[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] CONTENTS 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 ----------------------------------------------------------------------- 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 ----------------------------------------------------------------------- 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 LISTSERV electronic mailing list, go to http://listserv.access.gpo.gov and select Online mailing list archives, FEDREGTOC-L, Join or leave the list (or change settings); then follow the instructions. 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. 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