Federal Register Vol. 81, No.192,

Federal Register Volume 81, Issue 192 (October 4, 2016)

Page Range68289-68932
FR Document

81_FR_192
Current View
Page and SubjectPDF
81 FR 68319 - Promulgation of Air Quality Implementation Plans; State of Arkansas; Regional Haze and Interstate Visibility Transport Federal Implementation PlanPDF
81 FR 68931 - Child Health Day, 2016PDF
81 FR 68927 - Delegations of Authority Under Sections 610, 614(a)(1), and 506(a)(2)(A)(i)(II) of the Foreign Assistance Act of 1961PDF
81 FR 68925 - Unexpected Urgent Refugee and Migration NeedsPDF
81 FR 68480 - Sunshine Act MeetingPDF
81 FR 68460 - Sunshine Act MeetingPDF
81 FR 68289 - Amending Executive Order 13467 To Establish the Roles and Responsibilities of the National Background Investigations Bureau and Related MattersPDF
81 FR 68492 - In the Matter of Rainbow International, Corp., a/k/a Raintree Brands Incorporated; Order of Suspension of TradingPDF
81 FR 68480 - In the Matter of Infinex Ventures, Inc.; Order of Suspension of TradingPDF
81 FR 68416 - Sunshine Act MeetingPDF
81 FR 68322 - Approval and Promulgation of Air Quality Implementation Plans; Louisiana; Infrastructure State Implementation Plan Requirements for the National Ambient Air Quality StandardsPDF
81 FR 68475 - Sunshine Act: Notice of Public MeetingPDF
81 FR 68335 - General Services Administration Acquisition Regulation (GSAR); Inflation of Acquisition-Related ThresholdsPDF
81 FR 68492 - In the Matter of Sierra Resource Group, Inc.; Order of Suspension of TradingPDF
81 FR 68414 - Human Studies Review Board; Notification of Public MeetingsPDF
81 FR 68297 - Section 108 Loan Guarantee Program: Announcement of Fee To Cover Credit Subsidy CostsPDF
81 FR 68456 - Cranes and Derricks in Construction; Extension of the Office of Management and Budget's (OMB) Approval Information Collection (Paperwork) RequirementsPDF
81 FR 68457 - Occupational Exposure to Noise Standard; Extension of the Office of Management and Budget's (OMB) Approval of Information Collection (Paperwork) RequirementsPDF
81 FR 68412 - Proposed Information Collection Request; Comment Request; Final Rule at 40 CFR Part 8: Environmental Impact Assessment of Nongovernmental Activities in Antarctica (Renewal)PDF
81 FR 68445 - Agency Information Collection Activities: Petition by Entrepreneur To Remove Conditions on Permanent Resident Status, Form I-829; Revision of a Currently Approved CollectionPDF
81 FR 68446 - 60-Day Notice of Proposed Information Collection: Energy BenchmarkingPDF
81 FR 68450 - 60-Day Notice of Proposed Information Collection: Energy Benchmarking of Public HousingPDF
81 FR 68414 - Notification of a Public Meeting of the Clean Air Scientific Advisory Committee (CASAC) Oxides of Nitrogen Primary NAAQS Review PanelPDF
81 FR 68318 - Special Local Regulation; Ouachita River, Monroe, LAPDF
81 FR 68411 - Clarification of Reconsideration of the Oil and Natural Gas Sector: New Source Performance Standards; Final ActionPDF
81 FR 68369 - Fisheries of the Exclusive Economic Zone Off Alaska; Several Groundfish Species in the Bering Sea and Aleutian Islands Management AreaPDF
81 FR 68312 - Department of Defense (DoD)'s Defense Industrial Base (DIB) Cybersecurity (CS) ActivitiesPDF
81 FR 68404 - Certain Corrosion-Resistant Steel Products From the Republic of Korea: Initiation of Expedited Review of the Countervailing Duty OrderPDF
81 FR 68441 - Expansion of Global Entry to Nine Additional AirportsPDF
81 FR 68404 - Foreign-Trade Zone (FTZ) 158-Vicksburg/Jackson, Mississippi; Notification of Proposed Production Activity; MTD Consumer Group, Inc. (Lawn and Garden Equipment); Verona, MississippiPDF
81 FR 68502 - Proposed Information Collection (Inquiry Routing & Information System (IRIS)) Activity: Comment RequestPDF
81 FR 68407 - Proposed Information Collection; Comment RequestPDF
81 FR 68498 - Petition for Exemption; Summary of Petition Received; Airbus SASPDF
81 FR 68416 - Formations of, Acquisitions by, and Mergers of Bank Holding CompaniesPDF
81 FR 68459 - National Industrial Security Program Policy Advisory Committee (NISPPAC)PDF
81 FR 68378 - Estate, Gift, and Generation-Skipping Transfer Taxes; Restrictions on Liquidation of an Interest; CorrectionPDF
81 FR 68401 - Notice of Request for an Information Collection; Generic Clearance for the Collection of Qualitative Feedback on Agency Service DeliveryPDF
81 FR 68462 - Susquehanna Nuclear, LLC; Susquehanna Steam Electric Station, Units 1 and 2; Consideration of Indirect License TransferPDF
81 FR 68474 - Advisory Committee on Reactor Safeguards (ACRS); Meeting of the ACRS Subcommittee on Radiation Protection and Nuclear Materials; Notice of MeetingPDF
81 FR 68462 - Advisory Committee on Reactor Safeguards (ACRS); Meeting of the ACRS Subcommittee on Fukushima; Notice of MeetingPDF
81 FR 68461 - Advisory Committee on Reactor Safeguards (ACRS); Meeting of the ACRS Subcommittee on Fukushima; Notice of MeetingPDF
81 FR 68420 - Proposed Information Collection Activity; Comment RequestPDF
81 FR 68421 - Submission for OMB Review; Comment RequestPDF
81 FR 68461 - Advisory Committee on Reactor Safeguards (ACRS) Meeting of the ACRS Subcommittee on Metallurgy & Reactor Fuels; Notice of MeetingPDF
81 FR 68442 - Individuals and Households Program Unified GuidancePDF
81 FR 68444 - Agency Information Collection Activities: Submission for OMB Review; Comment Request; Application for Surplus Federal Real Property Public Benefit Conveyance and BRAC Program for Emergency Management UsePDF
81 FR 68443 - Agency Information Collection Activities: Submission for OMB Review; Comment Request; America's PrepareAthon! National Day of Action Event RegistrationPDF
81 FR 68501 - Proposed Collection; Comment Request for Revenue Procedure 2004-15PDF
81 FR 68500 - Additional Designations, Foreign Narcotics Kingpin Designation ActPDF
81 FR 68359 - List of Nonconforming Vehicles Decided To Be Eligible for ImportationPDF
81 FR 68499 - Transfer of Federally Assisted FacilityPDF
81 FR 68376 - Airworthiness Directives; The Boeing Company AirplanesPDF
81 FR 68373 - Airworthiness Directives; The Boeing Company AirplanesPDF
81 FR 68453 - Notice of Grand Staircase-Escalante National Monument Advisory Committee MeetingPDF
81 FR 68371 - Airworthiness Directives; The Boeing Company AirplanesPDF
81 FR 68459 - Agency Information Collection Activities: Proposed Collection; Comment RequestPDF
81 FR 68499 - Notice To Rescind Notice of Intent To Prepare Environmental Impact Statement, Route 82/85/11 Corridor, New London County, ConnecticutPDF
81 FR 68406 - Marine Mammals; File No. 20452PDF
81 FR 68403 - Submission for OMB Review; Comment RequestPDF
81 FR 68434 - Dietary Supplements: New Dietary Ingredient Notifications and Related Issues; Revised Draft Guidance for Industry; Extension of Comment PeriodPDF
81 FR 68424 - Agency Information Collection Activities; Proposed Collection; Comment Request; Information From United States Firms and Processors That Export to the European UnionPDF
81 FR 68476 - Self-Regulatory Organizations; National Stock Exchange, Inc.; Notice of Filing and Immediate Effectiveness of a Proposed Rule Change To Amend Exchange Rule 11.26 To Implement the Regulation NMS Plan To Implement a Tick Size Pilot ProgramPDF
81 FR 68456 - Notice of Lodging of Proposed Consent Decree Under the Comprehensive Environmental Response, Compensation, and Liability ActPDF
81 FR 68417 - Proposed Data Collection Submitted for Public Comment and RecommendationsPDF
81 FR 68422 - Center for Devices and Radiological Health Veteran Amputee Devices; Public Workshop; Request for CommentsPDF
81 FR 68409 - AltaGas Pomona Energy Storage Inc.; Supplemental Notice That Initial Market-Based Rate Filing Includes Request for Blanket Section 204 AuthorizationPDF
81 FR 68410 - Combined Notice of FilingsPDF
81 FR 68409 - Combined Notice of Filings #1PDF
81 FR 68502 - Voluntary Service National Advisory Committee; Notice of MeetingsPDF
81 FR 68415 - Information Collection Being Reviewed by the Federal Communications Commission Under Delegated AuthorityPDF
81 FR 68402 - Notice of Request for Extension of a Currently Approved Information CollectionPDF
81 FR 68474 - New Postal ProductsPDF
81 FR 68495 - Virtus Alternative Solutions Trust, et al.; Notice of ApplicationPDF
81 FR 68420 - Announcement of a Single-Source Supplement Grant to the National Child Welfare Capacity Building Center for TribesPDF
81 FR 68493 - Self-Regulatory Organizations; NYSE MKT LLC; Notice of Designation of Longer Period for Commission Action on a Proposed Rule Change Amending the Co-Location Services Offered by the Exchange To Add Certain Access and Connectivity FeesPDF
81 FR 68480 - Self-Regulatory Organizations; NYSE Arca, Inc.; Notice of Designation of Longer Period for Commission Action on a Proposed Rule Change Amending the Co-Location Services Offered by the Exchange To Add Certain Access and Connectivity FeesPDF
81 FR 68475 - Self-Regulatory Organizations; New York Stock Exchange LLC; Notice of Designation of Longer Period for Commission Action on a Proposed Rule Change, as Modified by Amendment No. 1, Amending the Co-Location Services Offered by the Exchange To Add Certain Access and Connectivity FeesPDF
81 FR 68492 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Designation of a Longer Period for Commission Action on Proposed Rule Change Relating to FINRA Rule 2232 (Customer Confirmations) To Require Members To Disclose Additional Pricing Information on Retail Customer Confirmations Relating to Transactions in Fixed Income SecuritiesPDF
81 FR 68493 - Self-Regulatory Organizations; Bats BZX Exchange, Inc.; Notice of Filing and Immediate Effectiveness of a Proposed Rule Change To Update BZX Rules 21.1, 21.7 and 21.9 To Align the Exchange's Rules and Functionality Applicable to the Exchange's Options Platform, BZX Options, With the Exchange's Affiliated Options Platform, EDGX Options, Which Is Operated by Bats EDGX Exchange, Inc.PDF
81 FR 68481 - Self-Regulatory Organizations; NYSE MKT LLC; Notice of Filing and Immediate Effectiveness of Proposed Rule Change Amending Rule 8313 Relating to the Exchange's Ability To Publicly Release Disciplinary Complaints, Decisions and Other Information Modeled on the Text of FINRA Rule 8313; Amending Rules and Adopting a New Rule 9291 Relating to the Imposition of Temporary or Permanent Cease and Desist Orders To Correspond to Recent Amendments by FINRA; and Making Certain Technical and Conforming Changes to Rule 9310PDF
81 FR 68295 - Medical Devices; Exemption From Premarket Notification; Method, Metallic Reduction, Glucose (Urinary, Nonquantitative) Test System in a Reagent Tablet FormatPDF
81 FR 68460 - Notice of Permit Modification Received Under the Antarctic Conservation Act of 1978PDF
81 FR 68293 - Medical Devices; Exemption From Premarket Notification: Method, Metallic Reduction, Glucose (Urinary, Nonquantitative) Test System in a Reagent Tablet FormatPDF
81 FR 68426 - Agency Information Collection Activities; Announcement of Office of Management and Budget ApprovalsPDF
81 FR 68434 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Guidance for Industry on How To Submit Information in Electronic Format to the Center for Veterinary Medicine Using the Food and Drug Administration Electronic Submission GatewayPDF
81 FR 68498 - Fifteenth Meeting of the RTCA Tactical Operations CommitteePDF
81 FR 68432 - Microbiology Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for CommentsPDF
81 FR 68435 - Workshop on Promoting Semantic Interoperability of Laboratory Data; Public Workshop; Request for CommentsPDF
81 FR 68427 - Hospira, Inc. et al.; Withdrawal of Approval of 44 New Drug Applications and 158 Abbreviated New Drug ApplicationsPDF
81 FR 68442 - Agency Information Collection Activities: Submission for OMB Review; Comment Request; Residential Basement Floodproofing CertificationPDF
81 FR 68444 - Agency Information Collection Activities: Submission for OMB Review; Comment Request; Residential Basement Floodproofing CertificationPDF
81 FR 68455 - Importer of Controlled Substances Application: Fisher Clinical Services, Inc.PDF
81 FR 68439 - National Institute of Mental Health; Amended Notice of MeetingPDF
81 FR 68440 - National Institute of Allergy and Infectious Diseases Notice of Closed MeetingPDF
81 FR 68438 - National Institute of Allergy and Infectious Diseases; Notice of Closed MeetingPDF
81 FR 68437 - National Heart, Lung, and Blood Institute; Notice of Closed MeetingPDF
81 FR 68439 - National Heart, Lung, and Blood Institute; Notice of Closed MeetingPDF
81 FR 68438 - National Heart, Lung, and Blood Institute; Notice of Closed MeetingPDF
81 FR 68438 - National Center for Complementary & Integrative Health; Notice of Closed MeetingPDF
81 FR 68440 - Center for Scientific Review; Notice of Closed MeetingsPDF
81 FR 68439 - Eunice Kennedy Shriver National Institute of Child Health & Human Development; Notice of Closed MeetingsPDF
81 FR 68441 - National Institute of Allergy and Infectious Diseases; Notice of Closed MeetingPDF
81 FR 68439 - National Institute of Allergy and Infectious Diseases; Notice of Closed MeetingPDF
81 FR 68459 - NASA Advisory Council; Science Committee; MeetingPDF
81 FR 68398 - Submission for OMB Review; Comment RequestPDF
81 FR 68416 - Submission for OMB Review; Commercial Item AcquisitionsPDF
81 FR 68461 - SES Performance Review BoardPDF
81 FR 68419 - Privacy Act of 1974; CMS Computer Match No. 2016-15; HHS Computer Match No. 1609PDF
81 FR 68421 - Proposed Information Collection Activity; Comment RequestPDF
81 FR 68454 - Certain Recombinant Factor VIII Products; Notice of Commission Determination To Grant a Joint Motion To Terminate the Investigation on the Basis of a Settlement Agreement; Termination of the InvestigationPDF
81 FR 68455 - Certain Network Devices, Related Software and Components Thereof (I) Notice of Institution of Formal Enforcement ProceedingPDF
81 FR 68408 - Proposed Collection; Comment RequestPDF
81 FR 68407 - Agency Information Collection Activities: Submission for OMB Review; Comment RequestPDF
81 FR 68398 - Agency Information Collection Activities: Proposed Collection; Comment Request-Child Nutrition Program Operations Study II (CN-OPS-II)PDF
81 FR 68405 - Endangered and Threatened Species; Announcement of a Recovery Planning Workshop and Request for InformationPDF
81 FR 68379 - Approval of California Air Plan Revisions, Sacramento Metropolitan Air Quality Management District and San Diego County Air Pollution Control DistrictPDF
81 FR 68320 - Approval of California Air Plan Revisions, Sacramento Metropolitan Air Quality Management District and San Diego County Air Pollution Control DistrictPDF
81 FR 68496 - Reporting and Recordkeeping Requirements Under OMB ReviewPDF
81 FR 68497 - Reporting and Recordkeeping Requirements Under OMB ReviewPDF
81 FR 68379 - Endangered and Threatened Wildlife and Plants; 12-Month Finding on a Petition To List the Western Glacier Stonefly as an Endangered or Threatened Species; Proposed Threatened Species Status for Meltwater Lednian Stonefly and Western Glacier StoneflyPDF
81 FR 68688 - Medicare and Medicaid Programs; Reform of Requirements for Long-Term Care FacilitiesPDF
81 FR 68467 - Applications and Amendments to Facility Operating Licenses and Combined Licenses Involving Proposed No Significant Hazards Considerations and Containing Sensitive Unclassified Non-Safeguards Information and Order Imposing Procedures for Access to Sensitive Unclassified Non-Safeguards InformationPDF
81 FR 68874 - 2016-2017 Refuge-Specific Hunting and Sport Fishing RegulationsPDF
81 FR 68299 - Credit for Increasing Research ActivitiesPDF
81 FR 68336 - General Technical, Organizational, Conforming, and Correcting Amendments to the Federal Motor Carrier Safety RegulationsPDF
81 FR 68504 - Standards Improvement Project-Phase IVPDF

Issue

81 192 Tuesday, October 4, 2016 Contents Agriculture Agriculture Department See

Economic Research Service

See

Food and Nutrition Service

See

National Institute of Food and Agriculture

See

Rural Business-Cooperative Service

See

Rural Utilities Service

Consumer Financial Protection Bureau of Consumer Financial Protection NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 68407 2016-23860 Centers Disease Centers for Disease Control and Prevention NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 68417-68419 2016-23925 Centers Medicare Centers for Medicare & Medicaid Services RULES Medicare and Medicaid Programs: Reform of Requirements for Long-Term Care Facilities, 68688-68872 2016-23503 NOTICES Privacy Act; Computer Matching Program, 68419-68420 2016-23866 Children Children and Families Administration NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 68421-68422 2016-23865 Agency Information Collection Activities; Proposals, Submissions, and Approvals: Interstate Administrative Subpoena and Notice of Interstate Lien, 68421 2016-23950 Unaccompanied Children Case Summary Form, 68420-68421 2016-23951 Single-Source Grants: National Child Welfare Capacity Building Center for Tribes, 68420 2016-23909 Coast Guard Coast Guard RULES Special Local Regulations: Ouachita River, Monroe, LA, 68318-68319 2016-23973 Commerce Commerce Department See

Foreign-Trade Zones Board

See

International Trade Administration

See

National Oceanic and Atmospheric Administration

Corporation Corporation for National and Community Service NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 68407-68408 2016-23963 Defense Department Defense Department See

Navy Department

RULES Department of Defense (DoD)'s Defense Industrial Base Cybersecurity Activities, 68312-68317 2016-23968 NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Commercial Item Acquisitions, 68416-68417 2016-23868
Drug Drug Enforcement Administration NOTICES Importers of Controlled Substances; Applications: Fisher Clinical Services, Inc., 68455-68456 2016-23887 Economic Research Economic Research Service NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 68398 2016-23869 Energy Department Energy Department See

Federal Energy Regulatory Commission

Environmental Protection Environmental Protection Agency RULES Air Quality State Implementation Plans; Approvals and Promulgations: Arkansas; Regional Haze and Interstate Visibility Transport Federal Implementation Plan, 68319 C1--2016--22508 California; Sacramento Metropolitan Air Quality Management District and San Diego County Air Pollution Control District, 68320-68322 2016-23837 Louisiana; Infrastructure State Implementation Plan Requirements for the National Ambient Air Quality Standards, 68322-68335 2016-24036 PROPOSED RULES Air Quality State Implementation Plans; Approvals and Promulgations: California; Sacramento Metropolitan Air Quality Management District and San Diego County Air Pollution Control District, 68379 2016-23838 NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 68412-68413 2016-23982 Denial of Petitions for Reconsideration: Oil and Natural Gas Sector—New Source Performance Standards; Final Action, 68411-68412 2016-23972 Meetings: Clean Air Scientific Advisory Committee Oxides of Nitrogen Primary National Ambient Air Quality Standards Review Panel, 68414 2016-23974 Human Studies Review Board, 68414-68415 2016-23987 Federal Aviation Federal Aviation Administration PROPOSED RULES Airworthiness Directives: The Boeing Company Airplanes, 68371-68378 2016-23936 2016-23938 2016-23939 NOTICES Meetings: Fifteenth RTCA Tactical Operations Committee, 68498 2016-23896 Petitions for Exemption; Summaries: Airbus SAS, 68498 2016-23960 Federal Communications Federal Communications Commission NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 68415-68416 2016-23916 Federal Election Federal Election Commission NOTICES Meetings; Sunshine Act, 68416 2016-24040 Federal Emergency Federal Emergency Management Agency NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 68443-68444 2016-23946 Agency Information Collection Activities; Proposals, Submissions, and Approvals: Application for Surplus Federal Real Property Public Benefit Conveyance and BRAC Program for Emergency Management Use, 68444-68445 2016-23947 Residential Basement Floodproofing Certification, 68442-68444 2016-23888 2016-23889 Individuals and Households Program Unified Guidance, 68442 2016-23948 Federal Energy Federal Energy Regulatory Commission NOTICES Combined Filings, 68409-68411 2016-23921 2016-23922 Initial Market-Based Rate Filings Including Requests for Blanket Section 204 Authorizations: AltaGas Pomona Energy Storage Inc., 68409 2016-23923 Federal Highway Federal Highway Administration NOTICES Environmental Impact Statements; Availability, etc.: Route 82/85/11 Corridor, New London County, CT; Rescission, 68499 2016-23934 Federal Motor Federal Motor Carrier Safety Administration RULES General Technical, Organizational, Conforming, and Correcting Amendments, 68336-68359 2016-22996 Federal Reserve Federal Reserve System NOTICES Formations of, Acquisitions by, and Mergers of Bank Holding Companies, 68416 2016-23959 Federal Transit Federal Transit Administration NOTICES Transfers of Federally Assisted Facilities, 68499-68500 2016-23940 Fish Fish and Wildlife Service RULES 2016-2017 Refuge-Specific Hunting and Sport Fishing Regulations, 68874-68921 2016-23190 PROPOSED RULES Endangered and Threatened Wildlife and Plants: Western Glacier Stonefly and Meltwater Lednian Stonefly and Western Glacier Stonefly; 12-Month Finding on Petition to List and Status, 68379-68397 2016-23710 Food and Drug Food and Drug Administration RULES Medical Devices: Method, Metallic Reduction, Glucose (Urinary, Nonquantitative) Test System in a Reagent Tablet Format, 68293-68295 2016-23899 Medical Devices; Method, Metallic Reduction, Glucose (Urinary, Nonquantitative) Test System in a Reagent Tablet Format, 68295-68297 2016-23901 NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Announcement of Office of Management and Budget Approvals, 68426 2016-23898 Guidance for Industry on How to Submit Information in Electronic Format to the Center for Veterinary Medicine Using the Food and Drug Administration Electronic Submission Gateway, 68434 2016-23897 United States Firms and Processors that Export to European Union, 68424-68426 2016-23930 Guidance: Dietary Supplements; New Dietary Ingredient Notifications and Related Issues, 68434-68435 2016-23931 Meetings: Center for Devices and Radiological Health Veteran Amputee Devices; Public Workshop, 68422-68424 2016-23924 Microbiology Devices Panel of Medical Devices Advisory Committee, 68432-68434 2016-23895 Workshop on Promoting Semantic Interoperability of Laboratory Data, 68435-68437 2016-23894 New Drug Applications: Hospira, Inc. et al.; Withdrawal, 68427-68432 2016-23893 Food and Nutrition Food and Nutrition Service NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Child Nutrition Program Operations Study II, 68398-68400 2016-23859 Foreign Assets Foreign Assets Control Office NOTICES Blocking or Unblocking of Persons and Properties, 68500-68501 2016-23942 Foreign Trade Foreign-Trade Zones Board NOTICES Production Activities: MTD Consumer Group, Inc. (Lawn and Garden Equipment), Verona, MS, Foreign-Trade Zone 158, Vicksburg and Jackson, MS, 68404 2016-23965 General Services General Services Administration RULES General Services Administration Acquisition Regulations: Inflation of Acquisition-Related Thresholds, 68335-68336 2016-24015 NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Commercial Item Acquisitions, 68416-68417 2016-23868 Health and Human Health and Human Services Department See

Centers for Disease Control and Prevention

See

Centers for Medicare & Medicaid Services

See

Children and Families Administration

See

Food and Drug Administration

See

National Institutes of Health

Homeland Homeland Security Department See

Coast Guard

See

Federal Emergency Management Agency

See

U.S. Citizenship and Immigration Services

See

U.S. Customs and Border Protection

Housing Housing and Urban Development Department RULES Section 108 Loan Guarantee Program: Announcement of Fee to Cover Credit Subsidy Costs, 68297-68299 2016-23986 NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Energy Benchmarking, 68446-68450 2016-23979 Energy Benchmarking of Public Housing, 68450-68453 2016-23978 Information Information Security Oversight Office NOTICES Meetings: National Industrial Security Program Policy Advisory Committee, 68459 2016-23958 Interior Interior Department See

Fish and Wildlife Service

See

Land Management Bureau

Internal Revenue Internal Revenue Service RULES Credit for Increasing Research Activities, 68299-68312 2016-23174 PROPOSED RULES Estate, Gift, and Generation-Skipping Transfer Taxes: Restrictions on Liquidation of an Interest; Correction, 68378-68379 2016-23957 NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 68501-68502 2016-23944 International Trade Adm International Trade Administration NOTICES Antidumping or Countervailing Duty Investigations, Orders, or Reviews: Certain Corrosion-Resistant Steel Products from Republic of Korea, 68404-68405 2016-23967 International Trade Com International Trade Commission NOTICES Enforcement Proceedings: Certain Network Devices, Related Software and Components Thereof, 68455 2016-23863 Investigations; Determinations, Modifications, and Rulings, etc.: Certain Recombinant Factor VIII Products; Termination of Investigation, 68454 2016-23864 Justice Department Justice Department See

Drug Enforcement Administration

NOTICES Proposed Consent Decrees under CERCLA, 68456 2016-23926
Labor Department Labor Department See

Occupational Safety and Health Administration

Land Land Management Bureau NOTICES Meetings: Grand Staircase-Escalante National Monument Advisory Committee, 68453-68454 2016-23937 NASA National Aeronautics and Space Administration NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Commercial Item Acquisitions, 68416-68417 2016-23868 Meetings: NASA Advisory Council; Science Committee, 68459 2016-23872 National Archives National Archives and Records Administration See

Information Security Oversight Office

NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 68459-68460 2016-23935
National Highway National Highway Traffic Safety Administration RULES List of Nonconforming Vehicles Decided to be Eligible for Importation, 68359-68369 2016-23941 National Institute Food National Institute of Food and Agriculture NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Generic Clearance for Collection of Qualitative Feedback on Agency Service Delivery, 68401-68402 2016-23956 National Institute National Institutes of Health NOTICES Meetings: Center for Scientific Review, 68440 2016-23876 Eunice Kennedy Shriver National Institute of Child Health and Human Development, 68439 2016-23875 National Center for Complementary and Integrative Health, 68438-68439 2016-23877 2016-23878 National Heart, Lung, and Blood Institute, 68437-68439 2016-23879 2016-23880 2016-23881 National Institute of Allergy and Infectious Diseases, 68438-68441 2016-23873 2016-23874 2016-23882 2016-23883 National Institute of Mental Health, 68439-68440 2016-23885 National Oceanic National Oceanic and Atmospheric Administration RULES Fisheries of the Exclusive Economic Zone Off Alaska: Several Groundfish Species in Bering Sea and Aleutian Islands Management Area, 68369-68370 2016-23969 NOTICES Endangered and Threatened Species: Recovery Planning Workshop, 68405-68406 2016-23857 Permits: Marine Mammals; File No. 20452, 68406-68407 2016-23933 National Science National Science Foundation NOTICES Antarctic Conservation Act Permits, 68460 2016-23900 National Transportation National Transportation Safety Board NOTICES Meetings; Sunshine Act, 68460-68461 2016-24090 Senior Executive Service Performance Review Board, 68461 2016-23867 Navy Navy Department NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 68408-68409 2016-23861 Nuclear Regulatory Nuclear Regulatory Commission NOTICES Facility Operating and Combined Licenses: Applications and Amendments Involving Proposed No Significant Hazards Considerations, etc., 68467-68474 2016-23210 License Transfer Applications: Susquehanna Nuclear, LLC, Susquehanna Steam Electric Station, Units 1 and 2, 68462-68466 2016-23955 Meetings: Advisory Committee on Reactor Safeguards Subcommittee on Fukushima, 68461-68462 2016-23952 2016-23953 Advisory Committee on Reactor Safeguards Subcommittee on Metallurgy and Reactor Fuels, 68461 2016-23949 Advisory Committee on Reactor Safeguards Subcommittee on Radiation Protection and Nuclear Materials, 68474 2016-23954 Occupational Safety Health Adm Occupational Safety and Health Administration PROPOSED RULES Standards Improvement Project—Phase IV, 68504-68685 2016-19454 NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Cranes and Derricks in Construction, 68456-68457 2016-23985 Occupational Exposure to Noise Standard, 68457-68459 2016-23984 Postal Regulatory Postal Regulatory Commission NOTICES New Postal Products, 68474-68475 2016-23912 Presidential Documents Presidential Documents PROCLAMATIONS Special Observances: Child Health Day (Proc. 9506), 68929-68932 2016-24171 EXECUTIVE ORDERS Defense and National Security: National Background Investigations Bureau, Establishing Rules and Responsibilities of the; Amendment to Executive Order 13467 (EO 13741), 68289-68292 2016-24066 ADMINISTRATIVE ORDERS Foreign Assistance Act of 1961; Delegation of Authority (Memorandum of April 12, 2016), 68927-68928 2016-24168 Unexpected Urgent Refugee and Migration Needs (Presidential Determination No. 2016-05 of January 13, 2016), 68923-68925 2016-24165 Railroad Retirement Railroad Retirement Board NOTICES Meetings; Sunshine Act, 68475 2016-24029 Rural Business Rural Business-Cooperative Service NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 68402-68403 2016-23914 2016-23915 Rural Utilities Rural Utilities Service NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 68403-68404 2016-23932 Securities Securities and Exchange Commission NOTICES Applications: Virtus Alternative Solutions Trust, et al., 68495-68496 2016-23911 Meetings; Sunshine Act, 68480-68481 2016-24091 Self-Regulatory Organizations: NYSE MKT, LLC, 68481-68491 2016-23902 Self-Regulatory Organizations; Proposed Rule Changes: Bats BZX Exchange, Inc., 68493-68495 2016-23904 Financial Industry Regulatory Authority, Inc., 68492 2016-23905 National Stock Exchange, Inc., 68476-68479 2016-23929 New York Stock Exchange, LLC, 68475-68476 2016-23906 NYSE Arca, Inc., 68480 2016-23907 NYSE MKT, LLC, 68493 2016-23908 Suspension of Trading Orders: Infinex Ventures, Inc., 68480 2016-24061 Rainbow International, Corp., a/k/a Raintree Brands Inc., 68492-68493 2016-24062 Sierra Resource Group, Inc., 68492 2016-23996 Small Business Small Business Administration NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals, 68496-68498 2016-23732 2016-23764 2016-23765 Transportation Department Transportation Department See

Federal Aviation Administration

See

Federal Highway Administration

See

Federal Motor Carrier Safety Administration

See

Federal Transit Administration

See

National Highway Traffic Safety Administration

Treasury Treasury Department See

Foreign Assets Control Office

See

Internal Revenue Service

U.S. Citizenship U.S. Citizenship and Immigration Services NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Petition by Entrepreneur to Remove Conditions on Permanent Resident Status, 68445-68446 2016-23981 Customs U.S. Customs and Border Protection NOTICES Expansion of Global Entry to Nine Additional Airports, 68441-68442 2016-23966 Veteran Affairs Veterans Affairs Department NOTICES Agency Information Collection Activities; Proposals, Submissions, and Approvals: Inquiry Routing and Information System, 68502 2016-23964 Meetings: Voluntary Service National Advisory Committee, 68502 2016-23920 Separate Parts In This Issue Part II Labor Department, Occupational Safety and Health Administration, 68504-68685 2016-19454 Part III Health and Human Services Department, Centers for Medicare & Medicaid Services, 68688-68872 2016-23503 Part IV Interior Department, Fish and Wildlife Service, 68874-68921 2016-23190 Part V Presidential Documents, 68923-68925, 68927-68928 2016-24168 2016-24165 Part VI Presidential Documents, 68929-68932 2016-24171 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.

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81 192 Tuesday, October 4, 2016 Rules and Regulations DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 862 [Docket No. FDA-2016-P-1026] Medical Devices; Exemption From Premarket Notification: Method, Metallic Reduction, Glucose (Urinary, Nonquantitative) Test System in a Reagent Tablet Format AGENCY:

Food and Drug Administration, HHS.

ACTION:

Final order.

SUMMARY:

The Food and Drug Administration (FDA) is publishing an order denying a petition requesting exemption from the premarket notification requirements for “method, metallic reduction, glucose (urinary, nonquantitative)” devices that are in a reagent tablet format and are classified as class II devices as urinary glucose (nonquantitative) test system (hereinafter referred to as “copper reduction tablet test”). Urinary glucose (nonquantitative) measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, hypoglycemia, and hyperglycemia. FDA is publishing this order in accordance with procedures established by the Food and Drug Administration Modernization Act of 1997 (FDAMA).

DATES:

This order is effective October 4, 2016.

FOR FURTHER INFORMATION CONTACT:

Sheila Connors, Center for Devices and Radiological Health (CDRH), Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, rm. 4620, Silver Spring, MD 20993-0002, 301-796-6181, [email protected]

SUPPLEMENTARY INFORMATION:

I. Statutory Background

Under section 513 of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 360c), FDA must classify devices into one of three regulatory classes: Class I, class II, or class III. FDA classification of a device is determined by the amount of regulation necessary to provide a reasonable assurance of the safety and effectiveness of the device. Under the Medical Device Amendments of 1976 (1976 amendments) (Pub. L. 94-295), as amended by the Safe Medical Devices Act of 1990 (Pub. L. 101-629), devices are to be classified into class I (general controls) if there is information showing that the general controls of the FD&C Act are sufficient to assure safety and effectiveness; into class II (special controls) if general controls, by themselves, are insufficient to provide reasonable assurance of safety and effectiveness, but there is sufficient information to establish special controls to provide such assurance; and into class III (premarket approval) if there is insufficient information to support classifying a device into class I or class II and the device is a life sustaining or life supporting device, or is for a use which is of substantial importance in preventing impairment of human health or presents a potential unreasonable risk of illness or injury.

Section 510(k) of the FD&C Act (21 U.S.C. 360(k)) and the implementing regulations (21 CFR part 807) require persons who intend to market a device intended for human use to submit a premarket notification (510(k)) to FDA containing information that allows FDA to determine whether the device is “substantially equivalent” within the meaning of section 513(i) of the FD&C Act to a legally marketed device that does not require premarket approval (PMA).

On November 21, 1997, the President signed into law FDAMA (Pub. L. 105-115). Section 206 of FDAMA, in part, added a new section, 510(m), to the FD&C. Section 510(m)(1) of the FD&C Act requires FDA, within 60 days after enactment of FDAMA, to publish in the Federal Register a list of each type of class II device that does not require a report under section 510(k) to provide reasonable assurance of safety and effectiveness. Section 510(m) of the FD&C Act further provides that a 510(k) will no longer be required for these devices upon the date of publication of the list in the Federal Register. FDA published that list in the Federal Register of January 21, 1998 (63 FR 3142).

Section 510(m)(2) of the FD&C Act provides that 1 day after the date of publication of the list under section 510(m)(1), FDA may exempt a class II device on its own initiative or upon petition of an interested person if FDA determines that a 510(k) is not necessary to provide a reasonable assurance of the safety and effectiveness of the device. This section requires FDA to publish in the Federal Register a notice of intent to exempt a device, or of the petition, and to provide a 30-day comment period. Within 120 days of publication of this document, FDA must publish in the Federal Register its final determination regarding the exemption of the device that was the subject of the notice. If FDA fails to respond to a petition under this section within 180 days of receiving it, the petition shall be deemed granted.

FDA classified the urinary glucose (nonquantitative) test system into class II effective July 30, 1987 (52 FR 16102 at 16122, May 1, 1987). The classification for urinary glucose (nonquantitative) test system is at § 862.1340 (21 CFR 862.1340). The urinary glucose (nonquantitative) test system is identified as a device that is intended to measure glucosuria (glucose in urine). Urinary glucose (nonquantitative) measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, hypoglycemia, and hyperglycemia. Devices under this classification regulation require premarket notification under section 510(k) of the FD&C Act.

II. Criteria for Exemption

There are a number of factors FDA may consider to determine whether a 510(k) is necessary to provide reasonable assurance of the safety and effectiveness of a class II device. These factors are discussed in the guidance the Agency issued on February 19, 1998, entitled “Procedures for Class II Device Exemptions from Premarket Notification, Guidance for Industry and CDRH Staff” (Ref. 1). Accordingly, FDA generally considers the following factors to determine whether premarket notification is necessary: (1) The device does not have a significant history of false or misleading claims or risks associated with inherent characteristics of the device; (2) characteristics of the device necessary for its safe and effective performance are well established; (3) changes in the device that could affect safety and effectiveness will either (a) be readily detectable by users by visual examination or other means such as routine testing, before causing harm, or (b) not materially increase the risk of injury, incorrect diagnosis, or ineffective treatment; and (4) any changes to the device would not be likely to result in a change in the device's classification. FDA may also consider that, even when exempting devices, these devices would still be subject to the limitations on exemptions.

III. Petition

On March 18, 2016, FDA received a petition requesting an exemption from premarket notification requirements for copper reduction tablet tests that are classified as class II devices under § 862.1340, urinary glucose (nonquantitative) test system, from Martin O'Connor, Germaine Laboratories, Inc. (See Docket No. FDA-2016-P-1026).

On May 4, 2016 (81 FR 26802), FDA published a notice in the Federal Register announcing that this petition had been received in accordance with section 510(m)(2) of the FD&C Act. On June 20, 2016 (81 FR 39929), FDA republished a notice of the petition due to an inadvertent error in the docket number and provided an opportunity for interested persons to submit comments on the petition by July 20, 2016. FDA received no comments regarding this petition.

FDA has completed review of the referenced petition and assessed the need for 510(k) clearance for copper reduction tablet test against the criteria laid out in section II. For the reasons described in this document, FDA has determined that premarket notification is necessary to provide a reasonable assurance of the safety and effectiveness of the copper reduction tablet tests classified under § 862.1340 and assigned the classification product code JIM. Accordingly, FDA responded to the petition by letter dated September 6, 2016, denying the petition within the 180-day timeframe under section 510(m)(2) of the FD&C Act. (See Docket No. FDA-2016-P-1026).

IV. Order

After reviewing the petition, FDA has determined that the petition failed to provide information to demonstrate that premarket notification is not necessary to provide a reasonable assurance of the safety and effectiveness of the device. Accordingly, FDA is denying the referenced petition for exemption from the premarket notification requirements.

With regard to the first factor (see section II, Criteria for Exemption), although there have been no medical device reports reported to the Agency in recent years, there have been numerous reports to the Agency 1 and in medical literature of risks associated with the inherent characteristics of this device, including possible device-associated deaths, serious injuries, and malfunctions such as burns, explosions of the product bottle due to heat, and consumption of the device. For instance, there have been reports in the medical literature of patients consuming the tablets because of their similarity to pills, which has led to poisoning and one report of a death. Therefore, FDA does not agree with the petitioner that the device does not have a significant history of risks associated with inherent characteristics of the device.

1 For more information, see Medical Device Reporting (MDR) database at http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/search.CFM.

Additionally, failure to observe the reaction at all times after the tablet has been added to the sample is another risk associated with the inherent characteristics of the device. This can lead to a false-negative result and result in improper patient management, which can lead to serious injury or possibly death. The petition does not address how the device's inherent risks can be mitigated or controlled without premarket notification to provide a reasonable assurance of the safety and effectiveness of the device.

With regard to the second factor, the petition stated that healthcare and laboratory professionals understand the appropriate use of a copper reduction tablet test and that a definitive diagnostic or therapeutic decision should not be based on the result of this method. However, a copper reduction tablet test can be used to evaluate pediatric patients for possible hereditary metabolic disorders through detection of reducing substances. For example, although all States require mandatory newborn screening for genetic metabolic defects, clinical laboratories may still use this device as a screening test on pediatric urine samples if there are any suspicions of metabolic disease prior to receiving newborn screening results or if the newborn screening results do not match the clinical state of the newborn. Although further diagnostic testing may be performed to confirm the result(s), physicians may immediately treat the newborn relying solely on the result of this test while awaiting the results for any followup diagnostic tests. False negative results also present a safety and effectiveness concern because followup diagnostic testing may not be performed, leading to the failure to start needed treatment for the newborn. The petition failed to demonstrate that a premarket submission is not necessary to provide a reasonable assurance of the safety and effectiveness of the device for such uses, and FDA does not agree that the characteristics of the device necessary for its safe and effective use are well established.

With regard to the third factor, FDA also does not agree that changes in the device that could affect safety and effectiveness will either be readily detectable or not materially increase risks. The petition claimed that users could employ positive or negative controls to validate the reagents performance. However, while available quality control materials may contain glucose, they do not contain other reducing sugars (e.g., galactose, lactose). Therefore, such materials might not readily detect an issue with the device's safety or effectiveness in detecting other reducing sugars before causing harm. The petition argued that well-established protocols and methods could ensure there is no material increase in risk. The petition provided insufficient information to support this argument that changes in the device that could affect safety and effectiveness will either be readily detectable or not materially increase risks. Moreover, changes in the device that could affect safety and effectiveness might materially increase the risk of injury, incorrect diagnosis or ineffective treatment given the device type's intended uses. The petition also did not provide information to the contrary. The petition did not provide any relevant information regarding the fourth factor.

In addition to these four factors, FDA considers the “limitations on exemption.” Manufacturers of any commercially distributed device for which FDA has granted an exemption from the requirement of premarket notification must still submit a premarket notification to FDA prior to marketing the device when any of the limitations of exemption are exceeded. The general limitations of exemption from premarket notification contained in § 862.9 (21 CFR 862.9) are broadly applicable to in vitro diagnostic (IVD) devices classified under part 862 (21 CFR part 862). Under § 862.9, the exemption from the premarket notification requirements applies, in the case of IVD devices, only to those devices under part 862 for which misdiagnosis, as a result of using the device, would not be associated with high morbidity or mortality. FDA has previously assessed that this limitation is exceeded, and a premarket notification is necessary to provide a reasonable assurance of the safety and effectiveness of an IVD device, when such device is intended for use in screening or diagnosis of familial or acquired genetic disorders, including inborn errors of metabolism (§ 862.9(c)(2)) or intended for use in diabetes management (§ 862.9(c)(5)). The petition argued that the copper reduction tablet test is not intended for use in screening or diagnosis of familial and acquired genetic disorders, including inborn errors of metabolism, or for use in diabetes management. However, as explained previously, FDA disagrees and believes that the copper reduction tablet test described in the petition is intended for such uses and would likely exceed the limitations previously mentioned.

Accordingly, for all of the foregoing reasons, the petition failed to demonstrate that a premarket submission is not necessary to provide a reasonable assurance of the safety and effectiveness of the device intended for such uses. Therefore, FDA is issuing this order denying the petition requesting exemption for a method, metallic reduction, glucose (urinary, nonquantitative) test system in a reagent tablet format that is intended to measure glucosuria (glucose in urine) from the premarket notification requirements. Manufacturers of this device type must continue to submit and receive FDA clearance of a 510(k) before marketing their device, as well as comply with all other applicable requirements under the FD&C Act.

V. Reference

The following reference is on display in the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, and is available for viewing by interested persons between 9 a.m. and 4 p.m., Monday through Friday; it is also available electronically at http://www.regulations.gov. FDA has verified the Web site address, as of the date this document publishes in the Federal Register, but Web sites are subject to change over time.

1. “Procedures for Class II Device Exemptions from Premarket Notification, Guidance for Industry and CDRH Staff,” February 1998, available at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM080199.pdf. Dated: September 28, 2016. Leslie Kux, Associate Commissioner for Policy.
[FR Doc. 2016-23899 Filed 10-3-16; 8:45 am] BILLING CODE 4164-01-P
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 862 [Docket No. FDA-2016-P-0159] Medical Devices; Exemption From Premarket Notification; Method, Metallic Reduction, Glucose (Urinary, Nonquantitative) Test System in a Reagent Tablet Format AGENCY:

Food and Drug Administration, HHS.

ACTION:

Final order.

SUMMARY:

The Food and Drug Administration (FDA) is publishing an order denying a petition requesting exemption from the premarket notification requirements for method, metallic reduction, glucose (urinary, nonquantitative) devices that are in a reagent tablet format and are classified as class II devices as urinary glucose (nonquantitative) test system (hereinafter referred to as ”copper reduction tablet test”). Urinary glucose (nonquantitative) measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, hypoglycemia, and hyperglycemia. FDA is publishing this order in accordance with procedures established by the Food and Drug Administration Modernization Act of 1997 (FDAMA).

DATES:

This order is effective October 4, 2016.

FOR FURTHER INFORMATION CONTACT:

Sheila Connors, Center for Devices and Radiological Health (CDRH), Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 4620, Silver Spring, MD 20993-0002, 301-796-6181, [email protected]

SUPPLEMENTARY INFORMATION:

I. Statutory Background

Under section 513 of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 360c), FDA must classify devices into one of three regulatory classes: Class I, class II, or class III. FDA classification of a device is determined by the amount of regulation necessary to provide a reasonable assurance of the safety and effectiveness of the device. Under the Medical Device Amendments of 1976 (1976 amendments) (Pub. L. 94-295), as amended by the Safe Medical Devices Act of 1990 (Pub. L. 101-629), devices are to be classified into class I (general controls) if there is information showing that the general controls of the FD&C Act are sufficient to assure safety and effectiveness; into class II (special controls) if general controls, by themselves, are insufficient to provide reasonable assurance of safety and effectiveness, but there is sufficient information to establish special controls to provide such assurance; and into class III (premarket approval) if there is insufficient information to support classifying a device into class I or class II and the device is a life-sustaining or life-supporting device, or is for a use which is of substantial importance in preventing impairment of human health, or presents a potential unreasonable risk of illness or injury.

Section 510(k) of the FD&C Act (21 U.S.C. 360(k)) and the implementing regulations (21 CFR part 807) require persons who intend to market a device intended for human use to submit a premarket notification (510(k)) to FDA containing information that allows FDA to determine whether the device is “substantially equivalent” within the meaning of section 513(i) of the FD&C Act to a legally marketed device that does not require premarket approval.

On November 21, 1997, the President signed into law FDAMA (Pub. L. 105-115). Section 206 of FDAMA, in part, added section 510(m) to the FD&C Act. Section 510(m)(1) of the FD&C Act requires FDA, within 60 days after enactment of FDAMA, to publish in the Federal Register a list of each type of class II device that does not require a report under section 510(k) of the FD&C Act to provide reasonable assurance of safety and effectiveness. Section 510(m) of the FD&C Act further provides that a 510(k) will no longer be required for these devices upon the date of publication of the list in the Federal Register. FDA published that list in the Federal Register of January 21, 1998 (63 FR 3142).

Section 510(m)(2) of the FD&C Act provides that 1 day after the date of publication of the list under section 510(m)(1), FDA may exempt a class II device on its own initiative or upon petition of an interested person, if FDA determines that a 510(k) is not necessary to provide reasonable assurance of the safety and effectiveness of the device. This section requires FDA to publish in the Federal Register a notice of intent to exempt a device, or of the petition, and to provide a 30-day comment period. Within 120 days of publication of this document, FDA must publish in the Federal Register its final determination regarding the exemption of the device that was the subject of the notice. If FDA fails to respond to a petition under this section within 180 days of receiving it, the petition shall be deemed granted.

FDA classified the urinary glucose (nonquantitative) test system into class II effective July 30, 1987 (52 FR 16102 at 16122, May 1, 1987). The classification for urinary glucose (nonquantitative) test system is at § 862.1340 (21 CFR 862.1340). The urinary glucose (nonquantitative) test system is identified as a device that is intended to measure glucosuria (glucose in urine). Urinary glucose (nonquantitative) measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, hypoglycemia, and hyperglycemia. Devices under this classification regulation require premarket notification under section 510(k) of the FD&C Act.

II. Criteria for Exemption

There are a number of factors FDA may consider to determine whether a 510(k) is necessary to provide reasonable assurance of the safety and effectiveness of a class II device. These factors are discussed in the guidance the Agency issued on February 19, 1998, entitled “Procedures for Class II Device Exemptions from Premarket Notification, Guidance for Industry and CDRH Staff” (Ref. 1). Accordingly, FDA generally considers the following factors to determine whether premarket notification is necessary: (1) The device does not have a significant history of false or misleading claims or risks associated with inherent characteristics of the device; (2) characteristics of the device necessary for its safe and effective performance are well established; (3) changes in the device that could affect safety and effectiveness will either (a) be readily detectable by users by visual examination or other means such as routine testing, before causing harm, or (b) not materially increase the risk of injury, incorrect diagnosis, or ineffective treatment; and (4) any changes to the device would not be likely to result in a change in the device's classification. FDA may also consider that, even when exempting devices, these devices would still be subject to the limitations on exemptions.

III. Petition

On January 7, 2016, FDA received a petition requesting an exemption from premarket notification requirements for copper reduction tablet tests that are classified as class II devices under § 862.1340, urinary glucose (nonquantitative) test system, from Evelyn Mirza, Biorex Labs, LLC. (See Docket No. FDA-2016-P-0159).

On March 24, 2016 (81 FR 15728), FDA published a notice in the Federal Register announcing that this petition had been received and provided an opportunity for interested persons to submit comments on the petition by April 25, 2016, in accordance with section 510(m)(2) of the FD&C Act. FDA received no comments regarding this petition.

FDA has completed review of the previously referenced petition and assessed the need for 510(k) clearance for copper reduction tablet test against the criteria laid out in section II. For the reasons described in section IV, FDA has determined that premarket notification is necessary to provide a reasonable assurance of the safety and effectiveness of the copper reduction tablet tests classified under § 862.1340 and assigned the classification product code JIM. Accordingly, FDA responded to the petition by letter dated July 1, 2016, denying the petition within the 180-day timeframe under section 510(m)(2) of the FD&C Act. (See Docket No. FDA-2016-P-0159.)

IV. Order

After reviewing the petition, FDA has determined that the petition failed to provide information to demonstrate that premarket notification is not necessary to provide reasonable assurance of the safety and effectiveness of the device. Accordingly, FDA is denying the previously referenced petition for exemption from the premarket notification requirements.

With regard to the first factor (section II, Criteria for Exemption), although there have been no medical device reports reported to the Agency in recent years, there have been numerous reports to the Agency 1 and in medical literature of risks associated with the inherent characteristics of this device, including possible device-associated deaths, serious injuries, and malfunctions such as burns, explosions of the product bottle due to heat, and consumption of the device. For instance, there have been reports in the medical literature of patients consuming the tablets because of their similarity to pills, which has led to poisoning and one report of a death. Therefore, FDA does not agree with the petitioner that the use of the device is well established without any reports of patient or user injury, or that the device does not have a significant history of risks associated with inherent characteristics of the device.

1 For more information, see Medical Device Reporting (MDR) database at http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/search.CFM.

Additionally, failure to observe the reaction at all times after the tablet has been added to the sample is another risk associated with the inherent characteristics of the device. This can lead to a false-negative result and result in improper patient management, which can lead to serious injury or possibly death. The petition failed to demonstrate how the device's inherent risks can be mitigated or controlled without premarket notification to provide a reasonable assurance of the safety and effectiveness of the device.

With regard to the second factor, the petition stated that a copper reduction tablet test can be used to evaluate pediatric patients for possible hereditary metabolic disorders through detection of reducing substances. For example, although all States require mandatory newborn screening for genetic metabolic defects, clinical laboratories may still use this device as a screening test on pediatric urine samples if there are any suspicions of metabolic disease prior to receiving newborn screening results or if the newborn screening results do not match the clinical state of the newborn. Although further diagnostic testing may be performed to confirm the result(s), physicians may immediately treat the newborn relying solely on the result of this test while awaiting the results for any followup diagnostic tests. False negative results also present a safety and effectiveness concern because followup diagnostic testing may not be performed, leading to the failure to start needed treatment for the newborn. The petition also stated that this device is used in the diagnosis, monitoring, and treatment of metabolic disorders such as diabetes mellitus. However, the petition failed to demonstrate that a premarket submission is not necessary to provide a reasonable assurance of the safety and effectiveness of the device for such uses, and FDA does not agree that the characteristics of the device necessary for its safe and effective use are well established.

With regard to the third factor, FDA also does not agree that changes in the device that could affect safety and effectiveness will either be readily detectable or not materially increase risks. For example, available quality control materials may contain glucose but do not contain other reducing sugars (e.g., galactose, lactose). Therefore, such materials might not readily detect an issue with the device's safety or effectiveness in detecting other reducing sugars, before causing harm. The petition provided insufficient information to support the position that changes in the device that could affect safety and effectiveness will either be readily detectable or not materially increase risks. Moreover, changes in the device that could affect safety and effectiveness might materially increase the risk of injury, incorrect diagnosis, or ineffective treatment given the device type's intended uses. The petition also did not provide information to the contrary. The petition did not provide any information regarding the fourth factor.

In addition to these four factors, FDA considers the “limitations on exemption.” Manufacturers of any commercially distributed device for which FDA has granted an exemption from the requirement of premarket notification must still submit a premarket notification to FDA prior to marketing the device when any of the limitations of exemption are exceeded. The general limitations of exemption from premarket notification contained in § 862.9 (21 CFR 862.9) are broadly applicable to in vitro diagnostic (IVD) devices classified under part 862 (21 CFR part 862). Under § 862.9, the exemption from the premarket notification requirements applies, in the case of IVD devices, only to those devices under part 862 for which misdiagnosis, as a result of using the device, would not be associated with high morbidity or mortality. FDA has previously assessed that this limitation is exceeded, and a premarket notification is necessary to provide a reasonable assurance of the safety and effectiveness of an IVD device, when such device is intended for use in screening or diagnosis of familial or acquired genetic disorders, including inborn errors of metabolism (§ 862.9(c)(2)) or intended for use in diabetes management (§ 862.9(c)(5)). The copper reduction tablet test described in the petition is intended for such uses and would likely exceed the limitations just described.

Accordingly, for all of the foregoing reasons, the petition failed to demonstrate that a premarket submission is not necessary to provide a reasonable assurance of the safety and effectiveness of the device intended for such uses. Therefore, FDA is issuing this order denying the petition requesting exemption for a method, metallic reduction, glucose (urinary, nonquantitative) test system in a reagent tablet format that is intended to measure glucosuria (glucose in urine) from the premarket notification requirements. Manufacturers of this device type must continue to submit and receive FDA clearance of a 510(k) before marketing their device, as well as comply with all other applicable requirements under the FD&C Act.

V. Reference

The following reference is on display in the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, and is available for viewing by interested persons between 9 a.m. and 4 p.m., Monday through Friday; it is also available electronically at http://www.regulations.gov. FDA has verified the Web site address, as of the date this document publishes in the Federal Register, but Web sites are subject to change over time.

1. “Procedures for Class II Device Exemptions from Premarket Notification, Guidance for Industry and CDRH Staff,” February 1998, available at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM080199.pdf. Dated: September 28, 2016. Leslie Kux, Associate Commissioner for Policy.
[FR Doc. 2016-23901 Filed 10-3-16; 8:45 am] BILLING CODE 4164-01-P
DEPARTMENT OF HOUSING AND URBAN DEVELOPMENT 24 CFR Part 570 [Docket No. FR-5767-N-05] RIN 2506-AC35 Section 108 Loan Guarantee Program: Announcement of Fee To Cover Credit Subsidy Costs AGENCY:

Office of the Assistant Secretary for Community Planning and Development, HUD.

ACTION:

Announcement of fee.

SUMMARY:

This document announces the fee that HUD will collect from borrowers of loans guaranteed under HUD's Section 108 Loan Guarantee Program (Section 108 Program) to offset the credit subsidy costs of the guaranteed loans pursuant to commitments awarded in FY 2017.

DATES:

Effective Date: November 3, 2016.

FOR FURTHER INFORMATION CONTACT:

Paul Webster, Director, Financial Management Division, Office of Block Grant Assistance, Office of Community Planning and Development, Department of Housing and Urban Development, 451 7th Street, SW., Room 7180, Washington, DC 20410; telephone number 202-402-4563 (this is not a toll-free number). Individuals with speech or hearing impairments may access this number through TTY by calling the toll-free Federal Relay Service at 800-877-8339. FAX inquiries (but not comments) may be sent to Mr. Webster at 202-708-1798 (this is not a toll-free number).

SUPPLEMENTARY INFORMATION:

I. Background

The Consolidated and Further Continuing Appropriations Act, 2015 (Public Law 113-235, approved December 16, 2014) (2015 Appropriations Act) provided that “the Secretary shall collect fees from borrowers . . . to result in a credit subsidy cost of zero for guaranteeing” Section 108 loans. The Continuing Appropriations Act, 2016 (Public Law 114-53, approved September 30, 2015) continued the 2015 provision. This continued funding act was followed by The Consolidated Appropriations Act, 2016, Public Law 114-133, approved December 18, 2015) (2016 Appropriations Act), which had identical language regarding Section 108 credit subsidy to the 2015 Appropriations Act. The fiscal year 2017 HUD appropriations bills under consideration in the House of Representatives (H.R. 5394), and the Senate (S. 2844) also have identical language regarding the credit subsidy for the Section 108 Program, and it is expected that, when enacted, the final fiscal year 2017 appropriations act will as well.

On November 3, 2015, HUD published a final rule (80 FR 67626) following a February 5, 2015 proposed rule (80 FR 6470) that amended the Section 108 Program regulations at 24 CFR part 570 to establish additional procedures, including procedures for determining the amount of the fee and for a 30-day public comment process when HUD adopts changes to the assumptions underlying the fee calculation or if the fee structure itself raises new considerations for borrowers.

HUD is required to collect fees from Section 108 borrowers when necessary to offset the credit subsidy costs to the Federal government to guarantee Section 108 loans. Following consideration of the public comments submitted in response to HUD's February 5, 2015 proposed rule (80 FR 6469) that proposed the fee required to offset the credit subsidy costs, on November 3, 2015, HUD issued an announcement of fee (80 FR 67634) to set the fee for Section 108 loan disbursements under loan guarantee commitments awarded in FY 2016 at 2.58 percent of the principal amount of the loan.

II. FY 2017 Fee: 2.59 Percent of the Principal Amount of the Loan

This document sets the fee for Section 108 loan disbursements under loan guarantee commitments awarded in FY 2017 at 2.59 percent of the principal amount of the loan. This amount was proposed in the President's FY 2017 budget.1 HUD will collect this fee from borrowers of loans guaranteed under the Section 108 Program to offset the credit subsidy costs of the guaranteed loans pursuant to commitments awarded in FY 2017, as authorized by the 2017 appropriations act.

1 The FY 2017 President's Budget for HUD is available at: https://www.whitehouse.gov/sites/default/files/omb/budget/fy2017/assets/hud.pdf. The fee is specified in table 6 of the Federal Credit Supplement to the 2017 budget and is available at: https://www.whitehouse.gov/sites/default/files/omb/budget/fy2017/assets/cr_supp.pdf

For this fee document, HUD is not changing the underlying assumptions or creating new considerations for borrowers. The calculation of the FY 2017 fee uses the same fee calculation model as the FY 2016 announcement of fee, but incorporates updated information regarding the composition of the Section 108 portfolio and the timing of the estimated future cash flows for defaults and recoveries. The calculation of the fee is also affected by the discount rates required to be used by HUD when calculating the present value of the future cash flows as part of the Federal budget process.

As described in 24 CFR 570.712(b), HUD's credit subsidy calculation is based on the amount required to fully offset the credit subsidy cost to the Federal government associated with making a Section 108 loan guarantee. As a result, HUD's credit subsidy cost calculations incorporated assumptions based on: (i) data on default frequency for municipal debt where such debt is comparable to loans in the Section 108 loan portfolio; (ii) data on recovery rates on collateral security for comparable municipal debt; (iii) the expected composition of the Section 108 portfolio by end users of the guaranteed loan funds (e.g., third party borrowers and public entities); and (iv) other factors that HUD determined were relevant to this calculation (e.g., assumptions as to loan disbursement and repayment patterns).

Taking these factors into consideration, HUD determined that the fee for disbursements made under loan guarantee commitments awarded in FY 2017 will be 2.59 percent, which will be applied only at the time of loan disbursements. Note that future documents may provide for a combination of up-front and periodic fees for loan guarantee commitments awarded in future fiscal years but, if so, will provide the public an opportunity to comment if appropriate under 24 CFR 570.712(b)(2).

The expected cost of a Section 108 loan guarantee is difficult to estimate using historical program data because there have been no defaults in the history of the program that required HUD to invoke its full faith and credit guarantee or use the credit subsidy reserved each year for future losses.2 This is due to a variety of factors, including the availability of Community Development Block Grant (CDBG) funds as security for HUD's guarantee as provided in 24 CFR 570.705(b). As authorized by Section 108 of the Housing and Community Development Act of 1974, as amended (42 U.S.C. 5308), borrowers may make payments on Section 108 loans using CDBG grant funds. Borrowers may also make Section 108 loan payments from other anticipated sources but continue to have CDBG funds available should they encounter shortfalls in the anticipated repayment source. Despite the program's history of no defaults, federal credit budgeting principles require that the availability of CDBG funds to repay the guaranteed loans cannot be assumed in the development of the credit subsidy cost estimate (see 80 FR 67629, November 3, 2015). Thus, the estimate must incorporate the risk that alternative sources are used to repay the guaranteed loan in lieu of CDBG funds, and that those sources may be insufficient. Based on the rate that CDBG funds are used annually for repayment of loan guarantees, HUD's calculation of the credit subsidy cost must take into account the possibility of future defaults if those CDBG funds were not available. The fee of 2.59 percent of the principal amount of the loan will offset the expected cost to the government due to default, financing costs, and other relevant factors. To arrive at this measure, HUD analyzed data on comparable municipal debt over an extended 16 to 23-year period. The estimated rate is based on the default and recovery rates for general purpose municipal debt and industrial development bonds. The cumulative default rates on industrial development bonds (14.62 percent) were higher than the default rates on general purpose municipal debt (0.25 percent) during the period from which the data were taken. (The recovery rates for industrial development bonds and general purpose debt were 74.76 and 90.27 percent, respectively.) These two subsectors of municipal debt were chosen because their purposes and loan terms most closely resemble those of Section 108 guaranteed loans. In this regard, Section 108 guaranteed loans can be broken down into two categories: (1) loans that finance public infrastructure and activities to support subsidized housing (other than financing new construction) and (2) other development projects (e.g., retail, commercial, industrial). The 2.59 percent fee was derived by weighting the default and recovery data for general purpose municipal debt and the data for industrial development bonds according to the expected composition of the Section 108 portfolio by corresponding project type. Based on the dollar amount of Section 108 loan guarantee commitments awarded during the period from FY 2011 through FY 2015, HUD expects that 25 percent of the Section 108 portfolio will be similar to general purpose municipal debt and 75 percent of the portfolio will be similar to industrial development bonds. In setting the fee at 2.59 percent of the principal amount of the guaranteed loan, HUD expects that the amount generated will fully offset the cost to the Federal government associated with making guarantee commitments awarded in FY 2017. Note that the FY 2017 fee represents only a .01 percent increase over the FY 2016 fee of 2.58 percent. This is due primarily to updated loan repayment patterns and discount rates used in calculating the present value of cash flows. These are variable that ordinarily are modified in the credit subsidy calculation.

2 U.S. Department of Housing and Urban Development, Study of HUD's Section 108 Loan Guarantee Program, (prepared by Econometrica, Inc. and The Urban Institute), September 2012.

This document establishes a rate that does not constitute a development decision that affects the physical condition of specific project areas or building sites. Accordingly, under 24 CFR 50.19(c)(6), this document is categorically excluded from environmental review under the National Environmental Policy Act of 1969 (42 U.S.C. 4321).

Dated: September 28, 2016. Harriet Tregoning, Principal Deputy Assistant, Secretary for Community Planning and Development.
[FR Doc. 2016-23986 Filed 10-3-16; 8:45 am] BILLING CODE 4210-67-P
DEPARTMENT OF THE TREASURY Internal Revenue Service 26 CFR Part 1 [TD 9786] RIN 1545-BC70 Credit for Increasing Research Activities AGENCY:

Internal Revenue Service (IRS), Treasury.

ACTION:

Final regulations.

SUMMARY:

This document contains final regulations concerning the application of the credit for increasing research activities. These final regulations provide guidance on software that is developed by (or for the benefit of) the taxpayer primarily for internal use by the taxpayer (internal use software). These final regulations also include examples to illustrate the application of the process of experimentation requirement to software. These final regulations will affect taxpayers engaged in research activities involving software.

DATES:

Effective date: These regulations are effective on October 4, 2016.

Applicability date: For date of applicability see § 1.41-4(e).

FOR FURTHER INFORMATION CONTACT:

Martha Garcia or Jennifer Records of the IRS Office of the Associate Chief Counsel (Passthroughs and Special Industries) at (202) 317-6853 (not a toll-free number).

SUPPLEMENTARY INFORMATION:

Background

This document contains final regulations that amend the Income Tax Regulations (26 CFR part 1) relating to the credit for increasing research activities (research credit) under section 41 of the Internal Revenue Code (Code). Section 41(d)(4)(E) provides that, except to the extent provided by regulations, research with respect to software that is developed by (or for the benefit of) the taxpayer primarily for internal use by the taxpayer is excluded from the definition of qualified research under section 41(d). Software that is developed for use in an activity that constitutes qualified research for purposes of section 41(d) and software that is developed for use in a production process with respect to which the general credit eligibility requirements under section 41 are satisfied are internal use software, but are not excluded under section 41(d)(4)(E) from the definition of qualified research and are not subject to these regulations.

On January 20, 2015, the Treasury Department and the IRS published in the Federal Register (80 FR 2624, January 20, 2015) a notice of proposed rulemaking (REG-153656-03, 2015-5 IRB 566) under section 41 (the proposed regulations) relating to the research credit. Comments responding to the proposed regulations were received and a public hearing was held on April 17, 2015. After consideration of all of the comments received, these final regulations adopt the proposed regulations as revised by this Treasury decision.

Summary of Comments and Explanation of Provisions I. Definition of Internal Use Software

The proposed regulations provided that software is developed by (or for the benefit of) the taxpayer primarily for internal use if the software is developed by the taxpayer for use in general and administrative functions that facilitate or support the conduct of the taxpayer's trade or business. General and administrative functions, as defined in the proposed regulations, are limited to (1) financial management functions, (2) human resource management functions, and (3) support services functions. Financial management functions are functions that involve the financial management of the taxpayer and the supporting recordkeeping. Human resource management functions are functions that manage the taxpayer's workforce. Support services functions are functions that support the day-to-day operations of the taxpayer, such as data processing or facilities services.

Commenters expressed concern that the list of general and administrative functions in the proposed regulations was overly broad and included functions that do not represent “back-office” functions. In particular, the commenters noted that inventory management, marketing, legal services, and government compliance services can provide significant benefits to third parties and may be developed to enable a taxpayer to interact with third parties or to allow third parties to initiate functions or review data on the taxpayer's system. Specifically, one commenter noted that many inventory management software applications are an integral part of a taxpayer's supply chain management system and can be readily seen as part of the modern “front office.” This commenter noted that modern inventory management software usually requires interaction with a number of third party vendors to ensure the correct flow of raw materials and a corresponding flow of finished goods. Additionally, the commenter added that inventory management is inherently customer facing because it provides the proper amount of inventory to customers at the point of sale at the right time. Another commenter added that marketing is an external-facing function by nature, and software that supports marketing is necessarily intended to interact with third parties.

The Treasury Department and the IRS understand that many modern software systems perform more than back-office functions. These software systems commonly provide benefits to vendors and include functions that are customer facing. Additionally, software with functions such as marketing or inventory management may not provide solely back-office functions, but may also contain functions that enable a taxpayer to interact with third parties or to allow third parties to initiate functions or review data on the taxpayer's system. Recognizing such situations, the proposed regulations provided rules under § 1.41-4(c)(6)(iv)(C) (dual function rules) to evaluate whether software that has both back-office and front-office functions is developed primarily for internal use. The Treasury Department and the IRS continue to believe that functions such as inventory management, marketing, legal services, and government compliance services provide support to day-to-day operations of a taxpayer in carrying on business regardless of the taxpayer's industry and that the benefits that such functions may provide to third parties are collateral and secondary. In addition, the Treasury Department and the IRS believe the dual function rules in these final regulations sufficiently address these comments by allowing taxpayers to identify subsets of elements of dual function software that only enable a taxpayer to interact with third parties or allow third parties to initiate functions or review data. Accordingly, the list of general and administrative functions provided in the proposed regulations remains unchanged in the final regulations.

Another commenter referred to the tax software example in the preamble to the proposed regulations which notes that tax software developed by a company engaged in providing tax services to its customers is not used by the taxpayer in general and administrative functions even though tax is listed under § 1.41-4(c)(6)(iii)(B)(1) of the proposed regulations, as a general and administrative function. The commenter requested that we make this concept more explicit by revising § 1.41-4(c)(6)(iii)(A) of the proposed regulations and providing additional examples. As discussed in the preamble to the proposed regulations, the list of general and administrative functions is intended to target the back-office functions that most taxpayers would have regardless of the taxpayer's industry, although the characterization of a function as back office will vary depending on the facts and circumstances of the taxpayer. Because § 1.41-4(c)(6)(v) of these final regulations makes clear that the determination of whether software is developed primarily for internal use depends on the intent of the taxpayer and the facts and circumstances at the beginning of software development, the Treasury Department and the IRS believe that additional clarifying language and examples are unnecessary.

II. Definition of Software Not Developed Primarily for Internal Use

The proposed regulations provided that software is not developed primarily for internal use only if it is developed to be commercially sold, leased, licensed, or otherwise marketed to third parties, or if it is developed to enable a taxpayer to interact with third parties or to allow third parties to initiate functions or review data on the taxpayer's system. After consideration of the comments described herein, these final regulations clarify that (1) software is not developed primarily for the taxpayer's internal use if it is not developed for use in general and administrative functions that facilitate or support the conduct of the taxpayer's trade or business; and (2) software that is developed to be commercially sold, leased, licensed, or otherwise marketed to third parties and software that is developed to enable a taxpayer to interact with third parties or to allow third parties to initiate functions or review data on the taxpayer's system are examples of software that is not developed primarily for the taxpayer's internal use.

A. Software Developed To Be Commercially Sold, Leased, Licensed or Otherwise Marketed to Third Parties

A commenter requested that § 1.41-4(c)(6)(iv)(A)(1) of the proposed regulations be revised to state that software is not developed primarily for the taxpayer's internal use if the software is developed to be commercially sold, leased, licensed, hosted, or otherwise marketed to third parties. (Emphasis added.) The commenter also recommended additional language to further define “otherwise marketed” to include transactions where the taxpayer effectively provides the functionality of the software to a third party even if there is no transfer of a copy of the software itself to such third party. The Treasury Department and the IRS understand that a taxpayer may develop software where the full functionality of that software is provided to a third party even though there is no transfer of a copy of the software. The Treasury Department and the IRS believe the phrase “software that is developed to be commercially sold, leased, licensed or otherwise marketed to third parties” is sufficiently broad to encompass hosted software and other software where there is no transfer of a copy of the software. An example has been added to further illustrate this point (Example 9 of these final regulations).

B. Software Developed To Enable a Taxpayer To Interact With Third Parties or Allow Third Parties To Initiate Functions or Review Data on the Taxpayer's System

Several commenters requested clarification on the terms “interact,” “initiate,” or “review,” and recommended additional examples illustrating the terms. One commenter noted that a common example that should be clarified is whether a third party reviewing a Web site constitutes “interaction,” “initiate functions,” or “review data.” In response to these comments, the final regulations clarify that software that is developed to enable a taxpayer to interact with third parties or to allow third parties to initiate functions or review data on the taxpayer's system are examples of software that is not developed primarily for the taxpayer's internal use. In addition, these final regulations provide that the determination of whether software is internal use or developed to enable a taxpayer to interact with third parties or to allow third parties to initiate functions or review data on the taxpayer's system depends on the intent of the taxpayer and the facts and circumstances at the beginning of the software development. Accordingly, Example 3 of the proposed regulations, now designated as Example 4 in these final regulations, is revised to show that software developed with the intent of marketing via a Web site and not to allow third parties to review data on the taxpayer's system is developed for internal use because it was developed for use in a general and administrative function.

III. Connectivity Software

In the proposed regulations, the Treasury Department and the IRS requested comments on the appropriate definition and treatment of connectivity software that allows multiple processes running on one or more machines to interact across a network, sometimes referred to as bridging software, integration software, or middleware. The Treasury Department and the IRS received very few responses to this request for comments. One of the commenters noted that the treatment of such software is challenging because of its multi-faceted purposes; it could fall within a category in which it is not sold, does not interact with a third party, and does not perform a general and administrative function. The other commenter recommended that the regulations provide a general rule for connectivity software that is tied to the intent of the taxpayer and the facts and circumstances at the beginning of the software development and that the regulations provide examples demonstrating the rule. In addition, with respect to this category of software, the Treasury Department and the IRS understand that with wide use and availability of enterprise resource planning (ERP) software, few companies actually engage in developing connectivity software. Connectivity software is often purchased or the need for it has diminished due to the use of ERP software.

After further consideration of business practices and the limited comments received, the Treasury Department and the IRS believe that a special rule for connectivity software is not needed. The final regulations clarify that software is not developed by (or for the benefit of) the taxpayer primarily for the taxpayer's internal use if the software is not developed for use in general and administrative functions. Accordingly, any software that is not developed to be used in a general and administrative function will not be considered to be developed for internal use. This is the case even if the software is not developed to be commercially sold, leased, licensed, or otherwise marketed to third parties, or is not developed to enable a taxpayer to interact with third parties or to allow third parties to initiate functions or review data on the taxpayer's system.

Furthermore, connectivity software should not be specifically identified or categorized differently from other types of software. Whether certain software is developed to be used primarily for internal use should be based on the function the software provides, rather than the type of software. For example, connectivity software that is developed to connect a taxpayer's existing payroll software with financial budgeting software to allow an exchange of data between the two software modules would be considered to be developed for the taxpayer's internal use because the connectivity software's function is to be used in human resources and financial management functions. Accordingly, the Treasury Department and the IRS believe that the general rule in the final regulations to determine whether or not software is developed primarily for internal use already provides sufficient guidance for connectivity software. Whether software, including connectivity software, is developed for use in general and administrative functions depends upon the intent of the taxpayer and the facts and circumstances at the beginning of the software development.

IV. Intent of the Taxpayer and the Facts and Circumstances at the Beginning of the Software Development

The proposed regulations provided that whether software is or is not developed primarily for internal use depends upon the intent of the taxpayer and the facts and circumstances at the beginning of the software development. If a taxpayer originally develops software primarily for internal use but later makes improvements to the software with the intent to hold the improved software for commercial sale, lease, or license or to allow third parties to initiate functions or review data on the taxpayer's system, the improvements will be considered separate from the existing software and will not be considered developed primarily for internal use. Likewise, if a taxpayer originally develops software for commercial sale, lease, or license or to interact with third parties or to allow third parties to initiate functions or review data on the taxpayer's system, but later makes improvements to the software with the intent to use the software in general and administrative functions, the improvements will be considered separate from the existing software and will be considered developed primarily for internal use. After consideration of the comments described below, these final regulations retain these rules without modification.

A commenter explained that it is common for a taxpayer to initiate a software development project with one purpose in mind and to later discover that other purposes should be considered and pursued. Commenters also explained that it is common for a taxpayer to abandon its original intentions of how the software might be used. Commenters made several different recommendations, among them that the final regulations adopt a standard that allows facts at any point during the software development to be considered. Another suggested looking to the intended use of the software, and not just the improvements, as of the tax return filing date for the taxable year or the beginning of the taxable year in which the software development expenditures were incurred. One commenter further suggested that if the regulations require a determination at the beginning of the software development, the regulations should allow that determination to be rebutted with evidence about how the software is actually used when it is placed in service. Commenters also noted that taxpayers will likely have difficulty substantiating their intended use of the software at the beginning of the development process.

The Treasury Department and the IRS conclude that only a rule that generally requires that a determination be made at the beginning of software development is consistent with the intent and the purpose of section 41. Congress intended that the credit for increasing research activities would provide an incentive for greater private activity in research. That incentive nature of section 41 is promoted by taking into account a taxpayer's intent at the beginning of the software development; allowing any change in a taxpayer's intent throughout the development to support treatment as qualifying research of expenses incurred prior to that change would frustrate the purpose of the credit. Furthermore, allowing a taxpayer to redetermine the overall project's credit eligibility throughout the development which could span multiple years would provide uncertain and inconsistent treatment and impose an undue burden on both taxpayers and the IRS. Finally, the final regulations continue to provide a special rule for improvements to software that can be separately identified. This special rule would apply, for example, when a taxpayer completes a software development and then decides to improve that software by undertaking further development to the same software.

V. Dual Function Software and Safe Harbor A. Presumption and Third Party Subset

The proposed regulations provided that software developed by (or for the benefit of) the taxpayer both for use in general and administrative functions that facilitate or support the conduct of the taxpayer's trade or business and to enable a taxpayer to interact with third parties or to allow third parties to initiate functions or review data (dual function software) is presumed to be developed primarily for a taxpayer's internal use. However, this presumption is inapplicable to the extent that a taxpayer can identify a subset of elements of dual function software that only enables a taxpayer to interact with third parties or allows third parties to initiate functions or review data on the taxpayer's system (third party subset). The proposed regulations provided that if the taxpayer can identify a third party subset, the portion of qualified research expenditures allocable to such third party subset of the dual function software may be eligible for the research credit, provided all the other applicable requirements are met.

The Treasury Department and the IRS received several comments on dual function software rules. One commenter recommended changes to clarify that the dual function software rules do not apply to software developed to be commercially sold, leased, licensed, or otherwise marketed to third parties, even if such software was also developed to enable a taxpayer to interact with third parties or to allow third parties to initiate functions or review data on the taxpayer's system.

The Treasury Department and the IRS believe such clarification is unnecessary as § 1.41-4(c)(6)(iv)(C)(1) of the proposed regulations clearly defines dual function software as software that is developed by the taxpayer both for use in general and administrative functions and to enable a taxpayer to interact with third parties or to allow third parties to initiate functions or review data. Software that is developed to be commercially sold, leased, licensed, or otherwise marketed to third parties is not dual function software, even if such software was also developed to enable a taxpayer to interact with third parties or to allow third parties to initiate functions or review data on the taxpayer's system.

One commenter suggested that the “substantially all” and “shrink back” rules found in § 1.41-4(b)(2) can be easily applied to evaluate dual function software. If substantially all of the software is non-internal use, then all of the software should be considered non-internal use under the substantially all rule. Similarly, if substantially all of the software is internal use, then the software should be considered internal use. In the case where the software as a whole does not meet the substantially all rule, then the taxpayer would apply the shrink back rule and the software would be divided into subcomponents based on functionality until the non-internal use portion and the internal use portion were appropriately separated. That commenter noted that these two rules have worked for many years with little difficulty in other areas of the research credit rules and could be used equally well to address the issue of dual function software. Another commenter encouraged the addition of a rule to cover cases in which a taxpayer's dual function subset's third party use or interaction exceeds 80 percent. The commenter stated that in this circumstance, the remaining internal use is de minimis and should be disregarded and the entire development should be treated as not developed for internal use.

The shrink back rule provides that the requirements of section 41(d) and § 1.41-4(a) are to be applied first at the level of the discrete business component, that is, the product, process, computer software, technique, formula, or invention to be held for sale, lease, or license, or used by the taxpayer in a trade or business of the taxpayer. If these requirements are not met at that level, then they apply at the most significant subset of elements of the product, process, computer software, technique, formula, or invention to be held for sale, lease, or license. This shrinking back of the product is to continue until either a subset of elements of the product that satisfies the requirements is reached, or the most basic element of the product is reached and such element fails to satisfy the test.

The Treasury Department and the IRS believe that the proposed rules already apply principles similar to the shrink back rule to allow taxpayers to identify a subset of elements of dual function software that only enables a taxpayer to interact with third parties or allows third parties to initiate functions or review data on the taxpayer's system. The substantially all test referenced by the commenter is similar to the general credit eligibility requirement in section 41(d)(1)(C), which provides that in order for activities to constitute qualified research, substantially all of the activities must constitute elements of a process of experimentation that relates to a qualified purpose. Under § 1.41-4(a)(6), this substantially all requirement is satisfied only if 80 percent or more of a taxpayer's research activities, for the development or improvement of a business component, measured on a cost or other consistently applied reasonable basis, constitute elements of a process of experimentation. In contrast to the general requirement of section 41(d)(1) pertaining to qualifying research, section 41(d)(4)(E) does not apply the substantially all test when it excludes activities related to internal use software from qualifying research. Accordingly, the Treasury Department and the IRS believe the use of the substantially all test in these regulations is inappropriate, and the final regulations do not adopt the commenter's suggested approach.

Another commenter requested that the dual function rules be eliminated because the provisions are confusing and unnecessary and that trying to delineate elements of dual function software raises significant administrative issues. Similarly, another commenter noted that the concepts in the dual function rules can be confusing to taxpayers and will require additional recordkeeping by taxpayers. According to this commenter, most taxpayers do not differentiate their software applications by “third party interactions” or generally track such interactions. One commenter similarly stated that § 1.41-4(c)(6)(iv)(C) of the proposed regulations fails to take into account that software systems cannot always be broken into mutually exclusive subsets enabling only internal use or third party functionality.

Regarding the presumption that dual function software is developed for internal use, a commenter stated that such presumption is contrary to the intent of the statute. One commenter recommended that the presumption should be replaced with a primary purpose test, consistent with the statutory language that looks to whether software is developed “primarily” for internal use.

The Treasury Department and the IRS believe it is necessary to implement rules for dual function software as this type of software development is increasingly common in business practice. Rather than simply reiterating the “primarily” language in the statute, these regulations specifically identify the types of software functions that are considered to be primarily for internal use. A definition that specifically identifies the types of software functions that are considered to be primarily for internal use provides a clearer objective test that will provide consistency in application. The nature of software and its development has rapidly evolved over time, and the statute did not expressly address the treatment of dual function software. In conjunction with crafting a narrow definition of internal use, the Treasury Department and the IRS believe that the dual function software rules in the proposed regulations strike an appropriate balance between the administrative burdens and compliance concerns relating to claiming the research credit for activities relating to software. Thus, these final regulations retain the dual function rules. These final regulations are applicable to taxable years beginning on or after the date of their publication in the Federal Register. Taxpayers have been aware of the proposed rules and have had the opportunity to begin maintaining the necessary documentation to establish their entitlement to research credits under these rules.

B. Safe Harbor

The proposed regulations provided taxpayers with a safe harbor to apply to dual function software if there remains a subset of elements of dual function software (dual function subset) after the third party subset has been identified. The safe harbor allows a taxpayer to include 25 percent of the qualified research expenditures of the dual function subset in computing the amount of the taxpayer's credit, provided that the taxpayer's research activities related to the dual function subset constitute qualified research and the use of the dual function subset by third parties or by the taxpayer to interact with third parties is reasonably anticipated to constitute at least 10 percent of the dual function subset's use.

Some commenters requested that the safe harbor be removed from the regulations. Specifically, one commenter stated that the burdens associated with the safe harbor may be greater than its benefits and noted the multiple steps that a taxpayer must take to determine if it meets the safe harbor. Another commenter noted that the safe harbor complicates the administration of the credit for both taxpayers and the IRS.

Another commenter noted that the safe harbor potentially penalizes the taxpayer with the inequitable result of allowing only 25 percent of the qualified research expenditures. According to the commenter, given that a taxpayer must document anticipated use, it should then follow that the portion of software treated as third party facing should mirror this analysis. In other words, the proportion anticipated to be third party facing should be the proportion of software that is not developed primarily for internal use.

After careful consideration, the final regulations do not adopt these comments. However, the safe harbor has been modified to clarify that the safe harbor can be applied to the dual function software or the dual function subset after the application of § 1.41-4(c)(6)(vi)(B) of the final regulations. The safe harbor is not a requirement but an option available for taxpayers who cannot identify a third party subset, or after identification of a third party subset, still have a dual function subset. Without the safe harbor, dual function software or a dual function subset would be presumed to be internal use and the taxpayer would have to demonstrate that the research with respect to the dual function software or dual function subset meets the high threshold of innovation test in addition to the general eligibility requirements under section 41(d)(1). The safe harbor provides a benefit, not a detriment, to taxpayers, provided the dual function software or dual function subset's use by third parties is anticipated to be at least 10 percent of the total use. Taxpayers who consider it too burdensome to comply with the requirements of the safe harbor can choose not to rely upon it.

C. Time of Determination

Several commenters noted concerns with the time of determination for the application of the safe harbor. A commenter noted that determining the percentage of third party use based upon an estimate made at the beginning of software development imposes an undue administrative burden and may not be an accurate reflection of the actual use once the software is released. This commenter requested that the rule be eliminated or amended to provide that a taxpayer must estimate third party use once the software is deployed. Similarly, another commenter noted that it has not been their experience that taxpayers plot out the future expected use of their software at the time the development begins with such specificity, especially given that software development is an iterative development process where functionality and expected uses rapidly evolve. Lastly, another commenter requested that, similar to the provisions for improvements to existing software, there should be a mechanism to recharacterize software over time.

While the Treasury Department and the IRS understand commenters' concerns, the final regulations do not change the requirement that the time of determination occur at the beginning of the software development. As discussed herein, the Treasury Department and the IRS continue to believe that the rule requiring that a determination be made at the beginning of the software development is most accurate and appropriate given Congress' intent that the research credit serve as an incentive to conduct qualifying research rather than an unanticipated reward for doing so.

D. Objective Reasonable Method

In the proposed regulations, the Treasury Department and the IRS invited comments on the administrability of measuring the reasonably anticipated use of software by taxpayers to interact with third parties and by third parties to initiate functions or review data based on reasonable methods (such as processing time, amount of data transfer, number of software user interface screens, number of third party initiated functions, and other objective, reasonable methods) and whether the regulations should include specific reasonable methods and examples.

A commenter recommended that due to the wide range of taxpayers that will be subject to these regulations, the final regulations should not provide overly detailed examples of “reasonable methods.” This commenter noted that it should be clear that any examples of reasonable methods are for illustrative purposes only and any reasonable method may be acceptable. Another commenter recommended the adoption of the phrase “within each industry” to ensure that the application of the objective, reasonable method takes into account unique aspects of all taxpayers within given industries.

The Treasury Department and the IRS agree that it is unrealistic to impose one specific method that will be used to measure reasonably anticipated use due to the variety of industries that are subject to the final regulations. Therefore, the final regulations provide that any objective, reasonable method within the taxpayer's industry may be used for purposes of the safe harbor.

VI. Third Party Definition

The proposed regulations provided that the term “third party” means any corporation, trade or business, or other person that is not treated as a single taxpayer with the taxpayer pursuant to section 41(f). A commenter raised concerns and requested that the Treasury Department and the IRS reconsider whether it is appropriate to apply the controlled group standard under section 41(f). The commenter contended that this third party definition would potentially deny a research credit to some software for artificial reasons. The commenter further noted that if the regulations do not modify the third party definition, taxpayers should at least have an opportunity to demonstrate that software provided to a member of the controlled group is not internal use software based on the facts and circumstances.

The Treasury Department and the IRS continue to believe that the use of the controlled group standard under section 41(f) is appropriate. A well established, objective standard is essential and using the standard in section 41(f) is consistent with the reference to section 41(f) in section 41(b)(2) relating to in-house research expenditures and in § 1.41-6(a)(3)(ii) relating to the definition of controlled group for purposes of aggregating expenditures.

The proposed regulations also provided that third parties do not include any persons that use the software to support the taxpayer's general and administrative functions that facilitate or support the conduct of the taxpayer's trade or business, e.g., the taxpayer's own vendors. A commenter contended that excluding any person that uses a taxpayer's software to support a general and administrative function from the definition of third party creates confusion and blurs a well-conceived, objective measurement. This commenter believes the term third party suggests a person who is external to the organization or a person who is not an employee. The Treasury Department and the IRS note that the statute provides a higher standard for internal use software, in part, because the benefits of such software are intended primarily for the taxpayer developing it. Where a taxpayer develops software for internal use, any benefit to others, such as vendors or those who provide support services to the taxpayer, is collateral and secondary. Accordingly, the final regulations do not adopt these comments requesting a change to the definition of third party.

