[Federal Register Volume 80, Number 228 (Friday, November 27, 2015)]
[Contents]
[Pages III-VIII]
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. 80, No. 228 / Friday, November 27, 2015 / 
Contents  

[[Page iii]]




Agriculture Department
See Food and Nutrition Service
See National Agricultural Statistics Service


Army Department
NOTICES
Agency Information Collection Activities; Proposals, Submissions, and 
          Approvals, 74091


Bonneville Power Administration
NOTICES
Agency Information Collection Activities; Proposals, Submissions, and 
          Approvals:
    Badge Replacement Request Form, 74098-74099


Bureau of Consumer Financial Protection
RULES
Appraisals for Higher-Priced Mortgage Loans Exemption Threshold, 73943-
          73945
Consumer Lending, 73945-73947
Truth in Lending, 73947-73949


Centers for Disease Control and Prevention
NOTICES
Agency Information Collection Activities; Proposals, Submissions, and 
          Approvals, 74106-74111
Requests for Nominations:
    Board of Scientific Counselors, National Institute for Occupational 
            Safety and Health, 74111-74112
    Board of Scientific Counselors, Office of Infectious Diseases, 
            74112


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 Policy Changes and Fiscal Year 2016 Rates; 
            etc., 73998-73999
NOTICES
Agency Information Collection Activities; Proposals, Submissions, and 
          Approvals, 74112-74113


Commerce Department
See National Oceanic and Atmospheric Administration
See National Technical Information Service
See National Telecommunications and Information Administration


Committee for Purchase From People Who Are Blind or Severely Disabled
NOTICES
Procurement List; Additions and Deletions, 74087-74088


Comptroller of the Currency
RULES
Appraisals for Higher-Priced Mortgage Loans Exemption Threshold, 73943-
          73945


Consumer Product Safety Commission
NOTICES
Settlement Agreements and Orders:
    Philips Lighting North America Corp., 74088-74091


Defense Department
See Army Department
See Navy Department
NOTICES
Agency Information Collection Activities; Proposals, Submissions, and 
          Approvals:
    Freight Classification Description, 74105-74106
Arms Sales, 74092-74098
Meetings:
    National Commission on the Future of the Army, 74091-74092


Education Department
RULES
Program Integrity Issues, 73991-73995


Employment and Training Administration
NOTICES
Agency Information Collection Activities; Proposals, Submissions, and 
          Approvals:
    Reporting and Performance Standards System for Migrant and Seasonal 
            Farmworker Programs, 74140-74141
States' Applications for Relief from Tax Credit Reductions under the 
          Federal Unemployment Tax Act, 74144
Worker Adjustment Assistance Eligibility; Determinations, 74137-74144
Worker Adjustment Assistance Eligibility; Investigations, 74135-74137


Energy Department
See Bonneville Power Administration
See Federal Energy Regulatory Commission
PROPOSED RULES
Energy Conservation Program:
    Test Procedures for Portable Air Conditioners, 74020-74039
NOTICES
Charter Renewals:
    National Coal Council, 74099


Environmental Protection Agency
RULES
Air Quality State Implementation Plans; Approvals and Promulgations:
    Virginia; Revision to the Definition of Volatile Organic Compound, 
            73995-73998
PROPOSED RULES
Air Quality State Implementation Plans; Approvals and Promulgations:
    Virginia; Revision to the Definition of Volatile Organic Compound, 
            74067-74068
Oil and Natural Gas Sector; National Emission Standards for Hazardous 
          Air Pollutants, 74068-74070
NOTICES
Agency Information Collection Activities; Proposals, Submissions, and 
          Approvals:
    Lead Training, Certification, Accreditation and Authorization 
            Activities, 74103
Environmental Impact Statements; Availability, etc.; Weekly Receipts, 
          74104

[[Page iv]]




Federal Aviation Administration
RULES
Airworthiness Directives:
    Airbus Airplanes, 73960-73963
    Fokker Services B.V. Airplanes, 73963-73965
    SOCATA Airplanes, 73955-73957
    The Boeing Company Airplanes, 73949-73955
    Viking Air Limited Airplanes, 73957-73960
PROPOSED RULES
Airworthiness Directives:
    Airbus Airplanes, 74042-74047, 74058-74061
    Dassault Aviation Airplanes, 74056-74058
    Fokker Services B.V. Airplanes, 74039-74042
    The Boeing Company Airplanes, 74047-74056
Proposed Amendment of Class C Airspace:
    Capital Region International Airport, MI, 74061-74063
Proposed Amendment of Class D and Class E Airspace:
    Walla Walla, WA, 74063-74064
NOTICES
Petitions for Exemptions; Summaries:
    Israel Aerospace Industries Ltd, 74189-74190


