “Organizational Information.”

    Need and Use of the Information: NIFA will collect information to determine that applicants recommended for awards will be responsible recipients of Federal funds. The information pertains to organizational management and financial matters of the potential grantee. If the information were not collected, it would not be possible to determine that the prospective grantees are responsible.

    Description of Respondents: Not-for-profit institutions; Business or other for-profit; Individuals or households; State, Local, or Tribal Government; Federal Government.

    Number of Respondents: 150.

    Frequency of Responses: Reporting: On occasion.

    Total Burden Hours: 945.

    Ruth Brown, Departmental Information Collection Clearance Officer.
    [FR Doc. 2018-25403 Filed 11-20-18; 8:45 am] BILLING CODE 3410-09-P
    CHEMICAL SAFETY AND HAZARD INVESTIGATION BOARD Sunshine Act Meeting TIME AND DATE:

    10 a.m. CST, December 12, 2018.

    PLACE:

    University of Wisconsin—Superior, Yellowjacket Union located at Belknap and Union Ave.

    STATUS:

    Open to the public.

    MATTERS TO BE CONSIDERED:

    The Chemical Safety and Hazard Investigation Board (CSB) will convene a public town hall meeting on Wednesday December 12, 2018, starting at 10:00 a.m. CST in the Yellowjacket Union located at Belknap and Union Ave at the University of Wisconsin—Superior. CSB investigative staff will present a factual update on the Husky Refinery fire which occurred on April 28, 2018. Staff presentations are preliminary and are intended to allow the Board to consider in a public forum the issues and factors involved in this case. The Board will provide an opportunity for public comment.

    Additional Information

    The meeting is free and open to the public. If you require a translator or interpreter, please notify the individual listed below as the Contact Person for Further Information, at least three business days prior to the meeting.

    The CSB is an independent Federal agency charged with investigating accidents and hazards that result, or may result, in the catastrophic release of extremely hazardous substances. The agency's Board Members are appointed by the President and confirmed by the Senate. CSB investigations look into all aspects of chemical accidents and hazards, including physical causes such as equipment failure as well as inadequacies in regulations, industry standards, and safety management systems.

    Public Comment

    The time provided for public statements will depend upon the number of people who wish to speak. The public comments will be directed towards the board and facilitated by the Interim Executive. Speakers should assume that their presentations will be limited to three minutes or less, but commenters may submit written statements for the record.

    CONTACT PERSON FOR MORE INFORMATION:

    Hillary Cohen, Communication Manager, at [email protected] or (202) 446-8094. Further information about the CSB and this public meeting can be found on the CSB website at: www.csb.gov.

    Dated: November 19, 2018. Raymond Porfiri, Deputy General Counsel, Chemical Safety and Hazard Investigation Board.
    [FR Doc. 2018-25534 Filed 11-19-18; 4:15 pm] BILLING CODE 6350-01-P
    CIVIL RIGHTS COMMISSION Sunshine Act Meeting Notice AGENCY:

    United States Commission on Civil Rights.

    ACTION:

    Notice of Commission Telephonic Business Meeting.

    DATES:

    Tuesday, November 27, 2018, at 11:00 a.m. ET.

    ADDRESSES:

    Meeting to take place by telephone.

    FOR FURTHER INFORMATION CONTACT:

    Brian Walch, (202) 376-8371, [email protected].

    SUPPLEMENTARY INFORMATION:

    This business meeting is open to the public by telephone only.

    Participant Access Instructions:

    Public call-in information will be available in advance of the meeting at www.usccr.gov, https://twitter.com/USCCRgov and https://www.facebook.com/USCCRgov/.

    Meeting Agenda I. Approval of Agenda II. Discussion of Discovery Plan III. Adjourn Meeting. Dated: November 19, 2018. Brian Walch, Director, Communications and Public Engagement.
    [FR Doc. 2018-25588 Filed 11-19-18; 4:15 pm] BILLING CODE 6335-01-P
    DEPARTMENT OF COMMERCE International Trade Administration [C-489-825] Heavy Walled Rectangular Welded Carbon Steel Pipes and Tubes From the Republic of Turkey: Affirmative Final Results of Countervailing Duty Administrative Review AGENCY:

    Enforcement and Compliance, International Trade Administration, Department of Commerce.

    SUMMARY:

    The Department of Commerce determines that Ozdemir Boru Profil San. Ve Tic. Ltd. Sti. (Ozdemir), an exporter/producer of heavy walled rectangular welded carbon steel pipes and tubes (HWR pipes and tubes) from the Republic of Turkey (Turkey), received countervailable subsidies during the period of review (POR) December 28, 2015, through April 25, 2016, and September 12, 2016, through December 31, 2016.

    DATES:

    Applicable November 21, 2018.

    FOR FURTHER INFORMATION CONTACT:

    Brian Smith or Janae Martin, AD/CVD Operations, Office VIII, Enforcement and Compliance, International Trade Administration, U.S. Department of Commerce, 1401 Constitution Avenue NW, Washington, DC 20230; telephone: (202) 482-1766 or (202) 482-0238, respectively.

    SUPPLEMENTARY INFORMATION: Background

    On August 14, 2018, Commerce published the Preliminary Results of the administrative review.1 Commerce gave interested parties an opportunity to comment on the Preliminary Results.2 No interested parties submitted comments. Commerce has conducted this review in accordance with section 751(a)(1)(A) of the Tariff Act of 1930, as amended (the Act).

    1See Heavy Walled Rectangular Welded Carbon Steel Pipes and Tubes from the Republic of Turkey: Preliminary Results of Countervailing Duty Administrative Review; 2016, 83 FR 40228 (August 14, 2018) (Preliminary Results), and accompanying Preliminary Decision Memorandum (PDM).

    2See Preliminary Results, 83 FR at 40228.

    Scope of the Order

    The products covered by the order are shipments of certain heavy walled rectangular welded steel pipes and tubes of rectangular (including square) cross section, having a nominal wall thickness of not less than 4 mm. The merchandise includes, but is not limited to, the American Society for Testing and Materials (ASTM) A-500, grade B specifications, or comparable domestic or foreign specifications.

    Included products are those in which: (1) Iron predominates, by weight, over each of the other contained elements; (2) the carbon content is 2 percent or less, by weight; and (3) none of the elements below exceed the quantity, by weight, respectively indicated:

    • 2.50 percent of manganese, or • 3.30 percent of silicon, or • 1.50 percent of copper, or • 1.50 percent of aluminum, or • 1.25 percent of chromium, or • 0.30 percent of cobalt, or • 0.40 percent of lead, or • 2.0 percent of nickel, or • 0.30 percent of tungsten, or • 0.80 percent of molybdenum, or • 0.10 percent of niobium (also called columbium), or • 0.30 percent of vanadium, or • 0.30 percent of zirconium.

    The subject merchandise is currently provided for in item 7306.61.1000 of the Harmonized Tariff Schedule of the United States (HTSUS). Subject merchandise may also enter under HTSUS 7306.61.3000. While the HTSUS subheadings and ASTM specification are provided for convenience and customs purposes, the written description of the scope of this order is dispositive.

    Changes Since the Preliminary Results

    As no parties submitted comments on the Preliminary Results, we made no changes in the final results of this review.

    Final Results of Administrative Review

    In accordance with section 777A(e)(1) of the Act and 19 CFR 351.221(b)(5), we determine the following countervailable subsidy rate during the period December 28, 2015, through April 25, 2016, and September 12, 2016, through December 31, 2016: 3

    3 As we have made no changes to this rate since the Preliminary Results, no additional disclosure of calculations under 19 CFR 351.224(b) is necessary for these final results.

    Company Subsidy
  • rate
  • (percent)
  • Ozdemir Boru Profil San. Ve Tic. Ltd. Sti 1.18
    Assessment Rates

    In accordance with 19 CFR 351.212(b)(2), Commerce shall determine, and U.S. Customs and Border Protection (CBP) shall assess, countervailing duties on all appropriate entries covered by this review. We intend to issue assessment instructions to CBP 15 days after the date of publication of the final results of this review.

    Cash Deposit Requirement

    Pursuant to section 751(a)(2)(C) of the Act, Commerce also intends to instruct CBP to collect cash deposits of estimated countervailing duties, in the amount shown above, on shipments of subject merchandise by Ozdemir entered, or withdrawn from warehouse, for consumption on or after the date of publication of these final results. For all non-reviewed firms, we will instruct CBP to continue to collect cash deposits at the most-recent company-specific or all-others rate applicable to the company, as appropriate. These cash deposit requirements, when imposed, shall remain in effect until further notice.

    Administrative Protective Order

    This notice also serves as a final reminder to parties subject to an administrative protective order (APO) of their responsibility concerning the return or destruction of proprietary information disclosed under APO in accordance with 19 CFR 351.305(a)(3), which continues to govern business proprietary information in this segment of proceeding. Timely written notification of the return/destruction of APO materials or conversion to judicial protective order is hereby requested. Failure to comply with the regulations and terms of an APO is a violation which is subject to sanction.

    Notification to Interested Parties

    These final results are issued and published in accordance with sections 751(a)(1) and 777(i)(1) of the Act and 19 CFR 351.221(b)(5).

    Dated: November 15, 2018. Gary Taverman, Deputy Assistant Secretary for Antidumping and Countervailing Duty Operations, performing the non-exclusive functions and duties of the Assistant Secretary for Enforcement and Compliance.
    [FR Doc. 2018-25381 Filed 11-20-18; 8:45 am] BILLING CODE 3510-DS-P
    DEPARTMENT OF COMMERCE International Trade Administration Request for Comments and Notice of Roundtable on Energy, Information and Communication Technology, and Infrastructure in the Indo-Pacific Region AGENCY:

    Global Markets, International Trade Administration, U.S. Department of Commerce.

    ACTION:

    Request for public comments and notice of a roundtable discussion on energy, information and communication technology (ICT), and infrastructure in the Indo-Pacific region.

    SUMMARY:

    As part of the commitment to a free and open Indo-Pacific, the Global Markets unit of the International Trade Administration of the Department of Commerce (GM) seeks individual comments from industry on government programs to inform the catalyzation of U.S. private sector participation in commercial opportunities in the Indo-Pacific region in energy, ICT and infrastructure. Through this notice, GM announces a request for written public comments and announces a roundtable to facilitate a discussion with industry representatives and U.S. government staff. This notice serves as an initial step in improving GM's understanding of private sector interests and programmatic and policy needs in energy, ICT, and infrastructure sectors in the Indo-Pacific region. This notice further sets forth topics for discussion and comment.

    DATES:

    Event: The roundtable will be held on December 12, 2018, from 9:00 a.m. to 12:00 p.m., Eastern Standard Time.

    Written Comments: To be ensured of consideration, written public comments must be received on or before January 4, 2019. Comments should not include any business confidential information.

    Event Registration: GM will evaluate registrations based on the submitted information (see below) and inform applicants of selection decisions, which will be made on a rolling basis until 15 participants have been selected for each breakout session.

    ADDRESSES:

    Event: The roundtable will be held at the Department of Commerce, Room 1414, 1401 Constitution Ave. NW, Washington, DC 20230.

    Comments: Written comments should be sent by electronic mail addressed to [email protected]. Comments may also be submitted by mail addressed to: Deputy Assistant Secretary for Asia, International Trade Administration, U.S. Department of Commerce, 1401 Constitution Ave. NW, Room 2846, Washington, DC. Although comments may be submitted by mail, the GM prefers to receive comments via the internet.

    For alternatives to online or mail submissions, please contact Stephanie Smedile, Indo-Pacific Commercial Coordinator, GM, at (202) 482-0333.

    FOR FURTHER INFORMATION CONTACT:

    [email protected] or Stephanie Smedile, Indo-Pacific Commercial Coordinator, GM, at (202) 482-0333

    SUPPLEMENTARY INFORMATION:

    On July 30, 2018 the Trump Administration announced new economic initiatives in the Indo-Pacific region to advance a free and open Indo-Pacific region (See, https://www.whitehouse.gov/briefings-statements/president-donald-j-trumps-administration-advancing-free-open-indo-pacific/). This request for comment and event notification seeks public comment on priorities and strategies to enhance commercial engagement in each of the three initiatives announced. The initiatives and topics for public comment are as follows:

    (1) Digital Connectivity and Cybersecurity Partnership (DCCP)—a new global initiative to promote access to an open, interoperable, reliable, and secure internet, with an initial focus on the Indo-Pacific region. Through this program, the United States will support communications infrastructure development through public-private partnerships, promote regulatory and policy reforms, promote exports of U.S. information and communications technology (ICT) goods and services, and build the cybersecurity capacity of our partners to address shared threats.

    (2) Infrastructure Transaction and Assistance Network (ITAN)—The ITAN will prioritize support for strategically important infrastructure and catalyze opportunities for U.S. business; establish a new Indo-Pacific Transaction Advisory Fund to provide independent legal support for negotiations; and coordinate capacity-building programs to improve partner countries' project evaluation processes, regulatory and procurement environments, and project preparation and financing capabilities.

    (3) Enhancing Development and Growth through Energy, or Asia EDGE, is a U.S. whole of government effort to grow sustainable and secure energy markets throughout the Indo-Pacific. Asia EDGE seeks to strengthen energy security, increase energy diversification and trade, and expand energy access across the Indo-Pacific.

    The Department seeks input at the December 12th roundtable on the following topics:

    • What are the principal U.S. and/or foreign policy and regulatory barriers to growing sales and exports to the Indo-Pacific region? How would you prioritize these barriers for USG engagement?

    • What are the principal barriers (U.S. and/or foreign) to investment in infrastructure (ICT networks, energy, transportation, other) in countries in the Indo-Pacific?

    • Have you worked with USG agencies—such as State, Commerce, USTDA, EXIM, OPIC, USAID—in doing business in the Indo-Pacific? What is your assessment of the strengths and weaknesses of the U.S. government tools to promote U.S. businesses in this sector?

    • What proactive solutions or actions could the U.S. government pursue that would have an impact on catalyzing U.S. private sector participation in commercial opportunities in the Indo-Pacific region?

    Event: The December 12 roundtable hosted by the Deputy Assistant Secretary for Asia will provide an overview of the President's vision for the Indo-Pacific region and will include three break-out sessions—one for each initiative—during which participants will provide insights and feedback related to the energy, ICT, and infrastructure sectors in the Indo-Pacific region. Due to limited space, the event is closed to press and observers. Industry participation is limited to 15 qualifying industry representatives per break-out session (energy, ICT, and infrastructure).

    Selection

    To attend, participants should submit the below information to [email protected] by December 5, 2018. GM will evaluate registrations based on the submitted information on a rolling basis until 15 participants have been selected for each break-out session and inform applicants of selection decisions.

    Applicants are encouraged to send representatives at a sufficiently senior level to be knowledgeable about their organization's capabilities, interests and challenges in the Indo-Pacific region. Please see the following hyperlink for a definition of the Indo-Pacific region: http://www.pacom.mil/About-USINDOPACOM/USPACOM-Area-of-Responsibility/.

    Registrations should include the following information in their registration email:

    • Name of attendee and short bio.

    • Organization and brief organization description.

    • The initiative discussion in which the registrant prefers to participate (DCCP, ITAN, or Asia EDGE). Registrants cannot register for all three as the break-outs happen concurrently. Registrants may indicate a second choice if the preferred choice is filled.

    • A statement self-certifying how the organization meets each of the following criteria:

    1. Is not majority owned or controlled by a foreign government entity (or foreign government entities).

    2. Its existing products or services are either produced in the United States, or, if not, marketed under the name of a U.S. firm and have demonstrable U.S. content as a percentage of the value of the finished product or service AND/OR it is a major investor in projects in the Indo-Pacific in which companies with such products may compete.

    3. It has already exported from the United States to or invested in the Indo-Pacific region.

    4. In the case of a trade association, academic or research institution, the applicant will only be representing companies during the Roundtable that satisfy each of the criteria above.

    Selection will be based on the following criteria:

    • Suitability of the company's (or in the case of another organization, represented companies' or constituents') existing products or services to energy, ICT, and infrastructure commercial opportunities in the Indo-Pacific.

    • Suitability of the company's (or in the case of another organization, represented companies' or constituents') experience pursuing commercial opportunities in the Indo-Pacific.

    • Suitability of the representative's position and biography to be able to engage in the conversation.

    Anthony Diaz, Program Analyst, SelectUSA, International Trade Administration, U.S. Department of Commerce.
    [FR Doc. 2018-25417 Filed 11-20-18; 8:45 am] BILLING CODE 3510-FP-P
    DEPARTMENT OF COMMERCE National Oceanic and Atmospheric Administration Submission for OMB Review; Comment Request

    The Department of Commerce will submit to the Office of Management and Budget (OMB) for clearance the following proposal for collection of information under the provisions of the Paperwork Reduction Act (44 U.S.C. Chapter 35).

    Agency: National Oceanic and Atmospheric Administration (NOAA).

    Title: Submission of Conservation Efforts to Make Listings Unnecessary Under the Endangered Species Act.

    OMB Control Number: 0648-0466.

    Form Number(s): None.

    Type of Request: Regular (extension of a currently approved information collection).

    Number of Respondents: 1.

    Average Hours per Response: 2,500 hours to complete each agreement or plan that has the intention of making listing unnecessary; 320 hours to conduct monitoring for successful agreements; and 80 hours to prepare a report for successful agreements.

    Burden Hours: 2,900.

    Needs and Uses: This request is for extension of a currently approved information collection.

    On March 28, 2003, the National Marine Fisheries Service (NMFS) and the U.S. Fish and Wildlife Service (Services) announced a final policy on the criteria the Services will use to evaluate conservation efforts by states and other non-Federal entities (68 FR 15100). The Services take these efforts into account when making decisions on whether to list a species as threatened or endangered under the Endangered Species Act. The efforts usually involve the development of a conservation plan or agreement, procedures for monitoring the effectiveness of the plan or agreement, and an annual report.

    Affected Public: Business or other for-profit organizations; State, local or tribal governments.

    Frequency: Annually and on occasion.

    Respondent's Obligation: Voluntary.

    This information collection request may be viewed at reginfo.gov. Follow the instructions to view Department of Commerce collections currently under review by OMB.

    Written comments and recommendations for the proposed information collection should be sent within 30 days of publication of this notice to [email protected] or fax to (202) 395-5806.

    Dated: November 16, 2018. Sarah Brabson, NOAA PRA Clearance Officer.
    [FR Doc. 2018-25368 Filed 11-20-18; 8:45 am] BILLING CODE 3510-22-P
    DEPARTMENT OF COMMERCE United States Patent and Trademark Office Submission for OMB Review; Comment Request; “Patents for Humanity Program”

    The United States Patent and Trademark Office (USPTO) will submit to the Office of Management and Budget (OMB) for clearance the following proposal for collection of information under the provisions of the Paperwork Reduction Act (44 U.S.C. Chapter 35).

    Agency: United States Patent and Trademark Office, Commerce.

    Title: Patents for Humanity Program.

    OMB Control Number: 0651-0066.

    Form Number(s):

    • PTO/PFH/001 • PTO/PFH/002 • PTO/SB/431

    Type of Request: Regular.

    Number of Respondents: 55 responses per year.

    Average Hours per Response: The USPTO estimates that it will take the public approximately four hours to complete the humanitarian program application. Those selected as winners (about 5 to 10 per year) may additionally require one hour to complete a petition to extend their acceleration certificate redemption beyond 12 months, if needed. These estimated times include gathering the necessary information, preparing the application and any supplemental materials, and submitting the completed request to USPTO.

    Burden Hours: 205 hours per year.

    Cost Burden: $0 per year.

    Needs and Uses: The USPTO has developed two application forms that applicants can use to apply for participation in the Patents for Humanity Program. One application covers the humanitarian uses of technologies or products and the other application covers humanitarian research. In addition, there is a form that allows applicants to provide their contact information which the USPTO uses to notify applicants that they have been selected for an award. These applications may be up to five pages long and can be supplemented with additional supporting materials. The applications must be submitted electronically through the competition website.

    Applicants who are ultimately awarded a Humanitarian Award Certificate may wish to extend the redemption period of that certificate. In the event that an applicant wishes to extend that time period, they must complete a Petition to Extend the Redemption Period of the Humanitarian Awards Certificate. The petition is a one-page document which allows the applicant to request a 12-month extension of their certificate's redemption period based on criteria outlined on the form (e.g., lack of a suitable matter, a pending matter is not yet ripe for certificate redemption, etc.).

    Affected Public: Businesses or other for-profits; not-for-profit institutions.

    Frequency: On occasion.

    Respondent's Obligation: Required to Obtain or Retain Benefits.

    OMB Desk Officer: Nicholas A. Fraser, email: [email protected].

    Once submitted, the request will be publically available in electronic format through www.reginfo.gov. Follow the instructions to view Department of Commerce collections currently under review by OMB.

    Further information can be obtained by:

    Email: [email protected]. Include “0651-0066 copy request” in the subject line of the message.

    Mail: Marcie Lovett, Records and Information Governance Division Director, Office of the Chief Administrative Officer, United States Patent and Trademark Office, P.O. Box 1450, Alexandria, VA 22313-1450.

    Written comments and recommendations for the proposed information collection should be sent on or before December 21, 2018 to Nicholas A. Fraser, OMB Desk Officer, via email to [email protected], or by fax to 202-395-5167, marked to the attention of Nicholas A. Fraser.

    Marcie Lovett, Records Management Division Director, USPTO, Office of the Chief Administrative Officer.
    [FR Doc. 2018-25410 Filed 11-20-18; 8:45 am] BILLING CODE 3510-16-P
    DEPARTMENT OF COMMERCE United States Patent and Trademark Office Submission for OMB Review; Comment Request; “Patent Review and Derivation Proceedings”

    The United States Patent and Trademark Office (USPTO) will submit to the Office of Management and Budget (OMB) for clearance the following proposal for collection of information under the provisions of the Paperwork Reduction Act (44 U.S.C. Chapter 35).

    Agency: United States Patent and Trademark Office, Commerce

    Title: Patent Review and Derivation Proceedings.

    Form Number(s): N/A.

    Type of Request: Regular.

    Number of Respondents: 11.994 responses per year.

    Average Hours per Response: The USPTO estimates that it will take the public between an estimated 6 minutes (0.10 hours) to 165.30 hours to complete an individual form in this collection.

    Burden Hours: 1,474,449 hours.

    Cost Burden: $54,307,175 per year.

    Needs and Uses: The public will use this information collection to petition the Board to seek the institution of—and to participate in—inter partes reviews, post-grant reviews, covered business method patent reviews, and derivation proceedings.

    The Board disseminated information that it collections (unless filed under seal) through various publications and databases. This information collection includes the filings of the parties and decisions and orders by the Board in trials and derivation proceedings.

    Opinions authored by the Board have varying degrees of authority attached to them. There are precedential opinions which, when published, are binding and provide the criteria and authority that the Board will use to decide all other factually similar cases (until the opinion is overruled or changed by statute). There are informative opinions, which are non-precedential and illustrate the norms of Board decision-making for the public. There are representative opinions, which are non-precedential and are publicly available opinions that are not designed as precedential or informative. Since public policy favors a widespread publication of opinions, the Board publishes all publicly available opinions, even if the opinions are not binding precedent upon the Board.

    Affected Public: Businesses or other for-profits; not-for-profit institutions.

    Frequency: On occasion.

    Respondent's Obligation: Required to Obtain or Retain Benefits.

    OMB Desk Officer: Nicholas A. Fraser, email: [email protected].

    Once submitted, the request will be publically available in electronic format through www.reginfo.gov. Follow the instructions to view Department of Commerce collections currently under review by OMB.

    Further information can be obtained by:

    Email: [email protected]. Include “0651-0069 copy request” in the subject line of the message.

    Mail: Marcie Lovett, Records and Information Governance Division Director, Office of the Chief Administrative Officer, United States Patent and Trademark Office, P.O. Box 1450, Alexandria, VA 22313-1450.

    Written comments and recommendations for the proposed information collection should be sent on or before December 21, 2018 to Nicholas A. Fraser, OMB Desk Officer, via email to [email protected], or by fax to 202-395-5167, marked to the attention of Nicholas A. Fraser.

    Marcie Lovett, Records Management Division Director, USPTO, Office of the Chief Administrative Officer.
    [FR Doc. 2018-25409 Filed 11-20-18; 8:45 am] BILLING CODE 3510-16-P
    DEPARTMENT OF COMMERCE United States Patent and Trademark Office Submission for OMB Review; Comment Request; “Matters Related to First Inventor to File”

    The Department of Commerce will submit to the Office of Management and Budget (OMB) for clearance the following proposal for collection of information under the provisions of the Paperwork Reduction Act.

    Agency: United States Patent and Trademark Office, Commerce.

    Title: Matters Related to First Inventor to File.

    OMB Control Number: 0651-0071.

    Form Number(s): None.

    Type of Request: Regular.

    Number of Respondents: 23,681 responses per year.

    Average Time per Response: The USPTO expects that it will take between 2 and 10 hours to respond to the items in this collection, depending upon the instrument used. This includes the time to gather the necessary information, create the document, and submit the completed request to the USPTO.

    Burden Hours: 207,362 hours per year.

    Cost Burden: $80.40 per year.

    Needs and Uses: This information collection is necessary so that patent applicants and/or patentees may: (1) Provide a statement if a nonprovisional application filed on or after March 16, 2013, other than a nonprovisional international design application, claims the benefit of, or priority to, the filing date of a foreign, provisional, or nonprovisional application filed prior to March 16, 2013, and also contains, or contained at any time, a claim to a claimed invention that has an effective filing date (as defined in 37 CFR 1.109) on or after March 16, 2013; (2) identify the inventorship and ownership or obligation to assign ownership of each claimed invention on its effective filing date (as defined in 37 CFR 1.109) or on its date of invention, as applicable, in an application or patent naming one or more joint inventors, when necessary for purposes of a USPTO proceeding; and (3) show that a disclosure was by the inventor or joint inventor, or was by a party who obtained the subject matter from the inventor or a joint inventor, or that there was a prior public disclosure by the inventor or a joint inventor, or by a party who obtained the subject matter from the inventor or a joint inventor.

    The USPTO will use the statement that a nonprovisional application filed on or after March 16, 2013, other than a nonprovisional international design application, that claims the benefit of, or priority to, the filing date of a foreign, provisional, or nonprovisional application filed prior to March 16, 2013, and contains, or contained at any time, a claim to a claimed invention that has an effective filing date (as defined in 37 CFR 1.109) on or after March 16, 2013, (or lack of such a statement) to readily determine whether the nonprovisional application is subject to the changes to 35 U.S.C. 102 and 103 in the AIA. The USPTO will use the identification of the inventorship and ownership or obligation to assign ownership when it is necessary to determine whether a U.S. patent or U.S. patent application publication resulting from another nonprovisional application qualifies as prior art under 35 U.S.C. 102(a)(2) or pre-AIA 35 U.S.C. 102(e). The USPTO will use information concerning whether a disclosure was by the inventor or joint inventor, or was by a party who obtained the subject matter from the inventor or a joint inventor, or that there was a prior public disclosure by the inventor or a joint inventor, or by a party who obtained the subject matter from the inventor or a joint inventor, to determine whether the disclosure qualifies as prior art under 35 U.S.C. 102(a)(1) or (a)(2).

    Affected Public: Businesses or other for-profits; not-for-profit institutions.

    Frequency: On occasion.

    Respondent's Obligation: Required to obtain or retain benefits.

    OMB Desk Officer: Nicholas A. Fraser, email: [email protected].

    Once submitted, the request will be publicly available in electronic format through reginfo.gov. Follow the instructions to view Department of Commerce collections currently under review by OMB.

    Further information can be obtained by:

    Email: [email protected]. Include “0651-0071 copy request” in the subject line of the message.

    Mail: Marcie Lovett, Director, Records and Information Goverance Division, Office of the Chief Administrative Officer, United States Patent and Trademark Office, P.O. Box 1450, Alexandria, VA 22313-1450.

    Written comments and recommendations for the proposed information collection should be sent on or before December 21, 2018 to Nicholas A. Fraser, OMB Desk Officer, via email to [email protected], or by fax to 202 395-5167, marked to the attention of Nicholas A. Fraser.

    Marcie Lovett, Director, Records and Information Governance Division, Office of the Chief Adiminstrative Officer, USPTO.
    [FR Doc. 2018-25408 Filed 11-20-18; 8:45 am] BILLING CODE 350-16-P
    BUREAU OF CONSUMER FINANCIAL PROTECTION Credit Union Advisory Council Meeting AGENCY:

    Bureau of Consumer Financial Protection.

    ACTION:

    Notice of public meeting.

    SUMMARY:

    Under the Federal Advisory Committee Act (FACA), this notice sets forth the announcement of a public meeting of the Credit Union Advisory Council (CUAC or Council) of the Bureau of Consumer Financial Protection (Bureau). The notice also describes the functions of the Council.

    DATES:

    The meeting date is Thursday, December 6, 2018, from approximately 1 p.m. to 3:45 p.m. eastern daylight time. The meeting will take place via conference call.

    Access: The subcommittee meetings will be conducted via conference call and are open to the general public. Members of the public will receive the agenda and dial-in information when they RSVP.

    FOR FURTHER INFORMATION CONTACT:

    Crystal Dully, Outreach and Engagement Associate, Consumer Advisory Board and Councils Office, External Affairs, at 202-435-9588, [email protected]. If you require this document in an alternative electronic format, please contact [email protected].

    SUPPLEMENTARY INFORMATION: I. Background

    Section 2 of the CUAC Charter provides that pursuant to the executive and administrative powers conferred on the Bureau of Consumer Financial Protection by section 1012 of the Dodd-Frank Wall Street Reform and Consumer Protection Act (Dodd-Frank Act), the Director established the Credit Union Advisory Council under agency authority.

    Section 3 of the CUAC Charter states: “The purpose of the Advisory Council is to advise the Bureau in the exercise of its functions under the federal consumer financial laws as they pertain to community banks with total assets of $10 billion or less.”

    II. Agenda

    The Credit Union Advisory Council will discuss artificial intelligence in consumer financial services and consumer access to financial records.

    Persons who need a reasonable accommodation to participate should contact [email protected], 202-435-9EEO, 1-855-233-0362, or 202-435-9742 (TTY) at least ten business days prior to the meeting or event to request assistance. The request must identify the date, time, location, and title of the meeting or event, the nature of the assistance requested, and contact information for the requester. CFPB will strive to provide, but cannot guarantee that accommodation will be provided for late requests.

    Written comments will be accepted from interested members of the public and should be sent to [email protected], a minimum of seven (7) days in advance of the meeting. The comments will be provided to the CUAC members for consideration.

    Individuals who wish to join the Credit Union Advisory Council must RSVP via this link https://consumer-financial-protection-bureau.forms.fm/bcfp-advisory-board-and-councils-december-conference-call by noon, December 5, 2018. Members of the public must RSVP by the due date.

    III. Availability

    The Council's agenda will be made available to the public on Wednesday November 21, 2018, via consumerfinance.gov. A summary of this meeting will be available after the meeting on the Bureau's website consumerfinance.gov.

    Dated: November 16, 2018. Kirsten Sutton, Chief of Staff, Bureau of Consumer Financial Protection.
    [FR Doc. 2018-25419 Filed 11-20-18; 8:45 am] BILLING CODE 4810-AM-P
    BUREAU OF CONSUMER FINANCIAL PROTECTION Community Bank Advisory Council Meeting AGENCY:

    Bureau of Consumer Financial Protection.

    ACTION:

    Notice of public meeting.

    SUMMARY:

    Under the Federal Advisory Committee Act (FACA), this notice sets forth the announcement of a public meeting of the Community Bank Advisory Council (CBAC or Council) of the Bureau of Consumer Financial Protection (Bureau). The notice also describes the functions of the Council.

    DATES:

    The meeting date is Thursday, December 6, 2018, from approximately 1 p.m. to 3:45 p.m. eastern daylight time. The meeting will take place via conference call.

    Access: The subcommittee meetings will be conducted via conference call and are open to the general public. Members of the public will receive the agenda and dial-in information when they RSVP.

    FOR FURTHER INFORMATION CONTACT:

    Crystal Dully, Outreach and Engagement Associate, Consumer Advisory Board and Councils Office, External Affairs, at 202-435-9588, [email protected]. If you require this document in an alternative electronic format, please contact [email protected].

    SUPPLEMENTARY INFORMATION: I. Background

    Section 2 of the CBAC Charter provides that pursuant to the executive and administrative powers conferred on the Bureau of Consumer Financial Protection by section 1012 of the Dodd-Frank Wall Street Reform and Consumer Protection Act (Dodd-Frank Act), the Director established the Community Bank Advisory Council under agency authority.

    Section 3 of the CBAC Charter states: “The purpose of the Advisory Council is to advise the Bureau in the exercise of its functions under the federal consumer financial laws as they pertain to community banks with total assets of $10 billion or less.”

    II. Agenda

    The Community Bank Advisory Council will discuss artificial intelligence in consumer financial services and consumer access to financial records.

    Persons who need a reasonable accommodation to participate should contact [email protected], 202-435-9EEO, 1-855-233-0362, or 202-435-9742 (TTY) at least ten business days prior to the meeting or event to request assistance. The request must identify the date, time, location, and title of the meeting or event, the nature of the assistance requested, and contact information for the requester. CFPB will strive to provide, but cannot guarantee that accommodation will be provided for late requests.

    Written comments will be accepted from interested members of the public and should be sent to [email protected], a minimum of seven (7) days in advance of the meeting. The comments will be provided to the CBAC members for consideration.

    Individuals who wish to join the Community Bank Advisory Council must RSVP via this link https://consumer-financial-protection-bureau.forms.fm/bcfp-advisory-board-and-councils-december-conference-call by noon, December 5, 2018. Members of the public must RSVP by the due date.

    III. Availability

    The Council's agenda will be made available to the public on Wednesday November 21, 2018, via consumerfinance.gov. A summary of this meeting will be available after the meeting on the Bureau's website consumerfinance.gov.

    Dated: November 16, 2018. Kirsten Sutton, Chief of Staff, Bureau of Consumer Financial Protection.
    [FR Doc. 2018-25421 Filed 11-20-18; 8:45 am] BILLING CODE 4810-AM-P
    BUREAU OF CONSUMER FINANCIAL PROTECTION Consumer Advisory Board Subcommittee Meetings AGENCY:

    Bureau of Consumer Financial Protection.

    ACTION:

    Notice of public meeting.

    SUMMARY:

    Under the Federal Advisory Committee Act (FACA), this notice sets forth the announcement of a public meeting of the Consumer Advisory Board (CAB or Board) of the Bureau of Consumer Financial Protection (Bureau). The notice also describes the functions of the Board.

    DATES:

    The meeting date is Thursday, December 6, 2018, from approximately 1 p.m. to 3:45 p.m. eastern daylight time. The meeting will take place via conference call.

    Access: The subcommittee meetings will be conducted via conference call and are open to the general public. Members of the public will receive the agenda and dial-in information when they RSVP.

    FOR FURTHER INFORMATION CONTACT:

    Crystal Dully, Outreach and Engagement Associate, Advisory Board and Councils Office, External Affairs, at 202-435-9588, [email protected]. If you require this document in an alternative electronic format, please contact [email protected].

    SUPPLEMENTARY INFORMATION: I. Background

    Section 3 of the Charter of the Consumer Advisory Board states that:

    The purpose of the Board is outlined in section 1014(a) of the Dodd-Frank Act, which states that the Board shall “advise and consult with the Bureau in the exercise of its functions under the Federal consumer financial laws” and “provide information on emerging practices in the consumer financial products or services industry, including regional trends, concerns, and other relevant information.”

    To carry out the Board's purpose, the scope of its activities shall include providing information, analysis, and recommendations to the Bureau. The Board will generally serve as a vehicle for market intelligence and expertise for the Bureau. Its objectives will include identifying and assessing the impact on consumers and other market participants of new, emerging, and changing products, practices, or services.

    II. Agenda

    The Consumer Advisory Board will discuss artificial intelligence in consumer financial services and consumer access to financial records.

    Persons who need a reasonable accommodation to participate should contact [email protected], 202-435-9EEO, 1-855-233-0362, or 202-435-9742 (TTY) at least ten business days prior to the meeting or event to request assistance. The request must identify the date, time, location, and title of the meeting or event, the nature of the assistance requested, and contact information for the requester. CFPB will strive to provide, but cannot guarantee that accommodation will be provided for late requests.

    Written comments will be accepted from interested members of the public and should be sent to [email protected], a minimum of seven (7) days in advance of the meeting. The comments will be provided to the CAB members for consideration. Individuals who wish to join the Consumer Advisory Board must RSVP via this link https://consumer-financial-protection-bureau.forms.fm/bcfp-advisory-board-and-councils-december-conference-call by noon, December 5, 2018. Members of the public must RSVP by the due date.

    III. Availability

    The Board's agenda will be made available to the public on Wednesday November 21, 2018, via consumerfinance.gov. A summary of this meeting will be available after the meeting on the Bureau's website consumerfinance.gov.

    Dated: November 16, 2018. Kirsten Sutton, Chief of Staff, Bureau of Consumer Financial Protection.
    [FR Doc. 2018-25420 Filed 11-20-18; 8:45 am] BILLING CODE 4810-AM-P
    CORPORATION FOR NATIONAL AND COMMUNITY SERVICE Agency Information Collection Activities; Submission to the Office of Management and Budget for Review and Approval; Comment Request; National Service Criminal History Check Recordkeeping Requirement AGENCY:

    Corporation for National and Community Service (CNCS).

    ACTION:

    Notice of Information Collection; request for comment.

    SUMMARY:

    In accordance with the Paperwork Reduction Act of 1995, CNCS is proposing to renew an information collection related to the National Service Criminal History Check.

    DATES:

    Written comments must be submitted to the individual and office listed in the ADDRESSES section by January 22, 2019.

    ADDRESSES:

    You may submit comments, identified by the title of the information collection activity, by any of the following methods:

    (1) By mail sent to: Corporation for National and Community Service, Attention Aaron Olszewski, 250 E Street SW, Washington, DC 20525.

    (2) By hand delivery or by courier to the CNCS mailroom at the mail address given in paragraph (1) above, between 9:00 a.m. and 4:00 p.m. Eastern Time, Monday through Friday, except federal holidays.

    (3) Electronically through www.regulations.gov.

    Individuals who use a telecommunications device for the deaf (TTY-TDD) may call 1-800-833-3722 between 8:00 a.m. and 8:00 p.m. Eastern Time, Monday through Friday.

    Comments submitted in response to this notice may be made available to the public through regulations.gov. For this reason, please do not include in your comments information of a confidential nature, such as sensitive personal information or proprietary information. If you send an email comment, your email address will be automatically captured and included as part of the comment that is placed in the public docket and made available on the internet. Please note that responses to this public comment request containing any routine notice about the confidentiality of the communication will be treated as public comment that may be made available to the public, notwithstanding the inclusion of the routine notice.

    FOR FURTHER INFORMATION CONTACT:

    Aaron Olszewski, 202-606-6670, or by email at [email protected].

    SUPPLEMENTARY INFORMATION:

    Title of Collection: National Service Criminal History Check Recordkeeping.

    OMB Control Number: 3045-0145.

    Type of Review: Renewal.

    Respondents/Affected Public: Non Profit Organizations and State, Local or Tribal Governments.

    Total Estimated Number of Annual Responses: 112,357.

    Total Estimated Number of Annual Burden Hours: 28,089.

    Abstract: Section 189D of the National and Community Service Act of 1990, as amended requires CNCS grantees and subgrantees to conduct a National Service Criminal History Check on individuals in covered positions. Documenting compliance with the requirement is critical to that responsibility. See 45 CFR 2540.205-.206. CNCS also seeks to continue using the currently approved information collection until the revised information collection is approved by OMB. The currently approved information collection is due to expire on May 31, 2019.

    Comments submitted in response to this notice will be summarized and/or included in the request for OMB approval. Comments are invited on: (a) Whether the collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility; (b) the accuracy of the agency's estimate of the burden of the collection of information; (c) ways to enhance the quality, utility, and clarity of the information to be collected; (d) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or other forms of information technology; and (e) estimates of capital or start-up costs and costs of operation, maintenance, and purchase of services to provide information. Burden means the total time, effort, or financial resources expended by persons to generate, maintain, retain, disclose or provide information to or for a Federal agency. This includes the time needed to review instructions; to develop, acquire, install and utilize technology and systems for the purpose of collecting, validating and verifying information, processing and maintaining information, and disclosing and providing information; to train personnel and to be able to respond to a collection of information, to search data sources, to complete and review the collection of information; and to transmit or otherwise disclose the information. All written comments will be available for public inspection on regulations.gov.

    Dated: November 16, 2018. Aaron Olszewski, Associate General Counsel.
    [FR Doc. 2018-25414 Filed 11-20-18; 8:45 am] BILLING CODE 6050-28-P
    DEPARTMENT OF DEFENSE Office of the Secretary [Docket ID: DOD-2018-OS-0091] Proposed Collection; Comment Request AGENCY:

    Office of the Under Secretary of Defense for Personnel and Readiness (OUSD (P&R)), Federal Voting Assistance Program (FVAP), DoD.

    ACTION:

    Information collection notice.

    SUMMARY:

    In compliance with the Paperwork Reduction Act of 1995, the Office of the Under Secretary of Defense for Personnel and Readiness announces a proposed public information collection and seeks public comment on the provisions thereof. Comments are invited on: whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility; the accuracy of the agency's estimate of the burden of the proposed information collection; ways to enhance the quality, utility, and clarity of the information to be collected; and ways to minimize the burden of the information collection on respondents, including through the use of automated collection techniques or other forms of information technology.

    DATES:

    Consideration will be given to all comments received by January 22, 2019.

    ADDRESSES:

    You may submit comments, identified by docket number and title, by any of the following methods:

    Federal eRulemaking Portal: http://www.regulations.gov. Follow the instructions for submitting comments.

    Mail: Department of Defense, Office of the Chief Management Officer, Directorate for Oversight and Compliance, 4800 Mark Center Drive, Mailbox #24 Suite 08D09, Alexandria, VA 22350-1700.

    Instructions: All submissions received must include the agency name, docket number and title for this Federal Register document. The general policy for comments and other submissions from members of the public is to make these submissions available for public viewing on the internet at http://www.regulations.gov as they are received without change, including any personal identifiers or contact information.

    FOR FURTHER INFORMATION CONTACT:

    To request more information on this proposed information collection or to obtain a copy of the proposal and associated collection instruments, please write to the Federal Voting Assistance Program, ATTN: Sarah Gooch, 4800 Mark Center Drive, Mailbox 10, Alexandria, VA 22350-5000 or call 703-588-1584.

    SUPPLEMENTARY INFORMATION:

    Title; Associated Form; and OMB Number: Federal Write-In Absentee Ballot (FWAB); Standard Form 186; OMB Control Number 0704-0502.

    Needs and Uses: The Uniformed and Overseas Citizens Absentee Voting Act (UOCAVA), 52 U.S.C. 203, requires the Presidential designee (Secretary of Defense) to prescribe official forms, containing an absentee voter registration application, an absentee ballot request application and a backup ballot for use by the States to permit absent uniformed services voters and overseas voters to participate in general, special, primary and runoff elections for Federal office.

    Affected Public: Individuals or Households.

    Annual Burden Hours: 300,000.

    Number of Respondents: 1,200,000.

    Responses per Respondent: 1.

    Annual Responses: 1,200,000.

    Average Burden per Response: 15 minutes.

    Frequency: On occasion.

    The authority for the States to collect personal information comes from UOCAVA. The burden for collecting this information resides in the States. The Federal government neither collects nor retains any personal information associated with these forms. The collected information will be used by election officials to process uniformed service members, spouses and overseas citizens who submit their information to register to vote, receive an absentee ballot or cast a write-in ballot. The collected information will be retained by election officials to provide election materials, including absentee ballots, to the uniformed services, their eligible family members and overseas voters during the form's eligibility period provided by State law. No information from the Federal Write-In Absentee Ballot (FWAB) is collected or retained by the Federal government. The applicant is required to update and resubmit the information annually, whenever they change their mailing address or as otherwise required by State law. If the information is not submitted annually or whenever they change their mailing address, the applicant may not receive ballots for elections for Federal office in that calendar year.

    Dated: November 16, 2018. Aaron T. Siegel, Alternate OSD Federal Register, Liaison Officer, Department of Defense.
    [FR Doc. 2018-25393 Filed 11-20-18; 8:45 am] BILLING CODE 5001-06-P
    DEPARTMENT OF DEFENSE Office of the Secretary Board of Visitors, National Defense University; Notice of Federal Advisory Committee Meeting AGENCY:

    Office of the Chairman Joint Chiefs of Staff, Department of Defense.

    ACTION:

    Notice of Federal Advisory Committee meeting.

    SUMMARY:

    The Department of Defense (DoD) is publishing this notice to announce that the following Federal Advisory Committee meeting of the Board of Visitors, National Defense University will take place.

    DATES:

    Thursday, December 6, 2018 from 12:30 p.m. to 5:15 p.m. and Friday, December 7, 2018 from 10:30 a.m. to 12:15 p.m.

    ADDRESSES:

    Marshall Hall, Building 62, Room 155A/B (Thursday), Lincoln Hall, Building 64, Room 1107 (Friday), the National Defense University, 300 5th Avenue SW, Fort McNair, Washington, DC 20319-5066.

    FOR FURTHER INFORMATION CONTACT:

    Dr. Brian R. Shaw, (202) 685-4685 (Voice), (202) 685-3920 (Facsimile), [email protected]; [email protected]; [email protected]; [email protected] (Email). Mailing address is National Defense University, Fort McNair, Washington, DC 20319-5066. Website: http://www.ndu.edu/About/Board-of-Visitors/. The most up-to-date changes to the meeting agenda can be found on the website.

    SUPPLEMENTARY INFORMATION:

    This meeting is being held under the provisions of the Federal Advisory Committee Act (FACA) of 1972 (5 U.S.C., Appendix, as amended), the Government in the Sunshine Act of 1976 (5 U.S.C. 552b, as amended), and 41 CFR 102-3.140 and 102-3.150. Pursuant to 5 U.S.C. 552b and 41 CFR 102-3.140 through 102-3.165, and the availability of space, this meeting is open to the public.

    Purpose of the Meeting: The purpose of the meeting will include discussion on accreditation compliance, organizational management, strategic planning, resource management, and other matters of interest to the National Defense University.

    Agenda: Thursday, December 6, 2018 from 12:30 p.m. to 5:15 p.m.: Welcome and Administrative Notes; State of the University Address; Globally Integrated Operations; NDU Strategic Plan; State of the NDU Budget; Information Technology Update; Faculty and Staff Command Climate Survey Results and Analysis. Friday, December 7, 2018 from 10:30 a.m. to 12:15 p.m.: Condition of NDU Facilities; Public Comment, Board of Visitor Member Feedback; Wrap-up and Closing Remarks.

    Meeting Accessibility: Limited space made available for observers will be allocated on a first come, first served basis. Meeting location is handicap accessible. The Main Gate/Visitor's Gate on 2nd Street SW is open 24/7. All non-DoD/non-federally affiliated visitors MUST use this gate to access Fort McNair.

    ID Requirements: A federal or state government-issued photo ID with biographic information such as name, date of birth, gender, and address is required. Security badges are not acceptable. All credentials are subject to screening and vetting by Installation Access Control personnel.

    Vehicle Search: Non-DoD/non-federally affiliated visitors' vehicles are subject to search.

    Written Statements: Pursuant to 41 CFR 102-3.105(j) and 102-3.140, and section 10(a)(3) of the Federal Advisory Committee Act of 1972, written statements to the committee may be submitted to the committee at any time or in response to a stated planned meeting agenda by FAX or email to Ms. Joycelyn Stevens at (202) 685-0079, Fax (202) 685-3920 or [email protected].

    Dated: November 16, 2018. Aaron T. Siegel, Alternate OSD Federal Register Liaison Officer, Department of Defense.
    [FR Doc. 2018-25432 Filed 11-20-18; 8:45 am] BILLING CODE 5001-06-P
    DEPARTMENT OF EDUCATION [Docket No.: ED-2018-ICCD-0123] Agency Information Collection Activities; Comment Request; Performance Partnership Pilots Application AGENCY:

    Office of Career, Technical, and Adult Education (OCTAE), Department of Education (ED).

    ACTION:

    Notice.

    SUMMARY:

    In accordance with the Paperwork Reduction Act of 1995, ED is proposing an extension of an existing information collection.

    DATES:

    Interested persons are invited to submit comments on or before January 22, 2019.

    ADDRESSES:

    To access and review all the documents related to the information collection listed in this notice, please use http://www.regulations.gov by searching the Docket ID number ED-2018-ICCD-0123. Comments submitted in response to this notice should be submitted electronically through the Federal eRulemaking Portal at http://www.regulations.gov by selecting the Docket ID number or via postal mail, commercial delivery, or hand delivery. Please note that comments submitted by fax or email and those submitted after the comment period will not be accepted. Written requests for information or comments submitted by postal mail or delivery should be addressed to the Director of the Information Collection Clearance Division, U.S. Department of Education, 550 12th Street SW, PCP, Room 9088, Washington, DC 20202-0023.

    FOR FURTHER INFORMATION CONTACT:

    For specific questions related to collection activities, please contact Braden Goetz, 202-245-7405.

    SUPPLEMENTARY INFORMATION:

    The Department of Education (ED), in accordance with the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3506(c)(2)(A)), provides the general public and Federal agencies with an opportunity to comment on proposed, revised, and continuing collections of information. This helps the Department assess the impact of its information collection requirements and minimize the public's reporting burden. It also helps the public understand the Department's information collection requirements and provide the requested data in the desired format. ED is soliciting comments on the proposed information collection request (ICR) that is described below. The Department of Education is especially interested in public comment addressing the following issues: (1) Is this collection necessary to the proper functions of the Department; (2) will this information be processed and used in a timely manner; (3) is the estimate of burden accurate; (4) how might the Department enhance the quality, utility, and clarity of the information to be collected; and (5) how might the Department minimize the burden of this collection on the respondents, including through the use of information technology. Please note that written comments received in response to this notice will be considered public records.

    Title of Collection: Performance Partnership Pilots Application.

    OMB Control Number: 1830-0575.

    Type of Review: An extension of an existing information collection.

    Respondents/Affected Public: State, Local, and Tribal Governments.

    Total Estimated Number of Annual Responses: 25.

    Total Estimated Number of Annual Burden Hours: 2,000.

    Abstract: This information collection request solicits applications for the Performance Partnership Pilots for Disconnected Youth, which provides States, localities, or tribal governments receiving funds under multiple Federal programs additional flexibility in using these funds to achieve significant improvement in outcomes for disconnected youth.

    Dated: November 16, 2018. Tomakie Washington, Acting Director, Information Collection Clearance Division, Office of the Chief Privacy Officer, Office of Management.
    [FR Doc. 2018-25404 Filed 11-20-18; 8:45 am] BILLING CODE 4000-01-P
    DEPARTMENT OF ENERGY Fusion Energy Sciences Advisory Committee AGENCY:

    Office of Science, Department of Energy.

    ACTION:

    Notice of open meeting.

    SUMMARY:

    This notice announces a meeting of the Fusion Energy Sciences Advisory Committee. The Federal Advisory Committee Act requires that public notice of these meetings be announced in the Federal Register.

    DATES:

    December 6, 2018—8:30 a.m. to 5:00 p.m.; December 7, 2018—8:30 a.m. to 12:00 noon.

    ADDRESSES:

    Canopy by Hilton, 940 Rose Avenue, North Bethesda, MD 20852.

    FOR FURTHER INFORMATION CONTACT:

    Dr. Samuel J. Barish, Acting Designated Federal Officer, Office of Fusion Energy Sciences (FES); U.S. Department of Energy; Office of Science; 1000 Independence Avenue SW, Washington, DC 20585; Telephone: (301) 903-2917.

    SUPPLEMENTARY INFORMATION:

    Purpose of Meeting: To provide advice on a continuing basis to the Director, Office of Science of the Department of Energy, on the many complex scientific and technical issues that arise in the development and implementation of the fusion energy sciences program.

    Tentative Agenda Items • Under Secretary for Science Perspective • FES Perspective • Approval of the FESAC Committee of Visitors Report • New Long-Range Strategic Planning Activity • Fusion Energy Sciences Roundtable on Quantum Information Science • Public Comment • Adjourn

    Note: Remote attendance of the FESAC meeting will be possible via Zoom. Instructions will be posted on the FESAC website (http://science.energy.gov/fes/fesac/meetings/) prior to the meeting and can also be obtained by contacting Dr. Barish by email [email protected] or by phone at (301) 903-2917.

    Public Participation: The meeting is open to the public. If you would like to file a written statement with the Committee, you may do so either before or after the meeting. If you would like to make an oral statement regarding any of the items on the agenda, you should contact Dr. Barish at (301) 903-1233 (fax) or [email protected] (email). Reasonable provision will be made to include the scheduled oral statements during the Public Comment time on the agenda. The Chairperson of the Committee will conduct the meeting to facilitate the orderly conduct of business. Public comment will follow the 10-minute rule.

    Minutes: The minutes of the meeting will be available for public review and copying within 30 days on the Fusion Energy Sciences Advisory Committee website—http://science.energy.gov/fes/fesac/.

    Signed in Washington, DC, on November 16, 2018. LaTanya Butler, Deputy Committee Management Officer.
    [FR Doc. 2018-25382 Filed 11-20-18; 8:45 am] BILLING CODE 6450-01-P
    DEPARTMENT OF ENERGY Federal Energy Regulatory Commission Combined Notice of Filings #1

    Take notice that the Commission received the following electric rate filings:

    Docket Numbers: ER18-2400-001.

    Applicants: New York Independent System Operator, Inc.

    Description: Compliance filing: NYISO amended compliance filing—uplift reporting Order No 844 to be effective 3/15/2019.

    Filed Date: 11/15/18.

    Accession Number: 20181115-5149.

    Comments Due: 5 p.m. ET 12/6/18.

    Docket Numbers: ER18-2449-001.

    Applicants: Midcontinent Independent System Operator, Inc., ALLETE, Inc.

    Description: Tariff Amendment: 2018-11-15_SA 3167 Enbridge-SWL&P FRA Substitute (Nemadji) to be effective 9/19/2018.

    Filed Date: 11/15/18.

    Accession Number: 20181115-5132.

    Comments Due: 5 p.m. ET 12/6/18.

    Docket Numbers: ER19-310-001.

    Applicants: Midcontinent Independent System Operator, Inc.

    Description: Tariff Amendment: 2018-11-15_SA 3200_Sholes Wind-MidAmerican Substitute Original FCA (C027) to be effective 10/25/2018.

    Filed Date: 11/15/18.

    Accession Number: 20181115-5164.

    Comments Due: 5 p.m. ET 12/6/18.

    Docket Numbers: ER19-341-000.

    Applicants: Midcontinent Independent System Operator, Inc.

    Description: § 205(d) Rate Filing: 2018-11-14_SA 1756 METC-Consumers Energy 12th Rev GIA (G479B) to be effective 11/1/2018.

    Filed Date: 11/14/18.

    Accession Number: 20181114-5127.

    Comments Due: 5 p.m. ET 12/5/18.

    Docket Numbers: ER19-342-000.

    Applicants: Lancaster County Solid Waste Management Authority.

    Description: Baseline eTariff Filing: Reactive Power Tariff Application to be effective 1/1/2019.

    Filed Date: 11/14/18.

    Accession Number: 20181114-5133.

    Comments Due: 5 p.m. ET 12/5/18.

    Docket Numbers: ER19-343-000.

    Applicants: ISO New England Inc., New England Power Pool Participants Committee.

    Description: § 205(d) Rate Filing: ISO-NE and NEPOOL; Updates to Assumptions Used in the ICR and Related Values to be effective 1/14/2019.

    Filed Date: 11/15/18.

    Accession Number: 20181115-5049.

    Comments Due: 5 p.m. ET 12/6/18.

    Docket Numbers: ER19-344-000.

    Applicants: Georgia Power Company.

    Description: § 205(d) Rate Filing: GPCo 2018 PBOP Filing to be effective 1/1/2018.

    Filed Date: 11/15/18.

    Accession Number: 20181115-5060.

    Comments Due: 5 p.m. ET 12/6/18.

    Docket Numbers: ER19-345-000.

    Applicants: Mississippi Power Company.

    Description: § 205(d) Rate Filing: PBOP 2018 Filing to be effective 1/1/2018.

    Filed Date: 11/15/18.

    Accession Number: 20181115-5066.

    Comments Due: 5 p.m. ET 12/6/18.

    Docket Numbers: ER19-346-000.

    Applicants: Southern Electric Generating Company.

    Description: § 205(d) Rate Filing: SEGCo 2018 PBOP Filing to be effective 1/1/2018.

    Filed Date: 11/15/18.

    Accession Number: 20181115-5067.

    Comments Due: 5 p.m. ET 12/6/18.

    Docket Numbers: ER19-347-000.

    Applicants: Midcontinent Independent System Operator, Inc.

    Description: § 205(d) Rate Filing: 2018-11-15_SA 3205 Clinton Wind-Duke Energy GIA (J446) to be effective 10/31/2018.

    Filed Date: 11/15/18.

    Accession Number: 20181115-5100.

    Comments Due: 5 p.m. ET 12/6/18.

    Docket Numbers: ER19-348-000.

    Applicants: PJM Interconnection, L.L.C.

    Description: § 205(d) Rate Filing: Amendment to 5 Service Agreements re: Transfer of parent company to Glidepath to be effective 7/13/2004.

    Filed Date: 11/15/18.

    Accession Number: 20181115-5146.

    Comments Due: 5 p.m. ET 12/6/18.

    Docket Numbers: ER19-349-000.

    Applicants: Midcontinent Independent System Operator, Inc.

    Description: § 205(d) Rate Filing: 2018-11-15_Termination of SA 2914 NSP-Ashtabula Wind IV FCA (C019) to be effective 12/1/2018.

    Filed Date: 11/15/18.

    Accession Number: 20181115-5150.

    Comments Due: 5 p.m. ET 12/6/18.

    The filings are accessible in the Commission's eLibrary system by clicking on the links or querying the docket number.

    Any person desiring to intervene or protest in any of the above proceedings must file in accordance with Rules 211 and 214 of the Commission's Regulations (18 CFR 385.211 and 385.214) on or before 5:00 p.m. Eastern time on the specified comment date. Protests may be considered, but intervention is necessary to become a party to the proceeding.

    eFiling is encouraged. More detailed information relating to filing requirements, interventions, protests, service, and qualifying facilities filings can be found at: http://www.ferc.gov/docs-filing/efiling/filing-req.pdf. For other information, call (866) 208-3676 (toll free). For TTY, call (202) 502-8659.

    Dated: November 15, 2018. Nathaniel J. Davis, Sr., Deputy Secretary.
    [FR Doc. 2018-25371 Filed 11-20-18; 8:45 am] BILLING CODE 6717-01-P
    ENVIRONMENTAL PROTECTION AGENCY [EPA-HQ-OW-2015-0641; FRL-9986-92-OW] Proposed Information Collection Request; Comment Request; Information Collection Request for Reporting Requirements for BEACH Act Grants (Renewal) AGENCY:

    Environmental Protection Agency (EPA).

    ACTION:

    Notice.

    SUMMARY:

    The Environmental Protection Agency (EPA) is planning to submit an information collection request (ICR), “Information Collection Request for Reporting Requirements for BEACH Act Grants” (EPA ICR No. 2048.06, OMB Control No. 2040-0244) to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act. Before doing so, the EPA is soliciting public comments on specific aspects of the proposed information collection as described below. This is a proposed extension of the ICR, which is currently approved through July 31, 2019. An Agency may not conduct or sponsor and a person is not required to respond to a collection of information unless it displays a currently valid OMB control number.

    DATES:

    Additional comments must be submitted on or before January 22, 2019.

    ADDRESSES:

    Submit your comments, referencing Docket ID Number EPA-HQ-OW-2015-0641 to the EPA (1) online using www.regulations.gov (our preferred method), or (2) by mail to: EPA Docket Center, Environmental Protection Agency, Mail Code 28221T, 1200 Pennsylvania Ave. NW, Washington, DC 20460.

    The EPA's policy is that all comments received will be included in the public docket without change including any personal information provided, unless the comment includes profanity, threats, information claimed to be Confidential Business Information (CBI) or other information whose disclosure is restricted by statute.

    FOR FURTHER INFORMATION CONTACT:

    Tracy Bone, OW, 4305T, Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460; telephone number: 202-564-5257; email address: [email protected].

    SUPPLEMENTARY INFORMATION:

    Supporting documents which explain in detail the information that the EPA will be collecting are available in the public docket for this ICR. The docket can be viewed online at www.regulations.gov or in person at the EPA Docket Center, WJC West, Room 3334, 1301 Constitution Ave. NW, Washington, DC. The telephone number for the Docket Center is 202-566-1744. For additional information about the EPA's public docket, visit http://www.epa.gov/dockets.

    Pursuant to section 3506(c)(2)(A) of the PRA, the EPA is soliciting comments and information to enable it to: (i) Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the Agency, including whether the information will have practical utility; (ii) evaluate the accuracy of the Agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (iii) enhance the quality, utility, and clarity of the information to be collected; and (iv) minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated electronic, mechanical, or other technological collection techniques or other forms of information technology, e.g., permitting electronic submission of responses. The EPA will consider the comments received and amend the ICR as appropriate. The final ICR package will then be submitted to OMB for review and approval. At that time, the EPA will issue another Federal Register notice to announce the submission of the ICR to OMB and the opportunity to submit additional comments to OMB.

    Abstract: The Beaches Environmental Assessment and Coastal Health (BEACH) Act amends the Clean Water Act (CWA) in part and authorizes the U.S. Environmental Protection Agency (EPA) to award BEACH Act Program Development and Implementation Grants to coastal and Great Lakes states, tribes, and territories (collectively referred to as jurisdictions) for their beach monitoring and notification programs. The grants assist those jurisdictions to develop and implement a consistent approach to monitor recreational water quality; assess, manage, and communicate health risks from waterborne microbial contamination; notify the public of pollution occurrences, and post beach advisories and closures to prevent public exposure to microbial pathogens. To qualify for a BEACH Act Grant, a jurisdiction must submit information to the EPA documenting that its beach monitoring and notification program is consistent with performance criteria outlined in the National Beach Guidance and Required Performance Criteria for Grants, 2014 Edition.

    Form numbers: None.

    Respondents/affected entities: Entities potentially affected by this action are environmental and public health agencies in coastal and Great Lakes states, territories, and tribes.

    Respondent's obligation to respond: Required to obtain the grants as directed by the BEACH Act amendment to the CWA.

    Estimated number of respondents: 39.

    Frequency of response: Annual; however, the agency encourages more frequent reporting to provide more up-to-date information to the public.

    Total estimated burden: 88,569 hours (per year). Burden is defined at 5 CFR 1320.03(b).

    Total estimated cost: $14,865,812 (per year), includes $11,063,780 (per year) operation & maintenance costs. There are no capital costs.

    Changes in estimates: There is a decrease of 2,707 hours in the total respondent burden compared with the ICR approved by OMB in July 2015 due to the respondents no longer needing to prepare and submit schedules for the adoption of new or revised WQS and identification and use of a beach notification threshold (BNT). The EPA no longer requests respondents submit these schedules because they are using BNTs or alternate BNTs and have either adopted new or revised WQS or are in the process of doing so. This decrease in hours is partially offset by one additional tribe having qualified for a BEACH grant. The total respondent cost decreased by $587,496. The decrease in cost is partially offset by slight increases in the salary rates. The O&M decreased by $289,366 due to a reduction in the total number of beaches (affecting O&M). The number of beaches reported by the jurisdictions varies from year to year for many reasons. Reasons for removing beaches include the destruction of beaches by natural disasters, change in beach ownership, and existing beaches being combined within a jurisdiction's monitoring and notification program.

    Dated: November 13, 2018. Deborah G. Nagle, Acting Director, Office of Science and Technology.
    [FR Doc. 2018-25423 Filed 11-20-18; 8:45 am] BILLING CODE 6560-50-P
    ENVIRONMENTAL PROTECTION AGENCY [EPA-HQ-OW-2018-0614; FRL-9986-79-OW] Request for Public Review and Comment: Draft Human Health Toxicity Assessments for Hexafluoropropylene Oxide Dimer Acid and Its Ammonium Salt (GenX Chemicals) and for Perfluorobutane Sulfonic Acid (PFBS) and Related Compound Potassium Perfluorobutane Sulfonate AGENCY:

    Environmental Protection Agency (EPA).