VII. High Threshold of Innovation—Significant Economic Risk

The proposed regulations provided that certain internal use software is eligible for the research credit if the software satisfies the high threshold of innovation test, the three parts of which are (1) software is innovative in that the software would result in a reduction in cost or improvement in speed or other measurable improvement, that is substantial and economically significant, if the development is or would have been successful; (2) software development involves significant economic risk in that the taxpayer commits substantial resources to the development and there is a substantial uncertainty, because of technical risk, that such resources would be recovered within a reasonable period; and (3) software is not commercially available for use by the taxpayer in that the software cannot be purchased, leased, or licensed and used for the intended purpose without modifications that would satisfy the innovation and significant economic risk requirements. The proposed regulations further provided that substantial uncertainty exists if, at the beginning of the taxpayer's activities, the information available to the taxpayer does not establish the capability or method for developing or improving the software.

A. Design Uncertainty

Several commenters requested that the final regulations include design uncertainty in the definition of technical risk for purposes of meeting the significant economic risk test. Commenters noted that both sections 174 and 41 have long included the concept of design uncertainty. Commenters also raised concerns that the statute and regulations do not define the concepts of capability, methodology, and design uncertainty. Commenters further explained that these three types of uncertainties are inherently related to each other, and it is often difficult for taxpayers to clearly state or describe which type of uncertainty they face.

The use of the word “substantial” before “uncertainty” in the significant economic risk test for internal use software indicates a higher threshold of uncertainty than that required for business components that are not internal use software. While there may be design uncertainty in the development of internal use software, substantial uncertainty generally exists only when there is also uncertainty in regard to the capability or method of achieving the intended result. However, the Treasury Department and the IRS understand that it is difficult to delineate the types of technical uncertainties and attempting to do so may lead to unnecessary burdens on both taxpayers and the IRS. Furthermore, the appropriate design uncertainty of internal use software may be inextricably linked to substantial uncertainty regarding capability or method. The focus of the significant economic risk test should be on the level of uncertainty that exists and not the types of uncertainty. For these reasons, the final regulations remove the reference to capability and method uncertainty. However, the Treasury Department and the IRS believe that internal use software research activities that involve only uncertainty related to appropriate design, and not capability or methodology, would rarely qualify as having substantial uncertainty for purposes of the high threshold of innovation test.

B. Substantial Resources/Reasonable Time Period

A commenter requested that the final regulations provide further explanation or examples on what constitutes “substantial resources” or a “reasonable time period” for purposes of meeting the significant economic risk test. The Treasury Department and the IRS believe that whether the amount of resources committed is substantial or whether substantial resources would be recovered within a reasonable time period are factual determinations to be resolved based on the taxpayer's facts and circumstances and, therefore, further explanation or examples would be too specific and not helpful. Accordingly, the final regulations do not adopt these comments.

C. Application of High Threshold of Innovation Test

Another commenter requested deletion of the statement, “[i]t is not always necessary to have a revolutionary discovery or creation of new technologies such as a new programming language, operating system, architecture, or algorithm to satisfy the high threshold of innovation test.” The commenter is concerned that the sentence can be read to imply that in some situations it will be necessary to have a revolutionary discovery to qualify internal use software for the research credit. The Treasury Department and the IRS did not intend the inclusion of this statement to have the interpretation suggested or taken by the commenter. Accordingly, the Treasury Department and the IRS agree that this statement should be removed from the final regulations because a revolutionary discovery is not required to meet the high threshold of innovation test.

Furthermore, the Treasury Department and the IRS are revising §§ 1.41-4(c)(6)(i) and (ii) of the proposed regulations to clarify that the internal use software rules under § 1.41-4(c)(6) do not apply to (1) software developed for use in an activity that constitutes qualified research, (2) software developed for use in a production process to which the requirements of section 41(d)(1) are met, and (3) a new or improved package of software and hardware developed together by the taxpayer as a single product. Accordingly, under the final regulations, the high threshold of innovation test applies only to the software developed for use in general and administrative functions that facilitate or support the conduct of the taxpayer's trade or business and to dual function software.

VIII. Examples A. Process of Experimentation

Section 1.41-4(a)(8) of the proposed regulations provided six new examples illustrating the application of the process of experimentation requirement to software under section 41(d)(1)(C).

One commenter noted that the examples appear to suggest a presumption that activities related to developing web design or ERP software do not meet the process of experimentation requirement. This commenter requested that the final regulations clearly state the reasons for such presumption. The proposed regulations and these final regulations do not establish a presumption against a particular type of software; rather these examples focus on the facts and circumstances surrounding activities to determine whether they involve a process of experimentation.

Another commenter requested that the final regulations include additional examples demonstrating fact patterns that do not initially qualify as a process of experimentation but where a change in facts introduces technical uncertainty that requires a process of experimentation. The final regulations could provide examples describing a particular change in facts that would introduce technical uncertainty and require a process of experimentation; however, because the examples are very factual and would differ based on a taxpayer's business, we do not think more examples would provide the clarification that the commenter is seeking. Accordingly, the final regulations do not include additional examples to address this comment.

i. Example 6

Section 1.41-4(a)(8), Example 6, of the proposed regulations analyzed whether activities related to selecting a commercial software vendor with object-oriented functions and selecting and incorporating the specific functions into new software developed by X involved conducting a process of experimentation.

One commenter noted that the use of certain terms in Example 6, such as “develop,” “evaluate,” and “determine” suggest that the process of experimentation criteria may be met and recommended changes to clearly show that a purchase, installation, and selection from pre-determined categories do not meet a process of experimentation. We disagree with the commenter because the use or nonuse of certain terms is not an implication that the process of experimentation criteria has or has not been met. This example is intended to show that the process of experimentation requirement is not met regardless of the terms used. Accordingly, the final regulations do not adopt this comment.

ii. Example 7

Section 1.41-4(a)(8), Example 7, of the proposed regulations analyzed whether when developing software, activities relating to X's decision to use a separate server to distribute the workload across each of the web servers and X's decision that a round robin workload distribution algorithm is appropriate for its needs involved conducting a process of experimentation.

Two commenters recommended removing Example 7. One commenter believed that the example did not provide any clarification. The other commenter stated that the example shows a failure to meet the technical uncertainty requirement under section 174, rather than a process of experimentation. While the Treasury Department and the IRS agree with the commenter that activities under section 174 must be for the purpose of discovering information that would eliminate uncertainties, Example 7 is intended to demonstrate the process of experimentation requirement under section 41(d). The example shows a taxpayer's failure to meet the process of experimentation requirement under section 41(d)(1) because the use of a technique or design, such as a round robin workload distribution algorithm, does not qualify where the taxpayer did not conduct a process of evaluating alternatives intended to eliminate uncertainty regarding the development of software. Accordingly, the final regulations do not adopt these comments.

iii. Example 8

Section 1.41-4(a)(8), Example 8, of the proposed regulations analyzed whether X's activities relating to design and systematic testing and evaluation of several different algorithms in the development of load balancing software involved conducting a process of experimentation.

One commenter recommended that all references to the terms “dynamic” and “highly volatile” be removed because the commenter believes the terms provide no additional value and that they suggest that the nature of X's business environment has some bearing on the performance of qualified research. The Treasury Department and the IRS disagree and the final regulations do not adopt the commenter's recommendation because we believe the nature of a taxpayer's business environment can be a valuable indicator of circumstances that may result in the necessary uncertainty required for a process of experimentation.

Another commenter requested that for both Example 8 and Example 10, the Treasury Department and the IRS provide clarification by applying the high threshold of innovation test once the software is determined to be internal use software. Additionally, this commenter requested that the final regulations provide an additional example addressing this process. The Treasury Department and the IRS note that the examples are added to illustrate only the application of a process of experimentation to software research. They are not meant to address the high threshold of innovation test; those examples were provided under § 1.41-4(c)(6)(vi) of the proposed regulations. Furthermore, a comprehensive example that applies the rules contained in § 1.41-4(c)(6) would require more developed facts and layers of analysis and would be better suited for a different type of published guidance than these final regulations. Accordingly, the final regulations do not adopt these comments.

iv. Example 9

Section 1.41-4(a)(8), Example 9, of the proposed regulations analyzed whether X's activities relating to the installation of an ERP system involved a process of experimentation.

Two commenters requested deletion of the phrase “routine programming” in Example 9 because the term is subjective, immeasurable, and inconsistent with Suder v. Commissioner, T.C. Memo 2014-201. One commenter also stated that taxpayers may confront uncertainty about the appropriate design of the configuration of an ERP system, and the example does not address this technical uncertainty. The Treasury Department and the IRS did not intend to illustrate in this example the types of uncertainty that must be eliminated to satisfy the process of experimentation requirement under section 41(d)(1). Rather, this example demonstrates a taxpayer's failure to meet the process of experimentation requirement under section 41(d)(1) because X did not conduct a process of evaluating alternatives in order to eliminate uncertainty regarding the development of the ERP software. Accordingly, the Treasury Department and the IRS believe further clarification of these examples is unnecessary. Furthermore, the Tax Court's decision in Suder is not inconsistent with Example 9 because in Suder the court did not address whether “routine programming” could meet the process of experimentation requirement.

B. Internal Use Software

The proposed regulations provided examples illustrating the provisions contained in § 1.41-4(c)(6) of the proposed regulations.

i. Example 3

Section 1.41-4(c)(6)(vi), Example 3, of the proposed regulations analyzed whether software that is developed for a Web site that provides general information about the taxpayer's business, and which does not enable a taxpayer to interact with third parties or allow third parties to initiate functions or review data, is internal use software.

One commenter disagreed with the characterization of the facts in Example 3 which illustrates a support services function. The commenter believes that the software is dual function software that is developed to allow a third party to review data and to be used in marketing. The Treasury Department and the IRS disagree with the commenter's characterization of Example 3. The example demonstrates that the software is intended to serve marketing purposes and thus is developed to be used in general and administrative functions. Changes were made to clarify this example which is designated as Example 4 of the final regulations.

ii. Example 6

Section 1.41-4(c)(6)(vi), Example 6, of the proposed regulations analyzed the definition of third parties, specifically whether software that is developed to allow its users to upload and modify photographs at no charge allows third parties to initiate functions on the taxpayer's system.

A commenter believed the example is an important example that comes to the correct conclusion, but the commenter believed it is not a particularly good fact pattern to illustrate the third party interaction exclusion. Specifically, the commenter requested changes to the conclusion of the example to show that the advertising software is developed for use in a marketing function to an unrelated third party.

The purpose of the example is to illustrate the third party definition and to demonstrate whether the software is developed to allow third parties to initiate functions or review data. The example is not meant to address which, if any, general and administrative function applies to the software. Accordingly, the final regulations do not adopt this comment. However, other changes were made to clarify Example 6 of the proposed regulations, which is designated as Example 8 of the final regulations.

IX. Effective/Applicability Date

Some commenters requested that the final regulations apply retroactively back to 1986, while one commenter requested that the final regulations apply retroactively back to 2004 to give software development equal treatment with all other types of qualified research as defined under TD 9104 (69 FR 22). After further consideration, the effective date in the proposed regulations is generally retained with slight modifications. These final regulations are prospective and apply to taxable years beginning on or after the date of publication of this Treasury decision in the Federal Register.

Retroactive application of these final regulations may provide an unfair advantage to taxpayers whose prior taxable years are not closed by the statute of limitations. Furthermore, retroactively determining whether taxpayers engaged in research activities does not further the purpose of section 41 which is to encourage taxpayers to engage in qualifying research activities within the United States and would impose a significant administrative burden on the IRS.

Section 41(d)(4)(E) provides that, except to the extent provided by regulations, research with respect to computer software that is developed by (or for the benefit of) the taxpayer primarily for internal use by the taxpayer is excluded from the definition of qualified research under section 41(d). The nature of software and its development has rapidly evolved over time. Recognizing the evolving nature of software technology and its role in business practices, these final regulations more narrowly define internal use software than the rules that apply for prior periods. These final regulations are not, and should not be viewed as, an interpretation of prior regulatory guidance. Software not developed for internal use under these final regulations, such as software developed to enable a taxpayer to interact with third parties, may or may not have been internal use software under prior law.

The proposed regulations provided that the 2004 ANPRM (published in the Federal Register (69 FR 43)) is withdrawn effective for taxable years beginning on or after January 20, 2015, the date the proposed regulations were published in the Federal Register (80 FR 2624). For taxable years ending before January 20, 2015, taxpayers may choose to follow either all of the internal use software provisions of § 1.41-4(c)(6) in the final regulations published on January 3, 2001 in the Federal Register (TD 8930; 66 FR 280) or all of the internal use software provisions of § 1.41-4(c)(6) contained in the proposed regulations (REG-112991-01) published on December 26, 2001 in the Federal Register (66 FR 66362). In addition, the IRS will not challenge return positions consistent with all of paragraph (c)(6) of these final regulations or all of paragraph (c)(6) of the proposed regulations for any taxable year that both ends on or after January 20, 2015, the date the proposed regulations were published in the Federal Register (80 FR 2624), and begins before October 4, 2016.

X. Duty of Consistency

Some commenters noted the administrative difficulties of applying the duty of consistency rule under section 41(c)(6)(A) and requested guidance on how to comply with the consistency rule.

The duty of consistency is a statutory requirement and existing regulations under §§ 1.41-3(d) and 1.41-9(c) provide sufficient guidance for taxpayers to follow. In computing the research credit, qualified research expenses and gross receipts must be determined on a basis consistent with the definition of qualified research expenses and gross receipts for the credit year. These final regulations do not modify this existing law. Section 1.41-3(d) provides that in computing the credit for increasing research activities, qualified research expenses and gross receipts taken into account in computing a taxpayer's fixed-base percentage and a taxpayer's base amount must be determined on a basis consistent with the definition of qualified research expenses and gross receipts for the credit year, without regard to the law in effect for the taxable years taken into account in computing the fixed-base percentage or the base amount. Section 1.41-3(d) also provides examples illustrating the requirement. Current section 1.41-9(c) contains similar rules. Accordingly, the final regulations do not adopt the commenters' suggestions concerning the duty of consistency.

Special Analyses

Certain IRS regulations, including this one, are exempt from the requirements of Executive Order 12866, as supplemented and reaffirmed by Executive Order 13563. Therefore, a regulatory impact assessment is not required. It also has been determined that section 553(b) of the Administrative Procedure Act (5 U.S.C. chapter 5) does not apply to these regulations, and because the regulations do not impose a collection of information on small entities, the Regulatory Flexibility Act (5 U.S.C. chapter 6) does not apply. Pursuant to section 7805(f) of the Code, the notice of proposed rulemaking was submitted to the Chief Counsel for Advocacy of the Small Business Administration for comment on its impact on small business, and no comments were received.

Drafting Information

The principal author of these regulations is Martha M. Garcia, Office of the Associate Chief Counsel (Passthroughs and Special Industries), IRS. However, other personnel from the Treasury Department and the IRS participated in their development.

List of Subjects in 26 CFR Part 1

Income taxes, Reporting and recordkeeping requirements.

Adoption of Amendments to the Regulations

Accordingly, 26 CFR part 1 is amended as follows:

PART 1—INCOME TAXES Paragraph 1. The authority citation for part 1 is amended by adding an entry in numerical order to read in part as follows: Authority:

26 U.S.C. 7805 * * *

Section 1.41-4 also issued under 26 U.S.C. 41(d)(4)(E).

Par. 2. Section 1.41-0 is amended by: 1. Revising the entry in the table of contents for § 1.41-4(c)(6). 2. Adding entries in the table of contents for § 1.41-4(c)(6)(i) through (viii).

The revision and additions read as follows:

§ 1.41-0. Table of contents.
§ 1.41-4. Qualified research for expenditures paid or incurred in taxable years ending on or after December 31, 2003.

(c) * * *

(6) Internal use software.

(i) General rule.

(ii) Inapplicability of the high threshold of innovation test.

(iii) Software developed primarily for internal use.

(iv) Software not developed primarily for internal use.

(v) Time and manner of determination.

(vi) Software developed for both internal use and to enable interaction with third parties (dual function software).

(vii) High threshold of innovation test.

(viii) Illustrations.

Par. 3. Section 1.41-4 is amended by: 1. Adding Example 5 through Example 10 at the end of paragraph (a)(8). 2. Revising paragraphs (c)(6) and (e).

The additions and revisions read as follows:

§ 1.41-4 Qualified research for expenditures paid or incurred in taxable years ending on or after December 31, 2003.

(a) * * *

(8) * * *

Example 5.

(i) Facts. X, a retail and distribution company, wants to upgrade its warehouse management software. X evaluates several of the alternative warehouse management software products available from vendors in the marketplace to determine which product will best serve X's technical requirements. X selects vendor V's software.

(ii) Conclusion. X's activities to select the software are not qualified research under section 41(d)(1) and paragraph (a)(5) of this section. X did not conduct a process of evaluating alternatives in order to eliminate uncertainty regarding the development of a business component. X's evaluation of products available from vendors is not a process of experimentation.

Example 6.

(i) Facts. X wants to develop a new web application to allow customers to purchase its products online. X, after reviewing commercial software offered by various vendors, purchases a commercial software package of object-oriented functions from vendor Z that X can use in its web application (for example, a shopping cart). X evaluates the various object-oriented functions included in vendor Z's software package to determine which functions it can use. X then incorporates the selected software functions in its new web application software.

(ii) Conclusion. X's activities related to selecting the commercial software vendor with the object-oriented functions it wanted, and then selecting which functions to use, are not qualified research under section 41(d)(1) and paragraph (a)(5) of this section. In addition, incorporating the selected object-oriented functions into the new web application software being developed by X did not involve conducting a process of evaluating alternatives in order to eliminate uncertainty regarding the development of software. X's evaluation of products available from vendors and selection of software functions are not a process of experimentation.

Example 7.

(i) Facts. In order to be more responsive to user online requests, X wants to develop software to balance the incoming processing requests across multiple web servers that run the same set of software applications. Without evaluating or testing any alternatives, X decides that a separate server will be used to distribute the workload across each of the web servers and that a round robin workload distribution algorithm is appropriate for its needs.

(ii) Conclusion. X's activities to develop the software are activities relating to the development of a separate business component under section 41(d)(2)(A). X's activities to develop the load distribution function are not qualified research under section 41(d)(1) and paragraph (a)(5) of this section. X did not conduct a process of evaluating different load distribution alternatives in order to eliminate uncertainty regarding the development of software. X's selection of a separate server and a round robin distribution algorithm is not a process of experimentation.

Example 8.

(i) Facts. X must develop load balancing software across a server cluster supporting multiple web applications. X's web applications have high concurrency demands because of a dynamic, highly volatile environment. X is uncertain of the appropriate design of the load balancing algorithm, given that the existing evolutionary algorithms did not meet the demands of their highly volatile web environment. Therefore, X designs and systematically tests and evaluates several different algorithms that perform the load distribution functions.

(ii) Conclusion. X's activities to develop software are activities to develop a separate business component under section 41(d)(2)(A). X's activities involving the design, evaluation, and systematic testing of several new load balancing algorithms meet the requirements as set forth in paragraph (a)(5) of this section. X's activities constitute elements of a process of experimentation because X identified uncertainties related to the development of a business component, identified alternatives intended to eliminate those uncertainties, and evaluated one or more alternatives to achieve a result where the appropriate design was uncertain at the beginning of X's research activities.

Example 9.

(i) Facts. X, a multinational manufacturer, wants to install an enterprise resource planning (ERP) system that runs off a single database so that X can track orders more easily, and coordinate manufacturing, inventory, and shipping among many different locations at the same time. In order to successfully install and implement ERP software, X evaluates its business needs and the technical requirements of the software, such as processing power, memory, storage, and network resources. X devotes the majority of its resources in implementing the ERP system to evaluating the available templates, reports, and other standard programs and choosing among these alternatives in configuring the system to match its business process and reengineering its business process to match the available alternatives in the ERP system. X also performs some data transfer from its old system, involving routine programming and one-to-one mapping of data to be exchanged between each system.

(ii) Conclusion. X's activities related to the ERP software including the data transfer are not qualified research under section 41(d)(1) and paragraph (a)(5) of this section. X did not conduct a process of evaluating alternatives in order to eliminate uncertainty regarding the development of software. X's activities in choosing between available templates, reports, and other standard programs and conducting data transfer are not elements of a process of experimentation.

Example 10.

(i) Facts. Same facts as Example 9 except that X determines that it must interface part of its legacy software with the new ERP software because the ERP software does not provide a particular function that X requires for its business. As a result, X must develop an interface between its legacy software and the ERP software, and X evaluates several data exchange software applications and chooses one of the available alternatives. X is uncertain as to how to keep the data synchronized between the legacy and ERP systems. Thus, X engages in systematic trial and error testing of several newly designed data caching algorithms to eliminate synchronization problems.

(ii) Conclusion. Substantially all of X's activities with respect to this ERP project do not satisfy the requirements for a process of experimentation. However, when the shrinking-back rule is applied, a subset of X's activities do satisfy the requirements for a process of experimentation. X's activities to develop the data caching software and keeping the data on the legacy and ERP systems synchronized meet the requirements of qualified research as set forth in paragraph (a)(2) of this section. Substantially all of X's activities to develop the specialized data caching and synchronization software constitute elements of a process of experimentation because X identified uncertainties related to the development of a business component, identified alternatives intended to eliminate those uncertainties, and evaluated alternatives to achieve a result where the appropriate design of that result was uncertain as of the beginning of the taxpayer's research activities.

(c) * * *

(6) Internal use software—(i) General rule. Research with respect to software that is developed by (or for the benefit of) the taxpayer primarily for the taxpayer's internal use is eligible for the research credit only if—

(A) The research with respect to the software satisfies the requirements of section 41(d)(1);

(B) The research with respect to the software is not otherwise excluded under section 41(d)(4) (other than section 41(d)(4)(E)); and

(C) The software satisfies the high threshold of innovation test of paragraph (c)(6)(vii) of this section.

(ii) Inapplicability of the high threshold of innovation test. This paragraph (c)(6) does not apply to the following:

(A) Software developed by (or for the benefit of) the taxpayer primarily for internal use by the taxpayer for use in an activity that constitutes qualified research (other than the development of the internal use software itself);

(B) Software developed by (or for the benefit of) the taxpayer primarily for internal use by the taxpayer for use in a production process to which the requirements of section 41(d)(1) are met; and

(C) A new or improved package of software and hardware developed together by the taxpayer as a single product (or to the costs to modify an acquired software and hardware package), of which the software is an integral part, that is used directly by the taxpayer in providing services in its trade or business. In these cases, eligibility for the research credit is to be determined by examining the combined hardware-software product as a single product.

(iii) Software developed primarily for internal use—(A) In general. Except as otherwise provided in paragraph (c)(6)(vi) of this section, software is developed by (or for the benefit of) the taxpayer primarily for the taxpayer's internal use if the software is developed for use in general and administrative functions that facilitate or support the conduct of the taxpayer's trade or business. Software that the taxpayer develops primarily for a related party's internal use will be considered internal use software. A related party is any corporation, trade or business, or other person that is treated as a single taxpayer with the taxpayer pursuant to section 41(f).

(B) General and administrative functions. General and administrative functions are:

(1) Financial management. Financial management functions are functions that involve the financial management of the taxpayer and the supporting recordkeeping. Financial management functions include, but are not limited to, functions such as accounts payable, accounts receivable, inventory management, budgeting, cash management, cost accounting, disbursements, economic analysis and forecasting, financial reporting, finance, fixed asset accounting, general ledger bookkeeping, internal audit, management accounting, risk management, strategic business planning, and tax.

(2) Human resources management. Human resources management functions are functions that manage the taxpayer's workforce. Human resources management functions include, but are not limited to, functions such as recruiting, hiring, training, assigning personnel, and maintaining personnel records, payroll, and benefits.

(3) Support services. Support services are other functions that support the day- to-day operations of the taxpayer. Support services include, but are not limited to, functions such as data processing, facility services (for example, grounds keeping, housekeeping, janitorial, and logistics), graphic services, marketing, legal services, government compliance services, printing and publication services, and security services (for example, video surveillance and physical asset protection from fire and theft).

(iv) Software not developed primarily for internal use. Software is not developed primarily for the taxpayer's internal use if it is not developed for use in general and administrative functions that facilitate or support the conduct of the taxpayer's trade or business, such as—

(A) Software developed to be commercially sold, leased, licensed, or otherwise marketed to third parties; or

(B) Software developed to enable a taxpayer to interact with third parties or to allow third parties to initiate functions or review data on the taxpayer's system.

(v) Time and manner of determination. For purposes of paragraphs (c)(6)(iii) and (iv) of this section, whether software is developed primarily for internal use or not developed primarily for internal use depends on the intent of the taxpayer and the facts and circumstances at the beginning of the software development. For example, software will not be considered internal use software solely because it is used internally for purposes of testing prior to commercial sale, lease, or license. If a taxpayer originally develops software primarily for internal use, but later makes improvements to the software with the intent to hold the improved software to be sold, leased, licensed, or otherwise marketed to third parties, or to interact with third parties or to allow third parties to initiate functions or review data on the taxpayer's system using the improved software, the improvements will be considered separate from the existing software and will not be considered developed primarily for internal use. Alternatively, if a taxpayer originally develops software to be sold, leased, licensed, or otherwise marketed to third parties, or to interact with third parties or to allow third parties to initiate functions or review data on the taxpayer's system, but later makes improvements to the software with the intent to use the software in general and administrative functions, the improvements will be considered separate from the existing software and will be considered developed primarily for internal use.

(vi) Software developed for both internal use and to enable interaction with third parties (dual function software)—(A) Presumption of development primarily for internal use. Unless paragraph (c)(6)(vi)(B) or (C) of this section applies, software developed by (or for the benefit of) the taxpayer both for use in general and administrative functions that facilitate or support the conduct of the taxpayer's trade or business and to enable a taxpayer to interact with third parties or to allow third parties to initiate functions or review data on the taxpayer's system (dual function software) is presumed to be developed primarily for a taxpayer's internal use.

(B) Identification of a subset of elements of software that only enables interaction with third parties. To the extent that a taxpayer can identify a subset of elements of dual function software that only enables a taxpayer to interact with third parties or allows third parties to initiate functions or review data (third party subset), the presumption under paragraph (c)(6)(vi)(A) of this section does not apply to such third party subset, and such third party subset is not developed primarily for internal use as described under paragraph (c)(6)(iv)(B) of this section.

(C) Safe harbor for expenditures related to software developed for both internal use and to enable interaction with third parties. If, after the application of paragraph (c)(6)(vi)(B) of this section, there remains dual function software or a subset of elements of dual function software (dual function subset), a taxpayer may include 25 percent of the qualified research expenditures of such dual function software or dual function subset in computing the amount of the taxpayer's credit. This paragraph (c)(6)(vi)(C) applies only if the taxpayer's research activities related to the development or improvement of the dual function software or dual function subset constitute qualified research under section 41(d), without regard to section 41(d)(4)(E), and the dual function software or dual function subset's use by third parties or by the taxpayer to interact with third parties is reasonably anticipated to constitute at least 10 percent of the dual function software or the dual function subset's use. An objective, reasonable method within the taxpayer's industry must be used to estimate the dual function software or dual function subset's use by third parties or by the taxpayer to interact with third parties. An objective, reasonable method may include, but is not limited to, processing time, amount of data transfer, and number of software user interface screens.

(D) Time and manner of determination. A taxpayer must apply this paragraph (c)(6)(vi) based on the intent of the taxpayer and the facts and circumstances at the beginning of the software development.

(E) Third party. For purposes of paragraphs (c)(6)(iv), (v), and (vi) of this section, the term third party means any corporation, trade or business, or other person that is not treated as a single taxpayer with the taxpayer pursuant to section 41(f). Additionally, for purposes of paragraph (c)(6)(iv)(B) of this section, third parties do not include any persons that use the software to support the general and administrative functions of the taxpayer.

(vii) High threshold of innovation test—(A) In general. Software satisfies this paragraph (c)(6)(vii) only if the taxpayer can establish that—

(1) The software is innovative;

(2) The software development involves significant economic risk; and

(3) The software is not commercially available for use by the taxpayer in that the software cannot be purchased, leased, or licensed and used for the intended purpose without modifications that would satisfy the requirements of paragraphs (c)(6)(vii)(A)(1) and (2) of this section.

(B) Innovative. Software is innovative if the software would result in a reduction in cost or improvement in speed or other measurable improvement, that is substantial and economically significant, if the development is or would have been successful. This is a measurable objective standard, not a determination of the unique or novel nature of the software or the software development process.

(C) Significant economic risk. The software development involves significant economic risk if the taxpayer commits substantial resources to the development and if there is substantial uncertainty, because of technical risk, that such resources would be recovered within a reasonable period. The term “substantial uncertainty” requires a higher level of uncertainty and technical risk than that required for business components that are not internal use software. This standard does not require technical uncertainty regarding whether the final result can ever be achieved, but rather whether the final result can be achieved within a timeframe that will allow the substantial resources committed to the development to be recovered within a reasonable period. Technical risk arises from uncertainty that is technological in nature, as defined in paragraph (a)(4) of this section, and substantial uncertainty must exist at the beginning of the taxpayer's activities.

(D) Application of high threshold of innovation test. The high threshold of innovation test of paragraph (c)(6)(vii) of this section takes into account only the results anticipated to be attributable to the development of new or improved software at the beginning of the software development independent of the effect of any modifications to related hardware or other software. The implementation of existing technology by itself is not evidence of innovation, but the use of existing technology in new ways could be evidence of a high threshold of innovation if it resolves substantial uncertainty as defined in paragraph (c)(6)(vii)(C) of this section.

(viii) Illustrations. The following examples illustrate provisions contained in this paragraph (c)(6). No inference should be drawn from these examples concerning the application of section 41(d)(1) and paragraph (a) of this section to these facts.

Example 1.

Computer hardware and software developed as a single product—(i) Facts. X is a telecommunications company that developed high technology telephone switching hardware. In addition, X developed software that interfaces directly with the hardware to initiate and terminate a call, along with other functions. X designed and developed the hardware and software together.

(ii) Conclusion. The telecommunications software that interfaces directly with the hardware is part of a package of software and hardware developed together by the taxpayer that is used by the taxpayer in providing services in its trade or business. Accordingly, this paragraph (c)(6) does not apply to the software that interfaces directly with the hardware as described in paragraph (c)(6)(ii)(C) of this section, and eligibility for the research credit is determined by examining the combined software-hardware product as a single product.

Example 2.

Internal use software; financial management—(i) Facts. X, a manufacturer, self-insures its liabilities for employee health benefits. X develops its own software to administer its self-insurance reserves related to employee health benefits. At the beginning of the development, X does not intend to develop the software for commercial sale, lease, license, or to be otherwise marketed to third parties or to enable X to interact with third parties or to allow third parties to initiate functions or review data on X's system.

(ii) Conclusion. The software is developed for use in a general and administrative function because reserve valuation is a financial management function under paragraph (c)(6)(iii)(B)(1) of this section. Accordingly, the software is internal use software because it is developed for use in a general and administrative function.

Example 3.

Internal use software; human resources management—(i) Facts. X, a manufacturer, develops a software module that interacts with X's existing payroll software to allow X's employees to print pay stubs and make certain changes related to payroll deductions over the internet. At the beginning of the development, X does not intend to develop the software module for commercial sale, lease, license, or to be otherwise marketed to third parties or to enable X to interact with third parties or to allow third parties to initiate functions or review data on X's system.

(ii) Conclusion. The employee access software module is developed for use in a general and administrative function because employee access software is a human resources management function under paragraph (c)(6)(iii)(B)(2) of this section. Accordingly, the software module is internal use software because it is developed for use in a general and administrative function.

Example 4.

Internal use software; support services—(i) Facts. X, a restaurant, develops software for a Web site that provides information, such as items served, price, location, phone number, and hours of operation for purposes of advertising. At the beginning of the development, X does not intend to develop the Web site software for commercial sale, lease, license, or to be otherwise marketed to third parties or to enable X to interact with third parties or to allow third parties to initiate functions or review data on X's system. X intends to use the software for marketing by allowing third parties to review general information on X's Web site.

(ii) Conclusion. The software is developed for use in a general and administrative function because the software was developed to be used by X for marketing which is a support services function under paragraph (c)(6)(iii)(B)(3) of this section. Accordingly, the software is internal use software because it is developed for use in a general and administrative function.

Example 5.

Internal use software—(i) Facts. X, a multinational manufacturer with different business and financial systems in each of its divisions, undertakes a software development project aimed at integrating the majority of the functional areas of its major software systems (Existing Software) into a single enterprise resource management system supporting centralized financial systems, human resources, inventory, and sales. X purchases software (New Software) upon which to base its enterprise-wide system. X has to develop software (Developed Software) that transfers data from X's legacy financial, human resources, inventory, and sales systems to the New Software. At the beginning of the development, X does not intend to develop the software for commercial sale, lease, license, or to be otherwise marketed to third parties or to enable X to interact with third parties or to allow third parties to initiate functions or review data on X's system.

(ii) Conclusion. The financial systems, human resource systems, inventory and sales systems are general and administrative functions under paragraph (c)(6)(iii)(B) of this section. Accordingly, the Developed Software is internal use software because it is developed for use in general and administrative functions.

Example 6.

Internal use software; definition of third party—(i) Facts. X develops software to interact electronically with its vendors to improve X's inventory management. X develops the software to enable X to interact with vendors and to allow vendors to initiate functions or review data on the taxpayer's system. X defines the electronic messages that will be exchanged between X and the vendors. X's software allows a vendor to request X's current inventory of the vendor's product, and allows a vendor to send a message to X which informs X that the vendor has just made a new shipment of the vendor's product to replenish X's inventory. At the beginning of development, X does not intend to develop the software for commercial sale, lease, license, or to be otherwise marketed to third parties.

(ii) Conclusion. Under paragraph (c)(6)(vi)(E) of this section, X's vendors are not third parties for purposes of paragraph (c)(6)(iv) of this section. While X's software was developed to allow vendors to initiate functions or review data on the taxpayer's system, the software is not excluded from internal use software as set forth in paragraph (c)(6)(iv)(B) of this section because the software was developed to allow vendors to use the software to support X's inventory management, which is a general and administrative function of X.

Example 7.

Not internal use software; third party interaction—(i) Facts. X, a manufacturer of various products, develops software for a Web site with the intent to allow third parties to access data on X's database, to order X's products and track the status of their orders online. At the beginning of the development, X does not intend to develop the Web site software for commercial sale, lease, license, or to be otherwise marketed to third parties.

(ii) Conclusion. The software is not developed primarily for internal use because it is not developed for use in a general and administrative function. X developed the software to allow third parties to initiate functions or review data on the taxpayer's system as provided under paragraph (c)(6)(iv)(B) of this section.

Example 8.

Not internal use software; third party interaction—(i) Facts. X developed software that allows its users to upload and modify photographs at no charge. X earns revenue by selling advertisements that are displayed while users enjoy the software that X offers for free. X also developed software that has interfaces through which advertisers can bid for the best position in placing their ads, set prices for the ads, or develop advertisement campaign budgets. At the beginning of the development, X intended to develop the software to enable X to interact with third parties or to allow third parties to initiate functions on X's system.

(ii) Conclusion. The software for uploading and modifying photographs is not developed primarily for internal use because it is not developed for use in X's general and administrative functions under paragraph (c)(6)(iii)(A) of this section. The users and the advertisers are third parties for purposes of paragraph (c)(6)(iv) of this section. Furthermore, both the software for uploading and modifying photographs and the advertising software are not internal use software under paragraph (c)(6)(iv)(B) of this section because at the beginning of the development X developed the software with the intention of enabling X to interact with third parties or to allow third parties to initiate functions on X's system.

Example 9.

Not internal use software; commercially sold, leased, licensed, or otherwise marketed—(i) Facts. X is a provider of cloud-based software. X develops enterprise application software (including customer relationship management, sales automation, and accounting software) to be accessed online and used by X's customers. At the beginning of development, X intended to develop the software for commercial sale, lease, license, or to be otherwise marketed to third parties.

(ii) Conclusion. The software is not developed primarily for internal use because it is not developed for use in a general and administrative function. X developed the software to be commercially sold, leased, licensed, or otherwise marketed to third parties under paragraph (c)(6)(iv)(A) of this section.

Example 10.

Improvements to existing internal use software—(i) Facts. X has branches throughout the country and develops its own facilities services software to coordinate moves and to track maintenance requests for all locations. At the beginning of the development, X does not intend to develop the software for commercial sale, lease, license, or to be otherwise marketed to third parties or to enable X to interact with third parties or to allow third parties to initiate functions or review data on X's system. Several years after completing the development and using the software, X consults its business development department, which assesses the market for the software. X determines that the software could be sold at a profit if certain technical and functional enhancements are made. X develops the improvements to the software, and sells the improved software to third parties.

(ii) Conclusion. Support services, which include facility services, are general and administrative functions under paragraph (c)(6)(iii)(B) of this section. Accordingly, the original software is developed for use in general and administrative functions and is, therefore, developed primarily for internal use. However, the improvements to the software are not developed primarily for internal use because the improved software was not developed for use in a general and administrative function. X developed the improved software to be commercially sold, leased, licensed, or otherwise marketed to third parties under paragraphs (c)(6)(iv)(A) and (c)(6)(v) of this section.

Example 11.

Dual function software; identification of a third party subset—(i) Facts. X develops software for use in general and administrative functions that facilitate or support the conduct of X's trade or business and to allow third parties to initiate functions. X is able to identify a third party subset. X incurs $50,000 of research expenditures for the software, 50% of which is allocable to the third party subset.

(ii) Conclusion. The software developed by X is dual function software. Because X is able to identify a third party subset, the third party subset is not presumed to be internal use software under paragraph (c)(6)(vi)(A) of this section. If X's research activities related to the third party subset constitute qualified research under section 41(d), and the allocable expenditures are qualified research expenditures under section 41(b), $25,000 of the software research expenditures allocable to the third party subset may be included in computing the amount of X's credit, pursuant to paragraph (c)(6)(vi)(B) of this section. If, after the application of paragraph (c)(6)(vi)(B) of this section, there remains a dual function subset, X may determine whether paragraph (c)(6)(vi)(C) of this section applies.

Example 12.

Dual function software; application of the safe harbor—(i) Facts. The facts are the same as in Example 11, except that X is unable to identify a third party subset. X uses an objective, reasonable method at the beginning of the software development to determine that the dual function software's use by third parties to initiate functions is reasonably anticipated to constitute 15% of the dual function software's use.

(ii) Conclusion. The software developed by X is dual function software. The software is presumed to be developed primarily for internal use under paragraph (c)(6)(vi)(A) of this section. Although X is unable to identify a third party subset, X reasonably anticipates that the dual function software's use by third parties will be at least 10% of the dual function software's use. If X's research activities related to the development or improvement of the dual function software constitute qualified research under section 41(d), without regard to section 41(d)(4)(E), and the allocable expenditures are qualified research expenditures under section 41(b), X may include $12,500 (25% of $50,000) of the software research expenditures of the dual function software in computing the amount of X's credit pursuant to paragraph (c)(6)(vi)(C) of this section.

Example 13.

Dual function software; safe harbor inapplicable—(i) Facts. The facts are the same as in Example 11, except X is unable to identify a third party subset. X uses an objective, reasonable method at the beginning of the software development to determine that the dual function software's use by third parties to initiate functions is reasonably anticipated to constitute 5% of the dual function software's use.

(ii) Conclusion. The software developed by X is dual function software. The software is presumed to be developed primarily for X's internal use under paragraph (c)(6)(vi)(A) of this section. X is unable to identify a third party subset, and X reasonably anticipates that the dual function software's use by third parties will be less than 10% of the dual function software's use. X may only include the software research expenditures of the dual function software in computing the amount of X's credit if the software satisfies the high threshold of innovation test of paragraph (c)(6)(vii) of this section and X's research activities related to the development or improvement of the dual function software constitute qualified research under section 41(d), without regard to section 41(d)(4)(E), and the allocable expenditures are qualified research expenditures under section 41(b).

Example 14.

Dual function software; identification of a third party subset and the safe harbor—(i) Facts. X develops software for use in general and administrative functions that facilitate or support the conduct of X's trade or business and to allow third parties to initiate functions and review data. X is able to identify a third party subset (Subset A). The remaining dual function subset of the software (Subset B) allows third parties to review data and provides X with data used in its general and administrative functions. X is unable to identify a third party subset of Subset B. X incurs $50,000 of research expenditures for the software, 50% of which is allocable to Subset A and 50% of which is allocable to Subset B. X determines, at the beginning of the software development, that the processing time of the third party use of Subset B is reasonably anticipated to account for 15% of the total processing time of Subset B.

(ii) Conclusion. The software developed by X is dual function software. Because X is able to identify a third party subset, such third party subset (Subset A) is not presumed to be internal use software under paragraph (c)(6)(vi)(A) of this section. If X's research activities related to the development or improvement of Subset A constitute qualified research under section 41(d), and the allocable expenditures are qualified research expenditures under section 41(b), the $25,000 of the software research expenditures allocable to Subset A may be included in computing the amount of X's credit pursuant to paragraph (c)(6)(vi)(B) of this section. Although X is unable to identify a third party subset of Subset B, 15% of Subset B's use is reasonably anticipated to be attributable to the use of Subset B by third parties. If X's research activities related to the development or improvement of Subset B constitute qualified research under section 41(d), without regard to section 41(d)(4)(E), and the allocable expenditures are qualified research expenditures under 41(b), X may include $6,250 (25% x $25,000) of the software research expenditures of Subset B in computing the amount of X's credit, pursuant to paragraph (c)(6)(vi)(C) of this section.

Example 15.

Internal use software; application of the high threshold of innovation test—(i) Facts. X maintained separate software applications for tracking a variety of human resource (HR) functions, including employee reviews, salary information, location within the hierarchy and physical location of employees, 401(k) plans, and insurance coverage information. X determined that improved HR efficiency could be achieved by redesigning its disparate software applications into one employee-centric system, and worked to develop that system. X also determined that commercially available database management systems did not meet all of the requirements of the proposed system. Rather than waiting several years for vendor offerings to mature and become viable for its purpose, X embarked upon the project utilizing older technology that was severely challenged with respect to data modeling capabilities. The improvements, if successful, would provide a reduction in cost and improvement in speed that is substantial and economically significant. For example, having one employee-centric system would remove the duplicative time and cost of manually entering basic employee information separately in each application because the information would only have to be entered once to be available across all applications. The limitations of the technology X was attempting to utilize required that X attempt to develop a new database architecture. X committed substantial resources to the project, but could not predict, because of technical risk, whether it could develop the database software in the timeframe necessary so that X could recover its resources in a reasonable period. Specifically, X was uncertain regarding the capability of developing, within a reasonable period, a new database architecture using the old technology that would resolve its technological issues regarding the data modeling capabilities and the integration of the disparate systems into one system. At the beginning of the development, X did not intend to develop the software for commercial sale, lease, license, or to be otherwise marketed to third parties or to enable X to interact with third parties or to allow third parties to initiate functions or review data on X's system.

(ii) Conclusion. The software is internal use software because it is developed for use in a general and administrative function. However, the software satisfies the high threshold of innovation test set forth in paragraph (c)(6)(vii) of this section. The software was intended to be innovative in that it would provide a reduction in cost or improvement in speed that is substantial and economically significant. In addition, X's development activities involved significant economic risk in that X committed substantial resources to the development and there was substantial uncertainty, because of technical risk, that the resources would be recovered within a reasonable period. Finally, at the time X undertook the development of the system, software meeting X's requirements was not commercially available for use by X.

Example 16.

Internal use software; application of the high threshold of innovation test—(i) Facts. X undertook a software project to rewrite a legacy mainframe application using an object-oriented programming language, and to move the new application off the mainframe to a client/server environment. Both the object-oriented language and client/server technologies were new to X. This project was undertaken to develop a more maintainable application, which X expected would significantly reduce the cost of maintenance, and implement new features more quickly, which X expected would provide both significant improvements in speed and reduction in cost. Thus, the improvements, if successful, would provide a reduction in cost and improvement in speed that is substantial and economically significant. X also determined that commercially available systems did not meet the requirements of the proposed system. X was certain that it would be able to overcome any technological uncertainties and implement the improvements within a reasonable period. However, X was unsure of the appropriate methodology to achieve the improvements. At the beginning of the development, X does not intend to develop the software for commercial sale, lease, license, or to be otherwise marketed to third parties or to enable X to interact with third parties or to allow third parties to initiate functions or review data on X's system.

(ii) Conclusion. The software is internal use software because it is developed for use in a general and administrative function. X's activities do not satisfy the high threshold of innovation test of paragraph (c)(6)(vii) of this section. Although the software meets the requirements of paragraphs (c)(6)(vii)(A)(1) and (3) of this section, X's development activities did not involve significant economic risk under paragraph (c)(6)(vii)(A)(2) of this section. X did not have substantial uncertainty, because of technical risk, that the resources committed to the project would be recovered within a reasonable period.

Example 17.

Internal use software; application of the high threshold of innovation test—(i) Facts. X wants to expand its internal computing power, and is aware that its PCs and workstations are idle at night, on the weekends, and for a significant part of any business day. Because the general and administrative computations that X needs to make could be done on workstations as well as PCs, X develops a screen-saver-like application that runs on employee computers. When employees' computers have been idle for an amount of time set by each employee, X's application goes back to a central server to get a new job to execute. This job will execute on the idle employee's computer until it has either finished, or the employee resumes working on his computer. The ability to use the idle employee's computers would save X significant costs because X would not have to buy new hardware to expand the computing power. The improvements, if successful, would provide a reduction in cost that is substantial and economically significant. At the time X undertook the software development project, there was no commercial application available with such a capability. In addition, at the time X undertook the software development project, X was uncertain regarding the capability of developing a server application that could schedule and distribute the jobs across thousands of PCs and workstations, as well as handle all the error conditions that occur on a user's machine. X commits substantial resources to the project. X undertakes a process of experimentation to attempt to eliminate its uncertainty. At the beginning of the development, X does not intend to develop the software for commercial sale, lease, license, or to be otherwise marketed to third parties or to enable X to interact with third parties or to allow third parties to initiate functions or review data on X's system.

(ii) Conclusion. The software is internal use software because it is developed for use in a general and administrative function. However, the software satisfies the high threshold of innovation test as set forth in paragraph (c)(6)(vii) of this section. The software was intended to be innovative because it would provide a reduction in cost or improvement in speed that is substantial and economically significant. In addition, X's development activities involved significant economic risk in that X committed substantial resources to the development and there was substantial uncertainty that because of technical risk, such resources would be recovered within a reasonable period. Finally, at the time X undertook the development of the system, software meeting X's requirements was not commercially available for use by X.

Example 18.

Internal use software; application of the high threshold of innovation test—(i) Facts. X, a multinational manufacturer, wants to install an enterprise resource planning (ERP) system that runs off a single database. However, to implement the ERP system, X determines that it must integrate part of its old system with the new because the ERP system does not have a particular function that X requires for its business. The two systems are general and administrative software systems. The systems have mutual incompatibilities. The integration, if successful, would provide a reduction in cost and improvement in speed that is substantial and economically significant. At the time X undertook this project, there was no commercial application available with such a capability. X is uncertain regarding the appropriate design of the interface software. However, X knows that given a reasonable period of time to experiment with various designs, X would be able to determine the appropriate design necessary to meet X's technical requirements and would recover the substantial resources that X commits to the development of the system within a reasonable period. At the beginning of the development, X does not intend to develop the software for commercial sale, lease, license, or to be otherwise marketed to third parties or to enable X to interact with third parties or to allow third parties to initiate functions or review data on X's system.

(ii) Conclusion. The software is internal use software because it is developed for use in a general and administrative function. X's activities do not satisfy the high threshold of innovation test of paragraph (c)(6)(vii) of this section. Although the software meets the requirements of paragraphs (c)(6)(vii)(A)(1) and (3) of this section, X's development activities did not involve significant economic risk under paragraph (c)(6)(vii)(A)(2) of this section. X did not have substantial uncertainty, because of technical risk, that the resources committed to the project would be recovered within a reasonable period.

(e) Effective/applicability dates. Other than paragraph (c)(6) of this section, this section is applicable for taxable years ending on or after December 31, 2003. Paragraph (c)(6) of this section is applicable for taxable years beginning on or after October 4, 2016. For any taxable year that both ends on or after January 20, 2015 and begins before October 4, 2016, the IRS will not challenge return positions consistent with all of paragraph (c)(6) of this section or all of paragraph (c)(6) of this section as contained in the Internal Revenue Bulletin (IRB) 2015-5 (see www.irs.gov/pub/irs-irbs/irb15-05.pdf). For taxable years ending before January 20, 2015, taxpayers may choose to follow either all of § 1.41-4(c)(6) as contained in 26 CFR part 1 (revised as of April 1, 2003) and IRB 2001-5 (see www.irs.gov/pub/irs-irbs/irb01-05.pdf) or all of § 1.41-4(c)(6) as contained in IRB 2002-4 (see www.irs.gov/pub/irs-irbs/irb02-04.pdf).

John Dalrymple, Deputy Commissioner for Services and Enforcement. Approved: August 22, 2016. Mark J. Mazur Assistant Secretary of the Treasury (Tax Policy).
[FR Doc. 2016-23174 Filed 10-3-16; 8:45 am] BILLING CODE 4830-01-P
DEPARTMENT OF DEFENSE Office of the Secretary 32 CFR Part 236 [DOD-2014-OS-0097/RIN 0790-AJ29] Department of Defense (DoD)'s Defense Industrial Base (DIB) Cybersecurity (CS) Activities AGENCY:

Office of the DoD Chief Information Officer, DoD.

ACTION:

Final rule.

SUMMARY:

This final rule responds to public comments and updates DoD's Defense Industrial Base (DIB) Cybersecurity (CS) Activities. This rule implements mandatory cyber incident reporting requirements for DoD contractors and subcontractors who have agreements with DoD. In addition, the rule modifies eligibility criteria to permit greater participation in the voluntary DIB CS information sharing program.

DATES:

Effective Date: This rule is effective on November 3, 2016.

FOR FURTHER INFORMATION CONTACT:

Vicki Michetti, DoD's DIB Cybersecurity Program Office: (703) 604-3167, toll free (855) 363-4227, or [email protected]

SUPPLEMENTARY INFORMATION:

Purpose: This final rule responds to public comments to the interim final rule published on October 2, 2015. This rule implements statutory requirements for DoD contractors and subcontractors to report cyber incidents that result in an actual or potentially adverse effect on a covered contractor information system or covered defense information residing therein, or on a contractor's ability to provide operationally critical support. The mandatory reporting applies to all forms of agreements between DoD and DIB companies (contracts, grants, cooperative agreements, other transaction agreements, technology investment agreements, and any other type of legal instrument or agreement). The revisions provided are part of DoD's efforts to establish a single reporting mechanism for such cyber incidents on unclassified DoD contractor networks or information systems. Reporting under this rule does not abrogate the contractor's responsibility for any other applicable cyber incident reporting requirement. Cyber incident reporting involving classified information on classified contractor systems will be in accordance with the National Industrial Security Program Operating Manual (DoD-M 5220.22 (http://dtic.mil/whs/directives/corres/pdf/522022M.pdf)).

The rule also addresses the voluntary DIB CS information sharing program that is outside the scope of the mandatory reporting requirements. By modifying the eligibility criteria for the DIB CS program, the rule enables greater participation in the voluntary program. Expanding participation in the DIB CS program is part of DoD's comprehensive approach to counter cyber threats through information sharing between the Government and DIB participants.

Benefits: The DIB CS program allows eligible DIB participants to receive Government furnished information and cyber threat information from other DIB participants, thereby providing greater insights into adversarial activity targeting the DIB. The program builds trust between DoD and DIB and provides a collaborative environment for participating companies and DoD to share actionable unclassified cyber threat information that may be used to bolster cybersecurity posture. The program also offers access to government classified cyber threat information to better understand the threat, as well as providing technical assistance from the DoD Cyber Crime Center (DC3) including analyst-to-analyst exchanges, mitigation and remediation strategies, and best practices. Through cyber incident reporting and voluntary cyber threat information sharing, both DoD and the DIB have a better understanding of adversary actions and the impact on DoD information and warfighting capabilities.

Related Regulations: The definitions in the rule are consistent with Controlled Unclassified Information as used by the National Archives and Records Administration pursuant to Executive Order (E.O.) 13556 “Controlled Unclassified Information” (November 4, 2010) and 32 Code of Federal Regulations (CFR) 2002, “Controlled Unclassified Information” (September 14, 2016). The rule is also harmonized with Defense Federal Acquisition Regulation Supplement (DFARS) Case 2013-D018, “Network Penetration Reporting and Contracting for Cloud Services” and FAR Case 2011-020, “Basic Safeguarding of Contractor Information Systems.”

Authorities: The mandatory cyber incident reporting requirements support implementation of sections 391, 393, and 2224 of Title 10, United States Code (U.S.C); the Federal Information Security Modernization Act (FISMA), codified at 44 U.S.C. 3551 et seq.; and 50 U.S.C. 3330(e), and the Intelligence Authorization Act for Fiscal Year 2014. Cyber threat information sharing activities under this rule fulfill important elements of DoD's critical infrastructure protection responsibilities, as the sector specific agency for the DIB (see Presidential Policy Directive 21 (PPD-21), “Critical Infrastructure Security and Resilience,” available at https://www.whitehouse.gov/the-press-office/2013/02/12/presidential-policy-directive-critical-infrastructure-security-and-resil).

Associated Costs: Under this rule, contractors will incur costs associated with identifying and analyzing cyber incidents and their impact on covered defense information, or a contractor's ability to provide operationally critical support, and reporting those incidents to DoD. Contractors must obtain DoD-approved medium assurance certificates to ensure authentication and identification when reporting cyber incidents to DoD. Medium assurance certificates are individually issued digital identity credentials used to ensure the identity of the user in online environments. Certificates typically cost about $175 each. If a contractor submits five cyber incident reports and participates in the voluntary DIB CS program, the annual cost to the contractor is estimated at $1,045. If the contractor elects to receive classified information electronically, the cost to establish the capability is approximately $4,500. The Government incurs cost to collect and analyze cyber incident information and develop trends and other analysis products, analyze malicious software, analyze media, onboard new companies into the voluntary DIB CS information sharing program, and facilitate collaboration activities related to the cyber threat information sharing.

Cybersecurity and Privacy: A foundational element of the mandatory reporting requirements, as well as the voluntary DIB CS program, is the recognition that the information being shared between the parties includes extremely sensitive information that requires protection. For additional information regarding the Government's safeguarding of information received from the contractors that require protection, see the Privacy Impact Assessment (PIA) for DoD's DIB Cybersecurity Activities located at http://dodcio.defense.gov/IntheNews/PrivacyImpactAssessments.aspx. The PIA provides detailed procedures for handling personally identifiable information (PII), attributional information about the strengths or vulnerabilities of specific covered contractor information systems, information providing a perceived or real competitive advantage on future procurement action, and contractor information marked as proprietary or commercial or financial information.

Public Comments

DoD published an interim final rule on October 2, 2015 (80 FR 59581). Twenty-eight comments were received and reviewed by DoD in the development of this final rule. A discussion of the comments received and changes made to the rule as a result of those comments follows:

Comment: One respondent recommended that the rule be clarified to confirm the requirements in the rule are prospective to be implemented in new agreements or in modifying an existing agreement.

Response: There should be no confusion regarding the prospective effect and effective date of the rule, nor is there basis to infer or interpret the rule as being intended to apply retroactively or otherwise to mandate the modification of pre-existing agreements; however, DoD agrees that the rule enables the option to modify such pre-existing agreements where deemed appropriate. No change is made to the rule.

Comment: One respondent expressed concern about being unable to locate the text of Section 941 of the National Defense Authorization Act (NDAA) for Fiscal Year (FY) 2013 in the U.S. Code.

Response: Section 941 of NDAA for FY13 has been codified at 10 U.S.C. 393 and all citations to this law have been updated accordingly.

Comment: One respondent recommended regularly conducting and releasing PIAs.

Response: DoD updates PIAs in accordance with DoD regulations and policy. DoD revised the PIA and published it in October 2015 (see http://dodcio.defense.gov/IntheNews/PrivacyImpactAssessments.aspx). No change is made to the rule.

Comment: Two respondents recommended publishing a report on the program's privacy implications and addressing personal information in internal contractor systems and that DoD address special procedures and protections for personal information.

Response: DIB CS program activities are in compliance with DoD and national policies for collecting, handling, safeguarding, and sharing sensitive information in accordance with DoD Directive 5400.11, “DoD Privacy Program” and 5400.11- Regulation, “Department of Defense Privacy Program,” which prescribes uniform procedures for implementation of and compliance with the DoD Privacy Program. Also, as noted in the immediately preceding response, the PIA for this program is also publicly available at http://dodcio.defense.gov/IntheNews/PrivacyImpactAssessments.aspx. In addition, DoD submits a privacy and civil liberties assessment of the DIB CS voluntary program for the annual Privacy and Civil Liberties Assessment Report required by E.O. 13636. No change is made to the rule.

Comment: One respondent stated that contractors are faced with multiple and sometimes conflicting reporting requirements for reporting cyber incidents from across the Government and even within DoD, and asserts that these reporting requirements should be clearly set forth in agreements with the Government. The respondent did not specifically identify any other cyber incident reporting requirements that might conflict with this rule.

Response: This rule consolidates and streamlines mandatory cyber incident reporting requirements and procedures originating from multiple separate statutory bases (e.g., 10 U.S.C. 391 and 393, and 50 U.S.C. 3330(e))—however, reporting under these procedures in no way abrogates the contractor's responsibility to meet other cyber incident reporting requirements that may be applicable based on other contract requirements, or other U.S. Government statutory or regulatory requirements (see § 236.4(p)). DoD is working to streamline reporting procedures within the Department, including by designating the DoD Cyber Crime Center (DC3) as the single DoD focal point for receiving cyber incident reporting affecting unclassified networks of DoD contractors. No change is made to the rule.

Comment: One respondent recommended that Congress repeal the requirement to establish procedures for mandatory cyber incident reporting.

Response: This rule implements mandatory statutory requirements for mandatory cyber incident reporting set forth in 10 U.S.C. 391 and 393 (§ 236.4(b)-(d)). No change is made to the rule.

Comment: Two respondents questioned the Department's use of specific terms and definitions in the rule. One respondent stated that “a violation of security policy of a system” that is a subset of the definition of “compromise” is very broad and could result in over reporting and overwhelming DoD's resources. Another respondent recommended that the scope of the rule should be narrowed to only information that relates to a “successful penetration.”

Response: The rule leverages established definitions from the Committee on National Security Systems Instruction No. 4009, “National Information (IA) Assurance Glossary,” (https://www.ncsc.gov/nittf/docs/CNSSI-4009_National_Information_Assurance.pdf). The term “successful penetration” is not in the CNSS glossary. However, the rule uses the established terms “cyber incident” and “compromise” from the CNSS glossary, which are widely accepted and understood Government definitions. Adhering to this definition will not overwhelm DoD resources. No change is made to the rule.

Comment: One respondent stated that the four categories of covered defense information are unclear and will hamper timely reporting.

Response: The definition of covered defense information has been clarified to more closely align with, and leverage, the Controlled Unclassified Information (CUI) Registry at http://www.archives.gov/cui/registry/category-list.html (§ 236.2).

Comment: One respondent stated the scope of a cyber incident “affecting the contractor's ability to provide operationally critical support” is so vague that it may result in over reporting.

Response: DoD designates the supplies or services that qualify as operationally critical support, and is developing procedures to ensure that contractors are notified when they are providing supplies or services designated as operationally critical support. If the contractor is unclear as to what specific supplies or services being provided have been designated as operationally critical, the contractor should request clarification from the DoD point of contact (e.g., contracting officer or agreements officer) for the agreement(s) governing the activity in question. No change is made to the rule.

Comment: One respondent stated that it is not clear why the rule now distinguishes information “created by or for DoD” from information “not created by DoD.”

Response: The distinction regarding whether information has been created by or for DoD originates from that distinction being an element of the underlying statutes that are implemented in this rule (e.g., 10 U.S.C. 391 and 393). The distinction is made in a variety of contexts—generally to reinforce the underlying reason for requiring the contractor to share information with DoD (e.g., as it relates to a potential compromise of information created by or for DoD in support of a DoD program), and to minimize the requirement to share or provide access to information that is not related to DoD programs or activities (e.g., except as necessary for forensics analysis regarding an incident in which DoD information may have been compromised). No change is made to the rule.

Comment: One respondent requested clarification of the purpose of, “Applicability and Order of Precedence,” and the meaning of the phrase “applicable laws and regulations” in § 236.4 of this rule.

Response: Section 236.4(a) mandates that the cyber incident reporting requirements of this rule be incorporated into all relevant types of agreements between DoD, but recognizes that in some cases an individual agreement may have terms or conditions that may be inconsistent with this rule, and allows the terms of the agreement to take precedence over the requirements of this rule only when the terms of the agreement “are authorized to have been included in the agreement in accordance with applicable laws and regulations.” The laws and regulations that are applicable to any individual agreement will depend on the nature and context of the agreement. For example, in the context of procurement contracts, the requirements of this rule are implemented through Defense Federal Acquisition Regulation Supplement (DFARS) Subpart 204.73, “Safeguarding Covered Defense Information and Cyber Incident Reporting,” and its associated clauses (e.g., DFARS 252.204-7009, and -7012). However, the FAR and DFARS also permit deviations from otherwise prescribed contract requirements under certain conditions, but not including cases when the deviation would be “precluded by law, executive order, or regulation” (see FAR 1.402). No change is made to the rule.

Comment: One respondent recommended that the phrase “all applicable agreements” in § 236.4(a) be clarified to identify the agreements that DoD intends to be covered by the rule.

Response: Section 236.4(a) has been revised to clarify that the rule applies to “all forms of agreements (e.g., contracts, grants, cooperative agreements, other transaction agreements, technology investment agreements, and any other type of legal instrument or agreement).” For example, these requirements are implemented for DoD procurement contracts through DFARS Subpart 204.73 and its associated clauses (e.g., DFARS 252.204-7009, and -7012).

Comment: One respondent raised issue about the practicality of the 72 hour reporting requirement.

Response: Timeliness in reporting cyber incidents is a key element in cybersecurity and provides the clearest understanding of the cyber threat targeting DoD information and the ability of companies to provide operationally critical support. The 72 hour reporting standard has been a part of the DIB CS program since it was first established as a pilot activity in 2008, and throughout its evolution into a permanent program and ultimate codification in the CFR in 2012. Based on this history, the 72 hour period has proven to be an effective balance of the need for timely reporting while recognizing the challenges inherent in the initial phases of investigating a cyber incident. Contractors should report available information within the 72 hour period and provide updates if more information becomes available. No change is made to the rule.

Comment: One respondent questioned the reporting by subcontractors and how DoD intends to enforce flow down of the clause and does DoD consider Internet Service Providers (ISPs) to fall in the category of subcontractors.

Response: Section 236.4(d) of the rule has been revised to clarify that contractors must flow down the reporting requirements to “subcontractors that are providing operationally critical support or for which subcontract performance will involve a covered contractor information system.” Whether these requirements would be required to flow down to an ISP would depend on whether the particular service(s) being provided would meet the flowdown criteria, and the implementation of these requirements for any specific type of agreement (e.g., for procurement contracts governed by the DFARS) may provide additional guidance regarding flowdown. The contractor should consult with the DoD point of contact for the relevant agreement (e.g., contracting officer or agreements officer) when it is uncertain if the requirements should flow down. Section 236.4(d) has been revised.

Comment: One respondent recommended that the rule establish what information a contractor must share with the Government under mandatory reporting.

Response: Contractors are required to report in accordance with § 236.4(b). A list of the reporting fields can be found at http://dibnet.dod.mil. These reporting fields include the statutory requirements set forth in 10 U.S.C. 391 and 393, including but not limited to an assessment of the impact of the cyber incident, description of the technique or method used, summary of information compromised. No change is made to the rule.

Comment: One respondent commented that the rule does not provide any mechanism for a contractor to raise concerns about, object to, or limit the data being provided due to its sensitivity.

Response: This rule implements mandatory information sharing requirements of 10 U.S.C. 391 and 393 by requiring DoD contractors to report key information regarding cyber incidents, and to provide access to equipment or information enabling DoD to conduct forensic analysis to determine if or how DoD information was impacted in a cyber incident. The rule's implementation of these requirements is tailored to minimize the sharing of unnecessary information (whether sensitive or not), including by carefully tailoring the information required in the initial incident reports (§ 236.4(c)), by expressly limiting the scope of the requirement to provide DoD with access to additional information to only such information that is “necessary to conduct a forensic analysis,” and by affirmatively requiring the Government to safeguard any contractor attributional/proprietary information that has been shared (or derived from information that has been shared) against any unauthorized access or use. In the event that the contractor believes that there is information that meets the criteria for mandatory reporting, but the contractor desires not to share that information due to its sensitivity, then the contractor should immediately raise that issue to the DoD point of contact (e.g., contracting officer or agreements officer) for the agreement(s) governing the activity in question, and if necessary, follow the dispute resolution procedures that are applicable to the agreement(s). No change is made to the rule.

Comment: One respondent asked how DoD will safeguard any contractor data provided as part of media once in DoD's possession, and what are the recourses for contractors in the event of a breach of those safeguards.

Response: DoD uses a wide variety of mechanisms to safeguard all forms of sensitive information, including information received from contractors, to ensure that information is accessed, used, and shared only with authorized persons for authorized purposes. For example, the DIB CS PIA addresses how PII and other sensitive information will be protected. No change is made to the rule.

Comment: One respondent stated that the rule lacks sufficient protections for contractor sensitive information that is provided to government support contractors, and the rule should provide such protections consistent with 10 U.S.C. 2320(f)(2) and DFARS 252.227-7025, “Limitations on the Use or Disclosure of Government-Furnished Information Marked with Restrictive Legends.”

Response: Responsibilities of government support contractors to protect sensitive information received from other contractors under this rule are addressed in § 236.4(m)(5) and are largely consistent with, although not identical to, the statutory provision and DFARS Clause cited by the commenter. In addition, the support contractor providing support for DoD's activities under this rule may also qualify as a “covered Government support contractor” under the cited DFARS clause, and thereby would already be subject to the cited DFARS clause. No change is made to the rule.

Comment: One respondent stated the information shared with the Government should only be used for cybersecurity purposes.

Response: 10 U.S.C. 391 and 393 provide specific authorization for sharing information received in cyber incident reports for a range of important activities that include, but are not limited to, cybersecurity activities (see § 236.4(m)(1)-(5)). Limiting the sharing of information to cybersecurity purposes only would be inconsistent with the statutory framework and would unnecessarily limit the use of information for critical activities such as law enforcement, counterintelligence, and national security. No change is made to the rule.

Comment: One respondent stated the rule provides no limitations on DoD's ability to share information with third-party contractors. It also imposes a confidentiality obligation upon receiving contractors but does not address measures needed to mitigate any potential conflicts of interest stemming from third-party access.

Response: Section 236.4(m)(5) authorizes sharing with government support contractors that are “directly supporting” Government activities under this rule, and applies a comprehensive set of use and non-disclosure restrictions and responsibilities for those government support contractors to safeguard the information they receive, including prohibiting the support contractor from using the information for any other purpose, making the reporting contractor a third-party beneficiary of the non-disclosure agreement with direct remedies for any breach of the restrictions by the support contractor. No change is made to the rule.

Comment: One respondent recommended the proposed rule should establish requirements for companies to remove PII before sharing with the Government and for the Government to remove upon receipt.

Response: The DIB CS program has implemented procedures to minimize the collection and sharing of PII. Companies are always asked to remove unnecessary PII, and only share information if it is relevant to a cyber incident (e.g., for forensics or cyber intrusion damage assessment). The PIA for DoD's DIB CS Activities provides procedures on how the Government handles PII, as well as other forms of sensitive contractor information (e.g., contractor attributional/proprietary). The PIA was updated and published in October 2015 (http://dodcio.defense.gov/IntheNews/PrivacyImpactAssessments.aspx). No change is made to the rule.

Comment: One respondent stated the rule places burden on the contractor to mark information as, “contractor attributional/proprietary,” but if it is not marked and subsequently submitted in response to request for images at the time of the cyber incident, Government must ensure, in absence of marking, obligation to protect information as contractor/attributional/proprietary.

Response: The rule requires that, to the maximum extent practicable, the contractor shall identify and mark attributional/proprietary information, but it does not condition the Government's safeguarding of such information on that identification or marking. The Government has established procedures for receiving, evaluating, anonymizing, safeguarding and sharing of such reported information in connection with cyber incidents involving contractor information and information systems. The DIB CS PIA provides more details regarding processes for handling PII and other sensitive information. No change is made to the rule.

Comment: One respondent stated that the rule should include provisions for liability protection.

Response: Liability protections established by 10 U.S.C. 391 and 393 became effective after the publication of the interim rule. The regulatory implementation of these new statutory elements will be addressed through future rulemaking activities to ensure the opportunity for public comment.

Comment: One respondent recommended expanding the number of commercial service providers under the Enhanced Cybersecurity Service (ECS) program, as part of the DIB CS program.

Response: The ECS program is managed by the Department of Homeland Security (DHS). Recommendations regarding ECS should be forwarded to DHS at [email protected] No change is made to the rule.

Comment: One respondent cautioned against expanding the types of companies eligible for the DIB CS program until addressing all relevant operational, privacy, and security concerns. This expansion could encompass companies who provide services and products to the general public and current defense contractors who are not currently eligible to participate in the program.

Response: DoD has established eligibility requirements (§ 236.7) for participation in the DIB CS program and thus any future expansion or revision of this eligibility criteria will be accomplished in accordance with federal rulemaking requirements to allow for public review and comment. No change is made to the rule.

Comment: One respondent expressed concern about the burden of cost due to increased participation in the DIB CS program.

Response: The burden of cost for companies participating in the DIB CS program has been reduced. Under the revised rule, DoD removed the requirement for DIB CS participants to obtain access to DoD's secure voice and transmission systems supporting the program. All companies participating in the DIB CS program are still required to have a DoD-approved medium assurance certificate to enable encrypted unclassified information sharing between the Government and DIB CS participants. The cost of a DoD-approved medium assurance certificate has not changed and is approximately $175. No change is made to the rule.

Regulatory Procedures Executive Orders 12866, “Regulatory Planning and Review” and 13563, “Improving Regulation and Regulatory Review”

Executive Orders 12866 and 13563 direct agencies to assess all costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, distribute impacts, and equity). Executive Order 13563 emphasizes the importance of quantifying both costs and benefits, of reducing costs, of harmonizing rules, and of promoting flexibility. This rule has been designated a “significant regulatory action,” although not economically significant, under section 3(f) of Executive Order 12866. Accordingly, the rule has been reviewed by the Office of Management and Budget (OMB).

Public Law 104-121, “Congressional Review Act” (5 U.S.C. 801)

It has been determined that this rule is not a “major” rule under 5 U.S.C. 801, enacted by Public Law 104-121, because it will not result in an annual effect on the economy of $100 million or more; a major increase in costs or prices for consumers, individual industries, Federal, State, or local Government agencies, or geographic regions; or significant adverse effects on competition, employment, investment, productivity, innovation, or on the ability of United States-based enterprises to compete with foreign-based enterprises in domestic and export markets.

2 U.S.C. Ch. 25, “Unfunded Mandates Reform Act”

It has been determined that this rule does not contain a Federal mandate that may result in expenditure by State, local and tribal Governments, in aggregate, or by the private sector, of $100 million or more in any one year.

Public Law 96-354, “Regulatory Flexibility Act” (5 U.S.C. Ch. 6)

It has been certified that this rule is not subject to the Regulatory Flexibility Act (5 U.S.C. Ch. 6) because it would not, if promulgated, have a significant economic impact on a substantial number of small entities. Therefore, the Regulatory Flexibility Act, as amended, does not require us to prepare a regulatory flexibility analysis.

Public Law 96-511, “Paperwork Reduction Act” (44 U.S.C. Chapter 35)

This rule does contain reporting requirements under the Paperwork Reduction Act (PRA) of 1995. The collection requirements were published in the preamble of the interim final rule that was published on October 2, 2015 (80 FR 59581) for public comment. No comments were received for these collections. The Office of Management and Budget (OMB) Control Numbers are: 0704-0489, “DoD's Defense Industrial Base (DIB) Cybersecurity (CS) Activities Cyber Incident Reporting,” and 0704-0490, “DoD's Defense Industrial Base (DIB) Cybersecurity (CS) Program Points of Contact (POC) Information.”

Executive Order 13132, “Federalism”

It has been determined that this rule does not have federalism implications, as set forth in Executive Order 13132. This rule does not have substantial direct effects on:

(a) The States;

(b) The relationship between the National Government and the States; or

(c) The distribution of power and responsibilities among the various levels of Government.

List of Subjects in 32 CFR Part 236

Government contracts, Security measures.

Accordingly, the interim final rule published at 80 FR 59581 on October 2, 2015, is adopted as a final rule with the following changes:

PART 236—DEPARTMENT OF DEFENSE (DoD)'s DEFENSE INDUSTRIAL BASE (DIB) CYBERSECURITY (CS) ACTIVITIES 1. The authority citation is revised to read as follows: Authority:

10 U.S.C. 391, 393, and 2224; 44 U.S.C. 3506 and 3544; 50 U.S.C. 3330.

2. Amend § 236.1 by revising the last two sentences in the section to read as follows:
§ 236.1 Purpose.

* * * The part also permits eligible DIB participants to participate in the voluntary DIB CS program to share cyber threat information and cybersecurity best practices with DIB CS participants. The DIB CS program enhances and supplements DIB participants' capabilities to safeguard DoD information that resides on, or transits, DIB unclassified information systems.

3. Amend § 236.2 by: a. Revising the definition of “Covered contractor information system”. b. Revising the definition of “Covered defense information”. c. Revising the definition of “Cyber incident”. d. Revising the definition of “DIB participant”. e. Removing “DoD-DIB CS information sharing program” and adding in its place “DIB CS program” in the definition of “Government furnished information”. f. Removing “Contractor” and adding in its place “contractor” in the definition of “Media”.

The revisions read as follows:

§ 236.2 Definitions.

Covered contractor information system means an unclassified information system that is owned or operated by or for a contractor and that processes, stores, or transmits covered defense information.

Covered defense information means unclassified controlled technical information or other information (as described in the Controlled Unclassified Information (CUI) Registry at http://www.archives.gov/cui/registry/category-list.html) that requires safeguarding or dissemination controls pursuant to and consistent with law, regulations, and Government wide policies, and is:

(1) Marked or otherwise identified in an agreement and provided to the contractor by or on behalf of the DoD in support of the performance of the agreement; or

(2) Collected, developed, received, transmitted, used, or stored by or on behalf of the contractor in support of the performance of the agreement.

DIB participant means a contractor that has met all of the eligibility requirements to participate in the voluntary DIB CS program as set forth in this part (see § 236.7).

§ 236.3 [Amended]
4. Amend § 236.3 by: a. In paragraph (b)(1), removing “DoD-DIB CS information sharing program” and adding in its place “DIB CS program.” b. In paragraph (c), removing “DoD-DIB CS information sharing program” and adding in its place “DIB CS program.”
§ 236.4 [Amended]
5. Amend § 236.4 by: a. In paragraph (a), removing “applicable agreements” and adding in its place “forms of agreements (e.g., contracts, grants, cooperative agreements, other transaction agreements, technology investment agreements, and any other type of legal instrument or agreement).” b. In paragraph (d), removing “, as appropriate” and adding in its place “that are providing operationally critical support or for which subcontract performance will involve a covered contractor information system.” c. In paragraph (e), removing “http://iase.disa.mil/pki/eca/certificate.html” and adding in its place “http://iase.disa.mil/pki/eca/Pages/index.aspx.” d. In paragraph (m)(4), adding “non-attributional cyber threat information” after “sharing.” e. Redesignating paragraphs (n) through (p) as paragraphs (o) through (q). f. Redesignating paragraph (m)(6) as paragraph (n). 6. Amend § 236.5 by: a. Revising the section heading. b. In paragraph (a), removing “DoD-DIB CS information sharing program” and adding in its place “DIB CS program.” c. In paragraph (b), removing “DoD-DIB CS information sharing program” and adding in its place “DIB CS program.” d. Revising paragraph (d). e. In paragraph (g), removing “DoD-DIB CS information sharing program” and adding in its place “DIB CS program.”

The revisions read as follows:

§ 236.5 DoD's DIB CS program.

(d) DoD's DIB CS Program Office is the overall point of contact for the program. The DC3 managed DoD DIB Collaborative Information Sharing Environment (DCISE) is the operational focal point for cyber threat information sharing and incident reporting under the DIB CS program.

7. Amend § 236.6 by: a. Revising the section heading. b. In paragraph (a): i. Removing “DoD-DIB CS information sharing program” and adding in its place “DIB CS program” in the first sentence. ii. Removing “DoD-DIB CS information sharing program” and adding in its place “DIB CS program” in the second sentence. c. In paragraph (c), removing “DoD-DIB CS information sharing program” and adding in its place “DIB CS program.” d. In paragraph (d), removing “DoD-DIB CS information sharing program” and adding in its place “DIB CS program.” e. In paragraph (e), removing “DoD-DIB CS information sharing program” and adding in its place “DIB CS program.” f. In paragraph (g), removing “DoD-DIB CS information sharing program” and adding in its place “DIB CS program.”

The revisions read as follows:

§ 236.6 General provisions of DoD's DIB CS program.
8. Amend § 236.7 by: a. Revising the section heading. b. In paragraph (a) introductory text, removing “DoD-DIB CS information sharing program” and adding in its place “DIB CS program.” c. In paragraph (a)(1), adding “to at least the Secret level” after “FCL.” d. In paragraph (a)(2), removing “DoD-DIB CS information sharing program” and adding in its place “DIB CS program.” e. In paragraph (a)(3)(iii), removing “DoD-DIB CS information sharing program” and adding in its place “DIB CS program.”

The revisions read as follows:

§ 236.7 DoD's DIB CS program requirements.
Dated: September 29, 2016. Patricia L. Toppings, OSD Federal Register, Liaison Officer, Department of Defense.
[FR Doc. 2016-23968 Filed 10-3-16; 8:45 am] BILLING CODE 5001-06-P
DEPARTMENT OF HOMELAND SECURITY Coast Guard 33 CFR Part 100 [Docket Number USCG-2016-0666] RIN 1625-AA08 Special Local Regulation; Ouachita River, Monroe, LA AGENCY:

Coast Guard, DHS.

ACTION:

Temporary final rule.

SUMMARY:

The Coast Guard is establishing a temporary special local regulation controlling movement of vessels for certain waters of the Ouachita River. This rule is necessary to provide for the safety of life on navigable waters during a paddle boat race on October 15, 2016. This regulation requires commercial vessels to notify the Captain of the Port Memphis before entering the event area and require all vessels transiting the area to maintain a minimum speed for safe navigation.

DATES:

This rule is effective on October 15, 2016, from 10 a.m. until 2 p.m.

ADDRESSES:

To view documents mentioned in this preamble as being available in the docket, go to http://www.regulations.gov, type USCG-2016-0666 in the “SEARCH” box and click “SEARCH.” Click on Open Docket Folder on the line associated with this rule.

FOR FURTHER INFORMATION CONTACT:

If you have questions about this rule, call or email Petty Officer Todd Manow, Waterways Management, Sector Lower Mississippi River, U.S. Coast Guard; telephone 901-521-4813, email [email protected]

SUPPLEMENTARY INFORMATION: I. Table of Abbreviations CFR Code of Federal Regulations COTP Captain of the Port DHS Department of Homeland Security E.O. Executive Order FR Federal Register NPRM Notice of proposed rulemaking § Section U.S.C. United States Code II. Background Information and Regulatory History

On May 23, 2016, Louisiana Delta Adventures notified the Coast Guard that it will be conducting a paddle boat race from 10 a.m. to 2 p.m. on October 15, 2016. The paddle boats are to be launched from a boat ramp near mile marker 173.0 at D'Arbonne cutoff in the Ouachita River northwest of West Monroe, LA, and will proceed approximately 7.5 miles downriver to mile maker 166.5 near the Red River Market, Monroe, LA.

The Coast Guard has established special local regulations for similar events and determined that conducting paddle boat races in this portion of navigable waterway, paired with other activities and waterways usage in the area, presents potential safety hazards requiring this regulatory action.

The Coast Guard is issuing this temporary final rule without prior notice and opportunity to comment pursuant to authority under section 4(a) of the Administrative Procedure Act (APA) (5 U.S.C. 553(b)). This provision authorizes an agency to issue a rule without prior notice and opportunity to comment when the agency, for good cause, finds that those procedures are “impracticable, unnecessary, or contrary to the public interest.” Under 5 U.S.C. 553(b)(B), the Coast Guard finds that good cause exists for not publishing a notice of proposed rulemaking (NPRM) with respect to this rule because doing so would be impracticable. Although the event sponsor submitted an initial application for a marine event on May 23, 2016, final details of the event were not known to the Captain of the Port Memphis (COTP) until late August of 2016. This action is necessary to provide for the safety of life on navigable waters during the marine event. It is impracticable to publish an NPRM because we must establish this safety zone by October 15, 2016.

We are issuing this rule, and under 5 U.S.C. 553(d)(3), the Coast Guard finds that good cause exists for making it effective less than 30 days after publication in the Federal Register. For the same reasons discussed in the preceding paragraph, waiting for a 30 day notice period to run would be impracticable.

III. Legal Authority and Need for a Rule

The Coast Guard is issuing this rule under authority in 33 U.S.C. 1233. The COTP has determined that potential hazards posed to participants of a paddle boat race in this section of river would be a safety concern for anyone transiting the river from mile marker 173 to 166.5. The purpose of this rulemaking is to ensure the safety of event participants and other waterway users in U.S. navigable waters within mile marker 173 to 166.5 before, during, and after the scheduled event.

IV. Discussion of the Rule

This rule establishes a special local regulation from 10 a.m. until 2 p.m. on October 15, 2016. In light of the aforementioned hazards, the COTP has determined that a special local regulation is necessary to protect spectators, vessels, and participants. The special local regulation will encompass the following waterway: All waters of the Ouachita River between mile markers 173 and 166.5 in the vicinity of Monroe, LA.

The COTP or a designated on-scene representative will permit vessels to transit the area on a case-by-case basis. Commercial vessel operators desiring to transit through the regulated area must contact the COTP before doing so. The COTP or a designated on-scene representative may be contacted via VHF Channel 16 or by telephone at 1-866-777-2784. During enforcement, all vessels are to proceed at slowest speed for safe navigation while transiting the regulated area.

V. Regulatory Analyses

We developed this rule after considering numerous statutes and Executive orders related to rulemaking. Below we summarize our analyses based on a number of these statutes and Executive orders and we discuss First Amendment rights of protestors.

A. Regulatory Planning and Review

Executive Orders (E.O.) 12866 and 13563 direct agencies to assess the costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits. E.O. 13563 emphasizes the importance of quantifying both costs and benefits, of reducing costs, of harmonizing rules, and of promoting flexibility. This rule has not been designated a “significant regulatory action,” under E.O. 12866. Accordingly, it has not been reviewed by the Office of Management and Budget.

The Coast Guard's use of this special local regulation will be only four hours in duration on a Saturday, and it is designed to minimize the impact on navigation. Moreover, vessels may transit through the area affected by this special local regulation at a minimum speed for safe navigation as approved by the COTP on a case-by-case basis. Overall, the Coast Guard expects minimal impact to vessel movement from the enforcement of this special local regulation.

B. Impact on Small Entities

The Regulatory Flexibility Act of 1980, 5 U.S.C. 601-612, as amended, requires Federal agencies to consider the potential impact of regulations on small entities during rulemaking. The term “small entities” comprises small businesses, not-for-profit organizations that are independently owned and operated and are not dominant in their fields, and governmental jurisdictions with populations of less than 50,000. The Coast Guard certifies under 5 U.S.C. 605(b) that this rule will not have a significant economic impact on a substantial number of small entities.

This rule will affect the following entities, some of which might be small entities: The owners or operators of vessels intending to transit or anchor in this portion of the Ouachita River in the vicinity of Monroe, LA between 10 a.m. and 2 p.m. on October 15, 2016.

Under section 213(a) of the Small Business Regulatory Enforcement Fairness Act of 1996 (Pub. L. 104-121), we want to assist small entities in understanding this rule. If the rule will affect your small business, organization, or governmental jurisdiction and you have questions concerning its provisions or options for compliance, please contact the person listed in the FOR FURTHER INFORMATION CONTACT section. The Coast Guard will not retaliate against small entities that question or complain about this rule or any policy or action of the Coast Guard.

C. Collection of Information

This rule will not call for a new collection of information under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).

D. Federalism and Indian Tribal Governments

A rule has implications for federalism under E.O. 13132, Federalism, if it has a substantial direct effect on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government. We have analyzed this rule under that Order and have determined that it is consistent with the fundamental federalism principles and preemption requirements described in E.O. 13132.

Also, this rule does not have tribal implications under E.O. 13175, Consultation and Coordination with Indian Tribal Governments, because it will not have a substantial direct effect on one or more Indian tribes, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes. If you believe this rule has implications for federalism or Indian tribes, please contact the person listed in the FOR FURTHER INFORMATION CONTACT section.

E. Unfunded Mandates Reform Act

The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538) requires Federal agencies to assess the effects of their discretionary regulatory actions. In particular, the Act addresses actions that may result in the expenditure by a State, local, or tribal government, in the aggregate, or by the private sector of $100,000,000 (adjusted for inflation) or more in any one year. Though this rule will not result in such expenditure, we do discuss the effects of this rule elsewhere in this preamble.

F. Environment

We have analyzed this rule under Department of Homeland Security Management Directive 023-01 and Commandant Instruction M16475.lD, which guide the Coast Guard in complying with the National Environmental Policy Act of 1969 (42 U.S.C. 4321-4370f), and have made a preliminary determination that this action is one of a category of actions that do not individually or cumulatively have a significant effect on the human environment. This rule involves the establishment of a special local regulation lasting four hours. Such actions are categorically excluded from further review under paragraph 34(h) of Figure 2-1 of the Commandant Instruction. An environmental analysis checklist and Categorical Exclusion Determination are available in the docket where indicated under ADDRESSES. We seek any comments or information that may lead to the discovery of a significant environmental impact from this rule.

G. Protest Activities

The Coast Guard respects the First Amendment rights of protesters. Protesters are asked to contact the person listed in the FOR FURTHER INFORMATION CONTACT section to coordinate protest activities so that your message can be received without jeopardizing the safety or security of people, places, or vessels.

List of Subjects in 33 CFR Part 100

Marine safety, Navigation (water), Reporting and recordkeeping requirements, Waterways.

For the reasons discussed in the preamble, the Coast Guard amends 33 CFR part 100 as follows:

PART 100—SAFETY OF LIFE ON NAVIGABLE WATERS 1. The authority citation for part 100 continues to read as follows: Authority:

33 U.S.C. 1233

2. Add § 100.35T08-0666 to read as follows:
§ 100.35T08-0666 Special Local Regulation; Ouachita River; Monroe, LA.

(a) Regulated area. A regulated area is established to encompass the following waterway: all waters of the Ouachita River mile 173 through mile 166.5.

(b) Effective period. This section is effective and will be enforced from 10 a.m. until 2 p.m. on October 15, 2016.

(c) Regulations. (1) In accordance with the general regulations in § 100.801 of this part, commercial vessel operators desiring to operate in the regulated area must contact the Captain of the Port Memphis (COTP) to before doing so. The COTP or a designated representative may be contacted via VHF Channel 16 or by telephone at 1-866-777-2784.

(2) During enforcement, all vessels are to proceed at slowest speed for safe navigation while transiting the regulated area.

(d) Informational broadcasts. The COTP or a designated representative will inform the public through broadcast notices to mariners of the enforcement period for the regulated area as well as any changes in the dates and times of enforcement.

Dated: September 27, 2016. T.J. Wendt, Captain, U.S. Coast Guard, Captain of the Port, Memphis, Tennessee.
[FR Doc. 2016-23973 Filed 10-3-16; 8:45 am] BILLING CODE 9110-04-P
ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 52 [EPA-R06-OAR-2015-0189; FRL-9952-03-Region 6] Promulgation of Air Quality Implementation Plans; State of Arkansas; Regional Haze and Interstate Visibility Transport Federal Implementation Plan Correction

In rule document 2016-22508 beginning on page 66331 in the issue of Tuesday, September 27, 2016, make the following correction:

1. On page 66332, in the first column, after the DATES heading, the second line, “October 27, 2017” should read “October 27, 2016.”