Federal Communications Commission
NOTICES
Instructions for Application to Participate in the Reverse Auction, 
          74104
Intent to Terminate 214 Authorization, 74104-74105


Federal Energy Regulatory Commission
RULES
Third-Party Provision of Primary Frequency Response Service, 73965-
          73977
Transmission Operations Reliability Standards and Interconnection 
          Reliability Operations and Coordination Reliability 
          Standards, 73977-73991
NOTICES
Agency Information Collection Activities; Proposals, Submissions, and 
          Approvals, 74101-74103
Combined Filings, 74099-74101
Filings:
    City of West Memphis, AR, 74100
    Conway Corp., 74100


Federal Motor Carrier Safety Administration
NOTICES
Commercial Driver's Licenses; Exemption Applications:
    Oregon Department of Transportation, 74199-74200
Qualification of Drivers; Exemption Applications:
    Atlantic and Pacific Freightways, Inc., 74202-74203
    Diabetes, 74196-74199
    Diabetes Mellitus, 74190-74196
    Implantable Cardioverter Defibrillators, 74200-74202


Federal Reserve System
RULES
Appraisals for Higher-Priced Mortgage Loans Exemption Threshold, 73943-
          73945
Consumer Lending, 73945-73947
Truth in Lending, 73947-73949
NOTICES
Changes in Bank Control:
    Acquisitions of Shares of a Bank or Bank Holding Company, 74105
Formations of, Acquisitions by, and Mergers of Bank Holding Companies, 
          74105


Financial Crimes Enforcement Network
PROPOSED RULES
Imposition of Special Measures:
    FBME Bank Ltd., Formerly Known as the Federal Bank of the Middle 
            East Ltd.; Financial Institution of Primary Money 
            Laundering Concern, 74064-74067


Food and Drug Administration
RULES
Accreditation of Third-Party Certification Bodies To Conduct Food 
          Safety Audits and To Issue Certifications, 74570-74667
Environmental Impact Statements; Availability, etc.:
    Standards for the Growing, Harvesting, Packing, and Holding of 
            Produce for Human Consumption, 74670-74672
Foreign Supplier Verification Programs for Importers of Food for Humans 
          and Animals, 74226-74352
Standards for the Growing, Harvesting, Packing, and Holding of Produce 
          for Human Consumption, 74354-74568
NOTICES
Meetings:
    Vaccines and Related Biological Products Advisory Committee, 74113-
            74114


Food and Nutrition Service
NOTICES
Agency Information Collection Activities; Proposals, Submissions, and 
          Approvals:
    Federal Claims Collection Methods for Supplemental Nutrition 
            Assistance Program Recipient Claims, 74071-74073


Foreign Assets Control Office
NOTICES
Blocking or Unblocking of Persons and Properties, 74215-74217


General Services Administration
NOTICES
Agency Information Collection Activities; Proposals, Submissions, and 
          Approvals:
    Freight Classification Description, 74105-74106


Government Ethics Office
PROPOSED RULES
Standards of Ethical Conduct for Employees of the Executive Branch:
    Solicitation and Acceptance of Gifts From Outside Sources, 74004-
            74018


Health and Human Services Department
See Centers for Disease Control and Prevention
See Centers for Medicare & Medicaid Services
See Food and Drug Administration
See Health Resources and Services Administration
See National Institutes of Health


Health Resources and Services Administration
NOTICES
Meetings:
    Advisory Committee on Interdisciplinary, Community-Based Linkages, 
            74114-74115


Homeland Security Department
See U.S. Immigration and Customs Enforcement
PROPOSED RULES
Privacy Act; Implementation of Exemptions, 74018-74020

[[Page v]]

NOTICES
Privacy Act; Systems of Records, 74116-74120


Housing and Urban Development Department
NOTICES
Federal Property Suitable as Facilities To Assist the Homeless, 74121-
          74123


Indian Affairs Bureau
NOTICES
Gila River Indian Community Alcoholic Beverages Ordinance, 74124-74129
Petitions for Federal Acknowledgment of American Indian Tribes, 74123-
          74124


Interior Department
See Indian Affairs Bureau
See Land Management Bureau
See National Park Service
See Reclamation Bureau


Internal Revenue Service
NOTICES
Agency Information Collection Activities; Proposals, Submissions, and 
          Approvals, 74217-74218


International Trade Commission
NOTICES
Investigations; Determinations, Modifications, and Rulings, etc.:
    Certain Welded Line Pipe From Korea and Turkey, 74133
Meetings; Sunshine Act, 74134


