[Federal Register Volume 83, Number 160 (Friday, August 17, 2018)] [Contents] [Pages III-VII] From the Federal Register Online via the Government Publishing Office [www.gpo.gov] CONTENTS Federal Register / Vol. 83, No. 160 / Friday, August 17, 2018 / Contents [[Page iii]] Agricultural Marketing Service RULES Cotton Board Rules and Regulations: Adjusting Supplemental Assessment on Imports (2018 Amendments), 40931-40945 NOTICES Standards for Grades of Pork Carcasses, 41042-41043 Agriculture Department See Agricultural Marketing Service See Food and Nutrition Service See Forest Service See Rural Business-Cooperative Service See Rural Housing Service See Rural Utilities Service Air Force Department NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 41067-41068 Bureau of Consumer Financial Protection RULES Annual Privacy Notice Requirement Under the Gramm-Leach-Bliley Act (Regulation P), 40945-40959 Centers for Medicare & Medicaid Services RULES Medicare Program: Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals and the Long Term Care Hospital Prospective Payment System and Policy Changes and Fiscal Year 2019 Rates; Quality Reporting Requirements for Specific Providers; Medicare and Medicaid Electronic Health Record (EHR) Incentive Programs (Promoting Interoperability Programs) Requirements for Eligible Hospitals, Critical Access Hospitals, and Eligible Professionals; Medicare Cost Reporting Requirements; and Physician Certification and Recertification of Claims, 41144-41784 PROPOSED RULES Medicare Program: Medicare Shared Savings Program; Accountable Care Organizations Pathways to Success, 41786-41951 NOTICES Medicare and Medicaid Program: Application from DNV G--Healthcare for Continued Approval of its Hospital Accreditation Program, 41073-41075 Children and Families Administration NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 41075-41076 Civil Rights Commission NOTICES Meetings: Delaware Advisory Committee, 41057 District of Columbia Advisory Committee, 41058 Idaho Advisory Committee, 41059 Virginia Advisory Committee, 41057-41058 West Virginia Advisory Committee, 41058-41059 Coast Guard RULES Drawbridge Operations: Columbia River, Portland, OR and Vancouver, WA, 40985-40986 Willamette River at Portland, OR, 40986 PROPOSED RULES Special Local Regulations: Breton Bay, Leonardtown, MD, 41032-41035 Choptank River, Talbot and Dorchester Counties, MD, 41029-41032 NOTICES Lifejacket Approval Harmonization, 41095-41096 Commerce Department See International Trade Administration See National Oceanic and Atmospheric Administration Committee for Purchase From People Who Are Blind or Severely Disabled NOTICES Procurement List; Additions and Deletions, 41064-41065 Consumer Product Safety Commission NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Notification Requirements for Coal and Wood Burning Appliances, 41066-41067 Testing and Recordkeeping Requirements for Carpets and Rugs, 41066 Defense Department See Air Force Department PROPOSED RULES TRICARE: Extended Care Health Option (ECHO) Respite Care, 41026-41029 NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 41068-41071 Education Department NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Federal Family Educational Loan Program--Servicemembers Civil Relief Act, 41071 Servicemembers Civil Relief Act Interest Rate Limitation Request, 41071-41072 Energy Department See Federal Energy Regulatory Commission [[Page iv]] Environmental Protection Agency RULES Air Quality State Implementation Plans; Approvals and Promulgations: California; San Joaquin Valley Unified Air Pollution Control District; Reasonably Available Control Technology Demonstration, 41006-41009 Significant New Use Rules on Certain Chemical Substances, 40986-41006 PROPOSED RULES Air Quality State Implementation Plans; Approvals and Promulgations: Colorado; Motor Vehicle Inspection and Maintenance Program and Associated Revisions, 41035-41039 Significant New Use Rules on Certain Chemical Substances, 41039 NOTICES Environmental Impact Statements; Availability, etc.: Weekly Receipts, 41072-41073 Equal Employment Opportunity Commission NOTICES Meetings; Sunshine Act, 41073 Federal Aviation Administration RULES Airworthiness Directives: ATR-GIE Avions de Transport Regional Airplanes, 40963-40966 Fokker Services B.V. Airplanes, 40959-40961 Rolls-Royce Corporation Engines, 40961-40963 Amendment of Multiple Restricted Area Boundary Descriptions; Florida, 40967-40968 Standard Instrument Approach Procedures, and Takeoff Minimums and Obstacle Departure Procedures, 40968-40973 PROPOSED RULES Amendment of VOR Federal Airways: V-18, V-102, and V-278 in the Vicinity of Guthrie, TX, 41021-41022 NOTICES Exemption Petitions; Summaries: Headquarters Air Force Junior Reserve Officer Training Corps, 41141 Federal Energy Regulatory Commission NOTICES Complaints: North Carolina Electric Membership Corp. v. Duke Energy Progress, LLC, 41072 Federal Highway Administration