[FR Doc. C1-2016-22508 Filed 10-3-16; 8:45 am] BILLING CODE 1301-00-D
ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 52 [EPA-R09-OAR-2016-0291; FRL-9952-13-Region 9] Approval of California Air Plan Revisions, Sacramento Metropolitan Air Quality Management District and San Diego County Air Pollution Control District AGENCY:

Environmental Protection Agency (EPA).

ACTION:

Direct final rule.

SUMMARY:

The Environmental Protection Agency (EPA) is taking direct final action to approve revisions to the Sacramento Metropolitan Air Quality Management District (SMAQMD) and the San Diego County Air Pollution Control District (SDCAPCD) portions of the California State Implementation Plan (SIP). These revisions concern emissions of volatile organic compounds (VOCs) from architectural coatings. We are approving local rules that regulate these emission sources under the Clean Air Act (CAA or the Act).

DATES:

This rule is effective on December 5, 2016 without further notice, unless the EPA receives adverse comments by November 3, 2016. If we receive such comments, we will publish a timely withdrawal in the Federal Register to notify the public that this direct final rule will not take effect.

ADDRESSES:

Submit your comments, identified by Docket ID No. EPA-R09-OAR-2016-0291 at http://www.regulations.gov, or via email to [email protected] For comments submitted at Regulations.gov, follow the online instructions for submitting comments. Once submitted, comments cannot be edited or removed from Regulations.gov. For either manner of submission, the EPA may publish any comment received to its public docket. Do not submit electronically any information you consider to be Confidential Business Information (CBI) or other information whose disclosure is restricted by statute. Multimedia submissions (audio, video, etc.) must be accompanied by a written comment. The written comment is considered the official comment and should include discussion of all points you wish to make. The EPA will generally not consider comments or comment contents located outside of the primary submission (i.e. on the web, cloud, or other file sharing system). For additional submission methods, please contact the person identified in the FOR FURTHER INFORMATION CONTACT section. For the full EPA public comment policy, information about CBI or multimedia submissions, and general guidance on making effective comments, please visit http://www2.epa.gov/dockets/commenting-epa-dockets.

FOR FURTHER INFORMATION CONTACT:

Arnold Lazarus, EPA Region IX, (415) 972-3024, [email protected]

SUPPLEMENTARY INFORMATION:

Throughout this document, “we,” “us,” and “our” refer to the EPA.

Table of Contents I. The State's Submittal A. What rules did the State submit? B. Are there other versions of these rules? C. What is the purpose of the submitted rules and rule rescission? II. The EPA's Evaluation and Action A. How is the EPA evaluating the rules? B. Do the rules meet the evaluation criteria? C. EPA recommendations to further improve the rules D. Public comment and final action III. Incorporation by Reference IV. Statutory and Executive Order Reviews I. The State's Submittal A. What rules did the State submit?

Table 1 lists the rules addressed by this action with the dates that they were adopted by the local air agencies and submitted by the California Air Resources Board (CARB).

Table 1—Submitted Rules Local agency Rule number Rule title Adopted/
  • amended
  • Repealed/
  • rescinded
  • Submitted
    SDCAPCD 67.0 Architectural Coatings 12/12/01 6/24/15 11/13/15 SDCAPCD 67.0.1 Architectural Coatings 6/24/15 11/13/15 SMAQMD 442 Architectural Coatings 9/24/15 3/11/16

    On April 19, 2016, the EPA determined that the submittal for SMAQMD Rule 442 met the completeness criteria in 40 CFR part 51, appendix V, which must be met before formal EPA review. On January 19, 2016, the EPA determined that the submittals for SDCAPCD Rules 67.0 and 67.0.1 met the completeness criteria.

    B. Are there other versions of these rules?

    There are no previous versions of Rule 67.0.1 in the SIP. We approved earlier versions of Rule 442 into the SIP on November 9, 1998 (63 FR 60214) and Rule 67.0 on June 20, 2013 (78 FR 37130).

    C. What is the purpose of the submitted rules and rule rescission?

    VOCs help produce ground-level ozone, smog and particulate matter (PM), which harm human health and the environment. Section 110(a) of the CAA requires states to submit regulations that control VOC emissions. Architectural coatings are applied to stationary structures and their accessories. They include house paints, stains, industrial maintenance coatings, traffic coatings, and many other products. VOCs are emitted from the coatings during application and curing, and from the associated solvents used for thinning and clean-up. SMAQMD Rule 442 controls VOC emissions from architectural coatings by establishing VOC limits on any architectural coating supplied, sold, offered for sale or manufactured for use within the SMAQMD. Rule 442 was revised to align SMAQMD's architectural coatings practices and VOC limits with those contained in CARB's “2007 Suggested Control Measures for Architectural Coatings” (SCM),1 which are more stringent and make use of newer coating categories than the previous version of Rule 442.

    1http://www.arb.ca.gov/coatings/arch/docs.htm.

    Similarly, SDCAPCD Rule 67.0.1 was adopted to align SDCAPCD's architectural coatings practices and VOC limits with those contained in CARB's SCM. Rule 67.0.1 replaces SDCAPCD Rule 67.0, which was rescinded. SDCAPCD elected to make these changes in a new rule, rather than in revisions to Rule 67.0, “due to the large number of revisions to existing Rule 67.0 that would be necessary to reflect the 2007 SCM.” 2

    2 Letter from Robert J. Kard, Air Pollution Control Officer of the SDCAPCD to the San Diego Air Pollution Control Board, June 24, 2015, p3.

    The EPA's technical support documents (TSDs) have more information about these rules.

    II. The EPA's Evaluation and Action A. How is the EPA evaluating the rules?

    SIP rules must be enforceable (see CAA section 110(a)(2)), must not interfere with applicable requirements concerning attainment and reasonable further progress or other CAA requirements (see CAA section 110(l)), and must not modify certain SIP control requirements in nonattainment areas without ensuring equivalent or greater emissions reductions (see CAA section 193).

    Generally, SIP rules must require Reasonably Available Control Technology (RACT) for each category of sources covered by a Control Techniques Guidelines (CTG) document as well as each major stationary source of VOCs in ozone nonattainment areas classified as moderate or above (see CAA sections 182(b)(2)). The SMAQMD has been designated as severe nonattainment for the 2008 8-hour ozone National Ambient Air Quality Standard (NAAQS). The SDCAPCD regulates an ozone nonattainment area classified as moderate for the 2008 8-Hour Ozone NAAQS (40 CFR 81.305). As addressed further in the TSDs, because there are no relevant EPA CTG documents and because architectural coatings are considered area sources, architectural coating sources are not subject to RACT requirements. However, architectural coating sources are subject to other VOC content limits and control measures described in the TSDs.

    Guidance and policy documents that we use to evaluate enforceability, SIP revision/relaxation and rule stringency requirements for the applicable criteria pollutants include the following:

    1. “State Implementation Plans; General Preamble for the Implementation of Title I of the Clean Air Act Amendments of 1990,” (57 FR 13498, April 16, 1992 and 57 FR 18070, April 28, 1992).

    2. “Issues Relating to VOC Regulation Cutpoints, Deficiencies, and Deviations” (“the Bluebook,” U.S. EPA, May 25, 1988; revised January 11, 1990).

    3. “Guidance Document for Correcting Common VOC & Other Rule Deficiencies” (“the Little Bluebook”, EPA Region 9, August 21, 2001).

    4. “Suggested Control Measure for Architectural Coatings,” CARB, October 2007.

    5. Code of Federal Regulations (CFR), title 40, part 59, subpart D—National Volatile Organic Compound Emission Standards for Architectural Coatings (40 CFR 59.400 et seq.).

    B. Do the rules meet the evaluation criteria?

    We believe these rules and rule rescission are consistent with the relevant policy and guidance regarding enforceability, RACT and SIP relaxations. The TSDs have more information on our evaluation.

    C. EPA Recommendations To Further Improve the Rules

    The TSDs describe additional rule revisions that we recommend for the next time the local agency modifies the rules but which are not currently the basis for rule disapproval.

    D. Public Comment and Final Action

    As authorized in section 110(k)(3) of the Act, the EPA is fully approving the submitted rules and rule rescission because we believe they fulfill all relevant requirements. We do not think anyone will object to this approval, so we are finalizing it without proposing it in advance. However, in the Proposed Rules section of this Federal Register, we are simultaneously proposing approval of the same submitted rules and rule rescission. If we receive adverse comments by November 3, 2016, we will publish a timely withdrawal in the Federal Register to notify the public that the direct final approval will not take effect and we will address the comments in a subsequent final action based on the proposal. If we do not receive timely adverse comments, the direct final approval will be effective without further notice on December 5, 2016. This will incorporate these rules and this rule rescission into the federally enforceable SIP.

    Please note that if the EPA receives adverse comment on an amendment, paragraph, or section of this rule and if that provision may be severed from the remainder of the rule, the EPA may adopt as final those provisions of the rule that are not the subject of an adverse comment.

    III. Incorporation by Reference

    In this rule, the EPA is finalizing regulatory text that includes incorporation by reference. In accordance with requirements of 1 CFR 51.5, the EPA is finalizing the incorporation by reference of the SMAQMD and SDCAPCD rules described in the amendments to 40 CFR part 52 set forth below. The EPA has made, and will continue to make, these documents available through www.regulations.gov and at the EPA Region IX Office (please contact the person identified in the FOR FURTHER INFORMATION CONTACT section of this preamble for more information).

    IV. Statutory and Executive Order Reviews

    Under the Clean Air Act, the Administrator is required to approve a SIP submission that complies with the provisions of the Act and applicable federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a). Thus, in reviewing SIP submissions, the EPA's role is to approve state choices, provided that they meet the criteria of the Clean Air Act. Accordingly, this action merely approves state law as meeting federal requirements and does not impose additional requirements beyond those imposed by state law. For that reason, this action:

    • Is not a significant regulatory action subject to review by the Office of Management and Budget under Executive Orders 12866 (58 FR 51735, October 4, 1993) and 13563 (76 FR 3821, January 21, 2011);

    • does not impose an information collection burden under the provisions of the Paperwork Reduction Act (44 U.S.C. 3501 et seq.);

    • is certified as not having a significant economic impact on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601 et seq.);

    • does not contain any unfunded mandate or significantly or uniquely affect small governments, as described in the Unfunded Mandates Reform Act of 1995 (Public Law 104-4);

    • does not have Federalism implications as specified in Executive Order 13132 (64 FR 43255, August 10, 1999);

    • is not an economically significant regulatory action based on health or safety risks subject to Executive Order 13045 (62 FR 19885, April 23, 1997);

    • is not a significant regulatory action subject to Executive Order 13211 (66 FR 28355, May 22, 2001);

    • is not subject to requirements of Section 12(d) of the National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272 note) because application of those requirements would be inconsistent with the Clean Air Act; and

    • does not provide the EPA with the discretionary authority to address, as appropriate, disproportionate human health or environmental effects, using practicable and legally permissible methods, under Executive Order 12898 (59 FR 7629, February 16, 1994).

    In addition, the SIP is not approved to apply on any Indian reservation land or in any other area where the EPA or an Indian tribe has demonstrated that a tribe has jurisdiction. In those areas of Indian country, the rule does not have tribal implications and will not impose substantial direct costs on tribal governments or preempt tribal law as specified by Executive Order 13175 (65 FR 67249, November 9, 2000).

    The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the Small Business Regulatory Enforcement Fairness Act of 1996, generally provides that before a rule may take effect, the agency promulgating the rule must submit a rule report, which includes a copy of the rule, to each House of the Congress and to the Comptroller General of the United States. The EPA will submit a report containing this action and other required information to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States prior to publication of the rule in the Federal Register. A major rule cannot take effect until 60 days after it is published in the Federal Register. This action is not a “major rule” as defined by 5 U.S.C. 804(2).

    Under section 307(b)(1) of the Clean Air Act, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by December 5, 2016. Filing a petition for reconsideration by the Administrator of this final rule does not affect the finality of this action for the purposes of judicial review nor does it extend the time within which a petition for judicial review may be filed, and shall not postpone the effectiveness of such rule or action. Parties with objections to this direct final rule are encouraged to file a comment in response to the parallel notice of proposed rulemaking for this action published in the Proposed Rules section of this Federal Register, rather than file an immediate petition for judicial review of this direct final rule, so that the EPA can withdraw this direct final rule and address the comment in the proposed rulemaking. This action may not be challenged later in proceedings to enforce its requirements (see section 307(b)(2)).

    List of Subjects in 40 CFR Part 52

    Environmental protection, Air pollution control, Incorporation by reference, Particulate matter, Reporting and recordkeeping requirements, Volatile organic compounds.

    Dated: August 24, 2016. Alexis Strauss, Acting Regional Administrator, Region IX.

    Part 52, chapter I, title 40 of the Code of Federal Regulations is amended as follows:

    PART 52—APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS 1. The authority citation for part 52 continues to read as follows: Authority:

    42 U.S.C. 7401 et seq.

    Subpart F—California 2. Section 52.220 is amended by adding paragraphs (c)(255)(i)(A)(7), (c)(354)(i)(F)(4), (c)(472)(i)(C), and (c)(474)(i)(B) to read as follows:
    § 52.220 Identification of plan.

    (c) * * *

    (255) * * *

    (i) * * *

    (A) * * *

    (7) Previously approved on November 9, 1998, in paragraph (c)(255)(i)(A)(2) of this section and now deleted with replacement in paragraph (c)(474)(i)(B)(1) of this section, Rule 442, adopted on September 5, 1996.

    (354) * * *

    (i) * * *

    (F) * * *

    (4) Previously approved on June 20, 2013, in paragraph (c)(354)(i)(F)(3) of this section and now deleted without replacement, Rule 67.0, “Architectural Coatings,” adopted on December 12, 2001.

    (472) * * *

    (i) * * *

    (C) San Diego Air Pollution Control District.

    (1) Rule 67.0.1, “Architectural Coatings,” adopted on June 24, 2015.

    (474) * * *

    (i) * * *

    (B) Sacramento Metropolitan Air Quality Management District.

    (1) Rule 442, “Architectural Coatings,” amended on September 24, 2015.

    [FR Doc. 2016-23837 Filed 10-3-16; 8:45 am] BILLING CODE 6560-50-P
    ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 52 [EPA-R06-OAR-2013-0465; FRL-9952-82-Region 6] Approval and Promulgation of Air Quality Implementation Plans; Louisiana; Infrastructure State Implementation Plan Requirements for the National Ambient Air Quality Standards AGENCY:

    Environmental Protection Agency (EPA).

    ACTION:

    Final rule.

    SUMMARY:

    The Environmental Protection Agency (EPA) is approving elements of State Implementation Plan (SIP) submittals from Louisiana which address the requirements of Clean Air Act (CAA) sections 110(a)(1) and (2) regarding the infrastructure requirements for the 2006 fine particulate matter (PM2.5), 2008 Lead (Pb), 2008 Ozone (O3), 2010 Nitrogen Dioxide (NO2), 2010 Sulfur Dioxide (SO2) and 2012 PM2.5 National Ambient Air Quality Standards (NAAQS). The infrastructure requirements are designed to ensure that the structural components of each state's air quality management program are adequate to meet the state's responsibilities as defined by the CAA. These infrastructure SIP (i-SIP) submittals address how the existing SIP provides for implementation, maintenance, and enforcement of the NAAQS.

    DATES:

    This rule is effective on November 3, 2016.

    ADDRESSES:

    The EPA has established a docket for this action under Docket ID No. EPA-R06-OAR-2013-0465. All documents in the docket are listed on the http://www.regulations.gov Web site. Although listed in the index, some information is not publicly available, e.g., Confidential Business Information or other information whose disclosure is restricted by statute. Certain other material, such as copyrighted material, is not placed on the Internet and will be publicly available only in hard copy. Publicly available docket materials are available either electronically through http://www.regulations.gov or in hard copy at EPA Region 6, 1445 Ross Avenue, Suite 700, Dallas, Texas 75202-2733.

    FOR FURTHER INFORMATION CONTACT:

    Sherry Fuerst 214-665-6454, [email protected]

    SUPPLEMENTARY INFORMATION:

    Throughout this document, “we,” “us,” and “our” means the EPA.

    I. Background

    The background for this action is discussed in detail in our June 3, 2016 proposal (81 FR 35674). In that rulemaking action, we proposed to approve portions of Louisiana's SIP submittals pertaining to requirements of CAA sections 110(a)(1) and 110(a)(2) of the 2006 PM2.5, 2008 Pb, 2008 O3, 2010 NO2, 2010 SO2 and 2012 PM2.5 NAAQS. CAA Section 110(a)(1) requires states to submit a revised i-SIP within three years after the promulgation of a new or revised NAAQS. The submission must provide for the “implementation, maintenance, and enforcement” of the NAAQS. We received substantive comments from the Sierra Club during the comment period on our Notice of Proposed Rulemaking (NPR). A synopsis of the comments and our responses are provided below.

    II. Response to Comments A. Background Comments 1. The Plain Language of the CAA

    Comment 1: Sierra Club states that the plain language of section 110(a)(2)(A) of the CAA, legislative history of the CAA, case law, EPA regulations, and legislative and regulatory interpretations made previously by EPA in rulemakings require the inclusion of enforceable emission limits in an i-SIP to prevent NAAQS exceedances in areas not designated nonattainment. Sierra Club asserts that EPA must disapprove Louisiana's proposed i-SIP because it is in violation of CAA section 110(a)(2)(A) in that the i-SIP fails to include enforceable emission limitations necessary to ensure attainment and maintenance of the NAAQS. The Commenter also states that the Louisiana i-SIP revision fails to comport with CAA requirements for SIPs to establish enforceable emission limits that are adequate to prohibit NAAQS exceedances in areas not designated nonattainment.

    The Commenter also states that, on its face, the CAA requires i-SIPs “to be adequate to prevent exceedances of the NAAQS.” In support, the Commenter quotes the language in section 110(a)(1) which requires states to adopt a plan for implementation, maintenance, and enforcement of the NAAQS and the language in section 110(a)(2)(A) which the Commenter interprets to require i-SIPs to include enforceable emissions limitations that are sufficient to ensure maintenance of the NAAQS. Sierra Club notes the CAA definition of emission limit and reads these provisions together to require “enforceable emission limits on source emissions sufficient to ensure maintenance of the NAAQS.”

    Response 1: EPA disagrees that section 110 is clear “on its face” and must be read in the manner suggested by Sierra Club in the context of i-SIP submissions. As we have previously explained in response to Sierra Club's similar comments in our previous actions on Virginia's 2008 ozone NAAQS i-SIP (see, 79 FR 17043, 17047 March 27, 2014), Virginia's 2010 SO2 NAAQS i-SIP (see, 80 FR 11557 March 4, 2015), West Virginia's 2010 SO2 i-SIP (see, 79 FR 62022 October 16, 2014), Pennsylvania's 2008 Ozone and 2010 SO2 NAAQS i-SIP (see, 80 FR 46494 August 5, 2015), and New Hampshire's SO2 NAAQS i-SIP (see, 81 FR 44542 July 8, 2016), CAA Section 110 is only one provision that is part of the multi-faceted structure governing implementation of the NAAQS program under the CAA, as amended in 1990, and it must be read in the context of not only that structure, but also of the historical evolution of that structure.

    Infrastructure SIPs are general planning SIPs, consistent with the CAA as understood in light of its history and structure. When Congress enacted the CAA in 1970, it did not include provisions requiring states and the EPA to label areas as attainment or nonattainment. Rather, states were required to include all areas of the state in “air quality control regions” (AQCRs) and section 110 set forth the core substantive planning provisions for these AQCRs. At that time, Congress anticipated that states would be able to address air pollution quickly by complying with the very general planning provisions in section 110 and bring all areas into compliance with a new NAAQS within five years. Moreover, at that time, section 110(a)(2)(A)(i) specified that the section 110 plan provide for “attainment” of the NAAQS and section 110(a)(2)(B) specified that the plan must include “emission limitations, schedules, and timetables for compliance with such limitations, and such other measures as may be necessary to insure attainment and maintenance [of the NAAQS].”

    In 1977, Congress recognized that the existing structure was not sufficient and many areas were still violating the NAAQS. At that time, Congress for the first time added provisions requiring that states and EPA identify whether areas of a state were violating the NAAQS (i.e., were nonattainment) or were meeting the NAAQS (i.e., were attainment/unclassifiable) and established specific planning requirements in section 172 for areas not meeting the NAAQS. In 1990, many areas still had air quality not meeting the NAAQS and Congress again amended the CAA and added yet another layer of more prescriptive planning requirements for each of the NAAQS. At that same time, Congress modified section 110 to remove references to the section 110 SIP providing for attainment, including removing pre-existing section 110(a)(2)(A) in its entirety and renumbering subparagraph (B) as section 110(a)(2)(A). Additionally, Congress replaced the clause “as may be necessary to insure attainment and maintenance [of the NAAQS]” with “as may be necessary or appropriate to meet the applicable requirements of this chapter.” Thus, the CAA has significantly evolved in the more than 40 years since it was originally enacted. While at one time section 110 of the CAA did provide the only detailed SIP planning provisions for states and specified that such plans must provide for attainment of the NAAQS, under the structure of the current CAA, section 110 is only the initial stepping-stone in the planning process for a specific NAAQS. More detailed, later-enacted provisions govern the substantive planning process, including planning for attainment of the NAAQS. CAA section 110 is only one provision that is part of the multi-faceted structure governing implementation of the NAAQS program under the CAA, as amended in 1990, and it must be read in the context of that structure and the historical evolution of that structure. In light of the revisions to section 110 since 1970 and the later-promulgated and more specific planning requirements of the CAA, the requirement in section 110(a)(2)(A) of the CAA that the plan provide for “implementation, maintenance and enforcement” means that the state must demonstrate that it has the necessary tools to implement and enforce a NAAQS, such as adequate state personnel and the legal authority for an enforcement program. It is Part D of title I of the CAA that contains numerous requirements for the NAAQS attainment planning process, including the requirement for enforceable emissions limitations, and such other control measures, means or techniques, as well as schedules and timetables for compliance, as may be necessary or appropriate to provide for the attainment of the NAAQS. After a nonattainment designation is made, the Administrator establishes a plan submission schedule with which the state must comply. The schedule may include submission dates up to three years after the nonattainment designation has been made. The state must, within the schedule provided by the Administrator, submit a plan that meets Part D's requirements. The general requirements of CAA section 110(a)(1) and the listing of elements in CAA section 110(a)(2) require review of each and every provision of a state's existing SIP against all requirements in the CAA and the EPA regulations merely for purposes of assuring that the state in question has the basic structural elements for a functioning SIP for a new or revised NAAQS. The requirement for emission limitations in section 110 means that the state may rely on measures already in place to address the pollutant at issue or any new control measures that the state may choose to submit to meet the requirements in section 110. Finally, as EPA has stated in the 2013 Infrastructure SIP Guidance 1 which specifically provides guidance to states in addressing the 2010 SO2 NAAQS, “[t]he conceptual purpose of an i-SIP submission is to assure that the air agency's SIP contains the necessary structural requirements for the new or revised NAAQS, whether by establishing that the SIP already contains the necessary provisions, by making a substantive SIP revision to update the SIP, or both.” Infrastructure SIP Guidance at p. 1-2.2 Infrastructure SIP submissions are not required to include enforceable emissions limitations and schedules for compliance with the NAAQS, as suggested by the Commenter. Louisiana appropriately demonstrated that it has the “structural requirements” to implement the NAAQS for the pollutants addressed in this rule in its infrastructure SIP submission.

    1 “Guidance on Infrastructure State Implementation Plan (SIP) Elements under Clean Air Act sections 110(a)(1) and 110(a)(2),” Memorandum from Stephen D. Page, September 13, 2013.

    2 Thus, EPA disagrees with Sierra Club's general assertion that the main objective of infrastructure SIPs is to ensure all areas of the country meet the NAAQS, as the infrastructure SIP process is the opportunity to review the structural requirements of a state's air program. EPA, however, does agree with Sierra Club that the NAAQS are the foundation upon which emission limitations are set, as explained in responses to subsequent comments, these emission limitations are generally set in the attainment planning process envisioned by part D of title I of the CAA, including, but not limited to, CAA sections 172 and 191-192.

    2. The Legislative History of the CAA

    Comment 2: Sierra Club cites two excerpts from the legislative history of the 1970 CAA claiming they support an interpretation that SIP revisions under CAA Section 110 must include emissions limitations sufficient to show maintenance of the NAAQS in all areas of Louisiana. Sierra Club also contends that the legislative history of the CAA supports the interpretation that i-SIPs under section 110(a)(2) must include enforceable emission limitations, citing the Senate Committee Report and the subsequent Senate Conference Report accompanying the 1970 CAA.

    Response 2: As noted above, the CAA, as enacted in 1970, including its legislative history, cannot be read in isolation from the later amendments that refined that structure and deleted relevant language from CAA Section 110 concerning demonstrating attainment. See also, 79 FR at 17043, 80 FR 11557, 79 FR 62022, 80 FR 46494 (responding to comments on various other i-SIPs). In any event, the two excerpts of legislative history the Sierra Club cites merely provide that states should include enforceable emission limits in their SIPs and they do not mention or otherwise address whether states are required to impose additional emission limitations or control measures as part of the i-SIP submission, as opposed to requirements for other types of SIP submissions such as attainment plans required under section 110(a)(2)(I). The proposed rule and the Technical Support Document (TSD) for it explain why the Louisiana SIP includes sufficient enforceable emissions limitations for the purposes of the infrastructure SIP submission.

    3. Case Law

    Comment 3: Sierra Club also cites to several cases which have interpreted various parts of the CAA. Sierra Club claims these cases support their contention that section 110(a)(2)(A) requires i-SIPs submissions to contain enforceable emissions limits in order to prevent exceedances of the NAAQS in areas not designated nonattainment. Sierra Club first cites to language in Train v. NRDC, 421 U.S. 60, 78 (1975), addressing the requirement for “emission limitations” and stating that emission limitations “are specific rules to which operators of pollution sources are subject, and which, if enforced, should result in ambient air which meet the national standards.” Sierra Club also cites to Pennsylvania Dept. of Envtl. Resources v. EPA, 932 F.2d 269, 272 (3d Cir. 1991) for the proposition that the CAA directs EPA to withhold approval of a SIP where it does not ensure maintenance of the NAAQS, and to Mision Industrial, Inc. v. EPA, 547 F.2d 123, 129 (1st Cir. 1976), which quoted section 110(a)(2)(B) of the CAA of 1970. The commenter states that the 1990 Amendments do not alter how courts have interpreted the requirements of section 110, quoting Alaska Dept. of Envtl. Conservation v. EPA, 540 U.S. 461, 470 (2004) which in turn quoted section 110(a)(2)(A) of the CAA and also stated that “SIPs must include certain measures Congress specified” to ensure attainment of the NAAQS. The Commenter also quotes several additional opinions in this vein. Mont. Sulphur & Chem. Co. v. EPA, 666 F.3d 1174, 1180 (9th Cir. 2012) (“The Clean Air Act directs states to develop implementation plans—SIPs—that `assure' attainment and maintenance of [NAAQS] through enforceable emissions limitations”); Hall v. EPA 273 F.3d 1146, 1153 (9th Cir. 2001) (“Each State must submit a [SIP] that specif[ies] the manner in which [NAAQS] will be achieved and maintained within each air quality control region in the State”); Conn. Fund for Env't, Inc. v. EPA, 696 F.2d 169, 172 (D.C. Cir. 1982) (CAA requires SIPs to contain “measures necessary to ensure attainment and maintenance of NAAQS”). Finally, Sierra Club cites Mich. Dept. of Envtl. Quality v. Browner, 230 F.3d 181 (6th Cir. 2000) for the proposition that EPA may not approve a SIP revision that does not demonstrate how the rules would not interfere with attainment and maintenance of the NAAQS.

    Response 3: None of the cases Sierra Club cites support its contention that section 110(a)(2)(A) requires i-SIP submissions to include detailed plans providing for attainment and maintenance of the NAAQS in all areas of the state, nor do they shed light on the present day requirements of section 110(a)(2)(A). With the exception of Train, none of the cases the Commenter cites specifically concerned the interpretation of CAA section 110(a)(2)(A) (or section 110(a)(2)(B) of the pre-1990 Act). Rather, the courts reference section 110(a)(2)(A) (or section 110(a)(2)(B) of the pre-1990 CAA) in the background sections of decisions in the context of a challenge to an EPA action on revisions to a SIP that were required and approved as meeting other provisions of the CAA or in the context of an enforcement action.

    In Train, the Court was addressing a state revision to an attainment plan submission made pursuant to section 110 of the CAA, the sole statutory provision at that time addressing such submissions. The issue in that case concerned whether changes to requirements that would occur before attainment was required were variances that should be addressed pursuant to the provision governing SIP revisions or were “postponements” that must be addressed under section 110(f) of the CAA of 1970, which contained prescriptive criteria. The Court concluded that EPA reasonably interpreted section 110(f) not to restrict a state's choice of the mix of control measures needed to attain the NAAQS, so long as the state met other applicable requirements of the CAA, and that revisions to SIPs that would not impact attainment of the NAAQS by the attainment date were not subject to the limits of section 110(f). Thus the issue was not whether the specific SIP at issue needs to provide for attainment or whether emissions limits are needed as part of the SIP; rather the issue was which statutory provision governed when the state wanted to revise the emission limits in its SIP if such revision would not impact attainment or maintenance of the NAAQS.

    Pennsylvania Dept. of Envtl. Resources was also decided based on the pre-1990 provision of the CAA. At issue was whether EPA properly rejected a revision to an approved SIP where the inventories relied on by the state for the updated submission had gaps. The Court quoted section 110(a)(2)(B) of the pre-1990 CAA in support of EPA's disapproval, but did not provide any interpretation of that provision. This decision did not address the question at issue in this action, i.e., what a state must include in an i-SIP submission for the purposes of section 110(a)(2)(A).Yet, even if the Court had interpreted that provision, EPA notes that it was modified by Congress in 1990; thus, this decision has little bearing on the present issue here.

    At issue in Mision Industrial, was the definition of “emissions limitation”, not whether section 110 requires the State to demonstrate how all areas of the State will attain and maintain the NAAQS as part of the State's i-SIP submission. The language from the opinion the Commenter quotes does not interpret but rather merely describes section 110(a)(2)(A). Sierra Club does not raise any concerns about whether the measures relied on by the State in the i-SIP submission are “emissions limitations” within the definition provided by the Act and the decision in this case has no bearing here.3

    3 While Sierra Club does contend that the State shouldn't be allowed to rely on emission reductions that were developed for the prior SO2 standards (which we address herein), it does not claim that any of the measures are not “emissions limitations” within the definition of the CAA.

    In Mont. Sulphur & Chem. Co., 666 F.3d 1174, the Court was reviewing a federal implementation plan (FIP) that EPA promulgated after a long history of the State failing to submit an adequate SIP in response to EPA's finding under section 110(k)(5) that the previously approved SIP was substantially inadequate to attain or maintain the NAAQS, which triggered the State's duty to submit a new SIP detailing how it would remedy that deficiency and the measures that would be put in place to attain the NAAQS. The Court cited generally to sections 107 and 110(a)(2)(A) of the CAA for the proposition that SIPs should assure attainment and maintenance of NAAQS through emission limitations, but this language was not part of the Court's holding in the case. The holding in Mont. Sulphur focused on whether EPA's finding of SIP inadequacy, disapproval of the State's responsive attainment demonstration, and adoption of a remedial FIP were lawful.

    The Commenter suggests that Alaska Dept. of Envtl. Conservation, 540 U.S. 461, stands for the proposition that the 1990 CAA Amendments do not alter how courts interpret section 110. This claim is inaccurate. Rather, the Court quoted section 110(a)(2)(A), which, as noted previously, differs from the pre-1990 version of that provision and the court makes no mention of the changed language. Furthermore, Sierra Club also quotes the Court's statement that “SIPs must include certain measures Congress specified,” but that statement specifically referenced the requirement in section 110(a)(2)(C), which requires an enforcement program and a program for the regulation of the modification and construction of any stationary sources. Notably, at issue in that case was the State's “new source” permitting program, not what is required for an i-SIP submission for purposes of CAA section 110(a)(2)(A).

    Two of the cases Sierra Club cites, Mich. Dept. of Envtl. Quality, 230 F.3d 181, 183, 185 and Hall, 273 F.3d 1146, 1153 interpret CAA section 110(l), the provision governing “revisions” to plans, and not the initial plan submission requirement under section 110(a)(2) for a new or revised NAAQS, such as the i-SIP submissions at issue in this instance. Neither case, however, addressed the question at issue here, i.e., what states are required to address for purposes of an infrastructure SIP submission for purposes of section 110(a)(2)(A).

    Finally, in Conn. Fund for Env't, Inc. v. EPA, the D.C. Circuit was reviewing EPA action on a control measure SIP provision which adjusted the percent of sulfur permissible in fuel oil. 696 F.2d 169 (D.C. Cir. 1982). The D.C. Circuit focused on whether EPA needed to evaluate effects of the SIP revision on one pollutant or effects of changes on all possible pollutants; therefore, the D.C. Circuit did not address required measures for i-SIPs and nothing in the opinion addressed whether i-SIP submissions need to contain measures to ensure attainment and maintenance of the NAAQS.

    EPA's position is that none of these court cases addressed required measures for i-SIP submission and therefore nothing in the opinions addressed whether the state's i-SIP submission must contain measures to ensure attainment and maintenance of the NAAQS.

    4. EPA Regulations, Such as 40 CFR 51.112(a)

    Comment 4: Sierra Club cites to 40 CFR 51.112(a), which provides that “[e]ach plan must demonstrate that the measures, rules and regulations contained in it are adequate to provide for the timely attainment and maintenance of the [NAAQS].” Sierra Club asserts that this regulation requires all SIPs to include emissions limits necessary to ensure attainment of the NAAQS. Sierra Club states that “[a]lthough these regulations were developed before the Clean Air Act separated i-SIPs from nonattainment SIPs—a process that began with the 1977 amendments and was completed by the 1990 amendments—the regulations apply to [i]-SIPs.” Sierra Club relies on a statement in the preamble to the 1986 action restructuring and consolidating provisions in part 51, in which EPA stated that “[i]t is beyond the scope of th[is] rulemaking to address the provisions of Part D of the Act . . .” 51 FR 40656, 40656 (November 7, 1986).

    Response 4: Sierra Club's reliance on 40 CFR 51.112 to support its argument that i-SIPs must contain emission limits “adequate to prohibit NAAQS exceedances” and adequate or sufficient to ensure the maintenance of the NAAQS is incorrect. As an initial matter, EPA notes and the Sierra Club recognizes this regulatory provision was initially promulgated and “restructured and consolidated” prior to the CAA Amendments of 1990, in which Congress removed all references to “attainment” in section 110(a)(2)(A). And, it is clear that 40 CFR 51.112 directly applies to state SIP submissions that are specifically required to attain the NAAQS in nonattainment areas. These regulatory requirements apply when states are developing “control strategy” SIPs under other provisions of the CAA, such as attainment plans required for various NAAQS in Part D and maintenance plans required in section 175A. Sierra Club's suggestion that these provisions must apply to section 110 i-SIPs because in the preamble to EPA's action “restructuring and consolidating” provisions in part 51, we stated that the new attainment demonstration provisions in the 1977 Amendments to the CAA were “beyond the scope” of the rulemaking.4

    4 It is important to note, however, that EPA's action in 1986 was not to establish new substantive planning requirements, but rather was meant merely to consolidate and restructure provisions that had previously been promulgated. EPA noted that it had already issued guidance addressing the new “Part D” nonattainment planning obligations. Also, as to maintenance regulations, EPA expressly stated that it was not making any revisions other than to re-number those provisions. 51 FR at 40657.

    Although EPA was explicit that it was not establishing requirements interpreting the provisions of new “Part D” of the CAA, it is clear that the regulations being restructured and consolidated were intended to address control strategy plans. In the preamble, EPA clearly stated that 40 CFR 51.112 was replacing 40 CFR 51.13 (“Control strategy: SOX and PM (portion)”), 51.14 (“Control strategy: CO, HC, OX and NO2 (portion)”), 51.80 (“Demonstration of attainment: Pb (portion)”), and 51.82 (“Air quality data (portion)”). Id. at 40660. Thus, the present-day 40 CFR 51.112 contains consolidated provisions that are focused on control strategy SIPs, and the i-SIP is not such a plan.

    5. EPA Interpretations in Other Rulemakings

    Comment 5: Sierra Club also references two prior EPA rulemaking actions where EPA disapproved or proposed to disapprove SIPs and claimed these were actions in which EPA relied on section 110(a)(2)(A) and 40 CFR 51.112 to reject i-SIPs. The Sierra Club first points to a 2006 partial approval and partial disapproval of revisions to Missouri's existing plan addressing the SO2 NAAQS. In that action, EPA cited section 110(a)(2)(A) as the basis disapproving a revision to the state plan on the basis that the State failed to demonstrate the SIP was sufficient to ensure maintenance of the SO2 NAAQS after revision of an emission limit. EPA also cited to 40 CFR 51.112, stating it requires that a plan demonstrates the rules in a SIP are adequate to attain the NAAQS. Second, Sierra Club cites a 2013 disapproval of a revision to the SO2 SIP for Indiana, where the revision removed an emission limit that applied to a specific emissions source at a facility in the State. See, 78 FR 17157, 17158 (March 20, 2013) (proposed rule on Indiana SO2 SIP) and 78 FR 78720, 78721 (December 27, 2013) (final rule on Indiana SO2 SIP). In its proposed disapproval, EPA relied on 40 CFR 51.112(a) in proposing to reject the revision, stating that the State had not demonstrated that the emission limit was “redundant, unnecessary, or that its removal would not result in or allow an increase in actual SO2 emissions.” EPA further stated in that proposed disapproval that the State had not demonstrated that removal of the limit would not “affect the validity of the emission rates used in the existing attainment demonstration.”

    Response 5: EPA does not agree that the two prior actions referenced by Sierra Club establish how EPA reviews i-SIP submissions. It is clear from both the final Missouri rule and the proposed and final Indiana rule that EPA was not reviewing initial i-SIP submissions under section 110 of the CAA, but rather reviewing revisions that would make an already approved SIP designed to demonstrate attainment of the NAAQS less stringent. EPA's partial approval and partial disapproval of revisions to restrictions on emissions of sulfur compounds for the Missouri SIP in 71 FR 12623 addressed a control strategy SIP submission, and not an i-SIP submission. The Indiana action provides even less support for the Sierra Club's position since the EPA was reviewing a completely different requirement than that listed in CAA section 110(a)(2)(A). Rather, in that case, the State had an approved SO2 attainment plan which already included a specific emissions limitation for sources and was seeking to remove provisions from the SIP that it relied on as part of the modeled attainment demonstration. See, 78 FR 78720. EPA proposed that the State had failed to demonstrate under section 110(l) of the CAA that the SIP revision would not result in increased SO2 emissions and thus would interfere with attainment of the NAAQS. See, 78 FR 17157. Nothing in that proposed or final rulemaking addresses the necessary content of the initial i-SIP submission for a new or revised NAAQS. Rather, it is simply applying the clear statutory requirement that a state must demonstrate why a revision to an approved attainment plan will not interfere with attainment of the NAAQS.

    As discussed in detail in the TSD and proposed rule, EPA finds the Louisiana SIP meets the appropriate and relevant structural requirements of section 110(a)(2) of the CAA, that it will aid in attaining and/or maintaining the NAAQS, and that the State demonstrated that it has the necessary tools to implement and enforce the NAAQS.

    Comments on Louisiana SIP Emission Limits

    Comment 6: Citing section 110(a)(2)(A) of the CAA, Sierra Club contends that EPA may not approve Louisiana's proposed i-SIP because it does not include enforceable NAAQS, including a 1-hour SO2 emission limit, for sources that they claim are currently allowed to cause “NAAQS exceedances.” Sierra Club also asserts the proposed i-SIP fails to include other required measures to ensure attainment and maintenance of the NAAQS in areas not designated nonattainment as Sierra Club claims is required by section 110(a)(2)(A). Sierra Club argues that an i-SIP must ensure, through state-wide regulations or source specific requirements, proper mass limitations and short term averaging on specific large sources of pollutants such as power plants. Sierra Club states that emission limits are especially important for meeting the 1-hour SO2 NAAQS because SO2 impacts are strongly source-oriented. Sierra Club states coal-fired electric generating units (EGUs) are large contributors to SO2 emissions, but contends Louisiana did not demonstrate that emissions allowed by the proposed i-SIP from such large sources of SO2 will ensure compliance with the 2010 1-hour SO2 NAAQS. They stated that the proposed i-SIP would allow major sources to continue operating with present emission limits. Sierra Club then refers to air dispersion modeling it conducted for two coal-fired EGUs in Louisiana, Cleco Power's Dolet Hills Power Station and Entergy's Big Cajun II Generating Station. Further, Sierra Club claims that the results of the air dispersion modeling it conducted employing EPA's AERMOD program for modeling used the plants' allowable and maximum emissions and showed the plants could cause exceedances of the 2010 SO2 NAAQS with either allowable or maximum emissions.5 Based on the modeling, Sierra Club claims the Louisiana's SO2 i-SIP submittal authorizes the two EGUs to cause exceedances of the NAAQS with allowable and maximum emission rates and therefore the i-SIP fails to include adequate enforceable emission limitations or other required measures for sources of SO2 sufficient to ensure attainment and maintenance of the 2010 SO2 NAAQS. Sierra Club therefore asserts EPA must disapprove Louisiana's proposed SIP revision. In addition, Sierra Club asserts “EPA must impose additional emission limits on the plants that ensure attainment and maintenance of the NAAQS at all times.”

    5 Sierra Club asserts its modeling followed protocols pursuant to 40 CFR part 50, Appendix W and EPA's 2011 Guideline on implementing the one-hour SO2 NAAQS.

    Response 6: As explained in previous responses above, section 110(a)(2)(A) of the CAA requires states to submit i-SIPs that reflect the first step in their planning for attainment and maintenance of a new or revised NAAQS. These i-SIP revisions should contain a demonstration that the state has the available tools and authority to develop and implement plans to attain and maintain the NAAQS and show that the SIP has enforceable control measures. In light of the structure of the CAA, EPA's long-standing position regarding i-SIPs is that they are general planning SIPs to ensure that the state has adequate resources and authority to implement a NAAQS in general throughout the state. These i-SIP submissions are not detailed attainment and maintenance plans for each individual area of the state. States may rely on measures already in place to address the pollutant at issue or any new control measures that the state may choose to submit.

    As stated in response to a previous comment, EPA asserts that section 110 of the CAA is only one provision that is part of the multi-faceted structure governing implementation of the NAAQS program under the CAA, as amended in 1990, and it must be read in the context of not only that structure, but also of the historical evolution of that structure. In light of the revisions to CAA section 110 since 1970 and the later-promulgated and more specific planning requirements of the CAA, section 110(a)(2)(A) does not require that an i-SIP contain enforceable emissions limits that will aid in attaining and/or maintaining the NAAQS. The i-SIPs required by CAA section 110(a) are not the appropriate place to require emission limits demonstrating future attainment with a NAAQS. Part D of title I of the CAA contains numerous requirements for the NAAQS attainment planning process. These requirements include enforceable emissions limitations, and such other control measures, means or techniques, as well as schedules and timetables for compliance, as may be necessary or appropriate to provide for the attainment of the NAAQS. States have up to three years from the date of a nonattainment designation to submit a SIP meeting Part D's requirements. Louisiana's submittal was submitted to comply with the requirements outlined in CAA section 110(a), not Part D. As discussed above, the state may rely on measures already in place to address the pollutant at issue or any new control measures that the state may choose to submit. Finally, as EPA stated in the Infrastructure SIP Guidance, which specifically provides guidance to states in addressing the NAAQS, “[t]he conceptual purpose of an i-SIP submission is to assure that the air agency's SIP contains the necessary structural requirements for the new or revised NAAQS, whether by establishing that the SIP already contains the necessary provisions, by making a substantive SIP revision to update the SIP, or both.” 2013 Infrastructure SIP Guidance at p. 2.

    On April 12, 2012, EPA explained its expectations regarding the 2010 SO2 NAAQS via letters to each of the states. EPA communicated in the April 2012 letters that all states were expected to submit SIPs meeting the “infrastructure” SIP requirements under section 110(a)(2) of the CAA by June 2013. At the time, EPA was undertaking a stakeholder outreach process to continue to develop possible approaches for determining attainment status under the SO2 NAAQS and implementing this NAAQS. EPA was abundantly clear in the April 2012 letters that EPA did not expect states to submit substantive attainment demonstrations or modeling demonstrations showing attainment for areas not designated nonattainment in i-SIP submission due in June 2013. Although EPA had previously suggested in its 2010 SO2 NAAQS preamble and in prior draft implementation guidance in 2011 that states should, in the unique SO2 context, use the section 110(a) SIP process as the vehicle for demonstrating attainment of the NAAQS, this approach was never adopted as a binding requirement and was subsequently discarded in the April 2012 letters to states. The April 2012 letters recommended states focus i-SIPs due in June 2013, such as Louisiana's SO2 i-SIP submission, on traditional “infrastructure elements” in section 110(a)(1) and (2), rather than on modeling demonstrations for future attainment for areas not designated as nonattainment. In February of 2016, EPA issued non-binding guidance for states to use in conducting, if they choose, additional analysis to support designations for the 2010 1-hour SO2 NAAQS. SO 2 NAAQS Designations Modeling Technical Assistance Document, EPA Office of Air and Radiation and Office of Air Quality Planning and Standards, February 2016, available at https://www.epa.gov/so2-pollution/technical-assistance-documents-implementing-2010-sulfur-dioxide-standard.

    Therefore, EPA asserts that SIP revisions for SO2 nonattainment areas including measures and modeling demonstrating attainment are due by the dates statutorily prescribed under subpart 5 under part D of Title I of CAA. Those submissions are due no later than 18 months after an area is designed nonattainment for SO2, under CAA section 191(a). Thus, the CAA directs states to submit these SIP requirements for nonattainment areas on a separate schedule from the “structural requirements” of 110(a)(2) which are due within three years of adoption or revision of a NAAQS. The i-SIP submission requirement does not move up the date for any required submission of a CAA Title I part D plan for areas designated nonattainment for the new NAAQS. Thus, elements relating to demonstrating attainment for areas not attaining the NAAQS are not required for i-SIP submissions, and the CAA does not provide explicit requirements for demonstrating attainment for areas that have not yet been designated regarding attainment with a particular NAAQS.

    The proper inquiry at this juncture is whether Louisiana has met the basic structural SIP requirements applicable at the point in time that the SIP was submitted. Emissions limitations and other control measures needed to attain the NAAQS in areas designated nonattainment for that NAAQS are due on a different schedule from the section 110 infrastructure elements. A state, like Louisiana, may choose to reference pre-existing SIP emission limits approved by EPA as meeting CAA Title I of part D plans for previous NAAQS in an i-SIP submission for purposes of CAA section 110(a)(2)(A).

    The requirements for emission reduction measures for an area designated nonattainment for the 2010 primary SO2 NAAQS are in sections 172 and 191-192 of the CAA, and therefore, the appropriate avenue for implementing requirements for necessary emission limitations for demonstrating attainment with the 2010 SO2 NAAQS is through the attainment planning process contemplated by those sections of the CAA. LDEQ is required to bring St. Bernard Parish into compliance with the 1-hour standard as expeditiously as practicable, but no later than, October 4, 2018. The appropriate time for examining necessity of emission limits on specific sources is within the attainment planning process. When the St. Bernard Parish SO2 attainment demonstration is submitted by the State, EPA will take action on it in a separate rulemaking. In separate future actions, EPA intends to address the designations for all other areas for which EPA has yet to issue designations. See, e.g., 79 FR 27446 (May 13, 2014) (proposing process and timetables by which state air agencies would characterize air quality around SO2 sources through ambient monitoring and/or air quality modeling techniques and submit such data to the EPA). As previously stated, EPA's position is that the submitted i-SIPs should be evaluated on whether Louisiana has met the basic structural SIP requirements applicable at the point in time that the SIP was submitted. Utilizing the i-SIP process to require the substantive elements contained elsewhere in the CAA, as detailed above, would be disruptive and premature absent exceptional circumstances and would interfere with a state's planning process. See, In the Matter of EME Homer City Generation LP and First Energy Generation Corp., Order on Petitions Numbers III-2012-06, III-2012-07, and III-2013-01 (July 30, 2014) (hereafter, Homer City/Mansfield Order) at 10-19 (finding Pennsylvania SIP did not require imposition of SO2 emission limits on sources independent of the part D nonattainment planning process contemplated by the CAA). The history of the CAA, and intent of Congress for the CAA as described above, demonstrate clearly that it is within the section 172 and general part D nonattainment planning process that Louisiana must include additional SO2 emission limits on sources in order to demonstrate future attainment, where needed, for any areas in Louisiana or other states that may be designated nonattainment now or in the future, in order to attain the 2010 1-hour SO2 or other NAAQS.

    Sierra Club's reliance on 40 CFR 51.112 to support its argument that i-SIPs must contain emission limits adequate to provide for timely attainment and maintenance of the standard is also unsupported. As explained above, EPA notes this regulatory provision clearly applies to plans specifically designed to attain the NAAQS and not to i-SIPs which show the states have in place structural requirements necessary to implement the NAAQS. Therefore, EPA finds 40 CFR 51.112 inapplicable to its analysis of Louisiana's i-SIP submission.

    Regarding the air dispersion modeling conducted by Sierra Club pursuant to AERMOD for the coal-fired EGUs, including Cleco Power's Dolet Hills Power Station and Entergy's Big Cajun II Generating Station, EPA is not in this action making a determination regarding the air quality status in the area where these EGUs are located, and is not evaluating whether emissions applicable to these EGUs are adequate to attain and maintain the NAAQS. Consequently, EPA does not find the modeling information relevant for review of an infrastructure SIP for purposes of section 110(a)(2)(A). When additional areas in Louisiana are designated under the 2010 1-hour SO2 NAAQS, and if any additional areas in Louisiana are designated nonattainment in the future, any potential future modeling submitted by the State with designations or attainment demonstrations would need to account for any new emissions limitations Louisiana develops to support such designation or demonstration. While EPA has extensively discussed the use of modeling for attainment demonstration purposes and for designations, EPA has recommended that such modeling was not needed for the SO2 infrastructure SIPs for the 2010 1-hour SO2 NAAQS for purposes of section 110(a)(2)(A), which are not actions in which EPA makes determinations regarding current air quality status.6 See April 12, 2012, letters to states and 2012 Draft White Paper.

    6See, for example, EPA recently discussed modeling for characterizing air quality in the Agency's August 21, 2015, final rule at 80 FR 51052 and for nonattainment planning in the April 23, 2014, Guidance for 1-Hour SO 2 Nonattainment Area SIP Submissions, Stephen D. Page, Director, EPA's Office of Air Quality Planning and Standards, to Regional Air Division Directors Regions 1-10, April 23, 2014, available at https://www.epa.gov/sites/production/files/2016-06/documents/20140423guidance_nonattainment_sip.pdf.

    In conclusion, EPA disagrees with Sierra Club's assertions that EPA must disapprove Louisiana's i-SIP submission because it does not establish specific enforceable NAAQS emission limits, and specifically enforceable emission limits for SO2, either on coal-fired EGUs or other large SO2 sources, in order to demonstrate attainment and maintenance with the NAAQS.

    Comment 7: Sierra Club asserts that modeling is the appropriate tool for evaluating adequacy of i-SIPs and ensuring attainment and maintenance of the 2010 SO2 NAAQS. The Commenter refers to EPA's historic use of air dispersion modeling for attainment designations as well as “SIP revisions.” The Commenter states that in prior EPA statements the Agency has said it used modeling for designations and attainment demonstrations, including statements in the 2010 SO2 NAAQS preamble, EPA's 2012 Draft White Paper for Discussion on Implementing the 2010 SO2 NAAQS, and a 1994 SO2 Guideline Document, as modeling could better address the source-specific impacts of SO2 emissions and historic challenges from monitoring SO2 emissions.

    The Commenter discusses statements made by EPA staff regarding (1) the use of modeling and monitoring in setting emission limitations, (2) determining ambient concentrations as a result of a source's emissions, (3) discussing performance of AERMOD as a model, including if AERMOD is capable of predicting whether the NAAQS is attained, and (4) whether individual sources contribute to SO2 NAAQS violations. Sierra Club cites to EPA's history of employing air dispersion modeling for increment compliance verifications in the permitting process for the Prevention of Significant Deterioration (PSD) program which is required in part C of title I of the CAA.

    Sierra Club asserts EPA's use of air dispersion modeling was upheld in GenOn REMA, LLC v. EPA, 722 F.3d 513 (3rd Cir. 2013) where an EGU challenged EPA's use of CAA section 126 to impose SO2 emission limits on a source due to cross-state impacts. The Commenter claims the Third Circuit in GenOn REMA upheld EPA's actions after examining the record which included EPA's air dispersion modeling of the one source as well as other data.

    The Commenter cites to Vehicle Mfrs. Ass'n v. State Farm Mut. Auto Ins. Co., 463 U.S. 29, 43 (1983) and NRDC v. EPA, 571 F.3d 1245, 1254 (D.C. Cir. 2009) for the general proposition that it would be arbitrary and capricious for an agency to ignore an aspect of an issue placed before it and that an agency must consider information presented during notice-and-comment rulemaking.

    Finally, Sierra Club claims that Louisiana's proposed i-SIP lacks emission limitations informed by air dispersion modeling and therefore fails to ensure Louisiana will achieve and maintain the SO2 NAAQS. Sierra Club claims EPA must require adequate, 1-hour SO2 emission limits in the i-SIP that show no exceedances of NAAQS when modeled.

    Response 7: EPA agrees with Sierra Club that air dispersion modeling, including the use of AERMOD, can be an important tool for SO2 designations under CAA section 107, and also as part of attainment planning under CAA sections 172 and 191-192. EPA agrees that prior EPA statements, EPA guidance, and case law support the use of air dispersion modeling in the SO2 designations process and attainment demonstration SIP process, as well as in analyses of whether existing approved SIPs remain adequate to show attainment and maintenance of the SO2 NAAQS. However, EPA disagrees with the Commenter that EPA must disapprove the Louisiana i-SIP for its alleged failure to include source-specific SO2 emission limits that show no exceedances of the NAAQS when modeled.

    As discussed above and in the 2013 Infrastructure SIP Guidance, the conceptual purpose of an i-SIP submission is to assure that the air agency's SIP contains the necessary structural requirements for the new or revised NAAQS and that the i-SIP submission process provides an opportunity to review the basic structural requirements of the Agency's air quality management program in light of the new or revised NAAQS. See, Infrastructure SIP Guidance at p. 2. The attainment planning process detailed in part D of the CAA, including sections 172 and 191-192, is the appropriate place for the state to evaluate measures needed to bring SO2 nonattainment areas into attainment with the 2010 SO2 NAAQS and to impose additional emission limitations such as SO2 emission limits on specific sources.

    EPA had initially recommended that states submit substantive attainment demonstration SIPs based on air quality modeling in the final 2010 SO2 NAAQS preamble (75 FR 35520) and in subsequent draft guidance issued in September 2011 for the section 110(a) SIPs due in June 2013 in order to show how areas expected to be designated as unclassifiable would attain and maintain the NAAQS. These initial statements in the preamble and 2011 draft guidance were based on EPA's expectation at the time; that by June 2012, most areas would initially be designated as unclassifiable due to limitations in the scope of the ambient monitoring network and the short time available before which states could conduct modeling to support designations recommendations in 2011. However, after conducting extensive stakeholder outreach and receiving comments from the states regarding these initial statements and the timeline for implementing the NAAQS, EPA subsequently stated in the April 12, 2012 letters and in the 2012 Draft White Paper that EPA was clarifying its implementation position and was no longer requiring such attainment demonstrations supported by air dispersion modeling for unclassifiable areas (which had not yet been designated) to be included in the June 2013 i-SIPs. EPA then reaffirmed this position in the February 6, 2013 memorandum, “Next Steps for Area Designations and Implementation of the Sulfur Dioxide National Ambient Air Quality Standard.” As previously mentioned, EPA had stated in the preamble to the NAAQS and in the prior 2011 draft guidance that EPA intended to develop and seek public comment on guidance for modeling and development of SO2 SIPs for sections 110, 172 and 191-192 of the CAA. After receiving such further comment, EPA has now issued guidance for the SO2 nonattainment area SIPs due pursuant to sections 172 and 191-192 and proposed a process for further characterization of areas with larger SO2 sources, which could include use of air dispersion modeling. See, April 23, 2014 Guidance for 1-Hour SO 2 Nonattainment Area SIP Submissions and 79 FR 27446 (proposing process and timetables for gathering additional information on impacts from larger SO2 sources informed through ambient monitoring and/or air quality modeling). EPA issued non-binding guidance for states to use in conducting, if they choose, additional analysis to support designations for the 2010 1-hour SO2 NAAQS. SO 2 NAAQS Designations Modeling Technical Assistance Document, EPA Office of Air and Radiation and Office of Air Quality Planning and Standards, February 2016, available at https://www.epa.gov/so2-pollution/technical-assistance-documents-implementing-2010-sulfur-dioxide-standard.

    While EPA guidance for SO2 attainment SIPs and the proposed process for further characterizing SO2 emissions from larger sources both discuss the use of air dispersion modeling, EPA's 2013 Infrastructure SIP Guidance did not suggest that states use air dispersion modeling to inform emission limitations for section 110(a)(2)(A) to ensure no exceedances of the NAAQS when sources are modeled, nor does the CAA or Code of Federal Regulations require that they do. Therefore, as discussed previously, the Louisiana i-SIP submittal contains the structural requirements to address elements in section 110(a)(2) as discussed in detail in the TSD accompanying the proposed approval. I-SIPs are general planning SIPs that ensure that a state has adequate resources and authority to implement a new or revised NAAQS. I-SIP submissions are not intended to act or fulfill the obligations of a detailed attainment and/or maintenance plan for each individual area of the state that is not attaining the NAAQS. While i-SIPs must address modeling authorities in general for section 110(a)(2)(K), this section requires i-SIPs to provide the state's authority for air quality modeling and for submission of modeling data to EPA, not specific air dispersion modeling. In the TSD for this rulemaking action, EPA provided a detailed explanation of Louisiana's ability and authority to conduct air quality modeling when required and its authority to submit modeling data to EPA.

    EPA finds Sierra Club's discussion of case law, guidance, and EPA staff statements regarding advantages of AERMOD as an air dispersion model to be irrelevant to the analysis of Louisiana's i-SIP as this is not an attainment SIP required to demonstrate attainment of the 2010 SO2 NAAQS pursuant to sections 172 or 192. In addition, Sierra Club's comments relating to EPA's use of AERMOD or modeling in general in SO2 designations pursuant to section 107 are likewise irrelevant as EPA's present approval of Louisiana's i-SIP is unrelated to the section 107 designations process nor is EPA's action on this i-SIP related to any nonattainment new source review (NNSR) or PSD permit program issue. As outlined in the August 23, 2010 clarification memo, “Applicability of Appendix W Modeling Guidance for the 1-hour SO2 National Ambient Air Quality Standard” (U.S. EPA, 2010a), AERMOD is the preferred model for single source modeling to address the 2010 1-hour SO2 NAAQS as part of the NNSR/PSD permit programs. Therefore, as attainment SIPs, designations, and NNSR/PSD actions are outside the scope of a required i-SIP submission for SO2 NAAQS for section 110(a), EPA provides no further response to the Commenter's discussion of air dispersion modeling for these applications. If Sierra Club resubmits its SO2 air dispersion modeling for the Louisiana's EGUs, or updated modeling information in the appropriate context, e.g., for designations, attainment SIPs, major source permitting, EPA will address the resubmitted modeling or updated modeling in the appropriate future context.

    The Commenter correctly noted that the Third Circuit upheld EPA's Section 126 Order imposing SO2 emissions limitations on an EGU pursuant to CAA section 126. GenOn REMA, LLC v. EPA, 722 F.3d 513. Pursuant to CAA section 126, any state or political subdivision may petition EPA for a finding that any major source or group of stationary sources emits, or would emit, any air pollutant in violation of the prohibition of section 110(a)(2)(D)(i)(I) which relates to significant contributions to nonattainment or maintenance in another state. The Third Circuit upheld EPA's authority under CAA section 126 and found EPA's actions neither arbitrary nor capricious after reviewing EPA's supporting docket which included air dispersion modeling as well as ambient air monitoring data showing violations of the NAAQS. The Sierra Club appears to have cited to this matter to demonstrate EPA's use of modeling for certain aspects of the CAA. EPA agrees with the Commenter regarding the appropriate role air dispersion modeling has for SO2 NAAQS designations, attainment SIPs, and demonstrating significant contributions to interstate transport. However, EPA's approval of Louisiana's i-SIP submission is based on our determination that Louisiana has the required structural requirements pursuant to CAA section 110(a)(2) in accordance with our explanation of the intent for i-SIP submissions as discussed in the 2013 Infrastructure SIP Guidance. Therefore, while air dispersion modeling may be appropriate for consideration in certain circumstances, EPA does not find air dispersion modeling of the NAAQS to be a required element before approval of i-SIP submission for CAA section 110(a) or specifically for 110(a)(2)(A) of the Act. Thus, EPA disagrees with the Commenter that EPA must require additional emission limitations in this Louisiana or other i-SIPs informed by air dispersion modeling and demonstrating attainment and maintenance of the NAAQS.

    In its comments, Sierra Club relies on Motor Vehicle Mfrs. Ass'n and NRDC v. EPA to support its comments that EPA must consider the Sierra Club's modeling data on the Dolet Hills Power Station and Big Cajun II Generating Station based on administrative law principles regarding consideration of comments provided during a rulemaking process. EPA asserts that it has considered the modeling as well as all the submitted comments of Sierra Club. However, as discussed in detail in the responses above, the i-SIPs required by CAA section 110(a) are not the appropriate place to require emission limits demonstrating future attainment with a NAAQS, and as such EPA is not explicitly considering the modeling results provided by the Sierra Club insofar as they support the contention that enforceable emissions limitations are a required part of an i-SIP submission.

    While i-SIP submissions are not required to contain emission limits, as suggested by the Commenter, EPA does recognize that in the past, states have used i-SIP submittals as a `vehicle' for incorporating regulatory revisions or source-specific emission limits into the state's plan. See, 78 FR 73442 (December 6, 2013) (approving regulations Maryland submitted for incorporation into the SIP along with the 2008 Ozone i-SIP to address ethics requirements for State Boards in sections 128 and 110(a)(2)(E)(ii)). While these SIP revisions are intended to help the state meet the requirements of section 110(a)(2), these “ride-along” SIP revisions are not intended to signify that all i-SIP submittals should have similar regulatory revisions or source-specific emission limits. Rather, the regulatory provisions and source-specific emission limits the state relies on when showing compliance with CAA section 110(a)(2) have likely already been incorporated into the state's SIP prior to each new i-SIP submission; in some cases this was done for entirely separate CAA requirements, such as attainment plans required under section 172, or for previous NAAQS.

    Comment 8: Sierra Club asserts that EPA may not approve the Louisiana proposed i-SIP submission because it fails to include enforceable emission limitations with a 1-hour averaging time that applies at all times. The Sierra Club cite to CAA section 302(k) which requires emission limits to apply on a continuous basis. The Commenter claims EPA has stated that 1-hour averaging times are necessary for the 2010 SO2 NAAQS citing to a February 3, 2011, EPA Region 7 letter to the Kansas Department of Health and Environment regarding the need for 1-hour SO2 emission limits in a PSD permit, an EPA Environmental Hearing Board (EHB) decision rejecting use of a 3-hour averaging time for a SO2 limit in a PSD permit, and EPA's disapproval of a Missouri SIP which relied on annual averaging for SO2 emission rates.7

    7 Sierra Club cited to In re: Mississippi Lime Co., PSDAPLPEAL 11-01, 2011 WL 3557194, at *26-27 (EPA Aug. 9, 2011) and 71 FR 12623, 12624 (March 13, 2006) (EPA disapproval of a control strategy SO2 SIP).

    Sierra Club also contends that i-SIPs approved by EPA must include monitoring of SO2 emission limits on a continuous basis using a continuous emission monitor system or systems (CEMS) and cites to section 110(a)(2)(F) which requires a SIP to establish a system to monitor emissions from stationary sources and to require submission of periodic emission reports. Sierra Club contends i-SIPs must require such SO2 CEMS to monitor SO2 sources regardless of whether sources have control technology installed to ensure limits are protective of the NAAQS. Thus, Sierra Club contends EPA must require enforceable emission limits, applicable at all times, with 1-hour averaging periods, monitored continuously with CEMS of large sources of SO2 emissions, and therefore must disapprove Louisiana's i-SIP which Sierra Club claims fails to require emission limits with adequate averaging times.

    Response 8: St. Bernard Parish was designated nonattainment effective October 4, 2013. LDEQ is required to bring St. Bernard Parish into compliance with the 1-hour standard as expeditiously as practicable, but no later than October 4, 2018. When the attainment demonstration SIP is submitted by the State, we will take action on it in a separate rulemaking action. The appropriate time for examining necessity of 1-hour SO2 emission limits on specific sources is within the attainment planning SIP rulemaking process. As such, EPA disagrees that we must disapprove the proposed Louisiana i-SIP because the submittal does not contain enforceable SO2 emission limitations with 1-hour averaging periods that apply at all times, along with requiring CEMS, as the State has addressed its SO2 nonattainment designation in another more appropriate document pursuant to section 107 of the CAA.8 As explained in detail in previous responses, the purpose of the i-SIP is to ensure that a state has the structural capability to attain and maintain the NAAQS and thus, additional SO2 emission limitations demonstrating future attainment and maintenance of the 2010 NAAQS are not required for such i-SIPs.9 Likewise, EPA need not address, for the purpose of approving Louisiana's i-SIP, whether CEMS or some other appropriate monitoring of SO2 emissions is necessary to demonstrate compliance with emission limits in order to show future attainment of the 2010 SO2 NAAQS as such SO2 emission limits and an attainment demonstration are not a prerequisite to EPA's approval of this or most other i-SIP submissions.10 Therefore, because EPA finds Louisiana's i-SIP submission approvable without the additional SO2 emission limitations showing future attainment of the NAAQS, EPA finds the issues of appropriate averaging periods and monitoring requirements for such future limitations not relevant at this time.

    8See, http://www.deq.louisiana.gov/portal/Portals/0/AirQualityAssessment/Planning/SIP/SO2%20SIP%20with%20Appendices%20-%20Final.pdf.

    9 For a discussion on emission averaging times for emissions limitations for SO2 attainment SIPs, see the April 23, 2014 Guidance for 1-Hour SO 2 Nonattainment Area SIP Submissions. EPA explained that it is possible, in specific cases, for states to develop control strategies that account for variability in 1-hour emissions rates through emission limits with averaging times that are longer than 1-hour, using averaging times as long as 30-days, but still provide for attainment of the 2010 SO2 NAAQS as long as the limits are of at least comparable stringency to a 1-hour limit at the critical emission value. EPA has not yet evaluated any specific submission of such a limit, and so is not at this time prepared to take final action to implement this concept. If and when a state submits an attainment demonstration that relies upon a limit with such a longer averaging time, EPA will evaluate it then.

    10 The appropriate time for application of monitoring requirements to demonstrate continuous compliance by specific sources is when such 1-hour emission limits are set for specific sources whether in permits issued by Louisiana pursuant to the SIP or in attainment SIPs submitted in the part D planning process.

    Sierra Club has cited to prior EPA discussion on emission limitations required in PSD permits (from an EAB decision and EPA's letter to Kansas' permitting authority) pursuant to part C of the CAA, which is neither relevant nor applicable to section 110 i-SIPs. In addition, as previously discussed, EPA disapproval of the 2006 Missouri SIP was a disapproval relating to a control strategy SIP required pursuant to part D attainment planning and is likewise not relevant to the analysis of i-SIP requirements.

    EPA has explained in the TSD supporting this rulemaking action how the Louisiana SIP meets requirements in section 110(a)(2)(F) related to monitoring. Thus, EPA finds Louisiana has the authority and responsibility to monitor air quality for the relevant NAAQS pollutants at appropriate locations and to submit data to EPA in a timely manner in accordance with 110(a)(2)(F) and the Infrastructure SIP Guidance.11 See, Infrastructure SIP Guidance at p. 45-46.

    11 While monitoring pursuant to NSPS requirements in 40 CFR part 60 may not be sufficient for 1-hour SO2 emission limits, Sierra Club's comment regarding NSPS monitoring provisions is not relevant at this time because EPA finds 1-hour SO2 emission limits and associated monitoring and averaging periods are not required for our approval of Louisiana's i-SIP.

    Comment 9: The Commenter alleges the Louisiana SIP contains exemption provisions for periods of startup and “operating adjustments” as well as variance provisions for “exceptional circumstances” which would cause undue hardship. See LAC 33:III.1507, 917, and 1505 (2012), respectively. The Commenter notes that NAAQS must be enforced at all times and sources cannot be granted variances under any circumstances, even startup, shutdown and malfunction, and cites EPA's recent SIP Call to 39 states. See State Implementation Plans: Response to Petition for Rulemaking; Findings of Substantial Inadequacy; and SIP Calls to Amend Provisions Applying to Excess Emissions During Periods of Startup, Shutdown, and Malfunctions; Final Rule, 80 FR 33840 (June 12, 2015). The Commenter claims that LDEQ must remove such provisions from the existing Louisiana SIP rules in order to properly comply with the infrastructure requirements for the 2010 SO2 NAAQS.

    Response 9: EPA disagrees with the Commenter that EPA is required to address all potential deficiencies that may exist in the Louisiana SIP in the context of evaluating an infrastructure SIP submission. In particular, an action on a state's infrastructure SIP submission is not necessarily the appropriate type of action in which to address possible deficiencies in a state's existing SIP rules related to excess emissions from sources during periods of startup, shutdown, or malfunction. It is not reasonable to read the general requirements of CAA section 110(a)(1) and the listing of elements in CAA section 110(a)(2) as requiring review of each and every provision of a state's existing SIP against all requirements in the CAA and the EPA regulations merely for purposes of assuring that the state in question has the basic structural elements for a functioning SIP for a new or revised NAAQS. In addition, EPA notes that the CAA provides other avenues and mechanisms to address specific substantive deficiencies in existing SIPs. For example, CAA section 110(k)(5) authorizes EPA to issue a SIP call whenever EPA determines a state's SIP is substantially inadequate to attain or maintain the NAAQS, to mitigate interstate transport, or to otherwise comply with the CAA. As noted by the Commenter, EPA has recently issued a SIP call to Louisiana requiring the removal of the exemption provision in LAC 33:III.1507. EPA is working closely with LDEQ to addressing the substantial inadequacies EPA identified in specific Louisiana SIP rules. See 80 FR 33967 (June 12, 2015). LDEQ is required to submit a revised SIP addressing the substantial inadequacies by November 22, 2016. EPA emphasizes that by approving Louisiana's i-SIP submission, EPA is not approving or reapproving any potentially deficient provisions that exist in the current SIP that relate to excess emissions. Furthermore, EPA's determination that an action on a state's infrastructure SIP submission is not the appropriate time and place to address all potential existing SIP deficiencies does not preclude EPA's subsequent reliance on provisions in CAA section 110(a)(2) as part of the basis for action to correct those deficiencies at a later time.

    Comment 10: The Sierra Club claims EPA must disapprove the proposed i-SIP for the 2008 ozone NAAQS for its failure to include enforceable measures on sources of volatile organic compounds (VOCs) and nitrogen oxides (NOX) to ensure attainment and maintenance of the NAAQS in areas not designated nonattainment and to ensure compliance with section 110(a)(2)(A) for the 2008 and future ozone NAAQS. The commenter specifically mentions EGUs as well as the oil and gas production industry as sources needing additional controls as they are major sources of ozone precursors. The Sierra Club claims stringent emission limits must apply at all times to ensure all areas in Louisiana attain and maintain the ozone NAAQS. The Commenter claims the ozone precursors can be reduced cost-effectively through installation of selective catalytic reductions (“SCR”) technology at EGUs. The commenter claims that Louisiana's EGUs do not use SCRs adequately to prevent ozone exceedances.

    In addition, the Commenter asserts that the Louisiana i-SIP must contain emission limits that include mass limitations and short term averaging periods on certain large sources of NOX such as power plants. These emission limits must apply at all times, to ensure that all areas of Louisiana attain and maintain the 2008 t8-hour ozone NAAQS. The Commenter also contends that adding control devices and emission limits on EGUs are a “cost effective option to reduce NOX pollution and attain and maintain the 2008 ozone NAAQS.”

    Finally, the Commenter states“[d]espite knowing that Louisiana is on the precipice of exceeding the ozone NAAQS, LDEQ is taking insufficient action to limit ozone concentrations and fails to demonstrate how it plans to address these significant ozone and ozone precursors. Consequently, EPA must disapprove the state's i-SIP.”

    Response 10: EPA has addressed in detail in prior responses above the Commenter's general arguments that the statutory language, legislative history, case law, EPA regulations, and prior rulemaking actions by EPA mandate the interpretation it advocates—i.e., that i-SIPs must ensure attainment and maintenance of the NAAQS. EPA's position is that the i-SIP submissions required by CAA section 110(a) are not the appropriate place to require emission limits demonstrating future attainment with a NAAQS as is explained more thoroughly in an above response. Moreover, the CAA recognizes and has provisions to address changes in air quality over time. These include provisions providing for redesignation in CAA section 107(d) and provisions in CAA section 110(k)(5) allowing EPA to call on the state to revise its SIP, as appropriate. Finally, EPA appreciates the Commenter's information regarding EGU NOX control measures and reduction efficiencies as well as emissions limitations applicable to new or modified EGUs which were set during the PSD or NSR permit process. Additional NOX regulations on emissions from the EGUs would likely reduce ozone levels further in one or more areas in Louisiana. Congress established the CAA such that each state has primary responsibility for assuring air quality within the state and each state is first given the opportunity to determine an emission reduction program for its areas subject to EPA approval, with such approval dependent upon whether the SIP as a whole meets the applicable requirements of the CAA. See Virginia v. EPA, 108 F.3d at 1410. The State could choose to consider additional control measures for NOX at EGUs to ensure attainment and maintenance of the ozone NAAQS as Louisiana moves forward to meet the more prescriptive planning requirements of the CAA in the future. However, as we have explained, the State is not required to regulate such sources for the purposes of meeting the i-SIP requirements of CAA section 110(a)(2).

    In addition, emission limits with the shorter-term averaging rates suggested by the Commenter could be considered within the CAA Title I part D planning process to ensure attainment and maintenance of the 2008 NAAQS. As EPA finds Louisiana's NOX and VOC provisions presently in the SIP sufficient for infrastructure SIP purposes and specifically for CAA section 110(a)(2)(A), further consideration of the averaging times is not appropriate or relevant at this time. Thus, EPA disagrees with the Commenter that Louisiana's i-SIP must be disapproved for failure to contain sufficient measures to ensure attainment and maintenance of the 2008 ozone NAAQS.

    Comment 11: The Sierra Club alleges that the proposed i-SIP does not address sources significantly contributing to nonattainment or interfering with maintenance of the NAAQS in other states as required by section 110(a)(2)(D)(i)(I) of the CAA, and states EPA must therefore disapprove the i-SIP. Sierra Club claims its modeling shows that emissions from Dolet Hills and Big Cajun II are contributing to exceedances in other states. Sierra Club states that the CAA requires i-SIPs to address cross-state air pollution. The Commenter argues that Louisiana has not done so and that EPA must disapprove the proposed infrastructure. The Commenter references the recent Supreme Court decision, EPA v. EME Homer City Generation, L.P. et al, 134 S. Ct. 1584 (2014), which supports the states' mandatory duty to address cross-state pollution under section 110(a)(2)(D)(i)(I).

    Response 11: The Sierra Club commented that Louisiana's i-SIP fails to address any cross-state impacts that are due to sources within the State. However in the proposed rulemaking for this final rule, EPA did address and propose to approve the good neighbor provisions in section 110(a)(2)(D)(i)(I) for the 2008 Pb and 2010 NO2 NAAQS,12 and we are finalizing those provisions in this rulemaking. The portion of the State's SIP addressing the good neighbor provision for the 2006 PM2.5 was approved on April 15, 2014 (79 FR 21142) and the 2008 ozone was disapproved August 12, 2016 (81 FR 53308). EPA will be addressing 110(a)(2)(D)(i)(I) for 2010 SO2 and the 2012 PM2.5 NAAQS in future actions. Thus, the comments relating to the substance and approvability of Louisiana's good neighbor provision in its 2010 SO2 and the 2012 PM2.5 NAAQS i-SIP submission are not relevant to this rulemaking action. As stated herein and in the NPR, EPA will take later, separate action on Louisiana's 2010 SO2 and the 2012 PM2.5 NAAQS i-SIP submissions to address section 110(a)(2)(D)(i)(I).

    12 81 FR 35674.

    The statutory language in the CAA supports our ability to approve Louisiana's NAAQS i-SIP submissions while taking later, separate action on the portion of the SIP submittals which address Louisiana's obligation to address section 110(a)(2)(D)(i)(I). Section 110(k)(3) of the CAA authorizes EPA to approve a plan in full, disapprove it in full, or approve it in part and disapprove it in part, depending on the extent to which such plan meets the requirements of the CAA. This authority to approve the states' SIP revisions in separable parts was included in the 1990 Amendments to the CAA to overrule a decision in the Court of Appeals for the Ninth Circuit holding that EPA could not approve individual measures in a plan submission without either approving or disapproving the plan as a whole. See, S. Rep. No. 101-228, at 22, 1990 U.S.C.C.A.N. 3385, 3408 (discussing the express overruling of Abramowitz v. EPA, 832 F.2d 1071 (9th Cir. 1987)).

    As such, EPA has the authority under section 110(k)(3), to use our discretion to approve or conditionally approve individual elements of Louisiana's infrastructure submission for NAAQS, separate and apart from any action with respect to the requirements of section 110(a)(2)(D)(i)(I). EPA views discrete i-SIP requirements, such as the requirements of 110(a)(2)(D)(i)(I), as severable from the other infrastructure elements and section 110(k)(3) allows us to act on individual severable measures in a plan submission. The commenter raises no compelling legal or environmental rationale for an alternate interpretation. Nothing in the Supreme Court's April 2014 decision in EME Homer City alters our interpretation that we may act on individual severable measures including the requirements of section 110(a)(2)(D)(i)(I) in a SIP submission. See, EPA v. EME Homer City Generation, L.P.,134 S. Ct. 1584 (2014) (affirming a state's obligation to submit a SIP revision addressing section 110(a)(2)(D)(i)(I) independent of EPA's action finding significant contribution or interference with maintenance).

    EPA's proposed approval of the Louisiana's i-SIP submission for NAAQS for the portions described in the NPR was therefore appropriate.

    III. Final Action

    EPA is approving i-SIP submissions from Louisiana submitted on May 16, 2011, October 10, 2011, June 4, 2013, and December 17, 2015, certifying that the State's current i-SIP is sufficient to meet the required infrastructure elements under sections 110(a)(1) and 110(a)(2) for the 2006 PM2.5, 2008 Pb, 2008 ozone, 2010 NO2, 2010 SO2 and 2012 PM2.5 with exception of certain aspects relating to CAA section 110(a)(2)(D)(i)(I) for the 2008 ozone, 2010 SO2 and 2012 PM2.5 and disapproval for the visibility protection portion of CAA section 110(a)(2)(D)(i)(II) for all pollutants except the 2008 Pb NAAQS. The elements in which no action is taken, or for which disapproval was given will be or have been addressed in other actions. Please see the Table 1 below.

    Table 1—Final Action on Louisiana Infrastructure SIP Submittal for Various NAAQS Element 2006 PM2.5 2008 Pb 2008 Ozone 2010 NO2 2010 SO2 2012 PM2.5 (A): Emission limits and other control measures A A A A A A (B): Ambient air quality monitoring and data system A A A A A A (C)(i): Enforcement of SIP measures A A A A A A (C)(ii): PSD program for major sources and major modifications A A A A A A (C)(iii): Permitting program for minor sources and minor modifications A A A A A A (D)(i)(I): Contribute to nonattainment/interfere with maintenance of NAAQS (requirements 1 and 2) A* A No action A No action No action (D)(i)(II): PSD (requirement 3) A A A A A A (D)(i)(II): Visibility Protection (requirement 4) D A D D D D (D)(ii): Interstate and International Pollution Abatement A A A A A A (E)(i): Adequate resources A A A A A A (E)(ii): State boards A A A A A A (E)(iii): Necessary assurances with respect to local agencies A A A A A A (F): Stationary source monitoring system A A A A A A (G): Emergency power A A A A A A (H): Future SIP revisions A A A A A A (I): Nonattainment area plan or plan revisions under part D + + + + + + (J)(i): Consultation with government officials A A A A A A (J)(ii): Public notification A A A A A A (J)(iii): PSD A A A A A A (J)(iv): Visibility protection + + + + + + (K): Air quality modeling and data A A A A A A (L): Permitting fees A A A A A A (M): Consultation and participation by affected local entities A A A A A A Key to Table 1: Proposed action on LA infrastructure SIP submittals for various NAAQS. A—Approve. A*—Approved at an earlier date. +—Not germane to infrastructure SIPs. No action—EPA is taking no action on this infrastructure requirements. D—Disapprove. IV. Statutory and Executive Order Reviews A. Executive Order 12866: Regulatory Planning and Review and Executive Order 13563: Improving Regulation and Regulatory Review

    This final action is not a “significant regulatory action” and was therefore not submitted to the Office of Management and Budget for review.

    B. Paperwork Reduction Act (PRA)

    This final action does not impose an information collection burden under the PRA because it does not contain any information collection activities.

    C. Regulatory Flexibility Act (RFA)

    I certify that this action will not have a significant economic impact on a substantial number of small entities under the RFA. This action merely approves or disapproves a SIP submission as not meeting the CAA.

    D. Unfunded Mandates Reform Act (UMRA)

    This action does not contain any unfunded mandate as described in UMRA, 2 U.S.C. 1531-1538, and does not significantly or uniquely affect small governments. The action imposes no enforceable duty on any state, local or tribal governments or the private sector.

    E. Executive Order 13132: Federalism

    This action does not have federalism implications. It will not have substantial direct effects on the states, on the relationship between the national government and the states, or on the distribution of power and responsibilities among the various levels of government.

    F. Executive Order 13175: Consultation and Coordination With Indian Tribal Governments

    This action does not have tribal implications as specified in Executive Order 13175. This action does not apply on any Indian reservation land, any other area where EPA or an Indian tribe has demonstrated that a tribe has jurisdiction, or non-reservation areas of Indian country. Thus, Executive Order 13175 does not apply to this action.

    G. Executive Order 13045: Protection of Children From Environmental Health Risks and Safety Risks

    EPA interprets Executive Order 13045 as applying only to those regulatory actions that concern environmental health or safety risks that EPA has reason to believe may disproportionately affect children, per the definition of “covered regulatory action” in section 2-202 of the Executive Order. This action is not subject to Executive Order 13045 because it merely approves or disapproves a SIP submission as not meeting the CAA.

    H. Executive Order 13211: Actions That Significantly Affect Energy Supply, Distribution or Use

    This action is not subject to Executive Order 13211, because it is not a significant regulatory action under Executive Order 12866.

    I. National Technology Transfer and Advancement Act

    This rulemaking does not involve technical standards.

    J. Executive Order 12898: Federal Actions To Address Environmental Justice in Minority Populations and Low-Income Populations

    EPA believes the human health or environmental risk addressed by this action will not have potential disproportionately high and adverse human health or environmental effects on minority, low-income or indigenous populations. This action merely approves or disapproves a SIP submission as not meeting the CAA requirements.

    The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the Small Business Regulatory Enforcement Fairness Act of 1996, generally provides that before a rule may take effect, the agency promulgating the rule must submit a rule report, which includes a copy of the rule, to each House of the Congress and to the Comptroller General of the United States. EPA will submit a report containing this action and other required information to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States prior to publication of the rule in the Federal Register. A major rule cannot take effect until 60 days after it is published in the Federal Register. This action is not a “major rule” as defined by 5 U.S.C. 804(2).

    Under section 307(b)(1) of the CAA, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by December 5, 2016. Filing a petition for reconsideration by the Administrator of this final rule does not affect the finality of this action for the purposes of judicial review nor does it extend the time within which a petition for judicial review may be filed, and shall not postpone the effectiveness of such rule or action. This action may not be challenged later in proceedings to enforce its requirements. (See section 307(b)(2).)

    List of Subjects in 40 CFR Part 52

    Environmental protection, Air pollution control, Incorporation by reference, Intergovernmental relations, Interstate transport of pollution, Lead, Nitrogen dioxide, Ozone, Particulate matter, Reporting and recordkeeping requirements, Sulfur oxides.

    Dated: September 29, 2016. Samuel Coleman, Acting Regional Administrator, Region 6.

    40 CFR part 52 is amended as follows:

    PART 52—APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS 1. The authority citation for part 52 continues to read as follows: Authority:

    42 U.S.C. 7401 et seq.

    Subpart T—Louisiana 2. Section 52.970(e) is amended by adding six entries at the end of the second table titled “EPA Approved Louisiana Provisions and Quasi-Regulatory Measures” to read as follows:
    § 52.970 Identification of plan.

    (e) * * *

    EPA Approved Louisiana Nonregulatory Provisions and Quasi-Regulatory Measures Name of SIP provision Applicable geographic or
  • nonattainment area
  • State
  • submittal/
  • effective date
  • EPA approval date Explanation
    *         *         *         *         *         *         * Infrastructure for the 2006 PM2.5 NAAQS Statewide 5/16/11 10/4/16 [Insert Federal Register citation] Approval for 110(a)(2)(A), (B), (C), (D)(i) (portion pertaining to PSD), D(ii), (E), (F), (G), (H), (J), (K), (L) and (M). Infrastructure for the 2008 Pb NAAQS Statewide 10/10/11 10/4/16 [Insert Federal Register citation] Approval for 110(a)(2)(A), (B), (C), (D), (E), (F), (G), (H), (J), (K), (L) and (M). Infrastructure for the 2008 O3 NAAQS Statewide 6/4/13 10/4/16 [Insert Federal Register citation] Approval for 110(a)(2)(A), (B), (C), (D)(i) (portion pertaining to PSD), D(ii), (E), (F), (G), (H), (J), (K), (L) and (M). Infrastructure for the 2010 NO2 NAAQS Statewide 6/4/13 10/4/16 [Insert Federal Register citation] Approval for 110(a)(2)(A), (B), (C), (D)(i) (portions pertaining to nonattainment, interference with maintenance and PSD), D(ii), (E), (F), (G), (H), (J), (K), (L) and (M). Infrastructure for the 2010 SO2 NAAQS Statewide 6/4/13 10/4/16 [Insert Federal Register citation] Approval for 110(a)(2)(A), (B), (C), (D)(i) (portion pertaining PSD), D(ii), (E), (F), (G), (H), (J), (K), (L) and (M). Infrastructure for the 2012 PM2.5 NAAQS Statewide 12/17/15 10/4/16 [Insert Federal Register citation] Approval for 110(a)(2)(A), (B), (C), (D)(i) (portion pertaining to PSD), D(ii), (E), (F), (G), (H), (J), (K), (L) and (M).
    3. Section 52.996 is amended by adding paragraph (b) to read as follows:
    § 52.996 Disapprovals.

    (b) The portions of the SIP submitted on May 16, 2011, June 4, 2013, and December 17, 2015 addressing noninterference with measures required to protect visibility in any other state (Clean Air Act section 110(a)(2)(D)(i)(II)) are disapproved for the following National Ambient Air Quality Standards: 2006 PM2.5, 2008 Ozone, 2010 NO2, 2010 SO2 and 2012 PM2.5.

    [FR Doc. 2016-24036 Filed 10-3-16; 8:45 am] BILLING CODE 6560-50-P
    GENERAL SERVICES ADMINISTRATION 48 CFR Parts 503 and 552 [GSAR Change 76; GSAR Case 2016-G501; Docket No. 2016-0018; Sequence No. 1] RIN 3090-AJ78 General Services Administration Acquisition Regulation (GSAR); Inflation of Acquisition-Related Thresholds AGENCY:

    Office of Acquisition Policy, General Services Administration (GSA).

    ACTION:

    Final rule.

    SUMMARY:

    The General Services Administration (GSA) is amending the General Services Administration Acquisition Regulation (GSAR) to make editorial changes. This case updates acquisition-related thresholds to align with the Federal Acquisition Regulation (FAR).

    DATES:

    Effective: October 4, 2016.

