[Federal Register Volume 86, Number 200 (Wednesday, October 20, 2021)]
[Contents]
[Pages III-VII]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]



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                  CONTENTS
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  Federal Register / Vol. 86, No. 200 / Wednesday, October 20, 2021 / 
Contents  

[[Page iii]]




Agriculture Department
See Food Safety and Inspection Service
See Forest Service


Centers for Medicare & Medicaid Services
RULES
Medicare Program:
    Hospital Inpatient Prospective Payment Systems for Acute Care 
            Hospitals, etc.; Corrections, 58019-58039


Civil Rights Commission
NOTICES
Meetings:
    Kentucky Advisory Committee, 58057
    New Mexico Advisory Committee, 58057-58058
    Texas Advisory Committee, 58056-58057


Coast Guard
NOTICES
Recertification of Cool Inlet Regional Citizens' Advisory Council, 
          58083


Commerce Department
See Foreign-Trade Zones Board
See International Trade Administration
See National Oceanic and Atmospheric Administration


Defense Department
NOTICES
Administrative Suspension of Table Rock Lake Oversight Committee, 
          58062-58063
Charter Amendment:
    Defense Business Board, 58063
Meetings:
    Wage Committee, 58063-58066


Education Department
NOTICES
Agency Information Collection Activities; Proposals, Submissions, and 
          Approvals:
    Consolidated State Performance Report Renewal (Part 1 and Part 2), 
            58066
    Income Based Repayment--Notifications, 58066-58067


Energy Department
See Federal Energy Regulatory Commission
NOTICES
Meetings:
    Environmental Management Site-Specific Advisory Board, Savannah 
            River Site, 58067-58068
    Nuclear Science Advisory Committee, 58067


Environmental Protection Agency
NOTICES
Draft Availability:
    Integrated Risk Information System Toxicological Review of 
            Perfluorobutanoic Acid and Related Compound Ammonium 
            Perfluorobutanoic Acid, 58075-58076
Proposed Stipulated Partial Settlement Agreement, Endangered Species 
          Act Claims, 58074-58075
Receipt of Safe Drinking Water Act Application Submissions for FY21, 
          58076-58079


Farm Credit Administration
PROPOSED RULES
Risk Weighting of High Volatility Commercial Real Estate Exposures, 
          58042


Federal Aviation Administration
NOTICES
COVID-19 Related Relief Concerning Operations at Chicago O'Hare 
          International Airport, John F. Kennedy International Airport, 
          Los Angeles International Airport, et al., for the Winter 
          2021/2022 Scheduling Season, 58134-58141


Federal Communications Commission
RULES
Call Authentication Trust Anchor, 58039-58040


Federal Emergency Management Agency
NOTICES
Agency Information Collection Activities; Proposals, Submissions, and 
          Approvals:
    Fire Management Assistance Grant Program, 58083-58084


Federal Energy Regulatory Commission
NOTICES
Application:
    Public Service Co. of Colorado, 58072
Combined Filings, 58068-58070
Filing:
    Oncor Electric Delivery Co. LLC, 58071
Initial Market-Based Rate Filings Including Requests for Blanket 
          Section 204 Authorizations:
    Route 66 Solar Energy Center, LLC, 58071-58072
Records Governing Off-the-Record Communications, 58070-58071
Request under Blanket Authorization:
    WBI Energy Transmission, Inc., 58073-58074


Federal Maritime Commission
NOTICES
Agreement Filed, 58079


Federal Trade Commission
RULES
Energy Labeling Rule, 57985-57991


Fish and Wildlife Service
NOTICES
Agency Information Collection Activities; Proposals, Submissions, and 
          Approvals:
    Approval Procedures for Nontoxic Shot and Shot Coatings, 58091-
            58092
Permit Applications:
    Endangered Species, 58092-58093
    Foreign Endangered Species, 58089-58091


Food and Drug Administration
RULES
New Animal Drugs:
    Approval of New Animal Drug Applications; Changes of Sponsorship, 
            57992-58016

[[Page iv]]

PROPOSED RULES
Medical Devices:
    Ear, Nose, and Throat Devices; Establishing Over-the-Counter 
            Hearing Aids, 58150-58191
NOTICES
Guidance:
    Regulatory Requirements for Hearing Aid Devices and Personal Sound 
            Amplification Products; Availability, 58192-58193


Food Safety and Inspection Service
NOTICES
Meetings:
    National Advisory Committee on Microbiological Criteria for Foods, 
            58054-58055


Foreign Assets Control Office
RULES
Publication of Venezuela Web General License 7 and Subsequent 
          Iterations, 58016-58018


Foreign-Trade Zones Board
NOTICES
Authorization of Production Activity:
    LUC Urethanes, Inc., Foreign-Trade Zone 265, Conroe, TX, 58058