    ACTION:

    Notice of public comment period.

    SUMMARY:

    The Environmental Protection Agency (EPA) is announcing a 60-day public comment period associated with the release of two draft toxicity assessments for public comment:

    • Draft Human Health Toxicity Values for Hexafluoropropylene Oxide (HFPO) Dimer Acid and its Ammonium Salt (GenX Chemicals).

    • Draft Human Health Toxicity Values for Perfluorobutane Sulfonic Acid (PFBS) and Related Compound Potassium Perfluorobutane Sulfonate.

    The EPA developed the draft assessments to provide the health effects information available for GenX chemicals and PFBS and describe how that information was used to derive draft toxicity values. These draft toxicity assessments underwent independent, external expert peer review in June-July 2018. Following closure of this 60-day public comment period, the EPA will consider the comments, revise the draft documents, and consider the need for additional peer review, as appropriate, and then publish final toxicity assessments. The toxicity assessments for GenX chemicals and PFBS are scientific and technical reports that include toxicity values associated with potential noncancer health effects following oral exposure (in this case, oral reference doses [RfDs]). These assessments evaluate human health hazards. The toxicity assessments and the values contained within are not risk assessments as they do not include exposure assessments or provide a risk characterization. Further, the toxicity assessments do not address the legal, political, social, economic, or technical considerations involved in risk management. When issued, the toxicity assessments can be used by the EPA, states, tribes, and local communities, along with specific exposure and other relevant information, to determine, under the appropriate regulations and statutes, if and when it is necessary to take action to address potential risk associated with human exposures to these per- and polyfluoroalkyl substances (PFAS) chemicals.

    DATES:

    Comments must be received on or before January 22, 2019.

    ADDRESSES:

    Submit your comments, identified by Docket ID No. EPA-HQ-OW-2018-0614, to the public docket at: http://www.regulations.gov. Follow the online instructions for submitting comments. Once submitted, comments cannot be edited or withdrawn. The EPA may publish any comment received to its public docket. Do not submit electronically any information you consider to be Confidential Business Information (CBI) or other information whose disclosure is restricted by statute. Multimedia submissions (audio, video, etc.) must be accompanied by a written comment. The written comment is considered the official comment and should include discussion of all points you wish to make. The EPA will generally not consider comments or comment contents located outside of the primary submission (i.e., on the web, cloud, or other file sharing system). For additional submission methods, the full EPA public comment policy, information about CBI or multimedia submissions, and general guidance on making effective comments, please visit http://www2.epa.gov/dockets/commenting-epa-dockets.

    FOR FURTHER INFORMATION CONTACT:

    For information on the docket, contact the docket manager: Assem Akram, Docket Manager, EPA Docket Center, telephone: (202) 566-0226; or email: [email protected].

    For technical information on GenX chemicals: Dr. Jamie Strong, Health and Ecological Criteria Division, Office of Water (Mail Code 4304T), Environmental Protection Agency, 1200 Pennsylvania Avenue NW, Washington, DC 20460; telephone: (202) 566-0056; or email: [email protected].

    For technical information on PFBS: Dr. Samantha Jones, National Center for Environmental Assessment, Office of Research and Development (Mail Code 8602R), Environmental Protection Agency, 1200 Pennsylvania Avenue NW, Washington, DC 20460; telephone: 202-564-6794; or email: [email protected].

    SUPPLEMENTARY INFORMATION: I. General Information

    Supporting documents are available in the public docket for this ICR (under Docket ID number EPA-HQ-OW-2018-0614. The docket can be viewed online at http://www.regulations.gov or in person at the EPA Docket Center, WJC West, Room 3334, 1301 Constitution Ave. NW, Washington, DC. The telephone number for the Docket Center is 202-566-1744. For additional information about the EPA's public docket, visit http://www.epa.gov/dockets.

    A. Does this action apply to me?

    This request for public comment will not impose any requirements on anyone. Instead, this action notifies interested parties of the availability of draft toxicity assessments for GenX Chemicals and PFBS for public comment. It should be noted that when final these toxicity assessments may be used by the EPA, states, tribes, and local communities, along with specific exposure and other relevant information, to determine, under the appropriate regulations and statutes, if and when it is necessary to take action to address potential risk associated with human exposures to these PFAS chemicals.

    B. What should I consider as I prepare my comments for the EPA?

    1. Submit your comments, identified by Docket ID No. EPA-HQ-OW-2018-0614, at https://www.regulations.gov (our preferred method), or the other methods identified in the ADDRESSES section. Once submitted, comments cannot be edited or removed from the docket. The EPA may publish any comment received to its public docket. Do not submit electronically any information you consider to be Confidential Business Information (CBI) or other information whose disclosure is restricted by statute. Clearly mark the part or all of the information that you claim to be CBI. For CBI information in a disk or CD-ROM that you mail to the EPA, mark the outside of the disk or CD-ROM as CBI and then identify electronically within the disk or CD-ROM the specific information that is claimed as CBI. In addition to one complete version of the comment that includes information claimed as CBI, a copy of the comment that does not contain the information claimed as CBI must be submitted for inclusion in the public docket. Information so marked will not be disclosed except in accordance with procedures set forth in the Code of Federal Regulations (CFR) at 40 CFR part 2. Multimedia submissions (audio, video, etc.) must be accompanied by a written comment. The written comment is considered the official comment and should include discussion of all points you wish to make. The EPA will generally not consider comments or comment contents located outside of the primary submission (i.e., on the web, cloud, or other file sharing system). For additional submission methods, the full EPA public comment policy, information about CBI or multimedia submissions, and general guidance on making effective comments, please visit https://www.epa.gov/dockets/commenting-epa-dockets.

    II. What are GenX chemicals and PFBS?

    GenX chemicals and PFBS are man-made, fluorinated organic chemicals that are part of a larger group of manmade chemicals referred to as per- and polyfluoroalkyl substances (PFAS). PFAS are used in many applications because of their unique physical properties such as resistance to high and low temperatures, resistance to degradation, and nonstick characteristics. GenX is a trade name for a processing aid technology used to make high-performance fluoropolymers without the use of perfluorooctanoic acid (PFOA). Hexafluoropropylene oxide (HFPO) dimer acid and its ammonium salt are the major chemicals associated with the GenX processing aid technology and the focus of the draft assessment. PFBS is a four-carbon PFAS that was developed as a replacement for longer-chain PFAS, which have demonstrated environmental persistence, long half-lives and bioaccumulation in humans. PFBS has been integrated into various consumer products and applications.

    III. What are EPA's draft toxicity assessments?

    The EPA's draft toxicity assessments for GenX Chemicals and PFBS provide information on hazard identification and dose-response, including draft subchronic and chronic oral reference doses (RfDs) for each chemical. Overall, the available oral toxicity studies demonstrate that the liver is particularly sensitive to GenX chemicals, and the thyroid and kidney are sensitive to PFBS. The draft toxicity assessments underwent independent, external peer review in June and July 2018 and were revised accordingly.

    In the risk assessment/risk management paradigm, a toxicity assessment is on the risk assessment side of the paradigm. The draft toxicity assessments for GenX chemicals and PFBS address the first two steps (Step 1. Hazard Identification and Step 2. Dose-Response) of the four-step risk assessment process described by the National Academy of Science in 1983 as “the characterization of the potential adverse health effects of human exposures to environmental hazards.” Characterizing risk involves integrating information on hazard, dose-response, and exposure. For further details about risk assessments see: https://www.epa.gov/risk/conducting-human-health-risk-assessment.

    When issued, the toxicity values for GenX chemicals and PFBS can be combined with specific exposure information (Step 3. Exposure Assessment) by government and private entities to help characterize (Step 4. Risk Characterization) potential public health risks associated with exposure to these chemicals. Thus, once the GenX chemicals and PFBS assessments are issued, the EPA will work with our state, tribal, and local partners to provide technical assistance, including information about appropriate regulations and statutes, as they begin considering the final values in relevant exposure scenarios. It is the risk management part of the risk assessment/risk management paradigm where the supporting science, as well as statutory and legal considerations, risk management options, public health considerations, cost/benefit considerations, economic factors, social factors, and other considerations are weighed.

    The EPA recognizes that humans have the potential to be exposed to complex mixtures of PFAS and other chemicals and pathogens through drinking water and other exposure sources. The EPA's draft assessments for GenX chemicals and PFBS focus solely on the potential human health effects associated with oral exposure to each chemical; they do not consider potential cumulative (mixture) effects of GenX chemicals and PFBS or their possible interactions with other PFAS and/or other chemicals. This would involve a more complex assessment that would need to consider and evaluate mechanisms of action and endpoints of concern for each of the chemicals in the mixture.

    IV. Why is the EPA releasing draft toxicity assessments for these chemicals?

    The EPA is issuing the draft toxicity assessments for PFBS and GenX chemicals for public comment to give interested stakeholders and the public an opportunity to provide input to the Agency. The public will have 60 days after publication in the Federal Register to provide input. At the end of the comment period, the EPA will evaluate the input, make appropriate revisions, and finalize the toxicity assessments. Once the toxicity assessments are issued, the EPA will work with our state, tribal, and local partners to provide technical assistance, as they begin using the final values in relevant exposure scenarios to generate risk assessments to support risk management decisions.

    V. Solicitation of Public Comment

    During the 60-day comment period, the EPA is soliciting public comments regarding the science and technical approaches used in the derivation of the draft toxicity assessments for GenX chemicals and PFBS.

    In the PFBS assessment, due to the lack of epidemiological studies demonstrating adverse effects in humans, the EPA derived candidate subchronic RfDs (see Section 6.1.1 of the toxicity assessment) and candidate chronic RfDs (see Section 6.1.2 of the toxicity assessment) for both thyroid effects and kidney effects in rodent toxicity studies. In light of the consistent observation of the thyroid effects across life stages and the greater dose-response sensitivity, relative to the kidney effects, the EPA is proposing to base the overall subchronic and chronic RfDs on the thyroid effects and is requesting public review and comment on this proposal in addition to the approaches and conclusions in the PFBS assessment. Additionally, as described in Section 6.1 of the PFBS toxicity assessment, decreased serum total T4 (thyroxine) in newborn mice was used as the basis for the thyroid-related candidate RfDs. Peer reviewers provided comments on thyroid effects and this choice of endpoint. See pages 15-25 and 31-32 in the Response to Peer Review Comments on the Draft Human Health Toxicity Values for Perfluorobutane Sulfonic Acid (CASRN 375-73-5) and Related Compound Potassium Perfluorobutane Sulfonate (CASRN 29420-49-3) for the array of peer review comments on these topics and the EPA's responses. These supporting documents are available in the public docket for this ICR (under Docket ID number EPA-HQ-OW-2018-0614. Comments from the public are requested on the thyroid effects, this choice of endpoint, as well as the discussion on thyroid hormone economy in humans and animals (see Section 6.1 of the PFBS toxicity assessment).

    These draft assessments are not final as described in the EPA's information quality guidelines, and do not represent Agency policy or views. The EPA will consider all public comments submitted in response to this notice when revising these documents.

    Dated: November 14, 2018. David P. Ross, Assistant Administrator, Office of Water.
    [FR Doc. 2018-25422 Filed 11-20-18; 8:45 am] BILLING CODE 6560-50-P
    FEDERAL DEPOSIT INSURANCE CORPORATION FDIC Systemic Resolution Advisory Committee; Notice of Meeting AGENCY:

    Federal Deposit Insurance Corporation (FDIC).

    ACTION:

    Notice of open meeting.

    SUMMARY:

    In accordance with the Federal Advisory Committee Act, notice is hereby given of a meeting of the FDIC Systemic Resolution Advisory Committee, which will be held in Washington, DC. The Advisory Committee will provide advice and recommendations on a broad range of policy issues regarding the resolution of systemically important financial companies.

    DATES:

    Thursday, December 6, 2018, from 9:00 a.m. to 4:00 p.m.

    ADDRESSES:

    The meeting will be held in the FDIC Board Room on the sixth floor of the FDIC Building located at 550 17th Street NW, Washington, DC.

    FOR FURTHER INFORMATION CONTACT:

    Requests for further information concerning the meeting may be directed to Mr. Robert E. Feldman, Committee Management Officer of the FDIC, at (202) 898-7043.

    SUPPLEMENTARY INFORMATION:

    Agenda: The agenda will include a discussion of a range of issues and developments related to the resolution of systemically important financial companies. The agenda may be subject to change. Any changes to the agenda will be announced at the beginning of the meeting.

    Type of Meeting: The meeting will be open to the public, limited only by the space available on a first-come, first-served basis. For security reasons, members of the public will be subject to security screening procedures and must present a valid photo identification to enter the building. The FDIC will provide attendees with auxiliary aids (e.g., sign language interpretation) required for this meeting. Those attendees needing such assistance should call (703) 562-6067 (Voice or TTY) at least two days before the meeting to make necessary arrangements. Written statements may be filed with the committee before or after the meeting. This meeting of the FDIC Systemic Resolution Advisory Committee will be Webcast live via the internet http://fdic.windrosemedia.com. Questions or troubleshooting help can be found at the same link. For optimal viewing, a high-speed internet connection is recommended. Further, a video of the meeting will be available on-demand approximately two weeks after the event.

    Dated: November 16, 2018. Federal Deposit Insurance Corporation. Robert E. Feldman, Executive Secretary.
    [FR Doc. 2018-25366 Filed 11-20-18; 8:45 am] BILLING CODE 6714-01-P
    FEDERAL MARITIME COMMISSION Notice of Agreement Filed

    The Commission hereby gives notice of the filing of the following agreement under the Shipping Act of 1984. Interested parties may submit comments on the agreement to the Secretary by email at [email protected], or by mail, Federal Maritime Commission, Washington, DC 20573, within twelve days of the date this notice appears in the Federal Register. A Copy of the agreement is available through the Commission's website (www.fmc.gov) or by contacting the Office of Agreements at (202)-523-5793 or [email protected].

    Agreement No.: 011707-016.

    Agreement Name: Gulf/South America Discussion Agreement.

    Parties: BBC Chartering Carriers GmbH & Co. KG; Industrial Maritime Carriers, LLC; Seaboard Marine Ltd.; and ZEAMARINE Carrier GmbH.

    Filing Party: Wade Hooker.

    Synopsis: The amendment removes the sections into which the parties are currently divided, adds ad hoc space charter authority, adds joint service contract authority, and adds ZEAMARINE Carrier GmbH as a party to the Agreement.

    Proposed Effective Date: 12/27/2018.

    Location: https://www2.fmc.gov/FMC.Agreements.Web/Public/AgreementHistory/684.

    Dated: November 16, 2018. Rachel Dickon, Secretary.
    [FR Doc. 2018-25389 Filed 11-20-18; 8:45 am] BILLING CODE 6731-AA-P
    FEDERAL MARITIME COMMISSION [Docket No. 18-10] Logfret, Inc., Complainant v. Kirsha, B.V., Leendert Johanness Bergwerff a/k/a Hans Bergwerff, Linda Sieval, Respondents; Notice of Filing of Complaint and Assignment November 16, 2018.

    Notice is given that a complaint has been filed with the Federal Maritime Commission (Commission) by Logfret, Inc., hereinafter “Complainant”, against Kirsha, B.V., Leendert Johanness Bergwerff a/k/a Hans Bergwerff, and Linda Sieval, hereinafter “Respondents”. Complainant states that it “. . . provides transport, logistics and related shipping services to customers in the United States and worldwide” and is licensed by the Commission. Complainant states that it “. . . is an affiliate of Logfret, B.V. . . . ” Complainant states that “. . . Respondent Kirsha, B.V. is a corporation organized and existing under the laws of the Netherlands. . . .” Complainant states that “Respondent Ms. Linda Sieval, a Dutch national, was a sales manager for Logfret B.V. until the termination of her employment on March 1, 2018. Complainant states that Respondent Mr. Hans Bergwerff, is “. . . a Dutch national, who exercises signatory authority and direct control over Kirsha, B.V.”

    Complainant alleges that Respondents, in the course of their management of Logret B.V., violated 46 U.S.C. 41103(a) by unlawfully routing shipments to a competitor, and improper use of Complainant's bill of lading.

    Complainant seeks reparations in the amount of $2,000,000 and other relief. The full text of the complaint can be found in the Commission's Electronic Reading Room at www.fmc.gov/18-10.

    This proceeding has been assigned to Office of Administrative Law Judges. The initial decision of the presiding office in this proceeding shall be issued by November 18, 2019, and the final decision of the Commission shall be issued by June 1, 2020.

    Rachel E. Dickon, Secretary.
    [FR Doc. 2018-25415 Filed 11-20-18; 8:45 am] BILLING CODE 6731-AA-P
    FEDERAL RESERVE SYSTEM Change in Bank Control Notices; Acquisitions of Shares of a Bank or Bank Holding Company

    The notificants listed below have applied under the Change in Bank Control Act (12 U.S.C. 1817(j)) and § 225.41 of the Board's Regulation Y (12 CFR 225.41) to acquire shares of a bank or bank holding company. The factors that are considered in acting on the notices are set forth in paragraph 7 of the Act (12 U.S.C. 1817(j)(7)).

    The notices are available for immediate inspection at the Federal Reserve Bank indicated. The notices also will be available for inspection at the offices of the Board of Governors. Interested persons may express their views in writing to the Reserve Bank indicated for that notice or to the offices of the Board of Governors. Comments must be received not later than December 7, 2018.

    A. Federal Reserve Bank of Chicago (Colette A. Fried, Assistant Vice President) 230 South LaSalle Street, Chicago, Illinois 60690-1414:

    1. 2018 Grantor Trust FBO Rachel Grimstad and 2018 Grantor Trust FBO Gus Grimstad, with Padrin Grimstad as trustee, together with the 2018 Grantor Trust FBO Max Grimstad and 2018 Grantor Trust FBO Oscar Grimstad, with Ann Grimstad as trustee, all of Decorah, Iowa; to join the Grimstad Family Control Group approved on September 21, 2005, and acquire voting shares of Security Agency, Inc., and thereby indirectly acquire voting shares of Decorah Bank and Trust Company, both in Decorah, Iowa.

    Board of Governors of the Federal Reserve System, November 16, 2018. Yao-Chin Chao, Assistant Secretary of the Board.
    [FR Doc. 2018-25383 Filed 11-20-18; 8:45 am] BILLING CODE P
    FEDERAL RESERVE SYSTEM Agency Information Collection Activities: Announcement of Board Approval Under Delegated Authority and Submission to OMB AGENCY:

    Board of Governors of the Federal Reserve System.

    SUMMARY:

    The Board of Governors of the Federal Reserve System (Board) is adopting a proposal to revise for three years, without extension, the Capital Assessments and Stress Testing (FR Y-14A/Q/M; OMB No. 7100-0341). The revisions are applicable with the reports as of December 31, 2018.

    FOR FURTHER INFORMATION CONTACT:

    Federal Reserve Board Clearance Officer—Nuha Elmaghrabi—Office of the Chief Data Officer, Board of Governors of the Federal Reserve System, Washington, DC 20551, (202) 452-3829. Telecommunications Device for the Deaf (TDD) users may contact (202) 263-4869, Board of Governors of the Federal Reserve System, Washington, DC 20551.

    OMB Desk Officer—Shagufta Ahmed—Office of Information and Regulatory Affairs, Office of Management and Budget, New Executive Office Building, Room 10235, 725 17th Street NW, Washington, DC 20503, or by fax to (202) 395-6974.

    SUPPLEMENTARY INFORMATION:

    On June 15, 1984, the Office of Management and Budget (OMB) delegated to the Board authority under the Paperwork Reduction Act (PRA) to approve and assign OMB control numbers to collection of information requests and requirements conducted or sponsored by the Board. Board-approved collections of information are incorporated into the official OMB inventory of currently approved collections of information. Copies of the Paperwork Reduction Act Submission, supporting statements and approved collection of information instrument(s) are placed into OMB's public docket files. The Board may not conduct or sponsor, and the respondent is not required to respond to, an information collection that has been extended, revised, or implemented on or after October 1, 1995, unless it displays a currently valid OMB control number.

    Final Approval Under OMB Delegated Authority of the Revision, Without Extension, of the Following Information Collection:

    Report title: Capital Assessments and Stress Testing.

    Agency form number: FR Y-14A/Q/M.

    OMB control number: 7100-0341.

    Effective Date: December 31, 2018.

    Frequency: Annually, semi-annually, quarterly, and monthly.

    Respondents: The respondent panel consists of any top-tier bank holding company (BHC) that has $100 billion or more in total consolidated assets, as determined based on: (i) The average of the firm's total consolidated assets in the four most recent quarters as reported quarterly on the firm's FR Y-9C; or (ii) the average of the firm's total consolidated assets in the most recent consecutive quarters as reported quarterly on the firm's FR Y-9Cs, if the firm has not filed an FR Y-9C for each of the most recent four quarters. The respondent panel also consists of any U.S. intermediate holding company (IHC). Reporting is required as of the first day of the quarter immediately following the quarter in which the respondent meets this asset threshold, unless otherwise directed by the Board.

    Estimated number of respondents: 36.

    Estimated average hours per response: FR Y-14A: Summary, 887 hours; Macro Scenario, 31 hours; Operational Risk, 18 hours; Regulatory Capital Instruments, 21 hours; Business Plan Changes, 16 hours; and Adjusted Capital Plan Submission, 100 hours. FR Y-14Q: Retail, 15 hours; Securities, 13 hours; PPNR, 711 hours; Wholesale, 151 hours; Trading, 1,926 hours; Regulatory Capital Transitions, 23 hours; Regulatory Capital Instruments, 54 hours; Operational Risk, 50 hours; MSR Valuation, 23 hours; Supplemental, 4 hours; Retail FVO/HFS, 15 hours; Counterparty, 514 hours; and Balances, 16 hours. FR Y-14M: 1st Lien Mortgage, 516 hours; Home Equity, 516 hours; and Credit Card, 512 hours. FR Y-14 On-going Automation Revisions, 480 hours. FR Y-14 Attestation On-going Audit and Review, 2,560 hours.

    Estimated annual reporting hours: FR Y-14A: Summary, 63,864 hours; Macro Scenario, 2,232 hours; Operational Risk, 648 hours; Regulatory Capital Instruments, 756 hours; Business Plan Changes, 576 hours; and Adjusted Capital Plan Submission, 500 hours. FR Y-14Q: Retail, 2,160 hours; Securities, 1,872 hours; Pre-Provision Net Revenue (PPNR), 102,385 hours; Wholesale, 21,744 hours; Trading, 92,448 hours; Regulatory Capital Transitions, 3,312 hours; Regulatory Capital Instruments, 7,776 hours; Operational risk, 7,200 hours; Mortgage Servicing Rights (MSR) Valuation, 1,380 hours; Supplemental, 576 hours; Retail Fair Value Option/Held for Sale (Retail FVO/HFS), 1,500 hours; Counterparty, 24,672 hours; and Balances, 2,304 hours. FR Y-14M: 1st Lien Mortgage, 210,528 hours; Home Equity, 173,376 hours; and Credit Card, 86,016 hours. FR Y-14 On-going Automation Revisions, 17,280 hours. FR Y-14 Attestation On-going Audit and Review, 33,280 hours.

    General description of report: These collections of information are applicable to top-tier BHCs with total consolidated assets of $100 billion or more and U.S. IHCs. This family of information collections is composed of the following three reports:

    • The semi-annual FR Y-14A, which collects quantitative projections of balance sheet, income, losses, and capital across a range of macroeconomic scenarios, and qualitative information on methodologies used to develop internal projections of capital across scenarios.1

    1 Firms that must re-submit their capital plan generally also must provide a revised FR Y-14A in connection with their resubmission. See 12 CFR 225.8(d)(4).

    • The quarterly FR Y-14Q, which collects granular data on various asset classes, including loans, securities, trading assets, and pre-provision net revenue (PPNR) for the reporting period.

    • The monthly FR Y-14M, which is comprised of three retail portfolio- and loan-level schedules, and one detailed address matching schedule to supplement two of the portfolio- and loan-level schedules.

    Respondent firms are currently required to submit up to 18 filings each year: 2 semi-annual FR Y-14A filings, 4 quarterly FR Y-14Q filings, and 12 monthly FR Y-14M filings.

    Legal authorization and confidentiality: The FR Y-14 A/Q/M reports are mandatory. The Board has the authority to require BHCs to file the FR Y-14A/Q/M reports pursuant to section 5 of the Bank Holding Company Act (BHC Act) (12 U.S.C. 1844), and to require the U.S. IHCs of Foreign Banking Organizations to file the FR Y-14 A/Q/M reports pursuant to section 5 of the BHC Act, in conjunction with section 8 of the International Banking Act (12 U.S.C. 3106).

    The information collected in these reports is collected as part of the Board's supervisory process, and therefore is afforded confidential treatment pursuant to exemption 8 of the Freedom of Information Act (FOIA) (5 U.S.C. 552(b)(8)). In addition, individual respondents may request that certain data be afforded confidential treatment pursuant to exemption 4 of FOIA if the data has not previously been publically disclosed and the release of the data would likely cause substantial harm to the competitive position of the respondent (5 U.S.C. 552(b)(4)). Determinations of confidentiality based on exemption 4 of FOIA would be made on a case-by-case basis.

    Current actions: On August 8, 2018, the Board published a notice in the Federal Register (83 FR 39093) requesting public comment for 60 days on the revision, without extension, of the Capital Assessments and Stress Testing (FR Y-14A/Q/M). The Board proposed revising sub-schedule L.5 (Derivatives and SFT Profile) of the FR Y-14Q, Schedule L (Counterparty) by adding back mistakenly omitted items for total stressed net current exposure to be reported under the two supervisory stressed scenarios. With the addition of these items, the instructions would be changed to modify the associated ranking methodologies for the yearly stressed/CCAR submission in sub-schedule L.5 to require the top 25 counterparties to be reported as ranked by the total stressed net current exposure. The comment period for this notice expired on October 9, 2018. The Board received one comment from a banking organization. The commenter requested that the Board adopt these changes and publish the associated materials as soon as possible in order to provide adequate time to implement and test the changes. The Board strives to provide as much time as possible in advance of the effective date for firms to implement revisions. The draft forms and instructions were made available with the publication of the initial notice. The revisions, including draft forms and instructions, will be implemented as proposed as of December 31, 2018.

    Board of Governors of the Federal Reserve System, November 15, 2018. Yao-Chin Chao, Assistant Secretary of the Board.
    [FR Doc. 2018-25339 Filed 11-20-18; 8:45 am] BILLING CODE 6210-01-P
    FEDERAL RESERVE SYSTEM Agency Information Collection Activities: Announcement of Board Approval Under Delegated Authority and Submission to OMB AGENCY:

    Board of Governors of the Federal Reserve System.

    SUMMARY:

    The Board of Governors of the Federal Reserve System (Board) is adopting a proposal to extend for three years, with revision, the Reporting, Recordkeeping, and Disclosure Requirements Associated with the Home Mortgage Disclosure Act (HMDA) and Loan/Application Register (LAR) required by Regulation C (FR HMDA LAR, OMB No. 7100-0247).

    FOR FURTHER INFORMATION CONTACT:

    Federal Reserve Board Clearance Officer—Nuha Elmaghrabi—Office of the Chief Data Officer, Board of Governors of the Federal Reserve System, Washington, DC 20551 (202) 452-3829. Telecommunications Device for the Deaf (TDD) users may contact (202) 263-4869, Board of Governors of the Federal Reserve System, Washington, DC 20551.

    OMB Desk Officer—Shagufta Ahmed—Office of Information and Regulatory Affairs, Office of Management and Budget, New Executive Office Building, Room 10235, 725 17th Street NW, Washington, DC 20503 or by fax to (202) 395-6974.

    SUPPLEMENTARY INFORMATION:

    On June 15, 1984, the Office of Management and Budget (OMB) delegated to the Board authority under the Paperwork Reduction Act (PRA) to approve and assign OMB control numbers to collection of information requests and requirements conducted or sponsored by the Board. Board-approved collections of information are incorporated into the official OMB inventory of currently approved collections of information. Copies of the Paperwork Reduction Act Submission, supporting statements and approved collection of information instrument(s) are placed into OMB's public docket files. The Board may not conduct or sponsor, and the respondent is not required to respond to, an information collection that has been extended, revised, or implemented on or after October 1, 1995, unless it displays a currently valid OMB control number.

    Final approval under OMB delegated authority of the extension for three years, with revision, of the following information collection:

    Report title: Reporting, Recordkeeping, and Disclosure Requirements Associated with the Home Mortgage Disclosure Act (HMDA) and Loan/Application Register (LAR) required by Regulation C.

    Agency form number: FR HMDA LAR.

    OMB control number: 7100-0247.

    Frequency: Annually and quarterly.

    Respondents: State member banks (SMBs), their subsidiaries, subsidiaries of bank holding companies, U.S. branches and agencies of foreign banks (other than federal branches, federal agencies, and insured state branches of foreign banks), commercial lending companies owned or controlled by foreign banks, and organizations operating under section 25 or 25A of the Federal Reserve Act.

    Estimated number of respondents: Update policies, procedures, and systems (one-time), 505 respondents; Reporting—Tier 1 (annual reporter), 2 respondents; Tier 1 (quarterly reporter), 1 respondent; Tier 2, 148 respondents; Tier 2 (Crapo), 300 respondents; and Tier 3 (Crapo), 54 respondents; Recordkeeping—Tier 1 (annual reporter), 2 respondents; Tier 1 (quarterly reporter), 1 respondent; Tier 2, 448 respondents; and Tier 3, 54 respondents; and Disclosure—Tier 1 (annual reporter), 2 respondents; and Tier 1 (quarterly reporter), 1 respondent.

    Estimated average hours per response: Update policies, procedures, and systems (one-time), 176 hours; Reporting—Tier 1 (annual reporter), 5,969 hours; Tier 1 (quarterly reporter), 6,903 hours; Tier 2, 1,232 hours; Tier 2 (Crapo), 986 hours; and Tier 3 (Crapo), 64 hours; Recordkeeping—Tier 1 (annual reporter), 4,130 hours; Tier 1 (quarterly reporter), 4,130 hours; Tier 2, 83 hours; and Tier 3, 27 hours; and Disclosure—Tier 1 (annual reporter), 5 hours; and Tier 1 (quarterly reporter), 5 hours.

    Estimated annual burden hours: Update policies, procedures, and systems (one-time), 88,880 hours; Reporting—Tier 1 (annual reporter), 11,938 hours; Tier 1 (quarterly reporter), 27,612 hours; Tier 2, 182,336 hours; Tier 2: Crapo, 295,800 hours; and Tier 3: Crapo, 3,456 hours; Recordkeeping—Tier 1 (annual reporter), 8,260 hours; Tier 1 (quarterly reporter), 16,520 hours; Tier 2, 37,184 hours; and Tier 3, 1,458 hours; and Disclosure—Tier 1 (annual reporter), 10 hours; and Tier 1 (quarterly reporter), 20 hours.

    General description of report: HMDA was enacted in 1975 and is implemented by Regulation C. Generally, HMDA requires certain depository and non-depository institutions that make certain mortgage loans to collect, report, and disclose data about originations and purchases of mortgage loans, as well as loan applications that do not result in originations (for example, applications that are denied or withdrawn). HMDA was enacted to provide regulators and the public with loan data that can be used to: (1) Help determine whether financial institutions are serving the housing needs of their communities, (2) assist public officials in distributing public-sector investments so as to attract private investment to areas where it is needed, and (3) assist in identifying possible discriminatory lending patterns and enforcing anti-discrimination statutes.1 Supervisory agencies, state and local public officials, and members of the public use the data to aid in the enforcement of the Community Reinvestment Act, the Equal Credit Opportunity Act, and the Fair Housing Act and to aid in identifying areas for residential redevelopment and rehabilitation.

    1 12 CFR 1003.1(b).

    Legal authorization and confidentiality: The FR HMDA LAR is authorized pursuant to section 304(j) of HMDA (12 U.S.C. 2803(j)), which requires that the Bureau of Consumer Financial Protection (Bureau) prescribe by regulation the form of loan application register information that must be reported by covered financial institutions. Section 1003.5 of Regulation C implements this statutory provision, and requires covered financial institutions to submit reports to their appropriate federal agency. Section 304(h)(2)(A) of HMDA (12 U.S.C. 2803(h)(2)(A)) designates the Board as the appropriate agency with respect to the entities described above. The FR HMDA LAR is mandatory. HMDA requires the information collected on the FR HMDA LAR to be made available to the general public in the form proscribed by the Bureau. The Bureau is authorized to redact or modify the scope of the information before it is publicly disclosed to protect the privacy of loan applicants and to protect depository institutions from liability under any federal or state privacy law (12 U.S.C. 2803(j)(2)(B)). The redacted information may be kept confidential under exemption 6 of the Freedom and Information Act, which protects from release information that, if disclosed, would “constitute a clearly unwarranted invasion of personal privacy” (5 U.S.C. 552(b)(6)).

    Current actions: On August 28, 2018, the Board published a notice in the Federal Register (83 FR 43868) requesting public comment for 60 days on the extension, with revision, of the Reporting, Recordkeeping, and Disclosure Requirements Associated with the Home Mortgage Disclosure Act (HMDA) and Loan/Application Register (LAR) required by Regulation C. Consistent with the Bureau's final rules amending Regulation C, effective January 1, 2018, as well as recent statutory amendments to HMDA that were enacted on May 24, 2018,2 the Board proposes to revise the FR HMDA LAR by expanding the data reported and by modifying the types of institutions required to report and the types of loans required to be reported. Beginning January 1, 2018, an institution that is otherwise not eligible for a partial exemption under section 104(a) of the Economic Growth, Regulatory Relief, and Consumer Protection Act (EGRRCPA), as discussed further below, is required to collect and report all required data points required under HMDA if it either originates 25 or more 3 closed-end mortgage loans or 500 or more open-end lines of credit 4 secured by a dwelling in each of the two preceding years, in addition to meeting other applicable coverage criteria.5 For these institutions, the final rules standardize the loan volume threshold used to determine coverage of both depository and non-depository institutions. An institution will only report a covered loan if it has met the loan origination threshold for that loan category (open-end or closed-end).

    2 On May 24, 2018, the President signed into law the Economic Growth, Regulatory Relief, and Consumer Protection Act (EGRRCPA). In relevant part, section 104(a) of EGRRCPA amends HMDA to exempt certain insured depository institutions and insured credit unions from collecting and reporting those data fields that were required by HMDA sections 304(b)(5) and (6), as implemented by the Bureau's final rules.

    3 Small depository institutions that originated fewer than 25 closed-end mortgage loans in either 2015 or 2016 ceased HMDA data collection on January 1, 2017.

    4 Under the 2015 final rules, financial institutions would have been required to report home-equity lines of credit if they made 100 or more such loans in each of the last two years. On August 24, 2017, the Bureau amended the final rules to increase the institutional coverage and loan threshold from 100 to 500 or more loans through calendar years 2018 and 2019. See 82 FR 43088 (Sept. 13, 2017). This temporary increase in the threshold will provide time for the Bureau to consider whether to initiate another rulemaking to address the appropriate level for the threshold for data collected beginning January 1, 2020.

    5 Asset size and geographic location coverage tests also apply. See 12 CFR FR 1003.2(g).

    The final rules generally will require covered institutions to collect and report any mortgage loan secured by a dwelling, including open-end lines of credit, regardless of the loan's purpose. However, the final rules exclude unsecured home-improvement loans (which historically were required to be reported), dwelling-secured loans that are made principally for a commercial or business purpose, agricultural-purpose loans, and other specifically excluded loans.6

    6 12 CFR 1003.2(e).

    The final rules also will require collection of additional data points. For covered institutions that are otherwise not eligible for the partial exemption under section 104(a) of EGRRCPA, as discussed further below, these additional data points will be reported in 2019. These new fields include

    • Additional information about the applicant or borrower, such as age and credit score • information about the loan pricing, such as the borrower's total cost to obtain a mortgage, temporary introductory rates, and borrower-paid origination charges • information about loan features, such as the loan term, prepayment penalties, or non-amortizing features (such as interest only or balloon payments) • additional information about property securing the loan, such as property value and property type

    In addition, the Bureau's final rules amend several existing requirements, including the requirements for collection and reporting of information regarding an applicant's or borrower's ethnicity, race and sex.7

    7 For the complete list of data points, see 12 CFR 1003.4.

    Effective May 24, 2018, an institution that is eligible for the partial exemption under section 104(a) of EGRRCPA will only need to report a subset of the data points required under HMDA if it originates fewer than 500 closed-end mortgage loans in each of the two preceding calendar years.8 Consistent with section 104(a) of EGRRCPA and the Bureau's recent statement addressing the applicability of this statutory amendment to HMDA,9 the Board estimates that institutions eligible for the partial exemption will report approximately half the data points currently required by the Bureau's final rules on the loans described above.10

    8 Section 104(a) of EGRRCPA also provides a partial exemption to the data collection and reporting requirements under HMDA for institutions that originate fewer than 500 open-end lines of credit in each of the two preceding calendar years and otherwise meet the applicable performance evaluation rating standards under CRA. However, institutions eligible for this partial exemption are already completely exempt from all data collection and reporting requirements under the temporary exemption provided by the Bureau's final rules until January 1, 2020.

    9 See Bureau Statement, which provides that for loans subject to the partial exemption, “the requirements of [HMDA section 304(b)(5) an (6)] shall not apply . . . [therefore,] institutions are exempt from the collection, recording, and reporting requirements for some, but not all, of the data points specified in current Regulation C.”

    10 Section 104(a) of EGRRCPA does not define the terms “closed-end loan” or “open-end line of credit.” However, for purposes of estimating burden, the Board is making the assumption that these terms will be used consistent with how they are currently defined in Regulation C. See 12 CFR 1002.2(d) and (o), which defines the term “closed-end loan” and “open-end line of credit,” respectively. Further, for purposes of estimating burden, the Board is making the assumption that the loan volume thresholds for closed-end loans will be determined consistent with how such loan thresholds are currently used under Regulation C to determine if a transaction must be reported. See 12 CFR 1003.3(c)(11) and (12), which provides how to determine the loan threshold volume for closed-end loan reporters and open-end line of credit reporters, respectively.

    The Bureau will collect the HMDA/LAR data on behalf of the applicable Federal supervisory agency, and the data will be combined and aggregated for each Metropolitan Statistical Area (MSA). Certain aggregated data will continue to be publicly available, though the Bureau has yet to determine what the information collected in the new data fields will be disclosed once the final rules are fully effective. The comment period for this notice expired on October 29, 2018. The Board did not receive any comments. The revisions will be implemented as proposed.

    Board of Governors of the Federal Reserve System, November 15, 2018. Yao-Chin Chao, Assistant Secretary of the Board.
    [FR Doc. 2018-25338 Filed 11-20-18; 8:45 am] BILLING CODE 6210-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Administration for Community Living Administration on Intellectual and Developmental Disabilities, President's Committee for People With Intellectual Disabilities AGENCY:

    Administration for Community Living, HHS.

    ACTION:

    Notice.

    SUMMARY:

    The President's Committee for People with Intellectual Disabilities (PCPID) will host a webinar/conference call for its members to discuss the potential topics of the Committee's 2019 Report to the President. All the PCPID meetings, in any format, are open to the public. This virtual meeting will be conducted in a discussion format.

    DATES:

    Webinar/Conference Call: Wednesday, December 5, 2018 from 9:00 a.m. to 10:00 a.m. (EST).

    FOR FURTHER INFORMATION CONTACT:

    Ms. Allison Cruz, Director, Office of Innovation, 330 C Street SW, Switzer Building, Room 1114, Washington, DC 20201. Telephone: 202-795-7334. Fax: 202-795-7334. Email: [email protected].

    SUPPLEMENTARY INFORMATION:

    The purpose of this virtual meeting is to discuss the Committee's preparation of the PCPID 2019 Report to the President, including its content and format, and related data collection and analysis required to complete the writing of the Report.

    Webinar/Conference Call: The webinar/conference call is scheduled for Wednesday, December 5, 2018, 9:00 a.m. to 10:00 a.m. (EST) and may end early if discussions are finished.

    Instructions to Participate in the Webinar/Conference Call on Wednesday, December 5, 2018: Please dial: (888) 949-2790; Pass Code: 1989852

    Background Information on the Committee: The PCPID acts in an advisory capacity to the President and the Secretary of Health and Human Services on a broad range of topics relating to programs, services and support for individuals with intellectual disabilities. The PCPID executive order stipulates that the Committee shall: (1) Provide such advice concerning intellectual disabilities as the President or the Secretary of Health and Human Services may request; and (2) provide advice to the President concerning the following for people with intellectual disabilities: (A) Expanding employment opportunities; (B) connecting people to services; (C) supporting families and caregivers; (D) strengthening the networks; and (E) protecting rights and preventing abuse.

    Dated: November 15, 2018. Julie Hocker, Commissioner, Administration on Disabilities (AoD).
    [FR Doc. 2018-25375 Filed 11-20-18; 8:45 am] BILLING CODE 4154-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2018-N-3522] Use of the Names of Dairy Foods in the Labeling of Plant-Based Products; Extension of Comment Period AGENCY:

    Food and Drug Administration, HHS.

    ACTION:

    Notice; extension of comment period.

    SUMMARY:

    The Food and Drug Administration (FDA or we) is extending the comment period for the notice that appeared in the Federal Register of September 28, 2018. In the notice, FDA invited interested parties to provide information on specific topics related to the labeling of plant-based products with names that include the names of dairy foods such as “milk,” “cultured milk,” “yogurt,” and “cheese.” We are extending the comment period to give interested parties more time to comment.

    DATES:

    FDA is extending the comment period on the notice published in the Federal Register of September 28, 2018 (83 FR 49103). Submit either electronic or written comments by January 28, 2019.

    ADDRESSES:

    You may submit comments as follows. Please note that late, untimely filed comments will not be considered. Electronic comments must be submitted on or before January 28, 2019. The https://www.regulations.gov electronic filing system will accept comments until 11:59 p.m. Eastern Time at the end of January 28, 2019. Comments received by mail/hand delivery/courier (for written/paper submissions) will be considered timely if they are postmarked or the delivery service acceptance receipt is on or before that date.

    Electronic Submissions

    Submit electronic comments in the following way:

    Federal eRulemaking Portal: https://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to https://www.regulations.gov will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else's Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on https://www.regulations.gov.

    • If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see “Written/Paper Submissions” and “Instructions”).

    Written/Paper Submissions

    Submit written/paper submissions as follows:

    Mail/Hand delivery/Courier (for written/paper submissions): Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

    • For written/paper comments submitted to the Dockets Management Staff, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in “Instructions.”

    Instructions: All submissions received must include the Docket No. FDA-2018-N-3522 for “Use of the Names of Dairy Foods in the Labeling of Plant-Based Products.” Received comments, those filed in a timely manner (see ADDRESSES), will be placed in the docket and, except for those submitted as “Confidential Submissions,” publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through Friday.

    • Confidential Submissions—To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states “THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.” We will review this copy, including the claimed confidential information, in our consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on https://www.regulations.gov. Submit both copies to the Dockets Management Staff. If you do not wish your name and contact information to be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify this information as “confidential.” Any information marked as “confidential” will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law. For more information about FDA's posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: https://www.thefederalregister.org/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.

    Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in the heading of this document, into the “Search” box and follow the prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

    FOR FURTHER INFORMATION CONTACT:

    Mabel Lee, Center Food Safety and Applied Nutrition, Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, 240-402-2371.

    SUPPLEMENTARY INFORMATION:

    In the Federal Register of September 28, 2018 (83 FR 49103), FDA published a notice with a 60-day comment period inviting interested parties to provide information on specific topics related to the labeling of plant-based products with names that include the names of dairy foods such as “milk,” “cultured milk,” “yogurt,” and “cheese.” The information will inform our development of an approach to the labeling of plant-based products that consumers may substitute for dairy foods. We asked that comments be submitted by November 27, 2018.

    We have received requests for a 120-day extension of the comment period for the notice. The requests conveyed concern that the current 60-day comment period does not allow sufficient time to develop meaningful or thoughtful responses to the questions that appeared in the notice requesting data and other evidence in support of answers.

    We have considered the requests and are extending the comment period for another 60 days, until January 28, 2019. We believe that a 60-day extension allows adequate time for interested persons to submit comments without significantly delaying any potential further action on these important issues.

    Dated: November 15, 2018. Leslie Kux, Associate Commissioner for Policy.
    [FR Doc. 2018-25347 Filed 11-20-18; 8:45 am] BILLING CODE 4164-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2008-N-0500] Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; General Licensing Provisions; Requirements on Content and Format of Labeling for Human Prescription Drug and Biological Products AGENCY:

    Food and Drug Administration, HHS.

    ACTION:

    Notice.

    SUMMARY:

    The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.

    DATES:

    Fax written comments on the collection of information by December 21, 2018.

    ADDRESSES:

    To ensure that comments on the information collection are received, OMB recommends that written comments be faxed to the Office of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, Fax: 202-395-7285, or emailed to [email protected]. All comments should be identified with the OMB control number 0910-0572. Also include the FDA docket number found in brackets in the heading of this document.

    FOR FURTHER INFORMATION CONTACT:

    JonnaLynn Capezzuto, Office of Operations, Food and Drug Administration, Three White Flint North, 10A-12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-3794, [email protected].

    SUPPLEMENTARY INFORMATION:

    In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance.

    Requirements on Content and Format of Labeling for Human Prescription Drug and Biological Products OMB Control Number 0910-0572—Extension

    FDA's regulations governing the content and format of labeling for human prescription drug and biological products were revised in the Federal Register of January 24, 2006 (71 FR 3922) (the 2006 labeling rule) to require that the labeling of new and recently approved products contain highlights of prescribing information, a table of contents for prescribing information, reordering of certain sections, minor content changes, and minimum graphical requirements. These revisions were intended to make it easier for health care practitioners to access, read, and use information in prescription drug labeling; to enhance the safe and effective use of prescription drug products; and to reduce the number of adverse reactions resulting from medication errors because of misunderstood or incorrectly applied drug information.

    Currently, § 201.56 (21 CFR 201.56) requires that prescription drug labeling contain certain information in the format specified in either § 201.57 (21 CFR 201.57) or § 201.80 (21 CFR 201.80), depending on when the drug was approved for marketing. Section 201.56(a) sets forth general labeling requirements applicable to all prescription drugs. Section 201.56(b) specifies the categories of new and more recently approved prescription drugs subject to the revised content and format requirements in §§ 201.56(d) and 201.57. Section 201.56(c) sets forth the schedule for implementing these revised content and format requirements. Section 201.56(e) specifies the sections and subsections, required and optional, for the labeling of older prescription drugs not subject to the revised format and content requirements.

    Section 201.57(a) requires that prescription drug labeling for new and more recently approved prescription drug products include a “Highlights of Prescribing Information” section. The “Highlights” section provides a concise extract of the most important information required under § 201.57(c) (the Full Prescribing Information (FPI)), as well as certain additional information important to prescribers. Section 201.57(b) requires a table of contents to prescribing information entitled “Full Prescribing Information: Contents,” consisting of a list of each heading and subheading along with its identifying number to facilitate health care practitioners' use of labeling information. Section 201.57(c) specifies the contents of the FPI. Section 201.57(d) mandates the minimum specifications for the format of prescription drug labeling and establishes minimum requirements for key graphic elements such as bold type, bullet points, type size, and spacing.

    Older drugs not subject to the revised labeling content and format requirements in § 201.57 are subject to labeling requirements at § 201.80. Section 201.80(f)(2) requires that, within 1 year, any FDA-approved patient labeling be referenced in the “Precautions” section of the labeling of older products and either accompany or be reprinted immediately following the labeling.

    Annual Burden for Prescription Drug Labeling Design, Testing, and Submitting to FDA for New Drug Applications (NDAs) and Biologics License Applications (BLAs) (§§ 201.56 and 201.57)

    New drug product applicants must: (1) Design and create prescription drug labeling containing “Highlights,” “Contents,” and FPI; (2) test the designed labeling (e.g., to ensure that the designed labeling fits into carton-enclosed products); and (3) submit it to FDA for approval. Based on the projected data used in the January 24, 2006, final rule, FDA estimates that it will take applicants approximately 2,327 hours to design, test, and submit prescription drug labeling to FDA as part of a NDA or a BLA under the revised regulations. Currently, approximately 406 applicants submit approximately 541 new applications (NDAs and BLAs) to FDA annually, totaling 1,258,907 hours.

    In the Federal Register of July 20, 2018 (83 FR 34596), we published a 60-day notice requesting public comment on the proposed collection of information. We received two comments. One comment encouraged the use of “provider-neutral language” in specific regulations. The second comment discussed the distribution of package inserts for prescription drugs via paper labeling. Because these comments do not apply to the regulations associated with the information collection, we have not addressed them here.

    Our estimate of the burden for the information collection is as follows:

    Table 1—Estimated Annual Reporting Burden 1 21 CFR part and activity Number of
  • respondents
  • Number of
  • responses per
  • respondent 2
  • Total annual responses Average
  • burden per
  • response
  • Total hours
    Labeling Requirements in §§ 201.56 and 201.57 406 1.332 541 2,327 1,258,907 1 There are no capital costs or operating and maintenance costs associated with this collection of information. 2 Estimates may not sum due to rounding.

    Our estimated burden for the information collection reflects an overall increase of 602,503 hours and a corresponding increase of 345 records. We attribute this adjustment to an increase in the number of submissions we received over the last few years.

    Dated: November 14, 2018. Leslie Kux, Associate Commissioner for Policy.
    [FR Doc. 2018-25352 Filed 11-20-18; 8:45 am] BILLING CODE 4164-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Charter Renewal of the Advisory Committee on Blood and Tissue Safety and Availability AGENCY:

    Office of HIV/AIDS and Infectious Disease Policy, Office of the Assistant Secretary for Health, Office of the Secretary, Department of Health and Human Services.

    ACTION:

    Notice.

    SUMMARY:

    The Department of Health and Human Services is hereby giving notice that the charter for the Advisory Committee on Blood and Tissue Safety and Availability (ACBTSA) has been renewed.

    FOR FURTHER INFORMATION CONTACT:

    Mr. James Berger, Designated Federal Officer for the ACBTSA, Senior Advisor for Blood and Tissue Policy, Office of the Assistant Secretary for Health, Department of Health and Human Services, Mary E. Switzer Building, 330 C Street SW, Suite L100, Washington, DC 20024. Phone: (202) 795-7697; Fax: (202) 691-2102; Email: [email protected].

    SUPPLEMENTARY INFORMATION:

    ACBTSA is a non-discretionary Federal advisory committee. ACBTSA is authorized under 42 U.S.C. 217a, Section 222 of the Public Health Service (PHS) Act, as amended. The Committee is governed by the provisions of the Federal Advisory Committee Act (FACA), Public Law 92-463, as amended (5 U.S.C. App), which sets forth standards for the formation and use of advisory committees.

    The ACBTSA advises, assists, consults with, and makes policy recommendations to the Secretary, through the Assistant Secretary for Health, regarding these broad responsibilities related to the safety of blood, blood products, tissues, and organs. For solid organs and blood stem cells, the Committee's work is limited to policy issues related to donor derived infectious disease complications of transplantation.

    To carry out its mission, the ACBTSA provides advice to the Secretary through the Assistant Secretary for Health on a range of policy issues to include: (1) Identification of public health issues through surveillance of blood and tissue safety issues with national biovigilance data tools; (2) identification of public health issues that affect availability of blood, blood products, and tissues; (3) broad public health, ethical, and legal issues related to the safety of blood, blood products, and tissues; (4) the impact of various economic factors (e.g., product cost and supply) on safety and availability of blood, blood products, and tissues; (5) risk communications related to blood transfusion and tissue transplantation; and (6) identification of infectious disease transmission issues for blood, organs, blood stem cells and tissues.

    On September 25, 2018, the Secretary approved for the ACBTSA charter to be renewed. The new charter was effected and filed with the appropriate Congressional committees and the Library of Congress on October 9, 2018. Renewal of the Committee's charter gives authorization for the Committee to continue to operate until October 9, 2020.

    A copy of the ACBTSA charter is available on the Committee's website at https://www.hhs.gov/ohaidp/initiatives/blood-tissue-safety/advisory-committee/charter/index.html. A copy of the charter can also be obtained by accessing the FACA database that is maintained by the Committee Management Secretariat under the General Services Administration. The website address for the FACA database is www.facadatabase.gov.

    Dated: October 19, 2018. James J. Berger, Senior Advisor for Blood and Tissue Policy, Designated Federal Officer, Advisory Committee on Blood and Tissue Safety and Availability.
    [FR Doc. 2018-25374 Filed 11-20-18; 8:45 am] BILLING CODE 4150-41-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Heart, Lung, and Blood Institute; Notice of Closed Meeting

    Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended, notice is hereby given of the following meeting.

    The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.

    Name of Committee: Heart, Lung, and Blood Initial Review Group; NHLBI Institutional Training Mechanism Review Committee.

    Date: December 14, 2018.

    Time: 9:30 a.m. to 3:00 p.m.

    Agenda: To review and evaluate grant applications.

    Place: National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892 (Telephone Conference Call).

    Contact Person: Lindsay M. Garvin, Ph.D., Scientific Review Officer, Office of Scientific Review/DERA, National Heart, Lung, and Blood Institute, 6701 Rockledge Drive; Suite 7189, Bethesda, MD 20892, 301-827-7911, [email protected].

    (Catalogue of Federal Domestic Assistance Program Nos. 93.233, National Center for Sleep Disorders Research; 93.837, Heart and Vascular Diseases Research; 93.838, Lung Diseases Research; 93.839, Blood Diseases and Resources Research, National Institutes of Health, HHS)
    Dated: November 15, 2018. Ronald J. Livingston, Jr., Program Analyst, Office of Federal Advisory Committee Policy.
    [FR Doc. 2018-25354 Filed 11-20-18; 8:45 am] BILLING CODE 4140-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute on Aging; Notice of Closed Meeting

    Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended, notice is hereby given of the following meeting.

    The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.

    Name of Committee: National Institute on Aging Special Emphasis Panel; Health and Aging Trends.

    Date: December 3, 2018.

    Time: 2:00 p.m. to 5:00 p.m.

    Agenda: To review and evaluate grant applications.

    Place: National Institute on Aging, Gateway Building, Room 2W200, 7201 Wisconsin Avenue, Bethesda, MD 20892, (Telephone Conference Call).

    Contact Person: Kimberly Firth, Ph.D., National Institutes of Health, National Institute on Aging, Gateway Building, 7201 Wisconsin Avenue, Suite 2C212, Bethesda, MD 20892, 301-402-7702, [email protected].

    This notice is being published less than 15 days prior to the meeting due to the timing limitations imposed by the review and funding cycle.

    (Catalogue of Federal Domestic Assistance Program Nos. 93.866, Aging Research, National Institutes of Health, HHS)
    Dated: November 15, 2018. Natasha M. Copeland, Program Analyst, Office of Federal Advisory Committee Policy.
    [FR Doc. 2018-25351 Filed 11-20-18; 8:45 am] BILLING CODE 4140-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute of Neurological Disorders and Stroke; Notice of Closed Meetings

    Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended, notice is hereby given of the following meetings.

    The meetings will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.

    Name of Committee: National Institute of Neurological Disorders and Stroke Special Emphasis Panel; Review of R35 Research Program Award.

    Date: December 3-4, 2018.

    Time: 8:00 a.m. to 6:00 p.m.

    Agenda: To review and evaluate grant applications.

    Place: Embassy Suites Alexandria Old Town, Virginia Ballroom A & B, 1900 Diagonal Rd, Alexandria, VA 22314.

    Contact Person: Jimok Kim, Ph.D., Scientific Review Officer, Scientific Review Branch, Division of Extramural Activities, NINDS/NIH/DHHS, NSC, 6001 Executive Blvd., Suite 3226, MSC 9529, Bethesda, MD 20892-9529, (301) 496-9223, [email protected].

    This notice is being published less than 15 days prior to the meeting due to the timing limitations imposed by the review and funding cycle.

    Name of Committee: National Institute of Neurological Disorders and Stroke Special Emphasis Panel; Biomarkers Discovery in Parkinsonism.

    Date: December 3, 2018.

    Time: 9:00 a.m. to 5:00 p.m.

    Agenda: To review and evaluate grant applications.

    Place: National Institutes of Health, Neuroscience Center, 6001 Executive Boulevard, Rockville, MD 20852, (Telephone Conference Call).

    Contact Person: Joel A. Saydoff, Ph.D., Scientific Review Officer, Scientific Review Branch, Division of Extramural Activities, NINDS/NIH/DHHS, NSC, 6001 Executive Blvd., Suite 3205, MSC 9529, Bethesda, MD 20892-9529, (301) 496-9223, [email protected].

    This notice is being published less than 15 days prior to the meeting due to the timing limitations imposed by the review and funding cycle.

    (Catalogue of Federal Domestic Assistance Program Nos. 93.853, Clinical Research Related to Neurological Disorders; 93.854, Biological Basis Research in the Neurosciences, National Institutes of Health, HHS)
    Dated: November 14, 2018. Sylvia L. Neal, Program Analyst, Office of Federal Advisory Committee Policy.
    [FR Doc. 2018-25355 Filed 11-20-18; 8:45 am] BILLING CODE 4140-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Heart, Lung, and Blood Institute; Notice of Meetings

    Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended, notice is hereby given of the following meetings.

    The meetings will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.

    Name of Committee: National Heart, Lung, and Blood Institute Special Emphasis Panel; Conference Grants in Support of Heart, Lung, and Blood Research.

    Date: December 11-12, 2018.

    Time: 8:00 a.m. to 5:30 p.m.

    Agenda: To review and evaluate grant applications.

    Place: National Institutes of Health, 6701 Rockledge Drive, Room 7296, Bethesda, MD 20892 (Virtual Meeting).

    Contact Person: Stephanie J. Webb, Ph.D., Scientific Review Officer, Office of Scientific Review, National Heart, Lung, and Blood Institute, National Institutes of Health, 6701 Rockledge Drive, Room 7196, Bethesda, MD 20892, 301-287-7332, [email protected].

    (Catalogue of Federal Domestic Assistance Program Nos. 93.233, National Center for Sleep Disorders Research; 93.837, Heart and Vascular Diseases Research; 93.838, Lung Diseases Research; 93.839, Blood Diseases and Resources Research, National Institutes of Health, HHS)
    Dated: November 15, 2018. Ronald J. Livingston, Jr., Program Analyst, Office of Federal Advisory Committee Policy.
    [FR Doc. 2018-25353 Filed 11-20-18; 8:45 am] BILLING CODE 4140-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Center for Scientific Review; Notice of Closed Meeting

    Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended, notice is hereby given of the following meeting.

    The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.

    Name of Committee: Center for Scientific Review Special Emphasis Panel; Member Conflict: Chronic Neurodegenerative Diseases.

    Date: December 11, 2018.

    Time: 1:00 p.m. to 3:30 p.m.

    Agenda: To review and evaluate grant applications.

    Place: National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892 (Telephone Conference Call).

    Contact Person: Seetha Bhagavan, Ph.D., Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 5194, MSC 7846, Bethesda, MD 20892, (301) 237-9838, [email protected].

    (Catalogue of Federal Domestic Assistance Program Nos. 93.306, Comparative Medicine; 93.333, Clinical Research, 93.306, 93.333, 93.337, 93.393-93.396, 93.837-93.844, 93.846-93.878, 93.892, 93.893, National Institutes of Health, HHS)
    Dated: November 15, 2018. Ronald J. Livingston, Jr., Program Analyst, Office of Federal Advisory Committee Policy.
    [FR Doc. 2018-25356 Filed 11-20-18; 8:45 am] BILLING CODE 4140-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Substance Abuse and Mental Health Services Administration Fiscal Year (FY) 2019 Funding Opportunity AGENCY:

    Substance Abuse and Mental Health Services Administration, HHS.

    ACTION:

    Notice of intent to award a single source grant to the Community Anti-Drug Coalitions of America (CADCA).

    SUMMARY:

    This notice is to inform the public that the Substance Abuse and Mental Health Services Administration (SAMHSA) intends to award $500,000 (total costs) for up to five years to CADCA for the National Anti-Drug Coalitions Training and Workforce Development Grant. Under this initiative, CADCA will provide training to state and community prevention leaders, including members of anti-drug community coalitions from around the country who are committed to addressing the evolving needs of the behavioral health field, and promote workforce development. Training and workforce development activities supported through this grant include SAMHSA's Prevention Day, the CADCA National Leadership Forum, and CADCA's Mid-Year Training Institute. These activities aim to disseminate knowledge and transfer state-of-the-art information, assisting state and community leaders in developing and implementing evidence-based programs, practices, and policies aligned with the 21st Century Cures Act, the Comprehensive Addition and Recovery Act, the President's Commission on combating drug addiction and the opioid crisis, and other national substance abuse prevention goals, outcomes, and efforts, including underage drinking prevention. This is not a formal request for applications. Assistance will be provided only to CADCA based on the receipt of a satisfactory application that is approved by an independent review group.

    Funding Opportunity Title: SP-19-002.

    Catalog of Federal Domestic Assistance (CFDA) Number: 93.243.

    Authority: Section 516 of the Public Health Services Act, as amended.

    Justification

    Eligibility for this award is limited to CADCA. The purpose of this grant to provide training and workforce development for thousands of members of community coalitions dedicated to preventing substance abuse through a national leadership workforce development and training event. CADCA is the only national organization that has special expertise and unique broad, national-level experience in working with community anti-drug coalitions. For more than 22 years, coalitions and coalition leadership have turned to CADCA to obtain the assistance they need to implement, operate, and sustain effective local community anti-drug strategies. CADCA will take advantage of the resources of multiple agencies located throughout the federal, state and local governments, philanthropies, and universities to bring the best available knowledge, information, and technology to local community anti-drug coalitions working to prevent and reduce drug use among the youth of America. CADCA is the only identified organization with the required experience and national reach to over 5,000 identified anti-drug coalitions across the country. Significant investments were made over the years to support this program with outstanding results. CADCA has long been recognized in communities as well as states throughout the nation for the technical support it has provided to anti-drug coalitions. As such, it is uniquely qualified and positioned to carry out the requirements of this announcement.

    Contact: Odessa Crocker, Substance Abuse and Mental Health Services Administration, 5600 Fishers Lane, Rockville, MD 20857; telephone: (240) 276-1078; email: [email protected].

    Dated: November 15, 2018. Carlos Castillo, Committee Management Officer.
    [FR Doc. 2018-25349 Filed 11-20-18; 8:45 am] BILLING CODE 4162-20-P
    DEPARTMENT OF HOMELAND SECURITY Coast Guard [Docket No. USCG-2018-0792] Collection of Information Under Review by Office of Management and Budget; OMB Control Number: 1625-0035 AGENCY:

    Coast Guard, DHS.

    ACTION:

    Thirty-day notice requesting comments.

    SUMMARY:

    In compliance with the Paperwork Reduction Act of 1995 the U.S. Coast Guard is forwarding an Information Collection Request (ICR), to the Office of Management and Budget (OMB), Office of Information and Regulatory Affairs (OIRA), requesting an extension of its approval for a collection of information regarding: 1625-0035, Title 46 CFR Subchapter Q: Lifesaving, Electrical, Engineering and Navigation Equipment, Construction and Materials & Marine Sanitation Devices (33 CFR part 159); without change. Our ICR describes the information we seek to collect from the public. Review and comments by OIRA ensure we only impose paperwork burdens commensurate with our performance of duties.

    DATES:

    Comments must reach the Coast Guard and OIRA on or before December 21, 2018.

    ADDRESSES:

    You may submit comments identified by Coast Guard docket number [USCG-2018-0792] to the Coast Guard using the Federal eRulemaking Portal at https://www.regulations.gov. Alternatively, you may submit comments to OIRA using one of the following means:

    (1) Email: [email protected].

    (2) Mail: OIRA, 725 17th Street NW, Washington, DC 20503, attention Desk Officer for the Coast Guard.

    A copy of the ICR is available through the docket on the internet at https://www.regulations.gov. Additionally, copies are available from: Commandant (CG-612), Attn: Paperwork Reduction Act Manager, U.S. Coast Guard, 2703 Martin Luther King Jr. Ave. SE, STOP 7710, Washington, DC 20593-7710.

