[Federal Register Volume 82, Number 243 (Wednesday, December 20, 2017)]
[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. 82, No. 243 / Wednesday, December 20, 2017 / 
Contents  

[[Page iii]]




Agricultural Marketing Service
RULES
Rules of Practice and Procedures to Formulate or Amend a Marketing 
          Agreement or a Marketing Order, or Certain Research and 
          Promotion Orders; Correction, 60281


Agriculture Department
See Agricultural Marketing Service


Census Bureau
NOTICES
Agency Information Collection Activities; Proposals, Submissions, and 
          Approvals:
    Survey of Residential Building or Zoning Permit Systems, 60369


Centers for Disease Control and Prevention
NOTICES
Meetings:
    Disease, Disability, and Injury Prevention and Control Special 
            Emphasis Panel, 60402


Coast Guard
RULES
Drawbridge Operations:
    Quantuck Canal, Westhampton Beach, NY, 60316-60318
    Sacramento River, Sacramento, CA, 60316
    San Leandro Bay, between Alameda and Bay Farm Island, CA, 60315-
            60316
Quarterly Listings:
    Safety Zones, Security Zones, Special Local Regulations, Drawbridge 
            Operation Regulations and Regulated Navigation Areas; 2016, 
            60312-60315
Safety Zones:
    Spa Creek, Annapolis, MD, 60318-60320
PROPOSED RULES
Safety Zones:
    Pacific Ocean, Kilauea Lava Flow Ocean Entry on Southeast Side of 
            Island of Hawaii, HI, 60341-60348
NOTICES
Removal of Conditions of Entry for Certain Vessels Arriving to the 
          United States from Two Port Facilities:
    Cote d'Ivoire, 60409-60410


Commerce Department
See Census Bureau
See Foreign-Trade Zones Board
See Industry and Security Bureau
See International Trade Administration
See National Institute of Standards and Technology
See National Oceanic and Atmospheric Administration


Commodity Futures Trading Commission
PROPOSED RULES
Retail Commodity Transactions Involving Virtual Currency, 60335-60341


Comptroller of the Currency
NOTICES
Agency Information Collection Activities; Proposals, Submissions, and 
          Approvals:
    Debt Cancellation Contracts and Debt Suspension Agreements, 60468-
            60470


Education Department
NOTICES
Requests for Information:
    Obtaining Input from Rural Schools and Local Educational Agencies, 
            60382-60383


Energy Department
See Energy Information Administration
See Federal Energy Regulatory Commission
NOTICES
Agency Information Collection Activities; Proposals, Submissions, and 
          Approvals:
    Energy Efficiency and Conservation Block Grant Financing Programs, 
            60384
Self-Certifications:
    Coal Capability Under the Powerplant and Industrial Fuel Use Act, 
            60383-60384


Energy Information Administration
NOTICES
Agency Information Collection Activities; Proposals, Submissions, and 
          Approvals, 60384-60385


Environmental Protection Agency
PROPOSED RULES
Air Quality State Implementation Plans; Approvals and Promulgations:
    California; San Diego County Air Pollution Control District, 60348-
            60350
NOTICES
Agency Information Collection Activities; Proposals, Submissions, and 
          Approvals, 60396-60397
Environmental Assessments; Availability, etc.:
    Deepwater Horizon Oil Spill Louisiana Trustee Implementation Group 
            Draft Restoration Plan and Environmental Assessment 
            2: Provide and Enhance Recreational Opportunities, 
            60397-60398


Federal Accounting Standards Advisory Board
NOTICES
Requests for Comments:
    Proposed Statement of Federal Financial Accounting Standards, 
            Classified Activities, 60399


Federal Aviation Administration
RULES
Airworthiness Directives:
    Agusta S.p.A. Helicopters, 60298-60300
    Airbus Helicopters (Previously Eurocopter France), 60292-60295
    The Boeing Company Airplanes, 60300-60302
    The Enstrom Helicopter Corporation Helicopters, 60295-60297
Change to Automatic Dependent Surveillance Broadcast Services, 60302-
          60303
NOTICES
Release of Deed Restrictions:
    Yellowstone Airport, West Yellowstone, MT, 60467-60468