    FOR FURTHER INFORMATION CONTACT:

    For clarification of content, contact Ms. Janet Fry, Procurement Analyst, General Services Acquisition Policy Division, GSA, at 703-605-3167. For information pertaining to status or publication schedules, contact the Regulatory Secretariat at 202-501-4755. Please cite GSAR case 2016-G501.

    SUPPLEMENTARY INFORMATION: I. Discussion of Changes

    The General Services Administration (GSA) is amending the General Services Administration Acquisition Regulation (GSAR) to make editorial changes to align acquisition thresholds with the Federal Acquisition Regulation (FAR). There are no significant content changes resulting from this case.

    GSAR section 503.1004(a) is updated to remove the duplicative and unnecessary language regarding the outdated $5,000,000 FAR threshold for including FAR 52.203-14, Display of Hotline Poster(s). The remaining text regarding the $1,000,000 threshold for disaster assistance funds is retained with minor edits.

    Contract GSAR clauses 552.219-71, Notice to Offerors of Subcontracting Plan Requirements, and 552.219-72, Preparation, Submission and Negotiation of Subcontracting Plans, are updated to remove reference to the acquisition threshold of $650,000 and the language is restructured to no longer state the threshold but rather direct the reader to FAR 52.219-9 which clearly addresses the thresholds for subcontracting plans. By referencing back to the FAR, future inflation updates will not require amendments to the GSAR.

    GSAR clause 552.270-13, Proposals for Adjustment, is updated to replace “$500,000” with “$750,000.” Referencing the FAR for the threshold to prevent future updates was not an alternative.

    II. Public Comments Not Required

    41 U.S.C. 1707, Publication of proposed regulations, applies to the publication of the General Services Administration Acquisition Regulation. Paragraph (a)(1) of the statute requires that a procurement policy, regulation, procedure or form including amendment or modification thereof must be published for public comment if it has either a significant effect beyond the internal operating procedures of the agency issuing the policy, regulation, procedure, or form or has a significant cost or administrative impact on contractor or offerors. This final rule is not required to be published for public comment because it contains minor editorial updates without changing the meaning of content. The changes do not have a significant impact on the public.

    III. Executive Orders 12866 and 13563

    Executive Orders (E.O.s) 12866 and 13563 direct agencies to assess all costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, distributive impacts, and equity). E.O. 13563 emphasizes the importance of quantifying both costs and benefits, of reducing costs, of harmonizing rules, and of promoting flexibility. This is not a significant regulatory action and, therefore, was not subject to review under Section 6(b) of E.O. 12866, Regulatory Planning and Review, dated September 30, 1993. This rule is not a major rule under 5 U.S.C. 804.

    IV. Regulatory Flexibility Act

    The Regulatory Flexibility Analysis does not apply to this rule because this final rule does not constitute a significant GSAR revision and 41 U.S.C. 1707 does not require publication for public comment.

    V. Paperwork Reduction Act

    The final rule does not contain any information collection requirements that require approval of the Office of Management and Budget under the Paperwork Reduction Act (44 U.S.C. chapter 35).

    List of Subjects in 48 CFR Parts 503 and 552

    Government procurement.

    Dated: September 29, 2016. Jeffrey A. Koses, Senior Procurement Executive, Office of Acquisition Policy, Office of Government-wide Policy.

    Therefore, GSA is amending 48 CFR parts 503 and 552 as set forth below:

    1. The authority citation for 48 CFR parts 503 and 552 continues to read as follows: Authority:

    40 U.S.C. 121(c).

    PART 503—IMPROPER BUSINESS PRACTICES AND PERSONAL CONFLICTS OF INTEREST 2. Amend section 503.1004 by revising paragraph (a) to read as follows:
    503.1004 Contract clauses.

    (a) GSA has exercised the authority provided at FAR 3.1004(b)(1)(i) to establish a lower threshold for inclusion of clause 52.203-14, Display of Hotline Poster(s). When the contract or order is funded with disaster assistance funds, the threshold is $1,000,000.

    PART 552—SOLICITATION PROVISIONS AND CONTRACT CLAUSES 3. Amend section 552.219-71 by revising the date of the provision and the provision to read as follows:
    552.219-71 Notice to Offerrors of Subcontracting Plan Requirements. Notice to Offerrors of Subcontracting Plan Requirements (Oct 2016)

    The General Services Administration (GSA) is committed to assuring that maximum practicable opportunity is provided to small, HUBZone small, small disadvantaged, women-owned, veteran-owned, and service-disabled veteran-owned small business concerns to participate in the performance of this contract consistent with its efficient performance. GSA expects any subcontracting plan submitted pursuant to FAR 52.219-9, Small Business Subcontracting Plan, to reflect this commitment. The plan must demonstrate a creative and innovative program for involving small, HUBZone small, small disadvantaged, women-owned, veteran-owned, and service-disabled veteran-owned small business concerns as subcontractors in the performance of this contract.

    4. Amend section 552.219-72 by revising the date of the provision and paragraph (a) to read as follows:
    552.219-72 Preparation, Submission, and Negotiation of Subcontracting Plans. Preparation, Submission, and Negotiation of Subcontracting Plans (Oct 2016)

    (a) When submitting a subcontracting plan in accordance with FAR 52.219-9, the offeror shall submit a subcontracting plan with its initial offer. The subcontracting plan will be negotiated concurrently with price and any required technical and management proposals, unless the offeror submits a previously-approved commercial plan.

    5. Amend section 552.270-13 by revising the date of the provision; and removing from paragraph (c) introductory text and paragraph (c)(2) “500,000” and adding “750,000” in their places, respectively.

    The revision reads as follows.

    552.270-13 Proposals for Adjustment. Proposals for Adjustment (Oct 2016)
    [FR Doc. 2016-24015 Filed 10-3-16; 8:45 am] BILLING CODE 6820-61-P
    DEPARTMENT OF TRANSPORTATION Federal Motor Carrier Safety Administration 49 CFR Parts 355, 356, 365, 369, 370, 373, 374, 376, 377, 378, 382, 383, 384, 385, 386, 390, 391, 392, 395, 397, and 398 RIN 2126-AB95 General Technical, Organizational, Conforming, and Correcting Amendments to the Federal Motor Carrier Safety Regulations AGENCY:

    Federal Motor Carrier Safety Administration (FMCSA), DOT.

    ACTION:

    Final rule.

    SUMMARY:

    FMCSA amends its regulations by making technical corrections throughout. The Agency is making minor changes to correct errors and omissions, ensure conformity with Office of the Federal Register style guidelines, update cross references, and improve clarity and consistency of certain regulatory provisions. Further, this set of amendments removes all remaining instances of the term “common carrier” and “contract carrier” as required by the ICC Termination Act (ICCTA) and the Safe, Accountable, Flexible, Efficient Transportation Equity Act: A Legacy for Users (SAFETEA-LU). This rule does not make any substantive changes to the affected regulations, except to remove obsolete provisions.

    DATES:

    Effective Date: The final rule is effective September 30, 2016.

    FOR FURTHER INFORMATION CONTACT:

    Mr. David Miller, Federal Motor Carrier Safety Administration, Regulatory Development Division, 1200 New Jersey Avenue SE., Washington, DC 20590-0001, by telephone at (202) 366-5370 or via email at [email protected] Office hours are from 9:00 a.m. to 5:00 p.m. e.t., Monday through Friday, except Federal holidays.

    SUPPLEMENTARY INFORMATION:

    Legal Basis for the Rulemaking

    Congress delegated certain powers to regulate interstate commerce to the United States Department of Transportation (DOT or Department) in numerous pieces of legislation, most notably in section 6 of the Department of Transportation Act (DOT Act) (Pub. L. 85-670, 80 Stat. 931 (1966)). Section 55 of the DOT Act transferred to the Department the authority of the former Interstate Commerce Commission (ICC) to regulate the qualifications and maximum hours-of-service of employees, the safety of operations, and the equipment of motor carriers in interstate commerce. See 49 United States Code (U.S.C.) 104. This authority, first granted to the ICC in the Motor Carrier Act of 1935 (Pub. L. 74-255, 49 Stat. 543, Aug. 9, 1935), now appears in 49 U.S.C. chapter 315. The regulations issued under this authority became known as the Federal Motor Carrier Safety Regulations (FMCSRs), appearing generally at 49 CFR parts 350-399. The administrative powers to enforce chapter 315 were also transferred from the ICC to the DOT in 1966 and appear in 49 U.S.C. chapter 5. The Secretary of the DOT (Secretary) delegated oversight of these provisions to the Federal Highway Administration (FHWA), a predecessor agency of FMCSA. The FMCSA Administrator has been delegated authority under 49 CFR 1.87 to carry out the motor carrier functions vested in the Secretary.

    Between 1984 and 1999, a number of statutes added to FHWA's authority. Various statutes authorize the enforcement of the FMCSRs, the Hazardous Materials Regulations (HMRs), and the Commercial Regulations, and provide both civil and criminal penalties for violations of these requirements. These statutes include the Motor Carrier Safety Act of 1984 (Pub. L. 98-554, 98 Stat. 2832, Oct. 30, 1984), codified at 49 U.S.C. chapter 311, subchapter III (MCSA); the Commercial Motor Vehicle Safety Act of 1986 (Pub. L. 99-570, 100 Stat. 3207-170, Oct. 27, 1986), codified at 49 U.S.C. chapter 313; the Hazardous Materials Transportation Uniform Safety Act of 1990, as amended (Pub. L. 101-615, 104 Stat. 3244, Nov. 16, 1990), codified at 49 U.S.C. chapter 51; and the ICCTA of 1995 (Pub. L. 104-88, 109 Stat. 803, Dec. 29, 1995), codified at 49 U.S.C. chapters 131-149.

    The Motor Carrier Safety Improvement Act of 1999 (MCSIA) (Pub. L. 106-159, 113 Stat. 1748, Dec. 9, 1999) established FMCSA as a new operating administration within DOT, effective January 1, 2000. The motor carrier safety responsibilities previously assigned to both ICC and FHWA are now assigned to FMCSA.

    Congress expanded, modified, and amended FMCSA's authority in the Uniting and Strengthening America by Providing Appropriate Tools Required to Intercept and Obstruct Terrorism (USA PATRIOT) Act of 2001 (Pub. L. 107-56, 115 Stat. 272, Oct. 26, 2001), SAFETEA-LU (Pub. L. 109-59, 119 Stat. 1144, Aug. 10, 2005), the SAFETEA-LU Technical Corrections Act of 2008 (Pub. L. 110-244, 122 Stat. 1572, June 6, 2008), and the Moving Ahead for Progress in the 21st Century Act (MAP-21) (Pub. L. 112-141, 126 Stat. 405, July 6, 2012).

    The specific regulations amended by this rule are based on the statutes detailed above. Generally, the legal authority for each of those provisions was explained when the requirement was originally adopted and is noted at the beginning of each part in title 49 of the CFR. Title 49 CFR subtitle B, chapter III, contains all of the FMCSRs.

    The Administrative Procedure Act (APA) (5 U.S.C. 551-706) specifically provides exceptions to its notice and public comment rulemaking procedures where the Agency finds there is good cause (and incorporates the finding and a brief statement of reasons therefore in the rules issued) to dispense with them. Generally, good cause exists where the Agency determines that notice and public procedures are impractical, unnecessary, or contrary to the public interest (5 U.S.C. 553(b)(3)(B)). The amendments made in this final rule merely correct inadvertent errors and omissions, remove or update obsolete references, and make minor changes to improve clarity and consistency. The technical amendments do not impose any new requirements, nor do they make any substantive changes to the CFR. For these reasons, FMCSA finds good cause that notice and public comment on this final rule is unnecessary.

    The APA also allows agencies to make rules effective upon publication with good cause (5 U.S.C. 553(d)(3)), instead of requiring publication 30 days prior to the effective date. For the reasons already stated, FMCSA finds there is good cause for this rule to be effective on the date of publication in the Federal Register.

    FMCSA is aware of the regulatory reform requirements imposed by section 5202 of the Fixing America's Surface Transportation Act (FAST Act) (Pub. L. 114-94, 129 Stat. 1312, at 1534, Dec. 4, 2015) concerning public participation in FMCSA rulemaking (49 U.S.C. 31136(g)). These requirements pertain to certain major rules,1 but because this final rule is not major, they are not applicable. In any event, the Agency finds that, for the reasons stated below, publication of an advance notice of proposed rulemaking under 49 U.S.C. 31136(g)(1)(A), or a negotiated rulemaking under 49 U.S.C. 31136(g)(1)(B), is unnecessary and contrary to the public interest in accordance with the waiver provision in 49 U.S.C. 31136(g)(3).

    1 A “major rule” is defined by the Congressional Review Act, Pub. L. 104-121, title II, section 251, Mar. 29, 1996, 110 Stat. 873, and is codified at 5 U.S.C. 804(2). See https://www.thefederalregister.org/fdsys/pkg/USCODE-2014-title5/pdf/USCODE-2014-title5-partI-chap8-sec804.pdf.

    Background

    This document makes editorial changes to correct inaccurate references and citations, improve clarity, and fix errors. The reasons for each of these minor revisions are set out below, in a section-by-section description of the changes. These amendments do not impose any new requirements.

    This set of amendments removes all remaining instances of the term “common” and “contract” as required by the ICCTA and SAFETEA-LU. Many instances of these terms were removed in the FMCSA Unified Registration System (URS) final rules published in 2013, 2015, and 2016,2 and this rule removes the remaining instances found in 49 CFR chapter III, subchapter B. This rule does not make any substantive changes to the affected regulations, except to remove eight obsolete provisions. Four of the provisions relate to the use of the terms “common” and “contract” and certain property-carrier routing requirements eliminated by the ICCTA. The other four obsolete provisions relate to a Congressionally-sunset emergency commercial driver's license grant, a pre-2014 medical exam schedule, outdated medical forms, and an obsolete reporting requirement.

    2Final Rule, Unified Registration System, 78 FR 52608 (Aug. 23, 2013), amendments, corrections, and delayed effective and compliance dates published at 80 FR 63703, October 21, 2015, and 81 FR 49553, July 28, 2016.

    FMCSA is adding “for-hire, non-exempt” to many rules to ensure motor carriers know the rules are only applicable to for-hire, non-exempt motor carriers, similar to the amendments being made in the URS final rules.

    Use of the term “non-exempt” in these sections and other technical amendments related to the use of the terms “common” and “contract” below is to ensure motor carriers exempted by Congress from jurisdiction under 49 U.S.C. subtitle IV, part B, and specifically sec. 13506, do not feel compelled to comply with the amended rule text. FMCSA has discovered over the years that many for-hire, exempt 3 motor carriers and their drivers (such as livestock, grain, and produce haulers), mistakenly believe that 49 U.S.C. subtitle IV, part B (secs. 13101 through 14916), are mandatory requirements applicable to their operations.

    3 An exempt for-hire motor carrier transports exempt (unregulated) property owned by others for compensation. The exempt commodities usually include unprocessed or unmanufactured goods, fruits, and vegetables, and other items of little or no value. For a partial listing of exempt and non-exempt commodities, please refer to Administrative Ruling No 119 at https://www.fmcsa.dot.gov/sites/fmcsa.dot.gov/files/docs/Administrative_Ruling_119.pdf. An exempt for-hire motor carrier is subject to the safety regulations in 49 CFR chapter III, subchapter B.

    For-hire motor carriers transporting commodities, or agreeing to transport brokered loads of commodities, that are listed by statutes, FMCSA regulations, and FMCSA administrative rulings, as exempt from 49 U.S.C. subtitle IV, part B, are not subject to non-safety related rules administered by FMCSA. Such for-hire, exempt motor carriers thus are not required to comply with the following rules that are authorized under 49 U.S.C. subtitle IV, part B:

    • Annual economic reporting requirements in part 369;

    • Receipts and bills of lading in part 373;

    • Loss and damage claim requirements in part 370;

    • Property broker requirements in part 371;

    • Passenger carrier regulations in part 374;

    • Household goods transportation regulations in part 375;

    • Lease and interchange of vehicle rules in part 376;

    • Payment of transportation charge rules in part 377;

    • Overcharge, duplicate payment, and overcollection claims in part 378; and

    • Preservation of records in part 379.

    Motor carriers and shippers should be aware of the italicized text below related to contract carriage operations, “. . . A carrier providing transportation or service subject to jurisdiction under chapter 135 may enter into a contract with a shipper, . . . to provide specified services under specified rates and conditions. If the shipper and carrier, in writing, expressly waive any or all rights and remedies under this part for the transportation covered by the contract, the transportation provided under the contract shall not be subject to the waived rights and remedies and may not be subsequently challenged on the ground that it violates the waived rights and remedies . . .” 4 [emphasis added]

    4 49 U.S.C. 14101(b)(1).

    The statutory reference to the waiver of “any or all rights and remedies” allows a shipper and a motor carrier to negotiate and enter into a private contract that establishes selected rights and remedies different from the general “motor carrier” rights and remedies otherwise provided under 49 U.S.C. 14101, 14706, and other statutes. The waiver provision gives the carrier and shipper the flexibility to select the rights and remedies they wish to establish by contract. They can choose to leave in place other rights and remedies to be governed by statutes and regulations applicable to “motor carriers.”“. . . New 49 U.S.C. 14101 (Providing transportation and service), taken from existing 49 U.S.C. 11101, would continue the basic common carrier obligation to provide transportation or service on reasonable request and to provide safe and adequate service, equipment, and facilities. It would expressly allow carriers to enter contracts for specific shipments (other than for residential household goods movements arranged and paid for directly by the householder) under which both parties may waive their ICA rights and remedies.” 5

    5 Sen. Report 104-176 (1995) at 46, https://www.thefederalregister.org/fdsys/pkg/CRPT-104srpt176/pdf/CRPT-104srpt176.pdf.

    See also M. Fortunoff of Westbury Corp. v. Peerless Ins. Co., 432 F.3d 127 (2nd Cir. 2005) at 132-133 (emphasis in original):

    Congress enacted the [ICC Termination Act] in 1995 and merged the separate classifications of common and contract carrier into one classification termed “motor carrier,” governing any “person providing motor vehicle transportation for compensation.” 49 U.S.C. 13102(12). The ICCTA provided that all motor carriers were to register under sec. 13902(a) as opposed to the old regime of separately registered common and contract carriers. Under [49 U.S.C.] 14101, registered motor carriers must provide common carriage services and may provide contract carriage services.

    With respect to all revisions to the terms “common” and “contract,” FMCSA has attempted to simply set out the governing regulatory provisions for “motor carriers” (or for “for-hire motor carriers,” which captures the “for compensation” language in the statutory definition of “motor carrier” in 49 U.S.C. 13102(14)). This leaves a motor carrier and shipper the flexibility contemplated by the statute to choose “any or all” rights and remedies to be waived, while those not waived remain in full effect.

    It should be noted that for-hire, exempt motor carriers transporting exempted (unregulated) commodities may not submit a claim to the FMCSA-mandated $75,000 financial responsibility instrument held by an authorized property broker, their sureties, or their trust fund managers for payments owed to the exempted motor carrier, based on the authorized property broker's failure to carry out its contracts, agreements, or arrangements for the supplying of exempt (unregulated) commodity transportation by exempt motor carriers. An exempt motor carrier is not authorized by FMCSA to operate under 49 U.S.C. subtitle IV, part B, and thus does not have legitimate access to the FMCSA-authorized property broker's $75,000 financial responsibility instrument. The $75,000 financial instrument is only applicable when the FMCSA-authorized property broker fails to carry out its contracts, agreements, or arrangements for the supplying of authorized (regulated) commodity transportation by FMCSA-authorized motor carriers.

    Section-by-Section Analysis

    This section-by-section analysis describes the technical amendment provisions and corrections in numerical order.

    Appendix A of Part 355—Guidelines for the Regulatory Review of Compatible State Laws and Regulations Affecting Interstate Motor Carrier Operations

    FMCSA replaces a phrase that includes the terms common and contract with a phrase that no longer uses those two terms. Currently, the applicability section references the appendix's requirements that each State shall review its laws and regulations to achieve compatibility with the FMCSRs. Each State's “. . . requirements must apply to all segments of the motor carrier industry common, contract, and private carriers of property and for-hire carriers of passengers.” FMCSA replaces the phrase “motor carrier industry common, contract,” with the phrase “motor carrier industry, for-hire.”

    For-Hire Motor Carrier of Property Routing Requirements in §§ 356.7—356.13

    Four sections are being removed from part 356 as a result of FMCSA's review of “common” and “contract” amendments. The ICCTA eliminated the need for for-hire motor carriers of property to apply to a Federal agency and be granted authority to drive on particular, specified, and declared highway routes. In considering how to change the term “common” to something else in §§ 356.7 to 356.13, FMCSA determined that each of these four sections is no longer applicable to anyone as each section only applied to property carriers that no longer need route authority. Therefore, FMCSA removes all four rule sections with the headings “Tacking,”Elimination of routing restrictions—regular route carriers,”Elimination of gateways—regular and irregular route carriers,” and “Redesignated highways.”

    § 365.105 Starting the Application Process: Form OP-1

    FMCSA is updating the universal resource locators (URL) for Form OP-1 to accurately reflect where to obtain the forms. Since December 2015, new applicants must apply for a USDOT number and, if applicable, operating authority, by electronically filing Form MCSA-1, the URS online application. Registrants, who had operating authority before December 2015, may still use Form OP-1 to update their registration information, but the Agency did not update the URLs where the forms may be obtained.

    § 365.205 Contents of the Protest

    FMCSA updates this section to replace an outdated phone number and add an additional way to contact FMCSA for help. FMCSA no longer uses the 202 area code phone number listed in this section. FMCSA has replaced the 202 number with a toll-free telephone number and has added an online web form in which the public may contact FMCSA for further assistance in developing their evidence for filing a protest.

    § 365.413 Procedures for Changing the Name or Business Form of a Motor Carrier, Freight Forwarder, or Property Broker

    FMCSA amends this section to add two additional ways for current registrants to contact FMCSA to change the name or business form of a registered motor carrier, freight forwarder, or property broker. For such registrants to make such changes, FMCSA has developed a two-page form MCSA-5889, “Motor Carrier Records Change Form,” Office of Management and Budget (OMB) No. 2126-0060, approved by OMB for use through July 31, 2018. FMCSA continues to allow the letter to be mailed, with the five required pieces of information in redesignated § 365.413(c)(1) through (5). But FMCSA now adds to the list of options the opportunity for form MCSA-5889 to be faxed to FMCSA at the number given, or scanned and submitted via the web form at https://www.fmcsa.dot.gov/ask.

    Part 369—Reports of Motor Carriers

    FMCSA makes several amendments related to the terms “common” and “contract” to part 369 applicable to annual reports of for-hire motor carriers. FMCSA modifies each paragraph (a) in §§ 369.1, 369.2, and 369.3 to replace the phrase “common and contract” with the phrase “for-hire, non-exempt motor” to comport with the elimination of the terms “common” and “contract” in the ICCTA.

    § 370.9 Disposition of Claims

    The Agency makes one amendment related to the term “common” to Part 370 applicable to disposition of claims. Paragraph (b) is amended to replace “common carrier by motor vehicle of household goods as defined in § 375.103 of this chapter” with “household goods motor carrier as defined in § 375.103 of this subchapter” for use when settling a claim for loss or damage to household goods or an individual shipper's property. This paragraph will continue to use the current defined term “household goods motor carrier” in § 375.103 that comes from the Household Goods Mover Oversight Enforcement and Reform Act of 2005 (August 10, 2005), and any person considered to be a household goods motor carrier under regulations, determinations, and decisions of the FMCSA on August 10, 2005.

    New § 373.100 and § 374.1 Applicability

    FMCSA adds two new applicability sections to ensure the public understands that parts 373 and 374 are limited to for-hire motor carriers subject to jurisdiction under 49 U.S.C. subtitle IV, part B.

    § 373.101 Motor Carrier Bills of Lading

    The Agency makes two amendments related to the term “common” applicable to motor carrier bills of lading. FMCSA revises the heading to add “for-hire, non-exempt” and is amending the undesignated introductory sentence to remove the term “common” for the same reasons as discussed above.

    § 373.103(a) & (b) Expense bills

    FMCSA makes three amendments related to the term “common” applicable to expense bills issued by for-hire motor carriers of property and charter service expense bills issued by for-hire motor carriers performing “charter transportation of passengers” as defined in § 390.5. FMCSA is also revising the heading of this section to add “for-hire, non-exempt” and is amending paragraphs (a) and (b) to remove the term “common” for the same reasons as discussed above.

    Part 374 Passenger Carrier Regulations

    The Agency makes several amendments to part 374 entitled Passenger Carrier Regulations. As discussed above, FMCSA adds a new § 374.1 Applicability section to ensure the public understands that part 374 is limited to for-hire motor carriers subject to jurisdiction in the ICCTA. Second, throughout part 374, FMCSA removes all references to “common” in headers and rule text in §§ 374.101, 374.103, 374.105, 374.107, 374.109, 374.111, 374.113, 374.201, 374.301, 374.303, 374.401, 374.403, and 374.405.

    Also, ICC never assigned a paragraph (b) to § 374.401, previously designated as 49 CFR 1064.1, when it was made final on November 16, 1979 (44 FR 65987) or in any amendments after 1979. With no paragraph (b), the section reads better and will be less confusing if paragraph (a) becomes an undesignated introductory phrase and paragraphs (a)(1), (2), and (3) are renamed as paragraphs (a), (b), and (c).

    Additionally, at the end of § 374.401, FMCSA removes the outdated authority citation “(49 U.S.C. 10321, 5 U.S.C. 553),” as it is a remnant of the pre-ICCTA statutes. Section 374.401's authority derives from the general authority cited for most of part 374—49 U.S.C. 13301 and 14101; and 49 CFR 1.87.

    Finally, the Agency amends four authority citations for incidental charter rights under subpart E to part 374 that are also outdated to show only ICCTA statutes—49 U.S.C. 13301, 13501, 13506, and their delegation under 49 CFR 1.87. In the first sentence in § 374.501, the outdated reference to “[49 U.S.C. 10932(c)]” is removed. The citation to 49 U.S.C. 13506 is correct and will remain in § 374.501.

    Part 376 Applicability of Lease and Interchange of Property-Carrying Motor Vehicles

    FMCSA makes several amendments related to the terms “common” and “contract” to part 376 applicable to the lease and interchange of property-carrying motor vehicles by for-hire motor carriers. In various places throughout part 376 that reference the term “motor common carrier” or “authorized common carrier” in the rule text, FMCSA removes all applicable references to “common.” The references to “common ownership” in part 376 have been retained as that concept is unaffected by this final rule.

    In § 376.1, FMCSA adds the clarifying phrase “. . . under 49 U.S.C. subtitle IV, part B:” to the introductory phrase in paragraph (a) to ensure the public understands these rules apply only to for-hire motor carriers subject to the ICCTA. In § 376.2, the term “motor common carrier” is amended to read as “motor carrier.”

    In the first four instances of the term “common” in § 376.31, FMCSA replaces “common” with the term “motor.”

    Part 377 Applicability of Payment of Transportation Charges

    In the applicability paragraph of § 377.101, FMCSA removes the term “common”; spells out cash-on-delivery for the acronym (c.o.d.); and reorganizes the paragraph to better show the two exceptions to the applicability of part 377.

    In §§ 377.103 and 377.105, the Agency replaces the term “common” with the term “motor” in each section.

    Part 377 Subpart B, Applicability of Extension of Credit to Shippers by Carriers and Freight Forwarders

    FMCSA makes several amendments related to the terms “common” and “contract” in subpart B of part 377 applicable to the extension of credit to shippers by for-hire motor carriers and freight forwarders. The Agency revises the heading for subpart B of part 377. The current title includes the term “common” and the phrase “Water Common Carriers.” The Agency adds the phrase “for-hire, non-exempt” before the phrase “motor carrier” in the subpart B heading as well as in § 377.201(a) to ensure exempt for-hire carriers understand the subpart does not apply to their extensions of credit to shippers. As FMCSA has never been delegated responsibility for regulating water carriers, the phrase “Water Common Carriers” is eliminated from the heading for subpart B as well.

    Also in § 377.201, FMCSA removes the exception for “Contract carrier operations” in paragraph (b)(1) and redesignates paragraphs (b)(2) and (3) as paragraphs (b)(1) and (2) for the reasons given above in the Background section. In § 377.217, the Agency replaces the term “common” with the term “motor.”

    Part 378 Applicability of Overcharge, Duplicate Payment, and Overcollection Claims Processing

    FMCSA makes two amendments related to the term “common” to part 378. In §§ 378.1 and 378.2, the Agency removes the term “common” in each of the two places it appears.

    §§ 382.103 and 383.3 Controlled Substances and Alcohol Testing and Commercial Driver's License (CDL) Rules, Applicability of an Exception for Farm Vehicle Employers and Drivers

    FMCSA makes two amendments related to the terms “common” and “contract” that are applicable to drivers that may need a CDL to drive a commercial motor vehicle (CMV) in the United States and whether that CDL driver is subject to controlled substances and alcohol testing. In § 382.103, FMCSA revises paragraph (d)(3)(i)(C) which discusses that an operator of a farm vehicle cannot be a common or contract motor carrier. The Agency replaces the phrase “common or contract motor carrier” with the phrase “for-hire motor carrier, except for an exempt motor carrier as defined in § 390.5 of this subchapter.” Similarly, an exception for operators needing a CDL to drive a farm vehicle excludes operations by a common or contract motor carrier. It is found in § 383.3(d)(3)(i)(C). In this paragraph, the Agency is also replacing the phrase “common or contract motor carrier” with the phrase “for-hire motor carrier, except for an exempt motor carrier as defined in § 390.5 of this subchapter.”

    These two changes will ensure that farmers, who also may operate as an exempt motor carrier, know that their farm vehicles might be excepted from the CDL and drug and alcohol testing requirements if the farm vehicles they use meets all of the other three conditions of the exception under § 382.103(d)(3)(i) and the CDL definition in § 383.3(d)(3)(i)(C).

    § 382.305 Controlled Substances Testing Annual Random Percentage Rate

    This amendment relates to the lowered minimum annual percentage rate for random controlled substances testing made effective for all testing in 2016 and later. FMCSA amends § 382.305(b)(2) to state that the minimum annual percentage rate for random controlled substances testing shall be 25 percent of the average number of driver positions, as it has been effective since January 1, 2016. On December 24, 2015 (80 FR 80446), FMCSA announced the reduction of the minimum annual percentage rate for random controlled substances testing for drivers of CMVs requiring a CDL from 50 percent of the average number of driver positions to 25 percent of the average number of driver positions, effective in calendar year 2016. The FMCSA Administrator has the discretion to decrease the minimum annual random testing percentage rate based on the reported positive random test rate for the entire motor carrier industry. Based on the controlled substances random test data in FMCSA's Management Information System (MIS) for calendar years 2011, 2012, and 2013, the positive rate for controlled substances random testing fell below the 1.0 percent threshold for 3 consecutive calendar years. As a result, the Agency lowered the controlled substances minimum annual percentage rate for random controlled substances testing to 25 percent of the average number of driver positions.

     § 383.5 School Bus Definition for Commercial Driver's License Standards

    The current definition of a school bus in § 383.5 does not include a bus used as a common carrier. In part 383, the term “school bus” is used only in the requirements under § 383.123 for a CDL driver to get a license endorsement after successfully passing knowledge and skills tests. FMCSA is replacing “common” with the phrase “for-hire motor”.

    § 383.77 Substitute for Driving Skills Tests for Drivers With Military CMV Experience

    FMCSA removes the erroneous second iteration of the word “had” in § 383.77(a)(5), making the sentence read, in part, as follows: “Has not had any conviction for a violation . . .”

    §§ 383.131 and 383.133 CDL Test System Model Commercial Driver Manual

    In §§ 383.131 and 383.133, FMCSA adds “or newer” after “July 2010” to allow each State to use newer manual editions to comply with the requirements. Each State must provide every CLP or CDL applicant an FMCSA pre-approved driver information manual as required by § 383.131. The manual must be comparable to the American Association of Motor Vehicle Administrators' (AAMVA's) “2005 CDL Test System Model Commercial Driver Manual,” July 2010 or a newer version. FMCSA provides the manual as a reference for States, but does not require any specific manual published after July 2010, nor does it incorporate any manual by reference into the regulations.

    § 384.401 State Compliance With CDL Program

    FMCSA amends § 384.401 to lower the withholding percentages of Federal-aid highway funds. Sec. 1404(j) of MAP-21 amended 49 U.S.C. 31314(c) changing the withholding percentages of Federal-aid highway funds based on State noncompliance with the CDL program. Federal-aid highway funds are apportioned to States under various sections of title 23 U.S.C. Amended sec. 1404(j) makes it necessary to revise the withholding provisions in § 384.401 to comply with amended 49 U.S.C. 31314(c). Specifically, MAP-21 changed the amount of Federal-aid highway funds to be withheld for noncompliance in paragraph (a) from 5 percent to 4 percent, and reduced the amount of such funds to be withheld for repeated noncompliance in paragraph (b) from 10 percent to 8 percent.

    § 384.407 Emergency CDL Grants

    FMCSA removes § 384.407 because SAFETEA-LU did not renew the emergency CDL grant program in 49 U.S.C. 31107. Therefore, this section is no longer necessary.

    § 385.303 New Entrant Motor Carrier Safety Assurance Applications

    FMCSA revises the universal resource locators (URL) to accurately reflect where to obtain the forms for new entrant motor carriers. Since December 2015, new applicants must apply for a USDOT number and if applicable, operating authority, by electronically filing Form MCSA-1, the URS online application. Registrants who had registered and been issued a USDOT number before December 2015 may still use form MCS-150 and if applicable, Form OP-1, to update their registration information.

    Similar to changes made earlier in this document for § 365.105, FMCSA is modifying how new entrant motor carriers may contact the Agency for application materials. In § 385.303, the Agency is changing a 703 area code fax number to a 202 area code fax number and is adding the option that new entrant motor carriers may locate application materials online at one of two Web pages, the precise location determined by whether they received a USDOT number before or after December 12, 2015.

    Part 385, Appendix B Restoration of Inadvertently Edited Safety Fitness Paragraph

    The Agency corrects an error made in 2005 to address an inadvertent change to a provision of appendix B to 49 CFR part 385. In the 1997 Safety Fitness Procedure; Safety Ratings final rule (62 FR 60035 at 60043 (Nov. 6, 1997)), paragraph (c) of the introductory text in app. B to part 385 read as follows: “To meet the safety fitness standard, a motor carrier must demonstrate to the FHWA that it has adequate safety management controls in place which function effectively to ensure acceptable compliance with the applicable safety requirements. A “safety fitness methodology” (SFRM) was developed by the FHWA, which uses data from compliance reviews (CRs) and roadside inspections to rate motor carriers.”

    In the same final rule, section II.(c), read as follows: “Critical regulations are those identified as such where noncompliance relates to management and/or operational controls. These are indicative of breakdowns in a carrier's management controls. An example of a critical regulation is § 395.3(a)(1), requiring or permitting a driver to drive more than 10 hours.”

    The reference to “FHWA” in paragraph (c) of the introductory text was changed to “FMCSA” in Miscellaneous Technical Amendments on Oct. 1, 2001 (66 FR 49867, at 49872) due to the establishment of the FMCSA by the Motor Carrier Safety Improvement Act of 1999.

    In the 2003 Hours of Service for Drivers final rule (68 FR 22456 at 22513 (Apr. 28, 2003)), section II.(c) was amended by FMCSA—the only change was to modify the time period at the end to “11 hours” from “10 hours” reflecting the amended provisions of § 395.3(a)(1). No change was directed to be made in paragraph (c) of the introductory text. This change in appendix B to 49 CFR part 385, section II.(c) was correctly published in the 2004 Code of Federal Regulations and no change was made in paragraph (c) of the introductory text. See 49 CFR part 385, app. B (10/01/2004 ed.), at pages 1023-24.

    In the 2005 Hours of Service for Drivers final rule (70 FR 49978 at 50070 (Aug. 25, 2005)), FMCSA again directed that section II.(c) be revised to refer to “11 hours” even though that change had already been published in the CFR. But no change was directed to be made in paragraph (c) of the introductory text. Nonetheless, in the 2005 compilation of the CFR, the revised text of section II.(c) was published in two places: (1) in place of the text in paragraph (c) of the introductory text, which the Agency did not intend to change; and (2) in section II.(c), which was the only place that the final rule directed that a change be made. See 49 CFR part 385, app. B (10/01/2005 ed.),6 at pages 239-240.

    6 See https://www.thefederalregister.org/fdsys/pkg/CFR-2005-title49-vol5/pdf/CFR-2005-title49-vol5-part385-appB.pdf.

    This amendment corrects the error in the CFR and does not impose any new requirements; it just restores the proper paragraph (c) of the introductory text to read as set out in the regulatory text at the end of this document.

    FMCSA is also republishing section II.(c) as it was correctly published in the 2004 and 2005 CFRs to give context.

    FMCSR Errors Resulting From Electronic Logging Devices and Hours of Service Supporting Documents Final Rule

    Four amendments are being made to the 2015 Electronic Logging Devices and Hours of Service Supporting Documents (ELD) final rule, December 16, 2015 (80 FR 78292, at 78381) below. The amendments are to two critical regulations in part 385, appendix B, the filing of various complaints under § 386.1, and adding an additional qualifying phrase to § 395.8(a)(1)(iii)(A)(3) about how to determine whether a commercial motor vehicle was manufactured before model year 2000.

    Part 385, Appendix B List of Critical and Acute Regulations

    While reviewing the list of acute and critical regulations, found in appendix B of part 385, FMCSA discovered that the terminology used to identify two of the critical violations is confusing. In these provisions, the critical violations occur when a motor carrier fails to ensure that drivers (or third parties) submit records of duty status (or supporting documents); while there is still a violation if those documents are submitted late, late submissions are not typically critical violations that could affect the motor carrier's safety rating. It is only when the motor carrier fails completely to require drivers to submit the documents that such an effect could occur. Thus, the two provisions described above that are identified as critical regulations in section VII. List of Acute and Critical Regulations in appendix B, are being revised to remove the words “in a timely manner,” as set out below:

    • § 395.8(a)(2)(ii) Failure to require a driver to submit record of duty status (critical); and • § 395.11(b) Failing to require a driver to submit supporting documents (critical) This change reflects the way that FMCSA treats violations currently, and will therefore have no direct impact on motor carriers. § 386.1  Filing of Substantial Complaints, Filing of Harassment Complaints, and Filing of Coercion Complaints

    In the same 2015 ELD rule, FMCSA changed § 386.1, Scope of rules in this part, to include references to complaints of substantial violation, coercion, and harassment. However, the Agency overlooked the recent addition of a new paragraph § 386.1(c) in its separate Coercion final rule 7 published two weeks before the ELD rule, and made the amendatory instruction incorrectly. To correct this inadvertent error, this technical amendment adds new § 386.1(c)(1), (2), and (3), as was explained in the amendatory instructions of the ELD rule. New § 386.1(c)(1), (2), and (3) concern the filing of substantial complaints, the filing of harassment complaints, and the filing of coercion complaints, respectively. Similarly, the ELD rule failed to modify a reference to the coercion complaint process made necessary by the rule's restructuring of § 386.12. This rule corrects the applicable cross-reference in § 390.6(b)(1), replacing the reference to § 386.12(e) with § 386.12(c).

    7 November 30, 2015 (80 FR 74695, at 74709).

    § 391.42 Schedule for Use of Medical Examiners Listed on the National Registry

    FMCSA removes § 391.42. The requirement that all medical examinations performed “on or after May 21, 2014 . . . must be conducted by a medical examiner” listed on the National Registry is not necessary as it duplicates the requirements in § 391.43.

    § 391.43 Medical Examination and Certificate of Physical Examination

    FMCSA makes several amendments to a driver's medical exam, the form used to record the results of the exam, and the certificate issued upon completion of the exam. FMCSA amends § 391.43(a) to remove the reference to § 391.42, which is being deleted as discussed above.

    The Agency also amends paragraph (f), first by removing paragraph (f)(1) because the use of the previous form authorized by that paragraph is no longer permitted. Second, the remaining text (from paragraph (f)(2) which went into effect on December 22, 2015) is revised to remove the effective date. Third, the latest approved version of Medical Examination Report (MER) Form, MCSA-5875 replaces the previous version.

    Similar changes are made in paragraph (h) of § 391.43. First, FMCSA removes paragraph (h)(1) because the use of the previous form authorized by that paragraph is no longer permitted. Second, the Agency revises the remaining text (from paragraph (h)(2) which went into effect on December 22, 2015) to remove the effective date. Third, the Agency updates the version of Medical Examiner's Certificate (MEC) Form, MCSA-5876. Both the MER and MEC forms have been approved by OMB for use through August 31, 2018, under OMB number 2126-0006.

    § 392.9b Safety Registration

    FMCSA revises the heading for paragraph (a) in § 392.9b, as well as the text within paragraph (a) to replace the term “USDOT Registration” with “safety registration.” This change should have been made as part of the Unified Registration System rule that was published on August 23, 2013 (78 FR 52608), and it should have gone into effect along with other changes to this section on November 1, 2013. FMCSA revises the term to conform to the terminology that is currently in place within the Unified Registration System, where there is no “USDOT Registration.” Rather, there are USDOT numbers, operating authority registration, and safety registration. As a result, this change should have no impact on the type of registrations that a motor carrier could receive from FMCSA.

    § 395.1 Restoration of Supporting Documents Exception for 100 Air-Mile Radius Drivers

    FMCSA revises § 395.1(e)(1) to restore the supporting documents exception for 100 air-mile radius drivers inadvertently removed by a FAST Act final rule 8 published on July 22, 2016. The ELD 9 rule added the supporting documents exception for 100 air-mile radius drivers, but the FAST Act rule inadvertently removed it when FMCSA revised § 395.1(e)(1) to add new 49 U.S.C. 31502(f)(1) that exempts drivers of ready-mixed concrete delivery vehicles from keeping records of duty status under certain circumstances. FMCSA revises the introductory text of paragraph (e)(1) to restore it to read as set out in the regulatory text at the end of this document.

    8Amendments To Implement Certain Provisions of the Fixing America's Surface Transportation Act or “FAST Act,” July 22, 2016 (81 FR 47714, at 47721).

    9Electronic Logging Devices and Hours of Service Supporting Documents final rule, December 16, 2015 (80 FR 78292, at 78381).

    § 395.8 Driver's Record of Duty Status

    Since publication of the ELD rule in December 2015, FMCSA has received a significant number of questions asking how a motor carrier can determine whether a commercial motor vehicle was manufactured before model year 2000, thus allowing its driver to use paper records of duty status instead of the ELD required in most other cases. FMCSA amends § 395.8 to include an additional qualifying phrase to paragraph (a)(1)(iii)(A)(4) inserted after “model year 2000.” The model year 2000 will be determined during roadside inspections “as reflected in the vehicle identification number as shown on the vehicle's registration.” The vehicle identification number includes the model year. This will be particularly useful in light of the installation of truck-tractor glider kits. This technical correction eliminates any ambiguity.

    § 397.73 Hazardous Material (HM) Public Information and Reporting Requirements

    FMCSA provides routing agencies with an alternative email address for reporting changes to their HM route registries. Each State and Indian tribe, through its routing agency, must provide information to FMCSA under § 397.73 identifying all non-radioactive hazardous material (NRHM) routing designations that exist within its jurisdiction. A similar requirement in § 397.103 requires reporting of preferred routes for highway route controlled shipments of radioactive materials. FMCSA is adding an optional, electronic way to send FMCSA the required information in both sections. Currently the regulation restricts transmittal to an address using certified mail, return receipt requested.

    § 397.101 Highway-Route Controlled Quantity Shipments of Radioactive Materials

    Currently, § 397.101 requires each carrier that accepts for transportation a highway route controlled quantity of hazardous material, as defined in 49 CFR 173.403, to file certain information with FMCSA after accepting the package for transportation. FMCSA no longer uses this information, and therefore removes paragraph (g) from § 397.101.

    § 398.1 Transportation of Migrant Workers

    FMCSA amends the definition of a migrant worker motor carrier to be consistent with the ICCTA's elimination of the terms “contract” and “common” in the phrases “contract carrier by motor vehicle” and “common carrier by motor vehicle.” FMCSA revises the definition to read as set out in the regulatory text at the end of this document.

    Rulemaking Analyses Executive Order 12866 (Regulatory Planning and Review) and DOT Regulatory Policies and Procedures

    FMCSA has determined that this action is not a significant regulatory action within the meaning of Executive Order 12866, as supplemented by Executive Order 13563 (76 FR 3821, Jan. 18, 2011), or within the meaning of the DOT regulatory policies and procedures (44 FR 1103, Feb. 26, 1979). Thus, the Office of Management and Budget (OMB) did not review this document. We expect the final rule will have no costs; therefore, a full regulatory evaluation is unnecessary.

    Regulatory Flexibility Act

    Pursuant to the Regulatory Flexibility Act (RFA) of 1980 (5 U.S.C. 601 et seq.), as amended by the Small Business Regulatory Enforcement Fairness Act of 1996 (Pub. L. 104-121, 110 Stat. 857), FMCSA is not required to prepare a final regulatory flexibility analysis under 5 U.S.C. 604(a) for this final rule because the Agency has not issued a notice of proposed rulemaking prior to this action. FMCSA has determined that it has good cause to adopt the rule without notice and comment.

    Unfunded Mandates Reform Act

    The final rule will not impose an unfunded Federal mandate, as defined by the Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1532, et seq.), that will result in the expenditure by State, local and tribal governments, in the aggregate, or by the private sector, of $155 million (which is the value of $100 million in 2015 after adjusting for inflation) or more in any 1 year.

    E.O. 13132 (Federalism)

    A final rule has implications for Federalism under section 1(a) of Executive Order 13132 if it has “substantial direct effects on the States, on the relationship between national government and the States, or on the distribution of power and responsibilities among various levels of government.” FMCSA has determined that this rule will not have substantial direct effects on States, nor will it limit the policymaking discretion of States. Nothing in this document preempts or modifies any provision of State law or regulation, imposes substantial direct unreimbursed compliance costs on any State, or diminishes the power of any State to enforce its own laws. Accordingly, this rulemaking does not have Federalism implications warranting the application of E.O. 13132.

    E.O. 12372 (Intergovernmental Review)

    The regulations implementing E.O. 12372 regarding intergovernmental consultation on Federal programs and activities do not apply to this rule.

    Indian Tribal Governments

    This final rule does not have tribal implications under Executive Order 13175 titled, “Consultation and Coordination with Indian Tribal Governments,” because it would not have a substantial direct effect on one or more Indian tribes, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes.

    Paperwork Reduction Act

    Under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501 et seq.), Federal agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct, sponsor, or require through regulations. FMCSA determined that no new information collection requirements are associated with this final rule, nor are there any revisions to existing, approved collections of information. Therefore, the PRA does not apply to this final rule.

    National Environmental Policy Act

    FMCSA analyzed this final rule for the purpose of ascertaining the applicability of the National Environmental Policy Act of 1969 (42 U.S.C. 4321 et seq.) and determined under our Environmental Procedures Order 5610.1, issued March 1, 2004 (69 FR 9680), that this action would not have any effect on the quality of the environment. In addition, this final rule is categorically excluded from further analysis and documentation under the Categorical Exclusion (CE) in paragraph 6(b) of Appendix 2 of FMCSA Order 5610.1. This CE addresses minor editorial corrections such as those found in this rulemaking; therefore, preparation of an environmental assessment or environmental impact statement is not necessary.

    FMCSA also analyzed this rule under the Clean Air Act, as amended (CAA), section 176(c) (42 U.S.C. 42 U.S.C. 7506(c)), and implementing regulations promulgated by the Environmental Protection Agency. Approval of this action is exempt from the CAA's general conformity requirement since it does not affect direct or indirect emissions of criteria pollutants.

    E.O. 12898 (Environmental Justice)

    This final rule is not subject to Executive Order 12898 (59 FR 7629, Feb. 16, 1994). Executive Order 12898 establishes Federal executive policy on environmental justice. Its main provision directs Federal agencies to make environmental justice part of their mission by identifying and addressing, as appropriate, disproportionately high and adverse human health or environmental effects of their programs, policies, and activities on minority populations and low-income populations in the United States. FMCSA determined that this rule will not have disproportionately high and adverse human health or environmental effects on minority or low-income populations because it does not change the substance of any of the FMCSRs.

    E.O. 13211 (Energy Effects)

    FMCSA has analyzed this final rule under Executive Order 13211 titled, “Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use.” The Agency has determined that it is not a “significant energy action” under that Executive Order because it is not a “significant regulatory action” under Executive Order 12866 and is not likely to have a significant adverse effect on the supply, distribution, or use of energy. Therefore, no Statement of Energy Effects is required.

    E.O. 13045 (Protection of Children)

    Executive Order 13045 titled, “Protection of Children from Environmental Health Risks and Safety Risks” (62 FR 19885, Apr. 23, 1997), requires agencies issuing “economically significant” rules, if the regulation also concerns an environmental health or safety risk that an agency has reason to believe may disproportionately affect children, to include an evaluation of the regulation's environmental health and safety effects on children. As discussed previously, this rule is not economically significant. Therefore, no analysis of the impacts on children is required. Nevertheless, as this final rule does not change the substance of any of the FMCSRs, FMCSA does not believe it will have any environmental health or safety impacts on children.

    E.O. 12988 (Civil Justice Reform)

    This action meets applicable standards in sections 3(a) and 3(b)(2) of E.O. 12988 titled, “Civil Justice Reform,” to minimize litigation, eliminate ambiguity, and reduce burden.

    E.O. 12630 (Taking of Private Property)

    This final rule will not effect a taking of private property or otherwise have taking implications under E.O. 12630 titled, “Governmental Actions and Interference with Constitutionally Protected Property Rights.”

    National Technology Transfer and Advancement Act

    The National Technology Transfer and Advancement Act (15 U.S.C. 272 note) requires Federal agencies proposing to adopt technical standards to consider whether voluntary consensus standards are available. If the Agency chooses to adopt its own standards in place of existing voluntary consensus standards, it must explain its decision in a separate statement to OMB. Because this final rule does not adopt technical standards, there is no need to submit a separate statement to OMB on this matter.

    Privacy Impact Assessment

    Section 522(a)(5) of the Transportation, Treasury, Independent Agencies, and General Government Appropriations Act, 2005 (Pub. L. 108- 447, Division H, Title I, 118 Stat. 2809 at 3268, Dec. 8, 2004) requires DOT and certain other Federal agencies to conduct a privacy impact assessment of each rule that will affect the privacy of individuals. Because this final rule will not affect the privacy of individuals, FMCSA did not conduct a separate privacy impact assessment.

    List of Subjects 49 CFR Part 355

    Highway safety, Intergovernmental relations, Motor carriers, Motor vehicle safety, Reporting and recordkeeping requirements.

    49 CFR Part 356

    Administrative practice and procedure, Freight forwarders, Highways and roads, Motor carriers.

    49 CFR Part 365

    Administrative practice and procedure, Brokers, Buses, Freight forwarders, Maritime carriers, Mexico, Motor carriers, Moving of household goods.

    49 CFR Part 369

    Motor carriers, Reporting and recordkeeping requirements.

    49 CFR Part 370

    Freight forwarders, Investigations, Motor carriers.

    49 CFR Part 373

    Buses, Freight, Freight forwarders, Motor carriers, Moving of household goods.

    49 CFR Part 374

    Aged, Blind, Buses, Civil rights, Freight, Individuals with disabilities, Motor carriers, Smoking.

    49 CFR Part 376

    Motor carriers, Reporting and recordkeeping requirements.

    49 CFR Part 377

    Credit, Freight forwarders, Maritime carriers, Motor carriers, Moving of household goods.

    49 CFR Part 378

    Freight forwarders, Investigations, Motor carriers, Motor of household goods.

    49 CFR Part 382

    Administrative practice and procedure, Alcohol abuse, Drug abuse, Drug testing, Highway safety, Motor carriers, Penalties, Safety, Transportation.

    49 CFR Part 383

    Administrative practice and procedure, Alcohol abuse, Drug abuse, Highway safety, Motor carriers.

    49 CFR Part 384

    Administrative practice and procedure, Alcohol abuse, Drug abuse, Highway safety, Motor carriers.

    49 CFR Part 385

    Administrative practice and procedure, Highway safety, Mexico, Motor carriers, Motor vehicle safety, Reporting and recordkeeping requirements.

    49 CFR Part 386

    Administrative practice and procedure, Brokers, Freight forwarders, Hazardous materials transportation, Highway safety, Motor carriers, Motor vehicle safety, Penalties.

    49 CFR Part 390

    Highway safety, Intermodal transportation, Motor carriers, Motor vehicle safety, Reporting and recordkeeping requirements.

    49 CFR Part 391

    Alcohol abuse, Drug abuse, Drug testing, Highway safety, Motor carriers, Reporting and recordkeeping requirements, Safety, Transportation.

    49 CFR Part 392

    Alcohol abuse, Drug abuse, Highway safety, Motor carriers.

    49 CFR Part 395

    Highway safety, Motor carriers, Reporting and recordkeeping requirements.

    49 CFR Part 397

    Administrative practice and procedure, Hazardous materials transportation, Highway safety, Intergovernmental relations, Motor carriers, Parking, Radioactive materials, Reporting and recordkeeping requirements, Rubber and rubber products.

    49 CFR Part 398

    Highway safety, Migrant labor, Motor carriers, Motor vehicle safety, Reporting and recordkeeping requirements.

    In consideration of the foregoing, FMCSA is amending 49 CFR chapter III, subchapter B, parts 355, 356, 365, 369, 370, 373, 374, 376, 377, 378, 382, 383, 384, 385, 386, 390, 391, 392, 395, 397, and 398, as set forth below:

    PART 355—COMPATIBILITY OF STATE LAWS AND REGULATIONS AFFECTING INTERSTATE MOTOR CARRIER OPERATIONS 1. The authority citation for part 355 continues to read as follows: Authority:

    49 U.S.C. 504 and 31101 et seq.; and 49 CFR 1.87.

    2. Revise the applicability section of appendix A to part 355 to read as follows: Appendix A to Part 355—Guidelines for the Regulatory Review Applicability

    The requirements must apply to all segments of the motor carrier industry, for-hire and private carriers of property and for-hire carriers of passengers.

    PART 356—MOTOR CARRIER ROUTING REGULATIONS 3. The authority citation for part 356 continues to read as follows: Authority:

    5 U.S.C. 553; 49 U.S.C. 13301 and 13902; and 49 CFR 1.87.

    § 356.7 [Removed]
    4. Remove § 356.7.
    § 356.9 [Removed]
    5. Remove § 356.9.
    § 356.11 [Removed]
    6. Remove § 356.11.
    § 356.13 [Removed]
    7. Remove § 356.13. PART 365—RULES GOVERNING APPLICATIONS FOR OPERATING AUTHORITY 8. The authority citation for part 365 continues to read as follows: Authority:

    5 U.S.C. 553 and 559; 49 U.S.C. 13101, 13301, 13901-13906, 14708, 31138, and 31144; sec. 5524 of Pub. L. 114-94, 129 Stat. 1312, 1560; and 49 CFR 1.87.

    9. Amend § 365.105 by revising paragraph (b) to read as follows:
    § 365.105 Starting the application process: Form OP-1.

    (b) Obtain forms at a FMCSA Division Office in each State or at one of the FMCSA Service Centers. Addresses and phone numbers for the Division Offices and Service Centers can be found at: https://www.fmcsa.dot.gov/mission/field-offices. The forms and information about filing procedures can be downloaded at: https://www.fmcsa.dot.gov/registration/registration-forms.

    10. Amend § 365.205 by revising paragraph (d) to read as follows:
    § 365.205 Contents of the protest.

    (d) Protests must respond directly to the statutory standards for FMCSA review of the application. As these standards vary for particular types of applications, potential protestants should refer to the general criteria addressed at § 365.107 and may consult the FMCSA at 800-832-5660 or via the web form at https://www.fmcsa.dot.gov/ask for further assistance in developing their evidence.

    11. Amend § 365.413 by revising paragraph (b) and adding paragraph (c) to read as follows:
    § 365.413 Procedures for changing the name or business form of a motor carrier, freight forwarder, or property broker.

    (b) Procedures. To accomplish these changes, a letter or signed copy of form MCSA-5889, “Motor Carrier Records Change Form,” OMB No. 2126-0060, must be submitted to the Federal Motor Carrier Safety Administration. It must be submitted in one of the following three ways.

    (1) Scanned and submitted via the web form at https://www.fmcsa.dot.gov/ask;

    (2) Faxed to (202-366-3477); or

    (3) Mailed to the Federal Motor Carrier Safety Administration, Office of Registration and Safety Information (MC-RS), 1200 New Jersey Ave. SE., Washington, DC 20590-0001. The envelope should be marked “NAME CHANGE”.

    (c) The registrant must provide:

    (1) The docket number(s) and name of the carrier, freight forwarder, or property broker requesting the change;

    (2) A copy of the articles of incorporation and the State certificate reflecting the incorporation;

    (3) The name(s) of the owner(s) of the stock and the distribution of the shares;

    (4) The names of the officers and directors of the corporation; and

    (5) A statement that there is no change in the ownership, management, or control of the business. When this procedure is being used to transfer operating rights from a deceased or incapacitated spouse to the other spouse, documentation that the other spouse has the legal right to effect such change must be included with the request. The fee for filing a name change request is in § 360.3(f) of this chapter.

    PART 369—REPORTS OF MOTOR CARRIERS 12. The authority citation for part 369 continues to read as follows: Authority:

    49 U.S.C. 14123; 49 CFR 1.87.

    13. Amend § 369.1 by revising the heading and paragraph (a) to read as follows:
    § 369.1 Annual reports of for-hire, non-exempt motor carriers of property, motor carriers of household goods, and dual property carriers.

    (a) Annual Report Form M. All class I and class II for-hire, non-exempt motor carriers of property, including household goods and dual property motor carriers, must file Motor Carrier Annual Report Form M (Form M). Carriers must file the annual report on or before March 31 of the year following the year to which it relates. For classification criteria, see § 369.2.

    14. Amend § 369.2 by revising the heading and the introductory text of paragraph (a) to read as follows:
    § 369.2 Classification of carriers—for-hire, non-exempt motor carriers of property, household goods carriers, and dual property carriers.

    (a) For-hire, non-exempt motor carriers of property are grouped into the following three classes:

    15. Amend § 369.3 by revising the heading and the introductory text of paragraph (a) to read as follows:
    § 369.3 Classification of carriers—for-hire, non-exempt motor carriers of passengers.

    (a) For-hire, non-exempt motor carriers of passengers are grouped into the following two classes:

    PART 370—PRINCIPLES AND PRACTICES FOR THE INVESTIGATION AND VOLUNTARY DISPOSITION OF LOSS AND DAMAGE CLAIMS AND PROCESSING SALVAGE 16. The authority citation for part 370 continues to read as follows: Authority:

    49 U.S.C. 13301 and 14706; and 49 CFR 1.87.

    17. Amend § 370.9 by revising paragraph (b) to read as follows:
    § 370.9 Disposition of claims.

    (b) When settling a claim for loss or damage, a household goods motor carrier as defined in § 375.103 of this subchapter shall use the replacement costs of the lost or damaged item as a base to apply a depreciation factor to arrive at the current actual value of the lost or damaged item.

    PART 373—RECEIPTS AND BILLS 18. The authority citation for part 373 continues to read as follows: Authority:

    49 U.S.C. 13301, 13531, and 14706; and 49 CFR 1.87.

    19. Add § 373.100 to read as follows:
    § 373.100 Applicability.

    This subpart applies to motor carriers subject to 49 U.S.C. subtitle IV, part B (secs. 13101-14916).

    20. Amend § 373.101 by revising the heading and introductory text to read as follows:
    § 373.101 For-hire, non-exempt motor carrier bills of lading.

    Every motor carrier subject to § 373.100 shall issue a receipt or bill of lading for property tendered for transportation in interstate or foreign commerce containing the following information:

    21. Amend § 373.103 by revising the heading and paragraphs (a) introductory text and (b) introductory text to read as follows:
    § 373.103 For-hire, non-exempt expense bills.

    (a) Property. Every for-hire, non-exempt motor carrier shall issue a freight or expense bill for each shipment transported containing the following information:

    (b) Charter transportation of passenger service. Every for-hire, non-exempt motor carrier providing charter transportation of passenger service shall issue an expense bill containing the following information:

    PART 374— PASSENGER CARRIER REGULATIONS 22. The authority citation for part 374 continues to read as follows: Authority:

    49 U.S.C. 13301 and 14101; and 49 CFR 1.87.

    23. Add § 374.1 before subpart A to read as follows:
    § 374.1 Applicability.

    This part applies to motor carriers subject to 49 U.S.C. subtitle IV, part B (secs. 13101-14916).

    24. Revise the heading for subpart A to read as follows: Subpart A—Discrimination in Operations of Interstate Motor Carriers of Passengers
    § 374.101 [Amended]
    25. In § 374.101, remove the word “common”.
    § 374.103 [Amended]
    26. In § 374.103, remove the word “common”.
    § 374.105 [Amended]
    27. In § 374.105, remove the word “common”.
    § 374.107 [Amended]
    28. In § 374.107, remove the word “common” and the word “Common”.
    § 374.109 [Amended]
    29. In § 374.109, remove the word “common”.
    § 374.111 [Amended]
    30. In § 374.111, remove the word “common”.
    § 374.113 [Amended]
    31. In § 374.113, paragraph (a), remove the word “common”.
    § 374.201 [Amended]
    32. In § 374.201, remove the word “common”.
    33. Revise the heading for subpart C to read as follows: Subpart C—Adequacy of Intercity Motor Carrier Passenger Service
    § 374.301 [Amended]
    34. In § 374.301, remove the word “common”.
    § 374.303 [Amended]
    35. In § 374.303, paragraph (a), remove the word “common”. 36. Revise § 374.401 to read as follows:
    § 374.401 Minimum permissible limitations for baggage liability.

    Motor carriers of passengers and baggage subject to 49 U.S.C. 13501 may not publish tariff provisions limiting their liability for loss or damage to baggage checked by a passenger transported in regular route or special operations unless:

    (a) The amount for which liability is limited is $250 or greater per adult fare; and

    (b) The provisions permit the passenger, for an additional charge, to declare a value in excess of the limited amount, and allow the passenger to recover the increased amount (but not higher than the actual value) in event of loss or damage. The carriers may publish a maximum value for which they will be liable, but that maximum value may not be less than $1,000. Appropriate identification must be attached securely by the passenger to each item of baggage checked, indicating in a clear and legible manner the name and address to which the baggage should be forwarded if lost and subsequently recovered. Identification tags shall be made immediately available by the carriers to passengers upon request.

    (c) Carriers need not offer excess value coverage on articles listed in § 374.307(c)(3).

    § 374.403 [Amended]
    37. In § 374.403, paragraph (a), remove the word “common”.
    § 374.405 [Amended]
    38. In § 374.405, remove the word “common”. Subpart E—Incidental Charter Rights 39. The authority citation for subpart E to part 374 is revised to read as follows: Authority:

    49 U.S.C. 13301, 13501, 13506; and 49 CFR 1.87.

    § 374.501 [Amended]
    40. Amend § 374.501 by removing “[49 U.S.C. 10932(c)]”. PART 376—LEASE AND INTERCHANGE OF VEHICLES 41. The authority citation for part 376 continues to read as follows: Authority:

    49 U.S.C. 13301 and 14102; and 49 CFR 1.87.

    42. Amend § 376.1 by revising the introductory text and paragraph (c) to read as follows:
    § 376.1 Applicability.

    The regulations in this part apply to the following actions by motor carriers registered with the Secretary to transport property under 49 U.S.C. subtitle IV, part B:

    (c) The interchange of equipment between for-hire motor carriers in the performance of transportation regulated by the Secretary.

    § 376.2 [Amended]
    43. Amend § 376.2 by removing the term “common” in paragraph (c). 44. Amend § 376.31 as follows: a. Revise the introductory text; and b. Revise the introductory text of paragraph (d), the first sentence of paragraph (d)(1), and the first sentence of paragraph (d)(2).

    The revisions read as follows:

    § 376.31 Interchange of equipment.

    Authorized for-hire motor carriers may interchange equipment under the following conditions:

    (d) Identification of equipment. The authorized for-hire motor carrier receiving the equipment shall identify equipment operated by it in interchange service as follows:

    (1) The authorized for-hire motor carrier shall identify power units in accordance with FMCSA's requirements in 49 CFR part 390 (Identification of Vehicles). * * *

    (2) Unless a copy of the interchange agreement is carried on the equipment, the authorized for-hire motor carrier shall carry a statement with each vehicle during interchange service certifying that it is operating the equipment. * * *

    PART 377—PAYMENT OF TRANSPORTATION CHARGES 45. The authority citation for part 377 continues to read as follows: Authority:

    49 U.S.C. 13101, 13301, 13701, 13702, 13706, 13707, and 14101; and 49 CFR 1.87.

    46. Revise § 377.101 to read as follows:
    § 377.101 Applicability.

    (a) Applicability. The rules and regulations in this part apply to the transportation by motor vehicle of cash-on-delivery (c.o.d.) shipments by all for-hire motor carriers of property subject to 49 U.S.C. 13702.

    (b) Exceptions. (1) The rules in this part do not apply to transportation which is auxiliary to or supplemental of transportation by railroad and performed on railroad bills of lading.

    (2) The rules in this part do not apply to transportation which is performed for freight forwarders and on freight forwarder bills of lading.

    § 377.103 [Amended]
    47. Amend § 377.103 by removing the term “common” and adding in its place the term “motor”.
    § 377.105 [Amended]
    48. Amend § 377.105 by removing the term “common” and adding in its place the term “motor”. 49. Revise the heading to subpart B of part 377 to read as follows: Subpart B—Extension of Credit to Shippers by For-Hire, Non-Exempt Motor Carriers and Household Goods Freight Forwarders 50. Revise § 377.201 to read as follows:
    § 377.201 Scope.

    (a) General. These regulations apply to the extension of credit in the transportation of property under Federal Motor Carrier Safety Administration regulation by for-hire, non-exempt motor carriers and household goods freight forwarders subject to 49 U.S.C. subtitle IV, part B, except as otherwise provided.

    (b) Exceptions. These regulations do not apply to—

    (1) Transportation for—

    (i) The United States or any department, bureau, or agency thereof;

    (ii) Any State or political subdivision thereof; or

    (iii) The District of Columbia.

    (2) Property transportation incidental to passenger operations.

    § 377.217 [Amended]
    51. Amend § 377.217 by removing the term “common” and adding in its place the term “motor”. PART 378—PROCEDURES GOVERNING THE PROCESSING, INVESTIGATION, AND DISPOSITION OF OVERCHARGE, DUPLICATE PAYMENT, OR OVERCOLLECTION CLAIMS 52. The authority citation for part 378 continues to read as follows: Authority:

    49 U.S.C. 13321, 14101, 14704 and 14705; and 49 CFR 1.87.

    § 378.1 [Amended]
    53. Amend § 378.1 by removing the term “common”.
    § 378.2 [Amended]
    54. Amend § 378.2 by removing the term “common” in paragraph (a). PART 382—CONTROLLED SUBSTANCES AND ALCOHOL USE AND TESTING 55. The authority citation for part 382 continues to read as follows: Authority:

    49 U.S.C. 31133, 31136, 31301 et seq., 31502; sec. 32934 of Pub. L. 112-141, 126 Stat. 405, 830; and 49 CFR 1.87.

    56. Amend § 382.103 by revising paragraph (d)(3)(i)(C) to read as follows:
    § 382.103 Applicability.

    (d) * * *

    (3) * * *

    (i) * * *

    (C) Not used in the operations of a for-hire motor carrier, except for an exempt motor carrier as defined in § 390.5 of this subchapter;

    § 382.305 [Amended]
    57. In § 382.305, amend paragraph (b)(2) by removing “50 percent” and adding in its place “25 percent”. PART 383—COMMERCIAL DRIVER'S LICENSE STANDARDS; REQUIREMENTS AND PENALTIES 58. The authority citation for part 383 continues to read as follows: Authority:

    49 U.S.C. 521, 31136, 31301 et seq., and 31502; secs. 214 and 215 of Pub. L. 106-159, 113 Stat. 1748, 1766, 1767; sec. 1012(b) of Pub. L. 107-56, 115 Stat. 272, 297, sec. 4140 of Pub. L. 109-59, 119 Stat. 1144, 1746; sec. 32934 of Pub. L. 112-141, 126 Stat. 405, 830; sec. 7208 of Pub. L. 114-94, 129 Stat. 1312, 1593; and 49 CFR 1.87.

    59. Amend § 383.3 by revising paragraph (d)(1)(iii) to read as follows:
    § 383.3 Applicability.

    (d) * * *

    (1) * * *

    (iii) Not used in the operations of a for-hire motor carrier, except for an exempt motor carrier as defined in § 390.5 of this subchapter;

    60. Amend § 383.5 by revising the definition of School bus to read as follows:
    § 383.5 Definitions.

    School bus means a CMV used to transport pre-primary, primary, or secondary school students from home to school, from school to home, or to and from school-sponsored events. School bus does not include operations of a for-hire motor carrier.

    61. Amend § 383.77 by revising paragraph (a)(5) to read as follows:
    § 383.77 Substitute for driving skills tests for drivers with military CMV experience.

    (a) * * *

    (5) Has not had any conviction for a violation of military, State or local law relating to motor vehicle traffic control (other than a parking violation) arising in connection with any traffic accident, and has no record of an accident in which he/she was at fault; and

    § 383.131 [Amended]
    62. Amend § 383.131 by removing all references to “July 2010” and adding in its place the phrase “July 2010 or newer”.
    § 383.133 [Amended]
    63. Amend § 383.133 by removing all references to “July 2010” and adding in its place the phrase “July 2010 or newer”. PART 384—STATE COMPLIANCE WITH COMMERCIAL DRIVER'S LICENSE PROGRAM 64. The authority citation for part 384 is continues to read as follows: Authority:

    49 U.S.C. 31136, 31301, et seq., and 31502; secs. 103 and 215 of Pub. L. 106-59, 113 Stat. 1753, 1767; and 49 CFR 1.87.

    65. Revise § 384.401 to read as follows:
    § 384.401 Withholding of funds based on noncompliance.

    (a) Following the first year of noncompliance. An amount up to 4 percent of the Federal-aid highway funds required to be apportioned to any State under each of sections 104(b)(1), (b)(3), and (b)(4) of title 23 U.S.C. shall be withheld from a State on the first day of the fiscal year following such State's first year of noncompliance under this part.

    (b) Following second and subsequent year(s) of noncompliance. An amount up to 8 percent of the Federal-aid highway funds required to be apportioned to any State under each of sections 104(b)(1), (b)(3), and (b)(4) of title 23 U.S.C. shall be withheld from a State on the first day of the fiscal year following such State's second or subsequent year(s) of noncompliance under this part.

    § 384.407 [Removed and Reserved]
    66. Remove and reserve § 384.407. PART 385—SAFETY FITNESS PROCEDURES 67. The authority citation for part 385 continues to read as follows: Authority:

    49 U.S.C. 113, 504, 521(b), 5105(d), 5109, 13901-13905, 31133, 31135, 31136, 31137, 31144, 31148, and 31502; Sec. 113(a), Pub. L. 103-311; Sec. 408, Pub. L. 104-88, 109 Stat. 803, 958; Sec. 350, Pub. L. 107-87; and 49 CFR 1.87.

    68. Revise § 385.303 to read as follows:
    § 385.303 How does a motor carrier register with the FMCSA?

    A motor carrier may contact the FMCSA by internet (www.fmcsa.dot.gov); or Washington, DC headquarters by mail at, Federal Motor Carrier Safety Administration, 1200 New Jersey Ave. SE., Washington, DC 20590-0001; fax 202-366-3477; or telephone 1-800-832-5660, and request the application materials for a new entrant motor carrier. Forms can also be downloaded from https://www.fmcsa.dot.gov/registration/registration-forms. A motor carrier which does not already have a USDOT number must apply online via the Unified Registration System (URS) at www.fmcsa.dot.gov/urs.

    69. Amend appendix B to part 385 as follows: a. Revise paragraph (c) of the introductory text. b. Republish section II.(c). c. In section VII, revise the entries for §§ 395.8(a)(2)(ii) and 395.11(b).

    The revisions read as follows:

    Appendix B to Part 385—Explanation of Safety Rating Process

    (c) To meet the safety fitness standard, a motor carrier must demonstrate to the FMCSA that it has adequate safety management controls in place which function effectively to ensure acceptable compliance with the applicable safety requirements. A “safety fitness methodology” (SFRM) was developed by the FMCSA, which uses data from compliance reviews (CRs) and roadside inspections to rate motor carriers.

    II. Converting CR Information Into a Safety Rating

    (c) Critical regulations are those identified as such where noncompliance relates to management and/or operational controls. These are indicative of breakdowns in a carrier's management controls. An example of a critical regulation is § 395.3(a)(1), requiring or permitting a property-carrying commercial motor vehicle driver to drive more than 11 hours.

    VII. List of Acute and Critical Regulations
    § 395.8(a)(2)(ii) Failure to require a driver to submit record of duty status (critical).
    § 395.11(b) Failing to require a driver to submit supporting documents (critical).
    PART 386—RULES OF PRACTICE FOR FMCSA PROCEEDINGS 70. The authority citation for part 386 is revised to read as follows: Authority:

    49 U.S.C. 113; 49 U.S.C. chapters 5, 51, 59, 131-141, 145-149, 311, 313, and 315; Sec. 204, Pub. L. 104-88, 109 Stat. 803, 941 (49 U.S.C. 701 note); Sec. 217, Pub. L. 105-159, 113 Stat. 1748, 1767; Sec. 206, Pub. L. 106-159, 113 Stat. 1763; subtitle B, title IV of Pub. L. 109-59; Sec. 701 of Pub. L. 114-74, 129 Stat. 584, 599; and 49 CFR 1.81 and 1.87.

    71. Amend § 386.1 by revising paragraph (c) to read as follows:
    § 386.1 Scope of rules in this part.

    (c)(1) The rules in § 386.12(a) govern the filing of a complaint of a substantial violation and the handling of the complaint by the appropriate Division Administrator.

    (2) The rules in § 386.12(b) govern the filing by a driver and the handling by the appropriate Division Administrator of a complaint of harassment in violation of § 390.36 of this subchapter.

    (3) The rules in § 386.12(c) govern the filing by a driver and the handling by the appropriate Division Administrator of a complaint of coercion in violation of § 390.6 of this subchapter.

    PART 390—FEDERAL MOTOR CARRIER SAFETY REGULATIONS; GENERAL 72. The authority citation for part 390 is revised to read as follows: Authority:

    49 U.S.C. 504, 508, 31132, 31133, 31134, 31136, 31137, 31144, 31149, 31151, 31502; sec. 114, Pub. L. 103-311, 108 Stat. 1673, 1677-1678; sec. 212, 217, Pub. L. 106-159, 113 Stat. 1748, 1766, 1767; sec. 229, Pub. L. 106-159 (as transferred by sec. 4114 and amended by secs. 4130-4132, Pub. L. 109-59, 119 Stat. 1144, 1726, 1743-1744); sec. 4136, Pub. L. 109-59, 119 Stat. 1144, 1745; sec. 32101(d) and 32934, Pub. L. 112-141, 126 Stat. 405, 778, 830; sec. 2, Pub. L. 113-125, 128 Stat. 1388; sec. 5518, 5524, Pub. L. 114-94, 129 Stat. 1312, 1558, 1560; and 49 CFR 1.81, 1.81a, and 1.87.

    73. Amend § 390.6 by revising paragraph (b)(1) to read as follows:
    § 390.6 Coercion prohibited.

    (b) * * *

    (1) A driver who believes he or she was coerced to violate a regulation described in paragraph (a)(1) or (2) of this section may file a written complaint under § 386.12(c) of this subchapter.

    PART 391—QUALIFICATIONS OF DRIVERS AND LONGER COMBINATION VEHICLE (LCV) DRIVER INSTRUCTORS 74. The authority citation for part 391 continues to read as follows: Authority:

    49 U.S.C. 504, 508, 31133, 31136, 31149, and 31502; sec. 4007(b) of Pub. L. 102-240, 105 Stat. 1914, 2152; sec. 114 of Pub. L. 103-311, 108 Stat. 1673, 1677; sec. 215 of Pub. L. 106-159, 113 Stat. 1748, 1767; sec. 32934 of Pub. L. 112-141, 126 Stat. 405, 830; sec. 5524 of Pub. L. 114-94, 129 Stat. 1312, 1560; and 49 CFR 1.87.

    § 391.42 [Removed]
    75. Remove § 391.42. 76. Amend § 391.43 by revising paragraphs (a), (f), and (h) to read as follows:
    § 391.43 Medical examination; certificate of physical examination.

    (a) Except as provided by paragraph (b) of this section, the medical examination must be performed by a medical examiner listed on the National Registry of Certified Medical Examiners under subpart D of part 390 of this chapter.

    (f) The medical examination shall be performed, and its results shall be recorded on the Medical Examination Report Form, MCSA-5875, set out below:

    BILLING CODE 4910-EX-P ER04OC16.141 ER04OC16.142 ER04OC16.143 ER04OC16.144 ER04OC16.145 ER04OC16.146 ER04OC16.147 ER04OC16.148 ER04OC16.149

    (h) The medical examiner's certificate shall be completed in accordance with the following Form MCSA-5876, Medical Examiner's Certificate:

    ER04OC16.150 BILLING CODE 4910-EX-C
    PART 392—DRIVING OF COMMERCIAL MOTOR VEHICLES 77. The authority citation for part 392 continues to read as follows: Authority:

    49 U.S.C. 504, 13902, 31136, 31151, 31502; Section 112 of Pub. L. 103-311, 108 Stat. 1673, 1676 (1994), as amended by sec. 32509 of Pub. L. 112-141, 126 Stat. 405, 805 (2012); sec. 5524 of Pub. L. 114-94, 129 Stat. 1312, 1560; and 49 CFR 1.87.

    78. Amend § 392.9b by revising paragraph (a) to read as follows:
    § 392.9b Prohibited transportation.

    (a) Safety registration required. A commercial motor vehicle providing transportation in interstate commerce must not be operated without a safety registration and an active USDOT Number.

    PART 395—HOURS OF SERVICE OF DRIVERS 79. The authority citation for part 395 continues to read as follows: Authority:

    49 U.S.C. 504, 31133, 31136, 31137, and 31502; sec. 113, Pub. L. 103-311, 108 Stat. 1673, 1676; sec. 229, Pub. L. 106-159 (as transferred by sec. 4115 and amended by secs. 4130-4132, Pub. L. 109-59, 119 Stat. 1144, 1726, 1743, 1744); sec. 4133, Pub. L. 109-59, 119 Stat. 1144, 1744; sec. 108, Pub. L. 110-432, 122 Stat. 4860-4866; sec. 32934, Pub. L. 112-141, 126 Stat. 405, 830; sec. 5206(b) of Pub. L. 114-94, 129 Stat. 1312, 1537; and 49 CFR 1.87.

    80. Amend § 395.1 by revising the introductory text of paragraph (e)(1) to read as follows:
    § 395.1 Scope of rules in this part.

    (e) Short-haul operations—(1) 100 air-mile radius driver. A driver is exempt from the requirements of §§ 395.8 and 395.11 if:

    81. Amend § 395.8 by revising paragraph (a)(1)(iii)(A)(4) to read as follows:
    § 395.8 Driver's record of duty status.

    (a) * * *

    (1) * * *

    (iii) * * *

    (A) * * *

    (4) That was manufactured before model year 2000, as reflected in the vehicle identification number as shown on the vehicle's registration.

    PART 397—TRANSPORTATION OF HAZARDOUS MATERIALS; DRIVING AND PARKING RULES 82. The authority citation for part 397 continues to read as follows: Authority:

    49 U.S.C. 322; 49 CFR 1.87. Subpart A also issued under 49 U.S.C. 5103, 31136, 31502, and 49 CFR 1.97. Subparts C, D, and E also issued under 49 U.S.C. 5112, 5125.

    83. Amend § 397.73 by revising paragraph (b) to read as follows:
    § 397.73 Public information and reporting requirements.

    (b) Reporting and publishing requirements. (1) Each State or Indian tribe, through its routing agency, shall provide information identifying all NRHM routing designations that exist within its jurisdiction by:

    (i) Electronically, by email to [email protected]; or

    (ii) Mail to the Federal Motor Carrier Safety Administration, Office of Enforcement and Compliance (MC-EC), 1200 New Jersey Ave. SE., Washington, DC 20590-0001.

    (2) States and Indian tribes shall also submit to FMCSA the current name of the State or Indian tribal agency responsible for NHRM highway routing designations. The State or Indian tribe shall include descriptions of these routing designations, along with the dates they were established. Information on any subsequent changes or new NRHM routing designations shall be furnished within 60 days after establishment to the FMCSA. This information will be available from the FMCSA, consolidated by the FMCSA, and published annually in whole or as updates in the Federal Register. Each State or Indian tribe may also publish this information in its official register of State or tribal regulations.

    § 397.101 [Amended]
    84. Amend § 397.101 by removing paragraph (g). 85. Amend § 397.103 by revising paragraph (c)(1) to read as follows:
    § 397.103 Requirements for State routing designations.

    (c) * * *

    (1) The State gives written notice to the Federal Motor Carrier Safety Administration:

    (i) By email to [email protected]; or

    (ii) By certified mail, return receipt requested, to the Federal Motor Carrier Safety Administration, Office of Enforcement and Compliance (MC-EC), 1200 New Jersey Ave., SE., Washington, DC 20590-0001. Attention: National Hazardous Materials Route Registry.

    PART 398—TRANSPORTATION OF MIGRANT WORKERS 86. The authority citation for part 398 continues to read as follows: Authority:

    49 U.S.C. 13301, 13902, 31132, 31133, 31136, 31502, and 31504; sec. 204, Pub. L. 104-88, 109 Stat. 803, 941 (49 U.S.C. 701 note); sec. 212, Pub. L. 106-159, 113 Stat. 1748, 1766; and 49 CFR 1.87.

    87. Amend § 398.1 by revising paragraph (b) to read as follows:
    § 398.1 Definitions.

    (b) Carrier of migrant workers by motor vehicle. “Carrier of migrant worker by motor vehicle” means any person, including any for-hire, non-exempt motor carrier conducting contract carriage operations as defined in 49 U.S.C. 13102(4)(B), but not including any for-hire, non-exempt motor carrier subject to other requirements in 49 U.S.C. subtitle IV, part B besides contract carriage operations, who or which transports in interstate or foreign commerce at any one time three or more migrant workers to or from their employment by any motor vehicle other than a passenger automobile or station wagon, except a migrant worker transporting himself/herself or his/her immediate family.

    Issued under authority delegated in 49 CFR 1.87 on: September 15, 2016. T.F. Scott Darling, III, Administrator.
    [FR Doc. 2016-22996 Filed 9-30-16; 11:15 am] BILLING CODE 4910-EX-P
    DEPARTMENT OF TRANSPORTATION National Highway Traffic Safety Administration 49 CFR Part 593 [Docket No. NHTSA-2016-0081] List of Nonconforming Vehicles Decided To Be Eligible for Importation AGENCY:

    National Highway Traffic Safety Administration (NHTSA), Department of Transportation (DOT).

    ACTION:

    Final rule.

    SUMMARY:

    This document revises the list of vehicles not originally manufactured to conform to the Federal Motor Vehicle Safety Standards (FMVSS) that NHTSA has decided to be eligible for importation. This list is published in an appendix to the agency's regulations that prescribe procedures for import eligibility decisions. The list has been revised to add all vehicles that NHTSA has decided to be eligible for importation since October 1, 2015, and to remove all previously listed vehicles that are now more than 25 years old and need no longer comply with all applicable FMVSS to be lawfully imported. NHTSA is required by statute to publish this list annually in the Federal Register.

    DATES:

    Effective October 4, 2016.

    FOR FURTHER INFORMATION CONTACT:

    George Stevens, Office of Vehicle Safety Compliance, NHTSA, (202) 366-5308.

    SUPPLEMENTARY INFORMATION:

    Under 49 U.S.C. 30141(a)(1)(A), a motor vehicle that was not originally manufactured to conform to all applicable FMVSS shall be refused admission into the United States unless NHTSA has decided that the motor vehicle is substantially similar to a motor vehicle originally manufactured for importation into and sale in the United States, certified under 49 U.S.C. 30115, and of the same model year as the model of the motor vehicle to be compared, and is capable of being readily altered to conform to all applicable FMVSS. Where there is no substantially similar U.S.-certified motor vehicle, 49 U.S.C. 30141(a)(1)(B) permits a nonconforming motor vehicle to be admitted into the United States if its safety features comply with, or are capable of being altered to comply with, all applicable FMVSS based on destructive test data or such other evidence as the Secretary of Transportation decides to be adequate.

    Under 49 U.S.C. 30141(a)(1), import eligibility decisions may be made “on the initiative of the Secretary of Transportation or on petition of a manufacturer or importer registered under [49 U.S.C. 30141(c)].” The Secretary's authority to make these decisions has been delegated to NHTSA. The agency publishes notices of eligibility decisions as they are made.

    Under 49 U.S.C. 30141(b)(2), a list of all vehicles for which import eligibility decisions have been made must be published annually in the Federal Register. On October 1, 1996, NHTSA added the list as an appendix to 49 CFR part 593, the regulations that establish procedures for import eligibility decisions (61 FR 51242). As described in the notice, NHTSA took that action to ensure that the list is more widely disseminated to government personnel who oversee vehicle imports and to interested members of the public. See 61 FR 51242-43. In the notice, NHTSA expressed its intention to annually revise the list as published in the appendix to include any additional vehicles decided by the agency to be eligible for importation since the list was last published. See 61 FR 51243. The agency stated that issuance of the document announcing these revisions will fulfill the annual publication requirements of 49 U.S.C. 30141(b)(2). Ibid.

    Regulatory Analyses and Notices A. Executive Order 12866, Regulatory Planning and Review

    Executive Order 12866, “Regulatory Planning and Review” (58 FR 51735, October 4, 1993), provides for making determinations about whether a regulatory action is “significant” and therefore subject to Office of Management and Budget (OMB) review and to the requirements of the Executive Order. The Executive Order defines a “significant regulatory action” as one that is likely to result in a rule that may:

    (1) Have an annual effect on the economy of $100 million or more or adversely affects in a material way the economy, a sector of the economy, productivity, competition, jobs, the environment, public health or safety, or State, local, or Tribal governments or communities;

    (2) Create a serious inconsistency or otherwise interfere with an action taken or planned by another agency;

    (3) Materially alter the budgetary impact of entitlements, grants, user fees, or loan programs or the rights and obligations of recipients thereof; or

    (4) Raise novel legal or policy issues arising out of legal mandates, the President's priorities, or the principles set forth in the Executive Order. This rule will not have any of these effects and was not reviewed under Executive Order 12866. It is not significant within the meaning of the DOT Regulatory Policies and Procedures. The effect of this rule is not to impose new requirements. Instead it provides a summary compilation of decisions on import eligibility that have already been made and does not involve new decisions. This rule will not impose any additional burden on any person. Accordingly, the agency believes that the preparation of a regulatory evaluation is not warranted for this rule.

    B. Environmental Impacts

    We have not conducted an evaluation of the impacts of this rule under the National Environmental Policy Act. This rule does not impose any change that would result in any impacts to the quality of the human environment. Accordingly, no environmental assessment is required.

    C. Regulatory Flexibility Act

    Pursuant to the Regulatory Flexibility Act, we have considered the impacts of this rule on small entities (5 U.S.C. Sec. 601 et seq.). I certify that this rule will not have a significant economic impact upon a substantial number of small entities within the context of the Regulatory Flexibility Act. The following is our statement providing the factual basis for the certification (5 U.S.C. Sec. 605(b)). This rule will not have any significant economic impact on a substantial number of small businesses because the rule merely furnishes information by revising the list in the Code of Federal Regulations of vehicles for which import eligibility decisions have previously been made. Accordingly, we have not prepared a Final Regulatory Flexibility Analysis.

    D. Executive Order 13132, Federalism

    Executive Order 13132 requires NHTSA to develop an accountable process to ensure “meaningful and timely input by State and local officials in the development of regulatory policies that have federalism implications.” Executive Order 13132 defines the term “Policies that have federalism implications” to include regulations that have “substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government.” Under Executive Order 13132, NHTSA may not issue a regulation that has federalism implications, that imposes substantial direct compliance costs, and that is not required by statute, unless the Federal government provides the funds necessary to pay the direct compliance costs incurred by State and local governments, or NHTSA consults with State and local officials early in the process of developing the regulation.

    This rule will have no direct effect on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government as specified in Executive Order 13132. Thus, the requirements of section 6 of the Executive Order do not apply to this rule.