    FOR FURTHER INFORMATION CONTACT:

    Mr. Anthony Smith, Office of Information Management, telephone 202-475-3532, or fax 202-372-8405, for questions on these documents.

    SUPPLEMENTARY INFORMATION:

    In compliance with the Paperwork Reduction Act of 1995 the U.S. Coast Guard is forwarding an ICR to OMB, OIRA, requesting an extension of its approval for a collection of the following information: 1625-0035, Title 46 CFR Subchapter Q Lifesaving, Electrical, Engineering and Navigation Equipment, Construction and Materials & Marine Sanitation Devices (33 CFR part 159) without change.

    Public Participation and Request for Comments

    This Notice relies on the authority of the Paperwork Reduction Act of 1995; 44 U.S.C. Chapter 35, as amended. An ICR is an application to OIRA seeking the approval, extension, or renewal of a Coast Guard collection of information (Collection). The ICR contains information describing the Collection's purpose, the Collection's likely burden on the affected public, an explanation of the necessity of the Collection, and other important information describing the Collection. There is one ICR for each Collection.

    The Coast Guard invites comments on whether this ICR should be granted based on the Collection being necessary for the proper performance of Departmental functions. In particular, the Coast Guard would appreciate comments addressing: (1) The practical utility of the Collection; (2) the accuracy of the estimated burden of the Collection; (3) ways to enhance the quality, utility, and clarity of information subject to the Collection; and (4) ways to minimize the burden of the Collection on respondents, including the use of automated collection techniques or other forms of information technology. These comments will help OIRA determine whether to approve the ICR referred to in this Notice.

    We encourage you to respond to this request by submitting comments and related materials. Comments to Coast Guard or OIRA must contain the OMB Control Number of the ICR. They must also contain the docket number of this request, [USCG-2018-0792], and must be received by December 21, 2018

    Submitting Comments

    We encourage you to submit comments through the Federal eRulemaking Portal at https://www.regulations.gov. If your material cannot be submitted using https://www.regulations.gov, contact the person in the FOR FURTHER INFORMATION CONTACT section of this document for alternate instructions. Documents mentioned in this notice, and all public comments, are in our online docket at https://www.regulations.gov and can be viewed by following that website's instructions. Additionally, if you go to the online docket and sign up for email alerts, you will be notified when comments are posted.

    We accept anonymous comments. All comments received will be posted without change to https://www.regulations.gov and will include any personal information you have provided. For more about privacy and the docket, you may review a Privacy Act notice regarding the Federal Docket Management System in the March 24, 2005, issue of the Federal Register (70 FR 15086).

    OIRA posts its decisions on ICRs online at https://www.reginfo.gov/public/do/PRAMain after the comment period for each ICR. An OMB Notice of Action on each ICR will become available via a hyperlink in the OMB Control Number: 1625-0035.

    Previous Request for Comments

    This request provides a 30-day comment period required by OIRA. The Coast Guard published the 60-day notice (83 FR 45267, September 6, 2018) required by 44 U.S.C. 3506(c)(2). That notice elicited no comments. Accordingly, no changes have been made to the Collections.

    Information Collection Request

    Title: Title 46 CFR Subchapter Q: Lifesaving, Electrical, Engineering and Navigation Equipment, Construction and Materials & Marine Sanitation Devices (33 CFR part 159).

    OMB Control Number: 1625-0035.

    Summary: This information is used by the Coast Guard to ensure that regulations governing specific types of safety equipment, material and Marine Sanitation Devices (MSDs) installed on commercial vessels and pleasure craft are met. Manufacturers are required to submit drawings, specifications, and laboratory test reports to the Coast Guard before any approval is given.

    Need: Title 46 U.S.C. 2103, 3306, 3703, and 4302 authorize the Coast Guard to establish safety equipment and material regulations. Title 46 CFR parts 159 to 164 prescribe these requirements. Title 33 U.S.C. 1322 authorizes the Coast Guard to establish MSD regulations. Title 33 CFR part 159 prescribes these rules. NVIC 8-01 (Chg 3) prescribes the standards for navigation equipment. This information is used to determine whether manufacturers are in compliance with Coast Guard regulations. When the Coast Guard approves any safety equipment, material or MSD for use on a commercial vessel or pleasure craft, the manufacturer is issued a Certificate of Approval.

    Forms: CGHQ-10030, Certificate of Approval.

    Respondents: Manufacturers of safety equipment, materials and marine sanitation devices.

    Frequency: On occasion.

    Hour Burden Estimate: The estimated burden has decreased from 118,594 hours to 114,586 hours a year due to a decrease in the estimated annual number of responses.

    Authority:

    The Paperwork Reduction Act of 1995; 44 U.S.C. Chapter 35, as amended.

    Dated: November 14, 2018. James D. Roppel, Acting Chief, U.S. Coast Guard, Office of Information Management.
    [FR Doc. 2018-25268 Filed 11-20-18; 8:45 am] BILLING CODE 9110-04-P
    DEPARTMENT OF HOMELAND SECURITY U.S. Citizenship and Immigration Services [OMB Control Number 1615-0052] Agency Information Collection Activities; Revision of a Currently Approved Collection; Application for Naturalization AGENCY:

    U.S. Citizenship and Immigration Services, Department of Homeland Security.

    ACTION:

    60-Day notice.

    SUMMARY:

    The Department of Homeland Security (DHS), U.S. Citizenship and Immigration

    (USCIS) invites the general public and other Federal agencies to comment upon this proposed revision of a currently approved collection of information or new collection of information. In accordance with the Paperwork Reduction Act (PRA) of 1995, the information collection notice is published in the Federal Register to obtain comments regarding the nature of the information collection, the categories of respondents, the estimated burden (i.e. the time, effort, and resources used by the respondents to respond), the estimated cost to the respondent, and the actual information collection instruments.

    DATES:

    Comments are encouraged and will be accepted for 60 days until January 22, 2019.

    ADDRESSES:

    All submissions received must include the OMB Control Number 1615-0052 in the body of the letter, the agency name and Docket ID USCIS-2008-0025. To avoid duplicate submissions, please use only one of the following methods to submit comments:

    (1) Online. Submit comments via the Federal eRulemaking Portal website at http://www.regulations.gov under e-Docket ID number USCIS-2008-0025;

    (2) Mail. Submit written comments to DHS, USCIS, Office of Policy and Strategy, Chief, Regulatory Coordination Division, 20 Massachusetts Avenue NW, Washington, DC 20529-2140.

    FOR FURTHER INFORMATION CONTACT:

    USCIS, Office of Policy and Strategy, Regulatory Coordination Division, Samantha Deshommes, Chief, 20 Massachusetts Avenue NW, Washington, DC 20529-2140, telephone number 202-272-8377 (This is not a toll-free number. Comments are not accepted via telephone message). Please note contact information provided here is solely for questions regarding this notice. It is not for individual case status inquiries. Applicants seeking information about the status of their individual cases can check Case Status Online, available at the USCIS website at http://www.uscis.gov, or call the USCIS National Customer Service Center at 800-375-5283 (TTY 800-767-1833).

    SUPPLEMENTARY INFORMATION: Comments

    You may access the information collection instrument with instructions, or additional information by visiting the Federal eRulemaking Portal site at: http://www.regulations.gov and enter USCIS-2008-0025 in the search box. Regardless of the method used for submitting comments or material, all submissions will be posted, without change, to the Federal eRulemaking Portal at http://www.regulations.gov, and will include any personal information you provide. Therefore, submitting this information makes it public. You may wish to consider limiting the amount of personal information that you provide in any voluntary submission you make to DHS. DHS may withhold information provided in comments from public viewing that it determines may impact the privacy of an individual or is offensive. For additional information, please read the Privacy Act notice that is available via the link in the footer of http://www.regulations.gov.

    Written comments and suggestions from the public and affected agencies should address one or more of the following four points:

    (1) Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility;

    (2) Evaluate the accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used;

    (3) Enhance the quality, utility, and clarity of the information to be collected; and

    (4) Minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology, e.g., permitting electronic submission of responses.

    Overview of This Information Collection

    (1) Type of Information Collection: Revision of a Currently Approved Collection.

    (2) Title of the Form/Collection: Application for Naturalization.

    (3) Agency form number, if any, and the applicable component of the DHS sponsoring the collection: N-400; USCIS.

    (4) Affected public who will be asked or required to respond, as well as a brief abstract: Primary: Individuals or households. USCIS uses the information gathered on Form N-400 to make a determination as to a respondent's eligibility to naturalize and become a U.S. citizen.

    (5) An estimate of the total number of respondents and the amount of time estimated for an average respondent to respond: The estimated total number of respondents for the information collection N-400 (paper) is 567,314 and the estimated hour burden per response is 12 hours; the estimated total number of respondents for the information collection N-400 (electronic) is 214,186 and the estimated hour burden per response is 5 hours; and the estimated total number of respondents for the information collection Biometrics is 778,000 and the estimated hour burden per response is 1.17 hours.

    (6) An estimate of the total public burden (in hours) associated with the collection: The total estimated annual hour burden associated with this collection is 8,788,958.00 hours.

    (7) An estimate of the total public burden (in cost) associated with the collection: The estimated total annual cost burden associated with this collection of information is $346,768,927.50.

    Dated: November 15, 2018. Samantha L Deshommes, Chief, Regulatory Coordination Division, Office of Policy and Strategy, U.S. Citizenship and Immigration Services, Department of Homeland Security.
    [FR Doc. 2018-25345 Filed 11-20-18; 8:45 am] BILLING CODE 9111-97-P
    DEPARTMENT OF THE INTERIOR Fish and Wildlife Service [FWS-R8-ES-2018-N141; FXES11140800000-189-FF08EVEN00] Habitat Conservation Plan for Seven Species in the Santa Clara River Watershed; Categorical Exclusion for Foothill Feeder Inspection and Maintenance Activities, Los Angeles County, California AGENCY:

    Fish and Wildlife Service, Interior.

    ACTION:

    Notice of availability; request for comments.

    SUMMARY:

    We, the U.S. Fish and Wildlife Service (Service), have received an application from Metropolitan Water District of Southern California for an incidental take permit under the Endangered Species Act. The permit would authorize take of the federally endangered unarmored threespine stickleback, arroyo toad, the federally threatened California red-legged frog, and non-listed Santa Ana sucker, western spadefoot, two-striped garter snake, and western pond turtle incidental to otherwise lawful activities associated with the inspection and maintenance of the Foothill Feeder water conveyance pipeline in the draft habitat conservation plan prepared for the project. We invite public comment.

    DATES:

    Written comments should be received on or before December 21, 2018.

    ADDRESSES:

    To obtain documents: You may download a copy of the draft habitat conservation plan and draft low-effect screening form and environmental action statement at http://www.fws.gov/ventura/, or you may request copies of the documents by U.S. mail (below) or by phone (see FOR FURTHER INFORMATION CONTACT).

    To submit written comments: Please send us your written comments using one of the following methods:

    U.S. mail: Send your comments to Stephen P. Henry, Field Supervisor, Ventura Fish and Wildlife Office, U.S. Fish and Wildlife Service, 2493 Portola Road, Suite B, Ventura, CA 93003.

    Facsimile: Fax your comments to 805-644-3958.

    FOR FURTHER INFORMATION CONTACT:

    Chris Dellith, Fish and Wildlife Biologist, 805-677-3308 (phone), or at the Ventura address in ADDRESSES.

    SUPPLEMENTARY INFORMATION:

    We have received an application for an incidental take permit (ITP) pursuant to section 10(a)(1)(B) of the Endangered Species Act, as amended (ESA; 16 U.S.C. 1531 et seq.). The applicant has developed a draft habitat conservation plan (HCP) for the project that includes measures to mitigate and minimize impacts to seven covered species: the federally endangered unarmored threespine stickleback (Gasterosteus aculeatus williamsoni), a fish, and the arroyo toad (Anaxyrus californicus); the federally threatened California red-legged frog (Rana draytonii); and the non-listed Santa Ana sucker (Catostomus santaanae), a fish; western spadefoot (Spea hammondii), a toad; two-striped garter snake (Thamnophis hammondii); and western pond turtle (Emys marmorata). (The non-listed Santa Ana sucker (Catostomus santaanae) is federally listed as threatened outside of the area covered in the habitat conservation plan.) The permit would authorize take of any of these species incidental to otherwise lawful activities associated with the Foothill Feeder Inspection and Maintenance Activities HCP. We invite public comment on the application, the draft HCP, draft low-effect screening form, and environmental action statement.

    Background

    The unarmored threespine stickleback was listed by the Service as endangered on October 13, 1970 (35 FR 16047). The arroyo toad was listed by the Service as endangered on December 16, 1994 (59 FR 64859). The California red-legged frog was listed by the Service as threatened on May 23, 1996 (61 FR 25813). The Santa Ana sucker was listed by the Service as threatened, outside of the area covered by the draft HCP, on April 12, 2000 (65 FR 19686). The western spadefoot is currently under the Service's review for listing pursuant to the ESA (80 FR 37568). The two-striped garter snake is not federally listed, nor is it being considered for listing pursuant to the ESA at this time. The western pond turtle is currently under the Service's review for listing pursuant to the ESA (80 FR 19259). Section 9 of the ESA and its implementing regulations prohibit the take of fish or wildlife species listed as endangered or threatened. “Take” is defined under the ESA to include the following activities: “[T]o harass, harm, pursue, hunt, shoot, wound, kill, trap, capture, or collect, or to attempt to engage in any such conduct” (16 U.S.C. 1532); however, under section 10(a)(1)(B) of the ESA, we may issue permits to authorize incidental take of listed species. “Incidental take” is defined by the ESA as take that is incidental to, and not the purpose of, carrying out of an otherwise lawful activity. Regulations governing incidental take permits for threatened and endangered species are in the Code of Federal Regulations (CFR) at 50 CFR 17.32 and 17.22, respectively. Under the ESA, protections for federally listed plants differ from the protections afforded to federally listed animals. Issuance of an incidental take permit also must not jeopardize the existence of federally listed fish, wildlife, or plant species. The permittees would receive assurances under our “No Surprises” regulations ((50 CFR 17.22(b)(5) and 17.32(b)(5)) regarding conservation activities for the unarmored threespine stickleback, arroyo toad, California red-legged frog, Santa Ana sucker, western spadefoot, two-striped garter snake, and western pond turtle.

    Applicant's Proposed Activities

    The applicant has applied for a permit for incidental take of the unarmored threespine stickleback, arroyo toad, California red-legged frog, Santa Ana sucker, western spadefoot, two-striped garter snake, and western pond turtle. Take is likely to occur in association with activities necessary to inspect and maintain the Foothill Feeder water conveyance pipeline. The covered area consists of approximately 22 river miles, within the Santa Clara River watershed, of cottonwood-willow, transitional riparian, alluvial sage scrub, oak woodland, upland scrub, and aquatic habitat, which provides suitable habitat for the unarmored threespine stickleback, arroyo toad, California red-legged frog, Santa Ana sucker, western spadefoot, two-striped garter snake, and western pond turtle. The covered area has no designated critical habitat for the covered species. The HCP includes measures to minimize take of the covered species in the form of injury and mortality. Mitigation for unavoidable take of the species consists of creating, restoring, and enhancing up to 40 acres of cottonwood-willow, transitional riparian, alluvial sage scrub, oak woodland, upland scrub, and aquatic habitat.

    Our Preliminary Determination

    The Service made a preliminary determination that issuance of the incidental take permit is neither a major Federal action that will significantly affect the quality of the human environment within the meaning of section 102(2)(C) of NEPA (42 U.S.C. 4321 et seq.), nor will it individually or cumulatively have more than a negligible effect on the species covered in the HCP. The Service considers the effects of the taking of the covered species to be minor because project activities resulting in incidental take of the covered species would occur infrequently (approximately every 5 years over a period of several weeks), the applicant has proposed a series of measures to avoid and minimize impacts to the covered species, and the applicant has committed to creating, restoring, and enhancing up to 40 acres of occupied or otherwise suitable habitat for the covered species within the Santa Clara River watershed. Therefore, based on this preliminary determination, the permit qualifies for a categorical exclusion under NEPA.

    Public Comments

    If you wish to comment on the permit application, draft HCP, and associated documents, you may submit comments by one of the methods in ADDRESSES.

    Before including your address, phone number, email address, or other personal identifying information in your comment, you should be aware that your entire comment, including your personal identifying information, may be made publicly available at any time. While you can ask us in your comment to withhold your personal identifying information from public view, we cannot guarantee that we will be able to do so.

    Authority

    We provide this notice under section 10 of the ESA (16 U.S.C. 1531 et seq.) and NEPA regulations (40 CFR 1506.6).

    Dated: November 13, 2018. Stephen P. Henry, Field Supervisor, Ventura Fish and Wildlife Office, Ventura, California.
    [FR Doc. 2018-25397 Filed 11-20-18; 8:45 am] BILLING CODE 4333-15-P
    DEPARTMENT OF THE INTERIOR Bureau of Indian Affairs [190A2100DD/AAKC001030/A0A501010.999900 253G] Draft Environmental Impact Statement for the Little River Band Trust Acquisition and Casino Project, Township of Fruitport, Muskegon County, Michigan AGENCY:

    Bureau of Indian Affairs, Interior.

    ACTION:

    Notice of availability.

    SUMMARY:

    This notice advises the public that the Bureau of Indian Affairs (BIA) as lead agency, with the Township of Fruitport, County of Muskegon, Little River Band of Ottawa Indians (Tribe), Federal Highway Administration, and the U.S. Environmental Protection Agency (EPA), serving as cooperating agencies, intends to file a Draft Environmental Impact Statement (DEIS) with the EPA in connection with the Tribe's application for transfer into trust by the United States of approximately 60 acres for gaming and other purposes to be located the Township of Fruitport, Muskegon County, Michigan. This notice also announces that the DEIS is now available for public review and that a public hearing will be held to receive comments on the DEIS.

    DATES:

    Written comments on the DEIS must arrive within 45 days after EPA publishes its Notice of Availability in the Federal Register. The date and location of the public hearing on the DEIS will be announced at least 15 days in advance through a notice to be published in local newspaper, The Muskegon Chronicle, and online at www.littlerivereis.com.

    ADDRESSES:

    You may mail or hand-deliver written comments to Mr. Timothy LaPointe, Midwest Regional Director, Bureau of Indian Affairs, Midwest Region, Norman Pointe II Building, 5600 West American Boulevard, Suite 500, Bloomington, Minnesota 55347. Please include your name, return address, and the caption: “DEIS Comments, Little River Band Trust Acquisition and Casino Project,” on the first page of your written comments. See the SUPPLEMENTARY INFORMATION section of this notice for addresses where the DEIS is available for review.

    FOR FURTHER INFORMATION CONTACT:

    Mr. Felix Kitto, Regional Environmental Protection Specialist, Division of Environmental, Facilities, Safety and Cultural Resource Management (DEFSCRM), Bureau of Indian Affairs, Midwest Region, Norman Pointe II Building, 5600 West American Boulevard, Suite 500, Bloomington, Minnesota 55347; phone: (612) 725-4597; email: [email protected]. Information is also available online at www.littlerivereis.com.

    SUPPLEMENTARY INFORMATION:

    Public review of the DEIS is part of the administrative process for the evaluation of the Tribe's application to the BIA for the Federal trust acquisition of approximately 60 acres in the Township of Fruitport, Muskegon County, Michigan, upon which the Tribe proposes to develop a casino, hotel, parking, and other supporting facilities. A Notice of Intent was published in the Federal Register on September 21, 2015, as well as published in The Muskegon Chronicle. The BIA held a public scoping meeting for the project on October 15, 2015, at Fruitport Middle School, 3113 East Pontaluna Road, Fruitport, Michigan 49415.

    Background: The Tribe's Proposed Project consists of the following components: (1) The transfer of an approximately 60-acre property from fee to trust status; (2) issuance of a Secretarial Determination by the Secretary of the Interior (Secretary) under Section 20 of the Indian Gaming Regulatory Act (IGRA) that gaming on the project site would be in the best interest of the Tribe and not detrimental to the surrounding community (25 U.S.C. 2719 (b)(1)(A)); and (3) development of the trust parcel and adjacent land owned by the Tribe, totaling approximately 86.5 acres, with a variety of uses including a casino, hotel, conference center, parking, and other supporting facilities. The proposed casino-hotel resort would include a hotel, a convention center, several restaurant facilities, and parking facilities. Access to the project site would be provided via two driveways: One along Harvey Street and one along East Ellis Road. Five service driveways, not for public use, would be located on East Ellis Road.

    The following alternatives are considered in the DEIS: (1) Proposed Project; (2) Reduced Intensity Alternative; (3) Non-Gaming Alternative; (4) Custer Site Alternative and (5) No Action/No Development. Environmental issues addressed in the DEIS include geology and soils, water resources, air quality, biological resources, cultural and paleontological resources, socioeconomic conditions (including environmental justice), transportation and circulation, land use, public services, noise, hazardous materials, aesthetics, cumulative effects, and indirect and growth-inducing effects.

    Locations where the DEIS is available for review: The DEIS will be available for review at the Fruitport Public Library located at 47 Park St., Fruitport, Michigan 49415, and online at www.littlerivereis.com. To obtain a compact disk copy of the DEIS, please provide your name and address in writing to Mr. Felix Kitto, Bureau of Indian Affairs, Midwest Regional Office. Contact information is listed in the FOR FURTHER INFORMATION CONTACT section of this notice. Individual paper copies of the DEIS will be provided only upon payment of applicable printing expenses by the requestor for the number of copies requested.

    Public comment availability: Comments, including names and addresses of respondents, will be available for public review at the BIA address shown in the ADDRESSES section, during regular business hours, 8 a.m. to 4:30 p.m., Monday through Friday, except holidays. Before including your address, phone number, email address, or other personal identifying information in your comment, you should be aware that your entire comment—including your personal identifying information—may be made publicly available at any time. While you can ask in your comment that your personal identifying information be withheld from public review, the BIA cannot guarantee that this will occur.

    Authority:

    This notice is published pursuant to Sec. 1503.1 of the Council of Environmental Quality Regulations (40 CFR parts 1500 through 1508) and Sec. 46.305 of the Department of the Interior Regulations (43 CFR part 46), implementing the procedural requirements of the NEPA of l969, as amended (42 U.S.C. 4371, et seq.), and is in the exercise of authority delegated to the Assistant Secretary—Indian Affairs by 209 DM 8.

    Dated: November 9, 2018. Tara Sweeney, Assistant Secretary—Indian Affairs.
    [FR Doc. 2018-25411 Filed 11-20-18; 8:45 am] BILLING CODE 4337-15-P
    DEPARTMENT OF THE INTERIOR Bureau of Indian Affairs [190A2100DD/A0A501010.999900 253G] Notice of Intent To Prepare an Environmental Impact Statement for the Proposed Campo Wind Energy Project, San Diego, California AGENCY:

    Bureau of Indian Affairs, Interior.

    ACTION:

    Notice of intent.

    SUMMARY:

    This notice advises the public that the Bureau of Indian Affairs (BIA), as lead agency, with the Campo Band of Diegueno Mission Indians of the Campo Indian Reservation (Tribe) as a cooperating agency, intends to gather information necessary for preparing an Environmental Impact Statement (EIS) for the proposed Campo Wind Project, located on the Campo Indian Reservation (Reservation) in southeastern San Diego County, approximately 60 miles east of San Diego, California. Construction of the Campo Wind Project is subject to BIA approval of a lease and sublease, which, as proposed, is a major Federal action under the National Environmental Policy Act of 1969 (NEPA), as amended. A brief description of the proposed action is provided below in the SUPPLEMENTARY INFORMATION section. This notice also announces a public scoping meeting to identify potential issues, concerns, and alternatives to be considered in the EIS. The scoping process will include notice to the public and Federal, State, local, and Tribal agencies of the proposed action.

    DATES:

    Written comments on the scope and implementation of this proposal must arrive by 11:59 p.m. on December 21, 2018. The date and location of the public hearing on the EIS will be announced at least 15 days in advance through a notice to be published in local newspapers (The San Diego Union Tribune and The San Diego Business Journal) and online at: www.campowind.com.

    ADDRESSES:

    The public may mail or hand-carry written comments to Ms. Amy Dutschke, Regional Director, Bureau of Indian Affairs, 2800 Cottage Way, Sacramento, California 95825. You may also submit comments through email to Mr. Dan (Harold) Hall, Acting Chief, Division of Environmental, Cultural Resource Management and Safety, Bureau of Indian Affairs, at [email protected]. More information can be found in the SUPPLEMENTARY INFORMATION section of this notice.

    Please include the commenter's name, title, return address, and “EIS Scoping Comments, Campo Wind Project, San Diego County, California,” on the first page of the written comments. The scoping meeting will be held at Campo Indian Reservation Tribal Hall, 36190 Church Road (BIA Road 10), Campo, California 91906.

    FOR FURTHER INFORMATION CONTACT:

    Mr. Dan (Harold) Hall Acting Chief, Division of Environmental, Cultural Resource Management and Safety, Bureau of Indian Affairs, by telephone at (916) 978-6041, or by email at [email protected].

    SUPPLEMENTARY INFORMATION: Project Description

    BIA approval is required for a lease and sublease to build and operate a commercial wind power generation facility capable of generating up to 252 megawatts (MW) of electricity.

    The project would include the generation of up to 252 MW consisting of up to 60 turbines. The project study area covers approximately 2,200 acres on the Campo Indian Reservation. The total area that would be disturbed by the project would be substantially less. The turbines proposed for the project would range from 2.5 MW to 4.2 MW in maximum output rating per turbine, tubular steel towers, with a rotor diameter of approximately 450 feet, a hub height of approximately 361 feet, and a total height of turbine (highest point) of approximately 586 feet. Each turbine would be set on a concrete foundation. Turbines would be connected by an underground electrical collection system to a project collector substation. The collector substation would be sited on approximately 2 acres and would consist of a graveled, fenced area containing transformer and switching equipment and an area for vehicle parking. A new 230 kV overhead generation transmission line would be constructed, on the Campo Indian Reservation and partially outside on private lands, from the project collector substation on the Reservation to a San Diego Gas & Electric (SDG&E) substation/switchyard that would be constructed on private lands adjacent to the Sunrise Powerlink northeast of the Reservation. The SDG&E substation/switchyard and related transmission line improvements will be subject to approval by the County of San Diego, California, Public Utilities Commission (CPUC) and the BIA. Other required facilities, all located within the Reservation, would include: Up to three permanent meteorological towers; temporary material laydown areas during construction; temporary staging and construction trailer areas; an operations and maintenance building; underground cabling; telecommunications; new access roads and improvements to portions of existing roads; and a temporary concrete batch plant. The wind power generation facility would operate year-round for a minimum of 25 years.

    The EIS will analyze the potential environmental impacts of the construction and operation of a proposed wind generation facility, including access roads, a collector substation, as well as a substation/switchyard and transmission facilities. The EIS will be prepared in accordance with NEPA (42 U.S.C. 4321 et seq.); the Council on Environmental Quality (CEQ) regulations (40 CFR parts 1500-1508); Department of the Interior regulations (43 CFR part 46); and the BIA NEPA Handbook (59 IAM 3-H) and will also be compliant with the California Environmental Quality Act in accordance with Public Resources Code section 21083.7. A reasonable range of alternatives to the proposed action including a no-action alternative, will be analyzed in the EIS. The range of issues and alternatives included will be based on comments and information received during the scoping process. This notice initiates the public scoping process to identify alternatives and relevant issues associated with the proposed project.

    Directions for Submitting Public Comments

    During the public scoping meetings, the public may submit written and verbal comments. Verbal comments given at the scoping meetings will have the same merit as written comments and will be addressed equally. The public may mail or hand-carry written comments to Ms. Amy Dutschke, Regional Director, Bureau of Indian Affairs, 2800 Cottage Way, Sacramento, California 95825. Please include the commenter's name, title, return address and “EIS Scoping Comments, Campo Wind Project, San Diego County, California,” on the first page of the written comments.

    Public Availability of Comments

    Comments, including names and addresses of respondents, will be available for public review at the BIA address shown in the ADDRESSES section of this notice, during business hours, 8 a.m. to 4:30 p.m., Monday through Friday, except holidays. Individual respondents may request confidentiality. If a commenter wishes us to withhold commenter's name and/or address from public review or from disclosure under the Freedom of Information Act, the commenter must state this prominently at the beginning of the written comment. Such requests will be honored to the extent allowed by the law, however there is a possibility that the comment(s) may be made publicly available at any time.

    Authority

    This notice is published in accordance with sections 1501.7 (Scoping), 1506.6 (Public involvement), and 1508.22 (Notice of Intent) of the CEQ Regulations (40 CFR parts 1500 through 1508) and section 46.305 of the Department of the Interior Regulations (43 CFR part 46), implementing the procedural requirements of NEPA, as amended (42 U.S.C. 4321 et seq.), and is in the exercise of authority delegated to the Assistant Secretary—Indian Affairs by 209 DM 8.

    Dated: November 9, 2018. Tara Sweeney, Assistant Secretary—Indian Affairs.
    [FR Doc. 2018-25412 Filed 11-20-18; 8:45 am] BILLING CODE 4337-15-P
    DEPARTMENT OF THE INTERIOR Bureau of Land Management [19X.LLAK930000.L13100000.DS0000] Notice of Intent To Prepare an Integrated Activity Plan and Environmental Impact Statement for the National Petroleum Reserve in Alaska AGENCY:

    Bureau of Land Management, Interior.

    ACTION:

    Notice of intent.

    SUMMARY:

    In accordance with the Naval Petroleum Reserves Production Act of 1976, as amended, the Bureau of Land Management (BLM) Alaska State Office, Anchorage, Alaska, intends to prepare a new Integrated Activity Plan and Environmental Impact Statement (IAP/EIS) for BLM-managed lands within the National Petroleum Reserve in Alaska (NPR-A). By this notice, the BLM is announcing the beginning of the Environmental Impact Statement (EIS) scoping process to solicit public comments and identify issues.

    DATES:

    Comments on relevant issues that will influence the scope of the EIS for the NPR-A IAP/EIS project may be submitted in writing until January 7, 2019. The BLM will also provide opportunities for public participation during scoping meetings with appropriate public notice. The date(s) and location(s) of scoping meetings will be announced in advance through local media, newspapers, and the BLM website at: www.blm.gov/alaska.

    In order to be considered for the Draft IAP/EIS, all comments must be received prior to the close of the 45-day scoping period. Federal, State or local agencies, or tribes who are interested in serving as a cooperating agency for the development of the IAP/EIS are asked to submit such requests to the BLM.

    ADDRESSES:

    You may submit comments on issues related to the proposed NPR-A IAP/EIS project by any of the following methods:

    Online: http://www.blm.gov/alaska/NPR-A-IAP-EIS.

    Fax: (907) 271-5479.

    Mail: NPR-A IAP/EIS Scoping Comments, 222 West 7th Avenue, Mailstop #13, Anchorage, AK 99513.

    The 2013 IAP/EIS ROD can be downloaded from the BLM's website at www.blm.gov/alaska, and you can view hard copies at the BLM Alaska Public Information Center (“Public Room”), Arctic District Office, 222 University Avenue, Fairbanks, Alaska, and at the BLM Alaska Public Information Center (“Public Room”), Alaska State Office, 222 West 8th Avenue, Anchorage, Alaska.

    FOR FURTHER INFORMATION CONTACT:

    Stephanie Rice; Planning and Environmental Coordinator, 907-271-3202, [email protected]. You may also request to be added to the mailing list. People who use a telecommunications device for the deaf (TDD) may call the Federal Relay Service (FRS) at 1-800-877-8339 to contact the above individual during normal business hours. The FRS is available 24 hours a day, seven days a week, to leave a message or question with the above individual. You will receive a reply during normal business hours.

    SUPPLEMENTARY INFORMATION:

    This notice initiates the public scoping process for the EIS. Comments regarding management decisions, resources to be addressed, and issues for analysis will assist the BLM in defining the proposed actions and alternatives for the NPR-A IAP/EIS.

    The Naval Petroleum Reserves Production Act (42 U.S.C. 6501), as amended, excludes the NPR-A from the application of Section 202 of the Federal Land Policy and Management Act (43 U.S.C. 1701), as amended, which is the basis for the BLM's Resource Management Plans. The BLM conducts planning within the NPR-A with an IAP. The BLM complies with all applicable laws in the preparation of the IAP, including the National Environmental Policy Act, the Endangered Species Act, Marine Mammal Protection Act, and the National Historic Preservation Act.

    Purpose and Need for Action

    The BLM is developing a new IAP/EIS to determine the appropriate management of all BLM-managed lands in the NPR-A in a manner consistent with existing statutory direction and Secretarial Order 3352. Secretarial Order 3352 directs the development of a schedule to “effectuate the lawful review and development of an IAP for the NPR-A that strikes an appropriate balance of promoting development while protecting surface resources.” The Naval Petroleum Reserves Production Act, as amended, and its implementing regulations require oil and gas leasing in the NPR-A and the protection of surface values consistent with exploration, development and transportation of oil and gas.

    Proposed Action

    The BLM will be preparing a new IAP/EIS, which is intended to supersede the 2013 IAP/EIS ROD and, depending on the alternative selected, may supersede the 2008 Colville River Special Area Management Plan, as amended by the 2013 IAP/EIS ROD.

    Lead and Cooperating Agencies

    The BLM is the lead agency for the IAP/EIS. The BLM has extended invitations to participate as cooperating agencies to the U.S. Fish and Wildlife Service, the National Marine Fisheries Service, the State of Alaska, the North Slope Borough, the National Park Service, the Bureau of Ocean Energy Management, and the U.S. Geological Survey.

    Responsible Official

    The Secretary of the Interior is the responsible official.

    Nature of Decision To Be Made

    Consistent with the Naval Petroleum Reserves Production Act, the IAP/EIS will address a narrower range of multiple use management than a resource management plan (e.g., it will not contemplate opening lands to hard rock or coal mining). The IAP/EIS will include: A consideration of a range of alternatives that make lands available for leasing; an examination of current special area boundaries; and, a consideration of new or revised lease stipulations and best management practices. The IAP/EIS would also ensure that the BLM's land management will provide the opportunity, subject to appropriate conditions developed through a National Environmental Policy Act (NEPA) process, to construct pipelines and other necessary infrastructure to bring oil and gas resources from offshore or adjacent leases to the Trans-Alaska Pipeline System or a future gas pipeline from the North Slope. The IAP/EIS would also consider the potential for a road system connecting communities across the North Slope.

    Scoping Process

    This notice of intent initiates the scoping process, which guides the development of the IAP/EIS. The purpose of the public scoping process is to determine the management decisions and resources to be addressed and the issues for analysis. The BLM will work collaboratively with interested parties to identify the management decisions best suited to local, regional, and national needs and concerns.

    The BLM must receive all comments by the end of the scoping comment period to be included in the scoping report. The most useful comments are substantive comments that address the following topics: Areas available for leasing, special area boundaries, lease stipulations and best management practices, and resource issues to be analyzed.

    You may submit written comments on management decisions, resources to be addressed, and issues for analysis to the BLM at any of the public scoping meetings, or you may use any of the methods listed in the ADDRESSES section above. Before including your address, phone number, email address, or other personal identifying information in your comment, you should be aware that your entire comment—including your personal identifying information—may be made publicly available at any time. Although you may ask the BLM to withhold your personal identifying information from public review, the BLM cannot provide any guarantees that it will be able to do so.

    Authority:

    40 CFR 1501.7.

    Ted A. Murphy, Acting State Director, Alaska.
    [FR Doc. 2018-25336 Filed 11-20-18; 8:45 am] BILLING CODE 4310-JA-P
    DEPARTMENT OF JUSTICE [OLP Docket No. 168] Supplemental Information Regarding Arizona Capital Counsel Mechanism AGENCY:

    Department of Justice.

    ACTION:

    Notice.

    SUMMARY:

    This notice advises the public that the State of Arizona has provided additional information about its capital counsel mechanism, and solicits public comment on that supplemental information.

    DATES:

    Written and electronic comments must be submitted on or before January 7, 2019. Comments received by mail will be considered timely if they are postmarked on or before that date. The electronic Federal Docket Management System (FDMS) will accept comments until Midnight Eastern Time at the end of that day.

    ADDRESSES:

    To ensure proper handling of comments, please reference “Docket No. OLP 168” on all electronic and written correspondence. The Department encourages that all comments be submitted electronically through http://www.regulations.gov using the electronic comment form provided on that site. Paper comments that duplicate the electronic submission should not be submitted. Individuals who wish to submit written comments may send those to the contact listed in the FOR FURTHER INFORMATION CONTACT section immediately below.

    FOR FURTHER INFORMATION CONTACT:

    Laurence Rothenberg, Deputy Assistant Attorney General, Office of Legal Policy, U.S. Department of Justice, 950 Pennsylvania Avenue NW, Washington, DC 20530; telephone (202) 532-4465.

    SUPPLEMENTARY INFORMATION:

    Chapter 154 of title 28, United States Code, provides special procedures for federal habeas corpus review of cases brought by prisoners in State custody who are subject to capital sentences. The special procedures may be available to a State only if the Attorney General of the United States has certified that the State has established a qualifying mechanism for the appointment, compensation, and payment of reasonable litigation expenses of competent counsel in State postconviction proceedings for indigent capital prisoners. 28 U.S.C. 2261, 2265; 28 CFR part 26.

    On November 16, 2017, the Department of Justice, Office of Legal Policy published a notice in the Federal Register, 82 FR 53529, advising the public of Arizona's request for certification, dated April 18, 2013, and requesting public comment regarding that request. The Department also sent a letter to Arizona, dated November 16, 2017, asking whether the State wished to supplement or update its request. Arizona responded in a letter dated November 27, 2017. The Department, on December 27, 2017, published a second notice in the Federal Register, 82 FR 61329, which advised the public that the State had submitted additional information and provided additional time for public comment.

    Following the receipt of public comments, the Department sent a letter dated June 29, 2018, to Arizona requesting that the State provide answers to a number of questions that had arisen during the Department's review of the comments, and inviting response to any other matters raised in the comments. This notice advises the public that the State of Arizona submitted additional information in response, in a letter dated October 16, 2018, and solicits public comment on that supplemental information. The correspondence with Arizona, including its letter of October 16, 2018, may be viewed at https://www.justice.gov/olp/pending-requests-final-decisions.

    Following the Department's transmission of its letter of June 29, 2018 to Arizona, and again following Arizona's transmission of its responsive letter of October 16, 2018 to the Department, a commenter on Arizona's request for certification requested that the Department provide an opportunity for additional public comment to allow response to the new information in Arizona's letter. This notice provides an opportunity for such public comment.

    Dated: November 13, 2018. Beth A. Williams, Assistant Attorney General.
    [FR Doc. 2018-25333 Filed 11-20-18; 8:45 am] BILLING CODE 4410-BB-P
    NATIONAL FOUNDATION ON THE ARTS AND THE HUMANITIES National Endowment for the Arts Arts Advisory Panel Meetings AGENCY:

    National Endowment for the Arts

    ACTION:

    Notice of meetings.

    SUMMARY:

    Pursuant to the Federal Advisory Committee Act, as amended, notice is hereby given that 6 meetings of the Arts Advisory Panel to the National Council on the Arts will be held by teleconference.

    DATES:

    See the SUPPLEMENTARY INFORMATION section for individual meeting times and dates. All meetings are Eastern time and ending times are approximate:

    ADDRESSES:

    National Endowment for the Arts, Constitution Center, 400 7th St. SW, Washington, DC 20506.

    FOR FURTHER INFORMATION CONTACT:

    Further information with reference to these meetings can be obtained from Ms. Sherry Hale, Office of Guidelines & Panel Operations, National Endowment for the Arts, Washington, DC 20506; [email protected], or call 202/682-5696.

    SUPPLEMENTARY INFORMATION:

    The closed portions of meetings are for the purpose of Panel review, discussion, evaluation, and recommendations on financial assistance under the National Foundation on the Arts and the Humanities Act of 1965, as amended, including information given in confidence to the agency. In accordance with the determination of the Chairman of July 5, 2016, these sessions will be closed to the public pursuant to subsection (c)(6) of section 552b of title 5, United States Code.

    The upcoming meetings are:

    Literature (review of applications): This meeting will be closed. Date and time: December 17, 2018; 1:00 p.m. to 3:00 p.m. Media Arts (review of applications): This meeting will be closed. Date and time: December 17, 2018; 2:30 p.m. to 4:30 p.m. Literature (review of applications): This meeting will be closed. Date and time: December 18, 2018; 1:00 p.m. to 3:00 p.m. Media Arts (review of applications): This meeting will be closed. Date and time: December 18, 2018; 11:30 a.m. to 1:30 p.m. Media Arts (review of applications): This meeting will be closed. Date and time: December 18, 2018; 2:30 p.m. to 4:30 p.m. Media Arts (review of applications): This meeting will be closed. Date and time: December 19, 2018; 11:30 a.m. to 1:30 p.m. Dated: November 16, 2018. Sherry Hale, Staff Assistant, National Endowment for the Arts.
    [FR Doc. 2018-25376 Filed 11-20-18; 8:45 am] BILLING CODE 7537-01-P
    NUCLEAR REGULATORY COMMISSION [NRC-2018-0236] Memorandum of Understanding Between the U.S. Nuclear Regulatory Commission and the Wyoming Department of Environmental Quality AGENCY:

    Nuclear Regulatory Commission.

    ACTION:

    Memorandum of understanding; issuance.

    SUMMARY:

    This notice is announcing that, effective on September 30, 2018, the U.S. Nuclear Regulatory Commission (NRC or Commission) and the State of Wyoming, Department of Environmental Quality (WYDEQ), entered into a Memorandum of Understanding (MOU) for the purpose of establishing a regulatory process for the completion of decommissioning of five uranium mill tailing sites and the termination of the associated uranium mill licenses located within the State of Wyoming.

    DATES:

    The MOU was issued on September 30, 2018.

    ADDRESSES:

    Please refer to Docket ID NRC-2018-0236 when contacting the NRC about the availability of information regarding this document. You may obtain publicly-available information related to this document using any of the following methods:

    • Federal Rulemaking website: Go to http://www.regulations.gov and search for Docket ID NRC-2018-0236. Address questions about dockets in Regulations.gov to Jennifer Borges; telephone: 301-287-9127; email: [email protected]. For technical questions, contact the individual listed in the FOR FURTHER INFORMATION CONTACT section of this document.

    • NRC's Agencywide Documents Access and Management System (ADAMS): You may obtain publicly available documents online in the ADAMS Public Document collection at http://www.nrc.gov/reading-rm/adams.html. To begin the search, select “Begin Web-based ADAMS Search.” For problems with ADAMS, contact the NRC's PDR reference staff at 1-800-397-4209, 301-415-4737, or by email to [email protected]. The “Memorandum of Understanding between the U.S. Nuclear Regulatory Commission and the Wyoming Department of Environmental Quality to Establish a Process for the Completion of Decommissioning of Five Uranium Mill Tailing Sites and the Termination of the Associated Uranium Mill Licenses Located within the State of Wyoming,” is available electronically in ADAMS under Accession Number ML18165A254.

    • NRC's Public Document Room (PDR): The public may examine and purchase copies of public documents at the NRC's PDR, Room O1 F21, One White Flint North, 11555 Rockville Pike, Rockville, Maryland 20852.

    FOR FURTHER INFORMATION CONTACT:

    Stephen Poy, Office of Nuclear Material Safety and Safeguards, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001; telephone 301-415-7135; email: [email protected].

    SUPPLEMENTARY INFORMATION:

    Effective September 30, 2018, the NRC and the WYDEQ (collectively referred to as the Agencies) entered into a MOU for the purpose of establishing a regulatory process for the completion of decommissioning of five uranium mill tailing sites and the termination of the associated uranium mill licenses located within the State of Wyoming. This MOU pertains to the Agencies' roles in the decommissioning and eventual termination of the license for the following five uranium mill sites:

    1. Anadarko Bear Creek located in Converse County, Wyoming (NRC License No. SUA-1310, Docket No. 040-08452) 2. Pathfinder Lucky Mc located in Fremont County, Wyoming (NRC License No. SUA-672, Docket No. 040-02259) 3. Western Nuclear Split Rock located approximately 2 miles from Jeffrey City, Wyoming (NRC License SUA-56, Docket No. 040-01162) 4. Umetco Minerals Corporation Gas Hills East located in Natrona, County Wyoming (NRC License No. SUA-648, Docket No. 040-00299) 5. ExxonMobil Highlands located approximately 25 miles north of Douglas, Wyoming (NRC License No. SUA-1139, Docket No. 040-08102)

    The five licenses were transferred to the State of Wyoming on September 30, 2018, when the NRC discontinued, and the State of Wyoming assumed, regulatory authority over the management and disposal of byproduct material as defined in 11e.(2) of the Atomic Energy Act of 1954, as amended (the Act), and a subcategory of source material or ores involved in the extraction or concentration of uranium or thorium milling in the State in accordance with the agreement authorized by Section 274b. of the Act (83 FR 48905; September 28, 2018). The MOU documents completed NRC actions related to the decommissioning process for each of the sites and delineates specific actions, on a site-by-site basis, that the NRC and the State of Wyoming will take to verify completion of the decommissioning and license termination for these sites. The MOU stipulates that any decision made by the NRC for the five uranium mill sites prior to the discontinuation of the NRC's regulatory authority in Wyoming will be appropriately recognized by the NRC as meeting all applicable standards and requirements when reviewing the Completion Review Report. A Completion Review Report is required to be submitted by the State of Wyoming to the NRC, prior to license termination of a uranium mill site, for review and approval to adequately ensure public health and safety. Upon termination of each license, the site may be transferred, customarily, to the U.S. Department of Energy for long-term care and surveillance.

    The NRC and WYDEQ will cooperate fully with each other to carry out this MOU and its intent of ensuring protection of public health, safety, and the environment in accordance with all governing laws and regulations.

    Dated at Rockville, Maryland, this 15th day of November, 2018.

    For the Nuclear Regulatory Commission.

    Daniel S. Collins, Director, Division of Materials Safety, Security, State, and Tribal Programs, Office of Nuclear Material Safety and Safeguards.
    [FR Doc. 2018-25367 Filed 11-20-18; 8:45 am] BILLING CODE 7590-01-P
    POSTAL REGULATORY COMMISSION [Docket No. CP2019-17] New Postal Products AGENCY:

    Postal Regulatory Commission.

    ACTION:

    Notice.

    SUMMARY:

    The Commission is noticing a recent Postal Service filing for the Commission's consideration concerning a negotiated service agreement. This notice informs the public of the filing, invites public comment, and takes other administrative steps.

    DATES:

    Comments are due: November 26, 2018.

    ADDRESSES:

    Submit comments electronically via the Commission's Filing Online system at http://www.prc.gov. Those who cannot submit comments electronically should contact the person identified in the FOR FURTHER INFORMATION CONTACT section by telephone for advice on filing alternatives.

    FOR FURTHER INFORMATION CONTACT:

    David A. Trissell, General Counsel, at 202-789-6820.

    SUPPLEMENTARY INFORMATION: Table of Contents I. Introduction II. Docketed Proceeding(s) I. Introduction

    The Commission gives notice that the Postal Service filed request(s) for the Commission to consider matters related to negotiated service agreement(s). The request(s) may propose the addition or removal of a negotiated service agreement from the market dominant or the competitive product list, or the modification of an existing product currently appearing on the market dominant or the competitive product list.

    Section II identifies the docket number(s) associated with each Postal Service request, the title of each Postal Service request, the request's acceptance date, and the authority cited by the Postal Service for each request. For each request, the Commission appoints an officer of the Commission to represent the interests of the general public in the proceeding, pursuant to 39 U.S.C. 505 (Public Representative). Section II also establishes comment deadline(s) pertaining to each request.

    The public portions of the Postal Service's request(s) can be accessed via the Commission's website (http://www.prc.gov). Non-public portions of the Postal Service's request(s), if any, can be accessed through compliance with the requirements of 39 CFR 3007.301.1

    1See Docket No. RM2018-3, Order Adopting Final Rules Relating to Non-Public Information, June 27, 2018, Attachment A at 19-22 (Order No. 4679).

    The Commission invites comments on whether the Postal Service's request(s) in the captioned docket(s) are consistent with the policies of title 39. For request(s) that the Postal Service states concern market dominant product(s), applicable statutory and regulatory requirements include 39 U.S.C. 3622, 39 U.S.C. 3642, 39 CFR part 3010, and 39 CFR part 3020, subpart B. For request(s) that the Postal Service states concern competitive product(s), applicable statutory and regulatory requirements include 39 U.S.C. 3632, 39 U.S.C. 3633, 39 U.S.C. 3642, 39 CFR part 3015, and 39 CFR part 3020, subpart B. Comment deadline(s) for each request appear in section II.

    II. Docketed Proceeding(s)

    1. Docket No(s).: CP2019-17; Filing Title: Notice of United States Postal Service of Filing a Functionally Equivalent Global Expedited Package Services 9 Negotiated Service Agreement and Application for Non-Public Treatment of Materials Filed Under Seal; Filing Acceptance Date: November 15, 2018; Filing Authority: 39 CFR 3015.5; Public Representative: Curtis E. Kidd; Comments Due: November 26, 2018.

    This Notice will be published in the Federal Register.

    Stacy L. Ruble, Secretary.
    [FR Doc. 2018-25377 Filed 11-20-18; 8:45 am] BILLING CODE 7710-FW-P
    SECURITIES AND EXCHANGE COMMISSION [Release No. 34-84604; File No. SR-CboeBZX-2018-077] Self-Regulatory Organizations; Cboe BZX Exchange, Inc.; Notice of Filing of a Proposed Rule Change To List and Trade Shares of the JPMorgan Inflation Managed Bond ETF of the J.P. Morgan Exchange-Traded Fund Trust Under Rule 14.11(i), Managed Fund Shares November 15, 2018.

    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (“Act”),1 and Rule 19b-4 thereunder,2 notice is hereby given that on November 2, 2018, Cboe BZX Exchange, Inc. (“Exchange” or “BZX”) filed with the Securities and Exchange Commission (“Commission”) the proposed rule change as described in Items I and II below, which Items have been prepared by the Exchange. The Commission is publishing this notice to solicit comments on the proposed rule change from interested persons.

    1 15 U.S.C. 78s(b)(1).

    2 17 CFR 240.19b-4.

    I. Self-Regulatory Organization's Statement of the Terms of Substance of the Proposed Rule Change

    The Exchange filed a proposal to list and trade shares of the JPMorgan Inflation Managed Bond ETF (the “Fund”) of the J.P. Morgan Exchange-Traded Fund Trust (the “Trust” or the “Issuer”) under Rule 14.11(i) (“Managed Fund Shares”). The shares of the Fund are referred to herein as the “Shares.”

    The text of the proposed rule change is also available on the Exchange's website (http://www.cboe.com/AboutCBOE/CBOELegalRegulatoryHome.aspx), at the Exchange's Office of the Secretary, and at the Commission's Public Reference Room.

    II. Self-Regulatory Organization's Statement of the Purpose of, and Statutory Basis for, the Proposed Rule Change

    In its filing with the Commission, the Exchange included statements concerning the purpose of and basis for the proposed rule change and discussed any comments it received on the proposed rule change. The text of these statements may be examined at the places specified in Item IV below. The Exchange has prepared summaries, set forth in sections A, B, and C below, of the most significant aspects of such statements.

    A. Self-Regulatory Organization's Statement of the Purpose of, and Statutory Basis for, the Proposed Rule Change 1. Purpose

    The Exchange proposes to list and trade the Shares under Rule 14.11(i), which governs the listing and trading of Managed Fund Shares on the Exchange.3 The Fund will be an actively managed exchange-traded fund that seeks to maximize inflation protected total return. The Exchange submits this proposal in order to allow the Fund to hold Inflation Swaps and Other Derivatives, as each is defined below, in a manner that may not comply with Rule 14.11(i)(4)(C)(iv)(a),4 Rule 14.11(i)(4)(C)(iv)(b),5 and/or Rule 14.11(i)(4)(C)(v),6 as further described below.7 Otherwise, the Fund will comply with all other listing requirements on an initial and continued listing basis under Rule 14.11(i).

    3 The Commission originally approved BZX Rule 14.11(i) in Securities Exchange Act Release No. 65225 (August 30, 2011), 76 FR 55148 (September 6, 2011) (SR-BATS-2011-018) and subsequently approved generic listing standards for Managed Fund Shares under Rule 14.11(i) in Securities Exchange Act Release No. 78396 (July 22, 2016), 81 FR 49698 (July 28, 2016) (SR-BATS-2015-100).

    4 Rule 14.11(i)(4)(C)(iv)(a) provides that “there shall be no limitation to the percentage of the portfolio invested in such holdings; provided, however, that in the aggregate, at least 90% of the weight of such holdings invested in futures, exchange-traded options, and listed swaps shall, on both an initial and continuing basis, consist of futures, options, and swaps for which the Exchange may obtain information via the Intermarket Surveillance Group (“ISG”) from other members or affiliates of the ISG or for which the principal market is a market with which the Exchange has a comprehensive surveillance sharing agreement, calculated using the aggregate gross notional value of such holdings.” The Exchange is proposing that the Fund be exempt from this requirement only as it relates to the Fund's holdings in certain credit default swaps, interest rate swaps, and Inflation Swaps, as further described below.

    5 Rule 14.11(i)(4)(C)(iv)(b) provides that “the aggregate gross notional value of listed derivatives based on any five or fewer underlying reference assets shall not exceed 65% of the weight of the portfolio (including gross notional exposures), and the aggregate gross notional value of listed derivatives based on any single underlying reference asset shall not exceed 30% of the weight of the portfolio (including gross notional exposures).” The Exchange is proposing that the Fund would meet neither the 65% nor the 30% requirements of Rule 14.11(i)(4)(C)(iv)(b). Specifically, the Exchange is proposing that the Fund be exempt from this requirement as it relates to the Fund's holdings in listed derivatives, which include U.S. Treasury futures, Eurodollar futures, options on U.S. Treasuries and Treasury futures, credit default swaps, and certain Inflation Swaps and interest rate swaps, as further described below, which could constitute as much as 100% of the weight of the portfolio (including gross notional exposures) based on a single underlying reference asset.

    6 Rule 14.11(i)(4)(C)(v) provides that “the portfolio may, on both an initial and continuing basis, hold OTC derivatives, including forwards, options, and swaps on commodities, currencies and financial instruments (e.g., stocks, fixed income, interest rates, and volatility) or a basket or index of any of the foregoing, however the aggregate gross notional value of OTC derivatives shall not exceed 20% of the weight of the portfolio (including gross notional exposures).” The Exchange is proposing that the Fund be exempt from this requirement as it relates to the Fund's holdings in OTC derivatives, which could constitute as much as 75% of the weight of the portfolio (including gross notional exposures).

    7 The Adviser, as defined below, notes that the Fund may by virtue of its holdings be issued certain equity instruments (“Equity Holdings”) that may not meet the requirements of Rule 14.11(i)(4)(C)(i). The Fund will not purchase such instruments and will dispose of such holdings as the Adviser determines is in the best interest of the Fund's shareholders. Such holdings will not constitute more than 10% of the Fund's net assets. The Adviser expects that the Fund will generally acquire such instruments through issuances that it receives by virtue of its other holdings, such as corporate actions or convertible securities.

    The Fund will be an actively managed fund. The Shares will be offered by the Trust, which was established as a Delaware statutory trust. J.P Morgan Investment Management, Inc. is the investment adviser (the “Adviser”) and the administrator (“Administrator”) to the Fund. JPMorgan Chase Bank, N.A. is the custodian and transfer agent (“Custodian” and “Transfer Agent,” respectively) for the Trust. JPMorgan Distribution Services, Inc. serves as the distributor (“Distributor”) for the Trust. The Trust is registered with the Commission as an open-end investment company and has filed a registration statement on behalf of the Fund on Form N-1A (“Registration Statement”) with the Commission.8

    8See Registration Statement on Form N-1A for the Trust, dated July 31, 2018 (File Nos. 333-191837 and 811-22903). The descriptions of the Fund and the Shares contained herein are based, in part, on information in the Registration Statement. The Commission has issued an order granting certain exemptive relief to the Trust under the Investment Company Act of 1940 (15 U.S.C. 80a-1) (“1940 Act”) (the “Exemptive Order”). Investment Company Act Release No. 31990 (February 9, 2016) (File No. 811-22903).

    Rule 14.11(i)(7) provides that, if the investment adviser to the investment company issuing Managed Fund Shares is affiliated with a broker-dealer, such investment adviser shall erect and maintain a “fire wall” between the investment adviser and the broker-dealer with respect to access to information concerning the composition and/or changes to such investment company portfolio.9 In addition, Rule 14.11(i)(7) further requires that personnel who make decisions on the investment company's portfolio composition must be subject to procedures designed to prevent the use and dissemination of material nonpublic information regarding the applicable investment company portfolio. Rule 14.11(i)(7) is similar to Rule 14.11(b)(5)(A)(i), however, Rule 14.11(i)(7) in connection with the establishment of a “fire wall” between the investment adviser and the broker-dealer reflects the applicable open-end fund's portfolio, not an underlying benchmark index, as is the case with index-based funds. The Adviser is not a registered broker-dealer, but is affiliated with multiple broker-dealers and has implemented and will maintain “fire walls” with respect to such broker-dealers regarding access to information concerning the composition and/or changes to the Fund's portfolio. In addition, Adviser personnel who make decisions regarding the Fund's portfolio are subject to procedures designed to prevent the use and dissemination of material nonpublic information regarding the Fund's portfolio. In the event that (a) the Adviser becomes registered as a broker-dealer or newly affiliated with another broker-dealer, or (b) any new adviser or sub-adviser is a registered broker-dealer or becomes affiliated with a broker-dealer, it will implement and maintain a fire wall with respect to its relevant personnel or such broker-dealer affiliate, as applicable, regarding access to information concerning the composition and/or changes to the portfolio, and will be subject to procedures designed to prevent the use and dissemination of material non-public information regarding such portfolio.

    9 An investment adviser to an open-end fund is required to be registered under the Investment Advisers Act of 1940 (the “Advisers Act”). As a result, the Adviser and its related personnel are subject to the provisions of Rule 204A-1 under the Advisers Act relating to codes of ethics. This Rule requires investment advisers to adopt a code of ethics that reflects the fiduciary nature of the relationship to clients as well as compliance with other applicable securities laws. Accordingly, procedures designed to prevent the communication and misuse of non-public information by an investment adviser must be consistent with Rule 204A-1 under the Advisers Act. In addition, Rule 206(4)-7 under the Advisers Act makes it unlawful for an investment adviser to provide investment advice to clients unless such investment adviser has (i) adopted and implemented written policies and procedures reasonably designed to prevent violation, by the investment adviser and its supervised persons, of the Advisers Act and the Commission rules adopted thereunder; (ii) implemented, at a minimum, an annual review regarding the adequacy of the policies and procedures established pursuant to subparagraph (i) above and the effectiveness of their implementation; and (iii) designated an individual (who is a supervised person) responsible for administering the policies and procedures adopted under subparagraph (i) above.

    The Fund intends to qualify each year as a regulated investment company under Subchapter M of the Internal Revenue Code of 1986, as amended.

    JPMorgan Inflation Managed Bond ETF

    According to the Registration Statement, the Fund will be an actively managed exchange-traded fund that will seek to maximize inflation protected total return. The Fund is designed to protect the total return generated by its fixed income holdings from inflation risk. Total return includes income and capital appreciation. The Fund seeks to achieve its investment objective by investing, under Normal Market Conditions,10 at least 80% of its net assets in Bonds,11 Inflation Hedging Instruments, and Other Derivatives, as defined below. The Fund will gain exposure to U.S. dollar-denominated bonds primarily through investing directly in Bonds. Up to 10% of the Fund's total assets may be invested in securities rated below investment grade (junk bonds). Junk bonds are rated in the fifth or lower rated categories (for example, BB+ or lower by Standard & Poor's Ratings Services and Ba1 or lower by Moody's). The Fund may also use the following instruments to gain exposure to credit or interest rates: credit default swaps,12 interest rate swaps,13 Eurodollar futures,14 U.S. Treasury futures,15 options on U.S. Treasury Futures,16 and options on U.S. Treasuries 17 (collectively, “Other Derivatives”).

    10 As defined in Rule 14.11(i)(3)(E), the term “Normal Market Conditions” includes, but is not limited to, the absence of trading halts in the applicable financial markets generally; operational issues causing dissemination of inaccurate market information or system failures; or force majeure type events such as natural or man-made disaster, act of God, armed conflict, act of terrorism, riot or labor disruption, or any similar intervening circumstance.

    11 For purposes of this proposal, the term “Bond” includes only the following U.S. dollar denominated instruments issued by the U.S. Government or its agencies and instrumentalities, a domestic or a foreign corporation or a municipality: corporate bonds, U.S. government and agency debt securities (excluding Treasury Inflation Protected Securities (“TIPS”), which, as described below, may be held by the Fund in order to attempt to mitigate inflation risk), asset-backed securities, and mortgage-related and mortgage-backed securities. Mortgage-related and mortgage-backed securities may be structured as collateralized mortgage obligations (agency and non-agency), stripped mortgage-backed securities (interest-only or principal-only), commercial mortgage-backed securities, mortgage pass-through securities, collateralized mortgage obligations, adjustable rate mortgages, convertible bonds and zero-coupon obligations. The Exchange notes that the Fund's holdings in Bonds will meet the requirements of Rule 14.11(i)(4)(C)(ii)(a)-(e) related to the fixed income securities portion of the Fund, including the requirement that non-agency, non-GSE, and privately-issued mortgage-related and other asset-backed securities components of a portfolio shall not account, in the aggregate, for more than 20% of the weight of the fixed income portion of the portfolio. The Fund will generally hold investment-grade Bonds, but may hold up to 10% of its net assets in Bonds that are not investment-grade at the time of purchase.

    12See supra notes 4 and 5. Credit default swaps held by the Fund will be traded on a U.S. Swap Execution Facility registered with the Commodity Futures Trading Commission. The Fund may hold up to 10% of its net assets in credit default swaps that are not investment-grade at the time of purchase.

    13See supra notes 4, 5, and 6. Interest rate swaps held by the Fund may include listed swaps, centrally cleared OTC swaps, or non-cleared OTC swaps. The Fund will attempt to limit counterparty risk in non-listed and non-cleared OTC swap contracts by entering into such contracts only with counterparties the Adviser believes are creditworthy and by limiting the Fund's exposure to each counterparty. The Adviser will monitor the creditworthiness of each counterparty and the Fund's exposure to each counterparty on an ongoing basis. To the extent that the Fund holds listed interest rate swaps, all such listed swaps held by the Fund will be traded on a U.S. Swap Execution Facility registered with the Commodity Futures Trading Commission.

    14See supra note 5.

    15See supra note 5.

    16See supra note 5.

    17See supra notes 4, 5, and 6. Options on U.S. Treasuries held by the Fund may include listed or OTC options. The Fund will attempt to limit counterparty risk in non-listed and non-cleared OTC options contracts by entering into such contracts only with counterparties the Adviser believes are creditworthy and by limiting the Fund's exposure to each counterparty. The Adviser will monitor the creditworthiness of each counterparty and the Fund's exposure to each counterparty on an ongoing basis.

    The Fund will attempt to mitigate the inflation risk of the Fund's exposure to Bonds primarily through the use of either OTC or listed inflation swaps (“Inflation Swaps”),18 which are managed on an active basis. Additionally, the Fund may also attempt to mitigate inflation risk through investing in TIPS (collectively, with Inflation Swaps, “Inflation Hedging Instruments”). The Exchange is proposing to allow the Fund to hold up to 100% of the weight of its portfolio (including gross notional exposure) in Inflation Swaps and Other Derivatives, collectively, in a manner that may not comply with Rules 14.11(i)(4)(C)(iv)(a),19 14.11(i)(4)(C)(iv)(b),20 and/or 14.11(i)(4)(C)(v).21

    18See supra notes 4, 5, and 6. The Fund will attempt to limit counterparty risk in non-listed and non-cleared OTC swap contracts by entering into such contracts only with counterparties the Adviser believes are creditworthy and by limiting the Fund's exposure to each counterparty. The Adviser will monitor the creditworthiness of each counterparty and the Fund's exposure to each counterparty on an ongoing basis. To the extent that the Fund holds listed Inflation Swaps, all such listed Inflation Swaps held by the Fund will be traded on a U.S. Swap Execution Facility registered with the Commodity Futures Trading Commission. Inflation Swaps held by the Fund will reference the Consumer Price Index For All Urban Consumers (CPI-U).