[[Page iv]]




Federal Communications Commission
PROPOSED RULES
Authorizing Permissive Use of the ``Next Generation'' Broadcast 
          Television Standard, 60350-60355


Federal Election Commission
NOTICES
Filing Dates:
    Arizona Special Election in the 8th Congressional District, 60400-
            60401
    Michigan Special Election in the 13th Congressional District, 
            60399-60400


Federal Energy Regulatory Commission
NOTICES
Applications:
    Duke Energy Carolinas, LLC, 60392
    Flambeau Hydro, LLC, 60394-60396
    Mad River Power Associates LP, 60385-60386
Combined Filings, 60389-60393
Declaratory Orders; Petitions:
    Blue Racer NGL Pipelines, LLC, 60394
Environmental Assessments; Availability, etc.:
    Gulf South Pipeline Company, LP; Westlake Expansion Project, 60393-
            60394
Hydroelectric Applications:
    City of Radford, 60386-60387
    Idaho Power Co., 60387-60388
Institution of Section 206 Proceedings:
    Carroll County Energy, LLC, 60394
Petitions for Enforcement:
    Gregory R. and Beverly F. Swecker v. Midland Power Cooperative, 
            Central Iowa Power Cooperative, 60388-60389
Records Governing Off-the-Record Communications, 60391-60392
Requests for Waivers:
    Empire Pipeline, Inc., 60386


Federal Maritime Commission
NOTICES
Agreements Filed, 60401


Federal Motor Carrier Safety Administration
RULES
Hours of Service of Drivers of Commercial Motor Vehicles:
    Electronic Logging Devices; Limited 90-Day Waiver for the 
            Transportation of Agricultural Commodities, 60323-60325
PROPOSED RULES
Hours of Service of Drivers of Commercial Motor Vehicles:
    Transportation of Agricultural Commodities, 60360-60362


Federal Railroad Administration
PROPOSED RULES
Training, Qualification, and Oversight for Safety-Related Railroad 
          Employees, 60355-60360


Federal Reserve System
RULES
Regulation A: Extensions of Credit by Federal Reserve Banks, 60281-
          60282
Regulation D: Reserve Requirements of Depository Institutions, 60282-
          60283
NOTICES
Changes in Bank Control:
    Acquisitions of Shares of a Bank or Bank Holding Company, 60401-
            60402


Federal Trade Commission
PROPOSED RULES
Test Procedures and Labeling Standards for Recycled Oil, 60334-60335


Fish and Wildlife Service
PROPOSED RULES
Endangered and Threatened Species:
    90-Day Findings for Five Species, 60362-60363
NOTICES
Endangered Species Recovery Permit Applications, 60414-60415
Environmental Assessments; Availability, etc.:
    Draft Habitat Conservation Plan for the Desert Tortoise and Mohave 
            Ground Squirrel; Hinkley Groundwater Remediation Project; 
            San Bernardino County, CA, 60416-60417
Permit Applications:
    Foreign Endangered and Threatened Species, 60412-60414


Food and Drug Administration
RULES
Medical Devices:
    General Hospital and Personal Use Devices; Classification of the 
            Image Processing Device for Estimation of External Blood 
            Loss, 60306-60308
Safety and Effectiveness of Health Care Antiseptics; Topical 
          Antimicrobial Drug Products for Over-the-Counter Human Use, 
          60474-60503
NOTICES
Guidance:
    Clarification of Orphan Designation of Drugs and Biologics for 
            Pediatric Subpopulations of Common Diseases, 60402-60403
    Drug Products Labeled as Homeopathic, 60403-60405


Foreign-Trade Zones Board
NOTICES
Proposed Production Activities:
    AFE, Inc., Foreign-Trade Zone 41, Milwaukee, WI, 60369-60370


Health and Human Services Department
See Centers for Disease Control and Prevention
See Food and Drug Administration
See National Institutes of Health
NOTICES
Agency Information Collection Activities; Proposals, Submissions, and 
          Approvals:
    Generic Clearance for the Collection of Qualitative Feedback on 
            Agency Service Delivery, 60405-60406