Justice Department
NOTICES
Proposed Consent Decrees Under the Clean Air Act, 74134-74135
Proposed Stipulation and Agreed Judgment Under the System Unit Resource 
          Protection Act, 74134


Labor Department
See Employment and Training Administration
See Occupational Safety and Health Administration


Land Management Bureau
NOTICES
Meetings:
    Sagebrush Focal Areas Proposed Withdrawal, Oregon; Cancellation, 
            74129


Maritime Administration
NOTICES
Requests for Administrative Waivers of the Coastwise Trade Laws:
    Vessel AKARI II, 74207-74208
    Vessel CAROBELLE, 74208-74209
    Vessel CHEYENNE, 74204-74205
    Vessel HOYA SAXA, 74206
    Vessel LOCURA, 74203-74204
    Vessel MAGNA CARTA, 74208
    Vessel MUSIC, 74205
    Vessel TRINITY, 74207
    Vessel VAN DUTCH, 74205-74206
    Vessel VELLAMO, 74206-74207
Requests for Applications:
    Potential Award of Maritime Security Program Operating Agreements, 
            74209-74210


National Aeronautics and Space Administration
NOTICES
Agency Information Collection Activities; Proposals, Submissions, and 
          Approvals:
    Freight Classification Description, 74105-74106


National Agricultural Statistics Service
NOTICES
Agency Information Collection Activities; Proposals, Submissions, and 
          Approvals, 74073


National Institutes of Health
NOTICES
Agency Information Collection Activities; Proposals, Submissions, and 
          Approvals:
    Agricultural Health Study--A Prospective Cohort Study of Cancer and 
            Other Disease Among Men and Women in Agriculture, 74115-
            74116


National Oceanic and Atmospheric Administration
RULES
Fisheries of the Caribbean, Gulf of Mexico, and South Atlantic:
    Coastal Migratory Pelagic Resources of the Gulf of Mexico and South 
            Atlantic; Accountability Measure and Closure for King 
            Mackerel in the Florida West Coast Northern Subzone, 74001-
            74002
    Reef Fish Fishery of the Gulf of Mexico; Red Snapper Commercial 
            Quota Retention, 73999-74001
Fisheries of the Western Pacific:
    Pacific Island Pelagic Fisheries; Commonwealth of the Northern 
            Mariana Islands Longline Bigeye Tuna Fishery; Closure, 
            74002-74003
NOTICES
Agency Information Collection Activities; Proposals, Submissions, and 
          Approvals, 74074-74075
Meetings:
    Caribbean Fishery Management Council, 74075-74076
    Fisheries of the Caribbean; Southeast Data, Assessment, and Review, 
            74076
    Fisheries of the South Atlantic; Southeast Data, Assessment, and 
            Review, 74074
    Gulf of Mexico Fishery Management Council, 74073-74074
Permit Applications:
    Endangered Species; File Nos. 19331 and 19642, 74085
Takes of Marine Mammals Incidental to Specified Activities:
    Marine Mammals Incidental to a Pier Maintenance Project, 74076-
            74085


National Park Service
NOTICES
Environmental Impact Statements; Availability, etc.:
    Backcountry Management Plan, Grand Canyon National Park, AZ, 74131-
            74132
    Wilderness Stewardship Plan, Yosemite National Park, Madera, 
            Mariposa, and Tuolumne, CA, 74129-74130
National Register of Historic Places:
    Pending Nominations and Related Actions, 74130-74131


National Science Foundation
RULES
Uniform Administrative Requirements, Cost Principles, and Audit 
          Requirements for Federal Awards, 73943
NOTICES
Meetings; Sunshine Act, 74146
Permit Applications:
    Antarctic Conservation Act, 74147

[[Page vi]]

    Antarctic Conservation Act; Modifications, 74147


National Technical Information Service
NOTICES
Meetings:
    Advisory Board, 74085-74086


National Telecommunications and Information Administration
NOTICES
Establishment and Call for Nominations:
    Digital Economy Board of Advisors, 74086-74087


Navy Department
RULES
Professional Conduct of Attorneys Practicing Under the Cognizance and 
          Supervision of the Judge Advocate General; Correction, 73991


Occupational Safety and Health Administration
NOTICES
Renewal of Recognition, Applications for Expansion of Recognition:
    QPS Evaluation Services, Inc., 74144-74146


Pipeline and Hazardous Materials Safety Administration
NOTICES
Special Permit Applications:
    Actions, 74213-74215
    Delayed Applications, 74213
    Hazardous Materials, 74212
    Modifications, 74210-74211