    19See supra note 4.

    20See supra note 5.

    21See supra note 6.

    The Fund's investments, including derivatives, will be consistent with the 1940 Act and the Fund's investment objective and policies and will not be used to enhance leverage (although certain derivatives and other investments may result in leverage).22 That is, while the Fund will be permitted to borrow as permitted under the 1940 Act, the Fund's investments will not be used to seek performance that is the multiple or inverse multiple (i.e., 2Xs and 3Xs) of the Fund's primary broad-based securities benchmark index (as defined in Form N-1A). The Fund will only use those derivatives included in the defined terms Inflation Swaps and Other Derivatives. The Fund's use of derivative instruments will be collateralized. In addition to the use described above, the Fund will also use derivative holdings for efficient portfolio management, profit and gain for the Fund, interest rate hedging, and managing credit risk.

    22 The Fund will include appropriate risk disclosure in its offering documents, including leveraging risk. Leveraging risk is the risk that certain transactions of a fund, including a fund's use of derivatives, may give rise to leverage, causing a fund to be more volatile than if it had not been leveraged. The Fund's investments in derivative instruments will be made in accordance with the 1940 Act and consistent with the Fund's investment objective and policies. To mitigate leveraging risk, the Fund will segregate or earmark liquid assets determined to be liquid by the Adviser in accordance with procedures established by the Trust's Board and in accordance with the 1940 Act (or, as permitted by applicable regulations, enter into certain offsetting positions) to cover its obligations under derivative instruments. These procedures have been adopted consistent with Section 18 of the 1940 Act and related Commission guidance. See 15 U.S.C. 80a-18; Investment Company Act Release No. 10666 (April 18, 1979), 44 FR 25128 (April 27, 1979); Dreyfus Strategic Investing, Commission No-Action Letter (June 22, 1987); Merrill Lynch Asset Management, L.P., Commission No-Action Letter (July 2, 1996).

    Other Investments

    Under Normal Market Conditions, the Fund may also invest up to 20% of its net assets in the following: One or more ETFs,23 money market mutual funds, including affiliated money market mutual funds, bank obligations, common and preferred stock, convertible securities (including contingent convertible securities), loan assignment and participations, commitments to purchase loan assignments, auction rate securities, commercial paper, common stock warrants and rights, custodial receipts, inverse floating rate instruments, non-ETF investment company securities, securities issued by real estate investment trusts, repurchase and reverse repurchase agreements, short-term funding agreements, structured investments, synthetic variable rate instruments, trust preferred securities, when-issued securities, delayed delivery securities, forward commitments, pay-in-kind securities, and deferred payment securities (collectively, excluding ETFs, “20% OTC Instruments”). The Fund may also engage in securities lending.

    23 For purposes of this proposal, the term “ETF” includes Portfolio Depositary Receipts, Index Fund Shares, and Managed Fund Shares as defined in Rule 14.11(b), (c), and (i), respectively, and their equivalents on other national securities exchanges.

    The Exchange represents that, except for the exceptions to BZX Rule 14.11(i)(4)(C) described above, the Fund's proposed investments will satisfy, on an initial and continued listing basis, all of the generic listing standards under BZX Rule 14.11(i)(4)(C) (the “Generic Listing Rules”) and all other applicable requirements for Managed Fund Shares under Rule 14.11(i). The Trust is required to comply with Rule 10A-3 under the Act for the initial and continued listing of the Shares of the Fund. In addition, the Exchange represents that the Shares of the Fund will comply with all other requirements applicable to Managed Fund Shares including, but not limited to, requirements relating to the dissemination of key information such as the Disclosed Portfolio, net asset value (“NAV”), and the Intraday Indicative Value, rules governing the trading of equity securities, trading hours, trading halts, surveillance, firewalls, and the information circular, as set forth in Exchange rules applicable to Managed Fund Shares and the orders approving such rules. At least 100,000 Shares will be outstanding upon the commencement of trading.

    Moreover, all of the ETFs, futures contracts, and listed options contracts, and certain of the Equity Holdings held by the Fund will trade on markets that are a member of ISG or affiliated with a member of ISG or with which the Exchange has in place a comprehensive surveillance sharing agreement.24 Additionally, the Exchange or FINRA, on behalf of the Exchange, are able to access, as needed, trade information for certain fixed income instruments reported to FINRA's Trade Reporting and Compliance Engine (“TRACE”) and municipal securities reported to the Municipal Securities Rulemaking Board's (the “MSRB”) Electronic Municipal Market Access system. FINRA also can access data obtained from the MSRB relating to municipal bond trading activity for surveillance purposes in connection with trading in the Shares. All statements and representations made in this filing regarding the description of the portfolio or reference assets, limitations on portfolio holdings or reference assets, dissemination and availability of index, reference asset, and intraday indicative values, and the applicability of Exchange rules specified in this filing shall constitute continued listing requirements for the Fund. The issuer has represented to the Exchange that it will advise the Exchange of any failure by the Fund or the Shares to comply with the continued listing requirements, and, pursuant to its obligations under Section 19(g)(1) of the Act, the Exchange will surveil for compliance with the continued listing requirements. If the Fund or the Shares are not in compliance with the applicable listing requirements, the Exchange will commence delisting procedures under Exchange Rule 14.12.

    24 For a list of the current members and affiliate members of ISG, see www.isgportal.com. The Exchange notes that not all components of the Disclosed Portfolio for the Fund may trade on markets that are members of ISG or with which the Exchange has in place a comprehensive surveillance sharing agreement.

    Availability of Information

    As noted above, the Fund will comply with the requirements for Managed Fund Shares related to Disclosed Portfolio, Net Asset Value, and the Intraday Indicative Value. Additionally, the intra-day, closing and settlement prices of exchange-traded portfolio assets, including common stock, preferred stock, warrants, rights, exchange-listed Equity Holdings, ETFs, options, and futures, will be readily available from the securities exchanges and futures exchanges trading such securities and futures, as the case may be, automated quotation systems, published or other public sources, or online information services such as Bloomberg or Reuters. Intraday price quotations on both listed and OTC swaps, TIPS, 20% OTC Instruments, and fixed income instruments are available from major broker-dealer firms and from third-parties, which may provide prices free with a time delay or in real-time for a paid fee. Trade price and other information relating to Municipal Securities is available through the MSRB. Price information for cash equivalents will be available from major market data vendors. The Disclosed Portfolio will be available on the issuer's website free of charge. The Fund's website includes a form of the prospectus for the Fund and additional information related to NAV and other applicable quantitative information. Information regarding market price and trading volume of the Shares will be continuously available throughout the day on brokers' computer screens and other electronic services. Quotation and last sale information on the Shares will be available through the Consolidated Tape Association. Information regarding the previous day's closing price and trading volume for the Shares will be published daily in the financial section of newspapers. Quotation and last sale information for listed options contracts cleared by the Options Clearing Corporation will be available via the Options Price Reporting Authority. Trading in the Shares may be halted for market conditions or for reasons that, in the view of the Exchange, make trading inadvisable. The Exchange deems the Shares to be equity securities, thus rendering trading in the Shares subject to the Exchange's existing rules governing the trading of equity securities. The Exchange has appropriate rules to facilitate trading in the shares during all trading sessions.

    Information Circular

    Prior to the commencement of trading, the Exchange will inform its members in an Information Circular of the special characteristics and risks associated with trading the Shares. Specifically, the Information Circular will discuss the following: (1) The procedures for purchases and redemptions of Shares in Creation Units (and that Shares are not individually redeemable); (2) BZX Rule 3.7, which imposes suitability obligations on Exchange members with respect to recommending transactions in the Shares to customers; (3) how information regarding the Intraday Indicative Value and the Disclosed Portfolio is disseminated; (4) the risks involved in trading the Shares during the Pre-Opening 25 and After Hours Trading Sessions 26 when an updated Intraday Indicative Value will not be calculated or publicly disseminated; (5) the requirement that members deliver a prospectus to investors purchasing newly issued Shares prior to or concurrently with the confirmation of a transaction; and (6) trading information.

    25 The Pre-Opening Session is from 8:00 a.m. to 9:30 a.m. Eastern Time.

    26 The After Hours Trading Session is from 4:00 p.m. to 5:00 p.m. Eastern Time.

    In addition, the Information Circular will advise members, prior to the commencement of trading, of the prospectus delivery requirements applicable to the Fund. Members purchasing Shares from the Fund for resale to investors will deliver a prospectus to such investors. The Information Circular will also discuss any exemptive, no-action and interpretive relief granted by the Commission from any rules under the Act.

    In addition, the Information Circular will reference that the Fund is subject to various fees and expenses described in the Registration Statement. The Information Circular will also disclose the trading hours of the Shares of the Fund and the applicable NAV calculation time for the Shares. The Information Circular will disclose that information about the Shares of the Fund will be publicly available on the Fund's website.

    2. Statutory Basis

    The Exchange believes that the proposal is consistent with Section 6(b) of the Act 27 in general and Section 6(b)(5) of the Act 28 in particular in that it is designed to prevent fraudulent and manipulative acts and practices, to promote just and equitable principles of trade, to foster cooperation and coordination with persons engaged in facilitating transactions in securities, to remove impediments to and perfect the mechanism of a free and open market and a national market system and, in general, to protect investors and the public interest.

    27 15 U.S.C. 78f.

    28 15 U.S.C. 78f(b)(5).

    The Exchange believes that the proposed rule change is designed to prevent fraudulent and manipulative acts and practices, to promote just and equitable principles of trade, to foster cooperation and coordination with persons engaged in facilitating transactions in securities, to remove impediments to and perfect the mechanism of a free and open market and a national market system and, in general, to protect investors and the public interest in that the Shares will meet each of the initial and continued listing criteria in BZX Rule 14.11(i) except that the Fund may not comply with Rules 14.11(i)(4)(C)(iv)(a),29 14.11(i)(4)(C)(iv)(b),30 and/or 14.11(i)(4)(C)(v).31 The Exchange believes that the liquidity in the Treasury futures,32 Eurodollar futures,33 and TIPS 34 markets mitigates the concerns that Rule 14.11(i)(4)(C)(iv)(b) is intended to address and that such liquidity would help prevent the Shares from being susceptible to manipulation. Further, the Exchange believes that for listed swaps, including credit default swaps, interest rate swaps, and Inflation Swaps, the price transparency and surveillance performed by the applicable swap execution facility would similarly act to mitigate the risk of manipulation of the Shares. The Exchange also believes that the size of the inflation swaps market,35 which would include all of the Inflation Swaps that the Fund intends to invest in, also mitigates manipulation concerns relating to both listed and OTC Inflation Swaps held by the Fund.36

    29See supra note 4.

    30See supra note 5.

    31See supra note 6.

    32 In 2017, there were approximately 744 million Treasury futures contracts traded.

    33 In 2017, there were approximately 367 million Eurodollar futures contracts traded.

    34 In 2017, there were approximately $17 billion worth of TIPS traded at primary dealers on a daily basis.

    35 For purposes of this discussion, the term “inflation swaps market” means any swap contract that references either a measure of inflation, an inflation index, or an instrument designed to transfer inflation risk from one party to another.

    36 According to publicly available numbers from LCH. Clearnet Limited, which clears both listed and OTC swaps, as of October 26, 2018, there had been approximately $637 billion in U.S. dollar-denominated inflation swaps traded year-to-date, which would include the Inflation Swaps that the Fund intends to invest in, cleared through their platform alone.

    As it relates to addressing the policy concerns that Rule 14.11(i)(4)(C)(v) is intended to address, which provides that the notional value of OTC derivatives shall not exceed 20% of the weight of the portfolio (including gross notional exposures), in an effort to minimize exposure to potentially illiquid and manipulable derivatives contracts, the Exchange notes that the inflation swap market,37 which would include all of the listed and OTC Inflation Swaps that the Fund intends to invest in, is large and liquid, which the Exchange believes further mitigates the concerns which Rule 14.11(i)(4)(C)(v) is intended to address. The Exchange also notes that the Fund will attempt to limit counterparty risk in non-cleared OTC swap contracts, OTC Inflation Swaps, and interest rate swaps, by entering into such contracts only with counterparties the Adviser believes are creditworthy and by limiting the Fund's exposure to each counterparty. The Adviser will monitor the creditworthiness of each counterparty and the Fund's exposure to each counterparty on an ongoing basis. Further, the Exchange notes that notional principal never changes hands in such swaps transactions, and it is a theoretical value used to base the exchanged payments. A more accurate representation of the swaps value in order to monitor total counterparty risk would be the mark-to market value of the swap since inception, which the Adviser generally expects to remain below 15% of the Fund's net assets.

    37See supra note 35.

    As it relates to the requirement in Rule 14.11(i)(4)(C)(iv)(a) that at least 90% of the weight of the listed derivatives portion of the portfolio be in listed derivatives for which the Exchange may obtain information via ISG or for which the principal market is a market with which the Exchange has a comprehensive surveillance sharing agreement, the Exchange believes that its surveillance procedures are adequate to properly monitor the trading of the Shares on the Exchange during all trading sessions and to deter and detect violations of Exchange rules and the applicable federal securities laws. Additionally, all of the listed instruments that would not meet this requirement would nevertheless have a primary market that is a swap execution facility that is registered with and under the regulatory oversight of the CFTC.38

    38 The Exchange represents that not all CFTC registered swap execution facilities are members or affiliates of members of the ISG.

    Trading of the Shares through the Exchange will be subject to the Exchange's surveillance procedures for derivative products, including Managed Fund Shares. All of the futures contracts, listed options, ETFs, and certain of the listed Inflation Swaps, listed credit default swaps, Equity Holdings, and listed interest rate swaps held by the Fund will trade on markets that are a member of ISG or affiliated with a member of ISG or with which the Exchange has in place a comprehensive surveillance sharing agreement. The Exchange, FINRA, on behalf of the Exchange, or both will communicate regarding trading in the Shares and the underlying futures contracts, listed options, ETFs, and certain of the listed Inflation Swaps, credit default swaps, Equity Holdings, and listed interest rate swaps held by the Fund with the ISG, other markets or entities who are members or affiliates of the ISG, or with which the Exchange has entered into a comprehensive surveillance sharing agreement.39 The Exchange, FINRA, on behalf of the Exchange, or both may obtain information regarding trading in the Shares and the underlying futures contracts, listed options, ETFs, and certain of the listed Inflation Swaps, credit default swaps, Equity Holdings, and listed interest rate swaps held by the Fund via the ISG from other markets or entities who are members or affiliates of the ISG or with which the Exchange has entered into a comprehensive surveillance sharing agreement.40 Additionally, the Exchange or FINRA, on behalf of the Exchange, may access, as needed, trade information for certain fixed income instruments reported to TRACE and municipal securities reported to the MSRB. FINRA also can access data obtained from the MSRB relating to municipal bond trading activity for surveillance purposes in connection with trading in the Shares. The Exchange has a policy prohibiting the distribution of material non-public information by its employees.

    39See supra note 23 [sic].

    40See supra note 23 [sic].

    The Exchange notes that the Fund will meet and be subject to all other requirements of the Generic Listing Rules and other applicable continued listing requirements for Managed Fund Shares under Rule 14.11(i), including those requirements regarding the Disclosed Portfolio and the requirement that the Disclosed Portfolio and the NAV will be made available to all market participants at the same time,41 Intraday Indicative Value,42 suspension of trading or removal,43 trading halts,44 disclosure,45 and firewalls.46 Further, at least 100,000 Shares will be outstanding upon the commencement of trading.47

    41See Rules 14.11(i)(4)(A)(ii) and 14.11(i)(4)(B)(ii).

    42See Rule 14.11(i)(4)(B)(i).

    43See Rule 14.11(i)(4)(B)(iii).

    44See Rule 14.11(i)(4)(B)(iv).

    45See Rule 14.11(i)(6).

    46See Rule 14.11(i)(7).

    47See Rule 14.11(i)(4)(A)(i).

    For the above reasons, the Exchange believes that the proposed rule change is consistent with the requirements of Section 6(b)(5) of the Act.

    B. Self-Regulatory Organization's Statement on Burden on Competition

    The Exchange does not believe that the proposed rule change will impose any burden on competition that is not necessary or appropriate in furtherance of the purpose of the Act. The Exchange notes that the proposed rule change, rather will facilitate the listing and trading of an additional actively-managed exchange-traded product that will enhance competition among both market participants and listing venues, to the benefit of investors and the marketplace.

    C. Self-Regulatory Organization's Statement on Comments on the Proposed Rule Change Received From Members, Participants, or Others

    The Exchange has neither solicited nor received written comments on the proposed rule change.

    III. Date of Effectiveness of the Proposed Rule Change and Timing for Commission Action

    Within 45 days of the date of publication of this notice in the Federal Register or within such longer period up to 90 days (i) as the Commission may designate if it finds such longer period to be appropriate and publishes its reasons for so finding or (ii) as to which the Exchange consents, the Commission will:

    (A) by order approve or disapprove the proposed rule change, or

    (B) institute proceedings to determine whether the proposed rule change should be disapproved.

    IV. Solicitation of Comments

    Interested persons are invited to submit written data, views, and arguments concerning the foregoing, including whether the proposed rule change is consistent with the Act. Comments may be submitted by any of the following methods:

    Electronic Comments

    • Use the Commission's internet comment form (http://www.sec.gov/rules/sro.shtml); or

    • Send an email to [email protected]. Please include File Number SR-CboeBZX-2018-077 on the subject line.

    Paper Comments

    • Send paper comments in triplicate to Secretary, Securities and Exchange Commission, 100 F Street NE, Washington, DC 20549-1090.

    All submissions should refer to File Number SR-CboeBZX-2018-077. This file number should be included on the subject line if email is used. To help the Commission process and review your comments more efficiently, please use only one method. The Commission will post all comments on the Commission's internet website (http://www.sec.gov/rules/sro.shtml). Copies of the submission, all subsequent amendments, all written statements with respect to the proposed rule change that are filed with the Commission, and all written communications relating to the proposed rule change between the Commission and any person, other than those that may be withheld from the public in accordance with the provisions of 5 U.S.C. 552, will be available for website viewing and printing in the Commission's Public Reference Room, 100 F Street NE, Washington, DC 20549, on official business days between the hours of 10:00 a.m. and 3:00 p.m. Copies of the filing also will be available for inspection and copying at the principal office of the Exchange. All comments received will be posted without change. Persons submitting comments are cautioned that we do not redact or edit personal identifying information from comment submissions. You should submit only information that you wish to make available publicly. All submissions should refer to File Number SR-CboeBZX-2018-077 and should be submitted on or before December 12, 2018.

    For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.48

    48 17 CFR 200.30-3(a)(12).

    Eduardo A. Aleman, Assistant Secretary.
    [FR Doc. 2018-25344 Filed 11-20-18; 8:45 am] BILLING CODE 8011-01-P
    SECURITIES AND EXCHANGE COMMISSION [Release No. 34-84603; File No. SR-NYSEAMER-2018-48] Self-Regulatory Organizations; NYSE American LLC; Notice of Filing and Immediate Effectiveness of Proposed Change To Modify the NYSE American Options Fee Schedule November 15, 2018.

    Pursuant to Section 19(b)(1) 1 of the Securities Exchange Act of 1934 (the “Act”) 2 and Rule 19b-4 thereunder,3 notice is hereby given that, on November 8, 2018, NYSE American LLC (the “Exchange” or “NYSE American”) filed with the Securities and Exchange Commission (the “Commission”) the proposed rule change as described in Items I, II, and III below, which Items have been prepared by the self-regulatory organization. The Commission is publishing this notice to solicit comments on the proposed rule change from interested persons.

    1 15 U.S.C.78s(b)(1).

    2 15 U.S.C. 78a.

    3 17 CFR 240.19b-4.

    I. Self-Regulatory Organization's Statement of the Terms of Substance of the Proposed Rule Change

    The Exchange proposes to modify the NYSE American Options Fee Schedule (“Fee Schedule”). The Exchange proposes to implement the fee change effective November 8, 2018. The proposed change is available on the Exchange's website at www.nyse.com, at the principal office of the Exchange, and at the Commission's Public Reference Room.

    II. Self-Regulatory Organization's Statement of the Purpose of, and Statutory Basis for, the Proposed Rule Change

    In its filing with the Commission, the self-regulatory organization included statements concerning the purpose of, and basis for, the proposed rule change and discussed any comments it received on the proposed rule change. The text of those statements may be examined at the places specified in Item IV below. The Exchange has prepared summaries, set forth in sections A, B, and C below, of the most significant parts of such statements.

    A. Self-Regulatory Organization's Statement of the Purpose of, and the Statutory Basis for, the Proposed Rule Change 1. Purpose

    The purpose of this filing is to modify the Fee Schedule, effective November 8, 2018, to eliminate obsolete charges. Specifically, the Exchange proposes to remove now obsolete references to fees for Mini Options and Binary Return Derivatives (“ByRDS”), and to modify its Royalty Fees to remove products that the Exchange is no longer licensed to trade.

    The Exchange adopted fees for Mini Options in 2013, when Mini Options were first listed.4 In the intervening years, the Exchange ceased adding new Mini-Option series, and eventually there were no Mini-Options trading on the Exchange. Thus, the Exchange proposes to remove from the Fee Schedule as obsolete all references to Mini-Options and associated fees.5 Given that the Exchange is removing Mini Options, it proposes to further streamline the Fee Schedule by removing as superfluous the designation of “Standard” as to delineate non-Mini Options and to make any related conforming changes to maintain appropriate grammar, sentence structure, etc.6

    4See, e.g., Securities Exchange Act Release No. 69298 (April 4, 2013), 78 FR 21464 (April 10, 2013) (NYSEMKT-2013-24).

    5See proposed Fee Schedule, Table of Contents, Key Terms and Definitions, Sections I.B., I.C., I.F., I.I., I.J., I.L., II and III. The Exchange proposes to hold Section I.B., which currently sets forth fees for Mini Options, as Reserved.

    6See proposed Fee Schedule, Table of Contents, Key Terms and Definitions, Sections I.A.-I.G., I.I-I.J., I.L., II and III.

    The Exchange listed ByRDs for trading in 2016,7 but ceased adding new series earlier this year, and no longer has any ByRDs available for trading. Thus, the Exchange proposes to remove from the Fee Schedule as obsolete all references to ByRDs and associated fees/credits as well as to make necessary conforming changes, including deleting note 5 to Section I.A. and re-numbering the balance of the notes to this section to maintain clarity and consistency.8

    7 The Exchange adopted ByRDs in 2007 and re-launched trading in ByRDs in March, 2016. See Securities Exchange Act Release No. 56251 (August 14, 2007), 72 FR 46523 (August 20, 2007)(SR-Amex-2004-27) (Order approving listing of Fixed Return Options (“FROs”)); see also Securities Exchange Act Release Nos. 71957 (April 16, 2014), 79 FR 22563 (April 22, 2014) (SR-NYSEMKT-2014-06) (Order approving name change from FROs to Binary Return Derivatives (ByRDs) and re-launch of these products, with certain modification, and amending Obvious Errors rules to include ByRDs); 77014 (February 2, 2016), 81 FR 6566 (February 8, 2016) (SR-NYSEMKT-2016-16) (immediate effectiveness filing amending amend certain of rules related to ByRDs).

    8See proposed Fee Schedule, Table of Contents, Sections I.A., I.H., I.M, and III.C., note 1. The Exchange proposes to hold Section I.H., which currently sets the Early Adopter Specialist [in ByRDs], as Reserved.

    Section I.K. of the Fee Schedule contains a table that sets forth the Royalty Fees that the Exchange charges market participant for trades in proprietary products for which the Exchange has a license, namely: Mini Nasdaq 100 Index (NDX), Nasdaq 100 Index (MNX), the Russell Index (RUT), and KBW Bank Index (BKX). The Exchange proposes to delete the table and to instead reference a $0.10 per contract Royalty Fee for BKX, as this product continues to be licensed to the Exchange.9

    9See proposed Fee Schedule, Section I.K.

    2. Statutory Basis

    The Exchange believes that the proposed rule change is consistent with Section 6(b) of the Act,10 in general, and furthers the objectives of Sections 6(b)(4) and (5) of the Act,11 in particular, because it provides for the equitable allocation of reasonable dues, fees, and other charges among its members, issuers and other persons using its facilities and does not unfairly discriminate between customers, issuers, brokers or dealers.

    10 15 U.S.C. 78f(b).

    11 15 U.S.C. 78f(b)(4) and (5).

    The Exchange believes that the proposed modifications to the Fee Schedule, including removing obsolete references to products that the Exchange no longer offers or licenses, together with their associated fees, are reasonable, equitable, and not unfairly discriminatory because the changes provides clarity to the Fee Schedule, and does not affect any current activity by any ATP Holder. Relatedly, the proposed modifications to streamline the text of the Fee Schedule, including by removing the modifier “Standard” to delineate on non-Mini Option, would likewise add clarity and transparency to the Fee Schedule making it easier for market participants to navigate and comprehend.

    B. Self-Regulatory Organization's Statement on Burden on Competition

    In accordance with Section 6(b)(8) of the Act,12 the Exchange does not believe that the proposed rule change would impose any burden on competition that is not necessary or appropriate in furtherance of the purposes of the Act. Instead, the proposed change is meant to add clarity and transparency to the Fee Schedule to the benefit of all market participants that trade on the Exchange.

    12 15 U.S.C. 78f(b)(8).

    C. Self-Regulatory Organization's Statement on Comments on the Proposed Rule Change Received From Members, Participants, or Others

    No written comments were solicited or received with respect to the proposed rule change.

    III. Date of Effectiveness of the Proposed Rule Change and Timing for Commission Action

    The foregoing rule change is effective upon filing pursuant to Section 19(b)(3)(A) 13 of the Act and subparagraph (f)(2) of Rule 19b-4 14 thereunder, because it establishes a due, fee, or other charge imposed by the Exchange.

    13 15 U.S.C. 78s(b)(3)(A).

    14 17 CFR 240.19b-4(f)(2).

    At any time within 60 days of the filing of such proposed rule change, the Commission summarily may temporarily suspend such rule change if it appears to the Commission that such action is necessary or appropriate in the public interest, for the protection of investors, or otherwise in furtherance of the purposes of the Act. If the Commission takes such action, the Commission shall institute proceedings under Section 19(b)(2)(B) 15 of the Act to determine whether the proposed rule change should be approved or disapproved.

    15 15 U.S.C. 78s(b)(2)(B).

    IV. Solicitation of Comments

    Interested persons are invited to submit written data, views, and arguments concerning the foregoing, including whether the proposed rule change is consistent with the Act. Comments may be submitted by any of the following methods:

    Electronic Comments

    • Use the Commission's internet comment form (http://www.sec.gov/rules/sro.shtml); or

    • Send an email to [email protected]. Please include File Number SR-NYSEAMER-2018-48 on the subject line.

    Paper Comments

    • Send paper comments in triplicate to Brent J. Fields, Secretary, Securities and Exchange Commission, 100 F Street NE, Washington, DC 20549-1090.

    All submissions should refer to File Number SR-NYSEAMER-2018-48. This file number should be included on the subject line if email is used. To help the Commission process and review your comments more efficiently, please use only one method. The Commission will post all comments on the Commission's internet website (http://www.sec.gov/rules/sro.shtml). Copies of the submission, all subsequent amendments, all written statements with respect to the proposed rule change that are filed with the Commission, and all written communications relating to the proposed rule change between the Commission and any person, other than those that may be withheld from the public in accordance with the provisions of 5 U.S.C. 552, will be available for website viewing and printing in the Commission's Public Reference Room, 100 F Street NE, Washington, DC 20549 on official business days between the hours of 10:00 a.m. and 3:00 p.m. Copies of the filing also will be available for inspection and copying at the principal office of the Exchange. All comments received will be posted without change. Persons submitting comments are cautioned that we do not redact or edit personal identifying information from comment submissions. You should submit only information that you wish to make available publicly. All submissions should refer to File Number SR-NYSEAMER-2018-48 and should be submitted on or before December 12, 2018.

    For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.16

    16 17 CFR 200.30-3(a)(12).

    Eduardo A. Aleman, Assistant Secretary.
    [FR Doc. 2018-25343 Filed 11-20-18; 8:45 am] BILLING CODE 8011-01-P
    SECURITIES AND EXCHANGE COMMISSION [Release No. 34-84599; File No. SR-CboeEDGA-2018-017] Self-Regulatory Organizations; Cboe EDGA Exchange, Inc.; Notice of Filing and Immediate Effectiveness of a Proposed Rule Change Relating To Amend the Exchange's Fee Schedule Applicable to its Equities Trading Platform November 15, 2018.

    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (the “Act”),1 and Rule 19b-4 thereunder,2 notice is hereby given that on November 1, 2018, EDGA Exchange, Inc. (the “Exchange” or “EDGA”) filed with the Securities and Exchange Commission (the “Commission”) the proposed rule change as described in Items I and II below, which Items have been prepared by the Exchange. The Commission is publishing this notice to solicit comments on the proposed rule change from interested persons.

    1 15 U.S.C. 78s(b)(1).

    2 17 CFR 240.19b-4.

    I. Self-Regulatory Organization's Statement of the Terms of Substance of the Proposed Rule Change

    Cboe EDGA Exchange, Inc. (“EDGA” or the “Exchange”) is filing with the Securities and Exchange Commission (the “Commission”) a proposed rule change to amend the Exchange's fee schedule applicable to its equities trading platform.

    The text of the proposed rule change is also available on the Exchange's website (http://www.cboe.com/AboutCBOE/CBOELegalRegulatoryHome.aspx), at the Exchange's Office of the Secretary, and at the Commission's Public Reference Room.

    II. Self-Regulatory Organization's Statement of the Purpose of, and Statutory Basis for, the Proposed Rule Change

    In its filing with the Commission, the Exchange included statements concerning the purpose of and basis for the proposed rule change and discussed any comments it received on the proposed rule change. The text of these statements may be examined at the places specified in Item IV below. The Exchange has prepared summaries, set forth in Sections A, B, and C below, of the most significant parts of such statements.

    A. Self-Regulatory Organization's Statement of the Purpose of, and the Statutory Basis for, the Proposed Rule Change 1. Purpose

    The Exchange proposes to amend its fee schedule, effective November 1, 2018, to (i) amend transaction fee rates, (ii) amend the definition for fee code MT, (iii) adopt new Add and Remove Volume Tiers, (iv) amend the threshold under the RMPT/RMPL Tier, and (v) adopt a new Routing Tier.

    Transaction Fee Changes Orders That Add Liquidity

    In securities priced at or above $1.00, the Exchange currently charges a fee of $0.00080 per share for Displayed and Non-Displayed orders that add liquidity. All Displayed and Non-Displayed orders in securities priced below $1.00 that add liquidity are free. The Exchange first proposes to increase this transaction fee and assess a standard rate of $0.0030 per share for Displayed and Non-Displayed orders that add liquidity for securities at or above $1.00 that are appended with fee codes B, V, Y, 3, 4, RP, HA, DA, and DM. The Exchange notes that it is not proposing to increase the fee for Non-Displayed orders that add liquidity using Mid-Point Peg, which orders yield fee code MM. All Displayed and Non-Displayed orders in securities priced below $1.00 that add liquidity would continue to be free.

    Orders That Remove Liquidity

    In securities priced at or above $1.00, the Exchange currently provides a rebate of $0.00040 per share for Displayed orders that remove liquidity (i.e., yields fee codes N, W, 6 and BB) and provides free executions for Non-Displayed orders that remove liquidity (i.e., yields fee codes DR, DT, HR, and MT). All Displayed and Non-Displayed orders in securities priced below $1.00 that remove liquidity are currently free, with the exception of orders that yield fee codes HR and MT, which result in a fee of 0.05% of dollar value.

    With respect to Displayed orders priced at or above $1.00 that remove liquidity, the Exchange proposes to increase the per share rebate from $0.00040 to $0.0024 (i.e., yields fee codes N, W, 6, or BB). All Displayed orders in securities priced below $1.00 would continue to be free.

    With respect to Non-Displayed orders priced at or above $1.00 that remove liquidity, the Exchange proposes to offer a $0.0024 per share rebate for Non-Displayed orders that remove liquidity using MidPoint Discretionary order not within discretionary range (i.e., yields fee code DR).

    With respect to the Non-Displayed orders priced below $1.00 that remove liquidity (i.e., yields fee code HR) and removes liquidity using MidPoint Peg (i.e., yields fee code MT 3 ), the Exchange proposes to eliminate the current fee of 0.05% of dollar value and make these executions free, which will result in all Non-Displayed orders in securities priced below $1.00 being treated the same (i.e., no fees or rebates assessed).

    3 The Exchange is proposing to amend the definition of orders that yield fee code MT, as further described in this rule filing.

    Fee Code MT

    The Exchange also proposes to modify the definition of fee code MT. Currently, fee code MT is appended to all Non-Displayed orders that remove liquidity using Mid Point Peg order type.4 The Exchange proposes to modify the types of orders that yield fee code MT, such that fee code MT will be appended to all orders that remove Mid-Point Peg Order liquidity (“Mid-Point Peg liquidity”) from EDGA, (i.e., any order for which a Mid-Point Peg order that adds liquidity (fee code MM) is the contra). The Exchange notes that the proposed amended definition for the MT fee code is the same as the definition (i.e., configuration) for the same fee code (MT) on its affiliate exchange, Cboe BYX Exchange, Inc.5

    4See Cboe EDGA Rule 11.8(d). Mid-Point Peg Orders are non-displayed Market Orders or Limit Orders with an instruction to execute at the midpoint of the NBBO, or, alternatively, pegged to the less aggressive of the midpoint of the NBBO or one minimum price variation inside the same side of the NBBO as the order.

    5See Cboe BYX Equities Exchange Fee Schedule, Fee Codes and Associated Fees, fee code MT.

    Add/Remove Volume Tiers

    The Exchange next proposes to adopt an Add Volume Tier, Tier 1 and Remove Volume Tier, Tier 1 (under new footnote 7). Particularly, proposed Add Volume Tier 1 would provide a reduced fee of $0.0026 per share for members that add an ADAV of greater than or equal to 0.10% of the TCV 6 for orders that add liquidity yielding fee codes 3, 4, B, v and Y. The Exchange proposes to also add language in its Definitions section defining “ADAV”. Specifically, ADAV shall mean average daily added volume calculated as the number of shares added per day.7 The Exchange notes that the proposed definition of ADAV is similar to definitions at other Exchanges, such as its affiliate Exchange, Cboe BYX Exchange, Inc. (“BYX”). Additionally, BYX has a similar Add Volume Tiers that require members to reach ADAV thresholds of the TCV.8 The Exchange believes the proposed change will encourage members to increase their liquidity on the Exchange.

    6 TCV means total consolidated volume calculated as the volume reported by all exchanges and trade reporting facilities to a consolidated transaction reporting plan for the month for which the fees apply. See Exchange's fee schedule.

    7 Like ADV (which means average daily volume calculated as the number of shares added to, removed from, or routed by, the Exchange (or any subset thereof), ADAV will be calculated on a monthly basis. Additionally, as with ADV, the Exchange will exclude from its calculation of ADAV shares added, removed, or routed on any day that the Exchange's system experiences a disruption that lasts for more than 60 minutes during Regular Trading Hours, on any day with a scheduled early market close, and on the last Friday in June. A member will be able to aggregate ADAV (and ADV) with other Members that control, are controlled by, or are under common control with such Member).

    8See Cboe BYX Exchange, Inc. Equities Exchange Fee Schedule, Footnote 1.

    The Exchange proposes to adopt Remove Volume Tier 1, which would provide an enhanced rebate of $0.0026 per share for members that (1) has an ADAV of greater than or equal to 0.20% of the TCV and (2) has a remove ADV 9 greater than or equal to 0.40% of the TCV for orders that remove liquidity yielding fee codes N, W, 6 and BB. The Exchange believes the proposed tier will encourage members to increase their liquidity on the Exchange. The Exchange also notes that other exchanges have similar volume tiers with similar requirements.10

    9 ADV means average daily volume calculated as the number of shares added to, removed from, or routed by, the Exchange, or any combination or subset thereof, per day. ADV is calculated on a monthly basis. See Exchange's fee schedule.

    10See Nasdaq BX, Inc. (“BX”) Rule 7018, Nasdaq BX Equities System Order Execution and Routing, which provides a credit for orders that meet thresholds relating to accessing liquidity and adding liquidity. See also Cboe BYX U.S. Equities Exchange Fee Schedule, Volume Tier 8 under Footnote 1.

    The Exchange believes the proposed volume requirements under both Add and Remove Volume Tiers 1 are commensurate with the level of the incentives provided.

    Amend RMPT/RMPL Tier

    The Exchange currently offers a tier under footnote 1, the RMPT/RMPL Tier under which a Member receives a discounted fee of $0.0008 per share for orders yielding fee code PX where that Member meets certain required criteria. Fee code PX is appended to orders that are routed using the RMPL routing strategy to a destination not covered by fee code PL, or are routed using the RMPT routing strategy, and are assessed a fee of $0.00120 per share on securities priced over $1.00, and a fee of 30% of the total dollar value on securities priced below $1.00. Under Tier 1, a Member is charged a discounted fee of $0.0008 per share for orders yielding fee code PX where they add or remove an ADV greater than or equal to 4,000,000 shares using the RMPT or RMPL 11 routing strategies (i.e., yielding fee codes PA, PL, PT and PX). The Exchange proposes amend the ADV requirement of Tier 1 from greater or equal to 4,000,000 shares to 2,000,000 shares.

    11See Cboe EDGA Rule 11.11(g)(13).

    Adopt ROUT Tier

    The Exchange proposes to also adopt a new routing tier for orders routed using the ROUT strategy 12 (“ROUT Tier”), under Footnote 1 of the Fees Schedule. Particularly, the Exchange proposes to offer a discounted fee of $0.0026 per share for orders yielding fee code RT where that Member meets certain required criteria. Fee code RT is appended to orders that are routed using the ROUT routing strategy, and are assessed a fee of $0.00280 per share on securities priced over $1.00, and a fee of 30% of the total dollar value on securities priced below $1.00. The Exchange proposes to provide that under ROUT Tier 1, a Member will be charged a discounted fee of $0.0026 per share for orders yielding fee code RT where the Member routes an ADV than or equal to 3,000,000 shares using routing strategy ROUT (i.e., yielding fee codes RT and RX).13 In connection the proposed changes, the Exchange proposes to also change the title of Footnote 1 from “RMPT/RMPL Tiers” to “Routing Tiers” to address both the RMPT/RMPL Tier and the new proposed ROUT Tier.

    12See Cboe EDGA Rule 11.11(g)(3).

    13 Pursuant to the Fees Schedule, variable rates provided by tiers apply only to executions in securities priced at or above $1.00.

    2. Statutory Basis

    The Exchange also believes the proposed rule change is consistent with Section 6(b)(4) of the Act, which requires that Exchange rules provide for the equitable allocation of reasonable dues, fees, and other charges among its members and other persons using its facilities.

    The Exchange believes its proposal to increase rates for Non-Displayed and Displayed orders that add liquidity (other than orders that yield fee code MM) is reasonable because the Exchange must balance the cost of rebates for orders that remove liquidity (and as described above, the Exchange is increasing the rebates provided for orders that remove liquidity). Additionally, the Exchange notes that the proposed fee is similar to, and in line with, transaction fees assessed on other Exchanges.14 Additionally the Exchange notes the proposed fee increase applies uniformly to members.

    14See e.g., NYSE Arca Equities, Fees and Charges, NYSE Arca Marketplace: Trade Related Fees and Credits.

    The Exchange believes the proposed increased rebate for Displayed orders that remove liquidity is reasonable, equitable and not unfairly discriminatory because it provides a higher rebate to members and is designed to further incentivize members to bring additional liquidity to the Exchange, thereby promoting price discovery and enhancing order execution opportunities for members. The Exchange believes the proposed changes are equitable and not unfairly discriminatory because they apply equally to all members. Furthermore, the Exchange's inverted fee structure would continue to incentivize liquidity takers since orders that remove liquidity would remain eligible for better pricing—including increased rebates for displayed orders and free executions for non-displayed orders—than orders that add liquidity and are charged a fee.

    The Exchange believes the proposal to adopt a rebate for orders that remove liquidity using MidPoint Discretionary Orders not within discretionary range (i.e., orders yielding fee code DR) is reasonable because it provides a rebate to members for these executions they were not otherwise receiving. Additionally, the Exchange notes the proposed rebate is the same as the rebate offered for Displayed orders that remove liquidity. The Exchange notes the proposed rule change applies uniformly to all members.

    The Exchange believes the proposal to provide free executions for orders priced below $1.00 and yielding fee codes HR and MT is reasonable, because members will no longer be assessed any fees for these particular transactions. The Exchange also notes the proposed change results in all Non-Displayed orders in securities priced below $1.00 being treated the same (i.e., no fees or rebates assessed). The proposed change also applies equally to all members.

    The Exchange believes the proposed change to the definition for fee code MT is reasonable because orders that currently yield fee code MT (i.e., Non-Displayed Mid-Point Peg orders that remove liquidity) will continue to receive free executions, as going forward they will be appended with either fee code HR (i.e., Non-displayed orders that remove liquidity), if contra to any order that adds liquidity other than Mid-Point Peg orders, or MT (i.e., an order that removes Mid-Point order liquidity), if contra to a Mid-Point Peg order that adds liquidity. Additionally, the proposed rule change is reasonable because all Displayed and Non-Displayed orders that remove a Non-Displayed Mid-Point Peg Order will also receive a free execution. The proposed rule change is equitable and not unfairly discriminatory because it applies to all members. Additionally, as noted above, the proposed definition of fee code MT is the same as the definition used on another exchange.15

    15See Cboe BYX Equities Exchange Fee Schedule, Fee Codes and Associated Fees, fee code MT.

    The Exchange believes the proposal to adopt an Add and Remove Volume Tier, along with a ROUT Tier, is reasonable because it provides members an opportunity to receive a reduced fee or enhanced rebate, depending on the Tier. The Exchange additionally notes that volume-based discounts have been widely adopted by exchanges and are equitable and non-discriminatory because they are open to all members on an equal basis and provide additional benefits or discounts that are reasonably related to (i) the value of an exchange's market quality; (ii) associated with higher levels of market activity, such as higher levels of liquidity provision and/or growth patterns; and (iii) introduction of higher volumes of orders into the price and volume discovery processes. The proposed required criteria of the Volume Tiers are intended to incentivize Members to send additional orders to the Exchange in an effort to qualify for the reduce fee and enhanced rebate made available by the respective tiers. The Exchange also notes that increased volume on the Exchange provides greater trading opportunities for all market participants. As noted previously, the Exchange also believes the proposed required criteria under the Add and Remove Volume Tiers 1 and ROUT Tier are commensurate with the level of the incentives provided.

    The Exchange believe that the amendment to the RMPL/RMPT Tier is reasonable and equitable because the amount of the discounted fee is not changing and because the amendment to the required criteria is designed to make it easier for market participants to satisfy the tier and thus receive a discounted rate. The Exchange also believes notwithstanding the proposed change, RMPL/RMPT Tier 1 still attracts additional midpoint liquidity to the Exchange, resulting in increased price improvement opportunities for orders seeking an execution at the midpoint of the NBBO on the Exchange or elsewhere. The Exchange notes that routing through the Exchange is voluntary. The Exchange also believes that the proposed routing tier change is non-discriminatory because it applies uniformly to all members.

    B. Self-Regulatory Organization's Statement on Burden on Competition

    The Exchange does not believe that the proposed rule change will result in any burden on competition that is not necessary or appropriate in furtherance of the purposes of the Act, as amended. Particularly, the proposed rates and rebates would apply uniformly to all members, and members may opt to disfavor the Exchange's pricing if they believe that alternatives offer them better value. Accordingly, the Exchange does not believe that the proposed changes will impair the ability of members or competing venues to maintain their competitive standing in the financial markets. Further, excessive fees would serve to impair an exchange's ability to compete for order flow and members rather than burdening competition. Moreover, the proposed fee changes are designed to incentivize liquidity, which the Exchange believes will benefit all market participants by encouraging a transparent and competitive market. The Exchange operates in a highly competitive market in which market participants can readily direct their order flow to competing venues. In such an environment, the Exchange must continually review, and consider adjusting, its fees and rebates to remain competitive with other exchanges. For the reasons described above, the Exchange believes that the proposed fee changes reflect this competitive environment.

    C. Self-Regulatory Organization's Statement on Comments on the Proposed Rule Change Received From Members, Participants, or Others

    No written comments were either solicited or received.

    III. Date of Effectiveness of the Proposed Rule Change and Timing for Commission Action

    The foregoing rule change has become effective pursuant to Section 19(b)(3)(A) of the Act 16 and paragraph (f) of Rule 19b-4 thereunder.17 At any time within 60 days of the filing of the proposed rule change, the Commission summarily may temporarily suspend such rule change if it appears to the Commission that such action is necessary or appropriate in the public interest, for the protection of investors, or otherwise in furtherance of the purposes of the Act.

    16 15 U.S.C. 78s(b)(3)(A).

    17 17 CFR 240.19b-4(f).

    IV. Solicitation of Comments

    Interested persons are invited to submit written data, views, and arguments concerning the foregoing, including whether the proposed rule change is consistent with the Act. Comments may be submitted by any of the following methods:

    Electronic Comments

    • Use the Commission's internet comment form (http://www.sec.gov/rules/sro.shtml); or

    • Send an email to [email protected]. Please include File Number SR-CboeEDGA-2018-017 on the subject line.

    Paper Comments

    • Send paper comments in triplicate to Secretary, Securities and Exchange Commission, 100 F Street NE, Washington, DC 20549-1090.

    All submissions should refer to File Number SR-CboeEDGA-2018-017. This file number should be included on the subject line if email is used. To help the Commission process and review your comments more efficiently, please use only one method. The Commission will post all comments on the Commission's internet website (http://www.sec.gov/rules/sro.shtml). Copies of the submission, all subsequent amendments, all written statements with respect to the proposed rule change that are filed with the Commission, and all written communications relating to the proposed rule change between the Commission and any person, other than those that may be withheld from the public in accordance with the provisions of 5 U.S.C. 552, will be available for website viewing and printing in the Commission's Public Reference Room, 100 F Street NE, Washington, DC 20549, on official business days between the hours of 10:00 a.m. and 3:00 p.m. Copies of this filing will also be available for inspection and copying at the principal office of the Exchange. All comments received will be posted without change. Persons submitting comments are cautioned that we do not redact or edit personal identifying information from comment submissions. You should submit only information that you wish to make available publicly. All submissions should refer to File Number SR-CboeEDGA-2018-017 and should be submitted on or before December 12, 2018.

    For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.18

    18 17 CFR 200.30-3(a)(12).

    Eduardo A. Aleman, Assistant Secretary.
    [FR Doc. 2018-25340 Filed 11-20-18; 8:45 am] BILLING CODE 8011-01-P
    SECURITIES AND EXCHANGE COMMISSION [Release No. 34-84602; File No. SR-LCH SA-2018-005] Self-Regulatory Organizations; LCH SA; Notice of Filing and Immediate Effectiveness of Proposed Rule Change, as Modified by Amendment No. 1, Relating to a New Fee Incentive Scheme November 15, 2018.

    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (“Act”),1 and Rule 19b-4 thereunder,2 notice is hereby given that on October 31, 2018, Banque Centrale de Compensation, which conducts business under the name LCH SA (“LCH SA”), filed with the Securities and Exchange Commission (“Commission”) the proposed rule change described in Items I, II and III below, which Items have been prepared by LCH SA. On November 15, 2018, LCH SA filed Amendment No. 1 to the proposed rule change.3 LCH SA filed the proposal pursuant to Section 19(b)(3)(A) of the Act,4 and Rule 19b-4(f)(2) 5 thereunder, so that the proposal was effective upon filing with the Commission. The Commission is publishing this notice to solicit comments on the proposed rule change, as modified by Amendment No. 1, from interested persons.

    1 15 U.S.C. 78s(b)(1).

    2 17 CFR 240.19b-4.

    3 In Amendment No. 1, LCH SA added to Item II an additional description of the proposed fees.

    4 15 U.S.C. 78s(b)(3)(A).

    5 17 CFR 240.19b-4(f)(2).

    I. Clearing Agency's Statement of the Terms of Substance of the Proposed Rule Change

    The proposed rule change will introduce a new fee incentive scheme for CDSClear client clearing activities applicable from October 31st, 2018.

    II. Clearing Agency's Statement of the Purpose of, and Statutory Basis for, the Proposed Rule Change

    In its filing with the Commission, LCH SA included statements concerning the purpose of and basis for the proposed rule change and discussed any comments it received on the proposed rule change. The text of these statements may be examined at the places specified in Item IV below. LCH SA has prepared summaries, set forth in sections A, B, and C below, of the most significant aspects of such statements.

    A. Clearing Agency's Statement of the Purpose of, and Statutory Basis for, the Proposed Rule Change 1. Purpose

    The purpose of the proposed rule change is for LCH SA to introduce and specify a clearing fees incentive scheme for clients of CDSClear members, including volume based discounts, in order to encourage the growth of the CDSClear client clearing franchise.

    Currently, CDSClear clearing members are charged a fee on their client clearing flows per EUR/USD million of gross notional cleared defined as follows:

    Variable Fee Client Clearing
  • (Per million gross notional cleared)
  • EUR
  • indices
  • EUR single names Credit index options—
  • EUR indices
  • US
  • indices
  • US single names Credit index option—
  • US indices *
  • €4 €12 €20 $5 $17 [$20] * Subject to regulatory approval.

    The proposed incentive scheme defines a fee rebate based on volumes in order to make it more attractive for new buy side clients to select CDSClear services and/or CDSClear existing clients to clear more by reducing the marginal cost of clearing past pre-defined volumes thresholds as detailed hereinafter and below in Exhibit 5.

    1. Quarterly Credit Index Option Thresholds Notional cleared (quarterly) Fees From €0 to €2bn Full published variable fees apply. From over €2bn to €10bn 20% discount on published variable fees (applicable only above 2bn). Over €10bn No further fees apply. 2. Quarterly Credit Index Thresholds Notional cleared (quarterly) Fees From €0 to €30bn Full published variable fees apply. Over €30bn No further fees apply. 3. Quarterly Corporate Single Name Thresholds Notional cleared (quarterly) Fees From €0 to €4bn Full published fees variable apply. Over €4bn No further fees apply.

    The thresholds apply to quarterly notional cleared and the potential resulting rebate will be applied on the bill for the last month of the quarter.

    The first quarterly notionals to be reviewed will be the Q4 2018 ones.

    The proposed fee discount scheme will be effective until 31st December 2020.

    Finally, the proposed incentive scheme will also exempt from clearing fees the registration of clients' positions at CDSClear resulting from the transfer of such positions from another CCP.

    2. Statutory Basis

    Section 17A(b)(3)(D) of the Act requires that the rules of a clearing agency provide for the equitable allocation of reasonable dues, fees, and other charges.6

    6 15 U.S.C. 78q-1(b)(3)(D).

    LCH SA has determined that the proposed fees are reasonable and appropriate to charge to offer and maintain CDSClear client clearing services.

    In particular, LCH SA believes that the volume-based discounts for CDSClear client clearing activities have been set up at an appropriate level given the costs and expenses to LCH SA in providing such services.

    LCH SA believes that imposing such clearing fees is consistent with the requirements of Section 17A of the Act 7 and the regulations thereunder applicable to it and in particular provides for the equitable allocation of reasonable fees, dues, and other charges among clearing members and market participants by ensuring that Members pay reasonable fees and dues for the services provided by LCH SA, within the meaning of Section 17A(b)(3)(D) of the Act.

    7 15 U.S.C. 78q-1.

    B. Clearing Agency's Statement on Burden on Competition

    Section 17A(b)(3)(I) of the Act requires that the rules of a clearing agency not impose any burden on competition not necessary or appropriate in furtherance of the purposes of the Act.8 LCH SA does not believe that the proposed rule change would impose any burden on competition.

    8 15 U.S.C. 78q-1(b)(3)(I).

    As noted above, LCH SA believes that the fees and related discounts have been set up at an appropriate level given the costs and expenses to LCH SA in offering and maintaining the relevant client clearing services.

    Additionally, the fees and related discounts will apply equally to all clients of all clearing members of CDSClear.

    Further, LCH SA does not believe that the proposed rule change would have a burden on competition because it does not adversely affect the ability of such Clearing Members or other market participants generally to engage in cleared transactions or to access clearing services.

    C. Clearing Agency's Statement on Comments on the Proposed Rule Change Received From Members, Participants or Others

    Written comments relating to the proposed rule change have not been solicited or received. LCH SA will notify the Commission of any written comments received by LCH SA.

    III. Date of Effectiveness of the Proposed Rule Change and Timing for Commission Action

    The foregoing proposed rule change has become effective upon filing pursuant to Section 19(b)(3)(A) 9 of the Act and Rule 19b-4(f)(2) 10 thereunder because it establishes a fee or other charge imposed by LCH SA on its Clearing Members. At any time within 60 days of the filing of the proposed rule change, the Commission summarily may temporarily suspend such proposed rule change if it appears to the Commission that such action is necessary or appropriate in the public interest, for the protection of investors, or otherwise in furtherance of the purposes of the Act.

    9 15 U.S.C. 78s(b)(3)(A).

    10 17 CFR 240.19b-4(f)(2).

    IV. Solicitation of Comments

    Interested persons are invited to submit written data, views, and arguments concerning the foregoing, including whether the proposed rule change, as modified by Amendment No. 1, is consistent with the Act. Comments may be submitted by any of the following methods:

    Electronic Comments

    • Use the Commission's internet comment form (http://www.sec.gov/rules/sro.shtml) or

    • Send an email to [email protected]. Please include File Number SR-LCH SA-2018-005 on the subject line.

    Paper Comments

    • Send paper comments in triplicate to Secretary, Securities and Exchange Commission, 100 F Street NE, Washington, DC 20549-1090.

    All submissions should refer to File Number SR-LCH SA-2018-005. This file number should be included on the subject line if email is used. To help the Commission process and review your comments more efficiently, please use only one method. The Commission will post all comments on the Commission's internet website (http://www.sec.gov/rules/sro.shtml). Copies of the submission, all subsequent amendments, all written statements with respect to the proposed rule change that are filed with the Commission, and all written communications relating to the proposed rule change between the Commission and any person, other than those that may be withheld from the public in accordance with the provisions of 5 U.S.C. 552, will be available for website viewing and printing in the Commission's Public Reference Room, 100 F Street NE, Washington, DC 20549, on official business days between the hours of 10:00 a.m. and 3:00 p.m. Copies of such filings will also be available for inspection and copying at the principal office of LCH SA and on LCH SA's website at https://www.lch.com/resources/rules-and-regulations/proposed-rule-changes-0.

    All comments received will be posted without change. Persons submitting comments are cautioned that we do not redact or edit personal identifying information from comment submissions. You should submit only information that you wish to make available publicly. All submissions should refer to File Number SR-LCH SA-2018-005 and should be submitted on or before December 12, 2018.

    For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.11

    11 17 CFR 200.30-3(a)(12).

    Eduardo A. Aleman, Assistant Secretary.
    [FR Doc. 2018-25342 Filed 11-20-18; 8:45 am] BILLING CODE 8011-01-P
    SECURITIES AND EXCHANGE COMMISSION [Release No. 34-84601; File No. SR-CFE-2018-001] Self-Regulatory Organizations; Cboe Futures Exchange, LLC; Notice of Filing of a Proposed Rule Change Regarding Minor Rule Violations November 15, 2018.

    Pursuant to Section 19(b)(7) of the Securities Exchange Act of 1934 (“Act”),1 notice is hereby given that on October 31, 2018 Cboe Futures Exchange, LLC (“CFE” or “Exchange”) filed with the Securities and Exchange Commission (“SEC” or “Commission”) the proposed rule change described in Items I, II, and III below, which Items have been prepared by CFE. The Commission is publishing this notice to solicit comments on the proposed rule change from interested persons. CFE also has filed this proposed rule change with the Commodity Futures Trading Commission (“CFTC”). CFE filed a written certification with the CFTC under Section 5c(c) of the Commodity Exchange Act (“CEA”) 2 on October 31, 2018.

    1 15 U.S.C. 78s(b)(7).

    2 7 U.S.C. 7a-2(c).

    I. Self-Regulatory Organization's Description of the Proposed Rule Change

    The Exchange proposes to amend its rules regarding the processing of minor rule violations. The scope of this filing is limited solely to the application of the proposed rule amendments to security futures that may be traded on CFE. Although no security futures are currently listed for trading on CFE, CFE may list security futures for trading in the future. The text of the proposed rule change is attached as Exhibit 4 to the filing but is not attached to the publication of this notice.

    II. Self-Regulatory Organization's Statement of the Purpose of, and Statutory Basis for, the Proposed Rule Change

    In its filing with the Commission, CFE included statements concerning the purpose of and basis for the proposed rule change and discussed any comments it received on the proposed rule change. The text of these statements may be examined at the places specified in Item IV below. CFE has prepared summaries, set forth in Sections A, B, and C below, of the most significant aspects of such statements.

    A. Self-Regulatory Organization's Statement of the Purpose of, and Statutory Basis for, the Proposed Rule Change 1. Purpose

    CFE Rule 714 (Imposition of Fines for Minor Rule Violations) provides for the issuance of letters of caution or summary fines for specified types of minor CFE rule violations instead of addressing these violations through formal disciplinary proceedings. Each violation type under Rule 714 has a summary fine schedule that includes increasing monetary fines for subsequent violations by a party during a specified rolling time period and a referral of that party to the CFE Business Conduct Committee once that party has committed a certain number of violations within that rolling time period. The referral to the BCC is so that a panel of the BCC (“BCC Panel”) may determine whether or not to authorize the issuance of a statement of charges against the party and proceed with a formal disciplinary proceeding with regard to the matter.

    CFE is making amendments to Rule 714 in conjunction with other rule amendments being made by CFE to its disciplinary rules, including to Rule 714, that are not required to be submitted to the Commission pursuant to Section 19(b)(7) of the Act 3 and thus are not included as part of this rule change. One of these other rule amendments is to vest in CFE's Chief Regulatory Officer (“CRO”) instead of in a BCC Panel the authority to determine whether to issue a statement charges in a CFE disciplinary matter.

    3 15 U.S.C. 78s(b)(7).

    Since BCC Panels will no longer be determining whether to issue statements of charges, the proposed rule change deletes referral to the BCC from each of the summary fine schedules under Rule 714 that addresses violations of CFE rule provisions related to recordkeeping and reporting requirements. These summary fine schedules include the summary fine schedules under the following subparagraphs of Rule 714(f) which have the following titles and relate back to the following CFE rule provisions referenced in those titles:

    (i) Rule 714(f)(i) relating to Failure to Include an Order Entry Operator ID with Order that is Submitted to the CFE System (CFE Rule 303A(a)), Improper Use of Order Entry Operator IDs (Rules 303A(b) and 303A(c)), and Failure to Comply with Issuance, Recordkeeping, and Reporting Requirements Related to Order Entry Operator IDs (Rule 303A(d));

    (ii) Rule 714(f)(ii) relating to Failure to Identify Correct Customer Type Indicator Code in Order (CFE Rule 403(a)(x));

    (iii) Rule 714(f)(iii) relating to Failure to Provide Correct Account Designation in Order (Rule 403(a)(xii));

    (iv) Rule 714(f)(iv) relating to Failure to Comply with Order Form Preparation and Recordkeeping Requirements Relating to Orders Which Cannot Be Immediately Entered into the CFE System (Rule 403(b)) and Failure to Maintain Front-End Audit Trail Information for All Electronic Orders Entered into the CFE System, Including Order Modifications and Cancellations (Rule 403(c));

    (v) Rule 714(f)(vi) relating to Failure to Comply with Notice Provisions for Position Accountability (CFE Rules 412A(c) and 412A(d));

    (vi) Rule 714(f)(vii) relating to Failure to Comply with Reporting Requirements for Ownership and Control Reports and Reportable Positions (CFE Rules 412B(a), 412B(b), and 412B(c));

    (vii) Rule 714(f)(viii) relating to Failure to Comply with Order Marking Requirement for Exchange of Contract for Related Position Transactions (CFE Rule 414(g)) and Failure to Comply with Recordkeeping Requirement for Exchange of Contract for Related Position Transactions (Rule 414(h));

    (viii) Rule 714(f)(ix) relating to Failure to Comply with Exchange of Contract for Related Position Transaction Rule Provisions Relating to Authorized Reporter (Rule 414(i));

    (ix) Rule 714(f)(x) relating to Failure to Comply with Exchange of Contract for Related Position Transaction Reporting Requirements (Rules 414(k) and 414(l));

    (x) Rule 714(f)(xi) relating to Failure to Comply with Order Marking Requirement for Block Trades (CFE Rule 415(a)(i)(A)) and Failure to Comply with Recordkeeping Requirements for Block Trades (Rule 415(e));

    (xi) Rule 714(f)(xiii) relating to Failure to Comply with Block Trade Rule Provisions Relating to Authorized Reporter (Rule 415(f));

    (xii) Rule 714(f)(xiv) relating to Failure to Comply with Block Trade Reporting Requirements (Rules 415(h) and 415(i)); and

    (xiii) Rule 714(f)(xv) relating to Failure to Provide Books and Records Within Designated Time Frame (CFE Rule 502 and Other CFE Rules Allowing CFE to Request Books and Records).

    Regulatory staff already has the ability to proceed with a formal disciplinary proceeding whenever regulatory staff determines that any violation covered by Rule 714 is intentional, egregious, or otherwise not minor in nature. The proposed rule change also amends Rule 714(f) to clarify that regulatory staff may also proceed with a formal disciplinary proceeding if the number of recurring violations of a particular type covered by Rule 714 within the rolling time period for that type of violation warrants a formal disciplinary proceeding. Accordingly, with the proposed rule change, there will not be a need for a referral after a certain number of violations within the applicable rolling time period since regulatory staff may initiate a formal disciplinary proceeding for any violation covered by Rule 714 when circumstances warrant no matter the number of previous violations of that type.

    2. Statutory Basis

    The Exchange believes that the proposed rule change is consistent with Section 6(b) of the Act,4 in general, and furthers the objectives of Sections 6(b)(5),5 6(b)(6),6 and 6(b)(7) 7 in particular in that it is designed:

    4 15 U.S.C. 78f(b).

    5 15 U.S.C. 78f(b)(5).

    6 15 U.S.C. 78f(b)(6).

    7 15 U.S.C. 78f(b)(7).

    • To prevent fraudulent and manipulative acts and practices;

    • to remove impediments to and perfect the mechanism of a free and open market and a national market system, and in general, to protect investors and the public interest;

    • to have rules that provide that Exchange members and persons associated with Exchange members shall be appropriately disciplined for violation of the Act, the rules and regulations thereunder, or the rules of the Exchange, by expulsion, suspension, limitation of activities, functions, and operations, fine, censure, being suspended or barred from being associated with a member, or any other fitting sanction; and

    • to provide a fair procedure for the disciplining of members and persons associated with members.

    The proposed rule change is consistent with these provisions in that CFE believes that the proposed rule change provides an effective and efficient means of disciplining parties for certain types of minor rule violations that do not warrant formal disciplinary proceedings while also permitting regulatory staff to initiate formal disciplinary proceedings for these types violations when circumstances warrant.

    B. Self-Regulatory Organization's Statement on Burden on Competition

    CFE does not believe that the proposed rule change will impose any burden on competition not necessary or appropriate in furtherance of the purposes of the Act in that the proposed rule change will improve the efficiency and functioning of CFE's disciplinary process by providing greater flexibility to regulatory staff to determine when to initiate a formal disciplinary proceeding for any violation covered by Rule 714. Additionally, CFE believes that the proposed amendments are equitable and not unfairly discriminatory because the changes will apply equally to all market participants.

    C. Self-Regulatory Organization's Statement on Comments on the Proposed Rule Change Received From Members, Participants, or Others

    No written comments were solicited or received with respect to the proposed rule change.

    III. Date of Effectiveness of the Proposed Rule Change and Timing for Commission Action

    The proposed rule change will become operative on November 15, 2018. At any time within 60 days of the date of effectiveness of the proposed rule change, the Commission, after consultation with the CFTC, may summarily abrogate the proposed rule change and require that the proposed rule change be refiled in accordance with the provisions of Section 19(b)(1) of the Act.8

    8 15 U.S.C. 78s(b)(1).