    E. The Unfunded Mandates Reform Act

    The Unfunded Mandates Reform Act of 1995 (Public Law 104-4) requires agencies to prepare a written assessment of the costs, benefits and other effects of proposed or final rules that include a Federal mandate likely to result in the expenditure by State, local or tribal governments, in the aggregate, or by the private sector, of more than $100 million annually. This rule will not result in additional expenditures by State, local or tribal governments or by any members of the private sector. Therefore, the agency has not prepared an economic assessment pursuant to the Unfunded Mandates Reform Act.

    F. Paperwork Reduction Act

    Under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq.), a person is not required to respond to a collection of information by a Federal agency unless the collection displays a valid OMB control number. This rule does not impose any new collection of information requirements for which a 5 CFR part 1320 clearance must be obtained. DOT previously submitted to OMB and OMB approved the collection of information associated with the vehicle importation program in OMB Clearance No. 2127-0002.

    G. Civil Justice Reform

    Pursuant to Executive Order 12988, “Civil Justice Reform,” we have considered whether this rule has any retroactive effect. We conclude that it will not have such an effect.

    H. Plain Language

    Executive Order 12866 requires each agency to write all rules in plain language. Application of the principles of plain language includes consideration of the following questions:

    —Have we organized the material to suit the public's needs? —Are the requirements in the rule clearly stated? —Does the rule contain technical language or jargon that is not clear? —Would a different format (grouping and order of sections, use of headings, paragraphing) make the rule easier to understand? —Would more (but shorter) sections be better? —Could we improve clarity by adding tables, lists, or diagrams? —What else could we do to make the rule easier to understand? If you wish to do so, please comment on the extent to which this final rule effectively uses plain language principles. I. National Technology Transfer and Advancement Act

    Under the National Technology and Transfer and Advancement Act of 1995 (Public Law 104-113), “all Federal agencies and departments shall use technical standards that are developed or adopted by voluntary consensus standards bodies, using such technical standards as a means to carry out policy objectives or activities determined by the agencies and departments.” This rule does not require the use of any technical standards.

    J. Privacy Act

    Anyone is able to search the electronic form of all comments received into any of our dockets by the name of the individual submitting the comment (or signing the comment, if submitted on behalf of an association, business, labor union, etc.). You may review DOT's complete Privacy Act Statement in the Federal Register published on April 11, 2000 (Volume 65, Number 70; Pages 19477-78).

    K. Executive Order 13045, Economically Significant Rules Disproportionately Affecting Children

    This rule is not subject to Executive Order 13045 because it is not “economically significant” as defined under Executive Order 12866, and does not concern an environmental, health, or safety risk that NHTSA has reason to believe may have a disproportionate effect on children.

    L. Notice and Comment

    NHTSA finds that prior notice and opportunity for comment are unnecessary under 5 U.S.C. 553(b)(3)(B) because this action does not impose any regulatory requirements. This rule merely revises the list of vehicles not originally manufactured to conform to the FMVSS that NHTSA has decided to be eligible for importation into the United States since the last list was published in September, 2015.

    In addition, so that the list of vehicles for which import eligibility decisions have been made may be included in the next edition of 49 CFR parts 572 to 999, which is due for revision on October 1, 2016, good cause exists to dispense with the requirement in 5 U.S.C. 553(d) for the effective date of the rule to be delayed for at least 30 days following its publication.

    List of Subjects in 49 CFR Part 593

    Imports, Motor vehicle safety, Motor vehicles.

    In consideration of the foregoing, part 593 of Title 49 of the Code of Federal Regulations is amended as follows:

    PART 593—[AMENDED] 1. The authority citation for part 593 continues to read as follows: Authority:

    49 U.S.C. 322 and 30141(b); delegation of authority at 49 CFR 1.95.

    2. Appendix A to part 593 is revised to read as follows: Appendix A to Part 593—List of Vehicles Determined To Be Eligible for Importation

    (a) Each vehicle on the following list is followed by a vehicle eligibility number. The importer of a vehicle admissible under any eligibility decision must enter that number on the HS-7 Declaration Form accompanying entry to indicate that the vehicle is eligible for importation.

    (1) “VSA” eligibility numbers are assigned to all vehicles that are decided to be eligible for importation on the initiative of the Administrator under Sec. 593.8.

    (2) “VSP” eligibility numbers are assigned to vehicles that are decided to be eligible under Sec. 593.7(f), based on a petition from a manufacturer or registered importer submitted under Sec. 593.5(a)(1), which establishes that a substantially similar U.S.-certified vehicle exists.

    (3) “VCP” eligibility numbers are assigned to vehicles that are decided to be eligible under Sec. 593.7(f), based on a petition from a manufacturer or registered importer submitted under Sec. 593.5(a)(2), which establishes that the vehicle has safety features that comply with, or are capable of being altered to comply with, all applicable FMVSS.

    (b) Vehicles for which eligibility decisions have been made are listed alphabetically, first by make, then by model, then by model year.

    (c) All hyphens used in the Model Year column mean “through” (for example, “1995-1999” means “1995 through 1999”).

    (d) The initials “MC” used in the Make column mean “Motorcycle.”

    (e) The initials “SWB” used in the Model Type column mean “Short Wheel Base.”

    (f) The initials “LWB” used in the Model Type column mean “Long Wheel Base.”

    (g) For vehicles with a European country of origin, the term “Model Year” ordinarily means calendar year in which the vehicle was produced.

    (h) All vehicles are left-hand-drive (LHD) vehicles unless noted as RHD. The initials “RHD” used in the Model Type column mean “right-hand-drive.”

    (i) For vehicle models that have been determined to be eligible for importation based on a petition submitted under Sec. 593.5(a)(1), which establishes that a substantially similar U.S.-certified vehicle exists, and no specific body style(s) are listed, only the body style(s) of that vehicle model that were U.S.-certified by the original manufacturer are eligible for importation. For example, if the original manufacturer manufactured both sedan and wagon body styles for the described model, but only certified the sedan for the U.S. market, the wagon body style would not be eligible for importation under that determination.

    Vehicles Certified by Their Original Manufacturer as Complying With All Applicable Canadian Motor Vehicle Safety Standards (a) All passenger cars manufactured on or after September 1, 1989, and before September 1, 1996, that, as originally manufactured, are equipped with an automatic restraint system that complies with Federal Motor Vehicle Safety Standard (FMVSS) No. 208; VSA-80 (b) All passenger cars manufactured on or after September 1, 1996, and before September 1, 2002, that, as originally manufactured, are equipped with an automatic restraint system that complies with FMVSS No. 208, and that comply with FMVSS No. 214; (c) All passenger cars manufactured on or after September 1, 2002, and before September 1, 2007, that, as originally manufactured, are equipped with an automatic restraint system that complies with FMVSS No. 208, and that comply with FMVSS Nos. 201, 214, 225, and 401; (d) All passenger cars manufactured on or after September 1, 2007, and before September 1, 2008, that, as originally manufactured, comply with FMVSS Nos. 110, 118, 138, 201, 208, 213, 214, 225, and 401; (e) All passenger cars manufactured on or after September 1, 2008 and before September 1, 2009 that, as originally manufactured, comply with FMVSS Nos. 110, 118, 138, 201, 202a, 206, 208, 213, 214, 225, and 401; (f) All passenger cars manufactured on or after September 1, 2009 and before September 1, 2010 that, as originally manufactured, comply with FMVSS Nos. 118, 138, 201, 202a, 206, 208, 213, 214, 225, and 401; (g) All passenger cars manufactured on or after September 1, 2010 and before September 1, 2011 that, as originally manufactured, comply with FMVSS Nos. 118, 138, 201, 202a, 206, 208, 213, 214, and 225; (h) All passenger cars manufactured on or after September 1, 2011 and before September 1, 2017 that, as originally manufactured, comply with FMVSS Nos. 138, 201, 206, 208, 213, 214, and 225. (a) All multipurpose passenger vehicles, trucks, and buses with a GVWR of 4,536 kg (10,000lb) or less that were manufactured on and after September 1, 1991, and before September 1, 1993 and that, as originally manufactured, comply with FMVSS Nos. 202 and 208; VSA-81 (b) All multipurpose passenger vehicles, trucks, and buses with a GVWR of 4,536 kg (10,000lb) or less that were manufactured on or after September 1, 1993, and before September 1, 1998, and that, as originally manufactured, comply with FMVSS Nos. 202, 208, and 216; (c) All multipurpose passenger vehicles, trucks, and buses with a GVWR of 4,536 kg (10,000lb) or less that were manufactured on or after September 1, 1998, and before September 1, 2002, and that, as originally manufactured, comply with FMVSS Nos. 202, 208, 214, and 216; (d) All multipurpose passenger vehicles, trucks, and buses with a GVWR of 4,536 kg (10,000lb) or less that were manufactured on or after September 1, 2002, and before September 1, 2007, and that, as originally manufactured, comply with FMVSS Nos. 201, 202, 208, 214, and 216, and, insofar as it is applicable, with FMVSS No. 225; (e) All multipurpose passenger vehicles, trucks, and buses with a GVWR of 4,536 kg (10,000lb) or less manufactured on or after September 1, 2007 and before September 1, 2008, that, as originally manufactured, comply with FMVSS Nos. 110, 118, 201, 202, 208, 213, 214, and 216, and insofar as they are applicable, with FMVSS Nos. 138 and 225; (f) All multipurpose passenger vehicles, trucks, and buses with a GVWR of 4,536 kg (10,000lb) or less manufactured on or after September 1, 2008 and before September 1, 2009, that, as originally manufactured, comply with FMVSS Nos. 110, 118, 201, 202a, 206, 208, 213, 214, and 216, and insofar as they are applicable, with FMVSS Nos. 138 and 225; (g) All multipurpose passenger vehicles, trucks, and buses with a GVWR of 4,536 kg (10,000lb) or less manufactured on or after September 1, 2009 and before September 1, 2011, that, as originally manufactured, comply with FMVSS Nos. 118, 201, 202a, 206, 208, 213, 214, and 216, and insofar as they are applicable, with FMVSS Nos. 138 and 225; VSA-81
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  • (h) All multipurpose passenger vehicles, trucks, and buses with a GVWR of 4,536 kg (10,000lb) or less manufactured on or after September 1, 2011 and before September 1, 2012, that, as originally manufactured, comply with FMVSS Nos. 201, 202a, 206, 208, 213, 214, and 216, and insofar as they are applicable, with FMVSS Nos. 138 and 225; (i) All multipurpose passenger vehicles, trucks, and buses with a GVWR of 4,536 kg (10,000lb) or less manufactured on or after September 1, 2012 and before September 1, 2017, that, as originally manufactured, comply with FMVSS Nos. 201, 206, 208, 213, 214, and 216, and insofar as they are applicable, with FMVSS Nos. 138 222, and 225; All multipurpose passenger vehicles, trucks, and buses with a GVWR greater than 4,536 kg (10,000 lb) that are less than 25 years old. VSA-82 All trailers and motorcycles less than 25 years old. VSA-83
    Vehicles Manufactured for Other Than the Canadian Market Make Model type(s) Body/chassis Model years(s) VSP VCP Acura Legend 1991-1992 305 AHLM SPT 16-25 trailer 2012 55 Alfa Romeo 164 1991 76 Alfa Romeo 164 1994 156 Alfa Romeo 8C Spider 2010 61 Alfa Romeo 8C SPIDER 2008-2009 580 Alfa Romeo Spider 1992 503 Alpina B10 Series 1991-1996 54 Alpina B11 Sedan 1991-1994 48 Alpina B12 Coupe 1991-1996 43 Alpina B12 5.0 Sedan 1991-1994 41 Alpina B5 series (manufactured before 9/1/06) 2005-2007 53 Al-Spaw EMA Mobile Stage Trailer 2009 42 Aston Martin Vanquish 2002-2004 430 Aston Martin Vantage 2006-2007 530 Aston Martin Vantage V8 2008 582 Audi 100 1993 244 Audi 100 1991-1992 317 Audi A4 1996-2000 352 Audi A4, RS4, S4 8D 2000-2001 400 Audi A6 1998-1999 332 Audi A8 2000 424 Audi A8 1997-2000 337 Audi A8 Avant Quattro 1996 238 Audi RS6 & RS Avant 2003 443 Audi S6 1996 428 Audi S8 2000 424 Audi TT 2000-2001 364 Bentley Arnage (manufactured 1/1/01-12/31/01) 2001 473 Bentley Azure (LHD & RHD) 1998 485 Bentley Flying Spur 4-door
  • Saloon
  • 2-door Continental
  • 2014 588
    Bimota (MC) DB4 2000 397 Bimota (MC) SB6 1994-1999 523 Bimota (MC) SB8 1999-2000 397 BMW 3 Series 1998 462 BMW 3 Series 1999 379 BMW 3 Series 2000 356 BMW 3 Series 2001 379 BMW 3 Series 1992-1994 550 BMW 3 Series 1995-1997 248 BMW 3 Series 2003-2004 487 BMW 320i 1991 283 BMW 325i 4-door 1991 96 BMW 325i 1992-1996 197 BMW 5 Series 2000 345 BMW 5 Series 1991-1995 194 BMW 5 Series 1995-1997 249 BMW 5 Series 1998-1999 314 BMW 5 Series 2000-2002 414 BMW 5 Series 2003-2004 450 BMW 5 Series (manufactured prior to 9/1/2006) 2005-2007 555 BMW 7 Series 1991 299 BMW 7 Series 1992 232 BMW 7 Series 1993-1994 299 BMW 7 Series 1995-1999 313 BMW 7 Series 1999-2001 366 BMW 760i 2004 559 BMW 8 Series 1991-1995 361 BMW 850 Series 1997 396 BMW M3 Convertible 1991 60 BMW M3 2006-2010 571 BMW M3 (manufactured prior to 9/1/06) 2006 520 BMW X5 (manufactured 1/1/03-12/31/04) 2003-2004 459 BMW Z3 2002 568 BMW Z3 1996-1998 260 BMW Z3 (European market) 1999 483 BMW Z4 2010 553 BMW Z8 2002 406 BMW Z8 2000-2001 350 BMW (MC) C1 2000-2003 40 BMW (MC) K1 1991-1993 228 BMW (MC) K100 1991-1992 285 BMW (MC) K1100, K1200 1993-1998 303 BMW (MC) K1200 GT 2003 556 BMW (MC) K75 1996 36 BMW (MC) K75S 1991-1995 229 BMW (MC) R1100 1994-1997 231 BMW (MC) R1100 1998-2001 368 BMW (MC) R1100 S 2002 557 BMW (MC) R1100RS 1994 177 BMW (MC) R1150GS 2000 453 BMW (MC) R1200C 1998-2001 359 BMW (MC) R80, R100 1991-1995 295 BMW (MC) S1000RR 2011-2012 563 Buell (MC) 1125R, Ulysses XB, Lightning XB, and Blast 2009 579 Buell (MC) All Models 1995-2002 399 Cadillac DeVille 1994-1999 300 Cadillac DeVille (manufactured 8/1/99-12/31/00) 2000 448 Cadillac Escalade 2008 572 Cadillac Seville 1991 375 Cagiva (MC) Gran Canyon 900 1999 444 Carrocerias Cimarron trailer 2006-2007 37 Chevrolet 400SS 1995 150 Chevrolet Astro Van 1997 298 Chevrolet Blazer (plant code of “K” or “2” in the 11th position of the VIN) 1997 349 Chevrolet Blazer (plant code of “K” or “2” in the 11th position of the VIN) 2001 461 Chevrolet Camaro 1999 435 Chevrolet Cavalier 1997 369 Chevrolet Corvette 1992 365 Chevrolet Corvette Coupe 1999 419 Chevrolet Corvette 2007 544 Chevrolet Suburban 2005 541 Chevrolet Suburban 1991-1991 242 Chevrolet Tahoe 2000 504 Chevrolet Tahoe 2001 501 Chevrolet Trailblazer (manufactured prior to 9/1/07 for sale in the Kuwaiti market) 2007 514 Chevy Impala 1996 561 Chrysler Daytona 1992 344 Chrysler Grand Voyager 1998 373 Chrysler LHS (Mexican market) 1996 276 Chrysler Town and Country 1993 273 Citroen XM 1991-1992 1 Dodge Durango 2007 534 Dodge Ram 1994-1995 135 Dodge Ram 1500 Laramie Crew Cab 2009 535 Ducati (MC) 600SS 1992-1996 241 Ducati (MC) 748 1999-2003 421 Ducati (MC) 748 Biposto 1996-1997 220 Ducati (MC) 888 1993 500 Ducati (MC) 900 2001 452 Ducati (MC) 900SS 1991-1996 201 Ducati (MC) 916 1999-2003 421 Ducati (MC) 996 Biposto 1999-2001 475 Ducati (MC) 996R 2001-2002 398 Ducati (MC) MH900E 2001-2002 524 Ducati (MC) Monster 600 2001 407 Ducati (MC) ST4S 1999-2005 474 Ducati (MC) Multistrada 2011 585 E. Lancashine Coachbuilders Limited Double Decker Bus Volvo B7L chassis 2000 59 Eagle Vision 1994 323 Ferrari 348 TB 1992 86 Ferrari 348 TS 1992 161 Ferrari 360 2001 376 Ferrari 360 Spider & Coupe 2003 410 Ferrari 360 (manufactured after 9/31/02) 2002 433 Ferrari 360 (manufactured before 9/1/02) 2002 402 Ferrari 360 Modena 1999-2000 327 Ferrari 360 Series 2004 446 Ferrari 456 1995 256 Ferrari 456 GT & GTA 1999 445 Ferrari 456 GT & GTA 1997-1998 408 Ferrari 512 TR 1993 173 Ferrari 550 2001 377 Ferrari 550 Marinello 1997-1999 292 Ferrari 575 2002-2003 415 Ferrari 575 2004-2005 507 Ferrari 599 (manufactured prior to 9/1/06) 2006 518 Ferrari 599 GTB (Manufactured September 1, 2006 through August 31, 2007) 2006-2007 576 Ferrari 599 2008-2011 587 Ferrari 612 Scagletti (Manufactured before 9/1/06) 2006 573 Ferrari 612 Scaglietti 2005 545 Ferrari California (Manufactured for the European Market) 2010 570 Ferrari Enzo 2003-2004 436 Ferrari F355 1995 259 Ferrari F355 1999 391 Ferrari F355 1996-1998 355 Ferrari F430 (manufactured prior to 9/1/06) 2005-2006 479 Ferrari F50 1995 226 Fisker Karma 2012 577 Ford Bronco (manufactured in Venezuela) 1995-1996 265 Ford Escape (manufactured prior to 9/1/2006) 2007 551 Ford Escort (Nicaraguan market) 1996 322 Ford Escort RS Cosworth 1994-1995 9 Ford Explorer (manufactured in Venezuela) 1991-1998 268 Ford F150 2000 425 Ford F-150 2009 575 Ford F-150 Crew Cab (manufactured for sale in the Mexican market) 2004 548 Ford Mustang 1993 367 Ford Mustang 1997 471 Ford Windstar 1995-1998 250 Freightliner FLD12064ST 1991-1996 179 Freightliner FTLD112064SD 1991-1996 178 Gemala Saranaupaya 1600 Double Axle trailer 2001 58 GMC Suburban 1992-1994 134 Harley-Davidson (MC) FL Series 2010 528 Harley-Davidson (MC) FX, FL, XL & VR Series 2004 422 Harley-Davidson (MC) FX, FL, XL & VR Series 2008 517 Harley-Davidson (MC) FX, FL, XL & VR Series 2009 522 Harley-Davidson (MC) FX, FL, XL & VR Series 2011-2014 567 Harley-Davidson (MC) FX, FL, XL Series 1998 253 Harley-Davidson (MC) FX, FL, XL Series 1999 281 Harley-Davidson (MC) FX, FL, XL Series 2000 321 Harley-Davidson (MC) FX, FL, XL Series 2001 362 Harley-Davidson (MC) FX, FL, XL Series 2002 372 Harley-Davidson (MC) FX, FL, XL Series 2003 393 Harley-Davidson (MC) FX, FL, XL Series 2005 472 Harley-Davidson (MC) FX, FL, XL Series 2006 491 Harley-Davidson (MC) FX, FL, XL Series 1991-1997 202 Harley-Davidson (MC) FX, FL, XL, & VR Series 2007 506 Harley-Davidson (MC) FX, XL & VR Series 2010 578 Harley-Davidson (MC) FXSTC Soft Tail Custom 2007 499 Harley-Davidson (MC) VRSCA 2002 374 Harley-Davidson (MC) VRSCA 2003 394 Harley-Davidson (MC) VRSCA 2004 422 Hatty 45 ft double axle trailer 1999-2000 38 Heku 750 KG boat trailer 2005 33 Hobby Exclusive 650 KMFE Trailer 2002-2003 29 Honda Accord 1991 280 Honda Accord 1992-1999 319 Honda Accord (RHD) Sedan & Wagon 1994-1997 451 Honda CRV 2002 447 Honda CR-V 2005 489 Honda Prelude 1994-1997 309 Honda (MC) CB 750 (CB750F2T) 1996 440 Honda (MC) CBR 250 1991-1994 22 Honda (MC) NT700V (Deauville) 2006-2013 57 Honda (MC) RVF 400 1994-2000 358 Honda (MC) VF750 1994-1998 290 Honda (MC) VFR 400 1994-2000 358 Honda (MC) VFR 400, RVF 400 1991-1993 24 Honda (MC) VFR750 1991-1997 315 Honda (MC) VFR800 1998-1999 315 Honda (MC) VT600 1991-1998 294 Hyundai Elantra 1992-1995 269 Hyundai XG350 2004 494 Ifor Williams LM85G trailer 2005 49 Jaguar Sovereign 1993 78 Jaguar S-Type 2000-2002 411 Jaguar XJ8 2002 536 Jaguar XJS 1991 175 Jaguar XJS 1992 129 Jaguar XJS 1994-1996 195 Jaguar XK-8 1998 330 Jaguar XKR 2005 560 Jeep Cherokee 1993 254 Jeep Cherokee (European market) 1991 211 Jeep Cherokee (LHD & RHD) 1994 493 Jeep Cherokee (LHD & RHD) 1995 180 Jeep Cherokee (LHD & RHD) 1996 493 Jeep Cherokee (RHD) 1997-2001 515 Jeep Cherokee (LHD) 1997-1998 516 Jeep Cherokee (Venezuelan market) 1992 164 Jeep Grand Cherokee 1994 404 Jeep Grand Cherokee 1997 431 Jeep Grand Cherokee 2001 382 Jeep Grand Cherokee (LHD—Japanese market) 1997 389 Jeep Liberty 2002 466 Jeep Liberty 2005 505 Jeep Liberty (Mexican market) 2004 457 Jeep Wrangler 1992 562 Jeep Wrangler 1993 217 Jeep Wrangler 1995 255 Jeep Wrangler 1998 341 Jeep Wrangler (manufactured for sale in the Mexican market) 2003 547 Jeep Wrangler (manufactured for sale in the Mexican market) 2012 584 Jeep Wrangler (RHD) 2000-2003 50 Kawasaki (MC) EL250 1992-1994 233 Kawasaki (MC) Ninja ZX-6R 2002 44 Kawasaki (MC) VN1500-P1/P2 series 2003 492 Kawasaki (MC) ZR750 2000-2003 537 Kawasaki (MC) ZX400 1991-1997 222 Kawasaki (MC) ZX6, ZX7, ZX9, ZX10, ZX11 1991-1999 312 Kawasaki (MC) ZX600 1991-1998 288 Kawasaki (MC) ZZR1100 1993-1998 247 Ken-Mex T800 1991-1996 187 Kenworth T800 1992 115 Komet Standard, Classic & Eurolite trailer 2000-2005 477 KTM (MC) Duke II 1995-2000 363 Lamborghini Diablo SE30 1994-1995 586 Lamborghini Diablo Coupe 1997 26 Lamborghini Diablo (except 1997 Coupe) 1996-1997 416 Lamborghini Gallardo (manufactured 1/1/04-12/31/04) 2004 458 Lamborghini Gallardo (manufactured 1/1/06-8/31/06) 2006 508 Lamborghini Murcielago Roadster 2005 476 Land Rover Defender 110 1993 212 Land Rover Defender 90 VIN & Body Limited 1994-1995 512 Land Rover Defender 90 (manufactured before 9/1/97) and VIN “SALDV224*VA” or “SALDV324*VA” 1997 432 Land Rover Discovery 1994-1998 338 Land Rover Discovery (II) 2000 437 Land Rover Range Rover 2004 509 Land Rover Range Rover 2006 538 Lexus GS300 1998 460 Lexus GS300 1993-1996 293 Lexus RX300 1998-1999 307 Lexus SC300 1991-1996 225 Lexus SC400 1991-1996 225 Lincoln Mark VII 1992 144 M&V Type NS4G31 trailer 2008-2010 46 Magni (MC) Australia, Sfida 1996-1999 264 Mazda MPV 2000 413 Mazda MX-5 Miata 1991-1993 184 Mazda RX-7 1991-1995 279 Mazda Xedos 9 1995-2000 351 McLaren MP4-12C 2012 569 Mercedes-Benz 190 E 201.024 1991 45 Mercedes-Benz 190 E 201.028 1992 71 Mercedes-Benz 190 E 201.018 1992 126 Mercedes-Benz 190 E 1993 454 Mercedes-Benz 200 E 124.012 1991 109 Mercedes-Benz 200 E 124.019 1993 75 Mercedes-Benz 220 E 1993 168 Mercedes-Benz 220 TE Station Wagon 1993-1996 167 Mercedes-Benz 230 CE 124.043 1991 84 Mercedes-Benz 230 CE 123.043 1992 203 Mercedes-Benz 230 E 124.023 1991 74 Mercedes-Benz 230 E 124.023 1993 127 Mercedes-Benz 250 D 1992 172 Mercedes-Benz 250 E 1991-1993 245 Mercedes-Benz 260 E 124.026 1992 105 Mercedes-Benz 280 E 1993 166 Mercedes-Benz 300 CE 124.051 1991 83 Mercedes-Benz 300 CE 124.050 1992 117 Mercedes-Benz 300 CE 124.061 1993 94 Mercedes-Benz 300 E 124.031 1992 114 Mercedes-Benz 300 E 4-Matic 1991-1993 192 Mercedes-Benz 300 SL 129.006 1992 54 Mercedes-Benz 300 TE 1992 193 Mercedes-Benz 320 CE 1993 310 Mercedes-Benz 320 SL 1992-1993 142 Mercedes-Benz 350 CLS 2004 45 Mercedes-Benz 400 SE 1992-1994 296 Mercedes-Benz 420 E 1993 169 Mercedes-Benz 420 SE 1991 230 Mercedes-Benz 500 E 124.036 1991 56 Mercedes-Benz 500 SE 140.050 1991 26 Mercedes-Benz 500 SEL 126.037 1991 63 Mercedes-Benz 500 SL 126.066 1991 33 Mercedes-Benz 500 SL 129.006 1992 60 Mercedes-Benz 560 SEC 1991 333 Mercedes-Benz 560 SEL 140 1991 469 Mercedes-Benz 600 SEC Coupe 1993 185 Mercedes-Benz 600 SEL 140.057 1993-1998 271 Mercedes-Benz 600 SL 129.076 1992 121 Mercedes-Benz C 320 203 2001-2002 441 Mercedes-Benz C Class 1994-1999 331 Mercedes-Benz C Class 203 2000-2001 456 Mercedes-Benz C Class (manufactured prior to 9/1/2006) W203 2003-2006 521 Mercedes-Benz CL 500 1998 277 Mercedes-Benz CL 500 1999-2001 370 Mercedes-Benz CL 600 1999-2001 370 Mercedes-Benz CLK 320 1998 357 Mercedes-Benz CLK Class 1999-2001 380 Mercedes-Benz CLK Class 209 2002-2005 478 Mercedes-Benz CLS Class (manufactured prior to 9/1/06) 2006 532 Mercedes-Benz E 200 1994 207 Mercedes-Benz E 200 1995-1998 278 Mercedes-Benz E 220 1994-1996 168 Mercedes-Benz E 250 1994-1995 245 Mercedes-Benz E 280 1994-1996 166 Mercedes-Benz E 320 1994-1998 240 Mercedes-Benz E 320 Station Wagon 1994-1999 318 Mercedes-Benz E 320 211 2002-2003 418 Mercedes-Benz E 420 1994-1996 169 Mercedes-Benz E 500 1994 163 Mercedes-Benz E 500 1995-1997 304 Mercedes-Benz E Class W210 1996-2002 401 Mercedes-Benz E Class 211 2003-2004 429 Mercedes-Benz E Series 1991-1995 354 Mercedes-Benz G Class 463 Chassis 1991 51 Mercedes-Benz G Class 463 Chassis, LWB 2005 549 Mercedes-Benz G Class 463 Chassis, LWB 2009 583 Mercedes-Benz G Class LWB 463 Chassis 2006-2007 527 Mercedes-Benz G-Wagon 463 1996 11 Mercedes-Benz G-Wagon 463 1997 15 Mercedes-Benz G-Wagon 463 1998 16 Mercedes-Benz G-Wagon 463 1999-2000 18 Mercedes-Benz G-Wagon 300 GE LWB 463.228 1993 3 Mercedes-Benz G-Wagon 300 GE LWB 463.228 1994 5 Mercedes-Benz G-Wagon 300 GE LWB 463.228 1991-1992 5 Mercedes-Benz G-Wagon 320 LWB 463 1995 6 Mercedes-Benz G-Wagon 5 DR LWB 463 2001 21 Mercedes-Benz G-Wagon LWB 463 5 DR 2002 392 Mercedes-Benz G-Wagon LWB V-8 463 1992-1996 13 Mercedes-Benz G-Wagon SWB 463 Cabriolet & 3DR 2004 28 Mercedes-Benz G-Wagon SWB 463 2005 31 Mercedes-Benz G-Wagon SWB 463 1991-1996 14 Mercedes-Benz G-Wagon SWB 463 Cabriolet & 3DR 2001-2003 25 Mercedes-Benz G-Wagon SWB
  • (manufactured before 9/1/06)
  • 463 Cabriolet & 3DR 2006 35
    Mercedes-Benz Maybach 2004 486 Mercedes-Benz S 280 140.028 1994 85 Mercedes-Benz S 320 1994-1998 236 Mercedes-Benz S 420 1994-1997 267 Mercedes-Benz S 500 1994-1997 235 Mercedes-Benz S 500 2000-2001 371 Mercedes-Benz S 600 Coupe 1994 185 Mercedes-Benz S 600 1995-1999 297 Mercedes-Benz S 600 2000-2001 371 Mercedes-Benz S 600L 1994 214 Mercedes-Benz S Class 1993 395 Mercedes-Benz S Class 2012 565 Mercedes-Benz S Class 140 1991-1994 423 Mercedes-Benz S Class 1995-1998 342 Mercedes-Benz S Class 1998-1999 325 Mercedes-Benz S Class W220 1999-2002 387 Mercedes-Benz S Class 220 2002-2004 442 Mercedes-Benz S Class 2007-2010 566 Mercedes-Benz S Class (manufactured prior to 9/1/2006) 2005-2006 525 Mercedes-Benz SE Class 1992-1994 343 Mercedes-Benz SEL Class 140 1992-1994 343 Mercedes-Benz SL (Manufactured before 9/1/06) 2006 574 Mercedes-Benz SL Class 1993-1996 329 Mercedes-Benz SL Class W129 1997-2000 386 Mercedes-Benz SL Class R230 2001-2002 19 Mercedes-Benz SL Class (European market) 230 2003-2005 470 Mercedes-Benz SLK 1997-1998 257 Mercedes-Benz SLK 2000-2001 381 Mercedes-Benz SLK Class 2014 581 Mercedes-Benz SLK Class (manufactured between 8/31/04 and 8/31/06) 171 Chassis 2005-2006 511 Mercedes-Benz SLR (manufactured prior to 9/1/2006) 2005-2006 558 Mercedes-Benz (truck) Sprinter 2001-2005 468 Mini Cooper (European market) Convertible 2005 482 Mitsubishi Outlander 2011 564 Moto Guzzi (MC) California 2000-2001 495 Moto Guzzi (MC) California EV 2002 403 Moto Guzzi (MC) Daytona 1993 118 Moto Guzzi (MC) Daytona RS 1996-1999 264 MV Agusta (MC) F4 2000 420 Nissan GTS & GTR (RHD), a.k.a. “Skyline,” manufactured 1/96-6/98 R33 1996-1998 32 Nissan Pathfinder 2002 412 Nissan Pathfinder 1991-1995 316 Plymouth Voyager 1996 353 Pontiac Firebird Trans Am 1995 481 Pontiac Trans Sport MPV 1993 189 Porsche 911 1991 526 Porsche 911 997 2009 542 Porsche 911 1997-2000 346 Porsche 911 (996) Carrera 2002-2004 439 Porsche 911 (996) GT3 2004 438 Porsche 911 Carrera 1993 165 Porsche 911 Carrera 1994 103 Porsche 911 Carrera 1995-1996 165 Porsche 911 Carrera (manufactured prior to 9/1/06) Cabriolet 2005-2006 513 Porsche 911 Carrera (manufactured prior to 9/1/06) 2005-2006 531 Porsche 911 Carrera 2 & Carrera 4 1992 52 Porsche 911 Turbo 1992 125 Porsche 911 Turbo 2001 347 Porsche 928 1991-1996 266 Porsche 928 1993-1998 272 Porsche 946 Turbo 1994 116 Porsche Boxster 1997-2001 390 Porsche Boxster (manufactured before 9/1/02) 2002 390 Porsche Carrera GT 2004-2005 463 Porsche Carrera Series 964 1992 546 Porsche Cayenne 2003-2004 464 Porsche Cayenne (manufactured prior to 9/1/06) 2006 519 Porsche Cayenne S 2009 543 Porsche GT2 2001 20 Porsche GT2 2002 388 Porsche GT3 RS 2012 552 Rice Beaufort Double 1991 529 Rolls Royce Bentley Brooklands 1993 186 Rolls Royce Bentley Continental R 1991-1993 258 Rolls Royce Bentley Turbo R 1995 243 Rolls Royce Bentley Turbo R 1992-1993 291 Rolls Royce Phantom 2004 455 Saab 9.3 2003 426 Saab 900 SE 1995 213 Saab 900 SE 1991-1994 219 Saab 900 SE 1996-1997 219 Saab 9000 1994 334 Smart Car Fortwo coupe & cabriolet (incl. trim levels passion, pulse, & pure) 2005 30 Smart Car Fortwo coupe & cabriolet (incl. trim levels passion, pulse, & pure) 2002-2004 27 Smart Car Fortwo coupe & cabriolet (incl. trim levels passion, pulse, & pure) manufactured before 9/1/06 2006 34 Smart Car Fortwo coupe & cabriolet (incl. trim levels passion, pulse, & pure) manufactured before 9/1/06 2007 39 Subaru Forester 2006-2007 510 Suzuki (MC) GSF 750 1996-1998 287 Suzuki (MC) GSX1300R, a.k.a. “Hayabusa” 1999-2006 484 Suzuki (MC) GSX1300R, a.k.a. “Hayabusa” 2007-2011 533 Suzuki (MC) GSX-R 1100 1991-1997 227 Suzuki (MC) GSX-R 750 1991-1998 275 Suzuki (MC) GSX-R 750 1999-2003 417 Thule 3008BL boat trailer 2011 52 Toyota 4-Runner 1998 449 Toyota Avalon 1995-1998 308 Toyota Land Cruiser 1991-1996 218 Toyota Land Cruiser (manufactured prior to 9/1/2006) IFS 100 series 1999-2006 539 Toyota MR2 1991 324 Toyota Previa 1991-1992 326 Toyota Previa 1993-1997 302 Toyota RAV4 1996 328 Toyota RAV4 2005 480 Triumph (MC) Thunderbird 1995-1999 311 Vespa (MC) ET2, ET4 2001-2002 378 Vespa (MC) LX and PX 2004-2005 496 Volkswagen Bora 1999 540 Volkswagen Eurovan 1993-1994 306 Volkswagen Golf 2005 502 Volkswagen Golf III 1993 92 Volkswagen GTI (Canadian market) 1991 149 Volkswagen Jetta 1994-1996 274 Volkswagen Passat 4-door Sedan 1992 148 Volkswagen Passat Wagon & Sedan 2004 488 Volkswagen Transporter 1991 554 Volvo 740 GL 1992 137 Volvo 850 Turbo 1995-1998 286 Volvo 940 GL 1992 137 Volvo 940 GL 1993 95 Volvo 945 GL Wagon 1994 132 Volvo 960 Sedan & Wagon 1994 176 Volvo C70 2000 434 Volvo S70 1998-2000 335 Westfalia 14ft Double Axle Cargo trailer 1994&1997 56 Yamaha (MC) Drag Star 1100 1999-2007 497 Yamaha (MC) FJ1200 (4 CR) 1991 113 Yamaha (MC) FJR 1300 2002 23 Yamaha (MC) R1 2000 360 Yamaha (MC) Virago 1991-1998 301
    Authority:

    49 U.S.C. 30141(b); 49 CFR 593.9; delegations of authority at 49 CFR 1.95 and 501.8.

    Issued on: September 27, 2016. Mark R. Rosekind, Administrator.
    [FR Doc. 2016-23941 Filed 10-3-16; 8:45 am] BILLING CODE 4910-59-P
    DEPARTMENT OF COMMERCE National Oceanic and Atmospheric Administration 50 CFR Part 679 [Docket No. 150916863-6211-02] RIN 0648-XE925 Fisheries of the Exclusive Economic Zone Off Alaska; Several Groundfish Species in the Bering Sea and Aleutian Islands Management Area AGENCY:

    National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.

    ACTION:

    Temporary rule; apportionment of reserves; request for comments.

    SUMMARY:

    NMFS apportions amounts of the non-specified reserve to the initial total allowable catch (ITAC) of Bering Sea (BS) Pacific ocean perch, Bering Sea and Aleutian Islands (BSAI) Kamchatka flounder, BSAI “other flatfish,” BSAI northern rockfish, BSAI skates, BSAI sculpins, and BSAI squids in the BSAI management area. This action is necessary to allow the fisheries to continue operating. It is intended to promote the goals and objectives of the fishery management plan for the BSAI management area.

    DATES:

    Effective September 29, 2016 through 2400 hrs, Alaska local time, December 31, 2016. Comments must be received at the following address no later than 4:30 p.m., Alaska local time, October 19, 2016.

    ADDRESSES:

    You may submit comments on this document, identified by NOAA-NMFS-2015-0118, by any of the following methods:

    Electronic Submission: Submit all electronic public comments via the Federal e-Rulemaking Portal. Go to, http://www.regulations.gov/docket?D=NOAA-NMFS-2015-0118, click the “Comment Now!” icon, complete the required fields, and enter or attach your comments.

    Mail: Submit written comments to Glenn Merrill, Assistant Regional Administrator, Sustainable Fisheries Division, Alaska Region NMFS, Attn: Ellen Sebastian. Mail comments to P.O. Box 21668, Juneau, AK 99802-1668.

    Instructions: Comments sent by any other method, to any other address or individual, or received after the end of the comment period, may not be considered by NMFS. All comments received are a part of the public record and will generally be posted for public viewing on www.regulations.gov without change. All personal identifying information (e.g., name, address, etc.), confidential business information, or otherwise sensitive information submitted voluntarily by the sender will be publicly accessible. NMFS will accept anonymous comments (enter “N/A” in the required fields if you wish to remain anonymous).
    FOR FURTHER INFORMATION CONTACT:

    Steve Whitney, 907-586-7228.

    SUPPLEMENTARY INFORMATION:

    NMFS manages the groundfish fishery in the (BSAI) exclusive economic zone according to the Fishery Management Plan for Groundfish of the Bering Sea and Aleutian Islands Management Area (FMP) prepared by the North Pacific Fishery Management Council under authority of the Magnuson-Stevens Fishery Conservation and Management Act. Regulations governing fishing by U.S. vessels in accordance with the FMP appear at subpart H of 50 CFR part 600 and 50 CFR part 679.

    The 2016 ITAC of BS Pacific ocean perch was established as 6,800 metric tons (mt), the 2016 ITAC of BSAI Kamchatka flounder was established as 4,250 mt, the 2016 ITAC of BSAI “other flatfish” was established as 2,125 mt, the 2016 ITAC of BSAI northern rockfish was established as 3,825 mt, the 2016 ITAC of BSAI skates was established as 22,100 mt, the 2016 ITAC of BSAI sculpins was established as 3,825 mt, and the 2016 ITAC of BSAI squids was established as 1,275 mt by the final 2016 and 2017 harvest specifications for groundfish of the BSAI (81 FR 14773, March 18, 2016). In accordance with § 679.20(a)(3) the Regional Administrator, Alaska Region, NMFS, has reviewed the most current available data and finds that the ITACs for BS Pacific ocean perch, BSAI Kamchatka flounder, BSAI “other flatfish,” BSAI northern rockfish, BSAI skates BSAI sculpins, and BSAI squids need to be supplemented from the non-specified reserve to promote efficiency in the utilization of fishery resources in the BSAI and allow fishing operations to continue.

    Therefore, in accordance with § 679.20(b)(3), NMFS apportions from the non-specified reserve of groundfish 1,400 mt to the BS Pacific ocean perch ITAC, 300 mt to the BSAI Kamchatka flounder ITAC, 737 mt to the BSAI “other flatfish” ITAC, 550 mt to the BSAI northern rockfish ITAC, 5,000 mt to the BSAI skates ITAC, 500 mt to the BSAI sculpins ITAC, and 30 mt to the BSAI squids ITAC. These apportionments are consistent with § 679.20(b)(1)(i) and do not result in overfishing of any target species because the revised ITACs and total allowable catch (TAC) are equal to or less than the specifications of the acceptable biological catch in the final 2016 and 2017 harvest specifications for groundfish in the BSAI (81 FR 14773, March 18, 2016).

    The harvest specification for the 2016 ITACs and TACs included in the harvest specifications for groundfish in the BSAI are revised as follows: The 2016 ITAC is increased to 4,550 mt for BSAI Kamchatka flounder, 2,862 mt for BSAI “other flatfish,” 4,375 mt for BSAI northern rockfish, 27,100 mt for BSAI skates, 4,325 mt for BSAI sculpins, and 1,305 mt for BSAI squids. The ITAC is increased to the full TAC of 8,200 mt for BS Pacific ocean perch.

    Classification

    This action responds to the best available information recently obtained from the fishery. The Assistant Administrator for Fisheries, NOAA, (AA) finds good cause to waive the requirement to provide prior notice and opportunity for public comment pursuant to the authority set forth at 5 U.S.C. 553(b)(B) and § 679.20(b)(3)(iii)(A) as such a requirement is impracticable and contrary to the public interest. This requirement is impracticable and contrary to the public interest as it would prevent NMFS from responding to the most recent fisheries data in a timely fashion and would delay the apportionment of the non-specified reserves of groundfish to the BS Pacific ocean perch, BSAI Kamchatka flounder, BSAI “other flatfish,” BSAI northern rockfish, BSAI skates, BSAI sculpins, and BSAI squids in the BSAI. Immediate notification is necessary to allow for the orderly conduct and efficient operation of this fishery, to allow the industry to plan for the fishing season, and to avoid potential disruption to the fishing fleet and processors. NMFS was unable to publish a notice providing time for public comment because the most recent, relevant data only became available as of September 26, 2016.

    The AA also finds good cause to waive the 30-day delay in the effective date of this action under 5 U.S.C. 553(d)(3). This finding is based upon the reasons provided above for waiver of prior notice and opportunity for public comment.

    Under § 679.20(b)(3)(iii), interested persons are invited to submit written comments on this action (see ADDRESSES) until October 19, 2016.

    This action is required by § 679.20 and is exempt from review under Executive Order 12866.

    Authority:

    16 U.S.C. 1801, et seq.

    Dated: September 29, 2016. Emily H. Menashes, Acting Director, Office of Sustainable Fisheries, National Marine Fisheries Service.
    [FR Doc. 2016-23969 Filed 9-29-16; 4:15 pm] BILLING CODE 3510-22-P
    81 192 Tuesday, October 4, 2016 Proposed Rules DEPARTMENT OF TRANSPORTATION Federal Aviation Administration 14 CFR Part 39 [Docket No. FAA-2016-9185; Directorate Identifier 2016-NM-077-AD] RIN 2120-AA64 Airworthiness Directives; The Boeing Company Airplanes AGENCY:

    Federal Aviation Administration (FAA), DOT.

    ACTION:

    Notice of proposed rulemaking (NPRM).

    SUMMARY:

    We propose to adopt a new airworthiness directive (AD) for all The Boeing Company Model 757-200, -200PF, and -200CB series airplanes. This proposed AD was prompted by an analysis of the cam support assemblies of the main cargo door which indicated that the existing maintenance program for the cam support assemblies is not adequate to reliably detect cracks before two adjacent cam support assemblies could fail. This proposed AD would require an inspection to determine part numbers, repetitive inspections to detect cracking of affected cam support assemblies of the main cargo door, and replacement if necessary. We are proposing this AD to detect and correct cracking of the cam support assemblies of the main cargo door, which could result in reduced structural integrity of the main cargo door and consequent rapid decompression of the airplane.

    DATES:

    We must receive comments on this proposed AD by November 18, 2016.

    ADDRESSES:

    You may send comments, using the procedures found in 14 CFR 11.43 and 11.45, by any of the following methods:

    Federal eRulemaking Portal: Go to http://www.regulations.gov. Follow the instructions for submitting comments.

    Fax: 202-493-2251.

    Mail: U.S. Department of Transportation, Docket Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New Jersey Avenue SE., Washington, DC 20590.

    Hand Delivery: Deliver to Mail address above between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays.

    For service information identified in this NPRM, contact Boeing Commercial Airplanes, Attention: Data & Services Management, P.O. Box 3707, MC 2H-65, Seattle, WA 98124-2207; telephone: 206-544-5000, extension 1; fax: 206-766-5680; Internet: https://www.myboeingfleet.com. You may view this referenced service information at the FAA, Transport Airplane Directorate, 1601 Lind Avenue SW., Renton, WA. For information on the availability of this material at the FAA, call 425-227-1221. It is also available on the internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2016-9185.

    Examining the AD Docket

    You may examine the AD docket on the Internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2016-9185; or in person at the Docket Management Facility between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays. The AD docket contains this proposed AD, the regulatory evaluation, any comments received, and other information. The street address for the Docket Office (phone: 800-647-5527) is in the ADDRESSES section. Comments will be available in the AD docket shortly after receipt.

    FOR FURTHER INFORMATION CONTACT:

    Chandra Ramdoss, Aerospace Engineer, Airframe Branch, ANM-120L, FAA, Los Angeles Aircraft Certification Office (ACO), 3960 Paramount Boulevard, Lakewood, CA 90712-4137; phone: 562-627-5239; fax: 562-627-5210; email: [email protected]

    SUPPLEMENTARY INFORMATION: Comments Invited

    We invite you to send any written relevant data, views, or arguments about this proposal. Send your comments to an address listed under the ADDRESSES section. Include “Docket No. FAA-2016-9185; Directorate Identifier 2016-NM-077-AD” at the beginning of your comments. We specifically invite comments on the overall regulatory, economic, environmental, and energy aspects of this proposed AD. We will consider all comments received by the closing date and may amend this proposed AD because of those comments.

    We will post all comments we receive, without change, to http://www.regulations.gov, including any personal information you provide. We will also post a report summarizing each substantive verbal contact we receive about this proposed AD.

    Discussion

    We have received an analysis of the cam support assemblies of the main cargo door which indicated that the existing maintenance program for the cam support assemblies is not adequate to reliably detect cracks before two adjacent cam support assemblies could fail on certain Boeing Model 757-200, -200PF, and -200CB series airplanes.

    The main cargo door is on the upper left side of the forward fuselage between body stations 480 and 620. The door is hinged on its upper edge and opens outward to a canopy or a fully open position. The main cargo door has eight cam support assemblies along the bottom of the door that support the latch cams. The door latch cams engage with latch pins on the fuselage and hold the door closed. The cam support assemblies of the main cargo door are subject to ground loads, flight loads, and cabin pressure loads.

    Cracking of the cam support assemblies of the main cargo door could result in reduced structural integrity of the main cargo door and consequent rapid decompression of the airplane.

    Related Service Information Under 1 CFR Part 51

    We reviewed Boeing Alert Service Bulletin 757-52A0094, dated December 23, 2015. The service information describes procedures for doing an ultrasonic inspection of the cam support assemblies of the main cargo door, and replacement of the cam support assemblies. This service information is reasonably available because the interested parties have access to it through their normal course of business or by the means identified in the ADDRESSES section.

    FAA's Determination

    We are proposing this AD because we evaluated all the relevant information and determined the unsafe condition described previously is likely to exist or develop in other products of the same type design.

    Proposed AD Requirements

    This proposed AD would require accomplishing the actions specified in the service information described previously, except as discussed under “Differences Between this Proposed AD and the Service Information.” For information on the procedures and compliance times, see this service information at http://www.regulations.gov by searching for and locating Docket No. FAA-2016-9185.

    Differences Between This Proposed AD and the Service Information

    The effectivity of Boeing Alert Service Bulletin 757-52A0094, dated December 23, 2015, is limited to certain Model 757-200, -200PF, and -200CB series airplanes. However, the applicability of this proposed AD includes all Model 757-200, -200PF, and -200CB series airplanes because all airplanes must be inspected to determine if affected cam support assemblies of the main cargo door are installed. For all airplanes affected by this AD, including those airplanes not listed in the effectivity of Boeing Alert Service Bulletin 757-52A0094, dated December 23, 2015, compliance with paragraph (h) of this AD must be done using Boeing Alert Service Bulletin 757-52A0094, dated December 23, 2015. Therefore, an alternative method of compliance (AMOC) approval is not necessary for those airplanes if Boeing Alert Service Bulletin 757-52A0094, dated December 23, 2015, is used. This difference has been coordinated with Boeing.

    Costs of Compliance

    We estimate that this proposed AD affects 212 airplanes of U.S. registry.

    We estimate the following costs to comply with this proposed AD:

    Estimated Costs Action Labor cost Parts cost Cost per product Cost on U.S. operators Inspection 6 work-hours × $85 per hour = $510 per inspection cycle $0 $510 per inspection cycle $108,120 per inspection cycle.

    We estimate the following costs to do any necessary replacements that would be required based on the results of the proposed inspection. We have no way of determining the number of aircraft that might need these replacements:

    On-Condition Costs Action Labor cost Parts cost Cost per
  • product
  • Replacement (per pair of cam support assemblies) 60 work-hours × $85 per hour = $5,100 $15,298 $20,398
    Authority for This Rulemaking

    Title 49 of the United States Code specifies the FAA's authority to issue rules on aviation safety. Subtitle I, section 106, describes the authority of the FAA Administrator. Subtitle VII: Aviation Programs, describes in more detail the scope of the Agency's authority.

    We are issuing this rulemaking under the authority described in Subtitle VII, Part A, Subpart III, Section 44701: “General requirements.” Under that section, Congress charges the FAA with promoting safe flight of civil aircraft in air commerce by prescribing regulations for practices, methods, and procedures the Administrator finds necessary for safety in air commerce. This regulation is within the scope of that authority because it addresses an unsafe condition that is likely to exist or develop on products identified in this rulemaking action.

    Regulatory Findings

    We determined that this proposed AD would not have federalism implications under Executive Order 13132. This proposed AD would not have a substantial direct effect on the States, on the relationship between the national Government and the States, or on the distribution of power and responsibilities among the various levels of government.

    For the reasons discussed above, I certify this proposed regulation:

    (1) Is not a “significant regulatory action” under Executive Order 12866,

    (2) Is not a “significant rule” under the DOT Regulatory Policies and Procedures (44 FR 11034, February 26, 1979),

    (3) Will not affect intrastate aviation in Alaska, and

    (4) Will not have a significant economic impact, positive or negative, on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.

    List of Subjects in 14 CFR Part 39

    Air transportation, Aircraft, Aviation safety, Incorporation by reference, Safety.

    The Proposed Amendment

    Accordingly, under the authority delegated to me by the Administrator, the FAA proposes to amend 14 CFR part 39 as follows:

    PART 39—AIRWORTHINESS DIRECTIVES 1. The authority citation for part 39 continues to read as follows: Authority:

    49 U.S.C. 106(g), 40113, 44701.

    § 39.13 [Amended]
    2. The FAA amends § 39.13 by adding the following new airworthiness directive (AD):

    The Boeing Company: Docket No. FAA-2016-9185; Directorate Identifier 2016-NM-077-AD.

    (a) Comments Due Date

    We must receive comments by November 18, 2016.

    (b) Affected ADs

    None.

    (c) Applicability

    This AD applies to all The Boeing Company Model 757-200, -200PF, and -200CB series airplanes, certificated in any category.

    (d) Subject

    Air Transport Association (ATA) of America Code 52, Doors.

    (e) Unsafe Condition

    This AD was prompted by an analysis of the cam support assemblies of the main cargo door which indicated that the existing maintenance program for the cam support assemblies is not adequate to reliably detect cracks before two adjacent cam support assemblies could fail. We are issuing this AD to detect and correct cracking of the cam support assemblies of the main cargo door, which could result in reduced structural integrity of the main cargo door and consequent rapid decompression of the airplane.

    (f) Compliance

    Comply with this AD within the compliance times specified, unless already done.

    (g) Inspection To Determine Part Numbers

    At the later of the times specified in paragraphs (g)(1) and (g)(2) of this AD: Inspect the cam support assemblies of the main cargo door to determine whether part number (P/N) 69-23588-5, 69-23588-6, 69-23588-7, 69-23588-8, 69-23588-9, or 69-23588-10 is installed. A review of airplane maintenance records is acceptable in lieu of this inspection if the part number(s) of the cam support assemblies of the main cargo door can be conclusively determined from that review.

    (1) Before the accumulation of 18,000 total flight cycles.

    (2) Within 2,743 flight cycles or 27 months after the effective date of this AD, whichever occurs later.

    (h) Inspections and Corrective Actions

    If, during any inspection required by paragraph (g) of this AD, any cam support assembly of the main cargo door having P/N 69-23588-5, 69-23588-6, 69-23588-7, 69-23588-8, 69-23588-9, or 69-23588-10 is determined to be installed: At the later of the times specified in paragraphs (g)(1) and (g)(2) of this AD, do an ultrasonic inspection to detect cracking of the affected cam support assemblies of the main cargo door; and do all applicable replacements; in accordance with the Accomplishment Instructions of Boeing Alert Service Bulletin 757-52A0094, dated December 23, 2015. Do all applicable replacements before further flight. Repeat the inspections thereafter at intervals not to exceed 6,000 flight cycles. Replacement of a cam support assembly of the main cargo door does not terminate the repetitive inspections required by this paragraph.

    (i) Alternative Methods of Compliance (AMOCs)

    (1) The Manager, Los Angeles Aircraft Certification Office (ACO), FAA, has the authority to approve AMOCs for this AD, if requested using the procedures found in 14 CFR 39.19. In accordance with 14 CFR 39.19, send your request to your principal inspector or local Flight Standards District Office, as appropriate. If sending information directly to the manager of the ACO, send it to the attention of the person identified in paragraph (j)(1) of this AD. Information may be emailed to: [email protected]

    (2) Before using any approved AMOC, notify your appropriate principal inspector, or lacking a principal inspector, the manager of the local flight standards district office/certificate holding district office.

    (3) An AMOC that provides an acceptable level of safety may be used for any repair, modification, or alteration required by this AD if it is approved by the Boeing Commercial Airplanes Organization Designation Authorization (ODA) that has been authorized by the Manager, Los Angeles ACO, to make those findings. To be approved, the repair method, modification deviation, or alteration deviation must meet the certification basis of the airplane, and the approval must specifically refer to this AD.

    (4) For service information that contains steps that are labeled as Required for Compliance (RC), the provisions of paragraphs (i)(4)(i) and (i)(4)(ii) of this AD apply.

    (i) The steps labeled as RC, including substeps under an RC step and any figures identified in an RC step, must be done to comply with the AD. If a step or sub-step is labeled “RC Exempt,” then the RC requirement is removed from that step or sub-step. An AMOC is required for any deviations to RC steps, including substeps and identified figures.

    (ii) Steps not labeled as RC may be deviated from using accepted methods in accordance with the operator's maintenance or inspection program without obtaining approval of an AMOC, provided the RC steps, including substeps and identified figures, can still be done as specified, and the airplane can be put back in an airworthy condition.

    (j) Related Information

    (1) For more information about this AD, contact Chandra Ramdoss, Aerospace Engineer, Airframe Branch, ANM-120L, FAA, Los Angeles ACO, 3960 Paramount Boulevard, Lakewood, CA 90712-4137; phone: 562-627-5239; fax: 562-627-5210; email: [email protected]

    (2) For service information identified in this AD, contact Boeing Commercial Airplanes, Attention: Data & Services Management, P.O. Box 3707, MC 2H-65, Seattle, WA 98124-2207; telephone: 206-544-5000, extension 1; fax: 206-766-5680; Internet: https://www.myboeingfleet.com. You may view this referenced service information at the FAA, Transport Airplane Directorate, 1601 Lind Avenue SW., Renton, WA. For information on the availability of this material at the FAA, call 425-227-1221.

    Issued in Renton, Washington, on September 27, 2016. Dionne Palermo, Acting Manager, Transport Airplane Directorate, Aircraft Certification Service.
    [FR Doc. 2016-23936 Filed 10-3-16; 8:45 am] BILLING CODE 4910-13-P
    DEPARTMENT OF TRANSPORTATION Federal Aviation Administration 14 CFR Part 39 [Docket No. FAA-2019-9184; Directorate Identifier 2016-NM-060-AD] RIN 2120-AA64 Airworthiness Directives; The Boeing Company Airplanes AGENCY:

    Federal Aviation Administration (FAA), DOT.

    ACTION:

    Notice of proposed rulemaking (NPRM).

    SUMMARY:

    We propose to adopt a new airworthiness directive (AD) for all The Boeing Company Model 727 airplanes. This proposed AD was prompted by analysis of the cam support assemblies of the main cargo door that indicated the repetitive high frequency eddy current (HFEC) inspections required by the existing maintenance program are not adequate to detect cracks before two adjacent cam support assemblies of the main cargo door could fail. This proposed AD would require repetitive ultrasonic inspections for cracking of the cam support assemblies of the main cargo door and replacement if necessary. We are proposing this AD to detect and correct cracking of the cam support assemblies of the main cargo door. Such cracking could result in reduced structural integrity of the main cargo door and consequent rapid decompression of the airplane.

    DATES:

    We must receive comments on this proposed AD by November 18, 2016.

    ADDRESSES:

    You may send comments, using the procedures found in 14 CFR 11.43 and 11.45, by any of the following methods:

    Federal eRulemaking Portal: Go to http://www.regulations.gov. Follow the instructions for submitting comments.

    Fax: 202-493-2251.

    Mail: U.S. Department of Transportation, Docket Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New Jersey Avenue SE., Washington, DC 20590.

    Hand Delivery: Deliver to Mail address above between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays.

    For service information identified in this NPRM, contact Boeing Commercial Airplanes, Attention: Data & Services Management, P.O. Box 3707, MC 2H-65, Seattle, WA 98124-2207; telephone: 206-544-5000, extension 1; fax: 206-766-5680; Internet: https://www.myboeingfleet.com. You may view this referenced service information at the FAA, Transport Airplane Directorate, 1601 Lind Avenue SW., Renton, WA. For information on the availability of this material at the FAA, call 425-227-1221. It is also available on the internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2016-9184.

    Examining the AD Docket

    You may examine the AD docket on the Internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2016-9184; or in person at the Docket Management Facility between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays. The AD docket contains this proposed AD, the regulatory evaluation, any comments received, and other information. The street address for the Docket Office (phone: 800-647-5527) is in the ADDRESSES section. Comments will be available in the AD docket shortly after receipt.

    FOR FURTHER INFORMATION CONTACT:

    Chandra Ramdoss, Aerospace Engineer, Airframe Branch, ANM-120L, FAA, Los Angeles Aircraft Certification Office (ACO), 3960 Paramount Boulevard, Lakewood, CA 90712-4137; phone: 562-627-5239; fax: 562-627-5210; email: [email protected]

    SUPPLEMENTARY INFORMATION: Comments Invited

    We invite you to send any written relevant data, views, or arguments about this proposal. Send your comments to an address listed under the ADDRESSES section. Include “Docket No. FAA-2016-9184; Directorate Identifier 2016-NM-060-AD” at the beginning of your comments. We specifically invite comments on the overall regulatory, economic, environmental, and energy aspects of this proposed AD. We will consider all comments received by the closing date and may amend this proposed AD because of those comments.

    We will post all comments we receive, without change, to http://www.regulations.gov, including any personal information you provide. We will also post a report summarizing each substantive verbal contact we receive about this proposed AD.

    Discussion

    We have received a report indicating that the analysis of the cam support assemblies of the main cargo door, having part numbers 69-23588-5 and 69-23588-6, indicated that the repetitive HFEC inspections required by the existing maintenance program are not adequate to detect cracks before two adjacent cam support assemblies of the main cargo door could fail. This condition, if not corrected, could result in reduced structural integrity of the main cargo door and consequent rapid decompression of the airplane.

    Related Service Information Under 1 CFR Part 51

    We reviewed Boeing Alert Service Bulletin 727-52A0151, dated February 12, 2016. The service information describes procedures for an ultrasonic inspection of the cam support assemblies of the main cargo door for cracking, and replacement if necessary. This service information is reasonably available because the interested parties have access to it through their normal course of business or by the means identified in the ADDRESSES section.

    FAA's Determination

    We are proposing this AD because we evaluated all the relevant information and determined the unsafe condition described previously is likely to exist or develop in other products of the same type design.

    Proposed AD Requirements

    This proposed AD would require accomplishing the actions specified in the service information described previously, except as discussed under “Differences Between this Proposed AD and the Service Information.” For information on the procedures and compliance times, see this service information at http://www.regulations.gov by searching for and locating Docket No. FAA-2016-9184.

    Differences Between This Proposed AD and the Service Information

    Boeing Alert Service Bulletin 727-52A0151, dated February 12, 2016, only affects Model 727C, 727-100C, and 727-200F series airplanes. The applicability of this proposed AD extends to all Model 727 airplanes. Boeing Alert Service Bulletin 727-52A0151, dated February 12, 2016, only affects certain part numbers. We are extending the list of affected part numbers to include 69-23588-1 and 69-23588-2, which were not referenced in Boeing Alert Service Bulletin 727-52A0151, dated February 12, 2016. These differences exist to ensure all affected parts are inspected in accordance with the Accomplishment Instructions of Boeing Alert Service Bulletin 727-52A0151, dated February 12, 2016. For all airplanes affected by this AD, including airplanes not listed in the effectivity of Boeing Alert Service Bulletin 727-52A0151, dated February 12, 2016, compliance with paragraph (h) of this AD must be done using Boeing Alert Service Bulletin 727-52A0151, dated February 12, 2016. Therefore, an alternative method of compliance (AMOC) approval is not necessary for those airplanes if Boeing Alert Service Bulletin 727-52A0151, dated February 12, 2016, is used. This difference has been coordinated with Boeing.

    Costs of Compliance

    We estimate that this proposed AD affects 45 airplanes of U.S. registry. We estimate the following costs to comply with this proposed AD:

    Estimated Costs Action Labor cost Parts cost Cost per product Cost on U.S. operators Inspection 6 work-hours × $85 per hour = $510 per inspection cycle $0 $510 per inspection cycle $22,950 per inspection cycle.

    We estimate the following costs to do any necessary replacements that would be required based on the results of the proposed inspection. We have no way of determining the number of aircraft that might need this replacement:

    On-Condition Costs Action Labor cost Parts cost Cost per
  • product
  • Replacement 60 work-hours × $85 per hour = $5,100 $14,107 $19,207
    Authority for This Rulemaking

    Title 49 of the United States Code specifies the FAA's authority to issue rules on aviation safety. Subtitle I, section 106, describes the authority of the FAA Administrator. Subtitle VII: Aviation Programs, describes in more detail the scope of the Agency's authority.

    We are issuing this rulemaking under the authority described in Subtitle VII, Part A, Subpart III, Section 44701: “General requirements.” Under that section, Congress charges the FAA with promoting safe flight of civil aircraft in air commerce by prescribing regulations for practices, methods, and procedures the Administrator finds necessary for safety in air commerce. This regulation is within the scope of that authority because it addresses an unsafe condition that is likely to exist or develop on products identified in this rulemaking action.

    Regulatory Findings

    We determined that this proposed AD would not have federalism implications under Executive Order 13132. This proposed AD would not have a substantial direct effect on the States, on the relationship between the national Government and the States, or on the distribution of power and responsibilities among the various levels of government.

    For the reasons discussed above, I certify this proposed regulation:

    (1) Is not a “significant regulatory action” under Executive Order 12866,

    (2) Is not a “significant rule” under the DOT Regulatory Policies and Procedures (44 FR 11034, February 26, 1979),

    (3) Will not affect intrastate aviation in Alaska, and

    (4) Will not have a significant economic impact, positive or negative, on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.

    List of Subjects in 14 CFR Part 39

    Air transportation, Aircraft, Aviation safety, Incorporation by reference, Safety.

    The Proposed Amendment

    Accordingly, under the authority delegated to me by the Administrator, the FAA proposes to amend 14 CFR part 39 as follows:

    PART 39—AIRWORTHINESS DIRECTIVES 1. The authority citation for part 39 continues to read as follows: Authority:

    49 U.S.C. 106(g), 40113, 44701.

    § 39.13 [Amended]
    2. The FAA amends § 39.13 by adding the following new airworthiness directive (AD):

    The Boeing Company: Docket No. FAA-2016-9184; Directorate Identifier 2016-NM-060-AD.

    (a) Comments Due Date

    We must receive comments by November 18, 2016.

    (b) Affected ADs

    None.

    (c) Applicability

    This AD applies to all The Boeing Company Model 727, 727C, 727-100, 727-100C, 727-200, and 727-200F series airplanes, certificated in any category,

    (d) Subject

    Air Transport Association (ATA) of America Code 52, Doors.

    (e) Unsafe Condition

    This AD was prompted by analysis of the cam support assemblies of the main cargo door that indicated the repetitive high frequency eddy current (HFEC) inspection required by the existing maintenance program are not adequate to detect cracks before two adjacent cam support assemblies of the main cargo door could fail. We are issuing this AD to detect and correct cracking of the cam support assemblies of the main cargo door. Such cracking could result in reduced structural integrity of the main cargo door and consequent rapid decompression of the airplane.

    (f) Compliance

    Comply with this AD within the compliance times specified, unless already done.

    (g) Inspection To Determine Part Numbers

    At the later of the times specified in paragraphs (g)(1) and (g)(2) of this AD: Inspect the cam support assemblies of the main cargo door to determine whether part number (P/N) 69-23588-1, 69-23588-2, 69-23588-5, 69-23588-6, 69-23588-9, or 69-23588-10 is installed. A review of airplane maintenance records is acceptable in lieu of this inspection if the part number(s) of the cam support assemblies of the main cargo door can be conclusively determined from that review.

    (1) Before the accumulation of 18,000 total flight cycles.

    (2) Within 1,771 flight cycles or 27 months after the effective date of this AD, whichever occurs later.

    (h) Repetitive Inspections of the Cam Support Assemblies of the Main Cargo Door and Corrective Actions

    If, during any inspection required by paragraph (g) of this AD, any cam support assembly of the main cargo door having P/N 69-23588-1, 69-23588-2, 69-23588-5, 69-23588-6, 69-23588-9, or 69-23588-10 is determined to be installed: At the later of the times specified in paragraphs (g)(1) and (g)(2) of this AD, do an ultrasonic inspection to detect cracking of the affected cam support assemblies of the main cargo door; and do all applicable replacements; in accordance with the Accomplishment Instructions of Boeing Alert Service Bulletin 727-52A0151, dated February 12, 2016. Do all applicable replacements before further flight. Repeat the inspections thereafter at the applicable time specified in paragraph 1.E., “Compliance,” of Boeing Alert Service Bulletin 727-52A0151, dated February 12, 2016.

    (i) Alternative Methods of Compliance (AMOCs)

    (1) The Manager, Los Angeles Aircraft Certification Office (ACO), FAA, has the authority to approve AMOCs for this AD, if requested using the procedures found in 14 CFR 39.19. In accordance with 14 CFR 39.19, send your request to your principal inspector or local Flight Standards District Office, as appropriate. If sending information directly to the manager of the ACO, send it to the attention of the person identified in paragraph (j)(1) of this AD. Information may be emailed to: [email protected]

    (2) Before using any approved AMOC, notify your appropriate principal inspector, or lacking a principal inspector, the manager of the local flight standards district office/certificate holding district office.

    (3) An AMOC that provides an acceptable level of safety may be used for any repair, modification, or alteration required by this AD if it is approved by the Boeing Commercial Airplanes Organization Designation Authorization (ODA) that has been authorized by the Manager, Los Angeles ACO, to make those findings. To be approved, the repair method, modification deviation, or alteration deviation must meet the certification basis of the airplane, and the approval must specifically refer to this AD.

    (4) For service information that contains steps that are labeled as Required for Compliance (RC), the provisions of paragraphs (i)(4)(i) and (i)(4)(ii) of this AD apply.

    (i) The steps labeled as RC, including substeps under an RC step and any figures identified in an RC step, must be done to comply with the AD. If a step or substep is labeled “RC Exempt,” then the RC requirement is removed from that step or substep. An AMOC is required for any deviations to RC steps, including substeps and identified figures.

    (ii) Steps not labeled as RC may be deviated from using accepted methods in accordance with the operator's maintenance or inspection program without obtaining approval of an AMOC, provided the RC steps, including substeps and identified figures, can still be done as specified, and the airplane can be put back in an airworthy condition.

    (j) Related Information

    (1) For more information about this AD, contact Chandra Ramdoss, Aerospace Engineer, Airframe Branch, ANM-120L, FAA, Los Angeles ACO, 3960 Paramount Boulevard, Lakewood, CA 90712-4137; phone: 562-627-5239; fax: 562-627-5210; email: [email protected]

    (2) For service information identified in this AD, contact Boeing Commercial Airplanes, Attention: Data & Services Management, P.O. Box 3707, MC 2H-65, Seattle, WA 98124-2207; telephone: 206-544-5000, extension 1; fax: 206-766-5680; Internet: https://www.myboeingfleet.com. You may view this referenced service information at the FAA, Transport Airplane Directorate, 1601 Lind Avenue SW., Renton, WA. For information on the availability of this material at the FAA, call 425-227-1221.

    Issued in Renton, Washington, on September 27, 2016. Dionne Palermo, Acting Manager, Transport Airplane Directorate, Aircraft Certification Service.
    [FR Doc. 2016-23938 Filed 10-3-16; 8:45 am] BILLING CODE 4910-13-P
    DEPARTMENT OF TRANSPORTATION Federal Aviation Administration 14 CFR Part 39 [Docket No. FAA-2016-9183; Directorate Identifier 2016-NM-059-AD] RIN 2120-AA64 Airworthiness Directives; The Boeing Company Airplanes AGENCY:

    Federal Aviation Administration (FAA), DOT.

    ACTION:

    Notice of proposed rulemaking (NPRM).

    SUMMARY:

    We propose to adopt a new airworthiness directive (AD) for all The Boeing Company Model 707 airplanes. This proposed AD was prompted by analysis of the cam support assemblies of the main cargo door that indicated the repetitive high frequency eddy current (HFEC) inspections required by the existing maintenance program are not adequate to detect cracks before two adjacent cam support assemblies of the main cargo door could fail. This proposed AD would require repetitive ultrasonic inspections for cracking of the cam support assemblies of the main cargo door and replacement if necessary. We are proposing this AD to detect and correct cracking of the cam support assemblies of the main cargo door. Such cracking could result in reduced structural integrity of the main cargo door and consequent rapid decompression of the airplane.

    DATES:

    We must receive comments on this proposed AD by November 18, 2016.

    ADDRESSES:

    You may send comments, using the procedures found in 14 CFR 11.43 and 11.45, by any of the following methods:

    Federal eRulemaking Portal: Go to http://www.regulations.gov. Follow the instructions for submitting comments.

    Fax: 202-493-2251.

    Mail: U.S. Department of Transportation, Docket Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New Jersey Avenue SE., Washington, DC 20590.

    Hand Delivery: Deliver to Mail address above between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays.

    For service information identified in this NPRM, contact Boeing Commercial Airplanes, Attention: Data & Services Management, P.O. Box 3707, MC 2H-65, Seattle, WA 98124-2207; telephone: 206-544-5000, extension 1; fax: 206-766-5680; Internet: https://www.myboeingfleet.com. You may view this referenced service information at the FAA, Transport Airplane Directorate, 1601 Lind Avenue SW., Renton, WA. For information on the availability of this material at the FAA, call 425-227-1221. It is also available on the internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2016-9183.

    Examining the AD Docket

    You may examine the AD docket on the Internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2016-9183; or in person at the Docket Management Facility between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays. The AD docket contains this proposed AD, the regulatory evaluation, any comments received, and other information. The street address for the Docket Office (phone: 800-647-5527) is in the ADDRESSES section. Comments will be available in the AD docket shortly after receipt.

    FOR FURTHER INFORMATION CONTACT:

    Chandra Ramdoss, Aerospace Engineer, Airframe Branch, ANM-120L, FAA, Los Angeles Aircraft Certification Office (ACO), 3960 Paramount Boulevard, Lakewood, CA 90712-4137; phone: 562-627-5239; fax: 562-627-5210; email: [email protected]

    SUPPLEMENTARY INFORMATION: Comments Invited

    We invite you to send any written relevant data, views, or arguments about this proposal. Send your comments to an address listed under the ADDRESSES section. Include “Docket No. FAA-2016-9183; Directorate Identifier 2016-NM-059-AD” at the beginning of your comments. We specifically invite comments on the overall regulatory, economic, environmental, and energy aspects of this proposed AD. We will consider all comments received by the closing date and may amend this proposed AD because of those comments.

    We will post all comments we receive, without change, to http://www.regulations.gov, including any personal information you provide. We will also post a report summarizing each substantive verbal contact we receive about this proposed AD.

    Discussion

    We have received a report indicating that the analysis of the cam support assemblies of the main cargo door, part numbers 69-23588-5 and 69-23588-6, indicated that the repetitive HFEC inspections required by the existing maintenance program are not adequate to detect cracks before two adjacent cam support assemblies of the main cargo door could fail. This condition, if not corrected, could result in reduced structural integrity of the main cargo door and consequent rapid decompression of the airplane.

    Related Service Information Under 1 CFR Part 51

    We reviewed Boeing 707 Alert Service Bulletin A3542, dated February 12, 2016. The service information describes procedures for an ultrasonic inspection of the cam support assemblies of the main cargo door for cracking, and replacement if necessary. This service information is reasonably available because the interested parties have access to it through their normal course of business or by the means identified in the ADDRESSES section.

    FAA's Determination

    We are proposing this AD because we evaluated all the relevant information and determined the unsafe condition described previously is likely to exist or develop in other products of the same type design.

    Proposed AD Requirements

    This proposed AD would require accomplishing the actions specified in the service information described previously, except as discussed under “Differences Between this Proposed AD and the Service Information.” For information on the procedures and compliance times, see this service information at http://www.regulations.gov by searching for and locating Docket No. FAA-2016-9183.

    Differences Between This Proposed AD and the Service Information

    Boeing 707 Alert Service Bulletin A3542, dated February 12, 2016, only affects Model 707-300B and -300C airplanes. The applicability of this proposed AD extends to all Model 707 airplanes. Boeing 707 Alert Service Bulletin A3542, dated February 12, 2016, only affects certain part numbers. We are extending the list of affected part numbers to include 69-23588-1 and 69-23588-2, which are not referenced in Boeing 707 Alert Service Bulletin A3542, dated February 12, 2016. These differences exist to ensure all affected parts are inspected in accordance with the Accomplishment Instructions of Boeing 707 Alert Service Bulletin A3542, dated February 12, 2016. For all airplanes affected by this AD, including airplanes not listed in the effectivity of Boeing 707 Alert Service Bulletin A3542, dated February 12, 2016, compliance with paragraph (h) of this AD must be done using Boeing 707 Alert Service Bulletin A3542, dated February 12, 2016. Therefore, an alternative method of compliance (AMOC) approval is not necessary for those airplanes if Boeing 707 Alert Service Bulletin A3542, dated February 12, 2016, is used. This difference has been coordinated with Boeing.

    Costs of Compliance

    We estimate that this proposed AD affects 12 airplanes of U.S. registry. We estimate the following costs to comply with this proposed AD:

    Estimated Costs Action Labor cost Parts cost Cost per product Cost on U.S. operators Inspection 6 work-hours × $85 per hour = $510 per inspection cycle $0 $510 per inspection cycle $22,950 per inspection cycle.

    We estimate the following costs to do any necessary replacements that would be required based on the results of the proposed inspection. We have no way of determining the number of aircraft that might need this replacement:

    On-Condition Costs Action Labor cost Parts cost Cost per
  • product
  • Replacement 60 work-hours × $85 per hour = $5,100 $14,107 $19,207.
    Authority for This Rulemaking

    Title 49 of the United States Code specifies the FAA's authority to issue rules on aviation safety. Subtitle I, section 106, describes the authority of the FAA Administrator. Subtitle VII: Aviation Programs, describes in more detail the scope of the Agency's authority.

    We are issuing this rulemaking under the authority described in Subtitle VII, Part A, Subpart III, Section 44701: “General requirements.” Under that section, Congress charges the FAA with promoting safe flight of civil aircraft in air commerce by prescribing regulations for practices, methods, and procedures the Administrator finds necessary for safety in air commerce. This regulation is within the scope of that authority because it addresses an unsafe condition that is likely to exist or develop on products identified in this rulemaking action.

    Regulatory Findings

    We determined that this proposed AD would not have federalism implications under Executive Order 13132. This proposed AD would not have a substantial direct effect on the States, on the relationship between the national Government and the States, or on the distribution of power and responsibilities among the various levels of government.

    For the reasons discussed above, I certify this proposed regulation:

    (1) Is not a “significant regulatory action” under Executive Order 12866,

    (2) Is not a “significant rule” under the DOT Regulatory Policies and Procedures (44 FR 11034, February 26, 1979),

    (3) Will not affect intrastate aviation in Alaska, and

    (4) Will not have a significant economic impact, positive or negative, on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.

    List of Subjects in 14 CFR Part 39

    Air transportation, Aircraft, Aviation safety, Incorporation by reference, Safety.

    The Proposed Amendment

    Accordingly, under the authority delegated to me by the Administrator, the FAA proposes to amend 14 CFR part 39 as follows:

    PART 39—AIRWORTHINESS DIRECTIVES 1. The authority citation for part 39 continues to read as follows: Authority:

    49 U.S.C. 106(g), 40113, 44701.

    § 39.13 [Amended]
    2. The FAA amends § 39.13 by adding the following new airworthiness directive (AD):

    The Boeing Company: Docket No. FAA-2016-9183; Directorate Identifier 2016-NM-059-AD.

    (a) Comments Due Date

    We must receive comments by November 18, 2016.

    (b) Affected ADs

    None.

    (c) Applicability

    This AD applies to all The Boeing Company Model 707-100 Long Body, -200, -100B Long Body, and -100B Short Body series airplanes; and Model 707-300, -300B, -300C, and -400 series airplanes; certificated in any category,

    (d) Subject

    Air Transport Association (ATA) of America Code 52, Doors.

    (e) Unsafe Condition

    This AD was prompted by analysis of the cam support assemblies of the main cargo door that indicated the repetitive high frequency eddy current (HFEC) inspections required by the existing maintenance program are not adequate to detect cracks before two adjacent cam support assemblies of the main cargo door could fail. We are issuing this AD to detect and correct cracking of the cam support assemblies of the main cargo door. Such cracking could result in reduced structural integrity of the main cargo door and consequent rapid decompression of the airplane.

    (f) Compliance

    Comply with this AD within the compliance times specified, unless already done.

    (g) Inspection To Determine Part Numbers

    At the later of the times specified in paragraphs (g)(1) and (g)(2) of this AD: Inspect the cam support assemblies of the main cargo door to determine whether part number (P/N) 69-23588-1, 69-23588-2, 69-23588-5, 69-23588-6, 69-23588-9, or 69-23588-10 is installed. A review of airplane maintenance records is acceptable in lieu of this inspection if the part number(s) of the cam support assemblies of the main cargo door can be conclusively determined from that review.

    (1) Before the accumulation of 18,000 total flight cycles.

    (2) Within 1,790 flight cycles or 24 months after the effective date of this AD, whichever occurs later.

    (h) Repetitive Inspections for the Cam Support Assemblies of the Main Cargo Door and Corrective Actions

    If, during any inspection required by paragraph (g) of this AD, any cam support assembly of the main cargo door having P/N 69-23588-1, 69-23588-2, 69-23588-5, 69-23588-6, 69-23588-9, or 69-23588-10 is determined to be installed: Except as required by paragraph (i) of this AD, at the applicable time specified in paragraph 1.E., “Compliance,” of Boeing 707 Alert Service Bulletin A3542, dated February 12, 2016, do an ultrasonic inspection to detect cracking of the affected cam support assemblies of the main cargo door, and do all applicable replacements, in accordance with the Accomplishment Instructions of Boeing 707 Alert Service Bulletin A3542, dated February 12, 2016. Do all applicable replacements before further flight. Repeat the inspections thereafter at the applicable time specified in paragraph 1.E., “Compliance,” of Boeing 707 Alert Service Bulletin A3542, dated February 12, 2016.

    (i) Service Information Exception

    Where Boeing 707 Alert Service Bulletin A3542, dated February 12, 2016, specifies a compliance time “after the original issue date of this service bulletin,” this AD requires compliance within the specified compliance time after the effective date of this AD.

    (j) Alternative Methods of Compliance (AMOCs)

    (1) The Manager, Los Angeles Aircraft Certification Office (ACO), FAA, has the authority to approve AMOCs for this AD, if requested using the procedures found in 14 CFR 39.19. In accordance with 14 CFR 39.19, send your request to your principal inspector or local Flight Standards District Office, as appropriate. If sending information directly to the manager of the ACO, send it to the attention of the person identified in paragraph (k)(1) of this AD. Information may be emailed to: [email protected]

    (2) Before using any approved AMOC, notify your appropriate principal inspector, or lacking a principal inspector, the manager of the local flight standards district office/certificate holding district office.

    (3) An AMOC that provides an acceptable level of safety may be used for any repair, modification, or alteration required by this AD if it is approved by the Boeing Commercial Airplanes Organization Designation Authorization (ODA) that has been authorized by the Manager, Los Angeles ACO, to make those findings. To be approved, the repair method, modification deviation, or alteration deviation must meet the certification basis of the airplane, and the approval must specifically refer to this AD.

    (4) For service information that contains steps that are labeled as Required for Compliance (RC), the provisions of paragraphs (j)(4)(i) and (j)(4)(ii) of this AD apply.

    (i) The steps labeled as RC, including substeps under an RC step and any figures identified in an RC step, must be done to comply with the AD. If a step or substep is labeled “RC Exempt,” then the RC requirement is removed from that step or substep. An AMOC is required for any deviations to RC steps, including substeps and identified figures.

    (ii) Steps not labeled as RC may be deviated from using accepted methods in accordance with the operator's maintenance or inspection program without obtaining approval of an AMOC, provided the RC steps, including substeps and identified figures, can still be done as specified, and the airplane can be put back in an airworthy condition.

    (k) Related Information

    (1) For more information about this AD, contact Chandra Ramdoss, Aerospace Engineer, Airframe Branch, ANM-120L, FAA, Los Angeles ACO, 3960 Paramount Boulevard, Lakewood, CA 90712-4137; phone: 562-627-5239; fax: 562-627-5210; email: [email protected]

    (2) For service information identified in this AD, contact Boeing Commercial Airplanes, Attention: Data & Services Management, P.O. Box 3707, MC 2H-65, Seattle, WA 98124-2207; telephone: 206-544-5000, extension 1; fax: 206-766-5680; Internet: https://www.myboeingfleet.com. You may view this referenced service information at the FAA, Transport Airplane Directorate, 1601 Lind Avenue SW., Renton, WA. For information on the availability of this material at the FAA, call 425-227-1221.

    Issued in Renton, Washington, on September 27, 2016. Dionne Palermo, Acting Manager, Transport Airplane Directorate, Aircraft Certification Service.
    [FR Doc. 2016-23939 Filed 10-3-16; 8:45 am] BILLING CODE 4910-13-P
    DEPARTMENT OF THE TREASURY Internal Revenue Service 26 CFR Part 1 [REG-163113-02] RIN 1545-BB71 Estate, Gift, and Generation-Skipping Transfer Taxes; Restrictions on Liquidation of an Interest; Correction AGENCY:

    Internal Revenue Service (IRS), Treasury.

    ACTION:

    Correction to notice of proposed rulemaking.

    SUMMARY:

    This document contains a correction to a notice of proposed rulemaking (REG-163113-02) that was published in the Federal Register on Thursday, August 4, 2016 (81 FR 51413). The proposed regulations concern the valuation of interests in corporations and partnerships for estate, gift, and generation-skipping transfer tax purposes.

    DATES:

    Written or electronic comments and outlines of topics to be discussed at the public hearing scheduled for December 1, 2016, for the notice of proposed rulemaking at 81 FR 51413, August 4, 2016, are still being accepted and must be received by November 2, 2016.

    ADDRESSES:

    Send submissions to CC:PA:LPD:PR (REG-163113-02), Room 5203, Internal Revenue Service, P.O. Box 7604, Ben Franklin Station, Washington, DC 20044. Submissions may be hand delivered Monday through Friday between the hours of 8 a.m. and 4 p.m. to CC:PA:LPD:PR (REG-163113-02), Courier's desk, Internal Revenue Service, 1111 Constitution Avenue NW., Washington, DC 20224, or sent electronically, via the Federal eRulemaking Portal at www.regulations.gov (IRS REG-163113-02).

    FOR FURTHER INFORMATION CONTACT:

    John D. MacEachen, at (202) 317-6859 (not a toll-free number).

    SUPPLEMENTARY INFORMATION:

    Background

    The notice of proposed rulemaking that is the subject of this document is under section 2704 of the Internal Revenue Code.

    Need for Correction

    As published, the notice of proposed rulemaking (REG-163113-02) contains an error that is misleading and is in need of clarification.

    Correction to Publication

    Accordingly, the notice of proposed rulemaking, that is the subject of FR Doc. 2016-18370, is corrected as follows:

    1. On page 51418, in the third column, under the paragraph heading “Effective Dates”, in the second line from the top of the paragraph, the language “proposed to be effective on and after the” is corrected to read “proposed to be effective on the”.

    Martin V. Franks, Chief, Publications and Regulations Branch, Legal Processing Division, Associate Chief Counsel, (Procedure and Administration).
    [FR Doc. 2016-23957 Filed 10-3-16; 8:45 am] BILLING CODE 4830-01-P
    ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 52 [EPA-R09-OAR-2016-0291; FRL-9952-12-Region 9] Approval of California Air Plan Revisions, Sacramento Metropolitan Air Quality Management District and San Diego County Air Pollution Control District AGENCY:

    Environmental Protection Agency (EPA).

    ACTION:

    Proposed rule.

    SUMMARY:

    The Environmental Protection Agency (EPA) is proposing to approve revisions to the Sacramento Metropolitan Air Quality Management District (SMAQMD) and the San Diego County Air Pollution Control District (SDCAPCD) portions of the California State Implementation Plan (SIP). These revisions concern volatile organic compound (VOC) emissions from architectural coatings. We are proposing to approve local rules and a rule rescission to regulate these emission sources under the Clean Air Act (CAA or the Act).

    DATES:

    Any comments on this proposal must arrive by November 3, 2016.

    ADDRESSES:

    Submit your comments, identified by Docket ID No. EPA-R09-OAR-2016-0291 at http://www.regulations.gov, or via email to [email protected] For comments submitted at Regulations.gov, follow the online instructions for submitting comments. Once submitted, comments cannot be edited or removed from Regulations.gov. For either manner of submission, the EPA may publish any comment received to its public docket. Do not submit electronically any information you consider to be Confidential Business Information (CBI) or other information whose disclosure is restricted by statute. Multimedia submissions (audio, video, etc.) must be accompanied by a written comment. The written comment is considered the official comment and should include discussion of all points you wish to make. The EPA will generally not consider comments or comment contents located outside of the primary submission (i.e. on the Web, cloud, or other file sharing system). For additional submission methods, please contact the person identified in the FOR FURTHER INFORMATION CONTACT section. For the full EPA public comment policy, information about CBI or multimedia submissions, and general guidance on making effective comments, please visit http://www2.epa.gov/dockets/commenting-epa-dockets.