Postal Regulatory Commission
NOTICES
New Postal Products, 74147-74148


Postal Service
NOTICES
Product Changes:
    Priority Mail Express Negotiated Service Agreement, 74148
    Priority Mail Negotiated Service Agreement, 74148


Reclamation Bureau
NOTICES
Central Valley Project Improvement Act Water Management Plans; 
          Availability, 74132-74133


Securities and Exchange Commission
NOTICES
Applications for Deregistration, 74164-74165
Applications:
    ETF Series Solutions and AlphaClone, Inc, 74177-74178
Self-Regulatory Organizations; Proposed Rule Changes:
    C2 Options Exchange, Inc., 74186-74188
    Chicago Board Options Exchange, Inc., 74149-74153
    International Securities Exchange, LLC, 74181-74184
    ISE Gemini, LLC, 74179-74181
    Miami International Securities Exchange LLC, 74167-74168
    NASDAQ OMX BX, Inc., 74165-74167, 74184-74186
    NASDAQ Stock Market, LLC, 74175-74177
    National Stock Exchange, Inc., 74155-74158
    New York Stock Exchange LLC, 74158-74164
    NYSE Arca, Inc., 74153-74155, 74169-74175
    The Options Clearing Corp., 74179


Small Business Administration
NOTICES
Disaster Declarations:
    Colorado; Amendment 1, 74188-74189
    South Carolina, 74189


Surface Transportation Board
NOTICES
Acquisition and Operation Exemptions:
    R. J. Corman Railroad Company/Carolina Lines, LLC From The 
            Baltimore and Annapolis Railroad Co. d/b/a Carolina 
            Southern Railroad Co, 74215


Transportation Department
See Federal Aviation Administration
See Federal Motor Carrier Safety Administration
See Maritime Administration
See Pipeline and Hazardous Materials Safety Administration
See Surface Transportation Board


Treasury Department
See Comptroller of the Currency
See Financial Crimes Enforcement Network
See Foreign Assets Control Office
See Internal Revenue Service
NOTICES
Agency Information Collection Activities; Proposals, Submissions, and 
          Approvals, 74218-74222


U.S. Immigration and Customs Enforcement
NOTICES
Agency Information Collection Activities; Proposals, Submissions, and 
          Approvals:
    Student and Exchange Visitor Information System, 74120-74121


Veterans Affairs Department
NOTICES
Meetings:
    Commission on Care, 74222-74223

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Separate Parts In This Issue
Part II
Health and Human Services Department, Food and Drug Administration, 
          74226-74352

[[Page vii]]

Part III
Health and Human Services Department, Food and Drug Administration, 
          74354-74568


Part IV
Health and Human Services Department, Food and Drug Administration, 
          74570-74667


Part V
Health and Human Services Department, Food and Drug Administration, 
          74670-74672

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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. 80, No. 228 / Friday, November 27, 2015 / 
Contents  

  Federal Register / Vol. 80, No. 228 / Friday, November 27, 2015 / 
Contents  

  Federal Register / Vol. 80, No. 228 / Friday, November 27, 2015 / 
Contents  

[[Page viii]]



                           2 CFR
2500.................................................73943

                           5 CFR
Proposed Rules:
2635.................................................74004

                           6 CFR
Proposed Rules:
5....................................................74018

                          10 CFR
Proposed Rules:
429..................................................74020
430..................................................74020

                          12 CFR
34...................................................73943
213..................................................73945
226 (2 documents).............................73943, 73947
1013.................................................73945
1026 (2 documents)............................73943, 73947

                          14 CFR
39 (5 documents).........73949, 73955, 73957, 73960, 73963
Proposed Rules:
39 (7 documents)........74039, 74042, 74045, 74047, 74052, 
                                              74056, 74058
71 (2 documents)..............................74061, 74063

                          18 CFR
35...................................................73965
40...................................................73977

                          21 CFR
1 (2 documents)...............................74226, 74570
11 (3 documents).......................74226, 74354, 74570
16 (2 documents)..............................74354, 74570
111..................................................74226
112 (2 documents).............................74354, 74670

                          31 CFR
Proposed Rules:
1010.................................................74064

                          32 CFR
776..................................................73991

                          34 CFR
600..................................................73991
602..................................................73991
603..................................................73991
668..................................................73991
682..................................................73991
685..................................................73991
686..................................................73991
690..................................................73991
691..................................................73991

                          40 CFR
52...................................................73995
Proposed Rules:
52...................................................74067
63...................................................74068

                          42 CFR
412..................................................73998

                          50 CFR
622 (2 documents).............................73999, 74001
665..................................................74002