    IV. Solicitation of Comments

    Interested persons are invited to submit written data, views, and arguments concerning the foregoing, including whether the proposed rule change is consistent with the Act. Comments may be submitted by any of the following methods:

    Electronic Comments

    • Use the Commission's internet comment form (http://www.sec.gov/rules/sro.shtml); or

    • Send an email to [email protected]. Please include File Number SR-CFE-2018-001 on the subject line.

    Paper Comments

    • Send paper comments in triplicate to Secretary, Securities and Exchange Commission, 100 F Street NE, Washington, DC 20549-1090.

    All submissions should refer to File Number SR-CFE-2018-001. This file number should be included on the subject line if email is used. To help the Commission process and review your comments more efficiently, please use only one method. The Commission will post all comments on the Commission's internet website (http://www.sec.gov/rules/sro.shtml). Copies of the submission, all subsequent amendments, all written statements with respect to the proposed rule change that are filed with the Commission, and all written communications relating to the proposed rule change between the Commission and any person, other than those that may be withheld from the public in accordance with the provisions of 5 U.S.C. 552, will be available for website viewing and printing in the Commission's Public Reference Room, 100 F Street NE, Washington, DC 20549, on official business days between the hours of 10:00 a.m. and 3:00 p.m. Copies of such filing also will be available for inspection and copying at the principal office of the Exchange. All comments received will be posted without change. Persons submitting comments are cautioned that we do not redact or edit personal identifying information from comment submissions. You should submit only information that you wish to make available publicly. All submissions should refer to File Number SR-CFE-2018-001, and should be submitted on or before December 12, 2018.

    9 17 CFR 200.30-3(a)(73).

    For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.9

    Eduardo A. Aleman, Assistant Secretary.
    [FR Doc. 2018-25358 Filed 11-20-18; 8:45 am] BILLING CODE 8011-01-P
    SECURITIES AND EXCHANGE COMMISSION [Release No. 34-84600; File No. SR-CboeBYX-2018-014] Self-Regulatory Organizations; Cboe BYX Exchange, Inc.; Order Instituting Proceedings To Determine Whether To Approve or Disapprove a Proposed Rule Change To Make Permanent Exchange Rule 11.24, Which Sets Forth the Exchange's Pilot Retail Price Improvement Program November 15, 2018. I. Introduction

    On July 30, 2018, Cboe BYX Exchange, Inc. (“BYX” or the “Exchange”) filed with the Securities and Exchange Commission (the “Commission”), pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (“Act”) 1 and Rule 19b-4 thereunder,2 a proposed rule change to make permanent Exchange Rule 11.24, which sets forth the Exchange's pilot Retail Price Improvement Program. The proposed rule change was published for comment in the Federal Register on August 17, 2018.3 On September 27, 2018, the Commission extended to November 15, 2018, the time period in which to approve, disapprove, or institute proceedings to determine whether to approve or disapprove, the proposed rule change.4 The Commission received no comments on the proposed rule change. This order institutes proceedings under Section 19(b)(2)(B) of the Act 5 to determine whether to approve or disapprove the proposed rule change.

    1 15 U.S.C. 78s(b)(1).

    2 17 CFR 240.19b-4.

    3See Securities Exchange Act Release No. 83831 (August 13, 2018), 83 FR 41128 (“Notice”).

    4See Securities Exchange Act Release No. 84297, 83 FR 49959 (October 3, 2018).

    5 15 U.S.C. 78(s)(b)(2)(B).

    II. Summary of the Proposed Rule Change

    The Exchange proposes to amend Exchange Rule 11.24 to make permanent the Retail Price Improvement Program (the “Program”), which sets forth the rules and procedures governing the program and is currently offered on a pilot basis.6 The pilot is scheduled to expire upon the earlier of the approval of this proposed rule change or December 31, 2018.7 According to the Exchange, the Program is designed to attract retail order flow and allow such order flow to receive potential price improvement.8

    6 In November 2012, the Commission approved the Program on a pilot basis. See Securities Exchange Act Release No. 68303 (November 27, 2012), 77 FR 71652 (December 3, 2012) (“RPI Approval Order”) (SR-BYX-2012-019).

    7 The Exchange implemented the Program on January 11, 2013, and has extended the pilot period five times. See Securities Exchange Act Release Nos. 71249 (January 7, 2014), 79 FR 2229 (January 13, 2014) (SR-BYX-2014-001); 74111 (January 22, 2015), 80 FR 4598 (January 28, 2015) (SR-BYX-2015-05); 76965 (January 22, 2016), 81 FR 4682 (January 27, 2016) (SR-BYX-2016-01); 78180 (June 28, 2016), 81 FR 43306 (July 1, 2016) (SR-BYX-2016-15); and 81368 (August 10, 2017), 82 FR 38960 (August 16, 2017) (SR-BYX-2017-18).

    8See Notice, supra note 3 at 41128.

    Under the Program, a class of market participant called a Retail Member Organization (“RMO”) is eligible to submit certain retail order flow (“Retail Orders”) to the Exchange. A User 9 is permitted to provide potential price improvement for Retail Orders 10 by submitting Retail Price Improvement (“RPI”) Orders, which are non-displayed orders that are priced at least $0.001 better than the best protected bid (“PBB”) or best protected offer (“PBO”) (“PBBO”), as such terms are defined in Regulation NMS, and that is identified as such.11 After an RPI Order is submitted, the Exchange disseminates an indicator through its proprietary data feeds or through the Consolidated Tape Association/Consolidated Quotation Plan for Tape A and Tape B securities and the Nasdaq UTP Plan for Tape C securities, known as the Retail Liquidity Identifier, indicating that such interest exists.12 The Retail Liquidity Identifier reflects the symbol for the particular security and the side (buy or sell) of the RPI interest, but does not include the price or size of the RPI interest.13

    9 A “User” is defined in Exchange Rule 1.5(cc) as any member or sponsored participant of the Exchange who is authorized to obtain access to the System.

    10 A “Retail Order” is defined in Exchange Rule 11.24(a)(2) as an agency order or riskless principal that meets the criteria of FINRA Rule 53250.03 that originates from a natural person and is submitted to the Exchange by a RMO, provided that no change is made to the terms of the order with respect to price or side of market and the order does not originate from a trading algorithm or any computerized methodology. See Exchange Rule 11.24(a)(2).

    11See Notice, supra note 3 at 41128. As more fully set forth in the Notice, RPI Orders may be submitted with an explicit limit price, or an offset. RPI Orders submitted with an offset are similar to other peg orders in that the order is tied or “pegged” to a certain price, and would have its price automatically set and adjusted upon changes to the Protected NBBO. The offset is a predetermined amount by which the User is willing to improve the Protected NBBO, subject to a ceiling or floor price. The ceiling or floor price is the amount above or below which the User does not wish to trade. RPI Orders in their entirety (the buy or sell interest, the offset, and the ceiling or floor) will remain non-displayed.

    12See Notice, supra note 3 at 41130.

    13See id.

    To qualify as an RMO, a member organization must conduct a retail business or route retail orders on behalf of another broker-dealer.14 A member organization must submit the following to the Exchange for approval: (i) An application form, (ii) supporting documentation, and (iii) an attestation that substantially all orders submitted as retail orders will qualify as such. The Program provides for an appeal process for a disapproved applicant, and a withdraw process for RMOs. RMOs must have written policies and procedures reasonably designed to assure that they will only designate orders as Retail Orders if all requirements of a Retail Order are met. RMOs could be disqualified if they submit Retail Orders that do not meet the requirements of Retail Orders. If disqualified, RMOs may appeal and reapply.

    14See id.

    Under the Program, there are two types of Retail Orders. A Type 1 Retail Order will interact with only available contra-side RPI Orders and other price improving contra-side interest.15 A Type 1 Retail Order will not interact with other available contra-side interest or route to away markets. The unexecuted portion of a Type 1 Retail Order will be immediately cancelled. A Type 2 Retail Order will interact first with available contra-side RPI Orders and price-improving liquidity, and then any remaining portion will be executed as an immediate-or-cancel order.16 A Type 2-desiganted Retail Order can either be submitted as a BYX Only Order or an order eligible for routing.17

    15See id.

    16See id. at 41130-31.

    17See id. at 41131.

    The Program provides that RPI Orders will be ranked and allocated according to price-time priority. Executions occur in price time priority. Any remaining unexecuted RPI interest remains available to interact with other incoming Retail Orders if such interest is at an eligible price.

    A more detailed description of how the program operates, including but not limited to how a member organization may qualify an apply to become a RMO; the different types of Retail Orders; and priority and order allocation of RPI Orders is more fully set forth in the Notice.18

    18See Notice, supra note 3.

    As part of the RPI Approval Order, the Exchange agreed to provide the Commission with a significant amount of data to assist the Commission's evaluation of the Program.19 Specifically, the Exchange represented that it would “produce data throughout the pilot, which will include statistics about participation, the frequency and level of price improvement provided by the Program, and any effects on the broader market structure.” 20 The Commission expected the Exchange to monitor the scope and operation of the Program and study the data produced during that time with respect to such issues.21

    19See RPI Order, supra note 7, at 71657.

    20Id.

    21Id.

    In the Notice, the Exchange states that it believes that it has achieved its goal of attracting retail order flow to the Exchange.22 The Exchange further states that its analysis of the data collected demonstrates that “there has been consistent retail investor interest in the Program, which has provided tangible price improvement to those retail investors through a competitive pricing process over the course of the pilot.” 23 The Exchange also concluded that the data shows that the Program “had an overall negligible impact on broader market quality outside of the Program.” 24

    22See Notice, supra note 3, at 41131.

    23Id.

    24Id.

    III. Proceedings To Determine Whether To Approve or Disapprove the Proposed Rule Change and Grounds for Disapproval Under Consideration

    The Commission is instituting proceedings pursuant to Section 19(b)(2)(B) of the Act 25 to determine whether the proposal should be approved or disapproved. Institution of proceedings is appropriate at this time in view of the legal and policy issues raised by the proposal. Institution of disapproval proceedings does not indicate that the Commission has reached any conclusions with respect to any of the issues involved. Rather, as described in greater detail below, the Commission seeks and encourages interested persons to provide additional comment on the proposal.

    25 15 U.S.C. 78s(b)(2)(B).

    Pursuant to Section 19(b)(2)(B) of the Act,26 the Commission is providing notice of the grounds for disapproval under consideration. The Commission is instituting proceedings to allow for additional analysis of the proposed rule change's consistency with Section 6(b)(5) of the Act,27 which requires that the rules of an exchange be designed, among other things, to prevent fraudulent and manipulative acts and practices, to promote just and equitable principles of trade, to remove impediments to and perfect the mechanism of a free and open market and a national market system and, in general, to protect investors and the public interest, and which prohibits the rules of an exchange from being designed to permit unfair discrimination between customers, issuers, brokers, or dealers, and with Section 6(b)(8) of the Act, which requires that the rules of an exchange not impose any burden on competition not necessary or appropriate in furtherance of the purposes of the Act.28

    26Id.

    27 15 U.S.C. 78f(b)(5).

    28 15 U.S.C. 78f(b)(8).

    The Program was intended to create additional price improvement opportunities for retail investors by segmenting retail order flow on the Exchange.29 When the Commission initially approved the Program on a pilot basis, it explained that it would monitor the Program throughout the pilot period for its potential effects on public price discovery and on the broader market structure.30 The Commission expressed its view that the Program should not cause a major shift in market structure, but instead, it would closely replicate the trading dynamics that exist in the over-the-counter markets to present another competitive venue for retail order flow execution.31 As explained above, the Exchange provides an analysis of what it considers to be the economic benefits for retail investors and the marketplace flowing from operation of the Program.32 The Exchange also concludes, among other things, that the relatively modest volume in the Program limits the potential impact of the Program on the broader market quality on the Exchange, and that Program has not had any significant impact on broader market quality.33

    29 See RPI Approval Order, supra note 13, at 71655

    30See id.

    31See id. at 71656.

    32See supra notes 20—22, and Notice, supra note 3, at 41131-38.

    33See id. at 413332; 41337.

    Under the Commission's Rules of Practice, the “burden to demonstrate that a proposed rule change is consistent with the [Act] and the rules and regulations issued thereunder . . . is on the [SRO] that proposed the rule change.” 34 The description of a proposed rule change, its purpose and operation, its effect, and a legal analysis of its consistency with applicable requirements must all be sufficiently detailed and specific to support an affirmative Commission finding,35 and any failure of an SRO to provide this information may result in the Commission not having a sufficient basis to make an affirmative finding that a proposed rule change is consistent with the Act and the applicable rules and regulations.36 Moreover, “unquestioning reliance” on an SRO's representations in a proposed rule change would not be sufficient to justify Commission approval of a proposed rule change.37

    34 Rule 700(b)(3), Commission Rules of Practice, 17 CFR 201.700(b)(3).

    35See id.

    36See id.

    37See Susquehanna Int'l Group, LLP v. Securities and Exchange Commission, 866 F.3d 442, 446-47 (D.C. Cir. 2017) (rejecting the Commission's reliance on an SRO's own determinations without sufficient evidence of the basis for such determinations).

    The Commission questions whether the information and analysis provided by the Exchange support the Exchange's conclusions that the Program has achieved its goals, including whether the Program has not had a significant impact on broader market quality. The Commission seeks additional information and analysis concerning the Program's impact on the broader market; for example, additional information to support the view that the Program has not had a material adverse impact on market quality. The Commission believes it is appropriate to institute proceedings to allow for additional consideration and comment on the issues raised herein, any potential response to comments or supplemental information provided by the Exchange, and any additional independent analysis by the Commission. The Commission believes that these issues raise questions as to whether the Exchange has met its burden to demonstrate, based on the data and analysis provided, that permanent approval of the Program is consistent with the Act, and specifically, with its requirements that the Program be designed to perfect the mechanism of a free and open market and the national market system, protect investors and the public interest, and not be unfairly discriminatory; or not impose an unnecessary or inappropriate burden on competition.38

    38See 15 U.S.C. 78f(b)(4), (5), and (8).

    IV. Procedure: Request for Written Comments

    The Commission requests that interested persons provide written submissions of their views, data, and arguments with respect to the issues identified above, as well as any other concerns they may have with the proposal. In particular, the Commission invites the written views of interested persons concerning whether the proposal is consistent with Sections 6(b)(5) and 6(b)(8), or any other provision of the Exchange Act, or the rules and regulations thereunder. Although there do not appear to be any issues relevant to approval or disapproval that would be facilitated by an oral presentation of views, data, and arguments, the Commission will consider, pursuant to Rule 19b-4, any request for an opportunity to make an oral presentation.39

    39 Section 19(b)(2) of the Exchange Act, as amended by the Securities Act Amendments of 1975, Public Law 94-29 (June 4, 1975), grants the Commission flexibility to determine what type of proceeding—either oral or notice and opportunity for written comments—is appropriate for consideration of a particular proposal by a self-regulatory organization. See Securities Act Amendments of 1975, Senate Comm. on Banking, Housing & Urban Affairs, S. Rep. No. 75, 94th Cong., 1st Sess. 30 (1975).

    Interested persons are invited to submit written data, views, and arguments regarding whether the proposal should be approved or disapproved by December 12, 2018. Any person who wishes to file a rebuttal to any other person's submission must file that rebuttal by December 26, 2018.

    Comments may be submitted by any of the following methods:

    Electronic Comments

    • Use the Commission's internet comment form (http://www.sec.gov/rules/sro.shtml); or

    • Send an email to [email protected]. Please include File Number SR-CboeBYX-2018-014 on the subject line.

    Paper Comments

    • Send paper comments in triplicate to Secretary, Securities and Exchange Commission, 100 F Street NE, Washington, DC 20549-1090.

    All submissions should refer to File Number SR-CboeBYX-2018-014. The file number should be included on the subject line if email is used. To help the Commission process and review your comments more efficiently, please use only one method. The Commission will post all comments on the Commission's internet website (http://www.sec.gov/rules/sro.shtml). Copies of the submission, all subsequent amendments, all written statements with respect to the proposed rule change that are filed with the Commission, and all written communications relating to the proposed rule change between the Commission and any person, other than those that may be withheld from the public in accordance with the provisions of 5 U.S.C. 552, will be available for website viewing and printing in the Commission's Public Reference Room, 100 F Street NE, Washington, DC 20549, on official business days between the hours of 10:00 a.m. and 3:00 p.m. Copies of such filing also will be available for inspection and copying at the principal office of the Exchange. All comments received will be posted without change. Persons submitting comments are cautioned that we do not redact or edit personal identifying information from comment submissions. You should submit only information that you wish to make publicly available. All submissions should refer to File Number SR-CboeBYX-2018-014 and should be submitted on or before December 12, 2018. Rebuttal comments should be submitted by December 26, 2018.

    40 17 CFR 200.30-3(a)(57) and (58).

    For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.40

    Eduardo A. Aleman, Assistant Secretary.
    [FR Doc. 2018-25341 Filed 11-20-18; 8:45 am] BILLING CODE 8011-01-P
    SMALL BUSINESS ADMINISTRATION Data Collection Available for Public Comments ACTION:

    60-Day notice and request for comments.

    SUMMARY:

    The Small Business Administration (SBA) intends to request approval, from the Office of Management and Budget (OMB) for the collection of information described below. The Paperwork Reduction Act (PRA) requires federal agencies to publish a notice in the Federal Register concerning each proposed collection of information before submission to OMB, and to allow 60 days for public comment in response to the notice. This notice complies with that requirement.

    DATES:

    Submit comments on or before January 22, 2019.

    ADDRESSES:

    Send all comments to Daniel Upham, Chief, Microenterprise Development Division, Office of Capital Access, Small Business Administration, 409 3rd Street, Washington, DC 20416.

    FOR FURTHER INFORMATION CONTACT:

    Daniel Upham, Chief, Microenterprise Development Division, Office of Capital Access, [email protected] 202-205-7001, or Curtis B. Rich, Management Analyst, 202-205-7030, [email protected].

    SUPPLEMENTARY INFORMATION:

    Information collection is needed to ensure that Microloan Program activity meets the statutory goals of assisting mandated target market. The information is used by the reporting participants and the SBA to assist with portfolio management, risk management, loan servicing, oversight and compliance, data management and understanding of short and long term trends and development of outcome measures.

    Solicitation of Public Comments

    SBA is requesting comments on (a) Whether the collection of information is necessary for the agency to properly perform its functions; (b) whether the burden estimates are accurate; (c) whether there are ways to minimize the burden, including through the use of automated techniques or other forms of information technology; and (d) whether there are ways to enhance the quality, utility, and clarity of the information.

    Summary of Information Collection

    Title: Microloan Program Electronic Reporting System (MPERS) (MPERsystem).

    Description of Respondents: SBA reporting participants in the Microloan Program.

    Form Number: N/A.

    Total Estimated Annual Responses: 170.

    Total Estimated Annual Hour Burden: 3,080.

    Curtis Rich, Management Analyst.
    [FR Doc. 2018-25335 Filed 11-20-18; 8:45 am] BILLING CODE 8025-01-P
    SMALL BUSINESS ADMINISTRATION Data Collection Available for Public Comments ACTION:

    60-Day notice and request for comments.

    SUMMARY:

    The Small Business Administration (SBA) intends to request approval, from the Office of Management and Budget (OMB) for the collection of information described below. The Paperwork Reduction Act (PRA) requires federal agencies to publish a notice in the Federal Register concerning each proposed collection of information before submission to OMB, and to allow 60 days for public comment in response to the notice. This notice complies with that requirement.

    DATES:

    Submit comments on or before January 22, 2019.

    ADDRESSES:

    Send all comments to Cynthia Pitts, Director, Office of Disaster Assistance, Small Business Administration, 409 3rd Street, 6th Floor, Washington, DC 20416.

    FOR FURTHER INFORMATION CONTACT:

    Cynthia Pitts, Director, Office of Disaster Assistance, [email protected] 202-205-7570, or Curtis B. Rich, Management Analyst, 202-205-7030, [email protected].

    SUPPLEMENTARY INFORMATION:

    Prior to Small Business Administration (SBA) approval of subsequent loan disbursement, disaster loan borrowers are required to submit information to demonstrate that they used loan proceeds for authorized purposes only and to make certain certification regarding current financial condition and previously reported compensation paid in connection with the loan.

    Solicitation of Public Comments

    SBA is requesting comments on (a) Whether the collection of information is necessary for the agency to properly perform its functions; (b) whether the burden estimates are accurate; (c) whether there are ways to minimize the burden, including through the use of automated techniques or other forms of information technology; and (d) whether there are ways to enhance the quality, utility, and clarity of the information.

    Summary of Information Collection

    Title: Borrower's Progress Certification.

    Description of Respondents: Disaster loan Borrowers.

    Form Number: SBA Form 1366.

    Total Estimated Annual Responses: 14,218.

    Total Estimated Annual Hour Burden: 7,106.

    Curtis Rich, Management Analyst.
    [FR Doc. 2018-25348 Filed 11-20-18; 8:45 am] BILLING CODE 8025-01-P
    SMALL BUSINESS ADMINISTRATION Data Collection Available for Public Comments ACTION:

    60-Day notice and request for comments.

    SUMMARY:

    The Small Business Administration (SBA) intends to request approval, from the Office of Management and Budget (OMB) for the collection of information described below. The Paperwork Reduction Act (PRA) requires federal agencies to publish a notice in the Federal Register concerning each proposed collection of information before submission to OMB, and to allow 60 days for public comment in response to the notice. This notice complies with that requirement.

    DATES:

    Submit comments on or before January 22, 2019.

    ADDRESSES:

    Send all comments to Cynthia Pitts, Director, Office of Disaster Assistance, Small Business Administration, 409 3rd Street, 6th Floor, Washington, DC 20416.

    FOR FURTHER INFORMATION CONTACT:

    Cynthia Pitts, Director, Office of Disaster Assistance, [email protected] 202-205-7570, or Curtis B. Rich, Management Analyst, 202-205-7030, [email protected].

    SUPPLEMENTARY INFORMATION:

    A team of Quality Assurance staff at the Disaster Assistance Center (DASC) will conduct a brief telephone survey of customers to determine their satisfaction with the services received from the (DASC) and the Field Operations Centers. The result will help the Agency to improve where necessary, the delivery of critical financial assistance to disaster victims.

    Solicitation of Public Comments

    SBA is requesting comments on (a) Whether the collection of information is necessary for the agency to properly perform its functions; (b) whether the burden estimates are accurate; (c) whether there are ways to minimize the burden, including through the use of automated techniques or other forms of information technology; and (d) whether there are ways to enhance the quality, utility, and clarity of the information.

    Summary of Information Collection

    Title: Disaster Assistance Customer Satisfaction Survey.

    Description of Respondents: Disaster Customers satisfaction with service received.

    Form Number: SBA Form 2313FOC, 2313CSC.

    Total Estimated Annual Responses: 2,400.

    Total Estimated Annual Hour Burden: 199.

    Curtis Rich, Management Analyst.
    [FR Doc. 2018-25357 Filed 11-20-18; 8:45 am] BILLING CODE 8025-01-P
    DEPARTMENT OF STATE [Public Notice 10595] 60-Day Notice of Proposed Information Collection: Overseas Schools Grant Status Report ACTION:

    Notice of request for public comment.

    SUMMARY:

    The Department of State is seeking Office of Management and Budget (OMB) approval for the information collection described below. In accordance with the Paperwork Reduction Act of 1995, we are requesting comments on this collection from all interested individuals and organizations. The purpose of this notice is to allow 60 days for public comment preceding submission of the collection to OMB.

    DATES:

    The Department will accept comments from the public up to January 22, 2019.

    ADDRESSES:

    You may submit comments by any of the following methods:

    Web: Persons with access to the internet may comment on this notice by going to www.Regulations.gov. You can search for the document by entering “Docket Number: DOS-2018-0051” in the Search field. Then click the “Comment Now” button and complete the comment form.

    Email: [email protected].

    Regular Mail: Send written comments to: Office of Overseas Schools, U.S. Department of State, 2201 C Street NW, Washington, DC 20520.

    Fax: 202-261-8224.

    You must include the DS form number (if applicable), information collection title, and the OMB control number in any correspondence.

    FOR FURTHER INFORMATION CONTACT:

    Direct requests for additional information regarding the collection listed in this notice, including requests for copies of the proposed collection instrument and supporting documents, to Thomas Shearer, Department of State, Office of Overseas Schools, A/OPR/OS, Room H328, SA-1, Washington, DC 20522-0132, who may be reached on 202-261-8200 or at [email protected].

    SUPPLEMENTARY INFORMATION:

    Title of Information Collection: Overseas Schools Grant Status Report.

    OMB Control Number: 1405-0033.

    Type of Request: Extension of a currently approved collection.

    Originating Office: Bureau of Administration, A/OPR/OS.

    Form Number: DS-2028.

    Respondents: Overseas schools grantees.

    Estimated Number of Respondents: 192.

    Estimated Number of Responses: 192.

    Average Time per Response: 15 minutes.

    Total Estimated Burden Time: 48 hours.

    Frequency: Annually.

    Obligation to Respond: Required to Obtain or Retain a Benefit.

    We are soliciting public comments to permit the Department to:

    • Evaluate whether the proposed information collection is necessary for the proper functions of the Department.

    • Evaluate the accuracy of our estimate of the time and cost burden for this proposed collection, including the validity of the methodology and assumptions used.

    • Enhance the quality, utility, and clarity of the information to be collected.

    • Minimize the reporting burden on those who are to respond, including the use of automated collection techniques or other forms of information technology.

    Please note that comments submitted in response to this Notice are public record. Before including any detailed personal information, you should be aware that your comments as submitted, including your personal information, will be available for public review.

    Abstract of Proposed Collection

    The Office of Overseas Schools of the Department of State (A/OPR/OS) is responsible for determining that adequate educational opportunities exist at Foreign Service Posts for dependents of U.S. Government personnel stationed abroad, and for assisting American-sponsored overseas schools to demonstrate U.S. educational philosophy and practice. The information gathered provides the technical and professional staff of A/OPR/OS the means by which obligations, expenditures and reimbursements of the grant funds are monitored to ensure the grantee is in compliance with the terms of the grant.

    Methodology

    Information is collected via electronic and paper submission.

    Seth M. Rogier, Acting Executive Director, Bureau of Administration, Department of State.
    [FR Doc. 2018-25365 Filed 11-20-18; 8:45 am] BILLING CODE 4710-24-P
    SURFACE TRANSPORTATION BOARD [Docket No. FD 36245] Paul Didelius—Continuance in Control Exemption—KET, LLC

    Paul Didelius (Didelius), an individual and noncarrier,1 has filed a verified notice of exemption pursuant to 49 CFR 1180.2(d)(2) to continue in control of KET, LLC (KET), upon KET's becoming a Class III rail carrier.

    1 Didelius currently owns 100% of LRY, LLCd/b/a Lake Railway (LRY), a Class III carrier that leases and operates rail lines owned by Union Pacific Railroad Company and Lake County, Or., in California and Oregon; 49% of YCR Corporation (YCR), a Class III rail carrier established for the purpose of leasing and operating a line of railroad owned by Yakima County, Wash.; 100% of CCET, LLC (CCET), a Class III short line rail carrier organized for the purpose of leasing and operating a rail line owned by Norfolk Southern Railway Company in Ohio; 100% of WRL, LLC (WRL), a Class III carrier that leases and operates a rail line owned by Port of Royal Slope, a Washington state municipal corporation, in Washington; and 100% of CWW, LLC (CWW), a Class III carrier that leases and operates a line of railroad owned by the Port of Columbia, Wash.

    This transaction is related to a concurrently filed verified notice of exemption in KET, LLC—Operation Exemption—Lines of Railroad in Benton County, Wash., Docket No. FD 36244, in which KET seeks Board approval under 49 CFR 1150.31 to operate two industrial spurs totaling approximately 1.28 miles in length in Kennewick and Hedges, Benton County, Wash.

    The transaction may be consummated on or after December 5, 2018, the effective date of the exemption (30 days after the verified notice of exemption was filed).

    Didelius represents that: (1) The rail properties that will be operated and controlled by Didelius, namely LRY, YCR, CCET, WRL, CWW, and KET, do not physically connect; (2) there are no plans to acquire additional rail lines for the purpose of making a connection; and (3) each of the carriers involved in the continuance in control transaction is a Class III carrier. Therefore, the transaction is exempt from the prior approval requirements of 49 U.S.C. 11323. See 49 CFR 1180.2(d)(2).

    Under 49 U.S.C. 10502(g), the Board may not use its exemption authority to relieve a rail carrier of its statutory obligation to protect the interests of its employees. Section 11326(c), however, does not provide for labor protection for transactions under §§ 11324 and 11325 that involve only Class III rail carriers. Accordingly, the Board may not impose labor protective conditions here, because all of the carriers involved are Class III carriers.

    If the verified notice contains false or misleading information, the exemption is void ab initio. Petitions to revoke the exemption under 49 U.S.C. 10502(d) may be filed at any time. The filing of a petition to revoke will not automatically stay the effectiveness of the exemption. Petitions for stay must be filed no later than November 28, 2018 (at least seven days before the exemption becomes effective).

    An original and 10 copies of all pleadings, referring to Docket No. FD 36245, must be filed with the Surface Transportation Board, 395 E Street SW, Washington, DC 20423-0001. In addition, one copy of each pleading must be served on James H.M. Savage, 22 Rockingham Court, Germantown, MD 20874.

    Board decisions and notices are available on our website at www.stb.gov.

    Decided: November 16, 2018.

    By the Board, Scott M. Zimmerman, Acting Director, Office of Proceedings.

    Jeffrey Herzig, Clearance Clerk.
    [FR Doc. 2018-25413 Filed 11-20-18; 8:45 am] BILLING CODE 4915-01-P
    SURFACE TRANSPORTATION BOARD [Docket No. FD 36220] CSX Transportation, Inc.—Lease—Western and Atlantic Railroad AGENCY:

    Surface Transportation Board.

    ACTION:

    Decision No. 1 in FD 36220; Notice of Acceptance of Application; Issuance of Procedural Schedule.

    SUMMARY:

    This decision accepts for consideration the application by CSX Transportation, Inc. to continue to lease approximately 137.33 miles of rail line of the Western and Atlantic Railroad from the State of Georgia. The Board determines that this is a minor transaction as defined by the Board's regulations and adopts a procedural schedule.

    DATES:

    The effective date of this decision is November 21, 2018. Any person who wishes to participate in this proceeding as a party of record (POR) must file a notice of intent to participate no later than December 5, 2018. All comments, protests, requests for conditions, and any other evidence and argument in opposition to the application, including filings by the U.S. Department of Justice (DOJ) and the U.S. Department of Transportation (DOT), must be filed by January 4, 2019. Responses to comments, protests, requests for conditions, and other opposition on the transportation merits of the Lease, and rebuttal in support of the application must be filed by February 1, 2019.

    The Board expects to issue its final decision by April 19, 2019, and to make the decision effective by May 19, 2019. For further information respecting dates, see the procedural schedule below.

    ADDRESSES:

    Any filing submitted on the transportation merits in this proceeding must be submitted either via the Board's e-filing format or in the traditional paper format. Any person using e-filing should attach a document and otherwise comply with the instructions found on the Board's website at www.stb.gov at the “E-FILING” link. Any person submitting a filing in the traditional paper format should send an original and 10 paper copies of the filing (and also an electronic version) to: Surface Transportation Board, 395 E Street SW, Washington, DC 20423-0001. In addition, one copy of each filing in this proceeding must be sent (and may be sent by email only if service by email is acceptable to the recipient) to each of the following: (1) U.S. Secretary of Transportation, 1200 New Jersey Avenue SE, Washington, DC 20590; (2) Attorney General of the United States, c/o Assistant Attorney General, Antitrust Division, Room 3109, Department of Justice, Washington, DC 20530; (3) Louis E. Gitomer (representing CSXT), Law Offices of Louis E. Gitomer, LLC, 600 Baltimore Avenue, Suite 301, Towson, MD 21204; and (4) any other person designated as a POR on the service list notice (as explained below, the service list notice will be issued as soon after December 5, 2018, as practicable).

    FOR FURTHER INFORMATION CONTACT:

    Lisa Novins, (202) 245-0389. Assistance for the hearing impaired is available through the Federal Information Relay Service (FIRS) at 1-800-877-8339.

    SUPPLEMENTARY INFORMATION:

    The Surface Transportation Board (Board) is accepting for consideration the application submitted on October 22, 2018, by CSX Transportation, Inc. (CSXT). CSXT seeks Board approval under 49 U.S.C. 11323 to continue to lease from the State of Georgia (Georgia) approximately 137.33 miles of rail line of the Western and Atlantic Railroad (W&A), a non-operating carrier owned by Georgia, acting by and through the State Properties Commission, between milepost 0 at Central Avenue in the City of Atlanta, Ga., and milepost 137.28 at the centerline of Interstate 24 in the City of Chattanooga, Tenn. (the Line). On November 2, 2018, Georgia, acting by and through the State Properties Commission, filed a letter in support of CSXT's application.

    The Board finds that the proposed transaction (the Lease) is a “minor transaction” under 49 CFR 1180.2(c) and that the application is complete. The Board adopts a procedural schedule for consideration of the application, under which the Board's final decision would be expected to be issued by April 19, 2019, and would become effective by May 19, 2019.

    As a condition to the Lease, CSXT states that it has agreed to seek authority to abandon two lines that are not part of the Line in order to allow Georgia to expand its Silver Comet recreational trail: (1) A 2.32-mile long railroad line between milepost S.G. 579.29 and milepost S.G. 581.61 in Cobb County, Ga., see CSX Transportation, Inc.—Abandonment Exemption—in Cobb County, Ga., AB 55 (Sub-No. 784X); and (2) a 4.3-mile line between milepost S.G. 579.29 and milepost 575.00 in Cobb County, Ga. (Appl. 18.)

    CSXT is a Class I railroad and W&A is a non-operating Class III railroad that is owned by Georgia, acting by and through the State Properties Commission. (Appl. 3, 5.) According to CSXT, it and its predecessors have been the only railroads operating the Line since 1890. (Id. at 4.) CSXT states that it provides overhead and local service over the Line, that the Norfolk Southern Railway Company (NSR) intersects with the Line in Chattanooga, Tenn., and Dalton, Ga.,1 and that CSXT interchanges traffic in Elizabeth, Ga., with the Georgia Northeastern Railroad Company, Inc. (GNRR). (Id.) CSXT states that the current lease expires on December 31, 2019, and that the new lease for the Line is for an additional 50 years. (Id. at 14, 17.) CSXT further states that it will retain responsibility for dispatching, track maintenance, capital improvements, and serving shippers under the Lease. (Id. at 14.)

    1 CSXT does not indicate whether it interchanges traffic with NSR at these locations.

    Discontinuances/Abandonments. CSXT states that it does not anticipate discontinuing service over or abandoning the Line or any portion of the Line. (Appl. 18.) However, CSXT has agreed to seek authority to abandon two of its lines that are not part of the Line to allow Georgia to expand its Silver Comet recreational trail, which is a material condition of the Lease. (Appl. 18, citing id. at Ex. 2, Lease, section 11.03.) On October 15, 2018, CSXT filed a verified notice of exemption under 49 CFR pt. 1152 subpart F—Exempt Abandonments to abandon the 2.32-mile line between milepost S.G. 579.29 and milepost S.G. 581.61 in Cobb County, Ga. in Docket No. AB 55 (Sub-No. 784X), CSX Transportation, Inc.—Abandonment Exemption—in Cobb County, Ga. Notice of the exemption was served and published in the Federal Register on November 2, 2018 (83 FR 55,232). The exemption is scheduled to become effective on December 2, 2018. CSXT states that, if the abandonment is granted, CSXT intends to enter into a trail use agreement with Georgia under the National Trails System Act, 16 U.S.C. 1247(d). (Appl. 18.) With respect to the second line,2 CSXT states that, in the Lease, CSXT has granted Georgia or its Department of Transportation a first right of refusal to acquire the 4.3-mile line between milepost S.G. 579.29 and milepost 575.00 in Cobb County, Ga. According to CSXT, that line must be acquired within three years of CSXT obtaining abandonment authority. (Id.)

    2 As of the decided date of this decision, CSXT has not filed for abandonment authority for this line.

    Financial Arrangements. According to CSXT, no new securities will be issued in connection with the Lease. (Appl. 8.) CSXT states that, under the Lease, CSXT would pay Georgia a monthly rental of $1,008,333.33, which would increase annually by 2.5% compounded. Additionally, CSXT states that, by July 31 of each year, it would pay Georgia additional rent consisting of 50% of the revenue generated from all agreements, subleases, easements, or licenses attributable to the Line for the previous year. CSXT states that it will not incur any fixed charges as a result of the Lease. (Id. at 10.)

    Public Interest Considerations. CSXT states that it expects the transaction to be competitively neutral and that it will not result in any lessening of competition, creation of a monopoly, or restraint of trade in freight surface transportation in any region of the United States. (Appl. 9.) In support, CSXT states that competition with NSR between Atlanta and Chattanooga will be maintained at the current level and that the Lease will not impact motor carriers operating between Atlanta and Chattanooga on Interstate 75 or intermodal competition at intermediate points. (Id.) CSXT further states that the number of rail carriers serving each shipper on the Line will remain the same and that no shipper now being served by two railroads would have its service limited to one railroad. (Id.)

    According to CSXT, the Lease will maintain the status quo of the transportation services to rail customers now served by CSXT, as CSXT will continue to serve shippers as it does today. (Appl. 10.) CSXT states that it will continue to provide essential transportation services as it and its predecessors have done since 1890, and that essential services provided by other carriers will not be affected by the Lease. (Id. at 8, 10.)

    CSXT states that, under the Lease, Georgia has reserved rights that may require the relocation of track, but CSXT is confident that its ability to provide adequate transportation service is protected by the terms of the Lease, which states that any track relocation will not “unreasonably interfere with the use by [CSXT] of the Leased Property, or unreasonably reduce [CSXT's] operating capacity.” (Appl. 10, citing id. at Ex. 2, Lease, section 1.04(c).) Additionally, CSXT states that Georgia has reserved the right to institute passenger rail service over the Line “subject to the mutual agreement of [Georgia] and [CSXT] with respect to the impact any such passenger rail may have upon the safety and capacity of, compensation for, and liability in connection with the [Line].” (Id. at 11, citing id. at Ex. 2, Lease, section 11.01.)

    Time Schedule for Consummation. CSXT states that, pursuant to the Lease, the transaction is scheduled to be consummated January 1, 2020. (Appl. 8.)

    Environmental Impacts. CSXT states that the Lease does not require environmental documentation and review under 49 CFR 1105.6(c) because the Lease will not result in CSXT's operations over the Line exceeding the thresholds in 49 CFR 1105.7(e)(4) and (5). (Appl. 15-16.)

    Historic Preservation Impacts. CSXT states that the Lease does not require an historic report under 49 CFR 1105.8(b) because the Lease “is for the purpose of continued rail operations where further [Board] approval is required to abandon any service and there are no plans to dispose of or alter properties subject to [Board] jurisdiction that are 50 years or older.” (Appl. 17.) CSXT states that it will continue to operate the Line that it has operated for over 120 years. (Appl. 17.)

    Labor Impacts. CSXT states that there will be no impact on its employees or on the employees of W&A, because CSXT does not plan to change operations on the Line. Further, CSXT states that there are no W&A employees on the Line. CSXT requests that the Board impose the labor protective conditions set forth in Mendocino Coast Railway, Inc.—Lease and Operate—California Western Railroad, 360 I.C.C. 653 (1980), as clarified in Wilmington Terminal Railroad, Inc.—Purchase and Lease—CSX Transportation, Inc., 6 I.C.C.2d 799, 814-826 (1990). (Appl. 11.)

    Application Accepted. A transaction that does not involve the control or merger of two or more Class I railroads is not of regional or national transportation significance, and therefore is classified as “minor” if: (1) The transaction would clearly not have anticompetitive effects, or (2) any anticompetitive effects would clearly be outweighed by the transaction's contribution to the public interest in meeting significant transportation needs. A transaction not involving the control or merger of two or more Class I railroads is “significant” if neither of these determinations can be clearly made. See 49 CFR 1180.2(b), (c).

    Based on a review of the application, the Board finds that the proposed Lease would be a “minor transaction” under 49 CFR 1180.2(c). Nothing in the record thus far suggests that the Lease would have anticompetitive effects, because the Lease proposes to generally maintain the status quo by allowing CSXT to continue operating over the Line as it and its predecessors have done since 1890. The application indicates that, not only would CSXT continue to operate over the Line, but NSR and GNRR would “retain their existing rights.” (Appl. 6.) It does not appear, under the terms of the proposed Lease, that any shipper would have fewer competitive rail alternatives as a result of the transaction.

    The Board's finding regarding competitive impact is preliminary. The Board will give careful consideration to any claims that any potential anticompetitive effects of the Lease would not be outweighed by its potential benefits.

    The Board accepts the application for consideration because it is in substantial compliance with the applicable regulations governing “minor transactions.” See 49 CFR 1180; 49 U.S.C. 11321-26. The Board reserves the right to require the filing of supplemental information as necessary to complete the record.

    Procedural Schedule. Any person who wishes to participate in this proceeding as a POR must file a notice of intent to participate no later than December 5, 2018; requests for discovery from CSXT are due by December 5, 2018; CSXT's discovery responses are due by December 19, 2018; all comments, protests, requests for conditions, and any other evidence and argument in opposition to the application, including filings by DOJ and DOT, must be filed by January 4, 2019; and responses to comments, protests, requests for conditions, and other opposition on the transportation merits of the Lease, as well as CSXT's rebuttal in support of the application, must be filed by February 1, 2019. The Board reserves the right to adjust the schedule as circumstances may warrant. For further information regarding dates, see the procedural schedule below.

    Notice of Intent To Participate. Any person who wishes to participate in this proceeding as a POR must file with the Board, no later than December 5, 2018, a notice of intent to participate, accompanied by a certificate of service indicating that the notice has been properly served on the U.S. Secretary of Transportation, the Attorney General of the United States, and Mr. Gitomer (representing CSXT), as described above.

    If a request is made in the notice of intent to participate to have more than one name added to the service list as a POR representing a particular entity, the extra name will be added to the service list as a “non-party.” The list will reflect the Board's policy of allowing only one official representative per party to be placed on the service list, as specified in Press Release No. 97-68 dated August 18, 1997, announcing the implementation of the Board's “One Party-One Representative” policy for service lists. Any person designated as a non-party will receive copies of Board decisions, orders, and notices but not copies of official filings. Persons seeking to change their status must accompany that request with a written certification that he or she has complied with the service requirements set forth at 49 CFR 1180.4, and any other requirements set forth in this decision.

    Service List Notice. The Board will serve, as soon after December 5, 2018, as practicable, a notice containing the official service list (the service list notice). Each POR will be required to serve upon all other PORs, within 10 days of the service date of the service list notices, copies of all filings previously submitted by that party (to the extent such filings have not previously been served upon such other parties). Each POR will also be required to file with the Board, within 10 days of the service date of the service list notice, a certificate of service indicating that the service required by the preceding sentence has been accomplished. Every filing made by a POR must have its own certificate of service indicating that all PORs on the service list have been served with a copy of the filing. Members of the United States Congress (MOCs) and Governors (GOVs) are not parties of record and need not be served with copies of filings, unless any MOC or GOV has requested to be, and is designated, as a POR.

    Service of Decisions, Order, and Notices. The Board will serve copies of its decisions, orders, and notices on those persons who are designated on the official service list as either POR, MOC, GOV, or non-party. All other interested persons are encouraged to secure copies of decisions, orders, and notices via the Board's website at www.stb.gov under “E-LIBRARY/Decisions & Notices.”

    Access to Filings. Under the Board's rules, any document filed with the Board (including applications, pleadings, etc.) shall be promptly furnished to interested persons on request, unless subject to a protective order. 49 CFR 1180.4(a)(3). The application and other filings in this proceeding are available on the Board's website at www.stb.gov under “E-LIBRARY/Filings.” In addition, the application may be obtained from Mr. Gitomer at the address indicated above.

    Procedural Schedule October 22, 2018 Application filed. December 5, 2018 Notices of intent to participate in this proceeding due. Discovery requests due to CSXT. December 19, 2018 CSXT's responses to discovery requests due. January 4, 2019 Comments due from all parties, including the U.S. Secretary of Transportation and the Attorney General, on the transportation merits of the Lease. February 1, 2019 Responses to comments on the transportation merits of the Lease due. CSXT's rebuttal in support of the application due. March 6, 2019 Close of record on the transportation merits. April 19, 2019 Date by which a final decision will be served. May 19, 2019 Date by which a final decision will become effective.

    It is ordered:

    1. The application in FD 36220 is accepted for consideration.

    2. The parties to this proceeding must comply with the procedural schedule adopted by the Board in this proceeding as shown in the procedural schedule above and must comply with the procedural requirements described in this decision.

    3. This decision is effective on its service date.

    Decided: November 16, 2018.

    By the Board, Board Members Begeman and Miller.

    Aretha Laws-Byrum, Clearance Clerk.
    [FR Doc. 2018-25388 Filed 11-20-18; 8:45 am] BILLING CODE 4915-01-P
    SURFACE TRANSPORTATION BOARD [Docket No. FD 36244] KET, LLC—Operation Exemption—Lines of Railroad in Benton County, Wash.

    KET, LLC (KET), a noncarrier, has filed a verified notice of exemption under 49 CFR 1150.31 to operate two industrial spurs1 totaling approximately 1.28 miles of track in Kennewick and Hedges, Benton County, Wash.:

    1 KET states that it acquired the industrial spurs from the Port of Kennewick, Washington on July 23, 2013. According to KET, the industrial spurs will have no mileposts.

    (1) The Kennewick track includes the following: A main industrial spur in the City of Kennewick originating at the connection with the Union Pacific Railroad Company (UP) “City Lead” (connecting at its west end to UP's Kalan Industrial Lead) from the east edge of Washington St., running along the line of Bruneau Ave. extending in an easterly direction and terminating east of the intersection of Bruneau Ave. and Kingwood St. This main industrial rail spur also connects with BNSF Railway Company (BNSF) along Bruneau Ave. west of the intersection with N Elm St. The main industrial rail spur is 3,694 feet (approximately 0.7 miles) in length. A branch spur (Ash Grove Spur) diverges from the main industrial rail spur along the line extending east on Bruneau Ave., east of its intersection with N. Gum St. and proceeding in a northeasterly direction, terminating on the property of the Ash Grove Cement Co. at 633 N Ivy Street in Kennewick. The branch spur is 1,476 feet (approximately 0.28 miles) in length. The total length of the Kennewick track is 5,170 feet (0.98 miles).

    (2) The Hedges track originates at the connection with UP and runs southeast to the property line of Nutrien Chemical Company, a distance of approximately 1,600 feet (0.30 miles).

    This transaction is related to a concurrently filed verified notice of exemption in Paul Didelius—Continuance in Control Exemption—KET, LLC, Docket No. FD 36245, in which Paul Didelius seeks Board approval to continue in control of KET under 49 CFR 1180.2(d)(2) upon KET's becoming a Class III rail carrier.

    KET certifies that the projected annual revenues as a result of this transaction will remain less than $5 million dollars annually. KET states that no interchange commitments are contemplated for this transaction.

    The transaction may be consummated on or after December 5, 2018, the effective date of the exemption (30 days after the verified notice of exemption was filed). If the verified notice contains false or misleading information, the exemption is void ab initio. Petitions to revoke the exemption under 49 CFR 10502(d) may be filed at any time. The filing of a petition to revoke will not automatically stay the effectiveness of the exemption. Petitions to stay must be filed by November 28, 2018 (at least seven days before the exemption becomes effective).

    An original and 10 copies of all pleadings referring to Docket No. FD 36244 must be filed with the Surface Transportation Board, 395 E Street SW, Washington, DC 20423-0001. In addition, a copy of each pleading must be served on applicant's representative, James H.M. Savage, 22 Rockingham Court, Germantown, MD 20874.

    According to KET, this action is categorically excluded from environmental review under 49 CFR 1105.6(c).

    Board decisions and notices are available on our website at www.stb.gov.

    Decided: November 16, 2018.

    By the Board, Scott M. Zimmerman, Acting Director, Office of Proceedings.

    Jeffrey Herzig, Clearance Clerk.
    [FR Doc. 2018-25418 Filed 11-20-18; 8:45 am] BILLING CODE 4915-01-P
    DEPARTMENT OF TRANSPORTATION Federal Aviation Administration Agency Information Collection Activities: Requests for Comments; Clearance of Renewed Approval of Information Collection: Pilot Certification and Qualification Requirements for Air Carrier Operations AGENCY:

    Federal Aviation Administration (FAA), DOT.

    ACTION:

    Notice and request for comments.

    SUMMARY:

    In accordance with the Paperwork Reduction Act of 1995, FAA invites public comments about our intention to request the Office of Management and Budget (OMB) approval to renew an information collection. The Federal Register Notice with a 60-day comment period soliciting comments on the following collection of information was published on July 31, 2018. The collection involves FAA review of Airline Transport Pilot (ATP) Certification Training Program (CTP) submittals to determine that the program complies with the applicable requirements. It also involves FAA review of an institution of higher education's application for the authority to certify its graduates meet the minimum regulatory requirements.

    DATES:

    Written comments should be submitted by December 21, 2018.

    ADDRESSES:

    Interested persons are invited to submit written comments on the proposed information collection to the Office of Information and Regulatory Affairs, Office of Management and Budget. Comments should be addressed to the attention of the Desk Officer, Department of Transportation/FAA, and sent via electronic mail to [email protected], or faxed to (202) 395-6974, or mailed to the Office of Information and Regulatory Affairs, Office of Management and Budget, Docket Library, Room 10102, 725 17th Street NW, Washington, DC 20503.

    FOR FURTHER INFORMATION CONTACT:

    Barbara Hall at (940) 594-5913, or by email at: [email protected].

    SUPPLEMENTARY INFORMATION:

    Public Comments Invited: You are asked to comment on any aspect of this information collection, including (a) Whether the proposed collection of information is necessary for FAA's performance; (b) the accuracy of the estimated burden; (c) ways for FAA to enhance the quality, utility and clarity of the information collection; and (d) ways that the burden could be minimized without reducing the quality of the collected information. The agency will summarize and/or include your comments in the request for OMB's clearance of this information collection.

    OMB Control Number: 2120-0755.

    Title: Pilot Certification and Qualification Requirements for Air Carrier Operations.

    Form Numbers: 8700-1.

    Type of Review: This is a renewal of an information collection.

    Background: The Federal Register Notice with a 60-day comment period soliciting comments on the following collection of information was published on July 31, 2018 (83 FR 37039). FAA aviation safety inspectors review the Airline Transport Pilot (ATP) Certification Training Program (CTP) submittals to determine that the program complies with the applicable requirements of 14 CFR 61.156. The programs that comply with the minimum requirements receive approval to begin offering the course to applicants for an ATP certificate with a multiengine class rating or an ATP certificate obtained concurrently with an airplane type rating. FAA aviation inspectors also review an institution of higher education's application for the authority to certify its graduates meet the minimum requirements of 14 CFR 61.160. The institutions of higher education that receive a letter of authorization for their degree program(s) are authorized to place a certifying statement on a graduates' transcript indicating he or she is eligible for a restricted privileges ATP certificate.

    Respondents: 41.

    Frequency: On occasion.

    Estimated Average Burden per Response: 3.1 hours.

    Estimated Total Annual Burden: 980 hours.

    Issued in Washington, DC, on November 15, 2018. Barbara Hall, FAA Information Collection Clearance Officer, IT Enterprises Business Services Division, ASP-110.
    [FR Doc. 2018-25360 Filed 11-20-18; 8:45 am] BILLING CODE 4910-13-P
    DEPARTMENT OF TRANSPORTATION Federal Aviation Administration Agency Information Collection Activities: Requests for Comments; Clearance of Renewed Approval of Information Collection: Certification of Airports AGENCY:

    Federal Aviation Administration (FAA), DOT.

    ACTION:

    Notice and request for comments.

    SUMMARY:

    In accordance with the Paperwork Reduction Act of 1995, FAA invites public comments about our intention to request the Office of Management and Budget (OMB) approval to renew an information collection. The Federal Register Notice with a 60-day comment period soliciting comments on the following collection of information was published on July 31, 2018. The collection involves FAA Form 5280-1, Application for Airport Operating Certificate. Every airport that wants to become a certificated airport must complete this form, as well as provide a draft Airport Certification Manual (ACM). In addition, currently certificated airports must maintain their ACM, as well as keep and maintain records related to training, self-inspection, and other requirements.

    These records allow the FAA to verify compliance with regulation safety and operational requirements to ensure that the airports meet the minimum safety requirements, which in turn enhances the safety of the flying public.

    DATES:

    Written comments should be submitted by December 21, 2018.

    ADDRESSES:

    Interested persons are invited to submit written comments on the proposed information collection to the Office of Information and Regulatory Affairs, Office of Management and Budget. Comments should be addressed to the attention of the Desk Officer, Department of Transportation/FAA, and sent via electronic mail to [email protected], or faxed to (202) 395-6974, or mailed to the Office of Information and Regulatory Affairs, Office of Management and Budget, Docket Library, Room 10102, 725 17th Street NW, Washington, DC 20503.

    FOR FURTHER INFORMATION CONTACT:

    Barbara Hall at (940) 594-5913, or by email at: [email protected].

    SUPPLEMENTARY INFORMATION:

    Public Comments Invited: You are asked to comment on any aspect of this information collection, including (a) Whether the proposed collection of information is necessary for FAA's performance; (b) the accuracy of the estimated burden; (c) ways for FAA to enhance the quality, utility and clarity of the information collection; and (d) ways that the burden could be minimized without reducing the quality of the collected information. The agency will summarize and/or include your comments in the request for OMB's clearance of this information collection.

    OMB Control Number: 2120-0675.

    Title: Certification of Airports, 14 CFR part 139.

    Form Numbers: FAA Form 5280-1.

    Type of Review: Renewal of an information collection.

    Background: The Federal Register Notice with a 60-day comment period soliciting comments on the following collection of information was published on July 31, 2018 (83 FR 37042). The statutory authority to issue airport operating certificates to airports serving certain air carriers and to establish minimum safety standards for the operation of those airports is currently found in Title 49, United States Code (U.S.C.) 44706, Airport operation certificates. The FAA uses this authority to issue requirements for the certification and operation of certain airports that service commercial air carriers. These requirements are contained in Title 14, Code of Federal Regulation part 139 (14 CFR part 139), Certification and Operations: Land Airports Serving Certain Air Carriers, as amended. 14 CFR part 139 establishes certification requirements for airports serving scheduled air carrier operations in aircraft with 10-30 seats. Information collection requirements are used by the FAA to determine an airport operator's compliance with part 139 safety and operational requirements, and to assist airport personnel to perform duties required under the regulation.

    Operators of certificated airports are required to complete FAA Form 5280—1 and develop, and comply with, a written document, an Airport Certification Manual (ACM), that details how an airport will comply with the requirements of part 139. The ACM shows the means and procedures whereby the airport will be operated in compliance with part 139, plus other instructions and procedures to help personnel concerned with operation of the airport to perform their duties and responsibilities.

    When an airport satisfactorily complies with such requirements, the FAA issues to that facility an airport operating certificate (AOC) that permits an airport to serve air carriers. The FAA periodically inspects these airports to ensure continued compliance with part 139 safety requirements, including the maintenance of specified records. Both the application for an AOC and annual compliance inspections require operators of certificated airports to collect and report certain operational information. The AOC remains in effect as long as the need exists and the operator complies with the terms of the AOC and the ACM.

    The likely respondents to new information requests are those civilian U.S. airport certificate holders who operate airports that serve scheduled and unscheduled operations of air carrier aircraft with more than 30 passenger seats (approximately 530 airports). These airport operators already hold an AOC and comply with all current information collection requirements.

    Operators of certificated airports are permitted to choose the methodology to report information and can design their own recordkeeping system. As airports vary in size, operations and complexities, the FAA has determined this method of information collection allows airport operators greater flexibility and convenience to comply with reporting and recordkeeping requirements. 100% of the information may be submitted electronically.

    The FAA has an automated system, the Certification and Compliance Management Information System (CCMIS), which allows FAA airport safety and certification inspectors to enter into a national database airport inspection information. This information is monitored to detect trends and developing safety issues, to allocate inspection resources, and generally, to be more responsive to the needs of regulated airports.

    Respondents: Approximately 530 airports.

    Frequency: Information collected on occasion.

    Estimated Average Burden per Response: 22 hours.

    Estimated Total Annual Burden: 95,191 hours.

    Issued in Washington, DC, on November 15, 2018. Barbara Hall, FAA Information Collection Clearance Officer, Performance, Policy, and Records Management Branch, ASP-110.
    [FR Doc. 2018-25361 Filed 11-20-18; 8:45 am] BILLING CODE 4910-13-P
    DEPARTMENT OF TRANSPORTATION Federal Aviation Administration [Summary Notice No. PE-2018-88] Petition for Exemption; Summary of Petition Received; Delta Air Lines, Inc. AGENCY:

    Federal Aviation Administration (FAA), DOT.

    ACTION:

    Notice of petition for exemption received.

    SUMMARY:

    This notice contains a summary of a petition seeking relief from specified requirements of Federal Aviation Regulations. The purpose of this notice is to improve the public's awareness of, and participation in, the FAA's exemption process. Neither publication of this notice nor the inclusion or omission of information in the summary is intended to affect the legal status of the petition or its final disposition.

    DATES:

    Comments on this petition must identify the petition docket number and must be received on or before December 11, 2018.

    ADDRESSES:

    Send comments identified by docket number FAA-2018-0948 using any of the following methods:

    Federal eRulemaking Portal: Go to http://www.regulations.gov and follow the online instructions for sending your comments electronically.

    Mail: Send comments to Docket Operations, M-30; U.S. Department of Transportation (DOT), 1200 New Jersey Avenue SE, Room W12-140, West Building Ground Floor, Washington, DC 20590-0001.

    Hand Delivery or Courier: Take comments to Docket Operations in Room W12-140 of the West Building Ground Floor at 1200 New Jersey Avenue SE, Washington, DC, between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays.

    Fax: Fax comments to Docket Operations at 202-493-2251.

    Privacy: In accordance with 5 U.S.C. 553(c), DOT solicits comments from the public to better inform its rulemaking process. DOT posts these comments, without edit, including any personal information the commenter provides, to http://www.regulations.gov, as described in the system of records notice (DOT/ALL-14 FDMS), which can be reviewed at http://www.dot.gov/privacy.

    Docket: Background documents or comments received may be read at http://www.regulations.gov at any time. Follow the online instructions for accessing the docket or go to the Docket Operations in Room W12-140 of the West Building Ground Floor at 1200 New Jersey Avenue SE, Washington, DC, between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays.

    FOR FURTHER INFORMATION CONTACT:

    Maria G. Delgado, AIR-673, Federal Aviation Administration, 2200 South 216th Street, Des Moines, WA 98198, phone 206-231-3178, email [email protected]; or Alphonso Pendergrass, ARM-200, Office of Rulemaking, Federal Aviation Administration, 800 Independence Avenue SW, Washington, DC 20591, phone 202-267-4713, email [email protected].

    This notice is published pursuant to 14 CFR 11.85.

    Issued in Des Moines, Washington, on November 15, 2018. Chris R. Parker, Acting Manager, Transport Standards Branch. Petition for Exemption

    Docket No.: FAA-2018-0948.

    Petitioner: Delta Air Lines, Inc.

    Section(s) of 14 CFR Affected: § 121.310(b)(2)(ii).

    Description of Relief Sought: Delta is seeking relief from 14 CFR 121.310(b)(2)(ii), which requires passenger emergency exit markings to be manufactured to meet the interior emergency exit marking requirements under which the airplane was type certificated. Specifically, Delta is proposing the use of graphical/symbolic exit signs rather than the conventional, red text-based signs on its Boeing Model 767-400ER series airplanes.

    [FR Doc. 2018-25364 Filed 11-20-18; 8:45 am] BILLING CODE 4910-13-P
    DEPARTMENT OF TRANSPORTATION Federal Aviation Administration Agency Information Collection Activities: Requests for Comments; Clearance of Renewed Approval of Information Collection: Report of Inspections Required by Airworthiness Directives AGENCY:

    Federal Aviation Administration (FAA), DOT.

    ACTION:

    Notice and request for comments.

    SUMMARY:

    In accordance with the Paperwork Reduction Act of 1995, FAA invites public comments about our intention to request the Office of Management and Budget (OMB) approval to renew an information collection. The Federal Register Notice with a 60-day comment period soliciting comments on the following collection of information was published on September 19, 2018. Airworthiness Directives are regulations issued to require corrective action to resolve an unsafe condition in aircraft, engines, propellers, and appliances. Reports of inspections are often needed when emergency corrective action is taken to determine if the action was adequate to correct the unsafe condition. The respondents are aircraft owners and operators.

    DATES:

    Written comments should be submitted by December 21, 2018.

    ADDRESSES:

    Interested persons are invited to submit written comments on the proposed information collection to the Office of Information and Regulatory Affairs, Office of Management and Budget. Comments should be addressed to the attention of the Desk Officer, Department of Transportation/FAA, and sent via electronic mail to [email protected], or faxed to (202) 395-6974, or mailed to the Office of Information and Regulatory Affairs, Office of Management and Budget, Docket Library, Room 10102, 725 17th Street NW, Washington, DC 20503.

    FOR FURTHER INFORMATION CONTACT:

    Barbara Hall at (940) 594-5913, or by email at: [email protected].

    SUPPLEMENTARY INFORMATION:

    Public Comments Invited: You are asked to comment on any aspect of this information collection, including (a) Whether the proposed collection of information is necessary for FAA's performance; (b) the accuracy of the estimated burden; (c) ways for FAA to enhance the quality, utility and clarity of the information collection; and (d) ways that the burden could be minimized without reducing the quality of the collected information. The agency will summarize and/or include your comments in the request for OMB's clearance of this information collection.

    OMB Control Number: 2120-0056.

    Title: Report of Inspections Required by Airworthiness Directives.

    Form Numbers: There are no FAA forms associated with this collection.

    Type of Review: Renewal of an information collection.

    Background: The Federal Register Notice with a 60-day comment period soliciting comments on the following collection of information was published on September 19, 2018 (83 FR 47397). Title 14 CFR part 39, Airworthiness Directives (AD), authorized by §§ 40113(a), 44701, and 44702 of Title 49 United States Code, prescribes how the FAA issues ADs.

    The FAA issues ADs when an unsafe condition is discovered on a specific aircraft type. Specific information may be required from aircraft owners/operators if an unsafe condition requires more information to develop corrective action. If it is necessary for the aircraft manufacturer or airworthiness authority to evaluate the information, owners/operators will be instructed to send the information to them.

    Respondents: Approximately 1,120 aircraft owners/operators.

    Frequency: Information is collected on occasion.

    Estimated Average Burden per Response: 1 hour.

    Estimated Total Annual Burden: 28,000 hours.

    Issued in Washington, DC, on November 15, 2018. Barbara Hall, FAA Information Collection Clearance Officer, Performance, Policy, and Records Management Branch, ASP-110.
    [FR Doc. 2018-25359 Filed 11-20-18; 8:45 am] BILLING CODE 4910-13-P
    DEPARTMENT OF TRANSPORTATION [DOT-OST-2018-0174] Department of Transportation Advisory Committee on Human Trafficking; Notice of Public Meeting AGENCY:

    Office of the Secretary of Transportation, Department of Transportation.

    ACTION:

    Notice of public meeting.

    SUMMARY:

    This notice announces a meeting of the Department of Transportation Advisory Committee on Human Trafficking.

    DATES:

    The meeting will be held on December 6, 2018, from 9:30 a.m. to 5:00 p.m. EDT.

    ADDRESSES:

    The meeting will be held at the U.S. Department of Transportation, 1200 New Jersey Avenue SE, Washington, DC 20590. Individuals wishing for audio participation and any person requiring accessibility accommodations should contact the Official listed in the next section.

    FOR FURTHER INFORMATION CONTACT:

    David Short, Designated Federal Officer, U.S. Department of Transportation, at [email protected] or (202) 366-8822. Also visit the ACHT internet website at https://www.transportation.gov/stophumantrafficking/acht.

    SUPPLEMENTARY INFORMATION: I. Background

    ACHT was created in accordance with Section 5 of the Combating Human Trafficking in Commercial Vehicles Act (Pub. L. 115-99) to make recommendations to the Secretary of Transportation on actions the Department can take to help combat human trafficking, and to develop recommended best practices for States and State and local transportation stakeholders in combatting human trafficking.