Homeland Security Department
See Coast Guard


Housing and Urban Development Department
NOTICES
Agency Information Collection Activities; Proposals, Submissions, and 
          Approvals:
    Consolidated Discretionary Grant Programs Solicitations (Funding 
            Opportunities) Templates and Forms, 60410-60412


Industry and Security Bureau
RULES
Certain Entities to the Entity List; Additions:
    Russian Sanctions, 60304-60306

[[Page v]]




Interior Department
See Fish and Wildlife Service
See Land Management Bureau


International Trade Administration
NOTICES
Antidumping or Countervailing Duty Investigations, Orders, or Reviews:
    Certain Crystalline Silicon Photovoltaic Products from Taiwan, 
            60370-60373


International Trade Commission
NOTICES
Investigations; Determinations, Modifications, and Rulings, etc.:
    Certain Color Intraoral Scanners and Related Hardware and Software, 
            60418-60419
    Stainless Steel Butt-Weld Pipe Fittings from Italy, Malaysia, and 
            the Philippines, 60419


Justice Department
NOTICES
Proposed Consent Decrees:
    CERCLA, 60419-60420


Land Management Bureau
RULES
Final Supplementary Rules:
    Guffey Gorge in Park County, CO, 60320-60323
NOTICES
Realty Actions:
    Proposed Non-Competitive (Direct) Sale of Public Land in Santa 
            Barbara County, CA, 60417-60418


National Credit Union Administration
RULES
Agency Reorganization, 60290-60292
Emergency Mergers--Chartering and Field of Membership, 60283-60290


National Institute of Standards and Technology
NOTICES
Accurate Fluorescence Measurements Consortium, 60373-60374


National Institutes of Health
NOTICES
Agency Information Collection Activities; Proposals, Submissions, and 
          Approvals:
    Division of Cancer Epidemiology and Genetics Fellowship Program and 
            Summer Student Applications, 60407-60408
Exclusive Patent Licenses:
    Development of an Anti-CD30 Chimeric Antigen Receptor for the 
            Treatment of Human Cancer, 60406-60407
Government-Owned Inventions; Availability for Licensing, 60408-60409
Meetings:
    National Institute of Neurological Disorders and Stroke, 60407


National Oceanic and Atmospheric Administration
RULES
Fisheries of the Exclusive Economic Zone off Alaska:
    Inseason Adjustment to the 2018 Bering Sea and Aleutian Islands 
            Pollock, Atka Mackerel, and Pacific cod Total Allowable 
            Catch Amounts, 60329-60333
    Inseason Adjustment to the 2018 Gulf of Alaska Pollock and Pacific 
            cod Total Allowable Catch Amounts, 60327-60329
    Reallocation of Atka Mackerel in the Bering Sea and Aleutian 
            Islands Management Area, 60325-60326
PROPOSED RULES
Pacific Island Fisheries:
    2017 Hawaii Kona Crab Annual Catch Limit and Accountability 
            Measure, 60363
NOTICES
Environmental Assessments; Availability, etc.:
    Deepwater Horizon Oil Spill Louisiana Trustee Implementation Group 
            Draft Strategic Restoration Plan and Environmental 
            Assessment 3: Restoration of Wetlands, Coastal and 
            Nearshore Habitats in the Barataria Basin, LA, 60377-60379
    Proposed New Space Lease for the Geophysical Fluid Dynamics 
            Laboratory in Princeton, NJ, 60382
Fisheries of the Exclusive Economic Zone off Alaska:
    North Pacific Halibut and Sablefish Individual Fishing Quota Cost 
            Recovery Programs, 60379-60382
Meetings:
    Fisheries of the South Atlantic; South Atlantic Fishery Management 
            Council, 60376
Permits:
    Marine Mammals, 60374-60376


National Science Foundation
NOTICES
Antarctic Conservation Act Permits, 60420


Nuclear Regulatory Commission
NOTICES
Agency Information Collection Activities; Proposals, Submissions, and 
          Approvals:
    Registration Certificate--In Vitro Testing With Byproduct Material 
            Under General License, 60422-60423
    Request for Approval of Official Foreign Travel, 60423-60424
License Transfers:
    AREVA, Inc.; Richland, WA, 60420-60422