NOTICES Environmental Impact Statements; Availability, etc.; Rescission, 41141- 41142 Fish and Wildlife Service NOTICES Endangered and Threatened Wildlife and Plants: Draft Recovery Plan for Neosho Mucket, 41100-41101 Food and Drug Administration RULES Medical Devices and Device-Led Combination Products: Voluntary Malfunction Summary Reporting Program for Manufacturers, 40973-40985 PROPOSED RULES Medical Devices: Classification of Accessories Distinct from Other Devices; Proposed List of Accessories Suitable for Class I, 41023-41026 NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Guidance for Industry: Controlled Correspondence Related to Generic Drug Development, 41077-41078 Guidance: Process to Request a Review of Food and Drug Administration's Decision Not to Issue Certain Export Certificates for Devices, 41078-41079 Information Available to Industry: Quality Metrics Site Visit Program for Center for Drug Evaluation and Research and Center for Biologics Evaluation and Research Staff, 41080 Meetings: Science and Regulation of Live Microbiome-Based Products Used to Prevent, Treat, or Cure Diseases in Humans; Public Workshop, 41076-41077 Food and Nutrition Service NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Supplemental Nutrition Assistance Program, Store Applications, 41043-41045 Forest Service NOTICES Environmental Impact Statements; Availability, etc.: Humboldt-Toiyabe National Forest, Clark Counties, Nevada, Lee Canyon, 41045-41046 General Services Administration RULES Civilian Board of Contract Appeals: Rules of Procedure for Contract Disputes Act Cases, 41009-41018 Health and Human Services Department See Centers for Medicare & Medicaid Services See Children and Families Administration See Food and Drug Administration See National Institutes of Health PROPOSED RULES World Trade Center Health Program: Petition 019--Irritable Bowel Syndrome; Finding of Insufficient Evidence, 41039-41041 NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 41080-41081 Homeland Security Department See Coast Guard NOTICES Meetings: Technical Mapping Advisory Council, 41096-41097 Housing and Urban Development Department NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Home Equity Conversion Mortgage Counseling Standardization and Roster, 41097-41098 Indian Community Development Block Grant, 41098-41099 [[Page v]] Single Family Mortgage Insurance on Hawaiian Homelands, 41099-41100 Indian Affairs Bureau NOTICES Indian Gaming: Approval of Tribal-State Class III Gaming Compact Amendments in the State of Oklahoma, 41101-41102 Rate Adjustments for Indian Irrigation Projects, 41102-41108 Interior Department See Fish and Wildlife Service See Indian Affairs Bureau See Land Management Bureau Internal Revenue Service PROPOSED RULES Centralized Partnership Audit Regime, 41954-42015 Removal of Temporary Regulations on a Partner's Share of a Partnership Liability for Disguised Sale Purposes; Hearing Cancellation, 41026 International Trade Administration NOTICES Antidumping or Countervailing Duty Investigations, Orders, or Reviews: Carbazole Violet Pigment 23 from India, 41059-41060 Labor Department See Labor Statistics Bureau Labor Statistics Bureau NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 41112-41113 Land Management Bureau NOTICES Environmental Impact Statements; Availability, etc.: Draft Bears Ears National Monument Indian Creek and Shash Jaa Units Monument Management Plans, Utah, 41111-41112 Grand Staircase-Escalante National Monument-Grand Staircase, Kaiparowits, and Escalante Canyon Units and Federal Lands Previously Included in the Monument that are excluded from the Boundaries Draft Resource Management Plans, 41108-41111 National Institutes of Health NOTICES Meetings: Center for Scientific Review, 41093 Draft Report on Carcinogens Monograph on Night Shift Work and Light at Night, 41093-41095 National Institute of Neurological Disorders and Stroke, 41081 Office of Science Policy Recombinant or Synthetic Nucleic Acid Research: Proposed Changes to the Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules, 41082- 41093 Requests for Information: Feedback on the Brain Research through Advancing Innovative Neurotechnologies Initiative, 41081-41082 National Oceanic and Atmospheric Administration RULES Fisheries of the Exclusive Economic Zone off Alaska: Pacific Ocean Perch in the West Yakutat District of the Gulf of Alaska, 41020 Sablefish in the West Yakutat District of the Gulf of Alaska, 41019-41020 Snapper-Grouper Fishery of the South Atlantic: 2018 Commercial Accountability Measure and Closure for the Other Jacks Complex, 41018-41019 NOTICES Meetings: Fisheries of the Gulf of Mexico; Southeast Data, Assessment, and Review, 41063-41064 Mid-Atlantic Fishery Management Council, 41060-41061 North Pacific Fishery Management Council, 41063 Pacific Fishery Management Council, 41061-41062 Permit Applications: Marine Mammals; File No. 22222, 41062-41063 Nuclear