    II. Agenda

    At the December 6, 2018, meeting, the agenda will cover the following topics:

    • Welcome and Introductions • ACHT Overview and Requirements • DOT's Counter-Trafficking Initiatives • Public Participation • Subcommittees, Next Steps, and Timeline

    A final agenda will be posted on the ACHT internet website at https://www.transportation.gov/stophumantrafficking/acht at least one week in advance of the meeting.

    III. Public Participation

    The meeting will be open to the public on a first-come, first served basis, as space is limited. Members of the public who wish to attend in-person are asked to register, including name and affiliation, to [email protected] by November 26, 2018. Individuals requesting accessibility accommodations, such as sign language, interpretation, or other ancillary aids, may do so via email at: [email protected] by November 26, 2018.

    There will be 30 minutes allotted for oral comments from members of the public joining the meeting. To accommodate as many speakers as possible, the time for public comments may be limited. Individuals wishing to reserve speaking time during the meeting must submit a request at the time of registration, as well as the name, address, and organizational affiliation of the proposed speaker. If the number of registrants requesting to make statements is greater than can be reasonably accommodated during the meeting, the Office of the Secretary may conduct a lottery to determine the speakers. Speakers are requested to submit a written copy of their prepared remarks by 5:00 p.m. EDT on November 26, 2018, for inclusion in the meeting records and for circulation to ACHT members. Written comments timely submitted from those not selected to speak will nonetheless be accepted and considered as part of the record.

    Persons who wish to submit written comments for consideration by ACHT during the meeting must submit them no later than 5:00 p.m. EDT on November 26, 2018, to ensure transmission to ACHT prior to the meeting. Comments received after that date and time will be distributed to the members but may not be reviewed prior to the meeting.

    Copies of the meeting minutes will be available on the ACHT internet website at https://www.transportation.gov/stophumantrafficking/acht.

    Dated: November 15, 2018. Joel Szabat, Deputy Assistant Secretary, Aviation and International Affairs.
    [FR Doc. 2018-25380 Filed 11-20-18; 8:45 am] BILLING CODE 4910-9X-P
    DEPARTMENT OF THE TREASURY Office of Foreign Assets Control Notice of OFAC Sanctions Actions AGENCY:

    Office of Foreign Assets Control, Treasury.

    ACTION:

    Notice.

    SUMMARY:

    The Department of the Treasury's Office of Foreign Assets Control (OFAC) is publishing the names of one or more persons that have been placed on OFAC's Specially Designated Nationals and Blocked Persons List based on OFAC's determination that one or more applicable legal criteria were satisfied. All property and interests in property subject to U.S. jurisdiction of these persons are blocked, and U.S. persons are generally prohibited from engaging in transactions with them.

    DATES:

    See Supplementary Information section.

    FOR FURTHER INFORMATION CONTACT:

    OFAC: Associate Director for Global Targeting, tel.: 202-622-2420; Assistant Director for Sanctions Compliance & Evaluation, tel.: 202-622-2490; Assistant Director for Licensing, tel.: 202-622-2480; Assistant Director for Regulatory Affairs, tel. 202-622-4855; or the Department of the Treasury's Office of the General Counsel: Office of the Chief Counsel (Foreign Assets Control), tel.: 202-622-2410.

    SUPPLEMENTARY INFORMATION: Electronic Availability

    The Specially Designated Nationals and Blocked Persons List and additional information concerning OFAC sanctions programs are available on OFAC's website (www.treasury.gov/ofac).

    Notice of OFAC Action(s)

    On November 15, 2018, OFAC determined that the property and interests in property subject to U.S. jurisdiction of the following persons are blocked under the relevant sanctions authorities listed below.

    Individuals:

    1. ABAHUSSAIN, Mansour Othman M. (a.k.a. ABAHUSEYIN, Mansur Othman M; a.k.a. HUSSEIN, Mansour Othman Aba); DOB 11 Aug 1972; alt. DOB 10 Aug 1972; POB Majmaa, Saudi Arabia; nationality Saudi Arabia; Gender Male; Passport S059033 (Saudi Arabia) issued 22 Feb 2016 expires 28 Dec 2020 (individual) [GLOMAG].

    Designated pursuant to section 1(a)(ii)(A) of Executive Order 13818 (E.O. 13818) of December 20, 2017, “Blocking the Property of Persons Involved in Serious Human Rights Abuse or Corruption,” for being responsible for or complicit in, or having directly or indirectly engaged in, serious human rights abuse.

    2. ALARIFI, Naif Hassan S. (a.k.a. AL-ARIFI, Nayif Hasan Saad); DOB 28 Feb 1986; POB Riyadh, Saudi Arabia; nationality Saudi Arabia; Gender Male; Passport M644150 (Saudi Arabia) issued 15 Jan 2014 expires 22 Nov 2018 (individual) [GLOMAG].

    Designated pursuant to section 1(a)(ii)(A) of E.O. 13818 for being responsible for or complicit in, or having directly or indirectly engaged in, serious human rights abuse.

    3. ALBALAWI, Fahad Shabib A.; DOB 24 Jan 1985; POB Arar, Saudi Arabia; nationality Saudi Arabia; Gender Male; Passport N163990 (Saudi Arabia) issued 24 May 2015 expires 30 Mar 2020 (individual) [GLOMAG].

    Designated pursuant to section 1(a)(ii)(A) of E.O. 13818 for being responsible for or complicit in, or having directly or indirectly engaged in, serious human rights abuse.

    4. ALBOSTANI, Meshal Saad M. (a.k.a. ALBOST, Meshal Saad M; a.k.a. AL-BOSTANI, Meshal Saad); DOB 27 Mar 1987; nationality Saudi Arabia; Gender Male; Passport R339037 (Saudi Arabia) expires 09 Jun 2020 (individual) [GLOMAG].

    Designated pursuant to section 1(a)(ii)(A) of E.O. 13818 for being responsible for or complicit in, or having directly or indirectly engaged in, serious human rights abuse.

    5. ALHARBI, Thaar Ghaleb T.; DOB 01 Aug 1979; POB Riyadh, Saudi Arabia; nationality Saudi Arabia; Gender Male; Passport P723557 (Saudi Arabia) issued 05 Feb 2015 expires 13 Dec 2019 (individual) [GLOMAG].

    Designated pursuant to section 1(a)(ii)(A) of E.O. 13818 for being responsible for or complicit in, or having directly or indirectly engaged in, serious human rights abuse.

    6. ALHAWSAWI, Abdulaziz Mohammed M.; DOB 20 Jul 1987; POB Riyadh, Saudi Arabia; nationality Saudi Arabia; Gender Male; Passport P051811 (Saudi Arabia) issued 15 May 2014 expires 23 Mar 2019; National ID No. 1044087474 (Saudi Arabia) (individual) [GLOMAG].

    Designated pursuant to section 1(a)(ii)(A) of E.O. 13818 for being responsible for or complicit in, or having directly or indirectly engaged in, serious human rights abuse.

    7. ALMADANI, Mustafa Mohammed M. (a.k.a. AL-MADANI, Mustafa); DOB 08 Dec 1961; POB Riyadh, Saudi Arabia; alt. POB Makkah, Saudi Arabia; nationality Saudi Arabia; Gender Male; Passport P797794 (Saudi Arabia) issued 16 Mar 2015 expires 20 Jan 2020; National ID No. 1011123229 (Saudi Arabia) (individual) [GLOMAG].

    Designated pursuant to section 1(a)(ii)(A) of E.O. 13818 for being responsible for or complicit in, or having directly or indirectly engaged in, serious human rights abuse.

    8. ALOTAIBI, Khalid Aedh G. (a.k.a. ALTAIBI, Khaled Aedh G); DOB 28 Jun 1988; POB Afif, Saudi Arabia; nationality Saudi Arabia; Gender Male; Passport P139681 (Saudi Arabia) issued 27 May 2014 expires 04 Apr 2019; National ID No. 1053629885 (Saudi Arabia) (individual) [GLOMAG].

    Designated pursuant to section 1(a)(ii)(A) of E.O. 13818 for being responsible for or complicit in, or having directly or indirectly engaged in, serious human rights abuse.

    9. ALOTAIBI, Badr Lafi M. (a.k.a. AL OTAIBI, Badr Lafi M.); DOB 06 Jul 1973; POB Riyadh, Saudi Arabia; nationality Saudi Arabia; Gender Male; Passport P667604 (Saudi Arabia) issued 07 Jan 2015 expires 13 Nov 2019 (individual) [GLOMAG].

    Designated pursuant to section 1(a)(ii)(A) of E.O. 13818 for being responsible for or complicit in, or having directly or indirectly engaged in, serious human rights abuse.

    10. AL-OTAIBI, Mohammad (a.k.a. ALOTAIBI, Mohammed I.); DOB 06 Nov 1964; POB Riyadh, Saudi Arabia; nationality Saudi Arabia; Gender Male (individual) [GLOMAG].

    Designated pursuant to section 1(a)(ii)(A) of E.O. 13818 for being responsible for or complicit in, or having directly or indirectly engaged in, serious human rights abuse.

    11. ALQAHTANI, Saif Saad Q.; DOB 1973; nationality Saudi Arabia; Gender Male (individual) [GLOMAG].

    Designated pursuant to section 1(a)(ii)(A) of E.O. 13818 for being responsible for or complicit in, or having directly or indirectly engaged in, serious human rights abuse.

    12. ALSEHRI, Waleed Abdullah M. (a.k.a. ALSHEHRI, Waleed Abdullah M.); DOB 05 Nov 1980; POB Riyadh, Saudi Arabia; nationality Saudi Arabia; Gender Male; Passport R120404 (Saudi Arabia) issued 31 May 2015 expires 06 Apr 2020 (individual) [GLOMAG].

    Designated pursuant to section 1(a)(ii)(A) of E.O. 13818 for being responsible for or complicit in, or having directly or indirectly engaged in, serious human rights abuse.

    13. ALSEHRI, Turki Muserref M. (a.k.a. ALSEHRI, Turki Musharraf M); DOB 1982; nationality Saudi Arabia; Gender Male (individual) [GLOMAG].

    Designated pursuant to section 1(a)(ii)(A) of E.O. 13818 for being responsible for or complicit in, or having directly or indirectly engaged in, serious human rights abuse.

    14. ALZAHRANI, Mohammed Saad H.; DOB 08 Mar 1988; POB Riyadh, Saudi Arabia; nationality Saudi Arabia; Gender Male; Passport T233763 (Saudi Arabia) issued 16 Jun 2016 expires 23 Apr 2021; National ID No. 1060613203 (Saudi Arabia) (individual) [GLOMAG].

    Designated pursuant to section 1(a)(ii)(A) of E.O. 13818 for being responsible for or complicit in, or having directly or indirectly engaged in, serious human rights abuse.

    15. MUTREB, Maher Abdulaziz M.; DOB 23 May 1971; POB Makkah, Saudi Arabia; nationality Saudi Arabia; Gender Male; Passport D088677 (Saudi Arabia) issued 16 Aug 2017 expires 23 Jun 2022 (individual) [GLOMAG].

    Designated pursuant to section 1(a)(ii)(A) of E.O. 13818 for being responsible for or complicit in, or having directly or indirectly engaged in, serious human rights abuse.

    16. AL-QAHTANI, Saud (a.k.a. ALQAHTANI, Saud Abdullah S), Riyadh, Saudi Arabia; DOB 07 Jul 1978; POB Riyadh, Saudi Arabia; nationality Saudi Arabia; Gender Male; Passport D079021 (individual) [GLOMAG].

    Designated pursuant to section 1(a)(ii)(A) of E.O. 13818 for being responsible for or complicit in, or having directly or indirectly engaged in, serious human rights abuse.

    17. TUBAIGY, Salah Muhammed A. (a.k.a. AL-TUBAIQI, Salah); DOB 20 Aug 1971; POB Jazan, Saudi Arabia; nationality Saudi Arabia; Gender Male (individual) [GLOMAG].

    Designated pursuant to section 1(a)(ii)(A) of E.O. 13818 for being responsible for or complicit in, or having directly or indirectly engaged in, serious human rights abuse.

    Dated: November 15, 2018. Andrea Gacki, Director, Office of Foreign Assets Control.
    [FR Doc. 2018-25346 Filed 11-20-18; 8:45 am] BILLING CODE 4810-AL-P
    DEPARTMENT OF VETERANS AFFAIRS Joint Biomedical Laboratory Research and Development and Clinical Science Research and Development Services Scientific Merit Review Board; Notice of Meetings

    The Department of Veterans Affairs (VA) gives notice under Federal Advisory Committee Act that the subcommittees of the Joint Biomedical Laboratory Research and Development and Clinical Science Research and Development Services Scientific Merit Review Board (JBL/CS SMRB) will meet from 8:00 a.m. to 5:00 p.m. on the dates indicated below (unless otherwise listed):

    Subcommittee Date Location Pulmonary Medicine November 14, 2018 20 F Conference Center. Surgery November 14, 2018 20 F Conference Center. Oncology-B November 14, 2018 Phoenix Park Hotel. Infectious Diseases-B November 15, 2018 20 F Conference Center. Oncology-A/D November 15, 2018 20 F Conference Center. Hematology November 16, 2018 20 F Conference Center. Oncology-C November 16, 2018 20 F Conference Center. Cellular & Molecular Medicine November 19, 2018 20 F Conference Center. Nephrology November 27, 2018 20 F Conference Center. Oncology-E November 27, 2018 20 F Conference Center. Immunology & Dermatology-A November 28, 2018 20 F Conference Center. Infectious Diseases-A November 28, 2018 VA Central Office.* Mental Health & Behavioral Sciences-B November 28-29, 2018 20 F Conference Center. Neurobiology-C November 28, 2018 20 F Conference Center. Endocrinology-A November 29, 2018 20 F Conference Center. Neurobiology-E November 30, 2018 20 F Conference Center. Cardiovascular Studies-A December 3, 2018 Phoenix Park Hotel. Endocrinology-B December 3, 2018 20 F Conference Center. Neurobiology-B December 3, 2018 20 F Conference Center. Mental Health & Behavioral Sciences-A December 4, 2018 20 F Conference Center. Special Emphasis Panel on Million Veteran Prog Proj December 4, 2018 VA Central Office.* Neurobiology-F December 5, 2018 VA Central Office.* Cardiovascular Studies-B December 6, 2018 20 F Conference Center. Epidemiology December 6, 2018 Phoenix Park Hotel. Gastroenterology December 6, 2018 20 F Conference Center. Neurobiology-A December 7, 2018 20 F Conference Center. Neurobiology-D December 7, 2018 20 F Conference Center. Gulf War Research December 7, 2018 Phoenix Park Hotel. Special Panel for Sheep Review December 11, 2018 VA Central Office.* Eligibility January 18, 2018 20 F Conference Center. The addresses of the meeting sites are: 20 F Conference Center, 20 F Street NW, Washington, DC; Phoenix Park Hotel, 520 North Capital Street NW, Washington, DC; VA Central Office, 1100 First Street NE, Suite 600, Washington, DC. * Teleconference.

    The purpose of the subcommittees is to provide advice on the scientific quality, budget, safety and mission relevance of investigator-initiated research proposals submitted for VA merit review evaluation. Proposals submitted for review include various medical specialties within the general areas of biomedical, behavioral and clinical science research.

    These subcommittee meetings will be closed to the public for the review, discussion, and evaluation of initial and renewal research proposals, which involve reference to staff and consultant critiques of research proposals. Discussions will deal with scientific merit of each proposal and qualifications of personnel conducting the studies, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. Additionally, premature disclosure of research information could significantly obstruct implementation of proposed agency action regarding the research proposals. As provided by subsection 10(d) of Public Law 92-463, as amended by Public Law 94-409, closing the subcommittee meetings is in accordance with Title 5 U.S.C. 552b(c)(6) and (9)(B).

    Those who would like to obtain a copy of the minutes from the closed subcommittee meetings and rosters of the subcommittee members should contact Holly Krull, Ph.D., Manager, Merit Review Program (10P9B), Department of Veterans Affairs, 810 Vermont Avenue NW, Washington, DC 20420, at (202) 632-8522 or email at [email protected].

    Dated: November 16, 2018. LaTonya L. Small, Federal Advisory Committee Management Officer.
    [FR Doc. 2018-25405 Filed 11-20-18; 8:45 am] BILLING CODE 8320-01-P
    83 225 Wednesday, November 21, 2018 Rules and Regulations Part II Department of Health and Human Services Centers for Medicare & Medicaid Services 42 CFR Parts 416 and 419 Medicare Program: Changes to Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems and Quality Reporting Programs; Rules DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare & Medicaid Services 42 CFR Parts 416 and 419 [CMS-1695-FC] RIN 0938-AT30 Medicare Program: Changes to Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems and Quality Reporting Programs AGENCY:

    Centers for Medicare & Medicaid Services (CMS), HHS.

    ACTION:

    Final rule with comment period.

    SUMMARY:

    This final rule with comment period revises the Medicare hospital outpatient prospective payment system (OPPS) and the Medicare ambulatory surgical center (ASC) payment system for CY 2019 to implement changes arising from our continuing experience with these systems. In this final rule with comment period, we describe the changes to the amounts and factors used to determine the payment rates for Medicare services paid under the OPPS and those paid under the ASC payment system. In addition, this final rule with comment period updates and refines the requirements for the Hospital Outpatient Quality Reporting (OQR) Program and the ASC Quality Reporting (ASCQR) Program. In addition, we are updating the Hospital Consumer Assessment of Healthcare Providers and Systems (HCAHPS) Survey measure under the Hospital Inpatient Quality Reporting (IQR) Program by removing the Communication about Pain questions; and retaining two measures that were proposed for removal, the Catheter-Associated Urinary Tract Infection (CAUTI) Outcome Measure and Central Line-Associated Bloodstream Infection (CLABSI) Outcome Measure, in the PPS-Exempt Cancer Hospital Quality Reporting (PCHQR) Program beginning with the FY 2021 program year.

    DATES:

    Effective date: This final rule with comment period is effective on January 1, 2019.

    Comment period: To be assured consideration, comments on the payment classifications assigned to the interim APC assignments and/or status indicators of new or replacement Level II HCPCS codes in this final rule with comment period must be received at one of the addresses provided in the ADDRESSES section no later than 5 p.m. EST on December 3, 2018.

    ADDRESSES:

    In commenting, please refer to file code CMS-1695-FC when commenting on the issues in this final rule with comment period. Because of staff and resource limitations, we cannot accept comments by facsimile (FAX) transmission.

    Comments, including mass comment submissions, must be submitted in one of the following three ways (please choose only one of the ways listed):

    1. Electronically. You may (and we encourage you to) submit electronic comments on this regulation to http://www.regulations.gov. Follow the instructions under the “submit a comment” tab.

    2. By regular mail. You may mail written comments to the following address ONLY:

    Centers for Medicare & Medicaid Services, Department of Health and Human Services, Attention: CMS-1695-FC, P.O. Box 8013, Baltimore, MD 21244-1850.

    Please allow sufficient time for mailed comments to be received before the close of the comment period.

    3. By express or overnight mail. You may send written comments via express or overnight mail to the following address ONLY:

    Centers for Medicare & Medicaid Services, Department of Health and Human Services, Attention: CMS-1695-FC, Mail Stop C4-26-05, 7500 Security Boulevard, Baltimore, MD 21244-1850.

    b. For delivery in Baltimore, MD—

    Centers for Medicare & Medicaid Services, Department of Health and Human Services, 7500 Security Boulevard, Baltimore, MD 21244-1850.

    For information on viewing public comments, we refer readers to the beginning of the SUPPLEMENTARY INFORMATION section.

    FOR FURTHER INFORMATION CONTACT:

    340B Drug Payment Policy to Nonexcepted Off-Campus Departments of a Hospital, contact Juan Cortes via email [email protected] or at 410-786-4325.

    Advisory Panel on Hospital Outpatient Payment (HOP Panel), contact the HOP Panel mailbox at [email protected].

    Ambulatory Surgical Center (ASC) Payment System, contact Scott Talaga via email [email protected] or at 410-786-4142.

    Ambulatory Surgical Center Quality Reporting (ASCQR) Program Administration, Validation, and Reconsideration Issues, contact Anita Bhatia via email [email protected] or at 410-786-7236.

    Ambulatory Surgical Center Quality Reporting (ASCQR) Program Measures, contact Vinitha Meyyur via email Vinitha.Meyy[email protected] or at 410-786-8819.

    Blood and Blood Products, contact Josh McFeeters via email [email protected] or at 410-786-9732.

    Cancer Hospital Payments, contact Scott Talaga via email [email protected] or at 410-786-4142.

    CMS Web Posting of the OPPS and ASC Payment Files, contact Chuck Braver via email [email protected] or at 410-786-6719.

    CPT Codes, contact Marjorie Baldo via email [email protected] or at 410-786-4617.

    Collecting Data on Services Furnished in Off-Campus Provider-Based Emergency Departments, contact Twi Jackson via email [email protected] or at 410-786-1159.

    Control for Unnecessary Increases in Volume of Outpatient Services, contact Elise Barringer via email [email protected] or at 410-786-9222.

    Composite APCs (Low Dose Brachytherapy and Multiple Imaging), contact Elise Barringer via email [email protected] or at 410-786-9222.

    Comprehensive APCs (C-APCs), contact Lela Strong-Holloway via email [email protected] or at 410-786-3213.

    Expansion of Clinical Families of Services at Excepted Off-Campus Departments of a Provider, contact Juan Cortes via email [email protected] or at 410-786-4325.

    Hospital Outpatient Quality Reporting (OQR) Program Administration, Validation, and Reconsideration Issues, contact Anita Bhatia via email [email protected] or at 410-786-7236.

    Hospital Outpatient Quality Reporting (OQR) Program Measures, contact Vinitha Meyyur via email [email protected] or at 410-786-8819.

    Hospital Outpatient Visits (Emergency Department Visits and Critical Care Visits), contact Twi Jackson via email [email protected] or at 410-786-1159.

    Inpatient Only (IPO) Procedures List, contact Lela Strong-Holloway via email [email protected] or at 410-786-3213.

    New Technology Intraocular Lenses (NTIOLs), contact Scott Talaga via email [email protected] or at 410-786-4142.

    No Cost/Full Credit and Partial Credit Devices, contact Twi Jackson via email [email protected] or at 410-786-1159.

    OPPS Brachytherapy, contact Scott Talaga via email [email protected] or at 410-786-4142.

    OPPS Data (APC Weights, Conversion Factor, Copayments, Cost-to-Charge Ratios (CCRs), Data Claims, Geometric Mean Calculation, Outlier Payments, and Wage Index), contact Erick Chuang via email [email protected] or at 410-786-1816, Steven Johnson via email [email protected] or at 410-786-3332, or Scott Talaga via email [email protected] or at 410-786-4142.

    OPPS Drugs, Radiopharmaceuticals, Biologicals, and Biosimilar Products, contact Josh McFeeters via email [email protected] or at 410-786-9732.

    OPPS New Technology Procedures/Services, contact the New Technology APC email at [email protected].

    OPPS Exceptions to the 2 Times Rule, contact Marjorie Baldo via email [email protected] or at 410-786-4617.

    OPPS Packaged Items/Services, contact Lela Strong-Holloway via email [email protected] or at 410-786-3213.

    OPPS Pass-Through Devices, contact the Device Pass-Through email at [email protected].

    OPPS Status Indicators (SI) and Comment Indicators (CI), contact Marina Kushnirova via email [email protected] or at 410-786-2682.

    Partial Hospitalization Program (PHP) and Community Mental Health Center (CMHC) Issues, contact the PHP Payment Policy Mailbox at [email protected].

    PPS-Exempt Cancer Hospital Quality Reporting (PCHQR) Program measures, contact Nekeshia McInnis via email [email protected].

    Rural Hospital Payments, contact Josh McFeeters via email [email protected] or at 410-786-9732.

    Skin Substitutes, contact Josh McFeeters via email [email protected] or at 410-786-9732.

    All Other Issues Related to Hospital Outpatient and Ambulatory Surgical Center Payments Not Previously Identified, contact Marjorie Baldo via email [email protected] or at 410-786-4617.

    SUPPLEMENTARY INFORMATION:

    Inspection of Public Comments: All comments received before the close of the comment period are available for viewing by the public, including any personally identifiable or confidential business information that is included in a comment. We post all comments received before the close of the comment period on the following website as soon as possible after they have been received: http://www.regulations.gov/. Follow the search instructions on that website to view public comments.

    Electronic Access

    This Federal Register document is also available from the Federal Register online database through Federal Digital System (FDsys), a service of the U.S. Government Publishing Office. This database can be accessed via the internet at https://www.thefederalregister.org/fdsys/.

    Addenda Available Only Through the Internet on the CMS Website

    In the past, a majority of the Addenda referred to in our OPPS/ASC proposed and final rules were published in the Federal Register as part of the annual rulemakings. However, beginning with the CY 2012 OPPS/ASC proposed rule, all of the Addenda no longer appear in the Federal Register as part of the annual OPPS/ASC proposed and final rules to decrease administrative burden and reduce costs associated with publishing lengthy tables. Instead, these Addenda are published and available only on the CMS website. The Addenda relating to the OPPS are available at: https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/HospitalOutpatientPPS/index.html. The Addenda relating to the ASC payment system are available at: https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/HospitalOutpatientPPS/index.html.

    Current Procedural Terminology (CPT) Copyright Notice

    Throughout this final rule with comment period, we use CPT codes and descriptions to refer to a variety of services. We note that CPT codes and descriptions are copyright 2018 American Medical Association. All Rights Reserved. CPT is a registered trademark of the American Medical Association (AMA). Applicable Federal Acquisition Regulations (FAR) and Defense Federal Acquisition Regulations (DFAR) apply.

    Table of Contents I. Summary and Background A. Executive Summary of This Document B. Legislative and Regulatory Authority for the Hospital OPPS C. Excluded OPPS Services and Hospitals D. Prior Rulemaking E. Advisory Panel on Hospital Outpatient Payment (the HOP Panel or the Panel) F. Public Comments Received in Response to the CY 2019 OPPS/ASC Proposed Rule G. Public Comments Received in Response to the CY 2018 OPPS/ASC Final Rule With Comment Period II. Updates Affecting OPPS Payments A. Recalibration of APC Relative Payment Weights B. Conversion Factor Update C. Wage Index Changes D. Statewide Average Default Cost-to-Charge Ratios (CCRs) E. Adjustment for Rural Sole Community Hospitals (SCHs) and Essential Access Community Hospitals (EACHs) Under Section 1833(t)(13)(B) of the Act F. Payment Adjustment for Certain Cancer Hospitals for CY 2019 G. Hospital Outpatient Outlier Payments H. Calculation of an Adjusted Medicare Payment From the National Unadjusted Medicare Payment I. Beneficiary Copayments III. OPPS Ambulatory Payment Classification (APC) Group Policies A. OPPS Treatment of New CPT and Level II HCPCS Codes B. OPPS Changes—Variations Within APCs C. New Technology APCs D. OPPS APC-Specific Policies IV. OPPS Payment for Devices A. Pass-Through Payments for Devices B. Device-Intensive Procedures V. OPPS Payment Changes for Drugs, Biologicals, and Radiopharmaceuticals A. OPPS Transitional Pass-Through Payment for Additional Costs of Drugs, Biologicals, and Radiopharmaceuticals B. OPPS Payment for Drugs, Biologicals, and Radiopharmaceuticals Without Pass-Through Payment Status VI. Estimate of OPPS Transitional Pass-Through Spending for Drugs, Biologicals, Radiopharmaceuticals, and Devices A. Background B. Estimate of Pass-Through Spending VII. OPPS Payment for Hospital Outpatient Visits and Critical Care Services VIII. Payment for Partial Hospitalization Services A. Background B. PHP APC Update for CY 2019 C. Outlier Policy for CMHCs D. Proposed Update to PHP Allowable HCPCS Codes IX. Procedures That Will Be Paid Only as Inpatient Procedures A. Background B. Changes to the Inpatient Only (IPO) List X. Nonrecurring Policy Changes A. Collecting Data on Services Furnished in Off-Campus Provider-Based Emergency Departments B. Method To Control Unnecessary Increases in the Volume of Outpatient Services C. Application of the 340B Drug Payment Policy to Nonexcepted Off-Campus Departments of a Hospital D. Expansion of Clinical Families of Services at Excepted Off-Campus Departments of a Provider XI. CY 2019 OPPS Payment Status and Comment Indicators A. CY 2019 OPPS Payment Status Indicator Definitions B. CY 2019 Comment Indicator Definitions XII. Updates to the Ambulatory Surgical Center (ASC) Payment System A. Background B. Treatment of New and Revised Codes C. Update to the List of ASC Covered Surgical Procedures and Covered Ancillary Services D. ASC Payment for Covered Surgical Procedures and Covered Ancillary Services E. New Technology Intraocular Lenses (NTIOLs) F. ASC Payment and Comment Indicators G. Calculation of the ASC Payment Rates and the ASC Conversion Factor XIII. Requirements for the Hospital Outpatient Quality Reporting (OQR) Program A. Background B. Hospital OQR Program Quality Measures C. Administrative Requirements D. Form, Manner, and Timing of Data Submitted for the Hospital OQR Program E. Payment Reduction for Hospitals That Fail To Meet the Hospital OQR Program Requirements for the CY 2019 Payment Determination XIV. Requirements for the Ambulatory Surgical Center Quality Reporting (ASCQR) Program A. Background B. ASCQR Program Quality Measures C. Administrative Requirements D. Form, Manner, and Timing of Data Submitted for the ASCQR Program E. Payment Reduction for ASCs That Fail To Meet the ASCQR Program Requirements XV. Comments Received in Response to Requests for Information (RFIs) A. Comments Received in Response to Request for Information on Promoting Interoperability and Electronic Health Care Information Exchange Through Possible Revisions to the CMS Patient Health and Safety Requirements for Hospitals and Other Medicare-Participating and Medicaid-Participating Providers and Suppliers B. Comments Received in Response to Request for Information on Price Transparency: Improving Beneficiary Access to Provider and Supplier Charge Information C. Comments Received in Response to Request for Information on Leveraging the Authority for the Competitive Acquisition Program (CAP) for Part B Drugs and Biologicals for a Potential CMS Innovation Center Model XVI. Additional Hospital Inpatient Quality Reporting (IQR) Program Policies XVII. Additional PPS-Exempt Cancer Hospital Quality Reporting (PCHQR) Program Policies A. Background B. Retention and Removal of Previously Finalized Quality Measures for PCHs Beginning With the FY 2021 Program Year C. Public Display Requirements XVIII. Files Available to the Public via the Internet XIX. Collection of Information Requirements A. Statutory Requirement for Solicitation of Comments B. ICRs for the Hospital OQR Program C. ICRs for the ASCQR Program D. ICRs for the Update to the HCAHPS Survey Measure in the Hospital IQR Program E. Total Reduction in Burden Hours and in Costs XX. Response to Comments XXI. Economic Analyses A. Statement of Need B. Overall Impact for the Provisions of This Final Rule With Comment Period C. Detailed Economic Analyses D. Effects of the Update to the HCAHPS Survey Measure in the Hospital IQR Program E. Effects of Requirements for the PPS-Exempt Cancer Hospital Quality Reporting (PCHQR) Program F. Regulatory Review Costs G. Regulatory Flexibility Act (RFA) Analysis H. Unfunded Mandates Reform Act Analysis I. Reducing Regulation and Controlling Regulatory Costs J. Conclusion XXII. Federalism Analysis Regulation Text I. Summary and Background A. Executive Summary of This Document 1. Purpose

    In this final rule with comment period, we are updating the payment policies and payment rates for services furnished to Medicare beneficiaries in hospital outpatient departments (HOPDs) and ambulatory surgical centers (ASCs), beginning January 1, 2019. Section 1833(t) of the Social Security Act (the Act) requires us to annually review and update the payment rates for services payable under the Hospital Outpatient Prospective Payment System (OPPS). Specifically, section 1833(t)(9)(A) of the Act requires the Secretary to review certain components of the OPPS not less often than annually, and to revise the groups, relative payment weights, and the wage and other adjustments that take into account changes in medical practices, changes in technologies, and the addition of new services, new cost data, and other relevant information and factors. In addition, under section 1833(i) of the Act, we annually review and update the ASC payment rates. This final rule with comment period also includes additional policy changes made in accordance with our experience with the OPPS and the ASC payment system. We describe these and various other statutory authorities in the relevant sections of this final rule with comment period. In addition, this final rule with comment period updates and refines the requirements for the Hospital Outpatient Quality Reporting (OQR) Program and the ASC Quality Reporting (ASCQR) Program.

    In this final rule with comment period, two quality reporting policies that impact inpatient hospitals are updated due to their time sensitivity. In the Hospital IQR Program, we are updating the HCAHPS Survey measure by removing the Communication about Pain questions from the HCAHPS Survey, which are used to assess patients' experiences of care, effective with October 2019 discharges for the FY 2021 payment determination and subsequent years. This policy addresses public health concerns about opioid overprescribing through patient pain management questions that were recommended for removal in the President's Commission on Combating Drug Addiction and the Opioid Crisis report. In addition, we are finalizing that we will not publicly report any data collected from the Communication Abut Pain questions—a modification from what we proposed. We also are retaining two measures that we proposed for removal in the PCHQR Program beginning with the FY 2021 program year, the Catheter-Associated Urinary Tract Infection (CAUTI) Outcome Measure and Central Line-Associated Bloodstream Infection (CLABSI) Outcome Measure. This policy impacts infection measurement and public reporting for PPS-exempt cancer hospitals and was deferred to this rule from the CY 2019 IPPS/LTCH PPS final rule published in August 2018.

    2. Improving Patient Outcomes and Reducing Burden Through Meaningful Measures

    Regulatory reform and reducing regulatory burden are high priorities for CMS. To reduce the regulatory burden on the healthcare industry, lower health care costs, and enhance patient care, in October 2017, we launched the Meaningful Measures Initiative.1 This initiative is one component of our agency-wide Patients Over Paperwork Initiative,2 which is aimed at evaluating and streamlining regulations with a goal to reduce unnecessary cost and burden, increase efficiencies, and improve beneficiary experience. The Meaningful Measures Initiative is aimed at identifying the highest priority areas for quality measurement and quality improvement in order to assess the core quality of care issues that are most vital to advancing our work to improve patient outcomes. The Meaningful Measures Initiative represents a new approach to quality measures that fosters operational efficiencies, and will reduce costs including, collection and reporting burden, while producing quality measurement that is more focused on meaningful outcomes.

    1 Meaningful Measures web page: https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/QualityInitiativesGenInfo/MMF/General-info-Sub-Page.html.

    2 Remarks by Administrator Seema Verma at the Health Care Payment Learning and Action Network (LAN) Fall Summit, as prepared for delivery on October 30, 2017. Available at: https://www.cms.gov/Newsroom/MediaReleaseDatabase/Fact-sheets/2017-Fact-Sheet-items/2017-10-30.html.

    The Meaningful Measures framework has the following objectives:

    • Address high-impact measure areas that safeguard public health;

    • Patient-centered and meaningful to patients;

    • Outcome-based where possible;

    • Fulfill each program's statutory requirements;

    • Minimize the level of burden for health care providers;

    • Significant opportunity for improvement;

    • Address measure needs for population based payment through alternative payment models; and

    • Align across programs and/or with other payers.

    In order to achieve these objectives, we have identified 19 Meaningful Measures areas and mapped them to six overarching quality priorities, as shown in the table below.

    BILLING CODE 4120-01-P ER21NO18.000 BILLING CODE 4120-01-C

    By including Meaningful Measures in our programs, we believe that we can also address the following cross-cutting measure criteria:

    • Eliminating disparities;

    • Tracking measurable outcomes and impact;

    • Safeguarding public health;

    • Achieving cost savings;

    • Improving access for rural communities; and

    • Reducing burden.

    We believe that the Meaningful Measures Initiative will improve outcomes for patients, their families, and health care providers while reducing burden and costs for clinicians and providers as well as promoting operational efficiencies.

    We received numerous comments from stakeholders regarding the Meaningful Measures Initiative and the impact of its implementation in CMS' quality programs. Many of these comments pertained to specific program proposals, and are discussed in the appropriate program-specific sections of this final rule with comment period. However, commenters also provided insights and recommendations for the ongoing development of the Meaningful Measures Initiative generally, including: ensuring transparency in public reporting and usability of publicly reported data; evaluating the benefit of individual measures to patients via use in quality programs weighed against the burden to providers of collecting and reporting that measure data; and identifying additional opportunities for alignment across CMS quality programs. We look forward to continuing to work with stakeholders to refine and further implement the Meaningful Measures Initiative, and will take commenters' insights and recommendations into account moving forward.

    3. Summary of the Major Provisions

    OPPS Update: For CY 2019, we are increasing the payment rates under the OPPS by an outpatient department (OPD) fee schedule increase factor of 1.35 percent. This increase factor is based on the final hospital inpatient market basket percentage increase of 2.9 percent for inpatient services paid under the hospital inpatient prospective payment system (IPPS), minus the multifactor productivity (MFP) adjustment of 0.8 percentage point, and minus a 0.75 percentage point adjustment required by the Affordable Care Act. Based on this update, we estimate that total payments to OPPS providers (including beneficiary cost-sharing and estimated changes in enrollment, utilization, and case-mix) for CY 2019 will be approximately $74.1 billion, an increase of approximately $5.8 billion compared to estimated CY 2018 OPPS payments.

    We are continuing to implement the statutory 2.0 percentage point reduction in payments for hospitals failing to meet the hospital outpatient quality reporting requirements, by applying a reporting factor of 0.980 to the OPPS payments and copayments for all applicable services.

    Comprehensive APCs: For CY 2019, we are creating three new comprehensive APCs (C-APCs). These new C-APCs include ears, nose, and throat (ENT) and vascular procedures. This increases the total number of C-APCs to 65.

    Changes to the Inpatient Only List: For CY 2019, we are removing four procedures from the inpatient only list and adding one procedure to the list.

    Method to Control Unnecessary Increases in Volume of Outpatient Services: To the extent that similar services are safely provided in more than one setting, it is not prudent for the OPPS to pay more for such services because that leads to an unnecessary increase in the number of those services provided in the OPPS setting. We believe that capping the OPPS payment at the Physician Fee Schedule (PFS)-equivalent rate is an effective method to control the volume of the unnecessary increases in certain services because the payment differential that is driving the site-of-service decision will be removed. In particular, we believe this method of capping payment will control unnecessary volume increases both in terms of numbers of covered outpatient department services furnished and costs of those services. Therefore, as we proposed, we are using our authority under section 1833(t)(2)(F) of the Act to apply an amount equal to the site-specific PFS payment rate for nonexcepted items and services furnished by a nonexcepted off-campus provider-based department (PBD) of a hospital (the PFS payment rate) for the clinic visit service, as described by HCPCS code G0463, when provided at an off-campus PBD excepted from section 1833(t)(21) of the Act. We will be phasing in the application of the reduction in payment for code G0463 in this setting over 2 years. In CY 2019, the payment reduction will be transitioned by applying 50 percent of the total reduction in payment that would apply if these departments were paid the site-specific PFS rate for the clinic visit service. In other words, these departments will be paid 70 percent of the OPPS rate for the clinic visit service in CY 2019. In CY 2020 and subsequent years, these departments will be paid the site-specific PFS rate for the clinic visit service. That is, these departments will be paid 40 percent of the OPPS rate for the clinic visit in CY 2020 and subsequent years. In addition to this proposal, we solicited public comments on how to expand the application of the Secretary's statutory authority under section 1833(t)(2)(F) of the Act to additional items and services paid under the OPPS that may represent unnecessary increases in OPD utilization. The public comment we received will be considered for future rulemaking.

    • Expansion of Clinical Families of Services at Excepted Off-Campus Provider-Based Departments (PBDs) of a Hospital: For CY 2019, we proposed that if an excepted off-campus PBD furnished items and services from a clinical family of services from which it did not furnish items and services (and subsequently bill for those items and services) during a baseline period, services from the new clinical family of services would not be covered OPD services. Instead, services in the new clinical family of services would be paid under the PFS. While we are not finalizing this proposal at this time, we intend to monitor the expansion of services in excepted off-campus PBDs.

    • Application of 340B Drug Payment Policy to Nonexcepted Off-Campus Provider-Based Departments of a Hospital: For CY 2019, as we proposed, we are paying the average sales price (ASP) minus 22.5 percent under the PFS for separately payable 340B-acquired drugs furnished by nonexcepted, off-campus provider-based departments (PBDs) of a hospital. This is consistent with the payment methodology adopted in CY 2018 for 340B-acquired drugs furnished in hospital departments paid under the OPPS.

    • Payment Policy for Biosimilar Biological Products without Pass-Through Status That Are Acquired under the 340B Program: For CY 2019, we are making payment for nonpass-through biosimilars acquired under the 340B program at ASP minus 22.5 percent of the biosimilar's own ASP rather than ASP minus 22.5 percent of the reference product's ASP.

    • Payment of Drugs, Biologicals, and Radiopharmaceuticals If Average Sales Price (ASP) Data Are Not Available: For CY 2019, we are making payment for separately payable drugs and biologicals that do not have pass-through payment status and are not acquired under the 340B Program at wholesale acquisition cost (WAC)+3 percent instead of WAC+6 percent if ASP data are not available. If WAC data are not available for a drug or biological product, we are continuing our policy to pay for separately payable drugs and biologicals at 95 percent of the average wholesale price (AWP). Drugs and biologicals that are acquired under the 340B Program will continue to be paid at ASP minus 22.5 percent, WAC minus 22.5 percent, or 69.46 percent of AWP, as applicable.

    Device-Intensive Procedure Criteria: For CY 2019, we are modifying the device-intensive criteria to allow procedures that involve single-use devices, regardless of whether or not they remain in the body after the conclusion of the procedure, to qualify as device-intensive procedures. We also are allowing procedures with a device offset percentage of greater than 30 percent to qualify as device-intensive procedures.

    Device Pass-Through Payment Applications: For CY 2019, we evaluated seven applications for device pass-through payments and based on public comments received, we are approving one of these applications for device pass-through payment status.

    New Technology APC Payment for Extremely Low-Volume Procedures: For CY 2019 and future years, we are establishing a different payment methodology for services assigned to New Technology APCs with fewer than 100 claims using our equitable adjustment authority under section 1833(t)(2)(E) of the Act. We will use a “smoothing methodology” based on multiple years of claims data to establish a more stable rate for services assigned to New Technology APCs with fewer than 100 claims per year under the OPPS. Under this policy, we will calculate the geometric mean costs, the median costs, and the arithmetic mean costs for these procedures and adopt through our annual rulemaking the most appropriate payment rate for the service using one of these methodologies. We will use this approach to establish a payment rate for each low-volume service both for purposes of assigning the service to a New Technology APC and to a clinical APC at the conclusion of payment for the service through a New Technology APC. In addition, we are excluding services assigned to New Technology APCs from bundling intoC-APC procedures.

    Cancer Hospital Payment Adjustment: For CY 2019, we are continuing to provide additional payments to cancer hospitals so that the cancer hospital's payment-to-cost ratio (PCR) after the additional payments is equal to the weighted average PCR for the other OPPS hospitals using the most recently submitted or settled cost report data. However, section 16002(b) of the 21st Century Cures Act requires that this weighted average PCR be reduced by 1.0 percentage point. Based on the data and the required 1.0 percentage point reduction, we are providing that a target PCR of 0.88 will be used to determine the CY 2019 cancer hospital payment adjustment to be paid at cost report settlement. That is, the payment adjustments will be the additional payments needed to result in a PCR equal to 0.88 for each cancer hospital.

    Rural Adjustment: For 2019 and subsequent years, we are continuing the 7.1 percent adjustment to OPPS payments for certain rural SCHs, including essential access community hospitals (EACHs). We intend to continue the 7.1 percent adjustment for future years in the absence of data to suggest a different percentage adjustment should apply.

    Ambulatory Surgical Center (ASC) Payment Update: For CYs 2019 through 2023, we are updating the ASC payment system using the hospital market basket update instead of the CPI-U. However, during this 5-year period, we intend to examine whether such adjustment leads to a migration of services from other settings to the ASC setting. Using the hospital market basket methodology, for CY 2019, we are increasing payment rates under the ASC payment system by 2.1 percent for ASCs that meet the quality reporting requirements under the ASCQR Program. This increase is based on a hospital market basket percentage increase of 2.9 percent minus a MFP adjustment required by the Affordable Care Act of 0.8 percentage point.

    Based on this update, we estimate that total payments to ASCs (including beneficiary cost-sharing and estimated changes in enrollment, utilization, and case-mix) for CY 2019 will be approximately $4.85 billion, an increase of approximately $200 million compared to estimated CY 2018 Medicare payments to ASCs. We note that the CY 2019 ASC payment update, under our prior policy, would have been 1.8 percent, based on a projectedCPI-U update of 2.6 percent minus a MFP adjustment required by the Affordable Care Act of 0.8 percentage point. In addition, we will continue to assess the feasibility of collaborating with stakeholders to collect ASC cost data in a minimally burdensome manner for future policy development.

    Changes to the List of ASC Covered Surgical Procedures: For CY 2019, we are revising our definition of “surgery” in the ASC payment system to account for certain “surgery-like” procedures that are assigned codes outside the Current Procedural Terminology (CPT) surgical range. In addition, as we proposed, we are adding 12 cardiac catheterization procedures, and, in response to public comments, an additional 5 related procedures to the ASC covered procedures list. At this time, we are not finalizing our proposal to establish an additional review of recently added procedures to the ASC covered procedures list.

    Payment for Non-Opioid Pain Management Therapy: For CY 2019, in response to the recommendation from the President's Commission on Combating Drug Addiction and the Opioid Crisis, we are changing the packaging policy for certain drugs when administered in the ASC setting and providing separate payment for non-opioid pain management drugs that function as a supply when used in a surgical procedure when the procedure is performed in an ASC.

    Hospital Outpatient Quality Reporting (OQR) Program: For the Hospital OQR Program, we are making changes effective with this final rule with comment period and for the CY 2019, CY 2020, and CY 2021 payment determinations and subsequent years. Effective on the effective date of this final rule with comment period, we are codifying several previously established policies: to retain measures from a previous year's Hospital OQR Program measure set for subsequent years' measure sets at 42 CFR 419.46(h)(1); to use the rulemaking process to remove a measure for circumstances for which we do not believe that continued use of a measure raises specific patient safety concerns at 42 CFR 419.46(h)(3); and to immediately remove measures as a result of patient safety concerns at 42 CFR 419.46(h)(2). Effective on the effective date of this final rule with comment period, we also are updating measure removal Factor 7; adding a new removal Factor 8; and codifying our measure removal policies and factors. We also are providing clarification of our criteria for “topped-out” measures. These changes align the Hospital OQR Program measure removal factors with those used in the ASCQR Program.

    Beginning with CY 2019, we are updating the frequency with which we will release a Hospital OQR Program Specifications Manual, such that it will occur every 12 months—a modification from what we proposed.

    For the CY 2020 payment determination and subsequent years, we are updating the participation status requirements by removing the Notice of Participation (NOP) form; extending the reporting period for the OP-32: Facility Seven-Day Risk-Standardized Hospital Visit Rate after Outpatient Colonoscopy measure to 3 years; and removing the OP-27: Influenza Vaccination Coverage Among Healthcare Personnel measure.

    Beginning with the CY 2021 payment determination and subsequent years, we are removing the following seven measures: OP-5: Median Time to ECG; OP-9: Mammography Follow-up Rates; OP-11: Thorax CT Use of Contrast Material; OP-12: The Ability for Providers with HIT to Receive Laboratory Data Electronically Directly into Their Qualified/Certified EHR System as Discrete Searchable Data; OP-14: Simultaneous Use of Brain Computed Tomography (CT) and Sinus CT; OP-17: Tracking Clinical Results between Visits; and OP-30: Endoscopy/Polyp Surveillance: Colonoscopy Interval for Patients with a History of Adenomatous Polyps—Avoidance of Inappropriate Use. We are not finalizing our proposals to remove the OP-29 or OP-31 measures.

    Ambulatory Surgical Center Quality Reporting (ASCQR) Program: For the ASCQR Program, we are making changes in policies effective with this final rule with comment period and for the CY 2019, CY 2020, and CY 2021 payment determinations and subsequent years. Effective on the effective date of this final rule with comment period, we are removing one measure removal factor; adding two new measure removal factors; and updating the regulations to better reflect our measure removal policies. We also are making one clarification to measure removal Factor 1. These changes align the ASCQR Program measure removal factors with those used in the Hospital OQR Program.

    Beginning with the CY 2020 payment determination and subsequent years, we are extending the reporting period for the ASC-12: Facility Seven-Day Risk-Standardized Hospital Visit Rate after Outpatient Colonoscopy measure to 3 years; and removing the ASC-8: Influenza Vaccination Coverage Among Healthcare Personnel measure.

    Beginning with the CY 2021 payment determination and subsequent years, we are removing the ASC-10: Endoscopy/Polyp Surveillance: Colonoscopy Interval for Patients with a History of Adenomatous Polyps—Avoidance of Inappropriate Use measure. We are not finalizing our proposals to remove the following measures: ASC-9: Endoscopy/Polyp Surveillance Follow-up Interval for Normal Colonoscopy in Average Risk Patients and ASC-11: Cataracts—Improvement in Patient's Visual Function within 90 Days Following Cataract Surgery. We also are not finalizing our proposals to remove the following measures: ASC-1: Patient Burn; ASC-2: Patient Fall; ASC-3: Wrong Site, Wrong Side, Wrong Patient, Wrong Procedure, Wrong Implant; and ASC-4: All-Cause Hospital Transfer/Admission, but are retaining these measures in the ASCQR Program and suspending data collection for them until further action in rulemaking with the goal of revising the measures.

    Hospital Inpatient Quality Reporting (IQR) Program Update: In this final rule with comment period, we are finalizing a modification of our proposals to update the HCAHPS Survey measure by finalizing the removal of the Communication About Pain questions from the HCAHPS Survey for the Hospital IQR Program, effective with October 2019 discharges for the FY 2021 payment determination and subsequent years. In addition, instead of publicly reporting the data from October 2020 until October 2022 and then subsequently discontinuing reporting as proposed, we are finalizing that we will not publicly report any data collected from the Communication About Pain questions.

    4. Summary of Costs and Benefits

    In sections XXI. and XXII. of this CY 2019 OPPS/ASC final rule with comment period, we set forth a detailed analysis of the regulatory and Federalism impacts that the changes will have on affected entities and beneficiaries. Key estimated impacts are described below.

    a. Impacts of All OPPS Changes

    Table 62 in section XXI. of this final rule with comment period displays the distributional impact of all the OPPS changes on various groups of hospitals and CMHCs for CY 2019 compared to all estimated OPPS payments in CY 2018. We estimate that the policies in this final rule with comment period will result in a 0.6 percent overall increase in OPPS payments to providers. We estimate that total OPPS payments for CY 2019, including beneficiary cost-sharing, to the approximately 3,840 facilities paid under the OPPS (including general acute care hospitals, children's hospitals, cancer hospitals, and CMHCs) will increase by approximately $360 million compared to CY 2018 payments, excluding our estimated changes in enrollment, utilization, and case-mix.

    We estimated the isolated impact of our OPPS policies on CMHCs because CMHCs are only paid for partial hospitalization services under the OPPS. Continuing the provider-specific structure we adopted beginning in CY 2011, and basing payment fully on the type of provider furnishing the service, we estimate a 15.1 percent decrease in CY 2019 payments to CMHCs relative to their CY 2018 payments.

    b. Impacts of the Updated Wage Indexes

    We estimate that our update of the wage indexes based on the FY 2019 IPPS final rule wage indexes will result in no estimated payment change for urban hospitals under the OPPS and an estimated decrease of 0.2 percent for rural hospitals. These wage indexes include the continued implementation of the OMB labor market area delineations based on 2010 Decennial Census data, with updates, as discussed in section II.C. of this final rule with comment period.

    c. Impacts of the Rural Adjustment and the Cancer Hospital Payment Adjustment

    There are no significant impacts of our CY 2019 payment policies for hospitals that are eligible for the rural adjustment or for the cancer hospital payment adjustment. We are not making any change in policies for determining the rural hospital payment adjustments. While we are implementing the required reduction to the cancer hospital payment adjustment required by section 16002 of the 21st Century Cures Act for CY 2019, the target payment-to-cost ratio (PCR) for CY 2019 remains the same as in CY 2018 and therefore does not impact the budget neutrality adjustments.

    d. Impacts of the OPD Fee Schedule Increase Factor

    For the CY 2019 OPPS/ASC, we are establishing an OPD fee schedule increase factor of 1.35 percent and applying that increase factor to the conversion factor for CY 2019. As a result of the OPD fee schedule increase factor and other budget neutrality adjustments, we estimate that rural and urban hospitals will experience an increase of approximately 1.4 percent for urban hospitals and 1.3 percent for rural hospitals. Classifying hospitals by teaching status, we estimate nonteaching hospitals will experience an increase of 1.4 percent, minor teaching hospitals will experience an increase of 1.3 percent, and major teaching hospitals will experience an increase of 1.5 percent. We also classified hospitals by the type of ownership. We estimate that hospitals with voluntary ownership, hospitals with proprietary ownership, and hospitals with government ownership will all experience an increase of 1.4 percent in payments.

    e. Impacts of the Policy To Control for Unnecessary Increases in the Volume of Outpatient Services

    In section X.B. of this CY 2019 OPPS/ASC final rule with comment period, we discuss our CY 2019 proposal and finalized policies to control for unnecessary increases in the volume of outpatient service by paying for clinic visits furnished at an off-campus PBD of a hospital at a PFS-equivalent rate under the OPPS rather than at the standard OPPS rate. As a result of this finalized policy, we estimated decreases of 0.6 percent to urban hospitals, and estimated decreases of 0.6 percent to rural hospitals, with the estimated effect for individual groups of hospitals depending on the volume of clinic visits provided at the hospitals' off-campus PBDs.

    f. Impacts of the ASC Payment Update

    For impact purposes, the surgical procedures on the ASC list of covered procedures are aggregated into surgical specialty groups using CPT and HCPCS code range definitions. The percentage change in estimated total payments by specialty groups under the CY 2019 payment rates, compared to estimated CY 2018 payment rates, generally ranges between an increase of 1 and 3 percent, depending on the service, with some exceptions. We estimate the impact of applying the hospital market basket update to ASC payment rates will increase payments by $80 million under the ASC payment system in CY 2019, compared to an increase of $60 million if we had applied an update based on CPI-U.

    c. Impact of the Changes to the Hospital OQR Program

    Across 3,300 hospitals participating in the Hospital OQR Program, we estimate that our requirements will result in the following changes to costs and burdens related to information collection for the Hospital OQR Program compared to previously adopted requirements: (1) No change in the total collection of information burden or costs for the CY 2020 payment determination; (2) a total collection of information burden reduction of 681,735 hours and a total collection of information cost reduction of approximately $24.9 million for the CY 2021 payment determination due to the removal of four measures: OP-5, OP-12, OP-17, and OP-30.

    Further, we anticipate that the removal of a total of eight measures will result in a reduction in costs unrelated to information collection. For example, it may be costly for health care providers to track the confidential feedback, preview reports, and publicly reported information on a measure where we use the measure in more than one program. Also, when measures are in multiple programs, maintaining the specifications for those measures, as well as the tools we need to collect, validate, analyze, and publicly report the measure data may result in costs to CMS. In addition, beneficiaries may find it confusing to see public reporting on the same measure in different programs.

    d. Impact of the Changes to the ASCQR Program

    Across 3,937 ASCs participating in the ASCQR Program, we estimate that our requirements will result in the following changes to costs and burdens related to information collection for the ASCQR Program, compared to previously adopted requirements: (1) No change in the total collection of information burden or costs for the CY 2020 payment determination; (2) a total collection of information burden reduction of 62,008 hours and a total collection of information cost reduction of approximately $2,268,244 for the CY 2021 payment determination due to the removal of ASC-10.

    Further, we anticipate that the removal of ASC-10 will result in a reduction in costs unrelated to information collection. For example, it may be costly for health care providers to track the confidential feedback, preview reports, and publicly reported information on a measure where we use the measure in more than one program. Also, when measures are in multiple programs, maintaining the specifications for those measures as well as the tools we need to collect, analyze, and publicly report the measure data may result in costs to CMS. In addition, beneficiaries may find it confusing to see public reporting on the same measure in different programs.

    B. Legislative and Regulatory Authority for the Hospital OPPS

    When Title XVIII of the Social Security Act was enacted, Medicare payment for hospital outpatient services was based on hospital-specific costs. In an effort to ensure that Medicare and its beneficiaries pay appropriately for services and to encourage more efficient delivery of care, the Congress mandated replacement of the reasonable cost-based payment methodology with a prospective payment system (PPS). The Balanced Budget Act of 1997 (BBA) (Pub. L. 105-33) added section 1833(t) to the Act, authorizing implementation of a PPS for hospital outpatient services. The OPPS was first implemented for services furnished on or after August 1, 2000. Implementing regulations for the OPPS are located at 42 CFR parts 410 and 419.

    The Medicare, Medicaid, and SCHIP Balanced Budget Refinement Act of 1999 (BBRA) (Pub. L. 106-113) made major changes in the hospital OPPS. The following Acts made additional changes to the OPPS: the Medicare, Medicaid, and SCHIP Benefits Improvement and Protection Act of 2000 (BIPA) (Pub. L. 106-554); the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA) (Pub. L. 108-173); the Deficit Reduction Act of 2005 (DRA) (Pub. L. 109-171), enacted on February 8, 2006; the Medicare Improvements and Extension Act under Division B of Title I of the Tax Relief and Health Care Act of 2006 (MIEA-TRHCA) (Pub. L. 109-432), enacted on December 20, 2006; the Medicare, Medicaid, and SCHIP Extension Act of 2007 (MMSEA) (Pub. L. 110-173), enacted on December 29, 2007; the Medicare Improvements for Patients and Providers Act of 2008 (MIPPA) (Pub. L. 110-275), enacted on July 15, 2008; the Patient Protection and Affordable Care Act (Pub. L. 111-148), enacted on March 23, 2010, as amended by the Health Care and Education Reconciliation Act of 2010 (Pub. L. 111-152), enacted on March 30, 2010 (these two public laws are collectively known as the Affordable Care Act); the Medicare and Medicaid Extenders Act of 2010 (MMEA, Pub. L. 111-309); the Temporary Payroll Tax Cut Continuation Act of 2011 (TPTCCA, Pub. L. 112-78), enacted on December 23, 2011; the Middle Class Tax Relief and Job Creation Act of 2012 (MCTRJCA, Pub. L. 112-96), enacted on February 22, 2012; the American Taxpayer Relief Act of 2012 (Pub. L. 112-240), enacted January 2, 2013; the Pathway for SGR Reform Act of 2013 (Pub. L. 113-67) enacted on December 26, 2013; the Protecting Access to Medicare Act of 2014 (PAMA, Pub. L. 113-93), enacted on March 27, 2014; the Medicare Access and CHIP Reauthorization Act (MACRA) of 2015 (Pub. L. 114-10), enacted April 16, 2015; the Bipartisan Budget Act of 2015 (Pub. L. 114-74), enacted November 2, 2015; the Consolidated Appropriations Act, 2016 (Pub. L. 114-113), enacted on December 18, 2015, the 21st Century Cures Act (Pub. L. 114-255), enacted on December 13, 2016, the Consolidated Appropriations Act, 2018 (Pub. L. 115-141), enacted on March 23, 2018, and the Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act (Pub. L. 115-271), enacted on October 24, 2018.

    Under the OPPS, we generally pay for hospital Part B services on a rate-per-service basis that varies according to the APC group to which the service is assigned. We use the Healthcare Common Procedure Coding System (HCPCS) (which includes certain Current Procedural Terminology (CPT) codes) to identify and group the services within each APC. The OPPS includes payment for most hospital outpatient services, except those identified in section I.C. of this final rule with comment period. Section 1833(t)(1)(B) of the Act provides for payment under the OPPS for hospital outpatient services designated by the Secretary (which includes partial hospitalization services furnished by CMHCs), and certain inpatient hospital services that are paid under Medicare Part B.

    The OPPS rate is an unadjusted national payment amount that includes the Medicare payment and the beneficiary copayment. This rate is divided into a labor-related amount and a nonlabor-related amount. The labor-related amount is adjusted for area wage differences using the hospital inpatient wage index value for the locality in which the hospital or CMHC is located.

    All services and items within an APC group are comparable clinically and with respect to resource use (section 1833(t)(2)(B) of the Act). In accordance with section 1833(t)(2)(B) of the Act, subject to certain exceptions, items and services within an APC group cannot be considered comparable with respect to the use of resources if the highest median cost (or mean cost, if elected by the Secretary) for an item or service in the APC group is more than 2 times greater than the lowest median cost (or mean cost, if elected by the Secretary) for an item or service within the same APC group (referred to as the “2 times rule”). In implementing this provision, we generally use the cost of the item or service assigned to an APC group.

    For new technology items and services, special payments under the OPPS may be made in one of two ways. Section 1833(t)(6) of the Act provides for temporary additional payments, which we refer to as “transitional pass-through payments,” for at least 2 but not more than 3 years for certain drugs, biological agents, brachytherapy devices used for the treatment of cancer, and categories of other medical devices. For new technology services that are not eligible for transitional pass-through payments, and for which we lack sufficient clinical information and cost data to appropriately assign them to a clinical APC group, we have established special APC groups based on costs, which we refer to as New Technology APCs. These New Technology APCs are designated by cost bands which allow us to provide appropriate and consistent payment for designated new procedures that are not yet reflected in our claims data. Similar to pass-through payments, an assignment to a New Technology APC is temporary; that is, we retain a service within a New Technology APC until we acquire sufficient data to assign it to a clinically appropriate APC group.

    C. Excluded OPPS Services and Hospitals

    Section 1833(t)(1)(B)(i) of the Act authorizes the Secretary to designate the hospital outpatient services that are paid under the OPPS. While most hospital outpatient services are payable under the OPPS, section 1833(t)(1)(B)(iv) of the Act excludes payment for ambulance, physical and occupational therapy, and speech-language pathology services, for which payment is made under a fee schedule. It also excludes screening mammography, diagnostic mammography, and effective January 1, 2011, an annual wellness visit providing personalized prevention plan services. The Secretary exercises the authority granted under the statute to also exclude from the OPPS certain services that are paid under fee schedules or other payment systems. Such excluded services include, for example, the professional services of physicians and nonphysician practitioners paid under the Medicare Physician Fee Schedule (MPFS); certain laboratory services paid under the Clinical Laboratory Fee Schedule (CLFS); services for beneficiaries with end-stage renal disease (ESRD) that are paid under the ESRD prospective payment system; and services and procedures that require an inpatient stay that are paid under the hospital IPPS. In addition, section 1833(t)(1)(B)(v) of the Act does not include applicable items and services (as defined in subparagraph (A) of paragraph (21)) that are furnished on or after January 1, 2017 by an off-campus outpatient department of a provider (as defined in subparagraph (B) of paragraph (21). We set forth the services that are excluded from payment under the OPPS in regulations at 42 CFR 419.22.

    Under § 419.20(b) of the regulations, we specify the types of hospitals that are excluded from payment under the OPPS. These excluded hospitals include:

    • Critical access hospitals (CAHs);

    • Hospitals located in Maryland and paid under the Maryland All-Payer Model;

    • Hospitals located outside of the 50 States, the District of Columbia, and Puerto Rico; and

    • Indian Health Service (IHS) hospitals.

    D. Prior Rulemaking

    On April 7, 2000, we published in the Federal Register a final rule with comment period (65 FR 18434) to implement a prospective payment system for hospital outpatient services. The hospital OPPS was first implemented for services furnished on or after August 1, 2000. Section 1833(t)(9)(A) of the Act requires the Secretary to review certain components of the OPPS, not less often than annually, and to revise the groups, relative payment weights, and the wage and other adjustments that take into account changes in medical practices, changes in technologies, and the addition of new services, new cost data, and other relevant information and factors.

    Since initially implementing the OPPS, we have published final rules in the Federal Register annually to implement statutory requirements and changes arising from our continuing experience with this system. These rules can be viewed on the CMS website at: https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/HospitalOutpatientPPS/Hospital-Outpatient-Regulations-and-Notices.html.