    FOR FURTHER INFORMATION CONTACT:

    Arnold Lazarus, EPA Region IX, (415) 972-3024, [email protected]

    SUPPLEMENTARY INFORMATION:

    Throughout this document, “we,” “us” and “our” refer to the EPA. This proposal addresses the following local rules: SMAQMD Rule 442, SDCAPCD Rule 67.0 (rescinded) and SDCAPCD Rule 67.0.1 (the replacement rule). In the Rules and Regulations section of this Federal Register, we are approving these local rules and rule rescission in a direct final action without prior proposal because we believe these SIP revisions are not controversial. If we receive adverse comments, however, we will publish a timely withdrawal of the direct final rule and address the comments in subsequent action based on this proposed rule.

    We do not plan to open a second comment period, so anyone interested in commenting should do so at this time. If we do not receive adverse comments, no further activity is planned. For further information, please see the direct final action.

    Dated: August 24, 2016. Alexis Strauss, Acting Regional Administrator, Region IX.
    [FR Doc. 2016-23838 Filed 10-3-16; 8:45 am] BILLING CODE 6560-50-P
    DEPARTMENT OF THE INTERIOR Fish and Wildlife Service 50 CFR Part 17 [Docket No. FWS-R6-ES-2016-0086; 4500030113] RIN 1018-BB52 Endangered and Threatened Wildlife and Plants; 12-Month Finding on a Petition To List the Western Glacier Stonefly as an Endangered or Threatened Species; Proposed Threatened Species Status for Meltwater Lednian Stonefly and Western Glacier Stonefly AGENCY:

    Fish and Wildlife Service, Interior.

    ACTION:

    Proposed rule; 12-month petition finding and status review.

    SUMMARY:

    We, the U.S. Fish and Wildlife Service (Service), announce a 12-month finding for the western glacier stonefly (Zapada glacier). After a review of the best available scientific and commercial information, we find that listing the western glacier stonefly is warranted. We are also announcing the proposed listing rule for the candidate species meltwater lednian stonefly (Lednia tumana). Therefore, we are proposing to list both the meltwater lednian stonefly and the western glacier stonefly, two insect species from Glacier National Park and northwestern Montana, as threatened species under the Endangered Species Act (Act). If we finalize this rule as proposed, it would extend the Act's protections to these species. The effect of this regulation will be to add these species to the Federal List of Endangered and Threatened Wildlife. The Service seeks data and comments from the public on this proposed listing rule.

    DATES:

    We will accept comments received or postmarked on or before December 5, 2016. Comments submitted electronically using the Federal eRulemaking Portal (see ADDRESSES below) must be received by 11:59 p.m. Eastern Time on the closing date. We must receive requests for public hearings, in writing, at the address shown in FOR FURTHER INFORMATION CONTACT by November 18, 2016.

    ADDRESSES:

    You may submit comments by one of the following methods:

    (1) Electronically: Go to the Federal eRulemaking Portal: http://www.regulations.gov. In the Search box, enter FWS-R6-ES-2016-0086, which is the docket number for this rulemaking. Then, in the Search panel on the left side of the screen, under the Document Type heading, click on the Proposed Rules link to locate this document. You may submit a comment by clicking on “Comment Now!”

    (2) By hard copy: Submit by U.S. mail or hand-delivery to: Public Comments Processing, Attn: FWS-R6-ES-2016-0086; U.S. Fish and Wildlife Service Headquarters, MS: BPHC, 5275 Leesburg Pike, Falls Church, VA 22041-3803.

    We request that you send comments only by the methods described above. We will post all comments on http://www.regulations.gov. This generally means that we will post any personal information you provide us (see Public Comments below for more information).

    FOR FURTHER INFORMATION CONTACT:

    Jodi Bush, Field Supervisor, U.S. Fish and Wildlife Service, Montana Ecological Services Field Office, 585 Shepard Way, Helena, MT 59601, by telephone 406-449-5225 or by facsimile 406-449-5339. Persons who use a telecommunications device for the deaf (TDD) may call the Federal Information Relay Service (FIRS) at 800-877-8339.

    SUPPLEMENTARY INFORMATION: Executive Summary

    Why we need to publish a rule. Under the Act, if a species is determined to be an endangered or threatened species throughout all or a significant portion of its range, we are required to promptly publish a proposal in the Federal Register and make a determination on our proposal within 1 year. Critical habitat shall be designated, to the maximum extent prudent and determinable, for any species determined to be an endangered or threatened species under the Act. Listing a species as an endangered or threatened species and designations and revisions of critical habitat can only be completed by issuing a rule. In the near future, we intend to publish a proposal to designate critical habitat for meltwater lednian stonefly and western glacier stonefly. Designation of critical habitat is prudent, but not determinable at this time.

    This document proposes the listing of the meltwater lednian stonefly and the western glacier stonefly as threatened species. The meltwater lednian stonefly is a candidate species for which we have on file sufficient information on biological vulnerability and threats to support preparation of a listing proposal, but for which development of a listing regulation has been precluded by other higher priority listing activities. We were petitioned to list the western glacier stonefly and published a substantial 90-day finding in 2011. We assessed all information regarding status of and threats to both the meltwater lednian stonefly and the western glacier stonefly that was available through August 11, 2016. However, we received additional information on western glacier stonefly on August 12, 2016, indicating a larger range than previously known. Because we received this new information late in the status review process, we were unable to fully incorporate and analyze the new information in this document in time to meet the settlement agreement deadline of submitting a 12-month finding for western glacier stonefly to the Federal Register by September 30, 2016. As such, we plan to reopen the comment period on this proposed listing rule in the near future when we have been able to fully incorporate and analyze the new information and allow the public to comment on the new information and our analysis of it at that time. The current document consists of the 12-month finding for the western glacier stonefly, for which we find listing is warranted, and proposed rules to list both stonefly species.

    The basis for our action. Under the Act, we can determine that a species is an endangered or threatened species based on any of five factors: (A) The present or threatened destruction, modification, or curtailment of its habitat or range; (B) Overutilization for commercial, recreational, scientific, or educational purposes; (C) Disease or predation; (D) The inadequacy of existing regulatory mechanisms; or (E) Other natural or manmade factors affecting its continued existence. We have determined that habitat fragmentation and degradation resulting from climate change are current and future threats to the viability of both the meltwater lednian stonefly and the western glacier stonefly. Drought is expected to be a threat to both stonefly species in the foreseeable future.

    We will seek peer review. We will seek comments from appropriate and independent specialists to ensure that our determination is based on scientifically sound data, assumptions, and analyses. We will invite these peer reviewers to comment on our listing proposal. Because we will consider all comments and information received during the comment period, our final determinations may differ from this proposal.

    Information Requested Public Comments

    We intend that any final action resulting from this proposed rule will be based on the best scientific and commercial data available and be as accurate and as effective as possible. Therefore, we request comments or information from the public, other concerned governmental agencies, Native American tribes, the scientific community, industry, or any other interested parties concerning this proposed rule. Because we will consider all comments and information received during the comment period, our final determinations may differ from this proposal. We particularly seek comments concerning:

    (1) The meltwater lednian stonefly and the western glacier stonefly biology, range, and population trends, including:

    (a) Biological or ecological requirements of the species, including habitat requirements for feeding, breeding, and sheltering;

    (b) Genetics and taxonomy;

    (c) Historical and current range including distribution patterns;

    (d) Historical and current population levels, and current and projected trends; and

    (e) Past and ongoing conservation measures for the species, their habitat, or both.

    (2) Factors that may affect the continued existence of the species, which may include habitat modification or destruction, overutilization, disease, predation, the inadequacy of existing regulatory mechanisms, or other natural or manmade factors.

    (3) Biological, commercial trade, or other relevant data concerning any threats (or lack thereof) to these species and existing regulations that may be addressing those threats.

    (4) Additional information concerning the historical and current status, range, distribution, and population size of these species, including the locations of any additional populations.

    As referenced above in the Executive Summary, we will be reopening the comment period for this proposed listing rule in the near future once we incorporate and analyze the new information we recently obtained on western glacier stonefly, which is further described under Distribution and Abundance below. During the reopening of the comment period, we will seek comments concerning the new information describing the expanded range and additional populations of western glacier stonefly.

    Please include sufficient information with your submission (such as scientific journal articles or other publications) to allow us to verify any scientific or commercial information you include.

    Please note that submissions merely stating support for or opposition to the action under consideration without providing supporting information, although noted, will not be considered in making a determination, as section 4(b)(1)(A) of the Act directs that determinations as to whether any species is a threatened or endangered species must be made “solely on the basis of the best scientific and commercial data available.”

    You may submit your comments and materials concerning this proposed rule by one of the methods listed in ADDRESSES. We request that you send comments only by the methods described in ADDRESSES.

    If you submit information via http://www.regulations.gov, your entire submission—including any personal identifying information—will be posted on the Web site. If your submission is made via a hardcopy that includes personal identifying information, you may request at the top of your document that we withhold this information from public review. However, we cannot guarantee that we will be able to do so. We will post all hardcopy submissions on http://www.regulations.gov.

    Comments and materials we receive, as well as supporting documentation we used in preparing this proposed rule, will be available for public inspection on http://www.regulations.gov, or by appointment, during normal business hours, at the U.S. Fish and Wildlife Service, Montana Ecological Services Field Office (see FOR FURTHER INFORMATION CONTACT).

    Public Hearing

    Section 4(b)(5) of the Act provides for one or more public hearings on this proposal, if requested. Requests must be received within 45 days after the date of publication of this proposed rule in the Federal Register. Such requests must be sent to the address shown in FOR FURTHER INFORMATION CONTACT. We will schedule public hearings on this proposal, if any are requested, and announce the dates, times, and places of those hearings, as well as how to obtain reasonable accommodations, in the Federal Register and local newspapers at least 15 days before the hearing.

    Peer Review

    In accordance with our joint policy on peer review published in the Federal Register on July 1, 1994 (59 FR 34270), we are seeking the expert opinions of three appropriate and independent specialists regarding this proposed rule. The purpose of peer review is to ensure that our listing determinations are based on scientifically sound data, assumptions, and analyses. The peer reviewers have expertise in stonefly biology, habitat, and life history. We invite comment from the peer reviewers during the public comment periods.

    Previous Federal Action Meltwater Lednian Stonefly

    On July 30, 2007, we received a petition from Forest Guardians (now WildEarth Guardians) requesting that the Service: (1) Consider all full species in our Mountain Prairie Region ranked by the organization NatureServe as G1 or G1G2 (which includes the meltwater lednian stonefly), except those that are currently listed, proposed for listing, or candidates for listing; and (2) list each species as either endangered or threatened (Forest Guardians 2007, pp. 1-37). We replied to the petition on August 24, 2007, and stated that, based on preliminary review, we found no compelling evidence to support an emergency listing for any of the species covered by the petition, and that we planned work on the petition in Fiscal Year (FY) 2008.

    On March 19, 2008, WildEarth Guardians filed a complaint (1:08-CV-472-CKK) indicating that the Service failed to comply with its mandatory duty to make a preliminary 90-day finding on their two multiple species petitions in two of the Service's administrative regions—one for the Mountain-Prairie Region and one for the Southwest Region (WildEarth Guardians v. Kempthorne 2008, case 1:08-CV-472-CKK). We subsequently published two initial 90-day findings on January 6, 2009 (74 FR 419), and February 5, 2009 (74 FR 6122), identifying species for which we were then making negative 90-day findings, and species for which we were still working on a determination. On March 13, 2009, the Service and WildEarth Guardians filed a stipulated settlement in the District of Columbia Court, agreeing that the Service would submit to the Federal Register a finding as to whether WildEarth Guardians' petition presents substantial information indicating that the petitioned action may be warranted for 38 Mountain-Prairie Region species by August 9, 2009 (WildEarth Guardians v. Salazar 2009, case 1:08-CV-472-CKK).

    On August 18, 2009, we published a partial 90-day finding for the 38 Mountain-Prairie Region species, and found that the petition presented substantial information to indicate that listing of the meltwater lednian stonefly may be warranted based on threats from habitat loss and degradation due to climate change, and specifically the melting of glaciers associated with the species' habitat; and went on to request further information pertaining to the species (74 FR 41649, 41659-41660).

    On April 5, 2011, we published a 12-month finding (76 FR 18684) for the meltwater lednian stonefly indicating that listing was warranted, but precluded by higher priority listing actions. At that time, the meltwater lednian stonefly was added to our list of candidate species with a listing priority number (LPN) of 4. In the 2011 candidate notice of review (76 FR 66370, October 24, 2011; p. 66376), we announced a revised LPN of 5 for the species due to research that showed the meltwater lednian stonefly was no longer considered to be a monotypic genus. In each successive year since then we reaffirmed our 2011 finding of warranted but precluded and maintained a listing priority number of 5 for the species.

    Western Glacier Stonefly

    On January 10, 2011, we received a petition to list the western glacier stonefly from the Xerces Society and Center for Biological Diversity. We replied to the petition on August 3, 2011, indicating that emergency listing was not warranted. On December 19, 2011, we published a 90-day finding (76 FR 78601) for the western glacier stonefly indicating there was substantial scientific information indicating that listing of the species may be warranted. On April 15, 2015, the Center for Biological Diversity filed an amended complaint (1:15-CV-00229-EGS) seeking 12-month findings for several species, including the western glacier stonefly. On September 15, 2015, the Service and the Center for Biological Diversity filed a stipulated settlement in the District of Columbia Court, agreeing that the Service would submit to the Federal Register a 12-month finding for the western glacier stonefly by September 30, 2016 (Center for Biological Diversity v. Jewell 2009, case 1:15-CV-00229-EGS). This document contains the status review and 12-month finding for the species.

    Because both stonefly species occupy similar habitat in the same geographic region of northwestern Montana and are faced with similar threats, we have batched them into one status review and subsequent proposed rule for efficiency. Therefore, this document constitutes both the 12-month finding and proposed listing rule for the western glacier stonefly, and the proposed listing rule for the meltwater lednian stonefly.

    Background Taxonomy and Species Description

    The meltwater lednian and western glacier stoneflies are small insects that begin life as eggs, hatch into aquatic nymphs, and later mature into winged adults, surviving briefly on land before reproducing and dying. The nymph, or aquatic juvenile stage, of the meltwater lednian stonefly is dark red-brown on its dorsal surface and pink on the ventral surface, with light grey-green legs (Baumann and Stewart 1980, p. 658). Mature nymphs can range in size from 4.5 to 6.5 millimeters (mm) (0.18 to 0.26 in.; Baumann and Stewart 1980, p. 655). Nymphs mature into the adult terrestrial phase that has wings and body sizes ranging from 4 to 6 mm (0.16 to 0.24 in.; Baumann 1975, p. 79). Western glacier stonefly nymphs are similar in color and size to meltwater stonefly nymphs. Western glacier stonefly adults are generally brown in color with yellowish brown legs and possess two sets of translucent wings (Baumann and Gaufin 1971, p. 275). Adults range from 6.5 to 10.0 millimeters (mm) (0.26 to 0.39 inches (in)) in body length (Baumann and Gaufin 1971, p. 275). Western glacier stonefly nymphs cannot be distinguished from other Zapada nymphs using gross morphological characteristics. Thus, DNA barcoding (in which DNA sequences of unidentified nymphs are compared with those of positively identified adults) must be used to positively identify western glacier stonefly nymphs.

    The meltwater lednian stonefly was originally described by Ricker in 1952 (Baumann 1975, p. 18) from the Many Glacier area of Glacier National Park (GNP), Montana (Baumann 1982, pers. comm.). The meltwater lednian stonefly belongs to the phylum Arthropoda, class Insecta, order Plecoptera (stoneflies), family Nemouridae, and subfamily Nemourinae. Until recently, the meltwater lednian stonefly was believed to be the only species in the genus Lednia (Baumann 1975, p. 19; Stewart and Harper 1996, p. 263; Stark et al. 2009, entire; 76 FR 18688). However, three additional species (L. borealis-Cascade Range, Washington; L. sierra-Sierra Madre Range, California; and L. tetonica-Wind River Range, Wyoming) have been described in the genus Lednia since 2010 (Baumann and Kondratieff 2010, entire; Baumann and Call 2012, entire). Thus, the Service no longer considers the genus Lednia to be monotypic. The meltwater lednian stonefly is recognized as a valid species by the scientific community (e.g., Baumann 1975, p. 18; Baumann et al. 1977, pp. 7, 34; Newell et al. 2008, p. 181; Stark et al. 2009, entire), and no information is available that disputes this finding. Consequently, we conclude that the meltwater lednian stonefly (Lednia tumana) is a valid species and, therefore, a listable entity under section 3(16) of the Act.

    The western glacier stonefly was first described in 1971 from adult specimens collected from five locations in GNP, Montana (Baumann and Gaufin 1971, p. 277). The western glacier stonefly is in the same family as the meltwater lednian stonefly (i.e., family Nemouridae; Baumann 1975, pp. 1, 31; Service 2011, p. 18688), but a different genus (Zapada). Members of the Zapada genus are the most common of the Nemouridae family (Baumann 1975, p. 31). The western glacier stonefly is recognized as a valid species by the scientific community (Baumann 1975, p. 30; Stark 1996, entire; Stark et al. 2009, p. 8), and no information is available that disputes this finding. Consequently, we conclude that the western glacier stonefly is a valid species and, therefore, a listable entity under section 3(16) of the Act.

    Distribution and Abundance Meltwater Lednian Stonefly

    Fifty-eight populations of meltwater lednian stoneflies are known to occur; these are located primarily within GNP, with a few populations recorded south of GNP on National Forest and tribal lands (Figure 1; Giersch and Muhlfeld 2015, in progress). Meltwater lednian stonefly occupy relatively short reaches of streams [mean = 565 meters (m) (1,854 feet; ft); range = 1-2,355 m (3-7,726 ft)] below meltwater sources (for description, see Habitat section below; Giersch and Muhlfeld 2015, in progress). Meltwater lednian stoneflies can attain moderate to high densities [(350-5,800 per square m) (32-537 per square ft)] (e.g., Logan Creek: Baumann and Stewart 1980, p. 658; NPS 2009, entire; Muhlfeld et al. 2011, p. 342; Giersch 2016, pers. comm.). Given this range of densities and a coarse assessment of available habitat, the abundance of meltwater lednian stonefly is estimated to be in the millions of individuals, however, no population trend information is available for the meltwater lednian stonefly.

    BILLING CODE 4333-15-P EP04OC16.138 BILLING CODE 4333-15-C Western Glacier Stonefly

    Four populations of the western glacier stonefly are known to occur, all within the boundaries of GNP (Figure 2; Giersch and Muhlfeld 2015, in progress). Similar to the meltwater lednian stonefly, western glacier stoneflies are found on relatively short reaches of strems in close proximity to meltwater sources [means = 508 m (1,667 ft.); range = 15-1407 m (49-4,616 ft.)] (Giersch and Muhlfeld 2015, in progress). Western glafier stoneflies can attain moderate densities [(400-2,300 per square m) (37-213 per square ft)] (Giersch 2016, pers. comm.). Given this range of densities and a coarse assessment of available habitat, the abundance of the western glacier stonefly is estimated to be in the tens of thousands of individuals, less numerous than the meltwater lednian stonefly.

    Western glacier sotneflies have decreased in distribution among and within 6 streams where the species occurred in the 1960s and 1970s in GNP (Giersch et al. 2015, p. 58). Of the four known populations of the western glacier stonelfy, three were first documented relatively recently in GNP (Giersch et al. 2015, p.59; giersch and Muhlfeld 2015, in progress). In August 2016, we received new information indicating that the distribution of western glacier stonefly extends outside of GNP, including one population in the Absaroka-Beartooth Wilderness in southwestern Montana and three populations in Grand Teton National Park, Wyoming. This distribution represents a large range expansion (500 km southward) for western glacier stonefly compared to the range previously known for the species. However, because we received this information too late in the status review process to be able to incorporate it in time to meet the settlement agreement deadline of September 30, 2016, we have not yet fully evaluated this information, or incorporated it into our analysis or this proposed rule. We intend to reopen the comment period on the proposed listing rule when this information has been fully incorporated and analyzed.

    BILLING CODE 4333-15-P EP04OC16.139 BILLING CODE 4333-15-C

    The northern distributional limits of the meltwater lednian stonefly and the western glacier stonefly are not known. Potential habitat for meltwater lednian and western glacier stoneflies, similar to what both species are currently occupying, exists in the area of Banff and Jasper National Parks, Alberta, Canada. Aquatic invertebrate surveys have been conducted in this area, and no specimens of either species were found, although it is likely that sampling did not occur close enough to glaciers or icefields to detect either meltwater lednian or western glacier stonefly, if indeed they were present (Hirose 2016, pers. comm.). Sampling in this area for both meltwater lednian and western glacier stoneflies is planned for the future and would help fill in an important data gap with regard to northern distributional limits of both species.

    Habitat Meltwater Lednian Stonefly

    The meltwater lednian stonefly is found in high-elevation, fishless, alpine streams (Baumann and Stewart 1980, p. 658; MNHP 2010a) originating from meltwater sources, including glaciers and small icefields, permanent and seasonal snowpack, alpine springs, and glacial lake outlets (Hauer et al. 2007, p. 107; Giersch and Muhlfeld 2015, in progress). Meltwater lednian stonefly are known from alpine streams where mean and maximum water temperatures do not exceed 10 °C (50 °F) and 18 °C (64 °F), respectively (Muhlfeld et al. 2011, p. 342), although the species can withstand higher water temperatures (~20 °C; 68 °F) for short periods of time (Treanor et al. 2013, p. 602). In general, the alpine streams inhabited by the meltwater lednian stonefly are presumed to have very low nutrient concentrations (low nitrogen and phosphorus), reflecting the nutrient content of the glacial or snowmelt source (Hauer et al. 2007, pp. 107-108). During the daytime, meltwater lednian stonefly nymphs prefer to occupy the underside of rocks or larger pieces of bark or wood (Baumann and Stewart 1980, p. 658; Giersch and Muhlfeld 2015, in progress).

    Western Glacier Stonefly

    Western glacier stoneflies are found in high-elevation, fishless, alpine streams closely linked to the same meltwater sources as the meltwater lednian stonefly (Giersch and Muhlfeld 2015, in progress). The specific thermal tolerances of the western glacier stonefly are not known. However, all recent collections of the western glacier stonefly in GNP have occurred in habitats with daily maximum water temperatures less than 6.3 °C (43 °F) (Giersch et al. 2015, p. 61). Further, abundance patterns for other species in the Zapada genus in GNP indicate preferences for the coolest environmental temperatures, such as those found at high elevation in proximity to headwater sources (Hauer et al. 2007, p. 110). Daytime microhabitat preferences of the western glacier stonefly appear similar to those for the meltwater lednian stonefly (Giersch and Muhlfeld 2015, in progress).

    Biology

    Little information is available on the biology of the meltwater lednian and western glacier stoneflies. However, we assume that both species are likely to be similar to other closely related stoneflies in the Nemouridae family in terms of habitat needs and life-history traits. In general, Nemouridae stoneflies are primarily associated with clean, cool or cold, flowing waters (Baumann 1979, pp. 242-243; Stewart and Harper 1996, p. 217). Eggs and nymphs of Nemouridae stoneflies are aquatic (Stewart and Harper 1996, p. 217), and nymphs rely on perennial water sources to breathe through gills, similar to fish. Nemouridae nymphs are typically herbivores or detritivores, and their feeding mode is generally that of a shredder or collector-gatherer (Baumann 1975, p. 1; Stewart and Harper 1996, pp. 218, 262). Typically, Nemouridae stoneflies complete their life cycles within a single year (univoltine) or in 2 to 3 years (semivoltine) (Stewart and Harper 1996, pp. 217-218).

    Mature stonefly nymphs emerge from the water and complete their development in the terrestrial environment as short-lived adults on and around streamside vegetation or other structures (Hynes 1976, pp. 135-136; Stewart and Harper 1996, p. 217). It is unknown if adult stoneflies select for particular features in the terrestrial environment. Timing of stonefly emergence is influenced by temperature and amount of daylight (Nebeker 1971 cited in Hynes 1976, p. 137). Adult meltwater lednian stoneflies are believed to emerge and breed in August and September (Baumann and Stewart 1980, p. 658; Giersch 2010b, pers. comm.; MNHP 2010a). Adult western glacier stoneflies have been collected from land in early July through mid-August (Baumann and Gaufin 1971, p. 277), almost immediately after snow has melted and exposed streams.

    Nemouridae stoneflies disperse longitudinally (up or down stream) or laterally to the stream bank from their benthic (nymphal) source (Hynes 1976, p. 138; Griffith et al. 1998, p. 195; Petersen et al. 2004, pp. 944-945). Generally, adult stoneflies stay close to the channel of their source stream (Petersen et al. 2004, p. 946), and lateral movement into neighboring uplands is confined to less than 80 meters (262 feet) from the stream (Griffith et al. 1998, p. 197). Thus, Nemouridae stoneflies, and likely meltwater lednian and western glacier stoneflies, have limited dispersal capabilities.

    Adult male and female stoneflies are mutually attracted by a drumming sound produced by tapping their abdomens on a substrate (Hynes 1976, p. 140). After mating, females deposit a mass of fertilized eggs in water where they are widely dispersed or attached to substrates by sticky coverings or specialized anchoring devices (Hynes 1976, p. 141; Stewart and Harper 1996, p. 217). Eggs may hatch within a few weeks or remain in diapause (dormancy) for much longer periods if environmental conditions, such as temperature, are not conducive to development (Hynes 1976, p. 142). Environmental conditions also may affect the growth and development of hatchlings (Stewart and Harper 1996, p. 217).

    Summary of Biological Status and Threats

    The Act directs us to determine whether any species is an endangered species or a threatened species because of any factors affecting its continued existence. In this section, we summarize the biological condition of these species and their resources, and the influences on such to assess both species' overall viability and the risks to that viability.

    In considering what factors might constitute threats to a species, we must look beyond the exposure of the species to a factor to evaluate whether the species may respond to the factor in a way that causes actual impacts to the species. If there is exposure to a factor and the species responds negatively, the factor may be a threat and we attempt to determine how significant a threat it is. The threat is significant if it drives, or contributes to, the risk of extinction of the species such that the species warrants listing as endangered or threatened as those terms are defined in the Act.

    Factor A. The Present or Threatened Destruction, Modification, or Curtailment of Its Habitat or Range

    Meltwater lednian and western glacier stoneflies occupy remote, high-elevation alpine habitats in GNP and several proximate watersheds. The remoteness of these habitats largely precludes overlap with human uses and typical land management activities (e.g., forestry, mining, irrigation) that have historically modified habitats of many species. However, these relatively pristine, remote habitats are not expected to be immune to the effects of climate change. Thus, our analysis under Factor A focuses on the expected effects of climate change on meltwater lednian and western glacier stonefly habitat and populations.

    Climate Change

    Our analyses under the Endangered Species Act include consideration of ongoing and projected changes in climate. The terms “climate” and “climate change” are defined by the Intergovernmental Panel on Climate Change (IPCC). The term “climate” refers to the mean and variability of different types of weather conditions over time, with 30 years being a typical period for such measurements, although shorter or longer periods also may be used (IPCC 2014, pp. 119-120). The term “climate change” thus refers to a change in the mean or variability of one or more measures of climate (e.g., temperature or precipitation) that persists for an extended period, typically decades or longer, whether the change is due to natural variability, human activity, or both (IPCC 2014, p. 120).

    Scientific measurements spanning several decades demonstrate that changes in climate are occurring; since the 1950s many of the observed changes are unprecedented over decades to millennia (IPCC 2014, p. 40). Examples include warming of the global climate system, and substantial increases in precipitation in some regions of the world and decreases in other regions. (For these and other examples, see IPCC 2014, pp. 40-44; and Solomon et al. 2007, pp. 35-54, 82-85). Results of scientific analyses presented by the IPCC show that most of the observed increase in global average temperature since the mid-20th century cannot be explained by natural variability in climate, and is “extremely likely” (defined by the IPCC as 95 percent or higher probability) due to the observed increase in greenhouse gas (GHG) concentrations in the atmosphere as a result of human activities, particularly carbon dioxide emissions from use of fossil fuels (IPCC 2014, p. 48 and figures 1.9 and 1.10; Solomon et al. 2007, pp. 21-35).

    Scientists use a variety of climate models, which include consideration of natural processes and variability, as well as various scenarios of potential levels and timing of GHG emissions, to evaluate the causes of changes already observed and to project future changes in temperature and other climate conditions (e.g., Meehl et al. 2007, entire; Ganguly et al. 2009, pp. 11555, 15558; Prinn et al. 2011, pp. 527, 529). All combinations of models and emissions scenarios yield very similar projections of increases in the most common measure of climate change, average global surface temperature (commonly known as global warming), until about 2050 (IPCC 2014, p. 11; Ray et al. 2010, p. 11). Although projections of the magnitude and rate of warming differ after about 2050, the overall trajectory of all the projections is one of increased global warming through the end of this century, even for the projections based on scenarios that assume that GHG emissions will stabilize or decline. Thus, there is strong scientific support for projections that warming will continue through the 21st century, and that the magnitude and rate of change will be influenced substantially by the extent of GHG emissions (IPCC 2014, p. 57; Meehl et al. 2007, pp. 760-764 and 797-811; Ganguly et al. 2009, pp. 15555-15558; Prinn et al. 2011, pp. 527, 529). (See IPCC 2014, pp. 9-13, for a summary of other global projections of climate-related changes, such as frequency of heat waves and changes in precipitation.)

    Various changes in climate may have direct or indirect effects on species. These effects may be positive, neutral, or negative, and they may change over time, depending on the species and other relevant considerations, such as interactions of climate with other variables (e.g., habitat fragmentation) (IPCC 2014, pp. 6-7; 10-14). Identifying likely effects often involves aspects of climate change vulnerability analysis. Vulnerability refers to the degree to which a species (or system) is susceptible to, and unable to cope with, adverse effects of climate change, including climate variability and extremes. Vulnerability is a function of the type, magnitude, and rate of climate change and variation to which a species is exposed, its sensitivity, and its adaptive capacity (IPCC 2014, pp. 70, 72; see also Glick et al. 2011, pp. 19-22). There is no single method for conducting such analyses that applies to all situations (Glick et al. 2011, p. 3). We use our expert judgment and appropriate analytical approaches to weigh relevant information, including uncertainty, in our consideration of various aspects of climate change.

    As is the case with all stressors that we assess, even if we conclude that a species is currently affected or is likely to be affected in a negative way by one or more climate-related impacts, it does not necessarily follow that the species meets the definition of an “endangered species” or a “threatened species” under the Act. If a species is listed as endangered or threatened, knowledge regarding the vulnerability of the species to, and known or anticipated impacts from, climate-associated changes in environmental conditions can be used to help devise appropriate strategies for its recovery.

    Global climate projections are informative, and, in some cases, the only or the best scientific information available for us to use. However, projected changes in climate and related impacts can vary substantially across and within different regions of the world (e.g., IPCC 2014, pp. 12, 14). Therefore, we use “downscaled” projections when they are available and have been developed through appropriate scientific procedures, because such projections provide higher resolution information that is more relevant to spatial scales used for analyses of a given species (see Glick et al. 2011, pp. 58-61, for a discussion of downscaling). With regard to our analysis for the meltwater lednian stonefly and western glacier stonefly, downscaled projections are available.

    Regional climate—The western United States appears to be warming faster than the global average. In the Pacific Northwest, regionally averaged temperatures have risen 0.8 °C (1.5 °F) over the last century and as much as 2 °C (4 °F) in some areas. Since 1900, the mean annual air temperature for GNP and the surrounding region has increased 1.3 °C (2.3 °F), which is 1.8 times the global mean increase (U.S. Geological Survey (USGS) 2010, p. 1). Mean annual air temperatures are projected to increase by another 1.5 to 5.5 °C (3 to 10 °F) over the next 100 years (Karl et al. 2009, p. 135). Warming also appears to be pronounced in alpine regions globally (e.g., Hall and Fagre 2003, p. 134 and references therein). For the purposes of this finding, we consider the foreseeable future for anticipated effects of climate change on the alpine environment to be approximately 35 years (~year 2050) based on two factors. First, various global climate models (GCMs) and emissions scenarios provide consistent predictions within that timeframe (IPCC 2014, p. 11). Second, the effect of climate change on glaciers in GNP has been modeled within that timeframe (e.g., Hall and Fagre 2003, entire; Brown et al. 2010, entire).

    Habitats for both the meltwater lednian stonefly and the western glacier stonefly originate from meltwater sources that will be impacted by any projected warming, including glaciers and small icefields, permanent and seasonal snowpack, alpine springs, and glacial lake outlets (Hauer et al. 2007, p. 107; Giersch and Muhlfeld 2015, in progress). The alteration or loss of these meltwater sources and perennial habitat has direct consequences on both meltwater lednian stonefly and western glacier stonefly populations. Below, we provide an overview of expected rate of loss of meltwater sources in GNP as a result of climate change, followed by the predicted effects to stonefly habitat and populations from altered stream flows and water temperatures.

    Glacier loss—Glacier loss in GNP is directly influenced by climate change (e.g., Hall and Fagre 2003, entire; Fagre 2005, entire). When established in 1910, GNP contained approximately 150 glaciers larger than 0.1 square kilometer (25 acres) in size, but presently only 25 glaciers larger than this size remain (Fagre 2005, pp. 1-3; USGS 2005, 2010). Hall and Fagre (2003, entire) modeled the effects of climate change on glaciers in GNP's Blackfoot-Jackson basin using then-current climate assumptions (i.e., doubling of atmospheric carbon dioxide by 2030). Under this scenario, glaciers were predicted to completely melt in GNP by 2030, and predicted increases in winter precipitation due to climate change were not expected to buffer glacial shrinking (Hall and Fagre 2003, pp. 137-138). A more recent analysis of Sperry Glacier in GNP estimates this particular glacier may persist through 2080, in part due to annual avalanche inputs from an adjacent cirque wall (Brown et al. 2010, p. 5). We are not aware of any other published studies using more recent climate scenarios that speak directly to anticipated conditions of remaining glaciers in GNP. Thus, we largely rely on Hall and Fagre's 2003 predictions in our analysis, supplemented with more recent glacier-specific studies where appropriate (e.g., Brown et al. 2010, entire). However, we note that most climate scenarios developed since 2003 predict higher carbon dioxide concentrations (and thus greater warming and predicted effects) than those used in Hall and Fagre (2003).

    Loss of other meltwater sources—Meltwater in meltwater lednian stonefly and western glacier stonefly habitat is supplied by glaciers, as well as by four other sources: (1) Seasonal snow; (2) permanent snow; (3) alpine springs; and (4) ice masses (Giersch and Muhlfeld 2015, in progress). Seasonal snow is that which accumulates and melts seasonally, with the amount varying year to year depending on annual weather events. Permanent snow is some portion of a snowfield that does not generally melt on an annual basis, the volume of which can change over time. Alpine springs originate from some combination of meltwater from snow, ice masses or glaciers, and groundwater. Ice masses are smaller than glaciers and do not actively move as glaciers do.

    The sources of meltwater that supply meltwater lednian and western glacier stonefly habitat are expected to persist under a changing climate for varying durations. In general, we expect all meltwater sources to decline under a changing climate, given the relationship between climate and glacial melting (Hall and Fagre 2003, entire; Fagre 2005, entire) and recent climate observations and modeling (IPCC 2014, entire). It is likely that seasonal snowpack levels will be most immediately affected by climate change, as the frequency of more extreme weather events increases (IPCC 2014, p. 8). These extremes may result in increased seasonal snowpack in some years and reduced snowpack in others.

    It is also expected that permanent snowpack and ice masses will decline and completely melt within the near future. The timing of their disappearance is expected to be before the majority of glacial melting (i.e., 2030), because permanent snowpack and ice masses are less dense than glaciers and typically have smaller volumes of snow and ice. However, alpine springs, at least those supplemented with groundwater, may continue to be present after complete glacial melting. We discuss the probable effects of declining meltwater from all sources on meltwater lednian stonefly and western glacier stonefly habitat and populations in more detail below. Our analysis primarily focuses on effects to meltwater lednian stonefly and western glacier stonefly populations within GNP. However, effects to meltwater lednian stonefly populations south of GNP are expected to be similar in magnitude and will likely occur sooner in time than those discussed for GNP, because the glaciers and ice/snow fields feeding occupied meltwater stonefly habitat in those areas are smaller in size, and thus likely to melt sooner than those in GNP.

    Streamflows

    Meltwater streams—Declines in meltwater sources are expected to affect flows in meltwater streams in GNP. Glaciers and other meltwater sources act as water banks, whose continual melt maintains streamflows during late summer or drought periods (Hauer et al. 2007, p. 107). Following glacier loss, declines in streamflow and periodic dewatering events are expected to occur in meltwater streams in the northern Rocky Mountains (Hauer et al. 1997, p. 909). In similarly glaciated regions, intermittent stream flows have been documented following glacial recession and loss (Robinson et al. 2015, p. 8). By 2030, the modeled distribution of habitat with the highest likelihood of supporting meltwater lednian stonefly populations is predicted to decline by 81 percent in GNP, compared to present (Muhlfeld et al. 2011, p. 342). Desiccation (drying) of these habitats, even periodically, could eliminate entire populations of the meltwater lednian stonefly and the western glacier stonefly because nymphs need perennial flowing water to breathe and to mature before reproducing. Given that both stonefly species are believed to be poor dispersers, recolonization of previously occupied habitats is not expected following dewatering and extirpation events. Lack of recolonization by either stonefly species is expected to lead to further isolation between extant populations.

    Fifty-three (of 58) meltwater lednian stonefly populations and one (of four) western glacier stonefly population occupy habitats supplied by seasonal snowpack, permanent snowpack, and ice masses, and some glaciers. Meltwater from these sources is expected to become inconsistent by 2030 (Hall and Fagre 2003, p. 137; Giersch and Muhlfeld 2015, in progress). Although the rate at which flows will be reduced or at which dewatering events will occur in these habitats is unclear, we expect, at a minimum, to see decreases in abundance and distribution of both species in those populations. By 2030, the remaining populations are expected to be further isolated and occupying marginal habitat.

    Alpine springs—Declines in meltwater sources are also expected to affect flows in alpine springs, although likely on a longer time scale than for meltwater streams. Flow from alpine springs in the northern Rocky Mountains originates from glacial or snow meltwater in part, sometimes supplemented with groundwater (Hauer et al. 2007, p. 107). For this reason, some alpine springs are expected to be more climate-resilient and persist longer than meltwater streams and may serve as refugia areas for meltwater lednian and western glacier stoneflies, at least in the near-term (Ward 1994, p. 283). However, small aquifers feeding alpine springs are ultimately replenished by glacial and other meltwater sources in alpine environments (Hauer et al. 1997, p. 908).

    Once glaciers in GNP melt, small aquifer volumes and the groundwater influence they provide to alpine springs are expected to decline. Thus by 2030, even flows from alpine springs supplemented with groundwater are expected to decline (Hauer et al. 1997, p. 910). This expected pattern of decline is consistent with observed patterns of low flow from alpine springs in the Rocky mountain region and other glaciated regions during years with little snowpack (Hauer et al. 1997, p. 910; Robinson et al. 2015, p. 9). Further, following complete melting of glaciers, drying of alpine springs in GNP might be expected if annual precipitation fails to recharge groundwater supplies. Changes in future precipitation levels due to climate change in the GNP region are predicted to range from relatively unchanged to a small (~10 percent) annual increase (IPCC 2014, pp. 20-21).

    Only four populations of the meltwater lednian stonefly and two of the western glacier stonefly reside in streams originating from alpine springs. Thus, despite the potential for some alpine springs to provide refugia for both stonefly species even after glaciers melt, only a few populations may benefit from these potential refugia.

    Glacial lake outlets—Similar to alpine springs, flow from glacial lake outlets is expected to diminish gradually following the complete melting of most glaciers around 2030. Glacial lakes are expected to receive annual inflow from melting snow from the preceding winter, although the amount by which it may be reduced after complete glacial melting is unknown. Reductions in flow from glacial lakes are expected to, at a minimum, decrease the amount of available habitat for both meltwater lednian and western glacier stoneflies.

    One population each of the meltwater lednian stonefly and the western glacier stonefly occupies a glacial lake outlet (Upper Grinnell Lake; Giersch et al. 2015, p. 58, Giersch and Muhlfeld 2015, in progress). Thus, despite the fact that this habitat type may continue to provide refugia for both stonefly species even after the complete loss of glaciers, few populations may benefit from this potential refugia.

    As such, we conclude that habitat degradation in the form of reduced streamflows due to the effects of climate change is a threat to the persistence of 89 percent of meltwater lednian stonefly and 25 percent of western glacier stonefly populations now and into the future.

    Water Temperature

    Meltwater streams—Glaciers act as water banks, whose continual melting maintains suitable water temperatures for meltwater lednian stonefly and western glacier stonefly during late summer or drought periods (Hauer et al. 2007, p. 107; USGS 2010). As glaciers melt and contribute less volume of meltwater to streams, water temperatures are expected to rise (Hauer et al. 1997, p. 909). Aquatic invertebrates have specific temperature needs that influence their distribution (Fagre et al. 1997, p. 763; Lowe and Hauer 1999, pp. 1637, 1640, 1642; Hauer et al. 2007, p. 110); complete glacial melting may result in an increase in water temperatures above the physiological limits for survival or optimal growth for the meltwater lednian and western glacier stoneflies. As a result of melting glaciers and a lower volume of meltwater input into streams, we expect upward elevational shifts of meltwater lednian stonefly and western glacier stonefly populations, as they track their optimal thermal preferences. However, both meltwater lednian stonefly and western glacier stonefly already occupy the most upstream portions of these habitats and can move upstream only to the extent of the receding glacier/snowfield. Once the glaciers and snowfields completely melt, meltwater lednian stonefly and western glacier stonefly will have no physical habitat left to which to migrate upstream. The likely result of this scenario would be the extirpation of these populations. If meltwater from seasonal precipitation accumulation remained after the complete loss of glaciers, displacement or extirpation of populations of both stonefly species could still occur due to thermal conditions that become unsuitable, encroaching aquatic invertebrate species that may be superior competitors, or changed thermal conditions that may favor the encroaching species in competitive interactions between the species (condition-specific competition).

    The majority of meltwater lednian stonefly populations and one western glacier stonefly population occupy habitats that may warm significantly by 2030, due to the predicted complete melting of glaciers and snow/ice fields. Increasing water temperatures may be related to recent distributional declines of western glacier stoneflies within GNP (Giersch et al. 2015, p. 61). Thus, it is plausible that only those populations [6 meltwater lednian (11 percent of total known populations) and 3 western glacier stonefly (75 percent of total known populations)] occupying more climate-resilient habitat (e.g., springs, lake outlets, Sperry Glacier) may persist through 2030.

    Alpine springs—Although meltwater contributions to alpine springs are expected to decline as glaciers and permanent snow melt, water temperature at the springhead may remain relatively consistent due to the influence of groundwater, at least in the short term. The springhead itself may provide refugia for both meltwater lednian and western glacier stoneflies, although stream reaches below the actual springhead are expected to exhibit similar increases in water temperature in response to loss of glacial meltwater as those described for meltwater streams. However, as described above, some alpine springs may eventually dry up after glacier and snowpack loss, if annual precipitation fails to recharge groundwater supplies (Hauer et al. 1997, p. 910; Robinson et al. 2015, p. 9).

    Only four populations of the meltwater lednian stonefly (7 percent of total known populations) and two of the western glacier stonefly (50 percent of total known populations) reside in streams originating from alpine springs. Thus, despite the fact that alpine springs may be more thermally stable than meltwater streams and provide thermal refugia to both the meltwater lednian stonefly and the western glacier stonefly, only a few populations may benefit from this potential refugia.

    Glacial lake outlets—Similar to alpine springs, glacial lake outlets are more thermally stable habitats than meltwater streams. This situation is likely due to the buffering effect of large volumes of glacial lake water supplying these habitats. It is anticipated that the buffering effects of glacial lakes will continue to limit increases in water temperature to outlet stream habitats, even after loss of glaciers. However, water temperatures are still expected to increase over time following complete glacial loss in GNP. It is unknown whether water temperature increases in glacial lake outlets will exceed presumed temperature thresholds for meltwater lednian and western glacier stonefly in the near future. However, given the low water temperatures recorded in habitats where both species have been collected, even small increases in water temperature of glacial lake outlets may be biologically significant and detrimental to the persistence of both species.

    One population each of the meltwater lednian stonefly and the western glacier stonefly occupies a glacial lake outlet (Upper Grinnell Lake; Giersch et al. 2015, p. 58, Giersch and Muhlfeld 2015, in progress). Thus, despite the fact that glacial lake outlets may be more thermally stable than meltwater streams and provide thermal refugia to both the meltwater lednian stonefly and the western glacier stonefly, a small percentage of the overall population of each species may benefit from these potential refugia. Consequently, we conclude that changes in water temperature from climate change are a threat to most populations of both stonefly species now and into the future.

    Maintenance and Improvement of Glacier National Park Infrastructure

    Glacier National Park is managed to protect natural and cultural resources, and the landscape within the park is relatively pristine. However, the GNP does include a number of human-built facilities and structures that support visitor services, recreation, and access, such as the Going-to-the-Sun Road (which bisects GNP) and numerous visitor centers, trailheads, overlooks, and lodges (e.g., NPS 2003a, pp. S3, 11). Maintenance and improvement of these facilities and structures could conceivably lead to disturbance of the natural environment.

    We are aware of one water diversion on Logan Creek that supplies water to the Logan Pass Visitor Center. This diversion is located several feet under the streambed in a segment of Logan Creek in which meltwater lednian stonefly is found. While the diversion has been operated for decades, recent surveys indicate relatively high densities of meltwater lednian stonefly in Logan Creek, particularly upstream of the diversion (NPS 2009, entire; Giersch 2016, pers. comm.). The diversion is scheduled to be retrofitted in 2017, in part to decrease instream withdrawals and increase efficiency. The diversion retrofit will likely include dewatering a short section of stream surrounding the intake structure, by diverting streamflow around the construction site. Minimization measures expected to be implemented as part of the diversion retrofit include relocation of meltwater lednian stoneflies out of the construction zone and using appropriate sedimentation control measures. Given the recent survey information indicating high densities of meltwater lednian stonefly in Logan Creek and the use of appropriate minimization measures, we have no evidence that the existing water diversion or retrofit project are a threat to meltwater lednian stonefly at the population level.

    We do not have any information indicating that maintenance and improvement of other GNP facilities and structures is affecting either meltwater lednian or western glacier stoneflies or their habitat. While roads and trails provide avenues for recreationists (primarily hikers) to access backcountry areas, most habitats for both the meltwater lednian stonefly and the western glacier stonefly are located in steep, rocky areas that are not easily accessible, even from backcountry trails. Most documented occurrences of both species are in remote locations upstream from human-built structures, thereby precluding any impacts to stonefly habitat from maintenance or improvement of these structures. Given the above information, we conclude that maintenance and improvement of GNP facilities and structures, and the resulting improved access into the backcountry for recreationists, does not constitute a threat to the meltwater lednian or western glacier stonefly or their habitat now or in the near future.

    Glacier National Park Visitor Impacts

    In 2015, GNP hosted 2.3 million visitors (NPS 2015). Many of the recent collection sites for the meltwater lednian stonefly (e.g., Logan and Reynolds Creeks) are near visitor centers or adjacent to popular hiking trails. Theoretically, human activity (wading) in streams by anglers or hikers could disturb meltwater lednian stonefly habitat. However, we consider it unlikely that many GNP visitors would actually wade in stream habitats where the species has been collected, because the sites are in small, high-elevation streams situated in rugged terrain, and most would not be suitable for angling due to the absence of fish. In addition, the sites are typically snow covered into late July or August (Giersch 2010a, pers. comm.), making them accessible for only a few months annually. We also note that the most accessible collection sites in Logan Creek near the Logan Pass Visitor Center and the Going-to-the-Sun Road are currently closed to public use and entry to protect resident vegetation (NPS 2010, pp. J5, J24). We conclude that impacts to the meltwater lednian and western glacier stonefly and their habitat from visitors to GNP do not constitute a threat now or in the near future.

    Wilderness Area Visitor Impacts

    Three populations of meltwater lednian stonefly are located in wilderness areas adjacent to GNP. Visitor activities in wilderness areas are similar to those described for GNP, namely hiking and angling. No recreational hiking trails are present near the two populations of meltwater lednian stonefly in the Bob Marshall wilderness and Great Bear wilderness (USFS 2015, p. 1) or near the population occurring in the Mission Mountain Tribal Wilderness. Similar to GNP, stream reaches that harbor the meltwater lednian stonefly in these wilderness areas are fishless, so wade anglers are not expected to disturb stonefly habitat. Given the remote nature of and limited access to meltwater stonefly habitat in wilderness areas adjacent to GNP, we do not anticipate any current or future threats to meltwater lednian stoneflies or their habitat from visitor use.

    Summary of Factor A

    In summary, we expect climate change to fragment or degrade all habitat types that are currently occupied by meltwater lednian and western glacier stoneflies, albeit at different rates. Flows in meltwater streams are expected to be affected first, by becoming periodically intermittent and warmer. Drying of meltwater streams and water temperature increases, even periodically, are expected to reduce available habitat for the meltwater lednian stonefly by 81 percent by 2030. After 2030, flow reductions and water temperature increases due to continued warming are expected to further reduce or degrade remaining refugia habitat (alpine springs and glacial lake outlets) for both meltwater lednian and western glacier stoneflies. Predicted habitat changes are based on observed patterns of flow and water temperature in similar watersheds within GNP and elsewhere where glaciers have already melted.

    In addition, we have observed a declining trend in western glacier stonefly distribution over the last 50 years, as air temperatures have warmed in GNP. We expect the meltwater lednian stonefly to follow a similar trajectory, given the similarities between the two stonefly species and their meltwater habitats. Consequently, we conclude that habitat fragmentation and degradation resulting from climate change is a threat to both the meltwater lednian and western glacier stoneflies now and into the near future. Given the minimal overlap between stonefly habitat and most existing infrastructure or backcountry activities (e.g., hiking), we conclude any impacts from these activities do not constitute a threat to either the meltwater lednian stonefly or the western glacier stonefly. The sole water diversion present on Logan Creek and the upcoming retrofit project also do not appear to be threats to meltwater lednian stonefly, given that recent surveys have documented high densities of meltwater lednian stonefly near the diversion, and the expected use of appropriate minimization measures for the retrofit project.

    Factor B. Overutilization for Commercial, Recreational, Scientific, or Educational Purposes

    We are not aware of any threats involving the overutilization or collection of the meltwater lednian or western glacier stonefly for any commercial, recreational, or educational purposes at this time. We are aware that specimens of both species are occasionally collected for scientific purposes to determine their distribution and abundance (e.g., Baumann and Stewart 1980, pp. 655, 658; NPS 2009; Muhlfeld et al. 2011, entire; Giersch et al. 2015, entire). However both species are comparatively abundant in remaining habitats (e.g., NPS 2009; Giersch 2016, pers. comm.), and we have no information to suggest that past, current, or any collections in the near future will result in population-level effects to either species. Consequently, we do not consider overutilization for commercial, recreational, scientific, or educational purposes to be a threat to the meltwater lednian or western glacier stonefly now or in the near future.

    Factor C. Disease or Predation

    We are not aware of any diseases that affect the meltwater lednian or western glacier stonefly. Therefore, we do not consider disease to be a threat to these species now or in the near future.

    We presume that nymph and adult meltwater lednian and western glacier stoneflies may occasionally be subject to predation by bird species such as American dipper (Cinclus mexicanus) or predatory aquatic insects. Fish and amphibians are not potential predators because these species do not occur in the stream reaches containing the meltwater lednian stonefly and the western glacier stonefly. The American dipper prefers to feed on aquatic invertebrates in fast-moving, clear alpine streams (MNHP 2010b), and the species is native to GNP. As such, predation by American dipper on these species would represent a natural ecological interaction in the GNP (see Synergistic Effects section below for analysis on potential predation/habitat fragmentation synergy). Similarly, predation by other aquatic insects would represent a natural ecological interaction between the species. We have no evidence that the extent of such predation, if it occurs, represents any population-level threat to either meltwater lednian or western glacier stonefly, especially given that densities of individuals within many of these populations are high. Therefore, we do not consider predation to be a threat to these species now or in the near future.

    In summary, the best available scientific and commercial information does not indicate that the meltwater lednian or western glacier stonefly is affected by any diseases, or that natural predation occurs at levels likely to negatively affect either species at the population level. Therefore, we do not find disease or predation to be threats to the meltwater lednian or western glacier stonefly now or in the near future.

    Factor D. The Inadequacy of Existing Regulatory Mechanisms

    Section 4(b)(1)(A) of the Endangered Species Act requires the Service to take into account “those efforts, if any, being made by any State or foreign nation, or any political subdivision of a State or foreign nation, to protect such species....” We consider relevant Federal, State, and Tribal laws and regulations when evaluating the status of the species. Only existing ordinances, regulations, and laws that have a direct connection to a law are enforceable and permitted are discussed in this section. No local, State, or Federal laws specifically protect the meltwater lednian or western glacier stonefly.

    National Environmental Policy Act

    All Federal agencies are required to adhere to the National Environmental Policy Act (NEPA) of 1970 (42 U.S.C. 4321 et seq.) for projects they fund, authorize, or carry out. NEPA is a procedural statute, which requires Federal agencies to formally document and publicly disclose the environmental impacts of their actions and management decisions. Documentation for NEPA is provided in an environmental impact statement, an environmental assessment, or a categorical exclusion. NEPA does not require that adverse impacts be mitigated. Our review finds that it is likely that there would be very few activities that would trigger NEPA's disclosure requirements. However, NEPA does not require protection of a species or its habitat, and does not require the selection of a particular course of action.

    National Park Service Organic Act

    The NPS Organic Act of 1916 54 U.S.C. 100101 (et seq.), as amended, states that the NPS “shall promote and regulate the use of the National Park System by means and measures that conform to the fundamental purpose of the System units, which purpose is to conserve the scenery, natural and historic objects, and wild life in the System units and to provide for the enjoyment of the scenery, natural and historic objects, and wild life in such manner and by such means as will leave them unimpaired for the enjoyment of future generations.” Given that the vast majority of occurrences of the meltwater lednian stonefly (>90 percent) and all occurrences of the western glacier stonefly are within the boundaries of GNP, the NPS Organic Act is one Federal law of particular relevance to both species. Although the GNP does not have a management plan specific to either stonefly species, the habitats occupied by the species remain relatively pristine and generally free from direct human impacts from Park visitors (see Threat Factor A). We also note that the most accessible meltwater lednian stonefly collection sites in Logan Creek near the Logan Pass Visitor Center and the Going-to-the-Sun Road are currently closed to public use and entry to protect resident vegetation pursuant to GNP management regulations (NPS 2010, pp. J5, J24).

    Regulatory Mechanisms To Limit Glacier Loss

    National and international regulatory mechanisms to comprehensively address the causes of climate change are continuing to be developed. Domestic U.S. efforts relative to climate change focus on implementation of the Clean Air Act, and continued studies, programs, support for developing new technologies, and use of incentives for supporting reductions in emissions. While not regulatory, international efforts to address climate change globally began with the United Nations Framework Convention on Climate Change (UNFCCC), adopted in May 1992. The stated objective of the UNFCCC is the stabilization of GHG concentrations in the atmosphere at a level that would prevent dangerous anthropogenic interference with the climate system. However, we note that greenhouse gas loading in the atmosphere can have a considerable lag effect on climate, so that what has already been emitted will have impacts out to 2100 and beyond (IPCC 2014, pp. 56-57).

    National Forest Management Act

    The National Forest Management Act (NFMA; 16 U.S.C. 1600-1614, as amended) requires the Secretary of the Department of Agriculture to develop and implement resource management plans for each unit of the National Forest System. The Forest Service has developed a land management plan for the Flathead National Forest, including the wilderness portions containing meltwater stonefly populations, that designates conservation of sensitive, endangered and threatened species as a high priority (USFS 2001, p. III-109). In addition, only natural agents (fire, wind, insects, etc.) are permitted to alter the vegetation or habitat within the wilderness portions of the Flathead National Forest (USFS 2001, p. III-109). As such, the wilderness areas on Flathead National Forest are managed for natural ecological processes to maintain wilderness character.

    Wilderness Act

    The Wilderness Act of 1964 (16 U.S.C. 1131-1136, 78 Stat. 890) provides that areas designated by Congress as “wilderness areas” “shall be administered for the use and enjoyment of the American people in such manner as will leave them unimpaired for future use and enjoyment as wilderness. . . .” The Act also directed the Secretary of the Interior to review and make recommendations to the President about the suitability of particular lands for preservation as wilderness, with the final decision being made by Congress (16 U.S.C. 1132(c)). These lands are managed under the nonimpairment standard to ensure that they retain their wilderness character until Congress makes a decision. Areas where the meltwater lednian stonefly occurs within Flathead National Forest are designated as wilderness. Areas where the meltwater lednian and western glacier stoneflies occur within GNP were nominated for protection as wilderness in 1974, but Congress has not rendered a decision. Pursuant to NPS policy, the proposed wilderness lands are managed as wilderness (NPS Management Policy § 6.3 (2006)).

    The Wilderness Act establishes restrictions on land use activities that can be undertaken on a designated area. In particular, such lands are managed to preserve their wilderness character, and many activities that might otherwise be permitted are prohibited on lands designated as wilderness (e.g., commercial enterprise, roads, logging, mining, oil/gas exploration) (16 U.S.C. 1133(c)).

    Flathead Indian Reservation Fishing, Bird Hunting, and Recreation Regulations

    The Confederated Kootenai Salish Tribes manage land on the Flathead Reservation and are currently implementing “Flathead Indian Reservation Fishing, Bird Hunting, and Recreation Regulations,” which, in part, regulate recreation in the Mission Mountain Tribal Wilderness Area (MMTW), where one population of the meltwater lednian stonefly occurs. Some relevant regulations preclude the removal of natural items from the MMTW and restrict certain activities within 30 m (100 ft) of water sources.

    Factor E. Other Natural or Manmade Factors Affecting Its Continued Existence Small Population Size

    A principle of conservation biology is that the presence of larger and more productive (resilient) populations can reduce overall extinction risk. To minimize extinction risk, genetic diversity should be maintained (Fausch et al. 2006, p. 23; Allendorf et al. 1997, entire). Both meltwater lednian and western glacier stonefly populations exist as presumably isolated populations, given that most populations are separated by considerable distances (i.e., miles) and stoneflies in general are poor dispersers (on the order of tens of meters). Population isolation can limit or preclude genetic exchange between populations (Fausch et al. 2006, p. 8). However, densities within many of these populations are high (Giersch 2016, pers. comm.), which may offset or delay, at least in part, deleterious genetic effects from population isolation. Given the lack of genetic information for both meltwater lednian and western glacier stonefly, and the relatively high densities observed in many of the populations, we conclude that the effects of small population size (as a standalone issue) is not a threat now or in the near future.

    Restricted Range and Stochastic (Random) Events

    Narrow endemic species, such as the meltwater lednian stonefly and the western glacier stonefly, can be at risk of extirpation from random events such as fire, flooding, or drought. Random events occurring within the narrow range of endemic species have the potential to disproportionately affect large numbers of individuals or populations, relative to a more widely dispersed species. The risk to meltwater lednian and western glacier stonefly populations from fire appears low, given that most alpine environments in GNP have few trees and little vegetation to burn. The risk to both species from flooding also appears low, given the relatively small watershed areas available to capture and channel precipitation upslope of most stonefly populations.

    The risk to the meltwater lednian stonefly from drought appears moderate in the near term because 20 of the 58 known populations occupy habitats supplied by seasonal snowmelt, which would be expected to decline during drought. For the western glacier stonefly, the threat of drought is also moderate because one of the four known populations is likely to be affected by variations in seasonal precipitation and snowpack. The risk of drought in the longer term (after 2030 and when complete loss of glaciers is predicted) appears high for both stonefly species. Once glaciers melt, drought or extended drought could result in dewatering events in some habitats. Dewatering events would likely extirpate entire populations almost instantaneously. Natural recolonization of habitats affected by drought is unlikely, given the poor dispersal abilities of both stonefly species and general isolation of populations relative to one another (Hauer et al. 2007, pp. 108-110). Thus, we conclude that drought (a stochastic event) will be a threat to both the meltwater lednian stonefly and the western glacier stonefly in the near future.

    Summary of Factor E

    The effect of small population size does not appear to be a current or future threat to the meltwater lednian stonefly or the western glacier stonefly, given the high densities of individuals within most populations. However, the restricted range of the meltwater lednian and western glacier stonefly make both species vulnerable to the stochastic threat of drought. Although not considered a current threat, drought will likely affect both species negatively within the near future. There is potential for extirpation of entire populations of both species as a result of dewatering events caused by drought, after the complete loss of glaciers predicted by 2030. Thus, drought is considered a threat to both the meltwater lednian stonefly and the western glacier stonefly within the near future.

    Synergistic Effects

    Climate change may interact with other potential stressors and compound negative effects on meltwater lednian stonefly and western glacier stonefly populations. We limit our discussion here to factors that are not implicitly linked, and whose effects are not accounted for, in our previous analysis regarding climate change.

    Climate Change and Predation

    Previously, we presumed that nymph and adult meltwater lednian and western glacier stoneflies may occasionally be subject to predation by bird species such as American dipper or predatory aquatic insects. As such, predation by American dipper or predatory aquatic insects on these species would represent a natural ecological interaction in the GNP and surrounding areas. However, habitat fragmentation and degradation resulting from climate change may create different scenarios where populations of the meltwater lednian stonefly and the western glacier stonefly remain in isolated pockets of habitat, in thermally marginal habitat, or both, and are exposed to relative increased levels of predation. In such cases, the ability of the meltwater lednian stonefly or the western glacier stonefly to persist could theoretically be compromised by the cumulative effects resulting from the two pressures acting synergistically. Below, we evaluate the possibility of these scenarios in more detail.

    In the first scenario, the meltwater lednian stonefly or the western glacier stonefly may occupy small, isolated pockets (or pools) of habitat resulting from fragmentation (e.g., springheads). Under this scenario, predation from both American dippers and aquatic predatory insects could result in population-level effects of either species in these habitats. However, this situation appears unlikely for several reasons. First, the microhabitat features (rocks, bark) present that allow the meltwater lednian stonefly and the western glacier stonefly to evade predation would likely still be present, albeit in smaller quantities. Thus, even with increased predation pressure within a confined stream pool, both species would likely still utilize available habitat features to survive and fulfill life-history needs. Second, assuming thermal regimes are still within physiological limits, both stonefly species would likely use the same behavioral strategies they currently use to persist (e.g., timing of foraging, resting, and reproducing). In this scenario, population densities could potentially be reduced beyond what would be expected in more contiguous habitat, but population-level effects from predation appear unlikely, especially given the high densities of individuals within many of these populations.

    In a second scenario, physical habitat extent may remain intact, but thermal conditions may be altered (e.g., water temperature has increased significantly). In this case, increased water temperatures may interfere with the ability of the meltwater lednian stonefly or the western glacier stonefly to rely on behavioral strategies to evade predation effectively. Individuals may be forced to forage or move at inopportune times, resulting in higher predation levels and likely lower reproductive success. However, increases in water temperature may also affect the behavioral strategies (foraging) of aquatic predatory insects similar to that of the meltwater lednian and western glacier stonefly. It appears unlikely that the predatory abilities of American dipper would be affected by increased water temperature. However, it is unclear how efficient American dippers are as stonefly predators and whether they could exert enough predation pressure to rise to a population-level effect for the meltwater lednian and western glacier stonefly.

    If both fragmented habitat and thermally modified habitat are present in tandem, the resulting effects of predation would likely be greater than those described for either previous scenario. The intensity of predation would be expected to increase as a result of more fragmented habitat, and from behavioral changes potentially increasing the vulnerability of meltwater lednian and western glacier stoneflies to predators. Mortality of individual stoneflies would likely be higher in this scenario than for either previous scenario. However, it is still unclear what the effects of increased water temperatures would be on aquatic predators and whether the efficiency of avian predators would increase to the point where a population-level effect would be observed in meltwater lednian stonefly or western glacier stonefly populations. While the narrow range of the species and the small areas they inhabit make entire populations vulnerable to extirpation due to the effects of climate change, the high densities of individuals found within many of these populations make the effects of predation less likely to have population-level impacts. Therefore, cumulative effects resulting from climate change and predation are not considered a threat to any population of meltwater lednian and western glacier stoneflies now or in the near future.

    Climate Change, Habitat Fragmentation, Stochastic Events, and Small Population Size

    Meltwater habitats used by meltwater lednian stonefly and western glacier stonefly are expected to become increasingly fragmented due to climate change. One consequence of increasing habitat fragmentation is increasing isolation of existing stonefly populations, relative to one another. As isolation among stonefly populations increases, smaller populations may become more vulnerable to extirpation due to stochastic events such as drought. In the event of local extirpations from stochastic events, recolonization of previously occupied habitat appears unlikely, given the poor dispersal capabilities of stoneflies and isolation of populations in increasingly fragmented habitat. However, while interactions between and among these factors are likely, it appears more evident that habitat degradation in the form of reduced flows and increased water temperatures will play a larger and more immediate role in determining the persistence of meltwater lednian and western glacier stonefly populations. With the potential to extirpate entire populations almost instantaneously, dewatering events resulting from loss of meltwater sources is likely to be the primary driver affecting populations of both stonefly species in the near future. While the interactions between climate change, habitat fragmentation, stochastic events, and small population size are likely to occur, the timescale at which we would expect population-level threats to occur is far beyond the timescale that habitat degradation (dewatering in particular) is expected to act on both species at the population level. Thus, at this time, we do not consider the interactions between and among climate change, habitat fragmentation, stochastic events, and small population size to be a threat.

    Determination

    Section 4 of the Act (16 U.S.C. 1533), and its implementing regulations at 50 CFR part 424, set forth the procedures for adding species to the Federal Lists of Endangered and Threatened Wildlife and Plants. Under section 4(a)(1) of the Act, we may list a species based on (A) The present or threatened destruction, modification, or curtailment of its habitat or range; (B) Overutilization for commercial, recreational, scientific, or educational purposes; (C) Disease or predation; (D) The inadequacy of existing regulatory mechanisms; or (E) Other natural or manmade factors affecting its continued existence. Listing actions may be warranted based on any of the above threat factors, singly or in combination.

    We have carefully assessed the best scientific and commercial information available regarding the past, present, and future threats to the meltwater lednian stonefly and the western glacier stonefly. Habitat fragmentation and degradation in the form of declining streamflows and increasing water temperatures resulting from climate change are currently affecting habitat for the meltwater lednian stonefly and the western glacier stonefly (Factor A). Habitat with a high probability of occupancy for the meltwater lednian stonefly is modeled to decrease 81 percent by 2030 (Muhlfeld et al. 2011, p. 342). Due to the anticipated near-term reduction of meltwater from seasonal snowpack and future reduction of flow from other meltwater sources in the foreseeable future, drought is expected to affect meltwater lednian stonefly and western glacier stonefly populations occupying habitat supplied by those meltwater sources (Factor E). As a result of this anticipated loss of habitat and populations, only a few refugia populations are expected to persist in the longer term. Recolonization of habitats where known populations of either species are extirpated is not anticipated, given the poor dispersal abilities of both species. Threats to meltwater lednian stonefly and western glacier stonefly habitat are currently occurring rangewide and are expected to continue into the foreseeable future.

    The Act defines an endangered species as any species that is “in danger of extinction throughout all or a significant portion of its range” and a threatened species as any species “that is likely to become endangered throughout all or a significant portion of its range within the foreseeable future.” We find that the meltwater lednian stonefly is likely to become endangered throughout all or a significant portion of its range within the foreseeable future.

    The meltwater lednian stonefly occupies a relatively narrow range of alpine habitats that are expected to become fragmented and degraded by climate change. Meltwater lednian stonefly habitat and populations are threatened by several factors that are expected to reduce the overall viability of the species. Therefore, on the basis of the best available scientific and commercial information, we propose listing the meltwater lednian stonefly as threatened in accordance with sections 3(6) and 4(a)(1) of the Act. We find that an endangered species status is not appropriate for the meltwater lednian stonefly because the species is not currently in danger of extinction because it faces relatively low near-term risk of extinction. Although the effects of climate change and drought are currently affecting, and expected to continue affecting, the alpine habitats occupied by the meltwater lednian stonefly, meltwater sources are expected to persist in the form of alpine springs and glacial lake outlets after the predicted melting of most glaciers in GNP by 2030. Densities and estimated abundance of the meltwater lednian stonefly are currently relatively high. In addition, some meltwater lednian stonefly populations continue to persist in meltwater habitats supplied by seasonal snowpack. These findings suggest that as climate change continues to impact stonefly habitat, some populations will likely persist in refugia areas at least through the foreseeable future. Thus, we find that the definition of threatened better characterizes the current status of the meltwater lednian stonefly and the likelihood that they will become in danger of extinction in the foreseeable future.

    We also find that the western glacier stonefly is likely to become endangered throughout all or a significant portion of its range within the foreseeable future. Similar to meltwater lednian stonefly, the western glacier stonefly occupies a relatively narrow range of alpine habitats that are expected to become fragmented and degraded by climate change. Western glacier stonefly habitat and populations are threatened by several factors that are expected to reduce the overall viability of the species. Therefore, on the basis of the best available scientific and commercial information, we propose listing the western glacier stonefly as threatened in accordance with sections 3(6) and 4(a)(1) of the Act. We find that an endangered species status is not appropriate for the western glacier stonefly because the species is not currently in danger of extinction because it faces relatively low near-term risk of extinction. Although the effects of climate change and drought are currently affecting, and expected to continue affecting, the alpine habitats occupied by the western glacier stonefly, meltwater sources are expected to persist in the form of alpine springs and glacial lake outlets after the predicted melting of most glaciers in GNP by 2030. Although only four populations of western glacier stonefly are known, densities and estimated abundance of the western glacier stonefly within those populations are currently relatively high. These findings suggest that as climate change continues to impact stonefly habitat, some populations will likely persist in refugia areas at least through the foreseeable future. Thus, we find that the definition of threatened better characterizes the current status of the western glacier stonefly and the likelihood that they will become in danger of extinction in the foreseeable future.

    Under the Act and our implementing regulations, a species may warrant listing if it is endangered or threatened throughout all or a significant portion of its range. Because we have determined that the meltwater lednian stonefly and the western glacier stonefly are threatened throughout all of their range, no portion of their range can be “significant” for purposes of the definitions of “endangered species” and “threatened species.” A detailed explanation of “significance” is included in our Final Policy on Interpretation of the Phrase “Significant Portion of Its Range” in the Endangered Species Act's Definitions of “Endangered Species” and “Threatened Species” (79 FR 37577, July 1, 2014).

    Available Conservation Measures

    Conservation measures provided to species listed as endangered or threatened species under the Act include recognition, recovery actions, requirements for Federal protection, and prohibitions against certain practices. Recognition through listing results in public awareness, and conservation by Federal, State, Tribal, and local agencies, private organizations, and individuals. The Act encourages cooperation with the States and other countries and calls for recovery actions to be carried out for listed species. The protection required by Federal agencies and the prohibitions against certain activities are discussed, in part, below.

    The primary purpose of the Act is the conservation of endangered and threatened species and the ecosystems upon which they depend. The ultimate goal of such conservation efforts is the recovery of these listed species, so that they no longer need the protective measures of the Act. Subsection 4(f) of the Act calls for the Service to develop and implement recovery plans for the conservation of endangered and threatened species. The recovery planning process involves the identification of actions that are necessary to halt or reverse the species' decline by addressing the threats to its survival and recovery. The goal of this process is to restore listed species to a point where they are secure, self-sustaining, and functioning components of their ecosystems.

    Recovery planning includes the development of a recovery outline shortly after a species is listed and preparation of a draft and final recovery plan. The recovery outline guides the immediate implementation of urgent recovery actions and describes the process to be used to develop a recovery plan. Revisions of the plan may be done to address continuing or new threats to the species, as new substantive information becomes available. The recovery plan also identifies recovery criteria for review of when a species may be ready for downlisting or delisting, and methods for monitoring recovery progress. Recovery plans also establish a framework for agencies to coordinate their recovery efforts and provide estimates of the cost of implementing recovery tasks. Recovery teams (composed of species experts, Federal and State agencies, nongovernmental organizations, and stakeholders) are often established to develop recovery plans. When completed, the recovery outline, draft recovery plan, and the final recovery plan will be available on our Web site (http://www.fws.gov/endangered), or from our Montana Ecological Services Field Office (see FOR FURTHER INFORMATION CONTACT).

    Implementation of recovery actions generally requires the participation of a broad range of partners, including other Federal agencies, States, Tribes, nongovernmental organizations, businesses, and private landowners. Examples of recovery actions include habitat restoration (e.g., restoration of native vegetation), research, captive propagation and reintroduction, and outreach and education. The recovery of many listed species cannot be accomplished solely on Federal lands because their range may occur primarily or solely on non-Federal lands. To achieve recovery of these species requires cooperative conservation efforts on private, State, and Tribal lands. If these species are listed, funding for recovery actions will be available from a variety of sources, including Federal budgets, State programs, and cost-share grants for non-Federal landowners, the academic community, and nongovernmental organizations. In addition, pursuant to section 6 of the Act, the State of Montana would be eligible for Federal funds to implement management actions that promote the protection or recovery of the meltwater lednian stonefly and the western glacier stonefly. Information on our grant programs that are available to aid species recovery can be found at: http://www.fws.gov/grants.

    Although the meltwater lednian and the western glacier stonefly are only proposed for listing under the Act at this time, please let us know if you are interested in participating in recovery efforts for these species. Additionally, we invite you to submit any new information on these species whenever it becomes available and any information you may have for recovery planning purposes (see FOR FURTHER INFORMATION CONTACT).

    Section 7(a) of the Act requires Federal agencies to evaluate their actions with respect to any species that is proposed or listed as an endangered or threatened species and with respect to its critical habitat, if any is designated. Regulations implementing this interagency cooperation provision of the Act are codified at 50 CFR part 402. Section 7(a)(4) of the Act requires Federal agencies to confer with the Service on any action that is likely to jeopardize the continued existence of a species proposed for listing or result in destruction or adverse modification of proposed critical habitat. If a species is listed subsequently, section 7(a)(2) of the Act requires Federal agencies to ensure that activities they authorize, fund, or carry out are not likely to jeopardize the continued existence of the species or destroy or adversely modify its critical habitat. If a Federal action may affect a listed species or its critical habitat, the responsible Federal agency must enter into consultation with the Service.

    Federal agency actions within the species' habitat that may require conference or consultation or both as described in the preceding paragraph include management, any other landscape-altering activities, or research permit applications on Federal lands administered by the National Park Service and U.S. Forest Service.

    Under section 4(d) of the Act, the Service has discretion to issue regulations that we find necessary and advisable to provide for the conservation of threatened species. The Act and its implementing regulations set forth a series of general prohibitions and exceptions that apply to threatened wildlife. The prohibitions of section 9(a)(1) of the Act, as applied to threatened wildlife and codified at 50 CFR 17.31, make it illegal for any person subject to the jurisdiction of the United States to take (which includes harass, harm, pursue, hunt, shoot, wound, kill, trap, capture, or collect; or to attempt any of these) threatened wildlife within the United States or on the high seas. In addition, it is unlawful to import; export; deliver, receive, carry, transport, or ship in interstate or foreign commerce in the course of commercial activity; or sell or offer for sale in interstate or foreign commerce any listed species. It is also illegal to possess, sell, deliver, carry, transport, or ship any such wildlife that has been taken illegally. Certain exceptions apply to employees of the Service, the National Marine Fisheries Service, other Federal land management agencies, and State conservation agencies.

    We may issue permits to carry out otherwise prohibited activities involving threatened wildlife under certain circumstances. Regulations governing permits are codified at 50 CFR 17.32. With regard to threatened wildlife, a permit may be issued for the following purposes: for scientific purposes, to enhance the propagation or survival of the species, and for incidental take in connection with otherwise lawful activities. There are also certain statutory exemptions from the prohibitions, which are found in sections 9 and 10 of the Act.

    It is our policy, as published in the Federal Register on July 1, 1994 (59 FR 34272), to identify to the maximum extent practicable at the time a species is listed, those activities that would or would not constitute a violation of section 9 of the Act. The intent of this policy is to increase public awareness of the effect of a proposed listing on proposed and ongoing activities within the range of the species proposed for listing.

    Based on the best available information, the following activities may potentially result in a violation of section 9 of the Act; this list is not comprehensive:

    (1) Unauthorized handling or collecting of the species;

    (2) Destruction/alteration of the species' habitat, whether aquatic or riparian.

    Questions regarding whether specific activities would constitute a violation of section 9 of the Act should be directed to the Montana Ecological Services Field Office (see FOR FURTHER INFORMATION CONTACT).

    Critical Habitat

    Critical habitat is defined in section 3 of the Act as:

    (1) The specific areas within the geographical area occupied by the species, at the time it is listed in accordance with the Act, on which are found those physical or biological features

    (a) Essential to the conservation of the species, and

    (b) Which may require special management considerations or protection; and

    (2) Specific areas outside the geographical area occupied by the species at the time it is listed, upon a determination that such areas are essential for the conservation of the species.

    Our regulations at 50 CFR 424.02 define the geographical area occupied by the species as: An area that may generally be delineated around species' occurrences, as determined by the Secretary (i.e., range). Such areas may include those areas used throughout all or part of the species' life cycle, even if not used on a regular basis (e.g., migratory corridors, seasonal habitats, and habitats used periodically but not solely by vagrant individuals).

    Conservation, as defined under section 3 of the Act, means to use and the use of all methods and procedures that are necessary to bring an endangered or threatened species to the point at which the measures provided pursuant to the Act are no longer necessary. Such methods and procedures include, but are not limited to, all activities associated with scientific resources management such as research, census, law enforcement, habitat acquisition and maintenance, propagation, live trapping, and transplantation, and, in the extraordinary case where population pressures within a given ecosystem cannot be otherwise relieved, may include regulated taking.

    Prudency Determination

    Section 4(a)(3) of the Act, as amended, and implementing regulations (50 CFR 424.12), require that, to the maximum extent prudent and determinable, the Secretary shall designate critical habitat at the time the species is determined to be an endangered or threatened species. Our regulations (50 CFR 424.12(a)(1)) state that the designation of critical habitat is not prudent when one or both of the following situations exist:

    (1) The species is threatened by taking or other human activity, and identification of critical habitat can be expected to increase the degree of threat to the species, or

    (2) such designation of critical habitat would not be beneficial to the species. In determining whether a designation would not be beneficial, the factors the Service may consider include but are not limited to: Whether the present or threatened destruction, modification, or curtailment of a species' habitat or range is not a threat to the species, or whether any areas meet the definition of “critical habitat.”

    As discussed above, there is currently no imminent threat of take attributed to collection or vandalism identified under Factor B for this species, and identification and mapping of critical habitat is not expected to initiate any such threat. In the absence of finding that the designation of critical habitat would increase threats to a species, we next determine whether such designation of critical habitat would not be beneficial to the species. In our analysis above, we determined that there are habitat-based threats to the meltwater lednian stonefly and the western glacier stonefly identified under Factor A. Therefore, we find that the designation of critical habitat would be beneficial to the meltwater lednian stonefly and the western glacier stonefly through the provisions of section 7 of the Act. Because we have determined that the designation of critical habitat will not likely increase the degree of threat to the species and would be beneficial, we find that designation of critical habitat is prudent for the meltwater lednian stonefly and the western glacier stonefly.

    Critical Habitat Determinability

    Having determined that designation is prudent, under section 4(a)(3) of the Act we must find whether critical habitat for meltwater lednian stonefly and western glacier stonefly is determinable. Our regulations (50 CFR 424.12(a)(2)) further state that critical habitat is not determinable when one or both of the following situations exists:

    (i) Data sufficient to perform required analyses are lacking, or

    (ii) The biological needs of the species are not sufficiently well known to identify any area that meets the definition of “critical habitat.”

    When critical habitat is not determinable, the Act allows the Service an additional year to publish a critical habitat designation (16 U.S.C. 1533(b)(6)(C)(ii)). In this instance, we find that critical habitat is not determinable at this time because data sufficient to perform the required analyses are lacking, as explained below.

    New information on western glacier stonefly was received late in the status review process (see Distribution and Abundance above), and this information has not yet been analyzed or incorporated. Consequently, a careful assessment of the new biological information is still ongoing. In the near future, we will begin reassessing which specific features and areas are essential for the conservation of the species and, therefore, meet the definition of critical habitat. This evaluation is needed in order to determine where to designate critical habitat for the western glacier stonefly. Once we have determined where to designate critical habitat for both species, we must also analyze the economic impacts of our proposed designation. The Service has conducted an economic analysis but that data may now be incomplete given the new information. The information sufficient to perform a required analysis of the impacts of the designation is lacking, and, therefore, we find designation of critical habitat to be not determinable at this time. Accordingly, we will publish a proposed critical habitat rule for both species in the near future when we finish our assessment of the new biological information.

    Required Determinations Clarity of the Rule

    We are required by Executive Orders 12866 and 12988 and by the Presidential Memorandum of June 1, 1998, to write all rules in plain language. This means that each rule we publish must:

    (1) Be logically organized;

    (2) Use the active voice to address readers directly;

    (3) Use clear language rather than jargon;

    (4) Be divided into short sections and sentences; and

    (5) Use lists and tables wherever possible.

    If you feel that we have not met these requirements, send us comments by one of the methods listed in ADDRESSES. To better help us revise the rule, your comments should be as specific as possible. For example, you should tell us the numbers of the sections or paragraphs that are unclearly written, which sections or sentences are too long, the sections where you feel lists or tables would be useful, etc.

    National Environmental Policy Act (42 U.S.C. 4321 et seq.)

    We have determined that environmental assessments and environmental impact statements, as defined under the authority of the National Environmental Policy Act (NEPA; 42 U.S.C. 4321 et seq.), need not be prepared in connection with listing a species as an endangered or threatened species under the Endangered Species Act. We published a notice outlining our reasons for this determination in the Federal Register on October 25, 1983 (48 FR 49244).

    Government-to-Government Relationship With Tribes

    In accordance with the President's memorandum of April 29, 1994 (Government-to-Government Relations with Native American Tribal Governments; 59 FR 22951), Executive Order 13175 (Consultation and Coordination With Indian Tribal Governments), and the Department of the Interior's manual at 512 DM 2, we readily acknowledge our responsibility to communicate meaningfully with recognized Federal Tribes on a government-to-government basis. In accordance with Secretarial Order 3206 of June 5, 1997 (American Indian Tribal Rights, Federal-Tribal Trust Responsibilities, and the Endangered Species Act), we readily acknowledge our responsibilities to work directly with tribes in developing programs for healthy ecosystems, to acknowledge that tribal lands are not subject to the same controls as Federal public lands, to remain sensitive to Indian culture, and to make information available to tribes. As part of our responsibilities to communicate meaningfully and work directly with Tribal Governments, we informed the Confederated Kootenai Salish Tribe (CKST) of our intent to conduct a status review on meltwater lednian stonefly, and solicited any information the Tribe may have regarding the sole population of meltwater lednian stonefly occurring in Tribal wilderness on CKST land.

    References Cited

    A complete list of references cited in this rulemaking is available on the Internet at http://www.regulations.gov at Docket No. FWS-R6-ES-2016-0086 and upon request from the Montana Ecological Services Field Office (see FOR FURTHER INFORMATION CONTACT).

    Authors

    The primary authors of this proposed rule are the staff members of the Montana Ecological Services Field Office.

    List of Subjects in 50 CFR Part 17

    Endangered and threatened species, Exports, Imports, Reporting and recordkeeping requirements, Transportation.

    Proposed Regulation Promulgation

    Accordingly, we propose to amend part 17, subchapter B of chapter I, title 50 of the Code of Federal Regulations, as set forth below:

    PART 17—ENDANGERED AND THREATENED WILDLIFE AND PLANTS 1. The authority citation for part 17 continues to read as follows: Authority:

    16 U.S.C. 1361-1407; 16 U.S.C. 1531-1544; 16 U.S.C. 4201-4245; unless otherwise noted.

    2. In § 17.11(h), add an entry for “Stonefly, meltwater lednian ” and an entry for “Stonefly, western glacier ” to the List of Endangered and Threatened Wildlife in alphabetical order under INSECTS to read as set forth below:
    § 17.11 Endangered and threatened wildlife.

    (h) * * *

    Common name Scientific name Where listed Status Listing citations and
  • applicable rules
  • *       *       *       *       *       *       * Insects *       *       *       *       *       *       * Stonefly, meltwater lednian Lednia tumana Wherever found T [Insert Federal Register citation when published as a final rule] Stonefly, western glacier Zapada glacier Wherever found T [Insert Federal Register citation when published as a final rule] *       *       *       *       *       *       *
    Dated: September 12, 2016 Stephen Guertin, Acting Director, U.S. Fish and Wildlife Service.
    [FR Doc. 2016-23710 Filed 10-3-16; 8:45 am] BILLING CODE 4333-15-P
    81 192 Tuesday, October 4, 2016 Notices DEPARTMENT OF AGRICULTURE Economic Research Service Submission for OMB Review; Comment Request September 28, 2016.

    The Department of Agriculture has submitted the following information collection requirement(s) to OMB for review and clearance under the Paperwork Reduction Act of 1995, Public Law 104-13. Comments are requested regarding (1) whether the collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility; (2) the accuracy of the agency's estimate of burden including the validity of the methodology and assumptions used; (3) ways to enhance the quality, utility and clarity of the information to be collected; and (4) ways to minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology.

    Comments regarding this information collection received by November 3, 2016 will be considered. Written comments should be addressed to: Desk Officer for Agriculture, Office of Information and Regulatory Affairs, Office of Management and Budget (OMB), New Executive Office Building, 725—17th Street NW., Washington, DC 20502. Commenters are encouraged to submit their comments to OMB via email to: [email protected] or fax (202) 395-5806 and to Departmental Clearance Office, USDA, OCIO, Mail Stop 7602, Washington, DC 20250-7602. Copies of the submission(s) may be obtained by calling (202) 720-8958.

    An agency may not conduct or sponsor a collection of information unless the collection of information displays a currently valid OMB control number and the agency informs potential persons who are to respond to the collection of information that such persons are not required to respond to the collection of information unless it displays a currently valid OMB control number.

    Economic Research Service

    Title: National Food Study Pilot.

    OMB Control Number: 0536-NEW.

    Summary of Collection: The Economic Research Service (ERS) will be conducting the National Alternative Data Collection Method (ADCM) for Collecting FoodAPS-Like Data Study (aka National Food Study Pilot). The mission of ERS is to provide timely research and analysis to public and private decision makers on topics related to agriculture, food, the environment, and rural America. To achieve this mission, ERS requires a variety of data that describe agricultural production, food distribution channels, availability and price of food at the point of sale, and household demand for food products. Section 17 (U.S.C. 2026) (a) (1) of the Food and Nutrition Act of 2008 provides legislative authority for the planned data collection. .

    Need and Use of the Information: The main objective of the National Food Study Pilot (NSF) is to test an alternative method of collecting data on the food acquired by American households that leads to more complete and accurate information about patterns of food acquisitions. The NSF Pilot will make use of the latest computer technologies to collect data on foods acquired and to monitor data. The data collection will provide information that is critical to ERS' plans for the next round of FoodAPS data collection. The NSF Pilot findings will be used to improve the sampling design and data collection methodology for the next FoodAPS Study.

    Description of Respondents: Individuals or household.

    Number of Respondents: 2,500.

    Frequency of Responses: Reporting: On occasion.

    Total Burden Hours: 6,575.

    Ruth Brown, Departmental Information Collection Clearance Officer.
    [FR Doc. 2016-23869 Filed 10-3-16; 8:45 am] BILLING CODE 3410-18-P
    DEPARTMENT OF AGRICULTURE Food and Nutrition Service Agency Information Collection Activities: Proposed Collection; Comment Request—Child Nutrition Program Operations Study II (CN-OPS-II) AGENCY:

    Food and Nutrition Service, United States Department of Agriculture (USDA).

    ACTION:

    Notice and request for comments.

    SUMMARY:

    In accordance with the Paperwork Reduction Act of 1995, this notice invites the general public and other public agencies to comment on this proposed information collection. This collection is a revision of a currently approved collection for the Child Nutrition Program Operations Study II (CN-OPS-II) (OMB Number 0584-0607, Expiration Date: 04/30/2019).

    DATES:

    Written comments must be received on or before December 5, 2016.