Regulatory Commission NOTICES Meetings; Sunshine Act, 41113 Pension Benefit Guaranty Corporation NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Partitions of Eligible Multiemployer Plans, 41113-41114 Postal Regulatory Commission NOTICES New Postal Products, 41114-41115 Rural Business-Cooperative Service NOTICES Rural Development Cooperative Agreement Program, 41046-41056 Rural Housing Service NOTICES Establishment of Maximum Interest Rate, 41056-41057 Rural Development Cooperative Agreement Program, 41046-41056 Rural Utilities Service NOTICES Rural Development Cooperative Agreement Program, 41046-41056 Securities and Exchange Commission NOTICES Self-Regulatory Organizations; Proposed Rule Changes: Cboe BYX Exchange, Inc., 41128-41138 ICE Clear Credit LLC, 41118-41121 MIAX PEARL, LLC, 41126-41128 Nasdaq BX, Inc., 41121-41124 Nasdaq ISE, LLC, 41124-41126 New York Stock Exchange LLC, 41117-41118 The Nasdaq Stock Market LLC, 41115-41116 Small Business Administration NOTICES Changes to SBA Secondary Market Program, 41139 Major Disaster Declarations: Hawaii, 41138-41139 [[Page vi]] State Department NOTICES Designation as a Foreign Terrorist Organization: Abu Sayyaf Group (and Other Aliases), 41140 Boko Haram (and Other Aliases), 41140 Designation as a Specially Designated Global Terrorist: Qassim Abdullah Ali Ahmed, aka Qassim al-Muamen, aka Qassim Al Muamen, aka Qassim Abdullah Ali, aka Qassim Abdullah, 41139-41140 Surface Transportation Board NOTICES Meetings: National Grain Car Council, 41140 Tennessee Valley Authority NOTICES Meetings: Regional Energy Resource Council, 41140-41141 Transportation Department See Federal Aviation Administration See Federal Highway Administration Treasury Department See Internal Revenue Service ----------------------------------------------------------------------- Separate Parts In This Issue Part II Health and Human Services Department, Centers for Medicare & Medicaid Services, 41144-41784 Part III Health and Human Services Department, Centers for Medicare & Medicaid Services, 41786-41951 Part IV Treasury Department, Internal Revenue Service, 41954-42015 ----------------------------------------------------------------------- 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. To subscribe to the Federal Register Table of Contents electronic mailing list, go to https://public.govdelivery.com/accounts/USGPOOFR/subscriber/ new, enter your e-mail address, then follow the instructions to join, leave, or manage your subscription. CFR PARTS AFFECTED IN THIS ISSUE __________________________________________________________ A cumulative list of the parts affected this month can be found in the Reader Aids section at the end of this issue. Federal Register / Vol. 83, No. 160 / Friday, August 17, 2018 / Contents Federal Register / Vol. 83, No. 160 / Friday, August 17, 2018 / Contents Federal Register / Vol. 83, No. 160 / Friday, August 17, 2018 / Contents [[Page vii]] 7 CFR 1205.................................................40931 12 CFR 1016.................................................40945 14 CFR 39 (3 documents).......................40959, 40961, 40963 73...................................................40967 97 (2 documents)..............................40968, 40971 Proposed Rules: 71...................................................41021 21 CFR 803..................................................40973 Proposed Rules: 876..................................................41023 878..................................................41023 886..................................................41023 26 CFR Proposed Rules: 1 (2 documents)...............................41026, 41954 301..................................................41954 32 CFR Proposed Rules: 199..................................................41026 33 CFR 117 (2 documents).............................40985, 40986 Proposed Rules: 100 (2 documents).............................41029, 41032 40 CFR 9....................................................40986 52...................................................41006 721..................................................40986 Proposed Rules: 52...................................................41035 721..................................................41039 42 CFR 412..................................................41144 413..................................................41144 424..................................................41144 495..................................................41144 Proposed Rules: 88...................................................41039 414..................................................41786 425..................................................41786 48 CFR 6101.................................................41009 6102.................................................41009 50 CFR 622..................................................41018 679 (2 documents).............................41019, 41020