    E. Advisory Panel on Hospital Outpatient Payment (the HOP Panel or the Panel) 1. Authority of the Panel

    Section 1833(t)(9)(A) of the Act, as amended by section 201(h) of Pub. L. 106-113, and redesignated by section 202(a)(2) of Pub. L. 106-113, requires that we consult with an external advisory panel of experts to annually review the clinical integrity of the payment groups and their weights under the OPPS. In CY 2000, based on section 1833(t)(9)(A) of the Act, the Secretary established the Advisory Panel on Ambulatory Payment Classification Groups (APC Panel) to fulfill this requirement. In CY 2011, based on section 222 of the Public Health Service Act, which gives discretionary authority to the Secretary to convene advisory councils and committees, the Secretary expanded the panel's scope to include the supervision of hospital outpatient therapeutic services in addition to the APC groups and weights. To reflect this new role of the panel, the Secretary changed the panel's name to the Advisory Panel on Hospital Outpatient Payment (the HOP Panel or the Panel). The HOP Panel is not restricted to using data compiled by CMS, and in conducting its review, it may use data collected or developed by organizations outside the Department.

    2. Establishment of the Panel

    On November 21, 2000, the Secretary signed the initial charter establishing the Panel, and, at that time, named the APC Panel. This expert panel is composed of appropriate representatives of providers (currently employed full-time, not as consultants, in their respective areas of expertise) who review clinical data and advise CMS about the clinical integrity of the APC groups and their payment weights. Since CY 2012, the Panel also is charged with advising the Secretary on the appropriate level of supervision for individual hospital outpatient therapeutic services. The Panel is technical in nature, and it is governed by the provisions of the Federal Advisory Committee Act (FACA). The current charter specifies, among other requirements, that the Panel—

    • May advise on the clinical integrity of Ambulatory Payment Classification (APC) groups and their associated weights;

    • May advise on the appropriate supervision level for hospital outpatient services;

    • Continues to be technical in nature;

    • Is governed by the provisions of the FACA;

    • Has a Designated Federal Official (DFO); and

    • Is chaired by a Federal Official designated by the Secretary.

    The Panel's charter was amended on November 15, 2011, renaming the Panel and expanding the Panel's authority to include supervision of hospital outpatient therapeutic services and to add critical access hospital (CAH) representation to its membership. The Panel's charter was also amended on November 6, 2014 (80 FR 23009), and the number of members was revised from up to 19 to up to 15 members. The Panel's current charter was approved on November 21, 2016, for a 2-year period (81 FR 94378).

    The current Panel membership and other information pertaining to the Panel, including its charter, Federal Register notices, membership, meeting dates, agenda topics, and meeting reports, can be viewed on the CMS website at: https://www.cms.gov/Regulations-and-Guidance/Guidance/FACA/AdvisoryPanelonAmbulatoryPaymentClassificationGroups.html.

    3. Panel Meetings and Organizational Structure

    The Panel has held many meetings, with the last meeting taking place on August 20, 2018. Prior to each meeting, we publish a notice in the Federal Register to announce the meeting and, when necessary, to solicit nominations for Panel membership, to announce new members and to announce any other changes of which the public should be aware. Beginning in CY 2017, we have transitioned to one meeting per year (81 FR 31941). Further information on the 2018 summer meeting can be found in the meeting notice titled “Medicare Program: Announcement of the Advisory Panel on Hospital Outpatient Payment (the Panel) Meeting on August 20-21, 2018” (83 FR 19785).

    In addition, the Panel has established an operational structure that, in part, currently includes the use of three subcommittees to facilitate its required review process. The three current subcommittees include the following:

    • APC Groups and Status Indicator Assignments Subcommittee, which advises the Panel on the appropriate status indicators to be assigned to HCPCS codes, including but not limited to whether a HCPCS code or a category of codes should be packaged or separately paid, as well as the appropriate APC assignment of HCPCS codes regarding services for which separate payment is made;

    • Data Subcommittee, which is responsible for studying the data issues confronting the Panel and for recommending options for resolving them; and

    • Visits and Observation Subcommittee, which reviews and makes recommendations to the Panel on all technical issues pertaining to observation services and hospital outpatient visits paid under the OPPS.

    Each of these subcommittees was established by a majority vote from the full Panel during a scheduled Panel meeting, and the Panel recommended at the August 20, 2018 meeting that the subcommittees continue. We accepted this recommendation.

    Discussions of the other recommendations made by the Panel at the August 20, 2018 Panel meeting, namely CPT codes and a comprehensive APC for autologous hematopoietic stem cell transplantation, OPPS payment for outpatient clinic visits and restrictions to service line expansions, and packaging policies, were discussed in the CY 2019 OPPS/ASC proposed rule (83 FR 37138 through 37143) or are included in the sections of this final rule with comment period that are specific to each recommendation. For discussions of earlier Panel meetings and recommendations, we refer readers to previously published OPPS/ASC proposed and final rules, the CMS website mentioned earlier in this section, and the FACA database at http://facadatabase.gov.

    F. Public Comments Received in Response to the CY 2019 OPPS/ASC Proposed Rule

    We received over 2,990 timely pieces of correspondence on the CY 2019 OPPS/ASC proposed rule that appeared in the Federal Register on July 31, 2018 (83 FR 37046). We note that we received some public comments that were outside the scope of the CY 2019 OPPS/ASC proposed rule. Out-of-scope public comments are not addressed in this CY 2019 OPPS/ASC final rule with comment period. Summaries of those public comments that are within the scope of the proposed rule and our responses are set forth in the various sections of this final rule with comment period under the appropriate headings.

    G. Public Comments Received on the CY 2018 OPPS/ASC Final Rule With Comment Period

    We received over 125 timely pieces of correspondence on the CY 2018 OPPS/ASC final rule with comment period that appeared in the Federal Register on December 14, 2017 (82 FR 59216), some of which contained comments on the interim APC assignments and/or status indicators of new or replacement Level II HCPCS codes (identified with comment indicator “NI” in OPPS Addendum B, ASC Addendum AA, and ASC Addendum BB to that final rule). Summaries of the public comments are set forth in the CY 2019 proposed rule and this final rule with comment period under the appropriate subject matter headings.

    II. Updates Affecting OPPS Payments A. Recalibration of APC Relative Payment Weights 1. Database Construction a. Database Source and Methodology

    Section 1833(t)(9)(A) of the Act requires that the Secretary review not less often than annually and revise the relative payment weights for APCs. In the April 7, 2000 OPPS final rule with comment period (65 FR 18482), we explained in detail how we calculated the relative payment weights that were implemented on August 1, 2000 for each APC group.

    In the CY 2019 OPPS/ASC proposed rule (83 FR 37055), for CY 2019, we proposed to recalibrate the APC relative payment weights for services furnished on or after January 1, 2019, and before January 1, 2020 (CY 2019), using the same basic methodology that we described in the CY 2018 OPPS/ASC final rule with comment period (82 FR 52367 through 52370), using updated CY 2017 claims data. That is, as we proposed, we recalibrate the relative payment weights for each APC based on claims and cost report data for hospital outpatient department (HOPD) services, using the most recent available data to construct a database for calculating APC group weights.

    For the purpose of recalibrating the APC relative payment weights for CY 2019, we began with approximately 163 million final action claims (claims for which all disputes and adjustments have been resolved and payment has been made) for HOPD services furnished on or after January 1, 2017, and before January 1, 2018, before applying our exclusionary criteria and other methodological adjustments. After the application of those data processing changes, we used approximately 86 million final action claims to develop the proposed CY 2019 OPPS payment weights. For exact numbers of claims used and additional details on the claims accounting process, we refer readers to the claims accounting narrative under supporting documentation for the CY 2019 OPPS/ASC proposed rule on the CMS website at: http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/Hospital>OutpatientPPS/index.html.

    Addendum N to the proposed rule (which is available via the internet on the CMS website) included the proposed list of bypass codes for CY 2019. The proposed list of bypass codes contained codes that were reported on claims for services in CY 2017 and, therefore, included codes that were in effect in CY 2017 and used for billing, but were deleted for CY 2018. We retained these deleted bypass codes on the proposed CY 2019 bypass list because these codes existed in CY 2017 and were covered OPD services in that period, and CY 2017 claims data were used to calculate CY 2019 payment rates. Keeping these deleted bypass codes on the bypass list potentially allows us to create more “pseudo” single procedure claims for ratesetting purposes. “Overlap bypass codes” that are members of the proposed multiple imaging composite APCs were identified by asterisks (*) in the third column of Addendum N to the proposed rule. HCPCS codes that we proposed to add for CY 2019 were identified by asterisks (*) in the fourth column of Addendum N.

    In the CY 2019 OPPS/ASC proposed rule, we did not propose to remove any codes from the CY 2019 bypass list.

    We did not receive any public comments on our general proposal to recalibrate the relative payment weights for each APC based on claims and cost report data for HOPD services or on our proposed bypass code process. Therefore, we are adopting as final the proposed “pseudo” single claims process and the final CY 2019 bypass list of 169 HCPCS codes, as displayed in Addendum N to this final rule with comment period (which is available via the internet on the CMS website). For this final rule with comment period, for purposes of recalibrating the final APC relative payment weights for CY 2019, we used approximately 91 million final action claims (claims for which all disputes and adjustments have been resolved and payment has been made) for HOPD services furnished on or after January 1, 2017 and before January 1, 2018. For exact numbers of claims used and additional details on the claims accounting process, we refer readers to the claims accounting narrative under supporting documentation for this CY 2019 OPPS/ASC final rule with comment period on the CMS website at: http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/HospitalOutpatientPPS/index.html.

    b. Calculation and Use of Cost-to-Charge Ratios (CCRs)

    For CY 2019, in the CY 2019 OPPS/ASC proposed rule (83 FR 37055), we proposed to continue to use the hospital-specific overall ancillary and departmental cost-to-charge ratios (CCRs) to convert charges to estimated costs through application of a revenue code-to-cost center crosswalk. To calculate the APC costs on which the CY 2019 APC payment rates are based, we calculated hospital-specific overall ancillary CCRs and hospital-specific departmental CCRs for each hospital for which we had CY 2017 claims data by comparing these claims data to the most recently available hospital cost reports, which, in most cases, are from CY 2016. For the proposed CY 2019 OPPS payment rates, we used the set of claims processed during CY 2017. We applied the hospital-specific CCR to the hospital's charges at the most detailed level possible, based on a revenue code-to-cost center crosswalk that contains a hierarchy of CCRs used to estimate costs from charges for each revenue code. That crosswalk is available for review and continuous comment on the CMS website at: http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/HospitalOutpatientPPS/index.html.

    To ensure the completeness of the revenue code-to-cost center crosswalk, we reviewed changes to the list of revenue codes for CY 2017 (the year of claims data we used to calculate the proposed CY 2019 OPPS payment rates) and found that the National Uniform Billing Committee (NUBC) did not add any new revenue codes to the NUBC 2017 Data Specifications Manual.

    In accordance with our longstanding policy, we calculate CCRs for the standard and nonstandard cost centers accepted by the electronic cost report database. In general, the most detailed level at which we calculate CCRs is the hospital-specific departmental level. For a discussion of the hospital-specific overall ancillary CCR calculation, we refer readers to the CY 2007 OPPS/ASC final rule with comment period (71 FR 67983 through 67985). The calculation of blood costs is a longstanding exception (since the CY 2005 OPPS) to this general methodology for calculation of CCRs used for converting charges to costs on each claim. This exception is discussed in detail in the CY 2007 OPPS/ASC final rule with comment period and discussed further in section II.A.2.a.(1) of the proposed rule and this final rule with comment period.

    In the CY 2014 OPPS/ASC final rule with comment period (78 FR 74840 through 74847), we finalized our policy of creating new cost centers and distinct CCRs for implantable devices, magnetic resonance imaging (MRIs), computed tomography (CT) scans, and cardiac catheterization. However, in response to the CY 2014 OPPS/ASC proposed rule, commenters reported that some hospitals currently use an imprecise “square feet” allocation methodology for the costs of large moveable equipment like CT scan and MRI machines. They indicated that while CMS recommended using two alternative allocation methods, “direct assignment” or “dollar value,” as a more accurate methodology for directly assigning equipment costs, industry analysis suggested that approximately only half of the reported cost centers for CT scans and MRIs rely on these preferred methodologies. In response to concerns from commenters, we finalized a policy for the CY 2014 OPPS to remove claims from providers that use a cost allocation method of “square feet” to calculate CCRs used to estimate costs associated with the APCs for CT and MRI (78 FR 74847). Further, we finalized a transitional policy to estimate the imaging APC relative payment weights using only CT and MRI cost data from providers that do not use “square feet” as the cost allocation statistic. We provided that this finalized policy would sunset in 4 years to provide a sufficient time for hospitals to transition to a more accurate cost allocation method and for the related data to be available for ratesetting purposes (78 FR 74847). Therefore, beginning CY 2018, with the sunset of the transition policy, we would estimate the imaging APC relative payment weights using cost data from all providers, regardless of the cost allocation statistic employed. However, in the CY 2018 OPPS/ASC final rule with comment period (82 FR 59228 and 59229), we finalized a policy to extend the transition policy for 1 additional year and continued to remove claims from providers that use a cost allocation method of “square feet” to calculate CT and MRI CCRs for the CY 2018 OPPS.

    As we discussed in the CY 2018 OPPS/ASC final rule with comment period (82 FR 59228), some stakeholders have raised concerns regarding using claims from all providers to calculate CT and MRI CCRs, regardless of the cost allocations statistic employed (78 FR 74840 through 74847). Stakeholders noted that providers continue to use the “square feet” cost allocation method and that including claims from such providers would cause significant reductions in the imaging APC payment rates.

    Table 1 below demonstrates the relative effect on imaging APC payments after removing cost data for providers that report CT and MRI standard cost centers using “square feet” as the cost allocation method by extracting HCRIS data on Worksheet B-1. Table 2 below provides statistical values based on the CT and MRI standard cost center CCRs using the different cost allocation methods.

    BILLING CODE 4120-01-P ER21NO18.001

    ER21NO18.002

    Our analysis shows that since the CY 2014 OPPS in which we established the transition policy, the number of valid MRI CCRs has increased by 17.5 percent to 2,177 providers and the number of valid CT CCRs has increased by 15.1 percent to 2,251 providers. However, as shown in Table 1 above, nearly all imaging APCs would see an increase in payment rates for CY 2019 if claims from providers that report using the “square feet” cost allocation method were removed. This can be attributed to the generally lower CCR values from providers that use a cost allocation method of “square feet” as shown in Table 2 above.

    In response to provider concerns and to provide added flexibility for hospitals to improve their cost allocation methods, for the CY 2019 OPPS, in the CY 2019 OPPS/ASC proposed rule (83 FR 37056), we proposed to extend our transition policy and remove claims from providers that use a cost allocation method of “square feet” to calculate CCRs used to estimate costs with the APCs for CT and MRI identified in Table 2 above. We stated in the proposed rule that this proposed extension would mean that CMS would now be providing 6 years for providers to transition from a “square feet” cost allocation method to another cost allocation method. We stated in the proposed rule that we do not believe another extension in CY 2020 will be warranted and expect to determine the imaging APC relative payment weights for CY 2020 using cost data from all providers, regardless of the cost allocation method employed.

    Comment: Some commenters supported CMS' proposal to extend its transition policy an additional year and determine imaging APC relative payment weights for CY 2020 using cost data from all providers.

    Response: We thank the commenters for their support.

    Comment: Some commenters recommended that CMS discontinue the use of CT and MRI cost centers for developing CT and MRI CCRs and use a single diagnostic radiology CCR instead. One commenter suggested that CCRs for CT and MRI are inaccurate, too low, and equalize the payment rates for advanced and nonadvanced imaging. This commenter also noted that if CMS were to use CCRs from all cost allocation methods, including “square feet,” such a change would impact technical payments under the Medicare Physician Fee Schedule because OPPS payments for imaging services would fall below the technical payments for such services under the Medicare Physician Fee Schedule and would require a reduction as required by section 1848(b)(4) of the Act.

    Further, the commenter noted that a significant number of CT and MRI CCRs are close to zero. The commenter suggested that this probably reflects that the costs of the equipment and dedicated space for these services are likely spread across to other departments of hospitals. The commenter also suggested that hospitals have standard accounting practices for high-cost moveable equipment and that it would be burdensome and inconsistent to apply a different standard for costs associated with CT and MRI.

    Response: We appreciate the comments regarding the use of standard CT and MRI cost center CCRs. As we stated in prior rulemaking, we recognize the concerns with regard to the application of the CT and MRI standard cost center CCRs and their use in OPPS ratesetting in lieu of the previously used single diagnostic radiology CCR. As compared to the IPPS, there is greater sensitivity to the cost allocation method being used on the cost report forms for these relatively new standard imaging cost centers under the OPPS due to the limited size of the OPPS payment bundles and because the OPPS applies the CCRs at the departmental level for cost estimation purposes. However, we note that since the time we initially established the transition policy in the OPPS, we have made changes toward making the OPPS more of a prospective payment system, including greater packaging and the development of the comprehensive APCs. As we have made changes to package a greater number of items and services with imaging payments under the OPPS, and CT and MRI procedures are not solely based on the CCR applied to each procedure, we believe there is less sensitivity to imaging payments that is attributable to the cost allocation method being used on the cost report forms.

    Table 3 and Table 4 below display the largest and smallest CT and MRI CCRs based on the cost allocation method, respectively. Specifically, Tables 3 and 4 display the minimum, 5th percentile, 10th percentile, 90th percentile, 95th percentile, and maximum CCRs based on the cost allocation method. While we note that there are differences in CT and MRI CCR values by the cost allocation method, we also note that the CT CCR distributions and MRI CCR distributions are largely similar across the cost allocation method. As stated in past rulemaking, we also note that our current trimming methodology excludes CCRs that are +/−3 standard deviations from the geometric mean. While we acknowledge the commenter's concern that a number of CCRs, particular those CT CCRs from hospitals that use a cost allocation method of “square feet,” are below 0.0100, we do not believe it would be appropriate to modify our standard trimming methodology because it is not our general policy to judge the accuracy of hospital charging and hospital cost reporting practices for purposes of ratesetting.

    ER21NO18.003 ER21NO18.004 BILLING CODE 4120-01-C

    In addition, as we stated in the CY 2014 OPPS/ASC final rule with comment period (78 FR 74845), we have noted the potential impact the CT and MRI CCRs may have on other payment systems. We understand that payment reductions for imaging services under the OPPS could have significant payment impacts under the Physician Fee Schedule where the technical component payment for many imaging services is capped at the OPPS payment amount. We will continue to monitor OPPS imaging payments in the future and consider the potential impacts of payment changes to other payment systems.

    Over the past several years, we have encouraged hospitals to use more precise cost reporting methods through cost reporting instructions and communication with Medicare contractors regarding the approval of hospitals' request to switch from the square feet statistical allocation method. While we have not seen a substantial decline in the number of hospitals that use the square feet cost allocation method, and we acknowledge that there are costs and challenges with transitioning to a different accounting method for CT and MRI costs, we continue to believe that adopting CT and MRI cost center CCRs fosters more specific cost reporting and improves the data contained in the electronic cost report data files and, therefore, the accuracy of our cost estimation process for the OPPS relative weights. Therefore, for CY 2019, after consideration of the public comments we received, for CY 2019, we are finalizing our proposal to extend our transition policy for 1 additional year and continue to remove claims from providers that use a “square feet” cost allocation method to calculate CT and MRI CCRs for the CY 2019 OPPS.

    2. Data Development Process and Calculation of Costs Used for Ratesetting

    In this section of this final rule with comment period, we discuss the use of claims to calculate the OPPS payment rates for CY 2019. The Hospital OPPS page on the CMS website on which this final rule is posted (http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/HospitalOutpatientPPS/index.html) provides an accounting of claims used in the development of the final payment rates. That accounting provides additional detail regarding the number of claims derived at each stage of the process. In addition, below in this section we discuss the file of claims that comprises the data set that is available upon payment of an administrative fee under a CMS data use agreement. The CMS website, http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/HospitalOutpatientPPS/index.html, includes information about obtaining the “OPPS Limited Data Set,” which now includes the additional variables previously available only in the OPPS Identifiable Data Set, including ICD-10-CM diagnosis codes and revenue code payment amounts. This file is derived from the CY 2017 claims that were used to calculate the final payment rates for this CY 2019 OPPS/ASC final rule with comment period.

    Previously, the OPPS established the scaled relative weights, on which payments are based using APC median costs, a process described in the CY 2012 OPPS/ASC final rule with comment period (76 FR 74188). However, as discussed in more detail in section II.A.2.f. of the CY 2013 OPPS/ASC final rule with comment period (77 FR 68259 through 68271), we finalized the use of geometric mean costs to calculate the relative weights on which the CY 2013 OPPS payment rates were based. While this policy changed the cost metric on which the relative payments are based, the data process in general remained the same, under the methodologies that we used to obtain appropriate claims data and accurate cost information in determining estimated service cost. In the CY 2019 OPPS/ASC proposed rule (83 FR 37057), we proposed to continue to use geometric mean costs to calculate the relative weights on which the CY 2019 OPPS payment rates are based.

    Comment: One commenter believed that revenue code 0815 (Allogeneic Stem Cell Acquisition Services) was inadvertently excluded from the packaged revenue code list for use in the OPPS ratesetting. The commenter stated that this would primarily have an impact on APC 5244 (Level 4 Blood Product Exchange and Related Services) which would potentially include those packaged costs. The commenter requested that CMS include revenue code 0815 on the packaged revenue code list in order to be consistent with the C-APC ratesetting approach from prior years.

    Response: We thank the commenter for bringing this omission to our attention. As discussed in the CY 2018 OPPS/ASC final rule with comment period (81 FR 79586), beginning in CY 2017, we would include the revenue code for purposes of identifying costs associated with stem cell transplants. We agree that the revenue code was inadvertently not included on the packaged revenue code list and therefore have included it in this final rule with comment period for the CY 2019 OPPS ratesetting.

    After consideration of the public comment on the proposed process we received, we are adding revenue code 0815 to the packaged revenue code list and are finalizing our proposed methodology for calculating geometric mean costs for purposes of creating relative payment weights and subsequent APC payment rates for the CY 2019 OPPS. For more information regarding the stem cell transplants, we refer readers to section II.A.2.b. of this final rule with comment period. We used the methodology described in sections II.A.2.a. through II.A.2.c. of this final rule with comment period to calculate the costs we used to establish the relative payment weights used in calculating the OPPS payment rates for CY 2019 shown in Addenda A and B to this final rule with comment period (which are available via the internet on the CMS website). We refer readers to section II.A.4. of this final rule with comment period for a discussion of the conversion of APC costs to scaled payment weights.

    We note that this is the first year in which claims data containing lines with the modifier “PN” are available, which indicate nonexcepted items and services furnished and billed by off-campus provider-based departments (PBDs) of hospitals. Because nonexcepted services are not paid under the OPPS, in the CY 2019 OPPS/ASC proposed rule (83 FR 37057), we proposed to remove those claim lines reported with modifier “PN” from the claims data used in ratesetting for the CY 2019 OPPS and subsequent years.

    Comment: One commenter requested that CMS not finalize the removal of claims with modifier “PN” from the CY 2019 OPPS and future ratesetting. The commenter believed that this could result in unfair adjustments against hospital outpatient departments with large off-campus PBD presence and that CMS should perform ratesetting with and without the modifier in CY 2020 and continue to gather stakeholder input until the impact of removing those lines is fully understood.

    Response: While we generally attempt to obtain more information from the claims and cost data available to us, we do so to obtain accurate cost information for OPPS services. As discussed in the proposed rule, we do not believe that lines with modifier “PN” should be included as part of the OPPS ratesetting process because they are paid under the otherwise applicable payment system, rather than the OPPS (83 FR 37056 and 37057). We note that the impact of removing these modifier “PN” lines has only a nominal effect on the APC geometric mean costs due to the relatively low number of claims reported with modifier “PN”.

    After consideration of the public comment we received, we are finalizing the policy of removing lines with the “PN” modifier as proposed.

    For details of the claims process used in this final rule with comment period, we refer readers to the claims accounting narrative under supporting documentation for this CY 2019 OPPS/ASC final rule with comment period on the CMS website at: http://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/HospitalOutpatientPPS/index.html.

    a. Calculation of Single Procedure APC Criteria-Based Costs (1) Blood and Blood Products (a) Methodology

    Since the implementation of the OPPS in August 2000, we have made separate payments for blood and blood products through APCs rather than packaging payment for them into payments for the procedures with which they are administered. Hospital payments for the costs of blood and blood products, as well as for the costs of collecting, processing, and storing blood and blood products, are made through the OPPS payments for specific blood product APCs.

    In the CY 2019 OPPS/ASC proposed rule (83 FR 37057 through 37058), we proposed to continue to establish payment rates for blood and blood products using our blood-specific CCR methodology, which utilizes actual or simulated CCRs from the most recently available hospital cost reports to convert hospital charges for blood and blood products to costs. This methodology has been our standard ratesetting methodology for blood and blood products since CY 2005. It was developed in response to data analysis indicating that there was a significant difference in CCRs for those hospitals with and without blood-specific cost centers, and past public comments indicating that the former OPPS policy of defaulting to the overall hospital CCR for hospitals not reporting a blood-specific cost center often resulted in an underestimation of the true hospital costs for blood and blood products. Specifically, in order to address the differences in CCRs and to better reflect hospitals' costs, we proposed to continue to simulate blood CCRs for each hospital that does not report a blood cost center by calculating the ratio of the blood-specific CCRs to hospitals' overall CCRs for those hospitals that do report costs and charges for blood cost centers. We also proposed to apply this mean ratio to the overall CCRs of hospitals not reporting costs and charges for blood cost centers on their cost reports in order to simulate blood-specific CCRs for those hospitals. We proposed to calculate the costs upon which the proposed CY 2019 payment rates for blood and blood products are based using the actual blood-specific CCR for hospitals that reported costs and charges for a blood cost center and a hospital-specific, simulated blood-specific CCR for hospitals that did not report costs and charges for a blood cost center.

    We continue to believe that the hospital-specific, simulated blood-specific, CCR methodology better responds to the absence of a blood-specific CCR for a hospital than alternative methodologies, such as defaulting to the overall hospital CCR or applying an average blood-specific CCR across hospitals. Because this methodology takes into account the unique charging and cost accounting structure of each hospital, we believe that it yields more accurate estimated costs for these products. We stated in the proposed rule that we continue to believe that this methodology in CY 2019 would result in costs for blood and blood products that appropriately reflect the relative estimated costs of these products for hospitals without blood cost centers and, therefore, for these blood products in general.

    We note that, as discussed in section II.A.2.b. of the CY 2018 OPPS/ASC final rule with comment period (82 FR 59234 through 59239), we defined a comprehensive APC (C-APC) as a classification for the provision of a primary service and all adjunctive services provided to support the delivery of the primary service. Under this policy, we include the costs of blood and blood products when calculating the overall costs of these C-APCs. In the CY 2019 OPPS/ASC proposed rule (83 FR 37057 through 37058), we proposed to continue to apply the blood-specific CCR methodology described in this section when calculating the costs of the blood and blood products that appear on claims with services assigned to the C-APCs. Because the costs of blood and blood products would be reflected in the overall costs of the C-APCs (and, as a result, in the payment rates of the C-APCs), we proposed to not make separate payments for blood and blood products when they appear on the same claims as services assigned to the C-APCs (we refer readers to the CY 2015 OPPS/ASC final rule with comment period (79 FR 66796)).

    We also referred readers to Addendum B to the CY 2019 OPPS/ASC proposed rule (which is available via the internet on the CMS website) for the proposed CY 2019 payment rates for blood and blood products (which are identified with status indicator “R”). For a more detailed discussion of the blood-specific CCR methodology, we refer readers to the CY 2005 OPPS proposed rule (69 FR 50524 through 50525). For a full history of OPPS payment for blood and blood products, we refer readers to the CY 2008 OPPS/ASC final rule with comment period (72 FR 66807 through 66810).

    We did not receive any public comments for these proposals. Therefore, we are finalizing our proposals, without modification, to continue to apply the blood-specific CCR methodology described in this section when calculating the costs of the blood and blood products that appear on claims with services assigned to the C-APCs and to not make separate payments for blood and blood products when they appear on the same claims as services assigned to the C-APCs for CY 2019.

    (b) Pathogen-Reduced Platelets Payment Rate

    In the CY 2016 OPPS/ASC final rule with comment period (80 FR 70322 through 70323), we reiterated that we calculate payment rates for blood and blood products using our blood-specific CCR methodology, which utilizes actual or simulated CCRs from the most recently available hospital cost reports to convert hospital charges for blood and blood products to costs. Because HCPCS code P9072 (Platelets, pheresis, pathogen reduced or rapid bacterial tested, each unit), the predecessor code to HCPCS code P9073 (Platelets, pheresis, pathogen-reduced, each unit), was new for CY 2016, there were no claims data available on the charges and costs for this blood product upon which to apply our blood-specific CCR methodology. Therefore, we established an interim payment rate for HCPCS code P9072 based on a crosswalk to existing blood product HCPCS code P9037 (Platelets, pheresis, leukocytes reduced, irradiated, each unit), which we believed provided the best proxy for the costs of the new blood product. In addition, we stated that once we had claims data for HCPCS code P9072, we would calculate its payment rate using the claims data that should be available for the code beginning in CY 2018, which is our practice for other blood product HCPCS codes for which claims data have been available for 2 years.

    We stated in the CY 2018 OPPS/ASC final rule with comment period (82 FR 59232) that, although our standard practice for new codes involves using claims data to set payment rates once claims data become available, we were concerned that there may have been confusion among the provider community about the services that HCPCS code P9072 described. That is, as early as 2016, there were discussions about changing the descriptor for HCPCS code P9072 to include the phrase “or rapid bacterial tested”, which is a less costly technology than pathogen reduction. In addition, effective January 2017, the code descriptor for HCPCS code P9072 was changed to describe rapid bacterial testing of platelets and, effective July 1, 2017, the descriptor for the temporary successor code for HCPCS code P9072 (HCPCS code Q9988) was changed again back to the original descriptor for HCPCS code P9072 that was in place for 2016.

    Based on the ongoing discussions involving changes to the original HCPCS code P9072 established in CY 2016, we believed that claims from CY 2016 for pathogen reduced platelets may have potentially reflected certain claims for rapid bacterial testing of platelets. Therefore, we decided to continue to crosswalk the payment amount for services described by HCPCS code P9073 to the payment amount for services described by HCPCS P9037 for CY 2018 (82 FR 59232), as had been done previously, to determine the payment rate for services described by HCPCS code P9072. In the CY 2019 OPPS/ASC proposed rule (83 FR 37058), for CY 2019, we discussed that we had reviewed the CY 2017 claims data for the two predecessor codes to HCPCS code P9073 (HCPCS codes P9072 and Q9988), along with the claims data for the CY 2017 temporary code for pathogen test for platelets (HCPCS code Q9987), which describes rapid bacterial testing of platelets.

    We found that there were over 2,200 claims billed with either HCPCS code P9072 or Q9988. Accordingly, we believe that there are a sufficient number of claims to use to calculate a payment rate for HCPCS code P9073 for CY 2019. We also performed checks to estimate the share of claims that may have been billed for rapid bacterial testing of platelets as compared to the share of claims that may have been billed for pathogen-reduced, pheresis platelets (based on when HCPCS code P9072 was an active procedure code from January 1, 2017 to June 30, 2017). First, we found that the geometric mean cost for pathogen-reduced, pheresis platelets, as reported by HCPCS code Q9988 when billed separately from rapid bacterial testing of platelets, was $453.87, and that over 1,200 claims were billed for services described by HCPCS code Q9988. Next, we found that the geometric mean cost for rapid bacterial testing of platelets, as reported by HCPCS code Q9987 on claims, was $33.44, and there were 59 claims reported for services described by HCPCS code Q9987, of which 3 were separately paid.

    These findings imply that almost all of the claims billed for services reported with HCPCS code P9072 were for pathogen-reduced, pheresis platelets. In addition, the geometric mean cost for services described by HCPCS code P9072, which may contain rapid bacterial testing of platelets claims, was $468.11, which is higher than the geometric mean cost for services described by HCPCS code Q9988 of $453.87, which should not have contained claims for rapid bacterial testing of platelets. Because the geometric mean for services described by HCPCS code Q9987 is only $33.44, it would be expected that if a significant share of claims billed for services described by HCPCS code P9072 were for the rapid bacterial testing of platelets, the geometric mean cost for services described by HCPCS code P9072 would be lower than the geometric mean cost for services described by HCPCS code Q9988. Instead, we found that the geometric mean cost for services described by HCPCS code Q9988 is higher than the geometric mean cost for services described by HCPCS code P9072.

    Based on our analysis of claims data, we stated in the CY 2019 OPPS/ASC proposed rule that we believed there were sufficient claims available to establish a payment rate for pathogen-reduced pheresis platelets without using a crosswalk. Therefore, we proposed to calculate the payment rate for services described by HCPCS code P9073 in CY 2019 and in subsequent years using claims payment history, which is the standard methodology used by the OPPS for HCPCS and CPT codes with at least 2 years of claims history. We referred readers to Addendum B of the proposed rule for the proposed payment rate for services described by HCPCS code P9073 reportable under the OPPS. Addendum B is available via the internet on the CMS website.

    Comment: Several commenters opposed the proposal to use claims history to calculate the payment rate for services described by HCPCS code P9073. Instead, the commenters requested that CMS calculate the payment rate for services described by HCPCS code P9072 based on a crosswalk to existing blood product HCPCS code P9037 through either CY 2019 or CY 2020. The commenters stated that the acquisition cost for pathogen-reduced platelets is over $600, which is substantially higher than the proposed payment rate for services described by HCPCS code P9073 found in Addendum B to the proposed rule and closer to the payment rate for services described by HCPCS code P9073. Some commenters indicated that the cost for pathogen-reduced platelets is higher than the cost of leukocytes reduced and irradiated platelets, the product covered by HCPCS code P9073, the crosswalked code. Several of the commenters believed the claim costs for pathogen-reduced platelets were lower than actual costs because of coding errors by providers, providers who did not use pathogen-reduced platelets billing the service, and confusion over whether to use the hospital CCR or the blood center CCR to report charges for pathogen-reduced platelets. One commenter also stated that a provider that billed several claims for pathogen-reduced platelets believed that CMS assigned an unusually low CCR to its claims, leading the provider to report lower than actual costs for the service.

    Response: We appreciate the concerns of the commenters. Pathogen-reduced platelets (HCPCS code P9073) are a relatively new service. As we noted in the CY 2019 OPPS/ASC proposed rule (83 FR 37058), there were many changes to the procedure code billed for pathogen-reduced platelets, as well as with the services covered by the procedure codes for pathogen-reduced platelets and the code descriptors. We had concerns that all of these coding changes could lead to billing confusion. The comments we received from providers, stakeholder groups, and the developer of the pathogen-reduced technology support that there indeed may have been confusion about billing that has led to aberrancies in the data we have available for ratesetting.

    After consideration of the public comments we received, we are not finalizing our proposal to calculate the payment rate for services described by HCPCS code P9073 in CY 2019 using claims payment history. Instead, for CY 2019 (that is, for one more year), we are establishing the payment rate for services described by HCPCS code P9073 by performing a crosswalk from the payment amount for services described by HCPCS code P9073 to the payment amount for services described by HCPCS P9037. We refer readers to Addendum B to this final rule with comment period for the final payment rate for services described by HCPCS code P9073 reportable under the OPPS. Addendum B is available via the internet on the CMS website.

    (2) Brachytherapy Sources

    Section 1833(t)(2)(H) of the Act mandates the creation of additional groups of covered OPD services that classify devices of brachytherapy consisting of a seed or seeds (or radioactive source) (“brachytherapy sources”) separately from other services or groups of services. The statute provides certain criteria for the additional groups. For the history of OPPS payment for brachytherapy sources, we refer readers to prior OPPS final rules, such as the CY 2012 OPPS/ASC final rule with comment period (77 FR 68240 through 68241). As we have stated in prior OPPS updates, we believe that adopting the general OPPS prospective payment methodology for brachytherapy sources is appropriate for a number of reasons (77 FR 68240). The general OPPS methodology uses costs based on claims data to set the relative payment weights for hospital outpatient services. This payment methodology results in more consistent, predictable, and equitable payment amounts per source across hospitals by averaging the extremely high and low values, in contrast to payment based on hospitals' charges adjusted to costs. We believe that the OPPS methodology, as opposed to payment based on hospitals' charges adjusted to cost, also would provide hospitals with incentives for efficiency in the provision of brachytherapy services to Medicare beneficiaries. Moreover, this approach is consistent with our payment methodology for the vast majority of items and services paid under the OPPS. We refer readers to the CY 2016 OPPS/ASC final rule with comment period (80 FR 70323 through 70325) for further discussion of the history of OPPS payment for brachytherapy sources.

    In the CY 2019 OPPS/ASC proposed rule (83 FR 37059), for CY 2019, we proposed to use the costs derived from CY 2017 claims data to set the proposed CY 2019 payment rates for brachytherapy sources because CY 2017 is the same year of data we proposed to use to set the proposed payment rates for most other items and services that would be paid under the CY 2019 OPPS. We proposed to base the payment rates for brachytherapy sources on the geometric mean unit costs for each source, consistent with the methodology that we proposed for other items and services paid under the OPPS, as discussed in section II.A.2. of the proposed rule. We also proposed to continue the other payment policies for brachytherapy sources that we finalized and first implemented in the CY 2010 OPPS/ASC final rule with comment period (74 FR 60537). We proposed to pay for the stranded and nonstranded not otherwise specified (NOS) codes, HCPCS codes C2698 (Brachytherapy source, stranded, not otherwise specified, per source) and C2699 (Brachytherapy source, non-stranded, not otherwise specified, per source), at a rate equal to the lowest stranded or nonstranded prospective payment rate for such sources, respectively, on a per source basis (as opposed to, for example, a per mCi), which is based on the policy we established in the CY 2008 OPPS/ASC final rule with comment period (72 FR 66785). We also proposed to continue the policy we first implemented in the CY 2010 OPPS/ASC final rule with comment period (74 FR 60537) regarding payment for new brachytherapy sources for which we have no claims data, based on the same reasons we discussed in the CY 2008 OPPS/ASC final rule with comment period (72 FR 66786; which was delayed until January 1, 2010 by section 142 of Pub. L. 110-275). Specifically, this policy is intended to enable us to assign new HCPCS codes for new brachytherapy sources to their own APCs, with prospective payment rates set based on our consideration of external data and other relevant information regarding the expected costs of the sources to hospitals. The proposed CY 2019 payment rates for brachytherapy sources were included in Addendum B to the proposed rule (which is available via the internet on the CMS website) and were identified with status indicator “U”. For CY 2019, we proposed to continue to assign status indicator “U” (Brachytherapy Sources, Paid under OPPS; separate APC payment) to HCPCS code C2645 (Brachytherapy planar source, palladium-103, per square millimeter) and to use external data (invoice prices) and other relevant information to establish the proposed APC payment rate for HCPCS code C2645. Specifically, we proposed to set the payment rate at $4.69 per mm2, the same rate that was in effect for CYs 2017 and 2018.

    We note that, for CY 2019, we proposed to assign status indicator “E2” (Items and Services for Which Pricing Information and Claims Data Are Not Available) to HCPCS code C2644 (Brachytherapy cesium-131 chloride) because this code was not reported on CY 2017 claims. Therefore, we were unable to calculate a proposed payment rate based on the general OPPS ratesetting methodology described earlier. Although HCPCS code C2644 became effective July 1, 2014, there are no CY 2017 claims reporting this code. Therefore, we proposed to assign new proposed status indicator “E2” to HCPCS code C2644 in the CY 2019 OPPS.

    Comment: One commenter expressed concern regarding CMS' policy to establish prospective payment rates for brachytherapy sources using the general OPPS methodology, which uses costs based on claims data to set the relative payment weights for hospital outpatient services. The commenter stated that, as a result of use of these cost data from claims, payments for low-volume brachytherapy sources have fluctuated significantly under the OPPS.

    Response: As we stated in the CY 2012 OPPS/ASC final rule with comment period (76 FR 74161) when we established a prospective payment for brachytherapy sources, the OPPS relies on the concept of averaging, where the payment may be more or less than the estimated cost of providing a service for a particular patient; however, with the exception of outlier cases, we believe that such a prospective payment is adequate to ensure access to appropriate care. We acknowledge that payment for brachytherapy sources based on geometric mean costs from a small set of claims may be more variable on a year-to-year basis when compared to geometric mean costs for brachytherapy sources from a larger claims set. However, as illustrated in Table 5 below, we believe that payment for currently payable brachytherapy sources has been relatively consistent over the years and that a prospective payment for brachytherapy sources based on geometric mean costs is appropriate and provides hospitals with the greatest incentives for efficiency in furnishing brachytherapy treatment. For CY 2019 OPPS payment rates for the brachytherapy sources listed in Table 5, we refer readers to Addendum B of this final rule with comment period (which is available via the internet on the CMS website).

    BILLING CODE 4120-01-P ER21NO18.005 BILLING CODE 4120-01-C

    After consideration of the public comments we received, we are finalizing our proposal to continue to set the payment rates for brachytherapy sources using our established prospective payment methodology. We also are finalizing our proposal to assign status indicator “U” (Brachytherapy Sources, Paid under OPPS; separate APC payment) to HCPCS code C2645 (Brachytherapy planar source, palladium-103, per square millimeter) and to use external data (invoice prices) and other relevant information to establish the APC payment rate for HCPCS code C2645 for CY 2019.

    Lastly, because we were unable to calculate a payment rate for HCPCS code C2644 (Brachytherapy cesium-131 chloride) based on the general OPPS ratesetting methodology, we are finalizing our proposal to assign HCPCS code C2644 status indicator “E2” (Items and Services for Which Pricing Information and Claims Data Are Not Available) for CY 2019.

    The final CY 2019 payment rates for brachytherapy sources are included in Addendum B to this final rule with comment period (which is available via the internet on the CMS website) and are identified with status indicator “U”.

    We continue to invite hospitals and other parties to submit recommendations to us for new codes to describe new brachytherapy sources. Such recommendations should be directed to the Division of Outpatient Care, Mail Stop C4-01-26, Centers for Medicare and Medicaid Services, 7500 Security Boulevard, Baltimore, MD 21244. We will continue to add new brachytherapy source codes and descriptors to our systems for payment on a quarterly basis.

    b. Comprehensive APCs (C-APCs) for CY 2019 (1) Background

    In the CY 2014 OPPS/ASC final rule with comment period (78 FR 74861 through 74910), we finalized a comprehensive payment policy that packages payment for adjunctive and secondary items, services, and procedures into the most costly primary procedure under the OPPS at the claim level. The policy was finalized in CY 2014, but the effective date was delayed until January 1, 2015, to allow additional time for further analysis, opportunity for public comment, and systems preparation. The comprehensive APC (C-APC) policy was implemented effective January 1, 2015, with modifications and clarifications in response to public comments received regarding specific provisions of the C-APC policy (79 FR 66798 through 66810).

    A C-APC is defined as a classification for the provision of a primary service and all adjunctive services provided to support the delivery of the primary service. We established C-APCs as a category broadly for OPPS payment and implemented 25 C-APCs beginning in CY 2015 (79 FR 66809 through 66810). In the CY 2016 OPPS/ASC final rule with comment period (80 FR 70332), we finalized 10 additional C-APCs to be paid under the existing C-APC payment policy and added one additional level to both the Orthopedic Surgery and Vascular Procedures clinical families, which increased the total number of C-APCs to 37 for CY 2016. In the CY 2017 OPPS/ASC final rule with comment period (81 FR 79584 through 79585), we finalized another 25 C-APCs for a total of 62 C-APCs. In the CY 2018 OPPS/ASC final rule with comment period, we did not change the total number of C-APCs from 62.

    Under this policy, we designate a service described by a HCPCS code assigned to a C-APC as the primary service when the service is identified by OPPS status indicator “J1”. When such a primary service is reported on a hospital outpatient claim, taking into consideration the few exceptions that are discussed below, we make payment for all other items and services reported on the hospital outpatient claim as being integral, ancillary, supportive, dependent, and adjunctive to the primary service (hereinafter collectively referred to as “adjunctive services”) and representing components of a complete comprehensive service (78 FR 74865 and 79 FR 66799). Payments for adjunctive services are packaged into the payments for the primary services. This results in a single prospective payment for each of the primary, comprehensive services based on the costs of all reported services at the claim level.

    Services excluded from the C-APC policy under the OPPS include services that are not covered OPD services, services that cannot by statute be paid for under the OPPS, and services that are required by statute to be separately paid. This includes certain mammography and ambulance services that are not covered OPD services in accordance with section 1833(t)(1)(B)(iv) of the Act; brachytherapy seeds, which also are required by statute to receive separate payment under section 1833(t)(2)(H) of the Act; pass-through payment drugs and devices, which also require separate payment under section 1833(t)(6) of the Act; self-administered drugs (SADs) that are not otherwise packaged as supplies because they are not covered under Medicare Part B under section 1861(s)(2)(B) of the Act; and certain preventive services (78 FR 74865 and 79 FR 66800 through 66801). A list of services excluded from the C-APC policy is included in Addendum J to this final rule with comment period (which is available via the internet on the CMS website).

    The C-APC policy payment methodology set forth in the CY 2014 OPPS/ASC final rule with comment period for the C-APCs and modified and implemented beginning in CY 2015 is summarized as follows (78 FR 74887 and 79 FR 66800):

    Basic Methodology. As stated in the CY 2015 OPPS/ASC final rule with comment period, we define the C-APC payment policy as including all covered OPD services on a hospital outpatient claim reporting a primary service that is assigned to status indicator “J1”, excluding services that are not covered OPD services or that cannot by statute be paid for under the OPPS. Services and procedures described by HCPCS codes assigned to status indicator “J1” are assigned to C-APCs based on our usual APC assignment methodology by evaluating the geometric mean costs of the primary service claims to establish resource similarity and the clinical characteristics of each procedure to establish clinical similarity within each APC.

    In the CY 2016 OPPS/ASC final rule with comment period, we expanded the C-APC payment methodology to qualifying extended assessment and management encounters through the “Comprehensive Observation Services” C-APC (C-APC 8011). Services within this APC are assigned status indicator “J2”. Specifically, we make a payment through C-APC 8011 for a claim that:

    • Does not contain a procedure described by a HCPCS code to which we have assigned status indicator “T” that is reported with a date of service on the same day or 1 day earlier than the date of service associated with services described by HCPCS code G0378;

    • Contains 8 or more units of services described by HCPCS code G0378 (Hospital observation services, per hour);

    • Contains services provided on the same date of service or 1 day before the date of service for HCPCS code G0378 that are described by one of the following codes: HCPCS code G0379 (Direct admission of patient for hospital observation care) on the same date of service as HCPCS code G0378; CPT code 99281 (Emergency department visit for the evaluation and management of a patient (Level 1)); CPT code 99282 (Emergency department visit for the evaluation and management of a patient (Level 2)); CPT code 99283 (Emergency department visit for the evaluation and management of a patient (Level 3)); CPT code 99284 (Emergency department visit for the evaluation and management of a patient (Level 4)); CPT code 99285 (Emergency department visit for the evaluation and management of a patient (Level 5)) or HCPCS code G0380 (Type B emergency department visit (Level 1)); HCPCS code G0381 (Type B emergency department visit (Level 2)); HCPCS code G0382 (Type B emergency department visit (Level 3)); HCPCS code G0383 (Type B emergency department visit (Level 4)); HCPCS code G0384 (Type B emergency department visit (Level 5)); CPT code 99291 (Critical care, evaluation and management of the critically ill or critically injured patient; first 30-74 minutes); or HCPCS code G0463 (Hospital outpatient clinic visit for assessment and management of a patient); and

    • Does not contain services described by a HCPCS code to which we have assigned status indicator “J1”.

    The assignment of status indicator “J2” to a specific combination of services performed in combination with each other allows for all other OPPS payable services and items reported on the claim (excluding services that are not covered OPD services or that cannot by statute be paid for under the OPPS) to be deemed adjunctive services representing components of a comprehensive service and resulting in a single prospective payment for the comprehensive service based on the costs of all reported services on the claim (80 FR 70333 through 70336).

    Services included under the C-APC payment packaging policy, that is, services that are typically adjunctive to the primary service and provided during the delivery of the comprehensive service, include diagnostic procedures, laboratory tests, and other diagnostic tests and treatments that assist in the delivery of the primary procedure; visits and evaluations performed in association with the procedure; uncoded services and supplies used during the service; durable medical equipment as well as prosthetic and orthotic items and supplies when provided as part of the outpatient service; and any other components reported by HCPCS codes that represent services that are provided during the complete comprehensive service (78 FR 74865 and 79 FR 66800).

    In addition, payment for hospital outpatient department services that are similar to therapy services and delivered either by therapists or nontherapists is included as part of the payment for the packaged complete comprehensive service. These services that are provided during the perioperative period are adjunctive services and are deemed not to be therapy services as described in section 1834(k) of the Act, regardless of whether the services are delivered by therapists or other nontherapist health care workers. We have previously noted that therapy services are those provided by therapists under a plan of care in accordance with section 1835(a)(2)(C) and section 1835(a)(2)(D) of the Act and are paid for under section 1834(k) of the Act, subject to annual therapy caps as applicable (78 FR 74867 and 79 FR 66800). However, certain other services similar to therapy services are considered and paid for as hospital outpatient department services. Payment for these nontherapy outpatient department services that are reported with therapy codes and provided with a comprehensive service is included in the payment for the packaged complete comprehensive service. We note that these services, even though they are reported with therapy codes, are hospital outpatient department services and not therapy services. Therefore, the requirement for functional reporting under the regulations at 42 CFR 410.59(a)(4) and 42 CFR 410.60(a)(4) does not apply. We refer readers to the July 2016 OPPS Change Request 9658 (Transmittal 3523) for further instructions on reporting these services in the context of a C-APC service.

    Items included in the packaged payment provided in conjunction with the primary service also include all drugs, biologicals, and radiopharmaceuticals, regardless of cost, except those drugs with pass-through payment status and SADs, unless they function as packaged supplies (78 FR 74868 through 74869 and 74909 and 79 FR 66800). We refer readers to Section 50.2M, Chapter 15, of the Medicare Benefit Policy Manual for a description of our policy on SADs treated as hospital outpatient supplies, including lists of SADs that function as supplies and those that do not function as supplies.

    We define each hospital outpatient claim reporting a single unit of a single primary service assigned to status indicator “J1” as a single “J1” unit procedure claim (78 FR 74871 and 79 FR 66801). Line item charges for services included on the C-APC claim are converted to line item costs, which are then summed to develop the estimated APC costs. These claims are then assigned one unit of the service with status indicator “J1” and later used to develop the geometric mean costs for the C-APC relative payment weights. (We note that we use the term “comprehensive” to describe the geometric mean cost of a claim reporting “J1” service(s) or the geometric mean cost of a C-APC, inclusive of all of the items and services included in the C-APC service payment bundle.) Charges for services that would otherwise be separately payable are added to the charges for the primary service. This process differs from our traditional cost accounting methodology only in that all such services on the claim are packaged (except certain services as described above). We apply our standard data trims, which exclude claims with extremely high primary units or extreme costs.

    The comprehensive geometric mean costs are used to establish resource similarity and, along with clinical similarity, dictate the assignment of the primary services to the C-APCs. We establish a ranking of each primary service (single unit only) to be assigned to status indicator “J1” according to its comprehensive geometric mean costs. For the minority of claims reporting more than one primary service assigned to status indicator “J1” or units thereof, we identify one “J1” service as the primary service for the claim based on our cost-based ranking of primary services. We then assign these multiple “J1” procedure claims to the C-APC to which the service designated as the primary service is assigned. If the reported “J1” services on a claim map to different C-APCs, we designate the “J1” service assigned to the C-APC with the highest comprehensive geometric mean cost as the primary service for that claim. If the reported multiple “J1” services on a claim map to the same C-APC, we designate the most costly service (at the HCPCS code level) as the primary service for that claim. This process results in initial assignments of claims for the primary services assigned to status indicator “J1” to the most appropriate C-APCs based on both single and multiple procedure claims reporting these services and clinical and resource homogeneity.

    Complexity Adjustments. We use complexity adjustments to provide increased payment for certain comprehensive services. We apply a complexity adjustment by promoting qualifying paired “J1” service code combinations or paired code combinations of “J1” services and certain add-on codes (as described further below) from the originating C-APC (the C-APC to which the designated primary service is first assigned) to the next higher paying C-APC in the same clinical family of C-APCs. We apply this type of complexity adjustment when the paired code combination represents a complex, costly form or version of the primary service according to the following criteria:

    • Frequency of 25 or more claims reporting the code combination (frequency threshold); and

    • Violation of the 2 times rule in the originating C-APC (cost threshold).

    These criteria identify paired code combinations that occur commonly and exhibit materially greater resource requirements than the primary service. The CY 2017 OPPS/ASC final rule with comment period (81 FR 79582) included a revision to the complexity adjustment eligibility criteria. Specifically, we finalized a policy to discontinue the requirement that a code combination (that qualifies for a complexity adjustment by satisfying the frequency and cost criteria thresholds described above) also not create a 2 times rule violation in the higher level or receiving APC.

    After designating a single primary service for a claim, we evaluate that service in combination with each of the other procedure codes reported on the claim assigned to status indicator “J1” (or certain add-on codes) to determine if there are paired code combinations that meet the complexity adjustment criteria. For a new HCPCS code, we determine initial C-APC assignment and qualification for a complexity adjustment using the best available information, crosswalking the new HCPCS code to a predecessor code(s) when appropriate.

    Once we have determined that a particular code combination of “J1” services (or combinations of “J1” services reported in conjunction with certain add-on codes) represents a complex version of the primary service because it is sufficiently costly, frequent, and a subset of the primary comprehensive service overall according to the criteria described above, we promote the claim including the complex version of the primary service as described by the code combination to the next higher cost C-APC within the clinical family, unless the primary service is already assigned to the highest cost APC within the C-APC clinical family or assigned to the only C-APC in a clinical family. We do not create new APCs with a comprehensive geometric mean cost that is higher than the highest geometric mean cost (or only) C-APC in a clinical family just to accommodate potential complexity adjustments. Therefore, the highest payment for any claim including a code combination for services assigned to a C-APC would be the highest paying C-APC in the clinical family (79 FR 66802).

    We package payment for all add-on codes into the payment for the C-APC. However, certain primary service add-on combinations may qualify for a complexity adjustment. As noted in the CY 2016 OPPS/ASC final rule with comment period (80 FR 70331), all add-on codes that can be appropriately reported in combination with a base code that describes a primary “J1” service are evaluated for a complexity adjustment.

    To determine which combinations of primary service codes reported in conjunction with an add-on code may qualify for a complexity adjustment for CY 2019, in the CY 2019 OPPS/ASC proposed rule (83 FR 37061), we proposed to apply the frequency and cost criteria thresholds discussed above, testing claims reporting one unit of a single primary service assigned to status indicator “J1” and any number of units of a single add-on code for the primary “J1” service. If the frequency and cost criteria thresholds for a complexity adjustment are met and reassignment to the next higher cost APC in the clinical family is appropriate (based on meeting the criteria outlined above), we make a complexity adjustment for the code combination; that is, we reassign the primary service code reported in conjunction with the add-on code to the next higher cost C-APC within the same clinical family of C-APCs. As previously stated, we package payment for add-on codes into the C-APC payment rate. If any add-on code reported in conjunction with the “J1” primary service code does not qualify for a complexity adjustment, payment for the add-on service continues to be packaged into the payment for the primary service and is not reassigned to the next higher cost C-APC. We listed the complexity adjustments proposed for “J1” and add-on code combinations for CY 2019, along with all of the other proposed complexity adjustments, in Addendum J to the CY 2019 OPPS/ASC proposed rule (which is available via the internet on the CMS website).

    Addendum J to the proposed rule included the cost statistics for each code combination that would qualify for a complexity adjustment (including primary code and add-on code combinations). Addendum J to the proposed rule also contained summary cost statistics for each of the paired code combinations that describe a complex code combination that would qualify for a complexity adjustment and were proposed to be reassigned to the next higher cost C-APC within the clinical family. The combined statistics for all proposed reassigned complex code combinations were represented by an alphanumeric code with the first 4 digits of the designated primary service followed by a letter. For example, the proposed geometric mean cost listed in Addendum J for the code combination described by complexity adjustment assignment 3320R, which is assigned to C-APC 5224 (Level 4 Pacemaker and Similar Procedures), includes all paired code combinations that were proposed to be reassigned to C-APC 5224 when CPT code 33208 is the primary code. Providing the information contained in Addendum J to the proposed rule allowed stakeholders the opportunity to better assess the impact associated with the proposed reassignment of claims with each of the paired code combinations eligible for a complexity adjustment.

    Comment: Several commenters requested that CMS alter the C-APC complexity adjustment eligibility criteria to allow additional code combinations to qualify for complexity adjustments. The commenters requested that CMS consider clusters of “J1” and add-on codes, rather than only code pairs, and also consider code combinations of “J1” codes and devices such as drug-coated balloons and drug-eluting stents. The commenters also requested that CMS eliminate the 25-claim frequency threshold. Another commenter requested that CMS consider patient complexity and procedures assigned to status indicator “S” or “T” when evaluating procedures for a complexity adjustment. One commenter suggested that procedures initially eligible for a complexity adjustment by meeting the applicable requirements in a year maintain that complexity adjustment for a total period of 3 years, regardless of whether they continue to meet the criteria after the first year.

    In terms of payment for complexity adjustments, one commenter requested that CMS promote the qualifying code combination to two APC levels higher than the originating APC rather than to the next higher paying C-APC. Another commenter suggested that CMS pay the geometric mean cost of the highest ranking procedure in the qualifying code combination at 100 percent, and then each secondary procedure at 50 percent of the geometric mean cost of the secondary procedure.

    Other commenters also requested an explanation of how the geometric mean costs of the code combinations evaluated for complexity adjustments are calculated, stating that the geometric mean cost of certain code combinations represented in Addendum J were lower than the geometric mean costs of the primary service when the service is billed without an additional “J1” or “J1” add-on procedure. Commenters also requested that CMS establish complexity adjustments for the specific code combinations listed in Table 6 below.

    BILLING CODE 4120-01-P ER21NO18.006 ER21NO18.007 ER21NO18.008 BILLING CODE 4120-01-C

    Response: We appreciate these comments. However, at this time, we do not believe changes to the C-APC complexity adjustment criteria are necessary or that we should make exceptions to the criteria to allow claims with the code combinations suggested by the commenters to receive complexity adjustments. As stated previously (81 FR 79582), we continue to believe that the complexity adjustment criteria, which require a frequency of 25 or more claims reporting a code combination and a violation of the 2 times rule in the originating C-APC in order to receive payment in the next higher cost C-APC within the clinical family, are adequate to determine if a combination of procedures represents a complex, costly subset of the primary service. If a code combination meets these criteria, the combination receives payment at the next higher cost C-APC. Code combinations that do not meet these criteria receive the C-APC payment rate associated with the primary “J1” service. A minimum of 25 claims is already very low for a national payment system. Lowering the minimum of 25 claims further could lead to unnecessary complexity adjustments for service combinations that are rarely performed. The complexity adjustment cost threshold compares the code combinations to the lowest cost-significant procedure assigned to the APC. If the cost of the code combination does not exceed twice the cost of the lowest cost-significant procedure within the APC, no complexity adjustment is made. Lowering or eliminating this threshold could remove so many claims from the accounting for the primary “J1” service that the geometric mean costs attributed to the primary procedure could be skewed.

    With regard to the specific complexity adjustments requested by commenters listed in Table 6 above, we note that we did not propose that claims with these code combinations would receive complexity adjustments because they did not meet the cost and frequency criteria for the adjustment. Therefore, we do not believe it is appropriate to change the complexity adjustment criteria at this time, and because the suggested code combinations do not meet the existing criteria, we do not believe it is appropriate to establish complexity adjustments for these code combinations at this time.

    Regarding the request for a code combination that qualified for a complexity adjustment in a year to continue to qualify for the adjustment for the next 2 years for a total period of 3 years, we note that we evaluate code combinations each year against our complexity adjustment criteria using the latest available data. At this time, we do not believe it is necessary to expand the ability for code combinations to meet the complexity adjustment criteria in this manner because we believe that the existing criteria that were already established sufficiently reflect those combinations of procedures that are commonly billed together and are costly enough to merit a complexity adjustment. Further, we believe that code combinations should be evaluated each year to determine if they meet the criteria based on the latest hospital billing and utilization data. We also do not believe that it is necessary to provide payment for claims including qualifying code combinations at two APC levels higher than the originating APC or for CMS to pay based on the geometric mean cost of the highest ranking procedure in the qualifying code combination at 100 percent, and then each secondary procedure based on 50 percent of the geometric mean cost of the secondary procedure. We believe that payment at the next higher paying C-APC is adequate for code combinations that exhibit materially greater resource requirements than the primary service and that, in many cases, paying the rate assigned to two levels higher may lead to a significant overpayment. As mentioned previously, we do not create new APCs with a comprehensive geometric mean cost that is higher than the highest geometric mean cost (or only) C-APC in a clinical family just to accommodate potential complexity adjustments. The highest payment for any claim including a code combination for services assigned to a C-APC would be the highest paying C-APC in the clinical family (79 FR 66802). Therefore, a policy to pay for claims with qualifying code combinations at two C-APC levels higher than the originating APC is not always feasible. Likewise, while paying 100 percent of the highest ranking procedure and paying 50 percent of the secondary procedure is the established payment policy under the multiple procedure payment reduction policy that applies to services assigned to status indicator “T,” we continue to believe that the established C-APC complexity adjustment policy is appropriate for services assigned to status indicator “J1” or “J2”, and we do not believe that it should be replaced with a multiple procedure payment reduction payment methodology.

    In response to the request for an explanation of the cost statistics for the paired “J1” code combinations or paired code combinations of “J1” services and certain add-on codes evaluated for complexity adjustments, the geometric mean costs of these code combinations shown in Addendum J are calculated using only claims that include these code pairings. As stated previously, the cost of the code combination must exceed twice the cost of the lowest cost-significant procedure within the APC in order for the combination to qualify for a complexity adjustment.

    Lastly, as stated in the CY 2018 OPPS/ASC final rule with comment period (82 FR 59238), we do not believe that it is necessary to adjust the complexity adjustment criteria to allow claims that include a drug or device code, more than two “J1” procedures, or procedures performed at certain hospitals to qualify for a complexity adjustment. As mentioned earlier, we believe the current criteria are adequate to determine if a combination of procedures represents a complex, costly subset of the primary service.

    After consideration of the public comments we received on the proposed complexity adjustment policy, we are finalizing the C-APC complexity adjustment policy for CY 2019, as proposed, without modification.

    (2) Additional C-APCs for CY 2019

    For CY 2019 and subsequent years, in the CY 2019 OPPS/ASC proposed rule (83 FR 37062), we proposed to continue to apply the C-APC payment policy methodology made effective in CY 2015 and updated with the implementation of status indicator “J2” in CY 2016. We refer readers to the CY 2017 OPPS/ASC final rule with comment period (81 FR 79583) for a discussion of the C-APC payment policy methodology and revisions.

    Each year, in accordance with section 1833(t)(9)(A) of the Act, we review and revise the services within each APC group and the APC assignments under the OPPS. As a result of our annual review of the services and the APC assignments under the OPPS, in the proposed rule (83 FR 37062), we proposed to add three C-APCs under the existing C-APC payment policy beginning in CY 2019: Proposed C-APC 5163 (Level 3 ENT Procedures); proposed C-APC 5183 (Level 3 Vascular Procedures); and proposed C-APC 5184 (Level 4 Vascular Procedures). These APCs were selected to be included in this proposal because, similar to other C-APCs, these APCs include primary, comprehensive services, such as major surgical procedures, that are typically reported with other ancillary and adjunctive services. Also, similar to other APCs that have been converted to C-APCs, there are higher APC levels within the clinical family or related clinical family of these APCs that have previously been assigned to a C-APC. Table 3 of the proposed rule listed the proposed C-APCs for CY 2019. All C-APCs were displayed in Addendum J to the proposed rule (which is available via the internet on the CMS website). Addendum J to the proposed rule also contained all of the data related to the C-APC payment policy methodology, including the list of proposed complexity adjustments and other information.