    ADDRESSES:

    Comments are invited on (a) Whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility; (b) the accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions that were used; (c) ways to enhance the quality, utility, and clarity of the information to be collected; and (d) ways to minimize the burden of the collection of information on those who are to respond, including use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology. Comments may be sent to: Devin Wallace-Williams, Ph.D., Social Science Research Analyst, Office of Policy Support, Food and Nutrition Service, USDA, 3101 Park Center Drive, VA 22302. Comments may also be submitted via fax to the attention of Devin Wallace-Williams at 703-305-2576 or via email to [email protected] Comments will also be accepted through the Federal eRulemaking Portal. Go to http://www.regulations.gov, and follow the online instructions for submitting comments electronically.

    All responses to this notice will be summarized and included in the request for Office of Management and Budget approval. All comments will be a matter of public record.

    FOR FURTHER INFORMATION CONTACT:

    To request more information on the proposed project, contact Devin Wallace-Williams, Ph.D., Social Science Research Analyst, Office of Policy Support, Food and Nutrition Service, USDA, 3101 Park Center Drive, Alexandria, VA 22302; Fax: 703-305-2576; Email: [email protected]

    SUPPLEMENTARY INFORMATION:

    Title: Child Nutrition Program Operations Study II (CN-OPS-II).

    Form Number: N/A. OMB Number: 0584-0607.

    Expiration Date: 04/30/2019.

    Type of Request: Revision of a currently approved collection.

    Abstract: The objective of the Child Nutrition Program Operations Study II (CN-OPS-II) is to collect timely data on policies, administrative, and operational issues on the Child Nutrition Programs (CNP). The ultimate goal is to analyze these data and to provide input for new legislation on Child Nutrition Programs, as well as to provide pertinent technical assistance and training to program implementation staff.

    CN-OPS-II will help the Food and Nutrition Service (FNS) better understand and address current policy issues related to CNP operations. The policy and operational issues include, but are not limited to, the preparation of the program budget, development and implementation of program policy and regulations, and identification of areas for technical assistance and training. Specifically, this study will help FNS obtain:

    • General descriptive data on the CN program characteristics to help FNS respond to questions about the nutrition programs in schools;

    • Data related to program administration for designing and revising program regulations, managing resources, and reporting requirements; and

    • Data related to program operations to help FNS develop and provide training and technical assistance for School Food Authorities (SFAs) and State Agencies responsible for administering the CN programs.

    The activities to be undertaken subject to this notice include:

    • Conducting a multi-modal (e.g. paper, web, and telephone) survey of approximately 1,750 SFA Directors in School Year (SY) 2016-17, SY 2017-18, and SY 2018-19; and

    • Conducting a multi-modal (e.g. paper, web, and telephone) survey of all 55 State Agency CN Directors in SY 2016-17, SY 2017-18, and SY 2018-19.

    Affected Public: State, Local and Tribal Governments.

    Type of Respondents: SFA Directors and State CN Directors.

    Estimated Total Number of Respondents: 2,251 annually, including 1,813 respondents and 438 non-respondents.

    Frequency of Responses per Respondent: 3.

    Estimated Total Annual Responses: 6737 responses across the entire collection. This includes 5,423 for the respondents and 1,314 for the non-respondents.

    Estimate of Time per Respondent and Annual Burden: The average time across all respondents is 42 minutes (0.70 hours). This includes 3.5 minutes (0.06 hours) for non-respondents and 51 minutes (0.85 hours) for respondents. The total annual reporting burden is estimated at 4,699 (see Exhibit 1. Estimates of Respondent Burden). The estimates presented are expected to be typical of the burden in each year of data collection. FNS will submit amended estimates if burden deviates significantly for a particular year.

    Dated: September 20, 2016. Telora T. Dean, Acting Administrator, Food and Nutrition Service. BILLING CODE 3410-30-P EN04OC16.140
    [FR Doc. 2016-23859 Filed 10-3-16; 8:45 am] BILLING CODE 3410-30-C
    DEPARTMENT OF AGRICULTURE National Institute of Food and Agriculture Notice of Request for an Information Collection; Generic Clearance for the Collection of Qualitative Feedback on Agency Service Delivery AGENCY:

    National Institute of Food and Agriculture.

    ACTION:

    Notice and request for comments.

    SUMMARY:

    The National Institute of Food and Agriculture, as part of its continuing effort to reduce paperwork and respondent burden, invites the general public to take this opportunity to comment on the “Generic Clearance for the Collection of Qualitative Feedback on Agency Service Delivery” for approval under the Paperwork Reduction Act (PRA). This collection was developed to create a vehicle for obtaining stakeholder feedback. This notice announces our intent to submit this collection to Office of Management and Budget for approval and solicits comments on specific aspects for the proposed information collection.

    DATES:

    Consideration will be given to all comments received by December 5, 2016. Comments received after that date will be considered to the extent practicable.

    ADDRESSES:

    Written comments may be submitted by any of the following methods: Email: [email protected]; Fax: 202-720-0857; Mail: Office of Information Technology (OIT), NIFA, USDA, STOP 2216, 1400 Independence Avenue SW., Washington, DC 20250-2216.

    FOR FURTHER INFORMATION CONTACT:

    Robert Martin, Records Officer; email: [email protected]

    SUPPLEMENTARY INFORMATION:

    Title: Generic Clearance for the Collection of Qualitative Feedback on Agency Service Delivery.

    Abstract: The National Institute of Food and Agriculture (NIFA), U.S. Department of Agriculture, oversees roughly $1.5 billion to fund research, education, and extension efforts in a wide range of scientific fields related to agricultural and behavioral sciences. NIFA achieves its mission through partnerships with Land-Grant Universities (LGU), non-profit organizations, private sector firms, and other government agencies. These partners, through research, education, and extension activities, help NIFA and USDA address highly complex and multidimensional challenges in food and agriculture. To ensure that our programs address the Nation's food and agricultural priorities and our processes minimize burden without jeopardizing accountability, NIFA seeks OMB approval of a generic clearance to collect qualitative feedback on our service delivery. By qualitative feedback, we mean information that provides insights on perceptions and opinions, but are not statistical surveys or quantitative results that can be generalized to the population of study.

    This collection of information is necessary to enable NIFA, herein “the Agency,” to garner feedback from customers, stakeholders, and partners (herein “stakeholders”) in an efficient and timely manner, and in accordance with our commitment to providing the highest quality service delivery. The information collected from our stakeholders will help NIFA identify emerging and significant priorities in food and agriculture; refine NIFA's business processes; and promote inclusiveness and diversity to ensure that NIFA drives outcomes that meets the needs of all Americans.

    Improving agency programs requires ongoing assessment of NIFA's programs and processes, by which we mean systematic review of the operation of a program compared to a set of explicit or implicit standards. NIFA will collect, analyze, and interpret information gathered through this generic clearance to identify strengths and weaknesses of current services and make improvements based on stakeholder feedback. If this information is not collected, NIFA's ability to respond to stakeholders' needs and continuously improve programs and services will be greatly diminished.

    The solicitation of feedback will target areas in: Strategic, portfolio, and programmatic planning; competitive and non-competitive awards processes; post-award management; information technology systems and Web sites; and, grants management training. Responses will inform efforts to improve or maintain the quality of service offered to the public.

    The Agency will only submit a collection for approval under this generic clearance if it meets the following conditions:

    • The collections are voluntary;

    • The collections are low-burden for respondents (based on considerations of total burden hours, total number of respondents, or burden-hours per respondent) and are low-cost for both the respondents and the Federal Government;

    • The collections are non-controversial and do not raise issues of concern to other Federal agencies;

    • Any collection is targeted to the solicitation of opinions from respondents who have experience with the program or may have experience with the program in the near future;

    • Information gathered will be used only internally for general service improvement and program management purposes and is not intended for release outside of the agency;

    • Information gathered will not be used for the purpose of substantially informing influential policy decisions; and

    • Information gathered will yield qualitative information; the collections will not be designed or expected to yield statistically reliable results or used as though the results are generalizable to the population of study.

    Feedback collected under this generic clearance provides useful information, but it does not yield data that can be generalized to the overall population. This type of generic clearance for qualitative information will not be used for quantitative information collections that are designed to yield reliably actionable results, such as monitoring trends over time or documenting program performance. Such data uses require more rigorous designs that address: the target population to which generalizations will be made, the sampling frame, the sample design (including stratification and clustering), the precision requirements or power calculations that justify the proposed sample size, the expected response rate, methods for assessing potential non-response bias, the protocols for data collection, and any testing procedures that were or will be undertaken prior to fielding the study. Depending on the degree of influence the results are likely to have, such collections may still be eligible for submission for other generic mechanisms that are designed to yield quantitative results.

    As a general matter, information collections will not result in any new system of records containing privacy information and will not ask questions of a sensitive nature, such as sexual behavior and attitudes, religious beliefs, and other matters that are commonly considered private.

    Current Actions: Request for approval for a new collection of information.

    Type of Review: New.

    Affected Public: Individuals and Households, Businesses and Organizations, State, Local or Tribal Government.

    Estimated Number of Respondents: 11,250.

    Below we provide projected average estimates for the next three years:

    Average Expected Annual Number of activities: 15.

    Average number of Respondents per Activity: 750.

    Annual responses: 11,250.

    Frequency of Response: Once per request.

    Average minutes per response: 30.

    Burden hours: 5,625.

    Request for Comments: Comments submitted in response to this notice will be summarized and/or included in the request for OMB approval. Comments are invited on: (a) Whether the collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility; (b) the accuracy of the agency's estimate of the burden of the collection of information; (c) ways to enhance the quality, utility, and clarity of the information to be collected; (d) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or other forms of information technology; and (e) estimates of capital or start-up costs and costs of operation, maintenance, and purchase of services to provide information. Burden means the total time, effort, or financial resources expended by persons to generate, maintain, retain, disclose or provide information to or for a Federal agency. This includes the time needed to review instructions; develop, acquire, install and utilize technology and systems for the purpose of collecting, validating and verifying information, processing and maintaining information, and disclosing and providing information; train personnel and to be able to respond to a collection of information, to search data sources, to complete and review the collection of information; and to transmit or otherwise disclose the information.

    All written comments will be available for public inspection on Regulations.gov.

    An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid Office of Management and Budget control number.

    Done at Washington, DC, this 23rd day of September, 2016. Catherine E. Woteki, Under Secretary, Research, Education, and Economics.
    [FR Doc. 2016-23956 Filed 10-3-16; 8:45 am] BILLING CODE 3410-22-P
    DEPARTMENT OF AGRICULTURE Rural Business-Cooperative Service Notice of Request for Extension of a Currently Approved Information Collection AGENCY:

    Rural Business-Cooperative Service, USDA.

    ACTION:

    Proposed collection; comments requested.

    SUMMARY:

    In accordance with the Paperwork Reduction Act of 1995, this notice announces the Rural Business-Cooperative Service's intention to request an extension for a currently approved information collection in support of the Rural Economic Development Loan and Grant Program.

    DATES:

    Comments on this notice must be received by December 5, 2016, to be assured of consideration.

    FOR FURTHER INFORMATION CONTACT:

    Director, Specialty Programs Division, Rural Business-Cooperative Service, U.S. Department of Agriculture, STOP 3226, 1400 Independence Avenue SW., Washington, DC 20250-3226, Telephone (202) 720-1400.

    SUPPLEMENTARY INFORMATION:

    Title: Rural Economic Development Loan and Grant Program.

    OMB Number: 0570-0035.

    Expiration Date of Approval: February 28, 2017.

    Type of Request: Extension of a currently approved information collection.

    Abstract: Under this program, loans and grants are provided to electric and telecommunications utilities that have borrowed funds from the Agency. The purpose of the program is to encourage these electric and telecommunications utilities to promote rural economic development and job creation projects such as business start-up costs, business expansion, community development, and business incubator projects. The utilities must use program loan funds to make a pass-through loan to an ultimate recipient such as a business. The utility is responsible for fully repaying its loan to the Government, even if the ultimate recipient does not repay its loan. The intermediary must use program grant funds, along with its required contribution, to create a revolving loan fund that the utility will operate and administer. Loans to the ultimate recipient are made from the revolving loan fund for a variety of community development projects. The information requested is necessary and vital in order for the Agency to be able to make prudent and financial analysis decisions.

    Estimate of Burden: Public reporting burden for this collection of information is estimated to average 2 hours per response.

    Respondents: Rural Utilities Service Electric and Telecommunications Borrowers.

    Estimated Number of Respondents: 120.

    Estimated Number of Responses per Respondent: 17.

    Estimated Number of Responses: 2,075.

    Estimated Total Annual Burden on Respondents: 4,728.

    Copies of this information collection can be obtained from Jeanne Jacobs, Regulations and Paperwork Management Branch, Support Services Division at (202) 692-0040.

    Comments: Comments are invited on: (a) Whether the proposed collection of information is necessary for the proper performance of the functions of USDA, including whether the information will have practical utility; (b) the accuracy of USDA's estimate of the burden of the proposed collection of information including the validity of the methodology and assumptions used; (c) ways to enhance the quality, utility and clarity of the information to be collected; and (d) ways to minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology. Comments may be sent to Jeanne Jacobs, Regulations and Paperwork Management Branch, Support Services Division, U.S. Department of Agriculture, Rural Development, STOP 0742, 1400 Independence Avenue SW., Washington, DC 20250-0742. All responses to this notice will be summarized and included in the request for OMB approval. All comments will also become a matter of public record.

    Dated: September 28, 2016. Justin Hatmaker, Acting Administrator, Rural Business-Cooperative Service.
    [FR Doc. 2016-23914 Filed 10-3-16; 8:45 am] BILLING CODE 3410-XY-P
    DEPARTMENT OF AGRICULTURE Rural Business-Cooperative Service Notice of Request for Extension of a Currently Approved Information Collection AGENCY:

    Rural Business-Cooperative Service, Department of Agriculture.

    ACTION:

    Proposed Collection; Comments Requested.

    SUMMARY:

    In accordance with the Paperwork Reduction Act of 1995 (44 U.S.C. Chapter 35), this Notice announces the Rural Business-Cooperative Service intention to request an extension for to a currently approved information collection for the Rural Microentrepreneur Assistance Program (RMAP).

    DATES:

    Comments on this notice must be received by December 5, 2016 to be assured of consideration.

    ADDITIONAL INFORMATION OR COMMENTS:

    Director, Specialty Programs Division, Rural Business-Cooperative Service, U.S. Department of Agriculture, 1400 Independence Avenue SW., Washington, DC 20250-3226, Telephone (202) 720-1400,

    SUPPLEMENTARY INFORMATION:

    Title: Rural Microentrepreneur Assistance Program.

    OMB Number: 0570-0062.

    Expiration Date of Approval: February 28, 2017.

    Type of Request: Extension and revision of a currently approved information collection.

    Abstract: The purpose of the RMAP program is to support the development and ongoing success of rural microentrepreneurs and microenterprises. Direct loans and grants are made to selected Microenterprise Development Organizations (MDOs).

    Estimate of Burden: Public reporting burden for this collection of information is estimated to average 2 hours per response.

    Respondents: Nonprofits, Indian Tribes, and Public Institutions of Higher Education.

    Estimated Number of Respondents: 75.

    Estimated Number of Responses per Respondent: 20.

    Estimated Number of Responses: 1506.

    Estimated Total Annual Burden Hours on Respondents: 3,254 hours.

    Comments are invited on: (1) Whether the proposed collection of information is necessary for the proper performance of the functions of the Agency, including whether the information will have practical utility; (2) the accuracy of the Agency's estimate of the burden of the proposed collection of information including the validity of the methodology and assumptions used; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) ways to minimize the burden of the collection of information on those who are to respond, including the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology. Comments may be sent to Jeanne Jacobs, Regulations and Paperwork Management Branch, Support Services Division, U.S. Department of Agriculture, Rural Development, 1400 Independence Avenue SW., STOP 0742, Washington, DC 20250. All comments received will be available for public inspection during regular business hours at the same address.

    All responses to this notice will be summarized and included in the request for Office of Management and Budget approval. All comments will become a matter of public record.

    Dated: September 28, 2016. Justin Hatmaker, Acting Administrator, Rural Business-Cooperative Service.
    [FR Doc. 2016-23915 Filed 10-3-16; 8:45 am] BILLING CODE P
    DEPARTMENT OF AGRICULTURE Rural Utility Service Submission for OMB Review; Comment Request September 29, 2016.

    The Department of Agriculture has submitted the following information collection requirement(s) to Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995, Public Law 104-13. Comments are requested regarding (1) whether the collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility; (2) the accuracy of the agency's estimate of burden including the validity of the methodology and assumptions used; (3) ways to enhance the quality, utility and clarity of the information to be collected; (4) ways to minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology.

    Comments regarding this information collection received by November 3, 2016 will be considered. Written comments should be addressed to: Desk Officer for Agriculture, Office of Information and Regulatory Affairs, Office of Management and Budget (OMB), New Executive Office Building, 725—17th Street NW., Washington, DC 20502. Commenters are encouraged to submit their comments to OMB via email to: [email protected] or fax (202) 395-5806 and to Departmental Clearance Office, USDA, OCIO, Mail Stop 7602, Washington, DC 20250-7602. Copies of the submission(s) may be obtained by calling (202) 720-8958.

    An agency may not conduct or sponsor a collection of information unless the collection of information displays a currently valid OMB control number and the agency informs potential persons who are to respond to the collection of information that such persons are not required to respond to the collection of information unless it displays a currently valid OMB control number.

    Rural Utilities Service

    Title: Broadband Grant Program.

    OMB Control Number: 0572-0127.

    Summary of Collection: Congress has recognized the need to facilitate the deployment of broadband service to un-served rural areas. The provision to broadband transmission service is vital to the economic development, education, health, and safety of rural Americans.

    The Consolidated Appropriations Act, 2004 (Title III, Pub. L. 108-199, Stat.3), 7 CFR 1739 Subpart A, as amended, authorizes the Rural Development, Rural Utilities Service (RUS) to administer the Community Connect Grant Program for the provision of broadband transmission service in rural America. Grant authority is utilized to deploy broadband infrastructure to extremely rural, lower income communities on a “community-oriented connectivity” basis.

    Need and Use of the Information: RUS gives priority to rural areas that it believes have the greatest need for broadband transmission services. This broadband access is intended to promote economic development and provide enhanced educational and health care opportunities. RUS will provide financial assistance to eligible entities that are proposing to deploy broadband transmission service in rural communities where such service does not currently exist and who will connect the critical community facilities including the local schools, libraries, hospitals, police, fire and rescue services and who will operate a community center that provides free and open access to residents.

    Description of Respondents: Business or other for-profit; Not-for-profit institutions; State, Local and Tribal Governments.

    Number of Respondents: 70.

    Frequency of Responses: Reporting; On occasion.

    Total Burden Hours: 11,380.

    Charlene Parker, Departmental Information Collection Clearance Officer.
    [FR Doc. 2016-23932 Filed 10-3-16; 8:45 am] BILLING CODE 3410-15-P
    DEPARTMENT OF COMMERCE Foreign-Trade Zones Board [B-65-2016] Foreign-Trade Zone (FTZ) 158—Vicksburg/Jackson, Mississippi; Notification of Proposed Production Activity; MTD Consumer Group, Inc. (Lawn and Garden Equipment); Verona, Mississippi

    MTD Consumer Group, Inc. (MTD), submitted a notification of proposed production activity to the FTZ Board for its facility in Verona, Mississippi, within FTZ 158. The notification conforming to the requirements of the regulations of the FTZ Board (15 CFR 400.22) was received on September 13, 2016.

    The MTD facility is located within Site 17 of FTZ 158. The facility is used for the production of lawn and garden equipment. Pursuant to 15 CFR 400.14(b), FTZ activity would be limited to the specific foreign-status materials and components and specific finished products described in the submitted notification (as described below) and subsequently authorized by the FTZ Board.

    Production under FTZ procedures could exempt MTD from customs duty payments on the foreign-status components used in export production. On its domestic sales, MTD would be able to choose the duty rates during customs entry procedures that apply to water pumps; blowers; power washers; tillers; de-thatchers; aerators; snow throwers; walk behind mowers; mower attachments; edgers; wheeled string trimmers; chippers; shredders; chipper/shredder/vacuums (CSVs); log splitters; and, 2-wheel tractors (duty rates range between free and 2.4%) for the foreign-status inputs noted below. Customs duties also could possibly be deferred or reduced on foreign-status production equipment.

    The components and materials sourced from abroad include: polyvinyl chloride tubes; plastic flexible hoses/adhesive labels/bagger cover panels; rubber v-belts/tire inner tubes/0-rings/oil seals/water seals/plugs; cardboard retail cartons; textile grass catcher bags; steel hydraulic fittings/control cables/screw rings/hexagonal head bolts/nuts/washers/pins/springs/mower blades; metal frame brackets; gasoline-powered engines; engine shrouds; hydraulic cylinders; reciprocating positive displacement pumps; hydraulic fluid power pumps; pump parts (ports, bodies and cores); wheels for leaf blowers; hydraulic fluid inlet filters; air cleaners; pressure washer spray gun/nozzle fittings/nozzle extension tubes; snow thrower wheels; block joint assemblies for snow throwers; tiller parts (tine/handle assemblies, handle covers, tines, bails, drive handles, handle height adjuster plates); lawn mower wheels; water nozzle adapters for lawn mower decks; blower chutes for lawn mowers; wheeled string trimmer bodies; string trimmer handles; log splitter wheels; hitch coupling assemblies for log splitters; steel screens for wood chippers; wedges for wood chippers; edger wheels; manual directional valves for hydraulic fluid on log splitters; valve parts for log splitters; radial ball bearings; transmission shafts/cranks/assemblies; worm gears; gearbox housings; metal magnets; motor starters; axles for 2-wheel tractors; and, wheel barrow/cart wheels with tires (duty rates range from free to 9%).

    Public comment is invited from interested parties. Submissions shall be addressed to the FTZ Board's Executive Secretary at the address below. The closing period for their receipt is November 14, 2016.

    A copy of the notification will be available for public inspection at the Office of the Executive Secretary, Foreign-Trade Zones Board, Room 21013, U.S. Department of Commerce, 1401 Constitution Avenue NW., Washington, DC 20230-0002, and in the “Reading Room” section of the FTZ Board's Web site, which is accessible via www.trade.gov/ftz.

    For further information, contact Diane Finver at [email protected] or (202) 482-1367.

    Dated: September 27, 2016. Andrew McGilvray, Executive Secretary.
    [FR Doc. 2016-23965 Filed 10-3-16; 8:45 am] BILLING CODE 3510-DS-P
    DEPARTMENT OF COMMERCE International Trade Administration [C-580-879] Certain Corrosion-Resistant Steel Products From the Republic of Korea: Initiation of Expedited Review of the Countervailing Duty Order AGENCY:

    Enforcement and Compliance, International Trade Administration, Department of Commerce.

    SUMMARY:

    The Department of Commerce (the Department) is initiating an expedited review of the countervailing duty order on certain corrosion-resistant steel products (CORE) from the Republic of Korea (Korea) with respect to POSCO and Hyundai Steel Company (Hyundai).

    DATES:

    Effective October 4, 2016.

    FOR FURTHER INFORMATION CONTACT:

    Myrna Lobo, AD/CVD Operations, Enforcement and Compliance, International Trade Administration, U.S. Department of Commerce, 14th Street and Constitution Avenue NW., Washington, DC 20230; telephone (202) 482-2371.

    SUPPLEMENTARY INFORMATION:

    Background

    On July 25, 2016, the Department published the countervailing duty order on CORE from Korea.1 On August 24, 2016, the Department received requests from POSCO and Hyundai to conduct an expedited review of this countervailing duty order.2 POSCO and Hyundai were not selected for individual examination during the investigation and made these requests pursuant to 19 CFR 351.214(k).

    1See Certain Corrosion-Resistant Steel Products From India, Italy, Republic of Korea and the People's Republic of China: Countervailing Duty Order, 81 FR 48387 (July 25, 2016).

    2See letter from POSCO, “Corrosion-Resistant Steel Products from South Korea, Case No. C-580-879: Request for Expedited Review Pursuant to 19 CFR 351.214(k),” (August 24, 2016). See also letter from Hyundai, “Corrosion-Resistant Steel Products from South Korea, Case No. C-580-879: Request for Expedited Review Pursuant to 19 CFR 351.214(k),” (August 24, 2016).

    Initiation of Expedited Review

    In accordance with 19 CFR 351.214(k)(1)(i)-(iii), POSCO and Hyundai each certified that it exported the subject merchandise to the United States during the period of investigation; that it was not affiliated with an exporter or producer that the Department individually examined in the investigation; and that it informed the Government of Korea, as the government of the exporting country, that the government will be required to provide a full response to the Department's questionnaire.

    Therefore, in accordance with 19 CFR 351.214(k), we are initiating an expedited review of the countervailing duty order on CORE from Korea. Pursuant to 19 CFR 351.214(i)(1) and (k)(3), we intend to issue the preliminary results of this expedited review not later than 180 days from the date of initiation of this review.3 As specified by 19 CFR 351.214(k)(3)(i), the period of review will be the same as the original period of investigation, i.e., January 1, 2014, through December 31, 2014.

    3 Under 19 CFR 351.214(k)(i)(2), this period may be extended to 300 days.

    Pursuant to 19 CFR 351.214(k)(3)(iii), the final results of this expedited review will not be the basis for the assessment of countervailing duties. Instead, this expedited review is intended to establish individual cash deposit rates for POSCO and Hyundai, or to exclude from the countervailing duty order a company for which the final results of review are zero or de minimis, as provided in 19 CFR 351.214(k)(3)(iv) .

    Interested parties must submit applications for disclosure under administrative protective orders in accordance with 19 CFR 351.305 and 351.306.

    Dated: September 28, 2016. Christian Marsh, Deputy Assistant Secretary for Antidumping and Countervailing Duty Operations.
    [FR Doc. 2016-23967 Filed 10-3-16; 8:45 am] BILLING CODE 3510-DS-P
    DEPARTMENT OF COMMERCE National Oceanic and Atmospheric Administration RIN 0648-XC901 Endangered and Threatened Species; Announcement of a Recovery Planning Workshop and Request for Information AGENCY:

    National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Department of Commerce.

    ACTION:

    Notice; request for information.

    SUMMARY:

    We, NMFS, are convening a workshop to solicit facts and information from experts to inform recovery planning for the Main Hawaiian Islands (MHI) insular false killer whale (Pseudorca crassidens) Distinct Population Segment (DPS). This workshop will be open to the public. We also request information that might inform the development of the recovery plan. On October 2, 2013, we published a Notice of Intent to prepare a Recovery Plan and Request for Information for this DPS. We received seven public comments in response to that notice, which remain relevant and will be considered in the recovery planning process. Because significant time has elapsed since this last request, we are requesting any additional information that has become available in the interim.

    DATES:

    Workshop dates and information: The four-day recovery planning workshop for the MHI insular false killer whale DPS will be held Tuesday, October 25 through Friday, October 28, 2016, at the Ohana Waikiki East Hotel, 150 Kaiulani Ave., Honolulu, HI 96815. The workshop will begin each day at 9 a.m. and end each day at 5:30 p.m. or as necessary to complete business for the day.

    RSVP date: If you plan to attend the workshop as an interested member of the public, please contact Krista Graham, NMFS, Pacific Islands Regional Office, [email protected], 808-725-5152 no later than October 21, 2016.

    Date for information submission: Please submit information to inform recovery planning via the methods listed below in the ADDRESSES section by December 5, 2016.

    ADDRESSES:

    You may submit information by either of the following methods:

    Mail: Krista Graham, NMFS Pacific Islands Regional Office, Protected Resources Division, 1845 Wasp Blvd., Building 176, Honolulu, HI 96818.

    Electronic Submissions: Submit all electronic information that may inform the development of recovery criteria and actions via email to [email protected] (No files larger than 5MB can be accepted).

    FOR FURTHER INFORMATION CONTACT:

    Krista Graham, NMFS, Pacific Islands Regional Office, 808-725-5152. You may also visit our Web site at: http://www.fpir.noaa.gov/PRD/prd_mhi_false_killer_whale.html#fwk_esa_listing.

    SUPPLEMENTARY INFORMATION:

    Background

    On November 28, 2012, we published a final rule listing the MHI insular false killer whale DPS as endangered under the Endangered Species Act (ESA) (77 FR 70915). The final listing rule describes the background of the listing action for this DPS and provides a summary of our conclusions regarding its status. For additional background and a summary of natural history and threats to the species, the reader is referred to the status review report and final listing rule (available at http://www.fpir.noaa.gov/PRD/prd_mhi_false_killer_whale.html).

    NMFS is required by section 4(f) of the ESA to develop and implement recovery plans for the conservation and survival of federally listed species unless the Secretary finds that such a plan will not promote the conservation of the species. Recovery means that listed species and their ecosystems are restored, and their future secured, so that the protections of the ESA are no longer necessary. The ESA specifies that recovery plans are to include (1) a description of site-specific management actions necessary to achieve the plan's goals for the conservation and survival of the species; (2) objective, measurable criteria which, when met, would result in the species being removed from the list; and (3) estimates of the time and costs required to carry out the actions and achieve the plan's conservation goals. Under Section 4(f) of the ESA, public notice and an opportunity for public review and comment are also provided during recovery plan development. We published a Notice of Intent and Request for Information to Prepare a Recovery Plan for this DPS in October of 2013 (78 FR 60850). We received seven substantive public comments in response to that notice, which remain relevant and will be considered in the recovery planning process. Because significant time has elapsed since the last request, we are requesting any relevant information that may have become available.

    This notice and request for information serves as a second public notice and opportunity for public input early in the process. Once a recovery plan has been drafted, it will be announced in the Federal Register and available on our Web site (see ADDRESSES section) for public review and comment before being finalized.

    Recovery Planning Workshop Announcement

    From October 25 through 28, 2016, NMFS will hold a workshop at the Ohana Waikiki East Hotel in Honolulu, HI to help inform our recovery planning for the MHI insular false killer whale DPS (see DATES section). We are inviting experts in specific topic areas, including the species' biology/ecology, threats to the species and the species' habitat, and the recovery planning process itself. These experts will help us to update the threats analysis from the listing rule, and identify potential actions to address the threats. Identified experts include representatives of Federal and state agencies, scientific experts, individuals from conservation partners and non-governmental organizations, and commercial and recreational fishermen. Information received at the workshop may be used to inform the development of other conservation decisions and actions, including the designation of critical habitat.

    NMFS will provide a moderator to manage the workshop as well as a notetaker to document input received. We are seeking only individual analysis, facts, and opinions from participants. Questions to the participants will be limited to those necessary to clarify the expert's presentation and questions seeking consensus among panelists or experts will not be entertained. NMFS also will provide a time-limited question and answer period during which attendees may ask NMFS about information presented. NMFS will prepare a summary of the workshop, noting the main points raised by the panelists and registered speakers.

    This workshop will be open to the public, and a public comment period will be provided at the end of each session. If you plan to attend the workshop as an interested member of the public, please contact Krista Graham at the address listed above by October 21, 2016, so we can ensure sufficient space for all participants and interested parties during our logistics planning.

    Agenda

    ○ October 25-26 will focus on recovery actions and criteria related to non-longline commercial and recreational fisheries interactions;

    ○ October 27 will focus on recovery actions and criteria related to nutrition, i.e., prey size/biomass, distribution, and competition with fisheries;

    ○ October 28 will focus on recovery actions and criteria related to other threats to both the species itself and its habitat including noise and contaminants.

    Request for Information

    We also invite the public to submit scientific or commercial information that may help to inform the recovery criteria and actions for the MHI insular false killer whale DPS. We are soliciting relevant information related to the MHI insular false killer whale and its habitat, including the following:

    1. Criteria for removing the MHI insular false killer whale from the list of threatened and endangered species (this could be either threats-based or abundance/trends based);

    2. Human activities that contribute to threats to the species;

    3. Physical, biological or chemical features of the environment that limit the recovery of the MHI insular false killer whale;

    4. Recovery strategies addressing threats to physical and biological features that are essential to species conservation;

    5. Strategies and/or actions to recover the MHI insular false killer whale;

    6. Estimates of the time and cost to implement recovery actions;

    7. Critical knowledge gaps and/or uncertainties that need to be resolved to better inform recovery efforts; and

    8. Research, monitoring, and evaluation needs to address knowledge gaps and uncertainties, or to assess the species' status, limiting factors, and threats relative to recovery goals.

    Information may be submitted via the methods listed above in the ADDRESSES section.

    The workshop is accessible to persons with disabilities. Send requests for sign language interpretation or other auxiliary aids at least five business days in advance to Krista Graham at 808-725-5152.

    Authority:

    16 U.S.C. 1531 et seq.

    Dated: September 28, 2016. Nicole R. LeBoeuf, Acting Deputy Director, Office of Protected Resources, National Marine Fisheries Service.
    [FR Doc. 2016-23857 Filed 10-3-16; 8:45 am] BILLING CODE 3510-22-P
    DEPARTMENT OF COMMERCE National Oceanic and Atmospheric Administration RIN 0648-XE913 Marine Mammals; File No. 20452 AGENCY:

    National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.

    ACTION:

    Notice; receipt of application.

    SUMMARY:

    Notice is hereby given that SMRU Consulting North America, LLC, P.O. Box 764, Friday Harbor, WA 98250, has applied in due form for a permit to conduct research on harbor porpoises and harbor seals in Admiralty Inlet and the San Juan Islands, Washington.

    DATES:

    Written, telefaxed, or email comments must be received on or before November 3, 2016.

    ADDRESSES:

    The application and related documents are available for review by selecting “Records Open for Public Comment” from the “Features” box on the Applications and Permits for Protected Species (APPS) home page, https://apps.nmfs.noaa.gov, and then selecting File No. 20452 from the list of available applications.

    These documents are also available upon written request or by appointment in the Permits and Conservation Division, Office of Protected Resources, NMFS, 1315 East-West Highway, Room 13705, Silver Spring, MD 20910; phone (301) 427-8401; fax (301) 713-0376.

    Written comments on this application should be submitted to the Chief, Permits and Conservation Division, at the address listed above. Comments may also be submitted by facsimile to (301) 713-0376, or by email to [email protected] Please include the File No. in the subject line of the email comment.

    Those individuals requesting a public hearing should submit a written request to the Chief, Permits and Conservation Division at the address listed above. The request should set forth the specific reasons why a hearing on this application would be appropriate.

    FOR FURTHER INFORMATION CONTACT:

    Sara Young or Carrie Hubard, (301) 427-8401.

    SUPPLEMENTARY INFORMATION:

    The subject permit is requested under the authority of the Marine Mammal Protection Act of 1972, as amended (MMPA; 16 U.S.C. 1361 et seq.) and the regulations governing the taking and importing of marine mammals (50 CFR part 216).

    The applicant proposes to characterize the behavioral responses of harbor porpoise (Phocoena phocoena) and harbor seal (Phoca vitulina) to marine renewable energy devices, and to characterize the fine scale habitat use of marine mammals in tidal inlets to inform collision risk with tidal turbines. Behavioral responses to tidal turbine noise will be addressed with an experimental playback approach. The playback studies will be undertaken in the inland waters of Washington State using a combination of land-based surveys and passive acoustic monitoring methods. Studies to characterize the fine scale habitat use of harbor porpoise and pinnipeds in tidal inlets will use a combination of land-based and unmanned aerial system surveys, and will also be carried out in the inland waters of Washington State during 2016-2021. The applicant requests 244 Level B takes of harbor porpoise between two study areas, 416 takes of harbor seals, 154 Steller sea lions (Eumetopias jubatus), and 7 California sea lions (Zalophus californianus) by means of acoustic playbacks and UAS.

    In compliance with the National Environmental Policy Act of 1969 (42 U.S.C. 4321 et seq.), an initial determination has been made that the activity proposed is categorically excluded from the requirement to prepare an environmental assessment or environmental impact statement.

    Concurrent with the publication of this notice in the Federal Register, NMFS is forwarding copies of the application to the Marine Mammal Commission and its Committee of Scientific Advisors.

    Dated: September 28, 2016. Julia Harrison, Chief, Permits and Conservation Division, Office of Protected Resources, National Marine Fisheries Service.
    [FR Doc. 2016-23933 Filed 10-3-16; 8:45 am] BILLING CODE 3510-22-P
    BUREAU OF CONSUMER FINANCIAL PROTECTION [Docket No. CFPB-2016-0045] Agency Information Collection Activities: Submission for OMB Review; Comment Request AGENCY:

    Bureau of Consumer Financial Protection.

    ACTION:

    Notice and request for comment.

    SUMMARY:

    In accordance with the Paperwork Reduction Act of 1995 (PRA), the Bureau of Consumer Financial Protection (The Bureau) is proposing to renew the Office of Management and Budget (OMB) approval for an existing information collection titled, “Truth in Savings Act (Regulation DD) 12 CFR 1030.”

    DATES:

    Written comments are encouraged and must be received on or before November 3, 2016 to be assured of consideration.

    ADDRESSES:

    You may submit comments, identified by the title of the information collection, OMB Control Number (see below), and docket number (see above), by any of the following methods:

    Electronic: http://www.regulations.gov. Follow the instructions for submitting comments.

    OMB: Office of Management and Budget, New Executive Office Building, Room 10235, Washington, DC 20503 or fax to (202) 395-5806. Mailed or faxed comments to OMB should be to the attention of the OMB Desk Officer for the Bureau of Consumer Financial Protection.

    Please note that comments submitted after the comment period will not be accepted. In general, all comments received will become public records, including any personal information provided. Sensitive personal information, such as account numbers or Social Security numbers, should not be included.

    FOR FURTHER INFORMATION CONTACT:

    Documentation prepared in support of this information collection request is available at www.reginfo.gov (this link becomes active on the day following publication of this notice). Select “Information Collection Review,” under “Currently under review, use the dropdown menu “Select Agency” and select “Consumer Financial Protection Bureau” (recent submissions to OMB will be at the top of the list). The same documentation is also available at http://www.regulations.gov. Requests for additional information should be directed to the Consumer Financial Protection Bureau, (Attention: PRA Office), 1700 G Street NW., Washington, DC 20552, (202) 435-9575, or email: [email protected] Please do not submit comments to this email box.

    SUPPLEMENTARY INFORMATION:

    Title of Collection: Truth in Savings Act (Regulation DD) 12 CFR 1030.

    OMB Control Number: 3170-0004.

    Type of Review: Extension without change of a currently approved information collection.

    Affected Public: Private sector (non-credit union depository institutions).

    Estimated Number of Respondents: 129.

    Estimated Total Annual Burden Hours: 573,008.

    Abstract: Consumers rely on the disclosures required by The Truth in Savings Act (TISA) and Regulation DD to facilitate informed decision-making regarding deposit accounts offered at depository institutions. Without this information, consumers would be severely hindered in their ability to assess the true costs and terms of the deposit accounts offered. Federal agencies and private litigants use the records to ascertain whether accurate and complete disclosures of depository accounts have been provided to consumers. This information also provides the primary evidence of law violations in TISA enforcement actions brought by the Bureau. Without the Regulation DD recordkeeping requirement, the Bureau's ability to enforce the TISA would be significantly impaired.

    Request for Comments: The Bureau issued a 60-day Federal Register notice on June 14, 2016, 81 FR 38691, Docket Number: CFPB-2016-0031. Comments were solicited and continue to be invited on: (a) Whether the collection of information is necessary for the proper performance of the functions of the Bureau, including whether the information will have practical utility; (b) The accuracy of the Bureau's estimate of the burden of the collection of information, including the validity of the methods and the assumptions used; (c) Ways to enhance the quality, utility, and clarity of the information to be collected; and (d) Ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or other forms of information technology. Comments submitted in response to this notice will be summarized and/or included in the request for Office of Management and Budget (OMB) approval. All comments will become a matter of public record.

    Dated: September 28, 2016. Darrin A. King, Paperwork Reduction Act Officer, Bureau of Consumer Financial Protection.
    [FR Doc. 2016-23860 Filed 10-3-16; 8:45 am] BILLING CODE 4810-AM-P
    CORPORATION FOR NATIONAL AND COMMUNITY SERVICE Proposed Information Collection; Comment Request AGENCY:

    Corporation for National and Community Service.

    ACTION:

    Notice.

    SUMMARY:

    The Corporation for National and Community Service (CNCS), as part of its continuing effort to reduce paperwork and respondent burden, conducts a pre-clearance consultation program to provide the general public and federal agencies with an opportunity to comment on proposed and/or continuing collections of information in accordance with the Paperwork Reduction Act of 1995 (PRA95) (44 U.S.C. Sec. 3506(c)(2)(A)). This program helps to ensure that requested data can be provided in the desired format, reporting burden (time and financial resources) is minimized, collection instruments are clearly understood, and the impact of collection requirement on respondents can be properly assessed.

    Currently, CNCS is soliciting comments concerning its proposed use of the AmeriCorps NCCC Project Completion Report. The report is used to collect project assessment and implementation information. Organizations that are awarded and sponsor an AmeriCorps NCCC team will be required to complete this collection instrument.

    Copies of the information collection request can be obtained by contacting the office listed in the Addresses section of this Notice.

    DATES:

    Written comments must be submitted to the individual and office listed in the ADDRESSES section by December 5, 2016.

    ADDRESSES:

    You may submit comments, identified by the title of the information collection activity, by any of the following methods:

    (1) By mail sent to: Corporation for National and Community Service, AmeriCorps NCCC; Attention Terry D. Grant, Program Analyst, 3238-C; 250 E Street SW., Washington, DC 20525.

    (2) By hand delivery or by courier to the CNCS mailroom at the mail address given in paragraph (1) above, between 9:00 a.m. and 4:00 p.m. Eastern Time, Monday through Friday, except Federal holidays.

    (3) Electronically through www.regulations.gov.

    Individuals who use a telecommunications device for the deaf (TTY-TDD) may call 1-800-833-3722 between 8:00 a.m. and 8:00 p.m. Eastern Time, Monday through Friday.

    FOR FURTHER INFORMATION CONTACT:

    Terry D. Grant, 202-606-6899, or by email at [email protected]

    SUPPLEMENTARY INFORMATION:

    CNCS is particularly interested in comments that:

    • Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of CNCS, including whether the information will have practical utility;

    • Evaluate the accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used;

    • Enhance the quality, utility, and clarity of the information to be collected; and

    • Minimize the burden of the collection of information on those who are expected to respond, including the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology (e.g., permitting electronic submissions of responses).

    Background

    Organizations that sponsor an AmeriCorps NCCC team provide the information collected on this form in order to report on the project's implementation and assess the project's scope and community impact.

    Current Action

    This is a new information collection request. The AmeriCorps NCCC Project Completion Report is distributed to organizations that have hosted an NCCC team within 30 days of the end of each project and should be completed within 60 days of the end of each project. Reports are submitted via PDF by email to NCCC staff.

    Type of Review: New.

    Agency: Corporation for National and Community Service.

    Title: AmeriCorps NCCC Project Completion Report.

    OMB Number: None.

    Agency Number: None.

    Affected Public: AmeriCorps NCCC Project Sponsoring Organizations.

    Total Respondents: Approximately 1,000 per year.

    Frequency: Once per project.

    Average Time per Response: Averages 15 minutes.

    Estimated Total Burden Hours: Approximately 300 hours.

    Total Burden Cost (capital/startup): None.

    Total Burden Cost (operating/maintenance): None.

    Comments submitted in response to this notice will be summarized and/or included in the request for Office of Management and Budget approval of the information collection request; they will also become a matter of public record.

    Dated: September 28, 2016. Jacob Sgambati, Director of Operations, NCCC.
    [FR Doc. 2016-23963 Filed 10-3-16; 8:45 am] BILLING CODE 6050-28-P
    DEPARTMENT OF DEFENSE Department of the Navy [Docket ID USN-2015-0005] Proposed Collection; Comment Request AGENCY:

    Department of Navy (DON), DoD.

    ACTION:

    Notice.

    SUMMARY:

    In compliance with the Paperwork Reduction Act of 1995, the Naval Sea Systems Command (NAVSEA), Cost Engineering and Industrial Analysis Group (SEA 05C) announces a proposed public information collection and seeks public comment on the provisions thereof. Comments are invited on: Whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility; the accuracy of the agency's estimate of the burden of the proposed information collection; ways to enhance the quality, utility, and clarity of the information to be collected; and ways to minimize the burden of the information collection on respondents, including through the use of automated collection techniques or other forms of information technology.

    DATES:

    Consideration will be given to all comments received by December 5, 2016.

    ADDRESSES:

    You may submit comments, identified by docket number and title, by any of the following methods:

    Federal eRulemaking Portal: http://www.regulations.gov. Follow the instructions for submitting comments.

    Mail: Department of Defense, Office of the Deputy Chief Management Officer, Directorate for Oversight and Compliance, 4800 Mark Center Drive, Mailbox #24, Alexandria, VA 22350-1700.

    Instructions: All submissions received must include the agency name, docket number and title for this Federal Register document. The general policy for comments and other submissions from members of the public is to make these submissions available for public viewing on the Internet at http://www.regulations.gov as they are received without change, including any personal identifiers or contact information.

    Any associated form(s) for this collection may be located within this same electronic docket and downloaded for review/testing. Follow the instructions at http://www.regulations.gov for submitting comments. Please submit comments on any given form identified by docket number, form number, and title.

    FOR FURTHER INFORMATION CONTACT:

    To request more information on this proposed information collection or to obtain a copy of the proposal and associated collection instruments, please write to the Naval Sea Systems Command (SEA 05C), 1333 Isaac Hull Avenue SE., STOP 1340, Washington Navy Yard, ATTN: Denitra Carter, Washington, DC 20376-1340, at (202) 781-5069.

    SUPPLEMENTARY INFORMATION:

    Title; Associated Form; and OMB Number: Facilities Available for the Construction or Repair of Ships; Standard Form 17; OMB Control Number 0703-0006.

    Needs and Uses: This information collection is part of a joint effort between the Naval Sea Systems Command (NAVSEA) and the U.S. Maritime Administration (MARAD), to maintain a working data set on active U.S. Shipyards. The information collected is required by the Merchant Marine Act of 1936 as amended and is critical in providing both organizations with a comprehensive list of U.S. commercial shipyards and their capabilities and capacities. These shipyards play a crucial role in national defense, the economy and the U.S. transportation infrastructure and as such, are of considerable interest to the U.S. Government. The data collected is used to assess the capabilities and capacities of U.S. commercial shipyards in the areas of ship repair and ship construction. The data is also used to monitor employment numbers for labor forecasting for future build projects as well as providing information on the ability to raise labor to meet national industrial mobilization requirements during times of national emergency. The data collected is the main source of information on these shipyards and is used to these ends.

    Affected Public: Business or other for profit.

    Annual Burden Hours: 800.

    Number of Respondents: 200.

    Responses per Respondent: 1.

    Annual Responses: 200.

    Average Burden per Response: 4 hours.

    Frequency: Annual.

    Respondents are businesses involved in shipbuilding and/or ship repair who provide NAVSEA and MARAD with information and a list of facilities available for the construction or repair of ships that is utilized in a database for assessing the production capacity of the individual shipyards.

    Dated: September 28, 2016. Aaron Siegel, Alternate OSD Federal Register Liaison Officer, Department of Defense.
    [FR Doc. 2016-23861 Filed 10-3-16; 8:45 am] BILLING CODE 5001-06-P
    DEPARTMENT OF ENERGY Federal Energy Regulatory Commission [Docket No. ER16-2675-000] AltaGas Pomona Energy Storage Inc.; Supplemental Notice That Initial Market-Based Rate Filing Includes Request for Blanket Section 204 Authorization

    This is a supplemental notice in the above-referenced proceeding of AltaGas Pomona Energy Storage Inc.s application for market-based rate authority, with an accompanying rate tariff, noting that such application includes a request for blanket authorization, under 18 CFR part 34, of future issuances of securities and assumptions of liability.

    Any person desiring to intervene or to protest should file with the Federal Energy Regulatory Commission, 888 First Street NE., Washington, DC 20426, in accordance with Rules 211 and 214 of the Commission's Rules of Practice and Procedure (18 CFR 385.211 and 385.214). Anyone filing a motion to intervene or protest must serve a copy of that document on the Applicant.

    Notice is hereby given that the deadline for filing protests with regard to the applicant's request for blanket authorization, under 18 CFR part 34, of future issuances of securities and assumptions of liability, is October 18, 2016.

    The Commission encourages electronic submission of protests and interventions in lieu of paper, using the FERC Online links at http://www.ferc.gov. To facilitate electronic service, persons with Internet access who will eFile a document and/or be listed as a contact for an intervenor must create and validate an eRegistration account using the eRegistration link. Select the eFiling link to log on and submit the intervention or protests.

    Persons unable to file electronically should submit an original and 5 copies of the intervention or protest to the Federal Energy Regulatory Commission, 888 First Street NE., Washington, DC 20426.

    The filings in the above-referenced proceeding are accessible in the Commission's eLibrary system by clicking on the appropriate link in the above list. They are also available for electronic review in the Commission's Public Reference Room in Washington, DC. There is an eSubscription link on the Web site that enables subscribers to receive email notification when a document is added to a subscribed docket(s). For assistance with any FERC Online service, please email [email protected], or call (866) 208-3676 (toll free). For TTY, call (202) 502-8659.

    Dated: September 28, 2016. Nathaniel J. Davis, Sr., Deputy Secretary.
    [FR Doc. 2016-23923 Filed 10-3-16; 8:45 am] BILLING CODE 6717-01-P
    DEPARTMENT OF ENERGY Federal Energy Regulatory Commission Combined Notice of Filings #1

    Take notice that the Commission received the following electric corporate filings:

    Docket Numbers: EC16-193-000.

    Applicants: Pioneer Wind Park I LLC.

    Description: Application for Authorization under Section 203 of the Federal Power Act, Request for Expedited Consideration and Confidential Treatment of Pioneer Wind Park I, LLC.

    Filed Date: 9/27/16.

    Accession Number: 20160927-5154.

    Comments Due: 5 p.m. ET 10/18/16.

    Docket Numbers: EC16-194-000.

    Applicants: Brady Wind, LLC, Brady Wind II, LLC, Brady Interconnection, LLC.

    Description: Application for Authorization Under Section 203 of the Federal Power Act and Request for Expedited Action of Brady Wind, LLC, et al.

    Filed Date: 9/27/16.

    Accession Number: 20160927-5159.

    Comments Due: 5 p.m. ET 10/18/16.

    Take notice that the Commission received the following electric rate filings:

    Docket Numbers: ER12-569-012; ER16-2453-001; ER16-2190-001; ER16-2191-001; ER15-1925-005; ER15-2676-004; ER16-1672-001; ER13-712-013; ER10-1849-011; ER11-2037-011; ER12-2227-011; ER10-1887-011; ER10-1920-013; ER10-1928-013; ER10-1952-011; ER10-1961-011; ER12-1228-013; ER16-2275-001; ER16-2276-001; ER14-2707-008; ER12-895-011; ER10-2720-013; ER11-4428-013; ER12-1880-012; ER16-2241-001; ER16-2297-001; ER15-58-006; ER14-2710-008; ER16-1440-002; ER16-2240-001; ER15-30-006; ER14-2708-009; ER14-2709-008; ER13-2474-007; ER11-4462-021; ER10-1971-030.

    Applicants: Blackwell Wind, LLC, Brady Interconnection, LLC, Brady Wind, LLC, Brady Wind II, LLC, Breckinridge Wind Project, LLC, Cedar Bluff Wind, LLC, Chaves County Solar, LLC, Cimarron Wind Energy, LLC, Elk City Wind, LLC, Elk City II Wind, LLC, Ensign Wind, LLC, FPL Energy Cowboy Wind, LLC, FPL Energy Oklahoma Wind, LLC, FPL Energy Sooner Wind, LLC, Gray County Wind Energy, LLC, High Majestic Wind Energy Center, LLC, High Majestic Wind II, LLC, Kingman Wind Energy I, LLC, Kingman Wind Energy II, LLC, Mammoth Plains Wind Project, LLC, Minco Wind Interconnection Services, LLC, Minco Wind, LLC, Minco Wind II, LLC, Minco Wind III, LLC, Ninnescah Wind Energy, LLC, Osborn Wind Energy, LLC, Palo Duro Wind Interconnection Services, LLC, Palo Duro Wind Energy, LLC, Roswell Solar, LLC, Rush Springs Wind Energy, LLC, Seiling Wind Interconnection Services, LLC, Seiling Wind, LLC, Seiling Wind II, LLC, Steele Flats Wind Project, LLC, NEPM II, LLC, NextEra Energy Power Marketing, LLC.

    Description: Notification of Non-material Change in Status of the NextEra Resources Entities, et al.

    Filed Date: 9/27/16.

    Accession Number: 20160927-5161.

    Comments Due: 5 p.m. ET 10/18/16.

    Docket Numbers: ER16-1363-001.

    Applicants: Arizona Public Service Company.

    Description: Compliance filing: Compliance Filing of Arizona Public Service Company to be effective 9/30/2016.

    Filed Date: 9/28/16.

    Accession Number: 20160928-5097.

    Comments Due: 5 p.m. ET 10/19/16.

    Docket Numbers: ER16-2023-001.

    Applicants: California Independent System Operator Corporation.

    Description: Compliance filing: 2016-09-28 Waiver Petition Delay Implementation of Flexible Ramping Product to be effective. N/A.

    Filed Date: 9/28/16.

    Accession Number: 20160928-5146.

    Comments Due: 5 p.m. ET 10/19/16.

    Docket Numbers: ER16-2467-001.

    Applicants: NSTAR Electric Company.

    Description: Tariff Amendment: Amendment—Notice of Cancellation of Exelon West Medway Design-Engineering Agmt to be effective 6/14/2016.

    Filed Date: 9/28/16.

    Accession Number: 20160928-5113.

    Comments Due: 5 p.m. ET 10/19/16.

    Docket Numbers: ER16-2676-000.

    Applicants: PacifiCorp.

    Description: Notice of Termination of LGIA SA 309 of PacifiCorp.

    Filed Date: 9/27/16.

    Accession Number: 20160927-5158.

    Comments Due: 5 p.m. ET 10/18/16.

    Docket Numbers: ER16-2677-000.

    Applicants: Southwest Power Pool, Inc.

    Description: § 205(d) Rate Filing: 3215R1 People's Electric Cooperative NITSA NOA to be effective 8/1/2016.

    Filed Date: 9/28/16.

    Accession Number: 20160928-5051.

    Comments Due: 5 p.m. ET 10/19/16.

    Docket Numbers: ER16-2678-000.

    Applicants: Nevada Power Company.

    Description: § 205(d) Rate Filing: OATT Revisions TOC, Definitions and Attachment P to be effective 11/1/2016.

    Filed Date: 9/28/16.

    Accession Number: 20160928-5057.

    Comments Due: 5 p.m. ET 10/19/16.

    Docket Numbers: ER16-2679-000.

    Applicants: Terrapin Energy LLC.

    Description: § 205(d) Rate Filing: Certificate of Concurrence Filing to be effective 9/20/2016.

    Filed Date: 9/28/16.

    Accession Number: 20160928-5059.

    Comments Due: 5 p.m. ET 10/19/16.

    Docket Numbers: ER16-2680-000.

    Applicants: PacifiCorp.

    Description: § 205(d) Rate Filing: OATT Revisions (Flexible Ramping Requirement) to be effective 11/1/2016.

    Filed Date: 9/28/16.

    Accession Number: 20160928-5067.

    Comments Due: 5 p.m. ET 10/19/16.

    Docket Numbers: ER16-2681-000.

    Applicants: Southwest Power Pool, Inc.

    Description: § 205(d) Rate Filing: Revisions to Attachment AE to Remove Interim TCR Process to be effective 11/28/2016.

    Filed Date: 9/28/16.

    Accession Number: 20160928-5149.

    Comments Due: 5 p.m. ET 10/19/16.

    Docket Numbers: ER16-2682-000.

    Applicants: PJM Interconnection, L.L.C.

    Description: § 205(d) Rate Filing: Second Revised ISA No. 3669, Queue No. Y3-046/Y3-051/Z1-058/Z2-059/Z2-002 to be effective 8/29/2016.

    Filed Date: 9/28/16.

    Accession Number: 20160928-5150.

    Comments Due: 5 p.m. ET 10/19/16.

    Docket Numbers: ER16-2683-000.

    Applicants: El Paso Electric Company.

    Description: Compliance filing: OATT Order No. 827 and 828 Compliance Filing to be effective 10/14/2016.

    Filed Date: 9/28/16.

    Accession Number: 20160928-5155.

    Comments Due: 5 p.m. ET 10/19/16.

    The filings are accessible in the Commission's eLibrary system by clicking on the links or querying the docket number.

    Any person desiring to intervene or protest in any of the above proceedings must file in accordance with Rules 211 and 214 of the Commission's Regulations (18 CFR 385.211 and 385.214) on or before 5:00 p.m. Eastern time on the specified comment date. Protests may be considered, but intervention is necessary to become a party to the proceeding.

    eFiling is encouraged. More detailed information relating to filing requirements, interventions, protests, service, and qualifying facilities filings can be found at: http://www.ferc.gov/docs-filing/efiling/filing-req.pdf. For other information, call (866) 208-3676 (toll free). For TTY, call (202) 502-8659.

    Dated: September 28, 2016. Nathaniel J. Davis, Sr., Deputy Secretary.
    [FR Doc. 2016-23921 Filed 10-3-16; 8:45 am] BILLING CODE 6717-01-P
    DEPARTMENT OF ENERGY Federal Energy Regulatory Commission Combined Notice of Filings

    Take notice that the Commission has received the following Natural Gas Pipeline Rate and Refund Report filings:

    Filings Instituting Proceedings

    Docket Numbers: RP16-1244-000.

    Applicants: Enable Mississippi River Transmission, L.

    Description: § 4(d) Rate Filing: 2016 Fuel Adjustment Filing to be effective 11/1/2016.

    Filed Date: 9/23/16.

    Accession Number: 20160923-5124.

    Comments Due: 5 p.m. ET 10/5/16.

    Docket Numbers: RP16-1245-000.

    Applicants: Enable Gas Transmission, LLC.

    Description: § 4(d) Rate Filing: Fuel Tracker Filing Effective November 1 2016 to be effective 11/1/2016.

    Filed Date: 9/23/16.

    Accession Number: 20160923-5138.

    Comments Due: 5 p.m. ET 10/5/16.

    Docket Numbers: RP16-1246-000.

    Applicants: Kern River Gas Transmission Company.

    Description: § 4(d) Rate Filing: 2016 Misc Updates Orig Vol 1A to be effective 10/24/2016.

    Filed Date: 9/23/16.

    Accession Number: 20160923-5159.

    Comments Due: 5 p.m. ET 10/5/16.

    Docket Numbers: RP16-1247-000.

    Applicants: Trunkline Gas Company, LLC.

    Description: Compliance filing Annual Report of Flow Through filed 9-23-16.

    Filed Date: 9/23/16.

    Accession Number: 20160923-5171.

    Comments Due: 5 p.m. ET 10/5/16.

    Docket Numbers: RP16-1248-000.

    Applicants: Alliance Pipeline L.P.

    Description: § 4(d) Rate Filing: Fuel Requirement Nov 2016 to be effective 11/1/2016.

    Filed Date: 9/23/16.

    Accession Number: 20160923-5172.

    Comments Due: 5 p.m. ET 10/5/16.

    Docket Numbers: RP16-1249-000.

    Applicants: Transcontinental Gas Pipe Line Company.

    Description: § 4(d) Rate Filing: Imbalance Calculations to be effective 11/1/2016.

    Filed Date: 9/23/16.

    Accession Number: 20160923-5198.

    Comments Due: 5 p.m. ET 10/5/16.

    Any person desiring to intervene or protest in any of the above proceedings must file in accordance with Rules 211 and 214 of the Commission's Regulations (18 CFR 385.211 and § 385.214) on or before 5:00 p.m. Eastern time on the specified comment date. Protests may be considered, but intervention is necessary to become a party to the proceeding.

    Filings in Existing Proceedings

    Docket Numbers: RP16-618-001.

    Applicants: Algonquin Gas Transmission, LLC.

    Description: Compliance filing Capacity Release Bidding Exemption—Compliance Filing to be effective 9/1/2016.

    Filed Date: 9/23/16.

    Accession Number: 20160923-5153.

    Comments Due: 5 p.m. ET 10/5/16.

    Docket Numbers: RP16-1178-001.

    Applicants: Equitrans, L.P.

    Description: Compliance filing Ohio Valley Connector Errata Filing to be effective 12/31/9998.

    Filed Date: 9/26/16.

    Accession Number: 20160926-5085.

    Comments Due: 5 p.m. ET 10/11/16.

    Any person desiring to protest in any of the above proceedings must file in accordance with Rule 211 of the Commission's Regulations (18 CFR 385.211) on or before 5:00 p.m. Eastern time on the specified comment date.

    The filings are accessible in the Commission's eLibrary system by clicking on the links or querying the docket number.

    eFiling is encouraged. More detailed information relating to filing requirements, interventions, protests, service, and qualifying facilities filings can be found at: http://www.ferc.gov/docs-filing/efiling/filing-req.pdf. For other information, call (866) 208-3676 (toll free). For TTY, call (202) 502-8659.

    Dated: September 26, 2016. Nathaniel J. Davis, Sr., Deputy Secretary.
    [FR Doc. 2016-23922 Filed 10-3-16; 8:45 am] BILLING CODE 6717-01-P
    ENVIRONMENTAL PROTECTION AGENCY [EPA-HQ-OAR-2010-0505; FRL-9953-57-OAR] Clarification of Reconsideration of the Oil and Natural Gas Sector: New Source Performance Standards; Final Action AGENCY:

    Environmental Protection Agency (EPA).

    ACTION:

    Notice of supplemental action denying petitions for reconsideration.

    SUMMARY:

    The U.S. Environmental Protection Agency (EPA) is providing notice that it has clarified the scope of its July 29, 2016, response to petitions for reconsideration of the 2012 final rule titled “Oil and Natural Gas Sector: New Source Performance Standards and National Emission Standards for Hazardous Air Pollutants Reviews” and the subsequent amendments published in the Federal Register on September 23, 2013, and December 31, 2014. The EPA has sent a letter to each of the petitioners clarifying that the July 29, 2016, action denied the above mentioned petitions only with respect to the issues related to the new source performance standards (NSPS), and was not intended to include denial of reconsideration of any issue relative to the 2012 action on the national emission standards for hazardous air Pollutants (“2012 NESHAP”). The letters further state that, to the extent the July 29, 2016, action may be construed to have denied reconsideration of issues relative to the 2012 NESHAP, the follow-up letters supersede that previous action on NESHAP-related matters.

    DATES:

    Effective October 4, 2016.

    FOR FURTHER INFORMATION CONTACT:

    Ms. Lisa Thompson, Sector Policies and Programs Division (E143-05), Office of Air Quality Planning and Standards, Environmental Protection Agency, Research Triangle Park, North Carolina 27711; telephone number: (919) 541-9775; fax number: (919) 541-3470; email address: [email protected]

    SUPPLEMENTARY INFORMATION:

    I. Where can I get a copy of this document and other related information?

    A copy of this Federal Register notice, the supplemental letters, and the revised supporting document describing the full basis for the July 29, 2016, action are available in the docket the EPA established under Docket ID No. EPA-HQ-OAR-2010-0505. In addition, following signature, all relevant documents will be available on the World Wide Web (WWW) at the following address: https://www3.epa.gov/airquality/oilandgas/actions.html.

    II. Description of Action

    On August 16, 2012, the EPA published the final rule titled “Oil and Natural Gas Sector: New Source Performance Standards and National Emission Standards for Hazardous Air Pollutants Reviews.” See 77 FR 49490. The rule contains final actions on two different national standards for the oil and natural gas sector: (1) NSPS, promulgated under section 111 of the Clean Air Act (CAA) and (2) NESHAP, promulgated under section 112 of the CAA. The 2012 rule was followed by a series of reconsideration actions and amendments to the 2012 NSPS. 78 FR 58416 (September 23, 2013); 79 FR 79018 (December 31, 2014); 80 FR 48262 (August 12, 2015); and 81 FR 35824 (June 3, 2016) (“2016 Final Rule”). The EPA received administrative petitions for reconsideration of the 2012 rules (on both the NSPS and the NESHAP), as well as for reconsideration of the 2013 and 2014 NSPS amendments. On July 29, 2016, the Administrator took final action denying these petitions with respect to NSPS issues not otherwise addressed in prior reconsideration actions. That action was announced in a Federal Register notice published on August 10, 2016 (81 FR 52778). Although several of the reconsideration petitions identified in the July 29, 2016, action also include NESHAP issues, and one petition pertains only to the 2012 NESHAP,1 the EPA did not address the substance of any NESHAP related issues in that action.

    1 Petition for Reconsideration of Oil and Natural Gas Sector: National Emission Standards for Hazardous Air Pollutants Reviews; Final Rule, 77 FR 49490 (August 16, 2012), 40 CFR part 63, subparts HH and HHH, submitted by Earthjustice on behalf of California Communities Against Toxics, California Safe Schools, Clean Air Council, Coalition For A Safe Environment, Desert Citizens Against Pollution, Natural Resources Defense Council, and Sierra Club (October 15, 2012).

    The EPA is providing notice that it has issued a supplemental letter to clarify the scope of its July 29, 2016, action. The supplemental letter further clarifies that the July 29, 2016, action was not intended to include denial of reconsideration of any issue relative to the 2012 NESHAP and that the EPA continues to evaluate reconsideration issues relative to the 2012 NESHAP. The letter also states that, to the extent the July 29, 2016, letter may be construed to have denied reconsideration of issues relative to the 2012 NESHAP, the supplemental letter supersedes that action on NESHAP-related issues.

    Enclosed with the supplemental letter is a revised document titled “Denial of Petitions for Reconsideration of Certain Issues: Oil and Natural Gas New Source Performance Standards (40 CFR part 60, subpart OOOO).” The document sets forth the EPA's reasons for denying the above mentioned petitions with respect to NSPS issues not otherwise addressed in previous reconsideration actions. The NSPS reconsideration denial supporting document that accompanied the July 29, 2016 letters has been revised to remove two erroneous references: (1) Replaced No. 4591 with No. 4575 as the Petitioner for Issue 26; and (2) removed No. 4591 from the list of NSPS Petitioners in Appendix A.

    Dated: September 26, 2016. Janet G. McCabe, Acting Assistant Administrator, Office of Air and Radiation.
    [FR Doc. 2016-23972 Filed 10-3-16; 8:45 am] BILLING CODE 6560-50-P
    ENVIRONMENTAL PROTECTION AGENCY [EPA-HQ-OECA-2007-0468; ER-FRL-9029-4] Proposed Information Collection Request; Comment Request; Final Rule at 40 CFR Part 8: Environmental Impact Assessment of Nongovernmental Activities in Antarctica (Renewal) AGENCY:

    Environmental Protection Agency (EPA).

    ACTION:

    Notice.

    SUMMARY:

    The Environmental Protection Agency is planning to submit an information collection request (ICR), “Final Rule at 40 CFR part 8: Environmental Impact Assessment of Nongovernmental Activities in Antarctica” (EPA ICR No. 1808.07, OMB Control No. 2020-0007) to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act (44 U.S.C. 3501 et seq.). Before doing so, EPA is soliciting public comments on specific aspects of the proposed information collection as described below. This is a proposed extension of the ICR, which is currently approved through March 31, 2017. An Agency may not conduct or sponsor and a person is not required to respond to a collection of information unless it displays a currently valid OMB control number.

    DATES:

    Comments must be submitted on or before Monday, December 5, 2016.

    ADDRESSES:

    Submit your comments, referencing Docket ID No. EPA-HQ-OECA-2007-0468 online using www.regulations.gov (our preferred method) or by mail to: EPA Docket Center, Environmental Protection Agency, Mail Code 28221T, 1200 Pennsylvania Ave. NW., Washington, DC 20460.

    EPA's policy is that all comments received will be included in the public docket without change including any personal information provided, unless the comment includes profanity, threats, information claimed to be Confidential Business Information (CBI) or other information whose disclosure is restricted by statute.

    FOR FURTHER INFORMATION CONTACT:

    Julie Roemele, Office of Federal Activities, Mail Code 2252A, Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460; telephone number: (202) 564-5632; fax number: (202) 564-0072; email address: [email protected]

    SUPPLEMENTARY INFORMATION:

    Supporting documents which explain in detail the information that the EPA will be collecting are available in the public docket for this ICR. The docket can be viewed online at www.regulations.gov or in person at the EPA Docket Center, WJC West, Room 3334, 1301 Constitution Ave. NW., Washington, DC. The telephone number for the Docket Center is 202-566-1744. For additional information about EPA's public docket, visit http://www.epa.gov/dockets.

    Pursuant to section 3506(c)(2)(A) of the PRA, EPA is soliciting comments and information to enable it to: (i) Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the Agency, including whether the information will have practical utility; (ii) evaluate the accuracy of the Agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (iii) enhance the quality, utility, and clarity of the information to be collected; and (iv) minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated electronic, mechanical, or other technological collection techniques or other forms of information technology, e.g., permitting electronic submission of responses. EPA will consider the comments received and amend the ICR as appropriate. The final ICR package will then be submitted to OMB for review and approval. At that time, EPA will issue another Federal Register notice to announce the submission of the ICR to OMB and the opportunity to submit additional comments to OMB.

    Abstract: The Environmental Protection Agency's (EPA's) regulations at 40 CFR part 8, Environmental Impact Assessment of Nongovernmental Activities in Antarctica (Rule), were promulgated pursuant to the Antarctic Science, Tourism, and Conservation Act of 1996 (Act), 16 U.S.C. 2401 et seq., as amended, 16 U.S.C. 2403a, which implements the Protocol on Environmental Protection (Protocol) to the Antarctic Treaty of 1959 (Treaty). The Rule provides for assessment of the environmental impacts of nongovernmental activities in Antarctica, including tourism, for which the United States is required to give advance notice under Paragraph 5 of Article VII of the Treaty, and for coordination of the review of information regarding environmental impact assessments received from other Parties under the Protocol. The requirements of the Rule apply to operators of nongovernmental expeditions organized or proceeding from the territory of the United States to Antarctica and include commercial and non-commercial expeditions. Expeditions may include ship-based tours; yacht, skiing or mountaineering expeditions; privately funded research expeditions; and other nongovernmental activities. The Rule does not apply to individual U.S. citizens or groups of citizens planning travel to Antarctica on an expedition for which they are not acting as an operator. (Operators, for example, typically acquire use of vessels or aircraft, hire expedition staff, plan itineraries, and undertake other organizational responsibilities.) The rule provides nongovernmental operators with the specific requirements they need to meet in order to comply with the requirements of Article 8 and Annex I to the Protocol. The provisions of the Rule are intended to ensure that potential environmental effects of nongovernmental activities undertaken in Antarctica are appropriately identified and considered by the operator during the planning process and that to the extent practicable appropriate environmental safeguards which would mitigate or prevent adverse impacts on the Antarctic environment are identified by the operator.

    Environmental Documentation. Persons subject to the Rule must prepare environmental documentation to support the operator's determination regarding the level of environmental impact of the proposed expedition. Environmental documentation includes a Preliminary Environmental Review Memorandum (PERM), an Initial Environmental Evaluation (IEE), or a Comprehensive Environmental Evaluation (CEE). The environmental document is submitted to the Office of Federal Activities (OFA). If the operator determines that an expedition may have: (1) Less than a minor or transitory impact, a PERM needs to be submitted no later than 180 days before the proposed departure to Antarctica; (2) no more than minor or transitory impacts, an IEE needs to be submitted no later than 90 days before the proposed departure; or (3) more than minor or transitory impacts, a CEE needs to be submitted. Operators who anticipate such activities are encouraged to consult with EPA as soon as possible regarding the date for submittal of the CEE. (Article 3(4), of Annex I of the Protocol requires that draft CEEs be distributed to all Parties and the Committee for Environmental Protection 120 days in advance of the next Antarctic Treaty Consultative Meeting (ATCM) at which the CEE may be addressed.)

    The Protocol and the Rule also require an operator to employ procedures to assess and provide a regular and verifiable record of the actual impacts of an activity which proceeds on the basis of an IEE or CEE. The record developed through these measures needs to be designed to: (a) Enable assessments to be made of the extent to which environmental impacts of nongovernmental expeditions are consistent with the Protocol; and (b) provide information useful for minimizing and mitigating those impacts and, where appropriate, on the need for suspension, cancellation, or modification of the activity. Moreover, an operator needs to monitor key environmental indicators for an activity proceeding on the basis of a CEE. An operator may also need to carry out monitoring in order to assess and verify the impact of an activity for which an IEE would be prepared. For activities that require an IEE, an operator should be able to use procedures currently being voluntarily utilized by operators to provide the required information. Should an activity require a CEE, the operator should consult with EPA to: (a) Identify the monitoring regime appropriate to that activity, and (b) determine whether and how the operator might utilize relevant monitoring data collected by the U.S. Antarctic Program. The Office of Federal Activities (OFA) would consult with the National Science Foundation and other interested Federal agencies regarding the monitoring regime.

    In cases of emergency related to the safety of human life or of ships, aircraft, equipment and facilities of high value, or the protection of the environment which would require an activity to be undertaken without completion of the documentation procedures set out in the Rule, the operator would need to notify the Department of State within 15 days of any activities which would have otherwise required preparation of a CEE, and provide a full explanation of the activities carried out within 45 days of those activities. (During the time the Interim Final and Final Rules have been in effect, there were no emergencies requiring notification by U.S. operators. An Interim Final Rule was in effect from April 30, 1997, until replaced on December 6, 2001, by the Final Rule).

    Environmental documents (e.g., PERM, IEE, CEE) are submitted to OFA. Environmental documents are reviewed by OFA, in consultation with the National Science Foundation and other interested Federal agencies, and also made available to other Parties and the public as required under the Protocol or otherwise requested. OFA notifies the public of document availability via the World Wide Web at: https://www.epa.gov/international-cooperation/receipt-environmental-impact-assessments-eias-regarding-nongovernmental.

    The types of nongovernmental activities currently being carried out (e.g., ship-based tours, land-based tours, flights, and privately funded research expeditions) are typically unlikely to have impacts that are more than minor or transitory, thus an IEE is the typical level of environmental documentation submitted. For the 1997-1998 through 2015-2016 austral summer seasons during the time the Rule has been in effect, all respondents submitted IEEs with the exception of three PERMs. Paperwork reduction provisions in the Rule that are used by the operators include: (a) Incorporation of material in the environmental document by referring to it in the IEE, (b) inclusion of all proposed expeditions by one operator within one IEE; (c) use of one IEE to address expeditions being carried out by more than one operator; and (d) use of multi-year environmental documentation to address proposed expeditions for a period of up to five consecutive austral summer seasons.

    Coordination of Review of Information Received from Other Parties to the Treaty. The Rule also provides for the coordination of review of information received from other Parties and the public availability of that information including: (1) A description of national procedures for considering the environmental impacts of proposed activities; (2) an annual list of any IEEs and any decisions taken in consequence thereof; (3) significant information obtained and any action taken in consequence thereof with regard to monitoring from IEEs to CEEs; and (4) information in a final CEE. This provision fulfills the United States' obligation to meet the requirements of Article 6 of Annex I to the Protocol. The Department of State is responsible for coordination of these reviews of drafts with interested Federal agencies, and for public availability of documents and information. This portion of the Rule does not impose paperwork requirements on any nongovernmental person subject to U.S. regulation.

    Form Numbers: None.

    Respondents/affected entities: Entities potentially affected by this action are all nongovernmental operators with activities in Antarctica, including tour operators, for which the United States is required to give advance notice under paragraph 5 of Article VII of the Antarctic Treaty of 1959; this includes all nongovernmental expeditions to and within Antarctica organized in or proceeding from the territory of the United States.

    Respondent's obligation to respond: Mandatory (40 CFR part 8).

    Estimated number of respondents: 19.

    Frequency of response: Annual.

    Total estimated burden: 1,273 hours.

    Total estimated cost: $103,891 includes $3,353 annualized capital or operation & maintenance costs.

    Changes in Estimates: There is an increase of 19 hours in the total estimated respondent burden compared with the ICR currently approved by OMB. This increase is the result of a change to the level of environmental documentation EPA anticipates the operators will submit as well as an anticipated increase in the number of operators submitting documentation.

    Dated: September 29, 2016. Karin Leff, Acting Director, NEPA Compliance Division, Office of Federal Activities.
    [FR Doc. 2016-23982 Filed 10-3-16; 8:45 am] BILLING CODE P
    ENVIRONMENTAL PROTECTION AGENCY [FRL-9953-67-OA] Notification of a Public Meeting of the Clean Air Scientific Advisory Committee (CASAC) Oxides of Nitrogen Primary NAAQS Review Panel AGENCY:

    Environmental Protection Agency (EPA).

    ACTION:

    Notice.

    SUMMARY:

    The EPA Science Advisory Board (SAB) Staff Office announces a public meeting of the Clean Air Scientific Advisory Committee (CASAC) Oxides of Nitrogen Primary National Ambient Air Quality Standards (NAAQS) Review Panel to peer review EPA's Policy Assessment for the Review of the Primary National Ambient Air Quality Standards for Nitrogen Dioxide (External Review Draft—September 2016).

    DATES:

    The CASAC Oxides of Nitrogen Primary NAAQS Review Panel meeting will be on Wednesday, November 9, 2016 from 9:00 a.m. to 5:00 p.m. (Eastern Time) and on Thursday, November 10, 2016 from 8:30 a.m. to 12:30 p.m. (Eastern Time).

    LOCATION:

    The public meeting will be held at the Embassy Suites by Hilton Alexandria Old Town, 1900 Diagonal Road, Alexandria, Virginia 22314.

    FOR FURTHER INFORMATION CONTACT:

    Any member of the public wishing to obtain information concerning the public meeting may contact Mr. Aaron Yeow, Designated Federal Officer (DFO), EPA Science Advisory Board Staff Office (1400R), U.S. Environmental Protection Agency, 1200 Pennsylvania Avenue NW., Washington, DC 20460; by telephone at (202) 564-2050 or via email at [email protected] General information about the CASAC, as well as any updates concerning the meeting announced in this notice, may be found on the CASAC Web site at http://www.epa.gov/casac.

    SUPPLEMENTARY INFORMATION:

    The CASAC was established pursuant to the Clean Air Act (CAA) Amendments of 1977, codified at 42 U.S.C. 7409(d)(2), to review air quality criteria and NAAQS and recommend any new NAAQS and revisions of existing criteria and NAAQS as may be appropriate. The CASAC shall also provide advice, information, and recommendations to the Administrator on the scientific and technical aspects of issues related to the criteria for air quality standards, research related to air quality, sources of air pollution, and of adverse effects which may result from various strategies to attain and maintain air quality standards. The CASAC is a Federal Advisory Committee chartered under the Federal Advisory Committee Act (FACA), 5 U.S.C., App. 2. Section 109(d)(1) of the CAA requires that the Agency periodically review and revise, as appropriate, the air quality criteria and the NAAQS for the six “criteria” air pollutants, including oxides of nitrogen. EPA is currently reviewing the primary (health-based) NAAQS for nitrogen dioxide (NO2) as an indicator for health effects caused by the presence of oxides of nitrogen in the ambient air.

    Pursuant to FACA and EPA policy, notice is hereby given that the CASAC Oxides of Nitrogen Primary NAAQS Review Panel will hold a public meeting to peer review EPA's Policy Assessment for the Review of the Primary National Ambient Air Quality Standards for Nitrogen Dioxide (External Review Draft—September 2016). The CASAC Oxides of Nitrogen Primary NAAQS Review Panel and the CASAC will comply with the provisions of FACA and all appropriate SAB Staff Office procedural policies.

    Technical Contacts: Any technical questions concerning the Policy Assessment for the Review of the Primary National Ambient Air Quality Standards for Nitrogen Dioxide (External Review Draft—September 2016) should be directed to Dr. Jennifer Nichols ([email protected]), EPA Office of Air and Radiation.

    Availability of Meeting Materials: Prior to the meeting, the review documents, agenda and other materials will be accessible on the CASAC Web site at http://www.epa.gov/casac/.

    Procedures for Providing Public Input: Public comment for consideration by EPA's federal advisory committees and panels has a different purpose from public comment provided to EPA program offices. Therefore, the process for submitting comments to a federal advisory committee is different from the process used to submit comments to an EPA program office.

    Federal advisory committees and panels, including scientific advisory committees, provide independent advice to EPA. Members of the public can submit relevant comments on the topic of this advisory activity, including the charge to the panel and the EPA review documents, and/or the group conducting the activity, for the CASAC to consider during the advisory process. Input from the public to the CASAC will have the most impact if it provides specific scientific or technical information or analysis for CASAC panels to consider or if it relates to the clarity or accuracy of the technical information. Members of the public wishing to provide comment should contact the DFO directly.

    Oral Statements: In general, individuals or groups requesting an oral presentation at a public meeting will be limited to five minutes. Each person making an oral statement should consider providing written comments as well as their oral statement so that the points presented orally can be expanded upon in writing. Interested parties should contact Mr. Aaron Yeow, DFO, in writing (preferably via email) at the contact information noted above by November 2, 2016, to be placed on the list of public speakers. Written Statements: Written statements will be accepted throughout the advisory process; however, for timely consideration by Panel members, statements should be supplied to the DFO (preferably via email) at the contact information noted above by November 2, 2016. It is the SAB Staff Office general policy to post written comments on the Web page for the advisory meeting or teleconference. Submitters are requested to provide an unsigned version of each document because the SAB Staff Office does not publish documents with signatures on its Web sites. Members of the public should be aware that their personal contact information, if included in any written comments, may be posted to the CASAC Web site. Copyrighted material will not be posted without explicit permission of the copyright holder.

    Accessibility: For information on access or services for individuals with disabilities, please contact Mr. Aaron Yeow at the contact information provided above. To request accommodation of a disability, please contact Mr. Yeow preferably at least ten days prior to each meeting to give EPA as much time as possible to process your request.

    Dated: September 28, 2016. Khanna Johnston, Acting Deputy Director, EPA Science Advisory Staff Office.
    [FR Doc. 2016-23974 Filed 10-3-16; 8:45 am] BILLING CODE 6560-50-P
    ENVIRONMENTAL PROTECTION AGENCY [FRL-9953-70-ORD] Human Studies Review Board; Notification of Public Meetings AGENCY:

    Environmental Protection Agency (EPA).

    ACTION:

    Notice.

    SUMMARY:

    The Environmental Protection Agency (EPA) Office of the Science Advisor announces two separate public meetings of the Human Studies Review Board (HSRB) to advise the Agency on the ethical and scientific review of research involving human subjects.

    DATES:

    A public virtual meeting will be held on October 19-20, 2016, from 1:00 p.m. to approximately 5:00 p.m. Eastern Time each day. A separate, subsequent teleconference meeting is planned for Tuesday, December 13, 2016, from 2:00 p.m. to approximately 3:30 p.m. for the HSRB to finalize its Final Report of the October 19-20, 2016 meeting.

    ADDRESSES:

    Both of these meetings will be conducted entirely by telephone and on the Internet using Adobe Connect. For detailed access information visit the HSRB Web site: http://www2.epa.gov/osa/human-studies-review-board.

    FOR FURTHER INFORMATION CONTACT:

    Any member of the public who wishes to receive further information should contact the HSRB Designated Federal Official, Jim Downing on telephone number (202) 564-2468; fax number: (202) 564-2070; email address: [email protected]; or mailing address: Environmental Protection Agency, Office of the Science Advisor, Mail code 8105R, 1200 Pennsylvania Avenue NW., Washington, DC 20460.

    SUPPLEMENTARY INFORMATION:

    Meeting access: These meetings are open to the public. Meeting materials are available at the HSRB Web site: http://www2.epa.gov/osa/human-studies-review-board for questions on document availability, or if you do not have access to the Internet, consult with Jim Downing listed under FOR FURTHER INFORMATION CONTACT.

    Special accommodations. For information on access or services for individuals with disabilities, or to request accommodation of a disability, please contact Jim Downing listed under FOR FURTHER INFORMATION CONTACT at least 10 days prior to the meeting to give EPA as much time as possible to process your request.

    How may I participate in this meeting?

    The HSRB encourages the public's input. You may participate in these meetings by following the instructions in this section.

    1. Oral comments. Requests to present oral comments during either conference call will be accepted up to Noon Eastern Time on Wednesday, October 12, 2016, for the October 19-20, 2016 meeting and up to Noon Eastern Time on Thursday, December 8, 2016 for the December 13, 2016 conference call. To the extent that time permits, interested persons who have not pre-registered may be permitted by the HSRB Chair to present oral comments during either call at the designated time on the agenda. Oral comments before the HSRB are generally limited to five minutes per individual or organization. If additional time is available, further public comments may be possible.

    2. Written comments. Submit your written comments prior to the meetings. For the Board to have the best opportunity to review and consider your comments as it deliberates, you should submit your comments by Noon Eastern Time on Wednesday, October 12, 2016, for the October 19-20, 2016 conference call, and by noon Eastern Time on Thursday, December 8, 2016 for the December 13, 2016 teleconference. If you submit comments after these dates, those comments will be provided to the HSRB members, but you should recognize that the HSRB members may not have adequate time to consider your comments prior to their discussion. You should submit your comments to Jim Downing listed under FOR FURTHER INFORMATION CONTACT. There is no limit on the length of written comments for consideration by the HSRB.

    Background

    The HSRB is a Federal advisory committee operating in accordance with the Federal Advisory Committee Act 5 U.S.C. App. 2 § 9. The HSRB provides advice, information, and recommendations on issues related to scientific and ethical aspects of human subjects research that are submitted to the Office of Pesticide Programs to be used for regulatory purposes. The major objectives of the HSRB are to provide advice and recommendations on: (1) Research proposals and protocols; (2) reports of completed research with human subjects; and (3) how to strengthen EPA's programs for protection of human subjects of research.

    Topics for discussion. On Wednesday, October 19, 2016, EPA's Human Studies Review Board will consider a Protocol for Laboratory Evaluation of Mosquito Bite Protection from Permethrin-treated Clothing for the U.S. Army after 0, 20 and/or 50 washings. On Thursday, October 20, 2016 the HSRB will consider: A Study for Measurement of Potential Dermal and Inhalation Exposure during Manual Pouring of Two Solid Formulations Containing an Antimicrobial. Meeting materials for these two topics will be available in advance of the meeting at http://www2.epa.gov/osa/human-studies-review-board.

    On December 13, 2016, the Human Studies Review Board will review and finalize their draft Final Report from the October 19-20, 2016 meeting. The draft report will be available prior to the conference call at http://www2.epa.gov/osa/human-studies-review-board.

    Meeting minutes and final reports. Minutes of these meetings, summarizing the matters discussed and recommendations made by the HSRB, will be released within 90 calendar days of the meeting. These minutes will be available at http://www2.epa.gov/osa/human-studies-review-board. In addition, information regarding the HSRB's Final Report, will be found at http://www2.epa.gov/osa/human-studies-review-board or from Jim Downing listed under FOR FURTHER INFORMATION CONTACT.

    Thomas A. Burke, EPA Science Advisor.
    [FR Doc. 2016-23987 Filed 10-3-16; 8:45 am] BILLING CODE 6560-50-P
    FEDERAL COMMUNICATIONS COMMISSION [OMB 3060-1079] Information Collection Being Reviewed by the Federal Communications Commission Under Delegated Authority AGENCY:

    Federal Communications Commission.

    ACTION:

    Notice and request for comments.

    SUMMARY:

    As part of its continuing effort to reduce paperwork burdens, and as required by the Paperwork Reduction Act (PRA) of 1995 (44 U.S.C. 3501-3520), the Federal Communications Commission (FCC or Commission) invites the general public and other Federal agencies to take this opportunity to comment on the following information collections. Comments are requested concerning: Whether the proposed collection of information is necessary for the proper performance of the functions of the Commission, including whether the information shall have practical utility; the accuracy of the Commission's burden estimate; ways to enhance the quality, utility, and clarity of the information collected; ways to minimize the burden of the collection of information on the respondents, including the use of automated collection techniques or other forms of information technology; and ways to further reduce the information collection burden on small business concerns with fewer than 25 employees. The FCC may not conduct or sponsor a collection of information unless it displays a currently valid OMB control number. No person shall be subject to any penalty for failing to comply with a collection of information subject to the PRA that does not display a valid OMB control number.

    DATES:

    Written PRA comments should be submitted on or before December 5, 2016. If you anticipate that you will be submitting comments, but find it difficult to do so within the period of time allowed by this notice, you should advise the contact listed below as soon as possible.