Forest Service
NOTICES
Charter Reestablishment:
    Black Hills National Forest Advisory Board, 58055-58056


Health and Human Services Department
See Centers for Medicare & Medicaid Services
See Food and Drug Administration
See Health Resources and Services Administration
See National Institutes of Health
PROPOSED RULES
Proposed Repeal of HHS Rules on Guidance, Enforcement, and Adjudication 
          Procedures, 58042-58053


Health Resources and Services Administration
NOTICES
Agency Information Collection Activities; Proposals, Submissions, and 
          Approvals:
    COVID-19 Provider Relief Fund Reporting Activities, 58079-58080


Homeland Security Department
See Coast Guard
See Federal Emergency Management Agency
See U.S. Customs and Border Protection
NOTICES
Privacy Act; Systems of Records, 58084-58088


Housing and Urban Development Department
NOTICES
Agency Information Collection Activities; Proposals, Submissions, and 
          Approvals:
    Single Family Premium Collection Subsystem--Periodic, 58088-58089


Interior Department
See Fish and Wildlife Service
See Land Management Bureau


Internal Revenue Service
NOTICES
Meetings:
    Taxpayer Advocacy Panel Taxpayer Assistance Center Improvements 
            Project Committee, 58147
    Taxpayer Advocacy Panel's Special Projects Committee, 58147
    Taxpayer Advocacy Panel's Tax Forms and Publications Project 
            Committee; Correction, 58146-58147


International Trade Administration
NOTICES
Meetings:
    United States Travel and Tourism Advisory Board, 58058


International Trade Commission
NOTICES
Investigations; Determinations, Modifications, and Rulings, etc.:
    Certain Foodservice Equipment and Components Thereof; Termination, 
            58097-58098
    Certain Laparoscopic Surgical Staplers, Reload Cartridges, and 
            Components Thereof, 58100-58101
    Certain Vaporizer Cartridges and Components Thereof, 58099-58100
    Polyethylene Terephthalate Resin from Canada, China, India, and 
            Oman, 58101-58102
    Porcelain-on-Steel Cooking Ware from China, 58097
    Utility Scale Wind Towers from India and Malaysia, 58098-58099


Justice Department
NOTICES
Proposed Consent Decree:
    Clean Water Act and Oil Pollution Act, 58103
    Resource Conservation and Recovery Act and Other Statutes, 58102-
            58103


Labor Department
See Occupational Safety and Health Administration
NOTICES
Agency Information Collection Activities; Proposals, Submissions, and 
          Approvals:
    United States-Mexico-Canada Agreement Web-based Hotline, 58103-
            58104


Land Management Bureau
NOTICES
Agency Information Collection Activities; Proposals, Submissions, and 
          Approvals:
    Surveys and Focus Groups To Support Outcomes-Focused Management 
            (Recreation Survey and Focus Groups), 58094
Annual Statutorily Required Increase in Filing Fee:
    Processing Fiscal Year 2022; Applications for Permit to Drill, 
            58095-58096
Segregation of Public Land:
    Rough Hat Clark County Solar Project, Clark County, NV, 58096-58097
    Rough Hat Nye County Solar Project, Nye County, NV, 58094-58095
Use of Truck-Mounted Coriolis Meters; Correction, 58093


National Archives and Records Administration
NOTICES
Records Schedules; Availability, 58106-58107
Solicitation of Nominations:
    Freedom of Information Act Advisory Committee, 58105-58106

[[Page v]]




National Endowment for the Humanities
NOTICES
Meetings:
    Humanities Panel, 58107-58108


National Foundation on the Arts and the Humanities
See National Endowment for the Humanities


National Highway Traffic Safety Administration
NOTICES
Agency Information Collection Activities; Proposals, Submissions, and 
          Approvals:
    State Data Transfer for Vehicle Crash Information, 58141-58145


National Institutes of Health
NOTICES
Agency Information Collection Activities; Proposals, Submissions, and 
          Approvals:
    Collection of Customer Service, Demographic, and Smoking/Tobacco 
            Use Information from the National Cancer Institute's Cancer 
            Information Service, 58082-58083
Meetings:
    Center for Scientific Review, 58081-58082
    National Heart, Lung, and Blood Institute, 58080-58081


National Labor Relations Board
NOTICES
Appointments of Individuals to Serve as Members of Performance Review 
          Boards, 58108