Pension Benefit Guaranty Corporation
RULES
Allocation of Assets in Single-Employer Plans:
    Valuation of Benefits and Assets; Expected Retirement Age, 60308-
            60309


Postal Service
NOTICES
Product Changes:
    Priority Mail Express Negotiated Service Agreement, 60424
    Priority Mail Negotiated Service Agreement, 60424


Securities and Exchange Commission
NOTICES
Applications:
    Ausdal Financial Partners, Inc. and Ausdal Unit Investment Trust, 
            60426-60429
    Consulting Group Capital Markets Funds and Consulting Group 
            Advisory Services LLC, 60463-60464
Self-Regulatory Organizations; Proposed Rule Changes:
    Cboe BZX Exchange, Inc., 60443-60451
    Cboe EDGX Exchange, Inc., 60424-60426
    Municipal Securities Rulemaking Board, 60433-60439
    Nasdaq GEMX, LLC, 60431-60432, 60439-60442
    Nasdaq ISE, LLC, 60453-60458

[[Page vi]]

    Nasdaq MRX, LLC, 60460-60462
    Nasdaq PHLX LLC, 60458-60460
    New York Stock Exchange LLC, 60442, 60451-60453
    NYSE Arca, Inc., 60455
    The Nasdaq Stock Market LLC, 60429-60430


Small Business Administration
NOTICES
Major Disaster Declarations:
    Montana, 60464


State Department
NOTICES
Agency Information Collection Activities; Proposals, Submissions, and 
          Approvals:
    Training/Internship Placement Plan, 60466
Presidential Permits:
    North Dakota, 60464-60466


Surface Transportation Board
NOTICES
Abandonment Exemptions:
    CSX Transportation, Inc. in Greenbrier County, WV, 60466-60467


Transportation Department
See Federal Aviation Administration
See Federal Motor Carrier Safety Administration
See Federal Railroad Administration


Treasury Department
See Comptroller of the Currency
See United States Mint


United States Mint
RULES
Exchange of Coin, 60309-60312


Veterans Affairs Department
NOTICES
Meetings:
    Advisory Committee on the Readjustment of Veterans, 60470
Publication of the Date on Which All Amounts Deposited in the Veterans 
          Choice Fund Will Be Exhausted, 60470-60471

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Separate Parts In This Issue
Part II
Health and Human Services Department, Food and Drug Administration, 
          60474-60503

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Reader Aids

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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. 82, No. 243 / Wednesday, December 20, 2017 / 
Contents  

  Federal Register / Vol. 82, No. 243 / Wednesday, December 20, 2017 / 
Contents  

  Federal Register / Vol. 82, No. 243 / Wednesday, December 20, 2017 / 
Contents  

[[Page vii]]



                           7 CFR
900..................................................60281
1200.................................................60281

                          12 CFR
201..................................................60281
204..................................................60282
701 (2 documents).............................60283, 60290
705..................................................60290
708a.................................................60290
708b.................................................60290
790..................................................60290

                          14 CFR
39 (4 documents)................60292, 60295, 60298, 60300
91...................................................60302

                          15 CFR
744..................................................60304

                          16 CFR
Proposed Rules:
311..................................................60334

                          17 CFR
Proposed Rules:
1....................................................60335

                          21 CFR
310..................................................60473
880..................................................60306

                          29 CFR
4044.................................................60308

                          31 CFR
100..................................................60309

                          33 CFR
100 (2 documents).............................60312, 60314
117 (5 documents)...............60312, 60314, 60315, 60316
147 (2 documents).............................60312, 60314
165 (3 documents)......................60312, 60314, 60318
Proposed Rules:
165..................................................60341

                          40 CFR
Proposed Rules:
52...................................................60348

                          43 CFR
8360.................................................60320

                          47 CFR
Proposed Rules:
15...................................................60350
73...................................................60350
74...................................................60350
76...................................................60350

                          49 CFR
395..................................................60323
Proposed Rules:
243..................................................60355
395..................................................60360

                          50 CFR
679 (3 documents)......................60325, 60327, 60329
Proposed Rules:
17...................................................60362
665..................................................60366