    ADDRESSES:

    Direct all PRA comments to Nicole Ongele, FCC, via email to [email protected] and to [email protected]

    FOR FURTHER INFORMATION CONTACT:

    For additional information about the information collection, contact Nicole Ongele at (202) 418-2991.

    SUPPLEMENTARY INFORMATION:

    OMB Control Number: 3060-1079.

    Title: Section 15.240, Radio Frequency Identification Equipment.

    Type of Review: Extension of a currently approved collection.

    Form No.: N/A.

    Respondents: Business or other for-profit and not-for-profit institutions.

    Number of Respondents and Responses: 10 respondents; 20 responses.

    Estimated Time per Response: 2 hours.

    Frequency of Response: On occasion reporting requirement and third party disclosure requirements.

    Obligation to Respond: Mandatory. Statutory authority for this information collection is contained in 47 U.S.C. 154(i), 301, 302, 303(e), 303(f) and 303(r).

    Total Annual Burden: 200 hours.

    Total Annual Cost: No cost.

    Privacy Act Impact Assessment: No impact(s).

    Nature and Extent of Confidentiality: There is no need for confidentiality.

    Needs and Uses: The Commission will submit this expiring information collection to the Office of Management and Budget (OMB) after this 60 day comment period in order to obtain the three year clearance. Section 15.240 requires each grantee of certification for Radio Frequency Identification (RFID) Equipment to register the location of the equipment/devices its markets with the Commission. The information that the grantee must supply to the Commission when registering the device(s) shall include the name, address and other pertinent contact information of users, the geographic coordinates of the operating location, and the FCC identification number(s) of the equipment. The improved RFID equipment could benefit commercial shippers and have significant homeland security benefits by enabling the entire contents of shipping containers to be easily and immediately identified, and by allowing a determination of whether tampering with their contents has occurred during shipping.

    Federal Communications Commission. Gloria J. Miles, Federal Register Liaison Officer, Office of the Secretary.
    [FR Doc. 2016-23916 Filed 10-3-16; 8:45 am] BILLING CODE 6712-01-P
    FEDERAL ELECTION COMMISSION Sunshine Act Meeting AGENCY:

    Federal Election Commission.

    DATE AND TIME:

    Thursday, September 29, 2016 at the conclusion of the open meeting.

    PLACE:

    999 E Street NW., Washington, DC.

    STATUS:

    This meeting was closed to the public.

    ITEMS DISCUSSED:

    Matters concerning participation in civil actions or proceeding, or arbitration. Internal personnel rules and internal rules and practices.

    PERSON TO CONTACT FOR INFORMATION:

    Judith Ingram, Press Officer, Telephone: (202) 694-1220.

    Shelley E. Garr, Deputy Secretary.
    [FR Doc. 2016-24040 Filed 9-30-16; 11:15 am] BILLING CODE 6715-01-P
    FEDERAL RESERVE SYSTEM Formations of, Acquisitions by, and Mergers of Bank Holding Companies

    The companies listed in this notice have applied to the Board for approval, pursuant to the Bank Holding Company Act of 1956 (12 U.S.C. 1841 et seq.) (BHC Act), Regulation Y (12 CFR part 225), and all other applicable statutes and regulations to become a bank holding company and/or to acquire the assets or the ownership of, control of, or the power to vote shares of a bank or bank holding company and all of the banks and nonbanking companies owned by the bank holding company, including the companies listed below.

    The applications listed below, as well as other related filings required by the Board, are available for immediate inspection at the Federal Reserve Bank indicated. The applications will also be available for inspection at the offices of the Board of Governors. Interested persons may express their views in writing on the standards enumerated in the BHC Act (12 U.S.C. 1842(c)). If the proposal also involves the acquisition of a nonbanking company, the review also includes whether the acquisition of the nonbanking company complies with the standards in section 4 of the BHC Act (12 U.S.C. 1843). Unless otherwise noted, nonbanking activities will be conducted throughout the United States.

    Unless otherwise noted, comments regarding each of these applications must be received at the Reserve Bank indicated or the offices of the Board of Governors not later than October 28, 2016.

    A. Federal Reserve Bank of New York (Ivan Hurwitz, Vice President) 33 Liberty Street, New York, New York 10045-0001. Comments can also be sent electronically to [email protected]:

    1. NSB Holdings, Inc., and NSB Mutual Holding Company, both of Newtown, Connecticut; to become bank holding companies by acquiring 100 percent of the voting shares of Newtown Savings Bank, Newtown, Connecticut.

    Board of Governors of the Federal Reserve System, September 29, 2016. Michele Taylor Fennell, Assistant Secretary of the Board.
    [FR Doc. 2016-23959 Filed 10-3-16; 8:45 am] BILLING CODE 6210-01-P
    DEPARTMENT OF DEFENSE GENERAL SERVICES ADMINISTRATION NATIONAL AERONAUTICS AND SPACE ADMINISTRATION [OMB Control No. 9000-0136]; [Docket 2016-0053; Sequence 28] Submission for OMB Review; Commercial Item Acquisitions AGENCY:

    Department of Defense (DOD), General Services Administration (GSA), and National Aeronautics and Space Administration (NASA).

    ACTION:

    Notice of request for comments regarding an extension to an existing OMB clearance.

    SUMMARY:

    Under the provisions of the Paperwork Reduction Act, the Regulatory Secretariat Division will be submitting to the Office of Management and Budget (OMB) a request to review and approve an extension of a previously approved information collection requirement concerning the clauses and provisions required for use in commercial item acquisitions. A notice was published in the Federal Register at 81 FR 43201 on July 1, 2016. No comments were received.

    DATES:

    Submit comments on or before November 3, 2016.

    ADDRESSES:

    Submit comments identified by Information Collection 9000-0136, Commercial Item Acquisitions, by any of the following methods:

    Regulations.gov: http://www.regulations.gov.

    Submit comments via the Federal eRulemaking portal by searching the OMB control number. Select the link “Submit a Comment” that corresponds with “Information Collection 9000-0136, Commercial Item Acquisitions”. Follow the instructions provided at the “Submit a Comment” screen. Please include your name, company name (if any), and “Information Collection 9000-0136, Commercial Item Acquisitions” on your attached document.

    Mail: General Services Administration, Regulatory Secretariat Division (MVCB), 1800 F Street NW., Washington, DC 20405. ATTN: Ms. Flowers/IC 9000-0136, Commercial Item Acquisitions.

    Instructions: Please submit comments only and cite Information Collection 9000-0136, Commercial Item Acquisitions, in all correspondence related to this collection. Comments received generally will be posted without change to http://www.regulations.gov, including any personal and/or business confidential information provided. To confirm receipt of your comment(s), please check www.regulations.gov, approximately two to three days after submission to verify posting (except allow 30 days for posting of comments submitted by mail).

    FOR FURTHER INFORMATION CONTACT:

    Mr. Michael O. Jackson, Procurement Analyst, Office of Governmentwide Acquisition Policy, GSA, at 202-208-4949, or email at [email protected]

    SUPPLEMENTARY INFORMATION:

    A. Purpose

    The Federal Acquisition Streamlining Act of 1994 reformed Federal acquisition statutes to encourage and facilitate the acquisition of commercial items and services by the Federal Government. Accordingly, DoD, NASA, and GSA amended the Federal Acquisition Regulation (FAR) to include streamlined/simplified procedures for the acquisition of commercial items.

    Pertinent to this information collection, FAR Provision 52.212-3, “Offeror Representations and Certifications—Commercial Items,” was implemented to combine the multitude of individual provisions used in Government solicitations into a single provision for use in commercial acquisitions. The provision is among the representations and certifications that are available for completion in the System for Award Management (SAM).

    B. Annual Reporting Burden

    Respondents: 397,000.

    Responses per Respondent: 1.46.

    Total Responses: 579,620.

    Hours per Response: .500.

    Total Burden Hours: 289,810.

    Frequency: On Occasion.

    Affected Public: Businesses or other for-profit and not-for-profit institutions.

    C. Public Comments

    Public comments are particularly invited on: Whether this collection of information is necessary for the proper performance of functions of the Federal Acquisition Regulations (FAR), and whether it will have practical utility; whether our estimate of the public burden of this collection of information is accurate, and based on valid assumptions and methodology; ways to enhance the quality, utility, and clarity of the information to be collected; and ways in which we can minimize the burden of the collection of information on those who are to respond, through the use of appropriate technological collection techniques or other forms of information technology.

    Obtaining Copies of Proposals: Requesters may obtain a copy of the information collection documents from the General Services Administration, Regulatory Secretariat Division (MVCB), 1800 F Street NW., Washington, DC 20405, telephone 202-501-4755.

    Please cite OMB Control No. 9000-0136 regarding Commercial Item Acquisitions in all correspondence.

    Dated: September 28, 2016. Lorin S. Curit, Director, Federal Acquisition Policy Division, Office of Governmentwide Acquisition Policy, Office of Acquisition Policy, Office of Governmentwide Policy.
    [FR Doc. 2016-23868 Filed 10-3-16; 8:45 am] BILLING CODE 6820-EP-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention [60Day-16-16BFQ; Docket No. CDC-2016-0096] Proposed Data Collection Submitted for Public Comment and Recommendations AGENCY:

    Centers for Disease Control and Prevention (CDC), Department of Health and Human Services (HHS).

    ACTION:

    Notice with comment period.

    SUMMARY:

    The Centers for Disease Control and Prevention (CDC), as part of its continuing efforts to reduce public burden and maximize the utility of government information, invites the general public and other Federal agencies to take this opportunity to comment on proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995. This notice invites comment on a proposed study project entitled “Survey of Sexually Transmitted Disease (STD) Provider Practices in the United States”. The primary goal of this study is to better understand policies and practices for STD care delivery among medical providers who typically see patients for STDs. Another goal is to assess awareness and use of CDC's STD treatment guidelines.

    DATES:

    Written comments must be received on or before December 5, 2016.

    ADDRESSES:

    You may submit comments, identified by Docket No. CDC-2016-0096 by any of the following methods:

    Federal eRulemaking Portal: Regulations.gov. Follow the instructions for submitting comments.

    Mail: Leroy A. Richardson, Information Collection Review Office, Centers for Disease Control and Prevention, 1600 Clifton Road NE., MS-D74, Atlanta, Georgia 30329.

    Instructions: All submissions received must include the agency name and Docket Number. All relevant comments received will be posted without change to Regulations.gov, including any personal information provided. For access to the docket to read background documents or comments received, go to Regulations.gov.

    Please note: All public comment should be submitted through the Federal eRulemaking portal (Regulations.gov) or by U.S. mail to the address listed above.

    FOR FURTHER INFORMATION CONTACT:

    To request more information on the proposed project or to obtain a copy of the information collection plan and instruments, contact the Information Collection Review Office, Centers for Disease Control and Prevention, 1600 Clifton Road NE., MS-D74, Atlanta, Georgia 30329; phone: 404-639-7570; Email: [email protected]

    SUPPLEMENTARY INFORMATION:

    Under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3520), Federal agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. In addition, the PRA also requires Federal agencies to provide a 60-day notice in the Federal Register concerning each proposed collection of information, including each new proposed collection, each proposed extension of existing collection of information, and each reinstatement of previously approved information collection before submitting the collection to OMB for approval. To comply with this requirement, we are publishing this notice of a proposed data collection as described below.

    Comments are invited on: (a) Whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility; (b) the accuracy of the agency's estimate of the burden of the proposed collection of information; (c) ways to enhance the quality, utility, and clarity of the information to be collected; (d) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or other forms of information technology; and (e) estimates of capital or start-up costs and costs of operation, maintenance, and purchase of services to provide information. Burden means the total time, effort, or financial resources expended by persons to generate, maintain, retain, disclose or provide information to or for a Federal agency. This includes the time needed to review instructions; to develop, acquire, install and utilize technology and systems for the purpose of collecting, validating and verifying information, processing and maintaining information, and disclosing and providing information; to train personnel and to be able to respond to a collection of information, to search data sources, to complete and review the collection of information; and to transmit or otherwise disclose the information.

    Proposed Project

    Survey of Sexually Transmitted Disease (STD) Provider Practices in the United States—NEW—National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention (NCHHSTP), Centers for Disease Control and Prevention (CDC).

    Background and Brief Description

    Each year, 19.7 million sexually transmitted diseases (STDs) occur in the U.S., half of which strike youth 15−24 years of age.—The public health burden of STDs is compounded by their economic impact. In 2010, an estimated $15.6 billion in direct medical costs were attributed to STDs. Undiagnosed and untreated STDs can lead to serious long-term health consequences, especially for adolescent girls and young adult women. For example, every year, about 24,000 young women become infertile as a result of undiagnosed and untreated STDs. The STD Provider Survey will collect much needed data from U.S. health care providers in specialties that typically see STD patients, including physician specialties such as obstetrics/gynecology, internal medicine, general or family practice, emergency medicine, or pediatrics. Knowledge of provider practices relative to guidelines and state-level laws and policies will provide information useful to stakeholders at all levels regarding the delivery of STD preventive services and treatment by health care providers in the U.S. As providers are one of the few professionals who have face-to-face contact with persons infected with STDs, they are also a potential intervention point for attempts to reduce re-infection and halt the further transmission of STDs. There is no national survey that collects detailed information on STD practices of physicians who typically see STD patients.

    The purpose of this survey is to conduct a nationally representative survey of physicians who typically see STD patients (e.g., primary care—including internal medicine, general or family practice, obstetrics/gynecology, emergency medicine, and pediatrics) that would allow for national estimates and comparisons among specialties. Additionally, the survey will provide national estimates for comparisons between providers in the public and private sectors. Information collected will also be used to determine STD prevention activities needed by type of providers (by specialty or public/private) based on findings related to screening and treatment practices for STDs including EPT.

    The survey contains sections on the physician's specialty areas, primary practice setting, primacy practice policies, patient demographics, STD testing and diagnosis, STD care and treatment, and respondent demographics.

    In an effort to better understand policies and practices for STD care delivery among medical providers who typically see patients for STDs, the surveys will be sent to a random sample of 5,000 U.S. physicians across several specialties using the American Medical Association Master file. Using a multimode design (mail and web), multiple reminders will be sent to non-responders in order to reach the target of 3,000 completed surveys.

    There is no cost to respondents.

    Estimated Annualized Burden Hours Type of respondents Form name Number of
  • respondents
  • Number of
  • responses per
  • respondent
  • Average
  • burden per
  • response
  • (in hours)
  • Total burden
  • (in hours)
  • Physicians responding via Mail STD Provider Survey 2,250 1 20/60 750 Physicians responding via Web STD Provider Survey 750 1 32/60 400 Total 1,150
    Leroy A. Richardson, Chief, Information Collection Review Office, Office of Scientific Integrity, Office of the Associate Director for Science, Office of the Director, Centers for Disease Control and Prevention.
    [FR Doc. 2016-23925 Filed 10-3-16; 8:45 am] BILLING CODE 4163-18-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare & Medicaid Services Privacy Act of 1974; CMS Computer Match No. 2016-15; HHS Computer Match No. 1609 AGENCY:

    Department of Health and Human Services (HHS), Centers for Medicare & Medicaid Services (CMS).

    ACTION:

    Notice of Computer Matching Program.

    SUMMARY:

    In accordance with the requirements of the Privacy Act of 1974, as amended, this notice announces the establishment of a Computer Matching Program that CMS plans to conduct with the Peace Corps (PC).

    DATES:

    Comments are invited on all portions of this notice. Public comments are due within 30 days after publication. The matching program will become effective no sooner than 40 days after the report of the matching program is sent to the Office of Management and Budget (OMB) and Congress, or 30 days after publication in the Federal Register, whichever is later.

    ADDRESSES:

    The public should send comments to: CMS Privacy Act Officer, Division of Security, Privacy Policy & Governance, Information Security & Privacy Group, Office of Enterprise Information, CMS, Room N l-24-08, 7500 Security Boulevard, Baltimore, Maryland 21244-1850. Comments received will be available for review at this location, by appointment, during regular business hours, Monday through Friday from 9:00 a.m.-3:00 p.m., Eastern Time zone.

    FOR FURTHER INFORMATION CONTACT:

    Lindsey Murtagh, Center for Consumer Information and Insurance Oversight, Centers for Medicare & Medicaid Services, Phone: (301) 492-4106, Email: [email protected]

    SUPPLEMENTARY INFORMATION:

    The Computer Matching and Privacy Protection Act of 1988 (Public Law (Pub. L.) 100-503), amended the Privacy Act (5 U.S.C. 552a) by describing the manner in which computer matching involving Federal agencies could be performed and adding certain protections for individuals applying for and receiving Federal benefits. Section 7201 of the Omnibus Budget Reconciliation Act of 1990 (Pub. L. 101-508) further amended the Privacy Act regarding protections for such individuals. The Privacy Act, as amended, regulates the use of computer matching by Federal agencies when records in a system of records are matched with other Federal, state, or local government records. It requires Federal agencies involved in a CMP to:

    1. Negotiate written agreements with the other agencies participating in the matching programs;

    2. Obtain the Data Integrity Board approval of the match agreements;

    3. Furnish detailed reports about matching programs to Congress and OMB;

    4. Notify applicants and beneficiaries that the records are subject to matching; and,

    5. Verify match findings before reducing, suspending, terminating, or denying an individual's benefits or payments.

    This matching program meets the requirements of the Privacy Act of 1974, as amended.

    Walter Stone, CMS Privacy Act Officer, Centers for Medicare & Medicaid Services. CMS Computer Match No. 2016-15 HHS Computer Match No.1609 NAME:

    Computer Matching Agreement between the Department of Health and Human Services, Centers for Medicare & Medicaid Services and the Peace Corps for the “Verification of Eligibility for Minimum Essential Coverage Under the Patient Protection and Affordable Care Act Through a Peace Corps Health Benefits Plan.”

    SECURITY CLASSIFICATION:

    Unclassified

    PARTICIPATING AGENCIES:

    Department of Health and Human Services (HHS), Centers for Medicare & Medicaid Services (CMS), and the Peace Corps (PC).

    AUTHORITY FOR CONDUCTING MATCHING PROGRAM:

    Sections 1411 and 1413 of the Patient Protection and Affordable Care Act of 2010 (Pub. L. 111-148), as amended by the Health Care and Education Reconciliation Act of 2010 (Pub. L. 111-152) (collectively, the ACA) require the Secretary of HHS to establish a program for applying for and determining eligibility for advance payments of the premium tax credit and cost-sharing reductions and authorize use of secure, electronic interfaces and an on-line system for the verification of eligibility.

    The Computer Matching and Privacy Protection Act of 1988 (CMPPA) (Pub. L. 100-503), amended the Privacy Act (5 U.S.C. 552a) and requires the parties participating in a matching program to execute a written agreement specifying the terms and conditions under which the matching will be conducted. CMS has determined that status verification checks to be conducted through the CMS Data Services Hub (Hub) by agencies administering insurance affordability programs using data provided in bulk by PC through a security transfer data protocol to CMS constitute a “computer matching program” as defined in the CMPPA.

    PURPOSE(S) OF THE MATCHING PROGRAM:

    The purpose of the Computer Matching Agreement is to establish the terms, conditions, safeguards, and procedures under which the Peace Corps will provide records, information, or data to CMS for verifying eligibility for Minimum Essential Coverage through a Peace Corps Health Benefits Plan. The data will be used by CMS in its capacity as a Federally-facilitated Exchange, and agencies administering insurance affordability programs that will receive the results of verifications using PC data obtained through the CMS Data Services Hub.

    Data will be matched for the purpose of verifying an Applicant or Enrollee's eligibility for PC Health Benefit Plans that constitute minimum essential coverage as defined in § 5000A(f) of the Internal Revenue Code of 1986, 26 U.S.C. 5000A, as amended by § 1501 of the ACA.

    DESCRIPTION OF RECORDS TO BE USED IN THE MATCHING PROGRAM:

    The Peace Corps maintains the following SORN to support this data matching program: “Peace Corps Manual Section 897, Attachment B, PC-17 Volunteer Applicant and Service Records System.” Routine Use (i) is used “to verify active or former Volunteer service”—supports disclosure to CMS.

    CMS maintains the following SORN to support this data to support this data matching program: “Health Insurance Exchanges Program (HIX)”, CMS System No. 09-70-0560, originally published at 78 Fed. Reg. 8538 (Feb. 6, 2013), and last amended at 78 Federal Register, 63211 (October 23, 2013).

    INCLUSIVE DATES OF THE MATCH:

    The CMP will become effective no sooner than 40 days after the report of the matching program is sent to 0MB, 30 days after a copy of the matching agreement is transmitted to Congress, or 30 days after publication in the Federal Register, whichever is later. The matching program will continue for 18 months from the effective date and may be extended for an additional 12 months thereafter, if certain conditions are met.

    [FR Doc. 2016-23866 Filed 10-3-16; 8:45 am] BILLING CODE 4120-03-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Administration for Children and Families [CFDA NUMBER: 93.658] Announcement of a Single-Source Supplement Grant to the National Child Welfare Capacity Building Center for Tribes AGENCY:

    Children's Bureau, ACYF, ACF, HHS.

    ACTION:

    Notice.

    SUMMARY:

    The Administration for Children and Families (ACF), Administration for Children Youth and Families (ACYF), Children's Bureau announces the award of a single-source supplement grant in the amount of $547,000 to the National Child Welfare Capacity Building Center for Tribes (CBCT), operated by the University of Denver (Colorado Seminary). The primary goal of this grant is to provide capacity-building services to title IV-E and IV-B American Indian and Alaska Native Nations (AI/AN), and to promote intergovernmental collaboration between tribes and state child welfare agencies in system improvement work.

    DATES:

    Supplemental funding will support activities and costs from September 30, 2016, through September 29, 2017.

    FOR FURTHER INFORMATION CONTACT:

    Dr. Roshanda Shoulders, Children's Bureau, 330 C Street SW., Washington, DC 20024. Telephone: 202-401-5323; email: [email protected]

    SUPPLEMENTARY INFORMATION:

    Supplemental funds would be used to enhance the development and delivery of high-quality products and services designed to build the capacities of child welfare systems to improve outcomes for AI/AN children, youth, and families and their communities. These enhanced services will build on CBCT's existing engagement and partnerships with state and tribal child welfare agencies to further address the needs of, and reduce disparities for, native children and families (e.g., rates of removal and placement in out-of-home care, access to effective and culturally appropriate services, well-being outcomes), and improve overall child welfare services delivery and outcomes for AI/AN children youth and families.

    The supplemental funding will afford CBCT the opportunity to provide expanded universal and tailored technical assistance to tribes across the nation and allow for expanded and enhanced collaboration and coordination with the other capacity building providers.

    The programmatic components targeted under this supplement will be for CBCT expansion activities to better meet the national need for universal and tailored services to tribal child welfare agencies. Over 180 tribes are eligible to receive capacity-building services through CBCT based on their management of title IV-B and tribal title IV-E funded programs. There has been a concerted outreach effort to encourage a maximum number of tribes to access services through CBCT.

    Statutory Authority:

    Section 426(a)(1)(A) of the Social Security Act (42 U.S.C. 626(a)(1)(A)).

    Mary M. Wayland, Senior Grants Policy Specialist, Division of Grants Policy, Office of Administration.
    [FR Doc. 2016-23909 Filed 10-3-16; 8:45 am] BILLING CODE 4184-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Administration for Children and Families Proposed Information Collection Activity; Comment Request

    Proposed Projects: Updating the Immigration Judge with information about the unaccompanied minor's case and reunification with a sponsor.

    Title: Unaccompanied Children Case Summary Form.

    OMB No.: New.

    Description: Following the passage of the 2002 Homeland Security Act (Pub. L. 107-296), the Administration for Children and Families (ACF), Office of Refugee Resettlement (ORR), is charged with the care and placement of unaccompanied children in Federal custody. Unaccompanied children attend immigration court hearings while in ORR care if the length of stay is more than sixty days. The form in question was created with input from immigration judges at the Executive Office for Immigration Review (EOIR).

    The proposed information collection requests information to be utilized by EOIR for determining the best course of action to take in the UC's case in immigration court. The proposed instrument is the Unaccompanied Children Case Summary Form.

    Respondents: Case Managers who are employees of social service agencies receiving grants from ORR to vet potential sponsors and to help advance the UC's case by providing updates to the Immigration Judge hearing the UC's case requesting legal relief from deportation.

    Annual Burden Estimates Instrument Number of
  • respondents
  • Number of
  • responses per respondent
  • Average
  • burden hours
  • per response
  • Total burden hours
    UAC Case Summary 100 10 .10 100

    Estimated Total Annual Burden Hours: In compliance with the requirements of Section 506(c)(2)(A) of the Paperwork Reduction Act of 1995, the Administration for Children and Families is soliciting public comment on the specific aspects of the information collection described above. Copies of the proposed collection of information can be obtained and comments may be forwarded by writing to the Administration for Children and Families, Office of Planning, Research and Evaluation, 370 L'Enfant Promenade SW., Washington, DC 20447, Attn: ACF Reports Clearance Officer. Email address: [email protected] All requests should be identified by the title of the information collection.

    The Department specifically requests comments on: (a) Whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility; (b) the accuracy of the agency's estimate of the burden of the proposed collection of information; (c) the quality, utility, and clarity of the information to be collected; and (d) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or other forms of information technology. Consideration will be given to comments and suggestions submitted within 60 days of this publication.

    Robert Sargis, Reports Clearance Officer.
    [FR Doc. 2016-23951 Filed 10-3-16; 8:45 am] BILLING CODE 4184-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Administration for Children and Families Submission for OMB Review; Comment Request

    Title: Interstate Administrative Subpoena and Notice of Interstate Lien.

    OMB No.: 0970-0152.

    Description: Section 452(a)(11) of the Social Security Act requires the Secretary of the Department of Health and Human Services to promulgate a form for administrative subpoenas and imposition of liens used by State child support enforcement (Title IV-D) agencies. The Interstate Administrative Subpoena is used to collect information for the establishment, modification and enforcement of child support orders in interstate cases. Section 454(9)(E) of the Social Security Act requires each State to cooperate with any other State in using the federal form for issuance of administrative subpoenas and imposition of liens in interstate child support cases. Tribal IV-D agencies are not required to use this form but may choose to do so. OMB approval of these forms is expiring in December 2016 and the Administration for Children and Families is requesting an extension of this form.

    Respondents: State, local or Tribal agencies administering a child support enforcement program under title IV-D of the Social Security Act.

    Annual Burden Estimates Instrument Number of
  • respondents
  • Number of
  • responses per
  • respondent
  • Average
  • burden hours
  • per response
  • Total burden
  • hours
  • Administrative Subpoena 31,344 1 0.50 15,672 Notice of Lien 1,916,891 1 0.25 479,223

    Estimated Total Annual Burden Hours: 494,895.

    Additional Information

    Copies of the proposed collection may be obtained by writing to the Administration for Children and Families, Office of Planning, Research and Evaluation, 330 C Street SW., Washington, DC 20201. Attention Reports Clearance Officer. All requests should be identified by the title of the information collection. Email address: [email protected]

    OMB Comment

    OMB is required to make a decision concerning the collection of information between 30 and 60 days after publication of this document in the Federal Register. Therefore, a comment is best assured of having its full effect if OMB receives it within 30 days of publication. Written comments and recommendations for the proposed information collection should be sent directly to the following: Office of Management and Budget, Paperwork Reduction Project, Email: [email protected] Attn: Desk Officer for the Administration for Children and Families.

    Robert Sargis, Reports Clearance Officer.
    [FR Doc. 2016-23950 Filed 10-3-16; 8:45 am] BILLING CODE 4184-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Administration for Children and Families Proposed Information Collection Activity; Comment Request Proposed Projects

    Title: Income Withholding Order/Notice for Support (IWO).

    OMB No.: 0970-0154.

    Description: The Income Withholding Order/Notice for Support (IWO) is the standard form that must be used to order and notify employers and income providers to withhold child support payments from an obligor's income. It also indicates where employers and other income providers must remit the payments and other information needed to withhold correctly.

    Child support agencies, courts, private attorneys, custodial parties, and others must use the IWO form to initiate an income withholding order for support and give notice of income withholding. State child support agencies are required to have automated data processing systems containing current order and case information. State child support agencies providing services to custodial and/or noncustodial parties enter the terms of a child support order established by a tribunal into the state's automated system, which automatically populates the order information into the IWO form.

    Employers and income providers also use the form to respond to the order/notice with termination or income status information. Employers and other income providers may choose to receive the IWO form from child support agencies on paper or electronically, and may respond on paper or electronically to notify the sender of termination of employment or change in the income status.

    The information collection activities pertaining to the IWO form are authorized by 42 U.S.C. 666(a)(1), (a)(8) and 666(b)(6), which require the use of the Income Withholding for Support (IWO) form to order income withholding for all child support orders.

    Respondents: Courts, private attorneys, custodial parties or their representatives, employers, and other parties that provide income to noncustodial parents.

    Annual Burden Estimates Instrument Number of
  • respondents
  • Number of
  • responses per
  • respondent
  • Average
  • burden hours
  • per response
  • Total burden
  • hours
  • Income withholding order/notice (Courts, private attorneys, custodial parties or their representatives) 3,699,790 1.00 5 minutes 308,316 Income withholding orders/termination of employment/income status (Employers and other income providers) 1,207,484 9.694 2 minutes 390,178 Electronic income withholding orders/termination of employment/income status (Employers and other income providers) 9,596 136.38 3 seconds 1,090 Estimated Total Annual Burden Hours 699,585

    In compliance with the requirements of the Paperwork Reduction Act of 1995 (Pub. L. 104-13, 44 U.S.C. Chap 35), the Administration for Children and Families is soliciting public comment on the specific aspects of the information collection described above. Copies of the proposed collection of information can be obtained and comments may be forwarded by writing to the Administration for Children and Families, Office of Planning, Research and Evaluation, 330 C Street SW., Washington DC 20201. Attn: ACF Reports Clearance Officer. Email address: [email protected] All requests should be identified by the title of the information collection.

    The Department specifically requests comments on: (a) Whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility; (b) the accuracy of the agency's estimate of the burden of the proposed collection of information; (c) the quality, utility, and clarity of the information to be collected; and (d) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or other forms of information technology. Consideration will be given to comments and suggestions submitted within 60 days of this publication.

    Robert Sargis, Reports Clearance Officer.
    [FR Doc. 2016-23865 Filed 10-3-16; 8:45 am] BILLING CODE 4184-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2016-N-2655] Center for Devices and Radiological Health Veteran Amputee Devices; Public Workshop; Request for Comments AGENCY:

    Food and Drug Administration, HHS.

    ACTION:

    Notice of public workshop; request for comments.

    SUMMARY:

    The Food and Drug Administration (FDA) is announcing the following public workshop entitled “Center for Devices and Radiological Health Veteran Amputee Devices.” The purpose of this workshop is to engage all stakeholders involved in the research, development, and marketing of prosthetic limb medical devices used by veteran amputees. A specific goal is to engage veteran amputees who use prosthetic limb medical devices and hear their views on these devices so that these perspectives may be considered in the total product life cycle of prosthetic limb devices.

    DATES:

    The public workshop will be held on October 31, 2016, from 9 a.m. to 4 p.m. Submit either electronic or written comments on the public workshop by November 30, 2016.

    ADDRESSES:

    The public workshop will be held at FDA's White Oak Campus, 10903 New Hampshire Ave., Bldg. 31 Conference Center, the Great Room (Rm. 1503), Silver Spring, MD 20993. Entrance for the public meeting participants (non-FDA employees) is through Building 1 where routine security check procedures will be performed. For parking and security information, please refer to http://www.fda.gov/AboutFDA/WorkingatFDA/BuildingsandFacilities/WhiteOakCampusInformation/ucm241740.htm.

    You may submit comments as follows:

    Electronic Submissions

    Submit electronic comments in the following way:

    Federal eRulemaking Portal: http://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to http://www.regulations.gov will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else's Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on http://www.regulations.gov.

    • If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see “Written/Paper Submissions” and “Instructions”).

    Written/Paper Submissions

    Submit written/paper submissions as follows:

    Mail/Hand delivery/Courier (for written/paper submissions): Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

    • For written/paper comments submitted to the Division of Dockets Management, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in “Instructions.”

    Instructions: All submissions received must include the Docket No. FDA-2016-N-2655 for “Center for Devices and Radiological Health Veteran Amputee Devices.” Received comments will be placed in the docket and, except for those submitted as “Confidential Submissions,” publicly viewable at http://www.regulations.gov or at the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.

    • Confidential Submissions—To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states “THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.” The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on http://www.regulations.gov. Submit both copies to the Division of Dockets Management. If you do not wish your name and contact information to be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify this information as “confidential.” Any information marked as “confidential” will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law. For more information about FDA's posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: http://www.fda.gov/regulatoryinformation/dockets/default.htm.

    Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to http://www.regulations.gov and insert the docket number, found in brackets in the heading of this document, into the “Search” box and follow the prompts and/or go to the Division of Dockets Management, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

    FOR FURTHER INFORMATION CONTACT:

    Fabienne Santel, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 3502, Silver Spring, MD 20993, 301-796-9644, email: [email protected]

    SUPPLEMENTARY INFORMATION:

    I. Background

    The Center for Devices and Radiological Health (CDRH) is committed to including views of patients on the total product life cycle of medical devices. To better understand their needs, CDRH plans to engage patients throughout our regulatory process. CDRH is interested in patients contributing their views, data, and resources to improve the total product life cycle for medical devices, reduce adverse events, and improve communication about the risks and benefits that matter most to them.

    Together with other centers and offices across FDA, we are testing and developing ways to engage patients and capture their views through public workshops. The CDRH Veteran Amputee Devices is one such workshop intended to engage veteran amputees, such as those patients from the Walter Reed National Military Medical Center, Warrior Clinic, who use prosthetic limb medical devices.

    II. Topics for Discussion at the CDRH Veteran Amputee Devices Public Workshop

    Topics to be discussed at the public workshop include, but are not limited to the following:

    • Introduce the CDRH Total Product life Cycle (TPLC) for prosthetic limb devices.

    • A focus group to obtain information on priorities for upper-limb prosthetics from the perspective of upper-limb amputees.

    • Presentations from prosthetic limb device manufacturer.

    • Question and answer session where patients, their caregivers and other interested parties have an opportunity to present their views and ask questions about the total product life cycle of medical devices.

    Registration: Registration is free and available on a first-come, first-served basis. Persons interested in attending the CDRH Veteran Amputee Devices public workshop must register online by October 24, 2016. Early registration is recommended because facilities are limited and, therefore, FDA may limit the number of participants from each organization. If time and space permit, onsite registration on the day of the public workshop will be begin at 8 a.m.

    If you need special accommodations due to a disability, please contact Susan Monahan, Center for Devices and Radiological Health, Office of Communication, Education (OCE), 301-796-5661 email: [email protected] no later than October 17, 2016.

    To register for the public workshop, please visit FDA's Medical Devices News & Events—Workshops & Conferences calendar at http://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/default.htm. (Select this meeting/public workshop from the posted events list.) Please provide complete contact information for each attendee, including name, title, affiliation, address, email, and telephone number. Those without Internet access should contact Fabienne Santel to register (see FOR FURTHER INFORMATION CONTACT). Registrants will receive confirmation after they have been accepted. You will be notified if you are on a waiting list.

    Streaming Webcast of the Public Workshop: This public workshop will also be Webcast. The Webcast link will be available on the registration Web page after October 21, 2016. Organizations are requested to view using one connection per location. If you have never attended a Connect Pro event before, test your connection at https://collaboration.fda.gov/common/help/en/support/meeting_test.htm. To get a quick overview of the Connect Pro program, visit http://www.adobe.com/go/connectpro_overview. FDA has verified the Web site addresses in this document, as of the date this document publishes in the Federal Register, but Web sites are subject to change over time.

    Requests for Oral Presentations: This public workshop includes a public comment session and topic-focused sessions. During online registration, you may indicate if you wish to present during a public comment session or participate in a specific session, and which topics you wish to address. FDA has included general topics in this document. FDA will do its best to accommodate requests to make public comments or give presentations during the focused sessions. Individuals and organizations with common interests are urged to consolidate or coordinate their presentations, and request time for a joint presentation, or submit requests for designated representatives to participate in the focused sessions. FDA will determine the amount of time allotted to each presenter and the approximate time each oral presentation is to begin, and will select and notify participants by October 17, 2016. All requests to make oral presentations must be received by October 10, 2016. If selected for presentation, any presentation materials must be emailed to Fabienne Santel (see FOR FURTHER INFORMATION CONTACT) no later than October 28, 2016. If you are a manufacturer and wish to have a display table, please submit this request by October 17, 2016. Space is limited; therefore, FDA will select and notify manufacturers by October 24, 2016. No commercial or promotional material will be permitted to be presented or distributed at the public workshop.

    FDA is holding this public workshop to obtain views from patients on prosthetic limb devices so that these perspectives may be considered in the total product life cycle of prosthetic limb medical devices. In order to permit the widest possible opportunity to obtain public comment, FDA is soliciting either electronic or written comments on all aspects of the public workshop topics. The deadline for submitting comments related to this patient workshop is November 30, 2016.

    Transcripts: Please be advised that as soon as a transcript is available, it will be accessible at http://www.regulations.gov. It may be viewed at the Division of Dockets Management (see ADDRESSES). A transcript will also be available in either hardcopy or on CD-ROM, after submission of a Freedom of Information request. The Freedom of Information office address is available on the Agency's Web site at http://www.fda.gov. A link to the transcripts will also be available approximately 45 days after the public workshop on the Internet at http://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/default.htm. (Select this public workshop from the posted events list).

    Dated: September 26, 2016. Leslie Kux, Associate Commissioner for Policy.
    [FR Doc. 2016-23924 Filed 10-3-16; 8:45 am] BILLING CODE 4164-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2016-N-2976] Agency Information Collection Activities; Proposed Collection; Comment Request; Information From United States Firms and Processors That Export to the European Union AGENCY:

    Food and Drug Administration, HHS.

    ACTION:

    Notice.

    SUMMARY:

    The Food and Drug Administration (FDA or we) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on reporting requirements in implementing the lists of United States (U.S.) firms/processors exporting shell eggs, game meat and game meat products, gelatin, and collagen to the European Union (the EU).

    DATES:

    Submit either electronic or written comments on the collection of information by December 5, 2016.

    ADDRESSES:

    You may submit comments as follows:

    Electronic Submissions

    Submit electronic comments in the following way:

    Federal eRulemaking Portal: http://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to http://www.regulations.gov will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else's Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on http://www.regulations.gov.

    • If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see “Written/Paper Submissions” and “Instructions”).

    Written/Paper Submissions

    Submit written/paper submissions as follows:

    Mail/Hand delivery/Courier (for written/paper submissions): Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

    • For written/paper comments submitted to the Division of Dockets Management, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in “Instructions.”

    Instructions: All submissions received must include the Docket No. FDA-2016-N-2976 for “Agency Information Collection Activities; Proposed Collection; Comment Request; Information From United States Firms and Processors That Export to the European Union.” Received comments will be placed in the docket and, except for those submitted as “Confidential Submissions,” publicly viewable at http://www.regulations.gov or at the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.

    • Confidential Submissions—To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states “THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.” The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on http://www.regulations.gov. Submit both copies to the Division of Dockets Management. If you do not wish your name and contact information to be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify this information as “confidential.” Any information marked as “confidential” will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law. For more information about FDA's posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: http://www.fda.gov/regulatoryinformation/dockets/default.htm.

    Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to http://www.regulations.gov and insert the docket number, found in brackets in the heading of this document, into the “Search” box and follow the prompts and/or go to the Division of Dockets Management, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

    FOR FURTHER INFORMATION CONTACT:

    FDA PRA Staff, Office of Operations, Food and Drug Administration, Three White Flint North, 10A63, 11601 Landsdown St., North Bethesda, MD 20852, [email protected]

    SUPPLEMENTARY INFORMATION:

    Under the PRA (44 U.S.C. 3501-3520), Federal Agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. “Collection of information” is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes Agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) requires Federal Agencies to provide a 60-day notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, before submitting the collection to OMB for approval. To comply with this requirement, FDA is publishing notice of the proposed collection of information set forth in this document.

    With respect to the following collection of information, FDA invites comments on these topics: (1) Whether the proposed collection of information is necessary for the proper performance of FDA's functions, including whether the information will have practical utility; (2) the accuracy of FDA's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques, when appropriate, and other forms of information technology.

    Information From U.S. Firms and Processors That Export to the EU (OMB Control Number 0910-0320)—Extension

    The EU is a group of 28 European countries that have agreed to harmonize their commodity requirements to facilitate commerce among member States. For certain food products, including those listed in this document, EU legislation requires assurances from the responsible authority of the country of origin that the processor of the food is in compliance with applicable regulatory requirements. Regulation (EC) No 854/2004 of the European Parliament and of the European Council states that products of animal origin may only be imported from establishments that appear on a list of establishments for which the competent authority of the exporting country has guaranteed compliance with applicable regulatory requirements and that shipments of these products must be accompanied by documents that certify the products' compliance with applicable regulatory standards. Section 801(e) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 381(e)) authorizes FDA to provide the certification described in this document. As stated in the notice published in the Federal Register of April 4, 1996 (61 FR 15077), we established a list of U.S. firms and processors eligible to export shell eggs, dairy products, and game meat and game meat products to the EU. In response to changing EU requirements, we revised this information collection and lists of eligible exporters in order to facilitate U.S. exports of gelatin and collagen to the EU. In 2001, we revised this collection to include firms and processors intending to export gelatin products to the EU (66 FR 12802, February 28, 2001) and in 2010, we revised the collection again to include firms and processors intending to export collagen products to the EU (75 FR 51077, August 18, 2010).

    We request the following information from each firm or processor seeking to be included on the lists of eligible exporters for shell eggs, and game meat and game meat products (dairy products will be covered under OMB control number 0910-0509):

    • Business name and address;

    • Name and telephone number of person designated as business contact;

    • Lists of products presently being shipped to the EU and those intended to be shipped in the next 6 months;

    • Name and address of manufacturing plants for each product; and

    • Names and affiliations of any Federal, State, or local governmental Agencies that inspect the plant, government-assigned plant identifier such as plant number, and last date of inspection.

    We request the following information from each firm or processor seeking to be included on the list of eligible exporters for gelatin and collagen products:

    • Food Facility Registration Number and Pin Number (if applicable);

    • Business name and address;

    • Name, telephone number, facsimile number, and email address of main business contact person;

    • List of products presently shipped to the EU and those intended to be shipped within the next 2 years;

    • Name and address of the manufacturing and processing plant for each product (manufacturer type for primary producer);

    • Names and affiliations of any Federal, State, and local governmental Agencies that inspect the plant, government assigned plant identifier, such as plant number and last date of inspection; and

    • A copy of the most recent (within 1 year of the date of application) inspection report issued by a State, local or Federal public health regulatory Agency and a copy of a recent laboratory analysis as required by the EU of the finished product including: Total aerobic bacteria, coliforms (30 degrees C), coliforms (44.5 degrees C), anaerobic sulphite-reducing bacteria (no gas production), Clostridium perfringens, Staphylococcus aureus, Salmonella, arsenic, lead, cadmium, mercury, chromium, copper, zinc, moisture (105 degrees C), ash (550 degrees C), sulfur dioxide, and hydrogen peroxide.

    We use the information to maintain lists of firms and processors that have demonstrated current compliance with U.S. requirements. We make the lists available on our Web site. We include on the lists only firms and processors that are not the subject of an unresolved regulatory enforcement action or unresolved warning letter. If a listed firm or processor subsequently becomes the subject of a regulatory enforcement action or an unresolved warning letter, we will view such a circumstance as evidence that the firm or processor is no longer in compliance with applicable U.S. laws and regulations. Should this occur, we will take steps to remove that firm or processor from the list and send a revised list to the EU authorities, usually within 48 to 72 hours after the relevant regulatory enforcement action. If a firm or processor has been delisted as a result of a regulatory enforcement action or unresolved warning letter, the firm or processor will have to reapply for inclusion on the list once the regulatory action has been resolved.

    We update the lists of firms and processors eligible to export products of animal origin to the EU quarterly. Firms and processors placed on lists of eligible exporters are subject to audit by FDA and EU officials. Complete requests for inclusion must be submitted to us every 12 months to remain on these lists. Inclusion on the lists is voluntary. However, products of animal origin from firms or processors not on lists of eligible exporters for these products are not eligible for export certificates for these products, and these products may be detained at EU ports of entry.

    Description of Respondents: The respondents to this collection of information include U.S. producers of shell eggs, game meat and game meat products, gelatin, and collagen.

    FDA estimates the burden of this collection of information as follows:

    Table 1—Estimated Annual Reporting Burden 1 Products Number of
  • respondents
  • Number of
  • responses per
  • respondent
  • Total annual responses Average burden
  • per response
  • Total hours
    Shell Eggs 10 1 10 0.25 (15 minutes) 3 Game Meat and Game Meat Products 5 1 5 0.25 (15 minutes) 1 Gelatin 7 1 7 0.25 (15 minutes) 2 Collagen 18 1 18 0.25 (15 minutes) 5 Total 11 1 There are no capital costs or operating and maintenance costs associated with this collection of information.

    We base our estimates of the number of respondents and total annual responses on the submissions that we have received in the past 3 years for each product type. To calculate the estimate for the hours per response values, we assumed that the information requested is readily available to the submitter. We expect that the submitter will need to gather information from appropriate persons in the submitter's company and to prepare this information for submission. We believe that this effort should take no longer than 15 minutes (0.25 hour) per response. We estimate that we will receive 1 submission from 10 shell egg producers annually, for a total of 10 annual responses. Each submission is estimated to take 0.25 hour per response for a total of 2.5 hours, rounded to 3 hours. This collection has previously covered information collected to maintain lists of eligible exporters of dairy products; dairy products will be covered under OMB control number 0910-0509, so the estimated burden has been removed from this collection. We estimate that we will receive one submission from five game meat and game meat product producers annually, for a total of five annual responses. Each submission is estimated to take 0.25 hour per response for a total of 1.25 hours, rounded to 1 hour. We estimate that we will receive one submission from seven gelatin producers annually, for a total of seven annual responses. Each submission is estimated to take 0.25 hour per response for a total of 1.75 hours, rounded to 2 hours. We estimate that we will receive one submission from 18 collagen producers annually, for a total of 18 annual responses. Each submission is estimated to take 0.25 hour per response for a total of 4.5 hours, rounded to 5 hours. The estimated burden for collagen producers includes animal casings, which have been listed separately in previous notices. Therefore, the proposed annual burden for this information collection is 11 hours.

    Dated: September 28, 2016. Leslie Kux, Associate Commissioner for Policy.
    [FR Doc. 2016-23930 Filed 10-3-16; 8:45 am] BILLING CODE 4164-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket Nos. FDA-2013-N-0115; FDA-2013-N-0717] Agency Information Collection Activities; Announcement of Office of Management and Budget Approvals AGENCY:

    Food and Drug Administration, HHS.

    ACTION:

    Notice.

    SUMMARY:

    The Food and Drug Administration (FDA) is publishing a list of information collections that have been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.

    FOR FURTHER INFORMATION CONTACT:

    FDA PRA Staff, Office of Operations, Food and Drug Administration, Three White Flint North, 11601 Landsdown St., North Bethesda, MD 20852, [email protected]

    SUPPLEMENTARY INFORMATION:

    The following is a list of FDA information collections recently approved by OMB under section 3507 of the Paperwork Reduction Act of 1995 (44 U.S.C. 3507). The OMB control number and expiration date of OMB approval for each information collection are shown in table 1. Copies of the supporting statements for the information collections are available on the Internet at http://www.reginfo.gov/public/do/PRAMain. An Agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number.

    Table 1—List of Information Collections Approved By OMB Title of collection OMB control
  • No.
  • Date approval expires
    Manufactured Food Regulatory Program Standards 0910-0601 9/30/2019 Evaluation of the Food and Drug Administration's General Market Youth Tobacco Prevention Campaign 0910-0753 9/30/2019
    Dated: September 27, 2016. Leslie Kux, Associate Commissioner for Policy.
    [FR Doc. 2016-23898 Filed 10-3-16; 8:45 am] BILLING CODE 4164-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2016-N-0002] Hospira, Inc. et al.; Withdrawal of Approval of 44 New Drug Applications and 158 Abbreviated New Drug Applications AGENCY:

    Food and Drug Administration, HHS.

    ACTION:

    Notice.

    SUMMARY:

    The Food and Drug Administration (FDA) is withdrawing approval of 44 new drug applications (NDAs) and 158 abbreviated new drug applications (ANDAs) from multiple applicants. The holders of the applications notified the Agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn.

    DATES:

    Effective Date: November 3, 2016.

    FOR FURTHER INFORMATION CONTACT:

    Florine P. Purdie, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6248, Silver Spring, MD 20993-0002, 301-796-3601.

    SUPPLEMENTARY INFORMATION:

    The holders of the applications listed in table 1 in this document have informed FDA that these drug products are no longer marketed and have requested that FDA withdraw approval of the applications under the process in § 314.150(c) (21 CFR 314.150(c)). The applicants have also, by their requests, waived their opportunity for a hearing. Withdrawal of approval of an application or abbreviated application under § 314.150(c) is without prejudice to refiling.

    Table 1 Application No. Drug Applicant NDA 005264 Heparin Sodium Injection Hospira, Inc., 275 North Field Dr., Bldg. H2-2, Lake Forest, IL 60045-5046. NDA 009470 Xylocaine Viscous (lidocaine hydrochloride (HCl)) Solution Fresenius Kabi USA LLC, Three Corporate Dr., Lake Zurich, IL 60047. NDA 009698 Miltown (meprobamate) Tablets, 200 milligrams (mg) and 400 mg Meda Pharmaceuticals, Inc., 265 Davidson Ave., Suite 300, Somerset, NJ 08873-4120. NDA 009939 Senokot Granules (sennosides), 15 mg Purdue Products, L.P., One Stamford Forum, Stamford, CT 06901. NDA 010382 Tempra (acetaminophen) Syrup, 160 mg/5 milliliters (mL) Bristol-Myers Squibb Co., P.O. Box 4000, Princeton, NJ 88543-4000. NDA 011228 Liquamar (phenprocoumon) Tablets Organon USA Inc., Subsidiary of Merck & Co., Inc., 2000 Galloping Hill Rd., Kenilworth, NJ 07033. NDA 011613 Ionamin (phentermine resin complex) Capsules, 15 mg and 30 mg UCB, Inc., 1950 Lake Park Dr., Smyrna, GA 30080. NDA 011738 Numorphan (oxymorphone HCl) Suppositories, 5 mg Endo Pharmaceuticals, Inc., 100 Endo Blvd., Chadds Ford, PA 19317. NDA 012365 Soma Compound (carisoprodol and aspirin) Tablets Meda Pharmaceuticals, Inc. NDA 012940 Isordil (isosorbide dinitrate) Sublingual Tablets, 2.5 mg, 5 mg, and 10 mg Valeant International Bermuda, c/o Valeant Pharmaceuticals North America, LLC, 400 Somerset Corporate Blvd., Bridgewater, NJ 08807. NDA 013483 Drixoral/Disophrol (dexbrompheniramine maleate and pseudoephedrine sulfate) Extended-Release Tablets, 6 mg/120 mg Merck Consumer Care, 556 Morris, Ave., Summit, NJ 07901. NDA 014005 Maxibolin (ethylestrenol) Tablets Organon USA Inc. NDA 017087 Ethrane (enflurane USP) Baxter Healthcare Corp., 32650 N. Wilson Rd., Round Lake, IL 60073. NDA 017689 Methadone HCl Syrup Sandoz, Inc., 4700 Sandoz, Dr., Wilson, NC 27893. NDA 018766 Ansaid (flurbiprofen) Tablets, 50 mg and 100 mg Pharmacia & Upjohn Co., c/o Pfizer, Inc., 235 East 42nd St., New York, NY 10017. NDA 018812 Sulfamethoxazole and Trimethoprim Oral Suspension USP, 200 mg/5 mL and 40 mg/5 mL Teva Pharmaceuticals USA, Inc., 1090 Horsham Rd., P.O. Box 1090, North Wales, PA 19454. NDA 019304 Tricor (fenofibrate) Micronized Capsules, 67 mg, 134 mg, and 200 mg AbbVie Inc., 1 N. Waukegan Rd., Dept. PA77/Bldg. AP30, North Chicago, IL 60064. NDA 019384 Noroxin (norfloxacin) Tablets, 400 mg Merck Sharp & Dohme Corp., 351 North Sumneytown Pike, P.O. Box 1000, North Wales, PA 19454. NDA 020005 Cardene SR (nicardipine HCl) Extended-Release Capsules, 30 mg, 45 mg, and 60 mg Chiesi USA, Inc., 1255 Crescent Green Dr., Suite 250, Cary, NC 27518. NDA 020073 Romazicon (flumazenil) Injection Hoffman-LaRoche, Inc., c/o Genetech, Inc., 1 DNA Way MS #241B, South San Francisco, CA 94080-4900. NDA 020084 Iobenguane Sulfate I-131 Injection, 2.3 millicuries Pharmalucence, 10 DeAngelo Dr., Bedford, MA 01730. NDA 020107 Novamine (amino acids) Injection Baxter Healthcare Corp. NDA 020229 Leustatin (cladribine) Injection, 1 mg/mL Janssen Pharmaceuticals Inc., 920 Route 202 South, P.O. Box 300, Raritan, NJ 08869-0602. NDA 020251 Zantac (ranitidine HCl) Effervescent Tablets, 25 mg and 150 mg Zantac (ranitidine HCl) Effervescent Granules, 150 mg Glaxo Group Limited, England d/b/a GlaxoSmithKline, Five Moore Dr., P.O. Box 13398, Research Triangle Park, NC 27709. NDA 020312 Univasc (moexipril HCl) Tablets, 7.5 mg and 15 mg UCB, Inc. NDA 020346 Zyrtec (cetirizine HCl) Syrup, 1 mg/mL Johnson and Johnson Consumer Inc., McNeil Consumer Healthcare Division, 7050 Camp Hill Rd., Fort Washington, PA 19034-2299. NDA 020410 Gastromark (ferumoxsil) Oral Suspension AMAG Pharmaceuticals, 100 Haydon Ave., Lexington, MA 02421. NDA 020416 Feridex I.V. (ferumoxides) Injection Do. NDA 020460 Cytovene (ganciclovir) Capsules, 250 mg and 500 mg Roche Palo Alto LLC, c/o Genentech, Inc., 1 DNA Way, MS#241B, South San Francisco, CA 94080-4990. NDA 020575 DentiPatch (lidocaine) Noven Pharmaceuticals, Inc., 11960 SW. 144th St., Miami, FL 33186. NDA 020638 Vistide (cidofovir) Injection, Equivalent to (EQ) 75 mg base/mL Gilead Sciences, Inc., 333 Lakeside Dr., Foster City, CA 94404. NDA 020729 Uniretic (moexipril HCl and hydrochlorothiazide) Tablets, 7.5 mg/12.5 mg, 15 mg/12.5 mg, and 15 mg/25 mg UCB, Inc. NDA 021044 Palladone (hydromorphone HCl) Extended-Release Capsules Rhodes Pharmaceuticals L.P., 498 Washington St., Coventry, RI 02816. NDA 021046 Celexa (citalopram hydrobromide) EQ 10 mg base/5 mL Oral Solution Forest Laboratories, Inc., Harborside Financial Center, Plaza V, Suite 1900, Jersey, City, NJ 07311. NDA 021378 Combunox (Oxycodone HCl and Ibuprofen) Tablets Do. NDA 021671 DepoDur (morphine sulfate) Extended-Release Injection Pacira Pharmaceuticals, Inc., 10450 Science Center Dr., San Diego, CA 92121. NDA 021693 Rybix ODT (tramadol HCl) Orally Disintegrating Tablets Shionogi, Inc., 300 Campus Dr., Suite 300, Florham Park, NJ 07932. NDA 021768 Fludeoxyglucose F18 (FDG) Injection Weill Medical College of Cornell University, c/o Citigroup Biomedical Imaging Center, 516 East 72nd St., New York, NY 10021. NDA 022244 Lusedra (fospropofol disodium) Injection Eisai, Inc., 155 Tice Blvd., Woodcliff Lake, NJ 07677. NDA 022312 Docetaxel Injection Apotex Inc., c/o Apotex Corp., 2400 North Commerce Parkway, Suite 400, Weston, FL 33326. ANDA 040223 Acetaminophen and Codeine Phosphate Tablets USP, 300 mg/15 mg, 300 mg/30 mg, and 300 mg/60 mg Barr Laboratories, Inc., Subsidiary of Teva Pharmaceuticals USA, Inc., 425 Privet Rd., Horsham, PA 19044. ANDA 040297 Estradiol Tablets USP, 0.5 mg, 1 mg, and 2 mg Upsher-Smith Laboratories, Inc., 6701 Evenstad Dr., Maple Grove, MN 55369. ANDA 040311 Medroxyprogesterone Acetate Tablets USP, 2.5 mg, 5 mg, and 10 mg Duramed Pharmaceuticals, Inc., Subsidiary of Teva Pharmaceuticals USA Inc., 425 Privet Rd., Horsham, PA 19044. ANDA 040318 Meperidine HCl Tablets USP, 50 mg and 100 mg Do. ANDA 040472 Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, and Amphetamine Sulfate Tablets Teva Pharmaceuticals USA, Inc., 425 Privet Rd., Horsham, PA 19044. NDA 050143 Chloromycetin (chloramphenicol ophthalmic solution USP) Ophthalmic Solution Parkedale Pharmaceuticals, Inc., c/o King Pharmaceuticals, Inc., 501 Fifth St., Bristol, TN 37620. NDA 050156 Chloromycetin (chloramphenicol ophthalmic ointment USP) Ophthalmic Ointment, 1% Do. NDA 050443 Blenoxane (bleomycin sulfate) for Injection, EQ 15 units base/vial and 30 units base/vial Bristol-Myers Squibb Co. NDA 050630 Primaxin (imipenem and cilastatin sodium) Powder, EQ 500 mg base/vial; 500 mg/vial and EQ 750 mg base/vial; 750 mg/vial Merck, Sharp & Dohme Corp. ANDA 060306 Penicillin G Potassium Tablets USP Teva Pharmaceuticals USA, Inc. ANDA 060307 Penicillin G Potassium for Oral Solution USP Do. ANDA 061969 Cephalexin Capsules USP, EQ 250 mg base and EQ 500 mg base Ivax Pharmaceuticals, Inc., Subsidiary of Teva Pharmaceuticals USA, Inc. ANDA 062240 Cloxacillin Sodium Capsules USP, EQ 250 mg base and EQ 500 mg base Teva Pharmaceuticals USA, Inc. ANDA 062252 Oxacillin Sodium for Oral Solution USP, EQ 250 mg base/5 mL Teva Pharmaceuticals USA, Inc. ANDA 062268 Cloxacillin Sodium for Oral Solution USP, EQ 125 mg base/5 mL Do. ANDA 062653 Doryx (doxycycline hyclate) Delayed-Release Capsules, EQ 100 mg base Warner Chilcott Co., LLC, c/o Warner Chilcott (US), LLC, 100 Enterprise Dr., Rockaway, NJ 07866. ANDA 062670 Nystatin Oral Suspension USP, 100,000 units/mL Teva Pharmaceuticals USA, Inc. ANDA 062683 Cephradine Capsules USP, 250 mg and 500 mg Do. ANDA 062695 Cefadroxil Capsules USP, EQ 500 mg base Do. ANDA 062751 Erythromycin Pledgets USP, 2% Ivax Pharmaceuticals, Inc., Subsidiary of Teva Pharmaceuticals USA, Inc. ANDA 062760 Cephalexin Capsules USP, EQ 250 mg base Teva Pharmaceuticals USA, Inc. ANDA 062761 Cephalexin Capsules USP, EQ 500 mg base Do. ANDA 062766 Cefadroxil Capsules USP, EQ 500 mg base Ivax Pharmaceuticals, Inc., Subsidiary of Teva Pharmaceuticals USA, Inc. ANDA 062767 Cephalexin for Oral Suspension USP, EQ 125 mg base/5 mL Teva Pharmaceuticals USA, Inc. ANDA 062768 Cephalexin for Oral Suspension USP, EQ 250 mg base/5 mL Do. ANDA 062775 Cephalexin Capsules USP, EQ 500 mg base Barr Laboratories, Inc., Subsidiary of Teva Pharmaceuticals USA, Inc. ANDA 062853 Amoxicillin Capsules USP, 250 mg Teva Pharmaceuticals USA, Inc. ANDA 062854 Amoxicillin Capsules USP, 500 mg Do. ANDA 062946 Amoxicillin for Oral Suspension USP, 125 mg/5 mL Do. ANDA 063001 Amoxicillin for Oral Suspension USP, 250 mg/5 mL Do. ANDA 063018 Cefazolin Sodium for Injection USP, EQ 5 grams (g) base/vial and EQ 10 g base/vial Do. ANDA 063027 Clindamycin HCl Capsules USP, EQ 75 mg base Do. ANDA 063030 Amoxicillin Capsules USP, 250 mg Do. ANDA 063031 Amoxicillin Capsules USP, 500 mg Do. ANDA 064031 Amoxicillin Chewable Tablets, 125 mg and 250 mg Do. ANDA 064081 Cefaclor Capsules USP, EQ 250 mg base and EQ 500 mg base Do. ANDA 064145 Cefaclor Capsules USP, EQ 250 mg base and EQ 500 mg base Do. ANDA 065137 Clarithromycin Tablets USP, 250 mg and 500 mg Ivax Pharmaceuticals, Inc., Subsidiary of Teva Pharmaceuticals USA, Inc. ANDA 070006 Sulfamethoxazole and Trimethoprim Tablets USP, 400 mg/80 mg Mutual Pharmaceutical Co., Inc., 1100 Orthodox St., Philadelphia, PA 19124. ANDA 070007 Sulfamethoxazole and Trimethoprim Tablets USP, 800 mg/160 mg Do. ANDA 070232 Propranolol HCl Tablets USP, 10 mg Teva Pharmaceuticals USA, Inc. ANDA 070234 Propranolol HCl Tablets USP, 40 mg Do. ANDA 070266 Indo-Lemmon (Indomethacin Capsules USP), 25 mg Do. ANDA 070267 Indo-Lemmon (Indomethacin Capsules USP), 50 mg Do. ANDA 070469 Ibuprohn (Ibuprofen Tablets USP), 400 mg Ohm Laboratories, Inc., c/o Ranbaxy Inc., 600 College Rd. East, Princeton, NJ 08540. ANDA 070618 Potassium Chloride Extended-Release Tablets USP, 8 milliequivalents Copley Pharmaceutical, Inc., Subsidiary of Teva Pharmaceuticals USA, Inc., 425 Privet Rd., Horsham, PA 19044. ANDA 070660 Metoclopramide HCl Tablets USP, EQ 10 mg base Mutual Pharmaceutical Co., Inc. ANDA 071145 Ibuprofen Tablets USP Ivax Pharmaceuticals, Inc., Subsidiary of Teva Pharmaceuticals USA, Inc. ANDA 071146 Ibuprofen Tablets USP, 600 mg Do. ANDA 071184 Thiothixene HCl Oral Solution USP, EQ 5 mg base/mL Teva Pharmaceuticals USA, Inc. ANDA 071342 Indomethacin Capsules USP, 25 mg Do. ANDA 071343 Indomethacin Capsules USP, 50 mg Do. ANDA 072438 Fenoprofen Calcium Capsules USP, EQ 300 mg base Par Pharmaceutical, Inc., One Ram Ridge Rd., Spring Valley, NY 10977. ANDA 072522 Fluocinonide Topical Solution USP, 0.05% Teva Pharmaceuticals USA, Inc. ANDA 072600 Clofibrate Capsules USP, 500 mg Do. ANDA 072692 Norethindrone and Ethinyl Estradiol Tablets USP, 0.5 mg/0.035 mg Barr Laboratories, Inc., Subsidiary of Teva Pharmaceuticals, USA, Inc. ANDA 072999 Dopamine HCl Injection USP, 200 mg/5 mL Teva Parenteral Medicines, Inc., 425 Privet Rd., Horsham, PA 19044. ANDA 073005 Cinoxacin Capsules USP, 250 mg Teva Pharmaceuticals USA, Inc. ANDA 073006 Cinoxacin Capsules USP, 500 mg Do. ANDA 073043 Baclofen Tablets USP, 10 mg Do. ANDA 073044 Baclofen Tablets USP, 20 mg Do. ANDA 073099 Leucovorin Calcium Tablets USP, EQ 5 mg base Pharmachemie B.V., Subsidiary of Teva Pharmaceuticals USA, Inc., 425 Privet Rd., Horsham, PA 19044. ANDA 073101 Leucovorin Calcium Tablets USP, EQ 25 mg base Do. ANDA 073141 Ibuprofen Tablets USP, 200 mg Teva Pharmaceuticals USA, Inc. ANDA 073315 Atenolol Tablets USP, 50 mg Do. ANDA 073316 Atenolol Tablets USP, 100 mg Do. ANDA 073343 Ibuprofen Tablets USP, 400 mg Do. ANDA 073344 Ibuprofen Tablets USP, 600 mg Do. ANDA 073345 Ibuprofen Tablets USP, 800 mg Do. ANDA 073515 Ketoprofen Capsules USP, 25 mg Do. ANDA 073679 Diflunisal Tablets USP, 250 mg Do. ANDA 074067 Diltiazem HCl Tablets USP, 30 mg, 60 mg, 90 mg, and 120 mg Do. ANDA 074107 Atenolol and Chlorthalidone Tablets USP, 50 mg/25 mg and 100 mg/25 mg Pliva, Inc., Subsidiary of Teva Pharmaceuticals USA, Inc., 425 Privet Rd., Horsham, PA 19044. ANDA 074120 Atenolol Tablets USP, 50 mg and 100 mg Teva Pharmaceuticals USA, Inc. ANDA 074123 Pindolol Tablets USP, 5 mg and 10 mg G&W Laboratories, Inc., 111 Coolidge St., South Plainfield, NJ 07080. ANDA 074124 Ciprofloxacin HCl Tablets, EQ 250 mg base, EQ 500 mg base, and EQ 750 mg base Barr Laboratories, Inc., Subsidiary of Teva Pharmaceuticals USA, Inc. ANDA 074143 Metoprolol Tartrate Tablets USP, 50 mg and 100 mg Teva Pharmaceuticals USA, Inc. ANDA 074216 Naproxen Tablets, 250 mg, 375 mg, and 500 mg Do. ANDA 074294 Alprazolam Tablets USP, 0.25 mg, 0.5 mg, 1 mg, and 2 mg Ivax Pharmaceuticals, Inc., Subsidiary of Teva Pharmaceuticals USA, Inc. ANDA 074333 Metoprolol Tartrate Tablets USP, 50 mg and 100 mg Teva Pharmaceuticals USA, Inc. ANDA 074357 Trazodone HCl Tablets USP, 150 mg Do. ANDA 074365 Cimetidine Tablets USP, 200 mg, 300 mg, 400 mg, and 800 mg Do. ANDA 074446 Terazosin HCl Tablets, EQ 1 mg base, EQ 2 mg base, EQ 5 mg base, and EQ 10 mg base Do. ANDA 074459 Diclofenac Sodium Delayed-Release Tablets USP, 25 mg, 50 mg, and 75 mg Do. ANDA 074476 Hydroxyurea Capsules USP, 500 mg Roxane Laboratories, Inc., 1809 Wilson Rd., Columbus, OH 43228. ANDA 074504 Tamoxifen Citrate Tablets USP, EQ 10 mg base and EQ 20 mg base Teva Pharmaceuticals USA, Inc. ANDA 074537 Selegiline HCl Tablets USP, 5 mg G&W Laboratories, Inc. ANDA 074555 Cholestyramine for Oral Suspension USP Teva Pharmaceuticals, USA, Inc. ANDA 074674 Acyclovir Capsules USP, 200 mg Ivax Pharmaceuticals, Inc., Subsidiary of Teva Pharmaceuticals USA, Inc. ANDA 074745 Megestrol Acetate Tablets USP, 40 mg Teva Pharmaceuticals USA, Inc. ANDA 074771 Cholestyramine for Oral Suspension USP Do. ANDA 074847 Etodolac Tablets USP, 400 mg and 500 mg Do. ANDA 074883 Etodolac Tablets USP, 400 mg and 500 mg Ivax Pharmaceuticals, Inc., Subsidiary of Teva Pharmaceuticals USA, Inc. ANDA 074895 Amiodarone HCl Tablets, 200 mg Teva Pharmaceuticals USA, Inc. ANDA 074914 Acyclovir Capsules USP, 200 mg Do. ANDA 074989 Labetalol HCl Tablets USP, 100 mg, 200 mg, and 300 mg Do. ANDA 075021 Acyclovir Tablets USP, 400 mg and 800 mg Do. ANDA 075557 Ranitidine HCl Capsules, EQ 150 mg base and EQ 300 mg base Do. ANDA 075686 Bisoprolol Fumarate and Hydrochlorothiazide Tablets USP, 2.5 mg/6.25 mg, 5 mg/6.25 mg, and 10 mg/6.25 mg Do. ANDA 075719 Sertraline HCl Tablets USP, EQ 25 mg base, EQ 50 mg base, and EQ 100 mg base Do. ANDA 075726 Pemoline Tablets, 18.75 mg, 37.5 mg, and 75 mg Mallinckrodt Inc., 675 McConnell Blvd., Hazelwood, MO 63042. ANDA 075740 Tamoxifen Citrate Tablets USP, EQ 10 mg base and EQ 20 mg base Ivax Pharmaceuticals, Inc., Subsidiary of Teva Pharmaceuticals USA, Inc. ANDA 075810 Fluoxetine HCl Tablets , EQ 10 mg base Barr Laboratories, Inc., Subsidiary of Teva Pharmaceuticals USA, Inc. ANDA 075823 Calcitriol Injection USP, 0.001 mg/mL and 0.002 mg/mL Teva Parenteral Medicines, Inc. ANDA 075827 Gabapentin Tablets USP, 600 mg and 800 mg Teva Pharmaceuticals USA, Inc. ANDA 075862 Levonorgestrel and Ethinyl Estradiol Tablets USP, 0.1 mg/0.02 mg Barr Laboratories, Inc., Subsidiary of Teva Pharmaceuticals USA, Inc. ANDA 075865 Fluoxetine HCl Tablets , EQ 10 mg base and EQ 40 mg base Ivax Pharmaceuticals, Inc., Subsidiary of Teva Pharmaceuticals USA, Inc. ANDA 075971 Metformin HCl Tablets USP, 500 mg, 850 mg, and 1 g Barr Laboratories, Inc., Subsidiary of Teva Pharmaceuticals USA, Inc. ANDA 075975 Metformin HCl Tablets USP, 500 mg, 625 mg, 750 mg, 850 mg, and 1 g Ivax Pharmaceuticals, Inc., Subsidiary of Teva Pharmaceuticals USA, Inc. ANDA 076094 Pergolide Mesylate Tablets, EQ 0.05 mg base, EQ 0.25 mg base, and EQ 1 mg base Do. ANDA 076184 Alendronate Sodium Tablets USP, EQ 35 mg tablets and EQ 70 mg tablets Teva Pharmaceuticals USA, Inc. ANDA 076198 Balziva-21 Tablets (norethindrone and ethinyl estradiol tablets USP), 0.4 mg/0.035 mg Barr Laboratories, Inc., Subsidiary of Teva Pharmaceuticals USA, Inc. ANDA 076244 Mirtazapine Tablets USP, 15 mg, 30 mg, and 45 mg Ivax Pharmaceuticals, Inc., Subsidiary of Teva Pharmaceuticals USA, Inc. ANDA 076251 Fluoxetine HCl Capsules, EQ 40 mg base Barr Laboratories, Inc., Subsidiary of Teva Pharmaceuticals USA, Inc. ANDA 076328 Metformin HCl Tablets USP, 500 mg, 850 mg, and 1 g Teva Pharmaceuticals USA, Inc. ANDA 076340 Finasteride Tablets USP, 5 mg Ivax Pharmaceuticals, Inc., Subsidiary of Teva Pharmaceuticals USA, Inc. ANDA 076426 Ciprofloxacin HCl Tablets , EQ 100 mg base, EQ 250 mg base, EQ 500 mg base, and EQ 750 mg base Pliva, Inc., Subsidiary of Teva Pharmaceuticals USA, Inc. ANDA 076496 Metformin HCl Extended-Release Tablets USP, 500 mg Barr Pharmaceuticals, Inc., Subsidiary of Teva Pharmaceuticals USA, Inc. ANDA 076545 Metformin HCl Extended-Release Tablets USP, 500 mg Ivax Pharmaceuticals, Inc., Subsidiary of Teva Pharmaceuticals USA, Inc. ANDA 076840 Sumatriptan Succinate Tablets, EQ 25 mg base, EQ 50 mg base, and EQ 100 mg base Teva Pharmaceuticals USA, Inc. ANDA 076880 Nicotine Polacrilex Gum USP, EQ 2 mg base Ivax Pharmaceuticals, Inc., Subsidiary of Teva Pharmaceuticals USA, Inc. ANDA 076945 Fosinopril Sodium and Hydrochlorothiazide Tablets USP, 10 mg/12.5 mg and 20 mg/12.5 mg Teva Pharmaceuticals USA, Inc. ANDA 077020 Cilostazol Tablets USP, 100 mg Ivax Pharmaceuticals, Inc., Subsidiary of Teva Pharmaceuticals USA, Inc. ANDA 077082 Paroxetine Tablets USP, EQ 10 mg base, EQ 20 mg base, EQ 30 mg base, and EQ 40 mg base Teva Pharmaceuticals USA, Inc. ANDA 077775 Fentanyl Extended-Release Film, 25 micrograms (mcg), 50 mcg, 75 mcg, and 100 mcg Noven, Pharmaceuticals, Inc. ANDA 077850 Nicotine Polacrilex Gum USP, EQ 4 mg base Ivax Pharmaceuticals, Inc., Subsidiary of Teva Pharmaceuticals USA, Inc. ANDA 077898 Cilostazol Tablets USP, 50 mg and 100 mg Pliva Hrvatska DOO, c/o Teva Pharmaceuticals USA, Inc.,425 Privet Rd., Horsham, PA 19044. ANDA 077973 Bicalutamide Tablets USP, 50 mg Synthon Pharmaceuticals, Inc., 9000 Development Dr., P.O. Box 110487, Research Triangle Park, NC 27709. ANDA 077995 Bicalutamide Tablets UPS, 50 mg Kudco Ireland Limited, c/o Kremers Urban Pharmaceuticals, Inc., 1101 C Ave. West, Seymour, IN 47274. ANDA 078079 Ciclopirox Topical Solution USP, 8% Teva Pharmaceuticals USA, Inc. ANDA 078221 Granisetron HCl Tablets USP, EQ 1 mg base Barr Laboratories, Inc., Subsidiary of Teva Pharmaceuticals USA, Inc. ANDA 078263 Perindopril Erbumine Tablets, 2 mg, 4 mg, and 8 mg Lupin Limited, c/o Lupin Pharmaceuticals, Inc., 111 South Calvert St., Harborplace Tower, 21st Floor, Baltimore, MD 21202. ANDA 078567 Ciclopirox Topical Solution USP, 8% Mylan Pharmaceuticals Inc., 781 Chestnut Ridge Rd., P.O. Box 4310, Morgantown, WV 26504. ANDA 078666 Levonorgestrel Tablets, 0.75 mg Watson Laboratories, Inc., 311 Bonnie Circle, Corona, CA 92880. ANDA 078773 Atorvastatin Calcium Tablets, EQ 10 mg base, EQ 20 mg (base), EQ 40 mg base, and EQ 80 mg base Teva Pharmaceuticals USA, Inc. ANDA 080400 Hydrocortisone Cream USP Do. ANDA 080828 Hydrocortisone Acetate Ophthalmic Ointment USP, 0.5% Fera Pharmaceuticals LLC, 134 Birch Hill Rd., Locust Valley, NY 11560. ANDA 083919 Meprobamate Tablets USP, 600 mg Meda Pharmaceuticals Inc., 265 Davidson Ave., Suite 400, Somerset, NJ 08873. ANDA 085022 Hydrochlorothiazide Tablets USP, 100 mg Ivax Pharmaceuticals, Inc., Subsidiary of Teva Pharmaceuticals USA, Inc. ANDA 085855 A-Methapred (methylprednisolone sodium succinate for Injection USP), EQ 125 mg base/vial Hospira, Inc. ANDA 086750 Ergotamine Tartrate Sublingual Tablets USP, 2 mg Organon USA, Inc. ANDA 087014 Orgatrax (hydroxyzine HCl Injection USP), 25 mg/mL and 50 mg/mL Do. ANDA 087264 Thioridazine HCl Tablets USP, 25 mg Mutual Pharmaceutical Co., Inc. ANDA 087665 Sulfinpyrazone Tablets USP, 100 mg Barr Pharmaceuticals, Inc., Subsidiary of Teva Pharmaceuticals USA, Inc. ANDA 087666 Sulfinpyrazone Capsules USP, 200 mg Do. ANDA 087760 Hydroxyzine Pamoate Capsules USP, EQ 50 mg HCl Ivax Pharmaceuticals, Inc., Subsidiary of Teva Pharmaceuticals USA, Inc. ANDA 087761 Hydroxyzine Pamoate Capsules USP, EQ 25 mg HCl Do. ANDA 088370 Thioridazine HCl Tablets USP, 50 mg Mutual Pharmaceutical Co., Inc. ANDA 088375 Thioridazine HCl Tablets USP, 10 mg Do. ANDA 088379 Thioridazine HCl Tablets USP, 100 mg Do. ANDA 088469 Dexamethasone Sodium Phosphate Injection USP, EQ 10 mg Phosphate/mL Fresenius Kabi USA, LLC. ANDA 088900 Doxylamine Succinate Tablets USP, 25 mg Copley Pharmaceuticals, Inc., Subsidiary of Teva Pharmaceuticals USA, Inc. ANDA 088902 Chlorthalidone Tablets USP, 25 mg Barr Laboratories, Inc., Subsidiary of Teva Pharmaceuticals USA, Inc. ANDA 088903 Chlorthalidone Tablets USP, 50 mg Do. ANDA 088974 Procainamide HCl Extended-Release Tablets USP, 500 mg ANI Pharmaceuticals, Inc.,. ANDA 089109 Promethazine HCl Tablets USP, 25 mg Teva Pharmaceuticals USA, Inc. ANDA 090299 Melphalan HCl for Injection, EQ 50 mg base/vial Mylan Institutional LLC, 4901 Hiawatha Dr., Rockford, IL 61103. ANDA 090924 Ibutilide Fumarate Injection, 0.1 mg/mL Do. ANDA 091242 Anastrozole Tablets USP, 1 mg Impax Laboratories, Inc., 30831 Huntwood Ave., Hayward, CA 94544. ANDA 091638 Letrozole Tablets USP, 2.5 mg Do. ANDA 200792 Oxymorphone HCl Extended-Release Tablets, 5 mg, 7.5 mg, 10 mg, 15 mg, 20 mg, 30 mg, and 40 mg Par Pharmaceutical, Inc. ANDA 204538 Zidovudine Injection USP, 10 mg/mL Liaoning Chengda Biotechnology Co., Ltd., c/o Ruby Pharma, Inc., 116 Village Blvd, Suite 200, Princeton, NJ 08540.

    Therefore, under section 505(e) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 355(e)) and under authority delegated to the Director, Center for Drug Evaluation and Research, by the Commissioner, approval of the applications listed in table 1 in this document, and all amendments and supplements thereto, is hereby withdrawn, effective November 3, 2016. Introduction or delivery for introduction into interstate commerce of products without approved new drug applications violates section 301(a) and (d) of the FD&C Act (21 U.S.C. 331(a) and (d)). Drug products that are listed in table 1 that are in inventory on the date that this notice becomes effective (see the DATES section) may continue to be dispensed until the inventories have been depleted or the drug products have reached their expiration dates or otherwise become violative, whichever occurs first.

    Dated: September 27, 2016. Leslie Kux, Associate Commissioner for Policy.
    [FR Doc. 2016-23893 Filed 10-3-16; 8:45 am] BILLING CODE 4164-01-P
    DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2016-N-2880] Microbiology Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments AGENCY:

    Food and Drug Administration, HHS.

    ACTION:

    Notice; establishment of a public docket; request for comments.

    SUMMARY:

    The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Microbiology Devices Panel of the Medical Devices Advisory Committee. The general function of the committee is to provide advice and recommendations to the Agency on FDA's regulatory issues. The meeting will be open to the public. FDA is establishing a docket for public comment on this document.

    DATES:

    The meeting will be held on November 9 and 10, 2016, from 8 a.m. to 6 p.m.

    ADDRESSES:

    Gaithersburg Holiday Inn Ballroom, 2 Montgomery Village Ave., Gaithersburg, MD 20879. The hotel's telephone number is 301-948-8900. Answers to commonly asked questions including information regarding special accommodations due to a disability, visitor parking, and transportation may be accessed at: http://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm408555.htm.

    You may submit comments as follows:

    Electronic Submissions

    Submit electronic comments in the following way:

    Federal eRulemaking Portal: http://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to http://www.regulations.gov will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else's Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on http://www.regulations.gov.

    • If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see “Written/Paper Submissions” and “Instructions”).

    Written/Paper Submissions

    Submit written/paper submissions as follows:

    Mail/Hand delivery/Courier (for written/paper submissions): Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

    • For written/paper comments submitted to the Division of Dockets Management, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in “Instructions.”

    Instructions: All submissions received must include the Docket No. FDA-2016-N-2880 for “Microbiology Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments.” Received comments will be placed in the docket and, except for those submitted as “Confidential Submissions,” publicly viewable at http://www.regulations.gov or at the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.

    • Confidential Submissions—To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states “THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.” The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on http://www.regulations.gov. Submit both copies to the Division of Dockets Management. If you do not wish your name and contact information to be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify this information as “confidential.” Any information marked as “confidential” will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law. For more information about FDA's posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: http://www.fda.gov/regulatoryinformation/dockets/default.htm.

    Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to http://www.regulations.gov and insert the docket number, found in brackets in the heading of this document, into the “Search” box and follow the prompts and/or go to the Division of Dockets Management, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

    FOR FURTHER INFORMATION CONTACT:

    Aden Asefa, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993, [email protected], 301-796-0400, or FDA Advisory Committee Information Line, 1-800-741-8138 (301-443-0572 in the Washington, DC area). A notice in the Federal Register about last minute modifications that impact a previously announced advisory committee meeting cannot always be published quickly enough to provide timely notice. Therefore, you should always check the Agency's Web site at http://www.fda.gov/AdvisoryCommittees/default.htm and scroll down to the appropriate advisory committee meeting link, or call the advisory committee information line to learn about possible modifications before coming to the meeting.

    SUPPLEMENTARY INFORMATION:

    Agenda: On November 9, 2016, during session one, the committee will discuss and make recommendations regarding the reclassification of quantitative Cytomegalovirus (CMV) viral load devices from class III (Premarket approval) to class II (510(k)). A nucleic acid-based in vitro diagnostic device for the quantitation of CMV viral load, within the context of transplant patient management, is a post-amendment device classified into class III under section 513(f)(1) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act)(21 U.S.C. 360c(f)(1). To date, the following product code has been established for CMV viral load devices: PAB (CMV DNA Quantitative Assay). During session two, the committee will discuss and make recommendations regarding the appropriate initial classification for qualitative or quantitative viral load devices for Epstein-Barr virus, BK virus, JC virus, Human Herpesvirus 6, and Adenovirus infections. FDA is seeking expert recommendations to assess the potential risks and benefits of these devices when used in patients following solid-organ or stem cell transplantation.

    On November 10, 2016, the committee will discuss and make recommendations to FDA regarding how FDA might handle a future premarket notification (510(k)) submission for a Procalcitonin (PCT) test. One test that FDA previously reviewed and cleared was the VIDAS B·R·A·H·M·S PCT (Procalcitonin) test which is an in vitro diagnostic test for measuring procalcitonin from human serum or plasma. The test was cleared with an indication for use as follows:

    • VIDAS B·R·A·H·M·S PCT (PCT) is an automated test for use on the instruments of the VIDAS family for the determination of human procalcitonin in human serum or plasma (lithium heparinate) using the Enzyme-Linked Fluorescent Assay technique.

    • VIDAS B·R·A·H·M·S PCT (PCT) is intended for use in conjunction with other laboratory findings and clinical assessments to aid in the risk assessment of critically ill patients on their first day of ICU admission for progression to severe sepsis and septic shock.

    • VIDAS B·R·A·H·M·S PCT (PCT) is also intended for use to determine the change of PCT level over time as an aid in assessing the cumulative 28-day risk of all-cause mortality in conjunction with other laboratory findings and clinical assessments for patients diagnosed with severe sepsis or septic shock in the intensive care unit (ICU) or when obtained in the emergency department or other medical wards prior to ICU admission.

    • Procalcitonin (PCT) is a biomarker associated with the inflammatory response to bacterial infection that aids in the risk assessment of critically ill patients on their first day of ICU admission for progression to severe sepsis and septic shock. The percent change in PCT level over time also aids in the prediction of cumulative 28-day mortality in patients with severe sepsis and septic shock.

    PCT levels on the first day of ICU admission above 2.0 nanograms per milliliter (ng/mL) are associated with a higher risk for progression to severe sepsis and/or septic shock than PCT levels below 0.5 ng/mL.

    • A PCT level that declines ≤80 percent from the day that severe sepsis or septic shock was clinically diagnosed (day 0) to 4 days after clinical diagnosis (day 4) is associated with higher cumulative 28-day risk of all-cause mortality than a decline >80 percent.

    • The combination of the first PCT level (≤2.0 ng/mL or >2.0 ng/mL) at initial diagnosis of severe sepsis or septic shock with the patient's clinical course and the change in PCT level over time until day 4 provides important additional information about the mortality risk.

    • The PCT level on day 1 (the day after severe sepsis or septic shock is first clinically diagnosed) can be used to calculate the percent change in PCT level at day 4 if the day 0 measurement is unavailable.

    FDA anticipates receiving a 510(k) submission for PCT test in which the intended use could be modified to add an indication for use as an aid in the antibiotic management of patients with suspected lower respiratory tract infection, an indication for use as an aid in the antibiotic management of patients being treated with antibiotics for confirmed or documented sepsis, or both. FDA is seeking feedback from the committee and interested parties to assess the evidence in support of the hypothetical changes and the overall benefits and risks from this proposed new indication for use in clinical practice, including feedback on whether any additional mitigations are necessary.

    FDA intends to make background material available to the public no later than 2 business days before the meeting. If FDA is unable to post the background material on its Web site prior to the meeting, the background material will be made publicly available at the location of the advisory committee meeting, and the background material will be posted on FDA's Web site after the meeting. Background material is available at http://www.fda.gov/AdvisoryCommittees/Calendar/default.htm. Scroll down to the appropriate advisory committee meeting link.

    Procedure: Interested persons may present data, information, or views, orally or in writing, on issues pending before the committee. Written submissions may be made to the contact person on or before October 27, 2016. Oral presentations from the public will be scheduled between approximately 8:30 a.m. and 9:30 a.m. on November 9, 2016, and between approximately 1 p.m. and 2 p.m. on November 10, 2016. Those individuals interested in making formal oral presentations should notify the contact person and submit a brief statement of the general nature of the evidence or arguments they wish to present, the names and addresses of proposed participants, and an indication of the approximate time requested to make their presentation on or before October 19, 2016. Time allotted for each presentation may be limited. If the number of registrants requesting to speak is greater than can be reasonably accommodated during the scheduled open public hearing session, FDA may conduct a lottery to determine the speakers for the scheduled open public hearing session. The contact person will notify interested persons regarding their request to speak by October 20, 2016.

    Persons attending FDA's advisory committee meetings are advised that the Agency is not responsible for providing access to electrical outlets.

    FDA is establishing a docket for public comment on this document. The docket number is FDA-2016-N-2880. The docket will close on December 6, 2016. Comments received on or before October 26, 2016, will be provided to the committee. Comments received after that date will be taken into consideration by the Agency.

    FDA welcomes the attendance of the public at its advisory committee meetings and will make every effort to accommodate persons with disabilities. If you require accommodations due to a disability, please contact Artair Mallett at [email protected] or 301-796-9638, at least 7 days in advance of the meeting. For press inquiries, please contact the Office of Media Affairs at [email protected] or 301-796-4540.

    FDA is committed to the orderly conduct of its advisory committee meetings. Please visit our Web site at http://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm111462.htm for procedures on public conduct during advisory committee meetings.

    Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. app. 2).

    Dated: September 28, 2016. Janice M. Soreth, Acting Associate Commissioner, Special Medical Programs.
    [FR Doc. 2016-23895 Filed 10-3-16; 8:45 am]