    Comment: Several commenters supported the proposals. Other commenters, including device manufacturer associations, expressed ongoing concerns that the C-APC payment rates may not adequately reflect the costs associated with the services and requested that CMS not establish any additional C-APCs. These commenters also requested that CMS provide an analysis of the impact of the C-APC policy on affected procedures.

    Response: We appreciate the commenters' responses. We continue to believe that the proposed C-APCs for CY 2019 are appropriate to be added to the existing C-APC payment policy. We also note that, in the CY 2018 OPPS/ASC final rule with comment period (82 FR 59246), we conducted an analysis of the effects of the C-APC policy. The analysis looked at data from CY 2016 OPPS/ASC final rule with comment period, the CY 2017 OPPS/ASC final rule with comment period, and the CY 2018 OPPS/ASC proposed rule, which involved claims data from CY 2014 (before C-APCs became effective) to CY 2016. We looked at separately payable codes that were then assigned to C-APCs and, overall, we observed an increase in claim line frequency, units billed, and Medicare payment for those procedures, which suggest that the C-APC payment policy did not adversely affect access to care or reduce payments to hospitals.

    Comment: Several commenters requested that CMS discontinue the C-APC payment policy for several brachytherapy insertion procedures and single session stereotactic radiosurgery procedures, stating concerns that the C-APC methodology does not account for the complexity of delivering radiation therapy and fails to capture appropriately coded claims. The commenters also requested that CMS continue to make separate payments for the 10 planning and preparation codes related to stereotactic radiosurgery (SRS) and include the HCPCS code for IMRT planning (77301) on the list of planning and preparation codes, stating that the service has become more common in single fraction radiosurgery treatment planning.

    Response: At this time, we do not believe that it is necessary to discontinue the C-APCs that include brachytherapy insertion procedures and single session SRS procedures. We continue to believe that the C-APC policy is appropriately applied to these surgical procedures for the reasons cited when this policy was first adopted and note that the commenters did not provide any empirical evidence to support their claims that the existing C-APC policy does not adequately pay for these procedures. Also, we will continue in CY 2019 to pay separately for the 10 planning and preparation services (HCPCS codes 70551, 70552, 70553, 77011, 77014, 77280, 77285, 77290, 77295, and 77336) adjunctive to the delivery of the SRS treatment using either the Cobalt-60-based or LINAC based technology when furnished to a beneficiary within 1 month of the SRS treatment for CY 2019 (82 FR 59242 and 59243).

    Comment: Several commenters representing stem cell transplant organizations requested that CMS also establish a new C-APC for autologous stem cell transplants for CY 2019. These commenters stated that the C-APC methodology will allow CMS to better capture the costs of additional services, such as laboratory tests, provided with the autologous transplant. The Advisory Panel on Hospital Outpatient Payment (HOP Panel) also recommended that CMS study the appropriateness of creating a comprehensive APC for autologous hematopoietic stem cell transplantation.

    Response: We appreciate these comments and may consider the creation of a C-APC for autologous stem cell transplants for future rulemaking as recommended by the HOP Panel.

    Comment: Two manufacturers of drugs used in ocular procedures requested that CMS discontinue the C-APC payment policy for existing C-APCs that include procedures involving their drugs and instead provide separate payment for the drugs. The manufacturer commenters, as well as several physicians, believed that the C-APC packaging policy, which packages payment for certain drugs that are adjunctive to the primary service, results in underpayment for the drugs.

    Response: We continue to believe that the procedures assigned to the proposed C-APCs, including the procedures involving the drugs used in ocular procedures mentioned by the commenters, are appropriately paid through a comprehensive APC and the costs of drugs (as well as other items or services furnished with the procedures) are reflected in hospital billing, and therefore the rates that are established for the ocular procedures. As stated in the CY 2017 OPPS/ASC final rule with comment period (81 FR 79584), procedures assigned to C-APCs are primary services (mostly major surgical procedures) that are typically the focus of the hospital outpatient stay. In addition, with regard to the packaging of the drugs based on the C-APC policy, as stated in previous rules (78 FR 74868 through 74869 and 74909 and 79 FR 66800), items included in the packaged payment provided with the primary “J1” service include all drugs, biologicals, and radiopharmaceuticals payable under the OPPS, regardless of cost, except those drugs with pass-through payment status.

    After consideration of the public comments we received, we are finalizing the proposed C-APCs for CY 2019. Table 7 below lists the final C-APCs for CY 2019. All C-APCs are displayed in Addendum J to this final rule with comment period (which is available via the internet on the CMS website). Addendum J to this final rule with comment period also contains all of the data related to the C-APC payment policy methodology, including the list of complexity adjustments and other information for CY 2019.

    BILLING CODE 4120-01-P ER21NO18.009 ER21NO18.010 ER21NO18.011 BILLING CODE 4120-01-C (3) Exclusion of Procedures Assigned to New Technology APCs From the C-APC Policy

    Services that are assigned to New Technology APCs are typically new procedures that do not have sufficient claims history to establish an accurate payment for the procedures. Beginning in CY 2002, we retain services within New Technology APC groups until we gather sufficient claims data to enable us to assign the service to an appropriate clinical APC. This policy allows us to move a service from a New Technology APC in less than 2 years if sufficient data are available. It also allows us to retain a service in a New Technology APC for more than 2 years if sufficient data upon which to base a decision for reassignment have not been collected (82 FR 59277).

    The C-APC payment policy packages payment for adjunctive and secondary items, services, and procedures into the most costly primary procedure under the OPPS at the claim level. When a procedure assigned to a New Technology APC is included on the claim with a primary procedure, identified by OPPS status indicator “J1”, payment for the new technology service is typically packaged into the payment for the primary procedure. Because the new technology service is not separately paid in this scenario, the overall number of single claims available to determine an appropriate clinical APC for the new service is reduced. This is contrary to the objective of the New Technology APC payment policy, which is to gather sufficient claims data to enable us to assign the service to an appropriate clinical APC.

    For example, for CY 2017, there were seven claims generated for HCPCS code 0100T (Placement of a subconjunctival retinal prosthesis receiver and pulse generator, and implantation of intraocular retinal electrode array, with vitrectomy), which involves the use of the Argus® II Retinal Prosthesis System. However, several of these claims were not available for ratesetting because HCPCS code 0100T was reported with a “J1” procedure and, therefore, payment was packaged into the associated C-APC payment. If these services had been separately paid under the OPPS, there would be at least two additional single claims available for ratesetting. As mentioned previously, the purpose of the new technology APC policy is to ensure that there are sufficient claims data for new services, which is particularly important for services with a low volume such as procedures described by HCPCS code 0100T. Another concern is the costs reported for the claims when payment is not packaged for a new technology procedure may not be representative of all of the services included on a claim that is generated, which may also affect our ability to assign the new service to the most appropriate clinical APC.

    To address this issue and help ensure that there is sufficient claims data for services assigned to New Technology APCs, in the CY 2019 OPPS/ASC proposed rule (83 FR 37063), we proposed to exclude payment for any procedure that is assigned to a New Technology APC (APCs 1491 through 1599 and APCs 1901 through 1908) from being packaged when included on a claim with a “J1” service assigned to a C-APC. This issue is also addressed in section III.C.3.b. of the proposed rule and this final rule with comment period.

    Comment: Numerous commenters supported the proposal.

    Response: We appreciate the commenters' support.

    After consideration of the public comments we received, we are finalizing the proposal, without modification, to exclude payment for any procedure that is assigned to a New Technology APC (APCs 1491 through 1599 and APCs 1901 through 1908) from being packaged when included on a claim with a “J1” service assigned to a C-APC.

    c. Calculation of Composite APC Criteria-Based Costs

    As discussed in the CY 2008 OPPS/ASC final rule with comment period (72 FR 66613), we believe it is important that the OPPS enhance incentives for hospitals to provide necessary, high quality care as efficiently as possible. For CY 2008, we developed composite APCs to provide a single payment for groups of services that are typically performed together during a single clinical encounter and that result in the provision of a complete service. Combining payment for multiple, independent services into a single OPPS payment in this way enables hospitals to manage their resources with maximum flexibility by monitoring and adjusting the volume and efficiency of services themselves. An additional advantage to the composite APC model is that we can use data from correctly coded multiple procedure claims to calculate payment rates for the specified combinations of services, rather than relying upon single procedure claims which may be low in volume and/or incorrectly coded. Under the OPPS, we currently have composite policies for mental health services and multiple imaging services. (We note that, in the CY 2018 OPPS/ASC final rule with comment period, we finalized a policy to delete the composite APC 8001 (LDR Prostate Brachytherapy Composite) for CY 2018 and subsequent years.) We refer readers to the CY 2008 OPPS/ASC final rule with comment period (72 FR 66611 through 66614 and 66650 through 66652) for a full discussion of the development of the composite APC methodology, and the CY 2012 OPPS/ASC final rule with comment period (76 FR 74163) and the CY 2018 OPPS/ASC final rule with comment period (82 FR 59241 through 59242 and 59246 through 52950) for more recent background.

    In the CY 2019 OPPS/ASC proposed rule (83 FR 37064), for CY 2019 and subsequent years, we proposed to continue our composite APC payment policies for mental health services and multiple imaging services, as discussed below. In addition, as discussed in section II.A.2.b.(3) and II.A.2.c. of the CY 2018 OPPS/ASC proposed rule and final rule with comment period (82 FR 33577 through 33578 and 59241 through 59242 and 59246, respectively), in the CY 2019 proposed rule, we proposed to continue to assign CPT code 55875 (Transperineal placement of needles or catheters into prostate for interstitial radioelement application, with or without cystoscopy) to status indicator “J1” and to continue to assign the services described by CPT code 55875 to C-APC 5375 (Level 5 Urology and Related Services) for CY 2019. We did not receive any public comments on these proposed assignments. Therefore, for CY 2019, we are continuing to assign CPT code 55875 to status indicator “J1” and to assign services described by CPT code 55875 to C-APC 5375.

    (1) Mental Health Services Composite APC

    In the CY 2019 OPPS/ASC proposed rule (83 FR 37064), we proposed to continue our longstanding policy of limiting the aggregate payment for specified less resource-intensive mental health services furnished on the same date to the payment for a day of partial hospitalization services provided by a hospital, which we consider to be the most resource intensive of all outpatient mental health services. We refer readers to the April 7, 2000 OPPS final rule with comment period (65 FR 18452 through 18455) for the initial discussion of this longstanding policy and the CY 2012 OPPS/ASC final rule with comment period (76 FR 74168) for more recent background.

    In the CY 2017 OPPS/ASC final rule with comment period (81 FR 79588 through 79589), we finalized a policy to combine the existing Level 1 and Level 2 hospital-based PHP APCs into a single hospital-based PHP APC, and thereby discontinue APCs 5861 (Level 1 Partial Hospitalization (3 services) for Hospital-Based PHPs) and 5862 (Level 2 Partial Hospitalization (4 or more services) for Hospital-Based PHPs) and replace them with APC 5863 (Partial Hospitalization (3 or more services per day)).

    In the CY 2018 OPPS/ASC proposed rule and final rule with comment period (82 FR 33580 through 33581 and 59246 through 59247, respectively), we proposed and finalized the policy for CY 2018 and subsequent years that, when the aggregate payment for specified mental health services provided by one hospital to a single beneficiary on a single date of service, based on the payment rates associated with the APCs for the individual services, exceeds the maximum per diem payment rate for partial hospitalization services provided by a hospital, those specified mental health services will be paid through composite APC 8010 (Mental Health Services Composite). In addition, we set the payment rate for composite APC 8010 for CY 2018 at the same payment rate that will be paid for APC 5863, which is the maximum partial hospitalization per diem payment rate for a hospital, and finalized a policy that the hospital will continue to be paid the payment rate for composite APC 8010. Under this policy, the I/OCE will continue to determine whether to pay for these specified mental health services individually, or to make a single payment at the same payment rate established for APC 5863 for all of the specified mental health services furnished by the hospital on that single date of service. We continue to believe that the costs associated with administering a partial hospitalization program at a hospital represent the most resource intensive of all outpatient mental health services. Therefore, we do not believe that we should pay more for mental health services under the OPPS than the highest partial hospitalization per diem payment rate for hospitals.

    In the CY 2019 OPPS/ASC proposed rule (83 FR 37064), for CY 2019, we proposed that when the aggregate payment for specified mental health services provided by one hospital to a single beneficiary on a single date of service, based on the payment rates associated with the APCs for the individual services, exceeds the maximum per diem payment rate for partial hospitalization services provided by a hospital, those specified mental health services would be paid through composite APC 8010 for CY 2019. In addition, we proposed to set the proposed payment rate for composite APC 8010 at the same payment rate that we proposed for APC 5863, which is the maximum partial hospitalization per diem payment rate for a hospital, and that the hospital continue to be paid the proposed payment rate for composite APC 8010.

    Comment: One commenter supported equalizing payments between the outpatient APC rate and the PHP per diem rate. The commenter also supported the increase in the proposed CY 2019 payment rates from the CY 2018 payment rates.

    Response: We appreciate the commenter's support.

    After consideration of the public comment we received, we are finalizing our CY 2019 proposal, without modification, that when the aggregate payment for specified mental health services provided by one hospital to a single beneficiary on a single date of service, based on the payment rates associated with the APCs for the individual services, exceeds the maximum per diem payment rate for partial hospitalization services provided by a hospital, those specified mental health services will be paid through composite APC 8010 for CY 2019. In addition, we are finalizing our CY 2019 proposal, without modification, to set the payment rate for composite APC 8010 at the same payment rate as APC 5863, which is the maximum partial hospitalization per diem payment rate for a hospital, and that the hospital continue to be paid the payment rate for composite APC 8010.

    (2) Multiple Imaging Composite APCs (APCs 8004, 8005, 8006, 8007, and 8008)

    Effective January 1, 2009, we provide a single payment each time a hospital submits a claim for more than one imaging procedure within an imaging family on the same date of service, in order to reflect and promote the efficiencies hospitals can achieve when performing multiple imaging procedures during a single session (73 FR 41448 through 41450). We utilize three imaging families based on imaging modality for purposes of this methodology: (1) Ultrasound; (2) computed tomography (CT) and computed tomographic angiography (CTA); and (3) magnetic resonance imaging (MRI) and magnetic resonance angiography (MRA). The HCPCS codes subject to the multiple imaging composite policy and their respective families are listed in Table 12 of the CY 2014 OPPS/ASC final rule with comment period (78 FR 74920 through 74924).

    While there are three imaging families, there are five multiple imaging composite APCs due to the statutory requirement under section 1833(t)(2)(G) of the Act that we differentiate payment for OPPS imaging services provided with and without contrast. While the ultrasound procedures included under the policy do not involve contrast, both CT/CTA and MRI/MRA scans can be provided either with or without contrast. The five multiple imaging composite APCs established in CY 2009 are:

    • APC 8004 (Ultrasound Composite);

    • APC 8005 (CT and CTA without Contrast Composite);

    • APC 8006 (CT and CTA with Contrast Composite);

    • APC 8007 (MRI and MRA without Contrast Composite); and

    • APC 8008 (MRI and MRA with Contrast Composite).

    We define the single imaging session for the “with contrast” composite APCs as having at least one or more imaging procedures from the same family performed with contrast on the same date of service. For example, if the hospital performs an MRI without contrast during the same session as at least one other MRI with contrast, the hospital will receive payment based on the payment rate for APC 8008, the “with contrast” composite APC.

    We make a single payment for those imaging procedures that qualify for payment based on the composite APC payment rate, which includes any packaged services furnished on the same date of service. The standard (noncomposite) APC assignments continue to apply for single imaging procedures and multiple imaging procedures performed across families. For a full discussion of the development of the multiple imaging composite APC methodology, we refer readers to the CY 2009 OPPS/ASC final rule with comment period (73 FR 68559 through 68569).

    In the CY 2019 OPPS/ASC proposed rule (83 FR 37065), we proposed, for CY 2019 and subsequent years, to continue to pay for all multiple imaging procedures within an imaging family performed on the same date of service using the multiple imaging composite APC payment methodology. We stated that we continue to believe that this policy would reflect and promote the efficiencies hospitals can achieve when performing multiple imaging procedures during a single session.

    The proposed CY 2019 payment rates for the five multiple imaging composite APCs (APCs 8004, 8005, 8006, 8007, and 8008) were based on proposed geometric mean costs calculated from a partial year of CY 2017 claims available for the CY 2019 OPPS/ASC proposed rule that qualified for composite payment under the current policy (that is, those claims reporting more than one procedure within the same family on a single date of service). To calculate the proposed geometric mean costs, we used the same methodology that we have used to calculate the geometric mean costs for these composite APCs since CY 2014, as described in the CY 2014 OPPS/ASC final rule with comment period (78 FR 74918). The imaging HCPCS codes referred to as “overlap bypass codes” that we removed from the bypass list for purposes of calculating the proposed multiple imaging composite APC geometric mean costs, in accordance with our established methodology as stated in the CY 2014 OPPS/ASC final rule with comment period (78 FR 74918), were identified by asterisks in Addendum N to the CY 2019 OPPS/ASC proposed rule (which is available via the internet on the CMS website) and were discussed in more detail in section II.A.1.b. of the CY 2019 OPPS/ASC proposed rule.

    For the CY 2019 OPPS/ASC proposed rule, we were able to identify approximately 638,902 “single session” claims out of an estimated 1.7 million potential claims for payment through composite APCs from our ratesetting claims data, which represents approximately 37 percent of all eligible claims, to calculate the proposed CY 2019 geometric mean costs for the multiple imaging composite APCs. Table 4 of the CY 2019 OPPS/ASC proposed rule listed the proposed HCPCS codes that would be subject to the multiple imaging composite APC policy and their respective families and approximate composite APC proposed geometric mean costs for CY 2019.

    We did not receive any public comments on these proposals. However, in the CY 2019 OPPS/ASC proposed rule (83 FR 37065), we inadvertently omitted the new CPT codes that will be effective January 1, 2019 from Table 4. We did include these codes in Addendum M to the proposed rule (which was available via the internet on the CMS website). Therefore, new Category I CPT codes that will be effective January 1, 2019 are flagged with comment indicator “NI” in Addendum M to this CY 2019 OPPS/ASC final rule with comment period to indicate that we have assigned the codes an interim APC assignment for CY 2019. We are inviting public comments in this CY 2019 OPPS/ASC final rule with comment period on the interim APC assignments and payment rates for the new codes in Addendum M that will be finalized in the CY 2020 OPPS/ASC final rule with comment period.

    Table 8 below lists the HCPCS codes that will be subject to the multiple imaging composite APC policy and their respective families and approximate composite APC final geometric mean costs for CY 2019.

    BILLING CODE 4120-01-P ER21NO18.012 ER21NO18.013 ER21NO18.014 ER21NO18.015 BILLING CODE 4120-01-C 3. Changes to Packaged Items and Services a. Background and Rationale for Packaging in the OPPS

    Like other prospective payment systems, the OPPS relies on the concept of averaging to establish a payment rate for services. The payment may be more or less than the estimated cost of providing a specific service or a bundle of specific services for a particular patient. The OPPS packages payments for multiple interrelated items and services into a single payment to create incentives for hospitals to furnish services most efficiently and to manage their resources with maximum flexibility. Our packaging policies support our strategic goal of using larger payment bundles in the OPPS to maximize hospitals' incentives to provide care in the most efficient manner. For example, where there are a variety of devices, drugs, items, and supplies that could be used to furnish a service, some of which are more costly than others, packaging encourages hospitals to use the most cost-efficient item that meets the patient's needs, rather than to routinely use a more expensive item, which often occurs if separate payment is provided for the item.

    Packaging also encourages hospitals to effectively negotiate with manufacturers and suppliers to reduce the purchase price of items and services or to explore alternative group purchasing arrangements, thereby encouraging the most economical health care delivery. Similarly, packaging encourages hospitals to establish protocols that ensure that necessary services are furnished, while scrutinizing the services ordered by practitioners to maximize the efficient use of hospital resources. Packaging payments into larger payment bundles promotes the predictability and accuracy of payment for services over time. Finally, packaging may reduce the importance of refining service-specific payment because packaged payments include costs associated with higher cost cases requiring many ancillary items and services and lower cost cases requiring fewer ancillary items and services. Because packaging encourages efficiency and is an essential component of a prospective payment system, packaging payments for items and services that are typically integral, ancillary, supportive, dependent, or adjunctive to a primary service has been a fundamental part of the OPPS since its implementation in August 2000. For an extensive discussion of the history and background of the OPPS packaging policy, we refer readers to the CY 2000 OPPS final rule (65 FR 18434), the CY 2008 OPPS/ASC final rule with comment period (72 FR 66580), the CY 2014 OPPS/ASC final rule with comment period (78 FR 74925), the CY 2015 OPPS/ASC final rule with comment period (79 FR 66817), the CY 2016 OPPS/ASC final rule with comment period (80 FR 70343), the CY 2017 OPPS/ASC final rule with comment period (81 FR 79592), and the CY 2018 OPPS/ASC final rule with comment period (82 FR 59250). As we continue to develop larger payment groups that more broadly reflect services provided in an encounter or episode of care, we have expanded the OPPS packaging policies. Most, but not necessarily all, categories of items and services currently packaged in the OPPS are listed in 42 CFR 419.2(b). Our overarching goal is to make payments for all services under the OPPS more consistent with those of a prospective payment system and less like those of a per-service fee schedule, which pays separately for each coded item. As a part of this effort, we have continued to examine the payment for items and services provided under the OPPS to determine which OPPS services can be packaged to further achieve the objective of advancing the OPPS toward a more prospective payment system.

    For CY 2019, we examined the items and services currently provided under the OPPS, reviewing categories of integral, ancillary, supportive, dependent, or adjunctive items and services for which we believe payment would be appropriately packaged into payment of the primary service that they support. Specifically, we examined the HCPCS code definitions (including CPT code descriptors) and outpatient hospital billing patterns to determine whether there were categories of codes for which packaging would be appropriate according to existing OPPS packaging policies or a logical expansion of those existing OPPS packaging policies. In the CY 2019 OPPS/ASC proposed rule (83 37067 through 37071), for CY 2019, we proposed to conditionally package the costs of selected newly identified ancillary services into payment with a primary service where we believe that the packaged item or service is integral, ancillary, supportive, dependent, or adjunctive to the provision of care that was reported by the primary service HCPCS code. Below we discuss the proposed and finalized changes to the packaging policies beginning in CY 2019.

    b. CY 2019 Packaging Policy for Non-Opioid Pain Management Treatments

    In the CY 2018 OPPS/ASC proposed rule (82 FR 33588), within the framework of existing packaging categories, such as drugs that function as supplies in a surgical procedure or diagnostic test or procedure, we requested stakeholder feedback on common clinical scenarios involving currently packaged items and services described by HCPCS codes that stakeholders believe should not be packaged under the OPPS. We also expressed interest in stakeholder feedback on common clinical scenarios involving separately payable HCPCS codes for which payment would be most appropriately packaged under the OPPS. Commenters expressed a variety of views on packaging under the OPPS. In the CY 2018 OPPS/ASC final rule with comment period, we summarized the comments received in response to our request (82 FR 59255). The comments ranged from requests to unpackage most items and services that are either conditionally or unconditionally packaged under the OPPS, including drugs and devices, to specific requests for separate payment for a specific drug or device. We stated in the CY 2018 OPPS/ASC final rule with comment period that CMS would continue to explore and evaluate packaging policies under the OPPS and consider these policies in future rulemaking.

    In addition to stakeholder feedback regarding OPPS packaging policies, the President's Commission on Combating Drug Addiction and the Opioid Crisis (the Commission) recently recommended that CMS examine payment policies for certain drugs that function as a supply, specifically non-opioid pain management treatments. The Commission was established in 2017 to study ways to combat and treat drug abuse, addiction, and the opioid crisis. The Commission's report 3 included a recommendation for CMS to “. . . review and modify ratesetting policies that discourage the use of non-opioid treatments for pain, such as certain bundled payments that make alternative treatment options cost prohibitive for hospitals and doctors, particularly those options for treating immediate postsurgical pain. . . .” 4 With respect to the packaging policy, the Commission's report states that “. . . the current CMS payment policy for ‘supplies’ related to surgical procedures creates unintended incentives to prescribe opioid medications to patients for postsurgical pain instead of administering non-opioid pain medications. Under current policies, CMS provides one all-inclusive bundled payment to hospitals for all ‘surgical supplies,’ which includes hospital-administered drug products intended to manage patients' postsurgical pain. This policy results in the hospitals receiving the same fixed fee from Medicare whether the surgeon administers a non-opioid medication or not.” 5 HHS also presented an Opioid Strategy in April 2017 6 that aims in part to support cutting-edge research and advance the practice of pain management. On October 26, 2017, the opioid crisis was declared a national public health emergency under Federal law 7 and this determination was renewed on April 20, 2018.8

    3 President's Commission on Combating Drug Addiction and the Opioid Crisis, Report (2017). Available at: https://www.whitehouse.gov/sites/whitehouse.gov/files/images/Final_Report_Draft_11-1-2017.pdf.

    4 Ibid, at page 57, Recommendation 19.

    5 Ibid.

    6 Available at: https://www.hhs.gov/about/leadership/secretary/speeches/2017-speeches/secretary-price-announces-hhs-strategy-for-fighting-opioid-crisis/index.html.

    7 Available at: https://www.hhs.gov/about/news/2017/10/26/hhs-acting-secretary-declares-public-health-emergency-address-national-opioid-crisis.html.

    8 Available at: https://www.phe.gov/emergency/news/healthactions/phe/Pages/default.aspx.

    As discussed in the CY 2019 OPPS/ASC proposed rule (83 FR 37068 through 37071), in response to stakeholder comments on the CY 2018 OPPS/ASC proposed rule and in light of the recommendations regarding payment policies for certain drugs, we recently evaluated the impact of our packaging policy for drugs that function as a supply when used in a surgical procedure on the utilization of these drugs in both the hospital outpatient department and the ASC setting. Currently, as noted above, drugs that function as a supply are packaged under the OPPS and the ASC payment system, regardless of the costs of the drugs. The costs associated with packaged drugs that function as a supply are included in the ratesetting methodology for the surgical procedures with which they are billed and the payment rate for the associated procedure reflects the costs of the packaged drugs and other packaged items and services to the extent they are billed with the procedure. In our evaluation, we used currently available data to analyze the utilization patterns associated with specific drugs that function as a supply over a 5-year time period (CYs 2013 through 2017) to determine whether this packaging policy has reduced the use of these drugs. If the packaging policy discouraged the use of drugs that function as a supply or impeded access to these products, we would expect to see a significant decline in utilization of these drugs over time, although we note that a decline in utilization could also reflect other factors, such as the availability of alternative products. We did not observe significant declines in the total number of units used in the hospital outpatient department for a majority of the drugs included in our analysis.

    In fact, under the OPPS, we observed the opposite effect for several drugs that function as a supply, including Exparel (HCPCS code C9290). Exparel is a liposome injection of bupivacaine, an amide local anesthetic, indicated for single-dose infiltration into the surgical site to produce postsurgical analgesia. In 2011, Exparel was approved by the FDA for administration into the postsurgical site to provide postsurgical analgesia.9 Exparel had pass-through payment status from CYs 2012 through 2014 and was separately paid under both the OPPS and the ASC payment system during this 3-year period. Beginning in CY 2015, Exparel was packaged as a surgical supply under both the OPPS and the ASC payment system. Exparel is currently the only non-opioid pain management drug that is packaged as a drug that functions as a supply when used in a surgical procedure under the OPPS and the ASC payment system.

    9 Available at: https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022496s000lbl.pdf.

    From CYs 2013 through 2017, there was an overall increase in the OPPS Medicare utilization of Exparel of approximately 229 percent (from 2.3 million units to 7.7 million units) during this 5-year time period. The total number of claims reporting Exparel increased by 222 percent (from 10,609 claims to 34,183 claims) over this time period. This increase in utilization continued, even after the 3-year drug pass-through payment period ended for this product in 2014, with 18 percent overall growth in the total number of units used from CYs 2015 through 2017 (from 6.5 million units to 7.7 million units). The number of claims reporting Exparel increased by 21 percent during this time period (from 28,166 claims to 34,183 claims).

    Thus, we have not found evidence to support the notion that the OPPS packaging policy has had an unintended consequence of discouraging the use of non-opioid treatment for postsurgical pain management in the hospital outpatient department. Therefore, based on this data analysis, we stated in the CY 2019 OPPS/ASC proposed rule that we did not believe that changes were necessary under the OPPS for the packaged drug policy for drugs that function as a surgical supply when used in a surgical procedure in this setting at this time.

    In terms of Exparel in particular, we have received several requests to pay separately for the drug rather than packaging payment for it as a surgical supply. In the CY 2015 OPPS/ASC final rule with comment period (79 FR 66874 and 66875), in response to comments from stakeholders requesting separate payment for Exparel, we stated that we considered Exparel to be a drug that functions as a surgical supply because it is indicated for the alleviation of postoperative pain. We also stated that we consider all items related to the surgical outcome and provided during the hospital stay in which the surgery is performed, including postsurgical pain management drugs, to be part of the surgery for purposes of our drug and biological surgical supply packaging policy. In the CY 2018 OPPS/ASC final rule with comment period (82 FR 59345), we reiterated our position with regard to payment for Exparel, stating that we believed that payment for this drug is appropriately packaged with the primary surgical procedure. In addition, we have reviewed recently available literature with respect to Exparel, including a briefing document 10 submitted for the FDA Advisory Committee Meeting held February 14-15, 2018, by the manufacturer of Exparel that notes that “. . . Bupivacaine, the active pharmaceutical ingredient in Exparel, is a local anesthetic that has been used for infiltration/field block and peripheral nerve block for decades” and that “since its approval, Exparel has been used extensively, with an estimated 3.5 million patient exposures in the US.” 11 On April 6, 2018, the FDA approved Exparel's new indication for use as an interscalene brachial plexus nerve block to produce postsurgical regional analgesia.12 Therefore, we also stated in the CY 2019 OPPS/ASC proposed rule that, based on our review of currently available OPPS Medicare claims data and public information from the manufacturer of the drug, we did not believe that the OPPS packaging policy had discouraged the use of Exparel for either of the drug's indications. Accordingly, we continue to believe it is appropriate to package payment for Exparel as we do with other postsurgical pain management drugs when it is furnished in a hospital outpatient department. However, we invited public comments on whether separate payment would nonetheless further incentivize appropriate use of Exparel in the hospital outpatient setting and peer-reviewed evidence that such increased utilization would lead to a decrease in opioid use and addiction among Medicare beneficiaries.

    10 Food and Drug Administration, Meeting of the Anesthetic and Analgesic Drug Products Advisory Committee Briefing Document (2018). Available at: https://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/AnestheticAndAnalgesicDrugProductsAdvisoryCommittee/UCM596314.pdf.

    11 Ibid, page 9.

    12 Available at: https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022496s009lbledt.pdf.

    Comment: Several commenters, including hospital associations, medical specialty societies, and drug manufacturers, requested that CMS pay separately for Exparel in the hospital outpatient setting. Some of these commenters noted that Exparel is used more frequently in this setting and the use of non-opioid pain management treatments should also be encouraged in the hospital outpatient department. The manufacturer of Exparel, Pacira Pharmaceuticals, stated that since the drug became packaged in 2015, utilization of the drug in the hospital outpatient department has remained flat while the opioid crisis has continued to worsen. The manufacturer suggested that, to address the opioid crisis among Medicare beneficiaries, CMS should promote “increased penetration of non-opioid therapies in the HOPD setting—or in other words, higher rates of usage of non-opioid treatments for the same number of surgical procedures.”

    Response: While these commenters advocated paying separately for Exparel in the hospital outpatient setting, we do not believe that there is sufficient evidence that non-opioid pain management drugs should be paid separately in the hospital outpatient setting at this time. The commenters submitted some peer-reviewed studies, discussed in further detail below, that showed that the use of Exparel could lead to a decrease in opioid use in the treatment of acute post-surgical pain among Medicare beneficiaries. However, the commenters did not provide evidence that the OPPS packaging policy for Exparel (or other non-opioid drugs) creates a barrier to use of Exparel in the hospital setting. Further, while we received some public comments suggesting that, as a result of using Exparel in the OPPS setting, providers may prescribe fewer opioids for Medicare beneficiaries, we do not believe that the OPPS payment policy presents a barrier to use of Exparel or affects the likelihood that providers may prescribe fewer opioids in the HOPD setting. Several drugs are packaged under the OPPS and payment for such drugs is included in the payment for the associated primary procedure. We were not persuaded by the anecdotal information supplied by commenters suggesting that some providers avoid use of non-opioid alternatives (including Exparel) solely because of the OPPS packaged payment policy. Finally, while the rate of growth for Exparel use in the HOPD setting has declined over recent years, such trend might be expected because absolute utilization tends to be smaller in the initial period when a drug first comes available on the U.S. market. Additionally, we observed that the total number of providers billing for Exparel under the OPPS has increased each year from 2012 to 2017. Therefore, we do not believe that the current OPPS payment methodology for Exparel and other non-opioid pain management drugs presents a barrier to their use.

    In addition, higher use in the hospital outpatient setting not only supports the notion that the packaged payment for Exparel is not causing an access to care issue, but also that the payment rate for primary procedures in the HOPD using Exparel adequately reflects the cost of the drug. That is, because Exparel is commonly used and billed under the OPPS, the APC rates for the primary procedures reflect such utilization. Therefore, the higher utilization in the OPPS setting should mitigate the need for separate payment. We remind readers that the OPPS is a prospective payment system, not a cost-based system and, by design, is based on a system of averages whereby payment for certain cases may exceed the costs incurred, while for others, it may not. As stated earlier in this section, the OPPS packages payments for multiple interrelated items and services into a single payment to create incentives for hospitals to furnish services most efficiently and to manage their resources with maximum flexibility. Our packaging policies support our strategic goal of using larger payment bundles in the OPPS to maximize hospitals' incentives to provide care in the most efficient manner. We will continue to analyze the evidence and monitor utilization of non-opioid alternatives in the OPD and ASC settings for potential future rulemaking.

    We also stated in the proposed rule that, although we found increases in utilization for Exparel when it is paid under the OPPS, we did notice different effects on Exparel utilization when examining the effects of our packaging policy under the ASC payment system. In particular, during the same 5-year period of CYs 2013 through 2017, the total number of units of Exparel used in the ASC setting decreased by 25 percent (from 98,160 total units to 73,595 total units) and the total number of claims reporting Exparel decreased by 16 percent (from 527 claims to 441 claims). In the ASC setting, after the pass-through payment period ended for Exparel at the end of CY 2014, the total number of units of Exparel used decreased by 70 percent (from 244,757 units to 73,595 units) between CYs 2015 and 2017. The total number of claims reporting Exparel also decreased during this time period by 62 percent (from 1,190 claims to 441 claims). However, there was an increase of 238 percent (from 98,160 total units to 331,348 total units) in the total number of units of Exparel used in the ASC setting during the time period of CYs 2013 and 2014 when the drug received pass-through payments, indicating that the payment rate of ASP+6 percent for Exparel may have had an impact on its usage in the ASC setting. The total number of claims reporting Exparel also increased during this time period from 527 total claims to 1,540 total claims, an increase of 192 percent.

    While several variables may contribute to this difference in utilization and claims reporting between the hospital outpatient department and the ASC setting, one potential explanation is that, in comparison to hospital outpatient departments, ASCs tend to provide specialized care and a more limited range of services. Also, ASCs are paid, in aggregate, approximately 55 percent of the OPPS rate. Therefore, fluctuations in payment rates for specific services may impact these providers more acutely than hospital outpatient departments, and therefore, ASCs may be less likely to choose to furnish non-opioid postsurgical pain management treatments, which are typically more expensive than opioids, as a result. Another possible contributing factor is that ASCs do not typically report packaged items and services and, accordingly, our analysis may be undercounting the number of Exparel units utilized in the ASC setting.

    In light of the results of our evaluation of packaging policies under the OPPS and the ASC payment system, which showed decreased utilization for certain drugs that function as a supply in the ASC setting in comparison to the hospital outpatient department setting, as well as the Commission's recommendation to examine payment policies for non-opioid pain management drugs that function as a supply, we stated in the proposed rule that we believe a change in how we pay for non-opioid pain management drugs that function as surgical supplies may be warranted. In particular, we stated that we believe it may be appropriate to pay separately for evidence-based non-opioid pain management drugs that function as a supply in a surgical procedure in the ASC setting to address the decreased utilization of these drugs and to encourage use of these types of drugs rather than prescription opioids. Therefore, we proposed in section XII.D.3. of the CY 2019 OPPS/ASC proposed rule to unpackage and pay separately for the cost of non-opioid pain management drugs that function as surgical supplies when they are furnished in the ASC setting for CY 2019 (83 FR 37065).

    We have stated previously (82 FR 59250) that our packaging policies are designed to support our strategic goal of using larger payment bundles in the OPPS to maximize hospitals' incentives to provide care in the most efficient manner. The packaging policies established under the OPPS also typically apply when services are provided in the ASC setting, and the policies have the same strategic goals in both settings. While the CY 2019 proposal is a departure from our current ASC packaging policy for drugs (specifically, non-opioid pain management drugs) that function as a supply when used in a surgical procedure, we stated in the proposed rule that we believe that the proposed change will incentivize the use of non-opioid pain management drugs and is responsive to the Commission's recommendation to examine payment policies for non-opioid pain management drugs that function as a supply, with the overall goal of combating the current opioid addiction crisis. As previously noted, a discussion of the CY 2019 proposal for payment of non-opioid pain management drugs in the ASC setting was presented in further detail in section XII.D.3. of the proposed rule, and we refer readers to section XII.D.3. of this CY 2019 OPPS/ASC final rule with comment period for further discussion of the final policy for CY 2019. We also stated in the CY 2019 OPPS/ASC proposed rule that we were interested in peer-reviewed evidence that demonstrates that use of non-opioid alternatives, such as Exparel, furnished in the outpatient setting actually does lead to a decrease in prescription opioid use and addiction and invited public comments containing evidence that demonstrate whether and how such non-opioid alternatives affect prescription opioid use during or after an outpatient visit or procedure.

    Comment: Several commenters, including individual stakeholders, hospital and physician groups, national medical associations, drug rehabilitation specialists, device manufacturers, and groups representing the pharmaceutical industry, supported the proposal to unpackage and pay separately for the cost of non-opioid pain management drugs that function as surgical supplies, such as Exparel, in the ASC setting for CY 2019. These commenters believed that packaged payment for non-opioid alternatives presents a barrier to care and that separate payment for non-opioid pain management drugs would be an appropriate response to the opioid drug abuse epidemic.

    Other commenters, including MedPAC, did not support this proposal and stated that the policy was counter to the OPPS packaging policies created to encourage efficiencies and could set a precedent for unpackaging services. One commenter stated that Exparel is more costly, but not more effective than bupivacaine, a less costly non-opioid alternative. Other commenters expressed concerns that the proposal may have the unintended consequence of limiting access to opioid prescriptions for beneficiaries for whom an opioid prescription would be appropriate. The commenters noted that some non-opioid pain management treatments may pose other risks for patients and patient safety.

    Response: This comment and other comments specific to packaging under the ASC payment system are addressed in section XII.D.3. of this final rule with comment period.

    In addition, as noted in section XII.D.3. of the proposed rule (83 FR 37065 through 37068), we sought comments on whether the proposed policy would decrease the dose, duration, and/or number of opioid prescriptions beneficiaries receive during and following an outpatient visit or procedure (especially for beneficiaries at high-risk for opioid addiction) as well as whether there are other non-opioid pain management alternatives that would have similar effects and may warrant separate payment. For example, we stated we were interested in identifying whether single post-surgical analgesic injections, such as Exparel, or other non-opioid drugs or devices that are used during an outpatient visit or procedure are associated with decreased opioid prescriptions and/or reduced cases of associated opioid addiction following such an outpatient visit or procedure. We also requested comments that provide evidence (such as published peer-reviewed literature) we could use to determine whether these products help to deter or avoid prescription opioid use and addiction as well as evidence that the current packaged payment for such non-opioid alternatives presents a barrier to access to care and, therefore, warrants separate payment under either or both the OPPS and the ASC payment system. We stated that any evidence demonstrating the reduction or avoidance of prescription opioids would be the criterion we use to determine whether separate payment is warranted for CY 2019. We also stated that if evidence changes over time, we would consider whether a reexamination of any policy adopted in the final rule would be necessary.

    Comment: With regard to whether the proposed policy would decrease the dose, duration, and/or number of opioid prescriptions beneficiaries receive during and following an outpatient visit or procedure and supportive evidence of these reductions, one commenter, the manufacturer of Exparel, submitted studies that claimed that the use of Exparel by Medicare patients undergoing total knee replacement procedures reduced prescription opioid consumption by 90 percent compared to the control group measured at 48 hours post-surgery.13 The manufacturer submitted additional studies claiming statistically significant reductions in opioid use with the use of Exparel for various surgeries, including laparotomy, shoulder replacement, and breast reconstruction.

    13 Michael A. Mont et al., Local Infiltration Analgesia With Liposomal Bupivacaine Improves Pain Scores and Reduces Opioid Use After Total Knee Arthroplasty: Results of a Randomized Controlled Trial. J. of Arthroplasty (2018).

    Several commenters identified other non-opioid pain management drugs that they believe decrease the dose, duration, and/or number of opioid prescriptions beneficiaries receive during and following an outpatient visit or procedure (especially for beneficiaries at high-risk for opioid addiction) and may warrant separate payment for CY 2019. Commenters from the makers of other packaged non-opioid pain management drugs, including a non-opioid intrathecal infusion drug indicated for the management of severe chronic pain, submitted supporting studies which claimed that the drug reduced opioid use in patients with chronic pain.

    Several commenters, from hospitals, hospital associations, and clinical specialty organizations, requested separate payment for IV acetaminophen, IV ibuprofen, and epidural steroid injections. In addition, one commenter, the manufacturer of a non-opioid analgesic containing bupivacaine hcl not currently approved by FDA, requested clarification regarding whether the proposal would also apply to this drug once it receives FDA approval. Several commenters requested separate payment for a drug that treats postoperative pain after cataract surgery, currently has drug pass-through payment status, and therefore is not packaged under the OPPS or the ASC payment system. The commenters requested that CMS explicitly state that this drug will also be paid for separately in the ASC setting after pass-through payment status ends for the drug in 2020. Lastly, one commenter, the makers of a diagnostic drug that is not a non-opioid, requested separate payment.

    Response: We appreciate these comments. After reviewing the studies provided by the commenters, we continue to believe the separate payment is appropriate for Exparel in the ASC setting. At this time, we have not found compelling evidence for other non-opioid pain management drugs described above to warrant separate payment under the ASC payment system for CY 2019. Also, with regard to the requests for CMS to confirm that the proposed policy would also apply in the future to certain non-opioid pain management drugs, we reiterate that the proposed policy is for CY 2019 and is applicable to non-opioid pain management drugs that are currently packaged under the policy for drugs that function as a surgical supply when used in the ASC setting, which currently is only Exparel. To the extent that other non-opioid pain management drugs become available on the U.S. market in 2019, this policy would also apply to those drugs.

    As noted above, we stated in the proposed rule that we were interested in comments regarding other non-opioid treatments besides Exparel that might be affected by our OPPS and ASC packaging policies, including alternative, non-opioid pain management treatments, such as devices or therapy services that are not currently separable payable. We stated that we were specifically interested in comments regarding whether CMS should consider separate payment for items and services for which payment is currently packaged under the OPPS and the ASC payment system that are effective non-opioid alternatives as well as evidence that demonstrates such items and services lead to a decrease in prescription opioid use and/or addiction during or after an outpatient visit or procedure in order to determine whether separate payment may be warranted. As previously stated, we intended to examine the evidence submitted to determine whether to adopt a final policy in this final rule with comment period that incentivizes use of non-opioid alternative items and services that have evidence to demonstrate an associated decrease in prescription opioid use and/or addiction following an outpatient visit or procedure. We stated that some examples of evidence that may be relevant could include an indication on the product's FDA label or studies published in peer-reviewed literature that such product aids in the management of acute or chronic pain and is an evidence-based non-opioid alternative for acute and/or chronic pain management. We indicated in the proposed rule that we also were interested in evidence relating to products that have shown clinical improvement over other alternatives, such as a device that has been shown to provide a substantial clinical benefit over the standard of care for pain management. We stated that this could include, for example, spinal cord stimulators used to treat chronic pain, such as the devices described by HCPCS codes C1822 (Generator, neurostimulator (implantable), high frequency, with rechargeable battery and charging system), C1820 (Generator, neurostimulator (implantable), with rechargeable battery and charging system), and C1767 (Generator, neurostimulator (implantable), nonrechargeable) which are primarily assigned to APCs 5463 and 5464 (Levels 3 and 4 Neurostimulator and Related Procedures) with proposed CY 2019 payment rates of $18,718 and $27,662, respectively, that have received pass-through payment status as well as other similar devices.

    Currently, all devices are packaged under the OPPS and the ASC payment system unless they have pass-through payment status. However, we stated in the proposed rule that, in light of the Commission's recommendation to review and modify ratesetting policies that discourage the use of non-opioid treatments for pain, we were interested in comments from stakeholders regarding whether, similar to the goals of the proposed payment policy for non-opioid pain management drugs that function as a supply when used in a surgical procedure, a policy of providing separate payment (rather than packaged payment) for these products, indefinitely or for a specified period of time, would also incentivize the use of alternative non-opioid pain management treatments and improve access to non-opioid alternatives, particularly for innovative and low-volume items and services.

    We also stated that we were interested in comments regarding whether we should provide separate payment for non-opioid pain management treatments or products using a mechanism such as an equitable payment adjustment under our authority at section 1833(t)(2)(E) of the Act, which states that the Secretary shall establish, in a budget neutral manner, other adjustments as determined to be necessary to ensure equitable payments. For example, we stated in the proposed rule that we were considering whether an equitable payment adjustment in the form of an add-on payment for APCs that use a non-opioid pain management drug, device, or service would be appropriate. We indicated that, to the extent that commenters provided evidence to support this approach, we would consider adopting a final policy in this final rule with comment period, which could include regulatory changes that would allow for an exception to the packaging of certain nonpass-through devices that represent non-opioid alternatives for acute or chronic pain that have evidence to demonstrate that their use leads to a decrease in opioid prescriptions and/or opioid abuse or misuse during or after an outpatient visit or procedure to effectuate such change.

    Comment: Several commenters, manufacturers of spinal cord stimulators (SCS), stated that separate payment was also warranted for these devices because they provide an alternative treatment option to opioids for patients with chronic, leg, or back pain. One of the manufacturers of a high-frequency SCS device provided supporting studies which claimed that patients treated with their device reported a statistically significant average decrease in opioid use compared to the control group.14 This commenter also submitted data that showed a decline in the mean daily dosage of opioid medication taken and that fewer patients were relying on opioids at all to manage their pain when they used the manufacturer's device.15 Another commenter, a SCS manufacturer, stated that there are few peer-reviewed studies that evaluate opioid elimination and/or reduction following SCS and that there is a need for more population-based research with opioid reduction or elimination as a study endpoint. However, this commenter believed that current studies suggest that opioid use may be reduced following SCS therapy.

    14 Kapural L, Yu C, Doust MW, Gliner BE, Vallejo R, Sitzman BT, Amirdelfan K, Morgan DM, Brown LL, Yearwood TL, Bundschu R, Burton AW, Yang T, Benyamin R, Burgher AH. Novel 10-kHz high-frequency therapy (HF10 therapy) is superior to traditional low-frequency spinal cord stimulation for the treatment of chronic back and leg pain: The SENZA-RCT randomized controlled trial, Anesthesiology. 2015 Oct;123(4):851-60.

    15 Al-Kaisy A, Van Buyten JP, Smet I, Palmisani S, Pang D, Smith T. Sustained effectiveness of 10 kHz high-frequency spinal cord stimulation for patients with chronic, low back pain: 24-month results of a prospective multicenter study. Pain Med. 2014 Mar; 15(3):347-54.

    Commenters representing various stakeholders requested separate payments for various non-opioid pain management treatments, such as continuous nerve blocks (including a disposable elastomeric pump that delivers non-opioid local anesthetic to a surgical site or nerve), cooled thermal radiofrequency ablation for nonsurgical, chronic nerve pain, and physical therapy services. These commenters, including national hospital associations, recommended that while “certainly not a solution to the opioid epidemic, unpackaging appropriate non-opioid therapies, like Exparel, is a low-cost tactic that could change long-standing practice patterns without major negative consequences.” This same commenter suggested that Medicare consider separate payment for Polar ice devices for postoperative pain relief after knee procedures. The commenter also noted that therapeutic massage, topically applied THC oil, acupuncture, and dry needling procedures are very effective therapies for relief of both postoperative pain and long-term and chronic pain.

    Commenters suggested various mechanisms through which separate payment or a higher-paying APC assignment for the primary service could be made. Commenters offered reports, studies, and anecdotal evidence of varying degrees to support why the items or services about which they were writing offered an alternative to or reduction of the need for opioid prescriptions.

    Response: We appreciate the detailed responses to our solicitation for comments on this topic. We plan to take these comments and suggestions into consideration for future rulemaking. We agree that providing incentives to avoid and/or reduce opioid prescriptions may be one of several strategies for addressing the opioid epidemic. To the extent that the items and services mentioned by the commenters are effective alternatives to opioid prescriptions, we encourage providers to use them when medically necessary. We note that some of the items and services mentioned by commenters are not covered by Medicare, and we do not intend to establish payment for noncovered items and services. We look forward to working with stakeholders as we further consider suggested refinements to the OPPS and the ASC payment system that will encourage use of medically necessary items and services that have demonstrated efficacy in decreasing opioid prescriptions and/or opioid abuse or misuse during or after an outpatient visit or procedure.

    Comment: One commenter suggested that CMS provide separate payment for HCPCS code A4306 (Disposable drug delivery system, flow rate of less than 50 ml per hour) in the hospital outpatient department setting and the ASC setting following a post-surgery procedure. This commenter explained that if a patient needs additional pain relief 3 to 5 days post-surgery, a facility cannot receive payment for providing a replacement disposable drug delivery system (HCPCS code A4306) unless the entire continuous nerve block procedure is performed. This commenter believed that CMS should allow for HCPCS code A4306 to be dispensed to the patient as long as the patient is in pain, the pump is empty, and the delivery catheters are still in place. The commenter believed that the drug delivery system should incentivize the continued use of non-opioid alternatives when needed. In addition, several commenters stated that CMS should use an equitable payment adjustment under our authority at section 1833(t)(2)(E) of the Act to establish add-on payments for packaged devices used as non-opioid alternatives.

    Response: We appreciate the commenter's suggestion. We acknowledge that use of these items may help in the reduction of opioid use postoperatively. However, we note that packaged payment of such an item does not prevent the use of these items. We remind readers that payment for packaged items is included in the payment for the primary service. We share the commenter's concern about the need to reduce opioid use and will take the commenter's suggestion into consideration for future rulemaking.

    After reviewing the non-opioid pain management alternatives suggested by the commenters as well as the studies and other data provided to support the request for separate payment, we have not determined that separate payment is warranted at this time for any of the non-opioid pain management alternatives discussed above.

    We also invited public comments on whether a reorganization of the APC structure for procedures involving non-opioid products or establishing more granular APC groupings for specific procedure and device combinations to ensure that the payment rate for such services is aligned with the resources associated with procedures involving specific devices would better achieve our goal of incentivizing increased use of non-opioid alternatives, with the aim of reducing opioid use and subsequent addiction. For example, we stated we would consider finalizing a policy to establish new APCs for procedures involving non-opioid pain management packaged items or services if such APCs would better recognize the resources involved in furnishing such items and services and decrease or eliminate the need for prescription opioids. In addition, given the general desire to encourage provider efficiency through creating larger bundles of care and packaging items and services that are integral, ancillary, supportive, dependent, or adjunctive to a primary service, we also invited comments on how such alternative payment structures would continue to balance the goals of incentivizing provider efficiencies with encouraging the use of non-opioid alternatives to pain management.

    Furthermore, because patients may receive opioid prescriptions following receipt of a non-opioid drug or implantation of a device, we stated that we were interested in identifying any cost implications for the patient and the Medicare program caused by this potential change in policy. We also stated that the implications of incentivizing use of non-opioid pain management drugs available for postsurgical acute pain relief during or after an outpatient visit or procedure are of interest. The goal is to encourage appropriate use of such non-opioid alternatives. As previously stated, this comment solicitation is also discussed in section XII.D.3. of this final rule with comment period relating to the ASC payment system.

    Comment: Regarding APC reorganization, one commenter suggested that CMS restructure the two-level Nerve Procedure APCs (5431 and 5432) to provide more payment granularity for the procedures included in the APCs by creating a third level.

    Response: This comment is addressed in section III.D.17. of this final rule with comment period. As stated in that section, we believe that the current two-level APCs for the Nerve Procedures provide an appropriate distinction between the resource costs at each level and provide clinical homogeneity. We will continue to review this APC structure to determine if additional granularity is necessary for this APC family in future rulemaking. In addition, we believe that more analysis of such groupings is necessary before adopting such change.

    In addition, in the proposed rule, we invited the public to submit ideas on regulatory, subregulatory, policy, practice, and procedural changes to help prevent opioid use disorders and improve access to treatment under the Medicare program. We stated that we were interested in identifying barriers that may inhibit access to non-opioid alternatives for pain treatment and management or access to opioid use disorder treatment, including those barriers related to payment methodologies or coverage. In addition, consistent with our “Patients Over Paperwork” Initiative, we stated that we were interested in suggestions to improve existing requirements in order to more effectively address the opioid epidemic.

    Comment: Several commenters addressed payment barriers that may inhibit access to non-opioid pain management treatments previously discussed throughout this section. With regard to barriers related to payment methodologies or coverage, one commenter, a clinical specialty society, suggested that CMS support multi-modal pain management and enhanced recovery after surgery (ERAS) and encourage patient access to certified registered nurse anesthetist (CRNA) pain management. One commenter also suggested that CMS reduce cost-sharing and eliminate the need for prior authorization for non-opioid pain management strategies.

    Response: We appreciate the various, insightful comments we received from stakeholders regarding barriers that may inhibit access to non-opioid alternatives for pain treatment and management in order to more effectively address the opioid epidemic. Many of these comments have been previously addressed throughout this section.

    After consideration of the public comments that we received, we are finalizing the proposed policy, without modification, to unpackage and pay separately at ASP+6 percent for the cost of non-opioid pain management drugs that function as surgical supplies when they are furnished in the ASC setting for CY 2019. We will continue to analyze the issue of access to non-opioid alternatives in the OPD and the ASC settings as we implement section 6082 of the Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act (Pub. L. 115-271 enacted on October 24, 2018. This policy is also discussed in section XII.D.3 of this final rule with comment period.

    4. Calculation of OPPS Scaled Payment Weights

    We established a policy in the CY 2013 OPPS/ASC final rule with comment period (77 FR 68283) of using geometric mean-based APC costs to calculate relative payment weights under the OPPS. In the CY 2018 OPPS/ASC final rule with comment period (82 FR 59255 through 59256), we applied this policy and calculated the relative payment weights for each APC for CY 2018 that were shown in Addenda A and B to that final rule with comment period (which were made available via the internet on the CMS website) using the APC costs discussed in sections II.A.1. and II.A.2. of that final rule with comment period. For CY 2019, as we did for CY 2018, in the CY 2019 OPPS/ASC proposed rule (83 FR 37071), we proposed to continue to apply the policy established in CY 2013 and calculate relative payment weights for each APC for CY 2019 using geometric mean-based APC costs.

    For CY 2012 and CY 2013, outpatient clinic visits were assigned to one of five levels of clinic visit APCs, with APC 0606 representing a mid-level clinic visit. In the CY 2014 OPPS/ASC final rule with comment period (78 FR 75036 through 75043), we finalized a policy that created alphanumeric HCPCS code G0463 (Hospital outpatient clinic visit for assessment and management of a patient), representing any and all clinic visits under the OPPS. HCPCS code G0463 was assigned to APC 0634 (Hospital Clinic Visits). We also finalized a policy to use CY 2012 claims data to develop the CY 2014 OPPS payment rates for HCPCS code G0463 based on the total geometric mean cost of the levels one through five CPT E/M codes for clinic visits previously recognized under the OPPS (CPT codes 99201 through 99205 and 99211 through 99215). In addition, we finalized a policy to no longer recognize a distinction between new and established patient clinic visits.

    For CY 2016, we deleted APC 0634 and reassigned the outpatient clinic visit HCPCS code G0463 to APC 5012 (Level 2 Examinations and Related Services) (80 FR 70372). For CY 2019, as we did for CY 2018, we proposed to continue to standardize all of the relative payment weights to APC 5012. We believe that standardizing relative payment weights to the geometric mean of the APC to which HCPCS code G0463 is assigned maintains consistency in calculating unscaled weights that represent the cost of some of the most frequently provided OPPS services. For CY 2019, as we did for CY 2018, we proposed to assign APC 5012 a relative payment weight of 1.00 and to divide the geometric mean cost of each APC by the geometric mean cost for APC 5012 to derive the unscaled relative payment weight for each APC. The choice of the APC on which to standardize the relative payment weights does not affect payments made under the OPPS because we scale the weights for budget neutrality.

    We did not receive any public comments on our proposal to continue to use the geometric mean cost of APC 5012 to standardize relative payment weights for CY 2019. Therefore, we are finalizing our proposal and assigning APC 5012 the relative payment weight of 1.00, and using the relative payment weight for APC 5012 to derive the unscaled relative payment weight for each APC for CY 2019.

    We note that, in section X.B. of the OPPS/ASC proposed rule (83 FR 37137 through 37138) and of this final rule with comment period, we discuss our CY 2019 proposal and established final policy to control for unnecessary increases in the volume of covered outpatient department services by paying for clinic visits furnished at excepted off-campus provider-based department (PBD) at an amount of 70 percent of the OPPS rate for a clinic visit service in CY 2019, rather than at the standard OPPS rate. While the volume associated with these visits is included in the impact model, and thus used in calculating the weight scalar, the proposal and final policy have only a negligible effect on the scalar. Specifically, under the proposed and final policy, there is no change to the relativity of the OPPS payment weights because the adjustment is made at the payment level rather than in the cost modeling. Further, under our proposed and final policy, the savings that will result from the change in payments for these clinic visits will not be budget neutral. Therefore, the impact of the proposed and final policy will generally not be reflected in the budget neutrality adjustments, whether the adjustment is to the OPPS relative weights or to the OPPS conversion factor. We refer readers to section X.B. of this CY 2019 OPPS/ASC final rule with comment period for further discussion of this final policy.

    Section 1833(t)(9)(B) of the Act requires that APC reclassification and recalibration changes, wage index changes, and other adjustments be made in a budget neutral manner. Budget neutrality ensures that the estimated aggregate weight under the OPPS for CY 2019 is neither greater than nor less than the estimated aggregate weight that would have been made without the changes. To comply with this requirement concerning the APC changes, in the CY 2019 OPPS/ASC proposed rule (83 FR 37071 through 37072), we proposed to compare the estimated aggregate weight using the CY 2018 scaled relative payment weights to the estimated aggregate weight using the proposed CY 2019 unscaled relative payment weights.

    For CY 2018, we multiplied the CY 2018 scaled APC relative payment weight applicable to a service paid under the OPPS by the volume of that service from CY 2017 claims to calculate the total relative payment weight for each service. We then added together the total relative payment weight for each of these services in order to calculate an estimated aggregate weight for the year. For CY 2019, we proposed to apply the same process using the estimated CY 2019 unscaled relative payment weights rather than scaled relative payment weights. We proposed to calculate the weight scalar by dividing the CY 2018 estimated aggregate weight by the unscaled CY 2019 estimated aggregate weight.

    For a detailed discussion of the weight scalar calculation, we refer readers to the OPPS claims accounting document available on the CMS website at: https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/HospitalOutpatientPPS/index.html. Click on the CY 2019 OPPS final rule link and open the claims accounting document link at the bottom of the page.

    We proposed to compare the estimated unscaled relative payment weights in CY 2019 to the estimated total relative payment weights in CY 2018 using CY 2017 claims data, holding all other components of the payment system constant to isolate changes in total weight. Based on this comparison, we proposed to adjust the calculated CY 2019 unscaled relative payment weights for purposes of budget neutrality. We proposed to adjust the estimated CY 2019 unscaled relative payment weights by multiplying them by a proposed weight scalar of 1.4553 to ensure that the proposed CY 2019 relative payment weights are scaled to be budget neutral. The proposed CY 2019 relative payment weights listed in Addenda A and B to the proposed rule (which are available via the internet on the CMS website) were scaled and incorporated the recalibration adjustments discussed in sections II.A.1. and II.A.2. of the proposed rule.

    Section 1833(t)(14) of the Act provides the payment rates for certain SCODs. Section 1833(t)(14)(H) of the Act provides that additional expenditures resulting from this paragraph shall not be taken into account in establishing the conversion factor, weighting, and other adjustment factors for 2004 and 2005 under paragraph (9), but shall be taken into account for subsequent years. Therefore, the cost of those SCODs (as discussed in section V.B.2. of this final rule with comment period) is included in the budget neutrality calculations for the CY 2019 OPPS.

    We did not receive any public comments on the proposed weight scalar calculation. Therefore, we are finalizing our proposal to use the calculation process described in the proposed rule, without modification, for CY 2019. Using updated final rule claims data, we are updating the estimated CY 2019 unscaled relative payment weights by multiplying them by a weight scalar of 1.4574 to ensure that the final CY 2019 relative payment weights are scaled to be budget neutral.

    The final CY 2019 relative payments weights listed in Addenda A and B to this final rule with comment period (which are available via the internet on the CMS website) were scaled and incorporate the recalibration adjustments discussed in sections II.A.1. and II.A.2. of this final rule with comment period.

    B. Conversion Factor Update

    Section 1833(t)(3)(C)(ii) of the Act requires the Secretary to update the conversion factor used to determine the payment rates under the OPPS on an annual basis by applying the OPD fee schedule increase factor. For purposes of section 1833(t)(3)(C)(iv) of the Act, subject to sections 1833(t)(17) and 1833(t)(3)(F) of the Act, the OPD fee schedule increase factor is equal to the hospital inpatient market basket percentage increase applicable to hospital discharges under section 1886(b)(3)(B)(iii) of the Act. As stated in the CY 2019 OPPS/ASC proposed rule, in the FY 2019 IPPS/LTCH PPS proposed rule (83 FR 20381), consistent with current law, based on IHS Global, Inc.'s fourth quarter 2017 forecast of the FY 2019 market basket increase, the proposed FY 2019 IPPS market basket update was 2.8 percent. However, sections 1833(t)(3)(F) and 1833(t)(3)(G)(v) of the Act, as added by section 3401(i) of the Patient Protection and Affordable Care Act of 2010 (Pub. L. 111-148) and as amended by section 10319(g) of that law and further amended by section 1105(e) of the Health Care and Education Reconciliation Act of 2010 (Pub. L. 111-152), provide adjustments to the OPD fee schedule increase factor for CY 2019.

    Specifically, section 1833(t)(3)(F)(i) of the Act requires that, for 2012 and subsequent years, the OPD fee schedule increase factor under subparagraph (C)(iv) be reduced by the productivity adjustment described in section 1886(b)(3)(B)(xi)(II) of the Act. Section 1886(b)(3)(B)(xi)(II) of the Act defines the productivity adjustment as equal to the 10-year moving average of changes in annual economy-wide, private nonfarm business multifactor productivity (MFP) (as projected by the Secretary for the 10-year period ending with the applicable fiscal year, year, cost reporting period, or other annual period) (the “MFP adjustment”). In the FY 2012 IPPS/LTCH PPS final rule (76 FR 51689 through 51692), we finalized our methodology for calculating and applying the MFP adjustment, and then revised this methodology as discussed in the FY 2016 IPPS/LTCH PPS final rule (80 FR 49509). In the CY 2019 OPPS/ASC proposed rule (83 FR 37072), the proposed MFP adjustment for FY 2019 was 0.8 percentage point.

    In the CY 2019 OPPS/ASC proposed rule (83 FR 37072), we proposed that if more recent data became subsequently available after the publication of the proposed rule (for example, a more recent estimate of the market basket increase and the MFP adjustment), we would use such updated data, if appropriate, to determine the CY 2019 market basket update and the MFP adjustment, which are components in calculating the OPD fee schedule in