National Oceanic and Atmospheric Administration
RULES
Fisheries of the Exclusive Economic Zone off Alaska:
    Pollock in Statistical Area 610 in the Gulf of Alaska, 58040-58041
NOTICES
Meetings:
    Caribbean Fishery Management Council, 58061
    Fisheries of the Gulf of Mexico and South Atlantic; Southeast Data, 
            Assessment, and Review, 58061-58062
    Fisheries of the South Atlantic; South Atlantic Fishery Management 
            Council, 58059
    Fisheries of the South Atlantic; Southeast Data, Assessment, and 
            Review, 58060-58061
    North Pacific Fishery Management Council, 58058-58059
    Pacific Fishery Management Council, 58059-58060, 58062
    South Atlantic Fishery Management Council, 58060


National Science Foundation
NOTICES
Antarctic Conservation Act Permits, 58109


Occupational Safety and Health Administration
NOTICES
Agency Information Collection Activities; Proposals, Submissions, and 
          Approvals:
    On-Site Consultation Agreements, 58104-58105


Presidential Documents
PROCLAMATIONS
Special Observances:
    National Character Counts Week (Proc. 10290), 58199-58200
    National Forest Products Week (Proc. 10291), 58201-58202
    National Peace Officers' Memorial Service (Proc. 10289), 58195-
            58197


Securities and Exchange Commission
NOTICES
Filing and Order:
    Approving and Declaring Effective an Amended Plan for the 
            Allocation of Regulatory Responsibilities Between the 
            Financial Industry Regulatory Authority, Inc. and 
            Investors' Exchange LLC, 58110-58116
Self-Regulatory Organizations; Proposed Rule Changes:
    Cboe BZX Exchange, Inc., 58118
    Cboe Exchange, Inc., 58118-58121
    Investors Exchange, LLC, 58125-58127
    Miami International Securities Exchange, LLC, MIAX Emerald, LLC, 
            and MIAX PEARL, LLC, 58124-58125
    MIAX PEARL, LLC, 58130-58133
    Nasdaq BX, Inc., 58116-58118
    Nasdaq ISE, LLC, 58121-58124
    Nasdaq PHLX, LLC, 58128-58130
    New York Stock Exchange, LLC, NYSE American, LLC, NYSE Arca, Inc., 
            et al., 58130
    New York Stock Exchange, LLC; NYSE American, LLC; NYSE Arca, Inc.; 
            et al., 58109-58110, 58116


Small Business Administration
NOTICES
Disaster Declaration:
    Georgia, 58133
Major Disaster Declaration:
    New Jersey, 58133


State Department
NOTICES
Culturally Significant Objects Imported for Exhibition:
    Revealing Krishna: Journey to Cambodia's Sacred Mountain, 58133-
            58134
Designations as Foreign Terrorist Organizations:
    Liberation Tigers of Tamil Eelam; Review, 58134
Determination under the Department of State, Foreign Operations, and 
          Related Programs Appropriations Act, 2020, 58134


Transportation Department
See Federal Aviation Administration
See National Highway Traffic Safety Administration
PROPOSED RULES
Petition for Rulemaking:
    Airport Concession Disadvantaged Business Enterprise Program, 58053
NOTICES
Senior Executive Service Performance Review Boards Membership, 58145-
          58146


Treasury Department
See Foreign Assets Control Office
See Internal Revenue Service


U.S. Customs and Border Protection
RULES
List of User Fee Airports:
    Removal of One Airport, 57991-57992

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Separate Parts In This Issue
Part II
Health and Human Services Department, Food and Drug Administration, 
          58150-58193

[[Page vi]]

Part III
Presidential Documents, 58195-58197, 58199-58202

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Reader Aids

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online resources, finding aids, and notice of recently enacted public laws.

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      CFR PARTS AFFECTED IN THIS ISSUE
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 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. 86, No. 200 / Wednesday, October 20, 2021 / 
Contents  

  Federal Register / Vol. 86, No. 200 / Wednesday, October 20, 2021 / 
Contents  

  Federal Register / Vol. 86, No. 200 / Wednesday, October 20, 2021 / 
Contents  

[[Page vii]]



                           3 CFR
Proclamations:
10289................................................58197
10290................................................58199
10291................................................58201

                          12 CFR
Proposed Rules:
628..................................................58042

                          16 CFR
305..................................................57985

                          19 CFR
122..................................................57991

                          21 CFR
510..................................................57992
516..................................................57992
520..................................................57992
522..................................................57992
526..................................................57992
556..................................................57992
558..................................................57992
Proposed Rules:
800..................................................58150
801..................................................58150
808..................................................58150
874..................................................58150

                          31 CFR
591..................................................58016

                          42 CFR
412..................................................58019
413..................................................58019
425..................................................58019
455..................................................58019
495..................................................58019

                          45 CFR
Proposed Rules:
1....................................................58042

                          47 CFR
64...................................................58039

                          49 CFR
Proposed Rules:
23...................................................58053

                          50 CFR
679..................................................58040